Note: Descriptions are shown in the official language in which they were submitted.
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TREATMENT OF HYPERTENSION
Technical field
The present disclosure relates to a technology for treating patients suffering
from hypertension, and
more specifically to systems and methods for causing electrically induced
vasodilation of the renal
artery.
Background
Hypertension, commonly referred to as 'high blood pressure' is a medical
condition in which the
blood pressure is persistently elevated. In most people suffering from
hypertension, increased
resistance to blood flow accounts for the high pressure while cardiac output
remains normal. The
increased resistance that must be overcome to push blood through the
circulatory system and create
flow is sometimes referred to as vascular resistance or systemic vascular
resistance. There are
many factors that are known to alter the vascular resistance. Vascular
compliance is determined by
the muscle tone in the smooth muscle tissue of the tunica media and the
elasticity of the elastic
fibers there. However, the muscle tone is subject to continual homeostatic
changes by hormones
and cell signaling molecules that induce vasodilation and vasoconstriction to
keep blood pressure
and blood flow within reference ranges.
Hypertension has been identified as an important preventable risk factor for
premature
death worldwide. It increases the risk of ischemic heart disease, strokes,
peripheral vascular
disease, and other cardiovascular diseases, including heart failure, aortic
aneurysms, and chronic
kidney disease.
Hypertension is commonly treated by antihypertensive agents such as beta
blockers,
angiotensin receptor blockers and renin inhibitors, as well as by lifestyle
changes including weight
loss, physical exercise, decreased salt intake and a healthy diet.
However, due to the ever-growing part of the population suffering from
hypertension, there
is a need for improved and alternative treatments.
Summary
It is an object of the present invention to provide improved technologies and
methods for treating
hypertension. This is achieved by the subject-matter defined in the
independent claims.
Advantageous embodiments are defined in the dependent claims.
According to an embodiment, a system for treating a patient with hypertension
is provided,
comprising a stimulation device comprising an electrode arrangement configured
to deliver an
electric stimulation signal to a wall portion of a renal artery of the patent
to affect a vasomotor tone
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of a smooth muscle tissue of the renal artery, an implantable source of energy
configured to
energize the electrode arrangement, and a control unit operably connected to
the stimulation
device. The control unit is configured to control an operation of the
stimulation device such that the
electric stimulation signal causes vasodilation of the renal artery.
According to an embodiment, a medical device is provided, comprising an
electrode
arrangement configured to deliver an electric stimulation signal to a wall
portion of a renal artery of
the patient to affect a vasomotor tone of a smooth muscle tissue of the renal
artery, and a remote
unit operably connected to the electrode arrangement and configured to
generate the electric
stimulation signal such that the electric stimulation signal causes
vasodilation of the renal artery.
1 0 .. The remote unit is configured to be secured to a tissue wall of the
patient, and comprises a first unit
configured to be implanted at a first side of the tissue wall of the patient,
a second unit configured
to be implanted at a second side of the tissue wall, and a connecting unit
configured to be
arranged to extend through the tissue wall and to be mechanically attached to
the first unit and the
second unit. The first unit and the second unit are provided with a shape and
size hindering them
from passing through the tissue wall.
According to an embodiment, a system for treating a patient suffering from
hypertension is
provided. The system comprises a stimulation device comprising an electrode
arrangement
configured to deliver an electric stimulation signal to a wall portion of a
renal artery of the patient
to affect a vasomotor tone of a smooth muscle tissue of the renal artery, an
implantable sensor
configured to generate a signal indicative of a blood pressure of the patient,
and a control unit
communicatively connected to the stimulation device and to the sensor device.
The control unit is
configured to control an operation of the stimulation device, based on the
signal generated by the
sensor device, such that the electric stimulation signal causes vasodilation
of the renal artery.
In an example, the electrode arrangement comprises a plurality of electrode
elements, each
of which being configured to engage and electrically stimulate the wall
portion of the renal artery
or a nerve innervating the renal artery.
In an example, the electrode arrangement is arranged on a surface portion of a
support
structure, and wherein the surface portion is configured to be placed on the
wall portion of the renal
artery or on the nerve innervating the renal artery.
In an example, the support structure comprises a cuff portion configured to be
arranged at
least partly around the wall portion of the renal artery or the nerve
innervating the renal artery.
In an example, the electrode arrangement is arranged on an inner surface of
the cuff
In an example, the electrode arrangement is configured to electrically
stimulate a sacral
nerve.
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In an example, the control unit is configured to generate a pulsed electrical
stimulation
signal for affecting the vasomotor tone of the smooth muscle tissue of the
renal artery.
In an example, the electrical stimulation signal comprises a frequency of 30
Hz or less,
such as 5-25 Hz, such as 10-20 Hz.
In an example, the electrical stimulation signal comprises a pulse width of
0.01-1 ms.
In an example, the electrical stimulation signal comprises a pulse amplitude
of 1-15 mA.
In an example, the system further comprises a signal damping device configured
to be
arranged at the parasympathetic nerve, at a position between the stimulation
device and the spinal
cord.
In an example, the signal damping device comprises an electrode arrangement
configured
to deliver an electric damping signal to the parasympathetic nerve, and
wherein the electric
damping signal is configured to at least partly counteract the electrical
stimulation signal generated
by the stimulation device.
In an example, the signal damping device further comprises a signal processing
means
configured to measure the electrical stimulation signal received at the signal
damping device and
generate the electric damping signal based on the received electrical
stimulation signal.
In an example, the control unit is configured to be communicatively connected
to a
wireless remote control.
In an example, the control unit comprises an internal signal transmitter
configured to
receive and transmit communication signals from/to an external signal
transmitter.
In an example, the sensor comprises a pressure sensor configured to be
arranged in a blood
vessel of the patient.
In an example, the sensor is configured to be arranged at an outer wall of a
blood vessel of
the patient.
In an example, the sensor is configured to measure a pressure pulse wave
transmitted from
the blood flow to the outer wall of the blood vessel.
In an example, the sensor comprises a strain gauge sensitive to strain in the
outer wall of
the blood vessel.
In an example, the sensor comprises a contact pressure sensor sensitive to a
pressing force
between the outer wall of the blood vessel and the pressure sensor.
In an example, the sensor comprises a doppler radar sensor configured to
measure the
blood pressure in the blood vessel.
In an example, the sensor comprises a light source and a light sensor, and
wherein the
signal is based on a light coupling efficiency between the light source and
the light sensor.
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In an example, the sensor is configured to generate a signal indicative of a
vascular
resistance in a portion of the circulatory system of the patient.
In an example, the sensor is a flow sensor configured to generate a signal
indicative of a
flow through a blood vessel
In an example, the system further comprises a blood pressure sensor configured
to generate
a signal indicating a blood pressure of the patient.
In an example, the blood pressure sensor is configured to determine a local
blood pressure
in the renal artery.
In an example, blood pressure sensor is configured to determine a systemic
blood pressure.
1 0 In an example, the control unit is configured to receive the signal
generated by the blood
pressure sensor.
In an example, the control unit is configured to control the operation of the
stimulation
device based on the received signal.
In an example, the control unit is configured to determine an estimated blood
pressure
based the on signal generated by the sensor, wherein the determined blood
pressure is a local blood
pressure in the renal artery or a systemic blood pressure.
In an example, the control unit is configured to compare the estimated blood
pressure with
a predetermined limit value, and in response to the estimated blood pressure
being below the limit
value, control the operation of the stimulation device to cause
vasoconstriction of the renal artery,
and
in response to the estimated blood pressure exceeding the limit value, control
the operation of the
stimulation device to cause vasodilation of the renal artery.
In an example, the control unit is configured to monitor, over time, the
estimated blood
pressure based on the signal generated by the sensor; and
in response to the estimated blood pressure sinking over time, control the
operation of the
stimulation device to cause vasoconstriction of the renal artery, and in
response to the estimated
blood pressure rising over time, control the operation of the stimulation
device to cause
vasodilation of the renal artery.
In an example, the control unit comprises an internal signal transmitter
configured to
receive and transmit communication signals from/to an external signal
transmitter.
In an example, the first unit has a first cross-sectional area in a first
plane and comprises a
first surface configured to engage a first tissue surface of the first side of
the tissue portion, the
second unit has a second cross-sectional area in a second plane and comprises
a second surface
configured to engage a second tissue surface of the second side of the tissue
portion, the connecting
unit has a third cross-sectional area in a third plane, and the third cross-
sectional area is smaller
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than the first and second cross-sectional areas, such that the first unit and
the second unit are
prevented from travelling through the tissue wall.
In an example, the connecting unit has a circular cross-section.
In an example, the connecting unit is hollow.
5 In an example, at least one of the first and second units is configured
to be threaded onto
the connecting unit.
In an example, the first and second unit forms a bolted joint with the
connecting unit.
In an example, the connecting unit is elastic.
In an example, the signal damping device is arranged in at least one of the
first unit, second
unit and the connecting unit.
In an example, the sensor is arranged in at least one of the first unit, the
second unit and the
connecting unit.
In an example, the source of energy is arranged in at least one of the first
unit, the second
unit and the connecting unit.
In an example, at least one of the first unit, the second unit and the
connecting unit
comprises a wireless receiver configured to receive energy transmitted from
outside the body of the
patient.
In an example, at least one of the first unit, the second unit and the
connecting unit
comprises a wireless transceiver for communicating wirelessly with an external
device.
In an example, the remote unit is configured to be implanted in a tissue wall
forming part
of at least one of:
the diaphragm,
the left or right crus,
the medial or lateral arcuate ligament,
the psoas major,
the quadratus lumborum,
the transverse abdominal wall,
the psoas minor,
the internal oblique abdominal wall,
the iliacus, and
the psoas major.
According to an embodiment, a system for treating a patient with hypertension
is provided,
comprising a stimulation device comprising a first electrode arrangement
configured to deliver an
electric stimulation signal to a wall portion of a renal artery of the patient
to affect a vasomotor
tone of a smooth muscle tissue of the renal artery, a signal damping device
comprising a second
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electrode arrangement configured to deliver an electric damping signal to
tissue of the patient, and
a control unit operably connected to the stimulation device and to the signal
damping device. The
control unit is configured to control an operation of the stimulation device
such that the electric
stimulation signal causes vasodilation of the renal artery, and to control an
operation of the signal
damping device to damp or disturb the electric stimulation signal delivered by
the stimulation
device.
In an example, the second electrode arrangement is configured to deliver the
electric
damping signal to a nerve innervating the renal artery to damp or reduce
transmission of the
electric stimulation signal in the nerve.
In an example, the second electrode arrangement is configured to deliver the
electric
damping signal at a position between the first electrode arrangement and a
spinal cord of the
patient.
In an example, at least one of the first and second electrode arrangements
comprises a
plurality of electrode elements, each of which being configured to engage and
electrically stimulate
the wall portion of the renal artery or a nerve innervating the renal artery.
In an example, at least one of the first and second electrode arrangements is
arranged on a
surface portion of a support structure, and wherein the surface portion is
configured to be placed on
the wall portion of the renal artery or on a nerve innervating the renal
artery.
In an example, the support structure comprises a cuff configured to be
arranged at least
partly around the wall portion of the renal artery or the nerve innervating
the renal artery.
In an example, at least one of the first and second electrode arrangements is
arranged on an
inner surface of the cuff
In an example, each of the stimulation device and the signal damping device is
configured
to deliver an electric stimulation signal and an electric damping signal,
respectively, to a
parasympathetic nerve.
In an example, the control unit is configured to generate a pulsed electric
stimulation signal
for affecting the vasomotor tone of the smooth muscle tissue of the renal
artery.
In an example, the electric stimulation signal comprises a frequency of 30 Hz
or less, such
as 5-25 Hz, such as 10-20 Hz.
In an example, the electric stimulation signal comprises a pulse width of 0.01-
1 ms.
In an example, the electric stimulation signal comprises a pulse amplitude of
1-15 mA.
In an example, the control unit if configured to generate the electric damping
signal based
on the electric stimulation signal.
In an example, the electric damping signal is out of phase with the electric
stimulation
signal.
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In an example, the electric stimulation signal and the electric damping signal
are pulsed
signals, and wherein a frequency of the electric damping signal is higher than
a frequency of the
electric stimulation signal.
In an example, the frequency of the electric damping signal is at least twice
the frequency
of the electric stimulation signal.
In an example, the signal damping device is configured to deliver an electric
scrambling
signal for disturbing the electric stimulation signal passing the signal
damping device.
In an example, the system further comprises a signal processing means
configured to
measure the electric stimulation signal received at the signal damping device
and to generate the
1 0 electric damping signal based on the received electric stimulation
signal.
In an example, the control unit is configured to be communicatively connected
to a
wireless remote control.
In an example, the control unit comprises an internal signal transmitter
configured to
receive and transmit communication signals from/to an external signal
transmitter.
1 5 In an example, the system further comprises a source of energy for
energising the first
and/or second electrode arrangements.
In an example, the source of energy is configured to be implanted
subcutaneously.
In an example, the source of energy comprises at least one of a primary cell
and a
secondary cell.
20 In an example, the control unit is configured to indicate a functional
status of the source of
energy.
In an example, the functional status indicates a charge level of the source of
energy.
In an example, the control unit is configured to indicate a temperature of at
least one of the
source of energy, the nerve and tissue adjacent to the nerve.
25 In an example, the system according to any of the above embodiments may
further
comprise a coating arranged on at least one surface of at least one of the
stimulation device, the
damping device, and the control unit.
In an example, the coating comprises at least one layer of a biomaterial.
In an example, the biomaterial comprises at least one drug or substance with
antithrombotic
30 and/or antibacterial and/or antiplatelet characteristics.
In an example, the biomaterial is fibrin-based.
In an example, the system further comprises a second coating arranged on the
first coating.
In an example, the second coating is a different biomaterial than said first
coating.
In an example, the first coating comprises a layer of perfluorocarbon
chemically attached to
35 the surface, and wherein the second coating comprises a liquid
perfluorocarbon layer.
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In an example, the coating comprises a drug encapsulated in a porous material.
In an example, the surface comprises a metal.
In an example, the metal comprises at least one of titanium, cobalt, nickel,
copper, zinc,
zirconium, molybdenum, tin and lead.
In an example, the surface comprises a micropattern.
In an example, the micropattern is etched into the surface prior to insertion
into the body.
In an example, the system further comprises a layer of a biomaterial coated on
the
micropattern.
According to an embodiment, a system for treating a patient with hypertension
is provided,
comprising a stimulation device comprising an electrode arrangement configured
to deliver an
electric stimulation signal to a wall portion of a renal artery of the patent
to affect a vasomotor tone
of a smooth muscle tissue of the renal artery. The system further comprises an
implantable energy
receiver configured to energize the electrode arrangement, an energy source
configured to transfer
energy wirelessly to the energy receiver, and a control unit operably
connected to the stimulation
device. The control unit is configured to control an operation of the
stimulation device such that the
electric stimulation signal causes vasodilation of the renal artery.
In an example, the energy source is configured to be implanted in the patient.
In an example, the energy source is configured to be charged by energy
transferred
wirelessly from outside the body of the patient.
The system according to any of the preceding claims, wherein the control unit
is configured to
generate control instructions for controlling the operation of the stimulation
device, and to transmit
the control instructions wirelessly from outside of the body of the patient to
the stimulation device.
According to an embodiment, a system for treating a patient with hypertension
is provided,
comprising a stimulation device comprising an electrode arrangement configured
to deliver an
electric stimulation signal to a wall portion of a renal artery of the patent
to affect a vasomotor tone
of a smooth muscle tissue of the renal artery. The system further comprises a
source of energy
configured to energize the electrode arrangement, and a control unit operably
connected to the
stimulation device. The control unit is configured to generate control
instructions for controlling
the operation of the stimulation device such that the electric stimulation
signal causes vasodilation
of the renal artery and transmit the control instructions wirelessly to the
stimulation device.
In an example, the control unit comprises an external part configured to be
arranged
outside the body of the patient and an internal part configured to be
implanted in the patient, and
wherein the internal and external parts are configured to communicate
wirelessly with each other.
In an example, the internal and external parts are configured to communicate
with each
other by means of radiofrequency signals or inductive signals.
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According to an embodiment, a communication system for enabling communication
between a display device and a system according to any of the above
embodiments is provided.
The communication system comprises a display device, a server, and an external
device. The
display device comprises a wireless communication unit configured for
wirelessly receiving an
implant control interface from the server, the implant control interface being
provided by the
external device, the wireless communication unit further being configured for
wirelessly
transmitting implant control user input to the server, destined for the
external device. Further, the
display device comprises a display for displaying the received implant control
interface, and an
input device for receiving implant control input from the user. The server
comprises a wireless
communication unit configured for wirelessly receiving an implant control
interface from the
external device and wirelessly transmitting the implant control interface to
the display device, the
wireless communication unit further being configured for wirelessly receiving
implant control user
input from the display device and wirelessly transmitting the implant control
user input to the
external device. The external device comprises a wireless communication unit
configured for
wireless transmission of control commands to the system and configured for
wireless
communication with the server, and a computing unit. The computing unit is
configured for
running a control software for creating the control commands for the operation
of the system,
transmitting a control interface to the server, destined for the display
device,
receiving implant control user input generated at the display device, from the
server, and
transforming the user input into the control commands for wireless
transmission to the system.
According to an embodiment, a system for treating a patient with hypertension
is provided,
comprising a stimulation device comprising an electrode arrangement configured
to deliver an
electric stimulation signal to a wall portion of a renal artery of the patent
to affect a vasomotor tone
of a smooth muscle tissue of the renal artery, a source of energy configured
to energize the
electrode arrangement, a control unit operably connected to the stimulation
device, and an
elongated holding device. The elongated holding device is configured to be
attached to an outer
wall of the renal artery such that a length direction of the holding device
extends along a flow
direction of the renal artery. The holding device is further configured to
support the electrode
arrangement to allow the electrode arrangement to deliver the electric
stimulation signal to the wall
portion. The control unit is configured to control an operation of the
stimulation device such that
the electric stimulation signal causes vasodilation of the renal artery.
In an example, the electrode arrangement is attached to a surface portion of
the holding
device and configured to rest against the outer wall of the renal artery.
In an example, the system further comprises an attachment device configured to
fixate the
holding device to the renal artery.
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In an example, the attachment device comprises at least one of a suture
configured to be
sutured to the renal artery and a clamping device configured to at least
partly encircle the renal
artery.
In an example, the attachment device is configured to be attached to the
holding device and
5 a tissue portion external to the renal artery.
In an example, the holding device is flexible.
In an example, at least one of the source of energy and the control unit is
accommodated in
the holding device.
According to an embodiment, a system for treating a patient suffering from
hypertension is
1 0 provided. The system comprises a stimulation device comprising an
electrode arrangement
configured to deliver an electric stimulation signal to a wall portion of a
renal artery of the patient
to affect a vasomotor tone of a smooth muscle tissue of the renal artery, a
source of energy
configured to energize the electrode arrangement, a control unit operably
connected to the
stimulation device and configured to control an operation of the stimulation
device such that the
electric stimulation signal causes vasodilation of the renal artery, and a
holding device configured
to support the electrode arrangement at the outer wall of the renal artery to
allow the electrode
arrangement to deliver the electric stimulation signal to the wall portion.
The holding device is
configured to at least partly define a passage through which the renal artery
passes, and to allow a
width of the passage to follow changes in a width of the renal artery, such
that the width of the
passage increases with increased vasodilation and decreases with decreasing
vasodilation.
In an example, the holding device comprises a flexible portion configured to
rest against
the outer wall of the renal artery and to follow a motion of the outer wall as
the width of the renal
artery varies in response to the vasodilation.
In an example, the holding device comprises a cuff arranged to at least partly
encircle the
renal artery.
In an example, the cuff comprises at least one abutment element having a
varying volume
and configured to rest against the outer wall portion of the renal artery.
In an example, the abutment element comprises an inflatable element configured
to vary its
volume in response to the width of the renal artery varying with the
vasodilation.
In an example, the abutment element comprises a pneumatic or hydraulic element
having
an adjustable volume.
In an example, the system comprises a fluid reservoir, wherein the pneumatic
or hydraulic
element is fluidly connected to the fluid reservoir.
In an example, the system further comprises a pressure sensor device arranged
to sense
generate a signal indicative of a contact pressure between the holding device
and the outer wall of
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the renal artery, wherein the control unit is further configured to cause the
width of the passage of
the holding device to vary based on the signal from the pressure sensor.
In an example, the control unit is configured to operate the holding device to
maintain a
substantially constant contact pressure between the holding device and the
outer wall as the width
of the renal artery varies with the vasodilation.
In an example, the control unit is configured to control an operation of the
stimulation
device based on the signal generated by the sensor device.
According to an embodiment, a system for treating a patient with hypertension
is provided,
comprising a stimulation device having a heating member configured to be
implanted inside a renal
artery of the patient, an implantable source of energy configured to energize
the stimulation device,
and a control unit operably connected to the stimulation device. The control
unit is configured to
control an operation of the stimulation device such that heat is exchanged
between the heating
member and a wall portion of the renal artery to cause vasodilation of the
renal artery.
In an example, the source of energy is configured to be implanted inside the
renal artery or
integrated in the heating member.
In an example, the source of energy is configured to be charged by energy
transferred from
outside the renal artery, such as energy wirelessly transferred from outside
the renal artery.
In an example, the heating member is configured to be heated by energy
transferred from
outside the renal artery, for instance by means of a wired connection.
In an example, the heating member is configured to be inductively heated by
energy
transferred from outside the renal artery.
In an example, the heating member has a tubular shape having an outer surface
configured
to rest against an inner surface of the renal artery.
In an example, the heating member defines a passage through which a blood flow
of the
renal artery is allowed to pass, and wherein the heating member is configured
to follow change in a
width of the renal artery such that a width of the passage increases with
increased vasodilation and
decreases with decreasing vasodilation.
In an example, the heating member comprises a flexible portion configured to
allow the
heating member to follow the change in width of the renal artery.
In an example, the heating member comprises a shape memory material configured
to vary
the width of the passage in response to a varying temperature of the heating
member, thereby
allowing the heating member to follow the changes in the width of the renal
artery.
In an example, the heating member comprises a biocompatible material
configured to
promote fibrotic tissue growth thereon.
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In an example, the heating member is configured to be at least partly
encapsulated by
fibrotic tissue when implanted in the renal artery.
In an example, the heating member is configured to be secured to an inner
surface of the
renal artery.
In an example, the heating member is configured to be secured to the inner
surface by
means of sutures or staples.
According to an embodiment, a system for treating a patient with hypertension
is provided.
The system comprises a dilation device having an expansion member configured
to be implanted
inside a renal artery of the patient and to engage at least a portion of an
inner circumferential
surface of the renal artery, wherein the expansion member expandable to
increase a width of the
renal artery. The system further comprises an implantable source of energy
configured to energize
the dilation device, and a control unit operably connected to the dilation
device. The control unit is
configured to control an operation of the dilation device to induce
vasodilation of the renal artery.
In an example, the source of energy is configured to be implanted inside the
renal artery,
such as being integrated in the expansion member.
In an example, the source of energy is configured to be charged by energy
transferred from
outside the renal artery, such as wirelessly transferred from outside the
renal artery.
In an example, the expansion member is configured to be powered by energy
transferred
from outside the renal artery, for instance by means of a wired connection or
inductively powered
by energy transferred from outside the renal artery.
In an example, the expansion member is configured to be operated by means of
mechanic,
hydraulic or thermal action.
In an example, the system further comprises an operation device configured to
control the
operation of the expansion member. The operation device may comprise a
hydraulic reservoir in
fluid connection with the expansion member.
In an example, the expansion member comprises a shape memory material
configured to
vary a shape of the expansion member in response to a varying temperature of
the expansion
member.
In an example, the expansion member has a tubular shape having an outer
surface
configured to rest against an inner surface of the renal artery.
In an example, the expansion member defines a passage through which a blood
flow of the
renal artery is allowed to pass, and wherein the expansion member is
configured to cause
vasodilation by increasing a width of the passage.
In an example, the expansion member comprises a biocompatible material
configured to
promote fibrotic tissue growth thereon.
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In an example, the expansion member is configured to be at least partly
encapsulated by
fibrotic tissue when implanted in the renal artery.
In an example, the expansion member is configured to be secured to an inner
surface of the
renal artery.
In an example, the expansion member is configured to be secured to the inner
surface by
means of sutures or staples.
Any embodiment, part of embodiment, example, method or part of method may be
combined in any applicable way within the terms of the appended claims.
1 0 Brief description of drawings
The inventive concept is now described, by way of example, with reference to
the accompanying
drawings, in which:
Figures la-b show an example of the kidneys of a human patient, and the blood
vessels
supplying the kidneys with blood.
Figure 2 shows an example of the innervation of the renal arteries leading to
the kidneys.
Figures 3a-b shows the mechanisms of vasoconstriction and vasodilation in a
blood vessel.
Figures 4-8 show various examples of medical devices implanted to electrically
or
otherwise induce vasodilation in the renal artery.
Figures 9a-d show various examples of electrodes.
Figures 10a-c are diagrams illustrating signal damping signals as applied in
the context of
the present inventive concept.
Figure 11 is a schematic outline of a system for affecting the blood pressure
in a patient.
Figures 12a-d and 13a-b are various examples of sensors.
Figure 14 illustrate an electrical stimulation device and a sensor implanted
at the rental
artery.
Figures 15 and 16 show diagrams illustrating electric stimulation signals.
Figures 17a-c, 18 and 19a-d illustrate the mechanisms behind formation of
fibrin.
Figures 20-22 and 23a-b illustrate various example of coatings.
Figures 24a-f and 25a-h illustrate systems according to some examples of the
present
inventive concept.
Figure 26 illustrate a remote unit when implanted in the body of a patient.
Figures 27, 28, and 29a-c illustrate a remote unit according to some examples.
Figures 30a-b, 3 la-b and 32a-b show various examples of a connection portion
of a remote
unit.
Figure 33 illustrate a kit for assembling an implantable medical device.
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Figures 34-37 show implantable remote units according to some examples.
Figures 38a-b show cross sections of a remote unit according to an example.
Figures 39a-d show various examples of orientation of a first unit relative to
a second unit
of the remote unit.
Figures 40 and 41 show a remote unit when implanted.
Figures 42 and 43 show examples of different dimensions of the remote unit.
Figures 44a-c show a procedure of inserting a remote unit in a tissue portion.
Figure 45 shows an example of a remote unit comprising at least one coil.
Detailed description
In the following, a detailed description of embodiments of the invention will
be given with
reference to the accompanying drawings. It will be appreciated that the
drawings are for illustration
only and are not in any way restricting the scope of the invention as defined
by the appended
claims. Thus, any references to directions, such as "up" or "down", are only
referring to the
directions shown in the figures. It should be noted that the features having
the same reference
numerals generally may have the same function. A feature in one embodiment
could thus be
exchanged for a feature from another embodiment having the same reference
numeral, unless
clearly contradictory. The description of the features having the same
reference numerals should
thus be seen as complementing each other in describing the fundamental idea of
the feature and
thereby showing the versatility of the feature.
Vasodilation of a blood vessel, or dilation of the blood flow passageway of
the blood
vessel, is to be understood as an operation increasing a cross-sectional area
of the inside space of
the vessel. The renal artery is an example of a blood vessel, or luminary
organ which can be filled
with, and/or convey a flow of, a bodily fluid such as blood.
In the context of the present application, the tern) "renal artery" may be
understood as any
blood vessel providing a (main) supply of blood to a kidney. In case of a
transplanted or artificial
kidney, which often is placed in a location different from the original
kidney, such as the iliac
fossa, the renal artery may be connected to the external iliac artery. The
present inventive concept
may thus be applied also to such a blood vessel.
A control unit or controller is to be understood as any implantable unit
capable of
controlling the operation of an electrically operated device, such as a
stimulation device or a signal
damping device. A controller could include an electrical power source or
another operation device
for operating the stimulation device and the signal damping device. A control
unit may also be
understood as an element comprising circuitry configured to carry out various
functions, such as
data storage and processing, and signal generation. The control unit may be
configured to transmit
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the control instructions to the stimulation device over a wired channel or a
wireless channel.
Further, the control unit may comprise an external part configured to be
arranged outside the body
of the patient and an internal part configured to be implanted in the patient.
The internal and
external parts may be configured to communicate wirelessly with each other,
for example by means
5 of radiofrequency signals or inductive signals.
A control signal is to be understood as any signal capable of carrying
information and/or
electric power such that for instance the stimulation device can be directly
or indirectly controlled.
An implantable operation device, sometimes also referred to as a controller,
may further be
understood as any device or system capable of operating an active implant. An
operation device or
10 controller could for example be an actuator such as a hydraulic actuator
including for instance a
hydraulic pump or a hydraulic cylinder, or a mechanical actuator, such as a
mechanical element
actuating an implant by pressing or pulling directly or indirectly on the
implant, or an
electromechanical actuator such as an electrical motor or solenoid directly or
indirectly pressing or
pulling on the implant. The operation device may comprise a control unit as
described above,
15 and/or circuitry configured to carry out such functions.
Blood pressure is generally referred to as the pressure of circulating blood
against the walls
of blood vessels. Most of this pressure results from the heart pumping blood
through the circulatory
system. In common language, the term 'blood pressure' often refers to the
pressure in the larger
arteries. Blood pressure is usually expressed in terms of the systolic
pressure (maximum pressure
during one heartbeat) over diastolic pressure (minimum pressure between two
heartbeats). Blood
pressure can be understood as being influenced by cardiac output, systemic
vascular resistance and
arterial stiffness and may vary depending on situation, emotional state,
activity, and relative
health/disease states.
Blood pressure that is too low is called hypotension, pressure that is
consistently too high is
called hypertension, and normal pressure is called normotension. Long-term
hypertension is a risk
factor for many diseases, including stroke, heart disease and kidney failure.
The Task force for the
management of arterial hypertension of the European Society of Cardiology
(ESC) and the
European Society of Hypertension (ESH) has provided the following definitions
of hypertension:
Category Systolic BP, mmHg Diastolic BP, mmHg
Optimal <120 <80
Normal 120-129 80-84
High normal 130-139 85-89
Grade 1 hypertension 140-159 90-99
Grade 2 hypertension 160-179 100-109
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Grade 3 hypertension > 180 > 110
The risk of cardiovascular disease is considered to increase progressively
above 115/75 mmHg.
Below this level there is limited evidence.
Vascular resistance is the resistance that must be overcome to push blood
through the
circulatory system and create flow. The resistance offered by the systemic
circulation is known as
the systemic vascular resistance (SVR). Vasoconstriction (i.e., decrease in
inner blood vessel
diameter) increases the SVR, whereas vasodilation (increase in inner diameter)
decreases the SVR.
Many mechanisms have been proposed to account for the rise in SVR in
hypertension.
Most evidence implicates either disturbances in the kidneys' salt and water
handling (particularly
abnormalities in the intrarenal renin¨angiotensin system, RAS) or
abnormalities of the sympathetic
nervous system. The mechanisms are not mutually exclusive, and it is likely
that both contribute to
some extent in hypertension. Excessive sodium or insufficient potassium in the
diet may lead to
excessive intracellular sodium, which may contract vascular smooth muscle
tissue, restricting
blood flow and so increases the blood pressure.
The renin¨angiotensin system, RAS, is a hormone system that has been found to
regulate
blood pressure as well as systemic vascular resistance. When renal blood flow
is reduced, which
may be the case in for instance hemorrhage or dehydration, juxtaglomerular
cells in the kidneys
convert the precursor prorenin (already present in the blood) into renin and
secrete it directly into
circulation. This starts a chain reaction that eventually results in the
release of angiotensin II, which
has shown to be a potent vasoconstrictive peptide that may cause blood vessels
to narrow and the
blood pressure to increase accordingly. Angiotensin II is also known to be
involved in an increase
of extracellular fluid in the body, which also increases blood pressure.
The present invention is based on the realization that by causing an
electrically induced
vasodilation of the renal artery, a reaction that causes a reduction of the
systemic vascular
resistance may be triggered. The electrically induced vasodilation of the
renal artery may be
achieved by means of a stimulation device, which may be arranged to stimulate
a nerve innervating
the renal artery and/or to provide a direct or indirect stimulation of the
smooth muscle tissue of the
renal artery.
The stimulation device may be adapted to alter the vasomotor tone of the
smooth muscle
cells of the renal artery, causing the cells to relax. Sympathetic stimulation
(norepinephrine) has
been observed to constrict some blood vessels and dilate others, depending on
whether the target
cells (i.e., the smooth muscle cells) has alpha- or beta-adrenergic receptors.
The sympathetic
nervous system can also constrict or dilate vessels just by changing firing
frequency. An increased
firing frequency may cause the smooth muscle to contract and constrict the
vessel, whereas a
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reduced firing frequency may cause the smooth muscle cells to relax, allowing
blood pressure to
dilate the vessel.
The inventor has realized that the electric stimulation device may be employed
to affect the
vasomotor tone of the smooth muscle cells to cause the lumen to relax, with
the aim of triggering a
reduction of the systemic vascular resistance. The electric stimulation device
may thus form part of
a system for treating a patient with hypertension.
While the focus of the present application may be laid on inducing
vasodilation to trigger a
bodily reaction to reduce the systemic blood pressure, it will be appreciated
that the inventive
concept of utilizing electrical stimulation for affecting the vasomotor tone
of the renal artery may
as well be employed for triggering a response increasing the systemic blood
pressure. The present
inventive concept may hence be applied also for treating patient suffering
from hypotension. The
aspects, embodiments and examples herein may be combined with implementations
wherein
electrically induced vasoconstriction is generated by electrical stimulation.
The vasoconstriction
may be achieved by controlling the electrical stimulation signal such that a
contraction of the renal
artery is achieved.
The inventor has further realized that a control, or regulation, of the
electrically induced
vasodilation may be achieved by providing a sensor, or sensor device, capable
of generating a
signal indicative of a blood pressure of the patient. The output signal from
the sensor may then be
supplied to a control unit, which is configured to control an operation of the
stimulation device
based on the signal generated by the sensor. The control unit may in some
examples utilize the
signal from the sensor as a trigger signal, indicating that the stimulation
may be initiated and/or
ceased. In further examples, the control unit may utilize the signal from the
sensor as a feedback
control signal, preferably driving the system (and hence the vasodilation or
even systemic blood
pressure) to a desired state (such as normotension. Exemplary embodiments,
effects and advantages
of using such an optional sensor is described in further detail in connection
with figures 12 to 14.
Furthermore, the electrical stimulation signal used for causing the renal
artery to relax may
inadvertently progress towards the aorta and/or the spinal cord, thereby
risking causing unwanted
side effects and unpleasant experiences for the patient. Therefore, a signal
damping device may
according to some implementations of the inventive concept be provided to
mitigate the effects of
the electrical stimulation signal by damping, disturbing or at least partly
cancelling the electrical
stimulation signal, thereby limiting the spreading of the electrical
stimulation signal to other parts
of the patient's body. Exemplary embodiments of signal damping approaches is
discussed below
with reference to figures 6-8, 10 and 11.
As an introduction to the field in which the present inventive concept can be
applied, an
exemplary description of the neurophysiology of the renal artery will be
described in the following.
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It is to be noted that the following description of the neurophysiologic
mechanisms affecting
vasoconstriction of the renal artery is exemplary, simplified where needed,
and based on the
present knowledge in the art. The purpose of the following exemplary
description of the bodily
functions and responses is primarily not to limit or define the inventive
concept, but to give an
exemplary technical/physiological background and context of the inventive
concept.
Figures la and b are schematic illustrations of the kidneys of an adult, human
patient. It is
common for a normal human to have two kidneys 10, each of which being
connected to the
circulatory system by means of a renal artery 20 that carries blood from the
heart to the kidneys 10
via the aorta 22 and renal vein 30 that drains the kidney 10 and connects it
to the inferior vena cava
32.
Figure 2 shows the kidneys 10 and the main renal arteries (MRA) 20, which are
identified
as the renal main blood supply arteries arising from the aorta 22 and ending
at its bifurcation split.
Although the illustrations in the present application show a single renal
artery 20 connecting a
respective kidney 10, the inventive concept is equally applicable to patients
wherein a kidney is
supplied by multiple renal arteries, which may have a separate origin in the
aorta 22. In case of
multiple renal arteries, the electrical stimulation may be delivered to at
least one of the renal
arteries, such as the vessel with the greatest diameter (this may consequently
be referred to as the
MRA).
Renal nerves 24 may be identified as fiber structures originating from ganglia
in the solar
plexus or from the splanchnic nerve collection, forming the renal plexus. The
renal nerve plexus
may thus be understood as the network of nerve fibers 24 innervating the renal
artery 20 as well as
the kidney 10. It appears as a major part of the nerves are sympathetic
nerves, but the renal plexus
may according to some findings also comprise parasympathetic nerves.
Beneficially, the
stimulation device may be arranged to deliver the electric stimulation to a
parasympathetic nerve at
least in a branch of a spinal cord dispatching number 10 and along the
Coccygeal nerves
originating at vertebrae S2-S4, preferably S4.
Figures 3a and b illustrate the concept of vasoconstriction and vasodilation.
The open cross
section of the lumen formed by the blood vessel, such as the renal artery 20
showed in figures 3a
and b, may be determined by the vasomotor tone of the smooth muscle cells. The
smooth muscle
cells of the wall of the renal artery 20 may be innervated by nerve fibers 24,
such as for instance
sympathetic nerve fibers 24. Sympathetic stimulation has been observed to
constrict some blood
vessels and dilate others, depending on whether the smooth muscle cells have
alpha- or beta-
adrenergic receptors. As mentioned above, the sympathetic nervous system can
also constrict or
dilate vessels just by changing frequency of the action potentials of the
nerve fibers 24. In the
present figures, an example is illustrated in which an increased action
potential frequency
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(indicated by pulses 26) may cause the smooth muscle tissue to contract,
leading to
vasoconstriction as illustrated in figure 3a. Reducing the action potential
frequency 26 may cause
the smooth muscle tissue to relax, leading to vasodilation as illustrated in
figure 3b. The
stimulation device according to the present inventive concept may be employed
to modify the
action potential frequency to cause a relaxation of the smooth muscle tissue.
Put differently, the
stimulation device may be operated to change the vasomotor tone of the smooth
muscle tissue of
the vessel. The electrical stimulation may be delivered directly to the outer
wall of the renal artery
20, or to the nerve fibers 24 innervating the wall of the renal artery 20.
Figure 4 shows a renal artery 20 connecting a kidney 10 to the aorta 22, and
which may be
similar to the renal arteries 20 disclosed in figures 1-3. In order to treat
hypertension, a stimulation
device 110 may be implanted in the patient. The stimulation device 110 may
comprise an electrode
arrangement, such as a first electrode arrangement 112, configured to deliver
an electric stimulation
signal to tissue of the patient, thereby causing tissue of a wall portion of
the renal artery 20 to relax
and dilate a blood flow passageway of the renal artery 20. In the present
example, the first
electrode arrangement 112 is configured to be attached to the outer wall of
the renal artery 20 to
deliver an electric stimulation signal to the smooth muscle tissue of the
renal artery wall 22. In this
way, the smooth muscle tissue may be subject to an electrical stimulation that
causes vasodilation.
The first electrode arrangement 112 may for example comprise a plurality of
electrical
electrodes 112a, 112b, each of which having a contacting portion, or electrode
element 112a,
configured to be arranged to engage the wall of the renal artery 20, and a
lead portion 112b
electrically connecting the contacting portion 112a to a control unit 114 of
the stimulation device
110. The contacting portion 112a of the first electrode arrangement 112 may
for example be
attached to the wall of the renal artery 20 by means of stitches, for instance
allowing for the
contacting portion 112a to be at least partly inserted into the tissue on the
outer surface of the wall.
In further examples, the contacting portion 112a may be arranged on a surface
portion, such as a
patch (not shown), which in turn may be placed on the tissue of the wall of
the renal artery 20.
The control unit 114 may be configured to be electrically connected to the
electrode
arrangement 112 to provide the contacting portions 112a with the electric
stimulation signal. The
control unit 114 may thus in turn be operatively connected to, or comprise, a
power source
energizing the control unit 144 and the electrode arrangement 112. Further,
the device may
according to some embodiments comprise an additional control unit, also
referred to as a central
control unit, which may be implanted in the body or be a remote unit, arranged
outside the body.
Further, the control unit 114 may in some examples be configured to transmit
control instructions
wirelessly to the stimulation device.
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The number of contact points, in which the electric stimulation signal can be
delivered to
the smooth muscle tissue, may be selected based on the desired response and
the characteristics of
the stimulation signal used. Increasing the number of contact points may for
example allow for a
lower signal amplitude required to generate the desired response (i.e., a
relaxation) of the muscle
5 tissue. Conversely, an increase signal amplitude may be used for allowing
a reduce in number of
contact points. Further, it will be appreciated that some or all of the
contacting portions 112a may
be individually controlled with respect to the stimulation signal, such that
the stimulation signal can
be selectively and controllable delivered to one or several of the contact
points at the time. The
selective application at different contact points may for example be enabled
by the control unit 114.
10 When a reduction in systemic vascular resistance is desired, the
stimulation device 110
may be operated to generate an electrical stimulation signal that is
transmitted from the control unit
114 through the leads 112b to the contacting portions, or electrode elements
112b, which deliver
the electrical stimulation signal to the muscle tissue of the wall of the
renal artery 20. The electrical
stimulation signal may be configured, with respect to e.g. voltage, current or
frequency, to trigger a
15 vasodilation response in the renal artery. The vasodilation may in turn
result in a systemic response
as described above.
Figures 5a-h show a renal artery 20 which may be similar to the renal arteries
disclosed in
the previous figures. Figure 5a-d further disclose a stimulation device which
may be similarly
configured as the one disclosed in connection with figure 4, and may thus
comprise an electrode
20 arrangement 112a, 112b configured to deliver an electric stimulation
signal for affecting vasomotor
tone in the renal artery 20. The stimulation device may comprise a plurality
of contacting portions
112a, or electrode elements 112a, configured to mechanically engage, or be
arranged to rest
against, tissue of an outer wall of a portion of the renal artery 20 to
transmit the electrical
stimulation signal to the tissue. In the example in figure 5a, the electrode
elements 112a are
arranged on an inner surface of a cuff portion 116 configured to be arranged
at least partly around
the renal artery 20. The cuff portion 116 may in turn be electrically
connected to the control unit
114 of the stimulation device 110 by means of a lead 112b. Further
configurations are disclosed in
figures 5b-d, in which the electrode elements 112a are supported by an
elongated holder 116
arranged to keep the electrode elements 112a in the desired position at the
wall of the renal artery
20. The holder 116, also referred to as a holding device 116, is formed as an
elongated device
configured to be attached on the outer wall of the renal artery such that a
length direction L of the
holder 116 extends along a flow direction of the artery 20. Further, an
attachment device may be
provided to assist in fixating the holder 116 to the renal artery 20. The
attachment device may for
instance be formed of at least a part of the electrode element 112a, as shown
in figure 5c, which
may be arranged to at least partly encircle the renal artery 20 and thereby
act as a clamp for fixating
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the holder 116 to the artery 20. Alternatively, or additionally, the
attachment device may comprise
a suture (not shown) configured to be sutured to the artery to assist in
fixating the holder 116. In
further examples, such as the configuration shown in figure 5d, the attachment
device is configured
to be attached to a tissue portion external to the renal artery 20. This may
be realized by a
supporting rod 116' or lever adapted to extend from the holder 116 and to be
attached to tissue
surrounding the renal artery 20 or the kidney 10 by means of, for instance,
sutures or staples.
Beneficially, the supporting rod 116' may eventually be embedded or
encapsulated by fibrotic
tissue assisting keeping the holder 116 and the electrode arrangement 112a in
the correct position.
It will be appreciated that the holder 116 may be flexible to allow some
movement of the
stimulation device 110 when implanted. The movement may for instance be caused
by the patient
moving, or by vasodilation of the artery 20. Further, at least one of a source
of energy and control
unit of the system may be accommodated in the holder 116.
In the above, vasodilation induced by electrical stimulation of nerves have
been discussed.
Alternative or additional mechanisms for causing the renal artery to expand or
contract are however
possible, and can beneficially be combined with the inventive concept
disclosed in the present
application. Two examples of such mechanisms will now be discussed with
reference to figures 5e-
i, namely thermally induced vasodilation and mechanically induced
vasodilation.
Figure 5e shows a portion of the renal artery 20 in figures 5a-d, in which a
stimulation
device 110 having a plurality of heating members 117 have been implanted. In
this embodiment,
the control unit 114, 124 is configured to control an operation of the
stimulation device such that
heat is exchanged between the heating members 117 and the wall portion of the
renal artery 20 to
cause vasodilation thereof. The heat energy may be provided from a source of
energy that is
implanted inside the renal artery 20, for example integrated in the heating
member, or transferred
from outside the renal artery 20. In the latter case, the energy may be
transferred by means of a
.. wired connection or wirelessly, such as inductively.
While the present figure shows heating members 117 shaped as electrodes
attached to the
interior of the artery, it will be appreciated that they may as well have a
tubular shape with an outer
surface configured or rest against the inner surface of the artery, or be
attached to such a tubular
structure to facilitate insertion and possibly attachment in the vessel. An
example of such a
configuration is disclosed in figure 5f, in which a first and a second
catheter 118 are inserted into
the artery 20 through the arterial wall and arranged such that the heating
members 117 are in
thermal contact with the interior side of the artery 20.
In yet a further example, the heating member 117 may define a passage through
which a
blood flow of the renal artery 20 is allowed to pass. The heating member 117
may thus have a
.. shape conforming to a stent abutting the inner surface of the artery.
Beneficially, the heating
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member 117 may comprise a flexible or expandable portion configured to allow
the heating
member 117 to follow the change in width of the artery 20 such that a width of
the passage
increases with increased vasodilation and decreases with decreasing
vasodilation. The heating
member 117 may comprise a shape memory material configured to vary the width
of the passage in
response to a varying temperature of the heating member. Further, the heating
member may
comprise a biocompatible material configured to promote fibrotic tissue to
promote fibrotic tissue
growth thereon ¨ especially on portions arranged outside the artery, such as
the external portion of
the catheter 118 shown in figure 5f. Preferably, the heating member may be
configured to be
secured to an inner surface of the artery, where it may be at least partly
encapsulated by fibrotic
tissue when implanted. Alternatively, or additionally the heating member may
be secured to the
inner surface by means of sutures or staples.
It will be appreciated that the heating member 117 in some examples may have a
cooling
capacity allowing it to cool the wall of the renal artery 20 to cause the
artery to contract. The
heating member 117 may thus also be referred to as a thermal member, having
the capacity to
transfer heat to the wall and/or transfer heat from the wall. The operating
mechanism of the thermal
member may be based on a resistive heating, or the Peltier effect. In further
examples, the heat may
be transferred by means of a carrier fluid, such as water, arranged to add or
remove heat from the
wall of the artery 20.
During operation, the control unit 114, 124 may operate the stimulation device
110 such
that the thermal member 117 is heated, thereby heating the renal artery 20
locally at position of the
thermal member 117. As a result, a dilation of the blood vessel 20 may be
achieved, allowing the
blood to flow more freely within the renal artery 20 and thereby increase the
blood pressure in the
kidney 10.
Mechanically induced vasodilation will now be discussed with reference to
figures 5g-h, in
which the renal artery 20 may be expanded by means of dilation device having
an expansion
member 212 implanted inside the artery. The expansion member 212 is configured
to engage at
least a portion of a in inner circumferential surface of the renal artery 20
and exert and expanding
pressure on the wall of the renal artery 20 to assist in the vasodilation.
Thus, the expansion member
212 may be used instead of the thermal or electrical stimulation devices
discussed above, or in
combination with either of them. Similar to the previous stimulation devices,
the operation of the
dilation device may be controlled by the control unit 112, 124 and energized
by a source of energy
similarly configured as the previously discussed sources of energy. Thus, the
source of energy may
be configured to be implanted inside the renal artery, be integrated in the
expansion member, or
arranged outside the renal artery. In the latter case the energy may be
transferred wirelessly, such as
inductively, or by means of a wired connection. Further, the source of energy
may be charged by
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energy wirelessly transferred from outside the renal artery, such as from an
extraluminar source of
energy which may be implanted elsewhere in the body or arranged outside the
body of the patient.
The expansion member 212 may be understood as a device suitable for
implantation inside
the artery and possible to controllably expand and/or contract so as to cause
vasodilation. The
expansion may for example be caused by means of mechanic, hydraulic or thermal
action as will be
discussed in the following. Further, the expansion member may comprise a
tubular shape having an
outer surface configured to rest against the inner surface of the renal artery
20. The expansion
member 212 may for instance define a passage through which a blood flow of the
renal artery 20 is
allowed to pass. The expansion member 212 may be secured at its position by
means of sutures or
staples, and/or by means of fibrotic tissue at least partly covering or
encapsulating the expansion
member 212. Preferably, the expansion member 212 comprises a biocompatible
material promoting
fibrotic tissue growth.
In the example shown in figure 5g the expansion member may be a tubular
structure, such
as a stent-like structure, configured to be fitted within the inner walls of
the artery 20. The tubular
structure may be formed by a net-like structure, and preferably by a shape-
memory materials that
varies its shape with the temperature. This allows for the passageway defined
by the expansion
member to vary its cross-sectional area with the temperature, such that a
heating of the tubular
structure may cause the structure to expand and thereby induce vasodilation in
the renal artery 20.
Correspondingly, a cooling of the tubular structure may result in the
structure contracting, reducing
the pressure on the arterial wall and allowing it to contract again.
The heating may for instance be achieved by resistive heating of the shape-
memory
material, either directly or indirectly, or by means of additional heating
elements (such as the ones
disclosed in connection with figures 5e-d).
An alternative principle of operation of the expansion member 212 is shown in
figures 5h-i,
in which the expansion member 212 comprises at least one hydraulic expansion
means, or bellows
214, operable to cause the expansion member 212 to increase its circumference.
In the present
example, the expansion member 212 is cylindrical or at least ring-shaped and
comprises a first and
a second abutment element 213 configured to be arranged to rest against the
inner surface of the
artery 20. The abutment elements 213 are interconnected by a first and a
second bellows 214,
which are hydraulically operated via a hydraulic reservoir (not shown) to
cause the first and second
abutment elements 213 to expand the arterial wall. The hydraulic reservoir may
be implanted at a
location different from the renal artery, and a motor or pump may be employed
to move hydraulic
fluid between the bellows and the reservoir to control the expansion and
contraction. The motor or
pump may be controlled by the control unit 114, 124 as discussed above.
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Other operation principles are also possible, such as a mechanical expansion
means instead
of the bellows 214. A threaded, rotating bolt is an example of such a
mechanical expansion means,
wherein the bolt may be moved into and out from a nut to cause the expansion
member 212 to
increase or reduce its width.
Figure Si illustrates the hydraulic expansion member 212 in figure 5h when
implanted in
the renal artery 20, whereas figure Si shows the stent-like expansion member
212 in figure 5g when
implanted.
Figure 6 shows a similar renal artery 20 as in figures 5a-j, in which a signal
damping
device 120 has been implanted to at least partly enclose a portion of the
renal artery 20. The signal
damping device 120 may comprise a second electrode arrangement 122a, 122b
configured to
deliver an electric signal for damping or disturbing the electrical
stimulation signal generated by
the stimulation device 110, which may be similar to the ones disclosed in
figures 4 and S.
Alternatively, the signal damping device 120 is configured to divert the
electrical stimulation
signal, for instance by connecting a portion of the renal artery to ground or
at least to a lower
electrical potential, allowing the electric stimulation signal to travel
towards the reduced potential
rather than towards the spinal cord of the patient. The damping device 120 may
be provided and
operated with the purpose of reducing the effect of the electric stimulation
signal on parts of the
body other than the renal artery 20.
The utilization of the signal damping device 120 relies on the insight that
the electrical
stimulation signal used for causing the renal artery 20 to relax inadvertently
may progress towards
the spinal aorta 22 and/or the spinal cord, thereby risking causing unwanted
side effects and
unpleasant experiences for the patient. The signal damping device 120 may
hence be provided to
mitigate the effects of the electrical stimulation signal by damping,
disturbing or at least partly
cancelling the electrical stimulation signal on its way away from the renal
artery 20 and the kidney
10. The signal damping device 120 may hence be arrange to at least partly
intercept the electrical
stimulation signal during its progress through the tissue towards the aorta
22/spinal cord. These
mechanisms are discussed in greater details below, for instance in connection
with figures 10a-c.
The functionality of the medical device 110 generating the electric
stimulation signal, i.e.,
the control unit 124 and the electrode arrangement 112a, 112b may also be
referred to as a
stimulation device 110. The stimulation device 110 and the signal damping
device 120 may hence
be operated at the same time, or simultaneously, to treat hypertension. The
stimulation device 110
may be operated to deliver the stimulation signal and cause vasodilation,
while the signal damping
device 120 is operated to damp or disturb the stimulation signal propagating
towards tissue for
which electrical stimulation is unwanted.
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The signal damping device 120 may be arranged to engage tissue of the renal
artery 20, or
a nerve innervating the renal artery 20, at a position allowing the
stimulation device 110 to be
arranged between the kidney 10 and the signal damping device 120. By this
placement, the signal
damping device 120 may be employed to prevent or at least partly hinder the
electrical stimulation
5 .. signal from propagating 'upstream' the nerve or renal artery 20, that is,
towards the spinal cord or
aorta.
In the present example, the stimulation device 110 may comprise a first
electrode
arrangement 112 comprising a plurality of electrode elements 112a configured
to engage the wall
of the renal artery 20. The electrode elements 112a may be connected to a
control unit 114 by
10 means of electrical lead portions 112b and configured to deliver an
electric stimulation signal
generated by the control unit 114. The contacting portions 112a may for
example be attached to the
wall of the renal artery 20 by means of stitches, for instance allowing for
the contacting portion
112a to be at least partly inserted into the tissue on the outer surface of
the wall, or arranged on a
surface portion, such as a patch (not shown), which in turn may be placed on
the tissue of the wall
15 of the renal artery 20.
The signal damping device 120 may comprise a plurality of contacting portions
122a, or
electrode elements 122a, configured to mechanically engage, or be arranged to
rest against, a
portion of the renal artery 20 to transmit the electrical stimulation signal
to the tissue. In the present
example, the electrode elements 122a are arranged on an inner surface of a
cuff portion 126
20 configured to be arranged at least partly around the renal artery 20.
The cuff portion 126 may in
turn be electrically connected to the control unit 124 of the stimulation
device 110 by means of a
lead 122b.
During operation, when a reduction of blood pressure, or systemic vascular
resistance, is
desired, the signal damping device 120 may be caused to deliver an electrical
damping signal
25 preventing or at reducing propagation of the stimulation signal
delivered to the renal artery 20. The
electrical damping device 120 may for instance be configured to counteract or
damping the action
potentials that may be generated by the stimulation signal, thereby reducing
the reaction from
muscle cells or nerve cells in the vicinity of the electrode elements 122a of
the signal damping
device 120. Additionally, or alternatively, the electrical damping device 120
may be configured to
deliver an electrical damping signal which is configured to cancel or damp the
electrical
stimulation signal by means of amplitude cancellation or by scrambling the
signal (e.g., in terms of
frequency contents) into a signature which cannot be 'read' by the muscle
tissue or the nervous
tissue. In different words, the electrical stimulation signal may be modified
in a way that reduces its
effect on tissue. Combinations are conceivable: the signal damping device 120
may be arranged to
counteract or damp the action potentials affecting tissue such as smooth
muscle cells and nerve
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cells and to damp or disturb the electrical stimulation signal before it
propagates past the electrode
elements 122b of the signal damping device 120.
Figures 7a-b are cross sections of devices for delivering an electric signal
to tissue of the
patient. The devices may for example be a stimulation device 110 or a signal
damping device 120,
.. similarly configured as any of the embodiments described above with
reference to figures 4-6. In
the following description of figure 7a the device will be exemplified as a
signal damping device
120. However, it will be appreciated that the description may equally well
apply to a stimulation
device 110.
In the present example, the signal damping device 120 may comprise a support
structure
126, such as for example a cuff 126, which may be formed to two or more
support elements that
are hingedly connected to each other and movable to allow the support
structure 126 to be arranged
around the renal artery 20. The support structure 126 may thus be arranged to
at least partly, or
completely, surround the renal artery 20, such that an inner surface portion
of the support structure
126 faces or abuts an outer wall surface of the renal artery 20 when
implanted. The support
structure 126 may for instance be positioned by the surgeon attaching two or
more interconnecting
support elements to each other, when the support structure 126 is positioned
around the renal artery
20. The inner circumference of the support structure 126 may be adapted to fit
snuggly around the
renal artery 20, and may either be adjustable, for instance by varying an
overlap of the elements
forming the support structure 126 upon attachment to the renal artery 20, or
by selecting a support
structure 126 (out of a plurality of different support structures) having a
suitable circumference.
The inner surface may be adapted to support one or several electrode elements,
or
contacting portions 122a, for delivering an electrical damping signal to the
tissue of the renal artery
20, or for connecting the tissue of the renal artery 20 to a lower electrical
potential, such as ground,
to divert the electrical stimulation signal from the tissue to the lower
electrical potential. In this
way, the signal damping device 120 may be capable of preventing the electrical
stimulation signal
from propagating past the signal damping device 120, or at least of reducing
the impact of the
electrical stimulation signal otherwise may have on tissue in the vicinity of,
or upstream, the signal
damping device 120. The electrode elements 122a may be electrically connected
to a ground
potential, or at least to a lower electric potential, by means of electrical
leads 122b. Alternatively,
.. the electric leads 122b connect the electrode elements 122a to a control
unit 124 configured to
generate a signal for damping or disturbing the electric stimulation signal,
as described above.
The electrode elements 122a may preferably be arranged at the interface or
contact surface
between the support structure 126 and the tissue. The electrode elements 122a
may for instance be
plate electrodes, comprising a plate-shaped part forming contact with the
tissue (as already stated,
this applies both to signal damping devices as well as stimulation devices).
In other examples, the
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electrode elements 122a may be a wire electrode or a lead, formed of a
conducting wire that can be
attached to the inner surface of the support structure 126 and brought in
electrical contact with the
tissue. Further examples may include needle- or pin-shaped electrodes, having
a point at the end
which can protrude from the inner surface of the support structure 126 and be
inserted in the tissue
of the wall, at which the signal damping device 120 or stimulation device 110
may be arranged to
rest.
The control unit 124 may be operably connected to the electrode elements 122a
for
controlling the electric damping (or stimulation) signal provided to the
tissue of the renal artery
20.The control unit 124 may be structurally integrated in the stimulation
device shown in for
example figure 6 and may be configured to receive input from a sensor arranged
to sense or
measure the electric stimulation signal generated by the stimulation device
110. In some examples,
the sensor may be integrated with the control unit 124.
The sensor (not shown in figure 7) may be arranged in close vicinity of the
portion of the
renal artery 20 at which the electrode elements 122a contact the tissue of the
renal artery 20. This
advantageously may allow for the characteristics of the electrical stimulation
signal to be
determined close to the location of the signal damping device so that the
damping device more
efficiently can generate a damping or counteracting signal.
In a further configuration the cuff 126 of the stimulation device 110 and/or
signal damping
device 120 may be configured to adapt its shape, and more specifically its
inner cross section, to
the vasodilation so as to maintain a certain contact or abutment with the
outer surface of the renal
artery 20. This may for instance be realized by means of a hydraulically or
pneumatically operated
cuff 126 configured to maintain a substantially constant contact pressure
between the artery 20 and
the cuff 126, or by means of a mechanically operated adjustment mechanism
configured to adjust
the inner circumference of the cuff 126 according to the vasodilation.
An example is shown in figure 7b, disclosing a holding device 126, such as a
cuff,
configured to support the electrode arrangement 122a at the outer wall 18 of
the artery and to
define a passage through which the artery passes. The cuff 126 further
comprises a plurality of
abutment elements 127 having a varying volume and being configured to rest
against the outer wall
portion 18 of the artery. The varying volume allows a width of the passage,
through which the
artery passes, to increase with increased vasodilation and decrease with
decreasing vasodilation. In
the example shown in figure 7b the abutment elements comprises inflatable
elements 127 varying
their volume in response to the width of the artery varying. The abutments
elements 127 are
hydraulic or pneumatic elements fluidly connected to a fluid reservoir 128.
The control unit 124
may be configured to cause fluid to be transported between the fluid reservoir
128 and the
inflatable elements 127 based on a contact pressure between the holding device
126 and the outer
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wall 18 of the artery so as to control the volume of the inflatable elements
127 and thus the contact
pressure accordingly. The contact pressure may be determined by means of a
pressure sensor
communicatively connected to the control unit 124. Further, in some examples
the control unit 124
is configured to control an operation of the stimulation device, and thus the
electric stimulation
signal causing vasodilation, based on the signal generated by the sensor
device.
Figure 8 schematically illustrates an example of the innervation of the renal
artery 20, and
shows the kidney 10, the aorta 22 and the renal artery 20 connecting the two.
As mentioned above,
the renal artery 20 may be innervated by renal sympathetic fibres 24
originating from ganglia in the
solar plexus or from the splanchnic nerve collection and connecting the renal
artery 20 as well as
the kidney 10 forming the renal plexus. It is believed that a major part of
the renal plexus
comprises sympathetic nerves 24, but the presence of parasympathetic nerves
may not be excluded.
While the stimulation device 110 and the signal damping device 120 in the
above examples
are described as configured to deliver electric signals, such as the
electrical stimulation signal and
the electric damping signal, directly to tissue of the wall of the renal
artery 20, it will be
appreciated that the electrical stimulation device 20 and the signal damping
device 120 also may be
arranged to act on nerves instead (or in addition). Thus, the stimulation
device 110 may in some
examples be configured to engage and electrically stimulate the nerves 24
innervating the renal
artery 20 to cause vasodilation thereof, thereby promoting a reduction in
systemic vascular
resistance. The electrical stimulation device 110 may be similarly configured
as any of the
stimulation devices described above with reference to the previous figures and
may for instance
comprise one or several electrode elements 112a or contacting portions that
can be attached directly
to the nerve 24, or arranged on a supporting structure, such as a cuff of the
like, which can be
attached to the nerve that that is at least partly encloses the nerve 24. The
stimulating electrode
elements may thus be attached directly to the nerve, at a position between the
innervated muscle
tissue and the spinal cord 20 from which the nerve may origin. It will be
understood that while the
electrode elements can be attached directly onto a wall of the renal artery,
for instance by means of
a patch or stitching, the electrode elements may need to be slightly
differently configured to be able
to engage a nerve instead. Mostly due to the differences in diameter between
the renal artery and a
nerve. In the latter case, the electrode elements may be arranged on the inner
surface of a support
device, such as a cuff, which is dimensioned to be fit snugly around the
nerve. Thus, while electric
stimulation of a wall, or an entire blood vessel, may require the electrode
elements to be arranged
on the wall, the electrode elements may be arranged around the nerve in case a
nerve stimulation is
desired. In some examples the electrode elements 112a are arrange at a
position closer to the
innervated tissue than to the ganglia in the solar plexus or the splanchnic
nerve collection, from
which the nerve 24 may origin. In the present figure, an exemplary
configuration is illustrated in
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sympathetic renal fibers 24 are stimulated at two positions by a respective
electrode element 112a,
each connected to a control unit 124 by means of a lead 112b.
When submitting an electrical stimulation signal to a nerve 24, there is a
risk that the signal
propagates to surrounding tissue which should not be stimulated. The
stimulation signal may for
instance propagate not only to the renal artery wall (which should be
stimulated), but also
'upstream' towards the ganglia from which the nerve 24 origins. This may cause
unwanted
reactions in other parts of the nervous system, and an unpleasant experience
for the patient. To
address this issue, a signal damping device 120 may be arranged to engage the
nerve 24 upstream
of the stimulation device 110, at a position between the stimulation device
110 and the ganglia
from which the nerve 24 origins. In the present figure, a signal damping
device 120 has been
arranged to engage nerves 124 at two different locations 'upstream' the
electrode elements 112a of
the stimulation device 110. The signal damping device 120 may be similarly
configured as any of
the signal damping devices described above with reference to the previous
figures and may for
instance comprise one or several electrode elements 122a or contacting
portions that can be
attached directly to the nerve 24, or arranged on a supporting structure, such
as a cuff of the like,
which can be attached to the nerve that that is at least partly encloses the
nerve 24. The stimulating
electrode elements may thus be attached directly to the nerve, at a position
between the electrode
elements 112a of the stimulation device 110 and the spinal cord 20 from which
the nerve 24 may
origin. The signal damping device 120 may be configured to hinder, damp or
scramble the
electrical signal propagating from the electrode elements 112a of the
stimulation device 110.
Alternatively, the signal damping device 120 may be configured to divert the
propagating
stimulation signals to a lower potential, such as ground.
Alternative, or additional approaches to address potential issues originating
from
unintended or unwanted propagation of the electric stimulation signal may
involve supplying an
additional signal to the tissue in which the electric stimulation signal
propagates, thereby reducing
or at least partly counteracting the tissue's reaction of the stimulation
signal. Such an approach may
rely on a mechanism relating to phase cancellation of the signal, in which the
signal damping
device 120 may be employed to deliver an electric signal to the muscle tissue
of the renal artery 20
or the nervous tissue of the nerve 24, wherein the electric signal is
configured to cancel or at least
reduce the amplitude of the electric stimulation signal that has propagated
from the electrode
elements 112a of the electrical stimulation device 110. Generally, muscle
cells are adapted to react
on nerve fibre action potential waveforms, which in their natural state are
biphasic (negative¨
positive) with a duration in the order of milliseconds. By adding a slightly
phase shifted or reversed
signal damping signal to the muscle tissue, the signal damping signal may be
timed to position its
negative peaks at the time of the positive peaks of the action potential
originating from the
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stimulation signal propagating from the stimulation device 110. With a correct
timing, a significant
phase cancellation and lowering of the action potential waveform may be
achieved, resulting in a
reduced response from the muscle cells.
Figures 9a-d show examples of electrode arrangements according to some
embodiments,
5 which may be implemented in any of the signal damping devices and
stimulation devices discussed
above in connection with for instance figures 4-8.
Figure 9a is an example of a bipolar electrode arrangement comprising a first
and a
second electrode element El, E2, having a plurality of contact portions 122a
which can be arranged
to abut the tissue of the outer wall of renal artery 20 or nervous tissue 24
innervating the renal
10 artery 20. The electrode arrangement may be operated as a bipolar
electrode arrangement by
connecting the first and second electrode elements El, E2 to different
electrical potentials. Thus,
the first electrode element El can be operated as an anode and the second
electrode element E2 as a
cathode. The electrode elements El, E2 may be attached directly to a surface
of the stimulation
device or signal damping device, such as to the inner surface of a support
structure or cuff 126 as
15 exemplified above. In some examples, the electrode elements El, E2 may
be arranged on a support,
such as a flexible patch, which may be configured to be attached to the
tissue, such as the outer
wall of the renal artery or a nerve 124. The electrode arrangement can be
arranged between the
support structure 126 and the tissue (such as disclosed in figure 7) and may
in some examples be
provided as a separate, physically distinct item and in other examples be
integrated in the support
20 structure 126. The electrode arrangement may comprise one or several
contact pads, or contacting
portions 122a, for increasing the contact surface between the electrode and
the tissue when
implanted. During operation, the electrical damping signal (or, when
applicable, the electrical
stimulation signal) may be delivered to the tissue by means of the first and
second electrode
elements El, E2 so as to damp, disturb or counteract the electrical
stimulation signal (when
25 arranged in a signal damping device) and to stimulate contraction of the
muscle cells (when
arranged in an electrical stimulation device).
Figure 9b is another example of an electrode arrangement of an electrical
stimulation
device 110 or a signal damping device 120 as discussed above. In the present
example, the
electrode arrangement may be operated as a unipolar electrode element or as a
bipolar electrode
30 arrangement. The electrode arrangement comprises a first electrode
element El and a second
electrode element E2 which may be formed of a wire or electrical lead arranged
in a flat, coiled
structure for increasing the contact surface between the electrode elements
El, E2 and the tissue.
Further, the coiled configuration allows for a certain mechanical flexibility
of the electrode
elements El, E2 such that they can follow the tissue during vasoconstriction
and vasodilation,
which makes them particularly suitable for direct engagement with the renal
artery 20.
Figure 9c illustrates the end portion of a needle- or pin-shaped electrode
element El, E2,
wherein the active portion of the electrode element El, E2 is provided as a
bare electrode surface
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123 at the end of the electrode element El, E2. Thus, when implanted at or in
the tissue, the active,
bare electrode surface 123 of the electrode element El, E2 may form a
metal¨tissue interface with
the tissue, wherein the interface may surround the end portion of the
electrode element El, E2 so as
to provide a relatively large contact surface. The present example is
advantageous in that it can be
inserted in the tissue, thereby allowing for a selective stimulation at a
certain depth of the smooth
muscle tissue. The electrode element El, E2 may for instance be arranged to
protrude orthogonally
from a surface of the support structure, such as the patch in figures 9a and
b, and the inner surface
of a cuff as illustrated in for instance figures 6 and 7.
Figure 9d shows a similar electrode element El, E2 as the one in figure 9c,
with the
difference that the present electrode element El, E2 comprises an active tip
portion that is covered
by a dielectric material 123' to protect the electrode material from
deterioration during long-term
implantation and to facilitate capacitive current transfer to the tissue. The
dielectric material 123'
may for instance be electrochemically deposited tantalum oxide, which allow
the electrical charge
to pass through the interface but reduces the risk for electrode corrosion,
gas formation and
metabolite reactions.
It will be appreciated that both faradaic and capacitive mechanisms may be
present at the
same time, irrespectively of the type of electrode used. Thus, capacitive
charge transfer may be
present also for a bare electrode forming a metal¨tissue interface, and
faradaic charge transfer may
be present also for a coated electrode forming a dielectric¨tissue interface.
It has been found that
the faradaic portion of the current delivered to the muscle tissue can be
reduced or even eliminated
by reducing the duration of the pulses of the electric signal. Reducing the
pulse duration has turned
out to be an efficient way of increasing the portion of the signal which can
be passed through the
interface as a capacitive current, rather than by a faradaic current. As a
result, shorter pulses may
produce less electrode and tissue damage.
The capacitive portion of the current may further be increased, relative to
the faradaic
portion, by reducing the amplitude of the current pulses of the electrical
signal. Reducing the
amplitude may reduce or suppress the chemical reactions at the interface
between the electrode and
the tissue, thereby reducing potential damage that may be caused by compounds
and ions generated
by such reactions.
In one example, the electrical stimulation may be controlled in such a manner
that a
positive pulse of the electrical signal is followed by a negative pulse (or,
put differently, a pulse of
a first polarity being followed by a pulse of a second, reversed polarity),
preferably of the same
amplitude and/or duration. Advantageously, the subsequent negative (or
reversed) pulse may be
used to reverse or at least moderate chemical reactions or changes taking
place in the interface in
response to the first, positive pulse. By generating a reversed pulse, the
risk of deterioration of the
electrode and/or the tissue at the interface between the electrode and the
muscle tissue may be
reduced.
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Figure 10a is a diagram illustrating a signal damping mechanism, or phase
cancellation
mechanism, according to some embodiments. Figure 10a schematically shows an
electric
stimulation signal comprising a series of positive pulses PL1, and an electric
damping signal
comprising a series of negative pulses PL2. The stimulation signal may
originate from a
stimulation device 110 arranged to cause vasodilation in the renal artery 20,
whereas the electric
damping signal may be generated by a signal damping device 120, comprising a
control unit which
may be arranged outside the body or be implanted in the body. The control unit
may be operatively
connected to an electrode arrangement by means of one or several leads. The
electrode
arrangement may comprise a plurality of electrode elements attached to the
muscle tissue of the
renal artery wall 20, to tissue in close vicinity of the muscle tissue of the
renal artery, or a nerve
innervating the renal artery, such that the electrode elements are allowed to
deliver the damping
signal to said tissue. The electrical signals shown in the present figure may
either reflect the signal
as generated at the stimulation device and signal damping device,
respectively, or the signal as
delivered to the tissue. In the present example, the electrical signals are
pulsed signals comprising
square waves PL1, PL2. However, this may be considered to represent an ideal
signal, and it is
appreciated that other shapes of the pulses may be provided as well. The pulse
signals may be
periodic, as shown, or intermittent (i.e., multiple series of pulses separated
by periods of no pulses).
The pulses may have an amplitude Al, A2, which may be measured in volts,
amperes, or the like.
Each of the pulses of the signals may have a pulse width D1, D2. Likewise, if
the signal is periodic,
the pulsed signals may have a period Fl, F2 that corresponds to a frequency of
the signal. Further,
the pulses may be either positive or negative in relation to a reference. In
the present example, the
signal originating from the propagating stimulation signal may comprise
positive pulses PL1
whereas the damping signal may comprise negative pulses PL2.
In the present example, the electric stimulation signal may be a pulsed signal
comprising
square waves having a frequency in the range of 0.01-150 Hertz. The pulse
duration may lie within
the range of 0.01-100 milliseconds (ms), such as 0.1-20 ms, and preferably
such as 1-6 ms. The
natural muscle action potential has in some studies been observed to last
about 2-4 ms, so it may be
advantageous to use a pulse duration imitating that range when stimulating the
tissue to cause it to
relax.
The amplitude of the stimulation signal may for example lie within the range
of 1-15
milliamperes (mA), such as 0.5-5 mA, in which range a particularly good muscle
response has been
observed in some studies.
In a preferred, specific example, the electrical stimulation delivered by the
stimulation
device 120 may hence be performed using a pulsed signal having a pulse
frequency of 10 Hz, a
pulse duration of 3 ms and an amplitude of 3 mA. The pulsed signal shown in
figure 10a (in solid
lines) may be considered to represent the characteristics of such a
stimulation signal as it is
propagating through the tissue of the renal artery 20.
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The damping signal (indicated by dashed lines) may be designed to counteract,
or mitigate,
the tissue's response to the stimulation signal. In the example shown in the
present figure, this may
for instance be achieved by providing a series of pulses PL2 having a polarity
that is reversed in
relation to the pulses PL1 of the signal originating from the stimulation
signal. Further, the
damping signal may be phase shifted in relation to the positive pulses. The
timing of the signals
may hence be selected such that the negative pulses PL2 are positioned at the
time of the positive
peaks PL1, or slightly delayed relative the positive peaks PL1, as indicated
in figure 10a. A
negative pulse PL2 may be delivered to the tissue shortly after the positive
pulse, before the cells
have had time to react to the stimuli provided by the positive pulse. Put
differently, the damping
signal may be delivered to the cells at the onset of the change in cell
polarization, thereby reducing
or cancelling cell polarization. The negative pulse PL2 may thus act to
counteract, or cancel, the
stimuli provided by the positive pulse PL1, thereby preventing the cells from
contract, or at least
reducing the contraction triggered by the positive pulse PL1.
It should be understood that the signals illustrated in the above example are
schematic and
ideal, and not necessarily a true representation of the actual signals
delivered to the tissue. The
actual signals may be more complex, having a more complex frequency
composition and
comprising various degrees of noise. The illustration in figure 10a is
purposely simplified to help
elucidate the inventive concept of applying a damping signal to counteract or
reduce the effects of
the stimulation signal as it propagates to other parts of the body which are
not the primary target of
the stimulation. It may therefore be advantageous to provide a sensor
measuring the signal, which
is to be damped or counteracted, and design the damping signal based on input
from the sensor.
This allows for the damping signal to be generated also in cases where the
stimulation signal varies
over time or is difficult to estimate or model. By such a feedback loop, a
more flexible damping
may be provided.
As mentioned above, the signals do not necessarily have to be formed of pulses
or square
waves. Figure 10b illustrates another (still simplified) example, wherein the
signal originating from
the stimulation signal is shaped as a sine wave, and wherein the damping
signal has a
corresponding shape and is phase shifted to counteract or cancel the
stimulation signal. Other
signal shapes are however equally possible, including square, triangle and
sawtooth waves and
-- combination thereof.
A further example is shown in figure 10c, in which the damping signal is
configured to
disturb or "scramble" the signal originating from the stimulation device 110
such that it has a
reduced effect on tissue arranged remote from the electrode elements 112a of
the stimulation
device 110. The damping signal may for instance comprise a frequency which is
higher than the
frequency of the signal from the stimulation device 110, such that the
resulting, superposed signal
that reaches the individual tissue cells are less suitable for triggering a
contraction of the smooth
muscle tissue cells or a conveying of the stimulation signal by the nervous
tissue cells. This is
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based on the observation that a stimulating signal may have a reduced impact
on cells when the
frequency is outside a certain interval. Put differently, the stimulation of
tissue may be less efficient
for higher frequencies, and the damping signal may therefore be applied to
increase the frequency
accordingly.
Figure 11 is a schematic outline of a device, or system, for treating a
patient with
hypertension. The system may comprise an implantable stimulation device 110
and, optionally, an
implantable signal damping device 120, which may be similarly configured as
the stimulation and
signal damping devices discussed above in connection with the previous
examples. The system
may further comprise an implantable source of energy, or energy storage unit
130, for energizing
the stimulation device 110 and the signal damping device 120 and providing the
electrical energy
required for generating the electrical stimulation signal and the electric
damping signal. Further, the
system may comprise a control unit or controller 150 configured to control the
generation of the
stimulation signal and/or the damping signal, and a sensor configured to
generate input that can be
used for generating the damping signal.
Any of the above elements, such as the energy storage unit 130, the sensor
140, and the
controller 150, or parts thereof, may be configured to be attached to a tissue
wall of the body by
means of a holding device as discussed in connection figures 26-45.
The energy storage unit 130 may for instance be of a non-rechargeable type,
such as a
primary cell, or of a rechargeable type, such as a secondary cell. The energy
storage unit 130 may
be rechargeable by energy transmitted from outside the body, from an external
energy storage unit,
or be replaced by surgery when needed.
The controller 150 may comprise an electric pulse generator for generating
electrical pulses
to the stimulation signal and/or the damping signal. The controller 150 may be
integrated with the
energy storage unit 130 or provided as a separate, physically distinct unit
which may be configured
to be implanted in the body or operate from the outside of the body. In case
of the latter, it may be
advantageous to allow an external control unit to communicate wirelessly with
the controller 150
for example by means of a communication unit of a more general controller (not
shown). The
external controller may for example be a wireless remote control, and the
controller may in such
cases advantageously comprise an internal signal transceiver configured to
receive and transmit
communication signals from/to an external signal transmitter. More detailed
examples are disclosed
in connection with figures 24a-f and 25.
In some examples, the controller 150 may be configured to generate a signal
indicating a
functional status of the source of energy 130, such as for instance a charge
level or a temperature of
the source of energy 130. Further, the control unit 150 may in some examples
be configured to
indicate a temperature of at least one of the stimulation device 110, the
signal damping device 120
and tissue adjacent to the stimulation device 110 or the signal damping device
120.
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In some cases, the system comprises a sensor 140, which may be configured to
sense a
physical parameter of the body and/or the implantable device. The sensor may
be similarly
configured as the sensors discussed below in connection with figures 12a-d,
13a-b and 14. The
sensor 140 may for example be employed to sense or detect a stretching or
contraction of the outer
5 wall of renal artery 20, thereby allowing for the vasoconstriction and
vasodilation of the renal
artery 20 to be monitored. The sensor 140 may in this example comprise a
strain gauge configured
to indicate a strain of the outer wall of the renal artery 20. In an example,
the relaxation of the
blood vessel may be verified by means of the sensor 140 and the stimulation
device 110 controlled
accordingly. The stimulation device 110 may for example modify the stimulation
signal based on
10 feedback from the sensor 140 pertaining to the muscular response to the
stimulation signal, which
advantageously may allow for the stimulation signal to be modified to improve
or increase the
vasodilation in the renal artery 20. In further examples, the sensor 140 may
comprise a pressure
sensor configured to generate a signal indicating a pressure in the renal
artery 20. The signal
indicating the pressure in the blood vessel may for instance be sent to the
controller 150 and used
15 as input for adjusting the electrical stimulation signal affecting the
vasomotor tone of the smooth
muscle tissue of the renal artery 20.
In further examples, the sensor 140 may be configured to generate a signal
indicative of
electrical properties of the signal propagating from the stimulation device
110, such as the signal
propagating towards regions of the body which should not be stimulated by the
stimulation signal.
20 Examples of such regions may for instance include the aorta 22 and
ganglia from which the nerves
innervating the renal artery origin. The sensor 140 may for example include a
voltage sensor and/or
a current sensor and may be configured to deliver information to the
controller 150 pertaining to for
instance voltage, amplitude and frequency of signals propagating from the
electrode elements 112a
of the stimulation device 110.
25 The controller 150 may be configured to use this information to generate
a damping signal
which can be supplied to for instance the tissue of the renal artery, close to
the bifurcation with the
aorta, or at least reducing the tissue's muscular response to the propagated
stimulation signal. The
sensor may for example be structurally integrated with the signal damping
device 120, or provided
as a separate, structurally distinct unit. In some examples, the sensor may
comprise one or several
30 electrode elements or electrical probes, which may be arranged to engage
the nerve or muscular
tissue through which the signal from the stimulation device passes.
In some examples, the sensor 140 may be configured to sense or detect action
potentials
that are being transmitted to the muscle tissue. The action potentials may be
registered by the
sensor 140 and information relating to the action potentials be transmitted to
the controller 150.
35 The controller 150 may use the received information when controlling the
signal damping device
120 to reduce the effect of the electric stimulation signal on tissue to which
the electrical
stimulation signal has propagated.
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As mentioned above in connection with figure 11 it will be appreciated that
any of the
above embodiments, such as the arrangement disclosed in figure 4-8, may
include a sensor
configured to generate a signal indicative of a blood pressure (or vascular
resistance) of the patient.
Examples of such sensors will be described in the following with reference to
figures 12-14. The
various examples and embodiments of sensors described in the following may
thus be combined
with any of the above discloses systems and devices for causing electrically
induced vasodilation of
the renal artery, and the description of such systems and devices will
therefore not be repeated in
the following.
The inventive concept may utilize sensors of a transducer type, in which
energy is
converted from one form to another. The sensor may thus be configured to
convert a pressure
signal (measured directly in the blood or indirectly via an intermediate
medium, such as the wall of
the blood vessel) into for instance an electrical signal which thus may be
considered to be a
function of the pressure.
The sensor may be of a dynamic type, configured to capture or monitor the
pressure over
time and generate a signal indicating the pressure for each measurement point
(or continuously,
depending on sensor type). The control unit, to which the signal may be sent,
may then analyses the
signal and make the decision to initiate or stop the stimulation of the renal
artery. Alternatively, the
sensor may be of a switch type which is configured to turn on or off at a
particular pressure. For
example, the sensor may be configured to generate a trigger signal for blood
pressures being above
a certain threshold (or, in alternative configurations, for blood pressures
being below a certain
threshold). In such cases, the control unit may be configured to treat the
signal as a trigger or ON
signal, initiating the stimulation of the muscle tissue of the renal artery.
In different words, the
values of the signal from the sensor may either be (substantially) continuous
(giving a substantially
true representation of any changes in the measured quantity) or binary,
indicating whether the
measured quantity is above or below a given limit.
The sensor may be configured to measure the pressure relative to a reference
pressure, such
as perfect vacuum. This type of sensor may be referred to as an absolute
pressure sensor. The
sensor may also be a differential pressure sensor, configured to measure the
difference between two
pressures, such as the pressure inside the blood vessel compared to the
pressure outside the blood
vessel, or the atmospheric pressure. This type of sensor is sometimes referred
to as a gauge
pressure sensor.
The pressure sensor may be of a force collector type, using a force collector
(such as a
diaphragm, piston, bourdon type, or bellows) to measure strain (or deflection)
due to applied force
over an area (pressure). The sensor may for example utilize piezoelectric or
piezoresistive effects to
detect strain due to applied pressure or employ a variable capacitor
technology to generate a signal
as pressure deforms for instance a diaphragm. Pressure induced displacements
of elements of the
sensor (or parts of the patient's body) may also be measured by means of
changes in inductance,
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Hall effect, eddy currents and the like. In further examples, electrically
conductive strain gauges
may be attached to an area which moves due to applied pressure and used for
generating a signal
indicative of the movement of the area. In yet further examples the sensor may
operate based on an
optical technique, including the use of the physical change of an optical
fiber to detect strain due to
applied pressure or optical coupling. Alternatively, or additionally, changes
in the blood flow may
be measured using optical methods, involving for instance radar or doppler
effects, or by
monitoring the optical coupling efficiency of light passing through the blood
vessel. These
principles may utilize the observations that light may behave differently
depending on the pressure
in the blood. Non-limiting details and examples will be discussed in further
detail in the following.
1 0 The sensor may be arranged at the renal artery, preferably the same
renal artery as the one
to which the electrical muscle tissue stimulation is applied. A merit of this
arrangement is that the
sensor may deliver a signal indicating pressure changes resulting from
vasodilation of the renal
artery and can therefore be considered to provide a more direct feedback to
the stimulation process.
Put differently, a control loop may be achieved, which utilizes feedback data
that are obtained from
the same blood vessel as the one that is being electrically stimulated.
Alternatively, or additionally, a sensor may be arranged elsewhere, i.e.,
remote from the
renal artery which is electrically stimulated. One or more sensors may hence
be arranged at a blood
vessel in another part of the patient's body, such as the aorta, or an artery
in the abdomen or a limb
of the body, to generate a signal indicative of a systemic blood pressure of
the patient. It may be
advantageous to arrange the sensor at a position which is easier to access
than the renal artery,
allowing for the sensor to be implanted in a less complicated and invasive
surgical procedure.
The sensor may be configured for long-term implantation, or permanent
implantation, in
which the sensor is expected to be operating for several months or years
without having to be
replaced or physically accessed. This allows for the sensor to be operable
continuously during the
operation of the stimulation device. Alternatively, the sensor may be
configured for a temporal use,
for instance during a shorter period in which the stimulation device is
calibrated. The sensor may
thus be implanted for a few hours, days or weeks, for example during setup or
calibration of the
stimulation device, whereafter the sensor may be removed.
According to some embodiments, the sensor may be arranged to measure the
pressure
directly in the blood vessel. This may for example be achieved by arranging a
probe inside the
blood vessel, such as the renal artery, or another artery such as the radial
artery, femoral, dorsalis
pedis or brachial artery. The probe may thus be employed to generate a signal
indicative of the
pressure acting on the probe, thereby giving an indication of the blood
pressure.
According to some embodiments, the pressure sensor may be arranged at an outer
wall of
the blood vessel of the patient. The sensor may for example be formed as a
cuff at least partly
enclosing the blood vessel or be arranged to abut at least a portion of the
outer wall. By this
arrangement, the sensor may be configured to measure pulse waves transmitted
by the blood into
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the wall of the blood vessel. The pulse waves transmitted through the wall may
be converted into a
signal, such as an electrical signal, by means of a strain gauge reacting on a
strain induced in the
wall portion by the pressure pulses, or by means of a contact pressure sensor
configured to react or
monitor a contact pressure between the outer wall portion and the sensor. A
pulse wave,
transmitted through the blood, may hence give rise to an increased pressing
force between the outer
wall of the blood vessel and the pressure sensor, which in turn may be
configured to convert the
increased pressing force into a signal indicative of the pressure according to
a technique mentioned
above.
According to some embodiments, the sensor may comprise a light source
configured to
1 0 input light into the blood, such as through the wall portion of the
blood vessel, and a light sensor
configured to receive light transmitted from the light source. The light
sensor may for instance be
arranged outside the blood vessel, at a side opposing the light source. This
may be referred to as an
optical sensor, which in some examples may base the pressure measurements on a
light coupling
efficiency through the blood vessel. The light coupling efficiency may for
instance be a function of
a contact pressure between the light source and the wall portion of the blood
vessel, and/or a
contact pressure between the light sensor and a wall portion of the blood
vessel and may therefore
be used to indicate a characteristic of the pressure pulse generated by the
heartbeats. Optical
methods may also be used to measure a deflection, or movement, of a wall
portion of the blood
vessel in response to the pressure pulse wave travelling through the blood
vessel. Such an optical
.. method may for instance utilize the doppler radar effect to monitor a pulse
wave causing a
movement in the wall portion of the blood vessel.
According to some embodiments, the sensor may operate according to the
auscultatory
principle, in which a constrictive element, or constriction device, is placed
around the blood vessel
and operated to constrict the blood vessel until is occluded and the blood
flow therein stopped. The
constriction may then be gradually released, and the constrictive pressure
registered as a function
of the returning blood flow. In an example, the constriction device is used in
an oscillometric
method, in which oscillations in the constrictive pressure caused by
oscillations in the blood flow,
i.e., the pulse, are measured. The constriction device may for instance be
operated to a pressure
initially exceeding the systolic arterial pressure and then reduce to below
the diastolic pressure.
When blood flow is substantially nil (constrictive pressure exceeding systolic
pressure) or
substantially unimpeded (constrictive pressure below diastolic pressure), the
constrictive pressure
may be essentially constant. When blood flow is present, but restricted, the
constrictive pressure,
which may be monitored by the sensor, may vary periodically in synchrony with
the cyclic
expansion and contraction of the blood vessel, i.e., it will oscillate. Over
the release period, in
which the constrictive pressure is reduced, the recorded pressure waveform may
form a signal from
which the oscillometric pulses may be extracted using a bandpass filter. The
extracted oscillometric
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pulses may form a signal referred to as the oscillometric waveform, OMW, which
can be analyzed
and processed to estimate the systolic, diastolic and mean arterial pressure.
The sensor may in some examples be configured to generate a signal indicative
of a
vascular resistance of a blood vessel of the patient. As the blood pressure
may be understood as a
function of (inter alia) the vascular resistance, this measure may be used
when estimating the blood
pressure. The sensor may for instance be configured to measure a flow of blood
in the blood vessel,
to measure a vasodilation or vasoconstriction of the blood vessel, and/or a
size of the blood vessel
(such as inner or outer diameter or cross-sectional size). The blood flow
through the blood vessel
may for instance be monitored by means of a light coupling method as indicated
above, where the
composition of the blood is monitored to estimate a flow of the blood. This
may for example
involve observing or estimating a number of red blood cells passing a certain
region or volume of
the blood cell per unit of time. An increase in blood flow may indicate a
reduced vascular
resistance, whereas a reduced blood flow may indicate an increased vascular
resistance.
Various examples of sensors, which all may operate as outlined above, will now
be
discussed with reference to figures 12a-d, 13a-b and 14. It will be
appreciated that the below
sensors may be combined with any of the above arrangements disclosed in for
instance figures 4-8
for causing electrically induced vasodilation of the renal artery. The
description of such systems
and devices will not be repeated in the following.
Figures 12a-d show examples of sensors 140 for generating a signal indicative
of a blood
pressure, a vascular flow, or a vascular resistance, in a blood vessel 20 of a
patient. The blood
vessel 20 may for instance be a renal artery of the patient, or another artery
such as the radial
artery, femoral, dorsalis pedis or brachial artery. In some examples the blood
vessel may be a vein.
The sensors 140 may be for instance be configured to convert a pressure signal
into another signal,
such as an electrical signal, indicative of the pressure in the blood vessel
20. This signal may be
transmitted to a control unit (not shown) configured to control an operation
of a stimulation device
as previously discussed in the present disclosure. The transmission between
the sensor 140 and the
control unit may take place over a wired or wireless communication channel,
which for example
may be formed of one or more electrical leads interconnecting the control unit
and the sensor.
Figure 12a shows an example of a sensor 140 configured to be arranged to
measure the
pressure directly in the blood vessel 20. The sensor 140 may hence comprise a
probe 142
configured to penetrate a wall portion of the blood vessel 20 and be arranged
within the lumen, or
blood passageway defined by the interior of the blood vessel 20. The sensor
may further comprise a
body part configured to be arranged on the outside of the blood vessel 20. The
body part may for
example be configured to be attached or secured to the outer surface of the
wall. The probe 142
may be provided at an underside of the body part so as to allow the probe to
extend into the interior
of the blood vessel 20 when the body part is attached to the wall part of the
blood vessel 20.
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Figure 12b shows an example of an optical sensor 140 for measuring blood
pressure pulses
transmitted through the walls of the blood vessel 20. The sensor 140 may
comprise a light source
141 and a light sensor 143 configured to be arranged on opposite sides of the
blood vessel such that
light from the light source 141 can be transmitted through the blood vessel 20
and the blood
5 .. flowing therethrough. In an example, the light is transmitted from the
light source 141 through a
light transmitting body 141' towards the blood vessel 20. The light
transmitting body 141', or light
guide 141', may comprise a convex surface being curved towards the outer wall
of the blood vessel
20. The curved surface may be arranged to abut the outer wall, such that a
contact area is provided
at the interface between the blood vessel 20 and the light transmitting body
141'. It has been
10 observed that the size of the contact area may vary with the contact
force between the blood vessel
20 and the light transmitting body 141' (i.e., the force with which the
surfaces of the blood vessel
20 and the light transmitting body 141' abuts each other), such that an
increased contact area is
achieved when the wall of the blood vessel 20 is pushed against the light
transmitting body 141'
and a reduced contact area is achieved when the contact force between the wall
of the blood vessel
15 and the light transmitting body 141' is reduced. By arranging the sensor
140 such that it abuts the
outside of the wall of the blood vessel 20, the contact area between the two
may be caused to vary
in size with the pressure pulse waves transmitted through the blood vessel 20.
It has further been
observed that the light coupling efficiency through the blood vessel 20, for
example measured as
the percentage of the light generated by the light source 141 that is
registered by the sensor 143,
20 may vary with the size of the contact area between the light
transmitting body 141' and the wall of
the blood vessel 20. Hence, the variations in the signal at the light sensor
143 may be analyzed to
calculate a corresponding variation in contact pressure and thus get an
indication of the pressure in
the blood vessel 20. As indicated in the present figure, there may
alternatively, or additionally, be
provided a light transmitting body 143' arranged at the light sensor side,
which may be configured
25 and function in a similar way as described above.
The light transmitting body 141', 143' may in some examples be rigid so that
the variations
in contact area are caused by the wall of the blood vessel 20 deforming rather
than the light
transmitting body 141', 143' deforming. In further examples the light
transmitting body 141', 143'
may be flexible, allowing it to deform with an applied contact force between
the blood vessel and
30 the light transmitting body 141', 143'.
The sensor 140 may comprise a holding structure, such as a cuff 144,
configured to at least
partly enclose the blood vessel 20 and push the light transmitting body (or
bodies) 141', 143'
against the outer wall of the blood vessel 20. The holding structure may be
similarly configured as
the one disclosed in connection with figures 5-7.
35 Another embodiment, which may be similar to the one illustrated in
figure 12b, may
operate based on acoustic waves instead of optical principles. Such a sensor
140 may hence
comprise an acoustic transducer instead of the light source 141 and an
acoustic sensor instead of
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the light sensor 143. Still, the coupling efficiency through the blood vessel
may be determined as a
function of a varying contact area between the sensor 140 and the outer wall
of the blood vessel 20,
allowing for a signal to be generated which is indicative of the pulse waves
travelling through the
blood vessel 20. Similar to the optic version above, the coupling efficiency
of the sound may
increase with increasing contact area and decrease with decreasing contact
area, as the pulse wave
passes by.
Figure 12c show an example of a sensor 140 operating by means of a doppler
radar
principle, in which a beam of electromagnetic (or acoustic) waves is sent from
a transmitter 147
and reflected from the outer wall of the blood vessel. Assuming that the wall
moves slightly back
and forth along a radial direction of the vessel as the pulse wave passes
through the vessel, the
movement may be determined based on a slight change in frequency of the
reflected waves. These
changes may be observed by the transmitter 147 and used as a basis for
generating a signal
indicative of the pressure in the blood vessel 20.
Figure 12d shows a further example of a sensor 140, which may be configured as
a strain
sensor generating a signal in response to strain induced in the wall by the
pressure variations
caused by the patient's pulse beats. The sensor 140 may for example operate
based on a capacitive
principle, in which the capacitance between two electrodes 145, 146 may vary
with varying
structural dimensions between the electrodes 145, 146. The electrodes 145, 146
may for instance
comprise a first and a second interdigitated finger electrodes, having a
separation which may vary
with induced strain in the wall of the blood vessel 20. An increased
separation between the
electrodes 145, 146 may be observed as a reduced capacitance, indicating an
increased strain in the
wall, whereas a reduced separation may be observed as an increased
capacitance, indicating a
reduced strain in the wall. Further, the strain sensor 140 may be used to
measure a vasodilation
and/or vasoconstriction in the blood vessel 20.
Figures 13a and b show an example of a sensor 140 formed of a constriction
device
configured to at least partly constrict, or at least push against the outer
wall of, the blood vessel 20.
The sensor 140 in some examples operate according to the auscultatory
principle, in which the
blood pressure is measured by constricting the blood vessel until it is
occluded, and the blood flow
substantially stopped, and in other examples according to an oscillometric
method in which
oscillations in a constrictive pressure applied by the constriction device
(which hence not
necessarily is operated to fully close the blood flow passageway) are
measured.
The constriction device 140 in figure 13a may hence be configured to constrict
a wall
portion of the of a blood vessel 20, such as the renal artery or another
artery which may be more
easily accessed for the implantation procedure. The constriction device 116
may comprise a
surrounding structure, or support structure, having a periphery arranged to
surround the blood
vessel 20 when implanted. The surrounding structure may be configured to
support one or several
constriction elements configured to expand inwards, towards an opposing wall
of the surrounding
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structure, to abut the outer wall of the blood vessel 20 and thereby allowing
pressure pulses
induced by the blood pressure in the vessel to be transmitted into the
constriction elements. Further,
in some examples, the constriction elements may be operable to close the
passage through the
blood vessel to allow the blood pressure to be measured using the auscultatory
principle.
In the example shown in the present figure, the surrounding structure
comprises two
support elements 64a, 64b connected to each other for forming the surrounding
structure. The first
support element 64a may be configured to support a first operable hydraulic
constriction element
601a and a second operable hydraulic constriction element 60 lb. The second
support element 604b
may be configured to support a third operable hydraulic constriction element
601c and a fourth
operable hydraulic constriction element 601d. The first, second, third and
fourth operable hydraulic
constriction elements 101a-d may be configured to constrict the blood vessel
20 for restricting the
flow and configured to release the constriction when so desired.
The first and second support elements 64a, 64b each comprises a curvature C
adapted to
follow the curvature of the portion of the blood vessel 20 at which the
pressure sensor 140 is
.. arranged, such that the pressure sensor 140 snuggly fits around the blood
vessel 20 and the distance
which the operable hydraulic constriction elements 604a-d needs to expand to
abut or even
constrict the blood vessel 20 is reduced.
The first and second support elements 64a, 64b may be hingedly connected to
each other
such that a periphery of the surrounding structure is possible to open,
thereby allowing the
surrounding structure to be placed around the blood vessel 20. A first end of
the first and second
support elements 64a, 64b may comprise a hinge 66, whereas the other ends of
the first and second
support elements 64a, 64b may comprise portions of a locking member 67', 67",
each comprising
protruding snap-lock locking members materially integrated in the first and
second support
elements 64a, 64b and configured to be snapped together for closing the
periphery of the
surrounding structure, thereby allowing the surrounding structure to partially
or completely encircle
the blood vessel 20.
The constriction elements may be hydraulically connected to a pressure sensor
configured
to register pressure pulses induced in the constriction elements by the
pressure pulses travelling
through the blood vessel. The registered pressure pulses may then be converted
in to a signal that is
indicative of the blood pressure in the blood vessel and transmitted to the
control unit as discussed
above.
In the embodiment shown in figure 13a, each of the first and second support
elements 64a,
64b comprises fluid conduits 609a-d partially integrated in the support
elements 64a, 64b. In the
first support element 64a a first conduit 609a comprises a first portion in
the form of a first tubing
.. which enters a tubing fixation portion 65a fixated to, or materially
integrated with, the first support
element 64a. In the tubing fixation portion 65a the fluid conduit 109a is
transferred into a first
integrated channel 23a in the first support element 24a. The first support
element 64a may comprise
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an inner surface 68a which configured to be oriented to face the wall of the
blood vessel 20, when
the sensor 140 is implanted. The inner surface 68a of the first support
element 64a may comprise a
fixation surface for fixating the first and second operable hydraulic
constriction elements 601a,
60 lb. The fixation surface also comprises an outlet from the first integrated
channel 63a into the
first operable hydraulic constriction element 601a, such that fluid can be
transferred from the first
tubing to the first integrated channel 63a and into the first operable
hydraulic constriction element
601a for expanding the first operable hydraulic constriction element 601a.
A second tubing of the second fluid conduit 609b may also enter the tubing
fixation portion
65a fixated to, or materially integrated with, the first support element 64a.
In the tubing fixation
portion 65a the second fluid conduit 609b is transferred into a second
integrated channel 63b in the
first support element 64a. The fixation surface also comprises an outlet from
the second integrated
channel 63b into the second operable hydraulic constriction element 60 lb,
such that fluid can be
transferred from the second tubing to the second integrated channel 63b and
into the second
operable hydraulic constriction element 601b for expanding the second operable
hydraulic
constriction element 60 lb.
The second support element 64b may, similar to the first support element 64a,
comprise a
fixation surface for fixating a third and fourth operable hydraulic
constriction element 601c, 601d
operated by fluid supplied by third and fourth fluid conduits 609c, 609d as
illustrated above with
reference to the first and second constriction elements 601a, 60 lb.
The tubing portion of the fluid conduits 109a-d is preferably made from a
biocompatible
material such as silicone and/or polyurethane.
Integrating the fluid conduit(s) in the support element(s) enables the fluid
entry to the
operable hydraulic constriction elements 601a-d to be protected and
encapsulated by the support
element(s) which reduces the space occupied by the constriction device 116.
Further, it may reduce
the amount of protruding portions, thereby reducing the risk of damaging the
tissue of the blood
vessel 20 around which it is implanted.
The first, second, third and fourth operable hydraulic constriction element
601a-d may be
connected to a shared hydraulic system, such that the abutment against the
wall of the blood vessel
as well as any potential constriction of the blood flow passageway may be
regulated by pumping
the hydraulic fluid to and from the constriction elements 60 la-d.
Alternatively, one or several of
the hydraulic constriction elements 60 la-d are individually controllable,
such that for instance the
first and third hydraulic construction elements 601a, 601c share a first
hydraulic system and the
second and fourth hydraulic constriction elements 60 lb, 601d share a second
hydraulic system,
separate from the first hydraulic system. This advantageously allows for the
first and third
constriction elements 601a, 601c to be inflated at the same time as the second
and fourth
constrictions elements 60 lb, 601d are deflated. Further, one or several of
the hydraulic constriction
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elements may be connected to a hydraulic pressure sensor for measuring
pressure variations in the
constriction element(s) caused by the pulse waves in the blood vessel 20.
The first and third constriction elements 601a, 601c may have a respective
volume that is
larger than a respective volume of the second and fourth constriction elements
60 lb, 601d. In the
embodiment of figures 13a and b, the first and third constriction elements
601a, 601c may have a
respective volume that is more than 1.5 times larger than the respective
volumes of the second and
fourth constriction elements 60 lb, 601d. However, it is also conceivable that
the first and third
constriction elements 601a, 601c have a respective volume that is more than 2
times as large as the
volume of the second and fourth constriction elements 60 lb, 601d.
The sensors shown in figures 12a-d and 13a-b may be connected to, or form part
of, a
stimulation device 110 for causing electrically induced vasodilation in a
renal artery of a patient.
As example of such an implementation is illustrated in figure 14, wherein a
stimulation device 110
similar to the one discussed with reference to figure 4 is implanted together
with a sensor 140
similar to the one disclosed in connection with figures 13a-b. As shown in
figure 14, both the
stimulation device 110 and the sensor 140 may be arranged to act on the renal
artery 20 of the
patient, with the stimulation device 110 configured to electrically stimulate
smooth muscle tissue of
a wall portion of the renal artery 20 and the sensor 140 arranged as a cuff at
least partly enclosing
the renal artery 20. The cuff comprises at least two inflatable elements
arranged to abut the outer
wall of the renal artery. The inflatable elements are connected to an
operation device 148 for
varying a contact pressure between the inflatable elements and the renal
artery. The operation
device 148 may for instance be a hydraulic device configured to move a
hydraulic fluid to and from
the inflatable elements to adjust their inflation. The sensor 140 may be
communicatively connected
to a control unit, or controller 114, of the stimulation device 110 to provide
the control unit 114
with a signal indicative of a pressure in the renal artery 20. This signal may
be used by the control
.. unit 114 for controlling the stimulation and hence the vasodilation of the
renal artery 20.
In the following, a detailed description will be given of a technology for
electrically
stimulating tissue, such as the above renal artery 20, for exercising the
tissue and thereby
improving the conditions for long term implantation. The body tends to react
to a medical implant,
partly because the implant is a foreign object, and partly because the implant
interacts mechanically
with tissue of the body. Exposing tissue to long-term engagement with, or
pressure from, an
implant may deprive the cells of oxygen and nutrients, which may lead to
deterioration of the
tissue, atrophy and eventually necrosis. The interaction between the implant
and the tissue may also
result in fibrosis, in which the implant becomes at least partially
encapsulated in fibrous tissue. It is
therefore desirable to stimulate or exercise the cells to stimulate blood flow
and increase tolerance
of the tissue for pressure from the implant.
In the following, the use of electric signals for exercising tissue to improve
the conditions
for long term implantation will be described. It should be noted that there
may be a difference
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between the electric stimulation signal (as well as the signal damping signal)
discussed above in
connection with for instance figures 4-7, and the electric signal delivered
for improving long term
implantation conditions. While the former signal may be specifically adapted
to trigger a muscular
response for inducing vasodilation, the latter may be provided with the
primary aim of preventing
5 deterioration of the tissue and eventually necrosis of tissue of the
renal artery. Preventing or
reducing tissue deterioration does not necessarily require a stimulation
causing the same degree of
response as needed for inducing vasodilation. On the contrary, it may be
advantageous to deliver an
electric signal inducing a stimulation of the tissue stimulation (i.e.,
motoric response) without
substantially affecting the flow resistance in the blood vessel. The
"exercising" of the tissue to
10 prevent deterioration may hence be combined with the stimulating causing
vasodilation, and
preferably cycled such that exercising cycles are performed between
vasodilation cycles. The
exercising, which thus may differ in effect or muscular response from the
vasodilation, may be
performed by delivering an exercising signal to the tissue via the electrode
arrangements of the
stimulation devices and/or damping devices discussed with reference to e.g.
figures 4-7. It may be
15 particularly advantageous to combine the exercising of the muscle tissue
with medical devices
comprising support structures, such as the cuff 116 shown in figures 5 and 7
and the sensors figures
12a-d, 13a-b and 14. As these may form a relatively large contact surface with
the tissue against
which they are arranged (compared to the electrodes attachments shown in e.g.
figure 4), there is an
increased risk for a negative impact on the health of the tissue.
20 The electrical electrode arrangement and exercising methods described in
the following
may thus be implemented in any of the embodiments of the stimulation devices,
signal damping
devices, and sensors described above for the purpose of exercising the tissue
which is in contact
with such medical devices or implants.
Muscle tissue is generally formed of muscle cells that are joined together in
tissue that can
25 be either striated or smooth, depending on the presence or absence,
respectively, of organized,
regularly repeated arrangements of myofibrillar contractile proteins called
myofilaments. Striated
muscle tissue is further classified as either skeletal or cardiac muscle
tissue. Skeletal muscle tissue
is typically subject to conscious control and anchored by tendons to bone.
Cardiac muscle tissue is
typically found in the heart and not subject to voluntary control. A third
type of muscle tissue is the
30 so-called smooth muscle tissue, which is typically neither striated in
structure nor under voluntary
control. Smooth muscle tissue can be found in the wall of the renal artery 20,
as previously
discussed.
The contraction of the muscle tissue may be activated both through the
interaction of the
nervous system as well as by hormones. The different muscle tissue types may
vary in their
35 response to neurotransmitters and endocrine substances depending on
muscle type and the exact
location of the muscle.
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A nerve is an enclosed bundle of nerve fibers called axons, which are
extensions of
individual nerve cells or neurons. The axons are electrically excitable, due
to maintenance of
voltage gradients across their membranes, and provide a common pathway for the
electrochemical
nerve impulses called action potentials. An action potential may be understood
as an all-or-nothing
electrochemical pulse generated by the axon if the voltage across the membrane
changes by a large
enough amount over a short interval. The action potentials travel from one
neuron to another by
crossing a synapse, where the message is converted from electrical to chemical
and then back to
electrical.
The distal terminations of an axon are called axon terminals and comprise
synaptic vesicles
storing neurotransmitters. The axonal terminals are specialized to release the
neurotransmitters into
an interface or junction between the axon and the muscle cell. The released
neurotransmitter binds
to a receptor on the cell membrane of the muscle cell for a short period of
time before it is
dissociated and hydrolyzed by an enzyme located in the synapse. This enzyme
quickly reduces the
stimulus to the muscle, which allows the degree and timing of muscular
contraction to be regulated
delicately.
The action potential in a normal skeletal muscle cell is similar to the action
potential in
neurons and is typically about -90 mV. Upon activation, the intrinsic
sodium/potassium channel of
the cell membrane is opened, causing sodium to rush in and potassium to
trickle out. As a result,
the cell membrane reverses polarity and its voltage quickly jumps from the
resting membrane
potential of -90 mV to as high as +75 mV as sodium enters. The muscle action
potential lasts
roughly 2-4 ms, the absolute refractory period is roughly 1-3 ms, and the
conduction velocity along
the muscle is roughly 5 m/s. This change in polarity causes in turn the muscle
cell to contract.
The contraction and relaxation of smooth muscle cells is typically influenced
by multiple
inputs such as spontaneous electrical activity, neural and hormonal inputs,
local changes in
chemical composition, and stretch. This in contrast to the contractile
activity of skeletal and cardiac
muscle cells, which may rely on a single neural input. Some types of smooth
muscle cells are able
to generate their own action potentials spontaneously, which usually occur
following a pacemaker
potential or a slow wave potential. However, the rate and strength of the
contractions can be
modulated by external input from the autonomic nervous system. Autonomic
neurons may
comprise a series of axon-like swellings, called varicosities, forming motor
units through the
smooth muscle tissue. The varicosities comprise vesicles with
neurotransmitters for transmitting
the signal to the muscle cell. The autonomic neurons may for example trigger a
muscular response
in the wall of the renal artery, leading to a contraction or relaxation
affecting a flow resistance in
the renal artery. Sympathetic stimulation (norepinephrine) has been observed
to constrict some
blood vessels and dilate others, depending on whether the target cells (i.e.,
the smooth muscle cells)
has alpha- or beta-adrenergic receptors. The sympathetic nervous system can
also constrict or dilate
vessels just by changing firing frequency of the action potentials. An
increased firing frequency
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may cause the smooth muscle to contract and constrict the vessel, whereas a
reduced firing
frequency may cause the smooth muscle cells to relax, allowing blood pressure
to dilate the vessel.
The muscle cells described above, i.e., the cardiac, skeletal and smooth
muscle cells are
known to react to external stimuli, such as electrical stimuli applied by
electrodes. A distinction can
be made between stimulation transmitted by a nerve and direct electrical
stimulation of the muscle
tissue. In case of stimulation via a nerve, an electrical signal may be
provided to the nerve at a
location distant from the actual muscle tissue, or at the muscle tissue,
depending on the
accessibility and extension of the nerve in the body. The stimulation devices
110, 120 as well as the
signal damping devices described above in connection with for instance figures
4-7 may employ
both a direct stimulation of the muscle tissue and stimulation transmitted via
a nerve to affect the
vasomotor tone.
In case of direct stimulation of the muscle tissue, the electrical signal may
be provided to
the muscle cells by an electrode arranged in direct or close contact with the
cells of the renal artery
20. However, other tissue such as fibrous tissue and nerves may of course be
present at the
interface between the electrode and the muscle tissue, which may result in the
other tissue being
subject to the electrical stimulation as well.
In the context of the present application, the electrical stimulation
discussed in connection
with the various aspects and embodiments may be provided to the tissue in
direct or indirect
contact with the implantable medical device. Preferably, the electrical
stimulation is provided by
one or several electrode elements arranged at the interface or contact surface
between the
implantable constriction device and the tissue. Thus, the electrical
stimulation for exercising the
tissue may, in terms of the present disclosure, be considered as a direct
stimulation of the tissue.
Particularly when contrasted to stimulation transmitted over a distance by a
nerve, which may be
referred to as an indirect stimulation or nerve stimulation.
In the following, the interaction between an implanted electrode element and
tissue of the
body will be discussed. This discussion may be applied both to electrical
stimulation for inducing
vasodilation of the renal artery 20 as well as signal damping, electric
sensing and electrical
stimulation for exercising the tissue to reduce effects of deterioration
caused by presence of a long
term implanted medical device.
It has been observed that the interaction between an implanted electrode
element and tissue
of the body is to a large extent determined by the properties at the junction
between the tissue and
the electrode element. The active electrically conducting surface of the
electrode element (in the
following referred to as "metal", even though other materials is equally
conceivable) can either be
uncoated resulting in a metal¨tissue interface (such as disclosed in figure
9c), or insulated with
some type of dielectric material (such as disclosed in figure 9d). The
uncoated metal surface of the
electrode element may also be referred to as a bare electrode. The interface
between the electrode
element and the tissue may influence the behavior of the electrode element,
since the electrical
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interaction with the tissue is transmitted via this interface. In the
biological medium surrounding
the electrode element, such as the actual tissue and any electrolyte that may
be present in the
junction, the current is carried by charged ions, while in the material of the
electrode element the
current is carried by electrons. Thus, in order for a continuous current to
flow, there needs to be
some type of mechanism to transfer charge between these two carriers.
In some examples, the electrode element may be a bare electrode wherein the
metal may be
exposed to the surrounding biological medium when implanted in, or at the
muscle tissue that is to
be stimulated. In this case there may be a charge transfer at a
metal¨electrolyte interface between
the electrode element and the tissue. Due to the natural strive for
thermodynamic equilibrium
between the metal and the electrolyte, a voltage may be established across the
interface which in
turn may cause an attraction and ordering of ions from the electrolyte. This
layer of charged ions at
the metal surface may be referred to as a "double layer" and may physically
account for some of
the electrode capacitance.
Hence, both capacitive faradaic processes may take place at the electrode
element. In a
faradaic process, a transfer of charged particles across the metal¨electrolyte
interface may be
considered as the predominant current transfer mechanism. Thus, in a faradaic
process, after
applying a constant current, the electrode charge, voltage and composition
tend to go to constant
values. Instead, in a capacitive (non-faradaic) process charge is
progressively stored at the metal
surface and the current transfer is generally limited to the amount which can
be passed by charging
the interface.
In some examples, the electrode element may comprise a bare electrode portion,
i.e., an
electrode having an uncoated surface portion facing the tissue such that a
conductor¨tissue
interface is provided between the electrode element and the tissue when the
electrode element is
implanted. This allows for the electric signal to be transmitted to the tissue
by means of a
predominantly faradaic charge transfer process. A bare electrode may be
advantageous from a
power consumption perspective, since a faradaic process tend to be more
efficient than a capacitive
charge transfer process. Hence, a bare electrode may be used to increase the
current transferred to
the tissue for a given power consumption.
In some examples, the electrode element may comprise a portion that is at
least partly
covered by a dielectric material so as to form a dielectric-tissue interface
with the muscle tissue
when the electrode is implanted. This type of electrode element allows for a
predominantly
capacitive, or non-faradaic, transfer of the electric signal to the muscle
tissue. This may be
advantageous over the predominantly faradaic process associated with bare
electrodes, since
faradaic charge transfer may be associated with several problems. Example of
problems associated
with faradaic charge transfer include undesirable chemical reactions such as
metal oxidation,
electrolysis of water, oxidation of saline, and oxidation of organics.
Electrolysis of water may be
damaging since it produces gases. Oxidation of saline can produce many
different compounds,
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some of which are toxic. Oxidation of the metal may release metal ions and
salts into the tissue
which may be dangerous. Finally, oxidation of organics in a situation with an
electrode element
directly stimulating tissue may generate chemical products that are toxic.
These problems may be alleviated if the charge transfer by faradaic mechanisms
is reduced,
which may be achieved by using an electrode at least partly covered by a
dielectric material.
Preferably, the dielectric material is chosen to have as high capacitance as
possible, restricting the
currents flowing through the interface to a predominantly capacitive nature.
Several types of electrode elements can be combined with the present
disclosure. The
electrode element can for example be a plate electrode as indicated in figure
9a, comprising a plate-
shaped active part forming the interface with the tissue. In other examples,
the electrode may be a
wire electrode as indicated in figure 9b, formed of a conducting wire that can
be brought in
electrical contact with the tissue. Further examples may include needle- or
pin-shaped electrodes as
indicated in figure 8c and d, having a point at the end which can be attached
to or inserted in the
muscle tissue. The electrodes may for example be encased in epoxy for
electrical isolation and
protection and comprise gold wires or contact pads for contacting the muscle
tissue.
Preferably, the electrode may be arranged to transmit the electrical signal to
the portions of
the tissue that is affected, or risks to be affected, by mechanical forces
exerted by the medical
implant. Thus, the electrode element may be considered to be arranged between
the implanted
device and the tissue against which the device is arranged to rest when
implanted.
During operation of the medical device, or the electrode arrangement, the
electric signal
may cause the muscle cells to contract and relax repeatedly. This action of
the cells may be referred
to as exercise and may have a positive impact in terms of preventing
deterioration and damage of
the tissue. Further, the exercise may help increasing tolerance of the tissue
for pressure and
mechanical forces generated by the medical implant. The extent or amplitude of
the contraction
may however be reduced to a level which do not risk to substantially affect
the flow resistance in
the renal artery 20. The contraction and relaxation induced for exercising
purposes may thus be less
than the vasodilation induced for the purpose of affecting the blood pressure.
Alternatively, or
additionally the exercise may involve contraction and relaxation at a
relatively high frequency,
hindering the blood vessel to contract to a degree that affects the vascular
resistance in the vessel
before it is relaxed again.
The electrical signal for exercising the tissue may be generated by a
controller, such as the
control unit 150 discussed above in connection with figure 11. The controller
150 may be
configured to control the electrical stimulation such that the tissue is
stimulated by a series of
electrical pulses. The pulses may comprise a pulse of a first polarity
followed by a pulse of a
second, reversed polarity, and the pulsed electrical stimulation signal
generated comprises a pulse
frequency of 0.01-150 Hz. In an example, the electrical stimulation signal
comprises a pulse
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duration of 0.01-100 ms and a pulse amplitude of 1-15 mA. Example
characteristics of electric
signals for exercising the tissue is discussed below with reference to figures
15 and 16.
The controller may be configured to receive input from a wireless remote
control, directly
or via a receiver of the implantable controller, for controlling the
stimulation or for programming a
5 stimulation routine for exercising the muscle tissue to improve the
conditions for long term
implantation of the implantable medical device. The programming of a
stimulation routine could
for example be the programming of the frequency of the stimulation, or the
current and/or voltage
of the stimulation.
It will be appreciated that both faradaic and capacitive mechanisms may be
present at the
10 same time, irrespectively of the type of electrode used and the type of
stimulation provided (i.e., for
the purpose of vasoconstriction/vasodilation, signal damping, or for the
purpose of exercising the
tissue). Thus, capacitive charge transfer may be present also for a bare
electrode forming a metal¨
tissue interface, and faradaic charge transfer may be present also for a
coated electrode forming a
dielectric¨tissue interface. It has been found that the faradaic portion of
the current delivered to the
15 muscle tissue can be reduced or even eliminated by reducing the duration
of the pulses of the
electric signal. Reducing the pulse duration has turned out to be an efficient
way of increasing the
portion of the signal which can be passed through the interface as a
capacitive current, rather than
by a faradaic current. As a result, shorter pulses may produce less electrode
and tissue damage.
The capacitive portion of the current may further be increased, relative to
the faradaic
20 portion, by reducing the amplitude of the current pulses of the
electrical signal. Reducing the
current may reduce or suppress the chemical reactions at the interface between
the electrode and
the tissue, thereby reducing potential damage that may be caused by compounds
and ions generated
by such reactions.
In one example, the electrical stimulation may be controlled in such a manner
that a
25 positive pulse of the electrical signal is followed by a negative pulse
(or, put differently, a pulse of
a first polarity being followed by a pulse of a second, reversed polarity),
preferably of the same
amplitude and/or duration. Advantageously, the subsequent negative (or
reversed) pulse may be
used to reverse or at least moderate chemical reactions or changes taking
place in the interface in
response to the first, positive pulse. By generating a reversed pulse, the
risk of deterioration of the
30 electrode and/or the tissue at the interface between the electrode and
the muscle tissue may be
reduced.
Figure 15 shows an example of a pulsed electrical signal to be applied to an
electrode for
electrically stimulating muscle tissue via an electrode-tissue interface,
thereby exercising the
muscle tissue, as discussed above. The electrical signal may be generated by a
controller arranged
35 outside the body or implanted in the body (as described with reference
to figure 11). The
characteristics of the electrical signal may be selected and varied determined
on the electrical and
properties at the electrode¨tissue interface and on the actual response of the
tissue. The electrical
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stimulation delivered to the muscle cells may depend on several factors, such
as the configuration
and placement of the electrode element at the tissue, the presence of fibrous
material at the
interface, the composition of the electrolyte in the interface, accumulation
of non-conducting
material on the electrode surfaces, etcetera. It is therefore suggested that
the characteristics of the
electric signal, as shown in the present figure, be selected and varied based
on an observed or
estimated response from the stimulated tissue.
In the present example, the electrical signal is a pulsed signal comprising
square waves
PL1, PL2, PL3, PL4. However, other shapes of the pulses may be employed as
well. The pulse
signal may be periodic, as shown, or may be intermittent (i.e., multiple
series of pulses separated
by periods of no pulses). The pulses may have an amplitude A, which may be
measured in volts,
ampere or the like. Each of the pulses of the signal may have a pulse width D.
Likewise, if the
signal is periodic, the pulse signal may have a period F that corresponds to a
frequency of the
signal. Further, the pulses may be either positive or negative in relation to
a reference.
The pulse frequency may for example lie within the range of 0.01-150 hertz.
More
specifically, the pulse frequency may lie within at least one of the ranges of
0.1-1 Hz, 1-10 Hz, 10-
50 Hz and 50-150 Hz. It has been observed that relatively low pulse
frequencies may be employed
to imitate or enhance the slow wave potential associated with pacemaker cells
of the smooth
muscle tissue. Thus, it may be advantageous to use relatively low pulse
frequencies, such as 0.01-
0.1 Hz or frequencies below 1 Hz or a few Hz for such applications.
The pulse duration may for example lie within the range of 0.01-100
milliseconds, such as
0.1-20 milliseconds (ms), and preferably such as 1-5 ms. The natural muscle
action potential has in
some studies been observed to last about 2-4 ms, so it may be advantageous to
use a pulse duration
imitating that range.
The amplitude may for example lie within the range of 1-15 milliamperes (mA),
such as
0.5-5 mA in which range a particularly good muscle contraction response has
been observed in
some studies.
In a preferred, specific example the electrical stimulation may hence be
performed using a
pulsed signal having a pulse frequency of 10 Hz, a pulse duration of 3 ms and
an amplitude of 3
mA.
Fig. 16 shows an example of a pulsed signal, comprising build-up period Xl, in
which the
amplitude is gradually increasing, a stimulation period X2 during which the
muscle tissue is
exposed to a contracting stimulation signal, a ramp down period X3 in which
the amplitude is
gradually decreasing, and a stimulation pause X4 before a new build-up period
is initiated. The
build-up period may for example be 0.01-2 seconds, the stimulation period 1-60
seconds, the ramp-
down period 0.01-2 seconds, and the stimulation pause 0.01-60 seconds. The
pulse frequency may
for example be 1-50 Hz, the pulse duration 0.1-10 milliseconds and the
amplitude during the
stimulation period be 1-15 milliampere. The stimulation of skeletal muscle
tissue may for example
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be performed using a frequency of 50 Hz and pulses having a duration of 100
ts. The current
amplitude may be 1, 2.5, 7.5 or 10 mA. In particular, a desired muscle
contraction response has
been experimentally observed within a range of 0.5 to 5.0 mA. In the present
example, a coiled
electrode may be used as a cathode. Another example design is a multi-stranded
wire arranged in a
helical design. They can be imbricated in the muscular wall of the luminary
organ, such as the renal
artery 20, and can be stimulated in any desired pattern. The stimulus
parameters may for example
be biphasic pulses, 10 to 40 Hz, lasting 0.1 to 5 ms, with a current density
of 3 to 5 mA/cm2.
Techniques for mitigating fibrin creation caused by the contact between the
medical
implant and the tissue or flowing blood of a patient, will now be described
with reference to figures
18-21. By "medical implant", or "implantable medical device" as referred to in
the following is
understood any of the devices discussed above in connection with figures 1-17.
Thus, the below
described coatings for mitigating fibrin creation may be implemented in a
stimulation device 110 as
disclosed in figures 4, 5, 6, 8 a signal damping device 120 as disclosed in
figure 6, 7, 8, and a
sensor as disclosed in figures 12a-d, 13 and 14, other element or part of the
systems for treating a
patient suffering from hypertension as disclosed herein.
All foreign matter implanted into the human body inevitably causes an
inflammatory
response. In short, the process starts with the implanted medical device
immediately and
spontaneously acquiring a layer of host proteins. The blood protein-modified
surface enables cells
to attach to the surface enabling monocytes and macrophages to interact on the
surface of the
medical implant. The macrophages secrete proteins that modulate fibrosis and
in turn developing
the fibrosis capsule around the foreign body. In practice, a fibrosis capsule
is a dense layer of
excess fibrous connective tissue. On a medical device implanted in the
abdomen, the fibrotic
capsule typically grows to a thickness of about 0,5mm ¨ 2mm, and is
substantially inelastic and
dense.
The body tends to react to a medical implant, partly because the implant is a
foreign object,
and partly because the implant interacts mechanically with tissue of the body
and/or blood flowing
within the body. Implantation of medical devices and or biomaterial in the
tissue of a patient may
trigger the body's foreign body reaction (FBR). FBR leads to a formation of
foreign body giant
cells and the development of a fibrous capsule enveloping the implant. The
formation of a dense
fibrous capsule that isolates the implant from the host is the common
underlying cause of implant
failure. Implantation of medical devices and or biomaterial in a blood flow
may also cause the
formation of fibrous capsules due to the attraction of certain cells within
the blood stream.
Implants may, due to the fibrin formation cause blood clotting leading to
complications for
the patient. Implants in contact with flowing blood and/or placed in the body
may also lead to
bacterial infection.
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One common way of counteracting the creation of blood clots is by using blood
thinners of
different sorts. One commonly used blood thinner is called heparin. However,
heparin have certain
side-effects that are undesirable.
Fibrin is an insoluble protein that is partly produced in response to bleeding
and is the
major component of blood clots. Fibrin is formed by fibrinogen, a soluble
protein that is produced
by the liver and found in blood plasma. When tissue damage results in
bleeding, fibrinogen is
converted at the wound into fibrin by the action of thrombin, a clotting
enzyme. The fibrin then
forms, together with platelets, a hemostatic plug or clot over a wound site.
The process of forming fibrin from fibrinogen starts with the attraction of
platelets.
Platelets have thrombin receptors on their surfaces that bind serum thrombin
molecules. These
molecules can in turn convert soluble fibrinogen into fibrin. The fibrin then
forms long strands of
tough and insoluble protein bound to the platelets. The strands of fibrin are
then cross-linked so
that it hardens and contracts, this is enabled by Factor XIII which is a
zymogen found in the blood
of humans.
Figures 17a-c describes the reaction that takes place when a blood vessel is
damaged. A
blood vessel 700 is damaged and wound 710 appears. The blood contains many
different cells and
particles, for example red blood cells 720 and platelets 730. When the wound
710 appears red
blood cells 720 and platelets 730 start to gather at the wound 710. Due to the
thrombin receptors on
the surface of the platelets 730 a fibrin sheath 740 starts to form which
eventually creates a clot that
stops the bleeding.
Fibrin may also be created due to the foreign body reaction. When a foreign
body is
detected in the body the immune system will become attracted to the foreign
material and attempt
to degrade it. If this degradation fails, an envelope of fibroblasts may be
created to form a physical
barrier to isolate the body from the foreign body. This may further evolve
into a fibrin sheath, in
case the foreign body is an implant this may hinder the function of the
implant.
Implants can, when implanted in the body, be in contact with flowing blood.
This may
cause platelet adhesion on the surface of the implants. The platelets may then
cause the fibrinogen
in the blood to convert into fibrin creating a sheath on and or around the
implant. This may prevent
the implant from working properly and may also create blood clots that are
perilous for the patient.
The probe 142 of the sensor 140 in figure 12a is an example of an implant that
is in contact with
flowing blood when implanted in the body.
Implants not in contact with flowing blood can still malfunction due to fibrin
creation. Here
the foreign body reaction may be the underlying factor for the malfunction.
Further, the
implantation of a foreign body into the human body may cause an inflammatory
response. The
response generally persists until the foreign body has been encapsulated in a
relatively dense layer
of fibrotic connective tissue, which protects the human body from the foreign
body. The process
may start with the implant immediately and spontaneously acquiring a layer of
host proteins. The
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blood protein-modified surface enables cells to attach to the surface,
enabling monocytes and
macrophages to interact on the surface of the implant. The macrophages secrete
proteins that
modulate fibrosis and in turn develop the fibrosis capsule around the foreign
body, i.e., the implant.
In practice, a fibrosis capsule may be formed of a dense layer of excess
fibrous connective tissue.
The inelastic properties of the fibrotic capsule may lead to hardening,
tightness, deformity, and
distortion of the implant, which in severe cases may result in revision
surgery.
Any implant that is implanted into the body may trigger the formation of
fibrin sheaths.
One example of an implant that may trigger the formation of fibrin sheaths is
the probe 142 of the
sensor 140 shown in figure 12a, which now will be described as an example in
relation to figures
18-19d. However, the probe 142 may be any implantable medical device either in
contact with
flowing blood or not in contact with flowing blood.
The sensor 140 may be placed in a blood vessel, such as the renal artery or
another blood
vessel, to measure a pressure and/or blood flow in the vessel. On the surface
of the part of the
sensor 140 arranged in the blood flow, indicated by reference numeral 100 in
the present figures,
blood clots may form. This risk arises from the sensor 100 being in contact
with flowing blood and
may also be due to the trauma caused to the vein when placing the CVK. Figure
18 shows an
implant 100 being a sensor 140 placed inside a blood vessel 700 with a fibrin
sheath 740 that has
formed on and around part of the sensor 10. The sheath 740 may cause the
implant 100 to
malfunction and may further create a blood clot that may be harmful for the
patient. The formation
of a blood clot may have several steps, as depicted in figures 19a-19d. Figure
19a shows a fibrin
sheath 740 created on a sensor probe 140 inside a blood vessel 700, such as
the renal artery 20
shown in figure 14. In Figure 19b the sheath has further developed into an
intraluminal clot 740. In
Figure 19c the clot has connected to one side of the vessel creating a mural
thrombosis 740. And in
Figure 19d the clot has reached a thrombosis 740.
As mentioned, the sensor probe 140 is used as an example. A fibrin sheath 740
may be
created on any implantable medical device 100 and may then cover certain
necessary part of the
device 100 inhibiting the function of the device 10.
Implants or biomaterials that are inserted into the body may also cause
infections of
different sorts. Bacterial colonization that leads to implant-associated
infections are a known issue
for many types of implants. For example, the commensal skin bacteria,
Staphylococci, and the
Staphylococcus aureus tend to colonize foreign bodies such as implants and may
cause infections.
A problem with the Staphylococci is that it may also produce a biofilm around
the implant
encapsulating the bacterial niche from the outside environment. This makes it
harder for the host
defense systems to take care of the bacteria. There are other examples of
bacteria and processes
that creates bacteria causing infection due to implants.
Figure 20 shows an implantable medical device or implant 100 comprising an
implant
surface 750 and a coating 760 arranged on the surface 750 . The coating 760
may be configured to
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have antibacterial and/or antithrombotic characteristics. Depending on the use
of the implantable
medical device one or both of these effects may be advantageous. The coating
760 may be arranged
on the surface 750 so that the coating shields the surface 750 from direct
contact with the host body
where the implantable medical device 100 is inserted.
5 The implantable medical device 100 may for example be an element or part
of a system for
treating hypertension, such as a stimulation device 110 shown in figures 4-6
and 11, a signal
damping device 120 shown in figures 6,7 and 11, and a sensor 140 shown in
figures 11-14. The
coating 760 may then be placed on surfaces of any of these devices, preferably
facing the renal
artery or elsewhere, or being in contact with the blood flow (such as the
sensor 140 when arranged
10 inside the blood vessel).
The coating 760 may comprise at least one layer of a biomaterial. The coating
760 may
comprise a material that is antithrombotic. The coating 760 may also comprise
a material that is
antibacterial. The coating 760 may be attached chemically to the surface 750.
Figure 21 shows an exemplary implantable medical device or implant 100
comprising an at
15 least partially hollow implant body 100. The body 100 may for example
form the probe 142 of the
sensor 140 shown in figure 12a, or a holding structure such as the cuff shown
in figures 5-7 or 13a-
b. Since multiple surfaces of the implant 100 may be in contact with flowing
blood it may comprise
a first coating 760a and a second coating 760b. The coatings 760a and 760b may
be similar or have
different properties. Depending on how the implant 100 is placed the coatings
760a and 760b may
20 come into contact with different parts or liquids within the body and
may therefore comprise either
similar materials or materials with different properties. Alternatively, when
arranged on the outside
of for instance the renal artery, the inner surface may abut the outer wall of
the renal artery whereas
the outer surface may come in contact with surrounding tissue at the renal
artery.
Figure 22 shows an exemplary implantable medical device or implant 100 with a
surface
25 750. The implantable medical device 100 comprises multiple coatings,
760a, 760b, 760c arranged
on the surface. The implant 100 may comprise any number of coatings, the
particular embodiment
of Figure 22 discloses three layers of coating 760a, 760b, 760c. The second
coating 760b is
arranged on the first coating 760a. The different coating 760a, 760b, 760c may
comprise different
materials with different features to prevent either fibrin sheath formation or
bacteria gathering at
30 the surface 750. As an example, the first coating 760a may comprise a
layer of perfluorocarbon
chemically attached to the surface. The second coating 760b may comprise a
liquid
perfluorocarbon layer arranged on the first coating 760a. Perfluorocarbon is
used in medicine
application in a variety of fields and may be advantageous for using as a
coating layer.
The coatings may comprise any type of substance with antithrombotic,
antiplatelet or
35 antibacterial features. Such substances include sortase A,
perfluorocarbon and more.
The coatings presented in relation to the figures may also be combined with an
implantable
medical device comprising certain materials that are antibacterial or
antithrombotic. For example,
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some metals have shown to be antibacterial. In case the implant, or at least
the surfaces of the
implant, are made out of such a metal it may be advantageous in order to
reduce bacterial
infections. The medical implant or the surface of the implant may be made out
of any other suitable
metal or material. The surface may for example comprise any of the following
metals, or any
combination of the following metals: titanium, cobalt, nickel, copper, zinc,
zirconium,
molybdenum, tin or lead.
An implantable medical device can also be coated with a slow releasing anti-
fibrotic or
antibacterial drug in order to prevent fibrin sheath creation and bacterial
inflammation. The drug or
medicament may be coated on the surface and be arranged to slowly be released
from the implant
in order to prevent the creation of fibrin or inflammation. The drug may also
be covered in a porous
or soluble material that slowly disintegrates in order to allow the drug to be
administered into the
body and prevent the creation of fibrin. The drug may be any conventional anti-
fibrotic or
antibacterial drug.
Figure 23a and 23b shows different micropatterns on the surface 750 of an
implant. In
order to improve tissue or blood compatibility, the implant materials physical
structure may be
altered or controlled. By creating a certain topography on the surface 750 of
an implant fibrin
creation and inflammatory reactions may be inhibited. Figure 23a is an example
of a micropattern
that mimics the features of sharkskin. The micropattern may have many
different shapes, many
different indentation or recess depths into the surface 750 of the implant 100
and may be a
complement to other coatings or be used individually. In Figure 23b another
example of a
micropattern is disclosed.
The micropattern may for example be imprinted or etched into the surface 750
of the
implantable medical device 100 prior to insertion into the body. The surface
of the implantable
medical device 100 may for example comprise a metal. This may for instance be
case for the
electrode elements of the stimulation device 110 and the signal damping device
120. The surface
may for example comprise any of the following metals, or any combination of
the following
metals: titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin or
lead. This may be
advantageous in that these metals have proven to be antibacterial which may
ensure that the
implant functions better when inserted into the host body.
As mentioned above, the system may comprise an energy source for providing the
energy
required to energize the electrode arrangement and thereby allow the renal
artery to be stimulated
by the electrical stimulation signal. Figure 24a shows an illustrating example
of a system
comprising an implantable energy receiver 241 configured to energize the
electrode arrangement,
as well as an energy source 242 configured to transfer energy wirelessly to
the energy receiver 241.
The system may be similarly configured as any of the above-mentioned systems
for treating a
patient suffering from hypertension, such as the system disclosed in any of
figures 4-8 or 11.
Hence, figure 24a shows a renal artery 20, to which a stimulation device 110
comprising an
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electrode arrangement 112a, 122a operable to affect a vasomotor tone in the
renal artery 20, has
been attached. The stimulation device 110 may comprise a plurality of
contacting portions 112a,
122a', or electrode elements, configured to mechanically engage, or be
arranged to rest against,
tissue of an outer wall of a portion of the renal artery 20 to transmit the
electrical stimulation signal
to the tissue. The electrode elements 122a, 122a' may be arranged on an inner
surface of a cuff
portion 126, similar to the one shown in figure 5, or be attached directly
onto the outer wall. In
some embodiments, some of the electrode elements 122a, 122a' may be configured
to deliver a
damping signal, as outlined above, to hinder the stimulation signal from
propagating to part of the
body in which it is not desired to deliver the stimulation signal. Further, as
illustrated in figure 24a,
the system may comprise a control unit which is operably connected to the
stimulation device 110
and configured to control an operation of the stimulation device 110 such that
the electric
stimulation signal (and, optionally, the damping signal) delivered by the
electrode arrangement
112a, 122a' causes the desired vasodilation.
The energy receiver 241, which for example may comprise a coil arrangement
configured
to receive energy inductively, may be implanted in the body of the patient. In
the present example
in figure 24a, an energy receiver 241 may be integrated in one or both of the
control units 114, 124.
However, other arrangements are also possible, in which the energy receiver
241 for example is
arranged as a separate element that can be implanted at a different location
than the control unit(s)
114, 124. In the latter case, the received energy may be transmitted to the
control units(s) 114, 124
or electrode arrangement 112a, 122a' by a wired connection extending between
the energy receiver
241 and the control unit/electrode arrangement.
The energy source 242 may be implantable in the body or arranged outside the
body.
Similar to the energy receiver 241, the energy source 242 may be configured to
be operated on an
inductive basis, in which the energy is transferred from the energy source 242
to the energy
receiver 241 wirelessly. Hence, the energy source may comprise a coil
arrangement enabling the
inductive coupling to the energy receiver 241. It will be appreciated that the
energy source 242
further may comprise an energy storage, such as a primary or secondary cell,
for storing electrical
energy for transfer upon request. In case the energy source 242 is implanted
in the body, a non-
rechargeable battery may require a surgical procedure for replacement, whereas
a rechargeable
battery may be recharged wirelessly/inductively from a charging source
arranged outside the body.
Beneficially, the latter allows the energy source 242 to be recharged without
requiring any surgical
procedures.
Additionally, or alternatively, the system may comprise a control unit which
is configured
to transmit the control instructions wirelessly to the stimulation device 110.
The control unit may
comprise an external part 242 configured to be arrange outside the body of the
patient, and an
internal part 241 configured to be implanted in the patient. The internal part
241 and the external
part 242 may be configured to communicate wirelessly with each other, for
example by means of
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radiofrequency signals or inductive signals. It will be appreciated that the
internal part 241 as well
as the external part 242 shown in figure 24a may form a control unit similar
to what has been
described above in connection with previous embodiments, and that they in some
embodiments
may be structurally integrated in the above described energy receiver 241 and
energy source 242.
The wireless transmission of data from the internal external part 241 to the
external parts 242 may,
for instance, relate to sensor values indicating functional or status
parameters of the implant or the
patient. Examples of such parameters may for example include temperature of an
implanted energy
source, or another part of the implanted system or the body of the patient.
Further examples include
information indicating a vasodilation of the renal artery, a blood pressure of
the patient, or a
nervous reaction triggered by the electric stimulation signal provided by the
stimulation device 110.
The internal and external parts 241, 242 may further be configured to transmit
data relating to a
status of an implanted energy source of the system, such as charging capacity,
charge status, and
the like.
As mentioned in connection with for instance figure 24a and figure 11, a
controller, or
control unit 140, may be provided for controlling the implantable device. The
control may require
transmission of data, such as sensor values, operational parameters and ditto
instructions, to and/or
from the implanted devices and functions. In the following, various aspects
and examples of such
communication will be discussed. Functions and effects of such a controller
will now be described
with reference to figures 24a ¨ 24f. The features of the controller described
with reference to
figures 24a ¨ 24f may be implemented and combined with any of the embodiments
of implantable
devices disclosed herein. The features may for example be implemented in, or
combined with, the
stimulation devices 110 shown in figures 4-6, 8 and 11, the signal damping
devices 120, 160 shown
in figures 6-8 and 11, and the sensor 140 shown in figures 13a-b.
A controller, such as the control units shown in the previous figures, may
comprise an
internal computing unit, also called a processor. The controller may also
comprise a
communication unit and circuitry for executing communication functions,
including verification,
authentication and encryption of data, as described in the following.
The controller may comprise a collection of communication related sub-units
such as a
wired transceiver, a wireless transceiver, energy storage unit, an energy
receiver, a computing unit,
a memory, or a feedback unit. The sub-units of the controller may cooperate
with each other or
operate independently with different purposes. The sub-units of the controller
may inherit the
prefix "internal". This is to distinguish these sub-units from the sub-units
of the external devices as
similar sub-units may be present for both the implanted controller and the
external devices. The
sub-units of the external devices may similarly inherit the prefix "external".
A wireless transceiver may comprise both a wireless transmitter and a wireless
receiver.
The wireless transceiver may also comprise a first wireless transceiver and a
second wireless
transceiver. In this case, the wireless transceiver may be part of a first
communication system
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(using the first wireless transceiver) and a second communication system
(using the second
wireless transceiver).
In some embodiments, two communication systems may be implemented using a
single
wireless transceiver in e.g. the implant and a single wireless transceiver in
e.g. an external device
(i.e. one antenna at the implant and one antenna at the external device), but
where for example the
network protocol used for data transmission from the external device to the
implant is different
from the network protocol used for data transmission from the implant to the
external device, thus
achieving two separate communication systems.
Alternatively, the wireless transceiver may be referred to as either a
wireless transmitter or
a wireless receiver as not all embodiments of secure wireless communication
discussed herein
require two-way communication capability of the wireless transceiver. The
wireless transceiver
may transmit or receive wireless communication via wireless connections. The
wireless transceiver
may connect to both the implant and to external devices, i.e. devices not
implanted in the patient.
The wireless connections may be based on radio frequency identification
(RFID), near field
charge (NFC), Bluetooth, Bluetooth low energy (BLE), or wireless local area
network (WLAN).
The wireless connections may further be based on mobile telecommunication
regimes such as 1G,
2G, 3G, 4G, or 5G. The wireless connections may further be based on modulation
techniques such
as amplitude modulation (AM), frequency modulation (FM), phase modulation
(PM), or quadrature
amplitude modulation (QAM). The wireless connection may further feature
technologies such as
time-division multiple access (TDMA), frequency-division multiple access
(FDMA), or code-
division multiple access (CDMA). The wireless connection may also be based on
infra-red (IR)
communication. The wireless connection may feature radio frequencies in the
high frequency band
(HF), very-high frequency band (VHF), and the ultra-high frequency band (UHF)
as well as
essentially any other applicable band for electromagnetic wave communication.
The wireless
connection may also be based on ultrasound communication to name at least one
example that does
not rely on electromagnetic waves.
A wired transceiver may comprise both a wired transmitter and a wired
receiver. The
wording wired transceiver aims to distinguish between it and the wireless
transceiver. It may
generally be considered a conductive transceiver. The wired transceiver may
transmit or receive
conductive communication via conductive connections. Conductive connections
may alternatively
be referred to as electrical connections or as wired connections. The wording
wired however, does
not imply there needs to be a physical wire for conducting the communication.
The body tissue of
the patient may be considered as the wire. Conductive connection may use the
body of the patient
as a conductor. Conductive connections may still use ohmic conductors such as
metals to at least
some extent, and more specifically at the interface between the wired
transceiver and the chosen
conductor.
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Communication, conductive or wireless may be understood as digital or
analogue. In
analogue communication, the message signal is in analogue form i.e., a
continuous time signal. In
digital communication, usually digital data i.e., discrete time signals
containing information is
transmitted.
5 The controller may comprise a sensation generator. A sensation generator
is a device or
unit that generates a sensation. The sensation generated may be configured to
be experienceable by
the patient such that the patient may take actions to authenticate a device,
connection or
communication. The sensation generator may be configured to generate a single
sensation or a
plurality of sensation components. The sensation or sensation components may
comprise a
10 vibration (e.g., a fixed frequency mechanical vibration), a sound (e.g.,
a superposition of fixed
frequency mechanical vibrations), a photonic signal (e.g., a non-visible light
pulse such as an infra-
red pulse), a light signal (e.g., a visual light pulse), an electric signal
(e.g., an electrical current
pulse) or a heat signal (e.g., a thermal pulse). The sensation generator may
be implanted,
configured to be worn in contact with the skin of the patient or capable of
creating sensation
15 without being in physical contact with the patient, such as a beeping
alarm.
The sensations generated by the sensation generator may be configured to be
experienceable by a sensory function or a sense of the patient from the list
of tactile, pressure, pain,
heat, cold, taste, smell, sight, and hearing. Sensations may be generated of
varying power or force
as to adapt to sensory variations in the patient. Power or force may be
increased gradually until the
20 patient is able to experience the sensation. Variations in power or
force may be controlled via
feedback. Sensation strength or force may be configured to stay within safety
margins. The
sensation generator may be connected to the implant. The sensation generator
may be comprised
within the implant or be a separate unit.
A motor, e.g. of the active device or unit of the implant, for controlling a
physical function
25 in the body of the patient may provide a secondary function as a
sensation generator, generating a
vibration or sound. Generation of vibrations or sounds of the motor may be
achieved by operating
the motor at specific frequencies. When functioning as to generate a sensation
the motor may
operate outside of its normal ranges for frequency controlling a physical
function in the body. The
power or force of the motor when operating to generate a sensation may also
vary from its normal
30 ranges for controlling a physical function in the body.
An external device is a device which is external to the patient in which the
implant is
implanted in. The external device may be also be enumerated (first, second,
third, etc.) to separate
different external devices from each other. Two or more external devices may
be connected by
means of a wired or wireless communication as described above, for example
through IP (internet
35 protocol), or a local area network (LAN). The wired or wireless
communication may take place
using a standard network protocol such as any suitable IP protocol (IPv4,
IPv6) or Wireless Local
Area Network (IEEE 802.11), Bluetooth, NFC, RFID etc. The wired or wireless
communication
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may take place using a proprietary network protocol. Any external device may
also be in
communication with the implant using wired or wireless communication according
to the above.
Communication with implanted devices may be thus accomplished with a wired
connection or with
wireless radiofrequency (RF) telemetry. Other methods of wireless
communication may be used to
communicate with implants, including optical and ultrasound. Alternatively,
the concept of
intrabody communication may be used for wireless communication, which uses the
conductive
properties of the body to transmit signals, i.e., conductive (capacitive or
galvanic) communication
with the implant. Means for conductive communication between an external
device and an implant
may also be called "electrical connection" between an external device and an
implant. The
conductive communication may be achieved by placing a conductive member of the
external
device in contact with the skin of the patient. By doing this, the external
device and/or the implant
may assure that it is in direct electrical connection with the other device.
The concept relies on
using the inherent conductive or electrical properties of a human body.
Signals may preferably be
configured to affect the body or body functions minimally. For conductive
communication this may
mean using low currents. A current may flow from an external device to an
implant or vice versa.
Also, for conductive communication, each device may have a transceiver portion
for transmitting
or receiving the current. These may comprise amplifiers for amplifying at
least the received
current. The current may contain or carry a signal which may carry e.g., an
authentication input,
implant operation instructions, or information pertaining to the operation of
the implant.
Alternatively, conductive communication may be referred to as electrical or
ohmic or
resistive communication.
The conductive member may be an integrated part of the external device (e.g.
in the surface
of a smartwatch that is intended to be in contact with the wrist of the person
wearing it), or it may
be a separate device which can be connected to the external device using a
conductive interrace
such as the charging port or the headphone port of a smartphone.
A conductive member may be considered any device or structure set up for data
communication with the implant via electric conductive body tissue. The data
communication to
the implant may be achieved by e.g. current pulses transmitted from the
conductive member
through the body of the patient to be received by a receiver at the implant.
Any suitable coding
scheme known in the art may be employed. The conductive member may comprise an
energy
storage unit such as a battery or receive energy from e.g. a connected
external device.
The term conductive interface is representing any suitable interface
configured for data
exchange between the conductive member and the external device. The conductive
member may in
an alternative configuration receive and transmit data to the external device
through a radio
interface, NFC, and the like.
An external device may act as a relay for communication between an implant and
a remote
device, such as e.g., second, third, or other external devices. Generally, the
methods of relaying
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communication via an external device may be preferable for a large number of
reasons. The
transmission capabilities of the implant may be reduced, reducing its
technical complexity, physical
dimensions, and medical effects on the patient in which the implant is
implanted. Communication
may also be more efficient as direct communication, i.e., without a relaying
device, with an implant
from a remote device may require higher energy transmissions to account for
different mediums
and different rates of attenuation for different communication means. Remote
communication with
lower transmission energy may also increase the security of the communication
as the spatial area
or volume where the communication may be at all noticeable may be made
smaller. Utilizing such
a relay system further enables the use of different communication means for
communication with
the implant and communication with remote devices that are more optimized for
their respective
mediums.
An external device may be any device having processing power or a processor to
perform
the methods and functions needed to provide safe operation of the implant and
provide the patient
or other stakeholders (caregiver, spouse, employer etc.) with information and
feedback from the
implant. Feedback parameters could include battery status, energy level at the
controller, the fluid
level of a hydraulic construction device or sensor, number of operations that
the stimulation device
has performed, blood pressure in the renal artery, a systemic blood pressure
of the patient, version
number etc. relating to functionality of the implantable device. The external
device may for
example be a handset such as a smartphone, smartwatch, tablet etc. handled by
the patient or other
stakeholders. The external device may be a server or personal computer handled
by the patient or
other stakeholders. The external device may be cloud based or a virtual
machine. In the drawings,
the external device handled by the patient is often shown as a smart watch, or
a device adapted to
be worn by the patient at the wrist of the patient. This is merely by way of
example and any other
type of external device, depending on the context, is equally applicable.
Several external devices may exist such as a second external device, a third
external device,
or another external device. The above listed external devices may e.g., be
available to and
controllable by a patient, in which an implant is implanted, a caregiver of
the patient, a healthcare
professional of the patient, a trusted relative of the patient, an employer or
professional superior of
the patient, a supplier or producer of the implant or its related features. By
controlling the external
devices may provide options for e.g. controlling or safeguarding a function of
the implant,
monitoring the function of the implant, monitoring parameters of the patient,
updating or amending
software of the implant etc.
An external device under control by a supplier or producer of the implant may
be
connected to a database comprising data pertaining to control program updates
and/or instructions.
Such database may be regularly updated to provide new or improved
functionality of the implant,
or to mitigate for previously undetected flaws of the implant. When an update
of a control program
of an implant is scheduled, the updated control program may be transmitted
from the database in a
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push mode and optionally routed via one or more further external devices
before received by the
implanted controller. In another embodiment, the update is received from the
database by request
from e.g. an external device under control by the patient having the implant
implanted in his/her
body, a pull mode.
The external device may require authentication to be operated in communication
with other
external devices or the implant. Passwords, multi-factor authentication,
biometric identification
(fingerprint, iris scanner, facial recognition, etc.) or any other way of
authentication may be
employed.
The external device may have a user interface (UI) for receiving input and
displaying
information/feedback from/to a user. The UI may be a graphical UI (GUI), a
voice command
interface, speaker, vibrators, lamps, etc.
The communication between external devices, or between an external device and
the
implant may be encrypted. Any suitable type of encryption may be employed such
as symmetric or
asymmetric encryption. The encryption may be a single key encryption or a
multi-key encryption.
In multi-key encryption, several keys are required to decrypt encrypted data.
The several keys may
be called first key, second key, third key, etc. or first part of a key,
second part of the key, third part
of the key, etc. The several keys are then combined in any suitable way
(depending on the
encryption method and use case) to derive a combined key which may be used for
decryption. In
some cases, deriving a combined key is intended to mean that each key is used
one by one to
decrypt data, and that the decrypted data is achieved when using the final
key.
In other cases, the combination of the several key result in one "master key"
which will
decrypt the data. In other words, it is a form of secret sharing, where a
secret is divided into parts,
giving each participant (external device(s), internal device) its own unique
part. To reconstruct the
original message (decrypt), a minimum number of parts (keys) is required. In a
threshold scheme
this number is less than the total number of parts (e.g., the key at the
implant and the key from one
of the two external device are needed to decrypt the data). In other
embodiments, all keys are
needed to reconstruct the original secret, to achieve the combined key which
may decrypt the data.
In should be noted that it is not necessary that the generator of a key for
decryption is the
unit that in the end sends the key to another unit to be used at that unit. In
some cases, the generator
of a key is merely a facilitator of encryption/decryption, and the working on
behalf of another
device/user.
A verification unit may comprise any suitable means for verifying or
authenticating the use
(i.e., user authentication) of a unit comprising or connected to the
verification unit, e.g. the external
device. For example, a verification unit may comprise or be connected to an
interface (UI, GUI) for
receiving authentication input from a user. The verification unit may comprise
a communication
interface for receiving authentication data from a device (separate from the
external device)
connected to the device comprising the verification unit. Authentication
input/data may comprise a
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code, a key, biometric data based on any suitable techniques such as
fingerprint, a palm vein
structure, image recognition, face recognition, iris recognition, a retinal
scan, a hand geometry, and
genome comparison, etc. The verification/authentication may be provided using
third party
applications, installed at or in connection with the verification unit.
The verification unit may be used as one part of a two-part authentication
procedure. The
other part may, e.g., comprise conductive communication authentication,
sensation authentication,
or parameter authentication.
The verification unit may comprise a card reader for reading a smart card. A
smart card is a
secure microcontroller that is typically used for generating, storing and
operating on cryptographic
1 0 keys. Smart card authentication provides users with smart card devices
for the purpose of
authentication. Users connect their smart card to the verification unit.
Software on the verification
unit interacts with the keys material and other secrets stored on the smart
card to authenticate the
user. In order for the smart card to operate, a user may need to unlock it
with a user-PIN. Smart
cards are considered a very strong form of authentication because
cryptographic keys and other
secrets stored on the card are very well protected both physically and
logically and are therefore
hard to steal.
The verification unit may comprise a personal e-ID that is comparable to, for
example,
passport and driving license. The e-ID system comprises is a security software
installed at the
verification unit, and a e-ID which is downloaded from a web site of a trusted
provided or provided
via a smart card from the trusted provider.
The verification unit may comprise software for SMS-based two-factor
authentication. Any
other two-factor authentication systems may be used. Two-factor authentication
requires two things
to get authorized: something you know (your password, code, etc.) and
something you have (an
additional security code from your mobile device (e.g., a SMS, or a e-ID) or a
physical token such
as a smart card).
Other types of verification/user authentication may be employed. For example,
a
verification unit which communicate with an external device using visible
light instead of wired
communication or wireless communication using radio. A light source of the
verification unit may
transmit (e.g. by flashing in different patterns) secret keys or similar to
the external device which
uses the received data to verify the user, decrypt data or by any other means
perform
authentication. Light is easier to block and hide from an eavesdropping
adversary than radio waves,
which thus provides an advantage in this context. In similar embodiments,
electromagnetic
radiation is used instead of visible light for transmitting verification data
to the external device.
Parameters relating to functionality of the implant may comprise for example a
status
indicator of the implant such as battery level, version of control program,
properties of the implant,
status of a motor of the implant, temperature of the implant (such as the
battery or control unit), etc.
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Data comprising operating instructions sent to the implant may comprise a new
or updated
control program, parameters relating to specific configurations of the
implant, etc. Such data may
for example comprise instructions how to operate the body engaging portion of
the implantable
device, such as the electrode arrangement of the stimulation or damping
device, instructions to
5 collect patient data, instructions to transmit feedback, etc.
The expressions "confirming the electrical connection between an implant and
an external
device" or "authenticating a connection between an implant and an external
device", or similar
expressions, are intended to encompass methods and processes for ensuring or
be reasonably sure
that the connection has not been compromised. Due to weaknesses in the
wireless communication
1 0 protocols, it is a simple task for a device to "listen" to the data and
grab sensitive information, e.g.
personal data regarding the patient sent from the implant, or even to try to
compromise (hack) the
implant by sending malicious commands or data to the implant. Encryption may
not always be
enough as a security measure (encryption schemes may be predictable), and
other means of
confirming or authenticating the external device being connected to the
implant may be needed.
15 The expression "network protocol" is intended to encompass communication
protocols
used in computer networks. a communication protocol is a system of rules that
allow two or more
entities of a communications system to transmit information via any kind of
variation of a physical
quantity. The protocol defines the rules, syntax, semantics and
synchronization of communication
and possible error recovery methods. Protocols may be implemented by hardware,
software, or a
20 combination of both. Communication protocols have to be agreed upon by
the parties involved. In
this field, the term "standard" and "proprietary" is well defined. A
communication protocol may be
developed into a protocol standard by getting the approval of a standards
organization. To get the
approval the paper draft needs to enter and successfully complete the
standardization process.
When this is done, the network protocol can be referred to a "standard network
protocol" or a
25 "standard communication protocol". Standard protocols are agreed and
accepted by whole industry.
Standard protocols are not vendor specific. Standard protocols are often, as
mentioned above,
developed by collaborative effort of experts from different organizations.
Proprietary network protocols, on the other hand, are usually developed by a
single
company for the devices (or Operating System) which they manufacture. A
proprietary network
30 protocol is a communications protocol owned by a single organization or
individual. Specifications
for proprietary protocols may or may not be published, and implementations are
not freely
distributed. Consequently, any device may not communicate with another device
using a
proprietary network protocol, without having the license to use the
proprietary network protocol,
and knowledge of the specifications for proprietary protocol. Ownership by a
single organization
35 thus gives the owner the ability to place restrictions on the use of the
protocol and to change the
protocol unilaterally.
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A control program is intended to define any software used for controlling the
implant. Such
software may comprise an operating system of the implant, of parts of an
operating system or an
application running on the implant such as software controlling a specific
functionality of the
implant (e.g. the active unit of the implant, feedback functionality of the
implant, a transceiver of
the implant, encoding/decoding functionality of the implant, etc.). The
control program may thus
control the medical function of the implant, for example the pressure applied
by the device or the
power of the electrical stimulation device. Alternatively, or additionally,
the control program may
control internal hardware functionality of the implant such as energy usage,
transceiver
functionality, etc.
The systems and methods disclosed hereinabove may be implemented as software,
firmware, hardware or a combination thereof. In a hardware implementation, the
division of tasks
between functional units referred to in the above description does not
necessarily correspond to the
division into physical units; to the contrary, one physical component may have
multiple
functionalities, and one task may be carried out by several physical
components in cooperation.
Certain components or all components may be implemented as software executed
by a digital
signal processor or microprocessor or be implemented as hardware or as an
application-specific
integrated circuit. Such software may be distributed on computer readable
media, which may
comprise computer storage media (or non-transitory media) and communication
media (or
transitory media). As is well known to a person skilled in the art, the term
computer storage media
includes both volatile and non-volatile, removable and non-removable media
implemented in any
method or technology for storage of information such as computer readable
instructions, data
structures, program modules or other data. Computer storage media includes,
but is not limited to,
RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, digital
versatile
disks (DVD) or other optical disk storage, magnetic cassettes, magnetic tape,
magnetic disk storage
or other magnetic storage devices, or any other medium which can be used to
store the desired
information, and which can be accessed by a computer. Further, it is well
known to the skilled
person that communication media typically embodies computer readable
instructions, data
structures, program modules or other data in a modulated data signal such as a
carrier wave or other
transport mechanism and includes any information delivery media.
A controller for controlling the implantable device according to any of the
embodiments
herein and for communicating with devices external to the body of the patient
and/or implantable
sensors will now be described with reference to figures 24b - 24d. Figure 24b
shows a patient when
an implantable device 100 for treating hypertension, comprising a controller
300, has been
implanted. The implantable device 100 may for example be the stimulation
device 110 described in
any one of figures 4-6, 8 and 11, the signal damping device 120 described in
any of figures 6-8 and
11, or a sensor 140 described with reference to figures 11-14. The implantable
device 100 may
comprise an active unit 302, which is the part of the implantable device which
comprises the one or
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more operation device, which may be a means providing a hydraulic, pneumatic,
or mechanical
action for operating a sensor device 140 as shown in figures 13a-b. The active
unit may be directly
or indirectly connected to the body of the patient for causing the sensor to
abut the outside of the
blood vessel 20 to generate a signal indicative of a blood pressure in the
blood vessel 20.
Alternatively, the active unit 302 may be the functionality of the implantable
device which
generates the electrical stimulation and/or damping signal for inducing
vasodilation in the renal
artery or reducing spreading of the stimulation signal, as previously
discussed. The active unit 302
may in such examples comprise an energy source, such as a battery, or be
connected to such an
energy source, and may in further examples comprise the control unit
generating said signals. The
active unit 302 may be connected to the controller 300 via an electrical
connection C2. The
controller 300 (further described with reference to figure 24c) is configured
to communicate with
an external device 320 (further described with reference to figure 24d). The
controller 300 can
communicate wirelessly with the external device 320 through a wireless
connection WL1, and/or
through an electrical connection Cl.
Referring now to figure 24c, one embodiment of the controller 300 will be
described in
more detail. The controller 300, which may be similar to any one of the
control units 114, 124, 150
described in connection with e.g. figures 4-8, 11 and 14, may comprise an
internal computing unit
306 configured to control the function performed by the implantable device
100. The computing
unit 306 comprises an internal memory 307 configured to store programs
thereon. In the
.. embodiment described in fig. 24c, the internal memory 307 comprises a first
control program 310
which can control the function of the implantable device 100. The first
control program 310 may be
seen as a program with minimum functionality to be run at the implantable
device only during
updating of the second control program 312. When the implantable device is
running with the first
control program 310, the implantable device may be seen as running in safe
mode, with reduced
functionality. For example, the first control program 310 may result in that
no sensor data is stored
in the implantable device while being run, or that no feedback is transmitted
from the implantable
device while the first control program 310 is running. By having a low
complexity first control
program, memory at the implantable device is saved, and the risk of failure of
the implantable
device during updating of the second control program 312 is reduced.
The second control program 312 is the program controlling the implantable
device in
normal circumstances, providing the implantable device with full functionality
and features.
The memory 307 can further comprise a second, updatable, control program 312.
The tern)
updatable is to be interpreted as the program being configured to receive
incremental or iterative
updates to its code, or be replaced by a new version of the code. Updates may
provide new and/or
improved functionality to the implant as well as fixing previous deficiencies
in the code. The
computing unit 306 can receive updates to the second control program 312 via
the controller 300.
The updates can be received wirelessly WL1 or via the electrical connection
Cl. As shown in
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figure 24c, the internal memory 307 of the controller 300 can possibly store a
third program 314.
The third program 314 can control the function of the implantable device 100
and the computing
unit 306 may be configured to update the second program 312 to the third
program 314. The third
program 314 can be utilized when rebooting an original state of the second
program 312. The third
program 314 may thus be seen as providing a factory reset of the controller
300, e.g. restore it back
to factory settings. The third program 314 may thus be included in the implant
300 in a secure part
of the memory 307 to be used for resetting the software (second control
program 312) found in the
controller 300 to original manufacturer settings.
The controller 300 may comprise a reset function 316 connected to or part of
the internal
computing unit 306 or transmitted to said internal computing unit 306. The
reset function 316 is
configured to make the internal computing unit 306 switch from running the
second control
program 312 to the first control program 310. The reset function 316 could be
configured to make
the internal computing unit 306 delete the second control program 312 from the
memory 307. The
reset function 316 can be operated by palpating or pushing/put pressure on the
skin of the patient.
This could be performed by having a button on the implant. Alternatively, the
reset function 316
can be invoked via a timer or a reset module. Temperature sensors and/ or
pressure sensors can be
utilized for sensing the palpating. The reset function 316 could also be
operated by penetrating the
skin of the patient. It is further plausible that the reset function 316 can
be operated by magnetic
means. This could be performed by utilizing a magnetic sensor and applying a
magnetic force from
outside the body. The reset function 316 could be configured such that it only
responds to magnetic
forces applied for a duration of time exceeding a limit, such as 2 seconds.
The time limit could
equally plausible be 5 or 10 seconds, or longer. In these cases, the implant
could comprise a timer.
The reset function 316 may thus include or be connected to a sensor for
sensing such magnetic
force.
In addition to or as an alternative to the reset function described above, the
implant may
comprise an internal computing unit 306 (comprising an internal processor)
comprising the second
control program 312 for controlling a function of the implantable device, and
a reset function 318.
The reset function 318 may be configured to restart or reset said second
control program 312 in
response to: i. a timer of the reset function 318 has not been reset, or ii. a
malfunction in the first
control program 310.
The reset function 318 may comprise a first reset function, such as, for
example, comprise
a computer operating properly, COP, function connected to the internal
computing unit 306. The
first reset function may be configured to restart or reset the first or the
second control program 312
using a second reset function. The first reset function comprises a timer, and
the first or the second
control program is configured to periodically reset the timer.
The reset function 318 may further comprise a third reset function connected
to the internal
computing unit and to the second reset function. The third reset function may
in an example be
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configured to trigger a corrective function for correcting the first 310 or
second control program
312, and the second reset function is configured to restart the first 310 or
second control program
312 some time after the corrective function has been triggered. The corrective
function may be a
soft reset or a hard reset.
The second or third reset function may, for example, configured to invoke a
hardware reset
by triggering a hardware reset by activating an internal or external pulse
generator which is
configured to create a reset pulse. Alternatively, the second or third reset
function may be
implemented by software.
The controller 300 may further comprise an internal wireless transceiver 308.
The
transceiver 308 communicates wirelessly with the external device 320 through
the wireless
connection Wl. The transceiver may further communicate with an external device
320, 300 via
wireless connection WL2 or WL4. The transceiver may both transmit and receive
data via either of
the connections Cl, WL1, WL2 and WL4. Optionally, the external devices 320 and
300, when
present, may communicate with each other, for example via a wireless
connection WL3.
The controller 300 can further be electrically connected Cl to the external
device 320 and
communicate by using the patient's body as a conductor. The controller 300 may
thus comprise a
wired transceiver 303 or an internal transceiver 303 for the electrical
connection Cl.
The confirmation/authentication of the electrical connection can be performed
as described
herein in the section for confirmation and/or authentication. In these cases,
the implantable device
and/or external device(s) 320 comprises the necessary features and
functionality (described in the
respective sections of this document) for performing such
confirmation/authentication. By
authenticating according to these aspects, security of the authentication may
be increased as it may
require a malicious third party to know or gain access to either the transient
physiological
parameter of the patient or detect randomized sensations generated at or
within the patient.
In figures 24b ¨ 24d the patient is a human, but other mammals are equally
plausible. It is
also plausible that the communication is performed by inductive means. It is
also plausible that the
communication is direct, without being relayed via any intermediate means or
functions.
The controller 300 of the implantable device 100 according to figure 24c
further comprises
a feedback unit 349. The feedback unit 349 provides feedback related to the
switching from the
second control program 312 to the first control program 310. The feedback
could for example
represent the information on when the update of the software, i.e. the second
control program 312,
has started, and when the update has finished. This feedback can be visually
communicated to the
patient, via for example a display on the external device 320. This display
could be located on a
watch, or a phone, or any other external device 320 coupled to the controller
300. Preferably, the
feedback unit 349 provides this feedback signal wirelessly WL1 to the external
device 320.
Potentially, the words "Update started", or "Update finished", could be
displayed to the patient, or
similar terms with the same meaning. Another option could be to display
different colors, where
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green for example could mean that the update has finished, and red or yellow
that the update is
ongoing. Obviously, any color is equally plausible, and the user could choose
these depending on
personal preference. Another possibility would be to flash a light on the
external device 320. In this
case the external device 320 comprises the light emitting device(s) needed.
Such light could for
5 example be a LED. Different colors could, again, represent the status of
the program update. One
way of representing that the update is ongoing and not yet finished could be
to flash the light, i.e.
turning the light on and off Once the light stops flashing, the patient would
be aware of that the
update is finished. The feedback could also be audible, and provided by the
implantable device 300
directly, or by the external device 320. In such cases, the implantable device
100 and external
10 device 320 comprises means for providing audio. The feedback could also
be tactile, for example
in the form of a vibration that the user can sense. In such case, either the
implantable device 100 or
external device 320 comprises means for providing a tactile sensation, such as
a vibration and/or a
vibrator.
As seen in figure 24c, the controller 300 can further comprise a first energy
storage unit
15 40A. The first energy storage unit 40A runs the first control program
310. The controller 300
further comprises a second energy storage unit 40B which runs the second
control program 312.
This may further increase security during update, since the first control
program 310 has its own
separate energy storage unit 40A. The first power supply 40A can comprise a
first energy storage
304a and/or a first energy receiver 305a. The second energy storage unit 40B
can comprise a
20 second energy storage 304b and/or a second energy receiver 305b. The
energy can be received
wirelessly by inductive or conductive means. An external energy storage unit
can for example
transfer an amount of wireless energy to the energy receiver 305a, 305b inside
the patient's body
by utilizing an external coil which induces a voltage in an internal coil (not
shown in figures). It is
plausible that the first energy receiver 305a receives energy via a RFID
pulse. The feedback unit
25 349 can provide feedback pertaining to the amount of energy received via
the RFID pulse. The
amount of RFID pulse energy that is being received can be adjusted based on
the feedback, such
that the pulse frequency is successively raised until a satisfying level is
reached.
The controller 300 of the implantable device 100 according to figure 24c
further comprises
a feedback unit an electrical switch 309. The electrical switch 309 could be
mechanically
30 connected to the implantable element configured to exert a force on a
body portion of a patient and
being configured to be switched as a result of the force exerted on the body
portion of a patient
exceeding a threshold value. The switch 309 could for example be electrically
connected to the
operation device, which may be understood as a device powering electrode
elements of the
stimulation and/or signal damping device, or a controller configured to
control the operation
35 thereof, and being configured to be switched as a result of the supplied
current exceeding a
threshold value. The switch 309 could for example be connected to a hydraulic
pump or motor for
operating the sensor device 140 shown in figures 13a-b and be configured to be
switched if the
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current exceeds a threshold value. Such a switch could for example be a switch
309 configured to
switch if exposed to a temperature exceeding a threshold value, such as a
bimetal switch which is
switched by the heat created by the flow of current to e.g. the motor. In the
alternative, the switch
309 configured to switch if exposed to a temperature exceeding a threshold
value could be placed
at a different location on the implantable device 100 to switch in case of
exceeding temperatures,
thereby hindering the implantable device from overheating which may cause
tissue damage.
The switch 309 could either be configured to cut the power to the operation
device or to
generate a control signal to the processor 306 of the implantable controller
300, such that the
controller 300 can take appropriate action, such as reducing power or turning
off the operation
device.
The external device 320 is represented in figure 24d. The external device 320
can be placed
anywhere on the patient's body, preferably on a convenient and comfortable
place. The external
device 320 could be a wristband, and/or have the shape of a watch. It is also
plausible that the
external device is a mobile phone or other device not attached directly to the
patient. The external
device as shown in figure 24d comprises a wired transceiver 323, and an energy
storage 324. It also
comprises a wireless transceiver 328 and an energy transmitter 325. It further
comprises a
computing unit 326 and a memory 327. The feedback unit 322 in the external
device 320 is
configured to provide feedback related to the computing unit 326. The feedback
provided by the
feedback unit 322 could be visual. The external device 320 could have a
display showing such
visual feedback to the patient. It is equally plausible that the feedback is
audible, and that the
external device 320 comprises means for providing audio. The feedback given by
the feedback unit
322 could also be tactile, such as vibrating. The feedback could also be
provided in the form of a
wireless signal WL1, WL2, WL3, WL4.
The second, third or fourth communication methods WL2, WL3, WL4 may be a
wireless
form of communication. The second, third or fourth communication method WL2,
WL3, WL4 may
preferably be a form of electromagnetic or radio-based communication. The
second, third and
fourth communication method WL2, WL3, WL4 may be based on telecommunication
methods.
The second, third or fourth communication method WL2, WL3, WL4 may comprise or
be related
to the items of the following list: Wireless Local Area Network (WLAN),
Bluetooth, Bluetooth 5,
BLE, GSM or 2G (2nd generation cellular technology), 3G, 4G or 5G.
The external device 320 may be adapted to be in electrical connection Cl with
the
implantable device 100, using the body as a conductor. The electrical
connection Cl is in this case
used for conductive communication between the external device 320 and the
implantable device
100.
In one embodiment, the communication between controller 300 and the external
device 320
over either of the communication methods WL2, WL3, WL4, Cl may be encrypted
and/or
decrypted with public and/or private keys, now described with reference to
Figs. 24b ¨ 24d. For
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example, the controller 300 may comprise a private key and a corresponding
public key, and the
external device 320 may comprise a private and a corresponding public key.
The controller 320 and the external device 320 may exchange public keys and
the
communication may thus be performed using public key encryption. The person
skilled in the art
may utilize any known method for exchanging the keys.
The controller may encrypt data to be sent to the external device 320 using a
public key
corresponding to the external device 320. The encrypted data may be
transmitted over a wired,
wireless or electrical communication channel Cl, WL1, WL2, WL3 to the external
device. The
external device 320 may receive the encrypted data and decode it using the
private key comprised
in the external device 320, the private key corresponding to the public key
with which the data has
been encrypted. The external device 320 may transmit encrypted data to the
controller 300. The
external device 320 may encrypt the data to be sent using a public key
corresponding to the private
key of the controller 300. The external device 320 may transmit the encrypted
data over a wired,
wireless or electrical connection Cl, WL1, WL2, WL3, WL4, directly or
indirectly, to the
controller of the implant. The controller may receive the data and decode it
using the private key
comprised in the controller 300.
In an alternative to the public key encryption, described with reference to
figs. 24b ¨ 24d,
the data to be sent between the controller 300 of the implantable device 100
and an external device
320, 330 or between an external device 320, 330 and the controller 300 may be
signed. In a method
for sending data from the controller 300 to the external device 320, 330, the
data to be sent from
the controller 300 may be signed using the private key of the controller 300.
The data may be
transmitted over a communication channel or connection Cl, WL1, WL2, WL3, WL4.
The external
device 320, 330 may receive the message and verify the authenticity of the
data using the public
key corresponding to the private key of the controller 300. In this way, the
external device 320, 330
may determine that the sender of the data was sent from the controller 300 and
not from another
device or source.
A method for communication between an external device 320 and the controller
300 of the
implantable device 100 using a combined key is now described with reference to
figs. 24b ¨ 24d. A
first step of the method comprises receiving, at the implant, by a wireless
transmission WL1, WL2,
WL3, WL4 or otherwise, a first key from an external device 320, 330. The
method further
comprises receiving, at the implant, by a wireless transmission WL1, WL2, WL3,
a second key.
The second key may be generated by a second external device, separate from the
external device
320, 330 or by another external device being a generator of the second key on
behalf of the second
external device 320, 330. The second key may be received at the implant from
anyone of, the
external device 320, the second external device 330, and the generator of the
second key. The
second external device may be controlled by a caretaker, or any other
stakeholder. Said another
external device may be controlled by a manufacturer of the implant, or medical
staff, caretaker, etc.
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In case the controller 300 is receiving the second key from the external
device 320, this
means that the second key is routed through the external device from the
second external device
330 or from another external device (generator). The routing may be performed
as described herein
under the tenth aspect. In these cases, the implant and/or external device(s)
comprises the necessary
features and functionality (described in the respective sections of this
document) for performing
such routing. Using the external device 320 as a relay, with or without
verification from the patient,
may provide an extra layer of security as the external device 320 may not need
to store or otherwise
handle decrypted information. As such, the external device 320 may be lost
without losing
decrypted information. The controller 300 a computing unit 306 configured for
deriving a
combined key by combining the first key and the second key with a third key
held by the controller
300, for example in memory 307 of the controller 300. The third key could for
example be a license
number of the implant or a chip number of the implantable device. The combined
key may be used
for decrypting, by the computing unit 306, encrypted data transmitted by a
wireless transmission
WL1 from the external device 320 to the controller 300. Optionally, the
decrypted data may be
used for altering, by the computing unit 306 an operation of the implantable
device. The altering an
operation of the implantable device may comprise controlling or switching an
active unit 302 of the
implant. In some embodiments, the method further comprises at least one of the
steps of, based on
the decrypted data, updating a control program running in the controller 300,
and operating the
implantable device 100 using operation instructions in the decrypted data.
Methods for encrypted communication between an external device 320 and the
controller
300 will now be described. These methods may comprise:
receiving, at the external device 320, by a wireless transceiver 328, a first
key, the first key
being generated by a second external device 330, separate from the external
device 320 or by
another external device being a generator of the second key on behalf of the
second external device
330, the first key being received from anyone of the second external device
330 and the generator
of the second key,
receiving, at the external device 320 by the wireless transceiver 328, a
second key from the
controller 300,
deriving a combined key, by a computing unit 326 of the external device 320,
by
combining the first key and the second key with a third key held by the
external device 320 (e.g. in
memory 307),
transmitting encrypted data from the implant to the external device and
receiving the
encrypted data at the external device by the wireless transceiver 328, and
decrypting, by the computing unit 326, the encrypted data, in the external
device 320, using
the combined key.
As described above, further keys may be necessary to decrypt the data.
Consequently, the
wireless transceiver 328 is configured for:
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receiving a fourth key from a third external device,
wherein the computing unit 326 is configured for:
deriving a combined key by combining the first, second and fourth key with the
third key
held by the external device, and
decrypting the encrypted data using the combined key.
These embodiments further increase the security in the communication. The
computing
unit 326 may be configured to confirm the communication between the implant
and the external
device, wherein the confirmation comprises:
measuring a parameter of the patient, by the external device 320,
receiving a measured parameter of the patient, from the implantable device
100,
comparing the parameter measured by the implantable device 100 to the
parameter
measured by the external device 320,
performing confirmation of the connection based on the comparison, and
as a result of the confirmation, decrypting the encrypted data, in the
external device, using
the combined key.
The keys described in this section may in some embodiments be generated based
on data
sensed by sensors described herein under the twelfth or thirteenth aspect,
e.g. using the sensed data
as seed for the generated keys. A seed is an initial value that is fed into a
pseudo random number
generator to start the process of random number generation. The seed may thus
be made hard to
predict without access or knowledge of the physiological parameters of the
patient which it is based
on, providing an extra level of security to the generated keys.
Further, increased security for communication between an external device(s)
and the
implantable device is provided.
A method of communication between an external device 320 and an implantable
device
100 is now described with reference to Figs. 24b ¨ 24d, when the implantable
device 100 is
implanted in a patient and the external device 320 is positioned external to
the body of the patient.
The external device 320 is adapted to be in electrical connection Cl with the
controller 300, using
the body as a conductor. The electrical connection Cl is used for conductive
communication
between the external device 320 and the implantable device 100. The
implantable device 100
comprises the controller 300. Both the controller 300 and the external device
320 comprises a
wireless transceiver 308, 208 for wireless communication Cl between the
controller 300 and the
external device 320. The wireless transceiver 308 (included in the controller
300) may in some
embodiments comprise sub-transceivers for receiving data from the external
device 320 and other
external devices, e.g. using different frequency bands, modulation schemes
etc.
In a first step of the method, the electrical connection Cl between the
controller 300 and
the external device 320 is confirmed and thus authenticated. The implant
and/or external device(s)
may comprise the necessary features and functionality (described in the
present disclosure) for
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performing such authentication. By such an authentication, security of the
authentication may be
increased as it may require a malicious third party to know or gain access to
either the transient
physiological parameter of the patient or detect randomized sensations
generated at or within the
patient.
5 The implant may comprise a first transceiver 303 configured to be in
electrical connection
Cl with the external device, using the body as a conductor. The implant may
comprise a first
external transmitter 203 configured to be in electrical connection Cl with the
implant, using the
body as a conductor, and the wireless transmitter 208 configured to transmit
wireless
communication W1 to the controller 300. The first transmitter 323 of the
external device 320 may
10 be wired or wireless. The first transmitter 323 and the wireless
transmitter 208 may be the same or
separate transmitters. The first transceiver 303 of the controller 300 may be
wired or wireless. The
first transceiver 303 and the wireless transceiver 102 may be the same or
separate transceivers.
The controller 300 may comprise a computing unit 306 configured to confirm the
electrical
connection between the external device 320 and the internal transceiver 303
and accept wireless
15 communication WL1 (of the data) from the external device 320 on the
basis of the confirmation.
Data is transmitted from the external device 320 to the controller 300
wirelessly, e.g. using
the respective wireless transceiver 308, 208 of the controller 300 and the
external device 320. Data
may alternatively be transmitted through the electrical connection Cl. As a
result of the
confirmation, the received data may be used for instructing the implantable
device 100. For
20 example, a control program 310 running in the controller 300 may be
updated, the controller 300
may be operated using operation instructions in the received data. This may be
handled by the
computing unit 306.
The method may comprise transmitting encrypted data from the external device
320 to the
controller 300 wirelessly. To decrypt the encrypted data (for example using
the computing unit
25 .. 306), several methods may be used.
In one embodiment, a key is transmitted using the confirmed conductive
communication
channel Cl (i.e. the electrical connection) from the external device 320 to
the controller 300. The
key is received at the controller (by the first internal transceiver 303). The
key is then used for
decrypting the encrypted data.
30 In some embodiments the key is enough to decrypt the encrypted data. In
other
embodiments, further keys are necessary to decrypt the data. In one
embodiment, a key is
transmitted using the confirmed conductive communication channel Cl (i.e. the
electrical
connection) from the external device 320 to the controller 300. The key is
received at the controller
300 (by the first internal transceiver 303). A second key is transmitted (by
the wireless transceiver
35 208) from the external device 320 using the wireless communication WL1
and received at the
controller 300 by the wireless transceiver 308. The computing unit 306 is then
deriving a combined
key from the key and second key and uses this for decrypting the encrypted
data.
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In yet other embodiments, a key is transmitted using the confirmed conductive
communication channel Cl (i.e. the electrical connection) from the external
device 320 to the
controller 300. The key is received at the controller (by the first internal
transceiver 303). A third
key is transmitted from a second external device 330, separate from the
external device 320, to the
implant wirelessly WL2. The third key may be received by a second wireless
receiver (part of the
wireless transceiver 308) of the controller 300 configured for receiving
wireless communication
WL2 from second external device 330.
The first and third key may be used to derive a combined key by the computing
unit 306,
which then decrypts the encrypted data. The decrypted data is then used for
instructing the
implantable device 100 as described above.
The second external device 330 may be controlled by for example a caregiver,
to further
increase security and validity of data sent and decrypted by the controller
300.
It should be noted that in some embodiments, the external device is further
configured to
receive WL2 secondary wireless communication from the second external device
330, and transmit
data received from the secondary wireless communication WL2 to the implantable
device. This
routing of data may be achieved using the wireless transceivers 308, 208 (i.e.
the wireless
connection WL1, or by using a further wireless connection WL4 between the
controller 300 and the
external device 320. In these cases, the implant and/or external device(s)
comprises the necessary
features and functionality for performing such routing. Consequently, in some
embodiments, the
third key is generated by the second external device 330 and transmitted WL2
to the external
device 320 which routes the third key to the controller 300 to be used for
decryption of the
encrypted data. In other words, the step of transmitting a third key from a
second external device,
separate from the external device, to the implant wirelessly, comprises
routing the third key
through the external device 320. Using the external device 320 as a relay,
with or without
verification from the patient, may provide an extra layer of security as the
external device 320 may
not need to store or otherwise handle decrypted information. As such, the
external device 320 may
be lost without losing decrypted information.
In yet other embodiments, a key is transmitted using the confirmed conductive
communication channel Cl (i.e. the electrical connection) from the external
device 320 to the
controller 300. The key is received at the implant (by the first internal
transceiver 303). A second
key is transmitted from the external device 320 to the controller 300
wirelessly WL1, received at
the at the controller 300. A third key is transmitted from the second external
device, separate from
the external device 320, to the controller 300 wirelessly WL4. Encrypted data
transmitted from the
external device 320 to the controller 300 is then decrypted using a derived
combined key from the
key, the second key and the third key. The external device may be a wearable
external device.
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The external device 320 may be a handset. The second external device 330 may
be a
handset. The second external device 330 may be a server. The second external
device 330 may be
cloud based.
In some embodiments, the electrical connection Cl between the external device
320 and
the controller 300 is achieved by placing a conductive member 201, configured
to be in connection
with the external device 200, in electrical connection with a skin of the
patient for conductive
communication Cl with the implant. In these cases, the implant and/or external
device(s)
comprises the necessary features and functionality (described in the
respective sections of this
document) for performing such conductive communication. The communication may
thus be
provided with an extra layer of security in addition to the encryption by
being electrically confined
to the conducting path e.g. external device 320, conductive member 201,
conductive connection
Cl, controller 300, meaning the communication will be excessively difficult to
be intercepted by a
third party not in physical contact with, or at least proximal to, the
patient.
The keys described in this section may in some embodiments be generated based
on data
sensed by sensors described herein, e.g. using the sensed data as seed for the
generated keys. A
seed is an initial value that is fed into a pseudo random number generator to
start the process of
random number generation. The seed may thus be made hard to predict without
access or
knowledge of the physiological parameters of the patient which it is based on,
providing an extra
level of security to the generated keys.
Increased security for communication between an external device(s) and an
implant is
provided, now described in the following with reference to figs. 24b ¨ 24d.
In these embodiments, a method for communication between an external device
320 and
the implantable controller 300 is provided. The wireless transceiver 308
(included in the controller
300) may in some embodiments comprise sub-transceivers for receiving data from
the external
device 320 and other external devices 330, e.g. using different frequency
bands, modulation
schemes etc.
A first step of the method comprises receiving, at the implant, by a wireless
transmission
WL1 or otherwise, a first key from an external device 320. The method further
comprises
receiving, at the implant, by a wireless transmission WL1, WL2, WL3, a second
key. The second
key may be generated by a second external device 330, separate from the
external device 320 or by
another external device being a generator of the second key on behalf of the
second external device
330. The second key may be received at the implant from anyone of, the
external device 320, the
second external device 330, and a generator of the second key. The second
external device 330 may
be controlled by a caretaker, or any other stakeholder. Said another external
device may be
controlled by a manufacturer of the implant, or medical staff, caretaker, etc.
In case the implant is receiving the second key from the external device 320,
this means
that the second key is routed through the external device from the second
external device 330 or
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from the another external device (generator). In these cases, the implant
and/or external device(s)
comprises the necessary features and functionality (described in the
respective sections of this
document) for performing such routing. Using the external device 320 as a
relay, with or without
verification from the patient, may provide an extra layer of security as the
external device 320 may
not need to store or otherwise handle decrypted information. As such, the
external device 320 may
be lost without losing decrypted information.
The controller 300 comprises a computing unit 306 configured for deriving a
combined key
by combining the first key and the second key with a third key held by the
controller 300, for
example in memory 307 of the controller. The combined key may be used for
decrypting, by the
computing unit 306, encrypted data transmitted by a wireless transmission WL1
from the external
device 320 to the controller 300. Optionally, the decrypted data may be used
for altering, by the
computing unit 306 an operation of the implantable device 100. The altering an
operation of the
implantable device may comprise controlling or switching an active unit 302 of
the implant. In
some embodiments, the method further comprises at least one of the steps of,
based on the
decrypted data, updating a control program running in the implant, and
operating the implantable
device 100 using operation instructions in the decrypted data.
In some embodiments, further keys are necessary to derive a combined key for
decrypting
the encrypted data received at the controller 100. In these embodiments, the
first and second key
are received as described above. Further, the method comprises receiving, at
the implant, a fourth
key from a third external device, the third external device being separate
from the external device,
deriving a combined key by combining the first, second and fourth key with the
third key held by
the controller 300, and decrypting the encrypted data, in the controller 300,
using the combined
key. Optionally, the decrypted data may be used for altering, by the computing
unit 306, an
operation of the implant as described above. In some embodiments, the fourth
key is routed
through the external device from the third external device.
In some embodiments, further security measures are needed before using the
decrypted
data for altering, by the computing unit 306, an operation of the implantable
device. For example,
an electrical connection Cl between the implantable device and the external
device 320, using the
body as a conductor, may be used for further verification of validity of the
decrypted data. The
electrical connection Cl may be achieved by placing a conductive member 201,
configured to be in
connection with the external device, in electrical connection with a skin of
the patient for
conductive communication Cl with the implant. The communication may thus be
provided with an
extra layer of security in addition to the encryption by being electrically
confined to the conducting
path e.g. external device 320, conductive member 201, conductive connection
Cl, controller 300,
meaning the communication will be excessively difficult to be intercepted by a
third party not in
physical contact with, or at least proximal to, the patient.
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Accordingly, in some embodiments, the method comprising confirming the
electrical
connection between the controller 300 and the external device 320, and as a
result of the
confirmation, altering an operation of the implantable device based on the
decrypted data. The
confirmation and authentication of the electrical connection may be performed
as described herein
under the general features section. In these cases, the implantable device
and/or external device(s)
320 comprises the necessary features and functionality (described in the
respective sections of this
document) for performing such authentication. By authenticating according to
these aspects,
security of the authentication may be increased as it may require a malicious
third party to know or
gain access to either the transient physiological parameter of the patient or
detect randomized
sensations generated at or within the patient.
In some embodiments, the confirmation of the electrical connection comprises:
measuring
a parameter of the patient, by e.g. a sensor of the implantable device 100,
measuring the parameter
of the patient, by the external device 320, comparing the parameter measured
by the implantable
device to the parameter measured by the external device 320, and
authenticating the connection
based on the comparison. As mentioned above, as a result of the confirmation,
an operation of the
implantable device may be altered based on the decrypted data.
Further methods for encrypted communication between an external device 320 and
an
implantable device 100 are provided. These methods comprise:
receiving, at the external device 320 by a wireless transceiver 328, a first
key, the first key
being generated by a second external device 330, separate from the external
device 320 or by
another external device being a generator of the second key on behalf of the
second external device
320, the first key being received from anyone of the second external device
330 and the generator
of the second key,
receiving, at the external device 320 by the wireless transceiver 328, a
second key from the
.. controller 300,
deriving a combined key, by a computing unit 326 of the external device 320,
by
combining the first key and the second key with a third key held by the
external device 320 (e.g. in
memory 327),
transmitting encrypted data from the implant to the external device and
receiving the
.. encrypted data at the external device by the wireless transceiver 328, and
decrypting, by the computing unit 326, the encrypted data, in the external
device 320, using
the combined key.
As described above, further keys may be necessary to decrypt the data.
Consequently, the
wireless transceiver 328 is configured for:
receiving a fourth key from a third external device,
wherein the computing unit 326 is configured for:
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deriving a combined key by combining the first, second and fourth key with the
third key
held by the external device, and
decrypting the encrypted data using the combined key.
In some embodiments, the communication between the controller 300 and the
external
5 device 320 needs to be confirmed (authenticated) before decrypting the
data. In these cases, the
implant and/or external device(s) comprises the necessary features and
functionality (described in
the respective sections of this document) for performing such authentication.
These embodiments further increase the security in the communication. In these
embodiments the computing unit 326 is configured to confirm the communication
between the
10 implant and the external device, wherein the confirmation comprises:
measuring a parameter of the patient, by the external device 320,
receiving a measured parameter of the patient, from the implantable device
100,
comparing the parameter measured by the implantable device 320 to the
parameter
measured by the external device 320,
15 performing confirmation of the connection based on the comparison, and
as a result of the confirmation, decrypting the encrypted data, in the
external device, using
the combined key.
One or more of the first, second and third key may comprise a biometric key.
The keys described in this section may in some embodiments be generated based
on data
20 sensed by sensors, e.g. using the sensed data as seed for the generated
keys. A seed is an initial
value that is fed into a pseudo random number generator to start the process
of random number
generation. The seed may thus be made hard to predict without access or
knowledge of the
physiological parameters of the patient which it is based on, providing an
extra level of security to
the generated keys.
25 Further, increased security for communication between an external
device(s) 320, 330 and
an implant is provided, described with reference to Figs. 24b ¨ 24d. The
system for communication
between an external device 320 and the controller 300 implanted in a patient.
The system
comprises a conductive member 321 configured to be in connection
(electrical/conductive or
wireless or otherwise) with the external device, the conductive member 321
being configured to be
30 placed in electrical connection with a skin of the patient for
conductive communication Cl with the
implantable device 100. By using a conductive member 321 as defined herein, an
increased
security for communication between the external device and the implant may be
achieved. For
example, when a sensitive update of a control program of the controller 300 is
to be made, or if
sensitive data regarding physical parameters of the patient is to be sent to
the external device 320
35 (or otherwise), the conductive member 321 may ensure that the patient is
aware of such
communication and actively participate in validating that the communication
may take place. The
conductive member may, by being placed in connection with the skin of the
patient, open the
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conductive communication channel Cl between the external device and the
controller to be used
for data transmission.
Electrical or conductive communication, such as this or as described under the
other
embodiments, may be very hard to detect remotely, or at least relatively so,
in relation to wireless
communications such as radio transmissions. Direct electrical communication
may further
safeguard the connection between the implantable device 100 and the external
device 320 from
electromagnetic jamming i.e. high-power transmissions other a broad range of
radio frequencies
aimed at drowning other communications within the frequency range. Electrical
or conductive
communication will be excessively difficult to be intercepted by a third party
not in physical
contact with, or at least proximal to, the patient, providing an extra level
of security to the
communication.
In some embodiments, the conductive member comprises a conductive interface
for
connecting the conductive member to the external device.
In some embodiments, the conductive member 201 is a device which is plugged
into the
external device 200, and easily visible and identifiable for simplified usage
by the patient. In other
embodiments, the conductive member 321 is to a higher degree integrated with
the external device
320, for example in the form of a case of the external device 320 comprising a
capacitive area
configured to be in electrical connection with a skin of the patient. In one
example, the case is a
mobile phone case (smartphone case) for a mobile phone, but the case may in
other embodiments
be a case for a personal computer, or a body worn camera or any other suitable
type of external
device as described herein. The case may for example be connected to the phone
using a wire from
the case and connected to the headphone port or charging port of the mobile
phone.
The conductive communication Cl may be used both for communication between the
controller 300 and the external device 320 in any or both directions.
Consequently, according to
some embodiments, the external device 320 is configured to transmit a
conductive communication
(conductive data) to the controller 300 via the conductive member 321.
According to some embodiments, the controller 300 is configured to transmit a
conductive
communication to the external device 320. These embodiments start by placing
the conductive
member 321, configured to be in connection with the external device 320, in
electrical connection
with a skin of the patient for conductive communication Cl with the controller
300. The conductive
communication between the external device 320 and the controller 300 may
follow an
electrically/conductively confined path comprising e.g. the external device
320, conductive
member 321, conductive connection Cl, controller 300.
For the embodiments when the external device 320 transmits data to the
controller, the
communication may comprise transmitting a conductive communication to the
controller 300 by
the external device 320.
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The transmitted data may comprise instructions for operating the implantable
device 100.
Consequently, some embodiments comprise operating the implantable device 100
using operation
instructions, by an internal computing unit 306 of the controller 300, wherein
the conductive
communication Cl comprises instructions for operating the implantable device
100. The operation
instruction may for example involve adjusting or setting up (e.g. properties
or functionality of) the
control unit providing the electric stimulation signal of the implantable
device 100.
The transmitted data may comprise instructions for updating a control program
310 stored
in memory 307 of the controller 300. Consequently, some embodiments comprise
updating the
control program 310 running in the controller 300, by the internal computing
unit 306 of the
implant, wherein the conductive communication comprises instructions for
updating the control
program 310.
For the embodiments when the controller 300 transmits data to the external
device 320, the
communication may comprise transmitting conductive communication Cl to the
external device
320 by the controller 300. The conductive communication may comprise feedback
parameters.
Feedback parameters could include battery status, energy level at the
controller, a fluid level of the
hydraulic constriction device or sensor, number of operations that the
stimulation device has
performed, properties, temperature, version number etc. relating to
functionality of the implantable
device 100. In other embodiments, the conductive communication Cl comprises
data pertaining to
least one physiological parameter of the patient, such as blood pressure etc.
The physiological
parameter(s) may be stored in memory 307 of the controller 300 or sensed in
prior (in real time or
with delay) to transmitting the conductive communication Cl. Consequently, in
some
embodiments, the implantable device 100 comprises a sensor 140 for sensing at
least one
physiological parameter of the patient, wherein the conductive communication
comprises said at
least one physiological parameter of the patient.
To further increase security of the communication between the controller 300
and the
external device 320, different types of authentication, verification and/or
encryption may be
employed. In some embodiments, the external device 320 comprises a
verification unit 340. The
verification unit 340 may be any type of unit suitable for verification of a
user, i.e. configured to
receive authentication input from a user, for authenticating the conductive
communication between
the implant and the external device. In some embodiments, the verification
unit and the external
device comprises means for collecting authentication input from the user
(which may or may not be
the patient). Such means may comprise a fingerprint reader, a retina scanner,
a camera, a GUI for
inputting a code, a microphone, device configured to draw blood, etc. The
authentication input may
thus comprise a code or any be based on a biometric technique selected from
the list of: a
fingerprint, a palm vein structure, image recognition, face recognition, iris
recognition, a retinal
scan, a hand geometry, and genome comparison. The means for collecting the
authentication input
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may alternatively be part of the conductive member which comprise any of the
above examples of
functionality, such as a fingerprint reader or other type of biometric reader.
In some embodiments, the security may thus be increased by receiving an
authentication
input from a user by the verification unit 340 of the external device 320, and
authenticating the
conductive communication between the controller 300 and the external device
using the
authentication input. Upon a positive authentication, the conductive
communication channel Cl
may be employed for comprising transmitting a conductive communication to the
controller 300 by
external device 320 and/or transmitting a conductive communication to the
external device 320 by
the controller 300. In other embodiments, a positive authentication is needed
prior to operating the
implantable device 100 based on received conductive communication, and/or
updating a control
program running in the controller 300 as described above.
Figs. 24b ¨ 24d further shows an implantable device 100 implanted in a patient
and being
connected to a sensation generator 381.
The sensation generator 381 may be configured to generate a sensation. The
sensation
generator 381 may be contained within the implantable device 100 or be a
separate unit. The
sensation generator 381 may be implanted. The sensation generator 381 may also
be located so that
it is not implanted as such but still is in connection with a patient so that
only the patient may
experience sensations generated. The controller 300 is configured for storing
authentication data,
related to the sensation generated by the sensation generator 381.
The controller 300 is further configured for receiving input authentication
data from the
external device 320. Authentication data related to the sensation generated
may by stored by a
memory 307 of the controller 300. The authentication data may include
information about the
generated sensation such that it may be analyzed, e.g. compared, to input
authentication data to
authenticate the connection, communication or device. Input authentication
data relates to
information generated by a patient input to the external device 320. The input
authentication data
may be the actual patient input or an encoded version of the patient input,
encoded by the external
device 320. Authentication data and input authentication data may comprise a
number of sensations
or sensation components.
The authentication data may comprise a timestamp. The input authentication
data may
comprise a timestamp of the input from the patient. The timestamps may be a
time of the event
such as the generation of a sensation by the sensation generator 381 or the
creation of input
authentication data by the patient. The timestamps may be encoded. The
timestamps may feature
arbitrary time units, i.e. not the actual time. Timestamps may be provided by
an internal clock 360
of the controller 300 and an external clock 362 of the external device 320.
The clocks 360, 362 may
be synchronized with each other. The clocks 360, 362 may be synchronized by
using a conductive
connection Cl or a wireless connection WL1 for communicating synchronization
data from the
external device 320, and its respective clock 362, to the controller 300, and
its respective clock 360,
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and vice versa. Synchronization of the clocks 360, 362 may be performed
continuously and may
not be reliant on secure communication.
Authentication of the connection may comprise calculating a time difference
between the
timestamp of the sensation and the timestamp of the input from the patient,
and upon determining
that the time difference is less than a threshold, authenticating the
connection. An example of a
threshold may be is. The analysis may also comprise a low threshold as to
filter away input from
the patient that is faster than normal human response times. The low threshold
may e.g. be 50ms.
Authentication data may comprise a number of times that the sensation is
generated by the
sensation generator, and wherein the input authentication data comprises an
input from the patient
.. relating to a number of times the patient detected the sensation.
Authenticating the connection may
then comprise: upon determining that the number of times that the
authentication data and the input
authentication data are equal, authenticating the connection.
A method of authenticating the connection between an implantable device 100
implanted in
a patient, and an external device 320 according includes the following steps.
Generating, by a sensation generator 381, a sensation detectable by a sense of
the patient.
The sensation may comprise a plurality of sensation components. The sensation
or sensation
components may comprise a vibration (e.g. a fixed frequency mechanical
vibration), a sound (e.g. a
superposition of fixed frequency mechanical vibrations), a photonic signal
(e.g. a non-visible light
pulse such as an infra-red pulse), a light signal (e.g. a visual light pulse),
an electric signal (e.g. an
electrical current pulse) or a heat signal (e.g. a thermal pulse). The
sensation generator may be
implanted, configured to be worn in contact with the skin of the patient or
capable of creating
sensation without being in physical contact with the patient, such as a
beeping alarm.
Sensations may be configured to be consistently felt by a sense of the patient
while not
risking harm to or affecting internal biological processes of the patient.
The sensation generator 381, may be contained within the controller 300 or be
a separate
entity connected to the controller 300. The sensation may be generated by a
motor (denoted as M in
several embodiments shown herein) of the implantable device 100, wherein the
motor being the
sensation generator 381. The sensation may be a vibration, or a sound created
by running the
motor. The sensation generator 381 may be located close to a skin of the
patient and thus also the
sensory receptors of the skin. Thereby the strength of some signal types may
be reduced.
Storing, by the controller 300, authentication data, related to the generated
sensation.
Providing, by the patient input to the external device, resulting in input
authentication data.
Providing the input may e.g. comprise an engaging an electrical switch, using
a biometric input
sensor or entry into digital interface running on the external device 320 to
name just a few
examples.
Transmitting the input authentication data from the external device to the
controller 300. If
the step was performed, the analysis may be performed by the controller 300.
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Transmitting the authentication data from the implantable device 100 to the
external device
320. If the step was performed, the analysis may be performed by the external
device 320. The
wireless connection WL1 or the conductive connection Cl may be used to
transmit the
authentication data or the input authentication data.
5 Authenticating the connection based on an analysis of the input
authentication data and the
authentication data e.g. by comparing a number of sensations generated and
experienced or
comparing timestamps of the authentication data and the input authentication
data. If step was
performed, the analysis may be performed by the implantable device 100.
Communicating further data between the controller 300 and the external device
320
10 following positive authentication. The wireless connection WL1 or the
conductive connection Cl
may be used to communicate the further data. The further data may comprise
data for updating a
control program 310 running in the controller 300 or operation instructions
for operating the
implantable device 100. The further data may also comprise data sensed by a
sensor 140 connected
to the controller 300.
15 If the analysis was performed by the controller 300, the external device
320 may
continuously request or receive, information of an authentication status of
the connection between
the controller 300 and the external device 320, and upon determining, at the
external device 320,
that the connection is authenticated, transmitting further data from the
external device 320 to the
controller 300.
20 If the analysis was performed by the external device 320, the controller
300 may
continuously request or receive, information of an authentication status of
the connection between
the controller 300 and the external device 320, and upon determining, at the
controller 300, that the
connection is authenticated, transmitting further data from the controller 300
to the external device
320.
25 A main advantage of authenticating a connection according to this method
is that only the
patient may be able to experience the sensation. Thus, only the patient may be
able to authenticate
the connection by providing authentication input corresponding to the
sensation generation.
The sensation generator 381, sensation, sensation components, authentication
data, input
authentication data, and further data may be further described herein. In
these cases, the
30 implantable device 100 and/or external device(s) comprises the necessary
features and functionality
(described in the respective sections of this document). Further information
and definitions can be
found in this document in conjunction with the other aspects.
The method may further comprise transmitting further data between the
controller 300 and
the external device, wherein the further data is used or acted upon, only
after authentication of the
35 connection is performed.
The analysis or step of analyzing may be understood as a comparison or a step
of
comparing.
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In one method, increased security for communication between an external
device(s) and an
implanted controller is provided. Figs. 24b ¨ 24d show an implantable device
100 comprising a
controller 300 and an external device 320 which may form a system.
The controller 300 comprises a transceiver 308, 303 configured to establish a
connection
with an external device 320, i.e. with a corresponding transceiver 328, 323.
The connection may be
an electrical connection Cl using the transceivers 303, 323, or a wireless
connection WL1 using
the transceivers 308, 328. The controller 300 further comprises a computing
unit 306 configured to
verify the authenticity of instructions received at the transceiver 308, 303
from the external device
320. In this aspect, the concept of using previously transmitted instructions
for verifying a currently
transmitted instructions are employed. Consequently, the transmitting node (in
this case the
external device) need to be aware of previously instructions transmitted to
the implant, which
reduces the risk of a malicious device instructing the implant without having
the authority to do so.
In an embodiment, the computing unit 306 is configured to verify the
authenticity of
instructions received at the transceiver 308, 303 by extracting a previously
transmitted set of
instructions from a first combined set of instructions received by the
transceiver. The external
device 320 may thus comprise an external device comprising a computing unit
326 configured for:
combining a first set of instructions with a previously transmitted set of
instructions, forming a
combined set of instructions, and transmitting the combined set of
instructions to the implant. The
previously transmitted set of instructions, or a representation thereof, may
be stored in memory 327
of the external device 320.
The combined set of instructions may have a data format which facilitates such
extraction,
for example including metadata identifying data relating to the previously
transmitted set of
instructions in the combined set of instructions. In some embodiments, the
combined set of
instructions comprises the first set of instructions and a cryptographic hash
of the previously
transmitted set of instructions. Consequently, the method comprises combining,
at the external
device, a first set of instructions with a previously transmitted set of
instructions, forming a first
combined set of instructions. A cryptographic hash function is a special class
of hash function that
has certain properties which make it suitable for use in cryptography. It is a
mathematical algorithm
that maps data of arbitrary size to a bit string of a fixed size (a hash) and
is designed to be a one-
way function, that is, a function which is infeasible to invert. Examples
include MD5, SHAL SHA
256, etc. Increased security is thus achieved.
The first combined set of instructions is then transmitted to the implanted
controller 300,
where it is received by e.g. the transceiver 303, 308. The first combined set
of instructions may be
transmitted to the implant using a proprietary network protocol. The first
combined set of
instructions may be transmitted to the controller 300 using a standard network
protocol. In these
cases, the controller 300 and/or external device(s) comprises the necessary
features and
functionality (described in the respective sections of this document) for
performing transmission of
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data. By using different communication protocols, at the external device 320,
for communication
with the controller 300 and with a second external device 330, an extra layer
of security is added as
the communication between controller 300 and the external device 320 may be
made less directly
accessible to remote third parties.
At the controller 300, the computing unit 306 verifies the authenticity of the
received first
combined set of instructions, by: extracting the previously transmitted set of
instructions from the
first combined set of instructions and comparing the extracted previously
transmitted set of
instructions with previously received instructions stored in the implant.
Upon determining that the extracted previously transmitted set of instructions
equals the
previously received instructions stored in the controller 300, the
authenticity of the received first
combined set of instructions may be determined as valid, and consequently, the
first set of
instructions may be safely run at the controller 300, and the first combined
set of instructions may
be stored in memory 307 of the controller 300, to be used for verifying a
subsequent received set of
instructions.
In some embodiments, upon determining by the internal computing unit 306 that
the
extracted previously transmitted set of instructions differs from the
previously received instructions
stored in the controller 300, feedback related to an unauthorized attempt to
instruct the implantable
device 10may be provided. For example, the transceiver 308, 303 may send out a
distress signal to
e.g. the external device 320 or to any other connected devices. The controller
300 may otherwise
.. inform the patient that something is wrong by e.g. vibration or audio. The
implantable device 100
may be run in safe mode, using a preconfigured control program which is stored
in memory 307 of
the controller 300 and specifically set up for these situations, e.g. by
requiring specific encoding to
instruct the implantable device 100, or only allow a predetermined device
(e.g. provided by the
manufacturer) to instruct the implantable device 100. In some embodiments,
when receiving such
feedback at the external device 320, the external device 320 retransmits the
first combined set of
instructions again, since the unauthorized attempt may in reality be an error
in transmission (where
bits of the combined set of instructions are lost in transmission), and where
the attempt to instruct
the implantable device 100 is indeed authorized.
The step of comparing the extracted previously transmitted set of instructions
with
previously received instructions stored in the controller 300 may be done in
different ways. For
example, the step of comparing the extracted previously transmitted set of
instructions with
previously received instructions stored in the controller 300 comprises
calculating a difference
between the extracted previously transmitted set of instructions with
previously received
instructions stored in the controller 300, and comparing the difference with a
threshold value,
wherein the extracted previously transmitted set of instructions is determined
to equal the
previously received instructions stored in the controller 300 in the case of
the difference value not
exceeding the threshold value. This embodiment may be used when received
instructions is stored
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in clear text, or a representation thereof, in the controller 300, and where
the combined set of
instructions, transmitted from the external device also includes such a
representation of the
previously transmitted instructions. This embodiment may be robust against
error in transmission
where bits of information are lost or otherwise scrambled.
In other embodiments, the combined set of instructions comprises the first set
of
instructions and a cryptographic hash of the previously transmitted set of
instructions, wherein the
method further comprises, at the controller 300, calculating a cryptographic
hash of the previously
received instructions stored in the controller 300 and comparing the
calculated cryptographic hash
to the cryptographic hash included in the first combined set of instructions.
This embodiment
provides increased security since the cryptographic hash is difficult to
decode or forge.
The above way of verifying the authenticity of received instructions at the
controller 300
may be iteratively employed for further sets if instructions.
To further increase security, the transmission of a first set of instructions,
to be stored at the
controller 300 for verifying subsequent sets of combined instructions, where
each set of received
combined instructions will comprise data which in some form will represent, or
be based on, the
first set of instruction, may be performed.
In one example, the external device 320 may be adapted to communicate with the
controller 300 using two separate communication methods. A communication range
of a first
communication method WL1 may be less than a communication range of a second
communication
method WL2. A method may comprise the steps of: sending a first part of a key
from the external
device 320 to the controller 300, using the first communication method WL1 and
sending a second
part of the key from the external device 320 to the controller 300, using the
second communication
method WL2. The method may further comprise deriving, in the controller 300, a
combined key
from the first part of the key and the second part of the key and decrypting
the encrypted data, in
the controller 300, using the combined key. The encrypted data may also be
sent from the external
device 320 to the controller 300 using the second communication method WL2.
The method may
then further comprise confirming an electrical connection Cl between the
controller 300 and the
external device 320 and as a result of the confirmation, decrypting the
encrypted data in the
controller 300 and using the decrypted data for instructing the controller
300.
The method may also comprise placing a conductive member 321, configured to be
in
connection with the external device 320, in electrical connection with a skin
of the patient for
conductive communication with the controller 300. By means of the electrical
connection an extra
layer of security is added as a potential hacker would have to be in contact
with the patient to
access or affect the operation of the implantable device 100.
Using a plurality of communication methods, may increase the security of the
authentication and the communication with the implantable device 100 as more
than one channel
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for communication may need to be hacked or hijacked by an unauthorized entity
to gain access to
the implantable device 100 or the communication.
The electrical connection Cl the conductive member 321 and conductive
communication
may be further described herein in the general definitions section. In these
cases, the controller 300
and/or external device 320 comprise the necessary features and functionality
(described in the
respective sections of this document).
It should also be noted that any one of the first and second communication
methods WL1,
WL2 may be needed to be confirmed in order to decrypt the encrypted data in
the controller 300
and using the decrypted data for instructing the implantable device 100.
1 0 The method may further comprise the step of wirelessly receiving, at
the controller 300, a
third part of the key from the second external device 330. In this case, the
combined key may be
derived from the first part of the key, the second part of the key and the
third part of the key.
The first communication method WL1 may be a wireless form of communication.
The first
communication method WL1 may preferably be a form of electromagnetic or radio-
based
1 5 communication however, other forms of communication are not excluded.
The first communication
method WL1 may comprise or be related to the items of the following list:
Radio-frequency
identification (RFID), Bluetooth, Bluetooth 5, Bluetooth Low Energy (BLE),
Near Field
Communication (NFC), NFC-V, Infrared (IR) based communication, Ultrasound
based
communication.
20 RFID communication may enable the use of a passive receiver circuit such
as those in a
RFID access/key or payment card. IR based communication may comprise fiber
optical
communication and IR diodes. IR diodes may alternatively be used directly,
without a fiber, such
as in television remote control devices. Ultrasound based communication may be
based on the non-
invasive, ultrasound imaging found in use for medical purposes such as
monitoring the
25 development of mammal fetuses.
The first communication method WL1 may use a specific frequency band. The
frequency
band of the first communication method WL1 may have a center frequency of
13.56 MHz or 27.12
MHz. These bands may be referred to as industrial, scientific and medical
(ISM) radio bands. Other
ISM bands not mentioned here may also be utilized for the communication
methods WL1, WL2. A
30 bandwidth of the 13.56 MHz centered band may be 14 kHz and a bandwidth
of the 27.12 MHz
centered band may be 326 kHz.
The communication range of the first communication method WL1 may be less than
10
meters, preferably less than 2 meters, more preferably less than 1 meter and
most preferably less
than 20 centimeters. The communication range of the first communication method
WL1 may be
35 limited by adjusting a frequency and/or a phase of the communication.
Different frequencies may
have different rates of attenuation. By implementing a short communication
range of the first
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communication method, security may be increased since it may be ensured or
made probable that
the external device is under control of the patient (holding the external
device close to the implant)
The communication range of the first communication method WL1 should be
evaluated by
assuming that a patient's body, tissue, and bones present the propagation
medium. Such a
5 propagation medium may present different attenuation rates as compared to
a free space of an air-
filled atmosphere or a vacuum.
By restricting the communication range, it may be established that the
external device
communicating with the implanted controller 300 is in fact on, or at least
proximal to, the patient.
This may add extra security to the communication.
10 The second communication method WL2 may be a wireless form of
communication. The
second communication method WL2 may preferably be a form of electromagnetic or
radio-based
communication. The second communication method WL2 may be based on
telecommunication
methods. The second communication method WL2 may comprise or be related to the
items of the
following list: Wireless Local Area Network (WLAN), Bluetooth, Bluetooth 5,
BLE, GSM or 2G
15 .. (2nd generation cellular technology), 3G, 4G, 5G.
The second communication method WL2 may utilize the ISM bands as mentioned in
the
above for the first communication method WL1.
A communication range of the second communication method WL2 may be longer
than the
communication range of the first communication method WL1. The communication
range of the
20 second communication method WL2 may preferably be longer than 10 meters,
more preferably
longer than 50 meters, and most preferably longer than 100 meters.
Encrypted data may comprise instructions for updating a control program 310
running in
the implantable device 100. Encrypted data may further comprise instructions
for operating the
implantable device 100.
25 In one embodiment, the implantable device 100 may transmit data to an
external device
320 which may add an additional layer of encryption and transmit the data to a
second external
device 330, described with reference to figs. 24b ¨ 24d. By having the
external device add an
additional layer of encryption, less computing resources may be needed in the
implanted controller
300, as the controller 300 may transmit unencrypted data or data encrypted
using a less secure or
30 less computing resource requiring encryption. In this way, data can
still be relatively securely
transmitted to a third device. The transmission of data can be performed using
any of the method
described herein in addition to the method or in the system described below.
Thus, in an embodiment, a system is provided. The system comprises an
implantable
device 100 according to any of the preceding embodiments disclosed in for
instance figures 4-11,
35 comprising a controller 300 configured to transmit data from the body of
the patient to an external
device 320, and an encryption unit 382 for encrypting the data to be
transmitted. The system further
comprises an external device 320 configured to receive the data transmitted by
the controller 300,
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encrypt the received data using a first key and transmit the encrypted
received data to a third
external device 330. The encryption can be performed using any of the keys
described above or
below. In some embodiments, the external device 320 is configured to decrypt
the data received
from the controller 300 before encrypting and transmitting the data.
Alternatively, the external
device 320 may encrypt and transmit the data received from the controller 300
without decrypting
it first.
In one example, the encryption unit 382 is configured to encrypt the data to
be transmitted
using a second key. The first key or the second key may, for example,
information specific to the
implantable device 100, a secret key associated with the external device 320,
an identifier of the
implantable device 100 or an identifier of the controller 300. The second key
could be a key
transmitted by the external device 320 to the controller 300. In some
examples, the second key is a
combined key comprising a third key received by the controller 300 from the
external device 320.
The first key may be a combined key comprising a fourth key, wherein the
fourth key is
received by the external device 320 from a fourth device. The fourth device
may be a verification
unit, either comprised in the external device, or external to the external
device and connected to it.
The verification unit may have a sensor 350 for verification, such as a
fingerprint sensor. More
details in regard to this will be described below. Alternatively, the
verification unit may be a
generator, as described above.
The system may be configured to perform a method for transmitting data using a
sensed
parameter. The method may comprise transmitting a parameter measured by the
external device
320 from the external device 320 to the controller 300. In this case, the
comparison of the
parameter of the patient measured by the external device 320 and the parameter
of the patient
measured by the controller 300 may be performed by the controller 300. The
implantable device
100 may comprise a first sensor 140 for measuring the parameter of the patient
at the implantable
device 100. The external device 320 may comprise an external sensor 350 for
measuring the
parameter of the patient at the external device 320.
Authentication of the connection between the controller 300 and the external
device 320
may be performed automatically without input, authentication, or verification
from a user or
patient. This is because the comparison of parameters measured internally and
externally, by the
internal and external sensors 351, 350 respectively may be enough to
authenticate the connection.
This may typically be the case when the parameter of the patient is related to
an automatically
occurring physiological function of the patient such as e.g. a pulse of the
patient. Certain types of
authentication may however require actions from the patient, e.g. having the
patient perform
specific movements.
In the embodiments described herein, the controller 300 may comprise or be
connected to a
sensation generator 381 as described above. In response to an event in the
implant, such as a reset,
a restart, receipt of new instructions, receipt of a new configuration or
update, installation or
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activation of new instructions or configuration or update, the controller 300
may be configured to
cause the sensation generator 381 to generate a sensation detectable by the
patient in which the
implantable device 100 is implanted. In some examples, the user may after the
sensation verify an
action, for example via a user interface of an external device 320.
The implantable device 100 may further implement a method for improving the
security of
the data transmitted from the controller 300. The method, for encrypted
communication between a
controller 300, when implanted in a patient's body, and an external device
320, comprises encoding
or encrypting, by the controller 300 or a processor 306 comprised in or
connected to the controller
300, data relating to the implantable device 100 or the operation thereof;
transmitting, by the
controller 300, the data; receiving, by a second communication unit comprised
the external device
320, the data; encrypting, by the external device 320, the data using an
encryption key to obtain
encrypted data; and transmitting the encrypted data to a third external device
330. In this way, the
external device 320 may add or exchange the encryption, or add an extra layer
of encryption, to the
data transmitted by the controller 300. When the controller 300 encodes the
data to be transmitted it
may be configured to not encrypt the data before transmitting, or only using a
lightweight
encryption, thus not needing as much processing power as if the controller
were to fully encrypt the
data before the transmission.
The encrypting, by the controller 300, may comprise encrypting the data using
a second
key. The encryption using the second key may be a more lightweight encryption
than the
encryption performed by the external device using the second key, i.e. an
encryption that does not
require as much computing resources as the encryption performed by the
external device 320.
The first or the second key may comprise a private key exchanged as described
above with
reference to encryption and authentication, or the first or the second key may
comprise an
information specific to the implantable device 100, a secret key associated
with the external
device, an identifier of the implantable device 100 or an identifier of the
controller 300. They may
be combined keys as described in this description, and the content of the
keys, any combination of
keys, and the exchange of a key or keys is described in the encryption and/or
authentication
section.
According to one embodiment described with reference to fig. 24b-d, the
communication
unit 102 or internal controller 102 or control unit 102 comprises a wireless
transceiver 108 for
communicating wirelessly with an external device, a security module 189, and a
central unit, also
referred to herein as a computing unit 106, which is to be considered as
equivalent. The central unit
106 is configured to be in communication with the wireless transceiver 108,
the security module
189 and the implantable medical device or active unit 101. The wireless
transceiver 108 is
configured to receive communication from the external device 200 including at
least one
instruction to the implantable medical device 100 and transmit the received
communication to the
central unit or computing unit 106. The central unit or computing unit 106 is
configured to send
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secure communication to the security module 189, derived from the received
communication from
the external device 200, and the security module 189 is configured to decrypt
at least a portion of
the secure communication and verify the authenticity of the secure
communication. The security
module is further configured to transmit a response communication to the
central unit or computing
unit 106 and the central unit or computing unit is configured to communicate
the at least one
instruction to the active unit 101. In the embodiment shown in fig. 24b ¨ 24d,
the at least one
instruction is based on the response communication, or a combination of the
response
communication and the received communication from the external device 200.
In the embodiment shown in fig. 24b-24d, the security module 189 comprises a
set of rules
for accepting communication from the central unit or computing unit 106. In
the embodiment
shown in fig. 24b-24d, the wireless transceiver 108 is configured to be able
to be placed in an off-
mode, in which no wireless communication can be transmitted or received by the
wireless
transceiver 108. The set of rules comprises a rule stipulating that
communication from the central
unit or computing unit 106 to the security module 189 or to the active unit
101 is only accepted
.. when the wireless transceiver 108 is placed in the off-mode.
In the embodiment shown in fig. 24b-24d, the set of rules comprises a rule
stipulating that
communication from the central unit or computing unit 106 is only accepted
when the wireless
transceiver 108 has been placed in the off-mode for a specific time period.
In the embodiment shown in fig. 24b-24d, the central unit or computing unit
106 is
configured to verify a digital signature of the received communication from
the external device
200. The digital signature could be a hash-based digital signature which could
be based on a
biometric signature from the patient or a medical professional. The set of
rules further comprises a
rule stipulating that communication from the central unit 106 is only accepted
when the digital
signature of the received communication has been verified by the central unit
106. The verification
could for example comprise the step of comparing the digital signature or a
portion of the digital
signature with a previously verified digital signature stored in the central
unit 106. The central unit
106 may be configured to verify the size of the received communication from
the external device
and the set of rules could comprise a rule stipulating that communication from
the central unit 106
is only accepted when the size of the received communication has been verified
by the central unit
106. The central unit could thus have a rule stipulating that communication
above or below a
specified size range is to be rejected.
In the embodiment shown in fig. 24b-24d, the wireless transceiver is
configured to receive
a message from the external device 200 being encrypted with at least a first
and second layer of
encryption. The central unit 106 the decrypts the first layer of decryption
and transmit at least a
portion of the message comprising the second layer of encryption to the
security model 189. The
security module 189 then decrypts the second layer of encryption and transmits
a response
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communication to the central unit 106 based on the portion of the message
decrypted by the
security module 189.
In the embodiment shown in fig. 24b-24d, the central unit 106 is configured to
decrypt a
portion of the message comprising a digital signature, such that the digital
signature can be verified
by the central unit 106, also the central unit 106 is configured to decrypt a
portion of the message
comprising message size information, such that the message size can be
verified by the central unit
106.
In the embodiment shown in fig. 24b-24d, the central unit 106 is configured to
decrypt a
first and second portion of the message, and the first portion comprises a
checksum for verifying
the authenticity of the second portion.
In the embodiment shown in fig. 24b-24d, the response communication
transmitted from
the security module 189 comprises a checksum, and the central unit 106 is
configured to verify the
authenticity of at least a portion of the message decrypted by the central
unit 106 using the received
checksum, i.e. by adding portions of the message decrypted by the central unit
106 and comparing
the sum to the checksum.
In the embodiment shown in fig. 24c-24d, the set of rules further comprise a
rule related to
the rate of data transfer between the central unit 106 and the security module
189. The rule could
stipulate that the communication should be rejected or aborted if the rate of
data transfer exceeds a
set maximum rate of data transfer, which may make it harder for unauthorized
persons to inject
malicious code or instructions to the medical implant.
In the embodiment shown in fig. 24b-24d, the security module 189 is configured
to decrypt
a portion of the message comprising the digital signature being encrypted with
the second layer of
encryption, such that the digital signature can be verified by the security
module 189. The security
module 189 then transmits a response communication to the central unit 106
based on the outcome
of the verification, which can be used by the central unit 106 for further
decryption of the message
or for determining if instructions in the message should be communicated to
the active unit 101.
In the embodiment shown in fig. 24b-24d, the central unit 106 is only capable
of
decrypting a portion of the received communication from the external device
200 when the wireless
transceiver 108 is placed in the off-mode. In the alternative, or as an
additional layer of security,
the central unit 106 may be limited such that the central unit 106 is only
capable of communicating
instructions to the active unit 101 of the implantable medical device 100 when
the wireless
transceiver 108 is placed in the off-mode. This ensures that no attacks can
take place while the
central unit 106 is communicating with the active unit 101.
In the embodiment shown in fig. 24b-24d, the implantable controller 102 is
configured to
receive, using the wireless transceiver 108, a message from the external
device 200 comprising a
first un-encrypted portion and a second encrypted portion. The implantable
controller 102 (e.g. the
central unit 106 or the security module 189) then decrypts the encrypted
portion, and uses the
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decrypted portion to verify the authenticity of the un-encrypted portion. As
such, computing power
and thereby energy can be saved by not encrypting the entire communication,
but rather only the
portion required to authenticate the rest of the message (such as a checksum
and/or a digital
signature)
5 In the embodiment shown in fig. 24b-24d, the central unit 106 is
configured to transmit an
encrypted portion to the security module 189 and receive a response
communication from the
security module 189 based on information contained in the encrypted portion
being decrypted by
the security module. The central unit 106 is then configured to use the
response communication to
verify the authenticity of the un-encrypted portion. The un-encrypted portion
could comprise at
10 least a portion of the at least one instruction to the implantable
medical device 106.
In the embodiment shown in fig. 24b-24d, the implantable controller 102 is
configured to
receive, using the wireless transceiver 108, a message from the external
device 200 comprising
information related to at least one of: a physiological parameter of the
patient and a physical
parameter of the implanted medical device 100, and use the received
information to verify the
15 authenticity of the message. The physiological parameter of the patient
could be a parameter such
as a parameter based on one or more of: a temperature, a heart rate and a
saturation value.
The physical parameter of the implanted medical device 100 could comprise at
least one of
a current setting or value of the implanted medical device 100, a prior
instruction sent to the
implanted medical device 100 or an ID of the implanted medical device 100.
20 The portion of the message comprising the information related to the
physiological
parameter of the patient and/or physical or functional parameter of the
implanted medical device
100 could be encrypted, and the central unit 106 may be configured to transmit
the encrypted
portion to the security module 189 and receive a response communication from
the security module
189 based on the information having been decrypted by the security module 189.
25 In the embodiment shown in fig. 24b-24d, the security module 189 is a
hardware security
module comprising at least one hardware-based key. The security module 189 may
have features
that provide tamper evidence such as visible signs of tampering or logging and
alerting. It may also
be so that the security module 189 is "tamper resistant", which makes the
security module 189
inoperable in the event that tampering is detected. For example, the response
to tampering could
30 include deleting keys is tampering is detected. The security module 189
could comprise one or
more secure cryptoprocessor chip. The hardware-based key(s) in the security
module 189 could
have a corresponding hardware-based key placeable in the external device 200.
The corresponding
external hardware-based key could be placed on a key-card connectable to the
external device 200.
In alternative embodiments, the security module 189 is a software security
module
35 comprising at least one software-based key, or a combination of a
hardware and software-based
security module and key. The software-based key may correspond to a software-
based key in the
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external device 200. The software-based key may correspond to a software-based
key on a key-
card connectable to the external device 200.
In the embodiment shown in fig. 24b-24d, the external device 200 is a handheld
external
device, however, in alternative embodiments, the external device may be a
remote external device
or a cloud based external device
In the embodiment shown in fig. 24b-24d, the at least one instruction to the
implantable
medical device 100 comprises an instruction for changing an operational state
of the implantable
medical device 100.
In the embodiment shown in fig. 24b-24d, the wireless transceiver 108 is
configured to
communicate wirelessly with the external 200 device using electromagnetic
waves at a frequency
below 100 kHz, or more specifically below 40 kHz. The wireless transceiver 108
is thus configured
to communicate with the external device 200 using "Very Low Frequency"
communication (VLF).
VLF signals have the ability to penetrate a titanium housing of the
implantable medical device 100,
such that the electronics of the implantable medical device 100 can be
completely encapsulated in a
titanium housing.
The wireless transceiver 108 is configured to communicate wirelessly with the
external
device 200 using a first communication protocol and the central unit 106 is
configured to
communicate with the security module 189 using a second, different,
communication protocol.
This adds an additional layer of security as security structures could be
built into the electronics
and/or software in the central unit 106 enabling the transfer from a first to
a second communication
protocol. The wireless transceiver 108 may be configured to communicate
wirelessly with the
external device using a standard network protocol, which could be one of an
RFID type protocol, a
WLAN type protocol,a Bluetooth (BT) type protocol,a BLE type protocol,an NFC
type protocol, a
3G/4G/5G type protocol, and a GSM type protocol. In the alternative, or as a
combination, the
wireless transceiver 108 could be configured to communicate wirelessly with
the external device
200 using a proprietary network protocol. The wireless transceiver 108 could
comprises a Ultra-
Wide Band (UWB) transceiver and the wireless communication between the
implantable controller
102 and the external device 200 could thus be based on UWB. The use of UWB
technology enables
positioning of the remote control 320" which can be used by the implanted
medical device 100 as
a way to establish that the external device 200 is at a position which the
implanted medical device
100 and/or the patient can acknowledge as being correct, e.g. in the direct
proximity to the medical
device 100 and/or the patient, such as within reach of the patient and/or
within 1 or 2 meters of the
implanted medical device 100. In the alternative, a combination of UWB and BT
could be used, in
which case the UWB communication can be used to authenticate the BT
communication, as it is
easier to transfer large data sets using BT.
According to one embodiment described with reference to fig. 24b-24d, the
communication
unit 102 or controller of the implantable medical device 100 comprises a
receiving unit 105 or
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energy receiver 105 comprising a coil 192 (specifically shown in fig. 113B')
configured for
receiving transcutaneously transferred energy. The receiving unit further
comprises a measurement
unit 194 configured to measure a parameter related to the energy received by
the coil 192 and a
variable impedance 193 electrically connected to the coil 192. The receiving
unit 105 further
comprises a switch 195a placed between the variable impedance 193 and the coil
192 for switching
off the electrical connection between the variable impedance 193 and the coil
192. The
communication unit 102 or controller 102 is configured to control the variable
impedance 193 for
varying the impedance and thereby tune the coil 192 based on the measured
parameter. The
communication unit 102 or controller 102 is further configured to control the
switch 195a for
switching off the electrical connection between the variable impedance 193 and
the coil 192 in
response to the measured parameter exceeding a threshold value. The controller
102 may further be
configured to vary the variable impedance in response to the measured
parameter exceeding a
threshold value. As such, the coil can be tuned or turned off to reduce the
amount of received
energy if the amount of received energy becomes excessive. The measurement
unit 194 is
configured to measure a parameter related to the energy received by the coil
192 over a time period
and/or measure a parameter related to a change in energy received by the coil
192 by for example
measure the derivative of the received energy over time. The variable
impedance 193 is in the
embodiment shown in fig. 24c' placed in series with the coil 192. In
alternative embodiments it is
however conceivable that the variable impedance is placed parallel to the coil
192.
The first switch 195a is placed at a first end portion 192a of the coil 192,
and the
implantable medical device 100 further comprises a second switch 195b placed
at a second end
portion of the coil 192, such that the coil 192 can be completely disconnected
from other portions
of the implantable medical device 100. The receiving unit 105 is configured to
receive
transcutaneously transferred energy in pulses according to a pulse pattern.
The measurement unit
194 is in the embodiment shown in fig. 24c' configured to measure a parameter
related to the pulse
pattern. The controller 102 is configured to control the variable impedance in
response to the pulse
pattern deviating from a predefined pulse pattern. The controller 102 is
configured to control the
switch 195a for switching off the electrical connection between the variable
impedance 193 and the
coil 192 in response to the pulse pattern deviating from a predefined pulse
pattern. The
measurement unit is configured to measure a temperature in the implantable
medical device 100 or
in the body of the patient, and the controller 102 is configured to control
the first and second switch
195a,195b in response to the measured temperature.
The variable impedance 193 may comprise a resistor and a capacitor and/or a
resistor and
an inductor and/or an inductor and a capacitor. The variable impedance 193 may
comprise a
digitally tuned capacitor or a digital potentiometer. The variable impedance
193 may comprise a
variable inductor. The first and second switch comprises a semiconductor, such
as a MOSFET. The
variation of the impedance is configured to lower the active power that is
received by the receiving
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unit. As can be seen in fig. 24c', the variable impedance 193, the first and
second switch 195a,195b
and the measurement unit 194 are connected to the communication
unit/controller 102 and the
receiving unit 105 is connected to an energy storage unit 10 such that the
energy storage unit 10
can store energy received by the receiving unit 105.
In an embodiment, the implantable device 100 comprises at least one sensor for
sensing at
least one physiological parameter of the patient or a functional parameter of
the implantable device
100, as described with reference to figs. 24b ¨ 24d. The sensor 351 may, for
example, be a
pressure sensor, an electrical sensor, a clock, a temperature sensor, a motion
sensor, an optical
sensor, a sonic sensor, an ultrasonic sensor. The sensor 351 is configured to
periodically sense the
.. parameter and the controller 300 is configured to, in response to the
sensed parameter being above
a predetermined threshold, wirelessly broadcast information relating to the
sensed parameter. The
controller 300 may be configured to broadcast the information using a short to
mid-range
transmitting protocol, such as a Radio Frequency type protocol, a RFID type
protocol, a WLAN
type protocol, a Bluetooth type protocol, a BLE type protocol, a NFC type
protocol, a 3G/4G/5G
.. type protocol, or a GSM type protocol.
The controller of the implant may be connected to the sensor 351 and be
configured to
anonymize the information before it is transmitted. The transmission of data
may also be called
broadcasting of data.
In addition to or as an alternative to transmitting the data when the sensed
parameter is
.. above a predetermined threshold, the controller 300 may be configured to
broadcast the
information periodically. The controller 300 may be configured to broadcast
the information in
response to a second parameter being above a predetermined threshold. The
second parameter may,
for example, be related to the controller 300 itself, such as a free memory or
free storage space
parameter, or a battery status parameter. When the implantable device 100
comprises an
implantable energy storage unit and an energy storage unit indicator, the
energy storage unit
indicator is configured to indicate a functional status of the implantable
energy storage unit and the
indication may be comprised in the transmitted data. The functional status may
indicate at least one
of charge level and temperature of the implantable energy storage unit.
In some embodiments the external device 320 is configured to receive the
broadcasted
information, encrypt the received information using an encryption key and
transmit the encrypted
received information. In this way, the external device 320 may add an
additional layer of
encryption or exchange the encryption performed by the controller 300.
In an embodiment, the controller 300 is configured to transmit the data using
the body of
the patient as a conductor Cl, and the external device 320 is configured to
receive the data via the
body. Alternatively, or in combination, the controller 300 of the implant is
configured to transmit
the data wirelessly to the external device WL2.
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Thus, the controller 300 may implement a method for transmitting data from the
controller
300 comprising a processor 306, comprising: obtaining sensor measurement data
via a sensor 140
connected to or comprised in the controller 300, the sensor measurement
relating to at least one
physiological parameter of the patient or a functional parameter of the
implantable device 100, and
transmitting by the controller 300 the sensor measurement data in response to
the sensor
measurement being above a predetermined threshold, wherein the sensor 140 is
configured to
periodically sense the parameter. The method may further comprise broadcasting
the sensor
measurement data, to be received by an external device 320. The transmitting
or broadcasting may
comprise using at least one of a Radio Frequency type protocol, RFID type
protocol, WLAN type
protocol, Bluetooth type protocol, BLE type protocol, NFC type protocol,
3G/4G/5G type protocol,
or a GSM type protocol.
The method may further comprise, at the processor 306, anonymizing, by the
processor, the sensor measurement data before it is transmitted, or encrypting
the sensor
measurement data, using an encryptor 382 comprised in the processing unit 306,
before it is
transmitted. The transmitting of the data may further comprise to encode the
data before the
transmitting. The type of encoding may be dependent on the communication
channel or the
protocol used for the transmission.
The transmitting may be performed periodically, or in response to a signal
received by the
processor, for example, by an internal part of the implantable device 100 such
as a sensor 140, or
by an external device 320.
The parameter may, for example, be at least one of a functional parameter of
the
implantable device 100 (such as a battery parameter, a free memory parameter,
a temperature, a
pressure, an error count, a status of any of the control programs, or any
other functional parameter
mentioned in this description) or a parameter relating to the patient (such as
a temperature, a blood
pressure, or any other parameter mentioned in this description). In one
example, the implantable
device 10 comprises an implantable energy storage unit 40 and an energy
storage unit indicator
304c, and the energy storage unit indicator 304c is configured to indicate a
functional status of the
implantable energy storage unit 40, and the sensor measurement comprises data
related to the
energy storage unit indicator.
In one example, the transmitting comprises transmitting the sensor measurement
to an
internal processor 306 configured to cause a sensation generator 381 to cause
a sensation detectable
by the patient in which the implant 100 is implanted.
The method may be implemented in a system comprising the implant 100 as shown
in for
instance figures 4-11 and an external device 320, and further comprise
receiving the sensor
measurement data at the external device 320, and, at the external device 320,
encrypting the sensor
measurement data using a key to obtain encrypted data, and transmitting the
encrypted data. The
transmitting may, for example, be performed wirelessly WL3 or conductively Cl.
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100
In the examples or embodiments transmitting data from or to the implantable
device 100,
the following method may be implanted in order to verify the integrity of the
data, described with
reference to figs. 24b ¨ 24c. By verifying the integrity of the data, an
external device 320 or a
processor 306 comprised in the controller 300 may verify that the data has not
been corrupted or
tampered with during the transmission. In some examples, data integrity for
data communicated
between a controller 300 and an external device 320 or between an external
device 320 and the
controller 300 may be performed using a cyclic redundancy check.
Thus, in a first example, a method for evaluating a parameter of a controller
300 implanted
in a patient is described. The controller 300 comprises a processor 306 and a
sensor 140 for
measuring the parameter. The method comprises measuring, using the sensor 140,
the functional
parameter to obtain measurement data; establishing a connection between the
internal controller
300 and an external device 320 configured to receive data from the implant;
determining, by the
processor 306, a cryptographic hash or a metadata relating to the measurement
data and adapted to
be used by the external device 320 to verify the integrity of the received
data; transmitting the
cryptographic hash or metadata; and transmitting, from the controller 300, the
measurement data.
The parameter may, for example, be a parameter of the controller 300, such as
a
temperature, a pressure, a battery status indicator, a time period length,
pressure at a constriction
device, a pressure at a sphincter, or a physiological parameter of the
patient, such as a pulse, a
blood pressure, or a temperature. In some examples, multiple parameters may be
used.
The method may further comprise evaluating the measurement data relating to
the
functional parameter. By evaluating it may be meant to determine if the
parameter is exceeding or
less than a predetermined value, to extract another parameter from the
measurement data, compare
the another parameter to a predetermined value, or displaying the another
parameter to a user. For
example, the method may further comprise, at the external device 320, to
determining, based on the
evaluating, that the implantable device 100 is functioning correctly, or
determining based on the
evaluating that the implantable device 100 is not functioning correctly.
If it is determined that the implantable device 100 is not functioning
correctly, the method
may further comprise sending, from the external device 320, a corrective
command to the
controller 300, receiving the corrective command at the controller 300, and by
running the
corrective command correcting the functioning of the implantable device 100
according to the
corrective command.
The method may further comprise, at the external device 320, receiving the
transmitted
cryptographic hash or metadata, receiving the measurement data, and verifying
the integrity of the
measurement data using the cryptographic hash or metadata. The cryptographic
hash algorithm be
any type of hash algorithm, i.e. an algorithm comprising a one-way function
configured to have an
input data of any length as input and produce a fixed-length hash value. For
example, the
cryptographic hash algorithm may be MD5, SHAl, SHA 256, etc.
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In some examples, the cryptographic hash is a signature obtained by using a
private key of
the controller 300, and wherein the verifying, by the external device 320,
comprises verifying the
signature using a public key corresponding to the private key.
When using a cryptographic hash, the method may further comprise calculating a
second
cryptographic hash for the received measurement data using a same
cryptographic hash algorithm
as the processor, and determining that the measurement data has been correctly
received based on
that the cryptographic hash and the second cryptographic hash are equal (i.e.
have the same value).
When using a metadata, the verifying the integrity of the data may comprises
obtaining a
second metadata for the received measurement data relating to the functional
parameter, and
determining that the data has been correctly received based on that metadata
and the second
metadata are equal. The metadata may, for example, be a length of the data or
a timestamp. In some
examples the measurement data is transmitted in a plurality of data packets.
In those examples, the
cryptographic hash or metadata comprises a plurality of cryptographic hashes
or metadata each
corresponding to a respective data packet, and the transmitting of each the
cryptographic hashes or
metadata is performed for each of the corresponding data packets.
A similar method may be utilized for communicating instructions from an
external device
320 to a controller 300 implanted in a patient. The method comprises
establishing a first connection
between the external device 320 and the controller 300, establishing a second
connection between a
second external device 330 and the controller 300, transmitting, from the
external device 320, a
first set of instructions to the controller 300 over the first connection,
transmitting, from the second
external device 330, a first cryptographic hash or metadata corresponding to
the first set of
instructions to the controller 300, and, at the controller 300, verifying the
integrity of the first set of
instructions and the first cryptographic hash or metadata, based on the first
cryptographic hash or
metadata. The external device 320 may be separate from the second external
device 330.
The first connections may be established between the controller 300 and a
transceiver of
the external communication unit 323. In some examples, the communication using
the second
connection is performed using a different protocol than a protocol used for
communication using
the first communication channel. In some examples, the first connection is a
wireless connection
and the second connection is an electrical connection. The second connection
may, for example, be
an electrical connection using the patient's body as a conductor (using 321).
The protocols and
ways of communicating may be any communication protocols described in this
description with
reference to Cl, and WL1-WL4. The establishing of the first and second
connections are performed
according to the communication protocol used for each of the first and the
second connections.
When using a cryptographic hash, the verifying the integrity of the first set
of instructions
may comprise calculating a second cryptographic hash for the received first
set of instructions
using a same cryptographic hash algorithm as the processor 306 and determining
that the first set of
instructions has been correctly received based on that the cryptographic hash
and the second
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cryptographic hash are equal. The cryptographic hash may, for example, be a
signature obtained by
using a private key of the implantable device 100, and wherein the verifying
comprises verifying
the signature using a public key corresponding to the private key. In some
examples, the
cryptographic hash is a signature obtained by using a private key of the
implantable device 100,
and wherein the verifying comprises verifying the signature using a public key
corresponding to the
private key. The private keys and public keys, as well as the exchange or
transmittal of keys have
been described in this description. Alternatively, other well-known methods
can be used for
transmitting or exchanging a key or keys between the external device 320 and
the controller 300.
When using a metadata, and wherein the verifying the integrity of the data may
comprise
obtaining a second metadata for the received first set of instructions and
determining that the first
set of instructions has been correctly received based on that metadata and the
second metadata are
equal. The metadata may, for example, be any type of data relating to the data
to be transmitted, in
this example the first set of instructions. For example, the metadata may be a
length of the data to
be transmitted, a timestamp on which the data was transmitted or retrieved or
obtained, a size, a
.. number of packets, or a packet identifier.
In some examples, the controller 300 may transmit data to an external device
320 relating
to the data information in order to verify that the received data is correct.
The method may thus
further comprise, transmitting, by the controller 300, information relating to
the received first set of
instructions, receiving, by the external device 320, the information, and
verifying, by the external
.. device 320, that the information corresponds to the first set of
instructions sent by the external
device 320. The information may, for example, comprise a length of the first
set of instructions.
The method may further comprise, at the controller 300, verifying the
authenticity of the
first set of instructions by i. calculating a second cryptographic hash for
the first set of instructions,
ii. comparing the second cryptographic hash with the first cryptographic hash,
iii. determining that
the first set of instructions are authentic based on that the second
cryptographic hash is equal to the
first cryptographic hash, and upon verification of the authenticity of the
first set of instructions,
storing them at the controller 300.
In some examples, the first set of instructions comprises a cryptographic hash
corresponding to a previous set of instruction, as described in other parts of
this description.
In some examples, the first set of instructions may comprise a measurement
relating to the
patient of the body for authentication, as described in other parts of this
description.
A system and a method for communication of instructions or control signals
between an
external device 320 and an implant 100 will now be described with reference to
Figs. 24b-c.
The system shown in Figs. 24b-c comprises an implantable device 100, a first
external
device 320, and a second external device 330. The implant comprises a
controller 300 and an
implantable constriction device 302, such as a sensor. The controller 300 is
adapted to receive an
instruction from an external device 320 over the communication channel WL1, Cl
and run the
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instruction to control a function of the implant 100, such as a function of
the implantable device
100. The communication channel WL1, Cl may be any type of communication
channel, such as a
wireless connection WL1 or a conductive connection Cl described herein. For
example, the
wireless connection may comprise at least one of the following protocols:
Radio Frequency type
protocol, RFID type protocol, WLAN type protocol, Bluetooth type protocol, a
BLE type protocol,
a NFC type protocol, a 3G/4G/5G/6G type protocol, a GSM type protocol, and/or
Bluetooth 5.
The first external device 320 is adapted to receive, such as through a user
interface, or
determine an instruction to be transmitted to the implant 100. The
determination of the instruction
may, for example, be based on received data from the implantable device 100,
such as
measurement data or data relating to a state of the implant, such as a battery
status or a free
memory status. The first external device 320 may be any type of device capable
of transmitting
information to the implant and capable of determining or receiving an
instruction to be transmitted
to the implantable device 100. In a preferred embodiment, the first external
device 320 is a hand-
held device, such as a smartphone, smartwatch, tablet etc. handled by the
patient, having a user
interface for receiving an instruction from a user, such as the patient or a
caregiver.
The first external device 320 is further adapted to transmit the instruction
to a second
external device 330 via communication channel WL3. The second external device
320 is adapted to
receive the instruction, encrypt the instruction using an encryption key, and
then transmit the
encrypted instruction to the implantable device 100. The implantable device
100 is configured to
receive the instruction at the controller 300. The controller 300 thus
comprises a wired transceiver
or a wireless transceiver for receiving the instruction. The implantable
device 100 is configured to
decrypt the received instruction. The decryption may be performed using a
decryption key
corresponding to the encryption key. The encryption key, the decryption key
and methods for
encryption/decryption and exchange of keys may be performed as described in
the "general
definition of features" or as described with reference to Figs. 24b-c.
Further, there are many known
methods for encrypting data which the skilled person would understand to be
usable in this
example.
The second external device 330 may be any computing device capable of
receiving,
encrypting and transmitting data as described above. For example, the second
external device 320
may be a network device, such as a network server, or it may be an encryption
device
communicatively coupled to the first external device.
The instruction may be a single instruction for running a specific function or
method in the
implantable device 100, a value for a parameter of the implantable device 100,
or a set of sub-steps
to be performed by the controller 300 comprised in the implant.
In this way, the instruction for controlling a function of the implantable
device 100 may be
received at the first external device 320 and transmitted to the implant 100
via the second external
device 330. By having a second external device 330 encrypting the instruction
before transmitting
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it to the implantable device 100, the instruction may be verified by the
second external device 330
and the first external device 320 may function so as to relay the instruction.
In some alternatives,
the second external device 330 may transmit the instruction directly to the
implantable device 100.
This may provide an increased security as the instruction sent to the
implantable device 100 may be
verified by the second external device 330, which, for example, may be a
proprietary device
managed by the medical professional responsible for the implantable device
100. Further, by
having the second medical device 330 verifying and encrypting the instruction,
the responsibility
authenticity and/or correctness of the instruction may lie with the second
external device 330,
which may be beneficial for regulatory purposes, as the first external device
320 may not be
considered as the instructor of the implantable device 100.
Further, the second external device 330 may verify that the instruction is
correct before
encrypting or signing and transmitting it to the implantable device 100. The
second external device
330 may, for example, verify that the instruction is correct by comparing the
instruction with a
predetermined set of instructions, and if the instruction is comprised in the
predetermined set of
instructions determine that the instruction is correct. If the instruction
comprises a plurality of sub-
steps, the second external device 330 may determine that the instruction is
correct if all the sub-
steps are comprised in the predetermined set of instructions. If the
instruction comprises a value for
a parameter of the implantable device 100, the second external device 330 may
verify that the value
is within a predetermined range for the parameter. The second external device
320 may thus
comprise a predetermined set of instructions, or a predetermined interval or
threshold value for a
value of a parameter, stored at an internal or external memory.
The second external device 330 may be configured to reject the instruction,
i.e. to not
encrypt and transmit the instruction to the implantable device 100, if the
verification of the
instruction would fail. For example, the second external device 330 determines
that the instruction
or any sub-step of the instruction is not comprised in the predetermined set
of instructions, or if a
value for a parameter is not within a predetermined interval, the second
external device 330 may
determine that the verification has failed.
In some embodiments, the implantable device 100 may be configured to verify
the
instruction. The verification of the instruction may be performed in the same
way as described with
reference to Figs. 24b-c. If the verification is performed by comparing the
instruction or any sub-
steps of the instruction with a predetermined set of instructions, the
controller 300 may comprise a
predetermined set of instructions. The predetermined set of instructions may,
for example, be
stored in an internal memory of the controller 300. Similarly, the controller
300 may store
predetermined reference intervals for any parameter that can be set, and the
controller 300 may be
configured to compare a received value for a parameter to such a predetermined
reference interval.
If the verification of the instruction would fail, the controller 300 may be
configured to reject the
instruction, i.e. not run the instruction.
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In an alternative to encrypting and decrypting the instruction, the
instruction may be signed
by the second external device 330 using a cryptographic hash, and the
controller 300 may be
configured to verify that the signature is correct before running the
instruction.
A corresponding method for transmitting an instruction will now be described
with
reference to Figs. 24b-c. The instruction may relate to a function of the
implantable device, such as
an instruction to run a function or method of the implantable device, or to
set a value of a parameter
of the implantable device. The method comprises: transmitting an instruction
for the implantable
device from the first external device 300 to a second external device 320, the
instruction relating to
a function of the implantable device 100, encrypting, at the second external
device 330 using a first
encryption key, the instruction into an encrypted instruction, and
transmitting the encrypted
instruction from the second external device 330 to the implantable device 100,
decrypting, at the
implantable device, the instructions using a second encryption key
corresponding to the first
encryption key. The steps performed by or at the implantable device may be
executed by the
controller 300.
The instruction may be any type of instruction for controlling a function of
the implantable
device. For example, the instruction may be an instruction to run a function
or method of the
implantable device 100 or controller 300, an instruction comprising a
plurality of sub-steps to be
run at the controller 300, or a value for a parameter at the controller 300.
The first external device
320 may, for example, receive the instruction from a user via a user interface
displayed at or
connected to the first external device 320. In another example, the first
external device 320 may
determine the instruction in response to data received from the implantable
device 100, such as
measurement data, or from another external device. Thus, in some examples, the
method may
further comprise receiving, at the first external device 320, an instruction
to be transmitted to the
implantable device 100. The method may further comprise displaying a user
interface for receiving
the instruction. In another example, the method comprises determining, at the
first external device
320, an instruction to be transmitted to the implantable device 100.
In some embodiments, the transmitting of the encrypted instruction from the
second
external device 330 to the implantable device 100 comprises transmitting the
encrypted instruction
from the second external device 330 to the first external device 320, and
transmitting the encrypted
instruction from the first external device 320 to the controller 300 of the
implantable device 100. In
other words, the first external device 320 may relay the encrypted instruction
from the second
external device 330 to the controller 300, preferably without decrypting the
instruction before
transmitting it.
The method may further comprise to, at the controller 300, running the
instruction or
performing the instruction. The running of the instruction may be performed by
an internal
computing unit or a processor 306 comprised in the controller 300, and may,
for example, cause the
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internal computing unit or processor 306 to instruct the implantable
constriciton device 302 to
perform an action.
The method may further comprise verifying, at the second external device 330,
that the
instructions are correct. The verifying may be performed as described above
with reference to the
corresponding system.
The method may further comprise verifying, at the controller 300, that the
instructions are
correct. The verifying may be performed as described above with reference to
the corresponding
system.
The method may further comprise authenticating the connection between the
first external
device 320 and the controller 300 over which the encrypted instruction is to
be transmitted. The
authentication may be performed as described herein.
As described above, a control program of the controller 300 may be updatable,
configurable or replaceable. A system and a method for updating or configuring
a control program
of the controller 300 is now described with reference to figs. 24b ¨ 24d. The
controller may
comprise an internal computing unit 306 configured to control a function of
the implantable device
100, the internal computing unit 306 comprises an internal memory 307
configured to store: i. a
first control program 310 for controlling the internal computing unit, and ii.
a second, configurable
or updatable, with predefined program steps, control program 312 for
controlling said function of
the implantable device 100, and iii. a set of predefined program steps for
updating the second
control program 312. The controller 300 is configured to communicate with an
external device 320.
The internal computing unit 306 is configured to receive an update to the
second control program
312 via the controller 300, and a verification function of, connected to, or
transmitted to the
controller 300. The verification function is configured to verify that the
received update to the
second control program 312 comprises program steps comprised in the set of
predefined program
steps. In this way, the updating or programming of the second control program
may be performed
using predefined program steps, which may decrease the risk that the new or
updated control
program is incorrect or comprises malicious software, such as a virus, spyware
or a malware.
The predefined program steps may comprise setting a variable related to a
pressure, a time,
a minimum or maximum temperature, a current, a voltage, an intensity, a
frequency, an amplitude
of electrical stimulation, a feedback mode (sensorics or other), a post-
operative mode or a normal
mode, a catheter mode, a fibrotic tissue mode (for example semi-open), an time
open after
urination, a time open after urination before bed-time, a blood pressure
reducing mode.
The verification function may be configured to reject the update in response
to the update
comprising program steps not comprised in the set of predefined program steps
and/or be
configured to allow the update in response to the update only comprising
program steps comprised
in the set of predefined program steps.
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The internal computing unit 306 may be configured to install the update in
response to a
positive verification, for example by a user using an external device, by a
button or similarly
pressed by a user, or by another external signal.
The authentication or verification of communications between the implant and
an external
device has been described above.
When updating a control program of the controller 300, it may be beneficial to
transmit a
confirmation to a user or to an external device or system. Such a method is
now described with
reference to figs. 24b ¨ 24c.
The method for updating a control program of a controller 300 comprised in the
implantable device 100 according to any of the embodiments herein. The
controller 300 is adapted
for communication with a first external device 320 and a second external
device 330, which may
comprise receiving, by the internal computing unit, an update or configuration
to the control
program from the first external device, wherein the update is received using a
first communication
channel; installing, by the internal computing unit 306, the update; and
transmitting, by the internal
computing unit, logging data relating to the receipt of the update or
configuration and/or logging
data relating to an installation of the update to the second external device
330 using the second
communication channel; wherein the first and the second communication channels
are different
communication channels. By using a first and a second communication channels,
in comparison to
only using one, the security of the updating may be improved as any attempts
to update the control
program will be logged via the second communication channel, and thus,
increasing the chances of
finding incorrect or malicious update attempts.
The update or configuration comprises a set of instructions for the control
program, and
may, for examples comprise a set of predefined program steps as described
above. The
configuration or update may comprise a value for a predetermined parameter.
In some examples, the method further comprises confirming, by a user or by an
external
control unit, that the update or configuration is correct based on the
received logging data.
The logging data may be related to the receipt of the update or configuration,
and the
controller 300 is configured to install the update or configuration in
response to receipt of a
confirmation that the logging data relates to a correct set of instructions.
In this way, the controller
300 may receive data, transmit a logging entry relating to the receipt, and
then install the data in
response to a positive verification that the data should be installed.
In another example, or in combination with the one described above, the
logging data is
related to the installation or the update or configuration. In this example
the logging data may be
for information purposes only and not affect the installation, or the method
may further comprise
activating the installation in response to the confirmation that the update or
configuration is correct.
If the update or configuration is transmitted to the controller 300 in one or
more steps, the
verification as described above may be performed for each of the steps.
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The method may further comprise, after transmitting the logging data to the
second
external device, verifying the update via a confirmation from the second
external device 330 via the
second communication channel.
With reference to Fig. 24b ¨ 24d there may further be provided an implantable
controller
300. The controller 300 is connected to a sensor 351 wherein the sensor 351 is
at least one
microphone sensor 351 configured to record acoustic signals. For instance, the
controller 300 may
be configured to register a sound related to at least one of a bodily function
of the patient and a
function of the implantable device 100. The controller 300 comprises a
computing unit 306
configured to derive at least one of a pulse of the patient from the
registered sound related to a
.. bodily function, such as information related to the patient urinating, from
the registered sound
related to a bodily function. In the alternative, the controller 300 could be
configured to derive
information related to a functional status of the implantable device 100 from
the registered sound,
such as RPM of the motor. To this end the computing unit 306 may be configured
to perform signal
processing on the registered sound (e.g. on a digital or analog signal
representing the registered
sound) so as to derive any of the above mentioned information related to a
bodily function of the
patient or a function of the implantable device 100. The signal processing may
comprise filtering
the registered sound signals of the microphone sensor 351.
The implantable controller is placed in an implantable housing for sealing
against fluid, and
the microphone sensor 351 is placed inside of the housing. Accordingly, the
controller and the
microphone sensor 351 do not come into contact with bodily fluids when
implanted which ensures
proper operation of the controller and the microphone sensor 351.
In some implementations, the computing unit 306 is configured to derive
information
related to the functional status of an active unit 302 of the implantable
device 100, from the
registered sound related to a function of the implantable device 100.
Accordingly, the computing
unit 306 may be configured to derive information related to the functional
status of at least one of:
a motor, a pump and a transmission of the active unit 302 of the implantable
device 100, from the
registered sound related to a function of the implantable device 100.
The controller may comprise a transceiver 303, 308 configured to transmit a
parameter
derived from the sound registered by the at least one microphone sensor 351
using the transceiver
303, 308. For example, the transceiver 303, 308 is a transceiver configured to
transmit the
parameter conductively 303 to an external device 320 or wirelessly 308 to an
external device 320.
A method of authenticating the implantable device 100, the external device 320
or a
communication signal or data stream between the external device 320 and the
implantable device
100 is also described with reference to figs. 24b ¨ 24d. The method comprises
the steps of
.. registering a sound related to at least one of a bodily function and a
function of the implantable
device 100, using the at least one microphone sensor 351, connected to the
controller 300. The
method could in a first authentication embodiment comprise transmitting a
signal derived from the
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registered sound, using the transceiver 303, 308, receiving the signal in the
external device 320,
using the receiver 323, 328 and comparing, in the external device 320, a
parameter derived from
the received signal with a reference parameter, using the computing unit 306.
The method could in
a second authentication embodiment comprise receiving a signal in the
controller 300, from the
external device 320, using the transceiver 323, 328 and deriving a reference
parameter from the
received signal, using the computing unit 306 of the controller 300, and
comparing, in the
controller 300, a parameter derived from the received signal with the derived
reference parameter,
using the computing unit 306 of the controller 300. The methods further
comprise the steps of the
implantable controller 300 authenticating the external device 320, or the
external device 320
authenticating the implantable controller 300, on the basis of the comparison.
The registered sound
could for example be related to the pulse of the patient or to the patient
urinating.
Embodiments relating to an implantable device 100 having a controller 300
having a
processor 306 with a sleep mode and an active mode will now be described with
reference to Fig.
24e. The implant, the internal communication unit and the external device(s)
may have the features
described above with reference to figs. 24b ¨ 24d.
In an embodiment in which the controller 300 comprises a processor 306 having
a sleep
mode and an active mode, the controller 300 comprises or is connected to a
sensor 140 and a
processing unit 306 having a sleep mode and an active mode. The sensor 140 is
configured to
periodically measure a physical parameter of the patient, and the controller
300 is further
configured to, in response to a sensor measurement preceding a predetermined
value, setting the
processing unit 306 in an active mode. That is, the controller 300 may "wake
up" or be set in an
active mode in response to a measurement from, for example, the body. A
physical parameter of
the patient could for example be a pressure in a blood vessel, such as the
renal artery, or a vascular
(flow) resistance in a blood vessel, local or systemic temperature,
saturation/oxygenation, systemic
blood pressure or a parameter related to an ischemia marker such as lactate.
By sleeping mode it is meant a mode with less battery consumption and/or
processing
power used in the processing unit 306, and by "active mode" it may be meant
that the processing
unit 306 is not restricted in its processing.
The sensor 140 may, for example, be a pressure sensor. The pressure sensor may
be
adapted to measure a pressure in an organ of a patient, such as the renal
artery, or a vasodilation or
a vasoconstriction of said artery. The pressure sensor may further be
configured to measure a
pressure in a reservoir of the implant or a constriction device of the active
unit 302. The sensor 140
may be an analog sensor or a digital sensor, i.e. a sensor 140 implemented in
part in software. In
some examples, the sensor is adapted to measure one or more of a battery or
energy storage status
of the implantable device 100 and a temperature of the implantable device 100.
In this way, the
sensor 140 may periodically sense a pressure of the implantable device 100 or
of the patient, and
set the processing unit 306 in an active mode if the measured pressure is
above a predetermined
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value. Thus, less power, i.e. less of for example a battery or energy storage
comprised in the
implant, may be used, thereby prolonging the lifetime of the implantable
device 100 or increasing
the time between charging occasions of the implantable device 100.
In some examples, the processor 306, when in set in the active mode, may cause
a
sensation generator 381 connected to the implant, comprised in the implantable
device 100 or
comprised in an external device 320, 330, to generate a sensation detectable
by a sense of the
patient. For example, the processor may cause the sensation generator to
generate a sensation in
response to a measure battery status, for example that the battery is above or
below a
predetermined level, that a measured pressure is above or below a
predetermined level, or that
another measured parameter has an abnormal value, i.e. less than or exceeding
a predetermined
interval or level. The sensation generator has been described in further
detail earlier in this
description.
The processing unit 306 may be configured to perform a corrective action in
response to a
measurement being below or above a predetermined level. Such a corrective
action may, for
example, be increasing or decreasing a pressure, increasing or decreasing
electrical stimulation,
increasing or decreasing power, adjusting a signal damping function, and the
like.
The controller 300 may comprise a signal transmitter 320 connected to the
processing unit,
and wherein the processing unit is configured to transmit data relating to the
measurement via the
transceiver 308 of the controller 300 or an additional internal signal
transmitter 392. The
transmitted data may be received by an external device 320.
The external device may have an external communication unit 390. The external
device
320 may comprise a signal provider 380 for providing a wake signal to the
controller 300. In some
examples, the signal provider comprises a coil or magnet 371 for providing a
magnetic wake
signal.
The controller 300 may implement a corresponding method for controlling an
implantable
device 100 when implanted in a patient. The method comprises measuring, with a
sensor of the
controller 300 connected to or comprised in the controller 300, a
physiological parameter of the
patient or a parameter of the implantable device 100, and, in response to a
sensor measurement
having an abnormal value, setting, by the controller 300, a processor 306 of
the controller 300 from
a sleep mode to an active mode. The measuring may be carried out periodically.
By "abnormal
value" it may be meant a measured value exceeding or being less than a
predetermined value, or a
measured value being outside a predetermined interval. The method may further
comprise
generating, with a sensation generator 381 as described above, a sensation
detectable by the patient.
In some examples, the generating comprises requesting, by the processor, the
sensation generator
381 to generate the sensation.
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The method may further comprise to perform a medical intervention in response
to a sensor
measurement having an abnormal value, preferably after the processing unit has
been set in the
active mode.
A system comprising an implantable device 100 having a controller 300 having a
sleep
mode and an active mode will now be described with reference to Fig. 24e. In
one embodiment, the
controller 300 comprises a sensor 140 adapted to detect a magnetic field and a
processing unit 306
having a sleep mode and an active mode, now described with reference to figs.
24b ¨ 24d. The
external control unit 320 comprises a signal provider 380 adapted to provide a
magnetic field
detectable by the internal sensor 140. The controller 300 is further
configured to, in response to a
detected magnetic field exceeding a predetermined value, setting the
processing unit 306 in an
active mode. In this way, the external device 320 may cause a sleeping
controller 300 or processor
306 to "wake up".
The sensor 140 may, for example, be a hall effect sensor, a fluxgate sensor,
an ultra-
sensitive magnetic field sensor, a magneto-resistive sensor, an AMR or GMR
sensor, or the sensor
may comprise a third coil having an iron core.
The magnetic field provider 380 may have an off state, wherein it does not
provide any
magnetic field, and an on state, wherein it provides a magnetic field. For
example, the magnetic
field provider 380 may comprise a magnet 371, a coil 371, a coil having a core
371, or a permanent
magnet 371. In some embodiments, the magnetic field provider 380 may comprise
a shielding
means for preventing a magnet 371 or permanent magnet 371 from providing a
magnetic field in
the off state. In order to provide a substantially even magnetic field, the
magnetic field provider
may comprise a first and a second coil arranged perpendicular to each other.
After the processing unit 306 has been set in an active mode, i.e. when the
processing unit
306 has been woken, the implant may determine a frequency for further
communication between
the controller 300 and the external device 320. The controller 300 may thus
comprise a frequency
detector 391 for detecting a frequency for communication between the
controller 300 and the
second communication unit 390. The frequency detector 391 is, for example, an
antenna. The
external device 320 may comprise a frequency indicator 372, for transmitting a
signal indicative of
a frequency. The frequency indicator 372, may, for example, be a magnetic
field provider capable
.. of transmitting a magnetic field with a specific frequency. In some
examples the frequency
indicator is comprised in or the same as the magnetic field provider 371. In
this way, the frequency
signal is detected using means separate from the sensor, and can, for example,
be detected using a
pin on a chip.
Alternatively, the controller 300 and the external device 320 may communicate
using a
.. predetermined frequency or a frequency detected by means defined by a
predetermined method
according to a predetermined protocol to be used for the communication between
the controller 300
and the external device 320.
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In some embodiments, the sensor 140 may be used for the communication. The
communication may in these embodiments be performed with such that a frequency
of the
magnetic field generated by the coil is 9-315 kHz, or the magnetic field
generated by the coil is less
than or equal to 125kHz, preferably less than 58kHz. The frequency may be less
than 50Hz,
preferably less than 20Hz, more preferably less than 10Hz, in order to be
transmittable through a
titan box.
In some embodiments, the controller 300 comprises a receiver unit 392, and the
internal
control unit and the external control unit are configured to transmit and/or
receive data via the
receiver unit 392 via magnetic induction. The receiver unit 392 may comprise a
high-sensitivity
magnetic field detector, or the receiver unit may comprise a fourth coil for
receiving the magnetic
induction.
The system may implement a method for controlling a medical implant implanted
in a
patient. The method comprises monitoring for signals by a sensor 140 comprised
in the controller
300 communicatively coupled to the active unit 302, providing, from a signal
provider 380
comprised in an external device 320, a wake signal, the external device 320
being adapted to be
arranged outside of the patient's body, and setting, by the controller 300 and
in response to a
detected wake signal WS, a mode of a processing unit 306 comprised in the
internal control unit
from a sleep mode to an active mode.
The method may also comprise detecting, using a frequency detector 391, a
frequency for
data communication between the controller 300 and a second communication unit
390 being
associated with the external device 320. The frequency detector 391 is
communicatively coupled to
the controller 300 or the external device 320. The detection may be performed
using a detection
sequence for detecting the frequency. This detection sequence may, for
example, be a detection
sequence defined in the protocol to be used for communication between the
controller 300 and the
second communication unit 390. Potential protocols that may be used for
communication between
the controller 300 and the external device 320 has been described earlier in
this description. Thus,
the method may comprise determining, using the frequency detector 391, the
frequency for data
communication, and initiating data communication between the controller 300
and the second
communication unit 390. The data communication can, for example, comprise one
or more control
instructions for controlling the implantable device 100 transmitted from the
external device 320, or,
for example, comprise data related to the operation of the implantable device
100 and be
transmitted from the controller 300.
In some examples, the medical implant may comprise or be connected to a power
supply
for powering the implantable device 100. This will now be described with
reference to fig. 24f. The
medical implant, the internal control unit, and the external device(s) may
comprise all elements
described above with reference to figs. 24a ¨ 24d and fig. 24e. In some
examples, the power supply
may comprise an energy receiver 241 and an energy source 242 as discussed
above in connection
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with figure 24a. The power supply may hence comprise an implantable or
external energy storage
unit 242, 40 for providing energy to the medical implant (for instance via the
energy receiver 241),
an energy provider 397 connected to the implantable energy storage unit 40 and
connected to an
energy consuming part of the implantable device 100, the energy provider 397
being configured to
.. store energy to provide a burst of energy to the energy consuming part,
wherein the energy
provider 397 is configured to be charged by the implantable energy storage
unit 40 and to provide
the energy consuming part with electrical power during startup of the energy
consuming part. The
energy consuming part may for example include the controller or control unit,
or the electrode
arrangement of a stimulation device or a signal damping device.
Alternatively, the implantable device 100 may comprise a first implantable
energy storage
unit 40 for providing energy to an energy consuming part of the implantable
device 100, a second
implantable energy storage unit 397 connected to the implantable energy
storage unit 40 and
connected to the energy consuming part, wherein the second implantable energy
storage unit 397 is
configured to be charged by the implantable energy storage unit 40 and to
provide the energy
consuming part with electrical power during startup of the energy consuming
part. The second
implantable energy storage unit 397 has a higher energy density than the first
implantable energy
storage unit 40. By having a "higher energy density" it may be meant that the
second implantable
energy storage unit 397 has a higher maximum energy output per time unit than
the first
implantable energy storage unit 40. The second energy storage 397 may be an
energy provider as
discussed below.
The energy consuming part may be any part of the implantable device 100, such
as a
motor for powering the hydraulic pump, a valve, a processing or computing
unit, a communication
unit, a device for providing electrical stimulation to a tissue portion of the
body of the patient, a
CPU for encrypting information, a transmitting and/or receiving unit for
communication with an
external unit (not shown as part of the energy consuming part in the drawings,
that is, the
communication unit may be connected to the energy storage unit 40 and to the
energy provider
397), a measurement unit or a sensor, a data collection unit, a solenoid, a
piezo-electrical element, a
memory metal unit, a vibrator, a part configured to operate a valve comprised
in the medical
implant, or a feedback unit.
In this way, an energy consuming part requiring a quick start or an energy
consuming part
which requires a high level or burst of energy for a start may be provided
with sufficient energy.
This may be beneficial as instead of having an idle component using energy,
the component may
be completely turned off and quickly turned on when needed. Further, this may
allow the use of
energy consuming parts needing a burst of energy for a startup while having a
lower energy
consumption when already in use. In this way, a battery or an energy storage
unit having a slower
discharging (or where a slower discharging is beneficial for the lifetime or
health of the battery)
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may be used for the implant, as the extra energy needed for the startup is
provided by the energy
provider.
Energy losses may occur in a battery or energy storage unit of an implant if
the battery or
energy storage unit is discharged too fast. These energy losses may for
example be in the form of
heat, which may damage the battery or energy storage unit. By the apparatus
described in these
examples, energy may be provided from the battery or energy storage unit in a
way that does not
damage the battery or energy storage unit, which may improve the lifetime of
the battery or energy
storage unit and thereby the lifetime of the medical implant.
In some examples, the discharging from the implantable energy storage unit 40
during
startup of the energy consuming part is slower than the energy needed for
startup of the energy
consuming part, i.e. the implantable energy storage unit 40 is configured to
have a slower
discharging than the energy needed for startup of the energy consuming part.
That is, there is a
difference between the energy needed by the energy consuming part and the
energy the implantable
energy storage unit 40 is capable of providing without damaging the
implantable energy storage
unit 40. In other words, a maximum energy consumption of the energy consuming
part may be
higher than the maximum energy capable of being delivered by the implantable
energy storage unit
40 without causing damage to the implantable energy storage unit, and the
energy provider 397
may be adapted to deliver an energy burst corresponding to difference between
the required energy
consumption and the maximum energy capable of being delivered by the
implantable energy
storage unit 40. The implantable energy storage unit 40 may be configured to
store a substantially
larger amount of energy than the energy burst provider 397 but may be slower
to charge.
The implantable energy storage unit 40 may be any type of energy storage unit
suitable for
an implant, such as a re-chargeable battery or a solid-state battery, such as
a thionyl-chloride
battery. The implantable energy storage unit 40 may be connected to the energy
consuming part
and configured to power the energy consuming part after it has been started
using the energy
provider 397.
The energy provider 397 may be any type of part configured to provide a burst
of energy
for the energy consuming part. In some examples, the energy provider 397 is a
capacitor, such as a
start capacitor, a run capacitor, a dual run capacitor or a supercapacitor.
The energy provider 397
may be connected to the implantable energy storage unit 40 and be adapted to
be charged using the
implantable energy storage unit 40. In some examples, the energy provider may
be a second energy
provider 397 configured to be charged by the implantable energy storage unit
40 and to provide the
energy consuming part with electrical energy. The implantable device 100 may
further comprising
a temperature sensor for sensing a temperature of the capacitor and the
temperature sensor may be
integrated or connected to the controller 300 such that the sensed temperature
can be used as input
for controlling the implantable device 100 or as feedback to be sent to an
external device 320.
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A corresponding method for powering a medical implant may also be
contemplated. The
method comprises the steps of initiating an energy consuming part 302 of the
implant, the energy
consuming part being connected to an implantable energy storage unit 40,
providing an initial burst
of energy to the energy consuming part using an energy provider 397 connected
to the implantable
energy storage unit 40 and to the energy consuming part 302, the energy
provider 397 being
adapted to provide a burst of energy to the energy consuming part, and
subsequently powering the
energy consuming part 302 using the implantable energy storage unit 40.
In some examples, a maximum energy consumption of the energy consuming part is
higher
than the maximum energy capable of being delivered by the implantable energy
storage unit 40
without causing damage to the implantable energy storage unit 40, and the
energy provider 397 is
adapted to deliver an energy burst corresponding to difference between the
required energy
consumption and the maximum energy capable of being delivered by the
implantable energy
storage unit 40. The energy consuming part may for instance be a control unit
controlling the
electrical stimulation or damping, a sensor, or a transceiver.
The method may further comprise the step of charging the energy provider 397
using the
implantable energy storage unit 40.
Initiating an energy consuming part 302 may comprise transitioning a control
unit of the
medical implant from a sleep mode to an operational or active mode.
The implantable energy storage unit 40 may be adapted to be wirelessly charged
and the
implantable energy storage unit may be connected to an internal charger 395
for receiving wireless
energy from an external device 320 via an external charger 396, and the method
may comprise
wirelessly charging the implantable energy storage unit 40. In some examples,
the method
comprises controlling a receipt of electrical power from an external energy
storage unit at the
internal charger 395. The internal energy storage unit 40 may be charged via
the receipt of a
transmission of electrical power from an external energy storage unit 396 by
the internal charger
395.
Fig. 25a shows one embodiment of a system for charging, programming and
communicating with the controller 300 of the implanted system 100. Fig. 25a
further describes the
communication and interaction between different external devices which may be
devices held and
operated by the patient, by the health care provider (HCP) or by the Dedicated
Data Infrastructure
(DDI), which is an infrastructure supplier for example by the manufacturer of
the implanted
medical device 100 or the external devices 320', 320", 320'". The system of
the embodiment of
fig. 25a comprises three external devices 320', 320", 320" capable of
communicating with the
controller 300.
The basic idea is to ensure the security of the communication with, and the
operation of,
the system 100 by having three external devices 320', 320", 320" with
different levels of
authority. The lowest level of authority is given to the patient operated
remote control 320". The
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remote control, also referred to as external device 320" is authorized to
operate functions of the
implanted system 100 via the implanted controller 300, on the basis of patient
input. The remote
control 320" is further authorized to fetch some necessary data from the
controller 300. The remote
control 320" is only capable of operating the controller 300 by communicating
with the software
currently running on the controller 300, with the currently settings of the
software. The next level
of authority is given to the Patient External Interrogation Device (P-EID)
320", which is a
charging and communication unit which is held by the patient but may be
partially remotely
operated by the Health Care Provider (HCP) (Usually a medical doctor with the
clinic providing
the treatment with help of the implanted system 1). The P-EID 320" is
authorized to make setting
changes by selecting pre-programmed steps of the software or hardware running
on the controller
300 of the implanted system 100. The P-EID is remotely operated by the HCP,
and receives input
from the HCP, via the DDI.
The highest level of authority is given to the HCP-EID 320' and its
controller, referred to
as the HCP Dedicated Display Device (DDD). The HCP-EID 320' is a charging and
communication unit which may be located physically at the clinic of the HCP.
The HCP-EID 320'
may be authorized to freely alter or replace the software running on the
controller 300, when the
patient is physically in the clinic of the HCP. The HCP-EID 320' is controlled
by the HCP DDD,
which either may act on a "webview" portal from the HCP-EID or be a device
closed down to any
activities (which may include the absence of an internet connection) other
than controlling and
communicating with the HCP-EID. The webview portal does not necessarily mean
internet based
or HTML-protocol and the webview portal may be communicated over other
communicating
protocols such as Bluetooth or any other type of standard or proprietary
protocol. The HCP DDD
may also communicate with the HCP-EID over a local network or via Bluetooth or
other standard
or proprietary protocols.
Starting from the lowest level of authority, the patient remote control
external device 320"
beneficially may comprise a wireless transceiver 328 for communicating with
the implanted system
100. The remote control 320" is capable of controlling the operation of the
implanted system 100
via the controller 300, by controlling pre-set functions of the implantable
system 1, e.g. for
operating an active portion of the implanted system 100 for performing the
intended function of the
implanted system 1. The remote control 320" is able to communicate with the
implanted system
100 using any standard or proprietary protocol designed for the purpose. In
the embodiment shown
in fig. 25a, the wireless transceiver 328 comprises a Bluetooth (BT)
transceiver, and the remote
control 320" is configured to communicate with implanted system 100 using BT.
In an alternative
configurations, the remote control 320" communicates with the implanted system
100 using a
combination of Ultra-Wide Band (UWB) wireless communication and BT. The use of
UWB
technology enables positioning of the remote control 320" which can be used by
the implanted
system 100 as a way to establish that the remote control 320" is at a position
in which the
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implanted system 100 and/or the patient can acknowledge as being correct, e.g.
in the direct
proximity to the medical device 100 and/or the patient, such as within reach
of the patient and/or
within 1 or 2 meters of the implanted system 1.
UWB communication may be performed by the generation of radio energy at
specific time
intervals and occupying a large bandwidth, thus enabling pulse-position or
time modulation. The
information can also be modulated on UWB signals (pulses) by encoding the
polarity of the pulses,
their amplitude and/or by using orthogonal pulses. A UWB radio system can be
used to determine
the "time of flight" of the transmission at various frequencies. This helps
overcome multipath
propagation, since some of the frequencies have a line-of-sight trajectory,
while other indirect paths
have longer delay. With a cooperative symmetric two-way metering technique,
distances can be
measured at high resolution and accuracy. UWB is useful for real-time location
systems, and its
precision capabilities and low power make it well-suited for radio-frequency-
sensitive
environments, such as health care environments.
In embodiments in which a combination of BT and UWB technology is used, the
UWB
technology may be used for location-based authentication of the remote control
320", whereas the
communication and/or data transfer could take place using BT or any other way
of communicating
different from the UWB. The UWB signal could in some embodiments also be used
as a wake-up
signal for the controller 300, or for the BT transceiver, such that the BT
transceiver in the
implanted system 100 can be turned off when not in use, which eliminates the
risk that the BT is
intercepted, or that the controller 300 of the implanted system 100 is hacked
by means of BT
communication. In embodiments in which a BT (or alternatives) / UWB
combination is used, the
UWB connection may be used also for the transmission of data. In the
alternative, the UWB
connection could be used for the transmission of some portions of the data,
such as sensitive
portions of the data, or for the transmission of keys for the unlocking of
encrypted communication
sent over BT.
The remote control 320" comprises a computing unit 326 configured to run a
software
application for communicating with the implanted system 1. The computing unit
326 can receive
input directly from control buttons 335 arranged on the remote control 320" or
may receive input
from a control interface 334i displayed on a patient display device 334
operated by the patient. In
the embodiments in which the remote control 320" receives input from a control
interface 334i
displayed on the patient display device 334 operated by the patient, the
remote control 320" may
transmit the control interface 334i in the form of a web-view portal, i.e. a
remote interface running
in a sandbox environment on the patient's display device 334. A sandbox
environment is
understood as running on the display device 334 but only displaying what is
presented from the
remote control, and only using a tightly controlled set of commands and
resources, such as storage
and memory space as well as network access. The ability to inspect the host
system and read or
write from other input devices connected to the display device 334 may
therefore be extremely
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limited. Any action or command generated by the patient display device may be
similar to
controlling a webpage. All acting software may be located on the remote
control that only displays
its control interface onto the patient display unit.
The computing unit 326 may further be configured to encrypt the control
interface before
transmission to the patient display device 334, and encrypt the control
commands before
transmission to the implanted system 1. The computing unit 326 is further
configured to transform
the received user input into control commands for wireless transmission to the
implantable system
1.
The patient's display device 334 could for example be a mobile phone, a tablet
or a smart
watch. In the embodiment shown in fig. 25a, the patient's display device 334
communicates with
the remote control 320" by means of BT. The control interface 334i in the form
of a web-view
portal is transmitted from the remote control 320" to the patient's display
device 334 over BT.
Control commands in the form of inputs from the patient to the control
interface 334i may be
transmitted from the patient's display device 334 to the remote control 320",
providing input to the
remote control 320" equivalent to the input that may be provided using the
control buttons 335.
The control commands created in the patient's display device 334 may be
encrypted in the patient's
display device 334 and transmitted to the remote control 320' using BT or any
other
communication protocol.
The remote control may normally not be connected to the DDI or the Internet,
thereby
increasing security. In addition, the remote control 320" may in one
embodiment have its own
private key. In a specific embodiment, the remote control 320" may be
activated by the patient's
private key for a certain time period. This may activate the function of the
patient's display device
and the remote wed-view display portal supplied by the remote control to the
patient's display
device.
The patient's private key may be supplied in a patient private key device
compromising a
smartcard that may be inserted or provided close to the remote control 320" to
activate a
permission to communicate with the implant 100 for a certain time period.
The patient's display device 334 may (in the case of the display device 334
being a mobile
phone or tablet) comprise auxiliary radio transmitters for providing an
auxiliary radio connection,
such as a Wi-Fi or mobile connectivity (e.g. according to the 3G,4G or 5G
standards). The
auxiliary radio connection(s) may have to be disconnected to enable
communication with the
remote control 320". Disconnecting the auxiliary radio connections reduces the
risk that the
integrity of the control interface 334i displayed on the patient's display
device 334 is compromised,
or that the control interface 334i displayed on the patient's display device
334 is remotely
controlled by an unauthorized device or entity.
In alternative embodiments, control commands are generated and encrypted by
the
patient's display device and transmitted to the DDI 330. The DDI 330 could
either alter the created
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control commands to commands readable by the remote control 320" before
further encrypting the
control commands for transmission to the remote control 320", or could simply
add an extra layer
of encryption before transmitting the control commands to the remote control
320", or could
simply act as a router for relaying the control commands from the patients'
display device 334 to
the remote control 320". It is also conceivable that the DDI 330 adds a layer
of end-to-end
encryption directed at the implanted system 1, such that only the implanted
system 100 can decrypt
the control commands to perform the commands intended by the patient. In the
embodiments
above, when the patient remote display device 334 is communicating with the
DDI, the patient's
display device 334 may be configured to only display and interact with a web-
view portal provided
by a section of the DDI. It is conceivable that the web-view portal is a view
of a back-end provided
on the DDI 330, and that in such embodiments the patient interacting with the
control interface on
the patient's display device 334 is equivalent to the patient interacting with
an area of the DDI 330.
The patient's display device 334 could have a first and second application
related to the
implanted system 1. The first application is the control application
displaying the control interface
334i for control of the implanted system 1, whereas the second application is
a general application
for providing the patient with general information of the status of the
implanted system 100 or
information from the DDI 330 or HCP, or for providing an interface for the
patient to provide
general input to the DDI 330 or HCP related to the general wellbeing of the
patient, the lifestyle of
the patient or related to general input from the patient concerning the
function of the implanted
system 1. The second application, which do not provide input to the remote
control 320" and/or the
implanted system 100 thus handles data which is less sensitive. As such, the
general application
could be configured to function also when all auxiliary radio connections are
activated, whereas
switching to the control application which handles the more sensitive control
commands and
communication with the implanted system 100 could require that the auxiliary
radio connections
are temporarily de-activated. It is also conceivable that the control
application is a sub-application
running within the general application, in which case the activation of the
control application as a
sub-application in the general application could require the temporary de-
activation of auxiliary
radio connections. In the embodiment shown in fig. 25a, access to the control
application requires
the use of the optical and/or NFC means of the hardware key 333' in
combination with biometric
input to the patient's display device, whereas accessing the general
application only requires
biometric input to the patient's display device and/or a pin code. In an
example, a two-factor
authentication solution, such as a digital key in combination with a pin code
could be used for
accessing the general application and/or the control application.
In general, a hardware key may be needed to activate the patient display
device 334 for
certain time period to control the web-view portal of the remote control 320",
displaying the
control interface 334i for control of the implanted system 1.
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In the embodiments in which the patients display device 334 is configured to
only display
and interact with a web-view provided by another unit in the system, it is
conceivable that the web-
view portal is a view of a back-end provided on the DDI 330, and in such
embodiments, the patient
interacting with the control interface on the patient's display device is
equivalent to the patient
interacting with an area of the DDI 330.
Moving now to the P-EID 320". The P-EID 320" ' is an external device used by
the
patient, patient external device, configured to communicate with, and charge,
the implanted system
1. The P-EID 320" can be remotely controlled by the HCP to read information
from the implanted
system 1. The P-EID 320" is adapted to control the operation of the implanted
system 1, control
.. the charging of the implantable system 1, and adjust the settings on the
controller 300 of the
implanted system 100 by changing pre-defined pre-programmed steps and/or by
the selection of
pre-defined parameters within a defined range.
Similar to the remote control 320", the P-EID 320" may be configured to
communicate
with the implanted system 100 using BT or UWB communication or any other
proprietary or
standard communication method. Since the device may be used for charging the
implant, the
charging signal and communication could be combined. Similar to the remote
control 320", it is
also possible to use a combination of UWB wireless communication and BT for
enabling
positioning of the P-EID 320" as a way to establish that the P-EID 320" is at
a position which the
implanted system 100 and/or patient and/or HCP can acknowledge as being
correct, e.g. in the
.. direct proximity to the correct patient and/or the correct system 1. Just
as for the remote control
320", in embodiments in which a combination of BT and UWB technology is used,
the UWB
technology may be used for location-based authentication of the P-EID 320",
whereas the
communication and/or data transfer could take place using BT. The P-EID 320"
comprises a
wireless transmitter/transceiver 328 for communication and also comprises a
wireless transmitter
325 configured for transferring energy wirelessly, which may be in the form of
a magnetic field or
any other signal such as electromagnetic, radio, light, sound or any other
type of signal to transfer
energy wirelessly to a wireless receiver 395 of the implanted system 1. The
wireless receiver 395
of the implanted system 100 is configured to receive the energy in the form of
the magnetic field
and transform the energy into electric energy for storage in an implanted
energy storage unit 40,
.. and/or for consumption in an energy consuming part of the implanted system
100 (such as the
operation device, controller 300 etc.). The magnetic field generated in the P-
EID 320" and
received in the implanted system 100 is denoted charging signal. In addition
to enabling the
wireless transfer of energy from the P-EID 320" to the implanted system 1, the
charging signal
may also function as a means of communication. E.g., variations in the
frequency of the
transmission, and/or the amplitude of the signal may be uses as signaling
means for enabling
communication in one direction, from the P-EID 320" to the implanted system 1,
or in both
directions between the P-EID 320" and the implanted system 1. The charging
signal in the
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embodiment shown in fig. 25a is a signal in the range 10 - 65kHz or 115 ¨ 140
kHz and the
communication follow a proprietary communication signaling protocol, i.e., it
is not based on an
open standard. In alternative embodiments, BT could be combined with
communication using the
charging signal, or communication using the charging signal could be combined
with an UWB
signal. The energy signal could also be used as a carrying signal for the
communication signal.
Just as for the remote control 320", the UWB signal could in some embodiments
also be
used as a wake-up signal for the controller 300, or for the BT transceiver,
such that the BT
transceiver in the implanted system 100 can be turned off when not in use,
which eliminates the
risk that the BT is intercepted, or that the controller 300 of the implanted
system 100 is hacked by
means of BT communication. In some examples, the charging signal could be used
as a wakeup
signal for the BT, as the charging signal does not necessarily travel very
far. Also, as a means of
location-based authentication, the effect of the charging signal or the RSSI
could be assessed by the
controller 300 in the implanted system 100 to establish that the transmitter
is within a defined
range. In the BT/UWB combination, the UWB may be used also for transmission of
data. In some
embodiments, the UWB and/or the charging signal could be used for the
transmission of some
portions of the data, such as sensitive portions of the data, or for the
transmission keys for
unlocking encrypted communication sent by BT. Wake-up could be performed with
any other
signal.
UWB could also be used for waking up the charging signal transmission, to
start the
wireless transfer of energy or for initiating communication using the charging
signal. As the signal
for transferring energy has a very high effect in relation to normal radio
communication signals, the
signal for transferring energy cannot be active all the time, as this signal
may be hazardous e.g., by
generating heat.
The P-EID 320" may communicate with the HCP over the Internet by means of a
secure
communication, such as over a VPN. The communication between the HCP and the P-
EID 320"
is preferably encrypted. Preferably, the communication is sent via the DDI,
which may only be
relaying the information. The communication from the HCP to the implanted
system 100 may be
performed using an end-to-end encryption, in which case the communication
cannot be decrypted
by the P-EID 320". In such embodiments, the P-EID 320" acts as a router, only
passing on
encrypted communication from the HCP to the controller 300 of the implanted
system 100 (without
full decryption). This solution further increases security as the keys for
decrypting the information
rests only with the HCP and with the implanted system 1, which reduces the
risk that an
unencrypted signal is intercepted by an unauthorized device. The P-EID 320"
may add own
encryption or information, specifically for security reasons. The P-EID 320"
may hold its own
private key and may be allowed to communicate with the implant 100 based on
confirmation from
the patient's private key, which may be provided as a smartcard to be inserted
in a slot of the P-EID
320" or hold in close proximity thereto to be read by the P-EID 320". These
two keys will add a
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high level of security to the performed communication between the implanted
system 100 and the
P-EID 320" since the patient's hardware key in this example on the smartcard
may activate and
thereby allow the communication and action taken in relation to the system 1.
The P-EID 320"
may as previously described change the treatment setting of the system 100 by
selecting pre-
.. programmed steps of the treatment possibilities. Such pre-programmed
treatment options may
include for example to change:
at least one of the level of constriction, pressure or position of a
hydraulic, mechanic,
and/or electric stimulation device,
the volume of an operable volume filling device employed to adjust a cuff
arranged at the
renal artery,
parameters of an implant communicating with a database outside the body, such
as key
handshake, new key pairing, signal amplitude etc.,
parameters of an implant able to be programmed from outside the body,
parameters of an implant able to be programmed from outside the body with a
wireless
signal,
When the implanted medical device 100 is to be controlled and/or updated
remotely by the
HCP, via the P-EID 320", a HCP Dedicated Device (DD) 332 displays an interface
in which
predefined program steps or setting values are presented to the HCP. The HCP
provides input to
the HCP DD 332 by selecting program steps, altering settings and/or values or
by altering the order
in which pre-defined program steps is to be executed. The
instructions/parameters inputted into the
HCP DD 332 for remote operation is in the embodiment shown in fig. 25a routed
to the P-EID
320" via the DDI 330, which may or may not be able to decrypt/read the
instructions. The DDI
330 may store the instructions for a time period to later transfer the
instructions in a package of
created instructions to the P-EID 320". It is also conceivable that an
additional layer of encryption
is provided to the package by the DDI 330. The additional layer of encryption
may be a layer of
encryption to be decrypted by the P-EID 330, or a layer of encryption which
may only be decrypted
by the controller 300 of the implanted system 1, which reduces the risk that
unencrypted
instructions or packages are intercepted by unauthorized devices. The
instructions/parameters are
then provided to the P-EID 320", which then loads the instructions/parameters
into the during the
next charging/energy transfer to the implanted system 100 using any of the
signal transferring
means (wireless or conductive) disclosed herein.
The Health Care Provider EID (HCP EID) 320' have the same features as the P-
EID 320"
and can communicate with the implanted system 100 in the same alternative ways
(and
combinations of alternative ways) as the P-EID 320". However, in addition, the
HCP EID 320'
also enables the HCP to freely reprogram the controller 300 of the implanted
system 1, including
replacing the entire program code running in the controller 300. The idea is
that the HCP EID 320'
always remain with the HCP and as such, all updates to the program code or
retrieval of data from
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the implanted system 100 using the HCP EID 320' is performed with the HCP and
patient present
(i.e. not remote). The physical presence of the HCP is an additional layer of
security for these
updates which may be critical to the function of the implanted system 1.
In the embodiment shown in fig. 25a, the HCP communicates with the HCP EID
320'
using a HCP Dedicated Display Device 332 (HCP DDD), which is a HCP display
device
comprising a control interface for controlling and communicating with the HCP
EID 320'. As the
HCP EID 320' always stays physically at the HCP's clinic, communication
between the HCP EID
320' and HCP DDD 332 does not have to be sent over the Internet. Instead, the
HCP DDD 332 and
the HCP EID 320' can communicate using one or more of BT, a proprietary
wireless
communication channel, or a wired connection. The alteration to the
programming is then sent to
the implanted system 100 directly via the HCP EID 320'. Inputting into the HCP
DDD 332 for
direct operation by means of the HCP EID 320' is the same as inputting
directly into the HCP EID
320', which then directly transfers the instructions into the implanted system
1.
In the embodiment shown in fig. 25a, both the patient and the HCP has a
combined
hardware key 333', 333". The combined keys 333', 333" comprises a hardware
component
comprising a unique circuitry (providing the highest level of security), a
wireless NFC-transmitter
339 for transmitting a specific code (providing mid-level security), and a
printed QR-code 344 for
optical recognition of the card (providing the lowest level of security). The
HCP private key is
supplied by a HCP private key device 333" adapted to be provided to the HCP
EID external device
via at least one of; a reading slot or comparable for the HCP private key
device 333", an RFID
communication or other close distance wireless activation communication to
both the HCP EID
320' and the HCP DDD 332 if used. The HCP DDD 332 will be activated by such
HCP private key
device 333", which for example may comprise at least one of, a smartcard, a
key-ring device, a
watch an arm or wrist band a neckless or any shape device.
The HCP EID external device may comprise at least one of;
a reading slot or comparable for the HCP private key device,
an RFID communication and
other close distance wireless activation communication means
The HCP external device 320' may further comprise at least one wireless
transceiver 328
configured for communication with a data infrastructure server, DDI, through a
first network
protocol.
A dedicated data infrastructure server, DDI, is in one embodiment adapted to
receive
commands from said HCP external device 320' and may be adapted to rely the
received commands
without opening said commands directed to the patient external device 320",
the DDI 330
comprising one wireless transceiver configured for communication with said
patient external
device 320".
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The patient EID external device 320" is in one embodiment adapted to receive
the
commands relayed by the DDI, and further adapted to send these commands to the
implanted
medical device 100, which is adapted to receive commands from the HCP, Health
Care Provider,
via the DDI 330 to change the pre-programmed treatment steps of the implanted
system 1. The
patient EID is adapted to be activated and authenticated and allowed to
perform the commands by
the patient providing a patient private key device 333'. The patient's private
key device is in one
embodiment adapted to be provided to the patient external device by the
patient via at least one of;
a reading slot or comparable for the patient private key device 333', an RFID
communication or
other close distance wireless activation communication.
The patient EID external device, in one or more embodiments, comprises at
least one of;
a reading slot or comparable for the HCP private key device,
an RFID communication, or
other close distance wireless activation communication
The patient EID external device may in one or more embodiments comprise at
least one
wireless transceiver configured for communication with the implanted system
100 through a
second network protocol.
The patient's key 333' is in the embodiment shown in fig. 25a in the form of a
key card
having an interface for communicating with the P-EID 320", such that the key
card could be
inserted into a key card slot in the P-EID 320". The NFC-transmitter 339
and/or the printed QR-
code 344 can be used as means for accessing the control interface 334i of the
display device 334. In
addition, the display device 334 may require a pin-code and/or a biometric
input, such as face
recognition or fingerprint recognition.
The HCP's key 333", in the embodiment shown in fig. 25a is in the form of a
key card
having an interface for communicating with the HCP-EID 320', such that in one
embodiment the
key card could be inserted into a key card slot in the HCP-EID 320'. The NFC-
transmitter 339
and/or the printed QR-code 344 can be used as means for accessing the control
interface of the
HCP DDD 332. In addition, the HCP DDD 332 may require a pin-code and/or a
biometric input,
such as face recognition or fingerprint recognition.
In alternative embodiments, it is however conceivable that the hardware key
solution is
replaced by a two-factor authentication solution, such as a digital key in
combination with a PIN
code or a biometric input (such as face recognition and/or fingerprint
recognition). The key could
also be a software key, holding similar advance key features, such as the
Swedish Bank ID being a
good example thereof.
In the embodiment shown in fig. 25a, communication over the Internet takes
place over a
Dedicated Data Infrastructure (DDI) 330, running on a cloud service. The DDI
330 in this case
handles communication between the HCP DDD 332 and the P-EID 320'". however,
the more
likely scenario is that the HCP DDD 332 is closed down, such that only the
necessary functions of
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the control application can function on the HCP DDD 332. In the closed down
embodiment, the
HCP DDD 332 is only able to give the necessary commands to HCP EID 320' to
further update the
pre-programmed treatment steps of the Implant 100 via the P-EID 320" in direct
contact, or more
likely indirect contact via the DDI 332. If the patient is present locally,
the HCP EID may
communicate and act directly on the patient's implant. However, before
anything is accepted by the
implant, a patient private key device 333' has to be presented to the P EID
320" or HCP EID 320'
for maximum security.
The DDI 330 is logging information of the contact between the HCP and the
remote
control 320" via implant feedback data supplied from the implant to P-EID
320". Data generated
between the HCP and the patient's display device 334, as well as between the
HCP and auxiliary
devices 336 (such as tools for following up the patient's treatments e.g. a
blood pressure monitor)
are logged by the DDI 330. In some embodiments, although less likely, the HCP
DDD 332 may
also handle the communication between the patient's display device 334 and the
remote control
320". In fig. 25a, auxiliary devices 336 are connected to the P-EID as well
and can thus provide
input from the auxiliary devices 336 to the P-EID which can be used by the P-
EID for altering the
treatment or for follow up.
In all examples, the communication from the HCP to: the P-EID 320", the remote
control
320", the patient's display device 334 and the auxiliary devices 336 may be
performed using an
end-to-end encryption. In embodiments with end-to-end encryption, the
communication cannot be
decrypted by the DDI 330. In such embodiments, the DDI 330 acts as a router,
only passing on
encrypted communication from the HCP to various devices. This solution further
increases security
as the keys for decrypting the information rests only with the HCP and with
the device sending or
receiving the communication, which reduces the risk that an unencrypted signal
is intercepted by
an unauthorized device. The P-EID 320" may also only pass on encrypted
information.
In addition to acting as an intermediary or router for communication, the DDI
330 collects
data on the implanted medical device 100, relating to the treatment and to the
patient. The data may
be collected in an encrypted form, in an anonymized form or in an open form.
The form of the
collected data may depend on the sensitivity of the data or on the source from
which the data is
collected. In the embodiment shown in fig. 25a, the DDI 330 sends a
questionnaire to the patient's
display device 334. The questionnaire could comprise questions to the patient
related to the general
health of the patient, related to the way of life of the patient, or related
specifically to the treatment
provided by the implanted system 100 (such as for example a visual analogue
scale for measuring
pain). The DDI 330 could compile and/or combine input from several sources and
communicate
the input to the HCP which could use the provided information to create
instructions to the various
devices to be sent back over the DDI 330. The data collection performed by the
DDI 330 could also
be in the form a log to make sure that all communication between the units in
the system can be
back traced. Logging the communication ensures that all alterations to
software or the settings of
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the software, as well as the frequency and operation of the implanted system
100 can be followed.
Following the communication enables the DDI 330 or the HCP to follow the
treatment and react it
something in the communication indicates that the treatment does not provide
the intended results
or if something appears to be wrong with any of the components in the system.
If patient feedback
from the patient display device 334 indicates that a new treatment step of the
implant is needed,
such information must be confirmed by direct contact between HCP and patient.
In the specific embodiment disclosed in fig. 25a, the wireless connections
between the
different units are as follows. The wireless connection 411 between the
auxiliary device 336 and
the DDI 330 is based on WiFi or a mobile telecommunication regime or may be
sent to the DDI
330 via the P-EID 320" and the wireless connection 411 between the auxiliary
device 336 and the
patient's display device 334 is based on BT or any other communication pathway
disclosed herein.
The wireless connection 412 between the patient's display device 334 and the
DDI 330 is based on
WiFi or a mobile telecommunication regime. The wireless connection 413 between
the patient's
display device 334 and the remote control 320" is based on BT or any other
communication
pathway disclosed herein. The wireless connection 414 between the patient
remote control 320"
and the implanted system 100 is based on BT and UWB or any other communication
pathway
disclosed herein. The wireless connection 415 between the remote control 320"
and the DDI 330 is
likely to not be used, and if present be based on WiFi or a mobile
telecommunication regime. The
wireless connection 416 between the P-EID 320" and the implanted system 100 is
based on BT,
UWB and the charging signal or any other communication or energizing pathway
disclosed herein.
The wireless connection 417 between the P-EID 320" and the DDI 330 is based on
WiFi or a
mobile telecommunication regime. The wireless connection 418 between the HCP-
EID 320' and
the implanted system 100 is based on at least one of the BT, UWB and the
charging signal. The
wireless connection 419 between the P-EID 320" and the HCP DD 332 is based on
BT or any
other communication path disclosed herein. The wireless connection 420 between
the HPC-EID
320' and the DDI 330 is based on WiFi or a mobile telecommunication regime.
The wireless
connection 421 between the HPC DD 332 and the DDI 330 is normally closed and
not used and if
so based on WiFi or a mobile telecommunication regime. The wireless connection
422 between the
HCP-EID 320' and the HCP DD 332 is based on at least one of BT, UWB, local
network or any
other communication path disclosed herein.
The wireless connections specifically described in the embodiment shown in
fig. 25a may
however be replaced or assisted by wireless connections based on radio
frequency identification
(RFID), near field communication (NFC), Bluetooth, Bluetooth low energy (BLE),
or wireless
local area network (WLAN). The mobile telecommunication regimes may for
example be 1G, 2G,
3G, 4G, or 5G. The wireless connections may further be based on modulation
techniques such as
amplitude modulation (AM), frequency modulation (FM), phase modulation (PM),
or quadrature
amplitude modulation (QAM). The wireless connection may further feature
technologies such as
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time-division multiple access (TDMA), frequency-division multiple access
(FDMA), or code-
division multiple access (CDMA). The wireless connection may also be based on
infra-red (IR)
communication. The wireless connection may feature radio frequencies in the
high frequency band
(HF), very-high frequency band (VHF), and the ultra-high frequency band (UHF)
as well as
essentially any other applicable band for electromagnetic wave communication.
The wireless
connection may also be based on ultrasound communication to name at least one
example that does
not rely on electromagnetic waves.
Fig. 25a' also discloses a master private key 333" ' device that allow
issuance of new
private key device wherein the HCP or HCP admin have such master private key
333¨ device
adapted to be able to replace and pair a new patient private key 333' device
or HCP private key
device 333" into the system, through the HCP EID external device 320'.
A system configured for changing pre-programmed treatment settings of an
implantable
system 1, when implanted in a patient, from a distant remote location in
relation to the patient, will
be discussed in the following.
Fig. 25a' discloses a scenario in which at least one health care provider,
HCP, external
device 320' is adapted to receive a command from the HCP to change said pre-
programmed
treatment settings of an implanted system 1, further adapted to be activated
and authenticated and
allowed to perform said command by the HCP providing a HCP private key device
333". The HCP
EID external device 320' further comprising at least one wireless transceiver
328 configured for
communication with a patient EID external device 320", through a first network
protocol. The
system comprises the patient EID external device 320", the patient EID
external 320" device
being adapted to receive command from said HCP external device 320', and to
relay the received
command without modifying said command to the implanted system 1. The patient
EID external
device 320" comprises a wireless transceiver 328. The patient EID 320¨ is
adapted to send the
command to the implanted system 1, to receive a command from the HCP to change
said pre-
programmed treatment settings of the implanted system 1, and further to be
activated and
authenticated and allowed to perform said command by the patient providing a
patient private key
333' device comprising a patient private key.
Although wireless transfer is primarily described in the embodiment disclosed
with
reference to figs. 25a' the wireless communication between any of the external
device may be
substituted for wired communication. Also, some or all of the wireless
communication between an
external device and the implanted system 100 may be substituted for conductive
communication
using a portion of the human body as conductor.
Fig. 25b shows a portion of fig. 25a, in which some of the components have
been omitted
to outline a specific scenario. In the scenario outlined in fig. 25b, the
system is configured for
changing pre-programmed treatment settings of an implantable system 1, when
implanted in a
patient, from a distant remote location in relation to the patient. The system
of fig. 25b comprises at
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least one HCP EID 320' external device adapted to receive commands from the
HCP to change
said pre-programmed treatment settings of an implanted system 1. The HCP EID
320' external
device is further adapted to be activated and authenticated and allowed to
perform said command
by the HCP providing a HCP private key device 333" adapted to be provided to
the HCP EID
external device 320'. The private key device 333" is adapted to be provided to
the HCP EID
external device 320' via at least one of: a reading slot or comparable for the
HCP private key
device 333", and an RFID communication or other close distance wireless
activation
communication.
The HCP EID external device 320' comprises at least one of: a reading slot or
comparable
for the HCP private key device 333", an RFID communication, and other close
distance wireless
activation communication or electrical direct contact. The HCP EID external
device 320' further
comprises at least one wireless transceiver 328 configured for communication
with a dedicated data
infrastructure server (DDI) 330, through a first network protocol. The system
further comprises a
dedicated data infrastructure server (DDI) 330, adapted to receive command
from said HCP EID
external device 320', adapted to relay the received commands without modifying
said command to
a patient EID external device 320¨. The dedicated data infrastructure server
(DDI) 330 further
comprises a wireless transceiver 328 configured for communication with said
patient external
device. The system further comprises a patient EID external device 320" '
adapted to receive the
command relayed by the dedicated data infrastructure server (DDI) 330 and
further adapted to send
commands to the implanted system 100 and further adapted to receive commands
from the HCP
EID external device 320' via the dedicated data infrastructure server (DDI)
330 to change said pre-
programmed treatment settings of the implanted system 1. The patient EID
external device 320"
may further be adapted to be activated and authenticated and allowed to
perform said command by
the patient providing a patient private key device 333', which may be adapted
to be provided to the
patient EID external device 320¨ by the patient via at least one of: a reading
slot or comparable
for the patient private key device 333', an RFID communication or other close
distance wireless
activation communication or electrical direct contact. The patient EID
external device 320"
further comprises at least one of: a reading slot or comparable for the HCP
private key device, an
RFID communication and other close distance wireless activation communication
or electrical
direct contact. The patient EID external device 320" further comprises at
least one wireless
transceiver 328 configured for communication with the implanted system 100
through a second
network protocol. The implanted system 100 is in turn configured to treat the
patient or perform a
bodily function.
The scenario described with reference to fig. 25b may in alternative
embodiments be
complemented with additional units or communication connections, or combined
with any of the
scenarios described with reference to figures 25c ¨ 25e.
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Fig. 25c shows a portion of fig. 25a, in which some of the components have
been omitted
to outline a specific scenario. In the scenario outlined in fig. 25c, a system
configured for changing
pre-programmed treatment settings of an implantable system 100 is disclosed.
The changing of the
pre-programmed treatment settings is performed by a health care provider (HCP)
in the physical
presence of the patient. The system comprises at least one HCP EID external
device 320' adapted
to receive commands from the HCP, directly or indirectly, to change said pre-
programmed
treatment settings in steps of an implantable system 1, when implanted. The
HCP EID external
device 320' is further adapted to be activated, authenticated, and allowed to
perform said command
by the HCP providing a HCP private key device 333" comprising a HCP private
key. The HCP
private key device in the embodiment of fig. 25c comprises at least one of: a
smart card, a keyring
device, a watch, a arm or wrist band, a necklace, and any shaped device. The
HCP EID external
device 320' is adapted to be involved in at least one of: receiving
information from the implant
100, receiving information from a patient remote external device 336,
actuating the implanted
system 1, changing pre-programmed settings, and updating software of the
implantable system 1,
when implanted. The HCP EID external device 320' is adapted to be activated,
authenticated, and
allowed to perform said command also by the patient, the system comprises a
patient private key
device 333' comprising a patient private key. The patient private key device
333' may comprise at
least one of: a smart card, a keyring device, a watch, a arm or wrist band, a
necklace, and any
shaped device. The HCP private key 333" and the patient's private key may be
required for
performing said actions by the HCP EID external device 320' to at least one
of: receive information
from the implant 100, to receive information from a patient remote external
device 336, to actuate
the implanted system 1, to change pre-programmed settings, and to update
software of the
implantable system 1, when the implantable system 100 is implanted.
Fig. 25c also outlines a scenario in which the system is configured for
changing pre-
programmed treatment settings in steps of an implantable medical device, when
implanted in a
patient, by a health care provider, HCP, wherein the patient may be located at
a remote location, or
on a distance. The system may comprise: at least one HCP EID external device
320' adapted to
receive a command from the HCP, directly or indirectly, to change said pre-
programmed treatment
settings in steps of an implanted medical device The HCP EID external device
320' is further
adapted to be activated, authenticated, and allowed to perform said command by
the HCP. The
action by the HCP EID external device 320' to change pre-programmed settings
in the implant 100
and to update software of the implantable medical device 100, when the
implantable medical
device 100 is implanted, is adapted to be authenticated by a HCP private key
device 333" and a
patient private key device 333'.
The scenario described with reference to fig. 25c may in alternative
embodiments be
complemented with additional units or communication connections, or combined
with any of the
scenarios described with reference to figures 25b, or 25d ¨ 25e.
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Fig. 25d shows a portion of fig. 25a, in which some of the components have
been omitted
to outline a specific scenario. In the scenario outlined in fig. 25d, a system
configured to change
pre-programmed and pre-selected treatment actions of an implantable system 100
by a command
from the patient is described. The system comprises an implantable system 1, a
patient remote
external device 320", and a wireless transceiver 328 configured for
communication with the
implantable system 1, when the system 100 is implanted, through a second
network protocol. The
system further comprises a remote display portal interface 334i configured to
receive content
delivered from the patient remote external device 320" to expose buttons to
express the will to
actuate the functions of the implanted system 100 by the patient through the
patient remote external
device 320". The remote external device 320" is further configured to present
the display portal
remotely on a patient display device 334 allowing the patient to actuate the
functions of the
implanted system 100 through the display portal of the patient remote external
device 320"
visualised on the patient display device 334. In fig. 25d, a further wireless
connection 423 between
the patient remote external device 320" and the patient EID external device
320" is provided.
This further wireless connection 423 could be a wireless connection according
to any one of the
wireless signaling methods and protocols described herein, and the
communication can be
encrypted.
The scenario described with reference to fig. 25d may in alternative
embodiments be
complemented with additional units or communication connections, or combined
with any of the
scenarios described with reference to figures 25b, 25c, or 25e.
Fig. 25e shows a portion of fig. 25a, in which some of the components have
been omitted
to outline a specific scenario. In the scenario outlined in fig. 25e, a system
configured for providing
information from an implantable medical system 1, when implanted in a patient,
from a distant
remote location in relation to the patient is described. The system comprises
at least one patient
EID external device 320" adapted to receive information from the implant 100,
and to send such
information further on to a server or dedicated data infrastructure, DDI, 330.
The patient EID
external device 320" is further adapted to be activated and authenticated and
allowed to receive
said information from the implanted system 100 by the patient providing a
private key. The patient
private key device comprises the private key adapted to be provided to the
patient EID external
device 320" via at least one of: a reading slot or comparable for the patient
private key device, an
RFID communication or other close distance wireless activation communication
or direct electrical
connection, The patient EID external device 320" comprises at least one of: a
reading slot or
comparable for the patient private key device, an RFID communication and other
close distance
wireless activation communication or direct electrical contact. The patient
EID external device
320" further comprises at least one wireless transceiver 328 configured for
communication with
the DDI 330, through a first network protocol.
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The scenario described with reference to fig. 25e may in alternative
embodiments be
complemented with additional units or communication connections, or combined
with any of the
scenarios described with reference to figures 25b ¨ 25d.
Fig. 25f shows a portion of fig. 25a, in which some of the components have
been omitted to
outline a specific scenario. In the scenario outlined in fig. 25f a system
configured for changing
pre-programmed treatment settings in steps of an implantable system 1, when
implanted in a
patient, by a health care provider, HCP, either in the physical presence of
the patient or remotely
with the patient on distance is described. The system comprises at least one
HCP EID external
device 320' adapted to receive a command directly or indirectly from the HCP
to change said pre-
programmed treatment settings in steps of the implantable system 1, when
implanted, wherein the
HCP EID external device 320' is further adapted to be activated,
authenticated, and allowed to
perform said command by the HCP providing a HCP private key device comprising
a HCP private
key. The HCP private key comprises at least one of: a smart card, a keyring
device, a watch, an arm
or wrist band, a necklace, and any shaped device. The system further comprises
a patient private
key device comprising a patient private key comprising at least one of: a
smart card, a keyring
device, a watch, an arm or wrist band, a necklace, and any shaped device. Both
the HCP and
patient private key is required for performing said action by the HCP EID
external device 320' to
change the pre-programmed settings in the system 100 and to update software of
the implantable
system 1, when the implantable system 100 is implanted. The patient private
key is adapted to
activate, be authenticated, and allowed to perform said command provided by
the HCP, either via
the HCP EID external device or when the action is performed remotely via a
patient EID external
device 320'. In the embodiment shown in fig. 25f, the communication is routed
over the DDI
server 330.
The scenario described with reference to fig. 25f may in alternative
embodiments be
complemented with additional units or communication connections, or combined
with any of the
scenarios described with reference to figures 25b ¨ 25e.
Fig. 25g shows an overview of an embodiment of the system, similar to the one
described
with reference to fig. 25a, the difference being that the HCP EID and the HCP
DDD are combined
into a single device.
Fig. 25h shows an overview of an embodiment of the system, similar to that
described with
reference to fig. 25a, the difference being that the HCP EID external device
320" and the HCP
DDD 332 are combined into a single device and the P-EID external device 320"
and the patient
remote control external device 320" are combined into a single device.
One probable scenario / design of the communication system is for the purpose
of changing
pre-programmed treatment settings of an implantable medical device, when
implanted in a patient,
from a distant remote location in relation to the patient. The system
comprises at least one health
care provider, HCP, external device 320' adapted to receive a command from the
HCP to change
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said pre-programmed treatment settings of an implanted system 1. The HCP
external device 320'
is further adapted to be activated and authenticated and allowed to perform
said command by the
HCP providing a HCP private key device 333", which may be adapted to be
provided to an HCP
EID external device via at least one of: a reading slot or comparable for the
HCP private key
device, a RFID communication or other close distance wireless activation
communication. The
HCP EID external device comprises at least one of: a reading slot or
comparable for the HCP
private key device, a RFID communication, and other close distance wireless
activation
communication or electrical direct contact. The HCP EID external device
further comprises at least
one wireless transceiver configured for communication with a patient EID
external device, through
a first network protocol, wherein the system comprises the patient EID
external device, the patient
EID external device being adapted to receive command from said HCP external
device, and to
relay the received command without modifying said command to the implanted
medical device.
The patient EID external device comprising one wireless transceiver configured
for communication
with said patient external device. The patient EID is adapted to send the
command to the implanted
medical device, to receive a command from the HCP to change said pre-
programmed treatment
settings of the implanted medical device, and further to be activated and
authenticated and allowed
to perform said command by the patient providing a patient private key device
comprising a patient
private key.
Although the different scenarios outlined in figures 25b ¨ 25h are described
with specific
units and method of signaling, these scenarios may very well be combined with
each other or
complemented with additional units or communication connections. The
embodiments described
herein may advantageously be combined.
A computer program product of, or adapted to be run on, an internal computing
unit or an
external device is also provided, which comprises a computer-readable storage
medium with
instructions adapted to make the internal computing unit and/or the external
device perform the
actions as described in any embodiment or example above.
Figure 26 shows a frontal view of the abdomen of the patient when the medical
device 100
according to any of above described embodiments, such as the electrical
stimulation device 110
and/or the signal damping device 120 shown in figures 4-8, or the entire
system, or parts of the
system, shown in figure 11, has been implanted. This is however only an
example of an
embodiment and it is clear that any of the embodiments of the medical device
disclosed herein can
be implanted and connected in the manner described with reference to figure
26. The medical
device 100 is in the embodiment shown in figure 26 operated by a remote unit
140 which in the
embodiment shown in figure 26 may correspond to the remote unit 140 of the
embodiments
discussed above in connection with figures 24a-f and 25. This is however only
an example of a
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remote unit for operation of the medical device 100 and it is clear that any
of the embodiments of
remote units disclosed herein can be implanted and connected in the manner
described with
reference to figure 26.
The remote unit 140 may comprise a first unit 141', a second unit 141", and a
connecting
portion 142, mechanically connecting the first and second units 141',141". The
first unit 141' is in
the embodiment shown in fig. 26 placed on the inside of muscular tissue MT of
the abdominal wall
AW of the patient, whereas the second unit 141" is placed on the outside of
the muscular tissue
MT of the abdominal wall AW, in the subcutaneous tissue ST. As such, the
connecting portion 142
travels through a created hole in, or natural orifice between, the muscles of
the muscular tissue
1 0 MT. A cross-sectional area of the connecting portion 142, in a plane in
the extension of the
muscular tissue MT is smaller than a cross-sectional area of the first and
second units 141',141",
parallel to the cross-sectional area of the connecting portion 142. The cross-
sectional areas of the
first and second units 141',141" are also larger than the created hole or
natural orifice though
which the connecting portion 142 is placed. As such, the first and second
units 141',141" are
unable to pass through the created hole or natural orifice and is as such
fixated to the muscular
tissue MT of the abdominal wall. This enables the remote unit 140 to be
suspended and fixated to
the muscle tissue MT of the abdominal wall AW.
In the embodiment shown in fig. 26, the connecting portion 142, is a
connecting portion
142 having a circular cross-section and an axial direction AD extending from
the first unit 141' to
the second unit 141". The plane in the extension of the muscular tissue MT, is
in the embodiment
of fig. 26 perpendicular to the axial direction AD of the connecting portion
142 extending from the
first unit 141' to the second unit 141".
As is further described with reference to fig. 26, the controller may be
placed in the first
unit 141', and the implantable energy storage unit is placed in the second
unit 141". The controller
and the implantable energy storage unit are electrically connected to each
other by means of a lead
running in the connecting portion 142, such that electrical energy and
communication can be
transferred from the second 141" to the first unit 141', and vice versa. In
the embodiment of fig.
26, the second unit 141" may further comprise a wireless energy receiver for
receiving wireless
energy for charging the implantable energy storage unit and/or for powering
the medical device
100, and a transceiver for receiving and/or transmitting wireless signals
to/from the outside the
body. Further features and functions of the controller and the implantable
energy storage unit are
further described above reference to figs. 24a-f and 25.
The abdominal wall AW is in most locations generally formed by a set of layers
of skin,
fat/fascia, muscles and the peritoneum. The deepest layer in the abdominal
wall AW is the
peritoneum PT, which covers many of the abdominal organs, for example the
large and small
intestines. The peritoneum PT is a serous membrane composed of a layer of
mesothelium
supported by a thin layer of connective tissue and serves as a conduit for
abdominal organ's blood
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vessels, lymphatic vessels, and nerves. The area of the abdomen enclosed by
the peritoneum PT is
called the intraperitoneal space. The tissue and organs within the
intraperitoneal space are called
"intraperitoneal" (e.g., the stomach and intestines). The tissue and organs in
the abdominal cavity
that are located behind the intraperitoneal space are called "retroperitoneal"
(e.g., the kidneys), and
tissue and organs located below the intraperitoneal space are called
"subperitoneal" or
"infraperitoneal" (e.g., the bladder).
The peritoneum PT is connected to a layer of extraperitoneal fat EF which is
connected to
a layer or transversalis fascia TF. Connected to the transversalis fascia TF,
at the area of the
abdominal wall AW at which the section is extracted, is muscle tissue MT
separated by layers of
deep fascia DF. The deep fascia DF between the layers of muscle is thinner
than the transversalis
fascia TF and the Scarpa's fascia SF placed on the outside of the muscle
tissue MT. Both the
transversalis fascia TF and the Scarpa's fascia SF are relatively firm
membranous sheets. At the
area of the abdominal wall AW at which the section is extracted, the muscle
tissue MT is
composed of the transverse abdominal muscle TM (transversus abdominis), the
internal oblique
muscle IM (obliquus internus) and the external oblique muscle EM (obliquus
externus). In other
areas of the abdominal wall AW, the muscle tissue could also be composed of
the rectus abdominis
and the pyramidalis muscle.
The layer outside of the muscle tissue MT, beneath the skin SK of the patient
is called
subcutaneous tissue ST, also called the hypodermis, hypoderm, subcutis or
superficial fascia. The
main portion of the subcutaneous tissue ST is made up of Camper's fascia which
consists primarily
of loose connective tissue and fat. Generally, the subcutaneous tissue ST
contains larger blood
vessels and nerves than those found in the skin.
Placing the remote unit 140 at an area of the abdomen is advantageous as the
intestines are
easily displaced for making sufficient room for the remote unit 140, without
the remote unit 140
affecting the patient too much in a sensational or visual way. Also, the
placement of the remote unit
140 in the area of the abdomen makes it possible to fixate the remote unit 140
to the muscle tissue
MT of the abdomen for creating an attachment keeping the remote unit 140
firmly in place. In the
embodiment shown in fig. 26, the first unit 141' of the remote unit 140 is
placed on the left side of
the patient in between the peritoneum PT and the muscle tissue MT. The second
unit 141" is
placed in the subcutaneous tissue ST between the muscle tissue MT and the skin
SK of the patient.
Placing the second unit 141" subcutaneously enables easy access to the second
unit 141" for e.g.
wireless communication using a wireless transceiver placed in the second unit
141", wireless
charging of an implantable storage unit using a wireless energy receiver
placed in the second unit
141", manual manipulation of for example a push button placed in the second
unit 141", or
maintenance or replacement of the second unit 141" via a small incision in the
skin SK at the
second unit 141".
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In the embodiment shown in fig. 26, the electrical leads 135 running inside of
protective a
cover 136 transports electrical power and/or electrical signals, such as an
electrical stimulation
signal, an electric damping signal, or a sensor signal, as previously
described, from the remote unit
140 to the main portion M of the medical device 100 arranged for instance at
the renal artery. The
electrical leads 135 may run between the peritoneum PT and the muscle tissue
MT vertically until
the lead 135 reaches the height of the main portion M of the medical device
100. At this height, the
lead 135 may enter the peritoneum PT and travel substantially horizontally to
the main portion M
of the medical device 100. As such, the lead 135 is placed inside of the
intraperitoneal space for as
short distance as possible which reduces the risk that implanted, foreign
body, elements disturb the
intraperitoneal organs, reducing the risk of damage to organs, and reducing
the risk that foreign
body elements cause ileus.
In the embodiment shown in fig. 26, the connecting portion 142 connects the
first and
second units 141',141" though three layers of muscle tissue MT, namely tissue
of the transverse
abdominal muscle TM, the internal oblique muscle IM and the external oblique
muscle EM. In
alternative embodiments, it is however conceivable that the first unit 141' is
placed in between
layers of muscle, such as between tissue of the transverse abdominal muscle
TM, the internal
oblique muscle IM, or between the internal oblique muscle IM and the external
oblique muscle
EM. As such, it is conceivable that in alternative embodiments, the connecting
portion 142
connects the first and second units 141',141" through two layers of muscle
tissue MT, or through
one layer of muscle tissue MT.
In alternative embodiments, it is furthermore conceivable that the second
portion 141" is
placed in between layers of muscle, such as between tissue of external oblique
muscle EM and the
internal oblique muscle IM, or between the internal oblique muscle IM and the
transverse
abdominal muscle TM.
In embodiments in which the medical device is hydraulically remotely operable
(such as
further described with reference to the sensor in fig. 13a-b), flexible wires
135 may be provided,
running inside of protective a cover 136 for transporting linear mechanical
force from the remote
unit 140 to the main portion M shown in fig. 26 is replaced by conduits (609a-
d in fig. 13a-b) for
conducting hydraulic fluid for transferring force from a portion of the
hydraulic operation device
placed in the remote unit 140 to a portion of the operation device placed in
the main portion M of
the medical device 100 hydraulically.
Figs. 27 and 28 show an embodiment of a remote unit 140 which may be used in
combination with any of the hydraulically operable medical devices disclosed
herein. The remote
unit 140 is configured to be held in position by a tissue portion 610 of a
patient. The remote unit
140 comprises a first portion 141' configured to be placed on a first side 612
of the tissue portion
610, the first portion 141' having a first cross-sectional area Al in a first
plane P1 and comprising a
first surface 614 configured to face a first tissue surface 616 of the first
side 612 of the tissue
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portion 610. The remote unit 140 further comprises a second portion 141"
configured to be placed
on a second side 618 of the tissue portion 610, the second side 618 opposing
the first side 612, the
second portion 141" having a second cross-sectional area A2 in a second plane
P2 and comprising
a second surface 620 configured to engage a second tissue surface 622 of the
second side 618 of the
tissue portion 610. The remote unit 140 further comprises a connecting portion
142 configured to
be placed through a hole in the tissue portion 610 extending between the first
and second sides 612,
618 of the tissue portion 610. The connecting portion 142 here has a third
cross-sectional area A3
in a third plane P3 and a fourth cross-sectional area A4 in a fourth plane P4
and a third surface 624
configured to engage the first tissue surface 616 of the first side 612 of the
tissue portion 610. The
.. connecting portion 142 is configured to connect the first portion 141' to
the second portion 141".
The connecting portion 142 thus has a portion being sized and shaped to fit
through the
hole in the tissue portion 610, such portion having the third cross-sectional
area A3. Furthermore,
the connecting portion 142 may have another portion being sized and shaped to
not fit through the
hole in the tissue portion 610, such portion having the fourth cross-sectional
area A4. Likewise, the
.. second portion 141" may have a portion being sized and shaped to not fit
through the hole in the
tissue portion 610, such portion having the second cross-sectional area A2.
Thus, the connecting
portion 142 may cooperate with the second portion 141" to keep the device in
place in the hole of
the tissue portion 610.
In the embodiment illustrated in fig. 27, the first portion 141' is configured
to detachably
connect, i.e. reversibly connect to the connecting portion 142 by a mechanical
and/or magnetic
mechanism. In the illustrated embodiment, a mechanic mechanism is used,
wherein one or several
spring-loaded spherical elements 601 lock in place in a groove 603 of the
connecting portion 142
when the first portion 141' is inserted into the connecting portion 142. Other
locking mechanisms
are envisioned, including corresponding threads and grooves, self-locking
elements, and twist and
lock fittings.
The remote unit 140 is configured such that, when implanted, the first portion
141' will be
placed closer to an outside of the patient than the second portion 141".
Furthermore, in some
implantation procedures the remote unit 140 may be implanted such that space
will be available
beyond the second portion, i.e. beyond the second side 618 of the tissue
portion 610, whereas there
may be as much space on the first side 612 of the tissue portion. Furthermore,
tissue and/or skin
may exert a force on the first portion 141" towards the tissue portion 610 and
provide for that the
second portion 141" does not travel through the hole in the tissue portion
towards the first side 612
of the tissue portion. Thus, it is preferably if the remote unit 140 is
primarily configured to prevent
the first portion 141" from travelling through the hole in the tissue portion
612 towards the second
side 618 of the tissue portion 610.
The first portion 141' may further comprise one or several connections 605 for
transferring
energy and/or communication signals to the second portion 141" via the
connecting portion 142.
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The connections 605 in the illustrated embodiment are symmetrically arranged
around a
circumference of a protrusion 607 of the first portion 141' and are arranged
to engage with a
corresponding connection 609 arranged at an inner surface of the connecting
portion 142. The
protrusion 607 may extend in a central extension Cl of the central portion
142. The second portion
141" may also comprise one or several connections 611, which may be similarly
arranged and
configured as the connections 605 of the first portion 141'. For example, the
one or several
connections 611 may engage with the connection 609 of the connecting portion
142 to receive
energy and/or communication signals from the first portion 141'. Although the
protrusion 607 is
illustrated separately in Figs. 27, it is to be understood that the protrusion
607 may be formed as
one integral unit with the first portion 141'.
Other arrangements of connections are envisioned, such as asymmetrically
arranged
connections around the circumference of the protrusion 607. It is also
envisioned that one or
several connections may be arranged on the first surface 614 of the first
portion 141', wherein the
connections are arranged to engage with corresponding connections arranged on
the opposing
surface 613 of the connecting portion. Such connections on the opposing
surface 613 may cover a
relatively large area as compared to the connection 609, thus allowing a
larger area of contact and a
higher rate and/or signal strength of energy and/or communication signal
transfer. Furthermore, it
is envisioned that a physical connection between the first portion 141',
connecting portion 142 and
second portion 141" may be replaced or accompanied by a wireless arrangement,
as described
further in other parts of the present disclosure.
Any of the first surface 614 of the first portion 141', the second surface 620
of the second
portion 141', the third surface 624 of the connecting portion 142, and an
opposing surface 613 of
the connecting portion 142, may be provided with at least one of ribs, barbs,
hooks, a friction
enhancing surface treatment, and a friction enhancing material, to facilitate
the remote unit 140
being held in position by the tissue portion, and/or to facilitate that the
different parts of the device
are held in mutual position.
The opposing surface 613 of the connecting portion 142 and the first surface
614 of the
first portion 141' may provide, fully or partly, a connection mechanism to
detachably connect the
first portion 141' to the connecting portion 142. Such connection mechanisms
have been described
previously in the presented disclosure and can be arranged on one or both of
the opposing surface
613 and the first surface 614 and will not be further described here.
The opposing surface 613 may be provided with a recess configured to house at
least part
of the first portion 141'. In particular, such recess may be configured to
receive at least a portion of
the first portion 141', including the first surface 614. Similarly, the first
surface 614 may be
provided with a recess configured to house at least part of the connecting
portion 142. In particular,
such recess may be configured to receive at least a portion of the connecting
portion 142, and in
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some embodiments such recess may be configured to receive at least one
protruding element to at
least partially enclose at least one protruding element or flange.
In the illustrated embodiment, the first portion 141' comprises a first energy
storage unit
304a and a controller 300a comprising one or several processing units
connected to the first energy
storage unit 304a. The first energy storage unit 304a may be rechargeable by
wireless transfer of
energy. In some embodiments, the first energy storage unit 304a may be non-
rechargeable. Upon
reaching the life-time end of such first energy storage, a replacement first
portion comprising a new
first energy storage unit may simply be swapped in place for the first portion
having the depleted
first energy storage unit. The second portion 141" may further comprise a
controller 300b
comprising one or several processing units.
As will be described in other parts of the present disclosure, the first
portion 141' and the
second portion 141" may comprise one or several functional parts, such as
receivers, transmitters,
transceivers, control units, processing units, sensors, energy storage units,
sensors, etc.
The remote unite 140 may be non-inflatable.
As can be seen in figure 28, the first, second, third and fourth planes Pl,
P2, P3 and P4, are
parallel to each other. Furthermore, in the illustrated embodiment, the third
cross-sectional area A3
is smaller than the first, second and fourth cross-sectional areas Al, A2 and
A4, such that the first
portion 141', second portion 141" and connecting portion 142 are prevented
from travelling
through the hole in the tissue portion 610 in a direction perpendicular to the
first, second and third
planes Pl, P2 and P3. Hereby, the second portion 141" and the connecting
portion 142 can be held
in position by the tissue portion 610 of the patient also when the first
portion 141' is disconnected
from the connecting portion 142.
It is to be understood that the illustrated planes Pl, P2, P3 and P4 are
merely an example of
how such planes may intersect the remote unit 140. Other arrangements of
planes are possible, as
.. long as the conditions above are fulfilled, i.e. that the portions have
cross-sectional areas, wherein
the third cross-sectional area in the third plane P3 is smaller than the
first, second and fourth cross-
sectional areas, and that the planes Pl, P2, P3 and P4 are parallel to each
other.
The connecting portion 142 illustrated in fig. 28 may be defined as a
connecting portion
142 comprising a flange 626. The flange 626 thus comprises the fourth cross-
sectional area A4
such that the flange 626 is prevented from travelling through the hole in the
tissue portion 610 in a
direction perpendicular to the first, second and third planes Pl, P2 and P3.
The flange 626 may
protrude in a direction parallel to the first, second, third and fourth planes
Pl, P2, P3 and P4. This
direction is perpendicular to a central extension Cl of the connecting portion
142.
The connecting portion 142 is not restricted to flanges, however. Other
protruding elements
may additionally or alternatively be incorporated into the connecting portion
142. As such, the
connecting portion 142 may comprise at least one protruding element comprising
the fourth cross-
sectional area A4, such that the at least one protruding element is prevented
from travelling through
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the hole in the tissue portion 610, such that the second portion 141" and the
connecting portion 142
can be held in position by the tissue portion 610 of the patient also when the
first portion 141' is
disconnected from the connecting portion 142. The at least one protruding
element may protrude in
a direction parallel to the first, second, third and fourth planes Pl, P2, P3
and P4. This direction is
perpendicular to a central extension Cl of the connecting portion 142. As
such, the at least one
protruding element will also comprise the third surface configured to engage
the first tissue surface
616 of the first side 612 of the tissue portion 610.
The connecting portion 142 may comprise a hollow portion 628. The hollow
portion 628
may provide a passage between the first and second portions 141', 141". In
particular, the hollow
portion 628 may house a conduit for transferring fluid from the first portion
141' to the second
portion 141". The hollow portion 628 may also comprise or house one or several
connections or
electrical leads for transferring energy and/or communication signals between
the first portion 141'
and the second portion 141".
Some relative dimensions of the remote unit 140 will now be described with
reference to
figs. 28 and 29a ¨ 29c, however it is to be understood that these dimensions
may also apply to other
embodiments of the remote unit 140. The at least one protruding element 626
may have a height
HF in a direction perpendicular to the fourth plane being less than a height
H1 of the first portion
141' in said direction. The height HF may alternatively be less than half of
said height H1 of the
first portion 141' in said direction, less than a quarter of said height H1 of
the first portion 141' in
said direction, or less than a tenth of said height H1 of the first portion
141' in said direction.
The height H1 of the first portion 141' in a direction perpendicular to the
first plane may be
less than a height H2 of the second portion 141" in said direction, such as
less than half of said
height H2 of the second portion 141"in said direction, less than a quarter of
said height H2 of the
second portion 141"in said direction, or less than a tenth of said height H2
of the second portion
141" in said direction.
The at least one protruding element 626 may have a diameter DF in the fourth
plane being
one of less than a diameter D1 of the first portion 141' in the first plane,
equal to a diameter D1 of
the first portion 141' in the first plane, and larger than a diameter D1 of
the first portion 141' in the
first plane. Similarly, the cross-sectional area of the at least one
protruding element 626 in the
fourth plane may be less, equal to, or larger than a cross-sectional area of
the first portion in the
first plane.
The at least one protruding element 626 may have a height HF in a direction
perpendicular
to the fourth plane being less than a height HC of the connecting portion 142
in said direction.
Here, the height HC of the connecting portion 142 is defined as the height
excluding the at least
one protruding element, which forms part of the connecting portion 142. The
height HF may
alternatively be less than half of said height HC of the connecting portion
142 in said direction, less
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140
than a quarter of said height HC of the connecting portion 142 in said
direction, or less than a tenth
of said height HC of connecting portion 142 in said direction.
As shown in Figs. 29a-c the at least one protruding element 626 may have an
annular
shape, such as a disk shape. However, elliptical, elongated and/or other
polyhedral or irregular
.. shapes are also possible. In the illustrated embodiment, the at least one
protruding element 626
extends a full revolution around the center axis of the connecting portion
142. However, other
arrangements are possible, wherein the at least one protruding element 626
constitute a partial
circle sector. In the case of a plurality of protruding elements, such
plurality of protruding elements
may constitute several partial circle sectors.
As shown in Figs. 30a-b, 3 la-b and 32a-b, the connecting portion 142 may
comprise at
least two protruding elements 626, 627. For example, the connecting portion
142 may comprise at
least three, four, five, fix, seven, eight, nine, ten protruding elements, and
so on. In such
embodiments, the at least two protruding elements 626, 627 may together
comprise the fourth
cross-sectional area, thus providing a necessary cross-sectional area to
prevent the first portion and
second portion from travelling through the hole in the tissue portion.
The at least two protruding elements 626, 627 may be symmetrically arranged
about the
central axis of the connecting portion, as shown in Figs. 3 la-b, or
asymmetrically arranged about
the central axis of the connecting portion, as shown in Figs. 32a-b. In
particular, the at least two
protruding elements 626, 627 may be asymmetrically arranged so as to be
located towards one side
of the connecting portion 142, as shown in Figs. 32a-b. The arrangement of
protruding element(s)
may allow the remote unit 140, and in particular the connecting portion 142,
to be placed in areas
of the patient where space is limited in one or more directions.
The first portion 141' may comprise a first energy storage unit for supplying
the remote
unit 140 with energy.
Although one type or embodiment of the implantable remote unit 140, may fit
most
patients, it may be necessary to provide a selection of implantable remote
units 140 or portions to
be assembled into implantable remote units 140. For example, some patients may
require different
lengths, shapes, sizes, widths or heights depending on individual anatomy.
Furthermore, some parts
or portions of the implantable remote units 140 may be common among several
different types or
.. embodiments of implantable energized medical devices, while other parts or
portions may be
replaceable or interchangeable. Such parts or portions may include energy
storage devices,
communication devices, fluid connections, mechanical connections, electrical
connections, and so
on.
To provide flexibility and increase user friendliness, a kit of parts may be
provided. The kit
preferably comprises a group of one or more first portions, a group of one or
more second portions,
and a group of one or more connecting portions, the first portions, second
portions and connecting
portions being embodied as described throughout the present disclosure. At
least one of the groups
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comprises at least two different types of said respective portions. By the
term "type", it is hereby
meant a variety, class or embodiment of said respective portion.
In some embodiments of the kit, the group of one or more first portions, the
group of one or
more second portions, and the group of one or more connecting portions,
comprise separate parts
which may be assembled into a complete implantable energized medical device.
The implantable
energized medical device may thus be said to be modular, in that the first
portion, the second
portion, and/or the connecting portion may be interchanged for another type of
the respective
portion.
In some embodiments, the connecting portion form part of the first portion or
the second
portion.
With reference to Fig. 33, the kit for assembling the implantable energized
medical device
comprises a group 650 of one or more first portions 141', in the illustrated
example a group of one
first portion 141', a group 652 of one or more connecting portions 142, in the
illustrated example a
group of three connecting portions 142, and a group 654 of one or more second
portions 141", in
the illustrated example a group of two second portions 141". For simplicity,
all types and
combinations of first portions, second portions and connecting portions will
not be illustrated or
described in detail.
Accordingly, the group 652 of one or more connecting portions 142 comprise
three
different types of connecting portions 142. Here, the different types of
connecting portions 142
comprise connecting portions 142a, 142b, 142c having different heights.
Furthermore, the group
654 of one or more second portions 141" comprise two different types of second
portions 141".
Here, the different types of second portions 141" comprise a second portion
141"a being
configured to eccentrically connect to a connecting portion, having a first
end and a second end as
described in other parts of the present disclosure, wherein the second end of
the second portion
141"a comprises or is configured for at least one connection for connecting to
an implant being
located in a caudal direction from a location of the implantable energized
medical device in the
patient, when the device is assembled. In the illustrated figure, the at least
one connection is
visualized as a lead or wire. However, other embodiments are possible,
including the second end
comprising a port, connector or other type of connective element for
transmission of power, fluid,
and/or signals.
Furthermore, the different types of second portions 141" comprise a second
portion 141"b
being configured to eccentrically connect to a connecting portion, having a
first end and a second
end as described in other parts of the present disclosure, wherein the first
end of the second portion
141"b comprises or is configured for at least one connection for connecting to
an implantable
.. medical device for stretching the stomach wall of the patient, being
located in a cranial direction
from a location of the implantable energized medical device in the patient,
when the device is
assembled. In the illustrated figure, the at least one connection is
visualized as a lead or wire.
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However, other embodiments are possible, including the first end comprising a
port, connector or
other type of connective element for transmission of power, fluid, and/or
signals.
Thus, the implantable energized medical device may be modular, and different
types of
devices can be achieved by selecting and combining a first portion 141', a
connecting portion 142,
and a second portion 141", from each of the groups 652, 654, 656.
In the illustrated example, a first remote unit 140a is achieved by a
selection of the first
portion 141', the connecting portion 142a, and the second portion 141"a. Such
remote unit 140a
may be particularly advantageous in that the connecting portion 142a may be
able to extend
through a thick layer of tissue to connect the first portion 141' and the
second portion 141"a.
Another remote unit 140b is achieved by a selection of the first portion 141',
the connecting
portion 142c, and the second portion 141"b. Such device may be particularly
advantageous in that
the connecting portion 142c has a smaller footprint than the connecting
portion 142a, i.e.
occupying less space in the patient. Owing to the modular property of the
remote units 140a and
140b, a practician or surgeon may select a suitable connecting portion as
needed upon having
assessed the anatomy of a patient. Furthermore, since remote units 140a and
140b share a common
type of first portions 141', it will not be necessary for a practician or
surgeon to maintain a stock of
different first portions (or a stock of complete, assembled devices) merely
for the sake of achieving
a device having different connections located in the first end or second end
of the second portion
respectively, as in the case of second portions 141"a, 141"b.
The example illustrated in Fig. 33 is merely exemplifying to display the idea
of a modular
implantable remote unit 140. The group 650 of one or more first portions 141'
may comprise a
variety of different features, such as first portions with or without a first
energy storage unit, with
or without a first wireless energy receiver unit for receiving energy
transmitted wirelessly by an
external wireless energy transmitter, with or without an internal wireless
energy transmitter, and/or
other features as described throughout the present disclosure. Other features
include different
height, width, or length of the first portion. It is to be understood that
first portions having one or
more such features may be combined with a particular shape or dimensions to
achieve a variety of
first portions. The same applies to connecting portions and second portions.
With reference to Fig. 34, an embodiment of an implantable remote unit 140,
will be
described. The remote unit 140 is configured to be held in position by a
tissue portion 610 of a
patient. The remote unit 140 comprises a first portion 141' configured to be
placed on a first side of
the tissue portion 610, the first portion 141' having a first cross-sectional
area in a first plane and
comprising a first surface configured to face and/or engage a first tissue
surface of the first side of
the tissue portion 610. The device 140 further comprises a second portion 141"
configured to be
placed on a second side of the tissue portion 610, the second side opposing
the first side, the second
portion 141" having a second cross-sectional area in a second plane and
comprising a second
surface configured to engage a second tissue surface of the second side of the
tissue portion 610.
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The remote unit 140 further comprises a connecting portion 142 configured to
be placed through a
hole in the tissue portion 610 extending between the first and second sides of
the tissue portion 610.
The connecting portion 142 here has a third cross-sectional area in a third
plane. The connecting
portion 142 is configured to connect the first portion 141' to the second
portion 141". Here, the
first portion 141' comprises a first wireless energy receiver 308a for
receiving energy transmitted
wirelessly by an external wireless energy transmitter, and an internal
wireless energy transmitter
308a configured to transmit energy wirelessly to the second portion.
Furthermore, the second
portion here comprises a second wireless energy receiver 308b configured to
receive energy
transmitted wirelessly by the internal wireless energy transmitter 308a.
Although receivers and transmitters may be discussed and illustrated
separately in the
present disclosure, it is to be understood that the receivers and/or
transmitters may be comprised in
a transceiver. Furthermore, the receivers and/or transmitters in the first
portion 141' and second
portion 141" respectively may form part of a single receiving or transmitting
unit configured for
receiving or transmitting energy and/or communication signals, including data.
Furthermore, the
internal wireless energy transmitter and/or a first wireless communication
receiver/transmitter may
be a separate unit 308c located in a lower portion of the first portion 141',
referred to as a proximal
end of the first portion 141' in other parts of the present disclosure, close
to the connecting portion
142 and the second portion 141". Such placement may provide for that energy
and/or
communication signals transmitted by the unit 308c will not be attenuated by
internal components
of the first portion 141' when being transmitted to the second portion 141".
Such internal
components may include a first energy storage unit 304a.
The first portion 141' here comprises a first energy storage unit 304a
connected to the first
wireless energy receiver 308a. The second portion comprises a second energy
storage unit 304b
connected to the second wireless energy receiver 308b. Such an energy storage
unit may be a solid-
state battery, such as a thionyl-chloride battery.
In some embodiments, the first wireless energy receiver 308a is configured to
receive
energy transmitted wirelessly by the external wireless energy transmitter and
store the received
energy in the first energy storage unit 304a. Furthermore, the internal
wireless energy transmitter
308a is configured to wirelessly transmit energy stored in the first energy
storage unit 304a to the
second wireless energy receiver 308b, and the second wireless energy receiver
308b is configured
to receive energy transmitted wirelessly by the internal wireless energy
transmitter 308a and store
the received energy in the second energy storage unit 305b.
The first energy storage unit 304a may be configured to store less energy than
the second
energy storage unit 304b, and/or configured to be charged faster than the
second energy storage
unit 304b. Hereby, charging of the first energy storage unit 304a may be
relatively quick, whereas
transfer of energy from the first energy storage unit 304a to the second
energy storage unit 304b
may be relatively slow. Thus, a user can quickly charge the first energy
storage unit 304a, and will
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not during such charging be restricted for a long period of time by being
connected to an external
wireless energy transmitter, e.g. at a particular location. After having
charged the first energy
storage unit 304a, the user may move freely while energy slowly transfers from
the first energy
storage unit 304a to the second energy storage unit 304b, via the first
wireless energy transmitter
308a,c and the second wireless energy receiver 308b.
The first portion may comprise a first controller comprising at least one
processing unit
306a. The second portion may comprise a second controller comprising at least
one processing unit
306b. At least one of the first and second processing unit 306a, 306b may be
connected to a
wireless transceiver 308a,b,c for communicating wirelessly with an external
device.
The first controller may be connected to a first wireless communication
receiver 308a,c in
the first portion 141' for receiving wireless communication from an external
device and/or from a
wireless communication transmitter 308b in the second portion 141".
Furthermore, the first
controller may be connected to a first wireless communication transmitter
308a,c in the first portion
141' for transmitting wireless communication to a second wireless
communication receiver 308b in
the second portion 141". The second controller may be connected to the second
wireless
communication receiver 308b for receiving wireless communication from the
first portion 141'.
The second controller may further be connected to a second wireless
communication transmitter
308b for transmitting wireless communication to the first portion 141'.
In some embodiments, the first wireless energy receiver 308a comprises a first
coil, and the
wireless energy transmitter 308a,c comprises a second coil, as shown in Fig.
45.
The device may further comprise at least one sensor (not shown) for providing
input to at
least one of the first and second controller. Such sensor data may be
transmitted to an external
device via the first wireless communication transmitter 308a and/or the second
wireless
communication transmitter 308b. The sensor may be or comprise a sensor
configured to sense a
physical parameter of the device 140. The sensor may also be or comprise a
sensor configured to
sense at least one of a temperature of the remote unit 140, a temperature of
an implantable device
for treating hypertension, a parameter related to the power consumption of the
device, a parameter
related to the power consumption of an implantable device for stimulating
tissue of the patient or
damping such a stimulation signal, a parameter related to a status of at least
one of the first and
second energy storage unit 304a, 304b, a parameter related to the wireless
transfer of energy from
a source external to the body of the patient, and a hydraulic pressure. The
sensor may also be or
comprise a sensor configured to sense a physiological parameter of the
patient, such as at least one
of a parameter related to the patient swallowing, a local temperature, a
systemic temperature, a
blood saturation, a blood oxygenation, a blood pressure, a parameter related
to an ischemia marker,
pH, pressure in the renal artery, or a vascular resistance in a blood vessel.
The sensor configured to
sense a parameter related to the patient swallowing may comprise at least one
of a motility sensor,
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a sonic sensor, an optical sensor, and a strain sensor. The sensor configured
to sense pH may be
configured to sense the acidity in the stomach.
The sensor may be configured to sense a temperature of the device 140, to
avoid excessive
heating of tissue connected to the device during operation of the device, or
during operation of an
external implant using the device, or charging of an energy storage unit in
the device 140.
Excessive heating may also damage the device and/or the energy storage unit.
Excessive heating
may also be an indicator that something is wrong with the device and may be
used for triggering an
alarm function for alerting the patient or physician. The sensor may also be
configured to sense a
parameter related to the power consumption of the device 140 or the power
consumption of an
external implant being powered by the device 140, to avoid excessive power
consumption which
may drain and/or damage the energy storage unit of the device 140. Excessive
power consumption
may also be an indicator that something is wrong with the device 140 and may
be used for
triggering an alarm function for alerting the patient or physician.
With reference to Figs. 35 and 38a-b, an embodiment of an implantable remote
unit 140
will be described. The remote unit 140 is configured to be held in position by
a tissue portion 610
of a patient. The remote unit 140 comprises a first portion 141' configured to
be placed on a first
side 612 of the tissue portion 610, the first portion 141' having a first
cross-sectional area Al in a
first plane P1 and comprising a first surface 614 configured to face and/or
engage a first tissue
surface 616 of the first side 612 of the tissue portion 610. The remote unit
140 further comprises a
second portion 141" configured to be placed on a second side 618 of the tissue
portion 610, the
second side 618 opposing the first side 612, the second portion 141" having a
second cross-
sectional area A2 in a second plane P2 and comprising a second surface 620
configured to engage a
second tissue surface 622 of the second side 618 of the tissue portion 610.
The remote unit 140
further comprises a connecting portion 142 configured to be placed through a
hole in the tissue
portion 610 extending between the first and second sides 612, 618 of the
tissue portion 610. The
connecting portion 142 here has a third cross-sectional area A3 in a third
plane P3. The connecting
portion 142 is configured to connect the first portion 141' to the second
portion 141". In the
illustrated embodiment, a connecting interface 630 between the connecting
portion 142 and the
second portion 141" is eccentric with respect to the second portion 141".
The first portion 141' has an elongated shape in the illustrated embodiment of
Fig. 35.
Similarly, the second portion 141" has an elongated shape. However, the first
portion 141' and/or
second portion 141" may assume other shapes, such as a flat disk e.g. having a
width and length
being larger than the height, a sphere, an ellipsoid, or any other polyhedral
or irregular shape, some
of these being exemplified in Figs. 35-37.
As illustrated in figs. 38a-b, the connecting interface 630 between the
connecting portion
142 and the second portion 141" may be eccentric, with respect to the second
portion 141" in a
first direction 631, but not in a second direction 633 being perpendicular to
the first direction. The
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first direction 631 is here parallel to the line A-A, to the second plane P2,
and to a length of the
second portion 141". The second direction 633 is here parallel to the line B-
B, to the second plane
P2, and to a width of the second portion 141". It is also possible that the
connecting interface
between the connecting portion 142 and the second portion 141" is eccentric,
with respect to the
second portion 141", in the first direction 631 as well as in the second
direction 633 being
perpendicular to the first direction 631.
Similarly, a connecting interface between the connecting portion 142 and the
first portion
141' may be eccentric with respect to the first portion 141' in the first
direction 631, and/or in the
second direction 633.
The first portion 141', connecting portion 142 and second portion 141" may
structurally
form one integral unit. It is however also possible that the first portion
141' and the connecting
portion 142 structurally form one integral unit, while the second portion 141"
form a separate unit,
or, that the second portion 141" and the connecting portion 142 structurally
form one integral unit,
while the first portion 141' form a separate unit.
Additionally, or alternatively, the second portion 141" may comprise a
removable and/or
interchangeable portion 639. In some embodiments, the removable portion 639
may form part of a
distal region which will be further described in other parts of the present
disclosure. A removable
portion may also form part of a proximal region. Thus, the second portion 141"
may comprise at
least two removable portions, each being arranged at a respective end of the
second portion 141".
The removable portion 639 may house, hold or comprise one or several
functional parts of the
remote unit 140, such as gears, motors, connections, reservoirs, and the like
as described in other
parts of the present disclosure. An embodiment having such removable portion
639 will be able to
be modified as necessary to circumstances of a particular patient.
In the case of the first portion 141', connecting portion 142 and second
portion 141"
structurally forming one integral unit, the eccentric connecting interface
between the connecting
portion 142 and the second portion 141", with respect to the second portion
141", will provide for
that the remote unit 140 will be able to be inserted into the hole in the
tissue portion. The remote
unit 140 may for example be inserted into the hole at an angle, similar to how
a foot is inserted into
a shoe, to allow most or all of the second portion 141" to pass through the
hole, before it is angled,
rotated, and/or pivoted to allow any remaining portion of the second portion
141" to pass through
the hole and allow the remote unit 140 to assume its intended position.
As illustrated in figs. 35-37, the first portion 141' may assume a variety of
shapes, such as
an oblong shape, a flat disk shape, a spherical shape, or any other polyhedral
or irregular shape.
Similarly, the second portion 141" may assume a variety of shapes, such as an
oblong shape, a flat
disk shape, a spherical shape, or any other polyhedral or irregular shape. The
proposed shapes of
the first and second portions 141', 141" may be mixed and combined to form
embodiments not
exemplified in the illustrated embodiments. For example, one or both of the
first and second
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portions 141', 141" may have a flat oblong shape. In this context, the term
"flat" is related to the
height of the first or second portion 141', 141", i.e. in a direction parallel
to a central extension Cl
of the connecting portion 142. The term "oblong" is related to a length of the
first or second portion
141', 141". A definition of such length is further discussed in other parts of
the present disclosure.
With reference to Figs. 38a-b, the second portion 141" has a first end 632 and
a second
end 634 opposing the first end 632. The length of the second portion 141" is
defined as the length
between the first end 632 and the second end 634. The length of the second
portion 141" is
furthermore extending in a direction being different to the central extension
Cl of the connecting
portion 142. The first end 632 and second end 634 are separated in a direction
parallel to the
second plane P2. Similarly, the first portion 141' has a length between a
first and a second end, the
length extending in a direction being different to the central extension Cl of
the connecting portion
142.
The second portion 141" may be curved along its length. For example, one or
both ends of
the second portion 141" may point in a direction being substantially different
from the second
plane P2, i.e. curving away from or towards the tissue portion when implanted.
In some
embodiments, the second portion 141" curves within the second plane P2,
exclusively or in
combination with curving in other planes. The second portion 141" may also be
curved in more
than one direction, i.e. along its length and along its width, the width
extending in a direction
perpendicular to the length.
The first and second ends 632, 634 of the second portion 141" may comprise an
elliptical
point respectively. For example, the first and second ends 632, 634 may
comprise a hemispherical
end cap respectively. It is to be understood that also the first and second
ends of the first portion
141' may have such features.
The second portion 141" may have at least one circular cross-section along the
length
between the first end 632 and second end 634, as illustrated in fig. 35. It is
however possible for the
second portion 141" to have at least one oval cross-section or at least one
elliptical cross-section
along the length between the first end 632 and the second end 634. Such cross-
sectional shapes
may also exist between ends in a width direction of the second portion 141".
Similarly, such cross-
sectional shapes may also exist between ends in a length and/or width
direction in the first portion
141'.
In the following paragraphs, some features and properties of the second
portion 141" will
be described. It is however to be understood that these features and
properties may also apply to the
first portion 141'.
The second portion 141" has a proximal region 636, an intermediate region 638,
and a
distal region 640. The proximal region 636 extends from the first end 632 to
an interface between
the connecting portion 142 and the second portion 141", the intermediate
region 638 is defined by
the connecting interface 630 between the connecting portion 142 and the second
portion 141", and
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the distal region 640 extends from the connecting interface 630 between the
connecting portion 142
and the second portion 141" to the second end 634. The proximal region 636 is
shorter than the
distal region 640 with respect to the length of the second portion, i.e. with
respect to the length
direction 631. Thus, a heel (the proximal region) and a toe (the distal
region) is present in the
second portion 141".
The second surface 620, configured to engage with the second tissue surface
622 of the
second side 618 of the tissue portion 610, is part of the proximal region 636
and the distal region
640. If a length of the second portion 141" is defined as x, and the width of
the second portion
141" is defined as y along respective length and width directions 631, 633
being perpendicular to
each other and substantially parallel to the second plane P2, the connecting
interface between the
connecting portion 142 and the second portion 141" is contained within a
region extending from
x>0 to x<x/2 and/or y>0 to y<y/2, x and y and 0 being respective end points of
the second portion
141" along said length and width directions. In other words, the connecting
interface between the
connecting portion 142 and the second portion 141" is eccentric in at least
one direction with
respect to the second portion 141", such that a heel and a toe is formed in
the second portion 141".
The first surface 614 configured to face and/or engage the first tissue
surface 616 of the
first side 612 of the tissue portion 610 may be substantially flat. In other
words, the first portion
141' may comprise a substantially flat side facing towards the tissue portion
610. Furthermore, an
opposing surface of the first portion 141', facing away from the tissue
portion 610, may be
substantially flat. Similarly, the second surface 620 configured to engage the
second tissue surface
622 of the second side 618 of the tissue portion 610 may be substantially
flat. In other words, the
second portion 141" may comprise a substantially flat side facing towards the
tissue portion 610.
Furthermore, an opposing surface of the second portion 141", facing away from
the tissue portion
610, may be substantially flat.
The second portion 141" may be tapered from the first end 632 to the second
end 634, thus
giving the second portion 141" different heights and/or widths along the
length of the second
portion 141". The second portion may also be tapered from each of the first
end 632 and second
end 634 towards the intermediate region 638 of the second portion 141".
Some dimensions of the first portion 141', the second portion 141" and the
connecting
portion 142 will now be disclosed. Any of the following disclosures of
numerical intervals may
include or exclude the end points of said intervals.
The first portion 141' may have a maximum dimension being in the range of 10
to 60 mm,
such as in the range of 10 to 40 mm such as in the range of 10 to 30 mm, such
as in the range of 10
to 25 mm, such as in the range of 15 to 40 mm, such as in the range of 15 to
35 mm, such as in the
range of 15 to 30 mm, such as in the range of 15 to 25 mm. By the term
"maximum dimension" it
is hereby meant the largest dimension in any direction.
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The first portion 141' may have a diameter being in the range of 10 to 60 mm,
such as in
the range of 10 to 40 mm such as in the range of 10 to 30 mm, such as in the
range of 10 to 25 mm,
such as in the range of 15 to 40 mm, such as in the range of 15 to 35 mm, such
as in the range of 15
to 30 mm, such as in the range of 15 to 25 mm.
The connecting portion 142 may have a maximum dimension in the third plane P3
in the
range of 2 to 20 mm, such as in the range of 2 to 15 mm, such as in the range
of 2 to 10 mm, such
as in the range of 5 to 10 mm, such as in the range of 8 to 20 mm, such as in
the range of 8 to 15
mm, such as in the range of 8 to 10 mm.
The second portion 141" may have a maximum dimension being in the range of 30
to 90
mm, such as in the range of 30 to 70 mm, such as in the range of 30 to 60 mm,
such as in the range
of 30 to 40 mm, such as in the range of 35 to 90 mm, such as in the range of
35 to 70 mm, such as
in the range of 35 to 60 mm, such as in the range of 35 to 40 mm.
The first portion has a first height H1, and the second portion has a second
height H2, both
heights being in a direction perpendicular to the first and second planes Pl,
P2. The first height
may be smaller than the second height. However, in the embodiments illustrated
in Figs. 38A-38B,
the first height H1 is substantially equal to the second height H2. Other
height ratios are possible,
for example the first height H1 may be less than 2/3 of the second height H2,
such as less than 1/2
of the second height H2, such as less than 1/3 of the second height H2, such
as less than 1/4 of the
second height H2, such as less than 1/5 of the second height H2, such as less
than 1/10 of the
second height H2.
As illustrated in Figs. 38a-b, the proximal region 636 has a length 642 being
shorter than a
length 646 of the distal region 640. The intermediate region 638 has a length
644, and a width 648.
In some embodiments, the length 644 of the intermediate region 638 is longer
than the width 648.
In other words, the connecting interface between the connecting portion 142
and the second portion
141" may be elongated, having a longer dimension (in the exemplified case, the
length) and a
shorter dimension (in the exemplified case, the width). It is also possible
that the length 644 of the
intermediate region 638 is shorter than the width 648 of the intermediate
region 638.
The length 646 of the distal region 640 is preferably longer than the length
644 of the
intermediate region 638, however, an equally long distal region 640 and
intermediate region 638,
or a shorter distal region 640 than the intermediate region 638, is also
possible. The length 642 of
the proximal region 636 may be shorter than, equal to, or longer than the
length 644 of the
intermediate region 638.
The length 644 of the intermediate region 638 is preferably less than half of
the length of
the second portion 141", i.e. less than half of the combined length of the
proximal region 636, the
intermediate region 638, and the distal region 630. In some embodiments, the
length 644 of the
intermediate region 638 is less than a third of the length of the second
portion 141", such as less
than a fourth, less than a fifth, or less than a tenth of the length of the
second portion 141".
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The connecting portion may have one of an oval cross-section, an elongated
cross-section,
and a circular cross-section, in a plane parallel to the third plane P3. In
particular, the connecting
portion may have several different cross-sectional shapes along its length in
the central extension
Cl.
In some embodiments the distal region 640 is configured to be directed
downwards in a
standing patient, i.e. in a caudal direction when the remote unit 140 is
implanted. As illustrated in
Figs. 39a-d, different orientations of the second portion 141" relative the
first portion 141' are
possible. In some embodiments, a connection between either the first portion
141' and the
connecting portion 142, or between the second portion 141" and the connecting
portion 142, may
allow for a plurality of different connecting orientations. For example, a
connection mechanism
between the first portion 141' and the connecting portion 142 (or between the
second portion 141"
and the connecting portion 142) may possess a 90 degree rotational symmetry to
allow the second
portion 141' to be set in four different positions with respect to the first
portion 141, each differing
from the other by 90 degrees. Other degrees of rotational symmetry are of
course possible, such as
30 degrees, 45 degrees, 60 degrees, 120 degrees, 180 degrees and so on. In
other embodiments
there are no connective mechanism between any of the first portion 141', the
connecting portion
142, and the second portion 141" (i.e. the portions are made as one integral
unit), and in such cases
different variants of the device 140 can be achieved during manufacturing. In
other embodiments,
the connective mechanism between the first portion 141' and the connecting
portion 142 (or
between the second portion 141" and the connecting portion 142) is non-
reversible, i.e. the first
portion 141' and the second portion 141" may initially be handled as separate
parts, but the
orientation of the second portion 141" relative the first portion 141' cannot
be changed once it has
been selected and the parts have been connected via the connecting portion
142.
The different orientations of the second portion 141" relative the first
portion 141' may be
.. defined as the length direction of the second portion 141" having a
relation or angle with respect to
a length direction of the first portion 141'. Such angle may be 15 degrees,
30, 45, 60, 75 90, 105,
120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270, 285, 300, 315, 330, 345
or 360 degrees. In
particular, the angle between the first portion 141' and the second portion
141" may be defined as
an angle in the planes P1 and P2, or as an angle in a plane parallel to the
tissue portion 610, when
the remote unit 140 is implanted. In the embodiment illustrated in Figs. 39a-
d, the length direction
of the second portion 141" is angled by 0, 90, 180, and 270 degrees with
respect to the length
direction of the first portion 141'.
The second end 634 of the second portion 141" may comprise one or several
connections
for connecting to an implant being located in a caudal direction from a
location of the implantable
energized medical device in the patient. Hereby, when the remote unit 140 is
implanted in a patient,
preferably with the distal region 640 and second end 634 pointing downwards in
a standing patient,
the connections will be closer to the implant as the second end 634 will be
pointing in the caudal
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direction whereas the first end 632 will be pointing in the cranial direction.
It is also possible that
the second end 634 of the second portion 141" is configured for connecting to
an implant, i.e. the
second end 634 may comprise a port, connector or other type of connective
element for
transmission of power, fluid, and/or signals.
Likewise, the first end 632 of the second portion 141" may comprise one or
several
connections for connecting to an implant being located in a cranial direction
from a location of the
implantable energized medical device in the patient. Hereby, when the remote
unit 140 is implanted
in a patient, preferably with the distal region 640 and second end 634
pointing downwards in a
standing patient, the connections will be closer to the implant as the first
end 632 will be pointing
in the cranial direction whereas the second end 634 will be pointing in the
caudal direction. It is
also possible that the first end 632 of the second portion 141" is configured
for connecting to an
implant, i.e. the first end 632 may comprise a port, connector or other type
of connective element
for transmission of power, fluid, and/or signals.
With reference to figs. 40 and 41, an embodiment of an implantable remote unit
140 will be
described. The remote unite 140 is configured to be held in position by a
tissue portion 610 of a
patient. The remote unit 140 comprises a first portion 141' configured to be
placed on a first side
612 of the tissue portion 610, the first portion 141' having a first cross-
sectional area in a first plane
and comprising a first surface 614 configured to face and/or engage a first
tissue surface 616 of the
first side 612 of the tissue portion 610. The remote unit 140 further
comprises a second portion
141" configured to be placed on a second side 618 of the tissue portion 610,
the second side 618
opposing the first side 612, the second portion 141" having a second cross-
sectional area in a
second plane and comprising a second surface 620 configured to engage a second
tissue surface
622 of the second side 618 of the tissue portion 610. The remote unit 140
further comprises a
connecting portion 142 configured to be placed through a hole in the tissue
portion 610 extending
.. between the first and second sides 612, 618 of the tissue portion 610. The
connecting portion 142
here has a third cross-sectional area in a third plane. The connecting portion
142 is configured to
connect the first portion 141' to the second portion 141".
With reference to Fig. 42, the first cross-sectional area has a first cross-
sectional distance
CD la and a second cross-sectional distance CD2a, the first and second cross-
sectional distances
CD la, CD2a being perpendicular to each other and the first cross-sectional
distance CD la being
longer than the second cross-sectional distance CD2a. Furthermore, the second
cross-sectional area
has a first cross-sectional distance CD lb and a second cross-sectional
distance CD2b, the first and
second cross-sectional distances CD2a, CD2b being perpendicular to each other
and the first cross-
sectional distance CD lb being longer than the second cross-sectional distance
CD2b. The first
.. cross-sectional distance CD la of the first cross-sectional area and the
first cross-sectional distance
CD lb of the second cross-sectional area are rotationally displaced in
relation to each other with an
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angle exceeding 45 to facilitate insertion of the second portion 141" through
the hole in the tissue
portion. In the embodiment illustrated in Fig. 42, the rotational displacement
is 90 .
The rotational displacement of the first portion 141' and the second portion
141" forms a
cross-like structure, being particularly advantageous in that insertion
through the hole in the tissue
portion 610 may be facilitated, and once positioned in the hole in the tissue
portion 610 a secure
position may be achieved. In particular, if the remote unit 140 is positioned
such that the second
portion 141" has its first cross-sectional distance CD lb extending along a
length extension of the
hole 611 in the tissue portion 610, insertion of the second potion 141"
through the hole 611 may be
facilitated. Furthermore, if the first portion 141' is then displaced in
relation to the second portion
141" such that the first cross-sectional distance CD la of the first portion
141' is displaced in
relation to a length extension of the hole 611, the first portion 141' may be
prevented from
travelling through the hole 611 in the tissue portion. In these cases, it is
particularly advantageous if
the hole 611 in the tissue portion is oblong, ellipsoidal, or at least has one
dimension in one
direction being longer than a dimension in another direction. Such oblong
holes in a tissue portion
may be formed for example in tissue having a fiber direction, where the
longest dimension of the
hole may be aligned with the fiber direction.
In the embodiment illustrated in Fig. 40, the first surface 614 of the first
portion 141' is
flat, thus providing a larger contact surface to the first tissue surface 616
and consequently less
pressure on the tissue portion. A more stable position may also be achieved by
the flat surface.
Also the second surface 620 of the second portion 141" may be flat. However,
other shapes, such
as those described in other parts of the present disclosure, are possible.
As shown in Fig. 42, the connecting portion 142 may have an elongated cross-
section in
the third plane. It may be particularly advantageous if the connecting portion
142 has a longer
length 644 than width 648, said length 644 extending in the same direction as
a length direction of
the second portion 141", i.e. in the same direction as an elongation of the
second portion 141".
Hereby, the elongation of the connecting portion 142 may run in the same
direction as an
elongation of the hole in the tissue portion.
With reference to Fig. 43, the rotational displacement of first cross-
sectional distance of the
first cross-sectional area and the first cross-sectional distance of the
second cross-sectional area is
shown, here at an angle about 45 . Accordingly, there is a rotational
displacement, in the first,
second and third planes, between a length direction 633 of the first portion
141' and a length
direction 631 of the second portion 141". Other angles of rotational
displacement are possible,
such as 60 , 75, 90 , 105 , 120 , 135 , etc.
One and the same remote unit 140 may be capable of assuming several different
arrangements with regards to rotational displacement of the first portion 141'
and the second
portion 141". In particular, this is possible when the first portion 141'
and/or the second portion
141" is configured to detachably connect to the interconnecting portion 142.
For example, a
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connection mechanism between the first portion 141' and the connecting portion
142, or between
the second portion 141" and the connecting portion 142, may possess a
rotational symmetry to
allow the first portion 141' to be set in different positions in relation to
the connecting portion 142
and in extension also in relation to the second portion 141". Likewise, such
rotational symmetry
may allow the second portion 142" to be set in different positions in relation
to the connecting
portion 142 and in extension also in relation to the first portion 141'.
With reference to Figs. 44a-c, a procedure of insertion of the remote unit 140
in a tissue
portion 610 will be described. The remote unit 140 may be oriented such that a
length direction 631
of the second portion 141" points downwards into the hole 611. Preferably, the
second portion
141" is positioned such that it is inserted close to an edge of the hole 611.
The second portion
141" may then be inserted partially through the hole 611, until the point
where the first portion
141' abuts the first tissue surface 616. Here, a 90 rotational displacement
between the first portion
141' and the second portion 141", as described above, will allow a relatively
large portion of the
second portion 141" to be inserted before the first portion 141' abuts the
first tissue surface 616.
Subsequently, the remote unit 140 may be pivoted to slide or insert the
remaining portion of the
second portion 141" through the hole 611. While inserting the remaining
portion of the second
portion 141", the tissue may naturally flex and move to give way for the
second portion 141".
Upon having fully inserted the second portion 141" through the hole 611, such
that the second
portion 141" is completely located on the other side of the tissue portion
610, the tissue may
naturally flex back.
With reference to fig. 45, an embodiment of an implantable remote unit 140,
which may be
referred to as a remote unit in other parts of the present disclosure, will be
described. The remote
unit 140 is configured to be held in position by a tissue portion 610 of a
patient. The remote unit
140 comprises a first portion 141' configured to be placed on a first side 612
of the tissue portion
610, the first portion 141' having a first cross-sectional area in a first
plane and comprising a first
surface 614 configured to face and/or engage a first tissue surface of the
first side 612 of the tissue
portion 610. The remote unit 140 further comprises a second portion 141"
configured to be placed
on a second side 618 of the tissue portion 610, the second side 618 opposing
the first side 612, the
second portion 141" having a second cross-sectional area in a second plane and
comprising a
.. second surface 620 configured to engage a second tissue surface of the
second side 618 of the
tissue portion 610. The remote unit 140 further comprises a connecting portion
142 configured to
be placed through a hole in the tissue portion 610 extending between the first
and second sides 612,
618 of the tissue portion 610. The connecting portion 142 here has a third
cross-sectional area in a
third plane. The connecting portion 142 is configured to connect the first
portion 141' to the second
portion 141".
At least one of the first portion and the second portion comprises at least
one coil
embedded in a ceramic material, the at least one coil being configured for at
least one of: receiving
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energy transmitted wirelessly, transmitting energy wirelessly, receiving
wireless communication,
and transmitting wireless communication. In the illustrated embodiment, the
first portion 141'
comprises a first coil 658 and a second coil 660, and the second portion 141"
comprises a third coil
662. The coils are embedded in a ceramic material 664
As discussed in other part of the present disclosure, the first portion 141'
may comprise a
first wireless energy receiver configured to receive energy transmitted
wirelessly from an external
wireless energy transmitter, and further the first portion 141' may comprise a
first wireless
communication receiver. The first wireless energy receiver and the first
wireless communication
receiver may comprise the first coil. Accordingly, the first coil may be
configured to receive energy
wirelessly, and/or to receive communication wirelessly.
By the expression "the receiver/transmitter comprising the coil" it is to be
understood that
said coil may form part of the receiver/transmitter.
The first portion 141' comprises a distal end 665 and a proximal end 666, here
defined with
respect to the connecting portion 142. In particular, the proximal end 665 is
arranged closer to the
connecting portion 142 and closer to the second portion 141" when the remote
unit 140 is
assembled. In the illustrated embodiment, the first coil 658 is arranged at
the distal end 665.
The first portion 141' may comprise an internal wireless energy transmitter,
and further a
first wireless communication transmitter. In some embodiments, the internal
wireless energy
transmitter and/or the first wireless communication transmitter comprises the
first coil 658.
However, in some embodiments the internal wireless energy transmitter and/or
the first wireless
communication transmitter comprises the second coil 660. The second coil 660
is here arranged at
the proximal end 665 of the first portion 141'. Such placement of the second
coil 660 may provide
for that energy and/or communication signals transmitted by the second coil
660 will not be
attenuated by internal components of the first portion 141' when being
transmitted to the second
portion 141".
In some embodiments, the first wireless energy receiver and the internal
wireless energy
transmitter comprises a single coil embedded in a ceramic material.
Accordingly, a single coil may
be configured for receiving energy wirelessly and for transmitting energy
wirelessly. Similarly, the
first wireless communication receiver and the first wireless communication
transmitter may
comprise a single coil embedded in a ceramic material. Even further, in some
embodiments a single
coil may be configured for receiving and transmitting energy wirelessly, and
for receiving and
transmitting communication signals wirelessly.
The coils discussed herein are preferably arranged in a plane extending
substantially
parallel to the tissue portion 610.
The second portion 141" may comprise a second wireless energy receiver, and/or
a second
wireless communication receiver. In some embodiments, the third coil 662 in
the second portion
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141" comprises the second wireless energy receiver and/or the second wireless
communication
receiver.
The second portion 141" comprises a distal end 668 and a proximal end 670,
here defined
with respect to the connecting portion 142. In particular, the proximal end
668 is arranged closer to
the connecting portion 142 and closer to the first portion 141' when the
remote unit 140 is
assembled. In the illustrated embodiment, the third coil 662 is arranged at
the proximal end 668 of
the second portion 141". Such placement of the third coil 662 may provide for
that energy and/or
communication signals received by the third coil 662 will not be attenuated by
internal components
of the second portion 141" when being received from the first portion 141'.
The first portion 141' may comprise a first controller 300a connected to the
first coil 658,
second coil 660, and/or third coil 662. The second portion 141" may comprise a
second controller
300b connected to the first coil, 658, second coil 660, and/or third coil 662.
In the illustrated embodiment ,the first portion 141' comprises a first energy
storage unit
304a connected to the first wireless energy receiver 308a, i.e. the first coil
658. The second portion
comprises a second energy storage unit 304b connected to the second wireless
energy receiver
308b, i.e. the third coil 662. Such an energy storage unit may be a solid-
state battery, such as a
thionyl-chloride battery.
In some embodiments, the first coil 658 is configured to receive energy
transmitted
wirelessly by the external wireless energy transmitter and store the received
energy in the first
energy storage unit 304a. Furthermore, the first coil 658 and/or the second
coil 660 may be
configured to wirelessly transmit energy stored in the first energy storage
unit 304a to the third coil
662, and the third coil 662 may be configured to receive energy transmitted
wirelessly by the first
coil 658 and/or the second coil 660 and store the received energy in the
second energy storage unit
305b.
The first energy storage unit 304a may be configured to store less energy than
the second
energy storage unit 304b, and/or configured to be charged faster than the
second energy storage
unit 304b. Hereby, charging of the first energy storage unit 304a may be
relatively quick, whereas
transfer of energy from the first energy storage unit 304a to the second
energy storage unit 304b
may be relatively slow. Thus, a user can quickly charge the first energy
storage unit 304a, and will
not during such charging be restricted for a long period of time by being
connected to an external
wireless energy transmitter, e.g. at a particular location. After having
charged the first energy
storage unit 304a, the user may move freely while energy slowly transfers from
the first energy
storage unit 304a to the second energy storage unit 304b, via the first and/or
second coil and the
third coil.
In the following, numbered aspect groups 3785E, 3795E1, 3795E2, 3805E, 3815E1,
3815E2, 3825E1, 3825E2, 3825E3, 4045E, 4055E, 4065E, 4075E, 4085E and 4095E of
the
present inventive concept are provided. The different aspects are numbered
individually within the
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groups and the references to other aspects relate primarily to aspects within
the same group. The
scope of protection is however defined by the appended claims.
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Aspect group 378 SE: SubcutaneousSontrol_Pop-Rivet2_Outside-Peritoneum
1. A method of implanting a powered medical device, the method comprising:
placing a first unit of a remote unit between a peritoneum and a layer of
muscular tissue of
the abdominal wall,
placing a second unit of the remote unit between the skin of the patient and a
layer of
muscular tissue of the abdominal wall, wherein the first and second units are
configured to be
connected by a connecting portion extending through at least one layer of
muscular tissue of the
abdominal wall,
placing a body engaging portion of the powered medical device in connection
with a tissue
or an organ of the patient which is to be affected by the powered medical
device, and
placing a transferring member, configured to transfer at least one of energy
and force from
the first unit to the body engaging portion, at least partially between a
peritoneum and a layer of
muscular tissue of the abdominal wall, such that at least 1/3 of the length of
the transferring
member is placed on the outside of the peritoneum.
2. The method according to any aspect 1, wherein the transferring member is
configured to
transfer electrical energy force from the first unit to the body engaging
portion.
3. The method according to aspect 1 or 2, wherein the transferring member
is configured to
transfer data between the first unit and the body engaging portion.
4. The method according to any one of the preceding aspects, wherein the
step of placing the
transferring member comprises placing the transferring member at least
partially between the
peritoneum and the layer of muscular tissue of the abdominal wall, such that
at least 1/2 of the
length of the transferring member is placed on the outside of the peritoneum
of the patient.
5. The method according to any one of the preceding aspects, wherein the
step of placing the
transferring member comprises placing the transferring member at least
partially between the
peritoneum and the layer of muscular tissue of the abdominal wall, such that
at least 2/3 of the
length of the transferring member is placed on the outside of the peritoneum
of the patient.
6. The method according to any one of the preceding aspects, wherein the
step of placing the
transferring member comprises placing the transferring member entirely outside
of the peritoneum
of the patient.
7. The method according to any one of the preceding aspects, wherein the
step of placing the
transferring member comprises placing the transferring member such that it
extends from the first
unit to an area between the rib cage and the peritoneum of the patient,
outside of the peritoneum.
8. The method according to any one of the preceding aspects, wherein the
step of placing the
transferring member comprises placing the transferring member such that it
extends from the first
unit to an area between the stomach and the thoracic diaphragm of the patient.
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9. The method according to any one of the preceding aspects, wherein the
step of placing the
transferring member comprises placing the transferring member such that it
extends from the first
unit to the retroperitoneal space.
10. The method according to aspect 9, wherein the step of placing the
transferring member
comprises placing the transferring member such that it extends from the first
unit to an area of the
kidneys.
11. The method according to aspect 10, wherein the step of placing the
transferring member
comprises placing the transferring member such that it extends from the first
unit to the renal
arteries.
12. The method according to any one of aspects 1 ¨ 5, wherein the step of
placing the
transferring member comprises placing the transferring member such that it
extends from the first
unit to the subperitoneal space, outside of the peritoneum.
13. The method according to any one of the preceding aspects, wherein the
step of placing the
first unit of the remote unit between the peritoneum and the layer of muscular
tissue of the
abdominal wall comprises placing the first unit between a first and second
layer of muscular tissue
of the abdominal wall.
14. The method according to any one of the preceding aspects, wherein the
step of placing the
first unit comprises placing a first unit comprising an energy storage unit.
15. The method according to any one of the preceding aspects, wherein the
step of placing the
first unit comprises placing a first unit comprising a receiver for receiving
at least one of: energy
and communication, wirelessly.
16. The method according to any one of the preceding aspects, wherein the
step of placing the
second unit comprises placing a second unit comprising a transmitter for
transmitting at least one
of: energy and communication, wirelessly.
17. The method according to any one of the preceding aspects, wherein the
step of placing the
first unit comprises placing a first unit comprising a controller involved in
the control of the
powered medical device.
18. The method according to any one of the preceding aspects, wherein the
first unit is
elongated and has a length axis extending substantially in the direction of
the elongation of the first
unit, and wherein the step of placing the first unit comprises placing the
first unit such that the
length axis is substantially parallel with the cranial-caudal axis of the
patient.
19. The method according to any one of aspects 1 ¨ 17, wherein the first
unit is elongated and
has a length axis extending substantially in the direction of the elongation
of the first unit, and
wherein the step of placing the first unit comprises placing the first unit
such that the length axis is
substantially perpendicular with the cranial-caudal axis of the patient.
20. The method according to any one of the preceding aspects, wherein the
first unit is
elongated and has a length axis extending substantially in the direction of
the elongation of the first
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unit, and wherein the step of placing the first unit comprises entering a hole
in a layer of muscular
tissue of the stomach wall in the direction of the length axis of the first
portion and pivoting or
angling the first portion after the hole has been entered.
21. The method according to any one of the preceding aspects, wherein the
step of placing the
second unit of the remote unit between the skin of the patient and a layer of
muscular tissue of the
abdominal wall comprises placing the second unit in the subcutaneous tissue.
22. The method according to any one of aspects 1 ¨ 20, wherein the step of
placing the second
unit of the remote unit between the skin of the patient and a layer of
muscular tissue of the
abdominal wall comprises placing the second unit between a first and second
layer of muscular
tissue of the abdominal wall.
23. The method according to any one of the preceding aspects, wherein the
step of placing the
second unit comprises placing a second unit comprising an energy storage unit.
24. The method according to any one of the preceding aspects, wherein the
step of placing the
second unit comprises placing a second unit comprising a receiver for
receiving at least one of:
energy and communication, wirelessly.
25. The method according to any one of the preceding aspects, wherein the
step of placing the
second unit comprises placing a second unit comprising a transmitter for
transmitting at least one
of: energy and communication, wirelessly.
26. The method according to any one of the preceding aspects, wherein the
step of placing the
second unit comprises placing a second unit comprising a controller involved
in the control of the
powered medical device.
27. The method according to any one of the preceding aspects, wherein the
second unit is
elongated and has a length axis extending substantially in the direction of
the elongation of the
second unit, and wherein the step of placing the second unit comprises placing
the second unit such
that the length axis is substantially parallel with the cranial-caudal axis of
the patient.
28. The method according to any one of the preceding aspects, wherein the
second unit is
elongated and has a length axis extending substantially in the direction of
the elongation of the
second unit, and wherein the step of placing the second unit comprises placing
the second unit such
that the length axis is substantially perpendicular with the cranial-caudal
axis of the patient.
29. The method according to any one of the preceding aspects, wherein the
first unit is
elongated and has a first unit length axis extending substantially in the
direction of the elongation
of the first unit second unit, and the second unit is elongated and has a
second unit length axis
extending substantially in the direction of the elongation of the second unit,
and wherein the step of
placing the first and second units comprises placing the first and second
units such that the first unit
length axis and the second unit length axis are places at an angle in relation
to each other exceeding
30 .
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30. The method according to aspect 29, wherein the step of placing the
first and second units
comprises placing the first and second units such that the first unit length
axis and the second unit
length axis are places at an angle in relation to each other exceeding 45 .
31. The method according to any one of the preceding aspects, further
comprising the step of
placing the connecting portion through at least one layer of muscular tissue
of the abdominal wall.
32. The method according to any one of the preceding aspects, wherein the
first unit, the
second unit and the connecting portion are portions of a single unit.
33. The method according to any one of aspects 1 ¨ 31, further comprising
the step of
connecting the first portion to the connecting portion, in situ.
34. The method according to any one of aspects 1 ¨ 31, further comprising
the step of
connecting the second portion to the connecting portion, in situ.
35. The method according to any one of the preceding aspects, further
comprising the step of
connecting the transferring member to the first unit.
36. The method according to any one of the preceding aspects, further
comprising the step of
connecting the transferring member to the body engaging portion.
37. The implantable device according to any of the preceding aspects,
wherein the body
engaging portion comprises an implantable constriction device.
38. The implantable device according to aspect 37, wherein the implantable
constriction device
comprises an implantable constriction device for constricting a blood vessel
of the patient.
39. The implantable device according to aspect 38, wherein the implantable
constriction device
for constricting a blood vessel of the patient is configured to constrict the
blood flow in the renal
artery to affect the patients systemic blood pressure.
40. The implantable device according to any one of the preceding
aspects, wherein the body
engaging element comprises an element for electrically stimulating a tissue
portion of a patient.
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Aspect group 379SE1: Hypertension_Local_Treatment2
1. A system for treating a patient with hypertension, comprising:
a stimulation device comprising an electrode arrangement configured to be able
to deliver
an electric stimulation signal to at least one of: a wall portion of a renal
artery and a
parasympathetic nerve innervating the renal artery of the patient, to affect a
vasomotor tone of a
smooth muscle tissue of the renal artery;
an implantable source of energy configured to energize the electrode
arrangement; and
a control unit operably connected to the stimulation device;
wherein the control unit is configured to control an operation of the
stimulation device such that the
electric stimulation signal causes a controlled vasodilation of the renal
artery.
2. The system according to aspect 1, wherein the electrode arrangement
comprises a plurality
of electrode elements, each of which being configured to engage and
electrically stimulate the wall
portion of the renal artery or the nerve innervating the renal artery.
3. The system according to aspect 1 or 2, wherein the electrode arrangement
is arranged on a
surface portion of a support structure, and wherein the surface portion is
configured to be placed on
the wall portion of the renal artery or on the nerve innervating the renal
artery.
4. The system according to aspect 3, wherein the support structure
comprises a cuff portion
configured to be arranged at least partly around the wall portion of the renal
artery or the nerve
innervating the renal artery.
5. The system according to aspect 4, wherein the electrode arrangement is
arranged on an
inner surface of the cuff
6. The system according to any of the preceding aspects, wherein the
electrode arrangement is
configured to electrically stimulate a sacral nerve.
7. The system according to any of the preceding aspects, wherein the
control unit is
configured to generate a pulsed electrical stimulation signal for affecting
the vasomotor tone of the
smooth muscle tissue of the renal artery.
8. The system according to aspect 7, wherein the electrical stimulation
signal comprises a
frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz.
9. The system according to aspect 7 or 8, wherein the electrical
stimulation signal comprises a
pulse width of 0.01-1 ms.
10. The system according to any of aspects 7 to 9, wherein the electrical
stimulation signal
comprises a pulse amplitude of 1-15 mA.
11. The system according to any of the preceding aspects, further
comprising a signal damping
device configured to be arranged at the parasympathetic nerve, at a position
between the
stimulation device and the spinal cord.
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12. The system according to aspect 11, wherein the signal damping device
comprises an
electrode arrangement configured to deliver an electric damping signal to the
parasympathetic
nerve, and wherein the electric damping signal is configured to at least
partly counteract the
electrical stimulation signal generated by the stimulation device.
13. The system according to aspect 12, wherein the signal damping device
further comprises a
signal processing means configured to measure the electrical stimulation
signal received at the
signal damping device and generate the electric damping signal based on the
received electrical
stimulation signal.
14. The system according to any of the preceding aspects, wherein the
control unit is
configured to be communicatively connected to a wireless remote control.
15. The system according to aspect 14, wherein the control unit comprises
an internal signal
transmitter configured to receive and transmit communication signals from/to
an external signal
transmitter.
16. The system according to any of the preceding aspects, further
comprising a blood pressure
sensor configured to generate a signal indicating a blood pressure of the
patient.
17. The system according to aspect 16, wherein the blood pressure sensor is
configured to
determine a local blood pressure in the renal artery.
18. The system according to aspect 16 or 17, wherein the blood pressure
sensor is configured
to determine a systemic blood pressure.
19. The system according to any of aspects 16-17, wherein the control unit
is configured to
receive the signal generated by the blood pressure sensor.
20. The system according to aspect 19, wherein the control unit is
configured to control the
operation of the stimulation device based on the received signal.
21. The system according to any of the preceding aspects, wherein the
source of energy is
configured to be implanted subcutaneously.
22. The system according to any of the preceding aspects, wherein the
source of energy
comprises at least one of a primary cell and a secondary cell.
23. The system according to any of the preceding aspects, wherein the
control unit is
configured to indicate a functional status of the source of energy.
24. The system according to aspect 23, wherein the functional status
indicates a charge level of
the source of energy.
25. The system according to any of aspects 1-22, wherein the control
unit is configured to
indicate a temperature of at least one of the source of energy, the wall
portion and the blood
flowing through the renal artery.
26. The system according to any of the preceding aspects, further
comprising a coating (760)
arranged on at least one surface of at least one of the stimulation device,
the implantable source of
energy, and the control unit.
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27. The system according to aspect 26, wherein the coating comprises at
least one layer of a
biomaterial.
28. The system according to aspect 27, wherein the biomaterial comprises at
least one drug or
substance with antithrombotic and/or antibacterial and/or antiplatelet
characteristics.
29. The system according to aspect 27 or 28, wherein the biomaterial is
fibrin-based.
30. The system according to any of aspects 27-29, further comprising a
second coating (760b)
arranged on the first coating.
31. The system according to aspect 30, wherein the second coating is a
different biomaterial
than said first coating.
32. The system according to aspect 31, wherein the first coating comprises
a layer of
perfluorocarbon chemically attached to the surface, and wherein the second
coating comprises a
liquid perfluorocarbon layer.
33. The system according to any one of aspects 27-32, wherein the
coating comprises a drug
encapsulated in a porous material.
34. The system according to any one of aspects 27-33, wherein the surface
comprises a metal.
35. The system according to aspect 34, wherein the metal comprises at least
one of titanium,
cobalt, nickel, copper, zinc, zirconium, molybdenum, tin and lead.
36. The system according to any of aspects 27-35, wherein the surface
comprises a
micropattern.
37. The system according to aspect 36, wherein the micropattern is etched
into the surface
prior to insertion into the body.
38. The system according to aspect 36 or 37, further comprising a layer of
a biomaterial coated
on the micropattern.
39. A communication system for enabling communication between a display
device and a
system (100) according to any of the preceding aspects, the communication
system comprising:
a display device,
a server, and
an external device,
wherein the display device comprises:
a wireless communication unit configured for wirelessly receiving an implant
control
interface from the server, the implant control interface being provided by the
external device, the
wireless communication unit further being configured for wirelessly
transmitting implant control
user input to the server, destined for the external device,
a display for displaying the received implant control interface, and
an input device for receiving implant control input from the user;
wherein the server comprises:
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a wireless communication unit configured for wirelessly receiving an implant
control
interface from the external device and wirelessly transmitting the implant
control interface to the
display device, the wireless communication unit further being configured for
wirelessly receiving
implant control user input from the display device and wirelessly transmitting
the implant control
user input to the external device, and
wherein the external device comprises:
a wireless communication unit configured for wireless transmission of control
commands
to the implantable device and configured for wireless communication with the
server, and
a computing unit configured for:
running a control software for creating the control commands for the operation
of the
implantable device,
transmitting a control interface to the server, destined for the display
device,
receiving implant control user input generated at the display device, from the
server, and
transforming the user input into the control commands for wireless
transmission to the
implantable device.
40. A system for treating a patient with hypertension according to any of
the preceding aspects,
wherein the stimulation device is adapted to stimulate the parasympathetic
system, thereby causing
vasodilation and lowering a blood pressure of the patient, wherein the
stimulation device is further
adapted to stimulate a parasympathetic nerve at least in a branch of a spinal
cord dispatching
number 10 and along the Coccygeal nerves originating at vertebrae S2-S4,
preferably S4.
41. A system according to any of the preceding aspects, wherein the
vasomotor tone of the wall
portion defines the flow in the renal artery and thereby indirect the blood
pressure.
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Aspect group 379SE2: Hypertension_Local_Treatment2
1. A system for treating a patient with hypertension, comprising:
a stimulation device comprising an electrode arrangement configured to be able
to deliver
an electric stimulation signal to the autonomic nerve system to directly or
indirectly control the
dilation, contraction, or contraction and dilation, of a wall portion of the
renal artery via a nerve
innervating the renal artery, to affect a vasomotor tone of the renal artery;
an implantable source of energy configured to energize the electrode
arrangement; and
a control unit operably connected to the stimulation device;
wherein the control unit is configured to control an operation of the
stimulation device such
that the electric stimulation signal causes at least one of vasodilation,
constriction, or alternating
between vasodilation and constriction, of the renal artery to control the
tonus in the wall of the
renal artery.
2. The system according to aspect 1, wherein the vasomotor tone of the wall
portion defines
the flow in the renal artery and thereby indirect the blood pressure.
3. The system according to aspect 2, wherein the parasympathetic nerve
comprises a branch
of spinal cord dispatching nerve number 10, and the Coccygeal nerves vertebrae
S2-S4, preferably
S4.
3. The system according to any of the preceding aspects, wherein the
electrode arrangement
comprises a plurality of electrode elements, each of which being configured to
engage and
electrically stimulate the wall portion of the renal artery or the nerve
innervating the renal artery.
4. The system according to any of the preceding aspects, wherein the
electrode arrangement is
arranged on a surface portion of a support structure, and wherein the surface
portion is configured
to be placed on the wall portion of the renal artery or on the nerve
innervating the renal artery.
5. The system according to aspect 4, wherein the support structure
comprises a cuff portion
configured to be arranged at least partly around the wall portion of the renal
artery or the nerve
innervating the renal artery.
6. The system according to aspect 5, wherein the electrode arrangement
is arranged on an
inner surface of the cuff
7. The system according to any of the preceding aspects, wherein the
electrode arrangement is
configured to electrically stimulate a sacral nerve.
8. The system according to any of the preceding aspects, wherein the
control unit is
configured to generate a pulsed electrical stimulation signal for affecting
the vasomotor tone of the
smooth muscle tissue of the renal artery.
9. The system according to aspect 8, wherein the electrical stimulation
signal comprises a
frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz.
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10. The system according to aspect 8 or 9, wherein the electrical
stimulation signal comprises a
pulse width of 0.01-1 ms.
11. The system according to any of aspects 8 to 10, wherein the electrical
stimulation signal
comprises a pulse amplitude of 1-15 mA.
12. The system according to any of the preceding aspects, further
comprising a signal damping
device configured to be arranged at the parasympathetic nerve, at a position
between the
stimulation device and the spinal cord.
13. The system according to aspect 12, wherein the signal damping device
comprises an
electrode arrangement configured to deliver an electric damping signal to the
parasympathetic
nerve, and wherein the electric damping signal is configured to at least
partly counteract the
electrical stimulation signal generated by the stimulation device.
14. The system according to aspect 13, wherein the signal damping device
further comprises a
signal processing means configured to measure the electrical stimulation
signal received at the
signal damping device and generate the electric damping signal based on the
received electrical
stimulation signal.
15. The system according to any of the preceding aspects, wherein the
control unit is
configured to be communicatively connected to a wireless remote control.
16. The system according to aspect 15, wherein the control unit comprises
an internal signal
transmitter configured to receive and transmit communication signals from/to
an external signal
transmitter.
17. The system according to any of the preceding aspects, further
comprising a blood pressure
sensor configured to generate a signal indicating a blood pressure of the
patient.
18. The system according to aspect 17, wherein the blood pressure sensor is
configured to
determine a local blood pressure in the renal artery.
19. The system according to aspect 17 or 18, wherein the blood pressure
sensor is configured
to determine a systemic blood pressure.
20. The system according to any of aspects 17-18, wherein the control unit
is configured to
receive the signal generated by the blood pressure sensor.
21. The system according to aspect 20, wherein the control unit is
configured to control the
operation of the stimulation device based on the received signal.
22. The system according to any of the preceding aspects, wherein the
source of energy is
configured to be implanted subcutaneously.
23. The system according to any of the preceding aspects, wherein the
source of energy
comprises at least one of a primary cell and a secondary cell.
24. The system according to any of the preceding aspects, wherein the
control unit is
configured to indicate a functional status of the source of energy.
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25. The system according to aspect 24, wherein the functional status
indicates a charge level of
the source of energy.
26. The system according to any of aspects 1-23, wherein the control unit
is configured to
indicate a temperature of at least one of the source of energy, the wall
portion and the blood
flowing through the renal artery.
27. The system according to any of the preceding aspects, further
comprising a coating
arranged on at least one surface of at least one of the stimulation device,
the implantable source of
energy, and the control unit.
28. The system according to aspect 27, wherein the coating comprises at
least one layer of a
biomaterial.
29. The system according to aspect 28, wherein the biomaterial comprises at
least one drug or
substance with antithrombotic and/or antibacterial and/or antiplatelet
characteristics.
30. The system according to aspect 28 or 29, wherein the biomaterial is
fibrin-based.
31. The system according to any of aspects 28-30, further comprising a
second coating
arranged on the first coating.
32. The system according to aspect 31, wherein the second coating is a
different biomaterial
than said first coating.
33. The system according to aspect 32, wherein the first coating comprises
a layer of
perfluorocarbon chemically attached to the surface, and wherein the second
coating comprises a
liquid perfluorocarbon layer.
34. The system according to any one of aspects 28-33 wherein the coating
comprises a drug
encapsulated in a porous material.
35. The system according to any one of aspects 28-34, wherein the surface
comprises a metal.
36. The system according to aspect 35, wherein the metal comprises at least
one of titanium,
cobalt, nickel, copper, zinc, zirconium, molybdenum, tin and lead.
37. The system according to any of aspects 28-36, wherein the surface
comprises a
micropattern.
38. The system according to aspect 37, wherein the micropattern is etched
into the surface
prior to insertion into the body.
39. The system according to aspect 37 or 38, further comprising a layer of
a biomaterial coated
on the micropattern.
40. A communication system for enabling communication between a display
device and a
system (100) according to any of the preceding aspects, the communication
system comprising:
a display device,
a server, and
an external device,
wherein the display device comprises:
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a wireless communication unit configured for wirelessly receiving an implant
control
interface from the server, the implant control interface being provided by the
external device, the
wireless communication unit further being configured for wirelessly
transmitting implant control
user input to the server, destined for the external device,
a display for displaying the received implant control interface, and
an input device for receiving implant control input from the user;
wherein the server comprises:
a wireless communication unit configured for wirelessly receiving an implant
control
interface from the external device and wirelessly transmitting the implant
control interface to the
1 0 display device, the wireless communication unit further being
configured for wirelessly receiving
implant control user input from the display device and wirelessly transmitting
the implant control
user input to the external device, and
wherein the external device comprises:
a wireless communication unit configured for wireless transmission of control
commands
1 5 to the implantable device and configured for wireless communication
with the server, and
a computing unit configured for:
running a control software for creating the control commands for the operation
of the
implantable device,
transmitting a control interface to the server, destined for the display
device,
20 receiving implant control user input generated at the display device,
from the server, and
transforming the user input into the control commands for wireless
transmission to the
implantable device.
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Aspect group 380SE: Hypertension_Local_Treatment_Holder
1 A medical device comprising:
an electrode arrangement configured to be able to deliver an electric
stimulation signal to at
least one of: a wall portion of a renal artery and a parasympathetic nerve
innervating the renal
artery of the patient, to affect a vasomotor tone of a smooth muscle tissue of
the renal artery;
a remote unit operably connected to the electrode arrangement and configured
to generate
the electric stimulation signal such that the electric stimulation signal
causes a controlled
vasodilation of the renal artery;
wherein the remote unit is configured to be secured to a tissue wall of the
patient;
wherein the remote unit comprises:
a first unit configured to be implanted at a first side of the tissue wall of
the patient;
a second unit configured to be implanted at a second side of the tissue wall;
and
a connecting unit configured to be arranged to extend through the tissue wall
and to be
mechanically attached to the first unit and the second unit;
wherein the first unit and the second unit are provided with a shape and size
hindering them
from passing through the tissue wall.
2. The device according to aspect 1, wherein the electrode arrangement
comprises a plurality
of electrode elements, each of which being configured to engage and
electrically stimulate the wall
portion of the renal artery or the nerve innervating the renal artery.
3. The device according to aspect 2, wherein the electrode arrangement is
arranged on a
surface portion of a support structure, and wherein the surface portion is
configured to be placed on
the wall portion of the renal artery or on the nerve innervating the renal
artery.
4. The device according to aspect 3, wherein the support structure
comprises a cuff portion
configured to be arranged at least partly around the wall portion of the renal
artery or the nerve
innervating the renal artery.
5. The device according to aspect 4, wherein the electrode arrangement is
arranged on an
inner surface of the cuff
6. The device according to any of the preceding aspects, wherein the
electrode arrangement is
configured to electrically stimulate a sacral nerve.
7. The device according to any of the preceding aspects, wherein the remote
unit is
configured to generate a pulsed electrical stimulation signal for affecting
the vasomotor tone of the
smooth muscle tissue of the renal artery.
8. The device according to aspect 7, wherein the electrical stimulation
signal comprises a
frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz.
9. The device according to aspect 7 or 8, wherein the electrical
stimulation signal comprises a
pulse width of 0.01-1 ms.
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10. The device according to any of aspects 7 to 9, wherein the electrical
stimulation signal
comprises a pulse amplitude of 1-15 mA.
11. The device according to any of the preceding aspects, further
comprising a signal damping
device configured to be arranged at the nerve innervating the renal artery, at
a position between the
electrode arrangement and the spinal cord.
12. The device according to aspect 11, wherein the signal damping device is
configured to
deliver an electric damping signal to the nerve, and wherein the electric
damping signal is
configured to at least partly counteract the electrical stimulation signal
delivered by the electrode
arrangement.
13. The device according to aspect 12, wherein the signal damping device
further comprises a
signal processing means configured to measure the electrical stimulation
signal received at the
signal damping device and generate the electric damping signal based on the
received electrical
stimulation signal.
14. The device according to any of the preceding aspects, wherein the
remote unit is
configured to be communicatively connected to a wireless control.
15. The system according to aspect 14, wherein the remote unit comprises an
internal signal
transmitter configured to receive and transmit communication signals from/to
an external signal
transmitter.
16. The system according to any of the preceding aspects, further
comprising a blood pressure
sensor configured to generate a signal indicating a blood pressure of the
patient.
17. The device according to aspect 16, wherein the blood pressure sensor is
configured to
determine a local blood pressure in the renal artery.
18. The device according to aspect 16 or 17, wherein the blood pressure
sensor is configured to
determine a systemic blood pressure.
19. The device according to any of aspects 16-17, wherein the remote unit
is configured to
receive the signal generated by the blood pressure sensor.
20. The device according to aspect 19, wherein the remote unit is
configured to generate the
electric stimulation signal based on the received signal.
21. The device according to any of the preceding aspects, further
comprising a source of
energy configured to energize the electrode arrangement.
22. The device according to aspect 21, wherein the source of energy is
arranged in the second
unit.
23. The device according to aspect 21, wherein the source of energy
configured to is
configured to be implanted subcutaneously.
24. The device according to any of aspects 21-23, wherein the source of
energy comprises at
least one of a primary cell and a secondary cell.
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25. The device according to any of aspects 21-24, wherein the remote unit
is configured to
indicate a functional status of the source of energy.
26. The device according to aspect 25, wherein the functional status
indicates a charge level of
the source of energy.
27. The device according to any of aspects 21-26, wherein the remote unit
is configured to
indicate a temperature of at least one of the source of energy, the wall
portion and the blood
flowing through the renal artery.
28. The device according to any of the preceding aspects, wherein:
the first unit has a first cross-sectional area in a first plane and comprises
a first surface
configured to engage a first tissue surface of the first side of the tissue
portion;
the second unit has a second cross-sectional area in a second plane and
comprises a second
surface configured to engage a second tissue surface of the second side of the
tissue portion;
the connecting unit has a third cross-sectional area in a third plane; and
the third cross-sectional area is smaller than the first and second cross-
sectional areas, such
that the first unit and the second unit are prevented from travelling through
the tissue wall.
29. The device according to any of the preceding aspects, wherein the
connecting unit has a
circular cross-section.
30. The device according to any of the preceding aspects, wherein the
connecting unit is
hollow.
31. The device according to any of the preceding aspects, wherein at least
one of the first and
second units is configured to be threaded onto the connecting unit.
32. The device according to any of the preceding aspects, wherein the first
and second unit
forms a bolted joint with the connecting unit.
33. The device according to any of the preceding aspects, wherein the
connecting unit is
elastic.
34. The device according to any of the preceding aspects, further
comprising a coating.
35. The device according to aspect 34, wherein the coating comprises
silicone.
36. The device according to any of aspects 11-13, wherein the signal
damping device is
arranged in at least one of the first unit, second unit and the connecting
unit.
37. The device according to any of aspects 16-20, wherein the sensor is
arranged in at least one
of the first unit, the second unit and the connecting unit.
38. The device according to any of aspects 21-27, wherein the source of
energy is arranged in
at least one of the first unit, the second unit and the connecting unit.
39. The device according to any of the preceding aspects, wherein at least
one of the first unit,
the second unit and the connecting unit comprises a wireless receiver
configured to receive energy
transmitted from outside the body of the patient.
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40. The device according to any of the preceding aspects, wherein at least
one of the first unit,
the second unit and the connecting unit comprises a wireless transceiver for
communicating
wirelessly with an external device.
41. The device according to any of the preceding aspects, wherein the
remote unit is
configured to be implanted in a tissue wall forming part of at least one of:
the diaphragm,
the left or right crus,
the medial or lateral arcuate ligament,
the psoas major,
the quadratus lumborum,
the transverse abdominal wall,
the psoas minor,
the internal oblique abdominal wall,
the iliacus, and
the psoas major.
42. The medical device according to any of the preceding aspects, further
comprising a coating
(760) arranged on at least one surface of at least one of the electrode
arrangement and the remote
unit.
43. The medical device according to aspect 42, wherein the coating
comprises at least one
layer of a biomaterial.
44. The medical device according to aspect 43, wherein the biomaterial
comprises at least one
drug or substance with antithrombotic and/or antibacterial and/or antiplatelet
characteristics.
45. The medical device according to aspect 43 or 44, wherein the
biomaterial is fibrin-based.
46. The medical device according to any of aspects 42-45, further
comprising a second coating
(760b) arranged on the first coating.
47. The medical device according to aspect 46, wherein the second coating
is a different
biomaterial than said first coating.
48. The medical device according to aspect 47, wherein the first coating
comprises a layer of
perfluorocarbon chemically attached to the surface, and wherein the second
coating comprises a
liquid perfluorocarbon layer.
49. The medical device according to any one of aspects 43-48, wherein the
coating comprises a
drug encapsulated in a porous material.
50. The medical device according to any one of aspects 43-49, wherein the
surface comprises a
metal.
51. The medical device according to aspect 50, wherein the metal comprises
at least one of
titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin and lead.
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52. The medical device according to any of aspects 43-51, wherein the
surface comprises a
micropattern.
53. The medical device according to aspect 52, wherein the micropattern is
etched into the
surface prior to insertion into the body.
54. The system according to aspect 52 or 53, further comprising a layer of
a biomaterial coated
on the micropattern.
55. A communication system for enabling communication between a display
device and a
medical device according to any of the preceding aspects, the communication
system comprising:
a display device,
a server, and
an external device,
wherein the display device comprises:
a wireless communication unit configured for wirelessly receiving an implant
control
interface from the server, the implant control interface being provided by the
external device, the
wireless communication unit further being configured for wirelessly
transmitting implant control
user input to the server, destined for the external device,
a display for displaying the received implant control interface, and
an input device for receiving implant control input from the user;
wherein the server comprises:
a wireless communication unit configured for wirelessly receiving an implant
control
interface from the external device and wirelessly transmitting the implant
control interface to the
display device, the wireless communication unit further being configured for
wirelessly receiving
implant control user input from the display device and wirelessly transmitting
the implant control
user input to the external device, and
wherein the external device comprises:
a wireless communication unit configured for wireless transmission of control
commands
to the medical device and configured for wireless communication with the
server, and
a computing unit configured for:
running a control software for creating the control commands for the operation
of the
medical device,
transmitting a control interface to the server, destined for the display
device,
receiving implant control user input generated at the display device, from the
server, and
transforming the user input into the control commands for wireless
transmission to the
medical device.
56. A medical device according to any of the preceding aspects, wherein the
vasomotor tone is
affected by smooth muscle tissue of the wall of the renal artery.
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Aspect group 381SE1: Hypertension Local Treatment Automatic
1. A system for treating a patient suffering from hypertension,
comprising:
a stimulation device comprising an electrode arrangement configured to be able
to deliver
an electric stimulation signal to at least one of: a wall portion of a renal
artery and a
parasympathetic nerve innervating the renal artery of the patient, to affect a
vasomotor tone of a
smooth muscle tissue of the renal artery;
an implantable sensor configured to generate a signal indicative of a blood
pressure of the
patient; and
a control unit communicatively connected to the stimulation device and to the
sensor
device;
wherein the control unit is configured to control an operation of the
stimulation device, based on
the signal generated by the sensor device, such that the electric stimulation
signal causes a
controlled vasodilation of the renal artery.
2. The system according to aspect 1, wherein the sensor comprises a
pressure sensor
configured to be arranged in a blood vessel of the patient.
3. The system according to aspect 1, wherein the sensor is configured to be
arranged at an
outer wall of a blood vessel of the patient.
4. The system according to aspect 3, wherein the sensor is configured to
measure a pressure
pulse wave transmitted from the blood flow to the outer wall of the blood
vessel.
5. The system according to aspect 4, wherein the sensor comprises a strain
gauge sensitive to
strain in the outer wall of the blood vessel.
6. The system according to aspect 4 or 5, wherein the sensor comprises a
contact pressure
sensor sensitive to a pressing force between the outer wall of the blood
vessel and the pressure
sensor.
7. The system according to aspect 3, wherein the sensor comprises a doppler
radar sensor
configured to measure the blood pressure in the blood vessel.
8. The system according to aspect 1, wherein the sensor comprises a light
source and a light
sensor, and wherein the signal is based on a light coupling efficiency between
the light source and
.. the light sensor.
9. The system according to aspect 1, wherein the sensor is configured to
generate a signal
indicative of a vascular resistance in a portion of the circulatory system of
the patient.
10. The system according to aspect 9, wherein the sensor is a flow sensor
configured to
generate a signal indicative of a flow through a blood vessel.
11. The system according to any of the preceding aspects, wherein the
control unit is
configured to:
determine an estimated blood pressure based the on signal generated by the
sensor;
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wherein the determined blood pressure is a local blood pressure in the renal
artery or a
systemic blood pressure.
12. The system according to aspect 11, wherein the control unit is
configured to:
compare the estimated blood pressure with a predetermined limit value; and
in response to the estimated blood pressure being below the limit value,
control the
operation of the stimulation device to cause vasoconstriction of the renal
artery; and
in response to the estimated blood pressure exceeding the limit value, control
the operation
of the stimulation device to cause vasodilation of the renal artery.
13. The system according to aspect 11, wherein the control unit is
configured to:
monitor, over time, the estimated blood pressure based on the signal generated
by the
sensor; and
in response to the estimated blood pressure sinking over time, control the
operation of the
stimulation device to cause vasoconstriction of the renal artery; and
in response to the estimated blood pressure rising over time, control the
operation of the
stimulation device to cause vasodilation of the renal artery.
14. The system according to any of the preceding aspects, wherein the
control unit comprises
an internal signal transmitter configured to receive and transmit
communication signals from/to an
external signal transmitter.
15. The system according to any of the preceding aspects, wherein the
electrode arrangement
comprises a plurality of electrode elements, each of which being configured to
engage and
electrically stimulate the wall portion of the renal artery or the nerve
innervating the renal artery.
16. The system according to any of the preceding aspects, wherein the
electrode arrangement is
arranged on a surface portion of a support structure, and wherein the surface
portion is configured
to be placed on the wall portion of the renal artery or on the nerve
innervating the renal artery.
17. The system according to aspect 16, wherein the support structure
comprises a cuff portion
configured to be arranged at least partly around the wall portion of the renal
artery or the nerve
innervating the renal artery.
18. The system according to aspect 17, wherein the electrode arrangement
is arranged on an
inner surface of the cuff
19. The system according to any of the preceding aspects, wherein the
electrode arrangement is
configured to electrically stimulate a sacral nerve.
20. The system according to any of the preceding aspects, wherein the
control unit is
configured to generate a pulsed electrical stimulation signal for affecting
the vasomotor tone of the
smooth muscle tissue of the renal artery.
21. The system according to aspect 20, wherein the electrical stimulation
signal comprises a
frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz.
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22. The system according to aspect 20 or 21, wherein the electrical
stimulation signal
comprises a pulse width of 0.01-1 ms.
23. The system according to any of aspects 20 to 22, wherein the electrical
stimulation signal
comprises a pulse amplitude of 1-15 mA.
24. The system according to any of the preceding aspects, further
comprising a signal damping
device configured to be arranged at the nerve innervating the renal artery, at
a position between the
stimulation device and the spinal cord.
25. The system according to aspect 24, wherein the signal damping device
comprises an
electrode arrangement configured to deliver an electric damping signal to the
nerve, and wherein
the electric damping signal is configured to at least partly counteract the
electrical stimulation
signal generated by the stimulation device.
26. The system according to aspect 25, wherein the signal damping device
further comprises a
signal processing means configured to measure the electrical stimulation
signal received at the
signal damping device and generate the electric damping signal based on the
received electrical
stimulation signal.
27. The system according to aspect 24, wherein the signal damping device is
configured to
deliver an electric scrambling signal for disturbing the electrical
stimulation signal passing the
signal damping device.
28. The system according to any of the preceding aspects, further
comprising a source of
energy configured to energize at least one of the stimulation device, the
sensor, and the control
unit.
29. The system according to aspect 28, wherein the source of energy is
arranged in the control
unit.
30. The system according to aspect 28, wherein the source of energy is
configured to be
implanted subcutaneously.
31. The system according to any of aspects 28-30, wherein the source of
energy comprises at
least one of a primary cell and a secondary cell.
32. The system according to any of aspects 28-31, wherein the control unit
is configured to
indicate a functional status of the source of energy.
33. The system according to aspect 32, wherein the functional status
indicates a charge level of
the source of energy.
34. The system according to any of aspects 28-33, wherein the control
unit is configured to
indicate a temperature of at least one of the source of energy, the wall
portion and the blood
flowing through the renal artery.
35. The system according to any of the preceding aspects, further
comprising a coating (760)
arranged on at least one surface of at least one of the stimulation device,
the sensor, and the control
unit.
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36. The system according to aspect 35, wherein the coating comprises at
least one layer of a
biomaterial.
37. The system according to aspect 36, wherein the biomaterial comprises at
least one drug or
substance with antithrombotic and/or antibacterial and/or antiplatelet
characteristics.
38. The system according to aspect 36 or 37, wherein the biomaterial is
fibrin-based.
39. The system according to any of aspects 36-39, further comprising a
second coating (760b)
arranged on the first coating.
40. The system according to aspect 39, wherein the second coating is a
different biomaterial
than said first coating.
41. The system according to aspect 40, wherein the first coating comprises
a layer of
perfluorocarbon chemically attached to the surface, and wherein the second
coating comprises a
liquid perfluorocarbon layer.
42. The system according to any one of aspects 36-41, wherein the
coating comprises a drug
encapsulated in a porous material.
43. The system according to any one of aspects 36-42, wherein the surface
comprises a metal.
44. The system according to aspect 43, wherein the metal comprises at least
one of titanium,
cobalt, nickel, copper, zinc, zirconium, molybdenum, tin and lead.
45. The system according to any of aspects 36-44, wherein the surface
comprises a
micropattern.
46. The system according to aspect 45, wherein the micropattern is etched
into the surface
prior to insertion into the body.
51. The system according toc alim 45 or 46, further comprising a layer of a
biomaterial coated
on the micropattern.
52. A communication system for enabling communication between a display
device and a
system according to any of the preceding aspects, the communication system
comprising:
a display device,
a server, and
an external device,
wherein the display device comprises:
a wireless communication unit configured for wirelessly receiving an implant
control
interface from the server, the implant control interface being provided by the
external device, the
wireless communication unit further being configured for wirelessly
transmitting implant control
user input to the server, destined for the external device,
a display for displaying the received implant control interface, and
an input device for receiving implant control input from the user;
wherein the server comprises:
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a wireless communication unit configured for wirelessly receiving an implant
control
interface from the external device and wirelessly transmitting the implant
control interface to the
display device, the wireless communication unit further being configured for
wirelessly receiving
implant control user input from the display device and wirelessly transmitting
the implant control
user input to the external device, and
wherein the external device comprises:
a wireless communication unit configured for wireless transmission of control
commands
to the system and configured for wireless communication with the server, and
a computing unit configured for:
1 0 running a control software for creating the control commands for the
operation of the
system,
transmitting a control interface to the server, destined for the display
device,
receiving implant control user input generated at the display device, from the
server, and
transforming the user input into the control commands for wireless
transmission to the
1 5 system.
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Aspect group 381SE2: Hypertension_Local_Treatment_Automatic
1. A system for treating a patient suffering from hypertension, comprising:
a stimulation device comprising an electrode arrangement configured to be able
to deliver
an electric stimulation signal to a parasympathetic nerve affecting a wall
portion of a renal artery of
the patient to dilate the renal artery, wherein the parasympathetic nerve
comprises at least one of a
parasympathetic nerve from at least a branch of spinal cord dispatching nerve
number 10 and the
Coccygeal nerves originating from vertebrae S2-S4, preferably S4;
an implantable sensor configured to generate a signal indicative of a blood
pressure of the
patient; and
a control unit communicatively connected to the stimulation device and to the
sensor
device;
wherein the control unit is configured to control an operation of the
stimulation device,
based on the signal generated by the sensor device, such that the electric
stimulation signal causes a
controlled vasodilation of the renal artery affecting the blood pressure
regulating of the kidney,
causing the general blood pressure to be lowered and thereby indirect control
the hypertonia of the
patient.
2. The system according to aspect 1, wherein the sensor comprises a
pressure sensor
configured to be arranged in a blood vessel of the patient.
3. The system according to aspect 1, wherein the sensor is configured to be
arranged at an
outer wall of a blood vessel of the patient.
4. The system according to aspect 3, wherein the sensor is configured to
measure a pressure
pulse wave transmitted from the blood flow to the outer wall of the blood
vessel.
5. The system according to aspect 4, wherein the sensor comprises a strain
gauge sensitive to
strain in the outer wall of the blood vessel.
6. The system according to aspect 4 or 5, wherein the sensor comprises a
contact pressure
sensor sensitive to a pressing force between the outer wall of the blood
vessel and the pressure
sensor.
7. The system according to aspect 3, wherein the sensor comprises a doppler
radar sensor
configured to measure the blood pressure in the blood vessel.
8. The system according to aspect 1, wherein the sensor comprises a light
source and a light
sensor, and wherein the signal is based on a light coupling efficiency between
the light source and
the light sensor.
9. The system according to aspect 1, wherein the sensor is configured to
generate a signal
indicative of a vascular resistance in a portion of the circulatory system of
the patient.
10. The system according to aspect 9, wherein the sensor is a flow sensor
configured to
generate a signal indicative of a flow through a blood vessel.
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11. The system according to any of the preceding aspects, wherein the
control unit is
configured to:
determine an estimated blood pressure based the on signal generated by the
sensor;
wherein the determined blood pressure is a local blood pressure in the renal
artery or a
systemic blood pressure.
12. The system according to aspect 11, wherein the control unit is
configured to:
compare the estimated blood pressure with a predetermined limit value; and
in response to the estimated blood pressure being below the limit value,
control the
operation of the stimulation device to cause vasoconstriction of the renal
artery; and
in response to the estimated blood pressure exceeding the limit value, control
the operation
of the stimulation device to cause vasodilation of the renal artery.
13. The system according to aspect 11, wherein the control unit is
configured to:
monitor, over time, the estimated blood pressure based on the signal generated
by the
sensor; and
1 5 in response to the estimated blood pressure sinking over time, control
the operation of the
stimulation device to cause vasoconstriction of the renal artery; and
in response to the estimated blood pressure rising over time, control the
operation of the
stimulation device to cause vasodilation of the renal artery.
14. The system according to any of the preceding aspects, wherein the
control unit comprises
an internal signal transmitter configured to receive and transmit
communication signals from/to an
external signal transmitter.
15. The system according to any of the preceding aspects, wherein the
electrode arrangement
comprises a plurality of electrode elements, each of which being configured to
engage and
electrically stimulate the wall portion of the renal artery or the nerve
innervating the renal artery.
16. The system according to any of the preceding aspects, wherein the
electrode arrangement is
arranged on a surface portion of a support structure, and wherein the surface
portion is configured
to be placed on the wall portion of the renal artery or on the nerve
innervating the renal artery.
17. The system according to aspect 16, wherein the support structure
comprises a cuff portion
configured to be arranged at least partly around the wall portion of the renal
artery or the nerve
innervating the renal artery.
18. The system according to aspect 17, wherein the electrode arrangement is
arranged on an
inner surface of the cuff
19. The system according to any of the preceding aspects, wherein the
electrode arrangement is
configured to electrically stimulate a sacral nerve.
20. The system according to any of the preceding aspects, wherein the
control unit is
configured to generate a pulsed electrical stimulation signal for affecting
the vasomotor tone of the
smooth muscle tissue of the renal artery.
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21. The system according to aspect 20, wherein the electrical stimulation
signal comprises a
frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz.
22. The system according to aspect 20 or 21, wherein the electrical
stimulation signal
comprises a pulse width of 0.01-1 ms.
23. The system according to any of aspects 20 to 22, wherein the electrical
stimulation signal
comprises a pulse amplitude of 1-15 mA.
24. The system according to any of the preceding aspects, further
comprising a signal damping
device configured to be arranged at the nerve innervating the renal artery, at
a position between the
stimulation device and the spinal cord.
25. The system according to aspect 24, wherein the signal damping device
comprises an
electrode arrangement configured to deliver an electric damping signal to the
nerve, and wherein
the electric damping signal is configured to at least partly counteract the
electrical stimulation
signal generated by the stimulation device.
26. The system according to aspect 25, wherein the signal damping device
further comprises a
signal processing means configured to measure the electrical stimulation
signal received at the
signal damping device and generate the electric damping signal based on the
received electrical
stimulation signal.
27. The system according to aspect 24, wherein the signal damping device is
configured to
deliver an electric scrambling signal for disturbing the electrical
stimulation signal passing the
signal damping device.
28. The system according to any of the preceding aspects, further
comprising a source of
energy configured to energize at least one of the stimulation device, the
sensor, and the control
unit.
29. The system according to aspect 28, wherein the source of energy is
arranged in the control
unit.
30. The system according to aspect 28, wherein the source of energy is
configured to be
implanted subcutaneously.
31. The system according to any of aspects 28-30, wherein the source of
energy comprises at
least one of a primary cell and a secondary cell.
32. The system according to any of aspects 28-31, wherein the control unit
is configured to
indicate a functional status of the source of energy.
33. The system according to aspect 32, wherein the functional status
indicates a charge level of
the source of energy.
34. The system according to any of aspects 28-33, wherein the control unit
is configured to
indicate a temperature of at least one of the source of energy, the wall
portion and the blood
flowing through the renal artery.
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35. The system according to any of the preceding aspects, further
comprising a coating (760)
arranged on at least one surface of at least one of the stimulation device,
the sensor, and the control
unit.
36. The system according to aspect 35, wherein the coating comprises at
least one layer of a
biomaterial.
37. The system according to aspect 36, wherein the biomaterial comprises at
least one drug or
substance with antithrombotic and/or antibacterial and/or antiplatelet
characteristics.
38. The system according to aspect 36 or 37, wherein the biomaterial is
fibrin-based.
39. The system according to any of aspects 36-39, further comprising a
second coating (760b)
arranged on the first coating.
40. The system according to aspect 39, wherein the second coating is a
different biomaterial
than said first coating.
41. The system according to aspect 40, wherein the first coating comprises
a layer of
perfluorocarbon chemically attached to the surface, and wherein the second
coating comprises a
liquid perfluorocarbon layer.
42. The system according to any one of aspects 36-41, wherein the coating
comprises a drug
encapsulated in a porous material.
43. The system according to any one of aspects 36-42, wherein the surface
comprises a metal.
44. The system according to aspect 43, wherein the metal comprises at least
one of titanium,
cobalt, nickel, copper, zinc, zirconium, molybdenum, tin and lead.
45. The system according to any of aspects 36-44, wherein the surface
comprises a
micropattern.
46. The system according to aspect 45, wherein the micropattern is etched
into the surface
prior to insertion into the body.
51. The system according toc alim 45 or 46, further comprising a layer of a
biomaterial coated
on the micropattern.
52. A communication system for enabling communication between a display
device and a
system according to any of the preceding aspects, the communication system
comprising:
a display device,
a server, and
an external device,
wherein the display device comprises:
a wireless communication unit configured for wirelessly receiving an implant
control
interface from the server, the implant control interface being provided by the
external device, the
wireless communication unit further being configured for wirelessly
transmitting implant control
user input to the server, destined for the external device,
a display for displaying the received implant control interface, and
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an input device for receiving implant control input from the user;
wherein the server comprises:
a wireless communication unit configured for wirelessly receiving an implant
control
interface from the external device and wirelessly transmitting the implant
control interface to the
display device, the wireless communication unit further being configured for
wirelessly receiving
implant control user input from the display device and wirelessly transmitting
the implant control
user input to the external device, and
wherein the external device comprises:
a wireless communication unit configured for wireless transmission of control
commands
1 0 to the system and configured for wireless communication with the
server, and
a computing unit configured for:
running a control software for creating the control commands for the operation
of the
system,
transmitting a control interface to the server, destined for the display
device,
1 5 receiving implant control user input generated at the display device,
from the server, and
transforming the user input into the control commands for wireless
transmission to the system.
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Aspect group 382SE1: Hypertension Local Treatment Cancellation
1. A system for treating a patient with hypertension, comprising:
a stimulation device comprising a first electrode arrangement configured to be
able to
deliver an electric stimulation signal to at least one of: a wall portion of a
renal artery and a
parasympathetic nerve innervating the renal artery of the patient, to affect a
vasomotor tone of the
renal artery;
a signal damping device comprising a second electrode arrangement configured
to deliver
an electric damping signal to tissue of the patient;
1 0 a control unit operably connected to the stimulation device and to the
signal damping
device, wherein the control unit is configured to control an operation of the
stimulation device such
that the electric stimulation signal causes a controlled vasodilation of the
renal artery, and to
control an operation of the signal damping device to damp or disturb the
electric stimulation signal
delivered by the stimulation device, thereby reducing at least one of a
backward and a forward
propagation of the electric stimulation.
2. The system according to aspect 1, wherein the second electrode
arrangement is configured
to deliver the electric damping signal to the nerve innervating the renal
artery to damp or reduce
transmission of the electric stimulation signal in the nerve.
3. The system according to aspect 2, wherein the second electrode
arrangement is configured
to deliver the electric damping signal at a position between the first
electrode arrangement and a
spinal cord of the patient.
4. The system according to aspect 1, wherein at least one of the first and
second electrode
arrangements comprises a plurality of electrode elements, each of which being
configured to
engage and electrically stimulate the wall portion of the renal artery or the
nerve innervating the
renal artery.
5. The system according to aspect 1, wherein at least one of the first and
second electrode
arrangements is arranged on a surface portion of a support structure, and
wherein the surface
portion is configured to be placed on the wall portion of the renal artery or
on the nerve innervating
the renal artery.
6. The system according to aspect 5, wherein the support structure
comprises a cuff
configured to be arranged at least partly around the wall portion of the renal
artery or the nerve
innervating the renal artery.
7. The system according to aspect 6, wherein at least one of the first
and second electrode
arrangements is arranged on an inner surface of the cuff
8. The system according to any of the preceding aspects, wherein each of
the stimulation
device and the signal damping device is configured to deliver an electric
stimulation signal and an
electric damping signal, respectively, to a parasympathetic nerve.
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9. The system according to any of the preceding aspects, wherein the
control unit is
configured to generate a pulsed electric stimulation signal for affecting the
vasomotor tone of the
smooth muscle tissue of the renal artery.
10. The system according to aspect 9, wherein the electric stimulation
signal comprises a
frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz.
11. The system according to aspect 9 or 10, wherein the electric
stimulation signal comprises a
pulse width of 0.01-1 ms.
12. The system according to any of aspects 9 to 11, wherein the electric
stimulation signal
comprises a pulse amplitude of 1-15 mA.
13. The system according to any of the preceding aspects, wherein the
control unit if
configured to generate the electric damping signal based on the electric
stimulation signal.
14. The system according to aspect 13, wherein the electric damping signal
is out of phase with
the electric stimulation signal.
15. The system according to aspect 13, wherein the electric stimulation
signal and the electric
damping signal are pulsed signals, and wherein a frequency of the electric
damping signal is higher
than a frequency of the electric stimulation signal.
16. The system according to aspect 15, wherein the frequency of the
electric damping signal is
at least twice the frequency of the electric stimulation signal.
17. The system according to aspect 13, wherein the signal damping device is
configured to
deliver an electric scrambling signal for disturbing the electric stimulation
signal passing the signal
damping device.
18. The system according to any of the preceding aspects, further
comprising a signal
processing means configured to measure the electric stimulation signal
received at the signal
damping device and to generate the electric damping signal based on the
received electric
stimulation signal.
19. The system according to any of the preceding aspects, wherein the
control unit is
configured to be communicatively connected to a wireless remote control.
20. The system according to aspect 19, wherein the control unit comprises
an internal signal
transmitter configured to receive and transmit communication signals from/to
an external signal
transmitter.
21. The system according to any of the preceding aspects, further
comprising a source of
energy for energising the first and second electrode arrangements.
22. The system according to aspect 21, wherein the source of energy is
configured to be
implanted subcutaneously.
23. The system according to aspect 21 or 22, wherein the source of energy
comprises at least
one of a primary cell and a secondary cell.
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24. The system according to any of aspects 21 to 23, wherein the control
unit is configured to
indicate a functional status of the source of energy.
25. The system according to aspect 24, wherein the functional status
indicates a charge level of
the source of energy.
26. The system according to any of aspects 21-25, wherein the control unit
is configured to
indicate a temperature of at least one of the source of energy, the nerve and
tissue adjacent to the
nerve.
27. The system according to any of the preceding aspects, further
comprising a blood pressure
sensor configured to generate a signal indicating a blood pressure of the
patient.
28. The system according to aspect 27, wherein the blood pressure sensor is
configured to
determine a local blood pressure in the renal artery.
29. The system according to aspect 27 or 28, wherein the blood pressure
sensor is configured
to determine a systemic blood pressure.
30. The system according to any of aspects 27-29, wherein the control unit
is configured to
receive the signal generated by the blood pressure sensor.
31. The system according to aspect 30, wherein the control unit is
configured to control the
operation of the stimulation device based on the received signal.
32. The system according to any of the preceding aspects, further
comprising a coating (760)
arranged on at least one surface of at least one of the stimulation device,
the damping device, and
the control unit.
33. The system according to aspect 32, wherein the coating comprises at
least one layer of a
biomaterial.
34. The system according to aspect 33, wherein the biomaterial comprises at
least one drug or
substance with antithrombotic and/or antibacterial and/or antiplatelet
characteristics.
35. The system according to aspect 33 or 34, wherein the biomaterial is
fibrin-based.
36. The system according to any of aspects 33-36, further comprising a
second coating (760b)
arranged on the first coating.
37. The system according to aspect 36, wherein the second coating is a
different biomaterial
than said first coating.
38. The system according to aspect 37, wherein the first coating comprises
a layer of
perfluorocarbon chemically attached to the surface, and wherein the second
coating comprises a
liquid perfluorocarbon layer.
39. The system according to any one of aspects 36-38, wherein the
coating comprises a drug
encapsulated in a porous material.
40. The system according to any one of aspects 33-39, wherein the surface
comprises a metal.
41. The system according to aspect 40, wherein the metal comprises at
least one of titanium,
cobalt, nickel, copper, zinc, zirconium, molybdenum, tin and lead.
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42. The system according to any of aspects 33-41, wherein the surface
comprises a
micropattern.
43. The system according to aspect 42, wherein the micropattern is etched
into the surface
prior to insertion into the body.
44. The system according to aspect 42 or 43, further comprising a layer of
a biomaterial coated
on the micropattern.
45. A communication system for enabling communication between a display
device and a
system according to any of the preceding aspects, the communication system
comprising:
a display device,
a server, and
an external device,
wherein the display device comprises:
a wireless communication unit configured for wirelessly receiving an implant
control
interface from the server, the implant control interface being provided by the
external device, the
wireless communication unit further being configured for wirelessly
transmitting implant control
user input to the server, destined for the external device,
a display for displaying the received implant control interface, and
an input device for receiving implant control input from the user;
wherein the server comprises:
a wireless communication unit configured for wirelessly receiving an implant
control
interface from the external device and wirelessly transmitting the implant
control interface to the
display device, the wireless communication unit further being configured for
wirelessly receiving
implant control user input from the display device and wirelessly transmitting
the implant control
user input to the external device, and
wherein the external device comprises:
a wireless communication unit configured for wireless transmission of control
commands
to the system and configured for wireless communication with the server, and
a computing unit configured for:
running a control software for creating the control commands for the operation
of the
system,
transmitting a control interface to the server, destined for the display
device,
receiving implant control user input generated at the display device, from the
server, and
transforming the user input into the control commands for wireless
transmission to the
system.
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Aspect group 382SE2: Stimulation of spinal cord dispatching nerves
1. A system for treating a patient with stimulation of a spinal cord
dispatching nerve,
comprising:
a stimulation device comprising a first electrode arrangement configured to
deliver an
electric stimulation signal to at least one spinal cord dispatching nerve of a
patient to treat disease
affected by anyone of the spinal cord dispatching nerves;
a signal damping device comprising a second electrode arrangement configured
to deliver
an electric damping signal to dampen a stimulation distributed in a retrograde
direction back to the
brain of the patient;
a control unit operably connected to the stimulation device and to the signal
damping
device, wherein the control unit is configured to control an operation of the
stimulation device such
that the electric stimulation signal causes vasodilation of the renal artery,
and to control an
operation of the signal damping device to damp or disturb the electric
stimulation signal delivered
by the stimulation device.
2. The system according to aspect 1, wherein the second electrode
arrangement is configured
to deliver the electric damping signal to the same nerve to damp or reduce
transmission of the
electric stimulation signal in the backward direction of the nerve, preventing
stimulation of the
brain.
3. The system according to aspect 2, wherein the second electrode
arrangement is configured
to deliver the electric damping signal at a position between the first
electrode arrangement and a
proximal position of the at least one spinal cord dispatching nerve
stimulated.
4. The system according to aspect 1, wherein at least one of the first and
second electrode
arrangements comprises a plurality of electrode elements, each of which being
configured to
engage and electrically stimulate the nerve.
5. The system according to aspect 1, wherein at least one of the first and
second electrode
arrangements is arranged on a surface portion of a support structure, and
wherein the surface
portion is configured to be placed on or close relation to the at least one
spinal cord dispatching
nerve.
6. The system according to aspect 5, wherein the support structure
comprises a cuff
configured to be arranged at least partly around the at least one spinal cord
dispatching nerve.
7. The system according to aspect 6, wherein at least one of the first and
second electrode
arrangements is arranged on an inner surface of the cuff
8. The system
according to any of the preceding aspects, wherein each of the stimulation
device and the signal damping device is configured to deliver an electric
stimulation signal and an
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electric damping signal, respectively, to at least one of a parasympathetic
and at least one spinal
cord dispatching nerve.
9. The system according to any of the preceding aspects, wherein the
control unit is
configured to generate a pulsed electric stimulation signal for affecting the
at least one of a
parasympathetic and at least one spinal cord dispatching nerve.
10. The system according to aspect 9, wherein the electric stimulation
signal comprises a
frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz.
11. The system according to aspect 9 or 10, wherein the electric
stimulation signal comprises a
pulse width of 0.01-1 ms.
12. The system according to any of aspects 9 to 11, wherein the electric
stimulation signal
comprises a pulse amplitude of 1-15 mA.
13. The system according to any of the preceding aspects, wherein the
control unit if
configured to generate the electric damping signal based on the electric
stimulation signal.
14. The system according to aspect 13, wherein the electric damping signal
is out of phase with
the electric stimulation signal.
15. The system according to aspect 13, wherein the electric stimulation
signal and the electric
damping signal are pulsed signals, and wherein a frequency of the electric
damping signal is higher
than a frequency of the electric stimulation signal.
16. The system according to aspect 15, wherein the frequency of the
electric damping signal is
at least twice the frequency of the electric stimulation signal.
17. The system according to aspect 13, wherein the signal damping device is
configured to
deliver an electric scrambling signal for disturbing the electric stimulation
signal passing the signal
damping device.
18. The system according to any of the preceding aspects, further
comprising a signal
processing means configured to measure the electric stimulation signal
received at the signal
damping device and to generate the electric damping signal based on the
received electric
stimulation signal.
19. The system according to any of the preceding aspects, wherein the
control unit is
configured to be communicatively connected to a wireless remote control.
20. The system according to aspect 19, wherein the control unit comprises
an internal signal
transmitter configured to receive and transmit communication signals from/to
an external signal
transmitter.
21. The system according to any of the preceding aspects, further
comprising a source of
energy for energising the first and second electrode arrangements.
22. The system according to aspect 21, wherein the source of energy is
configured to be
implanted subcutaneously.
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23. The system according to aspect 21 or 22, wherein the source of energy
comprises at least
one of a primary cell and a secondary cell.
24. The system according to any of aspects 21 to 23, wherein the control
unit is configured to
indicate a functional status of the source of energy.
25. The system according to aspect 24, wherein the functional status
indicates a charge level of
the source of energy.
26. The system according to any of aspects 21-25, wherein the control
unit is configured to
indicate a temperature of at least one of the source of energy, the nerve and
tissue adjacent to the
nerve.
27. The system according to any of the preceding aspects, further
comprising a blood pressure
sensor configured to generate a signal indicating a blood pressure of the
patient.
28. The system according to aspect 27, wherein the blood pressure sensor is
configured to
determine a local blood pressure in the renal artery.
29. The system according to aspect 27 or 28, wherein the blood pressure
sensor is configured
to determine a systemic blood pressure.
30. The system according to any of aspects 27-29, wherein the control unit
is configured to
receive the signal generated by the blood pressure sensor.
31. The system according to aspect 30, wherein the control unit is
configured to control the
operation of the stimulation device based on the received signal.
32. The system according to any of the preceding aspects, further
comprising a coating (760)
arranged on at least one surface of at least one of the stimulation device,
the damping device, and
the control unit.
33. The system according to aspect 32, wherein the coating comprises at
least one layer of a
biomaterial.
34. The system according to aspect 33, wherein the biomaterial comprises at
least one drug or
substance with antithrombotic and/or antibacterial and/or antiplatelet
characteristics.
35. The system according to aspect 33 or 34, wherein the biomaterial is
fibrin-based.
36. The system according to any of aspects 33-36, further comprising a
second coating (760b)
arranged on the first coating.
37. The system according to aspect 36, wherein the second coating is a
different biomaterial
than said first coating.
38. The system according to aspect 37, wherein the first coating
comprises a layer of
perfluorocarbon chemically attached to the surface, and wherein the second
coating comprises a
liquid perfluorocarbon layer.
39. The system according to any one of aspects 36-38, wherein the coating
comprises a drug
encapsulated in a porous material.
40. The system according to any one of aspects 33-39, wherein the
surface comprises a metal.
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41. The system according to aspect 40, wherein the metal comprises at least
one of titanium,
cobalt, nickel, copper, zinc, zirconium, molybdenum, tin and lead.
42. The system according to any of aspects 33-41, wherein the surface
comprises a
micropattern.
43. The system according to aspect 42, wherein the micropattern is etched
into the surface
prior to insertion into the body.
44. The system according to aspect 42 or 43, further comprising a layer of
a biomaterial coated
on the micropattern.
45. A communication system for enabling communication between a display
device and a
system according to any of the preceding aspects, the communication system
comprising:
a display device,
a server, and
an external device,
wherein the display device comprises:
a wireless communication unit configured for wirelessly receiving an implant
control
interface from the server, the implant control interface being provided by the
external device, the
wireless communication unit further being configured for wirelessly
transmitting implant control
user input to the server, destined for the external device,
a display for displaying the received implant control interface, and
an input device for receiving implant control input from the user;
wherein the server comprises:
a wireless communication unit configured for wirelessly receiving an implant
control
interface from the external device and wirelessly transmitting the implant
control interface to the
display device, the wireless communication unit further being configured for
wirelessly receiving
implant control user input from the display device and wirelessly transmitting
the implant control
user input to the external device, and
wherein the external device comprises:
a wireless communication unit configured for wireless transmission of control
commands
to the system and configured for wireless communication with the server, and
a computing unit configured for:
running a control software for creating the control commands for the operation
of the
system,
transmitting a control interface to the server, destined for the display
device,
receiving implant control user input generated at the display device, from the
server, and
transforming the user input into the control commands for wireless
transmission to the
system.
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46. The system according to any of aspects 1 - 45, wherein the spinal cord
dispatching nerve
stimulation is adapted to treat at least one of problems related to the food
passageway and
associated organs, as well as other organs and functions in the body, such as
at least one of: an eye,
a lacrimal gland, mucosa membranes, a submaxillary gland, a sublingual gland,
a parotid gland, a
heart, a trachea, a bronchi, an esophagus, a stomach, intestines, abdominal
blood vessels, liver and
bile duct, pancreas, adrenal gland, rectum, as well as via coccyges nerves:
kidney, a urinary
bladder, gonads, external genitalia.
47. The system according to any of aspects 1 - 46, wherein the spinal cord
dispatching nerve
stimulation is adapted to treat a multitude of diseases comprising; high blood
pressure, obesity,
1 0 urinary dysfunction, intestinal dysfunction, hormonal balance etc.
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Aspect group 382SE3: Stimulation of spinal cord nerves
1. A system for treating a patient with stimulation of a spinal cord
dispatching nerve,
comprising:
a stimulation device comprising a first electrode arrangement configured to
deliver an
electric stimulation signal to at least one spinal cord dispatching nerve of a
patient to treat disease
affected by anyone of the spinal cord dispatching nerves;
a signal damping device comprising a second electrode arrangement configured
to deliver
an electric damping signal to damp stimulation distributed in a retrograde
direction back up to the
brain of the patient, which negatively could harm the patient;
a control unit operably connected to the stimulation device and to the signal
damping
device, wherein the control unit is configured to control an operation of the
stimulation device such
that the electric stimulation signal causes vasodilation of the renal artery,
and to control an
operation of the signal damping device to damp or disturb the electric
stimulation signal delivered
by the stimulation device.
2. The system according to aspect 1, wherein the second electrode
arrangement is configured
to deliver the electric damping signal to the same nerve to damp or reduce
transmission of the
electric stimulation signal in the backward direction of the nerve, preventing
stimulation of the
brain.
3. The system according to aspect 2, wherein the second electrode
arrangement is configured
to deliver the electric damping signal at a position between the first
electrode arrangement and a
proximal position of the at least one spinal cord dispatching nerve
stimulated.
4. The system according to aspect 1, wherein at least one of the first and
second electrode
arrangements comprises a plurality of electrode elements, each of which being
configured to
engage and electrically stimulate the nerve.
5. The system according to aspect 1, wherein at least one of the first and
second electrode
arrangements is arranged on a surface portion of a support structure, and
wherein the surface
portion is configured to be placed on or in close relation to the at least one
spinal cord dispatching
nerve.
6. The system according to aspect 5, wherein the support structure
comprises a cuff
configured to be arranged at least partly around the at least one spinal cord
dispatching nerve.
7. The system according to aspect 6, wherein at least one of the first and
second electrode
arrangements is arranged on an inner surface of the cuff
8. The system according to any of the preceding aspects, wherein each of
the stimulation
device and the signal damping device is configured to deliver an electric
stimulation signal and an
electric damping signal, respectively, to at least one of a parasympathetic
and at least one spinal
cord dispatching nerve.
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9. The system according to any of the preceding aspects, wherein the
control unit is
configured to generate a pulsed electric stimulation signal for affecting the
at least one of a
parasympathetic and at least one spinal cord dispatching nerve.
10. The system according to aspect 9, wherein the electric stimulation
signal comprises a
frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz.
11. The system according to aspect 9 or 10, wherein the electric
stimulation signal comprises a
pulse width of 0.01-1 ms.
12. The system according to any of aspects 9 to 11, wherein the electric
stimulation signal
comprises a pulse amplitude of 1-15 mA.
13. The system according to any of the preceding aspects, wherein the
control unit if
configured to generate the electric damping signal based on the electric
stimulation signal.
14. The system according to aspect 13, wherein the electric damping signal
is out of phase with
the electric stimulation signal.
15. The system according to aspect 13, wherein the electric stimulation
signal and the electric
damping signal are pulsed signals, and wherein a frequency of the electric
damping signal is higher
than a frequency of the electric stimulation signal.
16. The system according to aspect 15, wherein the frequency of the
electric damping signal is
at least twice the frequency of the electric stimulation signal.
17. The system according to aspect 13, wherein the signal damping device is
configured to
.. deliver an electric scrambling signal for disturbing the electric
stimulation signal passing the signal
damping device.
18. The system according to any of the preceding aspects, further
comprising a signal
processing means configured to measure the electric stimulation signal
received at the signal
damping device and to generate the electric damping signal based on the
received electric
stimulation signal.
19. The system according to any of the preceding aspects, wherein the
control unit is
configured to be communicatively connected to a wireless remote control.
20. The system according to aspect 19, wherein the control unit comprises
an internal signal
transmitter configured to receive and transmit communication signals from/to
an external signal
transmitter.
21. The system according to any of the preceding aspects, further
comprising a source of
energy for energising the first and second electrode arrangements.
22. The system according to aspect 21, wherein the source of energy is
configured to be
implanted subcutaneously.
23. The system according to aspect 21 or 22, wherein the source of energy
comprises at least
one of a primary cell and a secondary cell.
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24. The system according to any of aspects 21 to 23, wherein the control
unit is configured to
indicate a functional status of the source of energy.
25. The system according to aspect 24, wherein the functional status
indicates a charge level of
the source of energy.
26. The system according to any of aspects 21-25, wherein the control unit
is configured to
indicate a temperature of at least one of the source of energy, the nerve and
tissue adjacent to the
nerve.
27. The system according to any of the preceding aspects, further
comprising a blood pressure
sensor configured to generate a signal indicating a blood pressure of the
patient.
28. The system according to aspect 27, wherein the blood pressure sensor is
configured to
determine a local blood pressure in the renal artery.
29. The system according to aspect 27 or 28, wherein the blood pressure
sensor is configured
to determine a systemic blood pressure.
30. The system according to any of aspects 27-29, wherein the control unit
is configured to
receive the signal generated by the blood pressure sensor.
31. The system according to aspect 30, wherein the control unit is
configured to control the
operation of the stimulation device based on the received signal.
32. The system according to any of the preceding aspects, further
comprising a coating (760)
arranged on at least one surface of at least one of the stimulation device,
the damping device, and
the control unit.
33. The system according to aspect 32, wherein the coating comprises at
least one layer of a
biomaterial.
34. The system according to aspect 33, wherein the biomaterial comprises at
least one drug or
substance with antithrombotic and/or antibacterial and/or antiplatelet
characteristics.
35. The system according to aspect 33 or 34, wherein the biomaterial is
fibrin-based.
36. The system according to any of aspects 33-36, further comprising a
second coating (760b)
arranged on the first coating.
37. The system according to aspect 36, wherein the second coating is a
different biomaterial
than said first coating.
38. The system according to aspect 37, wherein the first coating comprises
a layer of
perfluorocarbon chemically attached to the surface, and wherein the second
coating comprises a
liquid perfluorocarbon layer.
39. The system according to any one of aspects 36-38, wherein the
coating comprises a drug
encapsulated in a porous material.
40. The system according to any one of aspects 33-39, wherein the surface
comprises a metal.
41. The system according to aspect 40, wherein the metal comprises at
least one of titanium,
cobalt, nickel, copper, zinc, zirconium, molybdenum, tin and lead.
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42. The system according to any of aspects 33-41, wherein the surface
comprises a
micropattern.
43. The system according to aspect 42, wherein the micropattern is etched
into the surface
prior to insertion into the body.
44. The system according to aspect 42 or 43, further comprising a layer of
a biomaterial coated
on the micropattern.
45. A communication system for enabling communication between a display
device and a
system according to any of the preceding aspects, the communication system
comprising:
a display device,
a server, and
an external device,
wherein the display device comprises:
a wireless communication unit configured for wirelessly receiving an implant
control
interface from the server, the implant control interface being provided by the
external device, the
wireless communication unit further being configured for wirelessly
transmitting implant control
user input to the server, destined for the external device,
a display for displaying the received implant control interface, and
an input device for receiving implant control input from the user;
wherein the server comprises:
a wireless communication unit configured for wirelessly receiving an implant
control
interface from the external device and wirelessly transmitting the implant
control interface to the
display device, the wireless communication unit further being configured for
wirelessly receiving
implant control user input from the display device and wirelessly transmitting
the implant control
user input to the external device, and
wherein the external device comprises:
a wireless communication unit configured for wireless transmission of control
commands
to the system and configured for wireless communication with the server, and
a computing unit configured for:
running a control software for creating the control commands for the operation
of the
system,
transmitting a control interface to the server, destined for the display
device,
receiving implant control user input generated at the display device, from the
server, and
transforming the user input into the control commands for wireless
transmission to the
system.
46. The system according to any of the preceding aspecta, wherein the
spinal cord dispatching
nerve stimulation is adapted to treat at least one of problems related to the
food passageway and
associated organs, as well as many organs and functions in the body, at least
one of; an eye, a
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lacrimal gland, mucosa membranes, a submaxillary gland, a sublingual gland, a
parotid gland, a
heart, a trachea, a bronchi, an esophagus, a stomach, intestines, abdominal
blood vessels, liver and
bile duct, pancreas, adrenal gland, rectum, as well as via coccyges nerves:
kidney, a urinary
bladder, gonads, external genitalia.
47. The system according to any of the preceding aspects, wherein the
spinal cord dispatching
nerve stimulation is adapted to treat a multitude of diseases comprising; high
blood pressure,
obesity, urinary dysfunction, intestinal dysfunction, hormonal balance etc.
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Aspect group 404SE: Hypertension Local Treatment Energising
1. A system for treating a patient with hypertension, comprising:
a stimulation device comprising an electrode arrangement configured to be able
to deliver
an electric stimulation signal to at least one of: a wall portion of a renal
artery and a
parasympathetic nerve innervating the renal artery of the patient, to affect a
dilation of the renal
artery;
a implantable energy receiver configured to energize the electrode
arrangement;
an energy source configured to transfer energy wirelessly to the energy
receiver; and
a control unit operably connected to the stimulation device;
1 0 wherein the control unit is configured to control an operation of the
stimulation device such
that the electric stimulation signal causes a controlled vasodilation of the
renal artery.
2. The system according to aspect 1, wherein the energy receiver comprises
an inductive coil
arrangement configured to receive the wirelessly transmitted energy from the
energy source.
3. The system according to aspect 1 or 2, wherein the energy source is
configured to be
arranged outside the bod of the patient.
4. The system according to aspect 1 or 2, wherein the energy source is
configured to be
implanted in the patient.
5. The system according to aspect 4, wherein the energy source is
configured to be charged by
energy transferred wirelessly from outside the body of the patient
6. The system according to any of the preceding aspects, wherein the
control unit is
configured to generate control instructions for controlling the operation of
the stimulation device,
and to transmit the control instructions wirelessly from outside of the body
of the patient to the
stimulation device.
7. The system according to aspect 6, wherein the control unit comprises an
external part
configured to be arranged outside the body of the patient and an internal part
configured to be
implanted in the patient, and wherein the internal and external parts are
configured to communicate
wirelessly with each other.
8. The system according to aspect 7, wherein the internal and external
parts are configured to
communicate with each other by means of radiofrequency signals or inductive
signals.
9. The system according to any of the preceding aspects, further
comprising:
a sensor configured to generate a signal indicative of the vasodilation of the
renal artery;
wherein:
the control unit is communicatively connected to the sensor device; and
configured to control the operation of the stimulation device based on the
signal generated
by the sensor device.
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10. The system according to aspect 9, wherein the sensor is configured to
measure a change in
the vasomotor tone of the smooth muscle tissue of the renal artery in response
to the electrical
stimulation of the wall portion.
11. The system according to aspect 9, wherein the sensor is configured to
measure a degree of
vasodilation of the renal artery.
12. The system according to aspect 9, wherein the sensor is configured to
measure a flow of
blood through the renal artery.
13. The system according to aspect 9, wherein the sensor is configured to
measure a blood
pressure of the patient.
14. The system according to aspect 9, wherein the sensor comprises a
pressure sensor
configured to be arranged in a blood vessel of the patient.
15. The system according to aspect 9, wherein the sensor is configured to
be arranged at an
outer wall of a blood vessel of the patient.
16. The system according to aspect 15, wherein the sensor is configured to
measure a pressure
pulse wave transmitted from the blood flow to the outer wall of the blood
vessel.
17. The system according to aspect 15, wherein the sensor comprises a
strain gauge sensitive to
strain in the outer wall of the blood vessel.
18. The system according to aspect 15 or 16, wherein the sensor comprises a
contact pressure
sensor sensitive to a pressing force between the outer wall of the blood
vessel and the pressure
sensor.
19. The system according to aspect 15, wherein the sensor comprises a light
source and a light
sensor, and wherein the signal is based on a light coupling efficiency between
the light source and
the light sensor.
20. The system according to aspect 9, wherein the sensor is configured to
generate a signal
indicative of a vascular resistance in a portion of the circulatory system of
the patient.
21. The system according to any of aspects 9-20, wherein the control unit
is configured to:
determine an estimated blood pressure based the on signal generated by the
sensor;
wherein the determined blood pressure is a local blood pressure in the renal
artery or a
systemic blood pressure.
22. The system according to aspect 21, wherein the control unit is
configured to:
compare the estimated blood pressure with a predetermined limit value; and
in response to the estimated blood pressure being below the limit value,
control the
operation of the stimulation device to cause vasoconstriction of the renal
artery; and
in response to the estimated blood pressure exceeding the limit value, control
the operation
of the stimulation device to cause vasodilation of the renal artery.
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23. The system according to aspect 21, wherein the control unit is
configured to:
monitor, over time, the estimated blood pressure based on the signal generated
by the
sensor; and
in response to the estimated blood pressure sinking over time, control the
operation of the
stimulation device to cause vasoconstriction of the renal artery; and
in response to the estimated blood pressure rising over time, control the
operation of the
stimulation device to cause vasodilation of the renal artery.
24. The system according to any of the preceding aspects, wherein the
electrode arrangement
comprises a plurality of electrode elements, each of which being configured to
engage and
electrically stimulate the wall portion of the renal artery or the nerve
innervating the renal artery.
25. The system according to any of the preceding aspects, wherein the
electrode arrangement is
configured to electrically stimulate a sacral nerve.
26. The system according to any of the preceding aspects, wherein the
control unit is
configured to generate a pulsed electrical stimulation signal for affecting
the vasomotor tone of the
smooth muscle tissue of the renal artery.
27. The system according to aspect 26, wherein the electrical stimulation
signal comprises at
least one of:
a frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz,
a pulse width of 0.01-1 ms, and
a pulse amplitude of 1-15 mA.
28. The system according to any of the preceding aspects, further
comprising a signal damping
device configured to be arranged at the parasympathetic nerve, at a position
between the
stimulation device and the spinal cord.
29. The system according to aspect 28, wherein the signal damping device
comprises an
electrode arrangement configured to deliver an electric damping signal to the
parasympathetic
nerve, and wherein the electric damping signal is configured to at least
partly counteract the
electrical stimulation signal generated by the stimulation device.
30. The system according to aspect 29, wherein the signal damping device
further comprises a
signal processing means configured to measure the electrical stimulation
signal received at the
signal damping device and generate the electric damping signal based on the
received electrical
stimulation signal.
31. The system according to any of the preceding aspects, wherein the
stimulation device is
adapted to stimulate a parasympathetic nerve system, such as at least a branch
of spinal cord
dispatching nerve number 10 and the Coccygeal nerves originating from
vertebrae S2-S4,
preferably S4.
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32. The system according to any of the preceding aspects, wherein the
stimulation device is
adapted to affect a vasomotor tone of a smooth muscle tissue of the renal
artery.
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Aspect group 405 SE: Hypertension Local Treatment Communication
1. A system for treating a patient with hypertension, comprising:
a stimulation device comprising an electrode arrangement configured to be able
to deliver
an electric stimulation signal to at least one of: a wall portion of a renal
artery and a
parasympathetic nerve innervating the renal artery of the patient, to affect a
vasomotor tone of the
renal artery;
a source of energy configured to energize the electrode arrangement; and
a control unit operably connected to the stimulation device;
wherein the control unit is configured to:
generate control instructions for controlling the operation of the stimulation
device such
that the electric stimulation signal causes a controlled vasodilation of the
renal artery; and
transmit the control instructions wirelessly to the stimulation device.
2. The system according to aspect 1, wherein the control unit comprises an
external part
configured to be arranged outside the body of the patient and an internal part
configured to be
implanted in the patient, and wherein the internal and external parts are
configured to communicate
wirelessly with each other.
3. The system according to aspect 2, wherein the internal and external
parts are configured to
communicate with each other by means of radiofrequency signals or inductive
signals.
4. The system according to any of the preceding aspects, wherein the source
of energy is
configured to be arranged outside the body of the patient and to energize the
electrode arrangement
by transferring energy wirelessly to the electrode arrangement.
5. The system according to aspect 4, further comprising an implantable
energy receiver
configured to receive energy, transferred wirelessly from the source of
energy, and transmit the
received energy to the electrode arrangement.
6. The system according to aspect 5, wherein the implantable energy
receiver comprises an
inductive coil arrangement configured to receive the wirelessly transmitted
energy from the source
of energy.
7. The system according to aspect 1, wherein the source of energy is
configured to be
implanted in the patient.
8. The system according to aspect 7, wherein the source of energy is
configured to be charged
by energy transferred wirelessly from outside the body of the patient
9. The system according to aspect 8, further comprising an implantable
energy receiver
configured to receive energy, transferred wirelessly from outside the body of
the patient, and
transmit the received energy to the source of energy implanted in the patient.
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10. The system according to aspect 9, wherein the implantable energy
receive comprises an
inductive coil arrangement configured to receive the wirelessly transmitted
energy.
11. The system according to any of the preceding aspects, further
comprising:
a sensor configured to generate a signal indicative of the vasodilation of the
renal artery;
wherein:
the control unit is communicatively connected to the sensor device; and
configured to control the operation of the stimulation device based on the
signal generated
by the sensor device.
12. The system according to aspect 11, wherein the sensor is configured to
measure a change in
the vasomotor tone of the smooth muscle tissue of the renal artery in response
to the electrical
stimulation of the wall portion.
13. The system according to aspect 11, wherein the sensor is configured to
measure a degree of
vasodilation of the renal artery.
14. The system according to aspect 11, wherein the sensor is configured to
measure a flow of
blood through the renal artery.
15. The system according to aspect 11, wherein the sensor is configured to
measure a blood
pressure of the patient.
16. The system according to aspect 11, wherein the sensor comprises a
pressure sensor
configured to be arranged in a blood vessel of the patient.
17. The system according to aspect 11, wherein the sensor is configured to
be arranged at an
outer wall of a blood vessel of the patient.
18. The system according to aspect 17, wherein the sensor is configured to
measure a pressure
pulse wave transmitted from the blood flow to the outer wall of the blood
vessel.
19. The system according to aspect 17, wherein the sensor comprises a
strain gauge sensitive to
strain in the outer wall of the blood vessel.
20. The system according to aspect 19 or 20, wherein the sensor comprises a
contact pressure
sensor sensitive to a pressing force between the outer wall of the blood
vessel and the pressure
sensor.
21. The system according to aspect 11, wherein the sensor comprises a light
source and a light
sensor, and wherein the signal is based on a light coupling efficiency between
the light source and
the light sensor.
22. The system according to aspect 11, wherein the sensor is configured to
generate a signal
indicative of a vascular resistance in a portion of the circulatory system of
the patient.
23. The system according to any of aspects 11-22, wherein the control unit
is configured to:
determine an estimated blood pressure based the on signal generated by the
sensor;
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wherein the determined blood pressure is a local blood pressure in the renal
artery or a
systemic blood pressure.
24. The system according to aspect 23, wherein the control unit is
configured to:
compare the estimated blood pressure with a predetermined limit value; and
in response to the estimated blood pressure being below the limit value,
control the
operation of the stimulation device to cause vasoconstriction of the renal
artery; and
in response to the estimated blood pressure exceeding the limit value, control
the operation
of the stimulation device to cause vasodilation of the renal artery.
25. The system according to aspect 23, wherein the control unit is
configured to:
monitor, over time, the estimated blood pressure based on the signal generated
by the
sensor; and
in response to the estimated blood pressure sinking over time, control the
operation of the
stimulation device to cause vasoconstriction of the renal artery; and
in response to the estimated blood pressure rising over time, control the
operation of the
stimulation device to cause vasodilation of the renal artery.
26. The system according to any of the preceding aspects, wherein the
electrode arrangement
comprises a plurality of electrode elements, each of which being configured to
engage and
electrically stimulate the wall portion of the renal artery or the nerve
innervating the renal artery.
27. The system according to any of the preceding aspects, wherein the
electrode arrangement is
configured to electrically stimulate a sacral nerve.
28. The system according to any of the preceding aspects, wherein the
control unit is
configured to generate a pulsed electrical stimulation signal for affecting
the vasomotor tone of the
smooth muscle tissue of the renal artery.
29. The system according to aspect 28, wherein the electrical stimulation
signal comprises at
least one of:
a frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz,
a pulse width of 0.01-1 ms, and
a pulse amplitude of 1-15 mA.
30. The system according to any of the preceding aspects, further
comprising a signal damping
device configured to be arranged at the parasympathetic nerve, at a position
between the
stimulation device and the spinal cord.
31. The system according to aspect 30, wherein the signal damping device
comprises an
electrode arrangement configured to deliver an electric damping signal to the
parasympathetic
nerve, and wherein the electric damping signal is configured to at least
partly counteract the
electrical stimulation signal generated by the stimulation device.
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32. The system according to aspect 31, wherein the signal damping device
further comprises a
signal processing means configured to measure the electrical stimulation
signal received at the
signal damping device and generate the electric damping signal based on the
received electrical
stimulation signal.
33. The system according to any of the preceding aspects, wherein the
stimulation device is
configured to affect a vasomotor tone of the smooth muscle tissue of the renal
artery.
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Aspect group 406SE: Hypertension_Elongated_Holder
1. A system for treating a patient with hypertension, comprising:
a stimulation device comprising an electrode arrangement configured to be able
to deliver
an electric stimulation signal to at least one of: a wall portion of a renal
artery and a
parasympathetic nerve innervating the renal artery of the patient, to affect a
vasomotor tone of the
renal artery;
a source of energy configured to energize the electrode arrangement;
a control unit operably connected to the stimulation device; and
an elongated holding device configured to be attached to an outer wall of the
renal artery
1 0 such that a length direction of the holding device extends along a flow
direction of the renal artery,
wherein the holding device is further configured to support the electrode
arrangement to allow the
electrode arrangement to deliver the electric stimulation signal to the wall
portion;
wherein the control unit is configured to control an operation of the
stimulation device such
that the electric stimulation signal causes a controlled vasodilation of the
renal artery.
2. The system according to aspect 1, wherein the electrode arrangement is
attached to a
surface portion of the holding device and configured to rest against the outer
wall of the renal
artery.
3. The system according to aspect 1 or 2, further comprising an
attachment device configured
to fixate the holding device to the renal artery.
4. The system according to aspect 3, wherein the attachment device
comprises at least one of
a suture configured to be sutured to the renal artery and a clamping device
configured to at least
partly encircle the renal artery.
5. The system according to aspect 3, wherein the attachment device is
configured to be
attached to the holding device and a tissue portion external to the renal
artery.
6. The system according to any of the preceding aspects, wherein the
holding device is
flexible.
7. The system according to any of the preceding aspects, wherein at least
one of the source of
energy and the control unit is accommodated in the holding device.
8. The system according to any of the preceding aspects, wherein the
electrode arrangement
comprises a plurality of electrode elements, each of which being configured to
engage and
electrically stimulate the wall portion of the renal artery or the nerve
innervating the renal artery.
9. The system according to any of the preceding aspects, wherein the
electrode arrangement is
configured to electrically stimulate a sacral nerve.
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10. The system according to any of the preceding aspects, wherein the
control unit is
configured to generate a pulsed electrical stimulation signal for affecting
the vasomotor tone of the
smooth muscle tissue of the renal artery.
11. The system according to aspect 10, wherein the electrical stimulation
signal comprises at
.. least one of:
a frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz,
a pulse width of 0.01-1 ms, and
a pulse amplitude of 1-15 mA.
12. The system according to any of the preceding aspects, further
comprising a signal damping
device configured to be arranged at the parasympathetic nerve, at a position
between the
stimulation device and the spinal cord.
13. The system according to aspect 12, wherein the signal damping device
comprises an
electrode arrangement configured to deliver an electric damping signal to the
parasympathetic
nerve, and wherein the electric damping signal is configured to at least
partly counteract the
electrical stimulation signal generated by the stimulation device.
14. The system according to aspect 13, wherein the signal damping device
further comprises a
signal processing means configured to measure the electrical stimulation
signal received at the
signal damping device and generate the electric damping signal based on the
received electrical
stimulation signal.
15. The system according to any of the preceding aspects, further
comprising a blood pressure
sensor configured to generate a signal indicating a blood pressure of the
patient.
16. The system according to aspect 15, wherein the control unit is
configured to control the
operation of the stimulation device based on the signal.
17. The system according to any of the preceding aspects, wherein the
stimulation device is
configured to affect a vasomotor tone of the smooth muscle tissue of the renal
artery
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Aspect group 407SE: HypertensionSompliant_Cuff
1. A system for treating a patient suffering from hypertension, comprising:
a stimulation device comprising an electrode arrangement configured to be able
to deliver
an electric stimulation signal to at least one of: a wall portion of a renal
artery and a
parasympathetic nerve innervating the renal artery of the patient, to affect a
vasomotor tone of of
the renal artery;
a source of energy configured to energize the electrode arrangement;
a control unit operably connected to the stimulation device and configured to
control an
operation of the stimulation device such that the electric stimulation signal
causes a controlled
1 0 vasodilation of the renal artery; and
a holding device configured to support the electrode arrangement at the outer
wall of the
renal artery to allow the electrode arrangement to deliver the electric
stimulation signal to the wall
portion,
wherein the holding device is configured to at least partly define a passage
through which
the renal artery passes; and
wherein the holding device is configured to allow a width of the passage to
follow changes
in a width of the renal artery, such that the width of the passage increases
with increased
vasodilation and decreases with decreasing vasodilation.
2. The system according to aspect 1, wherein the holding device comprises a
flexible portion
configured to rest against the outer wall of the renal artery and to follow a
motion of the outer wall
as the width of the renal artery varies in response to the vasodilation.
3. The system according to aspect 1, wherein the holding device comprises a
cuff arranged to
at least partly encircle the renal artery.
4. The system according to aspect 3, wherein the cuff comprises at least
one abutment
element having a varying volume and configured to rest against the outer wall
portion of the renal
artery.
5. The system according to aspect 4, wherein the abutment element comprises
an inflatable
element configured to vary its volume in response to the width of the renal
artery varying with the
vasodilation.
6. The system according to aspect 4 or 5, wherein the abutment element
comprises a
pneumatic or hydraulic element having an adjustable volume.
7. The system according to aspect 6, further comprising a fluid reservoir,
wherein the
pneumatic or hydraulic element is fluidly connected to the fluid reservoir.
8. The system according to any of the preceding aspects, further comprising
a pressure sensor
device arranged to sense generate a signal indicative of a contact pressure
between the holding
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device and the outer wall of the renal artery, wherein the control unit is
further configured to cause
the width of the passage of the holding device to vary based on the signal
from the pressure sensor.
9. The system according to aspect 8, wherein the control unit is configured
to operate the
holding device to maintain a substantially constant contact pressure between
the holding device and
the outer wall as the width of the renal artery varies with the vasodilation.
10. The system according to aspect 8, wherein the control unit is
configured to control an
operation of the stimulation device based on the signal generated by the
sensor device.
11. The system according to aspect 1, further comprising a sensor
configured to generate a
signal indicative of a blood pressure of the patient; wherein the control unit
is configured to control
an operation of the stimulation device based on the signal generated by the
sensor device.
12. The system according to aspect 11, wherein the sensor is integrated in
the holding device.
13. The system according to aspect 12, wherein the sensor is configured to
measure a pressure
pulse wave transmitted from the blood flow in the renal artery to the outer
wall of the renal artery.
14. The system according to aspect 12 or 13, wherein the sensor comprises a
contact pressure
sensor sensitive to a pressing force between the outer wall of the renal
artery and the pressure
sensor.
15. The system according to any of aspects 11-13, wherein the sensor
comprises a strain gauge
sensitive to strain in the outer wall of the renal artery.
16. The system according to any of aspects 11-15, wherein the sensor
comprises a light source
and a light sensor, and wherein the signal is based on a light coupling
efficiency between the light
source and the light sensor.
17. The system according to aspect 11, wherein the sensor is a flow sensor
configured to
generate a signal indicative of a flow through the renal artery.
18. The system according to aspect 11, wherein the sensor is configured to
generate a signal
indicative of a vascular resistance in a portion of the circulatory system of
the patient.19.
The system according to any of aspects 11-18, wherein the control unit is
configured to:
determine an estimated blood pressure based the on signal generated by the
sensor;
wherein the determined blood pressure is a local blood pressure in the renal
artery or a
systemic blood pressure.
20. The system according to aspect 19, wherein the control unit is
configured to:
compare the estimated blood pressure with a predetermined limit value; and
in response to the estimated blood pressure being below the limit value,
control the
operation of the stimulation device to cause vasoconstriction of the renal
artery; and
in response to the estimated blood pressure exceeding the limit value, control
the operation
of the stimulation device to cause vasodilation of the renal artery.
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21. The system according to aspect 19, wherein the control unit is
configured to:
monitor, over time, the estimated blood pressure based on the signal generated
by the
sensor; and
in response to the estimated blood pressure sinking over time, control the
operation of the
stimulation device to cause vasoconstriction of the renal artery; and
in response to the estimated blood pressure rising over time, control the
operation of the
stimulation device to cause vasodilation of the renal artery.
22. The system according to any of the preceding aspects, wherein the
control unit is
configured to generate a pulsed electrical stimulation signal for affecting
the vasomotor tone of the
smooth muscle tissue of the renal artery.
23. The system according to aspect 22, wherein the electrical stimulation
signal comprises at
least one of:
a frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz,
a pulse width of 0.01-1 ms, and
a pulse amplitude of 1-15 mA.
24. The system according to any of the preceding aspects, further
comprising a signal damping
device configured to be arranged at the nerve innervating the renal artery, at
a position between the
stimulation device and the spinal cord.
25. The system according to aspect 24, wherein the signal damping device
comprises an
electrode arrangement configured to deliver an electric damping signal to the
nerve, and wherein
the electric damping signal is configured to at least partly counteract the
electrical stimulation
signal generated by the stimulation device.
26. The system according to aspect 25, wherein the signal damping device
further comprises a
signal processing means configured to measure the electrical stimulation
signal received at the
signal damping device and generate the electric damping signal based on the
received electrical
stimulation signal.
27. The system according to any of the preceding aspects, wherein the
stimulation device is
configured to affect a vasomotor tone of the smooth muscle tissue of the renal
artery
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Aspect group 408 SE: Hypertensionintraluminar_Heating
1. A system for treating a patient with hypertension, comprising:
a stimulation device having a heating member configured to be implanted inside
a renal
artery of the patient;
an implantable source of energy configured to energize the stimulation device;
and
a control unit operably connected to the stimulation device;
wherein the control unit is configured to control an operation of the
stimulation device such
that heat is exchanged between the heating member and a wall portion of the
renal artery to cause a
controlled a of the renal artery.
2. The system according to aspect 1, wherein the source of energy is
configured to be
implanted inside the renal artery.
3. The system according to aspect 2, wherein the source of energy is
integrated in the heating
member.
4. The system according to aspect 2 or 3, wherein the source of energy is
configured to be
charged by energy transferred from outside the renal artery.
5. The system according to aspect 4, wherein the source of energy is
configured to be charged
by energy wirelessly transferred from outside the renal artery.
6. The system according to aspect 1, wherein the heating member is
configured to be heated
by energy transferred from outside the renal artery.
7. The system according to aspect 6, wherein the heating member is
configured to be heated
by energy transferred from outside the renal artery by means of a wired
connection.
8. The system according to aspect 6, wherein the heating member is
configured to be
inductively heated by energy transferred from outside the renal artery.
9. The system according to any of the preceding aspects, wherein the
heating member has a
tubular shape having an outer surface configured to rest against an inner
surface of the renal artery.
10. The system according to any of the preceding aspects, wherein the
heating member defines
a passage through which a blood flow of the renal artery is allowed to pass,
and wherein the
heating member is configured to follow change in a width of the renal artery
such that a width of
the passage increases with increased vasodilation and decreases with
decreasing vasodilation.
11. The system according to aspect 10, wherein the heating member comprises
a flexible
portion configured to allow the heating member to follow the change in width
of the renal artery.
12. The system according to aspect 10, wherein the heating member
comprises a shape
memory material configured to vary the width of the passage in response to a
varying temperature
of the heating member, thereby allowing the heating member to follow the
changes in the width of
the renal artery.
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13. The system according to any of the preceding aspects, wherein the
heating member
comprises a biocompatible material configured to promote fibrotic tissue
growth thereon.
14. The system according to aspect 13, wherein the heating member is
configured to be at least
partly encapsulated by fibrotic tissue when implanted in the renal artery.
15. The system according to any of the preceding aspects, wherein the
heating member is
configured to be secured to an inner surface of the renal artery.
16. The system according to aspect 15, wherein the heating member is
configured to be
secured to the inner surface by means of sutures or staples.
17. The system according to any of the preceding aspects, further
comprising:
a sensor configured to generate a signal indicative of the vasodilation of the
renal artery;
wherein:
the control unit is communicatively connected to the sensor device; and
configured to control the operation of the stimulation device based on the
signal generated
by the sensor device.
18. The system according to aspect 17, wherein the sensor is configured to
measure a flow of
blood through the renal artery.
19. The system according to aspect 17, wherein the sensor is configured to
measure a blood
pressure of the patient.
20. The system according to aspect 17, wherein the sensor comprises a
pressure sensor
configured to be arranged in a blood vessel of the patient.
21. The system according to aspect 17, wherein the sensor is configured to
be arranged at an
outer wall of a blood vessel of the patient.
22. The system according to aspect 21, wherein the sensor is configured to
measure a pressure
pulse wave transmitted from the blood flow to the outer wall of the blood
vessel.
23. The system according to aspect 21, wherein the sensor comprises a
strain gauge sensitive to
strain in the outer wall of the blood vessel.
24. The system according to aspect 21 or 22, wherein the sensor
comprises a contact pressure
sensor sensitive to a pressing force between the outer wall of the blood
vessel and the pressure
sensor.
25. The system according to aspect 17, wherein the sensor comprises a light
source and a light
sensor, and wherein the signal is based on a light coupling efficiency between
the light source and
the light sensor.
26. The system according to aspect 17, wherein the sensor is configured
to generate a signal
indicative of a vascular resistance in a portion of the circulatory system of
the patient.
27. The system according to any of aspects 17-26, wherein the control unit
is configured to:
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determine an estimated blood pressure based the on signal generated by the
sensor;
wherein the determined blood pressure is a local blood pressure in the renal
artery or a
systemic blood pressure.
28. The system according to aspect 27, wherein the control unit is
configured to:
compare the estimated blood pressure with a predetermined limit value; and
in response to the estimated blood pressure being below the limit value,
control the
operation of the stimulation device to cause vasoconstriction of the renal
artery; and
in response to the estimated blood pressure exceeding the limit value, control
the operation
of the stimulation device to cause vasodilation of the renal artery.
29. The system according to aspect 27, wherein the control unit is
configured to:
monitor, over time, the estimated blood pressure based on the signal generated
by the
sensor; and
in response to the estimated blood pressure sinking over time, control the
operation of the
stimulation device to cause vasoconstriction of the renal artery; and
in response to the estimated blood pressure rising over time, control the
operation of the
stimulation device to cause vasodilation of the renal artery.
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Aspect group 409SE: Hypertensionintraluminar_Expansion
1. A system for treating a patient with hypertension, comprising:
a dilation device having an expansion member configured to be implanted inside
a renal
artery of the patient and to engage at least a portion of an inner
circumferential surface of the renal
artery, wherein the expansion member expandable to increase a width of the
renal artery;
an implantable source of energy configured to energize the dilation device;
and
a control unit operably connected to the dilation device;
wherein the control unit is configured to control an operation of the dilation
device to
induce a controlled vasodilation of the renal artery.
2. The system according to aspect 1, wherein the source of energy is
configured to be
implanted inside the renal artery.
3. The system according to aspect 2, wherein the source of energy is
integrated in the
expansion member.
4. The system according to aspect 2 or 3, wherein the source of energy is
configured to be
charged by energy transferred from outside the renal artery.
5. The system according to aspect 4, wherein the source of energy is
configured to be charged
by energy wirelessly transferred from outside the renal artery.
6. The system according to aspect 1, wherein the expansion member is
configured to be
powered by energy transferred from outside the renal artery.
7. The system according to aspect 6, wherein the expansion member is
configured to be
powered by energy transferred from outside the renal artery by means of a
wired connection.
8. The system according to aspect 6, wherein the expansion member is
configured to be
inductively powered by energy transferred from outside the renal artery.
9. The system according to any of the preceding aspects, wherein the
expansion member is
configured to be operated by means of mechanic, hydraulic or thermal action.
10. The system according to aspect 9, further comprising an operation
device configured to
control the operation of the expansion member.
11. The system according to aspect 10, wherein the operation device
comprises a hydraulic
reservoir in fluid connection with the expansion member.
12. The system according to aspect 9, wherein the expansion member
comprises a shape
memory material configured to vary a shape of the expansion member in response
to a varying
temperature of the expansion member.
13. The system according to any of the preceding aspects, wherein the
expansion member has a
tubular shape having an outer surface configured to rest against an inner
surface of the renal artery.
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14. The system according to any of the preceding aspects, wherein the
expansion member
defines a passage through which a blood flow of the renal artery is allowed to
pass, and wherein the
expansion member is configured to cause vasodilation by increasing a width of
the passage.
15. The system according to any of the preceding aspects, wherein the
expansion member
comprises a biocompatible material configured to promote fibrotic tissue
growth thereon.
16. The system according to aspect 15, wherein the expansion member is
configured to be at
least partly encapsulated by fibrotic tissue when implanted in the renal
artery.
17. The system according to any of the preceding aspects, wherein the
expansion member is
configured to be secured to an inner surface of the renal artery.
18. The system according to aspect 17, wherein the expansion member is
configured to be
secured to the inner surface by means of sutures or staples.
19. The system according to any of the preceding aspects, further
comprising:
a sensor configured to generate a signal indicative of the vasodilation of the
renal artery;
wherein:
the control unit is communicatively connected to the sensor device; and
configured to control the operation of the stimulation device based on the
signal generated
by the sensor device.
20. The system according to aspect 19, wherein the sensor is configured to
measure a flow of
blood through the renal artery.
21. The system according to aspect 19, wherein the sensor is configured to
measure a blood
pressure of the patient.
22. The system according to aspect 18, wherein the sensor comprises a
pressure sensor
configured to be arranged in a blood vessel of the patient.
23. The system according to aspect 18, wherein the sensor is configured to
be arranged at an
outer wall of a blood vessel of the patient.
24. The system according to aspect 23, wherein the sensor is configured to
measure a pressure
pulse wave transmitted from the blood flow to the outer wall of the blood
vessel.
25. The system according to aspect 23, wherein the sensor comprises a
strain gauge sensitive to
strain in the outer wall of the blood vessel.
26. The system according to aspect 23 or 24, wherein the sensor comprises a
contact pressure
sensor sensitive to a pressing force between the outer wall of the blood
vessel and the pressure
sensor.
27. The system according to aspect 19, wherein the sensor comprises a
light source and a light
sensor, and wherein the signal is based on a light coupling efficiency between
the light source and
the light sensor.
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28. The system according to aspect 19, wherein the sensor is configured to
generate a signal
indicative of a vascular resistance in a portion of the circulatory system of
the patient.
29. The system according to any of aspects 19-28, wherein the control unit
is configured to:
determine an estimated blood pressure based the on signal generated by the
sensor;
wherein the determined blood pressure is a local blood pressure in the renal
artery or a
systemic blood pressure.
30. The system according to aspect 29, wherein the control unit is
configured to:
compare the estimated blood pressure with a predetermined limit value; and
in response to the estimated blood pressure being below the limit value,
control the
1 0 .. operation of the stimulation device to cause vasoconstriction of the
renal artery; and
in response to the estimated blood pressure exceeding the limit value, control
the operation
of the stimulation device to cause vasodilation of the renal artery.
31. The system according to aspect 29, wherein the control unit is
configured to:
monitor, over time, the estimated blood pressure based on the signal generated
by the
1 5 sensor; and
in response to the estimated blood pressure sinking over time, control the
operation of the
stimulation device to cause vasoconstriction of the renal artery; and
in response to the estimated blood pressure rising over time, control the
operation of the
stimulation device to cause vasodilation of the renal artery.
