Note: Descriptions are shown in the official language in which they were submitted.
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ELECTRONIC IMPLANTABLE PENILE PROSTHESIS
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of, and claims priority to,
U.S.
Nonprovisional Patent Application No. 18/068,074, filed on December 19, 2022,
entitled "ELECTRONIC IMPLANTABLE PENILE PROSTHESIS", which claims
priority to U.S. Provisional Patent Application No. 63/265,808, filed on
December 21,
2021, entitled "ELECTRONIC IMPLANTABLE PENILE PROSTHESIS", the
disclosures of which are incorporated by reference herein in their entirety.
[0002] This application also claims priority to U.S. Provisional Patent
Application No. 63/265,808, filed on December 21, 2021, the disclosure of
which is
incorporated by reference herein in its entirety.
TECHNICAL FIELD
[0003] This disclosure relates generally to bodily implants and more
specifically to bodily implants, such as an electronic implantable penile
prosthesis.
BACKGROUND
[0004] One treatment for male erectile dysfunction is the implantation
of a
penile prosthesis that erects the penis. Some existing penile prosthesis
include
inflatable cylinders or members that can be inflated or deflated using a pump
mechanism. The pump mechanism includes a pump, implantable in the scrotum,
that
can be manually squeezed by the user to move fluid from a reservoir into the
cylinders, creating an erection. For some patients, the manual pumping
procedure
may be relatively challenging.
SUMMARY
[0005] According to an aspect, an inflatable penile prosthesis includes
a fluid
reservoir configured to hold fluid, an inflatable member, and an electronic
pump
assembly configured to transfer the fluid between the fluid reservoir and the
inflatable
member. The electronic pump assembly includes a pump, an active valve disposed
in
parallel with the pump, and a controller configured to control the pump and
the active
valve.
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[0006] According to some aspects, the inflatable penile prosthesis may
include
one or more of the following features (or any combination thereof). The pump
may
include an electromagnetic pump. The pump may include a piezoelectric pump.
The
electronic pump assembly may include an antenna configured to receive a
wireless
control signal from an external device. The controller is configured to
control at least
one of the pump or the active valve based on the wireless control signal. In
some
examples, the pump is a first pump, and the electronic pump assembly includes
a
second pump. The second pump may be disposed in parallel with the first pump.
The
second pump may be configured to operate out of phase from the first pump. The
second pump may be disposed in series with the first pump. The pump may
include
one or more passive check valves.
[0007] According to an aspect, an inflatable penile prosthesis includes
a fluid
reservoir configured to hold fluid, an inflatable member, and an electronic
pump
assembly configured to transfer the fluid between the fluid reservoir and the
inflatable
member. The electronic pump assembly includes a first pump, a second pump, an
active valve, and a controller configured to control the first pump, the
second pump,
and the active valve.
[0008] According to some aspects, the inflatable penile prosthesis may
include
any of the above/below features (or any combination thereof). The first pump
and the
active valve may be in parallel with each other. The active valve is
configured to
transition between an open position in which the fluid flows through the
active valve
and a closed position in which the fluid is prevented from flowing through the
active
valve. The electronic pump assembly may include a pressure sensor, where the
controller is configured to control at least one of the first pump, the second
pump, or
the active valve based on a pressure measured by the pressure sensor. The
pressure
sensor may be connected to the inflatable member. The pressure sensor may be
connected to the fluid reservoir. The active valve may be a first active
valve, and the
electronic pump assembly may include a second active valve. The second active
valve may be disposed in series with the first pump. The electronic pump
assembly
may include a hermetic enclosure, where the hermetic enclosure includes a
hermetic
fluid chamber. The hermetic fluid chamber includes the first pump, the second
pump,
and the active valve. The controller being included within the hermetic
enclosure but
outside of the hermetic fluid chamber.
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[0009] According to an aspect, a method of operating an inflatable
penile
prosthesis includes receiving, by an antenna of an electronic pump assembly, a
wireless control signal from an external device, generating, by a controller,
a first
control signal to control an active valve of the electronic pump assembly,
generating,
by the controller, a second control signal to control a pump of the electronic
pump
assembly, actuating, in response to the first control signal, the active valve
to a closed
position, and actuating, in response to the second control signal, the pump to
transfer
fluid from a fluid reservoir to an inflatable member until a pressure in the
inflatable
member reaches a threshold level. In some examples, the method includes
generating, by the controller, a third control signal to control the active
valve and
actuating, in response to the third control signal, the active valve to an
open position
to transfer at least a portion of the fluid from the inflatable member to the
fluid
reservoir.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 illustrates an inflatable penile prosthesis having an
electronic
pump assembly according to an aspect.
[0011] FIG. 2A illustrates an inflatable penile prosthesis having an
electronic
pump assembly according to another aspect.
[0012] FIG. 2B illustrates an example of a hermetic fluid chamber of the
electronic pump assembly according to an aspect.
[0013] FIG. 3 illustrates an example of an electronic pump assembly
according to an aspect.
[0014] FIG. 4 illustrates an inflatable penile prosthesis having an
electronic
pump assembly according to another aspect.
[0015] FIG. 5 illustrates a flow chart depicting example operations of
an
electronic pump assembly according to an aspect.
DETAILED DESCRIPTION
[0016] This disclosure relates to an inflatable penile prosthesis that
includes
an electronic pump assembly to transfer fluid between a fluid reservoir and an
inflatable member. The electronic pump assembly may wirelessly communicate
with
an external device (e.g., a computer, a smartphone, tablet, pendant, key fob,
etc.) to
control the inflatable penile prosthesis (e.g., inflate or deflate the
inflatable member,
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update one or more control parameters). In some examples, the electronic pump
assembly includes a primary battery (e.g., a non-rechargeable battery). In
some
examples, the electronic pump assembly includes a rechargeable battery
configured to
be recharged by an external charger.
[0017] The
electronic pump assembly includes one or more pumps (e.g.,
electronically-controlled pumps such as one or more electromagnetic or
Piezoelectric
pumps), one or more active valves, and a controller. The controller may
actuate the
pump(s) and the active valve(s) to control the inflation and deflation of the
inflatable
member based on control signals transmitted to the pump(s) and the active
valve(s).
The pump(s) may be unidirectional or bidirectional. In some examples, the
electronic
pump assembly includes one or more pumps in parallel with an active valve. In
some
examples, the pump(s) can transfer the fluid to the inflatable member during
an
inflation cycle, and the active valve may transition to an open position to
permit fluid
to transfer back to the fluid reservoir during a deflation cycle. The pump(s)
may
transfer fluid on demand to the inflatable member at a relatively high-
pressure rate.
In some examples, the electronic pump assembly includes two or more parallel
pumps
such as a first pump and a second pump, where the first pump and the second
pump
are configured to operate out of phase from each other, which can increase the
efficiency of the pumping operations. In some examples, the use of parallel
pumps
that operate out of phase from each other may allow the pumps to operate at
lower
frequencies, which can reduce power and improve battery life. In some
examples, the
electronic pump assembly may include one or more pumps in series with a pump,
which can increase the amount of fluid that can be transferred to the
inflatable
member during a period of time.
[0018] An
individual pump may include one or more passive check valves
which transition to a closed position in response to positive pressure between
the
inflatable member and the fluid reservoir. In some examples, an active valve
may
transition to a closed position to hold (e.g., substantially hold) the
pressure in the
inflatable member. In some examples, the active valve may transition to an
open
position to release pressure in the inflatable member and/or allow a flowback
to the
inflatable member. In some examples, the electronic pump assembly includes a
single
active valve. In some examples, the electronic pump assembly includes multiple
active valves. For example, one or more active valves may be in series with a
pump.
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[0019] The electronic pump assembly may include a pressure sensor
configured to sense a pressure of the inflatable penile prosthesis. In some
examples,
the pressure sensor is coupled to the inflatable member. The pressure sensor
may
measure the pressure in the inflatable member. The controller may receive the
measured pressure from the pressure sensor and automatically control the
active
valve(s) and/or pump(s) to regulate the pressure in the inflatable member. In
some
examples, the pressure sensor is connected to the fluid reservoir. In some
examples,
the pressure sensor may detect intra-abdominal pressure (which can increase
during
activities such as exercise), and the controller can control the active
valve(s) and
pump(s) to minimize or prevent accidental inflations.
[0020] FIG. 1 illustrates an inflatable penile prosthesis 100 having an
electronic pump assembly 106 that can improve inflation and/or deflation
operations
of the prosthesis's inflatable member 104 according to an aspect. The
inflatable
penile prosthesis 100 includes a fluid reservoir 102, an inflatable member
104, and an
electronic pump assembly 106 configured to transfer fluid between the fluid
reservoir
102 and the inflatable member 104. The inflatable member 104 may be implanted
into the corpus cavernosum of the user, and the fluid reservoir 102 may be
implanted
in the abdomen or pelvic cavity of the user (e.g., the fluid reservoir 102 may
be
implanted in the lower portion of the user's abdominal cavity or the upper
portion of
the user's pelvic cavity). In some examples, at least a portion of the
electronic pump
assembly 106 may be implemented in the patient's body.
[0021] The inflatable member 104 may be capable of expanding upon the
injection of fluid into a cavity of the inflatable member 104. For instance,
upon
injection of the fluid into the inflatable member 104, the inflatable member
104 may
increase its length and/or width, as well as increase its rigidity. In some
examples, the
inflatable member 104 may include a pair of inflatable cylinders or at least
two
cylinders, e.g., a first cylinder member and a second cylinder member. The
volumetric capacity of the inflatable member 104 may depend on the size of the
inflatable cylinders. In some examples, the volume of fluid in each cylinder
may vary
from about 10 milliliters in smaller cylinders and to about 70 milliliters in
larger sizes.
In some examples, the first cylinder member may be larger than the second
cylinder
member. In other examples, the first cylinder member may have the same size as
the
second cylinder member.
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[0022] The fluid reservoir 102 may include a container having an
internal
chamber configured to hold or house fluid that is used to inflate the
inflatable member
104. The volumetric capacity of the fluid reservoir 102 may vary depending on
the
size of the inflatable penile prosthesis 100. In some examples, the volumetric
capacity of the fluid reservoir 102 may be 3 to 150 cubic centimeters. In some
examples, the fluid reservoir 102 is constructed from the same material as the
inflatable member 104. In other examples, the fluid reservoir 102 is
constructed from
a different material than the inflatable member 104. In some examples, the
fluid
reservoir 102 contains a larger volume of fluid than the inflatable member
104.
[0023] The inflatable penile prosthesis 100 may include a first conduit
connector 103 and a second conduit connector 105. Each of the first conduit
connector 103 and the second conduit connector 105 may define a lumen
configured
to transfer the fluid to and from the pump assembly 106. The first conduit
connector
103 may be coupled to the electronic pump assembly 106 and the fluid reservoir
102
such that fluid can be transferred between the electronic pump assembly 106
and the
fluid reservoir 102 via the first conduit connector 103. For example, the
first conduit
connector 103 may define a first lumen configured to transfer fluid between
the
electronic pump assembly 106 and the fluid reservoir 102. The first conduit
connector 103 may include a single or multiple tube members for transferring
the
fluid between the electronic pump assembly 106 and the fluid reservoir 102.
[0024] The second conduit connector 105 may be coupled to the pump
assembly 106 and the inflatable member 104 such that fluid can be transferred
between the electronic pump assembly 106 and the inflatable member 104 via the
second conduit connector 105. For example, the second conduit connector 105
may
define a second lumen configured to transfer fluid between the electronic pump
assembly 106 and the inflatable member 104. The second conduit connector 105
may
include a single or multiple tube members for transferring the fluid between
the
electronic pump assembly 106 and the inflatable member 104. In some examples,
the
first conduit connector 103 and the second conduit connector 105 may include a
silicone rubber material. In some examples, the electronic pump assembly 106
may
be directly connected to the fluid reservoir 102.
[0025] The electronic pump assembly 106 may automatically transfer fluid
between the fluid reservoir 102 and the inflatable member 104 without the user
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manually operating a pump (e.g., squeezing and releasing a pump bulb). The
electronic pump assembly 106 includes one or more pumps 120, one or more
active
valves 118, a controller 114 configured to control the pump(s) 120 and the
active
valve 118, and one or more pressure sensors 130. For example, the controller
114
may control the pump(s) 120 to pump fluid between the fluid reservoir 102 and
the
inflatable member 104. The controller 114 may control the active valve 118 to
transition between an open position and a closed position. The pump(s) 120 is
configured to transfer fluid (on demand) to the inflatable member 104 at
relatively
high-pressure (e.g., up to approximately twenty pounds per square inch (PSI)).
[0026] The electronic pump assembly 106 may include a battery 116
configured to provide power to the controller 114 and other components on the
electronic pump assembly 106. In some examples, the battery 116 is a non-
rechargeable battery. In some examples, the battery 116 is a rechargeable
battery. In
some examples, the electronic pump assembly 106 (or a portion thereof) (or the
controller 114) is configured to be connected to an external charger to charge
the
battery 116. In some examples, the electronic pump assembly 106 may define a
charging interface that is configured to connect to the external charger. In
some
examples, the charging interface includes a universal serial bus (USB)
interface
configured to receive a USB charger. In some examples, the charging technology
may be electromagnetic or Piezoelectric.
[0027] The electronic pump assembly 106 may include an antenna 112
configured to wirelessly transmit (and receive) wireless signals 109 from an
external
device 101. The external device 101 may be any type of component that can
communicate with the electronic pump assembly 106. The external device 101 may
be a computer, smartphone, tablet, pendant, key fob, etc. A user may use the
external
device 101 to control the inflatable penile prosthesis 100. In some examples,
the user
may use the external device 101 to inflate or deflate the inflatable member
104. For
example, in response to the user activating an inflation cycle using the
external device
101 (e.g., selecting a user control on the external device 101), the external
device 101
may transmit a wireless signal 109 to the electronic pump assembly 106 to
initiate the
inflation cycle (received via the antenna 112), where the controller 114 may
control
the active valve(s) 118 and the pump(s) 120 to inflate the inflatable member
104 to a
target inflation pressure. In some examples, the controller 114 may cause the
active
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valve to a closed position and cause the pump(s) to operate to move fluid from
the
fluid reservoir 102 to the inflatable member 104.
[0028] In some examples, in response to the user activating a deflation
cycle
using the external device 101 (e.g., selecting a user control on the external
device
101), the external device 101 may transmit a wireless signal 109 to the
electronic
pump assembly 106 to initiate the deflation cycle (received via the antenna
112),
where the controller 114 may control the active valve(s) 118 (and, in some
examples,
the pump(s) 120) to transfer fluid from the inflatable member 104 to the fluid
reservoir 102. For example, the controller 114 may control the active valve
118 to
move to the open position to allow fluid to transfer from the inflatable
member 104 to
the fluid reservoir 102. In some examples, the controller 114 may control one
or
more pumps 120 to further move the fluid from the inflatable member 104 to the
fluid
reservoir 102 during the deflation cycle. In some examples, during the
deflation
cycle, fluid is transferred back until the pressure in the inflatable member
104 reaches
a partial inflation pressure. In some examples, the controller 114 may
automatically
determine to initiate a deflation cycle, which causes the controller 114 to
control the
active valve(s) 118 (and, in some examples, the pump(s) 120) to transfer fluid
back to
the fluid reservoir 102.
[0029] The controller 114 may be any type of controller configured to
control
operations of the pump(s) 120 and the active valve(s) 118. In some examples,
the
controller 114 is a microcontroller. In some examples, the controller 114
includes one
or more drivers configured to drive the pump(s) 120 and the active valve(s)
118. In
some examples, the driver(s) are components separate from the controller 114.
The
controller 114 may be communicatively coupled to the active valve(s) 118, the
pump(s) 120, and the pressure sensor(s) 130. In some examples, the controller
114 is
connected to the active valve(s) 118, the pump(s) 120, and the pressure
sensor(s) 130
via wired data lines. The controller 114 may include a processor 113 and a
memory
device 115. The processor 113 may be formed in a substrate configured to
execute
one or more machine executable instructions or pieces of software, firmware,
or a
combination thereof The processor 113 can be semiconductor-based ¨ that is,
the
processors can include semiconductor material that can perform digital logic.
The
memory device 115 may store information in a format that can be read and/or
executed by the processor 113. The memory device 115 may store executable
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instructions that when executed by the processor 113 cause the processor 113
to
perform certain operations discussed herein. The controller 114 may receive
data via
the pressure sensor(s) 130 and/or the external device 101 and control the
active
valve(s) 118 and/or the pump(s) 120 by transmitting control signals to the
active
valve(s) 118 and/or the pump(s) 120.
[0030] The memory device 115 may store control parameters that can be
set
or modified by the user and/or physician using the external device 101. In
some
examples, the control parameters may include the target inflation pressure
and/or the
partial inflation pressure. In some examples, the target inflation pressure is
a
maximum (or desired) pressure allowable in the inflatable member 104. In some
examples, the partial inflation pressure is a pressure threshold that can more
closely
mimic the natural experience and/or personal comfort of the user. A user or
physician
may update the control parameters using the external device 101, which can be
communicated to the controller 114 via the antenna 112 and then updated in the
memory device 115.
[0031] The external device 101 may communicate with the electronic pump
assembly 106 over a network. In some examples, the network includes a short-
range
wireless network such as near field communication (NFC), Bluetooth, or
infrared
communication. In some examples, the network may include the Internet (e.g.,
Wi-
Fi) and/or other types of data networks, such as a local area network (LAN), a
wide
area network (WAN), a cellular network, satellite network, or other types of
data
networks.
[0032] In some examples, the electronic pump assembly 106 includes a
single
pump 120 such as a pump 120-1. The pump 120-1 may be disposed in parallel with
the active valve 118. In some examples, the electronic pump assembly 106
includes
multiple pumps 120. For example, the pumps 120 include pump 120-1 and pump
120-2. In some examples, the pump 120-1 is disposed in a fluid passageway 125
that
is used to fill the inflatable member 104 (e.g., during the inflation cycle).
In some
examples, the pump 120-2 is disposed in a fluid passageway 127 that is used to
fill the
inflatable member 104 (e.g., during the inflation cycle). In some examples,
the pump
120-2 is disposed in parallel with the pump 120-1. The pump 120-1 may transfer
fluid according to a first flow rate, and the pump 120-1 may transfer fluid
according
to a second flow rate. In some examples, the first flow rate is substantially
the same
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as the second flow rate. In some examples, the first flow rate is different
from the
second flow rate.
[0033] In some examples, the pumps 120 may include more than two pumps
120 such as three, four, five, six, or greater than six pumps 120. For
example, the
pumps 120 may include a third pump in parallel with the pump 120-2, a fourth
pump
in parallel with the third pump, and so forth. In some examples, the pumps 120
may
include one or more pumps 120 in series with one or more other pumps 120. For
example, one or more pumps 120 may be in series with the pump 120-1. In some
examples, one or more pumps 120 may be in series with the pump 120-2.
[0034] Each pump 120 is an electronically-controlled pump. Each pump 120
may be electronically-controlled by the controller 114. For example, each pump
120
may be connected to the controller 114 and may receive a signal to actuate a
respective pump 120. A pump 120 may be unidirectional in which the pump 120
can
transfer fluid from the fluid reservoir 102 to the inflatable member 104 (or
from the
inflatable member 104 to the fluid reservoir 102). In some examples, a pump
120 is
bidirectional in which the pump 120 can transfer fluid from the fluid
reservoir 102 to
the inflatable member 104 and from the inflatable member 104 to the fluid
reservoir
102. In some examples, the pumps 120 are either unidirectional or
bidirectional. In
some examples, the pumps 120 include a combination of one or more
unidirectional
pumps and one or more bidirectional pumps.
[0035] In some examples, the pump 120 is an electromagnetic pump that
moves the fluid between the fluid reservoir 102 and the inflatable member 104
using
electromagnetism. With respect to an electromagnetic pump, a magnetic fluid is
set at
angles to the direction the fluid moves in, and a current is passed through
it.
[0036] In some examples, the pump 120 is a piezoelectric pump. In some
examples, a piezoelectric pump may be a diaphragm micropump that uses
actuation of
a diaphragm to drive a fluid. In some examples, a piezoelectric pump may
include
one or more piezo pumps (e.g., piezo elements), which may be implemented by a
substrate layer (e.g., a single substrate layer) of high-voltage piezo
elements or may
be implemented by multiple substrate layers (e.g., stacked substrate layers)
of low-
voltage piezo elements. In some examples, the pump 120 includes a plurality of
micro-pumps (e.g., piezoelectrically-driven micro-pumps) disposed on one or
more
substrates (e.g., wafer(s)). In some examples, the micro-pumps include a
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based material. In some examples, the micro-pumps include a metal (e.g.,
steel)
based material. In some examples, the pump 120 is non-mechanical (e.g.,
without
moving parts).
[0037] In some examples, in the case of multiple pumps 120, each pump
120
may be a pump of the same type (e.g., all pumps 120 are electromagnetic pumps
or all
pumps 120 are piezoelectric pumps). In some examples, one or more pumps 120
are
different from one or more other pumps 120. For example, pumps 120 may include
different types of piezoelectric pumps or the pumps 120 may include different
types
of electromagnetic pumps. The pump 120-1 may be a piezoelectric pump having a
first number of micro-pumps, and the pump 120-2 may be a piezoelectric pump
having a second number of micro-pumps (where the second number is different
from
the first number). The pump 120-1 may be an electromagnetic pump, and the pump
120-2 may be a piezoelectric pump.
[0038] A pump 120 may include one or more passive check valves. The
passive check valve(s) may assist with maintaining pressure in the inflatable
member
104. In some examples, a pump 120 may include a single passive check valve. In
some examples, the pump 120 may include multiple passive check valves such as
two
passive check values or more than two passive check valves. The passive check
valve(s) of a respective pump 120 may not be directly controlled by the
controller
114, but rather based on the pressure between the inflatable member 104 and
the fluid
reservoir 102. The passive check valve(s) may transition between an open
position
(in which fluid is permitted to flow through the passive check valve(s)) and a
closed
position (in which fluid is prevented from flowing through the passive check
valve(s)). In some examples, the passive check valve(s) transitions to the
closed
position in response to positive pressure between the inflatable member 104
and the
fluid reservoir 102. In some examples, the passive check valve(s) transition
to the
open position in response to negative pressure between the inflatable member
104 and
the fluid reservoir 102.
[0039] In some examples, the use of two parallel pumps (e.g., pump 120-
1,
pump 120-2) (or more than two parallel pumps 120) may increase the amount of
fluid
that can be transferred to the inflatable member 104. In some examples, the
pumps
120 may operate out of phase from each other in order to increase the
efficiency of the
electronic pump assembly 106. Two parallel pumps (e.g., pump 120-1, pump 120-
2)
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operating at out of phase (e.g., 180 degrees of out of phase) from each other
may
allow the output pressure of the pump 120-1 to improve the valve closure of
the pump
120-2, thereby improving the overall performance (and vice versa). The use of
parallel pumps 120 operating out of phase from each other may allow the pumps
120
to operate at lower frequencies, which can reduce power (thereby extending
battery
life). Furthermore, a smoother flow rate may also be achieved resulting in
less
vibration and an improved patient experience. As indicated above, one or more
pumps 120 may be in series with one or more parallel pumps 120. For example,
an
additional pump 120 may be in series with the pump 120-1, and/or an additional
pump 120 may be in series with the pump 120-2. Serial pump operation may
enable
doubling of the pressure when two similar-performing pumps 120 are utilized.
In
some examples, two or more serially-disposed pumps 120 may be operated at the
same phase.
[0040] Out of phase may refer to two or more control signals whose phase
relationship with each other is such that one control signal is at its
positive peak while
the other control signal is at (or near) its negative peak. The pump 120-1 may
operate
according to a first control signal (generated by the controller 114), and the
pump
120-2 may operate according to a second control signal (generated by the
controller
114). The first and second control signals may control the pump 120-1 and the
pump
120-2, respectively, to operate out of phase from one another. Each of the
first
control signal and the second control signal may define a series of activation
states,
e.g., a first state and a second state. For example, each of the first control
signal and
the second control signal may include a waveform having a series of first
states (one
of high states or low states) and second states (one of low states or high
states). The
first state may indicate that a diaphragm element moves in a first direction,
and the
second state may indicate that the diaphragm element moves in a second
direction
(opposite to the first direction). The first signal may indicate the first
state during a
first period of time, followed by the second state during a second period of
time,
followed by the first state during a third period of time, followed by the
second state
during a fourth period of time, and so forth. The second signal may indicate
the
second state during the first period of time, followed by the first state
during the
second period time, the second state during the third period of time, the
first state
during the fourth period of time, and so forth.
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[0041] The active valve 118 may be an electronically-controlled valve.
The
active valve 118 may be electronically-controlled by the controller 114. For
example,
the active valve 118 may be connected to the controller 114 and may receive a
signal
to transition the active valve 118 between an open position in which the fluid
flows
through the active valve 118 and a closed position in which the fluid is
prevented
from flowing through the active valve 118. In some examples, the active valve
118 is
disposed in a fluid passageway 124 that is used to empty the inflatable member
104
(e.g., in the deflation cycle). In some examples, the active valve 118 may
transition to
the closed position to hold (e.g., substantially hold) the pressure in the
inflatable
member 104. In some examples, the active valve 118 may transition to the open
position to transfer fluid back to the fluid reservoir 102, release pressure
in the
inflatable member 104 and/or allow a flow back to the inflatable member 104.
In
some examples, the active valve 118 may be used to hold (e.g., substantially
hold) the
partial inflation pressure.
[0042] In some examples, the electronic pump assembly 106 includes a
single
active valve 118. In some examples, the electronic pump assembly 106 includes
multiple active valves 118. In some examples, one or more additional active
valves
118 may be in series with the pump 120-1 and/or the pump 120-2. In some
examples,
an additional active valve 118 (e.g., a series active valve 118) may be
disposed in a
fluid pathway portion 117 that is connected to the fluid reservoir 102. In
some
examples, an additional active valve 118 (e.g., a series active valve 118) may
be
disposed in a fluid pathway portion 119 that is connected to the inflatable
member
104. These additional active valves 118 may reduce leakage when at maximum
inflation pressure or at partial inflation pressure.
[0043] The electronic pump assembly 106 may include one or more pressure
sensors 130 configured to sense a pressure of the inflatable penile prosthesis
100. In
some examples, the electronic pump assembly 106 includes a single pressure
sensor
130. In some examples, the electronic pump assembly 106 may include multiple
pressure sensors 130. For example, the pressure sensors 130 may include a
pressure
sensor 130 configured to measure the pressure of the inflatable member and/or
a
pressure sensor 130 configured to measure the pressure of the fluid reservoir
102. In
some examples, the electronic pump assembly 106 may include additional
pressure
sensors 130, which can be located at various positions in the electronic pump
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assembly 106. For example, a pressure sensor 130 may be disposed between
active
valves 118. In some examples, a pressure sensor 130 may be disposed between
two
pumps 120 connected in series. In some examples, a pressure sensor 130 may be
disposed between two pumps 120 connected in parallel. In some examples, a
pressure
sensor 130 may be disposed between an active valve 118 and a pump 120. The
pressure sensor(s) 130 are communicatively coupled to the controller 114 such
that
the controller 114 can receive signals from the pressure sensor 130. In
some
examples, a pressure sensor 130 is configured to sense the amount of fluid
transferred
to the inflatable member 104 and send one or more signals to the controller
114 that
indicate the amount of fluid that has been transferred.
[0044] In some
examples, the pressure sensor 130 is disposed between the
pump(s) 120 and the inflatable member 104, as shown in FIG. 1. The pressure
sensor
130 may measure the pressure in the inflatable member 104. The controller 114
may
receive the measured pressure from the pressure sensor 130 and automatically
control
the active valve(s) 118 and/or pump(s) 120 to regulate the pressure. For
example, if
the measured pressure is greater than the target inflation pressure, the
controller 114
may transition the active valve 118 to the open position (to allow fluid to
transfer
back to fluid reservoir 102), when the measured pressure achieves the target
inflation
pressure, the controller 114 may transition the active valve 118 to the closed
position
to maintain the pressure in the inflatable member 104. In some examples, a
pressure
sensor 130 is disposed between the pump(s) 120 and the fluid reservoir 102. In
some
examples, the pressure sensor 130 may detect intra-abdominal pressure (which
can
increase during activities such as exercise), and the controller 114 can
control the
active valve(s) 118 and the pump(s) to minimize or prevent accidental
inflations.
[0045] In some
examples, a pressure sensor 130 is included within the
inflatable member 104. In some examples, the pressure sensor 130 is integrated
into a
wall of a cylinder of the inflatable member 104. In some examples, when the
pressure
sensor 130 is integrated in the wall of the cylinder, the pressure sensor 130
may
monitor the condition of the cylinder material, and the pressure sensor 130
can
monitor the changing of the cylinder material to a point where the cylinder
might have
to be replaced. In this case, the controller 114 may send information, over a
network,
to an external device 101 on a regular basis for potential checkups.
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[0046] In some examples, the pressure sensor 130 is configured to sense
the
pressure level and send one or more signals to the controller 114 that
indicate the
pressure level in the inflatable member 104, the fluid reservoir 102, and/or
other
locations of the inflatable penile prosthesis 100. In some examples, the
pressure
sensor 130 is configured to monitor the flow rate (e.g., the flow rate in both
directions). The controller 114 may control the activation (and deactivation)
of the
pump(s) 120 and/or the active valve(s) 118 based on the signals received from
the
pressure sensor(s) 130.
[0047] In some examples, the electronic pump assembly 106 includes a
hermetic enclosure 108 that encloses the components of the electronic pump
assembly
106. A hermetic enclosure 108 may be an air-tight (or substantially air-tight)
container. The hermetic enclosure 108 may include one or more metal-based
materials. In some examples, the hermetic enclosure 108 is a Titanium
container. In
some examples, the only material in contact with the patient is Titanium. In
some
examples, the hermetic enclosure 108 includes one or more non-metal-based
materials
(e.g., ceramic). In some examples, a portion of the hermetic enclosure 108 is
a metal-
based material and a portion of the hermetic enclosure 108 is a non-metal-
based
material. In some examples, the hermetic enclosure 108 defines a feedthrough
(e.g., a
hermetic feedthrough, an electrical feedthrough, a feedthrough connector,
etc.) to
receive/transmit wireless signals from/to the external device 101. In some
examples,
the feedthrough includes a metal-based material and an insulator-based
material (e.g.,
ceramic).
[0048] In some examples, the electronic pump assembly 106 includes a
hermetic fluid chamber 110 disposed inside of the hermetic enclosure 108. The
hermetic fluid chamber 110 may be a separate air-tight (or substantially air-
tight)
container that is within the hermetic enclosure 108. The hermetic fluid
chamber 110
may include one or more metal-based materials. In some examples, the hermetic
fluid
chamber 110 is a Titanium container. The hermetic fluid chamber 110 may
isolate
the fluid from the electronics (e.g., the controller 114, the battery 116,
etc.). In other
words, the electronics section may be isolated (e.g., completely isolated)
from the
fluid via the hermetic fluid chamber 110. The hermetic fluid chamber 110 may
be
fluidly connected to the fluid reservoir 102 and the inflatable member 104.
The
hermetic fluid chamber 110 may include the active valve(s) 118, the pump(s)
120, and
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the pressure sensor(s) 130. In some examples, the hermetic fluid chamber 110
defines
a feedthrough (e.g., a hermetic feedthrough, an electrical feedthrough, a
feedthrough
connector, etc.) to the controller 114 to receive/transmit signals from/to the
controller
114. In some examples, the hermetic fluid chamber 110 disposed within the
hermetic
enclosure 108 creates a double hermetic system. In some examples, the
electronic
pump assembly 106 includes only one hermetic enclosure (e.g., the hermetic
enclosure 108).
[0049] FIG. 2A illustrates an inflatable penile prosthesis 200 having an
electronic pump assembly 206 according to an aspect. FIG. 2B illustrates an
example
of a hermetic fluid chamber 210 of the electronic pump assembly 206 according
to an
aspect. The inflatable penile prosthesis 200 of FIGS. 2A and 2B may be an
example
of the inflatable penile prosthesis 100 of FIG. 1 and may include any of the
details
discussed with reference to FIG. 1.
[0050] The inflatable penile prosthesis 200 includes a fluid reservoir
202, an
inflatable member 204, and an electronic pump assembly 206 configured to
transfer
fluid between the fluid reservoir 202 and the inflatable member 204. The
electronic
pump assembly 206 may automatically transfer fluid between the fluid reservoir
202
and the inflatable member 204 without the user manually operating a pump
(e.g.,
squeezing and releasing a pump bulb). The electronic pump assembly 206
includes a
hermetic enclosure 208 that encloses the components of the electronic pump
assembly
206. A hermetic enclosure 208 may be an air-tight (or substantially air-tight)
metal-
based container. In some examples, the hermetic enclosure 208 is a Titanium
container. In some examples, the only material in contact with the patient is
Titanium.
[0051] The electronic pump assembly 206 includes an active valve 218, a
pump 220-1, a pump 220-2, a pressure sensor 230, a driver 236 to drive the
active
valve 218, the pump 220-1, and the pump 220-2, and a battery 216 to power the
controller 214 (and other electrical components). In some examples, the
battery 216
is a non-rechargeable battery. In some examples, the battery 216 is a
rechargeable
battery. In some examples, the electronic pump assembly 206 (or a portion
thereof) is
configured to be connected to an external charger 234 to charge the battery
216. In
some examples, the controller 214 may include a charging interface 232 that is
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configured to connect to the external charger 234. In some examples, the
charging
technology may be electromagnetic or Piezoelectric.
[0052] The electronic pump assembly 206 may include an antenna 212
configured to wirelessly transmit (and receive) wireless signals from an
external
device 201. In some examples, the external device 201 is a smartphone, as
shown in
FIG. 2A. However, the external device 201 may be any type of component that
can
communicate with the electronic pump assembly 206 such as a computer (laptop
or
desktop), a tablet, a pendant, a key fob, etc. A user may use the external
device 201
to control the inflatable penile prosthesis 200. The electronic pump assembly
206
may include a feedthrough 240 through the hermetic enclosure 208 to
receive/transmit
wireless signal via the antenna 212. For example, the antenna 212 may be
connected
(e.g., via one or more wired connection lines) to the controller 214 in which
the wired
connection line(s) extend through the feedthrough 240. The external device 201
may
communicate with the controller 214 over a network. In some examples, the
network
includes a short-range wireless network such as near field communication
(NFC),
Bluetooth, or infrared communication. In some examples, the network may
include
the Internet (e.g., Wi-Fi) and/or other types of data networks, such as a
local area
network (LAN), a wide area network (WAN), a cellular network, satellite
network, or
other types of data networks.
[0053] The controller 214 may be any type of controller configured to
control
operations of the pump 220-1, the pump 220-2, and the active valve 218. In
some
examples, the electronic pump assembly 206 includes one or more drivers 236
configured to drive the pump 220-1, the pump 220-2, and the active valve 218
based
on control signals generated by the controller 214.
[0054] The electronic pump assembly 206 may include a hermetic fluid
chamber 210 disposed inside of the hermetic enclosure 208. The hermetic fluid
chamber 210 may be a separate air-tight (or substantially air-tight) container
that is
within the hermetic enclosure 208. The hermetic fluid chamber 210 may include
one
or more metal-based materials. In some examples, the hermetic fluid chamber
210 is
a Titanium container. The hermetic fluid chamber 210 may isolate the fluid
from the
electronics (e.g., the controller 214, the driver(s) 236, the battery 216,
etc.). In other
words, the electronics section may be completely isolated from the fluid via
the
hermetic fluid chamber 210. The hermetic fluid chamber 210 may be fluidly
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connected to the fluid reservoir 202 and the inflatable member 204. The
hermetic
fluid chamber 210 may include the active valve 218, the pump 220-1, the pump
220-
1, and the pressure sensor 230.
[0055] The hermetic fluid chamber 210 defines a feedthrough 238 (e.g., a
hermetic feedthrough, an electrical feedthrough, a feedthrough connector,
etc.) to the
driver(s) 236 and/or the controller 214 to exchange signals between the
controller
214, the driver 236, and the components included within the hermetic fluid
chamber
210 such as the active valve 218, the pump 220-1, the pump 220-2, and the
pressure
sensor 230. In some examples, the driver(s) 236 (and/or the controller 214)
are
connected to the active valve 218, the pump 220-1, the pump 220-2, and the
pressure
sensor 230 via one or more wired connection lines, where the wired connection
lines
extend through the feedthrough 238. In some examples, the hermetic fluid
chamber
210 disposed within the hermetic enclosure 208 creates a double hermetic
system. In
some examples, the electronic pump assembly 206 includes only one hermetic
enclosure (e.g., the hermetic enclosure 208).
[0056] The pump 220-1 may include an inlet and an outlet. The inlet of
the
pump 220-1 may be fluidly connected to the fluid reservoir 202, and the outlet
of the
pump 220-1 may be fluidly connected to the inflatable member 204. The pump 220-
1
may include an inlet and an outlet. The inlet of the pump 220-2 may be fluidly
connected to the fluid reservoir 202, and the outlet of the pump 220-2 may be
fluidly
connected to the inflatable member 204. The active valve 218 may include an
inlet
and an outlet. The inlet of the active valve 218 may be fluidly connected to
the
inflatable member 204 and the outlet of the active valve 218 may be fluidly
connected
to the fluid reservoir 202.
[0057] The pump 220-1 and the pump 220-2 are electronically-controlled
pumps. The pump 220-1 and the pump 220-2 may be electronically-controlled by
the
controller 214. For example, each of the pump 220-1 and the pump 220-2 may be
connected to the driver(s) 236 and/or the controller 214 to receive control
(driving)
signals. In some examples, the pump 220-1 and the pump 220-2 are
unidirectional in
which the pump 220-1 and the pump 220-2 can transfer fluid from the fluid
reservoir
202 to the inflatable member 204. However, in some examples, the pump 220-1
and
the pump 220-2 are bidirectional. In some examples, the pump 220-1 or the pump
220-2 is an electromagnetic pump that moves the fluid between the fluid
reservoir 202
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and the inflatable member 204 using electromagnetism. With respect to an
electromagnetic pump, a magnetic fluid is set at angles to the direction the
fluid
moves in, and a current is passed through it.
[0058] In some examples, the pump 220-1 or the pump 220-2 is a
piezoelectric pump. In some examples, a piezoelectric pump may be a diaphragm
micropump that uses actuation of a diaphragm to drive a fluid. In some
examples, a
piezoelectric pump may include one or more piezo pumps (e.g., piezo elements),
which may be implemented by a substrate layer (e.g., a single substrate layer)
of high-
voltage piezo elements or may be implemented by multiple substrate layers
(e.g.,
stacked substrate layers) of low-voltage piezo elements. In some examples, the
pump
220-1 or the pump 220-2 includes a plurality of micro-pumps (e.g.,
piezoelectrically-
driven micro-pumps) disposed on one or more substrates (e.g., wafer(s)). In
some
examples, the micro-pumps include a silicon-based material. In some examples,
the
micro-pumps include a metal (e.g., steel) based material. In some examples,
the
pump 220-1 or the pump 220-2 is non-mechanical (e.g., without moving parts).
[0059] The pump 220-1 or the pump 220-2 may include a passive check
valve
223 and a passive check valve 225. The passive check valve 223 and the passive
check valve 225 may assist with maintaining pressure in the inflatable member
204.
The pump 220-1 may be disposed in parallel with the active valve 218. The pump
220-2 may be disposed in parallel with the pump 220-1. In some examples, the
use of
two parallel pumps (e.g., pump 220-1, pump 220-2) may increase the amount of
fluid
that can be transferred to the inflatable member 204. In some examples, the
pump
220-1 and the pump 220-1 may operate out of phase from each other in order to
increase the efficiency of the electronic pump assembly 206. In some examples,
two
parallel pumps (e.g., pump 220-1, pump 220-2) operating out of phase (e.g.,
180
degrees of out of phase) from each other may allow the output pressure of the
pump
220-1 to improve the valve closure of the pump 220-2, thereby improving the
overall
performance (and vice versa). In some examples, the use of parallel pumps
(e.g.,
pump 220-1, pump 220-2) operating out of phase from each other may allow the
pump 220-1 and the pump 220-2 to operate at lower frequencies, which can
reduce
power (thereby extending battery life). Furthermore, a smoother flow rate may
also
be achieved resulting in less vibration and an improved patient experience.
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[0060] The active valve 218 may be an electronically-controlled valve.
The
active valve 218 may be electronically-controlled by the controller 214. For
example,
the active valve 218 may be connected to the driver(s) 236 (and/or the
controller 214)
and may receive a signal to transition the active valve 218 between an open
position
in which the fluid flows through the active valve 218 and a closed position in
which
the fluid is prevented from flowing through the active valve 218. In some
examples,
the active valve 218 may transition to the closed position to hold (e.g.,
substantially
hold) the pressure in the inflatable member 204. In some examples, the active
valve
218 may transition to the open position to transfer fluid back to the fluid
reservoir
202, release pressure in the inflatable member 204 and/or allow a flow back to
the
inflatable member 204. In some examples, the active valve 218 may be used to
hold
(e.g., substantially hold) the partial inflation pressure.
[0061] The pressure sensor 230 is configured to measure the pressure of
the
inflatable member 204. The pressure sensor 230 may be coupled to a portion of
the
fluid passageway connected to the inflatable member 204. In some examples, the
pressure sensor 230 may be coupled to a portion of the fluid passageway
between the
active valve 218 and the inflatable member 204. In some examples, the pressure
sensor 230 may be coupled to a portion of the fluid passageway between the
pump
220-1 and the inflatable member 204. In some examples, the pressure sensor 230
may
be coupled to a portion of the fluid passageway between the pump 220-2 and the
inflatable member 204. The pressure sensor 230 is communicatively coupled to
the
controller 214 such that the controller 214 can receive signals from the
pressure
sensor 230. The controller 214 may receive the measured pressure from the
pressure
sensor 230 and automatically control the active valve 218, the pump 220-1, and
the
pump 220-2. For example, if the measured pressure is less than the target
inflation
pressure, the controller 214 may actuate the pump 220-1 and the pump 220-2 to
pump
additional fluid to the inflatable member 204.
[0062] FIG. 3 illustrates an example of a portion of an electronic pump
assembly 306 according to an aspect. The electronic pump assembly 306 may be
an
example of the electronic pump assembly 106 of FIG. 1 and/or the electronic
pump
assembly 206 of FIGS. 2A and 2B and may include any of the details discussed
with
reference to the inflatable penile prosthesis 100 of FIG. 1 and/or the
inflatable penile
prosthesis 200 of FIGS. 2A and 2B.
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[0063] The electronic pump assembly 306 is configured to transfer fluid
between the fluid reservoir 302 and the inflatable member 304. The electronic
pump
assembly 306 may automatically transfer fluid between the fluid reservoir 302
and the
inflatable member 304 without the user manually operating a pump (e.g.,
squeezing
and releasing a pump bulb).
[0064] The electronic pump assembly 306 includes a pump 320-1 disposed
within a fluid passageway 327 (e.g., a fill passageway), and an active valve
318
disposed within a fluid passageway 324 (e.g., an empty passageway). The pump
320-
1 may be an electromagnetic pump or a Piezoelectric pump. The pump 320-1 may
include a passive check valve 323 and a passive check valve 325. The fluid
passageway 327 may be a fluid branch that is separate (and parallel) to the
fluid
passageway 324. The fluid passageway 327 is the passageway that transfers
fluid
from the fluid reservoir 302 to the inflatable member 304. The fluid
passageway 324
is the passageway that transfers fluid from the inflatable member 304 to the
fluid
reservoir 302. The pump 320-1 is disposed in parallel with the active valve
318.
[0065] In some examples, the electronic pump assembly 306 may include an
active valve 319 in series with the pump 320-1 (e.g., the pump 320-1 and the
active
valve 319 are disposed within the fluid passageway 327). In some examples, the
electronic pump assembly 306 may include a pump 320-2 in series with the
active
valve 318 (e.g., the pump 320-2 and the active valve 318 are disposed in the
fluid
passageway 324). The pump 320-2 may be an electromagnetic pump or a
Piezoelectric pump. The pump 320-2 may include a passive check valve 323 and a
passive check valve 325. In some examples, the electronic pump assembly 306
includes an active valve 348 that is fluidly connected to the fluid reservoir
302. The
active valve 348 may be in series with either the active valve 318 (and the
pump 320-
2) or the pump 320-1 (and the active valve 319). In some examples, the
electronic
pump assembly 306 includes an active valve 352 that is fluidly connected to
the
inflatable member 304. The active valve 352 may be in series with either the
active
valve 319 (and the pump 320-1) or the pump 320-2 (and the active valve 318).
[0066] The active valve 348, the pump 320-1, the active valve 318, the
active
valve 352, the active valve 318, and the pump 320-2 may be electronically
controlled
by a controller and/or driver (e.g., the controller 114 of FIG. 1, the
controller 214 and
the driver 236 of FIGS. 2A and 2B). The pump 320-1 and the pump 320-2 may be
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unidirectional or bidirectional. With respect to the fluid passageway 327, in
some
examples, the pump 320-1 and the active valve 319 may swap positions (e.g.,
where
the active valve 319 is in series between the active valve 348 and the pump
320-1).
With respect to the fluid passageway 324, in some examples, the active valve
318 and
the pump 320-2 may swap positions (e.g., where the pump 320-1 is in series
with and
between the active valve 318 and the active valve 348).
[0067] In some examples, one or more additional active valves and/or one
or
more additional pumps are disposed in series within the fluid passageway 327.
In
some examples, one or more additional active valves and/or one or more
additional
pumps are disposed in series within the fluid passageway 324. In some
examples, the
electronic pump assembly 306 may include one or more additional (and parallel)
fluid
passageways, where each additional (and parallel) fluid passageway may include
one
or more active valves and one or more pumps.
[0068] In some examples, the electronic pump assembly 306 may include a
pressure sensor 330 and a pressure sensor 331. The pressure sensor 330 and the
pressure sensor 331 are connected to a controller (e.g., the controller 114 of
FIG. 1,
the controller 214 of FIGS. 2A and 2B), where the controller receives the
measured
pressure from the pressure sensor 330 and the pressure sensor 331.
[0069] The pressure sensor 330 is configured to measure the pressure in
the
inflatable member 304. The controller may receive the measured pressure from
the
pressure sensor 330 and automatically control the active valves and/or the
pump to
regulate the pressure. In some examples, the pressure sensor 331 is configured
to
measure the pressure in the fluid reservoir 302. In some examples, the
pressure
sensor 331 may detect intra-abdominal pressure (which can increase during
activities
such as exercise, and the controller can control the active valves and pump to
minimize or prevent accidental inflations. In some examples, the electronic
pump
assembly 306 may include one or more pressure sensors at other locations
within the
electronic pump assembly 306. For example, a pressure sensor may be disposed
between the active valve 348 and the pump 320-1. In some examples, a pressure
sensor may be disposed between the pump 320-1 and the active valve 319. In
some
examples, a pressure sensor may be disposed between the active valve 348 and
the
active valve 318. In some examples, a pressure sensor may be disposed between
the
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active valve 318 and the pump 320-2. In some examples, a pressure sensor may
be
placed between the inflatable member 304 and the active valve 352.
[0070] FIG. 4 schematically illustrates an inflatable penile prosthesis
400
having an electronic pump assembly 406 according to an aspect. The electronic
pump
assembly 406 may include any of the features of the electronic pump assembly
(e.g.,
106, 206, 306) and the inflatable penile prostheses (e.g., 100, 200) discussed
herein.
The inflatable penile prosthesis 400 may include a pair of inflatable
cylinders 410,
and the inflatable cylinders 410 are configured to be implanted in a penis.
For
example, one of the inflatable cylinders 410 may be disposed on one side of
the penis,
and the other inflatable cylinder 410 may be disposed on the other side of the
penis.
Each inflatable cylinder 410 may include a first end portion 424, a cavity or
inflation
chamber 422, and a second end portion 428 having a rear tip 432.
[0071] At least a portion of the electronic pump assembly 406 may be
implanted in the patient's body. A pair of conduit connectors 405 may attach
the
electronic pump assembly 406 to the inflatable cylinders 410 such that the
electronic
pump assembly 406 is in fluid communication with the inflatable cylinders 410.
Also, the electronic pump assembly 406 may be in fluid communication with a
fluid
reservoir 450 via a conduit connector 403. The fluid reservoir 450 may be
implanted
into the user's abdomen. The inflation chamber 422 of the inflatable cylinder
410
may be disposed within the penis. The first end portion 424 of the inflatable
cylinder
410 may be at least partially disposed within the crown portion of the penis.
The
second end portion 428 may be implanted into the patient's pubic region PR
with the
rear tip 432 proximate to the pubic bone PB.
[0072] In order to implant the inflatable cylinders 410, the surgeon
first
prepares the patient. The surgeon often makes an incision in the penoscrotal
region,
e.g., where the base of the penis meets with the top of the scrotum. From the
penoscrotal incision, the surgeon may dilate the patient's corpus cavernosum
to
prepare the patient to receive the inflatable cylinders 410. The corpus
cavernosum is
one of two parallel columns of erectile tissue forming the dorsal part of the
body of
the penis, e.g., two slender columns that extend substantially the length of
the penis.
The surgeon will also dilate two regions of the pubic area to prepare the
patient to
receive the second end portion 428. The surgeon may measure the length of the
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corpora cavernosum from the incision and the dilated region of the pubic area
to
determine an appropriate size of the inflatable cylinders 410 to implant.
[0073] After the patient is prepared, the inflatable penile prosthesis
400 is
implanted into the patient. The tip of the first end portion 424 of each
inflatable
cylinder 410 may be attached to a suture. The other end of the suture may be
attached
to a needle member (e.g., Keith needle). The needle member is inserted into
the
incision and into the dilated corpus cavernosum. The needle member is then
forced
through the crown of the penis. The surgeon tugs on the suture to pull the
inflatable
cylinder 410 into the corpus cavernosum. This is done for each inflatable
cylinder
410 of the pair. Once the inflation chamber 422 is in place, the surgeon may
remove
the suture from the tip. The surgeon then inserts the second end portion 428.
The
surgeon inserts the rear end of the inflatable cylinder 410 into the incision
and forces
the second end portion 428 toward the pubic bone PB until each inflatable
cylinder
410 is in place.
[0074] A user may use an external device 401 to control the inflatable
penile
prosthesis 400. In some examples, the user may use the external device 401 to
inflate
or deflate the inflatable cylinders 410. For example, in response to the user
activating
an inflation cycle using the external device 401, the external device 401 may
transmit
a wireless signal to the electronic pump assembly 406 to initiate the
inflation cycle to
transfer fluid from the fluid reservoir 450 to the inflatable cylinders 410.
In some
examples, in response to the user activating a deflation cycle using the
external device
401, the external device 401 may transmit a wireless signal to the electronic
pump
assembly 406 to initiate the deflation cycle to transfer fluid from the
inflatable
cylinders 410 to the fluid reservoir 450. In some examples, during the
deflation cycle,
fluid is transferred back until the pressure in the inflatable cylinders 410
reaches a
partial inflation pressure.
[0075] FIG. 5 illustrates a flow chart 500 depicting example operations
of a
method of operating an electronic pump assembly of an inflatable penile
prosthesis.
The example operations of the flow chart 500 may be performed by any of the
inflatable penile prostheses (e.g., 100, 200, 400) and/or the electronic pump
assemblies (e.g., 106, 206, 306, 406) discussed herein.
[0076] Operation 502 includes receiving, by an antenna of an electronic
pump
assembly, a wireless control signal from an external device. Operation 504
includes
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generating, by a controller, a first control signal to control an active valve
of the
electronic pump assembly. Operation 506 includes generating, by the
controller, a
second control signal to control a pump of the electronic pump assembly.
Operation
508 includes actuating, in response to the first control signal, the active
valve to a
closed position. Operation 510 includes actuating, in response to the second
control
signal, the pump to transfer fluid from a fluid reservoir to an inflatable
member until a
pressure in the inflatable member reaches a threshold level. In some examples,
the
operations may include generating, by the controller, a third control signal
to control
the active valve. In some examples, the operations include actuating, in
response to
the third control signal, the active valve to an open position to transfer at
least a
portion of the fluid from the inflatable member to the fluid reservoir.
[0077] Detailed embodiments are disclosed herein. However, it is
understood
that the disclosed embodiments are merely examples, which may be embodied in
various forms. Therefore, specific structural and functional details disclosed
herein
are not to be interpreted as limiting, but merely as a basis for the claims
and as a
representative basis for teaching one skilled in the art to variously employ
the
embodiments in virtually any appropriately detailed structure. Further, the
terms and
phrases used herein are not intended to be limiting, but to provide an
understandable
description of the present disclosure.
[0078] The terms "a" or "an," as used herein, are defined as one or more
than
one. The term "another," as used herein, is defined as at least a second or
more. The
terms "including" and/or "having", as used herein, are defined as comprising
(i.e.,
open transition). The term "coupled" or "moveably coupled," as used herein, is
defined as connected, although not necessarily directly and mechanically.
[0079] In general, the embodiments are directed to bodily implants. The
term
patient or user may hereafter be used for a person who benefits from the
medical
device or the methods disclosed in the present disclosure. For example, the
patient
can be a person whose body is implanted with the medical device or the method
disclosed for operating the medical device by the present disclosure. For
example, in
some embodiments, the patient may be a human.
[0080] While certain features of the described implementations have been
illustrated as described herein, many modifications, substitutions, changes
and
equivalents will now occur to those skilled in the art. It is, therefore, to
be understood
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that the appended claims are intended to cover all such modifications and
changes as
fall within the scope of the embodiments.
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