Note: Descriptions are shown in the official language in which they were submitted.
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REMOTE CONTROLLED MEDICAL APPARATUS
THE BACKGROUND OF THE INVENTION AND PRIOR ART
The present invention relates generally to a flexible and user-friendly blood
cleaning
treatment, which can be performed in non-hospital environments, such as in the
patient's home.
The human body consists of approximately 60% water ¨ a level which is
important
to maintain for survival. While it is unproblematic to provide the body with
new
water, disposal of surplus water is a major problem in renal patients. One
task of
the normal kidney is to remove superfluous fluid from the blood, such as
water,
urea and other waste products. The resulting urine is transferred to the
bladder and
finally leaves the body during urination. The kidney's second task is to
regulate for
example the balance of electrolytes and acid and base. With malfunctioning
kidneys, disorders may develop in most major body organs, a syndrome called
uremia. If uremia remains untreated, it will lead to death. Uremia is treated
by
kidney transplantation or some form of blood cleaning, either extracorporeal
(e.g. in
the form of hemodialysis, hemofiltration or hemodiafiltration), or
intracorporal (e.g.
in the form of peritoneal dialysis).
Irrespective of which type of blood cleaning treatment that is used, the
treatment
normally requires a substantial amount of time; say three times per week in
four
hours per session. Thus, for a good patient comfort and quality of life, it is
key that
the treatments can be completed in a manner being as straightforward and
flexible
as possible. To this aim, various home dialysis solutions have been developed.
Of
course, a physician must supervise and analyze also these treatments. This can
be
accomplished by means of a smart card, which stores relevant therapy and
treatment history data. The patient brings along his/her smart card when
regularly
visiting the clinic, so that the physician can study the treatment history
data, and if
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necessary update the therapy prescription, which is also stored on the card.
However, the smart card has a limited storage capacity, and therefore this
solution
requires that the patient visit the clinic rather frequently. An online
connection
between a central location (e.g. a hospital) and the home dialysis site may
alleviate
this problem.
US 2003/0001743 describes a personal and/or institutional health and wellness
communications system, wherein a bi-directional communication is established
over a network between a personal medical device and a central monitoring
station.
The medical device, which may be adapted to perform kidney dialysis,
preferably
communicates wirelessly with a local network node (e.g. according to the
Bluetooth
standard).
US 6,406,426 discloses a medical monitoring and alert system, which can be
used
with therapeutic devices, such as hemodialysis machines. Here, a connection is
set
up between a therapeutic device and a central monitoring system. This
connection,
which may include hardwired as well as wireless bi-directional links, enables
patient
information follow-ups, statistics, software updates and remote testing of the
therapeutic device.
Naturally, the above-mentioned online connections between the remote host and
the dialysis machine constitute improvements in relation to the smart card
solution,
for instance with regard to adjustments and testing of the dialysis machine as
such.
However still, a qualified caregiver must manually personalize the machine to
meet
the patient specific needs whenever the prescribed therapy is to be modified,
and/or be adapted to the patient's current condition.
SUMMARY OF THE INVENTION
The object of the present invention is therefore to solve the above problems
and thus
accomplish a solution by means of which a comparatively low degree of
qualified
3
caregiver intervention is required at the treatment site, and at the same
time, the
patient is relatively free to select the location at which the treatment is
effected.
According to one aspect of the invention, the object is achieved with a
medical system
for cleaning the blood of a patient (P), the system (100) comprising:
a dialysis unit (110) adapted to treat the patient's (P) blood in accordance
with
a prescribed therapy, the dialysis unit (110) having a wireless interface
(110W) for
bi-directional exchange of data, and
a gateway unit (120) adapted to communicate with the dialysis unit (110) over
the wireless interface (110W, 120W), the gateway unit (120) having an
interface
(125) adapted to be connected to a remote host (140) via at least one
interconnecting
network (130), and the gateway unit (120) being adapted to provide a bi-
directional
exchange of data between the remote host (140) and the dialysis unit (110),
characterized in that the dialysis unit (110) is adapted to:
store data (DO representing at least one executed treatment of the patient;
transmit at least a fraction (dh) of the stored data (DO to the remote host
(140)
via the gateway unit (120);
transmit at least one effect parameter (Dr) to the remote host (140) via the
gateway unit (120), the at least one effect parameter (Dr) reflecting a result
of a
treatment performed by the dialysis unit (110)
receive control data (DctrI) from the remote host (140) via the gateway unit
(120); and
influence the prescribed therapy in response to control data (DctrI), wherein
the
control data (Darl) defines at least one parameter of a prescribed therapy of
a future
treatment of the patient (P), and the dialysis unit (110) is adapted to
perform the
future treatment in accordance with the prescribed therapy being adjusted with
respect to the at least one parameter, and the at least one parameter of a
prescribed
therapy of a future treatment which is defined by the control data (DctrI),
does not
modify a parameter of a prescribed therapy in respect of an ongoing treatment.
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According to another aspect of the invention, the object is achieved with a
dialysis
unit (110) adapted to clean the blood of a patient (P) in accordance with a
prescribed
therapy, the dialysis unit (110) having a first wireless interface (110W) for
bi-
directional exchange of data, and the dialysis unit (110) being adapted to
communicate with a remote host (140) via a gateway unit (120) having a second
wireless interface (120W) matched to the first wireless interface (110W),
gateway
unit (120) being further connected to the remote host (140) via at least one
interconnecting network (130), characterized in that the dialysis unit (110)
is adapted
to store data (Oh) representing at least one executed treatment of the
patient, transmit
at least a fraction (dh) of the stored data (Oh) to the remote host (140) via
the gateway
unit (120), transmit at least one effect parameter (Dr) to the remote host
(140) via the
gateway unit (120), the at least one effect parameter (Dr) reflecting a result
of a
treatment performed by the dialysis unit (110), receive control data (DdrI)
from the
remote host (140) via the gateway unit (120); and influence the prescribed
therapy in
response to control data (DdrI) received from the remote host (140) via the
gateway
unit (120), wherein the control data (Dctrl) defines at least one parameter of
a
prescribed therapy of a future treatment of the patient (P), and the dialysis
unit (110)
is adapted to perform the future treatment in accordance with the prescribed
therapy
being adjusted with respect to the at least one parameter, and the at least
one
parameter of a prescribed therapy of a future treatment which is defined by
the control
data (DctrI), does not modify a parameter of a prescribed therapy in respect
of an
ongoing treatment.
Thus, by means of the invention, a very high degree of treatment flexibility
is
attained. Namely, the patient can be treated in his/her home, or in any other
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suitable environment, and at the same time, the treatment can be monitored,
and if
necessary be adjusted from a remote location, such as a hospital.
Further advantages, advantageous features and applications of the present
invention will be apparent from the following description and the dependent
claims.
BRIEF DESCRIPTION OF THE DRAWINGS
The present invention is now to be explained more closely by means of
preferred
embodiments, which are disclosed as examples, and with reference to the
attached
drawings.
Figure 1 shows a block diagram over a medical system according to one
embodiment of the invention, and
Figure 2 shows a flow diagram which illustrates the general method
according
to the invention.
DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION
Figure 1 shows one embodiment of a proposed medical system 100 for cleaning
the blood of a patient P under supervision of a central resource. The system
100
includes a dialysis unit 110, a gateway unit 120 and a remote host 140.
The dialysis unit 110 is adapted to treat the patient's P blood in accordance
with a
prescribed therapy by means of an extra- or an intracorporal treatment
process. In
any case, the dialysis unit 110 has a wireless interface 110W for bi-
directional
exchange of data, i.e. for receiving a first type of data Dctr, and 1)3,õ, and
for
transmitting a second type of data Dr and Ph. The wireless interface 110W is
preferably adapted to the BluetoothTM standard and/or ZigbeeTM standard.
Alternatively, the wireless interface 110W implements an infrared interface or
it is
based on another type of short-range wireless technology.
The gateway unit 120 has a matching wireless interface 120W, i.e. an interface
that
is adapted to communicate with the dialysis unit 110 over the interface 110W.
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Moreover, the gateway unit 120 has an interface 125, which is adapted to be
connected to the remote host 140 via at least one interconnecting network 130.
Depending on the interface format of a relevant access node to the network(s)
130,
the interface 125 may be a wireless and/or a wire-bound interface. For
example, if
the access node is an Internet node, a PSTN node or a LAN node, the interface
125 is preferably wire-bound; whereas if the access node is a PLMN node or a
WLAN node, the interface 125 is preferably wireless (PSTN = Public Switched
Telephone Network; PLMN = Public Land Mobile Network (e.g. GSM, GPRS or
3G/UMTS); VVLAN = Wireless Local-Area Network). Thus, by means of the
interfaces 125 and 120W respectively, the gateway unit 120 is adapted to
provide a
bi-directional exchange of data between the remote host 140 and the dialysis
unit
110. Specifically, the gateway unit 120 is adapted to receive therapy result
Dr; Ph
and patient status data Dbp and Dw over the wireless interface 120W. The
gateway
unit 120 is also adapted to receive control data Dctri from the remote host
140 via
the interface 125 and to forward the control data Dctrl over the wireless
interface
120W to the dialysis unit 110. Furthermore, the dialysis unit 110 is adapted
to
influence the prescribed therapy in response to the received control data
Dctrl=
The proposed gateway unit 120 is advantageous in that it standardizes the
interface towards the dialysis unit, i.e. the gateway unit 120 renders the
dialysis unit
110 independent from the format of any interconnecting networks 130. More
importantly, however, the gateway unit 120 can ensure that the connection to
the
remote host 140 is protected against spoofing and eavesdropping, without
requiring
any security measures in the dialysis unit 110. Instead, the necessary
encryption
and authentication can be negotiated between the remote host 140 and the
gateway unit 120. Of course, if the wireless interface 110W-120W is based on
Bluetooth or Zigbee technology, the encryption and authentication available
under
these standards are preferably used to protect also the link between the
gateway
unit 120 and the dialysis unit 110.
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According to one preferred embodiment of the invention, the dialysis unit 110
is
adapted to receive the control data Dad during an ongoing treatment of the
patient
P, and in response to the data Ddri modify at least one parameter of the
prescribed
therapy in respect of the ongoing treatment before completing this treatment.
The control data Dctri may also define at least one parameter of a prescribed
therapy of a future treatment of the patient P (i.e. a treatment that has not
yet been
initiated). To this aim, the dialysis unit 110 includes a storage module (not
shown),
which is adapted to store the at least one parameter at least until said
future
treatment is to be completed. Of course, the dialysis unit 110 is then
configured to
perform the future treatment in accordance with a prescribed therapy that has
been
adjusted with respect to the at least one parameter. Dialysis liquid volumes,
treatments times and OF (Ultra Filtration) values constitute examples of such
parameters.
Depending on the type, number and extent of parameters included in the control
data Dctri, this data may define up to an entire prescribed therapy of a
future
treatment of the patient P.
Since the wireless interface 110W is bi-directional, the dialysis unit 110 may
also
transmit uplink information to the gateway unit 120. For example, according to
one
preferred embodiment of the invention, the dialysis unit 110 is adapted to
transmit
at least one effect parameter Dr to the gateway unit 120. The at least one
effect
parameter D, may include data representing a glucose concentration in the
patient's
P blood and/or a body water level.
The gateway unit 120, in turn, is adapted to forward the at least one effect
parameter Dr to the remote host 140. The effect parameter(s) Dr reflect/s a
result of
a treatment performed by the dialysis unit 110. Hence, based on this/these
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parameter/s conclusions can be drawn at the remote host 140 whether or not the
treatment was successful.
According to one preferred embodiment of the invention, the system 100
includes a
blood pressure monitor 115, which is adapted to register at least one blood
pressure related parameter in respect of the patient P (typically the
diastolic
pressure, the systolic pressure, the pulse and/or the medium arterial
pressure,
MAP). The monitor 115 has a wireless interface 115W towards the gateway unit
120, such that at least one of the at least one blood pressure related
parameter Dbp
can be transmitted to the remote host 140 via the gateway unit 120.
Preferably, the dialysis unit 110 is adapted to transmit at least one machine
parameter Dm to the remote host 140 via the gateway unit 120. The at least one
machine parameter Dm reflects a status for at least one characteristic of the
dialysis
unit 110, such as one or more pressure levels, various fluid flow rates,
and/or liquid
temperatures at different instances during the treatment. Alternatively, or as
a
complement thereto, the at least one machine parameter Dm may reflect a
settings
of various components, e.g. valves, in the dialysis unit 110. Thus, the remote
host
140 may log the behavior of the dialysis unit 110. Consequently, the physician
is
aided in his/her diagnosis work. The hardware maintenance and service are also
facilitated.
Preferably, the system 100 includes a scale unit 117, which is adapted to
register a
weight parameter D in respect of the patient P, such as the entire body
weight.
The scale unit 117 has a wireless interface 117W towards the gateway unit 120.
Thus, the scale unit 117 can transmit the weight parameter D,õ, to the remote
host
140 via the gateway unit 120.
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According to one preferred embodiment of the invention, the dialysis unit 110
may
include, or be associated with, a memory module 111, which is adapted to store
data Ph representing at least one executed treatment of the patient P (i.e.
completed treatments as well as any treatments having been aborted before
being
completed). Furthermore, the dialysis unit 110 is adapted to transmit at least
a
fraction dh of the stored data Ph to the remote host 140 via the gateway unit
120.
Hence, the remote host 140 can be informed of some or all characteristics of
one or
more earlier treatments.
According to one preferred embodiment of the invention, the system includes a
first
data input unit 118 (e.g. a PDA, a laptop or a smart phone), which is adapted
to
register manually entered information D. This information Dp relates to
subjective
data, such as how the patient experienced the treatment, or the patient's
current
physical condition. The first data input unit 118 has a wireless interface
towards the
gateway unit 120, and the unit 118 is adapted to transmit the manually entered
information Dp to the remote host 140 via the gateway unit 120. Thereby, a
physician
at the remote host 140 can gain valuable information regarding the treatment,
which
may be helpful when prescribing future treatments. Additionally, the first
data input
unit 118 may be adapted to register event data, i.e. actions performed by the
patient
such as alarm acknowledgements or a premature ending of a treatment, and
forward
this data to the remote host 140 via the gateway unit 120.
It is also desirable if the system includes a second data input unit 119 (e.g.
a bar
code reader or a portable OCR scanner (OCR = Optical Character Recognition),
which is adapted to automatically register machine readable information.
Furthermore, the unit 119 is adapted to forward the machine-readable
information
to the remote host 140 via the gateway unit 120. This information transfer may
either be effected via the first data input unit 118, as illustrated in Figure
1, or over
the gateway unit 120 directly (for instance over the wireless interface 120W).
By
means of the second data input unit 119, the user may enter data pertaining to
the
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dialysis fluid used, and thus provide the remote host with vital treatment
information.
Preferably, the dialysis unit 110 includes, or is associated with, a computer
readable medium 112, e.g. a memory module, which stores software for
controlling
the above-described functionality. The software, in turn, contains at least
one
software module that is adapted to control at least one function of the
dialysis unit
110. Moreover, the dialysis unit 110 is adapted to receive software-updating
data
D5w from the remote host 140 via the gateway unit 120. In response to the
software
updating data Dsw, the dialysis unit 110 is adapted to modify at least one of
the at
10 least one software modules. Thus, the modus operandi of the dialysis
unit 110 can
be altered/updated from the remote host 140.
In order to sum up, the general method according to the invention will be
described
below with reference to the flow diagram in figure 2.
A first step 210 transmits control data Dctri from the remote host 140 to the
gateway
unit 120 (i.e. over the at least one interconnecting network 130). A step 220
then
receives the control data in the gateway unit 120. Subsequently, a step 230
transmits the control data Dctrt from the gateway unit 120 to the dialysis
unit 110
over the wireless interface 120W-110W. Thereafter, a step 240 receives the
control
data Dctri in the dialysis unit 110. Finally, the prescribed therapy to be
performed by
the dialysis unit 110 is adapted in response to the received control data
Dctri=
According to a preferred embodiment of the invention, the method also involves
transmitting an acceptance message from the dialysis unit 110 over the
wireless
interface to the gateway unit (e.g. between steps 240 and 250). The acceptance
message acknowledges reception of the control data Dctri in the dialysis unit
110. It
is further preferable if the gateway unit 120 is adapted to retransmit the
control data
Dctri to the dialysis unit 110 until such an acceptance message has been
received.
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Moreover, upon receipt of the acceptance message, the dialysis unit 110 is
preferably adapted to forward the acceptance message (or any equivalent
message) to the remote host 140. Thereby, the remote host 140 can be informed
of
the fact that the prescribed therapy and/or the modus operandi the dialysis
unit 110
will be updated as desired.
All of the process steps, as well as any sub-sequence of steps, described with
reference to the figure 2 above may be controlled by means of a programmed
computer apparatus. Moreover, although the embodiments of the invention
described above with reference to the drawings comprise computer apparatus and
processes performed in computer apparatus, the invention thus also extends to
computer programs, particularly computer programs on or in a carrier, adapted
for
putting the invention into practice. The program may be in the form of source
code;
object code, a code intermediate source and object code such as in partially
compiled form, or in any other form suitable for use in the implementation of
the
process according to the invention. The carrier may be any entity or device
capable
of carrying the program. For example, the carrier may comprise a storage
medium,
such as a Flash memory, a ROM (Read Only Memory), for example a CD
(Compact Disc) or a semiconductor ROM, an EPROM (Erasable Programmable
Read-Only Memory), an EEPROM (Electrically Erasable Programmable Read-Only
Memory), or a magnetic recording medium, for example a floppy disc or hard
disc.
Further, the carrier may be a transmissible carrier such as an electrical or
optical
signal which may be conveyed via electrical or optical cable or by radio or by
other
means. When the program is embodied in a signal which may be conveyed directly
by a cable or other device or means, the carrier may be constituted by such
cable
or device or means. Alternatively, the carrier may be an integrated circuit in
which
the program is embedded, the integrated circuit being adapted for performing,
or for
use in the performance of, the relevant processes.
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The term "comprises/comprising" when used in this specification is taken to
specify
the presence of stated features, integers, steps or components. However, the
term
does not preclude the presence or addition of one or more additional features,
integers, steps or components or groups thereof.
The invention is not restricted to the described embodiments in the figures,
but may
be varied freely within the scope of the claims.
