U.S. patent application number 10/841320 was filed with the patent office on 2004-10-21 for patient directed therapy management.
This patent application is currently assigned to Medtronic, Inc.. Invention is credited to Bauhahn, Ruth Eilnor, Forsberg, John W., Nelson, Steven James.
Application Number | 20040210274 10/841320 |
Document ID | / |
Family ID | 24236203 |
Filed Date | 2004-10-21 |
United States Patent
Application |
20040210274 |
Kind Code |
A1 |
Bauhahn, Ruth Eilnor ; et
al. |
October 21, 2004 |
Patient directed therapy management
Abstract
An apparatus and method that allows a patient to access stored
preset patient therapy programs, that are resident in a medical
device, and to create personalized therapy programs or automatic
timing therapy programs from preset therapy programs to accommodate
the patient's particular activity. Alternatively, the patient can
select and access stored preset patient therapy programs and
combine at least two modified or unmodified preset therapy programs
to create personalized therapy programs.
Inventors: |
Bauhahn, Ruth Eilnor;
(Fridley, MN) ; Forsberg, John W.; (St. Paul,
MN) ; Nelson, Steven James; (Wyoming, MN) |
Correspondence
Address: |
BANNER & WITCOFF, LTD.
TEN SOUTH WACKER DRIVE
SUITE 3000
CHICAGO
IL
60606
US
|
Assignee: |
Medtronic, Inc.
Minneapolis
MN
|
Family ID: |
24236203 |
Appl. No.: |
10/841320 |
Filed: |
May 7, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10841320 |
May 7, 2004 |
|
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|
09560064 |
Apr 27, 2000 |
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Current U.S.
Class: |
607/60 |
Current CPC
Class: |
A61N 1/37247
20130101 |
Class at
Publication: |
607/060 |
International
Class: |
A61N 001/08 |
Claims
What is claimed is:
1. A patient directed therapy management system comprising in
combination: a medical device comprising a telemetry block and
memory with at least two preset clinician therapy programs; and a
patient programmer comprising a telemetry block, the patient
programmer able to create at least one personalized therapy program
from the at least two preset clinician therapy programs, the
patient programmer further able to store and execute the at least
one personalized therapy program in the medical device.
2. The patient directed therapy management system of claim 1
wherein the personalized therapy program comprises at least one
personalized therapy settings.
3. The patient directed therapy management system of claim 2
wherein the personalized therapy settings are comprised of at least
one of an amplitude, a rate, a pulse width, a pulse frequence,
electrode polarities, or a directional sequence.
4. The patient directed therapy management system of claim 2
wherein the patient programmer executes a personalized therapy
algorithm.
5. The patient directed therapy management system of claim 2
wherein the patient programmer executes a timing algorithm.
6. The patient directed therapy management system of claim 4 or 5
wherein the patient uses a graphical display screen and input
medium to create and store the personalized therapy programs.
7. The patient directed therapy management system of claim 2
wherein the medical device and the patient programmer communicate
via telemetry.
8. The patient directed therapy management system of claim 2
wherein the medical device is an implantable neuro stimulator.
9. The patient directed therapy management system of claim 2
wherein the medical device is an external neuro stimulator.
10. A patient directed therapy management system comprising in
combination: a medical device comprising a telemetry block and
memory with at least two preset clinician therapy programs; a
patient programmer comprising a telemetry block, the patient
programmer able to allow creation of at least one personalized
therapy program from the at least two preset clinician therapy
programs, and storage and execution of the at least one
personalized therapy program in the medical device, wherein the
personalized therapy program comprises at least one personalized
therapy setting: and wherein the medical device is selected from
the group consisting of a pacemaker, a defibrillator, a cochlear
implant, an implantable diagnostic device, and an implantable
pump.
11. A patient programmer for patient directed therapy management
comprising in combination: an input medium; a telemetry block; and
a controller able to create at least one personalized therapy
program from at least two preset clinician therapy programs, the
controller able to store the at least one personalized therapy
program in a medical device.
12. The patient programmer of claim 11 wherein the personalized
therapy program comprises at least one personalized therapy
setting.
13. The patient programmer of claim 12 wherein the personalized
therapy setting are comprised of at least one of an amplitude, a
rate pulse width, a pulse frequency, electrode polarities, or a
directional sequence.
14. The patient programmer of claim 12 wherein the personalized
therapy program executed by the patient programmer comprises a
personalized therapy algorithm.
15. The patient programmer of claim 12 wherein the personalized
therapy program comprises a timing algorithm.
16. The patient programmer of claim 14 or 15 wherein the patient
uses a graphical screen interface and input medium to create and
store the personalized therapy programs.
17. The patient programmer of claim 12 wherein the medical device
and the patient programmer communicate via telemetry.
18. The patient programmer of claim 12 wherein the medical device
is an implantable neuro stimulator.
19. The patient directed therapy management system of claim 12
wherein the medical device is an external neuro stimulator.
20. A patient programmer for patient directed therapy management
comprising in combination: an input medium; a telemetry block; a
controller able to create at least one personalized therapy program
from at least two preset clinician therapy programs, the controller
able to store the at least one personalized therapy program in a
medical device, the personalized therapy program comprising at
least one personalized therapy setting; and wherein the medical
device is a medical device selected from a group consisting of a
pacemaker, defibrillator, a cochlear implant, an implantable
diagnostic devices, and an implantable pump.
21. A patient programmer comprising: an input medium; a programming
means, connected to the input medium, for creating at least one
personalized therapy program from at least two preset clinician
therapy programs; and a communication means, connected to the
programming means, for storing and executing at least one
personalized therapy program in a medical device.
22. A patient programmer for patient directed therapy management
comprising in combination: an input medium for receiving a
plurality of personalized therapy settings from a patient, wherein
each personal therapy setting provide settings for a plurality of
parameters of a therapy program selected from the group consisting
of an amplitude, a pulse rate, a pulse width, a pulse frequency, an
electrode polarity, and a directional sequence; a telemetry block;
and a controller able to create a personalized therapy program for
each personalized therapy setting received from the patient and
cause the personalized therapy programs to be stored in a medical
device via the telemetry block, wherein the patient can
subsequently instruct the medical device via the patient programmer
to provide therapy to the patient in accordance with one of the
personalized therapy programs or a preset clinician therapy
program.
23. The patient programmer of claim 22 wherein the controller
executes a personalized therapy algorithm.
24. The patient programmer of claim 22 wherein the controller
executes a timing algorithm.
25. The patient programmer of claim 22 wherein the input medium is
a graphical screen interface to create the personalized therapy
program.
26. The patient programmer of claim 22 wherein the telemetry block
is capable of communicating with an implantable neuro
stimulator.
27. The patient directed therapy management system of claim 22
wherein the telemetry block is capable of communicating with an
external neuro stimulator.
28. The patient programmer of claim 22 wherein the personalized
therapy program is based on the patient's activity.
29. The patient programmer of claim 22 wherein the personalized
therapy program is based on a time of day.
30. The patient programmer of claim 29 wherein the controller is
capable of programming the implanted device to provide therapy to
the patient in accordance with the personalized therapy program
associated with the particular time of day.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional application of U.S.
application Ser. No. 09/560,064 filed Apr. 27, 2000, which is
incorporated herein by reference in its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to medical
implantable devices. More particularly, the invention relates to an
apparatus and method for patient directed therapy management of
implantable medical devices used to influence the human body.
BACKGROUND OF THE INVENTION
[0003] The medical device industry produces a wide variety of
electronic and mechanical devices for treating patient medical
conditions. Depending upon the medical condition, medical devices
can be surgically implanted or connected externally to the patient
receiving treatment. Clinicians use medical devices alone or in
combination with drug therapies and surgery to treat patient
medical conditions. For some medical conditions, medical devices
provide the best, and sometimes the only, therapy to restore an
individual to a more healthful condition and a fuller life.
[0004] Implantable medical devices are commonly used today to treat
patients suffering from various ailments. Implantable medical
devices can be used to treat any number of conditions such as pain,
incontinence, movement disorders such as epilepsy and Parkinson's
disease, and sleep apnea. Additionally, use of implantable medical
devices appears promising to treat a variety of physiological,
psychological, and emotional conditions.
[0005] One type of implantable medical device is an Implantable
Neuro Stimulator (INS). The INS is implanted at a predetermined
location in the patient's body. The INS generates and delivers mild
electrical impulses to neurostimulation areas in the body using an
electrical lead. The INS electrical stimulation signals at
neurostimulation sites or areas influence desired neural tissue,
tissue areas, nervous system and organs to treat the ailment of
concern. The stimulation sites can also include the spinal cord,
brain, body muscles, peripheral nerves or any other site selected
by a physician. For example, in the case of pain, electrical
impulses may be directed to cover the specific sites where the
patient is feeling pain. Neurostimulation can give patients
effective pain relief and can reduce or eliminate the need for
repeat surgeries and the need for pain medications.
[0006] In the case of an INS, the system generally includes an
implantable neuro stimulator (INS) (also known as an implantable
pulse generator (IPG)), an external physician or clinician
programmer, a patient programmer and at least one electrical lead.
An INS is typically implanted near the abdomen of the patient, or
other stimulation area as required. The lead is a small medical
wire with special insulation and contains a set of electrodes
(small electrical contacts) through which electrical stimulation is
delivered. The INS can be powered by an internal source such as a
rechargeable or non-rechargeable battery or by an external source
such as a radio frequency transmitter. The INS contains electronics
to generate and send precise, electrical pulses to the stimulation
area to provide the desired treatment therapy. The clinician
programmer is an external device that allows the physician or
clinician to create and store preset stimulation therapy to be
delivered by the INS. The clinician programmer communicates with
the INS using radio waves, for example via telemetry. The patient
programmer is an external hand-held device that allows the patient
to optimize the stimulation therapy delivered by the INS. The
patient programmer also communicates with the INS using radio
waves, such as telemetry.
[0007] In existing INS devices, a clinician typically creates and
stores preset patient therapy programs that are executed by the INS
to deliver therapy to the patient. The preset patient therapy
programs include specific therapy parameters that are set and
created by a clinicians based on industry or clinician preferences,
patient feedback, a patient's test results, or a combination of all
of the above. The patient therapy programs are then downloaded into
INS memory using the clinician programmer. The patient therapy
programs then reside in both clinician programmer memory and INS
memory. The stored preset patient therapy programs, which include
specific therapy parameters, will allow the INS to generate the
appropriate electrical stimulation signals for the patient's
specific needs. The stored patient therapy programs contain
parameters, including for example, electrode settings, signal
intensity or strength (amplitude), the signal duration (pulse
width), and the signal timing and cycling (pulse frequency or
rate).
[0008] In addition, the electrodes associated with a medical
device, such as an INS, may be arranged in a predetermined physical
array or layout configuration at the stimulation site in the
patient. In such a case, certain preset therapy parameters in the
stored patient therapy programs will allow the INS to generate
electrical stimulation signals at the electrodes in a particular
directional sequence and physical direction, relative to their
physical placement in the patient's body.
[0009] At present, patients do not have the ability to select and
assemble the preset therapy programs, which were created by the
clinician, or to create his/her own personalized therapy programs.
A patient can typically access the stored preset clinician therapy
programs but cannot create personalized therapy programs
himself/herself. A patient must use and live with the preset
therapy programs that have been created by the clinician. Moreover,
the stimulation areas targeted by the INS's electrical leads on a
patient's body are usually situated to alleviate or address pain or
discomfort due to one body position or activity, e.g., sitting
compared to walking, jogging or running. As a result, the
combination of specifically situated stimulation areas and
unchangeable clinician created preset therapy programs can lead to
discomfort when a patient engages in activities that were not
accounted for or foreseen by the clinician. The inability to modify
the stored therapy programs can thus limit the activities that a
patient may wish to engage in.
[0010] For the foregoing reasons there is a need for an apparatus
and method that will allow patients to access stored preset
clinician therapy programs so that the patient can create new
personalized therapy programs that will enable the patient to
participate in a variety of activities without undue discomfort or
the need to visit a clinician for additional preset therapy
programs.
[0011] It is an objective of the present invention to provide an
apparatus and method to give patients the ability to assemble,
label and store their own personalized therapy programs, on demand,
from among the preset clinician therapy programs that are resident
in INS memory.
[0012] It is an objective of the present invention to provide an
apparatus and method to give patients more control to create
personalized therapy programs and settings to fit their unique
lifestyles thereby increasing patient satisfaction.
SUMMARY OF THE INVENTION
[0013] The present invention provides an apparatus and method that
allows a patient to select and access stored patient therapy
programs, that are resident in the INS device, and modify the
stored therapy programs to accommodate his/her particular
lifestyle, thereby creating and storing personalized therapy
programs. The patient can select and access stored patient therapy
programs and combine in an unmodified manner at least two of the
accessed therapy programs to create personalized therapy programs.
The present invention also gives the patient the ability to select
and access stored patient therapy programs, to modify the accessed
preset therapy programs and then combine the modified preset
therapy programs to create personalized therapy programs.
[0014] In accordance with the present invention, there is provided
a method for patient directed therapy management in an implantable
neuro stimulator (INS). The method comprised of: storing preset
clinician therapy programs with preset therapy settings in an INS
device; accessing the preset clinician therapy programs by the
patient, via telemetry communication between the INS device and a
patient programmer; modifying at least one of the accessed preset
clinician therapy programs on a patient programmer to create at
least one personalized therapy program with personalized therapy
settings; and storing the personalized therapy program in the INS
device for subsequent use by the patient. A patient can then select
from the clinician preset therapy programs or from the newly
created and stored personalized therapy settings in accordance with
the activity and/or preference of the patient.
[0015] In accordance with the present invention, there is provided
a system for patient directed therapy management that allows a
patient to select and access stored patient therapy programs that
are resident in the INS device and to modify the stored therapy
programs to create and store personalized therapy programs that
accommodate the patient's particular lifestyle. The system
apparatus is comprised of an implantable neuro stimulator (INS)
with memory able to receive, store and execute preset patient
therapy programs; a physician or clinician programmer for creating
and storing preset patient therapy programs; a patient programmer
with a display screen for creating and storing personalized therapy
programs; and electrical lead electrodes for delivering therapy
signals. In the system for patient directed therapy management, the
clinician programmer, the patient programmer and the INS
communicate using radio waves, for example, via telemetry.
[0016] In other embodiments, the apparatus and method for patient
directed therapy management of the present invention can be used
with any number of implantable systems requiring the use of preset
therapy programs, including, but not limited to, pacemakers,
defibrillators, cochlear implants, implantable diagnostic devices
for detecting bodily conditions of certain organs, like the brain
or the heart, and drug delivery systems having an implantable
pump.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 illustrates an implantable medical device as could be
implanted in a human body to deliver stimulation therapy.
[0018] FIGS. 2A-D illustrate locations where the implantable
medical device can be implanted in the human body other than the
location shown in FIG. 1.
[0019] FIG. 3 is a schematic block diagram of an INS in accordance
with a preferred embodiment of the present invention.
[0020] FIG. 4 depicts a block diagram that shows a preferred method
of the present invention to create personalized therapy
programs.
[0021] FIG. 5 is a block diagram representation showing in more
detail certain steps of FIG. 4 for creating personalized therapy
programs.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0022] The present invention is an apparatus and method that allows
a patient to select and access stored preset clinician patient
therapy programs from INS memory and to modify the preset clinician
therapy programs to create and store personalized therapy programs
through the use of a patient programmer. The present invention
gives the patient the ability to configure personalized therapy
programs that accommodate the patient's particular needs,
lifestyle, and desires from combined and/or modified stored preset
clinician therapy programs.
[0023] FIG. 1 shows a general environment of an Implantable Neuro
Stimulator (INS) 5 medical device in a patient 6 including leads
15A and 15B, and lead extensions 10A and 10B. The INS 5 is
preferably a modified implantable pulse generator that will be
available from Medtronic, Inc. with provisions for multiple pulses
occurring either simultaneously or with one pulse shifted in time
with respect to the other, and having independently varying
amplitudes, pulse widths and directional sequence. The INS 5
contains a power source and electronics to send precise, electrical
pulses to the spinal cord, brain, or neural tissue to provide the
desired treatment therapy. The INS 5 can be powered by an internal
source such as a rechargeable or non-rechargeable battery or by an
external source such as a radio frequency transmitter. In a
preferred embodiment of the present invention, the INS 5 provides
electrical stimulation by way of pulses, however other forms of
stimulation may be used such as continuous electrical
stimulation.
[0024] The INS 5 can use one or more leads 15A and 15B and
extensions 10A and 10B for delivering therapy. The leads 15A and
15B, which are surgically implanted, are comprised of one or more
insulated electrical conductors with a connector on the proximal
end 9A and 9B and electrical contacts or electrodes 20A and 20B on
the distal end 16A and 16B. A lead 15A and 15B is a small medical
wire with special insulation. Those skilled in the art will
appreciate that any variety of leads may be used to practice the
present invention.
[0025] As shown in FIG. 1, the leads 15A and 15B are implanted and
positioned to stimulate a specific site or area. Alternatively, the
leads 15A and 15B may be positioned along a peripheral nerve,
adjacent neural tissue, positioned to stimulate muscle tissue or
other stimulation site chosen by a clinician. The leads 15A and 15B
contain one or more electrodes (small electrical contacts) through
which electrical stimulation is delivered from the INS 5 to the
targeted neural tissue. The electrodes 20A and 20B may be arranged
in a predetermined physical layout. For example, where there is
more than one electrode 20A and 20B, the electrodes may be arranged
in a linear array, in multiple linear arrays, or in a particular
geometric array such as a triangle, square, rectangle, circle, etc.
In addition, the INS 5 may deliver stimulation therapy signals via
the electrodes in a predetermined directional sequence based on the
electrode's physical layout in the stimulation area.
[0026] FIGS. 2A-D generally illustrate locations where the INS can
be implanted in the human body other than the location shown in
FIG. 1, i.e., within the lower left abdominal region of the patient
6 illustrated in FIG. 2C. Other preferred embodiments for the
placement of INS 5 within a human patient are further shown in
FIGS. 2A, 2B, and 2D. As shown in FIG. 2A, the INS 5 can be
implanted in a pectoral region of the patient. As shown in FIG. 2B,
the INS 5 can be implanted in a region behind the ear of a patient
6, and more specifically in the mastoid region. As shown in FIG.
2D, the INS 5 can be placed in the lower back or upper buttock
region of the patient 6.
[0027] FIG. 3 generally depicts system components of a preferred
embodiment of the present invention that allows a patient to select
and access preset patient therapy programs from the INS 5 in
preparation for creating personalized therapy programs. The
apparatus included are an INS 5 with corresponding leads 15A and
15B, a physician or clinician programmer 40 and a patient
programmer 50. In the system apparatus, the clinician programmer
40, the patient programmer 50 and the INS 5 communicate using radio
waves, for example via telemetry 3 and 4.
[0028] In a preferred embodiment, the clinician programmer 40 is
used by the clinician to create preset clinician therapy programs
for a particular patient. The clinician can also modify the preset
therapy stored in the INS memory 100, troubleshoot the INS 5, and
periodically communicate with the INS 5 to manage the patient
therapy and collect INS data. The clinician can create the preset
clinician therapy programs via the clinician programmer input
medium or device 43, for example a keyboard, or any other input
component recognized by the clinician programmer controller 45.
[0029] The preset clinician therapy programs include specific
therapy parameters and electrode settings that can be based on
industry or clinician preferences, patient feedback, patient test
results, or a combination of all. The clinician can simultaneously
view the preset programs as he/she is creating them on the
graphical display screen 41. Upon completion of the preset therapy
programs, the clinician programmer controller 45 will execute the
clinician's instruction to save the preset programs. The clinician
programmer controller 45 will save the preset programs in its
memory 47 and download a copy to the INS memory 100 via telemetry
3. In a preferred embodiment, only a copy of the preset clinician
therapy programs are downloaded to the INS device 5. A master copy
of the preset clinician therapy programs remains with the clinician
in the clinician programmer memory 47. The stored patient therapy
programs (both preset and personalized) in the INS device 5 will
allow the INS device 5 to generate the electrical stimulation
signals for the patient's specific needs. The therapy programs will
control such electrode settings as signal amplitude, rate, pulse
width, and directional sequence.
[0030] In an embodiment of the present invention, as will be
discussed below, a patient can access the preset clinician therapy
programs (PCTP) stored in the INS via the patient programmer 50.
The patient programmer 50 can comprise a graphical display screen
60, an input medium or device 70, a patient program controller 55,
memory 75 and a telemetry block 65. Having accessed a PCTP, the
patient can then create at least one personalized therapy program
from the accessed PCTP. The patient can then store the new
personalized therapy program in the INS 5 via the patient
programmer 50 input device 70.
[0031] For example, in the embodiment shown in FIG. 3, a patient
could step through the following to create and store at least one
personalized therapy program 190 (discussed with reference to FIG.
5). First, a patient would turn the patient programmer 50 ON and
start the process in a first Start Screen. Second, the patient
would select a Review function and interrogate the INS 5 via the
input device 70. The patient would then select a Select Menu
function that brings up a Selection Screen on the graphical display
screen 60. The Selection screen would display a Menu indicating the
various preset clinician therapy programs (PCTP) 170 (discussed in
more detail with reference to FIG. 5) that are resident in the INS
memory 100. The patient could then scroll through the Menu (on the
graphical display screen 60) and select the particular PCTP 170
that he/she wishes to access in order to create at least one
personalized therapy program. Having accessed a PCTP 170, the
patient can then review and modify the preset clinician therapy
settings (PCTS) 180 (discussed in more detail with reference to
FIG. 5) that correspond to the accessed PCTP 170. The patient may
then select and optimize a PCTS 180 as necessary or desired by use
of the graphical display screen 60 and the input device 70.
[0032] The patient can then make changes as desired for any of the
other remaining PCTS 180 of the accessed PCTP 170 as necessary to
create a personalized therapy program 190. Once the patient has
created a personalized therapy program 190, a Save function can be
selected. A Save screen could then be displayed where the user
would create a label for the created personalized therapy program.
For example, the user could label the just created personalized
therapy program 190 a "Sleep" program. The patient would then
select a Store function and a Store screen would be displayed. The
patient would then, via the input medium key for example, store the
personalized therapy program in the INS memory 100. The patient
programmer controller 55 will execute the patient's instruction to
save the new programs. The patient programmer can save the new
programs in its memory 75 and download a copy to the INS memory
100. The new programs will be transmitted via telemetry 4 to the
INS 5 where the will be saved in INS memory 100. The patient could
repeat the above steps to create other personalized therapy
programs 190, for example programs such as "Running", "Eating",
"Sitting", "Exercising" and others.
[0033] The steps just discussed in creating personalized therapy
programs 190 involve patient interaction with the graphical display
screen 60 and input device 70 of the patient programmer 50 and can
be an embodiment of a personalized therapy algorithm. Those of
skill in the art will readily recognize that the patient's commands
and instructions are being carried out by the patient programmer
controller 55. The controller 55 will then transmit instructions
via its telemetry block 65 to the INS 5.
[0034] In other embodiments, the patient could create personalized
therapy programs as combinations of unmodified preset programs, or
combinations of both modified and unmodified preset clinician
therapy programs (PCTS) via a similar process.
[0035] Having created and stored personalized therapy programs, the
patient can then access, modify is necessary and execute at least
one personalized therapy programs via the patient programmer 50. A
patient can access the personalized therapy programs via the
patient programmer 50. Having accessed the personalized therapy
settings, the patient can then optimize and execute the
personalized therapy programs to receive therapy.
[0036] For example, a patient could step through the following to
access and execute at least one personalized therapy program 190.
First, a patient would turn the patient programmer 50 ON and start
the process in a first Start Screen. Second, the patient would
select a Review function and interrogate the INS 5 via the input
device 70. The patient would then select a Select Menu function
that brings up a Selection Screen on the graphical display screen
60. The Selection screen would display a Menu indicating the
various preset clinician therapy programs (PCTP) 170 and
personalized therapy programs 190 that are resident in the INS
memory 100. The patient could then scroll through the Menu and
select the particular personalized therapy program that he/she
wishes to view access in order to execute for therapy via the INS.
Having accessed a personalized therapy program, the patient may
then select a personalized therapy program and optimize as
necessary or desired by use of the graphical display screen 60 and
the input device 70.
[0037] If no optimization of the accessed personalized therapy
program 190 is done, then an Execute function is selected via the
input device 70. An Execute Personalized Therapy Screen will be
displayed on the patient programmer display 60. The patient will
then select execution of the accessed personalized therapy program
190, for example via the input device 70.
[0038] If the patient does optimize the accessed personalized
therapy program 190, the Save function would be selected. A Save
screen would then be displayed where the user would select a Store
function. In a Store screen the patient would then, via the input
medium key for example, store the optimized personalized therapy
program 190 in the INS device 5. The Execute function is then
selected via the input device 70. An Execute Personalized Therapy
Screen will be displayed where the patient will select execution of
the accessed personalized therapy program 190, for example via the
input device 70. Again, the patient programmer controller 55 will
carry out the patient's instruction to execute, and optimize if
desired, the personalized therapy program 190.
[0039] In another embodiment, a patient will be able to execute an
automatic timing algorithm on the patient programmer controller 55.
The execution of the timing algorithm is similar to the
personalized therapy algorithm just discussed. However, while the
personalized therapy algorithm allows the patient to create
personalized therapy programs and download them to the INS memory
100, the timing algorithm will allow the patient to create
personalized automatic sequencing programs where personalized
therapy programs, preset therapy programs, or a combination of both
will automatically be executed by the INS 5. The patient will store
the personalized automatic sequencing programs in the INS memory
for subsequent execution at predetermined times for predetermined
periods of time. For example, the patient could create a
personalized automatic sequencing program that automatically
executes certain predetermined therapy programs every morning at
6:30 AM for 1.5 hours.
[0040] The INS 5 also uses telemetry 3 and 4 to communicate with
the clinician programmer 40 or patient programmer 50. The INS 5
comprises an INS controller 90, memory 100 and a telemetry block
80. The INS controller 90 processes instructions received at the
telemetry block 80. In the preferred embodiment, the INS controller
90 will either download or upload data to or from the INS memory
100 depending on the instructions received at the telemetry block
80. The INS memory 100 includes memory sufficient for operation of
the INS 5 and storage of all therapy programs. Those skilled in the
art will appreciate that the INS memory 100 includes memory such as
volatile Random Access Memory (RAM) such as Static RAM, nonvolatile
Read Only Memory (ROM), and Electrically Erasable Programmable Read
Only Memory (EEPROM) such as Flash EEPROM, as well as other
suitable INS memory 100. Once the personalized therapy programs
have been downloaded, upon instructions by the patient programmer
50, the INS controller 90 will be able to execute both the preset
clinician therapy programs and the personalized therapy
programs.
[0041] FIG. 4 shows a block diagram depicting a preferred method of
the present invention for a patient to create personalized therapy
programs for storage in an INS 5. In a first step 110, preset
clinician therapy programs with electrode therapy settings are
stored in the INS memory 100.
[0042] In a second step 120, the patient interactively (as
discussed previously with respect to FIG. 3) enters a request, via
the patient programmer input medium 70 and graphical display screen
60.
[0043] In a third step 130, the preset clinician therapy programs
have been accessed and are displayed on the patient programmer
graphical display screen 60 and stored in the patient programmer
memory 75.
[0044] In step four 140, the patient creates personalized therapy
programs, with personalized therapy settings (discussed in FIG. 5),
by modifying the accessed preset clinician therapy programs. The
personalized therapy programs are created through interaction (as
discussed previously with respect to FIG. 3) with the patient
programmer 50, via the patient programmer input device 70 and
graphical display screen 60.
[0045] In step five 145, the patient will label the created
personalized therapy programs in preparation for saving or
storing.
[0046] In step six 150, the patient stores the new personalized
therapy programs with personalized therapy settings in the INS
memory 100, under the particular labels chosen by the patient.
Storing is accomplished through interactive manipulation (as
discussed previously with respect to FIG. 3) of the patient
programmer 50 by the patient. Once the patient requests that the
new programs be stored, the patient programmer 50 will download the
newly created personalized therapy programs to the INS memory 100,
via telemetry communication 4. The INS device 5 will now be able to
execute the new stored personalized therapy programs.
[0047] In step seven 160, the patient can execute select either a
preset clinician therapy program or a personalized therapy program
in accordance with the patient's activity and/or preference.
[0048] FIG. 5 depicts a block diagram representation showing, in
more detail, steps executed by the patient to create personalized
therapy programs from preset therapy programs already present in
the INS 5. As discussed previously, physician defined programs or
preset clinician therapy programs (PCTP) 170 are created on a
clinician programmer 40 (shown in FIG. 3) and downloaded via
telemetry 3 and stored (shown in FIG. 3) in the INS memory 100. At
the patient's discretion, a patient can access the PCTPs via a
patient programmer 70. The patient can then build or create
personalized activity sets or personalized therapy programs
190.
[0049] Typically, there is more than one PCTP 170 downloaded and
stored in the INS memory 100. FIG. 5 shows that there are N number
of PCTPs 170 stored in INS memory 100 each labeled P1, P2, P3, P4,
. . . PN. Further, each PCTP 170, includes particular Preset
Clinician Therapy Setting (PCTS) 180 such as stimulation amplitude,
rate, pulse width, electrode polarities, and directional sequence.
As result, each of the PCTPs 170 labeled P1, P2, P3, P4, . . . PN
have their own corresponding set of PCTS 180 (Amplitude1, Rate1,
PW1; Amplitude2, Rate2, PW2; Amplitude3, Rate3, PW3; . . .
AmplitudeN, RateN, PWN). The patient will in turn create his/her
own personalized therapy programs 190 with corresponding
personalized therapy settings 200 from the available N number of
PCTPs 170 stored in the INS memory 100.
[0050] The patient, however, has flexibility in creating his/her
personalized therapy programs 190 and settings 200. In a first
case, the patient can access a single PCTP 170 (e.g., P1) and build
or create a personalized therapy program 170 with corresponding
personalized settings 200 by adjusting or modifying the PCTS 180
(i.e., Amplitude1, Rate1, PW1) of that single accessed PCTP 170.
Having created a personalized therapy program 190, the patient will
then define or label the new personalized therapy program 190.
[0051] Alternatively, in a second case shown in FIG. 5, the patient
can access any two PCTPs 170 (e.g., P1 and P2) to build or create a
new personalized therapy program 190. In this case, the patient
could decide to make no modifications to the PCTS 180 (i.e.
Amplitude1, Rate1, PW1 and Amplitude2, Rate2, PW2) of the chosen
PCTPs 170 and simply have this personalized therapy program 190 be
a combination of the two chosen PCTPs 170 with their PCTS 180
unmodified. This case is shown by the personalized therapy program
190 labeled "Sleep" 210.
[0052] In a third case, as shown in FIG. 5, the patient can access
any two PCTPs 170 (e.g., P1 and P3) to build or create a new
personalized therapy program 170. In this case, the patient could
decide to make changes to the PCTS 180 (i.e., Amplitude1, Rate1,
PW1 and Amplitude3, Rate3, PW3) of one or both of the chosen PCTPs
170. The result would be a personalized therapy program 190 that is
a combination of the two chosen PCTPs 170 with one or both of the
PCTS 180 modified, for example as shown by the personalized therapy
program 190 labeled "Sitting" 220. The patient can create any
desired number of personalized therapy programs 190 through
repetition of the steps discussed with respect to FIGS. 3-5.
[0053] Additionally, it will be readily appreciated by those
skilled in the art that the patient could actually access any
number of PCTPs 170 (i.e., P1, P2, P3 up to PN) or all the PCTPs
170 to build or create a new personalized therapy program 170. In
such a case, the patient could make changes to any number or all of
the PCTS 180 (i.e., the Amplitude, Rate, PW) of any one or all of
the chosen PCTPs 170. The result would then be a personalized
therapy program 190 that is a combination of the chosen PCTPs 170
with some or all PCTS 180 modified.
[0054] In the preferred embodiments of the present invention,
discussed with reference to FIGS. 3-5, patient was able to access
and create personalized therapy programs 170 through the
interactive operation of a patient programmer 70. However, those
skilled in the art will readily recognize that a patient programmer
70 is only one of many component that can be used for this
function. For example, a computing device could also be used as the
medium to create and store personalized therapy programs 170.
[0055] It will also be apparent to those of skill in the art that
the arrangement and configuration of components of the present
invention is only the preferred embodiment of the present
invention. For example, those skilled in the art will readily
recognized that the present invention can also be used with an
External Neuro Stimulator (not shown), with stimulation leads that
are implanted into a patient percutaneously, a physician
programmer, and a patient programmer. The ENS functions similarly
to the INS but is not designed for implantation.
[0056] In other embodiments, the apparatus and method for patient
directed therapy management of the present invention can be used
with any number of implantable systems requiring the use of preset
therapy programs, including, but not limited to, pacemakers,
defibrillators, and cochlear implants, implantable diagnostic
devices for detecting bodily conditions of certain organs, like the
brain or the heart, and drug delivery systems having an implantable
pump.
[0057] Those skilled in that art will recognize that the preferred
embodiments may be altered or amended without departing from the
true spirit and scope of the invention. Thus, while various
alteration and permutations are possible, the invention is limited
only by the following claims and equivalents.
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