U.S. patent application number 15/293138 was filed with the patent office on 2017-02-02 for method and apparatus for indication-based programming of cardiac rhythm management devices.
The applicant listed for this patent is Cardiac Pacemakers Inc.. Invention is credited to Adam W. Cates, James O. Gilkerson, Kenneth P. Hoyme.
Application Number | 20170028209 15/293138 |
Document ID | / |
Family ID | 35997836 |
Filed Date | 2017-02-02 |
United States Patent
Application |
20170028209 |
Kind Code |
A1 |
Cates; Adam W. ; et
al. |
February 2, 2017 |
METHOD AND APPARATUS FOR INDICATION-BASED PROGRAMMING OF CARDIAC
RHYTHM MANAGEMENT DEVICES
Abstract
A cardiac rhythm management (CRM) system includes a programming
device that determines parameters for programming an implantable
medical device based on patient-specific information including
indications for use of the implantable medical device. By executing
an indication-based programming algorithm, the programming device
substantially automates the process between the diagnosis of a
patient and the programming of an implantable medical device using
parameters individually determined for that patient.
Inventors: |
Cates; Adam W.;
(Minneapolis, MN) ; Gilkerson; James O.;
(Stillwater, MN) ; Hoyme; Kenneth P.; (Plymouth,
MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Cardiac Pacemakers Inc. |
St. Paul |
MN |
US |
|
|
Family ID: |
35997836 |
Appl. No.: |
15/293138 |
Filed: |
October 13, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14255877 |
Apr 17, 2014 |
9468769 |
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15293138 |
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11831683 |
Jul 31, 2007 |
8725268 |
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14255877 |
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11110500 |
Apr 20, 2005 |
7257447 |
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11831683 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/37235 20130101;
A61N 1/37264 20130101; G16H 10/60 20180101; G16H 50/20 20180101;
A61N 1/37211 20130101; A61N 1/365 20130101; A61N 1/37254 20170801;
G16H 40/63 20180101; A61N 1/3956 20130101; G16H 40/40 20180101;
G16H 40/67 20180101; A61N 1/37247 20130101; G06F 19/3418
20130101 |
International
Class: |
A61N 1/372 20060101
A61N001/372; A61N 1/362 20060101 A61N001/362; G06F 19/00 20060101
G06F019/00; A61N 1/39 20060101 A61N001/39 |
Claims
1. An external system for programming an implantable medical
device, the system comprising: a telemetry circuit configured to
receive information from the implantable medical device; a device
identification module configured to identify the device type of the
implantable medical device using information received from the
implantable medical device via telemetry; a programming device
configured to receive patient-specific information and the
identified device type, the programming device comprising: an
operational mode selector configured to select at least one
operational mode of the implantable medical device based on the
patient-specific information and the identified device type; and a
parameter value generator configured to automatically produce
values of a set of operational parameters enabling the implantable
medical device to operate in the selected operational mode using
the patient-specific information and the identified device type;
and a display screen configured to display the values of the set of
operational parameters.
2. The system of claim 1, further comprising an election input
device configured to receive a user election to accept and a user
election to discard the values of operational parameters.
3. The system of claim 2, wherein the election input device is
further configured to receive a user election to modify the
automatically produced values of a set of operational
parameters.
4. The system of claim 3, wherein the display screen is configured
to present the user with one or more ranges encompassing one or
more operational parameter values alternative to the automatically
produced values upon receiving an election to modify the
automatically produced values, wherein the one or more alternative
operational parameter values encompassed by the one or more ranges
are within predetermined safety limits.
5. The system of claim 1, wherein the programming device is
configured to program an implantable pacemaker.
6. The system of claim 5, wherein the programming device is further
configured to program an implantable
cardioverter/defibrillator.
7. The system of claim 1, wherein the operational mode selector is
further configured to select an operational mode from a plurality
of available operational modes of the implantable medical device
based on a user selection, the operational mode selector including
a mode input configured to receive the user selection.
8. The system of claim 1, further comprising: a telecommunication
network; and one or more storage devices configured to store the
patient-specific information and including at least one storage
device coupled to the programming device via the telecommunication
network.
9. The system of claim 1, wherein the patient-specific information
comprises electronic medical records of the patient, the electronic
medical records defining a symptom or circumstance that indicates
advisability of one or more medical treatments deliverable by the
implantable medical device.
10. The system of claim 1, wherein the device type defines the set
of operational parameters.
11. A method for programming an implantable medical device for a
patient, the method comprising: receiving device-specific
information indicative of a device type of the implantable medical
device from the implantable medical device via a telemetry link;
collecting patient-specific information; selecting at least one
operational mode of the implantable medical device based on the
patient-specific information and the device specific information;
and automatically producing values of a set of operational
parameters enabling the implantable medical device to operate in
the selected operational mode by using the patient-specific
information and the device specific information.
12. The method of claim 11, further comprising programming the
implantable medical device.
13. The method of claim 12, wherein programming the implantable
medical device comprises programming at least one of the group
consisting of an implantable cardioverter/defibrillator and an
implantable pacemaker.
14. The method of claim 11, wherein collecting the patient-specific
information comprises collecting information acquired by an
outpatient system performing continuous patient monitoring.
15. The method of claim 11, wherein collecting the patient-specific
information comprises collecting information from at least one
storage device via a telecommunication network.
16. The method of claim 11, wherein selecting the operational mode
further comprises receiving a selection from a user.
17. The method of claim 11, further comprising providing a user an
option to accept and an option to discard the values of the set of
operational parameters.
18. The method of claim 11, wherein the patient specific
information comprises electronic medical records of the patient,
the electronic medical records defining a symptom or circumstance
that indicates advisability of one or more medical treatments
deliverable by the implantable medical device.
19. The method of claim 11, further comprising presenting a user
with an option to accept, modify, or discard the automatically
produced values of the set of operational parameters.
20. The method of claim 11, further comprising receiving a user
election to modify the automatically produced values; and in
response to receiving the election, presenting the user with one or
more ranges encompassing one or more alternative operational
parameter values that are within predetermined safety limits.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation of U.S. patent
application Ser. No. 14/255,877, filed Apr. 17, 2014, which is a
continuation of U.S. patent application Ser. No. 11/831,683, filed
Jul. 31, 2007, which is a continuation of U.S. patent application
Ser. No. 11/110,500, filed Apr. 20, 2005, now issued as U.S. Pat.
No. 7,257,447, each of which is hereby incorporated by reference in
its entirety.
[0002] This application is related to co-pending, commonly
assigned, U.S. patent application Ser. No. 10/950,876, entitled
"SYSTEM AND METHOD FOR DETERMINING PATIENT-SPECIFIC IMPLANTABLE
MEDICAL DEVICE PROGRAMMING PARAMETERS," filed on Sep. 27, 2004, now
issued as U.S. Pat. No. 8,285,378, and U.S. patent application Ser.
No. 10/844,642, entitled "METHOD AND APPARATUS FOR QUESTION-BASED
PROGRAMMING OF CARDIAC RHYTHM MANAGEMENT DEVICES," filed on May 13,
2004, now issued as U.S. Pat. No. 7,697,993, which are hereby
incorporated by reference in their entirety.
FIELD OF THE INVENTION
[0003] This document generally relates to cardiac rhythm management
(CRM) systems and particularly, but not by way of limitation, to a
system for programming implantable CRM devices.
BACKGROUND
[0004] Implantable CRM devices such as pacemakers and
defibrillators are used to treat cardiac arrhythmias, heart
failure, and other cardiac disorders by delivering electrical
energy to the heart. Advances in biomedical technology have
provided implantable CRM devices with increasingly sophisticated
features and operational modes treating more types of disorders
while being more adaptive to a patient's changing physiological
conditions and individual lifestyle. As a consequence, programming
an implantable CRM device is an increasingly complicated task. To
maximize the extent to which the patient can potentially benefit
from the implantable CRM device, the programming needs to be
substantially patient-specific.
[0005] To operate after implantation into a patient, an implantable
CRM device is programmed by a physician or other caregiver using an
external programming device. The programming device allows the
physician or other caregiver to program the implantable CRM device
by entering or selecting values for programmable parameters. Such
programmable parameters include, but are not limited to, therapy
modes and quantitative parameters required for operating in each
therapy mode, special features and quantitative parameters required
for utilizing each special feature, and various therapy activation
or feature activation criteria. These parameters are determined by
the physician or other caregiver for each patient based on the
patient's indications for use of the implantable CRM device as well
as other patient-specific data obtained during various diagnoses
and tests. The increasing number of programmable parameters that
accompany the increasingly sophisticated features and operational
modes makes the parameter determination increasingly difficult.
Additionally, implantable CRM devices of different types, as well
as some devices of the same type, require different programmable
parameters and/or different programming procedures. Physicians
and/or other caregivers may have to receive extensive training on
how to program each specific type of implantable CRM devices for an
individual patient and how to optimally utilize many advanced
features for the benefit of that patient. Introductions of new
device features, while providing the users with additional power in
treating cardiac disorders, tend to make the programming of
implantable CRM devices more difficult and intimidating. One
undesirable consequence is underutilization of available device
features and capabilities. If properly utilized, such underutilized
device features and capabilities will potentially provide
substantial additional benefits to many patients who have already
benefited from implantable CRM devices.
[0006] For these and other reasons, there is a need for
facilitating the process of optimally programming an implantable
CRM device for each individual patient.
SUMMARY
[0007] A CRM system includes a programming device that determines
parameters for programming an implantable medical device based on
patient-specific information including indications for use of the
implantable medical device. By executing an indication-based
programming algorithm, the programming device substantially
automates the process between the diagnosis of a patient and the
programming of an implantable medical device using parameters
individually determined for that patient.
[0008] In one embodiment, an external system for programming an
implantable medical device includes an external telemetry circuit
and an indication-based programming device. The external telemetry
circuit communicates with the implantable medical device. The
indication-based programming device includes a patient information
input, a device information input, an indication-based parameter
generation module, and a programming module. The patient
information input receives patient-specific information including
indications for use of the implantable medical device. The device
information input receives device-specific information including a
device type indicative of a plurality of programmable parameters.
The indication-based parameter generation module produces values
for a set of operational parameters of the plurality of
programmable parameters based on the patient-specific information
and the device-specific information. The programming module
programs the implantable medical device using the values of the set
of operational parameters.
[0009] In a further embodiment, a cardiac rhythm management (CRM)
system includes the external system and an implantable medical
device. The implantable medical device is identified by a device
type indicative of one or more available operational modes and a
plurality of programmable parameters.
[0010] In one embodiment, a method for programming an implantable
medical device is provided. Patient-specific information including
indications for use of the implantable medical device is collected.
Device-specific information including a device type of the
implantable medical device is received. The device type indicates
one or more available operational modes and a plurality of
programmable parameters of the implantable medical device. An
indication-based programming algorithm is executed to produce
values for a set of operational parameters of the plurality of
programmable parameters based on the patient-specific information
and the device-specific information. A user election is received to
determine whether to accept, modify, or discard the values for the
set of operational parameters.
[0011] This Summary is an overview of some of the teachings of the
present application and not intended to be an exclusive or
exhaustive treatment of the present subject matter. Further details
about the present subject matter are found in the detailed
description and appended claims. Other aspects of the invention
will be apparent to persons skilled in the art upon reading and
understanding the following detailed description and viewing the
drawings that form a part thereof. The scope of the present
invention is defined by the appended claims and their legal
equivalents.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] In the drawings, which are for illustrative purposes only
and not necessarily drawn to scale, like numerals describe similar
components throughout the several views. The drawings illustrate
generally, by way of example, various embodiments discussed in the
present document.
[0013] FIG. 1 is an illustration of an embodiment of a CRM system
and portions of the environment in which the CRM system is
used.
[0014] FIG. 2 is a block diagram illustrating an embodiment of
portions of the circuit of an external system performing
indication-based programming of an implantable medical device.
[0015] FIG. 3 is a block diagram illustrating a specific embodiment
of portions of the circuit of the external system.
[0016] FIG. 4 is a block diagram illustrating an embodiment of the
external system.
[0017] FIG. 5 is a flow chart illustrating an embodiment of a
method for indication-based programming of an implantable medical
device.
[0018] FIG. 6 is a flow chart illustrating a specific embodiment of
the method for indication-based programming of the implantable
medical device.
DETAILED DESCRIPTION
[0019] In the following detailed description, reference is made to
the accompanying drawings that form a part hereof, and in which is
shown by way of illustration specific embodiments in which the
invention may be practiced. These embodiments are described in
sufficient detail to enable those skilled in the art to practice
the invention, and it is to be understood that the embodiments may
be combined, or that other embodiments may be utilized and that
structural, logical and electrical changes may be made without
departing from the scope of the present invention. The following
detailed description provides examples, and the scope of the
present invention is defined by the appended claims and their legal
equivalents.
[0020] It should be noted that references to "an", "one", or
"various" embodiments in this document are not necessarily to the
same embodiment, and such references contemplate more than one
embodiment.
[0021] In this document, an "indication" includes a symptom or
particular circumstance that indicates the advisability or
necessity of a specific medical treatment or procedure. An
"indication for use of an implantable medical device" or "device
indication" includes a symptom or particular circumstance that
indicates the advisability or necessity of one or more specific
medical treatments that are deliverable by an implantable medical
device or one or more specific medical procedures that are
performable by the implantable medical device.
[0022] This document discusses an indication-based programming
method and programming device for an implantable medical device.
The programming device collects patient-specific information
including a patient's indications for use of the implantable
medical device and automatically produces values for operational
parameters enabling the implantable medical device to deliver one
or more therapies according to the indications. In addition to the
indications, the patient-specific information includes, but is not
limited to, the patient's demographic data, cardiac history,
electrogram, electrocardiogram (ECG), echocardiogram (indicative of
ejection fraction, for example), physical attributes, non-cardiac
disease history, and/or drug regimens. Further examples of such
patient-specific information and an example of a system for
determining patient-specific parameters for programming an
implantable medical device are discussed in U.S. patent application
Ser. No. 10/950,876, entitled "SYSTEM AND METHOD FOR DETERMINING
PATIENT-SPECIFIC IMPLANTABLE MEDICAL DEVICE PROGRAMMING
PARAMETERS," filed on Sep. 27, 2004, assigned to Cardiac
Pacemakers, Inc., which is incorporated herein by reference in its
entirety. The patient-specific information allows for optimization
of therapy delivery for each individual patient. The values for the
operational parameters produced by the programming device are then
used to program the implantable medical device via telemetry. Thus,
the programming device substantially automates the process between
the diagnosis of the patient's indications and other conditions and
the programming of the implantable medical device. The
indication-based programming allows a user, such as a physician or
other caregiver, to optimally utilize features and capabilities of
an implantable medical device based on the patient's specific
conditions.
[0023] FIG. 1 is an illustration of an embodiment of a CRM system
100 and portions of the environment in which CRM system 100 is
used. System 100 includes an implantable medical device 110, a lead
system 108, an external system 120, and a wireless telemetry link
115.
[0024] After implantation, implantable medical device 110 operates
within a body 102 to sense activities of a heart 105 and deliver
one or more therapies to heart 105. Implantable medical device 110
includes, but is not limited to, one or more of a pacemaker, a
cardioverter/defibrillator, a cardiac resynchronization therapy
(CRT) device, a cardiac remodeling control therapy (RCT) device, a
drug delivery device, and a biological therapy device. A device
type, such as a model number or a code that identifies the type of
implantable medical device 110, indicates one or more available
operational modes and a plurality of programmable parameters of
implantable medical device 110. Each operational mode provides for
one type of therapy deliverable by implantable medical device 110.
In one embodiment, implantable medical device 110 is an implantable
cardioverter/defibrillator with pacing capabilities and providing
for operational modes including a bradycardia pacing mode, a CRT
pacing mode, an RCT pacing mode, an anti-tachycardia pacing mode,
and a defibrillation mode. Some or all of such operational modes
are further differentiated into specific operational modes. For
example, the bradycardia pacing mode includes standard pacing modes
known in the art, such as the AOO, VOO, AAI, VVI, VVT, DVI, DDI,
VDD, and DDD pacing modes and the rate-adaptive versions of these
pacing modes. Each operational mode is associated with a plurality
of operational parameters. Values for a set of operational
parameters are programmed into implantable medical device 110 for
it to operate in one or more operational modes selected according
to a patient's conditions and therapeutic needs.
[0025] Lead system 108 provides one or more electrical and/or other
connections between implantable medical device 110 and heart 105.
In one embodiment, lead system 108 includes one or more pacing
and/or defibrillation leads each having one or more electrodes for
electrogram sensing and/or delivery of electrical pulses including
pacing pulses and/or cardioversion/defibrillation pulses to heart
105. In one embodiment, one or more intracardiac sensors are
incorporated into lead system 108 to sense signals such as heart
sounds, intracardiac pressures, and chemical parameters of the
blood.
[0026] External system 120 communicates with implantable medical
device 110 through telemetry link 115. It allows the user and/or
the patient to communicate with implantable medical device 110.
External system 120 includes an indication-based programming device
130 that performs indication-based programming of implantable
medical device 110. In addition to an indication-based programming
mode, external system 120 also provides for a parameter-based
programming mode. When operating in the indication-based
programming mode, indication-based programming device 130 collects
patient-specific information and produces the values for the set of
operational parameters for programming implantable medical device
110 to operate in one or more of its available operational modes
based on the patient-specific information. When operating in the
parameter-based programming mode, external system 120 presents
parameters used in its one or more current operational modes with
their current values and allows the user to adjust the current
values. In one embodiment, in addition to the indication-based
programming mode and the parameter-based programming mode, external
system 120 further provides for a question-based programming mode.
When operating in the question-based programming mode, external
system 120 asks the user a sequence of questions. Based on at least
the answers to these questions, external system 120 determines the
values for the set of operational parameters for programming
implantable medical device 110 to operate in one or more of its
operational modes. An example of the question-based programming is
discussed in U.S. patent application Ser. No. 10/844,642, "METHOD
AND APPARATUS FOR QUESTION-BASED PROGRAMMING OF CARDIAC RHYTHM
MANAGEMENT DEVICES," filed on May 13, 2004, assigned to Cardiac
Pacemakers, Inc., which is incorporated herein by reference in its
entirety.
[0027] For illustrative purposes, specific embodiments of external
system 120 are discussed below with reference to FIGS. 2-4. In a
specific embodiment, external system 120 includes portions of a
system for determining patient-specific implantable medical device
programming parameters that is discussed in U.S. patent application
Ser. No. 10/950,876.
[0028] Telemetry link 115 provides for data transmissions between
implantable medical device 110 and external system 120. In one
embodiment, telemetry link 115 is an inductive (magnetic) telemetry
link. In another embodiment, telemetry link 115 is a far-field
radio-frequency electromagnetic telemetry link. In various other
embodiments, telemetry link 115 uses other types of media suitable
for wireless data transmissions between an implantable medical
device and an external system 120, such as ultrasound. Telemetry
link 115 provides for data transmission from implantable medical
device 110 to external system 120. This includes, for example,
transmitting information indicative of the device type of
implantable medical device 110, transmitting data indicative of the
current operational mode(s) and parameter values, transmitting
real-time physiological data acquired by implantable medical device
110, extracting physiological data acquired by and stored in
implantable medical device 110, extracting therapy history data,
and/or extracting data indicating an operational status (e.g.,
battery status and lead impedance). The physiological data
represent signals acquired by implantable medical device 110 using
one or more sensors included in, and/or connected to, implantable
medical device 110. In one embodiment, one or more such sensors are
incorporated into lead system 108. The signals include, but not
being limited to, one or more of electrograms, heart sounds or a
signal indicative of heart sounds, activity level signal, impedance
signal, pressure or pressure-indicating signal, and respiratory
signal. In one embodiment, the physiological data also include
parameters measured from one or more of these signals. In one
embodiment, external system 120 or the user determines parameter
values for programming implantable medical device 110 based on
these physiological data. Telemetry link 115 also provides for data
transmission from external system 120 to implantable medical device
110. This includes, for example, parameters for programming
implantable medical device 110 to operate in one or more of its
available operational modes and to perform at least one
self-diagnostic test (such as for a battery status or a lead
impedance value).
[0029] FIG. 2 is a block diagram illustrating an embodiment of
portions of the circuit of an external system 220, which is a
specific embodiment of external system 120. External system 220
includes an external telemetry circuit 222 and an indication-based
programming device 230. External telemetry circuit 222 communicates
with implantable medical device 110 via telemetry link 115.
[0030] Indication-based programming device 230 is a specific
embodiment of indication-based programming device 130 and includes
a patient information input 236, a device information input 238, an
indication-based parameter generation module 234, and a programming
module 232. Patient information input 236 receives patient-specific
information including indications for use of the implantable
medical device. In various embodiments, patient information input
236 receives patient-specific information from one or more of
implantable medical device 110, another one or more implantable
devices implanted in the patient, sensors externally attached to
the patient, a physician or other caregiver through a user
interface of external system 220, electronic medical records of the
patient stored in one or more locations in external system 220, and
any relevant records made available to external system 220. Device
information input 238 receives device-specific information
including a device type indicative of a plurality of programmable
parameters. In various embodiments, device information input 238
receives device-specific information from implantable medical
device 110 and/or one or more locations in external system 220.
Indication-based parameter generation module 234 produces values
for a set of operational parameters of the plurality of
programmable parameters based on the patient-specific information
and the device-specific information. Programming module 232
programs the implantable medical device by converting the values
for the set of operational parameters into a programming code and
causing external telemetry circuit 222 to transmit the programming
code to implantable medical device 110 via telemetry link 115.
[0031] FIG. 3 is a block diagram illustrating an embodiment of
portions of the circuit of an external system 320, which is a
specific embodiment of external system 220. External system 320
includes external telemetry circuit 222, an indication-based
programming device 330, a device identification module 344, a
patient information storage system 346, a device information
storage device 350, and a user interface 352.
[0032] Indication-based programming device 330 is a specific
embodiment of indication-based programming device 230 and includes
patient information input 236, device information input 238, an
indication-based parameter generation module 334, and programming
module 232. Indication-based parameter generation module 334 is a
specific embodiment of indication-based parameter generation module
234 and produces values for the set of operational parameters based
on the patient-specific information and the device-specific
information. The set of operational parameters enables the
implantable medical device to operate in at least one of its
available operational modes. In one embodiment, as illustrated in
FIG. 3, indication-based parameter generation module 334 includes
an operational mode selector 342 and a parameter value generator
340. Operational mode selector 342 selects at least one operational
mode from the available operational modes of implantable medical
device 110. In one embodiment, operational mode selector 342
selects the operational mode(s) based on the patient-specific
information and the device-specific information. In another
embodiment, operational mode selector 342 selects the operational
mode(s) based on a user selection and includes a mode input to
receive the user selection. Parameter value generator 340 produces
the values of the set of operational parameters enabling
implantable medical device 110 to operate in the selected
operational mode(s) based on the patient-specific information and
the device-specific information. In another embodiment,
indication-based parameter generation module 334 includes an
indication-based programming algorithm execution module such as a
mapping algorithm execution module to execute a mapping algorithm
relating the patient-specific information to the device-specific
information.
[0033] Device identification module 344 identifies the device type
of implantable medical device 110 based on information received by
external telemetry circuit 222 from implantable medical device 110.
The device type indicates the available operational modes and the
programmable parameters of implantable medical device 110. In one
embodiment, device identification module 344 includes a device
model identification module to identify a model number indicative
of the device type. In another embodiment, device identification
module 344 includes a device code identification module to identify
a device code indicative of the device type.
[0034] Patient information storage system 346 includes one or more
storage devices 348 to store patient-specific information
including, but not being limited to, some or all of indications for
use of the implantable medical device, demographic data, cardiac
history, electrogram, ECG, physical attributes, non-cardiac disease
history, and drug regimens. In one embodiment, the patient-specific
information is stored as electronic medical records. In one
embodiment, the patient-specific information includes information
acquired by an outpatient system performing continuous monitoring,
diagnostic, and patient management functions including continuous
ECG monitoring and analysis. Such a system allows continuous signal
acquisition and/or analysis for a relatively long period of time,
such as 24 hours or longer. One example of such a system includes a
Holter monitor, which is known in the art as a portable device worn
by a patient during the course of daily activities for continuously
recording cardiac electrical activity of the patient. Another
example of such a system is an outpatient mobile telemetry system
providing for ECG monitoring and analysis used by CardioNet (San
Diego, Calif.) to provide monitoring and patient management
services.
[0035] Device information storage device 350 stores the
device-specific information. In one embodiment, device information
storage device 350 stores device information data sets each
specific to one type of implantable medical devices programmable by
external system 320. The stored device-specific information is
updated when additional information is made available, such as when
a new way of using an existing implantable medical device is
developed. In one embodiment, when external system 320 receives
additional and/or modified device information data for an existing
type implantable medical device, the device information data set
stored in device information storage device 350 for that existing
type implantable medical device is updated accordingly.
[0036] In one embodiment, upon establishment of telemetry link 115,
device identification module 344 identifies the device type of
implantable medical device 110, and the device-specific information
is extracted from device information storage device 350 according
to the identified device type. Device information input 238 then
receives the extracted device-specific information.
[0037] User interface device 352 includes a presentation device 355
and a user input device 358. Presentation device 355 includes a
display screen 354. Display screen 354 includes a parameter field
356 to display the values for the set of operational parameters. In
one embodiment, presentation device 355 further includes a printer
to print information including the values for the set of
operational parameters. User input device 358 includes a
programming mode switch 360, an election input device 364, a
parameter input device 362, and a programming command input 368.
Programming mode switch 360 allows the user to select the
indication-based programming mode or the parameter-based
programming mode. In one embodiment, programming mode switch 360
allows the user to switch between the indication-based programming
mode and the parameter-based programming mode during a programming
process. Election input device 364 allows the user to accept,
modify, or discard the values for the set of operational
parameters. Parameter input device 362 allows the user to modify
one or more of the values for the set of operational parameters if
the user has elected to modify the values. Programming command
input 368 allows the user to enter a command for programming the
implantable medical device using the values for the set of
operational parameters. In one embodiment, display screen 354 is an
interactive screen that is part of user input device 358.
Programming mode switch 360 includes a programming mode change
button displayed on the interactive screen. Election input device
364 includes election buttons displayed on the interactive screen.
Parameter field 356 is an interactive parameter field being part of
parameter input device 362. The interactive parameter field allows
modification of the displayed values for the set of operational
parameters. Programming command input 368 includes a programming
mode change button displayed on the interactive screen. In another
embodiment, one or more of programming mode switch 360, election
input device 364, parameter input device 362, and programming
command input 368 includes part of display screen 354, which is an
interactive screen, while the remaining input device(s) include
switches, keys, knobs, and/or other mechanical devices. In another
embodiment, programming mode switch 360, election input device 364,
parameter input device 362, and programming command input 368 each
include one or more switches, keys, knobs, and/or other mechanical
devices.
[0038] FIG. 4 is a block diagram illustrating an embodiment of
external system 420. External system 420 is a specific embodiment
of external system 120 and, in one embodiment, represents an
exemplary structural arrangement for external system 220 or 320. As
illustrated in FIG. 4, external system 420 is a patient management
system including an external device 370, a telecommunication
network 372, and one or more remote devices 374. External device
370 is placed within the vicinity of implantable medical device 110
and communicates with implantable medical device 110 via telemetry
link 115. Remote device(s) 374 are in one or more remote locations
and communicates with external device 370 through telecommunication
network 372, thus allowing the user to monitor and treat the
patient from a distant location and/or allowing collection of
patient information from the one or more remote locations. In one
specific embodiment, external device 370 includes indication-based
programming device 130 (including any of its specific embodiment).
In another specific embodiment, remote device(s) 374 include
indication-based programming device 130 (including any of its
specific embodiment). In another embodiment, indication-based
programming device 130 (including any of its specific embodiments)
is distributed in both external device 370 and remote device(s)
374.
[0039] Telecommunication network 372 allows for communication
between an operation room, an electrophysiology laboratory, or
other facility where implantable medical device 110 is programmed
and one or more remote data storage facilities where the
patient-specific information is located. In one embodiment,
external system 420 is used during an implantation operation.
External device 370 is placed in or near an operation room where
implantable medical device 110 is implanted into a patient. Remote
device(s) 374 include a data base containing the patient's
electronic medical records. Communication between external device
370 and the data base is established to allow indication-based
programming device 130 to collect patient-specific information from
the patient's electronic medical records. Indication-based
programming device 130 then generates a programming code including
parameter values required for implantable medical device 110 to
deliver one or more therapies approximately optimized based on the
patient-specific information. Thus, external system 420 provides
for a substantially automated process for programming implantable
medical device 110 during the implantation operation.
[0040] FIG. 5 is a flow chart illustrating an embodiment of a
method for an indication-based programming of an implantable
medical device. The method substantially automates the process
between the diagnosis of a patient and the programming of the
implantable medical device if the patient is indicated for a device
therapy as the result of the diagnosis. In one embodiment, the
method is performed with external system 220.
[0041] Patient-specific information is collected at 500. The
patient-specific information includes indications for use of the
implantable medical device. An indication-based automatic
programming algorithm is executed at 510 to produce values for a
set of operational parameters based on the patient-specific
information. The set of operational parameters enables the
implantable medical device to deliver one or more therapies
treating the patient's indications. The implantable medical device
is programmed using the values for the set of operational
parameters at 520. In one embodiment, the implantable device is
automatically programmed after the values for the set of
operational parameters are produced. In another embodiment, after
the values for the set of operational parameters are produced, the
user reviews the values, modifies the values when appropriate or
necessary, and the implantable medical device is then
programmed.
[0042] FIG. 6 is a flow chart illustrating a specific embodiment of
the method for the indication-based programming of the implantable
medical device. In one embodiment, the method is performed with
external system 320. The implantable medical device includes, but
is not limited to, a pacemaker, a cardioverter/defibrillator, a CRT
device, and an RCT device.
[0043] Patient-specific information is collected at 600. In one
embodiment, the patient-specific information includes indications
for use of the implantable medical device. In a further embodiment,
in addition to the indications for use of the implantable medical
device, the patient-specific information includes one or more of
demographic data, cardiac history, electrogram, ECG,
echocardiogram, physical attributes, non-cardiac disease history,
and drug regimens. In one embodiment, collecting the
patient-specific information includes extracting information from
an electronic medical record. In one embodiment, collecting the
patient-specific information includes extracting information from
results of one or more electrophysiological tests. In one
embodiment, collecting the patient-specific information includes
extracting information from the implantable medical device.
[0044] Device-specific information is received at 610. The
device-specific information includes a device type of the
implantable medical device. The device type indicates the available
operational modes and the programmable parameters of the
implantable medical device. Each operational mode is supported by a
set of operational parameters including one or more of the
programmable parameters.
[0045] An indication-based programming algorithm is executed at 620
to produce values for the set of operational parameters based on
the patient-specific information and the device-specific
information. In one embodiment, the indication-based programming
algorithm automatically selects one or more operational modes from
the available operational modes of the implantable medical device
based on the patient-specific information and the device-specific
information. The values for the set of operational parameters are
then produced to enable the implantable medical device to operate
in the automatically selected operational mode(s). In another
embodiment, the user selects one or more operational modes from the
available operational modes of the implantable medical device based
on the patient-specific information, the device-specific
information, and professional judgment. The values for the set of
operational parameters are then produced to enable the implantable
medical device to operate in the user-selected operational mode(s).
In one embodiment, the indication-based programming algorithm is a
mapping algorithm relating the patient-specific information to the
device-specific information of the implantable medical device. The
mapping algorithm selects one or more operational modes from the
available operational modes of the implantable medical device
and/or produces the values for the set of operational parameters
enabling the implantable medical device to operate in the selected
operational mode(s).
[0046] A user election regarding the handling of the values for the
set of operational parameters is received at 630. In one
embodiment, the values for the set of operational parameters are
presented to the user for review. The user is then asked to elect
to accept, modify, or discard the values for the set of operational
parameters. If an election to accept the values for the set of
operational parameters is received at 640, the implantable medical
device is programmed using the values for the set of operational
parameters at 660. If an election to modify the values for the set
of operational parameters is received at 640, one or more modified
values for the set of operational parameters are received at 650.
In one embodiment, the received one or more modified values are
checked against one or more predetermined safety limits. If any
modified value for an operational parameter exceeds the
predetermined safety limit for that parameter, the user is asked to
reenter the value for that parameter. In another embodiment, the
one or more modified values are entered by selecting values and/or
value ranges presented to the user. The presented values and/or
value ranges are within the predetermined safety limits. Then, the
implantable medical device is programmed using the one or more
modified values for the set of operational parameters at 660. If an
election to discard the values for the set of operational
parameters is received at 640, a new programming process is started
at 670. The user may, for example, choose to repeat the steps
starting at 600 after making additional and/or alternative
patient-specific information available for collection. The user may
also choose to switch to the parameter-based programming mode or
the question-based programming mode.
[0047] In one exemplary application of the indication-based
programming, a patient's electronic medical record is reviewed to
determine whether the patient is indicated for use of an
implantable cardioverter/defibrillator (ICD) based on criteria
developed from results of a clinical study with a patient
population. Examples of such a clinical study are discussed in
Prystowsky, "A Guide to Device Selection: Cardiac Resynchronization
Therapy Alone or in Combination with an Implantable Cardioverter
Defibrillator," Rev. Cardiovasc. Med., 2003; 4(Suppl 2): (S47-S54).
The ICD is capable of delivering pacing and
cardioversion/defibrillation therapies. If the patient is indicated
for both ventricular defibrillation therapy and anti-tachycardia
pacing (ATP) therapy, data from an electrophysiology test and
Holter recordings are analyzed. The analysis results in, among
other things, a threshold heart rate above which the ventricular
defibrillation therapy is to be immediately delivered and another
threshold heart rate above which an ATP therapy is to be delivered.
The analysis may also result in information related to the
morphological features of an electrogram associated with a known
cardiac rhythm for purposes of discrimination between various types
of arrhythmia. The discrimination leads to classification of a
tachyarrhythmia, and an appropriate therapy is delivered according
to the classification. If the electronic medical records further
indicate that the patient has a family history of syncope, a
monitoring zone is set at lower heart rates to capture episodes of
slow ventricular tachycardia in order to determine whether the
syncope is cardiac mediated.
[0048] It is to be understood that the above detailed description
is intended to be illustrative, and not restrictive. For example,
while a CRM system is specifically discussed in the description
above, the present subject matter is generally applicable to
various types of medical device systems. Other embodiments will be
apparent to those of skill in the art upon reading and
understanding the above description. The scope of the invention
should, therefore, be determined with reference to the appended
claims, along with the full scope of equivalents to which such
claims are entitled.
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