U.S. patent application number 09/740127 was filed with the patent office on 2002-02-28 for method and a system for using implanted medical device data for accessing therapies.
Invention is credited to Hess, Michael F., Mahoney, Patrick M., Mehra, Rahul, Owens, Clifton W., Pool, Nancy Perry, Riff, Kenneth M., Sheth, Nirav V., Ujhelyi, Michael R..
Application Number | 20020026223 09/740127 |
Document ID | / |
Family ID | 22630370 |
Filed Date | 2002-02-28 |
United States Patent
Application |
20020026223 |
Kind Code |
A1 |
Riff, Kenneth M. ; et
al. |
February 28, 2002 |
Method and a system for using implanted medical device data for
accessing therapies
Abstract
A method and system facilitates the access by a patient of
implanted medical device related data for patient participation in
their own clinical care and therapy. In an example embodiment, the
method includes establishing a communications link between an
implanted medical device and a data processor via an implanted
medical device interface. Access to a secured database is obtained
via the implanted device data processor using a set of patient
identification data. A query is then submitted via the data
processor to the secured database in response to input patient
diagnostic data. Data received from the secured database is then
displayed for use in a patient evaluation.
Inventors: |
Riff, Kenneth M.; (Orono,
MN) ; Mahoney, Patrick M.; (Maple Grove, MN) ;
Owens, Clifton W.; (Minnetonka, MN) ; Mehra,
Rahul; (Stillwater, MN) ; Hess, Michael F.;
(Minneapolis, MN) ; Sheth, Nirav V.; (Coon Rapids,
MN) ; Pool, Nancy Perry; (Minnetonka, MN) ;
Ujhelyi, Michael R.; (Maple Grove, MN) |
Correspondence
Address: |
GIRMA WOLDE-MICHAEL
Medtronic, Inc., MS 301
7000 Central Avenue NE
Minneapolis
MN
55432
US
|
Family ID: |
22630370 |
Appl. No.: |
09/740127 |
Filed: |
December 18, 2000 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60173062 |
Dec 24, 1999 |
|
|
|
Current U.S.
Class: |
607/27 |
Current CPC
Class: |
A61B 5/0031 20130101;
G16H 10/60 20180101; G16H 40/63 20180101; G16H 15/00 20180101; A61N
1/37252 20130101; A61N 1/37258 20130101; G16H 40/67 20180101; A61N
1/37254 20170801 |
Class at
Publication: |
607/27 |
International
Class: |
A61N 001/37 |
Claims
We claim:
1. A method for accessing implanted medical device for patient
alert and therapy dispensation data comprising: establishing a
communications link between an implanted medical device and a data
processor via an implanted medical device interface; obtaining
access to a secured database via the data processor using a set of
patient identification data; submitting via the data processor a
query to the secured database in response to input patient
diagnostic data; and displaying the data received from the secured
database for use in a patient evaluation.
2. The method of claim 1, wherein the step of submitting the query
includes the step of: detecting via the data processor at least one
of a plurality of predefined conditions of the patient's implanted
medical device; and generating a data response as a function of the
detected conditions.
3. The method of claim 2, wherein the step of detecting a condition
includes the steps of: performing an uplink transmission of a set
of patient diagnostic data from the implanted medical device to the
data processor; and processing the patient diagnostic data to
detect at least one of the plurality of conditions.
4. The method of claim 2, further comprising the steps of:
notifying the patient via the data processor of the detected
condition; monitoring the implanted medical device; and displaying
a first implanted medical device status.
5. The method of claim 4, further comprising: displaying a first
set of treatment options as a function of the first implanted
medical device status and of the patient notification; and
exercising at least one of the treatment options.
6. The method of claim 5, wherein displaying treatment options
includes displaying at least one medical option along with a time
interval for exercising the displayed option.
7. The method of claim 5, wherein the treatment options are
selected from the group consisting of: medication, electrical
impulse from the implanted medical device, and a request for
medical assistance.
8. The method of claim 5, further comprising the step of notifying
the data processor of the exercised treatment option.
9. The method of claim 8, further comprising the steps of:
monitoring the implanted device continuously after notification of
exercise of the displayed option; and notifying the patient of a
second medical device status and of a second set of treatment
options, the second set of treatment options being a function of
the exercised option and the second medical device status.
10. The method of claim 4, further comprising the step of
reconfiguring patient notification of the detected condition such
that the patient notification is responsive to a second plurality
of conditions.
11. The method of claim 1, wherein obtaining access to the secured
database includes obtaining access to a remotely located secured
database via a communications network.
12. The method of claim 1, wherein input patient diagnostic data
includes an IMD patient request for information from the secured
database.
13 The method of claim 1, wherein the step of establishing a
communications link includes automatically retrieving the set of
patient identification data from the IMD.
14. The method of claim 8, further comprising the step of
reconfiguring the treatment options as a function of the exercised
option and the IMD status.
15. A system for accessing implanted medical device data
comprising: means for establishing a communications link between an
implanted medical device and a data processor via an implanted
medical device interface; means for obtaining access to a secured
database via the data processor using a set of patient
identification data; means for submitting via the data processor a
query to the secured database in response to input patient
diagnostic data; and means for displaying the data received from
the secured database for use in a patient evaluation.
16. The system of claim 15, wherein said display means includes an
LCD, CRT and an LED screen adapted to display the data
received.
17. The system of claim 15, wherein the set of patient
identification data includes an implanted medical device serial
number.
18. The system of claim 15, wherein the data received from the
secured database includes a set of implanted medical device
treatment options.
19. The system of claim 18, further comprising means for notifying
a patient of the detection of a heart condition at the implanted
medical device coupled to the data processor and display means, the
data processor configured and arranged to receive notification of
an exercise of a treatment option.
20. A system of claim 19, wherein the data processor is adapted to
reconfigure the treatment options as a function of the exercised
option and the IMD status.
21. A method for accessing implanted medical device data
comprising: establishing a communications link between an implanted
medical device and a data processor via an implanted medical device
interface; obtaining access to a secured database via the data
processor using a set of patient identification data; transmitting
a set of patient diagnostic data from the implanted medical device
to the data processor; submitting via the data processor a query to
the secured database in response to detecting a condition at the
implanted medical device from the patient diagnostic data; and
displaying the data received from the secured database for use in a
patient evaluation.
22. The method of claim 21, wherein the step of submitting the
query includes the step of: detecting via the data processor at
least one of a plurality of predefined conditions of the patient's
implanted medical device; and generating a data response as a
function of the detected conditions.
23. The method of claim 22, further comprising the steps of:
notifying the patient via the data processor of the detected
condition; monitoring the implanted medical device; and displaying
a first implanted medical device status.
24. The method of claim 23, further comprising the steps of:
displaying a first set of treatment options as a function of the
first implanted medical device status; exercising at least one of
the treatment options; notifying the data processor of the
exercised treatment option; monitoring continuously the implanted
device; and notifying the patient of a second medical device status
and of a second set of treatment options, the second set of
treatment options being a function of the exercised option and the
second medical device status.
25. A method for accessing implanted medical device data
comprising: establishing a communications link between an implanted
medical device and a data processor via an implanted medical device
interface; obtaining access to a secured database provided via the
data processor using a set of patient identification data;
transmitting a set of patient diagnostic data from the implanted
medical device to the data processor; generating a set of formatted
data via the data processor using the patient diagnostic data as a
function of a data request from the patient; and displaying the set
of formatted data received from the secured database via the data
processor for use in a patient evaluation.
26. A method of claim 25, wherein generating the formatted data
includes extracting a set of historical patient diagnostic data
from the secured database.
27. The method of claim 26, further comprising the step of using
the communications link between the implanted medical device and
the data processor to address a patient query on the formatted data
after the formatted data has been displayed.
28. The method of claim 26, further comprising the step of
establishing a communications link with a patient having the
implanted medical device to provide an interactive exchange of
information with a data processing center located remote from the
patient.
29. The method of claim 25, wherein the step of generating the
formatted data includes the step of formatting the patient
diagnostic data to illustrate a trend.
30. A system for accessing implanted medical device data
comprising: means for establishing a communications link between an
implanted medical device and a data processor via an implanted
medical device interface; means for obtaining access to a secured
database via the data processor using a set of patient
identification data; means for transmitting a set of patient
diagnostic data from the implanted medical device to the data
processor; means for generating a set of formatted data via the
data processor using the patient diagnostic data as a function of a
data request from the patient; and means for displaying the set of
formatted data from the implanted medical data processor for use in
a patient evaluation.
31. A system for accessing implanted medical device data
comprising: means for establishing a communications link between an
implanted medical device and a data processor via an implanted
medical device interface; means for obtaining access to a secured
database via the data processor using a set of patient
identification data; means for transmitting a set of patient
diagnostic data from the implanted medical device to the data
processor; means for submitting via the data processor a query to
the secured database in response to detecting a condition at the
implanted medical device from the patient diagnostic data; and
means for displaying the data received from the secured database
for use in a patient evaluation.
Description
RELATED PATENT DOCUMENTS
[0001] This application claims priority of U.S. Provisional
Application Serial No. 60/173,062, filed on Dec. 24, 1999 (P-8857),
entitled "Chronic Real-Time Information Management Systems for
Implantable Medical Devices (IMDs)." The specification and drawings
of the Provisional application are specifically incorporated herein
in its entirety.
FIELD OF THE INVENTION
[0002] The present invention generally relates to a method and a
system for using implanted medical device data to access medical
data processing systems. Specifically, the invention relates to a
method and a system for remotely accessing medical data processing
systems adapted to provide implanted device therapies in response
to patient diagnostic data received from an implanted medical
device.
BACKGROUND OF THE INVENTION
[0003] In recent years, implantable medical device technology has
rapidly advanced. Sizes and weights have decreased, while
functionality has increased. These advances have created a
corresponding demand for two-way communication between the
implantable medical device and an external device, for example, a
programmer device. In a pacemaker system, for example, a programmer
device downloads to an implanted pacemaker data such as operating
parameters. Likewise, data may flow from the implanted device to
the programmer device. Modern pacemakers are capable of storing
significant amounts of data about the patient, for example,
physiological data such as electrocardiogram (EGM), and information
pertaining to the pacemaker itself, for example, battery voltage
level. This data may need to be transmitted to the programmer
device for evaluation by a physician.
[0004] Currently implanted medical device programmers typically
include an extendible head portion that includes an antenna. The
antenna is connected to other circuitry in the programmer device
via a stretchable coil cable. Thus, the head portion can be
positioned over the patient's implanted device site for programming
or telemetry interrogation of the implanted device. Command
instructions or data that are downloaded to the implanted device
are referred to as downlink transmissions, and data transmitted
from the implanted device to the programmer device are referred to
as uplink transmissions.
[0005] A technology-based health care system that fully integrates
the technical and social aspects of patient care and therapy should
be able to flawlessly connect the patient with care providers
irrespective of separation distance or location of the
participants. While clinicians will continue to treat patients in
accordance with accepted modem medical practice, developments in
communications technology are making it ever more possible to
provide medical services in a time and place independent
manner.
[0006] Prior art methods of clinical services are generally limited
to in-hospital operations. For example, if a physician needs to
review the performance parameters of an implanted device, the
patient will likely visit the clinic. If the medical condition of
the patient with the implanted device warrants a continuous
monitoring or adjustment of the device, the patient will have to
stay in the hospital for an extended period of time. Such
continuous treatment plans pose both economic and social hardship
on patients. Depending on the frequency of data collection this
procedure may seriously inconvenience patients that live in rural
areas or have limited physical mobility. The need for upgrading the
software of an implanted medical device also requires another trip
to the hospital to have the upgrade installed. Further, as the
segment of the population with implanted medical devices increases
many more hospitals, clinics and service personnel will be needed
to provide in-hospital care to patients, thus escalating the cost
of healthcare.
[0007] Emergency trips to the hospital or clinic also increase the
cost of healthcare due to lack of early detection of heart
conditions, such as arrhythmias, that are treatable with less
invasive practices such as medicinally, if the condition is
detected on a timely basis. As the heart condition worsens, the
need for physician intervention and long term hospitalization and
medication increases. Current detectors of heart conditions, such
as arrhythmia detectors, are available but these devices suffer
from the shortcomings of external monitoring devices. The
difficulties of patients to educate and inform themselves about
medical devices prospectively or devices implanted in them, outside
of the confines of the hospital, and to participate in their own
clinical care and therapy by learning of the latest developments in
this area are additional factors that contribute to the increasing
costs of healthcare.
SUMMARY OF THE INVENTION
[0008] Various embodiments of the present invention are directed to
addressing various needs in connection with reducing healthcare
costs by facilitating the access of general and specific
information on a patient's implanted medical device (IMD), thereby
allowing the patient to participate in their own clinical care and
therapy. Accordingly, the present invention provides a method and
system for facilitating a patient's access to current IMD
diagnostic data for timely administration of medical therapies with
the assistance of an data processor.
[0009] In various embodiments the present invention supports a
communications system for providing web-based data resources to
capture, analyze, format and display patient-specific information
on demand and in real-time. In addition, the invention provides an
Internet-based secure site to enable a patient to uplink their IMD
to transfer data into a data management center where the data is
analyzed and relevant therapy/clinical care is dispensed
accordingly. Another aspect of the invention pertains to arrhythmia
management via a programmable patient arrhythmia notification
device in coordination with the patient's IMD. The notification
device can also communicate with a web-based remote data management
center. In another aspect of the invention, IMD patients have
access to a web-based data management system for IMDs for accessing
various clinical and therapy alternatives and related
information/services.
[0010] According to one embodiment of the invention, a method and
system facilitates the access by a patient of implanted medical
device related data for patient participation in clinical care and
therapy. The method includes establishing a communications link
between an implanted medical device and a data processor via an
implanted medical device interface. Access to a secured database is
obtained via the implanted device data processor using a set of
patient identification data. A query is then submitted via the data
processor to the secured database in response to input of patient
diagnostic data. Data received from the secured database is then
displayed for use in a patient evaluation.
[0011] According to another embodiment of the invention, a method
and system facilitates access by an IMD patient to their own IMD
diagnostic data for patient education and evaluation. The method
includes establishing a communications link between an implanted
medical device and a data processor via an implanted medical device
interface. Access to a secured database is obtained via the data
processor by using a set of patient identification data. Further, a
set of patient diagnostic data from the implanted medical device is
then transmitted to the data processor for processing. A set of
formatted data is then generated, as a function of a data request
from the patient, via the data processor using the patient
diagnostic data. The set of formatted data received from the
secured database via the data processor is then displayed for use
in a patient evaluation regimen as required by the doctor or
established medical care.
[0012] The above summary of the present invention is not intended
to describe each illustrated embodiment or every implementation of
the present invention. The figures in the detailed description that
follow more particularly exemplify these embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The invention may be more completely understood in
consideration of the following detailed description of various
embodiments of the invention in connection with the accompanying
drawings, in which:
[0014] FIG. 1A illustrates a block diagram of a system for
facilitating the access by an MD patient to a data processor
capable of processing IMD related data in accordance with an
example embodiment of the invention;
[0015] FIG. 1B is a flow diagram illustrating an example manner of
implementing therapies in connection with detected heart conditions
in accordance with an example embodiment of the invention;
[0016] FIG. 2 is a flow diagram illustrating another manner of
accessing IMD diagnostic data and implementing therapies in
connection with detected heart conditions in accordance with
another example embodiment of the invention; and
[0017] FIG. 3 is a diagram of a system for accessing and processing
IMD information as a function of an IMD patient's request in
accordance with an example embodiment of the invention.
[0018] While the invention is amenable to various modifications and
alternative forms, specifics thereof have been shown by way of
example in the drawings and will be described in detail. It should
be understood, however, that the intention is not to limit the
invention to the particular embodiments described. On the contrary,
the intention is to cover all modifications, equivalents, and
alternatives falling within the spirit and scope of the invention
as defined by the appended claims.
DETAILED DESCRIPTION
[0019] The present invention is generally directed to a method and
system for generating an IMD related data response as a function of
a detected condition in connection with a patient's IMD. While the
present invention is not necessarily limited to such an
application, the invention will be better appreciated using a
discussion of example embodiments in such a specific context.
[0020] Early patient notification of various heart conditions can
empower a patient to take direct action regarding management of the
identified heart condition. In the case of arrhythmias, a device
guided antiarrhythmic therapy would allow patients to use drug
therapy based upon implanted device notification rather than having
to seek medical attention for recurring arrhythmic events. One of
the capabilities provided by the present invention is that of
arrhythmic detection with programmable notification tailored to
specific drug therapies. Accurate detection of atrial fibrillation
is a component of a properly operating patient notification device
and IMD therapy implementation system.
[0021] In an example embodiment, an external messaging system is
provided and adapted to communicate with an IMD and use an
alpha-numeric messaging program to instruct the patient when to
schedule drug therapy. A configurable treatment process is
incorporated into an arrhythmia monitoring and notification system
for guiding medication therapy for arrhythmia termination, fast
ventricular response, or anticoagulation therapy. The configurable
features cooperate with the external messaging circuit to assist in
scheduling or rescheduling therapy based on patient action and drug
delivery timing. The process also provides closed loop
communications between an implantable drug delivery system and an
implanted electrical therapy device. The system of the present
invention greatly simplifies the patient's role in the decision
loop for self-administration of IMD therapies.
[0022] Referring now to the figures, FIG. 1A illustrates a block
diagram of a system 100 for facilitating the access by a patient to
an implanted medical device data processor that is capable of
detecting various conditions in accordance with an example
embodiment of the invention. System 100 facilitates the access by a
patient to implanted medical device related data for the patient's
participation in clinical care and therapy. System 100, in this
example, includes an IMD port interface 104 that is coupled to an
IMD 102 via a communications link 106. Communications link 106 is
established, in this example, via telemetry when port interface 104
is in close proximity to the MD. The link can also be established,
for example, with radio frequency signal based telemetry. MD
interface 104 includes features of a programming head or wand that
is incorporated into a programming unit for detecting and
transmitting IMD diagnostic data. In another embodiment, IMD
interface 104 includes an IRM (Interactive Remote Monitor) that is
used to uplink data from the implanted device to IMD data processor
108 or to a related website. IMD port interface 104 is coupled via
communications link 110 to an IMD data processor 108, which
includes a database 109. Communications link 110 can be established
via a telephone, a video conference call, a cellular telephone, via
a separate Internet connection or other related communications
formats for the transmission of data and voice to IMD data
processor 108. IMD data processor 108 is coupled via a
communications link 111 to a communications network 112, which
includes a server 113. Network 112 is in turn coupled to a data
processing center 114 via a communications link 116. The data
processing center includes medical personnel that analyze and
evaluate diagnostic data received from an MD. The data processing
center may be co-located with the patient or may be located remote
from the patient and accessed through communications network
112.
[0023] In this example embodiment, a patient messaging system (PMS)
118, co-located with IMD 102 is coupled to IMD data processor 108
via IMD interface 104. PMS 118 includes a display 119 and a circuit
adapted to assess and detect heart conditions in conjunction with
the IMD. The circuit includes a processor 118A and a memory
arrangement 118B as well as an audio signal arrangement (not shown)
for emitting sounds that are audible by a patient having IMD 102. A
similar circuit is also within data processor 108 for remote
detection of heart conditions. In one example embodiment, PMS 118
is coupled to IMD 102 via a telemetry link 120 and is adapted to
access IMD status information and independently alert the patient
of a heart condition that requires some form of therapy or
treatment. The patient is then advised of the therapy options
available for treating the detected condition. In another
embodiment, the patient initiates a patient query to determine IMD
status. In both embodiments, PMS 118 generates at least one
suggested therapy (medicinal and/or electrical pulse) that is
displayed on display 119 and that is be exercised or administered
primarily by the patient. In yet another embodiment, PMS 118 is
also capable of programming or reconfiguring certain program
features within IMD 102.
[0024] System 100 of the present invention provides the
capabilities of notifying a patient of an arrhythmia onset and
guiding the patient and/or physician to administer the appropriate
drug or electrical therapy. By using PMS 118, which in this example
is an alphanumeric messaging and programmable patient notification
device, the patient is guided through various pharmacological and
electrical therapies as required. The patient can now critically
time the taking of medications to terminate an arrhythmic event or
slow down the ventricular rate or use the medication in combination
with electrical therapies. The longer the arrhythmia duration, the
less successful medications will be in terminating the arrhythmia.
In addition, anticoagulation drug therapy may have to be extended
for an additional 3-4 weeks to reduce the risk of a stroke to the
patient. Notification via PMS 118, which is proximate to IMD 102
(via a wrist worn device or a personal digital assistant type
device), is useful in guiding the patient through anticoagulation
therapy when events are long lasting and unresponsive to medical
and/or electrical therapies. System 100, via PMS 118, provides the
feature of advising the patient in real time of the success or
progress of the elected treatment or therapy. Furthermore, since
some medications can increase the likelihood that antitachycardia
pacing or defibrillation therapies will terminate an arrhythmia,
PMS 118 will guide the patient as to the appropriate time to take
certain medication in order for electrical therapies to be more
successful.
[0025] Referring again to FIG. 1A, a communications link is first
established between IMD 102 and MD data processor 108 via IMD port
interface 104. In a related embodiment, the communications link is
established directly between the IMD and data processor 118A in
order to establish two way communications between the patient and
PMS 118 for the patient implemented therapies scenario. Implanted
medical device database 108, which is a secured database or website
provided via MD data processor 108, is then accessed by using a set
of patient identification data. In this example embodiment, the
patient identification data is the serial number of the IMD but can
be a special code that is assigned to the IMD patient for obtaining
access to the secured database. System 100 facilitates access by
the patient having IMD 102 of the secured database using the IMD
serial number as the password, after which the patient requests
information and/or data from the database. Information available to
the patient includes, but is not limited to, information about the
particular IMD in use, latest technological developments, clinical
trials, patient/lifestyle guidelines, support group information,
special HOT LINE numbers for emergencies, dietary and exercise
programs and additional links to other websites. System 100 detects
the condition at the IMD patient location that the patient is
seeking information or data and proceeds to provide the data as a
function of the inquiry made. The data response is then generated
by IMD data processor 108 and displayed (e.g., on a CRT or LCD
screen or LED display) for use by the patient in educating himself
on current IMD health concerns or issues.
[0026] In another example embodiment, processor 118A communications
with the patient is initiated by either the patient or by PMS 118
where a heart condition is detected. In this example, the patient
of IMD 102 actively seeks a status evaluation of (or a treatment
strategy for) his IMD with respect to his heart and either
activates PMS 118 or obtains access to IMD data processor 108 for
an evaluation or detection of at least one of a plurality of
current heart conditions. Once the link with the IMD data processor
108 (or PMS 118) is established, patient diagnostic data is
uplinked to the IMD data processor (or PMS 118) for evaluation and
detection of the patient's heart condition. Detectable heart
conditions include, but are not limited to, arrhythmia,
tachycardia, bradycardia and eventual heart failure and are
detected over IMD port interface 104 for processor 108 (or directly
by 118A from the IMD). A data response as a function of the
detected heart condition is then generated by IMD data processor
108 (or PMS 118) and is displayed for use in patient evaluation. In
an example embodiment, the data response is displayed on display
119 of PMS 118 and includes a list of recommended medicinal and/or
electrical impulse therapies that are administered by the patient
(or a medical assistant).
[0027] Referring now to FIG. 1B, a flow diagram 140 illustrates an
example manner of processing IMD diagnostic data and implementing
therapies in connection with detected heart conditions, in
accordance with an example embodiment of the invention. In general,
the system guided drug therapy process is illustrated is
programmable and is intended to interact and communicate with
external messaging systems. In a related embodiment, a patient
activator (not shown) communicates with PMS 118 to properly time
electrical therapies with medication therapies. In this example
embodiment, at step 142 atrial fibrillation (AF) is initiated or
commences and lasts for a certain duration of time, with the time
value exceeding a predefined time value before the patient
notification process starts or before the patient notices that a
problem may be occurring. At step 143 PMS 118 initiates
communication with the patient, and depending on the time duration
or other defined criteria, will follow either steps 144, 150, 154
or 158. At step 144, PMS 118 advises patient that AF has exceeded a
time value of T1 and/or that the Burden has exceeded a certain
Burden limit value (B limit) and that it is time to initiate
therapy. In this example, the patient is alerted by an alarm signal
coming from PMS 118 and is instructed at step 146, via an
alphanumeric message on display 119, as to his treatment options.
In this example, his treatment options include either drugs or
pacing options or a combination of both. Two way communications
already having been established as discussed earlier, the patient
exercises one of the treatment options and advises PMS 118 of the
treatment option exercised. At step 148, PMS 118 notifies the
patient whether AF has terminated. If AF has not terminated, the
process can loop back to step 144 or move to another step in
process 140.
[0028] At step 150, the patient is notified by PMS 118 that the
time duration has exceed a time value of T2, or a burden limit (or
any other criteria that is a function of AF duration). At step 152,
the patient is advised on patient management treatment options,
which in this example includes taking anticoagulant medication. The
patient again proceeds to exercise one of the treatment options and
advises PMS 118 of the option exercised. As in the example
described above, the process moves to step 148 where the patient
waits to be notified that AF has terminated.
[0029] At step 154, PMS 118 notifies the patient that the
ventricular rate metric has exceeded a time value of T3. At step
156, the patient is advised on patient management treatment
options, which in this example includes taking rate-controlling
medication. The patient again proceeds to exercise one of the
treatment options and advises PMS 118 of the option exercised. As
in the example described above, the process moves to step 148 where
the patient waits to be notified that AF has terminated.
[0030] At step 158, PMS 118 notifies the patient that heart failure
is beginning due to a prolonged AF condition. In one example, a
sensor input that detects heart failure communicates the condition
to PMS 118 in order that the patient is alerted of this condition.
At step 160, the patient is advised on patient management treatment
options, which in this example includes taking medication to
control on the onset of heart failure and/or to call his physician
immediately. The patient again proceeds to exercise one of the
treatment options and advises PMS 118 of the option exercised. As
in the example described above, the process moves to step 148 where
the patient waits to be notified that AF has terminated. In all of
the embodiments described, the patient has the choice of taking
control of his own therapy with the guidance and regular feedback
(via two-way communication) of PMS 118.
[0031] Referring now to FIG. 2, a flow diagram 200 illustrates
another manner of accessing and processing IMD diagnostic data, and
implementing therapies in connection with detected heart
conditions, in accordance with an example embodiment of the
invention. At step 202, IMD data processor 108 (or processor 118A
of PMS 118) detects an atrial fibrillation and the patient is
notified by an audible sound emitted by PMS 118. In another example
embodiment, the audible sound is prompted by a notification signal
117 sent by IMD data processor 108 via interface 104 to PMS 118. In
this example embodiment, the patient of IMD 102 is advised of the
detection of one of three conditions: patient alert for Atrial
fibrillation (AF; step 204); patient alert for anticoagulation
(step 230); and patient alert for rapid and prolonged ventricular
rate (step 240). Depending on the detected condition, a different
path is followed by the IMD patient in administering therapy with
the assistance of PMS 118 and system 100. In one example, the
patient is notified via PMS 118 to take a medication 206 and to
advise PMS 118 when the medication has been taken. At step 208, a
determination is made whether the AF is still present. If not, at
step 210 the patient is notified that AF is terminated. If so, at
step 212 the patient is advised accordingly and another set of
therapy options is communicated to the patient. Depending on the
programming of PMS 118, antitachycardia pacing will be
automatically delivered at an optimal drug rate, which is set by
either a fixed time interval or by a change in sensed atrial cycle
length (a surrogate of drug effect). At step 214, another
determination is made whether the AF is still present; if not, at
step 216 the patient is advised accordingly. If so, at step 218
either automatic pacing continues with a return path to 212, or the
patient, at step 220, activates the defibrillation mode of IMD 102
and applies a shock to terminate the arrhythmia.
[0032] In another embodiment, programmable PMS 118 instructs the
patient to perform electrical therapies in order to terminate the
arrhythmia. If this approach is not successful PMS 118 advises the
patient to follow another course of action by taking the medication
and activating PMS 118 to repeat the pacing therapies after a fixed
time interval or when atrial cycle length changes. Shock therapy
may be in order at this point with notification being programmed
for a fixed time interval to allow the medication ample time to
terminate the heart condition before having to provide the shock
treatment. In most of the embodiments, the patient has the option
of receiving continuous feedback via PMS 118 (or other display
methods) regarding medication efficacy.
[0033] Referring to step 230 of FIG. 2, system 100 along with PMS
118 is helpful in assisting in the management of anticoagulation
therapy. At step 232, the programmable features of PMS 118 have a
burden threshold. For example, if atrial arrhythmia is present for
greater than a certain portion of a 24-hour interval, the patient
is notified to start anticoagulation therapy and/or see a
physician.
[0034] Referring to step 240, system 100 assists in the management
of ventricular rate control for patients with paroxysmal AF. PMS
118 and system 100 provide guidance in the use of medication only
when needed, since rate controlling medications are poorly
tolerated. This treatment strategy greatly improves a patient's
quality of life by using the programmable feature of PMS 118; at
step 242, to intermittently use rate control medications. At step
244, a determination is made whether the ventricular response is in
the alert criteria zone, such as a fast zone. If so, at step 246
the patient is notified via the alert feature of PMS 118 that an AF
is occurring (ventricular response is in the fast zone) and to
start taking the rate control medication. If the ventricular
response is not in the criteria zone, at step 248 the patient is
notified that the ventricular response is normal. At step 250,
another determination is made whether AF is present. If so, at step
252 patient continues the rate control medication. If AF is not
present, at step 254 the patient is notified that AF has terminated
and rate controlling medication therapy is to be terminated. In
this example embodiment, for patients with chronic AF with
accelerated (or breakthrough) fast ventricular response, PMS 118
alerts the patient to take an extra dose of rate control
medication. If that dose is ineffective, or more than two extra
doses are needed within a 24 hour to prevent a fast ventricular
response, then the patient is notified to visit a physician.
[0035] In another embodiment, the antiarrhythmic, anticoagulation
and ventricular rate control medication therapies guided by system
100 are simultaneously implemented. A patient that has an episode
of AF is notified to take an antiarrhythmic medication in an
attempt to terminate the arrhythmia. PMS 118 also notifies the
patient that the ventricular response is in the fast zone and
should also take a rate control medication. If no such therapies
are successful and AF burden falls into the anticoagulation zone,
the patient is notified to start anticoagulation therapy.
[0036] PMS 118 provides instructions to the patient on when
medications and electrical therapies should be delivered based upon
programmable features. The programmable features complement any
device in the system that monitors, detects and notifies patient
when an arrhythmia is occurring. Treatment options generated by PMS
118 include: 1) medications only and not implementing any
electrical therapies, such as in the equipment sold under the brand
Reveal.TM.; 2) implementing pacing backup for drug-induced
bardycardia; 3) implementing pacing backup with antitachycardia
(AT500.TM.); or 4) implementing pacing backup, antitachycardia
pacing and defibrillation (Jewel AFTM). PMS 118, in one embodiment,
is a handheld device using standard telemetry communications
protocols or a wristwatch device using radio frequency signals to
establish the telemetry link with the IMD. The patient uses the
handheld device upon receiving an audible notification tone (from
PMS 118) to place the handheld device in close proximity to the IMD
or an IPG (implanted pulse generator). The alphanumeric messaging
circuit then instructs the patient regarding rhythm status and the
type of medication or electrical therapies need to be administered.
The patient also uses the handheld device to instruct the IPG as to
when a medication was taken in order that electrical therapies are
timed to occur at a maximal medication effect. Thus, any synergies
between medication and electrical therapies are exploited.
[0037] Some of the advantages provided by the various embodiments
of the present invention include: early recognition of the need for
therapy; proper diagnosis and therapy early in the detection
process; and reduced risk of toxicity from medications that would
normally be taken chronically due to an inability to properly
diagnose the heart condition. With the present invention,
antiarrhythmic medications are administered when an atrial
fibrillation occurs and the patient is not be burdened with the
expense, toxicity and inconvenience of daily medication
consumption. In addition, quantifying the daily AF burden and
ventricular response can guide usage of anticoagulation and rate
control drug. Moreover such diagnosis and patient awareness will
document drug therapy efficacy on a real time basis. By diagnosing
on a timely basis a patient's heart condition, such as an
arrhythmia, undesirable consequences such as chronic AF, congestive
heart failure or thromboembolic events can be avoided. Continuous
monitoring of heart rhythm with patient notification of arrhythmia
onset and termination will allow the patient to be in control of
their AF management. With improved arrhythmia management provided
by the present invention the patient is alerted to take medication,
to deliver electrical therapy (pacing or defibrillation) or seek
medical attention before onset of conditions requiring
anticoagulation therapy.
[0038] FIG. 3 illustrates a system 300 for accessing and processing
IMD patient diagnostic data, as well as formatting such data as a
function of the IMD patient's request, in accordance with an
example embodiment of the invention. The method and system
facilitate the access by an IMD patient of diagnostic data for
patient education and evaluation. IMD information is retrievable
from and is displayable at a home environment 302, for example.
Additional information is retrievable through a database located at
a data processing center or hospital via the Internet 304. Patient
information that is retrieved in a healthcare facility 306, and
stored in a secured database, is accessible by the patient via the
Internet 304 or by telephone or other communication systems.
[0039] In this example embodiment, the patient first establishes a
communications link between the IMD and the IMD data processor 108
via the IMD device interface as in FIG. 1. A secured IMD database
provided by the MD data processor is then accessed using a set of
patient identification data (e.g., IMD serial number or an
alpha-numeric password assigned by database manager). A set of
patient diagnostic data from IMD 102 is then transmitted via an
uplink transmission to IMD data processor 108 for processing. A set
of formatted data is generated, as a function of a request from the
patient, by IMD data processor 108 using the patient's diagnostic
data. In one example, current diagnostic data is compared with the
patient's historical information stored in database 109. In another
example, the data is also formatted to draw comparisons with
information from other IMD users to illustrate a trend or for
recognition of a pattern in the patient's IMD operation. The
formatted data generated by IMD data processor 108 is then
displayed for use in the patient's own evaluation or as an
interactive tool to be used with the physician or with a data
processing center having staff knowledgeable in implanted medical
devices. In another embodiment, the interactive component is
available for discussing the patient formatted data with a remotely
located expert data center or physician. This can include a voice
connection via a home PC or using the telephone to have a
discussion concerning the displayed data.
[0040] As illustrated in FIG. 3, the patient diagnostic data is
retrievable from the IMD and certain heart conditions are
detectable by IMD data processor 108 (or PMS 118) that include, but
are not limited to, Atrial Fibrillation, Ischemia, Mich.
(Myocardial Infarction) and SCD (Sudden Cardiac Death) detection
and prediction. Other equipment that can be incorporated into
system 100 for improved diagnostic capability of a patient's IMD
condition include: implanted event recorders, implanted diagnostic
monitors and pacing/defibrillation systems. Other non-invasive
physiological information can also be gathered by system 100 that
would assist the patient in conducting a minimal level of
self-health evaluation. For example, ECG information is retrievable
for analysis by the patient well before a health condition occurs
that requires hospitalization. This information is recorded in the
database 109 for later use in patient diagnostic data analysis and
is accessible through server 113 of communications network 112 or
through the Internet 304.
[0041] Some of the advantages provided by the various embodiments
of the present invention include enhanced patient availability for
regular IMD and ECG evaluations and a comfortable interrogation
session in a patient's home or familiar environment that eliminates
the necessity of traveling to the hospital.
[0042] The present invention is compatible with a number of
techniques for interrogating implanted medical devices, such as
drug pumps, neurological implants, nerve stimulators, various
cardiac implants and equivalent medical devices. In addition, the
embodiments described are compatible with remote patient management
systems that interact with remote data and expert data centers and
compatible with a data communication system that enables the
transfer of clinical data from the patient to a remote location for
evaluation, analysis, data reposition, and clinical evaluation.
[0043] Various modifications, equivalent processes, as well as
numerous structures to which the present invention may be
applicable will be readily apparent to those of skill in the art to
which the present invention is directed upon review of the present
specification. The claims are intended to cover such modifications
and devices.
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