U.S. patent application number 14/132258 was filed with the patent office on 2014-04-17 for portable programmer for providing patient status information.
This patent application is currently assigned to MEDTRONIC, INC.. The applicant listed for this patent is MEDTRONIC, INC.. Invention is credited to Pierre A. Grandjean, Barbro M. Kjellstrom, Ilaria Vicini.
Application Number | 20140107502 14/132258 |
Document ID | / |
Family ID | 37876986 |
Filed Date | 2014-04-17 |
United States Patent
Application |
20140107502 |
Kind Code |
A1 |
Grandjean; Pierre A. ; et
al. |
April 17, 2014 |
PORTABLE PROGRAMMER FOR PROVIDING PATIENT STATUS INFORMATION
Abstract
A method and apparatus concerning the retrieval and storage of
status information obtained from patients having implantable
medical devices (IMDs). When patients are having episodes during
which symptoms are experienced relating to their medical condition,
the collection of the patient's status information can be helpful
to the patient's physician for diagnostic purposes. Telemetered
signals recorded by the IMD can be transmitted from the IMD to a
programmer. Such programmer is portable and sized so as to be
carried by the patient. As such, mechanisms added to such
programmers for use in retrieving and storing patient status
information can provide more convenience for patients.
Inventors: |
Grandjean; Pierre A.;
(Warsage, BE) ; Vicini; Ilaria; (Vimercate,
IT) ; Kjellstrom; Barbro M.; (Halmstad, SE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
MEDTRONIC, INC. |
Minneapolis |
MN |
US |
|
|
Assignee: |
MEDTRONIC, INC.
Minneapolis
MN
|
Family ID: |
37876986 |
Appl. No.: |
14/132258 |
Filed: |
December 18, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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11291033 |
Nov 30, 2005 |
8634925 |
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14132258 |
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Current U.S.
Class: |
600/484 ;
600/300; 600/481; 600/529 |
Current CPC
Class: |
A61B 5/0022 20130101;
A61B 5/72 20130101; A61N 1/37235 20130101 |
Class at
Publication: |
600/484 ;
600/529; 600/481; 600/300 |
International
Class: |
A61B 5/00 20060101
A61B005/00 |
Claims
1. A programmer for capturing status information from a patient
with an implantable medical device during episodes in which the
patient experiences symptoms comprising: a housing adapted to be
carried by a patient; first circuitry within the housing for
communicating with an implantable medical device implanted within
the patient, wherein signals stored by the implantable medical
device can be telemetered to the first circuitry upon interrogation
by the first circuitry; second circuitry for receiving status
information from the patient regarding a condition being
experienced by the patient; and memory for storing the signals and
the status information.
2. The programmer of claim 1, wherein the second circuitry
comprises a keypad with a plurality of keys, wherein each key is
denoted with a different symptom that the patient may
experience.
3. The programmer of claim 1, wherein the second circuitry
comprises a keypad with a plurality of keys wherein one of more of
the keys has no symptom inscription.
4. The programmer of claim 2, wherein the symptoms comprise one or
more of shortness of breath, palpitations, dizziness, and extreme
tiredness.
5. The programmer of claim 2, wherein at one of keys is denoted
with a symptom that is inscribed by a physician.
6. The programmer of claim 1 wherein the programmer is a portable
programmer, portable interrogator, portable recorder, portable
monitor, portable sensor, or portable telemetered signals
transceiver.
7. The programmer of claim 1 further comprising transmission a data
transmission link.
8. The programmer of claim 7 wherein the data transmission link is
a cellular phone link, a LANS link, an RF link, an internet link,
or a cable modem link.
Description
FIELD
[0001] The disclosure relates generally to data collection and
analysis, and more particularly, to a system and method for
providing patient status information during symptomatic
episodes.
BACKGROUND
[0002] Implantable medical devices (IMDs) are used to treat
patients suffering from a variety of conditions. Examples of IMDs
involving cardiac devices are implantable pacemakers and
implantable cardioverter-defibrillators (ICDs). Such electronic
medical devices generally monitor the electrical activity of the
heart and provide electrical stimulation to one or more of the
heart chambers, when necessary. For example, pacemakers are
designed to sense arrhythmias, i.e., disturbances in heart rhythm,
and in turn, provide appropriate electrical stimulation pulses, at
a controlled rate, to selected chambers of the heart in order to
correct the arrhythmias and restore the proper heart rhythm. The
types of arrhythmias that may be detected and corrected by such
IMDs include bradycardias (unusually slow heart rates), which can
result in symptoms such as fatigue, dizziness, and fainting, and
certain tachycardias (unusually fast heart rates), which can result
in sudden cardiac death (SCD).
[0003] Implantable cardioverter-defibrillators (ICDs) also detect
arrhythmias and provide appropriate electrical stimulation pulses
to selected chambers of the heart to correct the abnormal heart
rate. In contrast to pacemakers, however, an ICD can also provide
pulses that are much stronger and less frequent. This is because
ICDs are generally designed to correct fibrillation, which is a
rapid, unsynchronized quivering of one or more heart chambers, and
severe tachycardias, during which the heartbeats are very fast but
coordinated. To correct such arrhythmias, ICDs deliver low,
moderate, or high-energy shocks to the heart.
[0004] Generally, IMDs are designed to provide a telemetry
function. As such, the IMDs are configured to automatically
transmit and measure data from remote sources by wire or other
means. Typically, IMDs are equipped with an on-board, volatile
memory in which telemetered signals can be stored for later
retrieval and analysis. In addition, a growing class of cardiac
medical devices, including implantable heart failure monitors,
implantable event monitors, cardiovascular monitors, and therapy
devices, can be used to provide similar stored device information.
Typically, the telemetered signals can provide patient physiologic
and cardiac information. This information is generally recorded on
a per heartbeat, binned average basis, or derived basis, and
involve, for example, atrial electrical activity, ventricular
electrical activity, minute ventilation, patient activity score,
cardiac output score, mixed venous oxygen score, cardiovascular
pressure measures, time of day, and any interventions and the
relative success of such interventions. Telemetered signals can
also be stored in a broader class of monitors and therapeutic
devices for other areas of medicine, including metabolism,
endocrinology, hematology, neurology, muscular disorders,
gastroenterology, urology, ophthalmology, otolaryngology,
orthopedics, and similar medical subspecialties.
[0005] Generally, upon detecting arrhythmias and, when necessary,
providing corresponding therapies to correct such arrhythmias, the
IMDs store the telemetered signals over a set period of time
(usually before, during, and after the occurrence of such
arrhythmic event). Subsequently, current practice in the art
involves the use of an external programming unit, i.e., a
programmer, for non-invasive communication with IMDs via uplink and
downlink communication channels associated with the programmer. In
accordance with conventional medical device programming systems, a
programming head can be used for facilitating two-way communication
between IMDs and the programmer. In many known implanted IMD
systems, the programming head is positioned on the patient's body
over the IMD side such that one or more antennae within the head
can send RF signals to, and receive RF signals from, an antenna
disposed within the hermetic enclosure of the IMD or disposed
within the connector block of the IMD in accordance with common
practice in the art.
[0006] Upon storing the telemetered signals within the programmers,
such data can be subsequently analyzed by the patient's physician
for diagnostic purposes. Previously, the data stored within the
programmers was downloaded during visits to the physician; however,
recent technology has enabled the patient to download such data at
home using, for example, a personal computer (PC) and a network to
transmit the data to the physician.
[0007] For patients who require the use of IMDs, it is quite
commonplace for the patient to have episodes during which symptoms
are experienced, e.g. shortness of breath, palpitations, dizziness,
extreme tiredness, etc. However, in some cases, these episodes
occur when the IMDs are not sensing an arrhythmia, and as such, no
telemetered signals are stored with respect to such episodes.
However, the physiologic and cardiac data that can be collected
during these episodes can be of extreme importance to the
physician, as conclusions can be made (upon analyzing such data) as
to the patient's general quality of life and the suitability of the
IMD with respect to the patient. As such, during and/or following
such episodes, the patient may be instructed to keep a written
account (e.g., a written diary) of symptoms experienced. As such,
this written account can be analyzed by the physician when
analyzing telemetered signals that may have been stored by the IMD
to date. However, this task of providing a written account of the
symptoms experienced has generally been found by the patient to be
cumbersome and often not done. In turn, this lack of information
complicates analysis by the physician of the stored data and/or
clinical treatment of the patient.
[0008] The embodiments of the invention are directed to overcoming,
or at least reducing the effects of, one or more of the limitations
set forth above.
SUMMARY
[0009] Embodiments of the invention relate to the retrieval and
storage of status information obtained from patients having
implantable medical devices (IMDs). When patients are having
episodes during which symptoms are experienced relating to their
medical condition, the collection of the patient's status
information can be helpful to the patient's physician for
diagnostic purposes. Generally, telemetered signals recorded by the
IMD can be transmitted from the IMD to a programmer. Such
programmer is portable and sized so as to be carried by the
patient. As such, mechanisms added to such programmers for use in
retrieving and storing patient status information can provide more
convenience for patients.
[0010] In some embodiments, a system for monitoring a patient's
well being is provided. The system comprises a medical device
implanted in a patient, where the medical device has circuitry for
storing signals collected from the patient. The system also
comprises a patient portable programmer having first circuitry for
communicating with the medical device wherein the signals stored by
the medical device can be telemetered to the programmer upon
interrogation by the programmer. The programmer has second
circuitry for receiving and storing status information from the
patient regarding a condition being experienced by the patient.
[0011] In other embodiments, a programmer for capturing patient
status information from a patient with an implantable medical
device during episodes in which the patient experiences symptoms is
provided. The programmer comprises a housing adapted to be carried
by a patient. The programmer comprises first circuitry within the
housing for communicating with an implantable medical device
implanted within the patient, wherein signals stored by the
implantable medical device can be telemetered to the first
circuitry upon interrogation by the first circuitry. The programmer
comprises second circuitry for receiving status information from
the patient regarding a condition being experienced by the patient.
The programmer comprises memory for storing the signals and the
status information.
[0012] In further embodiments, a method of capturing status
information from a patient with an implantable medical device
during episodes in which the patient experiences symptoms is
provided. The method comprises placing a programmer within a
transmitting distance of a medical device implanted in a patient to
trigger the medical device when the patient experiences a symptom.
A further step includes transmitting signals collected by the
medical device to the programmer. An additional step involves
providing status information by the patient to the programmer. A
further step involves storing the signals and the status
information by the programmer in a memory of the programmer.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is a simplified schematic diagram representation of a
system in accordance with certain embodiments of the invention.
[0014] FIG. 2 is a plan view of a programmer in accordance with
certain embodiments of the invention;
[0015] FIG. 3 is a plan view of another programmer in accordance
with certain embodiments of the invention.
[0016] FIG. 4 is a flowchart showing the steps taken by a patient
during a patient activated event in accordance with certain
embodiments of the invention.
DETAILED DESCRIPTION
[0017] The following discussion is presented to enable a person
skilled in the art to make and use the present teachings. Various
modifications to the illustrated embodiments will be readily
apparent to those skilled in the art, and the generic principles
herein may be applied to other embodiments and applications without
departing from the present teachings. Thus, the present teachings
are not intended to be limited to embodiments shown, but are to be
accorded the widest scope consistent with the principles and
features disclosed herein. The following detailed description is to
be read with reference to the figures, in which like elements in
different figures have like reference numerals. The figures, which
are not necessarily to scale, depict selected embodiments and are
not intended to limit the scope of the present teachings. Skilled
artisans will recognize the examples provided herein have many
useful alternatives and fall within the scope of the present
teachings.
[0018] FIG. 1 is a simplified schematic diagram representation of a
system in accordance with certain embodiments of the invention. As
shown, one or more IMDs such as IMD 10, 10' and 10'' can be
implanted in a patient 12. In certain embodiments, one or more of
the IMDs 10, 10' and 10'' can have internal communications, B, B'
and B''. In certain embodiments, the IMDs include a cardiac device
10, drug delivery device 10', neurological drug device 10'';
however, it is to be appreciated that fewer or additional IMDs may
be used as needed to provide the necessary therapy, diagnosis and
clinical care to the patient 12.
[0019] As discussed herein, telemetry communications can occur
between the IMDs 10, 10', 10'' and a programmer 14 and/or an
information remote monitor (IRM) 16 when the programmer 14 and/or
the IRM 16 is generally located within transmitting proximity of
the IMDs 10, 10', and 10''. As shown, the transmitting capability
of the IMDs 10', 10', and 10'' can be wide-ranging. In certain
embodiments, as described herein, the programmer 14 and/or the IRM
16 tend to be positioned on the body of the patient 12 over the
corresponding IMD to generally initiate such telemetry
communications between the IMD and the programmer 14 and/or the IRM
16. Regarding telemetry communications 15 with the programmer 14
and/or telemetry communications 17 with the information remote
monitor (IRM) 16, the IMD 10 is discussed herein; however, as
illustrated in FIG. 1, it is to be appreciated that one or more of
the other IMDs 10', 10'' may also be used alternatively or in
combination with the IMD 10 to respectively provide telemetry
communications 15' and 15'' with the programmer 14 and/or telemetry
communications 17' and 17'' with the IRM 16.
[0020] Embodiments of the invention generally involve periods of
time when telemetered signals are collected by the IMD, periods of
time when the telemetered signals are transmitted from the IMD 10,
and subsequently, periods of time when the obtained signals are
analyzed by a physician, physician's assistants, or other care
providers. Typically, events triggering the IMD 10 can cause the
telemetered signals to be collected and stored by the IMD 10. In
certain embodiments involving cardiac applications, such collection
is beat to beat for approximately eighteen minutes before and six
minutes after the event. However, as described herein, the
invention should not be limited to only cardiac applications. In
certain embodiments involving cardiac applications, there can be
three types of triggering events: (i) a bradycardia event, (ii) a
tachycardia event, and (iii) a patient activated event. Generally,
the bradycardia and tachycardia events automatically trigger the
IMD 10, while the patient activated event requires a manual
triggering of the IMD 10 by the patient 12. In certain embodiments,
such manual triggering of the IMD 10 by the patient 12 involves a
signal being sent to the IMD 10 through some action of the patient
12.
[0021] In certain embodiments, application of the programmer 14
within transmitting proximity of an antenna of the IMD 10 can
facilitate such triggering. In certain embodiments, this triggering
can further initiate a subsequent download of at least a portion of
the telemetered signals from the IMD 10 to the programmer 14. In
such embodiments, as should be appreciated, the IMD 10 would only
subsequently download the signals if the programmer 14 is within
transmitting proximity of the IMD 10. If not, the IMD 10 can be
designed to download the data during a subsequent occasion when the
programmer 14 is brought within transmitting proximity of the IMD
10, e.g., so as to trigger the IMD 10 again.
[0022] In using the programmer 14 for manual triggering of the IMD
10, in certain embodiments, a magnetized reed switch (not shown)
within the IMD 10 closes in response to the placement of the
programmer 14 over the location of the IMD 10. Generally, the
programmer 14 includes a magnet (not visually shown), which
facilitates the closure of the reed switch. Following the closure
of the reed switch, the IMD 10 can communicate with the programmer
14 via RF signals. As such, if the programmer 14 is kept within
transmitting proximity of the IMD 10, the stored telemetered
signals can be downloaded from the IMD 10 into the programmer
14.
[0023] In certain embodiments, the IMD 10 is a Chronicle.RTM.
implantable heart monitor, commercially available from Medtronic,
Inc., located in Minneapolis, Minn. However, it is to be
appreciated that the invention should not be limited to such a
device. Generally, any form of implantable medical device suitable
for storing telemetered signals or physiological data could be
used, as known in the art. The Chronicle.RTM. is a hemodynamic
monitor and can include circuitry for data storage, recovering and
processing of pressure, electrogram, heart rate, core temperature,
and activity data. The Chronicle.RTM. is generally used in patients
with chronic Congestive Heart Failure (CHF), undergoing serial
clinical management, and is typically used to complement existing
CHF therapies and disease management regimens in order to provide
precise therapy management, early intervention by remote monitoring
of impending decompensation and to improve quality of life. The
Chronicle.RTM. generally contains an operating system that may
employ a microcomputer or a digital state machine for timing,
sensing, data storage, recovery and processing of pressure,
electrogram, heart rate and other related data, to thereby monitor
the hemodynamic environment.
[0024] In certain embodiments, the programmer 14 is an external
pressure reference monitor (EPR). However, it is to be appreciated
that the invention should not be limited to such. Generally, any
form of portable programmer, interrogator, recorder, monitor,
sensor, or telemetered signals transceiver suitable for
communicating with the IMD 10 could be used, as is known in the
art. In certain embodiments, the programmer 14 is generally carried
by a patient physically or through the use of a carrying implement
19, e.g., a clip, a belt, a wrist band, etc., so that the
programmer 14 can be kept in close proximity to the patient 12, and
in turn, the IMD 10. In certain embodiments, the carrying implement
19 can include a mechanism (e.g., a watch) that the programmer 14
is integrated with. An EPR is typically used to derive reference
pressure data for use in combination with absolute pressure derived
from an IMD. In addition, an EPR measures and records barometric
pressure which is necessary for correlation to atmospheric
pressure. Various embodiments of an EPR device are disclosed in
U.S. Pat. No. 6,152,885 issued to Taepke, which patent is
incorporated herein by reference in relevant part. Similarly, U.S.
Pat. No. 5,810,735 to Halperin et al, which patent is incorporated
herein by reference in relevant part, discloses external patient
reference sensors of internal sensors.
[0025] As described above, in certain embodiments, communication 15
between the IMD 10 and the programmer 14 is generally initiated via
direct antenna placement. In certain embodiments, the IMD 10 can
employ an elongated antenna which projects outward from the housing
of the IMD 10 as described in U.S. patent application Ser. No.
09/303,178 for "A Telemetry System for Implantable Medical
Devices", filed Apr. 30, 1999 by Villaseca et al, which application
is incorporated herein by reference in relevant part, or can employ
a coil antenna located external the housing. Once downloaded, in
certain embodiments, the telemetered signals and any other data
stored within the programmer 14, can be sent, for example, from the
patient's home, via an inter-network 18, such as the Internet, to a
remote server 20 or remote clinical/physician center 22. In certain
embodiments, the telemetered signals and other data are transmitted
from the programmer 14 via transmission links, including but not
limited to cellular phone links, LANS, RF links, regular phone
lines, cable modems and the like.
[0026] As illustrated in FIG. 1, the programmer 14 can include
software which is adaptable to enable communication with various
types of IMDs, including but not limited to cardiac devices, neural
implants, drug delivery systems and other medical devices. In
certain embodiments, the programmer 14 is adapted for connection to
a PC 24 for data transfer. In the alternate, the PC 24 may be used
to control the programmer 14 to program the implanted device,
thereby implementing the programmer 14 as a programming device. In
certain embodiments, the programmer 14 can transfer the telemetered
signals and data through the PC 24 to the server 20 or the remote
clinical/physician center 22 via a modem and other wireless
communications media. In certain embodiments, the programmer 14 can
utilize an integral modem to dial a server and transfer data via
FTP, PPP and TC/PIP protocols.
[0027] In certain embodiments, the programmer 14 is designed to
include a microphone 26 and voice recording circuitry (shown in
FIG. 2), where such circuitry is internal to the programmer 14. A
transducer 28 (FIG. 2) can be provided, for example, under
perforations 30 in the body of the microphone 26 in order to
receive voice data from the patient 12. As shown in FIG. 2, when
activated by the patient 12 (e.g., by depressing a "record" button
32 located on the programmer 14), the transducer 28 generally
converts audio signals to analog electrical signals. In turn, an
analog to digital (A/D) converter 34 preferably converts the analog
electrical signals into digital data. Further, the digital data
from the A/D converter 34 can be preprocessed by a digital signal
processor (DSP) 36 before being passed to a processing and memory
circuit 38 of the programmer 14. In other embodiments (not shown),
the DSP 36 can be omitted and the digital data from the A/D
converter 34 could be passed directly to the processing and memory
circuit 38. Following such recording, the patient 12 can terminate
the recording by, in certain embodiments, depressing a "stop"
button 40 located on the programmer 14. In certain embodiments, the
"record" and "stop" buttons 32, 40 respectively are recessed into
the body of the programmer 14 to avoid accidental depression of the
buttons when handling the programmer 14.
[0028] As mentioned above, the microphone 26 can be used to receive
voice data from the patient. Similar techniques of recording voice
data are suggested in U.S. Pat. No. 5,749,908 issued to Snell,
which patent is incorporated herein by reference in relevant part.
In certain embodiments, the patient 12 can use the microphone 26
and associated recording circuitry in the programmer 14 to store
what is being felt during episodes in which the patient 12
experiences symptoms, e.g. shortness of breath, palpitations,
dizziness, extreme tiredness, etc. Techniques of a patient
recording symptoms are suggested in U.S. Pat. No. 6,331,160 issued
to Bardy, which patent is incorporated herein by reference in
relevant part.
[0029] As mentioned above, when the patient 12 has episodes in
which the above-stated or other symptoms are experienced, quite
often, the IMD 10 is not triggered. As such, in certain
embodiments, the patient 12 is requested to trigger the IMD 10 upon
experiencing these symptoms to store and transfer the telemetered
signals associated therewith. By further designing the programmer
14 to include the microphone 26 and associated recording circuitry,
the system enables the patient to describe their symptoms. As such,
the system is convenient to the patient 12 as well as beneficial to
the patient's physician. For example, such programmer design allows
the patient 12 to record voice data at the same time or shortly
after the time he is triggering the IMD 10 during a patient
activated event, as the programmer 14 would generally be held over
the position of the IMD 10 for triggering purposes and, as such,
close to the patient's mouth for recording purposes. Additionally,
such programmer design enables the technique of recording to be
"ready made" for the patient 12, since the programmer 14, as
described earlier, is designed to be portable and carried by the
patient 12. Further, the programmer design allows the simultaneous
storage of telemetered signals from the IMD 10 with digital data
corresponding to voice recordings from the patient 12, so as to
group such information together for subsequent analysis by the
patient's physician. In certain embodiments, the signals and
recordings are grouped through the use of a clock circuit (not
shown) internally located within each of the IMD 10 and the
programmer 14 to correspondingly mark the telemetered signals and
digital data stored in the memory of the programmer 14.
[0030] As shown in FIG. 3, in certain embodiments, the programmer
14 is designed to include a key pad 42 with a plurality of labeled
keys 44 recessed into the body of the programmer 14. The keys 44
are recessed so as to avoid accidental depression of the keys 44
when handling the programmer 14. Similar to the function of the
microphone 26 and recording circuitry discussed above, in certain
embodiments, the patient 12 can use the labeled keys 44 on the
programmer 14 and associated memory within the programmer 14 to
store what is being felt during episodes in which the patient 12
experiences symptoms, e.g. shortness of breath, palpitations,
dizziness, extreme tiredness, etc. In certain embodiments, each
symptom that may potentially be experienced by the patient 12 is
generally inscribed on a distinct label, with the labels being
attached to separate keys 44. In certain embodiments, there may be
one or more keys 44 that have no such inscription on their
corresponding labels. As such, the physician can inscribe the one
or more keys 44 with respect to symptoms that are frequently
experienced by the patient, yet may not already be included on the
keys 44 that were previously inscribed. In turn, the design of the
programmer 14 can be altered so as to function accordingly with
future depression by the patient 12 of such keys 44 inscribed via
the physician.
[0031] In certain embodiments, when any one of the inscribed keys
44 is depressed by the patient 12, an electrical signal is sent
from the depressed key 44 to a processing and memory circuit 46
within the programmer 14, where such processing and memory circuit
46 includes or is linked to a database 48. The database 48 is used
to store a plurality of digital values, each value being associated
with one of the symptoms labeled on the keys 44. In certain
embodiments, upon receiving the electrical signal from the
depressed key 44, the processing and memory circuit 46 is
programmed to locate the corresponding digital value within the
database 48, and store such value.
[0032] By further designing the programmer 14 to include the
labeled keys 44 thereon and the processing and memory circuit 46
therein, the system enables the patient to indicate their symptoms.
Thus, the system is convenient to the patient as well as beneficial
to the patient's physician. For example, such programmer design
allows the patient 12 to depress the key(s) 44 at the same time or
shortly after the time the IMD 10 is triggered during a patient
activated event. Locating and depressing the keys 44 on the
programmer 14 which correspond to the symptoms being experienced
would take a few seconds as the programmer 14 is generally held
over the position of the IMD 10 for triggering purposes.
Additionally, such programmer design enables the technique of
depressing keys to be "ready made" for the patient 12, since the
programmer 14, as described earlier, is designed to be portable and
carried by the patient 12. Further, the programmer design allows
the simultaneous storage of telemetered signals from the IMD 10
with digital values corresponding to the keys depressed by the
patient 12, so as to group such information together for subsequent
analysis by the patient's physician. In certain embodiments, the
signals and digital values are grouped through the use of a clock
circuit (not shown) internally located within the programmer 14 to
correspondingly mark the telemetered signals and recordings stored
in the memory of the programmer 14.
[0033] It is to be appreciated that, in certain embodiments, the
programmer 14 may incorporate both the microphone 26 and voice
recording circuitry as shown in FIG. 2 and the key pad 42 with a
plurality of pre-labeled keys 44 as shown in FIG. 3. In using the
programmer 14 with additional functions as described with respect
to FIGS. 2 and/or 3, the patient can more readily and conveniently
record what is being experienced during such symptomatic episodes.
As such, by using one or more of these functions of the programmer
14, the patient would no longer need to keep a written account
(e.g., a written diary) of symptoms experienced over time. In turn,
this stored patient status information can be used by the physician
when analyzing telemetered signals stored by the IMD to date to aid
in treating the patient 12.
[0034] As shown in FIG. 1, in certain embodiments, the programmer
14 can be adapted to communicate with an information remote monitor
(IRM) 16 as mentioned with respect to FIG. 1. In use, the IRM 16
can be positioned a certain transmitting distance from the
programmer 14 to enable the transmission of the telemetered signals
and patient status information (e.g., digital data corresponding to
voice recordings or keys depressed by the patient 12 on the
programmer 14) from the programmer 14. Additionally, the IRM 16 can
also be so positioned from the IMD 10 to enable telemetry
communication 17 of any other telemetered signals held by the IMD
10 which may not be stored by the programmer 14. In certain
embodiments, wireless communication between the IRM 16 and the
programmer 14 and/or the IMD 10 may be implemented using, for
example, various types of RF signals blue tooth or equivalent, for
downloading the signals from the IMD 10 and/or the programmer 16 to
the IRM 14. Following transfer of the data from the programmer 14
and/or IMD 10, the IRM 16 can be used from a patient's home to
subsequently transmit the data to the remote server 20 and/or the
remote clinical/physician center 22 to enable remote and chronic
patient monitoring and management.
[0035] In certain embodiments, the data is sent, for example, from
the patient's home via the inter-network 18, such as the Internet,
to the remote server 20 or remote clinical/physician center 22. In
certain embodiments, the data is transmitted from the IRM 16 via
transmission links, including but not limited to cellular phone
links, LANS, RF links, regular phone lines, cable modems and the
like.
[0036] As illustrated in FIG. 1, the IRM 16 can include software so
as to enable communication with various types of IMDs, including
but not limited to cardiac devices, neural implants, drug delivery
systems and other medical devices. In certain embodiments, the IRM
16 is adapted for connection to the PC 24 for data transfer. In the
alternate, the PC 24 may be used to control the IRM 16 to program
the implanted device, thereby implementing the IRM 16 as a
programming device. In certain embodiments, the IRM 16 can transfer
the data through the PC 24 to the server 20 or the remote
clinical/physician center 22 via a modem and other wireless
communications media. In certain embodiments, the IRM 16 can
utilize an integral modem to dial a server and transfer data via
FTP, PPP and TC/PIP protocols.
[0037] FIG. 4 is a flowchart showing the steps taken by a patient
during a patient activated event in accordance with certain
embodiments of the invention. An initial step 50 involves the
patient 12 with IMD 10 (FIG. 1) having an episode in which he/she
experiences symptoms, e.g. shortness of breath, palpitations,
dizziness, extreme tiredness, etc. Upon feeling such symptoms, the
patient 12 places the programmer 14 above the position of the IMD
10 in the patient 12 to trigger the IMD 10 in step 52. As mentioned
herein, such symptoms experienced by the patient 12 may often not
result in a triggering of the device; however, there are cases in
which the IMD 10 is triggered by such symptoms. Such question
regarding the state of triggering of the IMD 10 is shown in step
54. If the IMD 10 is triggered by placing the programmer 14 at the
position of the IMD 10, step 56 involves the IMD 10 storing the
telemetered signals associated with such event for a preprogrammed
period of time. If the IMD 10 had already been triggered by the
symptoms, step 56 is skipped, as shown. Step 58 involves the
patient 12 providing status information as to the symptoms being
experienced. In certain embodiments, steps 56 and 58 can take place
at the same time.
[0038] With further reference to FIG. 4, step 60 involves
transmitting the collected telemetered signals from the IMD 10 to
the programmer 14. As described above, step 60 and subsequent steps
can occur during a subsequent triggering of the IMD 10 if the
programmer 14 is not kept within transmitting proximity of the IMD
10 during the prior triggering. Step 62 involves transmitting the
telemetered signals and patient status information to the remote
server 18 and/or the remote clinical/physician center 20 for remote
and chronic patient monitoring and management. If IRM 16 is
provided in the system, a further step can be involved between
steps 60 and 62 involving transmitting the telemetered signals from
the IMD and/or the programmer 14.
[0039] It will be appreciated the embodiments of the present
invention can take many forms. The true essence and spirit of these
embodiments of the invention are defined in the appended claims,
and it is not intended the embodiment of the invention presented
herein should limit the scope thereof.
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