U.S. patent application number 15/000616 was filed with the patent office on 2016-05-12 for means and method for the detection of cardiac events.
The applicant listed for this patent is ANGEL MEDICAL SYSTEMS, INC.. Invention is credited to DAVID R. FISCHELL, ROBERT E. FISCHELL, TIM A. FISCHELL, JONATHAN HARWOOD, STEVEN R. JOHNSON.
Application Number | 20160128595 15/000616 |
Document ID | / |
Family ID | 38620373 |
Filed Date | 2016-05-12 |
United States Patent
Application |
20160128595 |
Kind Code |
A1 |
FISCHELL; DAVID R. ; et
al. |
May 12, 2016 |
MEANS AND METHOD FOR THE DETECTION OF CARDIAC EVENTS
Abstract
A system for detecting cardiac events and alerting the patient
of the cardiac event issued by an implanted medical device. A
processor detects a cardiac event and issues an activation signal
to a patient alerting mechanism which emits an alarm during a first
time interval followed by an alarm-off period of time. Reminder
alarms are issued periodically following the alarm-off period of
time. Reminder alarms are issued during reminder on-periods of time
which are shorter than the first time interval. The alarm-off
period and the time between periodic reminder alarms are greater
than the alarm first time interval. A disabling device permits
disabling of reminder alarms.
Inventors: |
FISCHELL; DAVID R.; (FAIR
HAVEN, NJ) ; FISCHELL; TIM A.; (KALAMAZOO, MI)
; HARWOOD; JONATHAN; (RUMSON, NJ) ; FISCHELL;
ROBERT E.; (DAYTON, MD) ; JOHNSON; STEVEN R.;
(FAIR HAVEN, NJ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ANGEL MEDICAL SYSTEMS, INC. |
FAIR HAVEN |
NJ |
US |
|
|
Family ID: |
38620373 |
Appl. No.: |
15/000616 |
Filed: |
January 19, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14499942 |
Sep 29, 2014 |
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15000616 |
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11812836 |
Jun 22, 2007 |
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14499942 |
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10853058 |
May 26, 2004 |
7558623 |
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11812836 |
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Current U.S.
Class: |
600/518 ;
600/509; 600/515 |
Current CPC
Class: |
A61B 5/0452 20130101;
A61B 5/04012 20130101; A61N 1/3702 20130101; A61B 5/0006 20130101;
A61B 5/686 20130101; A61B 5/0472 20130101; A61B 5/7465 20130101;
A61N 1/3756 20130101; G16H 40/67 20180101; A61B 5/0031 20130101;
A61B 5/0432 20130101; A61B 5/046 20130101; A61B 5/042 20130101;
A61B 5/746 20130101; A61B 5/0464 20130101; A61N 1/37258 20130101;
A61B 5/0456 20130101; A61B 5/02455 20130101 |
International
Class: |
A61B 5/0464 20060101
A61B005/0464; A61B 5/00 20060101 A61B005/00; A61B 5/0245 20060101
A61B005/0245; A61B 5/042 20060101 A61B005/042 |
Claims
1. A system for detecting cardiac events in a human patient, the
system including: at least two electrodes for obtaining an
electrical signal from the patient's heart; a processor configured
to detect at an emergency cardiac event, by processing the
electrical signal from the patient's heart; a patient alerting
mechanism connected to the processor for receiving an activation
signal from the processor dependent on said processor detection of
said cardiac event, the patient alerting mechanism being activated
by said activation signal, the patient alerting mechanism
configured for: responsive to said activation signal, emitting an
alarm signal having a first number of pulses within a first period
of time defining an initial alarm on-period; the initial alarm-on
period being followed by a respective alarm off-period of time
devoid of pulses, the patient alerting mechanism being further
configured to emit a reminder alarm signal periodically during a
predetermined reminder time period following the initial alarm
off-time period, wherein each of the reminder alarms occurs during
a reminder alarm on-period that is shorter than said first period
of time, and wherein the alarm-off period and the time between
periodic reminder alarms are both greater than said first period of
time, said patient alerting mechanism including a disabling
mechanism for disabling said reminder alarm.
2. The system of claim 1 where the periodic reminder time period is
greater than 15 minutes.
3. The system of claim 1 where the periodic reminder time period is
less than 5 hours.
4. The system of claim 1 where the alarm off-period of time is at
least twice as long as the alarm on-period.
5. The system of claim 1 where the alarm on-period is less than 10
minutes.
6. The system of claim 1 where at least a portion of the system is
implanted in the human patient.
7. The system of claim 1 where the cardiac events detected by the
system include acute myocardial infarction.
8. The system of claim 1 where the cardiac events detected by the
system include ischemia at an elevated heart rate.
9. The system of claim 1 where the cardiac events detected by the
system include low heart rate.
10. The system of claim 1 where the cardiac events detected by the
system include excessively high heart rate.
11. The system of claim 1 where the cardiac events detected by the
system include arrhythmias.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a Continuation of Ser. No. 14/499,942,
filed 29 Sep. 2014, currently pending, which is a Continuation of
Ser. No. 11/812,836, filed 22 Jun. 2007, now abandoned, which was a
Divisional of U.S. patent application Ser. No. 10/853,058, filed on
26 May 2004, which issued as U.S. Pat. No. 7,558,623 on 7 Jul.
2009.
FIELD OF USE
[0002] This invention is in the field of systems, including devices
implanted within a human patient, for the purpose of automatically
detecting the onset of a cardiac event.
BACKGROUND OF THE INVENTION
[0003] Heart disease is the leading cause of death in the United
States. A heart attack (also known as an Acute Myocardial
Infarction (AMI)) typically results from a thrombus that obstructs
blood flow in one or more coronary arteries. AMI is a common and
life-threatening complication of coronary heart disease. The sooner
that perfusion of the myocardium is restored (e.g., with injection
of a thrombolytic medication such as tissue plasminogen activator
(tPA)), the better the prognosis and survival of the patient from
the heart attack. The extent of damage to the myocardium is
strongly dependent upon the length of time prior to restoration of
blood flow to the heart muscle.
[0004] Myocardial ischemia is caused by a temporary imbalance of
blood (oxygen) supply and demand in the heart muscle. It is
typically provoked by physical activity or other causes of
increased heart rate when one or more of the coronary arteries are
obstructed by atherosclerosis. Patients will often (but not always)
experience chest discomfort (angina) when the heart muscle is
experiencing ischemia.
[0005] Acute myocardial infarction and ischemia may be detected
from a patient's electrocardiogram (ECG) by noting an ST segment
shift (i.e., voltage change) over a relatively short (less than 5
minutes) period of time. However, without knowing the patient's
normal ECG pattern detection from standard 12 lead ECG can be
unreliable. In addition, ideal placement of subcutaneous electrodes
for detection of ST segment shifts as they would relate to a
subcutaneously implanted device has not been explored in the prior
art.
[0006] Fischell et al in U.S. Pat. Nos. 6,112,116 and 6,272,379
describe implantable systems for detecting the onset of acute
myocardial infarction and providing both treatment and alarming to
the patient. While Fischell et al discuss the detection of a shift
in the S-T segment of the patient's electrogram from an electrode
within the heart as the trigger for alarms; it may be desirable to
provide more sophisticated detection algorithms to reduce the
probability of false positive and false negative detection. In
addition while these patents describe some desirable aspects of
programming such systems, it may be desirable to provide additional
programmability and alarm control features.
[0007] Although anti-tachycardia pacemakers and Implantable Cardiac
Defibrillators (ICDs) can detect heart arrhythmias, none are
currently designed to detect ischemia and acute myocardial
infarction events independently or in conjunction with
arrhythmias.
[0008] In U.S. Pat. Nos. 6,112,116 and 6,272,379 Fischell et al,
discuss the storage of recorded electrogram and/or
electrocardiogram data; however techniques to optimally store the
appropriate electrogram and/or electrocardiogram data and other
appropriate data in a limited amount of system memory are not
detailed.
[0009] In U.S. Pat. No. 5,497,780 by M. Zehender, a device is
described that has a "goal of eliminating . . . cardiac rhythm
abnormality." To do this, Zehender requires exactly two electrodes
placed within the heart and exactly one electrode placed outside
the heart. Although multiple electrodes could be used, the most
practical sensor for providing an electrogram to detect a heart
attack would use a single electrode placed within or near to the
heart.
[0010] Zehender's drawing of the algorithm consists of a single box
labeled ST SIGNAL ANALYSIS with no details of what the analysis
comprises. His only description of his detection algorithm is to
use a comparison of the ECG to a reference signal of a normal ECG
curve. Zehender does not discuss any details to teach an algorithm
by which such a comparison can be made, nor does Zehender explain
how one identifies the "normal ECG curve". Each patient will likely
have a different "normal" baseline ECG that will be an essential
part of any system or algorithm for detection of a heart attack or
ischemia.
[0011] In addition, Zehender suggests that an ST signal analysis
should be carried out every three minutes. It may be desirable to
use both longer and shorter time intervals than 3 minutes so as to
capture certain changes in ECG that are seen early on or later on
in the evolution of an acute myocardial infarction. Longer
observation periods will also be important to account for minor
slowly evolving changes in the "baseline" ECG. Zehender has no
mention of detection of ischemia having different normal curves
based on heart rate. To differentiate from exercise induced
ischemia and acute myocardial infarction, it may be important to
correlate ST segment shifts with heart rate or R-R interval.
[0012] Finally, Zehender teaches that "if an insufficient blood
supply in comparison to the reference signal occurs, the
corresponding abnormal ST segments can be stored in the memory in
digital form or as a numerical event in order to be available for
associated telemetry at any time." Storing only abnormal ECG
segments may miss important changes in baseline ECG. Thus it is
desirable to store some historical ECG segments in memory even if
they are not "abnormal".
[0013] The Reveal.TM. subcutaneous loop Holter monitor sold by
Medtronic uses two case electrodes spaced by about 3 inches to
record electrocardiogram information looking for arrhythmias. It
has no real capability to detect ST segment shift and its high pass
filtering would in fact preclude accurate detection of changes in
the low frequency aspects of the heart's electrical signal. Also
the spacing of the electrodes it too close together to be able to
effectively detect and record ST segment shifts. Similarly, current
external Holter monitors are primarily designed for capturing
arrhythmia related signals from the heart.
[0014] Although often described as an electrocardiogram (ECG), the
stored electrical signal from the heart as measured from electrodes
within the body should be termed an "electrogram". The early
detection of an acute myocardial infarction or exercise induced
myocardial ischemia caused by an increased heart rate or exertion
is feasible using a system that notes a change in a patient's
electrogram. The portion of such a system that includes the means
to detect a cardiac event is defined herein as a "cardiosaver" and
the entire system including the cardiosaver and the external
portions of the system is defined herein as a "guardian
system."
[0015] Furthermore, although the masculine pronouns "he" and "his"
are used herein, it should be understood that the patient or the
medical practitioner who treats the patient could be a man or a
woman. Still further the term; "medical practitioner" shall be used
herein to mean any person who might be involved in the medical
treatment of a patient. Such a medical practitioner would include,
but is not limited to, a medical doctor (e.g., a general practice
physician, an internist or a cardiologist), a medical technician, a
paramedic, a nurse or an electrogram analyst. A "cardiac event"
includes an acute myocardial infarction, ischemia caused by effort
(such as exercise) and/or an elevated heart rate, bradycardia,
tachycardia or an arrhythmia such as atrial fibrillation, atrial
flutter, ventricular fibrillation, and premature ventricular or
atrial contractions (PVCs or PACs).
[0016] For the purpose of this invention, the term
"electrocardiogram" is defined to be the heart electrical signals
from one or more skin surface electrode(s) that are placed in a
position to indicate the heart's electrical activity
(depolarization and repolarization). An electrocardiogram segment
refers to the recording of electrocardiogram data for either a
specific length of time, such as 10 seconds, or a specific number
of heart beats, such as 10 beats. For the purposes of this
specification the PQ segment of a patient's electrocardiogram is
the typically flat segment of a beat of an electrocardiogram that
occurs just before the R wave.
[0017] For the purpose of this invention, the term "electrogram" is
defined to be the heart electrical signals from one or more
implanted electrode(s) that are placed in a position to indicate
the heart's electrical activity (depolarization and
repolarization). An electrogram segment refers to the recording of
electrogram data for either a specific length of time, such as 10
seconds, or a specific number of heart beats, such as 10 beats. For
the purposes of this specification the PQ segment of a patient's
electrogram is the typically flat segment of an electrogram that
occurs just before the R wave. For the purposes of this
specification, the terms "detection" and "identification" of a
cardiac event have the same meaning. A beat is defined as a
sub-segment of an electrogram or electrocardiogram segment
containing exactly one R wave.
[0018] Heart signal parameters are defined to be any measured or
calculated value created during the processing of one or more beats
of electrogram data. Heart signal parameters include PQ segment
average value, ST segment average voltage value, R wave peak value,
ST deviation, ST shift, average signal strength, T wave peak
height, T wave average value, T wave deviation, heart rate, R-R
interval and peak-to-peak voltage amplitude.
SUMMARY OF THE INVENTION
[0019] The present invention is a system for the detection of
cardiac events (a guardian system) that includes a device called a
cardiosaver, and external equipment including a physician's
programmer and an external alarm system. The present invention
envisions a system for early detection of an acute myocardial
infarction or exercise induced myocardial ischemia caused by an
increased heart rate or exertion.
[0020] In the preferred embodiment of the present invention, the
cardiosaver is implanted along with the electrodes. In an alternate
embodiment, the cardiosaver and the electrodes could be external
but attached to the patient's body. Although the following
descriptions of the present invention in most cases refer to the
preferred embodiment of an implanted cardiosaver processing
electrogram data from implanted electrodes, the techniques
described are equally applicable to the alternate embodiment where
the external cardiosaver processes electrocardiogram data from skin
surface electrodes.
[0021] In the preferred embodiment of the cardiosaver either or
both subcutaneous electrodes or electrodes located on a pacemaker
type right ventricular or atrial leads will be used. It is also
envisioned that one or more electrodes may be placed within the
superior vena cava. One version of the implanted cardiosaver device
using subcutaneous electrodes would have an electrode located under
the skin on the patient's left side. This could be best located
between 2 and 20 inches below the patient's left arm pit. The
cardiosaver case that would act as the indifferent electrode would
typically be implanted like a pacemaker under the skin on the left
side of the patient's chest.
[0022] Using one or more detection algorithms, the cardiosaver can
detect a change in the patient's electrogram that is indicative of
a cardiac event, such as an acute myocardial infarction, within
five minutes after it occurs and then automatically warn the
patient that the event is occurring. To provide this warning, the
guardian system includes an internal alarm sub-system (internal
alarm means) within the cardiosaver and/or an external alarm system
(external alarm means). In the preferred, implanted embodiment, the
cardiosaver communicates with the external alarm system using a
wireless radio-frequency (RF) signal.
[0023] The internal alarm means generates an internal alarm signal
to warn the patient. The internal alarm signal may be a mechanical
vibration, a sound or a subcutaneous electrical tickle. The
external alarm system (external alarm means) will generate an
external alarm signal to warn the patient. The external alarm
signal is typically a sound that can be used alone or in
combination with the internal alarm signal. The internal or
external alarm signals would be used to alert the patient to at
least two different types of conditions (i.e. levels of severity):
an "EMERGENCY ALARM" signaling the detection of a major cardiac
event (e.g. a heart attack) and the need for immediate medical
attention, and a less critical "SEE DOCTOR ALERT" (or alarm)
signaling the detection of a less serious non life threatening
condition such as exercise induced ischemia. The SEE DOCTOR alert
signal would be used to tell the patient that he is not in
immediate danger but should arrange an appointment with his doctor
in the near future. In addition to the signaling of less critical
cardiac events, the SEE DOCTOR alert signal could also signal the
patient when the cardiosaver battery is getting low.
[0024] In the preferred embodiment, the internal EMERGENCY alarm
signal would be applied periodically, for example, with three
pulses every 5 seconds after the detection of a major cardiac
event. It is also envisioned that the less critical SEE DOCTOR
alert, would be signaled in a different way, such as one pulse
every 7 seconds.
[0025] The external alarm system is a hand-held portable device
that may include any or all of the following features:
[0026] 1. an external alarm means to generate an external alarm
signal to alert the patient.
[0027] 2. the capability to receive cardiac event alarms, recorded
electrogram and other data from the cardiosaver
[0028] 3. the capability to transmit the cardiac event alarm,
recorded electrogram and other data collected by the cardiosaver to
a medical practitioner at a remote location.
[0029] 4. an "alarm-off" or disable button that when depressed can
acknowledge that the patient is aware of the alarm and will turn
off internal and external alarm signals.
[0030] 5. a display (typically an LCD panel) to provide information
and/or instructions to the patient by a text message and the
display of segments of the patient's electrogram.
[0031] 6. the ability to provide messages including instructions to
the patient via a pre-recorded human voice.
[0032] 7. a patient initiated electrogram capture initiated by a
"Panic Button" to allow the patient, even when there has been no
alarm, to initiate transmission of electrogram data from the
cardiosaver to the external alarm system for transmission to a
medical practitioner.
[0033] 8. a patient initiated electrogram capture to initiate
transmission of electrogram data from the cardiosaver to the
external alarm system for display to a medical practitioner using
the display on the external alarm system.
[0034] 9. the capability to automatically turn the internal and
external alarms off after a reasonable (initial alarm-on) period
that is typically less than 30 minutes if the alarm-off button is
not used. This feature might also be implemented within the
cardiosaver implant.
[0035] If the alarm disable button is not used by the patient to
indicate acknowledgement of awareness of an EMERGENCY alarm, it is
envisioned that instead of completely stopping all alarm signals to
the patient after the first period of time which is an initial
alarm-on period, a reminder alarm signal would be turned on for a
second time period which is a reminder alarm on-period of time that
would follow an off-period of time during which time the alarm
signal is turned off.
[0036] The reminder alarm signal might be repeated periodically for
a third longer time period which is a periodic reminder time
period. Each of the repeated reminder alarm signals would last for
the reminder alarm on-period and would be followed by an alarm
off-period. The periodic reminder time period would typically be 3
to 5 hours because after three to five hours the patient's
advantage in being alerted to seek medical attention for a severe
cardiac event like an AMI is mostly lost. The alarm off-period
between the periodic reminder alarm signals could either remain
constant, increase or decrease over the periodic reminder time
period. For example, after an initial alarm-on time period of five
minutes a 30 second long reminder alarm signal might occur every 10
minutes for a periodic reminder time period of 3 hours, (i.e. the
reminder alarm on-period is 30 seconds and the alarm off-period is
9 minutes and 30 seconds). It is also envisioned that the alarm
off-period might change during the periodic reminder time period.
For example, the off-period in the first hour of the periodic
reminder time period might be 10 minutes increasing to 20 minutes
in the last hour of the periodic reminder time period.
[0037] Text and/or spoken instructions may include a message that
the patient should promptly take some predetermined medication such
as chewing an aspirin, placing a nitroglycerine tablet under his
tongue, inhaling or nasal spraying a single or multiple drug
combination and/or injecting thrombolytic drugs into a subcutaneous
drug port. The messaging displayed by or spoken from the external
alarm system and/or a phone call from a medical practitioner who
receives the alarm could also inform the patient that he should
wait for the arrival of emergency medical services or he should
promptly proceed to an emergency medical facility. It is envisioned
that the external alarm system can have direct connection to a
telephone line and/or work through cell phone or other wireless
networks.
[0038] If a patient seeks care in an emergency room, the external
alarm system could provide a display to the medical practitioners
in the emergency room of both the electrogram segment that caused
the alarm and the baseline electrogram segment against which the
electrogram that caused the alarm was compared. The ability to
display both baseline and alarm electrogram segments will
significantly improve the ability of the emergency room physician
to properly identify AMI.
[0039] A preferred embodiment of the external alarm system consists
of an external alarm transceiver and a handheld computer. The
external alarm transceiver having a standardized interface, such as
Compact Flash adapter interface, a secure digital (SD) card
interface, a multi-media card interface, a memory stick interface
or a PCMCIA card interface. The standardized interface will allow
the external alarm transceiver to connect into a similar
standardized interface slot that is present in many handheld
computers such as a Palm Pilot or Pocket PC. An advantage of this
embodiment is that the handheld computer can cost effectively
supply the capability for text and graphics display and for playing
spoken messages.
[0040] Using a handheld computer, such as the Thera.TM. by
Audiovox.TM. that combines a Pocket PC with having an SD/Multimedia
interface slot with a cell phone having wireless internet access,
is a solution that can easily be programmed to provide
communication between the external alarm system and a diagnostic
center staffed with medical practitioners.
[0041] The panic button feature, which allows a patient-initiated
electrogram capture and transmission to a medical practitioner,
will provide the patient with a sense of security knowing that, if
he detects symptoms of a heart-related ailment such as left arm
pain, chest pain or palpitations, he can get a fast review of his
electrogram. Such a review would allow the diagnosis of
arrhythmias, such as premature atrial or ventricular beats, atrial
fibrillation, atrial flutter or other heart rhythm irregularities.
The medical practitioner could then advise the patient what action,
if any, should be taken. The guardian system would also be
programmed to send an alarm in the case of ventricular fibrillation
so that a caretaker of the patient could be informed to immediately
provide a defibrillation electrical stimulus. This is practical as
home defibrillation units are now commercially available. It is
also possible that, in patients prone to ventricular fibrillation
following a myocardial infarction, such a home defibrillator could
be placed on the patient's chest to allow rapid defibrillation
should ventricular fibrillation occur while waiting for the
emergency medical services to arrive.
[0042] The physician's programmer provides the patient's doctor
with the capability to set cardiosaver cardiac event detection
parameters. The programmer communicates with the cardiosaver using
the wireless communication capability that also allows the external
alarm system to communicate with the cardiosaver. The programmer
can also be used to upload and review electrogram data captured by
the cardiosaver including electrogram segments captured before,
during and after a cardiac event.
[0043] An extremely important capability of the present invention
is the use of a continuously adapting cardiac event detection
program that compares extracted features from a recently captured
electrogram segment with the same features extracted from a
baseline electrogram segment at a predetermined time in the past.
For example, the thresholds for detecting an excessive ST shift
would be appropriately adjusted to account for slow changes in
electrode sensitivity or ST segment voltage levels over time. It
may also be desirable to choose the predetermined time in the past
for comparison to take into account daily cycles in the patient's
heart electrical signals. Thus, a preferred embodiment of the
present invention would use a baseline for comparison that is
collected approximately 24 hours prior to the electrogram segment
being examined. Such a system would adapt to both minor (benign)
slow changes in the patient's baseline electrogram as well as any
daily cycle.
[0044] Use of a system that adapts to slowly changing baseline
conditions is of great importance in the time following the
implantation of electrode leads in the heart. This is because there
can be a significant "injury current" present just after
implantation of an electrode and for a time of up to a month, as
the implanted electrode heals into the wall of the heart. Such an
injury current may produce a depressed ST segment that deviates
from a normal isoelectric electrogram where the PQ and ST segments
are at approximately the same voltage. Although the ST segment may
be depressed due to this injury current, the occurrence of an acute
myocardial infarction can still be detected since an acute
myocardial infarction will still cause a significant shift from
this "injury current" ST baseline electrogram. Alternately, the
present invention might be implanted and the detector could be
turned on after healing of the electrodes into the wall of the
heart. This healing would be noted in most cases by the evolution
to an isoelectric electrogram (i.e., PQ and ST segments with
approximately the same voltages).
[0045] The present invention's ST detection technique involves
recording and processing baseline electrogram segments to calculate
the threshold for myocardial infarction and/or ischemia detection.
These baseline electrogram segments would typically be collected,
processed and stored once an hour or with any other appropriate
time interval.
[0046] A preferred embodiment of the present invention would save
and process a 10 second baseline electrogram segment once every
hour. Every 30 seconds the cardiosaver would save and process a 10
second long recent electrogram segment. The cardiosaver would
compare the recent electrogram segment with the baseline
electrogram segment from approximately 24 hours before (i.e.
24.+-.1/2 hour before).
[0047] The processing of each of the hourly baseline electrogram
segments would involve calculating the average electrogram signal
strength as well as calculating the average "ST deviation". The ST
deviation for a single beat of an electrogram segment is defined to
be the difference between the average ST segment voltage and the
average PQ segment voltage. The average ST deviation of the
baseline electrogram segment is the average of the ST deviation of
multiple (at least two) beats within the baseline electrogram
segment.
[0048] The following detailed description of the drawings fully
describes how the ST and PQ segments are measured and averaged.
[0049] An important aspect of the present invention is the
capability to adjust the location in time and duration of the ST
and PQ segments used for the calculation of ST shifts. The present
invention is initially programmed with the time interval between
peak of the R wave of a beat and the start of the PQ and ST
segments of that beat set for the patient's normal heart rate. As
the patient's heart rate changes during daily activities, the
present invention will adjust these time intervals for each beat
proportional to the R-R interval for that beat. In other words, if
the R-R interval shortens (higher heart rate) then the ST and PQ
segments would move closer to the R wave peak and would become
shorter. ST and PQ segments of a beat within an electrogram segment
are defined herein as sub-segments of the electrogram segment.
Specifically, the time interval between the R wave and the start of
the ST and PQ segments may be adjusted in proportion to the R-R
interval or alternately by the square root of the R-R interval. It
is preferable in all cases to base these times on the R-R interval
from the beat before the current beat. As calculating the square
root is a processor intensive calculation, the preferred
implementation of this feature is best done by pre-calculating the
values for the start of PQ and ST segments during programming and
loading these times into a simple lookup table where for each R-R
interval, the start times and/or durations for the segments is
stored.
[0050] It is envisioned that a combination of linear and square
root techniques could be used where both the time interval between
the R wave and the start of the ST segment (T.sub.ST) and the
duration of the ST segment (D.sub.ST) are proportional to the
square root of the R-R interval, while the time interval between
the R wave and the start of the PQ segment (T.sub.PQ) and the
duration of the PQ segment (D.sub.PQ) are linearly proportional to
the R-R interval.
[0051] It is also envisioned that the patient would undergo a
stress test following implant, the electrogram data collected would
be transmitted to the physician's programmer and the parameters
T.sub.ST, D.sub.ST, T.sub.PQ and D.sub.PQ would be automatically
selected by the programmer based on the electrogram data from the
stress test. The data from the stress test would cover each of the
heart rate ranges and could also be used by the programmer to
generate excessive ST shift detection thresholds for each of the
heart rate ranges. In each heart rate range of the implant the
detection threshold would typically be set based on the mean and
standard deviation of the ST shifts seen during the stress test.
For example, one could set the detection threshold for each heart
rate range to the value of the mean ST shift plus or minus a
multiple (e.g. three) times the standard deviation. In each case
where the programmer can automatically select parameters for the ST
shift detection algorithm, a manual override would also be
available to the medical practitioner. Such an override is of
particular importance as it allows adjustment of the algorithm
parameters to compensate for missed events or false positive
detections.
[0052] The difference between the ST deviation on any single beat
in a recently collected electrogram segment and a baseline average
ST deviation extracted from a baseline electrogram segment is
defined herein as the "ST shift" for that beat. The present
invention envisions that detection of acute myocardial infarction
and/or ischemia would be based on comparing the ST shift of one or
more beats with a predetermined detection threshold "H.sub.ST".
[0053] In U.S. application Ser. No. 10/051,743 that is incorporated
herein by reference, Fischell describes a fixed threshold for
detection that is programmed by the patient's doctor. The present
invention envisions that the threshold should rather be based on
some percentage "P.sub.ST" of the average signal strength extracted
from the baseline electrogram segment where P.sub.ST is a
programmable parameter of the cardiosaver device. The "signal
strength" can be measured as peak-to-peak signal voltage, RMS
signal voltage or as some other indication of signal strength such
as the difference between the average PQ segment amplitude and the
peak R wave amplitude.
[0054] Similarly, it is envisioned that the value of P.sub.ST might
be adjusted as a function of heart rate so that a higher threshold
could be used if the heart rate is elevated, so as to not trigger
on exercise that in some patients will cause minor ST segment
shifts when there is not a heart attack occurring. Alternately,
lower thresholds might be used with higher heart rates to enhance
sensitivity to detect exercise-induced ischemia. One embodiment of
the present invention has a table stored in memory where values of
P.sub.ST for a preset number of heart rate ranges, (e.g. 50-80,
81-90, 91-100, 101-120, 121-140) might be stored for use by the
cardiosaver detection algorithm in determining if an acute
myocardial infarction or exercise induced ischemia is present.
[0055] Thus it is envisioned that the present invention would use
the baseline electrogram segments in 3 ways.
[0056] 1. To calculate a baseline average value of a feature such
as ST segment voltage or ST deviation that is then subtracted from
the value of the same feature in recently captured electrogram
segments to calculate the shift in the value of that feature. E.g.
the baseline average ST deviation is subtracted from the amplitude
of the ST deviation on each beat in a recently captured electrogram
segment to yield the ST shift for that beat.
[0057] 2. To provide an average signal strength used in calculating
the threshold for detection of a cardiac event. This will improve
detection by compensating for slow changes in electrogram signal
strength over relatively long periods of time.
[0058] 3. To provide a medical practitioner with information that
will facilitate diagnosis of the patient's condition. For example,
the baseline electrogram segment may be transmitted to a remotely
located medical practitioner and/or displayed directly to a medical
practitioner in the emergency room.
[0059] For the purposes of the present invention, the term adaptive
detection algorithm is hereby defined as a detection algorithm for
a cardiac event where at least one detection-related threshold
adapts over time so as to compensate for relatively slow (longer
than an hour) changes in the patient's normal electrogram.
[0060] The present invention might also include an accelerometer
built into the cardiosaver where the accelerometer is an activity
sensor used to discriminate between elevated heart rate resulting
from patient activity as compared to other causes.
[0061] It is also envisioned that the present invention could have
specific programming to identify a very low heart rate
(bradycardia) or a very high heart rate (tachycardia or
fibrillation). While a very low heart rate is usually not of
immediate danger to the patient, its persistence could indicate the
need for a pacemaker. As a result, the present invention could use
the "SEE DOCTOR" alert along with an optional message sent to the
external alarm system to alert the patient that his heart rate is
too low and that he should see his doctor as soon as convenient. On
the other hand, a very high heart rate can signal immediate danger
thus it would be desirable to initiate an EMERGENCY in a manner
similar to that of acute myocardial infarction detection. What is
more, detections of excessive ST shift during high heart rates may
be difficult and if the high heart rate is the result of a heart
attack then it is envisioned that the programming of the present
invention would use a major event counter that would turn on the
alarm if the device detects a combination of excessive ST shift and
overly high heart rate.
[0062] Another early indication of acute myocardial infarction is a
rapid change in the morphology of the T wave. Unfortunately, there
are many non-AMI causes of changes in the morphology of a T wave.
However, these changes typically occur slowly while the changes
from an AMI occur rapidly. Therefore one embodiment of this
invention uses detection of a change in the T wave as compared to a
baseline collected a short time (less than 30 minutes) in the past.
The best embodiment is probably using a baseline collected between
1 and 5 minutes in the past. Such a T wave detector could look at
the amplitude of the peak of the T wave. An alternate embodiment of
the T wave detector might look at the average value of the entire T
wave as compared to the baseline. The threshold for T wave shift
detection, like that of ST shift detection, can be a percentage
P.sub.T of the average signal strength of the baseline electrogram
segment. P.sub.T could differ from P.sub.ST if both detectors are
used simultaneously by the cardiosaver.
[0063] In its simplest form, the "guardian system" includes only
the cardiosaver and a physician's programmer. Although the
cardiosaver could function without an external alarm system where
the internal alarm signal stays on for a preset period of time, the
external alarm system is highly desirable. One reason it is
desirable is the button on the external alarm system that provides
the means for of turning off the alarm in either or both the
implanted device (cardiosaver) and the external alarm system.
Another very important function of the external alarm system is to
facilitate display of both the baseline and alarm electrogram
segments to a treating physician to facilitate rapid diagnosis and
treatment for the patient.
[0064] As an implantable device, the present invention cardiosaver
must conserve power to allow a reasonable lifetime in a
cosmetically acceptable package size. In U.S. Pat. No. 6,609,023,
Fischell et al describe how the cardiosaver collects and processes
electrogram data for a first predetermined, "segment time period"
(e.g. 10 seconds) to look for a cardiac event and then going to a
lower power usage sleep state for a second predetermined "sleep
state time period" (e.g. 20 seconds). Although it is desirable to
look for cardiac events every 30 seconds as described by Fischell
et al, it is possible to decrease the use of electrical power by
extending the time duration of the sleep state time period to be
greater than 20 seconds. Extending implant lifetime by decreasing
electrical power usage can be accomplished by utilizing a longer
time duration for the sleep state time period to be (for example)
on the order of 50 to 80 seconds.
[0065] While a 50 to 80 sleep state time period with a 10 second
time duration for the segment time period of data collection would
increase the life of the implant, the total cycle times of 60 to 90
seconds is a comparatively long time to wait if cardiac events are
to be quickly detected. The present invention cardiosaver utilizes
an adaptive cycle time where the sleep state time period following
detection of an "abnormal" electrogram segment is shorter than the
sleep state time period following detection of an electrogram
segment that has no detected abnormality. For example, the sleep
state time period could be 80 seconds following an electrogram
segment where no abnormality is detected and 20 seconds following
an electrogram segment where any abnormality (e.g. excessive ST
shift or arrhythmia) is detected. In this way, the function during
any irregularity of heart signal would be the same as the Fischell
et al. cardiosaver, yet significant power savings would be created
during normal functioning of the heart.
[0066] It is also envisioned that the sleep state time period could
be even more adaptive so that the length of the sleep state time
might be related to the number of successive normal (no abnormality
detected) electrogram segments. For example, one normal segment
would be followed by a sleep state time period of 40 seconds, two
normal segments by 50 seconds, 3 normal segments by 80 seconds, and
4 or more normal segments by 110 seconds. There would typically be
a maximum sleep state time period used during long periods when all
electrogram segments are normal and a minimum sleep time period
that would be used following any detected abnormality. The maximum
and minimum sleep times could be preset or programmable.
[0067] An abnormal electrogram segment is an electrogram segment
where one or more heart signal parameters extracted during the
processing of the electrogram segment by the cardiosaver meets the
criteria for an abnormal electrogram segment. The criteria for an
abnormal electrogram segment can be the same criteria used for
detecting a cardiac event within the electrogram segment. It is
also envisioned that the criteria for detecting an abnormal
electrogram segment could be less stringent that the criteria for
detecting a cardiac event. For example, an abnormal segment might
be detected using a threshold lower by a preset percentage (e.g.
50%) than the respective threshold for the indication of a cardiac
event. In this way, the time to detection of the event might be
reduced by getting to the shorter sleep time more quickly.
[0068] It is also highly desirable for the present invention
guardian system to allow real time or near real time display of
electrogram data for diagnostic purposes. Such a display could be
of great value in an emergency setting where fast review of the
patient's current heart signal is important. In a real time mode,
the cardiosaver 5 of FIG. 1 would simultaneously collect and
transmit electrogram data to the external equipment 7 of FIG.
1.
[0069] In the near real time mode, the cardiosaver 5 would collect
an electrogram segment, process the electrogram segment looking for
abnormalities and then transmit the segment to the external
equipment 7. A typical cycle time for the near real time mode would
be 15 seconds including 10 seconds for electrogram segment
collection, 1 second for processing and 4 seconds for transmission
to the external equipment 7. The results of the processing might
also be transmitted along with the segment.
[0070] Thus it is an object of this invention is to have a
cardiosaver designed to detect the occurrence of a cardiac event by
comparing baseline electrogram data from a first predetermined time
with recent electrogram data from a second predetermined time.
[0071] Another object of the present invention is to have a
Guardian system where the electrogram data collected during a
preset period (such as during a stress test) is used by the
programmer to automatically select detection parameters for the ST
shift detection algorithm.
[0072] Another object of the present invention is to have a
Guardian system with at least two levels of severity of patient
alarm/alerting where the more severe EMERGENCY alarm alerts the
patient to seek immediate medical attention.
[0073] Another object of the present invention is to have a cardiac
event detected by comparing at least one heart signal parameter
extracted from an electrogram segment captured at a first
predetermined time by an implantable cardiosaver with the same at
least one heart signal parameter extracted from an electrogram
segment captured at a second predetermined time.
[0074] Another object of the present invention is to have acute
myocardial infarction detected by comparing recent electrogram data
to baseline electrogram data from the same time of day (i.e.
approximately 24 hours in the past).
[0075] Another object of the present invention is to have acute
myocardial infarction detected by comparing the ST deviation of the
beats in a recently collected electrogram segment to the average ST
deviation of two or more beats of a baseline electrogram segment.
Another object of the present invention is to have acute myocardial
infarction detected by comparing the ST segment voltage of the
beats in a recently collected electrogram segment to the average ST
segment voltage of two or more beats of a baseline electrogram
segment.
[0076] Another object of the present invention is to have the
threshold(s) for detecting the occurrence of a cardiac event
adjusted by a cardiosaver device to compensate for slow changes in
the average signal level of the patient's electrogram.
[0077] Another object of the present invention is to have the
threshold for detection of a cardiac event adjusted by a
cardiosaver device to compensate for daily cyclic changes in the
average signal level of the patient's electrogram.
[0078] Another object of the present invention is to have an
external alarm system including an alarm off button that will turn
off either or both internal and external alarm signals initiated by
an implanted cardiosaver.
[0079] Another object of the present invention is to have the alarm
signal generated by a cardiosaver automatically turn off after a
preset period of time.
[0080] Still another object of this invention is to use the
cardiosaver to warn the patient that an acute myocardial infarction
has occurred by means of a subcutaneous vibration.
[0081] Still another object of this invention is to have the
cardiac event detection require that at least a majority of the
beats exhibit an excessive ST shift before identifying an acute
myocardial infarction.
[0082] Still another object of this invention is to have the
cardiac event detection require that excessive ST shift still be
present in at least two electrogram segments separated by a preset
period of time.
[0083] Still another object of this invention is to have the
cardiac event detection require that excessive ST shift still be
present in at. least three electrogram segments separated by preset
periods of time.
[0084] Yet another object of the present invention is to have a
threshold for detection of excessive ST shift that is dependent
upon the average signal strength calculated from a baseline
electrogram segment.
[0085] Yet another object of the present invention is to have a
threshold for detection of excessive ST shift that is a function of
the difference between the average PQ segment amplitude and the R
wave peak amplitude of a baseline electrogram segment.
[0086] Yet another object of the present invention is to have a
threshold for detection of excessive ST shift that is a function of
the average minimum to maximum (peak-to-peak) voltage for at least
two beats calculated from a baseline electrogram segment.
[0087] Yet another object of the present invention is to have the
ability to detect a cardiac event by the shift in the amplitude of
the T wave of an electrogram segment at a second predetermined time
as compared with the average baseline T wave amplitude from a
baseline electrogram segment at a first predetermined time.
[0088] Yet another object of the present invention is to have the
ability to detect a cardiac event by the shift in the T wave
deviation of at least one beat of an electrogram segment at a
second predetermined time as compared with the average baseline T
wave deviation from an electrogram segment at a first predetermined
time.
[0089] Yet another object of the present invention is to have the
first and second predetermined times for T wave amplitude and/or
deviation comparison be separated by less than 30 minutes.
[0090] Yet another object of the present invention is to have the
baseline electrogram segment used for ST segment shift detection
and the baseline electrogram segment used for T wave shift
detection be collected at different times.
[0091] Yet another object of the present invention is to have an
initial alarm-on patient alerting period followed by a reminder
alarm that periodically cycles on and off over a periodic reminder
alarm period.
[0092] Yet another object of the present invention is to have an
individualized (patient specific) "normal" heart rate range such
that the upper and lower limits of "normal" are programmable using
the cardiosaver programmer.
[0093] Yet another object of the present invention is to have one
or more individualized (patient specific) "elevated" heart rate
ranges such that the upper and lower limits of each "elevated"
range are programmable using the cardiosaver programmer.
[0094] Yet another object of the present invention is to allow the
threshold for detection of an excessive ST shift be different for
the "normal" heart rate range as compared to one or more "elevated"
heart rate ranges.
[0095] Yet another object of the present invention is to allow real
time or near real time display of electrogram data for diagnostic
purposes.
[0096] Yet another object of the present invention is to have the
time period between collections of electrogram data vary, where the
time period is lengthened when the electrogram is normal and
shortened when the electrogram is abnormal.
[0097] Yet another object of the present invention is to have
different criteria for the normal/abnormal electrogram decision
that influences the time period between collections of electrogram
data as compared with the criteria for detecting a cardiac
event.
[0098] These and other objects and advantages of this invention
will become obvious to a person of ordinary skill in this art upon
reading of the detailed description of this invention including the
associated drawings as presented herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0099] FIG. 1 illustrates a guardian system for the detection of a
cardiac event and for warning the patient that a cardiac event is
occurring.
[0100] FIG. 2 illustrates a normal electrogram pattern and also
shows a superimposed elevated ST segment that would be indicative
of an acute myocardial infarction.
[0101] FIG. 3 is a plan view of the cardiosaver showing the
cardiosaver electronics module and two electrical leads each having
one electrode.
[0102] FIG. 4 is a block diagram of the cardiosaver.
[0103] FIG. 5 is a block diagram of the cardiosaver event detection
program.
[0104] FIG. 6 illustrates the extracted electrogram segment
features used to calculate ST shift.
[0105] FIG. 7 is a block diagram of the baseline parameter
extraction subroutine of the cardiosaver event detection
program.
[0106] FIG. 8 is a block diagram of the alarm subroutine of the
cardiosaver event detection program.
[0107] FIG. 9 is a block diagram of the hi/low heart rate
subroutine of the cardiosaver event detection program.
[0108] FIG. 10 is a block diagram of the ischemia subroutine of the
cardiosaver event detection program
[0109] FIG. 11 is a diagram of the conditions that trigger
cardiosaver alarms.
[0110] FIG. 12 is a block diagram of the unsteady heart rate
subroutine of the cardiosaver event detection program.
[0111] FIG. 13 is an alternate embodiment of the guardian
system.
[0112] FIG. 14 illustrates the preferred physical embodiment of the
external alarm transceiver.
[0113] FIG. 15 illustrates the physical embodiment of the combined
external alarm transceiver and pocket PC, and FIG. 16 is a block
diagram of an embodiment of an external alarm transceiver.
DETAILED DESCRIPTION OF THE INVENTION
[0114] FIG. 1 illustrates one embodiment of the guardian system 10
consisting of an implanted cardiosaver 5 and external equipment 7.
The battery powered cardiosaver 5 contains electronic circuitry
that can detect a cardiac event such as an acute myocardial
infarction or arrhythmia and warn the patient when the event
occurs. The cardiosaver 5 can store the patient's electrogram for
later readout and can send wireless signals 53 to and receive
wireless signals 54 from the external equipment 7. The functioning
of the cardiosaver 5 will be explained in greater detail with the
assistance of FIG. 4.
[0115] The cardiosaver 5 has two leads 12 and 15 that have
multi-wire electrical conductors with surrounding insulation. The
lead 12 is shown with two electrodes 13 and 14. The lead 15 has
subcutaneous electrodes 16 and 17. In fact, the cardiosaver 5 could
utilize as few as one lead or as many as three and each lead could
have as few as one electrode or as many as eight electrodes.
Furthermore, electrodes 8 and 9 could be placed on the outer
surface of the cardiosaver 5 without any wires being placed
externally to the cardiosaver 5.
[0116] The lead 12 in FIG. 1 could advantageously be placed through
the patient's vascular system with the electrode 14 being placed
into the apex of the right ventricle. The lead 12 with electrode 13
could be placed in the right ventricle or right atrium or the
superior vena cava similar to the placement of leads for pacemakers
and Implantable Coronary Defibrillators (ICDs). The metal case 11
of the cardiosaver 5 could serve as an indifferent electrode with
either or both electrodes 13 and/or 14 being active electrodes. It
is also conceived that the electrodes 13 and 14 could be used as
bipolar electrodes. Alternately, the lead 12 in FIG. 1 could
advantageously be placed through the patient's vascular system with
the electrode 14 being placed into the apex of the left ventricle.
The electrode 13 could be placed in the left atrium.
[0117] The lead 15 could advantageously be placed subcutaneously at
any location where the electrodes 16 and/or 17 would provide a good
electrogram signal indicative of the electrical activity of the
heart. Again for this lead 15, the case 11 of the cardiosaver 5
could be an indifferent electrode and the electrodes 16 and/or 17
could be active electrodes or electrodes 16 and 17 could function
together as bipolar electrodes. The cardiosaver 5 could operate
with only one lead and as few as one active electrode with the case
of the cardiosaver 5 being an indifferent electrode. The guardian
system 10 described herein can readily operate with only two
electrodes.
[0118] One embodiment of the cardiosaver device 5 using
subcutaneous lead 15 would have the electrode 17 located under the
skin on the patient's left side. This could be best located between
2 and 20 inches below the patient's left arm pit. The cardiosaver
case 11 could act as the indifferent electrode and would typically
be implanted under the skin on the left side of the patient's
chest.
[0119] FIG. 1 also shows the external equipment 7 that consists of
a physician's programmer 68 having an antenna 70, an external alarm
system 60 including a charger 166. The external equipment 7
provides means to interact with the cardiosaver 5. These
interactions include programming the cardiosaver 5, retrieving data
collected by the cardiosaver 5 and handling alarms generated by the
cardiosaver 5.
[0120] The purpose of the physician's programmer 68 shown in FIG. 1
is to set and/or change the operating parameters of the implantable
cardiosaver 5 and to read out data stored in the memory of the
cardiosaver 5 such as stored electrogram segments. This would be
accomplished by transmission of a wireless signal 54 from the
programmer 68 to the cardiosaver 5 and receiving of telemetry by
the wireless signal 53 from the cardiosaver 5 to the programmer 68.
When a laptop computer is used as the physician's programmer 68, it
would require connection to a wireless transceiver for
communicating with the cardiosaver 5. Such a transceiver could be
connected via a standard interface such as a USB, serial or
parallel port or it could be inserted into the laptop's PCMCIA card
slot. The screen on the laptop would be used to provide guidance to
the physician in communicating with the cardiosaver 5. Also, the
screen could be used to display both real time and stored
electrograms that are read out from the cardiosaver 5.
[0121] In FIG. 1, the external alarm system 60 has a patient
operated initiator 55, an alarm disable button 59, a panic button
52, an alarm transceiver 56, an alarm speaker 57 and an antenna 161
and can communicate with emergency medical services 67 with the
modem 165 via the communication link 65.
[0122] If a cardiac event is detected by the cardiosaver 5, an
alarm message is sent by a wireless signal 53 to the alarm
transceiver 56 via the antenna 161. When the alarm is received by
the alarm transceiver 56 a signal 58 is sent to the loudspeaker 57.
The signal 58 will cause the loudspeaker to emit an external alarm
signal 51 to warn the patient that an event has occurred. Examples
of external alarm signals 51 include a periodic buzzing, a sequence
of tones and/or a speech message that instructs the patient as to
what actions should be taken. Furthermore, the alarm transceiver 56
can, depending upon the nature of the signal 53, send an outgoing
signal over the link 65 to contact emergency medical services 67.
When the detection of an acute myocardial infarction is the cause
of the alarm, the alarm transceiver 56 could automatically notify
emergency medical services 67 that a heart attack has occurred and
an ambulance could be sent to treat the patient and to bring him to
a hospital emergency room.
[0123] If the remote communication with emergency medical services
67 is enabled and a cardiac event alarm is sent within the signal
53, the modem 165 will establish the data communications link 65
over which a message will be transmitted to the emergency medical
services 67. The message sent over the link 65 may include any or
all of the following information: (1) a specific patient is having
an acute myocardial infarction or other cardiac event, (2) the
patient's name, address and a brief medical history, (3) a map
and/or directions to where the patient is located, (4) the
patient's stored electrogram including baseline electrogram data
and the specific electrogram segment that generated the alarm (5)
continuous real time electrogram data, and (6) a prescription
written by the patient's personal physician as to the type and
amount of drug to be administered to the patient in the event of a
heart attack. If the emergency medical services 67 includes an
emergency room at a hospital, information can be transmitted that
the patient has had a cardiac event and should be on his way to the
emergency room. In this manner the medical practitioners at the
emergency room could be prepared for the patient's arrival.
[0124] The communications link 65 can be either a wired or wireless
telephone connection that allows the alarm transceiver 56 to call
out to emergency medical services 67. The typical external alarm
system 60 might be built into a Pocket PC or Palm Pilot PDA where
the alarm transceiver 56 and modem 165 are built into insertable
cards having a standardized interface such as compact flash cards,
PCMCIA cards, multimedia, memory stick or secure digital (SD)
cards. The modem 165 can be a wireless modem such as the Sierra
AirCard 300 or the modem 165 may be a wired modem that connects to
a standard telephone line. The modem 165 can also be integrated
into the alarm transceiver 56.
[0125] The purpose of the patient operated initiator 55 is to give
the patient the capability for initiating transmission of the most
recently captured electrogram segment from the cardiosaver 5 to the
external alarm system 60. This will enable the electrogram segment
to be displayed for a medical practitioner.
[0126] Once an internal and/or external alarm signal has been
initiated, depressing the alarm disable button 59 will acknowledge
the patient's awareness of the alarm and turn off the internal
alarm signal generated within the cardiosaver 5 and/or the external
alarm signal 51 played through the speaker 57. If the alarm disable
button 59 is not used by the patient to indicate acknowledgement of
awareness of a SEE DOCTOR alert or an EMERGENCY alarm, it is
envisioned that the internal and/or external alarm signals would
stop after a first time period (an initial alarm-on period) that
would be programmable through the programmer 68.
[0127] For EMERGENCY alarms, to help prevent a patient ignoring or
sleeping through the alarm signals generated during the initial
alarm-on period, a reminder alarm signal might be turned on
periodically during a follow-on periodic reminder time period. This
periodic reminder time is typically much longer than the initial
alarm-on period. The periodic reminder time period would typically
be 3 to 5 hours because after 3 to 5 hours the patient's advantage
in being alerted to seek medical attention for a severe cardiac
event like an AMI is mostly lost. It is also envisioned that the
periodic reminder time period could also be programmable through
the programmer 68 to be as short as 5 minutes or even continue
indefinitely until the patient acknowledges the alarm signal with
the button 59 or the programmer 68 is used to interact with the
cardiosaver 5.
[0128] Following the initial alarm on-period there would be an
alarm off-period followed by a reminder alarm on-period followed by
an alarm off-period followed by another reminder alarm on-period
and so on periodically repeating until the end of the periodic
reminder time period.
[0129] The alarm off-period time interval between the periodic
reminders might also increase over the reminder alarm on-period.
For example, the initial alarm-on period might be 5 minutes and for
the first hour following the initial alarm-on period, a reminder
signal might be activated for 30 seconds every 5 minutes. For the
second hour the reminder alarm signal might be activated for 20
seconds every 10 minutes and for the remaining hours of the
periodic reminder on-period the reminder alarm signal might be
activated for 30 seconds every 15 minutes.
[0130] The patient might press the panic button 52 in the event
that the patient feels that he is experiencing a cardiac event. The
panic button 52 will initiate the transmission from the cardiosaver
5 to the external alarm system 60 via the wireless signal 53 of
both recent and baseline electrogram segments. The external alarm
system 60 will then retransmit these data via the link 65 to
emergency medical services 67 where a medical practitioner will
view the electrogram data. The remote medical practitioner could
then analyze the electrogram data and call the patient back to
offer advice as to whether this is an emergency situation or the
situation could be routinely handled by the patient's personal
physician at some later time.
[0131] It is envisioned that there may be preset limits within the
external alarm system 60 that prevent the patient operated
initiator 55 and/or panic button from being used more than a
certain number of times a day to prevent the patient from running
down the batteries in the cardiosaver 5 and external alarm system
60 as wireless transmission takes a relatively large amount of
power as compared with other functional operation of these
devices.
[0132] FIG. 2 illustrates a typical electrogram signal having beats
1 and 2 from some pair of implanted electrodes such as the
electrode 14 and the case 11 of FIG. 3 overlaid with an electrogram
having an elevated ST segment 4 (dashed line). The various portions
of the electrogram are shown as the P, Q, R, S, and T waves. These
are all shown as portions of a solid line in FIG. 2. The normal ST
segment 3 of beat 2 is also shown in FIG. 2. The R-R interval 5 for
beat 2 is shown as the time between the R waves of beat 2 and the
beat before it (beat 1).
[0133] When an acute myocardial infarction occurs, there is
typically an elevation (or depression) of the ST segment 4 as shown
by the dashed line in FIG. 2. It is this shift of the ST segment 4
as compared to the baseline ST segment 3 that is a clear indicator
that an acute myocardial infarction has occurred in a significant
portion of the patient's myocardium.
[0134] Although an elevated ST segment 4 can be a good indicator of
an acute myocardial infarction, other indicators such as a sudden
change of heart rate or heart wall motion, intra-coronary blood
pressure or a sudden decrease in blood PO.sub.2 could also be used
as independent sensing means or those signals could be used in
addition to the voltage shift of the ST segment 4.
[0135] It is important to note that the electrogram from implanted
electrodes may provide a faster detection of an ST segment shift as
compared to an electrocardiogram signal obtained from skin surface
electrodes. Thus the electrogram from implanted electrodes as
described herein is the preferred embodiment of the present
invention.
[0136] It is also well known that the T wave can shift very quickly
when a heart attack occurs. It is envisioned that the present
invention might detect this T wave shift as compared to a time of 1
to 5 minutes in the past.
[0137] It is anticipated that when a patient who has a stenosis in
a coronary artery is performing a comparatively strenuous exercise
his heart rate increases and he can develop exercise induced
ischemia that will also result in a shift of the ST segment of his
electrogram. This is particularly true for patients who have
undergone balloon angioplasty with or without stent implantation.
Such patients will be informed by their own physician that, if
their cardiosaver 5 of FIG. 1 activates an alarm during exercise,
that it may be indicative of the progression of an arterial
stenosis in one of the heart's arteries. Such a patient would be
advised to stop all exertion immediately and if the alarm signal
goes away as his heart rate slows, the patient should see his
doctor as soon as convenient. If the alarm signal does not go away
as the patient's heart rate slows down into the normal range then
the cardiosaver will change the alarm signal to indicate that the
patient should immediately seek medical care. As previously
described, the cardiosaver 5 could emit a different signal if there
is a heart attack as compared to the signal that would be produced
if there were ischemia resulting from exercise.
[0138] It is also envisioned that heart rate and the rate of change
of heart rate experienced during an ST segment voltage shift can be
used to indicate which alarm should be produced by the cardiosaver
5. Specifically, an ST segment shift at a near normal heart rate
would indicate an acute myocardial infarction. An ST segment shift
when there is an elevated heart rate (e.g., greater than 100 bpm)
would generally be indicative of a progressing stenosis in a
coronary artery. In any case, if a sufficient ST segment shift
occurs that results in an alarm from the cardiosaver 5, the patient
should promptly seek medical care to determine the cause of the
alarm.
[0139] It should be understood that, depending on a patient's
medical condition, a vigorous exercise might be as energetic as
running a long distance or merely going up a flight of stairs.
After the cardiosaver 5 is implanted in a patient who has undergone
a stent implant, he should have a stress test to determine his
level of ST segment shift that is associated with the highest level
of exercise that he can attain. The patient's heart rate should
then be noted and the cardiosaver thresholds for detection,
described with FIGS. 5 through 9, should be programmed so as to not
alarm at ST segment shifts observed during exercise. Then if at a
later time the patient experiences an increased shift of his ST
segment at that pre-determined heart rate or within a heart rate
range, then an alarm indicating ischemia can be programmed to
occur. The occurrence of such an alarm can indicate that there is a
progression in the narrowing of some coronary artery that may
require angiography to determine if angioplasty, possibly including
stent implantation, is required.
[0140] The alarm signal associated with an excessive ST shift
caused by an acute myocardial infarction can be quite different
from the "SEE DOCTOR" alarm means associated with progressing
ischemia during exercise. For example, the SEE DOCTOR alert signal
might be an audio signal that occurs once every 5 to 10 seconds. A
different alarm signal, for example an audio signal that is three
buzzes every 3 to 5 seconds, may be used to indicate a major
cardiac event such as an acute myocardial infarction. Similar alarm
signal timing would typically be used for both internal alarm
signals generated by the alarm sub-system 48 of FIG. 4 and external
alarm signals generated by the external alarm system 60.
[0141] In any case, a patient can be taught to recognize which
signal occurs for these different circumstances so that he can take
immediate response if an acute myocardial infarction is indicated
but can take a non-emergency response if progression of the
narrowing of a stenosis or some other less critical condition is
indicated. It should be understood that other distinctly different
audio alarm patterns could be used for different arrhythmias such
as atrial fibrillation, atrial flutter, PVC's, PAC's, etc. A
capability of the physician's programmer 68 of FIG. 1 would be to
program different alarm signal patterns, enable or disable
detection and/or generation of associated alarm signals in the
cardiosaver for any one or more of these various cardiac events.
Also, the intensity of the audio alarm, vibration or electrical
tickle alarm could be adjusted to suit the needs of different
patients. In order to familiarize the patient with the different
alarm signals, the programmer 68 of the present invention would
have the capability to turn each of the different alarm signals on
and off.
[0142] FIG. 3 is a plan view of the cardiosaver 5 having a case 11
and a plastic header 20. The case 11 contains the primary battery
22 and the electronics module 18. This type of package is well
known for pacemakers, implantable defibrillators and implantable
tissue stimulators. Electrical conductors placed through the
plastic header 20 connect the electronics module 18 to the
electrical leads 12 and 15, which have respectively electrodes 14
and 17. The on-case electrodes 8 and 9 of FIG. 1 are not shown in
FIG. 3. It should also be understood that the cardiosaver 5 can
function with only two electrodes, one of which could be the case
11. All the different configurations for electrodes shown in FIGS.
1 and 3, such as the electrodes 8, 9, 13, 14, 16 or the metal case
11 are shown only to indicate that there are a variety of possible
electrode arrangements that can be used with the cardiosaver 5.
[0143] On the metal case 11, a conducting disc 31 mounted onto an
insulating disc 32 can be used to provide a subcutaneous electrical
tickle to warn the patient that an acute myocardial infarction is
occurring or to act as an independent electrode.
[0144] FIG. 4 is a block diagram of the cardiosaver 5 with primary
battery 22 and a secondary battery 24. The secondary battery 24 is
typically a rechargeable battery of smaller capacity but higher
current or voltage output than the primary battery 22 and is used
for short term high output components of the cardiosaver 5 like the
RF chipset in the telemetry sub-system 46 or the vibrator 25
attached to the alarm sub-system 48. An important feature of the
present invention. cardiosaver is the dual battery configuration
where the primary battery 22 will charge the secondary battery 24
through the charging circuit 23. The primary battery 22 is
typically a larger capacity battery than the secondary battery 24.
The primary battery also typically has a lower self discharge rate
as a percentage of its capacity than the secondary battery 24. It
is also envisioned that the secondary battery could be charged from
an external induction coil by the patient or by the doctor during a
periodic check-up.
[0145] The electrodes 14 and 17 connect with wires 12 and 15
respectively to the amplifier 36 that is also connected to the case
11 acting as an indifferent electrode. As two or more electrodes 12
and 15 are shown here, the amplifier 36 would be a multi-channel
amplifier. The amplified electrogram signals 37 from the amplifier
36 are then converted to digital signals 38 by the
analog-to-digital converter 41. The digital electrogram signals 38
are buffered in the First-In-First-Out (FIFO) memory 42. Processor
means shown in FIG. 4 as the central processing unit (CPU) 44
coupled to memory means shown in FIG. 4 as the Random Access Memory
(RAM) 47 can process the digital electrogram data 38 stored the
FIFO 42 according to the programming instructions stored in the
program memory 45. This programming (i.e. software) enables the
cardiosaver 5 to detect the occurrence of a cardiac event such as
an acute myocardial infarction.
[0146] A clock/timing sub-system 49 provides the means for timing
specific activities of the cardiosaver 5 including the absolute or
relative time stamping of detected cardiac events. The clock/timing
sub-system 49 can also facilitate power savings by causing
components of the cardiosaver 5 to go into a low power standby mode
in between times for electrogram signal collection and processing.
Such cycled power savings techniques are often used in implantable
pacemakers and defibrillators. In an alternate embodiment, the
clock/timing sub-system can be provided by a program subroutine run
by the central processing unit 44.
[0147] In an advanced embodiment of the present invention, the
clock/timing circuitry 49 would count for a first period (e.g. 20
seconds) then it would enable the analog-to-digital converter 41
and FIFO 42 to begin storing data, after a second period (e.g. 10
seconds) the timing circuitry 49 would wake up the CPU 44 from its
low power standby mode. The CPU 44 would then process the 10
seconds of data in a very short time (typically less than a second)
and go back to low power mode. This would allow an on off duty
cycle of the CPU 44 which often draws the most power of less than 2
seconds per minute while actually collecting electrogram data for
20 seconds per minute.
[0148] In a preferred embodiment of the present invention the RAM
47 includes specific memory locations for 3 sets of electrogram
segment storage. These are the recent electrogram storage 472 that
would store the last 2 to 10 minutes of recently recorded
electrogram segments so that the electrogram data leading in the
period just before the onset of a cardiac event can be reviewed at
a later time by the patient's physician using the physician's
programmer 68 of FIG. 1. For example, the recent electrogram
storage 472 might contain eight 10 second long electrogram segments
that were captured every 30 seconds over the last 4 minutes.
[0149] The baseline electrogram memory 474 would provide storage
for baseline electrogram segments collected at preset times over
one or more days. For example, the baseline electrogram memory 474
might contain 24 baseline electrogram segments of 10 seconds
duration, one from each hour for the last day.
[0150] The event memory 476 occupies the largest part of the RAM
47. The event memory 476 is not overwritten on a regular schedule
as are the recent electrogram memory 472 and baseline electrogram
memory 474 but is typically maintained until read out by the
patient's physician with the programmer 68 of FIG. 1. At the time a
cardiac event like excessive ST shift indicating an acute
myocardial infarction is detected by the CPU 44, all (or part) of
the entire contents of the baseline and recent electrogram memories
472 and 474 would typically be copied into the event memory 476 so
as to save the pre-event data for later physician review.
[0151] In the absence of events, the event memory 476 could be used
temporarily to extend the recent electrogram memory 472 so that
more data (e.g. every 10 minutes for the last 12 hours) could be
held by the cardiosaver 5 of FIG. 1 to be examined by a medical
practitioner at the time a patient visits. This would typically be
overwritten with pre- and post-event electrogram segments following
a detected event.
[0152] An example of use of the event memory 476 would have a SEE
DOCTOR alert saving the last segment that triggered the alarm and
the baseline used by the detection algorithm in detecting the
abnormality. An EMERGENCY ALARM would save the sequential segments
that triggered the alarm, a selection of other pre-event
electrogram segments, or a selection of the 24 baseline electrogram
segments and post-event electrogram segments. For example, the
pre-event memory would have baselines from -24 hrs, -18, -12, -6,
-5, -4, -3, -2 and -1 hours, recent electrogram segments (other
than the triggering segments) from -5 minutes, -10, -20, -35, and
-50 minutes, and post-event electrogram segments for every 5
minutes for the 2 hours following the event and for every 15
minutes after 2 hours post-event. These settings could be pre-set
or programmable. The RAM 47 also contains memory sections for
programmable parameters 471 and calculated baseline data 475. The
programmable parameters 471 include the upper and lower limits for
the normal and elevated heart rate ranges, and physician programmed
parameters related to the cardiac event detection processes stored
in the program memory 45. The calculated baseline data 475 contain
detection parameters extracted from the baseline electrogram
segments stored in the baseline electrogram memory 474. Calculated
baseline data 475 and programmable parameters 471 would typically
be saved to the event memory 476 following the detection of a
cardiac event. The RAM 47 also includes patient data 473 that may
include the patient's name, address, telephone number, medical
history, insurance information, doctor's name, and specific
prescriptions for different medications to be administered by
medical practitioners in the event of different cardiac events.
[0153] It is envisioned that the cardiosaver 5 could also contain
pacemaker circuitry 170 and/or defibrillator circuitry 180 similar
to the cardiosaver systems described by Fischell in U.S. Pat. No.
6,240,049.
[0154] The alarm sub-system 48 contains the circuitry and
transducers to produce the internal alarm signals for the
cardiosaver 5. The internal alarm signal can be a mechanical
vibration, a sound or a subcutaneous electrical tickle or
shock.
[0155] The telemetry sub-system 46 with antenna 35 provides the
cardiosaver 5 the means for two-way wireless communication to and
from the external equipment 7 of FIG. 1. Existing radiofrequency
transceiver chip sets such as the Ash transceiver hybrids produced
by RF Microdevices, Inc. can readily provide such two-way wireless
communication over a range of up to 10 meters from the patient. It
is also envisioned that short range telemetry such as that
typically used in pacemakers and defibrillators could also be
applied to the cardiosaver 5. It is also envisioned that standard
wireless protocols such as Bluetooth and 802.11a or 802.11b might
be used to allow communication with a wider group of peripheral
devices.
[0156] A magnet sensor 190 may be incorporated into the cardiosaver
5. An important use of the magnet sensor 190 is to turn on the
cardiosaver 5 on just before programming and implantation. This
would reduce wasted battery life in the period between the times
that the cardiosaver 5 is packaged at the factory until the day it
is implanted.
[0157] The cardiosaver 5 might also include an accelerometer 175.
The accelerometer 174 together with the processor 44 is designed to
monitor the level of patient activity and identify when the patient
is active. The activity measurements are sent to the processor 44.
In this embodiment the processor 44 can compare the data from the
accelerometer 175 to a preset threshold to discriminate between
elevated heart rate resulting from patient activity as compared to
other causes.
[0158] FIG. 5 illustrates in the form of a block diagram the
operation of the heart signal processing program 450 for cardiac
event detection by the cardiosaver 5 of FIGS. 1-4. The heart signal
processing program 450 is an example of one of many such detection
programs whose instructions could reside in the program memory 45
for use by the CPU 44 of the cardiosaver 5 as shown in FIG. 4. The
main section of the heart signal processing program 450 begins with
step 451 where the event counter "k" is set to zero indicating
there have been no detected events. Next, in step 452 the
cardiosaver 5 is said to sleep for X seconds. The term sleep here
indicates that for a period of X seconds, the cardiosaver 5 would
either be placed in a low power standby mode (if available) or
would otherwise simply wait for a time of X seconds before moving
to step 453. Step 453 following 452 has an electrogram segment
representing Y seconds of electrogram data captured into the FIFO
buffer 42 of FIG. 4. .sigma. a is the data sampling rate in samples
per second, thus the total number of samples collected in step 453
is .sigma. multiplied by Y. It is envisioned that X would be a time
between 5 seconds and 5 minutes with 20 seconds as a preferred
value. Y would be between 3 and 30 seconds with 10 seconds as a
preferred value. .sigma. is typically between 100 and 500 samples
per second with 200 samples per second being a preferred value.
[0159] After being captured, in step 454, the Y seconds of
electrogram data representing the most recent electrogram segment
is transferred to the recent electrogram memory 472 of FIG. 4. At
this time the processing and analysis of the data begins.
Throughout the remainder of this detailed description of the
drawings, the "Y second long electrogram segment" refers to the
most recently collected Y seconds of electrogram data that have
been captured and transferred to the recent electrogram memory 472
by the steps 453 and 454. The term "recent electrogram segments"
refers to all of the electrogram segments stored in the recent
electrogram memory 472. For example, there could be eight total 10
second long recent electrogram segments that were captured at 30
second intervals over a 4 minute period.
[0160] The first processing step following the collection of the Y
second long electrogram segment is step 455 that measures the
intervals between the R waves in the most Y second long electrogram
segment. These R-R intervals are then used to calculate the average
heart rate and R-R interval variation for the Y second long
electrogram segment. If the average heart rate is below a
programmed low heart rate limit .rho..sub.low or above a programmed
high heart rate limit .rho..sub.high, it is considered
"out-of-range" and a Hi/Low heart rate subroutine 420 (see FIG. 9)
is run to properly respond to the condition.
[0161] If the R-R interval variation within the Y second long
electrogram segment is more than a programmed limit, the hi/low
heart rate subroutine is also run. This is an important feature of
the present invention as PVC's and unstable heart rhythms such as a
bigeminal rhythm can cause errors in an ST shift detection
algorithm that is works best with a steady heart rhythm. One
embodiment of the present invention identifies an unsteady heart
rate by comparing the two shortest R-R intervals and the 2 longest
intervals in the Y second long electrogram segment. If the
difference between both of the two shortest R-R intervals and the
average of the two longest R-R intervals are more than a programmed
percentage .alpha., an unsteady heart rate is identified. For
example the programmed percentage .alpha. might be 25% so that if
the two shortest R-R intervals are each more than 25% less than the
average of the two longest R-R intervals, then the heart rate is
unsteady. It is envisioned that if longer times Y are used for
electrogram segment collection then it might require 3 or more
"short" beats to indicated an unsteady heart rate. Any beat that is
not too short is classified by step 455 as a normal beat.
.rho..sub.low, .rho..sub.high and a are programmable parameters
typically set using the programmer 68 during programming of the
cardiosaver 5. Typical values for .rho..sub.low and .rho..sub.high
would be 50 and 140 beats per minute respectively.
[0162] If the heart rate is not high, low or unsteady as checked in
step 455, the heart signal processing program 450 moves to step 456
where the average heart rate is compared to a programmed normal
range between .rho..sub.low and .rho..sub.elevated where
.rho..sub.elevated is the elevated heart rate limit that defines
the upper limit of the "normal range" (e.g. 80 beats per minute).
If the patient's heart rate is elevated but not out-of-range (i.e.
above .rho..sub.high), the patient may be exercising and the
ischemia subroutine 480 allows for different cardiac event
detection criteria during elevated heart rates to reduce false
positive detections of acute myocardial infarction and to detect
exercise induced ischemia. An example of one embodiment of the
ischemia subroutine 480 is illustrated in FIG. 10.
[0163] Although the above specification describes low, high and
elevated heart rate limits .rho..sub.low, .rho..sub.high and
.rho..sub.elevated, it is envisioned that instead of heart rate
(i.e. beats per second) the limits and decision making could be set
in terms or R wave to R wave (R-R) interval with the low, high and
elevated limits are for R-R interval and are expressed in seconds
per beat, milliseconds per beat or samples per beat.
[0164] If the average heart rate of the patient is within the
"normal" range in step 456, then the program 450 moves to step 457
where it looks for an excessive ST shift on M out of N beats as
compared with the baseline electrogram segment collected at a time
U.+-.W minutes in the past. U can be any time from 1 minute to 48
hours but to allow for daily cycles U=24 hours is a preferred
embodiment. W is half the interval between times when the baseline
data is saved and can be any time from 10 seconds to 12 hours. For
a U of 24 hours, a preferred setting would have W equal to half an
hour so that the current Y second long electrogram segment is
always being compared with a baseline electrogram segment from
24.+-.1/2 hour before. This also means that baseline electrogram
segments are saved and processed to extract detection parameters at
an interval of twice W (2W). I.e., if W is half an hour, then the
baseline data is saved and processed once an hour. M can be any
number from 1 to 30 and N can be any number from M to 100. An
example of a typical M and N used would be 6 out of 8 beats. It is
envisioned that the first of the 8 beats will typically be the beat
including the 2.sup.nd R wave in the Y second long electrogram
segment collected in steps 453 and 454.
[0165] If one is trying to detect abnormalities in 6 out of 8 beats
for a positive detection, a negative detection will occur whenever
3 OK beats without a detected abnormality are found (so long as it
is before the 6 "abnormal" beats with detected abnormalities). To
save processing time and potentially extend battery life it is
desirable to have steps 457 and 469 of FIG. 5 simultaneously count
both the number of OK beats and the number of abnormal beats. The
steps 457 and 469 will stop processing beats when either 3 OK beats
(a negative detection) or 6 abnormal beats (a positive detection)
are found. Another advantage of this technique is that even if the
Y second long electrogram segments collected in steps 453 and 465
have less than 6 beats but there are at least 3 OK beats, there
sufficient data to declare a negative detection (i.e. nothing is
wrong). As heart attacks occur rarely, this improvement will
greatly enhance the efficiency of detection algorithm. Although the
example above uses 3 OK vs. 6 out of 8 abnormal beats, this
technique will work for any M out of N detection scheme where N-M+1
OK beats is sufficient to declare that no event has occurred. This
enhancement will work in any device for detecting cardiac events
whether implanted within the patient or external to the patient.
This technique both looking for OK and abnormal beats can be
applied throughout the subroutines of the present invention. For
example, ST shift is detected in steps 434 and 439 of FIG. 9 and is
of particular importance with a low heart rate where there may not
be M beats to process in the Y seconds. It is also applicable to
the Unsteady Heart Rate Subroutine 410 in step 418 and can reduce
the number of times that an additional Y second electrogram segment
must be collected to get sufficient data to detect the presence or
absence of an event.
[0166] The electrogram segment length Y should be programmed to be
of sufficient length such that there will be more than N beats
within the Y second electrogram segment for heart rates at the low
limit for the normal heart rate range. If Y is too short, then the
programs 450 and 460 may need to also allow for the collection of
additional electrogram data as shown in FIG. 12 for the unsteady
heart rate subroutine 410.
[0167] An alternate to ST shift detection in step 457 is to process
just the T wave, which can change its peak or average amplitude
rapidly if there is a heart attack. The T wave can, however change
its amplitude slowly under normal conditions so a T wave shift
detector would need a much shorter time U than that of a detector
using the ST segment before the T wave. If the detector is checking
for such T wave shift, i.e. a voltage shift of the T wave part of
the ST segment, then it may be desirable to check against a
baseline where U is 1 to 30 minutes and W is 15 seconds to 15
minutes. For example, U=3 minutes and W=15 seconds is a preferred
setting to catch a quickly changing T wave. This would also allow
use of recent electrogram segments stored in the recent electrogram
memory of FIG. 4 as baseline electrogram segments for T wave shift
detection. It is envisioned that the programmer 68 of FIG. 1 would
allow the patient's doctor to program the cardiosaver 5 to use ST
segment shift or T wave shift detectors by themselves, or together
simultaneously. If both were used then the programmer 68 would
allow the patient's doctor to choose whether a positive detection
will result if either technique detects an event or only if both
detect an event.
[0168] If the average heart rate is in the normal range, is not
unsteady and there is no cardiac event detection in step 457, (i.e.
the electrogram signal is indicative of a "normal" heart signal for
the patient), the heart signal processing program 450 checks in
step 458 if it is more than the interval of 2W minutes since the
last time baseline data was captured. If it has been more than 2W,
the baseline parameter extraction subroutine 440 of FIG. 7 is
run.
[0169] The parameters X, Y, U and W are stored with the
programmable parameters 471 in the RAM 47 in FIG. 4. These
parameters may be permanently set at the time of manufacturing of
the cardiosaver 5 or they may be programmed through the programmer
68 of FIG. 1. The calculated criteria for cardiac event detection
extracted from the baseline electrogram segments stored in baseline
electrogram memory 474 are stored in the calculated baseline data
memory 475 of the RAM 47.
[0170] A typical configuration of the heart signal processing
program 450 using only an ST shift detector, would use a sleep of
X=20 seconds, followed by collection of a Y=10 second long
electrogram segment. If the patient's heart rate is in a normal
range of between 50 and 80 beats per minute, step 457 would check
for an excessive shift of the ST segment in 6 out of 8 of the beats
as compared with baseline data collected 24.+-.1/2 hour
previously.
[0171] If there has been a detected excessive ST shift in M out of
N beats in step 457, the ST Verification Subroutine 460 is run to
be sure that the detected event is not a transitory change in the
electrogram.
[0172] The ST Verification Subroutine 460 begins with step 461
where the recently collected Y second long electrogram segment is
saved to the event memory 476 of FIG. 4 for later review by the
patient's doctor.
[0173] The ST shift verification subroutine 460 then increments the
event counter k by 1 (step 462) and then checks (step 463) if k is
equal to 3 (i.e. 3 events is the trigger for an alarm. If k=3 then
the alarm subroutine 490 illustrated in FIG. 8 is run, thus
declaring that there has been a positive detection of a major
cardiac event. FIG. 11 illustrates examples of the combinations of
conditions that can lead to k=3 and the running of the alarm
subroutine 490.
[0174] Although step 463 is shown checking if k=3 as the condition
for running the alarm subroutine 490, the number of events required
could be a programmable parameter from k=1 to k=20. Even higher
possible values than k=20 might be used to avoid false positive
detections. With current average times from onset of a heart attack
to arrival at a treatment center of 3 hours, a few minutes delay
for a device that should enable the patient to easily reach a
treatment center within 30 minutes is valuable if it improves the
reliability of detection.
[0175] In step 463 if k is less than 3 then the ST shift
verification subroutine 460 proceeds to sleep Z seconds in step 464
followed by collection (step 465) and saving (step 466) to the next
location in the recent electrogram memory 472 of FIG. 4 of a new Y
second long electrogram segment. Z seconds can be different from
the X seconds used in step 452 to allow the ST shift verification
subroutine 460 to look over longer (or shorter) intervals than the
main program so as to best verify the positive detection of step
457. The term sleep here has the same connotation as in step 452. A
preferred embodiment of the present invention uses Z=X=20
seconds.
[0176] The ST shift verification subroutine 460 then checks for
heart rate out-of-range or unsteady in step 467. As described with
respect to step 455 above, heart rate out-of-range means that the
average heart rate in the Y second long electrogram segment is
below the low heart rate limit .rho..sub.low or above the high
heart rate limit .rho..sub.high.
[0177] If the heart rate is out-of range or unsteady step 467 will
initiate the Hi/Low subroutine 420. If the heart rate is not out-of
range or unsteady, then step 468 follows to check if the heart rate
is normal or elevated similar to step 456 above. If the heart rate
is elevated, the ischemia subroutine 480 is run. The reason for
checking if the heart rate has changed is that acute myocardial
infarction can induce high heart rates from tachycardia or
fibrillation that might mask the ST shift but are in of themselves
major cardiac events whose detection will increment the event
counter k.
[0178] If the heart rate is in the normal range (i.e. not
elevated), then step 469 checks for an excessive ST and/or T wave
shift in M out of N beats of the Y second long electrogram segment
as compared with the baseline data extracted U.+-.W minutes in the
past (similar to step 457). If no excessive ST and/or T wave shift
is seen, the subroutine 460 returns to step 458 of the heart signal
processing program 450 and then eventually back to step 451, the
start of heart signal processing program 450. In step 451, k is set
back to 0 so that only if there are cardiac events detected in
three (k) successive Y second long electrogram segments, will the
alarm subroutine 490 be run. In a preferred embodiment of the
present invention, steps 457 and 469 only examine M out of N
"normal" beats, ignoring any beats that are too short as determined
by step 455.
[0179] It is important to note, that baseline data is extracted
only when the heart rate is within the normal range and there is
not an excessive ST or T wave shift in M out of N beats. In one
embodiment of the present invention, this is improved further by
having the baseline parameter extraction subroutine 440 only
process normal beats that individually do not exhibit an excessive
ST and/or T wave shift.
[0180] FIG. 6 illustrates the features of a single normal beat 500
of an electrogram segment and a single beat 500' of an AMI
electrogram segment that has a significant ST segment shift as
compared with the normal beat 500. Such ST segment shifting occurs
within minutes following the occlusion of a coronary artery during
an AMI. The beats 500 and 500' show typical heart beat wave
elements labeled P, Q, R, S, and T. The definition of a beat such
as the beat 500 is a sub-segment of an electrogram segment
containing exactly one R wave and including the P and Q elements
before the R wave and the S and T elements following the R
wave.
[0181] For the purposes of detection algorithms, different
sub-segments, elements and calculated values related to the beats
500 and 500' are hereby specified. The peak of the R wave of the
beat 500 occurs at the time T.sub.R (509). The PQ segment 501 and
ST segment 505 are sub-segments of the normal beat 500 and are
located in time with respect to the time T.sub.R (509) as
follows:
[0182] a. The PQ segment 501 has a time duration D.sub.PQ (506) and
starts T.sub.PQ (502) milliseconds before the time T.sub.R
(509).
[0183] b. The ST segment 505 has a time duration D.sub.ST (508) and
starts T.sub.ST (502) milliseconds after the time T.sub.R
(509).
[0184] The PQ segment 501' and ST segment 505' are sub-segments of
the beat 500' and are located in time with respect to the time
T'.sub.R (509') as follows:
[0185] c. The PQ segment 501' has a time duration D.sub.PQ (506)
and starts T.sub.PQ (502) milliseconds before the time T'.sub.R
(509').
[0186] d. The ST segment 505' has a time duration D.sub.ST (508)
and starts T.sub.ST (502) milliseconds after the time T'.sub.R
(509').
[0187] The ST segments 505 and 505' and the PQ segments 501 and
501' are examples of sub-segments of the electrical signals from a
patient's heart. The R wave and T wave are also sub-segments. The
dashed lines V.sub.PQ (512) and V.sub.ST (514) illustrate the
average voltage amplitudes of the PQ and ST segments 501 and 505
respectively for the normal beat 500. Similarly the dashed lines
V'.sub.PQ (512') and V'.sub.ST (514') illustrate the average
amplitudes of the PQ and ST segments 501' and 505' respectively for
the beat 500'. The "ST deviation".DELTA.V (510) of the normal beat
500 and the ST deviation .DELTA.V.sub.AMI (510') of the AMI
electrogram beat 500' are defined as:
.DELTA.V(510)=V.sub.ST(514)-V.sub.PQ(512)
.DELTA.V.sub.AMI(510')=V'.sub.ST(514')-V'.sub.PQ(512')
[0188] Note that the both beats 500 and 500' are analyzed using the
same time offsets T.sub.PQ and T.sub.ST from the peak of the R wave
and the same durations D.sub.PQ and D.sub.ST. In this example, the
beats 500 and 500' are of the same time duration (i.e. the same
heart rate). The parameters T.sub.PQ, T.sub.ST, D.sub.PQ and
D.sub.ST would typically be set with the programmer 68 of FIG. 1 by
the patient's doctor at the time the cardiosaver 5 is implanted so
as to best match the morphology of the patient's electrogram signal
and normal heart rate. V.sub.PQ (512), V.sub.ST (514), V.sub.R
(503) and .DELTA.V (510) are examples of per-beat heart signal
parameters for the beat 500.
[0189] Although it may be effective to fix the values of time
offsets T.sub.PQ (502) and T.sub.ST (504) and the durations
D.sub.PQ (506) and D.sub.ST (508), it is envisioned that the time
offsets T.sub.PQ and T.sub.ST and the durations D.sub.PQ and
D.sub.ST could be automatically adjusted by the cardiosaver 5 to
account for changes in the patient's heart rate. If the heart rate
increases or decreases, as compared with the patient's normal heart
rate, it envisioned that the offsets T.sub.PQ (502) and T.sub.ST
(504) and/or the durations D.sub.PQ (506) and D.sub.ST (508) could
vary depending upon the R-R interval between beats or the average
R-R interval for an electrogram segment. A simple technique for
doing this would vary the offsets T.sub.PQ and T.sub.ST and the
durations D.sub.PQ and D.sub.ST in proportion to the change in R-R
interval. For example if the patient's normal heart rate is 60
beats per minute, the R-R interval is 1 second; at 80 beats per
minute the R-R interval is 0.75 seconds, a 25% decrease. This could
automatically produce a 25% decrease in the values of T.sub.PQ,
T.sub.ST, D.sub.PQ and D.sub.ST. Alternately, the values for
T.sub.PQ, T.sub.ST, D.sub.PQ and D.sub.ST could be fixed for each
of up to 20 preset heart rate ranges. In either case, it is
envisioned that after the device has been implanted, the patient's
physician would, through the programmer 68 of FIG. 1, download from
the cardiosaver 5 to the programmer 68, a recent electrogram
segment from the recent electrogram memory 472. The physician would
then use the programmer 68 to select the values of T.sub.PQ,
T.sub.ST, D.sub.PQ and D.sub.ST for the heart rate in the
downloaded recent electrogram segment. The programmer 68 would then
allow the physician to choose to either manually specify the values
of T.sub.PQ, T.sub.ST, D.sub.PQ and D.sub.ST for each heart rate
range or have the cardiosaver 5 automatically adjust the values of
T.sub.PQ, T.sub.ST, D.sub.PQ and D.sub.ST based on the R-R interval
for each beat of any electrogram segment collected in the future by
the cardiosaver 5. It is also envisioned that only the offset
times, T.sub.PQ and T.sub.ST, might be automatically adjusted and
the durations D.sub.PQ and D.sub.ST would be fixed so that the
average values of the ST and PQ segments V.sub.PQ (512), V.sub.ST
(514), V'.sub.PQ (512') and V'.sub.ST (514') would always use the
same number of data samples for averaging.
[0190] While the simplest method of adjusting the times T.sub.PQ
and T.sub.ST is to adjust them in proportion to the R-R interval
from the preceding R wave to the R wave of the current beat, a
preferred embodiment of the present invention is to adjust the
times T.sub.PQ and T.sub.ST in proportion to the square root of the
R-R interval from the preceding R wave to the R wave of the current
beat. It is also envisioned that a combination of linear and square
root techniques could be used where T.sub.ST and D.sub.ST are
proportional to the square root of the R-R interval while T.sub.PQ
and D.sub.PQ are linearly proportional to the R-R interval.
[0191] When used in pacemakers or combination pacemaker/ICDs it
envisioned that the start time T.sub.ST and duration D.sub.ST of
the ST segment may have different values than during sinus rhythm
(when the pacemaker is not pacing) as pacing the heart changes the
characteristics of ischemic ST shifts causing them to occur later
relative to the start of the R wave. It is also envisioned, that
the offset for the start of the ST segment may be better measured
from the S Wave instead of the R wave used for sinus rhythm when
the pacemaker is not pacing. The technique of using different
timing parameters for start and duration when pacing can be applied
to analysis of any sub-segment of the electrogram including the
sub-segment that includes the T wave peak.
[0192] Various techniques have been used to detect the R and S
waves in electrogram data. A well known technique is to look for a
change in slope that exceeds a programmed threshold. Because the
polarity of the wave depends on electrode placement in surface ECG,
the slope threshold is the same for both positive and negative
slopes. Because the guardian system has the polarity in a right
ventricle to implanted device fixed, the present invention
envisions using different threshold values for positive and
negative slopes to better detect paced beats and/or PVCs.
[0193] The detection algorithm may need to differentiate between R,
S and T waves so as not to miscalculate the R-R interval between
beats. This can be accomplished by measurement of the width of each
of the R, S, and T waves where the R and S are always much narrower
than the T wave. It is envisioned that the present invention would
discriminate R (or S) vs. T wave by the width of the wave. For
example, to be a detected R wave, the wave must have a width that
is within a specified range of the R waves that were measured
within a pre-set time such as a minute in the past. In this way if
the T wave spikes up during an ischemic event it will be too wide
to be considered an R wave and the detection algorithm will not be
fooled.
[0194] Another way to accomplish the same result is to use a
separate high pass filter for the signal used for R wave detection
where the R wave detector high pass filter cuts has more low
frequency attenuation than the high pass filter used for the signal
analyzed for ST segment changes. This technique is currently used
in pacemakers and ICDs for R wave detection but can also be applied
to a stand alone cardiosaver device for ischemia detection. Typical
high pass filter settings would be as follows:
[0195] For R wave detection use a high pass filter with 6 dB
attenuation at 10 Hz to 20 Hz.
[0196] For ST segment shift detection use a high pass filter with 6
dB attenuation at 0.1 to 0.5 Hz.
[0197] An example of a sequence of steps used to calculate the ST
deviation 510 for the normal beat 500 are as follows:
[0198] 1. Identify the time T.sub.R (509) for the peak of the R
wave for the beat 500,
[0199] 2. Calculate the time since the previous R wave and use that
time to look up or calculate the values of T.sub.PQ, T.sub.ST,
D.sub.PQ and D.sub.ST.
[0200] 3. Average the amplitude of the PQ segment 501 between the
times (T.sub.R-T.sub.PQ) and (T.sub.R-T.sub.PQ+D.sub.PQ) to create
the PQ segment average amplitude V.sub.PQ (512),
[0201] 4. Average the amplitude of the ST segment 505 between the
times (T.sub.R+T.sub.ST) and (T.sub.R+T.sub.ST+D.sub.ST) to create
the ST segment average amplitude V.sub.ST (514),
[0202] 5. Subtract V.sub.PQ (512) from V.sub.ST (514) to produce
the ST deviation .DELTA.V (510) for the beat 500.
[0203] Although only one normal beat 500 is shown here, there would
typically be multiple beats saved in the Y second long electrogram
segments stored in the recent electrogram memory 472 and the
baseline electrogram memory 474 of FIG. 4. At preset time intervals
during the day step 458 of FIG. 5 will run the baseline parameter
extraction subroutine 440 that will calculate the "average baseline
ST deviation" .DELTA.V.sub.BASE defined as the average of the ST
deviations .DELTA.V (510) for at least two beats of a baseline
electrogram segment. Typically the ST deviation of 4 to 8 beats of
the baseline electrogram segment will be averaged to produce the
average baseline ST deviation .DELTA.V.sub.BASE.
[0204] For each of "i" preset times during the day (at a time
interval of approximately 2W) an average baseline ST deviation
.DELTA.V.sub.BASE(i) will be calculated and saved in the calculated
baseline data memory 475 for later comparison with the ST deviation
.DELTA.V (510) of each beat of a recently collected electrogram.
For example, in a preferred embodiment of the present invention,
the average baseline ST deviation .DELTA.V.sub.BASE(i) is collected
once an hour and there are be 24 values of .DELTA.V.sub.BASE(i)
CDELTA.V.sub.BASE(1), .DELTA.V.sub.BASE(2) . . . .
DELTA.V.sub.BASE(24)) stored in the calculated baseline data memory
475 of FIG. 4. An excessive ST shift for a single beat of a
recently collected electrogram segment is then detected when the ST
deviation .DELTA.V for that beat shifts by more than a
predetermined threshold amplitude from the average baseline ST
deviation .DELTA.V.sub.BASE(i) collected approximately 24 hours
before.
[0205] The ST shift of a given beat is calculated by subtracting
the appropriate averaged baseline ST deviation .DELTA.V.sub.BASE(i)
from the ST deviation .DELTA.V for that beat. Assuming the R-R
interval indicates that the heart rate for a beat is in the normal
range then an excessive ST shift for a single beat is detected if
(.DELTA.V-.DELTA.V.sub.BASE(i)) is greater than the normal ST shift
threshold H.sub.normal for the normal heart rate range. The heart
signal processing program 450 of FIG. 5 requires that such an
excessive ST shift be positively identified in M out of N beats in
three successive recent electrogram segments before the alarm
subroutine 490 is activated. The threshold H.sub.normal may be a
fixed value that does not change over time and is set at the time
of programming of the cardiosaver 5 with the programmer 68 of FIG.
1.
[0206] In a preferred embodiment, the threshold for detection of
excessive ST shift is not fixed but is calculated as H.sub.ST(i)
from the i'th baseline electrogram segment stored in the baseline
electrogram memory 474 of FIG. 4. To do this the difference between
the amplitude of the peak of the R wave V.sub.R (503) and the
average PQ segment amplitude V.sub.PQ (512) are calculated for each
of at least 2 beats of each baseline electrogram segment by the
baseline parameter extraction subroutine 440. The average value
AR(i) of this difference (V.sub.R-V.sub.PQ) for at least two beats
of the i'th baseline electrogram segment can be used to produce a
threshold for ST shift detection H.sub.ST(i) that is proportional
to the signal strength of the i'th baseline electrogram segment.
The advantage of this technique is that, if the signal strength of
the electrogram changes slowly over time, the threshold H.sub.ST(i)
for excessive ST shift detection will change in proportion.
[0207] The preferred embodiment of the present invention would have
a preset percentage P.sub.ST that is multiplied by .DELTA.R(i) to
obtain the threshold H.sub.ST(i)=P.sub.ST.times..DELTA..sub.R(i).
Thus, the threshold H.sub.ST(i) would be a fixed percentage of the
average height of the R wave peaks over the ST segments of the i'th
baseline electrogram segment. For example, if P.sub.ST is 25% an
excessive ST shift on a given beat would be detected if the ST
shift (.DELTA.V-.DELTA.V.sub.BASE(i)) is greater than the threshold
H.sub.ST(i) where H.sub.ST(i) is 25% of the average PQ to R height
.DELTA.R(i) of the i'th baseline electrogram segment.
[0208] In a preferred embodiment of the present invention heart
signal processing program 450 of FIG. 5, the value X and Z are both
20 seconds, Y is 10 seconds, 2W is 60 minutes, U is 24 hours, W is
30 minutes, M is 6 and N is 8. Therefore the steps 457 and 469 of
FIG. 5 will check for excessive ST shifts in 6 out of 8 beats from
of the Y=10 second long electrogram segment captured every 30
seconds as compared with parameters extracted from the baseline
electrogram segment captured 24.+-.1/2 hour before. In this
preferred embodiment baseline electrogram segments are captured
once per hour.
[0209] It is also envisioned that the patient would undergo a
stress test following implant. The electrogram data collected by
the implant 5 would be transmitted to the programmer 68 of FIG. 1,
and one or more of the parameters T.sub.PQ (502), T.sub.ST (504),
D.sub.PQ (506) and D.sub.ST (508) of FIG. 6 would be automatically
selected by the Programmer based on the electrogram data from the
stress test. The data from the stress test should cover multiple
heart rate ranges and would also be used by the programmer 68 to
generate the excessive ST shift detection percentage thresholds
P.sub.ST for each of the heart rate ranges. In each case where the
programmer 68 automatically selects parameters for the ST shift
detection algorithm, a manual override would also be available to
the medical practitioner. Such an override is of particular
importance as it allows adjustment of the algorithm parameters to
compensate for missed events or false positive detections.
[0210] The S wave peak voltage V.sub.S (507) is also shown on the
baseline beat 500 in FIG. 6. While the preferred embodiment of the
present invention uses the average PQ to R wave amplitude
.DELTA.R(i) as the normalization voltage for setting the threshold
H.sub.ST(i), it is also envisioned that normalization voltage could
be the average of the entire R wave to S wave amplitude
(V.sub.R-V.sub.S) or it could be the larger of .DELTA.R(i) or the
PQ to S amplitude .DELTA.S(i)=V.sub.S-V.sub.PQ. It is important to
note here that the threshold H.sub.ST(i) is set as a percentage of
the baseline average signal amplitude. This is important because
the baseline signal is only collected if the electrogram is normal
and therefore the thresholds would not be affected by transient
changes in signal amplitude (e.g. R wave height) that can occur
during an ST elevation myocardial infarction. Therefore, for the
purposes of the present invention the threshold H.sub.ST(i) is
calculated as a percentage of the average signal amplitude of at
least two beats of the baseline electrogram segment where the
average signal amplitude of the baseline segment can be any of the
following:
[0211] the average PQ segment to R voltage difference
.DELTA.R(i),
[0212] the peak-to-peak voltage of the beat (i.e. the R to S wave
voltage difference) (V.sub.R-V.sub.S),
[0213] the average PQ segment to S wave voltage difference
.DELTA.S(i),
[0214] the larger of .DELTA.R(i) or .DELTA.S(i), or
[0215] any average signal amplitude calculated from at least two
beats of the baseline electrogram segment.
[0216] FIG. 7 illustrates a preferred embodiment of the baseline
extraction subroutine 440. The subroutine 440 begins in step 439 by
saving in the i'th memory location in baseline electrogram memory
474 of FIG. 4, the last Y second long electrogram segment saved
into the "Recent" electrogram memory in step 454 of FIG. 5. This Y
seconds of electrogram data then becomes the baseline electrogram
segment for calculating parameters for detection to be used during
the 2 W long period of time U.+-.W minutes in the future.
[0217] Next in step 441 the baseline extraction subroutine 440
finds the R wave peak times T.sub.R(j) for the 1.sup.st through
(N+2).sup.th beat (j=1 through N+2) in the baseline electrogram
segment saved in step 439. This is a total of N+2 beats. Each time
T.sub.R(j) is typically counted from the beginning of the Y second
long electrogram segment until the peak of the j'th R wave.
[0218] Next in step 442 the average R-R interval of the i'th
baseline electrogram segment RR(i) is calculated by averaging the
R-R intervals for each of the N+1 beats (j=2 through N+2) where the
R-R interval for beat j is T.sub.R(j)-T.sub.R(j-1). For example,
for beat 2, the R-R interval is the time interval from the R wave
peak of beat 1 (the very first R wave) to the R wave peak of beat
2. I.e. R-R intervals before and after each of the N beats j=2
through j=N+1 are calculated. This step also identifies any R-R
intervals that are out of the "normal" range as defined in the
programming of the cardiosaver 5. In a preferred embodiment of the
present invention, baseline data will only be extracted from
"normal" beats. A normal beat is one in which the R-R interval both
before and after the R wave is in the "normal range. This is a
preferred technique to use as a too short R-R interval before the R
wave can affect the PQ segment amplitude and a too short R-R
interval after the R wave can affect the ST segment amplitude,
either of which could produce a false indication of excessive ST
shift.
[0219] Next in step 443 the offsets T.sub.PQ, T.sub.ST, D.sub.PQ
and D.sub.ST (see FIG. 6) are calculated. In one embodiment,
T.sub.PQ and T.sub.ST are the percentages .phi..sub.PQ and
.phi..sub.ST multiplied by the average R-R interval RR(i)
respectively. This technique will adjust the location of the start
of the PQ and ST segments to account for changes in heart rate. The
percentages .phi..sub.PQ and .phi..sub.ST would be selected by the
patient's doctor based on "normal" electrogram segments analyzed by
the programmer 68 of FIG. 1. Another embodiment of the present
invention uses fixed time offsets T.sub.PQ and T.sub.ST that are
programmed by the patient's doctor. Similarly the duration of the
PQ and ST segments D.sub.PQ and D.sub.ST (see FIG. 6) can be
calculated by multiplying the percentages .delta..sub.PQ and
.delta..sub.ST times the average R-R interval RR(i) respectively.
The percentages .delta..sub.PQ and .delta..sub.ST would also be
selected by the patient's doctor using the programmer 68. The
preferred embodiment of the present invention uses fixed segment
durations D.sub.PQ and D.sub.ST that are programmed by the
patient's doctor. Using fixed durations D.sub.PQ and D.sub.ST has
the advantage of keeping the same number of samples averaged in
each calculation of the average PQ and ST segment amplitudes
V.sub.PQ and V.sub.ST respectively.
[0220] Next in step 444 for each of the N beats (j=2 through N+1)
identified by step 422 as a normal beat, V.sub.PQ(j) the average of
the PQ segment amplitude of the j'th beat over the duration
D.sub.PQ beginning T.sub.PQ before the peak T.sub.R(j) and
V.sub.ST(j) the average ST segment amplitude of the j'th beat over
the duration D.sub.ST beginning T.sub.ST after the time T.sub.R(j)
are calculated. Similarly, step 444 calculates the peak T wave
heights V.sub.T(j).
[0221] For each beat the ST deviation .DELTA.V.sub.ST(j) that is
the difference between V.sub.ST(j) and V.sub.PQ(j) is then
calculated in step 445. Similarly, step 445 calculates the T wave
deviation .DELTA.V.sub.T(j) that is the difference between
V.sub.T(j) and V.sub.PQ(j). It should be noted that step 455 of
FIG. 5 will only allow the baseline extraction subroutine to be run
if less than 2 too short beats are present, thus at least N-2 of
the N beats used for baseline data extraction will be normal beats.
Although there is a limit here of less than 2 short beats, it is
envisioned that other minimum numbers of short beats than 2 might
also be used.
[0222] Next in step 446 the ST deviation .DELTA.V.sub.ST(j) for all
normal beats within the N beats is averaged to produce the i'th
average baseline ST deviation .DELTA.V.sub.BASE(i). Similarly, in
step 446 the T wave deviation .DELTA.V.sub.T(j) for all normal
beats within the N beats is averaged to produce the i'th average
baseline T wave deviation .DELTA.T.sub.BASE(i).
[0223] An alternate embodiment of the present invention would also
check for excessive ST shift on each normal beat and exclude any
such beats from the average baseline ST deviation and T wave
deviation calculations.
[0224] Next in step 447, .DELTA.R(i) the average of the height of
the peak of the j'th R wave above the average PQ segment
V.sub.PQ(j) is calculated for the normal beats. .DELTA.R(i) acts as
an indication of the average signal strength of the i'th baseline
electrogram segment. .DELTA.R(i) is used to provide a detection
threshold for excessive ST shift that will adapt to slow changes in
electrogram signal strength over time. This is of most value
following implant as the sensitivity of the electrodes 14 and 17
may change as the implant site heals.
[0225] .DELTA.T.sub.BASE (i) can either be the average of the
signal samples of the entire T waves or it can be the average of
the peak amplitude of the T waves in the normal beats. It is also
envisioned, that if both ST and T wave shift detection are used, a
cardiac event could be declared if either excessive ST shift or T
wave shift detects a change (this is preferred) or the program
could require that both excessive ST shift and T wave shift be
present.
[0226] Next in step 448, the threshold for ST shift detection for
normal heart rates H.sub.ST(i) is calculated by multiplying the
programmed threshold percentage P.sub.ST of .DELTA.R(i). Also in
step 448, if the T wave shift detector is being used, the threshold
for T wave shift detection for normal heart rates H.sub.T(i) is
calculated by multiplying the programmed threshold percentage
P.sub.T of .DELTA.R(i).
[0227] Finally in step 449, the extracted baseline parameters
.DELTA.V.sub.BASE(i), .DELTA.T.sub.BASE(i), .DELTA.R(i),
H.sub.ST(i) and H.sub.T(i) are saved to the calculated baseline
data memory 475. The baseline extraction subroutine 440 has ended
and the program returns to the main heart signal processing program
450 step 451 of FIG. 5.
[0228] One embodiment of ST shift and T wave shift detection might
use a baseline for ST shift detection that is 24.+-.1/2 hour before
and a baseline for T wave shift that is 1 to 4 minutes in the past.
This would require that the baseline extraction subroutine 440 be
run for T wave shift parameters approximately every 60 seconds and
for ST segment parameters every hour.
[0229] Although the baseline extraction subroutine 440 is described
here as using the same "N" as the number of beats processed as the
ST shift detection steps 457 and 469 of FIG. 5, it is envisioned
that either a greater or lesser number of beats could be used for
baseline extraction as compared with the number of beats "N"
checked for excessive ST shifts in FIG. 5.
[0230] Typical values used for the baseline extraction subroutine
440 as shown in FIG. 7 would be N=8 to average the data over 8
beats using beats 2 through 9 of the Y second long electrogram
segment. However, it is envisioned that as few as 1 beat or as many
as 100 beats or higher could be used to calculate the parameters
extracted by subroutine 440. Also even though the preferred
embodiment of the present invention extracts baseline data only
from "normal" beats, it is envisioned that using all 8 beats would
usually yield an acceptable result.
[0231] Although the baseline extraction subroutine 440 shows the
extraction of parameters for identifying excessive ST shifts and T
wave shifts, the cardiosaver 5 would function with either of these
detection methods or could use other techniques to measure the
changes in electrogram signals indicating one or more coronary
event.
[0232] FIG. 8 illustrates a preferred embodiment of the alarm
subroutine 490. The alarm subroutine 490 is run when there have
been a sufficient number of events detected to warrant a major
event cardiac alarm to the patient. The alarm subroutine 490 begins
with step 491 where the entire contents of both baseline
electrogram memory 474 and recent electrogram memory 472 of FIG. 4
are saved into the event memory 476. This saves the above mentioned
electrogram data in a place where it is not overwritten by new
baseline or recent electrogram data to allow the patient's
physician to review the electrogram segments collected during a
period of time that occurred before the alarm. In a preferred
embodiment with 24 baseline electrogram segments collected once per
hour, and 8 recent electrogram segments collected every 30 seconds,
the physician will be able to review a significant amount of
electrogram data from the 4 minutes just before the cardiac event
as well as being able to see any changes in the 24 hours before the
event.
[0233] Next; in step 492 the internal alarm signal is turned on by
having the CPU 44 of FIG. 4 cause the alarm sub-system 48 to
activate a major event alarm signal.
[0234] Next in step 493 the alarm subroutine instructs the CPU 44
to send a major event alarm message to the external alarm system 60
of FIG. 1 through the telemetry sub-system 46 and antenna 35 of the
cardiosaver 5 of FIG. 4. The alarm message is sent once every L1
seconds for L2 minutes. During this time step 494 waits for an
acknowledgement that the external alarm has received the alarm
message. After L2 minutes, if no acknowledgement is received, the
cardiosaver 5 of FIG. 1 gives up trying to contact the external
alarm system 60. If an acknowledgement is received before L2
minutes, step 495 transmits alarm related data to the external
alarm system. This alarm related data would typically include the
cause of the. alarm, baseline and last event electrogram segments
and the time at which the cardiac event was detected.
[0235] Next in step 496, the cardiosaver 5 transmits to the
external alarm system 60 of FIG. 1 other data selected by the
patient's physician using the programmer 69 during programming of
the cardiosaver. These data may include the detection thresholds
H.sub.ST(i), H.sub.T(i) and other parameters and electrogram
segments stored in the cardiosaver memory 47.
[0236] Once the internal alarm signal has been activated by step
492, it will stay on until the clock/timing sub-system 49 of FIG. 4
indicates that a preset time interval of L3 minutes has elapsed or
the cardiosaver 5 receives a signal from the external alarm system
60 of FIG. 1 requesting the alarm be turned off.
[0237] To save power in the implantable cardiosaver 5, step 496
might check once every minute for the turn off signal from the
external alarm system 60 while the external alarm system 60 would
transmit the signal continuously for slightly more than a minute so
that it will not be missed. It is also envisioned that when the
alarm is sent to the external alarm system 60, the internal clock
49 of the cardiosaver 5 and the external alarm system 60 can be
synchronized so that the programming in the external alarm system
60 will know when to the second, that the cardiosaver will be
looking for the turn off signal.
[0238] At this point in the alarm subroutine 490 step 497 begins to
record and save to event memory 476 of FIG. 4, an E second long
electrogram segment every F seconds for G hours, to allow the
patient's physician and/or emergency room medical professional to
read out the patient's electrogram over time following the events
that triggered the alarm. This is of particular significance if the
patient, his caregiver or paramedic injects a thrombolytic or
anti-platelet drug to attempt to relieve the blood clot causing the
acute myocardial infarction. By examining the data following the
injection, the effect on the patient can be noted and appropriate
further treatment prescribed.
[0239] In step 498 the alarm subroutine will then wait until a
reset signal is received from the physician's programmer 68 or the
patient operated initiator 55 of the external alarm system 60 of
FIG. 1. The reset signal would typically be given after the event
memory 476 of FIG. 4 has been transferred to a component of the
external equipment 7 of FIG. 1. The reset signal will clear the
event memory 476 (step 499) and restart the main program 450 at
step 451.
[0240] If no reset signal is received in L6 hours, then the alarm
subroutine 490 returns to step 451 of FIG. 5 and the cardiosaver 5
will once again begin processing electrogram segments to detect a
cardiac event. If another event is then detected, the section of
event memory 476 used for saving post-event electrogram data would
be overwritten with the pre-event electrogram data from the new
event. This process will continue until all event memory is used.
I.e. it is more important to see the electrogram data leading up to
an event than the data following detection.
[0241] FIG. 9 illustrates the function of the hi/low heart rate
subroutine 420. The hi/low heart rate subroutine is meant to run
when the patient's heart rate is below the normal range (e.g. 50 to
80 beats per minute) or above the elevated range that can occur
during exercise (e.g. 80 to 140 beats per minute). A low heart rate
(bradycardia) may indicate the need for a pacemaker and should
prompt a SEE DOCTOR alert to the patient if it does not go away
after a programmed period of time. Very high heart rate can be
indicative of tachycardia or ventricular fibrillation and is
serious if it does not quickly go away and should warrant a major
event alarm like a detected AMI.
[0242] The hi/low heart rate subroutine 420 begins with step 421
where the electrogram segment of Y seconds collected in steps 453
and 454 of FIG. 5 is saved to the event memory 476 (step 421)
because the patient's doctor may wish to know that the high or low
heart rate occurred. Once the Y second long electrogram segment is
saved, step 422 of the hi/low heart rate subroutine 420 directs the
processing in different directions depending on if the heart rate
is too high, too low or unsteady. If unsteady, the unsteady heart
rate subroutine 410 illustrated in FIG. 12 is run. If it is too
high, step 423 increments the event counter k by 1, then step 424
checks whether the event counter k is equal to 3. Although this
embodiment uses k=3 events as the trigger to run the alarm
subroutine 490 it is envisioned that k=1 or 2 or k values higher
than 3 can also be used.
[0243] In step 424, If k=3 then the alarm subroutine 490
illustrated in FIG. 8 is run. If k less than 3 then in step 425 the
hi/low heart rate subroutine 420 waits for "B" seconds and checks
again in step 426 if the heart rate is still too high. If the heart
rate is still too high, the hi/low heart rate subroutine 420
returns to step 423 where the event counter is incremented by 1. If
the heart rate remains high, the hi/low heart rate subroutine 420
will loop until k is equal to 3 and the alarm subroutine 490 is
run. If the heart rate does not remain high in step 426, the hi/low
heart rate subroutine 420 will return to step 453 of the main heart
signal processing program 450 illustrated in FIG. 5. ST shift
amplitude (and/or T wave shift) is not checked during the high
heart rate section of the hi/low heart rate subroutine 420 as the
presence of a very high heart rate could alter the detection of
changes in ST and PQ segments of the electrogram giving false
indications. Very high heart rate is, by itself, extremely
dangerous to the patient and is therefore a major cardiac
event.
[0244] If in step 422, the heart rate is too low rather than too
high, the hi/low heart rate subroutine 420 will proceed to step 431
where the Y second long electrogram segment is checked for an
excessive ST shift in the same way as step 457 of the main heart
signal processing program 450 illustrated in FIG. 5. In other
words, the ST deviation on M out of N beats must be shifted at
least H. sub.ST(i) from the baseline average ST deviation
.DELTA.V.sub.BASE(i) of the i'th baseline electrogram segment. If
there is a detected excessive ST shift in step 431, the hi/low
heart rate subroutine 420 returns to run the ST shift verification
subroutine 460 illustrated in FIG. 5. As with step 457 of the main
heart signal processing program 450, the detection of M-N+1 OK
beats without excessive ST shift is sufficient for a negative
detection and the program can then proceed on to step 432.
[0245] If there is not an excessive ST shift detected in step 431,
step 432 causes the hi/low heart rate subroutine 420 in step 432 to
wait for "C" seconds then buffer and save a new Y second long
electrogram segment as in steps 453 and 454 of the main heart
signal processing program 450 of FIG. 5. Once the new Y second long
electrogram segment is collected, the hi/low heart rate subroutine
420 checks in step 433 if the heart rate is still too low. If it is
no longer too low, the system returns to step 455 of the main heart
signal processing program 450 illustrated in FIG. 5.
[0246] If the heart rate remains too low, then step 434 checks for
an excessive ST shift as in step 431. If there is an excessive ST
shift in step 434, the hi/low heart rate subroutine 420 returns to
run the ST shift verification subroutine 460 of FIG. 5. If there is
not an excessive ST shift detected in step 434, step 435 causes the
hi/low heart rate subroutine 420 in step 435 to wait for another
"C" seconds then buffer and save another Y second long electrogram
segment as in steps 453 and 454 of the main heart signal processing
program 450 of FIG. 5. Once this Y second long electrogram segment
is collected, the hi/low heart rate subroutine 420 checks in step
436 if the heart rate is still too low (for the 3.sup.rd time). If
it is no longer too low, the system returns to step 455 of the main
heart signal processing program 450 of FIG. 5. If the heart rate
remains too low, then step 437 checks for an excessive ST shift as
in steps 431 and 434. If there is an excessive ST shift in step
437, the hi/low heart rate subroutine 420 returns to run the ST
shift verification subroutine 460 of FIG. 5. If there is not an
excessive ST shift detected in step 437, the step 438 saves the
contents of the most recently collected Y second long electrogram
segment and the to the event memory 476 for later review by the
patient's doctor.
[0247] If the hi/low heart rate subroutine 420 reaches step 438
then the patient's heart rate has been too low even after two waits
of "C" seconds. Now the hi/low heart rate subroutine 420 proceeds
to step 427 to turn on the internal "SEE DOCTOR" alarm signal. Step
427 also sends out to the external alarm system 60 of FIG. 1, a
signal to activate the "SEE DOCTOR" alarm signal of the external
alarm system 60 that may include a text or played speech message
indicating the cause of the alarm. E.G. the external alarm system
speaker 57 of FIG. 1 could emit warning tones and a text message
could be displayed or the speaker 57 might emit a spoken warning
message to the patient.
[0248] Note that during the checking for continued low heart rate,
ST shift amplitudes are still checked after each wait because it is
well known that low heart rate can be a byproduct of an acute
myocardial infarction.
[0249] Finally in step 428, the hi/low heart rate subroutine 420
will keep the "SEE DOCTOR" alarm signal turned on for L4 minutes or
until receipt of a signal from the external alarm system 60 to turn
off the alarm signal. After the "SEE DOCTOR ALERT signal is
enabled, the low heart rate limit, below which the hi/low heart
rate subroutine 420 is run, is changed by step 429 to be just below
the average heart rate measured in step 436. Once the patient is
warned to go see the doctor, additional warnings will be annoying
and therefore the low rate limit is best changed. This allows the
hi/low heart rate subroutine 420 to then return to step 452 of the
main program where it will continue to monitor ST shift amplitudes
to provide early detection of acute myocardial infarction. Actual
programming of the cardiosaver 5 may use R-R interval instead of
heart rate and it is understood that either is sufficient and one
can be easily computed from the other.
[0250] Although steps 431, 434 and 437 indicate the subroutine 420
is to look for an ST shift, other ischemia indications such as T
wave spiking, either alone or in combination with ST shift
detection may be used. Also in steps 431, 434 and 437 if no shift
is detected, the event counter k is reset to 0 if it is not already
0.
[0251] FIG. 10 illustrates the ischemia subroutine 480 that
provides decision making for the cardiosaver 5 in the event of an
elevated heart rate such as that would occur during exercise by the
patient. The ischemia subroutine 480 uses a beat counter j to
indicate the beat within a Y second long electrogram segment. A
beat is defined as a sub-segment containing exactly one R wave of
the Y second long electrogram segment. The ischemia subroutine 480
begins in step 481 by initializing the beat counter j to a value of
2. Then in step 482, the R-R interval range A for the beat j is
determined. For example that there could be between 4 R-R interval
ranges A=1 to 4 of 750 to 670, 670 to 600, 600 to 500 and 500 to
430 milliseconds respectively. These would correspond to heart rate
intervals of 80 to 90, 90 to 100, 100 to 120 and 120 to 140 beats
per minute. The number of ranges A and the upper and lower limit of
each range would be programmable by the patient's physician from
the programmer 68 of FIG. 1.
[0252] Next in step 483 the programmed ischemia multiplier .mu.(A)
is retrieved from the programmable parameters 471 of FIG. 4.
.mu.(A) is the allowable factor increase or decrease in ST shift
detection threshold for the R-R interval range A. In other words,
because the patient may have some ischemia during elevated heart
rates from exercise, the patient's physician can program .mu.(A)s
that are greater than 1 and might increase with each successive
heart rate range. For example, if the R-R interval ranges are 750
to 670, 670 to 600, 600 to 500 and 500 to 430 milliseconds the
corresponding .mu.(A)s might be 1.1, 1.2, 1.3 and 1.5. This would
require that the ST shift in the R-R interval range of A=4 (500 to
430 milliseconds) be one and a half times as large as during normal
heart rates in order to qualify as a cardiac event. It is
envisioned that the patient could undergo an exercise stress test
at a time after implant when the implanted leads have healed into
the wall of the heart and electrogram segments captured by the
cardiosaver 5 during that stress test would be reviewed by the
patient's physician to determine the appropriate range intervals
and ischemia multipliers to help identify a worsening of the
patient's exercise induced ischemia from the time when the stress
test is conducted.
[0253] It is also envisioned that in order to detect smaller
changes in vessel narrowing than a full acute myocardial
infarction, the cardiosaver S of FIGS. 1-4 might use .mu.(A)s that
are less than one. For example, if the R-R interval ranges are 750
to 670, 670 to 600, 600 to 500 and 500 to 430 milliseconds the
corresponding .mu.(A)s might be 0.5, 0.6, 0.7 and 0.8. Thus in this
example, in the R-R interval range of 750 to 670 milliseconds, the
threshold for ischemia detection would be half of what it is for
the normal heart rate range.
[0254] Once the ischemia multiplier has been retrieved, step 484
calculates the ischemia ST shift threshold .theta.(A) for the R-R
interval range A where .theta.(A)=H.sub.ST(i).times. .mu.(A) where
H.sub.ST(i) is the current ST shift threshold for normal heart
rates. Next in step 485, the ischemia subroutine 480 checks if for
the beat j the ST shift is greater than the ischemia threshold
.theta.(A). If it is not greater, step 487 then checks if the N'th
beat has been examined. If the ST shift of the j'th beat exceeds
the ischemia threshold .theta.(A) then step 486 checks if M beats
with ST shifts greater than .theta.(A) have been seen. If they have
not been seen proceed to step 487. If in step 487, the Nth beat has
been examined, return to step 451 of the main heart signal
processing program 450 of FIG. 5. If N beats have not yet been
examined, increment j by 1 in step 489 and loop back to step
482.
[0255] If M beats with excessive ST shift are found by step 486,
step 581 saves the current Y second long electrogram segment to the
Event Memory 476, then in step 582 the event counter k is
incremented by 1 followed by step 583 checking if k is equal to 3.
If k is less than 3 then the ischemia subroutine 480 continues by
sleeping for Z seconds in step 584, then buffering a new Y second
long electrogram segment in step 585, saving in step 586 the new Y
second long electrogram segment to the next location in recent
electrogram memory 472 of FIG. 4. and then checking if the heart
rate is still elevated in step 587. If the heart rate is still
elevated in step 587, the loop checking for ischemia is run again
starting with step 481. If the heart rate is no longer elevated
then step 588 checks if the heart rate is too high, too low or
unsteady. If such is the case, the hi/low heart rate subroutine 420
is run. If the heart rate is not high, low or unsteady, the
ischemia subroutine 480 ends and the program returns to step 469 of
the ST shift verification subroutine 460 of FIG. 5. This will allow
an excessive ST shift detected at elevated heart rate that stays
shifted when the heart rate returns to normal to quickly trigger
the AMI alarm. This works because k is either 1 or 2 at this point
so either 2 or 1 more detection of excessive ST shift with normal
heart rate will cause a major event AMI alarm. If however k=3 in
step 582, then the last detection of excessive ST shift occurred
during an elevated heart rate and will be treated as exercise
induced ischemia rather than an acute myocardial infarction.
[0256] So if k=3 (i.e. exercise induced ischemia has been detected)
in step 582 the ischemia subroutine 480 moves on to step 681 where
it checks if it has been more than L5 minutes since the first time
that exercise induced ischemia was detected where k=3 in step
583.
[0257] If it has been less than L5 minutes since the first
detection of exercise induced ischemia then the internal SEE DOCTOR
ALERT signal is turned on by step 682 if it has not already been
activated.
[0258] If it has been more than L5 minutes, then the alarm
subroutine 490 is run. This will change the SEE DOCTOR ALERT signal
previously started in step 682 to a major event AMI alarm if the
excessive ST shift at an elevated heart rate does not go away
within L5 minutes. Similarly, if the patient stops exercising and
his heart rate returns to normal but the excessive ST shift
remains, then the alarm subroutine 490 will also be run.
[0259] If it has been less than L5 minutes and the SEE DOCTOR alert
signal has not been already been activated, step 683 next sends a
message to the external alarm system 60 of FIG. 1 to activate the
SEE DOCTOR external alarm signal and indicate to the patient by a
text of spoken message that he should stop whatever he is doing,
and sit or lie down to get his heart rate to return to normal.
Following this, in step 684 the ischemia subroutine 480 will keep
the SEE DOCTOR ALERT signal on for L4 minutes from the first time
it is turned on or until the receipt of an off signal from the
alarm disable button 59 of the external alarm system 60 of FIG. 1.
The program then returns to step 451 of the main program 451 of
FIG. 5 to continue to examine the patient's heart signals.
[0260] FIG. 11 diagrams the alarm conditions 600 that are examples
of the combinations of major and minor events that can trigger an
internal alarm signal (and/or external alarm signal for the
guardian system of FIG. 1. Box 610 shows the combinations 611
through 617 of major cardiac events that can cause the alarm
subroutine 490 to be run. These include the following:
[0261] 611. 3 ST shift events (detections of excessive ST shift)
with either a normal heart rate or a low heart rate.
[0262] 612. 2 ST shift events with a normal or low heart rate and 1
event from heart rate too high.
[0263] 613. 1 ST shift event with a normal or low heart rate and 2
events from heart rate too high.
[0264] 614. 3 events from heart rate too high.
[0265] 615. 3 ST shift events with either a normal, low or elevated
heart rate (ischemia) where the last detection is at a normal or
low heart rate.
[0266] 616. 3 events (excessive ST shift or high heart rate) where
the last event is high heart rate.
[0267] 617. An ischemia alarm indication from conditions in box 620
that remains for more than L5 minutes after the first detection of
ischemia.
[0268] The ischemia alarm conditions 620 include:
[0269] 621. 3 ST shift events with either a normal, low or elevated
heart rate (ischemia) where the last detection is at an elevated
heart rate.
[0270] 622. Any 3 events including a too high heart rate event
where the last detection is an excessive ST shift at an elevated
heart rate.
[0271] If either of the ischemia alarm conditions 620 is met and it
is less than L5 minutes since the exercise induced ischemia was
first detected, then the SEE DOCTOR ALERT signal will be turned on
by step 682 of the ischemia subroutine 480 if it has not already
been activated.
[0272] Box 630 shows the other minor event alarm conditions
including the bradycardia alarm condition 632 that is three
successive electrogram segments collected with heart rate too low
and the unsteady heart rate alarm condition 635 that is caused by
more than P.sub.unsteady % of beats having a too short R-R
interval. If here are too many (as programmed by the doctor)
consecutive electrogram segments with insufficient normal beats 637
to be able to process for cardiac event detection, the programming
may need modification or there is something else wrong. These will
trigger the SEE DOCTOR alert signal initiated by step 427 of the
hi/low heart rate subroutine 420 for the bradycardia alarm
condition 632 and step 416 of the unsteady hart rate subroutine 410
for the unsteady heart rate alarm condition 635. Also triggering
the SEE DOCTOR alert signal is a low battery condition 636.
[0273] FIG. 12 is a block diagram illustrating the unsteady heart
rate subroutine 410. The subroutine 410 is run if the R-R interval
varies greatly over many of the beats in the Y second long
electrogram segment collected by steps 453 and 454 of the main
heart signal processing program 450. As previously described, one
technique for identifying such an unsteady heart rate is to compare
the two shortest R-R intervals and the 2 longest intervals. If the
difference between the both of the two shortest and the average of
the two longest R-R intervals are more than a programmed percentage
a, an unsteady heart rate is identified. For example the programmed
percentage .alpha. might be 25% so that if the two shortest R-R
intervals are each more than 25% less than the average of the two
longest R-R intervals, then the heart rate is unsteady. It is
envisioned that if a longer time Y is used for electrogram segment
collection then it might require 3 or more "short" beats to
indicated an unsteady heart rate. If there is zero or one short
beat, the main heart signal processing program 450 will move on to
step 456 having marked all of the "normal" beats in the Y second
long electrogram segment. A normal beat is defined as a beat
including where the R-R intervals before and after the R wave are
both in the normal range (i.e. not too short).
[0274] The unsteady heart rate subroutine 410 begins in step 411 by
checking for at least N normal beats in the most recently collected
electrogram data. When the subroutine begins there is only one Y
second long electrogram segment being examined. If there are not N
normal beats, then the subroutine 410 will wait X seconds in step
419 before an additional Y second long electrogram segment is
collected in step 412 after the. Step 411 then will check for N
normal beats in the two Y second long electrogram segments (i.e. 2Y
seconds of electrogram data). This loop of steps 411 and 412, where
each time Y additional seconds of electrogram is collected, will
continue until N normal beats are found.
[0275] It is envisioned that step 411 could also check for beats
with elevated heart rate R-R intervals or might include elevated
heart rate beats as "normal" beats by expanding the allowed range
of the R-R interval for a normal beat. Once N "normal" beats are
found by step 411, then step 413 checks for an excessive ST shift
in M out of the N normal beats similar to step 457 of FIG. 5. Step
413 could also (as in step 457 of FIG. 5) look for an excessive T
wave shift. If an excessive ST shift (and/or T wave shift) is
detected by step 413, the program returns to the ST shift
verification subroutine 460 of FIG. 5.
[0276] If excessive ST shift (and/or T wave shift) are not detected
by step 413, then step 414A checks if more than P.sub.unsteady % of
all the beats (not just the normal beats) in the electrogram data
collected have a too short R-R interval as defined above by the
programmed parameter a. If not the program returns to step 451 of
the main heart signal processing program 450 of FIG. 5. If,
however, more than P.sub.unsteady % of the beats have a short R-R
interval, then step 414B ascertains if there have been N.sub.u
sequential electrogram segments having more than P.sub.unsteady %
of the beats with short R-R intervals. If the number is less than
Nu then this then the program returns to step 451 of the main heart
signal processing program 450 of FIG. 5. If the number is Nu then
step 415 saves all the current electrogram data to event memory 476
of FIG. 4 and step 416 turns on the SEE DOCTOR alert signal with
the internal alarm sub-system 48 of FIG. 4 and also initiates an
external alarm signal by the external alarm system 60 of FIG. 1
with a text or spoken message to the patient indicating that the
SEE DOCTOR alert signal is the result of detection of unsteady
heart rate. As in the case of other SEE DOCTOR alert signals, step
417 will keep the "See Doctor" alarm mechanism turned on for L4
minutes from the first detection of unsteady heart rate or until
receipt of a signal from the external alarm system 60 to turn off
the alarm. To avoid continuously alarming the patient, once the SEE
DOCTOR alert has sounded, the system will wait for a preset time
programmed by the patient's physician before allowing reactivation
of the SEE DOCTOR ALERT. Alternately, there may be a default wait
period such as 12 hours or 1 day or the system may be programmed to
only sound the SEE DOCTOR alert once for each indication until
reset by the physician's programmer.
[0277] FIG. 13 shows a modified embodiment of the guardian system
510. The cardiosaver implant 505 with lead 512, electrode 514,
antenna 516, header 520 and metal case 511 would be implanted
subcutaneously in a patient at risk of having a serious cardiac
event such as an acute myocardial infarction. The lead 512 could be
placed either subcutaneously or into the patient's heart. The case
511 would act as the indifferent electrode. The system 510 also
included external equipment that includes a physician's programmer
510 an external alarm transceiver 560 and a pocket PC 540 with
charger 566. The external alarm transceiver 560 has its own battery
561 and includes an alarm disable button 562 radiofrequency
transceiver 563, speaker 564, antenna 565 and standard interface
card 552. The cardiosaver 505 has the same capabilities as the
cardiosaver 5 of FIGS. 1 through 4.
[0278] The standardized interface card 552 of the external alarm
transceiver 510 can be inserted into a standardized interface card
slot in a handheld or laptop computer. The pocket PC 540 is such a
handheld computer. The physician's programmer 510 is typically a
laptop computer. Such standardized card slots include compact flash
card slots, PCMCIA adapter (PC adapter) card slots, memory stick
card slots, Secure Digital (SD) card slots and Multi-Media card
slots. The external alarm transceiver 510 is designed to operate by
itself as a self-contained external alarm system, however when
inserted into the standardized card slot in the pocket PC 540, the
combination forms an external alarm system with enhanced
functionality. For example, in stand alone mode without the pocket
PC 540, the external alarm transceiver 560 can receive alarm
notifications from the cardiosaver implant 505 and can produce an
external alarm signal by generating one or more sounds through the
speaker 564. These sounds can wake the patient up or provide
additional alerting to that provided by the internal alarm signal
generated by the cardiosaver 505. The alarm disable button 562 can
acknowledge and turn off both external and internal alarm signals.
The standalone external alarm transceiver 560 therefore provides
key functionality could be small enough to wear on a chain around
the neck or on a belt.
[0279] When plugged into the pocket PC 540, the external alarm
transceiver 560 can facilitate the display of text messages to the
patient and electrogram data that is transmitted from the
cardiosaver 505. The pocket PC 540 also enables the patient
operated initiator 55 and panic button 52 capabilities of the
external alarm system 60 of FIG. 1. Being a pocket PC also readily
allows connection to wireless communication capabilities such as
wireless internet access that will facilitate retransmission of
data to a medical practitioner at a geographically remote location.
It is also envisioned that the charger 566 could recharge the
batter 551 when the external alarm adaptor 560 is plugged into the
pocket PC 540.
[0280] The external alarm transceiver 560 can also serve as the
wireless two-way communications interface between the cardiosaver
505 and the programmer 510. The physician's programmer 510 is
typically a laptop computer running some version of the Microsoft
Windows operating system. As such, any or the above standardized
slot interfaces can be either directly interfaced to such a laptop
computer or interfaced using a readily available conversion
adaptor. For example, almost all laptop computers have a PCMCIA
slot and PCMCIA card adaptors are available for compact flash
cards, Secure Digital cards etc. Thus the external alarm adaptor
560 could provide the interface to the physician's programmer 510.
This provides additional security as each cardiosaver implant 505
and external alarm adaptor 560 could be uniquely paired with built
in security codes so that to program the implant 505, the physician
would need the patient's external alarm adaptor 560 that would act
both as a wireless transceiver and as a security key.
[0281] Although the guardian system 10 as described herein could
clearly operate as a stand-alone system, it is clearly conceivable
to utilize the guardian system 10 with additional pacemaker or
implanted defibrillator circuitry. As shown in FIG. 4, pacemaker
circuitry 170 and/or defibrillator circuitry 180 could be made part
of any cardiosaver 5 or 505. Furthermore, two separate devices (one
pacemaker or one defibrillator plus one cardiosaver 5) could be
implanted within the same patient.
[0282] FIG. 14 illustrates a preferred physical embodiment of the
external alarm transceiver 560 having standardized interface card
552, alarm disable button 562 labeled "ALARM OFF" and speaker 564.
It is also envisioned that by depressing and holding the alarm
disable button 562 for a minimum length of time, when there is not
an alarm, the external alarm transceiver could verify the
operational status of the cardiosaver 505 and emit a confirming
sound from the speaker 564.
[0283] FIG. 15 illustrates the physical embodiment of the combined
external alarm transceiver 560 and pocket PC 540 where the
standardized interface card 552 has been inserted into a matching
standardized interface card slot the pocket PC 540. The screen 542
of the pocket PC 540 shows an example of the display produced by an
external alarm system following the detection of an acute
myocardial infarction by the cardiosaver 505. The screen 542 of
FIG. 15 displays the time of the alarm, the recent electrogram
segment from which the cardiac event was detected and the baseline
electrogram segment used for comparison in the cardiac event
detection. Such a display would greatly facilitate diagnosis of the
patient's condition upon arrival at an emergency room and could
eliminate the need for additional electrocardiogram measurements
before the patient is treated.
[0284] FIG. 16 shows and advanced embodiment of the external alarm
transceiver 720 having a battery 721, an alarm disable button 722,
a RF transceiver for data communication to and from the implanted
device, a loudspeaker 724, a microphone 727, a local area wireless
interface 723, a standard interface 728 and a long distance (LD)
voice/data communication interface 729. The function of the alarm
disable button 722 and the radiofrequency transceiver 723 are as
described for the similar devices shown in FIG. 13.
[0285] The local area wireless interface 723 provides wireless
communication within a building (e.g. home, doctor's office or
hospital) to and from the implant 505 with lead 512 and antenna 516
through the external alarm transceiver 720 from and to assorted
external equipment such as
[0286] Pocket PCs 702, Palm OS PDAs, Notebook PCs, physician's
programmers 704 and tablet diagnostic systems 706. The means for
transmission from the local area wireless interface 723 may be by
radiofrequency or infra-red transmission. A preferred embodiment of
the local area wireless interface 723 would use a standardized
protocol such as IRDA with infra-red transmission and Bluetooth or
WiFi (802.11.a, b, or g) with radiofrequency transmission. The
local area wireless interface 723 would allow display of implant
data and the sending of commands to the implant 505.
[0287] The standard interface 728 provides a physical (wired)
connection for data communication with devices nearby to the
patient for the purposes of displaying data captured by the implant
505 and for sending commands and programs to the implant 505. The
standard interface 728 could be any standard computer interface;
for example: USB, RS-232 or parallel data interfaces. The pocket PC
702 and physician's programmer 704 would have functionality similar
to the pocket PC 540 and physician's programmer 510 of FIG. 13.
[0288] The tablet diagnostic system 706 would provide a level of
functionality between that of the pocket PC 702 and physician's
programmer 706. For example, the tablet diagnostic system would
have the programmer's ability to download complete data sets from
the implant 505 while the pocket PC is limited to alarm and
baseline electrogram segments or the most recent electrogram
segment. The tablet diagnostic system 706 would be ideal for an
emergency room to allow emergency room medical professionals to
quickly view the electrogram data stored within the implant 505 to
assess the patient's condition. The recently introduced Tablet PCs
such as the Toshiba Portege 3500 or the Compaq TC1000 have IRDA,
WiFi and USB interfaces built into them and so would make an ideal
platform for the tablet diagnostic system 706. It is envisioned
that such a tablet diagnostic system in an emergency room or
medical clinic would preferably be connected to its own external
alarm transceiver. The tablet diagnostic system 706 could be hand
held or mounted on a wall or patient bed. A unit located near the
bed of an incoming patient having a guardian implant 505 would
enable display of patient diagnostic data without requiring any
attachments to the patient. Such wireless diagnosis is similar to
that envisioned for the tricorder and diagnostic beds of the Star
Trek science fiction series created by Gene Roddenberry.
[0289] The long distance voice/data communication interface 729
with microphone 727 and also attached to the loudspeaker 724 will
provide the patient with emergency contact with a remote diagnostic
center 708. Such a system could work much like the ONSTAR emergency
assistance system now built into many cars. For example, when a
major or EMERGENCY alarm is identified by the guardian implant 505,
the following steps could be followed:
[0290] 1. The guardian will first ascertain if an external alarm
transceiver is within range, if not the internal alarm will be
initiated.
[0291] 2. If the external alarm transceiver is within range the
system will next see if there is access to the remote diagnostic
center 708 through the long distance voice/data communication
interface 729. If not the external alarm transceiver 720 and
implant 505 will initiate internal and/or external alarm
notification of the patient.
[0292] 3. If there is access to the remote diagnostic center 708
the long distance voice/data communication interface 729, the
patient alarm information including alarm and baseline electrogram
segments will be transmitted to the remote diagnostic center 708. A
medical professional at the remote diagnostic center 708 will view
the data and immediately establish voice communication to the
external alarm transceiver 720 through the long distance voice/data
communication interface 729. If this occurs, the first thing that
the patient will hear is a ringing tone and/or a voice announcement
followed by the contact with the medical professional who can
address the patient by name and facilitate appropriate emergency
care for the patient. In this case, the internal and external
alarms will not be needed and to the patient it will resemble an
incoming telephone call from the medical professional. It is also
envisioned that the voice of the medical professional could be the
first thing that the patient hears although an initial alerting
signal is preferred.
[0293] This method of establishing the highest level of
communication available to the guardian system with the fall back
of just the internal alarm will provide the best possible patient
alerting based on what is available at the time of the alarm.
[0294] The data communications between the external alarm
transceiver 720 and the remote diagnostic center 708 would utilize
a standardized (or custom) data communications protocol. For
example, the data communications might utilize any or all of the
following either within a private network, a VPN, an intranet (e.g.
a single provider network such as the Sprint data network) or
through the public internet:
[0295] 1. Basic TCP/IP messaging within a single network or through
the internet.
[0296] 2. Short Messaging Service (SMS)
[0297] 3. Multimedia Message Service (MMS) used for cell phone
transmission
[0298] 4. Universal Datagram Protocol (UDP)
[0299] It is also envisioned that the present invention would take
advantage of existing telephone network call center technology
including use of Automatic Number Identification (ANI) to identify
the incoming call, and Dialed Number Identification Service (DNIS)
where different numbers might be dialed by the external alarm
transceiver 720 depending on the severity of the detected cardiac
event. For example, in the case where the call is placed by the
emergency alarm transceiver 720, an EMERGENCY alarm might dial a
different number than a SEE DOCTOR alert which might be different
from a patient-initiated "panic button" call. DNIS could help get
the appropriate help for the patient even if data connectivity is
unavailable and might be used to prioritize which call is answered
first (e.g., an EMERGENCY alarm would have higher priority than a
SEE DOCTOR alert).
[0300] It is also envisioned that the remote diagnostic center 708
could facilitate the scheduling of an appointment with the
patient's doctor following a SEE DOCTOR alert.
[0301] Although throughout this specification all patients have
been referred to in the masculine gender, it is of course
understood that patients could be male or female. Furthermore,
although the only electrogram indications for an acute myocardial
infarction that are discussed herein are shifts involving the ST
segment and T wave height, it should be understood that other
changes in the electrogram (depending on where in the heart the
occlusion has occurred and where the electrodes are placed) could
also be used to determine that an acute myocardial infarction is
occurring. Furthermore, sensors such as heart motion sensors, or
devices to measure pressure, pO.sub.2 or any other indication of an
acute myocardial infarction or cardiac events could be used
independently or in conjunction with a ST segment or T wave shift
detectors to sense a cardiac event.
[0302] It is also envisioned that all of the processing techniques
described herein for an implantable cardiosaver are applicable to a
guardian system configuration using skin surface electrodes and a
non-implanted cardiosaver 5 the term electrogram would be replaced
by the term electrocardiogram. Thus the cardiosaver device
described in FIGS. 5 through 12 would also function as a monitoring
device that is completely external to the patient.
[0303] Various other modifications, adaptations, and alternative
designs are of course possible in light of the above teachings.
Therefore, it should be understood at this time that, within the
scope of the appended claims, the invention can be practiced
otherwise than as specifically described herein.
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