# US 11,439,830 B2 · T-wave morphology analysis for pathological event detection

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- Number: US 11,439,830 B2
- Document ID: US11439830B2
- Status: Granted
- Kind: B2
- Application number: 16/825,291
- Filed: 2020-03-20
- Published: 2020-09-24
- Granted: 2022-09-13
- Earliest claimed: 2019-03-21
- Assignees: Medtronic, Inc.
- Applicants: Medtronic, Inc.
- Inventors: Inna A. Pikulenko; Gary L. Berg; Jeffrey M. Gillberg
- Web page: https://patentgrep.com/patent/US11439830B2

## CPC

- A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)}
- A61N 1/3621: {for treating or preventing abnormally high heart rate}
- A61B 5/29: for permanent or long-term implantation
- A61B 5/35: by template matching
- A61B 5/363: Detecting tachycardia or bradycardia
- A61B 5/366: Detecting abnormal QRS complex, e.g. widening
- A61B 5/4848: {Monitoring or testing the effects of treatment, e.g. of medication}
- A61B 5/7246: {using correlation, e.g. template matching or determination of similarity}
- A61B 5/74: {Details of notification to user or communication with user or patient; User input means}
- A61N 1/36521: {the parameter being derived from measurement of an electrical impedance}
- A61N 1/36535: {controlled by body position or posture}
- A61N 1/3655: {controlled by body or blood temperature}
- A61N 1/36557: {controlled by chemical substances in blood}
- A61N 1/36585: {controlled by two or more physical parameters}
- A61N 1/36592: {controlled by the heart rate variability}
- A61B 5/021: Measuring pressure in heart or blood vessels
- A61B 5/024: Measuring pulse rate or heart rate
- A61B 5/053: Measuring electrical impedance or conductance of a portion of the body
- A61B 5/08: Measuring devices for evaluating the respiratory organs
- A61B 5/145: Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value {; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue} (non-radiation detecting or locating of foreign bodies in blood A61B5/06)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

A medical device senses cardiac electrical signals including T-waves attendant to ventricular myocardial repolarizations and detects a T-wave template condition associated with non-pathological changes in T-wave morphology. The device generates a T-wave template from T-waves sensed by the sensing circuit during the T-wave template condition. After generating the T-wave template, the device acquires a T-wave signal from the cardiac electrical signal and compares the acquired T-wave signal to the T-wave template. The device detects a pathological event in response to the acquired T-wave signal not matching the T-wave template.

## Claims

### Claim 1

A medical device, comprising:
a sensing circuit configured to:
sense a cardiac electrical signal comprising T-waves attendant to ventricular myocardial repolarizations; and
sense ventricular events attendant to ventricular myocardial depolarizations from the cardiac electrical signal according to a plurality of ventricular sensing control parameters; and
a control circuit configured to:
detect a first T-wave template condition;
generate a first T-wave template from at least one T-wave sensed by the sensing circuit during the detected first T-wave template condition;
after generating the first T-wave template, acquire a first T-wave signal from the cardiac electrical signal sensed by the sensing circuit;
compare the acquired first T-wave signal to the first T-wave template;
determine that the first T-wave signal does not match the first T-wave template;
detect a pathological event in response to at least the acquired first T-wave signal not matching the first T-wave template; and
after detecting the pathological event, adjust at least one of the plurality of ventricular sensing control parameters used by the sensing circuit for sensing the ventricular events attendant to ventricular myocardial depolarizations; and
a therapy delivery circuit configured to deliver a therapy to alleviate or prevent the pathological event in response to the control circuit detecting the pathological event.

### Claim 2 (depends on 1)

The device of claim 1, wherein the control circuit is further configured to:
identify a plurality of T-wave template conditions including the first T-wave template condition;
for each respective one of the plurality of T-wave template conditions, generate a T-wave template from T-waves of the cardiac electrical signal sensed by the sensing circuit during the respective one of the plurality of T-wave template conditions;
detect a first current T-wave template condition present at a first time that the first T-wave signal is being acquired from the cardiac electrical signal; and
select the first T-wave template from the plurality of generated T-wave templates based on the detected first current T-wave template condition.

### Claim 3 (depends on 2)

The device of claim 2, wherein the control circuit is further configured to:
acquire a second T-wave signal from the cardiac electrical signal sensed by the sensing circuit;
detect a second current T-wave template condition present at a second time that the second T-wave signal is being acquired, the second current T-wave template condition being different than the first current T-wave template condition;
select a second T-wave template from among the plurality of generated T-wave templates based on the second current T-wave template condition;
compare the acquired second T-wave signal to the selected second T-wave template; and
detect the pathological event in response to at least one of the first acquired T-wave signal not matching the selected first T-wave template and the second acquired T-wave signal not matching the selected second T-wave template.

### Claim 4 (depends on 2)

The device of claim 2, wherein the control circuit is configured to identify each of the plurality of T-wave template conditions by identifying at least one of a heart rate, a paced rhythm condition, an intrinsic atrial rhythm, a patient body posture, a patient activity level, a bioimpedance, a body temperature, and a QRS signal change.

### Claim 5 (depends on 2)

The device of claim 2, further comprising a memory having a plurality of bins, each of the plurality of bins configured to store one of the plurality of T-wave templates, a respective T-wave template condition and a status flag;
wherein the control circuit is configured to;
set the status flag to complete in response to the respective T-wave template being generated from a requisite number of T-wave signals acquired during the respective T-wave template condition, and
set the status flag to incomplete in response to less than the requisite number of T-wave signals for generating the T-wave template being acquired during the respective T-wave template condition.

### Claim 6 (depends on 2)

The device of claim 2, wherein:
the control circuit is further configured to:
identify the plurality of different T-wave template conditions by identifying a plurality of different heart rates;
detect a ventricular tachyarrhythmia rate of the sensed ventricular events that is greater than a tachyarrhythmia detection rate threshold;
estimate an actual heart rate that is less than the tachyarrhythmia detection rate based on the rate of the sensed ventricular events;
select the first T-wave template from the plurality of T-wave templates based on the estimated actual heart rate; and
withhold a ventricular tachyarrhythmia detection in response to at least the first T-wave signal matching the selected first T-wave template.

### Claim 7 (depends on 6)

The device of claim 6, wherein the control circuit is further configured to:
detect T-wave oversensing in response to the first T-wave signal matching the selected first T-wave template; and
in response to detecting the T-wave oversensing, adjust at least one of the plurality of the ventricular sensing control parameters used by the sensing circuit for sensing ventricular events.

### Claim 8 (depends on 6)

The device of claim 6, wherein the control circuit is further configured to:
determine a plurality of sensed ventricular event intervals;
in response to the first T-wave signal not matching the selected first one of the T-wave templates, establish T-wave detection criteria based on the plurality of sensed ventricular event intervals;
compare the plurality of sensed ventricular event intervals to the T-wave detection criteria;
determine that the T-wave detection criteria are met by the plurality of sensed ventricular event intervals; and
detect the pathological event in response to at least the first T-wave signal not matching the first T-wave template and determining that the T-wave detection criteria are met.

### Claim 9 (depends on 1)

The device of claim 1, wherein the control circuit is configured to generate the first T-wave template by:
adjusting a ventricular sensing control parameter of the plurality of ventricular sensing control parameters used by the sensing circuit for sensing ventricular events;
acquiring a plurality of T-wave signals sensed from the cardiac electrical signal during the adjusted ventricular sensing control parameter; and
generating the T-wave template from the acquired plurality of T-wave signals.

### Claim 10 (depends on 9)

The device of claim 9, wherein the control circuit is further configured to acquire each of the plurality of T-wave signals by:
determining a ventricular event interval from the sensed ventricular events attendant to ventricular myocardial depolarizations;
establishing T-wave detection criteria based on the ventricular event interval;
identifying three cardiac events sensed consecutively by the sensing circuit during the adjusted ventricular sensing control parameter;
determining two consecutive event intervals between the three cardiac events;
comparing the two consecutive event intervals to the T-wave detection criteria;
determining that the two consecutive event intervals meet the T-wave detection criteria; and
in response to the two consecutive event intervals meeting the T-wave detection criteria, acquire at least one of the plurality of T-wave signals corresponding to at least one of the three cardiac events.

### Claim 11 (depends on 1)

The device of claim 1, further comprising a sensor configured to produce a sensor signal correlated to the pathological event,
wherein the control circuit is configured to determine that the pathological event is suspected in response to a change in the sensor signal; and
compare the first T-wave signal to the first T-wave template in response to determining that the pathological event is suspected.

### Claim 12 (depends on 1)

The device of claim 1, wherein the control circuit is configured to detect the pathological event by detecting a non-cardiac pathological event in response to the acquired first T-wave signal not matching the T-wave template.

### Claim 13 (depends on 1)

The device of claim 1, wherein the control circuit is configured to detect the pathological event by detecting one of: epileptic seizure, hyperglycemia, hypoglycemia, hyperkalemia, hypokalemia, renal failure, hypervolemia, hypovolemia, edema, medication overdosing, medication under-dosing, cardiac conduction block, or tachyarrhythmia.

### Claim 14

A method comprising:
sensing a cardiac electrical signal comprising T-waves attendant to ventricular myocardial repolarizations;
sensing ventricular events attendant to ventricular myocardial depolarizations from the cardiac electrical signal according to a plurality of ventricular sensing control parameters;
detecting a first T-wave template condition;
generating a first T-wave template from at least one T-wave sensed during the detected first T-wave template condition;
after generating the first T-wave template, acquiring a first T-wave signal from the sensed cardiac electrical signal;
comparing the acquired first T-wave signal to the first T-wave template;
determining that the acquired first T-wave signal does not match the T-wave template;
detecting a pathological event in response to determining that the acquired first T-wave signal does not match the T-wave template;
after detecting the pathological event, adjusting at least one of the plurality of ventricular sensing control parameters used for sensing the ventricular events attendant to ventricular myocardial depolarizations; and
delivering a therapy to alleviate the pathological event in response to detecting the Pathological event.

### Claim 15 (depends on 14)

The method of claim 14, further comprising:
identifying a plurality of T-wave template conditions including the first T-wave template condition;
for each respective one of the plurality of T-wave template conditions, generating a T-wave template from T-waves sensed from the cardiac electrical signal during the respective one of the plurality of T-wave template conditions;
detecting a first current T-wave template condition present at a first time that the first T-wave signal is being acquired from the cardiac electrical signal; and
selecting the first T-wave template from the plurality of generated T-wave templates based on the detected first current T-wave template condition.

### Claim 16 (depends on 15)

The method of claim 15, further comprising:
acquiring a second T-wave signal from the sensed cardiac electrical signal;
detecting a second current T-wave template condition present at a second time that the second T-wave signal is being acquired, the second current T-wave template condition being different than the first current T-wave template condition;
selecting a second T-wave template from among the plurality of generated T-wave templates based on the second current T-wave template condition;
comparing the acquired second T-wave signal to the selected second T-wave template; and
detecting the pathological event in response to at least one of the first acquired T-wave signal not matching the selected first T-wave template and the second acquired T-wave signal not matching the selected second T-wave template.

### Claim 17 (depends on 15)

The method of claim 15, further comprising identifying each of the plurality of T-wave template conditions by identifying at least one of a heart rate, a paced rhythm condition, an intrinsic atrial rhythm, a patient body posture, a patient activity level, a bioimpedance, a body temperature, and a QRS signal change.

### Claim 18 (depends on 15)

The method of claim 15, further comprising:
storing each one of the plurality of T-wave templates with a respective T-wave template condition and status flag;
setting the status flag to complete in response to the respective T-wave template being generated from a requisite number of T-wave signals acquired during the respective T-wave template condition, and
setting the status flag to incomplete in response to less than the requisite number of T-wave signals for generating the T-wave template being acquired during the respective T-wave template condition.

### Claim 19 (depends on 15)

The method of claim 15, further comprising:
identifying the plurality of different T-wave template conditions by identifying a plurality of different heart rates;
detecting a ventricular tachyarrhythmia rate of the sensed ventricular events that is greater than a tachyarrhythmia detection rate threshold;
estimating an actual heart rate that is less than the tachyarrhythmia detection rate based on the rate of the sensed ventricular events;
selecting the first T-wave template from the plurality of T-wave templates based on the estimated actual heart rate; and
withholding a ventricular tachyarrhythmia detection in response to at least the first T-wave signal matching the selected first T-wave template.

### Claim 20 (depends on 19)

The method of claim 19, further comprising:
detecting T-wave oversensing in response to the first T-wave signal matching the selected first T-wave template; and
in response to detecting the T-wave oversensing, adjusting at least one of the plurality of ventricular sensing control parameters used for sensing the ventricular events.

### Claim 21 (depends on 19)

The method of claim 19, further comprising:
determining a plurality of sensed ventricular event intervals;
in response to the first T-wave signal not matching the selected first one of the T-wave templates, comparing the plurality of sensed ventricular event intervals to T-wave detection criteria;
determining that T-wave detection criteria are met by the plurality of sensed ventricular event intervals; and
detecting the pathological event in response to at least the first T-wave signal not matching the first T-wave template and determining that the T-wave detection criteria are met.

### Claim 22 (depends on 14)

The method of claim 14, wherein generating the first T-wave template comprises:
adjusting a ventricular sensing control parameter of the plurality of ventricular sensing control parameters;
acquiring a plurality of T-wave signals sensed from the cardiac electrical signal during the adjusted ventricular sensing control parameter; and
generating the T-wave template from the acquired plurality of T-wave signals.

### Claim 23 (depends on 22)

The method of claim 22, wherein acquiring each of the plurality of T-wave signals comprises:
identifying three cardiac events sensed consecutively during the adjusted ventricular sensing control parameter;
determining two consecutive event intervals between the three cardiac events;
comparing the two consecutive event intervals to T-wave detection criteria;
determining that the two consecutive event interval meet the T-wave detection criteria; and
in response to the two consecutive event intervals meeting the T-wave detection criteria, acquire at least one of the plurality of T-wave signals corresponding to at least one of the three cardiac events.

### Claim 24 (depends on 14)

The method of claim 14, further comprising:
producing a sensor signal correlated to the pathological event,
determining that the pathological event is suspected in response to a change in the sensor signal; and
comparing the first T-wave signal to the first T-wave template in response to determining that the pathological event is suspected.

### Claim 25 (depends on 14)

The method of claim 14, further comprising detecting the pathological event by detecting a non-cardiac pathological event in response to the acquired first T-wave signal not matching the T-wave template.

### Claim 26 (depends on 15)

The method of claim 15, wherein detecting the pathological event comprises detecting one of: epileptic seizure, hyperglycemia, hypoglycemia, hyperkalemia, hypokalemia, renal failure, hypervolemia, hypovolemia, edema, medication overdosing, medication under-dosing, cardiac conduction block, or tachyarrhythmia.

### Claim 27

A non-transitory, computer-readable storage medium comprising a set of instructions which, when executed by a medical device, cause the medical device to:
sense a cardiac electrical signal comprising T-waves attendant to ventricular myocardial repolarizations;
sense ventricular events attendant to ventricular myocardial depolarizations from the cardiac electrical signal according to a plurality of ventricular sensing control parameters;
detect a T-wave template condition;
generate a T-wave template from at least one T-wave sensed from the cardiac electrical signal during the detected T-wave template condition;
after generating the T-wave template, acquire a T-wave signal from the sensed cardiac electrical signal;
compare the acquired T-wave signal to the T-wave template;
determine that the T-wave signal does not match the T-wave template;
detect a pathological event in response to the acquired T-wave signal not matching the T-wave template;
after detecting the pathological event, adjust at least one of the plurality of ventricular sensing control parameters used for sensing ventricular events attendant to ventricular myocardial depolarizations; and
deliver a therapy to alleviate the pathological event in response to detecting the Pathological event.