# US 10,765,359 B2 · Device-based detection and monitoring of sleep apnea conditions

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- Number: US 10,765,359 B2
- Document ID: US10765359B2
- Status: Granted
- Kind: B2
- Application number: 15/381,815
- Filed: 2016-12-16
- Published: 2018-06-21
- Granted: 2020-09-08
- Earliest claimed: 2016-12-16
- Assignees: Medtronic, Inc.
- Applicants: Medtronic, Inc.
- Inventors: Yong K. Cho; Shantanu Sarkar; Eduardo N. Warman
- Web page: https://patentgrep.com/patent/US10765359B2

## CPC

- A61B 5/4818: {Sleep apnoea}
- A61B 5/349: Detecting specific parameters of the electrocardiograph cycle
- A61B 5/352: Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
- A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)}
- A61B 5/7282: {Event detection, e.g. detecting unique waveforms indicative of a medical condition (cough events A61B5/0823; seizures A61B5/4094; sleep apnoea A61B5/4818)}
- A61B 5/746: {Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms}
- A61B 5/0031: {Implanted circuitry}
- A61B 5/07: Endoradiosondes
- A61B 5/287: Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61N 1/3702: {Physiological parameters (A61N1/365 takes precedence; evoked response A61N1/371)}
- A61N 1/3925: {Monitoring; Protecting}
- A61N 1/3956: {Implantable devices for applying electric shocks to the heart, e.g. for cardioversion}
- 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

Sensing circuitry of an implantable medical device (IMD) system may sense a cardiac signal that varies according to a cardiac cycle of a patient. Processing circuitry of the IMD system may determine a series of consecutive cardiac cycle length metric values based on the sensed cardiac signal, identify a plurality of pairs of the cardiac cycle length metrics, each of the pairs of cardiac cycle length metrics separated by an integer ‘n’ of the cardiac cycle length metrics, and construct a distribution of the pairs of cardiac cycle length metrics based on values of the cardiac cycle length metrics for each of the pairs. The processing circuitry may detect a sleep apnea episode of the patient based on one or more characteristics of the constructed distribution, and control communication circuitry of the IMD system to transmit an indication of the detected sleep apnea episode to the external computing device.

## Claims

### Claim 1

An implantable medical device (IMD) system comprising:
communication circuitry configured to communicate with an external computing device;
sensing circuitry configured to sense a cardiac signal that varies as a function of a cardiac cycle of a patient; and
processing circuitry configured to:
determine a series of consecutive cardiac cycle length metric values based on the sensed cardiac signal;
identify a plurality of pairs of the cardiac cycle length metrics, each of the pairs of cardiac cycle length metrics separated by an integer ‘n’ of the cardiac cycle length metrics;
construct a distribution of the pairs of cardiac cycle length metrics based on values of the cardiac cycle length metrics for each of the pairs;
detect a sleep apnea episode of the patient based on dispersion information of the constructed distribution; and
transmit, via the communication circuitry, an indication of the detected sleep apnea episode to the external computing device.

### Claim 2 (depends on 1)

The IMD system of claim 1, wherein the processing circuitry is further configured to determine the dispersion information based on one or more clustering characteristics associated with the constructed distribution.

### Claim 3 (depends on 2)

The IMD of claim 2, wherein the processing circuitry is configured to:
compare the clustering characteristics to a threshold; and
detect the sleep apnea condition based on the comparison.

### Claim 4 (depends on 2)

The IMD of claim 2, wherein the processing circuitry is configured to transmit, via the communication circuitry, a communication to trigger deliver therapy to the patient to remediate one or more effects of the detected sleep apnea event.

### Claim 5 (depends on 4)

The IMD of claim 4, wherein the therapy comprises one or more of a continuous positive airway pressure (CPAP) therapy, a bilevel positive airway pressure (BiPAP) therapy, or a cardiac pacing therapy.

### Claim 6 (depends on 1)

The IMD system of claim 1, wherein each cardiac cycle length metric value of the series of consecutive cardiac cycle length metric values comprises a value of one of a series of consecutive cardiac cycle lengths.

### Claim 7 (depends on 1)

The IMD system of claim 1, wherein each cardiac cycle length metric value of the series of consecutive cardiac cycle length metric values comprises a difference between values of two consecutive cardiac cycle lengths of a series of consecutive cardiac cycle lengths.

### Claim 8 (depends on 1)

The IMD system of claim 1, wherein the processing circuitry is configured to detect the sleep apnea episode based on the dispersion information indicating a degree of dispersion above a threshold level of dispersion.

### Claim 9 (depends on 1)

The IMD system of claim 1, wherein the degree of dispersion comprises a degree of dispersion of the plurality of pairs from a unity line.

### Claim 10 (depends on 1)

The IMD of claim 1, further comprising:
a housing configured for subcutaneous implantation, wherein the housing houses the sensing circuitry; and
a plurality of electrodes coupled to the housing and to the sensing circuitry,
wherein the sensing circuitry is configured to sense the cardiac signal via one or more electrodes of the plurality of electrodes.

### Claim 11

A method of detecting sleep apnea by an implantable medical device (IMD) system, the method comprising:
sensing, by sensing circuitry of the IMD system, a cardiac signal that varies as a function of a cardiac cycle of a patient;
determining, by processing circuitry of the IMD system, a series of consecutive cardiac cycle length metric values based on the sensed cardiac signal;
identifying, by the processing circuitry of the IMD system, a plurality of pairs of the cardiac cycle length metrics, each of the pairs of cardiac cycle length metrics separated by an integer ‘n’ of the cardiac cycle length metrics;
constructing, by the processing circuitry of the IMD system, a distribution of the pairs of cardiac cycle length metrics based on values of the cardiac cycle length metrics for each of the pairs;
detecting, by the processing circuitry of the IMD system, a sleep apnea episode of the patient based on dispersion information of the constructed distribution; and
transmitting, by the processing circuitry of the IMD system, via communication circuitry of the IMD system, an indication of the detected sleep apnea episode to an external computing device.

### Claim 12 (depends on 11)

The method of claim 11, further comprising determining, by the processing circuitry of the IMD system, the dispersion information based on one or more clustering characteristics associated with the constructed distribution.

### Claim 13 (depends on 12)

The method of claim 12, further comprising:
comparing, by the processing circuitry of the IMD system, the clustering characteristics to a threshold; and
detecting, by the processing circuitry of the IMD system, the sleep apnea condition based on the comparison.

### Claim 14 (depends on 12)

The method of claim 12, further comprising detecting, by the processing circuitry of the IMD system, the clustering characteristics at least in part by:
determining, by the processing circuitry of the IMD system, one or more bins using the plurality of pairs of the cardiac cycle length metrics; and
determining, by the processing circuitry of the IMD system, a number of pairs in each bin of the one or more bins.

### Claim 15 (depends on 11)

The method of claim 11, wherein each cardiac cycle length metric value of the series of consecutive cardiac cycle length metric values comprises a value of one of a series of consecutive cardiac cycle lengths.

### Claim 16 (depends on 11)

The method of claim 11, wherein each cardiac cycle length metric value of the series of consecutive cardiac cycle length metric values comprises a difference between values of two consecutive cardiac cycle lengths of a series of consecutive cardiac cycle lengths.

### Claim 17 (depends on 11)

The method of claim 11, wherein detecting the sleep apnea episode based on the determined dispersion information comprises detecting, by the processing circuitry of the IMD system, the sleep apnea episode based on the dispersion information indicating a degree of dispersion above a threshold level of dispersion.

### Claim 18 (depends on 11)

The method of claim 11, wherein the degree of dispersion comprises a degree of dispersion of a plotting of the plurality of pairs from a unity line.

### Claim 19

An implantable medical device (IMD) system comprising:
means for sensing a cardiac signal that varies as a function of a cardiac cycle of a patient;
means for determining a series of consecutive cardiac cycle length metric values based on the sensed cardiac signal;
means for identifying a plurality of pairs of the cardiac cycle length metrics, each of the pairs of cardiac cycle length metrics separated by an integer ‘n’ of the cardiac cycle length metrics;
means for constructing a distribution of the pairs of cardiac cycle length metrics based on values of the cardiac cycle length metrics for each of the pairs; and
means for detecting a sleep apnea episode of the patient based on dispersion information of the constructed distribution;
means for generating an indication of the detected sleep apnea episode; and
means for transmitting the indication of the detected sleep apnea episode to an external computing device.

### Claim 20

A non-transitory computer-readable storage medium encoded with instructions that, when executed, cause processing circuitry of an implantable medical device (IMD) system to:
sense a cardiac signal that varies as a function of a cardiac cycle of a patient;
determine a series of consecutive cardiac cycle length metric values based on the sensed cardiac signal;
identify a plurality of pairs of the cardiac cycle length metrics, each of the pairs of cardiac cycle length metrics separated by an integer ‘n’ of the cardiac cycle length metrics;
construct a distribution of the pairs of cardiac cycle length metrics based on values of the cardiac cycle length metrics for each of the pairs; and
detect a sleep apnea episode of the patient based on dispersion information of the constructed distribution; and
generate an indication of the detected sleep apnea episode; and
transmit the indication of the detected sleep apnea episode to an external computing device.
