# US 11,992,306 B2 · Temperature monitoring for sleep disordered breathing

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- Number: US 11,992,306 B2
- Document ID: US11992306B2
- Status: Granted
- Kind: B2
- Application number: 17/486,521
- Filed: 2021-09-27
- Published: 2022-03-31
- Granted: 2024-05-28
- Earliest claimed: 2020-09-30
- Assignees: Cardiac Pacemakers, Inc.
- Applicants: Cardiac Pacemakers, Inc.
- Inventors: Gezheng Wen; Pramodsingh Hirasingh Thakur; John D. Hatlestad; Qi An
- Web page: https://patentgrep.com/patent/US11992306B2

## CPC

- A61B 5/0826: {Detecting or evaluating apnoea events (sleep apnoea A61B5/4818)}
- A61B 5/01: Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20)
- A61B 5/085: Measuring impedance of respiratory organs or lung elasticity
- A61B 5/091: Measuring volume of inspired or expired gases, e.g. to determine lung capacity
- A61B 5/4806: {Sleep evaluation (A61B5/4821 takes precedence; devices for inducing sleep A61M21/02)}
- A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)}
- A61B 5/746: {Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms}
- A61B 2562/0271: Thermal or temperature sensors
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Systems and methods to are disclosed to determine a sleep disordered breathing parameter of a patient, including receiving respiration information of the patient and temperature information of the patient and to determine the sleep disordered breathing parameter of the patient using the received respiration information and temperature information of the patient.

## Claims

### Claim 1

An implantable cardiac monitor, comprising:
a respiration sensor configured to sense respiration information of a patient;
a temperature sensor configured to sense temperature information of a housing of the implantable cardiac monitor; and
an assessment circuit configured to determine distal skin temperature of the patient using the sensed temperature information and to determine a sleep disordered breathing parameter of the patient using the sensed respiration information of the patient and the determined distal skin temperature of the patient.

### Claim 2 (depends on 1)

The implantable cardiac monitor of claim 1, wherein the respiration sensor includes an impedance sensor configured to sense an impedance of the thorax of the patient and to determine respiration information of the patient using changes in the sensed impedance associated with patient respiration,
wherein the determined respiration information includes a determined tidal volume measure of the patient, and
wherein the assessment circuit is configured to determine the sleep disordered breathing parameter using a detected decrease in the determined tidal volume measure of the patient greater than a sleep disordered breathing threshold from a baseline tidal volume measure over a detection window.

### Claim 3 (depends on 2)

The implantable cardiac monitor of claim 2, wherein
the assessment circuit is configured to determine the sleep disordered breathing parameter using a combination of determined tidal volume measure of the patient over the detection window and the determined patient distal skin temperature corresponding to the detection window.

### Claim 4 (depends on 3)

The implantable cardiac monitor of claim 3, wherein the assessment circuit is configured to determine the sleep disordered breathing parameter using the detected decrease in the determined tidal volume measure of the patient greater than the sleep disordered breathing threshold and the determined patient distal skin temperature greater than a temperature threshold,
wherein the sleep disordered breathing parameter includes an indication that a sleep disordered breathing event has occurred over the detection window, and
wherein the assessment circuit is configured to determine the baseline tidal volume measure using the determined tidal volume measure of the patient over a baseline period longer than the detection window and preceding the detection window.

### Claim 5 (depends on 4)

The implantable cardiac monitor of claim 4, wherein the detection window has a period between 5 and 15 seconds, and wherein the baseline period is a minute or longer.

### Claim 6 (depends on 4)

The implantable cardiac monitor of claim 4, wherein the assessment circuit is configured to count a number of sleep disordered breathing events in a daily period, and
wherein the assessment circuit is configured to adjust at least one of the sleep disordered breathing threshold or the length of the detection window using the sensed temperature information.

### Claim 7 (depends on 3)

The implantable cardiac monitor of claim 3, wherein the assessment circuit is configured to determine the temperature threshold using a rate of change of the sensed temperature information.

### Claim 8 (depends on 2)

The implantable cardiac monitor of claim 2, wherein the assessment circuit is configured to:
determine an initial sleep disordered breathing parameter of the patient using the sensed respiration information; and
determine a confidence indication of the determined initial sleep disordered breathing parameter using the sensed temperature information.

### Claim 9 (depends on 8)

The implantable cardiac monitor of claim 8, wherein the confidence indication includes indications of high confidence and low confidence, and
wherein the assessment circuit is configured to:
determine an indication of high confidence if the sensed temperature information corresponding to the determined initial sleep disordered breathing parameter is at or above a threshold; and
determine an indication of low confidence if the sensed temperature information corresponding to the determined initial sleep disordered breathing parameter is below the threshold.

### Claim 10

A medical device system, comprising:
a signal receiver circuit configured to receive respiration information of a patient and temperature information of an implantable housing of the medical device system; and
an assessment circuit configured to determine distal skin temperature of the patient using the received temperature information and to determine a sleep disordered breathing parameter of the patient using the received respiration information and the determined distal skin temperature of the patient.

### Claim 11 (depends on 10)

The medical device system of claim 10, wherein the respiration information comprises impedance information of the patient indicative of a tidal volume of the patient, and
wherein the assessment circuit is configured to determine the sleep disordered breathing parameter using a detected decrease in the received impedance information greater than a sleep disordered breathing threshold from a baseline respiration measure over a detection window.

### Claim 12 (depends on 11)

The medical device system of claim 11, wherein
the assessment circuit is configured to determine the sleep disordered breathing parameter using a combination of the received impedance information over the detection window and the temperature of the implantable housing corresponding to the detection window.

### Claim 13 (depends on 12)

The medical device system of claim 12, wherein the assessment circuit is configured to determine the sleep disordered breathing parameter using the detected decrease in the received impedance information indicative of the tidal volume of the patient greater than the sleep disordered breathing threshold and the temperature of the implantable housing greater than a temperature threshold,
wherein the sleep disordered breathing parameter includes an indication that a sleep disordered breathing event has occurred over the detection window, and
wherein the assessment circuit is configured to determine the baseline tidal volume measure using the determined tidal volume measure of the patient over a baseline period longer than the detection window and preceding the detection window.

### Claim 14 (depends on 13)

The medical device system of claim 13, wherein the detection window has a period between 5 and 15 seconds,
wherein the baseline period is a minute or longer,
wherein the assessment circuit is configured to count a number of sleep disordered breathing events in a daily period, and
wherein the assessment circuit is configured to adjust at least one of the sleep disordered breathing threshold or the length of the detection window using the received temperature information.

### Claim 15 (depends on 11)

The medical device system of claim 11, wherein the assessment circuit is configured to:
determine an initial sleep disordered breathing parameter of the patient using the received respiration information; and
determine a confidence indication of the determined initial sleep disordered breathing parameter using the received temperature information.

### Claim 16 (depends on 15)

The medical device system of claim 15, wherein the confidence indication includes indications of high confidence and low confidence, and
wherein the assessment circuit is configured to:
determine an indication of high confidence if the received temperature information corresponding to the determined initial sleep disordered breathing parameter is at or above a threshold; and
determine an indication of low confidence if the received temperature information corresponding to the determined initial sleep disordered breathing parameter is below the threshold.

### Claim 17

A method, comprising:
receiving respiration information of a patient and temperature information of an implantable housing of a medical device system using a signal receiver circuit; and
determining, using an assessment circuit, distal skin temperature of the patient using the received temperature information and a sleep disordered breathing parameter of the patient using a combination of the received respiration information and the determined distal skin temperature of the patient.

### Claim 18 (depends on 17)

The method of claim 17, wherein the respiration information comprises impedance information of the patient indicative of a tidal volume of the patient, and
wherein determining the sleep disordered breathing parameter of the patient comprises using: (1) a detected decrease in the received impedance information greater than a sleep disordered breathing threshold from a baseline respiration measure over a detection window, and (2) the temperature of the implantable housing corresponding to the detection window.

### Claim 19 (depends on 18)

The method of claim 18, wherein determining the sleep disordered breathing parameter includes determining an indication that a sleep disordered breathing event has occurred over the detection window, and
wherein the method comprises:
determining the baseline respiration measure using the respiration information of the patient over a baseline period longer than and preceding the detection window;
counting a number of sleep disordered breathing events of the patient in a daily period; and
adjusting at least one of the sleep disordered breathing threshold or the length of the detection window using the received temperature information,
wherein the detection window has a period between 5 and 15 seconds, and
wherein the baseline period is a minute or longer.

### Claim 20 (depends on 18)

The method of claim 18, wherein determining the sleep disordered breathing parameter comprises:
determining an initial sleep disordered breathing parameter of the patient using the received respiration information; and
determining a confidence indication of the determined initial sleep disordered breathing parameter using the received temperature information.

### Claim 21

An implantable cardiac monitor, comprising:
a respiration sensor configured to sense respiration information of a patient;
a temperature sensor configured to sense temperature information of the patient; and
an assessment circuit configured to determine a sleep disordered breathing parameter of the patient using the sensed respiration information of the patient and the sensed temperature information of the patient,
wherein, to determine the sleep disordered breathing parameter, the assessment circuit is configured to:
determine an initial sleep disordered breathing parameter of the patient using the sensed respiration information; and
determine a confidence indication of the determined initial sleep disordered breathing parameter using the sensed temperature information.

### Claim 22 (depends on 21)

The implantable cardiac monitor of claim 21, wherein the confidence indication includes indications of high confidence and low confidence, and
wherein the assessment circuit is configured to:
determine an indication of high confidence if the sensed temperature information corresponding to the determined initial sleep disordered breathing parameter is at or above a threshold; and
determine an indication of low confidence if the sensed temperature information corresponding to the determined initial sleep disordered breathing parameter is below the threshold.
