Sensors and methods for determining respiration

Patent metadata

Field	Value
Publication number	US-12263342-B2
Application number	US-202117519211-A
Country	US
Kind code	B2
Filing date	Nov 4, 2021
Priority date	Nov 4, 2020
Publication date	Apr 1, 2025
Grant date	Apr 1, 2025

Abstract

The disclosure provides systems and methods for treating obstructive sleep apnea using an inertial measurement unit (IMU) comprising an accelerometer and a gyroscope, wherein the IMU is configured to detect chest and/or abdominal movement by a patient during the inspiration and expiration stages of a respiratory cycle and to generate positional data based on the detected movement. Positional data generated by the IMU is used by an implanted stimulation system to determine when to deliver electrical stimulation to a nerve which innervates an upper airway muscle, such as the hypoglossal nerve, to treat sleep apnea.

First claim

What is claimed is:

1. A system for treating obstructive sleep apnea, comprising:
an inertial measurement unit (IMU) comprising an accelerometer and a gyroscope, wherein the IMU is configured to detect chest and/or abdominal movement by a patient during the inspiration and expiration stages of a respiratory cycle, and to generate chest and/or abdominal positional data based on the detected movement; and
a stimulator comprising:
a stimulation system configured to deliver stimulation to a nerve which innervates an upper airway muscle; and
a controller coupled to the stimulation system, and to the IMU;
wherein the controller is
configured to determine a respiratory cycle of the patient by a) filtering the chest and/or abdominal positional data, and b) performing a principal component analysis (PCA) on the filtered chest and/or abdominal positional data, wherein the PCA comprises use of a covariance matrix generated using a rolling or stepped window of at least 4 seconds; and
configured to cause the stimulation system to stimulate the nerve based on the respiratory cycle of the patient.

2. The system of claim 1 , wherein the accelerometer comprises a 3-axis accelerometer and/or the gyroscope comprises a 3-axis gyroscope.

3. The system of claim 1 , wherein the positional data comprises movement of the chest and/or abdomen of the patient over time.

4. The system of claim 1 , wherein the system further comprises a microphone and/or an electrocardiogram (ECG) sensor coupled to the controller.

5. The system of claim 1 , wherein the controller is configured to determine an apnea-hypopnea index (AHI) based on (a) the positional data and (b) an audio signal detected by the microphone or a heart rate signal detected by the ECG sensor.

6. The system of claim 1 , wherein the controller is further configured to cause the stimulation system to stimulate the nerve based on an audio signal detected by the microphone.

7. The system of claim 4 , wherein the controller is further configured to cause the stimulation system to stimulate the nerve based on a heart rate signal detected by the ECG sensor.

8. The system of claim 1 , wherein the system is configured to filter chest and/or abdominal positional data detected by the IMU using at least one low-pass filter (LPF), high-pass filter (HPF), or band-pass filter (BPF).

9. The system of claim 1 , wherein the system is configured to filter chest and/or abdominal positional data detected by the IMU using a filter that has an upper cut-off frequency of 0.45 to 2 Hz.

10. The system of claim 1 , wherein the system is configured to filter chest and/or abdominal positional data detected by the IMU using a filter that has a high-pass cut-off frequency of 0.05 to 0.1 Hz.

11. The system of claim 1 , wherein the PCA comprises:
a) receiving a signal comprising 3D chest and/or abdominal positional data from the accelerometer component of the IMU, wherein the accelerometer comprises a 3-axis accelerometer and/or a 3D gyroscope;
b) processing the signal using at least one filter;
c) generating a covariance matrix based on the processed signal;
d) computing eigenvectors and eigenvalues for the covariance matrix; and
e) constructing a projection matrix that transforms the 3D chest and/or abdominal positional data into a single dimension.

12. The system of claim 1 , wherein the controller is configured to determine a signal-to-noise ratio (SNR) of the positional data.

13. The system of claim 12 , wherein the controller is configured to operate in an asynchronous mode when the SNR of the positional data falls below a predetermined threshold.

14. The system of claim 13 , wherein the asynchronous mode comprises a mode wherein the controller is configured to cause the stimulation system to stimulate the nerve throughout a full respiration cycle, wherein the start of the respiratory cycle is predicted based on previously logged respiratory rate data.

15. The system of claim 13 , wherein the asynchronous mode comprises a mode wherein the controller is configured to cause the stimulation system to stimulate the nerve:
a) for at least, exactly, or approximately 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5, or 15 seconds;
b) for X-Y seconds, where “X” and “Y” are each independently selected from 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5, or 15;
c) for at least one full respiration cycle, wherein the start of the respiratory cycle is predicted based on previously logged respiratory rate data, and then optionally to cease stimulation for an equal amount of time; or
d) for at least one full respiration cycle, wherein the start of the respiratory cycle is predicted based on previously logged respiratory rate data, and then optionally to cease stimulation for at least, exactly, or approximately 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5, or 15 seconds.

16. The system of claim 12 , wherein the SNR is determined using historical positional data for the patient stored in a log.

17. The system of claim 12 , wherein the SNR is determined based upon
a) at least two out of the three axes of the accelerometer; and/or
b) at least two out of the three axes of the gyroscope.

18. The system of claim 17 , wherein the accelerometer is a 3-axis accelerometer and the controller is configured to determine whether the SNR of at least two out of the three axes of the accelerometer are above a predetermined threshold and to use the strongest component signal to determine the respiratory cycle of the patient.

19. The system of claim 17 , wherein the gyroscope is a 3-axis gyroscope and the controller is configured to determine whether the SNR of at least two out of the three axes of the gyroscope are above a predetermined threshold and to use the strongest component signal to determine the respiratory cycle of the patient.

20. The system of claim 17 , wherein the accelerometer is a 3-axis accelerometer and the controller is configured to determine a body orientation of the patient.

21. The system of claim 20 , wherein the controller is configured to determine whether the patient is asleep based on the body orientation.

22. A method of treating obstructive sleep apnea in a patient comprising:
detecting chest and/or abdominal movement by the patient during the inspiration and expiration stages of a respiratory cycle using an inertial measurement unit (IMU) comprising an accelerometer and/or a gyroscope;
generating, by the IMU, chest and/or abdominal positional data based upon the detected movement, wherein the chest and/or abdominal positional data comprises information describing movement of the chest and/or abdomen of the patient, and optionally the patient's orientation;
determining, by a controller coupled to the IMU, a respiratory waveform corresponding to a respiratory cycle of the patient, using the chest and/or abdominal positional data; and
stimulating a nerve innervating an upper airway muscle of the patient based on the respiratory waveform;
wherein the controller is configured to determine the respiratory waveform by: a) filtering the chest and/or abdominal positional data generated by the IMU, and b) performing a principal component analysis (PCA) on the filtered chest and/or abdominal positional data, wherein the PCA comprises use of a cov

Assignees

• The Alfred E Mann Foundation For Scient Research

Inventors

• Elyahoodayan Sahar
• Shelton Brian M
• Talbot Neil H

Classifications

• A61N1/36135

  using physiological parameters · CPC title

• A61N1/36139

  with automatic adjustment · CPC title

• A61N1/37247

  User interfaces, e.g. input or presentation means · CPC title

• A61N1/37264

  Changing the program; Upgrading firmware · CPC title

• A61N1/0556

  Cuff electrodes · CPC title