Systems for treating obstructive sleep apnea

Patent metadata

Field	Value
Publication number	US-2021290961-A1
Application number	US-202117210033-A
Country	US
Kind code	A1
Filing date	Mar 23, 2021
Priority date	Mar 23, 2020
Publication date	Sep 23, 2021
Grant date	—

Abstract

Systems for treating obstructive sleep apnea having an implanted stimulator with an internal sensor configured to generate sensory data corresponding to movement of the thoracic or abdominal cavity of a patient during respiration. The system includes a wireless communications link between the stimulator and at least one external sensor for sensing a patient's physiological parameter and is used to augment the sensory data from the internal sensor. The stimulator includes a stimulation system configured 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 in a patient comprising:
at least one external sensor configured to sense a physiological parameter of the patient; and a stimulator comprising:
an internal sensor configured to generate a first signal corresponding to movement of the thoracic or abdominal cavity of the patient during respiration;
a stimulation system configured to deliver stimulation to a nerve which innervates an upper airway muscle; and
a controller coupled to the internal sensor and the stimulation system, and wirelessly coupled to the at least one external sensor;
wherein the controller is configured to measure the respiratory cycle of the patient based on the first signal and the sensed physiological parameter, and to cause the stimulation system to stimulate the nerve based on the measured respiratory cycle.

2 . The system of claim 1 wherein the at least one external sensor provides at least one of: peripheral oxygen saturation (SpO 2 ) data, heartrate, heart rate variability, heart rhythm, respiration, electrocardiogram (ECG) data, electroencephalogram (EEG) data, or electrooculogram (EOG) data.

3 . The system of claim 1 , wherein the at least one external sensor comprises at least one of: a wrist wearable watch, a wrist wearable activity tracker, a ring sensor configured to be worn on a finger, a headband, a head cap, a chest band, or a behind the ear sensor.

4 . The system of claim 1 , wherein the system comprises a plurality of external sensors.

5 . The system of claim 1 , wherein the system comprises a plurality of external sensors, each configured to sense a different physiological parameter of the patient.

6 . The system of claim 1 , wherein the stimulator further comprises an auxiliary controller comprising software executed on an external device, wherein the auxiliary controller is wirelessly coupled to the controller, and optionally to the at least one external sensor, and configured to process data received from the controller and/or the at least one external sensor.

7 . The system of claim 6 , wherein the auxiliary controller is configured to process data received from the controller and/or the at least one external sensor by:
determining timing and/or intensity parameters for stimulation based on the received data using at least one machine learning algorithm; and communicating the timing and/or intensity parameters to the controller.

8 . The system of claim 1 wherein the controller is configured to cause the stimulation system to stimulate the nerve during the inspiratory portion of respiration; during the expiratory portion of respiration; or during the inspiratory portion and the expiratory portion of respiration.

9 . The system of claim 1 wherein the stimulator is implantable.

10 . The system of claim 1 wherein the internal sensor is at least one of: an inertial measurement unit or a pressure sensor.

11 . The system of claim 1 wherein the at least one external sensor comprises an inertial sensor, a pressure sensor, an audio sensor, a SpO 2 sensor, or a sensor configured to detect a RIP (Respiratory Inductance Plethysmography) band.

12 . A method of treating obstructive sleep apnea in a patient comprising:
acquiring a first set of sensory data from an implanted sensor corresponding to movement of the thoracic or abdominal cavity of the patient during respiration; acquiring a second set of sensory data via a wireless link from at least one external sensor, the second sensory data corresponding to one or more physiological parameters of the patient; determining a respiratory cycle of the patient based on the first and second sets of sensory data; and stimulating a nerve innervating an upper airway muscle during a stable respiratory cycle following an apneic event, wherein apneic events are determined based on the respiratory cycle of the patient.

13 . The method of claim 12 further comprising identifying an inspiratory portion of the respiratory cycle.

14 . The method of claim 13 wherein stimulating the nerve innervating an upper airway muscle is stimulating the nerve during the inspiratory portion of the respiratory cycle.

15 . The method of claim 12 wherein the at least one external sensor provides at least one of: peripheral oxygen saturation (SpO 2 ) data, heartrate, heart rate variability, heart rhythm, respiration, electrocardiogram (ECG) data, electroencephalogram (EEG) data, or electrooculogram (EOG) data.

16 . The method of claim 12 wherein the at least one external sensor comprises at least one of: a wrist wearable watch, a wrist wearable activity tracker, a ring sensor configured to be worn on a finger, a headband, a head cap, a chest band or a behind the ear sensor.

17 . The method of claim 12 , wherein the internal sensor is at least one of: an inertial measurement unit or a pressure sensor.

18 . The method of claim 12 , wherein the second set of sensory data is acquired from a plurality of external sensors.

19 . The method of claim 18 , wherein each external sensor is configured to detect sensory data corresponding to a different physiological parameter of the patient.

20 . The method of claim 12 , wherein one or more parameters for stimulating the nerve innervating the upper airway muscle are based on the respiratory cycle of the patient.

21 . The method of claim 20 , wherein the parameters comprise a timing and/or an intensity of the stimulation.

22 . The method of claim 12 , further comprising:
determining a sleep state of the patient based on the first and/or second sets of sensory data; wherein one or more parameters for stimulating the nerve innervating the upper airway muscle are based on the sleep state of the patient.

23 . The method of claim 22 , wherein determining the sleep state comprises determining whether the patient is in light sleep, deep sleep, or REM sleep, and the parameters comprise a timing and/or an intensity of the stimulation.

Assignees

• The Alfred E Mann Foundation For Scient Research

Inventors

• Greenberg Robert J
• Suri Harshit R
• Calderon Joseph L
• Dearden Brian R

Classifications

• A61N1/36167

  Timing, e.g. stimulation onset · CPC title

• A61N1/3611

  Respiration control (stimulating respiratory organs A61N1/3601) · CPC title

• A61N1/36139 Primary

  with automatic adjustment · CPC title

• A61N1/37217

  characterised by the communication link, e.g. acoustic or tactile · CPC title

• A61N1/36078

  Inducing or controlling sleep or relaxation (non-implantable stimulator A61M21/00) · CPC title