METHOD OF TREATING SLEEP DISORDERED BREATHING

• US 20150190089A1
• Filed: 01/15/2015
• Published: 07/09/2015
• Est. Priority Date: 11/19/2008
• Status: Abandoned Application

• Current Assignee: Inspire Medical Systems, Inc.
• Original Assignee: Inspire Medical Systems, Inc.
• Inventors: Christopherson, Mark A., Ni, Quan, Herbert, Timothy P., Rondoni, John
• Application Number:
  US14/597,422
• Publication Number:
  US 20150190089A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/0214 Capacitive electrodes
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/0803 Recording apparatus specially adapted therefor
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3615 : Intensity
• CPC Class Codes: A61N 1/36185 : Selection of the electrode configuration

Abstract

A system and method for automatically implementing a therapy for treating sleep disordered breathing.

Claims

1. A method of identifying a sleep disordered breathing event, comprising:

sensing a bio-impedance signal of a patient;

sensing a respiratory pressure signal of the patient; and

identifying a sleep disordered breathing event via identifying a substantial change in an amplitude of the sensed bio-impedance signal that occurs at substantially the same time as a substantial change in an amplitude of the sensed respiratory pressure signal.

2. The method of claim 1, wherein the sleep disordered breathing event is an obstructive sleep apnea event, and the substantial change in the amplitude of the sensed bio-impedance signal includes a substantial decrease in the amplitude of the sensed bio-impedance signal and wherein the substantial change in the amplitude of the sensed respiratory pressure signal includes a substantial increase in the amplitude of the sensed respiratory pressure signal.

3. The method of claim 1, wherein the sleep disordered breathing event is a central sleep apnea event, and the substantial change in the amplitude of the sensed bio-impedance signal includes a substantial decrease in the amplitude of the sensed bio-impedance signal and wherein the substantial change in the amplitude of the sensed respiratory pressure signal includes a substantial decrease in the amplitude of the sensed respiratory pressure signal.

4. The method of claim 1, wherein the sleep disordered breathing event is a hypopnea event, and the substantial change in the amplitude of the sensed bio-impedance signal includes a substantial decrease in the amplitude of the sensed bio-impedance signal and wherein the substantial change in the amplitude of the sensed respiratory pressure signal includes a substantial increase in the amplitude of the sensed respiratory pressure signal, wherein the respective substantial decrease and the respective substantial increase are of a lower magnitude change than in an obstructive sleep apnea.

5. The method of claim 1, comprising:

implanting a first nerve electrode about a first respiratory-related nerve on a first side of the body and implanting a second nerve electrode about a second respiratory-related nerve on a second side of the body; and

performing sensing of the bio-impedance signal via sensing the bio-impedance signal between the first nerve electrode on the first side of the body and the second nerve electrode on the second side of the body.

6. The method of claim 1, comprising:

performing sensing of the bio-impedance signal as sensing a trans-thoracic bio-impedance signal.

7. The method of claim 3, comprising:

identifying the substantial change in the amplitude of the sensed bio-impedance signal relative to a baseline cyclic amplitude of the sensed bio-impedance signal during non-disordered breathing; and

identifying the substantial change in the amplitude of the sensed respiratory pressure signal relative to determining a baseline cyclic amplitude of the sensed respiratory pressure signal during non-disordered breathing.

8. The method of claim 7, comprising:

identifying the substantial change when a percentage change in the amplitude of the sensed bio-impedance signal, relative to the baseline cyclic amplitude of the sensed bio-impedance signal, has a greater magnitude than a threshold percentage change.

9. The method of claim 8, wherein the threshold percentage change is at least 50%.

10. The method of claim 8, comprising:

identifying the substantial change when a percentage change in the amplitude of the sensed respiratory pressure signal, relative to the baseline cyclic amplitude of the sensed respiratory pressure signal, has a greater magnitude than a threshold percentage change.

11. The method of claim 10, comprising:

computing an average of the percentage change in the amplitude of the sensed respiratory pressure signal and of the percentage change in the amplitude of the sensed trans-thoracic bio-impedance signal; and

identifying the sleep disordered breathing event based on the average exceeding a threshold average percentage change.

12. The method of claim 1, comprising:

confirming the sleep disordered breathing event via detecting a decreasing heart rate that generally coincides with initiation of the sleep disordered breathing event and an increasing heart rate that generally coincides with termination of the sleep disordered breathing event and with a post-sleep disordered breathing period.

13. The method of claim 1, comprising:

confirming the sleep disordered breathing event via detecting a substantial decrease in a blood oxygen saturation of the patient that generally coincides with the sleep disordered breathing event and a post-sleep disordered breathing period.

14. The method of claim 1, comprising:

determining at least one of a duration or a severity of the sleep disordered breathing event based on at least one of;

detecting a decreasing heart rate that generally coincides with initiation of the sleep disordered breathing event and an increasing heart rate that generally coincides with termination of the sleep disordered breathing event and with a post-sleep disordered breathing period; and

detecting a substantial decrease in a blood oxygen saturation of the patient that generally coincides with the sleep disordered breathing event and a post-sleep disordered breathing period.

15. The method of claim 1, comprising:

identifying a hyperventilation period following the sleep disordered breathing event via identifying a substantial increase in the amplitude of the sensed bio-impedance signal after the sleep disordered breathing event that occurs at substantially the same time as a substantial increase in an amplitude of the sensed respiratory pressure signal after the sleep disordered breathing event.

16. The method of claim 15, comprising:

identifying, based on a duration of the hyperventilation period, a severity of the sleep disordered breathing event preceding the hyperventilation period.

17. A system for identifying a sleep disordered breathing event in a patient, comprising:

a bio-impedance sensor configured to detect a bio-impedance signal in the patient;

a respiratory pressure sensor configured to detect a respiratory pressure signal in the patient; and

a monitor configured to detect a sleep disordered breathing event via identifying a substantial change in an amplitude of the sensed bio-impedance signal that occurs at substantially the same time as a substantial change in an amplitude of the sensed respiratory pressure signal.

18. The system of claim 17, wherein the sleep disordered breathing event comprises at least one of an obstructive sleep apnea event, a hypopnea event, or a central sleep apnea event.

19. The system of claim 17, wherein the bio-impedance sensor, the respiratory pressure sensor, and the signal monitor are all implantable in the patient.

20. The system of claim 17, wherein the bio-impedance sensor comprises a combination of:

a first nerve electrode configured to be coupled to a first airway patency-related nerve on a first side of the body; and

a second nerve electrode configured to be coupled to a second airway patency-related nerve on a second side of the body opposite the first side,

wherein the monitor and the sensor are configured, in cooperation with each other, to measure the bio-impedance between the first nerve electrode and the second nerve electrode.