Device and method for treating obstructive sleep apnea

• US 20060142815A1
• Filed: 11/10/2005
• Published: 06/29/2006
• Est. Priority Date: 10/15/2003
• Status: Active Grant

• Current Assignee: RMX, LLC (ASHINC Corp.)
• Original Assignee: RMX, LLC (ASHINC Corp.)
• Inventors: Province, Rose, Lee, Chang, Ligon, David, Tehrani, Amir J., Goodman, Amy Michelle
• Granted Patent: US 8,244,358 B2
• Time in Patent Office: Days
• US Class Current: 607/42
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/395 Details of stimulation, e.g. nerve stimulation to elicit EMG response
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61N 1/32 alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02
• CPC Class Codes: A61N 1/3601 of respiratory organs

Abstract

A device and method are provided for treating obstructive respiratory events by electrically stimulating tissue associated with the phrenic nerve or diaphragm to elicit a respiratory response.

Claims

1. A method of treating obstructive sleep apnea in a patient who has been diagnosed with obstructive sleep apnea comprising the steps of;

sensing at least one respiration parameter; and

providing electrical stimulation to tissue associated with the respiratory tract to manipulate the diaphragm to thereby manipulate breathing to mitigate an obstructive respiratory event.

2. The method of claim 1 further comprising the step of coordinating the stimulation with the at least one sensed respiration parameter.

3. The method of claim 1 wherein the step of sensing at least one respiration parameter comprises sensing at least one indicator preceding onset of an obstructive respiratory event.

4. The method of claim 3 wherein the step of sensing at least one indicator comprises sensing a tidal volume correlated signal of a patient below a predetermined threshold.

5. The method of claim 3 wherein the step of sensing at least one indicator comprises sensing erratic breathing characteristic of breathing preceding an obstructive respiratory event.

6. The method of claim 1 wherein the step of coordinating electrical stimulation with the at least one respiration parameter comprises timing the stimulation with respect to said at least one parameter.

7. The method of claim 1 wherein the step of stimulating the tissue associated with the respiratory tract comprises controlling breathing of the patient.

8. The method of claim 7 wherein the step of controlling breathing comprises entraining breathing.

9. The method of claim 7 wherein the step of controlling breathing comprises controlling breathing for a predetermined period.

10. The method of claim 7 wherein the step of controlling breathing comprises increasing tidal volume of a breath with respect to a normal tidal volume.

11. The method of claim 7 wherein the step of controlling breathing comprises manipulating the duration of an inspiration cycle.

12. The method of claim 11 wherein the step of manipulating the duration of an inspiration cycle comprises increasing the duration of an inspiration cycle.

13. The method of claim 7 wherein the step of controlling breathing comprises the step of manipulating an exhalation portion of a respiration cycle.

14. The method of claim 13 wherein the step of manipulating comprises the step of stimulating during the exhalation portion of the respiration cycle.

15. The method of claim 1 wherein the step of electrically stimulating tissue of the respiratory tract comprises stimulating during an inspiration cycle of an intrinsic breath of a patient.

16. The method of claim 15 wherein the step of stimulating during an inspiration cycle further comprises increasing inspiration duration with respect to an intrinsic inspiration duration of an intrinsic breath.

17. The method of claim 16 wherein the step of electrically stimulating tissue of the respiratory tract comprises providing stimulation to normalize tidal volume.

18. The method of claim 1 wherein the step of electrically stimulating comprises providing a low level of stimulation.

19. The method of claim 18 wherein the step of providing a low level of stimulation comprises providing a stimulation signal below a threshold for causing a breath.

20. The method of claim 18 wherein the step of providing a low level of stimulation comprises providing a stimulation signal less than or equal to 8 milliamps.

21. The method of claim 1 wherein the step of electrically stimulating comprises electrically stimulating the phrenic nerve of a patient.

22. The method of claim 1 wherein the step of electrically stimulating comprises electrically stimulating the diaphragm of the patient.

23. The method of claim 22 wherein the step of coordinating the stimulation comprises stimulating during an end portion of an exhalation portion of a respiration cycle.

24. The method of claim 22 wherein the step of coordinating the stimulation comprises synchronizing stimulation with a portion of an intrinsic breath.

25. The method of claim 1 wherein the step of coordinating the stimulation comprises stimulating during at least a portion of a respiration cycle.

26. An obstructive sleep apnea treatment device comprising:

an obstructive respiratory event detector configured to detect at least one respiration parameter associated with a possible occurrence of an obstructive respiratory event; and

an electrical stimulator comprising a controller and at least one implantable electrode, and configured to stimulate tissue associated with the respiratory tract to elicit a diaphragm respiratory response;

wherein the controller comprises a stimulation protocol programmed into the controller; and

a responsive element configured to respond to detection of the at least one respiration parameter, with electrical stimulation according to the protocol.

27. The device of claim 26 wherein the protocol is configured to increase functional residual capacity.

28. The device of claim 26 wherein the protocol is configured to normalize peak flow through an upper air passageway and to increase tidal volume by increasing inspiration duration.

29. The device of claim 26 wherein the protocol comprises:

a protocol configured to stimulate during an inspiration cycle of a patient.

30. The device of claim 26 wherein the protocol comprises an exhalation manipulation protocol configured to manipulate exhalation of at least one respiration cycle.

31. The device of claim 30 wherein the exhalation manipulation protocol comprises a stimulation protocol configured to provide stimulation during an exhalation portion of a respiration cycle.

32. The device of claim 26 wherein the protocol comprises an entrainment protocol configured to control breathing.