Device and method for treating obstructive sleep apnea

• US 8,244,358 B2
• Filed: 11/10/2005
• Issued: 08/14/2012
• Est. Priority Date: 10/15/2003
• Status: Active Grant

• Current Assignee: RMX, LLC (ASHINC Corp.)
• Original Assignee: RMX, LLC (ASHINC Corp.)
• Inventors: Tehrani, Amir J., Ligon, David, Lee, Chang, Province, Rose, Goodman, Amy Michelle
• Primary Examiner(s): Manuel, George
• Assistant Examiner(s): ALTER, ALYSSA MARGO
• Application Number:
  US11/271,315
• Publication Number:
  US 20060142815A1
• Time in Patent Office: 2,469 Days
• Field of Search: 607/42, 607/529, 607/20, 600/529
• 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 an obstructive airway disorder in a patient who has been diagnosed with an obstructive airway disorder comprising the step of:

monitoring an indication of respiratory activity from tissue internally within the patient via at least one electrode;

detecting via a processor for a characteristic indicative of an obstructive respiratory event from the respiratory activity; and

,

upon detection of the characteristic providing electrical stimulation to the diaphragm or phrenic nerve tissue at least to an end of exhalation where a waveform of the stimulating signal for controlling exhalation is adjusted in response to the sensed parameter whereby a supplemental lung volume is preserved to thereby mitigate an obstructive disorder.

2. The method of claim 1 wherein the step of providing stimulation to manipulate the diaphragm comprises providing stimulation during intrinsic breathing.

3. The method of claim 1 wherein the step of stimulating comprises providing stimulation to create a lung volume bias.

4. The method of claim 1 wherein the step of providing stimulation comprises manipulating the diaphragm to increase functional residual capacity.

5. The method of claim 1 wherein the step of providing stimulation comprises manipulating the diaphragm to increase lung volume during at least a portion of an exhalation cycle.

6. The method of claim 1 wherein the step of providing stimulation comprises manipulating the diaphragm to increase lung volume during at least a portion of an end portion of an exhalation cycle.

7. The method of claim 1 wherein the step of providing stimulation comprises manipulating the diaphragm to increase lung volume immediately prior to a subsequent inspiration cycle.

8. The method of claim 1 wherein the step of providing stimulation comprises providing a stimulation signal whereby an intrinsic breath may occur during the stimulation signal.

9. The method of claim 1 wherein the step of providing stimulation comprises manipulating the diaphragm to increase upper airway patency.

10. The method of claim 1 wherein the step of providing stimulation comprises providing a stimulation for a duration greater than the duration of one respiratory cycle.

11. The method of claim 1 wherein the step of manipulating breathing comprises the step of manipulating an exhalation portion of a respiration cycle.

12. The method of claim 11 wherein the step of manipulating an exhalation portion comprises the step of stimulating during the exhalation portion of the respiration cycle.

13. The method of claim 11 wherein the step of providing stimulation comprises providing a stimulation configured to manipulate the duration of an exhalation portion of a respiration cycle.

14. The method of claim 11 wherein the step of providing a stimulation comprises providing a stimulation configured to manipulate a ratio of the duration of an exhalation portion of a respiration cycle with respect to an inspiration portion of the respiration cycle.

15. The method of claim 1 wherein the step of stimulating tissue associated with respiration comprises providing a stimulation configured to manipulate the duration of an inspiration portion of a respiration cycle.

16. The method of claim 15 wherein the step of manipulating the duration of an inspiration cycle comprises increasing the duration of an inspiration cycle.

17. The method of claim 1 wherein the step of stimulating tissue associated with respiration comprises stimulating during an inspiration cycle of an intrinsic breath of a patient.

18. The method of claim 17 wherein the step of stimulating tissue associated with respiration comprises providing stimulation to normalize tidal volume.

19. The method of claim 1 wherein the step of stimulating the tissue associated with respiration comprises controlling breathing of the patient.

20. The method of claim 19 wherein the step of controlling breathing comprises entraining breathing.

21. The method of claim 19 wherein the step of controlling breathing comprises controlling breathing for a predetermined period.

22. The method of claim 19 wherein the step of controlling breathing comprises increasing tidal volume of a breath with respect to a baseline normal tidal volume.

23. A method of claim 1 further comprising:

sensing at least one respiration parameter.

24. The method of claim 23 further comprising the step of coordinating the stimulation with the at least one sensed respiration parameter.

25. The method of claim 24 wherein the step of coordinating the stimulation comprises stimulating during an end portion of an exhalation portion of a respiration cycle.

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

27. The method of claim 24 wherein the step of coordinating the stimulation comprises stimulating during at least a portion of a respiration cycle.

28. The method of claim 23 wherein the step of sensing at least one respiration parameter comprises sensing at least one indicator preceding onset of an obstructive respiratory event.

29. The method of claim 28 wherein the step of sensing a respiration parameter comprises sensing an erratic breathing characteristic.

30. The method of claim 23 wherein the step of sensing at least one indicator comprises sensing a tidal volume correlated signal of a patient below a predetermined threshold.

31. The method of claim 23 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.

32. An obstructive airway disorder treatment device comprising:

an electrical stimulator configured to provide an electrically stimulating signal to diaphragm or phrenic nerve tissue associated with respiration, to elicit a diaphragm response;

a sensor configured to sense at least one respiration parameter in electrical communication with the electrical stimulator;

a processor configured to communicate with the sensor and programmed to coordinate the electrically stimulating signal with the at least one sensed respiration parameter during natural intrinsic respiration by and further programmed to detect for a characteristic indicative of an obstructive respiratory event from the sensed respiration, and,

wherein the processor is also programmed to actuate the electrical stimulator to provide the electrically stimulating signal to the tissue at least to an end of exhalation where a waveform of the stimulating signal for controlling exhalation is adjusted in response to the sensed parameter whereby a supplemental lung volume is preserved.

33. The device of claim 32 wherein the electrical stimulator is configured to provide stimulation to manipulate the diaphragm to increase lung volume during at least a portion of an exhalation cycle.

34. The device of claim 32 wherein the electrical stimulator is configured to manipulate the diaphragm to increase lung volume immediately prior to a subsequent inspiration cycle.

35. The device of claim 32 wherein the electrical stimulator is configured to manipulate the diaphragm whereby an intrinsic breath may occur during the stimulation signal.

36. The device of claim 32 wherein the electrical stimulator is configured to manipulate the diaphragm to thereby increase upper airway patency.

37. The device of claim 32 wherein the electrical stimulator is configured to manipulate the diaphragm for a duration greater than the duration of one respiratory cycle.

38. An obstructive airway disorder treatment device comprising:

an electrical stimulator configured to provide an electrically stimulating signal to diaphragm or phrenic nerve tissue associated with respiration, to elicit a diaphragm response;

a sensor configured to sense at least one respiration parameter in electrical communication with the electrical stimulator;

a processor configured to communicate with the sensor and programmed to coordinate the electrically stimulating signal with the at least one sensed respiration parameter during natural intrinsic respiration by a and further programmed to detect for a characteristic indicative of an obstructive respiratory event from the sensed respiration, and,

wherein the processor is also programmed to actuate the electrical stimulator to provide the electrically stimulating signal to the tissue at least to an end of exhalation where a waveform of the stimulating signal for controlling exhalation is adjusted in response to the sensed parameter whereby a supplemental lung volume is preserved.

39. An obstructive airway disorder treatment device comprising:

an obstructive respiratory disorder detector configured to detect at least one respiration parameter associated with an airway obstruction;

a processor configured to communicate with the detector and is programmed to coordinate an electrical stimulation with the at least one respiration parameter;

an electrical stimulator actuated by the processor and configured to be programmed to stimulate diaphragm or phrenic nerve tissue associated with respiration to elicit a diaphragm response at least to an end of exhalation where a waveform of the stimulating signal for controlling exhalation is adjusted in response to the sensed parameter whereby a supplemental lung volume is preserved, wherein the electrical stimulator is further configured to be programmed with a stimulation protocol; and

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

40. The device of claim 39 wherein the protocol is configured to increase functional residual capacity.

41. The device of claim 39 wherein the protocol is configured to improve upper airway patency.

42. The device of claim 39 wherein the protocol comprises an exhalation manipulation protocol configured to manipulate exhalation to increase gas exchange through the lung.

43. The device of claim 42 wherein the exhalation manipulation protocol comprises a stimulation protocol configured to provide increase lung volume during an exhalation portion of a respiration cycle.

44. The device of claim 39 wherein the protocol comprises an entrainment protocol configured to control breathing.

45. An obstructive airway disorder treatment device comprising:

an electrical stimulator configured to provide an electrically stimulating signal to diaphragm or phrenic nerve tissue associated with respiration, to elicit a diaphragm response to preserve a supplemental lung volume at least to an end of exhalation;

a sensor configured to sense at least one respiration parameter in electrical communication with the electrical stimulator;

a processor configured to communicate with the sensor and programmed to coordinate the electrically stimulating signal with the at least one sensed respiration parameter during natural intrinsic respiration by a and further programmed to detect for a characteristic indicative of an obstructive respiratory event from the sensed respiration, and;

wherein the processor is also programmed to actuate the electrical stimulator to provide the electrically stimulating signal to the tissue at least to an end of exhalation where a waveform of the stimulating signal for controlling exhalation is adjusted in response to the sensed parameter whereby a central respiratory drive is entrained.