Device and method for manipulating exhalation

• US 9,259,573 B2
• Filed: 11/10/2005
• Issued: 02/16/2016
• 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): Koharski, Christopher D
• Assistant Examiner(s): D ABREU, MICHAEL JOSEPH
• Application Number:
  US11/271,554
• Publication Number:
  US 20060122662A1
• Time in Patent Office: 3,750 Days
• Field of Search: 607/42, 600/529, 600/532
• US Class Current: 1/1
• 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 1/3601 of respiratory organs

Abstract

A device and method is provided for increasing the functional residual capacity of lungs of a subject by electrically stimulating tissue associated with the diaphragm or phrenic nerve of the subject.

Claims

1. A method of treating a sleep breathing disorder in a subject comprising:

providing an electrical stimulator;

determining one or more respiratory parameters obtained from sensing respiration and identifying a portion of a respiratory cycle; and

electrically stimulating a diaphragm or phrenic nerve tissue of the subject to directly control diaphragm muscle contractions by applying electrical stimulation within the exhalation cycle to maintain the diaphragm contracted relative to a non-stimulated diaphragm during the exhalation cycle such that residual air is held in the lungs where the residual air is increased beyond a volume present in the lungs of a non-stimulated exhalation, and wherein the electrical stimulation is adjusted in response to the one or more respiratory parameters.

2. The method of claim 1 wherein the step electrically stimulating comprises stimulating during intrinsic breathing to control the duration of exhalation.

3. The method of claim 2 wherein the step of controlling the duration of exhalation comprises increasing the duration of exhalation.

4. The method of claim 1 wherein the step of controlling exhalation by electrical stimulation to control diaphragm contractions comprises electrically stimulating to preserve lung volume for a period of time during exhalation.

5. The method of claim 4 wherein the step of electrically stimulating to preserve lung volume for a period of time comprises electrically stimulating to prevent full exhalation of lung volume in a respiration cycle.

6. The method of claim 1 wherein the step of providing electrical stimulation to thereby manipulate exhalation comprises stimulating during intrinsic breathing to slow the rate of exhalation.

7. The method of claim 1 wherein the step of electrically stimulating comprises electrically stimulating at an end portion of inspiration to slow an exhalation rate.

8. The method of claim 1 wherein the step of electrically stimulating comprises electrically stimulating during exhalation to slow an exhalation rate.

9. The method of claim 1 wherein the step of electrically stimulating comprises decreasing respiration rate.

10. The method of claim 1 wherein the step of electrically stimulating comprises stimulating transvenously.

11. The method of claim 1 wherein the step of electrically stimulating comprises manipulating the at least one parameter to increase a lung volume by trapping air within at least one lung.

12. The method of claim 1 wherein the step of electrically stimulating comprises manipulating the at least one parameter to bias or still the diaphragm and/or at least one lung.

13. The method of claim 1 wherein treating a sleep breathing disorder comprises treating central apnea.

14. The method of claim 1 wherein treating a sleep breathing disorder comprises treating obstructive apnea.

15. The method of claim 1 wherein treating a sleep breathing disorder comprises treating a Cheyne-Stoke pattern of periodic breathing comprising at least a Cheyne-Stoke respiration.

16. A method for treating a breathing disorder comprising:

determining one or more respiratory parameters obtained from sensing respiration identifying a portion of a respiratory cycle;

applying electrical stimulation to diaphragm or phrenic nerve tissue which directly affects a respiratory response of a subject; and

,

directly manipulating exhalation by controlling the electrical stimulation to the tissue such that the electrical stimulation is applied within the exhalation cycle to maintain the diaphragm contracted relative to a non-stimulated diaphragm during the exhalation cycle such that residual air is held in the lungs to treat a breathing disorder where the residual air is increased beyond a volume present in the lungs of a non-stimulated exhalation, and where the electrical stimulation for controlling exhalation is adjusted in response to the one or more respiratory parameters.

17. The method of claim 16 wherein the step of manipulating exhalation comprises manipulating exhalation duration.

18. The method of claim 17 wherein the step of manipulating exhalation duration comprises shortening an expiration period to control oxygen levels in the blood.

19. The method of claim 17 wherein the step of manipulating exhalation duration comprises shortening an expiration period to control carbon dioxide levels in the blood.

20. The method of claim 16 wherein the step of manipulating exhalation comprises manipulating rate of exhalation.

21. The method of claim 20 wherein the rate of exhalation is manipulated to increase the rate of exhalation.

22. The method of claim 16 wherein the step of manipulating exhalation comprises manipulating exhalation amplitude to control oxygen and carbon dioxide levels in the blood.

23. The method of claim 16 wherein treating a breathing, disorder comprises treating central apnea.

24. The method of claim 16 wherein treating a breathing disorder comprises treating obstructive apnea.

25. The method of claim 16 wherein the step of controlling stimulation comprises providing stimulation transvenously.

26. The method of claim 16 wherein treating a breathing disorder comprises treating a Cheyne-Stoke pattern of periodic breathing comprising at least a Cheyne-Stoke respiration.

27. The method of claim 16 wherein the step of manipulating exhalation comprises increasing a lung volume by trapping air within at least one lung.

28. The method of claim 16 wherein the step of manipulating exhalation comprises biasing or stilling the diaphragm and/or at least one lung.

29. A respiration control device for treating a subject comprising:

an electrical stimulator comprising a stimulation protocol programmed to deliver an electrically stimulating signal to phrenic nerve or diaphragm tissue of a subject to activate diaphragm contraction of the subject, wherein the stimulator is programmed to apply the stimulating signal within the exhalation cycle to maintain the diaphragm contracted relative to a non-stimulated diaphragm during the exhalation cycle such that residual air is held in the lungs where the residual air is increased beyond a volume present in the lung of a non-stimulated exhalation; and

,

a sensor in communication with the stimulator and which is configured to sense respiratory information whereby the electrical stimulator receives the respiration information via the sensor.

30. The device of claim 29 further comprising a stimulation timer configured to initiate stimulation at selected portion of an intrinsic respiration cycle wherein said stimulation is configured to preserve lung volume for a period of time during exhalation.

31. The device of claim 30 wherein the stimulation timer is configured to initiate stimulation during a portion of inspiration.

32. The device of claim 30 wherein the stimulation timer is configured to initiate stimulation during a portion of exhalation.

33. The device of claim 30 wherein the stimulation timer is configured to stimulate to prevent full exhalation during a respiration cycle.

34. The device of claim 30 wherein the stimulation timer is configured to control stimulation to decrease respiration rate.

35. The device of claim 29 further comprising a stimulation timer configured to initiate stimulation at selected portion of an intrinsic respiration cycle wherein said stimulation is configured to control the duration of exhalation.

36. The device of claim 29 wherein the stimulation is configured to increase exhalation duration.

37. The device of claim 29 further comprising a stimulation timer configured to initiate stimulation at selected portion of an intrinsic respiration cycle wherein said stimulation is configured to slow the rate of exhalation.

38. The device of claim 29 wherein the electrical stimulator comprises a transvenous electrode.

39. The device of claim 29 wherein the stimulation is configured to increase a lung volume by trapping air within at least one lung.

40. The device of claim 29 wherein the stimulation is configured to bias or still the diaphragm and at least one lung.