Device and method to treat flow limitations

• US 8,280,513 B2
• Filed: 12/21/2007
• Issued: 10/02/2012
• Est. Priority Date: 12/22/2006
• Status: Active Grant

• Current Assignee: RMX, LLC (ASHINC Corp.)
• Original Assignee: RMX, LLC (ASHINC Corp.)
• Inventors: Tehrani, Amir J., Province, Rose, Ligon, David
• Primary Examiner(s): STOKLOSA, JOSEPH A
• Application Number:
  US12/004,845
• Publication Number:
  US 20080154330A1
• Time in Patent Office: 1,747 Days
• Field of Search: 607/20, 607/42, 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: A61N 1/3601 of respiratory organs

Abstract

A device and method for detecting and treating airflow limitations in a subject is provided. Levels of flow limited breathing may be differentiated. Obstruction versus flow limited breathing may be differentiated as well. The EMG complex characteristics may be used to detect obstruction or flow limited breathing. The power spectral density plot of the EMG may be used to detect obstruction or flow limited breathing.

Claims

1. A method for treating a subject comprising the steps of:

sensing one or more characteristics of breathing;

detecting flow limited breathing from the sensed one or more characteristics of breathing and recording information relating to the flow limited breathing via polysomnography, wherein detecting flow limited breathing comprises sensing an EMG complex of the subject'"'"'s diaphragm and detecting flow limited breathing from a determination of a parameter corresponding to an area under a power spectral density plot of the EMG complex;

identifying at least one cause of the flow limited breathing based on the recorded information;

correlating the at least one cause to an electrical stimulation protocol programmed to treat the flow limited breathing; and

providing electrical stimulation during an existing respiratory cycle according to the protocol to elicit a diaphragm response to thereby reduce flow limited breathing.

2. The method of claim 1 wherein the step of detecting flow limited breathing from the sensed one or more characteristic of breathing comprises:

detecting a diaphragm EMG having one or more components corresponding to flow limited breathing.

3. The method of claim 2 wherein the step of detecting flow limited breathing from the sensed one or more characteristic of breathing comprises:

detecting a diaphragm EMG complex having a frequency content corresponding to flow limited breathing.

4. The method of claim 2 wherein the step of detecting flow limited breathing from the sensed one or more characteristic of breathing comprises:

detecting a diaphragm EMG envelope having a flattened morphology corresponding to flow limited breathing.

5. The method of claim 2 wherein the step of detecting flow limited breathing from the sensed one or more characteristic of breathing comprises:

detecting a diaphragm EMG complex having an increased width corresponding to flow limited breathing.

6. The method of claim 1 wherein the step of detecting flow limited breathing from at least one EMG parameter comprises:

detecting a diaphragm EMG complex having an increased density of spikes corresponding to flow limited breathing.

7. The method of claim 1 wherein the step of detecting flow limited breathing from at least one EMG parameter comprises:

detecting a diaphragm EMG complex having an increased rising slope corresponding to flow limited breathing.

8. The method of claim 2 wherein the step of detecting flow limited breathing from the sensed one or more characteristic of breathing comprises:

detecting a diaphragm EMG complex having an increased amplitudes of a plurality of corresponding to flow limited breathing.

9. The method of claim 1 wherein the step of providing electrical stimulation according to the protocol to elicit a diaphragm contraction response comprises providing electrical stimulation to increase a baseline lung volume.

10. The method of claim 1 wherein the step of providing electrical stimulation according to the protocol to elicit a diaphragm contraction response comprises providing electrical stimulation to manipulate inspiration duration with respect to duration of a corresponding respiratory cycle.

11. The method of claim 1 wherein the step of providing electrical stimulation according to the protocol to elicit a diaphragm contraction response comprises providing electrical stimulation to inhibit central respiratory drive and to provide therapeutic breathing control.

12. The method of claim 1 wherein the step of providing electrical stimulation according to the protocol to elicit a diaphragm contraction response comprises providing electrical stimulation to manipulate tidal volume.

13. The method of claim 1 further comprising the steps of detecting an imminent disordered event and adjusting the stimulation in response.

14. The method of claim 13 wherein the step of detecting an imminent disordered event comprises detecting a physiological parameter corresponding to a precursor to onset of a disordered event;

and wherein the step of adjusting stimulation comprises providing a stimulation directed to preventing onset of the disordered event.

15. The method of claim 14 wherein the step of providing a stimulation directed to preventing onset of the disordered event comprises providing stimulation to elicit a lung volume bias.

16. The method of claim 1 further comprising the steps of detecting onset of a disordered event and adjusting the stimulation in response.

17. The method of claim 16 wherein the step of detecting onset of a disordered event comprises detecting an airway obstruction;

and wherein the step of adjusting stimulation comprises turning off stimulation.

18. The method of claim 16 wherein the step of detecting onset of a disordered event comprises detecting central apnea;

and wherein the step of adjusting stimulation comprises delivering paced breathing stimulation.

19. The method of claim 1 further comprising setting a detection level for flow limited breathing based on data from the patient.

20. The method of claim 1 further comprising setting a detection level for flow limited breathing based on a degree of flow limitation.

21. The method of claim 1 further comprising setting a detection level for flow limited breathing based on a number of flow limited episodes that are observed in a period of time.

22. The method of claim 1 wherein identifying at least one cause comprises identifying a reduction in a central respiratory drive.

23. The method of claim 22 wherein providing electrical stimulation according to the protocol comprises applying the electrical stimulation to phrenic nerve or diaphragm tissue to supplement or augment at least one breath.

24. The method of claim 1 wherein identifying at least one cause comprises identifying a reduction in lung volume.

25. The method of claim 24 wherein providing electrical stimulation according to the protocol comprises applying the electrical stimulation to phrenic nerve or diaphragm tissue during an exhalation.

26. The method of claim 1 wherein identifying at least one cause comprises identifying an episode of central sleep apnea.

27. The method of claim 26 wherein providing electrical stimulation according to the protocol comprises applying the electrical stimulation to phrenic nerve or diaphragm tissue such that the breathing is paced.

28. The method of claim 1 wherein identifying at least one cause comprises identifying an episode of Cheyne-Stokes.

29. The method of claim 28 wherein providing electrical stimulation according to the protocol comprises applying the electrical stimulation to phrenic nerve or diaphragm tissue to supplement a breath.

30. The method of claim 1 wherein identifying at least one cause comprises identifying an episode of hypopnea.

31. The method of claim 1 wherein identifying at least one cause comprises identifying an episode of obstructive sleep apnea.

32. The method of claim 31 wherein providing electrical stimulation according to the protocol comprises applying the electrical stimulation to phrenic nerve or diaphragm tissue to maintain airway patency.

33. The method of claim 1 wherein the step of correlating the at least one cause to an electrical stimulation protocol further comprises defining a type of the electrical stimulation based upon the information from polysomnography.

34. The method of claim 1 wherein the step of correlating the at least one cause to an electrical stimulation protocol further comprises determining one or more stimulation parameters of the electrical stimulation based upon the information from polysomnography.

35. The method of claim 1 further comprising sensing one or more physiological parameters of the subject.

36. The method of claim 35 where the physiological parameters comprise ECG, heart rate, or heart rate variability.

37. A method for detecting a flow limitation comprising the steps of:

sensing EMG of a subject'"'"'s diaphragm;

detecting a flow limitation from at least one EMG parameter wherein the at least one EMG parameter comprises a frequency content of an EMG complex;

recording the EMG parameter relating to the flow limitation via polysomnography;

identifying at least one cause of the flow limitation based on the recorded EMG parameter from a determination of the EMG parameter corresponding to an area under a power spectral density plot of the EMG complex;

correlating the at least one cause to an electrical stimulation protocol programmed to treat the flow limited breathing; and

providing electrical stimulation according to the protocol to elicit a diaphragm response to thereby reduce flow limitation.

38. The method of claim 37 wherein the step of detecting the flow limitation comprises detecting flow limited breathing.

39. The method of claim 37 wherein the step of detecting the flow limitation comprises detecting an airway obstruction.

40. The method of claim 37 wherein the step of detecting the flow limitation from at least one EMG parameter further comprises:

detecting a diaphragm EMG envelope having a flattened morphology corresponding to a flow limited breathing.

41. The method of claim 37 wherein the step of detecting the flow limitation from at least one EMG parameter further comprises:

detecting a diaphragm EMG complex having an increased width corresponding to flow limited breathing.

42. The method of claim 37 wherein the step of detecting the flow limitation from at least one EMG parameter further comprises:

detecting a diaphragm EMG complex having an increased amplitudes of a plurality of spikes corresponding to flow limited breathing.

43. The method of claim 37 wherein the step of detecting the flow limitation from at least one EMG parameter further comprises:

detecting a diaphragm EMG complex having an increased density of spikes corresponding to flow limited breathing.

44. The method of claim 37 wherein the step of detecting the flow limitation from at least one EMG parameter comprises:

detecting a diaphragm EMG complex having an increased rising slope corresponding to flow limited breathing.

45. The method of claim 37 wherein the step of correlating the at least one cause to an electrical stimulation protocol further comprises defining a type of the electrical stimulation based upon the information from polysomnography.

46. The method of claim 37 wherein the step of correlating the at least one cause to an electrical stimulation protocol further comprises determining one or more stimulation parameters of the electrical stimulation based upon the information from polysomnography.

47. The method of claim 37 further comprising sensing one or more physiological parameters of the subject.

48. The method of claim 47 where the physiological parameters comprise ECG, heart rate, or heart rate variability.