Neurostimulation to treat effects of sleep apnea

• US 7,155,278 B2
• Filed: 04/21/2003
• Issued: 12/26/2006
• Est. Priority Date: 04/21/2003
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Mianulli, Marcus J., Zhou, Xiaohong, Mullen, Thomas J., Testerman, Roy L., King, Gary W., Burnes, John E., Hill, Michael R. S.
• Primary Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US10/419,405
• Publication Number:
  US 20040210261A1
• Time in Patent Office: 1,345 Days
• Field of Search: 607/2, 607/117, 607/43, 607/48
• US Class Current: 607/2
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

Neurostimulation is delivered to one or more predetermined locations on or within a patient in order to treat effects of sleep apnea by modulating autonomic nervous activity. Delivery of neurostimulation at predetermined locations can decrease sympathetic nervous activity and/or increase parasympathetic nervous activity, countering the increased intrinsic sympathetic activity associated with apnea-arousal cycles. In some embodiments, neurostimulation is delivered to the spinal cord of the patient via an implanted electrode. In other embodiments, neurostimulation is delivered transcutaneously to the spinal cord or other locations via electrodes located on the surface of the patient. In some embodiments, delivery of neurostimulation is initiated or modified in response to detection of apneas.

Claims

1. A method for treating effects of sleep apnea comprising stimulating a spinal cord of a patient at a predetermined location to modulate activity of an autonomic nervous system of the patient.

2. The method of claim 1, wherein stimulating the spinal cord of the patient comprises stimulating the spinal cord at a location between a first thoracic vertebrae and fourth thoracic vertebrae of the patient.

3. The method of claim 1, wherein stimulating the spinal cord of the patient comprises stimulating the spinal cord at a location between a first cervical vertebrae and a second cervical vertebrae of the patient.

4. The method of claim 1, wherein stimulating the spinal cord comprises stimulating the spinal cord via an electrode implanted within the patient proximate to the spinal cord.

5. The method of claim 1, wherein stimulating the spinal cord comprises delivering at least one of direct current and a pulse train via an electrode located proximate to the neural tissue.

6. The method of claim 1, wherein stimulating the spinal cord comprises at least one of stimulating the spinal cord at a location that reduces sympathetic nervous activity and stimulating the spinal cord at a location that increases parasympathetic nervous activity.

7. The method of claim 1, further comprising determining that the patient is asleep, and wherein stimulating the spinal cord comprises stimulating the spinal cord in response to the determination.

8. The method of claim 1, further comprising:

receiving a signal from a sensor that indicates a physiological parameter of the patient associated with an apnea condition; and

identifying the apnea condition based on the signal, and

wherein stimulating the spinal cord comprises stimulating the spinal cord in response to the identification of the apnea condition.

9. The method of claim 8, wherein identifying the apnea condition comprises identifying an arousal state associated with the apnea condition.

10. The method of claim 8, wherein identifying the apnea condition comprises identifying the apnea condition based on at least one of:

a respiration rate, a respiration depth, a respiration pattern, a respiration rate variability metric, an identification of a Cheyne-Stokes respiration sequence, an oxygen level within blood, a carbon dioxide level within blood, a heart rate, a heart rate variability metric, a heart rate turbulence condition, a Q-T interval length, an S-T interval length, a blood pressure, an intracardiac pressure, an intrathoracic pressure, an activity level of a nerve associated with respiration.

11. The method of claim 8, wherein stimulating the spinal cord comprises modifying stimulation of the spinal cord in response to identifying the apnea condition.

12. The method of claim 11, wherein modifying stimulation comprises at least one of modifying a stimulation amplitude and stimulating the patient at another predetermined location.

13. The method of claim 8, further comprising modifying a stimulation signal to the spinal cord during a period of arousal associated with the identified apnea condition based on the physiological parameter.

14. The method of claim 8, further comprising:

storing at least one piece of information relating to at least one previously identified apnea condition;

modifying a neurostimulation parameter based on the at least one piece of information; and

delivering a neurostimulation signal according to the modified parameter in response to identification of a subsequent apnea condition.

15. A system for treating effects of sleep apnea comprising:

an electrode located at a predetermined site proximate a spinal cord of a patient; and

a processor coupled to the electrode to control delivery of an electrical stimulation therapy to the spinal cord via the electrode to modulate activity of an autonomic nervous system to treat effects of sleep apnea of the patient.

16. The system of claim 15, wherein the electrode is located between a first thoracic vertebrae and a fourth thoracic vertebrae of the patient.

17. The system of claim 15, wherein the electrode is located between a first cervical vertebrae and a second cervical vertebrae of the patient.

18. The system of claim 15, wherein the processor is coupled to an output circuit that is coupled to the electrode, and said processor controls the output circuit to deliver at least one of a direct current and a pulse train via the electrode.

19. The system of claim 15, wherein the processor determines that the patient is asleep, and said processor controls delivery of the electrical stimulation therapy to the spinal cord in response to the determination.

20. The system of claim 19, further comprising a sensor to generate a signal based on at least a one of:

a posture of the patient, an activity level of the patient, a snoring sound of the patient, and wherein the processor determines that the patient is asleep based at least in part on the signal.

21. The system of claim 19, further comprising a patient programmer and wherein the processor determines that the patient is asleep by receiving from the patient programmer an indication that the patient intends to sleep, and further comprising:

means for initiating a decremental time or an incremental timer in response to receiving the indication; and

wherein the processor causes delivery of the electrical stimulation therapy in response to expiration of the decremental timer or the incremental timer.

22. The system of claim 15, further comprising a sensor to generate a signal that indicates a physiological parameter of the patient, and wherein the processor identifies an apnea condition based on the signal and controls delivery of the electrical stimulation therapy to the spinal cord in response to the identification.

23. The system of claim 22, wherein the physiological parameter indicates arousal associated with apnea, and the processor identifies the apnea condition by identifying an arousal associated with apnea.

24. The system of claim 22, wherein processor identifies the apnea condition based at least in part on at least a one of:

a respiration rate, a respiration depth, a respiration pattern, a respiration rate variability, an identification of a Cheyne-Stokes respiration condition, an oxygen level within a body fluid, an oxygen level within a volume of blood, a carbon dioxide level within the volume of blood, a heart rate, a heart rate variability index, a heart rate turbulence condition, a Q-T interval length, an S-T interval length, a blood pressure, an intracardiac pressure, an intrathoracic pressure, a sound associated with a snoring condition, an activity level of a nerve associated with respiration.

25. The system of claim 22, wherein the processor is coupled to an output circuit that is coupled to the electrode, and wherein said processor controls the output circuit to modify the electrical stimulation therapy of the spinal cord in response to the identification.

26. The system of claim 25, wherein the processor controls the output circuit to modify an amplitude of the electrical stimulation therapy.

27. The system of claim 25, wherein the electrode comprises a first electrode located at a first predetermined site, the system further comprising a second electrode located at a second predetermined site, and

wherein the processor controls the output circuit to provide the electrical stimulation therapy to the spinal cord via the second electrode.

28. The system of claim 22, wherein the processor is coupled to an output circuit that is coupled to the electrode, and controls the output circuit to modify the electrical stimulation therapy of the spinal cord during an arousal event associated with the identified apnea condition based on the physiological parameter.

29. The system of claim 22, further comprising a memory coupled to the processor, wherein the processor is coupled to an output circuit that is coupled to the electrode, and

wherein the processor stores information relating to at least one previously identified apnea condition in the memory, and the processor modifies a neurostimulation parameter based on the information, and controls the output circuit to deliver neurostimulation according to the modified parameter in response to identification of a subsequent apnea condition.

30. The system of claim 15, wherein the electrode is a first electrode coupled and the processor is a first processor coupled to the first electrode via a first output circuit, the system further comprising a second processor and a second electrode located proximate to a heart of the patient coupled to the second processor via a second output circuit, and

wherein the first processor controls the first output circuit to deliver electrical stimulation therapy to the spinal cord and the second processor controls the second output to deliver pacing pulses to the heart.

31. The system of claim 15, wherein at least one of the electrode and the processor are implanted within the patient.

32. A method for treating effects of sleep apnea comprising:

stimulating a portion of neural tissue of a patient transcutaneously via an electrode in contact with the patient'"'"'s skin at a predetermined location to modulate activity of an autonomic nervous system of the patient.

33. The method of claim 32, wherein stimulating the portion of neural tissue comprises transcutaneously stimulating the portion of neural tissue via an electrode located within a dermatome associated with an area of a spinal cord of the patient between a first thoracic vertebrae and fourth thoracic vertebrae of the patient.

34. The method of claim 32, wherein transcutaneously stimulating neural tissue comprises transcutaneously stimulating the portion of neural tissue via an electrode located within a dermatome associated with an area of a spinal cord of the patient between a first cervical vertebrae and a second cervical vertebrae of the patient.

35. The method of claim 32, wherein transcutaneously stimulating the portion of neural tissue comprises transcutaneously stimulating the portion of neural tissue via an electrode proximate to an ear of the patient.

36. The method of claim 32, further comprising determining whether the patient is asleep, and wherein transcutaneously stimulating the portion of neural tissue comprises transcutaneously stimulating neural tissue in response to a positive determination that the patient is asleep.

37. The method of claim 32, further comprising:

receiving a signal from a sensor that indicates a physiological parameter of the patient associated with an apnea condition; and

identifying the apnea condition based on the signal, and

wherein transcutaneously stimulating the portion of neural tissue comprises transcutaneously stimulating the portion of neural tissue in response to the identification of the apnea condition.

38. The method of claim 37, wherein identifying the apnea condition comprises identifying an arousal associated with the apnea condition.

39. The method of claim 37, wherein identifying the apnea condition comprises identifying the apnea condition based on at least one of:

a respiration rate, a respiration depth, a respiration pattern, a respiration rate variability, an identification of Cheyne-Stokes respiration, an oxygen level within blood, a carbon dioxide level within blood, a heart rate, a heart rate variability, a heart rate turbulence, a Q-T interval length, an S-T interval length, a sound associated with a snoring condition, a blood pressure.

40. The method of claim 37, wherein transcutaneously stimulating the portion of neural tissue comprises modifying stimulation in response to the identification.

41. The method of claim 37, further comprising modifying the electrical stimulation therapy during a period of arousal associated with the identified apnea condition based on the parameter.

42. The method of claim 37, further comprising:

storing information relating to at least one previously identified apnea condition;

modifying a parameter of neurostimulation based on the information; and

delivering neurostimulation according to the modified parameter in response to identification of a subsequent apnea condition.

43. A system for treating effects of sleep apnea comprising:

an electrode located at a predetermined site on and in contact with a surface of the skin of a patient; and

a processor coupled to the electrode to control transcutaneous delivery of electrical stimulation therapy from the electrode to a portion of neural tissue of the patient to modulate activity of an autonomic nervous system of the patient.

44. The system of claim 43, wherein the electrode is located within a dermatome associated with an area of a spinal cord of the patient between a first thoracic vertebrae and a fourth thoracic vertebrae of the patient.

45. The system of claim 43, wherein the electrode is located between a first cervical vertebrae and a second cervical vertebrae of the patient.

46. The system of claim 43, wherein the electrode is located proximate a portion of an ear of the patient.

47. The system of claim 43, wherein the processor determines whether the patient is asleep, and controls transcutaneous delivery of stimulation in response to a determination that the patient is asleep.

48. The system of claim 43, further comprising a sensor to generate a signal that indicates a physiological parameter of the patient, wherein the processor identifies an apnea condition based on the signal and controls a transcutaneous delivery of electrical stimulation therapy in response to the identification.

49. The system of claim 48, wherein the physiological parameter indicates an arousal associated with the apnea condition, and the processor identified the apnea condition by identifying the arousal associated with apnea condition.

50. The system of claim 48, wherein the processor processes the signal to identify the apnea based on at least a one of:

a respiration rate, a respiration depth, a respiration pattern, a respiration rate variability, an identification of Cheyne-Stokes respiration, an oxygen level within a volume of blood, a carbon dioxide level within a volume of blood, a heart rate, a heart rate variability, a heart rate turbulence, a Q-T interval length, an S-T interval length, a sound associated with a snoring condition, a blood pressure.

51. The system of claim 48, wherein the processor is coupled to an output circuit that is coupled to the electrode, and the processor controls the output circuit to modify the electrical stimulation therapy in response to the identification.

52. The system of claim 48, wherein the processor is coupled to an output circuit that is coupled to the electrode, and the processor controls the output circuit to modify the electrical stimulation therapy during a period of arousal based on the parameter.

53. The system of claim 48, further comprising a memory coupled to the processor, wherein the processor is coupled to an output circuit that is coupled to the electrode, and

wherein the processor stores information relating to an identified apnea condition in the memory, modifies a neurostimulation parameter based on the information, and controls the output circuit to deliver neurostimulation therapy according to the modified parameter in response to detection of a subsequent apnea condition.

54. A system comprising:

means for producing stimulation,

means for delivering the stimulation to a spinal cord of a patient at a predetermined location to modulate activity of an autonomic nervous system of the patient, and

means for identifying an apnea condition, wherein the means for producing stimulation produces the stimulation in response to identification of an apnea condition.

55. The system of claim 54, wherein the means for delivering the stimutation to the spinal cord comprises means for transcutaneously stimulating at least one nerve that couples to the spinal cord.

56. The system of claim 54, further comprising means for determining whether the patient is asleep, wherein the means for producing the stimulation produces the stimulation based on the determination.

57. The system of claim 54, wherein the means for delivering the stimulation comprises means for stimulating at least one of peripheral nerves and muscle tissue that couple to the spinal cord.