BAROREFLEX THERAPY FOR DISORDERED BREATHING

• US 20070185542A1
• Filed: 12/28/2006
• Published: 08/09/2007
• Est. Priority Date: 03/27/2002
• Status: Abandoned Application

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Kieval, Robert, Rossing, Martin, Keith, Peter, Irwin, Eric, Bolea, Stephen, Persson, Bruce, Serdar, David
• Application Number:
  US11/617,089
• Publication Number:
  US 20070185542A1
• Time in Patent Office: Days
• US Class Current: 607/42
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36117 for treating hypertension

Abstract

Devices, systems and methods are described by which the blood pressure, nervous system activity, and neurohormonal activity may be selectively and controllably reduced by activating baroreceptors. A baroreceptor activation device is positioned near a baroreceptor, preferably a baroreceptor located in the carotid sinus. A control system may be used to modulate the baroreceptor activation device. The control system may utilize an algorithm defining a stimulus regimen which promotes long term efficacy and reduces power requirements/consumption. The baroreceptor activation device may utilize electrodes to activate the baroreceptors. The electrodes may be adapted for connection to the carotid arteries at or near the carotid sinus, and may be designed to minimize extraneous tissue stimulation.

Claims

1. A disordered breathing therapy method, comprising:

delivering a plurality of therapies to treat disordered breathing, including at least an electrical stimulation therapy modulating a patient'"'"'s baroreflex response; and

coordinating delivery of the plurality of disordered breathing therapies.

2. The method of claim 1, wherein delivering the baroreflex therapy modulating the patient'"'"'s baroreflex response comprises electrically stimulating one or more baroreceptor regions.

3. The method of claim 1, wherein delivering the baroreflex therapy modulating the patient'"'"'s baroreflex response comprises electrically stimulating one or more baroreceptor regions selected from the group consisting of an artery, a carotid sinus, aortic arch, or the heart.

4. The method of claim 1, wherein delivering the baroreflex therapy comprises electrically stimulating one or more nerves.

5. The method of claim 1, wherein delivering the baroreflex therapy comprises delivering the baroreflex therapy to increase tidal volume.

6. The method of claim 1, wherein delivering the baroreflex therapy comprises delivering the baroreflex therapy to increase respiration rate.

7. The method of claim 1, wherein delivering the plurality of therapies to treat disordered breathing comprises delivering the plurality of therapies to treat apnea.

8. The method of claim 1, wherein delivering the plurality of therapies to treat disordered breathing comprises delivering the plurality of therapies to treat hypopnea.

9. The method of claim 1, wherein delivering the plurality of therapies to treat disordered breathing comprises delivering the plurality of therapies to treat sleep disordered breathing.

10. The method of claim 1, wherein coordinating delivery of the plurality of disordered breathing therapies comprises shifting from one therapy to another therapy.

11. The method of claim 1, wherein coordinating delivery of the plurality of disordered breathing therapies comprises modifying at least one therapy of the plurality of therapies to enhance therapy efficacy.

12. The method of claim 1, wherein coordinating delivery of the plurality of disordered breathing therapies comprises modifying at least one therapy to reduce an impact of the plurality of disordered breathing therapies on the patient.

13. The method of claim 1, wherein coordinating delivery of the plurality of disordered breathing therapies comprises shifting from a first therapy to one or more other therapies based on patient usage of the first therapy.

14. A disordered breathing therapy system, comprising:

a plurality of therapy devices, each therapy device of the plurality of therapy devices configured to deliver a disordered breathing therapy differing from disordered breathing therapies delivered by other therapy devices of the plurality of therapy devices, at least one of the therapy devices comprising;

one or more electrodes configured to deliver a baroreflex electrical stimulation signal; and

a baroreflex stimulator coupled to the baroreflex electrodes and configured to deliver an electrical stimulation therapy modifying a patient'"'"'s baroreflex response; and

a control system coupled to the plurality of therapy devices, the control system configured coordinate a disordered breathing therapy regimen delivered by the plurality of therapy devices.

15. The system of claim 14, wherein the baroreflex stimulator is configured to modify the baroreflex electrical stimulation therapy.

16. The system of claim 14, wherein the baroreflex stimulator is configured to modify the baroreflex electrical stimulation therapy by adjusting a characteristic of the baroreflex electrical stimulation signal, the characteristic selected from the group consisting of amplitude, frequency, and duty cycle.

17. The system of claim 14, wherein the baroreflex stimulator is configured to initiate delivery of the baroreflex electrical stimulation therapy.

18. The system of claim 14, wherein the baroreflex stimulator is configured to terminate delivery of the baroreflex electrical stimulation therapy.

19. The system of claim 14, wherein the plurality of therapy devices comprises a respiratory therapy device configured to delivery respiratory therapy to treat disordered breathing.

20. The system of claim 14, wherein the control system is configured to reduce at least a first disordered breathing therapy delivered to the patient and increase at least a second disordered breathing therapy delivered to the patient to coordinate delivery of the disordered breathing therapy regimen.

21. The system of claim 14, wherein the control system is configured to terminate a first disordered breathing therapy and initiate a second disordered breathing therapy to coordinate delivery of the disordered breathing therapy regimen.

22. The system of claim 14, further comprising a sensing system coupled to the control system and configured to sense one or more conditions affecting the patient, wherein the control system is configured to modify at least one disordered breathing therapy based on the sensed conditions.

23. The system of claim 14, further comprising:

a sensing system configured to sense one or more conditions indicative of disordered breathing;

a disordered breathing detection circuitry configured to detect disordered breathing based on the sensed conditions, wherein the control system is configured to modify at least one disordered breathing therapy based on the detection of disordered breathing.

24. The system of claim 14, further comprising:

a sensing system configured to sense one or more conditions predictive of disordered breathing;

a disordered breathing detection circuitry configured to predict disordered breathing based on the sensed conditions, wherein the control system is configured to modify at least one disordered breathing therapy based on the prediction of disordered breathing.

25. The system of claim 14, further comprising:

a sensing system configured to sense one or more conditions associated with sleep;

a sleep detector configured to detect sleep based on the sensed conditions, wherein the control system is configured to modify at least one disordered breathing therapy based on the detection of sleep.

26. The system of claim 14, further comprising a sensing system configured to sense one or more conditions associated with therapy efficacy, wherein the control system is configured to evaluate the sensed conditions and modify the disordered breathing therapy regimen to adjust therapy efficacy.

27. The system of claim 14, further comprising a sensing system configured to sense one or more conditions associated with an impact of the therapy on the patient, wherein the control system is configured to evaluate the sensed conditions and modify the disordered breathing therapy regimen to adjust the impact of the therapy on the patient.

28. The system of claim 14, wherein the control system is configured to modify the disordered breathing therapy regimen to increase a useful life of at least one therapy device.

29. The system of claim 14, wherein the control system is configured to coordinate the disordered breathing therapy regimen based on patient usage of one or more particular disordered breathing therapies.

30. A disordered breathing therapy system, comprising:

means for delivering a plurality of therapies to treat disordered breathing, including at least an electrical stimulation therapy modulating a patient'"'"'s baroreflex response; and

means for coordinating delivery of the plurality of disordered breathing therapies.

31. The system of claim 30, further comprising means for electrically stimulating one or more baroreceptor regions.

32. The system of claim 30, further comprising means for shifting from one therapy to another therapy.

33. The system of claim 30, further comprising modifying at least one therapy of the plurality of therapies to enhance therapy efficacy.

34. The system of claim 30, means for shifting from a particular disordered breathing therapy to one or more other disordered breathing therapies based on patient usage of the particular disordered breathing therapy.

35. A method of delivering disordered breathing therapy to a patient, comprising:

delivering electrical stimulation therapy modifying a patient'"'"'s baroreflex response to treat disordered breathing;

sensing one or more conditions affecting the patient; and

adapting the electrical stimulation therapy based on the one or more conditions.

36. The method of claim 35, wherein delivering the electrical stimulation therapy comprises electrically stimulating one or more baroreceptor regions.

37. The method of claim 36, wherein delivering the electrical stimulation therapy comprises electrically stimulating one or more baroreceptor regions located in the group consisting of an artery, a carotid sinus, an aortic arch, or the heart.

38. The method of claim 35, wherein delivering the electrical stimulation therapy comprises electrically stimulating one or more nerves.

39. The method of claim 35, wherein delivering the electrical stimulation therapy comprises delivering the electrical stimulation therapy to increase tidal volume.

40. The method of claim 35, wherein delivering the electrical stimulation therapy that modifies the baroreflex response comprises delivering the electrical stimulation therapy to increase respiration rate.

41. The method of claim 35, wherein sensing the one or more conditions comprises sensing one or more physiological conditions.

42. The method of claim 35, wherein sensing the one or more conditions comprises sensing a condition selected from the group consisting of a cardiac system condition, a respiratory system condition, a nervous system condition, an environmental condition, a non-physiological condition, and a contextual condition.

43. The method of claim 35, further comprising detecting the disordered breathing, wherein delivering the electrical stimulation therapy modifying the patient'"'"'s baroreflex response to treat the disordered breathing comprises delivering the electrical stimulation therapy modifying the patient'"'"'s baroreflex response to mitigate the detected disordered breathing.

44. The method of claim 43, wherein detecting the disordered breathing comprises:

determining respiration patterns; and

detecting the disordered breathing based on the respiration patterns.

45. The method of claim 43, wherein detecting the disordered breathing comprises:

comparing a respiration volume to a threshold value; and

detecting the disordered breathing based on the comparison.

46. The method of claim 35, wherein adapting the electrical stimulation therapy comprises adjusting one or more characteristics of the electrical stimulation.

47. The method of claim 46, wherein adjusting the one or more characteristics of the electrical stimulation comprises adjusting a characteristic selected from the group consisting of amplitude, frequency, duty cycle, and burst pattern.

48. The method of claim 35, wherein adapting the electrical stimulation therapy comprises:

evaluating therapy efficacy; and

adapting the electrical stimulation therapy to adjust therapy efficacy.

49. The method of claim 35, wherein adapting the electrical stimulation therapy comprises:

evaluating an impact of the electrical stimulation therapy to the patient; and

adapting the electrical stimulation therapy to adjust an impact to the patient.

50. The method of claim 35, wherein adapting the electrical stimulation therapy comprises adapting the electrical stimulation therapy to with respect to a blood pressure limit.

51. The method of claim 35, wherein adapting the electrical stimulation therapy adapting the therapy to adjust therapy interactions.

52. The method of claim 35, wherein adapting the electrical stimulation therapy comprises withholding the electrical stimulation therapy.

53. A method of providing disordered breathing therapy to a patient, comprising:

predicting disordered breathing in a patient; and

delivering a preventative therapy modifying a baroreflex response to treat the predicted disordered breathing.

54. The method of claim 53, further comprising:

detecting a disordered breathing event; and

adjusting the preventative therapy based on the detection of the disordered breathing event.

55. The method of claim 53, wherein adjusting the therapy comprises terminating the therapy.

56. A disordered breathing therapy system, comprising:

one or more electrodes configured to deliver a baroreflex stimulation signal;

a sensing system configured to sense one or more conditions affecting a patient; and

a pulse generator coupled to the one or more electrodes and to the sensing system, the pulse generator configured to control delivery of electrical stimulation therapy using the one or more electrodes, the electrical stimulation therapy modifying a patient'"'"'s baroreflex response to treat disordered breathing, the pulse generator further configured to evaluate the one or more conditions affecting the patient and to adapt the electrical stimulation therapy based on the one or more conditions.

57. The system of claim 56, wherein the one or more electrodes are configured to electrically couple to one or more baroreceptor regions selected from the group consisting of arteries, carotid sinus, aortic arch, or the heart.

58. The system of claim 56, wherein the one or more electrodes are configured to electrically couple to one or more nerves.

59. The system of claim 56, wherein the electrical stimulation therapy modifies a patient'"'"'s baroreflex response to increase tidal volume.

60. The system of claim 56, wherein the electrical stimulation therapy modifies a patient'"'"'s baroreflex response to increase respiration rate.

61. The system of claim 56, wherein the sensing system is configured to sense one or more physiological conditions.

62. The system of claim 56, wherein the sensing system is configured to sense one or more non-physiological conditions.

63. The system of claim 56, further comprising a disordered breathing detector coupled to the sensing system and the pulse generator, the disordered breathing detector configured to detect disordered breathing using the one or more sensed conditions, wherein the pulse generator is configured to control delivery of the electrical stimulation therapy modifying the patient'"'"'s baroreflex response to treat the detected disordered breathing.

64. The system of claim 63, wherein the sensing system comprises a respiration sensor configured to sense a physiological condition modulated by respiration cycles and the disordered breathing detector is configured to determine respiration cycle patterns and detect the disordered breathing based on the respiration cycle patterns.

65. The system of claim 56, further comprising a disordered breathing predictor coupled to the sensing system and the pulse generator, the disordered breathing predictor configured to predict disordered breathing using the one or more sensed conditions, wherein the pulse generator is configured to deliver the electrical stimulation therapy modifying the patient'"'"'s baroreflex response to treat the predicted disordered breathing.

66. The system of claim 65, wherein the disordered breathing predictor is configured to evaluate one or more precursor conditions of disordered breathing and to predict the disordered breathing based on the assessment of the one or more precursor conditions, the one or more precursor conditions associated with an imminent onset of disordered breathing.

67. The system of claim 65, wherein the disordered breathing predictor is configured to evaluate one or more conditions predisposing the patient to disordered breathing and predict the disordered breathing based on the assessment of the one or more predisposing conditions.

68. The system of claim 56, wherein the pulse generator is configured to adjust one or more characteristics of the baroreflex stimulation signal.

69. The system of claim 56, wherein the pulse generator is configured to evaluate therapy efficacy and to adapt the electrical stimulation therapy to adjust the therapy efficacy.

70. The system of claim 56, wherein the pulse generator is configured to evaluate an impact of the therapy on the patient and to adapt the electrical stimulation therapy to adjust the impact to the patient.

71. The system of claim 56, wherein the pulse generator is configured to adapt the electrical stimulation therapy with respect to a blood pressure limit.

72. The system of claim 56, wherein the pulse generator is configured to adapt the electrical stimulation therapy to modify therapy interactions.

73. A system for treating disordered breathing, comprising:

means for delivering electrical stimulation therapy modifying a patient'"'"'s baroreflex response to treat disordered breathing;

means for sensing one or more conditions affecting the patient; and

means for adapting the electrical stimulation therapy based on the one or more conditions.

74. The system of claim 73, further comprising:

means for detecting disordered breathing based on the one or more conditions; and

means for adapting the electrical stimulation therapy to treat the detected disordered breathing.

75. The system of claim 73, further comprising:

means for predicting disordered breathing based on the one or more conditions; and

means for adapting the electrical stimulation therapy to treat the predicted disordered breathing.

76. The system of claim 73, further comprising:

means for evaluating therapy efficacy using the one or more conditions; and

means for adapting the electrical stimulation therapy to adjust therapy efficacy.

77. The system of claim 73, further comprising:

means for evaluating an impact of the electrical stimulation therapy on the patient; and

means for adapting the electrical stimulation therapy to adjust the impact on the patient.