BAROREFLEX ACTIVATION FOR PAIN CONTROL, SEDATION AND SLEEP

• US 20080208286A1
• Filed: 04/30/2008
• Published: 08/28/2008
• Est. Priority Date: 10/22/2003
• Status: Active Grant

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Kieval, Robert S., Rossing, Martin
• Granted Patent: US 8,478,414 B2
• Time in Patent Office: Days
• US Class Current: 607/46
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

Systems and methods provide baroreflex activation to treat or reduce pain and/or to cause or enhance sedation or sleep. Methods involve activating the baroreflex system to provide pain reduction, sedation, improved sleep or some combination thereof. Systems include at least one baroreflex activation device, at least one sensor for sensing physiological activity of the patient, and a processor coupled with the baroreflex activation device(s) and the sensor(s) for processing sensed data received from the sensor and for activating the baroreflex activation device. In some embodiments, the system is fully implantable within a patient, such as in an intravascular, extravascular or intramural location.

Claims

1. A method for effecting a change in a baroreflex system of a patient to treat or reduce chronic pain the method comprising;

identifying a patient desiring a treatment of or reduction in chronic pain;

advancing at least one baroreceptor activation device through the vasculature to a location selected from the group consisting of intravascular, extravascular, and within a vessel wall;

implanting the baroreflex activation device at the location; and

activating the baroreflex system of the patient with said at least one baroreflex activation device in order to reduce the chronic pain.

2. A method as in claim 1, wherein the baroreflex activation device is implanted in an extravascular location.

3. A method as in claim 1, wherein the baroreflex activation device is implanted in an intravascular location.

4. A method as in claim 1, wherein the baroreflex activation device is implanted in a vessel wall.

5. A method as in claim 1, wherein advancing the device comprises advancing through venous vasculature of the patient.

6. A method as in claim 1, wherein activating the baroreflex system comprises activating at least one of a baroreceptor, one or more nerves coupled with a baroreceptor, and a carotid sinus nerve.

7. A method as in claim 6, wherein at least one baroreceptor is activated.

8. A method as in claim 7, wherein the baroreceptor is located in at least one of a carotid sinus, aortic arch, heart, common carotid artery, subclavian artery, pulmonary artery, femoral artery and brachiocephalic artery.

9. A method as in claim 7, wherein the baroreceptor is located in at least on of an inferior vena cava, superior vena cava, portal vein, jugular vein, subclavian vein, iliac vein, azygous vein, pulmonary vein and femoral vein.

10. A method as in claim 1, wherein activating comprises at least one of electrical activation, mechanical activation, thermal activation and chemical activation.

11. A method as in claim 1, wherein activating comprises at least one of continuous activation, pulsed activation and periodic activation.

12. A method as in claim 1, wherein activating the baroreflex system also causes sedation of the patient.

13. A method as in claim 1, further comprising:

sensing a patient condition indicative of pain with one or more sensor devices; and

initiating or modifying baroreflex activation in response to the sensed patient condition.

14. A method as in claim 13, wherein sensing the patient condition comprises sensing at least one of physiological and neurological activity.

15. A method as in claim 1, wherein activating is controlled by the patient.

16. A method for effecting a change in a baroreflex system of a patient to cause or enhance sedation or sleep, the method comprising:

identifying a patient who desires sedation or sleep;

advancing at least one baroreceptor activation device through the vasculature to a location selected from the group consisting of intravascular, extravascular, and within a vessel wall;

implanting the baroreflex activation device at the location; and

activating the baroreflex system of the patient with at least one baroreflex activation device.

17. A method as in claim 16, wherein the baroreflex activation device is implanted in an extravascular location.

18. A method as in claim 16, wherein the baroreflex activation device is implanted in an intravascular location.

19. A method as in claim 16, wherein the baroreflex activation device is implanted in a vasculature location.

20. A method as in claim 16, wherein activating the baroreflex system comprises activating at least one of a baroreceptor, one or more nerves coupled with a baroreceptor, and a carotid sinus nerve.

21. A method as in claim 16, wherein the baroreceptor is located in at least one of a carotid sinus, aortic arch, heart, common carotid artery, subclavian artery, pulmonary artery, femoral artery and brachiocephalic artery.

22. A method as in claim 16, wherein the baroreceptor is located in at least one of an inferior vena cava, superior vena cava, portal vein, jugular vein, subclavian vein, iliac vein, azygous vein, pulmonary vein and femoral vein.

23. A method as in claim 16, wherein activating comprises at least one of electrical activation mechanical activation, thermal activation and chemical activation.

24. A method as in claim 16, wherein activating comprises at least one of continuous activation pulsed activation and periodic activation.

25. A method as in claim 16, wherein activating comprises at least one of activating at a specified time each day, ending activation at a specified time each day and activating for a specified amount of time each day.

26. A method as in claim 16, wherein activating the baroreflex system also reduces pain felt by the patient.

27. A method as in claim 16, wherein the baroreflex activation causes or enhances sleep, the method further comprising:

sensing a patient condition with one or more sensor devises; and

initiating or modifying baroreflex activation in response to the sensed patient condition.

28. A method as in claim 25, wherein sensing the patient condition comprises sensing at least one of physiological activity and body position indicative of sleep or pre-sleep behavior of the patient.

29. A method as in claim 26, wherein patient body position is sensed via a remote sensing device located apart from the patient.

30. A method as in claim 26, wherein patient body position is sensed via one or more sensors located in a bed.

31. A method as in claim 27, wherein sensing the patient condition comprises sensing at least one or physiological activity and body position indicative of awakening or pre-awakening behavior of the patient.

32. A method as in claim 27, wherein sensing the patient condition comprises learning a behavior pattern of the patient, such that initiating or modifying the baroreflex activation occurs before the patient goes to sleep each day.

33. A method as in claim 27, wherein initiating or modifying the baroreflex activation is based at least in part on a time of day.

34. A method as in claim 16, wherein activating is controlled by the patient.

35. A system for effecting a change in a baroreflex system of a patient to treat or reduce pain and/or cause or enhance sedation or sleep, the system comprising:

at least one baroreflex activation device;

at least one sensor for sensing physiological activity of the patient; and

a processor coupled with the at least one baroreflex activation device and the at least one sensor for processing sensed data received from the sensor and for activating the baroreflex activation device, wherein the system is adapted to activate the baroreflex system at a specified time and for a specified duration each day.

36. A system as in claim 35, wherein the system is fully implantable within the patient.

37. A system as in claim 36, wherein the system is implantable in a location selected from the group consisting of intravascular, extravascular and within a vessel wall.

38. A system as in claim 35, wherein the baroreflex activation device is adapted to provide at least on of a baroreceptor, one or more nerves coupled with a baroreceptor, and a carotid sinus nerve.

39. A system as in claim 35, wherein the baroreflex activation device is adapted to provide at least one of electrical activation, mechanical activation, thermal activation and chemical activation.

40. A system as in claim 35, wherein the baroreflex activation device is adapted to provide at least one of continuous activation, pulsed activation and periodic activation.

41. A system as in claim 35, wherein the system is adapted to activate the baroreflex system at a specified time each day.

42. A system as in claim 41, wherein the system is further adapted to activate the baroreflex system for a specified duration of time each day.

43. A system as in claim 35, wherein the at least one sensor is adapted to sense at least one of physiological activity and body position indicative of sleep or pre-sleep behavior of the patient.

44. A system as in claim 35, wherein the at least one sensor is adapted to sense at least one of physiological activity and neurological activity indicative of pain.

45. A system as in claim 35, wherein the processor is adapted to learn a behavior pattern of the patient, such that initiating or modifying the baroreflex activation occurs before the patient goes to sleep each day.

46. A system as in claim 35, wherein the processor is adapted to accept input from the patient to allow the patient to activate the baroreflex activation.

47. A system for effecting a change in a baroreflex system of a patient to treat or reduce pain and/or cause or enhance sedation or sleep, the system comprising:

at least one baroreflex activation device;

at least one sensor for sensing physiological activity of the patient, wherein the at least one sensor is adapted to sense at least one of physiological activity and body position indicative of sleep or pre-sleep behavior of the patient; and

a processor coupled with the at least one baroreflex activation device and the at least one sensor for processing sensed data received from the sensor and for activating the baroreflex activation device.

48. A system as in claim 47, wherein the system is fully implantable within the patient.

49. A system as in claim 48, wherein the system is implantable in a location selected from the group consisting of intravascular, extravascular and within a vessel wall.

50. A system as in claim 47, wherein the baroreflex activation device is adapted to activate at least one of a baroreceptor, one or more nerves coupled with a baroreceptor, and a carotid sinus nerve.

51. A system as in claim 47, wherein the baroreflex activation device is adapted to provide at least one of electrical activation, mechanical activation, thermal activation and chemical activation.

52. A system as in claim 47, wherein the baroreflex activation device is adapted to provide at least one of continuous activation, pulsed activation and periodic activation.

53. A system for effecting a change in a baroreflex system of a patient to treat or reduce pain and/or cause or enhance sedation or sleep, the system comprising:

at least one baroreflex activation device;

at least one sensor for sensing physiological activity of the patient, wherein the at least one sensor is adapted to sense at least one of physiological activity and neurological activity indicative of pain; and

a processor coupled with the at least one baroreflex activation device and the at least one sensor for processing sensed data received from the sensor and for activating the baroreflex activation device.

54. A system as in claim 53, wherein the system is fully implantable within the patient.

55. A system as in claim 54, wherein the system is implantable in a location selected from the group consisting of intravascular, extravascular and within a vessel wall.

56. A system as in claim 53, wherein the baroreflex activation device is adapted to activate at least one of a baroreceptor, one or more nerves coupled with a baroreceptor, and a carotid sinus nerve.

57. A system as in claim 53, wherein the baroreflex activation device is adapted to provide at least one of electrical activation, mechanical activation, thermal activation and chemical activation.

58. A system as in claim 53, wherein the baroreflex activation device is adapted to provide at least one of continuous activation, pulsed activation and periodic activation.

59. A system for effecting a change in a baroreflex system of a patient to treat or reduce pain and/or cause or enhance sedation or sleep, the system comprising:

at least one baroreflex activation device;

at least one sensor for sensing physiological activity of the patient, wherein the processor is adapted to learn a behavior pattern of the patient, such that initiating or modifying the baroreflex activation occurs before the patient goes to sleep each day; and

a processor coupled with the at least one baroreflex activation device and the at least one sensor for processing sensed data received from the sensor and for activating the baroreflex activation device.

60. A system as in claim 59, wherein the system is fully implantable within the patient.

61. A system as in claim 60, wherein the system is implantable in a location selected from the group consisting of intravascular, extravascular and within a vessel wall.

62. A system as in claim 59, wherein the baroreflex activation device is adapted to activate at least one of a baroreceptor, one or more nerves coupled with a baroreceptor, and a carotid sinus nerve.

63. A system as in claim 59, wherein the baroreflex activation device is adapted to provide at least one of electrical activation, mechanical activation, thermal activation and chemical activation.

64. A system as in claim 59, wherein the baroreflex activation device is adapted to provide at least one of continuous activation, pulsed activation and periodic activation.

65. A system for effecting a change in a baroreflex system of a patient to treat or reduce pain and/or cause or enhance sedation or sleep, the system comprising:

at least one baroreflex activation device;

at least one sensor for sensing physiological activity of the patient, wherein the at least one sensor is adapted to sense at least one of physiological activity and neurological activity indicative of pain; and

a processor coupled with the at least one baroreflex activation device and the at least one sensor for processing sensed data received from the sensor and for activating the baroreflex activation device.

66. A system as in claim 65, wherein the system is fully implantable within the patient.

67. A system as in claim 66, wherein the system is implantable in a location selected from the group consisting of intravascular, extravascular and within a vessel wall.

68. A system as in claim 65, wherein the baroreflex activation device is adapted to activate at least one of a baroreceptor, one or more nerves coupled with a baroreceptor, and a carotid sinus nerve.

69. A system as in claim 65, wherein the baroreflex activation device is adapted to provide at least one of electrical activation, mechanical activation, thermal activation and chemical activation.

70. A system as in claim 65, wherein the baroreflex activation device is adapted to provide at least one of continuous activation, pulsed activation and periodic activation.