CLOSED LOOP NEURAL STIMULATION SYNCHRONIZED TO CARDIAC CYCLES

• US 20100121399A1
• Filed: 01/15/2010
• Published: 05/13/2010
• Est. Priority Date: 04/05/2005
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: McCabe, Aaron, Zhang, Yi, Sathaye, Alok S., Brooke, M. Jason, Libbus, Imad, Caparso, Anthony V., Haefner, Paul A.
• Granted Patent: US 8,406,876 B2
• Time in Patent Office: Days
• US Class Current: 607/17
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/36139 with automatic adjustment

Abstract

Various aspects of the present subject matter relate to a method. According to various method embodiments, cardiac activity is detected, and neural stimulation is synchronized with a reference event in the detected cardiac activity. Neural stimulation is titrated based on a detected response to the neural stimulation. Other aspects and embodiments are provided herein.

Claims

1. A method for treating a patient, comprising:

stimulating a baroreflex system of the patient with a baroreflex activation device according to a baroreflex activation therapy (“

BAT”

);

detecting a pacing pulse generated from a cardiac management device (“

CRM”

) device by the baroreflex activation device; and

adjusting the baroreflex activation therapy in response to the detected pacing pulse.

2. The method of claim 1, wherein the baroreflex activation device is connectable to an output terminal of the pacing pulse generator CRM device.

3. The method of claim 1, wherein the baroreflex activation device adjusts the timing of at least one baroreflex stimulation pulse based on detection of the detected pacing pulse.

4. The method of claim 3, wherein the baroreflex activation device comprises a pulse generator for providing at least one baroreflex stimulation pulse.

5. The method of claim 3, wherein adjusting the BAT comprises changing one or more characteristics of pulses generated by the baroreflex activation device.

6. The method of claim 5, wherein the characteristics of the pulse generated by the baroreflex activation device includes any one or more of pulse amplitude, frequency, burst energy, and wave characteristics.

7. The method of claim 1, wherein the BAT is delivered at a pre-selected time after detecting pacing pulses generated by the CRM device.

8. The method of claim 1, wherein the stimulation comprises stimulating a nerve or receptor.

9. The method of claim 8, wherein the nerve or receptor is a baroreceptor or a nerve leading from a baroreceptor.

10. The method of claim 1, wherein the intensity of the BAT is adjusted in response to the frequency of the detected pacing pulse.

11. The method of claim 1, wherein the BAT is performed in multiple steps.

12. The method of claim 1, wherein there is a pre-determined time delay between applying the multiple steps of the BAT.

13. The method of claim 1, wherein the BAT is delivered during systole or diastole cardiac phases.

14. The method of claim 7, wherein stimulating a baroreflex system includes delivering stimulation bursts with multiple burst durations and burst interval sequences, and wherein adjusting the baroreflex activation therapy includes adjusting the delivery of neural stimulation pulses based on heart rate.

15. The method of claim 1, wherein the baroreflex activation device and the CRM device are implantable within the patient.

16. The method of claim 15, wherein the baroreflex activation device and the CRM device are combined in a single housing.

17. The method of claim 15, wherein the baroreflex activation device and the CRM device are each housed in a separate housing.

18. The method of claim 1, wherein the pacing pulse generated by the CRM device is responsive to at least one or more of heart rate, cardiac waveform, timing of arterial and/or ventricular contractions, venous or arterial pressure, venous or arterial volume, cardiac output, pressure and/or volume in one or more heart chambers, cardiac efficiency, cardiac impedance, and edema.

19. The method of claim 1, wherein the method further comprises treatment of hypertension as well as resynchronization of the patient'"'"'s heart.

20. The method of claim 1, wherein the method further comprises treatment of hypertension cardiac arrhythmia.

21. A method for treating a patient, comprising:

stimulating a baroreflex system of the patient with a baroreflex activation device according to a baroreflex activation therapy (“

BAT”

) during systole and diastole cardiac phases;

determining the patient'"'"'s response to the baroreflex stimulation during the systole and diastole cardiac phases.

22. The method of claim 21, further comprising determining when to deliver BAT in the cardiac cycle.

23. The method of claim 21, further comprising selecting a pre-determined time delay between the BAT such that the therapy is delivered at a desired time in the cardiac cycle

24. The method of claim 21, further comprising detecting a pacing pulse generated from a CRM device by the baroreflex activation device.

25. The method of claim 24, wherein the baroreflex activation device is connectable to an output terminal of the CRM device.

26. The method of claim 24, further comprising adjusting the baroreflex system therapy in response to the detected pacing pulse.

27. The method of claim 23, wherein BAT is delivered after the pre-determined time delay.

28. The method according to claim 26, wherein the adjusting step as necessary is performed in a continuous loop to maintain effective BAT.

29. A method for treating a patient, comprising:

stimulating a baroreflex system of the patient according to a baroreflex activation therapy during the systole and the diastole of the cardiac phases; and

measuring the patient'"'"'s response to the stimulation during the systole and diastole cardiac phases; and

determining when to deliver BAT in a cardiac cycle, wherein the cardiac cycle includes systole and diastole phases.

30. The method of claim 29, wherein BAT is delivered after a pre-determined time delay such that BAT is delivered during the preferred cardiac phase.

31. The method of claim 29, further comprising:

stimulating the baroreflex system of the patient according to a therapy during the preferred cardiac phase; and

detecting by the baroreflex activation device a pacing pulse generated from a CRM device.

32. The method of claim 29, wherein the baroreflex activation device is connectable to an output terminal of the CRM device, the method further comprising continuously detecting the pacing pulse.

33. The method of claim 31, further comprising adjusting the baroreflex system therapy in response to the detected pacing pulse.

34. A method for treating a patient, comprising:

stimulating a baroreflex system of the patient according to a BAT deliverable by a baroreflex activation device being connected to an output terminal of a pacing pulse generator of a CRM device;

establishing a pre-determined time delay period prior to delivery of the BAT;

monitoring the pacing pulse during a pre-determined control time period; and

monitoring by the baroreflex activation device the output terminal of the CRM device for pacing pulse activity.

35. The method of claim 34, wherein the method further comprises delivering the baroreflex therapy upon expiration of the time delay and detection of pacing pulse.

36. The method of claim 34, wherein the baroreflex therapy is delivered even if no pacing pulse is detected after expiration of the controlled time period.

37. The method of claim 34, wherein the baroreflex activation device is connectable to an output terminal of the pacing CRM device, the method further comprising continuously monitoring of CRM device for generation of pacing pulse, until the baroreflex activation device detects a pacing pulse.

38. The method of claim 37, further comprising determining when to deliver BAT in a cardiac cycle, wherein the cardiac cycle includes cardiac phases, wherein the time delay is based on determining when the BAT is to be delivered in the cardiac cycle.

39. A baroreflex activation system for treating a patient, comprising:

a baroreflex activation device connectable electrically connectable to an output terminal of a CRM device; and

the baroreflex activation device including detecting circuitry for detecting at least one electrical pulse generated by the CRM device.

40. The system of claim 39, wherein the baroreflex activation device is programmable to apply a BAT including a plurality of therapy regimens.

41. The system of claim 39, wherein the CRM device comprises any one or more of a cardiac pacemaker, an implantable defibrillator, a cardioverter, a cardiac resynchronization device, or a combination device thereof.

42. The system of claim 41, wherein the pacing pulse is generated by a cardiac pacemaker.

43. The system of claim 41, wherein the pacing pulse is generated by an integrated pacemaker/defibrillator.

44. The system of claim 39, wherein the baroreflex activation device and the CRM device are housed in separate housings.

45. The system of claim 39, wherein the baroreflex activation device and the CRM device are housed in a single housing.

46. A method for treating a patient, comprising:

detecting a contraction in a heart of the patient; and

activating a baroreflex system of the patient after expiration of a pre-selected period of time.

47. The method of claim 46, wherein detecting a contraction in the heart of the patient comprises detecting electrical activity in the heart.

48. The method of claim 47, wherein detecting a contraction in the heart of the patient comprises detecting an R-wave in an electrocardiogram signal from the heart of the patient.

49. The method of claim 46, wherein detecting a contraction in the heart comprises detecting an electric pulse generated by a CRM device.

50. A method for treating a patient, comprising:

detecting an electric pulse generated by a CRM device; and

activating a baroreflex system of the patient after expiration of a pre-selected period of time.

51. The method of claim 50, wherein the CRM device comprises a pacemaker.

52. The method of claim 50, wherein the CRM device comprises a cardiac resynchronization therapy (CRT) device.

53. The method of claim 50, wherein the CRM device comprises a cardioverter.

54. The method of claim 50, wherein detecting the electric pulse generated by the CRM device comprises measuring a voltage difference between a BAT electrode and a housing of a BAT device.

55. The method of claim 50, wherein detecting the electric pulse generated by the CRM device comprises measuring a voltage difference between a lead of the CRM device and a housing of a BAT device.

56. The method of claim 50, wherein detecting the electric pulse generated by the CRM device comprises measuring a voltage difference between a lead of the CRM device and an electrode of a BAT device.

57. A method for treating a patient, comprising:

identifying a preferred phase of the patient'"'"'s cardiac cycle for delivery of BAT to the patient'"'"'s baroreflex system; and

activating the baroreflex system of the patient during the preferred phase of the patient'"'"'s cardiac cycle.

58. The method of claim 57, wherein identifying a preferred phase of the patient'"'"'s cardiac cycle comprises:

stimulating the baroreflex system of the patient during a systolic phase and a diastolic phase of the patient'"'"'s cardiac cycle;

quantifying responses to stimulating the baroreflex system; and

monitoring the responses to stimulating during the systolic phase and the diastolic phase.

59. The method of claim 58, further comprising identifying the preferred phase for the delivery of the BAT.

60. The method of claim 58, wherein activating the activating the baroreflex system of the patient during the preferred phase of the patient'"'"'s cardiac cycle includes activating the baroreflex system of the patient during the diastolic phase.

61. The method of claim 58, wherein activating the activating the baroreflex system of the patient during the preferred phase of the patient'"'"'s cardiac cycle includes activating the baroreflex system of the patient during the systolic phase.

62. A method for treating a patient, comprising:

detecting ventricular fibrillation in a heart of the patient;

defibrillating the heart of the patient; and

activating a baroreflex system of the patient to reduce the likelihood of the occurrence of ventricular fibrillation.

63. A method for treating a patient, comprising:

detecting an electric pulse generated by a CRM device; and

activating a baroreflex system of the patient in response to the detected electric pulse.

64. The method of claim 63, wherein the CRM device comprises a defibrillator.

65. The method of claim 63, further comprising discontinuing the activation of the baroreflex system of the patient after expiration of a pre-selected period of time.

66. A method for treating a patient, comprising:

delivering baroreflex activation therapy to a body of the patient;

detecting an electrical pulse generated by a CRM device; and

increasing an intensity of the baroreflex activation therapy upon detection of the electrical pulse.

67. The method of claim 66, wherein the CRM device comprises an implantable defibrillator.

68. The method of claim 66, further comprising returning the baroreflex activation therapy to an original intensity after expiration of a pre-selected period of time.

69. A method for treating a patient, comprising:

delivering baroreflex activation therapy to a body of the patient at a first intensity;

detecting an electrical pulse generated by a CRM device; and

delivering baroreflex activation therapy to the body of the patient at a second intensity after the electrical pulse has been detected.

70. The method of claim 69, wherein the second intensity is greater than the first intensity.

71. The method of claim 69, wherein the CRM device comprises an implantable defibrillator.

72. The method of claim 69, further comprising delivering baroreflex activation therapy to the body of the patient at the first intensity after expiration of a pre-selected period of time.