BAROREFLEX ACTIVATION FOR ARRHYTHMIA TREATMENT

• US 20090198294A1
• Filed: 04/10/2009
• Published: 08/06/2009
• Est. Priority Date: 06/30/2004
• Status: Abandoned Application

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Serdar, Davdi S., Rossing, Martin A., Kieval, Robert S., Irwin, Eric D., Martin, Roy C.
• Application Number:
  US12/422,147
• Publication Number:
  US 20090198294A1
• Time in Patent Office: Days
• US Class Current: 607/4
• 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

Abstract

Devices, systems and methods provide baroreflex activation to prevent, or at least reduce the likelihood of occurrence of, cardiac arrhythmias. Various embodiments may additionally or alternatively promote recovery from arrhythmias. In one embodiment, a device for preventing or reducing the likelihood of occurrence of arrhythmias includes one or more baroreflex activation devices, one or more sensors coupled to the baroreflex activation device(s), and a processor for processing information from the sensor and activating and/or modulation the baroreflex activation device. Sensors, such as electrocardiogram devices, generally sense factors indicative of a potential, ensuing arrhythmia.

Claims

1. A method of promoting recovery from an arrhythmia occurring in a heart of a patient, comprising activating a baroreflex system of the patient with at least one baroreflex activation device after occurrence of an arrhythmia event.

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

3. A method as in claim 1, wherein activating the baroreflex system comprises activating a baroreceptor.

4. A method as in claim 3, wherein the baroreceptor is located in at least one of a carotid sinus, aortic arch, heart, common carotid artery, subclavian artery, and brachiocephalic artery.

5. A method as in claim 3, 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 and femoral vein.

6. A method as in claim 1, wherein the baroreflex activation device is implanted in the patient.

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

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

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

sensing a patient condition indicative of an arrhythmia event; and

modifying activation of the baroreflex in response to the sensed patient condition.

10. A method as in claim 9, wherein modifying activation of the baroreflex activation device comprises initiating activation.

11. A method as in claim 9, wherein sensing the patient condition comprises sensing physiological activity with one or more sensors.

12. A method as in claim 11, wherein sensing is performed with at least one device selected from the group consisting of an extracardiac electrocardiogram, an intracardiac electrocardiogram, a pressure sensor and an accelerometer.

13. A method as in claim 11, wherein the sensed patient condition comprises a change in heart rate.

14. A method as in claim 11, wherein the sensed patient condition comprises a change in relative timing of atrial and ventricular contractions.

15. A method as in claim 11, wherein the sensed patient condition comprises a change in a T-wave on an electrocardiogram.

16. A method as in claim 11, wherein the sensed patient condition comprises a change in an S-T segment shape on an electrocardiogram.

17. A method as in claim 11, wherein sensing comprises acquiring pressure data from the patient'"'"'s heart.

18. A method as in claim 17, further comprising converting the pressure data into cardiac performance data.

19. A method as in claim 9, wherein modifying comprises increasing activation of the baroreflex.

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

21. A method as in claim 1, further comprising initiating activation of the baroreflex activation device after anti-arrhythmia pacing has been applied to the heart via a pacemaker.

22. A method as in claim 1, further comprising initiating activation of the baroreflex activation device after an anti-arrhythmia treatment has been applied to the heart via a cardiovertor/defibrillator.

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

sensing a patient parameter indicative of normal body function; and

deactivating the baroreflex activation device in response to the sensed patient parameter.

28. A method as in claim 1, wherein activating the baroreflex system comprises activating one or more nerves coupled with a baroreceptor.

24. A method of promoting recovery from an arrhythmia occurring in a heart of a patient, comprising activating a baroreflex system of the patient with at least one baroreflex activation device in response to an indication that anti-arrhythmia pacing is being applied to the heart via a pacemaker.

25. A method as in claim 24, further comprising modifying activation of the baroreflex activation device after anti-arrhythmia pacing has been applied to the heart via the pacemaker.

26. A method of promoting recovery from an arrhythmia occurring in a heart of a patient, comprising activating a baroreflex system of the patient with at least one baroreflex activation device in response to an indication that anti-arrhythmia treatment is being applied to the heart via a cardiovertor/defibrillator.

27. A method as in claim 26, further comprising modifying activation of the baroreflex activation device after anti-arrhythmia treatment has been applied to the heart via the cardiovertor/defibrillator.

29. A method, comprising:

detecting a predetermined cardiac activity indicated for an antitachycardia shock;

applying neural stimulation in preparation for the shock; and

subcutaneously delivering the shock.

30. The method of claim 29, further comprising applying neural stimulation as part of a prophylactic therapy.

31. The method of claim 30, wherein the prophylactic therapy includes intermittent neural stimulation to prevent ventricular fibrillation.

32. The method of claim 30, wherein applying neural stimulation as part of the prophylactic therapy includes monitoring heart rate, and adjusting the neural stimulation if the heart rate falls below a programmable threshold.

33. A method, comprising:

applying neural stimulation as part of a prophylactic therapy, including;

delivering intermittent neural stimulation to prevent an arrhythmia, or

delivering intermittent neural stimulation to prevent or abate progression of a heart condition or ailment;

detecting a predetermined cardiac activity indicated for an antitachycardia shock; and

subcutaneously delivering the shock.

34. The method of claim 33, wherein applying neural stimulation as part of the prophylactic therapy includes monitoring heart rate, and adjusting the neural stimulation if the heart rate falls below a programmable threshold.

35. A system, comprising:

means for detecting a predetermined cardiac activity indicated for an antitachycardia shock;

means for subcutaneously delivering the shock; and

means for applying a neural stimulation therapy, including;

means for delivering intermittent neural stimulation to prevent an arrhythmia, or

means for delivering intermittent neural stimulation to prevent or abate progression of a heart condition or ailment.

36. The system of claim 35, wherein the means for detecting, the means for applying and the means for subcutaneously delivering are provided by at least two implantable medical devices, including an implantable nerve stimulator and the subcutaneous defibrillator.

37. A system, comprising:

a sensor adapted to detect a predetermined cardiac activity indicated for a defibrillation shock;

a neural stimulator adapted to deliver nerve stimulation;

a defibrillator adapted to subcutaneously deliver the defibrillation shock,

wherein the neural stimulator is adapted to;

deliver neural stimulation prior to the defibrillation shock;

or

deliver intermittent neural stimulation as a prophylactic therapy to prevent an arrhythmia;

or

deliver intermittent neural stimulation as a prophylactic therapy to prevent or abate progression of a heart condition or ailment.

38. An implantable device, comprising:

a shock pulse generator adapted to subcutaneously deliver an antitachycardia shock;

a cardiac activity sensor adapted to detect cardiac activity signals;

a neural stimulator generator adapted to deliver neural stimulation;

a microprocessor adapted to detect a predetermined cardiac activity indicated for the antitachycardia shock using the cardiac activity detected by the cardiac activity sensor to control the shock pulse generator to deliver the antitachycardia shock, and to control the neural stimulator generator to;

deliver neural stimulation prior to the antitachycardia shock;

or

deliver neural stimulation to prevent an arrhythmia;

or

deliver neural stimulation to prevent or abate progression of a heart condition or ailment.

39. The device of claim 39, further comprising at least one satellite electrode adapted for use in wirelessly delivering the neural stimulation from the neural stimulator generator.

40. The device of claim 39, wherein the microprocessor is adapted to control the neural stimulator generator to deliver neural stimulation in response to detecting the predetermined cardiac activity, and to control the shock pulse generator to deliver the antitachycardia shock after delivering the neural stimulation.

41. The device of claim 39, wherein the microprocessor is adapted to control the neural stimulator generator to deliver neural stimulation as part of a prophylactic therapy.

42. A system, comprising:

circuitry to determine when an arrhythmia has terminated; and

a neural stimulator adapted to temporarily deliver a neural stimulation therapy to assist with recovering from the arrhythmia in response to termination of the arrhythmia.

43. The system of claim 43, further comprising:

circuitry to detect an arrhythmia; and

a pulse generator to deliver an arrhythmia therapy to terminate the arrhythmia.

45. The system of claim 43, wherein the neural stimulator is adapted to chronically deliver a neural stimulation signal as part of a chronic therapy and temporarily deliver the neural stimulation therapy to assist with recovering from the arrhythmia.

47. The system of claim 43, further comprising an arrhythmia detector adapted to provide a signal indicative that an arrhythmia is detected, the neural stimulator being adapted to deliver a pretherapy neural stimulation signal in preparation for an arrhythmia therapy in response to the signal indicative that the arrhythmia is detected.

50. The system of claim 43, wherein circuitry to determine when the arrhythmia has terminated includes circuitry to sense at least one parameter indicative of a delivered anti-arrhythmia shock.

51. The system of claim 43, wherein circuitry to determine when the arrhythmia has terminated includes circuitry to sense arrhythmic episodes.

44. The system of claim 44, wherein the pulse generator is adapted to deliver an anti-arrhythmia shock or anti-arrhythmia pacing.

46. The system of claim 46, wherein temporarily delivering the neural stimulation therapy to assist with recovering from the arrhythmia includes withdrawing the neural stimulation signal delivered as part of the chronic therapy.

48. The system of claim 48, wherein the arrhythmia therapy includes an anti-arrhythmia shock therapy, and the pre-therapy neural stimulation signal includes a neural stimulation therapy.

49. The system of claim 48, wherein the arrhythmia therapy includes an antitachycardia pacing, and the pretherapy neural stimulation signal includes a neural stimulation therapy to modify the arrhythmia in preparation for antitachycardia pacing.

52. A method, comprising:

determining that an arrhythmia has terminated; and

upon termination of the arrhythmia, temporarily delivering a neural stimulation therapy to assist with recovering from the arrhythmia.

53. The method of claim 53, further comprising chronically performing a prophylactic neural stimulation therapy before the neural stimulation therapy to assist with recovering from the arrhythmia, or after the neural stimulation therapy to assist with recovering from the arrhythmia, or before and after the neural stimulation therapy to assist with recovering from the arrhythmia.

54. The method of claim 53, wherein temporarily delivering a neural stimulation therapy to assist with recovering from the arrhythmia includes delivering at least a two stage neural stimulation therapy upon termination of the arrhythmia.

56. The method of claim 53, further comprising delivering pretherapy neural stimulation in preparation for the arrhythmia.

57. The method of claim 53, further comprising:

chronically performing a prophylactic neural stimulation therapy;

detecting an arrhythmia;

upon detecting the arrhythmia, delivering pretherapy neural stimulation in preparation for an arrhythmia therapy;

delivering the arrhythmia therapy;

upon arrhythmia termination, temporarily delivering the neural stimulation therapy to assist with recovering from the arrhythmia; and

chronically performing the prophylactic neural stimulation therapy after temporarily delivering the neural stimulation therapy to assist with recovering from the arrhythmia.

55. The method of claim 55, wherein delivering at least the two stage neural stimulation therapy includes withdrawing neural stimulation after arrhythmia termination, and then delivering the neural stimulation therapy to assist with recovery from the arrhythmia.

58. The method of claim 58, wherein delivering pretherapy neural stimulation includes delivering neural stimulation when the arrhythmia therapy includes a antitachycardia shock, or includes delivering neural stimulation to make an arrhythmia more amenable to an antitachycardia pacing (ATP) therapy.

59. A method, comprising:

in response to a therapy trigger, delivering a pretherapy neural stimulation in preparation for delivering a therapy;

delivering the therapy; and

upon completion of delivering of the therapy, delivering a post-therapy neural stimulation to assist with recovering from the therapy.

60. The method of claim 60, wherein delivering a post-therapy neural stimulation to assist with recovering from the therapy includes delivering the post-therapy neural stimulation using a first stage of stimulation and then using a second stage of stimulation distinct from the first stage.

61. The method of claim 60, further comprising chronically performing a prophylactic neural stimulation therapy before the therapy trigger and comprising chronically performing a prophylactic neural stimulation therapy after delivering the post-therapy neural stimulation.

62. A device, comprising:

a controller;

a sensor adapted to cooperate with the controller to detect an atrial arrhythmia event; and

a neural stimulator adapted to stimulate a neural target to elicit a sympathetic response, the controller being adapted to control the neural stimulator to stimulate the neural target in response to the detected atrial arrhythmia event.

63. The device of claim 63, wherein the sensor includes a sensor adapted to sense an electrogram reflective of atrial activity.

64. The device of claim 63, wherein the sensor includes a sensor adapted to sense an electrogram reflective of cardiac activity, and further includes a processor adapted to utilize an algorithm to detect the atrial arrhythmia event.

65. The device of claim 63, wherein the neural stimulator includes a lead adapted to be intravascularly placed proximate to the neural target to transvascularly stimulate the neural target.

66. The device of claim 63, wherein the neural stimulator includes a lead adapted to be intravascularly placed within a subclavian vein, an innominate vein, or an internal jugular vein.

67. The device of claim 63, wherein the neural stimulator is adapted to stimulate sympathetic neural activity in the neural target to elicit a sympathetic response.

68. The device of claim 63, wherein the neural stimulator is adapted to inhibit parasympathetic neural activity in the neural target to elicit a sympathetic response.

69. The device of claim 63, further comprising a pulse generator adapted to cooperate with the controller to deliver antitachycardia pacing, an antitachycardia shock, or an antiarrhythmia drug.

70. A method, comprising:

detecting an atrial arrhythmia event; and

delivering an atrial arrhythmia treatment in response to a detected atrial arrhythmia event, including delivering neural stimulation to elicit a sympathetic response.

71. The method of claim 71, wherein:

detecting an atrial arrhythmia event includes detecting a precursor for an atrial arrhythmia episode; and

delivering neural stimulation to elicit a sympathetic response includes delivering prophylactic neural stimulation to avoid the atrial arrhythmia event.

72. The method of claim 71, wherein:

detecting an atrial arrhythmia event includes detecting an atrial arrhythmia episode; and

delivering neural stimulation to elicit a sympathetic response includes delivering therapeutic neural stimulation for the atrial arrhythmia event.

73. The method of claim 71, wherein delivering neural stimulation to elicit a sympathetic response includes stimulating sympathetic activity in a neural target.

74. The method of claim 71, wherein delivering neural stimulation to elicit a sympathetic response includes transvascularly stimulating a neural target using an electric stimulation signal delivering through at least one intravascularly-positioned electrode.

75. The method of claim 71, wherein delivering a treatment in response to a detected atrial arrhythmia event further includes delivering antitachycardia pacing, delivering an antitachycardia shock, or delivering a drug therapy.

76. A method, comprising:

sensing a patient condition indicative of an arrhythmia;

applying baroreceptor stimulation in preparation for an anti-arrhythmia treatment for the arrhythmia; and

applying the anti-arrhythmia treatment.

77. A method, comprising:

applying baroreceptor stimulation as a part of a chronic stimulus regimen, including;

applying periodic baroreceptor stimulation to prevent an arrhythmia;

or

applying periodic baroreceptor stimulation to prevent and/or treat a heart condition or ailment;

sensing a patient condition indicative of an arrhythmia; and

applying an anti-arrhythmia treatment for the arrhythmia.

78. A system, comprising:

means for sensing a patient condition indicative of an arrhythmia;

means for applying an anti-arrhythmia treatment; and

means for applying a baroreceptor stimulus regimen, including;

means for applying periodic baroreceptor stimulation to prevent an arrhythmia, or

means for applying periodic baroreceptor stimulation to prevent and/or treat a heart condition or ailment.

79. A system, comprising:

a sensor adapted to sense a patient condition indicative of an arrhythmia;

a baroreflex activation device adapted to apply baroreceptor stimulation; and

a defibrillator adapted to apply an anti-arrhythmia treatment,

wherein the baroreflex activation device is adapted to;

apply baroreceptor stimulation prior to the anti-arrhythmia treatment;

or

apply periodic baroreceptor stimulation as a chronic therapy to prevent an arrhythmia;

or

apply periodic baroreceptor stimulation as a chronic therapy to prevent and/or treat a heart condition or ailment.

80. An implantable device, comprising:

an implantable cardioverter defibrillator (ICD) adapted to apply an anti-arrhythmia treatment;

a sensor adapted to measure cardiac activity;

a baroreflex activation device adapted to apply baroreceptor stimulation; and

a processor adapted to determine a patient condition indicative of an arrhythmia using the cardiac activity measured by the sensor, to control the ICD to apply the anti-arrhythmia treatment, and to control the baroreflex activation device to;

apply baroreceptor stimulation in preparation for the anti-arrhythmia treatment;

or

apply baroreceptor stimulation to prevent an arrhythmia;

or

apply baroreceptor stimulation to prevent and/or treat a heart condition or ailment.

81. A system, comprising:

a processor configured to determine when an arrhythmia has occurred; and

a baroreflex activation device adapted to temporarily apply baroreceptor stimulation to promote recovery from the arrhythmia after occurrence of the arrhythmia.

82. A method, comprising:

determining when an arrhythmia has occurred; and

after occurrence of the arrhythmia, temporarily applying baroreceptor stimulation to promote recovery from the arrhythmia.

83. A device, comprising:

a processor;

a sensor adapted to cooperate with the processor to sense an arrhythmia; and

a baroreflex activation device adapted to stimulate a baroreceptor to elicit a sympathetic response, the processor being adapted to control the baroreflex activation device to stimulate the baroreceptor in response to the sensed arrhythmia.

84. A method, comprising:

sensing an arrhythmia; and

applying an anti-arrhythmia treatment in response to a sensed arrhythmia, including applying baroreceptor stimulation to elicit a sympathetic response.