System for neurally-mediated anti-arrhythmic therapy

• US 8,983,598 B2
• Filed: 10/04/2006
• Issued: 03/17/2015
• Est. Priority Date: 10/04/2006
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Libbus, Imad, Pastore, Joseph M.
• Primary Examiner(s): VOORHEES, CATHERINE M
• Application Number:
  US11/538,488
• Publication Number:
  US 20080086174A1
• Time in Patent Office: 3,086 Days
• Field of Search: 607/5, 607/7
• US Class Current: 607/5
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion

Abstract

According to an embodiment of a method, a predetermined cardiac activity indicated for an antitachycardia shock is detected. Neural stimulation is applied to lower a defibrillation threshold in preparation for the shock, and the shock is subcutaneously delivered. According to one embodiment, neural stimulation is applied as part of a prophylactic therapy. A predetermined cardiac activity indicated for an antitachycardia shock is detected, and the shock is subcutaneously delivered. Other aspects and embodiments are provided herein.

Claims

1. A method, comprising:

detecting a predetermined cardiac activity indicated for an antitachycardia shock;

applying neural stimulation with a subcutaneous electrode to lower a defibrillation threshold in preparation for the shock; and

subcutaneously delivering the shock from a subcutaneous non-intrathoracic space, wherein subcutaneously delivering the shock includes delivering energy between at least two electrodes operatively positioned in the subcutaneous space to deliver energy across the heart.

2. The method of claim 1, further comprising applying neural stimulation as part of a prophylactic therapy.

3. The method of claim 2, wherein the prophylactic therapy includes intermittent vagal stimulation to prevent ventricular fibrillation.

4. The method of claim 2, wherein the prophylactic therapy includes intermittent vagal stimulation to prevent development of a cardiac disease.

5. The method of claim 2, 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.

6. The method of claim 1, wherein applying neural stimulation to lower a defibrillation threshold includes initiating the neural stimulation to lower the defibrillation threshold less than 10 seconds before delivering the shock.

7. The method of claim 1, wherein applying neural stimulation to lower a defibrillation threshold includes applying neural stimulation for a duration between approximately 5 to approximately 7 seconds.

8. The method of claim 1, wherein subcutaneously delivering the shock includes delivering the shock between at least one electrode on at least one subcutaneously implanted lead and an electrode on a subcutaneously implanted device housing.

9. The method of claim 1, wherein applying the neural stimulation includes applying vagal stimulation with the subcutaneous electrode.

10. The method of claim 1, wherein:

subcutaneously delivering the shock includes using an implantable device to subcutaneously deliver the shock; and

applying the neural stimulation includes applying the neural stimulation using a satellite electrode configured to wirelessly communicate with the implantable device.

11. A system, comprising:

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

a vagal nerve stimulator adapted to use a subcutaneous electrode to deliver vagal nerve stimulation; and

a defibrillator including at least two electrodes configured to be operatively positioned in a subcutaneous non-intrathoracic space to deliver energy across the heart, wherein the defibrillator is configured to subcutaneously deliver the defibrillation shock between the at least two electrodes operatively positioned in the subcutaneous non-intrathoracic space to deliver energy across the heart,

wherein the vagal nerve stimulator is adapted to;

deliver vagal nerve stimulation to lower a defibrillation threshold for the defibrillation shock;

or

deliver intermittent vagal nerve stimulation as a prophylactic therapy to prevent ventricular fibrillation after a myocardial infarction;

or

deliver intermittent vagal nerve stimulation as a prophylactic therapy to prevent or abate progression of cardiac disease.

12. The system of claim 11, wherein the sensor is adapted to detect the predetermined cardiac activity using at least one electrode, and the defibrillator is adapted to subcutaneously deliver the defibrillation shock using the at least one electrode used to detect the predetermined cardiac activity.

13. The system of claim 11, including one implantable device housing adapted to house both the vagal nerve stimulator and the defibrillator.

14. The system of claim 11, including a first implantable housing adapted to house the vagal nerve stimulator and a second implantable housing adapted to house the defibrillator.

15. The system of claim 14, wherein the first implantable housing includes the sensor adapted to detect the predetermined cardiac activity.

16. The system of claim 14, wherein the second implantable housing includes the sensor adapted to detect the predetermined cardiac activity.

17. The system of claim 11, wherein the vagal nerve stimulator is adapted to deliver vagal nerve stimulation to lower a defibrillation threshold for the defibrillation shock.

18. The system of claim 11, wherein a self-powered, implantable satellite device includes the subcutaneous electrode to deliver vagal stimulation.

19. An implantable device, comprising:

at least one subcutaneous lead with at least one electrode configured to be operatively placed in a subcutaneous non-intrathoracic space;

a shock pulse generator configured to subcutaneously deliver an antitachycardia shock between at least two electrodes operatively positioned in the subcutaneous non-intrathoracic space to deliver energy across the heart, wherein the shock pulse generator is configured to use the at least one subcutaneous lead with the at least one electrode to deliver energy across the heart;

a cardiac activity sensor adapted to detect cardiac activity signals;

a nerve stimulator generator adapted to use a subcutaneous electrode to deliver vagal nerve stimulation; and

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 nerve stimulator generator to;

deliver vagal nerve stimulation to lower DFT in preparation for the antitachycardia shock, or

deliver vagal nerve stimulation to prevent ventricular fibrillation after a myocardial infarction, or

deliver vagal nerve stimulation to prevent or abate progression of cardiac disease.

20. The device of claim 19, the subcutaneous electrode includes a satellite electrode.

21. The device of claim 19, wherein the microprocessor is adapted to control the nerve stimulator generator to deliver nerve stimulation to lower a defibrillation threshold in response to detecting the predetermined cardiac activity, and to control the shock pulse generator to deliver the antitachycardia shock after delivering the vagal nerve stimulation.

22. The device of claim 21, wherein the microprocessor is adapted to control the nerve stimulator generator to deliver vagal nerve stimulation to lower a defibrillation threshold for a duration between approximately 5 seconds to approximately 7 seconds.

23. The device of claim 21, wherein the microprocessor is adapted to control the shock pulse generator to deliver the antitachycardia shock within one minute after initiating the vagal nerve stimulation to lower the defibrillation threshold.

24. The device of claim 21, wherein the microprocessor is adapted to control the shock pulse generator to deliver the antitachycardia shock within 10 seconds after initiating the vagal nerve stimulation to lower the defibrillation threshold.

25. The device of claim 19, wherein the microprocessor is adapted to control the nerve stimulator generator to deliver nerve stimulation as part of a prophylactic therapy.

26. The system of claim 19, wherein a self-powered, implantable satellite device includes the subcutaneous electrode to deliver vagal stimulation.

27. A system, comprising:

a neural stimulator adapted to use a subcutaneous electrode to deliver vagal nerve stimulation to lower a defibrillation threshold; and

a subcutaneous non-intrathoracic implantable cardioverter defibrillator (ICD) including at least two electrodes configured to be operatively positioned in a subcutaneous non-intrathoracic space to deliver energy across the heart, wherein the subcutaneous non-intrathoracic ICD is configured to deliver an antitachycardia shock between the at least two electrodes and across the heart, wherein the neural stimulator and the subcutaneous non-intrathoracic ICD are adapted to communicate allowing the neural stimulator to lower the defibrillation threshold after an antitachycardia event has occurred in preparation for delivery of the antitachycardia shock.

28. The system of claim 27, wherein the subcutaneous non-intrathoracic ICD is adapted to detect a predetermined cardiac activity indicated for the antitachycardia shock.

29. The system of claim 27, wherein the neural stimulator is adapted to deliver vagal nerve stimulation to lower the defibrillation threshold for a duration less than 10 seconds before subcutaneous non-intrathoracic ICD delivers the antitachycardia shock.

30. The system of claim 27, wherein a self-powered, implantable satellite device includes the subcutaneous electrode to deliver vagal stimulation.

31. The system of claim 30, wherein the satellite device is configured to wirelessly communicate with the subcutaneous non-intrathoracic ICD.