Cardiac harness for treating congestive heart failure and for defibrillating and/or pacing/sensing

• US 7,146,226 B2
• Filed: 10/13/2004
• Issued: 12/05/2006
• Est. Priority Date: 11/07/2003
• Status: Expired due to Fees

• Current Assignee: Paracor Medical, Inc.
• Original Assignee: Paracor Medical, Inc.
• Inventors: Mar, Craig, Fishler, Matthew G., Lau, Lilip
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): ALTER, ALYSSA MARGO
• Application Number:
  US10/964,420
• Publication Number:
  US 20050102015A1
• Time in Patent Office: 783 Days
• Field of Search: 607/129, 607/130, 607/131, 607/132, 607/9, 600/16
• US Class Current: 607/129
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61F 2002/2484 Delivery devices therefor
• CPC Class Codes: A61N 1/0563 specially adapted for defibrillation or cardioversion
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

A system for treating the heart includes a cardiac harness associated with a cardiac rhythm management devise which includes at least electrodes and a power source. The cardiac harness applies a compressive force on the heart during diastole and systole. The electrodes will deliver an electrical shock to the heart for defibrillation and/or can be used for pacing/sensing. The cardiac harness and electrodes are delivered and implanted on the heart by minimally invasive access.

Claims

1. A method for delivering an electrode to a heart of a patient, comprising:

providing at least one electrode for defibrillation and/or pacing and sensing;

the at least one electrode having a first surface facing an epicardial surface of the heart and a second surface facing away from the epicardial surface of the heart, the second surface being coated with a dielectric material;

forming a minimally invasive access site in a patient;

forming a small incision in a pericardium of the heart;

inserting the at least one electrode through the minimally invasive access site and through the small incision in the pericardium; and

positioning the at least one electrode on or near the epicardial surface of the heart.

2. The method of claim 1, wherein a lead is attached to the at least one electrode for providing an electrical connection to a power source.

3. The method of claim 1, wherein a power source is inserted through the minimally invasive access site and the at least one electrode is electrically connected to the power source.

4. The method of claim 1, wherein the at least one electrode is positioned on a cardiac harness mounted on the heart for providing therapy to the heart.

5. The method of claim 1, wherein the at least one electrode is positioned on a cardiac harness before inserting the at least one electrode through the minimally invasive access site.

6. The method of claim 5, wherein a lead is connected to the at least one electrode before inserting the at least one electrode through the minimally invasive access site.

7. The method of claim 5, wherein a lead is connected to the at least one electrode after inserting the at least one electrode through the minimally invasive access site.

8. The method of claim 1, wherein multiple electrodes are simultaneously inserted through the minimally invasive access site.

9. The method of claim 8, wherein the multiple electrodes are simultaneously inserted through the small incision in the pericardium.

10. The method of claim 9, wherein the multiple electrodes are simultaneously positioned on or near the epicardial surface of the heart.

11. The method of claim 8, wherein a lead is connected to each of the electrodes for providing a connection to a power source.

12. The method of claim 11, wherein the electrodes have a length substantially aligned with a longitudinal axis of the heart.

13. The method of claim 1, wherein the at least one electrode is positioned on the heart.

14. A method for delivering electrodes, comprising:

providing a plurality of electrodes for defibrillation and/or pacing and sensing;

the plurality of electrodes having a first surface facing an epicardial surface of the heart and a second surface facing away from the epicardial surface of the heart, the second surface being coated with a dielectric material;

forming a minimally invasive access site in a patient;

forming an incision in a pericardium of a heart;

simultaneously inserting the plurality of electrodes through the minimally invasive access site;

advancing the plurality of electrodes distally into the patient;

inserting the plurality of electrodes through the incision in the pericardium; and

positioning the plurality of electrodes between the pericardium and the epicardial surface of the heart.

15. The method of claim 14, wherein the plurality of electrodes are spaced around the circumference of the heart.

16. The method of claim 14, wherein the plurality of electrodes have a length, the length being substantially aligned with a longitudinal axis of the heart.

17. The method of claim 14, wherein the plurality of electrodes are attached to a cardiac harness before being inserted through the minimally invasive access site.

18. The method of claim 14, wherein the plurality of electrodes are releasably contained in a delivery device prior to insertion through the minimally invasive access site.

19. The method of claim 18, wherein the plurality of electrodes are advanced distally out of the delivery device and onto or near the epicardial surface of the heart.

20. The method of claim 14, wherein prior to inserting the electrodes through the minimally invasive access site, the electrodes are attached to a cardiac harness and the electrodes and cardiac harness are releasably contained in a delivery device.

21. The method of claim 20, wherein the delivery device is inserted through the incision in the pericardium.

22. The method of claim 21, wherein the electrodes and the cardiac harness are advanced out of the delivery device and onto the epicardial surface of the heart.

23. The method of claim 14, wherein a power source is implanted in the patient and connected to the electrodes by leads for providing electrical stimulation to the heart.

24. The method of claim 23, wherein the power source delivers a defibrillating shock through the leads and the electrodes.

25. The method of claim 23, wherein the power source provides electrical power to the electrodes for providing sensing and pacing therapy to the patient.

26. The method of claim 14, wherein the electrodes are simultaneously positioned onto or near the epicardial surface of the heart.

27. A method for delivering an electrode to a heart, comprising:

forming a minimally invasive access site between two ribs of a patient;

forming a small incision in a pericardium of the heart;

inserting an electrode through the minimally invasive access site;

the electrode having a first surface facing an epicardial surface of the heart and a second surface facing away from the epicardial surface of the heart, the second surface being coated with a dielectric material;

inserting the electrode through the small incision in the pericardium; and

positioning the electrode between the pericardium and the epicardial surface of the heart for defibrillation and/or pacing and sensing.

28. The method of claim 27, wherein a lead is connected to the electrode.

29. The method of claim 28, wherein a power source is connected to the lead.

30. The method of claim 27, wherein a power source is inserted through the minimally invasive access site and electrically connected to the electrode.

31. The method of claim 27, wherein the electrode is attached to a cardiac harness before the electrode is inserted through the minimally invasive access site.

32. The method of claim 31, wherein the electrode and the cardiac harness are inserted into a delivery device.

33. The method of claim 32, wherein the delivery device is inserted through the minimally invasive access site and through the incision in the pericardium.

34. The method of claim 33, wherein the electrode and the cardiac harness are advanced distally out of the delivery device and the cardiac harness is mounted on the epicardial surface of the heart.

35. The method of claim 34, wherein the electrode contacts the epicardial surface of the heart.

36. The method of claim 34, wherein the electrode is near the epicardial surface of the heart.

37. A method for delivering and implanting electrodes on the heart, comprising:

forming a minimally invasive access site in a patient;

inserting electrodes through the minimally invasive access site;

the electrodes having a first surface facing an epicardial surface of the heart and a second surface facing away from the epicardial surface of the heart, the second surface being coated with a dielectric material; and

positioning the electrodes on the heart for defibrillation and/or pacing and sensing.

38. The method of claim 37, wherein the electrodes are inserted through the minimally invasive access site at the same time.

39. The method of claim 37, wherein an incision is formed in the pericardium so that the electrodes are inserted through the incision and positioned between the pericardium and an epicardial surface of the heart.

40. The method of claim 39, wherein the electrodes are attached to a cardiac harness before inserting the electrodes through the minimally invasive access site.

41. The method of claim 37, wherein the electrodes are connected to a power source for delivering a defibrillating shock.

42. The method of claim 37, wherein the electrodes are connected to a power source for providing sensing and pacing therapy.

43. The method of claim 37, wherein the electrodes are connected to a power source for providing a defibrillating shock and for sensing and pacing therapy.

44. The method of claim 43, wherein the power source is inserted through the minimally invasive access site and implanted in the patient.

45. A method for delivering an electrode to a heart of a patient, comprising:

providing at least one electrode for defibrillation and/or pacing and sensing;

the at least one electrode having a first surface facing an epicardial surface of the heart and a second surface facing away from the epicardial surface of the heart, the second surface being coated with a dielectric material;

forming a first minimally invasive access site in a patient;

forming a small incision in a pericardium of the heart;

inserting the at least one electrode through the minimally invasive access site and through the small incision in the pericardium;

positioning the at least one electrode on or near the epicardial surface of the heart; and

forming a second minimally invasive access site in the patient and inserting a power source for implanting in the patient.

46. The method of claim 45, wherein the at least one electrode is electrically connected to the power source for providing electrical stimulation to the heart.

47. The method of claim 46, wherein the at least one electrode is positioned on a cardiac harness mounted on the heart for providing defibrillation or pacing therapy.

48. The method of claim 47, wherein the at least one electrode is positioned on the cardiac harness before inserting the at least one electrode through the first minimally invasive access site.