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

• US 7,149,588 B2
• Filed: 03/03/2004
• Issued: 12/12/2006
• 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:
  US10/793,549
• Publication Number:
  US 20050102012A1
• Time in Patent Office: 1,014 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 of delivering a cardiac harness assembly to the heart, comprising:

a. providing a cardiac harness assembly having a highly elastic metallic cardiac harness and at least one electrode;

b. electrically insulating the metallic cardiac harness from the at least one electrode;

c. providing a delivery device for carrying the cardiac harness assembly;

d. providing a minimally invasive access site;

e. inserting the delivery device through the minimally invasive access site; and

f. delivering the cardiac harness assembly to the heart.

2. The method of claim 1, wherein the minimally invasive access site is positioned between the ribs.

3. The method of claim 2, wherein the delivery device is inserted through the access site positioned between the ribs.

4. The method of claim 1, wherein the delivery device has a proximal end extending outside the body and a distal end extending inside the body.

5. The method of claim 4, wherein the distal end of the delivery device is configured to engage the heart.

6. The method of claim 5, wherein the distal end of the delivery device includes a suction member for engaging the heart and a vacuum device to create negative pressure in the suction member so that the suction member is releaseably attached to the heart.

7. The method of claim 6, wherein a syringe draws a vacuum to create the negative pressure in the suction member.

8. The method of claim 6, wherein after the suction member engages the heart and a negative pressure is drawn, the delivery device is slightly withdrawn proximally so that the heart at least partially elongates.

9. The method of claim 8, wherein the cardiac harness assembly is advanced distally out of the delivery device and onto the heart.

10. The method of claim 9, wherein prior to inserting the delivery device through the access site, making an incision in the pericardium so that the cardiac harness assembly is mounted on the epicardial surface of the heart and under the pericardium.

11. The method of claim 10, wherein the cardiac harness assembly advances distally out of the delivery device, over the suction member, and slides onto the epicardial surface of the heart.

12. The method of claim 11, wherein the negative pressure is released and the suction member disengages from the heart.

13. The method of claim 12, wherein the delivery device is withdrawn proximally from the access site.

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

15. The method of claim 14, wherein the at least one electrode is a defibrillator electrode for providing a defibrillating shock to the heart.

16. The method of claim 14, wherein the at least one electrode is a pacing electrode for providing pacing therapy to the heart.

17. The method of claim 14, wherein the at least one electrode is a pacing/sensing electrode to provide pacing and sensing therapies to the heart.

18. The method of claim 14, wherein multiple electrodes are attached to the cardiac harness, and wherein at least some of the electrodes are defibrillating electrodes and at least some of the electrodes are pacing/sensing electrodes.

19. The method of claim 14, wherein the at least one electrode has a lead extending from a portion of the electrode near the apex of the heart to the power source.

20. The method of claim 1, wherein the delivery of the cardiac harness assembly to the heart is monitored by viewing any of magnetic resonance imaging (MRI), fluoroscopy and echocardiography.

21. A method for treating and preventing congestive heart failure by mounting a cardiac harness assembly on the heart, comprising:

a. providing a cardiac harness assembly having a highly elastic metallic cardiac harness and at least one electrode;

b. providing a delivery device for carrying the cardiac harness assembly;

c. providing a minimally invasive access site;

d. inserting the delivery device through the minimally invasive access site;

e. mounting the cardiac harness assembly on the heart by sliding the harness over the heart and not unrolling the harness; and

f. wherein the cardiac harness provides compressive force on the heart during diastole and systole.

22. The method of claim 21, wherein the delivery device has a proximal end extending outside the body and a distal end extending inside the body.

23. The method of claim 22, wherein the distal end of the delivery device includes a suction member for engaging the heart and a vacuum device to create negative pressure in the suction member so that the suction member releaseably attaches to the heart.

24. The method of claim 23, wherein a syringe draws a vacuum to create the negative pressure in the suction member.

25. The method of claim 23, wherein after the suction member engages the heart and a negative pressure is drawn, the delivery device is slightly withdrawn proximally so that the heart at least partially elongates.

26. The method of claim 25, wherein the cardiac harness assembly is advanced distally out of the delivery device and onto the heart.

27. The method of claim 26, wherein prior to inserting the delivery device through the access site, making an incision in the pericardium so that the cardiac harness assembly is mounted on the epicardial surface of the heart and under the pericardium.

28. The method of claim 27, wherein the cardiac harness assembly advances distally out of the delivery device, over the suction member, and slides onto the epicardial surface of the heart.

29. The method of claim 28, wherein the negative pressure is released and the suction member disengages from the heart.

30. The method of claim 29, wherein the delivery device is withdrawn proximally from the access site.

31. The method of claim 21, wherein the at least one electrode is attached to a power source for providing an electrical stimuli.

32. The method of claim 31, wherein the at least one electrode is a defibrillator electrode for providing a defibrillating shock to the heart.

33. The method of claim 31, wherein the at least one electrode is a pacing electrode for providing pacing therapy to the heart.

34. The method of claim 31, wherein the at least one electrode is a pacing/sensing electrode to provide pacing and sensing therapies to the heart.

35. The method of claim 31, wherein multiple electrodes are attached to the cardiac harness, and wherein at least some of the electrodes are defibrillating electrodes and at least some of the electrodes are pacing/sensing electrodes.

36. The method of claim 21, wherein the minimally invasive access site is located between the ribs so that the cardiac harness assembly is adjacent to the heart.

37. The method of claim 36, wherein the delivery device is inserted between the ribs.

38. The method of claim 31, wherein the at least one electrode has a lead extending from a portion of the electrode near the apex of the heart to the power source.

39. The method of claim 21, wherein the delivery of the cardiac harness assembly to the heart is monitored by viewing any of magnetic resonance imaging (MRI), fluoroscopy and echocardiography.

40. A method of mounting a cardiac harness assembly on the heart, comprising:

a. providing a cardiac harness assembly having a highly elastic metallic cardiac harness and at least one electrode;

b. providing a delivery device for carrying the cardiac harness assembly;

c. compressing the cardiac harness assembly and inserting the cardiac harness assembly into the delivery device;

d. providing a minimally invasive access site;

e. inserting the delivery device through the minimally invasive access site; and

f. sliding the cardiac harness assembly on the heart but not unrolling the harness.

41. The method of claim 40, wherein the delivery device has a proximal end extending outside the body and a distal end extending inside the body.

42. The method of claim 41, wherein the distal end of the delivery device is configured to engage the heart.

43. The method of claim 42, wherein the distal end of the delivery device includes a suction member for engaging the heart and a vacuum device to create negative pressure in the suction member so that the suction member is releaseably attached to the heart.

44. The method of claim 43, wherein a syringe draws a vacuum to create the negative pressure in the suction member.

45. The method of claim 44, wherein after the suction member engages the heart and a negative pressure is drawn, the delivery device is slightly withdrawn proximally so that the heart at least partially elongates.

46. The method of claim 45, wherein the cardiac harness assembly is advanced distally out of the delivery device and onto the heart.

47. The method of claim 46, wherein prior to inserting the delivery device through the access site, making an incision in the pericardium so that the cardiac harness assembly is mounted on the epicardial surface of the heart and under the pericardium.

48. The method of claim 47, wherein the cardiac harness assembly advances distally out of the delivery device, over the suction member, and slides onto the epicardial surface of the heart.

49. The method of claim 48, wherein the negative pressure is released and the suction member disengages from the heart.

50. The method of claim 49, wherein the delivery device is withdrawn proximally from the access site.

51. The method of claim 40, wherein the at least one electrode is attached to a power source for providing electrical stimuli.

52. The method of claim 51, wherein the at least one electrode is a defibrillator electrode for providing a defibrillating shock to the heart.

53. The method of claim 51, wherein the at least one electrode is a pacing electrode for providing pacing therapy to the heart.

54. The method of claim 51, wherein the at least one electrode is a pacing/sensing electrode to provide pacing and sensing therapies to the heart.

55. The method of claim 51, wherein multiple electrodes are attached to the cardiac harness, and wherein at least some of the electrodes are defibrillating electrodes and at least some of the electrodes are pacing/sensing electrodes.

56. The method of claim 40, wherein the minimally invasive access site is positioned between the ribs.

57. The method of claim 56, wherein the delivery device is inserted through the access site positioned between the ribs.

58. The method of claim 51, wherein the at least one electrode has a lead extending from a portion of the electrode near the apex of the heart to the power source.

59. The method of claim 40, wherein the delivery of the cardiac harness assembly to the heart is monitored by viewing any of magnetic resonance imaging (MRI), fluoroscopy and echocardiography.

60. A method of delivering a cardiac harness assembly to the heart, comprising:

a. providing a cardiac harness assembly having a highly elastic metallic cardiac harness and at least one electrode;

b. electrically insulating the cardiac harness from the at least one electrode;

c. providing a delivery device for carrying the cardiac harness assembly;

d. providing a minimally invasive access site;

e. inserting the delivery device through the minimally invasive access site;

f. releasably attaching the delivery device to the heart and creating wall tension on the heart by slightly withdrawing the delivery device and thereby slightly elongating the heart; and

g. delivering the cardiac harness assembly to the heart.

61. The method of claim 60, wherein as the delivery device is slightly withdrawn a resistive force is created between the delivery device and the heart so that the cardiac harness easily slides over the tensioned heart.

62. The method of claim 60, wherein the minimally invasive access site is positioned between the ribs so that the cardiac harness assembly is adjacent to the heart.

63. The method of claim 62, wherein the delivery device is inserted through the access site positioned between the ribs.

64. The method of claim 61, wherein the delivery device has a proximal end extending outside the body and a distal end extending inside the body.

65. The method of claim 64, wherein the distal end of the delivery device is configured to engage the heart.

66. The method of claim 65, wherein the distal end of the delivery device includes a suction member for engaging the heart and a vacuum device to create negative pressure in the suction member so that the suction member is releaseably attached to the heart.

67. The method of claim 66, wherein a syringe draws a vacuum to create the negative pressure in the suction member.

68. The method of claim 66, wherein after the suction member engages the heart and a negative pressure is drawn, the delivery device is slightly withdrawn proximally so that the heart at least partially elongates.

69. The method of claim 68, wherein the cardiac harness assembly is advanced distally out of the delivery device and onto the heart.

70. The method of claim 69, wherein prior to inserting the delivery device through the access site, making an incision in the pericardium so that the cardiac harness assembly is mounted on the epicardial surface of the heart and under the pericardium.

71. The method of claim 70, wherein the cardiac harness assembly advances distally out of the delivery device, over the suction member, and slides onto the epicardial surface of the heart.

72. The method of claim 71, wherein the negative pressure is released and the suction member disengages from the heart.

73. The method of claim 72, wherein the delivery device is withdrawn proximally from the access site.

74. The method of claim 60, wherein the at least one electrode is attached to a power source for providing electrical stimuli.

75. The method of claim 74, wherein the at least one electrode is a defibrillator electrode for providing a defibrillating shock to the heart.

76. The method of claim 74, wherein the at least one electrode is a pacing electrode for providing pacing therapy to the heart.

77. The method of claim 74, wherein the at least one electrode is a pacing/sensing electrode to provide pacing and sensing therapies to the heart.

78. The method of claim 74, wherein multiple electrodes are attached to the cardiac harness, and wherein at least some of the electrodes are defibrillating electrodes and at least some of the electrodes are pacing/sensing electrodes.

79. The method of claim 74, wherein the at least one electrode has a lead extending from a portion of the electrode near the apex of the heart to the power source.

80. The method of claim 60, wherein the delivery of the cardiac harness assembly to the heart is monitored by viewing any of magnetic resonance imaging (MRI), fluoroscopy and echocardiography.