Cardiac device and methods of use thereof

• US 7,674,222 B2
• Filed: 12/14/2006
• Issued: 03/09/2010
• Est. Priority Date: 08/09/1999
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Cardiokinetix Incorporated
• Inventors: Nikolic, Serjan, Khairkhahan, Alexander
• Primary Examiner(s): Getzow; Scott M
• Application Number:
  US11/640,469
• Publication Number:
  US 20070161846A1
• Time in Patent Office: 1,181 Days
• Field of Search: 623 11- 242, 600 16- 18, 600/37
• US Class Current: 600/16
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence

Abstract

Devices and methods are described herein which are directed to the treatment of a patient'"'"'s heart having, or one which is susceptible to heart failure, to improve diastolic function.

Claims

1. A diastolic recoil device adapted for percutaneous delivery to a heart of a patient comprising a plurality of radially expandable resilient ribs connected at their distal ends to a central hub, and a membrane coupled to said ribs, wherein said ribs are adapted to anchor to a wall of a ventricle of said heart to store energy provided by said ventricle during systole and to provide an elastic recoil force to said wall of said ventricle during diastole.

2. The device of claim 1 further comprising anchor elements on proximal ends of said ribs for anchoring said device to a selected area of said wall of said ventricle.

3. The device of claim 1 further comprising a contact member extending distally from said central hub along a central longitudinal axis of said device, wherein said contact member is adapted to space said central hub of said device a selected distance from a wall of said ventricle.

4. The device of claim 3 wherein said contact member is adapted to contact said wall atraumatically.

5. The device of claim 3 wherein said contact member comprises an atraumatic distal end adapted to distribute pressure against said wall.

6. The device of claim 1 further comprising a hollow connector member extending proximally from said central hub along a central longitudinal axis of said device wherein said connector member is adapted for releasable connection to a delivery catheter.

7. The device of claim 1 further comprising a delayed release spring mechanism adapted to release said elastic recoil force back to said wall of said ventricle at a selected point during diastole.

8. The device of claim 1 wherein an unconstrained diameter of said device is oversized by at least about 10% up to about 60% over a landing zone diameter of said ventricle at end diastole.

9. The device of claim 1 wherein an unconstrained diameter of said device is about 25 mm to about 100 mm.

10. The device of claim 1 further comprising a ring coupled to said ribs near proximal ends of said ribs for sealing said membrane to said wall.

11. A method of treating a patient suffering from a heart condition comprising:

advancing percutaneously a collapsed diastolic recoil device comprising a plurality of radially expandable resilient ribs connected at their distal ends to a central hub, said device further comprising a membrane coupled to said ribs;

expanding said ribs in a ventricle of said heart;

partitioning said ventricle with said membrane; and

,

securing said device to opposing walls of said ventricle thereby providing elastic support between said opposing ventricular walls.

12. The method of claim 11 further comprising storing energy provided by said ventricle in said ribs during systole and providing an elastic recoil force to said opposing walls of said ventricle from said ribs during diastole.

13. The method of claim 11 wherein said ribs further comprise anchor elements on proximal ends of said ribs, the method further comprising anchoring said device to a selected area of a wall of said ventricle.

14. The method of claim 11 further comprising spacing said central hub a selected distance from a wall of said ventricle.

15. The method of claim 11 further comprising releasing said device from a delivery catheter.

16. The method of claim 11 further comprising delaying release of an elastic recoil force back to said walls of said ventricle until a selected point after diastole begins.

17. The method of claim 11 wherein an unconstrained diameter of said device is oversized by at least about 10% up to about 60% greater than a landing zone diameter of said ventricle at end diastole.

18. The method of claim 17 wherein said unconstrained diameter of said device is about 25 mm to about 100 mm.

19. The method of claim 11 further comprising restoring overall synchrony in the cardiac cycle.

20. The method of claim 11 further comprising improving ejection fraction of said ventricle by at least about 10%.

21. The method of claim 11 further comprising augmenting movement of said walls of said ventricle during diastole.

22. The method of claim 11 further comprising decreasing stress in said walls of said ventricle, thereby limiting remodeling of said heart.

23. The method of claim 11 further comprising reducing diastolic pressure of said ventricle.

24. The method of claim 11 further comprising improving a pressure-volume relationship of said ventricle.

25. The method of claim 11 further comprising assisting in expansion of said ventricle.

26. The method of claim 11 further comprising supporting a weakened cardiac wall.

27. The method of claim 11 further comprising decreasing left ventricular volume by at least 10%.

28. The method of claim 11 further comprising decreasing minimum left ventricular pressure by at least about 5%.

29. The method of claim 11 further comprising decreasing end-diastolic pressure of said ventricle by at least about 5%.

30. The method of claim 11 further comprising decreasing left ventricle end systolic volume index of said patient by at least about 5%.

31. The method of claim 11 further comprising decreasing the level of NT-Pro-Brain Natriuretic Peptide by at least about 10%.

32. The method of claim 11 further comprising decreasing regurgitant fraction in a patient having mitral valve regurgitation by at least about 10%.

33. The method of claim 11 further comprising sealing said membrane to said walls.

34. A diastolic recoil device comprising a plurality of resiliently deformable ribs and a plurality of anchors, and a membrane coupled to said ribs, said device being adapted to be delivered percutaneously to and anchored within the interior of a ventricle of a patient'"'"'s heart to span a region of said ventricle, said resiliently deformable member being adapted to deform from a first shape to a second shape during systole and to return to said first shape during diastole to assist in expansion of said ventricle.

35. The device of claim 34 further comprising anchor elements on proximal ends of said ribs for anchoring said device to a selected area of a wall of said ventricle.

36. The device of claim 34 further comprising a contact member extending distally from said central hub along a central longitudinal axis of said device, wherein said contact member is adapted to space said central hub of said device a selected distance from a wall of said ventricle.

37. The device of claim 36 wherein said contact member is adapted to contact said wall atraumatically.

38. The device of claim 36 wherein said contact member comprises an atraumatic distal end adapted to distribute pressure against said wall.

39. The device of claim 34 further comprising a hollow connector member extending proximally from said central hub along a central longitudinal axis of said device wherein said connector member is adapted for releasable connection to a delivery catheter.

40. The device of claim 34 further comprising a delayed release spring mechanism adapted to release an elastic recoil force back to said wall of said ventricle at a selected point during diastole.

41. The device of claim 34 wherein an unconstrained diameter of said device is oversized by at least about 10% up to about 60% over a landing zone diameter of said ventricle at end diastole.

42. The device of claim 34 wherein an unconstrained diameter of said device is about 25 mm to about 100 mm.

43. The device of claim 34 further comprising a ring coupled to said ribs near proximal ends of said ribs for sealing said membrane to a wall of said ventricle.

44. A method of treating a patient suffering from a heart condition comprising:

advancing percutaneously to the interior of a ventricle of the patient'"'"'s heart a diastolic recoil device comprising a resiliently deformable member and a plurality of anchors;

securing said devices to opposing wall sections of said ventricle with said anchors;

deforming said deformable member as said opposing wall sections move toward each other during systole; and

providing a recoil force from said deformable member to said wall sections during diastole.

45. The method of claim 44 further comprising storing energy provided by said ventricle in said deformable member during systole and providing an elastic recoil force to said wall sections of said ventricle from said deformable member during diastole.

46. The method of claim 44 wherein said device further comprises a membrane coupled to said deformable member, the method further comprising partitioning said ventricle with said membrane.

47. The method of claim 46 further comprising sealing said membrane to said wall sections.

48. The method of claim 44 further comprising releasing said device from a delivery catheter.

49. The method of claim 44 further comprising delaying release of said recoil force back to said walls of said ventricle until a selected point after diastole begins.

50. The method of claim 44 wherein an unconstrained diameter of said device is oversized by at least about 10% up to about 60% greater than a landing zone diameter of said ventricle at end diastole.

51. The method of claim 50 wherein said unconstrained diameter of said device is about 25 mm to about 100 mm.

52. The method of claim 44 further comprising restoring overall synchrony in the cardiac cycle.

53. The method of claim 44 further comprising improving ejection fraction of said ventricle by at least about 10%.

54. The method of claim 44 further comprising augmenting movement of said wall sections of said ventricle during diastole.

55. The method of claim 44 further comprising decreasing stress in said wall sections of said ventricle, thereby limiting remodeling of said heart.

56. The method of claim 44 further comprising reducing diastolic pressure of said ventricle.

57. The method of claim 44 further comprising improving a pressure-volume relationship of said ventricle of said heart.

58. The method of claim 44 further comprising assisting in expansion of said ventricle.

59. The method of claim 44 further comprising supporting a weakened cardiac wall.

60. The method of claim 44 further comprising decreasing left ventricular volume by at least 10%.

61. The method of claim 44 further comprising decreasing minimum left ventricular pressure by at least about 5%.

62. The method of claim 44 further comprising decreasing end-diastolic pressure of said ventricle by at least about 5%.

63. The method of claim 44 further comprising decreasing left ventricle end systolic volume index of said patient by at least about 5%.

64. The method of claim 44 further comprising decreasing the level of NT-Pro-Brain Natriuretic Peptide by at least about 10%.

65. The method of claim 44 further comprising decreasing regurgitant fraction in a patient having mitral valve regurgitation by at least about 10%.

66. A method of treating a patient suffering from a heart condition comprising:

advancing percutaneously to the interior of a ventricle of the patient'"'"'s heart a diastolic recoil device comprising a resiliently deformable member and a plurality of anchors;

securing said device to opposing wall sections of said ventricle with said anchors;

storing energy within said deformable member as said opposing wall sections move toward each other during systole; and

releasing energy from said deformable member to said wall sections as said opposing wall sections move away from each other in synchrony with a heart cycle.

67. A method for increasing ejection fraction of the ventricular chamber, comprising:

inserting an energy storage element into the ventricular chamber storing mechanical energy in the energy storage element during systole of the ventricular chamber and releasing mechanical energy from the energy storage element during diastole of the ventricular chamber.

68. The method of claim 67, wherein storing energy comprises resiliently compressing the energy storage element.

69. The method of claim 67, wherein releases energy comprises resiliently expanding the energy storage element.

70. The method of claim 67, further comprising connecting a resilient cover to a first end of the energy storage element.

71. A device for increasing ejection fraction of a ventricular chamber, comprising:

an energy storage element configured to be deployed into the ventricular chamber wherein the energy storage element is configured to store mechanical energy by compressing the energy storage element during systole of the ventricular chamber

and release mechanical energy during diastole of the ventricular chamber.

72. The device of claim 71, wherein the energy storage element is resilient.

73. The device of claim 71, further comprising a cover connected to a first end of the energy storage element.