Cardiac device and methods of use thereof

• US 8,672,827 B2
• Filed: 01/21/2010
• Issued: 03/18/2014
• Est. Priority Date: 08/09/1999
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Cardiokinetix Incorporated
• Inventors: Nikolic, Serjan D., Khairkhahan, Alexander
• Primary Examiner(s): GETZOW, SCOTT M
• Application Number:
  US12/691,587
• Publication Number:
  US 20100121132A1
• Time in Patent Office: 1,517 Days
• Field of Search: 600 16- 18, 600/37, 623 11- 242
• 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 ribs connected at their distal ends to a central hub, and a membrane coupled to the ribs, wherein the ribs are adapted to anchor to a wall of a ventricle of the heart to compress and store energy during systole and to self-expand during diastole to provide an elastic recoil force to the wall of the ventricle.

2. The device of claim 1, wherein the ribs are made of a resilient material to allow compression and expansion.

3. The device of claim 1, wherein the ribs are made of a NiTi alloy.

4. The device of claim 1, wherein the ribs are configured to curve away from a center line axis of the hub at least upon expansion of the recoil device.

5. The device of claim 4, wherein the ribs are configured to expand outwardly at an angle between about 20°

and about 90°

away from the center line axis.

6. The device of claim 1, further comprising at least three ribs.

7. The device of claim 1, further comprising anchoring elements on proximal ends of the ribs for anchoring the device to a selected area of the wall of the ventricle.

8. The device of claim 7, wherein the anchoring elements are spaced from one another in an expanded configuration to allow for positioning of the device at a select angle relative to the ventricle.

9. The device of claim 7, wherein the anchoring elements are configured to penetrate the wall to secure a peripheral edge of the device to the wall.

10. The device of claim 7, wherein the anchoring elements comprise a member selected from the group consisting of barbs, hooks, and a combination of the same.

11. The device of claim 7, wherein the anchoring elements are adapted to penetrate the wall at an angle between about 30°

and about 120°

from a center line axis of the device.

12. The device of claim 1, wherein the ribs are configured to curve away from a center line axis of the hub at least upon expansion of the recoil device to form a trumpet-shaped concave pressure receiving surface.

13. The device of claim 1, further comprising a stem connected to and extending distally from the central hub, wherein the stem is adapted to space the central hub of the device a selected distance from the wall of the ventricle.

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

15. The device of claim 14, wherein a distal end of the connector member includes feet adapted to distribute force over an expanded surface of a wall of the ventricle.

16. The device of claim 15, wherein the feet are interconnected by lateral supports.

17. The device of claim 16, wherein the feet and lateral supports are made of resilient material to support the device without causing trauma to the ventricle wall.

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

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

20. The device of claim 1, wherein an unconstrained diameter of the device is about 25 mm to about 100 mm.

21. The device of claim 1, further comprising a connector bar to permit selective deployment and release of the diastolic recoil device from a delivery catheter.

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

advancing percutaneously a collapsed diastolic recoil device comprising a plurality of expandable ribs connected at their distal ends to a central hub;

self-expanding the ribs in a ventricle of the heart;

securing the device to opposing walls of the ventricle thereby providing elastic support between the opposing ventricular walls; and

storing energy provided by the ventricle in the ribs during systole and providing a delayed elastic recoil force to the opposing walls of the ventricle from the ribs during diastole.

23. The method of claim 22, further comprising selectively releasing the device from a delivery catheter to cause the self-expanding.

24. The method of claim 22, wherein storing energy provided by the ventricle in the ribs during systole and providing an elastic recoil force comprises providing elastic recoil force to the opposing walls of the ventricle from the ribs at selected time intervals during filling of the ventricle.

25. The method of claim 22 wherein storing energy provided by the ventricle in the ribs during systole and providing an elastic recoil force comprises providing elastic recoil force during systole and delaying release of an elastic recoil force back to the walls of the ventricle until a selected point after diastole begins.

26. The method of claim 22, further comprising anchoring the device to a selected area of a wall of the ventricle.

27. The method of claim 22, further comprising penetrating at least one of the opposing walls to secure a peripheral edge of the device to the at least one wall.

28. The method of claim 22, further comprising partitioning the ventricle between a functional portion and a non-functional portion.

29. The method of claim 28, further comprising permanently sealing the device in the ventricle.

30. The method of claim 28, wherein the portioning comprises decreasing left ventricular volume by at least 10%.

31. The method of claim 28, wherein the portioning comprises decreasing minimum left ventricular pressure by at least about 5%.

32. The method of claim 22, further comprising improving ejection fraction of the ventricle by at least about 10%.

33. The method of claim 22, further comprising improving a pressure-volume relationship of the ventricle.

34. The method of claim 22, further comprising assisting in expansion of the ventricle.

35. The method of claim 22, wherein the collapsed diastolic recoil device further comprises an anchor element at a proximal end of each of the ribs, the method further comprising securing the device to a selected area of a wall of the ventricle with the anchor elements thereby augmenting a ventricular wall movement during diastole.

36. A method of treating a patient in need of more efficient diastolic filling, the method comprising:

advancing percutaneously a collapsed diastolic recoil device comprising a plurality of expandable ribs connected at their distal ends to a central hub and a stem connected to and extending distally from the central hub, wherein the stem is adapted to space the central hub of the device a selected distance from a wall of a ventricle, wherein the ribs are stiffened relative to healthy ventricular walls to augment ventricle wall movement during diastole;

self-expanding the ribs in the ventricle of the heart;

securing the device to opposing walls of the ventricle; and

compressing the plurality of ribs during systole and providing a corresponding elastic recoil force to the opposing walls during diastole.

37. A diastolic recoil device adapted for percutaneous delivery to a ventricle of a heart of a patient comprising a plurality of radially expandable ribs coupled at their distal ends to a central hub, wherein the ribs are adapted to augment ventricle wall movement during diastole, and to provide a recoil force to the ventricular walls at a selected point during diastole that is delayed from the onset of diastole.

38. 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 one or more anchor elements at each of the proximal ends of the ribs adapted to secure the device to a selected area of a wall within a ventricle of the heart, wherein the ribs are adapted to support the wall and decrease the stress in the wall thereby limiting remodeling of the heart, and a stem connected to and extending distally from the central hub, wherein the stem is adapted to space the central hub of the device a selected distance from the wall of the ventricle.

39. A diastolic recoil device adapted for percutaneous delivery to a heart of a patient comprising a plurality of radially expandable ribs connected at their distal ends to a central hub and a membrane coupled to the ribs, wherein the ribs are adapted to store energy and reduce diastolic pressure of a ventricle of the heart when disposed in the ventricle.

40. The device of claim 39, wherein the ribs are adapted to store the energy during systole and deliver a corresponding recoil force during diastole.

41. The device of claim 40, further comprising a spring mechanism to delay delivery of the recoil force until a selected point after diastole begins.

42. A method of treating a heart of a patient comprising:

advancing percutaneously a collapsed diastolic recoil device comprising a plurality of radially expandable ribs connected at their distal ends to a central hub and having an anchor element at a proximal end of each of the ribs and a membrane coupled to the expandable ribs;

allowing the ribs to self-expand in a ventricle of the heart; and

securing the device to a selected area of a wall of the ventricle with the anchor elements thereby reducing diastolic pressure of the ventricle of the heart.

43. A diastolic recoil device adapted for percutaneous delivery to a heart of a patient comprising:

a plurality of radially expandable ribs connected at their distal ends to a central hub;

a stem connected to and extending distally from the central hub, wherein the stem is adapted to space the central hub of the device a selected distance from a wall of a ventricle; and

a plurality of anchor elements attached to a plurality of the ribs at their proximal ends,

the anchor elements being adapted to secure the device to the wall of the ventricle of the heart; and

wherein the device is adapted to reduce a volume of the ventricle to improve a pressure-volume relationship of the ventricle of the heart.

44. A diastolic recoil device comprising a plurality of radially expandable ribs connected at their distal ends to a central hub and a membrane coupled to the ribs, the 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 the ventricle, the radially expandable ribs being adapted to deform from a first shape to a second shape during systole and to return to the first shape a selected point after diastole begins to assist in expansion of the ventricle.

45. The device of claim 44, further comprising anchor elements on proximal ends of the ribs for anchoring the device to a selected area of a wall of the ventricle.

46. The device of claim 44, further comprising a contact member extending distally from the central hub along a central longitudinal axis of the device, wherein the contact member is adapted to space the central hub of the device a selected distance from a wall of the ventricle.

47. The device of claim 44, further comprising a delayed release spring mechanism adapted to release an elastic recoil force back to the wall of the ventricle at a selected time intervals during diastole.