Devices and methods for heart valve treatment

• US 20030233022A1
• Filed: 06/09/2003
• Published: 12/18/2003
• Est. Priority Date: 06/12/2002
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Inventors: Vidlund, Robert M., Mortier, Todd J., Schweich, Cyril J. Jr., Ekvall, Craig A., Schroeder, Richard, Kalgreen, Jason E., LaPlante, Jeffrey P.
• Application Number:
  US10/456,751
• Publication Number:
  US 20030233022A1
• Time in Patent Office: Days
• US Class Current: 600/16
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints

Abstract

Devices, systems and methods for improving the function of a valve of a heart by implanting the device adjacent the valve such that the device indirectly applies a force to the valve and increases coaptation of the leaflets, or otherwise improves valve function. The device may be implanted in a position that does not directly contact the valve structures. The force may be applied to a wall of the heart, and the force may be an inward force applied to two walls of the heart, such as the left ventricular free wall and the ventricular septum, or the left ventricular free wall and the right ventricular free wall, to improve mitral valve function.

Claims

1. A device for improving the function of a heart, the device comprising:

an elongate member configured to be positioned transverse a chamber of the heart; and

a release mechanism connected to the elongate member, the release mechanism being configured to releasably engage with each of a plurality of anchoring members having differing configurations to releasably attach the elongate member to each of the plurality of anchoring members one at a time.

2. The device of claim 1, wherein each of the plurality of anchoring members defines a recess configured to receive the release mechanism.

3. The device of claim 2, wherein the recess is configured to receive the release mechanism when the release mechanism is in a first position.

4. The device of claim 3, further comprising a projection defining a portion of the recess, the projection being configured to prevent passage of the release mechanism through each of the plurality of anchoring members when the release mechanism is in the first position.

5. The device of claim 4, wherein the projection defines an opening configured to permit passage of the release mechanism therethrough when the release mechanism is in a second position.

6. The device of claim 2, wherein the release mechanism is in the form of a block.

7. The device of claim 1, wherein the release mechanism is moveable relative to the elongate member.

8. The device of claim 7, wherein the release member is configured to articulate relative to the elongate member.

9. The device of claim 1, wherein the release member is moveable between a first position wherein the release mechanism is releasable from each of the plurality of anchoring members and a second position wherein the release mechanism is engageable with each of the plurality of anchoring members.

10. The device of claim 1, further comprising at least one of the plurality of anchoring members having differing configurations.

11. The device of claim 10, further comprising an additional anchoring member for securing the elongate member relative to the heart, the additional anchoring member being configured to be attached to the elongate member.

12. The device of claim 11, wherein the at least one anchoring member is configured to be connected to the elongate member at a first end of the elongate member and the additional anchoring member is configured to be attached to the elongate member at a second end of the elongate member.

13. The device of claim 11, wherein the at least one anchoring member is configured to be positioned on a posterior side of a mitral valve and wherein the additional anchoring member is configured to be positioned on an anterior side of the mitral valve.

14. The device of claim 13, wherein each of the at least one anchoring member and the additional anchoring member is configured to be positioned on an exterior surface of a wall of the heart.

15. The device of claim 10, wherein the at least one anchoring member comprises a first contact zone and a second contact zone, the first and second contact zones being configured to rest on an exterior surface of a wall of the heart.

16. The device of claim 15, wherein the at least one anchoring member further comprises a bridge connecting the first contact zone and the second contact zone.

17. The device of claim 15, wherein the first contact zone is configured to be positioned adjacent an annulus of a mitral valve and wherein the second contact zone is configured to be positioned approximately at a level of papillary muscles of the mitral valve.

18. The device of claim 17, wherein the first contact zone is configured to be positioned on a posterior side of the annulus.

19. The device of claim 16, wherein the bridge defines a recess configured to receive the release mechanism.

20. The device of claim 10, further comprising a covering on at least a portion of the at least one anchoring member.

21. The device of claim 20, wherein the covering is configured to facilitate tissue ingrowth.

22. The device of claim 1, wherein the plurality of differing anchoring members include anchoring members having differing sizes and/or shapes.

23. The device of claim 1, wherein the device is configured to improve valve function.

24. The device of claim 1, wherein the chamber is a left ventricle.

25. A method for improving the function of a heart, the method comprising:

providing a plurality of anchoring members having differing configurations;

providing an elongate member and a release mechanism connected to the elongate member, the release mechanism being configured to releasably engage with each of the plurality of anchoring members;

selecting one of the plurality of anchoring members;

positioning the elongate member transverse a chamber of the heart; and

engaging the release mechanism with the selected anchoring member so as to releasably attach the elongate member to the selected anchoring member.

26. A method of delivering a device to be positioned relative to a heart chamber, the method comprising:

providing an elongate member having a first end and a second end, the second end having an expandable anchoring member attached thereto;

advancing the first end of the elongate member through a first heart wall, a septal wall, and a second heart wall substantially opposite the septal wall such that the elongate member extends substantially transverse a heart chamber; and

expanding the expandable anchoring member such that the expandable anchoring member prevents the second end of the elongate member from being able to pass through the septal wall and into the heart chamber.

27. The method of claim 26, wherein the expanding the expandable anchoring member includes inflating the expandable anchoring member.

28. The method of claim 27, wherein the inflating the expandable anchoring member includes filling the expandable anchoring member with a curable substance.

29. The method of claim 28, further comprising connecting an injection mechanism to the expandable anchoring member to fill the expandable anchoring member with a curable substance.

30. The method of claim 26, wherein the expandable anchoring member is a self-expandable anchoring member and expanding the self-expandable anchoring member includes allowing the anchoring member to self-expand.

31. The method of claim 30, wherein allowing the anchoring member to self-expand includes removing the expandable anchor from a housing containing the expandable anchor.

32. The method of claim 31, wherein the housing is defined by a delivery probe.

33. The method of claim 26, wherein the advancing the elongate member includes advancing the elongate member until the expandable anchor is in a heart chamber surrounded by the first wall and the septal wall.

34. The method of claim 33, wherein the advancing the elongate member includes advancing the elongate member with the expandable anchor in a collapsed configuration.

35. The method of claim 26, further comprising attaching an additional anchoring member to the first end of the elongate member.

36. The method of claim 35, wherein the attaching the additional anchoring member includes attaching the additional anchoring member such that the elongate member is in tension.

37. The method of claim 26, wherein the heart chamber is a left ventricle.

38. A device for securing an elongate member in a position transverse at least one heart chamber, the device comprising:

an anchor assembly configured to be secured to the elongate member, the anchor assembly having a collapsed configuration and an expanded configuration and comprising

a first arm,

a second arm, and

at least one biasing member connecting the first arm and the second arm,

wherein, in the absence of external force, the biasing member is configured to exert a biasing force on the first arm and the second arm such that the anchor assembly is in the expanded configuration.

39. The device of claim 38, wherein the at least one biasing member includes two biasing members.

40. The device of claim 39, wherein one of the biasing members connects first end portions of the first arm and the second arm to each other and the other of the biasing members connects second end portions of the first arm and the second arm to each other.

41. The device of claim 38, wherein the first arm and the second arm are substantially perpendicular to each other when the anchor assembly is in the expanded configuration.

42. The device of claim 38, wherein the first arm and the second arm are substantially parallel to each other when the anchor assembly is in the collapsed configuration.

43. The device of claim 38, wherein the first arm is configured to nest in the second arm when the anchor assembly is in the collapsed configuration.

44. The device of claim 43, wherein the first arm has a substantially circular cross-section and the second arm has a substantially parabolic cross-section.

45. The device of claim 38, wherein the at least one biasing member is a spring.

46. The device of claim 38, wherein the biasing member is made of spring tempered stainless steel.

47. The device of claim 38, wherein the first arm and the second arm are pivotable relative to each other.

48. The device of claim 47, wherein the first arm and the second arm are pivotably connected via the elongate member.

49. An alignment device comprising:

an arm; and

a tissue engaging member configured to engage a tissue surface connected to the arm, the tissue engaging member comprising

a cover defining a cover opening, and

a rotatable insert defining a plurality of openings configured to be individually aligned with the cover opening by rotating the insert with respect to the cover,

wherein, when the cover opening and one of the plurality of openings are aligned, the cover opening and one of the plurality of openings are configured to receive a needle assembly.

50. The alignment device of claim 49, wherein the tissue engaging member further comprises a vacuum chamber.

51. The alignment device of claim 49, wherein a first sloped surface leads to the cover opening and second sloped surfaces lead to the plurality of openings.

52. The alignment device of claim 49, further comprising a plate, the plate defining a plurality of receiving portions configured to align with the plurality of openings in the rotatable insert.

53. The alignment device of claim 52, wherein the rotatable insert is disposed between the plate and the cover.

54. The alignment device of claim 52, wherein each of the plurality of receiving portions is configured to capture the needle assembly once a tip portion of the needle assembly has been advanced into the receiving portion.

55. The alignment device of claim 54, wherein each of the plurality of receiving portions defines at least one opening configured to allow passage of the needle assembly in a first direction.

56. The alignment device of claim 55, wherein each of the plurality of receiving portions further includes at least one tab configured to engage a detent in the needle assembly.

57. The alignment device of claim 56, wherein the at least one tab is configured to prevent the needle assembly from passage through the at least one opening in a second direction opposite to the first direction.