Heart wall tension reduction apparatus and method

• US 6,045,497 A
• Filed: 07/29/1998
• Issued: 04/04/2000
• Est. Priority Date: 01/02/1997
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Myocor, Inc. (Edwards Lifesciences Corporation)
• Inventors: Vidlund, Robert M., Keith, Peter T., Mortier, Todd J., Schweich, Cyril J. Jr., Paulson, Thomas M.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US09/124,286
• Time in Patent Office: 615 Days
• Field of Search: 600/16-18, 600/37, 601/11, 623/3, 623/11, 128/897, 128/898
• 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 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/1227 Spring clips
• 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 2017/0435 the barbs being separate elements mechanically linked to the anchor, e.g. by pivots
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0446 Means for attaching and blocking the suture in the suture anchor
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0461 with features cooperating with special features on the suture, e.g. protrusions on the suture
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61F 2/2487 : Devices within the heart chamber, e.g. splints

Abstract

An apparatus for treatment of a failing heart by reducing the wall tension therein. In one embodiment, the apparatus includes a tension member for drawing at least two walls of a heart chamber toward each other. Methods for placing the apparatus on the heart are also provided.

Claims

1. A transventricular splint, comprising:

an elongate tension member having two axially disposed ends; and

a substantially atraumatic anchor having a disc-like shape disposed at each end, such that the length of the tension member between the anchors is about 1 to 4 inches.

2. The transventricular splint in accordance with claim 1, wherein the tension member comprises a multi-filament elongate member.

3. The transventricular splint in accordance with claim 1, wherein the tension member is substantially radiopaque.

4. The transventricular splint in accordance with claim 1, further comprising a radiopaque marker disposed on the tension member.

5. The transventricular splint in accordance with claim 1, wherein the tension member is echo cardiograph compatible.

6. The transventricular splint in accordance with claim 1, further comprising an echogenic marker disposed on the tension member.

7. The transventricular splint in accordance with claim 1, wherein the tension member has a substantially antithrombogenic surface.

8. The transventricular splint in accordance with claim 7, wherein the tension member has a substantially antithrombogenic coating.

9. The transventricular splint in accordance with claim 1, wherein the tension member has a length of between about 0.6 and 2.0 inches.

10. The transventricular splint in accordance with claim 1, wherein the tension member has a diameter of between about 0.01 and 0.02 inches.

11. An apparatus for placement in a heart, the apparatus comprising:

an elongate, multifilament member having opposite ends; and

an anchor having a disc-like shape disposed at each end to engage a wall of the heart so that the engaged walls remain in a non-contacting relationship.

12. The apparatus of claim 11, wherein the member is formed essentially of stainless steel.

13. The apparatus of claim 11, wherein the member is formed essentially of a titanium alloy.

14. The apparatus of claim 11, wherein the member is formed essentially of a nickel titanium alloy.

15. The apparatus of claim 11, wherein the member is formed essentially of a shape memory alloy.

16. The apparatus of claim 11, wherein the member has a diameter in the range of approximately 0.005 inches to 0.035 inches.

17. The apparatus of claim 11, wherein the member has a length in the range of approximately 0.6 inches to 4 inches.

18. The apparatus of claim 11, wherein the member is braided wire.

19. The apparatus of claim 11, wherein the member is twisted wire.

20. The apparatus of claim 11, wherein the member is formed essentially of polymeric fiber.

21. The apparatus of claim 11, wherein the member is formed essentially of carbon fiber.

22. The apparatus of claim 11, wherein the member includes a coating.

23. The apparatus of claim 22, wherein the coating is formed essentially of silicone.

24. The apparatus of claim 22, wherein the coating is formed essentially of urethane.

25. The apparatus of claim 22, wherein the coating is formed essentially of PTFE.

26. The apparatus of claim 22, wherein the coating is formed essentially of carbon.

27. The apparatus of claim 22, wherein the coating includes a drug.

28. The apparatus of claim 22, wherein the coating is ingrowth inducing.

29. The apparatus of claim 28, wherein the coating is formed essentially of collagen.

30. The apparatus of claim 11, wherein the member includes a core fiber extending along an axis of the member.

31. The apparatus of claim 11, wherein the member is radiopaque.

32. The apparatus of claim 11, wherein the member is echo cardiograph compatible.

33. The apparatus of claim 11, wherein the member is MRI compatible.

34. The apparatus of claim 11, wherein the member includes a radiopaque marker.

35. The apparatus of claim 11, wherein the member includes an echo cardiograph compatible marker.

36. The apparatus of claim 11, wherein the member includes an MRI compatible marker.

37. The apparatus of claim 11, wherein the member is configured to extend transverse the left ventricle of the heart and avoid papillary muscles and arteries.

38. An apparatus for placement in a heart, the apparatus comprising:

an elongate member having opposite ends; and

an anchor disposed at each end to engage a wall of the heart, the anchor being capable of articulating relative to the member.

39. The apparatus of claim 38, wherein each anchor includes a recess for receiving a corresponding end of the member.

40. The apparatus of claim 39, wherein the corresponding end of the member includes a ball.

41. The apparatus of claim 38, wherein the member is a multifilament member.

42. The apparatus of claim 38, wherein each anchor includes a socket for receiving a ball at a corresponding end of the member.

43. An apparatus for placement in a heart, the apparatus comprising:

an elongate member having opposite ends; and

an anchor disposed at each end to engage a wall of the heart so that the engaged walls remain in a non-contacting relationship, the anchor including a mechanism capable of securing the member to the anchor.

44. The apparatus of claim 43, wherein the mechanism includes a collet disposed within an orifice of the anchor to receive the member.

45. The apparatus of claim 44, wherein the collet is threaded to receive a nut.

46. The apparatus of claim 43, wherein the anchor includes an aperture having sloping sides.

47. The apparatus of claim 43, wherein the mechanism includes a set screw disposed within a passage of the anchor.

48. The apparatus of claim 43, wherein the mechanism includes a pair of cantilever members capable of clamping the member.

49. The apparatus of claim 43, wherein the anchor is formed essentially of a stainless steel alloy.

50. The apparatus of claim 43, wherein the anchor is formed essentially of a titanium alloy.

52. The apparatus of claim 43, wherein the anchor is capable of articulating relative to the member to reduce bending of the member.

53. The apparatus of claim 43, wherein the member is configured to extend transverse the left ventricle of the heart and avoid papillary muscles and arteries.

51. An apparatus for placement in a heart, the apparatus comprising:

an elongate member having opposite ends; and

an anchor having a disc-like shape disposed at each end to engage a wall of the heart so that the engaged walls remain in a noncontacting relationship, the anchor including a mechanism capable of securing the anchor to the wall.

54. An apparatus for placement in a heart, the apparatus comprising:

an elongate member having opposite ends; and

an anchor disposed at each end to engage a wall of the heart so that the engaged walls remain in a non-contacting relationship, the anchor including a mechanism capable of securing the anchor to the wall.

55. The apparatus of claim 54, wherein the mechanism includes a biocompatible adhesive.

56. The apparatus of claim 54, wherein the mechanism includes an aperture extending through the anchor, the aperture configured to receive a suture for securing the anchor to the wall.

57. The apparatus of claim 54, wherein the mechanism includes an aperture extending through the anchor, the aperture being threaded to receive a screw for securing the anchor to the wall.

58. The apparatus of claim 54, wherein the mechanism includes a layer of material capable of promoting tissue ingrowth.

59. The apparatus of claim 58, wherein the material is a mesh material.

60. The apparatus of claim 58, wherein the material is formed essentially of PTFE.

61. The apparatus of claim 58, wherein the anchor includes a top layer of material connected to the layer of tissue ingrowth material.

62. The apparatus of claim 61, wherein the top layer is formed essentially of PTFE.

63. The apparatus of claim 54, wherein the member is a multifilament member.

64. The apparatus of claim 54, wherein the anchor is capable of articulating relative to the member to reduce bending of the member.

65. The apparatus of claim 54, wherein the member is configured to extend transverse the left ventricle of the heart and avoid papillary muscles and arteries.

66. The apparatus of claim 54, wherein the anchor includes a second mechanism capable of securing the member to the anchor.