Methods and apparatus for controlling the internal circumference of an anatomic orifice or lumen

• US 9,492,276 B2
• Filed: 03/27/2006
• Issued: 11/15/2016
• Est. Priority Date: 03/25/2005
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Lee, Leonard Y., Fann, James I., Cartledge, Richard G.
• Primary Examiner(s): Sharma, Yashita
• Assistant Examiner(s): PRESTON, REBECCA STRASZHEIM
• Application Number:
  US11/390,984
• Publication Number:
  US 20060241748A1
• Time in Patent Office: 3,886 Days
• Field of Search: 623/2.37
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/086 having flexible threads, filaments, laces or wires, e.g. parallel threads, extending laterally from a strip, e.g. for tying to opposing threads extending from a similar strip
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/2472 Devices for testing
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0015 Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2230/0095 Saddle-shaped
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0082 specially designed for children, e.g. having means for adjusting to their growth

Abstract

An implantable device is provided for controlling at least one of shape and size of an anatomical structure or lumen. An implantable device has an adjustable member configured to adjust the dimensions of the implantable device. An adjustment tool is configured to actuate the adjustable member and provide for adjustment before, during and after the anatomical structure or lumen resumes near normal to normal physiologic function.

Claims

1. An apparatus for controlling at least one of a shape and size of an anatomical structure or lumen, the apparatus comprising:

an implantable annuloplasty ring including a hollow member forming an elongated opening therethrough, an elongated flexible member extending through the opening and a spindle, a portion of the flexible member coupled to the spindle, wherein the spindle is configured so that rotation of the spindle in a first direction causes the flexible member to wrap around the spindle and rotation of the spindle in a second direction causes the flexible member to unwrap from the spindle thereby changing at least one of a shape and size of the annuloplasty ring; and

an adjustment tool configured to effect rotation of the spindle, wherein the annuloplasty ring includes an engaging member for engaging the adjustment tool.

2. The apparatus of claim 1, wherein the adjustment tool is configured to be attachable and re-attachable to the engaging member.

3. The apparatus of claim 1, wherein the annuloplasty ring is configured to contract when the spindle is rotated in the first direction and the annuloplasty ring is configured to expand when the spindle is rotated in the second direction.

4. The apparatus of claim 3, wherein the annuloplasty ring is configured so that contraction of the annuloplasty ring causes contraction of the anatomical structure or lumen and expansion of the annuloplasty ring causes expansion of the anatomical structure or lumen.

5. The apparatus of claim 1, wherein the adjustment tool is configured to be removed from the annuloplasty ring after an adjustment of the anatomical structure or lumen is deemed satisfactory without having to reopen or access the anatomical structure or lumen.

6. The apparatus of claim 1, wherein the annuloplasty ring is adjustable in at least two dimensions upon rotation of the spindle.

7. The apparatus of claim 1, further comprising a locking mechanism to prevent the spindle from rotating.

8. The apparatus of claim 1, wherein the hollow member comprises at least an outer layer.

9. The apparatus of claim 8, wherein the flexible member is disposed within the outer layer.

10. The apparatus of claim 8, wherein the annuloplasty ring includes an intermediate layer adjacent to the outer layer, wherein the intermediate layer creates space for additional elements.

11. The apparatus of claim 1, wherein the annuloplasty ring is generally circular in shape.

12. The apparatus of claim 1, further comprising:

one or more fastening devices configured to provide fastening of the annuloplasty ring to the anatomical structure or lumen.

13. The apparatus of claim 12, wherein the one or more fastening devices are incorporated in the annuloplasty ring.

14. The apparatus of claim 12, wherein the one or more fastening devices are selected from at least one of a suture, wire, retention barbs and a shape memory apparatus.

15. The apparatus of claim 12, wherein the one or more fastening devices are clips.

16. The apparatus of claim 15, wherein the clips are made of a shape memory material.

17. The apparatus of claim 15, wherein the clips are from approximately 4 mm to approximately 10 mm in length.

18. The apparatus of claim 15, wherein the clips are configured to have a retracted state in which the clips are substantially straight and lie adjacent a lower face of the annuloplasty ring.

19. The apparatus of claim 18, wherein the clips are configured to have a normal configuration in which free ends of the clips curve into overlapping barbs.

20. The apparatus of claim 19, wherein the clips assume the normal configuration when released from the retracted state.

21. The apparatus of claim 15, wherein the clips are anchored to the annuloplasty ring by at least one of, stitching, adhesive, heat fusion, eyelets and by being woven into the annuloplasty ring.

22. The apparatus of claim 12, wherein the one or more fastening devices are coupled to an outer perimeter of the annuloplasty ring.

23. The apparatus of claim 12, wherein the one or more fastening devices are arranged at different locations on the annuloplasty ring.

24. The apparatus of claim 12, wherein the one or more fastening devices are retractable.

25. The apparatus of claim 12, wherein the one or more fastening devices are extendable.

26. The apparatus of claim 25, wherein the one or more fastening devices are not extended until the annuloplasty ring is properly oriented with respect to the anatomical orifice or lumen.

27. The apparatus of claim 1, wherein the flexible member comprises a continuous flexible band.

28. The apparatus of claim 1, wherein the flexible member is made of a shape memory material.

29. The apparatus of claim 1, wherein the spindle is substantially cylindrical.

30. The apparatus of claim 1, wherein the annuloplasty ring is configured to be adjusted after a patient'"'"'s anatomical structure or lumen has resumed normal physiology.

31. The apparatus of claim 1, wherein the annuloplasty ring is configured to be adjusted after resumption of blood flow through a patient'"'"'s heart.

32. The apparatus of claim 1, wherein the annuloplasty ring is releaseably attached to a delivery device for the annuloplasty ring.

33. The apparatus of claim 1, wherein the adjustment tool is configured to be advanced toward the anatomical structure or lumen through a catheter.

34. The apparatus of claim 1, wherein the adjustment tool includes at least one of, a magnetic, electronic, electromagnetic, and laser-guided device to allow attachment of the adjustment tool to the annuloplasty ring.

35. The apparatus of claim 1, wherein the adjustment tool is configured to be driven by a system that is remotely controlled.

36. The apparatus of claim 1, wherein the annuloplasty ring is configured to provide uniform and non-uniform adjustment of the anatomical structure or lumen.

37. The apparatus of claim 1, wherein the annuloplasty ring is configured to provide adjustment to a mitral valve.

38. The apparatus of claim 1, wherein at least a portion of the hollow member comprises a tubular structure.

39. The apparatus of claim 1, wherein the annuloplasty ring includes an interface that provides for a suture-less attachment of the annuloplasty ring to the anatomical structure or lumen.

40. The apparatus of claim 1, further comprising sutures to affix the annuloplasty ring to the anatomical structure or lumen.

41. The apparatus of claim 1, further including a biologically-compatible substance adapted to help secure the annuloplasty ring to the anatomical structure or lumen.

42. The apparatus of claim 1, wherein the spindle is arranged in communication with the opening, the spindle having a portion of the flexible member wrapped thereabout.

43. An apparatus for controlling at least one of a shape and size of an anatomical structure or lumen, the apparatus comprising:

an implantable annuloplasty ring comprising a hollow member forming an elongated opening therethrough, a winch having a rotatable spindle and an elongated flexible member of adjustable length extending through the opening and having a portion wrapped about the spindle, wherein rotation of the spindle in a first direction causes the member to be taken up by the spindle thereby shortening the member within the hollow member, and wherein rotation of the spindle in a second direction causes the member to be let out thereby lengthening the member within the hollow member, wherein the ring is configured to have at least one of an adjustable size or shape responsive to the shortening or lengthening of the flexible member; and

an adjustment tool configured to be removeably coupled to the spindle for rotation thereof.

44. The apparatus of claim 43, wherein the flexible member comprises a continuous flexible band.

45. An apparatus for controlling at least one of a shape and size of an anatomical structure or lumen, the apparatus comprising:

an adjustable ring shaped implantable device including an elongated hollow member defining an elongated opening;

an elongated flexible member extending through the opening;

a spindle in communication with the opening configured for rotation in a first and second direction, a portion of the flexible member wrapped about the spindle, the extent of the wrapping of the flexible member about the spindle increasing upon rotation of the spindle in the first direction and decreasing upon rotation of the spindle in the second direction, whereby at least one of a size and the shape of the implantable device is altered by increasing and decreasing the length of the flexible member extending within the opening of the hollow member; and

an adjustment tool configured to be removeably coupled to the spindle for rotation thereof.

46. The apparatus of claim 45, wherein the implantable device comprises an adjustable annuloplasty ring.

47. The apparatus of claim 45, wherein the flexible member comprises a continuous flexible band.

48. An apparatus for controlling at least one of the shape and size of an anatomical structure or lumen, the apparatus comprising:

an implantable device adapted for attachment to an anatomical structure or lumen, the implantable device comprising a hollow tube having a flexible continuous inner member extending therethrough conforming to the shape of the implantable device, and a rotatable adjustment member comprising a spindle attached to the inner member and configured to receive an adjustment tool, wherein the inner member has a portion thereof wrapped about the spindle of varying extent by rotation of the spindle; and

said adjustment tool configured to provide adjustment of at least one of the shape and size of the implantable device by rotation of the spindle.

49. The apparatus of claim 48, wherein the inner member comprises a continuous flexible band.

50. The apparatus of claim 48, wherein rotation of the spindle in a first direction causes the member to be taken up by the spindle thereby shortening the member, and wherein rotation of the spindle in a second direction causes the member to be let out thereby lengthening the member.

51. An apparatus for controlling at least one of a shape or size of an anatomical structure or lumen, the apparatus comprising:

an adjustable ring shaped implantable device having at least one of an adjustable shape or size, the implantable device including an elongated hollow member defining an elongated opening extending therethrough;

an elongated flexible member extending through the elongated opening of the hollow member conforming to the shape of the implantable device; and

a rotatable spindle in communication with the elongated opening, wherein a portion of the flexible member is coupled to the spindle;

an adjustment tool configured to be releasably attachable to the spindle for effecting rotation of the spindle; and

wherein rotation of the spindle in a first direction causes the flexible member to wrap around the spindle thereby shortening the length of the flexible member extending through the hollow member, and rotation of the spindle in a second direction opposite to the first direction cause the flexible member to unwrap from about the spindle thereby lengthening the length of the flexible member extending through the hollow member, whereby at least one of the shape or size of the implantable device is altered in response to the rotation of the spindle.

52. The apparatus of claim 51, wherein the implantable device comprises an annuloplasty ring.

53. The apparatus of claim 51, wherein the flexible member comprises a continuous band.

54. An apparatus of claim 51, wherein the hollow member comprises a tubular member.

55. An apparatus for controlling at least one of the shape or size of an anatomical structure or lumen, the apparatus comprising:

an adjustment tool;

an annuloplasty ring adapted for attachment to an anatomical structure or lumen, the annuloplasty ring comprising an elongated hollow tube providing an elongated opening and having an elongated flexible inner member extending therethrough conforming to the shape of the annuloplasty ring, and a rotatable adjustment member in communication with the opening attached to the inner member and configured to releasably receive the adjustment tool; and

wherein the adjustment tool is configured to provide adjustment of at least one of the shape or size of the annuloplasty ring by rotation of the adjustment member.

56. The apparatus of claim 55, wherein the adjustment member comprises a winch having a rotatable spindle coupled to the inner member.

57. The apparatus of claim 56, wherein a portion of the inner member is wrapped about the spindle.

58. An apparatus for controlling at least one of the shape or size of an anatomical structure or lumen, comprising:

an implantable annuloplasty ring having at least one of an adjustable shape or size, the ring comprising an elongated hollow member providing an elongated opening, a rotatable spindle arranged in communication with the opening, an elongated flexible member extending through the opening, the flexible member having a portion coupled to the spindle, the flexible member conforming to the shape of the ring when adjusted by an adjustment tool adapted to be releasably coupled to the spindle, wherein the spindle includes a first opening receiving a portion of the flexible member; and

wherein rotation of the spindle in a first direction causes the flexible member to wrap around the spindle thereby shortening the length of the flexible member extending through the hollow member, and rotation of the spindle in a second direction opposite to the first direction cause the flexible member to unwrap from about the spindle thereby lengthening the length of the flexible member extending through the hollow member, whereby at least one of the shape or size of the implantable ring is altered in response to the rotation of the spindle.

59. The apparatus of claim 58, wherein the spindle includes a second opening receiving another portion of the flexible member.

60. The apparatus of claim 58, further including an adjustment tool.

61. An apparatus for controlling at least one of a shape and size of an anatomical structure or lumen, the apparatus comprising:

an implantable annuloplasty ring including a hollow member forming an elongated opening therethrough, an elongated flexible member extending through the opening and a spindle, a portion of the flexible member coupled to the spindle, wherein the spindle includes a first opening receiving a portion of the flexible member wherein the spindle is configured so that rotation of the spindle in a first direction causes the flexible member to wrap around the spindle and rotation of the spindle in a second direction causes the flexible member to unwrap from the spindle thereby changing at least one of a shape and size of the annuloplasty ring; and

one or more fastening devices configured to provide fastening of the annuloplasty ring to the anatomical structure or lumen, wherein the one or more fastening devices are arranged at different locations on the annuloplasty ring.