Percutaneous mitral annuloplasty and cardiac reinforcement

• US 6,537,314 B2
• Filed: 01/30/2001
• Issued: 03/25/2003
• Est. Priority Date: 01/31/2000
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: EV3 Santa Rosa, Inc.
• Inventors: Lesh, Michael D., Langberg, Jonathan J., van der Burg, Erik
• Primary Examiner(s): Isabella, David J.
• Assistant Examiner(s): Chattopadhyay, Urmi
• Application Number:
  US09/774,869
• Publication Number:
  US 20020103533A1
• Time in Patent Office: 784 Days
• Field of Search: 623/1-1-, 623/1.35, 623/1.1, 623/2--, 604/509, 604/510, 604/96.01, 604/523, 604/528, 604/544, 604/920
• US Class Current: 623/2.36
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A mitral annuloplasty and left ventricle restriction device is designed to be transvenously advanced and deployed within the coronary sinus and in some embodiments other coronary veins. The device places tension on adjacent structures, reducing the diameter and/or limiting expansion of the mitral annulus and/or limiting diastolic expansion of the left ventricle. These effects may be beneficial for patients with dilated cardiomyopathy.

Claims

1. An implant for positioning within a vessel to influence tissue outside of the vessel, comprising:

an elongate, flexible body, having a proximal end and a distal end, each of the proximal and distal ends dimensioned to reside completely within the vascular system; and

a forming element attached within the body, the forming element comprising a polymeric strand;

wherein rotation of at least a portion of the forming element with respect to the body changes the shape of the body from an implantation configuration to a remodeling configuration, wherein at least a portion of the forming element remains attached to the body following implantation.

2. An implant as in claim 1, wherein the body is reversibly movable between an implantation configuration for transluminal implantation and a remodeling configuration for exerting a force against a vessel wall.

3. An implant as in claim 2, wherein the body defines an arc when in the remodeling configuration.

4. An implant as in claim 3, wherein a best fit constant radius curve corresponding to the arc has a radius within the range of from about 10 mm to about 20 mm.

5. An implant as in claim 1, further comprising a lock for retaining the body in the remodeling configuration.

6. An implant as in claim 5, wherein the lock comprises a locking ring.

7. An implant as in claim 5, wherein the lock comprises an interference fit.

8. An implant as in claim 5, wherein the lock comprises an adhesive bond.

9. An implant as in claim 5, wherein the lock comprises a suture knot.

10. An implant as in claim 5, wherein the lock comprises a clamp.

11. An implant as in claim 5, wherein the lock comprises a compression fit.

12. An implant as in claim 5, wherein the lock comprises a ratchet.

13. An implant as in claim 5, wherein the lock comprises an engagement surface, which is movable between a first, disengaged configuration and a second, engaged configuration.

14. An implant as in claim 5, wherein the lock is biased in a locked direction.

15. An implant as in claim 5, wherein the lock is biased in an unlocked direction.

16. An implant as in claim 5, further comprising a coating on the body.

17. An implant as in claim 1, further comprising an anchor for retaining the implant at a deployment site within a vessel.

18. An implant as in claim 17, wherein the anchor comprises a distal extension of the implant.

19. An implant as in claim 17, wherein the anchor comprises a friction enhancing surface structure for engaging the wall of the vessel.

20. An implant as in claim 17, wherein the anchor comprises at least one barb for piercing the wall of the vessel.

21. An implant as in claim 1, wherein the body has an axial length of no more than about 10 cm.

22. An implant as in claim 1, wherein the maximum cross sectional dimension through the implant is no more than about 10 mm.

23. An implant as in claim 1, further comprising an axially extending support in the body, attached to the forming element.

24. An implant as in claim 1, wherein the forming element comprises a metal wire.

25. An implant as in claim 1, wherein the forming element comprises a multifilament structure.

26. An implant as in claim 1, wherein the forming element comprises a screw thread.

27. An implant for positioning within a vessel to influence tissue outside of the vessel, comprising:

an elongate, flexible body, having a proximal end and a distal end, each of the proximal and distal ends dimensioned to reside completely within the vascular system; and

a forming element attached within the body, the forming element comprising a screw, at least partially within the flexible body;

wherein rotation of at least a portion of the forming element with respect to the body changes the shape of the body from an implantation configuration to a remodeling configuration, wherein at least a portion of the forming element remains attached to the body following implantation.

28. An implant as in claim 27, wherein the body is reversibly movable between an implantation configuration for transluminal implantation and a remodeling configuration for exerting a force against a vessel wall.

29. An implant as in claim 28, wherein the body defines an arc when in the remodeling configuration.

30. An implant as in claim 29, wherein a best fit constant radius curve corresponding to the arc has a radius within the range of from about 10 mm to about 20 mm.

31. An implant as in claim 27, further comprising a lock for retaining the body in the remodeling configuration.

32. An implant as in claim 31, wherein the lock comprises a locking ring.

33. An implant as in claim 31, wherein the lock comprises an interference fit.

34. An implant as in claim 31, wherein the lock comprises an adhesive bond.

35. An implant as in claim 31, wherein the lock comprises a suture knot.

36. An implant as in claim 31, wherein the lock comprises a clamp.

37. An implant as in claim 31, wherein the lock comprises a compression fit.

38. An implant as in claim 31, wherein the lock comprises a ratchet.

39. An implant as in claim 31, wherein the lock comprises an engagement surface, which is movable between a first, disengaged configuration and a second, engaged configuration.

40. An implant as in claim 31, wherein the lock is biased in a locked direction.

41. An implant as in claim 31, wherein the lock is biased in an unlocked direction.

42. An implant as in claim 31, further comprising a coating on the body.

43. An implant as in claim 27, further comprising an anchor for retaining the implant at a deployment site within a vessel.

44. An implant as in claim 43, wherein the anchor comprises a distal extension of the implant.

45. An implant as in claim 43, wherein the anchor comprises a friction enhancing surface structure for engaging the wall of the vessel.

46. An implant as in claim 43, wherein the anchor comprises at least one barb for piercing the wall of the vessel.

47. An implant as in claim 27, wherein the body has an axial length of no more than about 10 cm.

48. An implant as in claim 27, wherein the maximum cross sectional dimension through the implant is no more than about 10 mm.

49. An implant as in claim 27, further comprising an axially extending support in the body, attached to the forming element.

50. An implant as in claim 27, wherein the forming element comprises a polymeric strand.

51. An implant as in claim 27, wherein the forming element comprises a multifilament structure.

52. An implant for positioning within a vessel to influence tissue outside of the vessel, comprising:

an elongate, flexible body, having a proximal end and a distal end, each of the proximal and distal ends dimensioned to reside completely within the vascular system; and

a forming element attached within the body, the forming element comprising a multifilament structure;

wherein rotation of at least a portion of the forming element with respect to the body changes the shape of the body from an implantation configuration to a remodeling configuration, wherein at least a portion of the forming element remains attached to the body following implantation.

53. An implant as in claim 52, wherein the body is reversibly movable between an implantation configuration for transluminal implantation and a remodeling configuration for exerting a force against a vessel wall.

54. An implant as in claim 53, wherein the body defines an arc when in the remodeling configuration.

55. An implant as in claim 54, wherein a best fit constant radius curve corresponding to the arc has a radius within the range of from about 10 mm to about 20 mm.

56. An implant as in claim 52, further comprising a lock for retaining the body in the remodeling configuration.

57. An implant as in claim 56, wherein the lock comprises a locking ring.

58. An implant as in claim 56, wherein the lock comprises an interference fit.

59. An implant as in claim 56, wherein the lock comprises an adhesive bond.

60. An implant as in claim 56, wherein the lock comprises a suture knot.

61. An implant as in claim 56, wherein the lock comprises a clamp.

62. An implant as in claim 56, wherein the lock comprises a compression fit.

63. An implant as in claim 56, wherein the lock comprises a ratchet.

64. An implant as in claim 56, wherein the lock comprises an engagement surface, which is movable between a first, disengaged configuration and a second, engaged configuration.

65. An implant as in claim 56, wherein the lock is biased in a locked direction.

66. An implant as in claim 56, wherein the lock is biased in an unlocked direction.

67. An implant as in claim 56, further comprising a coating on the body.

68. An implant as in claim 52, further comprising an anchor for retaining the implant at a deployment site within a vessel.

69. An implant as in claim 68, wherein the anchor comprises a distal extension of the implant.

70. An implant as in claim 68, wherein the anchor comprises a friction enhancing surface structure for engaging the wall of the vessel.

71. An implant as in claim 68, wherein the anchor comprises at least one barb for piercing the wall of the vessel.

72. An implant as in claim 52, wherein the body has an axial length of no more than about 10 cm.

73. An implant as in claim 52, wherein the maximum cross sectional dimension through the implant is no more than about 10 mm.

74. An implant as in claim 52, further comprising an axially extending support in the body, attached to the forming element.

75. An implant as in claim 52, wherein the forming element comprises a polymeric strand.

76. An implant as in claim 52, wherein the forming element comprises a metal wire.

77. An implant as in claim 52, wherein the forming element comprises a screw thread.