Method and apparatus for valve repair

• US 7,125,421 B2
• Filed: 08/30/2002
• Issued: 10/24/2006
• Est. Priority Date: 08/31/2001
• Status: Expired due to Term

• Current Assignee: Mitral Interventions Incorporated
• Original Assignee: Mitral Interventions Incorporated
• Inventors: Tremulis, William S., Razavi, Mahmood K.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Matthews, William H
• Application Number:
  US10/232,753
• Publication Number:
  US 20030069593A1
• Time in Patent Office: 1,516 Days
• Field of Search: 623/2.1, 623/2.37, 623/2.36
• US Class Current: 623/2.37
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

A tissue connection device is provided for use on a patient at a treatment site. The device comprises an elongate member having a distal end and a proximal end. The elongate member has a first, substantially linear configuration during delivery through an elongate delivery device, wherein the first configuration is sufficient to allow said member to be delivered percutaneously into the patient to the treatment site. The elongate member has a second, substantially circular configuration when said member disengages from the delivery device, wherein the second configuration is sufficient to support tissue at the treatment site. The elongate member in the second configuration defines a single ring.

Claims

1. A tissue connecting device for use with an elongate delivery device on tissue at a target site, the device comprising:

an elongate member deliverable to the target site via the elongate delivery device, said elongate member assuming a first substantially linear configuration while engaged with said delivery device and a second substantially circular configuration defining a first support ring and a second support ring when removed from the delivery device;

wherein the elongate member has a first support ring radial thickness different from a second support ring radial thickness, said first support ring configured to abut against one side of the target tissue and said second support ring configured to abut against an opposite side of the target tissue to thereby capture a portion of the target tissue therebetween;

at least one suture coupled to the elongate member; and

wherein said first support ring is coupled to said second ring via a wire extending radially towards the center of the two rings in a manner sufficient to pass through a non-tissue center of the targeted valve.

2. A tissue connecting device for use with an elongate delivery device on tissue at a target site, the device comprising:

an elongate member deliverable to the target site via the elongate delivery device, said elongate member assuming a first substantially linear configuration while engaged with said delivery device and a second substantially circular configuration defining a first support ring and a second support ring when removed from the delivery device;

wherein the elongate member has a first support ring radial thickness different from a second support ring radial thickness, said first support ring configured to abut against one side of the target tissue and said second support ring configured to abut against an opposite side of the target tissue to thereby capture a portion of the target tissue therebetween;

at least one suture coupled to the elongate member; and

wherein said delivery device comprises a catheter.

3. A tissue connecting device for use with an elongate delivery device on tissue at a target site, the device comprising:

an elongate member deliverable to the target site via the elongate delivery device, said elongate member assuming a first substantially linear configuration while engaged with said delivery device and a second substantially circular configuration defining a first support ring and a second support ring when removed from the delivery device;

wherein the elongate member has a first support ring radial thickness different from a second support ring radial thickness, said first support ring configured to abut against one side of the target tissue and said second support ring configured to abut against an opposite side of the target tissue to thereby capture a portion of the target tissue therebetween at least one detachable suture removably coupled to the elongate member and wherein said first support ring is coupled to said second ring via a wire extending radially towards the center of the two rings in a manner sufficient to pass through a non-tissue center of the targeted valve.

4. A tissue connection device for use with an elongate delivery device and at least one suture on tissue at a treatment site in a patient, the device comprising:

an elongate member deliverable to a target tissue site via the elongate delivery device, said elongate member assuming a first substantially linear configuration while engaged with the elongate delivery device and a second relaxed configuration defining a first support ring and a second support ring when removed from the elongate delivery device;

said elongate member in said circular configuration shaped to have a distance between a first ring tissue engaging surface and a second ring tissue engaging surface;

at least one suture coupled to said elongate member for seating said member against the treatment site; and

wherein said suture reduces said distance therebetween and increases clamp force on any tissue between said first ring tissue engaging surface and the second ring tissue engaging surface.

5. The device of claim 4 wherein the elongate member is deliverable percutaneously.

6. The device of claim 4 wherein the elongate member has a reduced stiffness wherein said first ring and said second ring reduce valve dilation of tissue therebetween only with use of said suture.

7. The device of claim 4 wherein the elongate member is deliverable to engage a heart valve.

8. The device of claim 4 wherein the first support ring radial thickness greater than said second ring radial thickness.

9. The device of claim 4 wherein at least an outer portion of the first support ring comprises a material selected from one of the following:

a nickel titanium alloy, superelastic metallic alloys, superelastic plastic, PTFE, silicone, stainless steel, and ceramic.

10. The device of claim 4 wherein said elongate member comprises a shape-memory material.

11. The device of claim 4 wherein said elongate member comprises a material allowing for penetration by a suture needle to attach a suture therein.

12. The device of claim 4 wherein said elongate member has an outer layer comprising a material allowing for penetration by a suture needle to attach a suture therein.

13. The device of claim 4 further comprising a plurality of apertures on said first ring sufficient for attachment of sutures to the first ring.

14. The device of claim 4 wherein first support ring has a surface suitable for engagement by sutures.

15. The device of claim 4 wherein said elongate member comprises a material suitable for penetration by sutures.

16. The device of claim 4 wherein first support ring has a mesh cover.

17. The device of claim 4 wherein the first support ring has a Dacron®

covering.

18. The device of claim 4 further comprising a plurality of anchoring locations on said first support ring sufficient to allow for attachment of sutures to the first ring.

19. The device of claim 4 further comprising at least one suture coupled to the elongate member.

20. The device of claim 4 further comprising at least one detachable suture removably coupled to the elongate member.

21. The device of claim 4 wherein said elongate member includes at least one radiopaque marker.

22. The device of claim 4 wherein said distal end is spaced apart from said proximal end when said elongate member is in the first, substantially linear configuration.

23. The device of claim 4 wherein said first support ring and said second support ring define an overlapping coil configuration.

24. The device of claim 23 wherein said first support ring is configured to engage an inner circumferential surface of the second support ring.

25. The device of claim 4 wherein said first support ring is in a plane parallel to a second support ring plane.

26. The device of claim 4 wherein said elongate member is configured to connect the first ring to the second ring without penetrating said target tissue.

27. The device of claim 4 wherein said delivery device comprises a catheter.

28. A tissue connection device for use with an elongate delivery device and at least one suture on tissue at a treatment site in a patient, the device comprising:

an elongate member deliverable to a target tissue site via the elongate delivery device, said elongate member assuming a first substantially linear configuration while engaged with the elongate delivery device and a second relaxed configuration defining a first support ring and a second support ring when removed from the elongate delivery device;

said elongate member in said circular configuration shaped to have a distance between a first ring tissue engaging surface and a second ring tissue engaging surface;

at least one suture coupled to said elongate member for seating said member against the treatment site; and

wherein the elongate member has a reduced stiffness wherein said first ring and said second ring reduce valve dilation of tissue therebetween only with use of said suture.

29. The device of claim 28 wherein said suture reduces said distance therebetween and increases clamp force on any tissue between said first ring tissue engaging surface and the second ring tissue engaging surface.

30. The device of claim 28 wherein the elongate member is deliverable percutaneously.

31. The device of claim 28 wherein the elongate member is deliverable to engage a heart valve.

32. The device of claim 28 wherein the first support ring radial thickness greater than said second ring radial thickness.

33. The device of claim 28 wherein at least an outer portion of the first support ring comprises a material selected from one of the following:

a nickel titanium alloy, superelastic metallic alloys, superelastic plastic;

PTFE, silicone, stainless steel, and ceramic.

34. The device of claim 28 wherein said elongate member comprises a shape-memory material.

35. The device of claim 28 wherein said elongate member comprises a material allowing for penetration by a suture needle to attach a suture therein.

36. The device of claim 28 wherein said elongate member has an outer layer comprising a material allowing for penetration by a suture needle to attach a suture therein.

37. The device of claim 28 further comprising a plurality of apertures on said first ring sufficient for attachment of sutures to the first ring.

38. The device of claim 28 wherein first support ring has a surface suitable for engagement by sutures.

39. The device of claim 28 wherein said elongate member comprises a material suitable for penetration by sutures.

40. The device of claim 28 wherein first support ring has a mesh cover.

41. The device of claim 28 wherein the first support ring has a Dacron®

covering.

42. The device of claim 28 further comprising a plurality of anchoring locations on said first support ring sufficient to allow for attachment of sutures to the first ring.

43. The device of claim 28 further comprising at least one suture coupled to the elongate member.

44. The device of claim 28 further comprising at least one detachable suture removably coupled to the elongate member.

45. The device of claim 28 wherein said elongate member includes at least one radiopaque marker.

46. The device of claim 28 wherein said distal end is spaced apart from said proximal end when said elongate member is in the first, substantially linear configuration.

47. The device of claim 28 wherein said first support ring and said second support ring define an overlapping coil configuration.

48. The device of claim 47 wherein said first support ring is configured to engage an inner circumferential surface of the second support ring.

49. The device of claim 28 wherein said first support ring is in a plane parallel to a second support ring plane.

50. The device of claim 28 wherein said elongate member is configured to connect the first ring to the second ring without penetrating said target tissue.

51. The device of claim 28 wherein said delivery device comprises a catheter.

52. A tissue connection device for use with an elongate delivery device and at least one suture on tissue at a treatment site in a patient, the device comprising:

an elongate member deliverable to a target tissue site via the elongate delivery device, said elongate member assuming a first substantially linear configuration while engaged with the elongate delivery device and a second relaxed configuration defining a first support ring and a second support ring when removed from the elongate delivery device;

said elongate member in said circular configuration shaped to have a distance between a first ring tissue engaging surface and a second ring tissue engaging surface;

at least one suture coupled to said elongate member for seating said member against the treatment site; and

a plurality of apertures on said first ring sufficient for attachment of sutures to the first support ring.

53. The device of claim 52 wherein said suture reduces said distance therebetween and increases clamp force on any tissue between said first ring tissue engaging surface and the second ring tissue engaging surface.

54. The device of claim 52 wherein the elongate member is deliverable percutaneously.

55. The device of claim 52 wherein the elongate member has a reduced stiffness wherein said first ring and said second ring reduce valve dilation of tissue therebetween only with use of said suture.

56. The device of claim 52 wherein the elongate member is deliverable to engage a heart valve.

57. The device of claim 52 wherein the first support ring radial thickness greater than said second ring radial thickness.

58. The device of claim 52 wherein at least an outer portion of the first support ring comprises a material selected from one of the following:

a nickel titanium alloy, superelastic metallic alloys, superelastic plastic, PTFE, silicone, stainless steel, and ceramic.

59. The device of claim 52 wherein said elongate member comprises a shape-memory material.

60. The device of claim 52 wherein said elongate member comprises a material allowing for penetration by a suture needle to attach a suture therein.

61. The device of claim 52 wherein said elongate member has an outer layer comprising a material allowing for penetration by a suture needle to attach a suture therein.

62. The device of claim 52 wherein first support ring has a surface suitable for engagement by sutures.

63. The device of claim 52 wherein said elongate member comprises a material suitable for penetration by sutures.

64. The device of claim 52 wherein first support ring has a mesh cover.

65. The device of claim 52 wherein the first support ring has a Dacron®

covering.

66. The device of claim 52 further comprising a plurality of anchoring locations on said first support ring sufficient to allow for attachment of sutures to the first ring.

67. The device of claim 52 further comprising at least one suture coupled to the elongate member.

68. The device of claim 52 further comprising at least one detachable suture removably coupled to the elongate member.

69. The device of claim 52 wherein said elongate member includes at least one radiopaque marker.

70. The device of claim 52 wherein said distal end is spaced apart from said proximal end when said elongate member is in the first, substantially linear configuration.

71. The device of claim 52 wherein said first support ring and said second support ring define an overlapping coil configuration.

72. The device of claim 71 wherein said first support ring is configured to engage an inner circumferential surface of the second support ring.

73. The device of claim 52 wherein said first support ring is in a plane parallel to a second support ring plane.

74. The device of claim 52 wherein said elongate member is configured to connect the first ring to the second ring without penetrating said target tissue.

75. The device of claim 52 wherein said first support ring is coupled to said second ring via a wire extending radially towards the center of the two rings in a manner sufficient to pass through a non-tissue center of the targeted valve.

76. The device of claim 52 wherein said elongate member is configured to connect the first ring to the second ring without penetrating said target tissue.

77. The device of claim 52 wherein said delivery device comprises a catheter.

78. A tissue connection device for use with an elongate delivery device and at least one suture on tissue at a treatment site in a patient, the device comprising:

an elongate member deliverable to a target tissue site via the elongate delivery device, said elongate member assuming a first substantially linear configuration while engaged with the elongate delivery device and a second relaxed configuration defining a first support ring and a second support ring when removed from the elongate delivery device;

said elongate member in said circular configuration shaped to have a distance between a first ring tissue engaging surface and a second ring tissue engaging surface;

at least one suture coupled to said elongate member for seating said member against the treatment site;

at least one detachable suture removably coupled to the elongate member; and

a plurality of apertures on said first ring sufficient for attachment of sutures to the first ring.

79. A tissue connection device for use with an elongate delivery device and at least one suture on tissue at a treatment site in a patient, the device comprising:

an elongate member deliverable to a target tissue site via the elongate delivery device, said elongate member assuming first substantially linear configuration while engaged with the elongate delivery device and a second relaxed configuration defining a first support ring and a second support ring when removed from the elongate delivery device;

said elongate member in said circular configuration shaped to have a distance between a first ring tissue engaging surface and a second ring tissue engaging surface;

at least one suture coupled to said elongate member for seating said member against the treatment site;

at least one detachable suture removably coupled to the elongate member; and

wherein said first support ring is coupled to said second ring via a wire extending radially towards the center of the two rings in a manner sufficient to pass through a non-tissue center of the targeted valve.