Annuloplasty devices and related heart valve repair methods

• US 20020173841A1
• Filed: 05/14/2002
• Published: 11/21/2002
• Est. Priority Date: 07/06/2000
• Status: Active Grant

• Current Assignee: Medtentia International Ltd. Oy
• Original Assignee: Paul A. Spence
• Inventors: Ortiz, Mark, Spence, Paul A., Whedon, Randy
• Granted Patent: US 6,730,121 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0033 electrically, e.g. heated by resistor
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/006 modular

Abstract

Devices for repairing and replacing a heart valve in various embodiments, the devices include at least first and second support rings connected together in a coiled configuration to abut opposite sides of a valve annulus. A replacement valve may be secured to the coil-shaped device. Various alternative fastening systems include suture fastening systems, mechanical fastening systems, shape memory alloy fastening systems and other fastening systems relying only on the resilience between adjacent coils. A method generally includes inserting a first end of the coil-shaped member through a valve annulus, rotating a first ring of the coil-shaped member into position on one side of the valve annulus and positioning at least a second ring of the coil-shaped member on an opposite side of the valve annulus.

Claims

1. A device for repairing a heart valve comprised of valve tissue including an annulus and a plurality of leaflets for allowing and preventing blood flow, the device comprising:

a first support ring, and

a second support ring connected to said first support ring to form a coiled configuration, said first support ring configured to abut one side of the valve and said second support ring configured to abut an opposite side of the valve to thereby trap a portion of the valve tissue therebetween.

2. The device of claim 1, wherein said first and second support rings each have an inner core covered by an outer layer, said inner core formed from a more rigid material than said outer layer.

3. The device of claim 1, wherein said first and second support rings have generally triangular-shaped cross sections.

4. The device of claim 1, further comprising:

a plurality of fasteners extending between said first and second support rings.

5. The device of claim 4, wherein said fasteners comprise sharp projections.

6. The device of claim 4, wherein said fasteners comprises projections extending from said first support ring and receiving members on said second support ring configured to engage with said projections.

7. The device of claim 1, further comprising an actuating member coupled to at least one of said support rings and operating to actuate the fasteners to an extended position through the valve tissue.

8. The device of claim 1, wherein said first and second support rings are formed from a shape memory alloy.

9. The device of claim 1, further comprising a removable material on at least one of said first and second support rings for reducing friction between the respective rings and the valve tissue during initial engagement therewith, said material being removable to increase the friction during securement of the device to the valve tissue.

10. The device of claim 1, wherein opposed surfaces of said first and second support rings are roughened to facilitate engagement with the valve tissue.

11. The device of claim 10, further comprising a coating of cushioning material on each of said opposed surfaces.

12. The device of claim 1, wherein each of said support rings is formed from a fabric material.

13. The device of claim 1, wherein at least one of said support rings includes undulations.

14. The device of claim 1, wherein said support rings are formed from a flat plate material.

15. The device of claim 1, wherein said first and second support rings are formed integrally from a coiled rod with one end of said rod formed a leading end on said first support ring and another end of said rod forming a trailing end on said second support ring.

16. The device of claim 15, wherein said leading and trailing ends are bent in generally opposite directions.

17. The device of claim 1, wherein said first and second support rings have a multi-layered construction including an inner layer of a first material and an outer layer of a second material, said inner layer having a lower coefficient of friction than said outer layer, and said inner layer being exposed on opposed surfaces of said first and second support rings which are adapted to engage the valve tissue there between.

18. The device of claim 1, further comprising a removable carrier configured to carry said first and second support rings into position on opposite sides of the valve and then be removed leaving said first and second support rings on opposite sides of the valve.

19. The device of claim 1, wherein said first and second support rings are adjustable in diameter to allow adjustment of the valve annulus.

20. A device for repairing a heart valve comprised of valve tissue including an annulus and a plurality of leaflets for allowing and preventing blood flow, the device comprising:

a valve support device configured for attachment to at least one side of the heart valve, and

a coil-shaped carrier removably coupled with said valve support device for allowing said valve support device to be turned into position on said at least one side and secured to a portion of the valve tissue to support the heart valve.

21. A device for repairing a heart valve comprised of valve tissue including an annulus and a plurality of leaflets for allowing and preventing blood flow, the device comprising:

a catheter having a lumen and an open end,

an elongate valve support member carried within said lumen and movable from said open end, said elongate valve support member having an uncoiled configuration within said lumen and assuming a coiled configuration when extended from said open end.

22. The device of claim 21, wherein said elongate valve support member including an inner core covered by an outer layer, said inner core formed from a more rigid material than said outer layer.

23. The device of claim 21, wherein said elongate valve support member has a generally triangular-shaped cross section.

25. The device of claim 24, wherein said actuator further comprises a gripping element operable to grip and allow releasing of one end of said elongate valve support member.

26. The device of claim 21, wherein said elongate valve support member is formed from a shape memory alloy.

28. The device of claim 27, wherein said first and second support members are ring shaped.

29. The device of claim 27 further comprising:

a plurality of fastening elements on at least one of said first and second support members for engaging the valve tissue when the shape memory alloy is in the activated shape.

30. The device of claim 29, wherein said first support member includes at least one projection and said second support member includes at least one fastening portion to receive said projection.

24. The device of 21 further comprising:

an actuator carried within said lumen and operable to extend said elongate valve support member from said open end.

27. A device for repairing a heart valve comprised of valve tissue including an annulus and a plurality of leaflets for allowing and preventing blood flow, the device comprising:

a first support member at least partially formed from a shape memory alloy operable to assume an activated shape and an inactivated shape, and

a second support member at least partially formed from said shape memory alloy and connected to said first support member, said first support member configured to abut one side of the valve and said second support member configured to abut an opposite side of the valve, whereby a portion of the valve tissue is trapped between said first and second support members upon said shape memory alloy assuming said activated shape.

31. A device for repairing a heart valve comprised of valve tissue including an annulus and a plurality of leaflets for allowing and preventing blood flow, the device comprising:

a carrier, and

a coil-shaped member connected to said carrier in a removable manner, said coil-shaped member having a first support ring configured to abut one side of the valve and a second support ring configured to abut an opposite side of the valve to thereby trap a portion of the valve tissue therebetween.

32. The device of claim 31 further comprising:

a plurality of fasteners extending between said first and second support rings.

33. The device of claim 32, wherein said fasteners comprise sharp projections.

35. The device of claim 34, wherein said replacement valve is coupled to said second support ring in a removable manner.

36. The device of claim 35, wherein said replacement valve and said second support ring include mating engagement elements to allow coupling in the relatable manner.

37. The device of claim 35, wherein said replacement valve is threadable into said second support ring.

38. The device of claim 34, wherein said first and second support rings are contained in generally the same plane.

39. The device of claim 34, wherein said first and second support rings are contained in substantially different planes.

40. The device of claim 34, wherein said replacement valve and said second support ring include respective cuffs adapted to receive sutures applied therebetween to fasten said replacement valve to said second support ring.

41. The device of claim 34, wherein said second support ring includes a cuff containing a movable fastening element which is engageable with said replacement valve to couple said replacement valve to said second support ring.

42. The device of claim 41, wherein said fastening element is formed from a shape memory alloy.

34. A replacement valve device for replacing a heart valve of a patient, the device comprising:

a first support ring, and

a second support ring connected to said first support ring to form a coiled configuration, said first support ring configured to abut one side of an area of valve tissue and said second support ring configured to abut an opposite side of the area of the valve tissue to thereby trap the valve tissue therebetween, and

a replacement valve coupled to said second support ring and including at least one valve element extending within said second support ring for allowing and preventing blood flow therethrough.

43. A method of repairing a heart valve comprised of valve tissue including an annulus and a plurality of leaflets for allowing and preventing blood flow, the method comprising:

inserting a first end of a coil-shaped support through a portion of the valve tissue,

rotating at least a first ring of the coil-shaped support to position the first ring on a first side of the valve, and

positioning at least a second ring of the coil-shaped support on an opposite second side of the valve.

44. The method of claim 43, further comprising:

fastening the first and second rings together to trap the valve tissue therebetween.

45. The method of claim 44, wherein the step of fastening the first and second rings together further comprises:

inserting fasteners through said first and second rings and through the valve tissue disposed therebetween.

46. The method of claim 44, wherein the step of fastening the first and second rings together further comprises:

activating a plurality of sharp projections from said first ring toward said second ring and through the valve tissue disposed therebetween.

47. The method of claim 43, wherein the inserting and rotating steps each further comprise:

extending the coil shaped support from a catheter.

48. The method of claim 43, wherein said coil shaped support is coupled with a carrier during the inserting, rotating and positioning steps, and the method further comprises:

removing the carrier after the positioning step.

49. The method of claim 48, further comprising:

driving a plurality of fastening elements through the coil shaped support and valve tissue, and against the carrier prior to removing the carrier.

50. The method of claim 43, wherein said coil shaped support includes a material having a lower coefficient of friction than said outer surface, and the method further comprising:

performing at least the inserting and rotating steps with the material disposed on at least a portion of the outer surface, and

removing the material after the rotating step.

51. The method of claim 50 further comprising:

removing the material after the positioning step.

52. The method of claim 43, further comprising:

adjusting the diameter of at least one of said first and second rings to adjust the diameter of the annulus.

53. The method of claim 43, further comprising:

coupling a replacement valve to at least one of said first and second rings.

54. A method of replacing a heart valve of a patient, the method comprising:

inserting a first end of a coil-shaped support through an area of valve tissue,

rotating at least a first ring of the coil-shaped support to position the first ring on a first side of the valve tissue,

positioning at least a second ring of the coil-shaped support on an opposite second side of the valve tissue, and

coupling a replacement valve to at least one of the first and second rings.

55. The method of claim 54, wherein the valve tissue is an annulus associated with a native heart valve.

56. The method of claim 54, wherein coupling the replacement valve further comprises suturing a cuff on the replacement valve to a cuff on one of the first and second rings.

57. The method of claim 54, wherein coupling the replacement valve further comprises rotating the replacement valve into sealing engagement with one of the first and second rings.

58. The method of claim 54, wherein coupling the replacement valve further comprises rotating a cuff on the replacement valve over one of the first and second rings.

59. The method of claim 54, wherein coupling the replacement valve further comprises activating a fastening element formed from a shape memory alloy.