FLEXIBLE HEART VALVE

• US 20020055775A1
• Filed: 06/14/1999
• Published: 05/09/2002
• Est. Priority Date: 01/26/1999
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: CARPENTIER, ALAIN F., RHEE, RICHARD S., SCHRECK, STEFAN G., NGUYEN-THIEN-NHON, DIANA, LAM, HUNG LY, RECKTENWALD, WILLIAM
• Granted Patent: US 6,558,418 B2
• Time in Patent Office: Days
• US Class Current: 623/2.17
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body

Abstract

A highly flexible tissue-type heart valve is disclosed having a structural stent in a generally cylindrical configuration with cusps and commissures that are permitted to move radially. The stent commissures are constructed so that the cusps are pivotably or flexibly coupled together at the commissures to permit relative movement therebetween. The stent may be cloth-covered and may be a single element or may be made in three separate elements for a three cusp valve, each element having a cusp portion and two commissure portions; adjacent commissure portions for each pair of adjacent stent element combining to form the stent commissures. If the stent has separate elements their commissure portions may be pivotably or flexible coupled, or may be designed to completely separate into independent leaflets at bioresorbable couples. The cloth covering may have an outwardly projecting flap that mates with valve leaflets (e.g., pericardial leaflets) along the cusps and commissures. A connecting band may be provided that follows the cusps and commissures and extends outwardly. The valve is connected to the natural tissue along the undulating connecting band using conventional techniques, such as sutures. The connecting band may be a cloth-covered silicon member and attaches to the underside of the valve at the cusps to provide support to the stent and to the outer side of the valve at the commissures. A multi-legged holder is used to implant the valve, with the legs serving to maintain an implant shape to the valve. The holder may have six legs with one releasably connected to each cusp and one releasably connected to each commissure. A method of implantation of the flexible valve using the holder is also disclosed.

Claims

1. A prosthetic heart valve, comprising:

a flexible, generally cylindrical stent having alternating cusps and commissures;

a plurality of flexible leaflets attached to the stent so as to form a one-way valve within the cylinder; and

a flexible band attached along the stent and having a free edge extending outward from the stent along the alternating cusps and commissures for connecting the heart valve to an anatomical orifice.

3. The heart valve of either of claims 1 or 2, wherein the stent is configured to permit the cusps and commissures to move radially in and out.

4. The heart valve of either of claims 1 or 2, wherein the stent comprises a cloth-covered rod-like structure.

5. The heart valve of claim 4, wherein the cloth-covering closely surrounds the rod-like structure and exhibits a flap projecting outward therefrom substantially the entire length of the cusps and commissures for connecting to the band and leaflets.

6. The heart valve of either of claims 1 or 2, wherein the stent comprises a plurality of separate elements, each having arcuate cusp regions and upstanding commissure regions, wherein each pair of commissure regions of adjacent elements are juxtaposed to define each commissure.

7. The heart valve of claim 6, wherein each pair of commissure regions of adjacent elements is coupled together to be relatively fixed at the commissures, while the intermediate cusps are permitted to move radially with respect to the commissures.

8. The heart valve of either of claims 1 or 2, wherein the band comprises a suture-permeable inner member and a cloth outer cover, the band exhibiting continuous cusp portions and commissure portions.

9. The heart valve of claim 8, wherein the suture-permeable inner member comprises a molded silicone structure.

10. The heart valve of claim 8, wherein the band comprises an outwardly projecting series of parallel ribs extending continuously along the entire band cusp portions and commissure portions.

11. The heart valve of claim 8, wherein the commissure portions of the band are generally planar and axially aligned, and the cusp portions of the band each include an outwardly angled portion and an inwardly angled ledge.

12. The heart valve of claim 11, wherein the inwardly angled ledge of each cusp portion of the band extends inward a distance sufficient to support the corresponding cusp.

13. The heart valve of either of claims 1 or 2, wherein the band includes arcuate cusp portions generally conforming to the cusps, and the band includes commissure portions therebetween each having an inverted U-shape to define a downwardly opening gap that enhances flexibility of the valve by permitting relative cusp movement.

15. The heart valve of claim 14, wherein the stent comprises a plurality of separate members dispose generally in a circle to define the cylindrical volume, each member including an arcuate cusp portion and two upstanding commissure portions, wherein each pair of commissure portions of adjacent members is juxtaposed to define each stent commissure.

16. The heart valve of claim 14, wherein the cusps of the valve are hingedly connected to each other.

17. The heart valve of claim 16, wherein the stent comprises a single member and the cusps are hingedly connected to each other at coil springs.

18. The heart valve of claim 16, wherein the stent comprises a plurality of separate members dispose generally in a circle to define the cylindrical volume, each member including an arcuate cusp portion and two upstanding commissure portions, wherein each pair of commissure portions of adjacent members is juxtaposed to define each stent commissure.

19. The heart valve of claim 18, wherein each pair of commissure portions is connected with sutures to enable relative movement of adjacent cusp portions.

20. The heart valve of claim 18, wherein each commissure portion is connected to pivot about a first axis which is fixed with respect to a second axis about which the adjacent commissure portion pivots.

21. The heart valve of claim 20, wherein the first and second axes are coincident.

22. The heart valve of claim 21, wherein each commissure portion terminates at an arcuate tip, the valve further including coupling members having an arcuate channel therein, the coupling members receiving the arcuate tips of the commissure portions and permitting relative sliding movement about a pivot axis defined by the arcuate channel.

23. The heart valve of claim 20, wherein each commissure portion terminates at a generally circular tip, the valve further including coupling members having a pair of spaced pins provided thereon that defined the first and second axes and about which the circular tips of each commissure portion pivot.

24. The heart valve of claim 18, wherein the valve includes a plurality of pliable coupling members each of which couples to a pair of adjacent commissure portions to permit relative movement therebetween.

25. The heart valve of claim 24, wherein each commissure portion terminates at a generally linear tip, the pliable coupling members comprising pliable tubular sleeves closely fitting over the linear tips.

26. The heart valve of claim 14, further including means for connecting the stent cusps together at the stent commissures to enable relative movement of adjacent cusps.

27. The heart valve of claim 26, wherein the means for connecting the stent cusps together comprises sutures.

28. The heart valve of claim 26, wherein the means for connecting the stent cusps together comprises a flexible material interface.

29. The heart valve of claim 26, where the means for connecting the stent cusps together comprises a bioresorbable structure.

30. The heart valve of claim 14, wherein the stent comprises a cloth-covered rod-like structure.

31. The heart valve of claim 30, wherein the cloth-covering closely surrounds the rod-like structure and exhibits a flap projecting outward therefrom substantially the entire length of the cusps and commissures.

32. The heart valve of claim 31, wherein the flap has a width that varies along the cusps and commissures of the stent, the flap being narrower in the cusps.

33. The heart valve of claim 31, further including a flexible band attached along the stent flap and having a free edge extending outward from the stent along the alternating cusps and commissures for connecting the heart valve to an anatomical orifice.

34. The heart valve of claim 33, wherein the cusp edges of the leaflets are attached between the band and the stent flap.

35. The heart valve of claim 33, wherein the band exhibits continuous cusps and commissures, the cusps of the band each including an outwardly angled portion and an inwardly angled ledge extending inward a distance sufficient to support the corresponding cusp of the stent.

36. The heart valve of claim 30, wherein the rod-like structure is made of a polymer.

37. The heart valve of claim 22, wherein each separate member is separately cloth-covered.

38. The heart valve of claim 37, wherein each upstanding commissure portion terminates in a substantially circular bent tip, adjacent and bent tips of each separate member being juxtaposed and sutured together through the respective cloth coverings.

39. The heart valve of claim 18, wherein each leaflet includes an arcuate cusp edge terminating at outer tips joined to the stent commissures, and a coapting edge that is defined by two relatively angled lines joined at an apex midway between the two tips.

40. The heart valve of claim 39, wherein each leaflet is made of pericardial tissue.

41. The heart valve of claim 39, wherein the arcuate cusp edges gradually become asymptotic at the tips.

42. The heart valve of claim 39, further including an outwardly angled transition edge from the arcuate cusp edges to the tips.

43. The heart valve of claim 42, wherein a generally linear edge is defined between each outwardly angled transition edge and the corresponding tip defining a generally trapezoidal tab adjacent the tips.

44. The heart valve of claim 18, wherein each leaflet includes an arcuate cusp edge terminating at outer tips joined to the stent commissures, wherein adjacent tips are joined not to each other but to portions of the stent that are permitted to move with respect to one another.

45. The heart valve of claim 44, further including a flexible band attached along the stent and having a free edge extending outward from the stent along the alternating cusps and commissures for connecting the heart valve to an anatomical orifice, the band defining an inverted U-shape at the stent commissures with a gap formed between portions of the stent that are permitted to move with respect to one another.

47. The heart valve of claim 46, wherein each stent member includes an arcuate cusp region and two upstanding commissure regions, and wherein each pair of commissure regions of adjacent stent members is juxtaposed to define each stent commissure.

48. The heart valve of claim 47, further including means for connecting the stent members together at the stent commissures to enable relative movement of adjacent cusp regions.

49. The heart valve of claim 48, wherein the means for connecting the stent members together comprises sutures.

50. The heart valve of claim 48, wherein the means for connecting the stent members together comprises a flexible material interface.

51. The heart valve of claim 48, where the means for connecting the stent members together comprises a bioresorbable structure.

52. The heart valve of claim 47, wherein each commissure region is connected to pivot about a first axis which is fixed with respect to a second axis about which the adjacent commissure region pivots.

53. The heart valve of claim 52, wherein each commissure region terminates at a generally circular tip, the valve further including coupling members having a pair of spaced pins provided thereon that defined the first and second axes and about which the circular tips of each commissure region pivot.

54. The heart valve of claim 52, wherein the first and second axes are coincident.

55. The heart valve of claim 47, wherein each commissure region terminates at an arcuate tip, the valve further including coupling members having an arcuate channel therein, the coupling members receiving the arcuate tips of the commissure regions and permitting relative sliding movement about a pivot axis defined by the arcuate channel.

56. The heart valve of claim 47, wherein the valve includes a plurality of pliable coupling members each of which couples to a pair of adjacent commissure regions to permit relative movement therebetween.

57. The heart valve of claim 56, wherein each commissure region terminates at a generally linear tip, the pliable coupling members comprising pliable tubular sleeves closely fitting over the linear tips.

58. The heart valve of claim 46, wherein each stent member is coupled to move with respect to the other stent members about the stent commissures.

59. The heart valve of claim 58, wherein each stent member is pivotally coupled with respect to the other stent members at the stent commissures.

60. The heart valve of claim 58, wherein each stent member is flexibly coupled with respect to the other stent members at the stent commissures.

61. The heart valve of claim 60, wherein each stent member is elastically coupled with respect to the other stent members at the stent commissures.

2. A highly flexible heart valve, comprising:

a stent/leaflet subassembly including a peripheral stent and a plurality of leaflets disposed therewithin, the stent/leaflet subassembly including alternating cusps and commissures; and

a connecting band attached to the stent/leaflet subassembly and following the alternating cusps and commissures, the band having a free edge extending from the stent for connecting the heart valve to an anatomical orifice.

14. A prosthetic heart valve, comprising:

a plurality of flexible leaflets each having an arcuate cusp edge and a coapting edge; and

a stent including a plurality of cusps connected to each other at upstanding commissures to generally defined a substantially cylindrical volume therebetween, the leaflets being attached to the stent within the volume and the cusps being free to move with respect to one another about the commissures.

46. A prosthetic heart valve, comprising:

a stent including a plurality of stent members adjacently disposed around a circle to define a substantially cylindrical volume therebetween, the stent including a plurality of alternating cusps and commissures.

62. A holder for a prosthetic heart valve, comprising:

a central hub with a plurality of radially outward upper legs, and a plurality of lower legs angled downward and outward, the upper legs being adapted to connect to corresponding commissures of a prosthetic heart valve, and the lower legs being adapted to connect to corresponding cusps of the prosthetic heart valve.

63. The holder of claim 62, wherein the hub is internally threaded for mating with a handle.

64. The holder of claim 62, wherein each of the upper and lower legs includes structure to which sutures can be anchored.

65. The holder of claim 62, wherein each lower leg has a width from the hub to a terminal end that is greatest at the terminal end to provide more surface area to contact the corresponding valve cusp.

66. A prosthetic heart valve and implantation holder combination, comprising:

a flexible prosthetic heart valve having alternating cusps and commissures in a generally cylindrical configuration and adapted to move radially in and out with respect to one another; and

the rigid holder having structure for maintaining a fixed shape of the flexible prosthetic heart valve during implantation.

67. The combination of claim 66, wherein the holder includes a central hub with a plurality of radially outward upper legs, and a plurality of lower legs angled downward and outward, the upper legs being adapted to connect to corresponding commissures of the prosthetic heart valve, and the lower legs being adapted to connect to corresponding cusps of the prosthetic heart valve.

68. The combination of claim 67, wherein the hub is internally threaded for mating with a handle.

69. The combination of claim 66, structure on the holder for maintaining the fixed shape of the heart valve comprises a plurality of outwardly extending legs, the assembly further comprising a plurality of sutures attaching each leg to a portion on the heart valve.

70. The combination of claim 69, wherein each of the legs includes structure to which sutures can be anchored.

71. The combination of claim 69, wherein the holder includes one leg for each cusp and one leg for each commissure of the valve.

72. A heart valve leaflet, comprising:

a flexible, planar body having an arcuate cusp edge terminating at outer tips, and a coapting edge that is defined by two relatively angled lines joined at an apex directed away from the cusp edge midway between the two tips.

73. The heart valve of claim 72, wherein each leaflet is made of pericardial tissue.

74. The heart valve of claim 72, wherein the arcuate cusp edges gradually become asymptotic at the tips.

75. The heart valve of claim 72, further including an outwardly angled transition edge from the arcuate cusp edges to the tips.

76. The heart valve of claim 75, wherein a generally linear edge is defined between each outwardly angled transition edge and the corresponding tip defining a generally trapezoidal tab adjacent the tips.

77. A method of implantation of a heart valve, comprising:

providing a flexible heart valve having alternating cusps and commissures in a generally cylindrical configuration and adapted to move radially in out with respect to one another;

attaching a holder to the valve that restricts relative movement of the cusps and commissures;

positioning the heart valve in proximity to an anatomical orifice;

implanting the heart valve; and

disconnecting the holder from the heart valve.

78. The method of claim 77, wherein the flexible valve has an undulating suture band extending outwardly therefrom, and the step of implanting includes connecting the suture band up and down the aortic wall following the suture band shape.

79. The method of claim 77, wherein the holder has a central club and a plurality of outwardly extending legs each releasably connected to either a cusp or a commissure of the heart valve.

80. The method of claim 79, wherein the legs of the holder are spaced apart to provide visibility gaps therebetween facilitating the steps of positioning and implanting.