Implantable valve prosthesis
The present invention provides valve prostheses adapted to be initially crimped in a narrow configuration suitable for catheterization through body ducts to a target location and adapted to be deployed by exerting substantially radial forces from within by means of a deployment device to a deployed state in the target location.
1. A prosthetic valve assembly comprising:
a support structure having an inlet end and an outlet end, wherein the support structure includes a plurality of longitudinally rigid support beams, said support structure configured to be radially collapsible and expandable;
a valve comprising a pliant material having an inlet and an outlet, wherein said pliant material has a plurality of tabs at said outlet, and wherein said plurality of tabs are attached to said support beams at said outlet end of said support structure; and
a cuff operably attached to an outer surface of said support structure at said inlet of said support structure, wherein said cuff is disposed radially outside of said support beams, wherein said cuff has a radial lip configured to facilitate positioning and securing said valve assembly in a body lumen, wherein said cuff comprises a first cylindrical portion and a second cylindrical portion, said first cylindrical portion having greater thickness than said second cylindrical portion, wherein the first cylindrical portion is disposed downstream of the second cylindrical portion, and wherein said radial lip is defined by an interface of said first cylindrical portion and said second cylindrical portion.
2. The prosthetic valve assembly of claim 1 wherein said cuff comprises a material configured to facilitate tissue ingrowth.
3. The prosthetic valve assembly of claim 1 wherein said cuff comprises a cloth material.
4. The prosthetic valve assembly of claim 1 wherein said plurality of tabs are commissural tabs that are operably attached to eyelets on said outlet end of at least two of said plurality of longitudinally rigid support beams.
5. The prosthetic valve assembly of claim 4 wherein said plurality of tabs are sutured to said eyelets around a perimeter of each of said eyelets.
6. The prosthetic valve assembly of claim 1 further comprising cloth portions covering said plurality of tabs and said outlet end of said support structure.
7. The prosthetic valve assembly of claim 1 wherein said support structure comprises a material selected from the group consisting of memory shaped metals, memory shaped polymers, biocompatible stainless steel and polymeric material.
8. The prosthetic valve assembly of claim 7 wherein said support structure comprises polyethylene terphthalene.
9. The prosthetic valve assembly of claim 1 wherein said valve comprises at least two leaflets having tabs integrally formed thereon.
10. The prosthetic valve assembly of claim 9 wherein said leaflets comprise a material selected from the group consisting of natural tissue and biocompatible materials.
11. The prosthetic valve assembly of claim 10 wherein said natural tissue is pericardial tissue.
12. The prosthetic valve assembly of claim 10 wherein said biocompatible material is polyurethane.
13. The prosthetic valve assembly of claim 1 wherein said support structure is configured to be radially collapsible to a diameter of 4-25 mm while retaining a fixed longitudinal length.
14. The prosthetic valve assembly of claim 1 wherein said support structure is configured to be radially expandable to a diameter of 10-33 mm while retaining a fixed longitudinal length.
15. The prosthetic valve assembly of claim 1 wherein said support structure comprises an annular frame and said valve has a generally tubular shape, said valve having an outer diameter that is 1-5 mm smaller than an inner diameter of said support structure.
16. The prosthetic valve assembly of claim 1 wherein said valve comprises a tricuspid configuration.
17. The prosthetic valve assembly of claim 1 wherein said plurality of longitudinally rigid support beams are spaced equidistantly around said support structure.
18. The prosthetic valve assembly of claim 17 wherein said plurality of longitudinally rigid support beams are positioned parallel to one another.
19. The prosthetic valve assembly of claim 1 wherein said valve is attached to said cuff.
20. The prosthetic valve assembly of claim 1 wherein said plurality of longitudinally rigid support beams are attached to said support structure with rivets or an adhesive.
21. The prosthetic valve assembly of claim 1 wherein said plurality of longitudinally rigid support beams are integrally formed with said support structure.
22. The prosthetic valve assembly of claim 1 wherein said support structure has at least one marker configured to track and determine position and orientation of said prosthetic valve assembly.
23. The prosthetic valve assembly of claim 22 wherein said at least one marker comprises a metal selected from the group consisting of gold, platinum, iridium, tantalum, cobalt, chrome and titanium alloys.
24. The prosthetic valve assembly of claim 1 wherein said valve has a radio-opaque material at said outlet, said radio-opaque material configured to facilitate in vivo tracking of said valve assembly.
25. The prosthetic valve assembly of claim 24 wherein said radio-opaque material comprises gold thread.
26. The prosthetic valve assembly of claim 1 wherein said valve has collapsible slack portions at said outlet, said collapsible slack portions configured to allow blood to pass through said prosthetic valve assembly when flowing from said inlet end to said outlet thereby holding said collapsible slack portions in an open position, said collapsible slack portions further configured to prevent reverse blood flow by collapsing inwardly and maintaining said collapsible slack portions in a closed position.
27. The prosthetic valve assembly of claim 26 further comprising a strengthening wire disposed along said outlet of said valve and configured to support said collapsible slack portions.
28. The prosthetic valve assembly of claim 27 wherein said strengthening wire comprises nickel titanium.
29. A method for implanting a prosthetic valve assembly comprising:
(a) providing a catheter having a proximal end and a distal end;
(b) mounting said prosthetic valve assembly on said distal end, said prosthetic valve assembly comprising
(i) a support structure having an inlet end, an outlet end and a plurality of longitudinally rigid support beams disposed thereon, said support structure configured to be radially collapsible and expandable while retaining a fixed longitudinal length;
(ii) a valve comprised of a pliant material having an inlet end and an outlet, said pliant material having a plurality of tabs at said outlet configured to be operably attached to said support beams at said outlet end of said support structure; and
(iii) a cuff operably attached to an outer surface of said support structure at said inlet of said support structure, wherein said cuff is disposed radially outside of said support beams, wherein said cuff has a radial lip configured to facilitate positioning and securing said valve assembly in a body lumen, wherein said cuff comprises a first cylindrical portion and a second cylindrical portion, said first cylindrical portion having greater thickness than said second cylindrical portion, wherein the first cylindrical portion is disposed downstream of the second cylindrical portion, and wherein said radial lip is defined by an interface of said first cylindrical portion and said second cylindrical portion;
(c) guiding said catheter through said body lumen to a target site with a guiding tool;
(d) deploying said prosthetic valve assembly at said target location; and
(e) retracting said catheter.
30. The method of claim 29 wherein said guiding tool comprises a guidewire.
31. The method of claim 29 wherein said cuff is comprised of a material configured to facilitate tissue ingrowth.
32. The method of claim 29 wherein said cuff comprises a cloth material.
33. The method of claim 29 wherein said plurality of tabs are commissural tabs that are operably attached to eyelets on said outlet end of at least two of said plurality of longitudinally rigid support beams.
34. The method of claim 33 further comprising suturing said plurality of tabs to said eyelets around a perimeter of each of said eyelets.
35. The method of claim 29 further comprising covering said plurality of tabs and said outlet end of said support structure with cloth portions for promoting tissue ingrowth.
36. The method of claim 29 wherein said support structure comprises a material selected from the group consisting of memory shaped metals, memory shaped polymers, biocompatible stainless steel and polymeric material.
37. The method of claim 36 wherein said support structure comprises polyethylene terphthalene.
38. The method of claim 29 wherein said valve comprises at least two leaflets having tabs integrally formed thereon.
39. The method of claim 38 wherein said leaflets comprise a material selected from the group consisting of natural tissue and biocompatible materials.
40. The method of claim 39 wherein said natural tissue is pericardial tissue.
41. The method of claim 39 wherein said biocompatible material is polyurethane.
42. The method of claim 29 wherein the step for guiding said catheter through said body lumen to a target site with said guiding tool further comprises radially collapsing said prosthetic valve assembly to a diameter of 4-25 mm while maintaining a fixed longitudinal length of said prosthetic valve assembly.
43. The method of claim 29 wherein the step for deploying said prosthetic valve assembly at said target location further comprises radially expanding said prosthetic valve assembly to a diameter of 10-33 mm while retaining a fixed longitudinal length of said prosthetic valve assembly.
44. The method of claim 29 further comprising sizing said valve and said support structure to allow said valve to fully open and close without contacting said support structure.
45. The method of claim 29 wherein said valve comprises a tricuspid configuration.
46. The method of claim 29 wherein said plurality of longitudinally rigid support beams are spaced equidistantly around said support structure.
47. The method of claim 46 wherein said plurality of longitudinally rigid support beams are positioned parallel to one another.
48. The method of claim 29 further comprising adhering said plurality of longitudinally rigid support beams to said support structure with an adhesive.
49. The method of claim 29 further comprising attaching said plurality of longitudinally rigid support beams to said support structure with rivets.
50. The method of claim 29 further comprising integrally forming said plurality of longitudinally rigid support beams with said support structure.
51. The method of claim 29 further comprising providing at least one marker configured to track and determine position and orientation of said prosthetic valve assembly.
52. The method of claim 51 wherein said at least one marker comprises a metal selected from the group consisting of gold, platinum, iridium, tantalum, cobalt, chrome and titanium alloys.
53. The method of claim 29 wherein said valve has a radio-opaque material at said outlet for facilitating in vivo tracking of said valve assembly.
54. The method of claim 53 wherein said radio-opaque material comprises gold thread.
55. The method of claim 29 further comprising attaching said valve to said support structure with at least one U-shaped rigid member wherein said plurality of longitudinally rigid support beams have bores configured to receive extruded portions of at least one U-shaped rigid member.
56. The method of claim 29 wherein said plurality of longitudinally rigid support beams comprise a frame construction having a plurality of gaps therewithin, and further wherein said pliant material is inserted in at least one of said plurality of gaps.
57. The method of claim 56 further comprising a fastening rod insertable through a pocket formed between said pliant material and said frame construction.
58. The method of claim 29 wherein said support structure comprises a coiled wire coated with a coating material.
59. The method of claim 58 wherein said coating material comprises polyurethane.
60. The method of claim 29 wherein said valve has collapsible slack portions at said outlet, said collapsible portions configured to allow blood to pass through said prosthetic valve assembly when flowing from said inlet end to said outlet thereby holding said collapsible portions in an open position, said collapsible portions further configured to prevent reverse blood flow by collapsing inwardly and maintaining said collapsible portions in a closed position.
61. The method of claim 60 further comprising a strengthening wire disposed along said outlet of said valve for supporting said collapsible portions.
62. The method of claim 61 wherein said strengthening wire comprises nickel titanium.
63. The method of claim 29 further comprising at least one inflatable portion on said distal end of said catheter, said inflatable portion configured to radially expand said prosthetic valve assembly for deploying said prosthetic valve assembly at said target location.
64. The method of claim 29 wherein said support structure is radially self expanding for deploying said prosthetic valve assembly at said target location.