Implantable valve prosthesis

• US 9,775,704 B2
• Filed: 03/12/2007
• Issued: 10/03/2017
• Est. Priority Date: 04/23/2004
• Status: Active Grant

• Current Assignee: Medtronic 3F Therapeutics, Inc. (Medtronic Plc)
• Original Assignee: Medtronic 3F Therapeutics, Inc. (Medtronic Plc)
• Inventors: Bergheim, Bjarne, Myers, Keith E., DuMontelle, Jeffrey P., Nguyen, Christine
• Primary Examiner(s): PELLEGRINO, BRIAN E
• Application Number:
  US11/685,025
• Publication Number:
  US 20070270944A1
• Time in Patent Office: 3,858 Days
• Field of Search: 623 117, 623 124, 623 126, 623 214, 623 217, 623900, 623 238, 623 24, 623 241
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2002/0086 for preferentially controlling or promoting the growth of specific types of cells or tissues of bone tissue onto implantable joints A61F2002/3093
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 27/047 Other specific metals or alloys not covered by A61L27/042 - A61L27/045 or A61L27/06
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 27/3804 characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
• CPC Class Codes: A61L 27/3882 Hollow organs, e.g. bladder, esophagus, urether, uterus
• CPC Class Codes: A61L 27/50 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/507 : for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062

Abstract

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.

Claims

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.