Stent valve and method of manufacturing same

• US 20060122693A1
• Filed: 10/17/2005
• Published: 06/08/2006
• Est. Priority Date: 05/10/2004
• Status: Abandoned Application

• Current Assignee: Baylis Medical Company Inc. (Boston Scientific Corporation)
• Original Assignee: Baylis Medical Company Inc. (Boston Scientific Corporation)
• Inventors: Gilad, Ran, Baylis, Frank, Biadillah, Youssef
• Application Number:
  US11/250,448
• Publication Number:
  US 20060122693A1
• Time in Patent Office: Days
• US Class Current: 623/1.240
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility

Abstract

A stent valve includes a scaffold, the scaffold including interlinked struts, the scaffold having a scaffold passageway extending substantially longitudinally therethrough. The stent valve also includes a valve leaflet extending at least partially across the scaffold passageway, the valve leaflet defining a leaflet periphery. At least a portion of the leaflet periphery extends integrally from at least a portion of at least one of the struts and at least a portion of the leaflet periphery is substantially parallel to the at least a portion of said at least one of said struts.

Claims

1. A stent valve, comprising:

a scaffold, said scaffold including interlinked struts, said scaffold having a scaffold passageway extending substantially longitudinally therethrough; and

a valve leaflet extending at least partially across said scaffold passageway, said valve leaflet defining a leaflet periphery;

wherein

at least a portion of said leaflet periphery extends integrally from at least a portion of at least one of said struts; and

said at least a portion of said leaflet periphery is substantially parallel to said at least a portion of said at least one of said struts.

2. A stent valve as defined in claim 1, wherein said at least a portion of said at least one of said struts extends substantially longitudinally.

3. A stent valve as defined in claim 1, further comprising another valve leaflet extending at least partially across said scaffold passageway, said other valve leaflet defining another leaflet periphery, wherein

at least a portion of said other leaflet periphery extends integrally from said at least a portion of said at least one of said struts;

and

said at least a portion of said other leaflet periphery is substantially parallel to said at least a portion of said at least one of said struts.

4. A stent valve as defined in claim 3, wherein said two valve leaflets intersect only at their leaflet peripheries.

5. A stent valve as defined in claim 1, further comprising a sheath mounted to said scaffold.

6. A stent valve as defined in claim 5, wherein said sheath is mounted to said scaffold so that at least some of said struts are embedded into said sheath.

7. A stent valve as defined in claim 6, wherein said at least one of said strut is at least in part embedded into said sheath.

8. A stent valve as defined in claim 7, wherein said at least a portion of said at least one of said struts is at least in part embedded into said sheath.

9. A stent valve as defined in claim 8, wherein said at least a portion of said at least one of said struts is embedded into said sheath.

10. A stent valve as defined in claim 6, wherein said scaffold is substantially radially expandable and is configurable into both a scaffold retracted and a scaffold expanded configuration, wherein in said scaffold retracted configuration, a diameter of said scaffold along at least a portion thereof is smaller than a diameter of said scaffold in said scaffold expanded configuration.

11. A stent valve as defined in claim 10, wherein said sheath allows a substantially radial movement of said struts between said scaffold expanded and said scaffold retracted configurations with said at least some of said struts remaining embedded in said sheath during said substantially radial movement.

12. A stent valve as defined in claim 11, wherein said struts form a cell perimeter of a plurality of adjacent cells, each of said cells having a sheath cell portion extending thereacross, at least one of said cells being configured such that there is substantially no longitudinal strain imparted on the corresponding sheath cell portion as said scaffold is moved between scaffold valve retracted and scaffold expanded configurations.

13. A stent valve as defined in claim 12, wherein said cell perimeter of said at least one of said cells includes said at least one of said strut.

14. A stent valve as defined in claim 5, wherein another portion of said leaflet periphery extends integrally from said sheath.

15. A stent valve as defined in claim 5, wherein said sheath includes a sheath material and said scaffold includes a scaffold material, said stent valve further comprising a binding layer of a binding substance positioned between at least a subset of said at least some of said struts and said sheath, said binding layer adhering to said scaffold material and to said sheath material with a binding force that is stronger than a binding force between said scaffold material and said sheath material.

16. A stent valve as defined in claim 15, wherein said sheath material includes a first polymer.

17. A stent valve as defined in claim 16, wherein said binding substance includes a second polymer.

18. A stent valve as defined in claim 17, wherein said first polymer includes a first polyurethane and said second polymer includes a second polyurethane different from said first polyurethane.

19. A stent valve as defined in claim 18, wherein the tensile modulus of elasticity of said second polyurethane is substantially larger than the tensile modulus of elasticity of said first polyurethane.

20. A stent valve as defined in claim 19, wherein the tensile modulus of elasticity of said second polyurethane is from about 1.5 to about 10 times larger than the tensile modulus of elasticity of said first polyurethane.

21. A stent valve as defined in claim 5, wherein said sheath is made of a sheath material, said sheath material including a biological tissue.

22. A stent valve as defined in claim 1, wherein said valve leaflet has a substantially non-uniform thickness.

23. A stent valve as defined in claim 1, wherein said valve leaflet includes a valve material and said scaffold includes a scaffold material, said stent valve further comprising a binding layer of a binding substance positioned between at least a subset of said at least some of said struts and said valve leaflet, said binding layer adhering to said scaffold material and to said valve material with a binding force that is stronger than a binding force between said scaffold material and said valve material.

24. A method for manufacturing a stent valve, said method comprising:

providing a scaffold having a scaffold passageway extending longitudinally therethrough, the scaffold including interlinked struts;

inserting a mandrel in at least a portion of the scaffold passageway, the mandrel having a valve leaflet forming surface for forming a valve leaflet within the scaffold passageway, the valve leaflet forming surface defining a forming surface peripheral edge, the forming surface peripheral edge including a leaflet-to-strut attachment forming section, the mandrel being inserted in the at least a portion of the scaffold passageway so that the leaflet-to-strut attachment forming section is substantially adjacent and substantially parallel to at least a portion of at least one of the struts; and

forming the valve leaflet by depositing a leaflet forming material onto the valve leaflet forming surface and onto the at least a portion of the at least one of the struts, the leaflet forming material being deposited so that the valve leaflet extends substantially inwardly into the scaffold passageway and integrally from the at least a portion of the at least one of the struts.

25. A method as defined in claim 24, wherein the at least a portion of the at least one of the struts extends substantially longitudinally.

26. A method as defined in claim 24, further comprising mounting a sheath to the scaffold.

27. A method as defined in claim 26, wherein said mounting of the sheath to the scaffold is performed so that at least some of the struts are embedded into the sheath.

28. A method as defined in claim 24, wherein said providing of the scaffold includes providing a substantially radially expandable scaffold, the scaffold being configurable into both a scaffold retracted and an expanded configuration, wherein in the scaffold retracted configuration, the diameter of the scaffold along at least a portion thereof is smaller than the diameter of the scaffold in the scaffold expanded configuration along the at least a portion thereof.

29. A method as defined in claim 28, further comprising mounting a sheath to the scaffold so that at least some of said struts are embedded into the sheath, the sheath allowing a substantially radial movement of the struts between the scaffold expanded and the scaffold retracted configurations with the at least some of the struts remaining embedded in the sheath during the substantially radial movement.

30. A method as defined in claim 29, wherein said mounting of the sheath to the scaffold is performed by depositing a polymer film on at least a portion of the scaffold.

31. A method as defined in claim 30, wherein said depositing of the polymer film on the scaffold includes at least one of dip-coating the scaffold in the polymer, spraying the scaffold with the polymer, molding the polymer around the scaffold, and positioning at least one sheet of the polymer so that at least part of the at least one sheet of the polymer is proximal to the scaffold and thereafter applying heat to fuse the first sheet to the scaffold.

32. A method as defined in claim 31, wherein said inserting of the mandrel in the at least a portion of the scaffold passageway is performed prior to said depositing of the polymer film.

33. A method as defined in claim 32, wherein the polymer film is deposited simultaneously on the scaffold and on the mandrel to form the valve leaflet.

34. A method as defined in claim 31, further comprising:

covering the valve forming surface with a water-soluble substance prior to said mounting of the valve.

dipping the mandrel and the stent valve in water after said deposition of the polymer film; and

removing the mandrel from the stent after the water has dissolved at least in part the water-soluble substance.

35. A method as defined in claim 26, further comprising expanding the stent valve prior to said mounting of the sheath.

36. A method as defined in claim 26, further comprising coating at least some of the struts with a binding substance prior to said forming of the sheath, the binding substance being a substance that increases a binding force between the at least some of the struts and the sheath.