Implantable prosthetic valve

• US 20020188348A1
• Filed: 07/09/2002
• Published: 12/12/2002
• Est. Priority Date: 10/21/1999
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: DiMatteo, Kristian, Marshall, Peter
• Granted Patent: US 6,685,739 B2
• Time in Patent Office: Days
• US Class Current: 623/1.24
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: Y10T 137/7886 Internally extending mount

Abstract

A prosthetic valve for implantation within a fluid conducting lumen within a body includes an elongate generally cylindrical radially collapsible valve body scaffold defining a fluid passageway therethrough for retentive positioning within the lumen. A radially collapsible leaf valve member is supported by the scaffold includes a number of valve leafs deflectable between a closed position restricting fluid flow through the passageway and an open position permitting fluid flow through the passageway. The leaf valve member includes an interior leaf valve frame defining a valve leaf aperture which is sealed by a fluid impermeable non-thrombogenic lining to prevent fluid flow therethrough.

Claims

1. A method of forming a prosthetic valve for implantation within a body lumen, comprising

providing a radially collapsible trellis having a tubular body scaffold portion defining an elongate fluid passageway for fluid flow therethrough and a valve leaflet frame portion having a number of valve leaf frames each defining a valve leaf frame aperture with the scaffold portion wherein said valve leaf frames are deflectable with respect to said scaffold portion so as to extend in overlying registry with the passageway between a first position and a second position, and

sealing each said valve leaf aperture with a biocompatible non-thrombogenic fluid impermeable material such that when the leaflet portion is in said first position, fluid flow through said passageway is substantially restricted.

2. The method of forming a prosthetic valve of claim 1, further comprising the steps of biasing each of said valve leaf frames towards the first position.

3. The method of forming a prosthetic valve of claim 1, further comprising the step of biasing said valve leaflet portion towards the second position whereby fluid flow through said passageway is permitted.

4. The method of forming a prosthetic valve of claim 1, further comprising the step of coating the material sealing each said valve leaf frame aperture with a growth inhibiting drug.

5. The method of forming a prosthetic valve of claim 1, further comprising the steps of

providing an elongate mandrel having a cylindrical outer surface;

positioning a first biocompatible non-thrombogenic fluid impermeable liner over the outer surface of the mandrel;

positioning said trellis over said first liner; and

affixing said first liner to said trellis.

6. The method of forming a prosthetic valve of claim 1, further comprising the step of forming a radially collapsible trellis having a shape memory.

7. The method of forming a prosthetic valve of claim 6, wherein the step of forming a radially collapsible trellis further includes

laying a wire in an undulating manner in the shape of a preform of the trellis.

8. The method of forming a prosthetic valve of claim 7, wherein the laying step further comprises the steps of alternately forming an aperture defined by a valve leaflet frame and said body scaffold and forming an opening defined by said scaffold portion.

9. The method of forming a prosthetic valve of claim 1, further comprising the step of deflecting each said leaflet frame portion with respect to the body scaffold portion component to impart a shape memory to the preform in one of said first and second positions.

10. The method of forming a prosthetic valve of claim 9, further comprising the step of imparting a curve to the leaflet frame.

11. The method of forming a prosthetic valve of claim 9, wherein the imparting step further comprises the step of

heat setting a shape memory alloy at a temperature above its austenitic start temperature in a desired shape.

12. The method of forming a prosthetic valve of claim 5, further comprising the step of

positioning a second biocompatible fluid impermeable non-thrombogenic liner over the scaffold.

13. The method of forming a prosthetic valve of claim 12, further comprising the step of positioning said second fluid impermeable liner opposite said first liner.

14. The method of forming a prosthetic valve of claim 12, further comprising the step of

positioning said second fluid impermeable liner to be substantially longitudinally coextensive with said first liner along said scaffold portion.

15. The method of forming of prosthetic valve of claim 14, wherein said step of positioning said second fluid impermeable liner opposite said first liner and substantially coextensive with said first liner along said scaffold portion further comprises positioning said second liner over said valve frame portion.

16. The method of forming a prosthetic valve of claim 1, further comprising the step of

providing anchoring means to the prosthesis for engaging a lumen wall upon emplacement at a selected site of a body lumen.

17. The method of forming a prosthetic valve of claim 1, further comprising the step of

providing an elongate mandrel having a cylindrical outer surface;

positioning said trellis over the outer surface of said mandrel; and

positioning a first biocompatible non-thrombogenic fluid impermeable liner over the outer surface of said trellis.

18. The method of forming a prosthetic valve of claim 1, further comprising the step of incorporating cultured tissue cells into said valve frame aperture.

19. The method of forming a prosthetic valve of claim 18, further comprising the step of covering each said valve leaf frame with cultured tissues.

20. The method of forming a prosthetic valve of claim 18, further comprising the step of

forming each said valve leaf frame from a bioabsorbable material to be displaced by said cultured tissue cells upon said cells maturing within the body lumen.

21. The method of forming a prosthetic valve of claim 18, further comprising the step of forming said trellis from a bioabsorbable material.

22. The method of forming a prosthetic valve of claim 18, further comprising the step of forming said trellis from a metallic material.

23. The method of forming a prosthetic valve of claim 22, further comprising the step of

forming said trellis from a shape memory material selected from the group consisting of an alloy of nickel and tin and a polymeric material.

24. The prosthetic valve of claim 1, further including a second radially collapsible open tubular scaffold having a cylindrical inner surface and an opposing cylindrical outer surface, said inner surface defining an elongate fluid conduit being substantially coaxially-aligned with said passageway of said valve, said second scaffold affixed to said body scaffold and extending at least one of said upstream and downstream direction from said valve.

25. The prosthetic valve of claim 1, wherein said second scaffold further includes a biocompatible fluid impermeable non-thrombogenic lining on at least one of said inner surface and said outer surface.