Method of manufacturing natural tissue valves having variably compliant leaflets

• US 5,769,780 A
• Filed: 10/09/1997
• Issued: 06/23/1998
• Est. Priority Date: 09/02/1994
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Baxter International Inc.
• Inventors: Sung, Hsing-Wen, Hata, Cary, Tu, Roger, Shen, Shih-Hwa
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US08/948,365
• Time in Patent Office: 257 Days
• Field of Search: 623/2, 623/11, 623/12, 623/901, 8/94.11, 600/36
• US Class Current: 600/36
• 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 2/2475 Venous valves
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device
• CPC Class Codes: Y10S 623/915 Method or apparatus for preparing biological material

Abstract

Variably compliant natural tissue valve leaflets and vascular bioprosthetics incorporating variably compliant leaflets are provided along with methods for their manufacture. The variably compliant leaflets are fixed with the leaflet base section under greater pressure than the leaflet tip section rendering them relatively stiff along the leaflet base section and more flexible at the leaflet tip section. The radially variable flexing characteristics of the valve leaflets promote even distribution of mechanical stress on the valve assembly during the cardiac cycle leading to improved hemodynamic performance while retarding the calcification of the leaflet tissue.

Claims

1. A process for fixing a natural tissue valve prosthesis having improved hemodynamic characteristics and resistance to calcification, said process comprising:

(a) obtaining a mammalian natural tissue valve assembly having a circumferential annular margin and one or more valve leaflets pivotally attached to said circumferential annular margin, each of said one or more valve leaflets including a leaflet base section adjacent to said circumferential annular margin and a leaflet tip section disposed radially therefrom;

(b) subjecting each of said leaflet base sections of said one or more valve leaflets to a higher pressure than each of said leaflet tip sections on the same side of the valve leaflet; and

(c) contacting each of said sections of said pressurized natural tissue valve assembly with a fixing agent.

2. The process of claim 1 wherein each of said leaflet base sections comprises from approximately 5% to approximately 80% of the length of each of said one or more valve leaflets measured radially from said circumferential annular margin.

3. The process of claim 1 wherein said fixing agent is selected from the group consisting of polyepoxy compounds, glutaraldehyde, formaldehyde and combinations thereof.

4. The process of claim 2 wherein said fixing agent is a polyepoxy compound and said polyepoxy compound is glycerol-polyglycidyl ether.

5. The process of claim 1 wherein said tissue valve assembly is selected from the group consisting of tri-leaflet valve assemblies and bileaflet valve assemblies.

6. The process of claim 1 wherein said pressure is applied intermittently to said valve leaflet while said natural tissue valve assembly is contacted with said fixing agent.

7. The process of claim 1 wherein said natural tissue valve assembly is a porcine valve assembly.

8. The process of claim 1 wherein said pressure is derived from contact force applied by a soft porous material.

12. The process of claim 8 wherein said natural tissue valve leaflet is derived from tissue selected from the group consisting of pericardial tissue, fascia lata membrane, and dura mater membrane.

13. The process of claim 1, wherein step (b) includes the step of retaining said leaflet base sections and said leaflet tip sections in separate chambers during the application of higher pressure to said leaflet base sections.

14. The process of claim 7, wherein step (b) includes the step of retaining said leaflet base sections and said leaflet tip sections in separate chambers during the application of higher pressure to said leaflet base sections.

15. The process of claim 1, wherein the leaflet base sections are subjected to a pressure created by contact with a solid body.

16. The process of claim 15, wherein the solid body is an exterior surface of a pressure bladder.

17. A process as in claim 1, further including positioning a rigid tube adjacent an outflow side of the valve leaflets, the tube being concentric with and spaced inwardly from the annular margin, wherein said step of subjecting comprises applying said higher pressure to the leaflet base sections outside of said tube.

18. A process as in claim 17, wherein the higher pressure is applied to said leaflet base sections by inflating a bladder positioned outside of the tube.

19. A process as in claim 18, wherein the natural tissue valve assembly being fixed is a tri-leaflet valve, and the process further includes providing three discrete bladders outside of the tube adjacent each leaflet for applying the higher pressure to said leaflet base sections.

20. A process as in claim 1, further comprising mounting the natural tissue valve prosthesis on a surrounding stent support prior to said step of subjecting.

9. A process for fixing a natural tissue valve leaflet having improved hemodynamic characteristics and resistance to calcification, said process comprising:

(a) providing a natural tissue valve leaflet having a leaflet base section and a leaflet tip section disposed adjacent thereto;

(b) subjecting said leaflet base section to a higher pressure than said leaflet tip section on the same side of the valve leaflet; and

(c) contacting each of said sections of said pressurized natural tissue valve leaflet with a fixing agent.

10. The process of claim 9 wherein said fixing agent is selected from the group consisting of polyepoxy compounds, glutaraldehyde, formaldehyde and combinations thereof.

11. The process of claim 10 wherein said fixing agent is a polyepoxy compound and said polyepoxy compound is a glycerol-polyglycidyl ether.

21. The process of claim 9, wherein the leaflet base sections are subjected to a pressure created by contact with a solid body.

22. The process of claim 21, wherein the solid body is an exterior surface of a pressure bladder.

23. A process as in claim 9, further including positioning a rigid tube adjacent an outflow side of the valve leaflets, the tube being concentric with and spaced inwardly from the annular margin, wherein said step of subjecting comprises applying said higher pressure to the leaflet base sections outside of said tube.

24. A process as in claim 23, wherein the higher pressure is applied to said leaflet base sections by inflating a bladder positioned outside of the tube.

25. A process as in claim 24, wherein the natural tissue valve assembly being fixed is a tri-leaflet valve, and the process further includes providing three discrete bladders outside of the tube adjacent each leaflet for applying the higher pressure to said leaflet base sections.

26. A process as in claim 9, further comprising mounting the natural tissue valve prosthesis on a surrounding stent support prior to said step of subjecting.

27. A process for fixing a natural tissue valve prosthesis having an annular margin and a plurality of leaflets extending generally radially inwardly from the margin, comprising:

securing the margin from movement;

positioning a tubular member concentrically within the margin and in contact with the leaflets on a downstream side thereof so as to bias the leaflets into a closed position, the tubular member being sized smaller than the margin so that a base section of each leaflet is exposed on the downstream side between the margin and tubular member and a tip section of each leaflet is disposed within the tubular member; and

subjecting the base section of the leaflets to a higher pressure than the tip section while contacting the natural tissue valve prosthesis with a fixing agent.

28. The process of claim 27, wherein the leaflet base sections are subjected to said higher pressure created by contact with a solid body.

29. A process as in claim 28, wherein the higher pressure is applied to said leaflet base sections by inflating a bladder positioned outside of the tubular member.

30. A process as in claim 29, wherein the natural tissue valve assembly being fixed is a tri-leaflet valve, and the process further includes providing three discrete bladders outside of the tubular member adjacent each leaflet for applying the higher pressure to said leaflet base section.

31. A process as in claim 27, wherein the tubular member includes three axial cutouts for receiving commissures of the natural tissue valve leaflets, and concave portions between the cutouts for contacting and biasing the leaflets.

32. A process as in claim 27, wherein the higher pressure is applied to said leaflet base sections by filling a closed space adjacent each base section with a compressible material and compacting the material against the base sections.

33. A process as in claim 27, wherein the natural tissue valve prosthesis includes a natural tubular wall portion extending on the downstream side of the annular margin, and wherein a pressure source is positioned between the tubular member and tubular wall portion to subject the leaflet base sections to the higher pressure.

34. A process as in claim 33, wherein the higher pressure is applied to the leaflet base sections by inflating a bladder positioned outside of the tubular member and inside of the tubular wall portion.

35. A process as in claim 34, further including subjecting the leaflet base sections to an intermittent higher pressure.

36. A process as in claim 27, further comprising mounting the natural tissue valve prosthesis on a surrounding stent support prior to said step of subjecting.