Method of testing bioprosthetic heart valve leaflets

• US 6,245,105 B1
• Filed: 12/09/1998
• Issued: 06/12/2001
• Est. Priority Date: 04/03/1997
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Nguyen, Than, Zhou, Jianbo, Lam, Hung Ly, Huynh, Van Le, Kafesjian, Ralph, Guo, Xiaoming G., Romero, Carlos M.
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US09/207,783
• Time in Patent Office: 916 Days
• Field of Search: 623/2, 623/912, 623/900, 623/2.12, 623/2.13, 738/653
• US Class Current: 623/2.13
• 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 2/2472 Devices for testing
• CPC Class Codes: A61M 25/0133 Tip steering devices
• CPC Class Codes: Y10S 623/90 Stent for heart valve
• CPC Class Codes: Y10S 623/91 Heart
• CPC Class Codes: Y10S 623/913 Heart

Abstract

Heart valve leaflet selection methods and apparatuses which subject individual leaflets to loads and measure the resulting deflection to more reliably group leaflets of similar physical characteristics for later assembly in prosthetic heart valves. The deflection testing may be accomplished using a variety of test set ups which are designed to impart a load on the leaflet which simulates the actual loading within a heart valve. The results from a number of deflection tests are used to categorize individual leaflets, which data can be combined with other data regarding the characteristics of the leaflet to better select leaflets for assembly into a multi-leaflet heart valve. In one embodiment, the deflection test is combined with an intrinsic load test, and leaflets having similar deflection and intrinsic load values used in the same heart valve. One apparatus for testing the leaflets includes a frame for securing the arcuate cusp of the leaflet while the straight coapting edge remains free, to simulate the actual leaflet mounting configuration within the heart valve prosthesis. The frame may include a lower portion having a recess for the leaflet and plurality of receptor holes around the peripheral edge of the recess, and an upper portion having a plurality of needles which extend downward through the leaflet and into the receptor holes and secure the edges of the leaflet.

Claims

1. A method of selecting leaflets for an implantable heart valve, comprising the steps of:

providing a collection of similarly sized leaflets;

applying a load to each leaflet;

observing the strain response in each leaflet from applying the load; and

sorting the leaflets based on their respective strain responses.

2. The method of claim 1, wherein the step of providing a collection includes providing a collection of natural tissue leaflets.

3. The method of claim 2, further including the step of chemically fixing the leaflets prior to testing.

4. The method of claim 2, wherein the step of providing a collection of natural tissue leaflets includes providing a collection of bovine pericardium leaflets.

5. The method of claim 1, wherein the step of providing a collection of leaflets includes providing a collection of leaflets having a matrix and natural tissue ingrowth.

6. The method of claim 1, wherein the step of providing a collection of leaflets includes providing a collection of leaflets having a substrate on which is formed a cell growth covering.

7. The method of claim 1, wherein the step of providing a collection of leaflets includes providing a collection of extruded collagen leaflets.

8. The method of claim 1, wherein the step of applying a load comprises applying a load sufficient to create an average stress in at least some of the leaflets within a generally linear, high modulus region of a stress/strain curve of the leaflet material.

9. The method of claim 1, further including the step of applying a load for a predetermined number of times prior to observing the strain response.

10. The method of claim 9, wherein the predetermined number is at least three.

11. The method of claim 1, further including the steps of:

performing an intrinsic load test on the leaflets; and

sorting the leaflets based on the intrinsic load test results.

12. The method of claim 1, wherein the step of sorting the leaflets comprises forming subgroups of leaflets having a strain response within a predetermined range.

13. The method of claim 12, wherein the step of forming subgroups of leaflets having a strain response within a predetermined range comprises a measuring a deflection of each leaflet resulting from applying a load thereto, and forming a subgroup of leaflets each having a deflection within about 0.030 inches of the others.

14. A method of testing a leaflet for use in an implantable heart valve, comprising the steps of:

mounting the leaflet in a framing assembly so that portions which are to be sutured in the valve are held stationary, wherein the leaflet defines a cusp edge and a coapted edge generally opposite the cusp edge, and the framing assembly includes an upper member and a lower member, the lower member having a recess for receiving at least the cusp edge of the leaflet, the upper member being shaped to mate over the recess, and the framing assembly defining a cavity circumscribed by the recess, the step of mounting including positioning the leaflet in the recess and piercing the leaflet cusp edge with needles extending between and supported from movement by the upper and lower members, to hold at least the cusp edge of the leaflet stationary;

applying a load to the leaflet in a location adapted to simulate a point at which an average load is applied in the valve; and

sensing the resulting strain in the leaflet.

15. The method of claim 14, wherein the leaflet is made of natural tissue and further including the step of chemically fixing the leaflet prior to testing.

16. The method of claim 14, wherein the step of applying a load comprises applying a mechanical deflector to an upper surface of the leaflet over the cavity.

17. The method of claim 14, further including the step of recording the sensed strain.

18. The method of claim 17, further including applying a load at least twice before recording the sensed strain.

19. The method of claim 14, further including testing a second leaflet and correlating the results of the applied load tests for the two leaflets.

20. The method of claim 14, further including the step of performing a droop test on the leaflet by extending the leaflet over the end of a structure, and observing the resulting droop of the extended end of the leaflet.

21. The method of claim 20, further including testing a second leaflet and correlating the results of the droop tests and applied load tests for the two leaflets.

22. The method of claim 14, wherein the leaflet is made of a leaflet material, and the step of applying a load comprises applying a load sufficient to stress the leaflet within a generally linear high modulus region of a stress/strain curve of the leaflet material.

23. The method of claim 14, wherein the step of applying a load comprises applying a load sufficient to stress the leaflet between 300 and 600 kPa.

24. The method of claim 14, wherein the location at which the load is applied comprises an idealized concentrated load point and the step of applying a load comprises applying a load to a distributed area of the leaflet.

25. The method of claim 14, wherein the leaflet is made of a matrix and natural tissue ingrowth.

26. The method of claim 14, wherein the leaflet is made of a substrate on which is formed a cell growth covering.

27. The method of claim 14, wherein the leaflet is made of extruded collagen.

28. A method of testing a leaflet for use in an implantable heart valve, wherein the leaflet defines a cusp edge and a coapting edge generally opposite the cusp edge, comprising the steps of:

positioning the leaflet in a frame assembly including an upper member and a lower member, the lower member having a recess for receiving and securing the cusp edge of the leaflet the user member being shaped to mate over the recess, and the framing assembly further defining a cavity circumscribed by the recess;

supporting the leaflet by piercing the leaflet cusp edge with needles extending between and supported from movement by the upper and lower members to hold at least the cusp edge of the leaflet stationary such that a mid-portion remains unsupported;

applying a load to the mid-portion of the leaflet; and

sensing the resulting strain at the mid-portion of the leaflet.

29. The method of claim 28, wherein the leaflet is made of natural tissue and further including the step of chemically fixing the leaflet prior to testing.

30. The method of claim 28, wherein the stop of applying a load comprises applying a mechanical deflector to the mid-point of the leaflet over the cavity.

31. The method of claim 28, further including the step of recording the sensed strain.

32. The method of claim 31, further including applying the load at least twice to the leaflet before recording the sensed strain.

33. The method of claim 28, further including testing a second leaflet and correlating the results of the applied load tests for the two leaflets.

34. The method of claim 28, further including the step of performing a droop test on the leaflet by extending the leaflet over the end of a structure, and observing the resulting droop of the extended end of the leaflet.

35. The method of claim 34, further including testing a second leaflet and correlating the results of the droop tests and applied load tests for the two leaflets.

36. The method of claim 28, wherein the leaflet is made of a leaflet material, and the step of applying a load comprises applying a load sufficient to stress the leaflet within a generally linear high modulus region of a stress/strain curve of the leaflet material.

37. The method of claim 28, wherein the step of applying a load comprises applying a load sufficient to stress the leaflet between 300 and 600 kPa.

38. The method of claim 28, wherein the location at which the load is applied comprises an idealized concentrated load point and the step of applying a load comprises applying a load to EL distributed area of the leaflet.

39. The method of claim 28, wherein the leaflet is made of a matrix and natural tissue ingrowth.

40. The method of claim 28, wherein the leaflet is made of a substrate on which is formed a cell growth coveting.

41. The method of claim 28, wherein the leaflet is made of extruded collagen.