Multi-leaflet bioprosthetic heart valve

• US 5,961,549 A
• Filed: 04/03/1997
• Issued: 10/05/1999
• Est. Priority Date: 04/03/1997
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Baxter International Inc.
• Inventors: Nguyen, Than, Zhou, Jianbo, Lam, Hung Ly, Huynh, Van Le, Kafesjian, Ralph, Guo, Xiaoming G., Romero, Carlos M.
• Primary Examiner(s): Yu, Mickey
• Assistant Examiner(s): Cuddihy, Francis K.
• Application Number:
  US08/833,176
• Time in Patent Office: 915 Days
• Field of Search: 623/1, 623/2, 623/11, 623/12, 623/66, 623/13, 623/900
• US Class Current: 623/2.12
• 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 multi-leaflet bioprosthetic heart valve comprising a plurality of leaflets, wherein each of the leaflets has a measured deflection response within 0.030 inches of the other leaflets upon application of a load sufficient to stress each of the leaflets between 300 and 600 kPa.

2. The valve of claim 1, wherein each of the leaflets has a measured deflection rsponse within 0.003 inches of the other leaflets upon application of said load.

3. The valve of claim 1, wherein the leaflets are made of bovine percardium.

4. The valve of claim 3, wherein the leaflets are glutaraldehyde-fixed.

5. The valve of claim 1, wherein there are three leaflets in said valve.

6. The valve of claim 1, wherein each of the leaflets has an observed intrinsic load test response within a predetermined range of the other leaflets.

7. The valve of claim 1, wherein the leaflets are made of a matrix having a tissue ingrowth.

8. The valve of claim 1, wherein the leaflets are made of a substrate on which is formed a cell growth covering.

9. The valve of claim 1, wherein the leaflets are made of extruded collagen.

10. The valve of claim 1, wherein a load is applied to each individual leaflet prior to assembly in the valve for a predetermined number of times before observing the deflection response.

11. The valve of claim 1, wherein a load is applied to each individual leaflet prior to assembly in the valve by mounting the leaflet in a frame so that portions which are to be sutured in the valve are held stationery, and the load is applied to the leaflet in a location adapted to simulate a point at which an average load is applied in operation of the valve, whereupon the deflection response is observed.

12. A multi-leaflet bioprosthetic heart valve comprising a plurality of bovine pericardium leaflets, wherein each of the leaflets has a measured deflection response of between 0.17 and 0.34 inches upon application of a load sufficient to stress each of the leaflets between 300 and 600 kPa.

13. The valve of claim 12, wherein each of the leaflets has a measured deflection response within 0.030 inches of the other leaflets upon application of said load.

14. The valve of claim 13, wherein each of the leaflets has a measured deflection response within 0.003 inches of the other leaflets upon application of said load.

15. The valve of claim 12, wherein the load is applied to each of the leaflets in a location adapted to simulate a point at which an average load is applied in operation of the valve, whereupon the deflection response is observed.