Simulated heart valve root for training and testing

• US 20070254273A1
• Filed: 05/01/2006
• Published: 11/01/2007
• Est. Priority Date: 05/01/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Stobie, Robert, LaFrance, Hugues
• Granted Patent: US 8,021,161 B2
• Time in Patent Office: Days
• US Class Current: 434/272
• CPC Class Codes: A61F 2/2472 Devices for testing
• CPC Class Codes: G09B 23/32 with moving parts

Abstract

A simulated heart valve root used for training physicians in techniques of implantation of prosthetic heart valves as well as for more realistically testing the efficacy of prosthetic heart valves. The simulated heart valve root is made of the flexible, tubular body having an inner wall defining an annular ledge within which the prosthetic heart valve is implanted. Discrete nodes or areas of simulated calcification may be provided on the annular ledge. A simulated aortic root includes alternating cusps and commissures with calcification simulated at least at one of the commissures. A tear in the annular ledge may also be provided which simulates a tear that might occur from a valvuloplasty procedure. A reinforcing sleeve may surround the flexible tubular body to provide rigidity or hoop strength thereto. A method of testing includes mounting the simulated heart valve root in a flow conduit, implanting a prosthetic heart valve in the root, applying pulsatile flow to the assembly, and monitoring for leaks. The simulated heart valve root may also be incorporated within a larger simulated heart for use in training physicians to remotely implant prosthetic heart valves.

Claims

1. A simulated human heart valve root, comprising:

a flexible, generally tubular body having an inner wall defining an annular ledge; and

a feature simulating an abnormal pathology incorporated into the annular ledge.

2. The simulated human heart valve root of claim 1, wherein the feature simulating an abnormal pathology comprises simulated calcification.

3. The simulated human heart valve root of claim 2, wherein the simulated calcification is provided by at least one discrete node made of a material that is harder than the tubular body.

4. The simulated human heart valve root of claim 2, wherein the tubular body has a Shore A hardness of between about 5 A and 40 A and the simulated calcification is made of a material that is harder than the tubular body.

5. The simulated human heart valve root of claim 3, wherein the heart valve root is an aortic root such that the annular ledge has alternating cusps and commissures, and wherein the simulated calcification is provided by a plurality of discrete nodes distributed around the annular ledge, at least one of which is located at one of the commissures.

6. The simulated human heart valve root of claim 2, wherein the simulated calcification is provided by areas of hardness around the annular ledge.

7. The simulated human heart valve root of claim 1, wherein the feature simulating an abnormal pathology comprises a tear in the annular ledge.

8. The simulated human heart valve root of claim 7, further including simulated calcification in the annular ledge.

9. A simulated human heart valve root system, comprising:

a flexible, generally tubular body having an inner wall defining an annular ledge; and

a reinforcing sleeve surrounding the tubular body that has greater hoop strength than the tubular body.

10. The simulated human heart valve root system of claim 9, wherein the reinforcing sleeve is made of the material is harder than the material of the tubular body.

11. The simulated human heart valve root system of claim 9, wherein the reinforcing sleeve is molded around the tubular body so as to be in intimate contact with the entire exterior wall of the tubular body.

12. The simulated human heart valve root system of claim 9, wherein the reinforcing sleeve comprises an outer sleeve made of a rigid material and an intermediate sleeve formed of a hardenable material poured into an annular space between the outer sleeve and the tubular body.

13. The simulated human heart valve root system of claim 9, further including a feature simulating an abnormal pathology incorporated into the annular ledge.

14. The simulated human heart valve system of claim 13, wherein the feature simulating an abnormal pathology comprises a tear in the annular ledge.

15. The simulated human heart valve system of claim 14, further including simulated calcification in the annular ledge.

16. The simulated human heart valve system of claim 13, wherein the feature simulating an abnormal pathology comprises simulated calcification, and wherein the tubular body has a Shore A hardness of between about 5 A and 40 A and the simulated calcification is made of a material that is harder than the tubular body.

17. A method of testing a prosthetic heart valve, comprising:

providing a simulated heart valve root including a tubular body formed of a flexible material and defining an annular ledge including a feature simulating an abnormal pathology incorporated into the annular ledge;

securing a prosthetic heart valve to be tested within the heart valve root; and

applying pulsatile flow to the prosthetic heart valve within the heart valve root.

18. The method of claim 17, further including monitoring for leaks around the periphery of the prosthetic heart valve within the heart valve root.

19. The method of claim 17, wherein the feature simulating an abnormal pathology comprises simulated calcification.

20. The method of claim 17, wherein the feature simulating an abnormal pathology comprises a tear in the annular ledge.