Simulated heat and valve root for training and testing

• US 20070269784A1
• Filed: 05/01/2006
• Published: 11/22/2007
• Est. Priority Date: 05/01/2006
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Stobie, Robert, LaFrance, Hugues
• Application Number:
  US11/414,953
• Publication Number:
  US 20070269784A1
• Time in Patent Office: Days
• US Class Current: 434/272
• CPC Class Codes: G09B 23/285 for injections, endoscopy, bronchoscopy, sigmoidscopy, insertion of contraceptive devices or enemas
• CPC Class Codes: G09B 23/34 with removable 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 system for training a physician to implant a prosthetic heart valve, including:

a simulated heart defined by an entire simulated heart or portion thereof; and

a simulated heart valve root mounted in the simulated heart open to an access port for introducing a prosthetic heart valve, the simulated heart valve root including a tubular body formed of a flexible material and defining an annular ledge.

2. The system of claim 1, wherein the annular ledge of the simulated heart valve root further includes a feature simulating an abnormal pathology.

3. The system of claim 2, wherein the feature simulating an abnormal anthology is selected from the group consisting of:

simulated calcification; and

a simulated tear in the annular ledge.

4. The system of claim 1, wherein the feature simulating an abnormal pathology is radiopaque and the flexible material is not.

5. The system of claim 1, further including a means for vibrating the simulated heart.

6. The system of claim 1, further including a simulated radiopaque rib cage over the simulated heart.

7. The system of claim 6, further including simulated tissue associated with the rib cage and an incision in the simulated tissue leading to the access port.

8. A method of training a physician to implant a prosthetic heart valve, including:

providing a simulated heart valve root including a tubular body formed of a flexible material and defining an annular ledge;

mounting the heart valve root in a fixture having an access port; and

instructing the physician in delivering and implanting a prosthetic heart valve within the heart valve root.

9. The method of claim 8, further including blocking direct visual access to the heart valve root and providing a system for indirectly visualizing the step of delivering and implanting the prosthetic heart valve.

10. The method of claim 9, wherein the annular ledge of the simulated heart valve root further includes a radiopaque feature simulating an abnormal pathology, and the system for indirectly visualizing can distinguish between radiopaque and non-radiopaque materials.

11. The method of claim 8, wherein the fixture comprises a simulated heart including an entire simulated heart or portion thereof.

12. The method of claim 11, further including providing at least one additional radiopaque anatomical feature adjacent the simulated heart selected from the group consisting of:

ribs; and

the spine

13. The method of claim 8, further including subjecting the fixture to vibratory motion.

14. The method of claim 8, further including flowing fluid through the simulated heart valve root.

15. A method of training a physician to implant a prosthetic heart valve, including:

providing a simulated heart valve root including a tubular body formed of a flexible material and defining an annular ledge;

mounting the heart valve root in a simulated heart including an entire simulated heart or portion thereof which blocks direct visual access to the heart valve root; and

providing a system for indirectly visualizing the heart valve root.

16. The method of claim 15, wherein the annular ledge of the simulated heart valve root further includes a feature simulating an abnormal pathology.

17. The method of claim 16, wherein the system for indirectly visualizing the heart valve root can distinguish between the feature and the flexible material.

18. The method of claim 15, further including providing at least one further radiopaque anatomical feature adjacent the simulated heart selected from the group consisting of:

ribs; and

the spine

19. The method of claim 15, further including subjecting the simulated heart valve root to vibratory motion.

20. The method of claim 15, wherein the simulated heart valve root is mounted within a conduit, and further including flowing fluid through the conduit.