Simulated heart valve root for training and testing

• US 8,021,161 B2
• Filed: 05/01/2006
• Issued: 09/20/2011
• Est. Priority Date: 05/01/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Stobie, Robert, LaFrance, Hugues
• Primary Examiner(s): Thai; Xuan
• Assistant Examiner(s): Musselman; Timothy A
• Application Number:
  US11/414,954
• Publication Number:
  US 20070254273A1
• Time in Patent Office: 1,968 Days
• Field of Search: 434262-275, 623/1.24, 623/1.26, 623/1.1, 623/2.42
• US Class Current: 434/267
• 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 configured to realistically mimic a diseased annulus for use in simulated heart valve replacement surgery, 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, wherein the feature simulating an abnormal pathology comprises simulated calcification, and

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, and the nodes are made of a material that is harder than the tubular body.

2. The simulated human heart valve root of claim 1, wherein the tubular body has a Shore A hardness of between about 5A and 40A.