Test device for and method of testing rapid tissue heart valve

• US 5,584,878 A
• Filed: 06/06/1995
• Issued: 12/17/1996
• Est. Priority Date: 01/24/1991
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Autogenics Co.
• Inventors: Love, Jack W., Love, Charles S., Calvin, John H.
• Primary Examiner(s): Willse, David H.
• Application Number:
  US08/472,986
• Time in Patent Office: 560 Days
• Field of Search: 623/2, 623/900, 623/901, 73/37, 73/865.6
• US Class Current: 73/37
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2472 Devices for testing
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: Y10S 623/90 Stent for heart valve
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device
• CPC Class Codes: Y10S 623/91 Heart
• CPC Class Codes: Y10S 623/913 Heart
• CPC Class Codes: Y10S 623/918 Heart
• CPC Class Codes: Y10T 137/7857 Valve seat clamped between coupling elements
• CPC Class Codes: Y10T 29/49405 Valve or choke making

Abstract

A concentric mating stent tissue heart valve which is capable of being assembled with a variety of tissue sources is provided. A tester for rapidly testing a tissue heart valve is provided comprising a substantially transparent viewing chamber having a plurality of size-specific mounts for mounting the valve within the chamber. The tester further comprises an element for displacing a volume of solution through the valve to test the opening and closing of the valve and to determine the amount of leakage through the valve when the valve is in a closed position.

Claims

1. A tester for rapidly testing a tissue heart valve comprising:

a chamber substantially made of a transparent material which allows the user of the chamber to visually inspect the sides and top-end view of a mounted heart valve;

a plurality of size-specific mounts for mounting the valve within the chamber;

means coupled to the chamber for displacing a volume of solution through the valve in a primary direction of blood flow to test both the opening and closing of the valve and to determine the amount of leakage through the valve when said valve is in a closed condition; and

a calibrated float coupled to said chamber calibrated to be in a safe zone when said valve is in a closed position and there is substantially no leakage through said valve.

2. A method of rapidly testing a tissue heart valve, comprising the following steps:

providing a valve testing device having a clear viewing chamber for permitting side visualization of a valve positioned therein and a plurality of size-specific mounts for mounting the valve within the chamber;

positioning a valve in the chamber so that the positioned valve can be visualized through said clear viewing chamber;

displacing a volume of a solution through the valve in a primary direction of blood flow to test both the opening and closing of the valve and to determine the amount of leakage through the valve when said valve is in a closed condition;

visually inspecting at least one end and the side of the valve for leakage through the valve after the solution has been displaced through the valve; and

viewing a calibrated float coupled to said chamber which is calibrated to be in a safe zone when there is substantially no leakage through said valve when said valve is in a closed position.