Test device for and method of testing rapid assembly tissue heart valve

• US 5,662,705 A
• Filed: 03/07/1996
• Issued: 09/02/1997
• 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:
  US08/610,809
• Time in Patent Office: 544 Days
• Field of Search: 623/2, 623/900, 623/901, 73/37, 73/865.6
• US Class Current: 128/898
• 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 method of manufacturing and testing a tissue heart valve during open heart surgery is disclosed. A piece of autologous tissue from the body of the patient is precisely cut according to the size of the open annulus remaining after excision of the patient'"'"'s heart valve, with a plurality of holes being formed in the tissue. The tissue is situated between appropriately selected first and second stents so that the holes are registered with corresponding tissue alignment members in one of the stents, and the stents are positioned together to securely clamp the tissue therebetween. The constructed tissue heart valve is then mounted in a test chamber and visually inspected for leakage.

Claims

1. A method of testing a tissue heart valve during open heart surgery, the tissue heart valve being manufactured during the open heart surgery, comprising the steps of:

using a tissue sizing template as a guide to cut a piece of a patient'"'"'s tissue into a roughly-dimensioned piece of tissue;

utilizing a precisely configured cutting die including ferrules and a substantially continuous blade having a plurality of curved edges enclosing a predetermined space, said blade mounted in a substrate, to cut the roughly-dimensioned piece of tissue into a precisely-cut tissue having a plurality of holes configured to be registered with corresponding tissue alignment members and having a size appropriate for a measured annulus of the patient'"'"'s heart so that the tissue may be mounted between first and second stents, one of said stents having a plurality of tissue alignment members, without any additional cutting or trimming;

situating the precisely-cut tissue between the first and second stents and registering the plurality of holes in said tissue with corresponding tissue alignment members, thereby preventing the tissue from substantially moving during valve assembly;

positioning the stents together to securely clamp the tissue therebetween thereby forming a heart valve;

mounting the constructed tissue heart valve in a test chamber;

displacing a volume of solution through the heart valve in a primary direction of blood flow; and

visually inspecting the heart valve for any leakage through the heart valve after the solution has been displaced through the valve.

2. A method of testing a tissue heart valve during open heart surgery in which the tissue heart valve, manufactured during the open heart surgery, is sized to the open annulus remaining after the patient'"'"'s heart valve has been excised, comprising the steps of:

using a tissue sizing template as a guide to cut a piece of a patient'"'"'s tissue into a roughly-dimensioned piece of tissue;

utilizing an appropriately sized and precisely configured cutting die including ferrules and a substantially continuous blade enclosing a predetermined space and having curved edges, said blade mounted in a substrate, to cut the roughly-dimensioned piece of tissue into an appropriately sized and precisely-cut tissue having a plurality of holes configured to be registered with corresponding tissue alignment members so that the tissue may be mounted between appropriately sized first and second stents, one of said stents having a plurality of tissue alignment members, without any additional cutting or trimming;

situating the tissue between the first and second stents and registering the plurality of holes in said tissue with corresponding tissue alignment members, thereby preventing the tissue from substantially moving during valve assembly;

positioning the stents together to securely clamp the tissue therebetween thereby forming a heart valve;

mounting the constructed tissue heart valve on an appropriately sized mount in a test chamber;

displacing a volume of solution through the heart valve in a primary direction of blood flow; and

visually inspecting the heart valve for any leakage through the heart valve after the solution has been displaced through the valve.

3. A method of testing a tissue heart valve during open heart surgery in which the tissue heart valve, manufactured during the open heart surgery, is sized to the open annulus remaining after the patient'"'"'s heart valve has been excised, comprising the steps of:

cutting a piece of autologous tissue from the body of the patient during said open heart surgery;

cutting said piece of autologous tissue into an appropriately sized and precisely-cut tissue having a plurality of holes configured to be registered with corresponding tissue alignment members of an appropriately sized first stent so that the tissue may be mounted between appropriately sized first and second stents without any additional cutting or trimming;

situating the tissue between the first and second stents and registering the plurality of holes in said tissue with corresponding tissue alignment members of said first stent, thereby preventing the tissue from substantially moving during valve assembly;

positioning the stents together to securely clamp the tissue therebetween thereby forming a heart valve;

mounting the constructed tissue heart valve on an appropriately sized mount in a test chamber;

displacing a volume of solution through the heart valve in a primary direction of fluid flow; and

visually inspecting the heart valve for any leakage through the heart valve after the solution has been displaced through the valve.