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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
First Claim
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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.

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