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HEART VALVE PROSTHESIS AND METHOD OF MANUFACTURE

  • US 20110049757A1
  • Filed: 11/04/2010
  • Published: 03/03/2011
  • Est. Priority Date: 12/08/1999
  • Status: Active Grant
First Claim
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1. A method of making a cardiac valve prosthesis which includes a frame defining a blood flow axis substantially parallel to the flow of blood through the valve prosthesis and at least two flexible leaflets attached to the frame, the method comprising:

  • providing a mold having a cavity sized to accommodate the frame;

    inserting the frame into the mold;

    inserting the mold into an injection molding machine;

    injecting molten polymer into the cavity of the mold to form the at least two leaflets and bond the at least two leaflets to the frame, the cavity being shaped to form the at least two leaflets in a neutral position in a desired configuration, the at least two leaflets being configured to be movable from an open to a closed position, the at least two leaflets having a blood inlet side and a blood outlet side, the at least two leaflets being in the closed position when fluid pressure is applied to the outlet side, being in the open position when fluid pressure is applied to the inlet side and being in a neutral position intermediate the open and closed position in the absence of fluid pressure being applied to the leaflets, the at least two leaflets including a first leaflet having a surface contour such that when the first leaflet is in the neutral position an intersection of the first leaflet with at least one plane perpendicular to the blood flow axis forms a first composite wave, the first composite wave being substantially defined by a first wave combined with at least a second superimposed wave, the first wave having a first frequency, the second wave having a second frequency, the first frequency being different from the second frequency, the first composite wave providing multiple curves in the leaflet free edge, andwherein the frame is substantially cylindrical having first and second ends, one of the ends defining at least two scalloped edge portions separated by at least two posts, each post having a tip,wherein each leaflet has a fixed edge joined to a respective scalloped edge portion of the frame and a free edge extending substantially between the tips of two posts, andwherein when the at least two leaflets are in the neutral position the valve prosthesis has partially open commissures defined by an included angle between adjacent leaflet free edges that is in the range of 10 to 55°

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