Artificial heart valve made by vacuum forming technique
First Claim
1. A method of manufacturing an artificial heart valve of the leaflet type having inflow and outflow sides, said method comprising the steps of:
- (a) preparing a mold having a region contoured to match one of said inflow and outflow sides of the leaflet valve to be manufactured;
(b) vacuum forming a first thin layer of thermoplastic elastomer material over said contoured region of the mold so as to form one of said inflow and outflow sides of said leaflet type valve;
(c) vacuum forming a second thin layer of thermoplastic elastomer material over said first layer so as to form the other of said inflow and outflow sides of said leaflet type valve; and
(d) removing said mold.
1 Assignment
0 Petitions
Accused Products
Abstract
An artificial heart valve having thin, seamless leaflets which converge to the center of a frame from the frame'"'"'s inner wall. The leaflets each have a convex outflow surface and a concave inflow surface. The leaflets meet along adjacent edges to form cusps. Sinus valsalvae sections of the valve are formed as rounded recesses defined in the valve frame'"'"'s inner wall as continuous curved profiles of the respective leaflet concave surfaces. The valve is fabricated by vacuum molding techniques whereby layers of elastomer are vacuum formed to comprise the leaflet and sinus valsalvae portions. In one embodiment, the leaflets are all formed from two or more layers of elastomer which are cut to define the leaflet edges or commissures. One elastomer layer extends along the frame recess to provide continuity for each leaflet and its sinus valsalvae. The resulting structure has no rims or seams in the inflow or outflow paths.
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Citations
11 Claims
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1. A method of manufacturing an artificial heart valve of the leaflet type having inflow and outflow sides, said method comprising the steps of:
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(a) preparing a mold having a region contoured to match one of said inflow and outflow sides of the leaflet valve to be manufactured; (b) vacuum forming a first thin layer of thermoplastic elastomer material over said contoured region of the mold so as to form one of said inflow and outflow sides of said leaflet type valve; (c) vacuum forming a second thin layer of thermoplastic elastomer material over said first layer so as to form the other of said inflow and outflow sides of said leaflet type valve; and (d) removing said mold.
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2. A method of manufacturing an artificial heart valve of the leaflet type having inflow and outflow sides, said method comprising the steps of:
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(a) preparing a first mold having a region contoured to match one of said inflow and outflow sides of the leaflet valve to be manufactured; (b) vacuum forming a first thin layer of thermoplastic elastomer material over said contoured region of the first mold; (c) positioning a second annular mold concentrically adjacent to said first mold; (d) vacuum forming a second thin layer of thermoplastic elastomer material over said first layer and over said second mold; and (e) removing said molds. - View Dependent Claims (3, 4, 5, 6)
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7. A method of manufacturing an artificial heart valve of the leaflet type having inflow and outflow sides, said method comprising the steps of:
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(a) preparing a mold having a region contoured to match one of said inflow and outflow sides of the valve to be manufactured; (b) positioning a ring member concentrically adjacent to said mold, said ring member being constructed of a polymer material so as to be bondable to thermoplastic elastomer material; (c) vacuum forming a thin layer of thermoplastic elastomer material over said mold and said ring member; and (d) removing said mold. - View Dependent Claims (8)
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9. A method of manufacturing an artificial heart valve of the leaflet type having inflow and outflow sides and in which flexible leaflet members extend radially inward from a frame formed by an elastomeric ring member, said leaflet members, when unflexed, meeting along adjacent edges to form cusps which point in a downstream direction and which extend substantially radially within the said frame, said method comprising the steps of:
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(a) preparing an elastomeric ring member with an inner wall and an outer wall, said inner wall having three concave recesses defined therein; (b) inserting a mold into said ring member, said mold being contoured to match the curvature of said leaflets; (c) vacuum forming a thin layer of elastomer material over said mold and said ring member; (d) removing said mold; and (e) cutting said layer along the adjacent leaflet edges which form the said cusps. - View Dependent Claims (10, 11)
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Specification