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Home Heart Surgery Artificial-heart-valve-made-by-vacuum-forming-technique

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 Artificial heart valve made by vacuum forming technique

Details
Inventors: Kolff, Willem J.;
Assignee: University of Utah (Salt Lake City, UT)
Primary Examiner: Weston; Caleb
Assistant Examiner:
Attorney, Agent or Firm: Workman, Nydegger & Jensen

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.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Reference is now made to the accompanying drawings wherein like parts are designated with like numerals throughout.
Referring specifically to FIGS.
1, 2a, and 2b, one presently preferred embodiment of the present invention includes an annular frame defined by a ring 11 having a diameter which is considerably larger than its axial length.
The ring 11 has an outer wall 13 and an inner wall 15.
Opposite longitudinal ends of the ring (see FIGS.
2a and 2b) are designated inflow end 17 and outflow end 19 to characterize the direction of axial flow through the valve.
Each of the ends 17 and 19 have annular lips 21 and 23, respectively, projecting radially outward from outer wall 13.
Lips 21 and 23 serve to provide snap-on connection means for connecting the valve to suitably contoured artificial aorta, atria or ventricles.
The inner wall 15 of the ring is provided with three rounded recesses 25, each of which extends angularly for approximately 120.
degree.
, as hereinafter more fully described.
Three seamless, flexible, membrane-like leaflet members 27 project from inner wall 15 to the radial center of ring 11.
Each leaflet has a pair of edges 29 (see FIG.
1) which converge to the center of the ring.
A slit is provided between the edges 29 of adjacent leaflets.
The slit or opening closes immediately so as to provide a seal against back flow through the ring 11 when the leaflets are unflexed.
Each of the leaflets 27 is curved so as to present a concave surface facing downstream and a convex surface facing upstream.
The recesses 25 (see FIGS.
2a and 2b) each form a continuous curved profile with a respective concave surface of a leaflet 27, the profile extending from the leaflet edges upstream along the concave surface of the leaflet 27 and then back downstream along its convex surface.
The adjacent pairs of edges 29 of leaflets 27 form three cusps which may reside in a common plane.
In the embodiment of FIG.
1, the plane of the cusps is situated just below the outlet lip 23, as shown best in FIGS



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