Artificial heart valve made by vacuum forming technique

• US 4,510,628 A
• Filed: 05/13/1982
• Issued: 04/16/1985
• Est. Priority Date: 05/03/1982
• Status: Expired due to Fees

• Current Assignee: University of Utah (State of Utah)
• Original Assignee: University of Utah (State of Utah)
• Inventors: Kolff, Willem J.
• Primary Examiner(s): Apley, Richard J.
• Assistant Examiner(s): Isabella, David J.
• Application Number:
  US06/374,051
• Time in Patent Office: 1,069 Days
• Field of Search: 3/1.5, 156/242, 137/525.1, 137/525.3, 29/458
• US Class Current: 623/2.19
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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

Abstract

An artifical 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 valsalvae. The resulting structure has no rims or seams in the inflow or outflow paths.

Claims

1. An aritifical heart valve comprising means for forming an annular frame which defines an inflow end and an outflow end of said heart valve, and a plurality of thin leaflet members supported by said frame such that adjacent edges of each said leaflet member project radially inward toward the center of said frame to form a narrow slit between each leaflet pair through which blood flows from said inflow end to said outflow end, each leaflet member comprising a first discrete sheet of elastomeric material and a second discrete sheet of elastomeric material formed over said first sheet such that the only seam between said first and second sheets which occurs in the path of the blood as it flows from said inflow end to said outflow end occurs at said slits formed between each leaflet pair.

2. An artificial heart valve as defined in claim 1 said elastomeric sheets are bonded together.

3. An artifical heart valve as defined in claim 1 wherein each said leaflet member comprises a convex inflow surface and a concave outflow surface.

4. An artificial heart valve as defined in claim 3 wherein said annular frame comprises a ring member constructed of elastomeric material, said ring member being bonded to each said leaflet member.

5. An artificial heart valve as defined in claim 4 wherein said ring member has annular lips at said inflow and outflow ends to permit quick coupling to other artificial organs or tubes.

6. An artificial heart valve as defined in claim 4 wherein said ring member has an inner and an outer wall, and wherein the inner wall comprises a plurality of curved recesses each of which form an extension with said concave surface of one of the leaflet members.

7. An artificial heart valve comprising:

a ring member;

a plurality of thin leaflet members supported by said ring member such that adjacent edges of each said leaflet member project radially inward toward the center of said ring member to form a narrow slit between each leaflet pair, each leaflet member having an inflow surface and an outflow surface comprised of at least two thin, discrete sheets of elastomeric material bonded together so as to form discrete layers, and each leaflet member presenting a seamless, continuously curved profile at both the inflow and outflow surfaces thereof; and

said ring member being constructed of elastomeric material and being bonded to each said leaflet member, and said ring member having an inner surface which comprises a plurality of curved recesses each of which form a continuous extension of the curved profile of one of said leaflet members.

8. An Artificial heart valve comprising:

a ring member having radially inner and outer walls, and having an inlet end and an outlet end, each said end comprising means for forming a snap connection between the inflow and outflow ends of said ring member and other artificial organs or tubes connected to said ring member at the inflow and outflow ends thereof;

three flexible elastomeric leaflet members extending from respective adjacent locations disposed angularly about said inner wall, said leaflet members each having two edges which converge from said inner wall to a common point located substantially at the radial center of said annular member, each leaflet member, when unflexed, having its edges in contact with an edge of an adjacent leaflet member, each leaflet member having a curvature such that a concave surface of the leaflet member faces downstream toward said outlet end and the convex surface that faces upstream toward said inlet end; and

wherein said inner wall of said annular member is provided with rounded recesses, each recess forming a continuous curved profile with the concave surface of a respective leaflet member.

9. The valve according to claim 8 wherein each of said leaflet members comprises at least two discrete sheets of elastomeric material bonded together such that the only seam between said sheets which occurs in the path of blood flowing from said inlet end to said outlet end occurs at said edges which converge to said common point.

10. The valve according to claims 8 wherein said adjacent edges of said leaflet members are disposed substantially co-planar when said leaflet members are unflexed.

11. The valve according to claim 8 wherein said means for forming said snap connection at the inflow and outflow ends of said ring member comprises an annular lip at each said inflow and outflow end projecting radially outward for providing a snap-fit connection with other artificial organs or tubes.

12. An artificial heart valve comprising:

a ring member surrounding an area through which fluid flow is to be controlled, said ring member having an upstream side and a downstream side and inner and outer walls, said outer wall comprising an annular lip on the upstream and downstream sides thereof for providing a snap-connection to other artificial organs or tubes;

at least three thin, flexible elastomeric leaflet members extending from said inner wall to cover the surrounded area of said frame when unflexed, each leaflet member having a pair of edges, a concave surface facing downstream and a convex surface facing upstream;

at least three rounded recesses defined in said inner wall of said ring member, one recess for each leaflet member, each recess forming an extension of a continuous curved profile with the concave surface of a respective leaflet member; and

cusp means formed by adjacent edges of adjacent leaflet members for directing upstream flow around said continuous curved profiles and back downstream.

13. The valve according to claim 12 wherein each said leaflet member comprises at least two discrete sheets of thin elastomeric material bonded to one another such that the only seam between sheets occurs at said edges.