Heart valve prosthesis and process for its production

• US 4,778,461 A
• Filed: 11/17/1986
• Issued: 10/18/1988
• Est. Priority Date: 11/23/1985
• Status: Expired due to Fees

• Current Assignee: Beiersdorf AG (maxingvest GmbH & Co. KGaA)
• Original Assignee: Beiersdorf AG (maxingvest GmbH & Co. KGaA)
• Inventors: Reul, Helmut, Pietsch, Hanns, Kartheus, Holger, Sachau, Gunther, Holtzmann, Hans-Joachim
• Primary Examiner(s): Frinks, Ronald L.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US06/931,755
• Time in Patent Office: 701 Days
• Field of Search: 623/2, 623/900
• US Class Current: 623/2.19
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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
• CPC Class Codes: A61L 27/02 Inorganic materials
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: A61L 33/0005 Use of materials characterised by their function or physical properties
• CPC Class Codes: A61L 33/068 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L33/062 takes precedence
• CPC Class Codes: B29C 41/14 Dipping a core B29C41/10 takes precedence
• CPC Class Codes: B29C 41/20 incorporating preformed parts or layers, e.g. moulding inserts or for coating articles
• CPC Class Codes: B29C 67/246 Moulding high reactive monomers or prepolymers, e.g. by reaction injection moulding [RIM], liquid injection moulding [LIM] casting monomers B29C39/006, mixing construction B29B7/74
• CPC Class Codes: B29C 70/68 by incorporating or moulding on preformed parts, e.g. inserts or layers , e.g. foam blocks mould constructions therefor B29C33/12; joining preformed parts by moulding B29C65/70
• CPC Class Codes: B29K 2083/005 LSR, i.e. liquid silicone rubbers, or derivatives thereof
• CPC Class Codes: C08L 75/04 Polyurethanes
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

A heart valve prosthesis for replacing the aortic valve or the pulmonary valve, consisting of a support ring with at least two commissure supports in each case and flexible cusps, is characterized in that the height of the support ring including the commissure supports is less than the total height of the heart valve prosthesis.

Claims

1. A heart valve prosthesis for replacing the aortic valve or pulmonary valve, comprising at least two flexible cusps having an upper edge boundary at an upper portion of the heart valve prosthesis with a highest point, and a support ring with at least two commissure supports at an upper portion of the ring and said commissures having an upper edge boundary with a highest point, and wherein the height of the highest point of the commissure supports is 20 to 80% of the height of the highest point of the cusps.

2. A heart valve prosthesis according to claim 1, wherein the height of the support ring including the commissure supports is 40 to 60 of the total height of the heart valve prosthesis.

3. A heart valve prosthesis according to claim 1, wherein all construction lines and surfaces are formed by straight lines, circles, planes and spheres, the transitions of which are adapted by rounding radii, so that all edges, corners and transitions are rounded, in such a way that the mathematical functions underlying these construction lines are steady and fully differentiable.

4. A heart valve prosthesis according to claim 1, wherein the valve has three flexible, inwardly curved cusps and three commissure supports, and the boundary edges of the cusps in plan view show the outline of a symmetrical three-pointed star, the rays of which each comprise two adjacent, mutually parallel boundary edges.

5. A heart valve prosthesis according to claim 1, wherein the boundary edges of the cusps are located on an imaginary spherical surface, in such a way that the point of intersection of the three pairs of cusp edges is at the lowest point.

6. A heart valve prosthesis according to claim 1, wherein the boundary edges of the cusps are rounded and have a lobar outline in cross-section.

7. A heart valve prosthesis according to claim 1, wherein the support ring and the cusps are formed integrally as a result of the plastic skin, from which the cusps are formed, also enclosing the support ring.

8. A heart valve prosthesis according to claim 1, wherein the support ring is composed of a material selected from the group consisting of stainless steel, titanium, niobium, tantalum, aluminium, vitreous carbon, fused silica, silicate glass, sintered calcium phosphate ceramics, sintered titanium dioxide ceramics, sintered zirconium dioxide ceramics and a thermoplastic, the deflection temperature of which under load is above 150°

C.

9. A heart valve according to claim 8, wherein the deflection temperature is between 150°

and 250°

C.

10. A heart valve prosthesis according to claim 8, wherein the support ring is composed of a material selected from the group consisting of nylon 6, nylon 6,6, nylon 6,10, nylon 12, polyethylene glycol terephthalate (polyester), polyether-sulfone, polyoxymethylene, polyurethane, and polycarbonate.

11. A heart valve prosthesis according to claim 10, wherein the support ring contains up to 50% by weight of glass fibers.

12. A heart valve prosthesis according to claim 10, wherein the support ring comprises nylon 6,6 with 15% by weight of glass fibres.

13. A heart valve prosthesis according to claim 1, wherein the cusps comprise a three-dimensionally crosslinked flexible material which is insoluble in all organic solvents and in water and has a Shore A hardness of 20-80.

14. A hear valve prosthesis according to claim 13, wherein the cusps comprise an insoluble polyether-urethane crosslinked with γ

-aminopropyltris-alkoxysilane and having a Shore A hardness of 60-80.

15. A heart valve prosthesis according to claim 13, wherein the cusps comprise a polydimethylsiloxane which has been three-dimensionally crosslinked at high temperature and which can contain up to 25% of active silica and has a Shore A hardness of 25-60 and a minimum breaking strength of 8 N/mm².