Prosthetic heart valve

• US 5,258,023 A
• Filed: 02/12/1992
• Issued: 11/02/1993
• Est. Priority Date: 02/12/1992
• Status: Expired due to Fees

• Current Assignee: Reger Medical Development, Inc.
• Original Assignee: Reger Medical Development, Inc.
• Inventors: Reger, Vincent A.
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US07/834,416
• Time in Patent Office: 629 Days
• Field of Search: 623/2, 623/11, 623/66, 623/900
• US Class Current: 623/2.18
• 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
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: Y10S 623/90 Stent for heart valve
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

A novel long lasting prosthetic heart valve compatible with implantation in a human natural heart valve annulus. The prosthetic heart valve comprises a trileaflet heart valve apparatus which in form, dimension, and function resembles a human trileaflet heart valve, but which is formed of synthetic resinous material. A seamless supporting frame capable of annular deformation and limited perimetric expansion during each heartbeat is totally enveloped in an essentially biologically inert cylindrical cover to form a cusp supporting stent for the valve leaflet apparatus. The free top and bottom edges of the cylindrical cover are disposed on the exterior of the stent and everted outward to provide at least one sewing ring. Valve embodiments comprise aortic and mitral implantable valves. For the aortic implant, the outwardly everting free sewing ring forming edges are separated by circumferentially disposed compressible and expandable material which provides a pliable, compliant interface between the valve and the natural valve annulus at the implanting site. Valve sewing ring covers can be selectively impregnated with antibiotic medicants to substantially eliminate early post implant infection. Use of non-thrombogenic biochemically inert materials in a valve apparatus which mimics operation of a natural heart valve essentially eliminates the need for long term administration of anticoagulants.

Claims

1. A long lasting, biocompatible prosthetic heart valve which is used as a replacement valve for a natural valve excised from a native orifice and is patently permissive to liquid flow in a first direction and non-regurgently occlusive to liquid flow in the opposite direction said prosthetic heart valve comprising:

leaflet valve means comprising essentially non-thrombogenic biochemically inert material means, cusp means which comprise a plurality of cusps which are similar in shape, size, and function to cusps of a natural heart valve having compliant commissures at free edges superiorly disposed in the first direction from bases of said cusps, and stent attachment means comprising cusp supporting means which extend in the first direction to provide an attachment surface about each commissure and retreat inferiorly therefrom about adjoining cusp lines to provide an attachment surface about each cusp base and to thereby provide a non-occlusive passageway for liquid flow from within each cusp to natural vessel pathways in the region of attachment of the valve within the native orifice;

stent means comprising flexible, cylindrical frame means which provide structural support for the leaflet valve means and means for envelopingly covering the frame means, the covering means comprising essentially biochemically inert material means, central orifice means for snugly, insertably receiving and affixing the leaflet valve means within the stent means, and means for securing the long lasting prosthetic heart valve in the native orifice;

the flexible, cylindrical frame means being of substantially rectangular cross section and comprising base means alternately disposed between and seamlessly attached to means for providing support for the stent attachment means at the superiorly disposed position of the commissures, the base means substantially comprising arcs of a cylindrical band transversely disposed across a plane defined by the bases of the cusps and the support providing means comprising a pair of substantially symmetrical extending members which are seamlessly joined in the region of the attachment surface of each commissure and separated in the region adjoining the bases of the cusps thereby providing circumferential, deformable support in the plane of the bases of the cusps;

the covering means comprising at least one section of hollow cylindrical seamless material means which comprises a first hollow continuous end, a second hollow continuous end, interior wall means interposed between the leaflet valve means and means which define the exterior wall of the long lasting prosthetic heart valve;

said first and second hollow continuous ends being radially outwardly everted in the plane of the bases of the cusps to form the securing means which comprise at least one sewing ring, each sewing ring thereby comprising only contiguous and continuous connection with the exterior wall means.

2. The long lasting prosthetic heart valve according to claim 1 further comprising means for adjoining unitable parts of the long lasting prosthetic heart valve by stitching or other connecting means void of resins which release into the blood stream of a patient over a period of time.

3. The long lasting prosthetic heart valve according to claim 1 wherein the leaflet valve means comprise a trileaflet valve.

4. The long lasting prosthetic heart valve according to claim 1 wherein the cusp means comprise exposed side means having free margins which coapt, in combination with associated commissures, to close the valve thereby reducing wear on the cusps at contacting areas of the free margins.

5. The long lasting prosthetic heart valve according to claim 1 wherein the essentially biochemically inert material means of the leaflet valve means is combined with at least one biologically active impregnating substance from a group of biologically active substances consisting of antibiotics, anticoagulant medicants, endothelial cells and endothelial cell growth factors.

6. The long lasting prosthetic heart valve according to claim 1 wherein the leaflet valve means comprise valve means molded in the form of a human aortic valve.

7. The long lasting prosthetic heart valve according to claim 1 wherein the leaflet valve means comprise a unicast valve means.

8. The long lasting prosthetic heart valve according to claim 1 wherein the essentially biochemically inert material means comprise silicone.

9. The long lasting prosthetic heart valve according to claim 1 wherein the leaflet means comprise surface means which are functionally continuous and non-thrombogenic.

10. The long lasting prosthetic heart valve according to claim 1 wherein the cusp means and stent attachment means, in combination, comprise means for joining together in a smooth, seamless interface.

11. The long lasting prosthetic heart valve according to claim 1 wherein the cylindrical frame means comprise windows primarily disposed in the base means, said windows providing a reduction of weight of the frame and a plurality of orifices through which each sewing ring is affixed to the interior an exterior interfacing wall means.

12. The long lasting prosthetic heart valve according to claim 1 wherein said cylindrical frame means comprise interior and exterior surface means which in combination comprise a plurality of holes disposed therebetween for firmly anchoring the leaflet valve means to the stent.

13. The long lasting prosthetic heart valve according to claim 1 wherein the cylindrical frame comprises stainless steel.

14. The long lasting prosthetic heart valve according to claim 1 wherein the cylindrical frame comprises flexible resilient synthetic resinous material.

15. The long lasting prosthetic heart valve according to claim 1 wherein the cylindrical frame comprises graphite.

16. The long lasting prosthetic heart valve according to claim 1 wherein the cylindrical frame comprises pyrolytic carbon.

17. The long lasting prosthetic heart valve according to claim 1 wherein the enveloping cover means comprise tailored pocket means which conformably cover the substantially symmetrical extending members.

18. The long lasting prosthetic heart valve according to claim 17 wherein the tailored pocket means comprise mean for tightly sealing edges thereof.

19. The long lasting prosthetic heart valve according to claim 18 wherein said sealing means comprise means for suturing.

20. The long lasting prosthetic heart valve according to claim 18 wherein said sealing means comprise means for heat sealing the edges thereof.

22. The long lasting prosthetic heart valve according to claim 1 wherein said essentially biochemically inert material means of said covering means comprise PTFE.

23. The long lasting prosthetic heart valve according to claim 1 wherein said essentially biochemically inert material means comprise polyethylene glycol terephtalate.

24. The long lasting prosthetic heart valve according to claim 1 wherein said essentially biochemically inert material means comprise firm surface support means whereby sutures are firmly and securely affixed to the at least one sewing ring.

25. The long lasting prosthetic heart valve according to claim 1 wherein the sewing ring means comprise two separated sewing rings.

28. The long lasting prosthetic heart valve according to claim 1 wherein said covering means comprise means for covering the at least one sewing ring and for interfacing with tissue within the annulus from which a natural valve has been excised.

30. The long lasting prosthetic heart valve according to claim 28 wherein at least one sewing ring covering and interfacing means comprise means for variably incorporating surrounding tissue, said ring of soft material means comprising means having variable porosity and providing a predetermined balance between ease of removal of the ring of soft material means and prevention of infection.

31. The long lasting prosthetic heart valve according to claim 30 wherein variable incorporating means ring of soft material means comprise at least one impregnated biochemical selected form a group comprising antibiotics, anticoagulant medicants, and endothelial cell growth factors.

32. The long lasting prosthetic heart valve according to claim 1 wherein the sewing ring means comprise a single sewing ring wherein each of the outwardly everted ends are joined to form the single sewing ring.

21. A long lasting, biocompatible prosthetic heart valve which is used as a replacement valve for a natural valve excised from a native orifice and is patently permissive to liquid flow in a first direction and non-regurgently occlusive to liquid flow in the opposite direction, said prosthetic heart valve comprising:

leaflet valve means comprising essentially non-thrombogenic biochemically inert material means, cusp means which comprise a plurality of cusps which are similar in shape, size, and function to cusps of a natural heart valve having compliant commissures at free edges superiorly disposed in the first direction from bases of said cusps, and stent attachment means comprising cusp supporting means which extend in the first direction to provide an attachment surface about each commissure and retreat inferiorly therefrom about adjoining cusp lines to provide an attachment surface about each cusp base and to thereby provide a non-occlusive passageway for liquid flow from within each cusp to natural vessel pathways in the region of attachment of the valve within the native orifice;

stent means comprising flexible, cylindrical frame means which provide structural support for the leaflet valve means and means for envelopingly covering the frame means, the covering means comprising essentially biochemically inert material means, central orifice means for snugly, insertably receiving and affixing the leaflet valve means within the stent means, and means for securing the long lasting prosthetic heart valve in the native orifice said essentially biochemically inert material means comprising a porous material comprising at least one medically advantageous biochemical selected from a group of biochemicals consisting of antibiotics, anticoagulant medications, and endothelial cell growth factors

the flexible, cylindrical frame means being of substantially rectangular cross section and comprising base means alternately disposed between the seamlessly attached to means for providing support for the stent attachment means at the superiorly disposed position of the commissures, the base means substantially comprising arcs of a cylindrical band transversely disposed across a plane defined by the bases of the cusps and the support providing means comprising a pair of substantially symmetrical extending member which are seamlessly joined in the region of the attachment surface of each commissure and separated in the region adjoining the bases of the cusps thereby providing circumferential, deformable support in the plane of the bases of the cusps;

the covering means comprising at least one section of hollow cylindrical seamless material means which comprises a first hollow continuous end, a second hollow continuous end, interior wall means interposed between the leaflet valve means and means which define the exterior wall of the long lasting prosthetic heart valve;

said first and second hollow continuous ends being radially outwardly everted in the plane of the bases of the cusps to form the securing means which comprise at least one sewing ring, each sewing ring thereby comprising only contiguous and continuous connection with the exterior wall means.

26. A long lasting, biocompatible prosthetic heart valve which is used as a replacement valve for a natural valve excised form a native orifice and is patently permissive to liquid flow in a first direction and non-regurgently occlusive to liquid flow in the opposite direction, said prosthetic heart valve comprising:

leaflet valve means comprising essentially non-thrombogenic biochemically inert material means, cusp means which comprise a plurality of cusps which are similar in shape, size, and function to cusps of a natural heart valve having compliant commissures at free edges superiorly disposed in the first direction from bases of said cusps, and stent attachment means comprising cusp supporting means which extend in the first direction to provide an attachment surface about each commissure and retreat inferiorly therefrom about adjoining cusp lines to provide an attachment surface about each cusp base and to thereby provide a non-occlusive passageway for liquid flow from within each cusp to natural vessel pathways in the region of attachment of the valve within the native orifice, the leaflet valve means comprising surface means which are functionally continuous and non-thrombogenic;

stent means comprising flexible, cylindrical frame means which provide structural support for the leaflet valve means and means for envelopingly covering the frame means, the covering means comprising essentially biochemically inert material means, central orifice means for snugly, insertably receiving and affixing the leaflet valve means within the stent means, and means for securing the long lasting prosthetic valve in the native orifice;

the flexible, cylindrical frame means being of substantially rectangular cross section and comprising base means alternately disposed between and seamlessly attached to means for providing support for the stent attachment means at the superiorly disposed position of the commissures, the base means substantially comprising arcs of a cylindrical band transversely disposed across a plane defined by the based of the cusps and the support providing means comprising a pair of substantially symmetrical extending members which are seamlessly joined in the region of the attachment surface of each commissure and separated in the region adjoining the bases of the cusps thereby providing circumferential, deformable support in the plane of the bases of the cusps;

the covering means comprising at least one section of hollow cylindrical seamless material means which comprises a first hollow continuous end, a second hollow continuous end, interior wall mans interposed between the leaflet valve means and means which define the exterior wall of the long lasting prosthetic heart valve, the covering means comprising a perimetrically variable compliant ring of soft material means disposed between the two separated sewing rings adapted to be an annulus left by excision of a natural valve;

said first and second hollow continuous ends being radially outwardly everted in the plane of the bases of the cusps to form the securing means which comprise at least one sewing ring, each sewing ring thereby comprising only contiguous and continuous connection with the exterior wall means.

27. A long lasting, biocompatible prosthetic heart valve which is used as a replacement valve for a natural valve excised from a native orifice and is patently permissive to liquid flow in a first direction and non-regurgently occlusive to liquid flow in the opposite direction, said prosthetic heart valve comprising:

leaflet valve means comprising essentially non-thrombogenic biochemically inert material means, cusp means which comprise a plurality of cusps which are similar in shape, size, and function to cusps of a natural heart valve having compliant commissures at free edges superiorly disposed in the first direction form bases of said cusps, and stent attachment means comprising cusp supporting means which extend int eh first direction to provide an attachment surface about each commissure and retreat inferiorly therefrom about adjoining cusp lines to provide an attachment surface about each cusp base and to thereby provide a non-occlusive passageway for liquid flow from within each cusp to natural vessel pathways in the region of attachment of the valve within the native orifice;

stent means comprising flexible, cylindrical frame means which provide structural support for the leaflet valve means and means for enveloping covering the frame means, the covering means comprising essentially biochemically inert material means, central orifice means for snugly, insertably receiving and affixing the leaflet valve means within the stent means, and means for securing the long lasting prosthetic heart valve in the native orifice;

the flexible, cylindrical frame means being of substantially rectangular cross section and comprising base means alternately disposed between the seamlessly attached to means for providing support for the stent attachment means at the superiorly disposed position of the commissures, the base means substantially comprising arcs of a cylindrical band transversely disposed across a plane defined by the bases of the cusps and the support providing means comprising a pair of substantially symmetrical extending members which are seamlessly joined in the region of the attachment surface of each commissure and separated in the region adjoining the bases of the cusps thereby providing circumferential, deformable support in the plane of the bases of the cusps;

the covering means comprising at least one section of hollow cylindrical seamless material means which comprises a first hollow continuous end, a second hollow continuous end, interior wall means interposed between the leaflet valve means and means which define the exterior wall of the long lasting prosthetic heart valve, the covering means comprising perimetrically variable compliant ring of soft material means comprising non-expanded polytetrafluoroethylene disposed between the two separated sewing rings adapted to be placed in an annulus left by excision of a natural valve;

said first and second hollow continuous ends being radially outwardly everted in the plane of the bases of the cusps to form the securing means which comprise at least one sewing ring, each sewing ring thereby comprising only contiguous and continuous connection with the exterior wall means.

29. A long lasting, biocompatible prosthetic heart valve which is used as a replacement valve for a natural valve excised from a native orifice and is patently permissive to liquid flow in a first direction and non-regurgently occlusive to liquid flow in the opposite direction, said prosthetic heart valve comprising:

leaflet valve means comprising essentially non-thrombogenic biochemically inert material means, cusp means which comprise a plurality of cusps which are similar in shape, size, and function to cusps of a natural heart valve having compliant commissures at free edges superiorly disposed in the first direction from bases of said cusps, and stent attachment means comprising cusp supporting means which extend in the first direction to provide an attachment surface about each commissure and retreat inferiorly therefrom about adjoining cusp lines to provide an attachment surface about each cusp base and to thereby provide a non-occlusive passageway for liquid flow from within each cusp to natural vessel pathways in the region of attachment of the valve within the native orifice;

stent means comprising flexible, cylindrical frame means which provide structural support for the leaflet valve means and means for envelopingly covering the frame means, the covering means comprising essentially biochemically inert material means, central orifice means for snugly, insertably receiving and affixing the leaflet valve means within the stent means, and means for securing the long lasting prosthetic heart valve in the native orifice;

the flexible, cylindrical frame means being of substantially rectangular cross section and comprising base means alternately disposed between the seamlessly attached to means for providing support for the stent attachment means at the superiorly disposed position of the commissures, the base means substantially comprising arcs of a cylindrical band transversely disposed across a plane defined by the bases of the cusps and the support providing means comprising a pair of substantially symmetrical extending members which are seamlessly joined in the region of the attachment surface of each commissure and separated in the region adjoining the bases of the cusps thereby providing circumferential, deformable support in the plane of the bases of the cusps;

the covering means comprising at least one section of hollow cylindrical seamless material means which comprises a first hollow continuous end, a second hollow continuous end, interior wall means interposed between the leaflet valve means and means which define the exterior wall of the long lasting prosthetic heart valve, said covering means comprising means for covering the at least one sewing ring and for interfacing with tissue within the annulus from which a natural valve has been excised, the at least one sewing ring covering and interfacing means comprising at least one impregnated biochemical selected form a group consisting of antibiotics and anticoagulant medicants;

said first and second hollow continuous ends being radially outwardly everted in the plane of the bases of the cusps to form the securing means which comprise at least one sewing ring, each sewing ring thereby comprising only contiguous and continuous connection with the exterior wall means.