Bioprosthetic conduits

• US 6,197,143 B1
• Filed: 10/26/1998
• Issued: 03/06/2001
• Est. Priority Date: 04/24/1996
• Status: Expired due to Fees

• Current Assignee: Endre Bodnar
• Original Assignee: Endre Bodnar
• Inventors: Bodnar, Endre
• Primary Examiner(s): Ball, Michael W.
• Assistant Examiner(s): Musser, Barbara J.
• Application Number:
  US09/178,860
• Time in Patent Office: 862 Days
• Field of Search: 623/2.13, 623/2.15, 623/2.16, 623/901, 623/910, 600/36, 156/218, 156/93
• US Class Current: 156/218
• CPC Class Codes: A61F 2/06 Blood vessels
• 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 2/2415 Manufacturing methods
• CPC Class Codes: B29C 33/48 with means for collapsing or disassembling
• CPC Class Codes: B29C 53/42 using internal forming surfaces, e.g. mandrels
• CPC Class Codes: B29C 67/0018 Turning tubes inside out for lining internal surfaces B29C63/36
• CPC Class Codes: B29L 2031/7534 Cardiovascular protheses
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device
• CPC Class Codes: Y10S 623/91 Heart
• CPC Class Codes: Y10T 156/1038 Hollow cylinder article

Abstract

A method of making a bioprosthetic conduit, comprises the steps of:

(a) taking a cylindrical mould, having circumferentially spaced protuberances which extend radially from the axis;

(b) curving a layer of a biocompatible sheet material around the cylindrical mould, and joining the opposed edges of the layer together along a longitudinal axis, parallel to the axis of the mould to form a tubular layer; and

(c) removing the tubular layer from the mould and turning it inside out to form a cylindrical conduit with sinuses, the conduit being fully fixed by a chemical means; after removal or while still on the mould. Where the conduit is required to be valved, in an additional step (d) an outer biocompatible layer is overlaid on the underlying tubular layer to form a superimposed layer, so that the superimposed layer partially covers the protuberances, the superimposed layer is held in place and sealed onto the underlying tubular layer around the protuberances, to form sinuses and cusps or valve flaps, the layers being partially fixed on the mould by a chemical means.

Claims

1. A method of making a bioprosthetic conduit, comprising the steps of:

(a) taking a cylindrical mould, having a longitudinal axis, and having circumferentially spaced protuberances which extend radially from said longitudinal axis;

(b) curving a layer of a biocompatible sheet material around the cylindrical mould, and joining the opposed edges of the layer together along a longitudinal axis, parallel to the longitudinal axis of the mould, to form a tubular layer having protuberances corresponding to those of the mould; and

(c) removing the tubular layer from the mould and turning it inside out to form a cylindrical conduit, the conduit having sinuses corresponding to the protuberances possessed by the tubular layer whilst still on the mould, and the conduit being fully fixed by a chemical means;

after removal or while still on the mould.

2. The method of claim 1, wherein the following additional step is carried out directly after step “

b”

;

(d) An outer biocompatible layer is curved over the underlying tubular layer to form a superimposed layer, so that the superimposed layer partially covers the protuberances, the superimposed layer is held in place and sealed onto the underlying tubular layer, to form sinuses and cusps or valve flaps, the layers being partially fixed on the mould by a chemical means.

3. The method of claim 2, wherein the additional step (d) is achieved by partially peeling back one end of the tubular layer along the mould, so that the peeled back end partially covers the protuberances, inserting an O-ring of supportive material into the fold, sealing together the superimposed end of the layer and the underlying tubular layer, to form cusps, or valve flaps, and sinuses, the layer being partially fixed on the mould by a chemical means.

4. The method of claim 2, wherein the outer biocompatible layer is a separate layer of biocompatible material, this layer being held in place on the underlying tubular layer and sealed onto the tubular layer.

5. The method of claim 1, wherein the biocompatible layer comprises a synthetic material.

6. The method of claim 1, wherein the tubular mould is radially collapsible.

7. The method of claim 1, wherein the mould is readily soluble.

8. The method of claim 1, wherein the edges of the layer are joined together, or layers sealed together, by a chemical means.

9. The method of claim 8, wherein the chemical means comprises an adhesive.

10. The method of claim 1, wherein the edges of the layer are joined together, or layers sealed together by heat.

11. The method of claim 1, wherein the edges of the layer are joined together, or layers sealed together, by sutures or staples.

12. The method of claim 2, wherein at least one biocompatible layer comprises a synthetic material.

13. The method of claim 2, wherein the tubular mould is radially collapsible.

14. The method of claim 2, wherein the mould is readily soluble.

15. The method of claim 2, wherein the edges of the layer are joined together, or layers sealed together, by a chemical means.

16. The method of claim 15, wherein the chemical means comprises an adhesive.

17. The method of claim 2, wherein the edges of the layer are joined together, or layers sealed together, by heat.

18. The method of claim 2, wherein the edges of the layer are joined together, or layers sealed together, by sutures or staples.

19. The method of claim 1, wherein the biocompatible layer comprises biological tissue.

20. The method of claim 2, wherein at least one biocompatible layer comprises biological tissue.

21. The method of claim 20, wherein the biological tissue is pericardium tissue.

22. The method of claim 19, wherein the biological tissue is pericardium tissue.