Three-layer vascular prostheses

• US 5,413,597 A
• Filed: 04/15/1993
• Issued: 05/09/1995
• Est. Priority Date: 12/29/1990
• Status: Expired due to Fees

• Current Assignee: Milan Krajicek
• Original Assignee: Milan Krajicek
• Inventors: Krajicek, Milan
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): BRITTINGHAM, DEBRA
• Application Number:
  US08/047,881
• Time in Patent Office: 754 Days
• Field of Search: 623/1, 623/11, 623/12, 600/36, 128/DIG. 8
• US Class Current: 623/1.47
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/062 Apparatus for the production of blood vessels made from natural tissue or with layers of living cells prostheses made from natural tissue or living cells A61L27/507
• CPC Class Codes: A61F 2002/30032 differing in absorbability or resorbability, i.e. in absorption or resorption time
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30217 hollow cones, e.g. tubular-like cones
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30971 Laminates, i.e. layered products
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/003 differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/24 Collagen
• CPC Class Codes: A61L 27/34 Macromolecular materials
• 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 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 : Porous materials, e.g. foams or sponges
• CPC Class Codes: B29C 48/09 : Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
• CPC Class Codes: B29C 48/33 : with parts rotatable relative to each other
• CPC Class Codes: C08L 27/18 : Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: C08L 67/00 : Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain of polyester-amides C08L77/12; of polyester-imides C08L79/08; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 89/06 : derived from leather or skin , e.g. gelatin
• CPC Class Codes: Y10S 128/08 : Collagen

Abstract

The invention relates to three-layer vascular prostheses comprising an internal layer 1, a middle layer 2 and an external layer 3 which is characterized in that the middle layer 2 is made from a physiologically non-resorbable, porous material, and the internal layer 1 and the external layer 3 are self-supporting and are made from a physiologically resorbable, fibrillar material, and are tanned. The internal layer 1 and the external layer 3 preferably consist of collagen, but have different resorbability. The middle layer 2 is preferably made from inert fibers, preferably synthetic fibers, by means of textile technology. The biologically resorbable layers preferably comprise chemically or physically bonded or incorporated pharmacologically active substances.

Claims

1. An implantable three-layer vascular prosthesis comprising:

a tanned, physically self-supporting, physiologically resorbable internal layer (1),

a physiologically non-resorbable, porous middle layer (2),

a tanned, physically self-supporting, physiologically resorbable external layer (3),

wherein the internal layer and the external layer are made from a biological material and the tanning of the internal layer is to a greater extent than the tanning of the external layer whereby the external layer is resorbed faster than the internal layer after implantation into an organism.

2. The prostheses according to claim 1, wherein said vascular prosthesis is tubular.

3. The prostheses according to claim 1, characterized in that the non-resorbable porous material of the middle layer (2) consists of synthetic fibres.

4. The prosthesis according to claim 1, characterized in that the internal layer (1), the middle layer (2) and the external layer (3) have the form of a truncated cone tube having one end with a narrower diameter than the other end, the end diameters of each of the tubes preferably differing by at least 20%.

5. The prostheses according to claim 1, characterized in that the middle layer (2) comprises a visible mark (4) parallel to the longitudinal axis.

6. The prosthesis according to claim 1, characterized in that at least one of the internal layer (1) and the external layer (3) consists of collagen.

7. The prosthesis according to claim 6 wherein said collagen is bovine collagen.

8. The prosthesis according to claim 1, characterized in that at least one of the following applies:

(a) the internal layer (1) is tanned to such an extent that its resorption is completed 2 to 3 months after implantation and (b) the external layer (3) is tanned to such an extent that its resorption is completed 3 to 6 weeks after implantation.

9. The prosthesis according to claim 1, characterized in that a pharmacologically active agent is present in at least one of the material of the internal layer (1) and the material of the external layer (3).

10. The prosthesis according to claim 9 wherein the pharmacologically active agent in the internal layer (1) is selected from the group consisting of heparin, acetylsalicylic acid and prostaglandin.

11. The prosthesis according to claim 9 wherein the pharmacologically active agent in the material of the external layer (3) is selected from the group consisting of fibronectin and antibiotics.

12. The prosthesis according to claim 9 wherein the pharmacologically active agent is chemically bonded to the material of the layer.

13. The prosthesis according to claim 9 wherein the pharmacologically active agent is physically bonded to the material of the layer.

14. The prosthesis according to claim 9 wherein the pharmacologically active agent is incorporated into the material layer.

15. The prosthesis according to claim 1, characterized in that at least one of the material of the internal layer (1) and the material of the external layer (3) further comprises an aqueous solution of glycerol in a concentration of 5 to 30% by mass.

16. The prosthesis according to claim 1, characterized in that it comprises a reinforcing spiral made of a solid, biologically inert liner provided at at least one of the following locations:

(a) between the middle layer (2) and the external layer (3), and (b) on the outer surface of the external layer (3).

17. The prosthesis according to claim 16 wherein the inert liner is made of a material seleced from the group consisting of polytetrafluoroethylene and polyester.

18. The prostheses according to claim 3, wherein the synthetic fibers are physiologically inert polyester fibers.

19. The prostheses according to claim 3, wherein the synthetic fibers form a porous fabric made by textile technology.

20. A method for manufacturing the prosthesis according to claim 25, comprising the following steps:

(A) Preparing a self-supporting internal layer (1) from a physiologically resorbable fibrillar material,

(B) tanning the internal layer (1) by means of a biologically acceptable tanning agent to reduce swelling capacity,

(C) providing a middle layer (2) by applying a layer of a physiologically non-resorbable, porous material onto the internal layer (1),

(D) providing an external layer (3) by applying a self-supporting layer of a physiologically resorbable fibrillar material onto the middle layer (2),

and

(E) tanning the external layer (3) by means of a biologically acceptable tanning agent to reduce swelling capacity.

21. The method according to claim 20, further comprising at least one of the following steps:

(F) incorporating into the material of the internal layer (1) before one of steps A, B and C a pharmacologically active agent selected from the group consisting heparin, acetylsalicylic acid and prostaglandin;

(G) incorporating into the material of the external layer (3) a pharmacologically active agent selected from the group consisting of fibronectin and antibiotics;

(H) using as the non-resorbable porous material a physiologically inert polyester selected from the group consisting of fibers, non-woven fabrics and textile webs;

(I) incorporating into the internal layer (1) an aqueous solution of glycerol in a concentration of five to thirty percent by mass;

(J) incorporating into the external layer (3) an aqueous solution of glycerol in a concentration of five to thirty percent by mass;

(K) providing between the middle layer (2) and the external layer (3) a reinforcing spiral made of a solid, biologically inert liner selected from the group consisting of polytetrafluoroethylene and polyester;

(L) providing on the outer surface of the external layer (3) a reinforcing spiral made of a solid, biologically inert liner selected from the group consisting of polytetrafluoroethylene and polyester;

(M) forming the internal layer (1), the middle layer (2) and the external layer (3) in the form of a truncated cone tube, each tube having an inner diameter differing from each other by at least 20 percent; and

(N) providing on the middle layer (2) a visible mark, parallel to the longitudinal axis of the prosthesis.

22. A method according to claim 20 wherein the tanning of the internal layer (1) takes place at a temperature of 50°

to 70°

C., and the tanning of the external layer (3) takes place at a temperature of 45°

to 58°

C.