Cuffed tubular organic prostheses

• US 4,728,328 A
• Filed: 06/03/1985
• Issued: 03/01/1988
• Est. Priority Date: 10/19/1984
• Status: Expired due to Fees

• Current Assignee: Pennsylvania Research Corporation
• Original Assignee: Research Corporation
• Inventors: Kissinger, Jacob T., Hughes, Howard C.
• Primary Examiner(s): Apley, Richard J.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US06/740,358
• Time in Patent Office: 1,002 Days
• Field of Search: 623/1, 623/12, 623/11, 623/66, 128/334 R
• US Class Current: 623/23.69
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels

Abstract

A cuffed tubular vascular prosthesis and process for manufacturing the prosthesis are disclosed. A flexible tubular body is formed by coating a glass rod with a polymer solution and air-curing the coating to form a smooth outer surface. The tubular body is removed from the glass rod and turned inside out so that the smooth air cured surface forms the inner wall of the prosthesis. Prosthesis cuffs are formed on the distal ends of the prosthesis by folding the edges of the tubular body back over itself and bonding the turned back edges to the body. The prosthesis is heat set to maintain the cuffs in position during anastomosis. A double cuffed prosthesis is provided by sliding a suture sleeve over the prosthesis cuff, folding the sleeve back over itself and bonding to the prosthesis cuff and the tubular body. The prostheses provide an air-cured non thrombogenetic inner surface to prevent occlusion and efficient separation of the sutures from the lumen of the vessel or tubular organ being repaired to prevent tissue reactivity and thrombosis.

Claims

1. A cuffed tubular organic prosthesis for repairing or replacing tubular organs comprising:

a flexible tubular body having an inside diameter substantially equal to the inside diameter of an organ to be repaired or replaced; and

a prosthesis cuff on each distal end of said tubular body integral with said tubular body distal ends, each of said prosthesis cuffs having a rounded end for insertion within an open end of the organ and a free end bonded to said tubular body thereby forming a continuous smooth surface extending from the inner surface of the tubular body to the outer surface of the cuff, each of said prosthesis cuffs being adapted to be secured to the end of the tubular organ overlapping each distal end of said tubular body;

said tubular body and each of said prosthesis cuffs together forming a unitary, non-resorbable member adapted to extend permanently between open ends of a tubular organ.

2. The cuffed tubular organic prosthesis of claim 1 further including a pair of rigid rings embedded between each of said prosthesis cuffs and said tubular body.

3. The cuffed tubular organic prosthesis of claim 1 further including a pair of metal bands having a plurality of grooves, one each of said metal bands being embedded between each of said prosthesis cuffs and said tubular body.

4. The cuffed tubular organic prosthesis of claim 2 wherein said rigid rings are made of a biocompatible material.

5. The cuffed tubular organic prosthesis of claim 3 wherein said bands are made of a biocompatible material.

6. The cuffed tubular organic prosthesis of claim 4 wherein said biocompatible material is selected from the group consisting of platinum, titanium, nickel cobolt metal and stainless steel.

7. The cuffed tubular organic prosthesis of claim 5 wherein said biocompatible material is selected from the group consisting of platinum, titanium, a nickel cobolt metal and stainless steel.

8. The cuffed tubular organic prosthesis of claim 1 further including a suture cuff lying adjacent to each prosthesis cuff, each of said suture cuffs having a rounded end and a pair of cut ends, each rounded end of said suture cuffs facing the rounded end of the respective adjacent prosthesis cuff.

9. The cuffed tubular organic prosthesis of claim 8 wherein said suture cuffs circumferentially surround said tubular body and overlap the free end of said prosthesis cuffs.

10. The cuffed tubular organic prosthesis of claim 8 wherein said suture cuffs have two layers formed by folding one end of a sleeve adjacent to the other end of said sleeve.

11. The cuffed tubular organic prosthesis of claim 8 wherein said rounded end of each of said suture cuffs is bonded to the respective adjacent prosthesis cuff and wherein said cut ends of said suture cuffs are bonded to said tubular body.

12. The cuffed tubular organic prosthesis of claim 1 further including a soft polymer ring around said tubular body at the free end of said prosthesis cuff.

14. The cuffed tubular organic prosthesis of claim 1 or 8 or 13 wherein the tubular body is made of a segmented polyether polyurethane.

16. The cuffed tubular organic prosthesis of claim 1 further including support coils spirally wrapped around said flexible tubular body.

17. The cuffed tubular organic prosthesis of claim 8 further including support coils spirally wrapped around said flexible tubular body.

18. The cuffed tubular organic prosthesis of claim 16 further including a double layered suture cuff surrounding said tubular body and overlapping the free end of one of said prosthesis cuffs, and ligation means imbedded between the other of said prosthesis cuffs and said tubular body.

19. The cuffed tubular organic prosthesis of claim 16 wherein said tubular body is in the shape of a Y having first and second bifurcated sections and a main section.

20. The cuffed tubular organic prosthesis of claim 19 further including a double layered suture cuff surrounding the prosthesis cuff on the main section and ligation means imbedded within the prosthesis cuffs on each of the bifurcated sections.

21. The cuffed tubular organic prosthesis of claim 16 wherein said flexible tubular body includes a main section and a tapered section.

22. The cuffed tubular organic prosthesis of claim 21 further including a double layered suture cuff surrounding the prosthesis cuff of said main section, and ligation means imbedded within the prosthesis cuff of said tapered section.

23. The cuffed tubular organic prosthesis of claim 16 or 17 wherein said coils are made of wire coated with segmented polyether polyeurythane.

24. The cuffed tubular organic prosthesis of claim 16 or 17 or 18 or 20 further including a fiber sleeve wrapped circumferentially around the distal ends of said prosthesis.

25. The cuffed tubular organic prosthesis of claim 24 wherein said fibers are dacron or graphite.

26. The cuffed tubular organic prosthesis of claim 25 wherein said fabric is bonded to said tubular prosthesis.

13. A cuffed tubular organic prosthesis for repairing or replacing tubular organs comprising:

a flexible tubular body having a smooth air cured inner surface formed by coating a mandrel with a polymer solution, air curing said coating to form a smooth outer surface, removing the mandrel and turning said tubular body inside out so that said air cured smooth surface forms the inner wall of said tubular body, said tubular body having an inside diameter substantially equal to the inside diameter of an organ to be repaired or replaced; and

a prosthesis cuff on each distal end of said tubular body, each of said prosthesis cuffs having a continuous smooth air-cured surface extending from the inner surface of the tubular body to the outer surface of the cuff, said cuffs being formed by folding the edges of said tubular body back over said tubular body forming a rounded end for insertion within an open end of said organ and bonding said edges to said tubular body, each of said prosthesis cuffs being adapted to be secured to the end of the tubular organ overlapping each distal end of said tubular body;

said tubular body and each of said prosthesis cuffs together forming unitary, non-resorbable member adapted to extend perminantly between open ends of a tubular organ.

15. The double cuffed tubular organic prosthesis of claim 13 wherein said flexible tubular body has an inside diameter or 6 mm or less.