Longitudinally compliant vascular graft

• US 4,955,899 A
• Filed: 05/26/1989
• Issued: 09/11/1990
• Est. Priority Date: 05/26/1989
• Status: Expired due to Fees

• Current Assignee: IMPRA Incorporated (Becton, Dickinson & Co)
• Original Assignee: IMPRA Incorporated (Becton, Dickinson & Co)
• Inventors: Farnan, Robert C., Kowligi, Rajagopal R., Colone, William M., Della Corna, Linda V.
• Primary Examiner(s): Frinks, Ronald
• Application Number:
  US07/358,787
• Time in Patent Office: 473 Days
• Field of Search: 623/1, 623/11, 623/12, 623/901, 427/2
• US Class Current: 623/1.46
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• 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 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: B29D 23/001 Pipes; Pipe joints pleated hoses B29D23/18
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: C08L 75/04 Polyurethanes
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

A longitudinally compliant PTFE graft is provided by compressing at least a portion of a porous PTFE tube along its longitudinal axis and coating at least the outer wall of the compressed portion of the PTFE tube with a biocompatible elastomer for allowing the compressed portion of the tube to be stretched along the longitudinal axis. The PTFE tube is compressed by pulling the tube over a cylindrical mandrel of like diameter and applying a compression force to the tube along its longitudinal axis. The compressed portion(s) is (are) secured against movement upon the mandrel, and a coating of liquified polyurethane or other biocompatible elastomer is then applied over at least the compressed portion(s) of the tube. The elastomeric coating may be applied by dip coating or spray coating techniques. After the elastomeric coating has dried, the completed graft is removed from the mandrel.

Claims

1. A longitudinally compliant vascular graft comprising in combination:

a. a length of porous PTFE tubing having a micro-structure characterized by nodes interconnected by fibrils, said PTFE tubing having a central longitudinal axis and including an outer cylindrical wall, at least a portion of said PTFE tubing having been compressed along the central longitudinal axis thereof following the production of said PTFE tubing; and

b. a coating of a biocompatible elastomer covering the outer cylindrical wall of said PTFE tubing over at least said compressed portion of said PTFE tubing;

c. said compressed portion of said PTFE tubing coated by said biocompatible elastomer being adapted to be stretched along the central longitudinal axis of said PTFE tubing.

2. A longitudinally compliant graft as recited by claim 1 wherein said coating of a biocompatible elastomer is a polyurethane coating.

3. A longitudinally compliant graft as recited by claim 1 wherein said biocompatible elastomer is selected from the group of elastomers consisting of medical-grade silicone rubber elastomers, segmented polyurethanes, polyurethane-ureas, and silicone-polyurethane copolymers.

4. A longitudinally compliant graft as recited by claim 1 wherein said coating of a biocompatible elastomer is a non-porous coating.

5. A method of producing a longitudinally compliant PTFE vascular graft which is adapted to be stretched along its longitudinal axis, said method comprising the steps of:

a. providing a porous PTFE tube having a predetermined internal diameter and having a longitudinal axis, and including an outer cylindrical wall;

b. compressing at least a portion of the tube along its longitudinal axis while maintaining the predetermined internal diameter of the tube substantially constant;

c. applying a coating of a liquified elastomer to the outer cylindrical wall of the tube over at least the compressed portion thereof; and

d. drying the coating of liquified elastomer upon the outer cylindrical Wall of the tube while maintaining the compressed portion of the tube in a compressed condition.

6. The method recited by claim 5 Wherein said compressing step includes the steps of:

a. pulling the PTFE tube over a cylindrical mandrel having an outer diameter of approximately the same dimension as the internal diameter of the PTFE tube; and

b. compressing at least a portion of the PTFE tube along the longitudinal axis of the tube while the tube is supported by the mandrel.

7. The method recited by claim 6 wherein said coating step includes the step of dicoating at least the compressed portion of the PTFE tube into a container of the liquified elastomer while said PTFE tube is supported upon the mandrel.

8. The method recited by claim 6 wherein said coating step includes the step of spraying the liquified elastomer upon the outer cylindrical wall of the PTFE tube over at least the compressed portion of the PTFE tube while the PTFE tube is supported upon the mandrel.

9. The method recited by claim 5 wherein the elastomer is selected from the group of elastomers consisting of medical-grade silicone rubber elastomers, segmented polyurethanes, polyurethane-ureas, and silicone-polyurethane copolymers.

10. The method recited by claim 5 wherein the PTFE tube has first and second end portions, and wherein said compressing step compresses only the first and second end portions of the PTFE tube without compressing the central portion thereof extending between the first and second end portions.

11. The method recited by claim 10 wherein said coating step includes the step of applying a coating of the liquified elastomer to the entire outer cylindrical wall of the PTFE tube.

12. The method recited by claim 5 wherein said compressing step includes the step of compressing the PTFE tube uniformly along its entire length, and wherein said coating step includes the step of applying the liquified elastomer over the entire outer cylindrical Wall of the PTFE tube.

13. A longitudinally compliant vascular graft resulting from using the method comprising the steps of:

a. providing a porous PTFE tube having a predetermined internal diameter and having a longitudinal axis, and including an outer cylindrical wall;

b. compressing at least a portion of the tube along its longitudinal axis While maintaining the predetermined internal diameter of the tube substantially constant;

c. applying a coating of a liquified elastomer to the outer cylindrical wall of the tube over at least the compressed portion thereof; and

d. drying the coating of liquified elastomer upon the outer cylindrical Wall of the tube while maintaining the compressed portion of the tube in a compressed condition.

14. The longitudinally compliant vascular graft recited by claim 13, wherein the compressing step of the method used to produce such graft includes:

a. pulling the FTFE tube over a cylindrical mandrel having an outer diameter of approximately the same dimension as the internal diameter of the PTFE tube; and

b. compressing at least a portion of the PTFE tube along the longitudinal axis of the tube while the tube is supported by the mandrel.

15. The longitudinally compliant vascular graft recited by claim 14, wherein the coating step of the method used to produce such graft includes the step of dip coating at least the compressed portion of the PTFE tube into a container of the liquified elastomer while said PTFE tube is supported upon the mandrel.

16. The longitudinally compliant vascular graft recited by claim 14, wherein the coating step of the method used to produce such graft includes the step of spraying the liquified elastomer upon the outer cylindrical wall of the PTFE tube over at least the compressed portion of the PTFE tube while the PTFE tube is supported upon the mandrel.

17. The longitudinally compliant vascular graft recited by claim 14, wherein said elastomer is selected from the group of the elastomers consisting of medical-grade silicone rubber elastomers, segmented polyurethanes, polyurethane-ureas, and silicone-polyurethane copolymers.

18. The longitudinally compliant vascular graft recited by claim 13 wherein the PTFE tube has first and second opposing end portions and a central portion lying there between, and wherein the compressing step of the method used to produce such vascular graft includes the step of compressing only the first and second end portions of the PTFE tube without compressing the central portion thereof extending between the first and second end portions.

19. The longitudinally compliant vascular graft recited by claim 18 Wherein the coating step of the method used to produce such vascular graft includes the step of applying a coating of the liquified elastomer to the entire outer cylindrical wall of the PTFE tube.