Process of manufacturing porous multi-expanded fluoropolymers

• US 5,071,609 A
• Filed: 11/03/1988
• Issued: 12/10/1991
• Est. Priority Date: 11/26/1986
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Baxter International Inc.
• Inventors: Roberts, Mark A., Tu, Roger H., Mathewson, Wilfred F.
• Primary Examiner(s): Theisen, Mary Lynn
• Application Number:
  US07/266,745
• Time in Patent Office: 1,132 Days
• Field of Search: 264/505, 264/567, 264/127, 264/154, 264/175, 264/235.6, 264/288.8, 264/289.3, 264/290.2, 264/290.5, 264/210.7, 264/119, 428/398, 428/422, 526/255
• US Class Current: 264/119
• CPC Class Codes: B29C 55/005 characterised by the choice of materials
• CPC Class Codes: B29K 2027/18 PTFE, i.e. polytetrafluorethene , e.g. ePTFE, i.e. expanded polytetrafluorethene
• CPC Class Codes: B29K 2105/0088 Blends of polymers
• CPC Class Codes: B29K 2105/04 cellular or porous
• CPC Class Codes: C08J 2327/18 Homopolymers or copolymers of tetrafluoroethylene
• CPC Class Codes: C08J 9/00 Working-up of macromolecular substances to porous or cellular articles or materials; After-treatment thereof mechanical aspects of shaping of plastics or substances in a plastic state for the production of porous or cellular articles B29C
• CPC Class Codes: C08L 21/00 Compositions of unspecified rubbers
• CPC Class Codes: C08L 2666/02 Organic macromolecular compounds, natural resins, waxes or and bituminous materials
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: Y10T 428/31544 Addition polymer is perhalogenated

Abstract

Interpenetrated matrix of polytetrafluoroethylene and elastomer is disclosed. The matrix is formed into a composite material which is flexible, durable, highly porous with a tight microporous structure and improved retractability. The composite material is subjected to a multi-expansion process to produce shaped articles such as films, tubes, rods and filaments with excellent flexibility and elasticity. More particularly, the composite material can be utilized to produce vascular grafts with excellent biological compatibility.

Claims

1. A process of preparing a polytetrafluroethylene-elastomer microporous substrate comprising the steps of:

forming said substrate from a blend of polytetrafluoroethylene and an elastomer;

heating said substrate to a temperature, and for a period of time which will not cause said elastomer to become cured;

expanding said heated substrate to a first expanded position;

maintaining said substrate in said first expanded position;

heating said substrate to a temperature for a sufficient period of time for curing said elastomer but that will not effect sintering of said polytetrafluoroethylene;

raising the temperature of said substrate for a sufficient period of time to flash sinter said polytetrafluoroethylene while allowing the substrate to assume a second expanded position.

2. The process of claim 1 wherein said substrate is allowed to assume said second expanded position by performing a second step of expanding said substrate between said step of curing and flash sintering.

3. The process of claim 2 further including a second step of maintaining said substrate in said second expanded position before said step of flash sintering is performed.

4. The process of claim 1 wherein said first step of heating is performed to uniformly heat said substrate to said temperature below said elastomer curing temperature.

5. The process of claim 1 further including a step of preparing said polytetrafluroethylene-elastomer blend, with said elastomer comprising from about ten to thirty weight percent of said blend.

6. The process of claim 3 further including a step of preparing said polytetrafluroethylene-elastomer blend, with said elastomer comprising from about ten to thirty weight percent of said blend.

7. A process of forming a vascular graft comprising the steps of:

forming a tubular structure from a blend of polytetrafluoroethylene and at least one elastomer;

heating said tubular structure to a temperature below said elastomer curing temperature;

expanding said tubular structure to a first expanded state;

maintaining said tubular structure in said first expanded state;

curing said elastomer;

and flash sintering said polytetrafluoroethylene while allowing said tubular structure to assume a second expanded position.

8. The process of claim 7 wherein said tubular structure is allowed to assume a second expanded position by releasing said tubular structure from said first expanded position prior to said sintering step.

9. The process of claim 7 wherein said tubular structure is allowed to assume a second expanded position by maintaining said tubular structure completely or partially in said first expanded position before said step of flash sintering is performed.

10. The process of claims 8 or 9 wherein said step of heating is performed to uniformly heat said tubular structure to said temperature below said elastomer curing temperature.

11. The process of claims 10 further including a step of preparing said polytetrafluroethylene-elastomer blend, with said elastomer comprising from about ten to thirty weight percent of said blend.

12. The process of claims 11 further including a step of preparing said polytetrafluroethylene-elastomer blend, with said elastomer comprising from about ten to thirty weight percent of said blend.

13. The process of claims 12 wherein said step of expanding of said tubular structure is performed by expanding said tubular structure in the longitudinal or radially direction, or both directions.

14. The process of claim 13 wherein said expanding step is performed to expand said tubular structure at a rate of about ten to about one-hundred percent per second and to a ratio of about two-hundred to about six-hundred percent of said tubular structure original length.

15. The process of claim 13 wherein said expanding step is performed to expand said tubular structure at a rate of about ten to about fifty percent per second and to a ratio of about two-hundred to about three-hundred percent of said tubular structure original length.

16. The process of claim 15 wherein said polytetrafluroethylene-elastomer blend is formed with from about ten to about thirty percent elastomer.

17. The process of claim 7 further including a second step of expanding said tubular structure between said step of curing and flash sintering.

18. The process of claim 17 wherein said tubular structure is released from said second expanded position prior to said sintering step.

19. The process of claim 17 wherein said tubular structure is completely or partially maintained in said second expanded position during said sintering step.

20. The process of claims 18 or 19 further including a step of preparing said polytetrafluroethylene-elastomer blend, with said elastomer comprising from about ten to thirty weight percent of said blend.

21. The process of claim 20 wherein said step of expanding of said tubular structure is performed by expanding said tubular structure in the longitudinal or radially direction, or both directions.

22. The process of claim 21 wherein said expanding step is performed to expand said tubular structure at a rate of about ten to about one-hundred percent per second and to a ratio of about two-hundred to about six-hundred percent of said tubular structure original length.

23. The process of claim 22 wherein said expanding step is performed to expand said tubular structure at a rate of about ten to about fifty percent per second and to a ratio of about two-hundred to about three-hundred percent of said tubular structure original length.