Membrane for use in sutured or sutureless surgical procedures

• US 7,641,958 B2
• Filed: 04/25/2002
• Issued: 01/05/2010
• Est. Priority Date: 04/25/2002
• Status: Expired due to Fees

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Enterprise Holdings Incorporated (W.L. Gore and Associates)
• Inventors: Kranzer, Thane L., Wentworth, Dean R., Berman, Andrew B.
• Primary Examiner(s): Watkins, III; William P
• Application Number:
  US10/133,653
• Publication Number:
  US 20030204270A1
• Time in Patent Office: 2,812 Days
• Field of Search: 428/141, 428/156, 428/143, 428/147, 623/23.74, 623/23.76, 623/23.73, 623/23.72
• US Class Current: 428/143
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2002/0081 directly machined on the prosthetic surface, e.g. holes, grooves A61F2/30771 takes precedence
• CPC Class Codes: A61F 2002/0086 for preferentially controlling or promoting the growth of specific types of cells or tissues
• CPC Class Codes: A61F 2002/009 for hindering or preventing attachment of biological tissue
• CPC Class Codes: A61L 17/04 Non-resorbable materials
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: Y10T 428/24355 Continuous and nonuniform or irregular surface on layer or component [e.g., roofing, etc.]
• CPC Class Codes: Y10T 428/24372 Particulate matter
• CPC Class Codes: Y10T 428/24405 Polymer or resin [e.g., natural or synthetic rubber, etc.]
• CPC Class Codes: Y10T 428/24479 including variation in thickness
• CPC Class Codes: Y10T 428/249979 Specified thickness of void-containing component [absolute or relative] or numerical cell dimension
• CPC Class Codes: Y10T 428/31544 Addition polymer is perhalogenated

Abstract

An improved, polymeric surgical membrane, which can be used in a variety of surgical procedures, such as sutured and sutureless duraplasty procedures. For sutureless applications, a textured, discontinuous, outer polymer layer is provided which encourages rapid incorporation and anchoring into surrounding tissue. In cooperation with the discontinuous first layer, a second elastomeric layer provides elasticity and resilience. A third barrier layer is provided to essentially eliminate adhesions and irritation to surrounding tissue. In those applications requiring anchoring sutures, the second elastomeric layer “self-seals” against the sutures, essentially eliminating the leakage of blood, cerebrospinal fluid, or other fluids. In addition, the composite structure of the present invention has a high degree of suture retention strength is polymeric with a high degree of biocompatibility, is thin and very flexible.

Claims

1. An article comprising:

a first layer of non-bioabsorbable polymer; and

a second layer of TFE/PMVE copolymer thermoplastic elastomer,

wherein the first layer is macroscopically discontinuous and the second layer is continuous.

2. The article of claim 1, further comprising a third layer of a polymer.

3. The article of claim 1, wherein the first layer has a pattern of discontinuities.

4. The article of claim 3, wherein the pattern of discontinuities is a linear pattern.

5. The article of claim 3, wherein the pattern of discontinuities is a crosshatch pattern.

6. The article of claim 1, wherein the first layer comprises ePTFE.

7. The article of claim 1, wherein the article is an implantable device.

8. The implantable device of claim 7, wherein the device is a dura substitute.

20. The implantable device of claim 7, wherein the device is resistant to suture hole leakage.

21. The implantable device of claim 20, wherein the device has an in vitro leak rate of less than about 50 ml/mm.

9. An implantable sheet, comprising:

a first macroscopically discontinuous non-bioabsorbable polymer layer having a substantially linear pattern of discontinuities;

a second elastomer layer attached to the first layer; and

a third ePTFE layer having an average fibril length of less than about 5 μ

m.

10. The implantable sheet of claim 9, wherein the sheet has an in vitro leak rate of less than about 50 ml/min.

11. The implantable sheet of claim 9, wherein the sheet has an in vitro leak rate of less than about 100 ml/min.

12. The implantable sheet of claim 9, wherein the sheet has an in vitro leak rate of less than about 200 ml/min.

13. The implantable sheet of claim 9, wherein the elastomer layer comprises a TFE/PMVE copolymer.

14. The implantable sheet of claim 9, wherein the first discontinuous polymer layer has a pattern of discontinuities.

15. The implantable sheet of claim 14, wherein the pattern of discontinuities is a linear pattern.

16. The implantable sheet of claim 14, wherein the pattern of discontinuities is a crosshatch pattern.

17. The implantable sheet of claim 9, wherein the first discontinuous polymer layer comprises ePTFE.

18. The implantable sheet of claim 9, wherein the first discontinuous polymer layer is macroscopically rough.

19. The implantable sheet of claim 9, wherein the article is a dura substitute.

22. A surgically implantable article, comprising:

a first layer of multiple adjacent non-bioabsorbable structures formed from a continuous ePTFE polymer layer; and

a second layer of elastomer arranged on the first layer,

wherein the adjacent non-bioabsorbable polymer structures in the first layer are macroscopically discontinuous, being separated from each other by the elastomer.

23. A surgically implantable article, comprising:

a first layer of multiple adjacent non-bioabsorbable polymer structures formed from a continuous non-bioabsorbable polymer layer; and

a second layer of elastomer TFE/PMVE copolymer arranged on the first layer,

wherein the adjacent non-bioabsorbable polymer structures in the first layer are macroscopically discontinuous, being separated from each other by the elastomer.

24. A surgically implantable article, comprising:

a first layer of multiple adjacent non-bioabsorbable structures formed from a continuous ePTFE layer; and

a second layer of elastomer arranged on the first layer,

wherein the adjacent non-bioabsorbable polymer structures in the first layer comprises a macroscopically discontinuous pattern, being separated from each other by the elastomer.

25. A surgically implantable article, comprising:

a first layer of multiple adjacent non-bioabsorbable polymer structures formed from a continuous non-bioabsorbable polymer layer; and

a second layer of elastomer arranged on the first layer,

wherein the adjacent non-bioabsorbable polymer structures in the first layer are macroscopically discontinuous, being separated from each other by the elastomer and wherein the article is a dura substitute.