MEMBRANE FOR USE IN SUTURED OR SUTURELESS SURGICAL PROCEDURES

• US 20100106258A1
• Filed: 11/24/2009
• Published: 04/29/2010
• Est. Priority Date: 04/25/2002
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Andrew B. Berman, Dean R. Wentworth, Thane L. Kranzler
• Inventors: Kranzler, Thane L., Wentworth, Dean R., Berman, Andrew B.
• Granted Patent: US 7,985,263 B2
• Time in Patent Office: Days
• US Class Current: 623/23.740
• 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 of bone tissue onto implantable joints A61F2002/3093
• CPC Class Codes: A61F 2002/009 for hindering or preventing attachment of biological tissue of bone tissue onto implantable joints A61F2002/30932
• 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. A surgically implantable article, comprising:

a first layer of multiple adjacent non-bioabsorbable polymer structures formed from a continuous non-bioabsorable 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.

2. The surgically implantable article of claim 1, wherein the first layer has a pattern of discontinuities.

3. The surgically implantable article of claim 2, wherein the pattern of discontinuities is a linear pattern.

4. The surgically implantable article of claim 2, wherein the pattern of discontinuities is a crosshatch pattern.

5. The surgically implantable article of claim 1, wherein the first layer is macroscopically rough.

6. The surgically implantable article of claim 1, wherein the article self seals when sutured.

7. The surgically implantable article of claim 1, wherein the article is resistant to suture hole leakage.

8. The surgically implantable article of claim of claim 1, wherein the first discontinuous layer comprises ePTFE.

9. The surgically implantable article of claim 1, wherein the article comprises a third layer of a polymer.

10. The surgically implantable article of claim 9, wherein the third layer substantially prevents tissue in-growth.

11. The surgically implantable article of claim 10, wherein said third layer comprises ePTFE having an average fibril length of less than about 5 μ

m.

12. The surgically implantable article of claim 1, wherein the first discontinuous layer allows for tissue in-growth.

13. A dura mater substitute, comprising:

a first layer of multiple adjacent non-bioabsorbable polymer structures formed from a continuous non-bioabsorable polymer layer that allows for native dura mater in-growth;

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

a third layer that substantially prevents tissue in-growth.

14. The dura mater substitute of claim 13, wherein the first layer has a pattern of discontinuities.

15. The dura mater substitute of claim 14, wherein the pattern of discontinuities is a linear pattern.

16. The dura mater substitute of claim 14, wherein the pattern of discontinuities is a crosshatch pattern.

17. The dura mater substitute of claim 13, wherein the first layer is macroscopically rough.

18. The dura mater substitute of claim 13, wherein said dura mater substitute is resistant to suture hole leakage.

19. The dura mater substitute of claim 13, wherein the first discontinuous layer comprises ePTFE.

20. The dura mater substitute of claim 13, wherein said third layer comprises ePTFE having an average fibril length of less than about 5 μ

m.