Membrane for use in sutured or sutureless surgical procedures

• US 20030204270A1
• Filed: 04/25/2002
• Published: 10/30/2003
• Est. Priority Date: 04/25/2002
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Enterprise Holdings Incorporated (W.L. Gore and Associates)
• Inventors: Wentworth, Dean R., Berman, Andrew B., Kranzler, Thane L.
• Granted Patent: US 7,641,958 B2
• Time in Patent Office: Days
• US Class Current: 623/23.64
• 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 polymer;

a second layer of TFE/PMVE copolymer thermoplastic elastomer;

wherein the first layer is 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.

9. A method of forming an implantable device comprising:

providing a laminate of a first polymer layer and a second elastomer layer;

treating the first polymer layer with a laser so as to cut fully through the first layer to expose the second layer.

10. The method of claim 9 further comprising cutting through the first layer to form a pattern of discontinuities.

11. The method of claim 10 further comprising cutting through the first layer to form a linear pattern of discontinuities.

12. The method of claim 10 further comprising cutting through the first layer to form a crosshatch pattern of discontinuities.

13. An implantable article comprising a first layer of multiple adjacent polymer structures joined to a second layer of elastomer;

wherein the adjacent polymer structures in the first layer are separated from each other by the elastomer.

14. The implantable article of claim 13 wherein the first layer comprises ePTFE.

15. An implantable sheet comprising:

a first polymer layer that is macroscopically rough;

a second elastomer layer attached to the first layer at least 0.2mm thick;

wherein the implantable sheet is resistant to suture hole leakage.

16. The implantable sheet of claim 15 wherein the sheet has an in vitro leak rate of less than about 50 ml/min.

17. The implantable sheet of claim 15 wherein the sheet has an in vitro leak rate of less than about 100 ml/min.

18. The implantable sheet of claim 15 wherein the sheet has an in vitro leak rate of less than about 200 ml/min.