Membrane for use in sutured or sutureless surgical procedures
View Patent ↗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.
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.
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 μm.
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.
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.
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.