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. 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 polymer comprises ePTFE, said ePTFE having an average fibril length of less than about 5 μm.
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, said ePTFE having an average fibril length of less than about 5 μm.