Surgical prosthesis

• US 20050244455A1
• Filed: 04/12/2005
• Published: 11/03/2005
• Est. Priority Date: 04/20/2004
• Status: Active Grant

• Current Assignee: Genzyme Corporation (Sanofi )
• Original Assignee: Genzyme Corporation (Sanofi )
• Inventors: Greenawalt, Keith E.
• Granted Patent: US 8,323,675 B2
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2250/003 differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/04 Macromolecular materials
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: C08L 23/10 Homopolymers or copolymers of propene
• CPC Class Codes: C08L 23/12 Polypropene
• CPC Class Codes: C08L 5/04 Alginic acid; Derivatives thereof
• CPC Class Codes: C08L 67/02 Polyesters derived from dicarboxylic acids and dihydroxy compounds C08L67/06 takes precedence
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

Surgical prostheses and methods of using and making surgical prostheses are disclosed.

Claims

1. A surgical prosthesis comprising:

a three-dimensional mesh comprising at least two types of yarn interlooped or intertwined to define at least two layers, wherein one of the at least two layers is substantially non-biodegradable and another of the at least two layers is substantially biodegradable; and

an adhesion barrier interconnected with the second, substantially biodegradable layer of the three-dimensional mesh.

2. The surgical prosthesis of claim 1, wherein one of the at least two types of yarn is non-biodegradable yarn.

3. The surgical prosthesis of claim 2, wherein the non-biodegradable yarn is selected from polypropylene, polyethylene terephthalate or a combination thereof.

4. The surgical prosthesis of claim 2, wherein the non-biodegradable yarn has a diameter of about 0.005 inches.

5. The surgical prosthesis of claim 1, wherein one of the at least two types of yarn is biodegradable yarn.

6. The surgical prosthesis of claim 5, wherein the biodegradable yarn is selected from poly (glycolic) acid, polylactic acid, polydioxanone, polycaprolactone, calcium alginate or a combination thereof.

7. The surgical prosthesis of claim 5, wherein the biodegradable yarn has a diameter no greater than about 90 denier.

8. The surgical prosthesis of claim 1, wherein the three-dimensional mesh includes at least one non-biodegradable monofilament yarn and at least one biodegradable multifilament yarn.

9. The surgical prosthesis of claim 1, wherein the adhesion barrier comprises a crosslinked polymer hydrogel.

10. The surgical prosthesis of claim 1, wherein the adhesion barrier comprises at least one polyanionic polysaccharide modified by reaction with carbodiimide.

11. The surgical prosthesis of claim 1, wherein the adhesion barrier comprises a crosslinked polymer hydrogel and at least one polyanionic polysaccharide modified by reaction with carbodiimide.

12. The surgical prosthesis of claim 11, wherein the crosslinked polymer hydrogel comprises one or more hydrophilic blocks, one or more biodegradable blocks, and one or more crosslinking blocks.

13. The surgical prosthesis of claim 11, wherein the crosslinked polymer hydrogel is formed by photopolymerization of monomers comprising photopolymerizable poly(ethylene glycol)-trimethylene carbonate/lactate multi-block polymer endcapped with acrylate esters.

14. The surgical prosthesis of claim 11, wherein the at least one polyanionic polysaccharide modified by reaction with carbodiimide comprises carbodiimide-modified hyaluronic acid and carbodiimide-modified carboxymethylcellulose.

15. The surgical prosthesis of claim 1, wherein the adhesion barrier is in the form of a film or foam.

16. The surgical prosthesis of claim 1, wherein the adhesion barrier is in the form of a gel.

17. The surgical prosthesis of claim 1, wherein the surgical prosthesis has a moisture content of less than about 2%.

18. The surgical prosthesis of claim 1, wherein the surgical prosthesis has a moisture content of less than about 1.2%.

19. The surgical prosthesis of claim 1, wherein the adhesion barrier has a density of about 5 grams total polymer per square foot.

49. A method of repairing an opening in a wall en closing a body cavity of a patient, the method comprising:

providing a surgical prosthesis of claim 1;

and

securing the surgical prosthesis over the wall opening of the patient such that the adhesion barrier faces viscera or tissue from which adhesion is to be prevented.

20. A surgical prosthesis comprising:

a first layer formed substantially of a non-biodegradable yarn, the first layer defining a first outer surface of the surgical prosthesis;

a second layer formed substantially of a first biodegradable yarn, the second layer connected to the first layer with a second biodegradable yarn; and

an adhesion barrier embedded within the second layer, the adhesion barrier defining a second outer surface of the surgical prosthesis,

wherein the first outer surface of the surgical prosthesis has a macroporous structure adapted to permit tissue ingrowth into the first layer and the second outer surface of the surgical prosthesis is adapted to minimize the formation of adhesion of tissue adjacent to the second outer surface.

21. The surgical prosthesis of claim 20, wherein the second outer surface of the surgical prosthesis is microporous.

22. The surgical prosthesis of claim 20, wherein the macroporous structure has a pore size of about 100 microns or more.

23. The surgical prosthesis of claim 20, wherein the non-biodegradable yarn is selected from polypropylene, polyethylene terephthalate or a combination thereof.

24. The surgical prosthesis of claim 20, wherein the first biodegradable yarn is selected from poly (glycolic) acid, polylactic acid, polydioxanone, polycaprolactone, calcium alginate or a combination thereof.

25. The surgical prosthesis of claim 20 wherein the second biodegradable yarn is selected from poly (glycolic) acid, polylactic acid, polydioxanone, polycaprolactone, calcium alginate or a combination thereof.

26. The surgical prosthesis of claim 20, wherein the barrier comprises a crosslinked polymer hydrogel and at least one polyanionic polysaccharide modified by reaction with carbodiimide.

27. The surgical prosthesis of claim 26, wherein the crosslinked polymer hydrogel comprises one or more hydrophilic blocks, one or more biodegradable blocks, and one or more crosslinking blocks.

28. The surgical prosthesis of claim 26, wherein the crosslinked polymer hydrogel is formed by polymerization of monomers comprising photopolymerizable poly(ethylene glycol)-trimethlyene carbonate/lactate multi-block polymers endcapped with acrylate esters.

29. The surgical prosthesis of claim 26, wherein the at least one polyanionic polysaccharide modified by reaction with carbodiimide comprises carbodiimide-modified hyaluronic acid and carbodiimide-modified carboxymethylcellulose.

30. A method of making a surgical prosthesis, the method comprising the steps of:

providing a fabric comprising a first layer formed substantially of non-biodegradable yarn and a second layer formed of biodegradable yarn;

providing a liquid formulation comprising macromers and an initiator;

placing the fabric within the liquid formulation such that the second layer is in fluid contact with the liquid formulation; and

exposing the liquid formulation to a light source.

31. The method of claim 30, wherein the initiator is a photoinitiator.

32. The method of claim 31, wherein the photoinitiator comprises Eosin Y.

33. The method of claim 30, wherein the liquid formulation further comprises biopolymers, an accelerant and a buffer.

34. The method of claim 33, wherein the biopolymers comprise at least one polyanionic polysaccharide modified by reaction with carbodiimide.

35. The method of claim 33, wherein the buffer comprises triethanolamine.

36. The method of claim 33, wherein the buffer comprises potassium phosphate.

37. The method of claim 33, wherein the accelerant comprises N-vinylcaprolactam.

38. The method of claim 30, wherein the liquid formulation comprises 1 weight percent of carbodiimide-modified hyaluronic acid and carboxymethylcellulose, 2.5 weight percent poly(ethylene glycol)-trimethlyene carbonate/lactate multi-block polymers endcapped with acrylate esters, 40 ppm of Eosin Y, 4000 ppm N-vinylcaprolactam, 0.54 weight percent triethanolamine, 0.8 weight percent of potassium phosphate.

39. The method of claim 30, wherein the light source is an LED array having an intensity of about 1 to about 100 mW/cm².

40. A method of making a surgical prosthesis, the method comprising the steps of:

providing a fabric comprising a first layer formed substantially of non-biodegradable yarn and a second layer formed of biodegradable yarn;

providing a liquid formulation comprising a first polymer system, a second polymer system, and a photoinitiator;

placing the fabric over the liquid formulation such that the second layer is in fluid contact with the liquid formulation; and

exposing the liquid formulation to a light source to activate the photoinitiator so as to cause polymerization of at least one of the polymer systems in the liquid formulation.

41. The method of claim 40, wherein the polymerization of at least one of the polymer systems results in the formation of a barrier layer partially embedded within the second layer of the fabric.

42. The method of claim 41, wherein the first polymer system comprises carbodiimide-modified hyaluronic acid and carbodiimide-modified carboxymethylcellulose and the second polymer system comprises poly(ethylene glycol)-trimethylene carbonate/lactate multi-block polymers endcapped with acrylate esters.

43. The method of claim 42, wherein the photoinitiator comprises Eosin Y.

44. The method of claim 43, wherein the liquid formulation further comprises an accelerant and at least one buffer.

45. The method of claim 44, wherein the liquid formulation further comprises a first buffer and a second buffer.

46. The method of claim 45, wherein the accelerant comprises N-vinylcaprolactam, the first buffer comprises triethanolamine, and the second buffer comprises potassium phosphate.

47. The method of claim 40, wherein the light source is an LED array having an intensity of about 1 to about 100 mW/cm².

48. The method of claim 41, further comprising the step of:

drying the fabric and the barrier layer in a convection oven.