A multi-layer collagen-based membrane that includes a bioresorbable mesh embedded between a first decellularized natural collagen-based membrane and a second decellularized natural collagen-based membrane. The bioresorbable mesh can be formed of a synthetic polymer or demineralized laminar bone. Als
A multi-layer collagen-based membrane that includes a bioresorbable mesh embedded between a first decellularized natural collagen-based membrane and a second decellularized natural collagen-based membrane. The bioresorbable mesh can be formed of a synthetic polymer or demineralized laminar bone. Also provided are two methods for manufacturing a multi-layer collagen-based membrane with or without an embedded bioresorbable mesh.
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1. A multi-layer collagen-based membrane, comprising a bioresorbable mesh embedded between a first decellularized natural collagen-based membrane and a second decellularized natural collagen-based membrane, wherein the first and second decellularized natural collagen-based membranes are cross-linked
1. A multi-layer collagen-based membrane, comprising a bioresorbable mesh embedded between a first decellularized natural collagen-based membrane and a second decellularized natural collagen-based membrane, wherein the first and second decellularized natural collagen-based membranes are cross-linked to each other and the multi-layer collagen-based membrane has a peel strength at 90° of 5-250 N/m. 2. The multi-layer collagen-based membrane of claim 1, wherein the bioresorbable mesh is formed of demineralized laminar bone. 3. The multi-layer collagen-based membrane of claim 1, wherein the bioresorbable mesh is a synthetic polymer mesh, wherein the synthetic polymer mesh bestows a shape memory on the multi-layer collagen-based membrane. 4. The multi-layer collagen-based membrane of claim 3, wherein the synthetic polymer mesh is formed of a homo-polymer or co-polymer that contains a polymer selected from the group consisting of polylactide (PLA), polyglycolide (PGA), polycaprolactone (PCL), trimethylene carbonate (PTMC), poly(lactic-co-glycolic acid) (PLGA), and poly(lactide-co-ε-caprolactone) (PLCL), or a mixture thereof. 5. The multi-layer collagen-based membrane of claim 4, wherein the synthetic polymer mesh is formed of PLGA having a lactic acid to glycolic acid monomer ratio of 25:75 to 75:25. 6. The multi-layer collagen-based membrane of claim 1, wherein the first decellularized natural collagen-containing membrane has a fibrous side and a serosal side and the second decellularized natural collagen-containing membrane also has a fibrous side and a serosal side. 7. The multi-layer collagen-based membrane of claim 6, wherein the fibrous side of the first decellularized natural collagen-containing membrane is in contact with and cross-linked to the fibrous side of the second decellularized natural collagen-containing membrane. 8. The multi-layer collagen-based membrane of claim 6, wherein the fibrous side of the first decellularized natural collagen-containing membrane is in contact with and cross-linked to the serosal side of the second decellularized natural collagen-containing membrane. 9. The multi-layer collagen-based membrane of claim 6, wherein the serosal side of the first decellularized natural collagen-containing membrane is in contact with and cross-linked to the serosal side of the second decellularized natural collagen-containing membrane. 10. A method for manufacturing a multi-layer collagen-based membrane, the method comprising: obtaining a first decellularized natural collagen-containing membrane;obtaining a second decellularized natural collagen-containing membrane;placing the second decellularized natural collagen-containing membrane atop the first decellularized natural collagen-containing membrane, thereby forming a membrane assembly;drying the membrane assembly under a weight distributed uniformly across the membrane assembly, the weight including openings for allowing moisture to escape; andexposing the membrane assembly to a cross-linking agent such that cross-links form between layers of the membrane assembly, thereby forming a multi-layer collagen-based membrane,wherein each of the layers of the multi-layer collagen-based membrane is resorbed at essentially the same rate upon implantation in vivo and no adhesives are employed in the process. 11. The method of claim 10, wherein the cross-linking agent is a chemical cross-linking agent or ultraviolet (UV) radiation. 12. The method of claim 11, wherein the cross-linking agent is UV radiation and the method further comprises a step of removing odorant compounds produced by the UV radiation and a step of drying the multi-layer collagen-based membrane. 13. The method of claim 12, wherein the exposing step is accomplished by irradiating a top side and a bottom side of the dried membrane assembly with UV radiation at an energy level of 1,200 to 216,000 mJ/m2. 14. The method of claim 13, wherein the top side and the bottom side of the dried membrane mesh assembly is irradiated for 1 to 210 minutes. 15. The method of claim 13, wherein the UV radiation has an energy level of 14,000 to 20,000 mJ/m2. 16. The method of claim 15, wherein the top side and the bottom side of the dried membrane mesh assembly is irradiated for 5 to 20 minutes. 17. The method of claim 10, wherein the first decellularized natural collagen-containing membrane is derived from a first natural pericardium membrane and has a fibrous side and a serosal side. 18. The method of claim 17, wherein the second decellularized natural collagen-containing membrane is derived from a second natural pericardium membrane and has a fibrous side and a serosal side. 19. The method of claim 18, wherein the fibrous side of the first decellularized natural collagen-containing membrane is placed in contact with the fibrous side of the second decellularized natural collagen-containing membrane. 20. The method of claim 18, wherein the serosal side of the first decellularized natural collagen-containing membrane is placed in contact with the fibrous side of the second decellularized natural collagen-containing membrane. 21. The method of claim 18, wherein the serosal side of the first decellularized natural collagen-containing membrane is placed in contact with the serosal side of the second decellularized natural collagen-containing membrane. 22. The method of claim 17, wherein the first natural pericardium membrane is porcine. 23. The method of claim 10, further comprising placing a bioresorbable mesh onto the first decellularized natural collagen-containing membrane before placing the second decellularized natural collagen-containing membrane atop the first decellularized natural collagen-containing membrane such that the bioresorbable mesh is sandwiched between the first decellularized natural collagen-containing membrane and the second decellularized natural collagen-containing membrane. 24. The method of claim 23, wherein the bioresorbable mesh is a synthetic polymer mesh formed of a homo-polymer or co-polymer that contains a polymer selected from the group consisting of polylactide (PLA), polyglycolide (PGA), polycaprolactone (PCL), trimethylene carbonate (PTMC), poly(lactic-co-glycolic acid) (PLGA), and poly(lactide-co-ε-caprolactone) (PLCL), or a mixture thereof and the synthetic polymer mesh affords a shape memory to the multi-layer collagen-based membrane. 25. The method of claim 24, wherein the synthetic polymer mesh is formed of PLGA having a lactic acid to glycolic acid monomer ratio of 25:75 to 75:25. 26. The method of claim 25, wherein the monomer ratio is 50:50. 27. The method of claim 23, wherein the bioresorbable mesh is formed of demineralized laminar bone. 28. A method for manufacturing a multi-layer collagen-based membrane, the method comprising: obtaining a first dried decellularized natural collagen-containing membrane;obtaining a bioresorbable synthetic polymer mesh, the mesh having a shape memory;placing the bioresorbable synthetic polymer mesh atop the first dried decellularized natural collagen-containing membrane;hydrating the first dried decellularized natural collagen-containing membrane to form a first hydrated membrane;obtaining a second dried decellularized natural collagen-containing membrane;placing the second dried decellularized natural collagen-containing membrane atop the bioresorbable synthetic polymer mesh such that the second dried decellularized natural collagen-containing membrane becomes hydrated by drawing moisture from the first hydrated membrane, thereby forming a membrane mesh assembly;drying the membrane mesh assembly under a weight distributed uniformly across the membrane mesh assembly, the weight including openings for allowing moisture to escape; andexposing the dried membrane mesh assembly to a cross-linking agent such that cross-links form between layers of the membrane mesh assembly, thereby forming a multi-layer collagen-based membrane,wherein each of the layers of the multi-layer collagen-based membrane is resorbed at essentially the same rate, the bioresorbable synthetic polymer mesh affords a shape memory to the multi-layer collagen-based membrane, and no adhesives are employed in the process. 29. The method of claim 28, wherein the cross-linking agent is a chemical cross-linker or UV radiation. 30. The method of claim 28, wherein the hydrating step is carried out by applying a collagen gel to the first dried decellularized natural collagen-containing membrane. 31. The method of claim 29, wherein the collagen gel has a concentration of 2 mg/mL to 10 mg/mL.
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