Synthetic implant device replicating natural tissue structure and methods of making same

Abstract

A composite implant device for use in a medical application, comprising a synthetically-derived mesh that mimics particular critical aspects of a biologically-derived mesh. The composite implant device can be used for the reinforcement and reconstruction of tissues within the body and can be comprised of a majority of synthetic components and minority of naturally-derived components which mimic the structure and function of a naturally-derived mesh.

What is claimed is: 
     
         1 . A multilayer construct, the construct comprising:
 a. a base layer comprising a synthetic polymer;   b. a first fibrous layer adjoined directly to the base layer;   c. a second fibrous layer adjoined directly to the first fibrous layer, 
wherein the first and second fibrous layers have non-identical properties. 
     
     
         2 . The construct of  claim 1  wherein the base layer is bioresorbable. 
     
     
         3 . The construct of  claim 1  wherein the base layer is in the form of a sheet and does not contain pores. 
     
     
         4 . The construct of  claim 1  wherein the base layer has a strain-at-break of 100-2500 %. 
     
     
         5 . The construct of  claim 1  wherein the base layer comprises a colorant. 
     
     
         6 . The construct of  claim 1  wherein the first layer comprises fibrous elements having a fiber diameter, wherein the fiber diameter is 0.001-1 mm. 
     
     
         7 . The construct of  claim 1  wherein the first layer comprises electrospun fibers. 
     
     
         8 . The construct of  claim 1  wherein the first layer is bioabsorbable. 
     
     
         9 . The construct of  claim 1  wherein the base layer is elastomeric and the first layer is elastomeric. 
     
     
         10 . The construct of  claim 1  wherein a deforming load of 100% strain-at-break does not cause delamination of the base layer from the first layer. 
     
     
         11 . The construct of  claim 1  wherein a copolyester is present in both the base layer and the first layer. 
     
     
         12 . The construct of  claim 1  wherein the second layer comprises fibrous elements having a fiber diameter, wherein the fiber diameter is 0.001-1 mm. 
     
     
         13 . The construct of  claim 1  wherein the second layer comprises electrospun fibers. 
     
     
         14 . The construct of  claim 1  wherein a copolyester is present in the base layer, the first layer and the second layer. 
     
     
         15 . The construct of  claim 1  wherein each of the base layer, the first layer and the second layer are bioabsorbable. 
     
     
         16 . A method for forming the multilayer construct of  claim 1 , the method comprising:
 a. providing a base layer comprising a synthetic polymer;   b. using an electrospinning technique to apply a solution comprising the synthetic polymer to the base layer, to provide the first fibrous layer which directly adjoins the base layer;   c. using an electrospinning technique to apply a solution comprising the synthetic polymer to the first fibrous layer, to provide the second fibrous layer which directly adjoins the first fibrous layer; 
 wherein the first and second fibrous layers have non-identical properties.