Biomaterial based on aligned fibers, arranged in a gradient interface, with mechanical reinforcement for tracheal regeneration and repair

Abstract

An implant can include a plurality of polymeric fibers associated together into a fibrous body. The fibrous body is capable of being shaped to fit a tracheal defect and capable of being secured in place by suture or by bioadhesive. The fibrous body can have aligned fibers (e.g., circumferentially aligned) or unaligned fibers. The fibrous body can be electrospun. The fibrous body can have a first characteristic in a first gradient distribution across at least a portion of the fibrous body. The fibrous body can include one or more structural reinforcing members, such as ribbon structural reinforcing members, which can be embedded in the plurality of fibers. The fibrous body can include one or more structural reinforcing members bonded to the fibers with liquid polymer as an adhesive, the liquid polymer having a substantially similar composition of the fibers.

1 .- 62 . (canceled) 
     
     
         63 . A fibrous scaffold comprising:
 a first type of polymeric electrospun fiber; and   a second type of polymeric electrospun fiber;   wherein at least one of the first type of polymeric electrospun fiber and the second type of polymeric electrospun fiber comprise a polymer selected from the group consisting of polyglycolic acid, poly(lactic-co-glycolic acid), poly(L-lactide-co-caprolactone), and polycaprolactone; and   wherein the first type of polymeric electrospun fiber and the second type of polymeric electrospun fiber are co-electrospun.   
     
     
         64 . The fibrous scaffold of  claim 63 , wherein the first type of polymeric electrospun fiber comprises polyglycolic acid, and wherein the second type of polymeric electrospun fiber comprises poly(L-lactide-co-caprolactone). 
     
     
         65 . The fibrous scaffold of  claim 63 , wherein the first type of polymeric electrospun fiber comprises poly(lactic-co-glycolic acid), and wherein the second type of polymeric electrospun fiber comprises a biodegradable polymer. 
     
     
         66 . The fibrous scaffold of  claim 63 , wherein the first type of polymeric electrospun fiber comprises polycaprolactone, and wherein the second type of polymeric electrospun fiber comprises poly(lactic-co-glycolic acid). 
     
     
         67 . The fibrous scaffold of  claim 63 , wherein the first type of polymeric electrospun fiber and the second type of polymeric electrospun fiber are randomly oriented with respect to one another. 
     
     
         68 . The fibrous scaffold of  claim 63 , wherein the fibrous scaffold has a shape selected from the group consisting of a patch, a sheet, and a tube. 
     
     
         69 . The fibrous scaffold of  claim 63 , wherein the fibrous scaffold is configured for use with a wound. 
     
     
         70 . The fibrous scaffold of  claim 63 , wherein at least one of the first type of polymeric electrospun fiber and the second type of polymer electrospun fiber further comprise an active agent. 
     
     
         71 . The fibrous scaffold of  claim 70 , wherein the active agent is selected from the group consisting of an antimicrobial, a pharmaceutical, a tissue growth factor, a protein, a nanophase material, and combinations thereof. 
     
     
         72 . The fibrous scaffold of  claim 63 , wherein the first type of polymeric electrospun fiber comprises a first active agent, and wherein the second type of polymeric electrospun fiber comprises a second active agent different from the first active agent. 
     
     
         73 . The fibrous scaffold of  claim 63 , further comprising a plurality of live cells. 
     
     
         74 . A tubular fibrous scaffold having an inner surface and an outer surface, the tubular fibrous scaffold comprising:
 a first section and a second section, wherein the first second and the second section have a gradient interface;   wherein the first section comprises the inner surface, and wherein the second section comprises the outer surface; and   wherein the first section comprises a plurality of biodegradable polymeric electrospun fibers, and wherein the second section comprises a plurality of biostable polymeric electrospun fibers.   
     
     
         75 . The tubular fibrous scaffold of  claim 74 , wherein the plurality of biodegradable polymeric electrospun fibers comprise a first type of polymeric electrospun fiber and a second type of polymeric electrospun fiber. 
     
     
         76 . The tubular fibrous scaffold of  claim 75 , wherein the first type of polymeric electrospun fiber and the second type of polymeric electrospun fiber are co-electrospun, and wherein the first type of polymeric electrospun fiber and the second type of polymeric electrospun fiber are randomly oriented with respect to one another. 
     
     
         77 . The tubular fibrous scaffold of  claim 74 , wherein the plurality of biodegradable polymeric electrospun fibers comprise a third type of polymeric electrospun fiber and a fourth type of polymeric electrospun fiber. 
     
     
         78 . The tubular fibrous scaffold of  claim 77 , wherein the third type of polymeric electrospun fiber and the fourth type of polymeric electrospun fiber are co-electrospun, and wherein the third type of polymeric electrospun fiber and the fourth type of polymeric electrospun fiber are randomly oriented with respect to one another. 
     
     
         79 . The tubular fibrous scaffold of  claim 74 , wherein at least one of the plurality of biodegradable polymeric electrospun fibers and the plurality of biostable polymeric electrospun fibers further comprise an active agent. 
     
     
         80 . The tubular fibrous scaffold of  claim 79 , wherein the active agent is selected from the group consisting of an antimicrobial, a pharmaceutical, a tissue growth factor, a protein, a nanophase material, and combinations thereof. 
     
     
         81 . The tubular fibrous scaffold of  claim 74 , wherein the plurality of biodegradable polymeric electrospun fibers comprise a first active agent, and wherein the plurality of biostable polymeric electrospun fibers comprise a second active agent different from the first active agent.