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 . An implant comprising:
 a plurality of elongate polymeric fibers associated together into a fibrous body, the fibrous body having the plurality of polymeric fibers being molded, bound, wound, or electrospun together to form the fibrous body.   
     
     
         2 . (canceled) 
     
     
         3 . The implant of  claim 1 , the fibrous body having aligned fibers. 
     
     
         4 . The implant of  claim 1 , the fibrous body having unaligned fibers. 
     
     
         5 . The implant of  claim 3 , the fibrous body having circumferentially aligned fibers. 
     
     
         6 . (canceled) 
     
     
         7 . The implant of  claim 1 , the fibrous body having a first characteristic in a first gradient distribution across at least a portion of the fibrous body. 
     
     
         8 .- 11 . (canceled) 
     
     
         12 . The implant of  claim 1 , wherein the fibrous body includes one or more structural reinforcing members located within the fibrous body and encapsulated by the plurality of polymeric fibers. 
     
     
         13 . (canceled) 
     
     
         14 . The implant of  claim 12 , wherein the structural reinforcing members includes one or more circumferential structural reinforcing members embedded in the fibrous body with an annular shape or portion thereof. 
     
     
         15 .- 16 . (canceled) 
     
     
         17 . The implant of  claim 12 , wherein the one or more structural reinforcing members include bioglass. 
     
     
         18 . The implant of  claim 1 , wherein the fibrous body includes two or more different fiber types with different characteristics, wherein the different fiber types are distributed in two or more gradient distributions. 
     
     
         19 .- 21 . (canceled) 
     
     
         22 . The implant of  claim 18 , wherein different fibers of have different characteristics selected from type of composition; type of polymer; fiber diameter size; fiber diameter size distribution; type of bioactive agent in a fiber; type of bioactive agent combination in a fiber; bioactive agent concentration in a fiber; amount of bioactive agent in a fiber; rate of bioactive agent release from a fiber; mechanical strength of a fiber; flexibility of a fiber; rigidity of a fiber; color of a fiber; radiotranslucency of a fiber; or radiopaqueness of a fiber. 
     
     
         23 .- 26 . (canceled) 
     
     
         27 . The implant of  claim 1 , wherein the fibrous body has a plurality of distinct fiber layers of different types of fibers from one side or end to another side or end. 
     
     
         28 .- 30 . (canceled) 
     
     
         31 . The implant of  claim 1 , wherein the fibrous body is a wound fibrous body having:
 fibers of a first type at one or more inner layers of the wound fibrous body;   fibers of a second type intermingled with the one or more inner layers of the fibers of the first type adjacent to the one or more inner layers;   fibers of the second type at one or more second layers of the wound fibrous body adjacent to the intermingled fibers.   
     
     
         32 . The implant of  claim 1 , wherein the fibrous body a wound fibrous body having in order from one side:
 fibers of a first type at one or more inner layers of the wound fibrous body;   fibers of a second type intermingled with the one or more inner layers of the fibers of the first type;   fibers of the second type at one or more second layers of the wound fibrous body;   fibers of a third type or the first type intermingled with one or more second layers of the fibers of the second type; and   fibers of the third type at one or more third layers of the wound fibrous body.   
     
     
         33 .- 42 . (canceled) 
     
     
         43 . The implant of  claim 1 , wherein the fibrous body has different types of fibers arranged so as to mimic collagen arrangement in native tracheal cartilage, where outer superficial zones of the implant mimic cartilage and has circumferentially aligned fibers that mimic collagen fibers. 
     
     
         44 .- 55 . (canceled) 
     
     
         56 . A method of treating a tracheal defect, the method comprising:
 providing an implant of  claim 1 ; and   implanting the tracheal implant into a tracheal defect in a subject.   
     
     
         57 . The method of  claim 56 , wherein the subject is a human or other animal. 
     
     
         58 . The method of  claim 56 , comprising implanting the tracheal implant into a hole defect in the trachea. 
     
     
         59 . The method of  claim 56 , comprising implanting the tracheal implant in a circumferential tracheal defect. 
     
     
         60 . The method of  claim 56 , comprising treating tracheal stenosis. 
     
     
         61 . The method of  claim 56 , comprising a medical professional shaping the fibrous implant just before implantation to match a defect. 
     
     
         62 . The method of  claim 56 , comprising tracheal tissue regeneration.