Fenestration kits for making fenestrated placental tissue allografts and methods of using the same

Abstract

Described herein are fenestrated placental tissue allografts, methods for using the same for treating wounds that produce an exudate and to promote the healing process, and apparatus and kits for making the same that minimize or eliminate cross-contamination with placental tissue from other placental donors.

What is claimed is: 
     
         1 . A fenestrated placental tissue allograft for treating a topical wound that produces an exudate, said allograft comprising placental tissue from a single placental donor and substantially free of placental tissue from any other placental donor, said allograft comprising:
 a first surface;   a second surface; and   a plurality of fenestrations in direct communication with said first surface and said second surface,   wherein said fenestrations are distributed throughout said allograft,   wherein at least one of said first surface and said second surface provides a surface area substantially in direct contact with said wound that is sufficient to treat the wound,   wherein said fenestrations are substantially free of allograft tissue obstruction to permit the free flow of exudate away from said wound and through said fenestrations, and   wherein said allograft facilitates healing of said wound without substantial contamination from another placental donor tissue.   
     
     
         2 . The allograft of  claim 1 , wherein the allograft is dehydrated. 
     
     
         3 . The allograft of  claim 1 , wherein said wound is an acute wound. 
     
     
         4 . The allograft of  claim 1 , wherein said wound is a chronic wound. 
     
     
         5 . The allograft of  claim 1 , wherein said fenestrations are spaced from about 1.5 mm to about 10 mm apart as measured from the center of two adjacent fenestrations. 
     
     
         6 . The allograft of  claim 1 , wherein said fenestrations are substantially circular. 
     
     
         7 . The allograft of  claim 6 , wherein said circular fenestrations are at least about 0.5 mm diameter. 
     
     
         8 . The allograft of  claim 1 , wherein the placental tissue comprises a first membrane and a second membrane. 
     
     
         9 . The allograft of  claim 8 , wherein the first membrane comprises amnion, chorion, or a laminate comprising one or more layers of amnion with one or more layers of chorion. 
     
     
         10 . The allograft of  claim 8 , wherein the second membrane comprises amnion, chorion, or a laminate comprising one or more layers of amnion with one or more layers of chorion. 
     
     
         11 . The allograft of  claim 8 , wherein the first membrane comprises modified amnion having a first side which is an exposed basement membrane and a second side which is an exposed fibroblast layer comprising fibroblast cells, and optionally wherein the second membrane comprises chorion and the chorion is adjacent to the second side of the amnion. 
     
     
         12 . The allograft of  claim 8 , wherein the first membrane comprises modified amnion having a first side which is an epithelial layer and a second side which is an exposed fibroblast layer comprising fibroblast cells, and optionally wherein the second membrane comprises chorion and the chorion is adjacent to the second side of the amnion. 
     
     
         13 . The allograft of  claim 8 , wherein the first membrane and/or second membrane are cross-linked. 
     
     
         14 . A wound dressing comprising the allograft of  claim 1 . 
     
     
         15 . A method for treating a topical wound that produces an exudate, said method comprising:
 a.) placing on said wound the fenestrated placental tissue allograft of  claim 1 ; and   b.) maintaining said allograft on said wound while removing the exudate using negative pressure protocols.   
     
     
         16 . The method of  claim 15 , further comprising:
 c) placing at least one additional allograft onto said wound.   
     
     
         17 . The method of  claim 16 , when step c) is performed after the allograft of step a) has been absorbed or partially absorbed by the wound. 
     
     
         18 . A fenestration kit for making a fenestrated placental tissue allograft, said kit comprising:
 a cutting die comprising a substantially flat die surface having predetermined dimensions and having a first side and a second side, said first side having a plurality of prearranged cutting punches thereon, wherein the cutting die is made of a first material; and   a cutting bed having substantially the same dimensions as the cutting die, wherein the cutting bed is made of a second material;   wherein the first material is harder than the second material.   
     
     
         19 . The fenestration kit of  claim 18 , further comprising:
 a bag, said bag comprising a sealable opening and having at least the dimensions of said cutting die and said cutting bed.   
     
     
         20 . The fenestration kit of  claim 18 , wherein the first material and/or second material is disposable. 
     
     
         21 . The fenestration kit of  claim 18  which is sterile. 
     
     
         22 . The fenestration kit of  claim 18 , wherein the first material is selected from the group consisting of polypropylene, styrene, high impact polystyrene, polyvinylchloride, nylon, high density polyethylene, and stainless steel. 
     
     
         23 . The fenestration kit of  claim 18 , wherein the second material is selected from the group consisting of low density polyethylene, silicone rubber, and isoprene rubber. 
     
     
         24 . The fenestration kit of  claim 18 , wherein the cutting punches are spaced from about 1.5 mm to about 20 mm apart as measured from the center of two adjacent cutting punches. 
     
     
         25 . The fenestration kit of  claim 18 , wherein the cutting punches are substantially circular. 
     
     
         26 . The fenestration kit of  claim 25 , wherein said cutting punches are at least about 0.5 mm in diameter. 
     
     
         27 . The fenestration kit of  claim 18 , wherein said cutting punches are symmetrically and/or uniformly distributed. 
     
     
         28 . A method for making a fenestrated placental tissue allograft, said method comprising:
 i.) providing the fenestration kit of  claim 18 ;   ii.) placing a placental tissue allograft on the cutting bed;   iii.) placing the cutting die on top of the allograft such that the first side of the cutting die is adjacent to said allograft, thereby creating an assembled fenestration kit; and   iv.) applying pressure to the assembled fenestration kit such that the cutting punches perforate the allograft;   thereby fenestrating the allograft.   
     
     
         29 . The method of  claim 28 , further comprising placing the assembled fenestration kit into a sealable bag and sealing the bag. 
     
     
         30 . The method of  claim 28 , wherein the placental tissue allograft is dehydrated prior to placing the allograft on the cutting bed.