Fenestration kits for making fenestrated placental tissue allografts and methods of using the same
View Patent ↗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.
1. A method for making a fenestrated placental tissue allograft, said method comprising:
i) providing a fenestration kit, said kit comprising:
a) 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
b) 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; and
wherein the cutting punches are sized and spaced so as to produce fenestrations which (a) are spaced from greater than 5 mm to about 20 mm apart as measured from the center of two adjacent fenestrations, and/or (b) are between greater than 2 mm to about 5 mm in size;
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;
iv) placing the assembled fenestration kit into a sealable bag and sealing the bag; and
v) applying pressure to the assembled fenestration kit such that the cutting punches perforate the allograft; thereby fenestrating the allograft.
2. The method of claim 1 , wherein the allograft is dehydrated.
3. The method of claim 1 , wherein the placental tissue allograft is dehydrated prior to placing the allograft on the cutting bed.
4. The method of claim 1 , wherein the placental tissue allograft comprises a first membrane and a second membrane.
5. The method of claim 4 , wherein the first membrane comprises amnion, chorion, or a laminate comprising one or more layers of amnion with one or more layers of chorion.
6. The method of claim 4 , wherein the second membrane comprises amnion, chorion, or a laminate comprising one or more layers of amnion with one or more layers of chorion.
7. The method of claim 4 , 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.
8. The method of claim 4 , 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.
9. The method of claim 4 , wherein the first membrane and/or second membrane are cross-linked.
10. The method of claim 1 , wherein the first material and/or second material is disposable.
11. The method of claim 1 , wherein the first material is selected from the group consisting of polypropylene, styrene, high impact polystyrene, polyvinylchloride, nylon, high density polyethylene, and stainless steel.
12. The method of claim 1 , wherein the second material is selected from the group consisting of low density polyethylene, silicone rubber, and isoprene rubber.
13. The method of claim 1 , wherein the cutting punches are substantially circular.
14. The method of claim 1 , wherein said cutting punches are symmetrically and/or uniformly distributed.