MOLDS FOR FORMING DERMAL ALLOGRAFT IMPLANTS AND DERMAL ALLOGRAFT IMPLANTS FORMED FROM SAME
The present disclosure includes devices, apparatuses, and methods for forming lyophilized soft-tissue allografts for the correction of skeletal impairments (e.g., misalignments, arthritis, etc.), and soft-tissue allograft implants formed from the same.
1 . A mold for forming lyophilized allograft implants, comprising:
a body having a first side and a second side and defining a chamber for receiving an allograft tissue, the chamber having a periphery extending between and through the first side and the second side;
a first end cap configured to be coupled to the first side of the body over the chamber, the first end cap having a body-facing side with a surface portion that is aligned with the chamber when the first end cap is coupled to the body, and an outer side defining a plurality of holes extending between and through the outer side and the body-facing side and in fluid communication with the surface portion of the first end cap; and
a second end cap configured to be coupled to the second side of the body over the chamber, the second end cap having a body-facing side with a surface portion that is aligned with the chamber when the second end cap is coupled to the body, and an outer side defining a plurality of holes extending between and through the outer side and the body-facing side and in fluid communication with the surface portion of the second end cap.
2 . The mold of claim 1 , where the body, having a first portion and a second portion, defines the chamber when the first portion and the second portion are coupled together.
3 . The mold of claim 1 , where the first end cap and the second end cap are coupled to the body to compress and form the allograft tissue into a shape conforming to the chamber during lyophilization, and/or the first portion and the second portion of the body are coupled to compress and form the allograft tissue into a shape conforming to the chamber during lyophilization.
4 . The mold of claim 1 , where the chamber is cylindrical.
5 . The mold of claim 1 , where the surface portion of the first end cap is convex and the surface portion of the second end cap is convex.
6 . The mold of claim 1 , where the surface portion of the first end cap is concave and the surface portion of the second end cap is concave.
7 . The mold of claim 1 , where the surface portion of the first end cap is convex and the surface portion of the second end cap is concave.
8 . The mold of claim 1 , where the surface portion of the first end cap is concave and the surface portion of the second end cap is convex.
9 - 14 . (canceled)
15 . The mold of claim 1 , where the body has a peripheral surface extending between the first side and the second side, and defining one or more suture passages extending through the peripheral surface and into the chamber.
16 . A dermal allograft comprising:
a body having a first end and a second end, the allograft comprising lyophilized and compressed tissue layers between the first end and the second end, where the body has a periphery corresponding to the shape of the chamber of the mold of claim 1 .
17 . The dermal allograft of claim 16 , where each of the first and second ends is concave.
18 . The dermal allograft of claim 16 , where each of the first and second ends is convex.
19 . The dermal allograft of claim 16 , where the first end is convex and the second end is concave.
20 . The dermal allograft of claim 16 , where the first end is concave and the second end is convex.
21 . The dermal allograft of claim 16 , where the peripheral surface is cylindrical and has a circular cross-sectional shape.
22 - 25 . (canceled)
26 . The dermal allograft of claim 16 , where the body defines a plurality of suture passages extending transversely through the body.
27 . The dermal allograft of claim 16 , where the body defines a plurality of suture passages extending longitudinally through the first end and the second end.
28 - 29 . (canceled)
30 . The dermal allograft of claim 16 , where the body defines one or more channels extending between and through the first end and second end.
31 - 33 . (canceled)
34 . A method comprising:
(a) inserting a soft-tissue allograft into the chamber of the mold of claim 1 ;
(b) coupling the first end cap and second end cap to the body to compress the soft-tissue allograft and/or coupling the first portion and second portion of the body to compress the soft-tissue allograft; and
(c) lyophilizing the soft-tissue allograft disposed within the chamber.
35 . The method of claim 34 , where the soft-tissue allograft is lyophilized anywhere from 10% to 90% prior to inserting into the chamber of the mold of claim 1 .