DEMINERALIZED BONE FIBER IMPLANT COMPOSITIONS AND METHODS FOR AUGMENTING FIXATION IN BONE REPAIR
A composition and methods of making or use thereof include a plurality of fibers forming a shape for augmenting fixation of a bone screw, or the plurality of fibers form a shape having a peg portion and a sheet portion to augment tendon to bone repair. The physical presence of the plurality of fibers provides initial fixation, while the use of an osteoinductive material provides long term enhancement of bone formation around the site of the bone screw or the tendon to bone repair.
1 . A composition, comprising an implant for bone repair, the implant comprising:
a plurality of fibers selected from demineralized bone fibers (DBF), biocompatible polymer fibers, collagen fibers, and/or resorbable polymer fibers;
wherein the plurality of fibers form a shape of a cylinder, a tube, a cannulated cylinder, a truncated cone, a cannulated truncated cone, a truncated cone with a flared end, or a cannulated truncated cone with a flared end, tube with a flared end, or a truncated cone shape,
wherein the implant has a proximal end and a distal end, and
wherein the flared end is at the proximal end of the implant.
2 . The composition of claim 1 , wherein the plurality of fibers comprise demineralized bone fibers (DBF).
3 . The composition of claim 1 , wherein the implant has a volume of between 0.15 cm 3 to 10 cm 3 .
4 . The composition of claim 1 , wherein the implant has a length of between 1 cm to 10 cm.
5 . The composition of claim 1 , wherein the flared end comprises an indent for receiving a bone screw.
6 . The composition of claim 1 , wherein the implant is dehydrated.
7 . A method of augmenting fixation of a screw in a bone with the implant of claim 1 , the method comprising:
optionally placing a guide wire to define a position in the bone for the screw;
inserting or providing the implant to a cavity in the bone; and
inserting or providing the screw into the implant.
8 . The method of claim 7 , wherein when the guide wire is used, the providing the implant comprises placing the implant on the guide wire through the cannulated, tubular, or cone shape of the implant and moving the implant along the guide wire into the cavity.
9 . The method of claim 7 , wherein the moving the implant along the guide wire comprises using an awl, a pusher, a tap, and/or a drill.
10 . The method of claim 7 , wherein the cavity in the bone is formed using an awl, a pusher, a tap, and/or a drill.
11 . A method of augmenting fixation of a screw in a bone with the implant of claim 1 , the method comprising:
placing a guide wire to define a position in the bone for the screw;
inserting or providing the implant to a cavity in the bone; and
inserting or providing the screw into the implant.
12 . The method of claim 11 , wherein the inserting or providing the implant or the screw comprises using a cannulated instrument.
13 . The method of claim 11 wherein the inserting or providing the implant comprises an open-ended syringe comprising the implant.
14 . A method of fabricating the implant of claim 1 , the method comprising:
dispersing the plurality of fibers in a fluid;
wherein the plurality of fibers and the fluid are in a ratio of between about 1 gram of fibers to about 3 mls to 50 mls of the fluid; and
providing the dispersed plurality of fibers with pressure into a vented mold thereby draining the fluid from the mold.
15 . The method of claim 14 , further comprising heating the plurality of fibers in the mold at or between about 35 to 55 degrees Celsius.
16 . The method of claim 14 , wherein the plurality of fibers comprise demineralized bone fibers, biocompatible polymer fibers, collagen fibers, and/or resorbable polymer fibers.
17 . The method of claim 14 , wherein the plurality of fibers are lyophilized.
18 . A kit for augmenting fixation of a screw in a bone with an implant, the kit comprising:
the implant of claim 1 .
19 . The kit of claim 18 , further comprising:
a guide wire;
an awl or a tap;
and/or a screw to be place in the bone to be repaired.
20 . The kit of claim 19 , wherein the guide wire and the awl or the tap are disposable.