Demineralized bone fiber implant compositions and methods for augmenting fixation in bone repair

Abstract

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 .- 20 . (canceled) 
     
     
         21 . A composition, comprising an implant for bone repair, the implant comprising:
 a proximal end and a distal end; and   a plurality of cut demineralized bone fibers (DBFs) having a length of between about 1 cm to about 30 cm,   wherein the plurality of cut DBFs form a shape selected from a cylinder, a tube, a cannulated cylinder, a truncated cone, or a cannulated truncated cone, and   wherein the implant is dehydrated.   
     
     
         22 . The composition of claim  1 , wherein the implant has a length of between 2 cm to 10 cm. 
     
     
         23 . The composition of claim  1 , wherein the plurality of cut DBFs have a length of between about 3 cm to about 10 cm. 
     
     
         24 . The composition of claim  1 , wherein the plurality of cut DBFs have a length of between about 1 cm to about 4 cm. 
     
     
         25 . The composition of claim  1 , wherein the implant has a diameter of between about 2 to about 7 mm. 
     
     
         26 . The composition of claim  1 , wherein the implant has a diameter of between about 2 to about 5 mm. 
     
     
         27 . The composition of claim  1 , wherein the implant has a length of between about 3 cm and 10 cm. 
     
     
         28 . The composition of claim  1 , wherein the implant has a volume of between about 0.15 cm 3  up to 10 cm 3 . 
     
     
         29 . The composition of claim  1 , wherein the implant has a volume of between about 0.15 cm 3  up to 2.0 cm 3 . 
     
     
         30 . The composition of claim  1 ,
 wherein the plurality of cut DBFs have a length of between about 1 cm to about 4 cm and form a shape selected from a truncated cone with a flared end, a cannulated truncated cone with a flared end, or a tube with a flared end,   wherein the flared end is at the proximal end of the implant, and   wherein the flared end comprises an indent for receiving the screw.   
     
     
         31 . The composition of claim  11 , wherein the flared end has a diameter of between about 2 to 7 mm. 
     
     
         32 . The composition of claim  1 , wherein the implant further comprises mineralized bone fibers added to the plurality of cut DBFs. 
     
     
         33 . The composition of claim  1 , wherein the implant further comprises cancellous or cortical bone chips and/or demineralized cancellous or cortical bone chips added to the plurality of cut demineralized bone fibers. 
     
     
         34 . The composition of claim  1 , wherein the implant further comprises calcium phosphate, tri-calcium phosphate, or hydroxyapatite added to the plurality of demineralized bone fibers. 
     
     
         35 . The composition of claim  1 , wherein the implant further comprises one or more of the following added to the plurality of cut DBFs:
 i. mineralized bone fibers;   ii. cancellous or cortical bone chips;   iii. demineralized cancellous or cortical bone chips; and/or   iv. calcium phosphate, tri-calcium phosphate, or hydroxyapatite.   
     
     
         36 . A composition, comprising an implant for bone repair, the implant comprising:
 a proximal end and a distal end; and   a plurality of cut demineralized bone fibers (DBFs) having a length of between about 1 cm to about 30 cm,   wherein the plurality of cut DBF form a shape selected from a truncated cone with a flared end, a cannulated truncated cone with a flared end, or a tube with a flared end,   wherein the flared end is at the proximal end of the implant,   wherein the flared end comprises an indent for receiving the screw, and   wherein the implant is dehydrated.   
     
     
         37 . The composition of claim  16 ,
 wherein the plurality of cut DBFs have a length of between about 1 cm and 4 cm, and   wherein the flared end has a diameter of between about 2 mm and 7 mm.   
     
     
         38 . A kit for augmenting fixation of a screw in a bone with an implant, the kit comprising:
 the implant of claim  1 .   
     
     
         39 . 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.   
     
     
         40 . The kit of claim  19 , wherein the guide wire and the awl or the tap are disposable.