Demineralized bone fiber implant compositions and methods for augmenting fixation in bone repair
a bone fiber and composition technology, applied in the field of bone fiber implant composition and methods, can solve the problems of affecting the stability of the implant, the most susceptible region of the bone screw interface to loosen and fail, and the difficulty of modern spine surgical techniques in achieving and maintaining fixation in osteoporotic vertebrae, etc., to achieve the effect of increasing the effectiveness of sutures and increasing the stability of implants
Pending Publication Date: 2021-05-27
THERACELL LLC
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- Summary
- Abstract
- Description
- Claims
- Application Information
AI Technical Summary
Benefits of technology
The demineralized bone fiber implants increase insertion torque and pull-out resistance of screws, reduce the likelihood of screw dislodgment, and facilitate permanent bone repair by promoting osteoinduction and osteoconduction, especially in osteoporotic bone, making revision surgeries more manageable.
Problems solved by technology
Modern spine surgical techniques encounter difficulty in achieving and maintaining fixation in osteoporotic vertebrae in the case of fracture and / or deformity.
The bone-screw interface is typically the region most susceptible to loosening and failure.
A significant portion of these cases will sustain catastrophic failure after attempted surgical fixation.
As a result, some spine surgeons may refuse to perform stabilization surgery on osteoporotic patients with fractures and / or severe deformities.
Use of cement to augment traditional pedicle screw fixation generally yields increased resistance to pullout and / or toggle failure in the cephalad-caudad direction as reported in numerous studies, but there are associated potential morbidities such as spinal canal extrusion or vascular flow obstruction.
A further and significant disadvantage of the use of PMMA screw augmentation is that it is a non-biological repair that make revision or re-operation very difficult.
Similar problems of initial fixation strength and subsequent loosening and failure exist with the use of screws in orthopedic procedures such as hip fractures that often occur in patients with osteoporotic or otherwise compromised bone.
Implant loosening however remains a problem and concern to orthopedists.
When tendon or ligament tissues or grafts are placed either in apposition to bone, as in the case of rotator cuff repair or in bone tunnels as in anterior cruciate ligament repair, the creation or recreation of the tendon-bone enthesis is a problem and concern to orthopedists.
Method used
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Examples
Experimental program
Comparison scheme
Effect test
example 1
[0177]1 ml disposable plastic syringes were used as a mold. The plungers were removed and 0.25 grams of DBF were introduced into the end of the syringe and the plunger used to lightly compress the fibers to a length of approximately 4cm. The plungers were removed and the tip of the syringe cut off using a scalpel. The implants were vacuum dried overnight at 27° C. The resultant implants were approximately 4.5 mm in diameter
example 2
[0178]Three implants from Example 1 were used to test for augmentation of screw pull out. A Sawbones 10 pores per inch foam that is frequently used to test screw pull out as a surrogate for osteopenic bone was used. Six 5 mm diameter holes were drilled in the foam block. Implants from example 1 were placed in three of the holes. 5.5 mm pedicle screws were inserted into the six holes. An MTS tensile test machine was used to record the force required to pull the screws out of the holes. The data obtained are shown in Table 1 below.
TABLE 1Peak Force (N)ControlAugmentedTest 1346764Test 2338868Test 3290778Average325803
example 3
[0179]15 grams of DBF fiber were wet laid in a 10 cm×11 cm flat mold to produce a sheet of DBF. The mold was heated at 55 ° C. for two hours to bond the fibers and dry the sheet. The sheet was approximately 1 mm thick. A portion of the sheet would be suitable for use in augmenting ACL or rotator cuff fixation.
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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.
Description
[0001]This application is a divisional application of co-pending U.S. application Ser. No. 16 / 785,522 filed on Feb. 7, 2020 which claims priority to U.S. Provisional Application No. 62 / 803,470 filed on Feb. 9, 2019 and U.S. Provisional Application No. 62 / 901,935 filed on Sep. 18, 2019, the entire contents of all of which are herein incorporated by reference.FIELD OF THE INVENTION[0002]The field of the invention relates to composition and methods of bone fiber implants made from cortical bone in which a plurality of demineralized bone fibers are shaped having a peg portion and a sheet portion to augment tendon to bone repair or shaped to be placed in a hole of a bone prior to insertion of a screw.BACKGROUND[0003]The background description includes information that may be useful in understanding the present disclosure. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or ...
Claims
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Patent Timeline
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IPC IPC(8): A61L27/36A61F2/30A61B17/88A61B17/86A61B17/68
CPCA61L27/3608A61F2/30965A61L27/365A61B17/16A61B17/8897A61B17/86A61B17/686A61L27/3695A61L27/56A61F2002/30205A61F2002/30224A61F2002/30235A61F2/28A61F2002/2835A61B17/0401A61B17/8645A61B17/8875A61B2090/062A61L27/58
InventorCARTER, ANDREW J.PATT, BRADLEY E.ANDERSSON, GUNNARMCRURY, IANVERMA, NIKHILSCARBOROUGH, NELSON L.
OwnerTHERACELL LLC