Modified demineralized cortical bone fibers
AssigneeMusculoskeletal Transplant Foundation
InventorsMichele McAllister, David Wang, Michelle Bubear, Joed Canales, Amy Chang, Roman Shikhanovich, Mark Spilker, Eric Semler
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Abstract
Methods for making surgical implants (or grafts) for the repair of bone defects, and more particularly, surgical implants that include demineralized bone fibers, are disclosed. Also disclosed are methods for increasing the wettability and ensuring uniform density of such implants. The surgical implants have a wettability time of less than 5 minutes and a residual moisture content of less than 6% by weight, and they remain cohesive and retain their shape upon complete rehydration.
Claims17
A method for producing an implant from modified demineralized cortical bone fibers, said method comprising the steps of:
- contacting the demineralized cortical bone fibers with a salt solution prior to lyophilizing;
- and
- shaping a mass of demineralized cortical bone fibers to form an implant having a desired shape;
- lyophilizing the implant.
A method for producing an implant from modified demineralized cortical bone fibers, said method comprising the steps of:
- shaping a mass of demineralized cortical bone fibers to form an implant having a desired shape;
- curing the implant at a temperature of from about 20° C. to about 50° C. for a period of up to about 48 hours by one or more techniques selected from air drying, heat drying and applying energy to the implant, said curing step being performed prior to said lyophilizing step;
- and
- lyophilizing the implant.
A method for increasing wettability of an implant comprising demineralized cortical bone fibers, said method comprising the steps of:
- providing cortical bone fibers;
- demineralizing said cortical bone fibers to form demineralized cortical bone fibers;
- optionally, restoring the demineralized cortical bone fibers to have a physiological pH;
- combining the demineralized cortical bone fibers with a liquid to produce a solution;
- agitating the solution to homogenously disperse the demineralized cortical bone fibers in the solution;
- placing the solution in an implant forming container, wherein the implant forming container is a shaped container or a reservoir of a press mold;
- optionally, compressing the demineralized cortical bone fibers to a predetermined uniform density in the container to form the implant;
- separating a majority of the liquid from the demineralized cortical bone fibers, wherein separation is accomplished by one or more techniques selected from air-drying, heat drying, use of a sieve, use of a perforated plunger in a press mold;
- optionally, removing the separated liquid from the container;
- optionally, disinfecting the implant;
- optionally, storing the implant in a freezer for up to 24 hours;
- curing the implant by one or more techniques selected from air-drying for up to 48 hours, applying radiant heat to the implant, applying energy to the implant;
- exposing the implant to one or more of:
- a biocompatible polar molecule selected from an alcohol, a polyol, a sugar, a ketone, an aldehyde, an organic acid, or combinations thereof, a salt solution, or energy selected from UV light, microwave energy, and combinations thereof;
- lyophilizing the implant.
Dependencies are inferred from the claim text.