Infused demineralized bone fibers

Inventors

Ganey, Timothy • Anderson, Tracy Scott • Temple, Harry Thomas

Assignees

Vivex Biologics Group Inc

Abstract

A method of making infused bone fibers employs the following steps: cutting or shaving whole bone into bone fibers, washing the bone fibers, demineralizing or decalcifying at least partially the whole bone or bone fibers and infusing the bone fibers with a supernatant of biologic material or a polyampholyte cryoprotectant or a combination of both to create infused bone fibers. The step of infusing includes exposing the bone fibers to a negative pressure or vacuum to draw the supernatant and/or the polyampholyte cryoprotectant into the bone fibers, or alternatively, exposing the demineralized whole bone to a positive pressure to drive the supernatant and/or the polyampholyte cryoprotectant into the bone. The resultant method creates an infused bone grafting composition having bone fibers taken from whole bone, demineralized or decalcified at least partially and infused with one or more of a supernatant of biologic material or a polyampholyte cryoprotectant or both.

Core Innovation

The invention relates to a method of making infused demineralized bone fibers. Whole bone is cut or shaved into bone fibers, washed, and then demineralized, and the demineralized bone fibers are infused with a biological mixture that includes a supernatant of biologic material and a polyampholyte cryoprotectant to create infused demineralized bone fibers.

Infusion is performed by exposing the demineralized bone fibers to negative pressure or vacuum to draw the biological mixture and the polyampholyte cryoprotectant into the bone fibers, and thereafter the demineralized whole bone is exposed to a positive pressure to drive the biological mixture and the polyampholyte cryoprotectant into the bone fibers. Whole cells, if any, are optionally present in an optional buffy layer, and their membrane contents are described as ruptured during processing.

After infusion, the infused demineralized bone fibers are frozen and dried by freeze-drying (lyophilization). The infused demineralized bone fibers are storable at ambient or room temperature suitable for implantation with no rinsing or washing, and before implantation into a patient in need of bone regeneration and repair, the infused demineralized bone fibers are rehydrated and diluted.

The composition is described as long aspect-ratio bone fibers from whole bone, washed and demineralized, including demineralized or partially decalcified fibers, and then infused with either or both an acellular bone-marrow supernatant and a polyampholyte cryoprotectant. The biological mixture is described as mechanically selected marrow-derived fractions that include vesicular components and exosomes and may include optional whole cells with contents released by membrane rupture.

Claims Coverage

The patent includes one independent method claim with several dependent claims. The inventive features are centered on making infused demineralized bone fibers using a supernatant plus polyampholyte cryoprotectant, using sequential negative pressure or vacuum and positive pressure infusion, and producing ambient-temperature or room-temperature storable freeze-dried fibers for implantation with rehydration and dilution prior to use.

Across the independent and dependent claims, the method centers on making infused demineralized bone fibers using a biological mixture of a supernatant plus a polyampholyte cryoprotectant, delivered by sequential negative pressure or vacuum and positive pressure, followed by freezing and freeze-drying to yield ambient or room temperature storable fibers. Dependent claims further specify long fiber length, shaped formation using a cutting die, optional cross-sectional geometry, and optional post-drying shaping into sheets or matting.

Stated Advantages

Documented Applications