Infused demineralized bone fibers
Inventors
Ganey, Timothy • Anderson, Tracy Scott • Temple, Harry Thomas
Assignees
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Publication Number
US-12171907-B2
Publication Date
2024-12-24
Expiration Date
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 provides a method of making infused at least partially demineralized or at least partially decalcified bone fibers by cutting or shaving whole bone into bone fibers and washing the bone fibers. The method includes at least partially demineralizing or at least partially decalcifying the bone fibers to create a surface demineralization or decalcification that extends into the bone fibers. The infused bone fibers are created by infusing the at least partially demineralized or at least partially decalcified bone fibers with a supernatant of biologic material and a polyampholyte cryoprotectant.
The invention further defines infusion as exposing the at least partially demineralized or at least partially decalcified bone fibers, the supernatant of biologic material, and the polyampholyte cryoprotectant to either a negative pressure or vacuum to draw the supernatant and polyampholyte cryoprotectant into the bone fibers, or to a positive pressure to drive the supernatant and polyampholyte cryoprotectant into the bone fibers. The polyampholyte cryoprotectant is described as forming an externally enveloping coating intended to buffer inflammation, sustain regenerative function, enhance exosome absorption, and enable charge and gradient effects to enable nano-dimension control.
The invention also describes making an infused bone fiber mixture by at least partially demineralizing or at least partially decalcifying whole bone, then cutting or shaving the whole bone into bone fibers to form a bone fiber mixture including quantities of one or more bone fiber types. The bone fiber mixture can include fully decalcified or fully demineralized bone fibers, at least partially decalcified or at least partially demineralized bone fibers, and/or mineralized and calcified bone fibers, and it is washed before infusion. The bone fiber mixture is infused with a supernatant of biologic material and a polyampholyte cryoprotectant by exposing to a negative pressure or vacuum to draw or a positive pressure to drive the supernatant and polyampholyte cryoprotectant into the bone fibers, and may be further processed to form sheets, mats, laminates, and stacked forms.
Claims Coverage
The independent claims cover two related method categories: making infused at least partially demineralized or at least partially decalcified bone fibers and making an infused bone fiber mixture. Each independent claim includes three core inventive features: the prepared bone fiber substrate with surface demineralization/decalcification, infusion with a biologic-material supernatant plus a polyampholyte cryoprotectant, and infusion driven by either negative pressure/vacuum or positive pressure.
Infused at least partially demineralized or at least partially decalcified bone fibers substrate
Cutting or shaving whole bone into bone fibers, washing the bone fibers, and at least partially demineralizing or at least partially decalcifying the bone fibers to create a surface demineralization or decalcification that extends into the bone fibers.
Infusion with biologic-material supernatant and polyampholyte cryoprotectant
Infusing the at least partially demineralized or at least partially decalcified bone fibers with a supernatant of biologic material and a polyampholyte cryoprotectant to create infused at least partially demineralized or at least partially decalcified bone fibers.
Pressure-driven infusion into bone fibers
Infusing comprises exposing the at least partially demineralized or at least partially decalcified bone fibers, supernatant of biologic material, and polyampholyte cryoprotectant to a negative pressure or vacuum to draw the supernatant and polyampholyte cryoprotectant into the bone fibers, and/or exposing the at least partially demineralized or at least partially decalcified bone fibers, supernatant of biologic material, and polyampholyte cryoprotectant to a positive pressure to drive the supernatant and polyampholyte cryoprotectant into the bone fibers.
Infused bone fiber mixture with multiple bone fiber types
At least partially demineralizing or at least partially decalcifying whole bone; cutting or shaving the at least partially demineralized or at least partially decalcified whole bone into bone fibers forming a bone fiber mixture including quantities of one or more bone fiber types of fully decalcified or fully demineralized bone fibers, at least partially decalcified or at least partially demineralized bone fibers, or mineralized and calcified bone fibers, or a mixture of two or more of said bone fiber types; and washing the bone fiber mixture.
Infusion of the bone fiber mixture with biologic-material supernatant and polyampholyte cryoprotectant
Infusing the bone fiber mixture with a supernatant of biologic material and a polyampholyte cryoprotectant to create an infused bone fiber mixture.
Pressure-driven infusion into the bone fiber mixture
Infusing comprises exposing the bone fiber mixture, supernatant of biologic material, and polyampholyte cryoprotectant to a negative pressure or vacuum to draw the supernatant and polyampholyte cryoprotectant into the bone fibers, or exposing the bone fiber mixture, supernatant of biologic material, and polyampholyte cryoprotectant to a positive pressure to drive the supernatant and polyampholyte cryoprotectant into the bone fibers.
Across the independent claims, the inventive scope centers on preparing bone-derived fiber substrates with surface demineralization or decalcification, infusing them (as fibers or as a mixture of fiber types) with a supernatant of biologic material and a polyampholyte cryoprotectant, and achieving infusion by either negative pressure/vacuum draw-in or positive pressure drive-in.
Stated Advantages
Buffer inflammation.
Sustain regenerative function.
Enhance exosome absorption.
Create charge and gradient effects to enable nano-dimension control.
Documented Applications
Creating infused demineralized bone fiber and infused bone fiber mixture constructs for use as long-fiber mats/sheets and laminated stack forms, as described in the disclosed processing and shaping.
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