Demineralized Bone Gel Sheet Composition for Defect Repair
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Solution Overview
Problem
Existing bone graft materials struggle to maintain position and shape during bone repair, particularly when used in osseous defects and bone voids, as they lack the necessary conformability and cohesion to effectively mold and adhere to the defect site.
Innovation Solution
A demineralized bone gel composition is developed by processing cortical bone into particles, mixing with sterile water, and autoclaving to form a gelatinous sheet that can be shaped and frozen for use, providing a cohesive and moldable product that can be mixed with autograft or allograft particles for enhanced bone repair.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If bone graft materials are used in osseous defects, then bone repair is facilitated, but the materials fail to maintain position and shape during repair
Solution Approach 1:
The patent transforms the physical state of bone graft material from dry particles to a gelatinous form through controlled hydration and autoclaving. This parameter change (from solid particles to gel) enables the material to maintain position and shape while still facilitating bone repair, resolving the contradiction between repair effectiveness and stability.
Solution Approach 2:
The invention creates a composite bone gel by combining demineralized bone matrix particles with autologous serum or plasma. This composite structure provides both the osteoinductive properties needed for bone repair and the gelatinous consistency required for position and shape maintenance, simultaneously addressing both requirements.
2Reliability
If bone graft materials are used for bone repair, then new bone growth is promoted, but the materials lack conformability and cohesion to mold and adhere to defect sites
Solution Approach 1:
The patent changes the physical parameters of bone graft material from dry, free-flowing particles to a cohesive gelatinous mass through controlled hydration and thermal processing. This transformation enables the material to be molded and shaped while retaining its osteoinductive capabilities, resolving the contradiction between bone growth promotion and ease of operation.
Solution Approach 2:
The invention uses autologous serum or plasma as an intermediary substance that binds demineralized bone matrix particles together to form a cohesive gel. This intermediary provides both the binding/cohesion needed for molding and the biological factors necessary for promoting new bone growth.
3Stability of the object's composition
If collagen or gelatinous materials are added to bone particles to create malleable paste, then position retention is improved, but the complexity of the formulation increases
Solution Approach 1:
The patent employs autologous serum or plasma from the patient's own body as the gelatinous binding agent, eliminating the need for additional exogenous collagen or gelatin materials. This self-service approach maintains position retention while reducing formulation complexity by using a naturally available substance.
Solution Approach 2:
The invention achieves gelatinous consistency through controlled hydration and autoclaving of demineralized bone particles with autologous fluid, rather than adding external gel-forming materials. This parameter-based approach simplifies the formulation by relying on physical-chemical transformations of the bone particles themselves.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The bone gel composition maintains its shape in saline and can be molded into desired forms, offering improved handling and adherence to bone defects, facilitating effective bone growth and repair by serving as a binding agent with autograft or allograft particles.
Implementation Method 1
the mixture is autoclaved under heat and pressure to form a gelatin
Implementation Method 2
Freeze Dried/Lyophilized—Tissue dehydrated for storage by conversion of the water content of frozen tissue to a gaseous state under vacuum that extracts moisture
Implementation Method 3
The resulting bone gel is formed into sheets having a thickness (t) and frozen for later use, preferably frozen at a temperature of −20 to −80 degrees C
Data Source
AI summary
A bone gel composition consists of cortical bone. The cortical bone is made from cut pieces freeze-dried then ground into particles and demineralized then freeze-dried. A volume of the particles is placed in a solution of sterile water to create a mixture, the water volume being at least twice the particle volume, the mixture is autoclaved under heat and pressure to form a gelatin, the resulting bone gel is formed into sheets having a thickness (t).