Lyophilized Pliable Bone Graft Composite for Shape Retention
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Solution Overview
Problem
Current bone graft substitutes and extenders face challenges such as biocompatibility issues, the need for multiple surgical procedures, limited availability of autologous bone, and the inability to maintain structural integrity and promote effective bone ingrowth, particularly in cases of significant bone loss or defects.
Innovation Solution
A composition combining a hydrogel material with anorganic bone mineral matrix and biologically active peptides, which is processed to create a firm but pliable medical device that can be lyophilized into various shapes, allowing for improved retention of shape and promotion of bone formation without the need for containment devices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If dry granulated or powdered allograft bone is used, then biocompatibility and bone integration are improved, but cohesiveness and adhesion for filling osseous defects are insufficient
Solution Approach 1:
The patent combines demineralized allograft bone particles with a hydrogel carrier material to create a composite substance. The hydrogel provides cohesiveness and adhesion properties that pure bone particles lack, while the bone particles maintain their biocompatibility and osteoinductive capabilities. This composite formulation allows the material to be applied and retained in osseous defects effectively.
2Reliability
If patient's own blood or bone marrow is used as carrier, then biocompatibility is improved, but mixing control and viscosity are not ideal
Solution Approach 1:
The patent uses a synthetic hydrogel carrier material that can be pre-formulated and sterilized, eliminating the need for intraoperative mixing with patient blood or bone marrow. This pre-prepared carrier provides consistent viscosity and mixing control while maintaining biocompatibility, simplifying the surgical procedure and reducing variability in the mixture.
3Ease of manufacture
If glycerol is used as carrier, then consistency and viscosity are suitable, but water solubility causes early dispersement of suspended bone
Solution Approach 1:
The patent modifies the chemical composition of the carrier by using a hydrogel material with specific rheological properties that provide suitable viscosity and consistency while being less water-soluble than glycerol. This parameter change in the carrier material's molecular structure prevents early dispersement of suspended bone particles while maintaining workability during application.
4Reliability
If autologous bone is harvested and used, then biocompatibility is maximized, but multiple surgical procedures and infection risk increase
Solution Approach 1:
The patent extracts and utilizes bone morphogenic proteins and osteoinductive factors from allograft bone material, concentrating these beneficial biological agents into a processed form that can be applied directly to the defect site. This extraction approach captures the essential bone-forming properties of autologous bone while eliminating the need for harvesting procedures.
5Quantity of substance
If allograft bone is used to fill large defects, then bone loss compensation is improved, but structural integrity and shape retention are insufficient
Solution Approach 1:
The patent creates a composite material where the hydrogel carrier provides structural framework and shape retention capabilities, while the suspended allograft bone particles provide osteoinductive properties. This composite structure allows the material to maintain its shape in large bone defects and be contoured to fit specific anatomical configurations.
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 composition effectively supports bone repair and growth by maintaining structural integrity, promoting osteogenic cell activity, and absorbing body fluids, reducing the risk of foreign material-related complications and enhancing bone regeneration.
Implementation Method 1
absorbing body fluids
Implementation Method 2
processed to create a firm but pliable medical device that can be lyophilized into various shapes
Data Source
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AI summary
A firm but pliable medical device for use as a bone graft substitute or bone graft extender retains its shape without the requirement of a containment device, such as a syringe. Because the device is solid, it is easy to locate or position in-vivo and, in the moist environment of the body, it will hold its shape well, for an extended time. Because the lyophilized pliable medical device is porous, it adsorbs blood and other beneficial cells containing body fluids, such as bone marrow, contributing to its superior bone repair efficacy in comparison to an analogous putty that has not been lyophilized. In addition these lyophilized pliable medical devices are easier to terminally steam sterilize than the analogous putty because there is no moisture present to boil and "blow-out" of the containment device (syringe). The glycerin that is present in the formulation lends pliability but has a low vapor pressure.