Cold-Cleaning Bone Grafts for Pathogen Removal and Collagen Integrity
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Solution Overview
Problem
Existing bone graft cleaning processes fail to effectively remove bone marrow, prions, bacteria, and viruses while maintaining the polycrystalline mineral structure and collagen integrity, leading to potential health risks and mechanical instability.
Innovation Solution
A low-temperature cleaning process combining mechanical and chemical treatments, including soaking in distilled water, slightly alkaline solutions, organic solvents, alkaline solutions, and oxidizing agents, with centrifugation and sonication, to decellularize bone and osteochondral tissues.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If high temperature sintering (650-1200 °C) is used to eliminate pathogens, then pathogen removal is effective, but the collagen structure is destroyed and mineral structure becomes overly crystalline
Solution Approach 1:
The patent changes the temperature parameter from high (650-1200 °C) to low (below 60 °C) and uses chemical agents (enzymes, detergents, oxidizing agents) instead of thermal energy to achieve pathogen elimination while preserving the organic matrix structure
Solution Approach 2:
The patent replaces the thermal-mechanical sintering process with a chemical cleaning process using enzymes, detergents, and oxidizing agents to remove pathogens without destroying the collagen-mineral composite structure
2Object-affected harmful factors
If strong chemical agents (sodium hydroxide, hydrogen peroxide) are used for pathogen inactivation, then pathogen removal is effective, but the mineral and collagen structure is damaged
Solution Approach 1:
The patent changes the concentration and type of chemical agents used, employing milder enzymes and controlled amounts of detergents and oxidizing agents at low temperatures to reduce structural damage while maintaining pathogen elimination efficacy
Solution Approach 2:
The patent uses controlled, partial exposure to chemical agents with multiple washing steps to remove pathogens while minimizing damage to the organic-inorganic composite structure through limited contact time and sequential treatment
3Object-affected harmful factors
If extensive cleaning treatments are applied to remove all organic material, then pathogen removal is maximized, but mechanical strength and osteoconductivity are reduced
Solution Approach 1:
The patent selectively extracts only the harmful components (bone marrow, lipids, cellular material) using targeted enzymes and detergents while leaving the structural collagen and mineral phases intact to maintain mechanical strength
Solution Approach 2:
The patent applies different cleaning agents to different aspects of the tissue structure - using proteases for cellular material, detergents for lipids, and mild oxidizing agents for surface decontamination, thereby achieving thorough cleaning without uniform destruction of the matrix
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 process effectively removes bone marrow, prions, and pathogens while preserving the mineral and collagen structure, resulting in a biocompatible graft with maintained mechanical properties for bone regeneration.
Implementation Method 1
sonication of said biological material sample as a mechanical cleaning treatments
Implementation Method 2
sonication of said biological material sample as a mechanical cleaning treatments
Implementation Method 3
centrifugation and sonication of said biological material sample as a mechanical cleaning treatments
Implementation Method 4
Reacting biological material sample/s treated/obtained according to step bii) into Alkaline solution (pH=10.0-14.0) as a chemical cleaning treatment in combination with centrifugation and sonication of said biological material sample as a mechanical cleaning treatments. v. Reacting biological material sample/s treated/obtained according to step biv) with Oxidating agent as a chemical cleaning treatment
Data Source
Figure 1A~1C
Figure 2A~3
Figure 4~5
AI summary
The present invention deals with a cold-cleaning process for deriving a decellularized bone tissue sample or decellularized osteochondral tissue sample to be used as a medical device, or as a raw material.