Biological Tissue Dehydration Using Glycerol and Ethanol
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Solution Overview
Problem
Existing methods for preparing biological tissues for surgical implantation often involve aqueous solutions that lead to tissue shrinkage and susceptibility to microbial contamination, making it difficult to achieve ready-to-use, sterile, and dimensionally stable bioprosthetic devices for dry storage.
Innovation Solution
A non-aqueous treatment method using a combination of glycerol and C1-C3 alcohols, such as ethanol, is applied to biological tissues to remove water and stabilize the tissue, allowing for sterilized containment and rehydration, ensuring the tissue remains in a ready-to-use form with minimal preparation required for implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If aqueous solutions are used to treat biological tissue for storage, then the tissue can be maintained in a hydrated state, but the tissue becomes susceptible to microbial contamination and shrinks in dimension
Solution Approach 1:
The patent changes the fundamental parameter of the storage medium from aqueous (water-based) to non-aqueous (organic solvent-based). This parameter change eliminates water availability for microbial growth while preventing tissue shrinkage through the specific chemical properties of the organic solvents used, thereby resolving the contradiction between microbial resistance and dimensional stability
Solution Approach 2:
The patent creates an inert storage environment by using organic solvents that do not support microbial life. The tissue is stored in a non-aqueous environment that is inherently resistant to microbial contamination, while the specific choice of organic solvents maintains tissue dimensional stability, thus resolving the contradiction
2Reliability
If tissue is dehydrated for dry storage, then microbial contamination is reduced, but the tissue shrinks and cannot be successfully rehydrated
Solution Approach 1:
The patent changes the dehydration approach from complete water removal to partial displacement using organic solvents. The tissue is treated with organic solvents that displace water while maintaining tissue structure and dimensions, enabling successful rehydration without permanent shrinkage, thus resolving the contradiction between microbial resistance and rehydration capability
Solution Approach 2:
The patent uses organic solvents as intermediary substances that facilitate the transition from hydrated to dry storage state without causing permanent tissue damage. These intermediaries allow the tissue to be stored in a microbial-resistant state while preserving the ability to be rehydrated, resolving the contradiction between microbial resistance and rehydration capability
3Object-affected harmful factors
If tissue is extensively rinsed to remove chemical agents, then the tissue is safer for implantation, but the preparation time increases and opportunities for error increase
Solution Approach 1:
The patent employs a disposable sterile barrier (packaging) that eliminates the need for extensive rinsing. The tissue is packaged in a sterile container that prevents contamination, allowing the tissue to be used immediately without time-consuming rinsing steps, thus resolving the contradiction between chemical safety and preparation time
Solution Approach 2:
The patent performs preliminary sterilization and chemical removal steps during the tissue processing and packaging phase, before the tissue reaches the surgical setting. This preliminary action ensures the tissue is safe for implantation without requiring extensive rinsing during surgery, resolving the contradiction between chemical safety and preparation time
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 method effectively maintains the tissue's original dimensions and reduces microbial contamination, providing a sterile, stable, and ready-to-use biological tissue or bioprosthetic device suitable for surgical implantation with minimal rehydration needed, enhancing manufacturing control and reducing the risk of microbial contamination.
Implementation Method 1
contacting the fixed biological tissue with a non-aqueous treatment solution comprising glycerol and a C1-C3 alcohol and removing a portion of the treatment solution
Implementation Method 2
biological tissue that has been fixed by cross-linking the amine groups of the proteins of the tissue with aldehydes
Data Source
AI summary
A method of treating a biological tissue that enables dry storage of said tissue is disclosed. In one embodiment, the method comprises contacting the biological tissue with a non-aqueous treatment solution comprising a polyhydric alcohol and a C1-C3 alcohol and removing a portion of the treatment solution from the solution-treated biological tissue. Also disclosed is biological tissue prepared using the above process and prosthetic devices made with such tissue.