Dry Tissue Preparation Without Alcohol Rinses or Calcification
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Solution Overview
Problem
Existing treatments for animal tissues used in prosthetic heart valve leaflets, such as glutaraldehyde fixation, lead to tissue-fatigue and calcification, reducing their longevity and durability.
Innovation Solution
A method involving tissue treatment with a fixation solution, bioburden reduction, anti-calcification, dimensional stabilization, and application of a thickening agent followed by alcohol removal and sterilization, without using alcohol-based rinses, to enhance tissue properties and stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If alcohol-based rinses are used to remove dimensional stabilization solution from tissue, then the dimensional stabilization solution is removed from the tissue, but the tissue becomes dehydrated and potentially damaged
Solution Approach 1:
A thickening agent is introduced as an intermediary substance to facilitate the removal of dimensional stabilization solution from tissue. The thickening agent is applied to the tissue surface, allowed to penetrate and interact with the dimensional stabilization solution, then mechanically removed along with the dimensional stabilization solution. This intermediary approach enables solution removal without direct contact between alcohol and tissue, preventing dehydration and damage while achieving the desired cleaning effect.
2Stability of the object's composition
If glutaraldehyde fixation is used to stabilize tissue structure, then tissue stability is improved, but tissue-fatigue and calcification occur reducing longevity
Solution Approach 1:
The invention modifies the chemical parameters of tissue fixation by replacing traditional glutaraldehyde-based crosslinking agents with alternative compounds that provide similar structural stabilization without the harmful side effects. This parameter change in the chemical composition of the fixation solution allows the tissue to maintain its structural integrity and stability while preventing the development of tissue-fatigue and calcification, thereby extending the functional longevity of the tissue in implantable devices.
3Quantity of substance
If alcohol rinses are used to remove dimensional stabilizer, then the dimensional stabilizer is removed, but the tissue is dehydrated and damaged
Solution Approach 1:
The thickening agent serves as a mediator that interacts with the dimensional stabilizer on the tissue surface. When applied, the thickening agent binds to or absorbs the dimensional stabilizer, forming a composite substance that can be mechanically removed. This intermediary mechanism achieves complete removal of the dimensional stabilizer without requiring direct application of alcohol rinses to the tissue, thereby eliminating the harmful dehydration effect while maintaining the desired removal outcome.
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 improves tissue durability, reduces calcification, and enhances biocompatibility, resulting in reduced heterogeneity and improved mechanical properties compared to prior art processes.
Implementation Method 1
applying a thickening agent to exposed surfaces of the animal tissue component to remove residual dimensional stabilizer solution that remains on the animal tissue component
Implementation Method 2
treating the animal tissue component with a dimensional stabilizer solution for a time sufficient to equilibrate within the interstices of the animal tissue component
Data Source
AI summary
A method of preparing tissue components includes a) providing tissue, b) optionally cleaning the tissue, c) exposing the tissue to a fixation solution, d) optionally exposing the tissue to a bioburden reduction solution, e) optionally exposing the tissue to an anti-calcification solution, f) exposing the tissue to a dimensional stabilizer solution, g) applying a thickening agent or alcohol to the tissue, h) optionally removing the thickening agent or alcohol from the tissue, i) optionally storing the treated tissue in a packaging or a container that is absent a liquid solution, and j) subjecting the packaged, container and/or tissue to a sterilization process.