Bioprosthetic Tissue Treatment with Cyclodextrin and Ethanol
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Solution Overview
Problem
Bioprosthetic heart valves derived from Glutaraldehyde-pretreated bovine or porcine tissues are prone to calcification due to the chemical cross-linking process, which leads to dystrophic calcification and immunologic rejection, and existing treatments have not effectively prevented long-term calcification.
Innovation Solution
A combined treatment using Cyclodextrins and Ethanol is applied to bioprosthetic tissues, where Cyclodextrins extract and complex phospholipids, and Ethanol removes cholesterol and phospholipids, thereby inhibiting calcification and enhancing tissue durability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If Glutaraldehyde cross-link treatment is applied to stabilize biological tissues, then mechanical properties and durability are improved, but dystrophic calcification and immunologic rejection are promoted
Solution Approach 1:
The patent applies ethanol treatment to extract lipids (cholesterol and phospholipids) from the biological tissue before Glutaraldehyde cross-linking. This extraction step removes the harmful lipids that would otherwise promote calcification, while the subsequent cross-linking maintains mechanical strength. The separation of these functions resolves the contradiction between strength and calcification prevention.
Solution Approach 2:
The patent performs lipid extraction using ethanol as a preliminary step before applying the Glutaraldehyde cross-link treatment. By removing lipids in advance, the subsequent cross-linking process can proceed without promoting calcification, as the harmful substrates are already removed. This sequential approach allows both mechanical stabilization and calcification prevention to be achieved.
2Strength
If Glutaraldehyde cross-link treatment is applied to stabilize biological tissues, then mechanical properties and durability are improved, but immunologic rejection is promoted
Solution Approach 1:
The patent uses ethanol treatment to extract lipids from the biological tissue before Glutaraldehyde cross-linking. This lipid extraction reduces immunologic rejection by removing lipid components that trigger immune responses, while the cross-linking process maintains the mechanical strength and durability of the tissue.
Solution Approach 2:
The patent performs lipid extraction as a preliminary step before cross-linking. By removing lipids in advance, the subsequent Glutaraldehyde treatment can stabilize the tissue structure without causing immunologic rejection, as the harmful lipid substrates are already removed.
3Object-generated harmful factors
If lipid extraction is performed to prevent calcification, then calcification is reduced, but mechanical stability may be compromised
Solution Approach 1:
The patent performs lipid extraction using ethanol as a preliminary step before applying Glutaraldehyde cross-linking. This sequence ensures that lipids are removed before the cross-linking process, preventing calcification while the subsequent cross-linking maintains mechanical stability. The preliminary action of lipid removal does not compromise stability because the cross-linking step reinforces the tissue structure.
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 treatment significantly reduces calcification in bioprosthetic tissues, improving their mechanical properties and longevity by preventing lipid and protein accumulation, thus extending the durability of bioprosthetic heart valves.
Implementation Method 1
Cyclodextrins are cyclic natural oligosaccharides... assume a toroidal type tridimensional rigid structure, with an external surface containing CH2OH groups and an internal cavity with hydrophobic characteristics... confers to Cyclodextrins the ability of complexation in aqueous solutions
Implementation Method 2
an internal cavity with hydrophobic characteristics... host hydrophobic molecules inside the cavity
Implementation Method 3
Ethanol has been used... for the treatment of bioprosthetic tissues... with the aim to mitigate the process of dystrophic calcification
Implementation Method 4
the biological tissues are chemically stabilized by means of a chemical reaction called 'cross-link' aimed at bonding the collagen and elastin fibers together and stabilizing the extracellular matrix
Implementation Method 5
The mechanism of this type of pathologic calcification is incompletely understood. In animal models, it has been shown that initial calcium nucleation sites are cell membranes, the nucleus, and intracellular organelles, such as the mitochondria of devitalized cells
Data Source
AI summary
The invention concerns the treatment of bioprosthetic tissues a Cyclodextrin, preferably in association with Ethanol.