Biological Tissue Preparation to Reduce Implant Calcification
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Solution Overview
Problem
Biological tissues used for surgical implants, particularly those treated with glutaraldehyde, are susceptible to calcification, leading to structural instability and device failure, and existing methods do not effectively address this issue while maintaining mechanical integrity and immunogenicity.
Innovation Solution
A method involving soaking the tissue in saline, hydrogen peroxide, PBS with EDTA, a mixture of glycerol, ethanol, and EDTA, followed by drying and sterilization, to reduce calcification and improve mechanical properties.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If biological tissue is treated with glutaraldehyde to improve mechanical strength and immunogenicity, then the tissue strength is improved, but the tissue becomes susceptible to calcification leading to structural instability
Solution Approach 1:
The patent applies preliminary action by treating the biological tissue with EDTA and other agents before implantation to prevent calcification. The method involves soaking the tissue in solutions containing EDTA, glycerol, and ethanol to remove calcium deposits and prevent future calcification, thereby addressing the structural instability issue before the tissue is implanted
Solution Approach 2:
The patent uses EDTA as an intermediary substance that binds to calcium ions, preventing them from depositing on the tissue. The treatment solution acts as a mediator between the tissue and calcium, selectively removing calcium while preserving the tissue structure and glutaraldehyde crosslinks
2Object-affected harmful factors
If biological tissue is treated to remove antigenic properties and improve mechanical performance, then immunogenicity is reduced, but the tissue requires complex chemical treatment procedures
Solution Approach 1:
The patent merges multiple treatment functions into a single comprehensive solution. The treatment solution contains EDTA for calcium removal, glycerol for preservation, and ethanol for sterilization, all combined in one soaking process that simultaneously addresses immunogenicity, mechanical strength, and calcification prevention
Solution Approach 2:
The patent applies parameter changes by controlling the concentration and composition of the treatment solution. The solution contains specific concentrations of EDTA (0.1-10 mM), glycerol (5-50%), and ethanol (5-50%), optimized to achieve the desired balance between removing antigenic properties and maintaining tissue integrity
3Productivity
If biological tissue is prepared for surgical implantation with minimal preparation time, then implantation efficiency is improved, but the tissue may not be adequately treated to prevent calcification and degradation
Solution Approach 1:
The patent applies preliminary action by pre-treating the tissue with calcification-inhibiting solutions before sterilization and storage. This allows the tissue to be ready for rapid implantation while already having protective treatment applied, eliminating the need for lengthy preparation procedures in the operating room
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 significantly reduces calcification by up to 50% and maintains the tissue's mechanical strength, making it ready-to-use for surgical implantation with improved resistance to degradation and biofilm adherence.
Implementation Method 1
contacting the soaked biological tissue with an aqueous solution comprising Hydrogen Peroxide
Implementation Method 2
contacting the biological tissue with an aqueous solution comprising PBS and EDTA
Implementation Method 3
contacting the biological tissue with a solution comprising glycerol, ethanol and EDTA
Data Source
AI summary
The present invention relates to a method for treating biological tissue and a biological tissue obtained by the treatment method, and specifically to a method for treating biological tissue so as to suppress the calcification, risk of biofilm adherent over pericardium and strength reduction of the tissue due to treatment. The invention is also directed to bioprosthesis and transcatheter heart valves containing the biological tissue.