Regenerative Tissue Grafts for Small Diameter Vascular Applications
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Solution Overview
Problem
Current vascular grafts face challenges such as immunogenicity, thrombogenicity, calcification, and limited endothelialization, especially for small diameter grafts, which can lead to post-surgical complications and reduced patency, due to issues with collagen levels, processing methods, and cross-linking techniques.
Innovation Solution
The development of regenerative tissue (RT) matrices processed to reduce calcification, enhance sutureability, flexibility, and compatibility, using fibrinogen, thrombin, and ECM-producing cells to create bioprosthetic materials with customized fiber alignment and decellularization methods, resulting in grafts suitable for small diameters with improved durability and non-thrombogenicity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If small diameter grafts are made from heterologous or synthetic material, then the graft size is reduced for better anatomical fit, but thrombogenicity increases leading to blockage
Solution Approach 1:
The patent applies parameter changes by modifying the chemical composition and surface properties of the graft material through controlled cross-linking processes and biochemical treatments, transforming the material characteristics to reduce thrombogenicity while maintaining small diameter dimensions
Solution Approach 2:
The invention uses composite materials by combining heterologous tissue with synthetic components or coating layers that have anticoagulant properties, creating a multi-layered structure that reduces thrombosis risk in small diameter grafts
2Strength
If glutaraldehyde is used for chemical cross-linking of tissue, then tissue strength is improved, but inflammation risk increases due to glutaraldehyde release
Solution Approach 1:
The patent extracts or removes the harmful glutaraldehyde component from the cross-linking process by using alternative cross-linking agents or methods that do not release inflammatory substances, while still achieving the desired tissue strengthening effect
Solution Approach 2:
The invention introduces an intermediary substance or process that facilitates cross-linking without the harmful effects of glutaraldehyde, such as using enzyme-mediated cross-linking or alternative chemical agents that are biocompatible
3Quantity of substance
If older animals are used as tissue source, then tissue availability is adequate, but collagen levels decrease and non-collagenous protein levels increase reducing graft quality
Solution Approach 1:
The patent replaces the reliance on mechanical selection of young animal tissue with biochemical processing methods that can enhance collagen content and remove non-collagenous proteins from older animal tissue, effectively decoupling tissue quality from animal age
Solution Approach 2:
The invention applies parameter changes by modifying the biochemical composition of the tissue through processing treatments that increase collagen concentration and decrease non-collagenous protein levels, transforming the material properties regardless of source animal age
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 RT matrices provide grafts with enhanced compatibility, flexibility, and durability, reducing thrombosis and calcification, while maintaining strength and resistance to infection, suitable for small diameters, thus improving surgical outcomes and extending the useful life of implants.
Implementation Method 1
combining fibrinogen or the like, thrombin or the like, and matrix-producing cells; and allowing the cells to grow sufficiently to produce extracellular matrix
Implementation Method 2
the limitations of 'wet' cross-linking, when used alone, to bond glutaraldehyde with collagen molecules
Data Source
AI summary
The present invention is an improved implant made from regenerative tissue or natural tissue, methods of making the implant, and methods of using the implant.