Decellularized Tissue Sponge Seals Paravalvular Leaks
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Solution Overview
Problem
Paravalvular leakage in heart valve prostheses, particularly after transcatheter aortic valve implantation (TAVI), leads to serious complications, and existing solutions do not adequately address the sealing of these leaks, especially in weak patients.
Innovation Solution
A method involving the preparation of a sponge-like material from decellularized biological tissue, which is crosslinked at temperatures below 0°C and can be molded into specific shapes, providing a sealing solution that can be applied to heart valve prostheses to reduce paravalvular leakage by expanding and thickening upon rehydration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing sealing solutions are used for paravalvular leakage, then the sealing effect is insufficient, but the complexity of the prosthesis increases and biocompatibility deteriorates
Solution Approach 1:
The patent changes the physical and chemical parameters of the sealing material by crosslinking biological tissue at temperatures below 0°C, transforming it into a moldable suspension that can be applied to the prosthesis. This crosslinking process modifies the tissue properties to achieve better sealing while maintaining biocompatibility
Solution Approach 2:
The patent uses composite material construction by combining crosslinked biological tissue with the prosthesis structure. The sealing material is applied as a coating or layer on the prosthesis surface, creating a composite structure that integrates the benefits of both the mechanical prosthesis and the biocompatible biological tissue
2Object-affected harmful factors
If existing sealing materials are applied to heart valve prostheses, then thromboembolic issues and calcification occur, but the biocompatibility improves
Solution Approach 1:
The patent extracts and removes harmful components from the biological tissue through decellularization, eliminating cells that could cause thromboembolic issues and calcification. Only the beneficial extracellular matrix structure is retained and crosslinked for sealing purposes
Solution Approach 2:
The patent converts potentially harmful biological material into a beneficial sealing agent by treating the tissue to remove harmful elements while preserving the sealing properties. The decellularized and crosslinked tissue becomes a biocompatible material that prevents rather than causes thromboembolic complications
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 sponge-like material effectively seals paravalvular leaks, reducing complications and improving the biocompatibility and durability of the prosthetic valve, while minimizing thromboembolic issues and calcification.
Implementation Method 1
decellularizing the extracellular matrix by means of a decellularizing solution
Implementation Method 2
contacting the solubilized extracellular matrix with a crosslinking agent resulting a moldable tissue suspension
Implementation Method 3
crosslinking the moldable tissue suspension for a time longer than 12 hours at temperatures below 0°C in a mold
Implementation Method 4
optionally stabilized drying the obtained crosslinked material with an optional subsequent hot-pressing in order to reduce the thickness
Implementation Method 5
optional subsequent hot-pressing in order to reduce the thickness
Data Source
Figure 1
Figure 2A~2B
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AI summary
The invention relates to a method for preparing a biological tissue for a medical application, particularly for use in a heart valve prosthesis, wherein the method comprises the steps of: decellularizing the biological tissue by means of a decellularizing solution for obtaining an a cellular extracellular matrix, solubilizing the extracellular matrix of the biological tissue, and crosslinking collagen fibers of the solubilized extracellular matrix.