Decellularized Tissue Sealing for Paravalvular Leak Mitigation
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Solution Overview
Problem
Heart valve prostheses often experience paravalvular leaks due to blood flow between the vascular wall and the implant, which existing methods fail to adequately address.
Innovation Solution
A method involving decellularization of pericardial tissue using strong decellularization agents like sodium dodecyl sulphate, followed by cross-linking with glutaraldehyde, and stabilization with glycerol and polyethylene glycol solutions to enhance swelling capability and mechanical stability, allowing the tissue to be used as a sealing means for paravalvular leaks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional tissue preparation methods are used, then the tissue maintains basic structural integrity, but the tissue lacks sufficient swelling capability to effectively seal paravalvular leaks
Solution Approach 1:
The patent applies parameter changes by modifying the tissue through decellularization (removing cells while preserving extracellular matrix), cross-linking (forming chemical bonds between matrix components), and controlled drying. These parameter changes transform the tissue properties to enable significant swelling capability upon rehydration, allowing the tissue to increase in thickness by 2-5 times to effectively seal paravalvular leaks while maintaining structural integrity
Solution Approach 2:
The patent creates a composite material structure by combining decellularized extracellular matrix with cross-linking agents. This composite approach preserves the natural collagen and elastin framework while adding chemical cross-links that provide both structural stability and controlled porosity, enabling the tissue to swell effectively without losing mechanical strength
2Reliability
If strong decellularization agents are used to remove cells, then the tissue achieves high swelling capability, but the mechanical strength of the tissue may be compromised
Solution Approach 1:
The patent applies preliminary action by performing cross-linking immediately after decellularization, while the extracellular matrix structure is still intact and accessible. This timing allows the cross-linking agents to form stabilizing bonds throughout the matrix before any potential structural degradation occurs, preserving mechanical strength while maintaining swelling capability
Solution Approach 2:
The patent creates a composite structure where the decellularized extracellular matrix is reinforced with cross-linking agents. This composite approach uses the natural collagen and elastin framework for flexibility and swelling, while the added cross-links provide tensile strength and structural stability, resolving the contradiction between swelling capability and mechanical strength
3Length of moving object
If the tissue is dried to enhance swelling capability, then the tissue can be stored and transported easily, but the tissue structure may become unstable
Solution Approach 1:
The patent applies preliminary action by performing cross-linking before the drying step. This ensures that the extracellular matrix structure is chemically stabilized with cross-bonds in place before the drying process begins, preventing structural collapse or degradation during water removal and subsequent storage
Solution Approach 2:
The patent controls the drying parameters to remove water while preserving the cross-linked matrix structure. The controlled drying process, following cross-linking, reduces water content to enable stable storage and transport, while the pre-formed cross-links ensure the structure remains intact and ready for controlled swelling upon rehydration
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 treated tissue significantly increases in thickness upon rehydration, effectively sealing gaps between the heart valve prosthesis and the vascular wall, minimizing leaks and maintaining mechanical and biocompatible properties.
Implementation Method 1
During the course of what is known as the decellularization of the tissue, cell membranes, intracellular proteins, cell nuclei and/or other cell components are preferably removed as fully as possible from the tissue in order to obtain an extracellular matrix that is as pure as possible
Implementation Method 2
the tissue is subjected to cross-linking with a glutaraldehyde-containing solution
Implementation Method 3
the tissue is exposed to a first solution containing glycerol and is exposed to a second solution containing at least one type of polyethylene glycol, wherein the tissue is dried after the shape- and structure-stabilizing step
Implementation Method 4
the tissue significantly increases in thickness upon rehydration, effectively sealing gaps between the heart valve prosthesis and the vascular wall
Data Source
AI summary
A method for preparing tissue, in particular pericardial tissue, in particular for a heart valve prosthesis, the method including: decellularizing the tissue; subjecting the decellularized tissue to a cross-linking solution including glutaraldehyde; subjecting the tissue to a shape- and structure-stabilizing step, in which the tissue is exposed to a first solution containing glycerol and is exposed to a second solution containing polyethylene glycol; and drying the tissue after the shape- and structure-stabilizing step.