Expandable ECM Sealing Member for Perivalvular Leak Closure
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Solution Overview
Problem
Perivalvular leaks often occur during or after cardiovascular valve replacement due to calcified native valve leaflets, leading to gaps between the replacement valve and the vessel, which existing suturing methods struggle to reliably seal, especially depending on surgical skill.
Innovation Solution
A biocompatible, expandable member, such as a shape memory alloy or bioremodelable extracellular matrix material, is used to transition from a pre-deployment to a post-deployment configuration, establishing intimate contact with host cardiovascular tissue to seal leaks, potentially incorporating biologically active agents and support members like microneedles for enhanced sealing and tissue regeneration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If suturing methods are used to attach the valve to the annulus, then the valve can be secured to the cardiovascular vessel, but perivalvular leaks occur due to calcified native valve leaflets creating gaps between the replacement valve and the vessel
Solution Approach 1:
A sealing member is introduced as an intermediary component between the replacement valve and the host cardiovascular tissue. This sealing member specifically addresses the gap problem caused by calcified native valve leaflets by providing a compliant barrier that conforms to the irregular annulus geometry, thereby sealing perivalvular leaks without requiring perfect surgical suturing technique
Solution Approach 2:
The sealing member utilizes shape memory alloy material that changes its physical parameters (shape and size) in response to temperature changes. The member is deployed in a compressed state at lower temperature and then transitions to an expanded conforming state at body temperature, enabling it to adapt to the irregular annulus geometry and seal gaps created by calcified leaflets
2Reliability
If the sealing member is made highly compliant to conform to irregular annulus geometry, then sealing effectiveness improves, but the structural support and positioning stability may be compromised
Solution Approach 1:
The sealing member is constructed from shape memory alloy material that combines the compliance needed to conform to irregular annulus geometry with the structural strength required for positioning stability. The shape memory alloy provides both the elastic deformation capability for sealing and the mechanical strength to maintain position against blood flow forces
Solution Approach 2:
The sealing member transitions from a rigid, easily positionable state during deployment to a compliant, conforming state after deployment. The shape memory effect allows the member to dynamically change its mechanical properties, providing structural support during insertion and positioning, then transitioning to high compliance for sealing against the irregular annulus
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 solution effectively seals perivalvular leaks, promotes tissue regeneration, and reduces the reliance on surgical skill, providing a reliable and efficient method for sealing leaks post-valve replacement.
Implementation Method 1
a biocompatible shape memory alloy member that is capable of transitioning from a pre-deployment configuration at a first temperature to a post-deployment configuration when the expandable member is disposed proximate the cardiovascular tissue and subjected to the first tissue temperature
Data Source
AI summary
An expandable support member comprising an ECM composition that is configured to engage an interior region of a prosthetic valve and capable of transitioning from a pre-deployment configuration, where the support member is capable of being positioned at an interior valve region of the valve when the valve is disposed at a cardiovascular valve structure, to a post-deployment configuration when the support member absorbs a first bodily fluid and expands, where an outer surface region of the valve is placed in intimate contact with host cardiovascular tissue of the cardiovascular structure at a first position and seals perivalvular leaks present at the first cardiovascular structure position.