Anchored ECM Cardiovascular Valves for Secure Vessel Attachment
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Solution Overview
Problem
Existing prosthetic valves face challenges in achieving secure, reliable, and consistent attachment to cardiovascular vessels, particularly for peripheral venous valves, with limited success in repair and replacement due to spatial constraints and delicate nature of the venous system, and issues like perivalvular leakage and intimal hyperplasia.
Innovation Solution
The development of anchored cardiovascular valves using extracellular matrix (ECM) materials with expandable anchoring mechanisms that temporarily position the valve proximate host tissue, facilitating secure attachment and reducing harsh biological responses, while allowing for tissue regeneration and integration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional prosthetic valves are implanted, then valve replacement is achieved, but secure and reliable attachment to cardiovascular vessels is difficult due to spatial constraints and delicate nature of the venous system
Solution Approach 1:
The prosthetic valve is divided into distinct functional segments: an anchoring mechanism portion that provides secure attachment to the vessel wall, and a valve portion that performs the valve function. This segmentation allows the anchoring mechanism to be optimized independently for reliable attachment while the valve portion handles blood flow control.
Solution Approach 2:
The valve is positioned within an expandable anchoring mechanism that is nested within the vessel. The anchoring mechanism expands outward to engage the vessel wall, creating a secure attachment without requiring extensive surgical exposure or complex suturing techniques.
2Reliability
If expandable anchoring mechanisms are used, then secure attachment is achieved, but device complexity increases
Solution Approach 1:
The anchoring mechanism and valve are combined into a single integrated prosthetic device. The anchoring mechanism portion is directly connected to the valve portion, eliminating the need for separate implantation procedures and reducing overall procedural complexity despite the enhanced attachment capability.
Solution Approach 2:
The anchoring mechanism transitions from a compressed low-profile state during implantation to an expanded high-profile state for secure attachment. This dynamic transformation allows the device to adapt to the implantation process, reducing complexity during insertion while providing robust attachment when deployed.
3Reliability
If conventional valves are implanted, then valve replacement is performed, but perivalvular leakage and intimal hyperplasia occur
Solution Approach 1:
The anchoring mechanism is designed to preemptively seal the interface between the prosthetic valve and the vessel wall, preventing perivalvular leakage before it can occur. The expandable structure creates a tight seal that counteracts potential leakage pathways.
Solution Approach 2:
The anchoring mechanism serves as an intermediary structure between the prosthetic valve and the native vessel wall. This intermediate layer distributes mechanical stresses, reduces friction, and prevents direct contact that would otherwise cause intimalhyperplasia and tissue damage.
4Reliability
If anchored cardiovascular valves with ECM materials are used, then tissue regeneration is promoted, but manufacturing complexity increases
Solution Approach 1:
The prosthetic valve incorporates extracellular matrix (ECM) materials that combine biological functionality with mechanical performance. These composite materials provide a scaffold for tissue regeneration while maintaining the structural integrity required for valve function, though they do present manufacturing challenges.
Data Source
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AI summary
Anchored cardiovascular valves (40) having a support member (10) of remodelable decellularized ECM material with at least one leaflet (30) formed therein that is sized and configured to selectively restrict regurgitating blood through the valve (11, 40, 50, 60, 70), and at least one anchoring mechanism (20A, 20B, 42A, 42B, 52A, 52B, 62A, 62, 65, 67). In a preferred embodiment of the invention, the anchored valves (50) have two anchoring mechanisms (20A, 42A, 52A, 62A), i.e. proximal and distal anchoring mechanisms (20A, 42A, 52A, 62A).