ECM Anchored Cardiovascular Valve for Secure Vessel Attachment
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Solution Overview
Problem
Current prosthetic valves face challenges in achieving secure and reliable attachment to cardiovascular vessels, particularly in the delicate venous system, leading to high risks of perivalvular leakage and limited success in replacing defective peripheral venous valves, with conventional polymeric and metal valves causing intimal hyperplasia and harsh biological responses.
Innovation Solution
The development of anchored cardiovascular valves with a support member made from extracellular matrix (ECM) material and biocompatible anchoring mechanisms, such as microneedle or expandable anchoring systems, that transition from a pre-deployment to a post-deployment configuration for secure positioning within cardiovascular vessels, reducing the risk of leakage and promoting tissue regeneration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If conventional polymeric and metal valves are used for valve replacement, then structural strength and durability are improved, but intimal hyperplasia and harsh biological responses occur
Solution Approach 1:
The patent changes the material parameter from conventional polymeric and metal materials to biodegradable materials with specific mechanical properties. The biodegradable material gradually degrades over time, transitioning from providing structural support to being fully resorbed, thereby eliminating long-term foreign body presence that causes intimalhyperplasia while maintaining necessary structural strength during the healing period
Solution Approach 2:
The patent employs composite material construction combining biodegradable polymer matrix with reinforcing elements. This composite structure provides the necessary mechanical strength and durability initially, then gradually degrades as the host tissue heals and takes over the load-bearing function, reducing biological adverse responses
2Reliability
If suturing technique is used to attach prosthetic valve to host tissue, then attachment is achieved, but high risk of perivalvular leakage and dependence on surgeon skill occurs
Solution Approach 1:
The patent replaces the mechanical suturing system with a self-anchoring mechanism. The prosthetic valve incorporates features such as self-expanding frames or adhesive elements that automatically secure the valve to the host tissue upon deployment, eliminating the need for manual suturing and reducing perivalvular leakage risk while making the procedure less dependent on surgeon skill
Solution Approach 2:
The prosthetic valve is designed with self-anchoring capabilities where the device itself performs the attachment function to host tissue. The valve structure includes integrated anchoring elements that engage with the vessel wall automatically during deployment, providing reliable attachment without requiring external suturing assistance
3Reliability
If secured attachment of valve to cardiovascular vessel is achieved, then perivalvular leakage is reduced, but complex anchoring structures may cause additional biological responses
Solution Approach 1:
The patent employs biodegradable anchoring structures that perform their attachment function temporarily during the critical healing period, then gradually degrade and are fully resorbed by the body. These short-lived anchoring elements provide reliable attachment when needed but eliminate long-term foreign body presence that could cause chronic biological responses
Data Source
AI summary
Anchored cardiovascular valves having a support member with at least one leaflet formed therein that is sized and configured to selectively restrict regurgitating blood through the valve, and at least one anchoring mechanism. In a preferred embodiment of the invention, the anchored valves have two anchoring mechanisms, i.e. proximal and distal anchoring mechanisms.