ECM Prosthetic Valve Secure Attachment
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Solution Overview
Problem
Current prosthetic heart valves, including mechanical, allograft tissue, and xenograft tissue valves, face challenges such as adverse inflammatory responses, blood clot formation, anticoagulation requirements, limited availability, and complications like rejection and calcification, which affect their durability and secure attachment to cardiovascular structures.
Innovation Solution
A method for replacing diseased atrioventricular valves using a prosthetic mammalian tissue valve with an ECM composition and a catheter assembly that includes a portal catheter, anchor insertion device, and valve securing device, allowing for secure attachment and expansion to the valve annulus region, utilizing acellular ECM derived from mammalian tissue and biologically active agents for enhanced integration and regeneration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If mechanical or bioprosthetic valves are used to replace diseased native valves, then valve dysfunction is treated, but adverse inflammatory responses, blood clot formation, and anticoagulation requirements occur
Solution Approach 1:
The patent applies parameter changes by transforming the physical and chemical properties of the valve material through decellularization and extracellular matrix processing. This changes the material from a cellular state that triggers immune responses to an acellular ECM state that is biocompatible and resistant to clot formation, while maintaining the structural parameters needed for valve function
Solution Approach 2:
The patent uses composite materials by combining decellularized extracellular matrix from mammalian tissue sources with specific processing treatments. The resulting composite structure retains the natural ECM architecture while eliminating immunogenic cellular components, creating a material that combines structural integrity with biocompatibility
2Object-affected harmful factors
If allograft tissue valves are used, then blood clot formation is reduced, but rejection and limited availability occur
Solution Approach 1:
The patent applies the extraction principle by removing the cellular components from the tissue valve through decellularization processes. This extracts the immunogenic elements that cause rejection while retaining the extracellular matrix framework that provides structural support and prevents clot formation, effectively separating the beneficial from the harmful components
3Quantity of substance
If conventional tissue valves are used, then availability is improved, but calcification and lack of secure attachment occur
Solution Approach 1:
The patent applies preliminary action by pre-coating the valve stent with extracellular matrix material before implantation. This preliminary coating creates an optimized surface that promotes immediate and secure attachment to the annular tissue, preventing post-implantation complications and ensuring long-term durability
Data Source
AI summary
A percutaneous transseptal surgical implantation method for replacing a defective atrioventricular (AV) valve with a conical shaped prosthetic valve formed from extracellular matrix (ECM) tissue. When the method is employed to replace a native mitral valve, the method positions the prosthetic tissue valve in the mitral valve region, whereby the valve does not obstruct the outflow tract of the aortic valve and prevents the leaflets of the aortic valve from coapting.