ECM Prosthetic Tissue Valve Bioremodeling
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Solution Overview
Problem
Conventional prosthetic heart valves face issues such as tissue calcification, the need for anticoagulation agents causing side effects, and the inability to remodel into normal tissue capable of regeneration, often requiring open heart surgery with a heart-lung machine.
Innovation Solution
Development of prosthetic tissue valves with extracellular matrix (ECM) compositions derived from mammalian tissue sources, incorporating biologically active agents and pharmacological agents to induce host tissue proliferation, bioremodeling, and regeneration, along with secure attachment methods to cardiovascular structures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional prosthetic heart valves are used, then valve replacement can be achieved, but tissue calcification occurs and the valve cannot remodel into normal tissue
Solution Approach 1:
The patent changes the material parameters of the prosthetic valve by using decellularized extracellular matrix (ECM) instead of traditional synthetic or animal tissue materials. This ECM material has specific biochemical and biomechanical properties that enable it to be remodeled by host cells into functional native tissue, thereby achieving both durability and adaptability.
Solution Approach 2:
The patent employs composite construction by combining decellularized ECM material with specific structural designs (such as stent frameworks or annular rings) to create a prosthetic valve that maintains structural integrity while allowing biological remodeling. The composite nature enables both mechanical reliability and biological adaptability.
2Reliability
If mechanical prosthetic valves are used, then valve function is restored, but anticoagulation agents are required causing side effects
Solution Approach 1:
The patent replaces mechanical valve components with biologically active ECM material that functions through biological mechanisms rather than mechanical action. The ECM valve leaflets open and close through tissue remodeling and cellular activity rather than mechanical actuation, eliminating the need for anticoagulation therapy while maintaining reliable valve function.
3Reliability
If traditional surgical methods are used, then valve replacement can be performed, but open heart surgery with heart-lung machine is required
Solution Approach 1:
The patent segments the valve replacement procedure into modular components that can be delivered separately and assembled or deployed in situ. The prosthetic valve is designed as a self-contained unit that can be implanted through less invasive approaches, reducing surgical complexity while maintaining reliable outcomes.
Data Source
AI summary
A prosthetic valve comprising a conical shaped sheet member comprising an extracellular matrix (ECM) composition, the sheet member having a plurality of open slit regions that are disposed uniformly on linear planes that are parallel to the sheet member longitudinal axis, and a proximal annulus engagement end diameter and length ratio in the range of 5:1 to 2:1.


