ECM Prosthetic Tissue Valves for Calcification Resistance
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Solution Overview
Problem
Conventional prosthetic heart valves face issues such as tissue calcification, the need for anticoagulation therapy with 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, which can be securely attached to cardiovascular structures using annular and conical shaped structural members.
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 over time
Solution Approach 1:
The patent changes the material parameters of the prosthetic valve by using glutaraldehyde cross-linked tissue, which modifies the chemical and physical properties of the valve tissue to resist calcification and improve durability while maintaining biocompatibility
Solution Approach 2:
The patent employs composite construction by combining prosthetic valve tissue with glutaraldehyde cross-linking agent, creating a composite material structure that enhances resistance to calcification while maintaining the necessary mechanical properties for valve function
2Reliability
If mechanical prosthetic valves are used, then valve function is restored, but anticoagulation therapy is required with side effects
Solution Approach 1:
The patent replaces mechanical prosthetic valves with bioprosthetic alternatives made from treated tissue, eliminating the need for mechanical components that require anticoagulation therapy, thereby removing the associated side effects while maintaining valve function
Solution Approach 2:
The patent modifies the biological parameters of the prosthetic tissue through glutaraldehyde treatment to achieve durability comparable to mechanical valves without requiring anticoagulation, changing the material properties to resist degradation and thrombosis
3Reliability
If conventional prosthetic valves are used, then valve replacement is achieved, but the valves cannot remodel into normal tissue
Solution Approach 1:
The patent applies preliminary treatment to the prosthetic tissue using glutaraldehyde cross-linking before implantation, which prepares the tissue to resist calcification and degradation over time, ensuring long-term longevity while maintaining the ability to integrate with host tissue
Solution Approach 2:
The patent uses glutaraldehyde as an intermediary substance that facilitates the integration between the prosthetic valve and host tissue, enabling the prosthetic material to serve as a scaffold that can be gradually replaced or integrated with native tissue structures
4Ease of manufacture
If open heart surgery with heart-lung machine is used, then valve replacement can be performed, but surgical complexity and risk increase
Solution Approach 1:
The patent modifies the implantation parameters by designing a prosthetic valve that can be deployed with simplified techniques, potentially avoiding the need for cardiopulmonary bypass, thereby reducing surgical complexity and associated risks while maintaining effective valve replacement
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 ribbons projecting the sheet member proximal end, the distal ends of the ribbons being positioned proximate each other, wherein the sheet member comprises a conical shape.