ECM Prosthetic Valve Tissue Regeneration
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Solution Overview
Problem
Conventional prosthetic heart valves face issues such as tissue calcification, requirement for anticoagulation agents causing side effects, and the need for open heart surgery, along with the inability to remodel into normal tissue capable of regeneration and self-repair.
Innovation Solution
Development of prosthetic tissue valves with continuous conical shaped tubular members made from extracellular matrix (ECM) compositions, which include biologically active agents and pharmacological agents to induce host tissue proliferation, bioremodeling, and regeneration, and are designed for secure attachment to cardiovascular structures without the need for cardiopulmonary bypass.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If conventional prosthetic valves are used, then valve replacement can be achieved, but tissue calcification and deterioration occur over time
Solution Approach 1:
The patent changes the material parameters of the prosthetic valve by using glutaraldehyde cross-linked tissue instead of conventional materials, which fundamentally alters the biochemical properties to prevent calcification and deterioration while maintaining structural integrity over time
Solution Approach 2:
The invention creates a composite structure by combining glutaraldehyde cross-linked tissue with a support structure, forming a composite material that exhibits both the biological compatibility of tissue and the mechanical strength needed to resist calcification and wear
2Reliability
If mechanical valves are used, then durable valve replacement is achieved, but anticoagulation agents are required causing side effects
Solution Approach 1:
The patent replaces the mechanical valve system with a bioprosthetic system using glutaraldehyde cross-linked tissue, which eliminates the need for anticoagulation therapy while maintaining reliable valve function through the cross-linked tissue's inherent durability and resistance to degradation
3Adaptability or versatility
If conventional prosthetic valves are used, then valve replacement is achieved, but the valves cannot remodel into normal tissue capable of regeneration
Solution Approach 1:
The invention introduces dynamic properties to the prosthetic valve by using glutaraldehyde cross-linked tissue that can undergo controlled remodeling and adaptation over time, allowing the valve to integrate with host tissue and potentially regenerate while maintaining structural stability through the cross-linked framework
4Reliability
If conventional surgical methods are used, then valve replacement is achieved, but open heart surgery with cardiopulmonary bypass is required
Solution Approach 1:
The patent employs a flexible thin-film structure made of glutaraldehyde cross-linked tissue that can be delivered through minimally invasive approaches, eliminating the need for open heart surgery and cardiopulmonary bypass while ensuring reliable valve replacement through the film's ability to self-seal and conform to the valve annulus
Data Source
Figure 1A~1B
Figure 1C
Figure 1D~1F
AI summary
A prosthetic valve comprising a conical shaped member comprising an extracellular matrix (ECM) composition, the conical shaped member comprising a sheet member having a plurality of slit regions that are configured to open during expansion of the sheet member that is induced by positive fluid flow through the sheet member and close during contraction of the sheet member that is induced by negative fluid flow through the sheet member.