Orthogonal Tricuspid Valve Frame for Regurgitation Control
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Solution Overview
Problem
Existing transcatheter heart valves often suffer from regurgitation issues and require expensive materials engineering to withstand the mechanical stresses of heart function, necessitating a simpler and more effective solution for managing regurgitation.
Innovation Solution
A heart valve regurgitation drum and optional closure component, comprising a first inner flow control component, a second inner regurgitation control component, and an outer annular support frame, allowing for orthogonal delivery and deployment without an oversized catheter, with features like a foldable and compressible frame, tissue cover, and radio-opaque markers, enabling precise control of regurgitation levels.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If traditional transcatheter heart valves are delivered through the aorta, then the valve can be implanted in the aortic position, but the approach does not work for tricuspid valve replacement due to anatomical constraints
Solution Approach 1:
The patent introduces a novel orthogonal delivery approach where the valve is delivered from the right femoral artery through the inferior vena cava to reach the tricuspid valve, rather than using the traditional transaortic approach. This dimensional change in delivery pathway enables treatment of the tricuspid valve without requiring complex surgical intervention or catheter manipulation through tight anatomical spaces.
2Manufacturing precision
If large-diameter valves are delivered through standard catheters, then the valve size is sufficient for proper function, but the catheter becomes oversized and difficult to deliver
Solution Approach 1:
The delivery system is segmented into multiple components: a collapsible valve structure that can be compressed to a small profile for catheter delivery, and an expansion mechanism that activates at the target site. The valve frame is designed with collapsible elements that allow it to be compressed axially and radially, reducing its diameter to fit within standard catheters while maintaining its full functional diameter upon deployment.
Solution Approach 2:
The valve structure transitions from a static large-diameter configuration to a dynamic collapsible configuration during delivery, then expands back to its functional diameter at the implantation site. This dynamic transformation allows the valve to adapt its size requirements at different stages of the procedure, fitting within small catheters during delivery while providing adequate valve diameter for proper hemodynamic function after deployment.
3Reliability
If expensive materials engineering is used to withstand mechanical stress, then the valve durability is improved, but the cost and complexity of the device increases
Solution Approach 1:
The patent changes the fundamental parameters of the valve construction by using a bioprosthetic tissue-based approach rather than traditional mechanical materials. The bioprosthetic valve leaflets are made from biological tissue that naturally withstands the mechanical stresses of heart function through its inherent material properties, eliminating the need for complex expensive materials engineering while maintaining durability and reliability.
4Adaptability or versatility
If the valve is delivered orthogonally from the femoral artery, then access to the tricuspid valve is achieved, but the delivery angle and path are non-traditional
Solution Approach 1:
The patent uses the inferior vena cava as an intermediary pathway to connect the femoral artery access site to the tricuspid valve target. This intermediary route provides a relatively straight and accessible path through the body, avoiding the need for complex catheter manipulation through the aorta and across the aortic valve. The intermediary pathway simplifies the delivery route while enabling access to previously difficult-to-reach valvular positions.
Data Source
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AI summary
The invention relates to an access and occluder device, and in particular a heart valve regurgitation drum and optional closure disk and/or tubular stent to manage and provide levels of intentional regurgitation within a transcatheter heart valve replacement, and in particular, an orthogonally delivered transcatheter prosthetic heart valve having a first inner flow control component/valve, a second inner regurgitation control component, and an outer annular support frame having compressible wire cells that facilitate folding flat along the z-axis and compressing the valve vertically along the y-axis, or orthogonally to the central axis of the flow control component, allowing a very large diameter valve to be delivered and deployed to the tricuspid valve from the inferior vena cava or superior vena cava, or trans-atrrally to the mitral valve, the valve having a height of about 5-60mm and a diameter of about 25-80mm, without requiring an oversized diameter catheter and without requiring delivery and deployment from a catheter at an acute angle of approach.