Venous Valve Apparatus with Asymmetric Leaflets for Retrograde Flow Control
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Solution Overview
Problem
Current methods for repairing or replacing venous valves in the body are invasive and not widely successful, leading to chronic venous insufficiency and complications such as swelling and ulcers in the legs due to inefficient blood flow regulation.
Innovation Solution
A minimally invasive valve apparatus with a frame and cover that can be implanted to replace or augment incompetent venous valves, featuring a resilient design with flexible support members and a matrix to maintain antegrade blood flow while reducing retrograde flow, using materials like polymers and ceramics for durability and biocompatibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional valve repair or replacement methods are used, then valve function can be restored, but the procedures are invasive and have limited success rates
Solution Approach 1:
The valve device is divided into distinct functional segments: a delivery catheter for minimally invasive placement, an expandable frame for structural support, and leaflet structures for valve function. This segmentation allows the complex valve replacement to be performed through a minimally invasive catheter-based approach rather than open surgery.
Solution Approach 2:
A delivery catheter serves as an intermediary tool to transport the valve device through the vascular system to the target location. This intermediary enables minimally invasive placement of the valve without requiring direct surgical access to the venous system, thereby reducing procedural invasiveness.
2Reliability
If current valve devices are used, then some blood flow regulation is achieved, but they do not effectively prevent retrograde flow and lead to chronic venous insufficiency
Solution Approach 1:
The valve leaflets are designed with asymmetric geometry where the first leaflet has a different configuration than the second leaflet. This asymmetry creates directional preference in blood flow, allowing antegrade flow through the first leaflet while preventing retrograde flow through the second leaflet, thereby effectively addressing the harmful retrograde flow issue.
Solution Approach 2:
The valve device incorporates dynamic elements including resilient leaflets that can flex with blood flow and an expandable frame that adapts to the venous anatomy. This dynamic design allows the valve to respond to varying blood flow conditions and maintain effective unidirectional flow regulation under different physiological states.
3Ease of operation
If minimally invasive implantation is used, then procedural invasiveness is reduced, but device complexity increases
Solution Approach 1:
The valve device employs a nested configuration where the leaflet structures are positioned within the frame, and the entire valve assembly is contained within the delivery catheter during implantation. This nesting allows complex valve components to be compacted into a small delivery catheter for minimally invasive insertion, then deployed at the target site to form the functional valve structure.
Solution Approach 2:
The frame of the valve device is designed to change its physical parameters during implantation, transitioning from a compressed state within the catheter to an expanded state at the target location. This parameter change enables the device to be delivered through minimally invasive means while achieving the necessary structural complexity for effective valve function at the implant site.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The apparatus effectively regulates blood flow in a single direction, reducing swelling and ulcers by providing a durable and biocompatible solution for venous insufficiency through minimally invasive implantation and self-expansion within the venous system.
Implementation Method 1
a resilient frame and cover that can be implanted through minimally-invasive techniques into a body lumen... the frame and cover can resiliently radially collapse and expand
Data Source
AI summary
A venous valve with a frame and a cover on the frame for unidirectional flow of a liquid through the valve.