Venous Valve Apparatus with Self-Expanding Frame
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Solution Overview
Problem
Current methods for replacing venous valves in the peripheral vasculature are invasive and not widely successful, leading to chronic venous insufficiency characterized by swelling and pain in the legs due to inefficient blood return to the heart.
Innovation Solution
A minimally invasive apparatus comprising a self-expanding valve with a frame and leaflets that can be implanted near an incompetent valve, using a biocompatible material to regulate blood flow in one direction and reduce hydrostatic pressure, featuring a flexible joint and anchoring elements for secure fixation within the body lumen.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional valve replacement methods (transposition, transplantation) are used, then valve incompetence can be addressed, but the procedures are invasive and complex
Solution Approach 1:
The valve apparatus is divided into separate functional components: a frame structure for structural support and positioning, and leaflet elements for unidirectional flow control. This segmentation allows each component to be optimized independently and facilitates minimally invasive delivery through the frame's expandable structure.
Solution Approach 2:
The frame acts as an intermediary structure that bridges the gap between the catheter delivery system and the target valve site. It provides a self-expanding mechanism that transitions from a compressed delivery state to an expanded functional state at the incompetent valve location, enabling minimally invasive placement.
2Ease of operation
If minimally invasive techniques are used for valve replacement, then surgical complexity is reduced, but device stability and fixation may be compromised
Solution Approach 1:
The frame incorporates dynamic expansion capabilities, transitioning from a compressed state for delivery to an expanded state for functional operation. This dynamic structure provides self-expanding anchoring against the vessel wall, achieving stable fixation without requiring complex surgical anchoring procedures.
Solution Approach 2:
The frame's physical parameters (diameter, volume) change during deployment through controlled expansion. This parameter transformation enables the device to achieve secure mechanical interlocking with the vessel wall while maintaining a compact profile for minimally invasive delivery.
3Ease of operation
If a self-expanding frame structure is used, then minimally invasive delivery is enabled, but manufacturing complexity increases
Solution Approach 1:
The frame is constructed from segmented elements that can be assembled through standard manufacturing processes. This modular approach simplifies fabrication compared to monolithic self-expanding structures, while still enabling the necessary expansion functionality for minimally invasive deployment.
4Reliability
If valve leaflets are added to the frame structure, then unidirectional flow control is achieved, but device complexity increases
Solution Approach 1:
The leaflet elements are merged with the frame structure through direct attachment, creating an integrated valve apparatus. This combination achieves functional valve capability (unidirectional flow control) while minimizing the number of separate components, thereby reducing overall device complexity.
Data Source
AI summary
A venous valve apparatus, system and method for valve replacement. The valve includes a valve frame, a valve leaflet joined to the valve frame, and a support frame. The valve leaflet includes surfaces defining a reversibly sealable opening for unidirectional flow of a liquid. The support frame meets the valve frame on an axis, where the valve frame and the support frame extend from the axis in an opposing direction. The system further includes a catheter, where the valve can be reversibly joined to the catheter at a location between a proximal end and a distal end of the catheter. The system can be used to deploy the valve from the catheter at a predetermined location.