Prosthetic Vascular Valve Frame for Stable Venous Flow Restoration
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Solution Overview
Problem
Current therapies for venous insufficiency, such as vein stripping and laser treatment, are destructive and fail to effectively restore venous flow and valvular competence due to positional instability and anatomic factors, leading to progressive venous dilation and incompetence.
Innovation Solution
A prosthetic vascular valve with a frame design featuring a high aspect ratio and shape-memory material that maintains axial orientation within the vessel, utilizing a frame with stabilizing structures and a membrane that adjusts to dynamic loading conditions, ensuring effective blood flow regulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If vein stripping or laser treatment is performed, then venous insufficiency is treated, but the venous wall is damaged and valvular competence is not restored
Solution Approach 1:
The invention extracts only the valvular function from the venous system by implanting a standalone prosthetic valve device, rather than attempting to repair or reconstruct the damaged native vein and valve. This bypasses the weakened venous wall while restoring blood flow directionality.
Solution Approach 2:
The prosthetic valve acts as an intermediary device between the damaged venous segments, providing the missing valvular competence without requiring the native venous wall to support or regenerate functional tissue. The device mediates blood flow control in a compromised vascular environment.
2Reliability
If a prosthetic valve is implanted, then venous flow is restored, but positional instability occurs leading to treatment failure
Solution Approach 1:
The frame structure incorporates dynamic elements that allow the prosthetic valve to adapt its configuration in response to physiological conditions. The device can flex, expand, or adjust its shape to maintain optimal positioning and functional alignment with the venous anatomy under varying hemodynamic loads.
Solution Approach 2:
The device utilizes materials or structural features that change physical parameters (such as rigidity, shape, or size) in response to environmental conditions within the vein. This enables the prosthetic valve to maintain stable positioning by adapting to changes in venous pressure, diameter, and flow characteristics.
3Stress or pressure
If the vein dilates chronically, then venous pressure increases, but valve coaptation fails leading to progressive incompetence
Solution Approach 1:
The prosthetic valve is designed with geometric parameters that compensate for venous dilation. The valve leaflets or occluding elements are configured to maintain effective coaptation and sealing across a range of venous diameters and pressure conditions, preventing regurgitation even as the vein expands chronically.
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 prosthetic vascular valve maintains contact with the vessel wall under varying hydrostatic loads, restoring venous flow and valvular competence, thereby addressing venous insufficiency and preventing complications like lymphedema and infection.
Implementation Method 1
A prosthetic vascular valve with a frame design featuring a high aspect ratio and shape-memory material that maintains axial orientation within the vessel
Data Source
AI summary
A prosthetic vascular valve includes one or more continuous loops of frame material or one or more strands of material that do not form a continuous loop. The frame includes a plurality of longitudinal portions, wherein a membrane is attached to at least one of the longitudinal portions, and wherein the membrane is configured to open and close. During implantation, the frame engages the inner surface of the vein wall and is biased against the vein wall to remain stationary. In use, blood flows from an upstream end to a downstream end, wherein the membrane mitigates regurgitation of the blood as the blood is conveyed through the subject vein.