Self-Expanding Venous Valve Prosthesis for Leaflet Coaptation
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Solution Overview
Problem
Current treatments for chronic venous insufficiency, such as venous valve repair and replacement, face challenges due to low blood flow rates, thin and distensible venous walls, and the risk of thrombus formation, leading to ineffective restoration of proper blood flow and increased risk of complications like varicose veins, swelling, and deep vein thrombosis.
Innovation Solution
A self-expanding venous valve repair prosthesis with a tubular body formed from a superelastic or resilient material, featuring anchor and valve apposition portions, is implanted downstream of the malfunctioning valve to reconfigure and support the valve leaflets, improving coaptation and restoring proper blood flow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical reconstruction techniques or percutaneous endoluminal methods are used to repair venous valves, then valve function can be restored, but thrombus formation and valve failure occur due to non-physiologic flow conditions and excessive vessel dilation
Solution Approach 1:
The prosthesis is designed to restore physiologic flow conditions by repositioning valve leaflets to their natural orientation, thereby eliminating non-physiologic flow patterns that cause thrombus formation. The device adjusts geometric parameters of the valve structure to match native anatomy
Solution Approach 2:
The prosthesis employs a flexible, compliant structure that adapts to the natural movement and distension of venous walls during the cardiac cycle, preventing excessive vessel dilation while maintaining valve function and avoiding thrombus formation
2Reliability
If venous valves are repaired or replaced, then blood flow direction can be controlled, but the thin and distensible venous wall structure makes the procedure challenging and prone to complications
Solution Approach 1:
The prosthesis utilizes the natural pressure gradients and flow dynamics of the venous system to achieve self-positioning and stabilization of valve leaflets, eliminating the need for complex surgical anchoring mechanisms or extensive procedural intervention
Solution Approach 2:
The compliant prosthesis structure conforms to the thin, distensible venous wall without requiring rigid fixation or complex deployment mechanisms, simplifying the procedure while maintaining effective blood flow control
3Reliability
If prostheses are implanted to repair venous valves, then valve incompetence can be addressed, but the prostheses cause non-physiologic flow conditions and excessive vessel dilation leading to decreased blood flow rates
Solution Approach 1:
The prosthesis restores physiologic flow parameters by repositioning valve leaflets to their natural orientation and geometry, eliminating non-physiologic flow conditions that cause excessive vessel dilation and reduced blood flow rates
Solution Approach 2:
The prosthesis is designed to dynamically adapt to changing hemodynamic conditions during the cardiac cycle, maintaining optimal blood flow rates by allowing natural venous distension while preventing pathological dilation
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 prosthesis effectively prevents retrograde blood flow, reduces the risk of thrombosis, and enhances venous function, thereby alleviating symptoms of chronic venous insufficiency like swelling and pain, and minimizing the risk of complications like deep vein thrombosis and amputation.
Implementation Method 1
A self-expanding venous valve repair prosthesis with a tubular body formed from a superelastic or resilient material
Implementation Method 2
The prosthesis is configured to repair the venous valve by supporting and reconfiguring the valve leaflets to improve coaptation
Data Source
AI summary
Endovascular prostheses are disclosed that are configured to repair a native venous valve having improper or non-existent valve leaflet coaptation caused by vessel weakness and/or distention. The prostheses are configured to be implanted in the venous system immediately downstream of the malfunctioning valve and act as repair devices to restore proper function to the venous valve by reconfiguring and supporting the valve leaflets and thereby improving their coaptation.