Prosthetic Venous Valve Retrograde Flow Control
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing methods for treating venous valve insufficiency face challenges in reducing retrograde fluid flow while promoting remodeling of extracellular matrix materials in prosthetic valves, leading to thrombus formation and compromised valve function.
Innovation Solution
The development of medical devices and methods that allow for initial controlled retrograde fluid flow to facilitate remodeling of ECM materials, followed by reduction of retrograde flow to prevent thrombosis and enhance valve function, using remodelable materials like small intestine submucosa and structural features such as retrograde apertures or occluding devices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If retrograde fluid flow is reduced to prevent thrombus formation, then thrombus formation is minimized, but remodeling of ECM materials is compromised
Solution Approach 1:
The patent applies preliminary action by providing an initial amount of retrograde fluid flow before implantation to pre-remodel the ECM materials. This preliminary remodeling action occurs during the manufacturing or preparation phase, allowing the ECM to be conditioned in advance. After implantation, the retrograde flow is reduced or eliminated to prevent thrombus formation, thus resolving the contradiction by performing the beneficial remodeling action before the harmful thrombus risk becomes critical.
Solution Approach 2:
The patent implements periodic action by providing retrograde fluid flow for a specific initial period to enable remodeling, then reducing or eliminating it to prevent thrombus formation. This time-based periodic control allows the system to benefit from retrograde flow during the remodeling phase while avoiding its harmful effects during the long-term implantation phase, effectively resolving the contradiction between remodeling needs and thrombus prevention.
2Reliability
If retrograde fluid flow is provided to promote remodeling, then ECM material remodeling is enhanced, but thrombus formation increases
Solution Approach 1:
The patent applies preliminary action by concentrating the retrograde fluid flow provision during the initial remodeling phase before implantation or immediately after. This ensures that the ECM materials receive sufficient remodeling stimulus during the critical early period when thrombus risk is managed. After this preliminary remodeling is complete, the retrograde flow is reduced or eliminated, preventing thrombus formation while preserving the remodeling benefits.
Solution Approach 2:
The patent implements periodic action by providing retrograde fluid flow during a specific initial period to enhance remodeling, then reducing or eliminating it to prevent thrombus formation. This time-dependent control strategy allows the system to maximize remodeling during the period when it is most beneficial while minimizing thrombus formation during the period when it becomes problematic.
3Reliability
If retrograde apertures are included in valve structure, then remodeling is facilitated, but retrograde flow control is compromised
Solution Approach 1:
The patent applies preliminary action by using retrograde apertures in the valve structure to facilitate remodeling during the initial phase. The apertures are designed to provide controlled retrograde flow paths that enable ECM remodeling. After remodeling is achieved, the system can rely on the remodeled ECM structure itself to provide flow control, reducing the need for ongoing active control through the apertures.
Solution Approach 2:
The patent implements parameter changes by designing retrograde apertures with specific dimensions and configurations that can be optimized for remodeling. The aperture size, shape, and positioning are carefully controlled parameters that allow sufficient retrograde flow for remodeling while limiting excessive flow that would promote thrombus formation. This parameter optimization resolves the contradiction between facilitating remodeling and maintaining flow control.
Data Source
AI summary
Methods of reducing retrograde fluid flow through a valve within a body vessel are provided. The methods can include the steps of identifying a valve exhibiting an undesirable amount of retrograde fluid flow within a body vessel, such as a venous valve or a heart valve, and providing a means for reducing the retrograde fluid flow. A medical device providing a desired amount of retrograde fluid flow can be modified after permitting the medical device to remain in a body cavity for a remodeling-effective time period. The implanted medical device can be modified by subsequently reducing the amount of retrograde fluid flow permitted across the implanted prosthetic valve within the body vessel.