Dynamic Microvalve Reflux Prevention in Endovascular Therapy
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Solution Overview
Problem
Current embolization therapies face challenges with non-targeted delivery of therapeutic agents due to reflux, leading to adverse events and reduced efficacy, as existing microvalve systems have limitations in trackability and reliability, particularly in tortuous vasculature, and may result in incomplete dosing and increased treatment time.
Innovation Solution
A microvalve device with a dynamically adjustable filter valve, formed from naturally spring-biased filamentary construction, which radially expands to prevent reflux and facilitate forward flow, featuring a closed distal portion and separate radial expansion forces at the proximal and distal ends, allowing manual configuration between open and closed states for optimal trackability and deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a microvalve device is used to prevent reflux of therapeutic agents, then non-targeted embolization is reduced, but the device complexity increases
Solution Approach 1:
The microvalve device is nested within the delivery catheter system, with the filter valve contained within a delivery catheter that is itself contained within an outer catheter. This nested configuration allows the complex microvalve functionality to be delivered through standard catheter access routes without proportionally increasing the overall system complexity.
Solution Approach 2:
The filter valve is designed to be dynamically adjustable between open and closed configurations through manual displacement of the inner catheter relative to the outer catheter. This dynamic capability allows the valve to adapt to different procedural needs, providing reflux prevention when required while maintaining forward flow when the valve is in the open position.
2Ease of operation
If the filter valve is designed with separate radial expansion forces at proximal and distal ends, then trackability in tortuous vasculature is improved, but the manufacturing precision requirements increase
Solution Approach 1:
The filter valve incorporates different radial expansion forces at its proximal and distal ends, with the distal portion having reduced radial expansion force to enhance trackability in tortuous vasculature. This local differentiation of mechanical properties allows the valve to navigate complex vascular pathways while maintaining the ability to expand sufficiently for its filtering function.
3Productivity
If the filter valve prevents reflux completely, then therapeutic agent delivery efficiency is improved, but forward flow may be restricted
Solution Approach 1:
The filter valve can be manually displaced between open and closed configurations. When open, it allows unrestricted forward flow of blood and therapeutic agents. When closed, it prevents reflux of therapeutic agents while maintaining forward flow capability. This dynamic adjustability resolves the contradiction between preventing reflux and maintaining forward flow.
4Reliability
If the device is made with a closed distal portion, then reliability in preventing reflux is improved, but the device complexity increases
Solution Approach 1:
The closed distal portion of the filter valve is nested within the delivery catheter system, allowing the reliable reflux prevention mechanism to be integrated within the existing catheter architecture rather than requiring a completely separate complex device.
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 device effectively prevents reflux of therapeutic agents, ensures complete dosing by maintaining forward flow, and enhances trackability and reliability in tortuous vasculature, reducing adverse events and treatment time.
Implementation Method 1
The filter valve is formed from a naturally spring-biased filamentary construction that is biased to radially expand
Data Source
AI summary
An endovascular microvalve device for use in a vessel during a therapy procedure includes an outer catheter, an inner catheter displaceable within the outer catheter, and a filter valve coupled to the distal ends of the inner and outer catheters. The valve is constructed of a braid of elongate first filaments coupled together at their proximal ends in a manner that the first filaments are movable relative to each other along their lengths. A filter is provided to the braid formed by electrostatically depositing or spinning polymeric second filaments onto the braided first filaments. The lumen of the inner catheter delivers a therapeutic agent beyond the valve. The device is used to provide a therapy in which a therapeutic agent is infused into an organ.