Braided Valve System for Embolization Reflux Control
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Solution Overview
Problem
Embolization therapies face challenges with reflux of embolization agents during procedures, leading to non-targeted delivery and adverse effects on healthy organs due to rapid and unpredictable reflux phenomena, which existing methods struggle to control effectively.
Innovation Solution
A deployable valve system integrated with a catheter, featuring braided filaments with a spring bias that expands to prevent reflux by assuming a frustoconical shape, allowing forward blood flow while trapping embolization agents, and is deployable via various mechanisms such as an outer sleeve or guidewire.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a catheter is used to deliver embolization agents, then the agents can be delivered to the target vessel, but reflux of the agents occurs and causes non-targeted delivery
Solution Approach 1:
A filter device is introduced as an intermediary component between the catheter and the target vessel. The filter has a distal end that contacts the vessel wall and a proximal end that receives embolization agents from the catheter. The filter structure with its specific pore size acts as a mediator that allows controlled passage of agents to the target while preventing reflux into collateral vessels, thus solving the non-targeted delivery problem.
Solution Approach 2:
The filter device utilizes porous material structure with specifically controlled pore sizes. The porous structure allows embolization agents to pass through to the target vessel while the pore size is designed to prevent larger agents or clots from causing non-targeted embolization. This porous material approach enables selective filtration based on particle size, resolving the contradiction between effective drug delivery and prevention of harmful reflux.
2Productivity
If the embolization procedure is performed rapidly, then productivity is improved, but reflux occurs more frequently and is harder to control
Solution Approach 1:
The filter device is deployed in advance before embolization agent injection begins. The filter is positioned and secured against the vessel wall prior to the rapid injection of agents. This preliminary placement ensures that when rapid injection occurs, the filter is already in position to prevent reflux, allowing high productivity without sacrificing reliability of reflux control.
Solution Approach 2:
The filter acts as a buffer intermediary between the rapid injection flow and the vessel system. During rapid injection, the filter absorbs and redistributes the flow dynamics, preventing sudden pressure changes that cause reflux. This intermediary function allows rapid procedure execution while maintaining reliable control over agent distribution.
3Manufacturing precision
If a filter device is added to prevent reflux, then targeted delivery is improved, but device complexity increases
Solution Approach 1:
The filter device is merged with the catheter system as an integrated assembly. The filter is attached to the catheter tip or delivered through the catheter, combining two functions (delivery and filtration) into a single integrated device. This merging reduces the number of separate components that need to be manipulated independently, thereby improving targeted delivery precision without proportionally increasing operational complexity.
Solution Approach 2:
The filter device is designed with multi-functionality: it serves as both a delivery conduit for embolization agents and a reflux prevention mechanism. The same structure that delivers agents also filters and directs flow to prevent non-targeted delivery. This universality means one component performs multiple functions, improving precision without adding separate dedicated components for each function.
4Object-affected harmful factors
If the filter pore size is reduced to prevent reflux, then harmful factors are reduced, but forward flow of blood and contrast agents may be impeded
Solution Approach 1:
The filter structure is designed with spatially varying properties: the distal end that contacts the vessel wall has a different pore structure compared to the proximal end that receives agents. The local quality of the pore size and structure is optimized for different functions - tighter filtration where needed and more open structure where flow must pass, preventing non-targeted embolization while maintaining adequate forward flow of blood and contrast agents.
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 valve system significantly reduces or stops reflux of embolization agents, ensuring targeted delivery and minimizing adverse effects on non-target organs by adapting to local flow conditions, allowing blood and contrast agents to pass while capturing embolic agents.
Implementation Method 1
featuring braided filaments with a spring bias that expands to prevent reflux by assuming a frustoconical shape
Implementation Method 2
the valve includes a plurality of filaments which cross over each other (i.e., are braided) and which have a spring bias to assume a preferred crossing angle relative to each other
Implementation Method 3
The valve is adapted to reduce or stop the reflux of the embolization agents while allowing forward flow of blood and contrast agents past the valve
Data Source
AI summary
An apparatus is provided that is useful in an embolization procedure and enables substantially unrestricted forward flow of blood in a vessel and reduces or stops reflux (regurgitation or backward flow) of embolization agents which are introduced into the blood. A method of using the apparatus is also provided.