Braided Valve System for Embolic Agent Reflux Control
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Solution Overview
Problem
Embolization therapies face challenges with reflux of embolic agents during procedures, leading to non-targeted delivery and adverse events due to rapid backflow, which existing technologies struggle to control effectively.
Innovation Solution
A deployable valve system integrated with a catheter that expands to prevent reflux by maintaining unrestricted forward flow, utilizing a braided structure with a spring bias to open fully when blood flow stagnates, and a filter to trap embolic agents, allowing contrast and blood to pass while blocking embolic agents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional catheter is used to deliver embolization agents, then the procedure is simple and minimally invasive, but reflux of embolic agents occurs leading to non-targeted delivery and adverse events
Solution Approach 1:
The valve device is nested within the catheter in a compressed state during delivery, then deployed at the target site. The valve comprises an inner tube surrounded by a braid structure, with the braid initially compressed within the inner tube and then expanded outward to engage the vessel wall, creating a nested configuration that enables reflux prevention while maintaining delivery simplicity
Solution Approach 2:
The valve transitions from a static compressed state during delivery to a dynamic expanded state at the treatment site. The braid structure can dynamically adjust its configuration based on blood flow conditions, expanding when flow reverses to prevent reflux and allowing forward flow when blood moves in the intended direction
2Reliability
If the valve structure is expanded to prevent reflux, then embolic agent backflow is blocked, but forward blood flow may be restricted
Solution Approach 1:
The valve structure dynamically responds to blood flow direction by changing its configuration. During forward flow, the braid remains compressed within the inner tube, allowing unrestricted blood flow. When reflux occurs, the pressure differential causes the braid to expand outward, blocking the reflux path while maintaining forward flow capability
Solution Approach 2:
The valve creates different flow characteristics at different locations and times. The inner tube provides a smooth conduit for forward flow, while the expandable braid creates a blocking structure for reflux. The system locally adapts its properties based on flow direction, maintaining high productivity during forward flow while achieving reliable reflux prevention
3Reliability
If the valve is deployed to block reflux, then embolic agents are contained, but the device cannot be easily retrieved or repositioned
Solution Approach 1:
The valve employs reversible dynamic transformation between compressed and expanded states. A retrieval wire can be passed through the inner tube to compress the braid back into the inner tube, collapsing the valve structure and enabling it to be withdrawn through the catheter. This dynamic reversibility allows the device to switch between containment mode and retrieval mode
Solution Approach 2:
The retrieval wire is positioned and ready before reflux occurs or before the need for retrieval arises. The wire can be quickly advanced to compress and collapse the valve structure, preparing it for retrieval. This preliminary positioning enables rapid transition from deployed to retrievable state when needed
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 embolic agents, ensuring targeted delivery and minimizing adverse effects on healthy tissues by adapting to dynamic blood flow conditions and allowing visualization with contrast agents.
Implementation Method 1
the valve is composed of a braided, elastic material that is spring biased to an open configuration
Implementation Method 2
a filter to trap embolic agents, allowing contrast and blood to pass while blocking embolic agents
Data Source
Figure 1
Figure 2A~2C
Figure 3A~3B
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.