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

VSEngineering 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

Engineering Contradiction:
Improvetargeted delivery accuracyVSAvoidcatheter structure
Core Design Contradiction:
ReliabilityVSDevice complexity

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

Inventive Principle:
Principle #7Nested doll (Nesting)

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

Inventive Principle:
Principle #15Dynamics

2Reliability

If the valve structure is expanded to prevent reflux, then embolic agent backflow is blocked, but forward blood flow may be restricted

Engineering Contradiction:
Improvereflux preventionVSAvoidforward blood flow
Core Design Contradiction:
ReliabilityVSProductivity

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

Inventive Principle:
Principle #15Dynamics

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

Inventive Principle:
Principle #3Local quality

3Reliability

If the valve is deployed to block reflux, then embolic agents are contained, but the device cannot be easily retrieved or repositioned

Engineering Contradiction:
Improveembolic agent containmentVSAvoiddevice retrieval
Core Design Contradiction:
ReliabilityVSEase of repair

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

Inventive Principle:
Principle #15Dynamics

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

Inventive Principle:
Principle #10Preliminary action

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

Methodology Applied
Scientific EffectElastic recovery: Elastic Recovery

Implementation Method 2

a filter to trap embolic agents, allowing contrast and blood to pass while blocking embolic agents

Methodology Applied
Scientific EffectPhysical filtration: Filter (physical)

Data Source

PatentEP2506800B1Microvalve protection device
Publication Date: 2020.01.22 TRISALUS LIFE SCIENCES INC
  • EP2506800B1 patent drawingFigure 1
  • EP2506800B1 patent drawingFigure 2A~2C
  • EP2506800B1 patent drawingFigure 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.