Microcatheter Balloon Valve Embolic Backflow Prevention

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Solution Overview

Problem

Existing intravascular delivery methods for fluid embolic compositions face challenges in preventing migration and backflow of embolic materials from the desired embolization site, leading to undesired occlusions in the vasculature during treatments like AVM and aneurysm procedures.

Innovation Solution

A microcatheter system with an inflatable balloon and a valve mechanism that isolates the embolization site, minimizing the entry of embolic fluids into the catheter lumen post-delivery, and featuring a passive or active valve to maintain a seal, ensuring the embolic composition remains at the target site and prevents backflow.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the liquid embolic composition is delivered to the embolization site, then the treatment of AVM or aneurysm is achieved, but the embolic composition may migrate away from the embolization site and occlude undesired locations in the vasculature

Engineering Contradiction:
Improveprecision of embolic composition deliveryVSAvoidmigration of embolic composition to undesired locations
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The inflatable balloon is positioned and inflated at the embolization site before delivering the liquid embolic composition. This preliminary action creates a containment barrier that prevents the embolic composition from migrating away from the target site, ensuring it remains confined to the desired location during and after delivery.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The inflatable balloon acts as an intermediary barrier between the delivery catheter and the vasculature. It temporarily isolates the embolization site, allowing controlled delivery of the embolic composition while preventing its unwanted migration into surrounding vascular structures.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If the liquid embolic composition is delivered to the embolization site, then the treatment effect is achieved, but backflow or reflux of the embolic composition into the vasculature may occur

Engineering Contradiction:
Improveprecision of embolic composition deliveryVSAvoidbackflow of embolic composition into vasculature
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The inflatable balloon is inflated at the embolization site before embolic composition delivery to establish a containment barrier. This preliminary containment prevents backflow by blocking the reverse path into the vasculature, ensuring unidirectional flow of the embolic material into the target site.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The inflated balloon serves as an intermediary barrier that physically blocks the backflow path. It separates the delivery system from the circulatory system, preventing embolic composition from refluxing into the vasculature while allowing controlled delivery to the embolization site.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If a valve is used to seal about the inner member, then backflow prevention is improved, but device complexity increases

Engineering Contradiction:
Improvebackflow preventionVSAvoidvalve mechanism within catheter
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The valve is configured to automatically seal about the inner member through its own structural design, such as resilient flaps that close passively or hydrogel that hardens in response to blood presence. This self-actuating mechanism eliminates the need for complex external control systems, providing backflow prevention while minimizing added device complexity.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The passive valve mechanism replaces complex active mechanical control systems. Instead of requiring motors, sensors, or complex actuation mechanisms, the valve uses passive physical principles such as elastic recovery of resilient flaps or chemical hardening of hydrogel to achieve sealing and backflow prevention automatically.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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

Effectively contains the embolic composition at the desired site, reducing the risk of unwanted occlusions and ensuring precise delivery, thereby enhancing the efficacy of vascular treatments by maintaining the embolic material within the intended location.

Implementation Method 1

The inflatable balloon is in fluid communication with the first longitudinal lumen of the outer member via one or more inflation holes defined by the outer member, and is adapted to inflate upon passage of inflation fluids through the first longitudinal lumen

Methodology Applied
Scientific EffectFluid pressure: Pressure Increase

Implementation Method 2

The valve is dimensioned to establish a substantial seal about the inner member, to thereby minimize entry of the embolic fluids within the first longitudinal lumen of the outer member subsequent to delivery of the fluids toward the embolization site

Methodology Applied
Scientific EffectSealing:

Implementation Method 3

Upon delivery, a biocompatible solvent of the composition dissipates into the blood, fluid, or tissue, and a water insoluble polymer of the composition precipitates to form a coherent mass, which solidifies in vivo

Methodology Applied
Scientific EffectPrecipitation: Precipitation

Data Source

PatentEP2695637B1Apparatus and system for delivering an embolic composition
Publication Date: 2020.03.04 COVIDIEN LP
  • EP2695637B1 patent drawingFigure 1
  • EP2695637B1 patent drawingFigure 2
  • EP2695637B1 patent drawingFigure 3A~7B

AI summary

A microcatheter (100) for delivery of embolic fluids includes an outer member (102) dimensioned for insertion within a blood vessel adjacent an embolization site. The outer member defines a first longitudinal lumen (120), and an inner member (104) is selectively positionable within the first longitudinal lumen of the outer member. The inner member defines a second longitudinal lumen (132) and has a delivery port (176) in fluid communication with the second longitudinal lumen for passage and delivery of embolic fluids toward the embolization site. A valve (140) is disposed within the outer member. The valve is dimensioned to establish a substantial seal about the inner member, to minimize entry of the embolic fluids within the first longitudinal lumen of the outer member subsequent to delivery thereof toward the embolization site.