Dynamic Microvalve for Embolization Reflux Protection

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Solution Overview

Problem

Current embolization therapies face challenges with non-targeted delivery of treatment agents due to reflux, leading to adverse events and reduced efficacy, particularly in hypervascular tumors or chemotherapy-resistant patients, where slow flow limits therapeutic agent delivery and reflux occurs rapidly or momentarily, causing damage to surrounding healthy organs.

Innovation Solution

A deployable apparatus with a valve mechanism is used in the catheter to ensure substantially unrestricted forward flow and prevent reflux of embolization agents by deploying a braid-like valve that expands to seal against the vessel wall when pressure conditions allow, using filaments with a spring bias and rapid response to pressure changes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Length of moving object

If a microcatheter is used to infuse embolic agents, then the treatment can be delivered to distal vasculature, but reflux of the embolic agent occurs backward into non-target vessels causing non-target damage

Engineering Contradiction:

Improvedistal penetration of therapeutic agentVSAvoidnon-target damage from reflux

Core Design Contradiction:

Length of moving objectVSObject-affected harmful factors

Solution Approach 1:

A valve is introduced as an intermediary device between the catheter and the vasculature. The valve selectively permits forward flow of embolic agents toward the target while blocking backward reflux into non-target vessels, thus mediating the flow control to prevent harmful effects while maintaining treatment delivery capability

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The valve is designed to be dynamically responsive to pressure changes in the vasculature. It automatically opens to allow forward flow when pressure conditions are favorable and closes to prevent reflux when pressure reversals occur, providing adaptive flow control without external intervention

Inventive Principle:

Principle #15Dynamics

2Productivity

If infusion pressure is increased to overcome slow flow in hypervascular tumors, then therapeutic agent delivery is improved, but reflux of embolic agent occurs more readily into non-target vessels

Engineering Contradiction:

Improvetherapeutic agent delivery rateVSAvoidreflux into non-target vessels

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The valve serves as a protective intermediary that decouples the relationship between infusion pressure and reflux prevention. High infusion pressures can be applied to overcome slow flow and deliver adequate therapeutic doses, while the valve automatically blocks any resulting reflux, allowing high productivity without proportionally increasing harmful effects

Inventive Principle:

Principle #24Intermediary (Mediator)

3Object-affected harmful factors

If a valve is deployed to prevent reflux, then non-target damage is reduced, but the device complexity increases

Engineering Contradiction:

Improvenon-target damage from refluxVSAvoidcatheter system complexity

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The valve is designed to be self-regulating and self-managing. It automatically responds to pressure changes in the vasculature, opening and closing as needed without requiring external control mechanisms, actuators, or complex deployment systems, thus minimizing added device complexity while providing effective reflux protection

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The valve replaces complex mechanical control systems with a passive pressure-responsive mechanism. Instead of using motors, sensors, or electronic controls to manage flow direction, the valve utilizes the natural pressure dynamics of the vasculature to control its state, substituting a simple mechanical response for a complex control system

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

The apparatus enhances distal penetration of therapeutic agents into target vessels while preventing reflux, allowing for higher doses and improved treatment efficacy by dynamically blocking reflux of embolization agents, even in rapidly changing pressure conditions.

Implementation Method 1

The pressure in a vessel at multiple locations in the vascular tree changes during an embolic infusion procedure. Initially, the pressure is high proximally, and decreases over the length of the vessel. Forward flow of therapy occurs when there is a pressure drop.

Methodology Applied

Scientific EffectPressure gradient: Pressure Gradient

Implementation Method 2

Methodology Applied

Scientific EffectElasticity: Elasticity

Data Source

PatentUS12472052B2Dynamic microvalve protection device

Publication Date: 2025.11.18 TRISALUS LIFE SCIENCES INC

AI summary

An endovascular system includes inner and outer catheters, a handle system operably coupled one end of the catheters, and a microvalve coupled to the other end of the catheters. The microvalve is constrained in a radially-collapsed closed configuration for advancement within a vessel to a treatment site. The handle system is operable to displace the inner and outer catheters portions relative to each other to move the microvalve between closed and open configurations. An indicator is provided to visually indicate the extent by which the microvalve is opened within the vessel.