Expansile Polymers for Delayed Controlled Vascular Occlusion

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Solution Overview

Problem

Current medical treatments for occluding structures and malformations resulting from vascular diseases lack polymers with controlled and delayed expansion rates, which are essential for precise delivery and visualization during implantation.

Innovation Solution

Development of expansile polymers, such as hydrogels, formed into filaments with a secondary expansion mechanism using a cleavable crosslinker, allowing for tailored expansion rates and incorporation of visualization agents like barium sulfate for imaging.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If polymers are designed to expand immediately upon implantation, then occlusion effect is achieved quickly, but delivery precision and safety are compromised due to inability to control expansion timing

Engineering Contradiction:
Improvedelivery precisionVSAvoidocclusion speed
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The polymer is prepared in a compressed, low-volume state before implantation that allows it to be delivered through microcatheters. The expansion action is delayed until after delivery, triggered by environmental factors such as pH change or temperature increase at the implantation site, thus achieving both precise delivery and subsequent occlusion

Inventive Principle:
Principle #10Preliminary action

2Reliability

If polymers are made with high expansion ratio to ensure complete occlusion, then occlusion effectiveness is improved, but structural integrity during delivery deteriorates

Engineering Contradiction:
Improveocclusion effectivenessVSAvoidstructural integrity
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The polymer exhibits dynamic mechanical properties that change with environmental conditions. In the delivered state, it maintains a compressed configuration with higher structural integrity. Upon triggering (pH change, temperature increase), it dynamically transitions to an expanded state with lower strength but complete occlusion, thus adapting its properties to different operational phases

Inventive Principle:
Principle #15Dynamics

3Reliability

If polymers are made transparent for biocompatibility, then biocompatibility is improved, but visualization during implantation deteriorates

Engineering Contradiction:
ImprovebiocompatibilityVSAvoidvisualization capability
Core Design Contradiction:
ReliabilityVSDifficulty of detecting and measuring

Solution Approach 1:

The polymer incorporates radiopaque materials (such as barium sulfate or iodine compounds) that do not compromise biocompatibility but provide sufficient contrast for fluoroscopic and other medical imaging visualization during delivery and implantation, allowing real-time tracking while maintaining patient safety

Inventive Principle:
Principle #32Color changes

4Manufacturing precision

If polymers are designed with complex expansion mechanisms for controlled expansion rates, then expansion control is improved, but device complexity increases

Engineering Contradiction:
Improveexpansion control precisionVSAvoidpolymer structure complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The polymer utilizes changes in environmental parameters (pH, temperature, ionic strength) to trigger and control expansion. By incorporating functional groups or materials that respond to these parameter changes, the polymer achieves controlled expansion rates without requiring complex mechanical structures or multiple components, thus maintaining simplicity while achieving precision

Inventive Principle:
Principle #35Parameter changes

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 polymers provide controlled and delayed expansion, enabling safe and precise delivery through microcatheters without immediate expansion, and visualization during implantation, effectively occluding vascular malformations.

Implementation Method 1

The second cleavable crosslinker can be an acrylate based crosslinker such as a methacrylate based crosslinker. In some embodiments, the second cleavable crosslinker can be an acrylic anhydride based crosslinker.

Methodology Applied
Scientific EffectHydrolysis: Hydrolysis

Implementation Method 2

The monomer used in the herein described polymers can be pH sensitive and provide a first expansion to the expansile polymer.

Methodology Applied
Scientific EffectIonization: Ionisation

Implementation Method 3

The expansile devices can include at least one visualization element, which can be metallic powders, gadolinium, superparamagnetic iron oxide particles, barium sulfate, or a combination thereof.

Methodology Applied
Scientific EffectX-ray scattering: X-Ray

Data Source

PatentUS11759547B2Polymers
Publication Date: 2023.09.19 MICROVENTION INC
  • US11759547B2 patent drawing
  • US11759547B2 patent drawing
  • US11759547B2 patent drawing

AI summary

Described herein are polymers and associated methods to occlude structures and malformations of the vasculature with polymers with delayed controlled rates of expansion. Methods of forming such devices are also disclosed.