Radiopaque Hydrogel Microspheres for Embolization Imaging

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Solution Overview

Problem

Current radiopaque embolic materials for embolization procedures lack consistency and reproducibility, as they either precipitate unpredictably or require mixing with contrast agents, leading to unclear localization and monitoring challenges during and after procedures.

Innovation Solution

Development of radiopaque hydrogel microspheres with covalently attached iodine or bromine through cyclic acetal linkages, ensuring intrinsic radiopacity and controlled drug loading and elution, allowing for precise imaging and monitoring during and after embolization.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Difficulty of detecting and measuring

If radiopaque materials are used for embolization, then imaging capability is improved, but precision and reproducibility of embolus formation deteriorate

Engineering Contradiction:
Improveimaging capabilityVSAvoidprecision of embolus formation
Core Design Contradiction:
Difficulty of detecting and measuringVSManufacturing precision

Solution Approach 1:

The patent combines radiopacity and precise embolization function into a single integrated microsphere system. The radiopaque contrast agent is incorporated into the microsphere matrix during manufacturing, eliminating the need for separate contrast materials and enabling both precise imaging and controlled embolization from one product.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The invention uses composite microspheres consisting of a polymer matrix (e.g., PVA, gelatin, or dextran) combined with radiopaque contrast agents (e.g., barium sulfate, bismuth subcarbonate, or iodinated compounds). This composite structure provides both the embolization function of the polymer and the imaging function of the radiopaque material.

Inventive Principle:
Principle #40Composite materials

2Difficulty of detecting and measuring

If non-radiopaque embolic particles are mixed with radiopaque materials, then imaging is enabled, but localization clarity deteriorates

Engineering Contradiction:
Improveimaging capabilityVSAvoidlocalization clarity
Core Design Contradiction:
Difficulty of detecting and measuringVSMeasurement precision

Solution Approach 1:

The patent merges the embolic particle and radiopaque contrast agent into a single homogeneous composite microsphere. This eliminates the mixing interface between separate materials, providing uniform radiopacity throughout the embolic material and enabling clear, unambiguous localization of the embolus.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The radiopaque contrast agent is uniformly distributed within the polymer matrix of the microsphere, creating a homogeneous composite material. This homogeneity ensures consistent radiopacity throughout the embolic material, improving imaging clarity and localization precision.

Inventive Principle:
Principle #33Homogeneity

3Reliability

If embolic microspheres are used, then reproducibility is improved, but intrinsic radiopacity deteriorates

Engineering Contradiction:
ImprovereproducibilityVSAvoidradiopacity
Core Design Contradiction:
ReliabilityVSDifficulty of detecting and measuring

Solution Approach 1:

The patent creates composite microspheres by incorporating radiopaque contrast agents into the polymer matrix during the microsphere manufacturing process. This results in microspheres that maintain the size control and reproducibility of standard embolic microspheres while gaining intrinsic radiopacity for imaging.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The radiopaque embolic microspheres serve multiple functions simultaneously: they provide controlled embolization through their size and shape, deliver drugs or therapeutic agents through their matrix structure, and enable imaging through their intrinsic radiopacity. This multi-functionality eliminates the need for separate contrast materials.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 radiopaque microspheres provide consistent and reproducible embolization with enhanced imaging capabilities, allowing for precise placement and prolonged monitoring of embolic materials, improving procedural outcomes and extending the post-procedural imaging window.

Implementation Method 1

a polymer comprising 1,2-diol or 1,3-diol groups acetalised with a radiopaque species

Methodology Applied
Scientific EffectCyclic acetal linkage: Chemical Bonding

Implementation Method 2

Radiopacity, refers to the property of obstructing, or attenuating, the passage of electromagnetic radiation, particularly x-rays

Methodology Applied
Scientific EffectRadiopacity: Absorption (EM radiation)

Data Source

PatentEP4000639A1Imageable polymers
Publication Date: 2022.05.25 BOSTON SCI MEDICAL DEVICE LTD
  • EP4000639A1 patent drawingFigure 1
  • EP4000639A1 patent drawingFigure 2B~2C
  • EP4000639A1 patent drawingFigure 3

AI summary

This invention relates to imageable polymers, particularly those comprising poly vinylalcohol and to methods for making them as well as to embolic microspheres comprising the polymers. The microspheres are imageable during embolization procedures and can be loaded with drugs or other therapeutic agents to provide an imageable drug delivery system.