Bioactive Coated Embolization Device for Aneurysm Occlusion

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Solution Overview

Problem

Current embolization devices for treating aneurysms, such as metallic coils, often fail to completely pack the aneurysm lumen, leading to re-canalization, enlargement, and potential rupture, and lack biocompatibility and thrombus-promoting characteristics, resulting in inadequate treatment outcomes for patients with intracranial aneurysms.

Innovation Solution

Development of embolization devices with unique bioactive coatings comprising a biotropic extracellular matrix (ECM) material with self-assembled collagen fibrils and bioactive agents like proteoglycans, growth factors, or glycosaminoglycans, which can be applied to metallic or synthetic coils to enhance thrombogenicity and promote healing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If metallic embolization coils are used to treat aneurysms, then the procedure is minimally invasive and can be delivered via catheter, but the coils fail to completely pack the aneurysm lumen and lack thrombus-promoting characteristics

Engineering Contradiction:
Improveminimally invasive deliveryVSAvoidcomplete packing of aneurysm lumen
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent applies composite materials by coating metallic embolization coils with biotropic extracellular matrix (ECM) materials. This creates a hybrid structure combining the mechanical properties of metal coils with the biological functionality of ECM, enabling both easy delivery and effective thrombus promotion. The ECM coating layer contains bioactive agents that enhance thrombogenicity while the metallic core provides structural integrity for catheter delivery.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent changes the surface parameters of metallic coils by applying ECM coatings with specific biochemical properties. The coating modifies surface thrombogenicity, biocompatibility, and blood interaction characteristics, transforming the coil from a purely mechanical occlusion device to one that actively promotes thrombus formation and healing.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If metallic coils are implanted in aneurysms, then occlusion can be achieved, but the coils do not promote healing and may cause re-canalization or rupture

Engineering Contradiction:
Improveocclusion of aneurysmVSAvoidre-canalization and rupture risk
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent converts the potentially harmful foreign body response to metallic coils into a beneficial healing process by coating the coils with biotropic ECM materials. The ECM coating promotes controlled thrombus formation and tissue ingrowth, transforming the coil from a foreign object that causes re-canalization into a scaffold that facilitates healing and permanent occlusion.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

Solution Approach 2:

The ECM coating acts as an intermediary between the metallic coil and the biological environment. It mediates the interaction by providing a biocompatible interface that promotes thrombus formation, cell attachment, and tissue integration, reducing the direct harmful contact between metal and biological tissues.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Device complexity

If standard embolization devices are used, then the procedure is simple, but the devices lack biocompatibility and thrombus-promoting characteristics

Engineering Contradiction:
Improvesimplicity of deviceVSAvoidlack of biocompatibility
Core Design Contradiction:
Device complexityVSObject-generated harmful factors

Solution Approach 1:

The patent applies local quality by coating only the surface of the embolization device with biotropic ECM materials. The bulk metallic structure maintains its simple, proven design for easy delivery, while the localized surface coating provides enhanced biocompatibility and thrombus-promoting characteristics. This allows the device to maintain simplicity while gaining biological functionality.

Inventive Principle:
Principle #3Local quality

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 bioactive-coated embolization devices effectively occlude aneurysmal lumens, reduce device migration, and facilitate healing, thereby improving treatment outcomes for patients with intracranial aneurysms by providing enhanced thrombogenicity and biocompatibility.

Implementation Method 1

The coating material comprises a biotropic extracellular matrix (ECM) material comprising a network of self-assembled collagen fibrils

Methodology Applied
Scientific EffectSelf-assembly: Self-Assembly

Implementation Method 2

at least one bioactive agent retained in the ECM material. The bioactive agent is selected from the group consisting of a proteoglycan, a growth factor, a glycoprotein, and a glycosaminoglycan

Methodology Applied
Scientific EffectAdsorption: Adsorption

Data Source

PatentEP2259809B1Coated embolization device
Publication Date: 2016.05.25 COOK BIOTECH INC
  • EP2259809B1 patent drawingFigure 1
  • EP2259809B1 patent drawingFigure 2A~2B
  • EP2259809B1 patent drawingFigure 3A~3B

AI summary

Described are embolization devices having unique bioactive coatings, as well as methods for their manufacture and use. An illustrative embolization device of the invention comprises an embolic body and a coating material comprising biotropic extracellular matrix material immobilized on a surface of the embolic body. The biotropic extracellular matrix material comprises a network of self-assembled collagen fibrils, and comprises at least one bioactive agent retained in the extracellular matrix material, wherein the bioactive agent is selected from the group consisting of a proteoglycan, a growth factor, a glycoprotein, and a glycosaminoglycan. In certain forms, such an extracellular matrix material comprises a remodelable, angiogenic extracellular matrix material, for example, a submucosa material such as but not limited to porcine small intestinal submucosa.