Expandable Vascular Drug Delivery for Local Occlusion

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Solution Overview

Problem

Existing vascular drug delivery devices face challenges such as dilution of therapeutic agents, migration away from the treatment site, and adverse effects due to vessel tortuosity, particularly in treating conditions like saphenous vein incompetence.

Innovation Solution

A vascular delivery device with an expandable member and drug delivery component that applies therapeutic agents closely to surrounding tissue, displaces fluid to occlude the vessel, and includes a bioabsorbable implant for controlled delivery and occlusion, using materials like PTFE and polyurethane to navigate tortuous vessels.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If systemic administration of therapeutic agents is used, then the entire body is treated, but unwanted effects occur on non-target areas and high concentrations cannot be achieved at localized sites

Engineering Contradiction:
Improveconcentration of therapeutic agentVSAvoidunwanted effects on non-target areas
Core Design Contradiction:
Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The patent applies local quality by delivering therapeutic agents directly to the target vessel through a catheter-based delivery system. The expandable member (balloon) is positioned at the specific treatment site, allowing high concentration of sclerosant to be applied locally without systemic distribution, thereby achieving effective treatment concentration while avoiding unwanted effects on non-target areas.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent uses an intermediary delivery system consisting of a catheter with an expandable member (balloon) that acts as a mediator between the therapeutic agent and the target vessel. This intermediary device enables controlled local delivery of the sclerosant, allowing precise placement at the treatment site while preventing premature contact with non-target tissues.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Quantity of substance

If therapeutic agent is delivered through vasculature, then the agent reaches the target area, but dilution occurs with body fluids reducing efficacy

Engineering Contradiction:
Improveamount of therapeutic agentVSAvoiddilution with body fluids
Core Design Contradiction:
Quantity of substanceVSLoss of substance

Solution Approach 1:

The patent applies preliminary action by pre-loading the expandable member (balloon) with the therapeutic agent (sclerosant) before deployment. The balloon is inflated at the target site, creating a contained reservoir that delivers the agent directly to the vessel wall. This preliminary preparation ensures the full concentration of the therapeutic agent is delivered locally without being diluted by body fluids during transit through the vasculature.

Inventive Principle:
Principle #10Preliminary action

3Reliability

If sclerosant is used for chemical ablation, then effective treatment of incompetent vein is achieved, but migration causes adverse effects such as thrombosis and embolism

Engineering Contradiction:
Improvetreatment efficacyVSAvoidmigration causing thrombosis and embolism
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent uses the expandable member (balloon) as an intermediary device that controls and contains the sclerosant during delivery. The balloon acts as a barrier that prevents premature migration of the sclerosant through the vasculature, allowing controlled contact with the target vessel wall only at the intended treatment site, thereby preventing adverse effects such as thrombosis and embolism while maintaining treatment efficacy.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent employs a flexible expandable member (balloon) made of thin film material that can be inflated to contact the vessel wall. This flexible shell structure provides a contained delivery system that prevents uncontrolled migration of the sclerosant, allowing precise localization of the therapeutic agent at the treatment site while minimizing the risk of embolism and other adverse effects.

Inventive Principle:
Principle #30Flexible shells and thin films

4Adaptability or versatility

If treatment is applied to tortuous vessels like GSV, then the target area can be reached, but device navigation and drug delivery become difficult

Engineering Contradiction:
Improveability to treat tortuous vesselsVSAvoiddevice navigation difficulty
Core Design Contradiction:
Adaptability or versatilityVSEase of operation

Solution Approach 1:

The patent applies dynamics by using a flexible catheter system with an expandable member that can adapt to the tortuous anatomy of vessels like the GSV. The catheter and balloon are designed to be flexible and conformable, allowing them to navigate curved and tortuous vessel paths. Once positioned, the balloon can be inflated to provide stable contact with the vessel wall despite the tortuosity, enabling effective drug delivery in challenging anatomical configurations.

Inventive Principle:
Principle #15Dynamics

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 device reduces the amount of therapeutic agent required and minimizes migration, effectively treating the target site with minimal side effects by ensuring close proximity and controlled delivery.

Implementation Method 1

the expandable member is expanded within the lumen to a second volume, thereby applying a compressive force to the drug infusible layer and occluding a portion of the lumen

Methodology Applied
Scientific EffectFluid displacement:

Implementation Method 2

the drug delivery component is in close proximity to the surrounding tissue along a length of the device and transfers a therapeutic agent to the surrounding tissue along this length

Methodology Applied
Scientific EffectDirect contact transfer:

Data Source

PatentEP4166098B1Vascular drug delivery devices
Publication Date: 2025.09.17 WL GORE & ASSOC INC
  • EP4166098B1 patent drawingFigure 1A~1B
  • EP4166098B1 patent drawingFigure 2A~2B
  • EP4166098B1 patent drawingFigure 2C

AI summary

Embodiments of the present disclosure comprise occlusion and drug delivery devices and methods. One aspect of the disclosure comprises a drug delivery device comprising an inner expansion member and an outer drug delivery component. Another aspect of the disclosure comprises bioabsorbable, lumen-occluding implants.