Expandable Sealing Means for Endoluminal Prostheses

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Solution Overview

Problem

Conventional endovascular graft assemblies face issues with long-term durability, endoleaks, and challenges in delivering and sealing endoluminal reactants, leading to potential device migration and dislodgement, especially in patients with aortic stenosis or mitral regurgitation, where invasive surgeries pose high risks.

Innovation Solution

Development of expandable sealing means for endoluminal devices that can be controlled for activation, using a wire or pressure to expand and secure the device to the vessel wall, with a swellable material like hydrogel that activates upon contact with fluid to ensure secure placement and adapt to vascular anatomy, reducing profile and preventing leaks.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Loss of time

If conventional endovascular graft assemblies are deployed to treat aneurysms, then the procedure avoids extensive surgery and reduces recovery time, but the long-term durability is compromised due to graft separation and endoleaks

Engineering Contradiction:

Improverecovery timeVSAvoidlong-term durability

Core Design Contradiction:

Loss of timeVSReliability

Solution Approach 1:

The sealing means is pre-positioned on the endoluminal prosthesis in a compressed state during device assembly, but remains inactive until deployment. The swellable material is pre-loaded into the sealing means, ready to expand when activated by bodily fluids at the target site, ensuring proper sealing action occurs at the right time and place

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The sealing means utilizes a material that undergoes a physical parameter change from a compressed low-profile state during delivery to an expanded high-profile state after deployment. The swellable material changes volume and density when exposed to bodily fluids, transforming the sealing means from a compact configuration to an expanded sealing configuration that prevents endoleaks

Inventive Principle:

Principle #35Parameter changes

2Reliability

If the graft is expanded and anchored to the body lumen to exclude the aneurysm sac, then immediate sealing is achieved, but the device profile increases and delivery complexity increases

Engineering Contradiction:

Improvesealing effectivenessVSAvoiddelivery complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The sealing means is nested within or on the endoluminal prosthesis structure, with the swellable material contained within the sealing means. The delivery catheter encompasses both the prosthesis and sealing means assembly, creating a nested configuration that allows compact delivery while enabling sequential deployment of the prosthesis followed by activation of the sealing means

Inventive Principle:

Principle #7Nested doll (Nesting)

Solution Approach 2:

The sealing means transitions from a static compressed state during delivery to a dynamic expanded state after deployment. The system evolves from a compact deliverable configuration to an expanded functional configuration, with the sealing means adapting its shape and volume in response to activation by bodily fluids at the implantation site

Inventive Principle:

Principle #15Dynamics

3Adaptability or versatility

If a swellable material like hydrogel is used to expand the sealing means, then active conforming to leak sites is achieved, but the device profile increases upon activation

Engineering Contradiction:

Improveconforming to vascular anatomyVSAvoiddevice profile

Core Design Contradiction:

Adaptability or versatilityVSVolume of moving object

Solution Approach 1:

The swellable material is contained within a defined sealing means structure that is positioned at specific locations on the endoluminal prosthesis where sealing is most critical. The expansion occurs locally at these predetermined sites, allowing the sealing means to conform to irregularities and leak sites in the vascular anatomy while maintaining a controlled overall device profile

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

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 solution provides effective sealing with minimal profile increase, active conforming to leak sites, and the ability to remodel with vascular changes, ensuring long-term fixation and reducing the risk of endoleaks and device migration, particularly beneficial for high-risk patients.

Implementation Method 1

a swellable material like hydrogel that activates upon contact with fluid to ensure secure placement and adapt to vascular anatomy

Methodology Applied

Scientific EffectHydrogel swelling: Hydrogel

Data Source

PatentUS9216076B2Means for controlled sealing of endovascular devices

Publication Date: 2015.12.22 ENDOLUMINAL SCIENCES PTY LTD

AI summary

Expandable sealing means for endoluminal devices have been developed for controlled activation. The devices have the benefits of a low profile mechanism (for both self-expanding and balloon-expanding prostheses), contained, not open, release of the material, active conformation to the “leak sites” such that leakage areas are filled without disrupting the physical and functional integrity of the prosthesis, and on-demand, controlled activation, that may not be pressure activated.