In-situ Forming Foam Outer Layer for Aneurysm Sealing

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Solution Overview

Problem

Current treatments for aneurysms, particularly endovascular aneurysm repair (EVAR), face challenges with endoleaks due to insufficient sealing and fluid movement, which can lead to aneurysm expansion or rupture, and existing solutions require pre-formed foams that cannot conform to the aneurysm sac's configuration.

Innovation Solution

In-situ forming polymer foams that react within the aneurysm sac to generate a gas and form a foam structure with a skin, providing conformal contact and minimizing endoleaks, using a one-part, two-part, or multi-part polymer formulation that expands to fill the sac and stabilize pressure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If pre-formed foams are used to fill the aneurysm sac, then the foam can be easily delivered and deployed, but the foam cannot conform to the aneurysm sac's configuration, leading to insufficient sealing and endoleaks

Engineering Contradiction:

Improveease of deliveryVSAvoidconformal contact

Core Design Contradiction:

Ease of operationVSManufacturing precision

Solution Approach 1:

The foam undergoes parameter changes by transitioning from a liquid or semi-liquid injectable state to an expanded solid foam state in-situ within the aneurysm sac. This phase change allows the material to adapt its volume and shape to conform precisely to the irregular geometry of the aneurysm sac, achieving both ease of delivery (as liquid) and conformal contact (after expansion).

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The foam is designed to be dynamic rather than static, allowing it to expand and adapt its shape after delivery. The foam transitions from a deliverable liquid state to an expanded foam state that dynamically conforms to the aneurysm sac's configuration, providing both ease of delivery and precise sealing.

Inventive Principle:

Principle #15Dynamics

2Manufacturing precision

If the foam expands to fill the aneurysm sac, then conformal contact is achieved, but the foam may move outside the targeted treatment zone causing complications

Engineering Contradiction:

Improveconformal contactVSAvoidmaterial movement

Core Design Contradiction:

Manufacturing precisionVSObject-affected harmful factors

Solution Approach 1:

The foam develops different properties in different regions: the outer layer forms a solid skin or crust that acts as a barrier to prevent movement, while the inner portions remain as expandable foam cells that provide conformal contact. This local differentiation of properties allows the foam to both conform to the sac geometry and remain contained within the treatment zone.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The foam forms an outer skin or thin film layer that acts as a flexible containment shell. This outer layer prevents the foam from moving outside the targeted aneurysm sac while allowing the inner foam structure to expand and conform to the sac's irregular shape, achieving both conformal contact and containment.

Inventive Principle:

Principle #30Flexible shells and thin films

3Manufacturing precision

If the foam reacts in-situ to generate gas and form structure, then conformal contact is achieved, but the reaction time and foaming process add complexity

Engineering Contradiction:

Improveconformal contactVSAvoidreaction process

Core Design Contradiction:

Manufacturing precisionVSDevice complexity

Solution Approach 1:

The foam formulation is self-reacting, utilizing chemical reactions that occur automatically upon injection without requiring external triggers or complex control systems. The foam self-generates gas bubbles and self-structures into the final foam configuration, achieving conformal contact while minimizing the complexity of the delivery system.

Inventive Principle:

Principle #25Self-service

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 in-situ forming foams effectively seal the aneurysm sac, reducing endoleak risk and stabilizing pressure without requiring knowledge of the aneurysm configuration, thereby improving patient outcomes by minimizing complications and mortality associated with EVAR procedures.

Implementation Method 1

forming an in-situ forming foam between the exterior surface of the medical device and the tissue surface of the aneurysm. The in-situ forming foam comprises a polymer that reacts in-situ to generate a gas and form a foam structure

Methodology Applied

Scientific EffectGas generation through polymer reaction: Chemical Bonding

Implementation Method 2

The polymer reacts in-situ to generate a gas and form a foam structure comprising a first portion comprising a skin and a second portion within the first portion

Methodology Applied

Scientific EffectFoam formation and expansion: Foam

Implementation Method 3

providing conformal contact and minimizing endoleaks, using a one-part, two-part, or multi-part polymer formulation that expands to fill the sac and stabilize pressure

Methodology Applied

Scientific EffectConformal contact sealing: Adhesive

Data Source

PatentUS9883865B2In-situ forming foams with outer layer

Publication Date: 2018.02.06 ARSENAL MEDICAL INC

AI summary

Systems, methods and kits relating to in-situ forming polymer foams for the treatment of aneurysms or fluid filled spaces are disclosed. The systems include an insertable medical device and an in-situ forming foam of lava like materials with a fast forming outer skin and a slower hardening interior that is formed from a one-, two- or multi-part formulation. When used to treat an aneurysm, the foam is placed into contact with at least a portion of an exterior surface of the medical device and/or the tissue surface of the aneurysm.