Shape Memory Occlusion Device with Membranous Fringes

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Current medical devices for occluding bodily lumens, cavities, or vessels often fail to provide adequate and sustained blockage of fluid flow, particularly in conditions like aneurysms and arteriovenous malformations, as they rely solely on device deployment and thrombus formation, which may not be sufficient for all cases.

Innovation Solution

The development of implantable occlusion devices incorporating shape memory wires and flexible membranous materials, such as ePTFE, with external fringes or cup-shaped configurations that expand to block fluid flow, enhancing thrombogenicity and endothelialization, and including endothelization promoting agents to ensure effective occlusion.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional occlusion devices are deployed, then device placement is achieved, but adequate and sustained blockage of fluid flow is not provided

Engineering Contradiction:

Improveocclusion effectivenessVSAvoiddevice structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The occlusion device combines shape memory alloy wire with flexible membranous material (e.g., ePTFE) to create a composite structure. The shape memory wire provides structural integrity and shape transformation capability, while the membranous material provides thrombogenicity and occlusion function. This composite approach resolves the contradiction by achieving reliable occlusion through material synergism rather than increasing structural complexity.

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The device incorporates fringes or projections on specific portions of the membranous material to enhance thrombogenicity locally. Rather than making the entire device complex, the local quality principle applies by concentrating the occlusion-enhancing features at critical locations (edges and surfaces contacting blood flow), while the rest of the structure remains simple and flexible.

Inventive Principle:

Principle #3Local quality

2Adaptability or versatility

If shape memory materials are used, then device expandability is improved, but device profile size increases

Engineering Contradiction:

Improvedevice expandabilityVSAvoiddevice profile size

Core Design Contradiction:

Adaptability or versatilityVSVolume of moving object

Solution Approach 1:

The shape memory wire enables the device to dynamically transform from a compressed delivery profile to an expanded operational profile. The wire's shape memory properties allow it to be deformed into a compact configuration for catheter delivery, then automatically expand to the intended three-dimensional occlusive shape upon deployment. This dynamic transformation resolves the contradiction between small delivery profile and large operational profile.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The occlusion device is designed to nest within itself during delivery, with the membranous material and fringes folded or compressed around the shape memory wire core. This nested configuration minimizes the device profile during delivery through the catheter, while allowing full expansion to the functional occlusive shape at the target site, resolving the profile size contradiction.

Inventive Principle:

Principle #7Nested doll (Nesting)

3Reliability

If membranous material is added to enhance thrombogenicity, then occlusion capability is improved, but device complexity increases

Engineering Contradiction:

ImprovethrombogenicityVSAvoidmaterial composition

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The device uses a thin flexible membranous material (such as ePTFE) that conforms to the shape of the occlusion device. This thin film approach provides sufficient surface area for thrombogenicity enhancement without adding significant bulk or structural complexity. The membrane can be simple in design while still achieving the desired biological response through its surface properties and geometry.

Inventive Principle:

Principle #30Flexible shells and thin films

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

These devices provide enhanced occlusive capabilities by combining shape memory properties with thrombogenic and endothelial promoting agents, ensuring robust and sustained blockage of fluid flow, reducing the risk of device migration and promoting healing.

Implementation Method 1

at least one wire having shape memory properties

Methodology Applied

Scientific EffectShape memory properties: Shape Memory Alloy

Implementation Method 2

enhancing the profile size and the thrombogenicity of the occlusion devices

Methodology Applied

Scientific EffectThrombogenicity: Coagulation

Data Source

PatentUS11529145B2Occlusion devices and methods of their manufacture and use

Publication Date: 2022.12.20 WL GORE & ASSOC INC

AI summary

Disclosed are implantable medical devices for the occlusion of a bodily lumen, cavity, vessel, or organ, as well as methods for manufacturing such occlusion devices, and methods for treating a subject using the occlusion devices. The devices generally include a wire having shape memory properties and a flexible membranous material disposed about the wire. Some embodiments include a lateral fringe on the membranous material. Some embodiments include a fluid capture cup affixed to the wire.