Self-Adaptive Embolic Coil with Shape-Memory Alloy

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Solution Overview

Problem

Conventional embolic coils struggle to conform to the specific shape and diameter of aneurysm sacs, leading to suboptimal fit, increased procedure time, cost, and risk of coil prolapse, and lack a reliable method for retraction and recapture.

Innovation Solution

A self-adaptive embolic coil system with a delivery assembly that utilizes a shape-memory alloy and gripper assembly to deploy, reconnect, and disconnect the coil, allowing it to conform to the aneurysm sac's shape and size, and enabling controlled repositioning and retrieval.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If conventional predetermined three dimensional shaped coils are used, then the coil structure is stable and easy to manufacture, but the coil cannot adapt to different aneurysm shapes and sizes

Engineering Contradiction:
Improveadaptability to aneurysm shapeVSAvoidcoil structure complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The coil structure transitions from a static predetermined three dimensional shape to a dynamic configuration that can adapt to different aneurysm geometries. The delivery system enables the coil to be deployed in a controlled manner, allowing it to conform to the specific shape and size of the target aneurysm rather than maintaining a fixed pre-formed shape.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The invention changes the deployable parameters of the coil by using a delivery system that controls the expansion and positioning of the coil after insertion. Instead of relying on a fixed pre-formed shape, the coil's final configuration is determined by deployment parameters such as expansion force, positioning depth, and radial expansion, allowing adaptation to various aneurysm dimensions.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If multiple conventional coils are deployed to fill the aneurysm sac, then complete occlusion is achieved, but procedure time and cost increase

Engineering Contradiction:
Improveocclusion effectivenessVSAvoidprocedure time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The invention merges multiple coil functions into a single deployable unit. The delivery system enables one coil to perform the work of multiple conventional coils by controlling its expansion and conformation to fill the aneurysm sac effectively, reducing the number of separate deployment actions required.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The delivery system performs preliminary positioning and configuration actions before coil deployment. The system pre-positiones the coil at the aneurysm site and prepares it for optimal expansion, ensuring that a single deployed coil achieves complete sac filling and occlusion without requiring multiple sequential coil insertions.

Inventive Principle:
Principle #10Preliminary action

3Reliability

If conventional coils are deployed, then embolization is achieved, but coil prolapse and dislodgement risk increases

Engineering Contradiction:
Improvecoil stabilityVSAvoidcoil prolapse risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The delivery system incorporates feedback mechanisms to monitor coil deployment and positioning in real-time. The system provides visual and mechanical feedback to ensure the coil is properly positioned and secured within the aneurysm sac before releasing it, allowing the operator to detect and correct potential prolapse risks before they occur.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The delivery system employs a controlled deployment mechanism that gradually expands and secures the coil within the aneurysm sac before full release. This staged deployment process cushions against sudden coil dislodgement or prolapse by ensuring the coil is properly anchored to the sac walls before complete expansion occurs.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

4Ease of operation

If conventional mechanical disconnect systems are used, then coil release is achieved, but coil repositioning is not possible

Engineering Contradiction:
Improvecoil release capabilityVSAvoidcoil repositioning capability
Core Design Contradiction:
Ease of operationVSAdaptability or versatility

Solution Approach 1:

The delivery system employs a dynamic disconnect mechanism that allows reversible coil release and re-capture. Unlike conventional mechanical disconnect systems that permanently release the coil, this system enables the operator to disconnect and reconnect the coil multiple times, providing flexibility for repositioning and adjustment after initial deployment.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The invention implements a recoverable disconnect system where the coil can be released from the delivery system and then re-captured if needed. The disconnect mechanism allows the coil to be discarded from the catheter for deployment, but also enables recovery and re-attachment, providing the versatility to reposition the coil if optimal positioning is not achieved on the first attempt.

Inventive Principle:
Principle #34Discarding and recovering

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 system reduces the number of coils needed, decreases procedure time and cost, and minimizes the risk of coil prolapse and complications by providing a precise, adaptive, and controllable embolic coil deployment and retrieval mechanism.

Implementation Method 1

A self-adaptive embolic coil system with a delivery assembly that utilizes a shape-memory alloy and gripper assembly to deploy, reconnect, and disconnect the coil, allowing it to conform to the aneurysm sac's shape and size

Methodology Applied
Scientific EffectShape-memory alloy: Shape Memory Alloy

Data Source

PatentEP2944278B1Delivery system for a retractable and rapid disconnect, floating diameter embolic coil product
Publication Date: 2024.04.17 NDI TIP TEKNOLOJILERI ANONIM SIRKETI
  • EP2944278B1 patent drawingFigure 1A~3
  • EP2944278B1 patent drawingFigure 4~5B
  • EP2944278B1 patent drawingFigure 6A~10

AI summary

A vaso-occlusive device and delivery system to a selected site of the vessel in a manner allowing the vaso-occlusive device to substantially assumes a diameter of an inner surface of the vessel or aneurism sac at the site of the embolization procedure is disclosed. The vaso-occlusive device or embolic coil has specific properties for conforming to the diameter of the aneurysm sac thereby enabling retractability and rapid disconnect detachment .The vaso-occlusive device or embolic coil has a predetermined shape requiring fewer embolic coils per embolization procedure advantageously improving patient risk, and the cost and time of the procedure. A method for deploying the embolic coil with such specific properties to the site of an aneurysm using a delivery system configured for deploying the embolic coil features inserting, and/or reconnecting for positioning and reinserting the embolic coil is disclosed.