Braided Occlusion Device Nested in Diagnostic Catheter

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Solution Overview

Problem

Conventional medical devices for treating vascular abnormalities are bulky, making it difficult to deliver them to small target sites, such as those in children, and require exchanging diagnostic catheters for delivery, which is inefficient and time-consuming. There is a need for a device that can be deployed through a diagnostic catheter, provide rapid occlusion, and be accurately fixated within a target site.

Innovation Solution

A medical device comprising a braided fabric of wire strands, configured for delivery through a diagnostic catheter as small as 4-5 French, with a delivery system that engages diagnostic catheters of varying sizes, allowing for rapid occlusion and fixation within a target site using shape memory alloys and thrombogenic materials to facilitate blood flow inhibition and clot formation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Volume of moving object

If conventional medical devices are used, then occlusion function is achieved, but device bulkiness makes it difficult to deliver to small target sites

Engineering Contradiction:
Improvedevice profileVSAvoidocclusion effectiveness
Core Design Contradiction:
Volume of moving objectVSReliability

Solution Approach 1:

The occlusion device is nested within a delivery catheter in a compressed state during delivery, then deployed outward to achieve its full occlusion function at the target site. This allows the device to pass through small catheters (4-5 French) while maintaining its effectiveness when deployed.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The device transitions from a static compressed state during delivery to a dynamic expanded state at the target site. This dynamic transformation allows the same device to satisfy both the small profile requirement for delivery and the large size requirement for effective occlusion.

Inventive Principle:
Principle #15Dynamics

2Productivity

If diagnostic catheter exchange is performed, then device delivery is enabled, but treatment time is increased

Engineering Contradiction:
Improvetreatment efficiencyVSAvoidcatheter exchange time
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The delivery catheter is designed to serve dual purposes: first as a diagnostic catheter for imaging and measurement, then as a delivery catheter for deploying the occlusion device. This eliminates the need for catheter exchange and streamlines the treatment process.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The diagnostic and delivery functions are merged into a single catheter system. The occlusion device is loaded into the same catheter used for diagnosis, combining what were previously separate procedural steps into one continuous process.

Inventive Principle:
Principle #5Merging (Combining)

3Productivity

If device delivery time is reduced, then treatment efficiency is improved, but positioning accuracy may be compromised

Engineering Contradiction:
Improvedeployment speedVSAvoidpositioning accuracy
Core Design Contradiction:
ProductivityVSManufacturing precision

Solution Approach 1:

The device is pre-loaded into the delivery catheter in a controlled environment before patient procedure. This preliminary preparation allows for precise positioning planning while maintaining rapid deployment capability during the actual procedure.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

Manual positioning and adjustment mechanisms are replaced with a controlled deployment system that uses the delivery catheter as a guide. The device is pushed through the catheter to the predetermined target location, reducing reliance on manual dexterity and increasing both speed and accuracy.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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 can be efficiently deployed through a diagnostic catheter, providing rapid occlusion of vascular abnormalities with reduced force requirements and accurate placement, allowing for effective treatment of various target sites without the need for catheter exchange, enhancing treatment efficiency and precision.

Implementation Method 1

using shape memory alloys and thrombogenic materials to facilitate blood flow inhibition and clot formation

Methodology Applied
Scientific EffectShape memory alloy: Shape Memory Alloy

Implementation Method 2

using shape memory alloys and thrombogenic materials to facilitate blood flow inhibition and clot formation

Methodology Applied
Scientific EffectCoagulation: Coagulation

Data Source

PatentEP2244666B1Medical devices for treating a target site
Publication Date: 2023.09.13 AGA MEDICAL CORP
  • EP2244666B1 patent drawingFigure 1~3
  • EP2244666B1 patent drawingFigure 4
  • EP2244666B1 patent drawingFigure 5

AI summary

Embodiments of the present invention provide devices and methods for treating various target sites, such as vascular abnormalities. For example, a medical device according to one embodiment includes at least one layer of a fabric of braided strands having proximal and distal ends and a central axis extending therebetween. The medical device has an expanded configuration a generally frastroconical shaped portion at each end. The medical device is configured to be constrained to a reduced configuration for delivery through a diagnostic catheter and to at least partially return, when unconstrained, towards the expanded configuration.