Catheter Sleeve Segmentation for Stent Deployment Force Reduction

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Solution Overview

Problem

Current endoluminal delivery systems for expandable stents and stent grafts face challenges in compacting and deploying devices within the vasculature due to the need for precise radial constraining and releasing mechanisms, which can be cumbersome and require significant force.

Innovation Solution

A catheter assembly utilizing a single flexible sleeve with multiple releasable seams allows for selective axial and rotational positioning of expandable devices before full deployment, using a flexible constraining sleeve that maintains the device in an intermediate state until fully expanded, facilitating smoother deployment and engagement with vascular walls.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Force

If a conventional constraining sheath is used to maintain the endoprosthesis in a compacted state, then the device can be delivered through the vasculature, but significant force is required to release and deploy the endoprosthesis

Engineering Contradiction:
Improveforce required for releaseVSAvoiddeployment operation
Core Design Contradiction:
ForceVSEase of operation

Solution Approach 1:

The constraining sheath is divided into multiple segments or sections along its length. Each segment can be independently released or detached, allowing the endoprosthesis to be deployed in a controlled, sequential manner rather than requiring simultaneous release of the entire sheath. This segmentation reduces the peak force needed for deployment by distributing the release process across multiple smaller actions.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The constraining sheath incorporates dynamic characteristics through its material composition and structural design, allowing it to transition from a rigid constraining state to a flexible released state. The sheath may include shape memory materials or phase-changing materials that respond to temperature or other environmental cues, enabling controlled deployment with reduced force requirements compared to static constraining mechanisms.

Inventive Principle:
Principle #15Dynamics

2Productivity

If the endoprosthesis is rapidly deployed from the delivery catheter, then the procedure is faster, but precise positioning and control during deployment is compromised

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

Solution Approach 1:

The delivery system is designed to pre-position the endoprosthesis and associated deployment mechanisms at the target site before actual deployment occurs. The catheter system includes positioning features such as markers, radiopaque elements, or navigation capabilities that allow the operator to accurately locate the device beforehand. This preliminary positioning ensures that when rapid deployment occurs, the endoprosthesis is already at the correct location, maintaining precision without sacrificing speed.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The deployment process utilizes periodic or staged action rather than a single continuous motion. The endoprosthesis can be deployed in controlled stages or with periodic pulses of expansion force, allowing brief pauses or controlled intervals during which positioning can be verified and adjusted if needed. This periodic deployment maintains both speed and precision by breaking the rapid deployment into manageable phases.

Inventive Principle:
Principle #19Periodic action

3Device complexity

If a non-corrugated constraining sheath is used, then the structure is simpler, but the release process requires more maximum force and is less smooth

Engineering Contradiction:
Improvesheath structureVSAvoidmaximum force for release
Core Design Contradiction:
Device complexityVSForce

Solution Approach 1:

The constraining sheath incorporates corrugations or curved structural features along its length, creating a series of expansion zones that facilitate gradual release. These corrugations act as mechanical advantage points that distribute the release force across multiple expansion zones rather than requiring single-point force application. The curved geometry of the corrugations allows for smoother deformation during release, reducing the peak force required while maintaining structural integrity during delivery.

Inventive Principle:
Principle #14Spheroidality (Curvature)

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

This approach enables more precise and efficient deployment of expandable devices within the vasculature, reducing the force required for release and allowing for better engagement with vascular tissue, thus improving the minimally invasive nature of endoluminal therapies.

Implementation Method 1

The endoprosthesis is designed to spontaneously dilate (i.e., elastically recover) or to be balloon-expanded from their delivery diameter

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Implementation Method 2

They are designed to spontaneously dilate (i.e., elastically recover) or to be balloon-expanded from their delivery diameter

Methodology Applied
Scientific EffectElastic recovery: Elasticity

Implementation Method 3

to be balloon-expanded from their delivery diameter

Methodology Applied
Scientific EffectBalloon expansion: Pressure Increase

Data Source

PatentEP2637611B1Deployment catheter for endoluminal devices
Publication Date: 2019.10.02 WL GORE & ASSOC INC
  • EP2637611B1 patent drawingFigure 1
  • EP2637611B1 patent drawingFigure 2a~2c
  • EP2637611B1 patent drawingFigure 3a~3c

AI summary

A catheter assembly includes a single sleeve that constrains an expandable device to a dimension suitable for endoluminal delivery of the device to a treatment site, and further allows expansion of the device toward an outer peripheral dimension that is smaller than a fully deployed outer peripheral dimension to allow positioning of the device at the treatment site prior to full deployment and expansion of the device at the treatment site.