Guidewire Adjuster for Stent Positioning in Aortic Arch

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Solution Overview

Problem

Conventional delivery systems face challenges in adjusting the position of a stent during interventional procedures, particularly in the aortic arch area, where the sheath cannot effectively transmit movement to the stent, leading to unsatisfactory clinical results due to the stent being positioned lower than expected.

Innovation Solution

A guidewire adjuster with a support mechanism and driving mechanism that allows for axial movement of the guidewire relative to the sheath, connected to a control handle, enabling the stent to be adjusted upwardly by advancing the guidewire and thus the sheath at the aortic arch, ensuring precise positioning.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If the sheath is withdrawn to adjust stent position, then the stent can be moved upward, but the sheath gets locked at the inner side of the aortic arch bending portion and cannot transmit movement

Engineering Contradiction:
Improvestent positioning accuracyVSAvoidsheath movement capability
Core Design Contradiction:
Manufacturing precisionVSEase of operation

Solution Approach 1:

The delivery system is divided into separate functional components: the sheath, the core shaft, and the guidewire adjuster. The guidewire adjuster can be independently operated to move the guidewire relative to the sheath, allowing stent position adjustment without requiring sheath movement. This segmentation resolves the contradiction by providing an alternative adjustment mechanism that avoids the sheath locking issue in the aortic arch.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The guidewire acts as an intermediary element between the operator and the stent. By adjusting the guidewire position through the guidewire adjuster, the stent can be moved upward without directly moving the sheath. This intermediary approach allows position adjustment while avoiding the sheath's interaction with the aortic arch bending portion.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Manufacturing precision

If the sheath is advanced forward to adjust stent position, then the stent can be moved upward, but the sheath abuts the outer side of the aortic arch and cannot transmit movement

Engineering Contradiction:
Improvestent positioning accuracyVSAvoidsheath movement capability
Core Design Contradiction:
Manufacturing precisionVSEase of operation

Solution Approach 1:

The delivery system is divided into separate functional components: the sheath, the core shaft, and the guidewire adjuster. The guidewire adjuster can be independently operated to move the guidewire relative to the sheath, allowing stent position adjustment without requiring sheath movement. This segmentation resolves the contradiction by providing an alternative adjustment mechanism that avoids the sheath locking issue in the aortic arch.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The guidewire acts as an intermediary element between the operator and the stent. By adjusting the guidewire position through the guidewire adjuster, the stent can be moved upward without directly moving the sheath. This intermediary approach allows position adjustment while avoiding the sheath's interaction with the aortic arch bending portion.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Productivity

If the stent is deployed in a lower position due to aortic arch geometry, then the delivery procedure is completed, but the clinical results are unsatisfactory and repositioning is impossible

Engineering Contradiction:
Improveprocedure completionVSAvoidstent positioning accuracy
Core Design Contradiction:
ProductivityVSManufacturing precision

Solution Approach 1:

The guidewire adjuster is designed to be operable both before and after stent deployment. This allows the operator to make preliminary position adjustments before releasing the stent, and also to perform corrective adjustments after deployment if the stent ends up in a lower than desired position. This preliminary and post-deployment adjustment capability ensures accurate positioning while maintaining procedure completion.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system allows dynamic adjustment of the guidewire's axial position relative to the sheath through the guidewire adjuster. By changing this parameter (the relative position of guidewire and sheath), the stent position can be adjusted upward even after deployment, transforming a fixed-position problem into a dynamically adjustable system.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS11903853B2Guidewire adjuster and delivery-system control handle
Publication Date: 2024.02.20 VENUS MEDTECH (HANGZHOU) INC
  • US11903853B2 patent drawing
  • US11903853B2 patent drawing
  • US11903853B2 patent drawing

AI summary

The present invention provides a guidewire adjuster and a delivery-system control handle provided with the guidewire adjuster. The guidewire adjuster includes a support mechanism which has a lumen for a guidewire to extend therethrough; and a driving mechanism for driving the guidewire to move back and forth in the lumen. The guidewire adjuster is able to drive the guidewire to move with respect to a sheath of the delivery system. The support mechanism is connected to the control handle of the delivery system and forms a lumen for accommodating the guidewire. A proximal end of the sheath together with the stent can be driven to move upwardly, due to the relative movement between the guidewire and the sheath of the delivery system. Therefore, the position of the stent can be adjusted by advancing the guidewire forward when the stent has been deployed at a lower position than expected.