Guiding Sheath with Flexible Distal Tip for Carotid Access

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Solution Overview

Problem

Current methods face significant challenges in accessing and treating cerebral vascular conditions via a radial artery approach, due to the difficulty in navigating devices through the aortic arch and subclavian arteries to reach the carotid arteries.

Innovation Solution

A guiding sheath system comprising a dilator with an inner guide wire cavity and a sheath with a flexible distal end, both featuring shape-imparted portions to facilitate insertion into the carotid artery, enhancing torque transmission and reducing the risk of blood vessel perforation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Power

If the sheath main body portion is made hard to provide high torque transmission performance, then torque transmission is improved, but the risk of blood vessel perforation increases

Engineering Contradiction:
Improvetorque transmission performanceVSAvoidrisk of blood vessel perforation
Core Design Contradiction:
PowerVSObject-affected harmful factors

Solution Approach 1:

The sheath is designed with different material properties in different regions: the sheath main body portion is made of a harder material to provide high torque transmission performance, while the sheath distal end portion is made of a more flexible material to reduce the risk of blood vessel perforation. This local differentiation of material properties allows each region to perform its specific function optimally without compromising the other.

Inventive Principle:
Principle #3Local quality

2Ease of operation

If the device is rapidly curved in the aortic arch to reach the carotid artery, then access to the carotid artery is achieved, but the difficulty of navigation increases

Engineering Contradiction:
Improveease of indwellingVSAvoiddifficulty of navigation
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

A shape-imparted portion is provided on at least one of the dilator distal end portion and the sheath distal end portion to which a specific shape is imparted in advance. This pre-formed shape facilitates the device's navigation through the aortic arch and into the carotid artery, reducing the complexity of the navigation process and making the indwelling operation easier.

Inventive Principle:
Principle #10Preliminary action

3Object-affected harmful factors

If the sheath distal end portion is made flexible to reduce blood vessel perforation risk, then safety is improved, but torque transmission performance deteriorates

Engineering Contradiction:
Improverisk of blood vessel perforationVSAvoidtorque transmission performance
Core Design Contradiction:
Object-affected harmful factorsVSPower

Solution Approach 1:

The sheath is designed with different material properties in different regions: the sheath main body portion is made of a harder material to provide high torque transmission performance, while the sheath distal end portion is made of a more flexible material to reduce the risk of blood vessel perforation. This local differentiation of material properties allows each region to perform its specific function optimally without compromising the other.

Inventive Principle:
Principle #3Local quality

4Ease of operation

If a shape-imparted portion is added to facilitate insertion, then ease of indwelling is improved, but device complexity increases

Engineering Contradiction:
Improveease of insertionVSAvoidstructural complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

A shape-imparted portion is provided on at least one of the dilator distal end portion and the sheath distal end portion to which a specific shape is imparted in advance. This pre-formed shape facilitates the device's navigation through the aortic arch and into the carotid artery, reducing the complexity of the navigation process and making the indwelling operation easier.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS20250073428A1Guiding sheath
Publication Date: 2025.03.06 TERUMO KK
  • US20250073428A1 patent drawing
  • US20250073428A1 patent drawing
  • US20250073428A1 patent drawing

AI summary

A guiding sheath, which is capable of causing a dilator and a sheath to integrally reach a carotid artery which is accessed from a radial artery and communicates with a target treatment site, and easily indwelling the sheath in the carotid artery that communicates with the target treatment site. The guiding sheath includes: a dilator in which an inner cavity, through which a guide wire is insertable is provided, over an entire length of the dilator and which includes a dilator distal end portion and a dilator main body portion; and a sheath which covers outside of the dilator and includes a sheath distal end portion and a sheath main body portion. The sheath distal end portion is disposed on a distal end side of the sheath main body portion and is formed of a material more flexible than a material forming the sheath main body portion.