Sheathless Dilator for Radial Artery Access

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Solution Overview

Problem

Transradial catheterization faces challenges such as radial artery spasm, pain, and occlusion due to the smaller diameter of the radial artery, which limits the use of larger guide catheters and increases the risk of complications like iatrogenic occlusion, and existing sheathless systems are costly and restrictive in terms of catheter size and shape.

Innovation Solution

A dilator with a tubular distal member and a proximal member featuring a skived portion and a rapid exchange port, allowing for sheathless access and facilitating the use of larger guide catheters by avoiding the need for a sheath, while maintaining flexibility and pushability to navigate the vasculature.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a sheath is employed in the catheterization procedure, then the guide catheter can be delivered through the access site, but the outer diameter of the sheath increases the stretching and expansion of the radial artery, leading to spasm, pain, and occlusion

Engineering Contradiction:

Improveguide catheter deliveryVSAvoidradial artery spasm and occlusion

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent removes the sheath component from the catheterization system, allowing the guide catheter to be delivered directly through the radial artery without the intermediate sheath. This extraction of the sheath eliminates the source of excessive stretching and expansion that causes radial artery spasm and occlusion, while still enabling guide catheter delivery through the access site.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

Instead of delivering the guide catheter through a sheath (conventional approach), the patent inverts the sequence by delivering the guide catheter directly through the radial artery without a sheath. This inversion of the traditional sheath-based delivery system resolves the contradiction by eliminating the harmful effects of the sheath while maintaining the ability to deliver the guide catheter.

Inventive Principle:

Principle #13The other way round (Inversion)

2Ease of operation

If a 6 French or larger sheath is used for radial catheterization, then the guide catheter can be delivered, but the risk of radial artery occlusion increases significantly

Engineering Contradiction:

Improveguide catheter deliveryVSAvoidradial artery patency

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The patent extracts the sheath from the system entirely, allowing direct delivery of the guide catheter through the radial artery. This eliminates the sheath-related risk of radial artery occlusion while maintaining the capability to deliver guide catheters of various sizes, thereby improving radial artery patency without sacrificing delivery capability.

Inventive Principle:

Principle #2Taking out (Extraction)

3Object-affected harmful factors

If conventional sheathless systems are used, then the entry hole size is reduced, but the systems are expensive and require a new system with each guide catheter exchange

Engineering Contradiction:

Improveentry hole sizeVSAvoidsystem configuration requirements

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent creates a sheathless system where the guide catheter itself serves the function of both access and delivery without requiring a separate sheath or specialized system components. The guide catheter is designed with features that enable direct radial artery puncture and navigation, making the system self-sufficient and eliminating the need for expensive proprietary sheathless systems or multiple system configurations.

Inventive Principle:

Principle #25Self-service

4Object-affected harmful factors

If conventional sheathless systems are used, then radial artery trauma is reduced, but the choice of catheter size and shape is limited

Engineering Contradiction:

Improveradial artery traumaVSAvoidcatheter size and shape selection

Core Design Contradiction:

Object-affected harmful factorsVSAdaptability or versatility

Solution Approach 1:

The patent designs a universal sheathless guide catheter that can be used for various catheter sizes and configurations without requiring specialized systems. The guide catheter incorporates multi-functional features that enable direct radial artery access, navigation, and support for different interventional procedures, providing versatility in catheter selection while maintaining reduced radial artery trauma through the sheathless approach.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Data Source

PatentUS11291810B2Rapid exchange dilator for sheathless catheterization

Publication Date: 2022.04.05 CORDIS US CORP

AI summary

A dilator for sheathless access to a vessel of a patient having a tubular distal member with a skived portion on the proximal end and a proximal member with a skived portion on the distal end. The respective skived portions overlap at a transition region and form a rapid exchange port that communicates with the lumen of the distal member. The proximal member and the distal member may be secured together with transition tubing that is coaxially disposed over the distal and of the proximal member and extends over the skived portion of the distal member within a projected circumference of the distal member.