Segmented Carotid Dilator Stiffness for Vascular Access

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Solution Overview

Problem

Current minimally invasive treatment devices, such as carotid sheaths and dilators, face challenges in navigating the tortuous vasculature, particularly in accessing the carotid artery, which can lead to displacement of guidewires and necessitate more invasive procedures like surgical endarterectomy.

Innovation Solution

The use of rapid exchange entry and tracking dilators, which are designed to facilitate advancement of carotid sheaths through tortuous paths by being either stiff for initial entry or soft for navigation, with features like slots for rapid exchange and hydrophilic coatings to reduce friction, minimizing the risk of guidewire displacement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a stiff dilator is used for initial entry into the vasculature, then the ability to access the carotid artery is improved, but the risk of displacing guidewires increases

Engineering Contradiction:

Improveability to access carotid arteryVSAvoidguidewire displacement risk

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The dilator system is divided into multiple segments with different stiffness characteristics. The proximal portion has higher stiffness for initial access, while the distal portion has lower stiffness for safe navigation through tortuous vasculature. This segmentation allows each portion to perform its specific function optimally without compromising the other.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different portions of the dilator are given different mechanical properties (stiffness) according to their specific functional requirements. The proximal portion is made stiffer for penetrating the arterial wall and establishing access, while the distal portion is made softer for safely traversing the tortuous vascular path without displacing guidewires.

Inventive Principle:

Principle #3Local quality

2Reliability

If a soft dilator is used for navigation through tortuous vasculature, then the risk of guidewire displacement is reduced, but the ability to access the carotid artery is compromised

Engineering Contradiction:

Improveguidewire displacement riskVSAvoidability to access carotid artery

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The dilator is segmented into proximal and distal portions with differentiated stiffness. The distal portion is designed to be softer for safe navigation through tortuous vasculature, while the proximal portion provides the necessary stiffness for initial access.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The dilator exhibits local quality variations in stiffness along its length. The distal portion has lower stiffness (softer) to reduce guidewire displacement risk during navigation, while the proximal portion has higher stiffness (stiffer) to enable effective carotid artery access.

Inventive Principle:

Principle #3Local quality

3Device complexity

If a single dilator design is used for both entry and tracking, then device complexity is reduced, but the ability to navigate tortuous paths is limited

Engineering Contradiction:

Improvenumber of dilator typesVSAvoidability to navigate tortuous paths

Core Design Contradiction:

Device complexityVSAdaptability or versatility

Solution Approach 1:

Rather than using multiple separate dilators, the invention segments a single dilator into portions with different stiffness characteristics. This allows one dilator to perform multiple functions (initial access and tortuous path navigation) that would otherwise require different devices.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The dilator is designed with multi-functionality, where a single device can perform both initial vascular access and navigation through tortuous paths. The differentiated stiffness portions enable the same dilator to handle both tasks that would traditionally require separate entry and tracking dilators.

Inventive Principle:

Principle #6Universality (Multi-functionality)

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

Enables successful minimally invasive stenting by ensuring precise placement of carotid sheaths without displacing guidewires, thereby avoiding more invasive procedures and improving the efficiency of vascular treatments.

Implementation Method 1

hydrophilic coatings to reduce friction

Methodology Applied

Scientific EffectHydrophilic coating: Hydrophile

Data Source

PatentUS9302083B2Carotid sheath with entry and tracking rapid exchange dilators and method of use

Publication Date: 2016.04.05 FISCHELL INNOVATIONS LLC

AI summary

Dilators and sheaths for use in minimally invasive vascular therapy are disclosed. In some embodiments, the dilators include a slot that accesses a guidewire lumen within the dilator. These slots facilitate rapid exchange of one dilator for another. In another embodiment, a dilator is sufficiently stiff to facilitate entry, but also designed to facilitate placement of the dilator along a tortuous path.