Double-Sided Guidewire Retrograde Antegrade Recanalization

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Solution Overview

Problem

Current methods for recanalizing chronic total occlusions (CTOs) in coronary arteries are complex and often fail due to the inability to successfully pass a guidewire across the lesion, leading to procedural challenges and high referral rates to bypass surgery or medical treatment.

Innovation Solution

A novel double-sided guidewire system is introduced, where a first guidewire is advanced in a retrograde direction to penetrate the occlusion and then coupled with a second guidewire, allowing for antegrade traversal and recanalization, with features such as tapered cross-sectional areas and hydrophilic coatings for enhanced navigation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional guidewires are used to penetrate dense plaque in CTO recanalization, then the guidewire may successfully cross the lesion, but the risk of vessel wall puncture increases due to the stiff resistance offered by dense plaque

Engineering Contradiction:

Improvesuccess rate of guidewire crossingVSAvoidrisk of vessel wall puncture

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The guidewire is divided into multiple segments with different properties: a stiff proximal section for penetrating dense plaque and a flexible distal section for safe navigation through vessels. This segmentation allows the wire to provide sufficient pushing force to cross chronic total occlusions while the flexible tip reduces the risk of accidental vessel wall puncture during manipulation

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different sections of the guidewire have different mechanical properties tailored to specific functions. The proximal portion has high rigidity for force transmission and plaque penetration, while the distal tip has low rigidity for safe navigation. This local differentiation of properties allows the single device to simultaneously achieve reliable crossing and minimize harm

Inventive Principle:

Principle #3Local quality

2Strength

If rigid guidewires are used to push through dense plaque, then penetration capability is improved, but the complexity of the procedure increases and additional personnel are required for backup support

Engineering Contradiction:

Improvepenetration capability through plaqueVSAvoidprocedural complexity and personnel requirements

Core Design Contradiction:

StrengthVSDevice complexity

Solution Approach 1:

The guidewire incorporates a dynamic structure with varying flexibility along its length, allowing it to adapt to different mechanical demands. The proximal stiff section provides necessary strength for plaque penetration, while the distal flexible section allows easy manipulation and navigation, reducing the need for additional backup support devices and personnel

Inventive Principle:

Principle #15Dynamics

3Reliability

If alternate recanalization strategies such as subintimal tracking or retrograde approach are used for challenging CTOs, then guidewire passage may be achieved, but the procedural complexity and time required increase significantly

Engineering Contradiction:

Improveability to pass guidewire across lesionVSAvoidprocedural time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The guidewire is pre-configured with optimal mechanical properties (stiff proximal section, flexible distal tip) before the procedure, allowing immediate effective engagement with the occlusion. This preliminary preparation eliminates the need for time-consuming technique changes or additional devices that would be required with alternate strategies like subintimal tracking or retrograde approaches

Inventive Principle:

Principle #10Preliminary action

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 simplifies the recanalization process by effectively penetrating dense plaque and reducing the risk of vessel wall puncture, improving success rates and reducing procedural complexity.

Implementation Method 1

an outer surface of the first or second guidewire is coated with a hydrophilic coating for ease of navigation through tortuous passageways

Methodology Applied

Scientific EffectHydrophilic coating: Hydrophile

Data Source

PatentUS10786656B2Methods and devices for recanalization of occluded body vessels using a double-sided guidewire

Publication Date: 2020.09.29 ASAHI MEDICAL TECH INC

AI summary

Devices and methods for recanalization of occluded body vessels using novel guidewires. A novel double-sided guidewire comprises a cross-section tapering from a more rigid middle section towards more flexible head sections. A first head of the guidewire is inserted into the occluded body vessel in a retrograde direction to traverse an occlusion. The guidewire is further advanced in the retrograde direction such that the first head and a portion of the middle section are retrieved from the body, thereby positioning the remainder of the guidewire traversing the occlusion in an antegrade direction and allowing for over the wire recanalization techniques in the antegrade direction.