Variable Flexibility Catheter for True Lumen Re-entry

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Solution Overview

Problem

Current medical devices face challenges in consistently and reliably redirecting subintimally advanced guidewires back into the true lumen of arteries for treating chronic total occlusions, particularly due to the difficulty in penetrating hard, calcified plaque and maintaining stability within tortuous and irregularly shaped arteries.

Innovation Solution

The occlusion bypassing apparatus features an outer shaft with lateral balloons for stabilization, an inner shaft with variable flexibility, and a needle component with a curved distal end that can be deployed through a side port to re-enter the true lumen, allowing for precise guidance and anchoring within the subintimal space.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If a stiff guidewire is used to penetrate hard calcified plaque, then the ability to cross the occlusion is improved, but the risk of deviating into subintimal tract increases

Engineering Contradiction:

Improveguidewire penetration capabilityVSAvoidguidewire trajectory control

Core Design Contradiction:

StrengthVSReliability

Solution Approach 1:

The guidewire is divided into multiple segments with different flexibility characteristics. The proximal portion has higher flexibility to follow the true lumen path, while the distal portion has lower flexibility to penetrate the occlusion, allowing both trajectory control and penetration capability

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different portions of the guidewire have different mechanical properties tailored to their specific functions. The proximal segment is more flexible for navigation, while the distal segment is stiffer for penetration, optimizing performance at each location along the wire

Inventive Principle:

Principle #3Local quality

2Adaptability or versatility

If a flexible catheter is used to navigate tortuous arteries, then the ability to reach the treatment site is improved, but the stability and control during the procedure decreases

Engineering Contradiction:

Improvecatheter navigation capabilityVSAvoidcatheter positional stability

Core Design Contradiction:

Adaptability or versatilityVSStability of the object's composition

Solution Approach 1:

The catheter is constructed with multiple segments or zones of varying flexibility. The proximal portion is more flexible to navigate tortuous anatomy, while the distal portion is stiffer to provide stability for needle deployment and guidewire control

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different sections of the catheter have different mechanical properties optimized for their specific functions. The proximal section accommodates anatomical tortuosity while the distal section maintains positional stability during the recanalization procedure

Inventive Principle:

Principle #3Local quality

3Device complexity

If a needle component with fixed curvature is used to reenter the true lumen, then the device structure is simplified, but the ability to adapt to varying arterial geometries decreases

Engineering Contradiction:

Improveneedle structure simplicityVSAvoidneedle trajectory adaptability

Core Design Contradiction:

Device complexityVSAdaptability or versatility

Solution Approach 1:

The needle component's curvature is made adjustable rather than fixed. The needle can be dynamically repositioned or reconfigured to match different arterial geometries and target locations, allowing adaptation to varying anatomical conditions while maintaining a relatively simple overall device structure

Inventive Principle:

Principle #15Dynamics

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 apparatus effectively navigates the guidewire back into the true lumen, facilitating successful recanalization and treatment of chronic total occlusions by providing stability and precise navigation through the use of lateral balloons and a flexible needle component.

Implementation Method 1

The transition portion has a variable flexibility along its length that decreases in a distal direction

Methodology Applied

Scientific EffectVariable flexibility: Elasticity

Implementation Method 2

The needle housing includes a curved distal portion that bends from the longitudinal axis of the apparatus and terminates at the side port of the outer shaft component

Methodology Applied

Scientific EffectCurved geometry: Geometry

Data Source

PatentUS10456557B2Occlusion bypassing apparatus with varying flexibility and methods for bypassing an occlusion in a blood vessel

Publication Date: 2019.10.29 INVATEC

AI summary

An occlusion bypassing apparatus is disclosed for re-entering the true lumen of a vessel after subintimally bypassing an occlusion in a vessel. The apparatus includes an outer shaft component, an inner shaft component disposed within the outer shaft component, and a needle component slidably disposed within the inner shaft component. The inner shaft component includes a body portion and a needle housing, which is distal to the body portion. The needle housing is less flexible than the body portion. In order to smooth the transition between the body portion and the needle housing, the needle housing includes a transition portion that has a variable flexibility along its length that decreases in a distal direction. A curved distal end of the needle component is distally advanced relative to the inner shaft component to pierce through the intima of the vessel and thereafter enter the true lumen.