Bifurcation Stent Delivery Catheter with Guidewire Alignment

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Solution Overview

Problem

Current stent delivery systems for bifurcations in the vasculature face challenges such as high profile and cumbersome delivery, difficulty in aligning the side opening with the side branch ostium, and lack of means to torque the stent into proper rotational position, leading to potential misalignment and trauma to the vessel.

Innovation Solution

A delivery catheter system with a guidewire structure that allows for the alignment of a stent's side hole with the side branch ostium using a guidewire disposed over an inflatable balloon, with a split lumen to constrain the guidewire and prevent entanglement, and radiopaque markers for rotational alignment, enabling proper positioning before stent expansion.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a side branch tube is positioned beneath the stent and over the balloon to align the side hole with the side branch, then alignment accuracy is improved, but the catheter profile increases and becomes more cumbersome

Engineering Contradiction:

Improvealignment accuracyVSAvoidcatheter profile

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The patent removes the side branch tube from the delivery system, replacing it with a guidewire that passes through the side hole of the stent. This extraction of the unnecessary tube component reduces catheter profile and complexity while maintaining alignment functionality through the guidewire's position and radiopaque markers.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces radiopaque markers as an intermediary visual aid to facilitate alignment between the side hole and side branch ostium. These markers serve as mediators that enable precise alignment through fluoroscopic visualization without requiring physical constraints or additional structural components.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of operation

If the distal portion of the side branch tube extends through the side hole to permit guidewire advancement, then guidewire access is improved, but the unconstrained tube interferes with catheter advancement through the vasculature

Engineering Contradiction:

Improveguidewire accessVSAvoidcatheter advancement difficulty

Core Design Contradiction:

Ease of operationVSDevice complexity

Solution Approach 1:

The patent eliminates the side branch tube entirely, allowing the guidewire to pass directly through the side hole of the stent. This removal of the intermediate tube structure eliminates interference with catheter advancement while maintaining guidewire access through the stent's side hole.

Inventive Principle:

Principle #2Taking out (Extraction)

3Device complexity

If no specific approach is provided to prevent guidewire crossing at the bifurcation, then system simplicity is maintained, but misalignment of the side hole with the side branch ostium occurs

Engineering Contradiction:

Improvesystem simplicityVSAvoidalignment accuracy

Core Design Contradiction:

Device complexityVSMeasurement precision

Solution Approach 1:

The patent employs radiopaque markers on the stent and guidewire as visual intermediaries that enable precise alignment to be achieved through fluoroscopic guidance. These markers serve as mediators that provide real-time feedback on relative positions, allowing accurate alignment without complex mechanical constraints.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The radiopaque markers provide visual feedback during the procedure, allowing the operator to observe the relative positions of the guidewire and stent under fluoroscopy and make real-time adjustments to achieve proper alignment before stent deployment.

Inventive Principle:

Principle #23Feedback

4Adaptability or versatility

If the catheter is advanced through tortuous anatomy with a high profile structure, then delivery capability is maintained, but vessel trauma increases

Engineering Contradiction:

Improvedelivery capabilityVSAvoidvessel trauma

Core Design Contradiction:

Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The patent removes the bulky side branch tube structure from the delivery system, resulting in a lower-profile catheter that can navigate tortuous anatomy more easily. This extraction reduces the catheter's cross-sectional dimensions, improving adaptability to tortuous vessels while reducing mechanical trauma to the vessel wall.

Inventive Principle:

Principle #2Taking out (Extraction)

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

The system facilitates precise alignment and expansion of stents at bifurcations with reduced profile, minimizing vessel trauma and ensuring accurate placement of the side opening with the ostium, even in tortuous anatomy.

Implementation Method 1

radiopaque markers for rotational alignment

Methodology Applied

Scientific EffectX-ray reflection: Reflection

Implementation Method 2

an expandable prosthesis is mounted over the expansion member

Methodology Applied

Scientific EffectElastic expansion: Elasticity

Data Source

PatentUS9339402B2Apparatus and methods for delivering prostheses to luminal bifurcations

Publication Date: 2016.05.17 TRIREME MEDICAL INC

AI summary

A catheter for delivering luminal prostheses comprises a catheter body having an expandable member near a distal end. The prosthesis has a side hole, and a guidewire extends beneath a proximal portion of the prosthesis and over the exterior of the expandable member. A distal end of the guidewire is retracted proximally from the closest point on the side opening to reduce possible interference with catheter advancement.