Multi-lumen Laser Catheter for CTO Penetration

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Solution Overview

Problem

Chronic total occlusions (CTOs) are difficult to treat with conventional vascular catheters due to their calcified and fibrotic nature, which prevents penetration and blocks fluid flow, leading to a low success rate and high risk of blood vessel perforation during treatment.

Innovation Solution

A laser catheter system with multiple lumens allows for the rapid exchange of guidewires and diagnostic devices, enabling safe navigation and penetration of CTOs by alternating between stiff and soft tipped guidewires, and using optical fibers to deliver light energy for ablation, facilitating successful recanalization without requiring contrast agent flow.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional guidewires are used to penetrate CTOs, then the catheter can be advanced to the occlusion site, but the guidewire cannot effectively penetrate the calcified and fibrotic occlusion

Engineering Contradiction:

Improvesuccess rate of CTO penetrationVSAvoiddifficulty of penetrating CTO

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The patent applies parameter changes by modifying the physical properties of the guidewire through laser irradiation. The laser energy changes the temperature and mechanical properties of the guidewire tip, making it softer and more compliant to navigate through the calcified and fibrotic CTO without perforation, thereby resolving the contradiction between penetration capability and safety

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent replaces the purely mechanical pushing force with optical energy (laser) to modify the guidewire properties in situ. This substitution allows dynamic adjustment of guidewire characteristics without physical manipulation, enabling effective CTO penetration while maintaining vessel safety

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Loss of information

If contrast agent is used to visualize guidewire advancement, then fluoroscopy can guide the procedure, but contrast agent cannot flow through complete CTO blockages

Engineering Contradiction:

Improvevisibility of guidewire advancementVSAvoidflow of contrast agent

Core Design Contradiction:

Loss of informationVSQuantity of substance

Solution Approach 1:

The patent replaces the fluid-based contrast agent visualization system with an optical system. The laser catheter incorporates optical fibers that deliver light directly to the guidewire and surrounding tissue, enabling fluorescence or reflective imaging without requiring contrast agent flow through the occluded vessel

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces light as an intermediary medium to replace contrast agent for visualization purposes. The optical fibers transmit light to the treatment site, and the reflected or fluorescent light provides real-time imaging guidance, eliminating the dependency on contrast agent flow

Inventive Principle:

Principle #24Intermediary (Mediator)

3Force

If stiff guidewire tips are used to penetrate CTO, then penetration capability is improved, but the risk of blood vessel perforation increases

Engineering Contradiction:

Improvepenetration force of guidewireVSAvoidrisk of vessel perforation

Core Design Contradiction:

ForceVSObject-affected harmful factors

Solution Approach 1:

The patent applies dynamics by making the guidewire properties changeable during the procedure. The laser irradiation dynamically softens the guidewire tip in real-time, allowing it to be stiff enough for initial penetration but compliant enough to follow vessel contours and avoid perforation, thus resolving the contradiction between penetration force and safety

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The patent changes the physical parameters of the guidewire (temperature, softness, compliance) through laser heating. This parameter change allows the guidewire to adapt its mechanical properties to the specific requirements of each procedure segment, providing penetration capability when needed while minimizing perforation risk

Inventive Principle:

Principle #35Parameter changes

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 significantly increases the success rate of crossing and treating CTOs by allowing precise navigation and energy application, reducing the risk of vessel perforation and improving the ability to create a lumen through the occlusion.

Implementation Method 1

illuminating the occlusion with light emitted from a plurality of optical fibers positioned between the distal lumen and an outside surface of the catheter

Methodology Applied

Scientific EffectOptical fiber light transmission: Optical Fibre

Implementation Method 2

The laser catheter may be activated to create a lumen through the occlusion

Methodology Applied

Scientific EffectLaser ablation: Laser Ablation

Data Source

PatentUS8104483B2Multi-port light delivery catheter and methods for the use thereof

Publication Date: 2012.01.31 SPECTRANETICS CORP

AI summary

Methods of advancing a laser catheter across an occlusion are described. They may include the steps of advancing a guidewire through a first proximal lumen and a distal lumen of the catheter into a first region of the occlusion, retracting the guidewire from the distal lumen, and advancing a diagnostic device from a second proximal lumen of the catheter to examine the occlusion. The methods may also include retracting the diagnostic device from the distal lumen and advancing the guidewire through the distal lumen. The laser catheter may be activated to create a lumen through the occlusion.