Looped Crossing Wire for Chronic Total Occlusion

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Solution Overview

Problem

Existing CTO crossing devices have a high failure rate and are too large for use below the waist, leading to prolonged procedures, increased radiation exposure, and complications such as vessel perforation and dissection, especially in patients with peripheral artery disease.

Innovation Solution

A crossing wire with a loop configuration at its distal end, designed to prevent excessive width and maintain alignment with the vessel wall, featuring a rectangular cross-section and varying stiffness along its length, allowing for effective interrogation and erosion of lesions without causing vessel rupture.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If existing CTO crossing devices are used, then crossing capability is achieved, but device size is too large for use below the waist

Engineering Contradiction:

Improvedevice sizeVSAvoidcrossing capability

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The crossing device is divided into multiple components: a catheter, a crossing wire with loop configuration, and optionally a balloon. This segmentation allows the device to be delivered through smaller vasculature while maintaining crossing capability. The looped wire can be inserted through the catheter and manipulated independently to cross the occlusion, then the balloon can be advanced through the same access for treatment.

Inventive Principle:

Principle #1Segmentation

2Productivity

If existing CTO crossing devices are used, then crossing procedure is performed, but procedural time is prolonged

Engineering Contradiction:

Improveprocedural timeVSAvoidcrossing success rate

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The crossing wire is pre-formed with a loop configuration at its distal end before insertion. This preliminary shaping allows the wire to immediately engage with the occlusion upon deployment, eliminating the need for time-consuming manipulation and shaping during the procedure. The loop is ready to interrogate and cross the lesion right from the start.

Inventive Principle:

Principle #10Preliminary action

3Reliability

If existing CTO crossing devices are used, then crossing attempt is made, but radiation exposure increases

Engineering Contradiction:

Improvecrossing success rateVSAvoidradiation exposure

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device incorporates radiopaque elements that appear bright under fluoroscopic imaging, allowing real-time visualization of the catheter, wire, and balloon without requiring excessive radiation exposure. The radiopaque markers enable the operator to track device position and confirm successful crossing with minimal radiation dose.

Inventive Principle:

Principle #32Color changes

4Reliability

If existing CTO crossing devices are used, then crossing procedure is performed, but vessel perforation and dissection occur

Engineering Contradiction:

Improvecrossing capabilityVSAvoidvessel damage

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The loop configuration of the crossing wire inherently cushions the interaction with the vessel wall and occlusion. The loop's geometry distributes contact forces along its arc rather than concentrating them at a single point, reducing the risk of vessel perforation or dissection during the crossing maneuver.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

5Measurement precision

If crossing wire with loop configuration is used, then lesion interrogation is improved, but device complexity increases

Engineering Contradiction:

Improvelesion interrogation capabilityVSAvoidwire configuration

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The crossing wire features a simple loop configuration at its distal end, forming a curved geometric shape that naturally conforms to the vessel wall and occlusion geometry. This curved loop provides stable contact and effective lesion interrogation through its geometric shape alone, without requiring complex mechanical or electronic components.

Inventive Principle:

Principle #14Spheroidality (Curvature)

Data Source

PatentUS12004772B2Chronic total occlusion crossing devices and methods

Publication Date: 2024.06.11 MUSTAPHA JIHAD A

AI summary

A device for crossing a lesion in a tissue lumen includes a crossing wire configured to pass through a lumen of a catheter, the crossing wire including a loop at a distal end of the crossing wire. The loop can have a configuration that prevents a width of the loop from exceeding a width of the tissue lumen, and the loop having a pair of lateral opposing portions configured for alignment with a wall of the tissue lumen and a leading portion interconnecting the pair of lateral opposing portions, the leading portion being configured to interrogate the lesion. The loop has a length in an axial direction of the crossing wire extending from the leading portion to proximal ends of the pair of lateral opposing portions, the length being perpendicular to the width, and the length of the loop is at least twice the width of the loop.