Flexible-tip stylet with ECG and Doppler sensors

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Solution Overview

Problem

The placement of intravascular catheters is labor-intensive and requires multiple X-ray images, exposing patients to radiation and increasing costs and time.

Innovation Solution

A flexible-tip stylet equipped with an ECG electrode and an ultrasonic transducer, which uses ECG and Doppler signals to guide the catheter placement, reducing the need for X-ray imaging.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If a rigid tip design is used in sensor-equipped stylets, then structural strength and sensor stability are improved, but vessel wall damage increases during catheter insertion

Engineering Contradiction:

Improvetip structural strengthVSAvoidvessel wall damage

Core Design Contradiction:

StrengthVSObject-affected harmful factors

Solution Approach 1:

The stylet tip is divided into multiple segments with different material properties: a proximal rigid segment for structural support and sensor mounting, and a distal flexible segment for vessel wall compatibility. This segmentation allows each portion to perform its specific function optimally without compromising the other.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The stylet tip employs composite construction combining rigid materials (stainless steel or cobalt-chromium alloy) for the proximal portion with flexible materials (nitinol or polymer coatings) for the distal portion. This composite approach enables simultaneous achievement of structural strength and biocompatibility.

Inventive Principle:

Principle #40Composite materials

2Measurement precision

If traditional X-ray imaging is used for catheter tip location confirmation, then placement accuracy is improved, but patient radiation exposure and procedure time increase

Engineering Contradiction:

Improvecatheter tip location accuracyVSAvoidpatient radiation exposure

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical X-ray imaging system with an intravascular sensor system that uses electrical signals (ECG electrodes) and acoustic signals (Doppler flow sensors) to detect catheter tip location. This substitution eliminates radiation exposure while maintaining or improving placement accuracy through real-time signal feedback.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The stylet acts as an intermediary carrier, integrating multiple sensing functions (ECG electrodes, Doppler sensors, and electrical conductors) within its structure. This intermediary device enables non-radiation-based location confirmation by mediating between the catheter tip and external detection systems.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Reliability

If multiple wires are used in the electrical conductor, then electrical signal transmission reliability is improved, but flexibility of the stylet tip decreases

Engineering Contradiction:

Improveelectrical signal transmission reliabilityVSAvoidstylet tip flexibility

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The electrical conductor is segmented into different configurations along its length: multiple parallel wires in the proximal portion for high signal reliability, transitioning to fewer wires or alternative conductor designs in the distal portion to maximize flexibility. This segmentation allows optimization of both electrical performance and mechanical flexibility in different regions.

Inventive Principle:

Principle #1Segmentation

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 solution minimizes vessel damage, reduces patient radiation exposure, and decreases the time and cost associated with catheter placement by eliminating the need for X-ray confirmation.

Implementation Method 1

a stylet equipped with an electrocardiogram ('ECG') sensor (e.g., an ECG electrode)

Methodology Applied

Scientific EffectElectrocardiogram signal detection: Electrical Impedance Tomography

Implementation Method 2

a Doppler sensor (e.g., an ultrasonic transducer) may be used to confirm the tip location of an intravascular catheter

Methodology Applied

Scientific EffectDoppler effect: Doppler Effect

Implementation Method 3

an ultrasound sensor disposed at a distal end of the ring electrode

Methodology Applied

Scientific EffectUltrasonic detection: Ultrasound

Data Source

PatentUS12295717B2Intravascular sensing devices having flexible tip structure

Publication Date: 2025.05.13 TELEFLEX MEDICAL LLC

AI summary

An intravascular device, such as a stylet or catheter, having a flexible, atraumatic tip is disclosed. The intravascular device includes an elongate member having a proximal end, a distal end, and an inner lumen extending between the proximal end and the distal end; a ring electrode disposed at the distal end of the elongate member; an ultrasound sensor disposed at a distal end of the ring electrode; and a first electrical conductor configured to convey an electrocardiogram signal from the ring electrode to a processor. The first electrical conductor may comprise a tapered distal segment or a braided segment.