Fiber Optic Catheter Malposition Detection in the Azygos Vein

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Solution Overview

Problem

Existing electromagnetic tracking systems for medical devices are prone to interference from consumer electronics, suffer from signal dropouts, and have limited depth range, posing risks from radiation and contrast media exposure.

Innovation Solution

A fiber optic shape sensing system with a multi-core optical fiber and reflective gratings to determine the trajectory and shape of medical instruments, combined with ECG monitoring, impedance/conductance sensing, and blood flow detection, to detect malposition within a patient's vasculature.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If fluoroscopic methods are used for tracking medical devices, then tip localization accuracy is improved, but patient and clinician exposure to harmful X-ray radiation and contrast media increases

Engineering Contradiction:
Improvetip localization accuracyVSAvoidX-ray radiation exposure
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent replaces electromagnetic tracking systems with an optical tracking system that uses a camera to capture images of reflective markers attached to the medical device. This substitution eliminates the need for electromagnetic fields and their associated interference problems while providing radiation-free tracking with sufficient precision for medical applications.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces reflective markers as intermediaries between the medical device and the camera system. These markers reflect light from an external source back to the camera, enabling optical tracking without requiring the medical device itself to emit or detect electromagnetic signals, thus avoiding radiation exposure and electromagnetic interference.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If electromagnetic tracking systems are used to avoid radiation exposure, then harmful radiation exposure is reduced, but the systems become prone to interference from consumer electronics and signal dropouts

Engineering Contradiction:
Improveradiation exposureVSAvoidtracking signal stability
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent replaces electromagnetic field-based tracking with an optical imaging system that uses a camera to detect reflective markers. This substitution eliminates susceptibility to electromagnetic interference from consumer electronics and other electromagnetic sources, providing a more reliable tracking signal that is not prone to dropouts or interference.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent creates a visual copy or representation of the medical device's position by attaching reflective markers that reflect light back to the camera. This optical copying mechanism provides a stable, interference-free signal that accurately represents the device's location without relying on electromagnetic fields that can be disrupted by external sources.

Inventive Principle:
Principle #26Copying

3Length of stationary object

If electromagnetic tracking systems are used for deep vessel tracking, then tracking capability is provided, but the depth range is limited and signal strength decreases

Engineering Contradiction:
Improvetracking depth rangeVSAvoidsignal strength
Core Design Contradiction:
Length of stationary objectVSReliability

Solution Approach 1:

The patent employs periodic illumination using a light source that emits light in a controlled manner to illuminate reflective markers at various depths. This periodic action allows the camera to capture reflected light from markers throughout the vessel, providing reliable tracking signals even at greater depths where continuous illumination would be insufficient.

Inventive Principle:
Principle #19Periodic action

Solution Approach 2:

The patent utilizes reflective markers that reflect light back to the camera, creating a visual signal that can be detected regardless of depth. The reflective properties of these markers ensure that sufficient light returns to the camera even from deep within the vasculature, maintaining signal strength and reliability across extended depth ranges.

Inventive Principle:
Principle #32Color 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

Provides accurate, radiation-free tracking of medical devices, minimizing interference and signal dropouts, and ensuring precise placement by analyzing strain-induced wavelength shifts in reflected light.

Implementation Method 1

analyzing strain-induced wavelength shifts in reflected light

Methodology Applied
Scientific EffectStrain-induced wavelength shift: Photoelasticity

Implementation Method 2

A fiber optic shape sensing system with a multi-core optical fiber

Methodology Applied
Scientific EffectOptical fiber transmission: Optical Fibre

Implementation Method 3

reflective gratings to determine the trajectory and shape of medical instruments

Methodology Applied
Scientific EffectLight reflection: Reflection

Data Source

PatentUS20250375249A1Malposition Detection System
Publication Date: 2025.12.11 BARD ACCESS SYSTEMS INC
  • US20250375249A1 patent drawing
  • US20250375249A1 patent drawing
  • US20250375249A1 patent drawing

AI summary

A system, apparatus and method directed to detecting malposition of a medical device within a vessel of a patient, such as an Azygos vein. The medical device can include a multi-core optical fiber including a plurality of core fibers, where each of the plurality of core fibers includes a plurality of sensors is configured to reflect a light signal based on received incident light, and change a characteristic of the reflected light signal for use in determining a physical state of the multi-core optical fiber. The system can include a console having non-transitory computer-readable medium storing logic that, when executed, causes operations of providing a broadband incident light signal to the multi-core optical fiber, receiving reflected light signals, processing the reflected light signals, and determining whether the medical device has entered the Azygos vein of the patient based on the reflected light signals.