Optical Catheter Tip Confirmation via Backscattered Light

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Solution Overview

Problem

Current tip confirmation systems for placing peripherally inserted central catheters (PICCs) lack precision, often requiring trained clinicians and exposing patients to radiation, and are less effective in pediatric patients due to deviations in catheter tip placement, leading to risks of arrhythmia, thrombosis, and medicament concentration issues.

Innovation Solution

A system utilizing a fiber optic cable with a radiation source and detector to transmit and measure electromagnetic radiation, calculating a ratio of backscattered radiation at different wavelengths to determine the catheter tip's location relative to the cavoatrial junction, allowing for precise placement without radiation exposure and suitable for pediatric patients.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If fluoroscopic dyes and fluoroscopy are used for tip confirmation, then catheter tip location can be determined, but patients are exposed to harmful ionizing radiation

Engineering Contradiction:
Improvecatheter tip location determinationVSAvoidionizing radiation exposure
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical/radiation-based fluoroscopy system with an optical system using light-emitting diodes (LEDs) and photodetectors. The optical catheter tip confirmation system uses light transmission through the catheter wall and detection of light intensity changes to determine tip location, eliminating ionizing radiation exposure while maintaining measurement precision.

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

Solution Approach 2:

The patent introduces an optical intermediary system where light serves as the mediator between the catheter and the detection system. The LED emits light that passes through the catheter wall, and the photodetector detects the transmitted light, creating an optical signal chain that replaces the direct radiation-based detection method.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

If conventional tip confirmation systems are used, then catheter placement can be monitored, but placement precision is insufficient for pediatric patients

Engineering Contradiction:
Improvecatheter placement efficiencyVSAvoidcatheter tip placement accuracy
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The patent applies local quality by making the catheter itself optically active with integrated LEDs and photodetectors at specific locations. The distal end of the catheter contains the light source and detector assembly, creating localized measurement capability that provides precise tip location feedback specific to the catheter's actual position in the vasculature.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent implements a feedback system where the photodetector continuously monitors light intensity changes as the catheter moves through the vasculature. The system provides real-time feedback about tip location and depth, allowing clinicians to adjust catheter position to achieve optimal placement precision, particularly important for pediatric patients with smaller vasculature.

Inventive Principle:
Principle #23Feedback

3Ease of operation

If manual catheter advancement is performed, then catheter insertion can be completed, but tip placement precision requires highly trained clinicians

Engineering Contradiction:
Improvecatheter insertion processVSAvoidcatheter tip location accuracy
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The patent enables the catheter to self-monitor its own position through integrated optical sensors and LEDs. The catheter automatically detects changes in light intensity as it moves through different anatomical locations and provides self-reporting of tip location, eliminating the need for external radiation-based monitoring systems and reducing dependence on clinician expertise.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent replaces manual clinical judgment and radiation-based imaging with an automated optical sensing system. The electronic detection and processing of light intensity changes provides objective, quantitative feedback about catheter tip location, replacing the subjective assessment required by trained clinicians and improving placement precision.

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

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

Enables precise and safe placement of PICC tips near the cavoatrial junction, reducing the risk of complications and improving placement accuracy in both adult and pediatric patients by eliminating the need for radiation-based methods.

Implementation Method 1

transmitting source electromagnetic radiation having at least a first substantially monochromatic wavelength and electromagnetic radiation having at least a second substantially monochromatic wavelength from the radiation source to a distal end of the at least one optical fiber

Methodology Applied
Scientific EffectElectromagnetic radiation transmission: Light

Implementation Method 2

a fiber optic cable comprising at least one optical fiber coupled to a radiation source and a detector

Methodology Applied
Scientific EffectOptical fiber transmission: Optical Fibre

Implementation Method 3

measuring an intensity of backscattered electromagnetic radiation at the at least a first substantially monochromatic wavelength and at the at least a second substantially monochromatic wavelength

Methodology Applied
Scientific EffectBackscattering: Scattering

Data Source

PatentEP3405099B1Systems of determining one or more properties of a catheter and a distal tip thereof
Publication Date: 2024.11.06 VERUM TCS LLC
  • EP3405099B1 patent drawingFigure 1
  • EP3405099B1 patent drawingFigure 2A
  • EP3405099B1 patent drawingFigure 2B

AI summary

Tip confirmation systems and related methods are disclosed. A method of determining one or more properties of a catheter (200) in a patient comprises advancing a catheter in vasculature of a patient, the catheter coupled to at least one radiation source and at least one detector, transmitting source electromagnetic radiation from the at least one radiation source out of the catheter proximate a distal tip thereof, measuring an intensity of backscattered electromagnetic radiation from the at least one radiation source with the at least one detector, and providing a signal indicative of a location of the distal tip within the vasculature based, at least in part, on the measured intensity of the backscattered electromagnetic radiation. Related systems and methods are also disclosed.