Catheter Tip Confirmation via Fiber Optic Backscattering

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Solution Overview

Problem

Current tip confirmation systems for placing peripherally inserted central catheters (PICCs) lack precision, often requiring trained professionals and expose patients to radiation, and are less effective in pediatric patients due to deviation of the catheter tip from the intended path, leading to potential complications like arrhythmia and thrombosis.

Innovation Solution

A system and method using a fiber optic cable with a radiation source and detector to transmit and measure electromagnetic radiation, determining the location of the catheter tip relative to the cavoatrial junction by calculating the ratio of backscattered radiation at different wavelengths, 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 the location of the catheter tip can be determined, but the patient is 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 fiber optic cables. The fiber optic cable transmits light from a radiation source through the catheter, and a detector measures the backscattered light to determine catheter tip location, eliminating ionizing radiation exposure while maintaining measurement capability

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

Solution Approach 2:

The patent introduces fiber optic cables as an intermediary medium between the radiation source and the catheter tip. The fiber optic cable guides light to the tip and collects backscattered light, serving as a non-radiative intermediary that enables location determination without direct radiation exposure to the patient

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If conventional tip confirmation systems are used, then catheter placement can be monitored, but the systems require specialized equipment and trained professionals

Engineering Contradiction:
Improvecatheter tip location monitoringVSAvoidspecialized equipment and training requirements
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent creates a multi-functional system where the fiber optic cable serves multiple purposes: it transmits light to the catheter tip, collects backscattered light, and enables location determination. This universal approach integrates multiple functions into a single system, reducing the need for specialized separate equipment and simplifying the overall process

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Manufacturing precision

If the catheter tip is advanced too far, then the tip may reach the desired location, but the tip may contact the heart wall causing arrhythmia or tachycardia

Engineering Contradiction:
Improvecatheter tip placement precisionVSAvoidheart wall damage and arrhythmia risk
Core Design Contradiction:
Manufacturing precisionVSObject-affected harmful factors

Solution Approach 1:

The patent implements a feedback mechanism where the detector continuously measures the backscattered light intensity, which changes as the catheter tip approaches the cavoatrial junction. This real-time feedback allows the operator to monitor the catheter's position and stop advancement before the tip contacts the heart wall, preventing arrhythmia while achieving precise placement

Inventive Principle:
Principle #23Feedback

4Object-affected harmful factors

If the catheter tip is not advanced far enough, then the risk of heart wall contact is reduced, but the patient may be exposed to increased risk of thrombosis or catheter dysfunction

Engineering Contradiction:
Improveheart wall contact riskVSAvoidcatheter functionality and thrombosis risk
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The feedback mechanism from backscattered light measurements provides real-time information about the catheter tip's proximity to the cavoatrial junction. This enables the operator to advance the catheter to the optimal position that prevents heart wall contact while ensuring sufficient placement to avoid thrombosis and maintain catheter functionality

Inventive Principle:
Principle #23Feedback

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 placement of the catheter tip near the cavoatrial junction, reducing the risk of complications and improving safety by eliminating the need for radiation-based methods, while being suitable for pediatric patients.

Implementation Method 1

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 2

measuring an intensity of backscattered electromagnetic radiation

Methodology Applied
Scientific EffectBackscattering: Scattering

Data Source

PatentUS10973586B2Systems and methods of determining one or more properties of a catheter and a distal tip thereof
Publication Date: 2021.04.13 VERUM TCS LLC
  • US10973586B2 patent drawing
  • US10973586B2 patent drawing
  • US10973586B2 patent drawing

AI summary

Tip confirmation systems and related methods are disclosed. A method of determining one or more properties of a catheter 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.