Vascular Catheter Tip Navigation Using Injectate-Based Sensing

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Solution Overview

Problem

Current methods for placing vascular catheters, such as PICCs, are challenging due to the risk of incorrect vein or artery insertion, advancement into incorrect vein branches, placement too close to or into the heart, vessel wall embedding, and reliance on costly and time-consuming x-ray verification, with inaccurate distance estimation to the superior vena cava.

Innovation Solution

The use of a vascular catheter location and navigation system that introduces a medium with a measurable parameter, such as temperature or conductivity, and sensors to track and analyze blood flow characteristics, allowing real-time detection of catheter position using temperature, light reflection, sound reflection, or impedance changes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If physical measurement and distance estimation are used to determine catheter placement, then the procedure is simple and quick, but the placement accuracy is poor and may lead to incorrect positioning

Engineering Contradiction:
Improvecatheter tip location accuracyVSAvoidnavigation system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces the mechanical measurement system (physical tape measurement and distance estimation) with a sensor-based detection system that uses temperature, conductivity, or other measurable parameters to precisely locate the catheter tip in real-time, eliminating the need for complex anatomical measurements while improving accuracy

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

Solution Approach 2:

The patent introduces an intermediary medium (such as a temperature-sensitive fluid or conductive solution) that can be injected near the catheter tip to create a measurable signal, allowing indirect detection of the catheter's exact position without requiring direct visual or mechanical measurement of the tip location

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If x-ray verification is used to confirm catheter placement, then placement accuracy is verified, but the procedure becomes more costly and time-consuming

Engineering Contradiction:
Improvecatheter placement verification accuracyVSAvoidprocedural time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent enables continuous real-time monitoring of catheter position throughout the insertion procedure using sensors that provide ongoing feedback, eliminating the need for intermittent discontinuous x-ray verification and allowing the procedure to proceed without time-consuming imaging breaks

Inventive Principle:
Principle #20Continuity of useful action

Solution Approach 2:

The patent substitutes the x-ray imaging system with a sensor-based detection system that provides real-time electrical or thermal signals indicating catheter position, eliminating the need for repeated radiographic verification while maintaining accurate placement confirmation

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

3Reliability

If traditional blind placement method is used, then the procedure is simple to perform, but the risk of incorrect insertion into arteries or wrong vein branches is high

Engineering Contradiction:
Improvecorrect vein insertion reliabilityVSAvoidplacement procedure simplicity
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent implements a feedback mechanism where sensors continuously monitor parameters such as temperature or conductivity changes in the tissue, providing real-time information to the operator about whether the catheter is in the correct vein, allowing immediate correction if wrong vessel insertion is detected

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent uses an intermediary detection system that senses physiological or physical properties of the surrounding tissue (such as blood flow characteristics or tissue conductivity) to identify the correct vein versus artery or wrong branch, providing indirect but reliable guidance without requiring complex surgical visualization

Inventive Principle:
Principle #24Intermediary (Mediator)

4Reliability

If catheter is advanced without real-time location monitoring, then the procedure is faster, but the risk of advancing too far into the heart or inferior vena cava is increased

Engineering Contradiction:
Improvecatheter tip position controlVSAvoidplacement procedure speed
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The patent provides continuous feedback on catheter tip position relative to anatomical landmarks (such as the cavo-atrial junction) through sensor measurements, allowing the operator to stop advancement at the precise target location without risking over-advancement into the heart or inferior vena cava

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 accurate and real-time navigation of vascular catheters by identifying correct vein placement, avoiding arteries and incorrect vein branches, and detecting proximity to the heart or vessel walls without the need for x-ray verification, thereby reducing procedural risks and costs.

Implementation Method 1

sensing and measuring the measurable parameter as the catheter is advanced within a flowing fluid, such as blood flow in a blood vessel

Methodology Applied
Scientific EffectTemperature measurement:

Implementation Method 2

introduction of a medium (or injectate) with a measurable parameter (temperature, light reflection, sound reflection, conductance, impedance, etc.)

Methodology Applied
Scientific EffectTemperature:

Implementation Method 3

introduction of a medium (or injectate) with a measurable parameter (temperature, light reflection, sound reflection, conductance, impedance, etc.)

Methodology Applied
Scientific EffectLight reflection: Reflection

Implementation Method 4

introduction of a medium (or injectate) with a measurable parameter (temperature, light reflection, sound reflection, conductance, impedance, etc.)

Methodology Applied
Scientific EffectSound reflection: Reflection

Implementation Method 5

introduction of a medium (or injectate) with a measurable parameter (temperature, light reflection, sound reflection, conductance, impedance, etc.)

Methodology Applied
Scientific EffectElectrical conductance: Conduction (electrical)

Data Source

PatentUS12521036B2Devices and methods for vascular navigation, assessment and/or diagnosis
Publication Date: 2026.01.13 PICCOLO MEDICAL INC
  • US12521036B2 patent drawing
  • US12521036B2 patent drawing
  • US12521036B2 patent drawing

AI summary

Devices and methods for vascular navigation, assessment and/or diagnosis are disclosed where a location detection system generally includes an elongate body defining a lumen at least partially along a length of the elongate body. One or more sensors are positioned near or at a distal tip of the elongate body and one or more openings are defined along the elongate body in proximity to the one or more sensors. The one or more openings are configured to control a boundary distance between the one or more sensors and a fluid with a parameter of a known initial value when emitted from the one or more openings. A controller is in communication with the one or more sensors and is configured to track a change in the parameter relating to concentration over the one or more sensors and determine a position of the one or more sensors within a body.