Catheter Stylet with Electromagnetic Coil for Tip Positioning
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Solution Overview
Problem
Current catheter placement methods lack accuracy and efficiency, particularly in navigating the catheter through the vasculature and ensuring precise positioning of the catheter tip, often requiring confirmatory X-rays and involving cumbersome processes that increase patient exposure and procedural complexity.
Innovation Solution
An integrated catheter placement system combining ultrasound-assisted guidance, magnetically-based tip location tracking, and ECG signal-based guidance to accurately position the catheter tip within the vasculature, allowing for real-time visualization and correction of tip malposition without the need for X-rays, while maintaining sterility through specialized connector systems.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional catheter placement methods are used, then the procedure can be completed, but the catheter tip positioning accuracy is poor and confirmatory X-rays are required
Solution Approach 1:
The patent replaces mechanical/X-ray-based verification systems with an electromagnetic sensing system. A stylet containing an electromagnetic coil generates a magnetic field that can be detected by external sensors, providing real-time catheter tip location information without requiring ionizing radiation. This substitution eliminates the need for confirmatory X-rays while improving positioning accuracy.
Solution Approach 2:
The patent introduces a stylet as an intermediary component between the catheter and the positioning system. The stylet contains an electromagnetic coil that acts as a mediator, translating the catheter's position into a detectable magnetic signal. This intermediary enables non-invasive, real-time tracking of the catheter tip without exposing the patient to harmful radiation.
2Measurement precision
If multiple separate guidance systems are used for catheter placement, then comprehensive guidance can be provided, but the device complexity and procedural steps increase
Solution Approach 1:
The patent combines multiple guidance functions into a single integrated system. The stylet with the electromagnetic coil integrates positioning, tracking, and guidance capabilities that would otherwise require separate devices. This merging reduces the number of components and simplifies the procedural workflow while maintaining high placement accuracy.
Solution Approach 2:
The stylet serves multiple functions simultaneously: it provides structural support for the catheter, generates the magnetic field for tracking, and enables real-time position detection. This multi-functionality eliminates the need for separate guidance devices, reducing overall system complexity while comprehensive guidance is maintained.
3Measurement precision
If a stylet with electromagnetic coil is used for tracking, then real-time tip location can be detected, but the stylet connection to the console must maintain sterility
Solution Approach 1:
The stylet acts as a sterile intermediary that remains within the sterile field while transmitting positional information to the non-sterile console. The electromagnetic coil on the stylet generates a magnetic field that can be detected wirelessly or through a sterile barrier, eliminating the need for direct physical connections that would compromise sterility. This maintains both detection accuracy and sterile field integrity.
Solution Approach 2:
The patent replaces mechanical connections between the stylet and console with electromagnetic or wireless communication. This substitution allows the stylet to remain isolated within the sterile field while still transmitting real-time position data to the console, maintaining both sterility and continuous monitoring capability.
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
The system enhances catheter placement accuracy, reduces patient exposure to X-rays, minimizes procedural complexity, and streamlines the placement process by integrating multiple guidance modalities into a single device, ensuring precise and efficient catheter tip positioning within the vasculature.
Implementation Method 1
The tip location sensor senses a magnetic field of a stylet disposed in a lumen of the catheter
Implementation Method 2
The ultrasound probe ultrasonically images a portion of the vasculature prior to introduction of the catheter into the vasculature
Data Source
AI summary
A method of positioning a catheter in a blood vessel. The method includes ultrasonically imaging the blood vessel using an ultrasound probe to generate an ultrasound image, communicating the ultrasound image to a console, and displaying the ultrasound image on the console. The method further includes coupling a stylet to the catheter, the stylet including a stylet control module including a timer circuit, and a coil assembly connected to the stylet control module. The method further includes introducing and advancing the catheter and the coil assembly in the blood vessel, sending an electric pulse signal from the timer circuit to the coil assembly at a pulse signal frequency, emitting an electromagnetic field from the coil assembly, and detecting the electromagnetic field by an external sensor. The method may further include synchronizing the pulse signal frequency, and determining a position of the coil assembly with respect to the external sensor.