ECG-Guided Vascular Access Device for Catheter Tip Verification
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Solution Overview
Problem
Current methods for verifying the tip position of central venous access devices during procedures are either costly, risky, or time-consuming, with post-procedural imaging methods being common despite the advantages of intra-procedural electrocardiography (ECG) for accuracy and safety.
Innovation Solution
Development of devices and methods allowing for safe, effective, and user-friendly electrical connections between central venous catheters and ECG monitors, including shielded wires, valved systems for maintaining saline column integrity, and selective electrical connections to guide catheter placement using ECG guidance during and after procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If post-procedural imaging methods (chest x-ray, CT, MRI) are used to verify catheter tip position, then measurement accuracy is achieved, but loss of time and productivity are increased due to delays in confirming proper placement
Solution Approach 1:
The patent replaces mechanical/radiological imaging systems (x-ray, CT, MRI) with an electrical field-based ECG monitoring system. The ECG method detects catheter tip position by measuring electrical potential changes in the heart when the catheter tip contacts specific cardiac structures, eliminating the need for time-consuming post-procedural imaging while maintaining verification accuracy.
Solution Approach 2:
The patent introduces an electrolyte solution as an intermediary medium that enables electrical conduction between the catheter tip and the ECG monitoring system. This electrolyte bridge allows the ECG system to detect catheter position through electrical signals without requiring direct electrical contact or invasive measurements, resolving the contradiction by providing a non-invasive, rapid verification method.
2Productivity
If intra-procedural ECG method is used to verify catheter tip position, then productivity and time efficiency are improved, but device complexity increases due to need for electrical connections and sterile barriers
Solution Approach 1:
The patent makes the catheter hub serve multiple functions: it acts as both the fluid administration interface and the electrical connection point for ECG monitoring. By integrating the electrical contact capability into the existing catheter hub structure, the system avoids adding separate complex connection devices while enabling intra-procedural verification.
Solution Approach 2:
The patent uses a sterile barrier with integrated electrical properties as an intermediary that allows electrical signal transmission while maintaining sterility. This specialized barrier simplifies the overall system by combining sterile isolation and electrical conduction functions in a single component, reducing the number of separate parts needed for safe intra-procedural monitoring.
3Ease of operation
If standard catheters without electrical connection capability are used, then ease of operation is maintained, but measurement precision for ECG-guided placement cannot be achieved
Solution Approach 1:
The patent merges the electrical conduction function with the existing catheter structure by incorporating conductive materials or electrical contacts into the catheter hub and lumen. This integration allows standard catheter insertion procedures to be performed while simultaneously enabling ECG-guided position verification, maintaining ease of operation while adding measurement precision.
Solution Approach 2:
The patent transforms the catheter into a multi-functional device that simultaneously performs fluid administration and electrical signal transmission for ECG monitoring. This universal design allows the same catheter to be used for both therapeutic purposes and diagnostic verification without requiring separate devices, maintaining operational simplicity while enabling precise positioning.
4Measurement precision
If electrical connections are made during sterile procedures, then measurement precision is improved, but object-generated harmful factors increase due to risk of contamination
Solution Approach 1:
The patent introduces a sterile barrier as an intermediary component that physically separates the non-sterile electrical equipment from the sterile catheter system while allowing electrical signal transmission. This barrier eliminates contamination risk by maintaining the sterile field integrity, enabling ECG-guided verification without compromising sterility.
Solution Approach 2:
The patent employs disposable sterile connectors or barriers that are discarded after single use, eliminating the risk of cross-contamination from repeated use of electrical connection components. This approach ensures that each procedure uses a fresh sterile interface, preventing contamination while enabling accurate ECG measurements.
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, cost-effective, and safer verification of catheter tip placement using ECG guidance, reducing the need for post-procedural imaging and allowing for continuous flush and electrical conduction, thus improving procedural efficiency and patient safety.
Implementation Method 1
making an electrical connection between an electrolyte and an electric wire
Data Source
AI summary
A new device and a method are provided which allow for making an electrical connection between an electrolyte and an electric wire. A new connector is provided which allows to be used by a single sterile operator. A new valved device is provided which allows for maintaining the integrity and the pressure of a saline column in the central venous line. A new device is provided which allows for automatically maintaining a continuous flush of a saline syringe in order to allow for keeping the valves of central venous lines open and capable of electric conduction. A new syringe is provided which allows for simultaneous electrical connection between the fluid in the syringe and an electrical wire. Several new methods are provided for making an electrical connection to a central venous line during and after the catheter placement procedure.