Catheter Authorization via Analog Waveform Mixing
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Solution Overview
Problem
Current catheter authorization systems face issues with signal synchronization and unauthorized use due to digitization differences and lack of controlled algorithm enablement, leading to time domain errors and misuse of proprietary algorithms.
Innovation Solution
An analog authorization waveform is mixed with catheter signals, allowing only authorized computing systems to process the signals by removing the waveform, ensuring compatibility and preventing misuse, implemented through a function generator and adaptive filter within the catheter or system interface.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of information
If catheter signals are digitized at the catheter and streamed through USB port, then data can be transmitted to the HEMO/EP system, but signal synchronization is lost and time domain errors occur when referenced with other device signals
Solution Approach 1:
The patent merges the digitization process into a single centralized system at the HEMO/EP device rather than having separate digitization systems at the catheter and the main device. This consolidation ensures all signals are digitized through the same system, maintaining synchronization and eliminating time domain errors between catheter and other device signals.
2Adaptability or versatility
If proprietary digitization algorithms are loaded on the HEMO/EP system, then signal processing can be performed, but the algorithms can be reused or misused by unauthorized devices
Solution Approach 1:
The patent introduces an authorization intermediary mechanism that mediates between the proprietary algorithms and accessing devices. The HEMO/EP system verifies device authorization credentials before enabling access to proprietary algorithms, ensuring that only authorized devices can utilize these algorithms while maintaining system versatility.
Solution Approach 2:
The patent implements preliminary authorization verification before allowing algorithm access. The system checks device credentials and authorization status in advance, preventing unauthorized devices from accessing or reusing proprietary algorithms, thereby protecting intellectual property while maintaining system adaptability.
3Adaptability or versatility
If catheter is connected to incompatible HEMO/EP system, then connection can be made, but signal processing produces errors and breaches regulatory qualification
Solution Approach 1:
The patent performs preliminary compatibility verification when a catheter connects to the HEMO/EP system. The system checks whether the catheter is compatible with the connected HEMO/EP device before enabling signal processing, preventing unauthorized or incompatible connections that would produce errors or breach regulatory qualifications.
Data Source
AI summary
In the present invention, a medical device authorization system is employed to associate software contained on a medical computing system/computer, such as an EP mapping and recording system, that pertains to a specific medical device, e.g., a transducer, connected to the computer such that the software is only utilized by the computer in conjunction with a catheter that is authorized for use with the computer. The authorization system utilizes an analog authorization waveform/signal that is mixed with the analog device/catheter measured signals transmitted to the computer. The authorization waveform distorts the measured signals in a manner that renders the signals able to be displayed by the system but unusable, unless the computer includes a signal filter operably connected to the device/transducer interface that is configured to remove the interfering authorization waveform from the measured signal.