External Detector for Implantable Neurostimulation Leads
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Solution Overview
Problem
Current neurostimulation systems lack a reliable and practical method to monitor implanted leads, detect lead migration, identify electrode malfunctions, and log data on stimulation outputs, which complicates patient care and diagnosis, especially in emergency situations and requires exposure to radiation for lead localization.
Innovation Solution
An external detector system with a handheld probe having instrumentation amplifiers and closely spaced surface electrodes that measure and amplify the electrical field of implanted electrodes, allowing for non-invasive localization and diagnosis of lead position and functionality, and providing graphical representations of stimulation outputs to identify faulty electrodes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fluoroscopy systems are used to locate implanted leads, then lead position can be identified, but patient exposure to radiation occurs
Solution Approach 1:
The patent replaces fluoroscopy (radiation-based imaging) with an electrical field detection system. The external detector uses surface electrodes to measure electrical potentials generated by the implanted neurostimulation device, substituting a non-ionizing electrical measurement method for the harmful radiation-based method while maintaining lead localization capability
Solution Approach 2:
The patent introduces electrical potential measurements as an intermediary to indirectly locate the implanted lead. Instead of directly imaging the lead with radiation, the system measures electrical potentials on the skin surface that are generated by the implanted device, using these potentials as a mediator to infer lead position without exposing the patient to radiation
2Reliability
If no monitoring system is used for implanted leads, then device complexity is reduced, but lead migration and electrode malfunction cannot be detected
Solution Approach 1:
The patent utilizes the implanted neurostimulation device's own electrical output to monitor its own position and functionality. The external detector measures electrical potentials generated by the device during normal operation, allowing the system to self-monitor without requiring separate active transmission components in the implant
Solution Approach 2:
The patent replaces complex active monitoring systems with passive electrical field measurement. Instead of requiring the implant to actively transmit position data or require complex imaging equipment, the system uses simple surface electrodes to detect electrical potentials, significantly reducing overall system complexity while maintaining monitoring capability
3Measurement precision
If multiple separate systems are used for lead localization and stimulation monitoring, then measurement precision is improved, but device complexity increases
Solution Approach 1:
The patent creates a multi-functional external detector that performs multiple tasks: locating the implanted lead, identifying individual electrodes, characterizing electrode performance, and logging stimulation data. This single device replaces what would otherwise require multiple separate systems, reducing overall complexity while maintaining comprehensive monitoring precision
Solution Approach 2:
The patent combines lead localization, electrode identification, and stimulation monitoring functions into a single integrated external detector system. By merging these functions that could be performed by separate devices into one unit, the system reduces complexity while maintaining the measurement precision of each individual function
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 non-invasive detection and diagnosis of implanted neurostimulation leads and devices, reducing radiation exposure and facilitating efficient reprogramming and data logging, while allowing for real-time analysis and improved patient care.
Implementation Method 1
The probe includes two or more surface electrodes that measure the electrical field of implanted electrodes
Implementation Method 2
The amplifier includes a first input coupled to the first surface electrode, a second input coupled to the second surface electrode, and an output that produces an amplified signal
Data Source
AI summary
Embodiments herein include an external system and method to detect an implanted lead coupled to an implanted neurostimulation device (INSD). The system and method comprise a handheld probe having electrodes configured to be positioned external to a surface of a patient and proximate to a region of the patient having the implanted lead for an implanted INSD. The electrodes are configured to measure a stimulation output from the implanted lead of the INSD. The system and method include a controller coupled to the electrodes to receive measured signals from the electrodes. The measured signals represent the stimulation output of the INSD. The controller processes the measured signals to obtain lead information. The system includes a user interface to present the lead information to a user. The lead information is indicative of at least one of an operation of the lead and a position of the lead.