Implanted Neurostimulation Electrode Positioning With Bidirectional Monitoring
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Solution Overview
Problem
Existing neuromodulation devices, such as SCS paddles, often fail due to mis-positioning during implantation, leading to high surgical revision rates, as current intraoperative techniques are unreliable and require direct patient interaction under anesthesia, which can be misleading.
Innovation Solution
A system and method for connecting a surgically implanted neurostimulation device, like an SCS paddle lead, to a neurophysiological monitoring device using a wire harness with DIN pin connectors, enabling bidirectional stimulation and recording signals for precise electrode positioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional intraoperative techniques are used for electrode positioning, then direct patient interaction can be performed, but the positioning reliability deteriorates due to misleading sensations under anesthesia
Solution Approach 1:
The patent introduces neurophysiological monitoring devices as intermediary tools to objectively assess electrode positioning. These devices serve as mediators between the surgical team and patient physiology, providing reliable feedback without requiring direct patient interaction or subjective sensation reporting under anesthesia.
Solution Approach 2:
The patent replaces subjective mechanical interaction (direct patient sensation reporting) with objective neurophysiological monitoring systems that measure electrical signals from the nervous system. This substitution eliminates the unreliability of patient sensation under anesthesia while maintaining positioning accuracy.
2Measurement precision
If multiple mapping techniques are performed sequentially, then comprehensive electrode positioning can be achieved, but surgical time increases
Solution Approach 1:
The patent merges multiple neurophysiological monitoring devices and mapping techniques into a single integrated system that can operate concurrently. This combination allows simultaneous performance of multiple assessment techniques (e.g., EMG, sensory evoked potentials, motor evoked potentials) without sequential time penalties, thereby reducing total surgical time while maintaining comprehensive positioning precision.
Solution Approach 2:
The patent employs a universal neurophysiological monitoring platform capable of performing multiple mapping techniques through different sensor configurations and signal processing modes. This multi-functional system eliminates the need for separate dedicated devices for each technique, streamlining the surgical workflow and reducing time losses.
3Productivity
If manual parameter recording is used, then flexibility in recording can be maintained, but accuracy and efficiency deteriorate
Solution Approach 1:
The patent implements self-service automation where the neurophysiological monitoring devices automatically record, store, and analyze stimulation parameters without requiring manual intervention. The system self-manages data collection, automatically adjusts recording settings based on predefined protocols, and maintains accurate parameter logs, thereby eliminating manual recording errors and time-consuming processes.
Solution Approach 2:
The patent incorporates automated feedback mechanisms where the system continuously monitors recorded parameters and provides real-time verification of accuracy. The automated system cross-checks recorded values against expected ranges and protocols, ensuring high accuracy while reducing the operational burden on the surgical team.
Data Source
AI summary
A system is provided for connecting a surgically implantable neurostimulation device to an neurophysiological monitoring device. The system includes an apparatus connecting the neurophysiological monitoring device to the implanted neurostimulation device. The connecting apparatus includes a port couplable to the neurostimulation device and a plurality of electrode pin connectors extending from the port that are connectable to the neurophysiologic monitoring device. Using the connecting apparatus, signals from the neurophysiologic monitoring device can be transmitted for stimulation and responses can be transmitted to the neurophysiologic monitoring device to enable accurate positioning of electrodes of the neurostimulation device.