Multi-Channel Neurophysiological Stimulation Module
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Solution Overview
Problem
Prior art nerve integrity monitoring systems have limitations such as a limited number of low current outputs or channels, inability to simultaneously stimulate multiple nerves or nerve branches, and lack of integration with multi-modality monitoring systems, leading to increased surgical procedure duration, complexity, and inefficiency in neural stimulation and monitoring.
Innovation Solution
A multi-modality intraoperative neurophysiological monitoring (IONM) system with a stimulation module that includes multiple output connectors and probe ports, allowing for user-defined stimulation protocols with adjustable parameters, enabling simultaneous stimulation of multiple neural regions with minimal manual intervention.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a limited number of low current outputs or channels are used, then the device complexity is reduced, but the ability to simultaneously stimulate multiple nerves or multiple branches of single nerves is limited
Solution Approach 1:
The stimulation module is divided into multiple independent output channels (first plurality of output connectors), each capable of delivering low current stimulation to different neural regions. This segmentation allows simultaneous stimulation of multiple nerves without requiring a single complex high-capacity output, resolving the contradiction between versatility and device complexity.
Solution Approach 2:
The stimulation module is designed with multiple output connectors that can be configured for different stimulation modalities (cortical stimulation, direct nerve stimulation, compound muscle action potential stimulation). This multi-functionality enables a single device to handle diverse surgical scenarios without requiring separate specialized equipment, thereby improving adaptability while maintaining manageable complexity.
2Productivity
If frequent manual intervention is used to change the location of the delivered stimulus, then the device complexity is reduced, but the duration of the surgical procedure is increased
Solution Approach 1:
Multiple output connectors are pre-configured and positioned to correspond with different anatomical locations and neural structures. The system allows pre-planned stimulation sequences where different output connectors can be activated without requiring physical relocation of electrodes or probes during the procedure, thereby reducing manual intervention and surgical time.
Solution Approach 2:
The system enables dynamic switching between different output connectors and stimulation modalities through electronic control rather than physical reconfiguration. This dynamic capability allows the stimulation location and parameters to be changed during the procedure without manual intervention, improving productivity while maintaining ease of operation.
3Adaptability or versatility
If prior art stimulators are used with limited integration, then the device complexity is reduced, but the ability to integrate multiple neural stimulation and monitoring modalities is limited
Solution Approach 1:
The stimulation module is integrated with multi-modality monitoring systems, combining neural stimulation capabilities with electroencephalography, electromyography, and other monitoring functions. This merging allows simultaneous performance of multiple modalities within a unified system, improving adaptability while managing complexity through integrated design rather than separate components.
Solution Approach 2:
The system is designed to support multiple stimulation modalities (cortical, direct nerve, compound muscle action potential) and multiple monitoring modalities within a single integrated platform. This universality enables diverse surgical applications without requiring multiple separate devices, thereby improving adaptability while the integrated architecture manages complexity through standardized interfaces and unified control.
4Power
If insufficient amplitude electrical stimulation is applied, then the device complexity is reduced, but the ability to elicit excitation activity of the muscles is compromised
Solution Approach 1:
The system provides adjustable stimulation parameters including amplitude, pulse width, frequency, and duty cycle for each output connector. This parameter adjustability allows optimization of stimulation amplitude for different neural structures and surgical scenarios, achieving sufficient muscle excitation activity while maintaining manageable device complexity through electronic parameter control rather than hardware complexity.
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 allows for efficient and streamlined neural structure assessment during surgical procedures, reducing procedural duration and complexity by enabling multiple stimulation modalities with reduced manual intervention and integrating various monitoring modalities.
Implementation Method 1
applying electrical stimulation at or near an area where the target neural structures are believed to be located. Application of the electrical stimulation is transmitted through the nervous system structures to excite or depress the associated response(s) or function(s)
Implementation Method 2
an electrical impulse is generated in the muscle(s), as a result of the excitation, that can be sensed using recording electrodes
Data Source
AI summary
An intraoperative neurophysiological monitoring (IONM) system for identifying and assessing neural structures comprises at least one probe, at least one reference electrode, at least one strip or grid electrode, at least one sensing electrode, and a stimulation module. Threshold responses determined by stimulation during a surgical procedure are used to identify and assess functionality of neural structures. The identified neural structures are avoided and preserved while diseased or damaged tissue is resected during said surgical procedure.