System and method for assessing nerve health during a spinal decompression procedure
Inventors
Nay, David S. • Wybo, Christopher
Assignees
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Abstract
A method for intraoperative neural monitoring during a spinal decompression procedure, performed by a system comprising a processor, includes: generating an electrical stimulus with a controlled electrical current; transmitting the stimulus to an electrode contacting a nerve of a subject; receiving a mechanomyography (MMG) output signal from a mechanical sensor contacting a muscle innervated by the nerve; determining a nerve function parameter; and displaying the determined nerve function parameter relative to an identified target current range or statistical profile.
Core Innovation
The invention relates to intraoperative neural monitoring during a spinal decompression procedure. A processor generates an electrical stimulus having a controlled electrical current and transmits the stimulus to an electrode in direct contact with a nerve of a subject. The processor receives a mechanomyography (MMG) output signal from a mechanical sensor in contact with a muscle of the subject, wherein the muscle is innervated by the nerve.
The processor determines a nerve function parameter comprising at least one of a stimulation threshold and a saturation threshold. The stimulation threshold comprises a minimum electrical current required to evoke a mechanical response of the muscle, and the saturation threshold comprises a minimum electrical current required to evoke a maximal response of the muscle. The processor displays the determined nerve function parameter relative to an identified probabilistic range of current values predictive of the nerve function parameter when the nerve is fully decompressed.
The probabilistic range of current values is based, at least in part, on subject-specific attributes, subject comorbidities, and/or an assessment of subject pre-operative neurological functioning. In some aspects, the probabilistic range or target current range or statistical profile is predictive when the nerve is fully decompressed, and a statistical risk of complications is determined from the determined nerve function parameter together with one or more subject-specific attributes, subject comorbidities, and/or subject pre-operative neurological functioning. A system may measure the nerve function parameter at a plurality of time points and assess completeness by comparing the measured parameter to the probabilistic range indicative of a fully decompressed nerve, providing real-time feedback via a display to a surgeon.
Claims Coverage
The document includes three independent claims: a method claim, a method claim, and a system claim. The claims center on processor-controlled electrical stimulation of a compressed nerve, MMG-based detection of muscle responses, determination of stimulation and/or saturation thresholds as nerve function parameters, and comparison to probabilistic/target ranges or statistical profiles predictive of fully decompressed nerve function; one claim further determines a statistical risk of complications and another provides real-time completeness assessment via multi-time-point comparison.
Processor-controlled electrical stimulus with direct nerve electrode and MMG muscle sensor
Generating an electrical stimulus having a controlled electrical current, transmitting the electrical stimulus to an electrode in direct contact with a nerve of a subject, and receiving a mechanomyography (MMG) output signal from a mechanical sensor in contact with a muscle innervated by the nerve.
Stimulation threshold and saturation threshold nerve function parameter from MMG responses
Determining a nerve function parameter comprising at least one of a stimulation threshold or a saturation threshold from muscle responses.
Probabilistic range predictive of full decompression based on subject-specific attributes
Displaying the determined nerve function parameter relative to an identified probabilistic range of current values predictive of the nerve function parameter when the nerve is fully decompressed, wherein the probabilistic range is based, at least in part, on subject-specific attributes, subject comorbidities, and/or an assessment of subject pre-operative neurological functioning.
Target current range or statistical profile predictive of full decompression and complication risk display
Displaying the determined nerve function parameter relative to an identified target current range or statistical profile predictive of the nerve function parameter when the nerve is fully decompressed; determining a statistical risk of complications from the determined nerve function parameter and one or more subject-specific attributes, subject comorbidities, and/or subject pre-operative neurological functioning; and displaying an indication of the determined statistical risk.
System for real-time completeness assessment via comparison across multiple time points
Controlling a stimulator to deliver electrical stimuli to a compressed nerve, measuring a nerve function parameter at a plurality of time points during a spinal decompression procedure based on muscle responses detected by a sensor, assessing completeness by comparing the measured nerve function parameter to a probabilistic range indicative of a fully decompressed nerve, and providing real-time feedback to a surgeon via a display including an indication of the difference between the measured nerve function parameter and the probabilistic range.
Across the independent claims, the common inventive concept is to use processor-controlled electrical stimulation and MMG mechanical sensing to determine nerve function parameters and present these parameters relative to probabilistic or target ranges or statistical profiles predictive of full decompression, with optional determination and display of statistical risk of complications and real-time completeness assessment via multi-time-point comparison.
Stated Advantages
Displays the determined nerve function parameter relative to a probabilistic range of current values predictive of the nerve function parameter when the nerve is fully decompressed.
Provides real-time feedback to a surgeon including an indication of the difference between the measured nerve function parameter and the probabilistic range of nerve function parameter values indicative of full decompression.
Displays an indication of a determined statistical risk of complications.
Documented Applications
No documented applications found
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