System and method for assessing nerve health during a spinal decompression procedure using a calculated nerve function index

Inventors

Nay, David S.Wybo, Christopher

Assignees

Neuralytix LLC

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Publication Number

US-12279881-B1

Patent

Publication Date

2025-04-22

Expiration Date


Abstract

A method for assessing nerve health during a spinal decompression procedure includes: transmitting electrical stimuli to a nerve; detecting muscle responses evoked by the stimuli; determining multiple nerve function parameters based on the responses; calculating a nerve function index based on a weighted combination of the parameters; storing the index in memory; and displaying the index. The nerve function parameters include at least two of: minimum stimulation threshold, maximal stimulation threshold, and magnitude of maximal muscle response.

Core Innovation

The invention assesses nerve health during a decompression procedure by generating, with a processor, a series of electrical stimuli having different current values. The current values are selected to identify a minimum stimulation threshold of a nerve and/or a maximal stimulation threshold of the nerve, and the stimuli are transmitted to an electrode in direct contact with the nerve of a subject. A processor selects the current value for each electrical stimulus at least in part based on an output signal indicative of detected evoked muscle responses.

The invention detects muscle responses evoked by the electrical stimuli using a mechanical sensor in communication with the muscle of the subject. The mechanical sensor generates an output signal representative of the detected muscle responses, which the processor uses to determine a plurality of nerve function parameters. The nerve function parameters include at least two of the minimum stimulation threshold of the nerve, the maximal stimulation threshold of the nerve, and a magnitude of a maximal muscle response of the muscle.

The invention calculates a nerve function index based on a weighted combination of the determined nerve function parameters. The nerve function index is stored in memory and displayed on a display device, including display relative to a nerve function index target range. In additional implementations, the processor analyzes the output signal to determine the nerve function parameters and supports probabilistic measures and database-derived individualized target ranges based on historical patient outcomes and similar pre-operative characteristics.

Claims Coverage

The document includes two independent claims (a method and a system) that share a common inventive core: adaptive selection of electrical stimulus current values guided by a mechanical sensor output, determination of nerve function parameters, and computation and display of a weighted nerve function index. Across the dependent claims, inventive coverage extends to target-range comparison, normalization and weighted-combination specifics, mechanomyography sensor modality, and statistical/probabilistic decision support based on historical outcomes and similar patients, yielding multiple inventive features in each independent claim’s framework.

Adaptive stimulus current selection using mechanical sensor output

Generating a series of electrical stimuli having different current values to identify a minimum stimulation threshold and/or a maximal stimulation threshold, transmitting the series to an electrode, and selecting the current value for each electrical stimulus at least in part based on the received output signal indicative of detected evoked muscle responses.

Mechanical detection of evoked muscle responses for nerve parameter determination

Detecting evoked muscle responses of the subject using a mechanical sensor and receiving an output signal representative of the detected muscle responses, then determining a plurality of nerve function parameters from the detected muscle responses, including at least two of: the minimum stimulation threshold, the maximal stimulation threshold, and a magnitude of a maximal muscle response.

Weighted nerve function index calculation, storage, and display

Calculating a nerve function index based on a weighted combination of the determined nerve function parameters, storing the nerve function index in a memory, and displaying the nerve function index on a display device.

Comparison of nerve function index to target range

Identifying a nerve function index target range and displaying the nerve function index relative to the target range, including implementations where the target range is determined based on historical patient outcomes and similar pre-operative characteristics.

Probabilistic success and risk profiling based on historical outcomes

Determining a probabilistic measure of success for a spinal decompression procedure using a statistical model based on historical patient outcomes and the nerve function index, and displaying the probabilistic measure and related risk information on a display device.

Across the independent method and system claims, the inventive coverage is centered on adaptively selecting electrical stimulus current values using a mechanical sensor output, extracting nerve function parameters from evoked muscle responses, and computing a weighted nerve function index that is stored and displayed. Dependent claim coverage further expands the index handling by adding target-range comparison (including database-derived individualized ranges), specifying normalization/weighted-combination mechanics, using a mechanomyography (MMG) sensor, and generating probabilistic measures derived from historical outcomes.

Stated Advantages

Provides a nerve function index that is displayed for assessing nerve health during a decompression procedure.

Enables comparison of the nerve function index to a target range for context during the procedure.

Determines and displays a probabilistic measure of success based on historical patient outcomes and the nerve function index.

Supports individualized target ranges derived from historical patient outcomes for assessment during the procedure.

Documented Applications

Intraoperative assessment of nerve health during a decompression procedure by stimulating a compressed nerve and measuring evoked muscle responses.

Display of a nerve function index (and relative context versus target ranges) during a decompression procedure for the surgeon.

Probabilistic success measurement for a spinal decompression procedure using historical outcomes and a nerve function index.

Use of historical patient outcomes and similar pre-operative characteristics to define target ranges for an intraoperative nerve function index.

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