Granted Patent B1

US 12,279,880 · App. 18/799,984 · Granted Apr 22, 2025

Inventors: David S. Nay (Novi, MI); Christopher Wybo (Brighton, MI)

Assignee: Neuralytix, LLC

A61B5/4052A61B5/4848A61B5/6804A61B5/7264A61B5/7275A61B5/7405A61B5/743A61B5/746G16H10/60G16H50/30G16H50/70A61B2560/0462A61B2562/0219

Abstract

Claims (51)

1. A method for intraoperative neural monitoring during a spinal decompression procedure, the method performed by a system comprising a processor, the method comprising:

generating, by the processor, an electrical stimulus having a controlled electrical current;

transmitting the electrical stimulus from the processor to an electrode in direct contact with a nerve of a subject;

receiving, by the processor, 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;

determining, by the processor, a nerve function parameter comprising at least one of: a minimum electrical current of the electrical stimulus that is required to evoke a mechanical response of the muscle (a stimulation threshold) or a minimum electrical current of the electrical stimulus that is required to evoke a maximal response of the muscle (a saturation threshold);

displaying, via a display in communication with the processor, the determined nerve function parameter relative to an identified probabilistic range of current values that is predictive of the nerve function parameter when the nerve is fully decompressed; and

wherein the probabilistic range of current values is based, at least in part, on one or more subject-specific attributes, subject comorbidities, and/or an assessment of subject pre-operative neurological functioning.

2. The method of claim 1 , wherein the nerve function parameter is the minimum electrical current of the electrical stimulus that is required to evoke a mechanical response of the muscle; and

wherein the probabilistic range of current values is a range of current values that is less than the determined nerve function parameter and is predictive of the minimum electrical current of the electrical stimulus that will be required to evoke a mechanical response of the muscle when the nerve is a fully decompressed nerve.

3. The method of claim 1 , wherein the determined nerve function parameter is a first nerve function parameter and wherein the first nerve function parameter is determined prior to a portion of the spinal decompression procedure;

the method further comprising:

determining, by the processor after the portion of the spinal decompression procedure, a second nerve function parameter; and

displaying, via the display, the second nerve function parameter relative to both the probabilistic range of current values and the first nerve function parameter.

4. The method of claim 3 , further comprising, generating an audible or visual alert, by the processor, if the second nerve function parameter is within the probabilistic range of current values.

5. The method of claim 1 , wherein the nerve function parameter includes a stimulation threshold and wherein the probabilistic range of current values is a range of electrical current values that includes at least the range of about 2 mA to about 3 mA.

6. The method of claim 1 , further comprising:

accessing, by the system, a database of historical data comprising nerve function measurements obtained during previous spinal decompression procedures, subject-specific attributes from the previous spinal decompression procedures (“historical-attributes”), and associated subject outcomes from those previous spinal decompression procedures (“historical-outcomes”);

identifying, by the system, a subset of patients in the database with historical-attributes similar to the subject undergoing the spinal decompression;

defining, by the system, the probabilistic range of current values as a range of electrical current values for the nerve function parameter that are associated with successful outcomes in the subset of patients.

7. A method for intraoperative neural monitoring during a spinal decompression procedure, the method performed by a system comprising a processor, the method comprising:

generating, by the processor, an electrical stimulus having a controlled electrical current;

transmitting the electrical stimulus from the processor to an electrode in direct contact with a nerve of a subject;

receiving, by the processor, 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;

determining, by the processor, a nerve function parameter comprising at least one of: a minimum electrical current of the electrical stimulus that is required to evoke a mechanical response of the muscle (a stimulation threshold); or a minimum electrical current of the electrical stimulus that is required to evoke a maximal response of the muscle (a saturation threshold);

displaying, via a display in communication with the processor, the determined nerve function parameter relative to an identified target current range or statistical profile that is 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, via the display, an indication of the determined statistical risk of complications.

8. A system for assessing the completeness of spinal nerve decompression during surgery, the system comprising:

a stimulator configured to deliver electrical stimuli to a compressed nerve;

a sensor configured to detect muscle responses evoked by the electrical stimuli;

a display configured to provide real-time feedback to a surgeon; and

a processor configured to:

control the stimulator to deliver the electrical stimuli to the compressed nerve;

measure a nerve function parameter at a plurality of time points during a spinal decompression procedure based on the muscle responses detected by the sensor;

assess the completeness of the spinal decompression by comparing the measured nerve function parameter to a probabilistic range of nerve function parameter values that are indicative of a fully decompressed nerve; and

provide real-time feedback to the surgeon via the display, the feedback comprising an indication of the difference between the measured nerve function parameter and the range of nerve function parameter values; and

wherein the probabilistic range of nerve function parameter values is based, at least in part, on one or more subject-specific attributes, subject comorbidities, and/or an assessment of subject pre-operative neurological functioning.

9. The system of claim 8 , wherein the processor is configured to measure the nerve function parameter by determining a minimum electrical current of the electrical stimulus that is required to evoke a mechanical response of the muscle;

wherein the probabilistic range of nerve function parameter values is an identified target current range; and

wherein the feedback provided by the processor comprises a display of the determined minimum electrical current relative to the identified target current range.

10. The system of claim 9 , wherein the target current range is a range of electrical current values that includes at least the range of about 2 mA to about 3 mA.

11. The system of claim 8 , wherein the processor is further configured to:

access a database of historical data comprising nerve function parameters obtained during previous spinal decompression procedures, patient attributes from the previous spinal decompression procedures, and associated subject outcomes from the previous spinal decompression procedures;

identify a subset of patients in the database with similar attributes to the subject undergoing the spinal decompression;

define the target current range as a range of electrical currents associated with successful outcomes in the subset of patients.

12. The system of claim 8 , wherein the sensor is a mechanical sensor comprising an accelerometer configured to detect a mechanical muscle response evoked by the electrical stimuli.

13. The system of claim 8 , wherein the nerve function parameter comprises a nerve function index; and

wherein the nerve function index is a weighted average of at least two of:

the minimum electrical current of the electrical stimuli that is required to evoke a mechanical response of the muscle (stimulation threshold);

the minimum electrical current of the electrical stimuli that is required to evoke a maximal response of the muscle (saturation threshold); and

the magnitude of the maximal response of the muscle, measured via the sensor.

Assignments (1)

References Cited (61)

Cited By (1)

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