# US 10,869,609 B2 · Device and means of assessing neuromuscular junction status with higher fidelity > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,869,609 B2 - Document ID: US10869609B2 - Status: Granted - Kind: B2 - Application number: 15/529,928 - Filed: 2015-11-25 - Published: 2018-11-22 - Granted: 2020-12-22 - Earliest claimed: 2014-11-26 - Assignees: SafeOp Surgical, Inc. - Applicants: SafeOp Surgical, Inc. - Inventors: Robert Snow; Richard O'Brien - Web page: https://patentgrep.com/patent/US10869609B2 ## CPC - A61B 5/395: Details of stimulation, e.g. nerve stimulation to elicit EMG response - A61B 5/4821: {Determining level or depth of anaesthesia (based on movements A61B5/1106)} - A61B 5/4839: {combined with drug delivery} - A61B 2505/05: Surgical care - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract Devices and methods for stimulation and recording of muscle responses for determining degree of neuromuscular blockade, particularly relevant to elicitation of such responses in those under the influence of anesthesia. A system for estimating the degree of neuromuscular blockade includes at least one stimulating electrode, at least one recording electrode, a pulse generator for providing stimulation to a nerve through the stimulating electrode, and a computing device configured to: apply stimuli to the nerve according to a stimulation protocol, wherein the stimulation protocol provides a plurality of stimulation sequences that vary in frequency of pulses in the stimulation sequence, frequency of the stimulation sequences, number of pulses in the stimulation sequence, or all of the above; measure, by the recording electrode, electrical responses of a muscle; and estimate the degree of neuromuscular blockade based on changes in the electrical responses of the muscle during a stimulation sequence. ## Claims ### Claim 1 A system comprising: at least one stimulating electrode; at least one recording electrode; and a computing device comprising a processor having instructions stored thereon, wherein, when executed by the computing device, cause the computing device to: apply stimuli to a nerve of a patient through the stimulating electrode according to a stimulation protocol, wherein the stimulation protocol provides a plurality of stimulation sequences that vary in frequency of pulses in each stimulation sequence of the plurality of stimulation sequences, a frequency of each stimulation sequence of the plurality of stimulation sequences, a number of pulses in each stimulation sequence of the plurality of stimulation sequences, or all of the above; measure, by the at least one recording electrode, electrical responses of a muscle; estimate, by the computing device, a degree of neuromuscular blockade based on changes in the electrical responses of the muscle during a stimulation sequence of the plurality of stimulation sequences; determine, by the computing device, if the stimulation protocol needs to be adjusted, wherein the computing device determines if the stimulation protocol needs to be adjusted at predetermined intervals, upon electrical response readings above or below a threshold value, in response to other physical parameters of the patient, and/or in concert with a timing procedure; and adjust, by the computing device based on the determination that the stimulation protocol needs to be adjusted, based on the estimated degree of neuromuscular blockade, and during the application of the stimuli according to the stimulation protocol, the stimulation protocol. ### Claim 2 (depends on 1) The system of claim 1, wherein estimating the degree of neuromuscular blockade comprises determining a ratio between the electrical response of the muscle from a first pulse in a stimulation sequence and the electrical response of the muscle from a last pulse in the stimulation sequence. ### Claim 3 (depends on 1) The system of claim 1, wherein when the stimulation protocol provides a plurality of stimulation sequences that vary in the number of pulses, the number of pulses is between four and twenty pulses. ### Claim 4 (depends on 3) The system of claim 3, wherein the number of pulses increases with each subsequent stimulation sequence in the stimulation protocol. ### Claim 5 (depends on 1) The system of claim 1, wherein when the stimulation protocol provides a plurality of stimulation sequences that vary in the frequency of pulses, the frequency of pulses is between 2 Hz and 10 Hz. ### Claim 6 (depends on 5) The system of claim 5, wherein the frequency of pulses increases with each subsequent stimulation sequence in the stimulation protocol. ### Claim 7 (depends on 1) The system of claim 1, wherein the stimulation protocol comprises a first stimulation sequence of four pulses at a first frequency, a second stimulation sequence of four pulses at a second frequency higher than the first frequency, a third stimulation sequence of four pulses at a third frequency higher than the second frequency. ### Claim 8 (depends on 7) The system of claim 7, wherein the stimulation protocol further comprises a fourth stimulation sequence of more than four pulses. ### Claim 9 (depends on 1) The system of claim 1, wherein the processor further comprises instructions that when executed by the computing device, cause the computing device to function automatically, without user input. ### Claim 10 (depends on 9) The system of claim 9, wherein the computing device automatically determines if the stimulation protocol needs to be adjusted and adjusts the stimulation protocol. ### Claim 11 (depends on 1) The system of claim 1, wherein the nerve is a peripheral nerve. ### Claim 12 (depends on 11) The system of claim 11, wherein the peripheral nerve is at least one of the nerves in a group comprising: an ulnar nerve, a median nerve, a peroneal nerve, and a posterior tibial nerve. ### Claim 13 (depends on 1) The system of claim 1, wherein the stimulating electrode is configured to be positioned on a wrist or an ankle of a patient. ### Claim 14 (depends on 1) The system of claim 1, further comprising a display unit for displaying information about a patient. ### Claim 15 (depends on 14) The system of claim 14, wherein the information is information related to the degree of neuromuscular blockade. ### Claim 16 A computerized method for estimating the degree of neuromuscular blockade, comprising: applying stimuli to a nerve through a stimulating electrode according to a stimulation protocol, wherein the stimulation protocol provides a plurality of stimulation sequences comprising a plurality of pulses that vary in frequency of pulses in each stimulation sequence of the plurality of stimulation sequences, frequency of each stimulation sequence of the plurality of stimulation sequences, number of pulses in each stimulation sequence of the plurality of stimulation sequences, or all of the above; measuring, by a recording electrode, electrical responses of a muscle; estimating, by a computing device coupled to the stimulating electrode and the recording electrode, a degree of neuromuscular blockade based on changes in the electrical responses of the muscle during a stimulation sequence of the plurality of stimulation sequences; determining, by the computing device, if the stimulation protocol needs to be adjusted, based on the estimation of the degree of neuromuscular blockade; and adjusting, by the computing device based on the determination that the stimulation protocol needs to be adjusted, based on the estimated degree of neuromuscular blockade, and during the application of the stimuli according to the stimulation protocol, the stimulation protocol. ### Claim 17 (depends on 16) The method of claim 16, wherein estimating the degree of neuromuscular blockade comprises determining a ratio between the electrical response of the muscle from a first pulse in a stimulation sequence and the electrical response of the muscle from a last pulse in the stimulation sequence. ### Claim 18 (depends on 16) The method of claim 16, wherein the nerve is a peripheral nerve. ### Claim 19 (depends on 18) The method of claim 18, wherein the peripheral nerve is at least one of the nerves in a group comprising: an ulnar nerve, a median nerve, a peroneal nerve, and a posterior tibial nerve. ### Claim 20 (depends on 16) The method of claim 16, wherein the stimulating electrode is positioned on a wrist or an ankle of a patient. ### Claim 21 (depends on 16) The method of claim 16, wherein the stimulation protocol comprises a first stimulation sequence of four pulses at a first frequency, a second stimulation sequence of four pulses at a second frequency higher than the first frequency, a third stimulation sequence of four pulses at a third frequency higher than the second frequency. ### Claim 22 (depends on 21) The method of claim 21, wherein the stimulation protocol further comprises a fourth stimulation sequence of more than four pulses. ### Claim 23 (depends on 16) The method of claim 16, wherein information related to the degree of neuromuscular blockade is displayed on a display unit. ### Claim 24 (depends on 16) The method of claim 16, wherein the computing device determines if the stimulation protocol needs to be adjusted at predetermined intervals, upon electrical response readings above or below a threshold value, in response to other physical parameters of the patient, and/or in concert with a timing of a procedure. ### Claim 25 A system for estimating the degree of neuromuscular blockade, the system comprising a computing device comprising a processor having instructions stored thereon, wherein, when executed by the computing device, cause the computing device to provide a first set of electrical stimuli to a nerve according to a stimulation protocol; measure muscle responses to the stimuli; estimate, based on the measured muscle responses, the degree of neuromuscular blockade; determine, based on the estimation, when the stimulation protocol needs to be adjusted; and then automatically adjusts the stimuli by varying the frequency of pulses in a second set of stimuli, a number of pulses in the second set of stimuli, or both. ### Claim 26 A computerized method for estimating the degree of neuromuscular blockade comprising providing a first set of electrical stimuli to a nerve according to a stimulation protocol; measuring muscle responses to the stimuli; estimating, based on the measured muscle responses, the degree of neuromuscular blockade; determining, based on the estimation, when the stimulation protocol needs to be adjusted; and then automatically adjusts the stimuli by varying the frequency of pulses in a second set of stimuli, a number of pulses in the second set of stimuli, or both.