Granted Patent B2

US 12,708,318 · App. 18/352,975 · Granted Aug 18, 2026

Inventors: Richard A. O'Brien (Cockeysville, MD); Gregg Johns (Oceanside, CA); Robert Snow (Phoenix, MD); James E. Gharib (San Diego, CA)

Assignee: Alphatec Spine, Inc.

A61B5/395A61B5/388A61B5/7214A61N1/36017G16H20/30A61B5/7264A61B5/746

Abstract

Claims (60)

1 . A method for determining a stimulation threshold current level to avoid tetany associated with one or more muscles, the method comprising:

causing, by a stimulation system comprising one or more data processors, stimulation, via one or more electrodes, of tissue of a patient as a sequence of pulses delivered at a current level and a frequency, the causing including increasing the current level of each sequential pulse in the sequence of pulses by a first current increment;

determining, by the stimulation system, that a first evocation pulse from the sequence of pulses evokes a first muscular response, the first evocation pulse reaching predetermined criteria, the first evocation pulse having a first evocation current level, the first muscular response comprising a first evoked response that is processed by the stimulation system to classify the first evoked response;

causing, by the stimulation system, stimulation, via the one or more electrodes, of the tissue with a second evocation pulse from the sequence of pulses to evoke a second muscular response, the causing comprising:

maintaining or decreasing the frequency between each pulse in the sequence of pulses; and

maintaining the current level of one or more pulses in the sequence of pulses at the current level of the first evocation pulse or increasing the current level of one or more pulses in the sequence of pulses from the immediately preceding pulse by a second current increment;

determining, by the stimulation system, that the second evocation pulse from the sequence of pulses evokes the second muscular response, the second muscular response comprising a second evoked response that is processed by the stimulation system to compare the first evoked response to the second evoked response; and

storing, by the stimulation system, based at least in part on the determination that the first evocation pulse evokes the first muscular response and the determination that the second evocation pulse evokes the second muscular response, the first evocation current level as the stimulation threshold current level.

2 . The method of claim 1 , further comprising determining, by the stimulation system, that the first evocation pulse and the second evocation pulse are not due to artifact noise present within a first signal representing the first muscular response and artifact noise present within a second signal representing the second muscular response.

3 . The method of claim 1 , wherein the second current increment is equal to the first current increment.

4 . The method of claim 1 , wherein the determining that the first evocation pulse from the sequence of pulses evokes the first muscular response further comprises: storing the first evocation current level of the first evocation pulse.

5 . The method of claim 1 , wherein the determining that the first evocation pulse evokes the first muscular response includes receiving, by the stimulation system, a first signal representing the first muscular response and the determining that the second evocation pulse evokes the second muscular response includes receiving, by the stimulation system, a second signal representing the second muscular response.

6 . The method of claim 5 , further comprising:

comparing, by the stimulation system, the first signal to the second signal;

determining, by the stimulation system, that the first signal can be repeatably obtained-based on the comparison between the first signal and the second signal; and

displaying, by the stimulation system, the first evocation current level of the first evocation pulse.

7 . The method of claim 6 , wherein the first signal and the second signal are compared as a group of signals that includes a third signal representing a third muscular response evoked in response to a third evocation pulse.

8 . The method of claim 5 , further comprising:

comparing, by the stimulation system, the first signal to the second signal;

determining, by the stimulation system, that the first signal is not repeatably obtained based on the comparison between the first signal and the second signal;

causing, by the stimulation system, stimulation of the tissue with a third evocation pulse from the sequence of pulses to evoke a third muscular response, the causing comprising:

increasing or maintaining, by the stimulation system, the frequency between each pulse in the sequence of pulses; and

increasing, by the stimulation system, the current level of each pulse in the sequence of pulses from the immediately preceding pulse or maintaining the current level of each pulse in the sequence of pulses from the immediately preceding pulse.

9 . The method of claim 1 , wherein the processing of the first evoked response comprises preprocessing the first evoked response using one or more filtering techniques or mathematical transforms.

10 . The method of claim 1 , wherein the processing of the second evoked response comprises preprocessing the first evoked response using one or more filtering techniques or mathematical transforms.

11 . A method for determining a stimulation threshold current level in a group of channels of a neuromonitoring device, wherein each channel of the group of channels is associated with one or more muscles, the method comprising:

causing, by a stimulation system comprising one or more data processors, stimulation, via one or more electrodes, of tissue within a predetermined range of current levels as a sequence of pulses delivered at a frequency by delivering stimulation signals, the sequence of pulses including:

a first pulse delivered at a first current level within the predetermined range of current levels; and

a second pulse delivered at a second current level within the predetermined range of current levels, the first pulse being delivered immediately preceding the second pulse, and the second current level being higher than the first current level;

determining that the second pulse evokes a first muscular response, the first muscular response comprising a first evoked response that is processed by the stimulation system to classify the first evoked response;

causing, by the stimulation system, stimulation, via the one or more electrodes, the tissue with a third pulse from the sequence of pulses to evoke a second muscular response, the third pulse being delivered at a third current level that is equal to or higher than the second current level;

determining that the third pulse evokes the second muscular response; and

storing, by the stimulation system, based at least in part on the determination that the second pulse evokes the first muscular response and the determination that the third pulse evokes the second muscular response, the second current level as the stimulation threshold current level.

12 . The method of claim 11 , further comprising determining, by the stimulation system, that the first pulse and the second pulse are not due to artifact noise present within a first signal representing the first muscular response and artifact noise present within a second signal representing the second muscular response.

13 . The method of claim 11 , wherein the stimulating further comprises:

decreasing or maintaining, by the stimulation system, the frequency between each pulse in the sequence of pulses; and

increasing, by the stimulation system, the current level of the third pulse by an amount that is greater than a difference between the first current level and the second current level.

14 . The method of claim 11 , wherein the determining that the second pulse evokes the first muscular response includes receiving, by the stimulation system, a first signal representing the first muscular response and the determining that the third pulse evokes the second muscular response includes receiving by the stimulation system, a second signal representing the second muscular response.

15 . The method of claim 14 , further comprising:

comparing, by the stimulation system, the first signal with the second signal;

determining, by the stimulation system, that the first signal can be repeatably obtained-based on the comparison between the first signal and the second signal; and

displaying, by the stimulation system, the second current level of the second pulse.

16 . The method of claim 15 , wherein the first signal and the second signal are compared as a group of signals that includes a third signal representing a third muscular response evoked in response to a third evocation pulse.

17 . The method of claim 15 , further comprising:

comparing, by the stimulation system, the first signal with the second signal;

determining, by the stimulation system, that the first signal is not repeatably obtained based on the comparison between the first signal and the second signal;

causing, by the stimulation system, stimulation of the tissue with a fourth pulse from the sequence of pulses to evoke a third muscular response, the causing comprising:

increasing or maintaining, by the stimulation system, the frequency between each pulse in the sequence of pulses; and

increasing, by the stimulation system, the current level of each pulse in the sequence of pulses from the immediately preceding pulse or maintaining the current level of each pulse in the sequence of pulses from the immediately preceding pulse.

18 . A stimulation system for detecting and identifying a stimulation threshold to avoid tetany of a patient's muscles, wherein the system comprises:

at least one processor; and

at least one memory storing instructions which, when executed by the at least one processor, result in operations comprising:

causing, by the stimulation system, stimulation, via one or more electrodes, of the patient's tissue with a sequence of pulses delivered at a current level and a frequency, the causing including increasing the current level of each sequential pulse in the sequence of pulses;

determining, by the stimulation system, that a first evocation pulse from the sequence of pulses evokes a first muscular response, the first evocation pulse having a first evocation current level;

continuing to cause, by the stimulation system, stimulation of the patient's tissue with a second evocation pulse from the sequence of pulses to evoke a second muscular response, the causing comprising:

maintaining or decreasing the frequency between each pulse in the sequence of pulses; and

maintaining or increasing the current level of each pulse in the sequence of pulses from the immediately preceding pulse by a second current increment;

determining, by the stimulation system, that the second evocation pulse from the sequence of pulses evokes the second muscular response; and

storing, by the stimulation system, based at least in part on the determination that the first evocation pulse evokes the first muscular response and the determination that the second evocation pulse evokes the second muscular response, the first evocation current level as the stimulation threshold current level.

19 . The system of claim 18 , wherein the operations further comprise determining, by the stimulation system, that the first evocation pulse and the second evocation pulse are not due to artifact noise present within a first signal representing the first muscular response and artifact noise present within a second signal representing the second muscular response.

Assignments (8)

Continuity (4)

References Cited (307)