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EP-4304705-B1 - STIMULATION SYSTEM

EP4304705B1EP 4304705 B1EP4304705 B1EP 4304705B1EP-4304705-B1

Inventors

  • CLEVELAND, Daniel, Milton
  • JOHNS, Gregg
  • SNOW, Robert, Gerard
  • O'BRIEN, Richard, Arthur

Dates

Publication Date
20260506
Application Date
20220310

Claims (15)

  1. A stimulation system (100) for detecting and identifying a patient physiological response, the stimulation system comprising: at least one processor (510); and at least one memory (520) storing instructions which, when executed by the at least one data processor, result in operations comprising: stimulating, via a stimulating electrode (120) coupled to a patient (10), one or more nerves of the patient; recording, via a recording electrode (110) coupled to the patient, a plurality of resultant electrical waveforms; determining, based on the plurality of resultant electrical waveforms, whether at least a subset of the plurality of resultant electrical waveforms includes a patient physiological response, the determining comprising: comparing the subset of resultant electrical waveforms of the plurality of resultant electrical waveforms to a model waveform (116) derived from a database of a plurality of template waveforms (112, 114); and determining, based on the comparison, a comparison feature, the comparison feature indicating whether the patient physiological response exists in the subset of resultant electrical waveforms; and displaying, via a display (54), an indication when the patient physiological response exists in the subset of resultant electrical waveforms.
  2. The system (100) of claim 1, wherein the model waveform (116) comprises a predicted physiological response and an ensemble average of a plurality of artifact signals.
  3. The system (100) of claim 2, wherein the comparison feature further indicates whether an artifact signal exists in the subset of resultant electrical waveforms, the artifact signal generated by noise.
  4. The system (100) of claim 3, wherein the operations further comprise: displaying, via the display (54), an indication that the artifact signal exists in the subset of resultant electrical waveforms.
  5. The system (100) of any one of claims 1 to 4, wherein the determining whether at least the subset of the plurality of resultant electrical waveforms includes the patient physiological response further comprises: labeling, based on the comparison feature, the subset of the plurality of resultant electrical waveforms with a positive label or a negative label, the positive label indicating that the patient physiological response exists, and the negative label indicating that the patient physiological response does not exist.
  6. The system (100) of any one of claims 1 to 5, wherein the determination of whether the plurality of resultant electrical waveforms includes the patient physiological response further comprises: determining that the patient physiological response exists when the comparison feature of the subset of electrical waveforms is within a threshold range of a threshold value of the comparison feature.
  7. The system (100) of claim 6, wherein the comparison feature comprises one or more of a means squared error between the subset of resultant electrical waveforms and the model waveform (116), a correlation between the subset of resultant electrical waveforms and the model waveform (116), a physiological coefficient amplitude, a power of fundamental harmonic noise, a THP of higher harmonic noise, a ratio of a physiological coefficient of the subset of resultant electrical waveforms to a power of the harmonic noise, and a ratio of variance of the patient physiological response of the subset of resultant electrical waveforms to the predicted physiological response of the model.
  8. The system of any one of claims 1 to 7, wherein the determination of whether the plurality of resultant electrical waveforms includes the patient physiological response further comprises: determining that the patient physiological response exists when a polarity of each electrical waveform of the subset of resultant electrical waveforms is the same.
  9. The system of any one of claims 1 to 8, wherein the comparison feature represents a comparison of a morphology of the subset of resultant electrical waveforms to a morphology of the model waveform (116).
  10. The system of claim 5, wherein the comparison feature comprises a plurality of comparison features, and wherein the labeling is further based on a mathematical representation of the plurality of comparison features.
  11. The system of claim 5, wherein the labeling comprises comparing the comparison feature to a plurality of previously generated comparison features.
  12. The system of any of claims 1 to 11, wherein the subset of the plurality of resultant electrical waveforms are time-locked.
  13. The system of any one of claims 1 to 12, wherein the stimulating comprises transmitting a plurality of electrical stimuli; and wherein the stimulating electrode is in communication with an evoked potential detection device (101) configured to monitor the one or more peripheral nerves of the patient.
  14. The system (100) of claim 13, wherein the plurality of resultant electrical waveforms is received by the evoked potential detection device (101), the resultant electrical waveforms generated by the patient in response to the electrical stimuli.
  15. The system (100) of any one of claims 1 to 14, wherein the template waveforms (112, 114) comprise at least one physiological candidate (112) and at least one noise candidate (114).

Description

CROSS-REFERENCE TO RELATED APPLICATIONS The present application claims priority to U.S. Provisional App. No. 63/160,605, filed March 12, 2021, and entitled "Stimulation System". TECHNICAL FIELD The subject matter described herein relates generally to patient monitoring and clinical neurophysiology, and more specifically to a stimulation system for detecting and identifying patient physiological responses. BACKGROUND Monitoring patients by recording waveforms in response to stimulation delivered to the patients during surgery allows for early identification and prevention of impending injuries, such as a nerve injury. Generally, highly trained technologists under physician supervision may monitor patients during surgery using sophisticated, multichannel amplifiers and display equipment. Unfortunately, such personnel and equipment are costly and may be limited in their availability and/or require pre-booking. Such personnel may also subjectively analyze the waveforms during stressful circumstances, decreasing the accuracy, speed, and efficiency in detecting physiological responses, and thus leading to an increase in the risk of injury caused to patients during surgery. Detection of patient physiological responses and changes in the responses within the recorded waveforms may also be difficult, as such responses may be small, and the waveforms may include a large amount of ongoing noise signals. Thus, it may be difficult for technologists to recognize the patient physiological responses and to properly alert for changes in the patient physiological responses. This may lead to an increase in injuries caused to the patient during surgery. US 2014/0324118 A1 discloses devices and methods for treating medical disorders with evoked potentials and vagus nerve stimulation. SUMMARY Systems, methods, and articles of manufacture, including computer program products, are provided by the present disclosure for configuring a medical device and recommending medication dosages based at least in part on a health condition of a patient. For example, the system may provide more accurate medication preparation and delivery configurations and/or dosages for a patient to more effectively, efficiently, and quickly treat the patient. The invention is defined by claim 1. Additionally, a non-claimed method for detecting and identifying a patient physiological response is provided. The method may include stimulating, via a stimulating electrode coupled to a patient, one or more nerves of the patient. The method may also include recording, via a recording electrode coupled to the patient, a plurality of resultant electrical waveforms. The method may also include determining, based on the plurality of resultant electrical waveforms, whether at least a subset of the plurality of resultant electrical waveforms includes a patient physiological response. The determining may include comparing the subset of resultant electrical waveforms of the plurality of resultant electrical waveforms to a model waveform derived-sometimes in real-time-from a database of a plurality of template waveforms. The determining may also include determining, based on the comparison, one or more comparison features. The comparison feature(s) may indicate whether the patient physiological response exists in the subset of resultant electrical waveforms. The method may further include displaying, via a display, an indication that the patient physiological response exists in the subset of resultant electrical waveforms. In some aspects, the model waveform includes a predicted physiological response and a plurality of artifact signals. In some aspects, the comparison feature(s) further indicate(s) whether an artifact signal exists in the subset of resultant electrical waveforms. In some aspects, the method also includes displaying, via the display, an indication that the artifact signal exists in the subset of resultant electrical waveforms. In some aspects, the determining whether at least the subset of the plurality of resultant electrical waveforms includes the patient physiological response further includes labeling, based on the comparison feature(s), the subset of the plurality of resultant electrical waveforms with a positive label or a negative label. The positive label indicates that the patient physiological response exists and the negative label indicates that the patient physiological response does not exist. In some aspects, the determination of whether the plurality of resultant electrical waveforms includes the patient physiological response further includes: determining that the patient physiological response exists when the comparison feature(s) of the subset of electrical waveforms is within a threshold range of a threshold value of the comparison feature(s). In some aspects, the comparison feature(s) include(s) one or more of a means squared error between the subset of resultant electrical waveforms and the model waveform, a correlation between the subs