Abstract: There is provided a method and implantable device for controlling a neural stimulus, the neural stimulus being defined by an artefact mitigation status. The method comprises generating a first neural stimulus for delivery to neural tissue, sensing a first signal subsequent to the first neural stimulus, generating a second neural stimulus for delivery to the neural tissue, and sensing a second signal subsequent to the second neural stimulus. The method further comprises determining an artefact mitigation measure (AMM) effect level based on the first sensed signal and the second sensed signal, and setting, in response to comparing the AMM effect level with an AMM effect threshold, the artefact mitigation status of a third neural stimulus to active.

Abstract: A neuromodulation device comprises stimulus electrodes and sense electrodes. A stimulus source provides stimuli to evoke a neural response on a neural pathway. A signal sensed at the sense electrodes includes an evoked neural response. A control unit controls the stimulus source to provide the neural stimulus according to a stimulus intensity parameter; measures an intensity of the evoked response; and completes a feedback loop using the measured intensity and controller parameters to control the stimulus intensity parameter to maintain the measured intensity at a target value. Optimal values of the controller parameters are determined from a representative value of a characteristic of the feedback loop, the representative value having been derived from data of previously programmed patients, and/or the processor is configured to determine optimal values of the one or more controller parameters from a predetermined value of an amplification parameter of the feedback loop.

Abstract: In some implementations, the device may include a neural stimulation system having: an implantable closed-loop neural stimulation device for controllably delivering neural stimuli via one or more stimulus electrodes, the device having the one or more stimulus electrodes and a feedback controller configured to adjust a stimulus intensity parameter so as to maintain a measured neural response intensity at a target response intensity; and a processor configured to: estimate an out-of-compliance current limit for each of the one or more stimulus electrodes; estimate a closed-loop current requirement for the implantable closed-loop neural stimulation device; compare the out-of-compliance current limit for each of the one or more stimulus electrodes to the closed-loop current requirement; and take a mitigating action based on the comparison.

Abstract: Disclosed is a neural stimulation system and method. A neural stimulus is delivered according to a stimulus intensity parameter; and a signal window is captured from a signal sensed on neural tissue by a recording electrode subsequent to the neural stimulus. A plurality of signal windows are captured from signals sensed on the neural tissue by a first recording electrode subsequent to respective neural stimuli delivered according to respective stimulus intensity parameter values. Repeatedly, for each candidate detector in a set of candidate detectors: the candidate detector is used to measure intensities of evoked neural responses in the captured signal windows; and derive a metric for the candidate detector from the measured neural response intensities; and select a candidate detector for the first recording electrode from the set of candidate detectors based on their respective metrics.

Abstract: Disclosed is an implantable device for controllably delivering neural stimuli. The device comprises: a plurality of electrodes including one or more stimulus electrodes and one or more measurement electrodes; a stimulus source configured to provide neural stimuli to be delivered via the one or more stimulus electrodes to a neural pathway of a patient in order to evoke neural responses from the neural pathway; measurement circuitry configured to capture signal windows sensed on the neural pathway via the one or more measurement electrodes subsequent to respective neural stimuli; and a control unit configured to: control the stimulus source to provide a neural stimulus according to a stimulus intensity parameter; and measure an intensity of an evoked neural response in a signal window capture subsequent to the provided neural stimulus by correlating the captured signal window with a template.

Abstract: A neuromodulation device comprises stimulus electrodes and sense electrodes. A stimulus source provides stimuli to evoke a neural response on a neural pathway. A signal sensed at the sense electrodes includes an evoked neural response. A control unit controls the stimulus source to provide the neural stimulus according to a stimulus intensity parameter; measures an intensity of the evoked response; and completes a feedback loop using the measured intensity and controller parameters to control the stimulus intensity parameter to maintain the measured intensity at a target value. Optimal values of the controller parameters are determined from a representative value of a characteristic of the feedback loop, the representative value having been derived from data of previously programmed patients, and/or the processor is configured to determine optimal values of the one or more controller parameters from a predetermined value of an amplification parameter of the feedback loop.

Abstract: Disclosed is a method of adapting the operation of an implantable device for delivering neurostimulation therapy to a patient. The method comprises: delivering the neurostimulation therapy to electrically excitable tissue of the patient according to at least one therapy parameter; measuring a physiological characteristic of the patient; adjusting the at least one therapy parameter according to a schedule of adjustment and the measured physiological characteristic; and repeating the delivering, measuring, and adjusting.

Abstract: Disclosed is a neurostimulation system and method. A control unit controls a stimulus source to deliver neural stimuli via selected electrodes to a neural pathway according to a stimulus intensity parameter. An external computing device in communication with the neurostimulation device comprises a display and processor. The processor initialises the stimulus intensity parameter, and renders on the display a stimulation control and a graphical element adjacent the stimulation control. Upon user activation of the stimulation control, the processor ramps a value of the stimulus intensity parameter, while instructing the control unit to cause delivery of stimuli according to the ramping value of the stimulus intensity parameter. Upon user deactivation of the stimulation control, the processor ceases ramping the value of the stimulus intensity parameter.

Abstract: Disclosed is a method of computing a probability distribution of the suitability of measurement electrode configurations for a neuromodulation device. The method comprises: computing the probability distribution of suitability of measurement electrode configurations from: a predetermined stimulus program vector of the neuromodulation device; and prior patient data. Also disclosed is an automated method of setting a measurement electrode configuration for a neuromodulation device configured to deliver a neural stimulus to a neural pathway of a patient.

Abstract: Disclosed is a neurostimulation system comprising an implantable device for controllably delivering a neural stimulus, and a processor. Signals evoked by a stimulus are sensed at each pair of sense electrodes, each sensed signal including a differential evoked compound action potential (ECAP) evoked by the delivered neural stimulus. The differential ECAP is decomposed in each sensed signal into a first single-ended ECAP corresponding to one sense electrode of the pair of sense electrodes and a second single-ended ECAP corresponding to the other sense electrode of the pair of sense electrodes. ECAP propagation model parameters are determined from the first single-ended ECAP model and the second single-ended ECAP model and from distances of the respective sense electrodes from the stimulus electrode configuration. An indication may be given to a user if one of the one or more ECAP propagation model parameters departs from a predetermined range.

Abstract: An implantable neuromodulation device (100) that includes a plurality of stimulus electrodes, measurement electrodes, a stimulus source and measurement circuitry (128). The device also includes a control unit (116) configured to: control the stimulus source to provide a neural stimulus to a neural pathway (180) according to a stimulus intensity parameter; measure an intensity of the evoked neural response in captured signal windows; determine a feedback variable from the measured intensity of the evoked neural response; implement a feedback loop by using the feedback variable to control the stimulus intensity parameter so as to maintain the feedback variable at a target value; convert (1404) a loop variable of the feedback loop to a representation, where the representation is one of a time-domain representation and a frequency-domain representation; and analyse (1406) the representation to determine a loop stability measure of the feedback loop.

Abstract: Disclosed is an electrode lead assembly comprising an electrode lead body and a plurality of electrodes arranged along a length of the body. The plurality of electrodes comprising a first group of electrodes and a second group of electrodes, wherein adjacent pairs of electrodes in each group of electrodes have a respective electrode pitch. The first group and the second group of electrodes each comprise at least one electrode configurable as a stimulus electrode for delivering stimulation to a neural target and at least one electrode configurable as a measurement electrode for measuring a response evoked by the delivered stimulation. The first group of electrodes is separated from the second group of electrodes by an electrode-free lead portion, the electrode-free lead portion having a length that is greater than each electrode pitch of the first group of electrodes and greater than each electrode pitch of the second group of electrodes.

Abstract: A neural stimulation system comprising: a neuromodulation device for delivering neural stimuli, and a processor. The neurostimulation device comprises: a plurality of electrodes; a stimulus source to provide neural stimuli to be delivered via the electrodes to a neural tissue to evoke neural responses; measurement circuitry configured to capture signal windows sensed at the electrodes subsequent to respective neural stimuli; and a control unit configured to control the stimulus source to provide each neural stimulus according to a stimulus intensity parameter. The processor is configured to: instruct the control unit to control the stimulus source to sequentially provide a plurality of neural stimuli according to a ramp of stimulus intensity parameter values up to a perceptual marker; receive a captured signal window subsequent to each neural stimulus; detect whether an evoked neural response is present in each signal window; and determine the perceptual marker based on the detecting.

Abstract: Disclosed is a method of adapting the operation of an implantable device for delivering neurostimulation therapy to a patient. The method comprises: delivering the neurostimulation therapy to electrically excitable tissue of the patient according to at least one therapy parameter; measuring a physiological characteristic of the patient; adjusting the at least one therapy parameter according to a schedule of adjustment and the measured physiological characteristic; and repeating the delivering, measuring, and adjusting.

Abstract: A method of evaluating spinal cord stimulation (SCS), comprising obtaining neural response data generated by a spinal cord stimulator, where the neural response data describes one or more neural signals evoked in the spinal cord of a patient by applying diagnostic stimuli. One or more evoked compound action potentials (ECAPs) associated with the respective one or more neural signals are detected. The one or more detected ECAPs are processed to generate one or more evaluation metrics, and the one or more evaluation metrics are used to generate a confidence score indicating a degree of effectiveness of SCS on the patient.

Abstract: Disclosed is an automated programming system for a neuromodulation device that is configured to assist a clinician to efficiently program the neuromodulation device for a particular patient. In particular, the assisted programming system comprises a stimulation user interface control that is configured to cause the intensity of the neural stimulus to ramp up with time as long as the patient continues to interact with the control. The value of stimulus intensity at which the patient ceases to interact with the control is recorded as a significant perceptual marker upon which subsequent steps in the assisted programming workflow are based. This user interface design takes advantage of the human withdrawal reflex, whereby the patient is likely to instinctively release the button upon receiving uncomfortable stimulation. The design therefore minimises the training burden placed on the patient in using the assisted programming system.

Abstract: Disclosed is an assisted programming system for a neuromodulation device that is configured to assist a clinician to efficiently program the neuromodulation device for a particular patient. In particular, the assisted programming system comprises a processor configured to ramp a stimulus intensity parameter to or from a predetermined target intensity while the neural stimuli are delivered by the device according to the ramping value of the stimulus intensity parameter. The ramp traverses stimulus intensities below a predetermined threshold at a faster rate than stimulus intensities above the predetermined threshold. The effect is to improve the apparent responsiveness of the neuromodulation device by reducing the amount of time spent traversing stimulus intensities below a perception threshold, while avoiding a sensation of abruptness.

Abstract: Disclosed is an assisted programming system for a neuromodulation device that is configured to assist a clinician to efficiently program the neuromodulation device for a particular patient. In particular, the assisted programming system comprises a processor configured to predict physiological thresholds of a particular stimulus electrode configuration from perceptual markers obtained using patient reported responses to neural stimuli via that stimulus electrode configuration. Alternatively, the processor may be configured to predict perceptual markers of a particular stimulus electrode configuration from physiological thresholds obtained using measured neural responses to neural stimuli delivered via that stimulus electrode configuration.

Abstract: Disclosed is an assisted programming system for a neuromodulation device that is configured to assist a clinician to efficiently program the neuromodulation device for a particular patient. In particular, the assisted programming system comprises a user interface with a plurality of controls such as switches, each switch control corresponding to a predetermined configuration of the stimulus electrodes. Activation and de-activation of the switch controls causes stimuli to be delivered via the respective stimulus electrode configurations. Alternatively, or additionally, the user interface controls may be tiles, whose activation may cause the state of delivery of stimulation via the respective stimulus electrode configurations to be inverted.

Abstract: Disclosed are methods and devices for analysing signal windows captured subsequent to delivered neural stimuli and for providing a quality score for each signal window. The quality score is indicative of how closely the captured signal window resembles, or how likely that the captured signal window contains, an ECAP. The quality score may be provided to a process supervising a feedback loop of the closed-loop neural stimulation device delivering the stimuli and capturing the signal windows to ensure the delivered stimuli are appropriate. For example, if the score falls below a predetermined threshold, the supervisor may take a mitigation action to prevent inappropriate adjustment to the intensity of the delivered stimuli by the feedback loop, such as suspending operation of the feedback loop.