Abstract: Digital-to-Analog (DAC) circuitry for an implantable pulse generator is disclosed which is used to program currents at the electrodes. Calibration circuitry allows the positive and negative currents produced at each electrode to be independently calibrated to achieve an ideal (linear) response across a range of amplitude values provided to the DAC circuitry by a digital amplitude bus. The calibration circuitry includes electrode gain and electrode offset circuitry for each of the electrodes. Current range DAC circuitry is also provided which can be used to adjust the gain and offset current at all of the electrodes. The current range DAC circuitry is particularly useful when spanning a range of therapeutic currents for a patient, and allows all possible amplitude values provided by the digital bus to be used to span the range. This can improve (reduce) the current resolution of the electrode currents with each amplitude value step.

Abstract: This document discusses, among other things, systems and methods for managing pain of a subject. A system includes a first sensor circuit to sense a first signal indicative of a functional state of the subject, a second sensor circuit to sense a second signal different from the first signal, and a controller circuit. The controller circuit may determine an operating mode of the second sensor circuit according to the sensed first signal, trigger the second senor circuit to sense the second signal under the determined operating mode, and generate a pain score using at least the second signal sensed under the determined operating mode. The pain score may be output to a patient or used for closed-loop control of a pain therapy.

Abstract: An example of a system for modulating neuroinflammation at a tissue site in a patient includes a neuromodulation output circuit, a memory, and a control circuit. The neuromodulation output circuit may be configured to deliver the neuromodulation. The memory may be configured to store a neuromodulation parameter set selected to modulate neural activity at the tissue site and a sensed biomarker parameter. The biomarker parameter may include a measure of a biomarker or a measure of a derivative of the biomarker. The biomarker may be indicative of the neuroinflammation at the tissue site. The control circuit may be configured to control the delivery of the neuromodulation using the neuromodulation parameter set and adjust one or more parameters of the neuromodulation parameter set using the biomarker parameter.

Abstract: A method of treating a patient and an external programmer for use with a neurostimulator. Electrical stimulation energy is conveyed into tissue of the patient via a specified combination of a plurality of electrodes, thereby creating one or more clinical effects. An influence of the specified electrode combination on the clinical effect(s) is determined. An anatomical region of interest is displayed in registration with a graphical representation of the plurality of electrodes. The displayed anatomical region of interest is modified based on the determined influence of the specified electrode combination on the clinical effect(s).

Abstract: A method, programmer for a neurostimulator, and neurostimulation kit are provided. The kit comprises a neurostimulator, and a plurality of elongated lead bodies configured for being coupled to the neurostimulator, each having a plurality of proximal contacts and a plurality of distal electrodes respectively electrically coupled to the proximal contacts, wherein an in-line connectivity between the electrodes and proximal contacts carried by the different lead bodies differs from each other. Electrical energy is conveyed between the electrodes of the selected lead body and the tissue, an electrical fingerprint is measured at the proximal contacts of the selected lead body in response to the conveyed electrical energy, and the selected lead body is identified based on the measured electrical fingerprint. These steps can be performed by the programmer.

Abstract: Methods for determining stimulation for a patient having a stimulator device are disclosed. A model is received at an external system indicative of a range or volume of preferred stimulation parameters, which model is preferably specific to and determined for the patient. The external system receives a plurality of pieces of fitting information for the patient, including information indicative of a symptom of the patient, information indicative of stimulation provided by the stimulator device during a fitting procedure, and/or phenotype information for the patient. The external system determines one or more sets of stimulation parameters for the patient using the pieces of fitting information. In one example, training data is applied to the pieces of fitting information to select the one or more sets of stimulation parameters from the range or volume of preferred stimulation parameters in the model.

Abstract: An operating room cable assembly for an electrical stimulation system that includes a lead connector having a housing, a lead lumen extending inwardly from a first opening in the housing and configured and arranged to receive a portion of a lead or lead extension, and a contact assembly disposed within the housing and configured and arranged to move relative to the housing. The contact assembly is configured and arranged to move to a load position and is biased to return to a lock position. The contact assembly includes of contacts that are configured and arranged to engage a portion of any lead or lead extension within the lead lumen when the contact assembly is in the lock position and to disengage from the portion of the lead or lead extension within the lead lumen when the contact assembly is in the load position.

Abstract: Methods and systems for testing and treating spinal cord stimulation (SCS) patients are disclosed. Patients are eventually treated with sub-perception (paresthesia free) therapy. However, supra-perception stimulation is used during “sweet spot searching” during which active electrodes are selected for the patient. This allows sweet spot searching to occur much more quickly and without the need to wash in the various electrode combinations that are tried. After selecting electrodes using supra-perception therapy, therapy is titrated to sub-perception levels using the selected electrodes. Such sub-perception therapy has been investigated using pulses at or below 10 kHz, and it has been determined that a statistically significant correlation exists between pulse width (PW) and frequency (F) in this frequency range at which SCS patients experience significant reduction in symptoms such as back pain.

Abstract: Methods and systems can facilitate identifying effective electrodes and other stimulation parameters, as well as determining whether to use cathodic and anodic stimulation. Alternately, the methods and systems may identify effective electrodes and other stimulation parameters based on preferential stimulation of different types of neural elements. These methods and systems can further facilitate programming an electrical stimulation system for stimulating patient tissue.

Abstract: An electrical stimulation system includes at least one electrical stimulation lead, each of the at least one electrical stimulation lead including a plurality of stimulation electrodes; and a processor coupled to the lead and configured to perform actions, including: directing delivery of at least one electrical pulse through at least one of the stimulation electrodes of the at least one electrical stimulation lead to tissue of a patient; and directing discrete or intermittent measurement of an electrical characteristic of the tissue using at least one of the stimulation electrodes of the at least one electrical stimulation lead during, and after, delivery of the at least one electrical pulse to the tissue of the patient.

Abstract: Methods and systems for providing neuromodulation to a patient are disclosed. The disclosed methods and systems use sensed neural responses to construct and optimize models of the neural elements recruited during the neuromodulation. The models are used to estimate neural recruitment associated with a therapeutic effect and/or with side-effects to stimulation. The models can be used to adjust neuromodulation in a closed-loop fashion.

Abstract: A system and method for selecting leadwire stimulation parameters includes a processor iteratively performing, for each of a plurality of values for a particular stimulation parameter, each value corresponding to a respective current field: (a) shifting the current field longitudinally and/or rotationally to a respective plurality of locations about the leadwire; and (b) for each of the respective plurality of locations, obtaining clinical effect information regarding a respective stimulation of the patient tissue produced by the respective current field at the respective location; and displaying a graph plotting the clinical effect information against values for the particular stimulation parameter and locations about the leadwire, and/or based on the obtained clinical effect information, identifying an optimal combination of a selected value for the particular stimulation parameter and selected location about the leadwire at which to perform a stimulation using the selected value.

Abstract: Passive tissue biasing circuitry in an Implantable Pulse Generator (IPG) is disclosed to facilitate the sensing of neural responses by holding the voltage of the tissue to a common mode voltage (Vcm). The IPG's conductive case electrode, or any other electrode, is passively biased to Vcm using a capacitor, as opposed to actively driving the (case) electrode to a prescribed voltage using a voltage source. Once Vcm is established, voltages accompanying the production of stimulation pulses will be referenced to Vcm, which eases neural response sensing. An amplifier can be used to set a virtual reference voltage and to limit the amount of current that flows to the case during the production of Vcm. In other examples, circuitry can be used to monitor the virtual reference voltage as useful to enabling the sensing the neural responses, and as useful to setting a compliance voltage for the current generation circuitry.

Abstract: Disclosed is a plug-in accessory for operating a mobile device as an external controller for an Implantable Medical Device (IMD). The accessory includes a connector insertable into a port on the mobile device. Accessory circuitry can be powered by a battery or by the mobile device. An application on the mobile device in conjunction with the accessory configures the mobile phone for immediate use as an IMD external controller. When the accessory is inserted into the port or a switch on the accessory pressed, the application operates to validate the accessory; to unlock the phone; to secure the mobile device; and to render a graphical user interface on the mobile device for communicating with the IMD. The accessory can additionally include telemetry circuitry and an antenna for communicating with the IMD, rather than using short-range communication means provided in the mobile device itself.

Abstract: A filtering algorithm implemented by a filtering module in an implantable medical device (IMD), or in an external device for communicating with an IMD, is disclosed which reviews blocks based on a number of rules. The filtering module preferably comprises both firewall and instruction analysis modules. The instruction analysis module analyzes the instructions and associated data (if present) in each block to determine whether such blocks would compromise operation of the IPG or injure a patient if executed. Instruction rules corresponding to an instruction identified in the block are retrieved by the instruction analysis module. The instruction analysis module reviews the block per the retrieved rules, and possibly also in light of current and historical IPG therapy setting or mode data, or other received but un-executed blocks. If a block is compliant, it is executed by the IMD or transmitted to the IMD.

Abstract: A computer implemented system and method provides a volume of activation (VOA) estimation model that receives as input two or more electric field values of a same or different data type at respective two or more positions of a neural element and determines based on such input an activation status of the neural element. A computer implemented system and method provides a machine learning system that automatically generates a computationally inexpensive VOA estimation model based on output of a computationally expensive system.

Abstract: An implantable stimulator device is disclosed for executing a stimulation program comprising a plurality of sub-programs, wherein the sub-programs are configured to be automatically sequentially executed by stimulation circuitry in the device. Control circuitry periodically stores log data to indicate where each sub-program is in its execution. If the device experiences an interruption that prevents the stimulation circuitry from executing the stimulation program, and upon receiving an indication that the stimulation circuitry can continue execution of the stimulation program, the control circuitry is configured to query the log data to determine a sub-program during which the interruption occurred, and using the log data, cause the stimulation circuitry to continue execution of the stimulation circuitry either at the beginning of the sub-program, or at a point during the sub-program when the interruption occurred.

Abstract: An example of a system for programming neurostimulation according to a stimulation configuration may include stimulation configuration circuitry, volume definition circuitry, stimulation effect circuitry, and recording circuitry. The stimulation configuration circuitry may be configured to determine the stimulation configuration. The volume definition circuitry may be configured to determine stimulation field model(s) (SFM(s)) each representing a volume of tissue activated by the neurostimulation. The stimulation effect circuitry may be configured to determine a stimulation effect type for each tagging point specified for the SFM(s) and to tag the SFM(s) at each tagging point with the stimulation effect type determined for that tagging point. The stimulation effect type for each tagging point is a type of stimulation resulting from the neurostimulation as measured at that tagging point.

Abstract: An example of a system may include electrodes on at least one lead configured to be operationally positioned for use in modulating a volume of neural tissue, where the neural tissue has an activation function. The system may further include a neural modulation generator configured to deliver energy using at least some electrodes to generate a modulation field within the volume of neural tissue. The neural modulation generator may be configured to use a programmed modulation parameter set to generate the modulation field. The programmed modulation parameter set having values selected to control energy delivery using the at least some electrodes to achieve an objective function specific to the activation function of the volume of neural tissue to promote uniformity of a response to the modulation field in the volume of neural tissue along a span of the at least one lead.

Abstract: A system for adjusting neuromodulation parameters used by a neuromodulator operably connected to a plurality of electrodes to modulate a neural target, may comprise a translation trigger detector configured to determine that a translation trigger has occurred, a first parameter setting storage configured to store first parameter settings for use by the neuromodulator to modulate the neural target, and a neuromodulation parameter translator. The neuromodulation parameter translator may be operably connected to the translation trigger detector to automatically translate the first parameter settings into a second parameter settings in response to determining the translation trigger has occurred, and replace the first parameter settings with the second parameter settings, or store the second parameter settings in a second parameter setting storage.