Abstract: A wearable article for receiving and retaining a charger for charging a medical device implanted into a patient includes a coil-assembly cavity and first and second controller cavities defined between first and second major surfaces of a body of the wearable article. The coil-assembly cavity is configured to retain a coil assembly of the charger, and the first and second controller cavities are each configured to receive at least a portion of a controller of the charger. A controller slit is defined along the first major surface and is open to both the first and second controller cavities. The first controller cavity is configured to receive at least a portion of the controller with a user interface of the controller extending or observable through the controller slit or disposed in the second controller cavity.

Abstract: An electrical stimulation system for use with a plurality of electrodes implanted within a tissue region comprises a neurostimulator configured for delivering electrical stimulation energy to the plurality of electrodes in accordance with a set of stimulation parameters, thereby injecting a charge into the tissue region, a control device configured for receiving user input to modify the set of stimulation parameters, and controller/processor circuitry configured for, in response to the user input computing a charge injection metric value as a function of a physical electrode parameter and an electrical source parameter for a first set of the electrodes, wherein the electrode set comprises at least two electrodes, comparing the computed charge injection metric value to a safety threshold value, and performing a corrective action based on the comparison.

Abstract: A system for programming electrical stimulation by a lead includes a processor coupled to a display. The processor presents an interface on the display with user-selectable controls to define stimulation fields and repeating stimulation patterns for delivering the stimulation fields temporally-coordinated with each other. The user-selectable controls include a field control to define the number of stimulation fields, a location control to define locations of the stimulation fields relative to the lead, a repetition control to define a repetition frequency of the stimulation patterns, and a temporal-adjustment control to define temporal adjustments of the stimulation fields.

Abstract: An Implantable Pulse Generator (IPG) is disclosed that is capable of sensing a degree to which recruited neurons in a patient's tissue are firing synchronously, and of modifying a stimulation program to promote desynchronicity and to reduce paresthesia. An evoked compound action potential (ECAP) of the recruited neurons is sensed as a measure of synchronicity by at least one non-active electrode. An ECAP algorithm operable in the IPG assesses the shape of the ECAP and determines one or more ECAP shape parameters that indicate whether the recruited neurons are firing synchronously or desynchronously. If the shape parameters indicate significant synchronicity, the ECAP algorithm can adjust the stimulation program to promote desynchronous firing.

Abstract: An Example of a system for providing a patient with pain management may include a sleep monitoring circuit, a pain relief device, and a control circuit. The sleep monitoring circuit may be configured to sense one or more sleep signals from the patient and to determine a sleep state of the patient using the one or more sleep signals. The one or more sleep signals may include one or more physiological signals corresponding to the sleep state of the patient. The pain relief device may be configured to deliver one or more pain relief therapies. The control circuit may be configured to control the delivery of the one or more pain relief therapies using therapy parameters and to adjust the therapy parameters based on the determined sleep state.

Abstract: An external control device for use with a neurostimulator coupled to a plurality of electrodes capable of conveying electrical stimulation energy into tissue in which the electrodes are implanted. The external control device comprises a user interface including at least one control element, a processor configured for independently assigning stimulation amplitude values to a first set of the electrodes, for linking the first set of electrodes together in response to the actuation of the at least one control element, and for preventing the stimulation amplitude values of the first linked set of electrodes from being varied relative to each other, and output circuitry configured for transmitting the stimulation amplitude values to the neurostimulator.

Abstract: A charging system for an Implantable Medical Device (IMD) is disclosed having a charging coil and one or more sense coils. The charging coil and one or more sense coils are preferably housed in a charging coil assembly coupled to an electronics module by a cable. The charging coil is preferably a wire winding, while the one or more sense coils are concentric with the charging coil and preferably formed in one or more traces of a circuit board. One or more voltages induced on the one or more sense coils can be used to determine whether the charging coil is (i) centered, (ii) not centered but not misaligned, or (iii) misaligned, with respect to the IMD being charged, which three conditions sequentially comprise lower coupling between the charging coil and the IMD. A charging algorithm is also disclosed that control charging dependent on these conditions.

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: One embodiment is a lead introducer including an outer needle, an inner needle, a splittable member, and an annular seal member. The outer needle, inner needle, and splittable member each include a body and hub. The splittable member fits over the outer needle body and the inner needle body and can be separated longitudinally. The splittable member hub receives at least portions of both the inner needle hub and the outer needle hub within the splittable member hub. The annular seal member is formed by either a) the inner needle hub or b) a combination of the inner needle hub and outer needle hub. The annular seal member forms a fluid-resisting seal with the interior surface of the splittable member hub when the portions of the inner needle hub and outer needle hub are received within the splittable member hub.

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: An example of a system may include an electrode arrangement and a neuromodulation device configured to use electrodes in the electrode arrangement to generate a neuromodulation field. The neuromodulation device may include a neuromodulation generator, a neuromodulation control circuit and a storage. The storage may include a stochastically-modulated neuromodulation parameter set and the stochastically-modulated neuromodulation parameter set may include at least one stochastically-modulated parameter. The controller may be configured to control the neuromodulation generator using the stochastically-modulation parameter set to generate the neuromodulation field.

Abstract: A therapeutic neuromodulation system configured for providing therapy to a patient. The therapeutic neuromodulation system comprises a plurality of electrical terminals configured for being respectively coupled to a plurality of electrodes implanted within tissue, analog output circuitry configured for delivering therapeutic electrical energy between the plurality of electrical terminals in accordance with a set of modulation parameters that includes a defined current value, a voltage regulator configured for supplying an adjustable compliance voltage to the analog output circuitry, and control/processing circuitry configured for automatically performing a compliance voltage calibration process at a compliance voltage adjustment interval by periodically computing an adjusted compliance voltage value as a function of a compliance voltage margin.

Abstract: This document discusses, among other things, systems and methods for managing pain in a subject. A system may include one or more sensors configured to sense from the subject information corresponding to emotional reaction to pain, such as emotional expression. The emotional expression includes facial or vocal expression. A pain analyzer circuit may generate a pain score using signal metrics of facial or vocal expression extracted from the sensed information. The pain score may be output to a user or a process. The system may additionally include a neurostimulator that can adaptively control the delivery of pain therapy by automatically adjusting stimulation parameters based on the pain score.

Abstract: Medical device systems and methods for providing spinal cord stimulation (SCS) are disclosed. The SCS systems and methods provide therapy below the perception threshold of the patient. The methods and systems are configured to measure neurological responses to stimulation and use the neurological responses as biomarkers to maintain and adjust therapy. An example of neurological responses includes an evoked compound action potential (ECAP).

Abstract: An implantable control module for an electrical stimulation system includes a housing and a connector shell extending into the housing. The housing and the connector shell collectively form a sealed cavity. The connector shell has a longitudinal length, a sidewall with a cavity-facing surface, a first end open to an environment external to the housing, and an opposing closed second end. The connector shell defines a connector lumen extending within the connector shell and open at the first end to receive a portion of a lead or lead extension. Connector contacts are arranged along the connector lumen within the connector shell. An electronic subassembly is disposed in the sealed cavity. Interconnect conductors electrically couple the electronic subassembly to the connector contacts and extend from the connector shell within the sealed cavity.

Abstract: A group select matrix is added to an implantable stimulator device to allow current sources to be dedicated to particular groups of electrodes at a given time. The group select matrix can time multiplex the current sources to the different groups of electrodes to allow therapy pulses to be delivered at the various groups of electrodes in an interleaved fashion. Each of the groups of electrodes may be confined to a particular electrode array implantable at a particular non-overlapping location in a patient's body. A switch matrix can be used in conjunction with the group select matrix to provide further flexibility to couple the current sources to any of the electrodes.

Abstract: Techniques for determining the location of a physiological midline are disclosed. A first technique evaluates the response to stimulation of spinal electrodes at peripheral electrodes on different sides of the body. In this technique, a spinal electrode's position relative to a physiological midline is determined based on a relationship between responses to its stimulation observed on different sides of the body. A second technique evaluates the response of spinal electrodes to stimulation of peripheral electrodes on different sides of the body. In this technique, a spinal electrode's position relative to a physiological midline is determined based on the different responses that it observes to stimulation on different sides of the body.

Abstract: An example of a system for delivering neurostimulation may include a programming control circuit and a stimulation control circuit. The programming control circuit may be configured to generate stimulation parameters controlling delivery of the neurostimulation according to a stimulation configuration. The stimulation control circuit may be configured to specify the stimulation configuration, and may include volume definition circuitry and stimulation configuration circuitry. The volume definition circuitry may be configured to determine one or more test volumes, determine a clinical effect resulting from the one or more test volumes each being activated by the neurostimulation, and determine a target volume using the determined clinical effect. The stimulation configuration circuitry may be configured to generate the specified stimulation configuration for activating the target volume.

Abstract: Methods and systems for selecting electrical stimulation parameters for an electrical stimulation device implanted in a patient can use an iterative process for identifying electrodes for stimulation, as well as suitable stimulation parameters. The process begins with an initial set of electrode combinations to identify regions of the nerve or other tissue for stimulation. This leads to selection of other electrode combinations to test, followed by the selection of multiple electrode groups (which can include three or more electrodes) for stimulation.

Abstract: A lead assembly includes a lead or lead extension having terminals and a mechanical stop fixed to the lead or lead extension and located distally to the plurality of terminals. The lead assembly also includes a connector having a connector housing, a connector block disposed within the connector housing, a port defined at the distal surface of the connector housing, a lumen extending from the port for receiving a portion the lead or lead extension, and contacts disposed within the connector housing. The outer diameter of the mechanical stop is larger than the lumen diameter within the connector block to halt further insertion of the lead or lead extension into the connector housing. Additionally or alternatively, a visually distinctive marking can be applied to the lead or lead extension to indicate alignment between the terminals of the lead and the contacts of the connector.