Abstract: Systems and methods which provide radial exterior weld terminal configurations for medical device leads are described. A radial exterior weld terminal may comprise an annular conductive structure having a radial exterior weld interface feature, wherein a medical device lead may comprise one or more radial exterior weld terminals. A radial exterior weld interface feature may be disposed at an end of the annular conductive structure and may configure the annular conductive structure to accept a non-axially directed portion of a conductive wire for interfacing a conductor with a weld location on an outer surface of the radial exterior weld terminal. The radial exterior weld interface feature may comprise a truncated aperture configured for the non-axially directed portion of conductive wire to traverse from the inner space to the outer surface. The truncated aperture may comprise a dimple member depressed into the interior space of the annular conductive structure.

Abstract: An implantable medical device (IMD) includes one or more stimulation engines (SEs) and selectively connectable output switching circuitry for driving a plurality of output nodes associated with a respective plurality of electrodes of the IMD's lead system when implanted in a patient. The output switching circuitry may be configured to facilitate self-test mode (STM) functionality in the IMD (e.g., when it is in a hermetically sealed package) by using a dual mode switch in series with a stimulation engine selection switch with respect to each output node in the output switching circuitry under mode selection control.

Abstract: The present disclosure provides systems and methods for wirelessly charging an implantable medical device. An external charging device includes a coil, signal generating circuitry to drive current through the coil at a charging frequency to induce current in a second coil in the implantable medical device, monitoring circuitry to generate an output signal to monitor charging operations, and a comb filter. The comb filter is configured to apply filtering to the output signal to remove noise from the output signal, wherein the filtering is applied based on the charging frequency. The external charging device is configured to process the filtered output signal to detect a circuit state of charging circuitry of the implantable medical device during charging operations, and the external charging device is configured to vary the charging frequency based, in part, on detection of the circuit state of the charging circuitry of the implantable medical device.

Abstract: This application is generally related to identifying or otherwise programming one or more cycling parameters for operation of an implantable pulse generator to provide a neurostimulation therapy to a patient using a non-paresthesia stimulation pattern. In some embodiments, the cycling parameter is selected by measuring physiological signals during trial stimulation. In other embodiments, multiple cycling parameters are identified for use by the patient using a patient controller device.

Abstract: A neurostimulation system is disclosed herein. The neurostimulation system includes an implantable pulse generator and an implantable therapy lead configured to be electrically coupled to the implantable pulse generator. The implantable therapy lead includes a flexible paddle electrode array with flexible electrodes. Each flexible electrode has a segmented configuration having first and second electrode segments and a flexible bridge or living hinge joining together the first and second electrode segments.

Abstract: The present disclosure provides systems and methods for generating burst waveforms. An implantable neurostimulation system includes an implantable stimulation lead including a plurality of contacts, and an implantable pulse generator communicatively coupled to the stimulation lead. The pulse generator is configured to generate a waveform including a burst that includes a leading anodic pulse followed by alternating cathodic pulses and anodic pulses, each cathodic pulse in the burst having a greater amplitude than the previous cathodic pulse.

Abstract: Paddle lead including a lead body having a distal end, a proximal end, and a central axis extending therebetween. The lead body includes opposite first and second sides that extend between the distal and proximal ends. The paddle lead also includes electrodes disposed along the first side of the lead body that are configured to apply neurostimulation therapy within an epidural space of a patient. The electrodes are electrically coupled to conductive pathways that extend through the proximal end of the lead body. The lead body includes a flexible material a flexible material that is configured to flex when a fluid pressure is imposed on the lead body in the epidural space. The lead body is configured to have a non-planar contour that folds or curves about the central axis when experiencing the fluid pressure.

Abstract: An implantable medical device (IMD) includes multiple stimulation engines for independently stimulating respective electrode sets of a lead system while avoiding collisions and/or channel contention during stimulation delivery. A first voltage multiplier is configured to generate an adjustable target voltage having sufficient headroom at an output node that is commonly coupled to anodic nodes of respective stimulation engines. Each stimulation engine includes a secondary voltage multiplier to drive the respective anode and a current regulator powered by a floating voltage supply, wherein the current regulator is coupled to a cathodic node and configured to control how much stimulation current is pulled from the patient tissue.

Abstract: A noninvasive/minimally invasive neuromodulation system and method for providing therapy to a target neural tissue of a patient. In one arrangement, an example method comprises applying at least two input waveforms to respective pairs of electrodes affixed on the patient's skin or subcutaneously disposed relative to the target neural tissue, wherein the frequencies of the input waveforms are configured such that they combine, when simultaneously applied, to generate a beat waveform having a beat frequency due to interference. The beat waveform is causative of a transcutaneous/subcutaneous temporal interference (T/STI) electric field generated in the patient body, the T/STI electric field including an interference region at least partially overlapping the target neural tissue of the patient, wherein the beat frequency is of a value operative to impart a therapeutic effect to the target neural tissue.

Abstract: A method of forming a stimulation lead includes forming an implantable lead body, including helically winding at least one cable about a mandrel to form a coiled cable assembly in a first, restrained state. Helically winding the at least one cable includes applying a tensile force to the at least one cable as the at least one cable is wound about the mandrel. Forming the lead body also includes releasing the tensile force from the at least one cable to allow the coiled cable assembly to release stored mechanical energy and transition from the restrained state to a second, relaxed state in which the coiled cable assembly is substantially free of stored mechanical energy. The method further includes subjecting the lead body to a reflow process by applying heat to the lead body, where the tensile force is released prior to the lead body being subjected to the reflow process.

Abstract: The present application relates to a new stimulation design which can be utilized to treat neurological conditions. The stimulation system produces a burst mode stimulation which alters the neuronal activity of the predetermined site, thereby treating the neurological condition or disorder. The burst stimulus comprises a plurality of groups of spike pulses having a maximum inter-spike interval of 100 milliseconds. The burst stimulus is separated by a substantially quiescent period of time between the plurality of groups of spike pulses. This inter-group interval may comprise a minimum of 5 seconds.

Abstract: An apparatus for use in peripheral nerve field stimulation (PNFS) whereby a plurality of curved introducer needles, of varying curvatures, are provided to permit the physician to best locate the region of oligodendrocytes that contain the A Beta fibers by matching the lumbar lordosis. A wing device is also provided that is attachable to the hub of the curved needle introducer which gives the physician better ability to maneuver the needle during insertion as well as permitting tenting of the skin. The invention benefits a large number of painful disorders arising from pathology in the cervical, thoracic, and lumbar spine. In addition, this invention can also help a large number of other conditions including but not limited to failed back surgery syndrome/post-laminectomy pain, occipital/suboccipital headaches, scar pain, post herpetic neuralgia pain, mononeuritis multiplex, and pain following joint surgery (e.g., knee, hip, shoulder).

Abstract: Stimulation lead includes an elongated lead body having distal and proximal ends and wire conductors extending therebetween. The stimulation lead also includes a lead paddle having a multi-dimensional array of electrodes positioned along a contact side of the lead paddle. The electrodes are electrically coupled to the wire conductors. The lead paddle includes a paddle body and a conductor organizer disposed within the paddle body. The conductor organizer has multiple channels extending along the lead paddle. The channels receive the wire conductors and retain the wire conductors in a designated arrangement with respect to the lead paddle. The conductor organizer has openings to the channels. The wire conductors extend through the openings and are terminated to the respective electrodes.

Abstract: A neurostimulation (NS) system and method are provided. The NS system includes an array of electrodes positioned within a patient. The array of electrodes includes an active electrode. The active electrode is configured to be a cathode electrode located proximate to neural tissue of interest that is associated with a target region. The NS system includes an anode electrode and an electromagnetic interference (EMI) antenna. A control circuit is configured to control delivery of a NS therapy during a therapy delivery interval. The NS therapy is to be delivered between the anode electrode and the active electrode. The NS system develops a residual voltage between the anode electrode and the active electrode over the therapy delivery interval. A current regulator (CR) circuit is connected to the cathode electrode. The CR circuit is configured to control current flow through the cathode electrodes.

Abstract: A system and method are provided that include a power supply having positive and negative terminals. The negative terminal defines a reference ground. First and second electrodes are positioned within a patient and configured to be located proximate to tissue of interest that is associated with a target region. A control circuit is configured to control delivery of current for a therapy between the first and second electrodes. A current regulator (CR) circuit is connected to, and configured to control current flow through, at least the first electrode during delivery of the therapy under direction of the control circuit. A floating power supply is connected across power supply terminals of the CR circuit. The CR circuit and floating power supply are coupled to a floating ground node that is electrically separate from the reference ground.

Abstract: Systems and methods which provide a bulkhead anchor configuration in which an anchor body includes flexure finger members and a radial bulkhead operable in cooperation to impart a radial compressive force to a corresponding lead body are described. A first portion of a bulkhead anchor body may comprise a plurality of flexure finger members disposed in a corolla configuration forming an anchor lumen through which a lead body may be inserted. A second portion of the bulkhead anchor body may comprise a radial bulkhead having a flexure profile configured to operatively engage the flexure finger members. A locking mechanism may be used to retain the first and second portions of the bulkhead anchor in their relative positions such that the radial compressive force is maintained upon the lead body indefinitely.

Abstract: The present disclosure provides systems and methods for managing communications in a remote therapy system. A method includes initiating a remote therapy session by establishing communications between a patient device and an implantable medical device implanted in a patient, and establishing communications between the patient device and a clinician device, determining, using the patient device, a distance between the patient and the patient device, comparing, using the patient device, the determined distance to a threshold distance, and managing the communications between the patient device and the implantable medical device based on the comparison.

Abstract: Systems and methods for enhancing or affecting neural stimulation efficiency and/or efficacy are disclosed. In one embodiment, a system and/or method may apply electromagnetic stimulation to a patient's nervous system over a first time domain according to a first set of stimulation parameters, and over a second time domain according to a second set of stimulation parameters. The first and second time domains may be sequential, simultaneous, or nested. Stimulation parameters may vary in accordance with one or more types of duty cycle, amplitude, pulse repetition frequency, pulse width, spatiotemporal, and/or polarity variations. Stimulation may be applied at subthreshold, threshold, and/or suprathreshold levels in one or more periodic, aperiodic (e.g., chaotic), and/or pseudo-random manners. In some embodiments stimulation may comprise a burst pattern having an interburst frequency corresponding to an intrinsic brainwave frequency, and regular and/or varying intraburst stimulation parameters.

Abstract: A system and method for facilitating DBS electrode trajectory planning using a machine learning (ML)-based feature identification scheme configured to identify and distinguish between various regions of interest (ROIs) and regions of avoidance (ROAs) in a patient's brain scan image. In one arrangement, standard orientation image slices as well as re-sliced images in non-standard orientations are provided in a labeled input dataset for training a CNN/ANN for distinguishing between ROIs and ROAs. Upon identification of the ROIs and ROAs in the patient's brain scan image, an optimal trajectory for implanting a DBS lead may be determined relative to a particular ROI while avoiding any ROAs.

Abstract: An implantable medical device (IMD) includes an adjustable capacitive voltage multiplier (CVM) that is responsive to diagnostic circuitry configured to provide control signals within a single stimulation current pulse for adjusting the voltage output applied to an electrode of the IMD's lead system. A control counter is coupled to the diagnostic circuitry for incrementing or decrementing an N-bit counter output signal operative to reconfigure a charge pump arrangement of the CVM so as to facilitate an adjusted voltage output.