Abstract: A field measurement algorithm and measuring circuitry in an implantable stimulator, and an field modelling algorithm operable in an external device, are used to determine an electric field in a patient's tissue. The field measuring algorithm provides at least one test current between two electrodes, and a plurality of voltage differentials are measured at different combinations of the electrodes. The voltage differential data is telemetered to the field modelling algorithm which determines directional resistance at different locations in the patient's tissue. The field modelling algorithm can then use a stimulation program selected for the patient and the determined directional resistances to determine voltages in the patient's tissue at various locations, which in turn can be used to model a more-accurate electric field in the tissue, and preferably to render an electric field image for display in a graphical user interface of the external device.

Abstract: A method of treating a patient and on 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: An external control device, neuromodulation system, and method of providing therapy to a patient using an implantable neuromodulator implanted within the patient. Electrical modulation energy is delivered from the neuromodulator to the patient in accordance with the pre-existing modulation program when in one of the super-threshold delivery mode and the sub-threshold delivery mode. Operation of the neuromodulator is switched to the other of the super-threshold delivery mode and the sub-threshold delivery mode. A new modulation program may be derived from a pre-existing modulation program, and the neuromodulator may deliver the electrical modulation energy to the patient in accordance with the pre-existing modulation program during the other of the super-threshold delivery mode and the sub-threshold delivery mode.

Abstract: An example of a system for delivering neurostimulation using a stimulation device and controlling the delivery of the neurostimulation may include a programming control circuit and a stimulation control circuit. The programming control circuit may be configured to program the stimulation device for delivering the neurostimulation according to a pattern of neurostimulation pulses defined by one or more stimulation waveforms. The stimulation control circuit may be configured to determine the pattern of neurostimulation pulses with the one or more stimulation waveforms constrained by one or more thresholds, and may include threshold circuitry that may be configured to receive one or more known values of the one or more thresholds and to determine needed values of the one or more thresholds by executing an algorithm allowing for prediction of the needed values of the one or more thresholds based on the one or more known values.

Abstract: An example of a system for delivering neurostimulation may include a programming control circuit and a user interface. The programming control circuit may be configured to generate stimulation parameters controlling delivery of neurostimulation pulses according to one or more stimulation waveforms associated with areas of stimulation each defined by a set of electrodes. The neurostimulation pulses are each delivered to an area of stimulation. The user interface may include a display screen and an interface control circuit. The interface control circuit may be configured to define the one or more stimulation waveforms and the areas of stimulation, and may include a stimulation frequency module configured to display a stimulation rate table on the display screen. The stimulation rate table may present stimulation frequencies associated with each of the areas of stimulation for selection by a user.

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: A system may include at least one sensor configured to bilaterally sense neurophysiological signals from the patient to provide bilateral sensing data, and at least one processor configured to calibrate at least a first electrode contact and a second electrode contact on the least one neuromodulation lead, including: instruct the neuromodulation device to deliver neuromodulation energy using at least the first electrode contact to cause a first neurophysiological response and at least the second electrode contact to cause a second neurophysiological response; receive from the at least one sensor first bilateral sensed data corresponding to the first neurophysiological response and second bilateral sensed data corresponding to the second neurophysiological response; and determine based on the first and second neurophysiological responses at least one of: physiological midline information or electrode-tissue coupling information.

Abstract: Systems and methods for determining a parameter set and programming a neuromodulation system with the parameter set are disclosed. The system includes a user interface having a display screen to display simplified graphical representations (SGRs) of the lead with at least one virtual electrode (VE) that represents one or more electrodes, and control elements. The SGRs of the lead can provide longitudinal and circumferential representations of the VE, respectively representing longitudinal or circumferential position, size, shape, or spread of the VE. The control elements may include longitudinal and circumferential control elements to enable the user to respectively adjust the longitudinal or circumferential position, size, shape, or spread of the VE. The system may generate the neuromodulation parameter set using the longitudinal and circumferential representations of the VE, and program the neuromodulation system with the neuromodulation parameter set.

Abstract: Methods and systems can facilitate visualizing cathodic and anodic stimulation separately. Alternately, the methods and systems may separately visualize stimulation of different neural elements, such as nerve fibers and neural cells. These methods and systems can further facilitate programming an electrical stimulation system for stimulating patient tissue.

Abstract: A system and method for securing an implantable medical device to an anatomical feature, such as bony structures and/or soft tissues near the spine. The system includes a tissue fixation device and a tissue fixation device delivery tool. The tissue fixation device includes at least one bone or tissue anchor and a connecting element coupled thereto. The tissue fixation device optionally includes a flexible anchoring strap for engaging the implantable medical device. The bone or tissue anchor are configured to be deployed into the anatomical feature, and the connecting element is tightened to secure the implantable medical device to the anatomical feature.

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: An architecture is disclosed for an Implantable Pulse Generator having improved compliance voltage monitoring and adjustment software and hardware. Software specifies which stimulation pulses are to be measured as relevant to monitoring and adjusting the compliance voltage. Preferably, specifying such pulses occurs by setting a compliance monitoring instruction (e.g., a bit) in the program that defines the pulse, and the compliance monitor bit instruction may be set at a memory location defining a particular pulse phase during which the compliance voltage should be monitored. When a compliance monitor instruction issues, the active electrode node voltages are monitored and compared to desired ranges to determine whether they are high or low. Compliance logic operates on these high/low signals and processes them to decide whether to issue a compliance voltage interrupt to the microcontroller, which can then command the compliance voltage generator to increase or decrease the compliance voltage.

Abstract: Software for providing a Graphical User Interface (GUI) for use in a clinician programmer for programming an implantable pulse generator (IPG) or external trial stimulator (ETS) is disclosed. A user may define in the GUI multiple pole configurations (e.g., monopoles, bipoles, etc.) which may be used independently to provide stimulation to a patient via the IPG or ETS's electrode array. Selected of the pole configurations can be linked or associated as a group in the GUI and used to concurrently provide stimulation. The pole configuration group may be steered or moved in the electrode array using a single movement instruction which moves all pole configurations in the group simultaneously. This allows the relative positions of the pole configurations in the group to remain constant as the group is moved.

Abstract: Methods and systems for programming implantable stimulation devices are disclosed. The disclosed techniques may be applied to a programming interface associated with a clinician's programmer, for example. A user interface allows a user to select stimulation waveforms to be applied at a plurality of electrodes implanted in a patient and to visualize how the waveforms interact with each other and with the patient's tissue. For example, the user interface can display a representation of constructive and destructive activation interactions and can also display time-resolved spatiotemporal behavior during stimulation.

Abstract: Systems and methods are disclosed in which an external device such as a consumer mobile device (e.g., smart phone) is used as an external controller to bi-directionally communicate with an Implantable Medical Device (IMD) using a dedicated patient remote control (RC) as an intermediary device to translate communications between the two. The dedicated RC contains a graphical user interface allowing for control and monitoring of the IMD even if the mobile device is not present in the system, which is useful as a back-up should the mobile device experience problems. Use of the dedicated RC as an intermediary device broadens the utility of other computing devices to operate as an external controller for an IMD even if the computing device and IMD do not have compliant communication means.

Abstract: A method and system of providing therapy to a patient implanted with an array of electrodes is provided. A train of electrical stimulation pulses is conveyed within a stimulation timing channel between a group of the electrodes to stimulate neural tissue, thereby providing continuous therapy to the patient. Electrical parameter is sensed within a sensing timing channel using at least one of the electrodes, wherein the first stimulation timing channel and sensing timing channel are coordinated, such that the electrical parameter is sensed during the conveyance of the pulse train within time slots that do not temporally overlap any active phase of the stimulation pulses.

Abstract: Techniques for sensing neural responses such as Evoked Compound Action Potentials (ECAPs) in an implantable stimulator device are disclosed. A first therapeutic pulse phase is followed by a second pulse phase, which phases may be of opposite polarities to assist with active charge recovery. The second pulse phase is formed so as to overlap in time with the arrival of the ECAP at a sensing electrode, which second phase may generally be longer and of a lower amplitude. In so doing, a stimulation artifact formed in a patient's tissue is rendered constant, and of a smaller amplitude, when the ECAP is sensed at the sensing electrode, which eases sensing by a sense amp circuit. Passive charge recovery may follow the second phase, which will not interfere with ECAP sensing that has already occurred.

Abstract: Methods and systems for providing neuromodulation therapy are disclosed. The methods and systems are configured to sense an evoked neural response and use the evoked neural response as feedback for providing neuromodulation therapy. Methods of reducing stimulation artifacts that obscure the sensed evoked neural response are disclosed. The methods of artifact reduction include recording a stimulation artifact in the absence of an evoked neural response, aligning and scaling the stimulation artifact with respect to the obscured signal, and subtracting the aligned and scaled artifact from the obscured signal.

Abstract: An example of a neurostimulation system may include a storage device, a programming control circuit, and a graphical user interface (GUI). The storage device may be configured to store individually definable waveforms. The programming control circuit may be configured to generate stimulation parameters controlling the delivery of the neurostimulation pulses according to a pattern. The GUI may be configured to define the pattern using one or more waveforms selected from the individually definable waveforms. The GUI may display waveform tags each selectable for access to a waveform of the individually definable waveforms, and display a waveform builder in response to selection of one of the waveform tags. The waveform builder may present a graphical representation of the accessed waveform and allow for the accessed waveform to be adjusted by editing the graphical representation of the accessed waveform on the GUI.

Abstract: A method for manufacturing a lead includes forming an elongated multi-lumen conductor guide defining a central stylet lumen and a plurality of conductor lumens arranged around the stylet lumen. The multi-lumen conductor guide is twisted to form at least one helical section where the plurality of conductor lumens each forms a helical pathway around the stylet lumen. Each of the helical pathways of the at least one helical section has a pitch that is no less than 0.04 turns per centimeter.