Boston Scientific Neuromodulation Corporation

Lee, Dongchul

Parramon, Jordi

Grandhe, Sarvani

Doan, Que T.

Kothandaraman, Sridhar

Gillespie, Christopher Ewan

Que T Doan

Michael A Moffitt

Changfang Zhu

Ismael Huertas Fernandez

Rosana Esteller

Tianhe Zhang

Jianwen Gu

Sridhar Kothandaraman

David K L Peterson

Rafael Carbunaru

Bradley Lawrence Hershey

Yuping He

Jordi Parramon

Christopher Ewan Gillespie

Dongchul Lee

Jess Weiqian Shi

Dennis Allen Vansickle

Adam Thomas Featherstone

Jess Weigian Shi

Luca A Annecchino

Sarvani Grandhe

Justin Holley

Matthew Lee Mcdonald

Luca Antonello Annecchino

Dennis Vansickle

Nazim Wahab

David KL Peterson

An algorithm for determining optimal sub-perception stimulation parameters for a Spinal Cord Stimulation patient is disclosed. The algorithm uses various modelling information, including a model determined based on empirical testing that relates optimal frequencies and pulse widths with perception thresholds reported by patients at those frequencies and pulse widths. A patient's perception threshold is then measured at different pulse widths, with the result compared to the model to determine a range or volume in the model that best relates frequency pulse width and perception threshold for that patient. Further modeling allows the perception thresholds to be related to an optimal amplitudes, thus resulting in optimal situation parameters (F, PW, and A) for the patient. The optimal stimulation parameters may be provided to a patient's external controller to allow the patient to adjust stimulation within a range of volume of these parameters.

Modelling relationships between stimulation parameters and use thereof for automatic customization of sub-perception therapy in a spinal cord stimulation system

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. Beneficially, sub-perception stimulation at such low frequencies significantly lowers power consumption in the patient's neurostimulator.

Paresthesia-free spinal cord stimulation occurring at lower frequencies and sweet spot searching using paresthesia

Methods and systems for providing electrical stimulation to a patient's spinal cord using electrode leads implanted in the patient's spinal column are described. Embodiments involve cycling between durations during which stimulation is actively applied and durations when no stimulation is applied. The stimulation can be configured such that pain relief washes in during the active stimulation duration and continues for some part of the duration when no stimulation is being applied. Eventually the pain relief may wash out. The washout time may be modeled, so that stimulation may be resumed before the pain relief washes out. The stimulation may be below the patient's perception threshold.

System and method for adaptive neural stimulation

Methods and systems for determining sub-perception stimulation for a patient having a spinal cord stimulator device are disclosed. In one example, an external device includes an algorithm configured to determine a stimulation program for the stimulator device. The algorithm includes a model that comprises pre-determined energy values that cause sub-perception stimulation. The algorithm is configured to determine stimulation parameters for the stimulation program that yield an energy value within the first model. The energy values in the model may be expressed as a function of frequency. The model in particular provides optimal sub-perception stimulation at low frequencies, such as at 1 kHz and below, or even at 400 Hz and below.

Spinal cord stimulation system determining optimal sub-perception therapy by using neural dose

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.

Linking and concurrent steering of multiple pole configurations in a spinal cord stimulation system

Methods and systems for providing electrical stimulation to a patient's spinal cord using electrode leads implanted in the patient's spinal column are described. Embodiments involve biphasic stimulation where during a first phase a first pole provides stimulation to a first location and during a second phase a second pole provides stimulation to a second location. The two phases may have the same or different amplitudes. The amplitudes of the two phases may be determined based on perception thresholds for stimulation at the two locations.

Stimulation targeting and calibration for enhanced surround inhibition recruitment in spinal cord stimulation therapy

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.

Logging the execution of sub-programs within a stimulation program for an implantable stimulator device

Systems and methods are disclosed to permit a patient to use his external controller to move the location of stimulation in an implantable stimulator system. The external controller can be programmed with a steering algorithm, which prompts the patient to enter certain data regarding their symptoms (e.g., pain), such as pain scores and stimulation coverage. Such data is preferably entered for a plurality of different regions of the patient's body. The algorithm can compute for each body regions a targeting precision value (TP), and from these values determine a steering vector D that suggests a direction and/or a magnitude that stimulation can be moved in the electrode array to more precisely target the patient's pain. The patient may then move the location of the stimulation in accordance with the steering vector using their external controller. The algorithm can be repeated if necessary to again move the stimulation.

Precise targeting in a spinal cord stimulation system

A system may include electrodes on at least one lead configured to be operationally positioned for use in modulating a volume of neural tissue, a neural modulation generator configured to deliver energy using at least some electrodes to modulate the volume of neural tissue, a programming system configured to program the programmed modulation parameter set, including determine electrode fractionalizations for the electrodes based on a target multipole. The programmed parameter set may include the determined electrode fractionalizations. The target multipole may be used to determine electrode fractionalizations having at least three target poles that directionally and progressively stack fractionalizations of target poles to provide a linear electric field over the volume of tissue. The neural modulation generator may be configured to use the programmed modulation parameter set to provide the linear electric field over the volume of tissue.

Systems and methods for spatially selective spinal cord stimulation

A fitting algorithm for a spinal cord stimulator is disclosed, which is preferably implemented in a clinician programmer having a graphical user interface. In one example, coupling parameters indicative of coupling to neural structures are determined for each electrode in an implanted electrode array. The user interface associates different pole configurations with different anatomical targets and with different measurement techniques (subjective or objective) to gauge the effectiveness of the pole configuration at different positions in the electrode array. The pole configuration, perhaps as modified by the coupling parameters, is then steered in the array, and effectiveness is measured along with a paresthesia threshold at each position. Using at least this data, the fitting algorithm can determine one or more candidate positions in the electrode array at which a therapeutic stimulation program can be centered.

Fitting algorithm for recruiting of neural targets in a spinal cord stimulator system

An example of a system may include a processor and a memory device comprising instructions, which when executed by the processor, cause the processor to access at least one of: patient input, clinician input, or automatic input, use the patient input, clinician input, or automatic input in a search method. The search method may be designed to evaluate a plurality of candidate neuromodulation parameter sets to identify an optimal neuromodulation parameter set and to program a neuromodulator using the optimal neuromodulation parameter set to stimulate a patient.

Automated program optimization

New waveforms for use in an implantable pulse generator or external trial stimulator are disclosed which mimic actively-driven biphasic pulses, and which are particularly useful for providing sub-perception Spinal Cord Stimulation therapy using low frequency pulses. The waveforms comprise anodic and cathodic pulses which are effectively monophasic in nature, although low-level, non-therapeutic charge recovery can also be used.

Spinal cord stimulation for dorsal column recruitment or suppression using anodic and cathodic pulses

An example of a system to program a neuromodulator to deliver neuromodulation to a neural target using a plurality of electrodes may comprise a programming control circuit configured to determine target energy allocations for the plurality of electrodes based on at least one target pole to provide a target sub-perception modulation field, and normalize the target sub-perception modulation field, including determine a time domain scaling factor to account for at least one property of a neural target or of a neuromodulation waveform, and apply the time domain scaling factor to the target energy allocations.

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West Hills, CA, United States of America

Que T Doan