Boston Scientific Neuromodulation Corporation

Duke University

Tianhe Zhang

Rosana Esteller

Que T Doan

Michael A Moffitt

Warren M Grill

Stephen Carcieri

G Karl Steinke

Richard Mustakos

Natalie A Brill

Changfang Zhu

Deepa Mahajan

Bradley Lawrence Hershey

Mahsa Malekmohammadi

Andrew James Haddock

Bhaskar Sen

Matthew Lee McDonald

Kiran K Gururaj

Jessica Block

Pranjali Borkar

Jordi Parramon

Qi An

Rafael Carbunaru

Joseph M Bocek

Jianwen Gu

Thomas W Stouffer

Gezheng Wen

Venugopal Allavatam

An example of a system for delivering neurostimulation and sensing one or more signals may include a programming control circuit and a parameter control circuit. The programming control circuit may be configured to control the delivery of the neurostimulation according to stimulation parameters and the sensing of a target neural signal including target neural responses according to sensing parameters. The parameter control circuit may be configured to determine the stimulation parameters and the sensing parameters and may include a recording analyzer. The recording analyzer may be configured to evaluate a sequence of test recording configurations each including a set of recording configuration parameters selected from the stimulation parameters and the sensing parameters and to determine one or more recording configurations suitable for detection of the target neural responses using an outcome of the evaluation.

Method and apparatus for optimizing neural sensing

Systems and methods for closed-loop control of electrostimulation while avoiding, or maintaining a substantially low level of, evoked neural activity are disclosed. A system comprises an electrostimulator to deliver a stimulation pulse train, a sensing circuit to sense evoked responses to respective pulses in the pulse train, and a controller to detect an evoked neural activity from an averaged evoked response by averaging evoked responses to respective pulses. The averaging operation can be controlled by a noise level of the averaged evoked response, or by a count of epochs (pulses) being used for averaging. Responsive to the evoked neural activity satisfying a detection criterion, the controller recursively adjusts stimulation parameters until the detection criterion is no longer satisfied. The electrostimulator delivers electrostimulation according to the recursively adjusted stimulation parameters.

Closed loop stimulation based on response avoidance

A method for estimating neural activation arising from stimulation by a stimulation system includes identifying different neural elements stimulated by the stimulation; obtaining a neural response signal resulting from the stimulation by the stimulation system; and decomposing the neural response signal to estimate neural activation of each of the different neural elements.

Methods and systems for estimating neural activation by stimulation using a stimulation system

An example of a neurostimulation system may include a storage device for storing data representing physiological signals and a user interface including a user input, a display screen, and a presentation control circuit. The user input may be configured to receive a selection of signal(s) from the physiological signals and a selection of viewing mode from viewing modes including a metric mode and/or a presence mode. The metric mode allows for visualization of a signal property indicated by a parameter measured from the selected signal(s). The presence mode allows for viewing presence of a feature in the selected signal(s). The presentation control circuit may be configured to allow for the selection of the signal(s) and the viewing mode, to determine a segment of each of the selected signal(s) for presentation according to the selected viewing mode, and to present the determined segment on the display screen.

User interface for neural signal and biomarker visualization and assessment

Methods and systems for programming stimulation parameters for an implantable medical device for neuromodulation, such as spinal cord stimulation (SCS) are disclosed. The stimulation parameters define user-configured waveforms having at least a first phase having a first polarity and a second phase having a second polarity, wherein the first and second phases are separated by an interphase interval (IPI). By delivering user-configured waveforms with different IPIs, stimulation geometry, and other waveform settings, therapeutic asynchronous activation of dorsal column fibers can be obtained.

Stimulation configuration variation to control evoked temporal patterns

A neuromodulation targeting system includes a GUI that facilitates selection of one or more neuromodulation target regions. The GUI provides an interactive display representing anatomy of a patient with user-selectable portions corresponding to a plurality of predefined anatomical regions associated with distinct localized clinical effects of neuromodulation. The system further includes a targeting selector engine that is responsive to user selection of a first portion of the interactive display by configuring delivery of neuromodulation therapy to a first target region to produce a first localized clinical effect in the patient at a location corresponding to the first portion of the display, upon administration of the neuromodulation therapy to the patient.

Anatomical targeting of neuromodulation

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

Methods and systems are described for detecting if a stimulation lead implanted in a patient's brain has moved. Lead movement occurring between a first time and a second time may be determined by comparing features extracted from evoked potentials recorded at the two times. The disclosed methods and systems are particularly useful for determining if a stimulation lead has moved between the time it was implanted in the patient's brain and the time that stimulation parameters are being optimized. Lead movement during implantation, during parameter optimization, and during or between other lead optimization processes may be determined as well.

Methods and systems for target localization and DBS therapy

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

Systems and methods for optimizing neuromodulation field design for pain therapy are discussed. An exemplary neuromodulation system includes an electrostimulator to stimulate target tissue to induce paresthesia, a data receiver to receive pain data including pain sites experiencing pain, and to receive patient feedback on the induced paresthesia including paresthesia sites experiencing paresthesia. The neuromodulation system includes a processor circuit configured to generate a spatial correspondence indication between the pain sites and the paresthesia sites over one or more dermatomes, determine an anodic weight and a cathodic weight for each of multiple electrode locations using the spatial correspondence indication, and generate a stimulation field definition for neuromodulation pain therapy.

Targeted electrostimulation fields based on focal dermatomal coverage

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 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.

Method and apparatus for clinical effects-based targeting of neurostimulation

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.

Sub-perception calibration using time domain scaling

A sensing electrode selection algorithm is disclosed for use with an implantable pulse generator having an electrode array. The algorithm automatically selects optimal sensing electrodes in the array to be used with a pre-determined stimulation therapy appropriate for the patient. The algorithm preferably senses stimulation artifacts using different sensing electrodes, and more specifically different sensing electrode pairs as is appropriate when differential sensing is used. The algorithm further preferably senses these stimulation artifacts with the patient placed in two or more postures. The algorithm processes the stimulation artifact features measured at the different sensing electrodes and at the different postures to automatically determine one or more sensing electrode pairs that best distinguishes the two or more postures given the prescribed stimulation therapy.

Selection of sensing electrodes in a spinal cord stimulator system using sensed stimulation artifacts

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.

Growing community of inventors

Studio City, CA, United States of America

Tianhe Zhang