211 results about "Spinal cord stimulation" patented technology

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.

A system for closed-loop control of sub-perception spinal cord stimulation therapy is provided. The system includes an implantable pulse generator (IPG) with an evoked compound action potential (ECAP) recording module and accelerometer. A regression model maps accelerometer data to optimal stimulation parameters for consistent nerve activation. This enables closed-loop therapy in the sub-perception domain where ECAP features are not visually detectable. A clinician programmer applies the model and sub-perception dose to therapy programs deployed to the IPG. The model can be customized to each patient by collecting ECAP and accelerometer data. The mapping reconciles ECAP -based control between perception and sub-perception domains by supplementing unavailable ECAP data with accelerometer data. This improves stimulation therapies for patients receiving sub-perception and multi-sensor paresthesia treatments.

Methods and systems for spinal cord stimulation (SCS) are disclosed. The methods and systems involve the use of electrode leads implanted within the spine of a patient to record nerve responses induced by a stimulus. The disclosed neural responses differ in various aspects from the electrical responses previously measured in the SCS context, such as stimulation artifacts and evoked compound action potentials (ECAPs). The disclosed neural responses typically occur at a later time after inducing the stimulation pulse. Another significant feature is that when the frequency of evoked stimulation is ultra-low, such as about 10 Hz or less, the disclosed neural response is most significantly observed at a consistent, relatively constant amplitude as a whole. The disclosed methods and systems may use these neural responses as indications of pain, treatment, and / or another clinically relevant dimension to guide / confirm stimulation placement, as well as feedback control for stimulation parameters.

Provided herein are methods of treating a patient comprising providing a medical apparatus comprising an external system and an implantable system, implanting the implantable system, and delivering at least one of power or data to the implantable system with the external system. The external system comprises: at least one external antenna configured to transmit a first transmission signal to the implantable system; an external transmitter configured to drive the at least one external antenna; an external power supply; and an external controller. The implantable system comprises: at least one implantable antenna configured to receive the first transmission signal from the first external device; an implantable receiver; at least one implantable functional element configured to interface with the patient; an implantable controller; an implantable energy storage assembly; and an implantable housing surrounding at least the implantable controller and the implantable receiver. Medical apparatus are also provided.

A system for closed-loop control of sub-perception spinal cord stimulation therapy is provided. The system includes an implantable pulse generator (IPG) with an evoked compound action potential (ECAP) recording module and accelerometer. A regression model maps accelerometer data to optimal stimulation parameters for consistent nerve activation. This enables closed-loop therapy in the sub-perception domain where ECAP features are not visually detectable. A clinician programmer applies the model and sub-perception dose to therapy programs deployed to the IPG. The model can be customized to each patient by collecting ECAP and accelerometer data. The mapping reconciles ECAP-based control between perception and sub-perception domains by supplementing unavailable ECAP data with accelerometer data. This improves stimulation therapies for patients receiving sub-perception and multi-sensor paresthesia treatments.

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 a patient metric of a subject; use the patient metric as an input to a machine learning algorithm, the machine learning algorithm to search a plurality of neuromodulation parameter sets and to identify a candidate neuromodulation parameter set of the plurality of neuromodulation parameter sets, the candidate neuromodulation parameter set designed to produce a non-regular waveform that varies over a time domain and a space domain; and program a neuromodulator using the candidate neuromodulation parameter set to stimulate the subject.

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 a patient metric of a subject; use the patient metric as an input to a machine learning algorithm, the machine learning algorithm to search a plurality of neuromodulation parameter sets and to identify a candidate neuromodulation parameter set of the plurality of neuromodulation parameter sets, the candidate neuromodulation parameter set designed to produce a non-regular waveform that varies over a time domain and a space domain; and program a neuromodulator using the candidate neuromodulation parameter set to stimulate the subject.

Methods and systems for performing spinal cord stimulation in the cervical spine while sensing for an evoked response, such as an evoked synaptic action potential (ESAP) at a different location from the location of stimulation. A first lead may be positioned in the cervical spine for issuing therapy pulses, and sensing is performed at a thoracic or lumbar location, or a caudal cervical location relative to the location of stimulation. First and second leads may be used in a single system, or two separate systems, one for stimulation and another for sensing, may be used.

The invention provides a device and system implanted outside epidural under ultrasonic guidance for temporary electrode stimulation of spinal cord, and the device comprises a risk assessment module which carries out the comprehensive assessment of a patient through a multi-modal risk assessment model, and outputs a risk level or probability; the configuration selection module is used for analyzing the parameter information of the patient according to the parameter information of the patient when the evaluation result is passed, and setting guide configuration requirements; the probe guiding module guides the temporary electrode through an ultrasonic thermodynamic diagram; the effect test module is used for testing electrode functions by using a stimulator and adjusting electrode positions; the fixing and closing module fixes the electrode to avoid displacement; and the recording and monitoring module is used for recording electrode implantation depth, stimulation parameters and patient response. The system can reduce invasiveness and ultrasonic guidance accurate positioning, reduces errors and complications, is easy to popularize and apply, is relatively simple to operate, and is suitable for being popularized and applied in more medical places.

A system may be configured for treating a patient with epileptic seizures. The system may include a therapy delivery system configured to use a set of electrodes positioned adjacent to a spinal cord or dorsal column nuclei and a stimulation configuration to deliver neuromodulation energy to at least one target neural pathway in or near the spinal cord. The at least one target neural pathway includes the dorsal column nuclei or axons projecting to the dorsal column nuclei. The dorsal column nuclei and the axons are somatotopically organized and project to at least one of a cerebellum, a thalamus or a brainstem, which include somatotopically organized nuclei and project axons to different areas of a cortex. The at least one target neural pathway corresponds to at least one of the different areas of the cortex in which the epileptic seizures were located.

An embodiment collects a first set of patient data and a first set of treatment data associated with a patient population treated with spinal cord stimulation. The embodiment clusters the patient population into a plurality of cohorts. The embodiment generates a plurality of states using a second set of patient data associated with a cohort in the plurality of cohorts. The embodiment generates a plurality of actions using a second set of treatment data associated with the cohort. The embodiment determines, based on the plurality of actions, a plurality of probabilities associated with a transition from a first state to a second state in the plurality of states. The embodiment generates, based on the plurality of probabilities, a stimulator action policy for a patient in the cohort.

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 a stimulation location in an electrode array is determined. Preferably, the supra-perception stimulation comprises a bipole formed using actively-driven symmetric biphasic waveforms at active ones of the electrodes in the array. After determining the location, a perception threshold for the bipole at the location is determined and stored, and an amplitude of the stimulation is reduced below the perception threshold to provide a sub-perception stimulation bipole. The determined perception threshold may be used to compose one or more programs using stimulation amplitudes that are a percentage of the determined perception threshold. The one or more programs may run according to schedule. For example, the programs may be interleaved.

Provided in the present application are an arousal electrical stimulation system for rehabilitation of disorders of consciousness and a method. The system comprises: a program control module, used for setting a plurality of stimulation point combinations and a plurality of stimulation parameter combinations; an implanted spinal cord stimulation module, used for sequentially outputting stimulation signals according to the plurality of stimulation point combinations and the plurality of stimulation parameter combinations; an acquisition module, used for acquiring electroencephalographic signals and electromyographic signals when the stimulation signals act on a patient suffering from disorders of consciousness; and a processing module, used for processing the electroencephalographic signals and the electromyographic signals to obtain a human body index, and, on the basis of the human body index, determining an optimal stimulation point combination and an optimal stimulation parameter combination from among the plurality of stimulation point combinations and the plurality of stimulation parameter combinations. The present invention uses the cooperation of in-vitro electroencephalographic and electromyographic sampling devices and a spinal cord electric stimulation device implanted into the human body, and performs calculation by means of the processing module, so as to obtain the optimal electric stimulation electrode point combination and the optimal electric stimulation parameter combination, thereby improving the arousal efficiency.

Systems and methods for controlling autonomic nerve symptoms or side effects via spinal cord stimulation are discussed. An exemplary neuromodulation system includes an electrical stimulator to provide spinal cord stimulation (SCS) to a neural target, a user interface device to receive user input including autonomic nerve symptoms and affected anatomy, and a controller circuit to determine or adjust stimulation parameters based at least on the autonomic nerve symptoms and the affected anatomy. Spinal cord stimulation may be delivered according to the determined or adjusted stimulation parameters to alleviate autonomic symptoms or treat or alleviate autonomic disorders.

A system, device, and method support receiving a data signal from one or more sensors associated with the system in response to therapy delivered to a patient. The system, device, and method support assigning a classification to one or more portions of a waveform associated with the data signal based on characteristic information associated with the one or more portions of the waveform. The system, device, and method support providing, based on the classification, one or more parameters associated with delivering the therapy.

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 a stimulation location in an electrode array is determined. Preferably, the supra-perception stimulation comprises a bipole formed using actively-driven symmetric biphasic waveforms at active ones of the electrodes in the array. After determining the location, a perception threshold for the bipole at the location is determined and stored, and an amplitude of the stimulation is reduced below the perception threshold to provide a sub-perception stimulation bipole. The determined perception threshold may be used to compose one or more programs using stimulation amplitudes that are a percentage of the determined perception threshold. The one or more programs may run according to schedule. For example, the programs may be interleaved.

Algorithms for determining optimal low-frequency and sub-perception spinal cord stimulation for a patient are disclosed. A spread bipole is preferably used both to position the stimulation to target a patient's pain, and to provide the resulting therapy. The stimulation is provided at very low frequencies, such as 10 Hz or less, and preferably 2 Hz. Further, sub-perception is provided by the use of lower amplitudes and at longer pulse widths than are conventional in typical SCS stimulation therapies. This results in determined stimulation therapies which draw very little power. Therapy is preferably provided by the use of symmetric biphasic pulses.

The present technology provides systems and methods for delivering electrical stimulation having relatively long pulse widths to a patient’s spinal cord region to treat autonomic nervous system dysfunction. For example, some embodiments include delivering an electrical therapy signal having individual pulses with pulse widths of between about 2 milliseconds and about 10 seconds. The electrical therapy signals may treat autonomic nervous system dysfunction by normalizing activity of the patient’s parasympathetic nervous system, normalizing activity of the patient’s sympathetic nervous system, and / or normalizing a balance of activity between the patient’s parasympathetic and sympathetic nervous systems.

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 a stimulation location in an electrode array is determined. Preferably, the supra-perception stimulation comprises a bipole formed using actively-driven symmetric biphasic waveforms at active ones of the electrodes in the array. After determining the location, a perception threshold for the bipole at the location is determined and stored, and an amplitude of the stimulation is reduced below the perception threshold to provide a sub-perception stimulation bipole. The determined perception threshold may be transmitted to the patient's remote controller, where it is used to limit amplitude adjustments to the sub-perception bipole by the patient.

Systems, methods, and devices disclosed herein include a transcutaneous spinal cord stimulation (tSCS) system with a stimulation electrode grid. The stimulation electrode grid includes a plurality of anodes and a plurality of cathodes, and the stimulation electrode grid is operable for placement proximate to a spinous process. The system also includes a particularized electrical field generated by selective activation of the stimulation electrode grid. Moreover, a localized tSCS, provided by the particularized electrical field is operable to cause a neuromodulation effect. Also, the stimulation electrode grid includes a substrate material. The plurality of cathodes and the plurality of anodes are both arranged as rows or columns on the substrate material to form an integrated unit. The stimulation electrode grid includes a plurality of selectively activated electrode array activation configurations, and the neuromodulation effect generated by the system can be used to enhance voluntary extremity function and pain management.

A motor function of a subject can be at least partially restored via electrical stimulation. One or more stimulating electrodes can be positioned within a ventral space of a spinal column of the subject to deliver the electrical stimulation to a motor fiber in the spinal column to at least partially restore the motor function. The one or more stimulating electrodes can be in electrical communication with a signal generator. A controller can be connected to the signal generator, and optionally, one or more sensing elements. The controller can receive a signal comprising at least one input, which can be manual or from the one or more sensing elements; configure the electrical signal to stimulate motor fiber(s) in a descending tract of the spinal cord of the subject based on the at least one input; and send the electrical signal to the signal generator to generate the electrical stimulation.

Methods and devices for implanting spinal cord stimulation devices, including thin-film spinal cord stimulation devices and devices for assisting with the implantation of such spinal cord stimulation devices. In some embodiments, the devices and methods include an introduction needle and / or sheath, a stylet, a guide device, and a pushing device for urging a stimulation device into the epidural space by controlling the proximal end of the device, including, in some cases, deformable thin-film spinal cord stimulation devices.

Methods and systems for using sensed neural responses for informing aspects of stimulation therapy are disclosed. For example, features of evoked neural responses, such as evoked compound action potentials (ECAPs) can be used for closed-loop feedback control of stimulation parameters. Aspects of the disclosed methods and systems can differentiate between changes in the sensed neural responses that are caused by the environment at stimulating electrodes and changes in the neural responses that are caused by the environment at sensing electrodes. Embodiments determine changes in the morphology of the neural responses, which morphology changes indicate a degree of change in the stimulating environment. Algorithms and systems for assigning and tracking likelihoods for underlying electrode-tissue changes based on sensed neural responses are disclosed. The feedback control modality may be updated based on such likelihoods. Also disclosed are methods and systems for determining which features of evoked neural responses are more sensitive to changes in the stimulating environment and less sensitive to changes in the sensing environment.

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.

Systems and methods for controlling autonomic symptoms or side effects via spinal cord stimulation are discussed. An exemplary neuromodulation system comprises an electrostimulator to provide spinal cord stimulation (SCS) to a neural target, a user interface device to receive a user input including an autonomic symptom and affected anatomy, and a controller circuit to determine or adjust a stimulation parameter based at least on the autonomic symptoms and the affected anatomy. Spinal cord stimulation can be delivered in accordance with the determined or adjusted stimulation parameter to alleviate the autonomic symptom, or to treat or alleviate autonomic disorders.

Methods and devices for implanting spinal cord stimulation devices, including thin-film spinal cord stimulation devices and devices for assisting with the implantation of such spinal cord stimulation devices. In some embodiments, the devices and methods include an introduction needle and / or sheath, a stylet, a guide device, and a pushing device for urging a stimulation device into the epidural space by controlling the proximal end of the device, including, in some cases, deformable thin-film spinal cord stimulation devices.

The invention discloses an electrical stimulation physiotherapy device based on multi-mode multi-point stimulation, and the device comprises a control module which is used for determining a physiotherapy mode corresponding to a user, and outputting a control instruction according to the physiotherapy mode; and the at least two electrode modules are connected to the control module, are arranged in a cortex stimulation area and a spinal cord stimulation area of the user, and are used for synchronously outputting current to a plurality of stimulation target spots of the cortex stimulation area and the spinal cord stimulation area according to the control instruction so as to realize collaborative physiotherapy. Therefore, the multiple electrode modules arranged in the cortex area and the spinal cord area can be controlled according to different physiotherapy modes based on the control module, so that multi-mode and multi-target synchronous synergistic electrical stimulation physiotherapy is realized, and the intelligent degree and the treatment effect of the overall electrical stimulation physiotherapy are improved.

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.

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.

This present disclosure provides systems and methods relating to neuromodulation. In particular, the present disclosure provides systems and methods for identifying optimized temporal patterns of spinal cord simulation (SCS) for minimizing variability in patient responses to SCS. The systems and methods of neuromodulation disclosed herein facilitate the treatment of neuropathic pain associated with various disease states and clinical indications.