The present disclosure provides systems and methods for providing neurostimulation therapy according to patient features. The patient features may be analyzed to develop a patient model between physiological and/or patient reported features and optimal settings for a neurostimulation therapy using machine learning operations. The model is used to control ongoing neurostimulation therapy for the patient.

A computer brain interface (CBI) device of an individual applies a burst sequence of stimulation pulses to afferent sensory nerve fibers to elicit a bioelectric response via a neurostimulation interface operably connected to or integrated with the CBI device. The neurostimulation interface senses the bioelectric responses of the stimulated afferent sensory nerve fibers. The CBI device derives, based on the sensed bioelectric responses, a neural excitability profile characterizing a non-linear, dynamic excitation behavior of the afferent sensory neurons corresponding to the applied sequence of stimulation pulses. At least one stimulation parameter of the current set of stimulation parameters is adjusted based on the derived excitability profile to obtain an updated set of stimulation parameters.

An implanted medical device is prepared for a magnetic resonance imaging (MRI) scan by being programmed into an MRI mode when deemed appropriate by an external device implementing an MRI mode control application. An MRI technologist or other user may use the external device to screen the patient and implanted medical device for the MRI scan and enable the MRI mode at the implanted medical device when it is deemed appropriate in the MRI mode control application. Therapy parameters for the MRI mode may be determined on the basis of information about the device and patient, and those therapy parameters may be programmed into the implanted medical device upon enabling the MRI mode. The MRI technologist or other user may use the external device to disable the MRI mode and return to normal operation once the MRI scan is complete.

The present invention provides improved methods for positioning of an implantable lead in a patient with an integrated EMG and stimulation clinician programmer. The integrated clinician programmer is coupled to the implantable lead, wherein the implantable lead comprises at least four electrodes, and to at least one EMG sensing electrode minimally invasively positioned on a skin surface or within the patient. The method comprises delivering a test stimulation at a stimulation amplitude level from the integrated clinician programmer to a nerve tissue of the patient with a principal electrode of the implantable lead. Test stimulations are delivered at a same stimulation amplitude level for a same period of time sequentially to each of the four electrodes of the implantable lead. A stimulation-induced EMG motor response is recorded with the integrated clinician programmer for each test stimulation on each electrode of the implantable lead via the at least one pair of EMG sensing electrodes so as to facilitate initial positioning of the implantable lead at a target stimulation region.

Methods and apparatuses for stimulation of the vagus nerve to treat inflammation including adjusting the stimulation based on one or more metric sensitive to patient response. The one or more metrics may include heart rate variability, level of T regulatory cells, particularly memory T regulatory cells, temperature, etc. Stimulation may be provided through an implantable microstimulator.

An example of a system for programming neurostimulation according to a stimulation configuration may include stimulation configuration circuitry, volume definition circuitry, stimulation effect circuitry, and recording circuitry. The stimulation configuration circuitry may be configured to determine the stimulation configuration. The volume definition circuitry may be configured to determine stimulation field model(s) (SFM(s)) each representing a volume of tissue activated by the neurostimulation. The stimulation effect circuitry may be configured to determine a stimulation effect type for each tagging point specified for the SFM(s) and to tag the SFM(s) at each tagging point with the stimulation effect type determined for that tagging point. The stimulation effect type for each tagging point is a type of stimulation resulting from the neurostimulation as measured at that tagging point. The recording circuitry may be configured to generate SFM data representing the determined SFM(s) with the stimulation effect type tagged at each tagging point.

An apparatus includes a flexible, electrically conducting layer disposed between a first flexible electrically insulating layer and a second flexible electrically insulating layer. At least one of the first electrically insulating layer, the electrically conducting layer, or the second electrically insulating layer includes multiple recesses defined therein, the recesses collectively having a predefined pattern. The apparatus also includes protrusions in the form of penetrating beam structures capable of accessing deep tissue structures, and at least one electrical access site electrically coupled to the electrically conducting layer, forming an electrode site. The apparatus also includes microelectronic circuitry/coils and components to serve as an implantable, flexible, conformally adjustable, interface for stimulating and/or recording electrical activity in biological tissue.

An implantable medical device (IMD) configured to provide stimulation therapy using an instruction set architecture (ISA) includes a main processor operating at a first frequency and a secondary processor operating at a second frequency lower than the first frequency. Example ISA may comprise assembly-language-like instructions that may be executed by the secondary processor for configuring one or more stimulation engines (SEs) to cause stimulation of select electrode sets of a lead system based on one or more pulse definitions and one or more timing definitions corresponding to a therapy program selection effectuated by a user at an external device.

The present method and system provides for the clinical application of neurostimulation and/or neuromodulation to a patient. The method and system includes receipt and acquisition of patient data, processing of that data relative to one or more known data sets, and determination of a good-fit trigger specific treatment protocol. The method and system provides for application of the protocol to the patient, including delivery of neuromodulation and biofeedback. Based thereon, the method and system re-iterates the goodness of fit determination for further treatment to the patient.

A method for subcutaneously treating pain in a patient includes first providing a neurostimulator with an IPG body and at least a primary, a secondary, and a tertiary integral lead with electrodes disposed thereon. A primary incision is opened to expose the subcutaneous region below the dermis in a selected portion of the body. A pocket is then opened for the IPG through the primary incision and the integral leads are inserted through the primary incision and routed subcutaneously to desired nerve regions along desired paths. The IPG is disposed in the pocket through the primary incision. The primary incision is then closed and the IPG and the electrodes activated to provide localized stimulation to the desired nerve regions and at least three of the nerves associated therewith to achieve a desired pain reduction response from the patient.