Advanced Neuromodulation Systems, Inc.

Daran DeShazo

Steven E Boor

Gavin L Rade

Vidhi Desai

Greg Creek

Robert Nobles

Luis Ortiz Hernandez

Edward Lundberg

Nicole R Hughes

Steve Gray

Betty Mark

Pulse pattern detecting circuitry for use with a fractional voltage multiplier of a neurostimulation system is provided. The pulse pattern detecting circuitry is configured to detect an initial overlap of a repeating pulse pattern, wherein the repeating pulse pattern is generated by a plurality of pulse engines that generate pulses at different frequencies, the initial overlap occurring when pulses generated by each of the plurality of pulse engines occur simultaneously, detect a subsequent overlap of the repeating pulse pattern, the subsequent overlap of the pulse pattern occurring when pulses generated by each of the plurality of pulse engines again occur simultaneously, detect a plurality of events between the initial overlap and the subsequent overlap, each event corresponding to at least one of the plurality of pulse engines generating a pulse, and record a voltage multiplier setting for each of the plurality of detected events.

Systems and methods for detecting pulse patterns

A system and method of quantifying, maintaining and managing the functional status and/or therapy settings of an IMD based on code path metrics is disclosed. The codebase of device firmware modules may be instrumented to obtain tracing data and timing metrics data corresponding to different code paths that may be taken when a device subsystem or associated functionality is accessed or activated. Code path metrics of actual code paths may be analyzed to detect a deviation from baseline code path metrics and generate a corresponding graduated response.

Implantable medical device (IMD) with code path metrics

An implantable medical device (IMD) includes multiple stimulation engines (SEs) for independently stimulating respective electrode sets of a lead system. A voltage multiplier (VM) is configured to generate an adjustable target voltage at an output node. Each stimulation engine includes first switching circuitry to switchably connect an anodic node of the SE to the VM output node and second switching circuitry to switchably connect a cathodic node of the SE to a current sink circuit. Discharge switching circuitry may be disposed between the anodic and cathodic nodes of each SE. A selector and associated digital control logic block are operative to generate control signals for independently controlling respective SEs such that each SE may be activated to stimulate or discharge a corresponding select set of electrodes independently from or in concert with remaining SEs.

Neuromodulation therapy with a multiple stimulation engine system

A system and method for operating an implanted medical device (IMD) based on a waveform player. In one arrangement, the IMD may comprise a first module operative to effectuate a communication interface with an external device for receiving a plurality of program records for storage in a persistent memory, the program records each comprising a plurality of pulse definitions and a plurality of time interval definitions, wherein a pulse definition comprises a set of pulse characteristics to be applied in a particular time interval. A second module may be communicatively coupled to the first module, the second module including a buffer for containing a runtime image of a selected program record loaded from the persistent memory. A waveform player provided as part of the second module is operative to interpret the runtime image to generate control signals to drive an output driver circuit for applying pulse characteristics to a select set of electrodes according to the pulse definitions of the selected program record.

System and method for operating an implantable pulse generator for neuromodulation

Embodiments are directed to an implantable medical device comprising therapeutic stimulation circuitry for controlling delivery of a medical therapy to a patient, the therapeutic stimulation circuitry having at least one lead having electrodes for delivering the medical therapy, The implantable medical device further comprises measurement circuitry for determining characteristics of the at least one lead, a processor for controlling the IMD according to executable code, and memory for storing data and executable code, wherein the executable code comprises instructions for causing the processor to receive a plurality of voltage measurements associated with the electrodes, and calculate values for an impedance model of the electrode/tissue interface.

Implantable pulse generator for providing a neurostimulation therapy using complex impedance measurements and methods of operation

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 trained using data corresponding to time intervals in which electrical pulses are applied to the patient, including video kinematic data, patient reported pain levels, implanted or worn sensor patient data, and stimulation parameters. The model is used to control ongoing neurostimulation therapy for the patient.

Systems and methods for providing neurostimulation therapy according to machine learning operations

Embodiments provide methods of conducting operations with an implantable medical device (IMD) and an external controller device for performing authentication operations. In some embodiments, the method comprises: generating or storing an authentication data structure in the external controller device for over-the-air communication between the external device and the IMD, wherein the authentication data structure is generated by: (1) removing attribute fields from a first digital certificate and adding a public key of the external controller device to form an intermediate data structure; (2) creating a digital signature of the first intermediate data structure using a second digital certificate of an issuing certificate authority (CA); and (3) forming the authentication data structure by combining the intermediate data structure, the created digital signature, a public key of the issuing CA, and a digital signature of the public key of the issuing CA created using a third digital certificate of a root CA.

Compressed PKI methods for machine-to-machine authentication in bandwidth-constrained medical devices

A system and method for measuring, monitoring and mitigating EMI interference in an implanted stimulation lead system associated with an IPG. A Kelvin connection scheme operative with a diagnostic circuit is provided for sensing an interference voltage induced at a Kelvin connect electrode of the lead system, wherein the diagnostic circuit is configured to generate one or more control signals for adjusting in substantially real time a common-mode voltage reference provided to supply a biasing voltage to the IPG circuitry.

Diagnostic circuitry for monitoring and mitigating electromagnetic interference (EMI) in an implantable pulse generator

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.

Neuromodulation therapy with custom instruction set architecture for a stimulation engine system

An implantable medical device (IMD) includes one or more stimulation engines (SEs) and selectively connectable output switching circuitry for driving a plurality of output nodes associated with a respective plurality of electrodes of the IMD's lead system when implanted in a patient. The output switching circuitry may be configured to facilitate self-test mode (STM) functionality in the IMD (e.g., when it is in a hermetically sealed package) by using a dual mode switch in series with a stimulation engine selection switch with respect to each output node in the output switching circuitry under mode selection control.

Neurostimulator output switching circuitry with self-test mode

An implantable medical device (IMD) includes multiple stimulation engines for independently stimulating respective electrode sets of a lead system while avoiding collisions and/or channel contention during stimulation delivery. A first voltage multiplier is configured to generate an adjustable target voltage having sufficient headroom at an output node that is commonly coupled to anodic nodes of respective stimulation engines. Each stimulation engine includes a secondary voltage multiplier to drive the respective anode and a current regulator powered by a floating voltage supply, wherein the current regulator is coupled to a cathodic node and configured to control how much stimulation current is pulled from the patient tissue.

Implantable pulse generator with multiple stimulation engines

A neurostimulation (NS) system and method are provided. The NS system includes an array of electrodes positioned within a patient. The array of electrodes includes an active electrode. The active electrode is configured to be a cathode electrode located proximate to neural tissue of interest that is associated with a target region. The NS system includes an anode electrode and an electromagnetic interference (EMI) antenna. A control circuit is configured to control delivery of a NS therapy during a therapy delivery interval. The NS therapy is to be delivered between the anode electrode and the active electrode. The NS system develops a residual voltage between the anode electrode and the active electrode over the therapy delivery interval. A current regulator (CR) circuit is connected to the cathode electrode. The CR circuit is configured to control current flow through the cathode electrodes. During a discharge operation, the control circuit is configured to manage the CR circuit to control a discharge current flow over the discharge operation to discharge the residual voltage after therapy delivery in a manner that follows an actively emulated passive discharge (AEPD) profile. During the discharge operation, the CR circuit is connected to the inactive electrode. The CR circuit receives, as a first input, an EMI feedback signal from the EMI antenna. The CR circuit is configured to regulate the discharge current flow through the active electrode based on the EMI feedback signal, to maintain the AEPD profile over the discharge operation while in a presence of an EMI event.

Neurostimulation method and system for active emulation of passive discharge in presence of MRI/EMI interference

A system and method are provided that include a power supply having positive and negative terminals. The negative terminal defines a reference ground. First and second electrodes are positioned within a patient and configured to be located proximate to tissue of interest that is associated with a target region. A control circuit is configured to control delivery of current for a therapy between the first and second electrodes. A current regulator (CR) circuit is connected to, and configured to control current flow through, at least the first electrode during delivery of the therapy under direction of the control circuit. A floating power supply is connected across power supply terminals of the CR circuit. The CR circuit and floating power supply are coupled to a floating ground node that is electrically separate from the reference ground.

Method and system with current regulator biased by floating power supply

An implantable medical device (IMD) includes an adjustable capacitive voltage multiplier (CVM) that is responsive to diagnostic circuitry configured to provide control signals within a single stimulation current pulse for adjusting the voltage output applied to an electrode of the IMD's lead system. A control counter is coupled to the diagnostic circuitry for incrementing or decrementing an N-bit counter output signal operative to reconfigure a charge pump arrangement of the CVM so as to facilitate an adjusted voltage output.

Capacitive voltage multiplier for providing adjustable control during a stimulation pulse

A system and method for measuring and monitoring charge states of one or more electrodes of an implanted stimulation lead system associated with an IPG. A Kelvin connection scheme operative with a switching circuit is provided for coupling select electrode terminals disposed in a Kelvin connection measurement loop in a switchable manner to sense and reference inputs of an analog-to-digital converter (ADC) configured as at least part of diagnostic circuitry for the IPG.

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Lewisville, TX, United States of America

Daran DeShazo