Boston Scientific Neuromodulation Corporation

Advanced Bionics Corporation

Goran Nils Marnfeldt

Jordi Parramon

Emanuel Feldman

Pujitha Weerakoon

Philip Leonard Weiss

Rafael Carbunaru

David Michael Wagenbach

Jess Weiqian Shi

Paul James Griffith

Kelly Hobart McClure

Matthew Isaac Haller

Kiran K Gururaj

Rudolph V Park

Daniel J Klosterman

Michael A Moffitt

Christopher Britton Gould

Robert R Tong

Adam Thomas Featherstone

Kenneth Hermann

Todd K Whitehurst

Rosana Esteller

Tom Xiaohai He

Robert Dai Ozawa

James R Thacker

James P McGivern

G Karl Steinke

Yuping He

Natalie A Brill

Dave Peterson

Kelly H Mcclure

Changfang Zhu

Sridhar Kothandaraman

Daniel Aghassian

Kristen N Jaax

Bradley Lawrence Hershey

Stephen Carcieri

James Carl Makous

Chirag Shah

Kiran Nimmagadda

Salomo Siilas Murtonen

Meredith Lee Anderson

John Rivera

Peter K Johnson

Mary Kotchevar

A Graphical User Interface (GUI) for an external device used to program an implantable stimulator device is disclosed. The GUI includes aspects useful in adjusting the current magnitude provided at one or more of the stimulator device's electrodes. In particular, the GUI includes an amplitude slider, which allows the user to slide an indicator to increase or decrease the current magnitude at different rates depending on the length of the slide. The GUI further allows the user to prescribe drop back functionality, which reduces the current magnitude by a prescribed amount when the indicator is released. In one example, drop back functionality can be engaged in accordance with a rate threshold, and thus drop back functionality will only occur when the rate of increase equals or is above the threshold when the control button is released.

Graphical user interface for adjusting current magnitude in a stimulator device

Passive tissue biasing circuitry in an Implantable Pulse Generator (IPG) is disclosed to facilitate the sensing of neural responses by holding the voltage of the tissue to a common mode voltage (Vcm). The IPG's conductive case electrode, or any other electrode, is passively biased to Vcm using a capacitor, as opposed to actively driving the (case) electrode to a prescribed voltage using a voltage source. Once Vcm is established, voltages accompanying the production of stimulation pulses will be referenced to Vcm, which eases neural response sensing. An amplifier can be used to set a virtual reference voltage and to limit the amount of current that flows to the case during the production of Vcm. In other examples, circuitry can be used to monitor the virtual reference voltage as useful to enabling the sensing the neural responses, and as useful to setting a compliance voltage for the current generation circuitry.

Circuitry to assist with neural sensing in an implantable stimulator device

A compliance voltage management algorithm is disclosed for managing the compliance voltage, VH, that powers the DAC circuitry in a stimulator device. A user can use a user interface associated with an external programming device to define a time-varying stimulation waveform to be programmed into the stimulator device. The algorithm analyzes the prescribed waveform and determines a number of groups of pulses that will be treated similarly from a VH management standpoint. Optimal compliance voltages are determined for each group, as are the rise and fall rates at which VH is able to change at transitions between groups. These rise or fall rates in VH are then used to set when the compliance voltage should increase or decrease. For example, the algorithm will automatically set VH to start rising in advance of a transition so that it is at the proper higher value when the transition occurs.

Management of compliance voltage for a stimulator device

Sense amplifier (amp) circuitry for an implantable stimulator device is disclosed useful for sensing neural responses or other voltages in a patient's tissue. The sense amp circuitry comprises a low-voltage and a high-voltage sense amp circuit, either of which may be selected based on an assessment of the magnitude of the voltage at either or both of the inputs connected to selected sensing electrodes. The assessed magnitude, as determined by monitoring circuitry, can be processed by an algorithm to select use of one of the sense amp circuits, selecting the low-voltage sense amp circuit when the magnitude(s) are lower, and the high-voltage sense amp circuit when the magnitude(s) are higher. Furthermore, DC offset compensation circuitry is disclosed to equate the DC levels of the inputs, which may only operate when the high-voltage sense amp is selected.

Circuitry to assist with neural sensing in an implantable stimulator device in the presence of stimulation artifacts

Improved stimulation circuitry for controlling the stimulation delivered by an implantable stimulator is disclosed. The stimulation circuitry includes memory circuitry that stores pulse programs that define pulse shapes, steering programs that define electrode configurations, and aggregate programs that link a selected pulse program with a selected steering program. Each steering program defines the stimulation polarity and the allocation of current of the specified stimulation polarity for each of the pulse generator's electrodes. Each pulse program includes one or more pulse instructions, where each instruction defines the parameters of a single phase of the pulse program. Pulse definition circuits in the stimulation circuitry execute aggregate programs to generate stimulation waveforms, which stimulation waveforms can be generated simultaneously by the different pulse definition circuits.

Pulse definition circuitry for creating stimulation waveforms in an implantable pulse generator

Regulator circuitry for producing a regulated output voltage in an implantable stimulation device and associated methods are disclosed. The regulator circuitry is particularly useful where a load current drawn from the output voltage involves transients, such as occurs when the output voltage is used to power a charge pump that creates a higher power supply voltage (e.g., a compliance voltage) in the device. The output current is sampled and downscaled in the regulator, and is further mirrored and filtered. This filtered current provides a control voltage in which transients are minimized and smoothed, and which is more suitable for use as a feedback voltage when producing the output voltage.

Voltage regulator for providing a stable output voltage in an implantable stimulator device

The problem of a potentially high amount of supra-threshold charge passing through the patient's tissue at the end of an Implantable Pulse Generator (IPG) program is addressed by circuitry that periodically dissipates only small amount of the charge stored on capacitances (e.g., DC-blocking capacitors) during a pulsed post-program recovery period. This occurs by periodically activating control signals to turn on passive recovery switches to form a series of discharge pulses each dissipating a sub-threshold amount of charge. Such periodic pulsed dissipation may extend the duration of post-program recovery, but is not likely to be noticeable by the patient when the programming in the IPG changes from a first to a second program. Periodic pulsed dissipation of charge may also be used during a program, such as between stimulation pulses.

Pulsed passive charge recovery circuitry for an implantable medical device

Digital-to-Analog (DAC) circuitry for an implantable pulse generator is disclosed which is used to program currents at the electrodes. Calibration circuitry allows the positive and negative currents produced at each electrode to be independently calibrated to achieve an ideal (linear) response across a range of amplitude values provided to the DAC circuitry by a digital amplitude bus. The calibration circuitry includes electrode gain and electrode offset circuitry for each of the electrodes. Current range DAC circuitry is also provided which can be used to adjust the gain and offset current at all of the electrodes. The current range DAC circuitry is particularly useful when spanning a range of therapeutic currents for a patient, and allows all possible amplitude values provided by the digital bus to be used to span the range. This can improve (reduce) the current resolution of the electrode currents with each amplitude value step.

Current generation architecture for an implantable stimulator device

A new architecture is disclosed for an IPG having a master and slave electrode driver integrated circuits (ICs). The electrode outputs on the ICs are wired together. Each IC can be programmed to provide pulses with different frequencies. Active timing channels in master and slave ICs are programmed to provide the desired pulses, while shadow timing channels in the master and slave are programmed with the timing data from the active timing channels in the other IC so that each chip knows when the other is providing a pulse, so that each chip can disable its recovery circuitry so as not to defeat those pulses. In the event of pulse overlap at a given electrode, the currents provided by each chip will add at the affected electrode. Compliance voltage generation is dictated by an algorithm to find an optimal compliance voltage even during periods when pulses are overlapping.

Architectures for an implantable stimulator device having a plurality of electrode driver integrated circuits with shorted electrode outputs

Recovery circuitry for passively recovering charge from capacitances at electrodes in an Implantable Pulse Generator (IPG) is disclosed. The passive recovery circuitry includes passive recovery switches intervening between each electrode node and a common reference voltage, and each switch is in series with a variable resistance that may be selected based on differing use models of the IPG. The passive recovery switches may also be controlled in different modes. For example, in a first mode, the only recovery switches closed after a stimulation pulse are those associated with electrodes used to provide stimulation. In a second mode, all recovery switches are closed after a stimulation pulse, regardless of the electrodes used to provide stimulation. In a third mode, all recovery switches are closed continuously, which can provide protection when the IPG is in certain environments (e.g., MRI), and which can also be used during stimulation therapy itself.

Passive charge recovery circuitry for an implantable medical device

This document discusses, among other things, systems and methods for programming neuromodulation therapy to treat neurological or cardiovascular diseases. A system includes an input circuit that receives a modulation magnitude representing a level of stimulation intensity, a memory that stores a plurality of gain functions associated with a plurality of modulation parameters, and a electrostimulator that may generate and deliver an electrostimulation therapy. A controller may program the electrostimulator with the plurality of modulation parameters based on the received modulation magnitude and the plurality of gain functions, and control the electrostimulator to generate electrostimulation therapy according to the plurality of modulation parameters.

Systems and methods for programming neuromodulation waveform

The disclosed techniques allow for externalizing errors from an implantable medical device using the device's charging coil, for receipt at an external charger or other external device. Transmission of errors in this manner is particularly useful when telemetry of error codes through a traditional telemetry coil in the implant is not possible, for example, because the error experienced is so fundamental as to preclude use of such traditional means. By externalizing the error via the charging coil, and though the use of robust error modulation circuitry in the implant designed to be generally insensitive to fundamental errors, the external charger can be consulted to understand the failure mode involved, and to take appropriate action.

Signaling error conditions in an implantable medical device system using simple charging coil telemetry

Sense amplifier circuits particularly useful in sensing neural responses in an Implantable Pulse Generator (IPG) are disclosed. The IPG includes a plurality of electrodes, with one selected as a sensing electrode and another selected as a reference to differentially sense the neural response in a manner that subtracts a common mode voltage (e.g., stimulation artifact) from the measurement. The circuits include a differential amplifier which receives the selected electrodes at its inputs, and comparator circuitries to assess each differential amplifier input to determine whether it is of a magnitude that is consistent with the differential amplifier's input requirements. Based on these determinations, an enable signal is generated which informs whether the output of the differential amplifier validly provides the neural response at any point in time. Further, clamping circuits are connected to the differential amplifier inputs to clamp these inputs in magnitude to prevent the differential amplifier from damage.

An architecture is disclosed for an Implantable Pulse Generator having improved compliance voltage monitoring and adjustment software and hardware. Software specifies which stimulation pulses are to be measured as relevant to monitoring and adjusting the compliance voltage. Preferably, specifying such pulses occurs by setting a compliance monitoring instruction (e.g., a bit) in the program that defines the pulse, and the compliance monitor bit instruction may be set at a memory location defining a particular pulse phase during which the compliance voltage should be monitored. When a compliance monitor instruction issues, the active electrode node voltages are monitored and compared to desired ranges to determine whether they are high or low. Compliance logic operates on these high/low signals and processes them to decide whether to issue a compliance voltage interrupt to the microcontroller, which can then command the compliance voltage generator to increase or decrease the compliance voltage.

Compliance voltage monitoring and adjustment in an implantable medical device

An Implantable Pulse Generator (IPG) or External Trial Stimulator (ETS) system is disclosed that is capable of sensing an Evoked Compound Action Potential (ECAP), and (perhaps in conjunction with an external device) is capable of adjusting a stimulation program while keeping a location of a Central Point of Stimulation (CPS) constant. Specifically, one or more features of measured ECAP(s) indicative of its shape and size are determined, and compared to thresholds or ranges to modify the electrode configuration of the stimulation program.

Adjustment of stimulation in a stimulator using detected evoked compound action potentials

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Valencia, CA, United States of America

Goran Nils Marnfeldt