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EP-4739382-A1 - METHOD FOR ARBITRATION BETWEEN PULSES IN A NEUROSTIMULATION DEVICE

EP4739382A1EP 4739382 A1EP4739382 A1EP 4739382A1EP-4739382-A1

Abstract

Methods and devices for controlling arbitration in an implantable medical device capable of issuing therapy stimulus for a plurality of therapy programs. The system defines a therapy program at multiple levels including pulse programs, aggregate instructions, and therapy programs. Holdoff and/or arbitration settings are available at several levels of the therapy program definition, allowing increased flexibility and control.

Inventors

  • WEISS, PHILIP LEONARD

Assignees

  • Boston Scientific Neuromodulation Corporation

Dates

Publication Date
20260513
Application Date
20240813

Claims (15)

  1. 1. An implantable medical device comprising: a housing (10) containing a power source (32), a controller (30, 130), and stimulation circuitry (34, 150); and a lead (20) having a plurality of electrodes (22) thereon, the lead coupled to the housing such that the stimulation circuitry can issue stimulus pulse patterns to a patient via the electrodes; wherein the controller comprises: a memory (100) including steering memory (102), aggregate memory (104), pulse memory (106), and configuration memory (108); a plurality of pulse definition circuits (110, 120, 122, 124) each including steering logic (112), aggregate logic (114), and pulse logic (116); wherein the steering memory contains steering instruction sets for a plurality of steering programs, each steering program determining which of the electrodes receive a fraction of a total stimulus output, and the steering logic is configured to implement a selected steering instruction set; wherein the pulse memory contains pulse programs, each having a one or more pulse instructions defining pulse components each having a pulse type and one or more determining characteristics for the pulse type; wherein the aggregate memory contains aggregate instructions each defining one or more aggregated outputs, each aggregated output pairing a selected steering instruction set with a selected pulse program and defining a number of repetitions for the selected pulse program to execute with the selected steering instruction set; wherein the configuration memory contains a plurality of therapy configuration instruction sets each having a defined total stimulus output amplitude, an arbitration mode, a holdoff setting, and identifying a one or more aggregate instructions to be executed for each therapy configuration; further wherein the arbitration mode defined in the configuration memory for each therapy configuration instruction set determines whether the therapy configuration instruction sets will wait for completion of portions of other therapy configuration instruction sets before initiating, and the holdoff setting determines whether the therapy configuration instruction set can be interrupted by another therapy configuration instruction set; and wherein the controller is configured to execute the plurality of therapy configurations to generate output pulses using the stimulation circuity by: initiating execution of a first therapy configuration instruction set; while executing the first therapy configuration instruction set, receiving a request to execute a second therapy configuration instruction set; determining whether the arbitration mode for the second therapy configuration instruction set allows the second therapy configuration instruction set to wait for completion of portions of other therapy configuration instruction sets and, if not, initiating execution of the second therapy configuration instruction set while the first therapy configuration instruction set is executing, or else: determining whether the holdoff setting for the first therapy configuration instruction set allows interruption of the first therapy configuration instruction set by the second therapy configuration instruction set and: if so, completing an ongoing execution of at least a portion of the first therapy configuration instruction set, and then starting execution of the second therapy configuration instruction set; or if not, completing execution of the first therapy configuration instruction set before allowing the second therapy configuration instruction set to be started.
  2. 2. The implantable medical device of claim 1, wherein, if the holdoff setting for the first therapy configuration instruction set allows interruption of the first therapy configuration instruction set by the second therapy configuration instruction set, the controller is configured, while the second therapy configuration instruction set is being executed, to determine whether the holdoff setting of the second therapy configuration instruction set allows interruption of the second therapy configuration instruction set and, if so, interrupting the second therapy configuration instruction set after completing execution of a portion thereof to execute a portion of the first therapy configuration instruction set.
  3. 3. The implantable medical device of claim 1 , wherein, if the holdoff settings of the first and second therapy configuration instruction sets allow interruption of each of the first and second therapy configuration instruction sets, the controller is configured to alternate between execution of a portion of the first therapy configuration instruction set and execution of a portion of the second therapy configuration instruction set until completion of all aggregate instruction of one of the first and second therapy configuration instruction sets.
  4. 4. The implantable medical device of any of claims 1-3 wherein: each aggregate instruction includes an aggregate holdoff setting, and the controller is configured to determine, using aggregate holdoff settings of the aggregate instructions, the portion the first configuration instruction set to execute before switching to execute a portion of the second therapy configuration instruction set.
  5. 5. The implantable medical device of any of claims 1-4 wherein: each pulse component includes a pulse component holdoff setting, and the controller is configured to determine, using pulse component holdoff settings of the pulse components, the portion the first therapy configuration instruction set to execute before switching to execute a portion of the second therapy configuration instruction set.
  6. 6. An implantable medical device comprising: a housing (10) containing a power source (32), a controller (30, 130), and stimulation circuitry (34, 150); and a lead (20) having a plurality of electrodes (22) thereon, the lead coupled to the housing such that the stimulation circuitry can issue stimulus pulse patterns to a patient via the electrodes; wherein the controller comprises: a memory (100) including steering memory (102), aggregate memory (104), pulse memory (106), and configuration memory (108); a plurality of pulse definition circuits (110, 120, 122, 124) each including steering logic (112), aggregate logic (114), and pulse logic (116); wherein the steering memory contains steering instruction sets for a plurality of steering programs, each steering program determining which of the electrodes receive a fraction of a total stimulus output amplitude, and the steering logic is configured to implement a selected steering instruction set; wherein the pulse memory contains pulse programs, each having a one or more pulse instructions defining pulse components each having a pulse type and one or more determining characteristics for the pulse type; wherein the aggregate memory contains aggregate instructions for a plurality of aggregated outputs, each pairing a selected steering instruction set with a selected pulse program and defining a number of repetitions, each aggregate instruction including an aggregate holdoff setting, further wherein the aggregate holdoff setting for each aggregate instruction determines whether the aggregate instruction can be interrupted by another therapy configuration; and wherein the configuration memory defines a plurality of therapy configuration instruction sets each having a defined total stimulus output amplitude, and identifying a set of aggregate instructions to be executed for each therapy configuration instruction set; wherein the controller is configured to execute the plurality of therapy configuration instruction sets to generate output pulses using the stimulation circuity in accordance with instructions from the therapy configuration instruction sets by: initiating execution of a first therapy configuration instruction set; while executing the first therapy configuration instruction set, determining a second therapy configuration instruction set is to be executed; (x) determining whether the aggregate holdoff setting for an ongoing aggregate instruction being executed allows interruption of the ongoing aggregate instruction by the second therapy configuration instruction set and: if so, completing execution of a pulse program of the ongoing aggregate instruction set of the first therapy configuration instruction set and then starting execution of at least a first aggregate instruction set of the second therapy configuration instruction set; or if not, completing execution of the ongoing aggregate instruction set of the first therapy configuration instruction set and then initiating execution of at least the first aggregate instruction of the second therapy configuration to be executed.
  7. 7. The implantable device of claim 6, wherein: each pulse component includes a pulse component holdoff setting, and the controller is configured to determine, using pulse component holdoff settings of the pulse components, the portion the first therapy configuration instruction set to execute before switching to execute a portion of the second therapy configuration instruction set.
  8. 8. An implantable medical device comprising: a housing (10) containing a power source (32), a controller (30, 130), and stimulation circuitry (34, 150); and a lead (20) having a plurality of electrodes (22) thereon, the lead coupled to the housing such that the stimulation circuitry can issue stimulus pulse patterns to a patient via the electrodes; wherein the controller comprises: a memory (100) including steering memory (102), aggregate memory (104), pulse memory (106), and configuration memory (108); a plurality of pulse definition circuits (110, 120, 122, 124) each including steering logic (112), aggregate logic (114), and pulse logic (116); wherein the steering memory contains steering instruction sets for a plurality of steering programs, each steering program determining which of the electrodes receive a fraction of a total stimulus output amplitude, and the steering logic is configured to implement a selected steering instruction set; wherein the pulse memory contains pulse programs, each having a one or more pulse instructions defining pulse components each having a pulse type and one or more determining characteristics for the pulse type, each pulse instruction including a pulse holdoff setting; wherein the aggregate memory contains aggregate instruction sets for a plurality of aggregated outputs, each pairing a selected steering instruction set with a selected pulse program and defining a number of repetitions; wherein the configuration memory defines a plurality of therapy configurations each having a defined total stimulus output amplitude and identifying a set of aggregate instructions to be executed for each therapy configuration; further wherein the pulse holdoff setting of each pulse instruction determines whether the pulse instruction allows concurrent execution of another therapy configuration during execution of the pulse instruction; and wherein the controller is configured to execute the plurality of therapy configurations to generate output pulses using the stimulation circuity in accordance with instructions from the therapy configurations by: initiating execution of a first therapy configuration; while executing the first therapy configuration, receiving a request to start a second therapy configuration; in response to the request to start the second therapy configuration, checking a pulse holdoff setting for a next pulse instruction to be executed in the pulse program and: if the pulse holdoff setting of the next pulse instruction allows concurrent therapy by another therapy configuration, starting the second therapy configuration when starting execution of the next pulse instruction; or else waiting at least until completion of execution of the next pulse instruction before starting execution of the second therapy configuration.
  9. 9. The implantable medical device as in claim 8, wherein, in response to the request to start the second therapy configuration, the controller is configured to prevent initiation of the second therapy configuration until either: a subsequent pulse instruction has a holdoff setting allowing concurrent therapy by another therapy configuration; or the controller completes execution of at least the pulse program that is executing at the time the request to start the second therapy configuration is received.
  10. 10. The implantable medical device as in claim 8, wherein, in response to the request to start the second therapy configuration, the controller is configured to prevent initiation of the second therapy configuration until either: a subsequent pulse instruction has a holdoff setting allowing concurrent therapy by another therapy configuration; or the controller completes execution of at least the aggregate instruction set that is executing at the time the request to start the second therapy configuration is received.
  11. 11. The implantable medical device as in claim 8, wherein, in response to the request to start the second therapy configuration, the controller is configured to prevent initiation of the second therapy configuration until either: a subsequent pulse instruction has a holdoff setting allowing concurrent therapy by another therapy configuration; or the controller completes execution of the first therapy configuration.
  12. 12. An implantable medical device as in any of claims 1-11, wherein the stimulation circuitry comprises a plurality of digital-to-analog converter circuits including selectable current mirrors, and the total output amplitude is defined in terms of total output current, such that the implantable medical device is configured to deliver current controlled neural stimulation.
  13. 13. The implantable medical device of claim 12, wherein the pulse definition circuit is coupled to the plurality of digital-to-analog converter circuits and is configured to instruct a selected one of the plurality of digital-to-analog converter circuits to use the total output current, and divide the total output current using the selected steering instruction set.
  14. 14. The implantable medical device of any of claims 12-13, wherein the stimulation circuitry comprises a plurality of switches configured to control which electrodes receive current from the plurality of digital to analog converter circuits, and the pulse definition circuit is coupled to the plurality of switches and is configured to control the plurality of switches using the selected steering instruction set.
  15. 15. An implantable deep brain stimulation system or a spinal cord stimulation system comprising the implantable medical device of any of claims 1-14, and a clinician programmer adapted to communicate with the implantable medical device and program each of the arbitration mode and holdoff settings stored in the implantable medical device; wherein: for an implantable deep brain stimulation system, the lead is adapted for placement in the brain of a patient; and for a spinal cord stimulation system the lead is adapted for placement in the spinal column of a patient.

Description

METHOD FOR ARBITRATION BETWEEN PULSES IN A NEUROSTIMULATION DEVICE CROSS REFERENCE TO RELATED APPLICATIONS The present application claims the benefit of US Provisional Patent Application No. 63/532,620, filed August 14, 2023, titled METHOD FOR ARBITRATION BETWEEN PULSES IN A NEUROSTIMULATION DEVICE, the disclosure of which is incorporated herein by reference. BACKGROUND Arbitration logic and/or instructions are used in implantable medical devices to determine the order of execution of multiple therapy programs. For example, US PG Pub. No. 2013/0184794 describes output circuitry for use in neuromodulation devices, such as spinal cord stimulation (SCS) or deep brain stimulation (DBS) devices. The devices may be programmed to issue multiple therapy programs to different or overlapping sets of therapy electrodes. With multiple therapy programs scheduled to issue therapy outputs using the overlapping electrodes and/or output circuitry, timing controls are used so that contrary instructions do not reach the same output-defining circuits at the same time. For example, without arbitration, a single output digital-to-analog converter (DAC) could be commanded to issue a positive one milliamp current at the same time as it is commanded to issue a negative two milliamp current, causing problems with both of the competing therapy programs. Prior systems have used arbitration in a manner which is sometimes not granular enough to allow precise control over therapy programs. As more sophisticated therapy programs are desired with current and future systems, new and/or alternative arbitration schemes are desired. OVERVIEW The present inventors have recognized, among other things, that a problem to be solved is the need for new and/or alternative arbitration schemes are desired. In illustrative examples, a system for therapy definition is used in which therapy phases are defined at a granular level by pulse instructions, grouped together as aggregate instructions which pair pulse instructions with electrode steering instructions, and the aggregate instructions are further grouped together by therapy configurations. Methods and devices for implementing arbitration and/or pulse holdoff timing at the level of pulse instructions are disclosed. Methods and devices for implementing arbitration and/or pulse holdoff timing at the level of aggregate instructions are also disclosed. Finally, methods and devices for implementing arbitration and/or pulse holdoff timing at the level of therapy configurations are also disclosed. A first illustrative and non-limiting example takes the form of an implantable medical device comprising: a housing containing a power source, a controller, and stimulation circuitry; and a lead having a plurality of electrodes thereon, the lead coupled to the housing such that the stimulation circuitry can issue stimulus pulse patterns to a patient via the electrodes; wherein the controller comprises: a memory including steering memory, aggregate memory, pulse memory, and configuration memory; a plurality of pulse definition circuits each including steering logic, aggregate logic, and pulse logic; wherein the steering memory contains steering instruction sets for a plurality of steering programs, each steering program determining which of the electrodes receive a fraction of a total stimulus output, and the steering logic is configured to implement a selected steering instruction set; wherein the pulse memory contains pulse programs, each having a one or more pulse instructions defining pulse components each having a pulse type and one or more determining characteristics for the pulse type; wherein the aggregate memory contains aggregate instructions each defining one or more aggregated outputs, each aggregated output pairing a selected steering instruction set with a selected pulse program and defining a number of repetitions for the selected pulse program to execute with the selected steering instruction set; wherein the configuration memory contains a plurality of therapy configuration instruction sets each having a defined total stimulus output amplitude, an arbitration mode, a holdoff setting, and identifying a one or more aggregate instructions to be executed for each therapy configuration; further wherein the arbitration mode defined in the configuration memory for each therapy configuration instruction set determines whether the therapy configuration instruction sets will wait for completion of portions of other therapy configuration instruction sets before initiating, and the holdoff setting determines whether the therapy configuration instruction set can be interrupted by another therapy configuration instruction set; and wherein the controller is configured to execute the plurality of therapy configurations to generate output pulses using the stimulation circuity by: initiating execution of a first therapy configuration instruction set; while executing the first therapy configuration instruction se