# US 12,005,257 B2 · Neuromodulation therapy with custom instruction set architecture for a stimulation engine system

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- Number: US 12,005,257 B2
- Document ID: US12005257B2
- Status: Granted
- Kind: B2
- Application number: 17/405,804
- Filed: 2021-08-18
- Published: 2023-03-02
- Granted: 2024-06-11
- Earliest claimed: 2021-08-18
- Assignees: Advanced Neuromodulation Systems, Inc.
- Applicants: Advanced Neuromodulation Systems, Inc.
- Inventors: Gavin Rade; Daran DeShazo
- Web page: https://patentgrep.com/patent/US12005257B2

## CPC

- A61N 1/36167: {Timing, e.g. stimulation onset}
- A61N 1/025: {Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors}
- A61N 1/36132: {using patient feedback}
- A61N 1/37223: {Circuits for electromagnetic coupling}
- A61N 1/37247: {User interfaces, e.g. input or presentation means}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

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.

## Claims

### Claim 1

A method of operating an implantable medical device (IMD) for providing stimulation therapy to a patient, the IMD including one or more stimulation engines (SEs) operatively coupled to at least one implantable lead having a plurality of electrodes positioned proximate to a tissue of the patient, the method comprising:
generating, by a first processor of the IMD operative with a first clock frequency, a set of pulse definitions and a set of timing definitions corresponding to a therapy program selection received from an external device responsive to a user input thereat;
storing the respective sets of pulse definitions and timing definitions in a storage area;
generating, by the first processor, a sequence of assembly-language like (ALL) instructions for execution by a second processor of the IMD operative with a second clock frequency that is lower than the first clock frequency, the second processor configured to control the one or more SEs for generating one or more pulse waveforms; and
executing at least a portion of the ALL instructions by the second processor for causing the one or more SEs to generate a particular sequence of therapy pulses according to the therapy program selection based on respective combinations of pulse definitions and timing definitions applied over a time base in accordance with the executed ALL instructions.

### Claim 2 (depends on 1)

The method as recited in claim 1, wherein the at least a portion of the ALL instructions are executed by the second processor using instruction pipelining.

### Claim 3 (depends on 1)

The method as recited in claim 1, wherein the time base is derived from the second clock frequency of the second processor, the time base comprising a clock signal, and further wherein a verification is performed at each clock edge of the clock signal to determine whether there are any pending instructions to be executed.

### Claim 4 (depends on 1)

The method as recited in claim 1, wherein the therapy program selection comprises selecting a therapy program having a tonic stimulation pattern, a burst stimulation pattern, a high-frequency stimulation pattern, a sub-paresthesia stimulation pattern, a non-paresthesia stimulation pattern, a biphasic pulse stimulation pattern or a monophasic pulse stimulation pattern.

### Claim 5 (depends on 1)

The method as recited in claim 1, wherein the therapy program selection comprises selecting a therapy program for effectuating a spinal cord stimulation (SCS) therapy, a neuromuscular stimulation therapy, a dorsal root ganglion (DRG) stimulation therapy, a deep brain stimulation (DBS) therapy, a cochlear stimulation therapy, a cardiac pacemaker therapy, a cardioverter-defibrillator therapy, a cardiac rhythm management (CRM) therapy, an electrophysiology (EP) mapping and radio frequency (RF) ablation therapy, an electroconvulsive therapy (ECT), a repetitive transcranial magnetic stimulation (rTMS) therapy, or a vagal nerve stimulation (VNS) therapy.

### Claim 6 (depends on 1)

The method as recited in claim 1, wherein the therapy program selection is received from a clinician programmer device operating as the external device responsive to a clinician input.

### Claim 7 (depends on 1)

The method as recited in claim 1, wherein the therapy program selection is received from a patient controller device operating as the external device responsive to an input by the patient.