# US 2015/0148867 A1 · Systems and methods for monitoring neurostimulation dosing

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- Number: US 2015/0148867 A1
- Document ID: US20150148867A1
- Status: Published application
- Kind: A1
- Application number: 14/612,799
- Filed: 2015-02-03
- Published: 2015-05-28
- Earliest claimed: 2012-03-19
- Assignees: Cardiac Pacemakers, Inc.
- Applicants: Cardiac Pacemakers, Inc.
- Inventors: Doug M. Birkholz; Douglas J. Brandner; Douglas J. Gifford; David J. Ternes; William J. Linder
- Web page: https://patentgrep.com/patent/US20150148867A1

## CPC

- A61N 1/3727: {characterised by the modulation technique}
- A61N 1/3605: {Implantable neurostimulators for stimulating central or peripheral nerve system}
- A61N 1/36082: {Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease}
- A61N 1/36125: {Details of circuitry or electric components}
- A61N 1/36142: {for improving safety}
- A61N 1/36178: {Burst or pulse train parameters}
- A61N 1/378: Electrical supply
- 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

Various implantable device embodiments may comprise a neural stimulator configured to deliver a neurostimulation therapy with stimulation ON times and stimulation OFF times where a dose of the neurostimulation therapy is provided by a number of neurostimulation pulses over a period of time. The neural stimulator may be configured to monitor the dose of the delivered neurostimulation therapy against dosing parameters. The neural stimulator may be configured to declare a fault if the monitored dose does not favorably compare to a desired dose for the neurostimulation therapy, or may be configured to record data for the monitored dose of the delivered neurostimulation therapy, or may be configured to both record data fir the monitored dose of the delivered neurostimulation therapy and declare a fault if the monitored dose does riot favorably compare to a desired dose for the neurostimulation therapy.

## Claims

### Claim 1

(canceled)

### Claim 2

An implantable medical device, comprising:
a neural stimulator configured to deliver a neurostimulation therapy with a neural stimulation pulse frequency, wherein a dose of the neurostimulation therapy is provided by a number of neurostimulation pulses over a period of time, wherein the neural stimulator includes a clock with an oscillator, a hardware state machine operationally connected to the clock to provide pulse timing control signals, and pulse circuitry configured to receive the timing control signals and deliver neurostimulation pulses with a pulse frequency controlled using the timing control signals, the pulse circuitry including a frequency output limiter configured to avoid excessive charge delivery.

### Claim 3 (depends on 2)

The device of claim 2, wherein the output limiter is configured to bloc purse from being issued for a period of time after a preceding pulse.

### Claim 4 (depends on 2)

The device of claim 2, wherein the output limiter includes a programmable frequency output limiter configured to block a pulse from being issued for a programmable period of time after a preceding pulse.

### Claim 5 (depends on 2)

The device of claim 2, wherein the device is configured to declare a fault when a defined number of pulses are blocked by the frequency output limiter, the defined number of pulses being one or more pulses.

### Claim 6 (depends on 2)

The device of claim 2, wherein the device includes a charge consumption monitor, and declare a fault if the charge consumption is not within the dosing parameters.

### Claim 7 (depends on 6)

The device of claim 6, further comprising a power supply, wherein the charge consumption monitor is configured to measure charge depletion from the power supply.

### Claim 8 (depends on 6)

The device of claim 6, wherein the neural stimulator is configured to deliver neurostimulation pulses through at least one lead, and the charge consumption monitor is configured to monitor charge or current flow to the at least one lead.

### Claim 9 (depends on 6)

The device of claim 6, wherein the charge consumption monitor includes a coulomb counter.

### Claim 10 (depends on 6)

The device of claim 6, wherein the charge consumption monitor is configured to implement a rolling average and tiered threshold levels to declare the fault.

### Claim 11 (depends on 2)

The device of claim 2, wherein the device is configured to perform a device action in response to the fault, wherein the device action includes stopping or altering the neurostimulation therapy in response to the fault.

### Claim 12

A method, comprising:
delivering a neurostimulation therapy with a neural stimulation pulse frequency, wherein a dose of the neurostimulation therapy is provided by a number of neurostimulation pulses over a period of time, wherein delivering the neural stimulation therapy includes providing pulse timing control signals using a clock with an oscillator and a hardware state machine operationally connected to the clock, and further includes using pulse circuitry to receive the timing control signals and deliver neurostimulation pulses with a pulse frequency controlled using the timing control signals and using a frequency output limiter to avoid excessive charge delivery.

### Claim 13 (depends on 12)

The method of claim 12, wherein using the frequency output limiter to avoid excessive charge delivery includes using the frequency output limiter to block a pulse from being issued fur a period of time after a preceding pulse.

### Claim 14 (depends on 12)

The method of claim 12, wherein using the frequency output limiter to avoid excessive charge delivery includes using a programmable frequency output limiter to block a pulse from being issued fur a programmable period of time after a preceding pulse.

### Claim 15 (depends on 12)

The method of claim 12, further comprising declaring a fault when a defined number of pulses are blocked by the frequency output limiter, the defined number of pulses being one or more pulses.

### Claim 16 (depends on 12)

The method of claim 12, further comprising monitoring charge consumption and declaring a fault if the charge consumption is not within the dosing parameters.

### Claim 17 (depends on 16)

The method of claim 16, wherein monitoring charge consumption includes measuring charge depletion from the power supply.

### Claim 18 (depends on 16)

The method of claim 16, wherein monitoring charge consumption includes monitoring charge or current flow to at least one lead.

### Claim 19 (depends on 16)

The method of claim 16, wherein monitoring charge consumption includes using a coulomb counter to monitor charge consumption.

### Claim 20 (depends on 16)

The method of claim 16, wherein monitoring charge consumption includes using a rolling average of coulomb use and tiered threshold levels to declare the fault.

### Claim 21 (depends on 12)

The method of claim 12, further comprising stopping or altering the neurostimulation therapy in response to the fault.