# US 12,179,024 B2 · Methods and systems for target localization and DBS therapy

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 12,179,024 B2
- Document ID: US12179024B2
- Status: Granted
- Kind: B2
- Application number: 18/483,265
- Filed: 2023-10-09
- Published: 2024-02-01
- Granted: 2024-12-31
- Earliest claimed: 2021-03-18
- Assignees: Boston Scientific Neuromodulation Corporation
- Applicants: Boston Scientific Neuromodulation Corporation
- Inventors: Rosana Esteller; Mahsa Malekmohammadi; Andrew Haddock; Tianhe Zhang
- Web page: https://patentgrep.com/patent/US12179024B2

## CPC

- A61B 5/377: using evoked responses
- A61N 1/3614: {based on impedance measurement}
- A61B 5/065: {Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe}
- A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)}
- A61N 1/0534: {Electrodes for deep brain stimulation}
- A61N 1/08: Arrangements or circuits for monitoring, protecting, controlling or indicating {(for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925)}
- A61N 1/36067: {Movement disorders, e.g. tremor or Parkinson disease (stimulating motor muscle A61N1/36003)}
- A61N 1/36185: {Selection of the electrode configuration}
- A61N 2001/083: {Monitoring integrity of contacts, e.g. by impedance measurement}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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

Methods and systems are described for detecting if a stimulation lead implanted in a patient's brain has moved. Lead movement occurring between a first time and a second time may be determined by comparing features extracted from evoked potentials recorded at the two times. The disclosed methods and systems are particularly useful for determining if a stimulation lead has moved between the time it was implanted in the patient's brain and the time that stimulation parameters are being optimized. Lead movement during implantation, during parameter optimization, and during or between other lead optimization processes may be determined as well.

## Claims

### Claim 1

A method of optimizing a position on an electrode lead implanted in a patient's brain for providing deep brain stimulation (DBS) to the patient's brain, the lead comprising a plurality of electrodes, the method comprising:
(a) determining an optimized stimulation waveform for evoking a detectable evoked potential by:
using one or more of the electrodes to provide an initial stimulation waveform, and
adjusting one or more parameters of the initial stimulation waveform until first evoked potentials are detectable using one or more of the electrodes,
(b) determining an optimized longitudinal stimulation position along an axis of the lead by:
providing stimulation at different longitudinal positions along the axis of the lead using the optimized stimulation waveform,
recording second evoked potentials evoked by the stimulation at each of the longitudinal positions,
comparing each of the second evoked potentials with each other, and
selecting the optimized longitudinal stimulation position based on the second evoked potentials, and
(c) determining an optimized rotational stimulation position about the axis of the lead by:
at the selected optimized longitudinal stimulation position providing stimulation at different rotational positions about the axis of the lead using the optimized stimulation waveform,
recording third evoked potentials evoked by the stimulation at each of the rotational positions, and
selecting the optimized rotational stimulation position based on the third evoked potential.

### Claim 2 (depends on 1)

The method of claim 1, wherein the initial stimulation waveform comprises a first phase of a first polarity, as second phase of a second polarity, and an interphase interval.

### Claim 3 (depends on 1)

The method of claim 1, wherein adjusting a parameter of the initial stimulation waveform comprises adjusting an amplitude of the waveform.

### Claim 4 (depends on 1)

The method of claim 1, wherein providing stimulation at different longitudinal positions comprises fractionating current among two or more of the electrodes to provide stimulation at one or more virtual electrodes that are not co-located with any of the plurality of electrodes.

### Claim 5 (depends on 1)

The method of claim 1, wherein providing stimulation at different rotational positions comprises fractionating current among two or more directional electrodes to provide stimulation at one or more virtual electrodes that are not co-located with any of the directional electrodes.

### Claim 6 (depends on 1)

The method of claim 1, wherein selecting the optimized longitudinal position based on the second evoked potential comprises determining values for one or more features of the second evoked potentials and selecting the optimized longitudinal position based on the values.

### Claim 7 (depends on 1)

The method of claim 1, wherein selecting the optimized rotational position based on the third evoked potential comprises determining values for one or more features of the third evoked potentials and selecting the optimized longitudinal position based on the values.

### Claim 8 (depends on 1)

The method of claim 1, further comprising determining an indication that efficacy of therapy for the patient has declined and automatically performing the method in response to the indication.

### Claim 9 (depends on 8)

The method of claim 8, wherein the indication that efficacy of therapy has declined is based, at least in part, on recorded evoked potentials that are recorded while the patient is undergoing DBS stimulation.

### Claim 10 (depends on 9)

The method of claim 9, wherein the indication that efficacy of therapy has declined is based, at least in part, on impedances determined at one or more of the electrodes while the patient is undergoing DBS stimulation.

### Claim 11

A medical device configured to optimize a position on an electrode lead implanted in a patient's brain for providing deep brain stimulation (DBS) to the patient's brain, the lead comprising a plurality of electrodes, the device comprising:
control circuitry configured to:
(a) determine an optimized stimulation waveform for evoking a detectable evoked potential by:
using one or more of the electrodes to provide an initial stimulation waveform, and
adjusting one or more parameters of the initial stimulation waveform until first evoked potentials are detectable using one or more of the electrodes,
(b) determine an optimized longitudinal stimulation position along an axis of the lead by:
providing stimulation at different longitudinal positions along the axis of the lead using the optimized stimulation waveform,
recording second evoked potentials evoked by the stimulation at each of the longitudinal positions,
comparing the each of the second evoked potentials with each other, and
selecting the optimized longitudinal stimulation position based on the second evoked potentials, and
(c) determine an optimized rotational stimulation position about the axis of the lead by:
at the selected optimized longitudinal stimulation position providing stimulation at different rotational positions about the axis of the lead using the optimized stimulation waveform,
recording third evoked potentials evoked by the stimulation at each of the rotational positions, and
selecting the optimized rotational stimulation position based on the third evoked potentials.

### Claim 12 (depends on 11)

The device of claim 11, wherein the initial stimulation waveform comprises a first phase of a first polarity, as second phase of a second polarity, and an interphase interval.

### Claim 13 (depends on 11)

The device of claim 11, wherein adjusting a parameter of the initial stimulation waveform comprises adjusting an amplitude of the waveform.

### Claim 14 (depends on 11)

The device of claim 11, wherein providing stimulation at different longitudinal positions comprises fractionating current among two or more of the electrodes to provide stimulation at one or more virtual electrodes that are not co-located with any of the plurality of electrodes.

### Claim 15 (depends on 11)

The device of claim 11, wherein providing stimulation at different rotational positions comprises fractionating current among two or more directional electrodes to provide stimulation at one or more virtual electrodes that are not co-located with any of the directional electrodes.

### Claim 16 (depends on 11)

The device of claim 11, wherein selecting the optimized longitudinal position based on the second evoked potential comprises determining values for one or more features of the second evoked potentials and selecting the optimized longitudinal position based on the values.

### Claim 17 (depends on 11)

The device of claim 11, wherein selecting the optimized rotational position based on the third evoked potential comprises determining values for one or more features of the third evoked potentials and selecting the optimized longitudinal position based on the values.

### Claim 18 (depends on 11)

The device of claim 11, configured to determine an indication that efficacy of therapy for the patient has declined and automatically performing the method in response to the indication.

### Claim 19 (depends on 18)

The device of claim 18, wherein the indication that efficacy of therapy has declined is based, at least in part, on recorded evoked potentials that are recorded while the patient is undergoing DBS stimulation.

### Claim 20 (depends on 19)

The device of claim 19, wherein the indication that efficacy of therapy has declined is based, at least in part, on impedances determined at one or more of the electrodes while the patient is undergoing DBS stimulation.
