# US 11,298,553 B2 · Multi-mode electrical stimulation systems and methods of making and using

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- Number: US 11,298,553 B2
- Document ID: US11298553B2
- Status: Granted
- Kind: B2
- Application number: 16/396,230
- Filed: 2019-04-26
- Published: 2019-10-31
- Granted: 2022-04-12
- Earliest claimed: 2018-04-27
- Assignees: Boston Scientific Neuromodulation Corporation
- Applicants: Boston Scientific Neuromodulation Corporation
- Inventors: Michael A. Moffitt; Stephen Carcieri
- Web page: https://patentgrep.com/patent/US11298553B2

## CPC

- A61N 1/36062: {Spinal stimulation}
- A61N 1/3727: {characterised by the modulation technique}
- A61N 1/0534: {Electrodes for deep brain stimulation}
- A61N 1/36071: {Pain}
- A61N 1/36132: {using patient feedback}
- A61N 1/36135: {using physiological parameters}
- A61N 1/36139: {with automatic adjustment}
- 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 can facilitate identifying effective electrodes and other stimulation parameters, as well as determining whether to use cathodic and anodic stimulation. Alternately, the methods and systems may identify effective electrodes and other stimulation parameters based on preferential stimulation of different types of neural elements. These methods and systems can further facilitate programming an electrical stimulation system for stimulating patient tissue.

## Claims

### Claim 1

A method for programming electrical stimulation of a patient using an implantable electrical stimulation system comprising an implantable pulse generator and a lead having a plurality of electrodes, the method comprising:
receiving a first response for each of a plurality of first monopolar stimulations performed using at least one of the electrodes of the lead as a cathode, each of the first monopolar stimulations having a set of first stimulation parameters associated with the first monopolar stimulation;
receiving a second response for each of a plurality of second monopolar stimulations performed using at least one of the electrodes of the lead as an anode, each of the second monopolar stimulations having a set of second stimulation parameters associated with the second monopolar stimulation;
selecting, from the sets of first stimulation parameters and the sets of second stimulation parameters, a set of program stimulation parameters for a first stimulation program based on the first and second responses by selecting, from the sets of first stimulation parameters and the sets of second stimulation parameters, the set of program stimulation parameters that produces a most beneficial therapeutic effect without side-effects;
receiving direction to program the implantable pulse generator with the set of program stimulation parameters; and
initiating a signal that provides the implantable pulse generator of the electrical stimulation system with the set of program stimulation parameters for generating electrical stimulation for the patient through the electrodes of the lead.

### Claim 2 (depends on 1)

The method of claim 1, wherein receiving a first response comprises receiving a first quantitative or qualitative indication of at least one therapeutic effect and receiving a second response comprises receiving a second quantitative or qualitative indication of at least one therapeutic effect.

### Claim 3 (depends on 1)

The method of claim 1, wherein receiving the first response comprises receiving a first quantitative or qualitative indication of at least one therapeutic effect, at least one side-effect, or any combination thereof and receiving the second response comprises receiving a second quantitative or qualitative indication of at least one therapeutic effect, at least one side-effect, or any combination thereof.

### Claim 4 (depends on 3)

The method of claim 3, wherein selecting the set of program stimulation parameters comprises selecting the set of program stimulation parameters based on the first and second quantitative or qualitative indications.

### Claim 5 (depends on 1)

The method of claim 1, wherein receiving the first response comprising receiving the first response from a clinician or patient.

### Claim 6 (depends on 1)

The method of claim 1, wherein receiving the first response comprising receiving the first response from a sensor.

### Claim 7 (depends on 1)

The method of claim 1, wherein receiving the first response comprises rating the first response for each of the plurality of first monopolar stimulations.

### Claim 8 (depends on 7)

The method of claim 7, wherein receiving the second response comprises rating the second response for each of the plurality of second monopolar stimulations.

### Claim 9 (depends on 8)

The method of claim 8, wherein the ratings of the first and second monopolar stimulations are on a scale of numbers based on at least one or more beneficial therapeutic effects.

### Claim 10 (depends on 9)

The method of claim 9, wherein the ratings of the first and second monopolar stimulations are on the scale of numbers based on at least one or more beneficial therapeutic effects and presence or absence of one or more side-effects.

### Claim 11 (depends on 1)

The method of claim 1, wherein at least one of the first monopolar stimulations and at least one of the second monopolar stimulations utilize a same subset of the electrodes for the at least one of the first monopolar stimulations and the at least one of the second monopolar stimulations.

### Claim 12 (depends on 1)

The method of claim 1, further comprising receiving a third response for each of a plurality of multipolar stimulations performed using at least one of the electrodes of the lead as an anode and at least one of the electrodes of the lead as a cathode, each of the multipolar stimulations having a set of third stimulation parameters associated with the multipolar stimulation.

### Claim 13 (depends on 1)

The method of claim 1, wherein selecting the set of program stimulation parameters comprises selecting, from the sets of first stimulation parameters and the sets of second stimulation parameters, the set of program stimulation parameters that produces a most beneficial therapeutic effect.

### Claim 14 (depends on 1)

The method of claim 1, wherein receiving the first response comprises rating the first response for each of the plurality of first monopolar stimulations, wherein receiving the second response comprises rating the second response for each of the plurality of second monopolar stimulations and, wherein selecting the set of program stimulation parameters comprises selecting the set of program stimulation parameters based on the ratings of the first and second responses.

### Claim 15 (depends on 1)

The method of claim 1, further comprising performing each of the plurality of first monopolar stimulations by stimulating the patient using the at least one of the electrodes of the lead as the cathode.

### Claim 16 (depends on 15)

The method of claim 15, further comprising performing each of the plurality of second monopolar stimulations by stimulating the patient using the at least one of the electrodes of the lead as the anode.

### Claim 17 (depends on 16)

The method of claim 16, further comprising
performing a plurality of multipolar stimulations by stimulating the patient using at least one of the electrodes of the lead as an anode and at least one of the electrodes of the lead as a cathode, each of the multipolar stimulations having a set of third stimulation parameters associated with the multipolar stimulation; and
receiving a third response for each of the plurality of multipolar stimulations.

### Claim 18

A method for programming electrical stimulation of a patient using an implantable electrical stimulation system comprising an implantable pulse generator and a lead having a plurality of electrodes, the method comprising:
receiving a first response for each of a plurality of first monopolar stimulations performed using at least one of the electrodes of the lead as a cathode, each of the first monopolar stimulations having a set of first stimulation parameters associated with the first monopolar stimulation;
receiving a second response for each of a plurality of second monopolar stimulations performed using at least one of the electrodes of the lead as an anode, each of the second monopolar stimulations having a set of second stimulation parameters associated with the second monopolar stimulation;
selecting, from the sets of first stimulation parameters and the sets of second stimulation parameters, a set of program stimulation parameters for a first stimulation program based on the first and second responses by selecting, from the sets of first stimulation parameters and the sets of second stimulation parameters, the set of program stimulation parameters that produces a most beneficial therapeutic effect with a level of side-effects below a threshold;
receiving direction to program the implantable pulse generator with the set of program stimulation parameters; and
initiating a signal that provides the implantable pulse generator of the electrical stimulation system with the set of program stimulation parameters for generating electrical stimulation for the patient through the electrodes of the lead.
