# US 12,594,424 B2 · Systems and methods for estimating a volume of activation using a compressed database of threshold values

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- Number: US 12,594,424 B2
- Document ID: US12594424B2
- Status: Granted
- Kind: B2
- Application number: 17/731,190
- Filed: 2022-04-27
- Published: 2022-08-11
- Granted: 2026-04-07
- Earliest claimed: 2017-04-03
- Assignees: Boston Scientific Neuromodulation Corporation
- Applicants: Boston Scientific Neuromodulation Corporation
- Inventors: G. Karl Steinke; Richard Mustakos
- Web page: https://patentgrep.com/patent/US12594424B2

## CPC

- A61N 1/36128: {Control systems}
- A61N 1/025: {Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors}
- A61N 1/0534: {Electrodes for deep brain stimulation}
- A61N 1/36185: {Selection of the electrode configuration}
- A61N 1/37247: {User interfaces, e.g. input or presentation means}
- A61N 1/37282: {characterised by communication with experts in remote locations using a network}
- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- G16H 40/63: for local operation
- G16H 50/70: for mining of medical data, e.g. analysing previous cases of other patients
- 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)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

A system for estimating a volume of activation around an implanted electrical stimulation lead for a set of stimulation parameters includes a display; and a processor coupled to the display and configured to: receive a set of stimulation parameters including a stimulation amplitude and a selection of one of more electrodes of the implanted electrical stimulation lead for delivery of the stimulation amplitude; determine an estimate of the volume of activation based on the set of stimulation parameters using the stimulation amplitude and a database including a plurality of planar distributions of stimulation threshold values and a map relating the planar distributions to spatial locations based on the one or more electrodes of the implanted electrical stimulation lead selected for delivery of the stimulation amplitude; and output on the display a graphical representation of the estimate of the volume of activation.

## Claims

### Claim 1

A method for estimating a volume of activation around an implanted electrical stimulation lead for a set of stimulation parameters, the method comprising:
providing a database comprising a plurality of planar distributions of stimulation threshold values and an index identifying the planar distributions that correspond to angular locations around the implanted electrical stimulation lead based on a selection of one or more electrodes of the implanted electrical stimulation lead for delivery of stimulation, wherein each of the planar distributions represents a set of regions in a plane relative to the implanted electrical stimulation lead and each of the stimulation threshold values corresponds to a different one of the regions and comprises a stimulation amplitude that when applied to the selected one or more electrodes of the implanted electrical stimulation lead will stimulate tissue at the one of the regions corresponding to the stimulation threshold value;
receiving a set of stimulation parameters comprising a first stimulation amplitude and a first selection of one of more electrodes of the implanted electrical stimulation lead for delivery of the first stimulation amplitude;
determining an estimate of the volume of activation using the first stimulation amplitude, the first selection of one or more electrodes of the implanted electrical stimulation lead, and the database; and
displaying a graphical representation of the estimate of the volume of activation.

### Claim 2 (depends on 1)

The method of claim 1, wherein the database consists of the plurality of planar distributions, wherein each of the planar distributions is unique.

### Claim 3 (depends on 2)

The method of claim 2, wherein the database is a lossless compressed database.

### Claim 4 (depends on 2)

The method of claim 2, wherein the database is a lossy compressed database.

### Claim 5

A system for estimating a volume of activation around an implanted electrical stimulation lead for a set of stimulation parameters, the system comprising:
a display; and
a processor coupled to the display and configured to:
provide a database comprising a plurality of planar distributions of stimulation threshold values and an index identifying the planar distributions that correspond to angular locations around the implanted electrical stimulation lead based on a selection of one or more electrodes of the implanted electrical stimulation lead for delivery of stimulation, wherein each of the planar distributions represents a set of regions in a plane relative to the implanted electrical stimulation lead and each of the stimulation threshold values corresponds to a different one of the regions and comprises a stimulation amplitude that when applied to the selected one or more electrodes of the implanted electrical stimulation lead will stimulate tissue at the one of the regions corresponding to the stimulation threshold value;
receive a set of stimulation parameters comprising a first stimulation amplitude and a first selection of one of more electrodes of the implanted electrical stimulation lead for delivery of the first stimulation amplitude;
determine an estimate of the volume of activation using the first stimulation amplitude, the first selection of one or more electrodes of the implanted electrical stimulation lead, and the database; and
output on the display a graphical representation of the estimate of the volume of activation.

### Claim 6 (depends on 5)

The system of claim 5, wherein the selection of the one or more electrodes is characterized by at least one fractionalization parameter.

### Claim 7 (depends on 6)

The system of claim 6, wherein the at least one fractionalization parameter comprises at least one of an axial position parameter, an angular direction parameter, or an angular spread parameter.

### Claim 8 (depends on 5)

The system of claim 5, wherein the first selection of the one or more electrodes is characterized by at least one of an axial position parameter, an angular direction parameter, or an angular spread parameter.

### Claim 9 (depends on 5)

The system of claim 5, wherein the index comprises a plurality of entries, wherein each of the entries is indexed to the selection of the one or more electrodes and an angular location around the implanted electrical stimulation lead.

### Claim 10 (depends on 9)

The system of claim 9, wherein at least two of the entries of the index point to a same planar distribution.

### Claim 11 (depends on 10)

The system of claim 10, wherein the at least two of the entries comprise a first entry indexed to a selection of a first one of the electrodes and a first angular location and a second entry indexed to a selection of a second one of the electrodes and a second angular location, wherein the first angular location and the second angular location differ by a first angle, wherein a location of the first one of the electrodes differs from a location of the second one of the electrodes by the first angle.

### Claim 12 (depends on 5)

The system of claim 5, wherein the database consists of the plurality of planar distributions, wherein each of the planar distributions is unique.

### Claim 13 (depends on 12)

The system of claim 12, wherein the database is a lossless compressed database.

### Claim 14 (depends on 12)

The system of claim 12, wherein the database is a lossy compressed database.

### Claim 15

A non-transitory computer-readable medium having computer executable instructions stored thereon that, when executed by at least one processor, cause the at least one processor to perform the instructions, the instructions comprising:
providing a database comprising a plurality of planar distributions of stimulation threshold values and an index identifying the planar distributions that correspond to angular locations around the implanted electrical stimulation lead based on a selection of one or more electrodes of the implanted electrical stimulation lead for delivery of stimulation, wherein each of the planar distributions represents a set of regions in a plane relative to the implanted electrical stimulation lead and each of the stimulation threshold values corresponds to a different one of the regions and comprises a stimulation amplitude that when applied to the selected one or more electrodes of the implanted electrical stimulation lead will stimulate tissue at the one of the regions corresponding to the stimulation threshold value;
receiving a set of stimulation parameters comprising a first stimulation amplitude and a first selection of one of more electrodes of the implanted electrical stimulation lead for delivery of the first stimulation amplitude;
determining an estimate of the volume of activation using the first stimulation amplitude, the first selection of one or more electrodes of the implanted electrical stimulation lead, and the database; and
displaying a graphical representation of the estimate of the volume of activation.

### Claim 16 (depends on 15)

The non-transitory computer-readable medium of claim 15, wherein the index comprises a plurality of entries, wherein each of the entries is indexed to the selection of the one or more electrodes and an angular location around the implanted electrical stimulation lead.

### Claim 17 (depends on 16)

The non-transitory computer-readable medium of claim 16, wherein at least two of the entries of the index point to a same planar distribution.

### Claim 18 (depends on 15)

The non-transitory computer-readable medium of claim 15, wherein the database consists of the plurality of planar distributions, wherein each of the planar distributions is unique.

### Claim 19 (depends on 18)

The non-transitory computer-readable medium of claim 18, wherein the database is a lossless compressed database.

### Claim 20 (depends on 18)

The non-transitory computer-readable medium of claim 18, wherein the database is a lossy compressed database.
