# US 9,872,992 B2 · System and method for estimating location and depth of stimulation leads

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- Number: US 9,872,992 B2
- Document ID: US9872992B2
- Status: Granted
- Kind: B2
- Application number: 13/796,022
- Filed: 2013-03-12
- Published: 2013-09-19
- Granted: 2018-01-23
- Earliest claimed: 2012-03-16
- Assignees: Boston Scientific Neuromodulation Corporation
- Applicants: Boston Scientific Neuromodulation Corporation
- Inventors: Changfang Zhu; Kerry Bradley
- Web page: https://patentgrep.com/patent/US9872992B2

## CPC

- A61N 1/37211: {Means for communicating with stimulators}
- A61N 1/37247: {User interfaces, e.g. input or presentation means}
- A61N 1/37264: {Changing the program; Upgrading firmware}
- 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

A method and external control device for performing a medical procedure on a patient in which at least one stimulation lead is implanted. An electrical signal is conveyed from the stimulation lead into tissue of the patient. An electrical parameter indicative of tissue impedance is measured in response to the conveyance of the electrical signal. One of a plurality of different anatomical regions in which the stimulation lead is implanted is selected and/or a depth in which the stimulation is implanted is determined based on the measured electrical parameter. A stimulation parameter is defined based on the selected one anatomical region and/or implantation depth. Electrical stimulation energy from the stimulation lead is conveyed into the one determined anatomical region in accordance with the defined stimulation parameter.

## Claims

### Claim 1

An external control device for use with a stimulation device capable of conveying an electrical signal to a stimulation lead implanted within a patient, and measuring an electrical parameter in response to the conveyance of the electrical signal, comprising:
telemetry circuitry configured for communicating with a stimulation device;
a processor configured for receiving the measured electrical parameter from the stimulation device via the telemetry circuitry, selecting one of a plurality of different anatomical regions in which the stimulation lead is implanted based on the measured electrical parameter, and defining a stimulation parameter based on the selected anatomical region; and
a controller configured for instructing the stimulation device via the telemetry circuitry to convey electrical stimulation energy from the stimulation lead in accordance with the defined stimulation parameter.

### Claim 2 (depends on 1)

The external control device of claim 1, wherein the electrical parameter is measured at another stimulation lead implanted within the patient.

### Claim 3 (depends on 1)

The external control device of claim 1, wherein the processor is further configured for comparing the measured electrical parameter to a plurality of threshold ranges, and selecting the one anatomical region from the plurality of different anatomical regions based on the comparison.

### Claim 4 (depends on 3)

The external control device of claim 3, wherein the different anatomical regions comprise a spinal epidural space and a peripheral tissue region.

### Claim 5 (depends on 4)

The external control device of claim 4, wherein the measured electrical parameter is indicative of a tissue impedance, a first one of the threshold ranges is relatively low, and a second one of the threshold ranges is relatively high, and the processor is configured for selecting the anatomical region to be the spinal epidural space if the implied tissue impedance is within the first threshold range, and selecting the anatomical region to be the peripheral tissue region if the implied tissue impedance is within the second threshold range.

### Claim 6 (depends on 1)

The external control device of claim 1, wherein the at least one stimulation parameter comprises an electrode combination.

### Claim 7 (depends on 1)

The external control device of claim 1, further comprising a user interface configured for displaying a plurality of different programming screens respectively associated with different anatomical regions of a patient, selecting one of the programming screens corresponding to the selected anatomical region, and allowing a user to define the stimulation parameter using the selected programming screen.

### Claim 8 (depends on 7)

The external control device of claim 7, wherein:
the processor is further configured for computing a confidence rating for the plurality of different anatomical regions based on the measured electrical parameter; and
the user interface is further configured for conveying information to a user identifying the different anatomical regions and associated computed confidence rating, and allowing the user to select the one anatomical region from the plurality of different anatomical regions based on computed confidence rating.

### Claim 9 (depends on 1)

A method of performing a medical procedure on a patient using the external control device of claim 1, comprising:
conveying the electrical signal from the stimulation lead into tissue of the patient;
measuring the electrical parameter in response to the conveyance of the electrical signal;
selecting one of the plurality of different anatomical regions in which the stimulation lead is implanted based on the measured electrical parameter;
defining the stimulation parameter based on the selected one anatomical region; and
conveying the electrical stimulation energy from the stimulation lead into the one determined anatomical region in accordance with the defined stimulation parameter.

### Claim 10 (depends on 9)

The method of claim 9, wherein the electrical parameter is measured at another stimulation lead implanted within the patient.

### Claim 11 (depends on 9)

The method of claim 9, further comprising comparing the measured electrical parameter to a plurality of threshold ranges, wherein the one anatomical region is selected from the plurality of different anatomical regions based on the comparison.

### Claim 12 (depends on 11)

The method of claim 11, wherein the different anatomical regions comprise a spinal epidural space and a peripheral tissue region.

### Claim 13 (depends on 12)

The method of claim 12, wherein the measured electrical parameter is indicative of a tissue impedance, a first one of the threshold ranges is relatively low, a second one of the threshold ranges is relatively high, the anatomical region is selected to be the spinal epidural space if the tissue impedance is within the first threshold range, and the anatomical region is selected to be the peripheral tissue region if the tissue impedance is within the second threshold range.

### Claim 14 (depends on 9)

The method of claim 9, wherein the stimulation parameter comprises an electrode combination.

### Claim 15 (depends on 9)

The method of claim 9, further comprising:
computing a confidence rating for the plurality of different anatomical regions based on the measured electrical parameter;
conveying information to a user identifying the different anatomical regions and associated computed confidence rating; and
allowing the user to select the one anatomical region from the plurality of different anatomical regions based on computed confidence rating.
