# US 9,517,333 B2 · Lead identification system

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- Number: US 9,517,333 B2
- Document ID: US9517333B2
- Status: Granted
- Kind: B2
- Application number: 13/898,845
- Filed: 2013-05-21
- Published: 2014-11-27
- Granted: 2016-12-13
- Earliest claimed: 2011-08-31
- Assignees: Nuvectra Corporation
- Applicants: Nuvectra Corporation
- Inventors: Richard North; Scott Drees; John M. Swoyer; Lawrence Kane; Jesse Geroy; Shahn Sage; Elliot Bridgeman; James Finley
- Web page: https://patentgrep.com/patent/US9517333B2

## CPC

- A61N 1/0558: {Anchoring or fixation means therefor}
- A61B 90/90: Identification means for patients or instruments, e.g. tags
- A61B 90/92: coded with colour
- A61B 90/94: coded with symbols, e.g. text
- A61N 1/37241: {providing test stimulations}
- A61B 2090/3937: {Visible markers}
- A61B 2090/3962: {palpable}
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

In some examples, a lead identification system includes a first set of first lead indicators and a second set of second lead indicators. Each of the first lead indicators is configured to removably attach to at least one of a first therapy delivery element, a first epidural needle, or a first connector to uniquely identify at least one of the first therapy delivery element, the first epidural needle, or the first connector during implantation of the first therapy delivery element in the patient. Each of the second lead indicators is configured to removably attach to at least one of a second therapy delivery element, a second epidural needle, or a second connector to uniquely identify at least one of the second therapy delivery element, the second epidural needle, or the second connector during implantation of the second therapy delivery element in the patient.

## Claims

### Claim 1

A lead identification system for tracking at least two therapy delivery elements during implantation in a patient, each of the therapy delivery elements being configured to be implanted using one of at least two epidural needles, the lead identification system comprising:
a first set of first lead indicators, each of the first lead indicators configured to removably attach to at least one of a first therapy delivery element, a first epidural needle, or a first connector to uniquely identify at least one of the first therapy delivery element, the first epidural needle, or the first connector during implantation of the first therapy delivery element in the patient; and
a second set of second lead indicators, each of the second lead indicators configured to removably attach to at least one of a second therapy delivery element, a second epidural needle, or a second connector to uniquely identify at least one of the second therapy delivery element, the second epidural needle, or the second connector during implantation of the second therapy delivery element in the patient.

### Claim 2 (depends on 1)

The lead identification system of claim 1, wherein each of the first lead indicators of the first set includes a first color indicator and each of the second lead indicators of the second set includes a second color indicator, the first color indicator being different from the second color indicator.

### Claim 3 (depends on 1)

The lead identification system of claim 1, wherein each of the first lead indicators of the first set includes a first tactile indicator, and each of the second lead indicators of the second set includes a second tactile indicator, the first tactile indicator being different from the second tactile indicator.

### Claim 4 (depends on 1)

The lead identification system of claim 1, wherein each of the first lead indicators of the first set includes a first alpha-numeric indicator and each of the second lead indicators of the second set includes a second alpha-numeric indicator, the first alpha-numeric indicator being different from the second alpha-numeric indicator.

### Claim 5 (depends on 1)

The lead identification system of claim 1, wherein the first set includes a first needle lead indicator, and the second set includes a second needle lead indicator, the first needle lead indicator being removably attachable to the first epidural needle, and the second needle lead indicator being removably attachable to the second epidural needle.

### Claim 6 (depends on 1)

The lead identification system of claim 1, wherein the first set includes a first clip lead indicator, and the second set includes a second clip lead indicator, the first clip lead indicator being removably attachable to the first therapy delivery element, and the second clip lead indicator being removably attachable to the second therapy delivery element.

### Claim 7 (depends on 6)

The lead identification system of claim 6, comprising a clip including the first clip lead indicator and the second clip lead indicator.

### Claim 8 (depends on 6)

The lead identification system of claim 6, wherein the first clip lead indicator is removably attachable to a proximal end of the first therapy delivery element, and the second clip lead indicator is removably attachable to a proximal end of the second therapy delivery element.

### Claim 9 (depends on 1)

The lead identification system of claim 1, wherein the first set includes a first lead indicator stylet, and the second set includes a second lead indicator stylet, the first lead indicator stylet being removably insertable within a lumen of the first therapy delivery element, and the second lead indicator stylet being removably insertable within a lumen of the second therapy delivery element.

### Claim 10 (depends on 1)

The lead identification system of claim 1, wherein the first set includes a first rotating lead indicator removably attachable to the first epidural needle, and the second set includes a second rotating lead indicator removably attachable to the second epidural needle, wherein a rotational orientation of each of the first and second rotating lead indicators uniquely identifies each of the first and second therapy delivery elements, respectively.

### Claim 11 (depends on 1)

The lead identification system of claim 1, wherein the first set includes a first connector lead indicator removably attachable to the first connector of a trial device, and the second set includes a second connector lead indicator removably attachable to the second connector of the trial device, the trial device being configured to conduct trial stimulation of the first and second therapy delivery elements.

### Claim 12 (depends on 1)

The lead identification system of claim 1, wherein the first set includes a first connector lead indicator removably attachable to the first connector of a pulse generator, and the second set includes a second connector lead indicator removably attachable to the second connector of the pulse generator.

### Claim 13 (depends on 1)

The lead identification system of claim 1, wherein the first set includes a first anchor lead indicator of a first lead anchor, and the second set includes a second anchor lead indicator of a second lead anchor.

### Claim 14 (depends on 1)

The lead identification system of claim 1, comprising a third set of third lead indicators, each of the third lead indicators configured to removably attach to at least one of a third therapy delivery element, a third epidural needle, or a third connector to uniquely identify at least one of the third therapy delivery element, the third epidural needle, or the third connector during implantation of the third therapy delivery element in the patient.

### Claim 15

A neurostimulation system, comprising:
at least a first therapy delivery element and a second therapy delivery element, each of the first and second therapy delivery elements including a proximal end with a plurality of electrical contacts and a distal end with a plurality of electrodes electrically coupled to the electrical contacts, the first therapy delivery element being configured to be implanted using a first epidural needle, and the second therapy delivery element being configured to be implanted using a second epidural needle;
a pulse generator including at least a first connector and a second connector, the first and second connectors being configured to electrically couple electrical contacts of the proximal ends of the first and second therapy delivery elements, respectively; and
a lead identification system including:
a first set of first lead indicators, each of the first lead indicators configured to removably attach to at least one of the first therapy delivery element, the first epidural needle, or the first connector to uniquely identify at least one of the first therapy delivery element, the first epidural needle, or the first connector during implantation of the first therapy delivery element in a patient; and
a second set of second lead indicators, each of the second lead indicators configured to removably attach to at least one of the second therapy delivery element, the second epidural needle, or the second connector to uniquely identify at least one of the second therapy delivery element, the second epidural needle, or the second connector during implantation of the second therapy delivery element in the patient.

### Claim 16 (depends on 15)

The neurostimulation system of claim 15, wherein each of the first lead indicators of the first set includes a first characteristic and each of the second lead indicators of the second set includes a second characteristic, the first characteristic being different from the second characteristic.

### Claim 17 (depends on 16)

The neurostimulation system of claim 16, wherein the first characteristic includes at least one of a first color, a first tactile characteristic, or a first alpha-numeric character, and the second characteristic includes at least one of a second color, a second tactile characteristic, or a second alpha-numeric character.

### Claim 18 (depends on 15)

The neurostimulation system of claim 15, wherein the first set includes a first needle lead indicator, and the second set includes a second needle lead indicator, the first needle lead indicator being removably attachable to the first epidural needle, and the second needle lead indicator being removably attachable to the second epidural needle.

### Claim 19 (depends on 15)

The neurostimulation system of claim 15, wherein the first set includes a first clip lead indicator, and the second set includes a second clip lead indicator, the first clip lead indicator being removably attachable to the first therapy delivery element, and the second clip lead indicator being removably attachable to the second therapy delivery element.

### Claim 20 (depends on 15)

The neurostimulation system of claim 15, wherein the first set includes a first lead indicator stylet, and the second set includes a second lead indicator stylet, the first lead indicator stylet being removably insertable within a lumen of the first therapy delivery element, and the second lead indicator stylet being removably insertable within a lumen of the second therapy delivery element.

### Claim 21 (depends on 1)

The lead identification system of claim 1, wherein:
the first set of first lead indicators includes at least two of:
a first indicator of the first lead indicators configured to removably attach to the first therapy delivery element;
a second indicator of the first lead indicators configured to removably attach to the first epidural needle; and
a third indicator of the first lead indicators configured to removably attach to the first connector; and
the second set of first lead indicators includes at least two of:
a first indicator of the second lead indicators configured to removably attach to the second therapy delivery element;
a second indicator of the second lead indicators configured to removably attach to the second epidural needle; and
a third indicator of the second lead indicators configured to removably attach to the second connector.

### Claim 22 (depends on 15)

The neurostimulation system of claim 15, wherein:
the first set of first lead indicators includes at least two of:
a first indicator of the first lead indicators configured to removably attach to the first therapy delivery element;
a second indicator of the first lead indicators configured to removably attach to the first epidural needle; and
a third indicator of the first lead indicators configured to removably attach to the first connector; and
the second set of first lead indicators includes at least two of:
a first indicator of the second lead indicators configured to removably attach to the second therapy delivery element;
a second indicator of the second lead indicators configured to removably attach to the second epidural needle; and
a third indicator of the second lead indicators configured to removably attach to the second connector.
