# US 2018/0021569 A1 · Systems and methods for making and using an electrical stimulation system for stimulation of dorsal root ganglia

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- Number: US 2018/0021569 A1
- Document ID: US20180021569A1
- Status: Published application
- Kind: A1
- Application number: 15/656,698
- Filed: 2017-07-21
- Published: 2018-01-25
- Earliest claimed: 2016-07-25
- Assignees: Boston Scientific Neuromodulation Corporation
- Applicants: Boston Scientific Neuromodulation Corporation
- Inventors: Anne Margaret Pianca
- Web page: https://patentgrep.com/patent/US20180021569A1

## CPC

- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61B 17/3417: {Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating (syringe needles A61M5/32; dilators A61M29/00)}
- A61M 25/09: Guide wires
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61B 2017/3456: {blunt}
- A61M 2025/09183: {having tools at the distal tip}
- A61N 1/0558: {Anchoring or fixation means therefor}
- A61N 1/36062: {Spinal stimulation}
- A61N 1/36071: {Pain}
- 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)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A method for implanting a lead for stimulation of a dorsal root ganglion of a patient includes advancing a distal portion of a guidewire using an introducer into an epidural space of the patient and through a foramen of the patient to a position near the dorsal root ganglion, the guidewire including an electrode in the distal portion of the guidewire; mapping a region around the dorsal root ganglion using the electrode of the guidewire to identify a lead implantation site; removing the introducer; and advancing the lead over the guidewire, with a portion of the guidewire disposed in a lumen of the lead, to position a distal portion of the lead at the lead implantation site.

## Claims

### Claim 1

A method for implanting a lead for stimulation of a dorsal root ganglion of a patient, the method comprising:
advancing a distal portion of a guidewire using an introducer into an epidural space of the patient and through a foramen of the patient to a position near the dorsal root ganglion, the guidewire comprising an electrode in the distal portion of the guidewire;
mapping a region around the dorsal root ganglion using the electrode of the guidewire to identify a lead implantation site;
removing the introducer; and
advancing the lead over the guidewire, with a portion of the guidewire disposed in a lumen of the lead, to position a distal portion of the lead at the lead implantation site.

### Claim 2 (depends on 1)

The method of claim 1, wherein advancing the distal portion of the guidewire comprises advancing the introducer and the distal portion of the guidewire through the foramen of the patient.

### Claim 3 (depends on 1)

The method of claim 1, wherein the introducer has a flat, blunt tip to facilitate penetration of scar tissue around the foramen.

### Claim 4 (depends on 1)

The method of claim 1, wherein mapping the region around the dorsal root ganglion comprises stimulation of patient tissue using the electrode of the guidewire.

### Claim 5 (depends on 1)

The method of claim 1, wherein mapping the region around the dorsal root ganglion comprises receiving electrical signals from patient tissue using the electrode of the guidewire.

### Claim 6 (depends on 1)

The method of claim 1, wherein the introducer is no more than 20 gauge.

### Claim 7 (depends on 1)

The method of claim 1, further comprising repositioning the distal portion of the guidewire to another site relative to the dorsal root ganglion.

### Claim 8 (depends on 1)

The method of claim 1, wherein the introducer comprises a reinforced mesh to reduce kinking.

### Claim 9

A method for implanting a lead for stimulation of a dorsal root ganglion of a patient, the method comprising:
advancing a distal portion of a guidewire through an epidural space of the patient and through a foramen of the patient to a position near the dorsal root ganglion, the guidewire comprising an electrode in the distal portion of the guidewire;
mapping a portion of the patient tissue adjacent the distal portion of the guidewire using the electrode;
repositioning the distal portion of the guidewire to a lead implantation site relative to the dorsal root ganglion and mapping an additional portion of the patient tissue using the electrode; and
advancing the lead over the guidewire, with a portion of the guidewire disposed in a lumen of the lead, to position a distal portion of the lead at the lead implantation site.

### Claim 10 (depends on 9)

The method of claim 9, wherein advancing the distal portion of the guidewire comprises advancing the guidewire through an introducer.

### Claim 11 (depends on 10)

The method of claim 10, wherein advancing the distal portion of the guidewire further comprises advancing the introducer and the distal portion of the guidewire through the foramen of the patient.

### Claim 12 (depends on 9)

The method of claim 9, wherein the introducer has a flat, blunt tip to facilitate penetration of scar tissue around the foramen.

### Claim 13 (depends on 9)

The method of claim 9, wherein the introducer is no more than 20 gauge.

### Claim 14 (depends on 9)

The method of claim 9, wherein mapping the portion of the patient tissue comprises stimulating patient tissue using the electrode of the guidewire.

### Claim 15 (depends on 9)

The method of claim 9, wherein mapping the portion of the patient tissue comprises receiving electrical signals from patient tissue using the electrode of the guidewire.

### Claim 16 (depends on 9)

The method of claim 9, wherein the introducer comprises a reinforced mesh to reduce kinking.

### Claim 17

A kit for implanting a lead for stimulation of a dorsal root ganglion of a patient, the kit comprising:
a guidewire with an electrode disposed at a distal end of the guidewire;
an introducer having a lumen for receiving the guidewire; and
a lead comprising a lead body and a plurality of electrodes disposed along a distal end of the lead body, the lead body defining a central lumen for receiving the guidewire.

### Claim 18 (depends on 17)

The kit of claim 17, wherein the introducer has a blunt tip for penetrating scar tissue.

### Claim 19 (depends on 17)

The kit of claim 17, wherein the introducer is no more than 20 gauge.

### Claim 20 (depends on 17)

The kit of claim 17, wherein the introducer comprises a reinforced mesh to reduce kinking.
