# US 10,245,435 B1 · Wireless neural stimulator implantation

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- Number: US 10,245,435 B1
- Document ID: US10245435B1
- Status: Granted
- Kind: B1
- Application number: 14/590,524
- Filed: 2015-01-06
- Granted: 2019-04-02
- Earliest claimed: 2014-01-06
- Assignees: Stimwave Technologies Incorporated
- Applicants: Micron Devices LLC
- Inventors: Laura Tyler Perryman; Benjamin Speck
- Web page: https://patentgrep.com/patent/US10245435B1

## CPC

- A61N 1/3756: {Casings with electrodes thereon, e.g. leadless stimulators}
- A61B 17/3401: {Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia}
- A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61M 25/0606: {"Over-the-needle" catheter assemblies, e.g. I.V. catheters}
- A61N 1/36071: {Pain}
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61B 2090/376: {using X-rays, e.g. fluoroscopy}
- A61B 2090/378: {using ultrasound}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61N 1/37229: {Shape or location of the implanted or external antenna}
- A61N 1/3787: {from an external energy source}
- 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

Some implementations provide a method for implanting a neurostimulator system that includes: placing an introducer through an incision site on a patient into an epidural space of the patient, the introducer including a sheath and the patient having a primary area of pain; placing a neurostimulator system through the introducer into the epidural space of the patient, the neurostimulator system comprising an enclosure housing at least one pair of electrodes and at least one passive antenna; advancing the neurostimulator system through the epidural space such that the electrodes are placed at a targeted tissue of the patient; removing the introducer sheath from the epidural space of the patient; adjusting the neurostimulator system enclosure to leave a customized length of the device body enclosure in the epidural space; and anchoring the customized length of the neurostimulator system enclosure in tissue of the patient.

## Claims

### Claim 1

A method for implanting a neurostimulator system, comprising:
inserting an introducer sheath and a needle, carried by the introducer sheath, through an incision site on a patient and into an epidural space of the patient;
withdrawing the needle through the introducer sheath and out of the patient;
after withdrawing the needle out of the patient, inserting the neurostimulator system through the introducer sheath and into the epidural space of the patient, the neurostimulator system comprising an enclosure housing electrodes and at least one passive antenna, the at least one passive antenna configured to receive, via electric radiative coupling, electrical energy and waveform parameters from an antenna located exteriorly to the patient, and the electrodes configured to generate electrical waveforms from the electrical energy and the waveform parameters received at the at least one passive antenna;
advancing the neurostimulator system through the epidural space until the electrodes are positioned adjacent a targeted tissue of the patient so that the electrodes can apply the electrical waveforms to render pain relief therapy to the targeted tissue and in a manner such that a proximal portion of the enclosure remains external to the patient;
removing the introducer sheath from the epidural space of the patient;
removing the proximal portion of the enclosure from the neurostimulator system to leave an implanted portion of the enclosure remaining in the epidural space such that the implanted portion of the enclosure has a customized length that is specific to the patient;
after removing the proximal portion of the enclosure, attaching a cap carrying a radiopaque marker to the implanted portion of the enclosure; and
after attaching the cap to implanted portion of the enclosure, further attaching the cap to a connective tissue at the incision site to anchor the implanted portion of the enclosure to the patient.

### Claim 2 (depends on 1)

The method of claim 1, wherein removing the proximal portion of the enclosure comprises cutting the enclosure such that the implanted portion, having the customized length, fits between the incision site on the patient and the targeted tissue of the patient.

### Claim 3 (depends on 1)

The method of claim 1, further comprising: positioning the enclosure such that the pain relief therapy provided by the electrodes covers an area that substantially overlaps a primary pain area of the patient.

### Claim 4 (depends on 3)

The method of claim 3, further comprising: adjusting the waveform parameters to improve the pain relief therapy provided by the electrodes of the neurostimulator system.

### Claim 5 (depends on 1)

The method of claim 1, further comprising: inserting an additional neurostimulator system through the introducer sheath and into the epidural space of the patient, the additional neurostimulator system comprising an additional enclosure housing additional electrodes and at least one additional passive antenna, the at least one additional passive antenna configured to receive, via electric radiative coupling, electrical energy and waveform parameters from the antenna located exteriorly to the patient.

### Claim 6 (depends on 5)

The method of claim 5, further comprising: advancing the additional neurostimulator system through the epidural space until the additional electrodes are located at a position that is spaced apart from the targeted tissue so that the additional electrodes can apply additional electrical waveforms to enhance the pain relief therapy.

### Claim 7 (depends on 5)

The method of claim 5, further comprising: advancing the additional neurostimulator system through the epidural space until the additional electrodes are positioned near the targeted tissue of the patient so that the additional electrodes can apply additional electrical waveforms to the targeted tissue to enhance the pain relief therapy.

### Claim 8 (depends on 1)

The method of claim 1, further comprising: using X-Ray fluoroscopy to guide movement of the neurostimulator system through the introducer sheath and into the epidural space.

### Claim 9 (depends on 1)

The method of claim 1, further comprising: using X-Ray fluoroscopy to guide advancement of the neurostimulator system through the epidural space.

### Claim 10 (depends on 1)

The method of claim 1, further comprising: using ultrasound sonography to guide movement of the neurostimulator system through the introducer sheath and into the epidural space.

### Claim 11 (depends on 1)

The method of claim 1, further comprising: using ultrasound sonography to guide advancement of the neurostimulator system through the epidural space.

### Claim 12 (depends on 1)

The method of claim 1, further comprising:
using fluoroscopy to locate the radiopaque marker before explanting the implanted portion of the enclosure that has been anchored to the patient.

### Claim 13 (depends on 1)

The method of claim 1, further comprising:
using ultrasound sonography to locate the radiopaque marker before explanting the implanted portion of the enclosure that has been anchored to the patient.

### Claim 14 (depends on 1)

The method of claim 1, further comprising: inserting a guide wire through the introducer sheath and advancing the guide wire into the epidural space.

### Claim 15 (depends on 14)

The method of claim 14, further comprising: advancing the guide wire to no more than approximately 3 cm past a tip of the introducer sheath.

### Claim 16 (depends on 15)

The method of claim 15, further comprising: advancing the neurostimulator system by gliding the neurostimulator system within the introducer sheath and into the epidural space.

### Claim 17 (depends on 1)

The method of claim 1, wherein anchoring the implanted portion of the enclosure comprises suturing the cap to the connective tissue at the incision site.

### Claim 18 (depends on 1)

The method of claim 1, wherein the implanted portion of the enclosure extends from a first end that is lateral to the midline of the patient and adjacent the targeted tissue to a second end that is under the incision site without pointing to the incision site through which the introducer sheath was placed.

### Claim 19 (depends on 1)

The method of claim 1, wherein the needle is configured to block the electrical energy from the antenna located exteriorly to the patient.

### Claim 20 (depends on 1)

The method of claim 1, wherein the implanted portion of the enclosure has a length of at least 2 cm for accommodating the cap.

### Claim 21 (depends on 1)

The method of claim 1, wherein the incision site has a length in a range of 0.5 cm to 4.5 cm for allowing passage of the introducer sheath.
