# US 10,478,246 B2 · Ablation of tissue within vertebral body involving internal cooling

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- Number: US 10,478,246 B2
- Document ID: US10478246B2
- Status: Granted
- Kind: B2
- Application number: 16/153,234
- Filed: 2018-10-05
- Published: 2019-02-07
- Granted: 2019-11-19
- Earliest claimed: 2012-09-12
- Assignees: Relievant Medsystems, Inc.
- Applicants: Relievant Medsystems, Inc.
- Inventors: Richard Pellegrino; Samit Patel; Paula Papineau; John S. Crombie; Thomas Ryan
- Web page: https://patentgrep.com/patent/US10478246B2

## CPC

- A61B 18/1487: {Trocar-like, i.e. devices producing an enlarged transcutaneous opening}
- A61B 17/3472: {for bones, e.g. intraosseus injections}
- A61B 17/8819: {characterised by the introducer proximal part, e.g. cannula handle, or by parts which are inserted inside each other, e.g. stylet and cannula (A61B17/8825 takes precedence)}
- A61B 18/082: {Probes or electrodes therefor}
- A61B 18/12: by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B 18/1206: {Generators therefor}
- A61B 18/148: {having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 18/18: by applying electromagnetic radiation, e.g. microwaves
- A61N 1/06: for high-frequency therapy
- A61N 5/00: Radiation therapy (ultrasound therapy A61N7/00; devices or apparatus applicable to both therapy and diagnosis A61B6/00)
- A61B 17/320068: {using mechanical vibrations, e.g. ultrasonic (A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745)}
- A61B 17/8805: {for introducing fluid filler into bone or extracting it (A61B17/7097, A61B17/8833 take precedence)}
- A61B 18/02: by cooling, e.g. cryogenic techniques
- A61B 18/16: Indifferent or passive electrodes for grounding
- A61B 18/1815: {using microwaves}
- A61B 18/20: using laser
- A61B 18/22: the beam being directed along or through a flexible conduit, e.g. an optical fibre; {Couplings or} hand-pieces therefor
- A61B 2017/00261: {Discectomy}
- A61B 2017/00331: {with preformed bends}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/320069: {for ablating tissue}
- A61B 2018/00017: {with gas}
- A61B 2018/00339: {Spine, e.g. intervertebral disc}
- A61B 2018/00434: {Neural system}
- A61B 2018/0044: {Spinal cord}
- A61B 2018/00565: {Bone}
- A61B 2018/00577: {Ablation}
- A61B 2018/00589: {Coagulation}
- A61B 2018/00642: {with feedback, i.e. closed loop control}
- A61B 2018/0072: {Current}
- A61B 2018/00761: {Duration}
- A61B 2018/00791: {Temperature}
- A61B 2018/00821: {measured by a thermocouple}
- A61B 2018/126: {bipolar}
- A61B 2018/1425: {Needle}
- A61B 2018/1807: {using light other than laser radiation}
- A61B 2018/2005: {with beam delivery through an interstitially insertable device, e.g. needle}
- A61B 2034/301: {for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes}
- A61B 2090/374: {NMR or MRI}
- A61B 2218/002: Irrigation
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61N 7/00: Ultrasound therapy (lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 {; using ultrasound for introducing media into the body A61M37/0092})
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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

Methods and systems for modulating intraosseous nerves (e.g., nerves within bone) are provided. For example, the methods and systems described herein may be used to modulate (e.g., denervate, ablate) basivertebral nerves within vertebrae. The modulation of the basivertebral nerves may facilitate treatment of chronic back pain. The modulation may be performed by a neuromodulation device (e.g., an energy delivery device).

## Claims

### Claim 1

A method of accessing and ablating tissue within a vertebral body involving internal cooling, the method comprising:
inserting a stylet within a cannula;
percutaneously inserting the stylet and the cannula through skin of a patient;
advancing the stylet and the cannula within the vertebral body using a transpedicular approach through a first pedicle using real time image guidance;
removing the stylet from the cannula;
inserting a channeling tool through the cannula to create a working channel beyond a path formed by the stylet within the vertebral body using real time image guidance;
removing the channeling tool from the cannula;
identifying a treatment zone within the vertebral body to include an anterior-posterior distance;
inserting a first radiofrequency probe through the cannula to the treatment zone within the vertebral body using real time image guidance,
wherein the first radiofrequency probe comprises a bipolar probe having a first two electrodes, wherein a return electrode of the first two electrodes is spaced proximally from an active electrode of the first two electrodes,
inserting a second radiofrequency probe within the vertebral body through a second pedicle and to the treatment zone using real time image guidance,
wherein the second radiofrequency probe comprises a bipolar probe having a second two electrodes, wherein a return electrode of the second two electrodes is spaced proximally from an active electrode of the second two electrodes;
wherein the first and second radiofrequency probes are coupled to a single generator,
causing energy within a frequency range between 400 kHz and 600 kHz to be delivered to the treatment zone within the vertebral body using the first and second radiofrequency probes for a duration of time sufficient to ablate tissue at the treatment zone,
wherein the tissue comprises at least one of a basivertebral nerve and a tumor,
wherein the first radiofrequency probe comprises one or more diagnostic devices configured to provide diagnostic information in connection with treatment of the tissue; and
causing cooling fluid to circulate through one or more lumens of at least one of the first and second radiofrequency probes to provide cooling to the treatment zone.

### Claim 2 (depends on 1)

The method of claim 1:
wherein the first radiofrequency probe comprises a temperature sensor,
wherein the temperature sensor is coupled to a temperature monitor, and
wherein the duration of time is between 5 minutes and 15 minutes.

### Claim 3 (depends on 1)

The method of claim 1, wherein the tissue comprises a basivertebral nerve.

### Claim 4 (depends on 1)

The method of claim 1, further comprising adjusting treatment parameters to form a heating zone of a specific size and shape.

### Claim 5 (depends on 1)

The method of claim 1, further comprising measuring temperature of the treatment zone with a temperature sensor.

### Claim 6 (depends on 1)

The method of claim 1, further comprising delivering bone cement to the vertebral body.

### Claim 7

A method of accessing and ablating tissue within a vertebral body involving internal cooling, the method comprising:
inserting a stylet within a cannula;
percutaneously inserting the stylet and the cannula through skin of a patient;
advancing the stylet and the cannula within the vertebral body;
removing the stylet from the cannula;
inserting a channeling tool through the cannula to create a working channel beyond a path formed by the stylet within the vertebral body;
removing the channeling tool from the cannula;
inserting a first radiofrequency probe through the cannula to a treatment zone within the vertebral body on a first side of the vertebral body, wherein the first radiofrequency probe comprises a first plurality of electrodes, wherein the first plurality of electrodes comprises an active tip electrode positioned at a distal tip of the first radiofrequency probe and a return ring electrode spaced proximally from the active electrode with insulation material disposed between the active tip electrode and the return ring electrode of the first plurality of electrodes;
inserting a second radiofrequency probe to the treatment zone within the vertebral body on a second side of the vertebral body, wherein the second radiofrequency probe comprises a second plurality of electrodes, wherein the second plurality of electrodes comprises an active tip electrode positioned at a distal tip of the second radiofrequency probe and a return ring electrode spaced proximally from the active electrode with insulation material disposed between the active tip electrode and the return ring electrode of the second plurality of electrodes;
causing energy within a frequency range between 400 kHz and 600 kHz to be delivered to the treatment zone within the vertebral body using the first and second radiofrequency probes for a duration of time sufficient to ablate tissue at the treatment zone,
wherein the tissue comprises at least one of a basivertebral nerve and a tumor; and
causing cooling fluid to circulate through one or more lumens of at least one of the first and second radiofrequency probes to provide cooling to the treatment zone.

### Claim 8 (depends on 7)

The method of claim 7:
wherein the first radiofrequency probe comprises a temperature sensor,
wherein the temperature sensor is coupled to a temperature monitor, and
wherein the duration of time is between 5 minutes and 15 minutes.

### Claim 9 (depends on 7)

The method of claim 7, further comprising adjusting treatment parameters to form a heating zone of a specific size and shape.

### Claim 10 (depends on 7)

The method of claim 7, wherein the tissue comprises a basivertebral nerve.

### Claim 11 (depends on 7)

The method of claim 7, wherein the tissue comprises a tumor.

### Claim 12 (depends on 7)

The method of claim 7, further comprising measuring temperature of the treatment zone with a temperature sensor.

### Claim 13 (depends on 7)

The method of claim 7, further comprising delivering bone cement to the vertebral body.

### Claim 14

A method of accessing and heating tissue within a vertebral body involving internal cooling, the method comprising:
inserting a stylet within a cannula;
percutaneously inserting the stylet and the cannula through skin of a patient;
advancing the stylet and the cannula within the vertebral body;
removing the stylet from the cannula;
inserting a channeling tool through the cannula to create a working channel beyond a path formed by the stylet within the vertebral body;
removing the channeling tool from the cannula;
inserting a first radiofrequency probe through the cannula to a treatment zone within the vertebral body on a first side of the vertebral body, wherein the first radiofrequency probe comprises a first plurality of electrodes, wherein the plurality of electrodes comprises an active tip electrode positioned at a distal tip of the first radiofrequency probe and a return ring electrode spaced proximally from the active tip electrode with insulation material disposed between the active tip electrode and the return ring electrode;
inserting a second radiofrequency probe to the treatment zone within the vertebral body on a second side of the vertebral body, wherein the second radiofrequency probe comprises a second plurality of electrodes, wherein the second plurality of electrodes comprises an active electrode positioned at a distal tip of the second radiofrequency probe and a return electrode spaced proximally from the active electrode;
causing energy within a frequency range between 400 kHz and 600 kHz to be delivered to the treatment zone within the vertebral body using the first and second radiofrequency probes for a duration of time sufficient to heat tissue at the treatment zone,
wherein treatment parameters are adjusted to form a heating zone of a specific size and shape,
wherein the adjustment is based on temperature,
wherein the tissue comprises at least one of a basivertebral nerve and a tumor; and
causing cooling fluid to circulate through one or more lumens of at least one of the first and second radiofrequency probes to provide cooling to the treatment zone.

### Claim 15 (depends on 14)

The method of claim 14:
wherein at least one of the first and second radiofrequency probes comprises a temperature sensor,
wherein the temperature sensor is coupled to a temperature monitor, and
wherein the duration of time is between 5 minutes and 15 minutes.

### Claim 16 (depends on 14)

The method of claim 14, wherein the first radiofrequency probe comprises one or more diagnostic devices configured to provide diagnostic information in connection with treatment of the tissue.

### Claim 17 (depends on 14)

The method of claim 14, wherein inserting the second radiofrequency probe to the treatment zone within the vertebral body comprises inserting a second cannula and a second stylet into the vertebral body; removing the second stylet from the second cannula; and inserting the second radiofrequency probe through the second cannula.

### Claim 18 (depends on 14)

The method of claim 14, wherein the first and second radiofrequency probes are inserted through separate pedicles.

### Claim 19 (depends on 14)

The method of claim 14, further comprising measuring temperature of the treatment zone with a temperature sensor.

### Claim 20 (depends on 14)

The method of claim 14, further comprising delivering bone cement to the vertebral body.
