Ablation of tissue within vertebral body involving internal cooling

• US 10,478,246 B2
• Filed: 10/05/2018
• Issued: 11/19/2019
• Est. Priority Date: 09/30/2002
• Status: Expired due to Term

• Current Assignee: Relievant Medsystems, Incorporated (Boston Scientific Corporation)
• Original Assignee: Relievant Medsystems, Incorporated (Boston Scientific Corporation)
• Inventors: Pellegrino, Richard, Patel, Samit, Papineau, Paula, Crombie, John S., Ryan, Thomas
• Primary Examiner(s): Giuliani, Thomas A
• Application Number:
  US16/153,234
• Publication Number:
  US 20190038344A1
• Time in Patent Office: 410 Days
• Field of Search: 606 41, 606 42, 606 49, 606 50, 606 79, 606 92, 607 99, 607102, 607116-118
• CPC Class Codes: 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
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: 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
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/148 having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
• CPC Class Codes: A61B 18/1487 Trocar-like, i.e. devices producing an enlarged transcutaneous opening
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/16 Indifferent or passive electrodes for grounding
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 18/22 the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/320069 for ablating tissue
• CPC Class Codes: A61B 2018/00017 : with gas
• CPC Class Codes: A61B 2018/00339 : Spine, e.g. intervertebral disc
• CPC Class Codes: A61B 2018/00434 : Neural system
• CPC Class Codes: A61B 2018/0044 : Spinal cord
• CPC Class Codes: A61B 2018/00565 : Bone
• CPC Class Codes: A61B 2018/00577 : Ablation
• CPC Class Codes: A61B 2018/00589 : Coagulation
• CPC Class Codes: A61B 2018/00642 : with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/0072 : Current
• CPC Class Codes: A61B 2018/00761 : Duration
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00821 : measured by a thermocouple
• CPC Class Codes: A61B 2018/126 : bipolar
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2018/1807 : using light other than laser radiation
• CPC Class Codes: A61B 2018/2005 : with beam delivery through an interstitially insertable device, e.g. needle
• CPC Class Codes: A61B 2034/301 : for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes
• CPC Class Codes: A61B 2090/374 : NMR or MRI
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61N 1/0551 : Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/06 : for high-frequency therapy
• CPC Class Codes: A61N 5/00 : Radiation therapy ultrasound therapy A61N7/00; devices or apparatus applicable to both therapy and diagnosis A61B6/00
• CPC Class Codes: 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

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

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.

2. 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.

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

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

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

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

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.

8. 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.

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

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

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

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

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

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.

15. 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.

16. 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.

17. 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.

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

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

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