Radiofrequency ablation of tissue within a vertebral body

• US 10,588,691 B2
• Filed: 10/05/2018
• Issued: 03/17/2020
• Est. Priority Date: 09/12/2012
• Status: Active Grant

• Current Assignee: Relievant Medsystems, Incorporated (Boston Scientific Corporation)
• Original Assignee: Relievant Medsystems, Incorporated (Boston Scientific Corporation)
• Inventors: Pellegrino, Richard, Papineau, Paula, Crombie, John S., Patel, Samit, Ryan, Thomas
• Primary Examiner(s): Giuliani, Thomas A
• Application Number:
  US16/153,242
• Publication Number:
  US 20190038345A1
• Time in Patent Office: 529 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 18/1206 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 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 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, 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;

removing the stylet from the cannula;

inserting a bipolar radiofrequency device through the cannula to a treatment zone along a curved path within the vertebral body using image guidance,

wherein the bipolar radiofrequency device comprises two electrodes and a sharp distal tip configured to penetrate bone tissue,

wherein at least one of the two electrodes is configured to be deployed out of a shaft of the bipolar radiofrequency device,

wherein at least a distal portion of the bipolar radiofrequency device is selectively deflectable to facilitate positioning of the two electrodes within the treatment zone using image guidance, and

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 bipolar radiofrequency device for a duration of time sufficient to ablate tissue at the treatment zone;

wherein the tissue comprises at least a portion of a basivertebral nerve within the vertebral body,

wherein the bipolar radiofrequency device comprises an imaging device and a temperature sensor,

wherein treatment parameters are adjusted to form a heating zone of a specific size and shape, and

wherein the adjustment is based on temperature.

2. The method of claim 1:

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 vertebral body comprises a tumor.

4. The method of claim 1, further comprising delivering a therapeutic agent to the treatment zone.

5. The method of claim 1, further comprising delivering bone cement to the treatment zone.

6. The method of claim 1, wherein the duration of time is between 5 minutes and 15 minutes.

7. The method of claim 1, wherein the imaging device is a camera or an ultrasound device.

8. A method of accessing and ablating tissue within a vertebral body, 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 bipolar radiofrequency device through the cannula to a treatment zone along a curved path within the vertebral body using image guidance,

wherein the bipolar radiofrequency device comprises two electrodes and a sharp distal tip configured to penetrate bone tissue,

wherein at least one of the two electrodes is configured to be deployed out of a shaft of the bipolar radiofrequency device,

wherein at least a distal portion of the bipolar radiofrequency device is selectively deflectable to facilitate positioning of the two electrodes within the treatment zone using image guidance, and

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 bipolar radiofrequency device for a duration of time sufficient to ablate tissue at the treatment zone;

wherein the tissue comprises at least a portion of a basivertebral nerve within the vertebral body,

wherein the bipolar radiofrequency device comprises a diagnostic device configured to facilitate imaging and a temperature sensor, and

wherein treatment parameters are adjusted to form a heating zone of a specific size and shape.

9. The method of claim 8:

wherein the temperature sensor is coupled to a temperature monitor, and

wherein the duration of time is between 5 minutes and 15 minutes.

10. The method of claim 8, wherein the vertebral body comprises a tumor.

11. The method of claim 8, further comprising delivering a therapeutic agent to the treatment zone.

12. The method of claim 8, further comprising delivering bone cement to the treatment zone.

13. The method of claim 8, wherein the diagnostic device configured to facilitate imaging comprises one or more ultrasound elements or cameras.

14. A method of accessing and ablating tissue within a vertebral body, 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 radiofrequency probe through the cannula to a treatment zone along a curved path within the vertebral body using image guidance, the radiofrequency probe comprising at least one electrode and a sharp distal tip configured to penetrate bone tissue,

wherein the at least one electrode is configured to be deployed out of a shaft of the radiofrequency probe,

wherein at least a distal portion of the radiofrequency probe is selectively deflectable to facilitate positioning of the at least one electrode within the treatment zone using image guidance, and

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 radiofrequency probe for a duration of time sufficient to ablate tissue at the treatment zone,

wherein the tissue comprises at least a portion of a basivertebral nerve within the vertebral body,

wherein the radiofrequency probe comprises diagnostic devices configured to provide diagnostic information in connection with treatment of the tissue,

wherein the diagnostic devices comprise at least one temperature sensor and at least one diagnostic device configured to facilitate imaging, and

wherein treatment parameters are adjusted to form a heating zone of a specific size and shape.

15. The method of claim 14:

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, further comprising delivering a therapeutic agent to the treatment zone.

17. The method of claim 14, further comprising delivering bone cement to the treatment zone.

18. The method of claim 14, wherein the at least one diagnostic device configured to facilitate imaging comprises one or more ultrasound elements.

19. The method of claim 14, wherein advancing the stylet and the cannula within the vertebral body is performed through a pedicle of the vertebral body.

20. The method of claim 14, wherein the at least one diagnostic device configured to facilitate imaging comprises one or more cameras.