Methods of treating back pain

• US 8,419,731 B2
• Filed: 09/13/2012
• Issued: 04/16/2013
• 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, Papineau, Paula, Crombie, John S., Patel, Samit, Ryan, Thomas
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): GIULIANI, THOMAS ANTHONY
• Application Number:
  US13/615,001
• Publication Number:
  US 20130012935A1
• Time in Patent Office: 215 Days
• Field of Search: 606/32, 606/41, 607 98-100, 607/113, 607/115, 607/117
• US Class Current: 606/41
• 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 for prostheses A61F2210/0014
• 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 treating back pain, comprising:

identifying a vertebral body for treatment, said vertebral body comprising an outer cortical bone region and an inner cancellous bone region, and a basivertebral nerve extending within the inner cancellous bone region;

identifying a treatment zone within a posterior section of the vertebral body;

inserting a curved stylet having a sharpened distal tip within a lumen of a curved cannula and advancing the curved stylet beyond an open distal end of the curved cannula;

inserting the curved cannula through the outer cortical bone region of the vertebral body and into the inner cancellous bone region of the vertebral body, thereby forming a curved path within the inner cancellous bone region toward the treatment zone;

removing the curved stylet from the curved cannula;

inserting a channeling stylet within the lumen of the curved cannula and advancing the channeling stylet beyond the open distal end of the curved cannula, wherein the channeling stylet is flexibly deformable to navigate the curved cannula yet rigid enough to retain a straight form upon exiting the open distal end of the curved cannula;

creating a linear path beyond the curved path toward the treatment zone by advancing a distal end of the channeling stylet beyond the curved path;

removing the channeling stylet;

inserting a neuromodulation device within the curved cannula,

wherein a distal portion of the curved cannula is shaped so as to guide a distal end of said neuromodulation device towards a midline of the vertebral body;

advancing the distal end of said neuromodulation device out of a distal opening of said cannula and into the inner cancellous bone region of the vertebral body;

positioning the distal end of said neuromodulation device within the treatment zone of the vertebral body; and

effecting modulation of the basivertebral nerve using the neuromodulation device.

2. The method of claim 1, wherein said modulation comprises chemical ablation of the basivertebral nerve.

3. The method of claim 1, wherein said modulation comprises radiofrequency ablation of the basivertebral nerve.

4. The method of claim 1, wherein the neuromodulation device is an energy delivery probe.

5. The method of claim 4, wherein the energy delivery probe is a radiofrequency delivery probe having at least one electrode at the distal end of the radiofrequency probe, and wherein effecting modulation of the basivertebral nerve comprises activating the at least one electrode to deliver radiofrequency energy sufficient to modulate the basivertebral nerve.

6. The method of claim 5, wherein said at least one electrode comprises an active electrode, and wherein said RF delivery probe further comprises a return electrode.

7. The method of claim 6, wherein the active electrode is a tip electrode and wherein the return electrode is a ring electrode spaced 2 mm from a proximal end of the active electrode.

8. The method of claim 5, wherein said modulation comprises denervation of the basivertebral nerve.

9. The method of claim 5, wherein said modulation comprises ablation of the basivertebral nerve.

10. The method of claim 5, wherein the energy is configured to generate a temperature of between 80°

C. and 95°

C. at the treatment zone.

11. The method of claim 4, wherein the energy delivery probe is a microwave energy delivery device, and wherein effecting modulation of the basivertebral nerve comprises effecting delivery of microwave energy sufficient to modulate the basivertebral nerve.

12. A method of treating back pain, comprising:

identifying a vertebral body for treatment, said vertebral body comprising an outer cortical bone region and an inner cancellous bone region, and a basivertebral nerve extending from the outer cortical bone region to within the inner cancellous bone region;

identifying a treatment zone within the inner cancellous bone region within a posterior section of the vertebral body;

inserting an energy delivery probe within the treatment zone,

wherein the energy delivery probe has two electrodes at a distal portion of the energy delivery probe;

positioning the two electrodes of said energy delivery probe proximate or within the treatment zone of the vertebral body;

positioning a first electrode of the two electrodes on a first side of the vertebral body and positioning a second electrode of the two electrodes on a second side of the vertebral body; and

thermally inducing modulation of the basivertebral nerve by generating current between the two electrodes.

13. The method of claim 12, wherein the energy delivery probe comprises a bipolar radiofrequency delivery probe, and wherein one of the two electrodes comprises an active electrode and the other of the two electrodes comprises a return electrode.

14. The method of claim 13, wherein the step of thermally inducing modulation of a function of the basivertebral nerve with the energy delivery probe comprises activating the active electrode to generate a current between the active electrode and the return electrode to heat the treatment zone.

15. The method of claim 12, wherein said modulation comprises denervation of the basivertebral nerve.

16. The method of claim 12, wherein said modulation comprises ablation of the basivertebral nerve.

17. The method of claim 12, further comprising generating a curved path within the inner cancellous bone region towards a midline of the vertebral body with a cannula having a pre-curved distal section to facilitate access to the posterior section of the vertebral body by insertion through a pedicle, and inserting the energy delivery probe within the curved path through the cannula.