VERTEBRAL TREATMENT

• US 20130324996A1
• Filed: 06/21/2013
• Published: 12/05/2013
• Est. Priority Date: 09/30/2002
• 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
• Granted Patent: US 8,992,523 B2
• Time in Patent Office: Days
• US Class Current: 606/33
• 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. (canceled)

2. A method of heating a vertebral body, comprising:

identifying a vertebral body for treatment, said vertebral body comprising an outer cortical bone region and an inner cancellous bone region, and at least a portion of a basivertebral nerve to within the inner cancellous bone region;

identifying a treatment zone within the inner cancellous bone region of said vertebral body corresponding to a likely location of the portion of the basivertebral nerve;

inserting a cannula through the outer cortical bone region of the vertebral body and into the inner cancellous bone region of the vertebral body;

inserting a flexible radiofrequency energy delivery device having two electrodes within the cannula,

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

positioning the two electrodes of said energy delivery device within or proximate the treatment zone,

wherein the step of positioning the two electrodes of said energy delivery device within or proximate the treatment zone comprises 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

activating the two electrodes to deliver radiofrequency energy to the treatment zone within the inner cancellous bone region of the vertebral body sufficient to modulate the basivertebral nerve.

3. The method of claim 2, wherein the step of advancing a distal end of said energy delivery device out of a distal opening of said cannula and into the inner cancellous bone region of the vertebral body comprises advancing the two electrodes until they are located substantially at a midline of the vertebral body.

4. The method of claim 2, wherein the step of positioning the two electrodes of said energy delivery device within or proximate the treatment zone within the inner cancellous bone region comprises positioning the electrodes at a location such that a single treatment denervates each of the branches downstream of a basivertebral nerve junction.

5. The method of claim 2, wherein the step of positioning the two electrodes of said energy delivery device within or proximate the treatment zone within the inner cancellous bone region comprises positioning the two electrodes of said energy delivery device to straddle the treatment zone.

6. The method of claim 2, wherein the step of positioning the two electrodes of said energy delivery device within or proximate the treatment zone within the inner cancellous bone region comprises positioning the two electrodes at positions within the inner cancellous bone region between a basivertebral nerve junction and the outer cortical bone region.

7. The method of claim 2, wherein the treatment zone comprises a basivertebral residence zone, and wherein the treatment zone is in a posterior section of the vertebral body.

8. The method of claim 2, wherein said energy delivery device is a bipolar radiofrequency energy delivery probe, and wherein the two electrodes comprise an active electrode at the distal tip of the bipolar radiofrequency energy delivery probe and a return electrode spaced proximal to the active electrode.

9. The method of claim 2, wherein the frequency of the radiofrequency energy is between 400 kHz and 600 kHz.

10. The method of claim 2, wherein the radiofrequency energy has a temperature of between 80°

C. and 95°

C.

11. The method of claim 2, wherein the radiofrequency energy is sufficient to ablate the basivertebral nerve.

12. A method of heating a vertebral body, comprising:

providing a heating system, said system comprising a cannula and an energy delivery device having two electrodes, said system for;

(i) identifying a vertebral body for treatment, said vertebral body comprising an outer cortical bone region and an inner cancellous bone region, and at least a portion of a basivertebral nerve to within the inner cancellous bone region;

(ii) identifying a treatment zone within the inner cancellous bone region of said vertebral body corresponding to a likely location of the portion of the basivertebral nerve;

(iii) inserting the cannula through the outer cortical bone region of the vertebral body and into the inner cancellous bone region of the vertebral body;

(iv) inserting the energy delivery device within the cannula,

(v) advancing a distal end of the delivery device out of a distal opening of the cannula and into the inner cancellous bone region of the vertebral body;

(vi) positioning the two electrodes of the energy delivery device within or proximate the treatment zone,

wherein the step of positioning the two electrodes of said energy delivery device within or proximate the treatment zone comprises 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

(vii) activating the two electrodes to generate heat within the treatment zone within the inner cancellous bone region of the vertebral body sufficient to modulate the basivertebral nerve.

13. The method of claim 12, wherein the treatment zone comprises a basivertebral residence zone, and wherein the treatment zone is in a posterior section of the vertebral body.

14. The method of claim 12, wherein said energy delivery device is a bipolar radiofrequency energy delivery probe.

15. The method of claim 14, wherein the two electrodes comprise an active electrode at the distal tip of the bipolar radiofrequency energy delivery probe and a return electrode spaced proximal to the active electrode.

16. The method of claim 15, wherein the return electrode comprises a cylindrical electrode.

17. The method of claim 12, wherein the heat is generated by radiofrequency energy having a frequency between 400 kHz and 600 kHz.

18. The method of claim 12, wherein the heat generated by the energy delivery device has a temperature of between 80°

C. and 95°

C.

19. The method of claim 12, wherein the energy delivery device is flexible.

20. The method of claim 12, wherein the energy delivery system is configured for generating heat sufficient to permanently ablate the basivertebral nerve.

21. The method of claim 12, wherein the cannula comprises a curved bore.