Methods of therapeutically heating a vertebral body to treat back pain

• US 8,361,067 B2
• Filed: 09/12/2012
• Issued: 01/29/2013
• 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): Guiliani, Thomas
• Application Number:
  US13/612,541
• Publication Number:
  US 20130006232A1
• Time in Patent Office: 139 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 systems may include energy delivery probes and bone channeling instruments.

Claims

1. A method of therapeutically heating a vertebral body to treat 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 of said vertebral body;

inserting a cannula having a curved bore 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 probe having two electrodes within the cannula,

wherein the cannula is shaped so as to guide said energy delivery probe towards a midline of the vertebral body;

advancing a distal end of said energy delivery probe 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 probe within or proximate the treatment zone,

wherein the step of positioning the two electrodes of said energy delivery probe 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 within the inner cancellous bone region of the vertebral body sufficient to denervate the basivertebral nerve.

2. The method of claim 1, wherein the step of advancing a distal end of said energy delivery probe 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 the midline of the vertebral body.

3. The method of claim 1, wherein the step of positioning the two electrodes of said energy delivery probe 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.

4. The method of claim 1, wherein the step of positioning the two electrodes of said energy delivery probe within or proximate the treatment zone within the inner cancellous bone region comprises positioning the two electrodes of said energy delivery probe to straddle the treatment zone.

5. The method of claim 1, wherein the step of positioning the two electrodes of said energy delivery probe 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.

6. The method of claim 1, wherein the treatment zone comprises a basivertebral residence zone, and wherein the treatment zone is in a posterior section of the vertebral body.

7. The method of claim 1, wherein said energy delivery probe is a bipolar radiofrequency probe, and wherein the two electrodes comprise an active electrode at the distal tip of the bipolar radiofrequency probe and a return electrode spaced 2 mm proximal to the active electrode.

8. The method of claim 1, wherein the frequency of the radiofrequency energy is between about 400 kHz and 600 kHz.

9. The method of claim 1, wherein the radiofrequency energy has a temperature of between 80°

C. and 95°

C.

10. The method of claim 1, wherein the radiofrequency energy is sufficient to ablate the basivertebral nerve.

11. A method of therapeutically heating a vertebral body to treat back pain, comprising:

inserting two electrodes into the vertebral body, the vertebral body having an outer cortical bone region, an inner cancellous bone region, and a basivertebral nerve;

identifying a residence zone of the basivertebral nerve within the inner cancellous bone region of the vertebral body, the residence zone being located within a posterior section of the vertebral body;

positioning the two electrodes within or proximate the residence zone of the basivertebral nerve,

wherein the step of positioning the two electrodes within or proximate the residence 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

generating a heating zone between the two electrodes to heat the basivertebral nerve.

12. The method of claim 11, wherein the step of inserting two electrodes into the vertebral body comprises inserting a first energy delivery probe having a first electrode within the inner cancellous bone region and positioning a second energy delivery probe having a second electrode within the inner cancellous bone region, and wherein the heating zone is generated by current flowing between the first electrode and the second electrode.

13. The method of claim 11, wherein the step of inserting two electrodes into the vertebral body comprises inserting a single energy delivery probe comprising two electrodes within the inner cancellous bone region, and wherein the heating zone is generated by current flowing between the two electrodes.

14. The method of claim 11, wherein the heating zone is heated to a minimum temperature of at least 42°

C.

15. The method of claim 11, wherein the step of generating a heating zone between the two electrodes to heat the basivertebral nerve comprises activating the two electrodes to deliver radiofrequency energy within the inner cancellous bone region of the vertebral body sufficient to denervate the basivertebral nerve.

16. The method of claim 15, wherein the step of generating a heating zone between the two electrodes to heat the basivertebral nerve comprises activating the two electrodes to deliver radiofrequency energy within the inner cancellous bone region of the vertebral body sufficient to ablate the basivertebral nerve.

17. The method of claim 11, wherein the step of positioning the two electrodes within or proximate the residence zone within the inner cancellous bone region comprises positioning the two electrodes at a location such that a single heating treatment denervates an entire basivertebral nerve system without requiring separate downstream denervation treatments.

18. The method of claim 11, wherein the step of positioning the two electrodes within or proximate the residence zone within the inner cancellous bone region comprises positioning the two electrodes to straddle the residence zone.