Intraosseous nerve treatment

• US 10,111,704 B2
• Filed: 11/04/2016
• Issued: 10/30/2018
• Est. Priority Date: 09/30/2002
• Status: Expired due to Fees

• 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 ANTHONY
• Application Number:
  US15/344,284
• Publication Number:
  US 20170202613A1
• Time in Patent Office: 725 Days
• Field of Search: 606 41, 606 50, 606 79, 607 99, 607101, 607113, 607116, 607117
• 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 treating back pain from a location within a bone of a spine, comprising:

inserting a distal end portion of a radiofrequency energy delivery device having two electrodes through an outer cortical bone region of the bone and within an inner cancellous bone region of the bone,

positioning a first electrode of the two electrodes on a first side of a nerve within the bone and positioning a second electrode of the two electrodes on a second side of the nerve within the bone; and

applying radiofrequency energy to the inner cancellous bone region of the bone, thereby generating heat sufficient to ablate at least a portion of the nerve within the inner cancellous bone region of the bone.

2. The method of claim 1, wherein the nerve comprises a basivertebral nerve and wherein positioning the first electrode and positioning the second electrode comprises positioning the electrodes at a location such that a single treatment denervates each branch downstream of a junction of the basivertebral nerve.

3. The method of claim 1 wherein positioning the first electrode and positioning the second electrode comprises positioning the electrodes to straddle the nerve.

4. The method of claim 1, wherein the nerve comprises a basivertebral nerve and wherein positioning the first electrode and positioning the second electrode comprises positioning the two electrodes at positions within the inner cancellous bone region between a junction of the basivertebral nerve and the outer cortical bone region.

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

6. The method of claim 1, wherein inserting the distal end portion of the radiofrequency energy delivery device having two electrodes through the outer cortical bone region of the bone and within the inner cancellous bone region of the bone further comprises inserting an introducer through the outer cortical bone region of the bone and within the inner cancellous bone region of the bone and inserting the distal end portion of the radiofrequency energy delivery device through the introducer.

7. The method of claim 1, wherein the bone comprises a vertebral body, and wherein the nerve comprises a basivertebral nerve.

8. A method of treating back pain from a location within a bone of a spine, comprising:

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

inserting an energy delivery device within the cannula, the energy delivery device having two electrodes positioned along a distal end of the energy delivery device;

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

positioning a first electrode of the two electrodes on a first side of a nerve within the inner cancellous bone region of the bone and positioning a second electrode of the two electrodes on a second side of the nerve within the inner cancellous bone region of the bone; and

causing a current to be generated between the two electrodes to generate heat sufficient to denervate at least a portion of the nerve within the inner cancellous bone region of the bone.

9. The method of claim 8, wherein said energy delivery device is a bipolar radiofrequency energy delivery probe.

10. The method of claim 9, wherein the two electrodes comprise an active electrode at a distal tip of the bipolar radiofrequency energy delivery probe and a return electrode spaced proximal to the active electrode.

11. The method of claim 10, further comprising providing cooling to the active electrode.

12. The method of claim 10, wherein the cannula comprises a curved bore.

13. The method of claim 8, wherein the bone comprises a vertebral body.