Back pain treatment methods

• US 8,992,522 B2
• Filed: 04/12/2013
• Issued: 03/31/2015
• 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, Patel, Samit, Carrison, Harold
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): GIULIANI, THOMAS ANTHONY
• Application Number:
  US13/862,317
• Publication Number:
  US 20130324994A1
• Time in Patent Office: 718 Days
• Field of Search: 606/41, 607/99, 607/101, 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 energy delivery to a vertebral body, comprising:

inserting an introducer assembly through soft tissue and positioning a distal end of the introducer assembly at a surface of a vertebral body,

wherein the introducer assembly comprises an elongate shaft and a sharpened, straight stylet received within the elongate shaft;

confirming proper positioning of the introducer assembly;

withdrawing the sharpened, straight stylet from the elongate shaft;

inserting a curved cannula assembly through the elongate shaft and advancing a distal tip of the curved cannula assembly beyond the distal end of the introducer assembly and into an inner cancellous bone region of the vertebral body,

wherein the curved cannula assembly comprises a curved cannula and a curved stylet,

wherein a distal portion of the curved cannula and a distal portion of the curved stylet have corresponding curves that are configured to be aligned,

wherein the curved cannula assembly forms a curved path within the inner cancellous bone region toward a target treatment site;

confirming proper positioning of the curved cannula assembly with respect to the target treatment site;

withdrawing the curved stylet from the curved cannula;

advancing a distal end of a straight channeling stylet through the curved cannula and beyond an opening at a distal end of the curved cannula and through bone tissue to the target treatment site, thereby creating a linear path within the bone tissue;

removing the straight channeling stylet from the curved cannula while maintaining the position of the curved cannula and the introducer assembly;

inserting an energy delivery device within the curved cannula and advancing a distal end of the energy delivery device beyond the opening at the distal end of the curved cannula along the linear path within the bone tissue to the target treatment site;

confirming proper positioning of the distal end of the energy delivery device at the target treatment site; and

activating the energy delivery device to cause energy to be delivered to the target treatment site sufficient to denervate at least a portion of a basivertebral nerve within the vertebral body.

2. The method of claim 1, wherein the energy delivery device comprises a flexible radiofrequency energy delivery probe having an active element at a distal end of the flexible radiofrequency energy delivery probe.

3. The method of claim 1, wherein at least the portion of the basivertebral nerve is permanently denervated.

4. The method of claim 1, wherein at least the portion of the basivertebral nerve is temporarily denervated.

5. The method of claim 1, wherein the target treatment site is at a location within a region of the vertebral body located between 60% and 90% of the distance between the anterior and posterior ends of the vertebral body.

6. The method of claim 1, wherein the step of inserting an introducer assembly through soft tissue is performed using a transpedicular approach.

7. The method of claim 1, further comprising advancing the distal end of the introducer assembly through an outer cortical shell of the vertebral body and into the inner cancellous bone region.

8. The method of claim 1, wherein the curved cannula comprises a compliant, memory-retaining material.

9. The method of claim 1, wherein the curved cannula comprises a curve having a radius of between 0.4 inch and 1 inch.

10. The method of claim 1, wherein the curved stylet comprises a pre-curved portion, and wherein an angle of an inside of the pre-curved portion is less than an angle of an outside of the pre-curved portion, thereby facilitating curving in the bone tissue as the bone tissue pushes against the outside of the pre-curved portion.

11. A method of energy delivery to a vertebral body, comprising:

inserting an introducer assembly through soft tissue and positioning a distal end of the introducer assembly at a surface of a vertebral body,

inserting a curved cannula assembly through the introducer assembly and advancing a distal tip of the curved cannula assembly beyond the distal end of the introducer assembly and into an inner cancellous bone region of the vertebral body,

wherein the curved cannula assembly comprises a curved cannula and a curved stylet extending beyond an open distal end of the curved cannula;

wherein a distal portion of the curved cannula and a distal portion of the curved stylet have corresponding curves that are configured to be aligned,

wherein the curved cannula assembly forms a curved path within the inner cancellous bone region toward a target treatment site;

removing the curved stylet from the curved cannula;

advancing a distal end of a straight channeling stylet through the curved cannula and beyond the open distal end of the curved cannula and through bone tissue of the inner cancellous bone region to the target treatment site, thereby creating a linear path within the bone tissue;

removing the straight channeling stylet from the curved cannula;

inserting an energy delivery device within the curved cannula and advancing a distal end of the energy delivery device beyond the open distal end of the curved cannula along the linear path within the bone tissue to the target treatment site; and

delivering energy to at least a portion of a nerve within the vertebral body with the energy delivery device.

12. The method of claim 11, wherein the introducer assembly comprises a trocar or sharp stylet configured to pierce outer cortical bone of the vertebral body, wherein the energy delivery device comprises a radiofrequency energy delivery device having two electrodes, and wherein delivering energy to at least the portion of the nerve comprises ablating the nerve with the radiofrequency energy delivery device.

13. The method of claim 12, further comprising confirming positioning of the two electrodes with respect to the target treatment site.

14. The method of claim 11, wherein the curved cannula comprises a curve having a radius of between 0.4 inch and 1 inch.

15. The method of claim 11, wherein the curved stylet comprises a pre-curved portion, and wherein an angle of an inside of the pre-curved portion is less than an angle of an outside of the pre-curved portion, thereby facilitating curving in the bone tissue as the bone tissue pushes against the outside of the pre-curved portion.

16. The method of claim 11, wherein the energy delivery device comprises a flexible radiofrequency energy delivery probe having an active element at a distal end of the flexible radiofrequency energy delivery probe.

17. The method of claim 11, wherein delivering energy to the at least a portion of a nerve within the vertebral body comprises permanently denervating the portion of the nerve.

18. A method of energy delivery to a vertebral body, comprising:

providing an energy delivery system, said system comprising an introducer assembly, a curved cannula assembly, a straight channeling stylet and an energy delivery device, said system for;

(i) inserting the introducer assembly through soft tissue and positioning a distal end of the introducer assembly at a surface of a vertebral body,

(ii) inserting the curved cannula assembly through the introducer assembly and advancing a distal tip of the curved cannula assembly beyond the distal end of the introducer assembly and into an inner cancellous bone region of the vertebral body,

wherein the curved cannula assembly comprises a curved cannula and a curved stylet, wherein the curved stylet is configured to extend beyond an open distal end of the curved cannula;

wherein a distal portion of the curved cannula and a distal portion of the curved stylet have corresponding curves that are configured to be aligned,

wherein the curved cannula assembly forms a curved path within the inner cancellous bone region toward a target treatment site;

(iii) removing the curved stylet from the curved cannula;

(iv) advancing a distal end of the straight channeling stylet through the curved cannula and beyond the open distal end of the curved cannula and through bone tissue of the inner cancellous bone region to the target treatment site, thereby creating a linear path within the bone tissue;

(v) removing the straight channeling stylet from the curved cannula;

(vi) inserting the energy delivery device within the curved cannula and advancing a distal end of the energy delivery device beyond the open distal end of the curved cannula along the linear path within the bone tissue to the target treatment site; and

(vii) delivering energy to a nerve within the vertebral body with the energy delivery device to denervate the nerve.

19. The method of claim 18, wherein the energy delivery device comprises a flexible radiofrequency energy delivery probe having an active electrode at a distal tip of the flexible radiofrequency energy delivery probe and a return electrode positioned at a distance proximal to the active electrode to provide a controlled treatment region within the vertebral body, and wherein the return electrode comprises a cylindrical electrode.

20. The method of claim 18, wherein the energy delivery system is configured for delivering energy to heat the vertebral body sufficient to permanently ablate the nerve within the vertebral body, and wherein the curved cannula comprises a compliant, memory-retaining material.