Vertebral denervation

• US 8,628,528 B2
• Filed: 04/12/2013
• Issued: 01/14/2014
• 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, Patel, Samit, Carrison, Harold
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): GIULIANI, THOMAS ANTHONY
• Application Number:
  US13/862,306
• Publication Number:
  US 20130325001A1
• Time in Patent Office: 277 Days
• Field of Search: 606/32, 606/41, 606/46, 606/48, 606/50, 606/129, 604/114, 607 98-100, 607/113, 607/115, 607/117
• US Class Current: 606/41
• CPC Class Codes: A61B 17/1642 for producing a curved bore
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• 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 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 18/1206 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 2017/00331 with preformed bends
• CPC Class Codes: A61B 2017/3405 using mechanical guide means
• CPC Class Codes: A61B 2017/3454 Details of tips
• CPC Class Codes: A61B 2018/00017 with gas
• CPC Class Codes: A61B 2018/00339 Spine, e.g. intervertebral disc
• 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 2018/126 : bipolar
• CPC Class Codes: A61B 2018/1475 : Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61F 7/007 : characterised by electric heating
• CPC Class Codes: A61N 1/0551 : Spinal or peripheral nerve electrodes

Abstract

System and methods for channeling a path into bone include a trocar having a proximal end, distal end and a central channel disposed along a central axis of the trocar. The trocar includes a radial opening at or near the distal end of the trocar. The system includes a curveable cannula sized to be received in the central channel, the curveable cannula comprising a curveable distal end configured to be extended laterally outward from the radial opening in a curved path extending away from the trocar. The curveable cannula has a central passageway having a diameter configured to allow a probe to be delivered through the central passageway to a location beyond the curved path.

Claims

1. A method of energy delivery to a nerve within a vertebral body, comprising:

identifying a target energy delivery region within an inner cancellous bone portion of a vertebral body corresponding to a likely location of a portion of a basivertebral nerve,

wherein the target energy delivery region is located within a posterior section of the vertebral body;

inserting a cannula and a first stylet within the inner cancellous bone portion of the vertebral body, the first stylet being slidably received within a passageway of the cannula,

wherein a distal portion of the cannula and a distal portion of the first stylet are curved,

wherein a distal end of the curved portion of the first stylet extends beyond a distal end of the curved portion of the cannula,

wherein the curved stylet and the curved cannula have mating proximal ends that align the curve of the first stylet with the curve of the curved cannula;

advancing a distal end of the first stylet and a distal end of the cannula together toward a midline of the vertebral body, thereby forming a curved path toward the target energy delivery region;

removing the first stylet from the cannula;

inserting a channeling stylet within the passageway of the cannula and advancing a distal end of the channeling stylet beyond the distal end of the cannula,

wherein the channeling stylet is flexibly deformable so as to navigate the cannula yet rigid enough to retain a straight form upon exiting the distal end of the cannula,

forming a linear path beyond the curved path to the target energy delivery region by advancing the distal end of the channeling stylet beyond the curved path;

removing the channeling stylet from the cannula;

inserting an energy delivery device through the passageway of the cannula to the target energy delivery region; and

delivering energy to the target energy delivery region using the energy delivery device.

2. The method of claim 1, 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.

3. The method of claim 1, wherein delivering energy to the target energy delivery region comprises delivering energy sufficient to ablate a basivertebral nerve within the target energy delivery region.

4. The method of claim 1, wherein delivering energy to the target energy delivery region comprises delivering energy sufficient to stimulate a basivertebral nerve within the target energy delivery region.

5. The method of claim 1, wherein the energy delivery device is an ultrasound device configured to deliver energy to the target energy delivery region.

6. The method of claim 1, wherein the energy delivery device is configured to generate heat within the target energy delivery region sufficient to ablate a nerve within the target energy delivery region.

7. The method of claim 1, wherein the mating proximal end of the first stylet comprises a cap having an alignment pin configured to engage with a notch of the mating proximal end of the cannula.

8. The method of claim 1, wherein the distal tip of the first stylet has a length configured to extend beyond the distal tip of the cannula by about 1/16 to 3/16 inches.

9. The method of claim 1, wherein the energy delivery device comprises an active element configured to be activated to deliver the energy to the target energy delivery region.

10. A method of energy delivery to a nerve within a bone of the spine, comprising:

identifying a target heating zone within an inner cancellous bone portion of the bone corresponding to a likely location of a portion of the nerve,

inserting a cannula and a first stylet together within the inner cancellous bone portion of the bone, the first stylet being slidably received within a passageway of the cannula,

wherein a distal portion of the cannula and a distal portion of the first stylet are curved,

wherein the first stylet and the cannula each have mating proximal ends that align the curve of the distal portion of the first stylet with the curve of the distal portion of the curved cannula;

advancing a distal end of the first stylet and a distal end of the cannula together toward the target heating zone, thereby forming a curved path;

removing the first stylet from the cannula;

inserting a channeling stylet within the passageway of the cannula and advancing a distal end of the channeling stylet beyond the distal end of the cannula,

wherein the channeling stylet is flexibly deformable so as to navigate the cannula yet rigid enough to retain a straight form upon exiting the distal end of the cannula,

forming a linear path beyond the curved path to the target heating zone by advancing the distal end of the channeling stylet beyond the curved path;

removing the channeling stylet from the cannula;

inserting a heat-generating device through the passageway of the cannula to the target heating zone; and

generating heat within the target heating zone using the heat-generating device.

11. The method of claim 10, wherein the heat-generating device comprises a radiofrequency probe configured to deliver radiofrequency energy to generate heat within the target heating zone.

12. The method of claim 10, wherein the heat-generating device comprises a fluidic heating device.

13. The method of claim 10, wherein the heat-generating device comprises a laser energy device.

14. The method of claim 10, wherein the heat-generating device comprises an ultrasound device.

15. The method of claim 10, wherein the heat-generating device is configured to generate heat within the target heating zone sufficient to ablate a nerve within the target heating zone.

16. The method of claim 10, wherein the mating proximal end of the first stylet comprises a cap having an alignment pin configured to engage with a notch of the mating proximal end of the cannula.

17. A method of energy delivery to a nerve within a vertebral body, comprising:

providing an energy delivery system, said system comprising a first stylet, a cannula, a channeling stylet and an energy delivery device, said system for;

(i) inserting the cannula and the first stylet within an inner cancellous bone portion of the vertebral body, the first stylet being slidably received within a passageway of the cannula,

wherein a distal portion of the cannula and a distal portion of the first stylet are curved,

wherein a distal end of the curved portion of the first stylet extends beyond a distal end of the curved portion of the cannula,

wherein the first stylet and the cannula have mating proximal ends that align the curve of the distal portion of the first stylet with the curve of the distal portion of the cannula;

(ii) advancing a distal end of the first stylet and a distal end of the cannula together toward a midline of the vertebral body, thereby forming a curved path toward an identified treatment zone corresponding to a likely location of the portion of the nerve within the vertebral body;

(iii) removing the first stylet from the cannula;

(iv) inserting the channeling stylet within the passageway of the cannula and advancing a distal end of the channeling stylet beyond the distal end of the cannula,

wherein the channeling stylet is flexibly deformable so as to navigate the cannula yet rigid enough to retain a straight form upon exiting the distal end of the cannula,

(v) forming a linear path beyond the curved path to the treatment zone by advancing the distal end of the channeling stylet beyond the curved path;

(vi) removing the channeling stylet from the cannula;

(vii) inserting an energy delivery device through the passageway of the cannula to the treatment zone; and

(viii) delivering energy to heat the treatment zone sufficient to denervate the nerve.

18. The method of claim 17, further comprising providing a diagnostic device for performing imaging prior to or in conjunction with energy delivery.

19. The method of claim 17, wherein the energy delivery device comprises an active element configured to be activated to deliver the energy to the treatment zone, and wherein the energy delivery device is configured to generate heat within the treatment zone sufficient to ablate the nerve within the treatment zone.

20. The method of claim 17, wherein the mating proximal end of the first stylet comprises a cap having an alignment pin configured to engage with a notch of the mating proximal end of the cannula.