Systems for denervation of basivertebral nerves

• US 8,623,014 B2
• Filed: 09/14/2012
• Issued: 01/07/2014
• 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, Patel, Samit, Carrison, Harold
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): Giuliani, Thomas
• Application Number:
  US13/617,470
• Publication Number:
  US 20130012933A1
• Time in Patent Office: 480 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 allow a probe to be delivered through the central passageway to a location beyond the curved path.

Claims

1. A system for therapeutically heating a vertebral body to treat back pain, comprising:

a trocar having a lumen,

a curved cannula having an internal passageway and a first alignment member at a proximal portion of the curved cannula,

a first stylet,

a second stylet,

a third stylet,

wherein the first stylet is configured for insertion into the lumen of the trocar such that a distal end of the first stylet extends beyond a distal end of the trocar,

wherein the extended distal end of the first stylet is sufficiently sharp to penetrate through a cortical shell of the vertebral body,

wherein the cannula is configured to be inserted within the lumen of the trocar upon removal of the first stylet,

wherein a distal end portion of the cannula is curved off axis,

wherein a distal end portion of the second stylet is configured to curve to correspond to the curved distal end portion of the cannula upon insertion of the second stylet within the internal passageway of the cannula and advancement of a distal end of the second stylet to a distal end of the cannula,

wherein the second stylet comprises a second alignment member configured to be aligned with the first alignment member of the cannula to facilitate proper alignment of corresponding curved distal end portions of the cannula and the second stylet,

wherein the second stylet and the cannula are together configured to form a curved path toward a target location within an inner cancellous bone region of the vertebral body,

wherein the third stylet comprises a straight channeling stylet configured to be inserted within the internal passageway of the cannula upon on removal of the second stylet,

wherein a distal end of the third stylet is configured to be advanced out of the distal end of the cannula to form a linear path beyond the curved path;

a bipolar radiofrequency (“

RF”

) energy delivery device having two electrodes configured to deliver RF energy to the target location;

wherein the diameter of the internal passageway of the cannula is configured to receive the bipolar RF energy device,

wherein the curved distal end portion of the cannula is configured to guide the two electrodes of the bipolar RF energy delivery device to the target location, and

wherein the RF energy is configured to heat the target location sufficient to denervate a basivertebral nerve at the target location.

2. The system of claim 1, wherein the RF energy is configured to heat the target location sufficient to ablate the basivertebral nerve.

3. The system of claim 1, wherein the RF energy is configured to heat the target location sufficient to denervate the basivertebral nerve without necrosis of tissue.

4. The system of claim 1, wherein the target location is between, but exclusive of, a basivertebral nerve junction and an outer cortical bone region of the vertebral body.

5. The system of claim 1, wherein the target location is proximal to a junction of the basivertebral nerve.

6. The system of claim 1, wherein the target location is in a region of the vertebral body located between 60% and 90% of the distance between the anterior and posterior ends of the vertebral body.

7. The system of claim 1, wherein the first alignment member of the cannula comprises an alignment pin.

8. The system of claim 1, wherein the curved distal end portion of the cannula is pre-curved.

9. A system for therapeutically heating a vertebral body to treat back pain, comprising:

a trocar having a lumen,

an energy delivery device configured to deliver energy to heat a target location of at least a portion of a basivertebral nerve within the vertebral body;

a cannula having an internal passageway and a distal opening at a distal end of the cannula,

wherein a distal end portion of the cannula is curved off axis, thereby facilitating formation of a curved path within the vertebral body toward the target location by a curved stylet inserted through the internal passageway of the cannula;

a straight channeling stylet configured to be inserted through the internal passageway of the cannula after removal of the curved stylet and advanced out of the distal opening at the distal end of the cannula to form a linear path to the target location beyond the curved path,

wherein the diameter of the internal passageway of the cannula is configured to receive the energy delivery device,

wherein the distal opening of the cannula provides a working portal for the energy delivery device as it is advanced past the distal end of the cannula,

wherein the cannula has a length sufficient to provide access to the target location within the vertebral body by the energy delivery device,

wherein the target location is within an inner cancellous bone region of the vertebral body, and

wherein the energy is configured to heat the target location sufficient to denervate the basivertebral nerve at the target location.

10. The system of claim 9, wherein the energy is configured to heat the target location sufficient to ablate the basivertebral nerve.

11. The system of claim 9, wherein the energy is configured to heat the target location sufficient to denervate the basivertebral nerve without necrosis of tissue.

12. The system of claim 9, wherein the energy delivery device comprises a bipolar radiofrequency probe comprising at least one electrode.

13. The system of claim 12, wherein the bipolar radiofrequency probe comprises an active electrode and a return electrode.

14. The system of claim 9, wherein the energy delivery device comprises a microwave energy delivery device.

15. The system of claim 9, wherein the energy delivery device comprises an ultrasonic energy delivery device.

16. The system of claim 9, wherein the target location is between, but exclusive of, a basivertebral nerve junction and an outer cortical bone region of the vertebral body.

17. The system of claim 9, wherein the target location is proximal to a junction of the basivertebral nerve.

18. The system of claim 9, wherein the target location is in a region of the vertebral body located between 60% and 90% of the distance between the anterior and posterior ends of the vertebral body.

19. The system of claim 9, wherein the curved distal end portion of the cannula is pre-curved.

20. A system for therapeutically heating a vertebral body to treat back pain, comprising:

a trocar having a lumen,

a curved cannula having an internal passageway and a first alignment member at a proximal portion of the curved cannula,

a straight sharpened stylet,

a curved stylet comprising a curved distal end portion,

a straight channeling stylet,

wherein the straight sharpened stylet is configured for insertion into the lumen of the trocar such that a distal end of the straight sharpened stylet extends beyond a distal end of the trocar,

wherein the extended distal end of the straight sharpened stylet is configured to penetrate a cortical shell of the vertebral body,

wherein the cannula is configured to be inserted within the lumen of the trocar,

wherein a length of the distal end portion of the cannula is curved,

wherein the distal end portion of the curved stylet is configured to correspond to the curved distal end portion of the cannula upon insertion of the curved stylet within the internal passageway of the cannula and advancement of a distal end of the curved stylet to a distal end of the cannula,

wherein the curved stylet comprises a second alignment member configured to be aligned with the first alignment member of the cannula to facilitate proper alignment of the corresponding curved distal end portions of the cannula and the curved stylet,

wherein the curved stylet and the cannula are together configured to form a curved channel toward a target region within an inner cancellous bone region of the vertebral body;

wherein the straight channeling stylet is configured to be inserted within the internal passageway of the cannula upon removal of the curved stylet,

wherein a distal end of the straight channeling stylet is configured to be advanced out of the distal end of the cannula to form a linear channel beyond the curved channel;

a radiofrequency (“

RF”

) energy delivery device having at least one electrode configured to deliver RF energy to the target region;

wherein the diameter of the internal passageway of the cannula is configured to receive the RF energy device,

wherein the curved distal end portion of the cannula is configured to guide the at least one electrode of the RF energy delivery device to the target region, and

wherein the RF energy is configured to heat the target region sufficient to denervate a basivertebral nerve at the target region.