Nerve modulation methods

• US 9,173,676 B2
• Filed: 01/13/2014
• Issued: 11/03/2015
• 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:
  US14/153,922
• Publication Number:
  US 20140336667A1
• Time in Patent Office: 659 Days
• Field of Search: 607/99, 606/41
• US Class Current: 1/1
• 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 distal opening at the distal end of the trocar. The system includes a curved cannula sized to be received in the central channel, the curved cannula comprising a curved distal end configured to be extended outward from the distal opening to generate a curved path extending away from the trocar. The curved cannula has a central passageway having a diameter configured to allow a treatment device to be delivered through the central passageway to a location beyond the curved path.

Claims

1. A method for channeling a path into bone to a treatment location in the body of a patient, comprising:

inserting an introducer into a region of the bone;

wherein the introducer comprises a central channel and an axial opening at a distal tip of the introducer;

delivering a cannula through said central channel and advancing a distal tip of the cannula to said axial opening;

wherein the cannula comprises a deflectable distal portion with a preformed curve such that the deflectable distal portion straightens while being delivered through the introducer and curves upon exiting the axial opening at the distal tip of the introducer;

extending the deflectable distal portion of the cannula out of the axial opening of the introducer to generate a curved path in the bone corresponding to the preformed curve of the deflectable distal portion;

inserting a straight channeling stylet into the central passageway of the cannula; and

advancing a distal tip of the straight channeling stylet be and the distal tip of the cannula,

wherein the straight channeling stylet is flexibly deformable to navigate the cannula yet retain a straight form upon exiting the cannula,

wherein an entire length of the straight channeling stylet is straight in an unconstrained configuration; and

delivering a flexible radiofrequency energy delivery device through the central passageway in said cannula to the treatment location beyond the curved path.

2. The method of claim 1, wherein inserting the introducer into the region of bone comprises:

inserting a stylet into the central channel of the introducer;

advancing a distal tip of the stylet beyond the axial opening of the introducer; and

inserting the stylet and introducer simultaneously into the region of bone such that the stylet pierces the bone as the introducer and stylet are being delivered to the region of the bone.

3. The method of claim 1, wherein extending the deflectable distal portion of the cannula out of the axial opening of the introducer comprises:

inserting a curved stylet into the central passageway of the cannula until a distal tip of the curved stylet extends to at least an axial opening of the cannula; and

simultaneously extending the cannula and curved stylet out of the axial opening of the introducer such that the curved stylet blocks the axial opening of the cannula while being delivered into the bone.

4. The method of claim 3, wherein the curved stylet has a curved distal portion corresponding to the deflectable distal portion of the cannula, and wherein the curved stylet reinforces the curved shape of the deflectable distal portion of the cannula as the deflectable distal portion of the cannula is extended out of the axial opening of the introducer.

5. The method of claim 1, wherein inserting the introducer into the region of the bone comprises inserting the introducer through a cortical bone region and into a cancellous bone region of a vertebral body.

6. The method of claim 5, wherein the treatment location comprises a nerve of the vertebral body.

7. The method of claim 6, further comprising delivering radiofrequency energy to the treatment location sufficient to ablate at least a portion of the nerve.

8. A method for channeling a path into bone to a treatment location in the body of a patient, comprising:

inserting a curved stylet having a curved distal portion into a central passageway of a cannula having a curved distal portion;

aligning the curved distal portion of the curved stylet and the curved distal portion of the cannula;

advancing a distal tip of the curved stylet at least to an opening at a distal tip of the cannula;

advancing the curved stylet and cannula together into a cancellous region of a vertebral body and toward a location of a nerve within the vertebral body, thereby forming a curved path within the cancellous region toward the location of the nerve;

removing the curved stylet from the cannula;

inserting a straight flexible stylet into the central passageway of the cannula;

advancing a distal tip of the straight flexible stylet in a straight path beyond the distal tip of the cannula to the location of the nerve; and

removing the straight flexible stylet,

wherein an entire length of the straight flexible stylet is straight in an unconstrained configuration.

9. The method of claim 8, further comprising delivering a treatment device through the central passageway of the cannula to the location of the nerve.

10. The method of claim 9, further comprising ablating the nerve with the treatment device.

11. The method of claim 9, further comprising stimulating the nerve with the treatment device.

12. The method of claim 9, further comprising delivering an agent to the location using the treatment device.

13. The method of claim 9, further comprising delivering steam to the location using the treatment device.

14. The method of claim 9, further comprising delivering cryogenic cooling to the location using the treatment device.

15. The method of claim 9, further comprising severing the nerve using the treatment device.

16. A method for channeling a path into bone to a treatment location in the body of a patient, comprising:

inserting a curved stylet having a curved distal portion into a central passageway of a cannula having a curved distal portion;

aligning the curved distal portion of the curved stylet and the curved distal portion of the cannula;

advancing a distal tip of the curved stylet at least to an opening at a distal tip of the cannula;

advancing the curved stylet and cannula together into a cancellous region of the bone and toward a location of a nerve within the bone, thereby forming a curved path within the cancellous region toward the location of the nerve;

removing the curved stylet from the cannula;

inserting a straight flexible stylet into the central passageway of the cannula;

advancing a distal tip of the straight flexible stylet beyond the distal tip of the cannula along a straight path to the location of the nerve; and

removing the straight flexible stylet,

wherein an entire length of the straight flexible stylet is straight in an unconstrained configuration.

17. The method of claim 16, wherein the straight flexible stylet is flexibly deformable navigate the cannula yet retain a straight form upon exiting the cannula.

18. The method of claim 16, wherein the treatment location is within a cancellous bone region of a vertebral body, and wherein the treatment location is selected based on a location of a nerve within the vertebral body.