IP Library › Granted Patent US 12,303,166
Granted Patent B2
US 12,303,166 · App. 18/778,387 · Granted May 20, 2025

Methods for accessing nerves within bone

Inventors: Richard Pellegrino (Leesburg, VA); Samit Patel (Palo Alto, CA); Harold Carrison (Pleasanton, CA)
Assignee: Relievant Medsystems, Inc.
A61B17/3472A61B17/16A61B17/1642A61B17/1671A61B17/34A61B17/3403A61B17/3421A61B17/8819A61B18/14A61B18/148A61B18/1487A61B18/149A61B18/18A61B18/1815A61B18/20A61N7/00A61B2018/00011A61B2018/00017A61B2018/00339A61B2018/00434A61B2018/00577A61B18/0206A61B18/1492A61N2007/0026A61N2007/025
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Quick Facts
Patent No.
US 12,303,166
App. No.
18/778,387
Granted
May 20, 2025
Kind
B2
Abstract

Methods of ablating a basivertebral nerve (BVN) in a lumbar or sacral vertebral body of a patient. An introducer and one or more instruments are selected after a pre-surgical evaluation. The introducer has a handle coupled to a shaft defining a central channel and an opening at a distal tip thereof. The introducer is inserted through a pedicle of the vertebral body such that its opening reaches a cancellous portion of the vertebral body. The one or more instruments are delivered through the central channel. A distal deflectable section of the one or more instruments is advanced past the introducer's opening to position it proximate to the BVN in a posterior midline section of the vertebral body. An active element is extended relative to at least a portion of the one or more instruments. Energy is delivered to the active element to ablate at least a portion of the BVN.

Claims (26)

1. A method of ablating a basivertebral nerve in a vertebral body of a patient, the method comprising: selecting an introducer and an instrument after a pre-surgical evaluation of the patient, the introducer having a handle coupled to a shaft defining a central channel and an opening at a distal tip of the introducer, the instrument comprising a proximal portion, a distal deflectable section, and a rotatable element at the proximal portion of the instrument; inserting the introducer through a pedicle of the vertebral body such that the opening at the distal tip of the introducer reaches a cancellous portion of the vertebral body; delivering the instrument through the central channel of the introducer and initiating a first rotation of the rotatable element; advancing the distal deflectable section of the instrument past the opening at the distal tip of the introducer and along a curved path to position the distal deflectable section at a target area proximal to a junction of the basivertebral nerve, wherein the rotatable element at the proximal portion of the instrument is in a rotated position as the distal deflectable section of the instrument is advanced relative to the opening at the distal tip of the introducer; and applying bipolar radiofrequency energy between a first electrode and a second electrode of a bipolar RF probe, the bipolar RF probe disposed in the curved path immediately adjacent to the basivertebral nerve in the target area to ablate at least a portion of the basivertebral nerve.

2. The method of claim 1 , wherein a second rotation of the rotatable element occurs when the distal deflectable section of the instrument is deployed at an angle of 5 degrees to 90 degrees.

3. The method of claim 2 , wherein the angle of 5 degrees to 90 degrees is relative to a longitudinal axis of the introducer.

4. The method of claim 1 , wherein inserting the introducer comprises inserting a stylet into the central channel of the introducer such that the stylet extends beyond the opening at the distal tip of the introducer and advancing the introducer and stylet simultaneously such that the stylet pierces bone as the introducer is delivered through the pedicle of the vertebral body.

5. A method of ablating a basivertebral nerve in a vertebral body of a patient, the method comprising: inserting an introducer through a pedicle of the vertebral body such that an opening at a distal tip of the introducer reaches a cancellous portion of the vertebral body, the introducer having a handle coupled to a shaft defining a central channel in communication with the opening; delivering an instrument through the central channel of the introducer, the instrument comprising a proximal portion, and a distal deflectable section, the distal deflectable section of the instrument comprising a plurality of reliefs or cuts configured to facilitate bending of the distal deflectable section of the instrument; advancing the distal deflectable section of the instrument past the opening at the distal tip of the introducer and along a nonlinear path to position the distal deflectable section in a target area proximal to a junction of the basivertebral nerve; and delivering bipolar radiofrequency energy from a first electrode of a bipolar RF probe to a second electrode of the bipolar RF probe located in at least a portion of the nonlinear path in the immediate vicinity of the basivertebral nerve in the target area to ablate at least a portion of the basivertebral nerve.

6. The method of claim 5 , wherein the distal deflectable section of the instrument curves at a radius of no more than 1.0 inch and arcs to an angle of 5 degrees to 90 degrees relative to a longitudinal axis of the introducer when at the target area.

7. The method of claim 5 , wherein the instrument further comprises a rotatable element, and wherein a rotation of the rotatable element occurs when the distal deflectable section of the instrument is deployed at an angle of 5 degrees to 90 degrees.

8. The method of claim 7 , wherein the angle of 5 degrees to 90 degrees is relative to a longitudinal axis of the introducer.

9. The method of claim 5 , further comprising using a channeling instrument to move along the nonlinear path in the cancellous portion of the vertebral body.

10. The method of claim 5 , wherein the distal deflectable section is positioned in a posterior midline section of the vertebral body.

11. The method of claim 10 , wherein the vertebral body is a lumbar vertebral body.

12. The method of claim 5 , wherein the vertebral body is a sacral vertebral body.

13. The method of claim 12 , wherein the sacral vertebral body comprises an S1 vertebral body.

14. The method of claim 5 , further comprising injecting a compound or agent near the target area.

15. The method of claim 5 , wherein the treatment probe contributes to fluidic heating near the target area.

16. A method of ablating a basivertebral nerve in a vertebral body of a patient, the method comprising: inserting an introducer through a pedicle of the vertebral body such that an opening at a distal tip of the introducer reaches a cancellous portion of the vertebral body, the introducer having a handle coupled to a shaft defining a central channel in communication with the opening, wherein inserting the introducer comprises inserting a stylet into the central channel of the introducer such that the stylet extends beyond the opening at the distal tip of the introducer and advancing the introducer and stylet simultaneously such that the stylet pierces bone as the introducer is delivered through the pedicle of the vertebral body; delivering an instrument through the central channel of the introducer, the instrument comprising a proximal portion, a distal deflectable section, and a rotatable element at the proximal portion of the instrument, wherein the distal deflectable section of the instrument is configured to penetrate the cancellous portion of the vertebral body to form a curved path; initiating a first rotation of the rotatable element; advancing the distal deflectable section of the instrument past the opening at the distal tip of the introducer to a target area proximal to a junction of the basivertebral nerve, wherein a second rotation of the rotatable element occurs when the distal deflectable section of the instrument is deployed at an angle of 5 degrees to 90 degrees; and applying bipolar radiofrequency energy between a first electrode and a second electrode of a bipolar RF probe disposed in the curved path at a treatment location immediately adjacent to the basivertebral nerve in the target area to ablate at least a portion of the basivertebral nerve.

17. The method of claim 16 , wherein the rotatable element at the proximal portion of the instrument is in a rotated position as the distal deflectable section of the instrument is advanced relative to the opening at the distal tip of the introducer.

18. The method of claim 16 , wherein the rotatable element at the proximal portion of the instrument is in a rotated position as the instrument is delivered in the central channel of the introducer.

19. The method of claim 16 , wherein the distal deflectable section of the instrument comprises a plurality of reliefs or cuts configured to facilitate bending of the distal deflectable section of the instrument.

20. The method of claim 16 , wherein the angle of 5 degrees to 90 degrees is relative to a longitudinal axis of the introducer.

21. A method of ablating a basivertebral nerve in a vertebral body of a patient, the method comprising: selecting an introducer and one or more instruments after a pre-surgical evaluation of the patient, the introducer having a handle coupled to a shaft defining a central channel and an opening at a distal tip of the introducer, the one or more instruments comprising a proximal portion, and a distal deflectable section; inserting the introducer through a pedicle of the vertebral body such that the opening at the distal tip of the introducer reaches a cancellous portion of the vertebral body, the vertebral body being a lumbar vertebral body or a sacral vertebral body; delivering the one or more instruments through the central channel of the introducer; advancing the distal deflectable section of the one or more instruments past the opening at the distal tip of the introducer to traverse the cancellous portion of the vertebral body in a curved path and to position the distal deflectable section at a target area proximal to a junction of the basivertebral nerve in a posterior midline section of the vertebral body; and delivering energy from a first electrode of a bipolar RF probe to a second electrode of the bipolar RF probe to ablate at least a portion of the basivertebral nerve when the bipolar RF probe is located in the curved path in the immediate vicinity of the basivertebral nerve in the target area.

22. The method of claim 21 , wherein the sacral vertebral body comprises an S1 vertebral body.

23. The method of claim 21 , wherein, after the one or more instruments is advanced relative to the introducer, the distal deflectable section of the one or more instruments curves at a radius of 0.6 inches to 1.0 inches and arcs to an angle of 5 degrees to 90 degrees, wherein the angle of 5 degrees to 90 degrees is relative to a longitudinal axis of the introducer.

24. The method of claim 21 , wherein the one or more instruments comprises a deflectable canula and a deflectable stylet, wherein a distal tip of the deflectable stylet protrudes from a distal tip of the deflectable canula by at least 1/16th of an inch and no more than 3/16th of an inch.

25. The method of claim 21 , wherein the portion of the one or more instruments comprises the distal deflectable section of the one or more instruments.

26. The method of claim 21 , wherein the one or more instruments are included in an instrument kit, and wherein the instrument kit comprises a stylet and a cannula.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 11, 2024
From: PELLEGRINO, RICHARD; PATEL, SAMIT; CARRISON, HAROLD
To: RELIEVANT MEDSYSTEMS, INC.
Reel/Frame 069198/0757 →
Continuity (6)
Continuation 16368453 · Mar 28, 2019
Continuation 15040268 · Feb 10, 2016
Continuation 13862242 · Apr 12, 2013
Continuation 12566895 · Sep 25, 2009
Provisional Application 61100553 · Sep 26, 2008
Related Publication 20240366265A1 · Nov 7, 2024
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