IP Library Granted Patent US 10,905,440
Granted Patent B2
US 10,905,440 · App. 15/669,399 · Granted Feb 2, 2021

Nerve modulation systems

Inventors: Richard C. Pellegrino (Ashburn, VA); Samit Patel (San Francisco, CA); Harold Carrison (Pleasanton, CA)
Assignee: Relievant Medsystems, Inc.
A61B17/1642A61B17/1671A61B17/3403A61B17/3421A61B17/3468A61B17/3472A61B18/148A61B18/1487A61B17/3423A61B18/1206A61B2017/00314A61B2017/00323A61B2017/00331A61B2017/3405A61B2018/0044A61B2018/00339A61B2018/00565A61B2018/00577A61B2018/126
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Quick Facts
Patent No.
US 10,905,440
App. No.
15/669,399
Granted
Feb 2, 2021
Kind
B2
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 (57)

1. A system for accessing and treating a target treatment region within a vertebral body, the system comprising:

an elongate shaft having a proximal end and a distal end,

wherein the elongate shaft comprises a central lumen extending from the proximal end to the distal end,

wherein the proximal end of the elongate shaft comprises a handle,

wherein the distal end of the elongate shaft comprises an axial opening;

a first stylet comprising a proximal stop configured to abut against the handle of the elongate shaft and a sharp distal tip, wherein the stylet is sized and configured such that the sharp distal tip of the stylet extends beyond the axial opening of the distal end of the elongate shaft when inserted within the elongate shaft until the proximal stop abuts against the handle of the elongate shaft,

wherein the sharp distal tip of the stylet is configured to pierce through a cortical shell of the vertebral body to create an initial path toward the target treatment region within the vertebral body; and

a curveable instrument configured to be introduced through the central lumen of the elongate shaft and beyond the axial opening at the distal end of the elongate shaft after removal of the first stylet from the elongate shaft,

wherein the curveable instrument comprises a locking nut configured to be moved proximally and distally along the curveable instrument so as to allow for advancement of the curveable instrument beyond the axial opening at the distal end of the elongate shaft when the locking nut is moved to a proximal position along the curveable instrument away from the handle of the elongate shaft and so as to stop additional advancement of the curveable instrument when the locking nut is positioned to engage with the handle of the elongate shaft,

wherein the curveable instrument is further configured to create a curved path within a cancellous interior of the vertebral body beyond the initial path to facilitate curved access to the target treatment region within the vertebral body;

a second stylet configured to be introduced into the curveable instrument, wherein the second stylet comprises a sharpened distal tip adapted to extend beyond an axial opening at a distal end of the curveable instrument; and a treatment device configured to be advanced out of the axial opening at the distal end of the curveable instrument after the target treatment region has been reached and after removal of the second stylet from the curveable instrument,

wherein the treatment device comprises an electrode configured to deliver energy to the target treatment region sufficient to ablate a basivertebral nerve within the target treatment region.

2. The system of claim 1 :

wherein the treatment device comprises a flexible bipolar radiofrequency energy delivery device having two electrodes configured to deliver energy to the target treatment region.

3. The system of claim 1 , wherein the treatment device is selected from the group consisting of: a monopolar radiofrequency energy delivery device and a tripolar radiofrequency energy delivery device.

4. The system of claim 1 , further comprising a sensor.

5. The system of claim 1 , wherein the curveable instrument comprises a tube having a pattern of reliefs or cuts in a wall of the tube.

6. The system of claim 1 , further comprising a bone cement delivery device.

7. The system of claim 1 , wherein the curveable instrument comprises a pre-curved tube.

8. A system for accessing and treating a target treatment region within a bone, the system comprising:

an elongate shaft having a proximal end and a distal end,

wherein the elongate shaft comprises a central lumen extending from the proximal end to the distal end,

wherein the proximal end of the elongate shaft comprises a handle, and

wherein the distal end of the elongate shaft comprises an opening;

a first stylet comprising a proximal stop configured to abut against the handle of the elongate shaft and a sharp distal tip, wherein the stylet is sized and configured such that the sharp distal tip of the stylet extends beyond the opening at the distal end of the elongate shaft when inserted within the elongate shaft until the proximal stop abuts against the handle of the elongate shaft,

wherein the sharp distal tip of the stylet is configured to pierce through a cortical shell of the bone to create an initial path toward the target treatment region within the bone; and

a second instrument configured to be introduced through the central lumen of the elongate shaft and beyond the opening at the distal end of the elongate shaft after removal of the first stylet from the elongate shaft,

wherein the second instrument comprises a locking nut configured to be moved proximally and distally along the second instrument so as to allow for advancement of the second instrument beyond the opening at the distal end of the elongate shaft when the locking nut is moved to a proximal position along the second instrument away from the handle of the elongate shaft and so as to stop additional advancement of the second instrument when the locking nut is positioned to engage with the handle of the elongate shaft,

wherein the second instrument comprises a deflectable distal tip that is further configured to create a curved path within a cancellous interior of the bone beyond the initial path to facilitate curved access to the target treatment region within the bone;

a second stylet configured to be introduced into the second instrument, wherein the second stylet comprises a sharpened distal tip adapted to extend beyond an axial opening at a distal end of the second instrument; and a treatment element configured to be advanced out of the axial opening at the distal end of the second instrument after the target treatment region has been reached and after removal of the second stylet from the second instrument,

wherein the treatment element comprises an electrode configured to deliver energy to the target treatment region sufficient to ablate tissue within the target treatment region.

9. The system of claim 8 :

wherein the second instrument comprises a tube having a pattern of reliefs or cuts in a wall of the tube, and

wherein the treatment element comprises a second electrode.

10. The system of claim 8 , wherein the tissue comprises an intraosseous nerve.

11. The system of claim 8 , wherein the tissue comprises a basivertebral nerve.

12. The system of claim 8 , further comprising a sensor.

13. The system of claim 8 , wherein the bone comprises a vertebra.

14. The system of claim 8 , wherein the second instrument comprises a cannula.

15. The system of claim 8 , wherein the deflectable distal tip of the second instrument is pre-curved.

16. The system of claim 8 , further comprising a bone cement delivery device.

17. The system of claim 8 , wherein the second instrument comprises a tube having a pattern of reliefs or cuts in a wall of the tube.

18. A system for accessing and treating a target treatment region within a vertebral body, the system comprising:

an elongate shaft having a proximal end and a distal end,

wherein the elongate shaft comprises a central lumen extending from the proximal end to the distal end,

wherein the proximal end of the elongate shaft comprises a handle,

wherein the distal end of the elongate shaft comprises an axial opening;

a first stylet comprising a proximal stop configured to abut against the handle of the elongate shaft and a sharp distal tip, wherein the stylet is sized and configured such that the sharp distal tip of the stylet extends beyond the axial opening of the distal end of the elongate shaft when inserted within the elongate shaft until the proximal stop abuts against the handle of the elongate shaft,

wherein the sharp distal tip of the stylet is configured to pierce through a cortical shell of the vertebral body to create an initial path toward the target treatment region within the vertebral body; and

a second instrument configured to be introduced through the central lumen of the elongate shaft and beyond the axial opening at the distal end of the elongate shaft after removal of the first stylet from the elongate shaft;

a second stylet configured to be introduced into the second instrument, wherein the second stylet comprises a sharpened distal tip adapted to extend beyond an axial opening at a distal end of the second instrument,

wherein the second stylet and the second instrument are further configured to create a curved path within a cancellous interior of the vertebral body beyond the initial path to facilitate curved access to the target treatment region within the vertebral body; and

a treatment device configured to be advanced out of the axial opening at the distal end of the second instrument after the target treatment region has been reached and after removal of the second stylet from the second instrument,

wherein the treatment device comprises an electrode configured to deliver energy to the target treatment region sufficient to ablate a basivertebral nerve within the target treatment region.

19. The system of claim 18 : wherein the treatment device comprises a flexible bipolar radiofrequency energy delivery device configured to deliver energy to the target treatment region, wherein a distal portion of the second instrument and a distal portion of the second stylet are pre-curved, and

wherein the second instrument and the second stylet comprise alignment members configured to align a curve of the second stylet with a curve of the second instrument.

20. The system of claim 18 , wherein the second instrument is a curveable instrument.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 4, 2018
From: PELLEGRINO, RICHARD; PATEL, SAMIT; CARRISON, HAROLD
To: RELIEVANT MEDSYSTEMS, INC.
Reel/Frame 044539/0925 →
Continuity (9)
Continuation 15241528 · Aug 19, 2016
Continuation 14695330 · Apr 24, 2015
Continuation 14147024 · Jan 3, 2014
Continuation 13617470 · Sep 14, 2012
Continuation 13612561 · Sep 12, 2012
Continuation 12683555 · Jan 7, 2010
Continuation In Part 12566895 · Sep 25, 2009
Provisional Application 61100553 · Sep 26, 2008
Related Publication 20180021048A1 · Jan 25, 2018
Cited By (14)
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