IP Library Granted Patent US 11,596,468
Granted Patent B2
US 11,596,468 · App. 16/160,155 · Granted Mar 7, 2023

Intraosseous nerve treatment

Inventors: Richard Pellegrino (Leesburg, VA); Paula Papineau (West Bridgewater, MA); John S. Crombie (East Hanover, NJ); Samit Patel (Palo Alto, CA); Thomas Ryan (Austin, TX)
Assignee: Relievant Medsystems, Inc.
A61B18/1487A61B17/3472A61B17/8819A61B18/082A61B18/12A61B18/1206A61B18/148A61B18/1492A61B18/18A61N1/06A61N5/00A61B17/320068A61B17/8805A61B18/02A61B18/16A61B18/1815A61B18/20A61B18/22A61B2017/00261A61B2017/00331A61B2017/00867A61B2017/320069A61B2018/00017A61B2018/0044A61B2018/0072A61B2018/00339A61B2018/00434A61B2018/00565A61B2018/00577A61B2018/00589A61B2018/00642A61B2018/00761A61B2018/00791A61B2018/00821A61B2018/126A61B2018/1425A61B2018/1807A61B2018/2005A61B2034/301A61B2090/374A61B2218/002A61N1/0551A61N7/00
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Quick Facts
Patent No.
US 11,596,468
App. No.
16/160,155
Granted
Mar 7, 2023
Kind
B2
Abstract

Methods and systems for modulating intraosseous nerves (e.g., nerves within bone) are provided. For example, the methods and systems described herein may be used to modulate (e.g., denervate, ablate) basivertebral nerves within vertebrae. The modulation of the basivertebral nerves may facilitate treatment of chronic back pain. The modulation may be performed by a neuromodulation device an energy delivery device).

Claims (38)

1. A method of treating back pain in a patient, the method comprising:

inserting a cannula through an outer cortical bone region of a vertebral body and into an inner cancellous bone region of the vertebral body;

inserting a distal end portion of a first energy delivery device having two electrodes through and out of an open distal tip of the cannula and within the inner cancellous bone region of the vertebral body,

wherein the two electrodes comprise a pair of bipolar electrodes,

wherein a first electrode of the pair of bipolar electrodes is configured to function as an active electrode,

wherein a second electrode of the pair of bipolar electrodes is configured to function as a return electrode;

positioning the first electrode on a first side of a basivertebral nerve within the cancellous bone region of the vertebral body and positioning the second electrode on a second side of the basivertebral nerve;

applying pulsed energy using the first energy delivery device by generating a sufficiently high voltage difference between the first electrode and the second electrode for a sufficient duration to the basivertebral nerve within the vertebral body to treat back pain,

wherein the high voltage difference is in the range from 50 to 1500 volts,

wherein the sufficient duration is between 5 minutes and 30 minutes, and

wherein the sufficiently high voltage difference produces a total heating zone having a diameter of at least 0.5 cm and a peak temperature of between 70 degrees Celsius and 90 degrees Celsius.

2. The method of claim 1 :

wherein the energy is sufficient to denervate the basivertebral nerve,

wherein the step of inserting the cannula through the outer cortical bone region comprises inserting a distal tip of a stylet through the cannula prior to insertion of the cannula such that the distal tip of the stylet punctures the outer cortical bone region, and

wherein the cannula and the stylet each have a curved distal end portion.

3. The method of claim 1 , wherein the energy is sufficient to permanently inhibit the basivertebral nerve.

4. The method of claim 1 , wherein the energy is sufficient to permanently ablate the basivertebral nerve.

5. The method of claim 1 , wherein the vertebral body is a vertebral body of a lumbar or sacral vertebra.

6. The method of claim 1 , further comprising:

inserting a distal end portion of a second energy delivery device having two electrodes within an inner cancellous bone region of a second vertebral body,

simultaneous with said applying pulsed energy using the first energy delivery device, applying pulsed energy using the second energy delivery device by generating a sufficiently high voltage difference between the two electrodes for a sufficient duration to a basivertebral nerve within the second vertebral body.

7. The method of claim 6 , wherein the applied pulsed energy using the first energy delivery device is sufficient to permanently ablate the basivertebral nerve within the first vertebral body, and wherein the applied pulsed energy using the second energy delivery device is sufficient to permanently ablate the basivertebral nerve within the second vertebral body.

8. A method of treating pain in a patient, the method comprising:

inserting a cannula through an outer cortical bone region of a bone and into an inner cancellous bone region of the bone;

inserting a distal end portion of an energy delivery device having two electrodes through and out of an open distal tip of the cannula and within the inner cancellous bone region of the bone,

positioning a first electrode of the two electrodes on a first side of an intraosseous nerve within the cancellous bone region of the bone and positioning a second electrode of the two electrodes on a second side of the intraosseous nerve; and

applying pulsed energy using the energy delivery device by generating a sufficiently high voltage difference between the first electrode and the second electrode for a sufficient duration to modify the intraosseous nerve within the bone,

wherein the high voltage difference is in the range from 50 to 1500 volts,

wherein the sufficient duration is between 5 minutes and 30 minutes, and

wherein the sufficiently high voltage difference produces a total heating zone having a diameter of at least 0.5 cm and a peak temperature of between 70 degrees Celsius and 90 degrees Celsius.

9. The method of claim 8 :

wherein the energy is sufficient to denervate the intraosseous nerve,

wherein the intraosseous nerve is a basivertebral nerve within a vertebral body,

wherein the step of inserting the cannula through the outer cortical bone region comprises inserting a distal tip of a stylet through the cannula prior to insertion of the cannula such that the distal tip of the stylet punctures the outer cortical bone region, and

wherein the stylet and the cannula each have a curved distal end portion.

10. The method of claim 8 , wherein the energy is sufficient to permanently inhibit the intraosseous nerve.

11. The method of claim 8 , wherein the energy is sufficient to denervate the intraosseous nerve.

12. The method of claim 8 , wherein the energy is sufficient to permanently ablate the intraosseous nerve.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 11, 2019
From: PELLEGRINO, RICHARD; PAPINEAU, PAULA; CROMBIE, JOHN S.; PATEL, SAMIT; RYAN, THOMAS
To: RELIEVANT MEDSYSTEMS, INC.
Reel/Frame 049736/0499 →
Continuity (6)
Continuation 15344284 · Nov 4, 2016
Continuation 14673172 · Mar 30, 2015
Continuation 13923798 · Jun 21, 2013
Continuation 13615300 · Sep 13, 2012
Continuation 13612541 · Sep 12, 2012
Related Publication 20190110833A1 · Apr 18, 2019
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