IP Library Granted Patent US 11,737,814
Granted Patent B2
US 11,737,814 · App. 16/818,092 · Granted Aug 29, 2023

Cryotherapy treatment for back pain

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.
A61B18/1487A61B17/3472A61B18/148A61B18/1492A61B18/18A61N5/00A61B17/320068A61B17/8805A61B17/8819A61B18/02A61B18/082A61B18/1206A61B18/16A61B18/1815A61B18/20A61B18/22A61B2017/00261A61B2017/00331A61B2017/00867A61B2018/00017A61B2018/0044A61B2018/0072A61B2018/00339A61B2018/00434A61B2018/00565A61B2018/00577A61B2018/00589A61B2018/00642A61B2018/00761A61B2018/00791A61B2018/00821A61B2018/126A61B2018/1425A61B2018/1807A61B2018/2005A61B2034/301A61B2090/374A61B2218/002A61N1/0551A61N7/00
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Quick Facts
Patent No.
US 11,737,814
App. No.
16/818,092
Granted
Aug 29, 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 (e.g., an energy delivery device).

Claims (54)

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

inserting a cryotherapy device within a vertebral body,

wherein the vertebral body is a vertebral body of a lumbar vertebra or a sacral vertebra;

applying cooling at a target treatment location within the vertebral body using the cryotherapy device,

wherein the target treatment location comprises a portion of a basivertebral nerve,

wherein the cooling is configured to provide localized treatment sufficient to disrupt transmission of pain signals along the portion of the basivertebral nerve,

wherein the cooling comprises use of liquid nitrous oxide,

wherein the cooling is configured to cool tissue of the target treatment location within the vertebral body to a temperature of between −20 and −40 degrees Celsius wherein the temperature is maintained for 5 to 20 minutes, and

wherein the cooling is delivered in one or more freeze cycles; and

performing diagnostic stimulation of the portion of the basivertebral nerve within the vertebral body.

2. The method of claim 1 :

wherein the vertebral body is a vertebral body of an L5 vertebra or an S1 vertebra,

wherein the cooling is sufficient to permanently disrupt transmission of pain signals along the portion of the basivertebral nerve,

wherein inserting the cryotherapy device within the vertebral body comprises inserting the cryotherapy device through an introducer previously inserted within the vertebral body,

wherein the method further comprises performing imaging prior to inserting the cryotherapy device to identify the target treatment location within the vertebral body, and

wherein the method further comprises removing the cryotherapy device from the vertebral body.

3. The method of claim 1 , wherein the cooling is sufficient to permanently disrupt transmission of pain signals along the portion of the basivertebral nerve.

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

5. The method of claim 1 , wherein the cooling is delivered in two or more freeze cycles, and wherein the freeze cycles comprise freeze-thaw cycles.

6. A method of treating back pain, the method comprising:

inserting a cryotherapy device within a vertebral body,

applying cooling at a target treatment location within the vertebral body using the cryotherapy device,

wherein the target treatment location comprises a portion of a basivertebral nerve,

wherein the cooling is configured to provide localized treatment sufficient to disrupt transmission of pain signals along the portion of the basivertebral nerve,

wherein the cooling is configured to cool tissue of the target treatment location within the vertebral body to a temperature of between −20 and −80 degrees Celsius, and

wherein the cooling is delivered in two or more freeze-thaw cycles; and

performing diagnostic stimulation of the portion of the basivertebral nerve within the vertebral body.

7. The method of claim 6 :

wherein the vertebral body is a vertebral body of an L5 vertebra or an S1 vertebra,

wherein the cooling is sufficient to permanently disrupt transmission of pain signals along the portion of the basivertebral nerve,

wherein inserting the cryotherapy device within the vertebral body comprises inserting the cryotherapy device through an introducer previously inserted within the vertebral body, and

wherein the method further comprises removing the cryotherapy device from the vertebral body.

8. The method of claim 6 , wherein the cooling comprises circulating fluid within one or more lumens of the cryotherapy device.

9. The method of claim 6 , wherein the temperature is between −20 and −50 degrees Celsius.

10. The method of claim 6 , wherein the temperature is between −20 and −40 degrees Celsius.

11. The method of claim 6 , further comprising performing imaging prior to inserting the cryotherapy device to identify the target treatment location within the vertebral body.

12. The method of claim 6 , wherein the cooling comprises use of liquid nitrous oxide.

13. A method of treating back pain, the method comprising:

inserting a cryotherapy device to a location of a vertebral body,

applying cooling to a portion of a basivertebral nerve associated with the vertebral body using the cryotherapy device,

wherein the cooling is configured to provide localized treatment sufficient to disrupt transmission of pain signals along the portion of the basivertebral nerve,

wherein the cooling is configured to cool the portion of the basivertebral nerve to a temperature of between −20 and −80 degrees Celsius, and

wherein the cooling is delivered in two or more freeze-thaw cycles.

14. The method of claim 13 :

wherein the vertebral body is a vertebral body of an L5 vertebra or an S1 vertebra,

wherein the cooling is sufficient to permanently disrupt transmission of pain signals along the portion of the basivertebral nerve,

wherein the temperature is between −20 and −40 degrees Celsius, and

wherein inserting the cryotherapy device to a location of the vertebral body comprises inserting the cryotherapy device within the vertebral body.

15. The method of claim 14 , further comprising performing imaging prior to inserting the cryotherapy device to identify the location of the vertebral body.

16. The method of claim 13 , further comprising performing diagnostic stimulation of the portion of the basivertebral nerve.

17. The method of claim 13 , wherein the cooling comprises circulating fluid within one or more lumens of the cryotherapy device.

18. The method of claim 13 , wherein the temperature is between −20 and −50 degrees Celsius.

19. The method of claim 13 , wherein the temperature is between −20 and −40 degrees Celsius.

20. The method of claim 13 , wherein the cooling comprises use of liquid nitrous oxide.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 10, 2020
From: PELLEGRINO, RICHARD; PAPINEAU, PAULA; CROMBIE, JOHN S.; PATEL, SAMIT; RYAN, THOMAS
To: RELIEVANT MEDSYSTEMS, INC.
Reel/Frame 053181/0529 →
Continuity (7)
Continuation 16153242 · Oct 5, 2018
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 20200281646A1 · Sep 10, 2020