Granted Patent B2

US 12,496,094 · App. 17/645,658 · Granted Dec 16, 2025

Inventors: Brian W. Donovan (San Jose, CA); Samit Patel (Palo Alto, CA); Ray M. Baker (San Clemente, CA)

Assignee: Relievant Medsystems, Inc.

A61B17/3423A61B17/1633A61B17/1671A61B17/3472A61B18/082A61B18/1206A61B18/148A61B18/1482A61B18/16A61B34/20A61B2017/00867A61B2017/3445A61B2018/0044A61B2018/00577A61B2018/00714A61B2018/00732A61B2018/00982A61B2018/00994A61B2018/126A61B2018/162A61B34/30A61B2090/374A61B2090/3762

Abstract

Claims (37)

1 . A method of detecting and treating back pain of a subject, the method comprising:

identifying a candidate vertebral body from a plurality of vertebral bodies of the subject for treatment based on a determination that the candidate vertebral body exhibits one or more symptoms associated with vertebral endplate degeneration or defects,

wherein the determination is based on obtaining one or more biomarkers from the subject,

wherein the one or more biomarkers correlate with pathophysiological processes associated with vertebral endplate degeneration or defects,

wherein the one or more biomarkers are obtained from at least one tissue or fluid source comprising plasma, serum, or synovial fluid; and

ablating a basivertebral nerve within the identified candidate vertebral body by applying a thermal treatment dose to a location within the vertebral body of at least a minimum threshold of 240 cumulative equivalent minute (“CEM”) using a CEM at 43 degrees Celsius model sufficient to ablate the basivertebral nerve, wherein the location of the applied thermal treatment dose is in a desired treatment location within the vertebral body, wherein infrared sensing techniques are performed to confirm the thermal treatment dose is in the desired treatment location within the vertebral body, wherein the infrared sensing techniques comprise thermal mapping using multiple thermocouples positioned at different locations within the vertebral body to generate a graphical visualization, wherein the graphical visualization is displayed on a graphical user interface and overlaid on top of actual anatomical images of the vertebral body.

2 . The method of claim 1 , wherein:

the pathophysiological processes include pre-Modic change characteristics and further wherein the one or more biomarkers correlate to the pre-Modic change characteristics prior to manifestation of Modic changes;

the one or more biomarkers are obtained using medical imaging techniques, and

applying the thermal treatment dose comprises applying radiofrequency energy to the location within the vertebral body sufficient to ablate the basivertebral nerve using a radiofrequency energy delivery device.

3 . The method of claim 1 , wherein the pathophysiological processes include pre-Modic change characteristics and further wherein the one or more biomarkers correlate to the pre-Modic change characteristics prior to manifestation of Modic changes.

4 . The method of claim 1 , wherein the one or more biomarkers are obtained from using medical imaging techniques.

5 . The method of claim 1 , wherein the one or more biomarkers are obtained using spectroscopy techniques.

6 . The method of claim 1 , wherein the one or more biomarkers are obtained from the at least one tissue or fluid source comprising plasma, serum, or synovial fluid, wherein the at least one tissue or fluid source further comprises one or more intervertebral discs or the plurality of vertebral bodies.

7 . The method of claim 1 , wherein the one or more symptoms include bone marrow lesions or fibrosis.

8 . The method of claim 1 , wherein the one or more biomarkers are obtained from a location within or adjacent the vertebral body.

9 . The method of claim 1 , wherein the one or more biomarkers are obtained from the at least one tissue or fluid source comprising plasma, serum, or synovial fluid, wherein the at least one tissue or fluid source further comprises cerebrospinal fluid adjacent the vertebral body of the subject.

10 . The method of claim 1 , wherein the one or more biomarkers are obtained over an extended period of time.

11 . The method of claim 1 , wherein applying the thermal treatment dose comprises applying radiofrequency energy to the location within the vertebral body sufficient to ablate the basivertebral nerve using a radiofrequency energy delivery device.

12 . The method of claim 1 , wherein applying the thermal treatment dose comprises applying ultrasound energy to the location within the vertebral body sufficient to ablate the basivertebral nerve using an ultrasound energy delivery device.

13 . The method of claim 1 , wherein applying the thermal treatment dose comprises applying microwave energy to the location within the vertebral body sufficient to ablate the basivertebral nerve using a microwave energy delivery device.

14 . A method of detecting and treating back pain of a subject, the method comprising:

identifying a candidate vertebral body from a plurality of vertebral bodies of the subject for treatment based on a determination that the candidate vertebral body exhibits one or more symptoms associated with vertebral endplate degeneration or defects, all of which may be considered pre-Modic change characteristics,

wherein the one or more symptoms include bone marrow lesions or fibrosis,

wherein the determination is based on obtaining one or more biomarkers from the subject,

wherein the one or more biomarkers correlate with pathophysiological processes associated with vertebral endplate degeneration or defects;

wherein the one or more biomarkers are obtained from at least one tissue or fluid source comprising plasma, serum, or synovial fluid; and

ablating one or more intraosseous nerves within the identified candidate vertebral body by applying a thermal treatment dose to a location within the vertebral body of at least a minimum threshold of 240 cumulative equivalent minute (“CEM”) using a CEM at 43 degrees Celsius model sufficient to ablate the basivertebral nerve, wherein the location of the applied thermal treatment dose is in a desired treatment location within the vertebral body, wherein infrared sensing techniques are performed to confirm the thermal treatment dose is in the desired treatment location within the vertebral body, wherein the infrared sensing techniques comprise thermal mapping using multiple thermocouples positioned at different locations within the vertebral body to generate a graphical visualization, wherein the graphical visualization is displayed on a graphical user interface and overlaid on top of actual anatomical images of the vertebral body.

15 . The method of claim 14 , wherein:

the pathophysiological processes include pre-Modic change characteristics and further wherein the one or more biomarkers correlate to the pre-Modic change characteristics prior to manifestation of Modic changes;

the one or more biomarkers are obtained using medical imaging techniques, and

applying the thermal treatment dose comprises applying radiofrequency energy to the location within the vertebral body sufficient to ablate the one or more intraosseous nerves using a radiofrequency energy delivery device.

16 . The method of claim 14 , wherein the one or more biomarkers are obtained using spectroscopy techniques.

17 . The method of claim 14 , wherein the one or more biomarkers are obtained from the at least one tissue or fluid source comprising plasma, serum, or synovial fluid, wherein the at least one tissue or fluid source further comprises one or more intervertebral discs or the plurality of vertebral bodies.

18 . The method of claim 14 , wherein the one or more biomarkers are obtained from one or more blood serum samples.

19 . The method of claim 14 , wherein the one or more biomarkers comprise pain indicators, cytokines, edema factors, and/or inflammatory factors.

20 . The method of claim 14 , wherein the one or more biomarkers are selected from the group consisting of: substance P, inflammatory cytokines, calcitonin gene-related peptides, heat shock proteins, and high-sensitivity C-reactive proteins.

Assignments (1)

Continuity (4)

References Cited (400)