Thermal denervation devices and methods

• US 10,463,423 B2
• Filed: 10/05/2018
• Issued: 11/05/2019
• Est. Priority Date: 03/28/2003
• Status: Expired due to Fees

• Current Assignee: Relievant Medsystems, Incorporated (Boston Scientific Corporation)
• Original Assignee: Relievant Medsystems, Incorporated (Boston Scientific Corporation)
• Inventors: Sutton, Jeffrey K., Ryan, Thomas P., Patel, Samit, Pellegrino, Richard C.
• Primary Examiner(s): Roane, Aaron F
• Application Number:
  US16/153,407
• Publication Number:
  US 20190038343A1
• Time in Patent Office: 396 Days
• Field of Search: 606 48
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/148 having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2018/00071 Electrical conductivity
• CPC Class Codes: A61B 2018/0044 Spinal cord
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe

Abstract

A method and apparatus for treating an intraosseous nerve. The method includes positioning a hollow shaft through the cortical shell of a vertebral body and into a cancellous bone region of the vertebral body. The hollow shaft includes an annular wall having a longitudinal bore therein, a proximal portion and a distal portion, and a first window extending transversely through the annular wall. An electrosurgical probe is advanced within the longitudinal bore from the proximal portion toward the distal portion. The electrosurgical probe includes a first treatment element at a distal end of the probe, wherein the first treatment element being in electrical connection with a power supply. The first treatment element is slidably disposed within the longitudinal bore so that the first treatment element is advanced radially outward from the window and shaft to affect treatment of the intraosseous nerve within the cancellous bone region.

Claims

1. A method of treating an intraosseous nerve within a cancellous bone region of a vertebral body, comprising:

positioning a bipolar electrosurgical device through a cortical shell of a vertebral body and into a cancellous bone region of the vertebral body, wherein said electrosurgical device comprises an elongate shaft with a distal electrode on the elongate shaft and a proximal electrode spaced apart axially from the distal electrode on the elongate shaft, the distal and proximal electrodes forming a bipolar heating device, wherein each of the proximal electrode and the distal electrode is exposed to an outermost circumferential surface of the elongate shaft, wherein a distal edge of the proximal electrode is spaced between 2 mm and 25 mm from a proximal edge of the distal electrode, the elongate shaft further including a fluid delivery lumen extending therethrough, and a plurality of temperature sensors positioned along a distal end portion of the elongate shaft, wherein at least one of the plurality of temperature sensors is disposed between the proximal and distal electrodes;

heating an intraosseous nerve by applying a voltage between said distal and proximal electrodes to thereby heat at least a portion of the cancellous bone region of the vertebral body; and

delivering a cooling fluid to the fluid delivery lumen to cool at least one of the distal and proximal electrodes and maintain a temperature of the at least one of the distal and proximal electrodes at a desired temperature of less than 100°

C.,

wherein said heat is sufficient to denervate the intraosseous nerve within the vertebral body.

2. The method of claim 1, further comprising:

using a thermocouple to monitor a temperature within a heating zone produced by the bipolar heating device; and

maintaining the temperature within the heating zone within a desired temperature range.

3. The method of claim 1, further comprising using a thermocouple on the bipolar electrosurgical device to monitor a temperature within a heating zone produced by the bipolar heating device.

4. The method of claim 3, further comprising maintaining the temperature within the heating zone within a desired temperature range.

5. The method of claim 4, wherein maintaining the temperature within the heating zone within a desired temperature range comprise reducing a power input to the bipolar electrosurgical device.

6. The method of claim 1, wherein at least one of the temperature sensors of the bipolar electrosurgical device includes a thermocouple.

7. The method of claim 6, wherein the thermocouple extends through the fluid delivery lumen of the bipolar electrosurgical device.

8. The method of claim 6, wherein the thermocouple extends through an axial bore provided in the elongate shaft.

9. The method of claim 1, comprising modulating power to the bipolar electrosurgical device to control a temperature at the distal end of the elongate shaft.

10. A method of treating a vertebral body, comprising:

positioning a bipolar electrosurgical device through a cortical shell of a vertebral body and into a cancellous bone region of the vertebral body, wherein said electrosurgical device comprises an elongate shaft with a distal electrode on the elongate shaft and a proximal electrode spaced apart axially from the distal electrode on the elongate shaft by electrically insulating material, wherein a distal edge of the proximal electrode is spaced between 2 mm and 25 mm from a proximal edge of the distal electrode, the distal and proximal electrodes forming a bipolar heating device, wherein each of the proximal electrode and the distal electrode is exposed to an outermost circumferential surface of the elongate shaft, the elongate shaft further including a fluid delivery lumen extending therethrough, and at least one temperature sensor disposed along the distal end portion of the elongate shaft to monitor temperature of the device at various locations;

heating an intraosseous nerve by applying a voltage between said distal and proximal electrodes to thereby heat at least a portion of the cancellous bone region of the vertebral body; and

delivering a cooling fluid to the fluid delivery lumen to cool at least one of the distal and proximal electrodes,

wherein said heat is sufficient to treat the vertebral body.

11. The method of claim 10, further comprising:

using a thermocouple to monitor a temperature within a heating zone produced by the bipolar heating device; and

maintaining the temperature within the heating zone within a desired temperature range, and

wherein the vertebral body includes a tumor.

12. The method of claim 10, wherein the vertebral body includes at least one tumor.

13. The method of claim 12, wherein the heat is sufficient to treat the at least one tumor.

14. The method of claim 10, further comprising using a thermocouple of the at least one temperature sensor to monitor a temperature within a heating zone produced by the bipolar heating device.

15. The method of claim 14, further comprising maintaining the temperature within the heating zone within a desired temperature range.

16. The method of claim 15, wherein maintaining the temperature within the heating zone within a desired temperature range comprise reducing a power input to the bipolar electrosurgical device.

17. The method of claim 10, wherein the at least one temperature sensor of the bipolar electrosurgical device includes a thermocouple.

18. The method of claim 17, wherein the thermocouple extends through the fluid delivery lumen of the bipolar electrosurgical device.

19. The method of claim 18, wherein the thermocouple extends through an axial bore provided in the elongate shaft.

20. The method of claim 10, further comprising modulating power to the bipolar electrosurgical device to control a temperature at the distal end of the elongate shaft.