Granted Patent B1

US 12,433,668 · App. 18/053,284 · Granted Oct 7, 2025

Inventors: Brian W. Donovan (San Jose, CA); Alexander Pruitt (San Jose, CA)

Assignee: Relievant Medsystems, Inc.

A61B18/148A61B2018/00434A61B2018/00577A61B2018/00702A61B2018/00714A61B2018/00732A61B2018/00755A61B2018/00761A61B2018/00791A61B2018/126

Abstract

Claims (37)

1. A radiofrequency tissue ablation system configured to reduce occurrences of impedance-related stoppages of radiofrequency energy delivery during a radiofrequency tissue ablation procedure, the system comprising:

a radiofrequency probe comprising one or more electrodes and one or more temperature sensors;

a radiofrequency generator comprising a power source electrically coupled to the one or more electrodes and one or more processors operatively coupled to the power source and to the one or more temperature sensors,

wherein the one or more processors are configured to execute program instructions stored in memory of the radiofrequency generator that, when executed:

cause the power source to deliver radiofrequency energy to the one or more electrodes, the radiofrequency energy being sufficient to provide controlled heating of tissue surrounding the one or more electrodes; and

cause the radiofrequency generator to transition between a steady-state phase of operation and an impedance-limiting phase of operation so as to reduce temperature and tissue impedance prior to initiation of an automated impedance-related stoppage of radiofrequency energy delivery during a radiofrequency tissue ablation procedure,

when operating in the steady-state phase, the one or more processors are configured to:

receive temperature measurements from the one or more temperature sensors;

calculate a magnitude and a rate of change of tissue impedance based on signals received from the one or more electrodes; and

automatically transition to the impedance-limiting phase of operation when one or more trigger criteria are met; and

when in the impedance-limiting phase of operation, the one or more processors are configured to:

cause the power source to temporarily reduce power output to reduce temperature to a lower threshold temperature and to ramp power output back up after achieving the lower threshold temperature.

2. The system of claim 1 , wherein the radiofrequency probe comprises two electrodes positioned along a distal end portion of the radiofrequency probe configured to operate as a bipolar pair of electrodes.

3. The system of claim 2 , wherein the radiofrequency energy has a frequency between 400 kHz and 600 kHz and is applied for a duration sufficient to generate a controlled ablation zone to ablate tissue within the controlled ablation zone.

4. The system of claim 3 , wherein the duration is between 5 minutes and 15 minutes.

5. The system of claim 4 , wherein the ablated tissue comprises a basivertebral nerve within a vertebral body.

6. The system of claim 1 , wherein the signals received from the one or more electrodes are received at a certain interval, and wherein the interval is between 5 ms and 100 ms.

7. The system of claim 1 , wherein the calculation of the rate of change of tissue impedance involves calculation of a rolling average of tissue impedance measurements over a particular time duration.

8. The system of claim 7 , wherein the particular time duration is between 5 ms and 20,000 ms.

9. The system of claim 1 , wherein the one or more trigger criteria include at least one criterion based on temperature and at least one criterion based on the rate of change of tissue impedance.

10. The system of claim 9 , wherein the one or more trigger criteria include a predetermined upper threshold rate of change of tissue impedance.

11. The system of claim 10 , wherein the one or more trigger criteria have to be met for a certain number of data points or for a certain duration of time before the transition to the impedance-limiting phase of operation.

12. The system of claim 11 , wherein the certain number of data points is between 1 and 50.

13. The system of claim 11 , wherein the certain duration of time is between 5 ms and 5000 ms.

14. The system of claim 1 , wherein the power output is reduced until the lower threshold temperature is reached.

15. The system of claim 14 , wherein, when in the impedance-limiting phase of operation, the one or more processors are configured to cause the temperature to remain at the lower threshold temperature for a dwell period and wherein the ramp up in power does not occur until after the dwell period has passed.

16. The system of claim 15 , wherein the one or more processors are configured to transition the radiofrequency generator back to the steady-state phase of operation after a pre-set target temperature has been reached following the ramp up in power.

17. A computer-implemented method to reduce occurrences of impedance-related stoppages of radiofrequency energy delivery by a radiofrequency generator during a radiofrequency tissue ablation procedure, the method comprising executing stored program instructions via one or more hardware processors to:

cause the generator to operate in a steady-state phase of operation after an initial ramp up of power output, wherein when operating in the steady-state phase, the one or more hardware processors are configured to:

deliver radiofrequency energy to one or more electrodes of a radiofrequency probe sufficient to generate a controlled heating zone sufficient to ablate tissue surrounding the one or more electrodes;

continuously receive temperature measurements from one or more temperature sensors positioned along the radiofrequency probe; and

calculate a magnitude and a rate of change of tissue impedance based on signals received from the one or more electrodes; and

cause the generator to automatically transition to an impedance-limiting phase of operation when one or more trigger criteria are met based, at least in part, on the temperature measurements and/or the rate of change of tissue impedance, wherein, when operating in the impedance-limiting phase, the one or more hardware processors are configured to:

cause the generator to temporarily reduce power output to reduce temperature to a lower threshold temperature and then to ramp power output back up after the lower threshold temperature has been maintained for a certain time duration.

18. The method of claim 17 , wherein the wherein the calculation of the rate of change of tissue impedance involves calculation of a rolling average of tissue impedance measurements over a particular time duration.

19. The method of claim 17 , wherein the one or more trigger criteria comprise a predetermined upper threshold value for temperature and a predetermined upper threshold value for rate of change of tissue impedance.

20. The method of claim 17 , further comprising executing stored program instructions via one or more hardware processors to cause the generator to transition back to the steady-state phase of operation after a set target temperature has been reached following ramping of the power output back up after temperature maintenance at the lower threshold temperature.

Assignments (1)

Continuity (1)

References Cited (400)