Electrosurgical generator

• US 10,111,703 B2
• Filed: 07/07/2014
• Issued: 10/30/2018
• Est. Priority Date: 05/06/2014
• Status: Active Grant

• Current Assignee: Cosman Instruments, LLC
• Original Assignee: Cosman Instruments, LLC
• Inventors: Cosman, Jr., Eric R., Cosman, Sr., Eric R.
• Primary Examiner(s): Peffley, Michael
• Application Number:
  US14/325,285
• Publication Number:
  US 20150320478A1
• Time in Patent Office: 1,576 Days
• CPC Class Codes: A61B 18/10 Power sources therefor
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1233 with circuits for assuring patient safety
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• CPC Class Codes: A61B 18/16 Indifferent or passive electrodes for grounding
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/0044 Spinal cord
• CPC Class Codes: A61B 2018/00446 Brain
• CPC Class Codes: A61B 2018/00494 Stomach, intestines or bowel
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00529 Liver
• CPC Class Codes: A61B 2018/00541 Lung or bronchi
• CPC Class Codes: A61B 2018/00565 Bone
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 : with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00648 : using more than one sensed parameter
• CPC Class Codes: A61B 2018/00654 : with individual control of each of a plurality of energy emitting elements
• CPC Class Codes: A61B 2018/00666 : using a threshold value
• CPC Class Codes: A61B 2018/00702 : Power or energy
• CPC Class Codes: A61B 2018/00708 : switching the power on or off
• CPC Class Codes: A61B 2018/00714 : Temperature
• CPC Class Codes: A61B 2018/0072 : Current
• CPC Class Codes: A61B 2018/00726 : Duty cycle
• CPC Class Codes: A61B 2018/00732 : Frequency
• CPC Class Codes: A61B 2018/00744 : Fluid flow
• CPC Class Codes: A61B 2018/00755 : Resistance or impedance
• CPC Class Codes: A61B 2018/00761 : Duration
• CPC Class Codes: A61B 2018/00767 : Voltage
• CPC Class Codes: A61B 2018/00779 : Power or energy
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00827 : Current
• CPC Class Codes: A61B 2018/00833 : Differential current
• CPC Class Codes: A61B 2018/00863 : Fluid flow
• CPC Class Codes: A61B 2018/00875 : Resistance or impedance
• CPC Class Codes: A61B 2018/00892 : Voltage
• CPC Class Codes: A61B 2018/124 : switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61B 2018/1253 : monopolar
• CPC Class Codes: A61B 2018/165 : Multiple indifferent electrodes
• CPC Class Codes: A61B 2018/1823 : Generators therefor
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61B 34/10 : Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 90/37 : Surgical systems with images on a monitor during operation
• CPC Class Codes: A61N 1/36017 : with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 : for treatment of pain

Abstract

This invention relates to high-frequency ablation of tissue in the body using a cooled high-frequency electrode connected to a high frequency generator including a computer graphic control system and an automatic controller for control the signal output from the generator, and adapted to display on a real time graphic display a measured parameter related to the ablation process and visually monitor the variation of the parameter of the signal output that is controlled by the controller during the ablation process. In one example, one or more measured parameters are displayed simultaneously to visually interpret the relation of their variation and values. In one example, the displayed one or more parameters can be taken from the list of measured voltage, current, power, impedance, electrode temperature, and tissue temperature related to the ablation process. The graphic display gives the clinician an instantaneous and intuitive feeling for the dynamics and stability of the ablation process for safety and control. This invention relates to monitoring and controlling multiple ground pads to optimally carry return currents during high-frequency tissue ablation, and to prevent of ground-pad skin burns. This invention relates to the use of ultrasound imaging intraoperatively during a tissue ablation procedure. This invention relates to the use of nerve stimulation and blocking during a tissue ablation procedure.

Claims

1. A system for tissue ablation that includes a radiofrequency generator, a radiofrequency ablation electrode, and a controller;

wherein the radiofrequency generator is configured to deliver a radiofrequency signal via the radiofrequency ablation electrode;

wherein the controller automatically produces a sequence of on periods and off periods;

wherein during each on period, the controller configures the signal level to heat tissue in order to increase the volume ablated tissue and to produce boiling in the tissue;

wherein during each off period, the controller configures the signal level to allow for cooling of heated tissue;

wherein the controller terminates an on period based in part on a measured indication of boiling in the tissue;

wherein after the signal is first configured to heat tissue in order to increase the volume ablated tissue, the controller configures both increases and decreases of the signal level delivered during on periods based in part on the duration of a present on period or of a previous on period.

2. The system of claim 1 wherein the radiofrequency ablation electrode is fluid-cooled.

3. The system of claim 1 wherein the duration of at least one on period or off period is 5 seconds or longer.

4. The system of claim 1 wherein the measured indication of boiling in the tissue is the electrode'"'"'s measured impedance exceeding an impedance threshold value.

5. The system of claim 1 wherein the measured indication of boiling in the tissue is a decrease in the electrode'"'"'s measured current or power while a voltage is applied to the electrode.

6. The system of claim 1 wherein the controller configures the duration of an off period to provide for dissipation of gaseous vapor formed by boiling within the tissue.

7. The system of claim 1 wherein the controller regulates a parameter of the signal level during each on period, wherein the parameter is selected from the list current, voltage, power.

8. The system of claim 1 wherein the controller automatically regulates a parameter of the signal level during each off period, wherein the parameter is selected from the list current, voltage, power.

9. The system of claim 1 wherein the controller increases the signal level during an on period.

10. The system of claim 9 wherein the controller increases the signal level in steps over time.

11. The system of claim 10 wherein the controller sets the initial signal level of an on period to be less than the final signal level of the latest preceding on period by an amount that is influenced by the duration of the final step in the signal level during the latest preceding on period.

12. The system of claim 10 wherein a step increase in the signal level during a first on period is reversed by the controller to set the initial signal level for the next on period, if the duration of the step increase is less than a threshold value.

13. The system of claim 9 wherein the controller increases the signal level as a smooth function of time after a delay of at least zero seconds.

14. The system of claim 9 wherein the controller sets the initial signal level of a first on period to be less than the final signal level of the last preceding on period, wherein the difference between the final signal level of the last preceding on period and the initial signal level of the first on period is influenced by the duration and degree of signal level increase during the last preceding on period.

15. The system of claim 1 wherein the signal level during a first on period is less than the signal level during a second on period, wherein the first on period comes before the second on period.

16. The system of claim 15 wherein the increase in signal level from the first on period to the second on period is influenced by the duration of the first on period.

17. The system of claim 1 wherein the controller sets the initial signal level of an on period to a value that is less than the final signal level of the latest preceding on period, wherein the value is influenced a parameter of the latest preceding on period.

18. The system of claim 1 wherein the controller sets the initial signal level of an on period to a value that is less than the final signal level of the latest preceding on period if the duration of the latest preceding on period is less than a threshold value.

19. The system of claim 1 wherein the increases and decreases in the signal level delivered during on periods are configured to maximize the volume ablated tissue.

20. The system of claim 1 wherein the increases and decreases in the signal level delivered during on periods are configured to produce intermittent boiling in the tissue, and to produce periods of tissue heating between instances of the boiling, wherein the periods of tissue heating are sufficiently long to increase the volume of heated tissue.

21. The system of claim 1 further including a first user setting that sets the initial signal level of the initial on period in the sequence, and a second user setting that sets the maximum signal level of all on periods in the sequence.

22. The system of claim 1 wherein the controller terminates an off period based in part on the duration of the off period.

23. The system of claim 1 wherein the controller configures changes in the duration of off periods based in part on measurements indicative of, or predictions about, the dissipation of gaseous vapor formed by boiling within the tissue.

24. The system of claim 22 wherein the controller increases the duration of the off periods monotonically as a function of the elapsed time of the sequence.

25. The system of claim 1 wherein the controller sets the duration of an off period as a function of a measurement of tissue temperature at a distance from the electrode active tip.

26. The system of claim 1 wherein the controller sets the duration of an off period as a function of an impedance measurement.

27. The system of claim 22 wherein the controller sets the duration of the off period as a function of the duration over which an impedance decreases from an elevated level induced by tissue heating during the previous on period.

28. The system of claim 1 wherein the measured indication of boiling in the tissue is the electrode'"'"'s measured temperature exceeding or substantially equaling 100°

C.