Electrosurgical generator

• US 10,342,606 B2
• Filed: 07/07/2014
• Issued: 07/09/2019
• Est. Priority Date: 05/06/2014
• Status: Active Grant

• Current Assignee: Cosman Instruments, LLC
• Original Assignee: Cosman Instruments, LLC
• Inventors: Cosman, Eric R.
• Primary Examiner(s): Peffley, Michael F
• Application Number:
  US14/325,295
• Publication Number:
  US 20150320480A1
• Time in Patent Office: 1,828 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 including:

a generator of high-frequency electrical signal output;

an electrode including an shaft portion adapted to be inserted into a body and adapted to be connected to the generator, the shaft portion having a tip portion so adapted such that when said shaft portion is inserted into the body, the signal output is delivered through the tip portion to the bodily tissue to be ablated, said shaft portion having an inner space that can accept circulation of a coolant to cool said tip portion;

a coolant system adapted to connect to said electrode and supply circulation of the coolant to the electrode inner space to cool the electrode tip portion;

a measuring system adapted to measure in real time at least two signal output parameters from the list of impedance, current, voltage, and power;

a control system including an automatic controller adapted to control at least one of the measured signal output parameters, including modulating the signal output to maintain the controlled signal output parameter at a desired level, wherein the control system repeatedly switches the level of the signal output between an ablation range configured to heat tissue substantially, and a cooling range configured to allow for cooling of the heated tissue, wherein the control system performs the switching in response to the controlled signal output parameter in accordance with the automatic controller; and

a computer graphic display adapted to plot in real time the controlled signal output parameter and at least one other measured signal output parameter on the same time scale axis.

2. The system of claim 1 wherein the plotting is configured to provide a dynamic visual relationship of the variation of these signal output parameters.

3. The system of claim 1 wherein the control system alternately switches the level of the signal output between an ablation range configured to provide for substantial tissue heating, and a cooling range configured to provide for tissue cooling, and thereby produces a sequence of signal output levels configured to maintain the controlled signal output parameter in a desired range, in accordance with the automatic controller.

4. The system of claim 1 wherein the control system produces a sequence of up times and down times;

wherein during each up time, the signal output level is set to a high level configured to raise tissue temperatures substantially;

wherein during each down time, the signal output level is set to a low level configured to allow for cooling of tissue cool that was heated into the boiling range; and

wherein the control system, according to the automatic controller, stabilizes the duration of the up times, the duration of down times, and the signal output level during the up times to achieve a desired ablation size for a prescribed total duration of the ablation process.

5. The system of claim 4 wherein during each up time, the signal output is on;

and wherein during each down time, the signal output is off.

6. The system of claim 4 wherein the durations of the up times and the durations of the down times are each stabilized to a value in the range 5 to 40 seconds.

7. The system of claim 1 wherein the control system, by means of the automatic controller, begins the process of abating tissue by means of the electrode by automatically ramping up the signal output level until one of the signal output parameters reaches a prescribed level, and then the control system continues the process of ablating tissue by automatically modulating the signal output level according to the automatic controller to maintain the controlled signal output parameter at desired levels to optimize ablation size.

8. The system of claim 1 wherein the tip portion contains a temperature sensor;

wherein the measuring system includes a temperature measuring system adapted to connect to the temperature sensor and to produce a temperature signal indicative of the temperature in the tip portion;

wherein the computer graphic display is adapted to plot the temperature signal in real time on the same time scale axis.

9. The system of claim 1 wherein the controlled signal output parameter is impedance and the other plotted signal output parameter is selected from the list current, power, and voltage.

10. The system of claim 9 wherein the graphic display parameters is color-coded so the parameters can be easily visually differentiated from each other.

11. The system of claim 1 wherein the range of the time scale axis is at least 720 seconds.

12. The system of claim 1 wherein if one of the displayed signal output parameters is impedance, then the range of the impedance measurement includes at least the range 40 to 120 ohms.

13. The system of claim 1 wherein if one of the displayed signal output parameters is current, then the range of said current output measurement includes at least the range 0 to 2000 mA.

14. The system of claim 1 wherein the generator can produce more than 50 Watts of high-frequency signal output.

15. The system of claim 1 wherein the generator can produce at least 200 Watts of high-frequency signal output.

16. The system of claim 1 wherein the generator can produce at least 400 Watts of high-frequency signal output.

17. The system of claim 1 wherein the generator is configured for tumor ablation.

18. A system for tissue ablation that includes a radiofrequency generator, a controller, and a graphic display, wherein the radiofrequency generator is configured to apply a radiofrequency signal to an ablation electrode that is in contact with bodily tissue;

wherein the controller is configured to automatically alternate the signal level between a first range configured to heat tissue, and a second range configured to allow for cooling of heated tissue;

wherein the controller switches the signal level from the first range to the second range based in whole or in part on an indication of boiling or impending boiling in tissue heated by the ablation electrode, and wherein the controller switches the signal level from the second range to the first range after a duration configured to allow for dissipation of gas bubbles formed in the tissue due to boiling, wherein the controller automatically performs the switching;

wherein the graphic display is configured plot in real time and on one time axis, two or more different types of parameters of the signal delivered to the ablation electrode;

wherein each parameter is selected from the list;

impedance;

voltage;

current;

power;

a measurement of the signal;

mathematical functions taking one or more of the arguments impedance, voltage, current, power, and a measurement of the signal.

19. The system of claim 18 wherein the controller changes the signal level from the first range to the second range based in whole or in part on an increase in a measured impedance.

20. The system of claim 18 wherein one of the plotted parameters is impedance, one of the plotted parameters is current, and the first range is a range of radiofrequency current levels.

21. The system of claim 18 wherein the controller changes the signal level from the first range to the second range based in whole or in part on a change in one or more measured parameters in the list voltage, current, power.

22. The system of claim 18 wherein the controller changes the signal level from the second range to the first range based on in whole or in part a measured impedance.

23. The system of claim 18 wherein the ablation electrode is internally-cooled and the controller is configured to optimize a parameter of tissue heating by the ablation electrode.

24. The system of claim 18 wherein the ablation electrode is internally-cooled and the controller is configured to maximize the volume of tissue heated by the internally-cooled ablation electrode.

25. The system of claim 18 wherein the first range is a range of signal levels of one type, wherein the type is selected from the list current, power, voltage.

26. The system of claim 18 wherein the first range is a range radiofrequency current values.

27. The system of claim 18 wherein the ablation electrode is internally-cooled.

28. The system of claim 18 wherein the ablation electrode is not internally-cooled.

29. The system of claim 18 wherein the ablation electrode includes a temperature sensor.

30. The system of claim 18 wherein the ablation electrode does not include a temperature sensor.

31. The system of claim 18 wherein one of the plotted parameters is impedance.

32. The system of claim 18 wherein one of the plotted parameters is current.

33. The system of claim 18 wherein one of the plotted parameters is impedance, and one of the plotted parameters is current.

34. The system of claim 18 wherein the graphic display is further configured to plot a temperature of the ablation electrode in real time on the time axis.

35. The system of claim 18 wherein one of the plotted parameters is impedance, one of the plotted parameters is current, and the graphic display is further configured to plot a temperature of the ablation electrode in real time on the time axis.

36. The system of claim 18 wherein the graphic display is further configured to plot a temperature measured at a distance from the ablation electrode.

37. The system of claim 18 and further including a controller that can automatically regulate the signal level delivered to the ablation electrode, wherein the signal level is a parameter of the signal selected from the list:

impedance;

voltage;

current;

power;

a measurement of the signal;

a mathematical function taking one or more of the arguments impedance, voltage, current, power, and a measurement of the signal.

38. The system of claim 18 wherein the radiofrequency generator delivers one or more radiofrequency signals to one or more ablation electrodes, and for each ablation electrode, the graphic display plots in real time and on a time axis, two or more parameters of the signal delivered to the ablation electrode;

wherein each parameter is selected from the list;

impedance;

voltage;

current;

power;

a measurement of the signal delivered to the ablation electrode;

mathematical functions taking one or more of the arguments impedance, voltage, current, power, and a measurement of the signal delivered to the ablation electrode.

39. The system of claim 38 wherein the graphic display positions all the plots of more than one electrode on the same time axis.

40. The system of claim 38 wherein the graphic display includes a different time axis for the plots of each of the one or more ablation electrodes.

41. The system of claim 18 and further including numerical display of the duration of each instance of the signal level being in the first range, each instance of the signal level being in the second range, or both.

42. The system of claim 18 and further including numerical display of the two or more parameters.

43. The system of claim 18 further including a numerical display of each instance of the signal being in the first range and of each instance of the signal being in the second range.

44. A system for tissue ablation that includes a radiofrequency generator;

a controller;

a graphic display;

an electrode configured to be inserted into bodily tissue; and

a coolant configured to be supplied to, and to thereby to cool, the electrode;

wherein the radiofrequency generator is configured to deliver a radiofrequency signal output to the electrode when inserted into bodily tissue;

wherein the controller automatically alternates between a first state and a second state;

wherein in the first state, the controller maintains the signal output at a higher level configured to raise the temperature of a substantial portion of the bodily tissue to a destructive temperature;

wherein in the second state, the controller maintains the signal output at a lower level configured to allow the temperature of heated bodily tissue to cool substantially;

wherein the controller switches from the first state to the second state when a measurement indicates the presence of high-temperature vapor in the tissue near the electrode;

wherein the duration for which the controller remains in the second state before switching to the first state is configured to provide for dissipation of high-temperature vapor in the tissue near the electrode, wherein the controller automatically performs the switching;

wherein the graphic display plots one or more parameters as a function of time;

wherein each parameter can be selected from the list impedance, current, power, voltage, duty cycle, temperature, time, a signal output level, a measurement of the signal output, a parameter of the signal output, a time average of a parameter of the signal output, the RMS value of a parameter of the signal output over a time window, a mathematical function of one or more parameters of the signal output.

45. The system of claim 44 wherein the controller switches from the first state to the second state in response to a change in a measured impedance.

46. The system of claim 44 wherein the controller prevents switching from the second state to the first state unless an elevated impedance decreases to a lower value.

47. The system of claim 44 wherein the higher level is an RF current level or a range of RF current levels.

48. The system of claim 44 wherein the higher level is an RF power level or a range of RF power levels.

49. The system of claim 44 wherein the higher level is an RF voltage level or a range of RF voltage levels.

50. The system of claim 44 wherein the duration of an instance of the first state or of an instance of the second state is greater than 5 seconds.

51. The system of claim 44 further including at least one numerical display selected from the list:

the duration of the controller'"'"'s being in an instance of the first state, the duration of the controller'"'"'s being in an instance of the second state.

52. The system of claim 44 wherein the graphic display plots the impedance and the current of the signal output on the same time axis.