Method and system for controlling an output of a radio-frequency medical generator having an impedance based control algorithm

• US 8,663,214 B2
• Filed: 01/24/2007
• Issued: 03/04/2014
• Est. Priority Date: 01/24/2006
• Status: Active Grant

• Current Assignee: Covidien AG (Medtronic Plc)
• Original Assignee: Covidien AG (Medtronic Plc)
• Inventors: Weinberg, Craig, Leidich, Kari
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US11/657,173
• Publication Number:
  US 20070173805A1
• Time in Patent Office: 2,596 Days
• Field of Search: 606 32- 42
• US Class Current: 606/34
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1233 with circuits for assuring patient safety
• CPC Class Codes: A61B 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00726 Duty cycle
• CPC Class Codes: A61B 2018/00767 Voltage
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00827 Current
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00892 Voltage

Abstract

A system for performing an electrosurgical procedure at a surgical site is disclosed. The system includes a sensor configured to continually sense an electrical and/or a physical property of tissue at a surgical site and to generate a sensor signal as a function thereof. The system also includes a control module configured to process the sensor signal using a processor, an algorithm, and a map having one or more predetermined values. The control module is further configured to compare the sensor signal to a predetermined level to determine reliability of the sensor signal and to signal an electrosurgical generator in response to a reliable sensor signal such that the electrosurgical generator enters energy control mode, wherein the electrosurgical generator matches an output of the control signal with a predetermined value from the map.

Claims

1. A system for performing an electrosurgical procedure at a surgical site, the system comprising:

a sensor configured to continually sense at least one of an electrical and physical property of tissue at a surgical site and to generate a sensor signal as a function thereof; and

a control module configured to process the sensor signal using a processor, a control algorithm, and a map having at least one predetermined value, the control module further configured to compare the sensor signal to a predetermined level to determine reliability of the sensor signal and to provide a control signal to an electrosurgical generator in response to a reliable sensor signal such that the electrosurgical generator enters energy control mode, during which the electrosurgical generator matches an output of the control signal with a predetermined value from the map and the control module determines whether a tissue reactance is stable by monitoring whether tissue impedance dwells below a predetermined threshold for a predetermined period of time;

wherein the control module (i) distinguishes between reliable and unreliable parameter data and (ii) is prevented from inputting unreliable initial parameter data to the control algorithm, the unreliable initial parameter data defined as parameters having values above predetermined maximum values or below predetermined minimum values.

2. A system according to claim 1, wherein the control module compares the sensor signal to a predetermined level and determines the reliability of the sensor signal at an initial operation of the system.

3. A system according to claim 1, wherein at least one parameter of the map is recalculated based in part on a control signal derived from a reliable sensor signal.

4. A system according to claim 1, wherein during the energy control mode the electrosurgical generator is configured to adjust a parameter selected from the group consisting of a voltage adjustment, a current adjustment, a pulse width adjustment, a pulse frequency adjustment, an amplitude adjustment, a crest factor adjustment, a duty cycle adjustment, a repetition rate adjustment, a waveform shape adjustment, and a wave adjustment.

5. A system according to claim 1, further comprising a user interface which is configured to allow a user to select a surgical parameter selected from the group consisting of a type of instrument being connected to the generator, a tissue type, and a desired surgical effect.

6. A system according to claim 1, wherein the control module determines an impedance from the sensor signal, and wherein the control module is configured to compare the impedance to a predetermined level to verify the tissue reactance, wherein once reactance is verified the control signal is configured to reference a stored value corresponding to the impedance from the map, and wherein the control module is configured to control the generator based in part on the stored value.

7. A system according to claim 6, wherein the stored value is a preset slope trajectory of a change of the impedance per unit of time.

8. A system according to claim 6, wherein the stored value is derived from past stored data recorded in a memory.

9. A system according to claim 6, wherein the stored value is a change in impedance over time from the map.

10. A system according to claim 6, wherein if the impedance drops below a predetermined threshold over a predetermined period of time, the control module disregards the measured impedance, and the control module thereafter continues to sense whether the tissue reactance occurs.

11. A system according to claim 6, wherein the control module disregards the impedance when no tissue reactance is determined.

12. A system according to claim 1, wherein the sensor is selected from the group consisting of a voltage sensor, a current sensor, a temperature sensor, an RMS voltage sensor, an RMS current sensor, and a leakage current sensor.

13. A method for performing an electrosurgical procedure at a surgical site on a patient, the method comprising:

continually sensing electrical and physical properties of the surgical site and generating a sensor signal as a function thereof;

processing the sensor signal using a processor, a control algorithm, and a map having at least one value to verify a reactance of tissue at the surgical site; and

entering an energy control mode, during which the electrosurgical generator matches an output of the control signal with a value from the map, based on the determination of the reactance of tissue in the processing step and the control module determines whether a tissue reactance is stable by monitoring whether tissue impedance dwells below a predetermined threshold for a predetermined period of time;

wherein the control module (i) distinguishes between reliable and unreliable parameter data and (ii) is prevented from inputting unreliable initial parameter data to the control algorithm, the unreliable initial parameter data defined as parameters having values above predetermined maximum values or below predetermined minimum values.

14. The method according claim 13, wherein the sensed electrical and physical properties of the surgical site of the continually sensing step are disregarded if no tissue reactance is verified at the surgical site.

15. The method according claim 13, wherein the processing step further includes comparing the sensor signal to a predetermined level and determining a reliability of the sensor signal.

16. A system comprising:

a sensor configured to continually sense at least one of an electrical and physical property of the surgical site and to generate a sensor signal as a function thereof; and

a control module configured to process the sensor signal using a processor, a control algorithm, and a map having at least one value, the control module further configured to verify a tissue reactance and to provide a control signal to an electrosurgical generator based on the verification of tissue reactance such that the electrosurgical generator enters energy control mode, the electrosurgical generator matches an output of the control signal with a value from the map, during which the control module is configured to recalculate the map when tissue impedance increases above a predetermined threshold and to signal the electrosurgical generator to reenter energy control mode and the control module determines whether the tissue reactance is stable by monitoring whether tissue impedance dwells below a predetermined threshold for a predetermined period of time;

wherein the control module (i) distinguishes between reliable and unreliable parameter data and (ii) is prevented from inputting unreliable initial parameter data to the control algorithm, the unreliable initial parameter data defined as parameters having values above predetermined maximum values or below predetermined minimum values.

17. A system according to claim 16, wherein during the energy control mode the electrosurgical generator is configured to adjust a parameter selected from the group consisting of a voltage adjustment, a current adjustment, a pulse width adjustment, a pulse frequency adjustment, an amplitude adjustment, a crest factor adjustment, a duty cycle adjustment, a repetition rate adjustment, a waveform shape adjustment, and a wave adjustment.

18. A system according to claim 16, further comprising a user interface which is configured to allow a user to select a surgical parameter selected form the group consisting of a type of instrument being connected to the generator, a tissue type, and a desired surgical effect.

19. A system according to claim 16, wherein the control module determines an impedance from the sensor signal, and wherein the control module is configured to compare the impedance to a predetermined level to verify a tissue reactance, wherein once reactance is verified the control signal is configured to reference a stored value corresponding to the impedance from the map, and wherein the control module is configured to control the generator based in part on the value.

20. A system according to claim 19, wherein if the impedance drops below a predetermined threshold over a predetermined period of time, the control module disregards the measured impedance, and the control module thereafter continues to sense whether tissue reactance occurs.