Electrosurgical generator and method for providing dual simultaneous power supplies

Abstract

An electrosurgical generator and method for providing simultaneous power supply to a patient via two accessories during an electrosurgical procedure or treatment is provided. The electrosurgical generator includes: a first generator including a first power source and a first radio frequency (RF) output stage; a second generator including a second power source and a second radio frequency (RF) output stage; and a controller that determines whether the carrier frequency and fixed modulation frequency of each of the first and second generators are compatible and, if the carrier frequency and fixed modulation frequency are compatible, enables simultaneous output from each of the first and second generators to a respective applicator.

Description

[Technical Field]

[0001] PRIORITY. This application claims priority to U.S. Provisional Patent Application No. 63 / 414,527, filed October 9, 2022, entitled "Electrosurgical Generator and Method for Providing Dual Simultaneous Power Supply and Method Thereof," the entire contents of which are incorporated herein by reference.

[0002] FIELD. The present disclosure relates generally to electrosurgery and electrosurgical systems and devices, and more particularly to an electrosurgical generator and method for providing simultaneous power supply to a patient via two accessories during an electrosurgical procedure or procedure.

[0003] Description of Related Art.

[0004] Radiofrequency electrical energy is widely used in surgery and is commonly referred to as electrosurgical energy, which is used to cut tissue and coagulate body fluids.

[0005] Electrosurgical instruments or accessories generally comprise either "monopolar" or "bipolar" devices. Monopolar devices comprise an active electrode on the electrosurgical instrument or accessory and a return electrode (also known as an indifferent electrode) that is attached to the patient. In monopolar electrosurgery, electrosurgical energy flows through the active electrode on the instrument, through the patient's body, and to the return electrode. Such monopolar devices are useful in surgical procedures where cutting and coagulation of tissue are required and stray currents do not pose a substantial risk to the patient.

[0006] A bipolar device includes an active electrode and a return electrode in a surgical instrument or accessory. In a bipolar electrosurgical device, electrosurgical energy flows through the active electrode into the patient's tissue and then through a short distance in the tissue to the return electrode. The electrosurgical effect is substantially localized to a small area of ​​tissue located between the two electrodes of the surgical instrument. Bipolar electrosurgical devices have proven useful in surgical procedures where stray currents may pose a risk to the patient or other procedural concerns require close proximity between the active and return electrodes. Surgeries involving bipolar electrosurgery often require methods and procedures that are substantially different from those involving monopolar electrosurgery.

[0007] Gas plasma is an ionized gas that can conduct electrical energy. Plasma is used in surgical devices to conduct electrosurgical energy to a patient using gases such as helium. The plasma conducts energy by providing a path of relatively low electrical resistance. Electrosurgical energy passes through the plasma to cut, coagulate, desiccate, or fulgurate the patient's blood or tissue. No physical contact is required between the electrode and the tissue being treated.

[0008] Electrosurgical systems that do not incorporate a regulated gas source can ionize the ambient air between the active electrode and the patient. The plasma thereby generated conducts electrosurgical energy to the patient, but the plasma arc typically appears more spatially dispersed compared to systems with a regulated ionizable gas flow.

[0009] The electrosurgical generator provides the necessary power to the electrosurgical instruments or accessories required for the selected instrument or mode of operation. Typically, electrosurgical generators have multiple modes of operation and multiple accessory outputs that can be operated on a "first-come-first-serve" (FCFS) basis, i.e., only one accessory can be operated at a time in sequence.

[0010] Therefore, there is a need for devices, systems, and methods for providing simultaneous power supply to a patient via two accessories during an electrosurgical procedure or procedure. Summary of the Invention

[0011] The present disclosure relates to an electrosurgical generator and method for providing simultaneous power supply to a patient via two accessories, such as instruments, handpieces, applicators, etc., during an electrosurgical procedure or treatment.

[0012] The electrosurgical generator of the present disclosure includes two generators configured to operate simultaneously in monopolar and / or bipolar modes, e.g., two monopolar modes or a monopolar mode plus a bipolar mode. Each generator or power supply channel has its own closed-loop power control using tissue voltage and current feedback sensors and a PWM (pulse-width modulation) controllable switching power supply (SMPS). The electrosurgical generator of the present disclosure can operate in simultaneous mode, i.e., when two accessories can be activated simultaneously to supply power to the patient, allowing two surgeons to work simultaneously rather than FCFS. The simultaneous mode can improve the usability of the electrosurgical generator of the present disclosure compared to conventional generators for certain applications and reduce surgical time.

[0013] According to one aspect of the present disclosure, an electrosurgical generator includes a first generator including a first power source and a first radio frequency (RF) output stage, a second generator including a second power source and a second radio frequency (RF) output stage, and a controller that determines whether a carrier frequency and a fixed modulation frequency of each of the first and second generators are compatible and, if the carrier frequency and the fixed modulation frequency are compatible, enables simultaneous output from each of the first and second generators to a respective applicator.

[0014] In one aspect, the controller synchronized the output from the first and second generators to start at the same time and in the same phase.

[0015] In another aspect, the electrosurgical generator further includes at least one first sensor that detects at least one first parameter of the output from the first RF output stage and at least one second sensor that detects at least one second parameter of the output from the second RF output stage.

[0016] In a further embodiment, the at least one first and second sensors are at least one of a voltage sensor and / or a current sensor.

[0017] In one aspect, the controller determines the power supplied by the first generator based on at least one first parameter and determines the power supplied by the second generator based on at least one second parameter, and if the power supplied by either the first or second generator exceeds a respective predetermined setpoint, the controller reduces the output power of either the first or second generator using the highest output power setting until the power supplied by the first and second generators falls below their respective predetermined setpoints.

[0018] In another embodiment, the electrosurgical generator includes at least one third sensor that detects at least one third parameter associated with the return electrode.

[0019] In yet another aspect, the controller determines a current through the return electrode based on at least one third parameter, and if the determined current exceeds a predetermined set point, the controller terminates the power supplied by the first and second generators.

[0020] In a further aspect, the controller generates an alert to cause a second return electrode to be used if the determined current exceeds a predetermined set point.

[0021] In yet another aspect, the controller determines a heating factor of the return electrode based on at least one third parameter, and if the determined heating factor exceeds a predetermined set point, the controller terminates the power supplied by the first and second generators.

[0022] In one aspect, the controller determines the heating factor using a moving integration filtering algorithm over a predetermined period of time.

[0023] In another aspect, the controller determines a first leakage current of the first generator based on at least one first parameter and at least one third parameter, determines a second leakage current of the second generator based on at least one second parameter and at least one third parameter, and if the total leakage current (total leakage current) of the first and second generators exceeds a predetermined set point, reduces the output of each of the first and second generators until the total leakage current of the first and second generators falls below the predetermined set point.

[0024] In a further aspect, the controller determines a first leakage current of the first generator based on the at least one first parameter and the at least one third parameter, determines a second leakage current of the second generator based on the at least one second parameter and the at least one third parameter, and if the total leakage current of the first and second generators exceeds a predetermined set point, reduces the output of the first generator or the second generator until the total leakage current of the first and second generators is below the predetermined set point.

[0025] In yet another aspect, the controller determines a first leakage current of the first generator based on the at least one first parameter and the at least one third parameter, determines a second leakage current of the second generator based on the at least one second parameter and the at least one third parameter, and if the leakage current of each of the first and second generators exceeds a predetermined set point, reduces the output of the respective generator until the respective leakage falls below the predetermined set point.

[0026] In one aspect, the electrosurgical generator further includes an input / output interface that allows for selection of an operating mode for each applicator coupled to the electrosurgical generator.

[0027] In another aspect, the controller determines whether the carrier frequency and the fixed modulation frequency of each of the first and second generators are compatible by retrieving the settings associated with each selected operating mode.

[0028] In a further aspect, the controller determines a total power (sum power) to be supplied based on the two selected operating modes, and if the total power exceeds a predetermined set point, the controller terminates the power supplied by the first and second generators.

[0029] In one aspect, the electrosurgical generator further includes at least two receptacles for receiving connectors of respective applicators, each receptacle coupled to one of the first and second generators.

[0030] In another aspect, the electrosurgical generator further includes an input / output interface that enables selection of an operating mode for each applicator coupled to the electrosurgical generator, the input / output interface providing an indication of a receptacle suitable for each of the respective applicators.

[0031] In yet another embodiment, each applicator includes a first monopolar applicator and a second monopolar applicator.

[0032] In yet another aspect, each applicator includes a monopolar applicator and a bipolar applicator. [Brief explanation of the drawings]

[0033] The above and other aspects, features, and advantages of the present disclosure will become more apparent in light of the following detailed description taken in conjunction with the accompanying drawings. [Figure 1] 1 is a diagram of an electrosurgical system according to an embodiment of the present disclosure; [Figure 2] FIG. 1 is a front view of an electrosurgical generator of an electrosurgical system according to an embodiment of the present disclosure; [Figure 3] FIG. 1 is a block diagram of an electrosurgical generator according to an embodiment of the present disclosure; [Figure 4] 1 is a schematic diagram of an electrosurgical generator according to an embodiment of the present disclosure; [Figure 5] 10 is a flowchart illustrating a method for operating an electrosurgical generator according to an embodiment of the present disclosure. [Figure 6] 10 is a flowchart illustrating a method for controlling power deviation of an electrosurgical generator according to an embodiment of the present disclosure. [Figure 7] 1 is a graph illustrating an ideal power curve according to an embodiment of the present disclosure. [Figure 8] 10 is a flowchart illustrating a method for determining whether one or more return electrodes are required for a particular procedure, according to an embodiment of the present disclosure. [Figure 9] 1 is a flowchart illustrating a method for controlling the heating coefficient of one or more return electrodes according to an embodiment of the present disclosure. [Figure 10] 1 is a flowchart illustrating a method for controlling leakage current according to an embodiment of the present disclosure. [Figure 11] 1 is a table illustrating the output characteristics of various modes of an electrosurgical generator in accordance with an embodiment of the present disclosure. It should be understood that the drawings are for purposes of illustrating the concepts of the present disclosure and are not necessarily the only possible configuration for illustrating the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0034] Preferred embodiments of the present disclosure are described below with reference to the accompanying drawings. In the following description, well-known functions or structures are not described in detail to avoid obscuring the present disclosure in unnecessary detail. In the following drawings and description, as is conventional, the term "proximal" refers to the end of a device (e.g., an instrument, accessory, apparatus, applicator, handpiece, forceps, etc.) that is closer to the user, while the term "distal" refers to the end that is farther from the user. As used herein, the phrase "coupled" is defined to mean directly connected or indirectly connected via one or more intermediate components. Such intermediate components may include both hardware-based and software-based components.

[0035] Those skilled in the art will recognize that the block diagrams presented herein represent conceptual views of illustrative circuitry embodying the principles of the present disclosure. Similarly, it will be recognized that any flowcharts, flow diagrams, state transition diagrams, pseudocode, and the like are substantially represented on a computer-readable medium and, therefore, represent various processes that may be performed by such a computer or processor, whether or not a computer or processor is explicitly depicted.

[0036] The present disclosure relates to an electrosurgical generator and method for providing simultaneous power supply to a patient via two accessories during an electrosurgical procedure or treatment.

[0037] 1, an electrosurgical system 1 according to the present disclosure is shown. System 1 includes an accessory or handpiece 10, also known as an applicator, and an electrosurgical generator unit (ESU) 50. In some embodiments, system 1 further includes a gas source 70.

[0038] The applicator 10 is configured to receive electrosurgical energy from the ESU 50 via the cable 20. The applicator 10 is further configured to receive inert gas from a gas source 70. In some embodiments, the inert gas is received from the gas source 70 and provided to the applicator 10 from the ESU 50 via the cable 20. It should be appreciated that the gas source 70 may be internal to the ESU 50 or external to the ESU 50. In other embodiments, the applicator 10 receives the inert gas directly from the gas source 70. The applicator 10 includes a handle housing 12 having a button 18 and a shaft 14 having a distal tip 16. When the button 18 is pressed, electrosurgical energy is supplied to the applicator 10 by the ESU 50, and inert gas is supplied to the applicator 10 by the gas source 70. The electrosurgical energy is used to energize an electrode disposed within the shaft 14. In one embodiment, when an inert gas passes through the energized electrode, a plasma is generated and emitted from the tip 16 into the patient tissue, which allows for the conduction of radio frequency (RF) energy from the electrode to the patient in the form of a precise plasma beam. In one embodiment, helium is used as the inert gas because it can be converted to plasma with very little energy, although other inert gases, such as argon, are also considered within the scope of this disclosure. Additionally, mixtures of inert gases may be utilized to generate the plasma. An exemplary applicator is shown and described in commonly owned U.S. Patent No. 9,060,765, the contents of which are incorporated by reference.

[0039] It should be appreciated that in some embodiments, the applicator 10 may be configured to apply or deliver energy to patient tissue in ways or forms other than plasma. For example, the applicator 10 may deliver RF energy to patient tissue by direct contact of electrodes to the patient tissue, with or without gas being delivered. In some embodiments, the electrodes may be retractable within the shaft 14 to allow the electrodes to be extended and used to directly contact the patient tissue to deliver RF energy, or retracted to deliver RF energy via plasma. In other embodiments, the electrodes may be configured as probes or heating elements (e.g., heated by applying current received from the ESU 50 to the heating element), and thermal energy may be applied directly to the patient tissue by the heating element. In further embodiments, the applicator 10 may be configured as a monopolar or bipolar device.

[0040] Referring to FIG. 2 , a front view of an ESU 50 according to an embodiment of the present disclosure is shown. In one embodiment, the ESU 50 includes a high-frequency electrosurgical generator section 61 and a gas flow controller 62 housed within a single housing 63. As described in more detail below, the electrosurgical generator section 61 includes two power supply channels that can simultaneously provide power through various receptacles or ports disposed on the housing 63. The ESU 50 includes a front panel face 19 that includes input / output sections 21, e.g., a touchscreen, for inputting commands / data to the ESU 50 and displaying data. The front panel 19 may further include various level controls 22 with corresponding indicators 24, e.g., dials, LCD screens, graphic displays, etc., and an on / off switch 28. In one embodiment, the input / output sections 21, controls 22, and indicators 24 may be embodied as a single touchscreen that can display data, e.g., power supplied, warnings, graphics, etc., and accept various inputs, e.g., mode selection, power settings, alarm limits, etc.

[0041] Additionally, ESU 50 includes a receptacle portion 26 that may include a return (or neutral) electrode receptacle 30, a monopolar foot switching receptacle 32, a first monopolar hand switching receptacle 34, a second monopolar hand switching receptacle 35, a bipolar hand switching receptacle 36, and a plasma receptacle 37. Gas flow controller 62 includes a gas receptacle portion 38 that may further include a gas A input receptacle 40 and a gas B input receptacle 42. Gas flow controller 62 may further include a user interface portion 44 that includes a selector switch or input 46 and a display 48. Selector switch or input 46 allows for selection of the type of input gas, the mixture of input gases, the composition and / or proportions of the mixture of input gases, the flow rate of gases applied to the handpiece or applicator, etc. 2 shows the high frequency electrosurgical generator section 61 and gas flow controller 62 contained within a single housing 63, it should be appreciated that the gas flow controller 62 may be provided as a separate external device that interfaces with the ESU 50 via a wired and / or wireless interface. When the high frequency electrosurgical generator section 61 and gas flow controller 62 are disposed in a single housing, a single touchscreen (or input / output interface) may be located on the front surface 19 of the housing 63 for input / output functions as described above for both the high frequency electrosurgical generator section 61 and the gas flow controller 62.

[0042] Referring to FIG. 3 , a block diagram of an ESU 50 according to an embodiment of the present disclosure is shown. The ESU 50 includes a controller or processor 51, a first generator GEN1 (including a power supply 52-1 and a radio frequency (RF) output stage 54-1), a second generator GEN2 (including a power supply 52-2 and a radio frequency (RF) output stage 54-2), an I / O interface 56, an alarm 58, a memory 60, a flow controller 62, sensors 64-1, 64-2, 64-3, and a communications module 66. The controller 51 is configured to control each generator GEN1, GEN2 by controlling the respective power supplies 52 to supply electrosurgical energy output from the respective RF output stages 54 to the applicator 10 via at least one conductor extending through the cable 20. It should be appreciated that the cable 20 may be coupled to the ESU 50 via any one of the receptacles (e.g., receptacles 34, 35, 36, 37) shown in FIG. 2 . 3, it should be further appreciated that the ESU 50 of the present disclosure may simultaneously accommodate two accessories, each having its own cable coupled to a respective separate receptacle or port. For example, a first monopolar applicator, accessory, or handpiece may be coupled to the ESU 50 via a first cable coupled to receptacle 34, while a second monopolar applicator, accessory, or handpiece may be coupled to the ESU 50 via a second cable coupled to receptacle 35.

[0043] In one embodiment, generators GEN1 and GEN2 may power predetermined receptacles; for example, generator GEN1 may power receptacle 34, while generator GEN2 powers receptacle 35. In another embodiment, switching between receptacles powered by a particular generator may be predefined in a table in firmware depending on the mode and sequence of operation. In a further embodiment, depending on the selected mode, controller 51 may determine the appropriate receptacle for a particular applicator or handpiece and then provide an indication of the determination on display 21. For example, display 21 may display a graphic representing a first applicator or handpiece and the appropriate receptacle for the first applicator or handpiece, and then display 21 may display a graphic representing a second applicator or handpiece and the appropriate receptacle for the second applicator or handpiece. In another example, display 21 may display a graphic representing the first applicator or handpiece, while the appropriate receptacle is illuminated. Display 21 may continue to display the first applicator or handpiece until it is actually coupled to the appropriate receptacle. If the first applicator or handpiece is coupled to the wrong receptacle, a warning may be displayed on display 21 and an audible warning may also be generated. Once the first applicator or handpiece is coupled to a recognized receptacle, display 21 may display the second applicator or handpiece, while the appropriate receptacle for the second applicator or handpiece is illuminated.

[0044] I / O interface 56 is configured to accept user input provided to controller 51 (e.g., via one or more buttons 22, 46 disposed on the housing of ESU 50, touchscreen 21, etc.) and output information received from controller 51 (e.g., data to indicators 24, a graphical user interface to touchscreen 21, graphic images to touchscreen 21, etc.). Audible alarms 58 are controllable via controller 51 to alert an operator of various conditions or events. It should be appreciated that when an audible alarm is triggered, a visual alert may also be generated and displayed on front surface 19 of housing 63, for example, via touchscreen 21.

[0045] Flow controller 62 is configured to control the flow rate of gas supplied from gas source 70 to applicator 10. Flow controller 62 is coupled to controller 51 and receives control signals from controller 51 based on user input via I / O interface 56, selector switch, or input 46, or based on algorithms or software functions stored in memory 60. Additionally, flow controller 62 may include appropriate sensors to determine the type of gas being input to receptacles 40, 42. Furthermore, flow controller 62 may use the input gas to generate a mixture of gases provided to the applicator. In the embodiment shown in FIG. 3, flow controller 62 is located within ESU 50; however, flow controller 62 can be external to ESU 50, such as in a separate housing, within applicator 10, etc.

[0046] The communications module 66 of the ESU 50 is configured to communicate with other devices (e.g., client devices, servers, etc.) via a communications link (e.g., wired or wireless) to send and receive data and communications. In the embodiment shown in FIG. 3 , the operator is alerted to various conditions by an audible alarm 58 and / or a visual alert displayed on the display 21, but in other embodiments, the controller 51 may use the communications module 66 to send notifications to at least one other device via a communications link (e.g., wired or wireless), the communications being associated with various conditions or events. The communications module 66 may be a modem, a network interface card (NIC), a wireless transceiver, etc. The communications module 66 performs its functions via hardwired and / or wireless connections. Hardwired connections may include, but are not limited to, hardwired cables, such as parallel or serial cables, RS232, RS485, USB cables, Firewire (1394 connection) cables, Ethernet, and suitable communications port configurations located on the surface of the housing 63. The wireless connection may operate under any of a variety of wireless protocols, including, but not limited to, a Bluetooth™ interconnection, an infrared connection, a radio transmission connection including computer digital signal broadcasting and reception commonly referred to as Wi-Fi or 802.11.X (where x represents the type of transmission), satellite transmission or any other type of communication protocol, an existing or developed communication architecture or system for wirelessly transmitting data including 900 MHz spread spectrum or other frequencies, Zigbee, and / or any mesh-enabled wireless communication.

[0047] In one embodiment, sensors 64-1, 64-2 of ESU 50 are coupled to the outputs of RF output stages 54-1, 54-2, respectively. Sensors 64-1, 64-2 are configured to sample the voltage and / or current (or any other electrical characteristic) of the outputs of RF output stages 54-1, 54-2 and provide the sampled voltage and / or current to controller 51. Controller 51 may use this information to determine one or more characteristics associated with the energy provided by ESU 50 to applicator 10, such as power, impedance, etc. In one embodiment, sensors 64-1, 64-2 may include at least one voltage sensor for detecting the output voltage and at least one current sensor for detecting the output current. Optionally, sensors 64-1, 64-2 may include at least one analog-to-digital converter for converting the detected signal to a digital signal input to controller 51; alternatively, at least one analog-to-digital converter may be provided in controller 51.

[0048] Additionally, sensor 64-3 is coupled to a return (or neutral) electrode 72. Sensor 64-3 is configured to sample the current (or any other electrical characteristic) returning from return electrode 72 and provide the sampled current to controller 51. Controller 51 may use this information to determine one or more characteristics related to the energy provided by ESU 50 to applicator 10, such as leakage current, the heating coefficient of the return electrode, etc. Optionally, sensor 64-3 may include at least one analog-to-digital converter for converting the sensed signal to a digital signal input to controller 51, or alternatively, at least one analog-to-digital converter may be provided in controller 51.

[0049] It should be appreciated that the functionality of ESU 50 illustrated in FIGS. 1-3 may be provided through the use of dedicated hardware and hardware capable of executing software in association with appropriate software. In one embodiment, some or all of the functionality of controller 51 may be performed by at least one processor, such as a computer or electronic data processor, digital signal processor or embedded microcontroller, field programmable gate array (FPGA), etc., in accordance with code, such as computer program code, software, firmware, register transfer logic and / or integrated circuits, coded to perform such functions, unless otherwise indicated. When provided by a processor, the functionality may be provided by a single dedicated processor, a single shared processor, or multiple individual processors, some of which may be shared. Furthermore, the explicit use of the terms “processor” or “controller” should not be construed to refer exclusively to hardware capable of executing software, but may implicitly include, but is not limited to, digital signal processor (DSP) hardware, read-only memory (ROM), random access memory (RAM), and non-volatile storage for storing software and / or firmware.

[0050] Referring to FIG. 4, a schematic diagram of an electrosurgical generator unit 50 according to the present disclosure is shown. Electrosurgical generator unit 50 includes a first generator section or power channel 102 and a second generator section or power channel 104. First generator section 102 includes generator GEN1, including power supply 52-1 and RF output stage 54-1, voltage sensors V1, V1B, and current sensors I1A, I1AB. First generator GEN1 is coupled to active electrode ACT1, such as a monopolar accessory or applicator, bipolar accessory, etc., via an appropriate receptacle, such as receptacles 34, 35, 36, and 37. Power supplied to active electrode ACT1 can be determined by the voltage and current detected by voltage sensors V1, V1B and current sensors I1A, I1AB. First generator section 102 further includes current sensors I1R1, I1R2 for sensing current returned from return (or neutral) electrode RE1.

[0051] The second generator section 104 includes a generator GEN2, which includes a power supply 52-2 and an RF output stage 54-2, voltage sensors V2 and V2B, and current sensors I2A and I2AB. The second generator GEN2 is coupled to an active electrode ACT2, such as a monopolar accessory or applicator, a bipolar accessory, or the like, via an appropriate receptacle, such as receptacles 34, 35, 36, and 37. The power supplied to the active electrode ACT2 can be determined by the voltage and current detected by the voltage sensors V2 and V2B and the current sensors I2A and I2AB. The second generator section 104 further includes current sensors I2R1 and I2R2 for detecting the current returned from the return electrode RE2.

[0052] It should be appreciated that capacitors C1 and C7, as well as capacitors C2 and C8, are provided to reduce the effects of neural stimulation on the patient. Capacitors C3, C4, C5, and C6 are used to accommodate a split return or neutral electrode (RE1) for GEN1. Capacitors C9, C11, C12, and C10 are used to accommodate a split return or neutral electrode (RE2) for GEN2. Each split return or neutral electrode may have a contact quality monitoring circuit operating in the 50 kHz to 60 kHz range, and thus the above capacitor arrangements are provided for such contact quality monitoring circuitry.

[0053] Additionally, Figure 4 represents the tissue impedance of GEN1 as RL1 and the tissue impedance of GEN2 as RL2. Typically, RL1 and RL2 can be in the range of 50-3000 ohms depending on different tissue regions.

[0054] 5, a flowchart illustrating operation of an electrosurgical generator unit 50 according to the present disclosure is provided. In step 202, a first accessory is coupled to one of the receptacles 34, 35, 36, 37 of the ESU 50, and the controller 51 receives input for a first mode, e.g., mode 1, of the first generator GEN1. The input may be received via the touchscreen 21 and / or buttons 22. In step 204, a second accessory is coupled to one of the remaining free or unused receptacles 34, 35, 36, 37 of the ESU 50, and the controller 51 receives input for a second mode, e.g., mode 2, of the second generator GEN2. Exemplary output modes of the ESU 50 may include at least the modes set forth in Table 1 below. [Table 1] FIG. 11 shows the output characteristics of the corresponding modes listed above.

[0055] In step 206, the controller 51 determines whether the mode 1 selected for GEN1 is compatible with the mode 2 of GEN2, e.g., whether mode 1 and mode 2 have the same carrier frequency (e.g., the output frequency shown in FIG. 11) and fixed modulation frequency (e.g., the repetition rate shown in FIG. 11). If a monopolar mode is selected for mode 1 and mode 2, both activated monopolar modes must have the same carrier frequency and fixed modulation frequency. For example, the following combinations of selected modes are compatible: monopolar cutting 1 mode + monopolar cutting 2, monopolar cutting 1 + monopolar pinpoint, monopolar cutting 2 + monopolar pinpoint, etc., and as can be seen in FIG. 11, these combinations include the same carrier frequency (e.g., output frequency 488 kHz) and fixed modulation frequency (e.g., both modes have the same repetition rate or one mode has no repetition rate). If this criterion is not met, a frequency beat with an interference pattern will occur based on the difference between the carrier frequency and / or modulation frequency. For example, when two output signals are mixed in the patient's body due to simultaneous motion, if the carrier frequencies f1, f2 of each output signal are different from each other, the following equation holds:

number

[0056] In addition to verifying that the carrier frequency and fixed modulation frequency are the same or compatible for both modes, the controller 51 may determine whether the maximum power of the two selected operating modes combined is greater than a predetermined adjustable set point. In one embodiment, the maximum power that can be supplied by both generators GEN1, GEN2 in simultaneous mode is 400 W. The controller 51 prevents operation if the sum of the power settings of both monopolar modes exceeds 400 W.

[0057] In step 210, both GEN1 and GEN2 should be synchronized, i.e., the generator (PG) driver waveforms start at the same time with the same phase. If this is not met, crosstalk interference between both monopolar modes may exist due to the effective potential difference between both monopolar active electrodes, e.g., between ACT1 and ACT2 shown in FIG. 4. In step 212, controller 51 monitors the output of GEN1 and GEN2 and controls the output of generators GEN1 and GEN2 with respect to power deviations, as described in detail below with reference to FIG. 6. In step 214, controller 51 monitors the current through return electrode 72 to determine whether two return electrodes are required for simultaneous use of two accessories, as described in detail below with reference to FIG. 8. In step 216, controller 51 monitors the heating coefficient of return electrode 72, as described in detail below with reference to FIG. 9. In step 218, controller 51 monitors the leakage current of each of generators GEN1 and GEN2, as described in detail below with reference to FIG. 10. Finally, the procedure for using two individually controlled accessories ends in step 220. It should be appreciated that steps 212, 214, 216, and 218 may be performed sequentially, simultaneously, and / or in any combination thereof.

[0058] The controller 51 monitors and controls the power deviation of each monopolar channel under all possible scenarios for power settings (0-300 W) and loads (0-4000 ohms) in both monopolar modes. The power deviation limit can be set to any practical value, i.e., an adjustable setpoint, so as not to exceed a 20% limit for any power setting and any load for each monopolar generator. The ESU 50 uses current sensors I1A (active), I1R1, and I1R2 (return) for generator GEN1 and I2A (active), I2R1, and I2R2 (return) for generator GEN2, as shown in Figure 4. If the limits are exceeded, the power is automatically reduced to within the selected limits. The controller 51 reduces the power of the monopolar generators by using higher power settings until the deviation falls below the limit.

[0059] 6, a method for controlling the power deviation of two generators GEN1 and GEN2 according to the present disclosure is provided. In step 302, the controller 51 obtains the power setting of GEN1 and monitors the power P1 supplied by GEN1 in step 304. In step 308, the controller 51 obtains the power setting of GEN2 and monitors the power P2 supplied by GEN2 in step 310. The supplied power may be determined by the following formula: P1 = V1 × (I1R1 + I1R2) at Z1 - GEN1 power < 1.2 × P1 curve (Z1) (P1=V1*(I1R1+I1R2)at Z1 - power of GEN1<1.2*P1curve(Z1)) P2 = V2 × (I2R1 + I2R2) at Z2 - Power of GEN2 < 1.2 × P2 curve (Z2) (P2=V2*(I2R1+I2R2)at Z2 - power of GEN2<1.2*P2curve(Z2)) where P1 is the power output of GEN1, P2 is the power output of GEN2, and the P1,2 curve (Z) is the power given by the ideal power curve for the corresponding generator and mode. Exemplary power curves are shown in Figure 7, where curve 352 is the ideal power curve for monopolar disconnect, curve 354 is the upper limit, and curve 356 is the lower limit. It should be recognized that in the graph shown in Figure 7, the x-axis is impedance in ohms and the y-axis is power in watts.

[0060] In step 306, the controller 51 determines whether the power deviation of GEN1 is greater than the set point. Each mode must not deviate from the mode power curve of the mode power setting by more than a predefined limit (percentage). In other words, the power deviation set point is a predetermined percentage above (or below) the mode power setting for a particular impedance according to the power curve of the operating mode. For example, if the power curve at 1200 ohms to set 30 W is 20 W (30 W only for a nominal load of 300 ohms), the actual power must not exceed 22 W (10%), i.e., the limit or set point. If the power deviation is below the limit or set point, the controller 51 continues to monitor the power supplied by GEN1 by returning to step 304. In step 312, the controller 51 determines whether the power deviation of GEN2 is greater than the limit or set point. If the power deviation is below the set point, the controller 51 continues to monitor the power supplied by GEN2 by returning to step 310. If the power deviation of either generator GEN1, GEN2 is greater than the set point, then in step 314, controller 51 determines which generator has the higher power setting. In step 316, controller 51 reduces the power output of the generator determined to have the higher power setting. In step 318, controller 51 determines the power deviation of both generator outputs to determine if the power deviation is still above the set point. If the determination in step 318 is positive, the method returns to step 316 and controller 51 further reduces the power output. Otherwise, if the power deviation is within limits in step 318, the method returns to steps 304 and 310 to monitor the power of each generator's output (step 320).

[0061] For example, if GEN1 is operating at 1200 ohms (and this is also detected) and the setting is 100 W, the nominal power is 100 W and the limit value is 120 W. GEN2 is set to operate at 200 W. Due to the mutual coupling between the active electrodes of GEN1 and GEN2 (i.e., ACT1, ACT2), the power P1 of GEN1 will be higher, but it must not exceed 120 W. To provide a safety margin, a limit of ±10% can be selected. The power P2 of GEN2 is reduced to reduce the deviation of the power P1 of GEN1. However, in other embodiments, it should be recognized that the power P1 of GEN1 may be further reduced, or instead of reducing the power P2 of GEN2, the power P1 of GEN1 may be reduced. The reduction is proposed to inform the user about the reduction and reduce the power level to a specific value P2new < P2set.

[0062] The simultaneous monopolar - monopolar mode can operate with one common return electrode. However, if the application requires a higher RF current, two return electrodes may be required to distribute the current and prevent the rise in electrode temperature. Although Figure 2 shows a single return electrode receptacle 30, it should be recognized that the receptacle 30 may correspond to more than one return electrode or neutral electrode. Thus, the ESU 50 of the present disclosure provides the ability to operate with one or two return electrodes or neutral electrodes.

[0063] The ESU 50 of the present disclosure monitors the current through the return electrode (RE) (or neutral electrode (NE)), and if it exceeds a predefined limit for one electrode, the ESU 50 suggests to the operator, via the I / O interface, to use two return or neutral electrodes. Most monopolar procedures require only one return or neutral electrode. This is also helpful from a setup and cost perspective. Only high-current monopolar applications may require two return or neutral electrodes. Such applications may use an active electrode with a larger surface area in contact with the tissue. Therefore, unless the user knows (based on the application) that two return or neutral electrodes will be required prior to the procedure, the user should always start with one return or neutral electrode. If the system detects a higher return or neutral electrode current during the procedure, the ESU 50 will stop and warn the user to connect a second return or neutral electrode or reduce the power in either monopolar mode.

[0064] Referring to FIG. 8, a method 400 for determining whether more than one return electrode is required for a particular procedure is provided. In step 402, a single return or neutral electrode 72 is coupled to the ESU 50 via the receptacle 30. In step 404, relays K1 and K2 (as shown in FIG. 4) are turned on when operating with one return or neutral electrode, i.e., the switches in relays K1 and K2 are closed. Capacitors C14 and C13 provide connection between the electrodes when only one return or neutral electrode is used. The capacitor values ​​are selected to prevent interference between the return electrode (RE) monitoring circuitry, which must continue to properly detect the return or neutral electrode's contact impedance with the patient. In step 406, the controller 51 monitors the current returned from the return electrode 72. In step 408, the controller 51 determines whether the monitored current is greater than an adjustable predetermined set point (i.e., I return_limit) using the following equation: (I1R1+I1R2)+(I2R1+I2R2) where I1R1, I1R2, I2R1, I2R2 are the currents detected by the corresponding sensors as shown in FIG.

[0065] If the monitored current is less than the limit or set point in step 408, the controller 51 continues to monitor the current in step 406. If the monitored current is greater than the limit in step 408, the controller 51 stops supplying power through the two generators GEN1 and GEN2 in step 410. In step 412, a warning is provided to the user / operator via the touchscreen 21, indicator 24, and / or alarm 58, for example, that the current exceeds the limit and a second return electrode or neutral electrode is required to continue. In step 414, relays K1 and K2 are opened, i.e., the switches in relays K1 and K2 are opened. In step 416, the user / operator is prompted to connect the second return electrode. In one embodiment, the controller 51 can determine when the second return electrode is connected and, when the second return electrode is connected, provide an indication to the user / operator that the procedure may continue.

[0066] The disclosed ESU 50 provides a measure of protection by calculating the heating factor of the return or neutral electrode during a procedure, such as when using an accessory in monopolar mode or when using an accessory in plasma mode. The heating factor is a way of describing the thermal stress on the NE (neutral electrode) based on the energy delivered over a finite period of time. The higher the effective RMS (root mean square) current flowing through the return or neutral electrode, the higher the heating factor. The heating factor is calculated according to the definition set forth in IEC 60601-2-2:2017. Heating factor = I 2 ×t where I is the monopolar current in amperes and t is the duration of the current in seconds. ​

[0067] The ESU 50 of the present disclosure uses a moving integral filtering algorithm to calculate the heating factor. Over a 60 second period, the heating factor is 30A. 2 s, where A is amperes. The moving integration algorithm 2 If the controller 51 detects a heating factor greater than s, it will trigger a fault and not leave the generators running, i.e., shut down GEN1, GEN2. 2 Once it drops below s, the generator can be turned on again.

[0068] The moving accumulation filtering algorithm implemented in the ESU 50 is illustrated by the flowchart 500 of FIG. 9. In step 502, the input NEM (neutral electrode monitor) current is provided by current sensors in the generator's NE path, e.g., current sensors I1R1 and I1R2 for return electrode 1 (RE1) and current sensors I2R1 and I2R2 for return electrode 2 (RE2). The analog signal of the sensor is fed to an A / D (analog-to-digital) converter and then converted to a 12-bit register in the controller 51, e.g., an FPGA. In step 504, this register value is sampled at 68.26 Hz and then placed in a FIFO (first-in, first-out) buffer with 4096 elements in step 506. In one embodiment, the FIFO buffer is integrated into the FPGA. The number of elements and sampling frequency provide accumulated data for 60 seconds (s). In step 510, the controller 51 determines whether the FIFO is full. If the determination is negative, further values ​​are read. In step 512, the FIFO is either already full or has already accumulated current for the past 60 seconds. When a new current value is entered, the first current value entered into the FIFO should be deleted, and so on. Thus, the accumulated / accumulated current for the past 60 seconds (s) is always provided. A total of 4096 samples at a sampling rate of 68.26 Hz yields exactly 60 s ((1 / (68.26)) x 4096 = 60).

[0069] Next, in step 514, the FIFO with the current sample values ​​is used to accumulate the squared values ​​of the current for the past 60 seconds in a 64-bit register. In step 518, the accumulation register is divided by 68266 as follows:

number

[0070] If the result from step 518 is greater than 600,000, the method proceeds to step 522. Next, in steps 522 and 524, the result from step 518 is scaled into a 24-bit register containing the rolling accumulated heating factor over 60 seconds multiplied by 1000. The accumulation / store register is 2 saturates at s because the accumulated current is too high for the surgical procedure. In either case, the algorithm will adjust the heating factor to 30 A as shown in steps 526 and 528 below. 2 If the value exceeds 600A, the fault flag is triggered and the operation is stopped. 2 When measuring more than s, the output is 600A 2 It remains s.

[0071] In step 526, 30000 or 30A 2 The decision logic is set to trigger a fault condition for values ​​of s (determined in steps 522 and 524) above a heating factor of 30000 or 30 A. 2 If the heating factor is greater than 30000 or 30A, a fault is triggered in step 128 and the generator (i.e., ESU 50 including GEN1, GEN2) and associated handpiece are deactivated. 2 If so, then in step 530 operation of the generator and associated handpiece continues.

[0072] The ESU 50 of the present disclosure provides an additional measure of protection by monitoring leakage current. The ESU 50 monitors the difference between the RF (radio frequency) currents of the active electrode (e.g., ACT1, ACT2) and the return electrode (e.g., RE1, RE2) of each generator (when operating with two return electrodes (RE)) or both generators (when operating with one return electrode (RE)). Typically, a difference in current between the active and return electrodes is due to excessive leakage current.

[0073] Referring to FIG. 10, a method 600 for monitoring and controlling leakage current is provided. In step 602, controller 51 monitors the current through at least one active electrode (e.g., ACT1, ACT2) of generators GEN1, GEN2 via sensors 64-1, 64-2 as shown in FIG. 3 or current sensors I1A, I2A as shown in FIG. 4. In step 604, controller 51 monitors the current through at least one return electrode via sensor 64-3 as shown in FIG. 3 or current sensors I1R1, I1R2, I2R1, I2R2 as shown in FIG. 4. In step 608, controller 51 determines the leakage current as follows: Ileakage1=I1A-(I1R1+I1R2) Ileakage2=I2A-(I2R1+I2R2) Ileakage1+Ileakage2 <Ileak_limit where Ileakage1 is the leakage current of GEN1, Ileakage2 is the leakage current of GEN2, and Ileakage1+Ileakgae2 is the total generator leakage.

[0074] In one embodiment, the limit (i.e., Ileak_limit) for monopolar mode or all active monopolar modes in the case of simultaneous operation is Ileakage<150 mA, i.e., the total generator leakage must be less than 150 mA. If a predetermined adjustable limit for leakage current is exceeded in step 608, the controller 51 reduces the power of the monopolar generators (e.g., GEN1 and GEN2) until the difference between the active and return electrodes falls below the limit (step 610). Furthermore, when the leakage limit (i.e., Ileak_limit) is exceeded, a warning may be provided to the user / operator indicating that the leakage current has exceeded the predetermined limit and that power will be reduced. In one embodiment, the power is adjusted individually for each generator (e.g., GEN1, GEN2) until the corresponding leakage current is within the limit.

[0075] It should be recognized that the various features shown and described are interchangeable, that is, features shown in one embodiment may be incorporated into another embodiment.

[0076] While the present disclosure has been shown and described with reference to certain preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and details can be made therein without departing from the spirit and scope of the present disclosure as defined by the appended claims.

[0077] Furthermore, while the foregoing text sets forth detailed descriptions of numerous embodiments, it should be understood that the legal scope of the present invention is defined by the language of the claims set forth at the end of this patent. The detailed description is to be construed as exemplary only and does not describe every possible embodiment, as describing every possible embodiment would be impractical, if not impossible. Numerous alternative embodiments can be implemented, using either current technology or technology developed after the filing date of this patent, and still fall within the scope of the claims.

[0078] It is also understood that unless a term is expressly defined in this patent using the sentence, "As used herein, the term '______' is hereby defined to mean _____," or a similar sentence, no intention, express or implied, to limit the meaning of the term beyond its plain or ordinary meaning is intended, and such term should not be construed as limited in scope based on any statement made in any section of this patent (other than the language of the claims). To the extent that terms recited in the claims at the end of this patent are referred to in this patent in a manner consistent with a single meaning, this is done solely for clarity to avoid confusing the reader, and it is not intended that such claim terms be limited, implicitly or otherwise, to that single meaning. Finally, unless a claim element is defined by the word "means" and reciting a function without reciting any structure, the scope of the claim element is not intended to be construed under application of the sixth paragraph of 35 U.S.C. 112.

Claims

1. 1. An electrosurgical generator comprising: a first generator including a first power source and a first radio frequency (RF) output stage; a second generator including a second power source and a second radio frequency (RF) output stage; a controller that determines whether a carrier frequency and a fixed modulation frequency of each of the first and second generators are compatible, and, if the carrier frequency and the fixed modulation frequency are compatible, enables simultaneous output from each of the first and second generators to a respective applicator. Electrosurgical generator.

2. the controller synchronizes the outputs from the first and second generators to start at the same time and in the same phase; 10. An electrosurgical generator according to claim 1.

3. at least one first sensor that detects at least one first parameter of the output from the first RF output stage; and at least one second sensor detecting at least one second parameter of the output from the second RF output stage.

10. An electrosurgical generator according to claim 1.

4. the at least one first sensor and the at least one second sensor are at least one of a voltage sensor and / or a current sensor; 4. An electrosurgical generator according to claim 3.

5. the controller determines the power being supplied by the first generator based on the at least one first parameter and determines the power being supplied by the second generator based on the at least one second parameter, and if the power supply of either the first or second generator exceeds a respective predetermined set point, the controller reduces the output power of either the first or second generator using a highest output power setting until the power supply of the first and second generators falls below the respective predetermined set point; 4. An electrosurgical generator according to claim 3.

6. further comprising at least one third sensor for detecting at least one third parameter associated with the return electrode; 10. An electrosurgical generator according to claim 1.

7. the controller determines a current through the return electrode based on the at least one third parameter, and if the determined current exceeds a predetermined set point, the controller terminates power supplied by the first and second generators.

7. An electrosurgical generator according to claim 6.

8. the controller generates an alert to activate a second return electrode if the determined current exceeds the predetermined set point.

8. An electrosurgical generator according to claim 7.

9. the controller determines a heating factor of the return electrode based on the at least one third parameter, and if the determined heating factor exceeds a predetermined set point, the controller terminates power supplied by the first and second generators.

7. An electrosurgical generator according to claim 6.

10. the controller determines the heating factor using a moving integral filtering algorithm over a predetermined period of time; 10. An electrosurgical generator according to claim 9.

11. the controller determines a first leakage current of the first generator based on the at least one first parameter and the at least one third parameter, determines a second leakage current of the second generator based on the at least one second parameter and the at least one third parameter, and if a total leakage current of the first and second generators exceeds a predetermined set point, reduces an output of the first and second generators until the total leakage current of the first and second generators falls below the predetermined set point; 7. An electrosurgical generator according to claim 6.

12. the controller determines a first leakage current of the first generator based on the at least one first parameter and the at least one third parameter, determines a second leakage current of the second generator based on the at least one second parameter and the at least one third parameter, and if a total leakage current of the first and second generators exceeds a predetermined set point, reduces an output of the first generator or the second generator until the total leakage current of the first and second generators falls below the predetermined set point; 7. An electrosurgical generator according to claim 6.

13. the controller determines a first leakage current of the first generator based on the at least one first parameter and the at least one third parameter, determines a second leakage current of the second generator based on the at least one second parameter and the at least one third parameter, and if the leakage current of each of the first and second generators exceeds a predetermined set point, reduces the output of the respective generator until the respective leakage current falls below the predetermined set point; 7. An electrosurgical generator according to claim 6.

14. and an input / output interface that allows selection of an operating mode for each applicator coupled to the electrosurgical generator.

10. An electrosurgical generator according to claim 1.

15. the controller determining whether the carrier frequency and fixed modulation frequency of each of the first and second generators are compatible by obtaining settings associated with each of the selected operating modes; 15. An electrosurgical generator according to claim 14.

16. the controller determines a total power to be supplied based on the two selected operating modes, and if the total power exceeds a predetermined set point, the controller terminates the power supplied by the first and second generators.

15. An electrosurgical generator according to claim 14.

17. and further comprising at least two receptacles for receiving connectors of respective applicators, each of said receptacles being coupled to one of said first and second generators.

10. An electrosurgical generator according to claim 1.

18. and an input / output interface for enabling selection of an operating mode for each applicator coupled to the electrosurgical generator, the input / output interface providing an indication of an appropriate receptacle for each of the respective applicators.

18. An electrosurgical generator according to claim 17.

19. the respective applicators include a first monopolar applicator and a second monopolar applicator; 10. An electrosurgical generator according to claim 1.

20. The respective applicators include monopolar applicators and bipolar applicators.

10. An electrosurgical generator according to claim 1.

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