Electrosurgical Generator Verification System

Abstract

To provide systems and methods for performing a self-verification system test upon activation of an electrosurgical generator.SOLUTION: This is achieved through implementation of an automated self-verification process at the power start-up of the generator, which makes it possible to rapidly identify a potential generator issue prior to any use of a connected electrosurgical instrument or supply of any RF energy to the tissue or vessel through the electrosurgical instrument. Additionally, one or more internal impedance loads are integrated within the electrosurgical generator. The internal impedance loads with multiple configurations are utilized to verify the voltage, current, power and / or phase measurements of the generator. By incorporating or integrating the self-verification process and its related hardware resources into the electrosurgical generator, many improvements in outcome of pre-surgical procedures may be achieved.SELECTED DRAWING: Figure 8

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the benefit of priority of co - pending applications U.S. Provisional Patent Application No. 62 / 727,176, filed September 5, 2018, and U.S. Provisional Patent Application No. 62 / 727,195, filed September 5, 2018, which are hereby incorporated by reference in their entirety for all purposes.

[0002] The disclosure of the present invention generally relates to electrosurgical generator systems and methods, and more particularly to output verification of an electrosurgical generator configured to supply radio - frequency (RF) energy.

Background Art

[0003] Electrosurgical devices or instruments that use radio - frequency (RF) energy to perform certain surgical tasks such as coagulating, lysing, or cutting tissue are available. Such electrosurgical instruments typically fall into two categories, namely, monopolar and bipolar. In monopolar instruments, electrical energy is supplied to one or more electrodes on the instrument at a high current density, while an individual return electrode is electrically coupled to the patient and is often designed to minimize the current density. Bipolar electrosurgical instruments that operate without a separate return electrode can deliver electrical signals to a focused tissue area with reduced risk.

Summary of the Invention

Problems to be Solved by the Invention

[0004] Even with the relatively concentrated surgical effect of bipolar electrosurgical instruments, surgical outcomes often depend heavily on the surgeon's skill. Enhanced generators have been developed to reduce this dependence. However, such generators have the drawback that they may give inconsistent results in determining tissue coagulation, dissolution, or cutting endpoints for various tissue types or connective tissue masses. These systems may also fail to provide consistent electrosurgical results between the use of different instruments with different instrument and electrode shapes facing different tissue types and tissue volumes. Some of these shortcomings may be exacerbated by inaccurate RF energy generation, measurement, calibration, and testing of such systems. Unavailable or unreliable testing equipment and / or unobtainable or inexperienced personnel also contribute to these shortcomings or do little to overcome them. Accordingly, embodiments of the present invention are intended to eliminate or at least mitigate the above problems of conventional electrosurgical generators. [Means for solving the problem]

[0005] Various embodiments provide an electrosurgical system for sealing, dissolving, and / or cutting tissue. The electrosurgical system includes an electrosurgical generator and an electrosurgical instrument or device. In various embodiments, the electrosurgical generator may include an RF amplifier, a feedback system, and a primary controller. The RF amplifier supplies RF energy through a detachably coupled electrosurgical instrument configured to dissolve, seal, and / or cut tissue. The primary controller is arranged to start and stop the supply of RF energy, and the feedback system is arranged to monitor the supplied RF energy. By monitoring or verifying the electrical properties of the RF output, the electrosurgical generator of the present invention ensures, in various embodiments, that the outputted RF energy is optimal for surgical treatment of tissue or blood vessels.

[0006] One aspect of the present invention provides an electrosurgical system for performing surgical procedures. The electrosurgical system may include an electrosurgical generator which is configured to perform a self-validating system test upon startup of a generator and a plurality of internal impedance loads. The electrosurgical generator includes a processor configured to trigger the initiation of a self-validating system test after it is determined that a predetermined period has elapsed since the generator was started. If no fault is detected in the generator, the processor allows RF energy to be supplied to a connected electrosurgical hand device. If a fault in the generator is detected by the self-validating system test over a period of time, the processor generates a system error and notifies the user or surgeon of the generator error.

[0007] A second aspect of the present invention provides a method for performing an automated verification and self-verification system for an electrosurgical generator before performing a surgical procedure. The method includes the steps of: starting a self-verification system test after determining that a predetermined period has elapsed when the generator is started; setting an RF adjustment mode and an RF resolution setting after starting the self-verification system test; generating RF energy and directing the RF output to a plurality of impedance loads within the generator; determining whether the self-verification system test is complete; and recording a self-verification system test completion timestamp when the self-verification system test is completed. After the completion of the self-verification system test, the method further includes the step of determining whether a generator malfunction has occurred and, accordingly, enabling the start or stop of the supply of RF energy to connected electrosurgical instruments.

[0008] A third aspect of the present invention provides a control system for use with an electrosurgical generator which is configured to perform a self-validation system test when the generator is started. The control system may include an RF amplifier for supplying RF energy, a feedback system for continuously monitoring the electrical properties of the supplied RF energy and generating a digital RF signal associated therewith, and a primary microcontroller configured to initiate a self-validation system test and, at least in part, supply RF energy to a connected electrosurgical hand device and to stop supplying RF energy.

[0009] A fourth aspect of the present invention provides an electrosurgical system for performing a surgical procedure. The electrosurgical system may include an electrosurgical generator configured to supply electrosurgical RF energy to tissue, and an electrosurgical instrument comprising at least one active electrode configured to apply the supplied electrosurgical RF energy to the tissue. The electrosurgical generator may include a microprocessor programmed to adjust the generator's RF output to predetermined RF adjustment values ​​across a plurality of RF adjustment modes and a plurality of RF resolution setpoints. The electrosurgical generator may further include a feedback system configured to measure the electrical properties of the RF output supplied to one or more internal impedance loads across a plurality of channels. The microprocessor may further be programmed to compare all measurements of the feedback system channels for each of the plurality of RF adjustment modes and RF resolution setpoints to determine whether fault conditions are present in the generator.

[0010] A fifth aspect of the present invention provides an electrosurgical generator. The electrosurgical generator may include a plurality of impedance loads integrated within an RF amplifier that supplies RF energy, and a feedback system that measures the electrical properties of the RF energy directed to the plurality of impedance loads across a plurality of channels. The electrosurgical generator further includes a primary microcontroller configured to verify the RF output of the generator across a plurality of RF adjustment modes and RF resolution setpoints in order to initiate a self-verification system test at generator startup to determine whether a generator fault exists.

[0011] Various embodiments provide an electrosurgical generator. The generator includes a plurality of switchable impedance loads integrated within the generator and through which RF energy is supplied, and a microcontroller configured to switch to one or more of the plurality of switchable impedance loads to verify the RF output of the generator.

[0012] Many of the incidental features of the present invention will be better understood by referring to the above and below descriptions and will be more readily apparent when considered in relation to the accompanying drawings.

[0013] The disclosure of the present invention will be described in reference to the attached figures. [Brief explanation of the drawing]

[0014] [Figure 1] This is a perspective view of an electrosurgical generator according to various embodiments of the present invention. [Figure 2] This is a perspective view of an electrosurgical hand device according to various embodiments of the present invention. [Figure 3] This is a perspective view of alternative embodiments of an electrosurgical hand device according to various embodiments of the present invention. [Figure 4] This is a block diagram of an electrosurgical generator according to various embodiments of the present invention. [Figure 5] This is a block diagram of an embodiment of a control system for an electrosurgical generator coupled to an electrosurgical hand device. [Figure 6] This diagram provides a more detailed block diagram of an embodiment of the feedback system within the control system of an electrosurgical generator. [Figure 7] This is a schematic diagram of an example of hardware resources implemented within the RF amplifier of an electrosurgical generator to perform self-verification system testing. [Figure 8] This is a flowchart illustrating various embodiments of the operation or processing of a self-verification system according to various embodiments of the present invention. [Figure 9] This is a flowchart illustrating various embodiments of the operation or processing of a self-verification system according to various embodiments of the present invention. [Figure 10] This is a flowchart illustrating an exemplary method for performing self-verification system testing of an electrosurgical generator. [Modes for carrying out the invention]

[0015] In the attached drawings, similar components and / or features may have the same reference label. When a reference label is used herein, its description is applicable to any similar component having the same reference label.

[0016] The following description provides only preferred exemplary embodiments and is not intended to limit the scope, applicability, or configuration of the disclosure of the present invention. Rather, the following description of preferred exemplary embodiments will provide an authoritative explanation for carrying out preferred exemplary embodiments of the disclosure of the present invention. It should be understood that various modifications can be made to the function and configuration of the elements without departing from the spirit and scope of the invention as enumerated in the appended claims.

[0017] The disclosure of this invention relates in general to electrosurgical systems. Specifically, it relates to a new generation of electrosurgical generators that can initiate and perform automated verification and self-verification system tests of the generator.

[0018] To maintain an electrosurgical generator, verification of the generator's output is often necessary to ensure that the RF being output from the generator is as intended. This verification can be performed periodically, for example, every 12 months or 2 years, and often by a user-interactive or manual system or process. The system or process may also require the connection of various external devices to the generator. These external devices can include a verification adapter, an external load, for example, a 10 - 500 ohm load with a reduced power rating and an increased voltage rating, and / or a measurement device, for example, an oscilloscope, a differential voltage probe, and a current probe.

[0019] The user must then connect the appropriate adapter, load, and / or measurement device and perform specified tests that require adjustments to the generator, external devices, and / or measurement devices and their connections. In addition to this, it is necessary to appropriately monitor and record the test results, along with understanding the errors and physically removing the malfunctioning generator from use. Also, to perform the output verification of the generator, the generator must be removed from the circuit and not be used in a surgical procedure, and often cannot be performed at the surgical site, such as a hospital, due to lack of experience, staff, or equipment.

[0020] Embodiments of the present invention relate to systems and methods for enhancing surgical outcomes by providing a generator having an accurate RF energy generation, measurement, calibration, and / or self-test system. The present invention according to various embodiments enables the detection of malfunctions at startup, thereby shortening troubleshooting and surgical operation times while avoiding other potential surgical difficulties. This is achieved through the implementation of an automated self-verification process at power-on of the electrosurgical generator that enables the rapid identification of potential generator problems prior to the use of any connected electrosurgical instrument or the supply of any RF energy through an electrosurgical instrument to tissue or a conduit.

[0021] Electrosurgical generators in various embodiments may include one or more internal impedance loads for performing self-verification processes. Multiple configurations of internal impedance loads are used to verify the generator's voltage, current, power, and / or phase measurements. By incorporating or integrating self-verification processes and their associated hardware resources into the electrosurgical generator, many improvements in preoperative procedure outcomes can be achieved. These improvements include, but are not limited to, eliminating the need to connect external devices to the generator, thereby eliminating the risk of using unavailable or unreliable test equipment and / or unavailable or inexperienced personnel. In addition, the need to remove the generator from the circuit to perform generator output verification is completely eliminated.

[0022] The following sections provide a detailed description of electrosurgical systems and methods according to various embodiments of the present invention, with each section individually describing the electrosurgical generator, electrosurgical instruments, and control systems and methods used to perform automated self-verification system testing of the generator.

[0023] Various embodiments provide an electrosurgical generator that controls the transmission of electrosurgical energy or radio frequency (RF) energy, modulates the RF energy, and, in various embodiments, measures and monitors the electrical properties, such as the phase, current, voltage, and / or power of the RF energy supplied to a connectable electrosurgical instrument, to ensure optimal sealing, dissolution, and / or cutting of tissue or blood vessels. In various embodiments, the generator may include a feedback system that modulates and controls an RF amplifier that generates the required RF energy to provide an optimal RF output for sealing, dissolution, and / or cutting tissue / blood vessels under dynamic conditions such as changing load, procedural conditions, or operating conditions, by determining such electrical properties via a microcontroller.

[0024] Referring first to Figures 1 and 2, exemplary embodiments of electrosurgical systems according to various embodiments of the present invention are shown. As shown in these figures, the electrosurgical system may include an electrosurgical generator 10 and a detachably connectable electrosurgical tool or instrument 20. The electrosurgical hand device or electrosurgical instrument 20 may be electrically coupled to the generator 10 through a cable connection to a device key or connector 21 extending from the instrument 20 to a device connector or access port 12 on the generator 10. The electrosurgical instrument 20 may include audible, tactile, and / or visual indicators to notify the user of specific or defined statuses of the instrument 20, such as the start and / or end of a dissolution procedure. In some embodiments, a manual controller, such as a hand or foot switch, may be connectable to the generator 10 and / or instrument 20 to enable defined selection control of the instrument, such as to start a dissolution procedure.

[0025] In various embodiments, the electrosurgical generator 10 includes a display 14 that can show the status of the electrosurgical system, including the status or operating status of one or more electrosurgical instruments and / or accessories, connectors or their connections, the generator, and error indicators, among other information. The electrosurgical generator 10 in various embodiments of the present invention may include a user interface, such as a plurality of buttons 16. The plurality of buttons 16 allow user interaction with the electrosurgical generator 10. This user interaction may include, for example, requesting an increase or decrease in the electrical energy supplied to one or more instruments 20 coupled to the electrosurgical generator 10. In various embodiments, the generator 10 further includes a user-accessible power-on switch or button 18 that, when activated, powers the generator 10 to activate or start the generator's self-verification system test. In other embodiments, the display 14 may be a touchscreen display, resulting in the integration of data display and user interface functionality.

[0026] In various embodiments, the electrosurgical generator 10 of the present invention is configured to output radio frequency (RF) energy through one or more electrodes to an electrosurgical instrument or hand device 20 that can be connected to seal, dissolve, and / or cut tissue or blood vessels. According to embodiments of the present invention, the electrosurgical generator 10 is configured to generate RF energy up to 300V, 8A, and 375VA, and is also configured to determine the phase angle or difference between the RF output voltage and the RF output current of the generator during the activation or supply of RF energy. In this way, the electrosurgical generator 10 monitors the RF energy output (e.g., voltage, current, power, and / or phase) by adjusting the voltage, current, and / or power. In one embodiment, the generator 10 can stop, terminate, or otherwise interrupt the RF energy output under predetermined conditions. As an example, these predetermined conditions may be any of the following: when the device switch is asserted and stopped (e.g., when the dissolution button is released), when the time value is satisfied, and / or when the active phase angle and / or active phase change is at or above the phase and / or phase change stop indicating the end of surgery, such as tissue dissolution or cutting.

[0027] The electrosurgical instrument 20 may include, according to embodiments of the present invention, an elongated shaft 26 having a proximal end coupled to an actuator 24 or from which the actuator 24 extends, and a distal end coupled to a jaw portion 22 or from which the jaw portion 22 extends. The longitudinal axis extends from the proximal end to the distal end of the elongated shaft 26. In one embodiment, the actuator 24 may include a movable handle 23 pivotably coupled to a fixed handle or housing 28. The movable handle 23 is coupled to the fixed handle or housing 28 through a central floating pivot or a primary floating pivot. When activated, the movable handle 23 is operated by a user, e.g., a surgeon, to operate the jaw portion 22 at the distal end of the elongated shaft 26, thereby selectively opening and closing the jaw portion 22. When tissue or blood vessels are grasped between the jaw portions 22, a switch or button 29 is activated by the surgeon to seal, dissolve, and / or cut the tissue / blood vessels between the jaw portions 22. With button 29 activated, the associated circuits or contacts are connected to the connectors associated with the generator 10 to supply RF energy to tissue that is grasped between the jaw portions 22 or otherwise in contact with one or more electrodes of the jaw portions.

[0028] In various embodiments, the electrosurgical instrument 20 further includes a mechanical or electric cutting blade that can be coupled to a blade actuator such as a blade lever or trigger 25 on a fixed handle or housing 28. The cutting blade is actuated by the blade trigger 25 to divide or cut tissue between jaw portions 22. In various embodiments, a blade slider is connected to the blade trigger 25, with projections extending from the proximal portion of the blade slider into an opening at one end of the blade trigger to connect the components together. The other end of the blade trigger is exposed and accessible by the user, and the blade trigger 25 is pivotable around a trigger pivot at or near the midpoint of the blade trigger. Thus, with the blade trigger 25 pulled or rotated proximal by the user, the end of the blade trigger connected to the blade slider slides or moves distally along the blade slider. Integrated with or attached to the distal end of the blade slider is the cutting blade, knife, or cutting edge or cutting surface. Therefore, as the blade slider moves longitudinally parallel through the blade channel of the jaws, the tissue held between the jaws 22 is cut. In one embodiment, the cutting edge or cutting surface is inclined to facilitate cutting of the tissue between the jaws 22. In various embodiments, the cutting blade is a curved blade, a hook, a knife, or other cutting element sized and configured to cut the tissue between the jaws 22.

[0029] In various embodiments, the elongated shaft 26 includes an actuation tube or rod that connects the jaw portion 22 to the actuator. In one embodiment, the actuator includes a rotary shaft assembly that includes a rotary knob 27 positioned on the outer cover tube of the elongated shaft 26. The rotary knob 27 allows the surgeon to rotate the shaft of the device while gripping the actuator. In various embodiments, the elongated shaft 26 is 360° rotatable, while in other embodiments, the rotation of the elongated shaft 26 is limited to 180°, i.e., 90° clockwise and 90° counterclockwise. Figure 3 shows an alternative embodiment of the electrosurgical hand device 20' that can be connected to the electrosurgical generator 10. The electrosurgical hand device 20' is similar but includes different features and has different surgical applications than the electrosurgical hand device 20.

[0030] Referring next to Figure 4, a block diagram of an electrosurgical generator 10 according to an embodiment of the present invention is shown. As shown in this figure, the electrosurgical generator 10 may include a power supply module, for example, a power-on module 31 coupled to two DC 48V power supplies 32, 33, for example, an AC main input. The power supply module converts the AC voltage from the AC main input to a DC voltage and supplies power to various circuits of the generator 10 through a housekeeping power supply 34, in particular to power an RF amplifier 40 that generates or outputs RF energy. In one embodiment, the RF amplifier 40 may include a combined Buck and H-bridge circuit that converts the DC voltage input to an RF output and, in another embodiment, a variable amplitude 350 kHz sine wave. The DC voltage input is a DC 96V input generated by two DC 48V power supplies 32, 33 coupled in series. One of the DC 48V power supplies 32, 33 is configured to generate a low voltage rail, in particular to supply a standby voltage for powering up the generator 10.

[0031] The RF output and the amplitude of the RF waveform output in various embodiments are controlled and regulated by an electrosurgical control system or digital integral servo control system 100 embedded in or integrated within the electrosurgical generator 10. Figure 5 shows in more detail a block diagram of an embodiment of the control system 100 of the electrosurgical generator 10 coupled to an electrosurgical hand device 20. As shown in Figures 4-5, the control system 100 may include an RF amplifier 40, a primary microcontroller 50, and a feedback system 60. The control system 100 varies between regulating the voltage, current, or power of the RF output generated by the RF amplifier 40. In various embodiments, the feedback system 60 measures the RF output, processes the measurement data, and then digitally feeds the real and imaginary components of the RF output to the primary microcontroller 50. The primary microcontroller 50 may include a primary field-programmable gate array (FPGA) and a processor according to embodiments of the present invention. For example, the processor of the microcontroller 50 may include an Advanced Reduced Instruction Set Machine (ARM) processor. The primary FPGA processes the data received from the feedback system 60 and adjusts the output of the RF amplifier 40 to satisfy a desired adjustment target. In various embodiments, the feedback system 60 consists of an analog input, digital processing, and a digital output.

[0032] Referring to Figure 6, a block diagram of an embodiment of the feedback system 60 within the control system 100 of the electrosurgical generator 10 is shown in more detail. As shown in this figure and in various embodiments of the present invention, the verification system 60 may include a main channel 601 and a redundant channel 602. In various embodiments, the main channel 601 and the redundant channel 602 may include separate but identical components. In addition, the main channel and the redundant channels 601 and 602 follow separate but identical circuits and, in one embodiment, are both connected to the RF amplifier 40 and the RF output.

[0033] The feedback system 60 further includes a verification channel 603 which is separate from but similar to the main channel 601 and redundant channel 602 in various embodiments. The verification channel 603 may include components that are separate from but similar to those of the other channels. In one embodiment, the verification channel 603 may include the same components as the main channel 601 and redundant channel 602, but the components in the verification channel 603 have higher ratings, e.g., higher resolution or lower drift, and are often more expensive. In another embodiment, the verification channel 603 may include the same components as the main and redundant channels 501 and 602. However, in various embodiments, the verification channel 603 is used only in or by the operation of the self-verification test system. Therefore, the components of the verification channel 603 are not used more frequently than the components of the main and / or redundant channels 601 and 602 which are constantly used throughout the operation of the generator, and therefore can remain more accurate and, for example, have less drift. In various embodiments, the verification channel 603 follows the same circuit as the main and redundant channels 601 and 602, but is separate from them, and in one embodiment is connected to the RF amplifier 40 and the RF output.

[0034] In various embodiments, channels 601, 602, and / or 603 include circuits comprising active and / or passive components and connected electrical paths arranged to transmit and / or measure RF energy supplied from the RF amplifier to and / or induced by the microcontroller. In various embodiments, one or more or all channels include and / or connected to one or more measuring circuits comprising sensors, detectors, comparators, resistors, and / or memories, and / or any combination thereof, configured to measure, calculate, and / or record the electrical properties (e.g., current, voltage, power, and / or phase) of the RF energy induced across one or more or all channels.

[0035] In various embodiments of the present invention, the electrosurgical generator 10 is further configured to provide an RF output in three resolution setting ranges, namely, low voltage, normal or medium voltage, and high voltage ranges. In various embodiments, a connectable electrosurgical hand device, e.g., instrument 20, and / or a connector coupled thereto, e.g., a device script stored and positioned on a device key 21, is used to determine or set the RF output or voltage mode.

[0036] In various embodiments, the electrosurgical generator 10 records all RF output data onto an internal memory device, such as a Secure Digital (SD) memory card or a non-volatile memory card. The memory device is configured to be readable on the electrosurgical generator 10 through an interface port 35, such as a Universal Serial Bus (USB) port (best illustrated in Figure 4). In various embodiments, the generator 10 is configured to copy the data from the internal memory device to a connectable portable storage device, such as a USB flash drive, through the generator's interface port.

[0037] Referring again to Figures 1 and 4-5, and in various embodiments, the electrosurgical generator 10 is configured to alert the surgeon when a blood vessel reaches a completed procedure state (e.g., a completed sealing state) or when an error condition or failure condition occurs. In various embodiments, the electrosurgical generator 10 may include visual, tactile, and / or audible outputs that supply such alerts or other indicators or information to the surgeon as instructed by a surgical procedure, device script, or health or operational information regarding the device 20 and / or the generator 10. In one embodiment, the generator 10 via a front panel interface 38 alerts the surgeon through an LCD display 14 integrated into the front panel of the generator, and in various embodiments, it supplies specific audible alarms or informational tones through a speaker 36 further integrated into the front panel of the generator. In various embodiments, the generator 10 may include a user interface or front panel overlay 39 that provides access, including push buttons for navigation, to allow user access to system settings such as volume or display brightness. The front panel overlay 39 may include a system power button or connectors. In various embodiments, a fan system 37 is provided to assist in heat dissipation. In addition, as shown in Figure 4-5, signal or sig represents a connection including a digital signal used to communicate information across the system and / or printed circuit board; power represents a connection including a voltage rail used to supply power to the system and / or printed circuit board; and RF represents a connection including high-voltage, high-current RF energy used to seal, dissolve, or cut tissue or blood vessels.

[0038] As further described above, in various embodiments, the electrosurgical generator 10 further includes a user-accessible power-on switch or button 18 accessible by the surgeon to power on or turn on the generator 10. In one embodiment, the power-on switch 18 is located on the front panel of the generator. In various embodiments, with the generator 10 powered on by the activation of the power-on switch 18, the generator 10 initiates or starts powering on the self-verification system test. During the self-verification system test, in various embodiments, the generator 10 verifies the adjustment of the RF output in one or more RF modes and / or one or more RF resolution setting values. In various embodiments, the RF adjustment modes include voltage, current, and power adjustment modes, and the RF resolution setting values ​​include low, normal, and high voltage settings.

[0039] Referring to Figure 7, a schematic diagram of an example of hardware resources implemented within the electrosurgical generator 10 for performing a self-verification system test is shown. As can be seen from this figure, one or more impedance loads 82 can be implemented within the RF amplifier 40 of the control system 100. In various embodiments, the control system 100 of the electrosurgical generator 10 may include one or more impedance loads 82 that are inside and / or integrated into the generator 10. It should be understood that the impedance loads 82 are not user-accessible and, in various embodiments, are used solely for performing a self-verification system test of the generator 10. One or more impedance loads 82 can be resistive, capacitive, inductive, or any combination thereof, according to embodiments of the present invention. The self-verification system test process utilizes the impedance loads 82 to verify the voltage, current, power, and / or phase measurements of the generator 10.

[0040] In some embodiments, the impedance load 82 is attached to or integrated with the RF amplifier 40. In other embodiments, various configurations of the impedance load 82 can be selected through one or more relays or switches 81. In one embodiment, the impedance load 82 is in a parallel configuration. In another embodiment, the impedance load 82 is in series, parallel, or a combination thereof to provide different load configurations or values ​​for other self-verification settings or tests.

[0041] The impedance load 82 is internal in embodiments of the present invention to avoid potential inaccuracies or errors resulting from the use of external impedance loads such as connections, e.g., cabling, load characteristics, e.g., phase changes, user errors, and various losses resulting from equipment tolerances or errors therein. An internal or integrated self-verification system including, but not limited to, the internal impedance load 82 also avoids the need for additional measuring instruments, e.g., oscilloscopes, or specialized instruments, e.g., test electrosurgical instruments or keys, or accessories, e.g., adapters, along with any potential inaccuracies associated with the use of such instruments. Likewise, any setting time or scheduling of time to perform such verification is also avoided through self-verification system testing that is automatically scheduled and executed.

[0042] Table I summarizes exemplary self-verification processes performed in various RF adjustment modes and RF resolution setpoints. In various embodiments, each processing step can have a specific adjustment value and impedance load configuration. After setting the adjustment value and activating the verification relay 81, the RF amplifier 40 generates an RF output and supplies the RF output to an internal impedance load 82 implemented within the RF amplifier 40, as induced by the self-verification system test. Accordingly, the control system 100 adjusts the RF output to the setpoint, and the feedback system 60 measures various electrical properties of the RF output from the main channel 601, redundant channel 602, and verification channel 603, and digitally feeds the measurements to the microcontroller 50 for further processing. The primary microcontroller 50 compares the measurement data or measurement readings from the main channel 601 and redundant channel 602 with the verification channel 603 and starts or stops the supply of RF energy accordingly.

[0043] [Table 1]

[0044] In various embodiments, to pass the self-verification test, the measurements of all feedback system channels 601, 602, and 603 must be compatible with each other and / or within a certain tolerance and / or conform to the target RF setting value. More specifically, the primary channel 601, redundant channel 602, and verification channel 603 must be within a certain tolerance of their nominal values ​​based on the internal load impedance configuration and the target RF setting value to prevent false positives when all readings of the three channels are identical but offset. For example, if all feedback system channels 601, 602, and 603 read or measure 20 volts from the RF output for a 60-volt test, the test will fail or not pass, even if the channels identify identical voltage measurements.

[0045] In various embodiments, after the electrosurgical generator 10 has passed top-level calibration and verification during the manufacturing process, an initial verification channel offset is calculated at the factory level. The initial offset value is calculated by comparing the redundant channel readings with the primary channel and verification channel readings and offsetting these readings relative to the verification values. As a result, this sets the primary channel, redundant channel, and verification channel readings to the same value. In various embodiments, the primary microcontroller 50 utilizes an ARM processor to internally apply these initial offsets to each verification test or process. Therefore, for example, if an internal impedance load, such as a shunt resistor, begins to drift after the initial offset adjustment in any of the primary channel 601, redundant channel 602, and verification channel 603, the generator 10's self-verification system test will identify the drift and / or otherwise indicate an error or failure.

[0046] In embodiments of the present invention, a failure of the self-verification system test will be displayed on the generator's LCD 14 and / or the generator 10 will cease to function so that RF energy is not supplied to the connected electrosurgical instrument 20. In various embodiments, the generator's power can cycle off and on, the self-verification system test will restart, and in various embodiments, after a predetermined number of failures in a particular sequence, for example, two consecutive verification failures, the electrosurgical generator 10 will fail or enter a non-functional state and will require maintenance before it can operate, for example, supply RF energy to the connected electrosurgical instrument 20.

[0047] With the self-verification system activated when the generator or system is powered on or started, the electrosurgical generator 10 is configured to notify the surgeon of any potential generator problems before any use of the connected electrosurgical instrument 20 or any supply of RF energy to tissue or blood vessels through the electrosurgical instrument 20.

[0048] Therefore, without a self-verification system during generator startup or power-on operation, conventional generators are unlikely to detect any RF output faults, if any, until the surgeon attempts to apply RF energy to the tissue. Accordingly, the electrosurgical generator 10 according to the embodiment of the present invention is configured to detect faults at startup or on a predetermined schedule, thereby reducing troubleshooting and surgical operation time and avoiding other potential surgical difficulties.

[0049] In various embodiments, the verification channel 603 has components with lower drift and higher resolution (higher quality and lower PPM / °C). Therefore, a lower thermal coefficient, which allows for the determination of component drift, ensures that the verification channel 603 resists changes over time and temperature. In addition, components of verification system channels 601, 602, and 603, such as shunt resistors, may drift over time due to heat generated by the RF output. This drift can distort measurements. However, since components of the verification channel 603, such as impedance loads, are not utilized during normal RF output operation, the verification channel 603 is more resistant to drift.

[0050] As further explained above, the verification channel 603 uses the normal RF output path, and the verification channel 603 then uses a resistor and capacitor inside the electrosurgical generator 10, for example, a relay 81 to an impedance load 82, to redirect the RF output path to the connected electrosurgical hand device 20 instead of the normal RF output path. In various embodiments, high-power loads, such as resistors, inductors, or capacitors, are used to withstand or resist adverse effects such as temperature introduced through the application of RF energy. In one embodiment, a high-power resistor is provided, and in other embodiments, there is a chassis mounted and positioned in the airflow path of the generator to enhance heat dissipation.

[0051] In some embodiments, the impedance load of the verification channel 603 is included on or integrated with the same circuit board as the other channels 601 and 602 of the feedback system 60, thereby reducing the overall footprint of the electrosurgical generator 10 or the feedback system 60. In other embodiments, the impedance load of the verification channel 603 is included on or integrated with a different circuit board, resulting in reduced influence of surrounding components on the heat generated by the impedance load. In various embodiments, for example, the impedance load can be varied, for example, a different value component, such as a resistor, or a different component, such as an inductor, which is used in place of a capacitor for phase measurement, increasing additional variation within the tuning mode being verified. In addition, the impedance load can be in series, parallel, or a combination thereof to provide a variety of load configurations or values.

[0052] In some embodiments, the verification channel measurement circuit is positioned in series with the RF output circuit to improve measurement accuracy and facilitate tracking or recording of such measurements. In other embodiments, the verification channel measurement circuit is isolated from the RF output circuit, for example, through a relay, and thus the resistance of the verification channel measurement circuit can be increased due to reduced operating time or thermal effects from supplying RF energy.

[0053] Next, referring to Figure 8, an embodiment of the operation or processing of the self-verification system according to an embodiment of the present invention is shown. The portion of processing 200 depicted begins in step 202, when the algorithm powers on the electrosurgical generator 10 at the starting point. After starting the generator 10, in step 204, a decision is made regarding whether the previous self-verification system test failed. If a failure of the previous self-verification system test is detected, the process flows from block 204 to block 206, where the process waits for a predetermined period (cool-down period) or power-on threshold, for example, 1 minute, before starting the self-verification system test in block 210. If a failure of the previous self-verification system test is not detected, the process proceeds from block 204 to block 208, where another decision is made regarding whether a predetermined period or power-on threshold has elapsed since the electrosurgical generator 10 was started.

[0054] If the power-on threshold is reached or exceeded, processing proceeds from block 208 to block 210 to start the self-verification system test. If the power-on threshold is not reached in block 208, processing proceeds to block 206 to wait for a predetermined period (cool-down period) or for the power-on threshold to elapse. Processing then proceeds to block 210 to start the self-verification system test.

[0055] With the self-verification system test initiated in block 210, the electrosurgical generator 10 is verified using various processing tests. After the completion of the self-verification system test, processing continues to block 212 to determine whether a fault in the electrosurgical generator 10 was detected during the self-verification process. If no fault is detected, processing proceeds from block 212 to block 214, where the electrosurgical generator 10 is configured to supply RF energy to the connected electrosurgical hand device 20. In this embodiment, the electrosurgical generator 10 can provide an indication that the electrosurgical device 20 can be connected to the generator 10 or that the device connected to the generator 10 is ready for surgical use or other indication. In other embodiments, device authentication and / or verification are also performed by the electrosurgical generator 10 before and / or after the generator 10 is verified by the self-verification system, and before the connected electrosurgical instrument 20 is ready for surgical use. In various embodiments of the present invention, processing determines that the electrosurgical generator 10 is fault-free if it passes one, two or more or all of the verification processes or tests without issue.

[0056] If a malfunction is detected in the electrosurgical generator 10, the process proceeds from block 212 to block 216, where another decision is made regarding whether a malfunction threshold has been reached. Using the malfunction threshold, the self-verification system determines, for example, whether a predetermined number of malfunctions have occurred, such as two or three consecutive times. If the malfunction threshold is reached, the process proceeds from block 216 to block 218, an error is generated, and the generator 10 becomes inoperable. In this embodiment, the electrosurgical generator 10 must be maintained in this inoperable state. In various embodiments of the present invention, the electrosurgical generator 10 notifies the user or surgeon of a generator error through audible, tactile, and / or visual indicators.

[0057] If the failure threshold is not reached in block 216, the process can then return to block 202, which restarts the electrosurgical generator 10, and attempt to verify the generator 10 again using the process. This process continues until no failure is detected in the electrosurgical generator 10 or the failure threshold is reached or exceeded.

[0058] Referring to Figure 9, a flowchart of an embodiment of process 210 for performing a self-verification system test is shown. Various self-verification process stages of RF adjustment mode and RF resolution setpoints are typically recorded or stored in the memory of the electrosurgical generator 10 of the present invention. Depending on the embodiment, each process stage may have specific adjustment values ​​and impedance load configurations. Exemplary self-verification processes are shown further earlier in Table I. After initiating the self-verification system test, the depicted portion of the process begins in block 302, where the algorithm sets the RF adjustment mode and RF resolution setpoints. Thus, the process is used to set the voltage mode, activate the appropriate relay 81 to obtain a specific load configuration, and set the adjustment values. The process then proceeds to block 304, which generates an RF output to supply RF energy to the verification system load. In various embodiments, the RF amplifier 40 generates an RF output to be induced by the self-verification system and supplies the RF output to an internal load 82 within the amplifier.

[0059] With the RF output generated, processing proceeds to block 306, where the feedback system 60 measures the electrical properties of the RF output. The control system 100 adjusts the RF output to a set value as induced by the self-verification system, according to various embodiments of the present invention, and the feedback system 60 measures voltage, current, power, and / or phase from the main channel 601, redundant channel 602, and verification channel 603. After measuring the electrical properties of the RF output, processing proceeds to block 308, where the primary microcontroller 50 performs calculation, comparison, and analysis of the measured data. In various embodiments, the feedback system 60 communicates the measured data and / or its real and imaginary parts for channels 601, 602, and 603 to the primary microcontroller 50 for further processing. In various embodiments, the primary microcontroller 50 compares the data or readings of the main channel 601 and redundant channel 602 with the verification channel 603. If the readings of the main channel and redundant channel are less than a predetermined tolerance or difference, for example, 5%, the self-verification process or test passes or is verified. Otherwise, the verification process or test fails. In various embodiments of the present invention, in both cases, the result is recorded or stored in the memory of the device key 21 of the electrosurgical generator 10 and / or electrosurgical instrument 20.

[0060] Block 310 determines whether the self-verification system test of the electrosurgical generator 10 is complete. If the self-verification system test is complete, processing flows from block 310 to block 312, exiting the self-verification process after a timestamp recording the test completion is generated. If the self-verification system test is not complete, processing then returns to block 302, which sets a new RF adjustment mode and a new RF resolution setting value. This process continues until all stages of the self-verification process that verify the electrosurgical generator 10 have been performed. In various embodiments, the self-verification system test is triggered under predetermined conditions and / or according to a predetermined schedule, for example, at each predetermined condition and / or selected interval, such as power-on, device connection and / or scripting, or device activation. In various embodiments, individual buttons or switches are provided on the generator, connectable device, and / or adapter used to trigger the self-verification test.

[0061] The electrosurgical generator 10 is configured to operate in one or more specific voltage modes according to embodiments of the present invention. In various embodiments, the voltage modes are low, medium, and high, and in various embodiments, the voltage modes adjust or achieve the feedback system 60. In various embodiments, the voltage modes determine the gain setpoint on the ADC (digital-to-analog converter) used in the feedback system 60, and in various embodiments, the high voltage has a maximum gain setpoint of 300V, the medium voltage has a maximum gain setpoint of 150V, and the low voltage has a maximum gain setpoint of 10V. Having different gain setpoints for different voltage modes increases the measurement resolution of the feedback system 60.

[0062] In embodiments of the present invention, the RF amplifier may include an autotransformer directly connected to the primary transformer of the RF amplifier to supply a high-voltage mode. In various embodiments, when the RF amplifier 40 is operating in high-voltage mode (autotransformer on), the RF output can reach up to 300V and 4A. On the other hand, when the autotransformer is off, the RF amplifier 40 can be operated in normal voltage mode, and the RF output is limited to 150V and 8A, and in low-voltage mode or passive mode, it is limited to 10V and 100mA.

[0063] In some embodiments, the self-verification system test involves changing the voltage mode to test or ensure that different gain setpoints are accurate across the main channel 601, redundant channel 602, and verification channel 603 of the feedback system 60. In other embodiments, different voltage, current, and power adjustment modes are also included, along with the various voltage modes used and tested in the self-verification system test.

[0064] In various embodiments of the present invention, the measured and calculated results obtained by the main channel 601 and redundant channel 602 are compared with the measured and calculated results obtained by the verification channel 603. If channels 601, 602, and 603 are all conforming and within the set tolerances in the various embodiments, the self-verification system test according to the embodiments of the present invention clears or enables the electrosurgical generator 10 to continue, and thus enables RF output to the connected electrosurgical device 20. The main channel 601, redundant channel 602, and verification channel 603 also need to be within the set tolerances compared to nominal adjustment values ​​in various embodiments to allow the verification system to clear the generator for operation.

[0065] In embodiments of the present invention, the low-voltage mode is used solely for passive measurement and does not set a constant voltage, current, or power. In various embodiments, the low-voltage mode also does not utilize the verification channel 603, and therefore the RF output is supplied at a low voltage. In this embodiment, voltage and current are measured, resistance is calculated, and some or all of the measured values ​​and test results are compared to predetermined values ​​and are within predetermined tolerances to further clear or enable the electrosurgical generator 10 for further operations.

[0066] In various embodiments, the self-verification system determines or checks the drift of sensing devices such as resistors, capacitors, or inductors in the main channel 601 and redundant channel 602, and the main channel 601 and redundant channel 602 are used to measure or calculate the electrical properties of the RF output. If the drift of these components is minimal or within a predetermined range and / or the units can be adjusted to set values, the RF output of the electrosurgical generator 10 is determined to be fault-free by the self-verification system test, and the self-verification process enables the generator 10 for further operational or surgical use.

[0067] Figure 10 shows a flowchart illustrating an exemplary method for performing a self-verification system test of the electrosurgical generator 10. This process or system test verifies that the electrosurgical generator 10 can output RF energy at a set value and that the feedback system 60 accurately measures this RF output across all channels 601, 602, and 603. In various embodiments of the present invention, the RF output is initially generated and therefore supplied to the self-verification system. In various embodiments, when the generator is powered on, for example, when the power button 18 on the front panel of the generator 10 is pressed, the generator 10 initiates the self-verification system process. This causes the RF output to be supplied to or induced to an internal load rather than through the connected electrosurgical device 20. As shown in Figure 10, the self-verification process is thought to bypass or power off relays 1 and 2, which would then induced the RF output or electrosurgical energy to the connected electrosurgical device, e.g., the dissolution device 20. It should be understood that the electrosurgical device does not need to be connected to the electrosurgical generator 10 for the self-verification system to operate or proceed with its process. Therefore, processing is switched to internal loads as guided by the self-verification system.

[0068] As shown in Figure 10, relays 6-8 are turned on / off in various sequences to provide the associated internal load configuration as needed. In various embodiments, relays 6 and 7 can be activated or used simultaneously and in parallel to help dissipate power and / or heat. Relay 8, on the other hand, is turned on or used in various embodiments to include phase variations as desired. When a higher voltage RF output is required, relays 4 and 5 in the exemplary embodiment are used to switch to a high-voltage transformer. Relay 3 is used or activated in various embodiments to provide a return path or to complete the circuit of the self-verification system. In various embodiments of the present invention, the self-verification system may include a plurality of relays and loads, including, for example, resistors, capacitors, inductors, and various combinations thereof, and other relays, loads, and combinations thereof are not shown for ease of reading. In some embodiments, the self-verification system may include a timer to ensure that the self-verification system test is not activated or started unnecessarily or is activated as intended. Therefore, if the electrosurgical generator 10 is turned on and off quickly, for example in less than one second, the self-verification system will not be activated, preventing potential thermal damage to loads such as resistors in various embodiments. In other embodiments, a timer is configured to start at or near the power-on time and to reach or pass a predetermined threshold to trigger or initiate the activation of the self-verification system.

[0069] The above description is provided to enable any person skilled in the art to fabricate and use an electrosurgical device or system to carry out the method described herein, and describes the best mode of carrying out the invention as envisioned by the inventors. However, various modifications will remain as obvious to those skilled in the art. These modifications are intended to be within the scope of the disclosure of the invention. Different embodiments or aspects of such embodiments can be shown and described in various figures throughout this specification. However, it should be noted that each embodiment and aspect thereof, although shown or described separately, can be combined with one or more of the other embodiments and aspects thereof unless explicitly stated otherwise. Each combination is not explicitly described solely for the sake of readability of this specification.

[0070] Although the present invention has been described in certain aspects, many additional modifications and changes will be apparent to those skilled in the art. Therefore, it should be understood that the present invention can be implemented in ways other than those specifically described, including various variations in size, shape, and material, without departing from the scope and spirit of the invention. Accordingly, the embodiments of the present invention should be considered in all respects as illustrative and not limiting. [Explanation of Symbols]

[0071] 200 Self-verification system operation or processing 202 The stage of powering on the electrosurgical generator. 204 Stage providing a determination of whether the previous self-verification system test failed. 206 Blocks that wait for a predetermined period of time or a power-on threshold to elapse. 210 Block to start self-verification system testing

Claims

1. A method for performing an automated verification and self-verification system for an electrosurgical generator before performing a surgical procedure, The stage in which a self-verification system test is initiated after it is determined that a predetermined period has elapsed when the electrosurgical generator is started, After the step of initiating the self-verification system test, there is a step of setting the RF adjustment mode from multiple RF adjustment modes and setting the RF resolution setting value from multiple RF resolution setting values. A step of generating RF energy based on the set RF adjustment mode and RF resolution setting value, wherein the generated RF energy is directed to a plurality of impedance loads within the electrosurgical generator. The steps include: measuring the electrical properties of the generated RF energy across the plurality of impedance loads; and analyzing the measured electrical properties. A step of determining whether the self-verification system test has been completed across the plurality of RF adjustment modes and the plurality of RF resolution setting values, The step includes recording a self-verification system test completion timestamp upon completion of the self-verification system test, method.

2. The method according to claim 1, further comprising the step of repeating the setting step, the generating step, the measuring step, and the analysis step until the completion of the self-verification system test is determined.

3. The method according to claim 2, wherein the completion of the self-verification system test is determined when all self-verification processing steps are completed across the plurality of RF resolution setpoints and the plurality of RF adjustment modes.

4. The method according to any one of claims 1 to 3, further comprising the step of starting to supply the generated RF energy to a connected electrosurgical hand device if no generator malfunction is detected during the self-verification system test.

5. The method according to any one of claims 1 to 3, further comprising the step of generating a system error when a generator failure is detected during the self-verification system test and a failure threshold is reached.

6. The method according to claim 5, wherein the fault threshold is reached when the self-verification system test detects the generator fault for a specified number of consecutive times, the specified number of consecutive times being at least two.

7. The method according to any one of claims 1 to 6, wherein the measuring step is performed using a plurality of feedback system channels of the electrosurgical generator, and the measuring step includes the steps of measuring the electrical properties of the RF energy generated across the feedback system channels, and communicating the real and imaginary components of each of the feedback system channels to the microcontroller of the electrosurgical generator.

8. The method according to claim 7, wherein the analysis step is performed by the microcontroller of the electrosurgical generator, and the analysis step includes receiving the real and imaginary components of the measured electrical properties, performing a power calculation, and comparing the measured values ​​of the feedback system channel to determine whether a generator fault is present.

9. The method of claim 8, wherein the generator fault exists when the measured values ​​of the feedback system channels do not fit together and / or are not within a certain intersection of the plurality of RF adjustment modes and the plurality of RF resolution setpoints.

10. The method according to claim 8, wherein the microcontroller starts or stops supplying the generated RF energy to the connected electrosurgical hand device based on the results of the comparison.

11. The method according to any one of claims 7 to 10, wherein the feedback system channel includes a primary channel, a redundant channel, and a verification channel.

12. The method according to claim 11, wherein the main channel and the redundant channel are used throughout both the operation of the electrosurgical generator and the self-verification system test, while the verification channel is used only during the self-verification system test.

13. The method according to claim 11, wherein the step of generating the RF energy is performed by the RF amplifier of the electrosurgical generator, and during the self-verification system test, each of the feedback system channels measures the electrical properties of the generated RF energy across the plurality of impedance loads.

14. The method according to any one of claims 1 to 13, further comprising the step of storing the results obtained from the measuring step and the analysis step in the memory of the electrosurgical generator.

15. The method according to any one of claims 1 to 14, wherein the plurality of RF resolution setting values ​​include at least one of a low voltage setting value, a medium voltage setting value, and a high voltage setting value.

16. The method according to claim 15, wherein the low voltage setting has a maximum output RF energy of 10V or 100mA, the medium voltage setting has a maximum RF output energy of 150V or 8A, and the high voltage setting has a maximum output RF energy of 300V or 4A.

17. The method according to claim 15, wherein for each RF resolution setting value, the plurality of RF adjustment modes include at least one of a voltage adjustment mode, a current adjustment mode, and a power adjustment mode.

18. The steps involve selecting the RF adjustment mode from multiple RF adjustment modes and setting the RF resolution setting value from multiple RF resolution setting values. The stage of setting predetermined RF adjustment values, and This includes the step of activating the appropriate relay to obtain a specific impedance load configuration, The method according to any one of claims 1 to 17.

19. The method according to claim 18, wherein the plurality of impedance loads include relays on at least one or two for providing selective connections between a plurality of resistors, capacitors, or inductors.

20. The method according to any one of claims 1 to 19, wherein the plurality of impedance loads are located inside or integrated into the electrosurgical generator and are used solely for performing the self-verification system test when the electrosurgical generator is started.

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