Devices, systems, and methods for calculating the total amount of energy delivered to tissues during electrosurgical treatment.

Abstract

This disclosure relates to apparatus, systems, and methods for calculating the total amount of energy delivered to tissue during electrosurgical treatment. The disclosure provides an energy supplier that supplies electrosurgical energy to an applicator via a radio frequency (RF) output stage, a memory storing at least one energy quantization function that determines the total amount of energy delivered by the applicator to patient tissue, and a controller that controls the energy supplier based on a selected power setting and determines the total amount of energy delivered to patient tissue according to the energy quantization function and the selected power setting. The controller calculates the energy delivered to patient tissue based on the selected power setting and the duration of activation of the applicator at the selected power setting, and displays the delivered energy in joules.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 945,142, filed December 7, 2019, entitled “Apparatus, System, and Method for Calculating the Total Amount of Energy Delivered to Tissue During Electrosurgical Treatment,” the contents of which are incorporated herein by reference in their entirety. background Technical Field

[0004] This disclosure generally relates to electrosurgery and electrosurgery systems and apparatus, and more specifically, to apparatus, systems and methods for calculating the total amount of energy delivered to tissues during electrosurgery treatment. Background Technology

[0006] High-frequency electrical energy has been widely used in surgery and is often referred to as electrosurgical energy. Electrosurgical energy is used to cut tissue and coagulate bodily fluids.

[0007] Electrosurgical instruments typically consist of either "monopolar" or "bipolar" devices. A monopolar device comprises an active electrode on the electrosurgical instrument and a return electrode attached to the patient. In monopolar electrosurgery, electrosurgical energy flows through the active electrode on the instrument and through the patient's body to the return electrode. This type of monopolar device is effective in surgical procedures requiring tissue cutting and coagulation where stray currents do not pose a significant risk to the patient.

[0008] Bipolar devices consist of an active electrode and a return electrode on the surgical instrument. In a bipolar electrosurgical device, electrosurgical energy flows through the active electrode to the patient's tissue, and then over a short distance to the return electrode. The electrosurgical effect is essentially limited to a small area of ​​tissue between the two electrodes positioned on the surgical instrument. Bipolar electrosurgical devices have been found effective in surgical procedures or other processes where stray currents could be harmful to the patient and proximity to both the active and return electrodes is required. The methods and procedures involved in bipolar electrosurgery often need to differ significantly from those involving monopolar electrosurgery.

[0009] Gas plasma is an ionized gas capable of conducting electrical energy. Plasma is used in surgical devices to deliver electrosurgical energy to the patient. Plasma conducts energy by providing a relatively low-resistance path. The electrosurgical energy is used to cut, coagulate, dry, or electrocauterize the patient's blood or tissue via the plasma. No physical contact is required between the electrodes and the treated tissue.

[0010] Electrosurgical systems that do not include a controlled gas source can ionize the ambient air between the active electrodes and the patient. The resulting plasma will conduct electrosurgical energy to the patient, although the plasma arc typically appears more spatially dispersed compared to systems with a controlled flow of ionizable gas.

[0011] The total amount of energy delivered to patient tissue by plasma output from an electrosurgical system (e.g., via an applicator or handheld device) differs from the total amount of energy generated and output by the electrosurgical generator of the electrosurgical system. Among other inefficiencies, some energy output by the electrosurgical generator is lost during plasma beam generation. Understanding the total amount of energy delivered to patient tissue, and not just the total amount of energy output by the system's electrosurgical generator, is useful for producing the desired results in a given treatment. However, currently used electrosurgical systems do not provide a simple and efficient method for accurately measuring the energy delivered to patient tissue. Therefore, apparatus, systems, and methods for calculating the total amount of energy delivered to patient tissue are needed. Summary of the Invention

[0012] This disclosure relates to apparatus, systems, and methods for calculating the total amount of energy delivered to tissues during electrosurgical treatment.

[0013] According to one aspect of this disclosure, an electrosurgical generator is provided, comprising an energy supply unit that supplies electrosurgical energy to an applicator via a radio frequency (RF) output stage; a memory storing at least one energy quantization function that determines the total amount of energy delivered to patient tissue by the applicator; and a controller that determines the total amount of energy delivered to patient tissue based on the energy quantization function and the output power of the RF output stage.

[0014] On the one hand, the output power is determined based on the selected generator power setting.

[0015] On the other hand, the output power is determined based on sampling the output voltage and output current of the RF output stage.

[0016] On the other hand, the electrosurgical generator also includes an input / output interface that receives input for selecting the generator power settings.

[0017] On the other hand, the electrosurgical generator also includes an input / output interface that displays the total amount of energy delivered to the patient's tissues.

[0018] On the one hand, the total amount of energy delivered to the patient's tissues is expressed in joules.

[0019] In another aspect, the controller calculates the energy delivered to the patient's tissue based on the selected power setting and the duration of the applicator's activation at the selected power setting.

[0020] In another aspect, the electrosurgical generator also includes at least one sensor coupled to the output of the RF output stage, the sensor being configured to sample the voltage and / or current of the RF output stage and provide the sampled voltage and / or current to the controller.

[0021] On the other hand, the selected generator power setting is used to determine the energy delivered based on the sampling voltage and / or sampling current of the RF output stage.

[0022] On one hand, the electrosurgical generator also includes at least one sensor that measures impedance at the RF output stage and provides the measured impedance to a controller, which determines whether the applicator is applying energy to the patient tissue based on the measured impedance and adds the delivered energy to the count only when the applicator is applying energy to the patient tissue.

[0023] On the other hand, the electrosurgical generator also includes an input / output interface that allows selection of the energy endpoint for the procedure, wherein when the count exceeds the energy endpoint, the controller stops supplying electrosurgical energy to the applicator.

[0024] On the one hand, when the count exceeds the energy endpoint, the controller triggers a notification through the input / output interface.

[0025] On the other hand, when the count exceeds the energy endpoint, the controller triggers a notification and sends the notification to an external device via the communication module.

[0026] On the other hand, the memory stores a predetermined energy endpoint for each of the multiple surgeries.

[0027] On another front, the input / output interface can select at least one of a plurality of procedures, wherein when at least one procedure is selected, the controller retrieves the corresponding energy endpoint from memory.

[0028] In another aspect, the electrosurgical generator also includes a communication module that receives predetermined energy endpoints from external devices for each of the multiple surgeries.

[0029] On the other hand, at least one energy quantization function is selected based on the type of applicator.

[0030] On one hand, when the applicator is connected to at least one jack, at least one energy quantization function is received from the applicator.

[0031] In another aspect, the electrosurgical generator also includes an input / output interface capable of storing in memory the total count of energy delivered as energy endpoints to the patient's first treatment area, wherein when surgery is performed on the patient's contralateral treatment area, the controller retrieves the stored energy endpoints from memory.

[0032] In one aspect, when performing surgery on the patient's first treatment area, the controller determines the total amount of energy delivered to the patient's tissue and stores the determined total amount of energy in a memory as the energy endpoint for surgery on the patient's contralateral treatment area.

[0033] In another aspect, the electrosurgical generator also includes an input / output interface that can select surgery for the contralateral treatment area, wherein when surgery is selected, the controller retrieves the stored energy endpoint from the memory.

[0034] According to one aspect of this disclosure, the electrosurgical generator further includes a flow controller for supplying at least one gas to the applicator, wherein the applicator generates plasma from electrosurgical energy and at least one gas, the plasma being delivered to patient tissue.

[0035] In one aspect, the controller counts the energy delivered to the patient's tissue based on at least one of the type of at least one gas, the flow rate of at least one gas, and / or the power setting of the electrosurgical setup.

[0036] On the other hand, the electrosurgical generator also includes an input / output interface that displays the meter reading of the energy delivered to the patient's tissue, wherein the meter reading of the energy delivered to the patient's tissue is displayed in joules.

[0037] On the other hand, the electrosurgical generator also includes an input / output interface that displays the total amount of energy delivered to the patient's tissue, wherein the total amount of energy delivered to the patient's tissue is displayed in joules per second.

[0038] According to another aspect of this disclosure, a method for performing a medical procedure is provided, comprising applying electrosurgical energy to patient tissue via an electrosurgical generator; determining the total amount of energy delivered to the patient tissue based on at least one energy quantization function and the output power of the electrosurgical generator; comparing the determined total amount of delivered energy with an energy endpoint; and stopping the application of electrosurgical energy when the determined amount of energy delivered reaches or exceeds the energy endpoint.

[0039] In one aspect, the method also includes displaying the total amount of energy delivered to the patient's tissue via the input / output interface of the electrosurgical generator.

[0040] On the other hand, the total amount of energy delivered is the instantaneous energy delivered in joules per second.

[0041] On the other hand, the total amount of energy delivered is shown as a cumulative count of delivered energy in joules.

[0042] In another aspect, the method also includes triggering a notification when the total amount of energy delivered reaches or exceeds the energy endpoint.

[0043] In one aspect, the method also includes storing in memory a predetermined energy endpoint for each of the multiple surgeries.

[0044] In another aspect, the method also includes selecting at least one procedure and retrieving the corresponding energy endpoint from the memory.

[0045] On the other hand, the application also includes: providing electrosurgical energy to the patient tissue via a medicator connected to the electrosurgical generator, providing at least one gas to the medicator, and generating plasma from the electrosurgical energy and at least one gas to be delivered to the patient tissue.

[0046] On the one hand, the at least one energy quantification function is based on at least one of the type of applicator, the type of the at least one gas, and / or the flow rate of the at least one gas.

[0047] In another aspect, the method further includes, after completing surgery on the first treatment area of ​​the patient, determining the total amount of energy delivered to the patient's tissue and storing the determined total amount of energy in a memory as an energy endpoint for surgery on the contralateral treatment area of ​​the patient.

[0048] In another aspect, the method also includes selecting a surgical site for the contralateral treatment area and retrieving a stored energy endpoint from the memory. Attached Figure Description

[0049] The above and other aspects, features and advantages of this disclosure will become more apparent from the following detailed description taken in conjunction with the accompanying drawings, wherein:

[0050] Figure 1 This is an illustration of an electrosurgical system according to an embodiment of the present disclosure;

[0051] Figure 2A According to embodiments of this disclosure Figure 1 A front view of the electrosurgical generator of an electrosurgical system;

[0052] Figure 2B According to embodiments of this disclosure Figure 1 A block diagram of the electrosurgical generator in an electrosurgical system;

[0053] Figure 3 This illustrates an embodiment of the present disclosure for determining the calculation of... Figure 1 A flowchart illustrating the method for calculating the total amount of energy delivered to the patient's tissue by the applicator of an electrosurgical system.

[0054] Figure 4 This describes an embodiment of the present disclosure for calculating... Figure 1 A flowchart illustrating the method for delivering the total amount of energy to the patient's tissue using the applicator of an electrosurgical system;

[0055] Figure 5 Exemplary results of a method for determining an equation for calculating the total amount of energy delivered to a patient's tissue by an applicator of an electrosurgical system, according to embodiments of the present disclosure, are shown.

[0056] Figure 6 A graph for determining the Joule counter equation according to embodiments of the present disclosure; and

[0057] Figure 7 This is a flowchart illustrating a method of applying electrosurgical energy to different sites on a patient using an electrosurgical system according to an embodiment of the present disclosure.

[0058] It should be understood that the accompanying drawings are for illustrating the concepts of this disclosure and are not necessarily the only possible configurations of this disclosure. Detailed Implementation

[0059] Preferred embodiments of the present disclosure will now be described with reference to the accompanying drawings. In the following description, well-known functions or configurations are not described in detail to avoid unnecessarily obscuring the present disclosure. In the drawings and the following description, the term "proximal end," as conventionally used, will refer to the end of the device (e.g., an instrument, apparatus, applicator, handheld device, tweezers, etc.) closer to the user, while the term "distal end" will refer to the end farther from the user. Here, the phrase "connection" is defined as indicating a direct connection or an indirect connection via one or more intermediate components. Such intermediate components may include hardware-based and software-based components.

[0060] Those skilled in the art will understand that the block diagrams presented herein represent conceptual views of illustrative circuits embodying the principles of this disclosure. Similarly, it should be understood that any flowchart, diagram, state transition diagram, pseudocode, etc., representing various processes that can exist substantially in a computer-readable medium and therefore be executed by a computer or processor, whether or not such a computer or processor is explicitly shown.

[0061] This disclosure relates to apparatus, systems, and methods for calculating the total amount of energy delivered to tissues during electrosurgical treatment.

[0062] refer to Figure 1 The image shows an electrosurgical system 1 according to the present disclosure. System 1 includes an applicator or handheld device 10 and an electrosurgical generator unit (ESU) 50. In some embodiments, system 1 also includes a gas supply unit 70.

[0063] The applicator 10 is configured to receive electrosurgical energy from the ESU 50 via cable 20. The applicator 10 is also configured to receive inert gas from a gas source 70. In some embodiments, the inert gas is received from a gas supply 70 and supplied to the applicator 10 from the ESU 50 via cable 20. It should be understood that the gas supply 70 may be inside or outside the ESU 50. In other embodiments, the applicator 10 receives inert gas directly from the gas supply 70. The applicator 10 includes a handle housing 12 with a button 18 and a shaft 14 with a distal end 16. When the button 18 is pressed, electrosurgical energy is delivered to the applicator 10 via the ESU 50, and inert gas is delivered to the applicator 10 via the gas source 70. The electrosurgical energy is used to excite electrodes disposed in the shaft 14. As the inert gas passes through the excited electrodes, plasma is generated and emitted from the end 16 to the patient tissue, allowing radio frequency (RF) energy to be conducted from the electrodes 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 into plasma with very little energy; however, other inert gases, such as argon, are considered to be within the scope of this disclosure. Furthermore, mixtures of inert gases can be used to generate plasma. An exemplary applicator is shown and described in commonly owned U.S. Patent No. 9,060,765, the contents of which are incorporated herein by reference.

[0064] It should be understood that in some embodiments, the applicator 10 may be configured to apply or deliver energy to patient tissue in a manner or form different from plasma. For example, the applicator 10 may deliver RF energy to patient tissue through direct contact between electrodes and patient tissue. In some embodiments, the electrodes may be retractable within the shaft 14 to extend and be used for direct contact with patient tissue to deliver RF energy or to retract 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 patient tissue through the heating element.

[0065] refer to Figure 2AThe diagram shows a front view of an ESU 50 according to an embodiment of the present disclosure. In one embodiment, the ESU 50 includes a high-frequency electrosurgical generator 61 and a gas flow controller 62 contained in a single housing 63. The ESU 50 includes a front panel 19, which includes input / output portions 21, such as a touchscreen, for inputting commands / data into the ESU 50 and for displaying data. The front panel 19 may also include various level controllers 22 with corresponding indicators 24. Furthermore, the ESU 50 includes a jack portion 26 (which may include an on / off switch 28), a return electrode jack 30, a single-pole foot switch jack 32, a single-pole manual switch jack 34, and a double-pole manual switch jack 36. The gas flow controller 62 includes a gas jack portion 38, which may also include a gas A input jack 40 and a gas B input jack 42. The gas flow controller 62 may also include a user interface portion 44, which includes a selector switch or input 46 and a display 48. The selector switch or input 46 can select the type of gas being input, the gas mixture being input, the composition and / or percentage of the gas mixture being input, the flow rate of the gas applied to the handheld device or applicator, etc. It should be understood that, although... Figure 2A A high-frequency electrosurgical generator 61 and a gas flow controller 62 are shown housed in a single housing 63, but the gas flow controller 62 may be provided as a separate external device that connects to the ESU 50 via a wired and / or wireless interface.

[0066] refer to Figure 2B The diagram illustrates a block diagram of an ESU 50 according to an embodiment of the present disclosure. The ESU 50 includes a controller or processor 51, a power supply 52, a radio frequency (RF) output stage 54, an input / output (I / O) interface 56, an alarm 58, a memory 60, a flow controller 62, a sensor 64, and a communication module 66. The controller 51 is configured to control the power supply 52 to supply electrosurgical energy, which is output from the RF output stage 54 to the applicator 10 via at least one conductor extending through a cable 20. It should be understood that the cable 20 can be connected to the ESU 50 via a single-pole manual switch jack 34 or a double-pole manual switch jack 36. The input / output interface 56 is configured to receive user input to be provided to the controller 51 (e.g., via one or more buttons 22, 46, or a touchscreen 21, etc., disposed on the housing of the ESU 50) and output information received from the controller 51 (e.g., data output to an indicator 24, a graphical user interface output to the touchscreen 21, etc.). The audible alarm 58 can be controlled by the controller 51 to alert the operator to various situations or events.

[0067] Flow controller 62 is configured to control the flow rate of gas received from supply 70 to applicator 10. Flow controller 62 is coupled to controller 51 and receives control signals from controller 51 based on user input via input / output interface 56, selector switch, or input 46, or based on algorithms or software functions stored in memory 60. Additionally, flow controller 62 may include suitable sensors to determine the type of gas input to jacks 40, 42. Furthermore, flow controller 62 can use the input gas to generate a gas mixture to be supplied to the applicator. Although in Figure 2B In the illustrated embodiment, the flow controller 62 is located within the ESU 50, but the flow controller 62 may be located outside the ESU 50 and may be located, for example, in a separate housing, in the applicator 10, etc.

[0068] The ESU 50's communication module 66 is configured to communicate with other devices (e.g., client devices, servers, etc.) via a communication link (e.g., wired or wireless) to send and receive data and information. Although in Figure 2B In the illustrated embodiment, the operator is alerted to various situations via an audible alarm 58. However, in other embodiments, the controller 51 may use a communication module 66 to send notifications to at least one other device via a communication link (e.g., wired or wireless), where the information is associated with various conditions or events. The communication module 66 may be a modem, network interface card (NIC), wireless transceiver, etc. The communication module 66 will perform its function via hardwired connections 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 appropriate communication port configurations disposed on the surface of the housing 63. Wireless connections may operate under any of a variety of wireless protocols, including but not limited to Bluetooth. TM Interconnection, infrared connection, radio transmission connection, including computer digital signal broadcasting and reception commonly referred to as Wi-Fi or 802.11.X (where x represents the transmission type), satellite transmission, or any other type of communication protocol, communication architecture, or system currently existing or under development for wireless data transmission, including spread spectrum 900MHz or other frequencies, Zigbee, and / or any wireless communication supporting mesh networks.

[0069] In one embodiment, sensor 64 of ESU 50 is coupled to the output of RF output stage 54. Sensor 64 is configured to sample the voltage and / or current (or any other electrical characteristic) of the output of stage 54 and provide the sampled voltage and / or sampled current to controller 51. Controller 51 can use this information to determine one or more attributes associated with the power supplied by ESU 50 to applicator 10. In one embodiment, sensor 64 may include at least one voltage sensor for sensing the output voltage and at least one current sensor for sensing the output current. Optionally, sensor 64 may include at least one analog-to-digital converter for converting the sensed signal into a digital signal for input to controller 51; or, at least one analog-to-digital converter may be provided on controller 51.

[0070] In one embodiment, controller 51 is configured to determine the total amount of energy delivered to patient tissue by applicator 10 during treatment, for example, in joules. Controller 51 executes an energy quantification algorithm or function (e.g., stored in memory 60 of ESU 50) that enables controller 51 of ESU 50 to determine the total amount of energy delivered to patient tissue by applicator 10 over a period of time. The algorithm or function utilizes an equation or lookup table to determine the energy delivered to the tissue. As described below, in one embodiment, the equation is based on the results of calorimeter measurements.

[0071] It should be understood that Figure 1 and 2A The functionality of ESU 50 shown in -B can be implemented using dedicated hardware and hardware capable of executing software associated with appropriate software. In one embodiment, some or all of the functionality of controller 51 can be executed by at least one processor, such as a computer or electronic data processor, digital signal processor, or embedded microcontroller, field-programmable gate array (FPGA), unless otherwise specified, executed according to encoding, such as computer program code, software, firmware, register transfer logic, and / or integrated circuits encoded to perform such functionality. When implemented by a processor, the functionality can be implemented by a single dedicated processor, a single shared processor, or multiple separate processors, some of which may be shared. Furthermore, the explicit use of the terms "processor" or "controller" should not be construed as specifically referring to hardware capable of executing software, and may imply, but is not limited to, digital signal processor (DSP) hardware, read-only memory (ROM), random access memory (RAM), and non-volatile memory for storing software and / or firmware.

[0072] refer to Figure 3 According to embodiments of the present disclosure, a method 100 is shown for determining an equation for calculating the total amount of energy delivered by the applicator 10 to the patient's tissue.

[0073] In step 102, a predetermined volume of fluid (e.g., saline) is placed in a calorimeter. In step 104, the calorimeter is used to measure the baseline temperature of the fluid volume. In step 106, a first generator setting is selected, for example via touchscreen 21 or a suitable level controller 22, and plasma energy (or other types of energy, such as RF energy through direct contact between electrodes and the fluid volume, thermal energy through direct contact between electrodes or heating elements and the fluid volume, etc.) is applied to the fluid volume using the applicator 10 for a predetermined time period or length of time. It should be understood that the distal end 16 can be held at any distance within this sufficient distance without causing additional heat to be delivered to the fluid (or patient tissue), provided that the distal end 16 is held at a sufficient distance from the surface of the fluid volume (or to the patient tissue) to allow a plasma arc to occur between the distal end 16 and the surface of the fluid (or to the patient tissue). Thus, once within a sufficient distance, the end 16 can be placed closer or further from the fluid surface or patient tissue without altering the amount of heat delivered. It should be understood that the generator setting of ESU 50 represents the total amount of power delivered to the applicator 10 by ESU 50 (e.g., from RF output stage 54). In one embodiment, the power setting is expressed as a percentage of the maximum power that can be delivered to the applicator 10 by ESU 50. For example, in one embodiment, the maximum output power that can be delivered to the applicator 10 by ESU 50 may be 40 watts (W). Therefore, setting ESU 50 to 20% will result in 20% of the 40W output (i.e., 8W).

[0074] In step 108, a calorimeter is used to measure the temperature of the fluid volume after a predetermined time period of plasma energy application. In step 110, the total energy delivered to the fluid volume by the applicator 10 is calculated by calculating the total energy required to increase the temperature of the known volume of fluid from the baseline temperature measured in step 104 to the temperature measured in step 108 after the predetermined time period. Data from steps 104-110 is recorded in an energy delivery graph or table (e.g., stored in memory, such as memory 60). In one embodiment, the temperature measured in step 108 is input to ESU 50, for example, via input / output section 21. The total energy required to increase the temperature of the known volume of fluid from the baseline temperature measured in step 104 to the temperature measured in step 108 can then be calculated by an algorithm or function stored in memory 60 and executed by controller 51. In this way, the energy delivery graph or table can be generated by controller 51 and stored in memory 60 for later use.

[0075] In step 112, a new generator setting is selected via input / output section 21 or appropriate level controller 22 (e.g., in one embodiment, increasing the delivered power percentage by a predetermined increment), and steps 104-112 are performed until the maximum power setting of ESU 50 is reached. In this way, the energy delivery chart includes the total amount of energy delivered over a predetermined time period at multiple different generator settings of ESU 50. In step 114, an energy delivery (or Joule counter equation) chart is generated based on the data collected in steps 104-112, and (at least in part) based on the energy delivery chart, an equation for calculating the total amount of energy delivered by applicator 10 to patient tissue, such as an energy quantification function, the details of which will be incorporated below. Figure 5 and 6 Detailed description.

[0076] It should be understood that method 100 can be used to determine equations, such as an energy quantification function, for calculating the total amount of energy delivered to the patient tissue via any energy delivery device (e.g., RF energy delivery via a plasma arc between the end 16 and the fluid or patient tissue, RF energy delivery via direct contact between the electrodes of the applicator 10 and the fluid or patient tissue, and thermal energy delivery via direct contact between the heating element of the applicator 10 and the fluid or patient tissue).

[0077] In one embodiment, the equation determined in step 114 is as follows:

[0078] Y = AX + B (Equation 1) (For x, x >= 10 and <= 100) (1)

[0079] In Equation 1 above, Y equals the energy delivered per second by the applicator 10 to the patient tissue, X is the generator power setting (e.g., a percentage of the maximum power that can be delivered to the applicator 10 by the ESU 50), and A and B are constants determined based on the energy delivery chart constructed in step 114 of method 100. It should be understood that constants A and B will vary depending on the electrical characteristics of the ESU 50 and the applicator 10. Therefore, when the ESU 50 is used with applicators 10 having different electrical characteristics, the memory 60 of the ESU 50 can store different values ​​of constants A and B associated with each different applicator 10 that can be used with the ESU 50. Alternatively, the connector for each applicator may include a memory that stores constants A and B and transmits these constants to the controller 51 when the application is coupled to the ESU 50.

[0080] Figure 3 Exemplary results of the method are shown in Figure 5 and Figure 6 In. The results of steps 104 to 112 of method 100 are in Figure 5 As shown in the diagram. For each generator power setting 302, the measured temperature change (ΔT) 304 of the fluid (e.g., brine) is recorded. The energy delivered to raise the brine temperature 306 for each generator power setting 302 is then calculated using the following formula:

[0081] E S =ΔTxHxDxV (2)

[0082] Where ΔT is the measured temperature change of 304, H is the heat capacity of the brine (J / kg K) = 4150, D is the density of the brine (kg / L) = 1.0046, and V is the volume of the brine (mL) = 30. The calculation is for the increase in brine temperature (E). S The energy of 306 is then used to calculate the energy delivered to the patient's tissue per second using the following formula:

[0083] E P =E S / Activation time (3)

[0084] The activation time is 40 seconds. Then, for each generator power setting 302, the energy E delivered to the patient tissue is plotted. P 308 data, such as Figure 6 As shown. A linear best-fit line is applied to the data. The slope of the best-fit line = A, and the y-intercept of the best-fit line = B. For Figure 5 The data shown are A = 26.76 and B = -2.1561. Using Equation 1 and the determined constants A and B, the energy E delivered to the tissue can be determined for a given generator power setting X. P 308.

[0085] It should be understood that other variables or factors may be considered when determining the energy quantization function or energy delivery chart of this disclosure. In one embodiment, method 300 may be performed using different types of inert gases, and an energy quantization function may then be generated and stored for each type of gas. In another embodiment, method 300 may be performed using different gas mixtures, and an energy quantization function may then be generated and stored for each gas mixture. For example, the density of the gas mixture may be determined based on the composition of the mixture and the density of each gas. The density of the gas mixture may then be used to select an appropriate energy quantization function or energy delivery chart. It should be understood that the density of the gas mixture may be selected via input section 21, selector input 46, or may be automatically determined by ESU 50, for example, by flow controller 62 in conjunction with appropriate sensors. In another embodiment, method 300 may be performed using different flow rates of a predetermined gas, and an energy quantization function may then be generated and stored for each flow rate of the predetermined gas. It should be understood that a single variable or various combinations of variables may be used to generate and select an appropriate energy quantization function or energy delivery chart. For example, when selecting the gas type and flow rate, controller 51 may select a corresponding energy quantization function or energy delivery chart. In another example, after selecting the gas mixture and flow rate, controller 51 can select the corresponding energy quantization function or energy delivery chart.

[0086] In one embodiment, the controller or processor 51 of the ESU 50 is configured to determine (e.g., based on user input received via interface 56, or automatically by communicating with the memory or processor of the applicator 10) the type of applicator 10 coupled to the ESU 50, and to use appropriate constants A and B in Equation 1. For example, in one embodiment, A = 26.76 and B = -2.1561. In this example, if the generator setting is set to 50% of maximum power, the applicator 10, when activated and receiving energy from the ESU 50, will deliver 11.22 joules per second to the patient tissue, determined by: Y = (26.76) * (0.50) - 2.1561 = 11.22.

[0087] In one embodiment of this disclosure, sensor 64 is configured to sample the output of RF output stage 54 to obtain voltage and current readings. The sampled voltage and / or current is provided to controller 51, which is configured to determine the amount of power output by RF output stage 54 and supplied to applicator 10 based on the sampled voltage and current. Controller 51 can utilize the amount of power supplied to applicator 10 to determine current generator setting X in real time, thereby improving the accuracy of the energy delivered to the patient calculated using Equation 1 above. For example, controller 51 can determine the amount of power delivered to applicator 10 based on actual voltage and current readings that differ from the power setting input to the generator, i.e., the determined power is 55%, while the input power setting is 50%. Controller 51 can use the determined power percentage to more accurately determine the energy delivered to the patient's tissue.

[0088] In another embodiment, controller 51 uses samples from sensor 64 to calculate the amount of power delivered to the patient tissue by applicator 10. For example, samples of the output of stage 54 (e.g., voltage and / or current) and any associated calculations and / or electrical characteristics (e.g., impedance) can be mapped by controller 51 to various temperatures of the sample fluid (in the manner described above in method 100) to determine the energy delivered to the patient tissue based on the calculated power at RF output stage 54. Subsequently, controller 51 is configured to sample the output of stage 54 during surgery, and based on the saved mapping and samples of the output of stage 54, controller 51 is configured to determine the total amount of energy delivered to the patient tissue by applicator 51 during surgery. For example, a lookup table can be programmed into the generator according to the following equation above:

[0089] Y = AZ + B (4)

[0090] Where Y equals the energy delivered per second by the applicator to the patient's tissue, Z is the calculated output power, and A and B are constants determined based on the energy delivery graph constructed in step 114 of method 100. In this example, A = 0.669 and B = -2.1561 (for x >= 4 and <= 40). Controller 51 samples the output stage 54 and determines the power output (Z). In a lookup table, the power output (Z) corresponds to the power (Y) delivered to the patient based on an equation. Knowing Y (J / s) and the total activation time, the generator can determine the total amount of energy delivered to the patient.

[0091] In one embodiment of this disclosure, Equation 1, determined in step 114 and as described above, is stored in the memory 60 of the ESU 50 and executed by the controller 51 during electrosurgery to determine the total amount of energy applied to the patient tissue. In this embodiment, the controller 51 uses at least two pieces of data to calculate or count the energy delivered to the patient tissue: (1) the generator power setting (i.e., X in Equation 1); and (2) the length or duration of the activation time at the power setting. The controller 51 is configured to continuously track the current power setting of the ESU 50 (e.g., using data from sensor 64 and / or tracking user selection received from input / output interface 56) and the activation time at the current power setting to determine or count the energy delivered to the patient tissue. It should be understood that as the applicator 10 is turned on and off to apply plasma to the tissue and to stop applying plasma to the tissue and as the power setting of the ESU 50 changes, the controller 51 continuously uses Equation 1 above to calculate or count the amount of power delivered to the patient tissue.

[0092] In one embodiment, controller 51 may be configured to determine whether the applicator 10 is actually applying energy to patient tissue, rather than to ambient air or another target other than patient tissue. In this embodiment, controller 51 uses samples from sensor 64, such as voltage and current readings or samples, to determine the impedance or impedance change at the output of RF output stage 54. Based on the impedance or impedance change, controller 51 is configured to determine whether energy output by applicator 10 is being applied to patient tissue. For example, controller 51 may determine whether the impedance is at or above a predetermined level or value, and then apply energy to patient tissue. As another example, controller 51 may determine whether the impedance has changed according to a predetermined level or value, and then apply energy to patient tissue. In any case, controller 51 is configured to use Equation 1 to count the energy applied to patient tissue only when controller 51 determines that energy is being applied by applicator 10 to patient tissue and not to the surrounding environment or a target other than patient tissue.

[0093] In one embodiment, the energy delivered to the patient's tissue, calculated by the controller 51, is output by the controller 51 in joules to a display of the ESU 50 via the input / output interface 56, for example, displayed on the touchscreen 21. It should be understood that the input / output section 21 may display the instantaneous energy delivered in joules per second, a cumulative count of the energy delivered in joules, or both. The input / output interface 56 is configured to receive user input (e.g., via one or more buttons 22 of the ESU 50, the touchscreen 21, etc.) to enable the user to set the energy counter of the controller 51 to zero and also to set the energy endpoint.

[0094] refer to Figure 4This illustrates a method 200 for calculating the total amount of energy delivered to patient tissue by applicator 10 according to embodiments of the present disclosure. In step 202, an energy endpoint is set via user input received through input / output interface 56. It should be understood that the energy endpoint can be selected indirectly by selecting a surgical type (e.g., tissue tightening) and / or a surgical type for a specific anatomical location (e.g., skin surface resurfacing of the cheek). Optionally, user input can reset the energy or joule counter to zero before the start of surgery or before treatment of a new anatomical location begins. In step 203, a generator power setting is selected. It should be understood that the generator power setting can be manually selected by the generator operator or can be automatically selected based on the selected surgical type.

[0095] In step 204, the applicator 10 applies plasma energy (or another type of energy) to the patient tissue. In step 206, the controller 51 is configured to monitor and calculate the total amount of energy delivered to the patient tissue by the applicator 10 based on a selected generator power setting. In one embodiment, the cumulative amount of energy delivered to the patient tissue is displayed via the input / output section 21 and continuously updated throughout the process when the applicator 10 is activated. In another embodiment, the input / output section 21 may display the instantaneous energy delivered in joules per second, while also displaying a cumulative count of energy delivered in joules. In step 206, the cumulative amount of delivered energy is compared to an energy endpoint, and if the energy endpoint is reached, the controller 51 notifies the user (e.g., by triggering an audible alarm 58, displaying the total amount of joules delivered on the input / output section 21, triggering a flashing indicator on the ESU 50 display, and / or sending a notification to another device or external device via the communication module) that the energy endpoint has been reached, thereby stopping the application of plasma to the patient. In some embodiments, when the controller 51 determines that the energy endpoint has been reached, the controller 51 automatically causes the energy supply 52 to stop supplying energy to the applicator 10, thereby preventing the supply of additional plasma energy to the patient tissue.

[0096] It should be understood that Equation 1 and Method 200 described above can be used for any type of surgery, electrosurgery, or other procedure in which energy is delivered to the patient's tissue, such as plasma, RF energy, and / or thermal energy via the electrodes of the applicator 10 that are in direct contact with the patient's tissue. Some procedures in which the energy delivered to the patient's tissue can be calculated using Equation 1 and Method 200 may include, but are not limited to, tissue tightening and wrinkle reduction procedures.

[0097] In one embodiment, the controller 51's ability to determine the total amount of energy delivered to the patient's tissue by the applicator 10 is used to determine the optimal amount of energy required for a given procedure performed on a given area of ​​the body. Furthermore, once the optimal energy for various procedures is determined, the energy for each procedure can be stored in the memory 60 of the ESU 50. Once the energy / procedure is stored, the user can select the stored procedure via the input / output section 21, which transmits the selection to the controller 51 via the input / output interface 56. The controller 51 retrieves the corresponding energy required for the selected procedure and uses the energy retrieved from the memory 60 as the energy endpoint to perform the method 200 described above. In this way, the optimal amount of energy is delivered to the patient's tissue each time a given procedure is performed, ensuring consistent results. It should be understood that the generator power setting for the selected procedure can be manually entered by the operator, or the generator power setting can be stored along with the energy endpoint for the given procedure.

[0098] refer to Figure 7 This provides a method 700 for ensuring consistent treatment of different body regions. In step 702, a given or predetermined initial treatment region of the patient is treated by applying electrosurgical energy to the patient's tissue. During this procedure, in step 704, the total amount of energy delivered to the predetermined initial treatment region is determined, for example, in joules, as described above. In step 706, it is determined whether the treatment is complete. If the treatment process is not complete in step 706, the method can return to step 702 and can continue to apply electrosurgical energy to the initial treatment region. Otherwise, if the procedure is complete, the generator or controller 51 can store or record the total amount of energy delivered to the initial treatment region in memory 60 in step 708 to use the total amount of energy delivered as a setpoint or energy endpoint for the contralateral treatment region. In step 710, the patient's contralateral treatment region is treated using the same amount of energy applied to the initial treatment region to ensure consistent (balanced) treatment on both sides of the body.

[0099] As an example, a user can use the applicator 10 and ESU 50 to perform a tissue tightening procedure to reduce skin laxity under each of the patient's arms. To ensure the same treatment is applied to both arms, the user can observe and record the total amount of energy delivered to the patient's right arm, calculated by the controller 51. Alternatively, the controller 51 can store the total amount of energy delivered in the memory 60, which can be associated with the type of surgery / treatment and / or a specific area of ​​the patient, and can be further stored as an energy setpoint for the contralateral area. Then, before performing the tissue tightening procedure on the left arm, the user can set the recorded or stored energy applied to the right arm as an energy endpoint via user input to the input / output interface 56. It should be understood that the user can also select an energy endpoint stored for the contralateral area via the input / output interface 56. In this way, the controller 51 will perform the method 200 described above to ensure that the set energy endpoint is not exceeded and that the same amount of energy applied to the right arm is applied to the left arm. The energy endpoint can be stored in the memory 60 and used in future skin tightening procedures on the arms.

[0100] As another example, a user can perform a skin resurfacing procedure to reduce facial wrinkles using an applicator 10 and an ESU 50. The user can record (by observing calculations by the controller 51) the total amount of energy applied to the right cheek by the applicator 10 during the resurfacing procedure. Alternatively, the controller 51 can store the total amount of energy delivered in a memory 60, where the total amount of energy delivered can be associated with the type of procedure / treatment and / or a specific area of ​​the patient, and can be further stored as an energy setpoint for the contralateral area, i.e., the left cheek. The user can then set the recorded energy as the energy endpoint before performing the resurfacing procedure on the left cheek. It should be understood that the user can also select the energy endpoint stored for the contralateral treatment area (i.e., the left cheek) via an input / output interface 56 (e.g., a touchscreen 21). When performing the skin resurfacing procedure on the left cheek, the controller 51 will execute the method 200 described above to ensure that the set energy endpoint is not exceeded and that the same amount of energy applied to the right cheek is applied to the left cheek. The energy endpoint can be stored in the memory 60 and used for further skin resurfacing procedures.

[0101] As data from various surgeries is collected and stored in memory 60, memory 60 will include data on how much energy is required to perform various surgeries (e.g., skin tightening surgery) on various body areas. This data can be used by controller 51 to prevent overtreatment or undertreatment of body areas. For example, if it is determined that 10J of energy must be applied to a body area (e.g., a quadrant of the abdomen), the user can select the body area via input to input / output interface 56, and the required energy (i.e., 10J) will be retrieved from memory 60 and used by controller 51 as an energy setpoint to ensure that no more than 10J is delivered to the patient's tissues during surgery.

[0102] It should be understood that data for performing various surgeries can be collected in a variety of ways. In one embodiment, data is collected by controller 51 and stored in memory 60 for each surgery performed using ESU 50 and applicator 10. Data accumulated or collected by each ESU 50 can be manually extracted (e.g., by connecting a user to a device such as a Universal Serial Bus (USB) or other type of device and extracting the data) or automatically extracted (e.g., by controller 51 sending or pushing data to an external device, such as a server, via communication module 66) and provided to the server. The server can also collect and store surgical data via a data registry, through which users upload data. The data may come from the results of clinical trials, or from surgeries performed by physicians or other professionals at different institutions. In any case, the data on the server is accessible via communication module 66 for use by each ESU 50 during surgery. Data on the server can be analyzed to determine an optimal dataset smaller than the total dataset on the server. The optimal dataset can be stored in memory 60 and used by controller 51 to perform surgeries based on the data.

[0103] It should be understood that the various features shown and described are interchangeable, that is, features shown in one embodiment can be incorporated into another embodiment.

[0104] Although this disclosure has been shown and described with reference to certain preferred embodiments thereof, those skilled in the art will understand that various changes in form and detail may be made therein without departing from the spirit and scope of this disclosure as defined by the appended claims.

[0105] Furthermore, although the foregoing text has described numerous embodiments in detail, it should be understood that the legal scope of the invention is defined by the words 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. Many alternative embodiments may be implemented using current technology or technology developed after the date of this patent application, which will still fall within the scope of the claims.

[0106] It should also be understood that unless a term is explicitly defined in this patent using the sentence “As used herein, the term '______' is defined herein as…” or a similar sentence, there is no intention to limit the meaning of that term (whether express or implied) beyond its simple or ordinary meaning, and such terms should not be construed as limiting the scope based on any statement made in any part of this patent (other than the language of the claims). To some extent, any term referenced in a claim at the end of this patent is referred to in this patent in a manner consistent with a single meaning, done only for clarity and to avoid confusing the reader, and it is not intended to limit such claim terms to that single meaning by implication or otherwise. Finally, unless a claim element is defined by reference to the word “apparatus” and function, but not to any structure, the scope of any claim element should not be construed as 35 U.S.SC §112, paragraph 6.

Claims

1. An electrosurgical generator, comprising: The power supply unit provides electrosurgical power to the applicator via a radio frequency (RF) output stage; The memory stores at least one energy quantization function that determines the total amount of energy delivered to the patient tissue by the applicator through a predetermined energy delivery device, which is an RF energy delivery device through a plasma arc between the end of the applicator and the patient tissue, an RF energy delivery device through direct contact between the electrodes of the applicator and the patient tissue, or a thermal energy delivery device through direct contact between the heating element of the applicator and the patient tissue. as well as The controller determines the total amount of energy delivered to the patient tissue based on an energy quantization function and the output power of the RF output stage, the output power being determined based on a selected generator power setting; The controller counts the energy delivered to the patient's tissue based on a selected generator power setting and the duration of the activation time of the applicator at the selected generator power setting. The energy quantization function is Y=AX+B, where A and B are constants, Y is the energy delivered to the patient's tissue per second by the applicator, and X is the generator power setting.

2. The electrosurgical generator according to claim 1, wherein the output power is determined by sampling the output voltage and output current of the RF output stage.

3. The electrosurgical generator according to claim 1 further includes an input / output interface, the input / output interface receiving an input for selecting the power setting of the generator.

4. The electrosurgical generator according to claim 1 further includes an input / output interface that displays the total amount of energy delivered to the patient tissue.

5. The electrosurgical generator of claim 4, wherein the total amount of energy delivered to the patient tissue is expressed in joules.

6. The electrosurgical generator of claim 2 further includes at least one sensor coupled to the output of the RF output stage, the sensor being configured to sample the output voltage and / or output current of the RF output stage and provide the sampled output voltage and / or output current to the controller.

7. The electrosurgical generator of claim 6, wherein the selected generator power setting is determined by sampling the output voltage and / or output current of the RF output stage.

8. The electrosurgical generator of claim 1, further comprising at least one sensor that measures the impedance at the RF output stage and provides the measured impedance to the controller, wherein, The controller determines whether the applicator is applying energy to the patient's tissue or to the ambient air based on the measured impedance. The controller adds the delivered energy to the count only when the applicator is applying energy to the patient's tissue and not to the ambient air.

9. The electrosurgical generator of claim 1, further comprising an input / output interface capable of selecting an energy endpoint for surgery, wherein when the count of delivered energy exceeds the energy endpoint, the controller causes the energy supplier to stop supplying electrosurgical energy to the applicator.

10. The electrosurgical generator of claim 9, wherein the controller triggers a notification via the input / output interface when the count exceeds the energy endpoint.

11. The electrosurgical generator of claim 9, wherein the controller triggers a notification when the count exceeds the energy endpoint and sends the notification to an external device via a communication module.

12. The electrosurgical generator of claim 9, wherein the memory stores a predetermined energy endpoint for each of a plurality of surgeries.

13. The electrosurgical generator of claim 12, wherein the input / output interface is capable of selecting at least one of the plurality of surgeries, wherein when at least one surgery is selected, the controller retrieves the corresponding energy endpoint from the memory.

14. The electrosurgical generator of claim 12 further includes a communication module that receives a predetermined energy endpoint for each of a plurality of surgeries from an external device.

15. The electrosurgical generator of claim 1, wherein the at least one energy quantization function is selected based on the type of applicator.

16. The electrosurgical generator of claim 1, wherein the at least one energy quantization function is received from the applicator when the applicator is connected to at least one jack of the electrosurgical generator.

17. The electrosurgical generator of claim 1, further comprising an input / output interface capable of storing in a memory a total count of energy delivered to a first treatment area of ​​the patient as an energy endpoint, wherein when surgery is performed on a contralateral treatment area of ​​the patient, the controller retrieves the stored energy endpoint from the memory.

18. The electrosurgical generator of claim 1, wherein after completing surgery on the first treatment area of ​​the patient, the controller determines the total amount of energy delivered to the patient's tissue and stores the determined total amount of energy in the memory as the energy endpoint of surgery on the contralateral treatment area of ​​the patient.

19. The electrosurgical generator of claim 18, further comprising an input / output interface capable of selecting a procedure for a contralateral treatment region, wherein, when a procedure is selected, the controller retrieves a stored energy endpoint from a memory.

20. The electrosurgical generator of claim 1, further comprising a flow controller for supplying at least one gas to the applicator, wherein the applicator generates plasma from electrosurgical energy and at least one gas, the plasma being delivered to the patient tissue.

21. The electrosurgical generator of claim 20, wherein the controller counts the energy delivered to the patient tissue based on at least one of the type of the at least one gas, the flow rate of the at least one gas, and / or the generator power setting of the electrosurgical setup.

22. The electrosurgical generator of claim 21, further comprising an input / output interface that displays a count of energy delivered to patient tissue, wherein the count of energy delivered to patient tissue is displayed in joules.

23. The electrosurgical generator of claim 21 further includes an input / output interface that displays the total amount of energy delivered to the patient tissue, wherein the total amount of energy delivered to the patient tissue is displayed in joules per second.

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