Apparatus for calculating the amount of energy delivered to tissue during electrosurgical treatment - Patent Application 20070122999

Abstract

The present disclosure relates to an apparatus, system, and method for calculating the amount of energy delivered to tissue during electrosurgical treatment. The present disclosure provides a power source that supplies electrosurgical energy to an applicator via a radio frequency (RF) output stage, a memory that stores at least one energy quantification function that determines the amount of energy delivered to patient tissue by the applicator, and a controller that controls the power source based on a selected power setting and determines the amount of energy delivered to the patient tissue based on the energy quantification function and the selected power setting. The controller counts the energy delivered to the patient tissue based on the selected power setting and the activation time of the applicator at the selected power setting, and displays the delivered energy in joules.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 62 / 945,142, filed December 7, 2019, and entitled "DEVICES, SYSTEMS AND METHODS FOR CALCULATING THE AMOUNT OF ENERGY DELIVERED TO TISSUE DURING AN ELECTROSURGICAL TREATMENT," the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates generally to electrosurgery and electrosurgical systems and devices, and more particularly to devices, systems and methods for calculating the amount of energy delivered to tissue during electrosurgical treatment. [Background technology]

[0003] Radiofrequency electrical energy is widely used in surgery and is commonly referred to as electrosurgical energy, which is used to cut tissue and coagulate body fluids.

[0004] Electrosurgical instruments generally comprise either "monopolar" or "bipolar" devices. Monopolar devices include 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, through the patient's body, and to the return electrode. Such monopolar devices are effective in surgical procedures where cutting and coagulation of tissue are required and stray currents do not pose a substantial risk to the patient.

[0005] Bipolar devices include an active electrode and a return electrode on a surgical instrument. In bipolar electrosurgical devices, electrosurgical energy flows through the active electrode into the patient's tissue and then a short distance through the tissue to the return electrode. The electrosurgical effect is substantially localized to a small area of ​​tissue located between the two electrodes on the surgical instrument. Bipolar electrosurgical devices have proven useful for surgical procedures where stray currents may pose a risk to the patient or other procedural concerns require close proximity between the active and return electrodes. Surgeries involving bipolar electrosurgery often require methods and procedures that are substantially different from those involving monopolar electrosurgery.

[0006] Gas plasma is an ionized gas that can conduct electrical energy. Plasma is used in surgical devices to conduct electrosurgical energy to a patient. The plasma conducts energy by providing a path of relatively low electrical resistance. Electrosurgical energy follows the plasma to cut, coagulate, desiccate, or fulgurate the patient's blood or tissue. No physical contact is required between the electrode and the treated tissue.

[0007] Electrosurgical systems that do not incorporate a regulated gas source can ionize the ambient air between the active electrode and the patient. The plasma thereby generated conducts electrosurgical energy to the patient, but the plasma arc typically appears more spatially dispersed compared to systems with a regulated flow of ionizable gas.

[0008] The amount of energy delivered to patient tissue by an electrosurgical system, for example, by a plasma output by an applicator or handpiece, is not the same as the amount of energy generated and output by the electrosurgical generator of the electrosurgical system. A portion of the energy output by the electrosurgical generator is lost in generating the plasma beam, in addition to other inefficiencies. Knowing the amount of energy delivered to patient tissue, rather than just the amount of energy output by the system's electrosurgical generator, is useful for achieving the desired results in a given treatment. However, currently used electrosurgical systems do not provide a simple and efficient means for accurately measuring the energy delivered to patient tissue. Therefore, there is a need for devices, systems, and methods for calculating the amount of energy delivered to patient tissue. Summary of the Invention [Problem to be solved by the invention]

[0009] The present disclosure relates to devices, systems and methods for calculating the amount of energy delivered to tissue during electrosurgical treatment. [Means for solving the problem]

[0010] According to one aspect of the present disclosure, an electrosurgical generator is provided that includes a power source that supplies electrosurgical energy to an applicator via a radio frequency (RF) output stage, a memory that stores at least one energy quantification function that determines an amount of energy delivered to patient tissue by the applicator, and a controller that determines the amount of energy delivered to patient tissue based on the energy quantification function and the output power of the RF output stage.

[0011] In one aspect, the output power is determined based on a selected generator power setting.

[0012] In another aspect, the output power is determined based on a sampled output voltage and current of the RF output stage.

[0013] In a further aspect, the electrosurgical generator further includes an input / output interface that receives an input for selecting a generator power setting.

[0014] In another aspect, the electrosurgical generator further includes an input / output interface that displays the amount of energy delivered to the patient tissue.

[0015] In one aspect, the amount of energy delivered to the patient tissue is displayed in Joules.

[0016] In a further aspect, the controller counts the energy delivered to the patient tissue based on the selected power setting and the activation time of the applicator at the selected power setting.

[0017] In yet another aspect, the electrosurgical generator further includes at least one sensor coupled to the output of the RF output stage, the sensor configured to sample the voltage and / or current of the RF output stage and provide the sampled voltage and / or current to the controller.

[0018] In yet another embodiment, the selected generator power setting is used to determine the delivered energy based on the sampled voltage and / or current of the RF output stage.

[0019] In one embodiment, the electrosurgical generator further 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.

[0020] In another aspect, the electrosurgical generator further includes an input / output interface that allows for selection of an energy endpoint for the procedure, and the controller causes the generator to cease supplying electrosurgical energy to the applicator when the count exceeds the energy endpoint.

[0021] In one aspect, the controller triggers a notification via the input / output interface when the count exceeds the energy endpoint.

[0022] In another aspect, the controller triggers a notification when the count exceeds the energy endpoint and sends the notification to an external device via the communication module.

[0023] In yet another aspect, the memory stores a predetermined energy endpoint for each of a plurality of treatments.

[0024] In yet another aspect, the input / output interface allows for selection of at least one of a plurality of treatments, and upon selection of the at least one treatment, the controller retrieves a corresponding energy endpoint from the memory.

[0025] In a further aspect, the electrosurgical generator further includes a communications module that receives the predetermined energy endpoints for each of the plurality of procedures from an external device.

[0026] In another embodiment, the at least one energy quantification function is selected based on the type of applicator.

[0027] In one aspect, the at least one energy quantification function is received from the applicator upon coupling the applicator to the at least one receptacle.

[0028] In a further aspect, the electrosurgical generator further includes an input / output interface that enables the total count of energy delivered to a first treatment area of ​​the patient to be stored in memory as an energy endpoint, and upon selection of a procedure for an opposite treatment area of ​​the patient, the controller retrieves the stored energy endpoint from memory.

[0029] In one aspect, upon completion of treatment for a first treatment area on the patient, the controller determines the total amount of energy delivered to the patient tissue and stores the determined total amount of energy in memory as an energy endpoint for treatment for an opposite treatment area on the patient.

[0030] In another aspect, the electrosurgical generator further includes an input / output interface that allows selection of a treatment for the contralateral treatment area, and upon treatment selection, the controller retrieves a stored energy endpoint from memory.

[0031] According to one aspect of the present disclosure, the electrosurgical generator further includes a flow controller that provides at least one gas to the applicator, the applicator generating a plasma from the electrosurgical energy and the at least one gas, and the plasma being delivered to the patient tissue.

[0032] In one embodiment, the controller counts the energy delivered to the patient tissue based on at least one of the type of at least one gas, the flow rate of the at least one gas, and / or the power setting of the electrosurgical setting.

[0033] In another aspect, the electrosurgical generator further includes an input / output interface that displays a count of the amount of energy delivered to the patient tissue, the count being displayed in joules.

[0034] In a further aspect, the electrosurgical generator further includes an input / output interface that displays the amount of energy delivered to the patient tissue, the amount of energy delivered to the patient tissue being displayed in joules per second.

[0035] According to another aspect of the present disclosure, there is provided a method of performing a medical procedure comprising applying electrosurgical energy to patient tissue via an electrosurgical generator; determining an amount of energy delivered to the patient tissue based on at least one energy quantification function and an output of the electrosurgical generator; comparing the determined amount of delivered energy to an energy endpoint; and terminating the application of the electrosurgical energy if the determined amount of delivered energy meets or exceeds the energy endpoint.

[0036] In one aspect, the method further includes displaying the amount of energy delivered to the patient tissue via an input / output interface of the electrosurgical generator.

[0037] In another embodiment, the amount of delivered energy displayed is the instantaneous energy being delivered in Joules / second.

[0038] In a further aspect, the amount of delivered energy displayed is a cumulative count of the delivered energy in joules.

[0039] In yet another aspect, the method further includes triggering a notification when the amount of energy delivered meets or exceeds an energy endpoint.

[0040] In one aspect, the method further includes storing in a memory the predetermined energy endpoint for each of the plurality of treatments.

[0041] In yet another aspect, the method further includes selecting at least one treatment and retrieving a corresponding energy endpoint from memory.

[0042] In a further aspect, the applying step further includes providing electrosurgical energy to the patient tissue via an applicator coupled to the electrosurgical generator, providing at least one gas to the applicator, and generating a plasma from the electrosurgical energy and the at least one gas that is delivered to the patient tissue.

[0043] In one embodiment, the at least one energy quantification function is based on at least one of the type of applicator, the type of at least one gas, and / or the flow rate of the at least one gas.

[0044] In another aspect, the method further includes determining a total amount of energy delivered to the patient tissue upon completion of treatment for a first treatment area on the patient, and storing the determined total amount of energy in memory as an energy endpoint for treatment for an opposite treatment area on the patient.

[0045] In yet another aspect, the method further includes selecting a treatment for the contralateral treatment region and retrieving the stored energy endpoint from memory. [Brief explanation of the drawings]

[0046] The above and other aspects, features, and advantages of the present disclosure will become more apparent in light of the following detailed description taken in conjunction with the accompanying drawings.

[0047] [Figure 1] 1 is a diagram of an electrosurgical system according to one embodiment of the present disclosure; [Figure 2A] FIG. 2 is a front view of an electrosurgical generator of the electrosurgical system of FIG. 1 according to one embodiment of the present disclosure. [Figure 2B] FIG. 2 is a block diagram of an electrosurgical generator of the electrosurgical system of FIG. 1 according to one embodiment of the present disclosure. [Figure 3]10 is a flowchart illustrating a method for determining a formula for calculating the amount of energy delivered to patient tissue by an applicator of the electrosurgical system of FIG. 1 according to one embodiment of the present disclosure. [Figure 4] 10 is a flowchart illustrating a method for counting the amount of energy delivered to patient tissue by an applicator of the electrosurgical system of FIG. 1 according to one embodiment of the present disclosure. [Figure 5] 10A-10C illustrate exemplary results of a method for determining a formula for calculating the amount of energy delivered to patient tissue by an applicator of an electrosurgical system, according to one embodiment of the present disclosure; [Figure 6] 1 is a graph used to determine a Joule counter equation according to one embodiment of the present disclosure. [Figure 7] 10 is a flowchart illustrating a method for applying electrosurgical energy to different portions of a patient using an electrosurgical system, according to one embodiment of the present disclosure;

[0048] It should be understood that the drawings are for purposes of illustrating the concepts of the disclosure and are not necessarily the only possible configuration for illustrating the disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0049] Preferred embodiments of the present disclosure will now be described with reference to the accompanying drawings. In the following description, well-known functions or structures will not be described in detail to avoid obscuring the present disclosure in unnecessary detail. In the drawings and the following description, as is conventional, the term "proximal" refers to the end of a device, such as an instrument, device, applicator, handpiece, forceps, etc., that is closer to the user, while the term "distal" refers to the end that is farther from the user. As used herein, the term "coupled" is defined to mean directly connected or indirectly connected via one or more intermediate components. Such intermediate components may include both hardware-based and software-based components.

[0050] Those skilled in the art will appreciate that the block diagrams presented herein represent conceptual views of illustrative circuitry embodying the principles of the present disclosure. Similarly, it will be appreciated that any flowcharts, flow diagrams, state transition diagrams, pseudocode, or the like, may be substantially represented on a computer-readable medium and represent various processes that may be executed by a computer or processor, whether or not such a computer or processor is explicitly shown.

[0051] The present disclosure relates to devices, systems and methods for calculating the amount of energy delivered to tissue during electrosurgical treatment.

[0052] 1, an electrosurgical system 1 according to the present disclosure is shown. System 1 includes an applicator or handpiece 10 and an electrosurgical generator unit (ESU) 50. In some embodiments, system 1 further includes a gas supply 70.

[0053] The applicator 10 is configured to receive electrosurgical energy from the ESU 50 via the cable 20. The applicator 10 is further configured to receive inert gas from a gas source 70. In some embodiments, the inert gas is received from the gas source 70 and provided to the applicator 10 from the ESU 50 via the cable 20. It should be understood that the gas source 70 may be internal to the ESU 50 or external to the ESU 50. In other embodiments, the applicator 10 receives the inert gas directly from the gas source 70. The applicator 10 includes a handle housing 12 having a button 18 and a shaft 14 having a distal tip 16. When the button 18 is pressed, electrosurgical energy is delivered to the applicator 10 by the ESU 50 and inert gas is delivered to the applicator 10 by the gas source 70. The electrosurgical energy is used to energize an electrode disposed within the shaft 14. As the inert gas passes over the energized electrode, a plasma is generated and emitted from the tip 16 into the patient tissue, allowing for the conduction of radio frequency (RF) energy from the electrode to the patient in the form of a precise plasma beam. In one embodiment, helium is used as the inert gas because it can be converted to plasma with very little energy, although other inert gases, such as argon, are also considered within the scope of this disclosure. Additionally, mixtures of inert gases may be utilized to generate the plasma. An exemplary applicator is shown and described in commonly owned U.S. Patent No. 9,060,765, the contents of which are incorporated by reference.

[0054] It should be understood that in some embodiments, the applicator 10 may be configured to apply or deliver energy to patient tissue in ways or forms other than plasma. For example, the applicator 10 may deliver RF energy to patient tissue by directly contacting an electrode with the patient tissue. In some embodiments, the electrode is retractable within the shaft 14, allowing the electrode to be extended and used to deliver RF energy in direct contact with the patient tissue, or retracted and to deliver RF energy via plasma. In other embodiments, the electrode may be configured as a probe or heating element (e.g., heated by applying current received from the ESU 50 to the heating element), and thermal energy may be applied directly to the patient tissue by the heating element.

[0055] Referring to FIG. 2A, a front view of an ESU 50 according to one embodiment of the present disclosure is shown. In one embodiment, the ESU 50 includes a high-frequency electrosurgical generator 61 and a gas flow controller 62 housed within a single housing 63. The ESU 50 includes a front panel face 19 including an input / output section 21, such as a touchscreen, for entering commands and data into the ESU 50 and displaying data. The front panel 19 may further include various level controls 22 with corresponding indicators 24. Additionally, the ESU 50 includes a receptacle section 26 that may include an on / off switch 28, a return electrode receptacle 30, a monopolar foot switching receptacle 32, a monopolar hand switching receptacle 34, and a bipolar hand switching receptacle 36. The gas flow controller 62 includes a gas receptacle portion 38 that may further include a gas A inlet receptacle 40 and a gas B inlet receptacle 42. Gas flow controller 62 may further include a user interface portion 44 including a selector switch or input portion 46 and a display 48. Selector switch or input portion 46 allows for selection of the type of gas to be insufflated, selection of the mixture of gases to be insufflated, the composition and / or percentage of the mixture of gases to be insufflated, the flow rate of gas applied to the handpiece or applicator, etc. While FIG. 2A shows high frequency electrosurgical generator 61 and gas flow controller 62 contained within a single housing 63, it should be understood that gas flow controller 62 may be provided as a separate external device that interfaces with ESU 50 via a wired and / or wireless interface.

[0056] 2B, a block diagram of an ESU 50 is shown in accordance with one embodiment of the present disclosure. ESU 50 includes a controller or processor 51, a power supply 52, a radio frequency (RF) output stage 54, an I / O interface 56, an alarm 58, a memory 60, a flow controller 62, a sensor 64, and a communications module 66. Controller 51 is configured to control power supply 52 to supply electrosurgical energy output from RF output stage 54 to applicator 10 via at least one conductor extending through cable 20. It should be understood that cable 20 may be coupled to ESU 50 via monopolar hand switching receptacle 34 or bipolar hand switching receptacle 36. I / O interface 56 is configured to receive user input provided to controller 51 (e.g., via one or more buttons 22, 46 located on the housing of ESU 50, touchscreen 21, etc.) and output information received from controller 51 (e.g., data to indicators 24, a graphical user interface to touchscreen 21, etc.). Audible alarms 58 are controllable via controller 51 to alert the operator to various conditions or events.

[0057] Flow controller 62 is configured to control the flow of gas received by applicator 10 from source 70. Flow controller 62 is coupled to controller 51 and receives control signals from controller 51 based on user input via I / O interface 56, selector switch or input 46, or based on algorithms or software functions stored in memory 60. Additionally, flow controller 62 may include appropriate sensors to determine the type of gas being injected into receptacles 40, 42. Furthermore, flow controller 62 may use the injected gas to generate a mixture of gases provided to the applicator. While flow controller 62 is located within ESU 50 in the embodiment shown in FIG. 2B, flow controller 62 may also be located external to ESU 50, such as in a separate housing, within applicator 10, etc.

[0058] The communications module 66 of the ESU 50 is configured to communicate with other devices (e.g., client devices, servers, etc.) via a communications link (e.g., wired or wireless) to send and receive data and communications. In the embodiment shown in FIG. 2B , the operator is alerted to various conditions via the audible alarm 58, but in other embodiments, the controller 51 may use the communications module 66 to send notifications to at least one other device via a communications link (e.g., wired or wireless), with the communications associated with various conditions or events. The communications module 66 may be a modem, a network interface card (NIC), a wireless transceiver, etc. The communications module 66 performs its functions via hardwired and / or wireless connections. Hardwired connections may include, but are not limited to, hardwired cables, such as parallel or serial cables, RS232, RS485, USB cables, Firewire (1394 connections), Ethernet, and suitable communications port configurations located on the surface of the housing 63. The wireless connection may operate under any of a variety of wireless protocols, including, but not limited to, Bluetooth™ interconnectivity, infrared connectivity, wireless transmission connectivity including computer digital signal broadcasting and reception commonly referred to as Wi-Fi or 802.11.X (where x represents the type of transmission), satellite transmission or any other type of communication protocol, any currently existing or later developed communication architecture or system for wirelessly transmitting data including spread spectrum at 900 MHz or other frequencies, Zigbee, and / or any mesh-enabled wireless communication.

[0059] 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 output stage 54 and provide the sampled voltage and / or current to controller 51. Controller 51 can use the information to determine one or more characteristics related to the power provided 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 to a digital signal input to controller 51, or alternatively, at least one analog-to-digital converter may be provided in controller 51.

[0060] In one embodiment, the controller 51 is configured to determine the amount of energy, e.g., in joules, delivered by the applicator 10 to the patient tissue during treatment. The controller 51 executes an energy quantification algorithm or function (e.g., stored in the memory 60 of the ESU 50) that enables the controller 51 of the ESU 50 to determine the amount of energy delivered by the applicator 10 to the patient tissue over a period of time. The algorithm or function utilizes a formula or look-up table for determining the energy delivered to the tissue. As described below, in one embodiment, the formula is based on the results of calorimeter testing.

[0061] It should be understood that the functionality of ESU 50 illustrated in FIGS. 1 and 2A-2B may be provided using dedicated hardware and hardware capable of executing software in association with appropriate software. In one embodiment, some or all of the functionality of controller 51 may be performed by at least one processor, such as a computer or electronic data processor, digital signal processor or embedded microcontroller, field programmable gate array (FPGA), or the like, in accordance with code, such as computer program code, software, firmware, register transfer logic, and / or integrated circuits, coded to perform such functionality, unless otherwise indicated. If provided by a processor, the functionality may be provided by a single dedicated processor, a single shared processor, or multiple individual processors, some of which may be shared. Furthermore, explicit use of the terms “processor” or “controller” should not be construed to refer exclusively to hardware capable of executing software and can implicitly include, without limitation, digital signal processor (DSP) hardware, read-only memory (ROM), random access memory (RAM), and non-volatile storage for storing software and / or firmware.

[0062] Referring to FIG. 3, a method 100 for determining a formula for calculating the amount of energy delivered to patient tissue by the applicator 10 is shown, according to one embodiment of the present disclosure.

[0063] In step 102, a predetermined fluid volume (e.g., saline) is placed into the 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, e.g., via the touchscreen 21 or appropriate level control 22, and the applicator 10 is used to apply plasma energy (or other types of energy, e.g., RF energy via direct electrode contact with the fluid volume, thermal energy via direct electrode or heating element contact with the fluid volume, etc.) to the fluid volume for a predetermined duration or length of time. It should be understood that as long as the distal tip 16 is held within a sufficient distance from the surface of the fluid volume (or patient tissue) to generate a plasma arc between the distal tip 16 and the fluid surface (or patient tissue), the tip 16 can be held any distance within this sufficient distance without delivering more heat to the fluid (or patient tissue). Thus, once within a sufficient distance, the tip 16 can be placed closer or farther from the fluid surface or patient tissue without changing the amount of heat delivered. It should be understood that the generator setting of the ESU 50 represents the amount of power delivered by the ESU 50 (e.g., from the RF output stage 54) to the applicator 10. In one embodiment, the power setting is expressed as a percentage of the maximum power deliverable by the ESU 50 to the applicator 10. For example, in one embodiment, the maximum output power deliverable from the ESU 50 to the applicator 10 may be 40 watts (W). Thus, setting the ESU 50 to 20% results in an output of 20% of 40 W (i.e., 8 W).

[0064] In step 108, a calorimeter is used to measure the temperature of the fluid volume after applying plasma energy for a predetermined period of time. In step 110, the amount of energy delivered to the fluid volume by applicator 10 is calculated by calculating the amount of energy required to raise the temperature of the known fluid volume over a predetermined period of time from the baseline temperature measured in step 104 to the temperature measured in step 108. The data from steps 104-110 is recorded in an energy delivery chart or table (e.g., stored in a memory, such as memory 60). In one embodiment, the temperature measured in step 108 is input to ESU 50, for example, via input / output unit 21. The amount of energy required to raise the temperature of the known fluid volume 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 manner, an energy delivery chart or table can be generated by controller 51 and stored in memory 60 for later use.

[0065] In step 112, a new generator setting (e.g., in one embodiment, increasing the percentage of delivered power by a predetermined incremental amount) is selected via input / output section 21 or appropriate level control section 22, and steps 104 through 112 are performed until the maximum power setting of ESU 50 is reached. In this manner, an energy delivery chart includes the amount of energy being delivered over a predetermined period of time across a number of different generator settings of ESU 50. In step 114, an energy delivery (or joule counter) chart is generated based on the data collected in steps 104 through 112, and a formula, e.g., an energy quantification function, for calculating the amount of energy delivered to patient tissue by applicator 10 is determined based at least in part on the energy delivery chart, the details of which are described in more detail below in connection with FIGS. 5 and 6.

[0066] It should be understood that method 100 can be used to determine an equation, e.g., an energy quantification function, for calculating the amount of energy delivered to patient tissue via any energy delivery means (e.g., RF energy delivery via a plasma arc between tip 16 and fluid or patient tissue, RF energy delivery via direct contact between an electrode of applicator 10 and fluid or patient tissue, thermal energy delivery via direct contact between a heating element of applicator 10 and fluid or patient tissue).

[0067] In one embodiment, the equation determined in step 114 is: Y = AX + B (Equation 1) (when x ≥ 10 and ≤ 100) (1)

[0068] In Equation 1 above, Y equals the energy per second delivered to the patient tissue by the applicator 10, X is the generator power setting (e.g., a percentage of the maximum power deliverable 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 the constants A and B vary depending on the electrical characteristics of the ESU 50 and the applicator 10. Thus, if the ESU 50 is used with applicators 10 having different electrical characteristics, the memory 60 of the ESU 50 may store different values ​​of the constants A and B associated with each different applicator 10 that may be used with the ESU 50. Alternatively, the connector of each applicator may include a memory that stores the constants A and B and transfers the constants to the controller 51 when an application is coupled to the ESU 50.

[0069] Exemplary results of the method of Figure 3 are shown in Figures 5 and 6. The results of steps 104 through 112 of method 100 are shown in Figure 5. For each generator power setting 302, the measured change in temperature (ΔT) 304 of the fluid, such as saline, is recorded. The energy delivered to raise the saline temperature 306 is then calculated for each generator power setting 302 using the following equation: Es=ΔT×H×D×V (2) where ΔT is the measured temperature change 304, H is the heat capacity of the saline (J / kg K) = 4150, D is the density of the saline (kg / L) = 1.0046, and V is the volume of the saline (mL) = 30. The calculated energy delivered to raise the saline temperature (ES) 306 is then used to calculate the energy per second 308 delivered to the patient tissue using the following equation: Ep=Es / Startup time (3) Here, the start-up time is 40 seconds. Data for the energy delivered to the patient tissue, Ep 308, is then plotted for each generator power setting 302 used, as shown in FIG. 6. A 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 the data shown in FIG. 5, A = 26.76, B = -2.1561. Using Equation 1 with the determined constants A and B, the energy delivered to the tissue, Ep 308, can be determined for a given generator power setting, X.

[0070] It should be understood that other variables or factors may be considered when determining the energy quantification functions or energy delivery charts of the present disclosure. In one embodiment, method 300 may be performed using various types of inert gases, and then an energy quantification function may be generated and stored for each type of gas. In another embodiment, method 300 may be performed using various mixtures of gases, and then an energy quantification function may be generated and stored for each mixture of gases. 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 quantification function or energy delivery table. It should be understood that the density of the gas mixture may be selected via input 21, selector input 46, or may be determined automatically by ESU 50, for example, by flow controller 62 incorporating an appropriate sensor. In another embodiment, method 300 may be performed using various flow rates for a given gas, and then an energy quantification function may be generated and stored for each flow rate of the given gas. It should be understood that a single variable or various combinations of variables may be used to generate and select an appropriate energy quantification function or energy delivery table. For example, selecting a gas type and flow rate can cause the controller 51 to select a corresponding energy quantification function or energy delivery table. In another example, selecting a gas mixture and flow rate can cause the controller 51 to select a corresponding energy quantification function or energy delivery table.

[0071] In one embodiment, the controller or processor 51 of the ESU 50 is configured to determine the type of applicator 10 coupled to the ESU 50 (e.g., based on user input received via interface 56 or automatically by communicating with the memory or processor of the applicator 10) and use the 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, while activated and receiving power from the ESU 50, will deliver 11.22 joules per second to the patient tissue, as determined as Y=(26.76)×(0.50)−2.1561=11.22.

[0072] In one embodiment of the present disclosure, sensor 64 is configured to sample the output of RF output stage 54 for voltage and current readings. The sampled voltage and / or current are provided to controller 51, which is configured to determine the amount of power output by RF output stage 54 and provided to applicator 10 based on the sampled voltage and current. The amount of power provided to applicator 10 can be used by controller 51 to determine the current generator setting X in real time to improve the accuracy of calculations using Equation 1 above of the energy delivered to the patient. For example, controller 51 can determine, based on the actual voltage and current readings, that the amount of power being delivered to applicator 10 is different from the power setting input to the generator, i.e., the determined power is 55% and the input power setting is 50%. Controller 51 can use the determined power percentage to more accurately determine the energy delivered to patient tissue.

[0073] In another embodiment, sampling from sensor 64 is used by controller 51 to calculate the amount of power delivered to patient tissue by applicator 10. For example, sampling of the output of stage 54 (e.g., voltage and / or current) and any associated calculations and / or electrical properties (e.g., impedance) can be mapped by controller 51 to various temperatures of the sample fluid (as described above with respect to method 100) to determine the energy delivered to the patient tissue based on the calculated power at RF output stage 54. Controller 51 is then configured to sample the output of stage 54 during treatment, and based on the stored mapping and sampling of the output of stage 54, controller 51 is configured to determine the amount of energy delivered to patient tissue by applicator 51 during treatment. For example, a lookup table can be programmed into the generator based on the following equation, as described above: Y=AZ+B (4) where Y equals the energy per second delivered to the patient tissue by the applicator 10, Z is the calculated output power, and A and B are constants determined based on the energy delivery chart constructed in step 114 of method 100. In this example, A=0.669 and B=-2.1561 (for x≧4 and ≦40). The controller 51 samples the output stage 54 and determines the power output (Z). In the lookup table, the power output (Z) corresponds to the power being delivered to the patient (Y) based on the formula: By knowing Y (J / s) and the amount of activation time, the generator can determine the amount of energy delivered to the patient.

[0074] In one embodiment of the present disclosure, Equation 1 determined in step 114 and described above is stored in the memory 60 of the ESU 50 and executed by the controller 51 during an electrosurgical procedure to determine the amount of energy applied to the patient tissue. In this embodiment, the controller 51 calculates or counts the energy delivered to the patient tissue using at least two pieces of data: (1) the generator power setting (i.e., X in Equation 1) and (2) the length or duration of activation time at that power setting. The controller 51 is configured to continuously track the current power setting of the ESU 50 (e.g., using data from the sensor 64 and / or tracking a user selection received from the I / O interface 56) and the activation time at the current power setting to determine or count the amount of energy delivered to the patient tissue. It should be understood that when the applicator 10 is turned on to apply plasma to tissue or turned off to discontinue application of plasma to tissue, or when the power setting of the ESU 50 is changed, the controller 51 is continuously calculating or counting the amount of power delivered to the patient tissue using Equation 1 described above.

[0075] In one embodiment, the controller 51 can be configured to determine whether the applicator 10 is actually applying energy to patient tissue and not to the ambient air or another target other than patient tissue. In this embodiment, the controller 51 uses sampling, e.g., voltage and current readings or samples, from the sensor 64 to determine the impedance or change in impedance at the output of the RF output stage 54. Based on the impedance or change in impedance, the controller 51 is configured to determine whether the energy output by the applicator 10 is being applied to the patient tissue. For example, the controller 51 may determine that energy is being applied to the patient tissue if the impedance is equal to or greater than a predetermined level or value. As another example, the controller 51 may determine that energy is being applied to the patient tissue if the impedance changes by a predetermined level or value. In either case, the controller 51 is configured to count the energy applied to the patient tissue using only Equation 1, and the controller 51 determines that energy is being applied by the applicator 10 to the patient tissue and not to the ambient air or another target other than the patient tissue.

[0076] In one embodiment, the energy delivered to the patient tissue as calculated by the controller 51 is output by the controller 51 in Joules to a display of the ESU 50 via the I / O interface 56, such as displayed on the touchscreen 21. It should be understood that the input / output 21 may display the instantaneous energy being delivered in Joules / second, a cumulative count of the delivered energy in Joules, or both simultaneously. The I / O interface 56 is configured to receive user input (e.g., via one or more buttons 22, the touchscreen 21, etc. of the ESU 50) to allow the user to set the energy counter of the controller 51 to zero and to set an energy endpoint.

[0077] Referring to FIG. 4, a method 200 for counting the amount of energy delivered to patient tissue by the applicator 10 is shown, according to one embodiment of the present disclosure. In step 202, an energy endpoint is set via user input received by the I / O interface 56. It should be understood that the energy endpoint may be selected indirectly by selecting a treatment type, e.g., tissue tightening, and / or a treatment type for a particular anatomical location, e.g., cheek skin resurfacing. Optionally, the user input may reset the energy or joule counter to 0 before the treatment begins or before beginning treatment of a new anatomical location. In step 203, a generator power setting is selected. It should be understood that the generator power setting may be selected manually by the generator operator or automatically based on the selected type of treatment.

[0078] In step 204, the applicator 10 is used to apply plasma (or another type of) energy to the patient tissue. In step 206, the controller 51 is configured to monitor and calculate the amount of energy delivered to the patient tissue by the applicator 10 based on the selected generator power setting. In one embodiment, the cumulative amount of energy delivered to the patient tissue is displayed via the input / output 21 and is constantly updated throughout the treatment while the applicator 10 is active. In another embodiment, the input / output 21 may display the instantaneous energy being delivered in Joules / second, as well as a cumulative count of the energy delivered in Joules. In step 206, the cumulative amount of energy delivered is compared to the energy endpoint, and if the energy endpoint is reached, the controller 51 notifies the user that the energy endpoint has been reached (e.g., by triggering an audible alarm 58, by displaying the total amount of joules delivered on the input / output 21, by triggering a flashing indicator on the display of the ESU 50, and / or by sending a notification to another or external device via the communications module), so that the user can stop applying plasma to the patient tissue. In some embodiments, once the controller 51 determines that the energy endpoint has been reached, the controller 51 automatically causes the power source 52 to stop supplying power to the applicator 10 so that additional plasma energy cannot be provided to the patient tissue.

[0079] It should be understood that Equation 1 and method 200 described above can be used in electrosurgical or any other type of treatment, where the energy is delivered to the patient tissue via, for example, a plasma, RF energy via direct contact between the electrodes of applicator 10 and the patient tissue, and / or thermal energy via direct contact between the heating elements of applicator 10 and the patient tissue. Some treatments for which Equation 1 and method 200 can be used to calculate the energy delivered to the patient tissue can include, but are not limited to, tissue tightening and wrinkle reduction treatments.

[0080] In one embodiment, the controller 51's ability to determine the amount of energy delivered to patient tissue by the applicator 10 is used to determine the optimal amount of applied energy that needs to be applied for a given treatment performed on a given area of ​​a body part. Furthermore, once the optimal energies for various treatments have been determined, the energy for each treatment can be stored in the memory 60 of the ESU 50. Once the energies / treatments are stored, the user can select a stored treatment via the I / O section 21, which transmits the selection to the controller 51 via the I / O interface 56. The controller 51 then retrieves the corresponding energy required for the selected treatment and performs the method 200 described above using the retrieved energy from the memory 60 as the energy endpoint. In this manner, the optimal amount of energy is delivered to the patient tissue each time a given treatment is performed, thus ensuring consistent results. It should be understood that the generator power setting for a selected treatment may be manually entered by the operator, or alternatively, the generator power setting may be stored along with the energy endpoint for a given treatment.

[0081] Referring to FIG. 7, a method 700 for ensuring consistent treatment of different body regions is provided. In step 702, a given or predetermined initial treatment region of a patient is treated by applying electrosurgical energy to the patient's tissue. During the treatment, the amount of energy, e.g., in joules, delivered to the predetermined initial treatment region is determined in step 704, as described above. In step 706, it is determined whether the treatment is complete. If the treatment treatment is not complete in step 706, the method may return to step 702, and electrosurgical energy may continue to be applied to the initial treatment region. Otherwise, if the treatment is complete, the generator or controller 51 may store or record in memory 60 the amount of energy delivered to the initial treatment region in step 708, for use as a set point or energy endpoint for the contralateral treatment region. In step 710, the contralateral treatment region of the patient 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.

[0082] As an example, a user may 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 uniform treatment of both arms, the user may observe the amount of energy delivered to the patient's right arm as calculated by the controller 51 and record the delivered energy. Alternatively, the controller 51 may store the delivered amount of energy in memory 60, which may be associated with a type of procedure / treatment and / or a particular region of the patient and further stored as an energy set point for the contralateral region. The user may then set the recorded or stored energy applied to the right arm as an energy endpoint via user input to the I / O interface 56 before performing the tissue tightening procedure on the left arm. It should be understood that the user may also select a stored energy endpoint for the contralateral region via the I / O interface 56. In this manner, the controller 51 executes the method 200 described above to ensure that the same amount of energy is applied to the left arm as was applied to the right arm without exceeding the set energy endpoint. The energy endpoint may be stored in memory 60 and used in future arm skin tightening procedures.

[0083] As another example, a user may perform a skin resurfacing procedure using the applicator 10 and the ESU 50 to reduce facial wrinkles. The user may record the amount of energy applied by the applicator 10 to the right cheek during the resurfacing procedure (by observing the calculations of the controller 51). Alternatively, the controller 51 may store the delivered amount of energy in the memory 60, which may be associated with the type of treatment and / or a specific area of ​​the patient and further stored as an energy set point for the opposite area, i.e., the left cheek. The user may then set the recorded energy as an energy endpoint before performing the resurfacing procedure on the left cheek. It should be understood that the user may also select the stored energy endpoint for the opposite treatment area, i.e., the left cheek, via the I / O interface 56, e.g., the touchscreen 21. When the skin resurfacing procedure is performed on the left cheek, the controller 51 executes the method 200 described above to ensure that the same amount of energy is applied to the left cheek as was applied to the right cheek without exceeding the set energy endpoint. The energy endpoints may be stored in memory 60 and used in future skin resurfacing procedures.

[0084] As data from various treatments is collected and stored in memory 60, memory 60 will contain data regarding the amount of energy required to perform various treatments (e.g., skin tightening treatments) in various body regions. This data can be used by controller 51 to prevent over- or under-treatment of a body region. For example, if it is determined that 10 J of energy should be applied to one region of the body (e.g., the abdominal quadrant), the user can select the body region via input to I / O interface 56, and the required energy (i.e., 10 J) will be retrieved from memory 60 and used by controller 51 as an energy set point to ensure that no more than 10 J is delivered to the patient tissue during the treatment.

[0085] It should be understood that data for performing various procedures may be collected in several ways. In one embodiment, data is collected by the controller 51 for each procedure performed using the ESU 50 and applicator 10 and stored in memory 60. The data accumulated or collected by each ESU 50 may be extracted and provided to a server either manually (e.g., by a user connecting a device, such as a universal serial bus (USB) or other type of device, and extracting the data) or automatically (e.g., when the controller 51 sends or pushes the data to an external device, such as a server, via the communications module 66). Data for a procedure may also be collected and stored by the server via a data registry where a user uploads data to the server. The data may be generated from clinical trial findings, or the data may be generated from procedures performed by physicians or other professionals at various facilities. In either case, the data on the server may be accessible for use by each ESU 50 via the communications module 66 used in the procedure. The data on the server may be analyzed to determine an optimal data set that is smaller than the total data set on the server. The optimal data set may be stored in memory 60 and used by the controller 51 to perform the procedure according to the data.

[0086] It should be understood that the various features shown and described are interchangeable, i.e., features shown in one embodiment can be incorporated into another embodiment.

[0087] While the present disclosure has been shown and described with reference to certain preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and details can be made therein without departing from the spirit and scope of the present disclosure as defined by the appended claims.

[0088] Furthermore, while the above text sets forth detailed descriptions of numerous embodiments, it should be understood that the legal scope of the present invention is defined by the language of the claims at the end of this patent. Because it is impractical, if not impossible, to describe every possible embodiment, the detailed description should be construed as exemplary only and does not describe every possible embodiment. Numerous alternative embodiments can be implemented, using either current technology or technology developed after the filing date of this patent, and still fall within the scope of the claims.

[0089] It should also be understood that unless a term in this patent is expressly defined using the sentence "As used herein, the term '______' is hereby defined to mean . . . " or a similar sentence, no intention is made to limit the meaning of the term beyond its plain or ordinary meaning, whether express or implied, and such term should not be construed as limited in scope based on any statement made in any section of this patent (other than the language of the claims). To the extent that any term recited in the final claims of this patent is referred to in this patent in a manner consistent with a single meaning, that reference is made solely for clarity to avoid confusing the reader and is not intended to limit, by implication or otherwise, such claim term to that single meaning. Finally, unless a claim element is defined by reciting the word "means" and a function without reciting any structure, the scope of the claim element is not intended to be construed under application of 35 U.S.C. § 112, paragraph 6.

Claims

1. a power supply that supplies electrosurgical energy to the applicator via a radio frequency (RF) output stage; a memory storing at least one energy quantification function for determining an amount of energy delivered by said applicator to patient tissue via a given energy delivery means; a controller that determines the amount of energy delivered to the patient tissue based on the energy quantification function and at least one parameter of the RF output stage; the energy delivery means is a means for delivering RF energy via a plasma arc between the tip of the applicator and the patient tissue, or a means for delivering RF energy via direct contact between an electrode of the applicator and the patient tissue, or a means for delivering thermal energy via direct contact between a heating element of the applicator and the patient tissue; the at least one energy quantification function determines actual energy delivered to the surface of the patient tissue, excluding energy at the energy delivery means, based on at least one parameter of the RF output stage; the at least one parameter is determined based on a selected generator power setting; the controller counts the amount of energy delivered to the patient tissue based on the selected generator power setting and the activation time of the applicator at the selected generator power setting; the energy quantification function is Y=AX+B, where A and B are constants, Y is the energy per second delivered to the patient tissue by the applicator, and X is the generator power setting; Electrosurgical generator.

2. the at least one parameter is an output power of the RF output stage, the output power being determined from sampled output voltages and output currents of the RF output stage; 10. An electrosurgical generator according to claim 1.

3. an input / output interface for receiving an input for selecting the generator power setting; 10. An electrosurgical generator according to claim 1.

4. and an input / output interface that displays the amount of energy delivered to the patient tissue.

10. An electrosurgical generator according to claim 1.

5. the amount of energy delivered to the patient tissue is displayed in joules; 5. An electrosurgical generator according to claim 4.

6. further comprising at least one sensor coupled to an output of the RF output stage; the sensor is configured to sample an output voltage and / or an output current at the RF output stage and provide the sampled output voltage and / or output current to the controller.

3. An electrosurgical generator according to claim 2.

7. the selected generator power setting is determined from the sampled output voltage and / or output current of the RF output stage.

7. An electrosurgical generator according to claim 6.

8. and at least one sensor that measures an impedance at the RF output stage and provides the measured impedance to the controller. the controller determines whether the applicator is applying energy to the patient tissue or to ambient air based on the measured impedance, and adds to the count the amount of energy delivered to the patient tissue only when the applicator is applying energy to the patient tissue, but not when the applicator is applying energy to the ambient air.

10. An electrosurgical generator according to claim 1.

9. further comprising an input / output interface that allows selection of an end point for the energy dose for treatment; the controller causes the generator to cease supplying electrosurgical energy to the applicator when the count exceeds the energy dose endpoint.

10. An electrosurgical generator according to claim 1.

10. the controller triggers a notification via the input / output interface when the count exceeds the energy amount endpoint; 10. An electrosurgical generator according to claim 9.

11. the controller triggers a notification when the count exceeds the energy amount endpoint and transmits the notification to an external device via a communication module.

10. An electrosurgical generator according to claim 9.

12. the memory stores a predetermined energy dose endpoint for each of a plurality of treatments; 10. An electrosurgical generator according to claim 9.

13. the input / output interface allows selection of at least one of the plurality of treatments, and upon selection of at least one treatment, the controller retrieves a corresponding energy dose end point from the memory; 13. An electrosurgical generator according to claim 12.

14. a communication module configured to receive from an external device the predetermined energy dose endpoint for each of the plurality of treatments; 13. An electrosurgical generator according to claim 12.

15. the at least one energy quantification function is selected based on a type of applicator.

10. An electrosurgical generator according to claim 1.

16. the at least one energy quantification function is received from the applicator upon coupling the applicator to at least one receptacle of an electrosurgical generator.

10. An electrosurgical generator according to claim 1.

17. an input / output interface that allows storing in memory a total count of the amount of energy delivered to the first treatment area of ​​the patient as an end point of the amount of energy; Upon selection of a treatment for a treatment region on the opposite side of the patient, the controller retrieves from the memory a stored energy dose end point.

10. An electrosurgical generator according to claim 1.

18. Upon completion of treatment for a first treatment region of the patient, the controller determines a total amount of energy delivered to the patient tissue and stores the determined total amount of energy in the memory as an energy amount endpoint for treatment for a contralateral treatment region of the patient.

10. An electrosurgical generator according to claim 1.

19. an input / output interface that allows selection of a treatment for the opposite treatment area; Upon selection of the treatment, the controller retrieves the stored energy dose end point from the memory.

20. An electrosurgical generator according to claim 18.

20. a flow controller for providing at least one gas to the applicator; the applicator generates a plasma from the electrosurgical energy and the at least one gas, and the plasma is delivered to the patient tissue.

10. An electrosurgical generator according to claim 1.

21. the controller counts the amount of 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 a generator power setting of an electrosurgical generator.

21. An electrosurgical generator according to claim 20.

22. an input / output interface for displaying the count of the amount of energy delivered to the patient tissue; the count of the amount of energy delivered to the patient tissue is displayed in Joules.

22. An electrosurgical generator according to claim 21.

23. an input / output interface for displaying the amount of energy delivered to the patient tissue; the amount of energy delivered to the patient tissue is expressed in joules per second.

22. An electrosurgical generator according to claim 21.

Images