Electrosurgical system

Abstract

To provide an electrosurgical system for sealing and cutting tissue. [Solution] An electrosurgical system is provided, which includes a bipolar electrosurgical instrument and an electrosurgical generator. The bipolar electrosurgical instrument is positioned to seal and cut tissue trapped between the jaws of the bipolar electrosurgical instrument. The electrosurgical generator is positioned to supply RF energy through the bipolar electrosurgical instrument, monitor the supplied RF energy, and adjust or terminate the supplied RF energy to optimally seal the tissue.

Description

Technical Field

[0001] 〔Cross - Reference to Related Applications〕 This application claims priority and the benefit thereof to U.S. Provisional Patent Application No. 62 / 768,782, entitled “Electrosurgical System,” filed on Nov. 16, 2018, which is incorporated herein by reference in its entirety.

[0002] This application generally relates to electrosurgical systems and methods. More specifically, this application relates to electrosurgical generators and related instruments for sealing and cutting tissue.

Background Art

[0003] There are available electrosurgical devices or instruments that use electrical energy to perform certain surgical tasks. Typically, an electrosurgical instrument is a surgical instrument such as a capture instrument, scissors, forceps, blade, and / or needle that is configured to receive electrical energy from an electrosurgical generator. The electrical energy can be used to coagulate, lyse, or cut tissue.

[0004] Electrosurgical instruments typically fall into two categories: monopolar and bipolar. In a monopolar instrument, electrical energy is supplied at a high current density to one or more electrodes on the instrument, while an individual return electrode is electrically coupled to the patient. The individual return electrode is often designed to minimize the current density. Monopolar electrosurgical instruments can be useful in certain procedures, but may carry the risk of certain types of problems such as electrical burns that can be partially attributed to the function of the return electrode.

[0005] In a bipolar electrosurgical instrument, one or more electrodes are electrically coupled to a source of electrical energy of a first polarity. In addition, one or more other electrodes are electrically coupled to a source of electrical energy of a second polarity, opposite to the first polarity. Bipolar electrosurgical instruments, which operate without separate return electrodes, can deliver electrical signals to the tissue area of ​​interest with reduced risk compared to unipolar electrosurgical instruments. [Prior art documents] [Patent Documents]

[0006] [Patent Document 1] U.S. Patent Application No. 12 / 416, 668 [Patent Document 2] U.S. Patent Application No. 12 / 416, 751 [Patent Document 3] U.S. Patent Application No. 12 / 416, 695 [Patent Document 4] U.S. Patent Application No. 12 / 416, 765 [Patent Document 5] U.S. Patent Application No. 12 / 416, 128 [Patent Document 6] U.S. Patent Application No. 14 / 848, 116 [Patent Document 7] U.S. Provisional Patent Application No. 61 / 994, 215 [Patent Document 8] U.S. Provisional Patent Application No. 61 / 994, 185 [Patent Document 9] U.S. Provisional Patent Application No. 61 / 994, 415 [Patent Document 10] U.S. Provisional Patent Application No. 61 / 944, 192 [Overview of the project] [Problems that the invention aims to solve]

[0007] However, even with the relatively concentrated surgical effects of bipolar electrosurgical instruments, surgical outcomes often depend heavily on the surgeon's skill. For example, thermal tissue damage and necrosis can occur when electrical energy is delivered over a relatively long duration or when relatively high-power electrical signals are delivered over a short duration. The rate at which tissue achieves the desired dissolution, sealing, or cutting effect upon application of electrical energy varies depending on the tissue type and may also vary depending on the pressure applied to the tissue by the electrosurgical device. However, it can be difficult for surgeons to assess how quickly and in what quantity a complex tissue mass captured by an electrosurgical instrument will be sealed. [Means for solving the problem]

[0008] Disclosed herein are methods, devices, and systems for dissolving or sealing tissue. A first embodiment describes a method for dissolving or sealing tissue. This method begins by first applying a first amount of RF energy to an area of ​​tissue. The dryness level of the area of ​​tissue affected by the first amount of RF energy is then determined. Based on the determined dryness level, the amount of RF energy is reduced to a second amount. Following the reduction to the second amount of RF energy, an increasing amount of RF energy is applied to the area of ​​tissue until a third amount is reached. The rate at which the RF energy is added and the third amount are based on the determined dryness level. The third amount of RF energy is applied to the area of ​​tissue over a predetermined period of time. After the predetermined period has elapsed, the application of RF energy to the area of ​​tissue is terminated.

[0009] Another embodiment describes an electrosurgical generator used to dissolve or seal tissue. The electrosurgical generator includes a controller and an RF amplifier that generates a corresponding amount of RF energy based on commands provided by the controller. The controller first commands the RF amplifier to apply a first amount of RF energy to an area of ​​tissue. The controller then determines the dryness level of the area of ​​tissue affected by the first amount of RF energy. The controller then commands the RF amplifier to first reduce the amount of RF energy to a second amount based on the determined dryness level, and then increase the amount of RF energy applied to the area to a third amount. The rate at which the RF energy is added and the third amount are based on the determined dryness level. The controller commands the RF amplifier to maintain the third amount of RF energy applied to the area of ​​tissue for a predetermined period of time. After the predetermined period has elapsed, the controller commands the RF amplifier to terminate the application of RF energy to the area of ​​tissue.

[0010] Another embodiment describes a system for dissolving or sealing tissue. The system includes an electrosurgical generator that generates RF energy and an electrosurgical instrument for dissolving or sealing a tissue area. The electrosurgical instrument receives RF energy from the electrosurgical generator to dissolve or seal the tissue area. The amount of RF energy generated and supplied to the electrosurgical instrument for use in dissolving or sealing the tissue area is based on a determined dryness level of the tissue area.

[0011] To illustrate how the other advantages and features of the disclosure of the present invention can be obtained as enumerated above, a more detailed explanation of the principles briefly described above is provided below with reference to specific embodiments shown in the accompanying drawings. With the understanding that these drawings are solely for illustrating embodiments of the disclosure of the present invention and are therefore not intended to limit its scope, the principles of this specification will be explained and described with additional specificity and detail through the use of the accompanying drawings, where reference numbers indicate similar parts throughout the drawings. [Brief explanation of the drawing]

[0012] [Figure 1] A perspective view of an electrosurgical system according to various embodiments of the present invention. [Figure 2] A perspective view of an electrosurgical instrument according to various embodiments of the present invention. [Figure 3] A perspective view of an electrosurgical instrument according to various embodiments of the present invention. [Figure 4] A diagram of a graphic display of experimental data samples related to a sealing process or aspects thereof using an electrosurgical system according to various embodiments of the present invention. [Figure 5] A diagram of a graphic display of experimental data samples related to a sealing process or aspects thereof using an electrosurgical system according to various embodiments of the present invention. [Figure 6] A diagram of a graphic display of experimental data samples related to a sealing process or aspects thereof using an electrosurgical system according to various embodiments of the present invention. [Figure 7] A diagram of a graphic display of experimental data samples related to a sealing process or aspects thereof using an electrosurgical system according to various embodiments of the present invention. [Figure 8] A schematic block diagram of each part of an electrosurgical system according to various embodiments of the present invention. [Figure 9] A diagram of a graphic display of experimental data samples related to a sealing process or aspects thereof using an electrosurgical system according to various embodiments of the present invention. [Figure 10] A flowchart showing the operation of an electrosurgical system according to various embodiments of the present invention.

Embodiments for Carrying Out the Invention

[0013] Various embodiments provide electrosurgical instruments configured to dissolve and cut tissue. In various embodiments, the electrosurgical device or instrument includes a first jaw and a second jaw. The second jaw is opposed to the first jaw and facilitates the trapping of tissue between the first and second jaws. Both the first and second jaws include electrodes. The electrodes of the first and second jaws are arranged to seal the trapped tissue between the first and second jaws using radio frequency (RF) energy.

[0014] Various embodiments also provide electrosurgical systems for sealing tissue. In various embodiments, the electrosurgical system comprises an electrosurgical generator and an electrosurgical instrument or device. The electrosurgical generator includes an RF amplifier and a controller. The RF amplifier supplies RF energy through an electrosurgical instrument that is detachably coupled and configured to seal tissue using only RF energy. A controller and / or RF sensor are arranged to monitor and / or measure the supplied RF energy and / or its components. In various embodiments, the controller signals the RF amplifier to adjust the voltage of the supplied RF energy at predetermined points or conditions in the sealing cycle, for example, by increasing, holding, decreasing, and / or stopping. In various embodiments, the controller signals the RF amplifier to pause the supplied RF energy or to initiate the termination of the RF energy supplied by the RF amplifier.

[0015] The various features and embodiments provided throughout can be used individually or in combination with other features and / or embodiments not explicitly described, and certain combinations of embodiments and features or aspects of various embodiments may not be explicitly described, but such combinations are conceivable and within the scope of the present invention. Many of the features accompanying the present invention will be more readily apparent and better understood by considering the above and below descriptions together with the accompanying drawings.

[0016] Generally, an electrosurgical system is provided which includes an electrosurgical generator configured to optimally seal or dissolve tissue, and a detachably coupled electrosurgical instrument. RF energy is supplied by the electrosurgical generator, which is positioned to provide appropriate RF energy for sealing the tissue. In various embodiments, the electrosurgical generator determines the appropriate RF energy and appropriate manner for delivering the RF energy for a particular connected electrosurgical instrument, a particular tissue in contact with the electrosurgical instrument, and / or a particular surgical procedure being performed. Operationally, RF sealing or dissolution of tissue between jaws is provided to reduce sealing time and / or thermal diffusion.

[0017] In various embodiments, the electrosurgical system includes a dynamic pulse system configured to control and interrupt the delivery of RF energy, resulting in an optimal balance of hemostatic reliability, sealing time, and tissue adhesion over a wide range of tissues. In various embodiments, the electrosurgical system includes a double or repeatable sealing system configured to reduce the application of RF energy to multiple activations in order to reduce crusting (sealed tissue debris) accumulation, tissue adhesion, and thermal diffusion to already sealed tissue.

[0018] Referring to both Figures 1 and 2, exemplary embodiments of an electrosurgical system are shown. The electrosurgical system includes an electrosurgical generator 10 (shown in Figure 1) and a detachably connectable electrosurgical instrument 20 (shown in Figure 2). The electrosurgical instrument 20 can be electrically coupled to the electrosurgical generator 10 through a cable connection 30 having an adapter 32 configured to connect to a tool or device port 12 on the electrosurgical generator 10. The electrosurgical instrument 20 may include audible, tactile, and / or visual indicators to notify the user of specific predetermined statuses of the electrosurgical instrument 20, such as the start and / or end of a dissolution or cutting operation. In other embodiments, the electrosurgical instrument 20 may be reusable and / or connectable to another electrosurgical generator for another surgical procedure. In some embodiments, a manual controller, such as a hand or foot switch, may be connectable to the electrosurgical generator 10 and / or the electrosurgical instrument 20, allowing for predetermined selective control of the electrosurgical instrument 20, such as to initiate a dissolution or cutting operation.

[0019] In various embodiments, the electrosurgical generator 10 is configured to generate radio frequency (RF) electrosurgical energy and to receive data or information from an electrosurgical instrument 20 electrically coupled to the electrosurgical generator 10. In one embodiment, the electrosurgical generator 10 outputs RF energy (e.g., 375 VA, 150 V, 5 A at 350 kHz) and, in one embodiment, is configured to measure the current and / or voltage of the RF energy during activation or supply of the RF energy and / or to calculate the power of the RF energy, or the phase angle or phase difference between the RF output voltage and the RF output current. The electrosurgical generator 10 adjusts the voltage, current, and / or power and monitors the RF energy output (e.g., voltage, current, power, and / or phase). In one embodiment, the electrosurgical generator 10 stops the RF energy output when a device switch is asserted to stop (e.g., when the dissolution button is released), when a time value is satisfied, and / or when the active phase angle, current, voltage, or power and / or the change thereto is greater than, less than, or equal to a stop value, threshold, or condition and / or the change thereto.

[0020] As shown in Figure 1, the electrosurgical generator 10 includes at least one modern bipolar tool port 12, a standard bipolar tool port 16, and a power port 14. In other embodiments, the electrosurgical unit may include a different number of ports. For example, in some embodiments, the electrosurgical generator 10 may include more or fewer than two modern bipolar tool ports, more or fewer than one standard bipolar tool port, and more or fewer than the power port. In one embodiment, the electrosurgical generator 10 includes only two modern bipolar tool ports.

[0021] In various embodiments, each state-of-the-art bipolar tool port 12 is configured to be coupled to a state-of-the-art electrosurgical instrument having a mountable or integrated memory module. A standard bipolar tool port 16 is configured to accept non-specialized bipolar electrosurgical tools, different from the state-of-the-art bipolar electrosurgical instruments that can be connected to the state-of-the-art bipolar tool port 12. A power port 14 is configured to accept or be connected to a direct current (DC) auxiliary device, different from the non-specialized bipolar electrosurgical tools and the state-of-the-art electrosurgical instruments. The power port 14 is configured to supply a DC voltage. For example, in some embodiments, the power port 14 can provide approximately 12 volts of DC. The power port 14 can be configured to power surgical accessories such as ventilators, pumps, lights, or other surgical accessories. Thus, in addition to replacing standard or non-specialized bipolar tools with the electrosurgical generator 10, the electrosurgical generator 10 can replace the power supply for surgical accessories. In some embodiments, replacing existing generators and power supplies with the electrosurgical generator 10 can reduce the amount of storage space required on storage rack cards or shelves and reduce the number of main power cords required in the surgical workspace.

[0022] In various embodiments, the electrosurgical generator 10 may include a display 15. The display 15 may be configured to show the status of the electrosurgical system, including, among other information, the status of one or more electrosurgical instruments and / or accessories, connectors or connections thereto.

[0023] In various embodiments, the electrosurgical generator 10 may include a user interface such as a plurality of buttons 17. The plurality of buttons 17 can enable user interaction with the electrosurgical generator 10 (e.g., receiving user input), such as requesting an increase or decrease in electrical energy supplied to one or more electrosurgical instruments connected to the electrosurgical generator 10. In other embodiments, the display 15 may be a touchscreen display, thereby integrating data display and user interface functions. In one embodiment, the electrosurgical tool or instrument 20 may further include one or more memory modules. In some embodiments, the memory contains operational data relating to the electrosurgical instrument and / or other instruments. For example, in some embodiments, the operational data may include information regarding electrode configuration / reconfiguration, use of the electrosurgical instrument, operating time, voltage, power, phase, and / or current setpoints, and / or information relating to specific operating status, conditions, scripts, processes, or procedures. In one embodiment, the electrosurgical generator 10 may initiate reading and / or writing to the memory modules.

[0024] In various embodiments, the electrosurgical generator 10 provides the ability to read the phase difference or phase angle between the voltage and current of the RF energy transmitted through the connected electrosurgical instrument 20 while the RF energy is active. While tissue is being dissolved, the phase readings are used to detect different states during the dissolution or sealing and cutting processes.

[0025] In various embodiments, the electrosurgical generator 10 monitors, measures, or calculates the current, power, impedance, or phase of the RF output, but does not control the current, power, impedance, or phase. The electrosurgical generator 10 can also adjust and modulate the voltage. The delivered electrosurgical power is a function of the applied voltage, current, and tissue impedance. The electrosurgical generator 10 can influence the delivered electrosurgical power, RF output, or energy through voltage adjustment. The power response is caused by power interacting with tissue or tissue state without any control by the generator other than the powering generator.

[0026] Once the electrosurgical generator 10 has started supplying electrosurgical power, it continues to do so continuously, for example, for 150 ms, until a failure occurs or a specific parameter is reached. In one example, the jaws of the electrosurgical instrument can be opened at any time before, during, or after the application of electrosurgical power to reduce compression. Similarly, in one embodiment, the electrosurgical generator 10 does not pause or wait for a specific duration or predetermined delay time before initiating the termination of the electrosurgical energy.

[0027] Referring further to Figure 3, various embodiments of the bipolar electrosurgical instrument 20 are provided. In the illustrated embodiment, the bipolar electrosurgical instrument 20 includes an actuator 24 coupled to an elongated rotatable shaft 26. The elongated rotatable shaft 26 has a proximal end and a distal end, with a central longitudinal axis defined between them. The distal end of the elongated rotatable shaft 26 has a jaw portion 22, and the proximal end has the actuator 24. In one embodiment, the actuator 24 is a pistol grip-shaped handle.

[0028] The actuator 24 includes a movable handle 23 and a fixed handle or housing 28. The movable handle 23 is coupled to the fixed housing 28 and is movable. In various embodiments, the movable handle 23 is slidably and pivotably coupled to the fixed housing 28. In operation, the movable handle 23 is operated by a user, for example, a surgeon, to actuate the jaw, for example, to selectively open and close the jaw 22.

[0029] In various embodiments, the actuator 24 includes a latch mechanism for maintaining the movable handle 23 in a second position relative to the fixed housing 28. In various embodiments, the movable handle 23 has a latch arm that engages with a matching latch enclosed in the fixed handle or housing 28 to hold the movable handle 23 in the second or closed position. Similarly, in various embodiments, the actuator 24 has a wire harness including individual insulated electrical wires or leads enclosed in a single sheath. The wire harness may exit the fixed housing 28 on its underside and form part of a cable connection 30 (as shown in Figure 2). The wires in the harness can provide electrical communication between the electrosurgical instrument 20 and the electrosurgical generator 10 and / or its accessories.

[0030] In various embodiments, the switch is connected to a user-operated activation button 29 and is activated when the activation button 29 is pressed down. In one embodiment, when activated, the switch completes the circuit by electrically coupling at least two leads. In this way, an electrical path is established from the electrosurgical generator 10 to the actuator 24, supplying RF energy to the electrosurgical instrument 20. In various embodiments, the electrosurgical instrument 20 has a translatable mechanical cutting blade that can be coupled to a blade actuator such as a blade lever or trigger 25 of the actuator 24. The mechanical cutting blade is activated by the blade trigger 25 to divide the tissue between the jaw portions 22.

[0031] In one embodiment, the actuator 24 includes an elongated rotatable shaft 26 assembly, which includes a rotary knob 27 positioned on an outer cover tube of the elongated rotatable shaft 26. The rotary knob 27 allows the surgeon to rotate the elongated rotatable shaft 26 of the electrosurgical instrument 20 while gripping the actuator 24. In various embodiments, the elongated rotatable shaft 26 has an actuation tube that connects the jaw portion 22 to the actuator 24.

[0032] Attached to the distal end of the elongated rotatable shaft 26 is a jaw 22 having a first or upper jaw 31 and a second or lower jaw 33. In one embodiment, a jaw pivot pin pivotably connects the first jaw 31 and the second jaw 33, allowing the first jaw 31 to be movable and pivot rotation relative to the second jaw 33. In various embodiments, one jaw is fixed to the elongated rotatable shaft 26, so that the opposing jaws pivot rotation between an open position and a closed position relative to the fixed jaw. In other embodiments, both the first jaw 31 and the second jaw 33 can be pivotably connected to the elongated rotatable shaft 26, so that both the first jaw 31 and the second jaw 33 can pivot rotation relative to each other.

[0033] The first or upper jaw portion 31 includes an electrode plate or pad. Similarly, the second or lower jaw portion 33 also includes an electrode plate or pad. The electrodes of the first or upper jaw portion 31 and the electrodes of the second or lower jaw portion 33 are electrically coupled to the electrosurgical generator 10 via wires and connectors to supply RF energy to the tissue trapped between the electrodes of the first and second jaw portions 33. Thus, these electrodes have opposite polarity and are arranged to transmit RF energy between them. In various embodiments, the first or upper jaw portion 31 also includes an upper jaw support, and an assembly spacer is positioned between the upper jaw support and the electrodes. Likewise, the first or upper jaw portion 31 includes or is overmolded. The second or lower jaw portion 33 may also include a lower jaw support and electrodes. In the illustrated embodiment, the electrodes are integrated into or incorporated into the lower jaw support, so that the lower jaw support and the electrodes form a monolithic structure and an electrical connection. The blade channel extends longitudinally along the length of the first or upper jaw 31, the second or lower jaw 33, or both, through which the blade operatively passes. One or more conductive posts surround a portion of the blade channel. The conductive posts assist in immobilizing the tissue being cut. Similarly, the conductive posts are also involved in the transfer of RF energy to the tissue trapped between the jaws 22, thus helping to ensure that the tissue being cut adjacent to or near the blade channel is dissolved. The second or lower jaw 33 may also include, or is overmolded, an overmolded portion.

[0034] In various embodiments, the electrodes have a substantially planar sealing surface positioned to contact and compress the tissue trapped between the jaw portions 22. In various embodiments, the electrodes of the first or upper jaw portion 31 and the second or lower jaw portion 33 have a sealing surface whose width remains uniform, constant, or unchanging throughout.

[0035] In various embodiments, the jaw portion 22 is curved at the target surgical site to enhance visibility and mobility of the jaw portion 22 during the surgical procedure. The jaw portion 22 has a proximal elongated portion that indicates or aligns with a straight line, and a curved distal portion that indicates or defines a curved portion connected to the straight line. In various embodiments, the nearest portion of the proximal elongated portion has or defines a diameter equal to or not exceeding the maximum outer diameter of the jaw portion 22 or the elongated rotatable shaft 26. In various embodiments, the jaw portion 22 has a maximum outer diameter in which the nearest portion of the jaw portion 22 and the most distal portion of the jaw portion 22 remain. The curved distal portion has or defines a diameter smaller than the maximum outer diameter and the diameter of the nearest portion of the proximal elongated portion. In various embodiments, the jaw portion 22 has a notch in the medial curve that is deeper than the lateral curve, and in various embodiments, the tip of the jaw portion 22 is tapered for blunt incisions. The jaw portion 22 includes a blade channel in which a proximal elongated channel curves into a distal curved channel, in which case the proximal elongated channel is parallel to and offset from the longitudinal axis of the elongated rotatable shaft 26 of the electrosurgical instrument 20. Thus, visibility and mobility in the jaw portion 22 are maintained or enhanced without further reducing the surgical working area or increasing the dimensions of the jaw portion which may require a larger access device or incision into the patient's body.

[0036] In some embodiments, the electrode shape of the conductive pads of the jaw assembly ensures that the sealing area or surface completely encloses the distal portion of the cutting path. In various embodiments, the dimensions of the jaw surface are related to the optimal pressure applied to the tissue between the jaws 22 and are appropriately proportional to the potential force that its force mechanism can generate. Similarly, its surface area is electrically important with respect to the area in contact with the tissue. The ratio of this area to the tissue thickness is optimized in relation to the relative electrical properties of the tissue.

[0037] In various embodiments, the second or lower jaw portion 33 and associated conductive pads have upper outer surfaces positioned to contact tissue. These upper surfaces are angled or inclined and mirror images of each other, and such positioning or orientation facilitates concentrated current density and tissue fixation. In various embodiments, the second or lower jaw portion 33 may be made of stainless steel and have a rigidity equal to or greater than that of the conductive pads. In various embodiments, the second or lower jaw portion 33 includes rigid insulators that can be made of non-conductive materials and have a rigidity equal to or greater than that of the second or lower jaw portion 33 or the conductive pads. In various embodiments, the second or lower jaw portion 33 and the conductive pads may be made of the same material.

[0038] In various embodiments, the RF energy control process or system supplies and controls the supplied RF energy to seal or dissolve tissue. At the start of the sealing cycle, the system of the present invention is configured to apply RF energy having a rapidly increasing voltage. Thus, the system of the present invention supplies RF energy having an increasing voltage over a minimum period of time, and as a result, the supplied RF energy has a voltage profile with a steep gradient or rate of change. In various embodiments, the system of the present invention attempts to continuously increase the voltage of the RF energy to identify or determine an RF output peak condition. In various embodiments, the RF output peak condition is indicated by the maximum current or power value resulting from the increasing voltage of the supplied RF energy. In various embodiments, the system of the present invention attempts to increase the voltage of the supplied RF energy up to and / or equal to this RF output peak condition. However, the step of determining this RF output peak condition or peak point may vary based on the type and / or volume of tissue in contact with the electrodes of the electrosurgical instrument. Therefore, the high-voltage ramp or pulse provided by the system of the present invention has a variable duration based on the tissue in contact with the instrument, rather than a static, fixed, or predetermined value, as illustrated in Figure 4. Similarly, electrode size and electrode contact with tissue can further lead to variations in these RF output peak conditions. Therefore, determining the RF output peak conditions can be difficult.

[0039] As the system of the present invention attempts to reach this changing RF output peak condition, the amount of time the system of the present invention or the electrosurgical generator supplies RF energy may also change. For example, as shown in Figure 5, the peak condition 121 occurs at different times for tissues of different volumes. For example, tissues with smaller volumes may experience their respective peak conditions much earlier in the sealing cycle compared to possible tissues with much larger volumes (e.g., delayed by about 1250 ms in the sealing cycle). Thus, in various embodiments, the peak conditions generally occur later for thicker tissues because thicker tissues take more time to heat up. In addition, the peak height may depend on the area of ​​the tissue. Larger tissues may have higher peak values ​​because there is more tissue that acts as or behaves as electrically parallel resistances. However, in various embodiments, the amount of time for rapidly increasing the RF energy voltage applied to the tissue is limited to a set maximum time threshold or limit, thereby avoiding applying RF energy for longer than necessary. Setting a fixed time without attempting to reach the RF output peak condition may result in applying RF energy for longer than necessary, especially when the tissue volume is small. In addition, using a fixed time frame may result in insufficient RF energy application time, especially when the tissue volume is large.

[0040] Therefore, by providing a dynamic voltage ramp in various embodiments, system performance is balanced at each end, enabling near-ideal or optimal RF energy delivery early or sooner, ultimately resulting in optimal tissue sealing. By rapidly achieving this RF output peak condition, the entire tissue sealing process is optimized, and sealing time is reduced without compromising or reducing tissue integrity. In various embodiments, the electrosurgical generator provides this dynamic voltage ramp or pulse by initially adjusting the RF energy voltage to be relatively high (e.g., more than 40% above the maximum voltage) and rapidly increasing the RF energy voltage (e.g., at a rate of 10 volts per millisecond) to achieve the RF output peak condition.

[0041] By using a dynamic ramp, for example, any tissue can be quickly brought to the same RF output peak conditions or moisture evaporation point, regardless of volume. Therefore, the possibility of the tissue failing to reach or maintain the moisture evaporation point (underpulse) is reduced. Reducing the possibility of underpulse allows for a shorter average RF delivery time or reduced power after the pulse, without affecting the quality of the seal. In addition, the focus or attention of the system of this invention can be directed towards efficiently removing water from the tissue rather than towards tissue heating and associated variability.

[0042] As described above, determining when RF output peak conditions occur is difficult, especially in real time. Noise or similar fluctuations or inaccuracies in RF output measurements can obscure or delay the determination of RF output peak conditions. In various embodiments, smoothing or filtering such inaccuracies may help enhance the detection or determination of RF output peak conditions. However, delays such as filtering in various embodiments can delay the determination of RF output peak conditions. Delays in identifying the determination of RF output peak conditions may cause the system of the present invention to overpulse tissue.

[0043] In various embodiments, to avoid or reduce this delay in identifying RF output peak conditions or the possibility of overpulsing the tissue, the system of the present invention can provide an interruption system. The interruption system utilizes a predetermined interruption value based on an expected maximum value or window representing the RF output peak condition. In various embodiments, the interruption value is a percentage of the expected maximum value and / or a fixed threshold or gap (e.g., 400mA or 30W) below the expected maximum value or within the window. The system of the present invention monitors the RF output, e.g., current and / or power, and the interruption system ensures that the monitored current and / or power reaches this interruption value before the voltage is regulated, e.g., drops, thus ensuring that the RF output peak condition is identified quickly and accurately, thereby balancing the interests of both. However, it is recognized that if the interruption value offset is small or large and below the expected maximum value, the time during which the RF output is subjected to a particularly high voltage (e.g., overpulse) will be longer, but the likelihood of the system of the present invention prematurely interrupting or reducing the RF output voltage (e.g., underpulse) due to, for example, noise triggering, is low.

[0044] In various embodiments, the system of the present invention records or stores an expected maximum value and checks whether the next monitored value exceeds the stored expected maximum value. If it exceeds the maximum value, the monitored value is stored as the "new" maximum value. In various embodiments, the system of the present invention monitors or records the RF output at set intervals, such as every 50 ms, and compares the value of the RF output of interest with the stored expected maximum value to determine whether a new maximum value has occurred.

[0045] In various embodiments, the system of the present invention utilizes a series of states in which termination conditions are set at regular intervals. When RF energy is applied and the value of interest changes (e.g., power and / or current increases), the states progress or cascade. Increasing the number of states increases the resolution of the cascade. However, depending on the resolution of the cascade, the accuracy of determining the RF output peak condition may be somewhat compromised, although the cascading or similar progression of states is computationally less intensive and does not require or minimizes the use of variables.

[0046] In various embodiments, the interruption value or range is calculated by multiplying the expected maximum value by a percentage (e.g., 80%). A higher expected maximum value may require a larger drop in the value of interest (e.g., current or power) to trigger or identify the RF output peak condition. In various embodiments, the interruption value or range is calculated by subtracting a fixed offset (e.g., 400mA or 30W) from the expected maximum value. Depending on the expected maximum value, this may result in a value smaller or larger than the percentage calculation, but it may be useful to set the offset to account for inaccuracies (e.g., set higher than the noise amplitude) if the noise amplitude or similar inaccuracies of the system of the present invention are known. The value of interest (e.g., current or power) can be compared with the interruption value to ensure that the peak is reliably detectable, and in some scenarios, the value of interest (e.g., current or power) must reach at least the interruption value before any adjustments are made to the voltage to ensure that the peak can be reliably identified. In various embodiments, the system of the present invention provides modifications of combinations and / or sequences of offsets and percentages that act in parallel or sequentially when the expected maximum value reaches a certain threshold in situations where a larger drop of the value of interest to trigger is undesirable, for example, to account for known inaccuracies, thereby enhancing the identification or determination of RF output peak conditions.

[0047] In various embodiments, the system of the present invention monitors the rate of change of a value of interest (e.g., current and / or power) to determine or predict RF output conditions. Accordingly, the system of the present invention monitors the derivative or rate of change of the value of interest and its transition (e.g., change or reduction in rate of change) to identify RF output peak conditions, or signs that RF output peak conditions are imminent or likely to occur.

[0048] In various embodiments, the system of the present invention is configured to adjust the current of the RF output to determine the RF output peak condition. In particular, the system of the present invention, for example, the RF amplifier of a generator, gradually ramps up the current of the supplied RF energy, and the generator is placed in a current-regulated state. When the current-regulated value exceeds the capacity of the tissue to accept more current, the system of the present invention is no longer current-regulated, and as a result, the voltage increases sharply when the system of the present invention switches the regulation. Thus, this voltage condition is used as an indicator or determining value of the RF output peak condition. Consequently, this system regulation can be avoided by refraining from using a value of interest that is stored or utilized as provided by a percentage or offset system or process.

[0049] In various embodiments, if an error or unexpected result occurs, the system of the present invention terminates the process, for example, the supply of RF energy. In various embodiments, such errors include short-circuit detection errors or open-circuit detection errors. In one embodiment, a short-circuit detection error is determined by the electrosurgical generator when the measured phase angle of the RF energy supplied by the electrosurgical generator is equal to or greater than a predetermined value, e.g., 60 degrees. In one embodiment, an open-circuit detection error is determined by the electrosurgical generator when the measured current of the supplied RF energy is equal to or less than a predetermined value, e.g., 100 mA, and / or the measured voltage of the supplied RF energy is equal to or greater than a predetermined value, e.g., 50 V. Completion of the control process without errors indicates successful tissue sealing. In various embodiments, successful tissue sealing is recognized as being able to withstand a predetermined range of burst pressure or a specific threshold pressure.

[0050] In various embodiments, the formation of tissue seals has been confirmed to depend on the denaturation and crosslinking of innate collagen present in the extracellular matrix of vascular systems, which begins at approximately 60°C. The strength of this matrix largely depends on the drying (or removal of moisture) at the sealing site due to the evaporation of moisture present in the sealed tissue. In addition, bonding can be generated between the denatured collagen and other biological tissues at temperatures of at least 80°C. Furthermore, the collagen degrades depending on the duration of exposure to high temperatures, rather than the peak temperature of exposure. Therefore, exposing the tissue to high-temperature conditions (e.g., 100°C) during the duration of a relatively short sealing cycle does not affect the structure of the collagen but allows for moisture evaporation. In various embodiments, the total time for sealing the tissue depends on the step of heating the structure to a high temperature, e.g., 100°C, to evaporate water so that the denatured collagen crosslinks and binds with the tissue, and to limit the collagen-water hydrogen bonds. Therefore, it has been found that to optimize the sealing time, it is desirable to achieve 100°C in the captured tissue and initiate the drying process as quickly as possible.

[0051] Accordingly, in various embodiments, after the RF energy has been activated and / or after various device checks have been performed, the electrosurgical generator uses a dynamic voltage ramp through the supplied RF energy. With the dynamic voltage ramp complete, the system of the present invention reduces the voltage to a predetermined level and slowly ramps up the voltage of the supplied RF energy. During ramp generation, a sufficient amount of energy is applied to the tissue to maintain a temperature sufficient for drying. This allows for continuous evaporation at a rate that does not cause structural damage to the seal, thereby improving the sealing performance of the blood vessels.

[0052] In one embodiment, applying a high voltage level may cause the sealed tissue to adhere to the active electrode. Therefore, by ending the voltage ramp at a lower peak voltage and finally maintaining the voltage output constant, it is possible to continue energy application while reducing the possibility of tissue adhesion to the active electrode. The timing of ending the voltage ramp is determined by monitoring the phase and current of the supplied RF energy in various embodiments. As the tissue dries, the phase becomes more capacitive and the current draw decreases. By ending the voltage ramp at a fixed current value when the current decreases and the phase becomes capacitive, the level of tissue dryness can be classified. This variable voltage setting allows the energy application to be adjusted in the sealing cycle based on the electrical and structural differences of the sealed tissue.

[0053] In various embodiments, the phase angle, current, and / or power of the applied RF energy are measured, calculated, and / or monitored to achieve proper organizational operation. Figures 4 to 7 provide a graphical representation of exemplary sealing cycles according to various embodiments. As shown in Figure 7, voltage 111a is shown in comparison to other RF output readings or indicators such as power 111b, impedance 111c, energy 111d, current 111e, and phase 111f. In addition, as shown in Figures 4 to 7, in various embodiments, the electrosurgical generator may be configured not to measure or calculate one or more of the indicators or readings (e.g., impedance) in order to reduce operating and power costs and wear and tear, and / or to reduce the number of components in the electrosurgical generator. Additional information or readings are generally provided or displayed for relevant purposes. In addition, in various embodiments, impedance or temperature readings may not be used or measured because such readings may be inaccurate or impractical.

[0054] As shown in Figure 7, the voltage of the RF output 111a increases over a relatively short period of time compared to the total sealing time at the beginning of the sealing cycle, generating a voltage ramp or pulse 131 (shown in Figure 6) of RF energy. In various embodiments, the system of the present invention is configured to determine or reach an RF output peak condition 121. Subsequently, after reaching the RF output peak condition 121, the RF energy voltage decreases and ramps up more gradually than the voltage pulse. In various embodiments, the gradual voltage ramp 132 by the system of the present invention attempts to maintain the interjaw tissue at at least close to 100°C, thereby controlling the boiling rate of water in the tissue. In various embodiments, the phase angle, current, and / or power of the applied RF energy are monitored to achieve appropriate tissue action with respect to tissue sealing. Next, the RF energy voltage is kept constant to reduce the possibility of tissue adhesion (133). Upon completion of sealing (for example, within a predetermined time frame or period by the system of the present invention), the RF energy supplied by the system of the present invention is terminated, or the supply of RF energy is paused, interrupted, or stopped (134). In various embodiments, the RF energy voltage ramp is terminated, and after a predetermined period by the system of the present invention, the RF energy supplied by the system of the present invention is terminated, or the supply of RF energy is paused, interrupted, or stopped.

[0055] In various embodiments, the system of the present invention identifies unintended current draws provided by certain tissue bundles that draw the maximum current or power available from the generator. While the system of the present invention is under such current conditions, the supply of RF energy required to seal the tissue may be insufficient or not efficiently supplied by the system of the present invention. In various embodiments, to address such conditions, the system of the present invention determines whether the current of the RF energy output is greater than 90% of the maximum acceptable current, e.g., 4500 mA. If it is greater, the system of the present invention waits or delays further to ensure that the current has dropped sufficiently to indicate that the tissue has dried sufficiently. If, after such a delay, the current has not dropped sufficiently, an error is displayed and / or the supplied RF energy is suspended. In various embodiments, the system of the present invention determines or confirms that the current has dropped sufficiently when the current falls below a current threshold (e.g., 4100 mA). Thus, the system of the present invention determines that the current conditions have ended and / or the tissue has evaporated or reached peak conditions.

[0056] Referring to Figure 8, in one embodiment, the electrosurgical generator 10 is connected to the AC main input, and the power supply 41 converts the AC voltage from the AC main input to a DC voltage to power the various circuits of the electrosurgical generator 10. The power supply also supplies a DC voltage to an RF amplifier 42 that generates RF energy. In one embodiment, the RF amplifier 42 converts the DC 100V from the power supply into a sine wave having a frequency of 350kHz, which is transmitted through the connected electrosurgical instrument or tool 20. The RF sensor circuit 43 measures / calculates the voltage, current, power, and phase at the output of the electrosurgical generator 10 that supplies RF energy to the connected electrosurgical instrument or tool 20. The measured / calculated information is provided to the controller 44.

[0057] In one embodiment, the RF sensor 43 analyzes the measured AC voltage and current from the RF amplifier 42 to generate DC signals relating to control signals including voltage, current, power, and phase, which are then transmitted to the controller 44 for further processing. In one embodiment, the RF sensor 43 measures the output voltage and current and calculates the RMS values ​​of the voltage and current, the apparent power of the RF output energy, and the phase angle between the voltage and current of the RF energy supplied through the connected electrosurgical instrument or tool 20. In particular, the voltage and current of the output RF energy are processed by the analog circuitry of the RF sensor to generate real and imaginary components of both voltage and current. These signals are processed by a field-programmable gate array (FPGA) to give various measurements relating to voltage and current, including the RMS measurement of the AC signal, the phase shift between voltage and current, and power. Thus, in one embodiment, the output voltage and current are measured analogously, converted to digital, processed by the FPGA to calculate the RMS voltage and current, apparent power, and phase angle between voltage and current, and then converted back to analog for the controller 44.

[0058] In one embodiment, the controller 44 controls or signals the RF amplifier 42 to affect the output RF energy. For example, the controller 44 uses information provided by the RF sensor 43 to determine whether to output, regulate, or terminate the RF energy. In one embodiment, the controller 44 determines whether or not predetermined current, power, and / or phase thresholds have been reached or exceeded, or the time thereof, to determine when to terminate the output of the RF energy. In various embodiments, the controller 44 performs a dissolution or sealing process, which is described in more detail herein, and in some embodiments, the controller 44 receives commands, setpoints, or script data for performing the sealing process from data transmitted from the electrosurgical instrument or tool 20.

[0059] The RF amplifier 42 generates high-power RF energy that passes through the connected electrosurgical instrument or tool 20. In one example, the electrosurgical instrument or tool 20 is used to dissolve or seal tissue. In various embodiments, the RF amplifier 42 is configured to convert a DC 100V power supply into a high-power sinusoidal waveform having a frequency of 350kHz. The converted power is then sent to the connected electrosurgical instrument or tool 20. The RF sensor 43 interprets the measured AC voltage and current from the RF amplifier 42 and generates DC signals relating to control signals including voltage, current, power, and phase, which are interpreted by the controller 44.

[0060] The electrosurgical generator 10 (including the controller 44 and / or RF sensor 43) monitors and / or measures the supplied RF energy and determines whether it is as expected. In various embodiments, the system of the present invention (e.g., the controller and / or RF sensor) monitors the voltage and / or current of the RF energy and ensures that the voltage and current exceed predetermined thresholds. Similarly, the system of the present invention (e.g., the controller and / or RF sensor) monitors, measures, and / or calculates the phase and / or power of the supplied RF energy. The system of the present invention (e.g., the controller and / or RF sensor) ensures that the supplied RF energy voltage, current, phase, and / or power are within a predetermined window or range of voltage, current, phase, and / or power. In one embodiment, the voltage, current, phase, and / or power windows are each predetermined by a predetermined maximum voltage, current, phase, and / or power and a predetermined minimum voltage, current, phase, and / or power. An error is displayed if the voltage, current, phase, and / or power of the RF energy deviate from the respective windows. In one embodiment, each window is slid or adjusted by the system of the present invention when RF energy is supplied to seal tissue between the jaws of the instrument. The adjustment of each window is to ensure that the supplied RF energy is as expected. In various embodiments, the system of the present invention monitors the phase and / or current, or the rate of change of the phase and / or current, of the supplied RF energy and determines whether the phase and / or current has reached or crossed a predetermined phase and / or current threshold. If a phase and / or current crossover occurs in relation to the predetermined phase and / or current threshold, the RF energy is supplied for a predetermined period of time before termination.

[0061] In various embodiments, the operating engine of the controller 44 can be configured to adapt to a variety of operating scenarios, including but not limited to many different electrosurgical instruments or tools, surgical procedures, and preferences. The operating engine receives and interprets data from an external source and specifically configures the operation of the electrosurgical generator 10 based on the received data.

[0062] In various embodiments, the operating engine can receive configuration data from a database script file read from a memory device of the electrosurgical tool or instrument 20. The database script file defines the state logic used by the electrosurgical generator 10. Based on the state determined by the electrosurgical generator 10 and the measurements taken, the database script file can define or set cutoff criteria along with the output level for the electrosurgical generator 10. In one embodiment, the database script file includes trigger events, for example, an indication of a short-circuit condition when the measured phase is greater than 60 degrees, or an open-circuit condition when the measured current is less than 100 mA.

[0063] In various embodiments, tissues that draw relatively small amounts of current or power after a dynamic voltage ramp may be small in volume or already highly dry, as shown in Figure 9, for example. Highly dry tissue is commonly encountered in double or repeated sealing situations (for example, when a surgeon operates an instrument to supply RF energy again without moving the instrument or positioning it in a different part of the tissue or entirely different tissue after the initial sealing cycle or an already completed sealing cycle). Double or repeated sealing results in the application of additional RF energy, including heat, thereby increasing the possibility of crusting, heat diffusion, and / or adhesion. In various embodiments, the system of the present invention reduces or prevents RF output with high voltage when such repeated sealing is performed.

[0064] In various embodiments, the system of the present invention identifies or determines the dryness level of tissue in contact with an instrument. The system of the present invention identifies the dryness level of tissue using low levels of current or power, high levels of impedance, low phase angle, low energy delivery, and / or the absence of moisture evaporation (e.g., water vapor) during a sealing cycle. With the dryness level of tissue identified, the RF output is reduced, for example, by providing RF energy at a limited time or power level. In various embodiments, the condition can be triggered using a fixed threshold for any of these values ​​(e.g., 500 mA), and / or the threshold can be calculated during a sealing cycle (e.g., a 20% reduction from the expected maximum).

[0065] In various embodiments, the system of the present invention uses one or more of these thresholds to identify already sealed tissue and trigger it early in the sealing cycle. At the end of the sealing cycle, the initial activation and subsequent activations are very similar, and in both cases the tissue may be dry. However, at the beginning of the sealing cycle, the initial activation will draw more current or power (compared to subsequent sealings that are not) because water is still present in the tissue. In addition, the current or power drawn can change significantly when the tissue is sealed. Activations on already sealed tissue may have a much lower rate of change, and therefore the system of the present invention utilizes the differential value of the measured value of interest, which can be used to identify significant changes being made to the tissue.

[0066] In various embodiments, the system of the present invention tracks the phase of the RF output, particularly at the start of the sealing cycle, to identify repeated sealing and / or thin tissue. Double sealing tends to have a phase value greater than 20 degrees. Once a fragment of repeated sealing or thin tissue has been identified, an alternative RF path can be applied to that tissue.

[0067] In various embodiments, the system of the present invention uses a cascade of phase values ​​to adjust the RF output according to the magnitude of the initial phase. For example, when the phase is 20 to 25 degrees, a moderate reduction of RF energy is applied. However, when the phase is 25 to 30 degrees, the applied RF energy is further or more aggressively reduced so that it is more certain that the type of tissue is in contact with the instrument. Continuing this example, phase angles greater than 30 degrees result in the maximum or most aggressive reduction of RF energy.

[0068] When highly dry or thin tissue is identified, the heat applied by changing the RF output is reduced, resulting in a good tissue sealing effect. Adding or not adding RF energy to this type of tissue may result in additional heat diffusion, scabbing, adhesion, and / or longer procedure times without providing any further benefit to hemostasis.

[0069] In various embodiments, the electrosurgical system includes a double sealing system that uses a threshold to stop the voltage ramp, resulting in a lower holding voltage through sealing, and / or uses a threshold to terminate or pause the RF output, and / or end the sealing cycle. In various embodiments, the double sealing system may also use a threshold to result in a reduction of the total sealing time to immediately exit the state rather than reaching a timeout value.

[0070] Figure 10 shows exemplary RF energy control processes, scripts, or systems for electrosurgical generators and associated electrosurgical tools for dissolving or sealing tissue, according to various embodiments. In a first step 71, RF energy is supplied by the electrosurgical generator through the connected electrosurgical tool. In step 72, the electrosurgical generator sets the voltage of the supplied RF energy to generate RF energy with a steep ramp. In various embodiments, the supplied or generated RF energy is a steep ramp in which the voltage increases from a predetermined initial value (e.g., 40V) to a predetermined maximum value (e.g., 60V) over a predetermined period (e.g., 75ms), and / or the current increases from a predetermined initial value (e.g., 2500mA) to a predetermined maximum value (e.g., 5000mA) over the same predetermined period (e.g., 75ms). In step 73, the electrosurgical generator or system determines or identifies an RF output peak condition while continuing to supply RF energy in the ramp manner performed in step 72.

[0071] In various embodiments, the system of the present invention monitors or measures the current and / or power of the RF output to determine whether the current and / or power is decreasing or has reached a predetermined threshold. This is done to further determine whether a peak condition has been reached. If a peak condition is not identified or has not been reached, the system of the present invention determines in step 74 whether a double sealing condition exists. In various embodiments, the system of the present invention monitors or measures the current of the RF output to determine whether the current is decreasing or has reached a predetermined current threshold and whether a double sealing condition exists or can be identified. If a peak condition and / or double or repeat sealing is identified, the system of the present invention modifies or adjusts the RF output voltage to decrease in step 75. In various embodiments, the system of the present invention gradually ramps up the RF energy (in step 75), increasing it from a predetermined initial value (e.g., 35V) to a maximum value (e.g., 45V) over a predetermined period (e.g., 500ms).

[0072] In step 75 (above), the electrosurgical generator or system continues to supply RF energy in a ramp manner as described above, while in step 76, it monitors, determines, or identifies the holding conditions. In various embodiments, the electrosurgical generator or system measures, calculates, and / or monitors at least the phase, voltage, current, power, and / or the change / rate of change thereof of the supplied RF energy. In step 76, if the holding conditions (e.g., phase and current conditions) are reached, or if they are equal to, above, or below a predetermined threshold or value, the RF output is adjusted in step 77. In various embodiments, the electrosurgical generator maintains a constant voltage of the supplied RF output and / or terminates the ramp. In various embodiments, if the phase condition or threshold reaches or falls below a predetermined phase threshold, and the current condition or value reaches or falls below a predetermined current threshold, the electrosurgical generator adjusts the voltage of the supplied RF energy to be constant. If the phase and current conditions or thresholds are not reached or crossed, the electrosurgical generator continues to supply RF energy in a ramp manner (by step 75) and waits for a predetermined period while monitoring the holding conditions (by step 76). Under constant voltage conditions (by step 77), the electrosurgical generator monitors, identifies, or determines the termination conditions (by step 78) while continuing to supply and / or adjust the RF energy being supplied (in step 77). When the termination conditions are determined or identified, the process is considered complete. The termination procedure is initiated, and / or the RF energy supplied by the generator is stopped (in step 79). The process is considered complete when the power conditions or thresholds representing the termination conditions are reached, or equal to, above, or below a predetermined threshold or value. In this case, the termination procedure can be initiated, and / or the RF energy supplied by the generator can be stopped. If the termination conditions or thresholds are not reached or crossed, the electrosurgical generator continues to supply RF energy while monitoring the power conditions.

[0073] In various embodiments, impedance is measured before processing begins to determine short-circuit or open-circuit conditions by a low-voltage measurement signal sent to the connected electrosurgical tool. In one embodiment, passive impedance is measured to determine whether the captured tissue is within the operating range of the electrosurgical tool (e.g., 2–200 Ω). If the initial impedance check is passed, RF energy is supplied to the electrosurgical tool, and thereafter, impedance / resistance is not measured again or is ignored.

[0074] In various embodiments, the maximum current or power value is fixed or predetermined and stored in memory or provided or set via an external input. In various embodiments, the maximum current or power value is determined by the system of the present invention through the application of RF energy and monitoring the current and / or power of the supplied RF energy to determine the current or power peak. In various embodiments, the maximum current or power value represents the evaporation point of the tissue in contact with the electrosurgical instrument. In various embodiments, the generator provides a steep ramp of high voltage to quickly bring the tissue to the moisture evaporation point.

[0075] In various embodiments, the maximum phase value is determined by the system through the application of RF energy and monitoring the phase to determine a phase peak representing the RF output peak condition. In various embodiments, the device is provided with a thermocouple or similar temperature sensor or detection system, such as a thermocouple embedded in the jaw surface, to monitor the tissue temperature and potentially identify a rapid temperature rise that occurs until water evaporation begins, at which point the change in state stops the temperature rise due to the generation of water vapor with additional heat, and thus the RF output peak condition can be identified. In various embodiments, the minimum impedance is determined by the system of the present invention through the application of RF energy and monitoring the impedance of the tissue to determine an impedance bottom value representing the RF output peak bottom value. Thus, this process or system is somewhat reversed, determining a minimum value or minimum window rather than a maximum value.

[0076] In various embodiments, the electrosurgical generator applies a high-voltage ramp or pulse to rapidly bring the tissue to an RF output peak point or peak condition. In various embodiments, the RF output peak condition represents or corresponds to the water evaporation point or evaporation condition, for example, when the bodily fluids within the tissue change state and begin to evaporate. This can be observed when water vapor begins to be generated from the sealed tissue. In various embodiments, this point or condition is predetermined or identified when the power output or current output of the applied or supplied RF energy reaches its maximum or peak. If the evaporation point or peak point is not reached during a pulse (e.g., an underpulse), the subsequent voltage drop and gradual ramp-up are delayed in this sealing cycle. Underpulsed tissue starts its active sealing cycle or water removal much later than expected, resulting in a smaller total amount of water removed in the same amount of time.

[0077] In various embodiments, the electrosurgical generator is configured to provide additional adjustments to various parameters or functions associated with the output, voltage, current, power, and / or phase of the RF energy, and the actuarial engine is configured to adjust the output of the RF energy using the various parameters or functions. In one exemplary embodiment, the control circuit provides additional adjustment controls for direct phase adjustment, in which case the output of voltage, current, and / or power is adjusted to satisfy a specified phase adjustment setpoint given by the actuarial engine.

[0078] In various embodiments, the generator recognizes and acts / executes operating conditions using monitored, measured, and / or calculated values ​​of voltage, power, current, and / or phase (e.g., control indicators). In various embodiments, additional measurements, or calculations based on measurements associated with RF output adjustment circuits, are provided by a script or actuation engine to recognize and act on additional or different events associated with, or triggered by, the additional measurements, or calculations on other measurements or thresholds. Additional measurements in one embodiment include error signals combined with pulse-width modulation (PWM) load cycles used to adjust voltage, current, and / or power outputs, or other similar adjustment parameters. Different or additional events or indicators that can be identified or triggered in various embodiments may be transitions from one adjustment control to another (e.g., from current adjustment to power adjustment). In various embodiments, subsequent checks or measurements of impedance or temperature may not be performed because such checks or measurements may be inaccurate and / or impractical.

[0079] In various embodiments, the generator utilizes multiple states, control points, or checks to identify positive or negative trends in phase, current, or power values, respectively. An error is signaled if the electrosurgical generator fails to identify the expected trend. Multi-state checks increase or enhance the resolution of the electrosurgical generator in identifying expected RF output trends across different types of tissue.

[0080] In various embodiments, the electrosurgical generator also monitors the phase or current, and / or the rate of change of the phase or current, to determine whether the connected electrosurgical tool has experienced an electrical open-circuit or short-circuit condition. In one example, the electrosurgical generator identifies an electrical short-circuit condition in a connected electrosurgical instrument by monitoring the phase of the applied or supplied RF energy. An electrical short-circuit condition is identified when the monitored phase is greater than a predetermined maximum phase value. Similarly, in one example, the electrosurgical generator identifies an electrical open-circuit condition in a connected electrosurgical instrument by monitoring the current of the applied or supplied RF energy. An electrical open-circuit condition is identified when the monitored current is less than a predetermined minimum current. In either or both cases, the electrosurgical generator displays an error and stops the supplied RF energy when it detects an open-circuit and / or short-circuit condition.

[0081] In various embodiments, the predetermined processes described throughout this application are loaded into a memory module incorporated within a connector detachably connected to the connection portion and / or cable-type connection portion of an electrosurgical instrument. In various embodiments, the device script or process is programmed on an adapter PCBA (printed circuit board assembly) stored within the device connector or wired to the circuit within the device connector or controller during manufacturing / assembly. The script source file is written in a custom text-based language and compiled by a script compiler into a generator-only script database file. The script file contains parameters specially selected to configure the generator to output a specific voltage (e.g., 100V (RMS)), current (e.g., 5000mA (RMS)), and power level (e.g., 300VA). In various embodiments, a device key programmer device reads the script database file and then programs it into the memory of the adapter PCBA.

[0082] Now, moving to some of the operating modes of the electrosurgical tools or instruments described herein in various embodiments, the first jaws 31 and the second jaws 33 are positioned around the tissue with a blood vessel or tissue bundle identified for dissolution. When the movable handle 23 is tightened, the first jaws 31 and the second jaws 33 pivot together to substantially capture the tissue. The actuator 24 has a first or initial position, in which the jaws 22 are in an open position with the movable handle 23 positioned away from or spaced apart from the fixed housing 28.

[0083] When the surgeon presses the activation button 29, high-frequency energy is applied to the tissue between the jaw sections 22. With the tissue dissolved, the actuator 24 can be restarted by releasing the movable handle 23 and separating it from the fixed housing 28. To cut the tissue between the jaw sections 22, the user can activate the blade trigger 25. Moving the blade trigger proximal causes the cutting blade to move distally, dividing the tissue between the jaw sections 22. When the surgeon releases the blade trigger 25, the blade spring returns the cutting blade to its original position. In various embodiments, the actuator 24 has a cutting position in which the jaw sections 22 are in the closed position, the movable handle 23 is closed and latched, and the blade trigger 25 is pressed down to advance the cutting blade to its most distal position.

[0084] In various embodiments, there is an intermediate or un-latched position where the jaws 22 are closed or near closed, but the movable handle 23 is not latched. Therefore, when the movable handle 23 is released, it returns to its original or initial position. In one embodiment, the blade trigger 25 does not need to be activated to cut tissue between the jaws 22, but the activation button or switch 29 can be activated to dissolve tissue between the jaws 22. In various embodiments, there is a latched position where the jaws 22 are closed or near closed and the movable handle 23 is latched. Therefore, when the movable handle 23 is released, it does not return to its original or initial position. In one embodiment, the activation button or switch 29 can be activated to dissolve tissue between the closed jaws 22, and / or the blade trigger 25 can be activated to cut tissue between the jaws 22.

[0085] As described above, in various embodiments, the electrosurgical instrument has a first (open) state in which the jaws 22 are spaced apart from each other, and therefore the movable handle 23 is also spaced apart from the fixed housing 28. In this way, the electrosurgical instrument is positioned to capture tissue between the jaws 22. In a second (intermediate) state of the instrument, the jaws 22 are close together to capture tissue between them, and similarly, the movable handle 23 and the fixed housing 28 are also close together. The surgeon can return from the second state to the first state by opening the jaws 22 and thereby repositioning the jaws 22 to capture the tissue or other tissue. In a third (closed) state of the electrosurgical instrument, the movable handle 23 is brought closer to the fixed housing 28. In some embodiments, the movable handle 23 can be latched to the fixed housing 28. When moving to the third state, the tissue captured between the jaws 22 can be cut by activating the blade trigger 25. The movement of the movable handle 23 to a third state in which it is latched to the fixed housing 28 reduces the possibility of unintentional release of tissue. Similarly, it is possible to better avoid accidental cutting of tissue or cutting of tissue along the wrong tissue line. In addition, the third (closed) state allows for the application of a certain continuous, predetermined compression or a predetermined range of compression to the tissue between the jaws 22 before, during, and after the activation of the RF energy, thereby enhancing the sealing or dissolution of the tissue between the jaws 22. In various embodiments, the application of RF energy can occur immediately when the movable handle 23 and jaws 22 are in at least the second state and the surgeon activates the activation button 29. In some embodiments, the application of RF energy can occur immediately when the surgeon activates the activation button 29 while the movable handle 23 and jaws 22 are in the third state.

[0086] In various embodiments, it should be noted that, to avoid misreading, the electrosurgical generator does not measure the resistance or impedance of tissue while supplying RF energy to the tissue. Various embodiments provide an electrosurgical system that reduces thermal diffusion and provides efficient power delivery through a controlled and efficient supply of RF energy to seal blood vessels or tissues in contact with a bipolar electrosurgical instrument.

[0087] As described throughout this application, an electrosurgical generator supplies RF energy to a connected electrosurgical instrument. The electrosurgical generator ensures that the supplied RF energy does not exceed specified parameters and detects fault or error conditions. In various embodiments, the electrosurgical instrument provides commands or logic used to appropriately apply RF energy for a surgical procedure. For example, the electrosurgical instrument includes a memory having commands and parameters that instruct the operation of an instrument that works in conjunction with the electrosurgical generator. For example, the electrosurgical generator can supply RF energy, but the connected electrosurgical instrument determines the amount or duration of RF energy application. However, the electrosurgical generator does not allow the supply of RF energy to exceed a set threshold, even if indicated by the connected electrosurgical instrument, thereby providing suppression or assurance against erroneous instrument commands.

[0088] As generally described above and in more detail below, a variety of electrosurgical instruments, tools, or devices can be used in the electrosurgical systems described herein. For example, electrosurgical capture instruments, scissors, forceps, probes, needles, and other instruments incorporating one, some, or all of the embodiments described herein can provide various advantages in an electrosurgical system. Various embodiments and combinations thereof of electrosurgical instruments and generators are described throughout this application. One, some, or all of the features generally described throughout this application are intended to be included in any embodiment relating to the instruments, generators, and combinations thereof described herein. For example, each of the described instruments is preferably to include a memory for interacting with the generators described above, and vice versa. However, in another embodiment, the described instruments and / or generators may be configured to interact with a standard bipolar high-frequency power supply without interacting with instrument memory. In addition, for the sake of clarity, various embodiments can be described in terms of modules and / or blocks, which can be implemented by one or more hardware components, such as processors, digital signal processors (DSPs), programmable logic devices (PLDs), application-specific integrated circuits (ASICs), circuits, registers, and / or software components, such as programs, subroutines, logic, and / or combinations of hardware and software components. Similarly, such software components can be substituted for hardware components or combinations thereof, and vice versa.

[0089] Further examples relating to electrosurgical units, instruments, and connections thereto, and their operation and / or function are U.S. Patent Application No. 12 / 416,668, entitled “Electrosurgical System,” filed April 1, 2009; No. 12 / 416,751, entitled “Electrosurgical System,” filed April 1, 2009; No. 12 / 416,695, entitled “Electrosurgical System,” filed April 1, 2009; No. 12 / 416,765, entitled “Electrosurgical System,” filed April 1, 2009; No. 12 / 416,128, entitled “Electrosurgical System,” filed March 31, 2009; and No. 14 / 848,116, entitled “Electrosurgical System,” filed September 8, 2015, the entirety of these disclosures is incorporated by reference as if it were fully established herein. Certain aspects of these electrosurgical generators, tools, and systems are described herein, and additional details and examples relating to various embodiments are described in U.S. Provisional Patent Application No. 61 / 994,215, “Electrosurgical Dissolution Device,” filed May 16, 2014, No. 61 / 994,185, “Electrosurgical Generator with Synchronized Detector,” filed May 16, 2014, No. 61 / 994,415, “Electrosurgical System,” and No. 61 / 944,192, “Electrosurgical Generator,” filed May 16, 2014, and the entirety of these disclosures is incorporated by reference as if it were fully established herein.

[0090] The above description is provided to enable those skilled in the art to manufacture and use the surgical devices described herein and to perform the methods described herein, and enumerates the best modes of carrying out the invention as envisioned by the inventors. However, various modifications will be apparent to those skilled in the art. These modifications are considered to be within the scope of the disclosure of the invention. In addition, different embodiments or aspects of such embodiments can be shown in various figures and described throughout this specification. However, it should be noted that each embodiment and aspect thereof shown or described separately can be combined with one or more of the other embodiments and aspects thereof unless otherwise specified. Each combination is not explicitly described simply for the sake of readability of this specification. Likewise, the embodiments of the invention should be considered in all respects to be illustrative and not limiting. [Explanation of symbols]

[0091] 71. First stage where RF energy is supplied by the electrosurgical generator. 72. Step to set the voltage of the supplied RF energy. 74. The stage of determining whether or not a double sealing condition exists. 75. The step of changing or adjusting the RF output voltage to lower it. 76. A step in which the holding conditions are monitored, determined, or identified while RF energy is continuously supplied in a ramp manner.

Claims

1. A method for dissolving or sealing tissue, A step of applying a first amount of RF energy to a region of tissue, A step of determining the drying level of the area of ​​tissue affected by the step of applying the first amount of RF energy, A step of reducing the first amount of RF energy applied to the area of ​​the tissue based on the determined drying level to a second amount of RF energy, A step of increasing the amount of RF energy applied to the area of ​​tissue from a second amount to a third amount, wherein the ramp rate of the increasing amount of applied RF energy and the third amount of RF energy applied to the area of ​​tissue are based on the determined drying level, and the third amount is between the first amount of RF energy and the second amount of RF energy, A step of maintaining the third amount of RF energy applied to the area of ​​the organization for a first predetermined period of time, The step of ending the application of the RF energy to the area of ​​the tissue after the first predetermined period has elapsed, A method characterized by including the following.

2. The method according to claim 1, characterized in that the first amount of RF energy applied to the area of ​​the tissue has a low level of current or power.

3. The method according to claim 1, characterized in that the first amount of RF energy applied to the area of ​​the tissue has a high level of impedance.

4. The method according to claim 1, characterized in that the first amount of RF energy applied to the area of ​​the tissue has a low phase angle.

5. The method according to claim 1, characterized in that the first amount of RF energy applied to the area of ​​the organization has a low-energy output.

6. The method according to claim 1, characterized in that the step of determining the dryness level of the area of ​​tissue includes the step of identifying the current peak conditions of the RF energy applied to the area of ​​tissue.

7. The method according to 6, characterized in that the step of determining the dryness level of the area of ​​tissue further includes the step of identifying that the current peak condition of the RF energy applied to the area of ​​tissue is lower than a predetermined threshold.

8. The method according to 7, characterized in that the predetermined threshold corresponds to a double sealing condition.

9. The method according to 7, characterized in that the predetermined threshold corresponds to a repeat sealing condition.

10. The step of identifying the current peak condition is: A step of establishing an interruption value based on the maximum amount or a percentage of the window for the voltage or current that can be applied to the said area of ​​the organization, A step of detecting that the current voltage or current measurement is higher than the interruption value, including, The method according to feature 6.

11. The method according to 6, characterized in that the difference between the first amount of RF energy and the second amount of RF energy applied to the area of ​​the organization is based on the percentage used in the step of establishing the interruption value.

12. The method according to 11, characterized in that the amount for a higher percentage associated with the stage of establishing the interruption value is higher than a different amount corresponding to a lower percentage associated with the stage of establishing the interruption value.

13. The step of identifying the current peak condition is: A step of monitoring the rate of change of the current and / or power of the RF energy applied to the area of ​​the organization, The steps include comparing the monitored rate of change with a predetermined threshold corresponding to the identification that the current peak condition is about to occur or is likely to occur, including, The method according to feature 6.

14. The step of identifying the current peak condition is: A step of adjusting the current associated with the RF energy applied to the aforementioned area of ​​the organization, A step of detecting an increase in voltage above a predetermined threshold voltage, A step of associating the timing of the voltage increase, which is higher than the predetermined threshold voltage, with the current peak condition. including, The method according to feature 6.

15. The method according to claim 1, characterized in that the step of determining the dryness level of the area of ​​the tissue includes the step of identifying the amount of moisture evaporation during the sealing cycle.

16. The method according to 15, characterized in that the amount of water evaporation is identified through the discharge of water vapor.

17. The method according to claim 1, characterized in that the second amount of RF energy is based on a percentage associated with the expected maximum amount of RF energy that can be applied to the area of ​​tissue.

18. The method according to claim 1, characterized in that the second amount of RF energy is a preset value.

19. The method according to claim 1, characterized in that the step of determining the drying level includes a step of identifying a condition in which the area of ​​the tissue has already dissolved or sealed.

20. The method according to claim 1, characterized in that the step of determining the drying level includes the step of identifying the thickness of the area of ​​tissue.

21. The method according to claim 1, characterized in that the step of determining the drying level includes the step of identifying the volume of the area of ​​tissue.

22. The method according to 1, characterized in that the first amount of RF energy has a predetermined gradient voltage profile corresponding to a predetermined increase in the voltage of the RF energy over a second predetermined period.

23. The method according to 22, characterized in that the second predetermined period is based on the surface area of ​​the area of ​​the organization.

24. The method according to 22, wherein the second predetermined period includes a maximum time threshold that causes the increase in the RF energy voltage to terminate when the maximum time threshold is reached.

25. The method according to claim 1, characterized in that the first predetermined period associated with the step of maintaining the third amount of RF energy applied to the area of ​​tissue is based on the characteristics of the area of ​​tissue.

26. The method according to 20, characterized in that the characteristics of the area of ​​the tissue include the thickness or volume of the area of ​​the tissue.

27. The method according to claim 1, characterized in that the first amount of RF energy applied to the area of ​​tissue heats the area of ​​tissue to a predetermined temperature of 100°C to perform drying.

28. The method according to claim 1, characterized in that the third amount of RF energy applied to the area of ​​tissue maintains a temperature of the area of ​​tissue sufficient for continued drying.

29. The step of increasing the amount of RF energy applied to the area of ​​the organization from the second amount to the third amount is: A step of monitoring the phase and current of the RF energy when the voltage of the RF energy increases from a second amount, A step of detecting when the current drops and when the phase becomes capacitive, A step of identifying the third quantity based on when the detected current drop and capacitive phase occur, including, The method according to feature 1.

30. The method according to claim 1, characterized in that different drying levels are associated with different second and third amounts of RF energy applied to the area of ​​the tissue and different ramp rates of the RF energy from the second and third amounts.

31. An electrosurgical generator for dissolving or sealing tissue, Including the controller, The aforementioned controller, The RF amplifier is instructed to apply a first predetermined amount of RF energy to the area of ​​the organization. The drying level of the affected area of ​​the tissue is determined by applying the first predetermined amount of RF energy. Based on the determined drying level, the RF amplifier is instructed to reduce the first predetermined amount of RF energy applied to the area of ​​the tissue to a second amount of RF energy. The RF amplifier is instructed to increase the amount of RF energy applied to the area of ​​tissue from the second amount to the third amount, wherein the ramp rate of the increase in applied RF energy and the third amount of RF energy applied to the area of ​​tissue are based on the determined drying level, and the third amount is between the first amount of RF energy and the second amount of RF energy. The RF amplifier is instructed to maintain the third amount of RF energy applied to the area of ​​the organization, and After a first predetermined period has elapsed, the RF amplifier is instructed to terminate the application of the RF energy to the area of ​​the tissue. The aforementioned electrosurgical generator is An RF amplifier that generates a corresponding amount of RF energy that is passed to an electrosurgical instrument connected to an electrosurgical generator, wherein the generated corresponding amount of RF energy is based on the command provided by the controller, An electrosurgical generator characterized by further including the following:

32. The electrosurgical instrument includes a memory for storing scripts, The script is downloaded from the memory of the electrosurgical instrument to the controller. The script includes instructions to configure the electrosurgical generator to generate a predetermined amount of RF energy for the electrosurgical instrument. The electrosurgical generator according to feature 31.

33. It further includes a user interface for receiving user input, A command is generated instructing the electrosurgical generator to generate an amount of RF energy based on the user input. The electrosurgical generator according to feature 31.

34. The electrosurgical generator according to claim 31, characterized in that the first, second, and third amounts of RF energy generated by the RF amplifier are also based on the type of electrosurgical instrument connected to the electrosurgical generator.

35. The electrosurgical generator according to claim 22, characterized in that the first, second, and third amounts of RF energy generated by the RF amplifier are also based on the relevant surgical procedure being performed.

36. The first, second, and third amounts of RF energy generated by the RF amplifier are also based on the received user preference. The received user preferences are obtained through user input associated with the electrosurgical generator. The electrosurgical generator according to feature 22.

37. A method for dissolving or sealing tissue, The step of applying an initial amount of RF energy to a tissue area, A step of determining the drying level of the area of ​​tissue affected by the initial amount of RF energy, A step of changing the amount of RF energy continuously applied to the area of ​​the tissue based on the determined drying level over a predetermined period of time, A method characterized by including the following.

38. It is an electrosurgical generator, Including the controller, The aforementioned controller, The RF amplifier is instructed to apply an initial amount of RF energy to the area of ​​the tissue, Determine the drying level of the area of ​​tissue affected by the initial amount of RF energy, and The RF amplifier is instructed to change the amount of RF energy continuously applied to the area of ​​the tissue over a predetermined period of time based on the determined drying level. The aforementioned electrosurgical generator is An RF amplifier that generates a corresponding amount of RF energy based on the command provided by the controller, An electrosurgical generator characterized by further including the following:

39. A controller that determines the dryness level of an area of ​​the organization, An RF amplifier that generates a corresponding amount of RF energy based on the drying level determined by the controller, An electrosurgical generator characterized by including [a specific component].

40. It is a system, An electrosurgical generator that generates RF energy, An electrosurgical instrument for dissolving or sealing a tissue area, the electrosurgical instrument receiving RF energy from an electrosurgical generator to dissolve or seal the tissue area, Includes, The aforementioned electrosurgical generator is Determine the dryness level of the aforementioned area of ​​the organization, and A corresponding amount of RF energy is generated for the electrosurgical instrument and used to dissolve or seal the area of ​​tissue. A system characterized by the following features.

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