Electrosurgical occlusion and incision system
Bipolar electrosurgical instruments with optimized RF energy delivery and phase angle monitoring address the variability in tissue response, achieving precise and controlled melting and cutting with reduced thermal damage, enhancing surgical efficiency.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- APPL MEDICAL RESOURCES CORP
- Filing Date
- 2025-12-25
- Publication Date
- 2026-05-26
AI Technical Summary
Existing electrosurgical instruments, particularly bipolar types, face challenges in achieving consistent and controlled tissue melting and cutting outcomes due to reliance on surgeon skill and variability in tissue response to electrical energy application, which can lead to thermal damage and necrosis.
The development of bipolar electrosurgical instruments with specifically designed jaws and electrodes that utilize RF energy to simultaneously melt and cut tissue, monitored by a generator that adjusts energy delivery based on phase angle to optimize temperature and power, minimizing thermal spread and ensuring consistent tissue processing.
The solution enables precise and controlled tissue melting and cutting with reduced thermal damage, allowing for efficient surgical procedures with minimized instrument changes and improved surgical outcomes.
Smart Images

Figure 2026086397000001_ABST
Abstract
Description
Technical Field
[0001] The present invention generally relates to an electrosurgical (electrosurgery) system and method, and more particularly to an electrosurgical fusion / sealing (seal) / cutting system.
[0002]
Description of Related Applications
Background Art
[0003] Electrosurgical instruments that use electrical energy to perform certain surgical tasks have become available. Typically, an electrosurgical instrument is a surgical instrument, such as a grasper, scissors, forceps, blade, or needle, that includes one or more electrodes configured to be supplied with electrical energy from an electrosurgical unit that includes a power source. The electrical energy can be used to coagulate, melt, or cut tissue to which the electrical energy is applied.
[0004] Electrosurgical instruments typically belong to two main classifications: monopolar and bipolar. In monopolar instruments, electrical energy is supplied at a high current density to one or more electrodes of the instrument, and a separate return electrode is electrically coupled to the patient. This return electrode is often designed to minimize the current density. While monopolar electrosurgical instruments may be useful in certain procedures, they can pose a risk of trauma to certain types of patients, such as electrical burns, often due to the function of the return electrode, at least partially. In bipolar electrosurgical instruments, one or more electrodes are electrically coupled to an electrical energy source of a first polarity, and one or more other electrodes are electrically coupled to an electrical energy source of a second polarity opposite to the first. Bipolar electrosurgical instruments that operate without a separate return electrode can deliver concentrated electrical signals to tissue areas with reduced risk.
[0005] However, even when the surgical effect of bipolar electrosurgical instruments is relatively concentrated, surgical outcomes often depend heavily on the surgeon's skill. For example, if electrical energy is delivered for a relatively long period of time, or if a relatively high-power electrical signal is delivered for a short period, thermal tissue damage and necrosis may occur. The rate at which tissue achieves the desired coagulation or cutting effect when electrical energy is applied varies depending on the type of tissue and can also vary based on the pressure applied to the tissue by the electrosurgical instrument. However, it can be difficult for a surgeon to assess how quickly they can melt a desired amount of a combined tissue mass held by an electrosurgical instrument. [Overview of the project] [Problems that the invention aims to solve]
[0006] According to various embodiments, electrosurgical laparoscopic melting / sealing and cutting instruments are provided that are configured to melt and cut tissue simultaneously. In various embodiments, the electrosurgical instrument or device has a first jaw and a second jaw that is opposite to the first jaw and grasps tissue between the first jaw and the second jaw. The first jaw has an electrode, and the second jaw has an electrode. The electrodes of the first and second jaws are arranged to melt and cut the tissue between the first and second jaws using high-frequency energy, with no electrodes in the central portions of the first and second jaws that face each other.
[0007] In various embodiments, the electrosurgical instrument includes a first jaw having a first electrode having a first surface area in contact with tissue and a second electrode having a second surface area in contact with tissue. The first surface area is equal to the second surface area. The instrument further includes a second jaw that is opposite to the first jaw and coupled to the first jaw to grasp tissue between itself and the first jaw. The second jaw has a third electrode having a third surface area in contact with tissue and a fourth electrode having a fourth surface area in contact with tissue. The third surface area is equal to the fourth surface area, and the fourth surface area is greater than the first surface area. The first and third electrodes are positioned to melt tissue located between the first and second jaws using high-frequency energy on one side of the longitudinal axis, and the second and fourth electrodes are positioned to melt tissue located between the first and second jaws using high-frequency energy on the opposite side of the longitudinal axis.
[0008] According to various embodiments, an electrosurgical system is provided that simultaneously melts and cuts tissue. In various embodiments, the system includes an electrosurgical generator and an electrosurgical melting / sealing and cutting instrument or device. The generator has an RF amplifier and a control device. The RF amplifier supplies RF energy via a detachably coupled electrosurgical instrument, such as an electrosurgical melting and cutting instrument, configured to melt and cut tissue using only RF energy. The control device is configured to monitor the phase angle of the supplied RF energy, and if the monitored phase angle is greater than zero and increasing, the control device sends a signal to the RF amplifier to increase the voltage of the supplied RF energy. In various embodiments, if the monitored phase angle is decreasing, the control device sends a signal to the RF amplifier to stop the supplied RF energy.
[0009] Many of the accompanying features of the present invention will be readily apparent when the present invention is viewed in conjunction with the accompanying drawings and the above and following descriptions.
[0010] The present invention will be best understood when described in conjunction with the accompanying drawings, in which reference numerals indicate the same parts throughout the drawings. [Brief explanation of the drawing]
[0011] [Figure 1] This is a perspective view of an electrosurgical system according to various embodiments of the present invention. [Figure 2] This is a perspective view of an electrosurgical generator as one of various embodiments of the present invention. [Figure 3] This is a perspective view of an electrosurgical instrument as various embodiments of the present invention. [Figure 4] This is a perspective view of the distal end of an electrosurgical instrument as one of various embodiments of the present invention. [Figure 5] This is a perspective view of the distal end of an electrosurgical instrument as one of various embodiments of the present invention. [Figure 6]This is a perspective view of the distal end of an electrosurgical instrument as one of various embodiments of the present invention. [Figure 7] This is a perspective view of the distal end of an electrosurgical instrument as one of various embodiments of the present invention. [Figure 8] This is a perspective view of the distal end of an electrosurgical instrument as one of various embodiments of the present invention. [Figure 9] This is a perspective view of the distal end of an electrosurgical instrument as one of various embodiments of the present invention. [Figure 10] This is a perspective view of the distal end of an electrosurgical instrument as one of various embodiments of the present invention. [Figure 11] This is a graph showing sample experimental data related to melting and cutting processes using electrosurgical instruments as various embodiments of the present invention. [Figure 12] This is a graph showing sample experimental data related to melting and cutting processes using electrosurgical instruments as various embodiments of the present invention. [Figure 13] This is a graph showing sample experimental data related to melting and cutting processes using electrosurgical instruments as various embodiments of the present invention. [Figure 14] This is a cross-sectional view of the distal end of an electrosurgical instrument as one of various embodiments of the present invention. [Figure 15] This is a flowchart illustrating the operation of an electrosurgical system as one of various embodiments of the present invention. [Figure 16] This is a schematic block diagram of several parts of an electrosurgical system as various embodiments of the present invention. [Figure 17] This is a schematic block diagram of several parts of an electrosurgical system as various embodiments of the present invention. [Figure 18] This is a schematic block diagram of several parts of an electrosurgical system as various embodiments of the present invention. [Figure 19] This is a flowchart illustrating the operation of an electrosurgical system as one of various embodiments of the present invention. [Figure 20] This is a flowchart illustrating the operation of an electrosurgical system as one of various embodiments of the present invention. [Figure 21] A flowchart showing the operation of an electrosurgical system according to various embodiments of the present invention. [Figure 22] A graph of a sample of experimental data related to an electrosurgical instrument according to various embodiments of the present invention. [Figure 23] A graph of a sample of experimental data related to an electrosurgical instrument according to various embodiments of the present invention. [Figure 24] A graph of a sample of experimental data related to an electrosurgical instrument according to various embodiments of the present invention.
Mode for Carrying Out the Invention
[0012] Generally, bipolar electrosurgical melting / sealing and cutting type instruments, devices or tools are provided, which are configured to simultaneously melt and cut tissue captured between the jaws of the instrument. The jaws have electrodes that are individually positioned, shaped and directed together with a compressible landing pad to simultaneously melt and cut tissue. The bipolar surgical melting and cutting instrument may also separately melt or cut tissue. Cutting of tissue in various embodiments is performed, in particular, without the use of a mechanical cutting blade, using a specific or central cutting electrode or without the shearing force or action of scissors. The instrument in various embodiments is provided to be used in laparoscopic surgery with a maximum diameter of 5 mm and thus can be inserted through a 5 mm trocar.
[0013] In addition, generally speaking, an electrosurgical system is provided that includes an electrosurgical generator and a removably coupled electrosurgical instrument, such as a melting and cutting instrument, and such an electrosurgical generator and electrosurgical instrument are configured to optimally melt and cut tissue. RF energy is supplied by an electrosurgical generator, which is configured to provide appropriate RF energy to melt and cut tissue. As various embodiments, the generator determines the appropriate RF energy and appropriate method of delivering this RF energy for a particular connected electrosurgical instrument, the specific tissue in contact with the instrument, and / or a particular surgical procedure. Operationally, RF sealing or melting of tissue between jaws is performed to reduce sealing time, output voltage, output power, and / or thermal spread. Therefore, the effective and consistent delivery of power to the tissue is performed to heat the tissue within a certain temperature range at a specific rate that has been found to be optimal for the effect on the tissue.
[0014] Referring to Figures 1 and 2, an exemplary embodiment of an electrosurgical system is shown, which includes an electrosurgical generator 10 and a detachably connectable electrosurgical instrument 20. The electrosurgical instrument 20 is preferably electrically coupled to the generator via a cable connection 30 to a tool or instrument port 12 provided on the generator. The electrosurgical instrument 20 is preferably provided with auditory, tactile, and / or visual indicators to inform the user of a specific predetermined state of the instrument, such as the start and / or end of a melting or cutting operation. In other embodiments, the electrosurgical instrument 20 is preferably reusable and / or connectable to another electrosurgical generator for another surgical procedure. In some embodiments, a manual control device, such as a hand or foot switch, is preferably connectable to the generator and / or instrument to enable predetermined selective control of the instrument, for example, to initiate a melting or cutting operation.
[0015] According to 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 generator. In one embodiment, the generator 10 outputs RF energy (150V and 5A at 375VA, 350kHz), and in one embodiment, it is configured to calculate the phase angle or difference between the RF output voltage and the RF output current while operating or supplying RF energy. The generator 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 generator 10 stops the RF energy output under predetermined conditions, for example, when an instrument switch is deasserted (e.g., when a fuse button is released), when a time value is met and / or when the active phase angle and / or phase change exceeds a certain phase and / or phase stop value.
[0016] The electrosurgical generator 10 has two novel bipolar tool ports 12, a standard bipolar tool port 16, and a power port 14. In other embodiments, the electrosurgical unit may have a different number of ports. For example, in some embodiments, the electrosurgical generator may have three or more or one or fewer novel bipolar tool ports, two or more or zero standard bipolar tool ports, and two or more or zero power ports. In one embodiment, the electrosurgical generator has only two novel bipolar tool ports.
[0017] According to various embodiments, each new bipolar tool port 12 is configured to be coupled to an electrosurgical instrument equipped with a mounted or integrated memory module. A standard bipolar tool port 16 is configured to accept a non-specific type of bipolar electrosurgical tool, different from the new bipolar electrosurgical instruments that can be connected to the new bipolar tool port 12. The power port 14 is configured to accept or connect to a DC accessory device distinct from non-specific bipolar electrosurgical tools and novel electrosurgical instruments. The power port 14 is configured to supply a DC voltage. For example, in some embodiments, the power port 14 can provide about 12 volts DC. The power port 14 is preferably configured to power surgical accessories, such as ventilators, pumps, lights, or other surgical accessories. Thus, in addition to replacing electrosurgical generators for standard or non-specific bipolar tools, electrosurgical generators can replace power supplies for surgical accessories. In some embodiments, replacing existing generators and power supplies with electrosurgical generators can reduce the amount of storage space required on storage racks, cards, or shelves for many trunk cords needed in a surgical or operating workspace.
[0018] In one embodiment, the generator does not actively check the tool when a non-specific bipolar tool is coupled to a standard bipolar port. However, the generator recognizes the connection so that it can display information about the non-specific bipolar tool. According to various embodiments, the generator recognizes the instrument connection status for each of the new tool ports 12, authenticates the connected instrument, and then receives RF energy activation requests (e.g., activation of instrument switches, e.g., fuse buttons). In one embodiment, the generator reads authenticated data from the connected instrument and also reads electrical control values (e.g., voltage level setting, current level setting, power level setting, active phase angle level setting, RF energy output activation timing limit, instrument short-circuit limit, instrument open-circuit limit, instrument model / identification, RF energy output line configuration, switch state command configuration, and / or combinations thereof) from the authenticated and connected instrument.
[0019] In various embodiments, the electrosurgical generator 10 may have a display 15. The display may be configured to indicate the status of the electrosurgical system, such status may include, among other things, the status of one or more electrosurgical instruments and / or accessories, connectors or connections thereto. In some embodiments, the display may consist of a multiline display, such as an LCD panel display, which can provide text and graphic information, and in some embodiments, such an LCD panel display may be illuminated via a backlight or sidelight. In some embodiments, the display may consist of a multicolor display, which may be configured to display information about specific instruments electrically coupled to the electrosurgical generator and colors corresponding to specific surgical procedures (e.g., cutting operations indicated by yellow text and graphics, melting or welding operations indicated by purple, and coagulation operations indicated by blue, and bloodless dissection operations which may be indicated by yellow and blue).
[0020] In some embodiments, the display is preferably configured to simultaneously display status data for multiple instruments, which are divided to display status information for each instrument electrically coupled to and / or connected in correspondence to the tool port. Visual indicators, such as status bar graphs, can be used to illustrate the proportion of total available electrical energy to be applied to a bipolar electrosurgical instrument during operation. In various embodiments, an electrosurgical instrument capable of cutting, sealing, coagulating, or melting tissue may have three color displays or bar graphs. In some embodiments, the user can switch the display between providing the status of multiple electrically connected instruments and providing the status of a single electrically connected instrument. According to various embodiments, once instruments and / or accessories are connected and / or detected, a window on the user interface display opens to show the instrument connection type and status.
[0021] The electrosurgical generator may, according to various embodiments, have a user interface, for example, a number of buttons 17. These buttons enable user interaction with the electrosurgical generator, allowing, for example, requests to increase or decrease the electrical energy supplied to one or more instruments coupled to the electrosurgical generator. In other embodiments, the display 15 may be a touchscreen display, thus incorporating data display and user interface functions. According to various embodiments, the surgeon can set the voltage setting value by selecting one to three levels via the user interface. For example, at level 1, the voltage is set to 110V; at level 2, the voltage is set to 100V; and at level 3, the voltage is set to 90V. For all three levels, the voltage is set to 5 amperes and the power is set to 300 VA. In other embodiments, the voltage is preset to a specific level, for example, level 2, or this is the default. In other embodiments, the voltage setting, like the current and power setting, is not user-adjustable to simplify the operation of the generator; therefore, a predetermined default voltage setting is used, for example, with the voltage set to 100V.
[0022] In one embodiment, the electrosurgical tool or instrument 20 may further have one or more memory modules. In some embodiments, the memory may include operational data relating to this instrument and / or other instruments. For example, in some embodiments, the operational data may include information regarding electrode configuration / reconfiguration, instrument usage, operating time, voltage, power, phase and / or current setting values, and / or information relating to specific operating states, conditions, scripts, processes or procedures. In one embodiment, the generator initiates reading from and / or writing to the memory modules.
[0023] In one embodiment, each new bipolar electrosurgical instrument is accompanied by a memory module and / or integrated circuitry that provides instrument authentication, configuration, expiration, and logging. The instrument verification and authentication process is initiated by coupling such instrument into a receptacle or port. Instrument authentication is provided, in one embodiment, via a challenge-response scheme and / or via a stored secret key also shared by the generator. Other parameters have a hash key for integrity checks. Usage is logged in the generator and / or instrument integrated circuitry and / or memory. In one embodiment, unlogged usage may occur as a result of errors. In one embodiment, the logging is set in binary and interpreted offline by the instrument or via the generator.
[0024] In one embodiment, the generator monitors the expiration of the instrument using a time measurement component. Such a component utilizes a polling oscillator, timer, or real-time calendar clock configured with the boot time. Timer interrupts are handled by the generator and can be used by a script for timeout events. Logging also displays logged events with their timestamps using a timer or counter.
[0025] According to various embodiments, the generator provides the ability to read the phase difference between the voltage and current of RF energy transmitted through a connected electrosurgical instrument while the RF energy is active. While the tissue is being melted, the phase reading is used to detect different states during the melting or sealing and cutting processes.
[0026] In one embodiment, the generator logs usage details in a downloadable internal log. The generator has memory for storing code and instrument performance. The generator has programmable memory containing instructions for specific instrument performance. The memory holds, for example, the serial number and instrument usage parameters. The generator stores information about the type of connected instrument. Such information includes, but is not limited to, the instrument identifier, such as the serial number of the connected instrument, the number of times the connected instrument has been used or the duration of use, and changes made to the power setting and default setting of each instrument. In one embodiment, the memory holds data for about two months, about 10,000 instrument uses or up to 150 logged startups, and this memory is configured to overwrite itself as needed.
[0027] According to various embodiments, the generator does not monitor or control current, power, or impedance. The generator can adjust and match voltage. The electrosurgical power delivered is a function of the applied voltage, current, and tissue impedance. A generator can influence the electrosurgical power being delivered through voltage regulation. However, increasing or decreasing the voltage does not necessarily increase or decrease the delivered electrosurgical power. Power reactions are caused not by the power-supplying generator, but by the power or tissue state interacting with the tissue in the absence of any control from the generator.
[0028] Once the generator starts supplying electrosurgical power, it does so continuously, for example, every 150 ms, until a failure occurs or a specific phase parameter is reached. In one embodiment, the jaws of the electrosurgical instrument are opened, so that the pressure can be released before, during, and at any point after the application of electrosurgical power. In another embodiment, the generator does not interrupt or wait for a specific duration or a predetermined time delay to initiate the cessation of electrosurgical energy.
[0029] Referring to Figures 3 to 14, various embodiments provide a bipolar melting and cutting electrosurgical instrument 20. In the illustrated embodiments, the instrument 20 has an actuator 24 coupled to an elongated rotatable shaft 26. The elongated shaft 26 has a proximal end and a distal end, with a central longitudinal axis defined between the distal and proximal ends. A jaw 22 is provided at the distal end of the shaft 26, and an actuator is provided at the proximal end. In one embodiment, the actuator is a handle resembling the grip of a pistol. In one embodiment, the shaft 26 and jaw 22 are dimensioned and shaped to fit into a 5 mm diameter trocar cannula or access port.
[0030] The actuator 24 has a movable handle 23 and a stationary handle or housing 28, the movable handle 23 being able to move relative to the stationary housing while coupled to it. According to various embodiments, the movable handle 23 is slidably and rotatably coupled to the stationary housing. In operation, a user, such as a surgeon, operates the movable handle 23 to activate the jaws, for example, to selectively open or close the jaws. According to various embodiments, the actuator 24 has a force adjustment mechanism configured, in the closed position, to cause the jaws 22 to deliver a gripping force between a predetermined minimum force and a predetermined maximum force.
[0031] As part of the force adjustment mechanism, the movable handle 23 is coupled to the stationary handle at two sliding pivot locations to form the force adjustment mechanism. The movable handle has a first end on which a gripping surface is formed and a second end opposite to the first end. The movable handle is coupled to a pin provided adjacent to the second end. In some embodiments, the movable handle is preferably formed integrally with a projection extending from the movable handle to constitute the pin surface. In other embodiments, the pin is preferably pressure-fitted into a hole provided in the movable handle. The pin is preferably housed in a slot provided in the stationary housing, for example, corresponding slots formed in the right and / or left handle frames of the stationary housing. In some embodiments, the slots are preferably configured to define a desired operating handle path, for example, a curved or V-shaped path, when the operating handle is moved from a first position corresponding to an open jaw to a second position corresponding to a closed jaw. The force adjustment mechanism includes a biasing member, for example, a tension spring, that biases the pin in the proximal direction. To describe the operation, when a predetermined force is applied by the movement of the movable handle, it overcomes the biasing force applied by the spring, and the second end of the movable handle can be translated distally as a whole, guided by the pin in the slot.
[0032] According to various embodiments, the movable handle is slidably and rotatably coupled to the stationary housing 28 at a location between the first and second ends of the operating handle. An actuator component, such as a pull block, is coupled to the operating handle. When the movable handle is moved proximal, the pull block also moves proximal and longitudinally, closing the jaws 22 and thereby clamping any tissue between the jaws. The pull block is rectangular in shape, according to various embodiments, having open top and bottom faces and a closed proximal end. A movable handle penetrates the top and bottom faces of the pull block. The edge of the movable handle contacts the proximal end of the pull block so that the pull block moves longitudinally as a result of the movement of the movable handle relative to the stationary housing. In one embodiment, the distal end of the pull block is coupled to an operating shaft, such as a pull tube, bar, or rod, which preferably extends longitudinally along an elongated shaft 26. Thus, to describe the operation, the movement of the movable handle from a first position to a second position causes the pull block to translate longitudinally within the stationary housing, thereby causing the pull tube to translate linearly as a whole along its longitudinal axis relative to the elongated shaft 26. This movement of the pull tube can control the relative movement of the jaws 22.
[0033] According to various embodiments, the actuator 24 has a latch mechanism that positions the movable handle 23 in a second position relative to the stationary housing 28. In various embodiments, the movable handle has a latch arm which engages with a paired mating latch housed within the stationary handle to hold the movable handle in the second or closed position. In various embodiments, the actuator has a wire harness containing individual insulated wires or leads housed within a single sheath. The wire harness can exit the stationary housing at its underside and form part of a cable connection. The wires within the harness can provide electrical communication between the instrument and the electrosurgical generator and / or its accessories or attachments.
[0034] According to various embodiments, the actuator has one or more leads attached to a rotary coupling clip configured to allow infinite rotation of the shaft. In various embodiments, a switch is connected to a user-operated activation button 29, which is activated when the activation button is pressed. In one view, once activated, the switch forms a circuit by electrically coupling at least two leads to each other. Thus, an electrical path is then established from the electrosurgical generator to the actuator to supply RF energy to the leads attached to the rotary coupling clip.
[0035] In one embodiment, the actuator has a rotating shaft assembly including a rotating knob 27 mounted on an outer cover tube of an elongated shaft 26. The rotating knob allows the surgeon to rotate the shaft of an instrument while gripping the actuator 24. According to various embodiments, the elongated shaft 26 has an actuation tube that connects jaws 22 to the actuator. In various embodiments, the actuation tube is housed within an outer cover tube. The actuation tube is shown as a tubular member as a whole that can be fitted into the outer cover tube, but in other embodiments, non-tubular actuation members, such as a shaft, a rigid band, etc., may be used, and in certain embodiments, this actuation member may be located within the outer cover tube.
[0036] According to various embodiments, a rotating shaft assembly is attached to the distal end of the outer cover tube, and this rotating shaft assembly includes two paired hubs and a conductive sleeve. The hubs snap into place with each other and engage with the outer cover tube. In other embodiments, the hubs may be of a single, integrated structure, and may be configured to interface with paired features provided on the outer cover tube. The conductive sleeve may be attached to the proximal portion of the assembled hub after the assembled hub has been attached to the outer cover tube. When the conductive sleeve is attached to the rear of the assembled hub, the sleeve captures the exposed end of the insulated wire. In the illustrated embodiment, the insulated wire extends from its capture point located below the conductive sleeve through a slot provided in the operating tube and then into a protective sleeve. The protective sleeve and the insulated wire extend distally within the operating tube toward the jaws. In other embodiments, the insulated wire may be formed integrally with the protective sheath, in which case there is no separate protective sleeve within the operating tube.
[0037] A jaw 22 is attached to the distal end of an elongated shaft, and the jaw 22 consists of a first jaw 70 and a second jaw 80. In one embodiment, a jaw pivot pin rotatably connects the first jaw and the second jaw, and such a jaw pivot pin allows the first jaw to move and rotate relative to the second jaw. In various embodiments, one jaw is fixed to the elongated shaft, and the opposing jaw rotates between an open position and a closed position relative to the fixed jaw. In other embodiments, both jaws are preferably rotatably connected to the elongated shaft, so that both jaws can rotate relative to each other.
[0038] The geometric shape of the jaws provides a specific pressure profile and current density at specific locations to produce the required melting / sealing and cutting effects. Operationally, the temperature required to achieve sealing and splitting is minimized, while protein cross-linking within the vascular structure is maximized, thereby maximizing the melting / sealing and splitting effect of the tissue.
[0039] According to various embodiments, the phase angle and / or the rate of change of the phase angle are monitored to monitor the temperature of the biological reaction. The phase angle has been found to provide an indicator of the temperature of the biological reaction and to indicate that tissue splitting has occurred. According to various embodiments, the electrosurgical instrument uses bipolar RF energy for electrosurgery to cut and melt tissue located between the jaws during opening and closing and / or in contact with the lower jaw when the jaws are opened and closed. In one embodiment, the temperature of the tissue is monitored during the sealing and / or splitting cycle.
[0040] Novel bipolar electrosurgical instruments, in various embodiments, utilize bipolar RF energy for both tissue sealing or melting and division or cutting. Therefore, while applying the energy required for tissue division, the instrument maintains the cellular structure of the tissue adjacent to the division area. Other RF dissection instruments use localized arcing or spark gaps to achieve dissection by vaporizing the tissue. This may be acceptable for straight tissue dissections. This is because the surrounding area is not sealed or melted, and therefore differs from melting and cutting instruments and systems as various embodiments of the present invention.
[0041] Novel bipolar electrosurgical instruments in various embodiments also take into account the high heat associated with tissue evaporation or tissue incision. Therefore, in various embodiments, these instruments utilize temperature control to minimize the energy required to achieve tissue division. By minimizing the required energy, the temperature during the reaction is lower, reducing the risk of cellular structures being damaged due to high energy output.
[0042] Maintaining the cellular structure of the working tissue requires that sealing occur adjacent to the incision area, which is necessary when fusion and incision or division are performed simultaneously. Furthermore, the addition of open cutting and sealing modes reduces the number of instruments used or the frequency of instrument changes during surgical procedures, or allows all such functions of individual instruments to be incorporated into a single new type of bipolar laparoscopic instrument.
[0043] In various embodiments, the electrosurgical instrument has movable jaws, which can trap tissue between them. In one embodiment, the jaws include at least one upper jaw, which closes over a stationary lower jaw. According to various embodiments, the upper jaw has a rigid upper jaw member 41, an upper conductive pad 42, a rigid insulating pad 43, a wire 44, and a compressible landing pad 45, all of which are joined together using an insert molding method, and the upper jaw is thus provided as a single structure or assembly as shown in Figure 6.
[0044] The rigid upper jaw member and the upper conductive pad are both active electrodes with opposite properties to each other. The compressible landing pad provides a surface with a specific spring constant to ensure that contact and pressure occur between the landing pad and the length of the lower jaw. The upper conductive pad 42 is electrically insulated from the rigid upper jaw member 41 by the landing pad 45 and the insulating pad 43. In various embodiments, the upper jaw is made of stainless steel and has higher rigidity than the landing pad 45. In various embodiments, the landing pad 45 is made of silicone and has higher responsiveness than the upper jaw member 41 or the conductive pad 42. In various embodiments, the insulating pad is made of a non-conductive material and has the same or higher rigidity as the upper jaw member 41 or the conductive pad 42. In various embodiments, the upper jaw member 41 and the conductive pad are made of the same material.
[0045] The upper jaw member 41 and the conductive pad have lower outer surfaces positioned to be in contact with the tissue. These lower surfaces are angled or inclined, and are mirror images of each other; such positioning or orientation facilitates the concentration of current density and the fixation of tissue. The compressible landing pad 45 has a lower surface positioned to be in contact with the tissue and / or the lower jaw. In the illustrated embodiment, the landing pad is flat and not parallel to the inclined lower surfaces of the upper jaw member and the conductive pad 42. The positioning and orientation of the lower surface of the landing pad assists in the concentration of current density, assists in the fixation of tissue, and facilitates the electrical dissection of tissue. The spring constant of the landing pad is predetermined in various embodiments to produce an optimal pressure or force to cause or facilitate the electrical dissection of tissue.
[0046] The lower jaw comprises a rigid lower jaw member 52, a lower conductive pad 53, a cutting electrode 55, two rigid insulators 54, 56, and two wires in total, one leading to the conductive pad and one leading to the cutting electrode, all of which are joined to each other using an insert molding method, and thus provided as a single structure or assembly as shown in Figure 7 according to various embodiments of the present invention. The rigid lower jaw member 52, the lower conductive pad 53, and the cutting electrode 55 are all active electrodes or act as active electrodes. The lower conductive pad 53 and the cutting electrode 55 have the same polarity and are electrically insulated from the rigid lower jaw member having opposite polarity by the two rigid insulators 54, 56.
[0047] The lower jaw member 52 and the conductive pad 53 have upper outer surfaces positioned to be in contact with the tissue. These upper surfaces are angled or inclined and mirror images of each other, and such positioning or orientation facilitates the concentration of current density and the fixation of the tissue. In various embodiments, the lower jaw is made of stainless steel and has a rigidity approximately the same as that of the conductive pad 53, or a higher rigidity than that of the conductive pad 53. In various embodiments, the rigid insulators 54 and 56 are made of a non-conductive material and have a rigidity similar to or greater than that of the lower jaw member 52 or the conductive pad 53. In various embodiments, the lower jaw member 52 and the conductive pad 53 are made of the same material.
[0048] Figure 8 shows cross-sectional views of the overall jaw structure as various embodiments, demonstrating the interaction of the geometric properties of the upper and lower jaws (e.g., shape, dimensions, material, and any combination thereof for optimal melting and cutting). To explain the operation, the conductive pads 42 and 53 are of the same polarity. The upper and lower jaw members 41, 51, and 52 are of the same polarity, but opposite to that of the conductive pads 42 and 53. In one embodiment, the cutting electrode 55 is active only during open cutting and melting operations, and this cutting electrode is opposite to that of the lower jaw member 52. As shown in the figure, the landing pad 45 obstructs and presses against the lower jaw member 52 and the conductive pad 53 when the jaws close. Any tissue (not shown) trapped between the lower jaw and the upper jaw is also compressed between the landing pad 45, the lower jaw member 52, and the conductive pad 53.
[0049] The polarity of each electrode is set to generate appropriate RF energy and heating due to the current flowing between these electrodes. As shown in Figure 9, the direction of current flow takes into account heating between the conductive pad and the jaw member, as illustrated by arrow 101, as well as heating from end to end on the lower jaw structure. The end-to-end heating on the lower jaw structure is performed for tissue separation, as illustrated by arrow 102. To separate the tissue below the middle of the jaw, the tissue is heated to a temperature of 60°C to 100°C to denature the collagen present in the tissue. Once the collagen is denatured, it becomes gelatinous.
[0050] When the tissue is in a gelatinous or crystalline state, the spring constant and interference of the silicone landing pad cause mechanical separation of the tissue, as illustrated by arrow 103 in Figure 10. In various embodiments, the spring constant is predetermined to optimize tissue separation by interference to the pad and lower jaw, so that the landing pad compresses by a predetermined distance or amount to fit the tissue between the pad and the lower jaw with minimal or no impact on adjacent tissue. Therefore, the electrode configuration takes into account the simultaneous heating of the sealing region (the region between the conductive pad and the jaw member) and the cutting region (the current region from end to end on the lower jaw). Collagen denaturation is also a mechanism used to cause tissue sealing or melting. Sealing utilizes the same temperature as cutting (60°C to 100°C), but the jaw seal gap between the conductive pad and the jaw member creates a mold for the seal to re-crosslink once the RF application is complete. As can be seen, by rapidly reaching high temperatures, cellular structures may break down due to the rapid heating of intercellular water. Therefore, the gradual increase in temperature and the long residence time within a suitable temperature range take into account the complete denaturation of collagen.
[0051] In various embodiments, the phase angle and / or rate of change of the phase angle of the tissue are monitored to achieve an appropriate temperature for the tissue and produce an effect on the relevant tissue, such as a gradual increase and / or a long residence time. Figures 11 to 13 are illustrative graphs of sealing and splitting cycles according to various embodiments. Also, as shown, the phase 111g is shown relative to other tissue readings or indicators, such as voltage 111a, power 111b, impedance 111c, energy 111d, temperature 111e, and current 111f. In addition, as shown in Figures 11 to 13, in various embodiments, the generator is configured not to measure or calculate one or more of the indicators or readings, such as temperature or energy, in order to reduce operating costs and power costs, as well as power consumption and / or the number of components of the generator. Additional information or readings are generally provided or shown for relevant purposes.
[0052] As shown in Figures 11-13, the temperature of the tissue 111e between the jaws increases from the start of the RF energy up to the point of the highest phase angle. At this point of the highest phase angle (or the inflection point of the rate of change of the phase angle) 155, even if the voltage decreases, a temperature plateau 150 is momentarily maintained (approximately 0.75 seconds), followed by a higher state 152.
[0053] One notable consequence of the behavior of the temperature profile is that instantaneous temperature flats may be due to changes in the state of water or moisture present in the tissue. Once water begins to boil, the temperature does not increase until the liquid water turns into steam. Therefore, the calculation of temperature 111e may not be based on the phase angle 111g. The temperature before the maximum phase angle is related to stable heating to 100°C. The temperature flat is related to a sudden decrease in the phase angle, which may be associated with 100°C and two states of water. Since liquid water is highly conductive, while steam is not, this phase transition may be another indicator of the state of water. When the temperature continues to increase above 100°C (152) and then continues to increase beyond the second phase angle inflection point 160, it is noteworthy that most of the water has turned into steam.
[0054] Another point of interest that can be understood from the RF output is the sudden spike 170 in power 111b and current 111f during the boiling of the water portion of the RF application, as shown, for example, in Figure 13. This spike can be attributed to the splitting of the tissue during the sealing or melting process. This increase in power and current can be attributed to the fact that the tissue is no longer present beneath the insulating portion of the jaws, e.g., the landing pad. At this point, the jaws are more closed, and the energy phase is only through the sealing surface.
[0055] Since the temperature required to denature collagen starts at 60°C, the application of energy is optimized to maximize time before reaching 100°C. This results in complete and thorough denaturation of collagen. Therefore, all sealing must be completed prior to the spike in power and current of 170, so that the sealing is completed prior to the splitting.
[0056] According to various embodiments, the electrosurgical instrument also has the ability to cut tissue using RF energy, and in one embodiment, by utilizing only the lower jaw when the jaws are in the fully open position, without the coordination of the upper jaw or when the tissue is in contact with the lower jaw but not trapped between the upper and lower jaws. Figure 14 shows the direction of current flow (arrow 140) from the cutting electrode 55 to the rigid lower jaw member 52.
[0057] To achieve tissue cleavage, a high potential difference is created between the cutting electrode 55 and the lower jaw member 52. This results in tissue evaporation due to the heat generated by localized arcing around the cutting electrode. When exposed to high temperatures, the insulating material used to insulate the cutting electrode in one embodiment withstands or performs well at high temperatures. Also, at high potential differences, the insulator has high dielectric strength in one embodiment. The potential difference exceeds 400V-peak to achieve sufficient arcing. However, the actual potential difference is directly related to the distance between the cutting electrode and the lower jaw member.
[0058] Arc extinction is a separate issue, and therefore, power output is limited to rapidly correct RF waveform distortion caused by arcing and / or to prevent degradation of the materials used in the jaw configuration. If the electric arc persists for more than 100 microseconds, the risk of equipment degradation increases. Also, due to the very high heat associated with localized arcing, RF energy applications according to various embodiments include waveforms with a predetermined duty cycle or high crest factor. It has been found that if a crest factor associated with a sinusoidal waveform allows for a constant output, equipment degradation will inevitably occur. By manipulating the duty cycle or crest factor, the average output power is reduced throughout the entire operation of the equipment.
[0059] Electrosurgical instruments in various embodiments also use RF energy, and in one embodiment, utilize only the lower jaw, and only when the jaws are in the fully open position, to melt tissue without the cooperation of the upper jaw or while the tissue is in contact with the lower jaw but not trapped between the upper and lower jaws. Figure 14 illustrates the direction of current flow from the cutting electrode 55 to the rigid lower jaw member 52.
[0060] According to various embodiments, a low potential difference is maintained between the cutting electrode 55 and the lower jaw member 52 to induce tissue coagulation. The potential difference is set to less than 100V-peak to prevent localized arcing, although the actual potential is directly related to the distance between the cutting electrode and the lower jaw member. Tissue coagulation is caused by the heat generated by the RF current between the two electrodes.
[0061] In one embodiment, an insulated wire 44 is routed to electrically couple the first jaw to a wiring harness within the actuator. The insulated wire extends from the distal end of a protective sleeve housed at the proximal end of the second jaw and into the first jaw. The first jaw preferably has a slot positioned to receive the insulated wire. Next, the insulated wire passes through a hole provided in the first jaw and falls into a slot provided in the non-conductive portion. Next, the insulated wire extends to the distal end of the non-conductive portion and through it down to a conductive pad.
[0062] In some embodiments, the geometric shape of the conductive pads of the jaws or the electrodes on the conductive pads is such that the sealing area completely encloses the distal portion of the blade cutting path. According to various embodiments, the dimensions of the jaw surfaces are appropriately proportional to the optimal pressure applied to the tissue between the jaws due to the potential force that the force adjustment mechanism can generate. The surface area is also electrically significant with respect to the surface area in contact with the tissue. This ratio of surface area and tissue thickness is optimized with respect to its relationship to the relative electrical properties of the tissue.
[0063] In one embodiment, as shown in Figure 15, an electrosurgical process, such as a tissue melting process, is initiated by pressing a switch on the instrument or tool (151), thereby starting the initial measurement sequence. With the switch on the tool turned on, the generator takes initial measurements of the tissue (open circuit, short circuit, etc.) (152), and based on these initial measurements, starts or stops supplying RF energy (153). According to various embodiments, the generator measures the tool and / or tissue impedance and / or timing and / or determines whether the phase angle is within an acceptable range. In one embodiment, the generator performs tissue measurements between electrodes of an electrosurgical instrument connected to a generator that utilizes RF energy in a low energy range (e.g., a voltage of about 1 to 10 volts) that does not produce psychological effects (i.e., passive measurement). In various embodiments, the generator uses the initial impedance measurements to determine whether the instrument is short-circuited, faulty, open-circuited, etc. Based on the positive results of the initial check, the generator enables the supply of RF energy from the generator to the electrosurgical instrument and ultimately to the tissue (154). After the RF power has been turned on and the RF power is being supplied continuously by the generator, the generator monitors the phase angle or phase difference and / or change between the power and voltage of the supplied RF energy (155).
[0064] At a predetermined or specified time, under predetermined or specified conditions, or at a predetermined or specified threshold (156), the supply of RF energy is stopped (157). In this case, an acoustic and / or visual signal is issued indicating that tissue is melting (or that an error (e.g., a short circuit in the electrodes) has occurred and / or an unexpected condition (e.g., an acceptable condition despite an unexpected switch release) has occurred). According to various embodiments, a predetermined time, condition, threshold and / or initialization check is determined based on a provided instrument algorithm or script for the connected electrosurgical instrument, procedure or preference. According to various embodiments, the measured tissue tolerance and conductivity or initial phase shift results are used to determine the endpoint for the connected instrument.
[0065] Referring to Figure 16, in one embodiment, the electrosurgical generator 10 is connected to the AC main input, and a power supply 141 converts the AC voltage from the AC main input to a DC voltage to power the various circuits of the generator. The power supply also supplies the DC voltage to an RF amplifier 142, which generates RF energy. In one embodiment, the RF amplifier 142 converts 100VDC from the power supply into a sine wave at a frequency of 350kHz, and this frequency is transmitted through the connected electrosurgical instrument. An RF sense circuit 143 measures / calculates the voltage, current, power and phase at the output of the generator, and the RF energy in the generator is supplied to the connected electrosurgical instrument 20. The measured / calculated information is transmitted to a control device 144.
[0066] In one embodiment, the RF sense analyzes the measured AC voltage and current from the RF amplifier and generates a DC signal for control signals sent to the control device for further processing, such control signals include voltage, current, power, and phase. In one embodiment, the RF sense circuit 143 measures the output voltage and current and calculates the mean square (RMS) of the voltage and current, the apparent power of the RF output energy, and the phase angle of the voltage and current of the RF energy supplied through the connected electrosurgical instrument. In particular, the voltage and current of the output RF energy are processed by the analog circuit of the RF sense to generate real and imaginary components of both voltage and current. These signals are processed by a field-rewritable gate array (FPGA) to give different measurements of voltage and current, such measurements include the AC signal, the phase difference between voltage and current, and the RMS measurement of 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 control device.
[0067] For each instrument port, there is a pair of signals for voltage and a pair of signals for current coming from the RF amplifier 142. In one embodiment, the generator has two redundant RF sense circuits 143a, 143b that measure voltage and current for each instrument at different locations on the RF amplifier. The first RF sense circuit senses the current sent out through the connected electrosurgical instrument on either instrument port 1 or instrument port 2 using a sense resistor, and also senses the voltage measured before and after the return to the output on either instrument port 1 or instrument port 2. The second RF sense circuit senses the current returned from the connected electrosurgical instrument on either instrument port 1 or instrument port 2 using a sense resistor, and also senses the voltages 146a, 146b measured before and after the return to the output on either instrument port 1 or instrument port 2. The voltage input signal is a high-voltage sinusoidal waveform at 350 kHz that is attenuated and AC-coupled by a voltage divider and an inverting filter to remove DC bias on such signal. An inverting filter is used because the voltage and current inputs are 180° out of phase when measured with opposite polarities. For each voltage input signal, two separate inverted and non-inverted voltage sense signals are generated. In one embodiment, differential voltage measurements are performed between the voltage input signals to generate two separate pairs of inverted and non-inverted current sense signals. The current input signal represents the voltage across a shunt resistor on the RF amplifier, and within the RF amplifier, this voltage is proportional to the current flowing through the shunt resistor. The current input signal is a low-voltage sinusoidal waveform at 350 kHz, amplified using a non-inverting filter to remove DC bias from the signal. The RF sense generates signals similar to the result obtained by multiplying each voltage and current signal by a predetermined reference signal. Therefore, the RF sense outputs non-inverted voltage and current sense signals when the waveform is positive, inverted voltage and current sense signals when the waveform is negative, and a ground signal when the waveform is zero.
[0068] The RF sense, according to various embodiments, receives four reference synchronization signals supplied by a control device via an RF amplifier. The synchronization signals are 350 kHz pulse signals having the same duty cycle but different phase shifts, and in one embodiment, they are 90° out of phase with each other. Two of the synchronization signals are used to produce in-phase waveforms to generate the real component of the input waveform, while the other two synchronization signals are used to produce quadrature waveforms to generate the imaginary component of the input. These signals are further processed to generate control signals to a plurality of switches. The outputs of the switches are coupled together to produce a signal output. In one embodiment, a control signal to the switch determines which input signal passes through to become the signal output. According to various embodiments, a first combination allows non-inverting voltage and current sense signals to pass through, which represents multiplying these sense signals by a positive pulse or similar. A second combination allows inverting voltage and current sense signals to pass through, which represents multiplying these sense signals by a negative pulse or similar. A third combination allows a ground signal to pass through, which represents multiplying the sense signal by zero or similarly generating a zero voltage output. Each output is sent to a low-pass filter, which generates a DC voltage corresponding to the real or imaginary component of the detected signal. These signals are supplied to an ADC, which sends the digital signal to an FPGA.
[0069] In one embodiment, the control device 144 controls the RF amplifier 142 to affect the output RF energy. For example, the control device uses information provided by the RF sense 143 to determine whether RF energy should be output and to determine when to stop outputting the RF energy. In one embodiment, the control device determines when to stop outputting the RF energy by comparing a predetermined phase threshold based on the connected electrosurgical instrument 20 and the specific tissue in contact with it. In various embodiments, the control device performs a melting process, which is described in detail below, and in some embodiments, the control device receives commands and setpoints or script data for performing the melting process from data sent from the electrosurgical instrument.
[0070] According to various embodiments shown in Figure 17, the generator has six main subsystems or circuit modules, including a system power source or power supply 145, a control device 144, a front panel interface 146, a novel bipolar instrument interface 147, an RF amplifier 142, and an RF sense 143. According to various embodiments, one or more of the circuits may be combined with or integrated with the other circuits. The power supply 145 is configured to control the power output by providing a DC voltage along with control signals to all other circuits or subsystems. The power supply receives an AC power input of 90-264VAC, 47-63Hz, and in one embodiment, the power supply has an integrated or separate switch configured to connect or disconnect the AC power input to the generator. The control device supports instrument connections for the user interface 121 and electrosurgical instruments 1,2 connected to the electrosurgical generator via the front panel interface (FPI) and the novel bipolar instrument interface (ABDI).
[0071] The RF amplifier 142 generates high-power RF energy, which is passed through the connected electrosurgical instrument and, in one embodiment, an electrosurgical instrument for tissue melting. According to various embodiments, the RF amplifier converts a 100VDC power supply into a high-power sinusoidal waveform having a frequency of 350kHz, which is then sent into the ABDI 147 and ultimately into the connected electrosurgical instrument. The RF sense 143 interprets the measured AC voltage and current from the RF amplifier 142 and generates DC control signals, which are interpreted by the control device 144, and such DC control signals include voltage, current, power, and phase.
[0072] The generator has several dedicated connection receptacles, in the illustrated embodiment, instrument port 1 and instrument port 2, used solely for connection to new bipolar instruments, such as the electrosurgical melting instruments described in detail below. Each dedicated receptacle includes an array spring-pushed probe or a pogo pin. In various embodiments, the generator has a circuit to detect the presence of the new bipolar instrument prior to the energization of the active output terminals at the receptacle.
[0073] The front panel interface (FPI) 146 is configured to drive the display, instrument signals from the control unit, and LED backlights for the front panel buttons. The FPI is also configured to provide power isolation via a regulator and to provide functionality for the front panel switches / buttons. In one embodiment, the ABDI 147 is used as a pass-through connection that connects to the instrument via the FPI. The FPI also allows connection of the connected electrosurgical instrument to the control unit 144 via the ABDI. In one embodiment, this instrument interface is electrically isolated from the rest of the FPI. In various embodiments, the interface has lines for reading and writing to the FRAM® on the new bipolar instrument, reading trigger switches and / or reading signals indicating that the instrument is connected. In one embodiment, an instrument memory circuit is provided that utilizes the control unit's serial peripheral interface (SPI) to read and write to the FRAM of the new bipolar instrument. In one embodiment, a microcontroller is used instead of FRAM, and the interface has interrupt lines, so that all information is transmitted between the electrosurgical instrument and the generator via a digital interface. FPI provides isolation for SPI signals to and from novel bipolar devices via ABDI. In one embodiment, the isolation interface for SPI signals is shared by two novel bipolar devices, and a port pin is used as a chip select.
[0074] According to various embodiments, the generator has an SPI communication bus that allows the control unit to have a bidirectional communication relationship with a composite programmable logic device (CPLD) and an RF sense FPGA. In various embodiments, the FPI provides an SPI interface between the control unit and the connected device via an ABDI connector to communicate with a FRAM on a novel bipolar device. The FPI also provides electrical isolation for low-voltage signals from between the control unit and the ABDI. The device interface on the ABDI is configured to transmit RF energy to the connected device along with isolated interface communication for SPI signals. In one embodiment, the ABDI provides a connection for signals from the device indicating that the device is connected.
[0075] The FPI-ABDI interface provides power to the devices connected to the generator, enables SPI communication between the control unit and the devices, provides device switch signals from the devices to the control unit, and provides device connection signals from the devices to the control unit. ABDI provides RF energy to each connected new bipolar device via a separate pogo pin array. The FPI provides signals from the FPI and RF amplifier, low-voltage power and high-voltage RF power to connected devices via the ABDI connector through the pogo pin array.
[0076] According to various embodiments, the operating engine allows the generator to be configured to accommodate various operation plans, which include, but are not limited to, a wide variety of electrosurgical tools, surgical procedures, and preferences. The operating engine receives and interprets data from an external source and thereby specifically configures the operation of the generator based on the received data.
[0077] The operating engine receives configuration data from a device database script file read from a memory device on the device plug. The script defines the state logic used by the generator. Based on the states defined by the generator and the measurements performed by the generator, the script can define or set the output level and the shut-off criteria. The script includes, for example, in one embodiment, trigger events or indicators that include an indication of a short circuit condition when the measurement phase is greater than 70° or an indication of an open circuit condition when the measurement phase is less than -50°.
[0078] In one embodiment, the operating engine provides system states and user states. System states are default states that control or manage specific default or predetermined operating conditions of the generator, such as states that successfully apply RF energy or indicate an error. In one embodiment, system states are a set of default configurations in which the system is well-functioning (e.g., working as opposed to idle (not working)) and whose functions are hardcoded (coded to remain unchanged) within the electrosurgical generator. For example, the RF Done state is a system state that indicates that the RF energy cycle has been completed without error. User states provide a framework as a means by which customized or specialized operations and values can be established by instructions from an external source relating to a particular instrument, procedure, and / or preference.
[0079] In one embodiment, the script describes system states and their exit conditions, such as expiration times or commands to another state, and where the user state begins. For each user state, operating parameters for the specific state, such as power, voltage, and current setpoints, can be defined or carried over from the previous state. In one embodiment, the user state may provide a specific state for the instrument, operator, or procedure, and in one embodiment, the user state may be provided for a specific state for testing or diagnostic purposes.
[0080] Referring to Figure 18, when the electrosurgical instrument or device 20 is connected, the generator 10 receives script information from the electrosurgical instrument or device 20. The generator uses this script information to determine the number of states and the execution order of the states.
[0081] Script source files or script information 180 written by the device script creator and not present on the device or generator 10 are text or user-readable. Script information is compiled using a script compiler 185 to produce an instrument script database or binary file (SDB) 101. The script binary file is transferred to a memory module by an instrument key programmer 187, which is connectable to or embeddable in an electrosurgical instrument 20 by an instrument key 182. When an electrosurgical instrument is connected to an electrosurgical generator, the generator authenticates the script binary file and / or the instrument (188). The generator verifies the script binary file (189), and if verified, the operating engine utilizes the script to be started by the operation of the connected instrument (190). In one embodiment, the script source file is a text file containing instrument scripts specific to a particular electrosurgical instrument, generator, and / or surgical procedure. In one embodiment, the script source file for an instrument contains information with parameters and scripts (states, functions, events) relating to the electrosurgical generator and / or electrosurgical instrument. After verifying the above, the script compiler assembles the data into a binary format, which constitutes the state machine used by the electrosurgical generator. In one embodiment, the script compiler, as shown in Figure 18, is separate from the electrosurgical generator and is responsible for reading the script source file as text and verifying its contents.
[0082] When a memory module is inserted into the generator, the generator downloads a binary file stored in the ferromagnetic read-write memory (FRAM) or microcontroller located within the module. The binary contains the logic for executing the treatment algorithm. The generator includes firmware / software responsible for processing the binary, authenticating the connected instrument, and executing the binary to implement the treatment algorithm. Thus, the generator is configured to operate only with certified, compliant hand tools.
[0083] In one embodiment, an instrument script or script database represents an instrument process relating to a specific or given instrument. The instrument script is stored in memory connected to or integrated with the instrument, control unit, or a combination thereof. An event handler responds to specific events, such as switch activation / deactivation, instrument position, or exceeding a measurement threshold. An action engine, based on the detected event when applicable in a given event, produces an output to the connected instrument. In one embodiment, the event is a distinct change when a switch is asserted or deasserted.
[0084] A script state is a block or a set of script functions or operating conditions and a script event or indicator. A script function is a configurable instruction for controlling a generator and / or instrument. A script operator is a logical and comparative action performed during script event evaluation. Script parameters are configuration data used by all states and events of the script, and in one embodiment, they are declared within their own dedicated section of the script file. A script event is a distinct change in electrosurgical generator measurement. When a script event occurs, for example, a sequence of script functions is executed.
[0085] According to various embodiments, the phase angle between voltage and current and / or the rate of change of the phase angle are used to maximize the length of time the tissue is within a predetermined temperature range. In one embodiment, the predetermined temperature range is 60°C to 100°C. In one embodiment, a low voltage is used to minimize the temperature effect while accelerating the sealing or melting time.
[0086] According to various embodiments, tissue is gripped between the jaws of a bipolar electrosurgical instrument. The bipolar electrosurgical instrument, detachably connected to an electrosurgical generator, supplies RF energy to be delivered to the tissue upon command. The supplied RF energy has a predetermined voltage range that heats the tissue at a predetermined rate. In one embodiment, the predetermined voltage range is 20 Vrms to 50 Vrms. While the RF energy is being applied, the phase angle between the output voltage and the current is monitored to identify an increase or decrease in phase. Initially, the phase angle is monitored to determine the rate of change of the phase angle from increase to decrease. Once this inflection point occurs, it is assumed that the water in the jaws of the instrument has reached 100°C and is exceeding the temperature required to produce the desired effect on the tissue. Next, a shut-off point is determined to stop the supply of RF energy.
[0087] Exemplary RF energy control processes for electrosurgical generators and associated electrosurgical tools for melting tissue according to various embodiments are shown in Figures 19 to 21. In various embodiments, as shown in Figure 19, the generator supplies energy through the connected electrosurgical tool (251). The generator monitors at least the phase and / or rate of phase change of the supplied RF energy (252). If the phase / phase change is greater than zero or tilted positively (253), the voltage is increased (254). The generator continues to monitor at least the phase and / or rate of phase change of the supplied RF energy (255). If the phase and / or phase change continues to increase (256), the generator continues to monitor the phase and / or phase change. If the phase and / or phase change decreases (257), the process is complete or the termination procedure is initiated and / or the RF energy supplied by the generator is stopped (258).
[0088] In one embodiment, prior to the start of the process, impedance is measured to determine short-circuit or open-circuit conditions via a low-voltage measurement signal sent to the connected electrosurgical tool. In another embodiment, passive impedance is measured to determine whether the grasped tissue is within the operating range (2-200Ω) of the electrosurgical tool. If the initial impedance check is passed, RF energy is supplied to the electrosurgical tool. Thereafter, impedance / resistance is not measured or is ignored.
[0089] Initially, the initial parameters are set to prepare for sealing the tissue placed between the jaws. In one embodiment, voltage and current settings are set to match a specific setting. In one embodiment, the RF energy voltage is applied in a ramping manner starting from 30% of the global setting or a user-selected level (e.g., 27.5-88V for level 1, 25.0-80V for level 2, and 22.5-72V for level 3). The voltage DAC is set to 30% of the voltage setting, which is 25.5Vrms for level 2 (medium). The phase is monitored to determine a phase angle greater than zero degrees, and the tissue and water between the jaws of the electrosurgical instrument are heated at a predetermined slow rate.
[0090] Referring next to Figures 20 and 21, in various embodiments, a generator supplies energy through a connected electrosurgical tool (251). The generator monitors at least the phase and / or rate of phase change of the supplied RF energy (252). If the phase / phase change is greater than zero or tilted positively (253), the voltage is increased (254). In various embodiments, the voltage is increased by a predetermined rate, for example, 50% over 5 seconds, and this voltage is 42.5 Vrms at level 2 (moderate) after the phase has increased to above zero degrees. Ramping continues until predetermined conditions are met. In one embodiment, ramping continues when the monitored phase angle has increased to above approximately 5°. This ensures that the phase is increasing as expected based on the heating of the tissue.
[0091] In the following state (265), if the monitored phase angle increases beyond a predetermined phase value, e.g., 5°, the phase is continued to be monitored for the increasing state or condition. This is assumed to indicate that such an increasing condition is an indicator that the temperature of the tissue and water between the jaws is increasing but is below 100°C. However, a monitored phase indicating a decreasing state or condition yields a different indicator. This is assumed to indicate that the temperature of the tissue and water between the jaws has reached at least 100°C and / or that the desired effect on the tissue is complete, e.g., that the tissue has been sealed and / or cut.
[0092] In one or more of the following conditions, check whether there are conditions that increase or decrease the monitored phase angle. According to various embodiments, various small-scale or periodic checks are performed in conjunction with various small-scale or periodic updates to various predetermined thresholds or indicators, thereby determining the conditions for increasing or decreasing phase angles or rates of change.
[0093] The indicator is that the effect on the desired tissue is complete, for example, that the tissue is sealed and / or cut, if it is determined that the phase angle, the rate of change of the phase angle, or the trend is decreasing rather than increasing, based on one or more of the following conditions. Therefore, it is assumed that in such an indicator, the temperature of the tissue and water between the jaws has reached at least 100°C.
[0094] In such a state or the following state, the voltage ramping or increase of the output RF energy is reduced or decreased. Thus, the rapid boiling of water is reduced or prevented, the temperature is kept steady or constant, and eventually reaches a predetermined condition. In one embodiment, the predetermined condition is that the phase angle is reduced to at least 5°.
[0095] According to various embodiments, in the following state (266), if the monitored phase angle is increasing beyond a predetermined phase value, e.g., 10°, the system continues to monitor whether there is an increasing phase state or condition. However, if the monitored phase angle indicates a decreasing state instead, e.g., decreasing below a predetermined phase value, e.g., 5° (268), or if a predetermined time limit is reached, the voltage increase is stopped (280). Next, if the monitored phase angle continues to indicate a decreasing state, e.g., decreasing below a predetermined phase value, e.g., 5° (268), or if a predetermined time limit is reached, the RF energy is stopped and the process ends (281).
[0096] If the monitored phase angle indicates, for example, an increasing state in the following state (267), and the monitored phase angle is increasing beyond a predetermined phase value, for example 12.5°, the phase continues to be monitored to see if the increasing state or condition continues. If the monitored phase angle is different and now indicates a decreasing state, for example, decreasing below a predetermined phase value, for example 7.5° (269), or a predetermined time limit is reached, the voltage increase is stopped (280). Next, if the monitored phase angle continues to indicate a decreasing state, for example, decreasing below a predetermined phase value, for example 5° (268), or a predetermined time limit is reached, the RF energy is stopped and the process ends (281).
[0097] In the following state (270), if the monitored phase angle indicates an increasing state, for example, if it is increasing beyond a predetermined phase value, e.g., 15°, the voltage increase is stopped (271), and the phase continues to be monitored for an increasing state or condition. However, if the monitored phase angle is otherwise and indicates an increasing state, for example, if it is decreasing below a predetermined phase value, e.g., 10° (277), or if a predetermined time limit is reached, the voltage increase is stopped (280). Next, if the monitored phase angle continues to indicate a decreasing state, for example, if it is decreasing below a predetermined phase value, e.g., 5° (282), or if a predetermined time limit is reached, the RF energy is stopped and the process ends (281). In the following state (272), if the monitored phase angle indicates an increasing state, for example, if it is increasing beyond a predetermined phase value, e.g., 20°, the phase continues to be monitored for an increasing state or condition. If the monitored phase angle differs from this and indicates a decreasing state, for example, if it decreases below a predetermined phase value, e.g., 10° (277), or if a predetermined time limit is reached, the phase continues to be monitored for the decreasing state or condition. Next, if the monitored phase angle decreases below a predetermined phase value, e.g., 5° (282), or if a predetermined time limit is reached, the RF energy is stopped and the process ends (281).
[0098] In the following state (273), if the monitored phase angle continues to indicate an increasing state, for example, if it is increasing beyond a predetermined phase value, for example, 25°, the phase is continued to be monitored with respect to the increasing state or condition. If the monitored phase angle is otherwise decreasing below a predetermined phase value, for example, 15° (278), or if a predetermined time limit is reached, the phase is continued to be monitored with respect to the decreasing state or condition. Next, if the monitored phase angle is increasing below a predetermined phase value, for example, 5° (282), or if a predetermined time limit is reached, the RF energy is stopped and the process ends (281). In the following state (274), if the monitored phase angle is increasing beyond a predetermined phase value, for example, 30°, the phase is continued to be monitored with respect to the increasing state or condition. If the monitored phase angle is otherwise decreasing below a predetermined phase value, for example, 15° (278), or if a predetermined time limit is reached, the phase is continued to be monitored with respect to the decreasing state or condition. Next, if the monitored phase angle decreases to a predetermined phase value, for example 5° (285), or if a predetermined time limit is reached, the RF energy is stopped and the process ends (281).
[0099] In the following state (275), if the monitored phase angle is increasing beyond a predetermined phase value, e.g., 35°, the phase continues to be monitored for increasing states or conditions. However, if the monitored phase angle is decreasing to a predetermined phase value, e.g., 15° (278), or if a predetermined time limit is reached, the phase continues to be monitored for decreasing states or conditions. Next, if the monitored phase angle decreases to a predetermined value, e.g., 5° (282), or if a predetermined time limit is reached, the RF energy is stopped and the process ends (281). In the following state (276), if the monitored phase angle is increasing beyond a predetermined phase value, e.g., 40°, the phase is monitored for decreasing states or conditions, and if the monitored phase angle decreases to a predetermined phase value, e.g., 15° (278), or if a predetermined time limit is reached, the phase continues to be monitored for decreasing states or conditions. Next, if the monitored phase angle decreases to a predetermined phase value, e.g., 5° (282), or if a predetermined time limit is reached, the RF energy is stopped and the process is terminated (281). As is assumed and noted, with respect to the exemplary and operationally sealing / melting and cutting / incision processes or systems provided above and described throughout this application, the frequency of the fine checks and / or increasing or decreasing states, e.g., indications of a predetermined angle or rate of change to increase or decrease, may vary to result in different and varied levels and finer levels of adjustment or control that are desired or required based on the specific electrosurgical equipment, generator, tissue and / or surgical procedure.
[0100] Figures 22-24 are graphical diagrams illustrating vascular sealing / melting utilization systems and processes according to various embodiments of the present invention. As shown, the success rate 223 of providing tissue sealing beyond approximately 3 × systolic burst pressure was high, and the time 223 for sealing vessels up to a size of 4 mm was short, for example, less than 2 seconds. The time for sealing vessels over 4-7 mm was also shortened, for example, less than 5 seconds. The time for the phase angle to decrease from its maximum value to a predetermined phase value, for example 5°, was longer than the time for sealing up to 4 mm. Such changes or decreases in sealing time while providing good vascular sealing results according to various embodiments, for example, withstanding systolic burst pressures exceeding 3 times, are improved by identification and / or triggering at the inflection point of the derivative of the phase trend and incorporated into a fine check, state index or threshold. In various embodiments, the inflection point of the derivative of the phase trend is identified as the point where the phase trend changes from an increasing state to a decreasing state.
[0101] As shown in Figure 23, the blood vessel has a diameter of 6.62 mm, is successfully sealed, and exhibits a burst pressure of, for example, 12.7 psi. In addition, as shown in the figure, the phase angle 230g increases when RF energy is applied. The rate of increase and the tissue temperature 230d are not rapid, but rather sufficiently slow. The inflection point 231, for example, the point where the phase changes from increasing to decreasing, occurs about 1.5 seconds before the RF energy is stopped. As shown in Figure 24, the blood vessel has a diameter of 1.89 mm, is successfully sealed, and exhibits a burst pressure of, for example, 13 psi. The overall trends of the phase angle 240g and temperature 240d are almost the same as in the previous blood vessel sealing, but the time scale shown in Figure 24 is about 1 / 4 the time scale of Figure 23. Furthermore, as shown in the figures, phases 230g and 240g are indicated relative to other organizational readings or indicators, such as voltage 230a and 240a, power 230b and 240b, impedance 230e and 240e, energy 230c and 240c, temperature 230d and 240d, and current 230f and 240f. In addition, as shown in Figures 23 and 24, in various embodiments, the generator is configured not to measure or calculate one or more of the indicators or readings, such as temperature or energy, in order to reduce operating costs and power costs, as well as power consumption and / or the number of components in the generator. Additional information or readings are generally provided or indicated for the relevant purposes.
[0102] As noted, the impedance of the tissue is near its minimum value over the entire sealing cycle. This, in turn, provides low voltage and high current, thus resulting in a consistent power delivery throughout the entire sealing cycle. Effective or consistent power delivery reduces heat spread. According to various embodiments, the time for sealing can be reduced, resulting in a reduction of voltage output to less than 50 Vrms and / or power output to less than 50 watts. To avoid misreading, according to various embodiments, the electrosurgical generator does not measure the resistance or impedance of the tissue while supplying RF energy to the tissue.
[0103] According to various embodiments, electrosurgical systems are provided that reduce the spread of heat to seal blood vessels or tissues in contact with bipolar electrosurgical instruments by controlling and effectively supplying RF energy, thereby enabling low power levels and efficient power delivery.
[0104] As described throughout this application, the electrosurgical generator ultimately 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 surgical procedures. The electrosurgical instrument includes a memory containing commands and parameters that, in conjunction with the electrosurgical generator, determine the operation of the instrument. For example, in a simple case, the generator can supply RF energy, but the connected instrument determines how much energy to apply. However, the generator ensures that the supply of RF energy cannot exceed a set threshold, even if determined by the connected instrument, thereby providing a check or guarantee against fault instrument commands.
[0105] Next, focusing on some operational aspects of the electrosurgical tools or instruments described herein according to various embodiments, once a bundle of blood vessels or tissue is identified for melting, cutting, or both, the first jaws and the second jaws are positioned around the tissue. The movable handle 23 is squeezed to move it proximal to the stationary housing 28. As the movable handle moves proximal, the first jaws rotate toward the second jaws, effectively clamping the tissue. High-frequency energy is applied to the tissue by pressing the activation button provided on the stationary handle. Once the tissue has been melted, cut, or both, the movable handle is opened again.
[0106] Alternatively or additionally, when the jaws are in the fully open position or an intermediate position between the fully open position and the engaged position, high-frequency energy may be applied to the tissue in contact with the lower surface or portion of the lower jaw by pressing an activation button or a separate activation button to melt and / or cut the tissue.
[0107] As outlined above and described in detail below, various electrosurgical instruments, tools, or devices can be used in the electrosurgical systems described herein. For example, electrosurgical grippers, scissors, forceps, probes, needles, and other instruments including one, some, or all of the features described herein can provide various advantages in an electrosurgical system. Various embodiments of electrosurgical instruments and generators, and combinations thereof, have been described throughout this application. Generally, it is assumed that one, some, or all of the features described throughout this application can be included in any of the embodiments of instruments, generators, and combinations thereof described below. For example, it may be desirable that each of the described instruments has a memory for interaction with the generators described above, and vice versa. However, in other embodiments, the described instruments and / or generators may be configured to interact with a standard bipolar high-frequency power supply without interaction with instrument memory. Furthermore, although various embodiments have been described in terms of modules and / or blocks for the sake of clarity, such modules and / or blocks can be embodied by one or more hardware components, such as processors, digital signal processors (DSPs), programmable logic circuits (PLDs), application-specific integrated circuits (ASICs), open circuits, registers and / or software components, such as programs, subroutines, logic and / or combinations of hardware and software components. Similarly, such software components are interchangeable with hardware components or combinations thereof, and vice versa.
[0108] Electrosurgical units, instruments and connections thereto, and other embodiments of their operation and / or function are described in U.S. Patent Application No. 12 / 416,668 (Title of Invention: Electrosurgical System), filed April 1, 2009, U.S. Patent Application No. 12 / 416,751 (Title of Invention: Electrosurgical System), filed April 1, 2009, U.S. Patent Application No. 12 / 416,695 (Title of Invention: Electrosurgical System), filed April 1, 2009, U.S. Patent Application No. 12 / 416,765 (Title of Invention: Electrosurgical System), filed April 1, 2009, and U.S. Patent Application No. 12 / 416,128 (Title of Invention: Electrosurgical System), filed March 31, 2009. These patent documents are incorporated herein by reference, and their entire contents are incorporated as part of this specification. 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 (Title: Electrosurgical Fusion Device), filed May 16, 2014, U.S. Provisional Patent Application No. 61 / 944,185 (Title: Electrosurgical Generator with Synchronous Detector), filed May 16, 2014, U.S. Provisional Patent Application No. 61 / 994,415 (Title: Electrosurgical System), filed May 16, 2014, U.S. Provisional Patent Application No. 61 / 944,192 (Title: Electrosurgical Generator), filed May 16, 2014, and the entirety of these disclosures is incorporated herein by reference.
[0109] The above description is provided to enable those skilled in the art to manufacture and use surgical instruments and to carry out the methods described herein, and such description describes the optimal embodiment envisioned by the inventors carrying out the invention. However, various modifications remain obvious to those skilled in the art. These modifications are intended to fall within the scope of the invention. In addition, various embodiments or aspects of such embodiments are shown in various figures and described throughout the specification. However, it should be noted that each embodiment and its aspects, although illustrated or described separately, can be combined with one or more other embodiments and their aspects unless otherwise specified. Each combination is not explicitly described only for the sake of readability of this specification. Furthermore, the embodiments of the invention should be considered in all respects as illustrative and not limiting to the invention.
Claims
1. Electrosurgical instruments, Having the first Joe, It has a first jaw and a second jaw facing it, and the first jaw and the second jaw are rotatably arranged to grip tissue between the first jaw and the second jaw, Having an electrode connected to the first jaw, An electrosurgical instrument having electrodes connected to the second jaw, wherein the electrodes of the first and second jaws are arranged to melt and cut the tissue between the first and second jaws using high-frequency energy, with no electrodes in the central portions of the first and second jaws facing each other.
2. The electrosurgical instrument according to claim 1, wherein the first jaw has a landing pad provided on the central portion of the first jaw.
3. The electrosurgical instrument according to claim 1 or 2, wherein the landing pad is compressible, and the landing pad is compressed when the jaws grip and melt tissue between the jaws.
4. The electrosurgical instrument according to any one of claims 1 to 3, wherein the landing pad is made of silicone.
5. The electrosurgical instrument according to any one of claims 1 to 4, wherein portions of the landing pads provided at various points on the first jaw adjacent to the electrode of the first jaw are in contact with the electrode of the second jaw.
6. The electrosurgical instrument according to any one of claims 1 to 5, wherein the landing pad extends along the entire length of the first jaw.
7. The first electrode has a first surface area that contacts the tissue, and the second electrode has a second surface area that contacts the tissue, and the first surface area is equal to the second surface area. The second jaw has a third electrode having a third surface area in contact with tissue and a fourth electrode having a fourth surface area in contact with tissue, wherein the third surface area is equal to the fourth surface area, and the fourth surface area is greater than the first surface area. The electrosurgical instrument according to any one of claims 1 to 6, wherein the first electrode and the third electrode are arranged to melt tissue located between the first jaw and the second jaw using high-frequency energy on one side of the longitudinal axis, and the second electrode and the fourth electrode are arranged to melt tissue located between the first jaw and the second jaw using high-frequency energy on the opposite side of the longitudinal axis.
8. The electrosurgical instrument according to any one of claims 1 to 7, wherein the second jaw has a fifth electrode provided on a surface facing away from the first jaw.
9. The electrosurgical instrument according to any one of claims 1 to 8, wherein the fifth electrode has a surface area smaller than the first surface area.
10. The electrosurgical instrument according to any one of claims 1 to 9, wherein the landing pad is positioned directly above the fifth electrode and the third and fourth electrodes at various points.
11. The electrosurgical instrument according to any one of claims 1 to 10, wherein the second jaw further comprises a slot fully housed within the second jaw, the slot having a proximal closed end and a distal closed end.
12. The electrosurgical instrument according to any one of claims 1 to 11, wherein the landing pad is positioned directly above the slot.
13. The electrosurgical instrument according to any one of claims 1 to 12, wherein the slot has a surface area equal to the surface area of the fifth electrode.
14. The electrosurgical instrument according to any one of claims 1 to 13, wherein the slot defines a surface area narrower than the surface area of the landing pad.
15. The electrosurgical instrument according to any one of claims 1 to 14, wherein the third electrode and the fourth electrode are arranged to cut tissue located between the first jaw and the second jaw using high-frequency energy transmitted between the electrodes.
16. The electrosurgical instrument according to any one of claims 1 to 15, wherein the fifth electrode is arranged to cut tissue located outside the second jaw using high-frequency energy transmitted between the fifth electrode and the fourth electrode, but only when the tissue is not gripped between the jaws.
17. The electrosurgical instrument according to any one of claims 1 to 16, wherein the first electrode and the fourth electrode are arranged to have the same polarity as the first electrode and the third electrode are arranged to have equal polarity as the first electrode and different polarity from the first and fourth electrodes in order to melt tissue located between the first jaw and the second jaw.
18. An electrosurgical instrument according to any one of claims 1 to 17, used in combination with an electrosurgical generator configured to supply radio frequency (RF) energy through the electrosurgical instrument to melt and cut tissue.
19. The generator is, An RF amplifier that supplies RF energy via the electrosurgical instrument configured to melt and cut tissue, An electrosurgical instrument according to any one of claims 1 to 18, comprising a control device configured to periodically monitor the phase angle of the supplied RF energy, wherein the control device sends a signal to the RF amplifier to increase the voltage of the supplied RF energy when the monitored phase angle is greater than zero and increasing.
20. The electrosurgical instrument according to any one of claims 1 to 19, wherein the control device sends a signal to the RF amplifier to stop supplying the RF energy when the monitored phase angle is decreasing.
21. The electrosurgical instrument according to any one of claims 1 to 20, wherein the control device periodically monitors the rate of change of the phase angle of the supplied RF energy.
22. The electrosurgical instrument according to any one of claims 1 to 21, wherein the control device sends a signal to the RF amplifier to stop the supplied RF energy when the rate of change of the phase angle falls below a predetermined threshold.
23. The electrosurgical device according to any one of claims 1 to 22, wherein the control device continues to send a signal to the RF amplifier to increase the voltage of the RF energy if the monitored phase angle continues to exceed a predetermined threshold angle.
24. The electrosurgical instrument according to any one of claims 1 to 23, wherein the RF amplifier increases the voltage at a predetermined constant rate.
25. The electrosurgical instrument according to any one of claims 1 to 24, wherein the predetermined threshold angle is 5°.
26. The electrosurgical instrument according to any one of claims 1 to 25, wherein the predetermined threshold angle is 5° to 15°.
27. The electrosurgical instrument according to any one of claims 1 to 26, wherein the control device sends a signal to the RF amplifier to stop the voltage increase of the supplied RF energy if the monitored phase angle exceeds a predetermined threshold angle while the RF amplifier continues to supply RF energy.
28. The electrosurgical instrument according to any one of claims 1 to 27, wherein the predetermined threshold angle is less than 15°.
29. The electrosurgical instrument according to any one of claims 1 to 28, wherein the RF amplifier maintains the temperature between the jaws below 100°C while increasing the voltage of the RF energy.
30. The electrosurgical instrument according to any one of claims 1 to 29, wherein the RF amplifier stops supplying the RF energy when the temperature between the jaws exceeds 100°C.
31. The electrosurgical instrument according to any one of claims 1 to 30, wherein the generator measures the voltage and current of the supplied RF energy and monitors the phase angle from the measured voltage and current.
32. The electrosurgical instrument according to any one of claims 1 to 31, wherein the generator continues to supply the RF energy when the monitored phase angle is less than 40°.
33. The electrosurgical instrument according to any one of claims 1 to 32, wherein the control device sends a signal to the RF amplifier to stop the supplied RF energy when the phase angle falls below a predetermined threshold.
34. The electrosurgical instrument according to any one of claims 1 to 33, wherein the predetermined threshold angle is 5°.
35. Electrosurgical instruments, It includes a first jaw having a first electrode having a first surface area in contact with tissue and a second electrode having a second surface area in contact with tissue, wherein the first surface area is equal to the second surface area. The apparatus includes a second jaw coupled to the first jaw so as to grip tissue between itself and the first jaw, the second jaw having a third electrode having a third surface area in contact with the tissue and a fourth electrode having a fourth surface area in contact with the tissue, wherein the third surface area is equal to the fourth surface area and the fourth surface area is greater than the first surface area. An electrosurgical instrument wherein the first electrode and the third electrode are arranged to melt tissue located between the first jaw and the second jaw using high-frequency energy on one side of the longitudinal axis, and the second electrode and the fourth electrode are arranged to melt tissue located between the first jaw and the second jaw using high-frequency energy on the opposite side of the longitudinal axis.
36. The electrosurgical instrument according to claim 35, wherein the second jaw has a fifth electrode provided on a surface facing away from the first jaw.
37. The electrosurgical instrument according to claim 35 or 36, wherein the fifth electrode has a surface area smaller than the first surface area.
38. The electrosurgical instrument according to any one of claims 35 to 37, wherein the first jaw further comprises landing pads positioned directly above the fifth electrode and at various points above the third and fourth electrodes.
39. The electrosurgical instrument according to any one of claims 35 to 38, wherein the second jaw further comprises a slot fully housed within the second jaw, the slot having a proximal closed end and a distal closed end.
40. The electrosurgical instrument according to any one of claims 35 to 39, wherein the landing pad is positioned directly above the slot.
41. The electrosurgical instrument according to any one of claims 35 to 40, wherein the slot has a surface area equal to the surface area of the fifth electrode.
42. The electrosurgical instrument according to any one of claims 35 to 41, wherein the slot defines a surface area narrower than the surface area of the landing pad.
43. The electrosurgical instrument according to any one of claims 35 to 42, wherein the third electrode and the fourth electrode are arranged to cut tissue located between the first jaw and the second jaw using high-frequency energy transmitted between the electrodes.
44. The electrosurgical instrument according to any one of claims 35 to 43, wherein the fifth electrode is arranged to cut tissue located outside the second jaw using high-frequency energy transmitted between the fifth electrode and the fourth electrode, but only when the tissue is not gripped between the jaws.
45. The electrosurgical instrument according to any one of claims 35 to 44, wherein the first electrode and the fourth electrode are arranged to have the same polarity as the first electrode and the third electrode are arranged to melt tissue located between the first jaw and the second jaw, and are identical to each other and have a polarity different from that of the first and fourth electrodes.
46. An electrosurgical instrument according to any one of claims 35 to 45, used in combination with an electrosurgical generator configured to supply radio frequency (RF) energy through the electrosurgical instrument to melt and cut tissue.
47. The generator is, An RF amplifier that supplies RF energy via the electrosurgical instrument configured to melt and cut tissue, An electrosurgical instrument according to any one of claims 35 to 46, comprising a control device configured to monitor the phase angle of the supplied RF energy, wherein the control device sends a signal to the RF amplifier to increase the voltage of the supplied RF energy when the monitored phase angle is greater than zero and increasing.
48. The electrosurgical instrument according to any one of claims 35 to 47, wherein the control device sends a signal to the RF amplifier to stop supplying the RF energy when the monitored phase angle is decreasing.
49. The electrosurgical instrument according to any one of claims 35 to 48, wherein the control device periodically monitors the rate of change of the phase angle of the supplied RF energy.
50. The electrosurgical instrument according to any one of claims 35 to 49, wherein the control device sends a signal to the RF amplifier to stop the supplied RF energy when the rate of change of the phase angle falls below a predetermined threshold.
51. The electrosurgical device according to any one of claims 35 to 50, wherein the control device continues to send a signal to the RF amplifier to increase the voltage of the RF energy if the monitored phase angle continues to exceed a predetermined threshold angle.
52. The electrosurgical device according to any one of claims 35 to 51, wherein the RF amplifier increases the voltage at a predetermined constant rate.
53. The electrosurgical instrument according to any one of claims 35 to 52, wherein the predetermined threshold angle is 5°.
54. The electrosurgical instrument according to any one of claims 35 to 53, wherein the predetermined threshold angle is 5° to 15°.
55. The electrosurgical instrument according to any one of claims 35 to 54, wherein the control device sends a signal to the RF amplifier to stop the voltage increase of the supplied RF energy if the monitored phase angle exceeds a predetermined threshold angle while the RF amplifier continues to supply RF energy.
56. The electrosurgical instrument according to any one of claims 35 to 55, wherein the predetermined threshold angle is less than 15°.
57. The electrosurgical instrument according to any one of claims 35 to 56, wherein the RF amplifier maintains the temperature between the jaws below 100°C while increasing the voltage of the RF energy.
58. The electrosurgical instrument according to any one of claims 35 to 57, wherein the RF amplifier stops supplying the RF energy when the temperature between the jaws exceeds 100°C.
59. The electrosurgical device according to any one of claims 35 to 58, wherein the generator measures the voltage and current of the supplied RF energy and monitors the phase angle from the measured voltage and current.
60. The electrosurgical device according to any one of claims 35 to 59, wherein the generator continues to supply the RF energy when the monitored phase angle is less than 40°.
61. The electrosurgical instrument according to any one of claims 35 to 60, wherein the control device sends a signal to the RF amplifier to stop the supplied RF energy when the phase angle falls below a predetermined threshold.
62. The electrosurgical instrument according to any one of claims 35 to 61, wherein the predetermined threshold angle is 5°.
63. An electrosurgical generator configured to supply radio frequency (RF) energy to melt and cut tissue, wherein the generator is An electrosurgical generator comprising an RF amplifier that supplies RF energy via a detachably coupled electrosurgical melting and cutting device configured to melt and cut tissue using only RF energy, and a control device configured to monitor the phase angle of the supplied RF energy, wherein the control device sends a signal to the RF amplifier to increase the voltage of the supplied RF energy when the monitored phase angle is greater than zero and increasing.
64. The electrosurgical generator according to claim 63, wherein the control device sends a signal to an RF amplifier to stop supplying the RF energy when the monitored phase angle is decreasing.
65. The electrosurgical generator according to claim 63 or 64, wherein the control device periodically monitors the rate of change of the phase angle of the supplied RF energy.
66. The electrosurgical generator according to any one of claims 63 to 65, wherein the control device sends a signal to the RF amplifier to stop the supplied RF energy when the rate of change of the phase angle falls below a predetermined threshold.
67. The electrosurgical generator according to any one of claims 63 to 66, wherein the control device continues to send a signal to the RF amplifier to increase the voltage of the RF energy if the monitored phase angle continues to exceed a predetermined threshold angle.
68. The RF amplifier increases the voltage at a predetermined constant rate, as described in any one of claims 63 to 67.
69. The electrosurgical generator according to any one of claims 63 to 68, wherein the predetermined threshold angle is 5°.
70. The electrosurgical generator according to any one of claims 63 to 69, wherein the predetermined threshold angle is 5° to 15°.
71. The electrosurgical generator according to any one of claims 63 to 70, wherein the control device sends a signal to the RF amplifier to stop the voltage increase of the supplied RF energy if the monitored phase angle exceeds a predetermined threshold angle while the RF amplifier continues to supply RF energy.
72. The electrosurgical generator according to any one of claims 63 to 71, wherein the predetermined threshold angle is less than 15°.
73. The electrosurgical generator according to any one of claims 63 to 72, wherein the RF amplifier maintains the temperature between the jaws below 100°C while increasing the voltage of the RF energy.
74. The electrosurgical generator according to any one of claims 63 to 73, wherein the RF amplifier stops supplying the RF energy when the temperature between the jaws exceeds 100°C.
75. The electrosurgical generator according to any one of claims 63 to 74, wherein the generator measures the voltage and current of the supplied RF energy and monitors the phase angle from the measured voltage and current.
76. The electrosurgical generator according to any one of claims 63 to 75, wherein the generator continues to supply the RF energy when the monitored phase angle is less than 40°.
77. The electrosurgical generator according to any one of claims 63 to 76, wherein the control device sends a signal to the RF amplifier to stop the supplied RF energy when the phase angle falls below a predetermined threshold.
78. The electrosurgical generator according to any one of claims 63 to 77, wherein the predetermined threshold angle is 5°.
79. The electrosurgical generator according to any one of claims 63 to 78, wherein the electrosurgical melting and cutting device comprises an elongated shaft, a pair of jaws provided at the distal end of the elongated shaft, and an actuator provided at the proximal end of the elongated shaft, configured to open and close the jaws to cut tissue located between the jaws.
80. The electrosurgical generator according to any one of claims 63 to 79, wherein the electrosurgical melting and cutting device has a pair of electrodes provided on a first jaw and a pair of electrodes provided on a second jaw and configured to transmit RF energy between the first jaw and the second jaw to melt and cut the tissue located between the first jaw and the second jaw.
81. The electrosurgical generator according to any one of claims 63 to 80, wherein the electrosurgical melting and cutting device has a pair of electrodes provided on a first jaw and a pair of electrodes provided on a second jaw, and the pair of electrodes provided on the second jaw is configured to transmit RF energy only between the first jaw and the electrode pair provided on the second jaw to perform both melting and cutting of tissue located between the first jaw and the second jaw.
82. The electrosurgical melting and cutting device has a pair of electrodes provided on a first jaw and a pair of electrodes provided on a second jaw, wherein the pair of electrodes provided on the second jaw is configured to transmit RF energy only between the first jaw and the electrode pair provided on the second jaw to first melt the tissue located between the first jaw and the second jaw, and then cut it, according to any one of claims 63 to 81.