Adjustable electrosurgical blade with tip electrode

Abstract

An electrosurgical device includes: a sheath; an electrode extending from the sheath, the electrode including a cross-sectional profile having a multi-apex cross-sectional shape; an insulating disk positioned on the electrode at a distal end of the sheath; and an actuator connected to the insulating disk to move the insulating disk along the electrode. A method for performing surgery on tissue includes: inserting an insert sheath into an anatomical structure to position an electrode close to target tissue; adjusting an insulating disk connected to the electrode to adjust the distance between the distal end face of the electrode and the insulating disk; and supplying energy to the electrode to cut the target tissue.

Description

Cross-reference to related applications

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 553,751, filed February 15, 2024, and U.S. Provisional Patent Application No. 63 / 599,643, filed November 16, 2023, the contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure generally relates to medical devices comprising an elongated body configured to be inserted into an incision or opening in a patient’s anatomy to provide tissue-cutting capability.

[0003] More specifically, this disclosure relates to medical devices, such as electrosurgical scalpels, having exposed electrodes extending from a catheter to provide cutting capabilities. Background Technology

[0004] Electrosurgical scalpels, or electrocautery knives, are widely used in surgical procedures. An electrosurgical knife can be connected to a generator that produces a high-frequency current. It can be connected to a counter-electrode plate that contacts the living tissue and a treatment electrode located at the tip of the scalpel, which performs incisions and coagulation on the living tissue. The counter-electrode plate is configured with a large contact area with the living tissue to reduce the current density. However, because the treatment electrode is thin, the current density is very high. Therefore, Joule heating is generated between the living tissue and the treatment electrode, causing rapid evaporation of water from the cells, resulting in the cutting of the living tissue and the thermal solidification or ablation of the cut surface. As described above, an electrosurgical knife is characterized by its ability to perform incisions accompanied by hemostasis. Summary of the Invention

[0005] In some cases, electrosurgical scalpels are used in conjunction with endoscopic systems, where the endoscope is inserted into the patient's body to reach anatomical structures located deep within the body. For example, an electrosurgical scalpel can be used to treat reproductive organs accessed by insertion into the esophagus. The electrosurgical scalpel is delivered to the anatomical structure through the lumen within the endoscope. Therefore, the cross-sectional area of ​​the electrosurgical scalpel must typically be small to operate within the lumen of the endoscope. A typical electrosurgical scalpel includes a sheath or catheter through which electrode wires extend. The tips of the electrode wires can extend from the sheath to perform treatment on the tissue.

[0006] This disclosure recognizes that the problems to be solved using conventional electrosurgical scalpels include, among others, A) fluid injection positioned along the side of the electrode, which may require retracting the electrode to inject the fluid; B) the inability to adjust the cutting length of the electrode; and C) the need to use multiple electrosurgical scalpels if insulation of the tip is required. Regarding A), the fluid injection system may involve injecting fluid from the distal end of the sheath of the electrosurgical scalpel. The fluid can be injected into the sheath of the electrosurgical scalpel to flow along the outer side of the electrode. However, in order to accurately spray the fluid, the tip of the electrode is typically retracted into the sheath to allow fluid to escape. This retraction of the electrode tip can be inconvenient during surgery. For example, after irrigation, the tip of the electrode needs to be repositioned relative to the anatomy. Regarding B), the electrode wire is typically constructed to extend from the sheath by a fixed amount, such as fully retracted or fully extended. The extended length of the tip can be sufficient to perform a wide range of surgeries, but not all. For example, some surgeries benefit from performing cuts with different cutting depths. It is difficult for surgeons to manually perform cuts shorter than the length of the electrode extending from the sheath. Therefore, these procedures require the use of multiple electrosurgical instruments with different cutting lengths. Regarding C), typical electrosurgical instruments are either constructed with or without insulated tips. Insulated tips prevent the distal end of the electrode from contacting tissue, thus facilitating cutting along the length of the electrode rather than at the tip. Therefore, to use either configuration, one instrument must be retracted to insert the other.

[0007] This disclosure provides a solution to these and other problems by providing an electrosurgical scalpel comprising: A) a fluid injection passage located within an electrode, for example at the center of the electrode, which allows fluid injection without retracting the electrode; B) a movable insulating disk that can slide along the electrode to change the effective cutting length of the electrode and thereby control the cutting depth; and C) a movable insulating disk that can slide along the electrode to form an insulating tip and prevent the tip of the electrode from contacting tissue. Regardless of the location of the insulating disk, it can be used without increasing the overall outer diameter of the instrument or the cutting diameter of the device. The electrosurgical scalpel of this disclosure can facilitate such features by having a star-shaped or multi-pointed cutting electrode, which can have an enlarged cross-sectional area to accommodate the internal fluid passage. The tip of the star-shaped electrode can provide cutting in multiple directions along an edge similar to the edge of the electrode wire. The star-shaped cross-sectional profile of the electrode and the insulating disk can facilitate the sliding and stability of the insulating disk. Furthermore, the electrodes and other components of this disclosure can include various coatings to prevent or inhibit tissue adhesion to the electrode.

[0008] In the example, the electrosurgical device may include: a sheath; an electrode extending from the sheath, the electrode including a cross-sectional profile having a multi-aperture cross-sectional shape; an insulating disk positioned on the electrode at a distal end of the sheath; and an actuator connected to the insulating disk to move the insulating disk along the electrode.

[0009] In another example, a method for performing surgery on tissue may include: inserting an insert sheath into an anatomical structure to position an electrode close to the target tissue; adjusting an insulating disk connected to the electrode to adjust the distance between the distal end face of the electrode and the insulating disk; and providing energy to the electrode to cut the target tissue. Attached Figure Description

[0010] Figure 1 This is a schematic diagram of an electrosurgical scalpel system suitable for use with this disclosure.

[0011] Figure 2 It is a schematic frontal cross-sectional view of the patient's body, showing an electrosurgical device inserted into an endoscope that extends into the patient's anatomy to reach the target anatomical structure.

[0012] Figure 3 This is a schematic three-dimensional diagram of an electrosurgical treatment device that extends from an endoscope to interact with the target anatomical structure.

[0013] Figure 4 This is a schematic perspective view of the electrosurgical device disclosed herein, which includes a sheath, a star-shaped electrode, an actuator including a push rod, and an insulating disc.

[0014] Figure 5 yes Figure 4 3D exploded view of the electrosurgical device.

[0015] Figure 6 yes Figure 4 End view of the electrosurgical device.

[0016] Figure 7 This is a schematic cross-sectional view of the distal end portion of the electrosurgical device disclosed herein, showing the actuator, control wires, and fluid conduit.

[0017] Figure 8 yes Figures 4 to 7 A plan view of the electrosurgical device, showing the control handle.

[0018] Figure 9 yes Figure 8 A plan view of the control handle, showing the actuation mechanism, locking system, and fluid inlet.

[0019] Figure 10 yes Figure 9A perspective view of a portion of the locking system, showing a stop member connected to an actuator for an insulating disc.

[0020] Figure 11A yes Figure 10 A schematic cross-sectional view showing that the stop is inside the locking knob so that the stop cannot pass through the locking knob.

[0021] Figure 11B yes Figure 10 A schematic cross-sectional view showing a stop within the locking knob, allowing the stop to pass through the locking knob.

[0022] Figure 12A This is a schematic diagram of the electrosurgical device disclosed herein, in which an insulating disk is in a advancing state around a star-shaped electrode.

[0023] Figure 12B This is a schematic diagram of the electrosurgical device disclosed herein, in which an insulating disk surrounds a star-shaped electrode in the middle.

[0024] Figure 12C This is a schematic diagram of the electrosurgical device disclosed herein, in which an insulating disk is retracted around a star-shaped electrode.

[0025] Figure 13 This is a block diagram illustrating the operation of a method for performing surgical procedures using the electrosurgical device of this disclosure.

[0026] Figure 14 This is an end view of an electrode used in the electrosurgical device of this disclosure, wherein the electrode does not include a central flushing channel.

[0027] Figure 15 This is an end view of the four-pointed star-shaped electrodes used in the electrosurgical device of this disclosure.

[0028] Figure 16 This is an end view of an electrode with a four-pointed square for use in the electrosurgical device of this disclosure.

[0029] Figure 17 This is a perspective view of the electrosurgical device used in this disclosure, including electrodes with a multi-lobed body and an insulating disk.

[0030] Figure 18A yes Figure 17 A three-dimensional view of the electrodes, showing the insulating disk located at the distal end.

[0031] Figure 18B yes Figure 17 A three-dimensional view of the electrodes, showing the insulating disk located in the middle position.

[0032] Figure 18C yes Figure 17A three-dimensional view of the electrodes, showing the insulating disk located at the proximal end. Detailed Implementation

[0033] Figure 1 This is a schematic diagram illustrating a configuration suitable for use with the present disclosure in an electrosurgical treatment device. The treatment device 11 may include a handheld component 12, a power supply unit 13, and a cable 14 connecting the handheld component 12 and the power supply unit 13. The handheld component 12 may include a retaining portion 15 forming a housing, a vibration generating section (transducer) housed within the retaining portion 15, a probe 17 connected to the vibration generating section, and a sheath 18 covering the periphery of the probe 17 to protect it. The retaining portion 15 is connected to one end of the cable 14. The other end of the cable 14 is connected to the power supply unit 13. The retaining portion 15 may be, for example, cylindrical.

[0034] The retaining part 15 is provided with an energy operation input button 21. The doctor can operate the energy operation input button 21 and thereby apply energy (e.g., ultrasonic vibration and high-frequency current) to the body tissue to be treated via the probe 17.

[0035] The probe 17 can be formed as a rod, for example, made of a biocompatible metallic material (such as titanium alloy). Ultrasonic vibrations are transmitted from the vibration-generating section to the probe 17, and high-frequency current is supplied to the probe 17 from the high-frequency current supply section 28. Therefore, the probe 17 not only applies ultrasonic vibrations to body tissue but also serves as the first electrode (active electrode) of a monopolar electrosurgical scalpel. The processing device 11 of this disclosure may have a return electrode (not shown) serving as the second electrode of the monopolar electrosurgical scalpel. The return electrode can be connected via a wire to the high-frequency current supply section 28 and is positioned during surgery at a location where the return electrode contacts the patient outside the body. One of the two directions parallel to the longitudinal axis C of the probe 17 is defined as the distal direction C1, and the direction opposite to the distal direction is defined as the proximal direction C2 (see [link to documentation]). Figure 1 ).

[0036] The distal end portion of the probe 17 protrudes from the distal end of the sheath 18. That is, the sheath 18 may include a cylindrical body that covers the middle portion of the probe 17 and the proximal end portion of the probe 17 opposite to the distal end portion.

[0037] The power supply unit 13 includes an ultrasonic current supply section 26, a high-frequency current supply section 28, and an energy control section 43 that controls the ultrasonic current supply section 26 and the high-frequency current supply section 28. The energy control section 43 can control the supply of ultrasonic generating current from the ultrasonic current supply section 26 and the supply of high-frequency current from the high-frequency current supply section 28. The ultrasonic current supply section 26 and the high-frequency current supply section 28 are examples of energy generating sections. When a doctor operates the energy operation input button 21 (switch), an electrical signal is transmitted to the energy control section 43 and the energy operation input is detected. Therefore, the energy control section 43 supplies the ultrasonic generating current from the ultrasonic current supply section 26 to the probe 17 and supplies the high-frequency current from the high-frequency current supply section 28 to the probe 17.

[0038] The doctor can operate the energy input button 21 while the probe 17 is in contact with body tissue. In this state, the probe vibrates with ultrasound and applies heat energy from frictional motion to the body tissue. Simultaneously, a high-frequency current flows from the probe 17 to the body tissue, thereby applying electrical energy to the body tissue. Because both types of energy are applied from the probe 17, the body tissue in contact with the probe 17 can be effectively cut, and the surrounding tissue can be effectively coagulated. In this example, only one type of energy can be used.

[0039] A doctor can coagulate body tissue by operating the energy input button 21 while the probe 17 is in contact with the tissue. Therefore, blood flow from the tissue can be stopped by cauterization. Additionally, the doctor can use the probe 17 to cut / remove body tissue (especially membranous tissue, such as the mesentery) by operating the energy input button 21 while the probe 17 is in contact with the tissue.

[0040] In the example, probe 17 can be configured to include the following references. Figures 4 to 7 The characteristics of the described electrode.

[0041] In the example, Akagane’s patent No. US10,368,896 B2, entitled “Treatment Device,” describes an electrosurgical system suitable for use with this disclosure, the entire contents of which are incorporated herein by reference.

[0042] Figure 2This is a schematic frontal cross-sectional view of a patient's body 200, showing an electrosurgical processing device 202 inserted into an endoscope 204 extending into the patient's anatomy to reach a target anatomical structure 206. The body 200 may include an esophagus 210, stomach 212, uterus 214, and fallopian tubes 216. The electrosurgical processing device 202 may include a sheath 220, a cutting wire 222, a handle 224, and a tubing 226. The tubing 226 may be connected to a power source 228 and a fluid source 229. The endoscope 204 may include a handle 230, a cable 232, a port 234, an insertion tube 236, and a control knob 238.

[0043] Figure 2 The illustration schematically depicts the introduction of an electrosurgical treatment device 202 into a body 200 using an endoscope 204 to cut the patient's fallopian tube 216 with a cutting wire 222. The electrosurgical treatment device 202 may include... Figure 1 The processing device 11. Furthermore, the electrosurgical processing device 202 can be configured to include the components described herein. Figures 4 to 7 Electrode 304 and Figures 8 to 11B The handle 350. In the illustrated example, the insertion tube 236 of the endoscope 204 can be inserted into the patient's mouth (not shown), through the esophagus 210, and into the stomach 212. An incision 218 can be formed in the wall of the stomach 212 to allow the insertion tube 236 to enter the peritoneal cavity from inside the stomach 212 and approach the patient's pelvic organs. For simplicity, only the uterus 214 and fallopian tubes 216 are shown. The electrosurgical processing device 202 can pass through an internal working channel or lumen within the insertion tube 236 connected to the port 234. A sheath 220 can extend from the distal end of the insertion tube 236, and a cutting filament 222 can protrude from the distal end of the sheath 220. The cutting filament 222 can press against one of the fallopian tubes 216 to form an incision therein. Handle 224 may be attached to the proximal end of sheath 220 to allow the operator to retract the cutting wire 222 into and out of the sheath 220. Handle 224 may be connected to tubing 226, which may supply RF current from an RF generator (e.g., power source 228) to the cutting wire 222. Handle 224 may be used to protrude and retract the cutting wire 222 from the distal end of sheath 220. However, the cutting wire 222 may be positioned relative to an anatomical structure by manipulating the insertion tube 236 of endoscope 204, such as by pushing or pulling the insertion tube 236 and / or operating control knob 238. The movement of the distal end of the insertion tube 236 may be controlled using control knob 238, for example by inducing a bend in the bending segment 240.

[0044] Figure 3 The diagram shows Figure 2An enlarged view of the target anatomical structure 206 shows one of the fallopian tubes 216 extending from the uterus 214. The target anatomical structure 206 may include the fallopian tube 216 located within the peritoneal cavity 250 of the abdomen 252, near other pelvic organs 254. In the example, it may be desirable to sever the fallopian tube from the uterus 214 during a tubal ligation procedure, thereby preventing the egg from traveling from the ovary into the fallopian tube, thus rendering the patient infertile. Figure 3 The illustration shows the distal end of the insertion cannula 236 of the endoscope 204, which has a bend 240. The bend 240 is illustrated as being positioned within the peritoneal cavity 250 of the patient's lower abdomen. A cutting filament 222 and a sheath 220 protrude from the distal end of the insertion cannula 236 and are positioned near one of the patient's fallopian tubes 216. As illustrated, when an RF current is applied to the cutting filament 222, the cutting filament 222 can press against the fallopian tube 216. The direction of movement of the cutting filament 222 can be controlled by grasping the portion of the insertion cannula 236 extending from the patient's mouth and pushing or pulling it to advance or retract the cutting filament 222, or by using a control knob 238 on the handle 230 to manipulate the angle of the bend 240.

[0045] In the example, an electrosurgical system and an endoscope system suitable for use with this disclosure are described in Barlow et al.’s patent No. 8,715,281 B2 entitled “Treatment Device for Endoscope,” the entire contents of which are incorporated herein by reference.

[0046] Figure 2 and Figure 3 The illustration shows examples of surgical procedures that can be performed using the electrosurgical device 202, such as tubal ligation. The electrosurgical device of this disclosure can be used for other procedures, such as endoscopic submucosal dissection (ESD). The electrosurgical device of this disclosure can be used in many surgical applications for cutting, coagulating, dissecting, electrocauterizing, ablating tissue, and shrinking tissue. The electrosurgical device of this disclosure can be used in many surgical settings, such as gastroenterology, general surgery, obstetrics and gynecology, otolaryngology, pulmonary medicine, dermatology, etc.

[0047] like Figure 3As illustrated, in many cases, pressing the cutting wire 222 against the fallopian tube 216 in the direction of arrow 256 can force the fallopian tube 216 downward (in the illustrated orientation) against the underlying pelvic organ 254, thereby potentially causing the cutting wire 222 to undesirably cut the body tissue. Therefore, depending on the presence and location of surrounding anatomical structures, approaching the fallopian tube 216 from different directions such as above and / or below may be advantageous. Utilizing this disclosure, the cutting wire 222 can have a cross-sectional profile with multiple tips projecting in different orientations to preserve and realize the ability of the cutting wire to cut in multiple directions using fine tips.

[0048] As previously described, conventional systems inject fluid at the distal end of the sheath, on one side of the cutting suture. The cutting suture may interfere with the ejected fluid. Therefore, to eject fluid, such as water or saline, from the sheath 220, it is typically necessary to retract the cutting suture 222 into the sheath 220. Using this disclosure, the cutting suture 222 can be configured with a forward-spraying nozzle having an internal lumen from which fluid can be ejected, thereby allowing fluid to be dispensed while the cutting suture 222 is held in the desired position. Thus, among other benefits, the fluid can be injected more accurately onto the surgical side.

[0049] Furthermore, the distance by which the cutting wire 222 extends from the sheath 220 is typically set to a fixed distance. That is, the cutting wire 222 is typically pushed forward to its furthest position at the handle 224 for use, making it difficult to use the intermediate position between fully retracted and fully extended. Using this disclosure, the insulating disc can be locked in multiple positions along the cutting wire 222 to prevent the cutting wire 222 from cutting near the end of the insulating disc, and also to control the cutting depth.

[0050] This disclosure includes a dual-function electrosurgical scalpel that can be used in ESD surgery. The scalpel—for example… Figures 4 to 7The cutting wire 222 or electrode 304—can be made of surgical stainless steel with a tip design, such as a six-pointed star design. The blade length can be 3.5 mm. This design reduces material usage while maintaining strength, resulting in more efficient cutting. This design can also have sharp edges in multiple directions, ready to cut with minimal carbonization. Therefore, cutting can be performed by movement of the blade in any direction. The blade can have an insulating disc, such as a ceramic slider, with one or more actuating rods that can push and pull the insulating disc forward and backward to multiple positions, such as three positions. The first position can lock the cutting depth at, for example, 2 mm, and the second position can set the cutting depth at, for example, 1.5 mm. The third position can transform the blade into a tip-insulated blade. The insulating disc can be locked into these positions. Compared to conventional systems, the electrosurgical scalpel of this disclosure can have increased usability and can be manufactured at a reasonable cost relative to the increased functionality. For example, the scalpel of this disclosure can be cheaper than two scalpels required to provide similar functionality or usability.

[0051] Figure 4 This is a schematic diagram of the electrosurgical device 300 disclosed herein, which includes a sheath 302, an electrode 304, an insulating disc 306, and an actuator 308. Figure 5 yes Figure 4 Exploded three-dimensional view of the electrosurgical device 300. Figure 6 yes Figure 4 End view of the electrosurgical device 300. Unless otherwise stated, it is discussed simultaneously. Figure 4 , Figure 5 and Figure 6 .

[0052] According to this disclosure, the features of the sheath 302, electrode 304, and insulating disk 306 can be combined with... Figure 1 Within the sheath 18 and probe 17. According to this disclosure, the features of the sheath 302, electrode 304, and insulating disk 306 can be combined with… Figure 3 In the sheath 220 and the cutting wire 222.

[0053] The sheath 302 may include a tubular body 310 having a lumen 312. The tubular body 310 may include an elongated flexible member configured for, for example, through an endoscope 204 ( Figure 2 The device is inserted into the patient to deliver electrode 304 to the target anatomical structure. In examples, the tubular body 310 may include a polymer tube, a plastic tube, or a rubber tube. The lumen 312 may define a space for components of the electrosurgical device 300 that need to reach the distal end of the sheath 302, such as... Figure 7The actuator 308, fluid line 342, and control wire 340 can be positioned in this space for connecting the electrode 304 to the handle 350 of the electrosurgical device 300. Figure 8 Other near-end components, such as energy source 228 and fluid source 229, are located at the same location. Figure 2 ).

[0054] The insulating disc 306 may include a plate-shaped body 330 having a channel 332. The plate-shaped body 330 may be designed to prevent electrical energy and / or heat energy from flowing from the control wire 340. Figure 7 The plate-shaped body 330 is made of an insulating material. In the example, the plate-shaped body 330 may be made of an alumina material, a ceramic material, or a porcelain material. In the example, the plate-shaped body 330 may be made of a polymer, a low-carbon content polymer, or nylon. In the example, the plate-shaped body 330 may be made of metal for attachment to the actuator 308 as described below, and subsequently coated with an insulating material. The plate-shaped body 330 may have a thickness T, such as... Figure 5 As shown in the diagram. The thickness T can range from about 0.5 mm to about 2.0 mm. The thickness T is sufficient to allow the farthest end face 338 of the insulating disk 306 to extend beyond the farthest end face 334 of the electrode 304 while keeping the nearest end face of the insulating disk 306 engaged with the electrode 304. Therefore, as shown in the diagram. Figure 12A As discussed, the insulating disk 306 can provide a buffer to prevent the tip of the electrode 304 from contacting tissue, thereby forming an insulating tip. The channel 332 may include a cut shaped to have a matching profile that matches the cross-sectional profile of the elongated body 320. The channel 332 may extend through the thickness of the plate-like body 330.

[0055] Actuator 308 may include one or more elongated bodies 309, such as wires or rods, having connections to handle 224. Figure 2 ) or handle 350 ( Figure 9 The proximal end of the elongated body 309 and the distal end connected to the insulating disk 306. The elongated body 309 may be located, for example, in the control feature section such as the handle 350. Figure 8The lever 365 on the actuator 308 is pushed and pulled to move the insulating disc 306 back and forth along the elongated body 320. The elongated body 309 may include a metal body attached to the insulating disc 306 in any suitable manner. In an example, the elongated body 309 of the actuator 308 may be welded to the insulating disc, and the insulating disc may subsequently be coated with an insulating material, for example, by an impregnation or spraying process. In an example, the elongated body 309 may be riveted to the insulating disc 306. In an example, the elongated body 309 may be inserted through an opening or channel within the insulating disc 306 and then deformed to provide a mechanical connection or weld. In an example, the elongated body 309 may be coated with an insulating material to prevent the transmission of electricity through it. In an example, the elongated body 309 may be configured to receive enable energy from the control wire 340 to provide additional cutting edges. Therefore, the size or diameter of the elongated body 309 can be selected to enhance cutting performance.

[0056] Electrode 304 may include an elongated body 320 and a lumen 322. As discussed in detail below, the electrode may be electrically connected to handle 224. Figure 2 ), to receive, for example, energy from pipeline 226 via energy source 228 ( Figure 2 The lumen 322 is electrically connected to the handle 224, and the lumen 322 can be fluidly connected to the handle 224. Figure 2 ) to receive fluid from fluid source 229 ( Figure 2 The fluid is [missing information]. In use, electrode 304 can be configured to move axially relative to sheath 302. See reference [missing information]. Figure 8 For a more detailed discussion, handle 224 ( Figure 2 The device may include a slider 354 for advancing and retracting the electrode 304, and stops 356 and 358 for limiting the movement of the insulating disk 306. However, the electrode 304 may be positioned in a fixed position within the sheath 302. To control the cutting depth or cutting length of the electrode 304, an actuator 308 may be used to move the insulating disk 306 along the electrode 304.

[0057] like Figure 5 As shown, the elongated body 320 may have a cross-sectional profile with multiple points 324 and grooves 326. In the example, the electrode 304 may be made of stainless steel and may be pressed, extruded, machined, etc. In the example, the electrode 304 may be cold-hammered. In the example, the electrode 304 may be made of tungsten or another thermally conductive material to allow the electrode 304 to be heated using enable energy to enhance the cutting process. In the example, the electrode 304 may be rigid so as not to be bent.

[0058] Each of these tips 324 can form a cutting edge that allows the electrode 304 to cut in multiple directions. Each tip 324 of the electrode 304 can extend along an edge parallel to axis AA, providing cutting capability in the radial direction. In the illustrated example, the elongated body 320 has a star-shaped cross-sectional profile. Specifically, in the illustrated example, the cross-sectional profile of the elongated body 320 can include a six-pointed star that provides cutting in six directions spaced sixty degrees apart. However, other cross-sectional profile shapes with one or more apexes or vertexes to form cutting edges or narrower cutting surfaces can be used. Thus, apexes can include tips, such as along the edge of a star-shaped electrode or a straight electrode, or apexes can include curved surfaces, such as those on a leaf-shaped or clover-shaped electrode. In the example, the electrode 304 can have a cross-sectional profile that is a five-pointed star or a four-pointed star. Figure 15 Alternatively, a triangular cross-sectional profile or a square cross-sectional profile can be used. Figure 16 The flat surface of the triangle can be spaced apart from the interior of the cavity 312 to provide space for the actuator 308 and other components. Alternatively, a leaf-shaped cross-sectional profile can be used, wherein the arcuate tips of the leaf-shaped portions can serve as cutting surfaces, and the gaps between the leaf-shaped portions can serve as space for other components, such as the actuator 308, fluid conduits, and other components.

[0059] The slot 326 may form a channel or recess within the elongated body 320 for receiving the elongated body 309 or for receiving wires that can actuate the insulating disc 306. The slot 326 may include a recess located radially inward of the radial outer diameter of the elongated body 320. The slot 326 provides space for other features or components of the electrosurgical device 300, such as the actuator 308. Therefore, including the actuator 308 within the electrosurgical device 300 does not increase the overall size of the device, such as its outer diameter. In particular, the actuator 308 may be fitted within the outer periphery of the electrode 304, for example, radially inward of the tip 324. Figure 14As shown in the diagram. Therefore, actuator 308 does not require or will not occupy space on the radially outer side of electrode 304 within sheath 302, for example, radially outer side of tip 324. Actuator 308 may include an elongated body 309 disposed within slot 326. Elongated body 309 may include a pair of elongated bodies located circumferentially opposite, for example, 180 degrees apart, around the periphery of elongated body 320. Slot 326 may extend axially parallel to axis AA. In the illustrated example, the bottom of slot 326 is pointed, making the slot V-shaped. However, the bottom of slot 326 may have other shapes, such as rounded or semi-circular, to form a U-shaped slot, which, compared to a V-shape, increases the space within the slot. Slot 326 may facilitate cooling of electrode 304, for example, by reducing the mass of electrode 304 and increasing the surface area of ​​electrode 304. Slot 326 and thickness T may also facilitate axial alignment of insulating disk 306 with electrode 304. For example, the multiple tips 324 and grooves 326 that engage with the channels 332 on the insulating disk 306 can prevent the insulating disk 306 from binding along the electrode 304 when it is pushed or pulled along the electrode 304. The distance or gap between the channels 332 and the elongated body 320 can be small to facilitate the scraping of debris from the electrode 304 by the insulating disk 306 and to facilitate axial alignment between the electrode 304 and the insulating disk 306.

[0060] like Figure 6 As shown, the star-shaped cross-sectional profile of the elongated body 320 can form a central portion 336 on the radially inner side of the groove 326, the central portion 336 providing space for accommodating the lumen 322. The lumen 322 may include a passage or opening through which fluid can pass to reach the distal end face 334. The elongated body 320 can be connected to a fluid source 229 ( Figure 2 This provides flushing capability. As illustrated, lumen 322 may include a circular passage, but may have other cross-sectional shapes, including square, rectangular, oval, elliptical, etc. Lumen 322 may be manufactured by any suitable process, such as casting or machining. In the example, lumen 322 may be omitted, such as... Figure 14 As shown. The size, such as the diameter, of the central portion 336 can be changed by altering the depth of the groove 326 within the elongated body 320. Therefore, the depth of the groove 326, the number of tips 324, the width of the tips 324, and the diameter of the lumen 322 can be selected by the capabilities of the balancing electrode 304, such as the number of cutting edges, the thickness of the cutting edges, the volume of the groove 326 used to hold other components, and the volume of fluid to be transported by the lumen 322. Furthermore, as... Figure 6As shown, the height H of the insulating disk 306 beyond the tip 324 can be small, so that the outer diameter of the electrosurgical device 300 does not increase significantly beyond the diameter of the electrode 304. Furthermore, regardless of the axial position of the electrode 304—for example, whether it is within the sheath 302, adjacent to the sheath 302, or located at the distal end of the sheath 302—the insulating disk 306 can remain within the outer diameter OD of the sheath 302. Therefore, using the insulating disk 306 to form a tip-insulated electrode does not affect the overall dimensions of the cuts that can be performed by the electrode 304.

[0061] Figure 7 This is a schematic cross-sectional view of the distal end portion of the electrosurgical device 300 disclosed herein, showing the control wire 340, fluid conduit 342, and elongated body 309 of actuator 308. Electrode 304 may be disposed within the lumen 312 of tubular body 310. Insulating disc 306 may be disposed around electrode 304 at the distal end of tubular body 310. Elongated body 309 of actuator 308 may extend from the proximal side of insulating disc 306 through lumen 312 to reach handle 350. Figure 8 ).

[0062] In the example, electrode 304 can extend continuously back to handle 224, such that, for example... Figure 4 The cross-sectional shape illustrated extends all the way to handle 224. In the illustrated example, electrode 304 may partially extend into sheath 302, and another conductor, such as one or more wires or cables, such as control wire 340 ( Figures 7 to 9 Electrode 304 can be connected to handle 224 or handle 350. Control wire 340 may have a smaller diameter than electrode 304 to facilitate the flexing of sheath 302.

[0063] The elongated body 309 of the actuator 308 can be connected to the proximal end face of the insulating disk 306, and can extend proximally together with the electrode 304 to a control feature, such as the lever 365. Figure 9 The actuator 308 may include one or more rods or wires that can be pulled and pushed to translate the insulating disc 306 along the electrode 304 in order to adjust the cutting length of the electrode 304 and scrape tissue or debris from the electrode 304.

[0064] Control wire 340 may include a conductor, such as wire or cable, which can transmit enabling energy—such as electrical, thermal, and / or RF energy—from energy source 228. Figure 2 The signal is transmitted to electrode 304. In this example, control wire 340 may be made of a conductive metal, such as copper, aluminum, or steel, and may be flexible.

[0065] Fluid conduit 342 can be connected to electrode 304 at lumen 322. Fluid conduit 342 can be connected to fluid source 229. Figure 2 This allows fluid to be delivered to the proximal end of electrode 304. Fluid conduit 342 may be made of flexible tubing or tube, such as plastic or polymer tubing.

[0066] Figure 8 yes Figures 4 to 7 A plan view of an electrosurgical device 300, showing a handle 350. The electrosurgical device 300 may include a sheath 302 and electrodes 304. The handle 350 may include a handle body 352, a slider 354, a stop 356, a stop 358, an electrical connector 360, and a fluid port 362. In this example, the handle 350 may include... Figure 2 The handle 224.

[0067] The handle 350 can be connected to the sheath 302, and the electrode 304 can extend from the distal end of the sheath 302. The handle 350 may include a fluid port 362, which can be fluidly connected to a fluid tube 342. Figure 7 ) and fluid source 229 ( Figure 2 The handle 350 may include a button or actuator (e.g.,) that can control the flow of enable energy from the energy source 228, such as via the electrical connector 360 and control wire 340, to the electrode 304. Figure 1 Input button 21). Additionally, energy source 228 may include a button or actuator for controlling the flow of enable energy to control wire 340 and electrode 304. Handle 350 may include lever 365 connected to actuator 308 to adjust the position of insulating disc 306, thereby positioning insulating disc 306 at, for example... Figure 12A , Figure 12B and Figure 12C At different locations. The handle 350 may include adjustment devices, such as stops 356 and 358, that can prevent movement of the lever or wire of the actuator 308.

[0068] As discussed, electrode 304 can be configured to protrude from the distal end of tubular body 310. Sheath 302 can be long enough to completely penetrate endoscope 204. Figure 2 The sheath 302 has an internal cavity and may have additional length for ease of use. The proximal end of the sheath 302 can be connected to the handle body 352. A slider 354 on the handle body 352 can be connected to the proximal end of the control cable 340. The control cable 340 can extend through the internal cavity of the sheath 302 (e.g., ...). Figure 4The internal cavity 312 of the sheath 302 can be used to control the wire 340 to move back and forth. The operator can move the slider 354 of the handle 350 forward and backward to move the control wire 340 back and forth. The slider 354 can be advanced forward (e.g., distally) to move the electrode 304 to an advanced position where the electrode 304 protrudes from the internal cavity of the sheath 302, and the slider 354 can be retracted backward (e.g., proximally) to retract the electrode 304 back into the sheath 302. In the example, the electrode 304 may be positioned within the sheath 302, for example, where the electrode 304 protrudes from the cavity 312 (…). Figure 4 In the fixed position, the insulating disk 306 controls the effective cutting length of the electrode 304.

[0069] Furthermore, the proximal end of the control cable 340 can be connected to an electrical connector 360 mounted on the slider 354. (Electric wire, for example...) Figure 2 The conduit 226 can be connected to the electrical connector 360 to bring RF electrosurgical current from a standard electrosurgical generator (e.g., power source 228) to the device. The RF current can then travel through the electrical connector 360 and the control wire 340 to the electrode 304 connected to the front end of the control wire 340.

[0070] Fluid port 362 can be connected to fluid source 229 ( Figure 2 ), to supply fluid to the handle 350. The fluid port 362 can be connected to the fluid tube 342 connected to the lumen 322 of the electrode 304 ( Figure 7 The fluid port 362 can be coupled to the handle body 352 at the slider 364 to allow the fluid port 362 to move as the electrode 304 moves.

[0071] Figure 9 yes Figure 8 Enlarged view of handle 350. Control cable 340 in... Figure 9 The lines shown are dashed or dotted. Actuator 308 is... Figure 9 The line shown in the middle is a solid line. Figure 9 The diagram illustrates a control wire 340 extending from a slider 354 within the handle body 352. The control wire 340 can extend from the handle body 352 through stops 358 and 356 to reach the tubular body 310. However, for illustrative purposes, the control wire 340 is shown as being covered by an actuator 308 within a portion of the handle body 352. The actuator 308 can extend within the handle body 352 from the stops 358 into the stops 366, through the stops 356, along one side of the notch 368, and then into the tubular body 310. For simplicity, the actuator 308 is not shown within the tubular body 310.

[0072] Mark 368 may include graduations or other information to provide an indication of the position of the insulating disk 306 relative to the farthest end face 334 of the electrode 304, thereby providing an indication of how much the electrode 304 can be cut. For example, mark 368 may provide text such as "1.5 mm", "2.0 mm", etc., to indicate the length of the electrode 304 between the farthest end face 334 of the electrode 304 and the farthest end face 338 of the insulating disk 306. Lever 365 may be used to advance actuator 308 to move the insulating disk 306 to the position indicated by mark 368. Lever 365 may be directly connected to actuator 308 or may be connected to stop 366. Figure 9 As shown, lever 365, stop 366, and actuator 308 can be seen and accessed through a window or cutout through handle body 352. As described below, actuator 308 can be locked in place using one or more stops, such as stop 356 and stop 358, to secure insulating disc 306, for example, to fix the position of insulating disc 306.

[0073] Figure 10 This is a perspective view of a stop 366 connected to an actuator 308 used in this disclosure for an insulating disk 306. Figure 11A yes Figure 10 A schematic cross-sectional view of a stop 366 within a stop 356, which prevents the stop 366 from passing through the stop 356. Figure 11B yes Figure 10 The stop 366 is within the stop 356 such that the stop 366 can pass through the stop 356 in a schematic cross-sectional view.

[0074] Stop 366 can be connected to actuator 308 to control the axial movement of control wire 340 and insulating disc 306. Stop 358 is illustrated as being located at the proximal end of stop 366, and stop 356 is located at the distal end of stop 366. However, stop 366 can be configured to move through each of stops 356 and 358 depending on the direction of rotation of stops 356 and 358. Stops 356 and 358 may include knobs that can be rotated to lock and unlock actuator 308. In the example, stops 356 and 358 can be located in a fixed position along handle body 352. However, in Figure 8 and Figure 9 In the example, stops 356 and 358 can be threaded into the handle body 352, and the positions of stops 356 and 358 can be adjusted by the user by rotating the movable stop 356 axially forward or axially backward on the mating thread of the handle body 352.

[0075] like Figure 11A and Figure 11BAs shown, the stop 356 may include a cutout 370 that can accommodate a protrusion 372 of the stop 366. The body 375 of the stop 366 may be axially collinear with the actuator 308 to move through the interior of the stop 356. However, the protrusion 372 may be long enough to extend beyond the interior of the stop 356 to engage the stop 356. When the stop 356 is rotated to the left to the "restricted" position, as... Figure 11A As shown, the cut 370 is offset from the protrusion 372, thereby preventing the protrusion 372 from passing through it. However, when the stop 356 is rotated to the right to the "free" position, as... Figure 11B As shown, the cut 370 is aligned with the protrusion 372, thereby allowing the protrusion 372 to pass through the stop 356.

[0076] Stop 358 can be configured similarly to stop 356, such that stop 356 and stop 358 can constitute consecutive or sequential stops for actuator 308. Stop 358 can allow electrode 304 to extend beyond sheath 302 by a first amount, and stop 356 can allow electrode 304 to extend beyond sheath 302 by a second amount, which is greater than the first amount. In the example, stop 356 can position insulating disk 306 approximately 1.5 mm from the farthest end face 334, and stop 358 can position insulating disk 306 approximately 2.0 mm from the farthest end face 334. Indicator features, such as arrows, can be located on actuator 308 to point to text or numbers on mark 368, thereby providing an indication of the current cut length of electrode 304.

[0077] Figure 12A An insulating disk 306 is shown in an extended state along electrode 304. In its most distal state, the insulating disk 306 may be located near the distal end face 334 of electrode 304. In the example, the distal end face 338 of the insulating disk 306 may be located distal to the distal end face 334 of electrode 304 to ensure that electrode 304 is spaced apart from tissue joined by the insulating disk 306. In the example, the thickness of the insulating disk 306 may be from approximately 0.5 mm to approximately 2.0 mm, plus or minus ten percent. In the example, the insulating disk 306 may be thicker than 2.0 mm. Figure 12A In terms of position, electrode 304 can be configured as a tip-insulated electrode.

[0078] Figure 12B An insulating disk 306 is shown in an intermediate state along electrode 304. In this intermediate state, the insulating disk 306 can be located between the farthest end face 334 of electrode 304 and sheath 302. The insulating disk 306 can be located at any position between the farthest end face 334 and sheath 302. In the example, the intermediate position can be 2.0 mm or 1.5 mm away from the farthest end face 334, plus or minus 10 percent.

[0079] Figure 12C The insulating disk 306 is shown in its retracted state along electrode 304. In the closest end state ( Figure 12C The insulating disc 306 may be adjacent to the sheath 302. In the example, the insulating disc 306 may be retracted into the sheath 302. In the example, the electrode 304 may protrude from the sheath 302 by approximately 3.5 mm, plus or minus 10 percent. coating

[0080] In the example, one, some of, or all of the electrode 304, insulating disk 306, and actuator 308 may be provided with one or more layers to prevent tissue from adhering to these components. In the example, the layers may include coatings or etched layers.

[0081] Non-stick coatings can be applied to parts of electrosurgical devices to provide anti-tissue adhesion (anti-adhesion) properties. Any material capable of providing the desired function (i.e., reducing tissue adhesion while maintaining sufficient electrical conduction to allow for tissue sealing) can be used as a non-stick coating, provided that the material is sufficiently biocompatible. In some examples, the material can be porous to allow for electrical conduction.

[0082] In the example, the non-stick layer may include a hydrophobic coating, a superhydrophobic / extra-hydrophobic coating, a hydrophilic coating, or a superhydrophobic / extra-hydrophilic coating.

[0083] As used herein, "liquid-repellent" or "superliquid-repellent" structures generally describe any material exhibiting anti-liquid properties, such as materials possessing one or more of the following: hydrophobic (repelling water), lipophobic (repelling oils and lipids), amphiphobic (materials that are both hydrophobic and lipophobic), hemophobic (repelling blood or blood components). Such materials repel liquids, for example, by causing liquids to bead up on the surface of the material without spreading or wetting the surface. Therefore, as used herein, substrates described as including liquid-repellent structures include substrates comprising liquid-repellent substrates, superliquid-repellent substrates, hydrophobic substrates, superhydrophobic substrates, amphiphobic substrates, and / or superamphiphobic substrates.

[0084] When a drop of liquid (e.g., a water-based liquid, a lipid-based liquid, etc.) is placed on a surface, the liquid will spread to a certain extent on that surface, depending on factors such as the surface tension of the liquid and the substrate, and the smoothness or roughness of the surface. For example, the hydrophobicity of a substrate can be increased by various coatings that reduce the surface energy of the substrate. The quantification of hydrophobicity can be expressed in degrees as the contact angle (or contact angle) of the droplet on the surface.

[0085] For example, on a surface with high surface energy (i.e., above the surface tension of a droplet), a drop of liquid will spread and "wet" the surface of the substrate. Such a surface exhibits hydrophilicity rather than hydrophobicity. As the surface energy of the substrate decreases, hydrophobicity increases (and as the surface energy of the substrate increases, hydrophobicity decreases).

[0086] Hydrophobicity, lipophobicity, and / or amphiphobicity refer to the property of a substrate that allows a droplet to have a contact angle of 90 degrees (°) or greater on the substrate surface. "Superhydrophobicity," "superamphiphobicity," "extreme hydrophobicity," and "superliquidity" all refer to the property of a substance that allows a droplet to have a contact angle of 150° or greater on its surface. Hydrophilic coatings are coatings with a water contact angle of less than 90°.

[0087] When hydrophobic structures are applied to electrosurgical devices, tissue adhesion can be reduced during the application of electrosurgical energy to treat tissue. For example, superhydrophobic textures consist of a series of micropillars that support water droplets (which could be saline or other liquids) and prevent them from adhering to the surface. In contrast, a substrate without micropillars allows water droplets to spread across the surface.

[0088] In the examples, materials such as silicones and silicone resins can be used for non-stick coatings. Suitable silicone resins for non-stick coatings include, but are not limited to, polydimethylsiloxane, polyester-modified methylphenyl polysiloxanes such as polymethylsilane and polymethylsiloxane, and hydroxyl-functionalized silicone resins. In some examples, the non-stick coating is made of a component including a siloxane, which may include hexamethyldisiloxane, tetramethylsilane, hexamethyldisilazane, or combinations thereof.

[0089] In one example, the non-stick coating is a polydimethylsiloxane (“PMDSO”) coating. In another example, the non-stick coating is a hexamethyldisiloxane (“HMDSO”) coating. In other examples, the non-stick coating is tetramethyldisiloxane (TMDSO or TMDS) and other polysiloxanes.

[0090] When HMDSO is applied to a surface, it can tend to be superhydrophobic (depending on the application setup), or at least more so than the superhydrophobic state typically achieved by the same materials or other chemical combinations of these materials applied in a non-hydrophobic pillar formation process, which do not combine to form the polymer structure. The hydrophobic pillars can be arranged in a "Kayce state" or a "Wensell state".

[0091] This disclosure includes superhydrophobic or superoleophobic articles. The article may include a substrate, such as a substrate on an electrode, actuator, or insulating disk as described herein, and a superhydrophobic or superoleophobic portion disposed on the surface of the substrate. The superhydrophobic or superoleophobic portion, the substrate, or both are substantially transparent, include color, or both. This disclosure also includes superhydrophobic or superoleophobic articles. The article includes a substrate and a superhydrophobic or superoleophobic portion disposed on the surface of the substrate. The superhydrophobic or superoleophobic portion is at least partially disposed on the surface of the substrate and includes tungsten disulfide, hexamethyldisiloxane, tetramethyldisiloxane, fluorosilane, glass, perfluoropolyether, manganese oxide polystyrene, zinc oxide polystyrene, precipitated calcium carbonate, or mixtures thereof. The superhydrophobic or superoleophobic portion also includes structural microstructures, structural nanostructures, or combinations thereof.

[0092] In one example, the non-stick coating has a substantially uniform thickness. In another example, the non-stick coating has a non-uniform thickness. In another example, the non-stick coating is discontinuous. In another example, the non-stick coating is continuous. In the examples, the electrosurgical instrument also includes an insulating layer disposed on at least a portion of the electrode, actuator, or insulating disk described herein.

[0093] In the examples, the thickness of the non-stick coating can range from 10 nm to approximately 250 nm, providing the benefit of non-stick properties. However, while non-stick characteristics can be provided, different portions of this range can offer additional benefits while still providing tissue adhesion resistance and sensing capabilities. In the examples, the non-stick coating can be a thin coating, for example, with a thickness ranging from approximately 10 nm to approximately 30 nm, but is not limited to this. In other examples, the thickness of the non-stick coating ranges from approximately 10 nm to approximately 20 nm.

[0094] The application of a non-stick coating can be accomplished using any system and process capable of precisely controlling the coating thickness. In some examples, HMDSO is deposited on electrodes, actuators, and / or insulating disks using plasma-enhanced chemical vapor deposition (PECVD) or other suitable methods, such as atmospheric pressure plasma-enhanced chemical vapor deposition (AP-PECVD). For example, the application of a polydimethylsiloxane coating can be accomplished using a system and process comprising a plasma device coupled to a power source, a source of a liquid and / or gaseous ionizable medium (e.g., oxygen), a pump, and a vacuum chamber. The power source can include any suitable component for supplying power to the plasma device or matching impedance. More specifically, the power source can be any radio frequency generator, or other suitable power source capable of generating electricity to ignite and sustain the ionizable medium to produce a plasma effluent. In examples, plasma deposition processes can be used to apply silicone and silicone resins to precisely control the thickness and withstand the heat generated during tissue sealing.

[0095] HMDSO plasma coating can be applied using a system or process comprising a plasma device coupled to a power source, an ionizable medium source, and a precursor or pre-ionization source. The power source can include any suitable component for supplying power to the plasma device or matching impedance. More specifically, the power source can be any radio frequency generator, or other suitable power source capable of generating electricity to ignite and sustain the ionizable medium to produce plasma effluent.

[0096] Plasma is generated using electrical energy delivered in continuous or pulsed mode in the form of direct current (DC) or alternating current (AC) at frequencies ranging from about 0.1 Hz to about 100 GHz, including the radio frequency band (“RF”, about 0.1 MHz to about 100 MHz) and the microwave band (“MW”, about 0.1 GHz to about 100 GHz), and using suitable generators, electrodes, and antennas. AC power can be supplied at frequencies from about 0.1 MHz to about 2450 MHz, and in embodiments from about 1 MHz to about 160 MHz. Plasma can also be ignited using continuous or pulsed direct current (DC) power or continuous or pulsed RF power, or combinations thereof. The choice of excitation frequency, workpiece, and circuitry for delivering electrical energy to the circuitry influences many characteristics and requirements of the plasma. The performance of the plasma chemical generation, gaseous or liquid feedstock delivery system, and the design of the electrical excitation circuitry are interrelated, as the choice of operating voltage, frequency, current level, and phase affects electron temperature and electron density. Furthermore, the choice of electrical excitation and plasma device hardware determines how a given plasma system dynamically responds to the introduction of new components into the main plasma gas or liquid medium. Corresponding dynamic adjustments to the electrical drive, such as via a dynamic matching network or adjustments to voltage, current, or excitation frequency, can be used to maintain controlled power transfer from the circuit to the plasma.

[0097] In one example, etching can be used to form a non-stick coating. In some examples, adhesion can be enhanced by roughening or etching a portion of the substrate that contacts the superhydrophobic or superoleophobic portion, a portion of the superhydrophobic or superoleophobic portion that contacts the substrate, or both. Roughening or etching can be accomplished using electron beam irradiation, chemical etchants (e.g., acids), or combinations thereof. method

[0098] Figure 13 This is a block diagram illustrating the operation of a method 400 for performing electrosurgical procedures using the electrosurgical device 300 of this disclosure. Method 400 may include operations 402 to 422. In this example, some of operations 402 to 422 may be omitted, and in this example, operations 402 to 422 may be performed in a different order.

[0099] At operation 402, the electrosurgical device 300 can be inserted into the anatomical structure. The electrosurgical device 300 can be sterilized in preparation for insertion. An energy source 228 and a fluid source 229 can be connected to the electrosurgical device 300. The electrosurgical device 300 can be inserted into the patient through an appropriate entry point, such as an incision or natural orifice, and, if necessary, an endoscope can be used to reach the target anatomical structure, such as... Figure 2 The target anatomical structure 206. Where desired, the electrosurgical device 300 can be navigated to the target tissue area using an endoscopic guidance system for precise placement.

[0100] At operation 404, the position of the insulating disk 306 can be set along electrode 304. Stops 356 and 358 can be adjusted to move the insulating disk 306 to the desired position. Lever 365 ( Figure 9 The insulating disk 306 can be moved forward or retracted. The position of the insulating disk 306 can be determined by referring to mark 368. In the example, the insulating disk 306 may be located approximately 2.0 mm from the farthest end face of the electrode 304. Adjusting the position of the insulating disk can control the cutting depth, thereby allowing for precise surgical incisions tailored to specific procedures.

[0101] At operation 406, one or more activation energies, such as electrical, thermal, and RF energy, can be used to power electrode 304 for the initial cut of the target tissue. The activation energy can travel from energy source 228 through conduit 226 to electrical connector 360, along control wire 340, and into electrode 304. A button, such as handle 350, can be pressed. Figure 9 Input button 21 on ) Figure 1 (To activate energy.)

[0102] At operation 408, fluid can be injected from the lumen 322 of electrode 304 onto the target tissue. The fluid can flow from fluid source 229, through line 226, through fluid port 362, through fluid tube 342, and through the lumen 322 of electrode 304 to reach the target tissue. Fluid can be sprayed from the distal end face to avoid the need to reposition electrode 304. This can be done without retracting the electrode, thus maintaining its critical position relative to the tissue. A button on handle 350 can be pressed (…). Figure 9 This activates the flow of fluid to electrode 304. If another cut is required, method 400 can proceed to operation 410. If a cut that benefits from the use of an insulated tip is required, method 400 can proceed to operation 416. If the process is complete, method 400 can proceed to operation 422.

[0103] At operation 410, the position of the insulating disk 306 on the electrode 304 can be adjusted. In the example, the position of the insulating disk 306 can be adjusted to scrape tissue from the electrode. In the example, the position of the insulating disk 306 can be adjusted to perform a second cut of the target tissue at different depths or lengths.

[0104] At operation 412, electrode 304 can be stimulated using one or more activation energies such as electrical, thermal, and RF energies to perform a second cut on the target tissue in the same manner as in operation 406.

[0105] At operation 414, fluid can be injected from the lumen 322 of electrode 304 onto the target tissue in the same manner as in operation 408. If it is necessary to benefit from cutting using an insulated tip, method 400 can proceed to operation 416. If this process is complete, method 400 can proceed to operation 422.

[0106] At operation 416, the position of the insulating disc 306 on the electrode 304 can be adjusted. In the example, the position of the insulating disc 306 can be adjusted to scrape tissue from the electrode. In the example, the position of the insulating disc 306 can be adjusted to perform a third cut of the target tissue at different depths or lengths. If desired or necessary, the insulating disc 306 can slide to its most distal position to form an insulating tip. This prevents the electrode tip from contacting and potentially damaging surrounding tissue during the procedure.

[0107] At operation 418, electrode 304 can be stimulated using one or more activation energies such as electrical, thermal, and RF energies to perform a third cut on the target tissue in the same manner as in operation 406.

[0108] At operation 420, fluid can be injected from the lumen 322 of electrode 304 into the target tissue in the same manner as in operation 408.

[0109] At operation 422, the electrosurgical device 300 can be withdrawn from the patient's anatomy, and procedural or surgical tasks can be performed, such as by withdrawing the endoscope (if in use) and closing any entry incisions in the patient's body where appropriate. The electrodes can be retracted into the sheath, and the electrosurgical device 300 can be removed from the patient's body via the endoscope (if in use).

[0110] This method utilizes the unique feature of an adjustable electrosurgical scalpel to provide a versatile and efficient tool for various surgical applications, thereby improving patient safety and surgical outcomes. Additional electrode configuration

[0111] Figure 14This is an end view of electrode 304 of this disclosure, wherein lumen 322 is omitted. Figure 4 Electrode 304 may include a body 320, a tip 324, a groove 326, and a distal end face 334. Electrode 304 may be referred to herein as... Figures 4 to 7 The described construction differs in that the lumen 322 is omitted. Electrode 304 can be externally circumscribed by circle 380. Therefore, circle 380 comprises an imaginary or virtual geometry that approximates the smallest circle in which electrode 304 can be fitted. Electrode 304 can be surrounded by an insulating disk 306, which can be fitted within a sheath 302. Omitting lumen 322 makes it easier to manufacture electrode 304. Furthermore, groove 326 can be incorporated within sheath 302 (…). Figure 4 The space within is provided for containing a tube or hose to supply fluid to the distal end of the electrode 304. The actuator 308 can be fitted within the space created by the slot 326, allowing the actuator 308 to be fitted between the circle 380 and the electrode 304, for example, within the outer periphery of the electrode 304. In this way, the size of the electrosurgical device 300 is not increased by the need to provide space between the outer periphery of the electrode 304, such as the circle 380, and the inner diameter of the sheath 302 for the actuator 308.

[0112] As described above, the electrode of this disclosure may include one or more tips or vertices, which may be used to perform cutting or other functions. The tips may form a surface with a small total area to concentrate electrical energy and other types of energy. The tips may also form gaps or spaces around which an insulating disk may be fitted, and an actuator may be fitted within the gaps or spaces to move the insulating disk. Figure 15 , Figure 16 and Figure 17 It shows what can be used as Figures 4 to 7 Additional configurations of the electrodes of this disclosure, including electrode 304.

[0113] Figure 15 This is an end view of an electrosurgical device 500 including electrode 504 and actuator 508. Electrode 504 may include body 520, tip 524, groove 526, and distal end face 534. Electrode 504 may be externally circumscribed by circle 580. Therefore, circle 580 includes an imaginary or virtual geometry that approximates the smallest circle in which electrode 504 will be fitted. As described herein, electrode 504 may be surrounded by an insulating disk (not shown) having internal grooves or openings that mate with electrode 504. The insulating disk may be fitted within a sheath 302 ( Figure 4 Additionally, electrode 540 may include a lumen (not shown) for receiving fluid. Actuator 508 may be connected to an insulating disc (not shown) configured to fit within sheath 302. Figure 4 The insulating disk contains an opening that is opposite in cross-sectional shape to that of electrode 504, and is similar to insulating disk 306 described herein. Electrode 504 may be configured to operate in a manner similar to electrode 304 described herein, but may have a different cross-sectional profile. In the example shown, electrode 504 includes a four-pointed star that forms four points 524 and four slots 526. Points 524 may include cut edges. As discussed herein, the space created by the slots 526 within the sheath 302 may allow for the inclusion of other components, such as actuator 508 or fluid conduit. Actuator 508 may be fitted within the space created by the slots 526, thereby allowing actuator 508 to be fitted between circle 580 and electrode 504, for example, within the outer perimeter of electrode 504. In this way, actuator 508 is not required to be fitted between the outer perimeter of electrode 504 (e.g., circle 580) and the sheath 302 for actuator 508. Figure 4 The space between the inner diameters of the electrodes 504 increases the size of the electrosurgical device 500. The groove 526 may have a depth D1. In different embodiments of the electrode 504, the length of the depth D1 can vary. An increased length of D1 can result in a larger groove 526, producing a larger storage space, a smaller internal area for containing the fluid lumen, and a sharper tip 524. A decreased length of D1 can result in a smaller groove 526, producing a smaller storage space, a larger internal area for containing the fluid lumen, and a blunter tip 524.

[0114] Figure 16 This is an end view of an electrosurgical device 600 including electrode 604 and actuator 608. Electrode 604 may include body 620, tip 624, facet 626, and distal end face 634. Electrode 604 may be externally circumscribed by circle 680. Therefore, circle 680 includes an imaginary or virtual geometry that approximates the smallest circle in which electrode 604 will be fitted. As described herein, electrode 604 may be surrounded by an insulating disk (not shown) having internal grooves or openings that mate with electrode 604. The insulating disk may be fitted within a sheath 302 ( Figure 4Additionally, electrode 640 may include a lumen (not shown) for receiving fluid. Actuator 608 may be connected to an insulating disk (not shown) configured to fit within sheath 602 and having a through-hole with a cross-sectional shape opposite to that of electrode 604, similar to insulating disk 306 described herein. Electrode 604 may be configured to operate similarly to electrode 604 described herein, but may have a different cross-sectional profile. In the example shown, electrode 604 includes a four-pointed square that creates four tips 624 and four facets 626. Tips 624 may include cut edges. Similar to the grooves discussed herein, facets 626 may create spaces within sheath 602. The spaces provided by facets 626 may allow for the inclusion of other components, such as actuator 608 or fluid conduits. Actuator 608 may fit within the spaces created by facets 626, thereby allowing actuator 608 to fit between circle 680 and electrode 604, for example, within the outer perimeter of electrode 604. In this way, the actuator 608 will not be required to be at the outer periphery of the electrode 604 (e.g., circle 580) and the sheath 302 for the actuator 608 ( Figure 4 The space between the inner diameters of the electrodes increases the size of the electrosurgical device 600. The facet 626 may be spaced apart from the circle 380 by a distance D2. The length of the distance D2 may be determined by the dimensions of the electrode 604 relative to the sheath 302 and the insulating disk surrounding the electrode 604. The illustrated example shows the facet 626 as flat or planar. However, in other examples, the facet 626 may be curved inwards, for example, curved into a concave surface. However, the facet 626 may be curved outwards, for example, curved into a convex surface, as shown in reference... Figure 17 To be discussed in more detail.

[0115] Figure 17This is a perspective view of an electrosurgical device 700 including an electrode 702 and an insulating disk 704. The electrode 702 may include a multi-lobed body having leaf-like portions 706 and grooves 708. In the illustrated example, the electrode 702 may include six leaf-like portions 706 and six grooves 708. The electrode 702 may include a distal end face 710. A tube 712 may extend from the proximal end through the electrode 702 to the distal end face 710. The tube 712 may include a lumen 714. The insulating disk 704 may include an outer surface 716, a notch 718, and a distal end face 720. The insulating disk 704 may be connected to an actuator 722. The leaf-like portions 607 may be formed into elongated surfaces with a small radius of curvature, which can perform cutting or other functions by concentrating electrical energy. The grooves 708 may include space for receiving other components such as the actuator 722 or a fluid tube. Furthermore, electrode 702 can be made of multiple cylindrical bodies that can be attached, for example, fused or brazed together to form an annular body, wherein leaf-like portions 706 and grooves 708 for the outer perimeter and channel 724 can be formed internally. Channel 724 can receive tube 712 to distribute fluid at the distal end of the distal end face 710. In an example, tube 712 may include a metal body to which multiple cylindrical bodies can be attached, for example, via resistance welding or another method. Insulating disk 704 may have a cutout 718 opposite in shape to electrode 702 to allow insulating disk 704 to slide along electrode 702, such as... Figure 18A , Figure 18B and Figure 18C As shown. The shape of electrode 702 and notch 718 helps to resist the twisting of insulating disk 704. benefit

[0116] The electrosurgical device 300 disclosed herein can provide the following benefits:

[0117] Central fluid injection: The knife features a central fluid injection channel, which allows fluid to be injected without retracting the electrode, thus maintaining the electrode's position relative to the anatomical structure during surgery.

[0118] Small size: Multi-pronged electrodes can provide space within the device to house actuators for the insulating disc without increasing the size of the electrosurgical apparatus. The insulating disc also keeps the overall outer diameter of the electrosurgical scalpel small. For example, the insulating disc used in this disclosure does not increase the outer diameter of the device or electrodes, whether they are in a deployed state, such as an advanced state, or in a stored state, such as a retracted state.

[0119] Adjustable cutting length: Includes a movable insulating disc that slides along the electrode, allowing surgeons to adjust the effective cutting length of the electrode, thereby enabling control of cutting depth without the need for multiple scalpels.

[0120] Insulating tip function: The movable insulating disc can also be positioned to form an insulating tip on the electrode, thereby preventing the tip from contacting the tissue and facilitating cutting along the length of the electrode without changing instruments.

[0121] Multi-directional cutting: The star-shaped or multi-tipped electrode design provides cutting edges in multiple directions, thereby enhancing the versatility and efficiency of the blade when cutting tissue.

[0122] Tissue scraping: The movable insulating disk can move forward and backward to scrape tissue off the electrode. For example, charred tissue can be removed from the electrode by moving the insulating disk.

[0123] Non-stick coating: Various coatings can be applied to electrodes or other components to prevent or inhibit tissue adhesion, which can improve the performance of the knife and reduce the risk of tissue damage.

[0124] Enhanced surgical applications: This knife can be widely used in a variety of surgical settings and procedures, including gastroenterology, general surgery, obstetrics and gynecology, otolaryngology (ENT), pulmonology, dermatology, etc.

[0125] Improved safety and convenience: The design of this knife addresses common problems with conventional electrosurgical scalpels, such as inconvenient fluid injection and the need for multiple blades, thereby potentially improving the speed, safety, and convenience of surgery. Example

[0126] Example 1 is an electrosurgical device comprising: a sheath; an electrode extending from the sheath, the electrode including a cross-sectional profile having a multi-aperture cross-sectional shape; an insulating disk positioned on the electrode at a distal end of the sheath; and an actuator connected to the insulating disk to move the insulating disk along the electrode.

[0127] In Example 2, the subject matter of Example 1 may optionally include: a multi-aperture cross-sectional shape fitted within an imaginary circle that contacts a plurality of radially outward protrusions; and an actuator fitted between an electrode and the imaginary circle.

[0128] In Example 3, the subject of any one or more of Examples 1 to 2 may optionally include, wherein the multi-top cross-sectional shape includes a square shape.

[0129] In Example 4, the subject matter of any one or more of Examples 1 to 3 may optionally include, wherein the multi-aperture cross-sectional shape comprises: a plurality of radially outward convex portions; and a plurality of radially inward concave portions, the plurality of radially inward concave portions being located between the radially outward convex portions among the plurality of radially outward convex portions.

[0130] In Example 5, the subject of Example 4 may optionally include, wherein the multi-top cross-sectional shape includes a star shape.

[0131] In Example 6, the subject of any one or more of Examples 4 to 5 may optionally include, wherein the multi-aperture cross-sectional shape includes a leaf shape.

[0132] In Example 7, the subject matter of any one or more of Examples 4 to 6 may optionally include, wherein the actuator extends within a groove of a plurality of radially recessed portions.

[0133] In Example 8, the subject matter of Example 7 may optionally include an actuator comprising a pair of elongated bodies extending in a pair of slots located on opposite sides of the electrodes.

[0134] In Example 9, the subject of Example 8 may optionally include, wherein the pair of elongated bodies comprise wires or rods.

[0135] In Example 10, the subject matter of any one or more of Examples 1 to 9 may optionally include, wherein the insulating disk includes a cutout of opposite shape having a multi-aperture cross-sectional shape, wherein an electrode extends into the cutout.

[0136] In Example 11, the subject matter of any one or more of Examples 1 to 10 may optionally include that the distal face of the electrode extends beyond the sheath by approximately 3.5 mm.

[0137] In Example 12, the subject matter of any one or more of Examples 1 to 11 may optionally include, wherein the insulating disc is fitted within the sheath.

[0138] In Example 13, the subject matter of any one or more of Examples 1 to 12 may optionally include, wherein the electrode includes a fluid passage extending through the interior of the electrode.

[0139] In Example 14, the subject matter of Example 13 may optionally include an insulating disk having a farthest surface configured to be positioned beyond the farthest surface of the electrode at the farthest position of the insulating disk while the electrode remains connected to the electrode, such that the insulating disk forms an insulating tip.

[0140] In Example 15, the subject matter of Example 14 may optionally include an insulating disc configured to be positioned adjacent to the distal end of the sheath in the nearest-end position.

[0141] In Example 16, the subject matter of Example 15 may optionally include an insulating disk configured to be positioned in a first intermediate position approximately 1.5 mm proximal to the distal end of the electrode's surface.

[0142] In Example 17, the subject of Example 16 may optionally include an insulating disk configured to be positioned in a second intermediate position approximately 2.0 mm proximal to the distal end of the electrode surface.

[0143] In Example 18, the subject of Example 17 may optionally include a controller having means for moving the insulating disk and locking the insulating disk at the farthest position, the nearest position, a first intermediate position, and a second intermediate position.

[0144] In Example 19, the subject matter of any one or more of Examples 15 to 18 may optionally include a handle comprising: a fluid port for connecting a fluid line to a fluid passage of an electrode; a flexible electrode wire extending from the electrode to the handle to connect the electrode to an enable power source; a control feature attached to an actuator to push or pull an insulating disc; and a locking mechanism for securing the actuator in one or more fixed positions.

[0145] In Example 20, the subject matter of any one or more of Examples 1 to 19 may optionally include an outer diameter of the electrode in the range of about 4.0 mm to about 5.5 mm.

[0146] In Example 21, the subject matter of any one or more of Examples 1 to 20 may optionally include, wherein: the electrode is made of stainless steel; and the insulating disk is made of ceramic.

[0147] In Example 22, the subject matter of any one or more of Examples 1 to 21 may optionally include, wherein at least one of the electrode, insulating disk, and actuator includes a non-stick surface.

[0148] In Example 23, the subject of Example 22 may optionally include, wherein the non-stick surface comprises a hydrophilic coating or a hydrophobic coating.

[0149] In Example 24, the subject matter of any or more of Examples 1 to 23 may optionally include an enabled energy generator electrically connected to electrodes.

[0150] In Example 25, the subject matter of Example 24 may optionally include, wherein the actuator is electrically connected to the electrode.

[0151] Example 26 is a method for performing surgery on tissue, the method comprising: inserting an insert sheath into an anatomical structure to position an electrode close to a target tissue; adjusting an insulating disk connected to the electrode to adjust the distance between the distal end face of the electrode and the insulating disk; and providing energy to the electrode to cut the target tissue.

[0152] In Example 27, the subject of Example 26 may optionally include injecting fluid into target tissue through a fluid passage extending through an electrode.

[0153] In Example 28, the subject of Example 27 may optionally include spraying fluid from the farthest end face of the electrode.

[0154] In Example 29, the subject matter of any or more of Examples 26 to 28 may optionally include cutting target tissue using the edge of an electrode, wherein the electrode has a cross-sectional profile with a forked shape, the forked shape including a plurality of tips and a plurality of grooves.

[0155] In Example 30, the subject of Example 29 may optionally include cutting target tissue in different radial directions using multiple edges of an electrode.

[0156] In Example 31, the subject matter of any or more of Examples 26 to 30 may optionally include pulling or pushing a rod or wire to adjust the position of the insulating disc.

[0157] In Example 32, the subject of Example 31 may optionally include lever actuation on a handle connected to the insert sheath to pull or push a rod or wire.

[0158] In Example 33, the subject matter of any or more of Examples 31 to 32 may optionally include locking the position of the insulating disk.

[0159] In Example 34, the subject matter of Example 33 may optionally include, wherein locking the position of the insulating disc includes rotating a stop knob to prevent axial displacement of the rod or wire.

[0160] In Example 35, the subject matter of any or more of Examples 26 to 34 may optionally include scraping tissue from an electrode by moving an insulating disk along the electrode.

[0161] In Example 36, the subject matter of any or more of Examples 26 to 35 may optionally include using a non-stick surface of the electrode to prevent tissue from adhering to the electrode.

[0162] Each of these non-restrictive examples can exist independently, or can be combined with one or more examples from other examples in various permutations or combinations. Precautions

[0163] The detailed description above includes reference to the accompanying drawings that form part of the detailed description. The drawings illustrate, by way of illustration, specific embodiments in which the invention may be practiced. These embodiments are also referred to herein as “examples.” Such examples may include elements other than those shown or described. However, the inventors also contemplate examples in which only those elements shown or described are provided. Furthermore, the inventors contemplate examples using any combination or arrangement of those elements (or one or more aspects of those elements) shown or described with respect to a particular example (or one or more aspects of that particular example) or with respect to other examples shown or described herein (or one or more aspects of those other examples).

[0164] In this document, as is common in patent documents, the terms "a" or "one" are used to include one or more, regardless of any other instance or use of "at least one" or "one or more". In this document, unless otherwise indicated, the term "or" is used to mean a non-exclusive "or", such that "A or B" includes "A but not B", "B but not A", and "A and B". In this document, the terms "comprising" and "in" are used as concise equivalents to the corresponding terms "including" and "wherein". Furthermore, in the appended claims, the terms "including" and "comprising" are open-ended, meaning that a system, apparatus, article, composition, formulation, or treatment that includes elements other than those listed after such terms in the claim is still considered to fall within the scope of that claim. Additionally, in the following claims, the terms "first", "second", and "third", etc., are used merely as designations and are not intended to impose numerical requirements on their objects.

[0165] The method examples described herein may be implemented, at least in part, by a machine or computer. Some examples may include computer-readable or machine-readable media encoded with instructions operable to configure electronic devices to perform the methods described in the examples above. Implementations of such methods may include code, such as microcode, assembly language code, higher-level language code, etc. Such code may include computer-readable instructions for performing various methods. The code may form parts of a computer program product. Furthermore, in the examples, such as during execution or at other times, the code may be tangibly stored on one or more volatile, non-transitory, or non-volatile tangible computer-readable media. Examples of such tangible computer-readable media may include, but are not limited to, hard disks, removable disks, removable optical discs (e.g., compact discs and digital video discs), magnetic tape cartridges, memory cards or sticks, random access memory (RAM), read-only memory (ROM), etc.

[0166] The above description is intended to be illustrative and not restrictive. For example, the examples described above (or one or more aspects of the examples described above) can be used in combination with each other. For example, other embodiments can be used by those skilled in the art after consulting the above description. An abstract is provided to enable the reader to quickly determine the nature of the technical disclosure. The abstract is submitted based on the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Furthermore, in the detailed description above, various features may be combined to simplify this disclosure. This should not be construed as implying that any unclaimed disclosed feature is necessary for any claim. Rather, the subject matter of the invention may lie in all features of fewer than the embodiments of a particular disclosure. Therefore, the appended claims are incorporated herein by way of example or embodiment, wherein each claim exists independently as a separate embodiment, and it is contemplated that such embodiments may be combined with each other in various combinations or arrangements. The scope of the invention should be determined by reference to the appended claims and the full scope of the equivalents conferred by such claims.

Claims

1. An electrosurgical device, comprising: jacket; Electrodes, extending from the sheath, the electrodes comprising: A cross-sectional profile having a multi-apex cross-sectional shape; An insulating disk, the insulating disk being positioned on the electrode at the distal end of the sheath; and An actuator connected to the insulating disk to move the insulating disk along the electrode.

2. The electrosurgical device according to claim 1, wherein: The multi-apex cross-sectional shape is fitted within an imaginary circle that contacts the apex of the multi-apex cross-sectional shape; and The actuator is mounted between the electrode and the imaginary circle.

3. The electrosurgical device of claim 1, wherein, The multi-apex cross-sectional shape includes a square shape.

4. The electrosurgical device according to claim 1, wherein, The multi-apex cross-sectional shape includes: Multiple radially outward protrusions; and Multiple radially recessed portions, wherein the multiple radially recessed portions are located between the multiple radially convex portions.

5. The electrosurgical device according to claim 4, wherein, The multi-apex cross-sectional shape includes a star shape.

6. The electrosurgical device according to claim 4, wherein, The multi-apex cross-sectional shape includes a leaf-like shape.

7. The electrosurgical device according to claim 4, wherein, The actuator extends within the grooves of the plurality of radially recessed portions.

8. The electrosurgical device according to claim 7, wherein, The actuator includes a pair of elongated bodies extending in a pair of slots located on opposite sides of the electrodes.

9. The electrosurgical device according to claim 8, wherein, The pair of elongated bodies include wires or rods.

10. The electrosurgical device according to claim 1, wherein, The insulating disk includes a cutout having a shape opposite to the cross-sectional shape of the multi-aperture, wherein the electrode extends into the cutout.

11. The electrosurgical device according to claim 1, wherein, The distal end face of the electrode extends beyond the sheath by approximately 3.5 mm.

12. The electrosurgical device according to claim 1, wherein, The insulating disc is fitted inside the sheath.

13. The electrosurgical device according to claim 1, wherein, The electrode includes a fluid passage extending through the interior of the electrode.

14. The electrosurgical device according to claim 13, wherein, The insulating disk has a farthest surface configured to be positioned beyond the farthest surface of the electrode at the farthest position of the insulating disk while the electrode remains connected to the electrode, such that the insulating disk forms an insulating tip.

15. The electrosurgical device according to claim 14, wherein, The insulating disc is configured to be positioned in the nearest-end position adjacent to the far end of the sheath.

16. The electrosurgical device according to claim 15, wherein, The insulating disk is configured to be positioned in a first intermediate position approximately 1.5 mm proximal to the farthest surface of the electrode.

17. The electrosurgical device according to claim 16, wherein, The insulating disk is configured to be positioned in a second intermediate position approximately 2.0 mm proximal to the farthest surface of the electrode.

18. The electrosurgical device of claim 17, further comprising a controller having means for moving the insulating disk and locking the insulating disk at the farthest position, the nearest position, the first intermediate position, and the second intermediate position.

19. The electrosurgical device of claim 15, further comprising a handle, the handle comprising: A fluid port for connecting a fluid line to the fluid passage of the electrode; A flexible electrode wire extending from the electrode to the handle to connect the electrode to an enable power source; A control feature, attached to the actuator, for pushing or pulling the insulating disk; and A locking mechanism that secures the actuator in one or more fixed positions.

20. The electrosurgical device according to claim 1, wherein, The outer diameter of the electrode is in the range of approximately 4.0 mm to approximately 5.5 mm.

21. The electrosurgical device according to claim 1, wherein: The electrode is made of stainless steel; and The insulating disk is made of ceramic.

22. The electrosurgical device according to claim 1, wherein, At least one of the electrode, the insulating disk, and the actuator includes a non-stick surface.

23. The electrosurgical device according to claim 22, wherein, The non-stick surface includes a hydrophilic coating or a hydrophobic coating.

24. The electrosurgical device of claim 1, further comprising an activation energy generator electrically connected to the electrode.

25. The electrosurgical device according to claim 24, wherein, The actuator is electrically connected to the electrode.

26. A method for performing a surgical procedure on tissue, the method comprising the steps of: Insert the insert sheath into the anatomical structure to position the electrode close to the target tissue; The insulating disk connected to the electrode is adjusted to adjust the distance between the farthest end face of the electrode and the insulating disk; and Energy is supplied to the electrode to cut the target tissue.

27. The method of claim 26, further comprising injecting fluid into the target tissue through a fluid passage extending through the electrode.

28. The method of claim 27, further comprising spraying the fluid from the farthest end face of the electrode.

29. The method of claim 26, further comprising cutting the target tissue using the edge of the electrode, wherein, The electrode has a cross-sectional profile with a multi-pronged shape, the multi-pronged shape including multiple tips and multiple grooves.

30. The method of claim 29, further comprising cutting the target tissue along different radial directions using a plurality of edges of the electrode.

31. The method of claim 26 further includes pulling or pushing a rod or wire to adjust the position of the insulating disc.

32. The method of claim 31, further comprising: A lever located on a handle connected to the insert sheath is actuated to pull or push the rod or the wire.

33. The method of claim 31 further includes locking the position of the insulating disk.

34. The method according to claim 33, wherein, Locking the position of the insulating disc includes rotating the stop knob to prevent axial displacement of the rod or the wire.

35. The method of claim 26, further comprising scraping tissue off the electrode by moving the insulating disk along the electrode.

36. The method of claim 26, further comprising using a non-stick surface of the electrode to prevent tissue from adhering to the electrode.

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