Bipolar electrosurgical instruments for remote control in medical and surgical applications and methods for manufacturing the same

Abstract

A bipolar electrosurgical instrument (1) comprising an articulated end (2) having a support link (10) and two tips (21, 22) having electrically conductive bodies, the two tips being articulated to the support link (10) and movable toward / away from each other; wherein the support link (10) has a multilayer structure comprising two electrical conductors (11, 12) and at least one electrical insulator (20) between them, and each electrical conductor (11, 12) of the support link is connected to the respective tip ( The chip (21, 22) is provided with support portions (13, 14) that receive the chip in an energized state, thereby defining a first conductive outward path and a second separate conductive return path through the electrically conductive body of the chip (21, 22) and the electrical conductor of the support link (10); the support link (10) defines two rotary joints (PJ, DJ) having mutually orthogonal axes (PP, YY), and each of the two rotary joints comprises the multilayer structure in which the electrical insulator (20) is interposed between the two electrical conductors (11, 12).

Description

Technical Field

[0001] The present invention relates to an electrosurgical instrument.

[0002] In particular, the present invention is directed to a bipolar electrosurgical instrument.

[0003] The present invention further relates to a robotic system for medical or surgical remote operation comprising an instrument.

[0004] Furthermore, the present invention relates to a method for manufacturing an instrument.

[0005] The present invention further relates to an electrical insulation assembly for an electrosurgical instrument.

Background Art

[0006] Robotic surgical devices are generally known in the art and typically comprise a central robotic tower and one or more robotic arms extending from the central robotic tower. Each arm comprises an electric positioning system (or manipulator) for moving a surgical instrument that can be detachably attached distally thereto in order to perform a surgical procedure on a patient. The patient is usually lying on an operating table placed in an operating room, where a sterile state is ensured in order to avoid bacterial contamination by the non-sterile parts of the robotic device.

[0007] Generally, known surgical instruments for remote-operated robotic surgery comprise a proximal transmission interface (the "backend" in terms commonly used in the art) having an interface intended to be actuated by a robotic manipulator. From the proximal interface, an elongated element such as a rod or a shaft extends, and at its distal end, an articulating device (e.g., a robotic cuff) having an actuating end part (e.g., a needle holder, scissors, dilator, scalpel) is provided.

[0008] In known surgical instruments having an articular cuff, the articular cuff typically consists of multiple links, which are moved by multiple tendons (or actuating cables). One or more terminal links have free ends that form the aforementioned actuating terminals and are adapted, for example, to act directly on the patient's anatomical structure and to handle needles and sutures for performing anastomoses or other surgical procedures.

[0009] Unlike known surgical instruments with articular cuffs, surgical instruments with "snake" type articular devices are also known, which consist of multiple stacked vertebrae that are movable relative to one another and are actuated by multiple actuating cables or tendons.

[0010] For example, US-10582975 and WO-2018-189721, under the name of the same applicant, disclose various embodiments of surgical instruments for robotic surgery and microsurgery, which are designed to be subject to extreme miniaturization of joint cuffs, and by extension, the working terminals or end effectors, and the links forming the end effectors are manufactured by wire electrical discharge machining.

[0011] Surgical instruments adapted to transmit electricity to tissue, such as electrocautery instruments for robotic surgery, are also known. Some known examples of such instruments are shown in prior art documents US-6840938, US-7824401, US-10376331, US-8398634, US-10716617, and US-2022-133388.

[0012] Known electrosurgical instruments typically have one or more conductors for transmitting electricity from a robotic manipulator, which then transmits the electricity to the articulated end of the instrument's end effector via a transmission interface portion of the surgical instrument.

[0013] Such articulated electrosurgical instruments are typically made of electrically non-conductive materials, preferably materials with high thermal stability and insulators such as non-conductive plastics (e.g., ULTEM) or ceramics, with only the conductive metal ends to which the electrically conductive cables terminate being excluded.

[0014] If all the articulated components of the end effector are made of metal, and the idler or fixed pulley is also made of metal, and the motion actuating strand is made of steel or tungsten, there is a risk of insufficient electrical insulation and the possibility that voltage may be transmitted through the actuating cable to the entire articulated end and even to the posterior proximal transmission interface ("backend"). Also for these reasons, the active articulated ends of such known electrosurgical instruments are usually quite large and not suitable for miniaturization.

[0015] To electrically insulate the articulated ends of such active electrosurgical instruments, an insulating sleeve is typically fitted around the entire end effector, thereby forming an electrical insulation barrier between the end effector itself and the patient's tissues in its vicinity or in contact with it.

[0016] In particular, in known electrocautery applications in laparoscopic surgery, it is crucial to avoid electrical conduction at the fulcrum, i.e., the insertion point where the surgical instrument is inserted into its designated opening. The fulcrum represents the center of rotation of the positioning rod or shaft relative to the patient under operating conditions. For this reason, the positioning shaft itself is manufactured from an electrically insulating material or covered with an insulating layer (e.g., rubber) to avoid arcing with the abdominal wall.

[0017] Such articulated electrosurgical instruments, particularly in endoscopic or minimally invasive applications, have a hollow positioning shaft made of non-conductive plastic or composite material to avoid unwanted lateral discharge, and only electrically conductive cables extending within a specific channel inside the shaft connect to a metal application terminal (e.g., "jaws") to transmit potential.

[0018] In fact, monopolar electrosurgical instruments typically have an electrical cable that extends from the transmission interface ("backend") to the joint cuff within the instrument's positioning rod or shaft. The positioning shaft is usually made of an electrically insulating material, while the working tip of the electrosurgical instrument is electrically active and made of metal. In such known monopolar electrosurgical instruments, the electrical circuit is closed by a return electrode (usually a plate) after passing through a part of the patient's body.

[0019] In contrast, in bipolar electrosurgical instruments, the two tips of the instrument are polarized with different charges, thereby forming two electrodes, one of which forms the return electrode. In this type of electrosurgical instrument, it is necessary to avoid short circuits in various parts of the end effector that have different charges (for example, between the two tips and between their respective electrical conductors).

[0020] Furthermore, to avoid unintended electrical supply from areas other than the terminal, it is also known to use an electrical insulating sleeve attached to the joint cuff (in both monopolar and bipolar devices).

[0021] Known solutions for bipolar electrosurgical instruments are not suitable for extreme miniaturization at the articulated end level because there are various components that need to be assembled, such as electrical conduction means for polarizing the tip ("jaws") with opposite charges, electrical insulation means, return pulleys, and articulated end actuation cables.

[0022] Terminating or bonding conductive electrical cables to the tip end links of miniaturized surgical instruments is technically complex.

[0023] The rigidity and size of the conductor cable connected to the tip of the jaw or articulated end impair the motion, opening / closing, and gripping performance, especially in miniaturized devices.

[0024] Therefore, there is a felt need to propose a bipolar electrosurgical instrument suitable for extreme miniaturization.

Summary of the Invention

[0025] (Solution Means) The object of the present invention is to eliminate the drawbacks pointed out with respect to the prior art and to propose a solution to the above-mentioned needs.

[0026] According to the present invention, the object and other objects are achieved by the electrosurgical instrument according to claim 1, the robotic system according to claim 14, the manufacturing method according to claim 15, the electrosurgical instrument according to claim 17 or 18, the insulation assembly according to claim 19, and the assembly method according to claim 20.

[0027] Some advantageous embodiments are the subject of the dependent claims.

[0028] According to one aspect of the present invention, a bipolar electrosurgical instrument includes an articulated end portion having a support link, a first chip movable with respect to the support link and having an electrical conductor with its operative portion, and a second chip movable with respect to the support link and having an electrical conductor with its operative portion.

[0029] The operative portion of the chip can be a gripping surface and / or a cutting surface, and / or a free end, for example a sharp free end.

[0030] The operative portion of the first chip and the operative portion of the second chip are movable in a direction towards each other / away from each other. Thereby, the operative portions of the chips can be operable to open and close with respect to each other.

[0031] The support link has a multilayer structure formed by a first electrical conductor, a second electrical conductor, and at least one electrical insulator therebetween.

[0032] The first electrical conductor of the support link has a first support portion, and the first chip is attached to the first support portion in a state of energization with it, thereby forming a first conductive path, for example, a conductive forward path toward the working portion of the first chip.

[0033] The second electrical conductor of the same support link has a second support portion, and the second chip is attached to the second support portion in a state of energization with it, thereby forming a second conductive path, for example, a conductive return path from the working portion of the second chip.

[0034] By providing a first conductive path and a second conductive path, it is possible to close an electrical circuit through the body of the bipolar surgical instrument, particularly through its articulated end which has a support link having a multilayer structure including an electrical insulating layer between two tips and two electrical conductor layers.

[0035] The first conductive forward path and the second conductive return path are distinct from each other and are separated from each other within the body of the support link by at least one electrical insulator.

[0036] Each support portion of the support link may have at least one prong, preferably two, made of an electrically conductive material.

[0037] Preferably, the support link lacks internal degrees of freedom.

[0038] The rotation axes of the chips are preferably aligned with each other. In one embodiment, the rotation axes of the chips are parallel to each other and spaced a certain distance apart.

[0039] The articulated end may have other degrees of freedom, and the support link itself can be articulated to a positioning shaft or rod of a bipolar electrosurgical instrument while maintaining electrical insulation between the electrical conductors. In one embodiment, the first electrical conductor of the support link has a first proximal support portion, and the second electrical conductor of the support link has a second proximal support portion, and the first and second proximal support portions cooperate to define a proximal rotational joint of the articulated end having a multilayer structure formed by two electrical conductors and an electrical insulator between them.

[0040] The proximal rotational joint preferably has a proximal rotational axis perpendicular to the rotational axis that articulates the tip to the support link, thereby continuously defining a multilayer structure formed by two electrical conductors and an electrical insulator between them in two orthogonal directions.

[0041] The support links may be manufactured by wire electrical discharge machining of a workpiece made of a multilayer material.

[0042] The support links may be manufactured by assembling separate parts; for example, the electrical insulator may be manufactured by molding and the electrical conductor by wire electrical discharge machining.

[0043] Manufacturing by wire electrical discharge machining allows for the formation of sliding surfaces for the actuarials of at least one tip of the articulated end. Thus, according to one embodiment, each electrical conductor comprises at least two sliding surfaces for the actuarials of the corresponding tip; all sliding surfaces are convex wire-woven surfaces having parallel generatrixes, the parallel generatrix of one sliding surface being perpendicular to the parallel generatrix of the other of the two sliding surfaces. Preferably, the parallel generatrix of one sliding surface is parallel to the axis of rotation of the proximal rotatoric joint, and the parallel generatrix of the other sliding surface is parallel to the axis of rotation of the distal rotatoric joint of the articulated end of the bipolar electrosurgical instrument.

[0044] The electrical insulator of the support link may have a plate-like portion extending between the tips of the articulated end and a proximal support portion. According to one embodiment, the electrical insulator, in particular its proximal support portion, comprises at least two sliding surfaces (for the working tendon), all of which are convex wire-woven surfaces having parallel generatrixes, the parallel generatrixes of one sliding surface being perpendicular to the parallel generatrixes of the other sliding surface.

[0045] According to one embodiment, the two electrical conductors of the support link are manufactured by wire electrical discharge machining using two orthogonal and substantially identical shaping cuts, thereby obtaining two substantially identical electrical conductors; preferably, the two electrical conductors are manufactured as separate parts and then assembled into an electrical insulator.

[0046] According to one aspect of the present invention, a method for assembling a support link for an electrosurgical instrument may be provided, the assembly method comprising the steps of: providing two electrical conductors each having a plane and an electrical insulator having two opposing planes; sliding the electrical insulator relative to the first electrical conductor such that one plane of the electrical insulator slides on the plane of the first electrical conductor; and sliding the plane of the second electrical conductor on the opposite plane of the electrical insulator. The electrical conductors are preferably manufactured by wire electrical discharge machining. Each planar portion of the electrical conductor is preferably formed by prongs of their support portions.

[0047] According to one aspect of the present invention, a support link comprises two support portions, each receiving two tips; the two tips are arranged in alignment to form a rotating pin joint comprising a pin assembly comprising a first electrically conductive half-pin energized with a first electrical conductor and a first tip, and a second electrically conductive half-pin energized with a second electrical conductor and a second tip, wherein an electrical insulating element such as a gap, air, or a glass sphere is provided between the first and second half-pins. The term "half-pin" is not necessarily intended to refer to half of a pin, for example, a portion of the pin corresponding to half of its longitudinal extension.

[0048] According to one embodiment, the first half-pin and the second half-pin are manufactured separately from each other.

[0049] According to one embodiment, the first half-pin and the second half-pin are separated parts of the same component (pin). According to one embodiment, the articulated pin comprises a coating having a first electrically conductive portion, a second electrically conductive portion, and a third electrically insulating portion arranged longitudinally between them.

[0050] According to one aspect of the present invention, the positioning rod or shaft comprises two coaxially arranged rigid electrical conductors, thereby autonomously forming a portion of two separate conductive forward and conductive return paths. For example, the two coaxial rigid bodies may be two steel cylinders.

[0051] According to one aspect of the present invention, a bipolar electrosurgical instrument comprises a positioning rod having a distal portion and an articulated end connected to the distal portion of the rod, the articulated end comprising two tips having electrical conductors, the two tips being articulated to the distal portion of the positioning rod and movable toward each other / away from each other; the two tips are intended to be polarized with different charges; the positioning rod comprises two electrical conductors arranged coaxially with each other, thereby forming two separate conductive paths, each of the two separate conductive paths of the positioning rod being energized with respect to the tips.

[0052] The positioning rod may be associated with the articulated end as described above, thereby forming two separate conductive forward and return paths for the bipolar electrosurgical instrument through the body of the positioning rod and the body of the articulated end.

[0053] According to one aspect of the present invention, a method for manufacturing a support link for an electrosurgical instrument by wire electrical discharge machining is provided, the method comprising the steps of: (i) providing a composite workpiece comprising a first electrical conductor, a second electrical conductor and a cavity between them, and arranging an electrically insulating epoxy resin in the cavity; (ii) mounting the composite workpiece to a wire electrical discharge machine equipped with a cutting wire; and (iii) performing a first shaping through cut on the workpiece made of the composite material using the cutting wire to form a through seat for an articulating pin.

[0054] The method may further include the steps of rotating the composite workpiece relative to the cutting wire and performing a second forming through-cut on the same composite workpiece to form a second through-seat for the second articulated pin.

[0055] For example, the support link is manufactured by wire electrical discharge machining using two mutually orthogonal shaping cuts, and the electrical insulator is fixed to the electrical conductor in the form of an adhesive resin before any shaping cuts are performed, thereby forming a composite workpiece. Preferably, the electrical insulator has an inclined unfolding portion that is not parallel to either the axis of rotation of the proximal or distal rotator joint, for example, the inclined unfolding portion is located near or at the proximal rotator joint.

[0056] According to one aspect of the present invention, an electrical insulation assembly is provided for separating two conductive paths of an articulated end of a bipolar electrosurgical instrument. The articulated end is preferably a miniaturized articulated end suitable for microsurgery. The articulated end defines at least two rotary pin joints, each rotary pin joint comprising a pin assembly having two electrically conductive half-pins, and the electrical insulation assembly comprising an electrical insulator defining two orthogonal pin joints of the at least two rotary pin joints in a single component, and an electrical insulation element interposed between the two half-pins. The electrical insulation element and the two electrically conductive half-pins may belong to the same pin component and may take the form of, for example, a selective insulating / conductive coating on the longitudinal body of the articulated pin.

[0057] (Brief explanation of the drawing) Further features and advantages of the present invention will become apparent from the following description of preferred embodiments, shown as non-limiting examples, with reference to the accompanying drawings, which are briefly described below. In this disclosure, the reference to “one embodiment” does not necessarily refer to the same embodiment, but should be understood to mean at least one embodiment. Also, for reasons of brevity and to reduce the total number of figures, some figures may be used to illustrate features of multiple embodiments, and not all elements of a figure are necessary for a particular embodiment. [Brief explanation of the drawing]

[0058] [Figure 1A] Figure 1A is an operational diagram of a bipolar electrosurgical device according to one embodiment. [Figure 1B] Figure 1B is a perspective view of a robotic system for medical or surgical remote control. [Figure 2A] Figure 2A is a perspective view of a bipolar electrosurgical instrument according to one embodiment. [Figure 2B] Figure 2B shows the details indicated by circle B in Figure 2A. [Figure 3A] Figure 3A is a perspective view of the articulated end of a bipolar electrosurgical instrument according to one embodiment, with some parts omitted for clarity. [Figure 3B] Figure 3B is a front view obtained according to the viewpoints indicated by arrows B and C in Figure 3A, respectively. [Figure 3C] Figure 3C is a front view obtained according to the viewpoints indicated by arrows B and C in Figure 3A, respectively. [Figure 3D] Figure 3D is a cross-sectional view obtained along the cross-section indicated by arrow DD in Figure 3C. [Figure 3E] Figure 3E is a cross-sectional view obtained along the cross-section indicated by arrow EE in Figure 3B. [Figure 4A]Figure 4A is a perspective view of the articulated end of a bipolar electrosurgical instrument according to one embodiment, with some parts omitted for clarity. [Figure 4B] Figure 4B is a perspective cross-sectional view of the articulated end of Figure 4A. [Figure 4C] Figure 4C is a perspective cross-sectional view of the articulated end of Figure 4A. [Figure 5A] Figure 5A is a front view of the articulated end of a bipolar electrosurgical instrument according to one embodiment, with some parts omitted for clarity. [Figure 5B] Figure 5B is a cross-sectional view obtained along the cross-section indicated by arrow BB in Figure 5A. [Figure 5C] Figure 5C is a front view obtained according to the viewpoint indicated by arrow C in Figure 3A. [Figure 5D] Figure 5D is a cross-sectional view obtained along the cross-section indicated by arrow DD in Figure 5C. [Figure 6A] Figure 6A is a perspective view of a segment of a positioning rod or shaft according to one embodiment, with some parts drawn with dashed lines for clarity. [Figure 6B] Figure 6B is a longitudinal cross-sectional view of a positioning rod or shaft according to one embodiment. [Figure 6C] Figure 6C is a schematic diagram showing a positioning rod or shaft according to one embodiment. [Figure 6D] Figure 6D is a perspective view of a proximal link according to one embodiment. [Figure 7A] Figure 7A is a perspective view of a support link according to one embodiment. [Figure 7B] Figure 7B is an exploded perspective view of the support link in Figure 7A. [Figure 8A] Figure 8A is a front view of a support link according to one embodiment. [Figure 8B] Figure 8B is a front view following the viewpoint indicated by arrow B in Figure 8A. [Figure 8C] Figure 8C is an exploded perspective view of the support link in Figure 8A. [Figure 9A] Figure 9A is an exploded perspective view of several electrical conductor portions of a support link according to one embodiment. [Figure 9B] Figure 9B is a front view of the electrical conductor of the support link in Figure 9A. [Figure 9C] Figure 9C is a front view obtained according to the viewpoint indicated by arrow C in Figure 9B. [Figure 10] Figure 10 is a perspective view of the electrical insulator of a support link according to one embodiment. [Figure 11] Figure 11 is a perspective view of a chip or chip link according to one embodiment. [Figure 12A] Figure 12A is a cross-sectional view of a distal rotational joint comprising an articular pin assembly according to one embodiment. [Figure 12B] Figure 12B is a cross-sectional view of a proximal rotational joint comprising an articular pin assembly according to one embodiment. [Figure 13] Figure 13 is a cross-sectional view of a distal rotational joint comprising an articular pin assembly according to one embodiment. [Figure 14A] Figure 14A is a perspective view of the articulated end of a bipolar electrosurgical instrument according to one embodiment. [Figure 14B] Figure 14B is a front view of the articulated end of Figure 14A, obtained according to the viewpoint indicated by arrow B in Figure 14A. [Figure 14C] Figure 14C is a view following the viewpoint indicated by arrow C in Figure 14B. [Figure 14D] Figure 14D is a cross-sectional view obtained along the cross-section indicated by arrow DD in Figure 14C. [Figure 14E] Figure 14E is a longitudinal cross-sectional view obtained along the cross-section indicated by arrow EE in Figure 14C. [Figure 14F] Figure 14F is a cross-sectional view obtained along the cross-section indicated by arrow FF in Figure 14C. [Figure 15A] Figure 15A is an exploded view of a workpiece according to one embodiment. [Figure 15B] Figure 15B is a plan view of the workpiece shown in Figure 15A, illustrating the cutting profile to be created. [Figure 15C] Figure 15C is a plan view obtained according to the viewpoint indicated by arrow C in Figure 15B. [Figure 16A] Figure 16A shows a support link according to one embodiment, obtained from the workpiece in Figure 15B. [Figure 16B] Figure 16B shows a support link according to one embodiment. [Figure 17] Figure 17 is a schematic diagram showing a wire electrical discharge machining machine equipped with a cutting wire according to one embodiment. [Figure 18A] Figure 18A is a schematic cross-sectional view of the articulated end of a bipolar electrosurgical instrument according to one embodiment. [Figure 18B] Figure 18B is a schematic cross-sectional view of the articulated end of a bipolar electrosurgical instrument according to one embodiment. [Figure 19] Figure 19 is a perspective view of the support link of the articulated end of a bipolar electrosurgical instrument according to one embodiment. [Figure 20] Figure 20 is a schematic cross-sectional view of an articulated pin according to one embodiment. [Modes for carrying out the invention]

[0059] (Detailed description of several embodiments) Throughout this specification, references to “one embodiment” mean that certain features, structures, or functions described in relation to an embodiment are included in at least one embodiment of the present invention. Therefore, expressions such as “in one embodiment” in various parts of this specification do not necessarily all refer to the same embodiment. Furthermore, certain features, structures, or functions, as shown in different drawings, can be combined in any suitable manner in one or more embodiments.

[0060] According to one embodiment, a bipolar electrosurgical instrument 1 (or instrument 1) is provided.

[0061] The bipolar electrosurgical instrument 1 is preferably suitable for a robotic system 100 for medical or surgical remote control.

[0062] The bipolar electrosurgical instrument 1 comprises an articulated end 2. Preferably, the bipolar electrosurgical instrument 1 comprises a positioning rod or shaft 3 and an articulated end 2 connected to a distal portion 34 of the positioning rod or shaft. The bipolar electrosurgical instrument 1 preferably further comprises a proximal transmission interface portion 4 ("backend") for operational connection with a robotic manipulator 5 of a robotic system 100 for medical or surgical remote operation. The proximal transmission interface portion 4 of the instrument 1 may comprise a connector 6 for receiving a bipolar cable, the other end of which is connected to an electrosurgical generator 17. The electrosurgical generator 17 is preferably then connected to a foot switch 18 located near or at the master control station 9 of the robotic system 100 for medical or surgical remote operation. The patient 8 lies on a bed 7 or operating table 7, which may be located near the master control station 9. The bipolar connector 6 preferably comprises two separate conductive paths, which may be separated by an electrical insulating layer interposed between them.

[0063] The articulated end 2 of the device comprises a support link 10 and two tips 21, 22 (or tip links, or jaws) articulated to the support link 10 and movable toward / away from the support link 10 (e.g., opening / closing direction). Thus, the articulated end comprises a first tip 21 (tip link, jaw) and a second tip 22 (tip link, jaw) that are movable toward / away from each other.

[0064] Each of the two tips 21 or 22 of the bipolar electrosurgical instrument 1 is polarized with a different charge from the other tip, for example, opposite charges, i.e., positive-negative, by providing two separate conductive paths that extend separately through the articulated end 2. For example, the first tip 21 is polarized with a positive charge and the second tip 22 is polarized with a negative charge. Each conductive path extends through the articulated end 2 and preferably further extends through a positioning rod or shaft 3.

[0065] Advantageously, the support link 10 comprises a multilayer structure including two electrical conductors 11, 12 and at least one electrical insulator 20 interposed between them. Thus, the two electrical conductors 11, 12, including a first electrical conductor 11 and a second electrical conductor 12, are separated by the electrical insulator 20 interposed between them and are adapted to be polarized with different charges, for example, opposite charges. The electrical insulator 20 is formed of, for example, a ceramic material.

[0066] More advantageously, each electrical conductor 11, 12 of the support link 10 has support portions 13, 14 that are energized with the respective tips 21, 22 of the two tips. In other words, the first electrical conductor 11 of the support link 10 has a first support portion 13 ("clevis"), for example, comprising two prongs, and the first tip 21 is attached to the first support portion 13 of the first electrical conductor 11, and the second electrical conductor 12 of the support link 10 has a second support portion 14 ("clevis"), for example, comprising two prongs, and the second tip 22 is attached to the second support portion 14 of the second electrical conductor 12.

[0067] The support link 10 comprises two electrical conductors 11 and 12 separated from each other by an electrical insulator 20, and each electrical conductor 11 and 12 is energized with the respective tips 21 and 22 of the two tips of the articulated end 2, thereby enabling the formation of two separate conductive paths at the articulated end 2.

[0068] At the same time, the need to provide conductive cables (e.g., electric wires) embedded or incorporated within the body of the support link is avoided. This is because the structure of the support link itself forms two separate and isolated conductive paths.

[0069] Therefore, by electrically activating the two electrical conductors 11 and 12 of the support link 10, it is possible to electrically activate the two tips 21 and 22 of the bipolar device 1. For example, for this purpose, conductive cables terminated to each of the two electrical conductors can be provided. If two separate conductive paths are also provided on the positioning rod or shaft 3, then, for example, the two tips 21 and 22 of the bipolar device 1 can be electrically activated by conductive cables terminated on the positioning rod or shaft 3.

[0070] In a preferred embodiment, the support link 10 has no internal degrees of freedom. In other words, the two electrical conductors 11 and 12 are fixed together to an electrical insulator 20 interposed between them, while maintaining separation from each other throughout the entire volume of the support link 10. Fixing the electrical conductors 11 and 12 to the electrical insulator 20 can be done in various ways, for example, by bonding and / or welding. In one embodiment, fixing is done by fitting. In another embodiment, fixing is done by providing articulating pins in combination with bonding.

[0071] Preferably, each tip 21, 22 comprises its respective working portion 23, 24, free end 25, and mounting base 27, 28, each mounting base 27, 28 articulated to a support link 10 (e.g., each support portion 13 or 14) and forming an energized connection with it. For example, each support portion 13 and 14 comprises two prongs ("clevis"), and each mounting base 27, 28, substantially having the form of a disc, is inserted between the two prongs of an electrical conductor 11 or 12 and makes direct and close contact with them.

[0072] The electrical insulator 20 may have substantially plate-like portions 19.

[0073] Preferably, the electrical insulator 20 is formed of a ceramic material and manufactured as a single component. The insulating material body 20 may be formed of multiple layers, which may be made of different materials, for example, and preferably all of them are electrically insulating.

[0074] The electrical insulator 20 may be formed from a polymer material.

[0075] A rotary joint DJ may be provided between the support link 10 and at least one of the two tips 21 and 22, thereby constraining at least one of the tips and the respective electrical conductor support portions of the support link 10 to rotate relative to a common axis (yaw axis YY). Preferably, both of the two tips 21 and 22 are constrained to rotate relative to the support link 10 around the same common axis (yaw axis or yaw YY). According to a preferred embodiment, the rotary joint between the support link 10 and each of the two tips 21 and 22 comprises at least one pin joint, in which the joint pin extends along the common axis of rotation (e.g., yaw axis or yaw YY).

[0076] According to one embodiment, for example, as shown in Figure 19, the distal rotational joint DJ may have rotation axes Y1 and Y2 of tips that are parallel to each other but not aligned.

[0077] The articulated pin is preferably an articulated pin assembly 30 comprising at least two half-pins 31, 32 that are separated and spaced apart from one another. The two half-pins 31, 32 are preferably aligned with each other, i.e., coaxially arranged. The articulated pin 30, and each of its half-pins 31, 32, may be manufactured from an electrically conductive material such as surgical steel. For example, the two half-pins 31, 32 of the articulated pin assembly 30 and the electrical conductors 11, 12 of the support link 10 are manufactured from the same conductive material.

[0078] Air may be interposed between the two half-pins 31 and 32, i.e., a gap 33 may be provided. A sphere 33 made of an electrically insulating material may be interposed between the two half-pins 31 and 32, for example, a glass sphere in the range of 0.2 mm to 0.5 mm in diameter. An element 33 made of an electrically insulating material, such as a drop of paint, may be interposed between the two half-pins 31 and 32. For example, at least one of the half-pins 31 and 32 may have a painted end, thereby forming an electrically insulating element 33.

[0079] According to one embodiment, for example as shown in Figure 20, the conductive half-pins 31, 32 and the element 33 formed of an insulating material may be formed by selective coating of a single articulated pin. For example, the articulated pin may be made of steel and comprise a first electrical insulating coating and a second electrical conductive coating formed on the insulating coating, with the longitudinal central portion of the pin lacking the conductive coating. Thus, the coating pattern defines the insulating element 33 and the conductive elements 31, 32 (half-pins).

[0080] The intervening insulating material elements are preferably in contact with the insulating material elements 20 of the support link 10, thereby forming electrical insulating continuity with the insulating material body 20, particularly its plate-like portion 19. The insulating material elements 33 between the two half-pins 31, 32 of the articulated pin assembly 30 may be formed by a layer of insulator 20. For example, the holes in the electrical insulator 20 are blind holes for receiving the articulated half-pins 31, 32.

[0081] According to one embodiment, two opposing articulated half-pins (not shown) each extend from an electrical insulator 20 and form a rotational pin joint with the respective tips 21 and 22. The two opposing half-pins may be made of an electrical insulating material (e.g., formed from the insulator 20 and a single component) or of an electrical conductive material (e.g., fixed to the insulator 20).

[0082] In a preferred embodiment, the electrical insulator 20 of the support link 10 extends between the tips 21 and 22. In other words, a portion of the electrical insulator 20 extends between the mounting bases 27 and 28 of the tips 21 and 22 in the axial direction of the yaw axis YY. In one embodiment, the portion of the electrical insulator 20 extending between the mounting bases 27 and 28 of the tips 21 and 22 includes through holes (e.g., coaxial) that align with the through holes of the mounting bases 27 and 28 of the tips 21 and 22, and the through holes of the support portions 13 and 14 of the respective electrical conductors 11 and 12 (e.g., each having two prongs). The articulated pin assembly 30 is inserted into the aligned through holes and defines the distal rotational joint DJ of the support link 10.

[0083] On the proximal side, the support link 10 can be rigidly fixed to the positioning rod of the device 1 or the distal portion 34 of the shaft 3.

[0084] Alternatively, at least one proximal joint PJ may be provided to articulate the support link 10 with the distal portion 34 of the positioning rod or shaft 3.

[0085] In a preferred embodiment, the support link 10 defines two orthogonal joints, for example, a pitch joint PP and a yaw joint YY, including a proximal joint PJ and a distal joint DJ. Preferably, each rotational joint PJ, DJ is a rotational pin joint. In one embodiment, each rotational joint PJ, DJ is defined by two opposing electrical conductor support portions 13, 14, 15, 16 and electrical insulation portions 19, 29 between them.

[0086] According to one embodiment, the proximal joint PJ forms the pitch joint of the articulated end 2. To define such a proximal pitch joint, the support link 10 may comprise two electrical conductor proximal support portions 15 and 16 belonging to electrical conductors 11 and 12, respectively, and an insulating support portion 29 belonging to an electrical insulator 20, positioned between them. Preferably, the proximal support portions 15 and 16 and the insulating support portion 29 of each electrical conductor 11 and 12 all have through holes, all of which are aligned (e.g. coaxially) to receive the articulation pin assembly 30. Preferably, the proximal support portions 15 and 16 and the insulating support portion 29 of each electrical conductor 11 and 12 all have substantially identical curved and convex profiles (in a plane perpendicular to the pitch rotation axis PP).

[0087] According to one embodiment, the proximal joint PJ for articulating the support link 10 with the positioning rod or shaft 3 is formed by the distal portion 34 of the positioning rod or shaft itself. Preferably, the distal portion 34 of the positioning rod or shaft 3 includes prongs or lugs that form a support for positioning the pitch axis PP. The distal portion 34 of the rod preferably includes a through hole, which is coaxially positioned with the through holes of the proximal support portions 15, 16, 29 of the respective electrical conductors 11, 12 and insulators 20 of the support link 10. The articulation pin assembly 30 is preferably inserted into the coaxial through hole, thereby defining the pitch rotation axis PP.

[0088] As described above, each of the two tips 21 or 22 of the bipolar electrosurgical instrument 1 is polarized with a different charge from the other tip, for example, with opposite charges, i.e., positive-negative, by providing two separate conductive paths that extend separately through the articulated end 2. In one embodiment, the two separate conductive paths also extend to at least a portion of the positioning rod or shaft 3, and in particular to at least the distal portion 34 of the rod.

[0089] For this purpose, the distal portion 34 of the rod may have a single prong, and the other opposing prong may be formed by a proximal link 35 fixed to the positioning rod 3.

[0090] Of course, the electrical insulating element 36 is preferably interposed between the proximal link 35 and the distal portion 34 of the rod. According to one embodiment, the proximal link 35 has a single support prong for the pitch axis PP having a through hole for receiving the articulation pin assembly 30, so that the single prong of the proximal link 35 and the single prong of the distal portion 34 of the positioning rod 3 jointly support the pitch articulation pin.

[0091] The distal portion of the positioning rod 3 may comprise a hollow body, and the proximal link 35 is mounted within an internal cavity 39 of the distal portion 34 of the rod (for example, secured by one or more fixing pins 38 or key-coupled). The positioning rod may further comprise two coaxial conductive elements 41, 42 (e.g., a blanket 41 and a core 42) polarized with opposite charges, between which is an electrically insulating element 36 (e.g., a ring 36 or sleeve 36) extending in a generally circular shape to form two separate conductive paths. The annular insulating element 36 may be formed by a centering bush. The internal cavity 39 receiving the proximal link 35 can obtain electrical conductivity through the curved sidewalls 26 of the support link 35.

[0092] For example, the core 42 alone may perform a structural function, i.e., be fixed to the proximal back end of the device, while the bracket 41 of the rod 3 may have an electrical function, or vice versa.

[0093] According to one embodiment, the proximal link 35 is mounted coaxially with the distal portion 34 of the positioning rod 3, so that a single prong of the distal portion 34 is located at a higher radial height than a single prong of the coaxial proximal link 35. In other words, in this embodiment, the prongs defining the support of the pitch proximal joint PJ are asymmetrical, i.e., not equidistant from the longitudinal extension axis RR of the positioning rod or shaft 3. Thus, each electrical conductor 11 or 12 of the support link 10 can have a seat 37 for receiving a single prong of the support link 35, while the opposite prong, belonging to the distal portion 34 of the positioning rod 3 and located at the outermost radial level, is not received by any seat.

[0094] The positioning rod or shaft 3 of the bipolar electrosurgical instrument 1 can form two separate conductive paths for tips 21 and 22 having different polarities. According to one embodiment, the positioning shaft or rod 3 comprises an outer portion or blanket 41 (formed from an electrically conductive material such as surgical steel) and an inner portion 42 or core 42 (formed from an electrically conductive material), the outer portion or blanket 41 and the core 42 being polarized with different charges, the outer portion or blanket 41 being electrically connected to one tip and the inner portion 42 or core being electrically connected to the other tip. For example, as shown in Figures 6A-B, the outer portion or blanket 41 can form a single prong or ear of the distal portion 34 of the shaft and be electrically connected to it, while the inner portion 42 or core can be electrically connected to a single prong or ear of the proximal link 35.

[0095] The outer portion 41 and inner portion 42 of the positioning rod or shaft 3 may preferably both be hollow inside and may be arranged coaxially with respect to the longitudinal extension axis RR of the positioning rod or shaft 3. A gap 52 may be provided and interposed between the outer portion 41 and the inner portion 42 and / or between the outer portion 41 and the inner portion 42 and / or between the outer portion 41 and the inner portion 42 and the element 36 made of an electrically insulating material such as an insulating ring or sleeve. For example, a plurality of rings made of an insulating material may be provided, which are arranged along the longitudinal extension direction of the positioning rod or shaft 3 and interposed between the blanket 41 and the inner portion 42, leaving a free space gap 52 between the continuous rings that are spaced apart in the longitudinal direction. The insulating ring or sleeve may be manufactured by molding. According to one embodiment, a hole or opening 43 for pouring a casting material, such as an adhesive, is provided in the blanket 41 and the adhesive is adapted to simultaneously form electrical insulation and mechanical sealing between the blanket 41 and the inner portion 42 of the positioning rod or shaft.

[0096] The ring 36, formed of an electrically insulating material, may also be formed by one or more centering bushings made of a polymer material (e.g., PEEK or polyetheretherketone), thereby simplifying the relative positioning of the blanket 41 with respect to the core 42 of an electrically conductive positioning rod or shaft having two separate conductive paths for the bipolar electrosurgical instrument 1.

[0097] For example, a hole or opening 43 can be provided in the blanket 41 at a position corresponding to the opening in the core 42 in order to insert a fixing pin 38.

[0098] The positioning rod or shaft 3 is preferably covered with a layer of electrical insulating material (e.g., a sleeve 40), which preferably also has thermal insulating properties. In other words, if a blanket 41 made of an electrical conductive material is provided, it may be covered with a coating made of an electrical insulating material such as silicone.

[0099] According to one embodiment, a protective cap 44 is provided to at least partially protect the articulated end 2 of the instrument 1, with the free ends 25 of the two tips 21 and 22 being exposed distally to the outside of the protective cap 44. For example, the protective cap 44 has two distal openings 51 for receiving the two tips 21 and 22 individually. The protective cap 44 is preferably made of a silicone material and is preferably elastically deformable (stretchable) and maintains a tight seal with the articulated end 2 while accommodating its movement. The protective cap 44 can form a fluid seal with respect to the articulated end and / or the positioning rod or shaft 3 to prevent fluid, vapor and smoke from reaching the articulated end 2 in the operating state. The protective cap 44 may also include a single-piece sleeve 40 covering the positioning rod or shaft 3.

[0100] Preferably, an actuating tendon 45 is provided to open and close the tips 21, 22 of the articulated end 2 and to actuate them in the yaw (distal rotational joint DJ). The actuating tendon 45 extends from the transmission interface portion 4 along the positioning rod or shaft 3, preferably through its interior, i.e., through the interior portion 42 or core, to reach an end seat 46 provided within the body of the articulated end 2, particularly the tip links 21, 22 to be actuated.

[0101] For example, as shown in Figures 3A-D, in order to move the first tip 21 relative to the support link 10 around the yaw axis YY, and in particular to move the first tip 21 relative to the support portion 13 of the first electrical conductor 11 of the support link 10, the actuari tendon 45 is terminated distally at a terminal seat 46 provided on the body of the mounting base 27 of the first tip 21. The mounting base 27 or 28 generally forms a pulley portion, i.e., has a cylindrical surface around which the distal segment of the actuari tendon is wrapped near the terminal seat 46. The distal end of the actuari tendon 45 may have a knot, boss, or other enlarged portion to achieve a rotational traction action against the undercut wall of the terminal seat 46.

[0102] An actuating tendon 45, terminated at the end seat 46 of the first tip 21, extends through the articulated end 2 and is wound in particular around the pulley portion 48 of the support portion 15 of the first electrical conductor 11 of the support link 10. When the actuating tendon 45 pulls the first tip 21, it slides on the pulley portion 48 of the support portion 15 of the first electrical conductor 11 of the support link 10. The pulley portion 48 has a sliding surface that is convex and woven in shape to facilitate the sliding of the tendon 45, and the sliding surface is entirely formed by generatrix parallel to the pitch rotation axis PP. Another actuating tendon (not shown) for actinguating the second tip 22 to the support portion 14 of the second electrical conductor 12 of the support link 10 may follow a reverse winding path, i.e., it may be wound in the opposite winding direction on the convex woven in shape surface of the pulley portion 48 of the proximal support portion 16. Furthermore, the actuarial tendon 45 is also wrapped around the pulley portion 49 of the proximal link 35 while sliding, and this pulley portion 49 also has a sliding surface that is convex and has a wire-woven surface in order to facilitate the sliding of the tendon, and all sliding surfaces are formed by generatrix parallel to the pitch rotation axis PP. The wire-woven surface and the pulley portions 48 and 49 do not have guide channels or concave grooves for receiving the actuarial tendon.

[0103] The electrical conductors 11 and 12 of the support link 10 may have other wire-woven sliding surfaces 50 in addition to the pulley portions 48 of the proximal support portions 15 and 16. According to one embodiment, each of the electrical conductors 11 and 12 has a wire-woven sliding surface 50 formed by a generatrix parallel to the yaw rotation axis YY. This allows,

[0104] The support link 10 is also preferably actuated by at least one of its actuating tendons (two antagonistic tendons) and may have a terminal seat 47 to receive the action of the actuating tendon. The terminal seat 47 of the support link 10 may be formed by a through hole (for example, a hole penetrating in a direction parallel to the yaw rotation axis YY) provided in the electrical insulator 20. The electrical conductors 11 and 12 are positioned so that the terminal seat 47, i.e., the through hole in the electrical insulator 20, is accessible, in other words, unobstructed, in the direction of the yaw axis YY.

[0105] The actuarial tendon 45 is an electrically nonconductive actuarial tendon, preferably a braided polymer tendon. For example, the polymer tendon is formed by braiding fibers made of ultra-high molecular weight polyethylene (UHMWPE). For example, the polymer tendon is formed of Kevlar®. Therefore, the polymer actuarial tendon is unsuitable to function as an electrical conductor and avoids short circuits between the articulated end 2 portions polarized with opposite charges. For example, the actuarial tendon for the second tip 22 slides on the wire-woven surface of the pulley portion 49 of the proximal link 35 and on the pulley portion 48 of the second electrical conductor 12 of the support link 10, thereby avoiding energizing the second electrical conductor 12 (which is further energized with the distal portion 34 of the shaft) with the proximal link 35.

[0106] By combining a polymer-acting tendon with a linear and convex sliding surface, it becomes possible to achieve extreme miniaturization of the articulated end.

[0107] As described above, the support link 10 preferably has no movable parts, i.e., no internal degrees of freedom. The electrical insulator 20 may be fixed to the two electrical conductors 11 and 12, or interposed between them, and may be fixed in various ways.

[0108] In a preferred embodiment, the electrical insulator 20 is interposed between and in contact with the electrical conductors 11 and 12, and, if provided, in contact with the proximal rotational joint PJ (pitch axis PP) with the proximal link 35, and with the distal rotational joint DJ (yaw axis YY) with the tips 21 and 22. The electrical insulator 20 includes flat positioning surfaces 61, 62, 63, and 64 for contacting the flat positioning opposing surfaces provided on the electrical conductors 11 and 12. Preferably, the electrical insulator 20 includes a plate-like portion 19, the plate-like portion 19 includes two opposing flat positioning surfaces 61 and 62, which are preferably parallel to each other, simultaneously perpendicular to the yaw axis YY, and facing in opposite directions. The electrical insulator 20 further includes a proximal support portion 29, the proximal support portion 29 includes its two flat positioning surfaces 63 and 64, which are preferably parallel to each other and simultaneously perpendicular to the pitch axis PP. The plate-like portion 19 may be provided with blind holes or through holes for yaw, and the proximal support portion 29 may be provided with blind holes or through holes for pitch. The plate-like portion 19 of the electrical insulator 20 has a proximal edge 53 on the opposite side in addition to the distal edge 54. The proximal support portion 29 may extend proximally from the proximal edge 53 of the plate-like portion 19 of the electrical insulator 20. The proximal edge 53 and distal edge 54 of the plate-like portion 19 of the electrical insulator 20 may be parallel to each other and have substantially the same extending length in the lateral direction (direction parallel to the pitch axis), thereby forming a plate-like portion 19 that generally has a quadrangular (e.g., rectangular or square) or polygonal planar shape, forming an electrical insulation barrier between the two electrical conductors 11 and 12 of the support link 10.

[0109] Preferably, the electrical insulator 20 further comprises at least one recess 55, 56, which is preferably located on the distal edge 54 of the electrical insulator 20 and receives a distal armlet or hook 57, 58 of the first electrical conductor 11 or the second electrical conductor 12. Preferably, the recesses 55, 56 are located on or next to each flat positioning surface 61, 62 of the plate-like portion 19 of the electrical insulator 20 and also form recesses with respect to the flat positioning surfaces 61, 62. Thus, the distal armlet 57 of the first conductor 11 defines a seat for receiving the recess 55 of the insulator 20, and the distal arm 58 of the second conductor 12 defines a seat for receiving the recess 56 of the insulator 20.

[0110] The distal armlets 57 and 58 of the electrical conductors 11 and 12 enable assembly to the insulator 20 by sliding (Figures 7B and 8C), and at the same time form a constraint on the distal edge 54 of the insulator 20 in a direction parallel to the yaw axis YY. In other words, by providing opposing distal armlets 57 and 58, it is possible to minimize the clearance in the direction of the yaw axis at the level of the distal edge 54 of the insulator, which contributes to accurately maintaining the action of the electrical conductor tip even with a weak operating force.

[0111] The axial recesses 55 and 56 (in the direction of the yaw axis YY) are positioned to receive the distal arms 57 and 58, respectively, and are configured to maintain electrical insulation. That is, the distal arm 57 of the first conductor 11 prevents the generation of an electric arc with the portion of the conductor 12 polarized with the opposite charge.

[0112] By providing distal armlets 57 and 58, the distal arm provides a constraint function in the direction of the yaw rotation axis YY of the distal rotation joint DJ, making it possible to use a joint pin assembly 30 with two separate and isolated half-pins in the distal rotation joint DJ.

[0113] The electrical conductors 11 and 12 may be provided with a proximal seat 59 for receiving the proximal edge 53 of the plate-like portion 19 of the electrical insulator 20 located on the opposite side from the distal armlets 57 and 58. The proximal seat 59 cooperate to minimize clearance in the direction of the yaw axis YY.

[0114] According to one embodiment, the respective support portions 13 and 14 of the electrical conductors 11 and 12 are provided with flat positioning opposing surfaces 65 and 66, respectively, intended to abut against the respective flat positioning surfaces 61 and 62 of the plate-shaped portion 19 of the electrical insulator 19. The respective armlets 57 or 58 preferably form a bent segment facing the flat positioning opposing surface 65 or 66. Preferably, the support portions 13 and 14 of each electrical conductor 11 and 12 are provided with two prongs, between which are defined mounting seats 67 and 68 for receiving the mounting bases 27 and 28 of the respective tip links 21 and 22, and one of the two prongs is provided with a positioning opposing surface 65 or 66 facing away from its mounting seats 67 and 68.

[0115] According to one embodiment, the proximal support portions 15 and 16 of the electrical conductors 11 and 12 are each provided with flat positioning opposing surfaces 69 and 70 for contacting the respective flat positioning surfaces 63 and 64 of the proximal support portion 29 of the electrical insulator 20.

[0116] According to one embodiment, the two electrical conductors 11 and 12 are manufactured identically to each other, as shown in Figures 9A-C, for example. The two electrical conductors 11 and 12 may be manufactured by wire electrical discharge machining (WEDM), starting from a metal workpiece such as surgical steel, and using the same cutting profile in two mutually orthogonal cutting planes. This simplifies mass production and allows the conductors 11 and 12 to be easily assembled with the insulator 20.

[0117] The electrical insulator 20 may be manufactured by sintering ceramic powder. The electrical insulator 20 may be milled, for example, to form recesses 55, 56.

[0118] The electrical insulator 20 may be manufactured by molding (micro-molding) a polymer material.

[0119] The proximal link 35, which has a single prong, may be manufactured by forming and milling a metal material such as surgical steel.

[0120] Therefore, the proximal rotary joint PJ defining the pitch axis PP may comprise the proximal support portions 15 and 16 of the conductors 11 and 12, the proximal support portion 29 of the insulator 20, and the individual prongs of the proximal link 35 and the distal portions 34 of the rods, all of which are stacked in a pack and in direct and close contact with one another. The articulation pins of the proximal rotary joint PJ may be an articulation pin assembly 30 comprising two half-pins 31 and 32 made of electrically conductive material that are not electrically conductive to each other. This makes it possible to form an electrical continuity path including the proximal link 35, the respective proximal support portions 15 of the first conductor 11, and the respective half-pins 31, and an electrical continuity path including the distal portion 34 of the positioning rod 3, the respective proximal support portions 16 of the second conductor 12, and the respective half-pins 32. The two conductive paths are electrically isolated by the provision of the electrical insulator 20 and the electrical insulating portion 33 of the articulation pin assembly 30. The electrically insulating portion 33 of the joint pin assembly 30 may comprise air and / or an insulator, such as a glass body, such as a glass sphere.

[0121] Therefore, the distal rotational joint DJ defining the yaw axis YY may comprise support portions 13 and 14 of conductors 11 and 12, a plate-shaped portion 19 of an insulator 20, and mounting bases 27 and 28 of a first tip 21 and a second tip 22, all of which are stacked in a pack-like manner and in direct and close contact with each other. The joint pins of the distal rotational joint DJ may be an articulated pin assembly 30 comprising two half-pins 31 and 32 made of electrically conductive material that are not electrically conductive to each other. This makes it possible to form an electrical continuity path including the support portion 13 of the first electrical conductor, the mounting base 27 of the first tip 21, and the first half-pin 31, and an electrical continuity path including the support portion 14 of the second electrical conductor, the mounting base 28 of the second tip 22, and the second half-pin 32. The two conductive paths are electrically insulated by providing the electrical insulator 20 and the electrically insulating portion 33 of the articulated pin assembly 30. On the proximal side, the two electrical conduction paths may extend such that the first path includes the proximal support portion 15 of the first conductor, the first half-pin 31, and the proximal link 35, and the second path includes the proximal support portion 16 of the second conductor, the second half-pin 32, and the distal portion 34 of the positioning rod 3.

[0122] In the assembled support link 10, the seat portions 59 of each conductor 11, 12 form proximal contact portions with the proximal edge 53 of the plate portion 19 of the electrical insulator 20, and the armlets 57, 58 form distal contact portions with the distal edge 54 of the plate portion 19 of the electrical insulator 20. In a direction parallel to the pitch axis PP, the flat positioning surfaces 63, 64 of the proximal support portion 29 of the electrical insulator 20 abut against the flat positioning opposing surfaces 69, 70 of the first and second conductors, respectively. A single prong of the proximal link 35 can be received in close contact within its seat portion 37 of the proximal support portion 15 or 16 of the first or second conductor 11 or 12. A single prong of the distal portion 34 of the positioning rod 3, which has the opposite charge to the proximal link 35, can be in close contact with the proximal support portion 16 or 15 of the second or first conductor 12 or 11.

[0123] In a preferred embodiment, the electrical insulation barrier is formed along the articulated end 2 of the bipolar electrosurgical instrument 1 and comprises an electrical insulator 20 and an electrical insulation portion 33 of the articulation pin assembly 30 of the distal rotator joint DJ. Preferably, the electrical insulation barrier also includes an electrical insulation portion 33 of the articulation pin assembly 30 of the proximal rotator joint PJ and an insulating layer or ring 36 attached to the distal portion 34 of the positioning rod, as well as an insulating gap provided between the blanket 41 and the inner portion 42 of the positioning rod 3.

[0124] For example, the assembly of the electrosurgical instrument 1 may include bonding the outer portion 41 and inner portion 42 of the positioning rod 3 by molding epoxy resin through an opening 43, thereby distributing the epoxy resin within the gap 52 between the outer portion 41 and inner portion 42 of the rod. The proximal link 35 is then attached to the distal portion 34 of the rod, where a coaxial hole for the pitch rotation axis PP is drilled. At this point, the proximal link 35 can be removed from the positioning rod and assembled with the support links 10 and tips 21, 22.

[0125] As described above, according to one embodiment, the electrical insulator 20 is molded separately from the electrical conductors 11 and 12 of the support link 10, and then the electrical insulator 20 and the electrical conductors 11 and 12 are assembled together. For example, the insulator 20 may be manufactured by molding and / or milling, the conductors 11 and 12 may be manufactured by wire electrical discharge machining on two orthogonal cutting planes, and assembly may be performed by bonding and the use of joint pins.

[0126] According to one embodiment, the support link 10 may be manufactured entirely by wire electrical discharge machining (WEDM) on two mutually orthogonal cutting planes, in which case the workpiece may already include a composite multilayer structure 90 comprising an electrical insulator 20 interposed between two electrical conductors 11, 12. For example, as shown in Figure 15A, the workpiece 90, i.e., the workpiece cut by wire electrical discharge machining (WEDM), is a composite workpiece 90 comprising two electrically conductive workpieces 91, 92 (e.g., metal such as steel), which are appropriately molded to form a hollow seat between them, and a molded electrical insulating material 93, such as epoxy resin 93, is placed within the hollow seat, which acts as an adhesive to hold the electrically conductive workpieces 91 and 92 in a bonded state during the wire electrical discharge machining cutting process, and also acts as an electrical insulating element. Fixing means can be provided to fix the conductive workpieces 91, 92 together with the epoxy resin 93 in a pack-like manner.

[0127] The composite workpiece 90 having a multilayer structure is preferably cut by the cutting wire 98 of a wire electrical discharge machine 99 in two mutually orthogonal cutting planes to form two orthogonal shaping cuts CUT1 and CUT2 in the composite workpiece, for example, as shown in Figures 15B and 15C. The shaping cuts CUT1 and CUT2 of wire electrical discharge machining are preferably through cuts into the composite workpiece 90. The composite workpiece 90 may include a cylindrical mounting portion 96, which is fitted to be inserted into the respective holes of a wire electrical discharge machining jig. The cylindrical mounting portion 96 can be used to rotate the workpiece 90 individually between the shaping cuts CUT1 and CUT2, i.e., a motor can be provided to rotate the cylindrical mounting portion 96 of the composite workpiece 90.

[0128] An insulating layer made of epoxy resin 93 or other insulating material, i.e., a cavity between two conductive workpieces 91, 92, can have a specific shape that allows for the formation of a multilayer structure in two parts defining a rotary pin joint PJ, DJ having axes perpendicular to each other. For this purpose, the cavity, i.e., the epoxy resin layer 93, can comprise a substantially flat portion 94, i.e., a portion parallel or perpendicular to the cutting wire of the electrical discharge machine 99, and an inclined portion 95, i.e., an oblique portion that is neither parallel nor perpendicular to the cutting wire 98. For example, as shown in Figure 14D, the inclined portion 95 of the insulating material allows for the placement of an inclined, i.e., oblique insulating material layer 20 with respect to the pitch axis PP in the proximal rotary joint PJ of the support link 10, thereby obtaining two locally distinct and separated conductive paths in the direction of the pitch axis PP (i.e., thereby forming the proximal support portions 15, 16 of the conductors 11, 12). At the same time, by providing the inclined portion 95 and the flat portion 94 as a single component, it is possible to form locally separate conductive paths in the direction of the yaw axis YY (i.e., thereby forming support portions 13 and 14 for each of the tips 21 and 22).

[0129] By providing the inclined portion 95, the electrical insulator 20 between the two electrical conductors 11 and 12 of the support link 10 becomes stronger, or in any case, stronger than when an orthogonal portion of epoxy resin is provided instead of the inclined portion 95.

[0130] The angle between the flat portion 94 and the inclined portion 95 is preferably in the range of 30° to 60°, and more preferably substantially 45°.

[0131] By providing the above-described features in combination with or without each other in specific embodiments, the aforementioned needs can be met, and thus the aforementioned advantages, in particular the following, can be achieved:

[0132] - A miniaturized bipolar gripping device is provided;

[0133] - Bipolar electrical connection, i.e., polarization into two poles, is formed through the metal structure of the articulated end;

[0134] - The need to provide external electrical cables extending through the movable joint (articulated end) of the chip is avoided;

[0135] - The articulated end preferably comprises an articulated cuff having two orthogonal rotational pin joints;

[0136] - By avoiding external cables, stress and mechanical damage caused by tensile forces applied by cables during the operation of the articulated end are avoided, thereby enabling the formation of an articulated end that is very compact and suitable for extreme miniaturization, and that requires low tensile force to operate the movable part (link) of the articulated end;

[0137] - A robust articulated end is formed that is resistant to temperature and mechanical loads during active robotic surgery;

[0138] - The need for a dedicated control algorithm to compensate for imbalances in the transmission of operating forces at the articulated end, which may be induced by the installation of cables, is avoided.

[0139] - The use of actuating tendons allows for precise control of the degrees of freedom at the articular end;

[0140] - The dimensions (thickness) of the electrical insulator are selected to avoid the formation of an electric arc between the electrical conductors 11 and 12 of the support link;

[0141] - An articulated pin formed by two half-pins can be dimensioned to avoid the formation of an electric arc between the two half-pins and between the half-pins and electrically opposite polarity conductors of the support link;

[0142] - The longitudinal shape of the tips may be selected to minimize the risk of electric arcs forming between the tips in the portions located outside their respective working parts;

[0143] - Where necessary, the need to install electrical cables within the cavity of the positioning rod or shaft is avoided, because bipolar electrical connection, i.e., polarization into two poles, is achieved through the coaxial metal structure of the positioning rod or shaft itself;

[0144] - The internal cavity of the positioning rod shaft may be occupied by the working tendons of the rotary joint at the articulated end;

[0145] - The positioning rod or shaft may be formed by two coaxial rods or shafts polarized with opposite charges.

[0146] - The internal rod or shaft may be fixed to the proximal link, for example, by key coupling within the internal cavity of the rod or shaft, thereby forming an electrical conduction through its sides;

[0147] -It is possible to form a support link having a multilayer structure with an insulating layer between two electrically conductive layers;

[0148] - Electrical conduction is achieved by a large contact surface with electrically conductive articulated half-pins;

[0149] - The diameter of the coaxial positioning rod or shaft can easily be less than 5 millimeters;

[0150] - Bipolar electrosurgical instruments are adapted to operate in both cutting and coagulation modes, as well as combinations thereof, enabling vascular sealing applications for vessels with a diameter of less than 2 millimeters.

[0151] - Bipolar electrosurgical instruments are particularly well-suited for extremely miniaturization of articulated ends while ensuring electrical isolation of the outward and return pathways and providing sufficient robustness under operating conditions.

[0152] It will be fully understood that the combination of features disclosed in the attached claims forms an integral part of this disclosure.

[0153] To meet specific, situational needs, those skilled in the art can make various modifications and adaptations to the embodiments described above, and can replace elements with other functionally equivalent elements without departing from the scope of the appended claims. [Explanation of Symbols]

[0154] 1. Bipolar electrosurgical instruments 2 Articulated ends 3. Positioning rod or shaft 4. Transmission interface portion, or backend. 5. Robot Manipulator 6 connectors 7. Operating table or bed 8 patients 9 Master control station 10. Articulated end support links 11. First electrical conductor or first conductor of the support link 12. Second electrical conductor or second conductor of the support link 13 First support portion of the first conductor 14 Second support portion of the second conductor 15 First proximal support portion of the first conductor of the support link 16 Second proximal support portion of the second conductor of the support link 17. Electrosurgical generator 18 Footswitches 19 Plate-shaped portion of the insulator 20 Third electrical insulator or insulator of the support link 21. First tip, or first tip link, or first jaw of the articulated end. 22. Second tip, or second tip link, or second jaw of the articulated end. 23 Operating part of the first chip 24 Operating part of the second chip 25 Free end 26 Proximal link surface 27 First mounting base of the first chip 28 Second mounting base of the second chip 29 Proximal support portion of the insulator, or prong of the insulator 30-joint pin assembly 31. First pin section 32. Second pin section 33 Electrical insulation elements of pin assemblies 34 Distal portion of the positioning rod or shaft 35. Proximal link of articulated end 36 Electrical insulation element between the proximal link and the distal portion of the rod 37. Seat for proximal link prong 38 Fixing pins 39 Internal cavity of positioning rod or shaft 40 Insulating Sleeves 41. The bracket or outer part of the rod 42 Inside part of the rod 43 Rod opening 44 protective caps 45 Actuating tendon 46 End seat portion of tip link mounting base 47 End seat of support link 48 Pulley portion of the support link having a convex wire-woven sliding surface 49 Pulley portion of the proximal link having a convex wire-woven sliding surface 50 Other convex wire woven sliding surfaces of the support link 51 Distal opening of protective cap 52 Gap 53 Proximal edge of the insulating plate-like portion 54 Distal edge of the insulating plate-like portion 55 Recess of the insulator 56 Recess on the opposite side of the insulator 57 Distal armlet of the first conductor 58 Distal armlet of the second conductor 59 Proximal seat of a conductor 61 Positioning surface of plate-shaped portion 62 Positioning surface on the opposite side of the plate-shaped portion 63 Positioning surface of the proximal support portion 64 Positioning surface opposite the proximal support portion 65 Positioning opposing surface of the first conductor 66 Positioning opposing surface of the second conductor 67 Mounting seat portion of the first conductor 68 Mounting seat portion of the second conductor 69 Positioning opposing surface of the first conductor 70 Positioning opposing surface of the first conductor 90 Composite Workpieces 91 First electrically conductive member 92 Second electrically conductive member 93 Insulating material layer, e.g., epoxy resin 94 First flat portion of insulating material 95 Second inclined portion of insulating material 96 Mounting section of composite workpiece 98 Cutting wire for wire electrical discharge machining 99 Wire EDM Machine 100 Robotic systems for medical or surgical remote operation PP pitch axis YY yaw axis RR Positioning rod or shaft longitudinal extension axis PJ Proximal rotational joint of articulated end Distal rotational joint of the articular end of the DJ articulated joint CUT1 Forming and Cutting Profile CUT2 Forming Cutting Profile Distal direction

Claims

1. A bipolar electrosurgical instrument (1) having an articulated end (2), Support link (10), A first chip (21) is movable relative to the support link (10) and has an electrically conductive body having its own operating part, The system includes a second chip (22) which is movable relative to the support link (10) and has an electrically conductive body having its own operating part, Here, The operating parts of the first chip (21) and the operating parts of the second chip (22) are movable toward and away from each other. The support link (10) has a multilayer structure formed by a first electrical conductor (11), a second electrical conductor (12), and at least one electrical insulator (20) between them. The first electrical conductor (11) of the support link having the first support portion (13) and the first tip (21) is attached to the first support portion (13) while energized, thereby realizing a first conductive path toward the operating portion of the first tip. The second electrical conductor (12) of the support link having the second support portion (14) and the second tip (22) is attached to the second support portion (14) while energized, thereby realizing a second conductive path from the operating portion of the second tip. A bipolar electrosurgical instrument (1) wherein the first conductive path and the second conductive path are separated from each other within the body of the support link by at least one electrical insulator (20).

2. The first electrical conductor (11) and the second electrical conductor (12) of the support link (10) are each integrally fixed to the electrical insulator (20); and preferably, the support link (10) has no internal degrees of freedom; The apparatus according to claim 1, wherein the electrical conductors (11, 12) are both fixed to the electrical insulator (20) while remaining separated from each other over the entire volume of the support link (10).

3. The apparatus according to claim 1 or 2, wherein the electrical insulator (20) is interposed between the first electrical conductor (11) and the second electrical conductor (12) over their entire extended portions.

4. The first support portion (13) and the first tip (21) of the first electrical conductor (11) of the support link are constrained to rotate around the axis of rotation. The apparatus according to any one of claims 1 to 3, wherein the second support portion (14) and the second tip (22) of the second electrical conductor (12) of the support link are constrained to rotate about their own axes of rotation, which may be parallel to or aligned with the axis of rotation, thereby defining a distal rotational joint (DJ) of the articulated end (2) having the multilayer structure formed of the two electrical conductors and the electrical insulator between them.

5. The apparatus according to claim 4, wherein the first support portion (13) and the second support portion (14) each comprise at least one prong formed of an electrically conductive material, preferably a pair of prongs formed of an electrically conductive material.

6. The first electrical conductor (11) of the support link (10) includes a first proximal support portion (15), The second electrical conductor (12) of the support link is provided with a second proximal support portion (16), The device according to claim 4 or 5, wherein the first proximal support portion and the second proximal support portion cooperate with each other to define a proximal rotational joint (PJ) of the articulated end (3) having the multilayer structure formed of the two electrical conductors and the electrical insulator between them.

7. The device according to claim 6, wherein the proximal rotational joint (PJ) has a proximal rotational axis (P-P) perpendicular to the rotational axis, thereby forming the multilayer structure formed of the two electrical conductors and the electrical insulator between them in two mutually orthogonal directions.

8. The at least one of the rotary joints is a pin rotary joint comprising a joint pin assembly (30), A first electrical conductor (11) and a first electrically conductive half-pin (31) that is energized with the first tip (21), The device comprises a second electrical conductor (12) and a second electrically conductive half-pin (32) that is energized with the second tip (22), Between the first half-pin (31) and the second half-pin (32), there is a gap, air, and an electrically insulating element (33) such as a sphere made of glass. Preferably, the first half-pin (31) and the second half-pin (32) are separated and divided from each other, the device according to any one of claims 4 to 7.

9. The apparatus according to any one of claims 1 to 8, wherein each of the two rotational joints (PJ, DJ) is actuated by one or more actuating tendons, preferably the actuating tendons are made of a non-conductive material such as braided polymer fibers.

10. The apparatus according to any one of claims 1 to 9, further comprising a positioning shaft (3) having two electrically conductive rigid bodies arranged coaxially, such as two steel cylinders, thereby forming a portion of the two separate conductive paths, and preferably the support link (10) being articulated to the positioning shaft (3) at the proximal rotational joint (PJ).

11. The two electrical conductors (11, 12) are manufactured by wire electrical discharge machining using two shaping cuts that are orthogonal to each other and substantially identical to each other, thereby obtaining two electrical conductors that are substantially identical to each other. Preferably, the two electrical conductors (11, 12) are manufactured as separate parts and then assembled to the electrical insulator (20). Preferably, the electrical insulator is manufactured as a single component, for example, by molding; The apparatus according to any one of claims 1 to 10, wherein each electrical conductor (11, 12) is provided with a distal armlet (57, 58) for gripping the distal edge (54) of the electrical insulator (20).

12. The electrical insulator (20) comprises a plate-like portion (19) and a proximal support portion (29) extending between the tips (21, 22) of the articulated end; and / or, each of the electrical conductors (11, 12) comprises at least two sliding surfaces (48, 50) for the working tendons of the corresponding tips (21, 22), All of the aforementioned sliding surfaces (48, 50) are convex wire-woven surfaces having straight parallel generatrixes, and the parallel generatrix of one of the two sliding surfaces (48 or 50) is perpendicular to the parallel generatrix of the other sliding surface (50 or 48). Preferably, the parallel generatrix of one sliding surface (48) is parallel to the axis of rotation of the proximal rotational joint (PJ), and the parallel generatrix of the other sliding surface (50) is parallel to the axis of rotation of the distal rotational joint (DJ); and / or the electrical insulator (20) is formed of a ceramic material, for example by powder sintering; and / or the electrical insulator (20) is formed of a polymer material, for example by molding; and / or the electrical insulator comprises at least two sliding surfaces (48, 50) for the working tendon, all of which are convex wire-woven surfaces having straight parallel generatrixes, and the parallel generatrix of one sliding surface (48 or 50) is perpendicular to the parallel generatrix of the other sliding surface (50 or 48), according to any one of claims 1 to 11.

13. The support link (10) is manufactured by wire electrical discharge machining using two mutually orthogonal forming cuts (CUT1, CUT2); The electrical insulator is fixed to the electrical conductor within a frame of adhesive resin before any shaping cut is performed, thereby forming a composite multilayer workpiece (90); Preferably, the electrical insulator has an inclined unfolding portion, and the inclined unfolding portion is not parallel to either the axis of rotation of the proximal rotator joint (PJ) or the axis of rotation of the distal rotator joint (DJ); preferably, the inclined unfolding portion is located near or on the proximal rotator joint (PJ), the device according to any one of claims 1 to 12.

14. A robotic system (100) for medical or surgical remote control, comprising at least one bipolar electrosurgical instrument (1) according to any one of claims 1 to 13.

15. A method for manufacturing a support link (10) of an electrosurgical instrument by wire electrical discharge machining, A composite workpiece (90) having a first electrical conductor, a second electrical conductor, and a cavity between them, and a step of placing an electrically insulating epoxy resin in the cavity, A step of attaching the composite workpiece to a wire electrical discharge machine (99) equipped with a cutting wire (98), A manufacturing method comprising the step of performing a first forming through-cut in the composite workpiece using the cutting wire (98), thereby forming a through-seat portion for an articulated pin.

16. A step of rotating the composite workpiece relative to the cutting wire, The process further includes performing a second forming through-cut on the same composite workpiece, thereby forming a second through-seat for a second articulated pin; and / or the method according to claim 15, wherein the cavity has a substantially flat portion and a substantially inclined portion.

17. A bipolar electrosurgical instrument (1) having an articulated end (2), Support link (10), It comprises two chips (21, 22) having an electrically conductive body, The two chips are articulated to the support link (10) and are movable in directions away from each other and toward each other. Here, The support link (10) comprises two support portions (13, 14) to which the two chips are attached, The two chips are arranged adjacent to each other and form a rotary pin joint (DJ) comprising a pin assembly (30). The aforementioned pin assembly (30) is A first half-pin (31) restrains the first tip (21) to rotate relative to the first support portion (13) of the support link, A second half-pin (32) restrains the second tip (22) to rotate relative to the second support portion (14) of the support link, Equipped with, An electrical insulating barrier (33) is provided between the first half-pin (31) and the second half-pin (32); for example, the electrical insulating barrier (33) comprises at least one of a gap, air, a sphere made of glass, or a pattern of coating, in a bipolar electrosurgical instrument (1).

18. A positioning shaft (3) having a distal portion, The shaft comprises an articulated end (2) connected to the distal portion of the shaft, The articulated end (2) comprises two tips (21, 22) having an electrically conductive body, The two chips are articulated to the distal portion of the positioning shaft and are movable toward each other in directions away from each other and toward each other. Here, The two chips (21, 22) are intended to be polarized with different charges. The positioning shaft (3) is provided with two coaxially arranged electrical conductors, thereby forming two separate conductive paths. A bipolar electrosurgical instrument (1) in which each of the two separate conductive paths of the positioning shaft (3) is energized with the tips (21 or 22) of the two tips.

19. An electrical insulation assembly for separating two conductive paths of an articulated end (2) of a bipolar electrosurgical instrument (1), The aforementioned articulated end defines at least two rotational pin joints, Each rotary pin joint has a pin assembly (30) including two electrically conductive half-pins (31, 32), The aforementioned electrical insulation assembly is A single component comprising an electrical insulator (20) defining two mutually orthogonal pin joints (PJ, DJ) of the at least two rotational pin joints, An electrical insulation assembly comprising an electrical insulation element (33) interposed between the two half-pins.

20. A method for assembling a support link (10) for an electrosurgical instrument, The process of providing two electrical conductors (11, 12) each having a plane (65, 66), and an electrical insulator (20) having two opposing planes (61, 62), The steps include sliding the electrical insulator (20) against the first electrical conductor (11), thereby causing the plane (61) of the electrical insulator to slide on the plane of the first electrical conductor, An assembly method comprising the step of sliding the plane of the second electrical conductor onto the plane opposite to the electrical insulator.

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