Bipolar electrosurgical instrument for medical surgical teleoperation and method of manufacture

Abstract

A bipolar electrosurgical instrument (1) comprising an articulated end (2) comprising a support link (10) and two ends (21, 22) comprising an electrically conductive body, said ends being articulated to the support link (10) and being movable towards / away from each other; wherein: said support link (10) comprises a multilayer structure comprising two electrically conductive bodies (11, 12) and at least one electrically insulating body (20) therebetween, each electrically conductive body (11, 12) of the support link comprising a support portion (13, 14) thereof receiving a respective end (21, 22) in electrically conductive communication therewith, a first outward conductive path and a second separate conductive return path passing through the conductive body of the ends (21, 22) and the support link (10); the support link (10) defines two rotational joints (PJ, DJ) having mutually orthogonal axes (P-P, Y-Y), where each of the two rotational joints comprises a multilayer structure, where an electrically insulating body (20) is interposed between two electrically conductive bodies (11, 12).

Description

Technical Field

[0001] This invention relates to an electrosurgical instrument.

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

[0003] The present invention further relates to a robotic system for remote medical or surgical operations including the aforementioned instrument.

[0004] Furthermore, the present invention relates to a method for manufacturing the aforementioned device.

[0005] The present invention further relates to an electrically insulating assembly for electrosurgical instruments. Background Technology

[0006] Robotic surgical devices are generally known in the art and typically include a central robotic tower and one or more robotic arms extending from the central robotic tower. Each arm includes an electrically operated positioning system (or manipulator) for distally moving attached surgical instruments to perform surgical procedures on the patient. The patient typically lies on an operating table located in an operating room where sterility is ensured to avoid bacterial contamination due to the non-sterile parts of the robotic device.

[0007] Generally, known surgical instruments for remotely operated robotic surgery include a proximal transmission interface (or "rear end," according to the terminology commonly used in the art), which has an interface designed to be operated by a robotic manipulator. Extending from the proximal interface are elongated elements, such as rods or shafts with a hinged device (e.g., a robotic sling) at their distal end, which has an operating end (e.g., a needle holder, scissors, dilator, scalpel).

[0008] Among known surgical instruments with articulated cuffs, it typically comprises multiple links that are moved by multiple ribs (or actuation cables). One or more terminal links may have free ends forming the aforementioned terminal operating ends, and are adapted, for example, to operate directly on the patient's anatomy and / or manipulate needles and sutures for anastomosis or other surgical treatments.

[0009] Unlike known surgical instruments that include articulated cuffs, surgical instruments with "snake"-shaped articulation devices are also known, which consist of multiple stacked vertebrae that can be moved relative to each other by means of multiple actuating cables or tendons.

[0010] For example, US-10582975 and WO-2018-189721, filed in the name of the same applicant, disclose various embodiments of surgical instruments for robotic surgery and microsurgery, which are designed to undergo extreme miniaturization of articulated sleeves and thus extreme miniaturization of operating ends or end effectors, wherein the links forming the end effectors are made by wire erosion.

[0011] Surgical instruments suitable for delivering electrical energy to tissues, such as electrocautery instruments for robotic surgery, are 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 include one or more conductors for transmitting electricity from a robotic manipulator to the articulated end of an end effector of the instrument itself via a transmission interface portion of the surgical instrument.

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

[0014] With all the articulated parts of the end effector, as well as the idler or stationary pulleys, made of metal, and the moving actuation cable made of steel or tungsten, there is a risk of poor electrical insulation, and voltage may be transferred throughout the articulated end, or even rearward to the proximal transmission interface (“rear end”), through the actuation cable. For these reasons, the active articulated ends of such known electrosurgical instruments are typically large and unsuitable for miniaturization.

[0015] To electrically insulate such articulated ends of active electrosurgical instruments, insulating sleeves are typically fitted over the entire end effector, thereby forming an electrical insulating barrier relative to or in contact with the patient tissue near or in contact with the end effector itself.

[0016] Especially in known laparoscopic electrocautery applications, it is crucial to avoid transmitting power at the fulcrum (i.e., the insertion point of the surgical instrument in its dedicated port), which represents the center of rotation of the positioning rod or axis relative to the patient under operating conditions. For these reasons, the positioning axis itself is made of electrically insulating material or coated with an insulating layer (such as rubber) to prevent arcing with the abdominal wall.

[0017] Such articulated electrosurgical instruments, especially in endoscopic or minimally invasive applications, have an internally hollow positioning shaft made of non-conductive plastic or composite material to avoid unwanted lateral discharge, and only an electrically conductive cable traveling in a specific channel carries the potential to the application terminal (e.g., a "jaw") made of metal and connected thereto.

[0018] In fact, monopolar electrosurgical instruments typically provide a cable that extends from the transmission interface portion (“rear end”) to the articulated sleeve inside the positioning rod or shaft of the surgical instrument. The positioning shaft is typically made of an electrically insulating material, while the operating end of the electrosurgical instrument is an electrically active metal. In such known monopolar electrosurgical instruments, after passing through a portion of the patient’s body, the circuit is closed via a return electrode (typically a floor).

[0019] In other ways, in bipolar electrosurgical instruments, the two ends of the instrument are polarized with different charges to form two electrodes, one of which forms a return electrode. In this type of electrosurgical instrument, it is necessary to avoid short circuits between different parts of the actuator with different charges (e.g., between the two ends and between the corresponding electrical conductors).

[0020] It is also known to use an electrically insulating sleeve fitted onto a hinged sleeve to prevent unintentional power transfer from areas other than the terminals (unipolar and bipolar instruments).

[0021] Because of the various components to be assembled, such as conductive devices for polarizing the ends (“jaws”) with opposite charges, electrically insulating devices, return pulleys, and hinged actuation cables at the hinged ends, known solutions for bipolar electrosurgical instruments are not suitable for extreme miniaturization at the level of the hinged ends.

[0022] Terminating or attaching a conductive cable to the end link of a small surgical instrument is technically complex.

[0023] The stiffness and dimensions of the conductor cable connected to the jaws or hinged ends affect movement, closing / opening, and clamping performance, especially for small instruments.

[0024] Therefore, there is a need to develop a bipolar electrosurgical device suitable for extremely miniaturization. Summary of the Invention

[0025] The purpose of this invention is to eliminate the drawbacks complained about by reference to the prior art and to provide a solution to the aforementioned needs.

[0026] This and other objectives 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 insulating component 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 invention, a bipolar electrosurgical instrument includes a hinged end portion comprising a support link and a first end portion movable relative to the support link and having a conductive body and an operating portion thereof, and a second end portion movable relative to the support link and having a conductive body and an operating portion thereof.

[0029] The operating portion of the end can be a clamping and / or cutting surface and / or a free end, such as a sharp free end.

[0030] The operating portions of the first and second ends can move toward or away from each other. Therefore, the operating portions of the ends can move relative to each other when opening or closing.

[0031] The support link has a multi-layer structure formed by a first conductive body, a second conductive body, and at least one electrically insulating body therebetween.

[0032] The first conductive body of the support link includes a first support portion, and a first end is mounted to the first support portion in a manner that provides conductive communication therebetween, forming a first conductive path, such as an outward conductive path to the operating portion of the first end.

[0033] The second conductive body of the same support link includes a second support portion, and a second end is mounted to the second support portion in a conductive communication therebetween, forming a second conductive path, such as a return conductive path from the operating portion of the second end.

[0034] By setting up a first conduction path and a second conduction path, a circuit can be closed through the body of the bipolar surgical instrument, and in particular its hinged ends with two ends and a support link with a multi-layer structure, which includes an electrically insulating layer between two conductive layers.

[0035] The first outward conduction path and the second return conduction path are separate and are separated from each other by the at least one electrically insulating body within the body of the supporting link.

[0036] The support portion of the support link may each include at least one fork-shaped member made of conductive material, and preferably two fork-shaped members.

[0037] Preferably, the support link has no internal degrees of freedom.

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

[0039] The hinged end may include other degrees of freedom, and the support link itself may be hinged relative to the positioning axis or rod of the bipolar electrosurgical instrument while maintaining electrical insulation between its conductive bodies. According to one embodiment, a first conductive body of the support link includes a first proximal support portion, and a second conductive body of the support link includes a second proximal support portion, the first and second proximal support portions cooperating to define a proximal rotational joint at the hinged end, the proximal rotational joint having the multilayer structure formed by the two conductive bodies and an electrically insulating body therebetween.

[0040] The proximal rotational joint preferably has a proximal rotational axis that is orthogonal to the rotational axis that hinges the end to the support link, thereby seamlessly defining a multi-layered structure formed by two conductive bodies and an electrically insulating body therebetween in two orthogonal directions.

[0041] The support link can be manufactured by wire electrical discharge machining of a workpiece made of a multi-layered material.

[0042] The support link can be manufactured by assembling separate parts, such as the electrically insulating body being molded and the conductive body being made by electrical discharge wire cutting.

[0043] Manufacturing via wire electrical discharge machining allows for the formation of sliding surfaces for actuating ribs to actuate at least one of the ends of the hinged end. Thus, according to one embodiment, each conductive body includes at least two sliding surfaces for the actuating rib at the respective end; said sliding surfaces are convex ruled surfaces with parallel generatrices, wherein the parallel generatrices of one sliding surface are orthogonal to the sliding surface of the other of the two sliding surfaces. Preferably, the parallel generatrices of one sliding surface are parallel to the rotation axis of the proximal rotary joint, and the parallel generatrices of the other sliding surface are parallel to the rotation axis of the distal rotary joint of the hinged end of the bipolar electrosurgical instrument.

[0044] The electrically insulating body of the supporting link may include a plate-like portion extending between the end of the hinged end and the proximal support portion. According to one embodiment, the electrically insulating body, and particularly its proximal support portion, includes at least two sliding surfaces for actuating the rib, and said sliding surfaces are both convex ruled surfaces with parallel generatrices, wherein the parallel generatrices of one sliding surface are orthogonal to the sliding surface of the other sliding surface.

[0045] According to one embodiment, the two conductive bodies of the support link are produced by electrical discharge wire cutting using two mutually orthogonal forming cuts that are substantially identical to each other, thereby obtaining two conductive bodies that are substantially identical to each other; and preferably, the two conductive bodies are manufactured as separate pieces and then assembled into an electrically insulating body.

[0046] According to one aspect of the invention, a method for assembling a support link for an electrosurgical instrument can be provided, the method comprising the steps of: providing two conductive bodies, each having a flat surface, and an electrically insulating body having two opposing flat surfaces, and sliding the electrically insulating body relative to a first conductive body such that the flat surface of the electrically insulating body slides on the flat surface of the first conductive body; and sliding the flat surface of a second conductive body on the opposing flat surface of the electrically insulating body. The conductive bodies are preferably manufactured by wire electrical discharge machining. The respective flat portions of the conductive bodies are preferably formed by fork-shaped elements of their supporting portions.

[0047] According to one aspect of the invention, a support link includes two support portions respectively receiving two ends; the two ends are arranged to align to form a rotary pin joint, the rotary pin joint including a pin assembly comprising a first conductive half-pin electrically connected to a first conductive body and to a first end, and a second conductive half-pin electrically connected to a second conductive body and to a second end, and an electrically insulating element disposed between the first and second half-pins, such as a gap, air, or a glass sphere. The term "half-pin" is not necessarily intended to refer to a pin portion corresponding to half of the pin, such as half of its longitudinal extension.

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

[0049] According to one embodiment, the first half-pin and the second half-pin are separate portions of the same component (pin). According to one embodiment, the hinge pin includes a coating having a first conductive portion, a second conductive portion, and a third electrically insulating portion disposed longitudinally therebetween.

[0050] According to one aspect of the invention, the positioning rod or shaft comprises two rigid conductive bodies arranged coaxially, thereby autonomously forming two separate extensions of outward conduction and return paths. For example, the two rigid coaxial bodies may be two steel columns.

[0051] According to one aspect of the invention, a bipolar electrosurgical instrument includes a positioning rod having a distal portion; and a hinged end connected to the distal portion of the rod, the hinged end including two ends comprising conductive bodies, the two ends being hinged relative to the distal portion of the positioning rod and movable toward / away from each other; wherein the two ends are intended to be polarized with different charges; the positioning rod includes two conductive bodies arranged coaxially with each other to form two discrete conductive paths, each of the two discrete conductive paths of the positioning rod being conductively connected to an end.

[0052] As previously described, the positioning rod can be associated with the hinged end, allowing the two separate outward conduction and return paths of the bipolar electrosurgical instrument to pass through the body of the positioning rod and the body of the hinged 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 includes the following steps: (i) providing a composite workpiece comprising a first conductive body, a second conductive body and a cavity therebetween, and arranging an electrically insulating epoxy resin in the cavity; (ii) mounting the composite workpiece onto a wire electrical discharge machining machine including a cutting wire; and (iii) performing a first forming through-cut on the workpiece made of the composite material with the cutting wire to form a through seat for a hinge pin.

[0054] The method may further include: rotating the composite workpiece relative to the cutting line; and performing a second shaped through cut on the same composite workpiece by forming a second through seat for the second hinge pin.

[0055] For example, a support link is manufactured by electrical discharge wire cutting with two mutually orthogonal forming cuts, and an electrically insulating body is fixed to a conductive body in the form of adhesive resin before any forming cuts are performed, thereby creating a composite workpiece. Preferably, the electrically insulating body includes an inclined extension portion that is neither parallel to the rotation axis of the proximal rotator joint nor parallel to the rotation axis of the distal rotator joint, and, for example, the inclined extension portion is located near or at the proximal rotator joint.

[0056] According to one aspect of the invention, an electrically insulating assembly is provided for separating two conduction paths of a hinged end of a bipolar electrosurgical instrument. The hinged end is preferably a miniaturized hinged end suitable for microsurgery. The hinged end defines at least two rotary pin joints, each rotary pin joint including a pin assembly comprising two conductive half-pins. The electrically insulating assembly includes an electrically insulating body defining two orthogonal pin joints of the at least two rotary pin joints as a single piece, and an electrically insulating element inserted between the two half-pins. The electrically insulating element and the two conductive half-pins may belong to the same pin component, for example, in the form of a selectively insulating / conductive coating on the longitudinal body of the hinged pin. Attached Figure Description

[0057] Further features and advantages of the invention will become apparent from the following description of preferred embodiments given by way of non-limiting indication, with reference to the accompanying drawings, which are briefly described below. Note that references to “one” embodiment in this disclosure do not necessarily refer to the same embodiment and should be understood as at least one. Furthermore, for the sake of brevity and to reduce the total number of drawings, a single drawing may be used to illustrate features of more than one embodiment, and not all elements of the drawing may be necessary for a particular embodiment.

[0058] Figure 1A This is an operational diagram of a bipolar electrosurgical instrument according to one embodiment.

[0059] Figure 1B It is an isometric drawing of a robotic system used for remote operation in medical or surgical settings.

[0060] Figure 2A This is an isometric view of a bipolar electrosurgical instrument according to one embodiment.

[0061] Figure 2B It shows Figure 2A The details are indicated by circle B.

[0062] Figure 3A This is an isometric view of the articulated end of a bipolar electrosurgical instrument according to one embodiment, wherein some parts are omitted for clarity.

[0063] Figure 3B and Figure 3C They are based on Figure 3A The vertical elevation view obtained from the perspective indicated by arrows B and C.

[0064] Figure 3D It is based on Figure 3C The cross-sectional view taken by the cutting plane indicated by arrow DD.

[0065] Figure 3E It is based on Figure 3BThe cross-sectional view taken by the cutting plane indicated by arrow EE.

[0066] Figure 4A This is an isometric view of the articulated end of a bipolar electrosurgical instrument according to one embodiment, wherein some parts are omitted for clarity.

[0067] Figure 4B and Figure 4C yes Figure 4A Axonometric sectional view of the hinged end.

[0068] Figure 5A A vertical elevation view of the articulated end of a bipolar electrosurgical instrument according to one embodiment is shown, wherein some parts are omitted for clarity.

[0069] Figure 5B It is based on Figure 5A The cross-sectional view taken by the cutting plane indicated by arrow BB.

[0070] Figure 5C It is based on Figure 3A The vertical elevation view obtained from the perspective indicated by arrow C.

[0071] Figure 5D It is based on Figure 5C The cross-sectional view taken by the cutting plane indicated by arrow DD.

[0072] Figure 6A This is an isometric view of a segment of a positioning rod or shaft according to one embodiment, wherein some parts are drawn with dashed lines for clarity.

[0073] Figure 6B This is a longitudinal sectional view of a positioning rod or shaft according to one embodiment.

[0074] Figure 6C A positioning rod or shaft according to one embodiment is schematically shown.

[0075] Figure 6D This is an isometric view of the proximal link according to one embodiment.

[0076] Figure 7A This is an isometric view of a support link according to one embodiment.

[0077] Figure 7B yes Figure 7A Axonometric view of the separate parts of the central support link.

[0078] Figure 8A This is a vertical elevation view of a support link according to one embodiment.

[0079] Figure 8B It is based on Figure 8AVertical elevation view from the perspective indicated by arrow B.

[0080] Figure 8C yes Figure 8A Axonometric view of the separate parts of the central support link.

[0081] Figure 9A This is an isometric view of separate parts of some conductive portions of a support link according to one embodiment.

[0082] Figure 9B yes Figure 9A Vertical elevation view of the conductive body of the central support link.

[0083] Figure 9C It is based on Figure 9B The vertical elevation view obtained from the perspective indicated by arrow C.

[0084] Figure 10 This is an isometric view of the electrically insulating body of the support link according to one embodiment.

[0085] Figure 11 It is an isometric view of the end or end link according to one embodiment.

[0086] Figure 12A This is a cross-sectional view of a distal rotary joint having a hinge pin assembly according to one embodiment.

[0087] Figure 12B This is a cross-sectional view of a proximal rotary joint having a hinge pin assembly according to one embodiment.

[0088] Figure 13 This is a cross-sectional view of a distal rotary joint having a hinge pin assembly according to one embodiment.

[0089] Figure 14A This is an isometric view of the articulated end of a bipolar electrosurgical instrument according to one embodiment.

[0090] Figure 14B It is based on Figure 14A The viewpoint obtained by arrow B Figure 14A Vertical elevation view of the hinged end.

[0091] Figure 14C It is based on Figure 14B The view indicated by arrow C.

[0092] Figure 14D It is based on Figure 14C The cross-sectional view taken by the cutting plane indicated by arrow DD.

[0093] Figure 14E It is based on Figure 14CThe longitudinal sectional view is taken by the cutting plane indicated by arrow EE.

[0094] Figure 14F It is based on Figure 14C The cross-sectional view taken by the cutting plane indicated by arrow FF.

[0095] Figure 15A This is a view of the separate parts of a workpiece according to one embodiment.

[0096] Figure 15B yes Figure 15A A plan view of the workpiece, in which the cutting contour to be made is drawn.

[0097] Figure 15C It is based on Figure 15B The plan view obtained from the perspective indicated by the middle arrow C.

[0098] Figure 16A A support link according to one embodiment is shown, which can be drawn from... Figure 15B The workpiece is obtained from it.

[0099] Figure 16B A support link according to one embodiment is shown.

[0100] Figure 17 An electrical discharge wire cutting machine with a cutting line is schematically shown according to one embodiment.

[0101] Figure 18A This is a schematic cross-sectional view of the articulated end of a bipolar electrosurgical instrument according to one embodiment.

[0102] Figure 18B This is a schematic cross-sectional view of the articulated end of a bipolar electrosurgical instrument according to one embodiment.

[0103] Figure 19 This is an isometric view of the support link at the hinged end of a bipolar electrosurgical instrument according to one embodiment.

[0104] Figure 20 This is a schematic cross-sectional view of a hinge pin according to one embodiment. Detailed Implementation

[0105] References to "embodiment" in this specification mean that a particular feature, structure, or function associated with that embodiment is included in at least one embodiment of the invention. Therefore, the phrase "in one embodiment" in various parts of this specification does not necessarily refer to the same embodiment. Furthermore, in one or more embodiments, specific features, structures, or functions, such as those shown in the various figures, can be combined in any suitable manner.

[0106] According to a general embodiment, a bipolar electrosurgical instrument 1 (or instrument 1) is provided.

[0107] The bipolar electrosurgical instrument 1 is preferably adapted to a robotic medical or surgical remote operating system 100.

[0108] The bipolar electrosurgical instrument 1 includes a hinged end 2. Preferably, the bipolar electrosurgical instrument 1 includes a positioning rod or shaft 3 and a hinged end 2 connected to a distal portion 34 of the positioning rod or shaft. The bipolar electrosurgical instrument 1 further preferably includes a proximal transmission interface portion 4 (“rear end”) for operative connection with a robotic manipulator 5 of a robotic system 100 for remote medical or surgical operations. The proximal transmission interface portion 4 of the instrument 1 may include a connector 6 for receiving a bipolar cable, the other end of which is connected to a generator 17 for electrosurgical operations. The generator 17 for electrosurgical operations is preferably connected to a foot switch 18 located near or at the main control station 9 of the robotic system 100 for remote medical or surgical operations. A patient 8 lies on a bed 7 or operating table 7, which may be placed near the main control station 9. The bipolar connector 6 preferably includes two separate conductive paths separated by an electrical insulation layer inserted therebetween.

[0109] The articulated end 2 of the instrument includes a support link 10 and two ends 21, 22 (or end links or jaws) that are hinged to the support link 10 and are movable toward / away from the support link (e.g., when opening / closing). Thus, the articulated end includes a first end 21 (end link, jaw) and a second end 22 (end link, jaw), which are movable relative to each other when they are relatively close to / away from each other.

[0110] By providing two separate conduction paths, each extending separately through the hinged end 2, each of the two ends 21 or 22 of the bipolar electrosurgical instrument 1 is polarized with a different charge than the other end, for example, opposite charges, i.e., positive and negative charges. For example, the first end 21 is polarized with a positive charge, and the second end 22 is polarized with a negative charge. The corresponding conduction paths extend through the hinged end 2 and preferably also through the positioning rod or shaft 3.

[0111] Advantageously, the support link 10 comprises a multi-layered structure including two conductive bodies 11, 12 and at least one electrically insulating body 20 inserted therebetween. Thus, the two conductive bodies 11, 12 include a first conductive body 11 and a second conductive body 12, which are adapted to be polarized with different charges, such as opposite charges, because they are separated by the electrically insulating body 20. The electrically insulating body 20 is made, for example, of a ceramic material.

[0112] A further advantage is that each conductive body 11, 12 of the support link 10 includes a support portion 13, 14 electrically communicating with a corresponding end 21, 22 of the two ends. In other words, the first conductive body 11 of the support link 10 includes a first support portion 13 (“U-clamp”), for example, including two fork-shaped members, wherein the first end 21 is mounted to the first support portion 13 of the first conductive body 11, and wherein the second conductive body 12 of the support link 10 includes a second support portion 14 (“U-clamp”), for example, including two fork-shaped members, wherein the second end 22 is mounted to the second support portion 14 of the second conductive body 12.

[0113] Since this support link 10 includes two conductive bodies 11, 12 separated from each other by an electrically insulating body 20, wherein each conductive body 11, 12 is electrically connected to a corresponding end 21, 22 of the two ends of the hinge end 2, two separate conduction paths can be formed in the hinge end 2.

[0114] At the same time, it avoids the need to provide conductive cables (such as wires) embedded or integrated into the body of the support link, because the structure of the support link itself forms the two separate and unconnected conduction paths.

[0115] Therefore, by electrically activating the two conductive bodies 11, 12 of the support link 10, the two ends 21, 22 of the bipolar device 1 can be electrically activated. For example, conductive cables terminated on the two conductive bodies can be provided for this purpose. In the case where two separate conductive paths are also provided in the positioning rod or shaft 3, the two ends 21, 22 of the bipolar device 1 can be electrically activated by means of, for example, conductive cables terminated on the positioning rod or shaft 3.

[0116] According to a preferred embodiment, the support link 10 lacks internal degrees of freedom. In other words, both conductive bodies 11, 12 are fixed to the electrically insulating body 20 inserted therebetween, while remaining separate across the entire volume of the support link 10. The fastening of the conductive bodies 11, 12 to the electrically insulating body 20 can be performed in various ways, for example by gluing and / or welding. According to one embodiment, fastening occurs through interlocking. According to another embodiment, fastening is performed by providing a hinge pin combined with gluing.

[0117] Preferably, each end 21, 22 includes its operating portion 23, 24, free end 25, and attachment root 27, 28, wherein each attachment root 27, 28 is hinged to the support link 10 (e.g., hinged to the corresponding support portion 13 or 14), forming a conductive connection with the support link. For example, support portions 13 and 14 each include two fork-shaped pieces (“U-clamps”), and the corresponding attachment root 27, 28, which is substantially in the form of a disc, is inserted between the two fork-shaped pieces of the conductive body 11 or 12 and is in direct and close contact with it.

[0118] The electrical insulation body 20 may have a substantially plate-shaped portion 19.

[0119] Preferably, the electrically insulating body 20 is made of a single piece of ceramic material. The body of the insulating material 20 may be formed of multiple layers, which may be, for example, different materials, and these multiple layers are preferably electrically insulating.

[0120] The electrical insulation body 20 can be made of polymer material.

[0121] A rotary joint DJ can be disposed between the support link 10 and at least one of the two ends 21, 22, such that at least one end and the support portion of the corresponding conductive body of the support link 10 are constrained to rotate relative to each other about a common axis (deflection axis YY). Preferably, the two ends 21, 22 are constrained to rotate relative to the support link 10 about the same common axis (deflection axis or deflection YY). According to a preferred embodiment, the rotary joint between the support link 10 and each of the two ends 21, 22 includes at least one pin joint, wherein the hinge pin extends along the common axis of rotation (e.g., deflection axis or deflection YY).

[0122] According to one embodiment, as in, for example Figure 19 As shown, the distal rotational joint DJ may include rotational axes Y1 and Y2 for the end, which are parallel to each other but not aligned.

[0123] The hinge pin is preferably a hinge pin assembly 30, which includes at least two separate and non-communicating half-pins 31, 32. The two half-pins 31, 32 are preferably aligned with each other, i.e., arranged along an axis. The hinge pin 30 and each of its half-pins 31, 32 can be made of a conductive material, such as surgical steel. For example, the two half-pins 31, 32 of the hinge pin assembly 30 and the conductive bodies 11, 12 supporting the connecting rod 10 are made of the same conductive material.

[0124] Air can be inserted between the two half-pins 31, 32, thus providing a gap 33. A sphere 33 of electrically insulating material, such as a glass sphere with a diameter in the range of 0.2-0.5 mm, can be inserted between the two half-pins 31, 32. An element 33 made of electrically insulating material (such as paint droplets) can be inserted between the two half-pins 31, 32. For example, at least one half-pin 31, 32 may include a painted end portion, thereby forming an electrically insulating element 33.

[0125] According to one embodiment, as in, for example Figure 20 As shown, the conductive half-pins 31, 32 and the insulating material element 33 can be made by selectively coating individual hinge pins. For example, the hinge pin can be made of steel and includes a first electrically insulating coating and a second conductive coating on the insulating coating, wherein the longitudinal middle portion of the pin has no conductive coating. The coating pattern thus defines the insulating element 33 and the conductive elements 31, 32 (half-pins).

[0126] The inserted insulating material element preferably contacts the insulating material element 20 of the supporting link 10 so as to form an electrically insulating continuity with the insulating material body 20, and particularly with its plate-like portion 19. The insulating material element 33 between the two half-pins 31, 32 of the hinge pin assembly 30 may be formed from a layer of the insulating body 20. For example, the hole in the electrically insulating body 20 is a blind hole for receiving the hinge half-pins 31, 32.

[0127] According to one embodiment, two opposing hinged half-pins (not shown) each extend from the electrically insulating body 20, forming their pivot joints with corresponding ends 21, 22. The two opposing half-pins may be made of an electrically insulating material, for example, as a single piece with the insulating body 20, or made of a conductive material, for example, fastened to the insulating body 20.

[0128] According to a preferred embodiment, the electrically insulating body 20 of the support link 10 extends between the ends 21, 22. In other words, a portion of the electrically insulating body 20 extends in the axial direction of the deflection axis YY between the attachment roots 27, 28 of the ends 21, 22. According to one embodiment, the portion of the electrically insulating body 20 extending between the attachment roots 27, 28 of the ends 21, 22 includes a through-hole that is aligned (e.g., coaxial) with the through-holes of the attachment roots 27, 28 of the ends 21, 22 and with the through-holes of the support portions 13, 14 of the corresponding conductive bodies 11, 12 (e.g., each support portion includes two fork-shaped members). A hinge pin assembly 30 is inserted into the aligned through-hole, defining the distal rotary joint DJ of the support link 10.

[0129] On the proximal side, the support link 10 can be rigidly fastened to the positioning rod of the instrument 1 or the distal portion 34 of the shaft 3.

[0130] Alternatively, at least one proximal joint PJ may be provided to hinge the support link 10 relative to the distal portion 34 of the positioning rod or shaft 3.

[0131] According to a preferred embodiment, the support link 10 defines two orthogonal joints, including a proximal joint PJ and a distal joint DJ, such as a pitch joint PP and a yaw joint YY. Preferably, each rotary joint PJ, DJ is a rotary pin joint. According to one embodiment, each rotary joint PJ, DJ is defined by two opposing conductive support portions 13, 14, 15, 16 and an electrically insulating portion 19, 29 between them.

[0132] According to one embodiment, the proximal joint PJ constitutes the pitch joint of the hinged end 2. To define such a proximal pitch joint, the support link 10 may include two conductive proximal support portions 15, 16 belonging to the respective conductive bodies 11, 12, and an insulating support portion 29 belonging to the electrically insulating body 20 located therebetween. Preferably, the proximal support portions 15, 16 and the insulating support portion 29 of the respective conductive bodies 11, 12 all include through holes, and the through holes are aligned, for example, coaxial, to receive the hinge pin assembly 30. Preferably, the proximal support portions 15, 16 and the insulating support portion 29 of the respective conductive bodies 11, 12 all have substantially the same curved and convex profile (in a plane orthogonal to the pitch rotation axis PP).

[0133] According to one embodiment, the proximal joint PJ for hinged support link 10 relative to 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 a fork-shaped member or lug forming a support, thereby positioning the pitch axis PP. The distal portion 34 of the rod preferably includes a through hole coaxially arranged with the through holes of the conductive bodies 11, 12 of the support link 10 and the proximal support portions 15, 16, 29 of the insulating body 20, respectively. The hinge pin assembly 30 is preferably inserted into the coaxial through hole, thereby defining the pitch rotation axis PP.

[0134] As mentioned above, by providing two discrete conduction paths that extend separately through the hinged end 2, each of the two ends 21 or 22 of the bipolar electrosurgical instrument 1 is charged with a different charge than the other end, for example, opposite charges, i.e., positive and negative polarization. According to one embodiment, the two discrete conduction 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.

[0135] For this purpose, the distal portion 34 of the rod may include a single fork, while the other opposing fork may be made of a proximal link 35 fastened to the positioning rod 3.

[0136] Of course, the electrical insulating element 36 is preferably inserted between the distal portion 34 of the rod and the proximal link 35. According to one embodiment, the proximal link 35 includes a single support fork for the pitch axis PP, the support fork including a through hole for receiving the hinge pin assembly 30, such that the single fork of the proximal link 35 and the single fork of the distal portion 34 of the positioning rod 3 jointly support the pitch hinge pin.

[0137] The distal portion of the positioning rod 3 may include an internal hollow body, and the proximal link 35 may be mounted (e.g., fastened or keyed with one or more fastening pins 38) in the cavity 39 of the distal portion 34 of the rod. The positioning rod may further include two coaxial conductive elements 41, 42 (e.g., a sleeve 41 and a core 42) polarized with opposite charges, wherein a generally circularly extending electrical insulating element 36, such as a ring 36 or a sleeve 36, is inserted therebetween to form the two discrete conductive paths. The annular insulating element 36 may be formed from a centering bushing. The cavity 39 receiving the proximal link 35 may acquire conductivity through the curved sidewalls 26 supporting the link 35.

[0138] For example, only the core 42 performs the structural function, that is, it is fastened to the proximal rear end of the instrument, while the sleeve 41 of the rod 3 has only the electrical function, and vice versa.

[0139] According to one embodiment, the proximal link 35 is coaxially mounted with the distal portion 34 of the positioning rod 3, such that the individual forks of the distal portion 34 are at a greater radial height relative to the individual forks of the coaxial proximal link 35. In other words, in this embodiment, the forks defining the support for the pitch proximal joint PJ are asymmetrical, i.e., they are not equidistant from the longitudinal extension axis RR of the positioning rod or shaft 3. This can cause the corresponding conductive body 11 or 12 of the support link 10 to have a seat 37 for receiving the individual forks of the support link 35, while the opposing forks belonging to the distal portion 34 of the positioning rod 3 and positioned at the outermost radial level are not received in any seat.

[0140] The positioning rod or shaft 3 of the bipolar electrosurgical instrument 1 can itself form two discrete conductive paths for ends 21, 22 of different polarities. According to one embodiment, the positioning shaft or rod 3 includes an outer portion or sheath 41 made of a conductive material (such as surgical steel), and an inner portion 42 or core 42 made of a conductive material, wherein the outer portion or sheath 41 and the core 42 are polarized with different charges, and wherein the outer portion or sheath 41 is electrically connected to one end, and the inner portion 42 or core is electrically connected to the other end. As in, for example... Figures 6A-6BAs shown, the outer portion or sleeve 41 may form the single fork or lug of the distal portion 34 of the shaft and be electrically connected thereto, while the inner portion 42 or core may be electrically connected to the single fork or lug of the proximal link 35.

[0141] The outer portion 41 and inner portion 42 of the positioning rod or shaft 3 are preferably hollow and can be arranged coaxially with each other and with the longitudinal extension axis RR of the positioning rod or shaft 3. A gap 52 may be left between the outer portion 41 and the inner portion 42 and / or an electrically insulating material element 36, such as an insulating ring or sleeve, may be inserted. For example, a plurality of rings made of insulating material may be provided, arranged along the longitudinal extension of the positioning rod or shaft 3 and inserted between the sleeve 41 and the inner portion 42, while leaving a gap 52 of free space between the consecutive longitudinally spaced rings. The insulating ring or sleeve may be applied by casting. According to one embodiment, a hole or opening 43 is provided in the sleeve 41 for casting material, such as glue, suitable for simultaneously forming electrical insulation and a mechanical seal between the sleeve 41 and the inner portion 42 of the positioning rod or shaft.

[0142] The electrically insulating ring 36 may be made of one or more centering bushings made of polymeric material (e.g., PEEK or polyetheretherketone) to simplify the relative positioning of the sleeve 41 on the core 42 of the conductive positioning rod or shaft, which includes two separate conduction paths of the bipolar electrosurgical instrument 1.

[0143] For example, a hole or opening 43 can be provided in the sleeve 41 at the opening of the core 42 for inserting the fastening pin 38.

[0144] The positioning rod or shaft 3 is preferably coated with a layer of electrically insulating and preferably also thermally insulating material (e.g., sleeve 40). In other words, if the sleeve 41 is provided as being made of a conductive material, it may include a coating made of an electrically insulating material (e.g., silicone).

[0145] According to one embodiment, a protective cap 44 is provided to at least partially protect the articulated end 2 of the instrument 1 while exposing both ends 21, 22, wherein the free ends 25 of the ends are distally lateral to the protective cap 44. For example, the protective cap 44 includes two distal openings 51 for individually receiving the two ends 21, 22. The protective cap 44 is preferably made of a silicone material and is preferably elastically deformable (stretchable) to accommodate movement of the articulated end 2 while maintaining tight adhesion thereto. The protective cap 44 may form a fluid-impermeable closure on the articulated end and / or the positioning rod or shaft 3 to prevent fluids, vapors, and fumes from impacting the articulated end 2 under operating conditions. The protective cap 44 may include a one-piece sleeve 40 covering the positioning rod or shaft 3.

[0146] Preferably, an actuating rib 45 is provided for actuating the ends 21, 22 of the hinged ends 2 to open / close and deflect (distal rotary joint DJ). The actuating rib 45 extends from the transmission interface portion 4 along the positioning rod or shaft 3, preferably therein, i.e. inside the inner portion 42 or core, until it reaches the hinged ends 2, and is particularly provided in the end joint 46 in the body of the end links 21, 22 to be actuated.

[0147] For example Figures 3A-3D As shown, in order to move the first end 21 relative to the support link 10 about the deflection axis YY, and in particular to move the first end 21 relative to the support portion 13 of the first conductive body 11 of the support link 10, the actuating rib 45 is distally terminated in an end seat 46 disposed in the body of the attachment root 27 of the first end 21. The attachment root 27 or 28 typically forms a pulley portion, i.e., it includes a cylindrical surface, the distal portion of which the actuating rib is wound around near the end seat 46. The distal end of the actuating rib 45 may include a knot, protrusion, or other enlargement for achieving a dragging motion during rotation on the undercut wall of the end seat 46.

[0148] The actuating rib 45, terminated in the end seat 46 of the first end 21, extends through the hinged end 2 and, in particular, winds around the pulley portion 48 of the support portion 15 of the first conductive body 11 of the supporting link 10. When the actuating rib 45 pulls the first end 21, it slides on the pulley portion 48 of the support portion 15 of the first conductive body 11 of the supporting link 10. To facilitate the sliding of the rib 45, the pulley portion 48 includes a sliding surface with convex grooves formed by generatrices parallel to the pitch axis of rotation PP. Another actuating rib (not shown) for actuating the second end 22 relative to the support portion 14 of the second conductive body 12 of the supporting link 10 can be described by a reverse winding path, i.e., along the opposite winding direction, on the convex grooved surface of the pulley portion 48 of the proximal support portion 16. Additionally, the actuating rib 45 slides around the pulley portion 49 of the proximal connecting rod 35. To facilitate the sliding of the rib, the pulley portion 49 also includes a sliding surface with convex straight grooves formed by generatrices parallel to the pitch rotation axis PP. This straight groove surface, as well as the pulley portions 48 and 49, do not have guide channels or grooves for receiving the actuating rib.

[0149] The conductive bodies 11 and 12 supporting the connecting rod 10 may include other ruled sliding surfaces 50, and pulley portions 48 near their proximal support portions 15 and 16. According to one embodiment, each of the conductive bodies 11 and 12 includes a ruled sliding surface 50 formed by a generatrix parallel to the deflection rotation axis YY. Thus,

[0150] The support link 10 is preferably actuated by at least one of its actuating ribs (two opposing ribs) and may include an end joint 47 for receiving the action of the actuating rib. The end joint 47 of the support link 10 may be formed by means of a through hole in the electrically insulating body 20 (e.g., through in a direction parallel to the deflection axis of rotation YY). The conductive bodies 11, 12 are arranged such that the end joint 47, i.e., the through hole of the electrically insulating body 20, is accessible in the direction of the deflection axis YY, in other words, unobstructed.

[0151] The actuating rib 45 is a non-conductive actuating rib, and preferably a braided polymer rib. For example, the polymer rib is formed from braided high molecular weight polyethylene (UHMWPE) fibers. For example, the polymer rib is made of Kevlar. ® Therefore, the polymer actuating rib is not suitable for use as an electrical conductor, avoiding short circuits between the parts of the hinged ends 2 polarized with opposite charges. For example, the actuating rib of the second end 22 slides on the knurled surface of the pulley portion 49 of the proximal link 35 and on the pulley portion 48 of the second conductive body 12 supporting the link 10, which avoids conductive communication between the second conductive body 12 (which is in turn electrically connected to the distal portion 34 of the shaft) and the proximal link 35.

[0152] It provides a combination of polymer actuating ribs and a texturized convex sliding surface, allowing for extreme miniaturization of the hinged ends.

[0153] As mentioned above, the support link 10 preferably has no movable parts, i.e., it has no internal degrees of freedom. The electrically insulating body 20 can be fixed to and inserted between the two conductive bodies 11, 12 in various ways.

[0154] According to a preferred embodiment, the electrical insulating body 20 is inserted between the conductive bodies 11 and 12, and, with the proximal connecting rod 35 provided, contacts the conductive bodies at the proximal rotary joint PJ (pitch axis PP) and the distal rotary joint DJ (yaw axis YY) having ends 21 and 22. The electrical insulating body 20 includes flat positioning surfaces 61, 62, 63, and 64 for abutting against flat positioning mating surfaces disposed on the conductive bodies 11 and 12. Preferably, the electrical insulating body 20 includes a plate-like portion 19 having two opposing flat positioning surfaces 61 and 62, which are preferably parallel to each other and orthogonal to the yaw axis YY, and opposite to each other. The electrical insulating body 20 also includes a proximal support portion 29, which includes its two flat positioning surfaces 63 and 64, which are preferably parallel to each other and orthogonal to the pitch axis PP. The plate-like portion 19 may include deflection holes, blind holes, or through holes, and the proximal support portion 29 may include pitch holes, blind holes, or through holes. In addition to the distal edge 54, the plate-like portion 19 of the electrical insulating body 20 preferably includes opposing proximal edges 53. The proximal support portion 29 may extend proximally from the proximal edge 53 of the plate-like portion 19 of the electrical insulating body 20. The proximal edge 53 and the distal edge 54 of the plate-like portion 19 of the electrical insulating body 20 may be parallel to each other and have substantially the same extension in the lateral direction (parallel to the pitch axis), thereby forming a plate-like portion 19 with a generally quadrilateral (e.g., rectangular or square) or polygonal plane, forming an electrical insulating barrier between the two conductive bodies 11, 12 of the support link 10.

[0155] Preferably, the electrical insulating body 20 further includes at least one recess 55, 56, which is preferably positioned on the distal edge 54 of the electrical insulating body 20 to receive the distal arm or hook 57, 58 of the first or second conductive body 11 or 12. The recesses 55, 56 are preferably located on or near each flat positioning surface 61, 62 in the plate-like portion 19 of the electrical insulating body 20, and are also formed relative to their flat positioning surfaces 61, 62. The distal arm 57 of the first conductive body 11 thus defines a seat for receiving the recess 55 of the insulating body 20, and the distal arm 58 of the second conductive body 12 thus defines a seat for receiving the recess 56 of the insulating body 20.

[0156] The distal arms 57 and 58 of the conductive bodies 11 and 12 are allowed to be slidably assembled to the insulating body 20. Figure 7B , Figure 8CFurthermore, it simultaneously constrains the distal edge 54 of the insulating body 20 in a direction parallel to the deflection axis YY. In other words, the arrangement of opposing distal arms 57, 58 allows for a minimum reduction in the gap in the deflection axis direction at the level of the distal edge 54 of the insulating body, which helps to maintain precise operation of the conductive end even under low actuation force.

[0157] The axial recesses 55 and 56 of the separately receiving distal arms 57 and 58 (in the direction of the deflection axis YY) are arranged to maintain electrical insulation, i.e. to prevent the distal arm 57 of the first conductive body 11 from forming an electric arc with a portion of the conductive body 12 polarized with opposite charges.

[0158] Because of the provision of the distal arms 57, 58, a hinge pin assembly 30 with two separate and non-communicating half-pins can be used in the distal rotary joint DJ, since the constraint function of the deflection rotation axis YY direction of the distal rotary joint DJ is given by the distal arms.

[0159] The conductive bodies 11 and 12 may include a proximal seat 59 for receiving the proximal edge 53 of the plate-shaped body 19 of the electrically insulating body 20, the proximal seat being opposite to the distal arms 57 and 58. The proximal seat 59 is fitted to minimize the gap in the deflection axis YY direction.

[0160] According to one embodiment, the respective support portions 13, 14 of the conductive bodies 11, 12 each include flat positioning mating surfaces 65, 66, which are intended to abut against the respective flat positioning surfaces 61, 62 of the plate-like portion 19 of the electrically insulating body 19. The respective arms 57 or 58 preferably form folded segments facing the flat positioning mating surfaces 65 or 66. Preferably, the support portions 13, 14 of each conductive body 11, 12 include two fork-shaped members that define attachment seats 67, 68 between them for receiving attachment roots 27, 28 of the respective end links 21, 22, wherein one of the fork-shaped members includes its positioning mating surface 65, 66, which faces away from the attachment seats 67, 68.

[0161] According to one embodiment, the respective proximal support portions 15 and 16 of the conductive bodies 11 and 12 each include flat positioning mating surfaces 69 and 70 for abutting against the respective flat positioning surfaces 63 and 64 of the proximal support portion 29 of the electrically insulating body 20.

[0162] According to one embodiment, as in, for example Figures 9A-9CAs shown, the two conductive bodies 11 and 12 are made to be identical to each other. The two conductive bodies 11 and 12 can be manufactured by wire electrical discharge machining (WEDM) starting from a metal workpiece (e.g., surgical steel) on two mutually orthogonal cutting planes using the same cutting profile. This simplifies mass production while allowing for easy assembly of the conductive bodies 11 and 12 with the insulating body 20.

[0163] The electrical insulating body 20 can be made by sintering ceramic powder. The electrical insulating body 20 can be milled to form, for example, the recesses 55, 56.

[0164] The electrical insulation body 20 can be made of molded (micro-molded) polymer material.

[0165] The proximal link 35 with a single fork can be made by molding and milling a metal material (such as surgical steel).

[0166] The proximal rotatable joint PJ defining the pitch axis PP can therefore include proximal support portions 15 and 16 of conductive bodies 11 and 12 and proximal support portion 29 of insulating body 20, as well as separate fork-shaped members of proximal link 35 and distal portion 34 of the rod, all stacked together and in direct and close contact with each other. The hinge pin of the proximal rotatable joint PJ can be a hinge pin assembly 30 comprising two half-pins 31 and 32 made of conductive material, which are not electrically connected to each other. Thus, an electrical continuity path can be formed involving the proximal link 35, the corresponding proximal support portion 15 of the first conductive body 11, and the corresponding half-pin 31, as well as an electrical continuity path involving the distal portion 34 of the positioning rod 3, the corresponding proximal support portion 16 of the second conductive body 12, and the corresponding half-pin 32. The two conductive paths are electrically insulated by the electrically insulating portions 33 of the electrically insulating body 20 and the hinge pin assembly 30. The electrically insulating portion 33 of the hinge pin assembly 30 may include: air and / or an insulating body, such as a glass body, such as a glass sphere.

[0167] The distal rotary joint DJ defining the deflection axis YY can therefore include support portions 13 and 14 of conductive bodies 11 and 12, a plate-like portion 19 of insulating body 20, and attachment roots 27 and 28 of first and second ends 21 and 22, all stacked together and in direct and close contact with each other. The hinge pin of the distal rotary joint DJ can be a hinge pin assembly 30 comprising two half-pins 31 and 32 made of conductive material, which are not electrically connected to each other. Thus, an electrical continuity path can be formed involving the first conductive body and its support portion 13, the attachment root 27 of the first end 21, and the first half-pin 31, as well as an electrical continuity path involving the second conductive body and its support portion 14, the attachment root 28 of the second end 22, and the second half-pin 32. The two conductive paths are electrically insulated by the electrically insulating portions 33 of the electrically insulating body 20 and the hinge pin assembly 30. Towards the proximal side, the two conduction paths may continue to involve a first path: the proximal support portion 15 of the first conductive body, the first half-pin 31 and the proximal connecting rod 35, and a second path: the proximal support portion 16 of the second conductive body, the second half-pin 32 and the distal portion 34 of the positioning rod 3.

[0168] When the support link 10 is assembled, the seat 59 of each conductive body 11, 12 forms a proximal abutment for the proximal edge 53 of the plate-like portion 19 of the electrically insulating body 20, and the arms 57, 58 form a distal abutment for the distal edge 54 of the plate-like portion 19 of the electrically insulating body 20. In a direction parallel to the pitch axis PP, the flat positioning surfaces 63, 64 of the proximal support portion 29 of the electrically insulating body 20 abut against the corresponding flat positioning mating surfaces 69, 70 of the first and second conductive bodies, respectively. A single fork of the proximal link 35 can be received in close contact in the seat 37 of the proximal support portion 15 or 16 of the first or second conductive body 11 or 12. A single fork of the distal portion 34 of the positioning rod 3 (having the opposite charge relative to the proximal link 35) can be in close contact with the proximal support portion 16 or 15 of the second or first conductive body 12 or 11.

[0169] According to a preferred embodiment, an electrically insulating barrier is formed along the hinged end 2 of the bipolar electrosurgical instrument 1. This electrically insulating barrier includes the electrically insulating body 20 and the electrically insulating portion 33 of the hinge pin assembly 30 of the distal rotational joint DJ. Preferably, the electrically insulating barrier also includes the electrically insulating portion 33 of the hinge pin assembly 30 of the proximal rotational joint PJ, an insulating layer or ring 36 mounted to the distal portion 34 of the positioning rod, and an insulating gap disposed between the sleeve 41 and the inner portion 42 of the positioning rod 3.

[0170] For example, assembling the electrosurgical instrument 1 may include gluing the outer portion 41 and inner portion 42 of the positioning rod 3 by casting epoxy resin through the opening 43, such that the epoxy resin is distributed in the gap 52 between the outer portion 41 and the inner portion 42 of the rod. The proximal link 35 is then attached to the distal portion 34 of the rod, and a coaxial hole for the pitch rotation axis PP is drilled therein. At this point, the proximal link 35 can be removed from the positioning rod and assembled with the support link 10 and the ends 21, 22.

[0171] As mentioned above, according to one embodiment, the electrically insulating body 20 is manufactured separately from the conductive bodies 11 and 12 of the support link 10, and then the electrically insulating body 20 and the conductive bodies 11 and 12 are assembled together. For example, the insulating body 20 can be manufactured by molding and / or milling, the conductive bodies 11 and 12 can be manufactured by electrical discharge wire cutting on two orthogonal cutting planes, and the assembly can be performed by gluing and by using hinge pins.

[0172] According to another embodiment, the support link 10 can be entirely manufactured by wire electrical discharge machining (WEDM) on two mutually orthogonal cutting planes, and in this case, the workpiece may already include a composite multilayer structure 90, which includes an electrically insulating body 20 inserted between two conductive bodies 11, 12. As for example... Figure 15A The workpiece 90 shown, which is to be cut by wire electrical discharge machining (WEDM), can be a composite workpiece 90 comprising two conductive workpieces 91, 92 (e.g., metals, such as steel), which are suitably shaped to form a hollow seat therebetween, in which an electrically insulating material 93, such as an epoxy resin casting 93, is arranged. This epoxy resin casting serves both as an adhesive to maintain the adhesion of the conductive workpieces 91 and 92 during the wire electrical discharge machining step and as an electrically insulating element. Fastening devices can be provided to press the conductive workpieces 91, 92 against the epoxy resin 93.

[0173] The composite workpiece 90 with a multi-layered structure is preferably cut by the cutting line 98 of the wire EDM machine 99 on two mutually orthogonal cutting planes, and two orthogonal forming cuts CUT1 (forming cutting contour 1) and CUT2 (forming cutting contour 2) are performed on the composite workpiece, as shown in the image. Figure 15B and Figure 15C As shown in the diagram, the wire electrical discharge machining (EDM) forming cuts CUT1 and CUT2 are preferably through cuts on a composite workpiece 90. The composite workpiece 90 may include a cylindrical mounting portion 96 adapted to be inserted into a corresponding hole in the wire EDM tool. The cylindrical mounting portion 96 can be used to rotate the workpiece 90 individually between forming cuts CUT1 and CUT2; that is, a motor can be provided to rotate the cylindrical mounting portion 96 of the composite workpiece 90.

[0174] The insulating layer of epoxy resin 93 or other insulating material, i.e., the cavity between the two conductive workpieces 91, 92, can have a specific shape, which allows for the formation of a multilayer structure on the two portions defining the rotating pin joints PJ, DJ with mutually orthogonal axes. For this purpose, the cavity, i.e., the epoxy resin layer 93, can include a substantially flat portion 94, i.e., parallel to or orthogonal to the cutting line of the wire EDM 99, and an inclined portion 95, i.e., an inclined portion that is neither parallel to nor orthogonal to the cutting line 98. As for example... Figure 14D As shown, the inclined portion 95 of the insulating material allows for the arrangement of an insulating material layer 20 inclined relative to the pitch axis PP on the proximal swivel joint PJ of the support link 10, thereby obtaining two partially independent and separate conduction paths in the direction of the pitch axis PP (i.e., thus forming the proximal support portions 15, 16 of the conductive bodies 11, 12). Simultaneously, a flat portion 94 and the inclined portion 95 are provided in the form of a single piece, such that partially independent and separate conduction paths are formed in the direction of the deflection axis YY (i.e., thus forming support portions 13, 14 for the corresponding ends 21, 22).

[0175] Providing the inclined portion 95 makes the electrically insulating body 20 between the two conductive bodies 11, 12 supporting the link 10 more robust, or in any case more robust than the assumption that the orthogonal portion of epoxy resin is provided instead of the inclined portion 95.

[0176] The angle between the flat portion 94 and the inclined portion 95 is preferably in the range of 30°-60°, and even more preferably substantially 45°.

[0177] The above features, whether provided in combination or not in a specific embodiment, can satisfy the above requirements and achieve the above advantages, in particular:

[0178] - Provides a compact bipolar gripper;

[0179] - Bipolar electrical connection, i.e., bipolarization, is formed through the metal structure at the hinged end;

[0180] - This eliminates the need for cables to be routed through the movable joint (hinged end) on the outside of the end.

[0181] - The hinged end preferably includes a hinged sleeve with two orthogonal rotary pin joints;

[0182] - By avoiding external cables, stress and mechanical disturbances caused by the tension exerted by such cables during movement of the articulated end are avoided, thus allowing for the creation of highly compact articulated ends suitable for extremely miniaturization, and requiring low tension to actuate the movable parts (links) of the articulated end.

[0183] - An articulated end is formed that is resistant to the temperature and mechanical loads during active robotic surgery and is robust and durable;

[0184] - This avoids the need to use a dedicated control algorithm to compensate for any imbalance in the actuation force transmission at the articulated end, which could be caused by the ribs due to the aforementioned cables.

[0185] - By using actuating ribs, fine control over the degrees of freedom at the hinged ends is allowed;

[0186] - Select the size (thickness) of the electrically insulating body to avoid electric arcing between the conductive bodies 11 and 12 supporting the connecting rod;

[0187] - The hinge pin formed by the two half pins can be sized to avoid electric arcing between the two half pins and between the half pins and the electrically opposite conductive bodies of the support link.

[0188] - The longitudinal extension shape of the ends can be selected to minimize the risk of arcing between the ends outside their respective operating portions;

[0189] - If necessary, the need to install cables inside the cavity of the positioning rod or shaft can be avoided, because the bipolar electrical connection, i.e., bipolarization, is achieved through the coaxial metal structure of the positioning rod or shaft itself;

[0190] - The inner cavity of the positioning rod shaft can be occupied by the actuating rib of the rotary joint at the hinge end;

[0191] -The positioning rod or shaft can be formed by two coaxial rods or shafts with opposite charges;

[0192] - An internal rod or shaft can be fastened to a proximal link, for example, the proximal link is keyed in the cavity of the rod or shaft, generating electrical conduction through its side surface;

[0193] - It is possible to create support links with multi-layered structures, with an insulating layer between two conductive layers;

[0194] - Electrical conduction is achieved through a large contact surface including a conductive hinged half-pin;

[0195] - The diameter of the coaxial positioning rod or shaft can be easily made to be less than 5 mm;

[0196] - Bipolar electrosurgical instruments are suitable for operation in cutting and coagulation modes and combinations thereof, allowing for application in vascular sealing of vessels with diameters even less than 2 mm.

[0197] - Bipolar electrosurgical instruments are particularly suitable for extreme miniaturization of articulated ends, while ensuring electrical decoupling of outward and return strokes and satisfactory robustness under operating conditions.

[0198] As is well known, the combination of features disclosed in the appended claims forms part of this disclosure.

[0199] To meet specific or occasional needs, those skilled in the art can make some changes and adjustments to the above embodiments, and can replace the elements with other functionally equivalent elements without departing from the scope of the appended claims.

[0200] List of reference numerals

[0201]

[0202]

[0203]

[0204]

Claims

1. A bipolar electrosurgical instrument (1), the bipolar electrosurgical instrument comprising a hinged end (2), the hinged end comprising: Support link (10), and A first end (21) is movable relative to the support link (10) and has a conductive body having its own operating portion; The second end (22) is movable relative to the support link (10) and has a conductive body having its own operating portion; in: The operating portion of the first end (21) and the operating portion of the second end (22) can move toward / away from each other; The support link (10) has a multi-layer structure formed by a first conductive body (11), a second conductive body (12) and at least one electrically insulating body (20) therebetween; The first conductive body (11) of the support link includes a first support portion (13), and the first end (21) is installed to the first support portion (13) and electrically connected thereto, thereby realizing a first conduction path toward the operating portion of the first end; The second conductive body (12) of the support link includes a second support portion (14), and the second end (22) is installed to the second support portion (14) and electrically connected thereto, thereby realizing a second conduction path toward the operating portion of the second end; The first and second conductive paths are separated from each other within the main body of the support link by means of at least one electrically insulating body (20).

2. The device according to claim 1, wherein, The first conductive body (11) and the second conductive body (12) of the support link (10) are each fixed integrally with the electrically insulating body (20); and preferably, the support link (10) has no internal degrees of freedom; and / or wherein, The conductive bodies (11, 12) are fixed to the electrically insulating body (20) while remaining separate from each other over the entire volume of the support link (10).

3. The apparatus according to claim 1 or 2, wherein, The electrically insulating body (20) is inserted between the first conductive body (11) and the second conductive body (12) over the entire extension of the first conductive body (11) and the second conductive body (12).

4. The apparatus according to any one of the preceding claims, wherein, The first support portion (13) and the first end (21) of the first conductive body (11) of the supporting link are constrained to rotate about the rotation axis, and wherein, The second support portion (14) and the second end (22) of the second conductive body (12) of the support link are constrained to rotate about their own axis of rotation, which may be parallel to or aligned with the axis of rotation, thereby defining the distal rotation joint (DJ) of the hinge end (2), which has a multi-layer structure made of two conductive bodies and the electrically insulating body therebetween.

5. The device according to claim 4, wherein, The first support portion (13) and the second support portion (14) each include at least one fork-shaped member made of conductive material, and preferably, they each include a pair of fork-shaped members made of conductive material.

6. The apparatus according to claim 4 or 5, wherein, The first conductive body (11) of the support link (10) includes a first proximal support portion (15), and wherein, The second conductive body (12) of the supporting link includes a second proximal support portion (16). The first proximal support portion and the second proximal support portion cooperate with each other to define the proximal rotation joint (PJ) of the hinge end (3), which has the multilayer structure made of two conductive bodies and the electrically insulating body therebetween.

7. The device according to claim 6, wherein, The proximal rotation joint (PJ) has a proximal rotation axis (PP) orthogonal to the rotation axis, thereby forming a multilayer structure made of two conductive bodies and the electrically insulating body therebetween in two mutually orthogonal directions.

8. The apparatus according to any one of claims 4 to 7, wherein, The at least one rotary joint is a pin rotary joint, which includes a hinge pin assembly (30) comprising: The first conductive half-pin (31) is electrically connected to the first conductive body (11) and to the first end (21), and The second conductive half-pin (32) is electrically connected to the second conductive body (12) and to the second end (22); An electrical insulating element (33), such as a gap, air, or a sphere made of glass, is provided between the first half-pin (32) and the second half-pin (32); Preferably, the first half-pin (31) and the second half-pin (32) are separate from each other and not connected.

9. The apparatus according to any one of the preceding claims, wherein, Each of the two rotary joints (PJ, DJ) is actuated by means of one or more actuating ribs, which are preferably made of a non-conductive material, such as woven polymer fibers.

10. The device according to any one of the preceding claims, further comprising a positioning shaft (3) comprising two coaxially arranged conductive rigid bodies, such as two steel columns, thereby forming a segment of the two non-communicating conductive paths; and wherein, Preferably, the support link (10) is hinged to the positioning shaft (3) in the proximal rotary joint (PJ).

11. The apparatus according to any one of the preceding claims, wherein, The two conductive bodies (11, 12) are manufactured by wire electrical discharge machining using two mutually orthogonal and substantially identical forming cuts, thereby obtaining two substantially identical conductive bodies; and preferably, The two conductive bodies (11, 12) are made as separate pieces and then assembled to the electrically insulating body (20); and wherein, preferably, The electrically insulating body is, for example, molded into a single piece; and / or wherein... Each conductive body (11, 12) includes a distal arm (57, 58) that clamps the distal edge (54) of the electrically insulating body (20).

12. The apparatus according to any one of the preceding claims, wherein, The electrical insulation body (20) includes a plate-like portion (19) extending between the ends (21, 22) of the hinged ends and the proximal support portion (29); and / or wherein, Each of the conductive bodies (11, 12) includes at least two sliding surfaces (48, 50) for actuating ribs at the respective ends (21, 22); the sliding surfaces (48, 50) are convex ruled surfaces with straight parallel generatrices, wherein the parallel generatrices of one sliding surface (48 or 50) are orthogonal to the parallel generatrices of the other sliding surface (50 or 48); and preferably, The parallel generatrix of one sliding surface (48) is parallel to the rotation axis of the proximal rotary joint (PJ), and the parallel generatrix of the other sliding surface (50) is parallel to the rotation axis of the distal rotary joint (DJ); and / or wherein, The electrical insulating body (20) is made of a ceramic material, for example by sintering powder; and / or the electrical insulating body (20) is made of a polymer material, for example by molding; and / or wherein, The electrically insulating body includes at least two sliding surfaces (48, 50) for actuating the ribs, wherein the sliding surfaces (48, 50) are both convex ruled surfaces with straight parallel generatrices, wherein the parallel generatrices of one sliding surface (48 or 50) are orthogonal to the parallel generatrices of the other sliding surface (50 or 48).

13. The apparatus according to any one of the preceding claims, wherein, The support link (10) is made by electrical discharge wire cutting with two mutually orthogonal forming cuts (CUT1, CUT2); and wherein, Prior to any shaping or cutting, the electrically insulating body is fixed to the conductive body in the form of adhesive resin, thereby forming a composite multilayer workpiece (90); and wherein, preferably, The electrically insulating body includes a portion having an inclined extension, which is neither parallel to the axis of rotation of the proximal rotator joint (PJ) nor parallel to the axis of rotation of the distal rotator joint (DJ); and preferably, the portion having an inclined extension is located near or at the proximal rotator joint (PJ).

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

15. A method for manufacturing a support link (10) for an electrosurgical instrument by wire electrical discharge machining, comprising the following steps: - Provide a composite workpiece (90) comprising a first conductive body, a second conductive body and a cavity therebetween, and an electrically insulating epoxy resin disposed in the cavity; - The composite workpiece is mounted onto an electrical discharge wire cutting machine (99) including a cutting wire (98). - A first forming through cut is performed on the composite workpiece using the cutting line (98) to form a through seat for the hinge pin.

16. The method of claim 15, further comprising the following steps: - Rotate the composite workpiece relative to the cutting line; - Perform a second forming through-cut on the same composite workpiece to form a second through seat for the second hinge pin; and / or among them, The cavity comprises a substantially flat portion and a substantially sloping portion.

17. A bipolar electrosurgical instrument (1), the bipolar electrosurgical instrument comprising a hinged end (2), the hinged end comprising: Support link (10), and Two ends (21, 22), each end comprising a conductive body, are hinged to the support link (10) and are movable away from / towards each other; in: The support link (10) includes two support parts (13, 14) respectively installed at the two ends. The two ends are arranged adjacent to each other to form a rotary pin joint (DJ), which includes a pin assembly (30) comprising: The first half-pin (31) constrains the first end (21) to rotate relative to the first support portion (13) of the support link. The second half-pin (32) constrains the second end (22) to rotate relative to the second support portion (14) of the support link. Furthermore, an electrical insulation barrier (33) is provided between the first half-pin (31) and the second half-pin (32); for example, the electrical insulation barrier (33) includes at least one of a gap, air, a sphere made of glass, and a coating pattern.

18. A bipolar electrosurgical device (1), the bipolar electrosurgical device comprising: Positioning shaft with distal portion (3); The hinged end (2) is connected to the distal portion of the shaft and includes two ends (21, 22) that include conductive bodies. The two ends are hinged relative to the distal portion of the positioning shaft and are movable away from / towards each other. in: The two ends (21, 22) are intended to be polarized with different charges; The positioning shaft (3) includes two coaxially arranged conductive bodies, thereby forming two discrete conductive paths, each of the two discrete conductive paths of the positioning shaft (3) being electrically connected to one of the two ends (21 or 22).

19. An electrical insulation assembly for separating two conductive paths of a hinged end (2) of a bipolar electrosurgical instrument (1), the hinged end defining at least two rotary pin joints, each rotary pin joint including a pin assembly (30) comprising two conductive half-pins (31, 32). The electrical insulation component includes: An electrical insulating body (20) defines, in the form of a single piece, two mutually orthogonal pin joints (PJ, DJ) of the at least two rotary pin joints. An electrical insulating element (33) is inserted between the two half pins.

20. A method for assembling a support link (10) for an electrosurgical instrument, comprising the following steps: - Provide two conductive bodies (11, 12) and an electrically insulating body (20), each conductive body having a flat surface (65, 66), and the electrically insulating body having two opposing flat surfaces (61, 62). - Slide the electrical insulating body (20) relative to the first conductive body (11) so that the flat surface (61) of the electrical insulating body slides onto the flat surface of the first conductive body; - Slide the flat surface of the second conductive body onto the opposite flat surface of the electrically insulating body.

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