IT202300017115A1 - BIPOLAR ELECTROSURGICAL INSTRUMENT FOR MEDICAL-SURGICAL TELEOPERATION AND MANUFACTURING METHOD - Google Patents

Description

DESCRIPTION of the industrial invention entitled:

"Bipolar electrosurgical instrument for medical-surgical teleoperation and manufacturing method?

DESCRIPTION

[0001]. Field of the invention

[0002]. The subject of this invention is an electrosurgical instrument.

[0003]. In particular, the present invention relates to a bipolar electrosurgical instrument.

[0004]. The invention also relates to a robotic system for medical or surgical teleoperation comprising said instrument.

[0005]. Furthermore, the present invention relates to a method of manufacturing said instrument.

[0006]. The invention also relates to an electrical insulation assembly for an electrosurgical instrument.

[0007]. State of the art

[0008]. 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 includes a motorized positioning system (or manipulator) for moving a surgical instrument attachable distally to it for the purpose of performing surgical procedures on a patient. The patient typically lies on an operating table located in the operating room, where sterility is ensured to avoid bacterial contamination from non-sterile parts of the robotic device.

[0009]. Generally, known surgical instruments for tele-operated robotic surgery comprise a proximal transmission interface (or 'backend', according to a terminology commonly adopted in the field) having an interface intended to be operated by a robotic manipulator. Extending from the proximal interface is an elongated element such as a rod or shaft having at its distal end an articulated device (e.g., a robotic wrist) with an operating terminal end (e.g., needle holder, scissors, dilator, scalpel).

[0010], In known surgical instruments having an articulated cuff, it is typically composed of a plurality of links moved by a plurality of tendons (or actuation cables). One or more terminal links may have a free end forming the aforementioned operating terminal end, and are for example suitable for operating directly on the patient's anatomy and/or for handling a needle as well as a suture thread to perform anastomosis or other surgical therapies.

[0011]. Unlike known surgical instruments comprising an articulated cuff, surgical instruments are also known having an articulated device of the "snake" type, i.e. comprising a plurality of stacked vertebrae movable relative to each other by means of a plurality of actuation cables or tendons.

[0012]. For example, documents US-10582975 and WO-201 8-1 89721 in the name of the same Applicant disclose various embodiments of surgical instruments for robotic surgery and microsurgery designed to be subject to an extreme miniaturization of the articulated cuff and therefore of the operating end or end-effector, in which the links that make up the end-effector are made by wire electro-erosion.

[0013]. Also known are surgical instruments of the type suitable for transmitting electrical energy to tissue, such as electrocautery surgical instruments for robotic surgery. Some known examples of instruments of this type are shown in prior art documents US-6840938, US-7824401, US-10376331, US-8398634, US-10716617, and US-2022-133388.

[0014]. Known electrosurgical instruments typically comprise one or more conductors for transmitting electrical energy from the robotic manipulator, via the transmission interface portion of the surgical instrument, to the articulated ends of the end-effector of the instrument itself.

[0015], Such articulated electrosurgical instruments are usually made of electrically non-conductive and preferably highly thermally stable and insulating materials such as non-conductive plastics (e.g. ULTEM) or ceramics with the sole exception of the conductive metal ends on which the electrical conducting cables terminate.

[0016], Where all the articulated parts of the end-effector are made of metal, as well as the idle or fixed pulleys, as well as the movement actuation strands which are made of steel or tungsten, there is a risk of poor electrical insulation and the possibility of electrical voltage transfer to the entire articulated termination or even backwards, to the proximal transmission interface (?backend?), by conduction via the actuation cables. Also for these reasons, the active articulated terminals such well-known electro-surgical instruments are usually rather bulky and unsuitable for miniaturization.

[0017]. To electrically isolate such articulated ends of the active electrosurgical instrument, insulating sleeves are typically fitted over the entire end-effector, so as to form an electrically insulating barrier with respect to the patient's tissue in proximity to or in contact with the end-effector itself.

[0018], Particularly in the known electrocautery applications in laparoscopy, it is very important to avoid transmitting electrical energy to the fulcrum point, i.e., the point of insertion of the surgical instrument into its dedicated hole. This fulcrum point, under operating conditions, represents the center of rotation of the positioning rod or spindle with respect to the patient. For these reasons, the positioning rod itself is made of electrically insulating material or covered with an insulating layer (e.g., rubber) in order to avoid arcs with the internal abdominal wall.

[0019], Such articulated electrosurgical instruments, especially in endoscopic or minimally invasive applications, have an internally hollow positioning shaft made of non-conductive plastic or composite materials, to avoid unwanted lateral discharges, and only the electrically conductive cables running inside it in specific channels carry the potential to the application terminations (e.g. ?jaws?) made of metal and to which they are connected.

[0020], In fact, in monopolar electrosurgical instruments, an electrical cable is typically provided that extends inside the shaft or positioning rod of the surgical instrument from the transmission interface portion (backend) to the articulated cuff. The positioning rod is typically made of electrically insulating material while the operating tip of the electrosurgical instrument is electrically active in metal. In these well-known monopolar electrosurgical instruments, the electrical circuit is closed by a return electrode (typically a plate) after having passed through a part of the patient's body.

[0021], Conversely, in bipolar electrosurgical instruments, the two tips of the instrument are polarized with different charges, so as to form two electrodes, one of which forms the return electrode. In this type of electrosurgical instrument, short circuits must be avoided between the various parts of the end-effector that have different electrical charges (for example between the two tips as well as between the respective electrical conductors).

[0022], It is also known to use electrically insulating sleeves that are fitted onto the articulated cuff with the aim of preventing involuntary discharges of electrical energy from areas other than the termination (both mono- and bipolar instruments).

[0023], The known bipolar electrosurgical instrument solutions are unsuitable for a strong miniaturization at the level of the articulated terminal due to the presence of various components to be assembled such as electrical conductive means to polarize the tips (?jaws?) with opposite charge, electrical insulation means, return pulleys, actuation cables of the joints of the articulated terminal.

[0024], It is technically challenging to terminate or adhere conductive electrical wires to the tip terminal links of a miniaturized surgical instrument.

[0025], The stiffness and bulk of conductive cables connected to the jaws or articulated terminal tips compromises the handling, closing/opening and gripping performance, particularly in the case of miniaturized instruments.

[0026], ? therefore the need was felt to propose a tool

bipolar electrosurgical device suitable for extreme miniaturization.

[0027]. Solution

[0028], It is an object of the present invention to overcome the drawbacks complained of with reference to the state of the art and to propose a solution to the needs mentioned above.

[0029] This and other objects are achieved with an electrosurgical instrument according to claim 1, as well as with a robotic system according to claim 14, as well as with a manufacturing method according to claim 15, as well as with an electrosurgical instrument according to claim 17 or 18, as well as an insulation assembly according to claim 19, as well as with an assembly method according to claim 20.

[0030], Some advantageous embodiments are the subject of the dependent claims.

[0031], According to one aspect of the invention, a bipolar electrosurgical instrument comprises an articulated terminal comprising a support link, and a first tip movable relative to said support link and having an electrically conductive body with an operating portion thereof, and a second tip movable relative to said support link and having an electrically conductive body with an operating portion thereof.

[0032], The working portion of a tip may be a gripping and/or cutting surface and/or a free end, e.g., a sharp free end.

[0033], The working portion of the first tip and the working portion of the second tip can be moved towards/away from each other. In this way, the working portions of the tips can be moved open/closed relative to each other.

[0034], The support link has a multilayer structure consisting of a first electrically conductive body, a second electrically conductive body, and at least one electrically insulating body between them.

[0035], The first electrically conductive body of the support link comprises a first support portion and the first tip is mounted to said first support portion in electrically conductive communication with each other, providing a first conductive path, e.g., a conductive path to the operating portion of the first tip.

[0036], The second electrically conductive body of the same support link comprises a second support portion and the second tip is mounted to said second support portion in electrically conductive communication with each other, providing a second conductive path, e.g., a conductive return path from the working portion of the second tip.

[0037]. By providing the first conductive path and the second conductive path, the electrical circuit can be re-closed through the body of the bipolar surgical instrument, and in particular through its articulated terminal having two tips and a support link having a multilayer structure comprising an electrically insulating layer between two electrically conductive layers.

[0038], Said first forward conductive path and said second return conductive path are distinct from each other and separated in the body of the supporting link by said at least one electrically insulating body.

[0039] The support portions of the support link may each comprise at least one prong, and preferably two prongs, made of electrically conductive material.

[0040], Preferably, the support link is free of its own internal degrees of freedom.

[0041], The respective rotation axes of the tips are preferably aligned with each other. In accordance with one embodiment, the rotation axes of the tips are parallel to each other and spaced apart by a certain distance.

[0042] The articulating terminal may include other degrees of freedom, and the support link itself may be articulated relative to the positioning shaft or rod of the bipolar electrosurgical instrument while maintaining electrical insulation between its electrically conductive bodies. In accordance with one embodiment, the first electrically conductive body of the support link comprises a first proximal support portion, and wherein the second electrically conductive body of the support link comprises a second proximal support portion, said first proximal support portion and said second proximal support portion cooperating to define a proximal rotational joint of the articulating terminal having said multilayer structure formed by the two electrically conductive bodies and the electrically insulating body therebetween.

[0043], The proximal rotational joint preferably has a proximal rotation axis that is orthogonal to said rotation axis that articulates the tips to the support link, thus defining a multilayer structure formed by the two electrically conductive bodies and the electrically insulating body between them in two orthogonal directions, without interruption.

[0044], The manufacturing of the support link can be done by wire EDM of a workpiece made of material having a multilayer structure.

[0045], The manufacturing of the support link can be done by assembling separate pieces, where, for example, the electrically insulating body is made by stamping and the electrically conductive bodies are made by wire EDM.

[0046], Wire EDM manufacturing allows for the production of sliding surfaces for the actuation tendons to actuate at least one of the tips of the articulated terminal. Therefore, in accordance with one embodiment, the electrically conductive bodies each comprise at least two sliding surfaces for the actuation tendons of the respective tips; said sliding surfaces are all convex ruled surfaces with parallel generatrices, wherein the parallel generatrices of one sliding surface are orthogonal to the sliding surfaces of the other sliding surface of said two. Preferably, the parallel generatrices of one sliding surface are parallel to the rotation axis of a proximal rotational joint and the parallel generatrices of the other sliding surface are parallel to the rotation axis of a distal rotational joint of the articulated terminal of the bipolar electrosurgical instrument.

[0047]. The electrically insulating body of the support link may comprise a plate-like portion extending between the tips of the articulated terminal and a proximal support portion. In accordance with one embodiment, the electrically insulating body and in particular its proximal support portion, comprises at least two sliding surfaces (for actuation tendons and wherein said sliding surfaces are all convex ruled surfaces with parallel generatrices, wherein the parallel generatrices of one sliding surface are orthogonal to the sliding surfaces of the other sliding surface.

[0048], According to an embodiment, wherein the two electrically conductive bodies of the support link are made by wire EDM using two mutually orthogonal forming cuts substantially identical to each other, resulting in two electrically conductive bodies substantially identical to each other; and wherein, preferably, said two electrically conductive bodies are manufactured as separate pieces and subsequently assembled to the electrically insulating body.

[0049] According to one aspect of the invention, a method of assembling a support link for an electrosurgical instrument may be provided comprising the steps of providing two electrically 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 electrically conductive body such that a flat surface of the electrically insulating body slides on a flat surface of the first electrically conductive body; and sliding the flat surface of the second electrically conductive body on the opposing flat surface of the electrically insulating body. The electrically conductive bodies are preferably made by wire EDM. The respective flat portions of the electrically conductive bodies are preferably formed by a prong of their support portion.

[0050], According to one aspect of the invention, the support link comprises two support portions that receive the two tips, respectively; the two tips are arranged in alignment forming a pivot rotational joint comprising a pin assembly comprising a first electrically conductive half-pin in electrically conductive communication with the first electrically conductive body and the first tip, and a second electrically conductive half-pin in electrically conductive communication with the second electrically conductive body and the second tip, and between the first half-pin and the second half-pin is provided an electrically insulating element, such as a gap, air, a glass sphere. The term ?half-pin? is not necessarily intended to indicate a portion of the pin corresponding to half of the pin, for example half of its longitudinal development.

[0051], In accordance with one embodiment, said first semi-pin and said second semi-pin are made separate from each other.

[0052], In accordance with one embodiment, said first half-pin and said second half-pin are disjoint portions of the same component (pin). In accordance with one embodiment, the pivot pin comprises a covering having a first electrically conductive portion, a second electrically conductive portion, and a third electrically insulating portion disposed longitudinally therebetween.

[0053], According to one aspect of the invention, the positioning rod or spindle comprises two coaxially arranged electrically conductive rigid bodies, itself forming a section of the two distinct conductive outward and return paths. For example, the two coaxial rigid bodies may be two steel cylinders.

[0054], According to an aspect of the invention, a bipolar electrosurgical instrument comprises a positioning rod having a distal portion; and an articulated terminal connected to the distal portion of the rod, comprising two tips comprising an electrically conductive body, said two tips being articulated with respect to the distal portion of the positioning rod and movable in relative approach/distance; wherein said two tips are intended to be polarized with different electrical charges; the positioning rod comprises two electrically conductive bodies arranged coaxially with each other forming two distinct conductive paths, each conductive path of said two distinct conductive paths of the positioning rod being in electrically conductive communication with a tip.

[0055], The positioning rod may be associated with an articulated terminal as previously described, realizing said two distinct conductive paths for the forward and return of the bipolar electrosurgical instrument through the body of the positioning rod and the body of the articulated terminal.

[0056], According to one aspect of the invention, a method of manufacturing by wire EDM of a support link of an electrosurgical instrument comprising the following steps of: (i) providing a composite workpiece comprising a first electrically conductive body, a second electrically conductive body and a cavity therebetween, and placing electrically insulating epoxy resin in the cavity; (ii) mounting the composite workpiece to a wire EDM machine comprising a cutting wire; (iii) making a first through-forming cut with the cutting wire on the composite workpiece, providing a through-forming seat for a pivot pin.

[0057]. The method may further comprise: rotating the composite workpiece relative to the cutting edge; and making a second through-forming cut on the same composite workpiece providing a second through-forming seat for a second pivot pin,

[0058], For example, the support link is made by wire EDM with two mutually orthogonal forming cuts, and the electrically insulating body is bonded to the electrically conductive bodies in the form of an adhesive resin prior to making any forming cuts, resulting in a composite workpiece. Preferably, the electrically insulating body comprises a sloped portion that is neither parallel to the rotational axis of the proximal rotational joint nor to the rotational axis of the distal rotational joint, and for example said sloped portion is located in proximity to or at the proximal rotational joint.

[0059] According to one aspect of the invention, an electrical insulating assembly is provided for separating two conductive paths of an articulated terminal of a bipolar electrosurgical instrument. The articulated terminal is preferably a miniature articulated terminal, suitable for microsurgery. Said articulated terminal defining at least two pivot rotational joints, each pivot rotational joint comprising a pivot assembly comprising two electrically conductive half-pins, said electrical insulating assembly comprising an electrically insulating body defining, in a single piece, two orthogonal pivot joints of said at least two pivot rotational joints, and an electrically insulating element interposed between said two half-pins. The electrically insulating element and the two conductive half-pins may belong to the same pivot component, for example in the form of a selective insulating/conductive coating of the longitudinal body of the pivot pin.

[0060], Brief description of the figures

[0061] Further features and advantages of the invention will become apparent from the following description of preferred embodiments, given for illustrative and non-limiting purposes, with reference to the attached figures which are briefly described below. It should be noted that references to "an" embodiment in this disclosure do not necessarily refer to the same embodiment, and are intended to refer to at least one. Furthermore, for reasons of conciseness and reduction of the total number of figures, a given figure may be used to illustrate the features of more than one embodiment, and not all elements of the figure may be necessary for a given embodiment.

[0062], Figure 1A is a schematic diagram of the operation of a bipolar electrosurgical instrument, according to one embodiment.

[0063], Figure 1 B is an axonometric view of a robotic system for medical or surgical teleoperation.

[0064], Figure 2A is an axonometric view of a bipolar electrosurgical instrument, according to one embodiment.

[0065], Figure 2 B shows the detail indicated by circle B in Figure 2 A.

[0066], Figure 3A shows in axonometric view the articulated terminal of a bipolar electrosurgical instrument, according to one embodiment, in which some parts are omitted for clarity.

[0067]. Figures 3 B and 3 C are vertical elevation views obtained from the viewpoints indicated by arrows B and C, respectively, in Figure 3 A.

[0068], Figure 3D is a sectional view taken along the cutting plane indicated by arrows D-D in Figure 3C.

[0069], Figure 3 E is a sectional view taken along the cutting plane indicated by arrows E-E in Figure 3 B.

[0070]. Figure 4A shows in axonometric view the articulated terminal of a bipolar electrosurgical instrument, according to one embodiment, in which some parts are omitted for clarity.

[0071]. Figures 4B and 4C are axonometric sectional views of the articulated terminal of Figure 4A.

[0072]. Figure 5A shows a vertical elevation of the articulated terminal of a bipolar electrosurgical instrument, according to one embodiment, where some parts are omitted for clarity.

[0073], Figure 5 B is a sectional view taken along the cutting plane indicated by arrows B-B in Figure 5 A.

[0074]. Figure 5 C is a vertical elevation view obtained from the point of view indicated by the arrow C in Figure 3 A.

[0075]. Figure 5D is a sectional view taken along the cutting plane indicated by arrows D-D in Figure 5C.

[0076]. Figure 6A shows an axonometric view of a section of the positioning shaft or spindle, according to one embodiment, where some parts are drawn transparent for clarity.

[0077]. Figure 6B is a longitudinal sectional view of a locating rod or spindle, according to one embodiment.

[0078]. Figure 6 C schematically shows a positioning rod or spindle, according to one embodiment.

[0079]. Figure 6 D shows an axonometric view of a proximal link, according to one embodiment.

[0080]. Figure 7 A shows an axonometric view of a support link, according to one embodiment.

[0081]. Figure 7 B shows in axonometric and in separate parts the support link of figure 7 A.

[0082]. Figure 8A shows a vertical elevation of a support link, according to one embodiment.

[0083]. Figure 8 B is a vertical elevation view taken from the viewpoint indicated by arrow B in Figure 8 A.

[0084]. Figure 8 C shows in axonometric and in separate parts the support link of figure 8 A.

[0085]. Figure 9A shows in axonometric and in separate parts some electrically conductive portions of a support link, according to one embodiment.

[0086]. Figure 9 B shows in vertical elevation an electrically conductive body of the support link of Figure 9 A.

[0087]. Figure 9 C is a vertical elevation view taken from the viewpoint indicated by arrow C in Figure 9 B.

[0088], Figure 10 shows in axonometric view an electrically insulating body of a support link, according to one embodiment.

[0089], Figure 11 shows in axonometric view a tip or tip link, according to one embodiment.

[0090], Figure 12A shows in cross-section a distal rotational joint with a pivot pin assembly, according to one embodiment.

[0091], Figure 12 B shows in cross-section a proximal rotational joint with a pivot pin assembly, according to one embodiment.

[0092], Figure 13 shows in cross-section a distal rotational joint with a pivot pin assembly, according to one embodiment.

[0093], Figure 14 A shows in axonometry an articulated terminal of a bipolar electrosurgical instrument, according to one embodiment.

[0094], Figure 14 B is a vertical elevation view of the articulated terminal of Figure 14 A obtained from the viewpoint indicated by arrow B in Figure 14 A.

[0095], Figure 14 C is a view from the point of view indicated by the arrow C in Figure 14 B.

[0096], Figure 14 D is a cross-sectional view taken along the cutting plane indicated by arrows D-D in Figure 14 C.

[0097]. Figure 14 E is a longitudinal section view taken along the cutting plane indicated by arrows E-E in Figure 14 C.

[0098], Figure 14 F is a cross-sectional view taken along the cutting plane indicated by arrows F-F in Figure 14 C.

[0099], Figure 15A is a split view of a workpiece, according to one embodiment.

[00100], Figure 15 B is a plan view of the workpiece of Figure 15 A, in which the cutting profile to be produced is drawn.

[00101], Figure 15 C is a plan view obtained from the point of view indicated by arrow C in Figure 15 B.

[00102], Figure 16A shows a support link, according to one embodiment, obtainable from the workpiece of Figure 15B.

[00103], Figure 16B shows a support link, according to one embodiment.

[00104], Figure 17 schematically illustrates a wire EDM machine with a cutting wire, according to one embodiment.

[00105], Figure 18A is a schematic sectional view of an articulated terminal of a bipolar electrosurgical instrument, according to one embodiment.

[00106], Figure 18B is a schematic sectional view of an articulated terminal of a bipolar electrosurgical instrument, according to one embodiment.

[00107], Figure 19 is an isometric view of a support link for an articulated terminal of a bipolar electrosurgical instrument, according to one embodiment.

[00108], Figure 20 is a schematic sectional view of a pivot pin, according to one embodiment.

[00109], Detailed Description of Certain Embodiments Reference throughout this specification to ?an embodiment? is intended to indicate that a particular feature, structure, or function described in connection with the embodiment is included in at least one embodiment of the present invention. Therefore, the wording ?in an embodiment? in various parts of this specification do not necessarily all refer to the same embodiment. Furthermore, particular features, structures, or functions such as those illustrated in different figures may be combined in any suitable manner in one or more embodiments.

[00110], In accordance with a general embodiment, a bipolar electrosurgical instrument 1 (or instrument 1) is provided.

[00111], The bipolar electrosurgical instrument 1 is preferably suitable for a medical or surgical teleoperation robotic system 100.

[00112], The bipolar electrosurgical instrument 1 comprises an articulated terminal 2. Preferably, the bipolar electrosurgical instrument 1 comprises a positioning shaft or post 3 and the articulated terminal 2 connected to a distal portion 34 of the positioning shaft or post. The bipolar electrosurgical instrument 1 further preferably comprises a proximal transmission interface portion 4 (?backend?) for operative connection to a robotic manipulator 5 of the robotic system 100 for medical or surgical teleoperation. The proximal transmission interface portion 4 of the instrument 1 may comprise a connector 6 for receiving a bipolar cable connected at the other end to an electrosurgery generator 17. The electrosurgery generator 17 is preferably in turn connected to a foot switch 18 which is positioned in proximity to or in correspondence with the master control station 9 of the robotic system 100 for medical or surgical teleoperation. The patient 8 lies on a bed 7 or operating table 7 which may be located in proximity to the master control station 9. The bipolar connector 6 preferably comprises two separate conductive paths which may be separated by an electrically insulating layer placed between them.

[00113]. The articulated terminal 2 of the instrument comprises a support link 10 and two tips 21, 22 (or tip links, ?jaws?) articulated to the support link 10 and movable in relative approach/distance (for example in opening/closing). Therefore, the articulated terminal comprises a first tip 21 (tip link, jaw) and a second tip 22 (tip link, jaw) which are movable with respect to each other in relative approach/distance.

[00114]. Each tip 21 or 22 of said two tips of the bipolar electrosurgical instrument 1 is polarized with a different electrical charge from the other tip, for example opposite, i.e. positive-negative, by providing two distinct conductive paths which both extend, disjointed, through the articulated terminal 2. For example, the first tip 21 is polarized with a positive electrical charge and the second tip 22 is polarized with a negative electrical charge. The respective conductive paths extend through the articulated terminal 2 and preferably also through the positioning rod or spindle 3.

[00115]. Advantageously, said support link 10 comprises a multilayer structure comprising two electrically conductive bodies 1 1 , 12 and at least one electrically insulating body 20 placed between them. In this way, the two electrically conductive bodies 1 1 , 12 comprising a first electrically conductive body 11 and a second electrically conductive body 12 are suitable to be polarized with different electrical charges from each other, for example opposite, because they are separated by the electrically insulating body 20 between them. The electrically insulating body 20 is made, for example, of ceramic material.

[00116], With further advantage, each electrically conductive body 11 , 12 of the support link 10 comprises a support portion 13 , 14 in electrically conductive communication with a respective tip 21 , 22 of said two tips. In other words, the first electrically conductive body 11 of the support link 10 comprises a first support portion 13 (?clevis?), for example comprising two prongs, wherein the first prong 21 is mounted to the first support portion 13 of the first electrically conductive body 11 , and wherein the second electrically conductive body 12 of the support link 10 comprises a second support portion 14 (?clevis?), for example comprising two prongs, wherein the second prong 22 is mounted to the second support portion 14 of the second electrically conductive body 12.

[00117], Thanks to such a support link 10 comprising two electrically conductive bodies 1 1 , 12 separated from each other by an electrically insulating body 20, in which each electrically conductive body 1 1 , 12 is in electrically conductive communication with a respective tip 21 , 22 of said two tips of the articulated terminal 2, it is possible to create two disjointed conductive paths in the articulated terminal 2.

[00118], At the same time, it is possible to avoid having to provide conductive cables (such as, for example, electrical wires) drowned or embedded inside the body of the support link because the structure of the support link itself forms two separate and disjointed conductive paths.

[00119], It is therefore possible to electrically activate the two tips 21, 22 of the bipolar instrument 1 by electrically activating the two electrically conductive bodies 11, 12 of the support link 10. For example, for this purpose, conductive cables terminated on said two electrically conductive bodies, respectively. Where the two separate conductive paths are also provided in the positioning rod or spindle 3, it is possible to electrically activate the two tips 21, 22 of the bipolar instrument 1 by, for example, conductive cables terminated on the positioning rod or spindle 3.

[00120], In accordance with a preferred embodiment, said support link 10 is devoid of internal degrees of freedom. In other words, the two electrically conductive bodies 11, 12 are both fixed to the electrically insulating body 20 placed between them, while remaining separated along the entire volume of the support link 10. The fixing of the electrically conductive bodies 11, 12 to the electrically insulating body 20 can occur in various ways and can, for example, occur by gluing and/or welding. In accordance with one embodiment, the fixing occurs by interlocking. In accordance with another embodiment, the fixing occurs thanks to the provision of the articulation pins in gluing conjunction.

[00121], Preferably, each tip 21, 22 comprises a working portion 23, 24 thereof, a free end 25 and an attachment root 27, 28, wherein each attachment root 27, 28 is articulated to the support link 10 (e.g. to the respective support portion 13 or 14) forming an electrically conductive connection therewith. For example, the support portions 13 and 14 each comprise two prongs (?clevis?) and the respective attachment root 27, 28, substantially in the form of a disc, is inserted between the two prongs of the conductive body 11 or 12 and comes into direct and intimate contact therewith.

[00122], The electrically insulating body 20 may have a substantially plate-like portion 19.

[00123], Preferably, said electrically insulating body 20 is made as a single piece of ceramic material. The insulating material body 20 may be formed from a plurality of layers which, for example, may be of different materials and which are preferably all electrically insulating.

[00124], The electrically insulating body 20 may be made of polymeric material.

[00125], A DJ rotational joint may be provided between the support link 10 and at least one of the two tips 21, 22, such that the at least one tip and the support portion of the respective electrically conductive body of the support link 10 are constrained to rotate relatively about a common axis (Y-Y yaw axis). Preferably, both tips 21, 22 are constrained to rotate relatively to the support link 10 about the same common axis (Y-Y yaw axis). In accordance with a preferred embodiment, the rotational joint between the support link 10 and each of the two tips 21, 22 comprises at least one pin joint wherein the pivot pin extends along said common axis of rotation (e.g., Y-Y yaw axis).

[00126], In accordance with one embodiment, as shown for example in figure 19, the distal rotational joint DJ may comprise rotation axes Y1, Y2 for the tips that are parallel to each other although not aligned.

[00127], The pivot pin is preferably a pivot pin assembly 30 comprising at least two half-pins 31 , 32 which are disjointed and separate from each other. The two half-pins 31 , 32 are preferably arranged aligned with each other, i.e. on axis. The pivot pin 30, as well as each of its half-pins 31 , 32 can be made of electrically conductive material, such as surgical steel. For example, the two half-pins 31 , 32 of the pivot pin assembly 30 and the electrically conductive bodies 11 , 12 of the support link 10 are made of the same electrically conductive material.

[00128], Air may be inserted between the two half-pins 31, 32, i.e. a gap 33 may be provided. A sphere 33 of electrically insulating material, such as a glass sphere with a diameter in the range 0.2-0.5 millimetres, may be inserted between the two half-pins 31, 32. An element 33 of electrically insulating material, such as a drop of paint, may be inserted between the two half-pins 31, 32. For example, at least one half-pin 31, 32 may comprise a painted end portion, thus forming the electrically insulating element 33.

[00129], In accordance with one embodiment, as shown for example in Figure 20, the conductive half-pins 31, 32 and the insulating material element 33 may be made by selectively coating a single pivot pin. For example, a pivot pin may be made of steel and comprise a first electrically insulating coating and a second electrically conductive coating over the insulating coating, wherein a longitudinally median portion of the pin is free of conductive coating. The coating pattern therefore defines the insulating element 33 and the conductive elements 31, 32 (half-pins).

[00130], The interposed insulating material element is preferably in contact with the insulating material element 20 of the support link 10, so as to form an electrically insulating continuity with said insulating material body 20, and in particular with its plate-like portion 19. The insulating material element 33 between the two half-pins 31, 32 of the pivot pin assembly 30 may be formed from a layer of the insulating body 20. For example, the holes of the electrically insulating body 20 are blind holes for receiving the pivot half-pins 31, 32.

[00131], In accordance with one embodiment, two opposing half-pins (not shown) extend from the electrically insulating body 20, each forming its own pivotal rotational joint with the respective tip 21, 22. The two opposing half-pins may be made of electrically insulating material, for example in one piece with the insulating body 20, or of electrically conductive material, for example fixed to the insulating body 20.

[00132], In accordance with a preferred embodiment, the electrically insulating body 20 of the support link 10 extends between the tips 21, 22. That is, a portion of the electrically insulating body 20 extends between the attachment roots 27, 28 of the tips 21, 22 in the axial direction of the yaw axis Y-Y. In accordance with one embodiment, said portion of the electrically insulating body 20 extending between the attachment roots 27, 28 of the tips 21, 22 comprises a through-hole that is aligned (e.g., coaxial) with the through-holes of the attachment roots 27, 28 of the tips 21, 22 and with the through-holes of the support portions 13, 14 (e.g., each comprising two prongs) of the respective electrically conductive bodies 11, 12. A pivot pin assembly 30 is inserted into said aligned through holes defining a distal rotational joint DJ of the support link 10.

[00133], Proximally, the support link 10 may be rigidly attached to the distal portion 34 of the positioning shaft 3 of the instrument 1 .

[00134], Alternatively, at least one proximal joint PJ may be provided to articulate the support link 10 relative to the distal portion 34 of the positioning rod or spindle 3.

[00135], In accordance with a preferred embodiment, the support link 10 defines two orthogonal joints comprising a proximal joint PJ and a distal joint DJ, e.g., a pitch joint P-P and a yaw joint Y-Y. Preferably, each rotational joint PJ, DJ is a pivot rotational joint. In accordance with one embodiment, each rotational joint PJ, DJ is defined by two opposed electrically conductive support portions 13, 14, 15, 16 and an electrically insulating portion 19, 29 between them,

[00136], In accordance with one embodiment, the proximal joint PJ provides the pitch joint of the articulated terminal 2. To define such proximal pitch joint, the support link 10 can comprising two electrically conductive proximal support portions 15, 16 belonging to the respective electrically conductive bodies 11, 12, and an insulating support portion 29 between them belonging to said electrically insulating body 20. Preferably, the proximal support portions 15, 16 of the respective electrically conductive bodies 11, 12 and the insulating support portion 29 all comprise a through hole and said through holes are all aligned (e.g. coaxial) to receive a pivot pin assembly 30. Preferably, the proximal support portions 15, 16 of the respective electrically conductive bodies 11, 12 and the insulating support portion 29 all have substantially the same curved, convex profile (in a plane orthogonal to the pitch rotation axis P-P).

[00137], In accordance with one embodiment, the proximal joint PJ for articulating the support link 10 relative to the positioning rod or spindle 3 is formed by a distal portion 34 of the positioning rod or spindle itself. Preferably, the distal portion 34 of the positioning rod or spindle 3 comprises a prong or ear that forms a support locating the pitch axis P-P. Said distal portion 34 of the rod preferably comprises a through-hole that is arranged coaxial with the through-holes of the proximal support portions 15, 16, 29 of the electrically conductive bodies 11, 12 and insulating bodies 20, respectively, of the support link 10. A pivot pin assembly 30 is preferably inserted into said coaxial through-holes thereby defining the pitch axis P-P.

[00138], As mentioned above, each tip 21 or 22 of said two tips of the bipolar electrosurgical instrument 1 is polarized with a different electrical charge from the other tip, for example opposite i.e. positive or negative, by providing two distinct conductive paths which both extend, disjointed, through the articulated terminal 2. In accordance with one embodiment, said two distinct conductive paths also extend for at least a portion of the positioning shaft 3, and in particular for at least the distal portion 34 of the shaft.

[00139], For this purpose, said distal portion of the rod 34 may comprise a single prong while the other opposite prong may be made from a proximal link 35 fixed to the positioning rod 3.

[00140], Of course, an electrically insulating element 36 is preferably interposed between the proximal link 35 and the distal portion 34 of the rod. In accordance with one embodiment, the proximal link 35 comprises a single supporting prong for the pitch axis P-P comprising a through hole for receiving the pivot 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 pivot pin.

[00141], The distal portion of the positioning rod 3 may comprise an internally hollow body and the proximal link 35 may be mounted (e.g., secured with one or more fixing pins 38 or keyed) into the internal cavity 39 of the distal portion 34 of the rod. The positioning rod in turn may comprise two coaxial conductive elements 41, 42 (e.g., cladding 41 and core 42) polarized with opposite electrical charges, with an electrically insulating element 36 of generally circular shape, such as a ring 36 or a sleeve 36, placed between them to provide said two distinct conductive paths. The annular insulating element 36 may be formed by a centering bushing. The internal cavity 39 which receives the proximal link 35 may provide electrical conduction through the curved side walls 26 of the support link 35.

[00142], For example, only the core 42 has a structural function, i.e. it is fixed to the proximal backend of the instrument, while the jacket 41 of the rod 3 has an exclusively electrical function, or vice versa.

[00143], In accordance with one embodiment, the proximal link 35 is mounted coaxially with the distal portion 34 of the positioning rod 3, causing the single prong of the distal portion 34 to be at a greater radial level than the single prong of the coaxial proximal link 35. In other words, in this embodiment the prongs defining the support for the proximal pitch joint PJ are asymmetrical, that is, they are not equidistant from the longitudinal development axis Fi-R of the positioning rod or spindle 3. This may cause the respective electrically conductive body 11 or 12 of the support link 10 to have a seat 37 to receive the single prong of the support link 35, while the opposite prong, belonging to the distal portion 34 of the positioning rod 3 and placed at a more external radial level, is not received in any seat.

[00144], The positioning shaft or spindle 3 of the bipolar electrosurgical instrument 1 can itself form the two distinct conductive paths for the tips 21, 22 with different polarities. In accordance with one embodiment, the positioning shaft or spindle 3 comprises an external portion or jacket 41, made of electrically conductive material, such as surgical steel, and an internal portion 42 or core 42, made of electrically conductive material, in which the external portion or jacket 41 and the core 42 are polarized with different electrical charges from each other, and in which the external portion or jacket 41 is in electrically conductive connection with one tip and the internal portion 42 or core is in electrically conductive connection with the other tip. As shown for example in figure 6 A-B, the external portion or jacket 41 can form said single prong or ear of the distal portion 34 of the rod and be in electrically conductive communication with it while the internal portion 42 or core may be in electrically conductive communication with the single prong or ear of the proximal link 35.

[00145], The external portions 41 and internal portions 42 of the positioning rod or spindle 3 are preferably both internally hollow and can be arranged coaxially with each other and coaxially with the longitudinal development axis R-R of the positioning rod or spindle 3. A gap 52 can be left between the external portion 41 and the internal portion 42 and/or an element of electrically insulating material 36 can be placed between the external portion 41 and the internal portion 42, such as an insulating ring or sleeve. For example, a plurality of rings of insulating material can be provided, arranged along the longitudinal extension of the positioning rod or spindle 3 and placed between the jacket 41 and the internal portion 42, while leaving a gap 52 of free space between successive rings spaced longitudinally from each other. The insulating ring or sleeve can be applied by casting. In accordance with one embodiment, holes or openings 43 are provided in the jacket 41 for pouring material, such as glue, capable of simultaneously forming electrical insulation and a mechanical seal between the jacket 41 and the internal portion 42 of the positioning rod or spindle.

[00146], The ring of electrically insulating material 36 may be made from one or more centering bushings of polymeric material (e.g., PEEK or polyether-ether-ketone), so as to simplify the relative positioning of the skirt 41 on the core 42 of the electrically conductive positioning rod or spindle comprising the two separate conductive paths for the bipolar electrosurgical instrument 1.

[00147], Holes or openings 43 may be provided in the jacket 41 in correspondence with openings in the core 42 for the insertion of fixing pins 38, for example.

[00148], The positioning rod or spindle 3 is preferably coated with a layer (e.g. a sleeve 40) of electrically insulating, and preferably also thermally insulating, material. In other words, where said jacket 41 is provided in electrically conductive material, it may comprise a coating of electrically insulating material, for example silicone.

[00149], In accordance with one embodiment, a protective cap 44 is provided to at least partially protect the articulated end 2 of the instrument 1 and simultaneously expose the two tips 21, 22 with their free ends 25 distally outside the protective cap 44. For example, the protective cap 44 includes two distal openings 51 to individually receive the two tips 21, 22. The protective cap 44 is preferably made of silicone material and is preferably elastically deformable (?stretchable?) to accommodate the movements of the articulated end 2 while maintaining an intimate adhesion therewith. The protective cap 44 may provide a fluid-tight seal over the articulated end and/or the positioning rod or spindle 3 to prevent fluids, vapors, and fumes from striking the articulated end 2 when in operating conditions. The protective cap 44 may comprise a single piece sleeve 40 to cover the rod or positioning shaft 3.

[00150], Preferably, to actuate the tips 21, 22 of the articulated terminal 2 in opening/closing, as well as in yaw (distal rotational joint DJ), actuation tendons 45 are provided. The actuation tendons 45 extend from the transmission interface portion 4 along the positioning rod or shaft 3, preferably inside it, i.e. inside the internal portion 42 or core, until they reach the articulated terminal 2, and in particular a termination seat 46 provided in the body of the tip link 21, 22 to be actuated.

[00151], As shown for example in figures 3 A-D, to move the first tip 21 with respect to the support link 10 around the yaw axis Y-Y, and in particular to move the first tip 21 with respect to the support portion 13 of the first electrically conductive body 1 1 of the support link 10, the actuation tendon 45 is terminated distally in the termination seat 46 provided in the body of the attachment root 27 of the first tip 21. The attachment root 27 or 28 generally forms a pulley portion, i.e. it comprises a cylindrical surface on which the distal portion of the actuation tendon is wound, in proximity to the termination seat 46. The distal end of the actuation tendon 45 may comprise a knot, a boss or other enlarged portion to perform a rotational dragging action on undercut walls of the termination seat 46.

[00152], Said actuation tendon 45 terminated in the termination seat 46 of the first tip 21 extends through the articulated terminal 2, and in particular is wrapped around a pulley portion 48 of the support portion 15 of the first electrically conductive body 11 of the support link 10. When the actuation tendon 45 pulls the first tip 21, it slides on the pulley portion 48 of the support portion 15 of the first electrically conductive body 11 of the support link 10. The pulley portion 48 comprises, to facilitate the sliding of the tendon 45, a sliding surface which is convex and ruled, formed by generating lines all parallel to the pitch rotation axis P-P. Another actuation tendon (not shown) for actuating the second tip 22 with respect to the support portion 14 of the second electrically conductive body 12 of the support link 10 can describe a reverse winding path, i.e. in the opposite direction of winding, on a convex ruled surface of the pulley portion 48 of the proximal support portion 16. In addition, the actuation tendon 45 also winds in a sliding manner around a pulley portion 49 of the proximal link 35, wherein this pulley portion 49 also comprises, to facilitate the sliding of the tendon, a sliding surface which is convex and ruled, formed by generating lines all parallel to the pitch rotation axis P-P. The ruled surfaces, as well as the pulley portions 48, 49, are free of guide channels or concave grooves to receive the actuation tendon.

[00153], The electrically conductive bodies 11, 12 of the support link 10 may comprise other ruled sliding surfaces 50, in addition to the pulley portions 48 of their proximal support portions 15, 16. In accordance with one embodiment, the electrically conductive bodies 11, 12 each comprise a ruled sliding surface 50 formed by generating lines parallel to the yaw rotation axis Y-Y. In this way,

[00154], The support link 10 is also preferably actuated by at least one of its actuation tendons (two opposing tendons) and may comprise a termination seat 47 to receive the action of the actuation tendon. The termination seat 47 of the support link 10 may be made by a through-hole in the electrically insulating body 20 (passing in a direction parallel to the yaw axis Y-Y, for example). The electrically conductive bodies 11, 12 are arranged such that the termination seat 47, i.e. the through-hole in the electrically insulating body 20, is accessible, in other words unobstructed, in the direction of the yaw axis Y-Y.

[00155], The actuation tendons 45 are electrically non-conductive actuation tendons and preferably are braided polymer tendons. For example, the polymer tendons are formed from fibers made of high molecular weight polyethylene (HMWPE) that are braided. For example, the polymer tendons are made of Kevlar. Therefore, the polymer actuation tendons are unsuitable for serving as electrical conductors, avoiding short circuits between oppositely charged polarized parts of the joint terminal 2. For example, the actuation tendon for the second tip 22 slides on a grooved surface of the pulley portion 49 of the proximal link 35 and slides on a pulley portion 48 of the second electrically conductive body 12 of the support link 10, avoiding placing said second electrically conductive body 12 (which in turn is in electrically conductive communication with the distal portion 34 of the shaft) and said proximal link 35 in electrically conductive communication.

[00156], The provision of polymeric actuation tendons in combination with the grooved and convex sliding surfaces allows for a significant miniaturization of the articulated terminal.

[00157], As mentioned above, the support link 10 is preferably free of moving parts, i.e., free of internal degrees of freedom. The electrically insulating body 20 can be fixed to the two electrically conductive bodies 11, 12 and interposed between them in various ways.

[00158], In accordance with a preferred embodiment, the electrically insulating body 20 is interposed between the electrically conductive bodies 11, 12 and in contact with them both at the proximal rotational joint PJ (pitch axis P-P) with the proximal link 35 where provided, and at the distal rotational joint DJ (yaw rotation axis Y-Y) with the tips 21, 22. The electrically insulating body 20 comprises flat positioning surfaces 61, 62, 63, 64 to abut against flat positioning counter-surfaces provided on the electrically conductive bodies 11, 12. Preferably, the electrically insulating body 20 comprises a plate-like portion 19 having two opposite flat positioning surfaces 61, 62, which are preferably parallel to each other and at the same time orthogonal to the yaw rotation axis. Y-Y, and facing opposite each other, said electrically insulating body 20 comprising a proximal support portion 29 comprising two of its flat positioning surfaces 63, 64 which are preferably parallel to each other and at the same time orthogonal to the pitch rotation axis P-P. The plate-like portion 19 may comprise a blind or through yaw hole, and the proximal support portion 29 a blind or through pitch hole. The plate-like portion 19 of the electrically insulating body 20 preferably comprises, in addition to the distal margin 54, an opposite proximal margin 53. The proximal support portion 29 may extend proximally in a cantilever manner with respect to the proximal margin 53 of the plate-like portion 19 of the electrically insulating body 20. The proximal margins 53 and distal margins 54 of the plate-like portion 19 of the electrically insulating body 20 may be parallel to each other and substantially of the same extension in the transverse direction (parallel to the pitch axis) so as to form a plate-like portion 19 with a generally quadrangular (e.g. rectangular or square) or polygonal plan, creating an electrically insulating barrier between the two electrically conductive bodies 11, 12 of the support link 10.

[00159], Preferably, the electrically insulating body 20 further comprises at least one recess 55, 56 which is preferably located on the distal edge 54 of the electrically insulating body 20 for receiving a distal arm or hook 57, 58 of the first or second electrically conductive body 11 or 12. A recess 55, 56 is preferably provided on or adjacent to each flat positioning surface 61, 62 of the plate-like portion 19 of the electrically insulating body 20, also forming a recess with respect to its flat positioning surface 61, 62. The distal arm 57 of the first conductive body 11 therefore defines a seat for receiving the recess 55 of the insulating body 20 and the distal arm 58 of the second conductive body 12 therefore defines a seat for receiving the recess 56 of the insulating body 20.

[00160], The distal arms 57, 58 of the electrically conductive bodies 1 1 , 12 allow assembly to the insulating body 20 by sliding (figure 7B, figure 8C) and at the same time form a constraint for the distal edge 54 of the insulating body 20 in a direction parallel to the yaw axis Y-Y. In other words, the provision of the opposing distal arms 57, 58 allows for the play in the direction of the yaw axis at the level of the distal edge 54 of the insulating body to be reduced to a minimum, helping to maintain the action of the electrically conductive tips precise, even with low actuation forces.

[00161], The axial recesses 55, 56 (in the direction of the yaw axis Y-Y) which individually receive the distal arms 57, 58 are arranged to maintain electrical isolation, i.e. to prevent a distal arm 57 of the first conductive body 11 from forming an electrical arc with a portion of the oppositely charged polarized conductive body 12.

[00162], Thanks to the provision of said distal arms 57, 58 it is possible to use pivot pin assemblies 30 having two separate and disjointed half-pins in the distal rotational joint DJ because the constraint function in the direction of the yaw rotation axis Y-Y of the distal rotational joint DJ is given by the distal arms.

[00163], The electrically conductive bodies 11, 12 may comprise a proximal seat 59 to accommodate the proximal margin 53 of the plate-like body 19 of the electrically insulating body 20 which is opposed to the distal arms 57, 58. The proximal seat 59 cooperates to minimize the play in the direction of the yaw axis Y-Y.

[00164], In accordance with one embodiment, the respective support portions 13, 14 of the electrically conductive bodies 11, 12 each comprise a flat positioning counter-surface 65, 66 intended to abut against the respective flat positioning surface 61, 62 of the plate-like portion 19 of the electrically insulating body 19. The respective arm 57 or 58, preferably, forms a folded section which ? facing the flat positioning countersurface 65 or 66. Preferably, the support portion 13, 14 of each electrically conductive body 11, 12 comprises two prongs defining an attachment seat 67, 68 between them for receiving an attachment root 27, 28 of a respective tip link 21, 22, wherein one of the two prongs comprises its positioning countersurface 65, 66 which faces oppositely to the attachment seat 67, 68.

[00165], In accordance with one embodiment, the respective proximal support portions 15, 16 of the electrically conductive bodies 11, 12 each comprise a flat positioning counter-surface 69, 70 for abutting a respective flat positioning surface 63, 64 of the proximal support portion 29 of the electrically insulating body 20.

[00166], In accordance with one embodiment, as shown for example in figures 9 A-C, the two electrically conductive bodies 11 , 12 are made identical to each other. Said two electrically conductive bodies 1 1 , 12 can be made by wire electro-discharge machining (WEDM) on two mutually orthogonal cutting planes starting from metal workpieces, for example surgical steel, using the same cutting profiles. This simplifies mass production while allowing easy assembly of the conductive bodies 1 1 , 12 with the insulating body 20.

[00167], The electrically insulating body 20 can be made by sintering ceramic powders. The electrically insulating body 20 can be machined by milling to create, for example, said recesses 55, 56.

[00168], The electrically insulating body 20 can be made by molding (?micro-moulding?) of polymeric material.

[00169], The proximal link 35 having a single prong may be made by stamping and milling metal material, such as surgical steel.

[00170], The proximal rotational joint PJ defining the pitch axis P-P may therefore comprise the proximal support portions 15, 16 of the conductive bodies 1 1 , 12, and the proximal support portion 29 of the insulating body 20, and the individual prongs of the proximal link 35 and the distal portion 34 of the rod all stacked in a pack and in direct and intimate contact with each other. The pivot pin of the proximal rotational joint PJ may be a pivot pin assembly 30 comprising two semi-pins 31 , 32 made of electrically conductive material which are not in electrically conductive communication with each other. This therefore allows for the creation of an electrical continuity path involving the proximal link 35, the respective proximal support portion 15 of the first conductive body 1 1 and the respective semi-pin 31 , and a continuity path electrically involving the distal portion 34 of the positioning rod 3, the respective proximal support portion 16 of the second conductive body 12 and the respective half-pin 32. Said two conductive paths are electrically insulated by providing the electrically insulating body 20 and the electrically insulating portion 33 of the pivot pin assembly 30. The electrically insulating portion 33 of the pivot pin assembly 30 may comprise: air and/or an insulating body such as, for example, a glass body, such as, for example, a glass sphere.

[00171]. The distal rotational joint DJ defining the yaw axis Y-Y may therefore comprise the support portions 13, 14 of the conductive bodies 11, 12, and the plate-like portion 19 of the insulating body 20, and the attachment roots 27, 28 of the first and second tips 21, 22 all stacked in a pack and in direct and intimate contact with each other. The pivot pin of the distal rotational joint DJ may be a pivot pin assembly 30 comprising two semi-pins 31, 32 made of electrically conductive material which are not in electrically conductive communication with each other. This therefore allows for the creation of an electrical continuity path involving the first electrically conductive body with its support portion 13 and the attachment root 27 of the first tip 21 and the first semi-pin 31, and a continuity path electrically involving the second electrically conductive body with its support portion 14 and the attachment root 28 of the second tip 22 and the second semi-pin 32. Said two conductive paths are electrically isolated by providing the electrically insulating body 20 and the electrically insulating portion 33 of the articulation pin assembly 30. Proximally, said two electrically conductive paths may continue involving for the first path the proximal support portion 15 of the first conductive body, the first semi-pin 31 and the proximal link 35, and for the second path the proximal support portion 16 of the second conductive body, the second semi-pin 32 and the distal portion 34 of the positioning rod 3.

[00172], When in the assembled support link 10 condition, the seat 59 of each conductive body 11, 12 forms a proximal abutment for the proximal margin 53 of the plate-like portion 19 of the electrically insulating body 20 and the arms 57, 58 form distal abutment for the distal margin 54 of the plate-like portion 19 of the electrically insulating body 20. In a direction parallel to the pitch axis P-P, the flat positioning surfaces 63, 64 of the proximal support portion 29 of the electrically insulating body 20 abut against the respective flat positioning countersurfaces 69, 70 of the first and second conductive bodies, respectively. The single prong of the proximal link 35 can be received with intimate contact in a seat 37 of the proximal support portion 15 or 16 of the first or second conductive body 11 or 12. The single prong of the distal portion 34 of the positioning rod 3, having an opposite charge with respect to the proximal link 35, can come into intimate contact with the proximal support portion 16 or 15 of the second or first conductive body 12 or 11.

[00173]. In accordance with a preferred embodiment, an electrically insulating barrier is formed along the articulating terminal 2 of the bipolar electrosurgical instrument 1 comprising said electrically insulating body 20, and the electrically insulating portion 33 of the pivot pin assembly 30 of the distal rotational joint DJ. Preferably, the electrically insulating barrier also comprises the electrically insulating portion 33 of the pivot pin assembly 30 of the proximal rotational joint PJ and the insulating layer or ring 36 mounted to the distal portion 34 of the positioning rod, as well as an insulating gap provided between the skirt 41 and the inner portion 42 of the positioning rod 3.

[00174]. For example, assembly of the electrosurgical instrument 1 may comprise gluing the outer portion 41 and the inner portion 42 of the positioning rod 3 by pouring epoxy resin through the openings 43 so that the epoxy resin is distributed in the gap 52 between the outer portion 41 and the inner portion 42 of the rod. Next, the proximal link 35 is mounted to the distal portion 34 of the rod and the coaxial holes for the P-P pitch rotation axis are drilled in them. At this point, the proximal link 35 may be extracted from the positioning rod and assembled with the support link 10 and the tips 21, 22.

[00175]. As mentioned above, in accordance with one embodiment, the electrically insulating body 20 is manufactured separately from the electrically conductive bodies 11, 12 of the support link 10 and subsequently the electrically insulating body 20 and the electrically conductive bodies 11, 12 are assembled together. For example, the manufacturing of the insulating body 20 may occur by stamping and/or milling, the manufacturing of the conductive bodies 11, 12 may occur by wire EDM on two orthogonal cutting planes, and the assembly may occur by gluing and by the use of pivot pins.

[00176]. In accordance with another embodiment, the support link 10 can be made entirely by wire electrical discharge machining (WEDM) on two mutually orthogonal cutting planes, and in this case the workpiece can already comprise a composite multilayer structure 90 comprising an electrically insulating body 20 placed between two electrically conductive bodies 11, 12. As shown for example in figure 15A, the workpiece 90, i.e. the piece to be cut by wire electrical discharge machining (WEDM), can be a composite workpiece 90 comprising two electrically conductive workpieces 91, 92 (e.g., made of metal, such as steel) suitably shaped to form a hollow seat between them in which an electrically insulating material 93 is placed, such as a casting of epoxy resin 93, which acts both as an adhesive to keep the electrically conductive workpieces 91 and 92 adhered during the wire EDM cutting phases, and as an electrically insulating element. Fastening means may be provided to clamp the conductive workpieces 91, 92 together with the epoxy resin 93.

[00177]. The composite workpiece 90 having the multilayer structure is preferably cut with the cutting wire 98 of the wire EDM machine 99 on two mutually orthogonal cutting planes, making two orthogonal forming cuts CUT1, CUT2 on the composite workpiece, as shown for example in figures 15B and 15C. The forming cuts CUT1, CUT2 by wire EDM are preferably through cuts on the composite workpiece 90. The composite workpiece 90 may comprise a cylindrical mounting portion 96, suitable for being inserted into a respective hole of a wire EDM machine fixture. The cylindrical mounting portion 96 may be used to individually rotate the workpiece 90 between the forming cuts CUT1, CUT2, i.e. it may a motor may be provided that rotates the cylindrical mounting portion 96 of the composite workpiece 90.

[00178]. 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 particular shape that allows the multilayer structure to be created on two portions defining pivot rotational joints PJ, DJ with mutually orthogonal axes. For this purpose, the cavity, i.e. the layer of epoxy resin 93, can comprise a substantially flat portion 94, i.e. parallel or orthogonal to the cutting edge of the EDM machine 99, and an inclined portion 95, i.e. oblique, which is neither parallel nor orthogonal to the cutting edge 98. As shown for example in figure 14D, the inclined portion 95 of insulating material allows a layer of insulating material 20 to be arranged on the proximal rotational joint PJ of the support link 10, which is inclined, i.e. oblique, to be placed on the proximal rotational joint PJ of the support link 10. oblique with respect to the pitch axis P-P, thus obtaining two distinct and separate conductive paths, locally, in the direction of the pitch axis P-P (i.e. thus realizing the proximal support portions 15, 16 of the conductive bodies 11, 12). At the same time, the provision of the flat portion 94 in a single piece with said inclined portion 95 realizes the distinct and separate conductive paths, locally, in the direction of the yaw axis Y-Y (i.e. thus realizing the support portions 13, 14 for the respective tips 21, 22).

[00179]. The provision of the inclined portion 95 makes the electrically insulating body 20 between the two electrically conductive bodies 11, 12 of the support link 10 robust, or in any case more robust than the hypothesis of providing an orthogonal portion of epoxy resin in place of the inclined portion 95.

[00180], The angle between the flat portion 94 and the inclined portion 95 is preferably in the range 30?-60? and even more preferably is substantially equal to 45?.

[00181], Thanks to the features described above, provided jointly or separately in particular embodiments, it is possible to respond to the above-mentioned needs, obtaining the advantages mentioned above, and in particular:

[00182], - a miniaturized bipolar forceps is provided;

[00183], - the bipolar electrical connection, i.e. with double polarization, is made through the metal structure of the articulated terminal;

[00184], - this avoids having to provide external electrical wiring to the tips which extend through movable joints (articulated terminal);

[00185], - the articulated terminal preferably comprises an articulated cuff with two orthogonal pivot rotational joints;

[00186], - by avoiding external wiring, it is possible to avoid imposing mechanical stresses and disturbances due to the pulling action exerted by such wiring during the movement of the articulated terminal, therefore it is possible to create an articulated terminal which is extremely compact and suitable for miniaturisation and which requires low traction forces for the actuation of the moving parts (links) of the articulated terminal;

[00187], - an articulated terminal is created that is resistant and robust to the temperatures and mechanical loads of operation in active robotic surgery;

[00188], - it is therefore avoided having to compensate with dedicated control algorithms for any imbalances in the transmission of the actuation forces of the articulated terminal via tendons that could be induced by the provision of the aforementioned wiring;

[00189], - it therefore allows for fine control over the degrees of freedom of the articulated terminal by using actuation tendons;

[00190], - the sizing (thickness) of the electrically insulating body is chosen to avoid electrical arcs between the electrically conductive bodies 11 and 12 of the support link;

[00191], - the pivot pin formed by the two half-pins can be sized to avoid electrical arcs between the two half-pins as well as between a half-pin and an electrically opposed conductive body of the support link;

[00192], - the longitudinal extension shape of the tips may be chosen to minimize the risk of electric arcs between the tips in their portions outside the respective working portions;

[00193], - if necessary, it is possible to avoid having to provide electrical wiring inside the cavity of the positioning rod or spindle because the bipolar electrical connection, i.e. with double polarization, is made through the coaxial metal structure of the positioning rod or spindle itself;

[00194], - the internal cavity of the positioning rod or shaft may be occupied by the actuation tendons of the rotational joints of the articulated terminal;

[00195], - the positioning rod or shaft can be made up of two coaxial rods or shafts polarized with opposite electrical charges;

[00196], - the internal rod or shaft may be attached to a proximal link which is for example fitted into the internal cavity of the rod or shaft providing electrical conduction through its lateral surfaces;

[00197], - it is possible to create a support link having a multilayer structure with an insulating layer between two electrically conductive layers;

[00198], - electrical conduction is achieved thanks to the large contact surfaces which include the electrically conductive joint semi-pins;

[00199], - the diameter of the coaxial positioning rod or shaft can easily be made under 5 millimetres in diameter;

[00200], - the bipolar electrosurgical instrument is suitable for working in both cutting and coagulation modes, and combinations thereof, allowing vessel sealing applications for vessels with a diameter of even less than 2 millimetres;

[00201], - the bipolar electrosurgical instrument is particularly suitable for an extreme miniaturization of the articulated terminal while ensuring the electrical separation of the outgoing and return paths and satisfactory robustness under conditions of use.

[00202], Of course, the combinations of features disclosed in the appended claims form an integral and integral part of this disclosure.

[00203], To the embodiments described above, a person skilled in the art, in order to satisfy contingent and specific needs, may make numerous modifications, adaptations and replacement of elements with functionally equivalent ones, without however departing from the scope of the attached claims.

LIST OF NUMERICAL REFERENCES

Claims (20)

1. Bipolar electrosurgical instrument (1 ) comprising an articulated terminal (2) comprising: a support link (10), and a first tip (21) movable with respect to said support link (10) and having an electrically conductive body with an operating portion thereof; a second tip (22) movable with respect to said support link (10) and having an electrically conductive body with an operating portion thereof; wherein: the operating portion of the first tip (21) and the operating portion of the second tip (22) can be moved in relative approach/distance; the support link (10) has a multilayer structure consisting of a first electrically conductive body (11), a second electrically conductive body (12) and at least one electrically insulating body (20) between them; the first electrically conductive body (1 1) of the support link comprises a first support portion (13) and the first tip (21) ? mounted to said first support portion (13) in electrically conductive communication with each other, creating a first conductive path to the operating portion of the first tip; the second electrically conductive body (12) of the support link comprises a second support portion (14) and the second tip (22) is mounted to said second support portion (14) in electrically conductive communication with each other, providing a second conductive return path from the working portion of the second tip; said first forward conductive path and said second return conductive path are separated from each other in the body of the support link by said at least one electrically insulating body (20). 2. Instrument according to claim 1, wherein the first electrically conductive body (11) and the second electrically conductive body (12) of the support link (10) are each fixed and integral with the electrically insulating body (20); and wherein, preferably, the support link (10) is devoid of its internal degrees of freedom; and/or wherein the electrically conductive bodies (1 1 , 12) are both fixed to the electrically insulating body (20) remaining electrically separated for the entire volume of the support link (10). 3. Instrument according to claim 1 or 2, wherein the electrically insulating body (20) is interposed between the first electrically conductive body (11) and the second electrically conductive body (12) along their entire extension. 4. A tool according to any of the preceding claims, wherein said first support portion (13) of the first electrically conductive body (1 1 ) of the support link and the first tip (21) are constrained to rotate about an axis of rotation, and wherein said second support portion (14) of the second electrically conductive body (12) of the support link and the second tip (22) are constrained to rotate around their rotation axis, which may be parallel or aligned to said rotation axis, thus defining a distal rotational joint (DJ) of the articulated terminal (2) having said multilayer structure formed by the two electrically conductive bodies and the electrically insulating body between them. 5. Instrument according to claim 4, wherein the first support portion (13) and the second support portion (14) each comprise at least one prong made of electrically conductive material, and preferably each comprise two prongs made of electrically conductive material. 6. Instrument according to claim 4 or 5, wherein the first electrically conductive body (1 1) of the support link (10) comprises a first proximal support portion (15), and wherein the second electrically conductive body (12) of the support link comprises a second proximal support portion (16), said first proximal support portion and said second proximal support portion cooperating to define a proximal rotational joint (PJ) of the articulated terminal (3) having said multilayer structure formed by the two electrically conductive bodies and the electrically insulating body between them. 7. An instrument according to claim 6, wherein the proximal rotational joint (PJ) has a proximal rotation axis (P-P) that is orthogonal to said rotation axis, realizing the multilayer structure formed by the two electrically conductive bodies and the electrically insulating body between them in two orthogonal directions. 8. An instrument according to any of claims 4 to 7, wherein said at least one rotational joint is a pivot rotational joint comprising a pivot pin assembly (30) comprising a first electrically conductive half-pin (31) in electrically conductive communication with the first electrically conductive body (11) and with the first tip (21), and a second electrically conductive semi-pin (32) in electrically conductive communication with the second electrically conductive body (12) and with the second tip (22); between the first semi-pin (31) and the second semi-pin (32) there is an electrically insulating element (33), such as a cavity, air, a glass sphere; and wherein, preferably, said first semi-pin (31) and said second semi-pin (32) are separate and disjoined from each other. 9. Instrument according to any of the preceding claims, wherein each rotational joint of said two rotational joints (PJ, DJ) is actuated by one or more actuation tendons, preferably made of electrically non-conductive material such as woven polymer fibers. 10. An instrument according to any preceding claim, further comprising a positioning rod (3) comprising two coaxially arranged electrically conductive rigid bodies, e.g. two steel cylinders, itself forming a section of the two distinct conductive outward and return paths; and wherein, preferably, the support link (10) is articulated to the positioning rod (3) at said proximal rotational joint (PJ). 11. A tool according to any of the preceding claims, wherein the two electrically conductive bodies (1 1 , 12) are made by wire EDM using two mutually orthogonal forming cuts substantially identical to each other, resulting in two electrically conductive bodies substantially identical to each other; and wherein, preferably, said two electrically conductive bodies (1 1 , 12) are manufactured as separate pieces and subsequently assembled to the electrically insulating body (20); and wherein, preferably, the electrically insulating body is made in a single piece, for example by molding; and/or in which each electrically conductive body (11, 12) comprises a distal arm (57, 58) that grips a distal margin (54) of the electrically insulating body (20). 12. An instrument according to any preceding claim, wherein the electrically insulating body (20) comprises a plate-like portion (19) extending between the tips (21, 22) of the articulated terminal and a proximal support portion (29); and/or wherein the electrically conductive bodies (1 1 , 12) each comprise at least two sliding surfaces (48, 50) for tendons actuating the respective tips (21 , 22); said sliding surfaces (48, 50) are all convex ruled surfaces with parallel rectilinear generators, in which the parallel generators of a sliding surface (48 or 50) are orthogonal to the parallel generators of the other sliding surface (50 or 48) of said two; and in which, preferably, the parallel generatrices of one sliding surface (48) are parallel to the rotation axis of a proximal rotational joint (PJ) and the parallel generatrices of the other sliding surface (50) are parallel to the rotation axis of a distal rotational joint (DJ); and/or where the electrically insulating body (20) is made of ceramic material, for example by powder sintering; and/or the electrically insulating body (20) is made of polymeric material, for example by moulding; and/or in which the electrically insulating body comprises at least two sliding surfaces (48, 50) for actuation tendons and wherein said sliding surfaces (48, 50) are all convex ruled surfaces with parallel rectilinear generators, wherein the parallel generators of one sliding surface (48 or 50) are orthogonal to the sliding surfaces of the other sliding surface (50 or 48). 13. A tool according to any of the preceding claims, wherein the support link (10) is made by wire EDM with two mutually orthogonal forming cuts (CUT1, CUT2); and wherein, the electrically insulating body is bonded to the electrically conductive bodies in the form of an adhesive resin prior to performing any forming cuts, resulting in a multi-layer composite workpiece (90); and wherein, preferably, the electrically insulating body comprises an inclined portion which is neither parallel to the axis of rotation of the proximal rotational joint (PJ) nor to the axis of rotation of the distal rotational joint (DJ); and wherein, preferably, said inclined portion is located in proximity to or in correspondence with the proximal rotational joint (PJ). 14. Robotic system (100) for medical or surgical teleoperation comprising at least one bipolar electrosurgical instrument (1 ) according to any of the preceding claims. 15. A method of manufacturing by wire EDM a support link (10) of an electrosurgical instrument comprising the following steps of: -providing a composite workpiece (90) comprising a first electrically conductive body, a second electrically conductive body and a cavity therebetween, and displacing electrically insulating epoxy resin in the cavity; - mounting the composite workpiece to a wire EDM machine (99) comprising a cutting wire (98); - use the cutting wire (98) to make a first through-cut for shaping on the composite material workpiece, creating a through-hole for a pivot pin. 16. A method according to claim 15, comprising the further steps of: - rotating the composite workpiece relative to the cutting wire; - make a second through-forming cut on the same composite workpiece, creating a second through-hole for a second pivot pin; and/or in which the cavity comprises a substantially flat portion and a substantially inclined portion. 17. Bipolar electrosurgical instrument (1) comprising an articulated terminal (2) comprising: a support link (10), and two tips (21, 22) comprising an electrically conductive body, said two tips being articulated to the support link (10) and movable in relative approach/distance; in which: the support link (10) comprises two support portions (13, 14) which mount the two tips, respectively; the two tips are arranged side by side forming a pivot rotational joint (DJ) comprising a pin assembly (30) comprising a first semi-pin (31) which constrains the first tip (21) to rotate with respect to the first support portion (13) of the support link, a second semi-pin (32) which constrains the second tip (22) to rotate with respect to the second support portion (14) of the support link, and wherein an electrically insulating barrier (33) is provided between the first half-pin (31) and the second half-pin (32); for example, the electrically insulating barrier (33) comprises at least one of: an air gap, a glass sphere, a coating pattern. 18. Bipolar electrosurgical instrument (1) comprising: a positioning rod (3) having a distal portion; an articulated terminal (2) connected to the distal portion of the rod, comprising two tips (21, 22) comprising an electrically conductive body, said two tips being articulated with respect to the distal portion of the positioning rod and movable in relative approach/distance; in which: said two tips (21, 22) are intended to be polarized with different electric charges; the positioning rod (3) comprises two electrically conductive bodies arranged coaxially to form two distinct conductive paths, each conductive path of said two distinct conductive paths of the positioning rod (3) being in electrically conductive communication with a tip (21 or 22) of said two tips. 19. An electrical isolation assembly for separating two conductive paths of a hinged terminal (2) of a bipolar electrosurgical instrument (1 ), said hinged terminal defining at least two pivotal rotational joints (PJ, DJ), each pivotal rotational joint comprising a pivot assembly (30) comprising two electrically conductive half-pins (31 , 32); said electrical isolation assembly comprising: an electrically insulating body (20) which defines, in a single piece, two orthogonal pin joints (PJ. DJ) of said at least two pin rotational joints; an electrically insulating element (33) placed between said two semi-pins. 20. Method of assembling a support link (10) of an electrosurgical instrument comprising the following steps: - provide two electrically conductive bodies (1 1 , 12) each having a flat surface (65, 66) and an electrically insulating body (20) having two opposite flat surfaces (61 , 62); - sliding the electrically insulating body (20) relative to a first electrically conductive body (1 1) so that a flat surface (61 ) of the electrically insulating body slides on a flat surface of the first electrically conductive body; - slide the flat surface of the second electrically conductive body over the opposite flat surface of the electrically insulating body.