Bipolar electrosurgical instrument for medical-surgical teleoperation and method of manufacture
Patent Information
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- MEDICAL MICROINSTRUMENTS INC
- Filing Date
- 2024-07-22
- Publication Date
- 2026-06-17
AI Technical Summary
Existing bipolar electrosurgical instruments are unsuitable for extreme miniaturization due to the complexity of assembling electrically conductive and insulating components, leading to bulkiness and poor electrical insulation.
A bipolar electrosurgical instrument with an articulating end featuring a support link with a multilayered structure, comprising two electrically conductive bodies separated by an electrically insulating body, which forms distinct conductive paths for the tips, eliminating the need for external cables and allowing for compact miniaturization.
The solution enables extreme miniaturization of the articulating end while maintaining effective electrical insulation and robustness, suitable for applications in robotic surgery, and reduces the risk of electrical arcs and mechanical disturbances.
Smart Images

Figure IB2024057101_13022025_PF_FP_ABST
Abstract
Description
BIPOLAR ELECTROSURGICAL INSTRUMENT FOR MEDICAL-SURGICAL TELEOPERATION AND METHOD OF MANUFACTUREDESC RIPTION
[0001] . Field of the invention
[0002] . The present invention relates to an electrosurgical instrument.
[0003] . In particular, the present invention is directed to a bipolar electrosurgical instrument.
[0004] . The invention further relates to a robotic system for medical or surgical teleoperation comprising said instrument.
[0005] . Moreover, the present invention relates to a manufacturing method of said instrument.
[0006] . The invention further relates to an electrical insulating assembly for an electrosurgical instrument.
[0007] . Background art
[0008] . Robotic surgery apparatuses are generally known in the art and typically comprise a central robotic tower and one or more robotic arms extending from the central robotic tower. Each arm comprises a motorized positioning system (or manipulator) for moving a surgical instrument distally attachable thereto, in order to perform surgical procedures on a patient. The patient typically lies on an operating bed located in the operating room, in which sterility is ensured to avoid bacterial contamination due to non -sterile parts of the robotic apparatus.
[0009] . Generally, known surgical instruments for teleoperated robotic surgery comprise a proximal transmission interface (or "backend", according to 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 an articulated device (e.g . , a robotic cuff) at the distal end thereof with an operating terminal end (e.g . , needle holder, scissors, dilator, scalpel) .
[0010] . In the known surgical instruments havi ng an articulated cuff , it typically consists of a plurality of links moved by a plurality of tendons (or actuating cables). One or more terminal links can have a free end forming the aforementioned terminal operating end and are for example adapted to operate directly on a patient’s anatomy and / to handle a needle as well as a suture thread for performing anastomoses or other surgical therapies.
[0011] . Unlike the known surgical instruments comprising an articulated cuff , surgical instruments having an articulated device of the "snake" type are also known , i.e. , comprising a plurality of stacked vertebrae which are movable with respect to each other by means of a plurality of actuating cables or tendons.
[0012] . For example, US-10582975 and WO-2018-189721 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 thus of the operating end or end effector, in which the links forming the end-effector are made by wire electro-erosion.
[0013] . Surgical instruments of the type adapted to transmit electricity to tissues, such as electro-cautery surgical instruments for robotic surgery, are also known . Some known examples of such instruments are shown in prior art documents US-6840938, US-7824401 , US-10376331 , US-8398634, US-10716617, and US-2022-133388.
[0014] . The known electrosurgical instruments typically comprise one or more conductors for transmitting electricity from the robotic manipulator, by means of 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 materials and preferably with high thermal stability and insulators such as n on-conductive plastics (e.g . , ULTEM) or ceramics with the sole exclusion of the conductive metal ends on which the electrical conductive 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 , the risk arises of poor electrical insulation and the possibility of transferring electrical voltage to the entire articulating end or even backwards, to the proximal transmission interface ("backend"), by conduction by the actuating cables. Also for these reasons, the active articulating ends of such known electrosurgical instruments are usually quite bulky and unsuitable for miniaturization.
[0017] . To electrically insulate such articulating ends of the active electrosurgical instrument, insulating sleeves are typically fitted onto the entire end-effector, so as to form an electrically insulating barrier withrespect to the patient's tissue near or in contact with the end -effector itself .
[0018] . Particularly in the known electro-cautery applications in laparoscopy, it is very important to avoid transmitting electricity at the fulcrum point, i.e. , at the insertion point of the surgical instrument in the dedicated hole thereof, a fulcrum point which when in operating conditions represents the centre of rotation of the positioning rod or shaft with respect to the patient. For these reasons, the positioning shaft itself is made of electrically insulating material or coated with an insulating layer (e.g . , rubber) so as to avoid arcs with the abdominal inner 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 electrical conductor cables which run therein 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, which extends into the positioning rod or shaft of the surgical instrument from the transmission interface portion ("backend") to the articulated cuff. The positio ning shaft is typically made of electrically insulating material while the operating tip of the electrosurgical instrument is electrically active in metal. In such known monopolar electrosurgical instruments, the electrical circuit is closed by virtue of a return electrode (typically a plate) after having crossed a part of the patient's body.
[0021] . Otherwise, in bipolar electrosurgical instruments the two tips of the instrument are polarized with a different charge, such as to form two electrodes, one of which forms the return electrode. In this type of electrosurgical instruments, it is necessary to avoid short circuits between the various parts of the end-effector which have a different electrical charge (for example between the two tips as well as between the respective electrical conductors).
[0022] . It is also known to use electrically insulating sleeves which are fitted onto the articulated cuff in order to avoid involuntary deliveries of electricity from areas other than the termination (both mono - and bipolar instruments).
[0023] . The known solutions of bipolar electrosurgical instruments areunsuitable for an extreme miniaturization at the level of the articulating end due to the presence of various components to be assembled, such as electrically conductive means for polarizing the tips (“jaws”) with opposite charge, electrical insulation means, return pulleys, articulating end articulation actuation cables.
[0024] . It is technically complicated to terminate or adhere conductive electric cables to the tip end links of a miniaturized surgical instrument.
[0025] . The rigidity and size of the conductor cables connected to the jaws or articulating end tips compromise the movement, closing / opening and gripping performance, particularly with miniaturized instruments.
[0026] . Hence, the need is felt to suggest a bipolar electrosurgical instrument which is suitable for extreme miniaturization .
[0027] . Solution
[0028] . It is an object of the present invention to obviate the drawbacks complained of with reference to the prior art and suggest a solution to the needs mentioned above.
[0029] . This and other objects are achieved by an electrosurgical instrument according to claim 1 , as well as by a robotic system according to claim 14, as well as by a manufacturing method according to claim 15, as well as by an electrosurgical instrument according to claim 17 or 18, as well as by insulating assembly according to claim 19, as well as by an assembly method according to claim 20.
[0030] . Some advantageous embodiments are the subject of the dependent claims.
[0031] . According to an aspect of the invention , a bipolar electrosurgical instrument comprises an articulating end comprising a support link, and a first tip movable with respect to said support link and having an electrically conductive body with an operating portion thereof, and a second tip which is movable with respect to said support link and having an electrically conductive body with an operating portion thereof.
[0032] . The operating portion of a tip can be a gripping and / or cutting surface and / or a free end, e.g. , a sharp free end.
[0033] . The operating portion of the first tip and the operating portion of the second tip are movable towards / away from each other. Thereby, the operating portions of the tips can be movable in opening / closing with respect to each other.
[0034] . The support link has a multilayered structure formed by a first electrically conductive body, a second electrically conductive body and at least one electrically insulating body therebetween.
[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 therebetween, making a first conductive path, for example an outward 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 therebetween , making a second conductive path, for example a return conductive path from the operating portion of the second tip.
[0037] . By virtue of the provision of the first conductive path and the second conductive path, it is possible to close the electrical circuit through the body of the bipolar surgical instrument, and in particular the articulat ing end thereof having two tips and a support link having the multilayered structure comprising an electrically insulating layer between two electrically conductive layers.
[0038] . Said first outward conductive path and said second return conductive path are distinct and separated from each other in the body of the support link by said at least one electrically insulating body.
[0039] . The support portions of the support link can each comprise at least one prong , and preferably two prongs, made of electrically conduct ive material.
[0040] . Preferably, the support link lacks the internal degrees of freedom thereof.
[0041] . The respective axes of rotation of the tips are preferably aligned with each other. In accordance with an embodiment, the axes of rotation of the tips are parallel to each other and spaced a certain distance apart.
[0042] . The articulating end can comprise other degrees of freedom and the support link itself can be articulated with respect to the positioning shaft or rod of the bipolar electrosurgical instrument, while maintai ning electrical insulation between the electrically conductive bodies thereof. In accordance with an embodiment, the first electrically conductive body of the support linkcomprises a first proximal support portion, and in which 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 end having said multilayered 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 which is orthogonal to said rotation axis articulating the tips to the support link, thus defining a multilayered structure formed by the two electrically conductive bodies and the electrically insulating body therebetween in two orthogonal directions, seamlessly.
[0044] . The manufacturing of the support link can occur by wire electrodischarge of a workpiece made of a material having a multilayered structure.
[0045] . The manufacturing of the support link can occur by assembly of separate pieces, in which , for example, the electrically insulating body is made by moulding and the electrically conductive bodies are made by wire electrodischarge.
[0046] . The manufacturing by wire electrodischarge allows making sliding surfaces for the actuation tendons for actuating at least one of the tips of the articulating end. Therefore, in accordance with an embodiment, the electrically conductive bodies each comprise at least two sliding surfaces for actuation tendons of the respective tips; said sliding surfaces are all convex ruled surfaces with parallel generators, in which the parallel generators of one sliding surface are orthogonal to the sliding surfaces of the other sliding surface of said two. Preferably, the parallel generators of one sliding surface are parallel to the rotation axis of a proximal rotational joint and the parallel generators of the other sliding s urface are parallel to the rotation axis of a distal rotational joint of the articulating end of the bipolar electrosurgical instrument.
[0047] . The electrically insulating body of the support link can comprise a plate-like portion extending between the tips of the articulating end and a proximal support portion. In accordance with an embodiment, the electrically insulating body and in particular the proximal support portion thereof, comprises at least two sliding surfaces (for actuation tendons and in whichsaid sliding surfaces are all convex ruled surfaces with parallel generators, in which the parallel generators of one sliding surface are orthogonal to the sliding surfaces of the other sliding surface.
[0048] . In accordance with an embodiment, in which the two electri cally conductive bodies of the support link are made by wire electrodischarge using two mutually orthogonal shaping cuts substantially identical to each other, resulting in two electrically conductive bodies substantially identical to each other; and in wh ich, preferably, said two electrically conductive bodies are manufactured as separate pieces and then assembled to the electrically insulating body.
[0049] . According to an aspect of the invention , there can be provided a method for assembling a support link of an electrosurgical instrument comprising the steps of providing two electrically conductive bodies each having a flat surface and an electrically insulating body having two opposite flat surfaces, and sliding the electrically insulating body with respect to a first electrically conductive body so that a flat surface of the electrically insulating body slides over a flat surface of the first electrically conductive body; and sliding the flat surface of the second electrically conductive body over the opposite flat surface of the electrically insulating body. The electrically conductive bodies are preferably made by wire electrodischarge. The respective flat portions of the electrically conductive bodies are preferably formed by a prong of the support portion th ereof .
[0050] . According to an aspect of the invention, the support link comprises two support portions receiving the two tips, respectively; the two tips are arranged aligned forming a rotational pin joint comprising a pin assembly comprising a first electrically conductive half-pin in electrically conductive communication with the first electrically conductive body and with the first tip, and a second electrically conductive half -pin in electrically conductive communication with the second electrically conductive body and with the second tip, and an electrically insulating element is provided between the first half-pin and the second half-pin , such as a gap, air, a sphere of glass. The term "half -pin" is not necessarily intended to indicate a pin portion corresponding to half of the pin, for example half of the longitudinal development thereof .
[0051] . In accordance with an embodiment, said first half -pin and said second half-pin are made separate from each other.
[0052] . In accordance with an embodiment, said first half -pin and said second half-pin are separated portions of the same component (pin) . In accordance with an embodiment, the articulating pin comprises a coating having a first electrically conductive portion, a second electrically conductive portion, and a third electrically insulating portion arranged longitudinally therebetween .
[0053] . According to an aspect of the invention , the positioning rod or shaft comprises two rigid electrically conductive bodies arranged coaxially, thus autonomously forming a stretch of the two disti nct conductive outward and return paths. For example, the two rigid coaxial bodies can 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 articulating end 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 towards / away from each other; in which said two tips are intended to be polarized with different electrical charge; the positioning rod comprises two electrically conductive bodies arranged coaxial with each other forming two distinct conductive paths, each conductive path of said two distin ct conductive paths of the positioning rod being in electrical conductive communication with a tip.
[0055] . The positioning rod can be associated with an articulating end as previously described, making said two distinct conductive outward and return paths of the bipolar electrosurgical instrument through the body of the positioning rod and the body of the articulating end.
[0056] . According to an aspect of the invention, a manufacturing method by wire electrodischarge of a support link of an electrosurgical instrument comprising the following steps: (i) providing a composite workpiece comprising a first electrically conductive body, a second electrically conductive body and a cavity therebetween, and arranging electrically insulating epoxy resin in the cavity; (ii) mountin g the composite workpiece to a wire electrodischarge machine comprising a cut wire; (iii) making a first shaping through cut on the workpiece made of composite material with the cut wire, making a through seat for an articulating pin .
[0057] . The method can further comprise: rotating the compositeworkpiece with respect to the cut wire; and making a second shaping through cut on the same composite workpiece by making a second through seat for a second articulating pin.
[0058] . For example, the support link is made by wire electrodischarge with two mutually orthogonal shaping cuts, and the electrically insulating body is fixed to the electrically conductive bodies in the form of adhesive resin before executing any shaping cuts, making a composite workpiece. Preferably, the electrically insulating body comprises an inclined development portion which is not parallel to either the rotation axis of the proximal rotational joint or the rotation axis of the distal rotational joint, and for example said inclined development portion is located near or at the proximal rotational joint.
[0059] . According to an aspect of the invention, an electrical insulating assembly is provided for separating two conductive paths of an articulating end of a bipolar electrosurgical instrument. The articulating end is preferably a miniaturized articulating end, suitable for microsurgery. Said articulating end defining at least two rotational pin joints, each rotational pin joint comprising a pin assembly comprising two electrically conductive half -pins, said electrical insulating assembly comprising an electrically insulating body defining , in a single piece, two orthogonal pin joints of said at least two rotational pin joints, and an electrically insulating element interposed between said two half-pins. The electrically insulating element and the two conductive half-pins can belong to the same pin component, for example in the form of a selective insulating / conductive coating of the longitudinal body of the articulating pin .
[0060] . Brief description of the drawings
[0061] . 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 “an” embodiment in this disclosure do not necessarily refer to the same embodiment and are to be understood as at least one. Moreover, for reasons of conciseness and reduction of the total number of figures, a certain figure may be used to illustrate the features of more than one embodiment, and not all the elements of the figure may be necessary for a certain embodiment.
[0062] . Figure 1 A is an operating diagram of a bipolar electrosurgical instrument, according to an embodiment.
[0063] . Figure 1 B is an axonometric view of a robotic system for medical or surgical teleoperation .
[0064] . Figure 2 A is an axonometric view of a bipolar electrosurgical instrument, according to an embodiment.
[0065] . Figure 2 B shows the detail indicated by the circle B in figure 2 A.
[0066] . Figure 3 A is an axonometric view of the articulating end of a bipolar electrosurgical instrument, according to an embodiment, in which some parts are omitted for clarity.
[0067] . Figures 3 B and 3 C are vertical elevation views obtained according to the points of view indicated by the arrows B and C, respectively, in figure 3 A.
[0068] . Figure 3 D is a section view taken according to the cutting plane indicated by the arrows D-D in figure 3 C.
[0069] . Figure 3 E is a section view taken according to the cutting plane indicated by the arrows E-E in figure 3 B.
[0070] . Figure 4 A is an axonometric view of the articulating end of a bipolar electrosurgical instrument, according to an embodiment, in which some parts are omitted for clarity.
[0071] . Figures 4 B and 4 C are axonometric section views of the articulating end in figure 4 A.
[0072] . Figure 5 A shows a vertical elevation view of the articulating end of a bipolar electrosurgical instrument, according to an embodiment, in which some parts are omitted for clarity.
[0073] . Figure 5 B is a section view taken according to the cutting plane indicated by the arrows B-B in figure 5 A.
[0074] . Figure 5 C is a vertical elevation view obtained according to the point of view indicated by the arrow C in figure 3 A.
[0075] . Figure 5 D is a section view taken according to the cutting plane indicated by the arrows D-D in figure 5 C.
[0076] . Figure 6 A is an axonometric view of a segment of the positioning rod or shaft, according to an embodiment, in which some parts are drawn in phantom for clarity.
[0077] . Figure 6 B is a longitudinal section view of a positioning rod or shaft, according to an embodiment.
[0078] . Figure 6 C diagrammatically shows a positioning rod or shaft, according to an embodiment.
[0079] . Figure 6 D is an axonometric view of a proximal link, according to an embodiment.
[0080] . Figure 7 A is an axonometric view of a support link, according to an embodiment.
[0081] . Figure 7 B is an axonometric view with separate parts of the support link in figure 7 A.
[0082] . Figure 8 A is a vertical elevation view of a support link, according to an embodiment.
[0083] . Figure 8 B is a vertical elevation view according to the point of view indicated by the arrow B in figure 8 A.
[0084] . Figure 8 C is an axonometric view with separate parts of the support link in figure 8 A.
[0085] . Figure 9 A is an axonometric view with separate parts of some electrically conductive portions of a support link, according to an embodiment.
[0086] . Figure 9 B is a vertical elevation view of an electrically conductive body of the support link in figure 9 A.
[0087] . Figure 9 C is a vertical elevation view obtained according to the point of view indicated by the arrow C in figure 9 B.
[0088] . Figure 1 0 is an axonometric view of an electrically insulating body of a support link, according to an embodiment.
[0089] . Figure 1 1 is an axonometric view of a tip or tip link, according to an embodiment.
[0090] . Figure 1 2 A is a section view of a distal rotational joint with an articulating pin assembly, according to an embodiment.
[0091] . Figure 1 2 B is a section view of a proximal rotational joint with an articulating pin assembly, according to an embodiment.
[0092] . Figure 13 is a section view of a distal rotation al joint with an articulating pin assembly, according to an embodiment.
[0093] . Figure 14 A is an axonometric view of an articulating end of a bipolar electrosurgical instrument, according to an embodiment.
[0094] . Figure 14 B is a vertical elevation view of the articulating end in figure 14 A obtained according to the point of view indicated by the arrow B in figure 14 A.
[0095] . Figure 14 C is a view according to the point of view indicated by the arrow C in figure 14 B.
[0096] . Figure 14 D is a cross-section view taken according to the cutting plane indicated by the arrows D-D in figure 14 C.
[0097] . Figure 14 E is a longitudinal section view taken according to the cutting plane indicated with the arrows E-E in figure 14 C.
[0098] . Figure 14 F is a cross-section view taken according to the cutting plane indicated by the arrows F-F in figure 14 C.
[0099] . Figure 15 A is a view with separate parts of a workpiece, according to an embodiment.
[0100] . Figure 15 B is a plan view of the workpiece in figure 15 A, in which the cutting profile to be made is drawn.
[0101] . Figure 1 5 C is a plan view obtained according to the point of view indicated by the arrow C in figure 1 5 B.
[0102] . Figure 16 A shows a support link, according to an embodiment, obtainable from the workpiece in figure 1 5B.
[0103] . Figure 16b shows a support link, according to an embodi ment.
[0104] . Figure 1 7 diagrammatically shows a wire electrodischarge machine with a cut wire, according to an embodiment.
[0105] . Figure 1 8 A is a diagrammatic section view of an articulating end of a bipolar electrosurgical instrument, according to an embodiment.
[0106] . Figure 1 8 B is a diagrammatic section view of an articulating end of a bipolar electrosurgical instrument, according to an embodiment.
[0107] . Figure 1 9 is an axonometric view of a support link of an articulating end of a bipolar electrosurgical instrument, accord ing to an embodiment.
[0108] . Figure 20 is a diagrammatic section view of an articulating pin , according to an embodiment.
[0109] . Detailed description of some embodimentsReference throughout this description to "an embodiment" means that a particular feature, structure or function described in relation to the embodiment is included in at least one embodiment of the present invention. Therefore, the formulation “in an embodiment” in various parts of thisdescription do not necessarily all refer to the same embodiment. Mo reover, particular features, structures or functions such as those shown in different drawings can be combined in any suitable manner in one or more embodiments.[001 10]. In accordance with a general embodiment, a bipolar electrosurgical instrument 1 (or instrument 1 ) is provided.[001 11 ]. The bipolar electrosurgical instrument 1 is preferably suitable for a robotic medical or surgical teleoperation system 1 00.[001 12]. The bipolar electrosurgical instrument 1 comprises an articulating end 2. Preferably, the bipolar electrosurgical i nstrument 1 comprises a positioning rod or shaft 3 and the articulating end 2 connected to a distal portion 34 of the positioning rod or shaft. The bipolar electrosurgical instrument 1 further comprises, preferably, a proximal transmission interface portion 4 ("backend") for operative connection with a robotic manipulator 5 of the robotic system 100 for medical or surgical teleoperation. The proximal transmission interface portion 4 of the instrument 1 can comprise a connector 6 for receiving a bipolar cabl e connected at the other end to a generator 17 for electrosurgery. The generator 17 for electrosurgery is preferably in turn connected to a foot switch 1 8 which is arranged near or at the master control station 9 of the robotic system 1 00 for medical or su rgical teleoperation. The patient 8 lies on a bed 7 or operating table 7 which can be placed near the master control station 9. The bipolar connector 6 preferably comprises two separate conductive paths which can be separated by an electrically insulating layer interposed therebetween.[001 13]. The articulating end 2 of the instrument comprises a support link 1 0 and two tips 21 , 22 (or tip link, or jaws) articulated to the support link 10 and movable towards / away therefrom (for example in opening / closing). Therefore, the articulating end 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 / distancing .[001 14]. 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, separated, through the articulating end 2. For example, the first tip 21 is polarized with positive electrical chargeand the second tip 22 is polarized with negative electrical charge. The respective conductive paths extend through the articulating end 2 and preferably also through the positioning rod or shaft 3.[001 15]. Advantageously, said support link 1 0 comprises a multilayered structure comprising two electrically conductive bodies 1 1 , 1 2 and at least one electrically insulating body 20 interposed therebetween . Thereby, the two electrically conductive bodies 1 1 , 12 comprise a first el ectrically conductive body 1 1 and a second electrically conductive body 1 2 adapted to be polarized with a different electrical charge from each other, for example opposite, because they are separated by the electrically insulating body 20 therebetween. The electrically insulating body 20 is made of ceramic material, for example.[001 16]. With further advantage, each electrically conductive body 1 1 , 12 of the support link 1 0 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 1 1 of the support link 1 0 comprises a first support portion 13 ("clevis"), for example comprising two prongs, in which the first tip 21 is mounted to the first support portion 13 of the first electrically conductive body 1 1 , and in which the second electrically conductive body 12 of the support link 1 0 comprises a second support portion 14 ("clevis") , for example comprising two prongs, in which the second tip 22 is mounted to the second support portion 14 of the second electrically conductive body 1 2.[001 17]. By virtue of such a support link 10 comprising two electrically conductive bodies 1 1 , 1 2 separated from each other by an electrically insulating body 20, in which each electrically conductive body 1 1 , 12 is in electrical conductive communication with a respective tip 21 , 22 of said two tips of the articulating end 2, it is possible to make two separate conductive paths in the articulating end 2.[001 18]. Simultaneously, the need to provide conductive cables (such as electrical wires) embedded or incorporated inside the body of the support link is avoided, because the structure of the support link itself forms said two separate and disjoined conductive paths.[001 19]. It is thus possible to electrically activate the two tips 21 , 22 of the bipolar instrument 1 by electrically activating the two electrically conductive bodies 1 1 , 12 of the support link 10. For example, to this endconductive cables can be provided, terminated on said two electrically conductive bodies, respectively. Where the two separate conductive paths are also provided in the positioning rod or shaft 3, it is possible to electrically activate the two tips 21 , 22 of the bipolar instrument 1 by means of , for example, conductor cables terminated on the positioning rod or shaft 3.
[0120] . In accordance with a preferred embodiment, said support link 10 lacks internal degrees of freedom . In other words, the two electrically conductive bodies 1 1 , 1 2 are both fixed to the electrically insulating body 20 interposed therebetween, while remaining separate for the entire volume of the support link 1 0. The fastening of the electrically conductive bodies 1 1 , 1 2 to the electrically insulating body 20 can occur in various manners and for example can occur by gluing and / or welding . In accordance with an embodiment, the fastening occurs by interlocking . In accordance with an embodiment, the fastening occurs by virtue of the provision of the articulating pins in conjunction with gluing .
[0121] . Preferably, each tip 21 , 22 comprises an operating portion 23, 24 thereof , a free end 25 and an attachment root 27, 28, in which each attachment root 27, 28 is articulated to the support link 10 (for example to the respective support portion 13 or 14) forming an electrically cond uctive 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 1 1 or 1 2 and in direct and intimate contact therewith .
[0122] . The electrically insulating body 20 can have a substantially plate-like portion 19.
[0123] . Preferably, said electrically insulating body 20 is made as a single piece of ceramic material. The body of insulating materia l 20 can be formed by a plurality of layers which can for example be of different materials and which are preferably all electrically insulating .
[0124] . The electrically insulating body 20 can be made of polymer material.
[0125] . A rotational joint DJ can be provided between the support link 10 and at least one of the two tips 21 , 22, so 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(yaw axis Y-Y). Preferably, both tips 21 , 22 are constrained to rotate relative to the support link 10 about the same common axis (yaw axis or yaw Y-Y) . 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 in which the articulating pin extends along said common rotation axis (for example yaw axis or yaw Y-Y).
[0126] . In accordance with an embodiment, as shown for example in figure 19, the distal rotational joint DJ can comprise rotation axes Y1 , Y2 for the tips which are parallel to each other although not aligned.
[0127] . The articulating pin is preferably an articulating pin assembly 30 comprising at least two half -pins 31 , 32 disjoined and separated from each other. The two half-pins 31 , 32 are preferably arranged aligned with each other, i.e. , in axis. The articulating pin 30, as well as each of the half pins 31 , 32 thereof , can be made of electrically conductive material, such as surgical steel. For example, the two half -pins 31 , 32 of the articulating pin assembly 30 and the electrically conductive bodies 1 1 , 12 of the support link 1 0 are made of the same electrically conductive material.
[0128] . Air can be interposed between the two half -pins 31 , 32, i.e. , there can be provided a gap 33. A sphere 33 of electrically insulating material can be interposed between the two half -pins 31 , 32, for example a glass sphere having a diameter in the range 0.2-0.5 mm. An element 33 made of electrically insulating material, such as a drop of paint, can be interposed between the two half-pins 31 , 32. For example, at least one half pin 31 , 32 can comprise a painted end portion, thereby forming the electrically insulating element 33.
[0129] . In accordance with an embodiment, as shown for example in figure 20, the conductive half-pins 31 , 32 and the element in insulating material 33 can be made by means of selective coating of a single articulating pin . For example, an articulating pin can be made of steel and comprise a first electrically insulating coating and a second electrically conductive coating over the insulating coating , in which a longitudinally median portion of the pin lacks the conductive coating . The coating pattern thus defines the insulating element 33 and the conductive elements 31 , 32 (half-pins).
[0130] . The element of interposed insulating material is preferably in contact with the element of insulating material 20 of the support link 1 0, soas to form a continuity of electrical insulation with said body of insulating material 20, and in particular with the plate-like portion 19 thereof . The element of insulating material 33 between the two half -pins 31 , 32 of the articulating pin assembly 30 can be formed by a layer of the insulating body 20. For example, the holes of the electrically insulating body 20 are blind holes for receiving the articulating half -pins 31 , 32.
[0131] . In accordance with an embodiment, two opposite articulating half-pins (not shown) each extend from the electrically insulating body 20 forming a rotational pin joint thereof with the respective tip 21 , 22. The two opposite half-pins can be made of electrically insulating material, for example in a single piece with the insulating body 20, or of electrically conductive material, for example fastened to the insulating body 20.
[0132] . In accordance with a preferred embodiment, the electrically insulating body 20 of the support link 1 0 extends between the tips 21 , 22. In other words, 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 an 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 which is aligned (for example 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 (for example, each comprising two prongs) of the respective electrically conductive bodies 1 1 , 1 2. An articulating pin assembly 30 is inserted in said aligned through holes defining a distal rotational joint DJ of the support l ink 10.
[0133] . Proximally, the support link 1 0 can be rigidly fastened to the distal portion 34 of the positioning rod or shaft 3 of the instrument 1 .
[0134] . Alternatively, there can be provided at least one proximal joint PJ for articulating the support link 1 0 with respect to the distal portion 34 of the positioning rod or shaft 3.
[0135] . In accordance with a preferred embodiment, the support link 1 0 defines two orthogonal joints comprising a proximal joint PJ and a distal joint DJ, for example a pitch joint P-P and a yaw joint Y-Y. Preferably, each rotational joint PJ, DJ is a rotational pin joint. In accordance with an embodiment, each rotational joint PJ, DJ is defined by two opposite electrically conductive support portions 13, 14, 1 5, 1 6 and an electrically insulating portion 19, 29 therebetween .
[0136] . In accordance with an embodiment, the proximal joint PJ makes the pitch joint of the articulating end 2. To define such a proximal pitch joint, the support link 10 can comprise two electrically conductive proximal support portions 15, 16 belonging to the respective electrically conductive bodies 1 1 , 1 2, and an insulating support portion 29 therebetween belonging to said electrically insulating body 20. Preferably, the proximal support portions 15, 16 of the respective electrically conductive bodies 1 1 , 12 and the insulating support portion 29 all comprise a through hole and said through holes are all aligned, e.g . , coaxial) to receive an articulating pin assembly 30. Preferably, the proximal support portions 15, 1 6 of the respective electrically conductive bodies 1 1 , 12 and the insulating support portion 29 all have substantially the same curved and convex profile (in a plane orthogonal to the pitch rotation axis P-P) .
[0137] . In accordance with an embodiment, the proximal joint PJ for articulating the support link 10 with respect to the positioning rod or shaft 3 is formed by a distal portion 34 of the positioning rod or shaft itself. Preferably, the distal portion 34 of the positioning rod or shaft 3 comprises a prong or ear which forms a support, locating the pitch axis P-P. Said distal portion 34 of the rod preferably comprises a through hole which is arranged coaxial with the through holes of the proximal support portions 15, 16, 29 of the electrically conductive 1 1 , 1 2 and insulating 20 bodies, respectively, of the support link 1 0. An articulating pin assembly 30 is preferably inserted in said coaxial through holes, thereby defining the pitch rotation axis P -P.
[0138] . 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-negative, by providing two distinct conductive paths which both extend, separated, through the articulating end 2. In accordance with an embodiment, said two distinct conductive paths also extend for at least one portion of the positioning rod or shaft 3, and in particular for at least the distal portion 34 of the rod.
[0139] . To this end, said distal portion of the rod 34 can comprise a single prong while the other opposite prong can be made by a proximal link 35 fastened to the positioning rod 3.
[0140] . 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 an embodiment, the proximal link 35 comprises a single support prong for the pitch axis P-P comprising a through hole for receiving the articulating 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 articulating pin.
[0141] . The distal portion of the positioning rod 3 can comprise an internally hollow body and the proximal link 35 can be mounted (e.g . , fastened with one or more fastening pi ns 38 or keyed) in the inner cavity 39 of the distal portion 34 of the rod. The positioning rod in turn can comprise two coaxial conductive elements 41 , 42 (for example blanket 41 and core 42) polarized with opposite electric charge, with an electrically i nsulating element 36 of generally circular extension , such as a ring 36 or a sleeve 36, interposed therebetween to make said two distinct conductive paths. The annular insulating element 36 can be formed by a centring bushing. The inner cavity 39 which receives the proximal link 35 can obtain the electrical conduction through the curved side walls 26 of the support link 35.
[0142] . For example, only the core 42 carries out a structural function , i.e. , it is fastened to the proximal backend of the instrument, while the blanket 41 of the rod 3 exclusively has an electrical function , or vice versa.
[0143] . In accordance with an embodiment, the proximal link 35 is mounted coaxial to the distal portion 34 of the positioning rod 3, causing the single prong of the distal portion 34 to be at a greater radial height with respect to the single prong of the coaxial proximal link 35. In other words, in this embodiment the prongs defining the support to the pitch proximal joint PJ are asymmetrical, i.e. , they are not equidistant from the longitudinal extension axis R-R of the positioning rod or shaft 3. This can cause the respective electrically conductive body 1 1 or 1 2 of the support link 1 0 to have a seat 37 for receiving 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 an outermost radial level , is not received in any seat.
[0144] . The positioning rod or shaft 3 of the bipolar electrosurgical instrument 1 can itself form the two distinct conductive paths for the tips 21 , 22 of different polarity. In accordance with an embodiment, the positioning shaft or rod 3 comprises an outer portion or blanket 41 , made of electrically conductive material, such as surgical steel, and an inner portion 42 or core 42, made of electrically conductive material, in which the outer portion orblanket 41 and the core 42 are polarized with a diff erent electrical charge from each other, and in which the outer portion or blanket 41 is in electrically conductive connection with one tip and the inner portion 42 or core is in electrically conductive connection with the other tip. As shown for example in figure 6 A-B, the outer portion or blanket 41 can form said single prong or ear of the distal portion 34 of the shaft and be in electrically conductive communication therewith while the inner portion 42 or core can be in electrically conductive communication with the single prong or ear of the proximal link 35.
[0145] . The outer 41 and inner 42 portions of the positioning rod or shaft 3 are preferably both internally hollow and can be arranged coaxial to each other and coaxial to the longitudinal extension axis R-R of the positioning rod or shaft 3. A gap 52 can be left between the outer portion 41 and the inner portion 42 and / or an element of electrically insulating material 36, such as an insulating ring or sleeve, can be interposed. For example, a plurality of rings made of insulating material can be provided, arranged along the longitudinal extension of the positioning rod or shaft 3 and interposed between the blanket 41 and the inner portion 42, while leaving a gap 52 of free space between successive longitudi nally spaced rings. The insulating ring or sleeve can be applied by casting . In accordance with an embodiment, holes or openings 43 are provided in the blanket 41 for casting material, for example glue, adapted to simultaneously form electrical insulation and mechanical seal between the blanket 41 and the inner portion 42 of the positioning rod or shaft.
[0146] . The ring of electrically insulating material 36 can be made of one or more centring bushings made of polymer material (for example: PEEK or polyether ether ketone), so as to simplify the relative positioning of the blanket 41 on the core 42 of the electrically conductive positioning rod or shaft comprising the two separate conductive paths for the bipolar electrosurgical instrument 1 .
[0147] . Holes or openings 43 can be provided in the blanket 41 at openings of the core 42 for the insertion of fastening pins 38, for example.
[0148] . The positioning rod or shaft 3 is preferably coated with a layer (e.g . , a sleeve 40) of electrically insulating material, and preferably also thermally insulating . In other words, where said blanket 41 made of electrically conductive material is provided, it can comprise a coating madeof electrically insulating material, for example silicone.
[0149] . In accordance with an embodiment, a protective cap 44 is provided to protect at least partially the articulating end 2 of the instrument 1 while exposing the two tips 21 , 22 with the free ends 25 thereof distally outside the protective cap 44. For example, the protective cap 44 comprises two distal openings 51 for individually receiving 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 articulating end 2 while maintaining an intimate adhesion therewith. The protective cap 44 can make a fluid-tight closure on the articulating end and / or on the positioning rod or shaft 3 to prevent fluids, vapours and fumes from hitting the articulating end 2 when in operating conditions. The protective cap 44 can comprise in a sing le piece a sleeve 40 covering the positioning rod or shaft 3.
[0150] . Preferably, in order to actuate the tips 21 , 22 of the articulating end 2 to open / close, as well as under 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 therein, i.e. , inside the inner portion 42 or core, until reaching the articulating end 2, and in particular a termination seat 46 provided in the body of the tip link 21 , 22 to be actuated.
[0151] . As shown for example in figures 3 A-D, to move the first tip 21 with respect to the support link 1 0 about the yaw axis Y-Y, and in particular to move the first tip 21 with respect to the suppo rt portion 13 of the first electrically conductive body 1 1 of the support link 1 0, 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 segment of the actuation tendon is wound, near the termination seat 46. The distal end of the actuation tendon 45 can comprise a knot, a boss, or other enlarged po rtion for achieving a dragging action in rotation on undercut walls of the termination seat 46.
[0152] . Said actuation tendon 45 terminated in the termination seat 46 of the first tip 21 extends through the articulating end 2, and in particular is wound around a pulley portion 48 of the support portion 15 of the first electrically conductive body 1 1 of the support link 10. When the actuationtendon 45 pulls the first tip 21 , it slides on the pulley portion 48 of the support portion 1 5 of the first electrically cond uctive body 1 1 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 generator 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 1 2 of the support link 10 can describe a reverse winding path i.e. , in an opposite winding direction on a convex ruled surface of the pulley portion 48 of the proximal support portion 16. In addition , the actuation tendon 45 also winds with sliding around a pulley portion 49 of the proximal link 35, in which this pulley portion 49 also comprises, to facilitate the sliding of the tendon, a sliding surface which is convex and ruled, formed by generator lines all parallel to the pitch rotation axis P-P. The ruled surfaces as well as the pulley portions 48, 49 lack guide channels or concave grooves for receiving the actuation tendon.
[0153] . The electrically conductive bodies 1 1 , 12 of the support link 10 can comprise other ruled sliding surfaces 50, as well as in the pulley portions 48 of the proximal support portions 1 5, 1 6 thereof . In accordance with an embodiment, the electrically conductive bodies 1 1 , 12 each comprise a ruled sliding surface 50 formed by generator lines parallel to the yaw rotation axis Y-Y. Thereby,
[0154] . The support link 10 is also preferably actuated by at least one actuation tendon thereof (two antagonistic tendons) and can comprise a termination seat 47 for receiving the action of the actuation tendon. The termination seat 47 of the support link 10 can be made by means of a through hole on the electrically insulating body 20 (through in a direction parallel to the yaw rotation axis Y-Y, for example). The electrically conductive bodies 1 1 , 1 2 are arranged so that the termination seat 47 i.e. , the through hole of the electrically insulating body 20 is accessible, in other words unobstructed, in the direction of the yaw axis Y-Y.
[0155] . The actuation tendons 45 are electrically non -conductive actuation tendons and preferably are braided polymer tendons. For example, the polymer tendons are formed from fibres made of high molecular weight polyethylene (U HMWPE) which are braided. For exam ple, the polymer tendons are made of Kevlar®. Therefore, the polymer actuation tendons are unsuitable to act as electrical conductors, avoiding creatingshort circuits between parts of the articulating end 2 polarized with opposite electrical charge. For example, the actuation tendon for the second tip 22 slides on a ruled surface of the pulley portion 49 of the proximal link 35 and slides on a pulley portion 48 of the second electrically conductive body 1 2 of the support link 1 0, avoiding placing said seco nd electrically conductive body 12 (which in turn is in electrically conductive communication with the distal portion 34 of the shaft) in electrically conductive communication with said proximal link 35.
[0156] . The provision of polymer actuation tendons in combination with the ruled and convex sliding surfaces allows an extreme miniaturization of the articulating end.
[0157] . As mentioned above, the support link 1 0 preferably lacks movable parts, i.e. , it lacks internal deg rees of freedom. The electrically insulating body 20 can be fixed to the two electrically conductive bodies 1 1 , 12 and interposed therebetween in various manners.
[0158] . In accordance with a preferred embodiment, the electrically insulating body 20 is interposed between the electrically conductive bodies 1 1 , 1 2 and in contact therewith 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 for abutting against flat positioning counter-surfaces provided on the electrically conductive bodies 1 1 , 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 away from each other, said electrically insulating body 20 comprising a proximal support portion 29 comprising two flat positioning surfaces 63, 64 thereof 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 can comprise a yaw, blind or through hole, and the proximal support portion 29 a pitch, blind or through hole. The plate-like portion 1 9 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 can extend proximally overhanging from the proximal margin 53 of the plate-like portion 1 9 of the electrically insulating body 20. The proximal 53 and distal 54 margins of theplate-like portion 19 of the electrically insulating body 20 can 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 1 9 with a generally quadrangular (e.g . , rectangular or square) or polygonal plan , creating an electrically insulating barrier between the two electrically conductive bodies 1 1 , 1 2 of the support link 10.
[0159] . Preferably, the electrically insulating body 20 further comprises at least one recess 55, 56 which is preferably placed on the distal margin 54 of the electrically insulating body 20 to receive a distal armlet or hook 57, 58 of the first or second electrically conductive body 1 1 or 12. A recess 55, 56 is preferably provided on or next 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 the flat positioning surface 61 , 62 thereof . The distal armlet 57 of the first conductive body 1 1 thus defines a seat for receiving the recess 55 of the insulating body 20 and the distal arm 58 of the second conductive body 1 2 thus defines a seat for receiving the recess 56 of the insulating body 20.
[0160] . The distal armlets 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 margin 54 of the insulating body 20 in a direction parallel to the yaw axis Y-Y. In other words, the provision of the opposite distal armlets 57, 58 allows minimizing the clearance in the direction of the yaw axis at the level of the distal margin 54 of the insulating body, contributing to keep the action of the electrically conductive tips precise, even with low actuation forces.
[0161] . 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 insulation, i.e. , to prevent a distal arm 57 of the first conductive body 1 1 from forming an electric arc with a portion of the conductive body 12 polarized with opposite charge.
[0162] . By virtue of the provision of said distal armlets 57, 58 it is possible to use articulating pin assemblies 30 having two separate and disjoined 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.
[0163] . The electrically conductive bodies 1 1 , 12 can comprise aproximal seat 59 for receiving the proximal margin 53 of the plate-like body 19 of the electrically insulating body 20 which is opposite the distal arm lets 57, 58. The proximal seat 59 cooperates to minimize the clearance in the direction of the yaw axis Y-Y.
[0164] . In accordance with an embodiment, the respective support portions 13, 14 of the electrically conductive bodies 1 1 , 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 1 9. The respective armlet 57 or 58, preferably, forms a folded segment facing the flat positioning counter-surface 65 or 66. Preferably, the support portion 13, 14 of each electrically conductive body 1 1 , 1 2 comprises two prongs defining an attachment seat 67, 68 therebetween for receiving an attachment root 27, 28 of a respective tip link 21 , 22, in which one of the two prongs comprises the positioning countersurface 65, 66 thereof, facing away with respect to the attachment seat 67, 68.
[0165] . In accordance with an embodiment, the respective proximal support portions 1 5, 1 6 of the electrically conductive bodies 1 1 , 1 2 each comprise a flat positioning counter-surface 69, 70 for abutting against a respective flat positioning surface 63, 64 of the proximal support portion 29 of the electrically insulating body 20.
[0166] . In accordance with an embodiment, as shown for example in figures 9 A-C, the two electrically conductive bodies 1 1 , 1 2 are made equal to each other. Said two electrically conductive bodies 1 1 , 12 can be made by wire electrodischarge (WEDM) on two cutting planes orthogonal to each other starting from metal workpieces, for example in surgical steel, using the same cutting profiles. This simplifies mass production while allowing an easy assembly of the conductive bodies 1 1 , 12 with the insulating body 20.
[0167] . The electrically insulating body 20 can be m ade by sintering ceramic powders. The electrically insulating body 20 can be milled to make, for example, said recesses 55, 56.
[0168] . The electrically insulating body 20 can be made by moulding (micro-moulding) polymer material.
[0169] . The proximal link 35 having a single prong can be made by moulding and milling metal material, for example surgical steel.
[0170] . The proximal rotational joint PJ defining the pitch axis P -P canthus comprise the proximal support portions 15, 16 of the conductive bodies 1 1 , 1 2, 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 articulating pin of the proximal rotational joint PJ can be an articulating pin assembly 30 comprising two half -pins 31 , 32 made of electrically conductive material which are not in electrically conductive communication with each other. It is thus possible to make a path of electrical continuity involving the proximal link 35, the respective proximal support portion 15 of the first conductive body 1 1 and the respective half -pin 31 , and a path of electrical continuity involving the distal portion 34 of the positioning rod 3, the respective proximal su pport 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 articulating pin assem bly 30. The electrically insulating portion 33 of the articulating pin assembly 30 can comprise: air and / or an insulating body, for example, a glass body, for example, a glass sphere.
[0171] . The distal rotational joint DJ defining the yaw axis Y-Y can thus comprise the support portions 13, 14 of the conductive bodies 1 1 , 1 2, and the plate-like portion 1 9 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 articulating pin of the distal rotational joint DJ can be an articulating pin assembly 30 comprising two half-pins 31 , 32 made of electrically conductive material which are not in electrically conductive communication with each other. It is thus possible to create a path of electrical continuity involving the first electrically conductive body with the support portion 13 thereof and the attachment root 27 of the first tip 21 and the first half -pin 31 , and a path of electrical continuity involving the second electrically conductive body with the support portion 14 thereof and the attachment root 28 of the second tip 22 and the second 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 articulating pin assembly 30. Proximally, said two electrically conductive paths can continue to involve for the first path the proximal support portion 1 5 of the first conductive body, the first half -pin 31and the proximal link 35, and for the second path the proximal support portion 1 6 of the second conductive body, the second half -pin 32 and the distal portion 34 of the positioning rod 3.
[0172] . When in assembled support link 1 0 condition , the seat 59 of each conductive body 1 1 , 12 forms a proximal abutment for the proximal margin 53 of the plate-like portion 1 9 of the electrically insulating body 20 and the armlets 57, 58 form distal abutments for the distal margin 54 of the plate-like portion 1 9 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 counter-surfaces 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 thereof of the proximal support portion 1 5 or 16 of the first or second conductive body 1 1 or 12. The single prong of the distal portion 34 of the positioning rod 3, having opposite charge with respect to the proximal link 35, can come into intimate contact with the proximal support portion 1 6 or 1 5 of the second or first conductive body 1 2 or 1 1 .
[0173] . According to a preferred embodiment, an electrically insulating barrier is formed along the articulating end 2 of the bipolar electrosurgical instrument 1 comprising said electrically insulating body 20, and the electrically insulating portion 33 of the articulating pin assembly 30 of the distal rotational joint DJ. Preferably, the electrically insulating barrier also comprises the electrically insulating portion 33 of the articulating 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 blanket 41 and the inner portion 42 of the positioning rod 3.
[0174] . For example, assembling the electrosurgical instrument 1 can comprise gluing the outer portion 41 and the inner portion 42 of the positioning rod 3 by casting 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. The proximal link 35 is then m ounted to the distal portion 34 of the rod and the coaxial holes for the pitch rotation axis P-P are drilled thereon . At this point, the proximal link 35 can be extracted from the positioning rod and assembled with the support link 1 0 and the tips21 , 22.
[0175] . As mentioned above, according to an embodiment, the electrically insulating body 20 is manufactured separately from the electrically conductive bodies 1 1 , 12 of the support link 10 and then the electrically insulating body 20 and the electrically conductive bodies 1 1 , 1 2 are assembled together. For example, the insulating body 20 can be manufactured by moulding and / or milling , the conductive bodies 1 1 , 1 2 can be manufactured by wire electrodischarge on two orthogonal cutting planes, and the assembly can occur by gluing and by the use of articulating pins.
[0176] . In accordance with another embodiment, the support link 10 can be made entirely by wire electrodischarge (WEDM) on two mutually orthogonal cutting planes, and in this case the workpiece can already comprise a composite multilayered structure 90 comprising an electrically insulating body 20 interposed between two electrically conductive bodies 1 1 , 12. As shown for example in figure 15a, the workpiece 90, i.e. , the workpiece to cut by wire electrodischarge (WE DM) , can be a composite workpiece 90 comprising two electrically conductive workpieces 91 , 92 (e.g . , of metal, such as steel) appropriately shaped to form a hollow seat therebetween in which an electrically insulating material 93, such as a casting of epoxy resin 93, is arranged, which acts both as an adhesive to keep the electrically conductive workpieces 91 and 92 adhered during the wire electrodischarge cutting steps, and as an electrically insulating element. Fastening means can be provided for packing the conductive workpieces 91 , 92 with the epoxy resin 93.
[0177] . The composite workpiece 90 having the multilayered structure is preferably cut with the cut wire 98 of the wire electrodischarge machine 99 on two mutually orthogonal cutting planes, making two orth ogonal shaping cuts CUT1 , CUT2 on the composite workpiece, as shown for example in figures 15 B and 15C. The wire electrodischarge shaping cuts CUT1 , CUT2 are preferably through cuts on the composite workpiece 90. The composite workpiece 90 can comprise a cylindrical mounting portion 96, adapted to be inserted into a respective hole of a wire electrodischarge tooling . The cylindrical mounting portion 96 can be employed to individually rotate the workpiece 90 between the shaping cuts CUT1 , CUT2, i.e. , there can be provided a motor which rotates the cylindrical mounting portion 96 of the composite workpiece 90.
[0178] . 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 which allows making the multilayered structure on two portions defining rotational pin joints PJ, DJ with mutually orthogonal axes. To this end, the cavity i.e. , the epoxy resin layer 93 can comprise a substantially flat portion 94, i.e. , parallel or orthogonal to the cut wire of the electrodischarge machine 99 and an inclined portion 95, i.e. , oblique which is neither parallel nor orthogonal to the cut wire 98. As shown for example in figure 14D, the inclined portion 95 of insulating material allows arranging , on the proximal rotational joint PJ of the support link 1 0, a layer of insulating material 20 which is inclined, i.e. , oblique with respect to the pitch axis P - P, thus obtaining two locally distinct and separate conductive paths in the direction of the pitch axis P-P (i.e. , thereby making the proximal support portions 1 5, 16 of the conductive bodies 1 1 , 12). Simultaneously, the provision of the flat portion 94 in a single piece with said inclined portion 95 makes the locally distinct and separate conductive paths in the direction of the yaw axis Y-Y (i.e. , thereby making the support portions 13, 14 for the respective tips 21 , 22).
[0179] . The provision of the inclined portion 95 makes the electrically insulating body 20 between the two electrically conductive bodies 1 1 , 12 of the support link 1 0 robust, or in any case more robust than the hypothesis of providing an orthogonal portion of epoxy resin instead of the inclined portion 95.
[0180] . The angle between the flat portion 94 and the inclined portion 95 is preferably in the range of 30°-60°, and even more preferably is substantially 45°.
[0181] . By virtue of the features described above, provided in mutual combination or not in particular embodiments, it is possible to meet to the aforementioned needs, thus achieving the aforementioned advantages, and in particular:
[0182] . - a miniaturized bipolar gripper is provided;
[0183] . - the bipolar electrical connection, i.e. , double polarization, is made through the metal structure of the articulating end;
[0184] . - the need to provide electrical cables outside the tips extending through movable joints (articulating end) is thus avoided;
[0185] . - the articulating end preferably comprises an articulated cuffwith two orthogonal rotational pin joints;
[0186] . - by avoiding external cables, the imposition of stresses and mechanical disturbances due to the pulling action exerted by such cables during the movement of the articulating end is avoided, thus allowing the creation of an articulating end which is highly compact and suitable for an extreme miniaturization and which requires low tensile forces for the actuation of the movable parts (links) of the articulating end;
[0187] . - an articulating end is made, which is resistant and robust to temperatures and mechanical operating loads in active robotic surgery;
[0188] . - the need to compensate for any imbalances in the transmission of the actuation forces of the articulating end with dedicated control algorithms, by means of tendons which could be induced by the provision of the aforesaid cables, is thus avoided;
[0189] . - fine control of the degrees of freedom of the articulating end is thus allowed through the use of actuation tendons;
[0190] . - the dimensioning (thickness) of the electrically insulating body is chosen to avoid electric arcs between the electrically conductive bodies 1 1 and 1 2 of the support link;
[0191] . - the articulating pin formed by the two half -pins can be dimensioned so as to avoid electric arcs between the two half -pins as well as between a half-pin and an electrically opposite conductive body of the support link;
[0192] . - the longitudinal extension shape of the tips can be chosen to minimize the risk of electric arcs between the tips in the portions thereof which are outside the respective operating portions;
[0193] . - if necessary, the need to provide electrical cables inside the cavity of the positioning rod or shaft is avoided because the bipolar electrical connection, i.e. , double polarization , is obtained through the coaxial metal structure of the positioning rod or shaft itself ;
[0194] . - the inner cavity of the positioning rod shaft can be occupied by the actuation tendons of the rotational joints of the articulating end ;
[0195] . - the positioning rod or shaft can be formed by two polarized coaxial rods or shafts with opposite electric charge;
[0196] . - the internal rod or shaft can be fastened to a proxim al link which, for example, is keyed in the inner cavity of the rod or shaft, creating electrical conduction through the side surfaces thereof ;
[0197] . - it is possible to create a support link having a multilayered structure with an insulating layer between two e lectrically conductive layers;
[0198] . - electrical conduction is achieved by virtue of the large contact surfaces which comprise the electrically conductive articulating half -pins;
[0199] . - the diameter of the coaxial positioning rod or shaft can easily be made below 5 millimetres in diameter;
[0200] . - the bipolar electrosurgical instrument is adapted to work in both cutting mode and in coagulation mode, and combinations thereof , allowing applications in vessel sealing for vessels having a diameter even less than 2 millimetres;
[0201] . - the bipolar electrosurgical instrument is particularly suitable for an extreme miniaturization of the articulating end while ensuring the electrical separation of the outward and return trips and a satisfactory robustness in use conditions.
[0202] . It is well understood that the combinations of features disclosed in the appended claims form an integral part of the present disclosure.
[0203] . In order to meet specific, contingent needs, those skilled in the art may make several changes and adaptations to the above-described embodiments and can replace elements with others which are functionally equivalent, without departing from the scope of the appended claims.LIST OF REFERENCE SIGNS
Claims
CLAIMS1. Bipolar electrosurgical instrument (1 ) comprising an articulating end (2) comprising : a support link (1 0) , and a first tip (21 ) movable with respect to said support link (1 0) and having electrically conductive body with an its own operating portion ; a second tip (22) movable with respect to said support link ( 10) and having electrically conductive body with an its own operating portion ; wherein : the operating portion of the first tip (21 ) and the operating portion of the second tip (22) are movable towards / away one another; the support link (1 0) has a multilayered structure formed by a first electrically conductive body ( 1 1 ), a second electrically conductive body (1 2) and at least one electrically insulating body (20) therebetween ; the first electrically conductive body ( 1 1 ) of the support link comprising a first support portion (13) and the first tip (21 ) is mounted to said first support portion ( 13) in communication of electrical conduction thereto, thereby realizing a f irst conductive path towards the operative portion of the first tip; the second electrically conductive body (12) of the support link comprising a second support portion (14) and the second tip (22) is mounted to said second support portion (14) in commun ication of electrical conduction thereto, thereby realizing a second conductive path from the operative portion of the second tip; said first conductive path and said second conducive path are separated from one another within the body of the support link by means of said at least one electrically insulating body (20) .
2. Instrument according to claim 1 , wherein the first electrically conductive body ( 1 1 ) and the second electrically conductive body (1 2) of the support link ( 10) are each fixed integral to the electrically insulating body (20) ; and wherein, preferably, the support link ( 10) is devoid of any internal degree of freedom ; and / or wherein the electrically conductive bodies (1 1 , 1 2) are both fixed to the electrically insulating body (20) while keepi ng separate from one another for the entire volume of the support link (1 0).
3. Instrument according to claim 1 or 2, wherein the electrically insulatingbody (20) is interposed between the first electrically conductive body (1 1 ) and the second electrically conductive body ( 1 2) for their entire extension .
4. Instrument according to any one 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 (1 2) of the support link and the second tip (22) are constrained to rotate about a their own axis of rotation , which may be parallel or aligned to said axis of rotation, thereby defining a distal rotational joint (DJ) of the articulating end (2) having said multilayered structure made of the two electrically conductive body and the electrically insulating body there between .
5. Instrument according to claim 4, wherein the first support portion (13) and the second support portion (14) comprise each at least one prong made of electrically conductive material, and preferably they comprise each a pair of 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 (1 5) , and wherein the second electrically conductive body ( 1 2) of the support link comprises a second proximal support portion (1 6) , said first proximal support portion and said second proximal support portion cooperating with each other to define a proximal rotational joint (PJ) of the articulating end (3) having said multilayered structure made of the two electrically conductive body and the electrically insulating body there between.
7. Instrument according to claim 6, wherein the proximal rotational joint (PJ) has a proximal rotation axis (P-P) that is orthogonal to said axis of rotation, thereby making the multilayered structure made of the two electrically conductive body and the electrically insulating body there between in two mutually orthogonal directions.
8. Instrument according to any one of claims 4 to 7, wherein said at least one rotational joint is a pin rotational joint comprising an articulating pin assembly (30) comprising a first electrically conductive half -pin (31 ) that is in electricconduction communication with the first electrically conductive body ( 1 1 ) and with the first tip (21 ) , and a second electrically conductive half -pin (32) that is in electric conduction communication with the second electrically conductive body (12) and with the second tip (22) ; between the first half-pin (32) and the second half-pin (32) it is provided an electrically insulating element (33), such as a gap, air, a sphere made of glass; and wherein , preferably, said first half -pin (31 ) and said second half-pin (32) are separated and disjoined from one another.
9. Instrument according to any one of the preceding claims, wherein each rotational joint of said two rotational joints (PJ, DJ) is actuated by means of one or more actuation tendons, preferably made of a non -conductive material such as braided polymer fibres.
10. Instrument according to any one of the preceding claims, further comprising a positioning shaft (3) comprising two electrically conductive rigid bodies arranged coaxially, such as two steel cylinders, thereby forming a segment of said two disjoined electrically conductive paths; and wherein, preferably, the support link ( 10) is articulated to the positioning shaft (3) in said proximal rotational joint (PJ) .11 . Instrument according to any one of the preceding claims, wherein the two electrically conductive bodies (1 1 , 1 2) are made by wire electrodischarge machining using two shaping cuts that are mutually orthogonal and substantially identical to each other, thereby resulting in two electrically conductive bodies that are substantially identical to each other; and wherein, preferably, said two electrically conductive bodies (1 1 , 12) are made as separate pieces and subsequently assembled to the electrically insulating body (20) ; and wherein, preferably, the electrically insulating body is made as a sing le piece, for example by moulding ; and / or wherein each electrically conductive body ( 1 1 , 1 2) comprises a distal armlet (57, 58) that grasps a distal margin (54) of the electrically insulating body (20).
12. Instrument according to any one of the preceding claims, wherein the electrically insulating body (20) comprises a plate-like portion (19) extending between the tips (21 , 22) of the articulating end and a proximalsupporting portion (29) ; and / or wherein the electrically conductive bodies ( 1 1 , 1 2) comprise each at least two sliding surfaces (48, 50) for the actuation tendons of the respective tips (21 , 22) ; said sliding surfaces (48, 50) are all convex ruled surfaces with straight parallel generators, wherein the parallel generators of one sliding surface (48 or 50) are orthogonal to the parallel generators of the other sliding surface (50 or 48) of said two; and wherein , preferably, the parallel generators of one sliding surface (48) are parallel to the rotational axis of a proximal rotational joint (PJ) and the parallel generators of the other sliding surface (50) are parallel to the axis of rotation of the distal rotational joint ( D J) ; and / or wherein the electrically insulating body (20) is made of ceramic material , for example by sintering of powders; and / or the electrically insulating body (20) is made of polymeric material, for example made by moulding ; and / or wherein 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 straight parallel generators, wherein the parallel generators of one sliding surface (48 or 50) are orthogonal to the parallel generators of the other sliding surface (50 or 48) .
13. Instrument according to any one of the preceding claims, wherein the support link (10) is made of wire electrodischarge with two shaping cuts (CUT1 , CUT2) that are mutually orthogonal ; and wherein, the electrically insulating body is fixed to the electrically conductive bodies while in the form of adhesive resin before executing any shaping cut, thereby making a composite multilayered workpiece (90) ; and wherein, preferably, the electrically insulating body comprises a portion with inclined development and that is not parallel neith er 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 portion with inclined development is located near or at the proximal rotational joint (PJ).
14. Robotic system (1 00) for medical or surgical teleoperation comprising at least one bipolar electrosurgical instrument ( 1 ) according to any one of the preceding claims.
15. Method of manufacturing by wire electrodischarge of 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 there between, and arranging electrically insulating epoxy res in in said cavity;- mounting the composite workpiece to a wire electrodischarge machine (99) comprising a cut wire (98) ;- executing , with the cut wire (98) , a first shaping through cut on the composite workpiece, thereby making a through seat for an arti culating pin .
16. Method according to claim 1 5, comprising the further steps of :- rotating the composite workpiece with respect to the cut wire;- executing a second shaping through cut on the same composite workpiece, thereby making a second through seat for a second articulating pin ; and / or wherein the cavity comprises a portion that is substantially flat and a portion that is substantially sloped.
17. Bipolar electrosurgical instrument ( 1 ) comprising an articulating end (2) comprising : a support link (1 0), and two tips (21 , 22) comprising electrically conductive body, said two tips being articulated to the support link (1 0) and movable away / towards each other; wherein : the support link ( 10) comprises two support portions (13, 14) respectively mounting the two tips; the two tips are arranged next to each other forming a rotational pin joint (DJ) comprising a pin assembly (30) comprising a first half -pin (31 ) constraining the first tip (21 ) to rotate with respect to a first support portion (13) of the support link, a second half-pin (32) constraining the second tip (22) to rotate with respect to a second support portion (14) of the support link, and wherein it is provided an electrically insulating barrier (33) between the first half-pin (31 ) and the second half-pin (32) ; for example, the electrically insulating barrier (33) comprises at least one of : a gap, air, a sphere made of glass, a pattern of coating.
18. Bipolar electrosurgical instrument (1 ) comprising : a positioning shaft (3) having a distal po rtion ; an articulating end (2) coupled to the distal portion of the shaft, comprisingtwo tips (21 , 22) comprising electrically conductive body, said two tips being articulated with respect to the distal portion of the positioning shaft and moveable away / towards each other; wherein : said two tips (21 , 22) are intended to be polarized with different electrical charge; the positioning shaft (3) comprises two electrically conductive bodies arranged coaxially thereby forming two distinct conductive paths, each conductive path of said two distinct conductive paths of the positioning shaft (3) being in electrical conduction communication with a tip (21 or 22) of said two tips.
19. Electrical insulating assembly for separating two conductive paths of an articulating end (2) of a bipolar electrosurgical instrument (1 ), said articulating end defining at least two rotational pin joints, each rotational pin joint comprising a pin assembly (30) comprising two half -pins (31 , 32) that are electrically conductive; said electrical insulating assembly comprises: an electrically insulating body (20) defining , in single piece, two mutually orthogonal pin joints (PJ, DJ) of said at least two rotational pin joints; an electrically insulating element (33) interposed between sai d two half-pins.
20. Method for the assemblage of a support link (1 0) of an electrosurgical instrument comprising the steps of :-providing 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) ;-making the electrically insulating body (20) to slide with respect to a first electrically conductive body (1 1 ) so that a flat surface (61 ) of the electrically insulating body slides onto a flat surface of the first electrically conductive body;- making the flat surface of the second electrically conductive body to slide onto the opposite flat surface of the electrically insulating body.