Active electrosurgical instrument and protective cap, particularly for medical-surgical teleoperation, and related robotic system

Abstract

Assembly (1) comprising an electrosurgical instrument (10) comprising a positioning shaft (13) having a distal portion (14), an articulating end (15) connected to the distal portion (14) of the shaft and comprising at least one tip (16; 17) of electrically conductive material having an elongated body forming a free end (18); a protective cap (20) fitted on the articulating end (15) of the electrosurgical instrument and comprising a body of electrically insulating material comprising a proximal opening (22) defined by a proximal opening edge (23) of the cap body, at least one distal opening (24; 25) defined by at least one distal opening edge (26; 27) of the cap; the at least one tip (16; 17) of the articulating end (15) is movable with respect to the positioning shaft (13) and is actuated by at least one actuation tendon (11); the at least one tip (16; 17) of the articulating end (15) comprises an actuation interface portion (19) for receiving the actuation action of said at least one actuation tendon (11); said actuation interface port ion (19) of the at least one tip (16; 17) is inside the protective cap (20); said at least one actuation tendon (11) is made at least partially of polymeric material; the body of the protective cap (20) is made of thermally insulating material; the free end (18) of said at least one tip (16; 17) of the articulating end (15) is exposed outside the protective cap (20); the body of the protective cap (20) is made of material impermeable to fluids and fumes; the at least one distal opening edge (26; 27) of the protective cap (20) is fitted with mechanical interference on the elongated body of said at least one tip (16; 17) of the electrosurgical instrument (10), resulting tight sealing adherent to the elongated body of the at least one tip (16; 17) of the electrosurgical instrument (10), for any operating configuration of the articulating end (15).

Description

"Active electrosurgical instrument and protective cap, particularly for medical-surgical teleoperation, and related robotic system"DESCRIPTION

[0001] . Field of the invention

[0002] . The present invention relates to an electrosurgical instrument.

[0003] . I n particular, the present invention relates to an assembly comprising said electrosurgical instrument and a protective cap.

[0004] . Furthermore, the present invention relates to a robotic system for medical or surgical teleoperation comprising said assembly.

[0005] . The present invention further relates to said protective cap.

[0006] . I n addition, the present invention further relates to 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] . I n the known surgical instruments having 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 tooperate 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] . I n fact, in the field of robotic surgery, the surgical instrument is a component intended to operate in a sterile environment and typically a sterile barrier is interposed between the “backend” portion of the instrument and the counter-portion of the actuation interface, so that the robotic manipulator is in the non-sterile region of the operating set-up. Therefore, the motors are normally placed in the manipulator, i.e. , on the non-sterile side, and the surgical instrument lacks motors.

[0013] . For example, US-10582975 and WO-2018-189721 to 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 forming the end-effector are made by wire electro-erosion.

[0014] . The use of metal tendons, such as tungsten strands, allows some predictability of the imparted actuation action because the length thereof does not vary significantly when under load. However, this type of metal tendons are typically of relatively large diameter and require dedicated guide channels or grooves on the parts of the end-effector with which they come into contact, imposing significant dimensions of the endeffector pieces. Usually, in fact, idle pulleys are mounted, i.e. , rotatable on the articulated end-effector links, to guide the metal tendon in the path thereof as well as fixed pulleys keyed onto the links of the end-effector which receive the dragging action imparted by the metal tendon which determines the actuation of an end-effector joint. Therefore, the use of metal tendons is an obstacle to an enhanced miniaturization of the end-effector.

[0015] . As shown, for example, in the prior art document US-2021 -106393 of the same Applicant, it is also known to make the actuation tendons in polymeric material to reduce the dimensions of the articulated cuff as well as the tendon-articulated cuff sliding friction coefficient. I n fact, by virtue of the provision of polymeric actuation tendons, it is possible to exploit a different operating principle based on the sliding of the polymeric tendons on dedicated sliding surfaces of the end-effector links lacking guide channels. This allows reducing local forces on the tendon because the tendon-link sliding contact area (in cross-section) is decreased, thus allowing more fragile but thinner tendons to be used. I n addition, it allows reducing the size of the end-effector links because guide channels for the tendon do not have to be dug.

[0016] . However, polymeric tendons are prone to non-recoverable stretching when in use (for example, plastic stretching and / or stretching due to the unraveling and readjustment of the braided fibers) , and this drawback is exacerbated in the case of enhanced miniaturization because, as the size of the articulated cuff made of surgical steel and actuated by tendons decreases, clearly, each longitudinal shortening or elongation of the length of a tendon drives a corresponding angular movement of the cuff which gradually becomes of increasing magnitude.

[0017] . Whereby, the provision of such polymeric tendons can impose dedicated control algorithms, as shown for example in WO-2022-264078, WO-2022-264075, WO-2022-264080 and WO-2023-047300 to the same Applicant, which can be aimed at avoiding unrecoverable elongations of the tendon itself when in use. For example, to avoid or at least minimize the occurrence of unrecoverable elongations of the polymeric tendon when in master-slave teleoperation, preload cycles can be carried out on all the braided polymeric tendons before the robotic system enables teleoperation.

[0018] . 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.

[0019] . The known electrosurgical instruments typically comprise oneor 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.

[0020] . Such articulated electrosurgical instruments are usually made of electrically non-conductive materials and preferably with high thermal stability and insulators such as non-conductive plastics (e.g. , LI LTEM) or ceramics with the sole exclusion of the conductive metal ends on which the electrical conductive cables terminate.

[0021] . 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.

[0022] . To electrically insulate such articulating ends of the active electrosurgical instrument, insulating sleeves are typically fitted on the entire end-effector, so as to form an electrically insulating barrier with respect to the patient's tissue near or in contact with the end-effector itself.

[0023] . 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 center 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).

[0024] . 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 applicationterminations (e.g. , "jaws") made of metal and to which they are connected.

[0025] . I n fact, in monopolar electrosurgical instruments, an electrical cable is typically provided, which extends inside the positioning rod or shaft of the surgical instrument from the transmission interface portion ("backend") to the articulated cuff. The positioning shaft is typically made of electrically insulating material while the operating tip of the electrosurgical instrument is electrically active in metal. I n 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.

[0026] . 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. I n 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) .

[0027] . It is also known to use electrically insulating sleeves which are fitted on the articulated cuff in order to avoid involuntary deliveries of electricity from areas other than the termination (both mono- and bipolar instruments) .

[0028] . I n the known solutions, although partially advantageous from some points of view, the problem of providing adequate and effective protection from the risks deriving from the electrosurgical action for the purpose of promoting an extreme miniaturization of the articulated endeffector remains open.

[0029] . Solution

[0030] . It is an object of the present invention to solve the described drawbacks of the prior art and propose a solution to the needs mentioned above.

[0031] . This and other objects are achieved with an assembly according to claim 1 , as well as with a protective cap according to claim 18, as well as with an electrosurgical instrument according to claim 19.

[0032] . Some advantageous embodiments are the subject of the dependent claims.

[0033] . According to an aspect of the invention, an electrosurgical instrument and protective cap assembly comprises an electrosurgical instrument and a protective cap.

[0034] . The electrosurgical instrument comprises a positioning shaft having a distal portion, an articulating end connected to the distal portion of the positioning shaft and comprising at least one tip of electrically conductive material having an elongated body forming a free end.

[0035] . The protective cap is fitted on the articulating end of the electrosurgical instrument and comprising a body of electrically and thermally insulating material comprising a proximal opening defined by a proximal opening edge of the cap body, at least one distal opening defined by at least one distal opening edge of the cap.

[0036] . The at least one tip of the articulating end is movable with respect to the positioning shaft and is actuated by means of at least one polymeric actuation tendon, the at least one tip of the articulating end comprises an actuation interface portion for receiving the actuation action of said at least one actuation tendon, said actuation interface portion of the at least one tip is inside the protective cap, the free end of said at least one tip of the articulating end is exposed outside the protective cap.

[0037] . The body of the protective cap is made of material impermeable to fluids and fumes, and the at least one distal opening edge of the protective cap is fitted with mechanical interference on the elongated body of said at least one tip of the electrosurgical instrument, resulting tight sealing adherent to the elongated body of the at least one tip of the electrosurgical instrument, for any operating configuration of the articulating end.

[0038] . The articulating end can have a plurality of polymeric actuation tendons including said at least one actuation tendon, each actuation tendon comprising an actuation distal end thereof, in which said protective cap covers the entire articulating end and all the distal actuation ends of the tendons of said plurality.

[0039] . Preferably, the protective cap covers all the rotational joints of the articulating end.

[0040] . Said at least one distal opening edge of the body of the protective cap is elastically stretchable, so as to be elastically preloaded against the elongated body of the at least one tip of the electrosurgical instrument thereby making, by means of elastic action, said mechanical interference and said tight sealing.

[0041] . The electrosurgical instrument can be of the monopolar type. According to an embodiment, the articulating end comprises two tips made of electrically conductive material each having an elongated body forming a free end, said two tips including said at least one tip, said two tips being relatively movable in opening / closing; in which the at least one distal opening comprises a single distal opening; and in which both of said two tips of the electrosurgical instrument are inside the protective cap with each of the respective free ends being exposed outside said single distal opening.

[0042] . The electrosurgical instrument can be of the bipolar type. According to an embodiment, the articulating end of the electrosurgical instrument comprises two tips of electrically conductive material each having an elongated body forming a free end, said two tips including said at least one tip; said two tips being relatively movable in opening / closing, in which the protective cap comprises two respective distal openings, including said at least one distal opening, defined by respective two distal opening edges, which are preferably disjoined from each other, and in which the free ends of said two tips of the articulating end are both exposed outside the protective cap, the distal opening edges are fitted with mechanical interference on the elongated body of the respective tips of the surgical instrument, resulting tight sealing adherent to the elongated body of the respective tip of the electrosurgical instrument, for any operating configuration of the articulating end, between the two tips of the electrosurgical instrument, the protective cap comprises a flap of insulating material, electrically and thermally insulating and impermeable to fluids and fumes, which partially delimits both of said distal opening edges.

[0043] . According to an aspect of the invention, a protective cap for anelectrosurgical instrument provided with an articulating end comprising at least one tip comprises a body of electrically insulating material comprising a proximal opening defined by a proximal opening edge of the cap body, at least one distal opening defined by at least one distal opening edge of the cap; in which the body of the protective cap is made of thermally insulating material; the body of the protective cap is made of material impermeable to fluids and fumes; the at least one distal opening edge of the protective cap is fitted with mechanical interference on the elongated body of said at least one tip of the electrosurgical instrument, resulting tight sealing adherent to the elongated body of the at least one tip, for any operating configuration of the articulating end.

[0044] . According to an aspect of the invention, a monopolar electrosurgical instrument comprises a positioning shaft having a distal portion, an articulating end connected to the distal portion of the shaft and comprising at least one tip made of electrically conductive material having an elongated body forming a free end; the at least one tip of the articulating end is movable with respect to the positioning shaft and is actuated by at least one actuation tendon; said at least one actuation tendon is made at least partially of polymeric material. The positioning shaft and the articulating end with said at least one tip are made of electrically conductive material, thereby making electrical continuity from the positioning shaft to the free end of the at least one tip of the articulating end, avoiding providing a separate electrical conductor which is terminated on said at least one tip.

[0045] . By virtue of the proposed solutions, the polymeric tendons of the articulating end are protected by the protective cap.

[0046] . Damage to the polymeric actuation tendons could occur as a result of heating the polymeric tendons themselves due to contact with fluids, vapors and fumes generated by the use of the electrosurgical instrument. I n fact, a local tendon temperature of over 80°C-90°C can melt the polymeric material of which the tendon consists and such vapors and fumes can exceed 100°C (water vapor).

[0047] . Damage to the polymeric actuation tendons could occur as a result of the absorption by the tendons themselves of the moisture of saidfluids, vapors and fumes, which would result in an increase in the electrical conductivity of the tendons themselves and therefore overheating due to the joule effect.

[0048] . By virtue of the proposed solutions, it is possible to avoid, during an electrosurgical intervention, the entry of fluids, vapors and fumes inside the protective cap which could directly affect the polymeric actuation tendons of the articulating end, damaging them .

[0049] . It therefore allows an extreme miniaturization of the articulating end of the electrosurgical instrument while allowing a precise, reliable and repeatable delivery of electricity without resulting in a reduced operating duration of the electrosurgical instrument itself.

[0050] . Brief description of the drawings

[0051] . 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. It should be noted 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. Furthermore, for reasons of conciseness and reduction of the total number of figures, a certain figure can be used to illustrate the features of more than one embodiment, and not all elements of the figure can be necessary for a certain embodiment.

[0052] . Figure 1 is a diagrammatic view showing an electrosurgical instrument and protective cap assembly, according to an embodiment, in which the electrosurgical instrument is of the monopolar type.

[0053] . Figure 2 is an axonometric view of an articulating end of an electrosurgical instrument and a protective cap, according to an embodiment.

[0054] . Figures 3 A and 3B are plan views of an articulating end of an electrosurgical instrument, according to an embodiment, in which figure 3B is made according to the viewpoint indicated by arrow B in figure 3 A, and in which some parts are omitted for clarity.

[0055] . Figure 4 A shows an electrosurgical instrument and protective cap assembly, according to an embodiment, in which the protective cap is shown in cross-section.

[0056] . Figure 4B shows the protective cap of the assembly in figure 4 A.

[0057] . Figures 4C and 4D show the assembly in figure 4 A in some operating configurations of the articulating end of the electrosurgical instrument.

[0058] . Figure 4E is a view taken from the viewpoint indicated by arrow E in figure 4 A.

[0059] . Figure 5 A shows an electrosurgical instrument and protective cap assembly, according to an embodiment in which the protective cap is shown in section.

[0060] . Figure 5B shows the protective cap of the assembly in figure 5 A.

[0061] . Figures 5C and 5D show the assembly in figure 5 A in some operating configurations of the articulating end of the electrosurgical instrument.

[0062] . Figure 5E is a view taken from the viewpoint indicated by arrow E in figure 5 A.

[0063] . Figure 6 A shows an electrosurgical instrument and protective cap assembly, according to an embodiment in which the protective cap is shown in section.

[0064] . Figure 6B shows the protective cap of the assembly in figure 6 A.

[0065] . Figures 6C and 6D show the assembly in figure 6 A in some operating configurations of the articulating end of the electrosurgical instrument.

[0066] . Figure 6E is a view taken from the viewpoint indicated by arrow E in figure 6 A.

[0067] . Figure 7 A shows an electrosurgical instrument and protective cap assembly, according to an embodiment in which the protective cap is shown in section.

[0068] . Figure 7B shows the protective cap of the assembly in figure 7 A.

[0069] . Figure 7C shows the assembly in figure 7 A in an operating configuration of the articulating end of the electrosurgical instrument.

[0070] . Figure 7D is a view taken from the viewpoint indicated by arrow D in figure 7 A.

[0071] . Figure 8 A shows an electrosurgical instrument and protective cap assembly, according to an embodiment in which the protective cap is shown in section.

[0072] . Figure 8B shows the protective cap of the assembly in figure 8 A.

[0073] . Figure 8C shows the assembly in figure 8 A in an operating configuration of the articulating end of the electrosurgical instrument.

[0074] . Figure 8D is a view taken from the viewpoint indicated by arrow D in figure 8 A.

[0075] . Figure 8E shows the assembly in figure 8 A in an operating configuration of the articulating end of the electrosurgical instrument.

[0076] . Figure 8F is a view taken from the viewpoint indicated by arrow F in figure 8E.

[0077] . Figure 8E is a view taken from the viewpoint of figure 8F in which the electrosurgical instrument comprises a surgical scissor.

[0078] . Figure 9 is a diagrammatic view showing an electrosurgical instrument and protective cap assembly, according to an embodiment, in which the electrosurgical instrument is of the monopolar type.

[0079] . Figure 10 A is a schematic axonometric view showing an electrosurgical instrument and protective cap assembly, according to an embodiment.

[0080] . Figure 10B shows the protective cap of the assembly in figure 10 A.

[0081] . Figure 10C is a view of the assembly in figure 10 A taken from the viewpoint indicated by arrow C in figure 10 A.

[0082] . Figure 1 1 A diagrammatically shows in axonometric view an electrosurgical instrument and protective cap assembly, according to an embodiment.

[0083] . Figure 1 1 B is a view of a portion of the assembly in figure 1 1 A, in which the protective cap is shown in section.

[0084] . Figures 1 1 C and 1 1 D diagrammatically show an electrosurgical instrument and protective cap assembly, according to an embodiment, in which the protective cap is shown in section.

[0085] . Figure 12 is a view of a portion of an assembly, according to an embodiment, in which the protective cap is shown in section.

[0086] . Figure 13 A is a raised vertical view pictorially showing a portion of an assembly, according to an embodiment.

[0087] . Figure 13B is a view taken from the viewpoint indicated by arrow B in figure 13 A.

[0088] . Figures 14 A-B show some possible steps of a manufacturing method, according to an embodiment.

[0089] . Figure 15 shows in section a mold for making a protective cap, according to an embodiment.

[0090] . Figure 16 shows in axonometric view a robotic system for medical or surgical teleoperation comprising said assembly, according to an embodiment.

[0091] . 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 this description do not necessarily all refer to the same embodiment. Moreover, particular features, structures or functions such as those shown in different drawings can be combined in any suitable manner in one or more embodiments.

[0092] . I n accordance with a general embodiment, an electrosurgical instrument and protective cap assembly 1 (or assembly 1 ) is provided, comprising an electrosurgical instrument 10 (or instrument 10) and aprotective cap 20.

[0093] . The electrosurgical instrument 10 is an active instrument 10 adapted to deliver energy to a patient, such as an electro-cautery instrument.

[0094] . The electrosurgical instrument 10 comprises a positioning shaft 13 having a distal portion 14 and an articulating end 15 operatively connected to the distal portion 14 of the rod.

[0095] . The articulating end 15 preferably comprises an articulated cuff defining two orthogonal axes of movement (e.g. , pitch P-P and yaw Y-Y).

[0096] . The articulating end 15 can comprise a vertebrae structure (snake) , for example of the type for flexible robotics. The positioning shaft 13 can also comprise a vertebrae structure.

[0097] . I n accordance with a preferred embodiment, the positioning shaft 13 is rigid. The positioning rod or shaft 13 preferably comprises an internally hollow elongated body, in which the actuation tendons 1 1 extend (for example three pairs of actuation tendons with antagonistic effects on three respective links of the articulating end) for example in the cavity of the elongated body of the positioning rod or shaft.

[0098] . The instrument 10 preferably further comprises a proximal transmission interface portion 34 ("backend") for interfacing with a respective transmission interface portion of the robotic system 2 for surgical teleoperation. The transmission interface portion 34 is preferably provided at the opposite end of the positioning shaft, i.e. , at the proximal end of the shaft.

[0099] . The articulating end 15 of the instrument 10 comprises at least one tip 16, 17 (or tip link 16, 17). Said at least one tip 16, 17 is made of electrically conductive material and has an elongated body forming at least one free end 18. The free end 18 of the tip 16 or 17 can be used when in operating conditions to deliver energy to the electrosurgical instrument 10, although the energy can also be delivered by other body portions of the tip 16, 17 of the articulating end 15, such as a gripping or cutting surface of the tip.

[0100] . The at least one tip 16; 17 of the articulating end 15 is movablewith respect to the positioning shaft 13 and is actuated by means of at least one actuation tendon 1 1. I n other words, the articulating end 15 comprises at least one degree of freedom thereof actuated by means of at least one actuation tendon 1 1 which moves the at least one tip 16, 17 with respect to the positioning shaft 13. I n particular, the at least one tip 16; 17 of the articulating end 15 comprises an actuation interface portion 19 for receiving the actuating action of said at least one actuation tendon 1 1 .

[0101] . Of course, said at least one tip 16, 17 is preferably made in a single piece as a single block of electrically conductive material and therefore the actuation interface portion 19 of the tip 16, 17 can comprise a termination seat or groove 19 with undercut walls cooperating with an enlarged distal portion 12 of the actuation tendon 1 1 for the actuation tendon to move the tip 16, 17.

[0102] . The actuation interface seat 19 is preferably arranged opposite with respect to the free end 18 of the tip, with respect to the longitudinal extension of the body of said tip 16, 17. The actuation interface portion 19 is preferably provided near the attachment root 38 of the tip link, i.e. , near the joint pin 37 of the movement rotational joint of the tip link 16 or 17. The actuation tendon 1 1 preferably wraps around a cylindrical surface (a kind of fixed pulley in a single piece) of the attachment root 38 of the tip link and terminates in the actuation interface seat 19 thereof.

[0103] . I n accordance with an embodiment, said at least one tip 16, 17 is made by wire electro-erosion machining (WEDM , or Spark Erosion) starting from a workpiece made of electrically conductive material, such as metal, for example surgical steel.

[0104] . I n accordance with an embodiment, the articulating end 15 of the surgical instrument comprises two tips 16, 17 made of electrically conductive material, each having an elongated body forming a free end 18 thereof (said two tips 16, 17 including said at least one tip previously described) . I n this case, the electrosurgical instrument 10 can be a monopolar or bipolar instrument, as explained below. If two tips 16, 17 are included, at least one actuation tendon 1 1 can be provided for each of them, and preferably a pair of antagonistic actuation tendons for each of them .Where two tips 16, 17 are included, they can work as jaws, i.e. , they can be movable with respect to each other in opening / closing OP / CL.

[0105] . The articulating end 15 can comprise, in addition to said at least one tip 16, 17, a support link 35, which is preferably articulated in a rotational joint to the at least one tip 16, 17, so that the at least one tip 16, 17 is constrained to rotate with respect to the support link 35 around a rotation axis Y-Y (e.g. , rotation axis of yaw Y-Y) . The support link 35 can comprise one or more prongs 36 defining a through seat which receives an joint pin 37 and also a portion of attachment root 38 of the at least one tip 16, 17, thereby forming said rotational joint with rotation axis of yaw Y-Y. A further proximal link 41 articulated to the support link 35 can be included. The rotation axis of pitch P-P of the rotational joint between support link 35 and proximal link is preferably orthogonal to the rotation axis of yaw Y-Y.

[0106] . Said at least one actuation tendon 1 1 for moving the tip 16, 17 with respect to the positioning shaft 13 is made, at least partially, of polymeric material. Preferably, the at least one actuation tendon 1 1 is made exclusively of polymeric material. Therefore, the at least one actuation tendon 1 1 is unsuitable for electrically powering the at least one tip 16, 17 of the articulating end 15 of the electrosurgical instrument 10 because it is unsuitable for acting as an electrical conductor.

[0107] . The at least one actuation tendon 1 1 can be a braided polymeric tendon formed by a plurality of polymeric fibers which are braided together. The polymeric fibers can be made of high molecular weight polyethylene (LI H MWPE) . The tendon 1 1 can comprise a covering portion made of braided polymeric fibers and a core portion, inside the covering portion, which can be formed by braided polymeric fibers.

[0108] . The electrosurgical instrument 10 further comprises at least one electrical conductor for electrically powering the at least one tip 16, 17 in operating connection therewith. For example, the electrical conductor can comprise an electrical cable which ends on the electrically conductive body of said at least one tip 16, 17 and is connected, at the other end thereof, to an electric generator 39. For example, the electrical conductor can also comprise at least one portion of the positioning shaft 13 (or positioning rod),in which said portion can be made of electrically conductive material. The positioning rod or shaft 13 can comprise a coating of electrically insulating material, such as a sheath 47, and the protective cap 20 can have the proximal opening edge 23 thereof adhered to the sheath 47. For example, the positioning shaft 13 can comprise a conductor arranged inside the electrically insulating body of the positioning rod or shaft.

[0109] . I n accordance with a preferred embodiment, both the positioning shaft 13 and the articulating end 15 are made of electrically conductive material themselves forming the electrical conduction path for powering the at least one tip 16, 17 of the electrosurgical instrument 10 in electrical connection with the electric generator 39. Preferably, the support link 35 and where provided the proximal link 41 are made of electrically conductive material. The joint pins 37 can also be made of electrically conductive material.[001 10]. By virtue of making the at least one actuation tendon 1 1 in polymeric material, a very low sliding friction of the tendon 1 1 is allowed on the special sliding surfaces 40 thereof provided on the body of the articulating end 15 of the electrosurgical instrument 10. The sliding surfaces are preferably convex ribbed surfaces with generatrices parallel to the rotation axis of pitch (pitch) P-P or yaw (yaw) Y-Y, in a manner known per se. The body of the support link 35 preferably comprises one or more sliding surfaces 40 for the at least one actuation tendon 1 1 to move the at least one tip 16, 17, in a manner known per se. The at least one actuation tendon 1 1 slides on said one or more sliding surfaces 40 when it is pulled to move the tip 16 around the rotation axis Y-Y. As shown for example in figure 2, the tip 16 can comprise two opposite seats 19 each receiving an actuation tendon 1 1 of a pair of actuation tendons having antagonistic effect. The convex and ribbed sliding surfaces 40 can comprise surfaces facing the center-line of the articulating end 15 and for example the support link 35 can comprise several convex ribbed sliding surfaces in which one ribbed sliding surface is generated by lines parallel to the axis of pitch P-P and another ribbed sliding surface is generated by lines parallel to the axis of yaw Y-Y (orthogonal to the axis of pitch) .[001 11 ]. . To actuate the support link 35, one or more tendons 45 can be provided, which end on the support link and can slide on special sliding surfaces of the proximal link 41 . The proximal link 41 can be fastened to the positioning shaft 13, forming the distal portion 14 of the shaft itself. The proximal link 41 can comprise at least one sliding surface thereof for at least one actuation tendon 1 1 or 45 for moving the at least one tip link 16, 17 or support link 35.[001 12]. As mentioned above, the assembly 10 further comprises a protective cap 20. Advantageously, said protective cap 20 is fitted on the articulating end 15 of the electrosurgical instrument 10 and comprises a body of electrically insulating material. I n other words, the body of the protective cap 20 has electrical insulation properties while the at least one tip 16, 17 is made of electrically conductive material.[001 13]. For example, before starting an electrosurgical intervention which involves the use of the electrosurgical instrument 10, the protective cap 20 is fitted in the manner of a sock on the articulating end 15 so as to expose the at least one tip 16, 17 forming the at least one active exposed portion of the electrosurgical instrument 10.[001 14]. The protective cap 20 comprises a proximal opening 22 defined by a proximal opening edge 23 of the cap body and at least one distal opening 24, 25 defined by at least one distal opening edge 26, 27 of the cap. The proximal opening edge 23 can be fitted on the positioning shaft 13 and the at least one distal opening edge 26, 27 can be fitted on the at least one tip 16, 17.[001 15]. With further advantage, said actuation interface portion 19 of the at least one tip 16, 17 receiving said at least one actuation tendon 1 1 made of polymeric material is inside the protective cap 20. Thereby, the protective cap 20 also acts as a protective device for the at least one actuation tendon 1 1 with the distal portion 12 thereof, for example an enlarged distal portion such as forming a knot for exerting the pulling action on the tip link.[001 16]. I n particular, the body of the protective cap 20 is made of material impermeable to fluids and fumes ("fluid" is meant herein to indicateboth gases and vapors and also meant to indicate fumes which for example are released by the electro-cauterizing action, as well as mixtures and liquids) . I n other words, the body of the protective cap 20 is made of a material which is both electrically insulating and impermeable to fluids, vapors and fumes.[001 17]. he impermeability of the protective cap 20 makes it possible to protect the actuation tendons 1 1 from wetting, i.e. , it prevents the polymeric actuation tendons 1 1 from being soaked with fluids, such as biological fluids, gases, vapors but also fumes deriving from the electro-cauterizing action applied by means of the at least one tip 16, 17 of the articulating end 15 of the instrument 10.[001 18]. By virtue of the protective cap 20, it is possible to protect the polymeric actuation tendons 1 1 from excessive overheating which would be caused by the direct exposure of the actuation tendons 1 1 to fluids, vapors and fumes deriving from the electro-cauterizing action.[001 19]. With further advantage, the at least one distal opening edge 26, 27 of the protective cap 20 is fitted with mechanical interference on the elongated body of said at least one tip 16, 17 of the surgical instrument 10, resulting tight sealing adherent to the elongated body of the at least one tip 16, 17 of the electrosurgical instrument 10. Preferably, the sealing adhesion of the distal opening edge of the cap occurs substantially halfway up the tip i.e. , in a portion of the tip which is intermediate between the attachment root 38 and the free end 18.

[0120] . The mechanical interference is the consequence of the stretching of the body of the protective cap 20 operated by the body of the at least one tip 16, 17 of the articulating end 15 of the instrument 10.

[0121] . I n accordance with a preferred embodiment, the body of the protective cap 20 is made of thermally insulating material. Thereby, the body of the protective cap 20 itself is capable of protecting the actuation tendons 10 from excessive overheating which could degrade the performance thereof, in addition to forming a tight sealing barrier around the conductive tip 16, 17 of the articulating end.

[0122] . The at least one tip 16, 17 can have a tapered shape(comprising, for example, a tapered portion 29) i.e. , tapering towards the distal end 18 so as to facilitate the stretching by mechanical interference of the protective cap during the operations of fitting the cap on the at least one tip 16, 17. The tapered portion can form a spout. The tapered portion can form an inclination of 10°-30° with a definable longitudinal direction of the cap as well as of the articulating end.

[0123] . The stretching by mechanical interference of the at least one distal opening edge 26; 27 can occur by plastic stretching of the body of the protective cap 20.

[0124] . I n accordance with an embodiment, the at least one tip16, 17 comprises a quadrangular cross-section and the edge 26, 27 of the at least one distal opening 24, 25 has a substantially circular shape when in resting conditions, which is stretched by mechanical interference from the tapered walls of the body of the at least one tip16, 17 of the articulating end 15 during the fitting operations of the cap 20 on the tipi 5. Preferably, the at least one tip 16 comprises a body having a quadrangular cross-section having two pairs of substantially flat opposite faces 42, 43 forming edges with each other, and in which each face 42, 43 has a trapezoidal or triangular cross-section such that the edges 44 are converging, forming a tapered tip 16. Where two tips 16, 17 movable in opening / closing OP / CL are provided, respective faces 43 can operate as contact surfaces between the two tips, such as gripping and / or cutting surfaces, or other type of operating surface.

[0125] . To fit the protective cap 20 on the articulating end 15, preferably proceed by first providing the articulating end 15 completely assembled to the positioning shaft 13 and inserting the at least one tip in the cavity 21 inside the body of the cap 20 from the proximal opening 22.

[0126] . The at least one distal opening 26, 27 of the protective cap 20 can be created by perforating the body of the protective cap 20 made with the at least one tip 16, 17 of the articulating end 15. I n other words, the protective cap 20 can be produced without the at least one distal opening 26, 27 and then perforated by the at least one tip of the electrosurgical instrument.

[0127] . The tight sealing adhesion is maintained for any operating configuration of the articulating end 15. Thereby, whatever the orientation of the at least one tip 16, 17 with respect to the positioning shaft 13, the tight sealing of the protective cap 20 is ensured, which prevents the entry of vapors and fumes inside the cavity 21 of the cap. For example, the sealing adhesion is maintained, by virtue of such a protective cap 20, for any operating configuration of the kinematic chain of the articulating end 15 (rotational joints P-P and Y-Y) as well as in both active energy delivery conditions and in deactivated energy delivery conditions.

[0128] . The polymer material of the tendons can incur premature and undesirable degradation when exposed to the fluids listed above under operating conditions, and result in poor mechanical properties (plastic elongations and / or local melting of the polymeric material) or poor electrical properties (conductivity through the body of the tendon itself) .

[0129] . By virtue of the provision of said protective cap 20, it is possible to avoid, or at least minimize, the risk that the polymeric actuation tendons 1 1 designed to exert a mechanical pulling action aimed at moving the at least one tip 16, 17 of the articulating end 15 get wet with the fluid products and fumes of the electrosurgical or microsurgical intervention as well as excessively overheat with consequent degradation of the mechanical properties (plasticity) of the polymeric tendon itself.

[0130] . I n accordance with an embodiment, said at least one distal opening edge 26, 27 of the body of the protective cap 10 is elastically stretchable, so as to be elastically preloaded against the elongated body of the at least one tip 16, 17 of the electrosurgical instrument, thereby making, by means of elastic action, said mechanical interference and said tight sealing. The elastic action exerted by the distal opening edge 26, 27 of the protective cap 20 on the body of the at least one tip 16, 17 determines the tight sealings.

[0131] . I n accordance with a preferred embodiment, in which said articulating end 15 has a plurality of polymeric actuation tendons 1 1 , 45 including said at least one actuation tendon, each actuation tendon comprising a distal actuation end 12 thereof (e.g. , for actuating the at leastone tip link 16 and / or 17 and / or the support link 35) , said protective cap 20 covers the entire articulating end 15 and all the distal actuation ends 12 of the tendons of said plurality. Thereby, an adequate protection is made for all the actuation tendons 1 1 , 45 by means of the use of said protective cap 20. Preferably, all the rotational joints of the articulating end 15 are inside the protective cap 20.

[0132] . I n accordance with a preferred embodiment, the protective cap 20 is fitted on the positioning shaft 13 of the surgical instrument 10 with the proximal opening edge 23 of the cap resulting tight sealing adherent against said positioning shaft 13, for example in the distal portion 14 of the shaft. The provision of a tight seal made by the proximal end 23 of the protective cap 20 allows further improving the protection offered to the actuation tendons 1 1 . To this end, the proximal opening edge 23 can be made elastically stretchable so as to be elastically preloaded against the body of the positioning shaft 13 of the surgical instrument 10. The positioning shaft 13 as well as the distal portion 14 thereof can have a substantially cylindrical shape.

[0133] . The protective cap 20 is preferably made in a single piece.

[0134] . I n accordance with an embodiment, as shown for example in figures 4 A-E, the body of the protective cap 20 comprises a single distal opening 26 having a smaller caliber than the proximal opening 22, and a tapered portion 29, i.e. , which narrows therebetween, and the instrument 10 comprises a single tip 16 (in this case the instrument is a monopolar electrosurgical instrument) . The insertion of the tip 16 into the distal opening 24 stretches the distal opening edge 26.

[0135] . The proximal opening edge 23 can be formed by an enlarged portion, such as by an enlarged collar 32 to improve the gripping and sealing on the positioning shaft 13 of the instrument 10.

[0136] . I n accordance with an embodiment, as shown for example in figures 5 A-E, the body of the protective cap 20 comprises a tapered portion 29 and the distal edge 26 is elongated and tapered to increase the contact surface with the body of the tip 16 of the articulating end 15 (in this case the instrument is a monopolar electrosurgical instrument).

[0137] . I n accordance with an embodiment, as shown for example in figures 6 A-E, the body of the protective cap 20 comprises a folded extendable portion 31 comprising a plurality of material folds, so as to accommodate various operating configurations of the articulating end 15 (in this case the instrument is a monopolar electrosurgical instrument) . When in operating conditions, the provision of said material folds allows a reserve of material which avoids or at least reduces the risk of dragging actions carried out by the resistance to stretching of the cap 20 on the at least one tip 16, 17.

[0138] . I n accordance with an embodiment, as shown for example in figures 7 A-D, the body of the protective cap 20 forms an enlarged collar in the distal opening edge 26, to contribute to achieving the tight seal (in this case the instrument is a monopolar electrosurgical instrument).

[0139] . Where the electrosurgical instrument 10 is of the monopolar type, for example it can be a needle and / or a scalpel and / or a hook. The electrosurgical instrument 10 can be of the monopolar type and comprise two tips 16, 17, such as a monopolar scissor (figure 8-G) and / or a monopolar dilator (figure 8-D) .

[0140] . I n accordance with an embodiment, the articulating end 15 of the electrosurgical instrument 10 comprises two tips 16, 17, both made of electrically conductive material and each having an elongated body forming a free end 18 thereof, in which said two tips include said at least one tip, and in which said two tips are relatively movable in opening / closing OP / CL. For example, the two tips 16, 17 are constrained to rotate around a common axis Y-Y (e.g. , an axis of yaw) , by means of the provision of a rotational pin joint.

[0141] . An electrosurgical instrument 10 having said two tips 16, 17 relatively movable in opening / closing OP / CL can be an active monopolar or bipolar instrument.

[0142] . I n accordance with an embodiment, the at least one distal opening of the protective cap 20 comprises a single distal opening 24 and both of said two tips 16, 17 of the instrument 10 are inside the cavity 21 of the cap, i.e. , both are exposed outside the protective cap 20 from said singledistal opening 24. I n other words, each of the respective free ends 18 of the two tips 16, 17 is outside said one distal opening 24. I n this case, the electrosurgical instrument 10 is preferably of the monopolar type and both tips 16, 17 can be polarized with the same charge. Said two tips 16, 17 can be relatively movable in opening / closing OP / CL to carry out a gripping and / or cutting and / or dilating action. I n addition to the free ends 18, an operating distal section of the tips 16, 17, such as gripping and / or cutting and / or dilating surfaces, is also exposed outside the protective cap 20.

[0143] . I n accordance with another embodiment, the articulating end 15 of the electrosurgical instrument 10 comprises two tips 16, 17 made of electrically conductive material, each having an elongated body forming a free end 18, in which said two tips include said at least one tip, and in which said two tips being relatively movable in opening / closing OP / CL, and in which the protective device 20 comprises two respective distal openings 24, 25, which include said at least one distal opening, defined by two respective distal opening edges 26, 27, and in which the free ends 18 of said two tips 16, 17 of the articulated cuff 15 are both exposed outside the protective device; and in which the distal opening edges 26, 27 are fitted with mechanical interference on the elongated body of the respective tips 26, 27 of the instrument, individually resulting tight sealing adhered to the elongated body of the respective tip 16, 17 of the electrosurgical instrument, for any operating configuration of the articulated cuff. The two distal openings 26 and 27 are separated from each other. I n this case, the instrument 10 is a bipolar instrument having different polarities between the two tips 16, 17. The tips 16, 17 of the bipolar electrosurgical instrument 10 can comprise curved portions 46 or variously shaped to allow the free ends 18 to contact each other before the respective proximal portions in reclosing and / or can be shaped so that the only area of contact between the tips 16, 17 is located near the free ends 18, avoiding contacts between the tips in a proximal portion thereof near the joint pin 37.

[0144] . I n accordance with a preferred embodiment, between the two tips 16, 17 of the bipolar instrument 10, the protective cap 20 comprises a flap 28 of insulating, electrically insulating and fluid-impermeable material,partially delimiting both of said distal opening edges 26, 27. The provision of said flap of insulating material 28 allows keeping the two tips 16, 17 of the bipolar active instrument separated without contact, avoiding short circuits between the two tips with different polarities. Said flap of insulating material 28 between the tips 16, 17 is preferably also thermally insulating.

[0145] . Said flap of insulating material 28 can be made of the same material as the rest of the body of the protective cap 28. Preferably, the flap 28 thus extends seamlessly with the rest of the body of the protective cap.

[0146] . The mechanical, as well as local electrical and / or thermal insulation properties of the flap 28 of material between the two tips 16, 17 can be adjusted by acting on the shape and thickness of the flap of material 28.

[0147] . Said flap 28 of insulating material between the two distal openings 26, 27 of the protective cap 20 can have a lower rigidity with respect to the rest of the body of the cap 20. Said flap of insulating material 28 between the two distal openings 26, 27 of the protective cap 20 can have a greater elasticity than the rest of the protective device. Said flap of insulating material 28 between the two distal openings 26, 27 of the protective cap 20 can have a smaller thickness than the rest of the protective device. Said flap of insulating material 28 between the two distal openings 26, 27 of the protective cap 20 can have a bellows shape, comprising an extendable folded portion 31 with a plurality of material folds to accommodate the movement of opening / closing OP / CL of the tips 16, 17 of the articulating end 15.

[0148] . As mentioned above, said articulating end 15 is preferably made of electrically conductive material, for example metal, and preferably thermally conductive. Preferably, said articulating end 15 is formed by a plurality of links (including said support link 35, said proximal link 41 , and said at least one tip 16, 17 in electrically conductive material, the links of said plurality being mechanically connected to each other (for example by means of electrically conductive joint pins) forming an electrically conductive articulated kinematic chain. Not necessarily each link 41 , 35 is formed in a single piece. At least some of said links can comprise a clevisshape with two prongs 36 for assembling the joint pin. As mentioned above, the proximal link 41 can be fixed with respect to the distal end of the positioning shaft, forming the distal portion 14 of the positioning shaft 13 itself.

[0149] . As mentioned above, the body of the protective cap 20 can comprise at least one extendable portion for accommodating various operating configurations of the articulating end 15, for example during the activation of the rotational joints of pitch, yaw and / or opening / closing.

[0150] . Said extendable portion can comprise or be formed by a folded portion 31 , forming a plurality of material folds, so as to follow the movement of the articulating end 15 with minimum mechanical resistance.

[0151] . I n accordance with a preferred embodiment, said extendable portion comprises an elastically stretchable portion.

[0152] . The at least one distal opening edge 26, 27 of the protective cap 20 can be formed by an enlarged collar 32. The proximal opening edge 23 of the protective device can be formed by an enlarged collar 32. The provision of the enlarged collar contributes to making the tight closure.

[0153] . The body of the protective cap 20 is preferably made of a polymeric, biocompatible and transparent material, such as rubber or plastic.

[0154] . Preferably, the cap is made of silicone such as PDMS (poly- dimethyl-siloxane) .

[0155] . The body of the protective cap 20 preferably has a thickness belonging to the range 0. 1 -0.5 millimeters, and preferably belonging to the range 0.2-0.3 millimeters, which is not necessarily constant in the various portions of the cap 20. For example, the thickness of the protective cap can be less in the tapered area forming the spout. For example, the thickness of the protective cap can be greater at the proximal and / or distal opening edges.

[0156] . For example, in accordance with an embodiment, the protective cap comprises a body having a thickness of 0.3 millimeters forming a proximal opening edge with an enlarged collar having a local thickness of 0.5 millimeters, in which the diameter of the proximal through opening is 3.8millimeters, suitable for sealing on a positioning shaft 4 millimeters in diameter, and the diameter of the distal through opening is 0.4 millimeters; the spout portion, according to this example, has an inclination in the range of 20° to 30° with respect to a definable longitudinal direction; the longitudinal extension of the protective cap is 12 millimeters, according to this example.

[0157] . For example, according to another embodiment, the protective cap comprises a body having a thickness of 0.2 millimeters forming a proximal opening edge with an enlarged collar having a local thickness of 0.4 millimeters, in which the diameter of the proximal through opening is 3.8 millimeters, suitable for sealing on a positioning shaft 4 millimeters in diameter, and the diameter of the distal through opening is 0.4 millimeters; the spout portion, according to this example, has an inclination in the range of 20° to 30° with respect to a definable longitudinal direction; the longitudinal extension of the protective cap is 12 millimeters, according to this example.

[0158] . The material used to make the protective cap is, according to an embodiment, silicone with hardness belonging to the range 20A-40A. According to an embodiment, the thickness of the protective cap body is 0.2 mm , ensuring an electrical insulation of about 2800 V / mm. The protective cap 20 can be optically translucent, made of an optically translucent silicone.

[0159] . Preferably, the protective cap 20 is made by molding. For example, micro-molding technologies such as injection-molding can be employed. For example, the protective cap 20 can be made by dip molding.

[0160] . As shown for example in figures 14 A-B, the protective cap 20 can be made by dip-molding (dipping) a silicone material , providing a support 51 on which a plurality of male elements 52 are assembled, for example made of metal and having a tapered shape, i.e. , which narrows at the tip. The support 51 with the male elements 52 is immersed in a tank containing the starting material of the cap, such as silicone. The tank as well as the male elements 52 can be heatable. After immersion, the support 51 with the male elements 52 coated with polymeric material is arranged ona structure for drying.

[0161] . As shown for example in figure 15, the protective cap 20 can be made by injection-molding by including a mold 60 in two parts 61 , 62, in which one part 61 of the two parts of the mold comprises a male element 63 or core 63 and the other part 62 of the mold comprises a corresponding female element 64. The mold or at least the male and female elements preferably have a cylindrical geometry. Between the male element and the female element a mold cavity 65 is formed which is filled by the material (silicone, for example) .

[0162] . By changing the size of the female element 64 (e.g. , by making a wider female seat) while keeping the male element the same, it becomes possible to adjust the thickness of the resulting protective cap 20 because a thicker mold cavity 65 is made, resulting in a thicker protective cap. By changing the size of the male element 63 (for example by making a thinner core) , keeping the female seat the same, it becomes possible to adjust the thickness of the resulting protective cap 20 because a thicker mold cavity 65 is made, resulting in a thicker protective cap.

[0163] . The body of the protective cap 20 can form a visible line 33 of material at a change in inclination as an effect of the molding process.

[0164] . I n accordance with an embodiment, the entire tip link 16, 17 or at least only the distal end 18 thereof is made of metal, and electrical conductor wires are provided, which are connected directly to said tip link 16, 17 or at least the distal end 18 thereof, which can also be wound onto the links (e.g. , said support links 35 and proximal link 41 ) of the articulating end 15 of the electrosurgical instrument 10. I n accordance with an embodiment, one or more conductor cables run along the positioning shaft 13 and carry the voltage to the entire metal articulating end 15. I n accordance with an embodiment, such conductor cables run inside the positioning shaft 13. I n accordance with an embodiment, such conductor wires run outside the positioning shaft of the instrument.

[0165] . I n accordance with an embodiment, the positioning shaft is also made of metal and is used as a conductor to bring the voltage to the conductive metal articulating end 15 up to the tips 16, 17 thereof. Thepolymeric actuation tendons 1 1 can be low friction and high rigidity tendons.

[0166] . During the use of the electro-cauterizing function on the biological tissue to be treated, hot vapors and fumes are released which could quickly damage the polymeric tendons 1 1 , which are not resistant to thermal stresses as are the known steel or tungsten actuating cables typically used in the known electrosurgical instruments.

[0167] . During the use of the electro-cauterizing function, the tissue surrounding the treated area is heated and by virtue of the provision of said protective cap 20, the overheating of the polymeric tendons 1 1 is avoided by direct contact with overheated tissue as well as by direct exposure to the flow of vapors and fumes.

[0168] . The protective cap 20 is preferably in close contact with the at least one tip 16, 17 and moves therewith. The protective cap 20 is preferably also in contact with the link 35 of the articulating end 15 and moves therewith. I n accordance with an embodiment, the protective cap 20 can be glued to the body of the support link 35.

[0169] . The distal opening 26, 27 elastically stretches with the opening / closing of the tips 16, 17 maintaining thermal insulation and tight sealing, therefore preventing access of vapors and / or fumes to the cavity 21 . Where included, a bellows-shaped folded extendable portion 31 minimizes the resistance offered by the cap itself during the movement of the articulating end 15.

[0170] . The double-hole distal opening (i.e. , the two separate distal openings 26, 27 of the protective cap 20) allows the tips 16, 17 to open and close while maintaining effective insulation. Preferably, said two distal holes 26, 27 of the cap 20 have an offset with respect to the direction of opening / closing OP / CL, i.e. , in other words the distal openings 26, 27 are not aligned with the relative approaching / distancing direction of the tips 16, 17 i.e. , the direction of opening / closing OP / CL, as shown for example in figure 13B. I n accordance with an embodiment, the two distal holes 26, 27 of the cap 20 have a central symmetry with respect to the axis of the positioning shaft 13 of the electrosurgical instrument 10 and / or with respect to a definable longitudinal axis of the articulating end.

[0171] . I n accordance with a general embodiment, a robotic medical or surgical teleoperation system 2 is provided, comprising at least one assembly 1 comprising an electrosurgical instrument and a protective cap according to any of the previously described embodiments.

[0172] . The robotic system 2 further comprises an electric generator 39 for polarizing the at least one tip 16, 17.

[0173] . The robotic system 2 preferably further comprises a transmission interface 3 which engages with the respective proximal transmission interface (backend) 34 of the instrument 10.

[0174] . Preferably, the robotic system 2 comprises at least two instruments in which one is an electrosurgical instrument 10 and the other is a non-active instrument i.e. , unsuitable for transferring electrical / thermal energy to tissues and disconnected from the electric generator 39.

[0175] . The robotic system preferably comprises a master console 4 comprising at least one master control device (not shown) for carrying out teleoperation, controlling the electrosurgical instrument. I n particular, the robotic system 2 can comprise one or more robotic manipulators 5 operable under the control of the master console 4. The transmission interface 3 is preferably part of the manipulator 5. A sterile barrier can be interposed between the transmission interface 3 of the manipulator 5 and the proximal transmission interface 34 of the electrosurgical instrument 10.

[0176] . I n accordance with a preferred embodiment, the robotic system 2 further comprises at least one foot switch pedal 30 for controlling the delivery of energy by the electrosurgical instrument. Said foot switch pedal 30 is preferably in operating connection with the electric generator 39.

[0177] . The robotic system 2 can further comprise an operating bed or table 6 on which the patient 7 lies when in operating conditions.

[0178] . If the electrosurgical instrument is of the monopolar type, then a return electrode 8 separated from the articulating end 15 of the instrument 10 is preferably included. I nstead, if the electrosurgical instrument is of the bipolar type, the return electrode is formed by one of the two tips 17 or 16 while the other tip 16 or 17 forms the active electrode.

[0179] . The electric generator 39 can be mounted inside the roboticmanipulator 5 or it can be provided separately and electrically connected to the at least one tip 16, 17 of the articulating end 15.

[0180] . I n accordance with a general embodiment, a protective cap 20 for an electrosurgical instrument 10 is provided.

[0181] . The protective cap 20 can be a protective cap 20 according to any one of the embodiments described above.

[0182] . I n particular, according to a preferred embodiment, the protective cap 20 is for an electrosurgical instrument 10 provided with an articulating end 15 comprising at least one tip 16; 17, said protective cap 20 comprising a body of electrically insulating material comprising a proximal opening 22 defined by a proximal opening edge 23 of the cap body, and at least one distal opening 24; 25 defined by at least one distal opening edge 26; 27 of the cap.

[0183] . The protective cap preferably has a body forming a through sleeve between the proximal 22 and distal 24, 25 openings.

[0184] . Advantageously, the body of the protective cap 20 is made of a material which is impermeable to fluids and fumes.

[0185] . The body of the protective cap 20 is preferably both electrically and thermally insulating.

[0186] . With further advantage, the at least one distal opening edge 26; 27 of the protective cap 20 is fitted with mechanical interference on the elongated body of said at least one tip 16; 17 of the electrosurgical instrument 10, resulting tight sealing adherent to the elongated body of the at least one tip 16; 17, for any operating configuration of the articulating end 15.

[0187] . I n accordance with a general embodiment, an electrosurgical instrument 10 of the monopolar type is provided.

[0188] . The monopolar electrosurgical instrument can be an electrosurgical instrument according to any one of the above-described embodiments of monopolar electrosurgical instruments.

[0189] . I n particular, in accordance with a preferred embodiment, the monopolar electrosurgical instrument comprises a positioning shaft 13 having a distal portion 14 and an articulating end 15 connected to the distalportion 14 of the shaft and comprising at least one tip 16; 17 in electrically conductive material having an elongated body forming a free end 18, in which the at least one tip 16; 17 of the articulating end 15 is movable with respect to the positioning shaft 13 and is actuated by at least one actuation tendon 1 1 , in which said at least one actuation tendon 1 1 is made of polymeric material.

[0190] . Advantageously, the positioning shaft 13 and the articulating end 15 with said at least one tip 16, 17 are all made of electrically conductive material, thereby making electrical continuity from the positioning shaft 13 to the free end 18 of the at least one tip of the articulating end, avoiding providing a separate electrical conductor which is terminated on said at least one tip. An insulating sheath 47 can be provided to cover the conductive positioning shaft 13.

[0191] . I n accordance with an embodiment, the articulating end 15 comprises a support link 35 between the positioning shaft 13 and the at least one tip 16, 17, in which said support link 35 forms with the at least one tip 16, 17 a rotational pin joint comprising a joint pin 37 also made of electrically conductive material.

[0192] . Preferably, the rotational pin joint is formed by said support link 35 which is intimately in contact with said at least one tip 16, 17 to maximize the contact surface.

[0193] . I n accordance with a preferred embodiment, the support link 35 defines in a single piece two rotational pin joints having mutually orthogonal axis P-P, Y-Y, for example axes of pitch P-P and axes of yaw Y-Y.

[0194] . I n accordance with an embodiment, the electrosurgical instrument 10 is configured to rotate in the entirety thereof around a definable rotation axis of roll which preferably coincides with the longitudinal axis of the positioning shaft 13. Preferably, at least the positioning shaft 13 and the articulating end 15 are integral in roll rotation around said definable roll rotation axis which is preferably coincident with the longitudinal extension axis of the positioning shaft, in particular in combination with the provision of the rigid and straight positioning shaft.

[0195] . By virtue of the features described above, provided in mutualcombination or not in particular embodiments, it is possible to meet to the aforementioned needs, thus achieving the aforementioned advantages, and in particular:

[0196] . - it allows making a protective cap adapted to protect the polymeric tendons from excessive heating, wetting, corrosion, due to the release of fumes and vapors during the electro-cauterizing action;

[0197] . - it prevents the polymeric actuation tendons from getting soaked, thus preventing them from conducting electricity and heating up due to the Joule effect;

[0198] . - at the same time, it allows eliminating, or at least minimizing, the risk of unwanted contact between the articulating end and the tissue of the patient to be treated;

[0199] . - miniaturized electrified tools are provided which join high- strength articulated metal parts to withstand the actuation forces and low- friction and high rigidity polymeric tendons to allow the sliding and transmission of the adequate closing forces;

[0200] . - miniaturized articulated instruments are provided which are adapted to minimize the number of components to be assembled;

[0201] . - miniaturized articulated instruments are provided with dimensional tolerances which are difficult to reach with plastic or other electrically insulating materials;

[0202] . - articulated miniaturized instruments are provided which, if necessary, can be produced without plastic or ceramic parts in the articulating end 15;

[0203] . - the links 41 , 35, 16, 17 of the miniaturized electrosurgical instrument are made of metal material and are subjected to electrical voltage.

[0204] . It is well understood that the combinations of features disclosed in the appended claims form an integral part of the present disclosure.

[0205] . I n 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

CLAIM S1. Electrosurgical instrument and protective cap assembly (1 ) comprising: an electrosurgical instrument (10) comprising:- a positioning shaft (13) having a distal portion (14) ,-an articulating end (15) coupled to the distal portion (14) of the shaft and comprising at least one tip (16; 17) in electrically conductive material and having an elongated body that forms a free end (18); a protective cap (20) , fitted onto the articulating end (15) of the electrosurgical instrument and comprising a body made of an electrically insulating material comprising:-a proximal opening (22) defined by a proximal opening edge (23) of the cap body,-at least one distal opening (24, 25) defined by at least one distal opening edge (26; 27) of the cap; wherein:-the at least one tip (16; 17) of the articulating end (15) is moveable with respect to the positioning shaft (13) and it is actuated by means of at least one actuation tendon (1 1 );- the at least one tip (16; 17) of the articulating end (15) comprises an actuation interface portion (19) for receiving the actuating action of said at least one actuation tendon (1 1 ) ;- said actuation interface portion (19) of the at least one tip (16; 17) is inside the protective cap (20) ;- said at least one actuation tendon (1 1 ) is made at least partially of polymeric material;- the body of the protective cap (20) is made of thermally insulating material; and wherein:-the free end (18) of said at least one tip (16; 17) of the articulating end (15) is exposed out of the protective cap (20);- the body of the protective cap (20) is made of a material that is impermeable to fluids and fumes;- the at least one distal opening edge (26; 27) of the protective cap (20) is fitted with mechanical interference on the elongated body of said at leastone tip (16; 17) of the electrosurgical instrument (10) , thereby resulting tight sealing adherent to the elongated body of the at least one tip (16; 17) of the electrosurgical instrument (10) , for any operating condition of the articulating end (15) .

2. Assembly according to claim 1 , wherein said articulating end (15) has a plurality of polymeric actuation tendons (1 1 ) that includes said at least one actuation tendon, each actuation tendon comprising a own distal end (12) thereof; and wherein said protective cap (20) covers the entire articulating end (15) and all the distal ends (12) of the tendons of said plurality.

3. Assembly according to claim 1 or 2, wherein said at least one distal opening edge (26; 27) of the body of the protective cap (10) is elastically stretchable, so as to be elastically preloaded against the elongated body of the at least one tip (16; 17) of the electrosurgical instrument thereby making, by means of elastic action, said mechanical interference and said tight sealing.

4. Assembly according to any one of the preceding claims, wherein the protective cap (20) is fitted onto the positioning shaft (13) of the electrosurgical instrument (10), and the proximal opening edge (23) of the cap is tight sealing adherent to said positioning shaft (13) ; and wherein, preferably, the proximal opening edge (23) is elastically stretchable so as to be elastically preloaded against the body of the positioning shaft (13) of the electrosurgical instrument (10).

5. Assembly according to any one of the preceding claims, wherein the articulating end (15) comprises two tips (16, 17) of electrically conductive material having each an elongated body forming a free end (18) ; said two tips (16, 17) including said at least one tip; said two tips being relatively movable in opening / closing (OP / CL); and wherein the at least one distal opening comprises a single distal opening (24); and wherein both said two tips (16, 17) of the electrosurgical instrument (10) are inside the protective cap (20) with each of the respective free ends (18) exposed out of said single distal opening (27).

6. Assembly according to any one of claims 1 to 4, wherein:-the articulating end (15) of the electrosurgical instrument comprises two tips (16, 17) of electrically conductive material having each an elongated body forming a free end (18) ; said two tips (16, 17) including said at least one tip; said two tips being relatively movable in opening / closing (OP / CL) ; and wherein-the protective cap (20) comprises two respective distal openings (24, 25), including said at least one distal opening, defined by two respective distal opening edges (26, 27) , that are preferably disjoined from one another; and wherein:-the free ends (18) of said two tips (16, 17) of the articulating end (15) are both exposed out of the protective cap;- the distal opening edges (26, 27) are fitted with mechanical interference onto the elongated body of the respective tips (16, 17) of the surgical instrument, thereby resulting tight sealing adherent to the elongated body of the respective tip of the electrosurgical instrument (10), for any operating condition of the articulating end (15);-between the two tips (16, 17) of the electrosurgical instrument, the protective cap (20) comprises a flap of insulating material (28) , electrically and thermally insulating and impermeable to fluids and fumes, that partially delimits both of said distal opening edges (26, 27) .

7. Assembly according to claim 6, wherein the electrosurgical instrument (10) is of the bipolar type with different electrical polarity in the two tips (16, 17).

8. Assembly according to any one of claims 1 to 5, wherein the electrosurgical instrument (10) is of the monopolar type, for example a monopolar scissor and / or monopolar dilator and / or a needle and / or a scalpel and / or a hook.

9. Assembly according to any one of the preceding claims, wherein said articulating end (15) is made of electrically conductive material, such as metal, and preferably also thermally conductive; and wherein, preferably, said articulating end (15) is made of a plurality of links of electrically conductive material including said at least one tip (16; 17) , thelinks of said plurality being mechanically connected to each other, forming an articulating kinematic chain that is electrically conductive.

10. Assembly according to any one of the preceding claims, wherein the protective cap (20) is made in single piece, i.e. , is formed by a single piece of material that is electrically and thermally insulating and impermeable to fluids and fumes.

11. Assembly according to any one of the preceding claims, wherein the proximal opening edge (23) of the protective cap (20) defines a proximal opening (22) which is bigger with respect to the at least one distal opening (24; 25) ; and wherein, preferably, the body of the protective cap (20) comprises at least one tapered portion (29) which is tapered in the distal direction, i.e. , it narrows in the distal direction; and wherein, preferably, the tapered portion (29) forms a spout of the protective cap (20) .

12. Assembly according to any one of the preceding claims, wherein the body of the protective cap (20) comprises at least one extendable portion to accommodate various operating conditions of the articulating end (15) .

13. Assembly according to claim 12, wherein said extendable portion comprises a folded portion (31 ) thereby forming a plurality of folds of material.

14. Assembly according to claim 12 or 13, wherein said extendable portion comprises an elastically stretchable portion.

15. Assembly according to any one of the preceding claims, wherein the at least one distal opening edge (26; 27) of the protective cap is made of an enlarged collar (32) .

16. Assembly according to any one of the preceding claims, wherein the body of the protective cap (20) is made of polymeric material that is biocompatible and preferably also transparent, such as rubber or plastic, for example in a silicone, i.e. , PDMS; and / or wherein the body of the protective cap (20) having thickness belonging to the range 0, 1 -0,5 millimeters, and preferably belonging to the range 0,2-0, 3 millimeters; and / or wherein the body of the protective cap (20) having Shore hardness belonging to therange 20 A - 40 A.

17. Robotic system (2) of medical or surgical teleoperation comprising at least one electrosurgical instrument and protective cap assembly (1 ) according to any one of the preceding claims.

18. Protective cap (20) for an electrosurgical instrument (10) with an articulating end (15) comprising at least one tip (16; 17), said protective cap (20) comprising a body of electrically insulating material comprising:-a proximal opening (22) defined by a proximal opening edge (23) of the cap body,-at least one distal opening (24, 25) defined by at least one distal opening edge (26; 27) of the cap; wherein:- the body of the protective cap (20) is made of thermally insulating material;- the body of the protective cap (20) is made of a material that is impermeable to fluids and fumes;- the at least one distal opening edge (26; 27) of the protective cap (20) is fitted with mechanical interference onto the elongated body of the at least one tip (16; 17) of the electrosurgical instrument (10) , thereby resulting tight sealing adherent to the elongated body of the at least one tip (16; 17) for any operating condition of the articulating end (15) .

19. Monopolar electrosurgical instrument (10) comprising:- a positioning shaft (13) having a distal portion (14) ,- an articulating end (15) coupled to the distal portion (14) of the shaft and comprising at least one tip (16; 17) in electrically conductive material having an elongated body forming a free end (18);-the at least one tip (16; 17) of the articulating end (15) is moveable with respect to the positioning shaft (13) and it is actuated by means of at least one actuation tendon (1 1 );- said at least one actuation tendon (1 1 ) is made at least partially of polymeric material; wherein: the positioning shaft (13) and the articulating end (15) with said at least one tip (16; 17) are made of electrically conductive material, thereby makingelectrical continuity from the positioning shaft (13) to the free end (18) of the at least one tip (16; 17) of the articulating end, avoiding providing a separate electrical conductor that is terminated on the at least one tip (16; 17).

20. Monopolar electrosurgical instrument according to claim 19, wherein the articulating end (15) comprises a support link (35) between the positioning shaft and the at least one tip; said support link (35) forming together with said at least one tip a rotational pin joint comprising a joint pin (37) made of electrically conductive material; and wherein, preferably, the rotational pin joint is made by said support link (35) that is intimately in contact with said at least one tip (16; 17) to maximize the contact surface therebetween, and / or wherein the support link (35) defines in a single piece two rotational pin joints with mutually orthogonal axis.

21. Monopolar electrosurgical instrument according to claim 19 or 20, wherein the positioning shaft (13) is integral in roll rotation with the articulating end (15) around a rotation axis of roll (R-R) substantially coinciding with the longitudinal extension axis of the positioning shaft.

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