Active electrosurgical instruments and protective caps for remote operation in medical or surgical applications, and related robotic systems.

Abstract

An electrosurgical instrument (10) comprising a positioning shaft (13) having a distal portion (14), and an articular end (15) connected to the distal portion (14) of the shaft and having an elongated body forming a free end (18) and having at least one tip portion (16;17) made of an electrically conductive material, and attached to the articular end (15) of the electrosurgical instrument, a proximal opening (22) defined by the proximal opening edge (23) of the cap body, and at least one distal opening edge (26;27) of the cap An assembly (1) comprising a protective cap (20) having a body made of an electrically insulating material, including one distal opening (24;25), wherein at least one end portion (16;17) of the articular end (15) is movable relative to a positioning shaft (13) and is actuated by at least one actuating tendon (11), and at least one end portion (16;17) of the articular end (15) has an actuating interface portion (19) for receiving the actuating action of at least one actuating tendon (11), Assembly (1), wherein the operating interface portion (19) of at least one tip (16;17) is located inside a protective cap (20), at least one operating tendon (11) is formed at least in part from a polymer material, the body of the protective cap (20) is formed from a thermally insulating material, the free end (18) of at least one tip (16;17) of the articular end (15) is exposed to the outside of the protective cap (20), the body of the protective cap (20) is formed from a material that is impermeable to fluids and smoke, and at least one distal opening edge (26;27) of the protective cap (20) is fitted with mechanical interference to the elongated body of at least one tip (16;17) of the electrosurgical instrument (10), thereby providing a tightly sealed state to the elongated body of at least one tip (16;17) of the electrosurgical instrument (10) in any operating configuration of the articular end (15).

Description

Technical Field

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

[0002] In particular, the present invention relates to an assembly comprising an electrosurgical instrument and a protective cap.

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

[0004] The present invention further relates to a protective cap.

[0005] In addition, the present invention further relates to an electrosurgical instrument.

Background Art

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

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

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

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

[0010] In fact, in the field of robotic surgery, surgical instruments are components intended to operate in a sterile environment, and typically a sterile barrier is interposed between the "backend" part of the instrument and the corresponding part of the operating interface. As a result, the robotic manipulator is placed in the non-sterile area of ​​the surgical setup. Therefore, the motor is usually located in the manipulator, i.e., on the non-sterile side, and the surgical instrument itself lacks a motor.

[0011] For example, US-10582975 and WO-2018-189721 by the same applicant disclose various embodiments of surgical instruments for robotic and microsurgical procedures, which feature very small articulated cuffs, and consequently, operating ends or end effectors, with the links forming the end effectors being manufactured by wire electrical discharge machining.

[0012] Using metal tendons, such as tungsten strands, allows for a degree of predictability regarding the applied action because their length does not change significantly under load. However, these types of metal tendons are typically relatively large in diameter, requiring dedicated guide channels or grooves on the end effector components they contact, thus imposing large dimensions on the end effector components. In practice, an idler pulley rotatably mounted on the articulated end effector link is usually provided to guide the metal tendon along its path, and a fixed pulley, keyed to the end effector link, determines the operation of the end effector joint under the tensile force applied by the metal tendon. Therefore, the use of metal tendons hinders further miniaturization of end effectors.

[0013] For example, as shown in prior art document US-2021-106393 by the same applicant, it is also known that the working tendon can be made of polymer material to reduce the dimensions of the articulated cuff and the coefficient of sliding friction between the tendon and the articulated cuff. In fact, by providing a polymer-fabricated working tendon, it becomes possible to utilize a different operating principle based on the polymer tendon sliding on a dedicated sliding surface of the end effector link that lacks a guide channel. This reduces the sliding contact area (in cross-section) between the tendon and the link, thereby reducing the local force acting on the tendon, and as a result, it becomes possible to use a smaller diameter tendon, although it may be more fragile. Furthermore, it is possible to reduce the size of the end effector link because there is no need to excavate a guide channel for the tendon.

[0014] However, polymer tendons are prone to irreversible stretching during use (e.g., plastic elongation and / or stretching due to unraveling and readjustment of braided fibers), and this drawback becomes even more pronounced with further miniaturization. That is, as the size of an articulated cuff formed from surgical steel and actuated by a tendon decreases, it becomes clear that each longitudinal shortening or elongation of the tendon drives the corresponding angular movement of the cuff, and the magnitude of that angular movement gradually increases.

[0015] Therefore, the provision of such polymer tendons may require a dedicated control algorithm that can be used to avoid irreversible stretching of the tendon itself during use, as shown, for example, in WO-2022-264078, WO-2022-264075, WO-2022-264080, and WO-2023-047300 by the same applicant. For example, in master-slave remote operation, a preloading cycle can be performed on all braided polymer tendons before the robotic system enables remote operation in order to avoid, or at least minimize, the occurrence of irreversible stretching of the polymer tendon.

[0016] Surgical instruments adapted to transmit electricity to tissue, such as electrocautery instruments for robotic surgery, are also known. Some known examples of such instruments are shown in prior art documents US-6840938, US-7824401, US-10376331, US-8398634, US-10716617, and US-2022-133388.

[0017] Known electrosurgical instruments typically include one or more conductors for transmitting electricity from a robotic manipulator to the articular end of the instrument's end effector via a transmission interface of the surgical instrument.

[0018] Such articulated electrosurgical instruments are typically made from electrically non-conductive materials, preferably composed of an insulator such as a highly thermally stable non-conductive plastic (e.g., ULTEM) or ceramic, with the exception of conductive metal ends to which the electrical conductive cables are terminated.

[0019] If all the joint components of the end effector, as well as the idler or fixed pulley, and the motion-actuating strands made of steel or tungsten, are made of metal, there is a risk of insufficient electrical insulation, and voltage may be transmitted backward through the actuating cable to the entire joint end and even to the proximal transmission interface ("backend"). For this reason, the active joint ends of known electrosurgical devices of this type are usually quite large and not suitable for miniaturization.

[0020] To electrically insulate the joint ends of such active electrosurgical instruments, an insulating sleeve is typically fitted around the entire end effector, thereby creating an electrically insulated barrier from the end effector itself or from the patient's tissues that come into contact with it.

[0021] In particular, in known electrocautery applications in laparoscopic surgery, it is crucial to avoid the transmission of electricity at the fulcrum, i.e., the position where the surgical instrument is inserted into a dedicated insertion port. The fulcrum constitutes the center of rotation of the positioning rod or shaft relative to the patient under operating conditions. For this reason, the positioning shaft itself is formed from an electrically insulating material or covered with an insulating layer (e.g., rubber).

[0022] Such articulated electrosurgical instruments, particularly in endoscopic or minimally invasive applications, feature a hollow positioning shaft made of electrically non-conductive plastic or composite material to avoid unwanted lateral discharge. Only electrically conductive cables extending within a specific channel inside the shaft transmit potential, supplying it to a metal application terminal (e.g., a "jaw") to which the conductive cables are connected.

[0023] In fact, monopolar electrosurgical instruments typically have an electrical cable running through the positioning rod or shaft of the instrument, extending from the transmission interface ("backend") to the articulated cuff. The positioning shaft is usually made of an electrically insulating material, while the working end of the electrosurgical instrument is made of an electrically active metal. In such known monopolar electrosurgical instruments, the electrical circuit is closed by a return electrode (usually a plate) after it has passed through a part of the patient's body.

[0024] On the other hand, in bipolar electrosurgical instruments, the two tips of the instrument are polarized with different charges, forming two electrodes, one of which forms the return electrode. In this type of electrosurgical instrument, it is necessary to avoid short circuits between various parts of the end effector that have different electrical charges (for example, the two tips themselves, and between their respective electrical conductors).

[0025] Furthermore, it is known that electrically insulating sleeves are used attached to articulated cuffs to prevent involuntary electrical supply from areas other than the terminal (in both monopolar and bipolar devices).

[0026] While known solutions offer some advantages in certain respects, the challenge of providing adequate and effective protection from the risks associated with electrosurgical movements, while aiming to facilitate the extreme miniaturization of articulated end-effectors, remains unresolved. [Overview of the Initiative]

[0027] (Solution means) The object of the present invention is to eliminate the drawbacks of the above-described prior art and propose a solution to the above-described needs.

[0028] These and other objects are achieved by the assembly according to claim 1, the protective cap according to claim 18, and the electrosurgical instrument according to claim 19.

[0029] Some advantageous embodiments are the subject of the dependent claims.

[0030] According to one aspect of the present invention, an assembly of an electrosurgical instrument and a protective cap includes an electrosurgical instrument and a protective cap.

[0031] The electrosurgical instrument includes a positioning shaft having a distal portion, and an articulating end portion including at least one tip formed of an electrically conductive material having an elongated body connected to the distal portion of the positioning shaft and forming a free end.

[0032] The protective cap is attached to the articulating end portion of the electrosurgical instrument and includes a body made of an electrically and thermally insulating material, a proximal opening defined by a proximal opening edge of the cap body, and at least one distal opening defined by at least one distal opening edge of the cap.

[0033] At least one tip of the articulating end portion is movable relative to the positioning shaft and is actuated by at least one polymeric actuating tendon. At least one tip of the articulating end portion includes an actuating interface portion for receiving the actuating action of at least one actuating tendon. The actuating interface portion of at least one tip is disposed inside the protective cap, and the free end of at least one tip of the articulating end portion is exposed outside the protective cap.

[0034] The body of the protective cap is formed from a material that is impermeable to fluids and smoke, and at least one distal opening edge of the protective cap is fitted with mechanical interference to the elongated body of at least one tip of the electrosurgical instrument, thereby providing a tightly sealed state to the elongated body of at least one tip of the electrosurgical instrument in any movement configuration of the articular end.

[0035] The articular end may have multiple polymer-made articular tendons, each containing at least one articular tendon, each having an articular distal end, and the protective cap covers the entire articular end and all articular distal ends of the multiple articular tendons.

[0036] Preferably, the protective cap covers all the rotary joints at the joint ends.

[0037] At least one distal opening edge of the protective cap body is elastically stretchable, thereby elastically preloading the elongated body of at least one tip of the electrosurgical instrument, and the elastic action creates mechanical interference and a sealed state.

[0038] The electrosurgical instrument may be monopolar. According to one embodiment, the articular end comprises two tips made of an electrically conductive material, each having an elongated body that forms a free end, the two tips including at least one tip, the two tips being relatively movable in an opening and closing direction, at least one distal opening including a single distal opening, and both of the two tips of the electrosurgical instrument being located inside a protective cap, with each free end exposed to the outside of the single distal opening.

[0039] The electrosurgical instrument may be bipolar. According to one embodiment, the articular end of the electrosurgical instrument comprises two tips made of an electrically conductive material, each having an elongated body that forms a free end, the two tips include at least one tip, and the two tips are relatively movable in the opening and closing direction, the protective cap comprises two distal openings, each containing at least one distal opening, each of the two distal openings is defined by two distal opening edges, preferably separated from each other, both free ends of the two tips of the articular end are exposed to the outside of the protective cap, the distal opening edges are fitted with mechanical interference to the elongated body of each tip of the surgical instrument, thereby providing a tightly sealed state to the elongated body of each tip of the electrosurgical instrument in any operating configuration of the articular end, the protective cap comprises a flap made of an insulating material that is electrically and thermally insulating and impermeable to fluids and smoke, the flap partially defining both distal opening edges.

[0040] According to one aspect of the present invention, a protective cap for an electrosurgical instrument having an articular end with at least one tip comprises a body made of an electrically insulating material, and includes a proximal opening defined by a proximal opening edge of the cap body and at least one distal opening defined by at least one distal opening edge of the cap, wherein the body of the protective cap is formed of a thermally insulating material, the body of the protective cap is formed of a material that is impermeable to fluids and smoke, and at least one distal opening edge of the protective cap is fitted to the elongated body of at least one tip of the electrosurgical instrument by mechanical interference, thereby providing a tightly sealed state to the elongated body of at least one tip in any operating configuration of the articular end.

[0041] According to one aspect of the present invention, a monopolar electrosurgical instrument includes a positioning shaft having a distal portion and an articular end having at least one tip made of an electrically conductive material and connected to the distal portion of the shaft, the tip of which is movable relative to the positioning shaft and actuated by at least one actuating tendon, the at least one actuating tendon being at least partly made of a polymer material. The positioning shaft and the articular end having at least one tip are made of an electrically conductive material, thereby ensuring electrical continuity from the positioning shaft to the free end of at least one tip of the articular end, and avoiding the need to provide a separate electrical conductor terminated at at least one tip.

[0042] According to the proposed solution, the polymer-based articular tendon at the joint end is protected by a protective cap.

[0043] Damage to polymer-fabricated tendons can occur as a result of heating of the polymer-fabricated tendon itself due to contact with fluids, vapors, and fumes generated by the use of electrosurgical instruments. In fact, when the local temperature of a polymer-fabricated tendon exceeds 80°C to 90°C, the polymer material constituting the tendon can melt, while such vapors and fumes can exceed 100°C (water vapor).

[0044] Damage to polymer-based articular tendons can also occur when the articular tendon itself absorbs moisture from fluids, vapors, and smoke, which increases the electrical conductivity of the articular tendon and, as a result, generates excessive heat due to the Joule effect.

[0045] According to the proposed solution, it is possible to prevent fluids, vapors, and fumes that could directly affect and damage the polymeric articular tendons at the joint ends from entering the inside of the protective cap during electrosurgical intervention.

[0046] Therefore, this enables an extremely miniaturized articular end of the electrosurgical instrument, while allowing for accurate, reliable, and repeatable supply of electricity without reducing the operating life of the electrosurgical instrument itself.

[0047] Further features and advantages of the present invention will become apparent from the following description of preferred embodiments shown as non-limiting examples, with reference to the accompanying drawings which are briefly described below. It should be understood that references to “certain” embodiments in this specification do not necessarily refer to the same embodiment, but rather to at least one embodiment. Furthermore, for reasons of brevity and to reduce the total number of drawings, some figures may be used to illustrate features of multiple embodiments, and not all elements in the figures are necessarily required for a particular embodiment. [Brief explanation of the drawing]

[0048] [Figure 1] Figure 1 is a schematic diagram showing an assembly of an electrosurgical instrument and a protective cap according to an embodiment in which the electrosurgical instrument is of the monopolar type. [Figure 2] Figure 2 is an axial projection view of the joint end and protective cap of an electrosurgical instrument according to an embodiment. [Figure 3A] Figure 3A is a plan view of the joint end of an electrosurgical instrument according to an embodiment. [Figure 3B] Figure 3B is a plan view of the joint end of an electrosurgical instrument according to an embodiment, created based on the viewpoint indicated by arrow B in Figure 3A, and some parts have been omitted for clarity. [Figure 4A] Figure 4A is a diagram showing an assembly of an electrosurgical instrument and a protective cap according to an embodiment, with the protective cap shown in cross-section. [Figure 4B] Figure 4B shows the protective cap in the assembly shown in Figure 4A. [Figure 4C] Figure 4C shows some of the operational configurations of the articular end of the electrosurgical instrument in the assembly shown in Figure 4A. [Figure 4D]Figure 4D shows some of the operational configurations of the articular end of the electrosurgical instrument in the assembly shown in Figure 4A. [Figure 4E] Figure 4E is a view from the viewpoint indicated by arrow E in Figure 4A. [Figure 5A] Figure 5A shows an assembly of an electrosurgical instrument and a protective cap, according to an embodiment in which the protective cap is shown in cross-section. [Figure 5B] Figure 5B shows the protective cap in the assembly shown in Figure 5A. [Figure 5C] Figure 5C shows some of the operational configurations of the articular end of the electrosurgical instrument in the assembly shown in Figure 5A. [Figure 5D] Figure 5D shows some of the operational configurations of the articular end of the electrosurgical instrument in the assembly shown in Figure 5A. [Figure 5E] Figure 5E is a view from the viewpoint indicated by arrow E in Figure 5A. [Figure 6A] Figure 6A shows an assembly of an electrosurgical instrument and a protective cap, according to an embodiment in which the protective cap is shown in cross-section. [Figure 6B] Figure 6B shows the protective cap in the assembly shown in Figure 6A. [Figure 6C] Figure 6C shows some of the operational configurations of the articular end of the electrosurgical instrument in the assembly shown in Figure 6A. [Figure 6D] Figure 6D shows some of the operational configurations of the articular end of the electrosurgical instrument in the assembly shown in Figure 6A. [Figure 6E] Figure 6E is a view from the viewpoint indicated by arrow E in Figure 6A. [Figure 7A] Figure 7A shows an assembly of an electrosurgical instrument and a protective cap, according to an embodiment in which the protective cap is shown in cross-section. [Figure 7B] Figure 7B shows the protective cap in the assembly shown in Figure 7A. [Figure 7C]Figure 7C shows one of the operational configurations of the articular end of an electrosurgical instrument in the assembly shown in Figure 7A. [Figure 7D] Figure 7D is a view from the viewpoint indicated by arrow D in Figure 7A. [Figure 8A] Figure 8A shows an assembly of an electrosurgical instrument and a protective cap, according to an embodiment in which the protective cap is shown in cross-section. [Figure 8B] Figure 8B shows the protective cap in the assembly shown in Figure 8A. [Figure 8C] Figure 8C shows one of the operational configurations of the articular end of an electrosurgical instrument in the assembly shown in Figure 8A. [Figure 8D] Figure 8D is a view from the viewpoint indicated by arrow D in Figure 8A. [Figure 8E] Figure 8E shows one of the operational configurations of the articular end of an electrosurgical instrument in the assembly shown in Figure 8A. [Figure 8F] Figure 8F is a view from the viewpoint indicated by arrow F in Figure 8E. [Figure 8G] Figure 8E is a view from the same perspective as in Figure 8F, showing an electrosurgical instrument equipped with surgical scissors. [Figure 9] Figure 9 is a schematic diagram showing an assembly of an electrosurgical instrument and a protective cap in an embodiment in which the electrosurgical instrument is of the monopolar type. [Figure 10A] Figure 10A is a schematic axial projection view showing an assembly of an electrosurgical instrument and protective cap according to an embodiment. [Figure 10B] Figure 10B shows the protective cap in the assembly shown in Figure 10A. [Figure 10C] Figure 10C is a view of the assembly in Figure 10A, seen from the viewpoint indicated by arrow C in Figure 10A. [Figure 11A] Figure 11A shows a schematic axial projection view of an assembly of an electrosurgical instrument and protective cap according to an embodiment. [Figure 11B]Figure 11B is a diagram showing a portion of the assembly in Figure 11A, with the protective cap shown in cross-section. [Figure 11C] Figure 11C is a schematic diagram showing an assembly of an electrosurgical instrument and a protective cap according to an embodiment, with the protective cap shown in cross-section. [Figure 11D] Figure 11D is a schematic diagram showing an assembly of an electrosurgical instrument and a protective cap according to an embodiment, with the protective cap shown in cross-section. [Figure 12] Figure 12 is a diagram showing a part of the assembly according to the embodiment, with the protective cap shown in cross-section. [Figure 13A] Figure 13A is a three-dimensional front view showing a part of the assembly according to the embodiment. [Figure 13B] Figure 13B is a view from the viewpoint indicated by arrow B in Figure 13A. [Figure 14A] Figure 14A shows some possible steps of the manufacturing method according to the embodiment. [Figure 14B] Figure 14B shows some possible steps of the manufacturing method according to the embodiment. [Figure 15] Figure 15 shows a cross-section of a mold for manufacturing a protective cap according to the embodiment. [Figure 16] Figure 16 shows a perspective view of a remotely operated robot system for medical or surgical use, comprising an assembly, according to an embodiment. [Modes for carrying out the invention]

[0049] Throughout this specification, any reference to “a particular embodiment” means that a specific feature, structure, or function described in relation to that embodiment is included in at least one embodiment of the present invention. Therefore, the phrase “in one embodiment” throughout this specification does not necessarily refer to the same embodiment. Furthermore, specific features, structures, or functions, as shown in different drawings, can be combined in any suitable manner in one or more embodiments.

[0050] According to a general embodiment, an assembly 1 (or assembly 1) of an electrosurgical instrument and protective cap is provided, which comprises an electrosurgical instrument 10 (or instrument 10) and a protective cap 20.

[0051] The electrosurgical instrument 10 is an active instrument 10 adapted to supply energy to the patient, such as an electrocautery device.

[0052] The electrosurgical instrument 10 comprises a positioning shaft 13 having a distal portion 14, and an articular end 15 that is operatively connected to the distal portion 14 of the rod.

[0053] The articular end 15 preferably includes an articulated cuff that defines two orthogonal axes of motion (e.g., pitch PP and yaw YY).

[0054] The joint end 15 may include, for example, a vertebral structure (snake) of the type used in flexible robotics. The positioning shaft 13 may also include a vertebral structure.

[0055] In a preferred embodiment, the positioning shaft 13 is rigid. The positioning rod or shaft 13 preferably has an elongated body that is hollow inside, and within that, for example, within the cavity of the elongated body of the positioning rod or shaft, the actuari tendons 11 (for example, three pairs of actuari tendons that act antagonistically to each of the three links at the joint end) extend.

[0056] The instrument 10 preferably further comprises a proximal transmission interface 34 ("backend") for connecting to each transmission interface 2 of the robotic system for surgical remote control. The transmission interface 34 is preferably located at the opposite end of the positioning shaft, i.e., the proximal end of the shaft.

[0057] The articular end 15 of the instrument 10 comprises at least one tip 16, 17 (or tip link 16, 17). At least one tip 16, 17 is formed of an electrically conductive material and has an elongated body that forms at least one free end 18. The free end 18 of the tip 16 or 17 can be used to supply energy to the electrosurgical instrument 10 under operating conditions, although the energy may also be supplied by other body portions of the tip 16, 17 of the articular end 15, such as the gripping surface or cutting surface of the tip.

[0058] At least one end portion 16;17 of the articular end 15 is movable relative to the positioning shaft 13 and is actuated by at least one actuating tendon 11. In other words, the articular end 15 has at least one degree of freedom actuated by at least one actuating tendon 11, which moves at least one end portion 16,17 relative to the positioning shaft 13. In particular, at least one end portion 16;17 of the articular end 15 is provided with an actuating interface portion 19 for receiving actuation by at least one actuating tendon 11.

[0059] Of course, at least one of the tip portions 16, 17 is preferably formed integrally as a single block made of an electrically conductive material, and therefore the actuation interface portion 19 of the tip portions 16, 17 may include a terminal seat or groove 19 having an undercut wall that cooperates with the expanded distal portion 12 of the actuation tendon 11 to allow the actuation tendon 11 to move the tip portions 16, 17.

[0060] The actuation interface seat 19 is preferably positioned on the opposite side of the free end 18 of the tip portion with respect to the longitudinal extension of the body of the tip portions 16 and 17. The actuation interface portion 19 is preferably provided near the mounting base 38 of the tip link, i.e., near the articulation pin 37 of the rotary joint of the motion of the tip link 16 or 17. The actuation tendon 11 is preferably wrapped around the cylindrical surface (a type of fixed pulley made of a single member) of the mounting base 38 of the tip link and terminated at the actuation interface seat 19 of the tip link.

[0061] According to one embodiment, at least one tip portion 16, 17 is manufactured by wire electrical discharge machining (WEDM, or spark erosion) using a workpiece made of an electrically conductive material, such as surgical steel, or metal, as the starting material.

[0062] In one embodiment, the articular end 15 of the surgical instrument comprises two tips 16, 17 made of an electrically conductive material, each having an elongated body that forms a free end 18 (the two tips 16, 17 include at least one of the aforementioned tips). In this case, the electrosurgical instrument 10 may be monopolar or bipolar, as described below. If two tips 16, 17 are included, each may be provided with at least one actuating tendon 11, preferably a pair of opposing actuating tendons. If two tips 16, 17 are included, the tips may function as jaws, i.e., they may be movable relative to each other in the opening / closing (OP / CL) direction.

[0063] The articulated end 15 may include a support link 35 in addition to at least one toe portion 16, 17, the support link 35 preferably articulated with at least one toe portion 16, 17 by a rotary joint, thereby constraining at least one toe portion 16, 17 to rotate relative to the support link 35 about the axis of rotation of yaw YY (e.g., the axis of rotation of yaw YY). The support link 35 may include one or more claw portions 36 defining a through seat that receives an articulated pin 37 and also receives a portion of the mounting root 38 of at least one toe portion 16, 17, thereby forming a rotary joint having the axis of rotation of yaw YY. Further proximal links 41 articulated with the support link 35 may also be included. The axis of rotation of the pitch PP of the rotary joint between the support link 35 and the proximal links is preferably perpendicular to the axis of rotation of yaw YY.

[0064] At least one actuarial tendon 11 for moving the tip portions 16 and 17 relative to the positioning shaft 13 is formed at least in part from a polymer material. Preferably, at least one actuarial tendon 11 is formed solely from a polymer material. Therefore, at least one actuarial tendon 11 is not suitable for functioning as an electrical conductor and is therefore unsuitable for supplying power to at least one tip portion 16 and 17 of the articular end 15 of the electrosurgical instrument 10.

[0065] At least one working tendon 11 may be a braided polymer tendon in which multiple polymer fibers are braided together. The polymer fibers may be made of ultra-high molecular weight polyethylene (UHMWPE). The working tendon 11 may include a covering portion made of braided polymer fibers and a core portion disposed inside the covering portion, the core portion may also be made of braided polymer fibers.

[0066] The electrosurgical instrument 10 further comprises at least one electrical conductor connected to at least one tip 16, 17 for supplying power to the tip 16, 17 during operation. For example, the electrical conductor may include an electrical cable terminated to an electrically conductive body of at least one tip 16, 17, with the other end connected to an electrical generator 39. For example, the electrical conductor may also include at least a portion of a positioning shaft 13 (or positioning rod) which may be formed from an electrically conductive material. The positioning rod or shaft 13 may be covered with a sheath made of an electrically insulating material such as a sheath 47, and the proximal opening edge 23 of the protective cap 20 may be tightly joined to the sheath 47. For example, the positioning shaft 13 may include a conductor located inside the body of an electrically insulating positioning rod or shaft.

[0067] In a preferred embodiment, both the positioning shaft 13 and the articular end 15 are formed from an electrically conductive material and form an electrical conduction path for supplying power to at least one tip 16, 17 of the electrosurgical instrument 10, which is electrically connected to the electric generator 39. Preferably, the support link 35 and, if provided, the proximal link 41 are formed from an electrically conductive material. The articular pin 37 may also be formed from an electrically conductive material.

[0068] By forming at least one actuarial tendon 11 from a polymer material, very low sliding friction of the actuarial tendon 11 is possible on a dedicated sliding surface 40 for the actuarial tendon 11 provided on the body of the articular end 15 of the electrosurgical instrument 10. The sliding surface is preferably a convex ribbed surface having generatrix parallel to the axis of rotation of pitch PP or yaw YY, which is well known. The body of the support link 35 preferably has one or more sliding surfaces 40 for at least one actuarial tendon 11 for moving at least one tip 16, 17, which is also well known. At least one actuarial tendon 11 slides on one or more sliding surfaces 40 when pulled to move the tip 16 around the axis of rotation YY. For example, as shown in Figure 2, the tip 16 may have two opposite seats 19 that receive the actuarial tendons 11 of a pair of actuarial tendons, each having an antagonistic effect. The convex and ribbed sliding surface 40 may include a surface facing the centerline of the joint end 15. For example, the support link 35 may have multiple convex ribbed sliding surfaces, one of which is generated by a line parallel to the pitch axis PP, and another ribbed sliding surface is generated by a line parallel to the yaw axis YY which is perpendicular to the pitch axis.

[0069] To actuate the support link 35, one or more tendons 45 may be provided, the tendons 45 terminating on the support link and sliding on a dedicated sliding surface of the proximal link 41. The proximal link 41 may be fixed to the positioning shaft 13 and may form the distal portion 14 of the shaft itself. The proximal link 41 may have at least one sliding surface for at least one actuating tendon 11 or 45 for moving at least one end link 16, 17 or the support link 35.

[0070] As described above, the assembly 10 further comprises a protective cap 20. Preferably, the protective cap 20 is attached to the articular end 15 of the electrosurgical instrument 10 and comprises a body made of an electrically insulating material. In other words, the body of the protective cap 20 has electrical insulating properties, while at least one of the tip portions 16, 17 is formed of an electrically conductive material.

[0071] For example, before initiating an electrosurgical intervention involving the use of the electrosurgical instrument 10, the protective cap 20 is fitted onto the joint end 15 in a sock-like manner, thereby exposing at least one tip portion 16, 17 that forms at least one actively exposed portion of the electrosurgical instrument 10.

[0072] 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 may be mounted on the positioning shaft 13, and at least one distal opening edge 26, 27 may be mounted on at least one tip portion 16, 17.

[0073] As a further advantage, the actuation interface portion 19 of at least one tip portion 16, 17 that receives at least one actuation tendon 11 made of polymer material is located inside the protective cap 20. Thus, the protective cap 20 also functions as a protective device for the distal portion 12 of at least one actuation tendon 11, including an extended distal portion that forms a knot for exerting a tensile force on the tip link.

[0074] In particular, the body of the protective cap 20 is formed from a material that is impermeable to fluids and smoke (in this specification, “fluid” means both gases and vapors, and further, smoke released by, for example, electrocautery, as well as mixtures thereof and liquids). In other words, the body of the protective cap 20 is formed from a material that is electrically insulating and impermeable to fluids, vapors, and smoke.

[0075] The impermeability of the protective cap 20 protects the working tendon 11 from becoming wet, that is, it prevents fluids such as biological fluids, gases, and vapors, in addition to smoke resulting from the electrocautery action applied by at least one tip 16, 17 of the articular end 15 of the electrosurgical instrument 10, from penetrating the polymer-made articular tendon 11.

[0076] The protective cap 20 protects the polymer-fabricated articulated tendon 11 from excessive overheating that may occur due to direct exposure of the articulated tendon 11 to fluids, vapors, and smoke resulting from electrocautery.

[0077] As a further advantage, at least one distal opening edge 26, 27 of the protective cap 20 is attached to the elongated body of at least one tip 16, 17 of the surgical instrument 10 by mechanical interference, thereby achieving a tight seal on the elongated body of at least one tip 16, 17 of the electrosurgical instrument 10. Preferably, the tight seal of the distal opening edge of the cap occurs in the intermediate portion between the mounting base 38 and the free end 18 of the tip, i.e., approximately half of the tip.

[0078] Mechanical interference occurs as a result of the body of the protective cap 20 being stretched by the body of at least one of the tip portions 16, 17 of the articular end 15 of the instrument 10.

[0079] In a preferred embodiment, the body of the protective cap 20 is formed from a thermally insulating material. This allows the body of the protective cap 20 itself to form a sealing barrier around the conductive tip portions 16 and 17 of the joint end, as well as to protect the working tendon 10 from excessive overheating that could degrade the performance of the working tendon 10.

[0080] At least one of the tip portions 16, 17 may have a tapered shape (e.g., including a tapered portion 29) that narrows toward the distal end 18, thereby facilitating the stretching of the protective cap due to mechanical interference when the protective cap is attached to at least one of the tip portions 16, 17. The tapered portion may form a spout. The tapered portion may form an inclination of 10° to 30° with respect to the definable longitudinal direction of the cap and the articular end.

[0081] Expansion of at least one distal opening edge 26;27 due to mechanical interference may be caused by plastic stretching of the body of the protective cap 20.

[0082] In one embodiment, at least one tip portion 16, 17 has a square cross-section, and the opening edge 26, 27 of at least one distal opening 24, 25 has a substantially circular shape in a stationary state and is stretched by mechanical interference of the tapered wall of the body of at least one tip portion 16, 17 of the articulated end 15 during the operation of attaching the cap 20 to the tip portion 15. Preferably, at least one tip portion 16 comprises a body having a square cross-section with two pairs of substantially flat surfaces 42, 43 facing each other, where each surface 42, 43 forms an edge with respect to each other, and each surface 42, 43 has a trapezoidal or triangular cross-section, formed so that the edges 44 converge, forming a tapered tip portion 16. If two tip portions 16, 17 are provided that are movable in the opening / closing (OP / CL) direction, each surface 43 may function as a contact surface between the two tip portions, such as a gripping surface and / or cutting surface, or other type of working surface.

[0083] To attach the protective cap 20 to the joint end 15, preferably, the joint end 15 is first prepared in a state where it is fully assembled to the positioning shaft 13, and then at least one tip is inserted from the proximal opening 22 into the cavity 21 formed inside the body of the cap 20.

[0084] At least one distal opening 26, 27 of the protective cap 20 may be formed by perforating the body of the protective cap 20 with at least one tip 16, 17 of the articular end 15. In other words, the protective cap 20 may be manufactured without at least one distal opening 26, 27 and then perforated by at least one tip of an electrosurgical instrument.

[0085] The airtight seal is maintained in any operating configuration of the joint end 15. This ensures that the protective cap 20 is sealed, regardless of the orientation of at least one of the end portions 16, 17 relative to the positioning shaft 13, preventing steam and smoke from entering the cavity 21 of the cap. For example, such a protective cap 20 maintains an airtight seal in any operating configuration of the kinematic chain (rotary joint PP and YY) of the joint end 15, and in both the state with and without energy supply.

[0086] When the polymer material of tendons is exposed to the above-mentioned fluids under operating conditions, it may undergo premature and undesirable degradation, potentially leading to a decrease in mechanical properties (plastic elongation and / or localized melting of the polymer material) or a decrease in electrical properties (electrical conduction through the tendon itself).

[0087] The provision of the protective cap 20 makes it possible to avoid, or at least minimize, the risk of the polymer-fabricated articular tendon 11, which is designed to apply a mechanical tensile action for the purpose of moving at least one end portion 16, 17 of the articular end 15, becoming wet with fluid products and smoke during electrosurgery or microsurgical intervention, as well as the risk of excessive overheating that leads to deterioration of the mechanical properties (plasticity) of the polymer-fabricated tendon itself.

[0088] According to one embodiment, at least one distal opening edge 26, 27 of the body of the protective cap 10 is elastically stretchable, thereby elastically preloading the elongated body of at least one tip 16, 17 of the electrosurgical instrument, and the elastic action creates mechanical interference and a sealing state. The elastic action acting on the body of at least one tip 16, 17 by the distal opening edge 26, 27 of the protective cap 20 defines the sealing state.

[0089] In a preferred embodiment, if the articular end 15 has a plurality of polymer-made articulated tendons 11, 45, each including at least one articulated tendon, and each articulated tendon has an articulated distal end 12 (e.g., at least one tip link 16 and / or 17, and / or an articulated distal end for acting on a support link 35), the protective cap 20 covers the entire articular end 15 and all articulated distal ends 12 of the plurality of articulated tendons. This provides adequate protection for all articulated tendons 11, 45 by the use of the protective cap 20. Preferably, all rotary joints of the articular end 15 are located inside the protective cap 20.

[0090] In a preferred embodiment, the protective cap 20 is fitted onto the positioning shaft 13 of the surgical instrument 10, and the proximal opening edge 23 of the cap forms a tight seal with the positioning shaft 13, for example, at the distal portion 14 of the shaft. This seal provided by the proximal end 23 of the protective cap 20 further enhances the protection provided to the working tendon 11. For this purpose, the proximal opening edge 23 may be formed to be 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, and its distal portion 14, may have a substantially cylindrical shape.

[0091] The protective cap 20 is preferably integrally molded.

[0092] According to one embodiment, for example as shown in Figures 4A to 4E, the body of the protective cap 20 comprises a single distal opening 26 having a diameter smaller than the proximal opening 22 and a tapered portion 29 (i.e., tapering between them), and the instrument 10 comprises a single tip 16 (in this case, the instrument is a monopolar electrosurgical instrument). By inserting the tip 16 into the distal opening 24, the distal opening edge 26 is extended.

[0093] The proximal opening edge 23 may be formed by an expansion portion, such as an expanded collar portion 32, to improve the grip and sealing of the instrument 10 with respect to the positioning shaft 13.

[0094] According to one embodiment, for example as shown in Figures 5A to 5E, the body of the protective cap 20 is provided with a tapered portion 29, and the distal opening edge 26 is formed to be elongated and tapered in order to increase the contact area between the tip 16 of the articular end 15 and the body (in this case, the instrument is a monopolar electrosurgical instrument).

[0095] According to one embodiment, as shown in Figures 6A to 6E, for example, the body of the protective cap 20 is equipped with a foldable extendable portion 31 that includes a plurality of material folding portions, thereby enabling it to accommodate various operating configurations of the joint end 15 (in this case, the instrument is a monopolar electrosurgical instrument). Under operating conditions, the provision of material folding portions ensures that there is enough material to avoid, or at least reduce, the risk of dragging on at least one of the tip portions 16, 17 due to the stretching resistance of the cap 20.

[0096] According to one embodiment, for example, as shown in Figures 7A to 7D, the body of the protective cap 20 forms an extended collar portion at the distal opening edge 26, thereby contributing to achieving a sealed state (in this case, the instrument is a monopolar electrosurgical instrument).

[0097] If the electrosurgical instrument 10 is monopolar, it may be, for example, a needle and / or a scalpel and / or a hook. The electrosurgical instrument 10 may be monopolar and have two tips 16, 17, for example, a monopolar scissors (Figure 8G) and / or a monopolar expander (Figure 8D).

[0098] According to one embodiment, the articular end 15 of the electrosurgical instrument 10 comprises two end portions 16, 17 made of an electrically conductive material, each having an elongated body that forms a free end 18, the two end portions including at least one other end portion, and the two end portions are movable relative to each other in the opening / closing (OP / CL) direction. For example, the two end portions 16, 17 are constrained to rotate around a common axis YY (e.g., the yaw axis) by providing a rotary pin joint.

[0099] The electrosurgical instrument 10, having two tip portions 16 and 17 that are relatively movable in the opening / closing (OP / CL) direction, may be an active monopolar or bipolar instrument.

[0100] According to one embodiment, at least one distal opening of the protective cap 20 includes a single distal opening 24, and both of the two tip portions 16, 17 of the instrument 10 are located inside the cavity 21 of the cap, i.e., exposed to the outside of the protective cap 20 through the single distal opening 24. In other words, the free ends 18 of each of the two tip portions 16, 17 are located outside the single distal opening 24. In this case, the electrosurgical instrument 10 is preferably monopolar, and the two tip portions 16, 17 can be polarized with the same charge. The two tip portions 16, 17 are movable relative to each other in the opening / closing (OP / CL) direction to perform grasping and / or cutting and / or expanding operations. In addition to the free ends 18, the working distal portions of the tip portions 16, 17, e.g., the grasping and / or cutting and / or expanding surfaces, are also exposed to the outside of the protective cap 20.

[0101] In another embodiment, the articulated end 15 of the electrosurgical instrument 10 comprises two tips 16, 17 made of an electrically conductive material, each having an elongated body that forms a free end 18, the two tips including at least one tip, and the two tips being relatively movable in the opening / closing (OP / CL) direction, and further, the protective device 20 comprises two distal openings 24, 25, each including at least one distal opening, the two distal openings defined by two distal opening edges 26, 27, both of the free ends 18 of the two tips 16, 17 of the articulated cuff 15 are exposed to the outside of the protective device, and the distal opening edges 26, 27 are fitted with mechanical interference to the elongated bodies of the respective tips 26, 27 of the instrument, thereby achieving a sealed state that is individually tightly attached to the elongated bodies of the respective tips 16, 17 of the electrosurgical instrument in any operating configuration of the articulated cuff. The two distal openings 26 and 27 are separated from each other. In this case, the instrument 10 is a bipolar instrument having different polarities between its two tip portions 16 and 17. The tip portions 16 and 17 of the bipolar electrosurgical instrument 10 may have a curved portion 46 to allow the free end 18 to contact each other before their respective proximal portions during the re-closing operation, or they may be formed in various shapes so that contact between the tip portions 16 and 17 occurs only in the vicinity of the free end 18, and contact at the proximal portions of the tip portions near the articular pin 37 is avoided.

[0102] In a preferred embodiment, a protective cap 20 is provided between the two tip portions 16, 17 of the bipolar instrument 10, and the protective cap 20 is provided with a flap 28 made of an insulating, electrically insulating, and fluid-impermeable material, the flap 28 partially defining both of the two distal opening edges 26, 27. The provision of a flap 28 made of insulating material makes it possible to separate and hold the two tip portions 16, 17 of the bipolar active instrument without contact, while avoiding short circuits between the two tip portions 16, 17 which have different polarities. The flap 28 made of insulating material positioned between the tip portions 16, 17 is preferably also thermally insulating.

[0103] The flap 28, made of insulating material, may be formed from the same material as the rest of the protective cap body. Preferably, in this way, the flap 28 extends seamlessly and continuously with the rest of the protective cap body.

[0104] The mechanical properties of the material flap 28 positioned between the two tip portions 16 and 17, as well as the local electrical and / or thermal insulation properties, can be adjusted by acting upon the shape and thickness of the material flap 28.

[0105] The flap 28, made of insulating material and positioned between the two distal openings 26 and 27 of the protective cap 20, may have lower rigidity compared to the rest of the body of the cap 20. The flap 28, made of insulating material and positioned between the two distal openings 26 and 27 of the protective cap 20, may have higher elasticity than the rest of the protective device. The flap 28, made of insulating material and positioned between the two distal openings 26 and 27 of the protective cap 20, may have a smaller thickness than the rest of the protective device. The flap 28, made of insulating material and positioned between the two distal openings 26 and 27 of the protective cap 20, may have a bellows shape including an extendable folding section 31 with multiple material folding sections to accommodate the opening and closing (OP / CL) operation of the tip portions 16 and 17 of the articulated end 15.

[0106] As described above, the joint end 15 is preferably formed from an electrically conductive material, such as a metal, and preferably also thermally conductive. Preferably, the joint end 15 is formed from a support link 35, a proximal link 41, and a plurality of links including at least one end portion 16, 17 made of an electrically conductive material, the plurality of links being mechanically connected to each other (for example by electrically conductive articulated pins) to form an electrically conductive articulated kinetic chain. Each link 41, 35 does not necessarily have to be formed as a single member. At least a portion of the links may have a clevis shape having two projections 36 for assembling articulated pins. As described above, the proximal link 41 may be fixed to the distal end of the positioning shaft and form the distal portion 14 of the positioning shaft 13 itself.

[0107] As described above, the body of the protective cap 20 may include at least one extendable portion to accommodate various operating configurations of the joint end 15 when the rotary joint operates, for example, pitch, yaw, and / or opening and closing.

[0108] The extendable portion includes, or may be formed by, a folding portion 31 that forms a plurality of material folding portions so as to follow the movement of the joint end 15 with minimal mechanical resistance.

[0109] According to a preferred embodiment, the stretchable portion includes an elastically stretchable portion.

[0110] At least one distal opening edge 26, 27 of the protective cap 20 may be formed by an extended collar portion 32. The proximal opening edge 23 of the protective device may also be formed by an extended collar portion 32. Providing an extended collar portion contributes to the formation of a sealed state.

[0111] The body of the protective cap 20 is preferably made of a polymer material such as rubber or plastic, is biocompatible, and is transparent.

[0112] Preferably, the cap is formed from a silicon such as PDMS (polydimethylsiloxane).

[0113] The body of the protective cap 20 preferably has a thickness in the range of 0.1 mm to 0.5 mm, more preferably in the range of 0.2 mm to 0.3 mm, and the thickness does not necessarily have to be constant in each part of the cap 20. For example, the thickness of the protective cap may be smaller in the tapered region that forms the opening. For example, the thickness of the protective cap may be larger at the proximal opening edge and / or distal opening edge.

[0114] For example, according to one embodiment, the protective cap comprises a body having a thickness of 0.3 mm and a proximal opening edge having an extended collar portion with a local thickness of 0.5 mm, the diameter of the proximal through-opening being 3.8 mm and suitable for sealing a positioning shaft with a diameter of 4 mm, and the diameter of the distal through-opening being 0.4 mm. In this example, the opening has an inclination ranging from 20° to 30° with respect to the definable longitudinal direction. Also in this example, the longitudinal length of the protective cap is 12 mm.

[0115] For example, according to another embodiment, the protective cap comprises a body having a thickness of 0.2 mm and a proximal opening edge having an extended collar portion with a local thickness of 0.4 mm, the diameter of the proximal through-opening being 3.8 mm and suitable for sealing a positioning shaft with a diameter of 4 mm, and the diameter of the distal through-opening being 0.4 mm. According to this example, the opening has an inclination in the range of 20° to 30° with respect to the definable longitudinal direction. Also according to this example, the longitudinal extension length of the protective cap is 12 mm.

[0116] According to one embodiment, the material used to manufacture the protective cap is silicon with a hardness in the range of 20A to 40A. According to one embodiment, the thickness of the protective cap body is 0.2 mm, ensuring electrical insulation of approximately 2800 V / mm. The protective cap 20 may be optically transparent and may be formed from optically transparent silicon.

[0117] Preferably, the protective cap 20 is manufactured by molding. For example, micromolding techniques such as injection molding can be used. For example, the protective cap 20 may be manufactured by dip molding.

[0118] For example, as shown in Figures 14A to 14B, the protective cap 20 can be manufactured by dip molding a silicon material, using a support 51 to which a plurality of male elements 52, for example made of metal and having a tapered shape that narrows towards the tip, are assembled. The support 51 to which the male elements 52 are attached is immersed in a tank containing a starting material for the cap, such as silicon. The tank and the male elements 52 may be heatable. After immersion, the support 51 with the male elements 52 coated with polymer material is placed on a structure for drying.

[0119] For example, as shown in Figure 15, the protective cap 20 can be manufactured by injection molding, which includes a mold 60 consisting of two parts 61 and 62, where one part 61 of the two parts of the mold comprises a male element 63 or core 63, and the other part 62 comprises a corresponding female element 64. The mold, or at least the male and female elements, preferably have a cylindrical shape. A mold cavity 65 is formed between the male and female elements, which is filled with a material (e.g., silicone).

[0120] By changing the dimensions of the female element 64 while keeping the male element the same (for example, by forming a wider female mold seat), a thicker mold cavity 65 can be formed, and as a result, the thickness of the resulting protective cap 20 can be adjusted. Similarly, by changing the dimensions of the male element 63 while keeping the female mold seat the same (for example, by forming a thinner core), a thicker mold cavity 65 can also be formed, and as a result, the thickness of the resulting protective cap 20 can be adjusted.

[0121] The body of the protective cap 20 may form visible lines 33 of the material at the points of change in inclination as a result of the molding process.

[0122] In one embodiment, the entire tip links 16, 17, or at least only their distal ends 18, are formed of metal, and an electrical conductor wire is provided directly connected to the tip links 16, 17 or at least their distal ends 18, the electrical conductor wire may be wound around the links of the articular end 15 of the electrosurgical instrument 10 (e.g., support link 35 and proximal link 41). In one embodiment, one or more conductor cables extend along the positioning shaft 13 and supply voltage to the entire metal articular end 15. In one embodiment, such conductor cables extend inside the positioning shaft 13. In one embodiment, such conductor wires extend outside the positioning shaft of the instrument.

[0123] In one embodiment, the positioning shaft is also formed from metal and is used as a conductor to supply voltage to the conductive metal joint end 15, and consequently to its tip portions 16 and 17. The polymer-fabricated tendon 11 can be a low-friction and high-rigidity tendon.

[0124] While the electrocautery function is being used on the biological tissue to be treated, high-temperature steam and smoke are released, which can rapidly damage polymer-fabricated articulate tendons 11 that are not resistant to thermal stress, such as the steel or tungsten operating cables commonly used in known electrosurgical instruments.

[0125] During the use of the electrocautery function, the tissue surrounding the treatment area is heated, but the protective cap 20 prevents overheating of the polymer-fabricated articulate tendon 11, which can occur due to both direct contact with the overheated tissue and direct exposure to the flow of steam or smoke.

[0126] The protective cap 20 preferably comes into close contact with at least one of the tip portions 16, 17 and moves with it. The protective cap 20 also preferably comes into contact with the link 35 of the articulated end 15 and moves with it. According to one embodiment, the protective cap 20 can be bonded to the body of the support link 35.

[0127] The distal openings 26 and 27 elastically extend as the tip portions 16 and 17 open and close, maintaining thermal insulation and a sealed state, thereby preventing steam and / or smoke from entering the cavity 21. If provided, the bellows-shaped foldable extendable portion 31 minimizes the resistance provided by the cap itself during the operation of the joint end 15.

[0128] The two distal openings (i.e., the two separate distal openings 26, 27 of the protective cap 20) allow the tip portions 16, 17 to open and close while maintaining effective insulation. Preferably, the two distal openings 26, 27 of the cap 20 are offset with respect to the opening / closing (OP / CL) direction, that is, in other words, the distal openings 26, 27 are not aligned with the relative approach / separation direction of the tip portions 16, 17, i.e., the opening / closing (OP / CL) direction, as shown, for example, in Figure 13B. According to one embodiment, the two distal openings 26, 27 of the cap 20 have centrosymmetricalness with respect to the axis and / or the definable longitudinal axis of the articular end of the positioning shaft 13 of the electrosurgical instrument 10.

[0129] According to a general embodiment, a remotely operated robotic system 2 for medical or surgical use is provided, the system 2 includes at least one assembly 1 comprising an electrosurgical instrument and protective cap according to one of the embodiments described above.

[0130] The robot system 2 further includes an electric generator 39 for assigning polarity to at least one of the tip sections 16, 17.

[0131] The robot system 2 preferably further comprises a transmission interface 3 that engages with a corresponding proximal transmission interface (backend) 34 of the instrument 10.

[0132] Preferably, the robotic system 2 comprises at least two instruments, one of which is an electrosurgical instrument 10, and the other is a non-active instrument, i.e., an instrument that is not suitable for transmitting electrical / thermal energy to tissue and is disconnected from the electric generator 39.

[0133] The robotic system preferably includes a master console 4 with at least one master control device (not shown) for performing remote control to control the electrosurgical instrument. In particular, the robotic system 2 may include one or more robotic manipulators 5 that can operate under the control of the master console 4. The transmission interface 3 is preferably part of the manipulator 5. A sterile barrier may be interposed between the transmission interface 3 of the manipulator 5 and the proximal transmission interface 34 of the electrosurgical instrument 10.

[0134] In a preferred embodiment, the robotic system 2 further comprises at least one foot switch pedal 30 for controlling the energy supply by an electrosurgical instrument. The foot switch pedal 30 is preferably operatively connected to an electric generator 39.

[0135] The robot system 2 may further include an operating bed or operating table 6 on which the patient 7 lies under operating conditions.

[0136] If the electrosurgical instrument is monopolar, a return electrode 8, which is separated from the articular end 15 of the instrument 10, is preferably provided. On the other hand, if the electrosurgical instrument is bipolar, one of the two tip portions 17 or 16 forms the return electrode, and the other tip portion 16 or 17 forms the active electrode.

[0137] The power generator 39 may be mounted inside the robot manipulator 5, or it may be provided separately and electrically connected to at least one of the end portions 16, 17 of the joint end 15.

[0138] A protective cap 20 for an electrosurgical instrument 10 is provided according to a general embodiment.

[0139] The protective cap 20 may be the protective cap 20 according to any one embodiment described above.

[0140] In particular, according to a preferred embodiment, the protective cap 20 is for an electrosurgical instrument 10 having an articular end 15 with at least one tip 16;17, the protective cap 20 comprises a body made of an electrically insulating material, and includes 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.

[0141] The protective cap preferably has a body that forms a through-sleeve between the proximal opening 22 and the distal openings 24 and 25.

[0142] Preferably, the body of the protective cap 20 is formed from a material that is impermeable to fluids and smoke.

[0143] The body of the protective cap 20 preferably has electrical and thermal insulation properties.

[0144] As a further advantage, at least one distal opening edge 26;27 of the protective cap 20 is fitted with mechanical interference to the elongated body of at least one tip 16;17 of the electrosurgical instrument 10, thereby providing a tightly sealed state to the elongated body of at least one tip 16;17 in any operating configuration of the articular end 15.

[0145] A monopolar electrosurgical instrument 10 is provided according to a general embodiment.

[0146] The monopolar electrosurgical instrument may be an electrosurgical instrument according to any one embodiment of the monopolar electrosurgical instruments described above.

[0147] In particular, according to a preferred embodiment, the monopolar electrosurgical instrument includes a positioning shaft 13 having a distal portion 14, and an articular end 15 having at least one tip portion 16;17 made of an electrically conductive material and connected to the distal portion 14 of the shaft, having an elongated body that forms a free end 18, wherein the at least one tip portion 16;17 of the articular end 15 is movable relative to the positioning shaft 13 and is actuated by at least one actuating tendon 11, the at least one actuating tendon 11 is made of a polymer material.

[0148] Preferably, the positioning shaft 13 and the articulated end 15, which includes at least one tip portion 16, 17, are all formed from an electrically conductive material, thereby creating an electrical continuity from the positioning shaft 13 to the free end 18 of at least one tip portion of the articulated end, and avoiding the need to provide a separate electrical conductor terminated at at least one tip portion. An insulating sheath 47 can be provided to cover the conductive positioning shaft 13.

[0149] In one embodiment, the articulated end 15 includes a support link 35 between the positioning shaft 13 and at least one end portion 16, 17, the support link 35 together with the at least one end portion 16, 17 to form a rotary pin joint including an articulated pin 37 made of an electrically conductive material.

[0150] Preferably, the rotary pin joint is formed by a support link 35, the support link 35 is in close contact with at least one end portion 16, 17 to maximize the contact area.

[0151] In a preferred embodiment, the support link 35 integrally defines two rotary pin joints having mutually orthogonal axes PP and YY, such as the pitch axis PP and the yaw axis YY, as a single member.

[0152] According to one embodiment, the electrosurgical instrument 10 is configured to rotate as a whole around a definable roll rotation axis, which preferably coincides with the longitudinal axis of the positioning shaft 13. Preferably, at least the positioning shaft 13 and the articulated end 15 are integral with respect to roll rotation around the definable roll rotation axis, which preferably coincides with the longitudinal extension axis of the positioning shaft, and is particularly preferable when a rigid and linear positioning shaft is provided.

[0153] By providing the above-mentioned features in combination with each other, or in certain embodiments without combining them, it becomes possible to satisfy the aforementioned requirements, thereby achieving the aforementioned advantages, particularly the following advantages.

[0154] This enables the manufacture of protective caps adapted to protect polymer tendons from excessive heating, wetting, and corrosion caused by smoke and vapors released during electrocautery;

[0155] This prevents the polymer-based articulated tendon from becoming submerged in water, thereby preventing the articulated tendon from being heated by the Joule effect due to electrical conduction;

[0156] At the same time, it makes it possible to eliminate, or at least minimize, the risk of unnecessary contact that may occur between the articular end and the patient's tissue being treated;

[0157] A miniaturized electrical tool is provided, combining high-strength articulated metal parts to withstand the operating force with low-friction, high-rigidity polymer tendons that enable proper sliding and transmission of closing force;

[0158] A miniaturized articulated device is provided, adapted to minimize the number of components to be assembled;

[0159] A miniaturized articulated device is provided that has dimensional tolerances that are difficult to achieve with plastic or other electrically insulating materials;

[0160] A miniaturized articulated device is provided that can be manufactured without using plastic or ceramic parts in the articular end 15, if necessary;

[0161] Links 41, 35, 16, and 17 of the miniaturized electrosurgical instrument are formed from a metallic material and are subjected to voltage.

[0162] It will be fully understood that the combination of features disclosed in the attached claims forms an integral part of this disclosure.

[0163] To address specific situational requirements, those skilled in the art may make various changes and modifications to the embodiments described above, replacing them with other functionally equivalent elements, without departing from the scope of the appended claims. [Explanation of Symbols]

[0164] 1. Assembly, or assembly of electrosurgical instruments and protective caps. 2. Remotely operated robotic systems for medical or surgical use 3. Robot Manipulator Transmission Interface 4 Master Console 5. Robot Manipulator 6. Operating table or operating bed 7 patients 8. Return electrode for active monopolar instruments 10. Electrosurgical instruments, or active surgical instruments, or instruments 11 Polymer fabricated articular tendon for at least one tip 12 Distal terminal portion of the tendon 13 Positioning rod or shaft 14. Distal part of the shaft 15 Articular ends 16. Tip or end link 17. Second tip or end link 18. Free end of the tip 19. Tip operating interface section 20 protective caps 21. Cavity inside the cap 22 Cap proximal opening 23 Proximal opening margin 24 Cap distal opening 25. Second distal opening of the cap 26 Distal opening margin 27. Second distal opening edge of the cap 28. Insulating material flap between the distal openings of the caps. 29. Tapered section of the cap 30 Footswitch pedals 31 Foldable extendable section 32 Extended color section 33 Molding Line 34. Device transmission interface unit, or backend. 35. Articular end support link 36 Protruding part of the support link 37 Joint pins 38. Base of the tip attachment 39 Electric generator 40 Sliding surface for actuation tendon 41. Proximal link of the articular end 42 Opposing surfaces forming a pair of opposing surfaces of the tip link 43 Opposing surfaces forming the other pair of opposing surfaces of the tip link 44 corners 45 Support link acting tendon 46. ​​Curved tip of an active bipolar device 47 Positioning shaft insulating sheath 51 Support 52 Support male element 60 Injection mold 61 Mold parts 62 Other mold parts 63 Male mold element or core of a mold component 64 Female mold element or core seat of the other mold component 65 Mold cavity OP / CL Open / Close PP pitch rotation axis YY Yaw rotation axis RR Roll rotation axis

Claims

1. An electrosurgical instrument (10) having a positioning shaft (13) having a distal portion (14), and an articulated end (15) having an elongated body that forms a free end (18) and includes at least one tip portion (16, 17) made of an electrically conductive material, coupled to the distal portion (14) of the shaft, A protective cap (20) is attached to the joint end (15) of the electrosurgical instrument and has a body made of an electrically insulating material, The proximal opening (22) is defined by the proximal opening edge (23) of the body of the cap, At least one distal opening (24, 25) defined by at least one distal opening edge (26, 27) of the cap, A protective cap (20) having, Equipped with, here, The at least one end portion (16, 17) of the articular end (15) is movable relative to the positioning shaft (13) and is actuated by at least one actuating tendon (11). The articular end (15) has at least one tip portion (16, 17) having an actuation interface portion (19) for receiving actuation force from the at least one actuation tendon (11), The operating interface portion (19) of at least one of the tip portions (16, 17) is located inside the protective cap (20). The aforementioned at least one working tendon (11) is formed at least in part from a polymer material. The body of the protective cap (20) is formed from a thermally insulating material. Furthermore, here, The free end (18) of at least one tip portion (16, 17) of the articulated end (15) is exposed to the outside of the protective cap (20). The body of the protective cap (20) is formed from a material that is impermeable to fluids and smoke. The assembly (1) is fitted by mechanical interference between the at least one distal opening edge (26, 27) of the protective cap (20) and the elongated body of the at least one tip (16, 17) of the electrosurgical instrument (10), thereby providing a tightly sealed state to the elongated body of the at least one tip (16, 17) of the electrosurgical instrument (10) in any operating state of the articular end (15).

2. The articular end (15) has a plurality of polymer-based articular tendons (11) including the at least one articular tendon (11), Each working tendon has its own distal end (12), The assembly according to claim 1, wherein the protective cap (20) covers the entire articular end (15) and all distal ends (12) of the plurality of working tendons.

3. The assembly according to claim 1 or 2, wherein the at least one distal opening edge (26; 27) of the body of the protective cap (20) is elastically stretchable, thereby elastically preloading the elongated body of the at least one tip portion (16; 17) of the electrosurgical instrument, and the mechanical interference and the sealed state are formed by the elastic action.

4. The protective cap (20) is attached to the positioning shaft (13) of the electrosurgical instrument (10), The proximal opening edge (23) of the cap is attached to the positioning shaft (13) in a tightly sealed state. Furthermore, preferably, the assembly according to any one of claims 1 to 3, wherein the proximal opening edge (23) is elastically stretchable so as to be elastically preloaded with respect to the body of the positioning shaft (13) of the electrosurgical instrument (10).

5. The articulated end (15) is formed from an electrically conductive material and has two tip portions (16, 17) each having an elongated body that forms a free end (18). The two tip portions (16, 17) include the at least one tip portion, The two aforementioned tip portions are relatively movable in the opening / closing (OP / CL) direction. Furthermore, here, The at least one distal opening includes a single distal opening (24), Furthermore, here, Both of the two tip portions (16, 17) of the electrosurgical instrument (10) are located inside the protective cap (20). The assembly according to any one of claims 1 to 4, wherein the free end (18) of each tip is exposed to the outside through the single distal opening (27).

6. The articular end (15) of the electrosurgical instrument is formed from an electrically conductive material and has two tip portions (16, 17) each having an elongated body that forms a free end (18). The two tip portions (16, 17) each have at least one tip portion, The two aforementioned tip portions are relatively movable in the opening / closing (OP / CL) direction. Furthermore, here, The protective cap (20) comprises two respective distal openings (24, 25) including the at least one distal opening, and each of the two distal openings is defined by two respective distal opening edges (26, 27) that are separated from each other. Furthermore, here, Both of the free ends (18) of the two tip portions (16, 17) of the joint end (15) are exposed to the outside of the protective cap. The distal opening edges (26, 27) are attached to the elongated bodies of the respective tip portions (16, 17) of the surgical instruments by mechanical interference, thereby achieving a tightly sealed state in which the elongated bodies of the respective tip portions of the electrosurgical instruments (10) are in close contact with each other, regardless of the operating state of the articular end (15). Between the two tip portions (16, 17) of the electrosurgical instrument, the protective cap (20) is provided with a flap (28) made of an insulating material that is electrically and thermally insulating and impermeable to fluids and smoke. The assembly according to any one of claims 1 to 4, wherein the flap (28) partially defines both of the distal opening edges (26, 27).

7. The assembly according to claim 6, wherein the electrosurgical instrument (10) is of the bipolar type, the two tip portions (16, 17) having different electrical polarities.

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

9. The aforementioned joint end (15) is formed of an electrically conductive material such as metal, and preferably also has thermal conductivity. Furthermore, here, Preferably, the articular end (15) is formed from a plurality of links made of an electrically conductive material, each link being mechanically connected to the others to form an electrically conductive articular kinetic chain, according to any one of claims 1 to 8.

10. The assembly according to any one of claims 1 to 9, wherein the protective cap (20) is integrally molded, that is, formed from a single piece of material that is electrically and thermally insulating and impermeable to fluids and smoke.

11. The proximal opening edge (23) of the protective cap (20) defines a larger proximal opening (22) relative to the at least one distal opening (24; 25). Furthermore, here, Preferably, the body of the protective cap (20) has at least one tapered portion (29) that is tapered toward the distal direction, that is, narrows toward the distal direction. Furthermore, here, Preferably, the tapered portion (29) forms the opening of the protective cap (20) in the assembly according to any one of claims 1 to 10.

12. The assembly according to any one of claims 1 to 11, wherein the body of the protective cap (20) comprises at least one extendable portion for accommodating various operating states of the joint end (15).

13. The assembly according to claim 12, wherein the extendable portion includes a foldable portion (31), thereby forming a plurality of foldable portions of the material.

14. The assembly according to claim 12 or 13, wherein the stretchable portion includes an elastically stretchable portion.

15. The assembly according to any one of claims 1 to 14, wherein the at least one distal opening edge (26; 27) of the protective cap is formed from an extended collar portion (32).

16. The body of the protective cap (20) is formed from a biocompatible and preferably transparent polymer material, such as rubber or plastic, such as silicone, i.e., PDMS, and / or The body of the protective cap (20) has a thickness in the range of 0.1 mm to 0.5 mm, preferably in the range of 0.2 mm to 0.3 mm, and / or The assembly according to any one of claims 1 to 15, wherein the body of the protective cap (20) has a Shore hardness in the range of 20A to 40A.

17. A remotely operated robotic system (2) for medical or surgical use, comprising at least one assembly (1) of an electrosurgical instrument and protective cap according to any one of claims 1 to 16.

18. A protective cap (20) for an electrosurgical instrument (10) having an articulated end (15) with at least one tip (16; 17), comprising a body made of an electrically insulating material, The proximal opening (22) defined by the proximal opening edge (23) of the body of the cap, The cap comprises at least one distal opening (24, 25) defined by at least one distal opening edge (26; 27) of the cap, Here, The body of the protective cap (20) is formed from a thermally insulating material. The body of the protective cap (20) is formed from a material that is impermeable to fluids and smoke. The protective cap (20) is fitted with the elongated body of the at least one distal opening edge (26; 27) of the protective cap (20) by mechanical interference, thereby providing a tightly sealed state to the elongated body of the at least one tip (16; 17) of the joint end (15) in any operating state of the joint end (15).

19. A positioning shaft (13) having a distal portion (14), The shaft comprises an articulated end (15) coupled to the distal portion (14) of the shaft, formed from an electrically conductive material, and having an elongated body that forms a free end (18), and including at least one tip portion (16; 17), The at least one end portion (16; 17) of the articular end (15) is movable relative to the positioning shaft (13) and is actuated by at least one actuating tendon (11), The aforementioned at least one working tendon (11) is formed at least in part from a polymer material. Here, Monopolar electrosurgical instrument (10), wherein the positioning shaft (13) and the articular end (15) having at least one tip portion (16; 17) are formed from an electrically conductive material, thereby ensuring electrical continuity from the positioning shaft (13) to the free end (18) of the at least one tip portion (16; 17) of the articular end, and avoiding the need to provide a separate electrical conductor terminated at the at least one tip portion (16; 17).

20. The articulated end (15) has a support link (35) between the positioning shaft and the at least one tip portion. The support link (35), together with the at least one tip, forms a rotary pin joint including an articulated pin (37) made of an electrically conductive material. Furthermore, here, Preferably, the rotary pin joint is formed such that the support link (35) is in close contact with at least one of the tip portions (16; 17), thereby maximizing the contact area between them, and / or The monopolar electrosurgical instrument according to claim 19, wherein the support link (35) integrally defines two rotary pin joints having mutually orthogonal axes.

21. The monopolar electrosurgical instrument according to claim 19 or 20, wherein the positioning shaft (13) is rotatable integrally with the joint end (15) in roll rotation around the roll rotation axis (R-R), and the roll rotation axis (R-R) substantially coincides with the longitudinal extension axis of the positioning shaft.

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