Microsurgical instrument for robotic teleoperation with Anti-electrostatic device

Abstract

Surgical instrument and anti-electrostatic flexible sleeve comprising a surgical instrument for robotic surgery comprising an elongated positioning element and an articulated end at the distal end of the elongated positioning element, wherein the articulated end comprises an operating portion for manipulating a tissue and / or a surgical or microsurgical needle and / or a surgical or microsurgical suture wire and / or an operating micro-instrument; and a flexible sleeve fitted onto the surgical instrument comprising a flexible body made of a dielectric material having an inner surface in contact with the surgical instrument and an outer surface facing away from the inner surface; wherein the flexible sleeve comprises electrically conductive particulate dispersed in the dielectric material of the flexible body thereof, forming one or more electrically conductive paths from the inner surface to the outer surface of the flexible sleeve.

Description

"MICROSU RGICAL INSTRUMENT FOR ROBOTIC TELEOPERATION WITH ANTI-ELECTROSTATIC DEVICE"DESCRIPTION

[0001] . Field of the invention

[0002] . The present invention is generally directed the technical field of robotic systems for surgical and / or microsurgical teleoperation .

[0003] . In particular, the present invention relates to a surgical instrument and flexible sleeve assembly.

[0004] . Furthermore, the present invention relates to a method for manufacturing the flexible sleeve.

[0005] . Prior art

[0006] . Robotic surgery apparatuses are generally known in the art and typically comprise a central robotic tower (or cart) 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.

[0007] . Generally, known surgical instruments for teleoperated robotic surgery comprise a proximal interface portion (or backend portion , according to a terminology commonly adopted in the field) having an interface intended to be operated by a robotic manipulator, an elongated element such as a rod or a shaft, an articulated device (e.g . , a robotic wrist), and an operating terminal end (e.g . , needle-driver, scissors).

[0008] . In the known surgical instruments having an articulated wrist, it consists of a plurality of links moved by a plurality of tendons (or actuating cables) . One or more end links can have a free end forming the aforementioned operating end, and are for exampl e adapted to operate directly on a patient’s anatomy and / to handle a needle as well as a suture wire for performing anastomoses or other surgical therapies.

[0009] . Unlike the known surgical instruments comprising an articulated wrist, surgical instruments having an articulated device of the "snake" type are also known , i.e. , comprising a plurality of stacked vertebrae which aremovable with respect to each other by means of a plurality of actuating cables or tendons.

[0010] . In fact, in the field of robotic surgery, the s urgical 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.

[0011] . For example, the prior art document US-2015-0223897 shows a sterile drape solution covering a robotic arm , in which the sterile drape itself has an electrical connector embedded in the flexible body thereof to make an electrical connection .

[0012] . For example, documents 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 wrist and therefore of the operating end or end-effector. As the size of the articulated wrist actuated by means of tendons decreases, clearly, each longitudinal shortening or lengthening of the length of a tendon activates a corresponding angular movement of the wrist which gradually increases in magnitude. As shown , for example, in the prior art document US-2021 -106393 to the same Applicant, the tendons themselves can be made of a polymer material to further reduce the dimensions of the articulated wrist as well as the tendon -articulated wrist sliding friction coefficient.

[0013] . Typically, in robotic microsurgery, the articulated end of the surgical instrument comprises two links or tips or jaws configured to grasp miniaturized surgical needles and make sutures, such as small -gauge blood vessel anastomoses.

[0014] . For example, WO-2023-062553 to the same Applicant shows a solution of miniaturized gripping surfaces of an articulated end adapted to be firmly grasp very small gauge needles, i.e. , less than or equal to 8 / 0 in size (about 150 pm) as well as less than or equal to 1 2 / 0 (about 50pm), as well as miniaturized suture wires having a diameter less than 50pm (for example less than or equal to 30 pm) .

[0015] . For example, the prior art document US-2023-0000542 shows an articulated end of an electro-surgical instrument i.e. , electro-cautery on which a multi-layer insulating sleeve is fitted. Such a multi-layer insulating sleeve comprises an electrically conductive inner layer for making a conductive path back to the electrosurgical energy generator.

[0016] . Therefore, the need is felt to provide an improved surgical instrument solution for microsurgical applications which is suitable for an extreme miniaturization of the operating ends thereof, as well as of the needles and suture wires or other components used in the microsurgical operating field.

[0017] . Solution

[0018] . It is an object of the present invention to devise a solution capable of obviating the drawbacks complained of with reference to the prior art.

[0019] . This and other objects are achieved with an assembly according to claim 1 , as well as with a system according to claim 10, as well as with a method according to claim 11 .

[0020] . Some advantageous embodiments are the subject of the dependent claims.

[0021] . According to an aspect of the invention, an assembly comprises a surgical instrument and an anti-electrostatic flexible sleeve.

[0022] . The surgical instrument comprises an elongated positioning element and an articulated end at the distal end of the elongated positioning element, in which the articulated end comprises an operating portion for manipulating a tissue and / or a surgical or microsurgical needle and / or a surgical or microsurgical suture wire and / or an operating micro -instrument.

[0023] . The flexible sleeve is fitted onto the surgical instrument an d comprises a flexible body made of a dielectric material having an inner surface in contact with the surgical instrument and an outer surface facing away from the inner surface.

[0024] . The flexible sleeve comprises electrically conductive particulate dispersed in the dielectric material of the flexible body thereof, forming one or more electrically conductive paths from the inner surface to the outer surface of the flexible sleeve.

[0025] . In accordance with an embodiment, the elongated positioningelement of the surgical instrument comprises electrically conductive material in electrical conduction communication with the flexible sleeve.

[0026] . In accordance with an embodiment, the inner surface of the flexible sleeve is in contact with the distal end of the elongated positioni ng element of the surgical instrument.

[0027] . In accordance with an embodiment, the operating portion of the articulated end of the surgical instrument is exposed outside the flexible sleeve. Preferably, the operating portion comprises two tips or jaws, each tip of said two tips comprising a gripping surface thereof , the gripping surfaces being mutually movable relatively towards and away from each other; and in which at least the gripping surfaces of the tips of the articulated end are exposed outside the flexibl e sleeve.

[0028] . In accordance with an embodiment, the conductive particulate is dispersed in a polymer matrix, said polymer matrix acting as a flexible dielectric material.

[0029] . The polymer matrix in which the conductive particulate is dispersed can be made of silicone rubber.

[0030] . The conductive particulate of the flexible sleeve can comprise carbonaceous nano- and / or microstructures, such as carbon nanotubes.

[0031] . According to an embodiment, the flexible sleeve comprises one or more additives for reducing the surface tension of the outer surface of the flexible sleeve.

[0032] . According to an aspect of the invention, an assembly comprises a surgical instrument and a flexible sleeve, the surgical instrument comprising an elongated positioning element and an articulated end at the distal end of the elongated positioning element, in which the articulated end comprises an operating portion for manipulating tissue and / or a surgical or microsurgical needle and / or a surgical or microsurgical suture wire and / or an operating micro-instrument. The flexible sleeve is fitted onto the surgical instrument and comprises a flexible body made of a dielectric material having an inner surface in contact with the surgical instrument and an outer surface facing away from the inner surface. The flexible sleeve comprises means for reducing the adhesiveness on the outer surface thereof.

[0033] . The means for reducing the adhesiveness of the outer surface of the flexible sleeve can comprise one or more additives for reducing thesurface tension of the flexible sleeve body. For example, the dielectric material of the flexible sleeve body comprises silicone rubber, and preferably platinum silicone rubber, made as a polyaddition of two components, in which one of the two components comprises said one or more additives for reducing surface tension .

[0034] . The means for reducing the adhesiveness of the outer surface of the flexible sleeve can comprise electrically conductive particulate dispersed in the dielectric material of the flexible body thereof, forming one or more electrically conductive paths from the inner surface to the outer surface of the flexible sleeve.

[0035] . Brief description of the figures

[0036] . Further features and advantages of the invention will become apparent from the following description of preferred embodiments , given by way of non-limiting indication, with reference to the accompanying drawings which are briefly described below. Note that references to “an” embodiment in this disclosure do not necessarily refer to the same embodiment and are to be understood as at least one. Moreover, for reasons of conciseness and reduction of the total number of figures, a certain figure can be used to illustrate the features of more than one embodiment, and not all the elements of the figure can be necessary for a certain embodiment.

[0037] . Figure 1 A is an axonometric view of a robotic system for medical and / or surgical teleoperation , according to an embodiment.

[0038] . Figure 2 is an axonometric view of a surgical instrument, according to an embodiment.

[0039] . Figure 3 is an axonometric view of an articulated end of a surgical instrument comprising a flexible sleeve acting as an antistatic device, according to an embodiment.

[0040] . Figure 4 is an axonometric view of an articulated end of a surgical instrument comprising a flexible sleeve acting as an ant istatic device, according to an embodiment.

[0041] . Figure 5 is a section view of a portion of a flexible sleeve, according to an embodiment.

[0042] . Figures 6 and 7 are diagrammatic vertical elevation views of a surgical instrument, according to some embodiments.

[0043] . Figures 8, 9, and 1 0 are partial section views of a flexiblesleeve, according to some embodiments.Figures 1 1 and 1 2 are section views of an injection molding mold, according to an embodiment.

[0044] . Figure 13-A is an axonometric view of a plurality of tubular cores for dip molding , according to an embodiment.

[0045] . Figure 13-B is a vertical elevation view of a tubular core for dip molding , according to an embodiment.

[0046] . Figures 14-A, 14-B and 14-C are diagrammatic views pictorially showing a possible electrostatic polarization charge distribution sequence, according to an embodiment.

[0047] . Detailed description of some embodiments

[0048] . Reference 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 functio ns such as those shown in different drawings can be combined in any suitable manner in one or more embodiments.

[0049] . In accordance with a general embodiment, there is provided an assembly 10 comprising a surgical instrument 1 and a flexible sleeve 5.

[0050] . The surgical instrument 1 is preferably for robotic microsurgery.

[0051] . In particular, the surgical instrument 1 comprises an elongated positioning element 2 and an articulated end 3 at the distal end 4 of the elongated positioning element 2. The articulated end 2 can be an articulated wrist comprising rotational joints with axes orthogonal to each other.

[0052] . The articulated end 3 comprises an operating portion 13 for manipulating a surgical or microsurgical tissue and / or needle NE and / or a surgical or microsurgical suture wire SU and / or an operating microinstrument.

[0053] . The flexible sleeve 5 is fitted onto the surgical instrument 1 and comprises a flexible body made of a dielectric material having an inner surface 6 in contact with the surgical instrument and an outer s urface 7 facing away from the inner surface 6. In accordance with a preferred embodiment, the flexible sleeve is made of silicone rubber.

[0054] . The flexible sleeve 5 preferably comprises a proximal opening 16 into which the surgical instrument 1 is inserted and at least one opposite distal opening 1 5 for exposing a portion of the surgical instrument, for example the operating portion 13.

[0055] . Advantageously, the flexible sleeve 5 comprises electrically conductive particulate dispersed in the dielectric material of the flexible body thereof, forming one or more electrically conductive paths from the inner surface 6 to the outer surface 7 of the flexible sleeve.

[0056] . By virtue of the provision of said electrically conductive particulate dispersed in the sleeve flexible body, it is possible to make one or more conductive paths for dispersing the electrostatic charge which could undesirably accumulate on the outer surface 7 of the sleeve itself and which could cause undesirable electrostatic attraction phenomena on the suture wire SU as well as on the needle N E. In particular, in the field of robotic microsurgery, the provision of surface electrostatic charges is highly undesirable due to the minimal masses and weights involved and the miniaturization of components, such as miniaturized needles and suture wires.

[0057] . By virtue of the dispersion of the electrically conductive particulate in the thickness TH of the flexible sleeve 5, i.e. , from the inner surface 6 thereof in contact with the surgical instrument, to the outer surface 7 thereof which can come into contact when in operating conditions with patient tissues as well as with miniaturized needles and sutures, electrostatic attraction phenomena are avoided.

[0058] . Of course, not necessarily the one or more electrically conductive paths through the thickness of the flexible sleeve 5 are discharged to the ground, and could be discharged with a discharge surface of the surgical instrument itself, for example a metal surface of the elongated positioning element which is located outside the patient's body when in operating conditions.

[0059] . In accordance with a preferred embodiment, the elongated positioning element 2 of the surgical instrument 1 comprises electrically conductive material in electrical conduction communication with the flexible sleeve 5. Preferably, the elongated positioning element 2 comprises an outer surface 1 7 made of metal, for example surgical steel, which at thedistal end thereof is in contact with the conductive particulate of the inner surface 6 of the flexible sleeve 5, so as to distribute the electrostatic polarization on the outer surface 17 of the elongated positioning element 2.

[0060] . In accordance with a preferred embodiment, the inner surface 6 of the flexible sleeve 5 with the conductive particulate thereof is in contact with the articulated end 3 of the surgical instrument. The articulated end 3 is preferably made of metal, for example surgical steel. Thereby, the electrostatic charge is distributed through the metal body of the articulated end. Preferably, the articulated end 3 is in turn in electrical conduction communication with the elongated positioning element 2. Therefore, in accordance with a preferred embodiment, the flexible sleeve 5 is fitted with contact on both the distal end 4 of the elongated positioning eleme nt 2 and on the articulated end 3 of the surgical instrument.

[0061] . The operating portion 13 of the articulated end 3 of the surgical instrument 1 is instead preferably exposed outside the flexible sleeve 5 to be able to manipulate the tissues and / or needles and / or sutures.

[0062] . In accordance with a preferred embodiment, the operating portion 13 of the articulated end 3 comprises two tips 8, 9 or jaws 8, 9, each tip of said two tips comprising a gripping surface 1 1 , 1 2 thereof. The gripping surfaces 1 1 , 12 are preferably facing each other. The gripping surfaces 1 1 , 12 can comprise a surface machining , such as micro-texturing , to improve grip when in use conditions. Preferably, therefore, the gripping surfaces 1 1 , 12 are movable relatively towards and away from each oth er OP / CL, for example in opening / closing as, for example, the two tips or jaws 8, 9 can be articulated in a rotational joint and movable in opening / closing . Alternatively or in addition, the gripping surfaces can belong to tips or jaws which are guided to move relatively along a trajectory that can be substantially straight in relative approach / separation, and for example movement guides such as oval slots and / or tracks can be provided.

[0063] . Preferably, therefore, at least the gripping surfaces 1 1 , 12 of the tips 8, 9 of the articulated end 3 are exposed outside the flexible sleeve 5, i.e. , they are exposed outside the at least one distal opening 15 of the flexible sleeve 5.

[0064] . The flexible sleeve 5 can for example comprise two distal openings 15 for individually exposing the two tips or jaws 8, 9, respectively.For this purpose, the flexible sleeve 5 can comprise a bifurcation 1 8. According to another embodiment, the flexible sleeve 5 comprises a single distal opening 15 from which both tips or jaws 8, 9 are exposed .

[0065] . Preferably, the tips or jaws 8, 9 are moved by actuation tendons 19 which can be made of a polymer material, for example braided polymer fibers of high molecular weight polyethylene (U HMWPE) , and in such a case the flexible sleeve 5 is preferably fitted onto the articulated end to cover the actuation tendons 1 9 to protect them from the operating environment when in operating conditions which can be corrosive to the tendons. In this case, therefore, the actuation tendons 19 are inside the longitudinal cavi ty of the flexible sleeve 5, which therefore acts as a tendon protection device. For this purpose, the edge of the at least one distal opening 15 of the flexible sleeve 5 can be fluid-tightly adhered against the body of the at least one tip 8, 9.

[0066] . The flexible body of the sleeve 5 can be elastically stretchable to accommodate the operating movements of the articulated end onto which it is fitted (for example pitch and / or yaw and / or opening / closing or grip movements and / or others). In accordance with an embod iment, the body of the flexible sleeve is made narrower than the size of the articulated end to impose an elastic deformation during assembly so as to be close-fitting on the body of the articulated end when fitted thereon .

[0067] . In accordance with an embodiment, the conductive particulate is dispersed in a polymer matrix, and it is the polymer matrix which acts as a flexible dielectric material. The polymer matrix can be polyurethane. In accordance with a preferred embodiment, and the polymer matrix in which the conductive particulate is dispersed is made of silicone rubber, for example polydimethylsiloxane or PDMS. For example, the silicone rubber is a platinum silicone rubber.

[0068] . The conductive particulate of the flexible sleeve 5 preferably comprises carbon and / or graphene nanotubes. In accordance with an embodiment, the conductive particulate is made exclusively of carbon nanotubes dispersed in a polymer matrix which is silicone rubber. The conductive particulate can comprise fullerenes or other carbonaceous micro- and / or nano-structures. The concentration of the carbonaceous structures of the conductive particulate with respect to the polymer matrix(silicone rubber) is preferably less than 10% by weight and according to a preferred embodiment is less than 5% by weight, and even more preferably belongs to the range 1 %-3% by weight with respect to the weight of the PDMS silicone. In essence, according to a preferred embodiment the platinum silicone is doped with the conductive particulate in the form of carbonaceous nano- or microstructures.

[0069] . In accordance with another embodiment, the conductive particulate comprises metal particles having nanometer and / or micrometer size. For example, the conductive particulate comprises copper and / or silver particles. Other metals can be employed, such as gold and / or platinum .

[0070] . In addition to the conductive particulate, at least one flexible electrical conductor 14 made of metal, such as a metal wire and / or a metal mesh, can be inserted into the flexible sleeve 5, for example as a vascular stent. Thereby, the electrical conductivity of the flexible sleeve can be improved for anti-electrostatic purposes. In accordance with an embodiment, the flexible electrical conductor 14 is exposed with a proximal contact 19 thereof outside the inner surface 6 of the flexible sleeve, and for example, is in contact with the distal portion 4 of the elongated positioning element 2. and / or with the articulated end 3. To expose the flexible electrical conductor from the inner surface 6 of the flexible sleeve 5 it is possible, for example, to abrade the polymer material of the flexible sleeve at the proximal contact 19, thereby exposing a surface, e.g . , a plate surface, of the flexible electrical conductor. The flexible electrical conductor 14 can be exposed outside the outer surface of the flexible sleeve, for anti electrostatic purposes.

[0071] . As mentioned above, the operating portion 13 of the articulated end is made of an electrically conductive material, for example surgical steel. The gripping surfaces can be coated with ceramic material and / or can be surface treated to reduce local electrical conductivity (e.g . , by localizing a phase to surface transformation).

[0072] . The articulated end 3 can be wholly made of an electrically conductive material, and for example comprises a plurality of links including , in addition to the two tips 8, 9 or jaws, also a support link such as a link to the clevis rotatably supporting the two tips 8, 9. The tips or jaws can be constrained to the support link by providing a pin which can also be madeof surgical steel. Proximally to the support link, a further proximal link can be included to create an articulated link between the support link and the distal portion of the elongated positioning element 2.

[0073] . The elongated positioning element 2 is preferably an internally hollow pole or rod or rigid shaft made of a metal material, and can be coated at least in part with a dielectric layer (electrically insulating). In accordance with an embodiment, it is possible to include an electrical conductor which extends inside the cavity of the positioning rod or shaft or pole to distribute the electrostatic charge from the flexible sleeve and thereby result in electrical conduction communication therewith.

[0074] . In accordance with an embodiment, the elongated positioning element 2 comprises one or more joints and can for example comprise a plurality of stacked vertebrae.

[0075] . The flexible sleeve 5 can comprise in the polymer matrix thereof one or more additives for reducing the surface tension of the outer surface 7 of the flexible sleeve. The adhesive capacity of the flexible sleeve 5 is thereby further reduced. In other words, the risk of tissues, needles and suture wires sticking to the flexible sleeve is thereby minimized, becau se in addition to the anti-electrostatic function, the flexible sleeve is externally non-sticky, i.e. , non-tacky. For this purpose, the flexible sleeve 5 can be made of platinum silicone rubber by means of polyaddition of two components (bi-component), in which one of the two components (or both) comprises said one or more additives for reducing the surface tension of the silicone rubber. The concentration of said two or more additives in the precursor component is preferably less than 1 0% by weight and preferably in the range from 0.5% by weight to 5% by weight, and even more preferably in the range from 1 % by weight to 3% by weight.

[0076] . As mentioned above, preferably, the conductive particulate is dispersed so as to make an electrically conductive path through the entire thickness TH of the flexible sleeve 5, i.e. , from the outer surface 7 to the inner surface 6.

[0077] . In accordance with a general embodiment, there is provided a robotic system 20 for surgical or microsurgical teleoperation comprising at least one assembly 1 0 of surgical instrument 1 and anti -electrostatic flexible sleeve 5 according to any of the previously described embodiments.

[0078] . Preferably, the surgical instrument is an instrument unsuitable for delivering radiofrequency energy, i .e. , it is not an el ectrosurgical instrument, i.e. , it is a non-active instrument such as a gripper, a needle- driver / sutures cutter, surgical scissors or a dilator. In the case of a dilator, the operating portion 13 does not comprise gripping surfaces but opposite facing dilation surfaces.

[0079] . In accordance with a preferred embodiment, the surgical instrument 1 is releasably mounted on a motorized robotic manipulator 21 of the robotic system 20 through a sterile barrier 22, i.e. , downstream of a bacterial separation barrier which can comprise one or more sterile drapes made of sheets of non-conductive (dielectric) polymer material. Therefore, the robotic system 20 can be unsuitable for making a grounding connection of the assembly of surgical instrument 1 and anti -electrostatic flexible sleeve 5, and thus the electrostatic charge can be distributed on the outer surface of the elongated positioning element 2.

[0080] . In accordance with a preferred embodiment, two assemblies 1 0 of surgical instrument 1 and flexible sleeve 5 are provided on th e same robotic system 20. Therefore, it is possible to provide two respective motorized robotic manipulators 21 . The two motorized robotic manipulators 21 are preferably commanded under the control of two respective master control devices (not shown).

[0081] . The surgical instrument 1 preferably comprises a proximal transmission interface portion 23 thereof which interfaces with the respective motorized robotic manipulator 21 through the sterile barrier 22, so that the actuation tendons 1 9 of the surgical instrumen t are moved through the sterile barrier, avoiding providing motors in the surgical instrument itself which is therefore suitable for the sterile operating environment and which can be made as a disposable device.

[0082] . Figures 14-A, 14-B and 14-C diagrammatically show a possible distribution sequence of the electrostatic charge migrating from the outer surface 7 of the flexible silicone rubber sleeve to the outer metal surface 1 7 of the elongated positioning element 2 by means of the contact between the inner surface 6 of the flexible sleeve and the distal portion 4 of the elongated positioning element (the articulated end is not shown) . In particular, the electrostatic polarization charges are indicated herein with the signs + and- and the arrows indicate the migration direction of the electrostatic polarization charges.

[0083] . A method for manufacturing an anti-electrostatic flexible sleeve 5 will be described below.

[0084] . In accordance with a general embodiment, a method for manufacturing a flexible sleeve 5 comprising a fl exible body made of a dielectric material and electrically conductive particulate comprises the step of dispersing the conductive particulate in a polymer matrix, e.g . , silicone rubber.

[0085] . The method then comprises the step of arranging the polymer matrix with dispersed conductive particulate around a tubular core 25. The tubular core 25 can be a male element of a mold 24 for injection molding , as shown for example in Figure 11 . The tubular core 25 can be a dip molding core, as shown for example in Figure 13-B.

[0086] . The method further comprises the steps of solidifying the dispersed conductive particulate polymer matrix and separating the tubular core 25 from the solidified conductive particulate polymer matrix.

[0087] . Where the tubular core 25 is a male element of an injection molding mold, the method can comprise mounting a female element 26 to the male element of the injection molding mold, making a mold cavity 27 between the male element (the tubular core 25) and the female element 26 of the injection molding mold 24 and casting the polymer matrix with conductive particulate dispersed in the mold cavity 27.

[0088] . In accordance with an embodiment, the method comprises the further step of arranging a flexible metal conductor 14, for example a metal wire and / or a metal mesh , in the mold cavity 27 as shown, for example, in Figure 12.

[0089] . Where the tubular core 25 is a dipping core, the method can comprise at least one of the following further steps of heating the tubular core 25, and / or dipping the tubular core 25 into the polymer matrix with dispersed conductive particulate, and / or cutting the distal end of the solidified polymer matrix once separated from the tubular core, so as to make a distal opening 15. The polymer matrix with conductive particulate can be contained in a tank (not shown) , in which the tank lid 28 can comprise a plurality of tubular cores 25 extending cantilevered therefrom to immersein the tank so as to make a plurality of flexible sleeves at a time, favoring the mass production of the flexible sleeve.

[0090] . In accordance with a general embodiment, a method for manufacturing an anti-electrostatic flexible sleeve 5 having electrically conductive particulate dispersed in a silicone rubber matrix comprises the steps of : (i) providing two precursor components for platinum bicomponent silicone rubber; and (ii) adding , to one of the two precursor components, one or more additives to reduce the surface tension, in which the concentration of said one or more additives belonging to the range from 0.5% by weight to 5% by weight; and (iii) joining the two precursor components.

[0091] . At this point, in accordance with an embodiment, the flexible sleeve is allowed to rest for one or two days so that the contact with air favors the reduction of the surface tension of the outer surface 7 of the flexible sleeve 5, i.e. , allows the one or more additives to act. An example of such an additive is known under the trade name "Slide Std” from Smooth On.

[0092] . As mentioned above, the concentration of said one or more additives is preferably in the ran ge from 1 % by weight to 3% by weight.

[0093] . By virtue of the features described above, provided jointly or separately in particular embodiments, it is possible to meet the aforementioned needs, obtaining the aforementioned advantages, and in particular:

[0094] . - one or more electrically conductive paths are made from the outer surface to the inner surface of the flexible sleeve by means of dispersion of conductive particulate in the flexible and electrically insulating body of the sleeve itself , so as to minimize the ri sk of accumulation of electrostatic charges on the outer surface of the flexible sleeve itself, which therefore acts as an antistatic device;

[0095] . - the conductive particulate can substantially be a powder or dust of micrometric and / or nanometric conductive particles which are incorporated by dispersion inside the dielectric polymer material of the insulating sleeve body;

[0096] . - therefore, the one or more electrically conductive paths extending from the inner surface of the sleeve in contact with the surgicalinstrument to the outer surface of the sleeve itself are formed by the union of a multiplicity of conductive particles which are in direct contact with each other, forming electrical conduction paths, and which are incorporated inside the polymer body of the sleeve itself ;

[0097] . - in particular, the sleeve can be made in silicone rubber, which is a material tending to become electrostatically charged over time, i.e. , during use;

[0098] . - unwanted electrostatic charges are avoided on the flexible sleeve body fitted on the articulated end of the surgical instrument which could cause electrostatic attraction of metal components and not of the operating field during a microsurgical operation ;

[0099] . - a non-sticky flexible sleeve is made which therefore minimizes the risk of adhesion with metal components and not of the operating field during a microsurgical operation ;

[0100] . - the actuation tendons 1 9 can be protected from corrosion ;

[0101] . - in fact, the articulated parts and more often the articulated ends can be protected by more or less elastic cuffs / or sleeves which in some cases electrically insulate the covered articulated part or in others protect such a part from the ingress of body fluids or other elements and such cuffs can be applied to articulated instruments with different clinical fu nctions, for example cold dissection (scissors), heated dissection (monopolar or bipolar), but also the manipulation of tissues or sutures (needle driver or dilators) ; in the case in particular of forceps with the manipulation function, any adhesiveness of the cuff towards tissues or sutures generated by the material itself or by residual electrostaticity represent a significant limitation in the possibility of use in microsurgery.

[0102] . It is well understood that the combinations of features disclosed in the appended claims form an integral part of the present disclosure.

[0103] . In order to meet specific, contingent needs, those skilled in the art may make several changes and adaptations to the above-described embodiments and can replace elements with others which are f unctionally equivalent, without departing from the scope of the appended claims.LIST OF REFERENCE SIGNS1 Surgical instrument2 Elongated positioning element3 Articulated end4 Distal end of the elongated positioning element5 Flexible sleeve6 Inner surface of the sleeve7 Outer surface of the sleeve8 First tip or jaw9 Second tip or jaw10 Surgical instrument and anti-electrostatic flexible sleeve assembly11 Gripping surface of the first tip or jaw12 Gripping surface of the second tip or jaw13 Operating portion of the articulated end14 Flexible electrical conductor15 Distal opening of the sleeve16 Proximal opening of the sleeve17 Outer surface of the elongated positioning element18 Bifurcation19 Exposed surface20 Robotic system for surgical or microsurgical teleoperation21 Motorized robotic manipulator22 Sterile barrier23 Proximal interface portion of the instrument24 Mold25 T ubular core26 Female element of the mold27 Mold cavity28 LidDISTAL Distal direction OP / CL Relative degree of freedom of approach / separation TH Sleeve wall thickness NE Surgical or microsurgical needle SU Surgical or microsurgical suture wire

Claims

CLAIMS1. A surgical instrument and anti-electrostatic flexible sleeve assembly comprising-a surgical instrument (1 ) for robotic surgery comprising an elongated positioning element (2) and an articulated end (3) at the distal end (4) of the elongated positioning element (2), wherein the articulated end (3) comprises an operating portion for manipulating a tissue and / or a surgical or microsurgical needle (NE) and / or a surgical or microsurgical suture wire (SU) and / or an operating micro-instrument; and- a flexible sleeve (5) fitted onto the surgical instrument (1 ) comprising a flexible body made of a dielectric material having an inner surface (6) in contact with the surgical instrument and an outer surface (7) facing away from the inner surface (6) ; wherein the flexible sleeve (5) comprises electrically conductive particulate dispersed in the dielectric material of the flexible body thereof, forming one or more electrically conductive paths from the inner surface (6) to the outer surface (7) of the flexible sleeve (5) .

2. Assembly according to claim 1 , wherein the elongated positioning element(2) of the surgical instrument (1 ) comprises electrically conductive material in electrical conduction communication with the flexible sleeve (5).

3. Assembly according to claim 1 or 2, wherein the inner surface (6) of the flexible sleeve (5) is in contact with the distal end (4) of the elongated positioning element (2) of the surgical instrument (1 ).

4. Assembly according to any one of the preceding claims, wherein the inner surface (6) of the flexible sleeve (5) is in contact with the articulated end(3) of the surgical instrument ( 1 ) .

5. Assembly according to any one of the preceding claims, wherein the operating portion of the articulated end (3) of the surgical instrument ( 1 ) is exposed outside the flexible sleeve; and wherein, preferably, the operating portion comprises two tips or jaws (8, 9), each tip of said two tips comprising a gripping surface (1 1 , 1 2) thereof , the gripping surfaces being mutually movable relatively towards and away from each other (OP / CL) ; and wherein at least the gripping surfaces of the tips of the articulated end are exposed outside the flexible sleeve (5).

6. Assembly according to any one of the preceding claims, wherein the conductive particulate is dispersed in a polymer matrix, said polymer matrix acting as a flexible dielectric material ; and wherein , preferably, the polymer matrix in which the conductive particulate is dispersed is made of silicone rubber, such as platinum silicone rubber.

7. Assembly according to any one of the preceding claims, wherein the conductive particulate of the flexible sleeve (5) comprises carbonaceous nano- and / or microstructures, such as carbon nanotubes.

8. Assembly according to any one of the preceding claims, wh erein the flexible sleeve (5) further comprises a flexible electrical conductor ( 14), such as a metal wire and / or a metal mesh ; and wherein , preferably, the flexible electrical conductor is exposed from the inner surface (6) of the flexible sleeve, and for example is in contact with the distal portion (4) of the elongated positioning element (2) and / or with the articulated end (3) .

9. Assembly according to any one of the preceding claims, wherein the flexible sleeve (5) comprises one or more additives for reducing the surface tension of the outer surface (7) of the flexible sleeve.

10. A robotic system (1 0) for surgical or microsurgical teleoperation comprising at least one surgical instrument ( 1 ) according to any one of the preceding claims.11 . A method for manufacturing a flexible sleeve (5) comprising a flexible body made of a dielectric material and electrically conductive particulate comprising the following steps of :- dispersing the conductive particulate in a polymer matrix;- arranging the polymer matrix with dispersed conductive particulate around a tubular core (25) ;- solidifying the polymer matrix with dispersed conductive particulate;- separating the tubular core from the solidified polymer matrix with conductive particulate.

12. Method according to claim 11 , wherein the tubular core (25) is a male element of an injection molding mold (24) ; and wherein, preferably, the method comprises the following further steps of :-mounting a female element to the male element of the injection molding mold, thus obtaining a mold cavity between the male element and the female element of the injection molding mold;- casting the polymer matrix with dispersed conductive particulate into the mold cavity; and / or- arranging a flexible metal conductor, such as a metal mesh , in the mold cavity.

13. Method according to claim 1 1 , wherein the tubular core (25) is a dip molding core; and wherein , preferably, the method comprises the following further steps of :- heating the tubular core;- dipping the tubular core in the polymer matrix with dispersed conductive particulate.

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