Surgical or microsurgical instrument for robotic teleoperation comprising a flexible sleeve provided with at least one electrically conductive path

Abstract

Surgical instrument for robotic microsurgery comprising at least one joint of motion between the proximal portion and the distal portion; a flexible sleeve fitted onto the at least one joint of motion said sleeve comprising flexible body, adapted to deform to conform to various operating configurations of the at least one joint of motion; wherein said flexible sleeve comprises at least one electrically insulating portion and at least one electrically conductive path and wherein said at least one electrically conductive path comprises a proximal contact and a distal contact, located proximal and distal to said joint of motion of the surgical instrument; a flexible electric conductor extended from the proximal contact to the distal contact; and wherein the flexible electric conductor is between the electrically insulating portion of the flexible sleeve and the at least one joint of motion of the surgical instrument.

Description

Surgical or microsurgical instrument for robotic teleoperation comprising a flexi ble sleeve provided with at least one electrically conductive pathDESCRIPTION

[0001] . Field of the invention

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

[0003] . In particular, the present invention relates to a surgical instrument comprising a flexible sleeve provided with at least one electrically conductive path.

[0004] . Furthermore, the present invention relates to the aforesaid flexible sleeve provided with at least one electrically conductive path .

[0005] . In addition, the present invention relates to a method for manufacturing said flexible sleeve.

[0006] . Prior art

[0007] . 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.

[0008] . 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).

[0009] . In the known surgical instruments having an articulated wrist, it is made of a plurality of links moved by a plurality of tendons (or actuating cables) . One or more terminal links can have a free end forming the aforementioned operating end, and are for example adapted to operate directly on a patient’s anatomy and / to handle a needle as well as a suture thread for performing anastomoses or other surgical therapies.

[0010] . 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 are movable with respect to each other by means of a plurality of actuating cables or tendons.

[0011] . In fact, in the field of robotic surgery, the surgical instrument is a component intended to operate in a sterile environment and typically a sterile barrier is interposed between the backend portion of the instrument and the counter-portion of the actuation interface, so that the robotic manipulator is in the non-sterile region of the operating set-up. Therefore, the motors are normally placed in the manipulator, i.e. , on the non -sterile side, and the surgical instrument lacks motors.

[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 polymer material to further reduce the dimensions of the articulated wrist as well as the tendon -articulated wrist sliding friction coefficient.

[0013] . The provision of such polymer tendons can impose ded icated control algorithms, as shown , for example, in WO-2022-264078, WO-2022- 264075, WO-2022-264080 and WO-2023-047300 to the same Applicant.

[0014] . Surgical instruments of the type adapted to transmit electrical energy to tissues, such as electro-cauterizing surgical instruments for robotic surgery, are also known. Some known examples of such instruments are shown in prior art documents US-6840938, US-7824401 , US-10376331 , US-8398634, US-10716617, and US-2022-133388.

[0015] . The known electrosurgical instruments typically comprise one or more conductors for transmitting electrical energy from the robotic manipulator, by means of the transmission interface portion of the surgicalinstrument, to the articulated ends of the end-effector of the instrument itself.

[0016] . To electrically insulate such articulating ends of the active electrosurgical instrument, insulating sleeves are typically fitted onto the end-effector, so as to form an electrically insulating barrier with respect to the patient's tissue near or in contact with the end -effector itself.

[0017] . For example, prior art document US-2019-0314108 shows an insulating sleeve solution comprising a conductive ring for putting two sections of an electrical wire which are mounted in the surgi cal instrument in communication . In particular, the conductive ring provided on the insulating sleeve has the function of achieving , only when the sleeve is fitted in the correct position on the surgical instrument, the electrical continuity between such two sections of electrical wire, therefore acting as a safety device which interrupts the circuit when not in the correct position.

[0018] . Particularly in the known electro-cauterizing applications in laparoscopy, it is very important to avoid transmitting electri cal energy at the fulcrum point, i.e. , at the insertion point of the surgical instrument in the dedicated hole thereof, a fulcrum point which when in operating conditions represents the center of rotation of the positioning rod or shaft with respect to the patient. For these reasons, the rod itself is made of electrically insulating material.

[0019] . In fact, in monopolar electrosurgical instruments, an electrical cable is typically provided, which extends into the positioning rod or shaft of the surgical instrument from the transmission interface portion to the articulated wrist.

[0020] . Otherwise, in bipolar electrosurgical instruments the two tips of the instrument are polarized with a different charge, such as to form two electrodes, one of which forms the return electrode. In this type of electrosurgical instruments, it is necessary to avoid short circuits between the various parts of the end-effector which have a different electrical charge (for example between the two tips as well as between the respective electric conductor cables) .

[0021] . Therefore, the use of electrically insulating sleeves has the purpose of both avoiding short circuits (bipolar instruments) and avoiding involuntary supplies of electrical energy (both mono - and bipolarinstruments).

[0022] . In the known solutions of both electrosurgical and non -surgical instruments, the problem of providing effective protection to the surgical instrument while allowing a wide freedom of movement of the instrument itself remains open.

[0023] . Solution

[0024] . 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.

[0025] . This and other objects are achieved by a surgical instrument according to claim 1 .

[0026] . Some advantageous embodiments are the subject of the dependent claims.

[0027] . According to an aspect of the invention, a surgical instrument for robotic surgery and / or microsurgery comprises a proximal portion and a distal portion which is movable with respect to the proximal portion , and at least one joint of motion between the proximal portion and the distal portion .

[0028] . The surgical instrument further comprises a flexible sleeve fitted onto the at least one joint of motion , said flexible sleeve comprising flexible body, adapted to deform to conform to various operating configurations of the at least one joint of motion.

[0029] . The flexible sleeve comprises at least one electrically insulating portion and at least one electrically conductive path , said at least one electrically conductive path comprising a proximal contact located proximal to said at least one joint of motion and a distal contact located distal to said joint of motion of the surgical instrument, and a flexible electric conductor extended from the proximal contact to the distal contact.

[0030] . The flexible electric conductor is between the electrically insulating portion of the flexible sleeve and the at least one joint of motion of the surgical instrument, and the distal contact is in communication of electric conduction with the distal portion of the surgical instrument.

[0031] . In accordance with an embodiment, the distal contact is in communication of electric conduction with an operating portion of the surgical instrument.

[0032] . The operating portion can comprise: an electrode to supplycauterizing electrosurgical energy, and / or a sensor which detects position and / or orientation of the at least one joint of motion and / or the distal portion of the surgical instrument, and / or a sensor to detect the temperature of the surgical instrument and / or workspace, and / or a vision system , for exam ple an endoscope and / or a camera, and / or a visible light emitter, and / or a radiofrequency and / or ultrasound energy emitter, and / or a data transfer emitter.

[0033] . The distal contact of the electrically conductive path of the flexible sleeve can itself form the di stal portion of the surgical instrument.

[0034] . The proximal contact can be in contact with the proximal portion of the surgical instrument. In accordance with an embodiment, the proximal portion of the surgical instrument comprises a rigid positioning rod or sti ck or shaft.

[0035] . The at least one joint of motion can comprise a rotational joint, for example a pin joint.

[0036] . The at least one electrically conductive path can comprise conductive particulate, e.g . , comprising carbon micro- and / or nanostructures, such as carbon nanotubes, dispersed within a polymeric matrix, e.g . , silicone rubber.

[0037] . The at least one electrically conductive path can comprise an electric conductor, preferably a metal wire such as a copper wire, and / or stranded metal wires.

[0038] . The at least one electrically conductive path can comprise a flexible printed circuit.

[0039] . The at least one electrically conductive path can comprise a conductive plate, for example made of carbon fiber with cuts to make it flexible.

[0040] . In accordance with an embodiment, the flexible electric conductor of the at least one electrically conductive path describes a tortuous and / or inclined path with respect to the longitudinal development direction of the flexible sleeve to maintain the electric conductivity also when the path and / or the flexible sleeve are locally overextended.

[0041] . In accordance with an embodiment, the electrically insulating portion of the flexible sleeve is made of silicone rubber.

[0042] . In accordance with an embodiment, the flexible sleevecomprises two electrically conductive paths, including said at least one conductive path , and wherein the two electrically conductive paths are separated and disjointed from one another for the entire extension of the flexible sleeve. In such a case, preferably, the distal portion of the surgical instrument comprises two electrodes, each electrode being in communication of electric conduction with a single respective electrically conductive path , thus forming a bipolar electrosurgical instrument.

[0043] . Brief description of the figures

[0044] . 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” e mbodiment 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 in the figure can be necessary for a certain embodiment.

[0045] . Figure 1 -A is an axonometric view of a robotic system for surgical or microsurgical teleoperation , according to an embodiment;

[0046] . Figure 1 -B is an axonometric view of a surgical instrument, according to an embodiment.

[0047] . Figure 2-A is a diagrammatic view of a robotic system for surgical or microsurgical teleoperation , according to an embodiment.

[0048] . Figure 2-B is a diagrammatic view of a robotic system for surgical or microsurgical teleoperation , according to an embodiment.

[0049] . Figures 3-A and 3-B are vertical elevation views pictorially depicting a surgical instrument, according to some embodiments.

[0050] . Figure 3-C is a vertical elevation view of a surgical instrum ent showing , in longitudinal section, a flexible sleeve fitted onto the surgical instrument.

[0051] . Figures 4-A and 4-B are vertical elevation views pictorially depicting a surgical instrument, according to some embodiments.

[0052] . Figures 5-A and 5-B are axonometric views showing a surgical instrument, according to some embodiments.

[0053] . Figures 5-C and 5-D are longitudinal section views of a portion of a flexible sleeve, according to some embodiments.

[0054] . Figure 5-E is a cross-section view of a flexible sleeve, according to an embodiment.

[0055] . Figure 6-A shows an axonometric view of a surgical instrument, according to an embodiment.

[0056] . Figures 6-B, 6-C and 6-D are longitudinal section views of a portion of a flexible sleeve, according to some embodiments.

[0057] . Figure 6-D shows an axonometric view of a surgical instrument, according to an embodiment

[0058] . Figures 6-F, 6-G, 6-H, 6- 1 , 6-J, and 6-K are axonometric views pictorially showing a flexible sleeve, according to some embodiments.

[0059] . Figure 7-A shows an axonometric view of a surgical instrument, according to an embodiment.

[0060] . Figure 7-B shows in longitudinal section a portion of the flexible sleeve of the surgical instrument in Figure 7-A.

[0061] . Figure 8 is a vertical elevation view of a surgical instrument showing , in longitudinal section, a flexible sleeve fitted onto the surgical instrument.

[0062] . Figure 9 is a longitudinal section view of a portion of a flexible sleeve, according to an embodiment.

[0063] . Figures 1 0-A, 10-B, 1 0-C, 1 0-D, 10-E, 10-F, and 10-G are longitudinal section views of a portion of a flexible sl eeve, according to some embodiments.

[0064] . Figures 1 1 -A and 1 1 -B are axonometric views showing a surgical instrument, according to some embodiments.

[0065] . Figure 1 2 shows in axonometric view a surgical instrument, according to an embodiment.

[0066] . Figure 13 shows in axonometric view a surgical instrument, according to an embodiment.

[0067] . Figures 14-A, 14-B and 1 5 show in partial longitudinal section a flexible sleeve, according to some embodiments.

[0068] . Figure 1 6 is a section view of an injection molding mold, according to an embodiment.

[0069] . Figure 17-A is an axonometric view of a portion of a mold for dip molding , according to an embodiment.

[0070] . Figure 1 7-B shows in vertical elevation a detail of the mold portion in Figure 1 7-A.

[0071] . Detailed description of some embodiments

[0072] . 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 embod iment” in various parts of this description do not necessarily all refer to the same embodiment. Moreover, particular features, structures or functions such as those shown in different drawings can be combined in any suitable manner in one or more embodiments.

[0073] . In accordance with a general embodiment, a surgical instrument 1 for robotic surgery comprises a proximal portion 2 and a distal portion 3 which is movable with respect to the proximal portion 2, and at least one joint of motion 4 between the proximal portion 2 and the distal portion 1 .

[0074] . Preferably, the surgical instrument 1 belongs to a robotic system 5 for surgical or microsurgical teleoperation. In accordance with an embodiment, as shown for example in Figure 1 -A, the robotic system 5 for surgical teleoperation comprises two surgical instruments 1 which are removably mounted to two respective robotic manipulators 6 operable under the control of a master console (not shown) .

[0075] . As shown for example in Figure 1 -B, the surgical instrument 1 can comprise a positioning rod or shaft 26 having an articulated wrist at the distal end thereof , said positioning rod or shaft 26 extending from a transmission interface portion 30 or backend 30.

[0076] . In accordance with an embodiment, as shown for example in Figures 2-A and 2-B, the surgical instrument 1 is an electrosurgical instrument 1 and the robotic system 5 for surgical teleoperation further comprises a pedal control 7 for activating the supply of radiofrequency electrical energy for the electrosurgical instrument 1 and a generator 8 for generating radiofrequency current which is operatively connected between the pedal control 7 and the electrosurgical instrument 1 .

[0077] . The surgical instrument 1 further comprises a flexible sleeve 1 0fitted onto the at least one joint of motion 4, said sleeve 1 0 comprising a flexible body, adapted to deform to conform to various operating configurations of the at least one joint of motion 4 of the surgical instrument 1 .

[0078] . Advantageously, said flexible sleeve 10 comprises at least one electrically insulating portion 1 1 and at least one electrically conductive path 20.

[0079] . The flexible sleeve 1 0 preferably comprises a proximal opening 14 and a distal opening 15, making a longitudinally directed inner through channel 13, for housing at least the rotational joint 4 of the surgical instrument. The proximal opening 14 of the flexible sleeve 10 can be delimited by a proximally longitudinally facing proximal opening edge 1 6. For example, said proximal edge 1 6 is made by the thickness of the body of the flexible sleeve 1 0. The distal opening 1 5 of the flexible sleeve 1 0 can be delimited by a distal opening edge 1 7 facing radially internally, i.e. , in the internal radial direction RL For example, said distal edge 1 7 is also made by the thickness of the body of the flexible sleeve 1 0.

[0080] . In accordance with another embodiment, the flexible sleeve 10 forms a cap 10 having a closed distal end 1 8 which lacks through holes. In such a case, the closed distal end 1 8 of the flexible sleeve (cap) 10 can comprise the distal contact 23 exposed outside the cavity 13, in the distal direction .

[0081] . Preferably, the flexible sleeve 10 is also extensible radially externally RO, so that it deforms when fitted onto the surgical instrument 1 , remaining close-fitting , i.e. , adhered, to the surgical instrument due to the elasticity thereof.

[0082] . The distal portion 3 of the surgical instrument 1 can comprise a free end of the surgical instrument 1 , for example a tip 24, 25 of the surgical instrument 1 .

[0083] . As shown for example in Figure 3-A, the distal portion 3 can comprise two jaws 24, 25 or tips 24, 25 movable in opening / closing OP / CL and which can be both constrained in a joint of motion 4 which is a rotational joint, and the proximal portion 2 can be a distal section of the rigid positioning rod or shaft; the flexible sleeve 1 0 is fitted onto the rotational joint exposing the tips 24, 25 or jaws 24, 25 outside the flexible sleeve 1 0itself ; at least one conductive path 20 can be embedded in the portion of electrically insulating body 1 1 to put in communication of electric conduction the distal portion 27 of the rod 26 or shaft and the tips 24, 25 or jaws 24, 25. In this case, the surgical instrument 1 can be an electrosurgical instrument 1 of the type adapted to supply cauterizing electrical energy by means of the distal portion 3 thereof, which comprises at least one tip or jaw 24, 25, for example.

[0084] . As shown for example in Figure 3-B, the distal portion 3 can comprise two jaws 24, 25 or tips 24, 25 movable in opening / closing OP / CL and the at least one joint of motion 4 can comprise a rotational joint for the jaws or tips and also a flexible section 28 of the positioning rod or shaft 26 as a distal section 27, for example a section comprising a plu rality of stacked vertebrae ("snake", "flexible robotics") ; the flexible sleeve 10 is fitted onto the flexible section of the positioning rod or shaft 26 which acts as a joint of motion 4; the at least one conductive path 20 of the flexible sleeve 1 0 extends along the flexible section 28 of the positioning rod or shaft 26 putting in communication of electric conduction a rigid section 29 of the positioning rod or shaft and the jaws 25, 26 or tips 25, 26.

[0085] . As shown for example in Figure 3-C, the distal portion 3 can comprise a single tip 24, i.e. , a single link 24 and the joint of motion 4 can comprise an articulated wrist which includes two rotational joints with mutually orthogonal axis (e.g . , "pitch -yaw") ; the flexible sleeve 1 0 is fitted onto the articulated wrist and the at least one conductive path 20, putting in communication of electric conduction the distal portion 27 of the positioning rod or shaft 26, in this case rigid, with the single distal tip 24. In this case, the surgical instrument is preferably an electrosurgical instrument 1 of the monopolar type. In accordance with another embodiment, the surgical instrument 1 comprises a sensor and / or a camera and / or a light emitter (e.g ., LED) on the distal portion 3 thereof in communication of electric co nduction with the proximal portion 2 by providing said flexible sleeve 1 0 with the at least one conductive path 20 thereof .

[0086] . The at least one conductive path 20 preferably extends generally longitudinally with respect to the surgical instrument 1 , i.e. , proxi m al ly-d i stal ly . In other words, the flexible electric conductor 21 of the at least one conductive path 20 extends in a generally longitudinal directionfrom the proximal contact 22 to the distal contact 23, in which the longitudinal direction is to be understood as the longitudinal development direction of the surgical instrument in the section where the at least one joint of motion 4 is present.

[0087] . The at least one joint of motion 4, as said, can comprise a rotational joint and / or a flexible portion ("snake", vertebrae) and preferably the at least one rotational joint is actuated by providing at least one actuation tendon 1 9. The at least one actuation tendon 1 9 can be made of polymeric material, or of metallic material .

[0088] . Where the at least one actuation tendon 1 9 is made of polymeric material, for example a strand of braided polymeric fibers, and the surgical instrument 1 is an electrosurgical instrument for supplying cauterizing electrical energy from the distal portion thereof, the flexible sleeve 1 0 can be fitted in a fluid-tight manner onto the at least one joint of motion 4 actuated by actuation tendons 19 to avoid or at least minimize the possibility of fumes and vapors generated during electrosurgical action penetrating inside the flexible sleeve 10 itself, with potential damage to the polymeric tendons 1 9.

[0089] . The at least one joint of motion 4 can itself be made of electrically conductive material, such as metal, and therefore already be capable of placing the distal portion 27 of the positioning rod or sh aft 26 and the at least one distal end tip 24 thereof in communication of electric conduction ; however, the provision of moving parts such as pin joints and / or stacked vertebrae which necessarily provide mechanical clearance, even if minimal, reduces the conductivity at such moving parts and therefore the provision of the at least one conductive path 20 in the flexible sleeve 10 allows obtaining satisfactory and repeatable and reliable conductivity.

[0090] . As shown for example in Figure 4-A, the at least one joint of motion 4 can be a flexible section 28 of the positioning rod or shaft 26 interposed longitudinally between two sections 29 of the same positioning rod or shaft which are rigid ; the provision of the flexible sleeve 1 0 with the at least one conductive path 20 thereof allows the two rigid sections of the rod or shaft to be arranged in communication of electric conduction . As shown for example in Figure 4-B, the at least one joint of motion 4 can be an articulated section of the positioning rod or shaft 26 interposedlongitudinally between two sections of the same positioning rod or shaft which are rigid, said articulated section comprising for example two rotational joints with parallel axes.

[0091] . The at least one joint of motion 4 can provide a degree of freedom of rolling or twisting around a definable longitudinal direction between the proximal portion 2 and the distal portion 3 of the surgical instrument.

[0092] . The insulating portion 1 1 of the flexible body of the sleeve 1 0 can be made of silicone (silicone rubber) or other suitable material and is preferably provided above, i.e. , outside the at least one conductive path 20 of the same sleeve 10. As mentioned above, the at least one conductive path 20 is designed to arrange in communication of electric conduction a proximal section 2 of the instrument with a distal section 3 of the same instrument, crossing at least one joint of motion 4, whereby preferably the at least one conductive path 20 of the flexible sleeve 1 0 is insulated, i.e. , covered by the insulating material 1 1 .

[0093] . The at least one electrically conductive path 20 of the flexible sleeve 10 comprises a proximal contact 22, located proximal with respect to said at least one joint of motion 4 of the surgical instrument 1 , and a distal contact 23, located distal with respect to said at least one joint of motion 4 of the surgical instrument 1 , and a flexible electric conductor 21 extended from the proximal contact 22 to the distal contact 23. It is therefore possible to make a conductive path inside the body of the flexible insulating sleeve which crosses the joint of motion 4 of the surgical instrument, ensuring a certain electric conduction even where the joint of motion requires the presence of mechanical clearance which locally decreases the electric conductivity of the joint of motion itself. In other words, a preferential path for the electric current is made which is incorporated inside the flexible body of the insulating sleeve, providing certainty of electric conduction.

[0094] . Furthermore, the flexible electric conductor 21 is between the electrically insulating portion 1 1 of the flexible sleeve 1 0 and the at least one joint of motion 4 of the surgical instrument 1 . In other words, transversely or radially R-R with respect to the longitudinal direction of the surgical instrument, the flexible electric conductor 21 of the conductive path 20 of the flexible sleeve 1 0 is interposed between the electrically insulatingportion 1 1 of the sleeve 10 itself and the surgical instrument 1 , and in particular the at least one joint of motion 4 of the surgical instrument 1 .

[0095] . With further advantage, the distal contact 23 of the path 20 of the flexible sleeve 1 0 is in communication of electric conduction with the distal portion 3 of the surgical instrument 1 .

[0096] . In accordance with a preferred embodiment, the distal portion 3 of the surgical instrument 1 - which can comprise as said one or more tips or jaws 24, 25 movable in opening closing OP / CL and / or a single electrode for supplying cauterizing electrical energy and / or a sensor and / or a camera and / or a light - is made at least partially of electrically conductive material, such as metal. The section of the surgical instrument 1 protected by the flexible sleeve 10 and comprising said at least one rotational join t 4 is not necessarily made of electrically conductive material. For example, an electrically insulating element, such as a link and / or a vertebra of the instrument can be provided to insulate the distal portion 3 of the instrument from the proximal portion 2, in the absence of said conductive path 20 of the flexible sleeve 1 0.

[0097] . In accordance with another embodiment, as shown for example in Fig ure 8, the distal contact 23 of the conductive path 20 of the flexible sleeve 1 0 itself forms the distal portion 3 of the surgical instrument 1 , and preferably forms an electrode for supplying cauterizing electrical energy. Said supply electrode formed by the distal contact 23 can be in the form of a metal ring exposed outside the body of the flexible sleeve 1 0 and / or a metal cap or dome. In particular, Figure 8 also shows at least one joint of motion 4 within the flexible sleeve 10 which is not in communication of electric conduction with the distal contact 23, but is electrically insulated therefrom, in which the at least one joint of motion 4 repositions and / or reorients the distal portion 3 of the instrument.

[0098] . The positioning rod or shaft of the surgical instrument 1 can comprise an electrically conductive body and the proximal contact 22 of the conductive path 20 of the flexible sleeve 1 0 is preferably in contact with an electrically conductive portion of the positioning rod or shaft 26 in the proximal section 2 of the surgical instrument 1 .

[0099] . The at least one flexible electric conductor 21 of the at least one electrically conductive path 20 of the flexible sleeve 10 can be made invarious manners.

[0100] . As shown for example in Figures 5-A and 5-B, the flexible sleeve 10 can comprise an electrically conductive path 20 made in the form of conductive particulate embedded in a polymeric matrix. Preferably, the polymeric matrix in which the conductive particulate is embedded is made of the same material as the electrically insulating portion 1 1 of the same flexible sleeve 1 0, for example silicone rubber (polydimethylsiloxane, or PDMS) . The conductive particulate can comprise carbon nano -tubes dispersed in said silicone matrix. Therefore, the flexible electric conductor 21 of the conductive path 20 of the flexible sleeve 10 can be formed by said conductive particulate dispersed in the polymeric matrix.

[0101] . As shown for example in Figure 5-C, the conductive path 20 can be arranged internally with respect to the external insulating material 1 1 and facing the surgical instrument 1 , forming the proximal contact 22 with a proximal section thereof, the distal contact 23 with a distal section thereof and the flexible conductor 21 with an intermediate section thereof.

[0102] . As shown for example in Figure 5-D, the conductive path 20 and in particular the flexible conductive section 21 thereof can be interposed radially R-R or transversely R-R between two layers 1 1 and 1 2 of insulating material, while the proximal 22 and distal 23 contacts can be made by exposing the conductive path 20, for example by removing a portion of the inner insulating layer 1 2.

[0103] . As shown for example in Figure 5-E, the flexible sleeve 10 can comprise an outer insulating layer 1 1 and two conductive paths 20 in conductive particulate dispersed in polymeric matrix arranged radially internally Rl with respect to the outer radial insulating layer 1 1 . Preferably, the outer insulating layer 1 1 of the flexible sleeve 10 is also stretchable radially R-R so that when fitted onto the at least one joint of motion 4 of the surgical instrument 1 it can expand radially internally Rl around the conductive paths 20. The flexible sleeve 10 can thus be manufactured by depositing the insulating material 1 1 and the conductive particulate in two successive castings, avoiding casting insulating material circumferentially between two conductive paths in conductive particulate. In other words, in the circumferential direction C-C the in ner layer of the flexible sleeve 1 0 can comprise empty spaces between the conductive paths 20 which arefilled in use due to the inner radial deformation Rl of the body of the outer insulating layer 1 1 of the flexible sleeve 10. For casting the conductive paths 20 in particulate, a shaped core can be used which confines the conductive paths in a circumferential direction C-C.

[0104] . As shown for example in Fig ure 6-A, the flexible electric conductor 21 of the at least one conductive path 20 of the flexible sleeve 10 can be made of an electrically conductive metal wire, strand or strip, for example made of copper and / or gold. Preferably, in this case, the insulating material of the flexible sleeve 10 is cast into a mold or shape in which the flexible electric conductor 21 is previously placed. The proximal and distal contacts 22, 23 can be formed by metal rings in contact with the flexible conductor 21 . In such a case, the rings can also be placed in the mold or shape before casting the insulating material 1 1 (e.g . , silicone rubber or polydimethylsiloxane PDMS) . The proximal contact 22 and / or the distal contact 23 can be exposed by the insulating body of the flexible sleeve 1 0 radially internally and / or radially externally and / or longitudinally in the proximal or distal direction, respectively. The silicone rubber can be made by polyaddition of two components.

[0105] . As shown for example in Figure 6-B, the radially inner portion of the flexible sleeve 10 can comprise the electrically conductive path 20 formed by said flexible electric conductor 21 , which in turn forms the proximal contact 22 with a proximal section thereof and the distal contact 23 with a distal section thereof .

[0106] . As shown for example in Fig ure 6-C, the flexible electric conductor 21 can be radially interposed between two layers 1 1 , 12 of insulating material, in which the proximal and distal contacts 22, 23 can be made in the form of conductive rings.

[0107] . The proximal and / or distal contacts 22, 23 are not necessarily exposed radially outside the body of the flexible sleeve 10 and, in accordance with an embodiment as shown for example in Figure 6-D, the distal contact 23 can be formed by a conductive ring which is exposed radially internally and longitudinally in the distal direction .

[0108] . As shown for example in Figure 6-E, the flexible conductor 21 of the conductive path 20 can be made with a wire or tape or strip having a tortuous path comprising a plurality of folds. The provision of a tortuouspath allows maintaining a satisfactory conductivity between the proximal contact and the distal contact 23 even if at least one portion of the flexible body of the sleeve 1 0 is overextended.

[0109] . As shown for example in Figure 6-F, the flexible conductor 21 can extend substantially spirally or helically around a definable longitudinal axis of the flexible sleeve 10.[001 10]. As shown for example in Figures 6-G and 6-H, the flexible conductor 21 can be formed by a conductive plate or strip in which cuts are made to confer flexibility. The cut plate or strip can comprise one or more sheets of carbon nanotubes. Alternatively or in addition , the conductive plate or strip can be made of sheet metal or metal foil, for example copper, gold, or the like.[001 11 ]. As shown for example in Figure 6-I, an armature of conductive material can be provided, comprising two rings to form the proximal and distal contacts 22, 23 and a plurality of flexible conductors extended therebetween .[001 12]. The conductive path 20 is not necessarily exposed in the longitudinal direction (distally and / or proximally) outside the body of the flexible sleeve 10.[001 13]. As shown for example in Figure 6-J, the conductive path 20 can comprise one or more data transmission paths.[001 14]. As shown for example in Figure 6-K, the conductive path 20 can comprise a mesh body formed by conductive elements braided with each other, in the same way as a stent. The proximal 22 and distal 23 contacts can be made by exposing the mesh body radially internally, for example.[001 15]. As mentioned above, the distal opening 1 5 of the flexible sleeve can be contoured by the distal contact 23 of the path 20, or the distal opening 15 can be arranged more distally with respect to the distal contact 23, which in such a case can be exposed radially internally in contact wi th the distal portion 3 of the surgical instrument.[001 16]. The proximal opening 14 of the flexible sleeve 1 0 can be contoured by the proximal contact 22 of the path 20, or the proximal opening 14 can be arranged more proximally with respect to the proximal contact 22, which in such a case can be exposed radially internally and / or radially externally of the flexible sleeve body.[001 17]. In accordance with an embodiment, the proximal contact 22 is exposed radially externally, for example by a hole in the outer insulating layer 1 1 of the sleeve itself, forming a sort of port or plug , and is designed to receive an electric conductor, such as an electrical wire.[001 18]. As shown for example in Figure 7-A, the conductive path 20 can comprise a flexible conductor 21 made as conductive particulate and the proximal and distal contacts 22, 23 made as rings of rigid metallic material. In such a case, as shown for example in Figure 7-B, the flexible conductor 21 comprising conductive particulate can extend radially interposed between two layers 1 1 , 1 2 of electrically insulating material.[001 19]. Preferably, the at least one conductive path 20 is made integral with the insulating portion 1 1 , 1 2 of the flexible sleeve 10. In other words, when in use, there is no relative local displacement between the at least one conductive path 20 and the insulating portion of the flexible sleeve.

[0120] . In accordance with another embodiment, as shown for example in Figure 9, longitudinal clearance is provided between the at least one conductive path 20 and the insulating mate rial 1 1 , 1 2 of the flexible sleeve 10, i.e. , in other words the at least one conductive path 20, and in particular at least the flexible conductor 21 , is capable of sliding locally longitudinally with respect to the insulating portion 1 1 , 1 2 of the flexibl e sleeve 10. In such a case, an elastic element KE can be provided, which is capable of achieving a preload aimed at keeping the flexible conductor 21 taut. To achieve the preload, the distal contact 23 can act as an end-of-stroke.

[0121] . As shown for example in Figure 10-A, in accordance with an embodiment the proximal contact 22 is longitudinally exposed outside the proximal opening edge 16, i.e. , is longitudinally exposed by the thickness of the body of the flexible sleeve 1 0. In such a case, the distal contact 23 can be exposed radially internally before the distal opening 15. In accordance with another embodiment, as shown for example in Figure 10- B, the distal contact 23 is exposed outside the distal opening edge 17, i.e. , it is exposed radially internally through the thickness of the sleeve at the distal opening .

[0122] . As shown for example in Figure 10-C, in accordance with an embodiment, the proximal and distal contacts are both exposed radially internally but offset longitudinally with respect to the proximal and distalopenings. In accordance with another embodiment, as shown for example in Figure 10-D, the distal contact is exposed radially internally at the distal opening edge 1 7.

[0123] . As shown for example in Figure 10-E, a conductive path 20 comprising conductive particulate can be provided, which is entirely exposed in the inner radial direction Rl and which itself forms both the proximal contact 22 and the distal contact 23.

[0124] . The surgical instrument 10 is preferably an electrosurgical instrument, in which the distal portion 3 thereof comprises at least one electrode for supplying electrical energy.

[0125] . The electrosurgical instrument can be of the monopolar type or of the bipolar type.

[0126] . If the electrosurgical instrument is of the bipolar type, then two separate conductive paths are preferably provided in the flexible body of the sleeve 1 0, in which one conductive path serves as a forward path to the distal portion 3 and the other separate conductive path serves as a return path from the distal portion to the proximal contact 22. Alternatively, where the electrosurgical instrument is of the bipolar type, a single conductive path can be provided in the flexible sleeve 10, which for example serves as a forward path to the distal portion 3, and the other return conductive path can be formed by another conductor.

[0127] . In accordance with an embodiment, as shown for example in Figures 11 -A and 1 1 -B, the electrosurgical instrument 1 is of the bipolar type, in which the distal portion 3 comprises two tips 24 and 25 serving as a forward electrode and a return electrode, respectively, and in which the flexible body of the sleeve 10 comprises two separate conductive paths 20 and 20’. I n this case, the flexible sleeve 10 comprises two proximal contacts 22 and 22’ and two distal contacts 23 and 23’.

[0128] . In accordance with an embodiment, as shown for example in Figure 12, the electrosurgical instrument 1 is of the bipolar type and the proximal 22, 22’ and distal 23, 23’ contacts are made of rigid conductive elements, for example metal rings while the conductors 21 and 21 ’ therebetween are made of conductive particulate.

[0129] . In accordance with an embodiment, as shown for example in Figure 13, the electrosurgical instrument 1 is of the bipolar type, and theproximal contacts 22 and 22’ are formed by conductive plugs.

[0130] . A method for manufacturing a flexible sleeve 1 0 will be described below.

[0131] . In accordance with a general manufacturing form, a method for manufacturing a flexible sleeve 10 for a surgical instrument 1 comprising the following steps of :

[0132] . - providing an injection molding mold 40 comprising a male element 42 i.e. , a tubular core 42 and a female element 43 ;

[0133] . - arranging electrically conductive material on the male element42 ;

[0134] . - assembling the female element 43 to the male element 42 of the mold 40, creating a mold cavity 41 between the male element and the female element, in which the electrically conductive material is in the mold cavity 41 ;

[0135] . - casting and / or injecting flexible material, e.g . , silicone rubber or PDMS, into the mold cavity 41 .

[0136] . To make a multi-layer sleeve, a plurality of male elements of different sizes which are progressively associated with a single female element can be included, or a plurality of female elements of different sizes which are progressively associated with a single male element can be included.

[0137] . A method for manufacturing a flexible sleeve 1 0 will be described below.

[0138] . In accordance with a general manufacturing form, a method for manufacturing a flexible sleeve 10 for a surgical instrument 1 comprising the following steps of :

[0139] . - providing a tubular core 42 for dip molding ;

[0001] . - dipping the tubular core 42 in a polymeric matrix with or without dispersed conductive particulate.

[0002] . The method can further comprise the step of preheating the tubular core and / or the step of cutting the distal end of th e solidified polymeric matrix once separated from the tubular core, so as to make a distal opening of the flexible sleeve 1 0. The polymeric matrix with or without conductive particulate can be contained in a tank (not shown), in which the tank lid 44 can comprise a plurality of tubular cores 42 extendingcantilevered therefrom to immerse in the tank so as to make a plurality of flexible sleeves at a time, favoring the mass production of the flexible sleeve.

[0003] . 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:

[0004] . - it allows one or more conductive paths to be integrated in the flexible body of the sleeve which is fitted onto a joint of motion of the surgical instrument;

[0005] . - an adequate insulation of the one or more conductive paths is also achieved by including at least one layer of dielectric material (electrically insulating) outside the one or more paths;

[0006] . - it is therefore possible to ensure a satisfactory electric conductivity even at a joint of motion which typically comprises movable parts and clearances, albeit minimal, resulting in uncertainty of conductivity when in various operating configurations;

[0007] . - the surgical instrument 1 is preferably an electrosurgical instrument 1 and the flexible sleeve 1 0 with the at least one conductive path 20 thereof acts as an electric conductor to carry current to the one or more electrodes of the electrosurgical instrument.

[0008] . It is well understood that the combinations of features disclosed in the appended claims form an integral part of the present disclosure.

[0009] . In order to meet specific, contingent needs, those skilled in the art may make several changes and adaptations to the above-described embodiments and can replace elements with others which are functionally equivalent, without departing from the scope of the appended claims.LIST OF REFERENCE SIGNS1 Surgical or microsurgical instrument 2 Proximal portion of the surgical instrument 3 Distal portion of the surgical instrument 4 Joint of motion of the surgical instrument 5 Robotic system for surgical or microsurgical teleoperation 6 Robotic manipulator 7 Pedal control 8 Generator 10 Flexible sleeve of the surgical instrument 11 Electrically insulating portion or layer of the sleeve 12 Electrically insulating inner layer of the sleeve 13 Longitudinal through cavity 14 Proximal opening of the sleeve 15 Distal opening of the sleeve 16 Proximal opening edge 17 Distal opening edge 18 Closed distal end 19 Actuation tendons20, 20’ Conductive path of the flexible sleeve21, 21’ Flexible electric conductor of the path22, 22’ Proximal contact of the path23, 23’ Distal contact of the path 24 Tip or jaw 25 Tip or jaw 26 Positioning rod or shaft 27 Distal portion of the rod or shaft 28 Flexible portion of the rod or shaft 29 Rigid portion of the rod or shaft 30 Transmission interface portion or backend 40 Mold for injection molding 41 Mold cavity 42 Male element or tubular core 43 Female element 44 Mold lid for dip moldingDISTAL Distal directionRO Outer radial direction Rl Inner radial direction KE Elastic element Y Degree of freedom of orientation of the distal portion of the instrument OP / CL Degree of freedom of opening / closing

Claims

CLAIMS1. Surgical instrument (1 ) for robotic surgery and / or microsurgery comprising :- a proximal portion (2) and a distal portion (3) that is movable with respect to the proximal portion ;- at least one joint of motion (4) between the proximal portion and the distal portion ;- a flexible sleeve ( 10) that is fit onto the at least one joint of motion (4), said flexible sleeve comprising flexible body, suitable to deform to conform to various operating configurations of the at least one joint of motion ; wherein :-said flexible sleeve ( 10) comprises at least one electrically insulating portion ( 1 1 ) and at least one electrically conductive path (20) ; and wherein said at least one electrically conducti ve path (20) comprises: -a proximal contact (22) , located proximal to said joint of motion (4) of the surgical instrument;- a distal contact (23), located distal to said joint of motion (4) of the surgical instrument;- a flexible electric conductor (21 ) extended from the proximal contact to the distal contact; and wherein :- the flexible electric conductor (21 ) is between the electrically insulating portion (1 1 ) of the flexible sleeve ( 1 0) and the at least one joint of motion (4) of the surgical instrument;-the distal contact (23) is in communication of electric conduction with the distal portion (3) of the surgical instrument.

2. Surgical instrument according to claim 1 , wherein the distal contact (23) of the flexible sleeve (1 0) forms itself the distal portion (3) of the surgical instrument.

3. Surgical instrument according to claim 1 or 2, wherein the proximal contact (22) is in contact with the proximal portion (2) of the surgical instrument; and wherein, preferably, the proximal portion (2) of the surgical instrument comprises a positioning shaft or stick or beam that is rigid.

4. Surgical instrument according to any one of the preceding claims, wherein the at least one joint of motion comprises a rotational joint, such as a pinjoint; and wherein , preferably, the at least one rotational joint comprises an articulating wrist having two pin joints with mutually orthogonal axis.

5. Surgical instrument according to any one of the preceding claims, wherein the at least one electrically conductive path co mprises at least one of the following :-conductive particulate, such as comprising carbon micro - or nanostructures, such as carbon nanotubes, dispersed within a polymeric matrix, such as silicone rubber; and / or-an electric conductor, preferably a metal wire such as a copper wire, and / or stranded metal wires ; and / or-a flexible printed circuit; and / or- a conductive plate, for example made of carbon fiber with cuts to make it flexible.

6. Surgical instrument according to any one of the preceding claims, wherein the flexible electric conductor (21 ) of the at least one electrically conductive path (20) describes a tortuous path and / or an inclined path with respect to the direction of longitudinal development of the flexible sleeve (1 0) to maintain the electric conductivity also when the path and / or the flexible sleeve are locally overextended.

7. Surgical instrument according to any one of the preceding claims, wherein the proximal contact (22) and / or the distal contact (23) is made of a metal ring , or a portion thereof , arranged around the proximal portion and / or the distal portion, respectively, of the surgical instrument.

8. Surgical instrument according to any one of the preceding claims, wherein the electrically insulating portion of the flexible sleeve ( 1 0) is made of silicone rubber.

9. Surgical instrument according to any one of the preceding claims, wherein the distal contact is in communication of electrical conduction with an operating portion of the surgical instrument, said operating portion comprising at least one of :-an electrode to supply electrosurgical cautery energy; and / or- a sensor that detects position and / or orientation of the at least one joint of motion and / or of the distal portion of the surgical instrument; and / or- a sensor to detect temperature of the surgical instrument and / or workspace; and / or- a vision system , such as an endoscope and / or a camera; and / or- a visible light emitter; and / or- an emitter of radiofrequency and / or ultrasound energy such as an emitter to transfer data.

10. Surgical instrument according to any one of the preceding claims, wherein the flexible sleeve (1 0) comprises a distal opening (1 5) , and wherein the distal portion (3) of the surgical instrument is exposed out of the distal opening of the flexible sleeve.11 . Surgical instrument according to any one of the preceding claims, wherein the distal contact (23) is housed within a seat made into the body of the distal portion of the surgical instrument; and wherein , preferably, said seat comprises a notch , a groove, a rib.

12. Surgical instrument according to any one of the preceding claims, wherein the flexible sleeve (1 0) comprises two electrically conductive paths (20, 20’) including said at least one electrically conductive path, and wherein the two electrically conductive paths are disjointed and separated one another for the entire extension of the flexible sleeve; and wherein , preferably, the distal portion (3) of the surgical instrument comprises two electrodes, each electrode being in communicatio n of electrical conductivity with a single respective electrically conductive path, thereby realizing a bipolar electrosurgical instrument.

13. Surgical instrument according to any one of the preceding claims, wherein the size of the flexible sleeve (1 0) i s smaller than the size of the surgical instrument and in particular of the at least one joint of motion, so that the flexible sleeve stretches radially and circumferentially when fit thereto thereby resulting adherent to the body of the surgical instrumen t.

14. Surgical instrument according to any one of the preceding claims, wherein said proximal contact (22) and / or said distal contact (23) comprises: conductive pad and / or conductive site; and / or magnet and / or conductive deposit and / or conductive particulate.

15. Surgical instrument according to any one of the preceding claims, wherein the flexible electric conductor (21 ) of the at least one conductive path (20) extends in a generally longitudinal direction from the proximal contact to the distal contact.

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