A surgical or microsurgical instrument for robotic remote operation comprising a flexible sleeve having at least one electrically conductive passage

Abstract

"Surgical or microsurgical instrument for robotic remote operation comprising a flexible sleeve having at least one electrically conductive passage" A surgical instrument (1) for robotic microsurgery comprising: a proximal portion (2) and a distal portion (3) movable with respect to the proximal portion; at least one motion joint portion (4) between the proximal portion and the distal portion; a flexible sleeve (10) mounted on the at least one motion joint portion (4) - said sleeve comprises a flexible body suitable for deforming to conform to various operational configurations of the at least one motion joint portion -; said flexible sleeve (10) comprises at least one electrical insulating portion (11) and at least one electrically conductive passage (20); and said at least one electrically conductive passage (20) comprises a proximal contact portion (22) located proximal to the at least one motion joint portion (4) of the surgical instrument; a distal contact portion (23) located distal to the motion joint portion (4) of the surgical instrument; and a flexible electrical conductor (21) extending from the proximal contact portion to the distal contact portion; And a flexible electric conductor (21) is located between the electric insulating portion (11) of the flexible sleeve (10) and at least one motion joint portion (4) of the surgical instrument; and a distal contact portion (23) is electrically connected to the distal portion (3) of the surgical instrument, the surgical instrument.

Description

Technology Field

[0001] The present invention relates to the technical field of robotic systems for remote operation of surgery and / or microsurgery.

[0002] In particular, the present invention relates to a surgical instrument comprising a flexible sleeve having at least one electrically conductive passage.

[0003] In addition, the present invention relates to the aforementioned flexible sleeve having at least one electrically conductive passage.

[0004] In addition, the present invention relates to a method for manufacturing the flexible sleeve. Background Technology

[0005] Robotic surgical devices 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 includes a motor-driven placement system (or manipulator) for moving surgical instruments that can be attached distally to it to perform surgical procedures on a patient. The patient typically lies on a surgical bed located in an operating room, and sterility is ensured to avoid bacterial contamination from non-sterile parts of the robotic device within the operating room.

[0006] Generally, known surgical instruments for remotely operated robotic surgery include a proximal interface portion (or, according to terms commonly adopted in the art, a backend portion) having an interface intended to be manipulated by a robotic manipulator, an elongated element such as a rod or shaft, an articulated device (e.g., a robotic wrist), and a manipulative end portion (e.g., a needle driver, scissors).

[0007] In known surgical instruments having an articulating wrist, it is constructed of multiple links moved by multiple tendons (or operating cables). One or more terminal links may have a free end forming the aforementioned operating end and are suitable for handling needles as well as sutures for performing, for example, direct manipulation on the patient's anatomical structure and / or performing anastomoses or other surgical treatments.

[0008] Unlike known surgical instruments including an articulated wrist portion, surgical instruments having a "snake" type articulated device are also known, namely, comprising a plurality of stacked vertebrae that are movable relative to each other by a plurality of operating cables or tendons.

[0009] In fact, in the field of robotic surgery, surgical instruments are components intended to be operated in a sterile environment, and typically a sterile barrier is inserted between the backend of the instrument and the corresponding part of the operating interface; as a result, the robotic manipulator is located in the non-sterile area of ​​the surgical setup. Therefore, motors are usually placed within the manipulator, that is, on the non-sterile side, and the surgical instrument lacks motors.

[0010] For example, documents regarding the same applicant US-10582975 and WO-2018-189721 The present invention discloses various embodiments of surgical instruments for robotic surgery and microsurgery designed to be subject to extreme miniaturization of the articulated wrist portion and, therefore, the manipulative end or end-effector. As the size of the articulated wrist portion actuated by tendons decreases, apparently, the longitudinal shortening or extension of each tendon activates the corresponding angular movement of the wrist portion, which is progressively increasing in size. For example, prior art documents by the same applicant US-2021-106393As shown in [figure], the tendons themselves can be made of polymer material to further reduce the dimensions of the articulating wrist as well as the tendon-articulating wrist sliding friction coefficient.

[0011] The provision of such polymer tendons may impose dedicated control algorithms, which, for example, for the same applicant WO-2022-264078 , WO-2022-264075 , WO-2022-264080 and WO-2023-047300 As illustrated in [figure].

[0012] Types of surgical instruments adapted to transmit electrical energy to tissues, such as electrocauterizing surgical instruments for robotic surgery, are also known. Some known examples of such instruments are found in the prior art documents. US-6840938, US-7824401, US-10376331, US-8398634, US-10716617 , and US-2022-133388 It is depicted in.

[0013] The disclosed electrosurgical instruments typically include one or more conductors for transmitting electrical energy from a robotic manipulator to the articulated ends of the end effectors of the instrument itself, via a transmission interface portion of the surgical instrument.

[0014] To electrically insulate such articulated ends of an active electrosurgical device, insulating sleeves are typically mounted on the end effector to form an electrical insulating barrier against the patient's tissues near or in contact with the end effector itself.

[0015] For example, prior art documents US-2019-0314108The invention provides an insulating sleeve solution comprising a conductive ring for connecting two sections of an electrical wire mounted within a surgical instrument. In particular, the conductive ring provided on the insulating sleeve functions to achieve electrical continuity between two sections of such electrical wire only when the sleeve is mounted in the correct position on the surgical instrument, and consequently acts as a safety device that cuts off the circuit when it is not in the correct position.

[0016] In particular, in known electrocautery applications in laparoscopy, it is very important to avoid transmitting electrical energy at the fulcrum point, that is, at the point of insertion of the surgical instrument into its dedicated opening, where the fulcrum point represents the center of rotation of the rod or shaft placed relative to the patient under operating conditions. For these reasons, the rod itself is made of an electrically insulating material.

[0017] In fact, in monopolar electrosurgical instruments, an electrical cable is typically provided, which extends from the transmission interface portion to the articulated wrist portion into the placement rod or shaft of the surgical instrument.

[0018] Otherwise, in bipolar electrosurgical instruments, the two tips of the instrument are polarized with different charges to form two electrodes, one of which forms the return electrode. In this type of electrosurgical instrument, it is necessary to avoid short circuits between various parts of the end-effector having different electrical charges (e.g., between each electrical conductor cable as well as between the two tips).

[0019] Therefore, the use of electrically insulating sleeves serves the purpose of both avoiding short circuits (positive devices) and avoiding unintended electrical energy supply (both unipolar and positive devices).

[0020] In known solutions for both electrosurgical and non-surgical instruments, the problem of providing effective protection to surgical instruments while allowing wide freedom of movement of the instruments themselves remains open.

[0021] The objective of the present invention is to devise a solution capable of eliminating the defects for which complaints have been raised, by referring to the prior art.

[0022] This and other objectives are achieved by the surgical instrument according to claim 1.

[0023] Some advantageous embodiments are the subject of dependent claims.

[0024] According to one aspect of the present invention, a surgical instrument for robotic surgery and / or microsurgery comprises a proximal portion, a distal portion movable with respect to the proximal portion, and at least one joint of motion between the proximal portion and the distal portion.

[0025] The surgical instrument further comprises a flexible sleeve mounted on the at least one motion joint, and the flexible sleeve comprises a flexible body suitable for deforming to conform to various operating configurations of the at least one motion joint.

[0026] A flexible sleeve comprises at least one electrical insulating portion and at least one electrically conductive passage, wherein the at least one electrically conductive passage comprises a proximal contact portion located proximal to the at least one motion joint portion, a distal contact portion located distal to the motion joint portion of a surgical instrument, and a flexible electrical conductor extending from the proximal contact portion to the distal contact portion.

[0027] The flexible electric conductor is located between the electrical insulation of the flexible sleeve and at least one motion joint of the surgical instrument, and the distal contact communicates of electric conduction with the distal part of the surgical instrument.

[0028] According to one embodiment, the distal contact portion is electrically connected to the operating portion of the surgical instrument.

[0029] The operating unit may include: an electrode for supplying electrosurgical cauterization energy, and / or a sensor for detecting the position and / or orientation of at least one motion joint and / or distal part of a surgical instrument, and / or a sensor for detecting the temperature of the surgical instrument and / or workspace, and / or a visual system such as an endoscope and / or camera, and / or a visible light emitter, and / or a radio frequency and / or ultrasonic energy emitter, and / or a data transmission emitter.

[0030] The distal contact of the electrically conductive passage of the flexible sleeve can itself form the distal part of the surgical instrument.

[0031] The proximal contact portion may contact the proximal portion of the surgical instrument. According to one embodiment, the proximal portion of the surgical instrument includes a rigid placement rod or stick or shaft.

[0032] At least one motion joint may include a rotational joint, such as a pin joint.

[0033] At least one electrically conductive pathway may comprise conductive particles, such as carbon micro- and / or nano-structures, including carbon nanotubes, dispersed within a polymeric matrix, such as silicone rubber.

[0034] At least one electrically conductive passage may comprise an electrical conductor, preferably a metal wire such as a copper wire, and / or a stranded metal wire.

[0035] At least one electrically conductive path may include a flexible printed circuit.

[0036] At least one electrically conductive passage may include, for example, a conductive plate made of carbon fiber that includes a cut to impart flexibility.

[0037] According to one embodiment, a flexible electric conductor of at least one electrically conductive passage forms a slanted and / or inclined passage with respect to the longitudinal development direction of the flexible sleeve in order to maintain electrical conductivity even when the passage and / or flexible sleeve is locally overstretched.

[0038] According to one embodiment, the electrical insulation portion of the flexible sleeve is made of silicone rubber.

[0039] According to one embodiment, the flexible sleeve comprises two electrically conductive passages including at least one conductive passage, and the two electrically conductive passages are isolated and separated from each other over the entire length of the flexible sleeve. In such a case, preferably, the distal end of the surgical instrument comprises two electrodes, each electrode electrically communicating with a single electrically conductive passage, thereby forming a bipolar electrosurgical instrument. Brief explanation of the drawing

[0040] Further features and advantages of the present invention will become apparent from the following description of preferred embodiments, given as a non-limiting reference, with reference to the accompanying drawings briefly described below. Note that references to "one" embodiment in this disclosure do not necessarily refer to the same embodiment and should be understood as referring to at least one. Furthermore, for reasons of brevity and reduction of the total number of drawings, a particular drawing may be used to illustrate features of more than one embodiment, and not all elements within the drawing may be necessary for a particular embodiment. FIG. 1a is an isometric projection of a robotic system for remote operation of surgery or microsurgery according to one embodiment; FIG. 1b is an unequal projection of a surgical instrument according to one embodiment. FIG. 2a is an illustration of a robotic system for remote operation of surgery or microsurgery according to one embodiment. FIG. 2b is an illustration of a robotic system for remote operation of surgery or microsurgery according to one embodiment. FIGS. 3a and 3b are vertical elevation views pictorially depicting a surgical instrument according to some embodiments. FIG. 3c is a vertical elevation view of a surgical instrument showing a longitudinal cross-section of a flexible sleeve mounted on the surgical instrument. FIGS. 4a and 4b are vertical elevation views pictorially depicting a surgical instrument according to some embodiments. FIGS. 5a and 5b are unequal projections showing a surgical instrument according to some embodiments. FIGS. 5C and 5D are longitudinal cross-sectional views of a portion of a flexible sleeve according to some embodiments. FIG. 5e is a cross-sectional view of a flexible sleeve according to one embodiment. FIG. 6a shows an unequal projection of a surgical instrument according to one embodiment. FIGS. 6b, FIGS. 6c and FIGS. 6d are longitudinal cross-sectional views of a portion of a flexible sleeve according to some embodiments. FIG. 6e shows an unequal projection of a surgical instrument according to one embodiment. FIGS. 6f, FIG. 6g, FIG. 6h, FIG. 6i, FIG. 6j, and FIG. 6k are unequal projections pictorially showing a flexible sleeve according to some embodiments. FIG. 7a shows an unequal projection of a surgical instrument according to one embodiment. Fig. 7b is a longitudinal cross-sectional view showing a portion of the flexible sleeve of the surgical instrument in Fig. 7a. FIG. 8 is a vertical elevation view of a surgical instrument showing a longitudinal cross-section of a flexible sleeve mounted on the surgical instrument. FIG. 9 is a longitudinal cross-sectional view of a portion of a flexible sleeve according to one embodiment. FIGS. 10a, FIGS. 10b, FIGS. 10c, FIGS. 10d, FIGS. 10e, FIGS. 10f, and FIGS. 10g are longitudinal cross-sectional views of a portion of a flexible sleeve according to some embodiments. FIGS. 11a and FIGS. 11b are unequal projections showing a surgical instrument according to some embodiments. FIG. 12 shows a surgical instrument in an isometric projection according to one embodiment. FIG. 13 shows a surgical instrument in an isometric projection according to one embodiment. FIGS. 14a, FIGS. 14b and FIGS. 15 show a flexible sleeve in partial longitudinal cross-section according to some embodiments. FIG. 16 is a cross-sectional view of an injection molding mold according to one embodiment. FIG. 17a is an unequal projection of a part of a mold for dip molding according to one embodiment. FIG. 17b shows a vertical elevation view of a part of the mold in FIG. 17a. Specific details for implementing the invention

[0041] Throughout the description of this specification, reference to "one embodiment" means that a specific feature, structure, or function described in relation to said embodiment is included in at least one embodiment of the present invention. Therefore, the expression “in one embodiment” in various parts of this description does not necessarily refer to the same embodiment. Furthermore, specific features, structures, or functions, such as those illustrated in different drawings, may be combined in any suitable manner in one or more embodiments.

[0042] According to a general embodiment, a surgical instrument (1) for robotic surgery comprises a proximal portion (2), a distal portion (3) movable relative to the proximal portion (2), and at least one motion joint portion (4) between the proximal portion (2) and the distal portion (3).

[0043] Preferably, the surgical instrument (1) belongs to a robotic system (5) for remote operation of surgery or microsurgery. According to one embodiment, for example Fig. 1a As illustrated in [Image], the robotic system (5) for remote surgical operation includes two surgical instruments (1) that are detachably mounted on two respective robotic manipulators (6) that can be operated under the control of a master console (not shown).

[0044] for example Fig. 1b As illustrated in the figure, the surgical instrument (1) may include a placement rod or shaft (26) having an articulated wrist portion at its distal end, and the placement rod or shaft (26) extends from a transmission interface portion (30) or a back end portion (30).

[0045] According to one embodiment, for example Fig. 2a and Fig. 2bAs illustrated in the figure, the surgical instrument (1) is an electrosurgical instrument (1), and the robotic system (5) for remote surgical operation further includes a pedal control (7) for activating the supply of radio frequency electrical energy for the electrosurgical instrument (1) and a generator (8) for generating a radio frequency current operably connected between the pedal control (7) and the electrosurgical instrument (1).

[0046] The surgical instrument (1) further comprises a flexible sleeve (10) mounted on at least one motion joint (4), and the sleeve (10) comprises a flexible body suitable for deforming (e.g., configured to deform) to conform to various operating configurations of at least one motion joint (4) of the surgical instrument (1).

[0047] Advantageously, the flexible sleeve (10) includes at least one electrical insulating part (11) and at least one electrically conductive passage (20).

[0048] The flexible sleeve (10) preferably comprises a proximal opening (14) and a distal opening (15) forming a longitudinally oriented internal through-channel (13) for receiving at least a rotary joint (4) of a surgical instrument. The proximal opening (14) of the flexible sleeve (10) may be defined by a proximal opening edge (16) facing proximally in the longitudinal direction. For example, the proximal edge (16) is formed by the thickness of the body of the flexible sleeve (10). The distal opening (15) of the flexible sleeve (10) may be defined by a distal opening edge (17) facing radially inward, that is, in the inner radial direction (RI). For example, the distal edge (17) is also formed by the thickness of the body of the flexible sleeve (10).

[0049] According to another embodiment, the flexible sleeve (10) forms a cap (10) having a closed distal end (18) that lacks through holes. In such a case, the closed distal end (18) of the flexible sleeve (cap) (10) may include a distal contact portion (23) exposed outside the cavity (13) in the distal direction.

[0050] Preferably, the flexible sleeve (10) can also be extended radially outward (RO), and as a result, when it is mounted on the surgical instrument (1), it is deformed and remains in a state of close contact with the surgical instrument due to its elasticity, that is, it is in close contact.

[0051] The distal portion (3) of the surgical instrument (1) may include the free end of the surgical instrument (1), such as the tip (24, 25) of the surgical instrument (1).

[0052] for example Fig. 3a As illustrated in the figure, the distal portion (3) may include two jaws (24, 25) or tips (24, 25) that are movable to be opened / closed (OP / CL) and both may be constrained within a motion joint portion (4) which is a rotary joint, and the proximal portion (2) may be a distal section of a rigid placement rod or shaft; a flexible sleeve (10) is mounted on the rotary joint while exposing the tips (24, 25) or jaws (24, 25) to the outside of the flexible sleeve (10) itself; at least one conductive passage (20) may be embedded within a portion of the electrically insulating body (11) to allow the tips (24, 25) or jaws (24, 25) to be electrically connected to the distal portion (27) of the rod (26) or shaft. In this case, the surgical instrument (1) may be a type of electrosurgical instrument (1) suitable for supplying cauterizing electric energy by its distal portion (3) which includes, for example, at least one tip or jaw (24, 25).

[0053] for example Fig. 3bAs illustrated in the figure, the distal portion (3) may include two jaws (24, 25) or tips (24, 25) that are movable to be opened / closed (OP / CL), and at least one motion joint portion (4) may include a rotary joint for the jaws or tips and also a flexible section (28) of the placement rod or shaft (26) as a distal section (27), such as a section including a plurality of stacked vertebrae ("snake", "flexible robotics"); a flexible sleeve (10) is mounted on the flexible section of the placement rod or shaft (26) acting as the motion joint portion (4); at least one conductive passage (20) of the flexible sleeve (10) extends along the flexible section (28) of the placement rod or shaft (26) while keeping the jaws (24, 25) or tips (24, 25) electrically conductively connected to the rigid section (29) of the placement rod or shaft.

[0054] for example Fig. 3c As illustrated in the figure, the distal portion (3) may include a single tip (24), i.e., a single link (24), and the motion joint portion (4) may include an articulated wrist portion (e.g., "pitch-yaw") comprising two rotational joints having mutually orthogonal axes; a flexible sleeve (10) is mounted on the articulated wrist portion and at least one conductive passage (20) places the distal portion (27) of a placement rod or shaft (26), which is rigid in this case, in electrically communicating with the single distal tip (24). In this case, the surgical instrument is preferably a unipolar type electrosurgical instrument (1). According to another embodiment, the surgical instrument (1) includes a sensor and / or camera and / or light emitter (e.g., LED) on its distal portion (3) that is electrically communicating with the proximal portion (2) by providing at least one conductive passage (20) of its flexible sleeve (10).

[0055] At least one conductive passage (20) preferably extends generally in the longitudinal direction with respect to the surgical instrument (1), that is, proximal to distal. In other words, the flexible electrical conductor (21) of the at least one conductive passage (20) extends generally in the longitudinal direction from the proximal contact portion (22) to the distal contact portion (23), where the longitudinal direction should be understood as the longitudinal direction of development of the surgical instrument in the section where the at least one motion joint portion (4) is present.

[0056] At least one motion joint part (4) may include a rotary joint and / or a flexible part ("snake", vertebra) as described above, and preferably, the at least one rotary joint is actuated by providing at least one actuating tendon (19). The at least one actuating tendon (19) may be made of a polymer material or a metal material.

[0057] If the at least one operating tendon (19) is made of a polymer material, such as a strand of braided polymer fibers, and the surgical instrument (1) is an electrosurgical instrument for supplying cauterizing electrical energy from its distal end, the flexible sleeve (10) may be fluidly sealed on the at least one motion joint (4) operated by the operating tendons (19) in order to avoid or at least minimize the possibility that smoke and vapor generated during electrosurgical operation will penetrate into the interior of the flexible sleeve (10) itself and cause potential damage to the polymer tendons (19).

[0058] The at least one motion joint (4) can be made of an electrically conductive material such as metal itself, and thus the distal end (27) of the already placed rod or shaft (26) and its at least one distal end tip (24) can be electrically connected; however, the provision of moving parts such as pin joints and / or stacked vertebrae that inevitably provide mechanical clearance, even if minimal, reduces conductivity in such moving parts, and thus providing the at least one conductive passage (20) within the flexible sleeve (10) allows for satisfactory, repeatable, and reliable conductivity.

[0059] for example Fig. 4a As illustrated in the figure, the at least one motion joint (4) may be a flexible section (28) of a placement rod or shaft (26) inserted longitudinally between two sections (29) of the same rigid placement rod or shaft; the provision of a flexible sleeve (10) having the at least one conductive passage (20) allows the two rigid sections of the rod or shaft to be arranged in electrically conductive communication. For example Fig. 4b As illustrated in the figure, the at least one motion joint (4) may be an articulated section of a placement rod or shaft (26) inserted longitudinally between two sections of the same placement rod or shaft that are rigid, and the articulated section includes, for example, two rotational joints having parallel axes.

[0060] The above at least one motion joint (4) can provide a degree of freedom of rolling or twisting around a definable longitudinal direction between the proximal part (2) and the distal part (3) of the surgical instrument.

[0061] The insulating portion (11) of the flexible body of the sleeve (10) may be made of silicone (silicone rubber) or other suitable material and is preferably provided above, i.e., outside, the at least one electrically conductive passage (20) of the same sleeve (10). As mentioned above, the at least one electrically conductive passage (20) crosses at least one motion joint portion (4) and is designed to arrange the proximal section (2) of the mechanism in electrically conductive communication with the distal section (3) of the same mechanism, thereby preferably insulating, i.e., covering by the insulating material (11).

[0062] The at least one electrically conductive passage (20) of the flexible sleeve (10) comprises a proximal contact portion (22) located proximal to the at least one motion joint portion (4) of the surgical instrument (1), a distal contact portion (23) located distal to the at least one motion joint portion (4) of the surgical instrument (1), and a flexible electrical conductor (21) extending from the proximal contact portion (22) to the distal contact portion (23). Thus, it is possible to create a conductive passage within the body of the flexible insulating sleeve across the motion joint portion (4) of the surgical instrument, while ensuring certain electrical conduction even where the motion joint portion requires the presence of a mechanical gap that locally reduces its own electrical conduction. In other words, a preferential path for current integrated within the flexible body of the insulating sleeve is created, while providing certainty of electrical conduction.

[0063] In addition, the flexible electric conductor (21) is located between the electrical insulation portion (11) of the flexible sleeve (10) and at least one motion joint portion (4) of the surgical instrument (1). That is, the flexible electric conductor (21) of the electrically conductive passage (20) of the flexible sleeve (10) is inserted between the electrical insulation portion (11) of the sleeve (10) itself and the surgical instrument (1), and in particular between at least one motion joint portion (4) of the surgical instrument (1), in a transverse direction or radial direction (RR) with respect to the longitudinal direction of the surgical instrument.

[0064] As an additional advantage, the distal contact portion (23) of the passage (20) of the flexible sleeve (10) is electrically connected to the distal portion (3) of the surgical instrument (1).

[0065] According to a preferred embodiment, the distal portion (3) of the surgical instrument (1)—which may include one or more tips or jaws (24, 25) movable to be opened / closed (OP / CL) as described above and / or a single electrode and / or sensor and / or camera and / or light for supplying cauterizing electrical energy—is at least partially made of an electrically conductive material such as metal. The section of the surgical instrument (1) protected by the flexible sleeve (10) and including the at least one rotary joint (4) is not necessarily made of an electrically conductive material. For example, in the absence of the conductive passage (20) of the flexible sleeve (10), an electrically insulating element such as a link and / or vertebra of the instrument may be provided to insulate the distal portion (3) of the instrument from the proximal portion (2).

[0066] According to another embodiment, for example Fig. 8As illustrated, the distal contact portion (23) of the conductive passage (20) of the flexible sleeve (10) itself forms the distal portion (3) of the surgical instrument (1) and, preferably, forms an electrode for supplying cauterizing electrical energy. The supply electrode formed by the distal contact portion (23) may be in the form of a metal ring and / or a metal cap or dome exposed outside the body of the flexible sleeve (10). In particular, Fig. 8 It also shows at least one motion joint (4) in a flexible sleeve (10) that is not electrically connected to the distal contact (23) but is electrically insulated from it, and said at least one motion joint (4) repositions and / or reorients the distal part (3) of the mechanism.

[0067] The placement rod or shaft of the surgical instrument (1) may include an electrically conductive body, and the proximal contact portion (22) of the conductive passage (20) of the flexible sleeve (10) preferably contacts the electrically conductive portion of the placement rod or shaft (26) in the proximal section (2) of the surgical instrument (1).

[0068] At least one flexible electric conductor (21) of at least one electrically conductive passage (20) of the flexible sleeve (10) can be manufactured in various ways.

[0069] for example Figs. 5a and 5bAs illustrated in the figure, the flexible sleeve (10) may include an electrically conductive passage (20) formed in the form of conductive microparticles embedded within a polymer matrix. Preferably, the polymer matrix in which the conductive microparticles are embedded is made of the same material as the electrical insulating portion (11) of the same flexible sleeve (10), such as silicone rubber (polydimethylsiloxane, or PDMS). The conductive microparticles may include carbon nanotubes dispersed within the silicone matrix. Therefore, the flexible electrical conductor (21) of the conductive passage (20) of the flexible sleeve (10) may be formed by the conductive microparticles dispersed within the polymer matrix.

[0070] for example Fig. 5c As illustrated in the figure, the conductive passage (20) can be positioned inwardly relative to the outer insulating material (11) and can face the surgical instrument (1), forming a proximal contact (22) in its proximal section, a distal contact (23) in its distal section, and a flexible conductor (21) in its intermediate section.

[0071] for example Fig. 5d As illustrated, the conductive passage (20) and, in particular, its flexible conductive section (21) can be inserted radially (RR) or transversely (RR) between two layers (11 and 12) of insulating material, while the proximal (22) and distal (23) contacts can be fabricated by exposing the conductive passage (20), for example, by removing a portion of the inner insulating layer (12).

[0072] for example Fig. 5eAs illustrated in the figure, the flexible sleeve (10) may comprise an outer insulating layer (11) and two conductive passages (20) in the form of conductive microparticles dispersed within a polymer matrix, which are positioned radially inward (RI) relative to the outer radial insulating layer (11). Preferably, the outer insulating layer (11) of the flexible sleeve (10) is also radially elongable (RR) so that it can extend radially inward (RI) around the conductive passages (20) when mounted on at least one motion joint (4) of the surgical instrument (1). Thus, the flexible sleeve (10) can be manufactured by attaching the insulating material (11) and the conductive microparticles in two consecutive castings, while avoiding casting the insulating material circumferentially between the two conductive passages in the form of conductive microparticles. In other words, the inner layer of the flexible sleeve (10) in the circumferential direction (CC) may include empty spaces between conductive passages (20) that are filled during use due to the inner radial deformation (RI) of the body of the outer insulating layer (11) of the flexible sleeve (10). To form the conductive passages (20) in the form of fine particles, a shaped core defining the conductive passages in the circumferential direction (CC) may be used.

[0073] for example Fig. 6aAs illustrated in the figure, the flexible electrical conductor (21) of at least one conductive passage (20) of the flexible sleeve (10) may be made of an electrically conductive metal wire, strand, or strip, such as 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 electrical conductor (21) is previously placed. Proximal and distal contacts (22, 23) may be formed by metal rings in contact with the flexible conductor (21). In such a case, the rings may also be placed in the mold or shape before casting the insulating material (11) (e.g., silicone rubber or polydimethylsiloxane PDMS). The proximal contact (22) and / or distal contact (23) may each be exposed by the insulating body of the flexible sleeve (10) radially inward and / or radially outward and / or longitudinally in the proximal or distal direction. Silicone rubber can be produced by the polyaddition of two components.

[0074] for example Fig. 6b As illustrated in the figure, the radially inner portion of the flexible sleeve (10) may include an electrically conductive passage (20) formed by the flexible electric conductor (21), and the flexible electric conductor (21) consequently forms a proximal contact (22) in its proximal section and a distal contact (23) in its distal section.

[0075] for example Fig. 6c As illustrated in the figure, a flexible electric conductor (21) can be inserted radially between two layers (11, 12) of insulating material, wherein proximal and distal contacts (22, 23) can be made in the form of conductive rings.

[0076] The proximal and / or distal contact portions (22, 23) are not necessarily exposed radially outside the body of the flexible sleeve (10), and, for example Fig. 6-D According to one embodiment as illustrated, the distal contact portion (23) may be formed by a conductive ring that is exposed radially inward and distally in the longitudinal direction.

[0077] for example Fig. 6e As illustrated in the figure, the flexible conductor (21) of the conductive passage (20) may be made of a wire, tape, or strip having a spherical passage comprising a plurality of folds. The provision of the spherical passage allows satisfactory conductivity between the proximal contact and the distal contact (23) to be maintained even if at least a portion of the flexible body of the sleeve (10) is overextended.

[0078] for example Fig. 6f As illustrated in [Image], the flexible conductor (21) can be substantially spirally or helically extended around a definable longitudinal axis of the flexible sleeve (10).

[0079] for example 6g and Fig. 6h As illustrated in [Image], the flexible conductor (21) may be formed by a conductive plate or strip in which cuts are made inside to impart flexibility. The cut plate or strip may comprise one or more sheets of carbon nanotubes. Alternatively or additionally, the conductive plate or strip may be made of a metal plate or metal foil, such as copper, gold, or similar.

[0080] for example Fig. 6i As illustrated in [Image], an armature of a conductive material may be provided, comprising two rings for forming proximal and distal contact portions (22, 23) and a plurality of flexible conductors extending between them.

[0081] The conductive passage (20) is not necessarily exposed longitudinally (distal and / or proximal) outside the body of the flexible sleeve (10).

[0082] for example Fig. 6j As illustrated in [Image], the conductive passage (20) may include one or more data transmission passages.

[0083] for example Figure 6k As illustrated in the figure, the conductive passage (20) may include a mesh body formed by conductive elements braided together in the same manner as a stent. Proximal (22) and distal (23) contacts may be formed, for example, by exposing the mesh body radially inward.

[0084] As mentioned above, the distal opening (15) of the flexible sleeve may be contoured by the distal contact portion (23) of the passage (20), or the distal opening (15) may be positioned further distal to the distal contact portion (23), in which case the distal contact portion may be exposed radially inward by contacting the distal portion (3) of the surgical instrument.

[0085] The proximal opening (14) of the flexible sleeve (10) may be contoured by the proximal contact portion (22) of the passage (20), or the proximal opening (14) may be positioned further proximal to the proximal contact portion (22), in which case the proximal contact portion may be exposed radially inward and / or radially outward of the flexible sleeve body.

[0086] According to one embodiment, the proximal contact portion (22) is exposed radially outward, for example, by a hole in the outer insulating layer (11) of the sleeve itself, to form a kind of port or plug, and is designed to accommodate an electrical conductor such as an electric wire.

[0087] for example Fig. 7aAs illustrated in [Figure], the conductive passage (20) may include a flexible conductor (21) made of conductive microparticles and proximal and distal contacts (22, 23) made of rings of rigid metal material. In such a case, for example Fig. 7b As illustrated in [Image], a flexible conductor (21) containing conductive microparticles can be radially inserted and extended between two layers (11, 12) of electrical insulating material.

[0088] Preferably, the at least one conductive passage (20) is formed integrally with the insulating portion (11, 12) of the flexible sleeve (10). In other words, when in use, there is no relative local displacement between the at least one conductive passage (20) and the insulating portion of the flexible sleeve.

[0089] According to another embodiment, for example Fig. 9 As illustrated in the figure, a longitudinal gap is provided between the at least one conductive passage (20) and the insulating material (11, 12) of the flexible sleeve (10), that is, in other words, the at least one conductive passage (20), and in particular at least the flexible conductor (21), can slide locally longitudinally with respect to the insulating portion (11, 12) of the flexible sleeve (10). In such a case, an elastic element (KE) capable of achieving a preload intended to keep the flexible conductor (21) taut may be provided. To achieve the preload, the distal contact portion (23) may act as an end-of-stroke.

[0090] for example Fig. 10aAs illustrated in the figure, according to one embodiment, the proximal contact portion (22) is exposed longitudinally to the outside of the proximal opening edge (16), that is, exposed longitudinally by the thickness of the body of the flexible sleeve (10). In such a case, the distal contact portion (23) may be exposed radially inward before the distal opening (15). According to another embodiment, for example Fig. 10b As illustrated in the figure, the distal contact portion (23) is exposed to the outside of the distal opening edge (17), that is, it is exposed radially inward through the thickness of the sleeve at the distal opening.

[0091] for example Fig. 10c As illustrated in [Figure], according to one embodiment, the proximal and distal contacts are both exposed radially inward but are longitudinally offset with respect to the proximal and distal openings. According to another embodiment, for example, Fig. 10d As shown in the illustration, the distal contact portion is exposed radially inward at the edge of the distal opening (17).

[0092] for example Fig. 10e As illustrated in [Image], a conductive passage (20) containing conductive microparticles may be provided, which is entirely exposed in the inner radial direction (RI) and itself forms both the proximal contact portion (22) and the distal contact portion (23).

[0093] The surgical instrument (1) is preferably an electrosurgical instrument, wherein its distal portion (3) includes at least one electrode for supplying electrical energy.

[0094] Electrosurgical devices can be of the unipolar or bipolar type.

[0095] If the electrosurgical device is of the positive type, two separate conductive passages are preferably provided within the flexible body of the sleeve (10), wherein one conductive passage acts as a forward path to the distal portion (3) and the other separate conductive passage acts as a return path from the distal portion to the proximal contact portion (22). Alternatively, where the electrosurgical device is of the positive type, a single conductive passage may be provided within the flexible sleeve (10), which acts as, for example, a forward path to the distal portion (3), and the other return conductive passage may be formed by another conductor.

[0096] According to one embodiment, for example Fig. 11a and Fig. 11b As illustrated in the figure, the electrosurgical device (1) is of the anode type, and in the anode type, the distal portion (3) includes two tips (24 and 25) acting as a forward electrode and a return electrode, respectively, and in the anode type, the flexible body of the sleeve (10) includes two distinct conductive passages (20 and 20'). In this case, the flexible sleeve (10) includes two proximal contact portions (22 and 22') and two distal contact portions (23 and 23').

[0097] According to one embodiment, for example Fig. 12 As illustrated in [Image], the electrosurgical device (1) is of the positive type, and the proximal (22, 22') and distal (23, 23') contacts are made of rigid conductive elements, such as metal rings, while the conductors (21 and 21') between them are made of conductive microparticles.

[0098] According to one embodiment, for example Fig. 13 As illustrated in [Image], the electrosurgical device (1) is of the positive type, and the proximal contacts (22 and 22') are formed by conductive plugs.

[0099] A method for manufacturing a flexible sleeve (10) will be described below.

[0100] According to a general manufacturing method, a method for manufacturing a flexible sleeve (10) for a surgical instrument (1) is as follows:

[0101] - A step of providing an injection molding mold (40) comprising a male element (42), i.e., a tubular core (42) and a female element (43);

[0102] - Step of placing an electrically conductive material on a number element (42);

[0103] - A step of assembling a female element (43) to the male element (42) of the mold (40) to create a mold cavity (41) between the male element and the female element - an electrically conductive material is present in the mold cavity (41) -;

[0104] - Step of casting and / or injecting a flexible material, such as silicone rubber or PDMS, into a mold cavity (41)

[0105] Includes

[0106] To manufacture a multilayer sleeve, a single arm element and multiple number elements of different sizes progressively linked may be included, or a single number element and multiple arm elements of different sizes progressively linked may be included.

[0107] A method for manufacturing a flexible sleeve (10) will be described below.

[0108] According to a general manufacturing method, a method for manufacturing a flexible sleeve (10) for a surgical instrument (1) is as follows:

[0109] - Step of providing a tubular core (42) for immersion molding;

[0110] - Step of immersing a tubular core (42) in a polymer matrix that may or may not contain dispersed conductive microparticles

[0111] Includes

[0112] The method may further include the steps of preheating a tubular core to produce a distal opening of a flexible sleeve (10) and / or cutting off the distal end of a polymer matrix that has solidified once separated from the tubular core. A polymer matrix, with or without conductive microparticles, may be contained in a tank (not shown), and within the tank, a tank lid (44) may contain a plurality of tubular cores (42) that cantilevered from it to be immersed in the tank to produce a plurality of flexible sleeves at once while aiding in the mass production of flexible sleeves.

[0113] Thanks to the features described above, provided together or separately in specific embodiments, it is possible to satisfy the aforementioned needs while obtaining the aforementioned advantages, and in particular:

[0114] - It allows one or more conductive passages to be integrated within the flexible body of a sleeve mounted on the motion joint of a surgical instrument;

[0115] - Proper insulation of one or more conductive passages is also achieved by including at least one layer of dielectric material (electrically insulating) outside of one or more passages;

[0116] Therefore, it is possible to ensure satisfactory electrical conductivity even in motion joints, which typically cause uncertainty in conductivity when in various operational configurations including moving parts and gaps, even if minimal;

[0117] - The surgical instrument (1) is preferably an electrosurgical instrument (1), and a flexible sleeve (10) having at least one conductive passage (20) acts as an electric conductor to carry current to one or more electrodes of the electrosurgical instrument.

[0118] It is well understood that the combinations of features disclosed in the appended claims form an essential part of the present disclosure.

[0119] To satisfy specific incidental needs, those skilled in the art may make various changes and modifications to the embodiments described above and replace elements with other functionally equivalent ones without departing from the scope of the appended claims. Explanation of the symbols

[0120] 1 Surgical or microsurgical instrument 2 Proximal part of the surgical instrument 3. Distal end of the surgical instrument 4. Motion joint of surgical instrument 5. Robotic system for remote operation of surgery or microsurgery 6 robot manipulators 7 Pedal Control 8 generators 10 Flexible sleeves for surgical instruments 11 Electrical insulation part or insulating layer of the sleeve 12 Inner layer of electrical insulation 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 operating tendons Conductive channels of the 20, 20' flexible sleeve Flexible electric conductor of 21, 21' path Proximal contact of the 22, 22' passage 23, 23' Distal contact of the passage 24 tips or jo 25 tips or jo 26 batch rods or shafts 27 Distal end of a rod or shaft 28 Flexible part of a rod or shaft 29. The rigid part of a rod or shaft 30 Transmission interface section or backend 40 injection molding molds 41 mold cavity 42 number elements or tubular cores 43 Arm Element 44 Lid for immersion molding mold DISTAL Distal Direction RO outer radius direction RI medial radius direction KE elastic element Degrees of freedom of orientation of the distal part of the Y mechanism Degrees of freedom for opening and closing OP / CL

Claims

Claim 1 A surgical instrument for robotic surgery or microsurgery comprises: a proximal portion and a distal portion movable with respect to the proximal portion; at least one motion joint between the proximal portion and the distal portion; and a flexible sleeve mounted on the at least one motion joint, wherein the flexible sleeve comprises a flexible body configured to deform to conform to various operating configurations of the at least one motion joint; and wherein the flexible sleeve comprises at least one electrical insulating portion and at least one electrically conductive passage, and wherein the at least one electrically conductive passage comprises: a proximal contact portion located proximal to the motion joint of the surgical instrument; and a distal contact portion located distal to the motion joint of the surgical instrument. A surgical instrument comprising a flexible electric conductor extending from the proximal contact portion to the distal contact portion, wherein the flexible electric conductor is located between the electrical insulation portion of the flexible sleeve and the at least one motion joint portion of the surgical instrument, and wherein the distal contact portion communicates of electric conduction with the distal portion of the surgical instrument. Claim 2 A surgical instrument according to claim 1, wherein the distal contact portion of the flexible sleeve itself forms the distal portion of the surgical instrument. Claim 3 A surgical instrument according to claim 1, wherein the proximal contact portion contacts the proximal portion of the surgical instrument, and the proximal portion of the surgical instrument comprises a rigid placement shaft or stick or beam. Claim 4 A surgical instrument according to claim 1, wherein at least one motion joint part comprises a rotary joint or a pin joint, and the rotary joint comprises an articulating wrist part having two pin joints having mutually orthogonal axes. Claim 5 A surgical instrument according to claim 1, wherein the at least one electrically conductive passage comprises: a conductive microparticle comprising a carbon micro- or nano-structure dispersed in a polymer matrix; an electrical conductor comprising a metal wire or a stranded metal wire; a flexible printed circuit; and a conductive plate made of carbon fiber comprising cuts to impart flexibility. Claim 6 A surgical instrument according to claim 1, wherein the flexible electrical conductor of the at least one electrically conductive passage forms a tortuous passage or an inclined passage with respect to the longitudinal development direction of the flexible sleeve in order to maintain electrical conductivity even when the passage or flexible sleeve is locally hyperextended. Claim 7 A surgical instrument according to claim 1, wherein at least one of the proximal contact portion and the distal contact portion is made of a metal ring or part thereof and is arranged around each of at least one of the proximal portion and the distal portion of the surgical instrument. Claim 8 A surgical instrument according to claim 1, wherein the electrical insulation portion of the flexible sleeve is made of silicone rubber. Claim 9 The surgical instrument according to claim 1, wherein the distal contact portion is electrically connected to the operating portion of the surgical instrument, and the operating portion comprises: an electrode for supplying electrosurgical cautery energy; a sensor for detecting at least one of the position and orientation of at least one of at least one of the motion joint portion and the distal portion of the surgical instrument; a sensor for detecting the temperature of at least one of the surgical instrument and the workspace; a visual system; a visible light emitter; and at least one of a radio frequency emitter and an ultrasonic energy emitter. Claim 10 In claim 1, the flexible sleeve includes a distal opening, and the distal portion of the surgical instrument is exposed from the distal opening of the flexible sleeve, the surgical instrument. Claim 11 A surgical instrument according to claim 1, wherein the distal contact portion is housed within a seat formed inside the body of the distal portion of the surgical instrument, and the seat comprises at least one of a notch, a groove, and a rib. Claim 12 A surgical instrument according to claim 1, wherein the flexible sleeve comprises two electrically conductive passages including at least one electrically conductive passage, and the two electrically conductive passages are disjointed and separated from each other over the entire extension of the flexible sleeve, and the distal portion of the surgical instrument comprises two electrodes, each electrode electrically communicating with a single electrically conductive passage to realize a bipolar electrosurgical instrument. Claim 13 A surgical instrument according to claim 1, wherein the size of the flexible sleeve is smaller than the size of the surgical instrument or smaller than the size of the at least one motion joint, so that when the flexible sleeve is extended radially and circumferentially to fit the surgical instrument or the at least one motion joint, it adheres to the body of the surgical instrument. Claim 14 A surgical instrument according to claim 1, wherein the proximal contact portion or the distal contact portion comprises at least one of a conductive pad, a conductive site, a magnet, a conductive deposit, and conductive microparticles. Claim 15 A surgical instrument according to any one of claims 1 to 14, wherein the flexible electric conductor of the at least one electrically conductive passage extends longitudinally from the proximal contact portion to the distal contact portion.

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