Sterile master input handle assembly for robotic surgical system and surgical drape for the sterile master input handle

Abstract

The sterile master input handle assembly (302) includes a non-sterile manipulandum (310), a sterile surgical drape (303) that drapes the non-sterile manipulandum (310), and at least one sterile accessory (306) suitable for forming a sterile interface of the sterile master input handle assembly (302) with a surgeon's fingers. The at least one sterile accessory (306) mechanically engages the non-sterile manipulandum (310) across the sterile surgical drape (303). The at least one sterile accessory (306) covers at least a portion of the outer surface (305) of the surgical drape (303). The at least one sterile accessory (306) includes at least one surface (307) that forms a sterile interface for the surgeon's fingers to manipulate the non-sterile manipulandum (310) across the sterile surgical drape (306).

Description

[Technical Field]

[0001] The object of the present invention is a sterile master input handle assembly. The sterile master input handle assembly is suitable for robotic surgery. The present invention also relates to a master controller assembly including at least one sterile master input handle assembly and a master console. The present invention also relates to a robotic surgery system including at least one sterile master input handle assembly. Furthermore, the present disclosure relates to a surgical drape for the sterile master input handle. [Background technology]

[0002] A robotic surgical device used in robot-assisted surgery generally includes a surgeon master console for receiving manual commands from a surgeon, a robot slave central tower (or robot cart), and multiple robot slave arms extending from the slave central tower and carrying one or more surgical instruments (end effectors) controlled by means of the surgeon master console. The one or more slave surgical instruments are attached distally to the robot slave arms to perform a surgical procedure on a patient lying in a sterile operating room field. To avoid contamination of the sterile surgical field caused by the robotic surgical instruments, surgical drapes are typically provided to cover the portions of the robotic instruments that are not designed to be discarded after use. Straps and strings may be provided on the exterior of the surgical drape to reduce the volume of the drape around the robot so that it fits substantially tightly.

[0003] For example, commonly assigned WO-2017-064301 and WO-2018-189729 disclose robotic surgical system solutions that are particularly suited to robot-assisted microsurgery and, as a result, miniaturized surgical instruments. In conventional (non-robotic) microsurgery, surgeons must operate using a surgical microscope, typically an optical microscope, that can magnify the surgical field. Therefore, robotic surgical devices for microsurgery are preferably equipped with a surgical microscope. Surgical drapes for draping microscopes have been provided, as shown, for example, in US-2019-0069969 and JP-6367019.

[0004] Microsurgery is performed in several stages of the reconstruction of biological tissues, for example in the execution of vascular anastomoses consisting of small vessels and nerves, and in the reconstruction of anatomical parts after the occurrence of traumatic lesions, in tissue revascularization, reattachment, transplantation and replantation of limbs. In the field of microsurgery, robotic devices allow for a high degree of miniaturization of surgical instruments compared to conventional microsurgery, while at the same time reducing the transmission of vibrations to the slave surgical instruments of the robotic surgical system.

[0005] The robotic surgical device is also suitable for robotically assisted laparoscopic surgery, in which surgical instruments and at least one camera are individually inserted into the patient's body using a set of percutaneous trocars, and a visualization screen visualizes laparoscopic images of the patient's interior obtained from the cameras. The robotic-assisted device reduces the fulcrum effect during surgery caused by the lever arm formed along the length of each percutaneous rigid trocar when manipulating conventional (non-robotic) laparoscopic surgical instruments. Furthermore, thanks to the robotic assist, the laparoscopic surgeon is provided with improved comfort during surgery due to the ergonomic features of the surgeon master console.

[0006] Remote surgeon master consoles have been provided, for example, as shown in US-2014-0018960 and EP-2845556. Generally, such remote surgeon master consoles include a visualization device, a surgeon seat and / or surgeon forearm rest elements, and a master control handle. The master control handle takes the form of an attachment hinged to the body of the master console for receiving manual commands from the surgeon to control slave surgical instruments. This enhances the comfort of the laparoscopic surgeon and allows for non-surgical operation without the surgeon having to enter the sterile field of an operating room. sterile Surgery can be performed from remote locations.

[0007] However, having a large physical distance between the team in the sterile operating room field and the surgeon handling the master input accessories on the remote master console may create communication problems during surgery between the team, especially with the surgeon.

[0008] Therefore, even in the presence of robotic surgical systems, surgeons still feel the need to enter a sterile operating room.

[0009] Additionally, in some applications of robotic-assisted microsurgery, it is desirable for the surgeon to be present within the sterile operating room field during the robotic-assisted procedure, thereby allowing the microsurgeon to switch from robotic-assisted microsurgery to One can switch to conventional (non-robotic) microsurgery using hand-held conventional microsurgery tools such as forceps, and / or return to the Surgeon Master Console.

[0010] For example, US-2019-328473 shows a master console that can be covered during operation with a sterile drape attached to a master input accessory (a sterile, exposed, restrained, motor-driven master input accessory) that is rotatably mounted to the master console.

[0011] For example, US-10512515 discloses a non-surgical device with a hand trackball and integrated display that is covered by a sterile drape. sterile Master input handle. US-8368649 shows a similar solution, sterile The mouse pad is placed on an active sensing base for driving a computerized medical device.

[0012] For example, WO-2014-151621 discloses a system for alternating manual and robotic surgery using a mechanically ungrounded master controller designed to be held in the hand of a surgeon. Wearable, mechanically ungrounded master controllers are also known from, for example, WO-2019-099854 and EP-2467082, and typically have a pair of rings that fit over the surgeon's fingers that are integrally associated with the grip command interface of the ungrounded master controller.

[0013] Furthermore, WO-2019-220407, WO-2019-220408, and WO-2019-220409, both of which are owned by the same applicant, disclose several embodiments of a handheld master input handle that is mechanically ungrounded and unconstrained relative to the master console and, as a result, freely movable relative to the console within a predefined tracking volume for controlling a mated slave surgical instrument. The handheld master input handle has a master gripper. The master gripper includes internal degrees of freedom for controlling the paired gripping degrees of freedom of a mated slave surgical instrument, such as a needle holder slave surgical system. Mechanically unconstrained master input handles of the above type have recently emerged as an advantageous solution for controlling slave robotic surgical instruments in that they enable an extended range of motion for the surgeon and a scale factor can be provided so that large surgeon movements are translated into small movements of the slave robotic surgical instrument. A tracking device, such as an optical or magnetic device, may be integrally provided with the master console to track the position and / or orientation of the mechanically unconstrained master input handle within the workspace. To this end, the master input handle may be equipped with optical markers and / or magnetometers.

[0014] However, unrestrained master input handles must be properly inspected before and after use in a sterile environment. sterile Alternatively, an unconstrained master input handle may be designed for one-time use only, and may be costly, despite its high technical content and / or tight manufacturing tolerances, in order to be tracked in the workspace with the highest level of spatial accuracy.

[0015] It is felt that a balance must be struck between the conflicting needs of providing a master input handle for robotic surgery that allows a high range of motion in the surgeon's hand while at the same time providing precise control of a paired slave surgical instrument, without the need for it to be single use, or at least limiting to a minimum the technical content, and hence manufacturing costs and materials employed, of the portions of the master input handle that need to be disposable.

[0016] There is also a need for solutions that allow surgeons to effectively alternate between robotic-assisted surgery and traditional hand surgery.

[0017] At the same time, there is a felt need to simplify the switch from robotic to conventional surgery and vice versa in a single intervention. Summary of the Invention

[0018] It is the scope of the present invention to overcome the drawbacks mentioned with reference to the prior art and to provide a master input handle solution for use in the sterile field.

[0019] It is the scope of the present invention to overcome the drawbacks mentioned with reference to the known art and to provide a solution for draping a master input handle for use in the sterile field.

[0020] These and other scopes are achieved by a master input handle assembly according to claim 1, a master controller assembly according to claim 19, a robotic surgical system according to claim 21, and a surgical drape according to claim 22.

[0021] Some preferred embodiments are the subject of dependent claims.

[0022] In accordance with one aspect of the present invention, the sterile master input handle assembly is sterile Manipulandum and the non- sterileA sterile surgical drape is provided to cover the manipulandum, and at least one sterile accessory adapted to form a sterile interface of the sterile master input handle assembly against the surgeon's fingers.

[0023] According to one aspect of the present invention, the at least one sterile accessory is configured to extend across the sterile surgical drape to the non-sterile surgical drape. sterile and a manipulandum, the at least one sterile accessory mechanically engaging the manipulandum, the at least one sterile accessory covering at least a portion of an outer surface of the surgical drape, the at least one sterile accessory configured to prevent a surgeon's fingers from moving non-permanently across the sterile surgical drape. sterile To operate the manipulandum sterile The device is characterized by including at least one interface surface that forms an interface.

[0024] sterile The master input handle assembly may be designed to be handheld by a surgeon during surgery. sterile It may fully support the weight of the master input handle assembly.

[0025] The sterile master input handle assembly may be mechanically ungrounded and includes features designed to be tracked by an associated tracking system to determine the position and / or orientation of the master input handle assembly within a predefined working volume for controlling at least one paired slave surgical instrument. The working volume is preferably integral to the tracking system. The features designed to be tracked by the associable tracking system may include one or more optical markers and / or one or more magnetometers. The tracking system may be an optical tracking system consisting of a camera set and / or a magnetic tracking system consisting of a magnetic field generator. The sterile master input handle assembly is preferably freely movable relative to the tracking system. The sterile master input handle assembly is preferably designed to be freely rolled between a surgeon's fingers.

[0026] Two sterile master input handle assemblies may be provided, one for each surgeon's hand.

[0027] sterile The interface surface of the accessory is sterile To improve the surgeon's grip on the master input handle assembly, the friction surface may have a predetermined value of surface roughness greater than the surface roughness of the outer surface of the surgical drape.

[0028] sterile The interface surface of the accessory may be convex for facing one or more of the surgeon's fingers. Such a convex interface surface may include: sterile While the master input handle assembly is held in the surgeon's hand, the surgeon sterile The master input handle assembly may be allowed to roll easily.

[0029] The sterile master input handle assembly is configured to accommodate at least two sterile attachments to a single master input handle assembly, in other words, a single non-sterile attachment across the surgical drape. sterile and two sterile attachments that engage the manipulandum, whereby the fingers of the surgeon's hand move across the sterile surgical drape to engage the non-sterile manipulandum. sterile A further, second sterile accessory may be included to provide at least two opposing interface surfaces for grasping the manipulandum. sterile The master input handle assembly is designed to be held by one hand of the surgeon during surgery. sterile Two sterile accessories may be provided on opposite sides of the manipulandum, with the purpose of exposing two convex interface surfaces in opposite directions. sterile The two convex interface surfaces may be provided on opposite sides of the body of the manipulandum, one facing away from the other.

[0030] The sterile master input handle assembly may include at least one degree of freedom between the two opposing interface surfaces. The at least one degree of freedom may be a grip degree of freedom designed to control a mating slave degree of freedom of a grip of a slave surgical instrument. To actuate the grip degree of freedom, the two opposing interface surfaces may be moved toward each other by application of a pressing action, for example, by the surgeon's fingers. The degree of freedom between the two opposing interface surfaces may be a non-contact type consisting of two parts, one of which can move relative to the other, such as, for example, two articulated parts and / or push buttons and / or two parts slidably associated with each other. sterile Said degree of freedom between two opposing interface surfaces may be defined by at least one attachment itself, for example by a deformable bridge between the two interface surfaces.

[0031] Said degree of freedom between two opposing interface surfaces may be an elastically loaded degree of freedom, for example a deformable bridge between two accessories is an elastically deformable bridge, for example consisting of or made of leaf springs.

[0032] In at least one configuration, the elastic action of the elastically loaded degree of freedom urges the two opposing interfacing surfaces away from one another.

[0033] In at least one configuration, the two opposing interface surfaces together define a convex cylindrical geometric shape. For example, when the sterile master input handle assembly is in a closed configuration, the closed configuration is sterile This is achieved by moving two articulating portions and / or two opposing interface surfaces of the manipulandum toward each other, the two opposing interface surfaces together defining a convex cylindrical shape. Providing such a convex cylindrical shape is advantageous for rolling the sterile master input handle assembly between the fingers of the surgeon's hand. The two opposing sterile accessories may be made in a single piece, in other words, the two sterile accessories may be monoblock.

[0034] The above non sterile The manipulandum has at least one pair of elongated elements hinged to one another to form a tool joint, at least one of the elongated elements having at least one convex body. sterile An accessory engages with the convex body. Each of the elongate elements has the convex body. The sterile accessory may engage with the convex body of each of the elongate elements.

[0035] The at least one interface surface may include bosses and / or valleys for receiving the surgeon's fingers.

[0036] According to one aspect of the present invention, a master controller assembly includes at least one sterile master input handle assembly and at least one tracking system designed to track the position and / or orientation of at least a portion of the at least one sterile master input handle assembly. The tracking system may reside in a master console of the master controller assembly for tracking the position and / or orientation of the sterile master input handle assembly relative to the master console. The master console may have a pair of sterile master input handle assemblies.

[0037] According to one aspect of the present invention, a robotic surgical system includes at least one sterile master input handle assembly and at least one slave robot assembly including at least one surgical instrument, which may include a gripping degree of freedom controlled by the master input handle assembly.

[0038] According to one aspect of the present invention, a robotic surgical system includes a master controller assembly and at least one slave robot assembly including at least one surgical instrument, which may include a grip degree of freedom controlled by a master input handle assembly.

[0039] In accordance with one aspect of the present invention, a surgical drape for a master input handle assembly is provided. sterile The surgical drape may include a pair of pouches for respectively receiving the pair of elongate elements of the manipulandum. The surgical drape may include a bifurcation from which the pair of pouches extend distally. The pair of pouches may extend proximally from the bifurcation.

[0040] Thanks to the proposed solution, a non-surgical device can be designed to receive manual commands from a user (i.e., a surgeon) in a sterile operating field and can be reused for several operations. sterile A manipulandum is provided.

[0041] The proposed solution provides a master input handle assembly having a drape for draping a master manipulandum, the assembly having sterile accessories that can be coupled to the manipulandum to form an interface for the surgeon's fingers within a sterile operating field. Furthermore, the manipulandum covered by the sterile barrier assembly exposes an interface surface thereon for the purpose of providing a stable grip for the surgeon's fingers during robotic-assisted microsurgery.

[0042] Safety in operating a robotic surgical master controller is enhanced because a manipulandum covered by a surgical drape will slip between the surgeon's fingers, reducing the risk of exposing the outer surface of the drape to the surgeon's fingers in the absence of such a sterile accessory.

[0043] The proposed solution is particularly suitable, although not exclusively limited to, robotic-assisted microsurgery. Furthermore, the proposed solution is particularly suitable, although not exclusively limited to, microsurgical procedures intended to replace hand microsurgery and robotic-assisted microsurgery.

[0044] Further features and advantages of the assembly and system according to the invention will become apparent from the following description of preferred embodiments thereof, given by way of illustrative and non-limiting example, with reference to the accompanying drawings, in which: [Brief explanation of the drawings]

[0045] [Figure 1] FIG. 1 is a schematic axial view of a robotic surgical system suitable for microsurgery, according to an embodiment. [Figure 2] FIG. 2 is a schematic axial view of a sterile master input handle assembly within a sterile operating field, according to an embodiment. [Figure 3] FIG. 3 is an elevational view showing a sterile master input handle assembly, according to an embodiment. [Figure 4] FIG. 4 is an axial view of a portion of a sterile master input handle assembly including a draped non-sterile manipulandum and a sterile accessory schwann as separate parts, according to an embodiment. [Figure 5] FIG. 5 is a plan view of an accessory, according to an embodiment. [Figure 6] FIG. 6 is an axial view of a non-sterile manipulandum, according to an embodiment. [Figure 7] FIG. 7 illustrates a surgical drape, according to an embodiment. [Figure 8] FIG. 8 is an axial view showing the sterile master input handle assembly as a separate part, according to an embodiment. [Figure 9] FIG. 9 is an axonometric view showing one of the elongated elements of a non-sterile manipulandum within a respective sterile drape pouch, according to an embodiment. [Figure 10] FIG. 10 is an axonal view showing one of the elongated elements of a non-sterile manipulandum within a respective sterile drape pouch, according to an embodiment. [Figure 11] FIG. 11 illustrates a surgical drape integrated with two attachments, according to an embodiment. [Figure 12] FIG. 12 shows a portion of a master-slave robotic surgical system including two sterile master input handle assemblies and two slave surgical instruments while being held by a surgeon within a working volume, according to an embodiment. [Figure 13] FIG. 13 illustrates a sterile master input handle with an interface surface configured to engage a cylindrical convex shape, according to an embodiment. [Figure 14] FIG. 14 is an axial view of an attachment of a sterile master input handle assembly, according to an embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0046] According to a typical embodiment, a sterile master input handle assembly 302 for a robotic surgical system 300 is sterile Manipulandum 310 and the non- sterile and a sterile surgical drape 303 for draping the manipulandum 310.

[0047] According to a preferred embodiment, the non sterile The manipulandum 310 is a non-transitory robotic surgical system for the master-slave type robotic surgery system 300. sterile The master controller 310.

[0048] According to a preferred embodiment, the non sterile The Manipulandum 310 itself is sterile Like Operating Room 311 sterile It is not suitable for reuse within the environment.

[0049] According to a preferred embodiment, the non sterile The manipulandum 310 has a body adapted to be held in the hand by a surgeon.

[0050] Not necessarily sterile Although the manipulandum 310 is not necessarily mechanically ungrounded from the master console 350 of the robotic surgical system 300, according to a preferred embodiment, said ungrounded sterile Manipulandum 310 is mechanically ungrounded.

[0051] According to a preferred embodiment, non sterile The manipulandum 310 is not mechanically grounded or mechanically constrained from the robotic surgical system 300. sterile The manipulandum 310 is designed to cooperate with a tracking system 339 of the robotic surgical system 300, such as an optical and / or magnetic tracking system, to track non-surgical objects within a predetermined working volume 320. sterile The position and / or orientation of the manipulandum can be tracked by a tracking system 339 for control of a companion slave surgical instrument.

[0052] The sterile drape 303 may be a loose or tightly fitted sheet of surgical drape material, or may be partially loose and partially tightly fitted, and may be made of, for example, a polymeric material. For example, the body of the surgical drape 303 may be made of a flexible sheet of polyethylene, and / or polyurethane, and / or polyester.

[0053] According to an embodiment, sterile The drape 303 has an inner surface 304, i.e., a non- sterile surface 304 and the inner surface sterile The outer surface 305 opposite to the surface 304, i.e. sterile The surgical drape 303 comprises a body having a surface 305, whereby the outer surface 305 of the surgical drape 303 is designed to face the surgeon, and the inner surface 304 of the sterile drape 303 is designed to face the non-surgical surface 305. sterile According to a preferred embodiment, the body of the surgical drape 303 is designed to face the non-surgical manipulandum 310 in order to maintain the sterility of the manipulandum 310. sterile A drape cavity portion 322 is formed to surround at least a portion of the manipulandum 310, such that the inner surface 304 of the drape 303 faces the cavity 322. The drape cavity 322 may be sealed or may be open to form an opening 331 for accessing the cavity 322, which leads from the cavity 322 to the outer surface 305 of the surgical drape 303.

[0054] The sterile master input handle assembly 302 has at least one sterile accessory 306 adapted to form a sterile interface for a surgeon's fingers of the sterile master input handle assembly 302. According to an embodiment, the at least one sterile accessory 306 forms a sterile hand grip for the sterile master input handle assembly 302.

[0055] The at least one sterile accessory 306 sandwiches the sterile surgical drape 303 and sterilePreferably, the mechanical engagement is sterile Do not tear the drape 303, in other words, sterile Accessory 306 is sterile While maintaining the integrity of the drape 303, sterile Across the drape 303 sterile It is mechanically engaged with manifold 310.

[0056] According to a preferred embodiment, the at least one sterile accessory 306 is made as a single piece, for example, from a molded polymer material that is harder and / or more rigid than the sterile drape 303. For example, the accessory 306 is made from a molded polymeric hard shell, for example, made from polyethylene, and / or polyurethane, and / or polyester.

[0057] According to a preferred embodiment, sterile The drape 303 is sandwiched between the sterile A connector 308 is provided on the accessory 306 for mechanically engaging with a manipulandum 310. The connector 308 may be integral with the accessory 306, and may be connected to the non- sterile It may be snapped onto the manipulandum 310 .

[0058] Advantageously, said at least one sterile accessory 306 covers at least a portion of the outer surface 305 of said surgical drape 303, thereby allowing at least a portion of the sterile drape 303 to intersect with said at least one accessory 306 and said non-sterile accessory 306. sterile This results in the manipulandum 310 being interposed between it and at least a portion of the manipulandum 310.

[0059] As a further advantage, the at least one sterile accessory 306 may be non-transparent across the sterile surgical drape 306. sterile It includes at least one interface surface 307 that forms the sterile interface for the surgeon's fingers to manipulate the manipulandum 310.

[0060] Thanks to these sterile accessories 306, draped non- sterile The manipulandum 310 can be easily handled by a surgeon, for example, with one hand.

[0061] At the same time, accessory 306 sterile and / or new procedures and / or new steps in the same procedure. sterile By providing accessory 306, the same non sterile The manipulandum 310 can be reused. Preferably, the attachment 306 is suitable for use in a sterile operating room, e.g., an autoclave. sterile By means sterile It is possible.

[0062] According to an embodiment, the at least one interface surface 307 faces the surgeon in use, and sterile Non-cross surgical drape 306 sterile for the surgeon's fingers to manipulate the manipulandum 310 sterile It is suitable for forming an interface.

[0063] The sterile master input handle assembly 302 is designed to receive manual commands for actuating a robotic slave assembly 330 of the master-slave teleoperated robotic microsurgical system 300 that is suitable for performing surgery, preferably microsurgery, on a patient's anatomy. According to an embodiment, the at least one sterile accessory 306 covers at least a portion of an outer surface 305 of a surgical drape 303, which in turn covers at least a portion of the sterile manipulandum 310. The sterile manipulandum 310 has or forms grip controls designed to control a pair of slave grip degrees of freedom of a robotically actuated slave surgical instrument 337 operatively connected to the sterile master input handle 302. This allows a surgeon to control a pair of slave grip degrees of freedom of a robotically actuated slave surgical instrument 337 operatively connected to the sterile master input handle 302 by acting, e.g., pushing, on the interface surface 307 of the accessory 306.

[0064] According to embodiments, the interface surface 307 of the sterile accessory 306 is a friction surface, e.g., a friction surface having a predetermined surface roughness above a threshold value greater than the surface roughness of the outer surface of the surgical drape 303. According to embodiments, the interface surface 307 of the sterile accessory 306 defines one or more bosses 354 and / or recesses 354', such as bumps 354 and / or valleys 354', to facilitate a surgeon's grip. According to embodiments, the interface surface 307 of the sterile accessory 306 defines one or more cuts 327 or notches 327 to facilitate a surgeon's grip and grip thereon. According to embodiments, the interface surface 307 of the sterile accessory 306 is wrinkled or wavy to facilitate a surgeon's grip and grip. According to embodiments, the sterile accessory 306 includes cuts 327, notches 327, or incisions 327 that locally interrupt the continuity of the interface surface 307. This further increases the friction of the interface surface 307. For example, the cuts 327 or incisions 327 extend transversely to the longitudinal extension of the sterile accessory 306. According to embodiments, the interface surface 307 is molded to present a rough surface finish. According to embodiments, the interface surface 307 is treated to increase its friction. For example, the surface roughness of the functional surface 307 may be increased by a surface treatment of the sterile accessory 306.

[0065] According to an embodiment, the at least one sterile accessory 306 and the sterile surgical drape 303 are detachably associated with each other. According to an embodiment, the at least one sterile accessory 306 and the sterile surgical drape 303 are made of different materials. According to an embodiment, the at least one sterile accessory 306 and the sterile surgical drape 303 are locally (preferably detachably) associated with each other as a result of at least a portion of the sterile drape 303 being interposed between a portion of the sterile manipulandum 310 and the at least one accessory 306, with the accessory 306 and the sterile manipulandum 310 mechanically engaged. In other words, preferably, the accessory 306 is sterile It does not stick to the outer surface 305 of the drape 303 . sterile The drape 303 is at least partially sterile The retention effect exerted by the mechanical engagement of the accessory 306 with the manipulandum 310 allows the non- sterile is held locally to at least a portion of the manipulandum, whereby sterile At least one localized stress may be generated in the drape 303. sterile Accessories sterile There is no need to provide an attachment means for attaching to the drape 303. sterile For these reasons, the drape 303 is less fragile in use and can be made thinner and more consistent in thickness. The connector 308 of the sterile accessory 306 can function as a local retention element for at least a portion of the surgical drape 303 relative to the manipulandum 310. sterile Accessory 306 sterile It is not attached to the drape 303. sterile By virtue of being engaged with the manipulandum 310 across the thickness of the drape 303, it is possible to fix the interface surface 307 and the active portion of the manipulandum 310 in a predetermined relative position and spatial orientation.

[0066] According to embodiments, the sterile accessory 306 is integral with the surgical drape 303, for example as shown in Figure 11, and preferably the sterile accessory 306 is integral with the outer surface 305 of the surgical drape 303. For example, the sterile accessory 306 is welded or glued to the outer surface 305 of the surgical drape 303.

[0067] The connector 308 may be integral with the sterile drape 303 and simultaneously releasably engage the manipulandum 310 while maintaining the integrity of the sterile drape 303 .

[0068] According to a preferred embodiment, the sterile surgical drape 303 is sandwiched between the at least one sterile accessory 306 and the non-sterile surgical drape 303. sterile The mechanical engagement between the manipulandum 310 locks the position and spatial orientation of the manipulandum 310 relative to the interface surface 307 of the accessory 306 in a predetermined configuration. Preferably, the locking of position and spatial orientation is achieved by: sterile The integrity of the drape 303, particularly the at least one sterile This is accomplished while maintaining the integrity of at least one portion of the drape 303 that is covered by the accessory 306 .

[0069] According to a preferred embodiment, the at least one sterile accessory 306 is arranged to sandwich the sterile surgical drape 303 between the non-sterile surgical drape 303 and the sterile surgical drape 303. sterile It is mechanically detachably engaged with the manipulandum 310. sterile Accessories 306 and the above sterile Drape 303 sterile or by disposal, sterile The manipulandum 310 may be reusable for multiple surgeries.

[0070] According to an embodiment, the non sterile The manipulandum 310 comprises at least one convex body 309, and said at least one sterileThe at least one connector 308 of the accessory 306 mechanically engages with the at least one convex body 309 .

[0071] According to a preferred embodiment, the at least one accessory 306 is sterile Manipulandum 310 and the sterile A surgical drape 303 is sandwiched and snapped into place.

[0072] According to a preferred embodiment, the connector 308 of the at least one accessory 306 is sterile The sterile accessory 306 includes at least one positioning clip for snap-fit ​​engagement with at least one undercut wall 329 on the body of the manipulandum 310. As shown, for example, in FIG. sterile The manipulandum 310 has a plurality of connectors 308 in the form of locating clips 308 each having a retaining element 329' protruding at or near its free end designed to interlock with a plurality of undercut walls 329 provided on a respective niche 355 of the manipulandum 310. By virtue of the provision of said niches 355, the sterile The drape 303 is sandwiched between the sterile Accessories 306 and the non sterile It is possible to prevent relative slippage between the manipulandum 310 and the sterile The retaining element 329' of the connector 308 of the accessory 306, the undercut wall 329 and the non- sterile The cooperation between the niches 355 of the manipulandum 310 sterile Manipulandum 310 and the above sterile This creates an interlocking arrangement that can prevent relative movement, such as relative longitudinal sliding, between the accessory 306 and the interface surface 307 .

[0073] To adjust the elastic properties of such a positioning clip of said connector 308 of the sterile accessory 306, a cut 327 may be provided in the accessory 306. The sterile accessory 306, and in particular at least one interface surface 307, may be made of a rubbery material to facilitate the grip of the surgeon's fingers thereon. Preferably, sterile The accessory 306 sterile To mechanically engage with the manipulandum 310, sterile Accessory 306 is a non sterile Draping the Manipulandum 310 sterile placed on a portion of the outer surface 305 of the drape 303, and then sterile At least one positioning clip of the accessory 306 is sterile Pressure is applied to the interface surface 307 of the sterile accessory to urge the connector 308 into a snap fit with at least one respective undercut wall 329 of the manipulandum 310. To facilitate such mechanical engagement, at least one leading wall 356 is provided on the sterile Across the drape 303 sterile designed to mechanically engage with the manipulandum 310, sterile The connector 308 may be provided on or near the connector 308 of the accessory 306. sterile To prevent tearing of the drape 303, the at least one guide wall 356 may be sterile When contacting the outer surface 305 of the drape 303 sterile The drape 303 may have a substantially rounded surface without any cut edges that could tear the drape 303 .

[0074] According to an embodiment, the plurality of positioning clips of the at least one connector 308 are non- sterile The at least one connector 308 is adapted to engage, preferably to form a reversible snap-fit ​​engagement, with the at least one convex body 309 of the manipulandum 310. Preferably, the at least one connector 308, for example consisting of a plurality of positioning clips, sterileNon-cross drape 303 sterile The at least one connector 308 of the sterile accessory 306 has an arcuate concave surface 321 facing the outer surface 305 of the surgical drape 303 suitable for receiving the convex body 309 of the manipulandum 310. For example, the arcuate concave surface 321 of the at least one connector 308 of the sterile accessory 306 describes a substantially "C" profile. sterile The accessory 306 itself is sterile to fit the shape of the convex body 309 of the manipulandum 310. sterile It may have an arcuate concave surface 321 that holds a portion of the drape 303 in place.

[0075] The at least one sterile accessory 306 may be in the form of a bell or cap that surrounds the sterile drape 303 .

[0076] The non-sterile drape 303 is sandwiched between the at least one sterile accessory 306 and the sterile drape 303. sterile The mechanical engagement between the manipulandum 310 may be other than a snap-fit ​​engagement. sterile The connector 308 of the accessory 306 is sterile The drape 303 is sandwiched between the sterile The manipulandum 310 has at least one male element that mechanically engages with at least one respective female element. sterile Accessories 306 and non- sterile The manipulandum 310 may be attached by force or interference fit engagement. sterile According to an embodiment, at least one sterile Accessories 306 and non sterile The Manipulandum 310 can be attached to the table by screwing or nailing the connection. sterile It is mechanically engaged across the drape 303 .

[0077] According to embodiments, the at least one sterile accessory 306 comprises a second surface 328, or inner surface 328, facing the outer surface 305 of the surgical drape 303. According to embodiments, the second surface 328 is opposite the at least one interface surface 307 with respect to the body of the accessory 306, as shown, for example, in FIG. 4. The second surface 328 preferably has a concave shape that forms a concave seat 353 or cavity 353 for receiving the convex body 308 (or at least a portion thereof) and a portion of the surgical drape 303 secured therebetween (e.g., sandwiched or confined therebetween).

[0078] According to an embodiment, the at least one interface surface 307 of the at least one sterile accessory 306 has a convex shape. The convex shape of the at least one convex interface surface 307 may be realized in a direction transverse to a main longitudinal extension direction of the interface surface 307 to facilitate a rolling movement of the sterile input handle assembly 302 between the fingers of one hand of a surgeon during robotic surgery.

[0079] According to an embodiment, the at least one attachment 306 has an elongated shape in a longitudinal direction that substantially matches the convex body 309 and a convex shape transverse to the longitudinal direction. According to an embodiment, the at least one interface surface 307 of the at least one attachment 306 has a bulge shape, exposing a substantially spherical cap surface to the surgeon's finger.

[0080] According to an embodiment, the non sterile The at least one convex body 309 of the manipulandum has at least one convex surface 313 such that the arcuate concave surface 321 of the accessory 306 substantially matches the convex surface 313 to form the sterile It is captured between the layers of the drape 303. According to an embodiment, sterile The body of the drape 303 is in contact with the arcuate surface 321 of the clip 308 of the accessory 306 and the non- sterileIt is sandwiched between said convex surface 313 of the convex body 309 of the manipulandum 310, preferably in contact with both.

[0081] According to a preferred embodiment, sterile The master input handle assembly 302 has at least two sterile Accessory 306 (i.e., the first sterile Accessories and Secondary sterile accessories) to have a further or second sterile and an accessory 306. sterile The accessory 306 is sterile In cooperation with the manipulandum 310, the surgeon's fingers sterile The non-surgical drape 303 is sterile Two or more opposing interface surfaces 307 are provided to allow for grasping and firm holding of the manipulandum 310. Preferably, the opposing interface surfaces 307 are non- sterile The non-contact points on opposite sides of the body of the manipulandum 310 sterile At least two opposing sterile accessories 306 are provided on opposite sides of the manipulandum 310, whereby at least two opposing sterile accessories 306 have grip controllers designed to control opposing slave grip degrees of freedom of a robotically actuated slave surgical instrument 337 operatively connected to said sterile master input handle 302, or non-sterile accessories 306 that cooperate together. sterile Covering at least two opposing portions of the manipulandum 310 makes actuation of the gripping degree of freedom of the slave surgical instrument 337 robotically actuated for the surgeon more intuitive.

[0082] According to an embodiment, the sterile drape 303 includes at least one pouch 312, 312′ that receives at least a portion of the manipulandum 310 of the master input handle assembly 302. The at least one pouch 312, 312′ is at least a portion of the cavity 322 defined by at least one sleeve 323, 323′ of the surgical drape 303 and having a closed end 352.

[0083] According to an embodiment that may not necessarily be combined with any of the above-described embodiments, for example as shown in FIG. sterile Drape 303 is a non sterile The manipulandum 310 has a pair of pouches 312, 312' each of which receives at least a portion of the manipulandum 310. Thus, each pouch 312, 312' of the pair of pouches 312, 312' is sterile The pouches 312, 312' receive a portion of the manipulandum 310 and are in fluid communication with each other. In other words, the body of the single surgical drape 303 defines a cavity 322 having two pouches 312, 312', preferably defined by a pair of sleeves 323, 323', each connected to a respective closed end 352. A drape joint 351 may be formed in the surgical drape 303 at or near the pouch opening 357 of each pouch 312, 312'.

[0084] According to another embodiment, for example as shown in FIG. sterile The drape 303 has two pouches 312, 312' that are made as separate pieces. sterile The drape 303 has multiple drape pieces. Each one of the pouches 312, 312′ is bounded by a sleeve 323, 323′ having a closed end 352 and an opposing pouch opening 357. The pouch opening 357 can coincide with the drape opening 331 of each single drape piece.

[0085] According to an embodiment, the at least one sterile accessory 306, when covered by the surgical drape 303, is non- sterile In order to make the manipulandum 310 safer to operate, a sterile drape 303 is sandwiched between the manipulandum 310 and the sterile drape 303, which is at least partially non-transparent. sterile It is in the form of a cheek surrounding at least one convex body 309 of the manipulandum 310. According to an embodiment, said at least one sterile accessory 306 in the form of a cheek defines a recessed seat 353 facing and preferably in contact with the outer surface 305 of the sterile drape 303, the recessed seat 353 being designed to receive a portion of the manipulandum 310.

[0086] According to an embodiment, the sterile master input handle assembly 302 has at least one degree of freedom between said two opposing interface surfaces 307, 307'. Said at least one degree of freedom may be a grip GM, GM' degree of freedom designed to control the mating slave degree of freedom of the grip GSL, GSL' of the slave surgical instrument 337, 337'. To actuate the grip degree of freedom, the two opposing interface surfaces 307, 307' may be moved towards each other by, for example, the application of a pressing action by the surgeon's fingers 318. Said degree of freedom between the two opposing interface surfaces 307, 307' may be achieved by a non-contact mechanism consisting of two parts 316, 316', one of which is movable relative to the other, for example, two articulated parts and / or press buttons and / or two parts slidably associated with each other. sterile It may be defined by the manipulandum 310.

[0087] According to an embodiment, said degree of freedom between the two opposing interface surfaces 307, 307' is defined by at least one accessory 306 itself, for example by a deformable bridge 345 between the two opposing interface surfaces 307, 307' of the accessory 306, as shown in Figure 14. Said degree of freedom between the two opposing interface surfaces may be an elastically loaded degree of freedom. For example, the deformable bridge 345 between the two accessories is an elastically deformable bridge, for example consisting of or made of a leaf spring.

[0088] According to an embodiment, the elastic action of the elastically loaded degree of freedom urges the two opposing interface surfaces 307, 307' away from each other.

[0089] In at least one configuration, the two opposing interface surfaces 307, 307' together define a convex cylindrical geometric shape, as shown, for example, in Figure 13. For example, when the sterile master input handle assembly 302 is in a closed configuration, the closed configuration is sterile This may be obtained by moving the two articulating portions and / or the two opposing interface surfaces 307, 307' of the manipulandum 310 towards each other. The two opposing interface surfaces together define a convex, cylindrical shape. The provision of such a convex cylindrical shape is advantageous for rolling the sterile master input handle assembly between the surgeon's fingers 318 of the surgeon's hand 319. The two opposing sterile accessories may be made in a single piece, in other words, the two sterile accessories may be monoblock.

[0090] According to a preferred embodiment, the non sterile The manipulandum 310 comprises at least a pair of elongated elements 316, 316 hinged to each other to form a tool joint 317, for example a pin joint 317. Preferably, said elongated elements 316, 316' are rigid. According to a preferred embodiment, the term "rigid" means that such a body lacks or is devoid of flexibility. According to an embodiment, the term "rigid" means that such a body cannot elastically provide bending deformation when in an operating state. According to an embodiment, sterile The drape 303 is made of a material that allows relative movement between the elongated elements 316, 316' of the manipulandum 310, thereby sterile Drape 303 is flexible or at least partially flexible, allowing spatial movement of manipulandum 310 and movement in each and every degree of freedom of the manipulandum, such as its grasping degree of freedom.

[0091] Thereby, the sterile drape 303 has one or more pairs of pouches 312, 312', so that the pair of elongated elements 316, 316' can be individually housed in the respective pouches 312 or 312'.

[0092] According to an embodiment, sterile The drape 303 includes a bifurcation from which the pair of pouches 312, 312' extend distally.

[0093] According to an embodiment, the non sterile At least one of the elongated elements 316, 316′ of the manipulandum 310, and preferably each of said elongated elements 316, 316′, has at least one convex body 309. Thereby, said at least one convex body 309 is part of at least one elongated element 316, 316′ of said master input tool 310.

[0094] According to an embodiment, the at least one elongated element 316, 316', preferably each of the elongated elements 316, 316', comprises a groove 324 located along its at least one convexity 309, so that the sterile accessory 306 is not sterile The manipulandum 310 is designed to accommodate at least a portion of the yielding body of the surgical drape 303 when mechanically engaged with a portion of the manipulandum 310. For example, wrinkles in the surgical drape 303 may be non- sterile Find space within the groove 324 of the manipulandum 310, sterile Accessories 306 Non sterile Mechanical engagement to the manipulandum 310 may be advantageous.

[0095] According to an embodiment, the at least one elongate element 316, 316′, preferably each of the elongate elements 316, 316′, defines a sensor slot 325 for accommodating, preferably removably, at least a portion of a sensor. The slot 325 may constitute an abutment reference surface for the sensor in order to receive the sensor at a predefined precise position and / or orientation relative to the body of the elongate element 316, 316′. For example, the sensor is a tracking sensor suitable for cooperating with a tracking field generator 339 provided in the sterile surgical field 311, for example near or at the master console 350.

[0096] Master console 350 may include at least one tracking field generator that may be provided integrally with the surgeon, for example, the tracking field generator may be provided on a wearable item worn by the surgeon, such as a belt or bracelet, at least one tracking field generator may be provided on a surgical chair, or at least one tracking field generator may be provided on master console 350. Console 350 may comprise a tower for the surgeon to stand near console 350, and tracking system 339 may be integral with the tower of master console 350.

[0097] According to an embodiment, the groove 324 of the manipulandum 310 is also suitable for receiving a cable connection to the sensor when received in the slot 325. A cover 326 or lid 326 may be provided to cover the slot 325. A sensor slot seat may be provided on the second surface 328 of the sterile accessory 306 of a size and shape suitable to receive the sensor slot 325 with or without the lid 326, and the sensor slot seat may be in communication with the concave seat 353 and / or a portion thereof. sterile Covering the sensor slot 325 of the elongated elements 316, 316' of the manipulandum 310 sterilePortions of accessory 306 may lack connectors so as not to interfere with sensor detection of a sensor received in the sensor slot 325. Preferably, the sensor is a magnetic tracking sensor (i.e., a magnetometer) that cooperates with the tracking field generator.

[0098] According to an embodiment, the tracking system 339 is an optical tracking system including at least one camera, for example a set of stereo cameras, and the master input handle assembly 302 has at least one optical marker for the purpose of being optically tracked by the tracking system. The one or more slots 325 and / or the groove 324 may function as an optical marker.

[0099] According to an embodiment, the at least one accessory 306 is disposable, in other words, designed for single use in a sterile environment.

[0100] According to an embodiment, the at least one accessory 306 comprises: sterile It is designed to be reusable for multiple surgeries.

[0101] Non sterile The provision of such attachments 306 that form large friction surfaces 307 for the purpose of providing a surface for the surgeon's fingers to handle the manipulandum 310 allows for non-surgical use after one surgical session. sterile The need to discard the manipulandum 310 is thus avoided. sterile Manipulandum 310 is sterile By covering with drape 303 sterile Furthermore, by providing the attachment 306, the surgeon can sterile It feels like you can hold the Manipulandum 310 firmly and accurately.

[0102] By providing at least one such interface surface 307, the surgeon can alternate between microsurgery and robotic-assisted microsurgery during a single intervention without compromising the sterility of the sterile surgical field 311. This allows for non-invasive manipulation each time the surgeon switches from manual to robotic-assisted microsurgery or vice versa during a single intervention. sterile The need to discard the manipulandum 310 can be avoided.

[0103] According to a general embodiment, there is provided a robotic surgical master controller assembly 301 comprising at least one sterile master input handle assembly 302 according to any one of the embodiments described above, and a master console 350. The master controller assembly 301 is designed to control slave robot assemblies 330.

[0104] The master controller assembly 301 may be located remotely and the master console 350 may be located remotely.

[0105] The master controller assembly 301 may be draped and placed in the sterile operating field 311, with the master console 350 of the master controller assembly 301 being draped with a console drape 349.

[0106] According to an embodiment, the master controller assembly 301 is connected to a tracking system 339 that may reside in the master console 350, for example, at least a portion of the sterile master input handle assembly 302 within a predefined tracking volume, and / or a non-sterile master input handle assembly 302 within a predefined tracking volume. sterile The manipulandum 310 has an optical and / or magnetic tracking system suitable for tracking its position and / or orientation.

[0107] The master input handle assembly 302 may be designed to be mechanically ungrounded and unconstrained relative to the tracking system 339 of the master console 350 and / or relative to the master console 350 and to be hand-held by the surgeon.

[0108] According to an embodiment, a pair of mechanically ungrounded, mechanically unconstrained sterile Two master input handle assemblies 302 are provided. Each assembly is designed to be held by one hand of the surgeon, allowing the surgeon to hold two master input handles 302, one at a time, during robotic surgery. The two mechanically ungrounded, sterile master input handle assemblies 302 can, for example, individually control two paired slave surgical instruments 337 of the robotic surgical system 300.

[0109] According to a general embodiment, there is provided a robotic surgical system 300 suitable for microsurgery, comprising at least one sterile master input handle assembly 302 according to any one of the above-described embodiments.

[0110] Preferably, the robotic surgical system 300 includes at least one master console 350 .

[0111] According to a preferred embodiment, the robotic surgical system 300 further comprises a slave robot assembly 330. According to an embodiment, the slave robot assembly 330 comprises at least one surgical arm 334 that manipulates the surgical instrument 337. According to an embodiment, the slave robot assembly 330 comprises at least one micromanipulator 335 that manipulates the surgical instrument 337. Preferably, the at least one micromanipulator 335 is directly connected in series to the surgical arm 334 that manipulates the surgical instrument 337, forming a kinematic chain with the surgical arm 334. According to an embodiment, at least two micromanipulators 335 are directly connected in series to the surgical arm 334, forming at least two-branched kinematic chains with the surgical arm 334. According to an embodiment, the slave robot assembly 330 comprises at least one robot cart 336, and the at least one arm 334 extends from the robot cart 336.

[0112] According to an embodiment, the robotic surgery system 300 comprises a control unit. The tracking system 339 may belong to the control unit. The control unit may include at least the non- sterile The control unit is adapted to receive a position and orientation relative to the manipulandum 310 and is adapted to send command signals to the slave robot assembly 330 for actuating the surgical instrument 337. According to an embodiment, the control unit is adapted to receive a first command signal comprising information regarding the manual command and to send a second command signal comprising information regarding the manual command to the slave robot assembly 330 for actuating the surgical instrument 337.

[0113] The control unit preferably resides in the master console 350 .

[0114] According to an embodiment, the robotic surgical system 300, preferably the master console 350 of the robotic surgical system 300, detects the non-operating position via at least the position of a sensor housed in the slot 325 and / or the position of the slot 325. sterile It further comprises at least one tracking system 339 including a field generator adapted to detect the position and orientation of the manipulandum 310 within a predetermined tracking volume.

[0115] According to an embodiment, the at least one tracking system 339 generates the predefined tracking space by means of a magnetic field generator, e.g., a magnetic field generator and / or an optical camera set, e.g., the magnetic field generator is located integrally with the surgeon.

[0116] At least one slave drape 338 may be provided for draping at least a portion of the robot slave assembly 330 .

[0117] Preferably, the master manipulator 310 and / or the sterile master input handle 302 controls a slave robotic surgical system 300 that actuates at least the gripping degree of freedom of an articulated end effector located at or near the distal end of the shaft of a surgical instrument 337.

[0118] The sterile master input handle 302 can also control the positioning of the slave robot assembly 330 by means of controlling the at least one micromanipulator 335, which is preferably a Cartier-style manipulator having three orthogonal linear degrees of freedom. The manipulator 335 is preferably located upstream of the shaft of a surgical instrument 337. An articulated end effector located at or near the distal end of the shaft of the surgical instrument 337 may also define pitch and yaw degrees of freedom, which may be controlled by the sterile master input handle assembly 302. The articulated end effector of the surgical instrument 337 preferably defines pitch, yaw, and grip degrees of freedom, and the surgical instrument 337 may also define a roll degree of freedom relative to its shaft.

[0119] According to an embodiment, the robotic surgical system 300 further comprises at least one surgical microscope 342. A microscope drape 343 may be provided for draping at least a portion of the microscope 342.

[0120] According to a general embodiment, a sterile surgical field 311 is provided that includes at least one sterile master input handle assembly 302 according to any one of the embodiments described above.

[0121]

[0142] According to an embodiment, the sterile operating room field 311 further comprises at least a portion of at least one robotic slave manipulator 330 according to any one of the above-described embodiments, thereby, the sterile operating room field 311 further comprises at least a portion of at least one robotic surgical system 300 according to any one of the above-described embodiments.

[0122] According to an embodiment, the sterile operating room field 311 further comprises at least one operating room bed 341 that provides support for the anatomy of the patient to be treated.

[0123] According to a general embodiment, non sterileA surgical drape 303 for the master input handle assembly 302 is provided that includes a pair of pouches 312, 312′ integral therewith for individually receiving a pair of elongated elements 316, 316′ of the manipulandum 310. The surgical drape 303 may be configured to include one or more sterile The surgical drape 303 can be associated with an attachment 306. sterile The manipulandum 310 may be a non- sterile It may be a manipulandum 310.

[0124] The above-mentioned needs can be addressed by virtue of the above-mentioned features provided alone or in combination in particular embodiments, providing the above-mentioned advantages.

[0125] It becomes easier to control robotic surgical systems from a sterile environment, such as a sterile operating room.

[0126] Non sterile Manipulandum 310 sterile a non-transparent drape sheet adapted to receive manual commands from a surgeon via the drape sheet having at least one attachment that allows it to be confidently grasped by the surgeon across the barrier; sterile Includes manipulandum sterile A master controller is provided.

[0127] Non-contact lasers, which can constitute the most expensive features such as sensors, reference surfaces, optical markers, and rotary joints. sterile Contamination of the manipulandum 310 is avoided and it can therefore be used for several surgeries.

[0128] Non sterile Providing the assembly with a drape 303 for draping the manipulandum 310 allows for positioning the sterile master handle assembly 302 and surgeon within a sterile operating room field 311 near, for example, an operating bed 341 .

[0129] To do this, we need a master controller. sterile This eliminates the need for manual and robotic microsurgery, allowing the surgeon to alternate between manual and robotic-assisted microsurgery during a single intervention.

[0130] The draped, unconstrained master manipulandum can be moved freely in its entirety within the master working volume near the operating room bed, avoiding contamination of the master manipulandum.

[0131] The provision of such sterile accessories provides a solution that allows the master controller to be draped while maintaining sterility, while at the same time allowing for ease of operation of the master input tool when draped with a surgical drape.

[0132] At the same time, thanks to the connector 308 of the accessory 306, sterile Drape 303 is a non sterile This makes it easier to fit around the manipulandum 310.

[0133] It is envisioned that the master controller need not be disposable, even when handling the master input tool within a sterile operating room, as the master input tool can be draped for this purpose without losing the surgeon's grip.

[0134] Master Sterile Drape 303 is a non sterile The manipulandum 310 may have a loose body that drapes air other than the manipulandum 310, and thus, by virtue of the provision of the at least one connector 308, it is possible to drape a portion of the drape 303 in a non- sterile Constraints are permitted on a portion of the manipulandum 310, preferably at or near at least one of its convex bodies 309.

[0135] Thereby, at the same time, the connector 308 sterile For Manipulandum 310 sterile The main body of the drape 303 is brought into close contact with the area, and the friction surface 307 is maintained.

[0136] Those skilled in the art may make numerous modifications, adaptations and substitutions of functionally equivalent elements to the above-described embodiments to meet fortuitous and particular needs, but without departing from the scope of the appended claims. [Explanation of symbols]

[0137] 300 Robotic surgery system or robotic microsurgery system 301 Master Workstation of Robotic Surgery System 302 Master sterile Handle Assembly 303 Surgical drapes, or sterile drapes, or drapes 304 sterile Inside the drape sterile surface 305 Outer sterile surface of sterile drape 306 sterile accessories, or attachments 307 sterile Accessory interface or surface 308 sterile Accessory Connectors 309 Manipulander's protrusion 310 Master sterile Handle assembly non- sterile Manipulandum 311 Sterile operation section 312, 312' sterile Draped pouch 313 Convex surface of a convex body 316, 316' elongated elements of the manipulandum 317 Joints 318 Surgeon's Finger 319 Surgeon's Hands 320 workload 321 Arched Clip Surface 322 Drape Cavity 323, 323' draped sleeves 325 sensor slots 326 Covers or lids 327 cut or notch 328 Accessories Side 2 329 Undercut Wall 329' holding element 330 Slave Robot Assembly 331 Drape opening 334 Robot Arm 335 Manipulator 336 Robot Cart 337 Surgical instruments 338 Slave Drape 339 Tracking System 341 Operating Bed 342 Surgical microscope 343 Microscope Drape 345 Bridge 349 Master Console Drape 350 Master Console 351 sterile Drape joint 352 sterile Drape closed end 353 Accessory concave seat 353' Sensor slot seat or cavity 354 Accessory Bump 354' Accessory recess 355 Niche 356 Invitation Wall 357 bag openings

Claims

1. A sterile master input handle assembly (302), comprising: a non-sterile manipulandum (310); a sterile surgical drape (303) for draping the non-sterile manipulandum (310); the sterile master input handle assembly (302) is not mechanically grounded and is designed to be tracked by a tracking system (339) to determine the position and / or orientation of the sterile master input handle assembly (302) within a predefined workspace (320) for controlling at least one paired slave surgical instrument (337); the sterile master input handle assembly (302) further comprises at least one sterile accessory (306) adapted to form a sterile interface of the sterile master input handle assembly (302) for a surgeon's finger; the at least one sterile accessory (306) mechanically engages the non-sterile manipulandum (310) across the sterile surgical drape (303); the at least one sterile accessory (306) covers at least a portion of the outer surface (305) of the sterile surgical drape (303); the at least one sterile accessory (306) includes at least one interface surface (307) that forms the sterile interface for a surgeon's fingers to manipulate the non-sterile manipulandum (310) across the sterile surgical drape (303); The at least one sterile accessory (306) forms a sterile hand grip. the sterile master input handle assembly (302) includes, in addition to the at least one sterile accessory (306), a second sterile accessory; the at least one sterile accessory (306) and the further second sterile accessory provide two opposing interface surfaces (307, 307') for the surgeon's fingers to grasp the non-sterile manipulandum (310) across the sterile surgical drape (303); The sterile master input handle assembly (302) has a degree of freedom between the two opposing interface surfaces (307, 307') that allows the two opposing interface surfaces (307, 307') to be moved closer to and farther apart from each other.

2. 2. The sterile master input handle assembly (302) of claim 1, wherein the at least one interface surface (307) is a friction surface having a predetermined value of surface roughness greater than the surface roughness of the outer surface (305) of the sterile surgical drape (303).

3. 3. The sterile master input handle assembly (302) of claim 1 or 2, wherein said at least one interface surface (307) is convex.

4. The at least one sterile accessory (306) comprises two sterile accessories; A sterile master input handle assembly (302) according to any one of claims 1 to 3, wherein one and the other of the two sterile accessories are provided on opposite sides of the non-sterile manipulandum (310) across from the non-sterile manipulandum (310).

5. 5. The sterile master input handle assembly (302) of any of claims 1 to 4, wherein said degree of freedom is an elastically loaded degree of freedom.

6. 6. The sterile master input handle assembly (302) of any of claims 1 to 5, wherein, in at least one configuration, the two opposing interface surfaces (307, 307') together define a convex cylindrical shape.

7. The sterile master input handle assembly (302) of claim 4, wherein said two sterile accessories are made as a single piece.

8. the non-sterile manipulandum (310) comprises at least one pair of elongated elements (316, 316') hinged to one another to form a tool joint (317); At least one of said at least one pair of elongated elements (316, 316') comprises at least one convex body (309); The sterile master input handle assembly (302) of any of claims 1 to 7, wherein said at least one sterile accessory (306) mates with said at least one convex body (309).

9. the non-sterile manipulandum (310) comprises at least one pair of elongated elements (316, 316') hinged to one another to form a tool joint (317); each of said at least one pair of elongated elements (316, 316') forming a convex body (309); The sterile master input handle assembly (302) of claim 4, wherein each of said two sterile accessories engages said convex body (309).

10. the sterile surgical drape (303) comprises a pair of pouches (312, 312') for respectively receiving at least one pair of the elongated elements (316, 316'); 10. The sterile master input handle assembly (302) of claim 8 or 9, wherein the sterile surgical drape (303) comprises a branch from which the pair of pouches (312, 312') extend distally.

11. 11. The sterile master input handle assembly (302) of any of claims 1 to 10, wherein the at least one interface surface (307) comprises a boss (354) and / or a valley (354') for receiving a surgeon's finger.

12. 12. The sterile master input handle assembly (302) of any of claims 1 to 11, wherein the at least one sterile accessory (306) snaps across the sterile surgical drape (303) and onto the non-sterile manipulandum (310).

13. 13. The sterile master input handle assembly (302) of any of claims 1 to 12, wherein the at least one sterile accessory (306) mechanically and releasably engages the non-sterile manipulanda (310) across the sterile surgical drape (303).

14. 14. The sterile master input handle assembly (302) of any of claims 1 to 13, wherein the at least one sterile accessory (306) is integral with the sterile surgical drape (303) and is welded or glued to the sterile surgical drape (303).

15. A robotic surgery system (300), comprising: At least one sterile master input handle assembly (302) according to any one of claims 1 to 14; A robotic surgical system (300) having at least one slave robot assembly (330) including at least one surgical instrument (337).

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