Sterile master input handle assembly for robotic surgical systems and surgical drape for sterile master input handle

Abstract

A sterile master input handle assembly (302) comprises: a non-sterile manipulator (310); a sterile surgical drape (303) covering said non-sterile manipulator (310); at least one sterile accessory (306) adapted to form a sterile interface for a surgeon's finger of a sterile master input handle assembly (302); wherein: said at least one sterile accessory (306) is mechanically interfacing said non-sterile manipulator (310) over said sterile surgical drape (303); said at least one sterile accessory (306) covers at least a portion of an outer surface (305) of the sterile surgical drape (303); said at least one sterile accessory (306) comprises at least one surface (307) forming said sterile interface for a surgeon's finger to manipulate the non-sterile manipulator (310) over said sterile surgical drape (303).

Description

TECHNICAL FIELD

[0001] It is an object of the present application a sterile master input handle assembly.

[0002] The sterile master input handle assembly is suitable for robotic surgery.

[0003] The present application also relates to a master controller assembly comprising at least one sterile master input handle assembly and a master console.

[0004] The present application also relates to a robotic surgery system comprising at least one sterile master input handle assembly.

[0005] Furthermore, the present disclosure relates to a surgical drape for a sterile master input handle. BACKGROUND

[0006] Robotic surgery devices are used in robotically assisted surgery and generally comprise a surgeon master console for receiving manual commands from a surgeon, a robot slave central tower (or robot cart) and a plurality of robot slave arms carrying one or more surgical instruments (end effectors) extending from the slave central tower and controlled through the surgeon master console. The one or more slave surgical instruments are attached at a distal end to the robot slave arms in order to perform a surgical procedure on a patient within a sterile surgical field. Typically, a surgical drape is provided to cover non-disposable parts of the robotic device in order to avoid contamination of the sterile surgical field that can be caused by the robotic surgery device. Straps and strings can be provided on the outer surface of the surgical drape in order to tie the drape around the robot, thus reducing the bulk of the drape and making it substantially tight-fitting.

[0007] For example, documents WO-2017-064301 and WO-2018-189729 disclose solutions for robotic surgery systems suitable for miniaturizing surgical instruments, especially for robotically assisted microsurgery. Traditional (non-robotic) microsurgery requires the surgeon to perform the surgery using a surgical microscope (typically an optical microscope) that can magnify the surgical field, so a robotic surgery device for microsurgery is suitably equipped with a surgical microscope. Surgical drapes for covering the microscope have been provided, for example as shown in documents US-2019-0069969 and JP-6367019.

[0008] Microsurgery procedures are performed in several phases of biological tissue reconstruction, for example, in the execution of vascular anastomosis including small diameter blood vessels and nerves, and in the reconstruction of anatomic parts after traumatic injuries, in the re-vascularization of tissues, in the reattachment of limbs, in transplantation and replantation procedures. In the field of microsurgery, robotic devices allow a high miniaturization of the surgical instruments, and at the same time allow to reduce the tremor transmitted to the robotic surgery system from the surgical instruments, when compared to traditional microsurgery.

[0009] Robotic surgery devices are also applied to robotically assisted laparoscopy, in which the surgical instruments and at least one camera are inserted individually into the patient's body through a set of percutaneous trocars, and in which a visualization screen visualizes the laparoscopic images acquired from the camera inside the patient's body. Thanks to the robotic assistance, the fulcrum effect, which occurs because during the manipulation of traditional (non-robotic) laparoscopic surgical instruments a lever arm is formed across the length of each percutaneous rigid trocar, is reduced during surgery. Moreover, thanks to the robotic assistance, the laparoscopic surgeon is offered an improved comfort during surgery because of the ergonomic features of the surgeon master console.

[0010] Remote surgeon master consoles have been provided, for example as shown in documents US-2014-0018960 and EP-2845556. Typically, these remote surgeon master consoles comprise visualization devices, surgeon seats and / or surgeon forearm support elements, and master control handles in the form of accessories, which are articulated to the body of the master console to receive hand control instructions from the surgeon for controlling the slave surgical instruments. Thus, the comfort of the laparoscopic surgeon is further improved because he / she does not even need to go to the sterile area of the operating room to perform the surgery from a non-sterile remote location.

[0011] However, the great physical distance between the team in the sterile surgical area and the surgeon manipulating the master input accessories at the remote master console can create communication problems in the team during surgery, in particular with the surgeon.

[0012] Therefore, it is considered that the surgeon needs to go to the sterile surgical area even in the presence of a robotic surgery system.

[0013] Moreover, in some applications of robotically assisted microsurgery, it is desirable for the surgeon to be present within the sterile surgical field during the robotically assisted surgery. Therefore, during a single intervention, the microsurgeon can switch from robotically assisted microsurgery to traditional (non-robotic) microsurgery, holding a traditional microsurgical tool such as a forceps, and / or back to the surgeon master console.

[0014] For example, document US-2019-328473 shows a master console that can be covered by a sterile drape, which is attached to a sterile, exposed, constrained, electrically powered, rotatable mounting to the master input accessory of the master console during operation.

[0015] For example, document US-10512515 shows a non-sterile master input handle with a hand-shaped trackball and integrated display, which can be covered by a sterile drape. Document US-8368649 shows a similar solution, in which a sterile mouse pad is located above an active sensing base to drive a computerized medical device.

[0016] For example, document WO-2014-151621 discloses a system for alternating between manual surgery and robotic surgery using a mechanical non-grounded master controller designed to be hand-held by a surgeon. Wearable and mechanically non-grounded master controllers are also known, for example, from documents WO-2019-099854 and EP-2467082, and generally comprise a pair of rings to match the surgeon's fingers, which are integrally associated to the gripping command interface of the non-grounded master controller.

[0017] Furthermore, documents WO-2019-220407, WO-2019-220408, and WO-2019-220409, under the same applicant, disclose several embodiments of handheld master input handles that are mechanically ungrounded and mechanically unconstrained with respect to a main control console. This allows the handheld handles to move freely within a predetermined tracking volume relative to the console for controlling paired slave surgical instruments. These handheld master input handles include a master gripper with internal degrees of freedom to control paired gripping degrees of freedom of paired slave surgical instruments (e.g., needle holders from a surgical system). Recently, mechanically unconstrained master input handles of this type have emerged as advantageous solutions for controlling slave robotic surgical instruments because they allow for an increased range of motion for the surgeon and allow for scaling factors to be set so that large surgical movements are translated into small movements of the slave robotic surgical instruments. Tracking devices, such as optical or magnetic devices, can be integrally provided to the main control console to track the position and / or orientation of the mechanically unconstrained master input handle within the workspace. For this purpose, the main input handle can be equipped with optical markers and / or magnetometers.

[0018] However, unrestricted master input handles may require proper sterilization before and after use in a sterile environment, which can result in high costs. Alternatively, unrestricted master input handles can be designed for single use only, although they may also result in high costs due to their high technical sophistication and / or stringent manufacturing tolerances in order to be tracked with the highest level of spatial accuracy in their workspace.

[0019] It is believed that the following conflicting needs need to be balanced: to provide robotic surgery with a main input handle that can precisely control pairs of surgical instruments, while ensuring that the surgeon's hand has a large range of motion, and at the same time, the main input handle does not need to be disposable, or at least the technology of the parts of the main input handle that need to be disposable is minimized, thereby minimizing manufacturing costs and the materials used.

[0020] They also believe there is a need for a solution that allows surgeons to effectively alternate between robot-assisted and traditional manual surgery.

[0021] At the same time, it is believed that it is necessary to simplify the switching from robot-assisted surgery to traditional surgery during a single intervention, and vice versa. Summary of the Invention

[0022] The scope of this invention is to overcome the disadvantages mentioned with reference to known technologies and to provide a solution for a main input handle used in a sterile area.

[0023] The scope of this invention is to overcome the disadvantages mentioned with reference to known technologies and to provide a solution for covering a main input handle for use in a sterile area.

[0024] These or other ranges are achieved through the main input handle assembly, the main controller assembly, the robotic surgical system, and the surgical drape.

[0025] According to one aspect of the invention, a sterile master input handle assembly includes: a non-sterile manipulator; a sterile surgical drape covering the non-sterile manipulator; and at least one sterile accessory adapted to form a sterile engagement portion of the sterile master input handle assembly for a surgeon's finger.

[0026] According to one aspect of the invention, the at least one sterile accessory mechanically engages with the non-sterile manipulator across the sterile surgical drape, and the at least one sterile accessory covers at least a portion of the outer surface of the surgical drape, and the at least one sterile accessory includes at least one engagement surface forming the sterile engagement portion, so as to allow a surgeon's finger to manipulate the non-sterile manipulator across the sterile surgical drape.

[0027] The sterile master input handle assembly can be designed to be held by the surgeon during surgery. The surgeon can fully bear the weight of the handheld sterile master input handle assembly during surgery.

[0028] The sterile main input handle assembly may be mechanically ungrounded and includes features designed to be tracked by an associative tracking system to determine the position and / or orientation of the main input handle assembly within a predetermined working volume, thereby controlling at least one pair of surgical instruments. The working volume preferably incorporates a portion of the tracking system. Features designed to be tracked by the associative tracking system may include one or more optical markers and / or one or more magnetometers. The tracking system may be an optical tracking system including a camera array, and / or a magnetic tracking system including a magnetic field generator. The sterile main input handle assembly is preferably freely movable with respect to the tracking system. The sterile main input handle assembly is preferably designed to roll freely between the surgeon's fingers.

[0029] Two sterile master input handle assemblies can be set up, one for each of the surgeon's hands.

[0030] The mating surface of the sterile accessory can be a friction surface with a predetermined surface roughness greater than that of the outer surface of the surgical drape, in order to improve the surgeon's grip on the sterile main input handle assembly during surgery.

[0031] The mating surface of the sterile accessory can be a convex surface for use with one or more of the surgeon's fingers. This convex mating surface allows the surgeon to easily roll the sterile master input handle assembly while it is held by the surgeon's hand.

[0032] The sterile main input handle assembly may include an additional second sterile attachment to include at least two sterile attachments on a single main input handle assembly. That is, the two sterile attachments engage with a single non-sterile manipulator over the surgical drape, thereby providing at least two opposing engagement surfaces for the surgeon's fingers to grasp the non-sterile manipulator over the sterile surgical drape. Preferably, the sterile main input handle assembly is designed to be held by the surgeon with one hand during surgery. The two sterile attachments may be positioned on opposite sides of the non-sterile manipulator. The two sterile attachments may be positioned opposite each other with respect to the body of the non-sterile manipulator so that the two convex engagement surfaces are exposed in opposite directions, such that the two convex engagement surfaces are back-to-back with each other.

[0033] The sterile main input handle assembly may include at least one degree of freedom between the two opposing engagement surfaces. This at least one degree of freedom may be a grasping degree of freedom designed to control a pair of grasping degrees of freedom from a surgical instrument. To drive the grasping degree of freedom, the two opposing engagement surfaces can be moved, for example, by applying pressure with the surgeon's fingers to move the two opposing engagement surfaces toward each other. The degree of freedom between the two opposing engagement surfaces may be defined by a non-sterile manipulator, which, for example, includes two parts movable about each other, such as two hinged portions and / or buttons and / or two parts slidably associated with each other. The degree of freedom between the two opposing engagement surfaces may be defined by at least one accessory itself, for example by a deformable bridging member between the two engagement surfaces.

[0034] The degree of freedom between these two opposing mating surfaces can be a compressive degree of freedom. For example, the deformable bridge between the two attachments is an elastically deformable bridge, which includes or is made of a leaf spring, for example.

[0035] In at least one configuration, the elastic action of the elastic compression degree of freedom causes the two opposing mating surfaces to deviate from each other.

[0036] In at least one configuration, the two opposing engagement surfaces together define a convex cylindrical geometry. For example, when the sterile main input handle assembly is in a closed configuration, which can be achieved by moving the two hinged portions and / or the two opposing engagement surfaces of a non-sterile manipulator toward each other, these two opposing engagement surfaces together define a convex cylindrical geometry. Such a convex cylindrical geometry facilitates the rolling of the sterile main input handle assembly between / among the surgeon's fingers in the surgeon's hand. The two opposing sterile attachments can be integral, that is, the two sterile attachments can be monolithic.

[0037] A non-sterile manipulator may include at least a pair of elongated elements hinged to each other to form a tool connector, wherein at least one of the elongated elements includes at least one protrusion; and wherein the at least one sterile attachment engages with the protrusion. Each of the elongated elements may include the protrusion, and the sterile attachment may engage with the protrusion of each of the elongated elements.

[0038] At least one mating surface may include protrusions and / or valleys to accommodate the surgeon's fingers.

[0039] According to one aspect of the invention, a main controller assembly includes at least one sterile main 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 main input handle assembly. The tracking system may be part of the main control console of the main controller assembly to track the position and / or orientation of the sterile main input handle assembly relative to the main control console. The main controller assembly may include a pair of sterile main input handle assemblies.

[0040] According to one aspect of the invention, a robotic surgical system includes at least one sterile master input handle assembly and at least one slave robot assembly, the at least one slave robot assembly including at least one surgical instrument. The surgical instrument may include a gripping degree of freedom controlled by the master input handle assembly.

[0041] According to one aspect of the invention, a robotic surgical system includes a master controller assembly and at least one slave robot assembly, the at least one slave robot assembly including at least one surgical instrument. The surgical instrument may include a gripping degree of freedom controlled by a master input handle assembly.

[0042] According to one aspect of the invention, a surgical drape for a main input handle assembly includes a pair of bags for accommodating, respectively (i.e., individually), a pair of elongated elements of a non-sterile manipulator. The surgical drape may include a bifurcation from which the pair of bags extend distally. The pair of bags may extend distally from the bifurcation.

[0043] As a result of the proposed solution, the non-sterile manipulator is designed to receive manual commands from the user (i.e., the surgeon) in a sterile surgical area and can be reused for multiple surgeries.

[0044] The proposed solution provides a main input handle assembly with a cover that shields a non-sterile manipulator. This assembly has a sterile attachment that can be attached to the manipulator to form a junction for the surgeon's fingers in a sterile surgical area. Furthermore, the manipulator, shielded by the sterile barrier assembly, exposes the junction surface to provide a stable grip for the surgeon's fingers on this surface during robot-assisted microsurgery.

[0045] The operational safety of the main controller used in robotic surgery is improved because the risk of the manipulator, which is covered by the surgical drape, slipping between the surgeon's fingers is reduced. Without this sterile accessory, the outer surface of the drape would be exposed to the surgeon's fingers.

[0046] The proposed solution is particularly applicable to (but not limited to) robot-assisted microsurgery. Furthermore, the proposed solution is particularly applicable to (but not limited to) microsurgical procedures that anticipate alternating manual and robot-assisted microsurgery. Attached Figure Description

[0047] Further features and advantages of the components and systems according to the invention will become apparent from the following description of preferred examples of embodiments given by way of indicative rather than limiting example with reference to the accompanying drawings, in which:

[0048] - Figure 1 An isometric view of a robotic surgical system suitable for microsurgery according to one embodiment is shown for illustration.

[0049] - Figure 2 An isometric view of a sterile main input handle assembly in a sterile operating area according to an embodiment is shown in illustration.

[0050] - Figure 3 A front view of a sterile main input handle assembly according to one embodiment is shown.

[0051] - Figure 4 An isometric view of a portion of a sterile main input handle assembly according to an embodiment is shown, the sterile main input handle assembly including a covered non-sterile manipulator and a sterile accessory shown as separate components;

[0052] - Figure 5 A plan view of an accessory according to one embodiment is shown;

[0053] - Figure 6An isometric view of a non-sterile manipulator according to one embodiment is shown;

[0054] - Figure 7 A surgical drape according to one embodiment is shown;

[0055] - Figure 8 This is an isometric view of a sterile main input handle assembly as a separate component according to one embodiment;

[0056] - Figure 9 and Figure 10 The image shows an isometric view of an elongated element in a corresponding surgical drape pouch within an elongated element of a non-sterile manipulator according to an embodiment.

[0057] - Figure 11 A surgical drape integrated with two accessories is shown according to one embodiment;

[0058] - Figure 12 A portion of a master-slave robotic surgical system according to one embodiment is shown, the system including two sterile master input handle assemblies when held by a surgeon within a work volume, and two slave surgical instruments;

[0059] - Figure 13 A sterile main input handle with a convex cylindrical geometry at the mating surfaces, according to one embodiment, is shown.

[0060] - Figure 14 An isometric view of an accessory of a sterile main input handle assembly according to one embodiment is shown. Detailed Implementation

[0061] According to a general embodiment, a sterile main input handle assembly 302 for a robotic surgical system 300 includes a non-sterile manipulator 310 and a sterile surgical drape 303 covering the non-sterile manipulator 310.

[0062] According to a preferred embodiment, the non-sterile manipulator 310 is a non-sterile master controller for a master-slave robotic surgical system 300.

[0063] According to a preferred embodiment, the non-sterile manipulator 310 is not, by itself, suitable for repeated use in sterile environments such as sterile surgical areas 311.

[0064] According to a preferred embodiment, the non-sterile manipulator 310 has a body suitable for being held by a surgeon.

[0065] Although, according to a preferred embodiment, the non-sterile manipulator 310 is mechanically ungrounded, the non-sterile manipulator 310 is not necessarily mechanically ungrounded due to the main control console 350 of the robotic surgical system 300.

[0066] According to a preferred embodiment, the non-sterile manipulator 310 is mechanically ungrounded and mechanically unconstrained by the robotic surgical system 300, and the non-sterile manipulator 310 is designed to cooperate with the tracking system 339 (e.g., an optical and / or magnetic tracking system) of the robotic surgical system 300, such that the position and / or orientation of the non-sterile manipulator within a predetermined working volume 320 can be tracked by the tracking system 339 to control the pair of surgical instruments.

[0067] The sterile drape 303 may be a movable or tightly fitted thin-layer surgical covering material, or it may be partially movable and partially tightly fitted, and the sterile drape may be made of, for example, a polymer material. For example, the main body of the surgical drape 303 may be made of a flexible sheet such as polyethylene, and / or polyurethane, and / or polyester.

[0068] According to one embodiment, the sterile drape 303 includes a body having an inner surface 304 (or a non-sterile surface 304) and an outer surface 305 (or a sterile surface 305) opposite the non-sterile inner surface 304. Thus, 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-sterile manipulator 310. According to a preferred embodiment, the body of the surgical drape 303 forms a drape cavity 322 for closing at least a portion of the non-sterile manipulator 310 to maintain the sterility of the non-sterile manipulator 310. Therefore, the inner surface 304 of the drape 303 faces the cavity 322. The drape cavity 322 can be sealed or opened to form a drape opening 331 leading into and out of the cavity 322 and through to the outer surface 305 of the surgical drape 303.

[0069] The sterile main input handle assembly 302 includes at least one sterile attachment 306 adapted to form a sterile engagement portion of the sterile main input handle assembly 302 for a surgeon's finger. According to one embodiment, the at least one sterile attachment 306 forms a sterile grip of the sterile main input handle assembly 302.

[0070] The at least one sterile accessory 306 mechanically engages with the non-sterile manipulator 310 over the sterile surgical drape 303. Preferably, the mechanical engagement does not tear the sterile drape 303; that is, the at least one sterile accessory 306 mechanically engages with the non-sterile manipulator 310 over the sterile drape 303 while maintaining the integrity of the sterile drape 303.

[0071] According to a preferred embodiment, the at least one sterile accessory 306 is integrally formed, for example, made of a molded polymer material that is stronger and / or more rigid than the sterile drape 303. For example, accessory 306 is made of a rigid shell (e.g., a molded polymer rigid shell), which is made of, for example, polyethylene, and / or polyurethane, and / or polyester.

[0072] According to a preferred embodiment, the accessory 306 is provided with a connector 308 to mechanically engage with the non-sterile manipulator 310, passing over the sterile drape 303. The connector 308 may be integral with the accessory 306 and may snap into the non-sterile manipulator 310.

[0073] Advantageously, the at least one sterile accessory 306 covers at least a portion of the outer surface 305 of the surgical drape 303. Thus, at least a portion of the sterile drape 303 is located between the at least one accessory 306 and at least a portion of the non-sterile manipulator 310.

[0074] Regarding an additional advantage, the at least one sterile accessory 306 includes at least one engagement surface 307, which forms the sterile surface for a surgeon's fingers to pass over the sterile surgical drape 306 to manipulate the non-sterile manipulator 310.

[0075] Because of this sterile accessory 306, the covered non-sterile manipulator 310 can be made easier for the surgeon to operate, for example, by the surgeon with one hand.

[0076] Simultaneously, the same non-sterile manipulator 310 can be reused by sterilizing the attachment 306 and / or by providing a new sterile attachment 306 for a new surgery and / or a new step in the same surgery. Preferably, the attachment 306 can be sterilized using sterilization tools in a sterile operating room (e.g., an autoclave).

[0077] According to one embodiment, the at least one engagement surface 307 is adapted to face the surgeon and to form the sterile engagement portion so that, in use, the surgeon's fingers can pass over the sterile surgical drape 306 to manipulate the non-sterile manipulator 310.

[0078] The sterile master input handle assembly 302 is designed to receive manual commands for driving a slave robot assembly 330 in a master-slave remotely controlled robotic microsurgery system 300, which is suitable for performing surgery (preferably microsurgery) on a patient's tissue structures. According to one embodiment, the at least one sterile attachment 306 covers at least a portion of the outer surface 305 of a surgical drape 303, which in turn covers at least a portion of the non-sterile manipulator 310 having or forming a grip controller designed to control paired slave grip degrees of freedom of the robotically driven slave surgical instrument 337 operably connected to the sterile master input handle assembly 302. Therefore, the surgeon can control the paired slave grip degrees of freedom of the robotically driven slave surgical instrument 337 operably connected to the sterile master input handle assembly 302 by applying actions (e.g., pressing or pushing) to the engagement surface 307 of the attachment 306.

[0079] According to one embodiment, the mating surface 307 of the sterile accessory 306 is a friction surface, for example, a friction surface having a surface roughness of a predetermined value above a certain threshold, the predetermined surface roughness being greater than the surface roughness of the outer surface of the surgical drape 303. According to one embodiment, the mating surface 307 of the sterile accessory 306 defines one or more protrusions 354 and / or recesses 354', such as bumps 354 and / or valleys 354', to facilitate gripping by the surgeon. According to one embodiment, the mating surface 307 of the sterile accessory 306 defines one or more incisions 327 or grooves 327 to facilitate gripping by the surgeon. According to one embodiment, the mating surface 307 of the sterile accessory 306 is wrinkled or pleated to facilitate gripping by the surgeon. According to one embodiment, the sterile accessory 306 includes incisions 327, grooves 327, or incisions 327 that partially interrupt the continuity of the mating surface 307. This further increases the friction of the mating surface 307. For example, the cut 327 or groove 327 extends laterally to the longitudinal extension line of the sterile accessory 306. According to one embodiment, the mating surface 307 is shaped to present a rough surface roughness. According to one embodiment, the mating surface 307 is treated to increase its friction. For example, the surface roughness of the mating surface 307 can be increased by surface treating the sterile accessory 306.

[0080] According to one embodiment, the at least one sterile accessory 306 and the sterile surgical drape 303 are detachably associated with each other. According to one embodiment, the at least one sterile accessory 306 and the sterile surgical drape 303 are made of different materials. According to one embodiment, the at least one sterile accessory 306 and the sterile surgical drape 303 are partially associated with each other (preferably detachably) because when the accessory 306 is mechanically engaged with the non-sterile manipulator 310, at least a portion of the sterile drape 303 is positioned between a portion of the non-sterile manipulator 310 and the at least one accessory 306. That is, preferably, the accessory 306 is not attached to the outer surface 305 of the sterile drape 303, and the sterile drape is partially held against at least a portion of the non-sterile manipulator by a holding action applied by the mechanical engagement of the sterile accessory 306 over at least a portion of the sterile drape 303 with the manipulator 310. Therefore, there is no need to provide an attachment tool that could generate localized stress on the sterile drape 303 for attaching at least one sterile accessory to it. Thus, the sterile drape 303 can be manufactured thinner and with a constant thickness without becoming too fragile in use. The connector 308 of the sterile accessory 306 can serve as a localized retaining element for bringing at least a portion of the surgical drape 303 into contact with the manipulator 310. Since the sterile accessory 306 is not attached to the sterile drape 303 but rather engages with the non-sterile manipulator 310 across the thickness of the sterile drape 303, the engagement surface 307 and the moving portion of the manipulator 310 can be locked in a predetermined relative position and spatial orientation.

[0081] According to one embodiment, for example, such as Figure 11 As shown, the sterile accessory 306 is integral with the surgical drape 303, 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 fused or bonded to the outer surface 305 of the surgical drape 303.

[0082] While maintaining the integrity of the sterile drape 303, the connector 308 can be integrated with the sterile drape 303 and simultaneously detachably engaged with the non-sterile manipulator 310.

[0083] According to a preferred embodiment, a mechanical engagement across the sterile surgical drape 303 between the at least one sterile accessory 306 and the non-sterile manipulator 310 locks the position and spatial orientation of the non-sterile manipulator 310 relative to the engagement surface 307 of the accessory 306 in a predetermined configuration. Preferably, this locking of position and spatial orientation is achieved while maintaining the integrity of the sterile drape 303, particularly while maintaining the integrity of at least a portion of the drape 303 covered by the at least one sterile accessory 306.

[0084] According to a preferred embodiment, the at least one sterile accessory 306 is mechanically engaged with the non-sterile manipulator 310 in a detachable manner across the sterile surgical drape 303. Therefore, the non-sterile manipulator 310 can be reused multiple times by sterilizing or discarding the sterile accessory 306 and the sterile drape 303.

[0085] According to one embodiment, the non-sterile manipulator 310 includes at least one protrusion 309, and the at least one connector 308 of the at least one sterile accessory 306 is mechanically engaged with the at least one protrusion 309.

[0086] According to a preferred embodiment, the at least one accessory 306 extends beyond the sterile surgical drape 303 and engages with the non-sterile manipulator 310.

[0087] According to a preferred embodiment, the connector 308 of the at least one accessory 306 includes at least one positioning clip for snap-fit ​​engagement with at least one undercut wall 329 disposed on the body of the non-sterile manipulator 310. For example, as Figure 4 As shown, the aseptic accessory 306 includes connectors in the form of multiple positioning clips 308, each connector having a retaining element 329' projecting at or near its free end. These retaining elements are designed to interlock with multiple undercut walls 329 disposed on a corresponding niche of the non-sterile manipulator 310. The niche 355 prevents relative sliding across the aseptic cover 303 between the aseptic accessory 306 and the non-sterile manipulator 310. According to one embodiment, the engagement between the retaining element 329' of the connector 308 of the aseptic accessory 306 and the undercut walls 329 and the niche 355 of the non-sterile manipulator 310 creates an interlocking configuration that prevents relative movement (e.g., relative longitudinal sliding) between the non-sterile manipulator 310 and the mating surface 307 of the aseptic accessory 306.

[0088] The accessory 306 may have a cut 327 to adjust the elastic properties of the positioning clips of the connector 308 of the sterile accessory 306. The sterile accessory 306 (particularly at least one engagement surface 307) may be made of rubber material to facilitate the surgeon's gripping of its fingers. Preferably, to mechanically engage the sterile accessory 306 with the non-sterile manipulator 310, the sterile accessory 306 is placed over the outer surface 305 of the sterile drape 303, covering a portion of the non-sterile manipulator 310, and pressure is then applied to the engagement surface 307 of the sterile accessory 306 to press the connector 308 so that at least one positioning clip of the sterile accessory 306 snaps into contact with at least one corresponding undercut wall 329 of the non-sterile manipulator 310. To facilitate this mechanical engagement, at least one invitation wall 356 may be provided on or near the portion of the connector 308 of the sterile accessory 306 that is designed to mechanically engage the sterile drape 303 with the non-sterile manipulator 310. Preferably, to avoid tearing the sterile drape 303, the at least one invitation wall 356 may have a generally hemispherical surface, preferably without any cut edges that could tear the sterile drape 303 upon contact with the outer surface 305 of the sterile drape 303.

[0089] According to one embodiment, the plurality of positioning clips of the at least one connector 308 are adapted for snap-fit ​​engagement with the at least one protrusion 309 of the non-sterile manipulator 310, preferably forming a reversible snap-fit ​​engagement. Preferably, the at least one connector 308 (e.g., comprising a plurality of positioning clips) has an arched concave surface 321 facing the outer surface 305 of the surgical drape 303, adapted to engage with the protrusion 309 of the non-sterile manipulator 310 over the sterile drape 303. For example, the arched concave surface 321 of the at least one connector 308 of the sterile accessory 306 forms a generally “C” profile. The sterile accessory 306 itself may include the arched concave surface 321 to conform to the shape of the protrusion 309 of the non-sterile manipulator 310 so that a portion of the sterile drape 303 is held therebetween.

[0090] The at least one sterile accessory 306 may be in a cone or cap shape surrounding the sterile cover 303.

[0091] The mechanical engagement between the at least one sterile accessory 306 and the non-sterile manipulator 310 across the sterile drape 303 may not be a snap-fit ​​type. According to one embodiment, the connector 308 of the at least one sterile accessory 306 has at least one male component that mechanically engages with at least one corresponding female component of the non-sterile manipulator 310 across the sterile drape 303. According to one embodiment, the at least one sterile accessory 306 and the non-sterile manipulator 310 are mechanically engaged across the sterile drape 303 by a press-fit or interference fit. According to one embodiment, the at least one sterile accessory 306 and the non-sterile manipulator 310 are mechanically engaged across the sterile drape 303 by a threaded or pinned connection.

[0092] According to one embodiment, the at least one sterile accessory 306 includes a second surface 328 or an inner surface 328 facing the outer surface 305 of the surgical drape 303. According to one embodiment, for example, as... Figure 4 As shown, the second surface 328 is opposite the at least one mating surface 307 to the body of the attachment 306. The second surface 328 is preferably concave in shape, thereby forming a recess 353 or cavity 353 for receiving the protrusion 309 or at least a portion of the protrusion, and a portion therebetween for securing (e.g., clamping or embedding) the surgical drape 303.

[0093] According to one embodiment, the at least one mating surface 307 of the at least one sterile accessory 306 is convex. The convexity of at least one convex mating surface 307 can be achieved in a direction transverse to the main longitudinal extension direction of the mating surface 307 to facilitate rolling movement of the sterile main input handle assembly 302 between two or more surgeon fingers of a surgeon's single hand during robotic surgery.

[0094] According to one embodiment, the at least one attachment 306 has a generally elongated shape that adapts to the protrusion 309 in the longitudinal direction and is convex in a direction transverse to the longitudinal direction. According to one embodiment, the at least one mating surface 307 of the at least one attachment 306 has a raised shape, thereby exposing a generally crown-shaped surface to the surgeon's finger.

[0095] According to one embodiment, the at least one protrusion 309 of the non-sterile manipulator includes at least one convex surface 313 such that the arched concave surface 321 of the attachment 306 substantially coincides with the convex surface 313, thereby sandwiching a layer of sterile drape 303 between them. According to one embodiment, the body of the sterile drape 303 is located between the arched concave surface 321 of the connector 308 of the attachment 306 and the convex surface 313 of the protrusion 309 of the non-sterile manipulator 310, preferably in contact with both the arched surface and the convex surface.

[0096] According to a preferred embodiment, the sterile main input handle assembly 302 includes an additional or second sterile attachment 306 to have at least two sterile attachments 306 (i.e., a first sterile attachment and a second sterile attachment), wherein the at least two sterile attachments 306 cooperate with the non-sterile manipulator 310 to provide two or more opposing engagement surfaces 307 to allow the surgeon's fingers to grasp and firmly hold the non-sterile manipulator across the sterile surgical drape 303 when the surgeon is using one hand. Preferably, the opposing engagement surfaces 307 are located on opposite sides of the non-sterile manipulator 310, such that they are opposite each other with respect to the body of the non-sterile manipulator 310. Therefore, when the at least two opposing sterile attachments 306 cover at least two opposing portions of the non-sterile manipulator 310 having a gripping controller or cooperating to form a gripping controller, and the gripping controller is designed to control the paired gripping degrees of freedom of the robot-driven surgical instrument 337 operably connected to the sterile main input handle assembly 302, the actuation of the gripping degrees of freedom of the robot-driven surgical instrument 337 is more intuitive for the surgeon.

[0097] According to one embodiment, the sterile drape 303 includes at least one pocket 312, 312' that accommodates at least a portion of the non-sterile manipulator 310 of the sterile main input handle assembly 302. The at least one pocket 312, 312' is at least a portion of the cavity 322, which is defined by at least one sleeve 323, 323' of the surgical drape 303 and has a closed end 352.

[0098] According to an embodiment that is not necessarily combined with any of the embodiments described above, for example, such as Figure 7 As shown, the sterile drape 303 includes a pair of bags 312, 312', each of which contains at least a portion of a non-sterile manipulator 310. Thus, each of the pair of bags 312 or 312' contains a portion of the non-sterile manipulator 310, and the bags 312 and 312' are in fluid communication with each other. That is, the body of a single surgical drape 303 defines cavities 322 of the two bags 312 and 312', preferably defined by a pair of sleeves 323 and 323', each sleeve being connected to a corresponding closed end 352. A drape junction 351 may be formed in or near the opening 357 of each bag 312, 312' within the surgical drape 303.

[0099] According to another embodiment, for example, such as Figure 8As shown, the sterile drape 303 includes two bags 312 and 312', which are made into separate components such that the sterile drape 303 includes multiple drape portions, each of the bags 312 and 312' being defined by sleeves 323, 323' having closed ends 352 and opposing bag openings 357 that can coincide with the drape openings 331 of the corresponding individual drape portions.

[0100] According to one embodiment, the at least one sterile attachment 306 is cheek-shaped, extending beyond the sterile drape 303 and at least partially surrounding at least one protrusion 309 of the non-sterile manipulator 310, to allow for safer manipulation of the non-sterile manipulator 310 when covered by the surgical drape 303. According to one embodiment, the at least one cheek-shaped sterile attachment 306 defines a recess 353 facing and preferably contacting the outer surface 305 of the sterile drape 303, the recess 353 being designed to receive a portion of the non-sterile manipulator 310.

[0101] According to one embodiment, the sterile main input handle assembly 302 includes at least one degree of freedom between the two opposing engagement surfaces 307 and 307'. This at least one degree of freedom may be designed to control a pair of gripping degrees of freedom GSL, GSL' from surgical instruments 337, 337', and a gripping degree of freedom GM, GM'. To activate the gripping degree of freedom, the two opposing engagement surfaces 307 and 307' can be moved, for example, by a pressing action applied by a surgeon's finger 318 towards each other. The degree of freedom between the two opposing engagement surfaces 307 and 307' may be defined by a non-sterile manipulator 310, which, for example, includes two movable portions 316, 316' relative to each other, such as two hinged portions and / or buttons and / or two portions that slide together.

[0102] According to one embodiment, the degree of freedom between the two opposing mating surfaces 307, 307' is defined by at least one attachment 306 itself, for example, as Figure 14 As shown, the area is defined by a deformable bridging member 345 between two opposing mating surfaces 307, 307' of attachment 306. The degree of freedom between the two opposing mating surfaces can be an elastically loaded degree of freedom. For example, the deformable bridging member 345 between the two opposing mating surfaces is an elastically deformable bridging member, which may include or be made of a leaf spring, for example.

[0103] According to one embodiment, the elastic action of the spring-compression degree of freedom causes the two opposing mating surfaces 307 and 307' to deviate from each other.

[0104] For example, such as Figure 13 As shown, in at least one configuration, the two opposing engagement surfaces 307 and 307' together define a convex cylindrical geometry. For example, when the sterile master input handle assembly 302 is in a closed configuration, which can be achieved by moving the two hinged portions of the non-sterile manipulator 310 toward each other, these two opposing engagement surfaces together define a convex cylindrical geometry. This convex cylindrical geometry facilitates the rolling of the sterile master input handle assembly between two or more fingers 318 of the surgeon's hand 319. The two opposing sterile attachments can be integral; that is, the two sterile attachments can be individual units.

[0105] According to a preferred embodiment, the non-sterile manipulator 310 includes at least a pair of elongated elements 316 and 316' hinged to each other to form a tool joint 317 (e.g., a pin joint). Preferably, the elongated elements 316 and 316' are rigid bodies. According to a preferred embodiment, the term "rigid body" means that such a body lacks or has no flexibility. According to an embodiment, the term "rigid body" means that such a body cannot provide elastic bending deformation in an operational state. According to an embodiment, the sterile cover 303 is made of a material that allows relative movement between the elongated elements 316, 316' of the non-sterile manipulator 310. Thus, the sterile cover 303 is flexible or at least partially flexible, allowing spatial movement of the non-sterile manipulator 310 and allowing movement of each and all degrees of freedom in the manipulator (e.g., the gripping degree of freedom of the manipulator).

[0106] Therefore, since the sterile cover 303 includes a pair of bags 312, 312' that are integral or in multiple parts, the elongated elements 316, 316' of the pair of elongated elements 316 or 316' can be respectively accommodated in the corresponding bags 312 or 312'.

[0107] According to one embodiment, the sterile cover 303 includes a bifurcation from which the pair of bags 312 and 312' extend distally.

[0108] According to one embodiment, at least one of the elongated elements 316 and 316' of the non-sterile manipulator 310, and preferably each of the elongated elements 316 and 316', includes at least one protrusion 309. Thus, the at least one protrusion 309 is part of at least one elongated element 316, 316' of the non-sterile manipulator 310.

[0109] According to one embodiment, the at least one elongated element 316, 316', and preferably each of the elongated elements 316 and 316', includes a groove 324, which is preferably disposed along at least one protrusion 309 of the at least one elongated element. The groove is designed to accommodate at least a portion of the flexible body of the surgical drape 303 when the sterile attachment 306 is mechanically engaged with a portion of the non-sterile manipulator 310. For example, folds or other features of the surgical drape 303 may find space within the groove 324 of the non-sterile manipulator 310 to facilitate mechanical engagement of the sterile attachment 306 with the non-sterile manipulator 310.

[0110] According to one embodiment, the at least one elongated element 316, 316', and preferably each of the elongated elements 316 and 316', defines a sensor slot 325 for receiving at least a portion (preferably in a removable manner) of a sensor. The slot 325 may include an adjacent reference surface for the sensor to receive it at a predetermined precise position and / or orientation with respect to the body of the elongated elements 316, 316'. For example, the sensor is a tracking sensor suitable for cooperating with a tracking field generator 339 disposed within a sterile surgical area 311 (e.g., near or at the main control console 350).

[0111] The main console 350 may include at least one tracking field generator, which may be integrated with the surgeon, for example, located on a wearable item (such as a belt or bracelet) to be worn by the surgeon; or the at least one tracking field generator may be mounted on an operating chair; or the at least one tracking field generator may be mounted on the main console 350. The main console 350 may include a tower for the surgeon to stand on in the vicinity of the main console 350, and the tracking system 339 may be integrated with the tower of the main console 350.

[0112] According to one embodiment, the recess 324 of the non-sterile manipulator 310 is also adapted to accommodate a cable connected to the sensor when the sensor is accommodated within the slot 325. A cover 326 or cap 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, the size and shape of which are adapted to receive the sensor slot 325 with or without the cap 326, and the sensor slot seat may communicate with the recess 353 and / or a portion of the recess 353. The portion of the sterile accessory 306 covering the elongated elements 316, 316' of the non-sterile manipulator 310 within the sensor slot 325 may be without connectors so as not to interfere with sensor detection by the sensor accommodated in the sensor slot 325. Preferably, the sensor is a magnetic tracking sensor (i.e., a magnetometer) that cooperates with the tracking field generator.

[0113] According to one embodiment, the tracking system 339 is an optical tracking system that includes at least one camera, such as a set of stereo vision cameras, and the sterile main input handle assembly 302 includes at least one optical marker for optical tracking by the tracked system. The one or more slots 325 and / or the recesses 324 can be used as optical markers.

[0114] According to one embodiment, the at least one accessory 306 is disposable, that is, the at least one accessory is designed for single use in a sterile environment.

[0115] According to one embodiment, the at least one accessory 306 is designed to be sterilized so that it can be reused multiple times during surgery.

[0116] Because of the inclusion of this attachment 306, which forms an enhanced friction surface 307 to create a surface for the surgeon's fingers to manipulate the non-sterile manipulator 310, the need for post-operative handling of the non-sterile manipulator 310 is eliminated. Therefore, the non-sterile manipulator 310 is kept sterile by covering it with a sterile drape 303. Furthermore, the attachment 306 provides the surgeon with a firm and precise grip on the covered non-sterile manipulator 310.

[0117] Because of the presence of at least one engagement surface 307, the surgeon can alternate between manual microsurgery and robot-assisted microsurgery during a single intervention without compromising the sterility of the sterile surgical area 311. This eliminates the need for the surgeon to handle the non-sterile manipulator 310 each time they switch from manual microsurgery to robot-assisted surgery and vice versa during a single intervention.

[0118] According to a general embodiment, a master controller assembly 301 for robotic surgery is provided, the master controller assembly including at least one sterile master input handle assembly 302 according to any of the embodiments described above, and a master console 350. The master controller assembly 301 is designed to control a slave robot assembly 330.

[0119] The main controller component 301 can be placed remotely, and the main console 350 can be placed remotely.

[0120] The main controller assembly 301 can be covered and located within the sterile surgical area 311, and in this part, the main console 350 of the main controller assembly 301 can be covered by a console cover 349.

[0121] According to one embodiment, the main controller assembly 301 includes a tracking system 339, which may be part of the main console 350. The tracking system is, for example, an optical and / or magnetic tracking system adapted to track the position and / or orientation of at least a portion of the sterile main input handle assembly 302 within a predetermined tracking volume, and / or the position and / or orientation of the non-sterile manipulator 310 within the predetermined tracking volume.

[0122] The main input handle assembly 302 may be mechanically ungrounded and mechanically unrestrained with respect to the tracking system 339 and / or the main console 350, and is designed to be held by a surgeon.

[0123] According to one embodiment, a pair of mechanically ungrounded and mechanically unrestrained sterile master input handle assemblies 302 are provided, each of which is designed to be held by a surgeon with one hand, such that the surgeon holds both master input handles 302 in one hand during robotic surgery. These two mechanically ungrounded and mechanically unrestrained sterile master input handle assemblies 302 can control (e.g., individually control) two paired slave surgical instruments 337 of the robotic surgical system 300.

[0124] According to a general embodiment, a robotic surgical system 300 suitable for microsurgery is provided, the robotic surgical system including at least one sterile main input handle assembly 302 according to any of the above embodiments.

[0125] Preferably, the robotic surgical system 300 includes at least one main console 350.

[0126] According to a preferred embodiment, the robotic surgical system 300 further includes a slave robot assembly 330. According to one embodiment, the slave robot assembly 330 includes at least one surgical arm 334 for manipulating the surgical instrument 337. According to one embodiment, the slave robot assembly 330 includes at least one micromanipulator 335 for manipulating the surgical instrument 337. Preferably, the at least one micromanipulator 335 is directly connected in series with the surgical arm 334 to form a kinematic chain with the surgical arm 334, and the at least one micromanipulator manipulates the surgical instrument 337. According to one embodiment, at least two micromanipulators 335 are directly connected in series with the surgical arm 334 to form a kinematic chain with at least two branches with the surgical arm 334. According to one embodiment, the robotic surgical system 300 includes at least one robotic trolley 336, and the at least one surgical arm 334 extends from the robotic trolley 336.

[0127] According to one embodiment, the robotic surgical system 300 includes a control unit, and a tracking system 339 may be part of the control unit. The control unit is adapted to receive at least the position and orientation associated with the non-sterile manipulator 310 and to send command signals to the slave robot assembly 330 to drive the surgical instrument 337. According to one embodiment, the control unit is adapted to receive a first command signal containing information about the hand control command and to send a second command signal containing information about the hand control command to the slave robot assembly 330 to drive the surgical instrument 337.

[0128] The control unit is preferably located in the main control console 350.

[0129] According to one embodiment, the robotic surgical system 300 (preferably the main control console 350 of the robotic surgical system 300) further includes at least one tracking system 339, which includes a field generator. The at least one tracking system is adapted to detect the position and orientation of the non-sterile manipulator 310 within a predetermined tracking volume, preferably by detecting at least the position of a sensor housed in the slot 325 and / or the position of the slot 325.

[0130] According to one embodiment, the at least one tracking system 339 generates the predetermined tracking volume, for example, via a field generator (e.g., a magnetic field generator and / or an optical camera array). For example, the magnetic field generator is arranged to be integrated with the surgeon.

[0131] At least one cover 338 can be set to cover at least a portion of the robot from component 330.

[0132] Preferably, the non-sterile manipulator 310 and / or the sterile master input handle 302 control the robotic surgical system 300 to at least activate the gripping degree of freedom of the articulated end effector located at or near the distal end of the axis of the surgical instrument 337.

[0133] Preferably, the sterile master input handle 302 also controls the positioning of the robotic assembly 330 by controlling the at least one micromanipulator 335, such as a Carthaginian manipulator with three orthogonal linear degrees of freedom. The micromanipulator 335 is preferably located upstream of the axis of the surgical instrument 337. An articulated end effector located at or near the distal end of the axis of the surgical instrument 337 may also include pitch and yaw degrees of freedom, which can be controlled by the sterile master input handle assembly 302. The articulated end effector of the surgical instrument 337 preferably includes pitch, yaw, and gripping degrees of freedom, and the surgical instrument 337 may also include a rolling degree of freedom about its axis.

[0134] According to one embodiment, the robotic surgical system 300 further includes at least one surgical microscope 342. A microscope cover 343 may be provided to cover at least a portion of the microscope 342.

[0135] According to a general embodiment, a sterile surgical area 311 is provided, the sterile surgical area including at least one sterile main input handle assembly 302 according to any of the embodiments described above.

[0136] According to one embodiment, the sterile surgical area 311 further includes at least a portion of the robotic manipulation assembly 330 according to any of the above embodiments. Therefore, the sterile surgical area 311 also includes at least a portion of the robotic surgical system 300 according to any of the above embodiments.

[0137] According to one embodiment, the sterile surgical area 311 further includes at least one operating bed 341, which provides support for the tissue structures of the patient to be treated.

[0138] According to a general embodiment, a surgical drape 303 is provided for a main input handle assembly 302. The drape includes a pair of integrally formed pockets 312 and 312' for respectively accommodating a pair of elongated elements 316, 316' of a non-sterile manipulator 310. The surgical drape 303 may be associated with one or more sterile accessories 306 according to any of the embodiments described above. The non-sterile manipulator 310 of the surgical drape 303 may be any of the non-sterile manipulators 310 described above.

[0139] Because of the features described above, either individually or in combination, in a particular embodiment, the aforementioned needs that provide the above advantages can be responded to, in particular:

[0140] - Easier to control robotic surgical systems from sterile environments (such as sterile surgical areas);

[0141] - A sterile master controller is provided, which includes a non-sterile manipulator adapted to receive hand commands from a surgeon over and through a diaphragm, the sterile master controller having at least one attachment that allows the non-sterile manipulator 310 to be confidently grasped by the surgeon over a sterile barrier.

[0142] - It avoids contamination of the non-sterile manipulator 310, which may include the most expensive features such as sensors, reference surfaces, optical markers and rotary joints, and therefore the non-sterile manipulator can be used for multiple surgeries;

[0143] - Because of the assembly having a drape 303 covering the non-sterile manipulator 310, it is possible to place the sterile master handle assembly 302 and thus the surgeon within the sterile surgical area 311 (e.g., near the operating table 341).

[0144] - This allows surgeons to alternate between manual and robot-assisted microsurgery during a single intervention without needing to sterilize the main controller for this purpose;

[0145] - The covered, unrestricted, non-sterile manipulator can move freely as a whole around the operating table within the main working volume, thus avoiding contamination of the non-sterile manipulator;

[0146] - This sterile accessory provides a solution that can cover non-sterile manipulators to maintain sterility, while simultaneously making the non-sterile manipulators easier to manipulate when covered by surgical drapes;

[0147] - Meanwhile, due to the connector 308 of the accessory 306, the sterile drape 303 is more easily placed around the non-sterile manipulator 310;

[0148] - Since the main input tool can be covered, even when manipulating a non-sterile manipulator in a sterile operating area, there is no need to consider making the non-sterile manipulator disposable, and the surgeon does not need to loosen the grip for this purpose.

[0149] - The sterile drape 303 may have an air-covering body instead of a loose body of the non-sterile manipulator 310, thus allowing a portion of the sterile drape 303 to be constrained to a portion of the non-sterile manipulator 310 due to the presence of the at least one connector 308, preferably to a portion of the non-sterile manipulator at or near at least one protrusion 309.

[0150] Therefore, the connector 308 simultaneously and locally fits the body of the sterile drape 303 against the non-sterile manipulator 310, and holds the mating surface 307 in place.

[0151] To meet possible and specific needs, those skilled in the art can make many modifications, adjustments, and substitutions of the above embodiments with other functionally equivalent elements without departing from the scope of the appended claims.

[0152] List of reference numerals

[0153]

Claims

1. A sterile main input handle assembly (302), comprising: - Non-sterile manipulator (310); - A sterile surgical drape (303) that covers the non-sterile manipulator (310). - The sterile master input handle assembly (302) is mechanically ungrounded and includes features 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 predetermined working volume (320), thereby controlling at least one pair of surgical instruments (337). Its features are, - The sterile main input handle assembly (302) further includes at least one sterile accessory (306) adapted to form a sterile engagement of the sterile main input handle assembly (302) for a surgeon's finger; - The at least one sterile accessory (306) passes over the sterile surgical drape (303) and mechanically engages with the non-sterile manipulator (310); - 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 engagement surface (307) forming the sterile joint, so that the surgeon's fingers can pass over the sterile surgical drape (303) to manipulate the non-sterile manipulator (310). - The at least one sterile accessory (306) forms a sterile handle; - The sterile main input handle assembly (302) includes an additional second sterile attachment so as to have at least two sterile attachments (306), the sterile attachments and the additional second sterile attachments providing two opposing engagement surfaces (307, 307') so that the surgeon's fingers can reach over the sterile surgical drape (303) to grasp the non-sterile manipulator (310). - The sterile main input handle assembly (302) includes the degree of freedom between the two opposing mating surfaces (307, 307').

2. The aseptic main input handle assembly (302) according to claim 1, wherein, The mating surface (307) is a friction surface with a predetermined surface roughness, which is greater than the surface roughness of the outer surface (305) of the sterile surgical drape (303).

3. The sterile main input handle assembly (302) according to any one of the preceding claims, wherein, The mating surface (307) is convex.

4. The sterile main input handle assembly (302) according to claim 1 or 2, wherein, The two sterile accessories (306) are disposed on opposite sides of the non-sterile manipulator (310).

5. The sterile main input handle assembly (302) according to claim 1 or 2, wherein, The degrees of freedom mentioned are elastic compression degrees of freedom.

6. The sterile main input handle assembly (302) according to claim 1 or 2, wherein, In at least one configuration, the two opposing mating surfaces (307, 307') together define a convex cylindrical geometry.

7. The sterile main input handle assembly (302) according to claim 1 or 2, wherein, The two sterile accessories (306) are integrated.

8. The sterile main input handle assembly (302) according to claim 1, wherein, The non-sterile manipulator (310) includes at least a pair of elongated elements (316, 316') that are hinged to each other to form a tool connector (317); wherein at least one of the elongated elements (316, 316') includes at least one protrusion (309); and wherein at least one sterile attachment (306) engages with the protrusion (309).

9. The sterile main input handle assembly (302) according to claim 8, wherein, Each of the elongated elements (316, 316') includes the protrusion (309), and each of the sterile attachments (306) engages with the protrusion (309) of each of the elongated elements.

10. The sterile main input handle assembly (302) according to claim 8 or 9, wherein, The sterile surgical drape (303) includes a pair of bags (312, 312') for accommodating at least one pair of the elongated elements (316, 316'), respectively.

11. The sterile main input handle assembly (302) according to claim 10, wherein, The sterile surgical drape (303) includes a bifurcation, from which the pair of bags (312, 312') extend distally.

12. The sterile main input handle assembly (302) according to claim 1 or 2, wherein, The at least one engagement surface (307) includes a protrusion (354) and / or a valley (354') to accommodate the surgeon's finger.

13. The sterile main input handle assembly (302) according to claim 1 or 2, wherein, The at least one sterile accessory (306) passes over the sterile surgical drape (303) and engages with the non-sterile manipulator (310).

14. The sterile main input handle assembly (302) according to claim 1 or 2, wherein, The at least one sterile accessory (306) is mechanically engaged with the non-sterile manipulator (310) in a detachable manner over the sterile surgical drape (303).

15. The sterile main input handle assembly (302) according to claim 1 or 2, wherein, The at least one sterile accessory (306) is integrated with the sterile surgical drape (303).

16. The sterile main input handle assembly (302) according to claim 15, wherein, The at least one sterile accessory (306) is welded or bonded to the sterile surgical drape (303).

17. A robotic surgical system (300), comprising: - At least one sterile master input handle assembly (302) according to any one of claims 1 to 16. - At least one robotic component (330), said at least one robotic component including at least one surgical instrument (337).

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