Method for controlling the movement of a robotic surgical instrument in and out of the field of view of a viewing system and related surgical robotic system

Abstract

A method for controlling a slave device of a medical or surgical teleoperated robotic system is described. The robotic system to which the method is applied comprises at least one master device 110 adapted to be moved by an operator 150, comprises at least one slave device comprising a surgical instrument 170 adapted to be controlled by the master device, and further comprises observation means configured to display to the operator 150 images and / or videos of an observation space related to a remote operation area in which the surgical instrument 170 operates. The method includes the steps of first defining a safety volume VS contained in the slave workspace but outside the observation space, according to the criterion that a safe level of movement of the surgical instrument 170 is ensured in the safety volume VS to limit or eliminate the risk of contact between the surgical instrument 170 and an anatomical part of the patient or an element supporting the surgical procedure. Next, the method includes determining the position of the surgical instrument 170 to determine whether the surgical instrument 170 is inside the observation space, outside the observation space but inside the safety volume VS, or outside the safety volume VS. The method then includes controlling movement of the slave device in a manner dependent on the determined position of the surgical instrument 170 such that movement of the surgical instrument 170 is permitted in the restricted operating mode even when the surgical instrument 170 is outside the observation space but inside the safety volume VS. Further described is a medical or surgical teleoperated robotic system adapted to be controlled by the aforementioned control method.

Description

[Technical Field]

[0001] The present invention relates to a method and system for controlling a robotic system for medical or surgical teleoperation.

[0002] In particular, the present invention relates to a control method and associated robotic system for the movement of a robotic surgical instrument in and out of the field of view of a viewing system. [Background technology]

[0003] In a system for robotic surgery, the field of view (FOV) provided by any associated observation system (endoscope, laparoscope, microscope, or exoscope) is typically contained within the workspace of the slave device (also defined as the "slave workspace").

[0004] That is, due to high magnification, camera position very close to the workspace, small workspace, or simply large workspace of the slave device, the FOV often represents a subspace, or in other words a subset, of the workspace of the slave device's joints.

[0005] Thus, the movements of the instrument controlled by the master device can be mapped inside the slave workspace (in other words, within the space of the slave joints), but outside the actual field of view FOV and therefore are not performed under the full control of the operator, who in a robotic teleoperation system closes the control loop of each movement through his own field of view mediated by the observation system.

[0006] For example, surgical gestures such as pulling a suture filament or tying a knot during the passage of a needle through tissue, retracting an organ or tissue, or grasping an object at the edge of the FOV can perform actions of the robotic device (or "end effector") outside the FOV.

[0007] For convenience and speed, it is possible, and sometimes frequent, to move instruments out of the field of view instead of continually changing the operating field by zooming down or shifting the viewpoint of the scene to always frame the surgical instruments.

[0008] However, if not performed with care and experience, moving instruments outside of the field of view can be dangerous and can perforate, lacerate, or otherwise damage the patient's tissue, as robotic instruments are typically much harder, stronger, and sharper than tissue can withstand.

[0009] In this situation, an operator attempting to move an instrument "blindly" (when it is no longer in the field of view) during teleoperation and then return to the FOV with the instrument, or attempting to enter teleoperation with an alignment phase that involves movement of an articulated instrument outside the field of view, significantly increases the risk of injury to the patient and poses additional risks.

[0010] A method is known from US 2022 000579 which involves autonomously moving an endoscope backwards in a robotic system when an instrument moves out of the field of view to bring the instrument back into the FOV and widen the field of view. In particular, the instrument is kept in the field of view by autonomously rotating (rolling) a laparoscopic camera having an FOV tilted by an angle (e.g., 30° or 45°) from the top of the endoscope, e.g., a full rotation to achieve a panoramic view of the surgical site.

[0011] This solution is prone to several drawbacks, such as, for example, discomfort due to frequent movements (position and / or orientation) of the observation system to follow the surgical instruments, delays in updating the panoramic image, and / or corresponding frequent changes visible on the screen as a result of camera repositioning that may confuse the operator during surgery.

[0012] From US 2018 0025666 it is known to control and move a camera during an interrupted remote control state, for example using a master controller.

[0013] The known solutions in the considered technical fields do not satisfactorily solve the problems and drawbacks mentioned above.

[0014] Therefore, there is a strong need in the considered technical field to allow and control enslaved movements of a slave device outside the FOV, dependent on a master device, based on an advantageous control algorithm that overcomes or at least mitigates the aforementioned problems and drawbacks. Summary of the Invention

[0015] The object of the present invention is to provide a method for controlling a slave device of a robotic system for medical or surgical teleoperation, in particular a method for controlling the movement of a robotic surgical instrument in and out of the field of view of a viewing system, which at least partially avoids the drawbacks cited above with reference to the prior art and meets the aforementioned needs particularly felt in the considered technical field. Such an object is achieved by a method according to claim 1.

[0016] Further embodiments of such a method are defined in claims 2-36.

[0017] It is also an object of the present invention to provide a medical robotic system or surgical teleoperation adapted to be controlled by or for carrying out the above-mentioned method. Such an object is achieved by a system according to claim 37.

[0018] Further embodiments of such a system are defined in claims 38 to 72.

[0019] Further characteristics and advantages of the method according to the invention will become apparent from the following description of preferred embodiments, given by way of non-limiting indication, with reference to the attached drawings, in which: [Brief explanation of the drawings]

[0020] [Figure 1] 1 illustrates an embodiment of a medical robotic system or surgical teleoperation in accordance with the present invention. [Figure 2] 1 illustrates an embodiment of a medical robotic system or surgical teleoperation in accordance with the present invention. [Figure 3] 1 is a simplified block diagram of a robotic system of the present invention, according to an embodiment; [Figure 3bis] 1 is a simplified block diagram of a robotic system of the present invention, according to an embodiment; [Figure 3ter] 1 is a simplified block diagram of a robotic system of the present invention, according to an embodiment; [Figure 4] 1 illustrates the operation of a prior art slave device, where when a motion outside the field of view (FOV) but inside the slave workspace is commanded, the slave device moves until it reaches a position inside the FOV that is closest to the commanded motion. [Figure 5] Shown are the slave workspace (gray), the field of view FOV (white), the manipulation sub-volume defined by thresholds along the primary axis Z (vertical in the figure) and the transverse axis X (horizontal in the figure), and the cartesian manipulators XYZ. [Figure 5bis] Figure 5 shows the screen of the robot system where the operational sub-volume is displayed. [Figure 6] 1 shows the safety volume defined by different embodiments of the method according to the invention; [Figure 7] 1 shows the safety volume defined by different embodiments of the method according to the invention; [Figure 8] 1 shows the safety volume defined by different embodiments of the method according to the invention; [Figure 9] 1 shows the safety volume defined by different embodiments of the method according to the invention; [Figure 10] 1 shows the safety volume defined by different embodiments of the method according to the invention; [Figure 11] 1 shows the safety volume defined by different embodiments of the method according to the invention; [Figure 12]1 shows the safety volume defined by different embodiments of the method according to the invention; [Figure 13] 1 shows the safety volume defined by different embodiments of the method according to the invention; [Figure 14] 1 illustrates a method for controlling a surgical instrument provided in one embodiment of a method according to the present invention, in which the surgical instrument exits the field of view to a maximum distance point and then returns in a return motion constrained to the indicated bounded area. [Figure 15] 1 shows a display on the screen of a robotic system showing the exit point of a surgical instrument from the observation space according to two embodiments of the method. [Figure 15bis] 1 shows a display on the screen of a robotic system showing the exit point of a surgical instrument from the observation space according to two embodiments of the method. [Figure 16] A status diagram of a robotic system according to an embodiment of the method of the present invention. [Figure 17] A further embodiment of the method is shown in a flow chart. DETAILED DESCRIPTION OF THE INVENTION

[0021] A method for controlling a slave device of a robotic system for medical or surgical teleoperation will be described with reference to FIGS.

[0022] The robotic system to which the method is applied comprises at least one master device 110 adapted to be moved by an operator 150, at least one slave device consisting of a surgical instrument 170 adapted to be controlled by the master device, and observation means configured to display to the operator 150 images and / or videos of an observation space related to a remote operation area in which the surgical instrument 170 operates.

[0023] The master device 110 is preferably an "ungrounded" type master device without force feedback for single-sided remote operation. For example, the master device may be an "ungrounded" type master device without force feedback for single-sided remote operation while simultaneously being a master mechanically constrained to the operation console.

[0024] The master device 110 is preferably a type of master device that is not mechanically bound to an operation console.

[0025] The method includes first defining a safety volume VS included in the slave workspace but outside the observation space according to the criteria that the safety volume VS limits the safe level of movement of the surgical instrument 170 or ensures the elimination of the risk of the surgical instrument 170 coming into contact with the patient's anatomical parts or elements supporting the surgical procedure.

[0026] Next, the method includes determining the position of the surgical instrument 170 to establish whether the surgical instrument 170 is inside the observation space, outside the observation space but inside the safety volume VS, or outside the safety volume VS.

[0027] The method then includes controlling movement of the slave device in a manner dependent on the determined position of the surgical instrument 170 such that movement of the surgical instrument 170 is permitted in the restricted operating mode even when the surgical instrument 170 is outside the observation space but inside the safety volume VS.

[0028] According to embodiments of this method, the safety volume VS is defined based on geometric or structural criteria of the slave device or surgical instrument, and / or based on geometric and structural criteria of the robotic system, and / or based on the surgical setup.

[0029] According to an embodiment of this method, a safety volume VS is defined relative to a surgical work surface, which defines the surface on which robotic surgery is performed during teleoperation, or the boundary of the working area of ​​surgical instruments proximate to the patient's anatomy.

[0030] According to an embodiment of this method, the safe volume VS is dynamically defined during teleoperation from the observation space FOV according to the last determined or recorded exit point of the surgical instrument 170 .

[0031] According to an embodiment of this method (eg, as shown in FIG. 6), the safety volume VS has an outer perimeter of the observation space that extends beyond the boundaries of the observation space by a spatial tolerance ε.

[0032] According to some possible implementations of such an embodiment, the spatial tolerance ε is a predefined constant value, or a dynamically variable value defined as a function of the velocity of the surgical instrument 170 when it leaves the observation space, or a dynamically variable value defined as a function of a scale factor between the movement of the master device and the resulting movement of the slave device.

[0033] According to another embodiment of the method, the safety volume VS has a cone or a cone-shaped stem defined around the direction of exit of the surgical instrument from the observation space.

[0034] According to some possible examples of such an embodiment (e.g., as shown in Figures 7 and 8), the cone or cone-shaped stem has a height h and an opening α that is angled around the direction of exit of the surgical instrument from the viewing space.

[0035] Such height and such angled opening depend on the exit speed of the surgical instrument 170 from the observation volume, on the scale factor between the movement of the master device and the resulting movement of the slave device, or on other motion parameters of the robotic system.

[0036] According to an embodiment of this method, the angled opening is either inversely proportional to the exit velocity or directly proportional to the scale factor, and the height is either directly / inversely proportional to the exit velocity or directly / inversely proportional to the scale factor.

[0037] According to another embodiment of the method, the angular opening of the cone relative to the coordinates associated with the viewing space is calculated / estimated as a function of the direction in which the surgical instrument reaches the limits of the viewing space.

[0038] According to an embodiment, the apex angle α of the cone is in the range of 30° to 60° depending on safety and ease of use criteria.

[0039] According to an embodiment, the height h of the cone, in other words the maximum distance that the safety volume is allowed from the observation space, is in the range of 50 mm to 100 mm depending on the scale factor and the observation system.

[0040] According to another embodiment of this method (e.g., shown in Figure 9), the safety volume VS has a cylinder or lumen volume defined along the longitudinal axis of the surgical instrument such that when the surgical instrument is outside the observation space FOV, the surgical instrument can only move along or around its dominant axis.

[0041] According to another embodiment of this method (e.g., shown in FIG. 10), the safety volume VS has a convex polyhedron that depends on the exit point of the surgical instrument 170 from the observation space, defined to exclude portions of space that are at a distance less than the distance of the exit point from the surgical work surface, so as to prevent the surgical instrument from crossing the surgical work surface and / or the original work surface and / or the work surface on which it was previously working.

[0042] According to an example of such an embodiment, movement of the surgical instrument when exiting the observation space and outside thereof is not permitted while approaching the surgical work table in a direction Z perpendicular to the surgical work table XY in order to avoid depressions and penetrations in the patient's tissue.

[0043] According to an embodiment of this method (eg, as shown in FIG. 11), the safety volume VS comprises a volume or half-space consisting of all points far from the surgical table relative to the focal point of the observation system.

[0044] According to an embodiment of this method (e.g., shown in FIG. 12), the safety volume VS has an angled opening calculated or estimated from the leading angle θ of the axis of the surgical instrument 170, and has a cavity-shaped volume with a point far from the surgical table relative to the focal point of the observation system.

[0045] According to embodiments of this method, the safety volume VS may comprise any combination of one or more volumes set forth in the embodiments shown above.

[0046] A further example of the safety volume this method provides is given below.

[0047] Consider the Euclidean distance between the current reference position in the coordinates of the slave device and the last observed point in visual space represented by the same coordinates.

[0048] If such distance is greater than a preset threshold (for example 2 mm, in other words calculated as 20% of the observation space in meters), the teleoperation is interrupted.

[0049] According to another embodiment, instead of the distance between points defined in three-dimensional coordinates, the distance between the slave device and the surface of the observation space remapped to the slave device's space is taken into account, in other words the distance between the slave device and the center of the observation space in the slave device's coordinates. Such an option makes it possible to express distances in terms of the volume itself, rather than the distance traveled.

[0050] According to another embodiment, the distance between the part and the complementary distance to the working surface of the observation space at the exit point is weighted taking into account the relationship between the workspace and the observation space of the slave device, in which case no further descent is possible.

[0051] According to another embodiment (for example shown in Fig. 13), knowledge of prohibited areas ("no-entry areas") within the observation space is taken into account, expressed in the coordinate space of the slave device described according to a containment volume, for example an ellipsoid or a parallelepiped. In these cases, the safety volume excludes said prohibited areas. Approaching such a prohibited area will first trigger an audio, visual and / or haptic warning and, if necessary, an exit from the remote control.

[0052] According to an embodiment of the method, said observation space is defined by the field of view (FOV) of the observation means.

[0053] Such an embodiment refers to a robotic system having an observation means or a general observation system (with digital image / video acquisition means) that can capture the part of the world being observed through an appropriate lens and light guide system.

[0054] Considering the terminology known in the technical field, such part of the world from which an image or video is acquired has an extension called the "field of view" or (FOV), usually expressed in angular units taken along one of the diagonals or axes of the digital image / video acquisition system.

[0055] According to another embodiment of the method, the observation space is defined by a predefined subset of the field of view (FOV) of the observation means.

[0056] According to another embodiment of the method, said observation space is defined by a field of view workspace consisting of a geometric volume in the reference coordinate system of the robot system associated with said field of view.

[0057] Such a field-of-view workspace (hereafter also referred to as "FOV workspace") can correspond to a volume, such as a trapezoid, pointing from the lens to infinity and centered on the optical system's major axis, and can represent the field of view of a digital observation system, for example, for a lens with a field of view (FOV) of less than 180 degrees. When a plane is fixed relative to the lens, it is possible to evaluate the field of view extension in metric terms by evaluating the portion of the plane that intersects the "FOV workspace," and generally such a plane is orthogonal to the major axis. The diagonal of the plane's rectangle at a certain distance can be defined as the "FOV diagonal."

[0058] According to another embodiment of the method, said observation space is defined in the reference coordinate system of the robot system by the geometric limits of the field of view consisting of the bounding surfaces of said field of view workspace.

[0059] For example, the FOV workspace is constructed relative to a trapezoid whose origin is the observation system's camera image plane. It is imposed to limit the slave device's movement and is called the "FOV workspace constraint," from which simplified shapes can be constructed. Such shapes can be defined as planes orthogonal to the observation system, or as curved surfaces, but in either case they are defined inside the FOV workspace.

[0060] According to some possible embodiments, said observation means comprise at least one camera 120 or comprise an endoscope and / or a laparoscope and / or a microscope and / or an exoscope.

[0061] According to an embodiment, the observation means comprises a stereoscopic observation system consisting of two cameras, each defining a respective "FOV workspace" (175L, 175R) called "Field of View workspace of camera L" (FOV workspace L) and "Field of View workspace of camera R" (FOV workspace R). The intersection of the aforementioned two field of view workspaces of camera L and camera R generates a "common field of view workspace" that guarantees maximum visibility of objects in the scene.

[0062] For a given point in such a "common view workspace", the disparity or difference (in given units) in the lateral position of the same element can be calculated: excessive difference leads to a lack of depth perception, resulting in a blurring effect.

[0063] For example, such viewing means may comprise digital viewing means suitable for robotic surgery and / or microsurgery.

[0064] According to an embodiment of this method, controlling the movement of the slave device in a manner dependent on the determined position of the surgical instrument 170 includes permitting movement of the surgical instrument 170 in a normal operating mode when the surgical instrument 170 is within the aforementioned field of view (FOV).

[0065] According to an embodiment of the method, the aforementioned step of defining a safe volume Vs comprises calculating said safe volume Vs by one or more computer vision algorithms operating in real time based on digital data derived from the observation means.

[0066] According to another embodiment of the method, the aforementioned step of defining the safety volume VS comprises calculating said safety volume VS by one or more computer vision algorithms operating on the basis of digital data obtained from a second observation means having a second field of view FOV2 or on digital data / images recorded in a pre-operational stage.

[0067] According to another embodiment of the method, the safety volume is defined as a volume surrounding the observation space, from which sub-volumes or non-penetrating sub-areas in which movement of surgical instruments is not permitted are excluded.

[0068] According to different examples of such an embodiment, the computer vision software algorithm identifies, both on the remotely operated enlarged image FOV1 and on the reduced zoom processed image FOV2, anatomical regions or volumes that will not be penetrated during remote operation, and instrument movements outside the field of view and / or within FOV2 and / or both FOV1 and FOV2 are allowed only if performed in free space without penetrating the identified tissue, and similarly, movements that would cause penetration of previously recorded and identified tissue or region or volume are suppressed only if the field of view parameters are not changed and / or modified between the two detection moments t1 and t2.

[0069] The control unit of the robot system stores the movements and coordinates of the device performed within FOV1 with z1 (or parameters of FOV1) at time t1.

[0070] In a subsequent session performed at a later time t2, the system allows actions outside FOV1 only if such actions repeat, within 1ε, the actions performed at t1 in FOV2, with parameter z2 and FOV2>FOV1.

[0071] In any of the embodiments and / or options above, once the device is permitted to leave FOV1 according to trajectory p1, it is permitted to return to FOV1 only by moving along the same trajectory p1 and / or around p1 and / or around a cone that contains p1.

[0072] Such a choice may be allowed because p1 is deemed safe by some "computer vision" algorithms, or due to the fact that p1 is performed within FOV2 and the observation system remains unchanged except for the zoomed FOV2. This allows the system to still consider repeated movements made by the user outside FOV1 as safe, provided that the trajectory is equivalent to the one made previously when FOV2 was visible.

[0073] Such a trajectory p1 is allowed outside the FOV1 only if it has a trajectory that is mainly straight and does not have a curved trajectory or a trajectory with multiple repeated depressions.

[0074] Such a feature can be provided in an embodiment where the observation system is stationary between instants t1 and t2 and only the zoom is changed, determining FOV1 and FOV2.

[0075] According to an embodiment of the method, the aforementioned step of defining the safety volume VS comprises calculating such safety volume VS based on digital data originating from a second observation means having a second field of view FOV2 or by one or more computer vision algorithms operating on digital data / images recorded in a pre-operational stage.

[0076] According to an embodiment, the safety volume is defined as the volume surrounding the observation space, from which sub-volumes or non-penetrating sub-areas in which the movement of surgical instruments is not permitted are excluded.

[0077] According to another embodiment of the method, the aforementioned step of defining the safe volume VS comprises calculating the safe volume VS as a volumetric extension of the observation space.

[0078] According to another embodiment of the method, the aforementioned step of defining the safe volume V S comprises calculating the safe volume V S based on kinematic or mechanical information of the robot system and / or slave devices.

[0079] According to another embodiment of the method, the aforementioned step of defining a safety volume (VS) includes: - recording an exit point and an exit orientation of the surgical instrument from the observation space based on digital data or an image provided by the observation means, and expressing said exit point and exit orientation in coordinates referenced to the coordinate system of the slave workspace; Calculating or defining said safety volume VS based on the exit point and exit orientation of the surgical instrument from the observation space.

[0080] According to an embodiment of the method, the aforementioned step of determining the position of the surgical instrument 170 includes determining the current position of the surgical instrument 170 and / or the presence of the surgical instrument 170 in the observation space based on digital data derived from the observation means.

[0081] According to another embodiment of the method, the aforementioned steps of determining the position of the surgical instrument 170 include the following. - mapping said observation space into a slave reference coordinate system associated with the slave device in a corresponding slave field of view workspace; - determining the position of the surgical instrument 170 with respect to each position coordinate in said slave reference coordinate system; determining a position of the surgical instrument 170 relative to a tolerance space relative to the observation space based on a comparison of position coordinates in the slave reference coordinate system with the slave viewing workspace;

[0082] According to an example of the aforementioned embodiment, the method further includes the following steps: In the slave reference coordinate system, the slave kinematic workspace 175 is defined based on the physical travel limits of the slave device and / or operational constraints not related to the observation means. - defining in the slave reference coordinate system an actual slave workspace 200 corresponding to the intersection of the aforementioned slave visual workspace and the slave kinematic workspace 175;

[0083] In such a case, the step of controlling the movement of the slave device includes controlling the movement of the slave device such that movement of the surgical instrument 170 is permitted only when the surgical instrument 170 is within said actual slave workspace 200.

[0084] More specifically, for example, a field of view slave workspace (or "FOV slave workspace") can be defined as a workspace that is geometrically equivalent to the field of view slave workspace, but transposed by a mapping function (e.g., a rotational transformation) in the slave device's frame of reference.

[0085] Such an "FOV slave workspace" is intersected with the slave kinematic workspace 175 as it always is, resulting in the actual slave workspace 200 described above, which can be used by various movement constraint algorithms.

[0086] According to an embodiment, the FOV of the slave workspace FOV is contained within 175 of the slave kinematic workspace.

[0087] According to another embodiment, the visual field slave workspace is only partially contained within the slave kinematic workspace 175 .

[0088] According to an embodiment, the actual slave workspace 200 is the intersection of the slave kinematic workspace 175 and the field of view slave workspace.

[0089] According to an embodiment, the actual slave workspace 200 is dwarfed and limited by the field of view slave workspace.

[0090] According to some possible implementations of the method, such a constraint can be made by a pure geometric intersection between two convex shapes, or can be simplified in the trunk of a parallelepiped or pyramid inside such an intersection (and thus calculated by the software to have, for example, an actual workspace 200 with the desired shape / usability).

[0091] According to one embodiment of the method, the aforementioned steps of determining the position of the surgical instrument 170 relative to the observation space are performed periodically and / or continuously in real time to confirm the position or presence of the surgical instrument 170 in the observation space or real-time actual slave workspace 200.

[0092] According to one embodiment of the method, the aforementioned step of determining the position of the surgical instrument 170 relative to the tolerance space relative to the observation space includes calculating and / or determining the positions of real points belonging to the surgical instrument or the positions of virtual points integral with the surgical instrument 170 based on images provided from the observation system.

[0093] According to an embodiment, the aforementioned step of determining the position of the surgical instrument 170 includes determining the position of a virtual control point 600 of the slave device (e.g., located between the tips 171, 172 or "jaws" 171, 172 of the surgical instrument 170).

[0094] According to another embodiment, the aforementioned step of determining the position of the surgical instrument 170 includes determining the position of at least one of the tips 171 , 172 of the surgical instrument 170 .

[0095] According to an embodiment, the aforementioned step of determining the position of the surgical instrument 170 includes determining the position of at least one link of a hinged wrist (or “end effector”) 177 included in the surgical instrument 170.

[0096] According to another embodiment, the aforementioned step of determining the position of the surgical instrument 170 includes determining the position of the positioning shaft 179 or a distal portion of the shaft 179 near the hinged wrist 177 of the surgical instrument 170.

[0097] According to an embodiment of the method, the observation space comprises the aforementioned field of view (FOV) of the observation means, or a predefined subset of the field of view (FOV).

[0098] According to another embodiment, the method further comprises the step of defining limits or edges of the observation space, which limits or edges define upper and lower thresholds of movement allowed for the slave device.

[0099] According to an embodiment, said limit or edge comprises a threshold boundary on a plane XY perpendicular to the depth direction Z of the field of view FOV.

[0100] Such threshold boundaries define upper / lower thresholds for movement within said plane XY and / or along orthogonal axes X, Y belonging to said plane XY. The threshold boundaries are calculated according to the distance of the plane XY relative to the observation means.

[0101] According to another embodiment, the aforementioned limits or edges include threshold boundaries on the plane XY as well as lower / upper thresholds along the depth axis Z of the field of view FOV.

[0102] In such cases, the lower / upper thresholds along the depth direction Z axis are determined based on the good focusing of the observation means, evaluated and calculated in real time using data provided from the observation means, or based on the depth of field of the observation means of a given configuration within a predefined focusing tolerance range provided by the observation means.

[0103] In an embodiment, the limits of the field of view workspace are defined as the trunk of a pyramid defined by Z as a complex function of X, Y, and Z, and are calculated taking into account the intersection workspace of the stereo viewing system.

[0104] According to an embodiment, upper / lower thresholds are defined to avoid entering areas where there is an excessive difference between the two viewpoints, which would result in a blurred view for the operator.

[0105] According to an embodiment of the method, the aforementioned step of controlling the movement of the slave device includes the following steps: -Allowing the surgical instrument 170 to exit the FOV space and / or viewing space limitations of the viewing space and / or field of view - allowing limited movement of the operating mode 170 and maintaining a remotely controlled state when the surgical instrument 170 is outside the observation space and inside the safety volume VS; - If the surgical instrument 170 is outside both the observation space and the safety volume VS, its movement is not permitted. Allowing the surgical instrument 170 to return from the safety volume VS to within the FOV space and / or viewing space limits and remain in a remotely controlled state.

[0106] As mentioned above, in an embodiment, the method provides for entering a special mode (or "limited" mode) when the position of the surgical instrument is moved outside the field of view FOV by command of the master device and until the surgical instrument returns inside the field of view FOV.

[0107] In such cases, the method includes allowing movement outside the FOV if the position outside the FOV is within the defined safety volume VS and / or within an allowed leave / return volume in the space of the slave device characterized by new limits and within which the surgical instrument may move.

[0108] According to method embodiments, the aforementioned step of enabling movement of the surgical instrument 170 in the limited operational mode includes controlling the slave device to move at a limited or reduced speed that is less than the maximum speed achievable and / or allowed when the slave device is within the observation space.

[0109] According to another embodiment of the method, the aforementioned step of enabling movement of the surgical instrument 170 in the restricted mode of operation includes controlling the slave device to move with a scale factor between the master device and the slave device that is increased with respect to the scale factor provided within the observation space.

[0110] According to an embodiment of the method, the aforementioned step of permitting movement of the surgical instrument 170 in the restricted mode of operation includes permitting movement of the surgical instrument only along the edges or limits of the safety volume VS when the surgical instrument reaches the edges or limits of the safety volume VS, or temporarily blocking the surgical instrument once the surgical instrument reaches the edges or limits.

[0111] According to method embodiments, the aforementioned steps of enabling movement of the surgical instrument 170 in a restricted mode of operation include constraining or restraining one or more degrees of freedom of the surgical instrument 170.

[0112] According to an embodiment of the method, the aforementioned steps of allowing the surgical instrument 170 to return from the safety volume VS to the observation space include the following steps. - identifying a phase of exit and / or distancing of the surgical instrument 170 from the observation space in which the distance of the surgical instrument from the edge of the observation space increases, wherein said safe volume VS is the calculated exit safe volume associated with a phase of exit and / or distancing of the surgical instrument 170 from a return phase of the surgical instrument 170 towards the observation space in which the distance of the surgical instrument from the edge of the observation space decreases. - At the beginning and end of the return phase, calculate the return safe dose included in the safety volume, other than the safety volume. - controlling the movement of the surgical instrument 170 during the return phase so that it remains within the return safe volume;

[0113] According to an embodiment, the aforementioned return safety volume comprises a containment volume, such as the trunk of a containment cone or another containment geometric shape (e.g., a "spline tube"), that contains all coordinates traveled by the surgical instrument 170 during the exit and distancing phases.

[0114] In such cases, controlling the movement of the surgical instrument 170 during the return step includes constraining the surgical instrument 170 to remain within the return safety volume by translational or speed limits that ensure the return speed is less than the exit speed.

[0115] According to an embodiment, the method includes keeping the robotic system and slave devices in teleoperation if and when the surgical instrument 170 is within the observation space or safety volume VS.

[0116] According to another embodiment, the method includes stopping teleoperation of the robotic system or exiting teleoperation of the robotic system when and if the surgical instrument 170 exits the safety volume and is outside both the safety volume and the observation space.

[0117] According to another embodiment, the method further comprises the step of permitting and / or enabling alignment operations between the master device 110 and the slave device 170 and / or permitting entry into remote operation even if the surgical instrument 170 is outside the observation space, but only if it is inside the safety volume VS.

[0118] According to another embodiment, the method further comprises the step of permitting and / or enabling alignment operations between the master device 110 and the slave device 170 and / or enabling entry into teleoperation following an exit from the teleoperation phase upon reaching an edge or limit of the safety volume VS.

[0119] According to an embodiment, the method is applied to a robotic system having a plurality of slave devices and respective surgical instruments.

[0120] In such a case, the method steps are performed for the slave device and each surgical instrument.

[0121] According to an embodiment, the method further comprises providing a visual and / or audible and / or tactile alert to the operator when the device approaches a limit or edge of the observation space and / or when the device approaches a limit or edge of the safety volume VS.

[0122] According to an embodiment, the method further comprises providing an actuation means, e.g., a pedal, which when actuated by an operator of the robotic system allows movement of the surgical instrument outside the observation space or safety volume.

[0123] According to an embodiment (e.g., shown in Figures 15 and 15bis), the method further includes providing a visual element on the screen to guide the operator while performing the return of the surgical instrument 170 to the observation space or to inform the operator of the exit of the surgical instrument 170 from the observation space.

[0124] According to an embodiment, a suitable overlay representing the safety volume is used, such a representation being superimposed on the image of the observation system.

[0125] According to another embodiment, indicators are displayed at the edges of the observation space FOV, the position of the indicator indicating the most likely return point, the color of the indicator indicating the distance on a graduated scale, and the shape of the indicator indicating whether it is a return phase or not.

[0126] According to another embodiment, the display will consistently alert the user as they approach distance away from the remote control.

[0127] According to an embodiment, the observation volume FOV is depicted small and a surrounding safety volume area is visually displayed (in other words, a "virtual unzoom" that kicks in after a certain distance).

[0128] In such a case, the observation system's image is appropriately scaled in the center of the screen surrounded by a space of uniform color (e.g., gray) in which a projection of the exiting device is displayed.

[0129] According to the embodiment shown in the flowchart of FIG. 17, after exiting teleoperation outside the observation space FOV and calculating the safe volume, the limited teleoperation phase is entered.

[0130] 1-17, a medical or surgical teleoperated robotic system 100 included in the present invention will now be described.

[0131] Such a robotic system comprises at least one master device 110 adapted to be moved by an operator 150, at least one slave device consisting of a surgical instrument 170 adapted to be controlled by the master device, observation means configured to display to the operator 150 images and / or videos of an observation space related to a teleoperation area in which the surgical instrument 170 operates, and a control unit configured to control the slave device during teleoperation based on movements of the master device.

[0132] The control unit is further configured to: - Defining a safety volume VS included in the slave workspace but outside the observation space, which limits or eliminates the risk of the surgical instrument 170 coming into contact with the patient's anatomy or elements supporting the surgical procedure, according to the criterion that a safe level of movement of the surgical instrument 170 is ensured in the safety volume VS. Determining the position of the surgical instrument 170 to determine whether it is inside the observation space, outside the observation space but inside the safety volume VS, or outside the safety volume VS. Controlling the movement of the slave device in a manner dependent on the determined position of the surgical instrument 170, so that movement of the surgical instrument 170 is permitted in the restricted operating mode even when the surgical instrument 170 is outside the observation space but inside the safety volume VS.

[0133] According to some possible implementations of the robotic system, the control unit is configured to execute a method for controlling a slave device according to any one of the embodiments presented herein.

[0134] Thus, the above-stated objects of the present invention are fully achieved by the method and system disclosed above, in accordance with the features detailed above.

[0135] In particular, instead of continuously changing the field of view by zooming out or moving its viewpoint on the scene, the method allows the robotic system to remain in (or enter) a special state of teleoperation (i.e., a "restricted operational mode") when the surgical instrument(s) are removed outside the field of view (FOV). In such a state, movement of the surgical instrument is permitted even outside the field of view (FOV) as long as it is within a defined safety volume to comply with safety standards while outside the observation space.

[0136] This provides advantages in terms of time spent in use and intuitive operability, while also maintaining sufficient safety.

[0137] The presented method is based on adapted technical solutions to allow the movement of instruments outside the observation space in a way that is safe for the patient and remains practical and intuitive for the operator / surgeon.

[0138] Those skilled in the art may make changes and adaptations to the above-described method and system embodiments, or may substitute other functionally equivalent elements to meet their foreseeable needs, without departing from the scope of the following claims. Each feature described as belonging to a possible embodiment may be implemented independently of the other embodiments described.

Claims

1. 1. A method for controlling a slave device of a medical or surgical telerobotic system, comprising: The robot system includes: at least one master device (110) adapted to be moved by an operator (150); at least one slave device having a surgical instrument (170) adapted to be controlled by said master device to move within a slave workspace of said slave device; a viewing means (120) configured to display to the operator (150) images and / or videos of a viewing space associated with a remote control area in which the surgical instrument (170) is operated; Equipped with The method comprises: - defining a safety volume (VS) included in the slave workspace but outside the observation space, according to the criteria that the risk of contact between the surgical instrument (170) and the patient's anatomical parts or elements supporting the surgical operation is limited or eliminated and that in the safety volume (VS) a safe level of movement of the surgical instrument (170) is ensured; - determining the position of the surgical instrument (170) and determining whether the surgical instrument (170) is inside the observation space, outside the observation space but inside the safety volume (VS), or outside the safety volume (VS); - controlling the movement of the slave device in a manner dependent on the determined position of the surgical instrument (170), such that movement of the surgical instrument (170) is permitted in a restricted operating mode even when the surgical instrument (170) is outside the observation space but inside the safety volume (VS); A method comprising:

2. The safety volume (VS) is based on geometric or structural criteria of the slave device or the surgical instrument, and / or based on the shape and structure of the robotic system, and / or based on the surgical setup; and / or - Regarding operating tables: defined, 10. The method of claim 1, wherein the surgical work surface defines a surface on which robotic surgery is performed during teleoperation, or a boundary of a working area for surgical instruments proximate a patient's anatomy.

3. The safety volume (VS) is the outer perimeter of the observation space beyond its boundaries by a spatial tolerance (ε), and / or a cone or cone-shaped stem defined around the direction of exit of the surgical instrument from the viewing space, and / or - a cylinder or lumen volume defined along the longitudinal axis of the surgical instrument, and / or a convex polyhedron dependent on the exit point of the surgical instrument (170) relative to the observation space, defined so as to exclude parts of the space that are closer to the surgical table than the exit point is to the surgical table, so as not to cross the surgical table and / or the work surface on which the surgical instrument was previously working; and / or a volume or half-space that includes all points further from the operating table than the focal point of the observation system, and / or - a hollow-shaped volume having an angled opening calculated or estimated from the leading angle of the axis of the surgical instrument (170), and including a point further from the surgical table than the focal point of the observation system; 3. The method of claim 2, comprising:

4. 4. The method of claim 2 or 3, wherein the safety volume (VS) is dynamically defined during teleoperation according to a determined or recorded latest exit point of the surgical instrument (170) from the observation space.

5. the safety volume (VS) comprises the outer perimeter of the observation space; 5. The method of claim 3 or 4, wherein the spatial tolerance (ε) is a predefined constant value or a dynamically variable value defined as a function of the velocity of the surgical instrument (170) when exiting the observation space or as a function of a scale factor between the movement of the master device and the resulting movement of the slave device.

6. the safety volume (VS) has a cone or cone-shaped stem with a height and angled opening around the direction of exit of the surgical instrument from the observation space; 5. The method of claim 3 or 4, wherein the height and the angled opening depend on an exit speed of the surgical instrument (170) from the observation space, or on a scale factor between the movement of the master device and the resulting movement of the slave device, or on other motion parameters of the robotic system.

7. the angled opening is inversely proportional to the exit velocity or directly proportional to the scale factor; the height H is directly / inversely proportional to the exit velocity or directly / inversely proportional to the scale factor; 7. The method of claim 6, wherein the angular opening of the cone relative to coordinates associated with the view space is calculated / estimated as a function of the direction in which the surgical instrument reaches the limits of the view space.

8. 5. The method of claim 3 or 4, wherein the safety volume (VS) has a cylinder or lumen volume defined along a longitudinal axis of the surgical instrument so as to only allow movement of the surgical instrument along or about its dominant axis when the surgical instrument is outside the observation space (FOV).

9. the safety volume (VS) comprises the convex polyhedron; 5. The method according to claim 3 or 4, wherein movement of the surgical instrument out of the observation space and movement of the surgical instrument outside the observation space are not permitted in approaching the surgical work table in a direction (Z) perpendicular to the surgical work table (XY).

10. the observation space is defined by a field of view (FOV) of the observation means; 10. The method of claim 1, wherein controlling movement of the slave device in a manner dependent on the determined position of the surgical instrument comprises allowing movement of the surgical instrument in a normal operating mode when the surgical instrument is within the field of view (FOV).

11. 11. The method of claim 1, wherein defining the safety volume (VS) comprises calculating the safety volume (VS) by one or more computer vision algorithms operating in real time based on digital data derived from the observation means.

12. 11. The method of claim 2, wherein defining the safety volume (VS) comprises calculating the safety volume (VS) based on digital data derived from a second observation means having a second field of view (FOV2) or by one or more computer vision algorithms operating on digital data / images recorded in a pre-operational stage.

13. 10. The method of claim 2, wherein the safety volume is defined as a volume surrounding the observation space, excluding sub-volumes or non-penetrating sub-regions in which movement of the surgical instrument is not permitted.

14. 10. The method of claim 2, wherein defining the safety volume (VS) comprises calculating the safety volume (VS) as a volumetric extension of the observation space and / or based on kinematic or mechanical information of the robot system and / or the slave device.

15. Defining the safety volume (VS) - recording an exit point and an exit orientation of said surgical instrument from said observation space based on digital data or images provided by said observation means, and expressing said exit point and said exit orientation in coordinates referenced to the coordinate system of said slave workspace; Calculating or defining the safety volume (VS) based on the exit point and the exit orientation of the surgical instrument from the observation space.

16. 16. The method of any one of claims 1 to 15, wherein determining the position of the surgical instrument (170) comprises determining the current position of the surgical instrument (170) and / or the presence of the surgical instrument (170) in the observation space based on digital data derived from the observation means.

17. Determining the position of the surgical instrument (170) comprises: - mapping said observation space into a slave viewing workspace corresponding to a slave reference coordinate system associated with said slave device; - determining the position of said surgical instrument (170) in respective position coordinates in said slave reference coordinate system; - determining, in the slave reference coordinate system, a position of the surgical instrument (170) relative to the observation space based on a comparison of the position coordinates with the slave field of view workspace.

18. - Defining a slave kinematic workspace (175) in a slave reference frame (SFO) based on physical movement limits of the slave device and / or motion constraints that are not correlated to the observation means; - defining in said slave reference coordinate system an actual slave workspace (200) corresponding to the intersection of said slave field of view (FOV) workspace and said slave kinematic workspace (175), 18. The method of claim 17, wherein controlling the movement of the slave device comprises controlling the movement of the slave device such that movement of the surgical instrument (170) is permitted when the surgical instrument (170) is inside the actual slave workspace (200).

19. 19. The method of any one of claims 16 to 18, wherein determining the position of the surgical instrument (170) is performed periodically and / or continuously to ascertain the position or presence of the surgical instrument (170) in the observation space or the actual slave workspace (200) in real time.

20. Determining the position of the surgical instrument (170) comprises: - calculating and / or determining the positions of real points belonging to said surgical instrument or the positions of virtual points integral with said surgical instrument (170), and / or - calculating and / or determining the position of the virtual control point (600) of said slave device, and / or - determining the position of at least one of the tips (171, 172) of said surgical instrument (170), and / or - determining the position of at least one of the links of a hinged wrist (177) included in said surgical instrument (170), and / or The method according to any one of claims 16 to 18, comprising determining the position of a distal portion of a positioning shaft (179) proximal to the hinged wrist (177) of the surgical instrument (170).

21. the observation space comprises the field of view (FOV) of the observation means, or a predefined subset of the field of view (FOV), or a workspace of the field of view (FOV), or the actual slave workspace (200); further comprising defining limits or edges of the observation space; 20. The method of claim 10 or 18, wherein the limits or edges define upper and lower thresholds for allowed movement of the slave device.

22. the limit or edge has a threshold boundary in a plane (XY) perpendicular to the depth direction (Z) of the field of view (FOV); said threshold boundaries define upper / lower thresholds for movement within said plane (XY) and / or along orthogonal axes (X, Y) belonging to said plane (XY); 22. The method of claim 21, wherein the threshold boundary is calculated as a function of the distance of a plane (XY) relative to the observation means.

23. the limits or edges have lower / upper thresholds along the depth (Z) axis of the field of view (FOV) in addition to the threshold boundaries in a plane (XY); 23. The method of claim 22, wherein the lower / upper thresholds along the depth (Z) axis are determined based on good focus of the observation means assessed and calculated in real time using data provided by the observation means, or based on the depth of field of the observation means in a given configuration.

24. Controlling the movement of the slave device - allowing the surgical instrument (170) to exit from the space of the observation space and / or field of view (FOV) and / or the limitations of the observation space; - when the surgical instrument (170) is outside the observation space but inside the safety volume (VS), maintaining a remote control state and allowing movement of the surgical instrument (170) in a limited operating mode; - not allowing movement of the surgical instrument (170) when the surgical instrument (170) is outside both the observation space and the safety volume (VS); - allowing the surgical instrument (170) to move from the safety volume (VS) back into the observation space and / or field of view (FOV) space and / or within the limits of the observation space, and maintaining a teleoperated state.

25. Permitting movement of the surgical instrument (170) in a restricted mode of operation includes: - controlling said slave device to move at a limited or reduced speed that is lower than the maximum speed achievable and / or allowed when said slave device is inside said observation space; and / or - controlling the slave device such that it moves between the master device and the slave device with an increased scale factor relative to a scale factor inside the observation space.

26. Permitting movement of the surgical instrument (170) in a restricted mode of operation includes: The method according to claim 24 or 25, comprising, when the surgical instrument reaches the edge or limit of the safety volume (VS), only allowing movement of the surgical instrument along the edge or limit of the safety volume (VS) or temporarily blocking the surgical instrument at the point where it reaches the edge or limit.

27. 27. The method of any one of claims 24 to 26, wherein enabling movement of the surgical instrument (170) in a restricted mode of operation comprises constraining or restricting one or more degrees of freedom of the surgical instrument (170).

28. Allowing the surgical instrument (170) to return from the safety volume (VS) to the observation space includes: - Differentiating between phases of exiting and / or moving away from the observation space of the surgical instrument (170), in which the distance of the surgical instrument from the edge of the observation space increases, and the safety volume (VS) is an exit safety volume calculated in relation to the phases of entering, exiting and / or moving away from the observation space of the surgical instrument (170) from a return phase towards the observation space, in which the distance of the surgical instrument from the edge of the observation space decreases; - calculating a return safety volume included in and other than said safety volume at the beginning and end of said return phase; - controlling the movement of the surgical instrument (170) during the return phase so that the surgical instrument (170) remains within the return safety volume.

29. the return safety volume has a containment volume, such as the trunk of a containment cone or another containment geometry, that includes all coordinates traveled by the surgical instrument (170) during the exit and distancing phases; controlling the movement of the surgical instrument (170) during the return phase comprises constraining the surgical instrument (170) to remain within the return safety volume by a translational or velocity limit; 29. The method of claim 28, wherein the return velocity is less than the exit velocity.

30. 30. The method of any one of claims 1 to 29, comprising maintaining the robot system and the slave device in a teleoperated state when the surgical instrument (170) is within the observation space or the safety volume (VS).

31. 30. The method of any one of claims 1 to 29, comprising ceasing teleoperation of the robotic system or exiting teleoperation of the robotic system when the surgical instrument (170) exits the safety volume and exits both the safety volume and the observation space.

32. 32. The method of claim 1, further comprising allowing and / or enabling an alignment operation between the master device (110) and the slave device (170) and / or allowing entry into teleoperation, even if the surgical instrument (170) is outside the observation space, but only if it is inside the safety volume (VS) or when exiting from a teleoperation phase and reaching an edge or limit of the safety volume (VS).

33. the robotic system having a plurality of slave devices and respective surgical instruments; 33. The method of any one of claims 1 to 32, wherein the method steps are performed for each slave device and each surgical instrument.

34. 34. The method of any one of claims 1 to 33, further comprising providing a visual and / or audible and / or tactile warning to an operator when the device approaches a limit or edge of the observation space and / or when the device approaches a limit or edge of the safety volume (VS).

35. 35. The method of any one of claims 1 to 34, further comprising providing an actuation means, e.g., a pedal, that when actuated by an operator of the robotic system allows movement of the surgical instrument outside the observation space or the safety volume.

36. 36. The method of any one of claims 1 to 35, further comprising providing visual elements on a screen to guide an operator while executing a return of the surgical instrument (170) to the observation space or while informing the operator of the exit of the surgical instrument (170) from the observation space.

37. A medical or surgical teleoperated robotic system (100), comprising: at least one master device (110) adapted to be moved by an operator (150); at least one slave device having a surgical instrument (170) adapted to be controlled by said master device; a viewing means configured to display to the operator (150) images and / or videos of a viewing space associated with a remote control area in which the surgical instrument (170) is operated; a control unit configured to control the slave device based on an operation of the master device during remote operation; Equipped with The control unit - defining a safety volume (VS) included in the slave workspace but outside the observation space, according to the criteria that the risk of contact between the surgical instrument (170) and the patient's anatomical parts or elements supporting the surgical operation is limited or eliminated and that in the safety volume (SF) a safe level of movement of the surgical instrument (170) is ensured; - determining the position of the surgical instrument (170) and determining whether the surgical instrument (170) is inside the observation space, outside the observation space but inside the safety volume (VS), or outside the safety volume (VS); - the robotic system is further configured to control the movement of the slave device in a manner dependent on the determined position of the surgical instrument (170), such that movement of the surgical instrument (170) is permitted in a restricted operating mode even when the surgical instrument (170) is outside the observation space but inside the safety volume (VS).

38. The safety volume (VS) is based on geometric or structural criteria of the slave device or the surgical instrument, and / or based on the shape and structure of the robotic system, and / or based on the surgical setup; and / or - Regarding operating tables: defined, 38. The robotic system of claim 37, wherein the surgical worktable defines a surface on which robotic surgery is performed during teleoperation, or a boundary of a working area for surgical instruments proximate a patient's anatomy.

39. The safety volume (VS) is the outer perimeter of the observation space beyond its boundaries by a spatial tolerance (ε), and / or a cone or cone-shaped stem defined around the direction of exit of the surgical instrument from the viewing space, and / or - a cylinder or lumen volume defined along the longitudinal axis of the surgical instrument, and / or a convex polyhedron dependent on the exit point of the surgical instrument (170) relative to the observation space, defined so as to exclude parts of the space that are closer to the surgical table than the exit point is to the surgical table, so as not to cross the surgical table and / or the work surface on which the surgical instrument was previously working; and / or a volume or half-space that includes all points further from the operating table than the focal point of the observation system, and / or - a hollow-shaped volume having an angled opening calculated or estimated from the leading angle of the axis of the surgical instrument (170), and including a point further from the surgical table than the focal point of the observation system; 39. The robotic system of claim 38, comprising:

40. 40. The robotic system of claim 38 or 39, wherein the safety volume (VS) is dynamically defined during teleoperation according to a determined or recorded most recent exit point of the surgical instrument (170) from the observation space.

41. the safety volume (VS) comprises the outer perimeter of the observation space; 41. The robotic system of claim 39 or 40, wherein the spatial tolerance (ε) is a predefined constant value or a dynamically variable value defined as a function of the velocity of the surgical instrument (170) when exiting the observation space or as a function of a scale factor between the movement of the master device and the resulting movement of the slave device.

42. the safety volume (VS) has a cone or cone-shaped stem with a height and angled opening around the direction of exit of the surgical instrument from the observation space; 41. The robotic system of claim 39 or 40, wherein the height and angled opening depend on an exit speed of the surgical instrument (170) from the observation volume, or on a scale factor between movement of the master device and the resulting movement of the slave device, or on other motion parameters of the robotic system.

43. the angled opening is inversely proportional to the exit velocity or directly proportional to the scale factor; the height H is directly / inversely proportional to the exit velocity or directly / inversely proportional to the scale factor; 43. The robotic system of claim 42, wherein the angular opening of the cone relative to a coordinate associated with the view space is calculated / estimated as a function of the direction in which the surgical instrument reaches the limit of the view space.

44. 41. The robotic system of claim 39 or 40, wherein the safety volume (VS) has a cylinder or lumen volume defined along a longitudinal axis of the surgical instrument to only permit movement of the surgical instrument along or about its dominant axis when the surgical instrument is outside the observation space (FOV).

45. the safety volume (VS) comprises the convex polyhedron; 41. The robotic system of claim 39 or 40, wherein movement of the surgical instrument out of the observation space and movement of the surgical instrument outside the observation space are not permitted in approaching the surgical work table in a direction (Z) perpendicular to the surgical work table (XY).

46. the observation space is defined by a field of view (FOV) of the observation means; 46. ​​The robotic system of claim 37, wherein controlling movement of the slave device in a manner dependent on the determined position of the surgical instrument comprises permitting movement of the surgical instrument in a normal operating mode when the surgical instrument is within the field of view (FOV).

47. 47. The robotic system of any one of claims 37 to 46, wherein the act of defining the safe volume (VS) comprises calculating the safe volume (VS) by one or more computer vision algorithms operating in real time based on digital data derived from the observation means.

48. 47. The robotic system of any one of claims 38 to 46, wherein the act of defining the safe volume (VS) comprises calculating the safe volume (VS) based on digital data derived from a second observation means having a second field of view (FOV2) or by one or more computer vision algorithms operating on digital data / images recorded at a pre-operational stage.

49. 46. ​​The robotic system of any one of claims 38 to 45, wherein the safety volume is defined as a volume surrounding the observation space, excluding sub-volumes or non-penetrating sub-regions in which movement of the surgical instrument is not permitted.

50. 46. ​​The robotic system of any one of claims 38 to 45, wherein the act of defining the safe volume (VS) comprises calculating the safe volume (VS) as a volumetric extension of the observation space and / or based on kinematic or mechanical information of the robotic system and / or the slave device.

51. The operation of defining the safety volume (VS) is - recording an exit point and an exit orientation of said surgical instrument from said observation space based on digital data or images provided by said observation means, and expressing said exit point and said exit orientation in coordinates referenced to the coordinate system of said slave workspace; - calculating or defining the safety volume (VS) based on the exit point and the exit orientation of the surgical instrument from the observation space.

52. 52. The robotic system of any one of claims 37 to 51, wherein the operation of determining the position of the surgical instrument (170) comprises determining the current position of the surgical instrument (170) and / or the presence of the surgical instrument (170) in the observation space based on digital data derived from the observation means.

53. The act of determining the position of the surgical instrument (170) comprises: - mapping said observation space into a slave viewing workspace corresponding to a slave reference coordinate system associated with said slave device; - determining the position of said surgical instrument (170) in respective position coordinates in said slave reference coordinate system; - determining a position of the surgical instrument (170) relative to the observation space based on a comparison of the position coordinates with the slave field of view workspace in the slave reference coordinate system.

54. The control unit - defining a slave kinematic workspace (175) in a slave reference frame (SFO) based on physical travel limits of the slave device and / or motion constraints that are not correlated to the observation means; - further configured to perform the operation of defining, in said slave reference coordinate system, an actual slave workspace (200) corresponding to the intersection of said slave field of view (FOV) workspace and said slave kinematic workspace (175); 54. The robotic system of claim 53, wherein the operation of controlling movement of the slave device comprises controlling movement of the slave device such that movement of the surgical instrument (170) is permitted when the surgical instrument (170) is inside the actual slave workspace (200).

55. 55. A robotic system as described in any one of claims 52 to 54, wherein the operation of determining the position of the surgical instrument (170) is performed periodically and / or continuously to confirm the position or presence of the surgical instrument (170) in the observation space or the actual slave workspace (200) in real time.

56. The act of determining the position of the surgical instrument (170) comprises: - calculating and / or determining the positions of real points belonging to said surgical instrument or the positions of virtual points integral with said surgical instrument (170), and / or - calculating and / or determining the position of the virtual control point (600) of said slave device, and / or - determining the position of at least one of the tips (171, 172) of said surgical instrument (170), and / or - determining the position of at least one of the links of a hinged wrist (177) included in said surgical instrument (170), and / or - determining the position of a distal portion of a positioning shaft (179) proximal to the hinged wrist (177) of the surgical instrument (170).

57. the observation space comprises the field of view (FOV) of the observation means, or a predefined subset of the field of view (FOV), or a workspace of the field of view (FOV), or the actual slave workspace (200); the control unit is further configured to perform an operation of defining limits or edges of the observation space; 55. The robotic system of claim 46 or 54, wherein the limits or edges define upper and lower thresholds for allowed movement of the slave device.

58. the limit or edge has a threshold boundary in a plane (XY) perpendicular to the depth direction (Z) of the field of view (FOV); said threshold boundaries define upper / lower thresholds for movement within said plane (XY) and / or along orthogonal axes (X, Y) belonging to said plane (XY); 58. The robotic system of claim 57, wherein the threshold boundary is calculated as a function of the distance of a plane (XY) relative to the observation means.

59. the limits or edges have lower / upper thresholds along the depth (Z) axis of the field of view (FOV) in addition to the threshold boundaries in a plane (XY); 59. The robotic system of claim 58, wherein the lower / upper thresholds along the depth (Z) axis are determined based on good focus of the observation means assessed and calculated in real time using data provided by the observation means, or based on the depth of field of the observation means in a given configuration.

60. The operation of controlling the movement of the slave device includes: - allowing the surgical instrument (170) to exit from the space of the observation space and / or field of view (FOV) and / or the limitations of the observation space; - when the surgical instrument (170) is outside the observation space but inside the safety volume (VS), maintaining a remote control state and allowing movement of the surgical instrument (170) in a limited operating mode; - not allowing movement of the surgical instrument (170) when the surgical instrument (170) is outside both the observation space and the safety volume (VS); - allowing the surgical instrument (170) to move from the safety volume (VS) back into the observation space and / or field of view (FOV) space and / or within the confines of the observation space, and maintaining a teleoperated state.

61. The operation of permitting movement of the surgical instrument (170) in a restricted mode of operation comprises: - controlling said slave device to move at a limited or reduced speed that is lower than the maximum speed achievable and / or allowed when said slave device is inside said observation space; and / or - controlling the slave device such that the slave device moves between the master device and the slave device with an increased scale factor relative to a scale factor inside the observation space.

62. The operation of permitting movement of the surgical instrument (170) in a restricted mode of operation comprises: - When the surgical instrument reaches the edge or limit of the safety volume (VS), the robotic system comprises: only allowing movement of the surgical instrument along the edge or limit of the safety volume (VS) or temporarily blocking the surgical instrument at the point where the surgical instrument reaches the edge or limit.

63. 63. The robotic system of any one of claims 60 to 62, wherein the operation of enabling movement of the surgical instrument (170) in a restricted mode of operation comprises constraining or restraining one or more degrees of freedom of the surgical instrument (170).

64. The action of allowing the surgical instrument (170) to return from the safety volume (VS) to the observation space comprises: - Differentiating between phases of exiting and / or moving away from the observation space of the surgical instrument (170), in which the distance of the surgical instrument from the edge of the observation space increases, and the safety volume (VS) is an exit safety volume calculated in relation to the phases of entering, exiting and / or moving away from the observation space of the surgical instrument (170) from a return phase towards the observation space, in which the distance of the surgical instrument from the edge of the observation space decreases; - calculating a return safety volume included in and other than said safety volume at the beginning and end of said return phase; - controlling the movement of the surgical instrument (170) during the return phase so that the surgical instrument (170) remains within the return safety volume.

65. the return safety volume has a containment volume, such as the trunk of a containment cone or another containment geometry, that includes all coordinates traveled by the surgical instrument (170) during the exit and distancing phases; The operation of controlling the movement of the surgical instrument (170) during the return phase comprises constraining the surgical instrument (170) to remain within the return safety volume by a translational or velocity limit; 65. The robotic system of claim 64, wherein the return speed is less than the exit speed.

66. 66. The robotic system of any one of claims 37 to 65, wherein the control unit is further configured to maintain the robotic system and the slave device in a teleoperated state when the surgical instrument (170) is within the observation space or the safety volume (VS).

67. 66. The robotic system of any one of claims 37 to 65, wherein the control unit is further configured to perform an action to stop teleoperation of the robotic system or to exit a teleoperated state of the robotic system when the surgical instrument (170) exits the safety volume and exits both the safety volume and the observation space.

68. The control unit 68. The robot system of any one of claims 37 to 67, further configured to perform operations that allow and / or enable alignment operations between the master device (110) and the slave device (170) and / or allow entry into teleoperation, even if the surgical instrument (170) is outside the observation space, but only if it is inside the safety volume (VS) or when it exits from the teleoperation phase and reaches the edge or limit of the safety volume (VS).

69. the robotic system having a plurality of slave devices and respective surgical instruments; 69. The robotic system of any one of claims 37 to 68, wherein the operation is performed for each slave device and each surgical instrument.

70. 70. The robotic system of any one of claims 37 to 69, wherein the control unit is further configured to provide a visual and / or audible and / or tactile warning to an operator when the device approaches a limit or edge of the observation space and / or when the device approaches a limit or edge of the safety volume (VS).

71. 71. The robotic system of any one of claims 37 to 70, wherein the control unit is further configured to provide actuation means, such as a pedal, that when actuated by an operator of the robotic system allows movement of the surgical instrument outside the observation space or the safety volume.

72. 72. The robotic system of any one of claims 37 to 71, wherein the control unit is further configured to provide visual elements on a screen to guide an operator while executing the return of the surgical instrument (170) to the observation space or while informing the operator of the exit of the surgical instrument (170) from the observation space.

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