Systems, methods, and computer programs for autonomously performing medical procedures

Abstract

The present invention relates to a system (1), method, and computer program for autonomously performing a medical procedure comprising at least one step. The system (1) comprises a computing unit (3), an interface (4) for communicating with at least one actuator (5) for operating a surgical robot (6), and a user interface (2) for inputting user commands. The computing unit (3) autonomously controls the operation of the actuator (5) to perform at least one step of the medical procedure, receives control commands in one form of a change command, a stop command, and a continue command from the user interface (2), and is adapted to trigger a change, stop, or continue operation of the actuator based on the control command.

Description

Technical Field

[0001] The present invention relates to a system, a method, and a computer program for autonomously performing a medical procedure described in the independent claims.

Background Art

[0002] Robotic surgery or robot-assisted surgery enables a surgeon to perform many types of complex procedures with higher precision, flexibility, and control than possible with conventional techniques. Robotic surgery is typically associated with minimally invasive surgery, i.e., procedures performed through small incisions. It may also be used in certain traditional open surgical procedures.

[0003] The most widely used clinical surgical robots include a camera arm and a mechanical arm to which surgical instruments are attached.

[0004] As shown in "Autonomy in Surgical Robots" (Annual Review of Control, Robotics, and Autonomous Systems, Volume 4, 2021, Attanasio, pp 651-679), the autonomy achievable by a surgical robot system can be classified into six levels, inspired by the classification method and definition of the levels of autonomy according to the SAE J3016 standard (2) that defines similar levels for road autonomous vehicles based on the initial proposal by Yang et al. (2017, Medical robotics-regulatory, ethical, and legal considerations for increasing levels of autonomy, Sci. Robot., 2:eaam8638).

[0005] The six levels are defined as follows: Level 0 (No Autonomy, Robot movement is exclusively controlled by the operator, with no support or constraints provided), Level 1 (Robot Assistance, System provides active constraints to guide operator movement or virtual fixation devices to improve visualization of the surgical site), Level 2 (Task Autonomy, System can accomplish specific surgical tasks based on specifications provided by the operator), Level 3 (Conditional Autonomy, System understands surgical scenarios, plans and executes specific tasks, and updates the plan during execution), Level 4 (High Autonomy, System interprets preoperative and intraoperative information, devises an intervention plan consisting of a set of tasks, executes this plan autonomously, and replans as needed), and Level 5 (Full Autonomy).

[0006] Autonomous driving has reached Level 3 (conditional autonomy) and is approaching Level 4 (high autonomy), but commercially available platforms for robotic surgery remain completely at Level 0 (no autonomy).

[0007] For example, Level 0 robot-assisted surgery is known to include mitral valve repair, thoracoscopic surgery, and robot-assisted surgery.

[0008] In the context of surgical robotics, ethical and legal concerns arise regarding the consequences of misjudgments and erroneous robotic behavior that could lead to serious injury or even death. [Overview of the project] [Problems that the invention aims to solve]

[0009] The objective of the present invention is to overcome the shortcomings of the prior art. In particular, the systems and methods according to the present invention provide robotic surgery that meets clinical needs, especially applicable legal requirements, and enables a high level of autonomy. [Means for solving the problem]

[0010] These and other objectives are addressed by the systems, methods, and computer programs described in the independent claims.

[0011] The present invention provides a system for autonomously performing a medical procedure that includes at least one step.

[0012] The system comprises a computing unit, an actuator interface for communicating with at least one actuator for operating at least one surgical robot, and a user interface for inputting user commands. In this application, the user is generally a human user.

[0013] Actuators are components that convert electrical signals into mechanical motion or other physical actions, such as increased pressure or changes in temperature, and are responsible for moving or controlling mechanisms or systems of surgical robots, for example, by moving components or opening valves.

[0014] The system is connected to or can be connected to actuators, particularly actuators of surgical robots or surgical devices, via an actuator interface.

[0015] The system may include actuators, particularly surgical robots equipped with actuators.

[0016] Within this application, a surgical robot may comprise a light source, a sensor device, and / or at least one robotic arm to which a surgical instrument is attached or can be attached. The sensor device may include, for example, a camera or an ultrasound probe. The surgical instrument may comprise surgical tools such as guide wires, endoscopes, puncture needles, and deployment tools including implant valves or expansion balloons, or may be functionally connected to surgical tools.

[0017] The computing unit is adapted to autonomously control the operation of the actuator so as to execute at least one of at least one step of the medical procedure.

[0018] The control of the actuator is achieved by providing respective control signals at the actuator interface.

[0019] The computing unit may also be adapted to perform an operation induced by the user of the actuator to execute a step of the medical procedure.

[0020] The computing unit is further adapted to receive a control command from the user interface in one form of a change command, a stop command, and a continue command.

[0021] The change command may serve to select, define, and / or modify a surgical step performed by the surgical robot.

[0022] The change command may be a new command that does not refer to a surgical step that is pending or in execution.

[0023] The stop command serves to end or interrupt a surgical step or a series of surgical steps.

[0024] The continue command serves to verify or confirm a surgical step or a series of surgical steps.

[0025] The computing unit is further adapted to induce a change operation, a warning signal, a continue signal, a stop operation, or a continue operation of the actuator based on the control command.

[0026] The computing unit may be adapted to generate a signal based on the control command and transmit the signal to the actuator interface.

[0027] The computer unit may be adapted to plan and / or execute at least one step of a medical procedure. To plan and execute the steps, the computer unit may be adapted to use AI (artificial intelligence) software.

[0028] The computing unit can provide an autopilot function for executing at least one step of a medical procedure.

[0029] The computing unit may be adapted to simulate surgical steps, in particular to determine critical phases and critical areas.

[0030] The computing unit may be adapted to determine the next step of a medical procedure and generate output data providing information about possible subsequent steps and / or their implications.

[0031] The computing unit may be adapted to calculate the results of user inputs / user modifications and determine the risks that may be associated with each input.

[0032] The computing unit may assist in surgical steps that are fully controlled by the user, for example, during a surgical step, for example, emit audio and / or optical signals during navigation to assist in localization or suppress the tremor movements of the operator.

[0033] The computing unit may be adapted to verify surgical steps, for example, verify that an implant is correctly positioned and fixed by the operator.

[0034] The computing unit may be adapted to log the steps of a medical procedure and the interactions with the operator / user.

[0035] The actuator interface may include sockets or plugs for coordinating with plugs or sockets of a surgical robot. The actuator interface may also include wireless connectivity for coordinating with a surgical robot.

[0036] The user interface may be a master interface for communicating with medical staff. The user interface may include at least one of the following: a monitor, keyboard, touchscreen, joystick, handle, control panel, motion tracker, gaze tracker, microphone and voice recognition device, speaker, camera, and image recognition device.

[0037] A medical procedure can be divided into multiple separate steps. Each step may first be associated with a predetermined autonomous mode.

[0038] For example, a medical procedure may begin with a preparation step in which the equipment in the operating room is checked.

[0039] In a further step, a cart carrying the robot and camera may enter the operating room. An external camera fixed inside the room may be connected. The camera may be calibrated as needed. The cart may be positioned relative to the desired working position and may be locked to a reference point, for example, on the ground or on a table.

[0040] The robot may be positioned on either side of the table, preferably near the desired access site, preferably in the center relative to the patient's length, for example, between the patient's knees and stomach.

[0041] The patient's access sites may be known from preoperative information or detected, for example, by drape openings.

[0042] In a further step, the system may be configured to establish and / or check all connections, including power supplies for all components. The software may be started, and consumables for the medical procedure may be prepared.

[0043] In a further step, the system may be initialized. This includes checking whether all software components are available and operational, and setting up for patient detection and robot homing.

[0044] The above steps may initially be associated with a fully automatic mode, or they may be performed fully automatically on a regular basis. Human verification and / or control commands may be requested and received on request, for example, in the event of unexpected or unpredictable events.

[0045] In subsequent steps, the actual medical procedure is initiated. For example, in the case of a puncture procedure, patch detection and robotic arm movement may be initiated. This step may initially be performed in a partially degraded autonomous mode. Human verification and / or control commands may be requested and received.

[0046] Additionally, an ultrasound scan may be initiated. Arteries and puncture sites may be automatically detected. This step may initially be performed in a partially degraded autonomous mode. Human verification and / or control commands may be requested and received.

[0047] In the subsequent puncture step, the needle may be inserted and stopped. This step may initially be performed in a partially degraded autonomous mode. Human verification or human intervention may be required.

[0048] In a subsequent step, an introducer may be deployed. This step may initially be performed in a partially degraded autonomous mode. Human verification or human intervention may be required.

[0049] Finally, the robot can be pulled in. This step may be performed initially in fully automated mode, or periodically in fully automated mode.

[0050] During, before, and after each step, the system may be adapted to switch to a less autonomous mode automatically or in accordance with the respective commands entered by the user via the user interface. The system may also be adapted to automatically request or receive the above control commands before, after, and / or during each step.

[0051] For example, the system may be adapted to automatically request or receive the control commands during the step in case of an emergency detected by the system, the user, or an external system.

[0052] Alternatively, the system may be adapted to automatically request the receipt of the above control commands before and / or after a series of steps.

[0053] Depending on the predetermined importance of each step, the system may be adapted to automatically request that control commands be received only before the more important steps.

[0054] The system may also be adapted to automatically request the receipt of the above control commands during a step, for example, when a single step takes a longer time, such as a navigation step.

[0055] The computing unit may be adapted to receive emergency shutdown commands at any time.

[0056] The operator may be prompted by the system to verify each step, or to verify only individual steps. The operator may interact at each step.

[0057] The computing unit may be capable of operating in autonomous mode, fully degenerate mode, and partially degenerate mode.

[0058] In autonomous mode, the computing unit completely controls the operation of the actuators, and consequently, the non-mechanical operations.

[0059] In autonomous mode, the system completes each step without human verification. The system operates fully based on non-human input. Autonomous mode corresponds to Level 5 (fully autonomous) as described above.

[0060] In fully degraded mode, the computing unit either releases the actuators so that the user can operate them manually in manual degraded mode, or the computing unit controls the actuators based on remote control commands provided by the user in remote degraded mode.

[0061] In manual degraded mode, the system operates entirely manually. The operator can directly and physically interact with the surgical robot.

[0062] Alternatively, the surgical robot may be operated in a remotely controlled degraded mode, where the actuators are controlled by a computing unit that receives remote control commands from a remote user interface. The operator can directly control the surgical robot via the computing unit.

[0063] In fully degenerate mode, the computing unit only needs to provide output to the actuator interface based on human input, i.e., transmit control signals. The computing unit does not perform any decision-making processes and leaves the entire control to the operator. However, even in fully degenerate mode, there may be some algorithmic autonomy that does not interfere with the operator's actions, such as tremor suppression and redundancy resolution.

[0064] The fully degenerate mode corresponds to level 0 as described above. In partial degenerate mode, the computing unit controls the actuators to perform at least one step of a medical procedure based on communication with the user.

[0065] It is possible to distinguish between different levels of partial degeneracy modes. The system may operate autonomously under supervision. The user may provide go / no-go input at each predetermined step. The system may operate fully with non-human input, except for verification at intermediate steps. The level corresponds to Level 4 (high autonomy) as described above, where the computing unit interprets preoperative and intraoperative information, devises an intervention plan consisting of a series of tasks, autonomously triggers the execution of this plan, and replans it as needed. The operator supervises the system under a separate control paradigm.

[0066] In partial degenerate mode, the system may operate in a degenerate manner, but can be augmented to correspond to levels 1, 2, and / or 3 as described above.

[0067] At Level 1, the system can provide some support to the operator / user, but can never control the actions being performed. The system can support the operator in performing specific surgical procedures. The system may provide passive assistance, for example, by providing additional information to the operator when requested. The system may provide augmented imaging, such as augmented reality. The system may provide an active assistance system, for example, when limiting the movement of surgical instruments.

[0068] At Level 2, the computing unit can control the steps of the procedure, but it is not able to define arbitrary parameters for planning the task. The operator provides the information necessary to perform the action.

[0069] At Level 3, the system can conceive strategies for performing specific tasks, while always relying on a human operator to approve the optimal strategy to be implemented. Some parts of the procedure, such as navigating a flexible endoscopic robot in an unstructured environment or locating access points for intraluminal surgery, may be performed autonomously.

[0070] In full and partially degenerate modes, the system can receive direct input via a GUI (e.g., for selecting the access point of the lumen inlet) and / or other input systems (e.g., a gamepad for setting the needle depth or the position and orientation of the ultrasound probe).

[0071] In full and partial degenerate modes when a step is not validated, the system can await human input, which may be a retry command or direct instruction (for example, if the access point determined by the AI ​​is incorrect, the user can specify, via the GUI, where the actual access point should be).

[0072] The system may include a switch unit for switching operation between autonomous mode, fully degenerate mode, and / or partially degenerate mode.

[0073] Alternatively or additionally, the system may include a switch unit for switching operation between different levels of partial degeneration modes.

[0074] Preferably, the operating mode is selected before the first step of the medical procedure. However, the switch unit may be adapted to switch operations on demand at any time during the medical procedure. In this way, the operator can modify the level of autonomy corresponding to the course of the surgical procedure. The operator may take more control or relinquish control to the system if they deem it necessary.

[0075] In autonomous mode and partially degraded mode, surgical procedure steps may be performed automatically until they are stopped or until a stopping criterion is reached.

[0076] The operator may be compelled by the system to supervise steps being executed automatically, for example, by a dead man's switch.

[0077] The switch unit can be controlled by a computing unit to automatically switch its operation from autonomous mode to fully or partially degraded mode, and to switch its operation back to autonomous mode only upon command or verification by the user.

[0078] Similarly, the operation can automatically switch to a lower level of autonomy, but changes to a higher level of autonomy require user instruction and / or verification.

[0079] Generally, computing units can operate within a pyramidal structure of decision-making. The lowest level is associated with low-level signal processing, the next level uses AI (artificial intelligence) for image and / or sensor processing, the next level uses AI for contextual interpretation, and at the highest level, every step of a procedure can be controlled by the computing unit.

[0080] Context-aware AI can reduce the level of autonomy or stop a procedure, but it cannot increase the level of autonomy.

[0081] However, the computing unit grants the operator full authority at any point in the procedure for any level of autonomy, if requested by the operator.

[0082] The computing unit may be adapted in particular to change the level of autonomy to a higher level of autonomy in order to receive switching commands from the user interface described above and / or to trigger a switching based on the switching commands.

[0083] The system may include a verification interface for inputting verification commands. The verification interface is preferably selected from the group consisting of a voice interface, a mechanical button or switch, a mouse, a joystick, a tactile glove, a graphical user interface, in particular a touchscreen, a motion detector, in particular an eye-tracker or head motion detector, a virtual reality or augmented reality interface, an eye-image interface, a 3D monitor, in particular a tactile glove or hologram presentation combined with motion detection, and a timer.

[0084] The validation interface may be an interface for user input. The user interface may include the validation interface.

[0085] Alternatively or additionally, the verification interface may receive non-human inputs, such as from a timer or sensor device.

[0086] The computing unit may be adapted to receive signals from external devices such as timers or sensors via a verification interface, compare them to predetermined conditions, and provide signals or actions based on that comparison.

[0087] The system may include a change interface for inputting change commands and start, continue, hold, or stop commands. The change interface is preferably selected from the group consisting of a voice interface, mechanical buttons or switches, a mouse, a joystick, a tactile glove, a keyboard, a graphical user interface, in particular a touchscreen, a motion detector, in particular an eye-tracker or head motion detector, an eye-image interface, a virtual reality or augmented reality interface, and a holographic presentation in combination with a 3D monitor, in particular a tactile glove or motion detector.

[0088] A change interface is an interface for user input to a system, particularly a computing unit, and a user interface may include a change interface.

[0089] Preferably, the system is suitable for use in intraluminal procedures, particularly endovascular or gastrointestinal surgical procedures such as placing and fixing implants within a patient's body cavity.

[0090] The modification instructions may be selected from a group consisting of defining access points for entering the patient's body, defining the position of the surgical robot relative to the access points for entering the patient's body, defining the implant position, defining the speed and trajectory of implant insertion, defining the target position and / or orientation of the implant, defining deployment parameters for deploying the implant, in particular the balloon pressure for expanding the implant, defining the retraction and orientation and speed of the imaging device, in particular the endoscopic camera, and defining checklists and / or to-do lists including steps of intervention.

[0091] The checklist, which includes the steps of intervention, may be defined in a machine-readable format and / or in a format for outputting the list on an output interface so that the user can check, modify, and / or update the list.

[0092] In this context, “define” means that all information relating to each action is entered by the user, or that the computing unit is adapted to define the information required for each action on demand, or that the computing unit is adapted to correct a given action.

[0093] The modification instruction may include complete information about each action, meaning each action is fully defined by information entered by the user, or the modification instruction may include commands for each action, meaning the computer unit determines the information required for each action.

[0094] The computing unit may define its actions based on data entered by the user, based on data in a system or a database stored in memory, and / or based on data provided by a further system, such as a sensor device.

[0095] For example, to define access points to enter a patient's body, the user may input all data on selected target areas on the patient's body, or the computing unit may be prompted, for example, via a modification interface to calculate access points based on image analysis. Each modification instruction may relate to a modification of a previously input or previously defined access point.

[0096] For example, to define the position of a surgical robot relative to an access point for entering a patient's body, the user may input all the data necessary to position the surgical robot, or they may directly position the surgical robot in a selected orientation at a selected site, for example, via a modification interface. In this case, the computing unit operates based on the modification instructions input by the user.

[0097] Alternatively, each modification instruction may relate to initiating a positioning routine that allows the computing unit to define the path and orientation of the surgical robot and / or to autonomously control the movement of the surgical robot.

[0098] Alternatively, the change command may relate to a previously entered or previously calculated change in the position and orientation of the surgical robot.

[0099] Similarly, to define, for example, the implantation site of a heart valve, the user may input all the data for the final implant site, for example, through a modification interface, or the computing unit may be adapted to define the implant site, and the user may input commands to define the implantation site.

[0100] Alternatively, each change instruction relates to a change in the previously entered or previously determined implant location.

[0101] Similarly, particularly for intravascular placement of heart valves, the user may input all data on the speed and trajectory of implant insertion, for example, via a modification interface, in order to define the speed and trajectory of implant insertion. Alternatively, a computing unit may be adapted to define the speed and trajectory of implant insertion and prompt to determine the speed and trajectory.

[0102] Alternatively, each modification instruction may relate to a change in the previously entered or previously determined velocity and trajectory of implant insertion.

[0103] Similarly, to define the detailed position and / or orientation of the implant, the user may input all data regarding the detailed position and / or orientation of the implant, for example, through a modification interface, or the computing unit may be adapted to define the detailed position and / or orientation of the implant, and the user may input commands to prompt the computer unit to define the detailed position and / or orientation.

[0104] Alternatively, each modification instruction may relate to a previously defined detailed change in the position and / or orientation of the implant.

[0105] Similarly, to define the deployment parameters for deploying an implant, the user may input all the data for the deployment parameters, for example, through a modification interface, or the computing unit may be prompted to determine the deployment parameters. Alternatively, each modification instruction relates to a modification of previously entered or previously determined deployment parameters.

[0106] Similarly, to define the orientation and speed of an appliance during installation, the user may input all the appliance orientation and speed data, for example, via a change interface, or the computing unit may be adapted to define the appliance orientation and speed, and the user may input commands to trigger the calculation of the orientation and speed. Alternatively, each change command may relate to a change in the previously defined orientation and speed of the appliance.

[0107] For example, to define a checklist that includes all steps of an intervention, all or some of the steps may be manually entered by the user, and / or the steps may be suggested by the system, and / or the checklist may be edited during planning, and / or the checklist may be updated automatically or manually.

[0108] The system may further include a stop interface for inputting a stop command. The stop interface is preferably selected from the group consisting of a voice interface, a mechanical button or switch, a mouse, a joystick, a tactile glove, a keyboard, a graphical user interface, in particular a touchscreen, a motion detector, in particular an eye-tracker or head motion detector, a virtual reality or augmented reality interface, a 3D monitor, in particular a tactile glove or hologram presentation combined with motion detection, a timer, a button, and a detection device for detecting risks or unexpected events.

[0109] The detection device may be a device for detecting environmental conditions, a device for detecting system status, or a device for detecting patient characteristics such as a patient's vital signs. The detection device may provide a stop command when the signal captured by the detection device falls below or exceeds a predetermined threshold.

[0110] The detection device may issue a stop command if a system component malfunction is detected, or if the patient exhibits unexpected behavior, such as starting to move.

[0111] A stop command may allow the computing unit to immediately halt the surgical step or reduce its level of autonomy.

[0112] The system may have memory for storing risk levels associated with at least one of the steps described above.

[0113] Risk levels may be stored in advance. The operator may assign a specific predetermined risk level to each step, and / or the operator may specify a specific risk level. The operator may change the risk level of the procedure step in progress.

[0114] The operator may change the risk level of at least one step before the medical procedure, or during the medical procedure, but before the step is performed.

[0115] A specific risk level may be associated with each predetermined instruction criterion, for example, each user input.

[0116] A specific risk level may be associated with a specific required number of validation instructions. For example, a high-risk step may require the user to input at least two validation instructions, particularly before, during, and / or after the step. A step may require step-by-step instructions relating to a broader aspect on the one hand, and a more specific aspect of the step on the other.

[0117] Steps with a moderate risk level may require only one verification instruction. Steps with a low risk level may require no verification at all.

[0118] Verification instructions may also be go / no-go instructions. The computing unit may be configured to execute a modification instruction only if a predetermined instruction criterion is met for each risk level of each step.

[0119] A medical procedure may be divided into multiple separate steps, and the system is adapted to automatically request to receive the user commands before or after the first step, or before or after the last step, and especially only before the first step and / or after the last step. In this case, the system typically operates in autonomous mode, and periodic user input is not required during the medical procedure.

[0120] The system may be adapted for medical procedures involving intravascular access or intraluminal access, such as gastrointestinal access.

[0121] The system may be adapted for intraluminal procedures that involve body tubules or cavities, such as TAVI procedures, obesity procedures, bronchoalveolar procedures, ureteral bladder procedures, or vaginal uterine procedures.

[0122] In particular, the system may be adapted for TAVI (transcatheter aortic valve implantation) procedures. The steps of a medical TAVI procedure may include at least one of the following: preoperative steps, planning steps, robotic movement steps, puncture steps, navigation steps, intermediate steps, valve placement steps, and closure steps.

[0123] The preoperative steps may include imaging, particularly 3D reconstruction. The preoperative steps may include a simulation of at least several steps of the TAVI procedure, preferably the entire TAVI procedure. The preoperative steps may include determining critical phases of the procedure and critical areas within the patient. The user may define the respective risk levels associated with the steps and / or patient areas, or a computer unit may evaluate the phases of the procedure and patient areas. The preoperative steps may include setting warning marks for each critical phase of the procedure or for each critical area of ​​the patient. Warning marks may be provided during subsequent steps of the medical procedure.

[0124] Preoperative steps may include, in particular, widening calcified blood vessels or congenital valves using separate instruments.

[0125] The planning steps may include at least one of the following: (i) defining the puncture location and / or access point; (ii) defining the access route; and (iii) defining at least one of the implant valve type, the implant location within the aortic valve, and the implant valve size.

[0126] Typically, it is necessary to specify a combination of the type of implantable valve of the appropriate size, its intended location within the natural aortic valve, a suitable access point, and a suitable route from the access point to the intended location within the aortic valve. Each planning step may be entered by the user, selected by the user from a list stored in the system, defined by the computing unit, and / or modified by the user.

[0127] The robot motion step may include at least one of detecting an access patch and / or access point, and moving a surgical robot, in particular a surgical tool mounted thereon, to the access point or access patch.

[0128] The robot motion steps may be automatically guided by the computing unit. The user may change the access point, position, and orientation of the surgical robot at any point before or during the robot motion steps.

[0129] The puncture step may include at least one of detecting an artery, targeting the needle, positioning the needle, i.e., puncturing it, positioning an introducer, and positioning a dilator. Needle targeting may be, for example, branch-based.

[0130] Before moving the needle inside the patient's body, the system may position and reorient the needle tip according to a target point inside the patient, such as an arterial bifurcation.

[0131] Since the needle can be positioned and oriented outside the human body, access can be performed simply by moving the needle along the longitudinal direction of its shaft.

[0132] The navigation step may include moving the implant valve from the access point to the target position. The navigation step may include positioning a guidewire, introducing the valve into the artery, detecting certain anatomical features such as thin vessel walls, vascular bifurcation, vascular bulging, or calcification, determining parameters for valve movement according to the anatomical features, e.g., slowing movement within the aortic arch, or, if necessary, selecting specific tools for advancement, e.g., a balloon to widen the vessel, and moving the valve along the guidewire according to the parameters.

[0133] Before or during each navigation step, the computing unit may request a validation instruction before proceeding.

[0134] Navigation steps may include widening calcified vessels or widening congenital valves.

[0135] The intermediate step may include passing the implanted valve through the natural valve. This step may require additional verification instructions in addition to other verifications.

[0136] The valve placement step may include moving the implant valve within the natural valve, holding the implant valve in a selected position, deploying the implant valve, and checking the function of the deployed implant valve.

[0137] During the movement of the implant valve, the path may be modified by the operator or based on suggestions from the computing unit.

[0138] The deployment of the implant valve may include releasing and opening the implant valve. The pressure of the deployment balloon may be adjusted during the deployment step.

[0139] The function of the deployed implant valve may be tested by detecting a pressure gradient along the implant valve or by imaging the valve in the presence of a contrast agent. The amount of contrast agent may be adjusted during the step.

[0140] The output device may emit acoustic and / or visual signals, such as beeps, voice signals, or LED signals, during navigation to assist user-guided positioning, particularly during arterial access, valve passage, or placement.

[0141] Each step or at least one step of the valve placement process may be guided by the user, controlled by a computing unit, and / or modified by the user.

[0142] Verification commands entered by the operator may be required to ensure that the implant valve is correctly positioned and secured.

[0143] The closure step may include removing the surgical tool, closing the artery, and checking whether the artery is properly closed, for example, via ultrasound imaging or fluoroscopy.

[0144] Each step or at least one step of the closing process may be guided by the user, controlled by the computing unit, and / or adapted by the user.

[0145] The system may also be adapted for transcatheter valve implantation procedures, particularly for heart valves other than the aortic valve. In this case, the steps of the medical procedure may include the same or similar steps as those of a TAVI procedure employed for a particular valve.

[0146] Alternatively, the system may be adapted to an obesity procedure. In this case, the steps of the medical procedure may include at least one of the following: an obesity preoperative planning step, an obesity navigation step, an obesity volume measurement step, an obesity gastric reduction step, an obesity safety check step, an obesity volume verification step, an obesity implant seating step, and an obesity retraction step. Each obesity procedure step may include substeps.

[0147] Bariatric surgery generally refers to surgical procedures that attempt to reduce the weight of severely overweight patients. Procedures in such context include sleeve gastrectomy and / or the use of implants such as gastric bypasses or gastric bands. In this application, bariatric procedures may specifically refer to oral placements on endoscopic gastrointestinal bypass devices, gastric balloons, gastric stimulators, duodenal sleeves, or anastomotic devices. The bypass device may be a cuff attached to the distal esophagus by transwall anchors and connected to a 120 cm sleeve that diverts undigested nutrients into the jejunum.

[0148] The procedure for obesity may also refer to "sleeve gastroplasty," in which the volume of the stomach is endoscopically reduced by the application of sutures, staples, or anchors.

[0149] In the obesity gastric volume measurement step, the total volume may be detected first. In the obesity gastric reduction step, sutures, staples, or anchors may be applied.

[0150] In the obesity safety check step, suture depth, suture location, and / or suture strength may be detected and compared to at least one predetermined specification. It may be determined whether the suture depth, suture location, and / or suture strength conform to at least one predetermined criterion.

[0151] In the obesity volume verification step, it is possible to detect whether or not the intended final volume has been achieved.

[0152] The pre-obesity planning step may preferably include defining gastric volume reduction, type of obesity procedure, implant size, particularly length, further obesity procedure steps, navigation routes, checkpoints, deployment sites, or initial positioning of the surgical robot, using a virtual "standard" patient.

[0153] The user interface allows the operator to select the type of obesity treatment; for example, they can plan for gastric sleeve placement or gastric volume reduction.

[0154] A virtual patient may be created based on the patient's morphology, which may be determined by the imaging method and / or prior measurements.

[0155] The obesity navigation steps may include moving the implant to a target position, introducing the tool and / or implant into the gastrointestinal tract, detecting specific anatomical features and setting parameters for implant movement according to those anatomical features, such as slowing movement during passage through the sphincter, and moving the implant according to those parameters.

[0156] Obesity navigation steps may include controlling the path toward the stomach and the correct route within the stomach, passing through the pharynx, passing through the sphincter, and / or reaching the target location.

[0157] The output device may emit acoustic and / or visual signals, such as beeps, voice signals, or LED signals, during navigation to assist user-guided positioning.

[0158] While passing through the pharynx and / or sphincter, the force of the deployment tool may be applied.

[0159] As the implant passes through the pharynx, the computing unit can generate signals that are sent to the user interface and / or output interface, thereby prompting the patient to swallow.

[0160] The obesity navigation step may include, for example, imaging the process of inserting an implant in 3D model reconstruction.

[0161] Obesity navigation steps may be performed autonomously. The obesity implant seating step may include positioning the implant at its final location within the digestive tract, deploying the implant, particularly securing the implant, and spreading the implant.

[0162] While seated, the operator may adjust the position and orientation of the implant, and preferably adjust the pressure of the inflatable anchor, for example, based on sensors on the device and / or on the delivery system, such as pressure sensors and force sensors.

[0163] The steps to reduce obesity may include removing tools. Each step or at least one step of the obesity procedure may be guided by the user, controlled or assisted by a computing unit, or modified by the user.

[0164] A verification command may be requested after or during each step or a single step. The system may include imaging tools such as an endoscope camera and / or any other measuring devices for live measurements of the stomach to monitor all obesity steps. Imaging tools may include an endoscope camera, stereo camera, narrowband imaging device and / or ultrasound imaging device.

[0165] Live measurements may be based on real-time stereo reconstruction, or a laser / light source may be used to project a pattern onto the stomach wall to assist in stereo 3D reconstruction.

[0166] Image tools can show digestive processes before or during obesity procedures, such as the pathway food takes, on live video.

[0167] Alternatively, the system may be adapted to a bronchoalveolar procedure similar to the obesity procedure described above. In this case, the steps of the medical procedure may include at least one of the following: a bronchoalveolar pre-planning step, a bronchoalveolar navigation step, a bronchoalveolar volume measurement step, a bronchoalveolar safety check step, a bronchoalveolar volume verification step, a bronchoalveolar implant placement step, and a bronchoalveolar retraction step. Each bronchoalveolar procedure step may include substeps.

[0168] Alternatively, the system may be adapted to a ureteral bladder procedure similar to the obesity procedure described above. In this case, the steps of the medical procedure may include at least one of the following: a ureteral bladder pre-planning step, a ureteral bladder navigation step, a ureteral bladder volume measurement step, a ureteral bladder safety check step, a ureteral bladder volume verification step, a ureteral bladder implant placement step, and a ureteral bladder retraction step. Each ureteral bladder procedure step may include substeps.

[0169] Alternatively, the system may be adapted to a vaginal-uterine procedure similar to the obesity procedure described above. In this case, the steps of the medical procedure may include at least one of the following: a pre-vaginal-uterine planning step, a vaginal-uterine navigation step, a vaginal-uterine volume measurement step, a vaginal-uterine safety check step, a vaginal-uterine volume verification step, a vaginal-uterine implant placement step, and a vaginal-uterine retraction step. Each vaginal-uterine procedure step may include substeps.

[0170] The computing unit may be adapted to determine risk parameters associated with a change based on change instructions input via the change interface. The computing unit may be further adapted to provide risk parameters or, depending on the risk parameters, request verification instructions such as further change instructions or go / no-go instructions. The computing unit may be further adapted to provide warning signals, preferably optical or audible warning signals, depending on the risk parameters. In any case, each signal is transmitted to an output interface.

[0171] The risk parameters may be selected from a predetermined risk category, for example, a predetermined risk level, and / or the risk parameters may be associated with a set of consequences resulting from a change command, such as failure of a medical procedure step or harm to the patient.

[0172] The system may include at least one separate emergency stop device. The separate emergency stop device may be configured to be located near the patient and / or near the computing unit and / or near the surgical robot so that the user can immediately respond to an unexpected event.

[0173] A separate emergency stop device may be integrated into the user interface, for example, as a separate button or as a control area displayed on a monitor. Preferably, the separate emergency stop device is provided as a separate physical unit.

[0174] Preferably, a separate emergency stop device is provided in addition to the stop interface. The system may include an output interface for providing the user with information, in particular, regarding at least one of the steps described above.

[0175] The output interface may be adapted to receive signals from a computing unit, preferably from a unit separate from the system, such as a sensor device.

[0176] The output interface may include visual and / or acoustic units. The visual unit may display optical signals, text, images, film, and / or holographic information. The output unit may also be part of the user interface.

[0177] The output interface may be selected from the group consisting of optical or visual output interfaces, augmented reality displays, virtual reality displays, haptic feedback devices, or acoustic output interfaces.

[0178] The optical or visual output interface may include light emitters such as LED lights or monitors, or projectors, particularly for projecting information, such as photographs or films, onto a patient's body, or for providing a 3D monitor, such as a holographic projector. The optical or visual output interface may also include VR goggles.

[0179] The output interface may be a combination of a 3D monitor and a haptic feedback device such as a haptic glove.

[0180] The output interface may be capable of receiving user input, which can be associated with the displayed information. For example, the output device may be a combination of a hologram display device and a tactile glove, allowing the user to rotate and shift the hologram.

[0181] The output interface may support the user providing their own input. For example, the user may change the path by moving along an animated path presented by the output interface.

[0182] The acoustic output interface may provide an acoustic alarm signal or may include a speech synthesizer.

[0183] The output interface may also be part of the user interface. The computing unit may be adapted to generate signals and transmit them to an output interface.

[0184] The computing unit has an output interface, - Information about the current step being performed by the system and / or the next step that should be performed by the system. - Intervention steps, preferably a checklist including all intervention steps, - Information regarding digital twins, - Information about simulated procedures, - Information about the patient's landmarks, - Information regarding the target area of ​​the needle, - Information regarding the planned and / or actual trajectory of the implant, - Information regarding the passage of the implant in a specified area, - Information regarding important areas and / or important steps, - Information regarding planned and / or actual equipment installations, - Information regarding the patient's physiological parameters and / or environmental data, - Information about the requested input and / or actions It may be adapted to provide information selected from a group consisting of the following:

[0185] Information about the current step and / or next step performed by the system can provide the operator and / or patient with feedback on the stage of the procedure.

[0186] For example, the computing unit may be adapted to provide an output interface with information about a tool or implant to reach the area of ​​interest, such as the annulus or sphincter, indicating that the system is ready for the next procedural step. Information about the current and / or next steps may mean a request for one of the preceding control commands.

[0187] The computing unit may be adapted to provide information on past or planned steps of a medical procedure to facilitate procedure planning, generate reports, and / or predict possible next steps.

[0188] The computing unit may generate reports or assist in generating reports.

[0189] Information regarding the current step and / or the next step can be provided using a detailed checklist that can be automatically updated in manual mode or manually in degraded mode.

[0190] Regardless of the operating mode, the computing unit may be adapted to provide information to the output interface in the form of a checklist containing the steps of intervention, preferably all intervention steps. The system may display the checklist.

[0191] The checklist may be editable during the planning process. Generally, checklists track equipment and their locations.

[0192] In autonomous mode, the checklist may inform the surgeon which comprehensive (intervention) step will be performed (e.g., access), which step has been verified, and which substeps within that step will be performed and will be performed (e.g., needle puncture, dilator insertion, introducer insertion, dilator removal, needle removal, etc.).

[0193] In degenerate mode, the checklist may remind the clinician which instruments need to be deployed and which procedures need to be performed. Additionally, the checklist may allow for tracking of what has already happened.

[0194] Manual updates and / or edits can be performed via input interfaces, such as the user interface, the change interface, or the validation interface, as described above.

[0195] The virtual twin may include a virtual representation of the patient's target anatomical structures to aid in planning and intraoperative decision-making. The virtual twin may be presented as a two-dimensional image or as a reconstructed three-dimensional model. The virtual twin may include specific anatomical characteristics of the patient, such as calcifications. The virtual twin may also include specific landmarks selected by the user or determined and configured by the computing unit.

[0196] The simulated procedure may include information about critical steps of the medical procedure and critical areas of the patient that require greater attention from the operator, or the simulated procedure may represent critical phases and critical areas.

[0197] The computing unit may provide data on patient images, particularly landmarks on ultrasound images. Landmarks can help in fusing images from different sources and / or planning further steps.

[0198] The computing unit may suggest a target area for needle insertion based on a patch set by the user, and / or based on the patient's anatomical structure, and / or based on the steps of the medical procedure.

[0199] The implant trajectory describes the path the implant takes between the access site and the target site. The trajectory may be presented on a patient image, for example, on a virtual twin. The trajectory may be visualized from different viewpoints, for example, from the outside or from the tip of the instrument. The trajectory may be visualized in a two-dimensional or three-dimensional representation.

[0200] Information regarding the passage of the implant in a given region may include a detailed description of that region, which may allow for the planning and / or monitoring of procedural steps in that region, such as valve passage.

[0201] Critical steps in medical procedures and critical areas of a patient may be associated with higher risk levels and may require a higher level of care. Critical areas may include specific patient characteristics such as vascular calcification, thin vessel walls, or vascular bulging. Critical procedural steps may involve difficult manipulations and / or complex tool handling.

[0202] Patient parameters may include measured physiological parameters such as blood pressure, body temperature, blood flow profile, or pulsed oxygen saturation. Patient parameters may also include live measurements of the stomach. Parameters may be determined by a computing unit based on information provided by sensors.

[0203] Environmental data may include data measured outside the patient, such as temperature, ventilation parameters, or treatment parameters like balloon pressure.

[0204] Information regarding critical events may include, for example, warning signals displayed in the event of unplanned events such as a deterioration in a patient's vital signs, a system failure, or unexpected movement by a patient.

[0205] Each piece of information may be calculated by a computing unit, and / or obtained from stored data, and / or entered by an operator.

[0206] Information regarding the requested input and / or action may include an invitation to give stop, change, or continue commands, such as a simple go / no-go input, or a suggestion to change the level of autonomy.

[0207] Information regarding the requested action may include suggestions for interaction with the patient, such as requests for the patient to swallow or breathe.

[0208] The computing unit may be adapted to process user instructions, in particular to modify instructions, calculate possible outcomes, predict the impact on, for example, further procedure steps and / or further procedure steps, and evaluate each instruction and / or its respective outcome. The computing unit may be adapted to transmit the calculated results to an output interface, in particular to show the operator which risks are associated with each instruction.

[0209] The output interface may provide animated 2D or 3D presentations, preferably from different viewpoints, which may give the user the possibility to interact with them, for example, to set landmarks for highlighting areas of interest.

[0210] In animated 2D or 3D presentations, pathway and / or forward tools and / or tools during actions can be displayed in relation to the patient's image.

[0211] The computing unit and / or output interface may combine information from different sources, for example, by overlaying calculated or input data with ultrasound or X-ray images.

[0212] The computing unit may be adapted to change its level of autonomy, in particular to autonomously switch to a lower level of autonomy, and / or to propose a change to a higher level of autonomy.

[0213] The system may include at least one actuator. The system may include at least one medical tool that is operablely connected to an actuator. The tool is, in particular, -puncture needle, - Expander, - Introducer, - Guide wire, - Preferably a catheter having a pre-attached implant, - Endoscopic devices, especially growth robots, - Imaging device, and - Closed unit It is selected from the group consisting of the following.

[0214] The dilator may include a balloon for widening blood vessels, natural valves, implants, and / or shaping them.

[0215] The closure unit may include a suturing device. The system may include at least one actuator for operating a surgical robot. The system may include at least one surgical robot.

[0216] The system may include a sensor interface for communicating with at least one imaging device, such as a camera, endoscope, ultrasound device, MRT device, or X-ray device.

[0217] The system may be connected to, or can be connected to, an imaging device via a sensor interface.

[0218] The system may include an imaging device, particularly an imaging device that is part of or attached to a surgical robot.

[0219] The system may use imaging device data during steps of an automatically performed procedure, such as finding a location to position the surgical robot relative to a table or patient, finding a labeled location on the patient, such as a puncture site, or determining the puncture direction based on arterial ultrasound data.

[0220] The system may include an operating unit with a user interface and a computer unit, and / or a mobile robot cart for transporting the surgical robot. The computer unit may be adapted to control the mobile robot cart. The mobile robot cart may have a separate control unit that enables it to be driven. The mobile cart may follow the operator to the operating room.

[0221] Surgical robots, particularly mobile carts, may be in "on" mode, "off" mode, or "standby" mode. In "standby" mode, the surgical robot may be moved manually. The computing unit may be adapted to switch between "on" mode, "off" mode, or "standby" mode.

[0222] The present invention also provides a method for autonomously performing at least one step of a medical procedure comprising at least one step.

[0223] This method is preferably carried out using the system described above. The method includes the step of autonomously controlling the operation of an actuator by a computing unit to operate a surgical robot to perform at least one step of a medical procedure.

[0224] This method further includes the computing unit receiving control instructions from the user interface in one of the following forms: change instructions, stop instructions, and continue instructions.

[0225] This method further includes using a computing unit to induce a change operation, deceleration operation, acceleration operation, holding operation, stopping operation, or continuous operation of an actuator based on the control commands described above.

[0226] A medical procedure may be divided into multiple separate steps, and the method may include automatically requesting the input of the control commands before, during, and / or after at least one of the steps.

[0227] If a medical procedure is divided into multiple separate steps, the computing unit can operate in autonomous mode and have complete control over the operation of actuators to perform at least one step of the medical procedure.

[0228] Additionally or alternatively, the computing unit may operate in a fully degraded mode. The fully degraded mode may also be a manual degraded mode, where the computing unit releases the actuator for at least one step of a medical procedure. The fully degraded mode may also be a remotely controlled degraded mode, where the computer unit controls the actuator for at least one step of a medical procedure based on remote operator control commands provided by the user.

[0229] Additionally or alternatively, the computing unit may operate in a partially degenerate mode, where the computing unit controls the operation of an actuator to perform at least one step of a medical procedure based on communication with the user.

[0230] As described above, the partial degeneration mode may include different levels of partial degeneration mode depending on the degree of user impact on the computing unit.

[0231] This method may include switching between autonomous mode, fully degenerate mode, and / or partially degenerate mode.

[0232] Switching between different levels of partial degeneracy mode is also possible. The computer unit may automatically switch from autonomous mode to partially degenerate mode and / or fully degenerate mode, or from partially degenerate mode to fully degenerate mode. In this context, "automatically" means that in each mode, the computer unit verifies whether the conditions for continuing to operate in that mode are met. If not, the computer unit switches to a less autonomous mode on its own.

[0233] This method may include switching modes according to a predetermined hierarchical model. In particular, the computer may switch to only the next nearest level of autonomy. The computer unit may automatically switch to a less autonomous mode, and the computer unit may require a control command from the user to switch to a more autonomous mode.

[0234] In particular, transitions from one level to another may occur autonomously only, after an intervention step has been performed, from a fully autonomous level to a semi-autonomous level. The system then awaits human input to validate and initiate the next intervention step. Returning from a semi-autonomous level to a fully autonomous level can only be done after human input.

[0235] Transitions from all other levels to the neighborhood level are preferably performed solely by human input.

[0236] In the absence of an emergency, the computer may switch to the nearest lower level of autonomy and wait for input / commands. Preferably, the computer cannot switch to a higher level of autonomy on its own.

[0237] Preferably, a human user can activate emergency mode at any time in any mode.

[0238] For safety reasons, the system may be capable of detecting and signaling anomalies that constitute an emergency, in which case it may pause and await orders or direct human intervention.

[0239] The computer unit may request control commands from the user before switching to autonomous mode or before switching from fully degraded mode to partially degraded mode. Therefore, preferably, the computer unit switches to a more autonomous mode only when permitted by the user.

[0240] The computing unit may receive control commands relating to at least one of a checklist and / or to-do list, including an access point for entering the patient's body, the position of the surgical robot relative to the access point for entering the patient's body, the implant position, the speed and trajectory of implant insertion, the position and / or orientation of the implant, deployment parameters for deploying the implant, in particular balloon pressure for expanding the implant, the orientation and speed of the imaging device, in particular the instrument retraction and operation of the endoscopic camera, and steps of intervention.

[0241] Control commands may include detailed information and may be used directly to control the actuator. Control commands may also cause the computer unit to determine the respective data for controlling the actuator. The user may specify access points, surgical robot positions, implant locations, etc., or the computer unit may be adapted to determine and / or change access points, surgical robot positions, implant locations, etc.

[0242] This method may be adapted for intraluminal procedures. Generally, a computer unit may plan and / or perform at least one step of a medical procedure. To plan and perform the step, the computer unit may use AI software.

[0243] The computing unit may receive data, for example, regarding the patient's anatomical structure and condition, technical options, and environmental conditions. In particular, based on this data, it may determine parameters for controlling steps in a medical procedure and control a surgical robot based on the determined parameters. The computing unit may provide intermediate results, report on the steps in progress to the user, and request confirmation.

[0244] This method may be adapted to intraluminal procedures that involve body tubules or body cavities, such as TAVI procedures, obesity procedures, bronchoalveolar procedures, ureteral bladder procedures, or vaginal uterine procedures.

[0245] The computing unit can control at least one of the following steps, as described above: preoperative steps, planning steps, robotic motion steps, navigation steps for moving the valve from the access point to the target position, intermediate steps, valve placement steps, and closure steps.

[0246] This method may also be adapted to an obesity procedure, in which the computing unit can control at least one of the following steps: the obesity pre-planning step, the obesity robot positioning step, the obesity navigation step, the obesity implant seating step, the obesity implant deployment step, and the obesity retraction step, as described above.

[0247] This method may also be adapted to a bronchoalveolar procedure, in which the computing unit can control at least one of the following steps: a bronchoalveolar pre-planning step, a bronchoalveolar robot positioning step, a bronchoalveolar navigation step, a bronchoalveolar implant placement step, a bronchoalveolar implant deployment step, and a bronchoalveolar retraction step, similar to those of the obesity procedure described above.

[0248] This method may also be adapted to a ureteral bladder procedure, in which the computing unit can control at least one of the following steps: a pre-ureteral bladder planning step, a ureteral bladder robot positioning step, a ureteral bladder navigation step, a ureteral bladder implant seating step, a ureteral bladder implant deployment step, and a ureteral bladder retraction step, similar to those of the obesity procedure described above.

[0249] This method may also be adapted to a vaginal-uterine procedure, in which the computing unit can control at least one of the following steps: a pre-vaginal-uterine planning step, a vaginal-uterine robot positioning step, a vaginal-uterine navigation step, a vaginal-uterine implant seating step, a vaginal-uterine implant deployment step, and a retraction step, similar to those of the obesity procedure described above.

[0250] The computing unit may determine risk parameters associated with a change based on change instructions entered via the change interface. The computing unit may compare the risk parameters to a predetermined risk category, such as a risk level, and respond accordingly. For example, if the risk is too high, the computing unit may request confirmation and / or a new control instruction, and / or stop the operation of the actuator, and / or switch to a lower level of autonomy.

[0251] The computing unit may receive user input and / or user changes, calculate the next step based on the user input, and transmit the results of the calculation to the output interface. The computing unit may also assess the risks associated with the results, and the output device may display the results with the associated risks.

[0252] As described above, the computing unit may provide the output interface with information selected from a group consisting of information about the current step performed by the system and / or the next step to be performed by the system, information about checklists and / or to-do lists, information about the digital twin, information about the simulated procedure, information about landmarks on the patient image, information about the target area of ​​the needle, information about the planned and / or actual trajectory of the implant, information about the passage of the implant in a given area, information about critical areas, information about planned or actual instrument retraction, as well as information about the patient's physiological and / or pathological parameters, as well as / or environmental data, and information about requested inputs and / or actions.

[0253] The information provided to the output interface may preferably inform the user about all actions performed by the robot in the live view, all actions performed following the current step, and / or all steps that have been performed.

[0254] The output unit may provide a final report on the medical procedure, indicate which steps had what level of autonomy, and / or provide an evaluation of the steps performed.

[0255] The computing unit can control at least one medical tool that is operablely connected to an actuator, selected from in particular a puncture needle, dilator, introducer, guidewire, catheter, preferably with a pre-attached implant, imaging device, endoscope, and especially a growth robot and closure unit. For example, as disclosed in EP4066724A1, a growth robot moves and interacts with the environment using an extension of the robot body.

[0256] The present invention also provides a computer program which includes program code for performing the steps of the method described above when the program is executed on a computer, the program code preferably using a pre-trained neural network and / or artificial intelligence software.

[0257] The present invention also provides a computer program product which includes a portion of software code that can be loaded directly into the internal memory of a digital computer and which performs the method steps described above when the program is running on the computer, preferably the software code is adapted to access pre-trained neural networks and / or artificial intelligence software.

[0258] The present invention will be better understood by referring to the following description of preferred embodiments and the accompanying drawings. [Brief explanation of the drawing]

[0259] [Figure 1] This is a schematic diagram of a first embodiment of the system according to the present invention. [Figure 2] This is a schematic diagram showing examples of system components and their connections. [Figure 3] This is a schematic diagram of a second embodiment of the system according to the present invention. [Figure 4] This is a schematic diagram showing the steps of the TAVI procedure. [Figure 5] This is a schematic flowchart showing the substeps of the robot motion step and the puncture step. [Figure 6] This is a schematic flowchart showing the detailed substeps of the robot motion steps. [Figure 7] This is a schematic diagram illustrating a hierarchical model of different modes. [Modes for carrying out the invention]

[0260] Figure 1 is a schematic diagram of a first embodiment of System 1 for autonomously performing a medical procedure comprising at least one step. System 1 comprises a user interface 2 for inputting user commands, a computing unit 3, and an interface 4 for communicating with at least one actuator 5 to operate a surgical robot 6. The computing unit 3 is adapted to autonomously control the operation of the actuator 5 to perform at least one step of a medical procedure.

[0261] The computing unit 3 receives control commands in the form of change commands, stop commands, and continue commands from the user interface 2 and adapts them to trigger change, stop, or continue operations of the actuator 5 based on the control commands.

[0262] Actuator 5 enables the operation of different medical tools 10 associated with the surgical robot 6. Interface 4 works with actuator 5 via wire connections 16 to transmit control signals to the surgical robot 6 and receive signals that can be processed by the computing unit 3. For example, the computing unit 3 may generate signals to be displayed on the display of the user interface 2.

[0263] System 1 includes a memory 3a that can store information about the procedure steps, information about the risk levels associated with the procedure steps, and information about the patient, such as data related to the patient's anatomical structure.

[0264] Figure 2 is a schematic diagram showing an example of system components and their connections. System 1 may include a UI (user interface) laptop connected via USB to a gamepad and a LOG camera. This UI laptop and a US (ultrasound) laptop coupled to a US (ultrasound) beamformer via USB are connected to a central router via Ethernet.

[0265] UI laptops and gamepads can be used to function as a user interface for inputting user commands and as a display for monitoring medical procedure steps.

[0266] The router may also be connected to a switch via Ethernet, which may be connected via Eth2USB, associated with a robot controller connected by USB, and a mini PC, in this case a NUC, via Ethernet. There may also be an Ethernet connection between the mini PC and the robot controller.

[0267] The mini PC may be connected via USB to an access subsystem including load cells, sensors, and motor controllers. Additionally, the mini PC may be connected to a fixed camera and / or a mounted camera.

[0268] The mini PC and robot controller may act as a computing unit adapted to autonomously control the operation of actuators so that the robot can perform at least one step of a medical procedure.

[0269] Figure 3 is a schematic diagram of a second embodiment of System 1. The system comprises an operating unit 12 having a computer 11. The computer 11 includes a computing unit (not explicitly shown) and a monitor 13 that provides a user interface 2 and an output interface 9.

[0270] The computer 11 includes a verification interface 2a having an eye-tracker and a modification interface 2b, in this case a remote control console including a joystick, buttons, and a hand movement tracker.

[0271] System 1 further comprises a surgical robot 6 having a robotic arm 14 that communicates with a computer 11. The surgical robot 6 is equipped with an emergency stop device 8 for immediately stopping any surgical procedure when an emergency stop button is activated.

[0272] The surgical robot 6 is equipped with a mobile robot cart 15 that autonomously moves the surgical robot 6 to the surgical site.

[0273] Figure 4 is a schematic diagram showing the steps of the TAVI procedure. The TAVI procedure includes a preoperative step 21, a planning step 22, a robotic motion step 23, an access step 24, a navigation step 25, an intermediate step 26, a valve placement step 27, and a closure step 28.

[0274] During preoperative step 21, based on the imaging process, three-dimensional images of the relevant vascular system are reconstructed, and, for example, computed tomography with contrast agent and / or vascular mapping are generated.

[0275] A digital twin of the patient may be created. The digital twin may be displayed. During planning step 22, the puncture location and / or access point is determined. The computing unit proposes a route through the vascular system, implant valve type, implant valve size, and specific implant valve position. The operator may validate each proposal or change their selection. The computing unit may check the results of the manual selection. The computing unit may then validate the selection or return warnings or alternative suggestions.

[0276] During robot movement step 23, the surgical robot 6, particularly the robot arm 14 (see FIG. 2), is moved to the location and orientation for performing the surgical procedure, as disclosed, for example, in EP22315330.5.

[0277] To transport the surgical robot 6 to the operating location, an access patch can be detected, and the mobile robot cart 15 can position the surgical robot 6 such that the robot arm 14 can reach the access patch.

[0278] During access step 24, the artery is detected, an appropriate needle is selected, the needle is placed, and the patient is punctured. Then, the introducer is placed at the access point, optionally by using a dilator.

[0279] For example, when the femoral branch of the artery is detected, the needle target may ideally be about 1 - 2 cm before the branch where the amount of calcification is minimal.

[0280] Actions on the patient are performed by the robot arm 14 under the control of the computing unit 3. The computing unit 3 may autonomously plan and perform all sub - steps of the puncture step, being induced by the user or being verified for validity by the user. During navigation step 25, a guide wire is laid from the access point through the vascular system to the heart. The implant valve is guided through the introducer and from the access point to the heart along the guide wire. Additional tools are used as needed. For example, if a calcified structure is detected, a balloon may be used to expand the blood vessel.

[0281] The computing unit 3 may autonomously plan and perform all sub - steps of navigation step 25, being induced by the user or being verified for validity by the user.

[0282] In certain anatomical structures, the user may take complete control, or their influence may be increased. For example, when passing through the aortic arch, control commands may be required at additional checkpoints. The speed of movement may be reduced to give the user further opportunities for intervention.

[0283] During the intermediate step 26, the valve implant passes through the natural valve. This step typically requires high operator attention and can be controlled with a low level of autonomy from the computing unit 3, for example, in fully degenerate or partially degenerate mode.

[0284] In some cases, it may be necessary to widen the calcified congenital valve. During valve placement step 27, the valve implant is transitioned to its functional state. The valve implant is properly positioned, deployed from the catheter, oriented, expanded, secured, and / or partially or completely released from the catheter. The validity of the valve's function is verified by measuring the pressure gradient and / or by monitoring the flow of contrast agent.

[0285] If necessary, the valve implant may be recaptured, reloaded into the catheter, repositioned, or removed.

[0286] The computing unit 3 may be guided or validated by the user and autonomously plan and execute all substeps of the valve placement step 27.

[0287] Navigation step 25, intermediate step 26, and valve placement step 27 are typically monitored by an imaging system, such as an X-ray system. Additionally or alternatively, local information detected by the robotic arm may be converted into signals presented on an output device, for example, on 3D images of the patient and / or a digital twin and / or on a virtual reality monitor.

[0288] During closure step 28, all instruments are removed from the vascular system. The artery is preferably closed using a closure device. The closure is validated, for example, using fluoroscopy and / or ultrasound.

[0289] Each step, preferably each substep, may first be related to a predetermined autonomous mode.

[0290] Figure 5 is a schematic flowchart showing the substeps of robot motion step 23 and access step 24. The substeps may begin when the surgical robot has taken its intended position.

[0291] In step 101, the system checks whether it is in a ready state. The user may verify the validity of the ready state.

[0292] In step 102, the robot arm is configured for home use. The user may verify the validity of the home configuration.

[0293] In step 103, the patch search is performed according to a patch search termination condition that defines, for example, at least one patch must be found, as disclosed in EP22315330.5.

[0294] To search for a patch, the movement step 104 can be repeated, and the robotic arm having the patch detection unit moves several times until at least one patch is detected.

[0295] As soon as a patch is detected, in step 105, a route is defined for moving the access tool to the access point. Until the final route is determined, other routes may be planned in step 106, for example, unless the validity of the final route has been verified by the user.

[0296] In step 107, the path is executed, which means that the tool is positioned above the patch.

[0297] In step 108, the tool is moved towards the patient until it contacts the patch.

[0298] In step 109, a search is performed by an ultrasonic probe to scan the skin until the axial position of the artery is detected.

[0299] In step 110, the center of the artery can be manually input. Alternatively or additionally, in step 111, the search may be repeated.

[0300] In step 112, the skin is scanned along the axis of the artery towards the branch until the branch is detected. If necessary, in step 113, the center of the branch is manually input.

[0301] In step 114, a 90° rotation of the ultrasonic probe is performed about the US probe shaft so as to pass from the axial view of the blood vessel to the longitudinal view until the branch is detected longitudinally.

[0302] In step 115, a needle access is identified. The needle access may be identified as a function of the thigh branch position and / or the femoral head position.

[0303] The puncture can be based only on the position of the thigh branch, or on the position of the femoral head, or a combination of both may be possible for more algorithmic robustness and patient safety.

[0304] The position of the branch or the femoral head can be identified purely by an image processing algorithm, purely by a deep neural network, or by combining both methods.

[0305] An example of a purely image processing algorithm for detecting femoral bifurcation may include the following steps:

[0306] Firstly, the femoral artery around the femoral bifurcation region is segmented, for example, using an active contouring method.

[0307] Secondly, the midline (or skeleton) of the femoral artery is extracted, for example, by using mathematical morphology, and the medial contour of the femoral artery is identified using mathematical rules regarding the position of the medial contour relative to the midline of the femoral artery.

[0308] Next, the medial contour of the femoral artery can be approximately modeled as an inclined Y-shape, for example, by using mathematical morphological rules, so that the femoral bifurcation can be directly extracted as a Y-shaped branching point.

[0309] A combination of deep neural networks and image processing for detecting femoral bifurcation could include, for example, using a deep neural network (e.g., 2D UNet) to segment the femoral artery around the femoral bifurcation region.

[0310] Subsequently, the femoral bifurcation can be extracted by the subsequent image processing steps described above. A pure deep neural network based on femoral artery bifurcation detection may include training a regressive deep neural network on images labeled by a medical professional to directly identify the geometric coordinates of bifurcation points in ultrasound images.

[0311] Image processing algorithms for femoral head detection in ultrasound images may include, for example, adaptive thresholding or clustering algorithms in the vicinity of pixels (e.g., K-means), as well as detecting zones of the femoral head with enhanced texture using prior knowledge of femoral head shape (e.g., roundness) and relative position to arteries and / or femoral bifurcations.

[0312] Neural network-based detection of the femoral head may involve training a segmented deep neural network (e.g., 2D UNet) trained on a significantly large dataset of labeled images. Alternatively, a parametric shape model (e.g., elliptic or higher-order shape) may be fitted to the femoral head using a regressive deep neural network with prior knowledge of the femoral head's shape. The latter takes ultrasound images as input and outputs a vector of parameters for the selected parametric shape model.

[0313] If necessary, needle access is manually identified in step 116. For example, branching may be detected, as shown in the concurrently pending application EP22315210.9 of the same applicant.

[0314] As soon as needle access is identified, in step 117, the needle is moved toward the target.

[0315] In the subsequent step 118, the needle is moved until it is inserted. In step 119, the introducer is inserted. As soon as the validity of the introducer's proper insertion is verified, the tool can be removed in step 120.

[0316] In the final step 121, the puncture tool may be configured for home use. Throughout all substeps, the operator is positioned to stop, verify, edit, and / or intervene at any given step. Interactions occur via user interfaces 2, such as graphical user interfaces (GUIs), virtual reality environments, physical buttons, voice generators, eye-tracking devices, and haptic gloves.

[0317] Figure 6 is a schematic flowchart showing further substeps of the robot motion steps. These further steps include an exit point in case the next substep could not be performed.

[0318] For example, after steps 104-107 (see also Figure 5) are performed, and the patch is detected, the path is planned, and the robotic arm moves above the patch, it may be found that the patch is lost and can no longer be detected. If the patch is lost, steps 104-107 must be repeated.

[0319] If the patch is not lost, you can proceed to step 108 and move the tool towards the patch.

[0320] Again, it may be found that the patch is lost and can no longer be detected. If the patch is lost at this point, steps 104-108 must be repeated. Otherwise, the pass may be executed.

[0321] If you can no longer find the patch, you will need to move the tool away from the skin.

[0322] Movement outward from the skin may include movement within Cartesian space along the direction of the principal axis in the case of an ultrasound probe. This ensures linear motion of the ultrasound probe away from the patient.

[0323] As soon as it comes into contact with the patient's skin, the patch detection module ceases to function. Figure 7 schematically shows the hierarchical models for different modes.

[0324] Mode IV accommodates the lowest level of automation, and the computer unit is only suitable for signal processing under human control.

[0325] Mode IV corresponds to Level 0, as described above. The system, for example, the system of a surgical robot, does not complete any steps, but some subsystems may continue to perform tasks such as signal processing.

[0326] This mode can be activated during emergencies. Mode III is associated with degenerate autonomy. The user can directly control the physical device.

[0327] Mode III corresponds to levels 1-2 as described above. The surgeon physically designates the surgical robot to be positioned and / or moved to the region of interest, either remotely or through interaction, and the surgical robot can then complete a series of steps. Positioning may be enabled by overlaid ultrasound images, such as detected blood vessels or other anatomical features.

[0328] Mode II refers to a semi-autonomous level in which the agent is powered by GUI input. Mode II corresponds to Level 3 as described above. The surgical robot may have a general plan of what will be done and / or what will be achieved or detected. The necessary information (e.g., suture points in the case of the femoral bifurcation) may not be available to the surgical robot or may not be accessible to the surgical robot. The surgeon may provide the necessary input, for example, via a GUI, after which the surgical robot can continue its work.

[0329] Mode I supports fully autonomous control under user supervision. Mode I corresponds to Level 4 as described above, and also corresponds to Level 5, under the assumption that checking the robot to continue does not constitute human input / assistance.

Claims

1. A system (1) for autonomously performing a medical procedure that includes at least one step, - Computing unit (3), - An interface (4) for communicating with at least one actuator (5) for operating at least one surgical robot (6), - User interface for inputting user commands (2) and Equipped with, The computing (3) unit is - Autonomously control the operation of the actuator (5) to perform at least one step of the medical procedure, -Receive a control command from the user interface (2) in one form of a change command, a stop command, and a continue command. - Based on the control command, trigger a change operation, warning signal, continue signal, stop operation, or continue operation of the actuator. System (1) is adapted to be so.

2. The system according to claim 1, wherein the medical procedure is divided into a plurality of separate steps (21, ..., 29; 101, ..., 115), and the system is adapted to automatically request the reception of the control command before, after, and / or during each of the steps (21, ..., 29; 101, ..., 115).

3. The computing unit can operate in autonomous mode, fully degenerate mode, and / or partially degenerate mode. - In the autonomous mode, the computing unit (3) completely controls the operation of the actuator (5), - In the degraded mode, the computing unit (3) either (i) releases the actuator (5) so that a user can operate it manually in manual degraded mode, or (ii) controls the actuator (5) based on remote control commands provided by a user in remote degraded mode, according to claim 1 or 2.

4. The system according to claim 3, further comprising a switch unit (7) for switching operation between the autonomous mode, the fully degraded mode, and / or the partially degraded mode, and / or, in particular, between different levels of the partially degraded mode.

5. The switch unit (7) is controlled by the computing unit (3), - The operation can be automatically switched from the autonomous mode to the fully degraded mode or the partially degraded mode. - The system according to claim 4, which is controlled so that it can switch to the autonomous mode only upon command or verification by the user.

6. The system (1) includes a verification interface (2a) for inputting verification commands, and the verification interface (2a) is preferably, - Voice interface, - Mechanical buttons or switches, -mouse, - Joystick, -keyboard, - Tactile gloves, - Graphical user interfaces, especially touchscreens, - Motion detectors, especially gaze trackers or head motion detectors, - Eye-image interface, - Virtual reality or augmented reality interface, - 3D monitor, - Timer A system according to any one of claims 1 to 5, selected from the group consisting of the following.

7. The system further comprises a change interface (2b) for inputting start commands, change commands, continue commands, hold commands, and / or stop commands, wherein the change interface (2b) is preferably - Voice interface, - Mechanical buttons or switches, -mouse, - Joystick, - Tactile gloves, -keyboard, - Graphical user interfaces, especially touchscreens, - Motion detectors, especially gaze trackers or head motion detectors, - Eye-image interface, - Virtual reality or augmented reality interface, - 3D monitor A system according to any one of claims 1 to 6, selected from the group consisting of the following.

8. The aforementioned change instruction is, - Defining the access points to enter the patient's body, - Defining the position of the surgical robot relative to the access point for entering the patient's body, - Defining the implant position, - Defining the speed and trajectory of implant insertion, - Defining the position and / or orientation of the implant, - Defining deployment parameters for deploying the implant, particularly the balloon pressure for expanding the implant. - Defining the orientation and speed of the instrument during instrument retraction while the imaging device, particularly the endoscope camera, is in operation. - Define checklists and / or to-do lists. The system according to claim 7, selected from the group consisting of the following.

9. The system further comprises a stop interface (2c) for providing a stop command, and the stop interface (2c) is - Voice interface, - Mechanical buttons or switches, -mouse, - Joystick, - Tactile gloves, -keyboard, - Graphical user interfaces, especially touchscreens, - Motion detectors, especially gaze trackers or head motion detectors, - Virtual reality or augmented reality interface, - 3D monitor, - Timer, -button, - Device for detecting risks or unexpected events A system according to any one of claims 1 to 8, selected from the group consisting of the following.

10. The system according to any one of claims 1 to 9, wherein the system (1) has a memory for storing risk levels associated with at least one of the steps (21, ..., 29; 101, ..., 115).

11. The system according to claim 10, wherein the computing unit (3) is configured to execute a change instruction only when a predetermined instruction criterion for each of the risk levels is met.

12. The system according to claim 1, wherein the medical procedure is divided into a plurality of separate steps (21, ..., 29; 101, ..., 115), and the system is adapted to automatically request to receive the user command before or after the first step, or before or after the last step.

13. The system (1) is adapted for intraluminal procedures that involve intervention in a body tubule or body cavity, such as TAVI procedures, obesity procedures, bronchoalveolar procedures, ureteral bladder procedures, or vaginal uterine procedures, and the steps of the medical procedure are - Preoperative step (21), - Planning step (22), - Robot motion step (23), - Puncture step (14), - Navigation step (15) to move the valve from the access point to the target position, - Intermediate step (26), - Valve placement step (27), - Closing step (28), - Preoperative planning steps for obesity - Obesity robot positioning step, - Obesity Navigation Steps, - Obesity volume measurement step, - Obesity-related gastric reduction steps, - Obesity safety check steps, - Obesity volume verification step, - Obesity implant seating step, - Steps in the development of obesity implants, - Steps to prevent obesity, - Preoperative planning steps for bronchoalveolar surgery, - Bronchoalveolar robot positioning step, - Bronchoalveolar navigation step, - Step for measuring bronchoalveolar volume, - Bronchoalveolar safety check steps, - Steps for verifying bronchoalveolar volume, - Bronchoalveolar implant placement step, - Steps for deploying bronchoalveolar implants, - Bronchoalveolar retraction step, - Preoperative planning steps for ureteral bladder surgery, - Ureteral bladder robot positioning step, - Ureteral bladder navigation steps, - Ureteral bladder volume measurement step, - Ureteral bladder safety check steps, - Ureteral bladder volume verification step, - Ureteral bladder implant seating step, - Ureteral bladder implant deployment steps, - Ureteral bladder retraction step, - Pre-vaginal and uterine surgery planning steps, - Vaginal-uterine robot positioning step, - Vaginal and uterine navigation steps, - Vaginal and uterine volume measurement step, - Vaginal and uterine safety check steps, - Vaginal and uterine volume verification step, - Vaginal and uterine implant placement step, - Vaginal and uterine implant deployment steps, - Vaginal and uterine retraction step The system according to any one of claims 1 to 12, comprising at least one of the following.

14. The system according to any one of claims 7 to 13, wherein the computing unit (3) is further adapted to determine a risk parameter associated with a change based on a change instruction input via the change interface.

15. The system according to any one of claims 1 to 14, further comprising a separate emergency stop device (8).

16. The system according to any one of claims 1 to 15, further comprising an output interface (9) for providing information relating to at least one of the steps described above.

17. The output interface (9) is - Optical or visual output interface, - Augmented reality display, - Virtual reality display, - Haptic feedback device, - Audio output interface The system according to claim 16, selected from the group consisting of the following.

18. The computing unit (3) has the output interface (9) - Information regarding the current step performed by the system and / or the next step to be performed by the system, - Information regarding checklists and / or to-do lists, - Information regarding digital twins, - Information regarding simulated procedures, - Information regarding landmarks on patient images, - Information regarding the target area of ​​the needle, - Information regarding the planned and / or actual trajectory of the implant, - Information regarding the passage of the implant in a specified area, - Information on important areas, - Information regarding planned or actual equipment installations, - Information regarding the patient's physiological and / or pathological parameters and / or environmental data, - Information regarding serious events, - Information regarding the requested input and / or action The system according to any one of claims 16 or 17, which is adapted to provide information selected from a group consisting of the following.

19. The system includes at least one medical tool (10) operably connected to the actuator, in particular, - puncture needle, - Expander, - Introducer, - Guide wire, - Preferably a catheter having a pre-attached implant, - Endoscopic devices, especially growth robots, and - Closed unit The system according to any one of claims 1 to 18, further comprising a tool selected from the group consisting of the following.

20. Preferably a method for autonomously performing a medical procedure comprising at least one step, using a system described in at least one of the preceding claims, - The computing unit (3) autonomously controls the operation of the actuator (5) in order to operate the surgical robot to perform at least one step of the medical procedure, - The computing unit (3) receives a control command from the user interface (2) in one form of a change command, a stop command, and a continue command, The computing unit (3) triggers a change operation, deceleration operation, acceleration operation, holding operation, stopping operation, or continuous operation of the actuator (5) based on the control command. Methods that include...

21. The method according to claim 20, wherein the medical procedure is divided into a plurality of separate steps (21, ..., 29; 101, ..., 115), and the method includes automatically requesting the control command before, during, and / or after at least one of the steps (21, ..., 29; 101, ..., 115).

22. The aforementioned medical procedure is divided into multiple separate steps, - The computing unit (3) operates in autonomous mode and fully controls the operation of the actuator (5) to perform at least one step of the medical procedure. - The computing unit (3) operates in fully degraded mode, in manual degraded mode the computer unit (3) releases the actuator (5) for at least one step of the medical procedure, in remote degraded mode the computer unit (3) controls the actuator (5) for at least one step of the medical procedure based on remote operator control commands provided by the user, and / or The method according to any one of claims 20 or 21, wherein the computing unit (3) operates in a partially degraded mode and controls the operation of the actuator (5) to perform at least one step of the medical procedure based on communication with the user.

23. The method according to claim 22, wherein the method comprises switching between the autonomous mode, the fully degraded mode, and / or the partially degraded mode, and / or, in particular, between different levels of the partially degraded mode, in accordance with a predetermined hierarchical supervision model.

24. The computer unit (3) automatically switches from the autonomous mode to the partially degraded mode and / or the fully degraded mode, or from the partially degraded mode to the fully degraded mode. and / or The method according to claim 23, wherein the computer unit (2) requests a control command from the user before switching to the autonomous mode or before switching from the fully degraded mode to the partially degraded mode.

25. The computing unit (3) is - Access point for entering the patient's body, - The position of the surgical robot relative to the access point for entering the patient's body, - Implant position, - Speed ​​and trajectory of implant insertion, - Implant position and / or orientation, - Deployment parameters for deploying the implant, especially balloon pressure for expanding the implant. - Direction and speed of the equipment while it is being retracted, - Imaging device, especially the operation of the endoscope camera, - Checklist and / or To-Do list including intervention steps The method according to any one of claims 20 to 24, which includes receiving a control command relating to at least one of the following.

26. The method is adapted to intraluminal procedures such as TAVI procedures, obesity procedures, bronchoalveolar procedures, ureteral bladder procedures, or vaginal uterine procedures, and the computing unit (3) is - Preoperative steps, - Planning steps, - Robot movement steps, - Navigation steps to move the valve from the access point to the target position. - Intermediate step, - Valve placement step, and - Closing step, - Preoperative planning steps for obesity - Obesity robot positioning step, - Obesity Navigation Steps, - Obesity implant seating step, - Steps in the development of obesity implants, and - Steps to prevent obesity, - Preoperative planning steps for bronchoalveolar surgery, - Bronchoalveolar robot positioning step, - Bronchoalveolar navigation step, - Step for measuring bronchoalveolar volume, - Bronchoalveolar safety check steps, - Steps for verifying bronchoalveolar volume, - Bronchoalveolar implant placement step, - Steps for deploying bronchoalveolar implants, - Bronchoalveolar retraction step, - Preoperative planning steps for ureteral bladder surgery, - Ureteral bladder robot positioning step, - Ureteral bladder navigation steps, - Ureteral bladder volume measurement step, - Ureteral bladder safety check steps, - Ureteral bladder volume verification step, - Ureteral bladder implant seating step, - Ureteral bladder implant deployment steps, - Ureteral bladder retraction step, - Pre-vaginal and uterine surgery planning steps, - Vaginal-uterine robot positioning step, - Vaginal and uterine navigation steps, - Vaginal and uterine volume measurement step, - Vaginal and uterine safety check steps, - Vaginal and uterine volume verification step, - Vaginal and uterine implant placement step, - Vaginal and uterine implant deployment steps, - Vaginal and uterine retraction step The method according to any one of claims 20 to 25, for controlling at least one of the following.

27. The method according to any one of claims 20 to 26, wherein the computing unit (3) determines a risk parameter associated with a change based on a change instruction input via the change interface.

28. The computing unit (3) has an output interface, - Information regarding the current step performed by the system and / or the next step to be performed by the system, - Information regarding the checklist, - Information regarding digital twins, - Information regarding simulated procedures, - Information regarding landmarks on patient images, - Information regarding the target area of ​​the needle, - Information regarding the planned and / or actual trajectory of the implant, - Information regarding the passage of the implant in a specified area, - Information on important areas, - Information regarding planned or actual equipment installations, and - Information regarding the patient's physiological parameters and / or environmental data, - Information regarding serious events, - Information regarding the requested input and / or action The method according to any one of claims 20 to 27, which provides information selected from the group consisting of the following.

29. The computing unit (3) is at least one medical tool operably connected to the actuator (5), and in particular, - puncture needle, - Expander, - Introducer, - Guide wire, - Preferably a catheter having a pre-attached implant, - Endoscopic devices, especially growth robots, - Imaging device, and - Closed unit The method according to any one of claims 20 to 28, for controlling a medical tool selected from the group consisting of the following.

30. A computer program comprising program code for performing the steps of the method according to any one of claims 20 to 29 when the program is executed on a computer (11), wherein the program code preferably uses a pre-trained neural network and / or artificial intelligence software.

31. A computer program product which can be directly loaded into the internal memory of a digital computer (11) and includes a portion of software code that performs a method step of at least one of claims 20 to 30 when the program is running on the computer (11), preferably the software code is adapted to access a pre-trained neural network and / or artificial intelligence software.

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