System for autonomously implementing medical procedures

Abstract

The invention relates to a system (1), a method and a 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 instructions. The computing unit (3) is adapted to autonomously control the operation of the actuator (5) to perform said at least one step of the medical procedure, to receive control instructions from said user interface (2) in the form of one of a change instruction, a stop instruction and a continuation instruction, and to cause a change operation, a stop operation or a continuation operation of the actuator according to the control instructions.

Description

TECHNICAL FIELD

[0001] The present invention relates to a system, method and computer program for autonomously performing a medical operation according to the independent claims. BACKGROUND

[0002] Robotic surgery or robot-assisted surgery enables physicians to perform a variety of types of complex operations more precisely, more flexibly and more controllably than traditional techniques. Robotic surgery is often associated with minimally invasive surgery, i.e. operations through tiny incisions. It is also used for certain traditional open surgery operations.

[0003] The most widely used clinical surgical robots comprise a camera arm and a mechanical arm to which a surgical instrument is attached.

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

[0005] The six levels are defined as follows: Level 0 (no autonomy, where the motion of the robot is controlled only by the operator, without any support or constraints provided), Level 1 (robotic assistance, where the system provides active constraints to guide the motion of the operator or virtual fixtures to enhance visualization of the surgical site), Level 2 (task autonomy, where the system is able to complete a specific surgical task based on specifications provided by the operator), Level 3 (conditional autonomy, where the system understands the surgical scene, plans and executes a specific task and updates the plan during execution), Level 4 (high autonomy, where the system interprets preoperative and intraoperative information, formulates an intervention plan consisting of a sequence of tasks, executes the plan autonomously and re-plans when needed), and Level 5 (full autonomy).

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

[0007] For example, robotic-assisted surgery of level 0 is known in mitral valve repair, thoracoscopic surgery and robotic-assisted surgery.

[0008] In the field of surgical robots, there are ethical and legal concerns regarding the consequences of decision errors and incorrect robot behavior, which can lead to severe injuries or even death. SUMMARY

[0009] It is an object of the present invention to overcome the disadvantages of the prior art. In particular, the system and method according to the present invention shall provide for a robotic surgery that meets clinical needs, in particular meets the respective applicable legal requirements, and allows for a high degree of autonomy.

[0010] These and other objects are solved by the system, method and computer program according to the independent claims.

[0011] The present invention provides a system for autonomously conducting a medical operation comprising 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 instructions. In the present application, a user generally refers to a human user.

[0013] An actuator is a component that transforms an electrical signal into mechanical movement or other physical action (e.g. pressure increase, temperature change, etc.) and is responsible for moving or controlling a mechanism or system of a surgical robot (e.g. by moving a component or opening a valve).

[0014] The system is connected or connectable to the actuator, in particular to the actuator of a surgical robot or surgical device, via the actuator interface.

[0015] The system can comprise the actuator, in particular a surgical robot comprising the actuator.

[0016] In the present application, a surgical robot can comprise at least one robotic arm, on which a light source, a sensor device and / or a surgical device are attached or attachable. The sensor device may, for example, comprise a camera or an ultrasound probe. The surgical device can comprise or can be functionally connected to a surgical tool, such as a guide wire, an endoscope, a puncture needle, a deployment tool comprising an implant valve or a dilatation balloon.

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

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

[0019] The computing unit can also be adapted to perform a user-guided operation of the actuator to implement one step of the medical operation.

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

[0021] The change instruction can be used to select, define and / or modify a surgical step operated by the surgical robot.

[0022] The change instruction can be a new instruction not related to a surgical step to be processed or in progress.

[0023] The stop instruction is used to complete or interrupt a surgical step or a sequence of surgical steps.

[0024] The continue instruction is used to validate or confirm a surgical step or a sequence of surgical steps.

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

[0026] The computing unit can be adapted to generate a signal based on the control instruction and send the signal to the actuator interface.

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

[0028] The computing unit can provide an autonomous running function for executing at least one step of the medical operation.

[0029] The computing unit can be adapted to simulate a surgical step and in particular to determine critical phases and critical areas.

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

[0031] The computing unit can be adapted to calculate the result of a user input / user change and to determine possible risks related to the respective input.

[0032] The computing unit can be adapted to assist a surgical step controlled entirely by the user, for example to emit sound and / or light signals during the surgical step, for example during navigation, to help positioning, or to suppress tremor movements of the operator.

[0033] The computing unit can be adapted to verify a surgical step, for example to verify whether an implant is correctly placed and anchored by the operator.

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

[0035] The actuator interface can comprise a socket or a plug for mating with a plug or a socket of a surgical robot. The actuator interface can comprise a wireless connection for mating with a surgical robot.

[0036] The user interface can be a master interface for communicating with medical staff. The user interface can comprise at least one of a monitor, a keyboard, a touch screen, a joystick, a hand grip, a control panel, a motion tracker, a gaze tracker, a microphone and a voice recognizer, a loudspeaker, a camera and an image recognizer.

[0037] The medical procedure can be divided into a plurality of separate steps. Each step can initially be associated with a predetermined level of autonomy.

[0038] For example, the medical procedure can start with a preparation step, in which the devices of the operating room are checked.

[0039] In a further step, a wheeled cart carrying the robots and cameras can enter the operating room. External cameras fixed in the room can be connected. If necessary, the cameras can be calibrated. The cart can be placed relative to the desired working position and can be locked to a reference point, for example on the floor or on a table.

[0040] The robots can be placed on either side of the table, preferably close to the desired access site, preferably centered relative to the length of the patient, for example between the patient's knee and abdomen.

[0041] The access site on the patient can be known from preoperative preparation information or can be detected, as for example identified by a drape window.

[0042] In a further step, the system can be set up to establish and / or check all connections, including power supply of all components. Software can be started and consumables for the medical procedure can be prepared.

[0043] In a further step, the system can be initialized. This includes checking whether all software components are available and working properly, settings for patient detection and robot homing.

[0044] The steps can initially be associated with a fully autonomous mode and can be carried out fully autonomously on a regular basis. Manual verification and / or control instructions can be requested and received as needed, for example if an unexpected or unpredictable event occurs.

[0045] In the next step, the actual medical procedure starts. For example, in the case of a puncture procedure, patch detection and robot arm movement can start. This step can initially be carried out in a partially degraded autonomous mode. Manual verification and / or control instructions can be requested and received.

[0046] Additionally, an ultrasound scan can be started. The artery and the puncture point can be automatically detected. This step can initially be implemented in a partially degraded autonomous mode. Manual verification and / or control instructions can be requested and received.

[0047] In a subsequent puncture step, the needle can be inserted and the needle can be stopped. This step can initially be implemented in a partially degraded autonomous mode. Manual verification or manual intervention can be required.

[0048] In a subsequent step, the introducer can be placed. This step can initially be implemented in a partially degraded autonomous mode. Manual verification or manual intervention can be required.

[0049] Finally, the robot can be withdrawn. This step can initially be implemented in a fully autonomous mode and can be performed fully automatically on a regular basis.

[0050] During, before and after each step, the system can be adapted to switch to a mode of lower autonomy automatically or according to respective instructions entered by the user via the user interface. The system can be adapted to automatically request or receive said control instructions before, after and / or during each step.

[0051] For example, the system can be adapted to automatically request or receive said control instructions during a step if an emergency situation occurs, detected by the system, the user or an external system.

[0052] Optionally, the system can be adapted to automatically request to receive said control instructions before and / or after the sequence of steps.

[0053] According to a predetermined criticality of each step, the system can be adapted to automatically request to receive control instructions only before more critical steps.

[0054] The system can also be adapted to automatically request to receive said control instructions during a step, for example when a single step takes a long time, such as the navigation step.

[0055] The computing unit can be adapted to receive emergency stop instructions at any time.

[0056] The operator can be required by the system to verify each step or only individual steps. The operator can interact in each step.

[0057] The computing unit is capable of operating in an autonomous mode, a fully degraded mode and a partially degraded mode.

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

[0059] In autonomous mode, the system can execute each step without human verification. The system runs entirely on non-human input. Autonomous mode corresponds to level 5 (full autonomy) as described above.

[0060] In fully degraded mode, the computing unit either releases the actuators so that they can be freely and manually operated by the user in manual degraded mode, or controls the actuators based on remote operation control instructions provided by the user in remote operation degraded mode.

[0061] In manual degraded mode, the system is operated completely manually. The operator can directly physically interact with the surgical robot.

[0062] Optionally, the surgical robot can be operated in remote operation degraded mode, in which the actuators are controlled by the computing unit receiving remote operation control instructions from a remote operation user interface. The operator can directly control the surgical robot via the computing unit.

[0063] In fully degraded mode, the computing unit can provide output, i.e. send control signals to the actuator interface, based on human input only. The computing unit does not conduct any decision process and leaves full control to the operator. However, there can be some algorithmic autonomy in fully degraded mode, such as tremor suppression and redundancy elimination, which do not interfere with the operator’s actions.

[0064] Fully degraded mode corresponds to level 0 as described above.

[0065] In partially degraded mode, the computing unit controls the actuators based on communication with the user to implement at least one step of the medical operation.

[0066] In partially degraded mode, a distinction can be made between different levels of partially degraded mode.

[0067] The system can operate autonomously under supervision. The user can give go / no-go input in each pre-defined step. In addition to verification of intermediate steps, the system can run entirely on non-human input. This level corresponds to level 4 (high autonomy) as described above, in which the computing unit interprets preoperative and intraoperative information, formulates an intervention plan consisting of a sequence of tasks, autonomously guides the execution of this plan and replans when necessary. The operator supervises the system in a discrete control paradigm.

[0068] In partially degraded mode, the system can operate in a degraded manner, but can be enhanced corresponding to levels 1, 2 and / or 3 as described above.

[0069] At level 1, the system can provide some support to the operator / user, but can never take over the control of an ongoing action. The system can support the operator to perform a specific surgical action. The system can provide passive assistance, for example by providing additional information to the operator when requested. The system can provide enhanced imaging, for example augmented reality. The system can provide active assistance, for example limiting the movement of a surgical instrument.

[0070] At level 2, the computing unit can control the steps of the operation, but is not allowed to define any parameters for planning the task. The operator provides the information needed to proceed with the action.

[0071] At level 3, the system can conceive strategies to proceed with a specific task, while always relying on a human operator to approve the most appropriate strategy to be pursued. Part of the operation can be performed autonomously, such as navigating a flexible endoscopic robot in an unstructured environment or positioning an access point for a laparoscopic procedure.

[0072] In full and partial degraded modes, the system can receive direct inputs via a GUI (for example for access point selection for a laparoscopic entry) and / or other input systems (for example a gamepad for setting needle depth or ultrasound probe position and orientation).

[0073] In full and partial degraded modes, the system can wait for input from a human if a step is not validated, which can be a retry command or a direct instruction (for example, if the AI determined access point is incorrect, the user can specify via the GUI where the actual access point should be).

[0074] The system can comprise a switching unit for switching the operation between the autonomous mode, the full degraded mode and / or the partial degraded mode.

[0075] Optionally or additionally, the system can comprise a switching unit for switching the operation between different levels of the partial degraded mode.

[0076] Preferably, the operation mode is selected before the first step of the medical operation. However, the switching unit can be adapted to switch the operation at any time during the medical operation as needed. Thus, the operator can change the level of autonomy corresponding to the progress of the surgical operation. When he or she considers it necessary, he or she can take more control or he or she can release control to the system.

[0077] In the autonomous mode and the partial degraded mode, the steps of the surgical operation can be run automatically until they are stopped or until a stop criterion is met.

[0078] The operator can be forced by the system to supervise the automatically run steps, for example by a dead man's switch.

[0079] The switching unit can be controlled by the computing unit in such a way that the operation can be automatically switched from the autonomous mode to the fully or partially degraded mode and that the operation can only be switched to the autonomous mode under user instruction or validation.

[0080] In a similar way, the operation can be automatically switched to a lower autonomy level, whereas for a change to a higher autonomy level, the user's instruction and / or validation is necessary.

[0081] Generally, the computing unit can operate with a pyramid decision structure. The lowest level is related to low-level signal processing, the next level uses AI (artificial intelligence) for image and / or sensor processing, the next level uses AI for context interpretation, and at the highest level, all steps of the operation can be controlled by the computing unit.

[0082] Context-sensitive AI can provide for autonomy level degradation or operation stop, but can not upgrade the autonomy level.

[0083] However, at any time of the operation, for any autonomy level, the computing unit operation gives full rights to the operator if the operator requests.

[0084] The computing unit can be adapted to receive switching instructions from the user interface and / or to guide the switching based on the switching instructions, in particular to change the autonomy level to a higher autonomy level.

[0085] The system can comprise a validation interface for inputting validation instructions. The validation interface is preferably selected from the group of: a voice interface, a mechanical button or switch, a mouse, a joystick, a haptic glove, a graphical user interface, in particular a touch screen, a motion detector, in particular a gaze tracker or a head motion detector, a virtual reality or augmented reality interface, an eye-to-image interface, a 3D monitor, in particular a holographic projection combined with a haptic glove or motion detection, and a timer.

[0086] The validation interface can be an interface for user input. The user interface can comprise the validation interface.

[0087] Optionally or additionally, the validation interface can receive non-human input, for example input from a timer or a sensor device.

[0088] The computing unit can be adapted to compare a signal received by the validation interface from an external device, such as a timer or a sensor, with a predetermined condition and to provide a signal or an action based on the comparison.

[0089] The system can comprise a change interface for inputting the change instruction and for initiating, continuing, holding or stopping the instruction. The change interface is preferably selected from the group of a voice interface, a mechanical button or switch, a mouse, a joystick, a haptic glove, a keyboard, a graphical user interface, in particular a touch screen, a motion detector, in particular a gaze tracker or a head motion detector, an eye-image interface, a virtual reality or augmented reality interface, and a 3D monitor, in particular a holographic projection in combination with a haptic glove or a motion detector.

[0090] The change interface is an interface for inputting by a user, in particular to the computing unit, to the system, and the user interface can comprise the change interface.

[0091] Preferably, the system is adapted for use in an intraluminal operation, in particular an intravascular or gastrointestinal surgical operation, such as placing and fixing an implant within a body lumen of a patient.

[0092] The change instruction can be selected from the group of defining an access point for accessing the patient's body, defining a position of the surgical robot relative to the access point for accessing the patient's body, defining an implant position, defining a speed and trajectory of implant insertion, defining a target position and / or orientation of the implant, defining a deployment parameter for deploying the implant, in particular a balloon pressure for expanding the implant, defining a direction and speed of an instrument during instrument retraction, operating an imaging device, in particular an endoscopic camera, and defining a check list and / or to-do list comprising intervention steps.

[0093] The check list comprising intervention steps can be defined in a machine-readable format and / or can be defined in a format for outputting the list at the output interface, so that the user can check, revise and / or update the list.

[0094] In this context, "defining" means that either all information about the respective action is input by the user, or the computing unit is adapted to define the information needed for the respective action as required, or the computing unit is adapted to modify a predetermined action.

[0095] The change instruction can comprise complete information about the respective action, i.e. the information defining the respective action is completely input by the user; or the change instruction can comprise a command relating to the respective action, i.e. the computing unit determines the information needed for the respective action.

[0096] The computing unit can define the respective action on the basis of data input by the user, on the basis of data of a database stored in the system or in a memory, and / or on the basis of data provided by another system, e.g. a sensor device.

[0097] For example, in order to define an access point for accessing the patient's body, the user can input all data of a selected target site on the patient's body or the computing unit can be requested to calculate the access point, e.g. via a change interface, e.g. based on image analysis. The respective change instruction can involve changing a previously input or previously defined access point.

[0098] For example, in order to define a position of a surgical robot relative to an access point for accessing the patient's body, the user can input all data required for placing the surgical robot, e.g. directly placing the surgical robot at a selected site in a selected orientation via a change interface. In this case, the computing unit operates based on the change instruction input by the user.

[0099] Alternatively, the respective change instruction can involve starting a positioning routine, wherein the computing unit can define a path and orientation of the surgical robot and / or can autonomously control the movement of the surgical robot.

[0100] Alternatively, the change instruction can involve a change of a previously input or previously calculated position and orientation of the surgical robot.

[0101] Similarly, in order to define a position of an implant, e.g. a heart valve, the user can input all data of the final implant site, e.g. via a change interface, or the computing unit can be adapted to define the implant site and the user can input a command for defining the implant position.

[0102] Alternatively, the respective change instruction involves a change of a previously input or previously determined implant position.

[0103] Similarly, in order to define a speed and trajectory of the implant insertion, in particular an endovascular placement of a heart valve, the user can input all data of the speed and trajectory of the implant insertion, e.g. via a change interface. Alternatively, the computing unit is adapted to define the speed and trajectory of the implant insertion and can be prompted to determine the speed and trajectory.

[0104] Alternatively, the respective change instruction can involve a change of a previously input or previously determined speed and trajectory of the implant insertion.

[0105] Similarly, in order to define a detailed position and / or orientation of the implant, the user can input all data of the detailed position and / or orientation of the implant, e.g. via a change interface, or the computing unit can be adapted to define the detailed position and / or orientation of the implant and the user can input a command for prompting the computing unit to define the detailed position and / or orientation.

[0106] Alternatively, the respective change instruction can involve a change of a previously defined detailed position and / or orientation of the implant.

[0107] Similarly, in order to define the deployment parameters for deploying the implant, the user can input all data of the deployment parameters, e.g. via a change interface, or the computing unit can be requested to determine the deployment parameters. Optionally, the respective change instruction relates to a change of previously input or previously determined deployment parameters.

[0108] Similarly, in order to define the direction and speed of the instrument during instrument retraction, the user can input all data of the direction and speed of the instrument, e.g. via a change interface, or the computing unit can be adapted to define the direction and speed of the instrument and the user can input a command to guide the computation of the direction and speed. Optionally, the respective change instruction can relate to a change of previously defined direction and speed of the instrument.

[0109] For example, in order to define the check list comprising all intervention steps, all steps or partial steps can be manually input by the user, and / or steps can be proposed by the system, and / or the check list can be edited during planning, and / or the check list can be updated automatically as well as manually.

[0110] The system can further comprise a stop interface for inputting a stop instruction. The stop interface is preferably selected from the group of: a voice interface, a mechanical button or switch, a mouse, a joystick, a haptic glove, a keyboard, a graphical user interface, in particular a touch screen, a motion detector, in particular a gaze tracker or a head motion detector, a virtual reality or augmented reality interface, a 3D monitor, in particular a holographic projection in combination with a haptic glove or a motion detector, a timer, a button, and a detection device for detecting a risk or an unexpected event.

[0111] The detection device can be a device for detecting an environmental condition, a device for detecting a system state, or a device for detecting a patient feature such as a vital sign of a patient. The detection device can provide a stop instruction in case a signal captured by the detection device is below or above a predefined threshold.

[0112] The detection device can provide a stop instruction in case a system component failure is detected, or in case an unexpected behavior of the patient, e.g. a start of movement, is detected.

[0113] The stop instruction can be provided to the computing unit to immediately stop a surgical step or to reduce the level of autonomy.

[0114] The system can have a memory for storing a risk level associated with at least one of the steps.

[0115] The risk level can be pre-stored. The operator can assign certain pre-determined risk levels to respective steps, and / or the operator can specify certain risk levels. The operator can change the risk level for an ongoing operation step.

[0116] Before or during the medical procedure, but before the step is performed, the operator can change the risk level for at least one step.

[0117] Certain risk levels can be associated with respective predetermined instruction criteria, e.g. respective inputs by the user.

[0118] A certain risk level can be associated with a certain required number of verification instructions. For example, a step with a high risk level can require the user to input at least two verification instructions, in particular before, during and / or after the step. The step can require phased instructions, on the one hand regarding more general aspects of the step and on the other hand regarding more specific aspects of the step.

[0119] A step with a moderately high risk level can require only one verification instruction. A step with a low risk level can not require verification at all.

[0120] The verification instruction can be a go / no-go instruction.

[0121] The computing unit can be adapted to only execute the change instruction if the predefined instruction criteria of the respective risk level of the respective step are met.

[0122] The medical procedure can be divided into a plurality of separate steps, wherein the system is adapted to automatically request to receive said user instructions before or after the first step or before or after the last step, in particular only before the first step and / or after the last step. In this case, typically, the system operates in an autonomous mode for which no regular input by the user is required during the medical procedure.

[0123] The system can be adapted for a medical procedure comprising an endoluminal approach such as an intravascular or a gastrointestinal approach.

[0124] The system can be adapted for an endoluminal procedure that intervenes a body tube or a cavity such as a TAVI procedure, a weight loss procedure, a bronchial alveolar procedure, a ureter-bladder procedure or a vagina-uterus procedure.

[0125] In particular, the system can be adapted for a TAVI (Transcatheter Aortic Valve Implantation) procedure. Steps of a medical TAVI procedure can comprise at least one of the following: a pre-operative step, a planning step, a robotic movement step, a puncture step, a navigation step, an intermediate step, a valve placement step and a closure step.

[0126] The pre-operative step can comprise imaging, in particular 3D reconstruction. The pre-operative step can comprise a simulation of at least some steps of the TAVI operation, preferably a simulation of the entire TAVI operation. The pre-operative step can comprise determining critical phases of the operation and critical regions in the patient's body. The user can define respective risk levels associated with the steps and / or the patient's regions, or the computer unit can assess the phases of the operation and the patient's regions. The pre-operative step can comprise setting a caution marker with respect to respective critical phases of the operation or with respect to respective critical regions of the patient. The caution marker can be provided during subsequent steps of the medical operation.

[0127] The pre-operative step can comprise dilating the calcified vessel or dilating the native valve, in particular using a separate instrument.

[0128] The planning step can comprise at least one of: (i) defining a puncture position and / or an access point, (ii) defining an access path, (iii) defining at least one of an implant valve type, an implant position within the aortic valve, and an implant valve size.

[0129] Generally, a combination of a type of implant valve having a suitable size, its intended position within the native aortic valve, a suitable access point, and a suitable path from the access point to the intended position within the aortic valve has to be specified. Each planning step can be either input by the user, selected by the user from a list stored in the system, defined by the computer unit, and / or altered by the user.

[0130] The robotic movement step can comprise at least one of: detecting an access patch and / or an access point, and moving a surgical robot, in particular a surgical tool mounted thereon, to the access point or the access patch.

[0131] The robotic movement step can be automatically guided by the computer unit. The user can alter the access point and the position and orientation of the surgical robot at any time before and during the robotic movement step.

[0132] The puncture step can comprise at least one of: detecting an artery, aiming a needle, placing the needle, i.e. puncturing, placing a dilator, and placing a dilator. The aiming of the needle can be performed, for example, based on a bifurcation.

[0133] The system can position and re-orient the needle tip according to a target point in the patient's body, e.g. an artery bifurcation, before moving the needle into the patient's body.

[0134] Since the needle can be positioned and oriented outside the human body, the access can be performed by moving the needle only in a longitudinal direction along its axis.

[0135] The navigation steps can comprise moving the implant valve from the access point to the target position. The navigation steps can comprise placing a guidewire, guiding the valve into the artery, detecting specific anatomical features such as thin vessel walls, vessel branches, vessel bulges or calcifications, determining movement parameters for the valve depending on the anatomical features, e.g. slowing down movement within the aortic arch or selecting a specific tool for advancing e.g. a balloon for vessel dilation, and moving the valve along the guidewire depending on the parameters.

[0136] Before or during each navigation step, the computing unit can request a verification instruction before proceeding.

[0137] The navigation steps can comprise dilating a calcified vessel or dilating a native valve.

[0138] The intermediate step can comprise crossing the native valve with the implant valve. This step can require additional verification instructions in addition to other verifications.

[0139] The valve placement steps can comprise moving the implant valve within the native valve, holding the implant valve in a selected position, deploying the implant valve and checking the function of the deployed implant valve.

[0140] During moving the implant valve, the path can be altered by the operator or based on a proposal of the computing unit.

[0141] The deployment of the implant valve can comprise release and expansion of the implant valve. The pressure of the deployment balloon can be adapted during the deployment step.

[0142] The function of the deployed implant valve can be tested by detecting a pressure gradient along the implant valve or by imaging the valve in the presence of contrast agent. The amount of contrast agent can be adjusted during this step.

[0143] The output device can emit an audible and / or visual signal, such as a beep, a voice signal or an LED signal, during navigation to assist the user in guided positioning, in particular during the arterial access, valve crossing or placement.

[0144] Each step or at least one step of the valve placement steps can be guided by the user, can be controlled by the computing unit and / or can be altered by the user.

[0145] A verification instruction of the operator input can be requested to ensure that the implant valve is correctly placed and anchored.

[0146] The closure steps can comprise the removal of the surgical tools, the closure of the artery and the check whether the artery is correctly closed, e.g. via ultrasound imaging or via fluoroscopy.

[0147] Each step or at least one step of the closure steps can be guided by the user, can be controlled by the computing unit and / or can be adapted by the user.

[0148] The system can also be adapted for transcatheter valve implantation procedures, in particular for heart valves other than the aortic valve. In this case, the steps of the medical procedure can comprise the same or similar steps as for a TAVI procedure that has been adopted for the particular valve.

[0149] Optionally, the system can be adapted for a weight loss procedure. The steps of the medical procedure can comprise at least one of a weight loss pre-procedure planning step, a weight loss navigation step, a weight loss volume measurement step, a weight loss gastric reduction step, a weight loss safety check step, a weight loss volume verification step, a weight loss implant landing step, and a weight loss retraction step. Each weight loss procedure step can comprise sub-steps.

[0150] A weight loss procedure generally refers to a surgical procedure aimed at reducing the weight of a severely overweight patient. Procedures in this context include sleeve gastrectomy and / or the use of implants such as gastric bypass or gastric bands. In the present application, a weight loss procedure can in particular involve the transoral placement of an endoscopic gastrointestinal bypass device, a gastric balloon, a gastric stimulator, a duodenal sleeve, or an anastomosis device. The bypass device can be a sleeve port attached to the end of the esophagus with transmural anchors and connected to a 120 cm long sleeve that diverts undigested nutrients to the jejunum.

[0151] A weight loss procedure also involves "sleeve gastrectomy", in which the volume of the stomach is reduced by applying sutures, staples, or anchors under endoscopic vision.

[0152] In the weight loss volume measurement step, the total volume can first be detected. In the weight loss gastric reduction step, sutures, staples, or anchors can be applied.

[0153] In the weight loss safety check step, the suture depth, suture position, and / or suture strength can be detected and compared to at least one predetermined specification. It can be determined whether the suture depth, suture position, and / or suture strength meets the at least one predetermined criterion.

[0154] In the weight loss volume verification step, it can be detected whether the intended final volume has been reached.

[0155] The weight loss pre-procedure planning step, preferably using a virtual "standard" patient, can comprise defining a gastric volume reduction, a weight loss treatment type, an implant size, in particular length, further weight loss procedure steps, navigation paths, checkpoints, deployment sites or initial positions of surgical robots.

[0156] Via the user interface, the weight loss treatment type can be selected, e.g. the operator can plan a gastric sleeve implantation or a gastric volume reduction.

[0157] A virtual patient can be created based on patient morphology, which can be determined by imaging methods and / or by previous measurements.

[0158] The weight loss navigation steps can comprise moving the implant to a target position, guiding the tool and / or the implant to the gastrointestinal tract, detecting specific anatomical features, setting motion parameters for the implant depending on the anatomical features, such as slowing down the motion during the sphincter crossing, and moving the implant according to the parameters.

[0159] The weight loss navigation steps can comprise controlling the correct path to the stomach and within the stomach, through the pharynx, through the sphincter and / or to the target position.

[0160] The output device can emit an audible and / or visual signal during navigation, such as a beep, a voice signal or an LED signal, to assist the user in the guided positioning.

[0161] The air pressure or the force of the deployment tool can be adapted when crossing the pharynx and / or the sphincter.

[0162] When the implant crosses the pharynx, the computing unit can generate a signal that is sent to the user interface and / or the output interface with which the patient is invited to swallow.

[0163] The weight loss navigation steps can comprise imaging the implant insertion process, for example in a 3D model reconstruction.

[0164] The weight loss navigation steps can be performed autonomously.

[0165] The weight loss implant landing steps can comprise positioning the implant in a final position within the gastrointestinal tract, deploying the implant, in particular anchoring the implant and expanding the implant.

[0166] During landing, the operator can adjust the position and orientation of the implant and can adjust the pressure, for example of an inflatable anchor, preferably based on sensors on the device and / or the delivery system, such as pressure sensors or force sensors.

[0167] The weight loss retrieval steps can comprise disassembly of the tool.

[0168] Each step or at least one of the steps in the weight loss operation steps can be guided by the user, can be controlled or assisted by the computing unit, or can be modified by the user.

[0169] After or during each step or individual step, a verification instruction can be requested.

[0170] The system can comprise an image tool, such as an endoscopic camera, and / or any other measuring device for real-time measurement of the stomach to monitor all weight loss steps. The image tool can comprise an endoscopic camera, a stereoscopic camera, a narrow-band imaging device and / or an ultrasound imaging device.

[0171] Real-time measurements can be based on real-time stereoscopic reconstruction, or use a laser source / light source to project a pattern onto the stomach wall to aid stereoscopic 3D reconstruction.

[0172] The image tool can show the digestive behavior prior to or during the weight loss operation, for example showing the path taken by the food in real-time video.

[0173] Optionally, the system can be adapted for broncho-alveolar operations, similar to the weight loss operations as described above. Then the steps of the medical operation can comprise at least one of the following: a broncho-alveolar pre-operative planning step, a broncho-alveolar navigation step, a broncho-alveolar volume measurement step, a broncho-alveolar safety check step, a broncho-alveolar volume verification step, a broncho-alveolar implant landing step, and a broncho-alveolar retraction step. Each broncho-alveolar operation step can comprise sub-steps.

[0174] Optionally, the system can be adapted for ureter-bladder operations, similar to the weight loss operations as described above. Then the steps of the medical operation can comprise at least one of the following: a ureter-bladder pre-operative planning step, a ureter-bladder navigation step, a ureter-bladder volume measurement step, a ureter-bladder safety check step, a ureter-bladder volume verification step, a ureter-bladder implant landing step, and a ureter-bladder retraction step. Each ureter-bladder operation step can comprise sub-steps.

[0175] Optionally, the system can be adapted for vagina-uterus operations, similar to the weight loss operations as described above. Then the steps of the medical operation can comprise at least one of the following: a vagina-uterus pre-operative planning step, a vagina-uterus navigation step, a vagina-uterus volume measurement step, a vagina-uterus safety check step, a vagina-uterus volume verification step, a vagina-uterus implant landing step, and a vagina-uterus retraction step. Each vagina-uterus operation step can comprise sub-steps.

[0176] The computing unit can be adapted to determine a risk parameter related to the change based on the change instruction input via the change interface. The computing unit can further be adapted to provide a risk parameter or a request for a verification instruction, for example a further change instruction or a do / not do instruction, depending on the risk parameter. The computing unit can further be adapted to provide a warning signal, preferably an optical or acoustic warning signal, depending on the risk parameter. In any case, the respective signal is sent to the output interface.

[0177] The risk parameter can be one selected from a predetermined risk category, for example a predetermined risk level, and / or the risk parameter can relate to a series of consequences resulting from the change instruction, such as a failure of the medical operation step or harm to the patient.

[0178] The system can comprise at least one separate emergency stop device. The separate emergency stop device can be arranged close to the patient and / or close to the computing unit and / or close to the surgical robot, so that the user can react immediately to an unexpected event.

[0179] The separate emergency stop device can be integrated in the user interface, for example as a separate button or control area, for example displayed on a monitor. Preferably, the separate emergency stop device is provided as a separate physical unit.

[0180] Preferably, the separate emergency stop device is provided in addition to the stop interface.

[0181] The system can comprise an output interface for providing information to the user, in particular information related to at least one of the steps.

[0182] The output interface can be adapted to receive signals from the computing unit and preferably from a unit separate from the system, such as a sensor device.

[0183] The output interface can comprise a visual and / or an acoustic unit. The visual unit can display light signals, text, images, movies and / or holographic information. The output unit can be part of the user interface.

[0184] The output interface can be selected from the group of an optical or visual output interface, an augmented reality display, a virtual reality display, a haptic feedback device or an acoustic output interface.

[0185] The optical or visual output interface can comprise a light emitter such as an LED light, or a monitor, or in particular a projector for projecting information such as pictures or movies onto the patient's body, or a 3D monitor for providing e.g. a holographic projector. The optical or visual output interface can comprise VR glasses.

[0186] The output interface can be a combination of a 3D monitor and a haptic feedback device such as a haptic glove.

[0187] The output interface can be able to receive user input and can associate this input with the displayed information. For example, the output device can be a combination of a holographic display device and a haptic glove, so that the user can rotate and move the hologram.

[0188] The output interface can support the user in his / her input. For example, the user can change a path by moving an animated path presented by the output interface.

[0189] The acoustic output interface can provide an acoustic alarm signal or can comprise a speech synthesizer.

[0190] The output interface can be part of the user interface.

[0191] The computing unit can be adapted to generate and send a signal to the output interface.

[0192] The computing unit can be adapted to provide information to the output interface selected from the group of:

[0193] information about the current step implemented by the system and / or the next step to be implemented by the system,

[0194] information about a checklist containing (preferably all) intervention steps,

[0195] information about the digital twin,

[0196] information about the simulated operation,

[0197] information about a marker point on the patient,

[0198] information about a target area of a needle,

[0199] information about a planned and / or actual trajectory of an implant,

[0200] information about a passage of an implant in a predefined area,

[0201] information about a critical area and / or a critical step,

[0202] information about a planned and / or actual instrument retraction,

[0203] information about physiological parameters of the patient and / or environmental data,

[0204] information about a requested input and / or action.

[0205] The information about the current step implemented by the system and / or the next step to be implemented by the system can provide feedback to the operator and / or the patient about the stage of the operation.

[0206] For example, the computing unit can be adapted to provide information to the output interface about the tool or implant reaching a region of interest (e.g. an annulus or a sphincter), indicating that the system is ready for the next operation step. The information about the current and / or next step can implicitly request one of the control instructions as described above.

[0207] The computing unit can be adapted to provide information about past or planned steps of the medical operation to create a report and / or to predict a possible next step, thereby facilitating planning the operation.

[0208] The computing unit can create a report or assist in creating a report.

[0209] Information about the current step and / or the next step can be provided using a detailed check list, which can be automatically updated in manual mode or manually updated in degraded mode.

[0210] Irrespective of the mode of operation, the computing unit can be adapted to provide information to the output interface in form of a check list, which preferably comprises all intervention steps. The system can display the check list.

[0211] The check list can be edited during the planning period.

[0212] Generally, the check list documents the instruments and their positions.

[0213] In autonomous mode, the check list can inform the practitioner which overall (intervention) step (e.g. access) was performed, which steps have been validated, and within this step, which sub-steps (e.g. needle puncture, dilator entry, introducer entry, dilator withdrawal, needle withdrawal, etc.) were performed and will be performed.

[0214] In degraded mode, the check list can remind the clinician which instruments have to be deployed and which operations have to be performed. Additionally, the check list can document what has already happened.

[0215] Manual updates and / or edits can be done via the input interface, e.g. via the user interface, the change interface or the validation interface as described above.

[0216] The digital twin can comprise a virtual representation of the patient’s anatomy of interest, which facilitates planning and intraoperative decision making. The digital twin can be shown as a two-dimensional image or a reconstructed 3D model. The digital twin can comprise specific anatomical features of the patient, e.g. calcifications. The digital twin can comprise specific marker points selected by the user or determined and set by the computing unit.

[0217] The simulation operation can comprise information about critical steps of the medical operation and critical regions of the patient, where the operator needs to pay more attention, or the simulation operation can indicate critical phases and critical regions.

[0218] The computing unit can provide data of the marker points on the patient images, in particular ultrasound images. The marker points facilitate merging of images of different origins and / or planning further steps.

[0219] The computing unit can propose a target region for needle insertion based on a patch set by the user and / or based on the patient’s anatomy and / or based on the steps of the medical operation.

[0220] The trajectory of the implant describes the path the implant takes between the access site and the target site. The trajectory can be rendered on the patient image, e.g. on the digital twin. The trajectory can be visualized from different perspectives, e.g. from outside the instrument or from the tip of the instrument. The trajectory can be visualized in a two- or three-dimensional representation.

[0221] The information about the passage of the implant through the predefined region can comprise a detailed representation of the predefined region and can allow planning and / or monitoring of the procedural steps through the region, e.g. through a valve.

[0222] Critical steps of the medical procedure and critical regions of the patient can be associated with a higher risk level and can require a higher level of attention. Critical regions can comprise specific patient characteristics such as vessel calcification, thin vessel walls or vessel bulging. Critical procedural steps can comprise difficult maneuvers and / or complex tool handling.

[0223] The patient’s parameters can comprise measured physiological parameters such as blood pressure, temperature, flow curves or pulse oximetry. The patient’s parameters can comprise real-time measurements of the stomach. The parameters can be determined by the computing unit from information provided by sensors.

[0224] The environmental data can comprise data measured outside the patient such as temperature, ventilation parameters or treatment parameters, e.g. balloon pressure.

[0225] The information about critical events can comprise warning signals, e.g. displayed in case of an unplanned event such as a deterioration of the patient’s vital signs, a system failure or an unexpected movement of the patient.

[0226] The respective information can be computed by the computing unit and / or can be extracted from stored data and / or can be input by the operator.

[0227] The information about the requested input and / or action can comprise an invitation to issue a stop, change or continue instruction such as a simple go / no-go input or a proposal for changing the level of autonomy.

[0228] The information about the requested action can comprise a proposal for interaction with the patient, e.g. requesting the patient to swallow or to breath.

[0229] The computing unit can be adapted to process the user instruction, in particular the change instruction, and to compute possible consequences, e.g. to predict further procedural steps and / or the implications of the further procedural steps, and to evaluate the respective instruction and / or the respective consequences. The computing unit can be adapted to send the computed consequences to the output interface, in particular to display the risks associated with the respective instruction to the operator.

[0230] The output interface can preferably provide a 2D or 3D presentation of the animation from different perspectives, giving the possibility of interaction with the user, for example setting markers for highlighted regions of interest.

[0231] In the 2D or 3D presentation of the animation, the path and / or the tool in advancement and / or the tool in action can be displayed in relation to the image of the patient.

[0232] The computing unit and / or the output interface can combine information from different sources and can for example overlay computed or input data and ultrasound or X-ray images.

[0233] The computing unit can be adapted to change the 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.

[0234] The system can comprise at least one actuator.

[0235] The system can comprise at least one medical tool in operative connection with the actuator. The tool is in particular selected from the group of:

[0236] a puncture needle,

[0237] a dilator,

[0238] a guide,

[0239] a guide wire,

[0240] a catheter, preferably with a pre-mounted implant,

[0241] an endoscopic device, in particular a growth-type robot,

[0242] an imaging device, and

[0243] a closure unit.

[0244] The dilator can comprise a balloon for dilating a blood vessel, a native valve, dilating and / or shaping an implant.

[0245] The closure unit can comprise a suturing device.

[0246] The system can comprise at least one actuator for operating a surgical robot. The system can comprise at least one surgical robot.

[0247] The system can comprise a sensor interface for communicating with at least one imaging device, such as a camera, an endoscope, an ultrasound device, an MRT device or an X-ray device.

[0248] Via the sensor interface, the system can be connected or connectable to the imaging device.

[0249] The system can comprise an imaging device, in particular an imaging device being part of or attached to the surgical robot.

[0250] The system can use data of the imaging device, for example during automatically implemented operational steps, such as steps to find a position for positioning the surgical robot relative to a table or a patient, or steps to find a marked position on the patient, for example a puncture position, or steps to determine a puncture direction based on ultrasound data of an artery.

[0251] The system can comprise a mobile robot cart for carrying the operational unit comprising the user interface and the computer unit, and / or the surgical robot. The computer unit can be adapted to control the mobile robot cart. The mobile robot cart can comprise a separate control unit allowing to drive the mobile robot cart. The mobile cart can follow the operator into the operating room.

[0252] The surgical robot, in particular the mobile cart, can be in an "on" mode, an "off mode or a "standby" mode. In the "standby" mode, the surgical robot can be directly manually moved. The computer unit can be adapted to switch between the "on" mode, the "off mode or the "standby" mode.

[0253] The invention also provides a method for autonomously implementing at least one step of a medical operation comprising at least one step.

[0254] The method is preferably performed using the system as described above.

[0255] The method comprises the step of autonomously controlling, by the computer unit, the operation of the actuators for operating the surgical robot to implement at least one step of the medical operation.

[0256] The method further comprises receiving, by the computer unit, a control instruction in the form of one of a change instruction, a stop instruction and a continue instruction from the user interface.

[0257] The method further comprises causing, by the computer unit, a change operation, a deceleration operation, an acceleration operation, a hold operation, a stop operation or a continue operation of the actuators based on the control instruction as described above.

[0258] The medical operation can be divided into a plurality of separate steps, wherein the method can comprise automatically requesting an input of said control instruction before, during and / or after at least one step.

[0259] When the medical operation is divided into a plurality of separate steps, the computer unit can run in an autonomous mode and fully controls the operation of the actuators to implement at least one step of the medical operation.

[0260] Additionally or alternatively, the computing unit can be operated in a full de-escalation mode. The full de-escalation mode can be a manual de-escalation mode, in which the computing unit releases the actuator for at least one step of the medical operation. The full de-escalation mode can be a teleoperated de-escalation mode, in which the computing unit controls the actuator for at least one step of the medical operation based on teleoperator control instructions provided by the user.

[0261] Additionally or alternatively, the computing unit can be operated in a partial de-escalation mode, in which the computing unit controls the operation of the actuator based on a communication with the user to perform at least one step of the medical operation.

[0262] As mentioned above, the partial de-escalation mode can comprise different levels of the partial de-escalation mode, depending on the degree of influence of the user on the computing unit.

[0263] The method can comprise switching between the autonomous mode, the full de-escalation mode and / or the partial de-escalation mode.

[0264] There can also be switching between the different levels of the partial de-escalation mode.

[0265] The computing unit can automatically switch from the autonomous mode to the partial de-escalation mode and / or the full de-escalation mode, or from the partial de-escalation mode to the full de-escalation mode. In this context, automatically means that in the respective mode the computing unit verifies whether the conditions for continuing operation in the respective mode are fulfilled. If not, the computing unit switches to a mode with lower autonomy by itself.

[0266] The method can comprise switching between the modes according to a predetermined hierarchical model.

[0267] In particular, the computing unit can only switch to the next most proximate level of autonomy. The computing unit can automatically switch to a mode with lower autonomy and the computing unit can require control instructions from the user to switch to a mode with higher autonomy.

[0268] In particular, after one intervention step is performed, the transition from one level to another is only possible autonomously from the fully autonomous level to the semi-autonomous level. The system then waits for human input to validate and initiate the next intervention step. The transition from the semi-autonomous level back to the fully autonomous level can only be done after human input.

[0269] The transition from all other levels to a level proximate level is preferably only done with human input.

[0270] If there is no emergency, the computing unit can switch to the most proximate level with lower autonomy and wait for input / instructions. Preferably, the computing unit cannot switch to a higher autonomy level by itself.

[0271] Preferably, the human user can activate the emergency mode at any time, in any mode.

[0272] For safety reasons, the system can be able to detect and signal an anomaly constituting an emergency, in which case the system can pause and wait for instructions or direct human intervention.

[0273] The computer unit can request control instructions from the user before switching to the autonomous mode, or before switching from the fully degraded mode to the partially degraded mode. Thus, preferably, the computer unit only changes to a mode with higher autonomy if the user allows it.

[0274] The computing unit can receive control instructions regarding at least one of the following: an access point into the patient's body, a position of the surgical robot relative to the access point for accessing the patient's body, an implant position, a speed and trajectory of implant insertion, a position and / or orientation of the implant, deployment parameters for deploying the implant, in particular a balloon pressure for expanding the implant, a direction and speed of the instrument during instrument retraction, and operating an imaging device, in particular an endoscopic camera, a checklist of steps of the intervention and / or a to-do list.

[0275] The control instructions can include detailed information and can be used directly to control the actuators. The control instructions can also direct the computer unit to determine corresponding data for controlling the actuators. The user can specify the access point, the position of the surgical robot, the position of the implant, etc., or the computer unit is adapted to determine and / or change the access point, the position of the surgical robot, the position of the implant, etc.

[0276] The method can be adapted for endoluminal operations.

[0277] In general, the computer unit can plan and / or execute at least one step of the medical operation. To plan and execute the steps, the computer unit can use AI software.

[0278] The computing unit can receive data, for example regarding the patient's anatomy and state, technical options and environmental conditions, can determine parameters for controlling the medical operation steps, in particular based on these data, and can control the surgical robot based on the determined parameters. The computer unit can provide intermediate results, can report the ongoing steps to the user, and can require confirmation.

[0279] The method can be adapted for endoluminal operations to intervene in a body tube or cavity, such as a TAVI operation, a weight loss operation, a bronchial alveolar operation, a ureter-bladder operation or a vaginal-uterine operation.

[0280] The computing unit can control at least one of the following: a pre-operative step, a planning step, a robot movement step, a navigation step for moving the valve from an access point to a target position, an intermediate step, a valve placement step, and a closure step, as described above.

[0281] The method can also be adapted for a weight loss operation, and the computing unit can control at least one of the following: a pre-operative planning step for weight loss, a robot positioning step for weight loss, a navigation step for weight loss, an implant landing step for weight loss, an implant deployment step for weight loss, and a retraction step for weight loss, as described above.

[0282] The method can also be adapted for a bronchial alveolar operation, and the computing unit can control at least one of the following: a pre-operative planning step for bronchial alveolar, a robot positioning step for bronchial alveolar, a navigation step for bronchial alveolar, an implant landing step for bronchial alveolar, an implant deployment step for bronchial alveolar, and a retraction step for bronchial alveolar, similar to the weight loss operation as described above.

[0283] The method can also be adapted for a ureter-bladder operation, and the computing unit can control at least one of the following: a pre-operative planning step for ureter-bladder, a robot positioning step for ureter-bladder, a navigation step for ureter-bladder, an implant landing step for ureter-bladder, an implant deployment step for ureter-bladder, and a retraction step for ureter-bladder, similar to the weight loss operation as described above.

[0284] The method can also be adapted for a vaginal-uterus operation, and the computing unit can control at least one of the following: a pre-operative planning step for vaginal-uterus, a robot positioning step for vaginal-uterus, a navigation step for vaginal-uterus, an implant landing step for vaginal-uterus, an implant deployment step for vaginal-uterus, and a retraction step, similar to the weight loss operation as described above.

[0285] The computing unit can determine a risk parameter related to the change based on the change instruction input via the change interface. The computing unit can compare the risk parameter to a predefined risk category, e.g. a risk level, and react according to the comparison. For example, if the risk is too high, the computing unit can request a confirmation and / or a new control instruction, and / or can stop operating the actuator, and / or can switch to a lower level of autonomy.

[0286] The computing unit can receive a user input and / or a user change, can compute a next step based on the user input, and can send the result of the computation to the output interface. The computing unit can also evaluate a risk related to the result, and the output device can show the result together with the related risk.

[0287] The computing unit can provide to the output interface information selected from the group of information on the current step implemented by the system and / or on the next step to be implemented by the system, information on the check list and / or on the to-do list, information on the digital twin, information on the simulated operation, information on the marked points on the patient image, information on the target area of the needle, information on the planned and / or actual trajectory of the implant, information on the passage of the implant in the predefined area, information on the critical areas, information on the planned or actual instrument retraction, and information on the physiological and / or pathological parameters of the patient and / or on the environmental data, information on the requested inputs and / or actions, as described above.

[0288] The information provided to the output interface can inform the user of all the actions performed by the robot (preferably in real time view), of all the actions to be performed after the current step and / or of all the steps already performed.

[0289] The output unit can provide a final report on the medical operation, can indicate which steps have which level of autonomy, and / or can provide an evaluation of the performed steps.

[0290] The computing unit can control at least one medical tool in operative connection with the actuator, in particular selected from the group of puncture needle, dilator, introducer, guide wire, catheter, preferably with pre-mounted implant, imaging device, endoscopic device, in particular a growing robot, and closing unit. A growing robot, for example as disclosed in EP 4066724 A1, makes use of a robot body expansion to move and interact with the environment.

[0291] The present application also provides a computer program comprising program code for implementing the steps of the method as 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.

[0292] The present application also provides a computer program product, which can be directly loaded into the internal memory of a digital computer and comprises software code portions which, when the program is run on a computer, carry out the steps of the method as described above, wherein preferably the software code is adapted to access a pre-trained neural network and / or artificial intelligence software. BRIEF DESCRIPTION OF DRAWINGS

[0293] The present application will be better understood with reference to the following description of preferred embodiments and to the attached drawings, in which:

[0294] Figure 1 is a schematic view of a first embodiment of a system according to the present application;

[0295] Figure 2 is a schematic representation showing an example of the components of the system and their connections;

[0296] Figure 3 is a schematic view of a second embodiment of a system according to the application;

[0297] Figure 4 is a schematic diagram showing steps of a TAVI operation;

[0298] Figure 5 is a schematic flowchart showing sub-steps of the robot movement step and the puncture step;

[0299] Figure 6 is a schematic flowchart showing detailed sub-steps of the robot movement step;

[0300] Figure 7 hierarchical models for different modes are schematically shown. DETAILED DESCRIPTION

[0301] Figure 1 is a schematic view of a first embodiment of a system 1 for autonomously performing a medical operation comprising at least one step. The system 1 comprises a user interface 2 for inputting user instructions, a computing unit 3 and an interface 4 for communicating with at least one actuator 5 for operating 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 the medical operation.

[0302] The computing unit 3 is adapted to receive control instructions in the form of change instructions, stop instructions and continue instructions from the user interface 2 to cause a change operation, a stop operation or a continue operation of the actuator 5 based on the control instructions.

[0303] The actuator 5 allows operating different medical tools 10 in connection with the surgical robot 6. The interface 4 cooperates with the actuator 5 via a wired connection 16 to send control signals to the surgical robot 6 and to receive signals that can be processed by the computing unit 3. For example, the computing unit 3 can generate signals to be displayed on a display of the user interface 2.

[0304] The system 1 comprises a memory 3a that allows storing information about the operation steps, risk levels in connection with the operation steps and information about the patient, for example data related to the patient's anatomy.

[0305] Figure 2 is a schematic representation showing an example of system components and their connections.

[0306] The system 1 can comprise a UI (user interface) laptop connected via USB connection to a gamepad and a LOG camera. The UI laptop and a US (ultrasound) laptop coupled to a US (ultrasound) beamformer via an Ethernet connection to a central router.

[0307] UI laptops and game controllers can be used as user interfaces for inputting user commands and as displays for monitoring medical procedures.

[0308] The router can also be connected to a switch via Ethernet, which can be coupled to an Eth2USB and a micro PC via Ethernet. The Eth2USB is associated with a robot controller connected via USB, and the micro PC in this case is a NUC. An Ethernet connection can also exist between the micro PC and the robot controller.

[0309] The micro PC can connect via USB to an access subsystem that includes a load cell, sensor, and motor controller. Additionally, the micro PC can connect to a fixed camera and / or an mounted camera.

[0310] A micro PC and robot controller can be used as computing units, adapted to perform at least one step of a medical procedure by autonomously controlling the operation of actuators via a robot.

[0311] Figure 3 This is a schematic view of a second embodiment of System 1.

[0312] The system includes an operating unit 12 with a computer 11. The computer 11 includes a computing unit (not explicitly shown) and a monitor 13, which provides a user interface 2 and an output interface 9.

[0313] Computer 11 includes a verification interface 2a with a gaze tracker and a change interface 2b, in which case change interface 2b is a remote operation console that includes a joystick, buttons, and a hand motion tracker.

[0314] System 1 further includes a surgical robot 6 having a robotic arm 14 that communicates with a computer 11. The surgical robot 6 includes an emergency stop device 8 for immediately stopping any surgical procedure upon activation of an emergency stop button.

[0315] The surgical robot 6 includes a mobile robot cart 15 that autonomously moves the surgical robot 6 to the operating site.

[0316] Figure 4 This is a schematic diagram illustrating the steps of a TAVI procedure. The TAVI procedure includes preoperative steps 21, planning steps 22, robot movement steps 23, access steps 24, navigation steps 25, intermediate steps 26, valve placement steps 27, and closure steps 28.

[0317] During preoperative step 21, a three-dimensional image of the relevant vascular system is reconstructed based on an imaging process, such as a computed tomography scan combined with a contrast agent, and / or a vascular map is generated.

[0318] A digital twin of the patient can be constructed. This digital twin can be displayed.

[0319] During the planning step 22, the puncture position and / or the access point is determined. The computing unit proposes a path through the vascular system, an implant valve type, an implant valve size and a specific implant valve position. The operator can verify the respective proposals or can change the selection. The computing unit can check the consequences of the manual selection. Subsequently, the computing unit can verify the selection or can return a warning or an alternative proposal.

[0320] During the robot movement step 23, the surgical robot 6, in particular the robot arm 14 (see Figure 2 ), is moved into a position and orientation to perform the surgical operation, for example as disclosed in EP 22315330.5.

[0321] To bring the surgical robot 6 into the operating position, the access patch can be detected and the robot cart 15 can place the surgical robot 6 such that the robot arm 14 can reach the access patch.

[0322] During the access step 24, the artery is detected, a suitable needle is selected, the needle is placed and the patient is punctured. Afterwards, a guide is placed at the access point, if necessary with the aid of a dilator.

[0323] Once the femoral artery bifurcation, for example, is detected, the target of the needle can be about 1-2 cm before the bifurcation, ideally with minimal calcification.

[0324] The actions on the patient are performed by the robot arm 14 under control of the computing unit 3. The computing unit 3 can autonomously plan and perform all sub-steps of the puncture step, with guidance by the user or verification by the user. During the navigation step 25, a guide wire is guided from the access point through the vascular system into the heart. The implant valve is guided through the guide and along the guide wire from the access point to the heart. If necessary, additional tools are used. For example, if calcified structures have been detected, a balloon can be used to dilate the vessel.

[0325] The computing unit 3 can autonomously plan and perform all sub-steps of the navigation step 25, with guidance by the user or verification by the user.

[0326] At specific anatomical structures, the user can take over control completely or the influence of the user can increase. For example, when passing the aortic arch, control instructions can be requested at additional check points. The movement speed can be reduced in order to give the user the opportunity for further intervention.

[0327] During the intermediate step 26, the valve implant passes through the native valve. This step usually requires a high degree of attention by the operator and can be controlled with a low level of autonomy of the computing unit 3, for example in a full or partial fallback mode.

[0328] It can be necessary to dilate the calcified native valve.

[0329] During the valve placement step 27, the valve implant is transferred into its functional state. The valve implant is properly placed, deployed from the catheter, oriented, dilated, anchored and / or partially or completely released from the catheter. The function of the valve is verified by measuring the pressure gradient and / or by monitoring the flow of contrast agent.

[0330] If necessary, the valve implant can be recaptured and can be reloaded into the catheter and repositioned or removed.

[0331] The computing unit 3 can autonomously plan and conduct all sub-steps of the valve placement step 27, if guided or verified by the user.

[0332] The navigation step 25, the intermediate step 26 and the valve placement step 27 are typically monitored by an imaging system, for example an X-ray system. Additionally or alternatively, local information detected by the robotic arm can be converted into signals to be presented on an output device, for example on a 3d image of the patient and / or digital twin and / or on a virtual reality monitor.

[0333] During the closure step 28, all instruments are withdrawn from the vascular system. The artery is closed, preferably using a closure device. The closure is verified, for example using fluoroscopy and / or ultrasound.

[0334] Each step, and preferably each sub-step, can initially be associated with a predetermined level of autonomy.

[0335] Figure 5 is a schematic flow chart showing the sub-steps of the robotic motion step 23 and the access step 24. The sub-steps can start when the surgical robot has reached its intended position.

[0336] In step 101, the system checks whether the system is in a ready state. The user can verify the ready state.

[0337] In step 102, the robotic arm is put in a home configuration. The user can verify the home configuration.

[0338] In step 103, patches are searched according to patch search end conditions, for example defining that at least one patch must be detected, for example as disclosed in EP22315330.5.

[0339] To search for patches, a motion step 104 can be repeated, wherein the robotic arm with the patch detection unit is moved multiple times until at least one patch is detected.

[0340] Once the patch is detected, the path of the mobile access tool to the access point is defined in step 105. Other paths can be planned in step 106, for example as long as the final path is not validated by the user.

[0341] In step 107, the path is executed, which means that the tool is positioned above the patch.

[0342] In step 108, the tool is moved towards the patient until contact with the patch.

[0343] In step 109, a search is performed by the ultrasound probe to scan the skin until the axial position of the artery is detected.

[0344] In step 110, the center of the artery can be manually entered.

[0345] Optionally or additionally, in step 111, the search can be repeated.

[0346] In step 112, the skin is scanned along the axis of the artery towards the bifurcation until the bifurcation is detected. If needed, in step 113, the center of the bifurcation is manually entered.

[0347] In step 114, the ultrasound probe is rotated by 90° around the US probe axis in order to switch from an axial view of the vessel to a longitudinal view until the bifurcation is detected longitudinally.

[0348] In step 115, the needle access is identified. The needle access can be identified from the location of the femoral bifurcation and / or the location of the femoral head.

[0349] The puncture can be based on the location of the femoral bifurcation only, or can be based on the location of the femoral head, or can use both in combination to achieve stronger algorithm robustness and patient safety.

[0350] The bifurcation or femoral head location can be identified purely by image processing algorithms, purely by deep neural networks, or in combination of both.

[0351] An example of a purely image processing algorithm for detecting the femoral bifurcation can include the following steps.

[0352] First, the femoral artery around the femoral bifurcation region is segmented, for example using a active contour method.

[0353] Second, the centerline (or skeleton) of the femoral artery is extracted, for example using mathematical morphology, and the inner contour of the femoral artery is identified using mathematical rules about the location of the inner contour with respect to the centerline of the femoral artery.

[0354] Then, the inner contour of the femoral artery can be approximately modeled as a tilted Y shape, so that the femoral bifurcation can be directly extracted as the bifurcation point of the Y shape, for example using mathematical morphology rules.

[0355] The combination of deep neural networks for bifurcation detection with image processing can for example comprise segmenting the femoral artery around the bifurcation region using a deep neural network (e.g. 2D Unet).

[0356] Afterwards, the bifurcation can be extracted by subsequent image processing steps as described above.

[0357] A pure deep neural network based on femoral artery bifurcation detection can comprise training a regression deep neural network on images labeled by medical experts in order to directly identify the geometric coordinates of the bifurcation point in the ultrasound image.

[0358] An image processing algorithm for femoral head detection in ultrasound images can comprise detecting the femoral head region with prominent texture using for example adaptive thresholding or clustering algorithms (e.g. K-means) in pixel neighborhoods, and prior knowledge about the shape of the femoral head (e.g. circular) and the relative position with respect to the artery and / or the femoral bifurcation.

[0359] A neural network based femoral head detection can comprise training a segmentation deep neural network (e.g. 2D Unet) trained on a large labeled image dataset. Optionally, using prior knowledge about the shape of the femoral head, a regression deep neural network can be used to fit a parametric shape model (e.g. an ellipse or a higher order shape) onto the femoral head. The latter takes the ultrasound image as input and outputs the parameter vector of the chosen parametric shape model.

[0360] If needed, in step 116, the needle access is identified manually.

[0361] For example, the bifurcation can be detected as shown in co-pending application EP 22315210.9 of the same applicant.

[0362] Once the needle access is identified, in step 117, the needle is moved towards the target.

[0363] In a subsequent step 118, the needle movement is performed until the needle is inserted.

[0364] In step 119, the introducer is inserted. Once the correct insertion of the introducer is verified, the tool can be withdrawn in step 120.

[0365] In a final step 121, the puncturing tool can be brought into a home configuration.

[0366] During all sub-steps, the operator is in a position that can stop, verify, edit and / or intervene at any step. The interaction is via a user interface 2, for example in the form of a graphical user interface (GUI), a virtual reality environment, physical buttons, voice means, gaze tracking means, haptic gloves, etc.

[0367] Figure 6 is a schematic flow chart showing further sub-steps of the robot motion step. The further steps comprise exit points in case the next sub-step cannot be executed.

[0368] For example, after execution of steps 104-107 (see also Figure 5 ) the patch has been detected, the path has been planned and the robot arm has been moved above the patch, it can happen that the patch is lost and can no longer be detected. If the patch is lost, steps 104-107 have to be repeated.

[0369] If the patch is not lost, the next step 108 can be executed and the tool can be moved towards the patch.

[0370] Likewise, it can happen that the patch is lost and can no longer be detected. If the patch is lost at this point, steps 104-108 have to be repeated. Otherwise, the path can be executed.

[0371] If finally the patch can no longer be found, the tool has to be moved away from the skin.

[0372] The movement away from the skin can comprise a movement in the direction of the main axis of the ultrasound probe in Cartesian space. This ensures a linear movement of the ultrasound probe to avoid the patient.

[0373] Once in contact with the patient's skin, the patch detection module is no longer run.

[0374] Figure 7 A hierarchical model for different modes is schematically shown.

[0375] Mode IV corresponds to the lowest level of automation, in which the computer unit is only adapted to signal processing under human control.

[0376] Mode IV corresponds to level 0 as described above. The system, e.g. a surgical robot system, does not perform any steps, but some subsystems can continue to work, e.g. signal processing.

[0377] This mode can be employed in emergency situations.

[0378] Mode III is associated with a reduced autonomy. The user has direct control over the physical device.

[0379] Mode III corresponds to levels 1-2 as described above. The surgeon either teleoperates or specifies, through physical interaction, places and / or moves the surgical robot to a region of interest, after which the surgical robot can execute a sequence of steps. The positioning can be enabled by superimposing, e.g. ultrasound images of detected blood vessels or other anatomical features.

[0380] Mode II is related to the semi-autonomous level, where the agent is fed by GUI input.

[0381] Mode II corresponds to level 3 as described above. The surgical robot can have an overall plan of what to do and / or what to achieve or detect. Necessary information, e.g. about the bifurcation of the femur, the suture point, can not be available to the surgical robot or can not be accessible to the surgical robot. The surgeon can provide the required input, e.g. via a GUI, after which the surgical robot can continue.

[0382] Mode I corresponds to fully autonomous control under supervision of the user.

[0383] Mode I corresponds to level 4 as described above, and - assuming confirmation of the robot to continue does not constitute human input / help - also to level 5.

Claims

1. A system (1) for autonomously performing a medical procedure including at least one step, the system comprising: Calculation 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); The computing unit (3) is adapted to be: Autonomously control the operation of the actuator (5) to perform at least one step of the medical procedure; Receive control commands from the user interface (2) in the form of a change command, a stop command, and a continue command; as well as The control commands trigger changes to the actuator's operation, warning signals, continue signals, stop operations, or continue operations.

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

3. The system according to claim 1 or 2, wherein the computing unit is capable of operating in autonomous mode, fully degraded mode, and / or partially degraded mode, wherein: In autonomous mode, the computing unit (3) has complete control over the operation of the actuator (5); In the degraded mode, the computing unit (3) (i) releases the actuator (5) so that it can be freely and manually operated by the user in the manual degraded mode, or (ii) controls the actuator (5) based on the remote operation control command provided by the user in the remote operation degraded mode.

4. The system according to claim 3, wherein the system includes a switching unit (7) for switching operations between the autonomous mode, the fully degraded mode and / or the partially degraded mode, and / or particularly switching operations between different levels of the partially degraded mode.

5. The system according to claim 4, wherein, The switching unit (7) is controlled by the computing unit (3) in the following manner: The operation can automatically switch from the autonomous mode to the fully degraded mode or the partially degraded mode; and The operation can only switch to the autonomous mode upon user instruction or verification.

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

7. The system according to any one of claims 1 to 6, the system further comprising a change interface (2b) for inputting initiation, modification, continuation, maintenance and / or stop instructions, the change interface (2b) preferably being selected from the group consisting of: Voice interface; Mechanical button or switch; mouse; joystick; Tactile gloves; keyboard; Graphical user interfaces, especially touchscreens; Motion detectors, especially eye trackers or head motion detectors; Eye-to-image interface; Virtual reality or augmented reality interface; 3D monitor.

8. The system of claim 7, wherein the change instruction is selected from the group consisting of: Define the entry point used to access the patient's body; Define the position of the surgical robot relative to the entry point used to enter the patient's body; Define the implant location; Define the speed and trajectory of implant insertion; Define the location and / or orientation of the implant; Define deployment parameters for deploying the implant, particularly the balloon pressure used to expand the implant; Define the direction and speed of the instrument during retraction; Operating imaging devices, especially endoscopic cameras; Define checklists and / or to-do lists.

9. The system according to any one of claims 1 to 8, further comprising a stop interface (2c) for providing a stop command, said stop interface (2c) being selected from the group consisting of: Voice interface; Mechanical button or switch; mouse; joystick; Tactile gloves; keyboard; Graphical user interfaces, especially touchscreens; Motion detectors, especially eye trackers or head motion detectors; Virtual reality or augmented reality interface; 3D monitor; Timer; Button; Devices used to detect risks or unexpected events.

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 adapted to implement the change instruction only when the predefined instruction criteria of the corresponding risk level are met.

12. The system of claim 1, wherein the medical operation is divided into multiple separate steps (21, ..., 29; 101, ..., 115), wherein the system is adapted to automatically request to receive the user instruction before or after the first step or before or after the last step.

13. The system according to any one of claims 1 to 12, wherein the system (1) is adapted for intervention in endocavitary procedures of a body tube or cavity, such as TAVI procedures, weight-loss procedures, bronchoalveolar procedures, ureterocystotomy procedures, or vaginal-uterine procedures, and wherein the steps of said medical procedure include at least one of the following: Preoperative steps (21). Plan steps (22), Robot movement steps (23). Puncture procedure (14). Navigation steps (15) for moving the valve from the approach point to the target location. Intermediate step (26), Valve placement procedure (27). Closure step (28); Pre-operative planning steps for weight loss surgery The positioning steps for a weight reduction robot Weight loss navigation steps, Steps for measuring weight loss volume. Steps to lose weight and shrink the stomach Weight loss safety check procedures Weight reduction volume verification steps, Landing steps for weight-reducing implants Steps for deploying weight-loss implants Weight reduction and recovery steps; Preoperative planning steps for bronchoalveolar surgery Steps for bronchoalveolar robot localization. Bronchoalveolar navigation steps Procedure for measuring bronchoalveolar volume Bronchoalveolar safety inspection procedures Steps for verifying bronchoalveolar volume. Bronchoalveolar implant landing procedures Bronchoalveolar implant deployment steps Steps for bronchoalveolar retraction; Preoperative planning steps for ureterocystostomy Ureterobladder robotic localization steps, Ureterobladder navigation steps, Procedure for measuring ureterocystovolition volume Ureterobladder safety check procedure Ureter-bladder volume verification procedure Ureterobladder implant landing procedures Ureterobladder implant deployment steps, Ureter-bladder retraction procedure; Preoperative planning steps for vaginal-uterine surgery Vaginal-uterine robotic positioning steps Vaginal-uterine navigation steps, Procedure for measuring vaginal-uterine volume Vaginal-uterine safety check procedure Procedures for verifying vaginal-uterine volume Steps for vaginal-uterine implant placement Steps for vaginal-uterine implant deployment Vaginal-uterine retraction steps.

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

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

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

17. The system of claim 16, wherein the output interface (9) is selected from the group consisting of: Optical or visual output interface; Augmented reality displays; Virtual reality display; haptic feedback device; Acoustic output interface.

18. The system according to any one of claims 16 or 17, wherein the computing unit (3) is adapted to provide information selected from the group consisting of the output interface (9): Information regarding the current steps performed by the system and / or the next steps to be performed by the system; Information regarding checklists and / or to-do lists; Information about digital twins; Information regarding the simulation operation; Information about markers on the patient's images; Information about the target area of ​​the needle; Information regarding the planned and / or actual trajectory of the implant; Information regarding the pathway of the implant in a predefined region; Information regarding key areas; Information regarding planned or actual equipment recall; Information regarding the patient's physiological and / or pathological parameters and / or environmental data; Information regarding key events; Information regarding the requested input and / or action.

19. The system according to any one of claims 1 to 18, the system further comprising at least one medical tool (10) operatively connected to the actuator, particularly tools selected from the group consisting of: Puncture needle; Expander; Guide; Guide wire; The catheter, preferably having a pre-installed implant; Endoscopic devices, especially growth robots; and Closed unit.

20. A method for autonomously performing a medical procedure comprising at least one step, preferably utilizing a system according to at least one of the preceding claims, the method comprising: The computing unit (3) autonomously controls the operation of the actuator (5) used to operate the surgical robot to perform at least one step of the medical operation; The computing unit (3) receives control commands from the user interface (2) in the form of a change command, a stop command, and a continue command; and The calculation unit (3) induces the actuator (5) to perform change operation, deceleration operation, acceleration operation, hold operation, stop operation or continue operation based on the control command.

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

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

23. The method of claim 22, wherein the method includes switching between the autonomous mode, the fully degraded mode and / or the partially degraded mode, and / or particularly switching between different levels of the partially degraded mode, especially according to a predetermined hierarchical supervision model.

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

25. The method according to any one of claims 20 to 24, wherein the computing unit (3) receives control instructions regarding at least one of the following: The entry point into the patient's body; The position of the surgical robot relative to the entry point into the patient's body; Implant location; The speed and trajectory of implant insertion; The location and / or orientation of the implant; Deployment parameters used for deploying implants, particularly balloon pressure used to expand implants; The direction and speed of the instrument during retraction; Operating imaging devices, especially endoscopic cameras; This includes a checklist and / or to-do list for intervention steps.

26. The method according to any one of claims 20 to 25, wherein the method is adapted for intracavitary procedures, such as TAVI procedures, weight-loss procedures, bronchoalveolar procedures, ureterocystotomy procedures, or vaginal-uterine procedures, and wherein the computing unit (3) controls at least one of the following: Preoperative steps, Plan steps, Robot movement steps, Navigation steps used to move the valve from the approach point to the target location. intermediate steps, Valve placement procedure, and Closure steps; Pre-operative planning steps for weight loss surgery The positioning steps for a weight reduction robot Weight loss navigation steps, Landing steps for weight-reducing implants The steps involved in deploying weight-loss implants, and Weight reduction and recovery steps; Preoperative planning steps for bronchoalveolar surgery Steps for bronchoalveolar robot localization. Bronchoalveolar navigation steps Procedure for measuring bronchoalveolar volume Bronchoalveolar safety inspection procedures Steps for verifying bronchoalveolar volume. Bronchoalveolar implant landing procedures Bronchoalveolar implant deployment steps Steps for bronchoalveolar retraction; Preoperative planning steps for ureterocystostomy Ureterobladder Robotic Positioning Steps Ureterobladder navigation steps, Procedure for measuring ureterocystovolition volume Ureterobladder safety check procedure Ureter-bladder volume verification procedure Ureterobladder implant landing procedures Ureterobladder implant deployment steps, Ureter-bladder retraction procedure; Preoperative planning steps for vaginal-uterine surgery Vaginal-uterine robotic positioning steps Vaginal-uterine navigation steps, Procedure for measuring vaginal-uterine volume Vaginal-uterine safety check procedure Procedures for verifying vaginal-uterine volume Steps for vaginal-uterine implant placement Steps for vaginal-uterine implant deployment Vaginal-uterine retraction steps.

27. The method according to any one of claims 20 to 26, wherein the calculation unit (3) determines risk parameters related to the change based on the change instruction input via the change interface.

28. The method according to any one of claims 20 to 27, wherein the computing unit (3) provides information selected from the group consisting of the following to the 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 about digital twins Information about the simulation operation. Information about markers on patient images Information about the target area of ​​the needle. Information regarding the planned and / or actual trajectory of the implant. Information about the pathway of the implant in a predefined region. Information about key areas Information regarding planned or actual equipment recalls, and Information regarding the patient's physiological parameters and / or environmental data. Information regarding key events, Information regarding the requested input and / or action.

29. The method according to any one of claims 20 to 28, wherein the computing unit (3) controls at least one medical instrument operatively connected to the actuator (5), particularly selected from: Puncture needle; Expander; Guide; Guide wire; The catheter, preferably having a pre-installed implant; Endoscopic devices, especially growth robots; Imaging devices; and Closed unit.

30. A computer program comprising program code for implementing 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 capable of being directly loaded into the internal memory of a digital computer (11) and comprising a software code portion that, when the program is run on the computer (11), performs the steps of the method according to at least one of claims 20 to 30, wherein preferably the software code is adapted to access pre-trained neural networks and / or artificial intelligence software.

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