User assistance system for navigating medical device

Abstract

The invention relates to a user assistance system (1) for image assistance in navigation of a medical device (4). The user assistance system (1) comprises an imaging system (2) arranged to generate image data that at least partially images the medical device (4) and to display a graphical view of the image data for image assistance in navigation of the medical device (4). Furthermore, the user assistance system (1) comprises a monitoring system (3) arranged to monitor whether there is a movement of the medical device (4). The monitoring system (3) is configured to initiate a risk-reducing first measure (101) when image assistance by the imaging system (2) is deactivated and there is a movement of the medical device (4) as a function of monitoring by the monitoring system (3).

Description

Technical Field

[0001] This invention relates to a user assistance system and method for image-assisted navigation in a medical device. The user assistance system includes an imaging system configured to generate and display image data for image-assisted navigation of the medical device, the image data at least partially imaging the medical device. Background Technology

[0002] In the field of vascular surgery, the demand for minimally invasive interventions continues to grow due to various disease conditions. Endovascular surgery plays a central role here, as it is an essential component of modern vascular surgery in the treatment of peripheral or central arterial occlusive diseases.

[0003] Endovascular surgery is based on the use of medical devices such as guidewires and catheters, which are introduced into a patient's vascular system to diagnose or treat lesions that can be reached through this pathway. For example, these devices, in particular, use angiography C-arm systems to image the patient's body with X-rays to assist the user and / or robotic system in navigating the medical device.

[0004] Clinical applications include cardiology (e.g., treating heart disease by implanting stents), radiology / oncology (e.g., targeted delivery of chemotherapy drugs to tumors in a patient's liver), and neuroradiology (e.g., mechanical thrombectomy for treating ischemic stroke).

[0005] Current research and development focuses on robotic systems for manipulating intravascular devices within a patient's vascular system. Development goals include improving patient safety, standardizing treatment quality and thereby reducing complication rates, and increasing workflow efficiency.

[0006] One risk of endovascular surgery is the potential for injury if medical devices are not optimally positioned or moved within the patient's vascular system. Image-assisted procedures can significantly reduce this risk, leading to more reliable surgical success. Therefore, image-assisted procedures make a crucial contribution to patient safety by providing visualization and control over the positioning of medical devices. Without this control, uncontrolled movement of the medical device could result in injury. Summary of the Invention

[0007] The technical problem to be solved by this invention is to further reduce the risk of uncontrolled and / or suboptimal movement of medical devices.

[0008] The technical problem is solved by a user assistance system for image assistance in navigation of medical devices and a method for image assistance in navigation of medical devices by displaying a graphical view of image data generated by an imaging system.

[0009] The present invention is based on the concept that once movement of a medical device is detected but active imaging is not activated, risk reduction measures are initiated.

[0010] In a first aspect of the invention, a user assistance system for image-assisted navigation of a medical device is proposed. This user assistance system includes an imaging system, particularly a medical imaging system, configured to generate image data and, particularly, display a graphical view of the image data on a display unit for image assistance in navigation of the medical device, the image data at least partially imaging the medical device. Furthermore, the user assistance system includes a monitoring system configured to monitor for the presence of movement of the medical device. The monitoring system is configured to initiate a first risk mitigation measure when image assistance via the imaging system is deactivated and, based on monitoring by the monitoring system, movement of the medical device is simultaneously present.

[0011] In other words, the monitoring system can monitor the status of image assistance, specifically whether it is activated or deactivated by the imaging system, and also monitor the movement of the medical device. Once image assistance is deactivated, specifically when no image data is output, and movement of the medical device is detected simultaneously, the first risk mitigation measure can be initiated. This can occur either first, when the first condition—image assistance being deactivated—or first, when the second condition—movement of the medical device—is detected. In some embodiments, this first measure may vary according to its order, but in others it may be independent of the order.

[0012] Risk reduction measures can be understood in particular as measures to reduce the risk of injury caused by uncontrolled or accidental movement of medical devices. Such risk reduction measures may include, for example, issuing warnings to the user, disabling the mobility of the medical device, activating or reactivating image-assisted intervention, or other measures that can establish or restore normal operation for intervention.

[0013] Normal operation can be understood as the operation of an imaging system that generates image data, such as continuously, repeatedly, or periodically generating image data and providing or displaying a graphical view of that image data, enabling the user to recognize the image of the medical device in the context of its environment. In this case, the movement of the medical device can be carried out in a low-risk or particularly risk-free manner.

[0014] The monitoring system is configured to monitor the movement of the medical device. This monitoring can be continuous, at regular time intervals, periodically, or repeatedly. Specifically, the monitoring can detect movement only when the medical device has moved a minimum distance within a unit of time. For example, movement below this threshold can be ignored. This effectively avoids frequently triggering first-aid measures when the risk of injury can be largely eliminated.

[0015] Navigation here is understood as the targeted movement of a medical device along a path. The destination may be at least one predetermined area that the medical device should be able to reach. At least a portion of the path may be clearly visible to the user, for example, only with the aid of images. Parts of the path may be particularly unknown to the user and / or new destinations may appear along the path.

[0016] Navigation can be manually triggered or executed by the user through direct movement of the medical device. Alternatively, the robotic system can control the navigation of the medical device and automatically trigger movement via, for example, at least one actuator. As an alternative or additional option to automation, the navigation of the medical device can be controlled from a remote workstation, such as one located in a different room from the medical device. This control can also be referred to as remote operation.

[0017] The deactivation of image assistance can have various causes. For example, it may involve a malfunction of the imaging system. This malfunction could be, for instance, a failure in generating image data, a failure in displaying a graphical view of the image data, or other malfunctions that prevent the imaging system from functioning properly. Similarly, it could involve a malfunction of a component of the imaging system. In other words, image assistance via the imaging system does not necessarily have to be completely deactivated in order to initiate the first measure. It is also possible that the detection or processing of data, especially the raw data required to generate image data, is deactivated or malfunctions. Similarly, the display unit may be deactivated or malfunctions. Likewise, errors or deactivated communication paths with the robot system can lead to the deactivation of image assistance.

[0018] The deactivation of image-assisted features can also be triggered, for example, by intentional actions by the user.

[0019] Alternatively, a partial or complete shutdown of the imaging system may also be involved. This partial or complete shutdown may be triggered by the user, or caused, for example, by a power supply voltage failure or other malfunction of the imaging system. A partial shutdown may also affect components of the imaging system configured to display a graphical view of image data, such as display units, particularly monitors. Therefore, by monitoring the described state of the imaging system through a monitoring system, and by enabling it to trigger the first action in conjunction with movement of the medical device.

[0020] The first measure may include, for example, outputting a warning message, which may be specifically targeted at the user of the user assistance system.

[0021] The user assistance system may, for example, include at least one actuator in some embodiments, and thus have an active influence on the movement of the medical device. Such a user assistance system may be a robotic system, particularly a medical robotic system or an intravascular robotic system. The first measure may also include deactivating the at least one actuator, thereby terminating the movement of the medical device. The first measure may also specifically correspond to deactivating the at least one actuator.

[0022] Because medical devices are located close to users or patients, there is a risk associated with device movement. This risk is particularly high when movement occurs without providing feedback to the user via image-aided methods, preventing the user from taking corrective action. Such movement can lead to unintended effects, erroneous or suboptimal positioning of the medical device, or even injury to the user or patient.

[0023] The medical device may be, for example, an intravascular device, or the medical device may include one or more intravascular devices. The intravascular device may be at least partially located within the body of a person or animal, particularly within a vascular structure or hollow organ. Unintended movement of the intravascular device may, for example, cause perforation of the vessel wall or rupture of an aneurysm. Similarly, such movement may cause other injuries, which may also be caused by portions of the medical device that are not located within the body of the person or animal. The user assistance system may include the medical device in some embodiments.

[0024] The object can be, for example, a patient or a part of a patient's body. The patient can be positioned on a patient bed within the imaging system. The medical device can be located within or partially within the object.

[0025] The image data can be one or more X-ray projection image data, such as multiple X-ray projection image data from different viewpoints. Similarly, the graphical view of the image data can be a three-dimensional reconstruction or a partial three-dimensional reconstruction, particularly a three-dimensional reconstruction or a partial three-dimensional reconstruction from cone-beam computed tomography, digital volumetric tomography, or tomography synthesis. Alternatively, the image data can also be from real-time magnetic resonance imaging (MRI).

[0026] One advantage of this invention is that it minimizes the risk of consequences that could arise from the uncontrolled movement of the medical device. This is particularly relevant when the medical device is used in areas not visible to the naked eye, where users may rely on image-based assistance. If such image assistance becomes unavailable or no longer available, an initial measure, such as warning the user, is triggered as soon as the medical device moves. Similarly, escalation measures can be defined by preventing further movement of the medical device. This improves the fault tolerance of the navigation and increases its success rate.

[0027] Monitoring systems may include, for example, data processing systems. In this disclosure, the terms "data processing system" and "at least one data processing device" are used interchangeably. A data processing device can be particularly understood as a data processing device including processing circuitry. Therefore, such a data processing device can particularly process data to perform computational operations. This may also include performing operations that index and access data structures, such as look-up tables (LUTs).

[0028] Data processing devices may in particular include one or more computers, one or more microcontrollers and / or one or more integrated circuits, such as one or more application-specific integrated circuits (ASICs), one or more field-programmable gate arrays (FPGAs), and / or one or more system-on-a-chip (SoCs). The data processing device may also include one or more processors, such as one or more microprocessors, one or more central processing units (CPUs), one or more graphics processing units (GPUs), and / or one or more signal processors, especially one or more digital signal processors (DSPs). The data processing device may also include a physical or virtual combination of computers or other mentioned units.

[0029] In various embodiments, the data processing device includes one or more hardware interfaces and / or software interfaces and / or one or more storage units.

[0030] The storage cell can be configured as volatile data memory, such as dynamic random access memory (DRAM) or static random access memory (SRAM), or as non-volatile data memory, such as read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory or flash EEPROM, ferroelectric random access memory (FRAM), magnetoresistive random access memory (MRAM), or phase-change random access memory (PCRAM).

[0031] According to at least one embodiment, the imaging system is configured as a medical imaging system for imaging medical devices in organs and / or tissues.

[0032] Here, the imaging system can specifically image at least a portion of the medical device, particularly the end portion of the medical device. The medical device may include, for example, guidewires and / or catheters, for example, for endovascular surgery, vascular implants, stents, flow diverters, etc., or combinations of these devices, which may also be referred to as a device stack.

[0033] Medical devices can be located in organs and / or tissues of a human or animal body at the time of imaging, especially in hollow organs.

[0034] Medical imaging systems can be, for example, X-ray systems, fluoroscopy systems, angiography systems, magnetic resonance imaging systems, or ultrasound systems, or the medical imaging system may include one or more of these imaging modalities. Particularly, it is possible to locally image portions of a human or animal body in which the medical device is located at a given point in time.

[0035] One advantage of this implementation is the precise display of medical devices through the medical imaging process. In particular, it can display areas of the human or animal body that are difficult or impossible to identify without such a medical imaging process. Therefore, the medical imaging process also enables image-assisted navigation of medical devices within organs, especially hollow organs.

[0036] According to at least one other embodiment, the monitoring system is configured to check whether the image content of the image data and / or the image content of the graphical view of the image data conforms to a preset standard. Furthermore, the monitoring system is configured to initiate a second risk mitigation measure when the image content does not meet the preset standard and movement of the medical device is simultaneously detected by the monitoring system.

[0037] In other words, the data processing system can check whether the image content of the image data and / or the image content of the graphic view of the image data conforms to the preset standard. To this end, the data processing system can, for example, be configured to obtain image data from the imaging system and analyze the image content and / or perform image processing.

[0038] The preset standard here may, for example, be a predetermined quality standard for the image content of the image data and / or the graphical view of the image data. This quality standard may, for example, depend on signal-to-noise ratio, contrast, image resolution, image sharpness, absence of artifacts, and / or absence of distortion. A specification here may, for example, be the ability to clearly identify the medical device in an environment immediately adjacent to it, particularly, for example, against a vascular background. These quality standards may be particularly important when the medical device is a small or very small structure, such as a guidewire.

[0039] Alternatively or additionally, the predetermined standard may also involve checking the presence of a medical device. In other words, a requirement could be that the medical device or a predefined portion of the medical device is shown in the image content, i.e., specifically imaging relevant parts of a human or animal body. Here, for example, the medical device can be selected from a list of medical devices, thus enabling the standard to be determined based on the shape of the corresponding medical device. In this way, for example, a second measure can be initiated when the medical device is not identifiable or cannot be clearly identified in the image content and is in motion.

[0040] The second measure may also include the possibilities already described for the first measure, in particular outputting a warning message and / or disabling at least one actuator. The second measure may be the same as or different from the first measure.

[0041] Considering pre-defined criteria has proven particularly advantageous in situations where image assistance is activated, but due to degraded image quality or other reasons, medical devices cannot be objectively identified, or can only be identified to a limited or vague degree. This, for example, can prevent uncontrolled movement caused by a lack of information in the image content.

[0042] According to at least one other embodiment, the user assistance system includes a gaze detection system configured to detect the user's gaze direction. Furthermore, the monitoring system is configured to initiate third and / or fourth risk reduction measures based on the detected gaze direction.

[0043] In other words, a gaze detection system includes, for example, a camera pointed at the user's location. This could be, for example, a workstation set up for using a user assistance system. The camera can be configured to detect images of the user's face and, in particular, identify the eyes. The direction of the gaze can be identified based on the direction of the pupils. The gaze detection system can, for example, be configured for other image processing. This gaze detection system can also be referred to as an eye tracker.

[0044] Other image processing in this gaze detection system may be part of or coupled to a data processing system. This image processing may, in particular, be configured to analyze images of a face, identify eyes in the images, and determine the user's gaze direction.

[0045] In particular, pre-calibration performed at a preset camera position can clearly detect the user's gaze direction and, for example, assign it accordingly to other objects also located in the predetermined position. Therefore, a display unit, such as a graphical view for displaying image data for image assistance, especially a monitor, can be located at this predetermined position, and the gaze detection system can detect whether the display unit is within the user's gaze direction.

[0046] One advantage of this implementation is the ability to check the user's attention. Eye direction, for example, can be used to infer user behavior and lead to targeted warning messages and / or deactivation of the medical device, which can be helpful for the user during navigation.

[0047] According to at least one other embodiment, the monitoring system is configured to initiate a third risk reduction measure when the gaze detection system fails to detect the user's gaze direction and the medical device is simultaneously moving according to the monitoring system's surveillance; or the monitoring system is configured to initiate a third risk reduction measure when the user's gaze direction cannot be detected by the gaze detection system and the medical device is simultaneously moving according to the monitoring system's surveillance.

[0048] In other words, a third measure can be initiated when the gaze detection system fails to detect the user's face, eyes, or pupils, and there is movement of the medical device. This could be due to the user being out of position, having their back to the gaze detection system (e.g., a camera), or the user's face or pupils being undetectable in a localized area of ​​the image.

[0049] The third measure may also include the possibilities already described for the first measure, particularly outputting a warning message and / or disabling at least one actuator. This third measure may be the same as or different from the first measure. If the second measure is provided, the third measure may be the same as or different from the second measure.

[0050] One advantage of this implementation is that it ensures the correct use of the user assistance system. For example, the location of the display unit can determine where the user might operate the user assistance system. In this location, the gaze detection system is able to detect the direction of the gaze. Failure to detect the gaze direction may indicate improper use and could lead to uncontrolled movement of the medical device. This can be avoided by this implementation.

[0051] According to another embodiment, the user assistance system includes a display unit configured to display a graphical view of the image data.

[0052] According to another embodiment, the monitoring system is configured to activate a fourth risk reduction measure when the gaze detection system determines that the user's gaze is not directed at the display unit and the medical device is simultaneously being moved according to the monitoring system.

[0053] The gaze detection system may include, for example, a camera configured to detect the user's gaze direction by analyzing images of the user's face or pupils. The camera may be positioned above a monitor to detect images at the workstation.

[0054] The fourth measure may also include the possibilities already described for the first measure, particularly outputting a warning message and / or disabling at least one actuator. This fourth measure may be the same as or different from the first measure. If a second measure is provided, the fourth measure may be the same as or different from the second measure. If a third measure is provided, the fourth measure may be the same as or different from the third measure.

[0055] One advantage of this implementation is that it specifically ensures the correct use of the user-assistive system. If the user's gaze is not directed at the display unit, the user may be unable to track the movement of the medical device. This embodiment improves system safety.

[0056] According to another embodiment, the user assistance system includes at least one actuator configured to move the medical device.

[0057] In other words, the user assistance system can trigger or control the automatic movement of the medical device using the at least one actuator. Automatic movement achieved through the at least one actuator can be termed robotics, particularly intravascular robotics. The user can, for example, control the at least one actuator using the user assistance system.

[0058] Movement can also be triggered manually, especially by the user.

[0059] One advantage of this embodiment is that the movement of medical devices can be performed more precisely and reproducibly. Automated movement enabled by robotics also achieves spatial separation between the medical device, for example, located inside a human or animal, and the user. If the movement is controlled by an X-ray radiation-based imaging system, spatial separation allows the user to be largely protected from X-ray radiation.

[0060] According to another embodiment, the user assistance system includes a control device configured to generate at least one control signal to control at least one actuator, in particular to move the medical device automatically. Furthermore, a monitoring system is configured to monitor for movement of the medical device based on the control signal.

[0061] This control device can generate at least one control signal from at least one control signal for each of at least one actuator. This allows each individual actuator to be controlled individually and monitored when necessary.

[0062] In some embodiments, the control device may include a user input device, particularly a switch lever, control lever, or joystick. The control device can then, for example, generate at least one control signal based on an input signal from the user input device, and control at least one actuator via this control signal. Fully automatic sequences are also possible, where the control device generates the at least one control signal even in the absence of an input signal. This may occur, for example, in a predetermined path where individualized adaptation is not required.

[0063] Therefore, the at least one control signal can be, for example, an indication of movement of the medical device. Thus, the monitoring system can determine the movement of the medical device based on the presence of the at least one control signal.

[0064] One advantage of this implementation is the ability to accurately and immediately determine the movement of the medical device. At the point in time that the at least one control signal is generated, if a second condition regarding image assistance exists, one of the measures can be initiated with low or no time delay.

[0065] According to another embodiment, the first measure includes deactivating at least one actuator.

[0066] In other words, the first measure can cause the medical device to stop by disabling at least one actuator, for example, stopping the automatic movement of the medical device.

[0067] The monitoring system can be connected to the control device and configured to disable at least one control signal in the first measure using the control device. Specifically, the first measure enables the control device to stop outputting control signals, or to cause the at least one control signal to move the at least one actuator to a stationary position.

[0068] Similarly, the second, third, and / or fourth measures may include deactivating at least one actuator. Each measure may specifically correspond to deactivation.

[0069] One advantage of this implementation is the ability to selectively stop the movement of the medical device. By activating a first measure or by activating a second, third, or fourth measure, the risk of uncontrolled movement can be avoided by preventing automatic movement. Deactivating at least one actuator can be an escalation step of the first measure, for example, after a warning has not been successfully issued.

[0070] According to another embodiment, the user assistance system includes at least one sensor configured to output a sensor signal based on movement of the medical device. Furthermore, the monitoring system is configured to monitor for movement of the medical device based on the sensor signal.

[0071] At least one sensor may include, for example, at least one accelerometer. This at least one sensor may be connected to or be part of the medical device. The user assistance system may include the medical device in some implementations.

[0072] At least one sensor may also include a camera and / or a motion detector, each configured to detect movement of the medical device and output sensor signals based on that movement. An image signal or video stream from the camera may also be considered as at least one sensor signal.

[0073] Therefore, the at least one sensor signal is, for example, another indication of the movement of the medical device. Thus, the monitoring system is able to determine the movement of the medical device based on the presence of the at least one sensor signal.

[0074] The monitoring system can also receive a combination of at least one sensor signal and at least one control signal, and be configured to monitor the two signals independently of each other.

[0075] One advantage of this implementation is that it can accurately and immediately determine the movement of the medical device, especially when the device can be or is being moved manually by the user.

[0076] According to another implementation, the first measure includes outputting at least one warning signal.

[0077] Similarly, second, third, and / or fourth measures (if configured) may include outputting the at least one warning signal. Each measure may correspond to an output.

[0078] One advantage of this implementation is that it delivers information to the user in a timely manner, thereby further reducing risk and preventing uncontrolled movement of medical devices.

[0079] According to another embodiment, at least one warning signal includes a visual signal, and the user assistance system is configured to display the visual signal.

[0080] In other words, the user assistance system can, for example, be connected to a display unit and configured to output visual signals on that display unit. The display unit can be a monitor, and the visual signal can be, for example, a warning message displayed in the foreground of the monitor. Here, the display unit can, for example, be configured to display a graphical view of the image data generated by the imaging system of the medical device in the background.

[0081] Similarly, visual signals can include or correspond to the flashing of warning lights. Warning lights are particularly important as they can be positioned within the user's field of vision.

[0082] One advantage of this implementation is that it quickly and clearly delivers necessary information to the user. Users can also be specifically reminded to focus on key points to minimize or avoid other risks.

[0083] According to another embodiment, the display unit is configured to display a visual signal at a display position, particularly at the display position of the display unit, which is located in the direction of the user's detected gaze.

[0084] In other words, the display unit can be configured, for example, to display the visual signal as a warning message on a monitor at the location where the user is simultaneously looking. The user assistance system can, in particular, be configured to transmit the gaze direction of the gaze detection system to the display unit. For example, the placement of the display unit can be preset so that the display position of the visual signal aligns with the user's gaze direction. Pre-calibration or adaptation to personalized user behavior or, for example, to a specific workstation may be necessary to find the correct display position.

[0085] One advantage of this implementation is that it delivers necessary information to the user in a targeted and clearly visible manner through visual signals located in the user's line of sight. This reduces the possibility of accidentally ignoring visual signals.

[0086] According to another embodiment, the at least one warning signal includes an auditory signal, and the user assistance system is configured to output the auditory signal.

[0087] The user assistance system can be configured to output the auditory signal in the environment immediately adjacent to the user. The at least one warning signal can include both auditory and visual signals. The auditory signal can, for example, include different tones that are amplified, increased in volume, or made more penetrating due to the frequency of the medical device's movement or the frequency of the at least one warning signal. The auditory signal may also include voice output.

[0088] The at least one warning signal may be specifically for the first, second, third, or fourth measures.

[0089] One advantage of this implementation is that it clearly conveys the necessary information to the user. In particular, it attracts the user's attention, thereby reducing the risk of uncontrolled movement.

[0090] In another aspect of the invention, a method is proposed for image assistance in navigation of a medical device by displaying a graphical view of image data generated by an imaging system, wherein the graphical view at least partially images the medical device. Here, a monitoring system monitors for the presence of movement of the medical device. Furthermore, when image assistance is deactivated and movement of the medical device is simultaneously detected by the monitoring system, a first risk mitigation measure is initiated.

[0091] According to at least one embodiment of the method, the imaging system is configured as a medical imaging system, and the medical device is located in an organ.

[0092] Navigation of the medical device is not, in particular, part of the method according to the invention. Movement of the medical device, etc., is also not part of the method of the invention. The method does not include surgical procedures, as it is only for user assistance.

[0093] Other embodiments of the method according to the invention derive directly from different designs of the user assistance system according to the invention, and vice versa. The various features, corresponding descriptions, and advantages of different embodiments of the user assistance system according to the invention can be similarly applied to corresponding embodiments of the method according to the invention. The user assistance system according to the invention is particularly constructed or programmed to perform the method according to the invention.

[0094] Other features and combinations of features of the present invention are derived from the accompanying drawings and their description, as well as the claims. Other embodiments of the present invention do not necessarily include all the features of any one of the claims. Other embodiments of the present invention may have features or combinations of features not mentioned in the claims. Attached Figure Description

[0095] The present invention will now be described in detail with reference to specific embodiments and corresponding schematic diagrams. In the drawings, elements that are the same or have the same function may be represented by the same reference numerals. Descriptions of elements that are the same or have the same function may not necessarily be repeated in different drawings.

[0096] In the attached diagram:

[0097] Figure 1 A schematic diagram illustrating an exemplary embodiment of the user assistance system according to the present invention is shown;

[0098] Figure 2 A block diagram illustrating another exemplary embodiment of a user assistance system for image-assisted navigation in a medical device, according to the present invention, is shown; and

[0099] Figure 3 A block diagram of another exemplary embodiment of a user assistance system for image-assisted navigation in a medical device, according to the present invention, is shown. Detailed Implementation

[0100] exist Figure 1 An exemplary embodiment of a user assistance system 1 according to the present invention is illustrated schematically. The user assistance system 1 has an imaging system 2 configured to generate a graphical view of image data of an object 10, wherein the graphical view at least partially images a medical device 4.

[0101] Imaging system 2 is exemplarily shown as a C-arm X-ray machine. However, the following description can be similarly applied to other imaging systems 2 that are capable of producing images, particularly of the medical device 4 shown in object 10.

[0102] Object 10 may be, for example, a patient or a part of a patient's body. The patient may be placed on the patient bed 11 of the imaging system 2. Medical device 4 may be located in or partially located in object 10.

[0103] Also shown is a monitoring system 3 of the user assistance system 1, which is connected to the imaging system 2, enabling the monitoring system 3 to obtain information about the operational status of the imaging system 2. Furthermore, a display unit 6 is shown, which can display a graphical view of the image data from the imaging system 2. An exemplary example is shown of a medical device 4 in the object 10, particularly in the patient's organ 12 or a hollow organ. The display unit 6 may, for example, be part of the user assistance system 1, particularly the monitoring system 3.

[0104] The monitoring system 3 is configured to monitor for the movement of the medical device 4. Furthermore, the monitoring system 3 is configured to initiate a first risk mitigation measure 101 when image assistance via the imaging system 2 is disabled and movement of the medical device 4 is simultaneously detected by the monitoring system 3.

[0105] exist Figure 2 The diagram illustrates a block diagram of another exemplary embodiment of a user assistance system 1 for image-assisted navigation of a medical device 4 according to the present invention. The user assistance system 1 includes an imaging system 2 configured to generate and display a graphical view of image data for image-assisted navigation of the medical device 4, the graphical view at least partially imaging the medical device 4. The user assistance system 1 also includes a monitoring system 3 configured to monitor for the presence of movement of the medical device 4. The monitoring system 3 is configured to initiate a first risk mitigation measure 101 when image assistance via the imaging system 2 is deactivated and movement of the medical device 4 is simultaneously present according to the monitoring by the monitoring system 3.

[0106] Imaging system 2 can, for example, be configured to send status information to monitoring system 3 to determine its operating status. This operating status can, in particular, have at least two states, such as active and inactive. Monitoring system 3 can, for example, be designed as a data processing unit, and is therefore specifically configured to detect, store, and correlate data. In particular, information regarding the movement of medical device 4 can also be detected and processed by monitoring system 3.

[0107] The monitoring system 3 can trigger the first measure 101 when two conditions are met. The first condition is that the imaging system 2 is not activated, i.e., it is disabled. The second condition is that there is movement of the medical device 4. The first measure 101 can, for example, warn the user of the user assistance system 1, causing the user to, for example, stop the movement of the medical device 4 or activate the imaging system 2. As an escalation step, the first measure 101 can also include, for example, automatically stopping the movement. This can be achieved, for example, by disabling the actuator or, for example, by turning off the power supply. It is also possible that the monitoring system 3 activates the imaging system 2, i.e., enables a graphical view of the image data.

[0108] The first measure 101 is to reduce risk, specifically to reduce the risk of uncontrolled movement of the medical device 4. The medical device 4 may, for example, be located inside a person or animal. In this case, uncontrolled movement could lead to injury, for example, to the person or animal. Controlled movement, on the other hand, is movement of the medical device 4 that occurs when the imaging system is activated, i.e., with image assistance.

[0109] For example, in vascular surgery, medical device 4 may be located within object 10, particularly inside the patient's body, and image-aided navigation of medical device 4 is activated. Medical device 4 may include, for example, a catheter or guidewire located in the patient's organ 12. The imaging system 2 for image-aided navigation may be configured as an angiography system, for example. Here, a graphical view of continuously generated image data is provided to the user to assist the user in moving medical device 4. On the graphical view of the image data, the user may, for example, identify medical device 4 against a vascular background and move it accordingly.

[0110] For example, an anomaly may cause image assistance to be disabled, making it impossible or impossible for the user to recognize the progress of their movement. If the user continues to move while image assistance is disabled, a first measure 101 is triggered, for example, by emitting an auditory signal 150. Similarly, a visual signal 140 in the form of a warning message may be triggered, for example, on the display unit 6, to alert the user of the risk of uncontrolled movement in the form of text or symbols.

[0111] Similarly, due to movement, the medical device 4 may move out of the imaging area of ​​the graphic view of the image data and become no longer visible. In the presence of movement, a second measure 102 may be triggered, which may be in the form of emitting an auditory signal 150 and / or a visual signal 140. Likewise, when the medical device 4 moves and the image content of the graphic view of the image data does not meet preset standards, such as failing to meet quality standards such as signal-to-noise ratio or artifact-free performance, the second measure 102 may be triggered.

[0112] If the user's gaze is in a position that the gaze detection system 5 cannot detect, and the medical device 4 is still moving, then the third measure 103 can be initiated through the monitoring system 3. Furthermore, if the gaze detection system 5 can detect the user's gaze, but the gaze is not directed towards the display unit 6, and there is also movement of the medical device 4, then the fourth measure 104 can be initiated through the monitoring system 3.

[0113] To monitor movement, the monitoring system 3 can, for example, receive and analyze sensor signals 120 from at least one sensor 9. This at least one sensor 9 may be located adjacent to or within the medical device 4 and move with it, so that the sensor signal 120 corresponds to actual movement. Similarly, a portion of the medical device 4 may be located outside the object 10, for example, and movement can be detected by the monitoring system 3 using motion sensors.

[0114] In the described scenario, the movement of medical device 4 can be performed manually by the user or automatically controlled by the robotic system. Particularly in the case of the robotic system, one of measures 101, 102, 103, or 104 can also be to deactivate at least one actuator 7, thereby forcibly stopping, i.e., forcibly terminating the movement of medical device 4. This can be implemented, in particular, as an escalation measure to reduce the risk of injury.

[0115] In the robotic system, the monitoring system 3 can monitor the movement of the medical device 4, for example, via control signal 110. Control signal 110 can be generated by control device 8 to control the at least one actuator 7. When the medical device 4 can only move via the at least one actuator 7, the movement can be entirely instructed by control signal 110.

[0116] exist Figure 3 The diagram shows a block diagram of another embodiment of the user assistance system 1. The user assistance system 1 is, for example, based on... Figure 1 User assistance system 1 and / or Figure 2 User assistance system 1.

[0117] User assistance system 1 includes, for example, a gaze detection system 5 connected to monitoring system 3 and configured to transmit information about the user's gaze direction to monitoring system 3.

[0118] Specifically, when the corresponding first condition and the corresponding second condition are met simultaneously, the monitoring system 3 can activate the second measure 102, the third measure 103, and / or the fourth measure 104 based on other conditions. The corresponding second condition can be the same in each measure and corresponds to the movement of the medical device 4.

[0119] The first condition for the second measure 102 may be that the image quality is lower than the quality previously determined by setting a preset standard. The first condition for the third measure 103 may be that the gaze direction is detected by the gaze detection system 5. If the gaze detection system 5 does not detect the user's gaze direction, and simultaneously detects movement of the medical device 4, then the third measure 103 is activated. The first condition for the fourth measure 104 may be that the user's gaze direction is compared with the position of the display unit 6. If the comparison indicates that the user's gaze direction is not pointing towards the display unit 6, and simultaneously detects movement of the medical device 4, then the fourth measure 104 can be activated.

[0120] The activation of the first, second, third, or fourth measures 101, 102, 103, and 104 can be independent of the activation of other measures 101, 102, 103, and 104, and each measure 101, 102, 103, and 104 can be activated individually or in any combination with other measures 101, 102, 103, and 104.

[0121] The first, second, third, and fourth measures may each include outputting at least one warning signal 130, which should alert the user to the risk of uncontrolled movement of the medical device 4. This could be, for example, a visual signal 140, which can be output via an output device, such as display unit 6. The visual signal 140 may, in particular, be displayed on display unit 6 at a location determined by the gaze detection system 5. The at least one warning signal 130 may also include an auditory signal 150.

[0122] An advantageous implementation may correspond to the various measures 101, 102, 103, 104 being different from each other, allowing the user to easily and quickly deduce the cause of the corresponding measures 101, 102, 103, 104. In particular, the order of the different manifestations of auditory signal 150 and visual signal 140 can be determined.

[0123] The user assistance system 1 includes, for example, at least one sensor 9 connected to the medical device 4. This at least one sensor 9 may also be mechanically connected to the medical device 4, and thereby detect movement, for example. This at least one sensor 9 is connected to a monitoring system 3 and, for example, can transmit a sensor signal 120 to the monitoring system 3 indicating whether movement of the medical device 4 exists, thereby enabling the initiation of corresponding measures 101, 102, 103, 104 based on the sensor signal 120 from the at least one sensor 9.

[0124] In another embodiment of the invention, the user assistance system 1 includes at least one actuator 7, which can be controlled by a control device 8. The medical device 4 is particularly capable of movement via the at least one actuator 7. This embodiment may be referred to as automated movement or robotics. Movement of the medical device 4 can be achieved, or is configured to be achieved solely by, the at least one actuator 7. The control device 8 controls the at least one actuator 7 via a control signal 110. The control device 8 and / or the actuator 7 may also provide the control signal 110 to a monitoring system 3, enabling the monitoring system 3 to infer an impending movement of the medical device 4 from the presence of the control signal 110.

[0125] The first, second, third, and fourth measures 101, 102, 103, and 104 may include blocking control signal 110, thereby preventing medical device 4 from moving, for example, during the activation of the corresponding measures 101, 102, 103, and 104. This may also, in particular, represent an escalation of at least one previously output warning signal 130.

[0126] In this patent application, nouns and pronouns referring to people generally do not specify a particular gender.

Claims

1. A user assistance system (1) for image-assisted navigation in a medical device (4), wherein, - The user assistance system (1) includes an imaging system (2) configured to generate image data that at least partially images the medical device (4) and display a graphical view of the image data for image assistance in navigation of the medical device (4); - The user assistance system (1) includes a monitoring system (3) configured to monitor for the movement of medical equipment (4); - The monitoring system (3) is configured to initiate a first risk reduction measure (101) when image assistance via the imaging system (2) is deactivated and movement of the medical device (4) is present simultaneously with monitoring via the monitoring system (3).

2. The user assistance system (1) according to claim 1, wherein, The imaging system (2) is configured as a medical imaging system (2) for imaging the medical device (4) in organs (12) and / or tissues.

3. The user assistance system (1) according to any one of the preceding claims, wherein, The monitoring system (3) is configured as follows: - Check whether the image content of the image data and / or the image content of the graphical view of the image data conform to a preset standard; as well as - When the image content does not meet the preset standard and the medical device (4) moves simultaneously according to the monitoring by the monitoring system (3), a second risk reduction measure (102) is initiated.

4. The user assistance system (1) according to any one of the preceding claims, wherein, The user assistance system (1) includes a gaze detection system (5) configured to detect the user's gaze direction, and the monitoring system (3) configured to initiate a third risk reduction measure (103) and / or a fourth risk reduction measure (104) based on the result of the gaze direction detection.

5. The user assistance system (1) according to claim 4, wherein, The monitoring system (3) is configured to initiate a third risk reduction measure (103) when the gaze detection system (5) fails to detect the user's gaze direction and the medical device (4) is moving simultaneously as monitored by the monitoring system (3).

6. The user assistance system (1) according to claim 4 or 5, wherein - The user assistance system (1) includes a display unit (6) configured to display a graphical view of the image data; and - The monitoring system (3) is configured to activate the fourth risk reduction measure (104) when the gaze detection system (5) determines that the user's gaze direction is not pointing to the display unit (6) and the movement of the medical device (4) is present simultaneously as monitored by the monitoring system (3).

7. The user assistance system (1) according to any one of the preceding claims, wherein, The user assistance system (1) includes at least one actuator (7) configured as a mobile medical device (4).

8. The user assistance system (1) according to claim 7, wherein, - The user assistance system (1) includes a control device (8) configured to generate at least one control signal (110) for controlling the at least one actuator (7), and to provide the control signal (110) to the at least one actuator (7) and a monitoring system (3); and - The monitoring system (3) is configured to monitor whether the medical device (4) moves according to the control signal (110).

9. The user assistance system (1) according to claim 7 or 8, wherein, The first measure (101) includes deactivating the at least one actuator (7).

10. The user assistance system (1) according to any one of the preceding claims, wherein, - The user assistance system (1) includes at least one sensor (9) configured to output a sensor signal (120) in response to movement of the medical device (4); and - The monitoring system (3) is configured to monitor the movement of medical device (4) based on the sensor signal (120).

11. The user assistance system (1) according to any one of the preceding claims, wherein, The first measure (101) includes outputting at least one warning signal (130).

12. The user assistance system (1) according to claim 11, wherein, The at least one warning signal (130) includes a visual signal (140), and the user assistance system (1) is configured to display the visual signal (140).

13. The user assistance system (1) according to claims 6 and 12, wherein, The display unit (6) is configured to display the visual signal (140) at a display position located in the direction of the user's detected gaze.

14. The user assistance system (1) according to any one of claims 11 to 13, wherein, The at least one warning signal (130) includes an auditory signal (150), and the user assistance system (1) is configured to output the auditory signal (150).

15. A method for image assistance in navigation of a medical device (4) by displaying a graphical view of image data generated by an imaging system (2), wherein, The graphical view at least partially images the medical device (4). Among them, the monitoring system (3) is used. - Monitor for movement of the medical device (4); and - When image assistance is deactivated and the movement of medical device (4) is present simultaneously according to the monitoring of the monitoring system (3), the first risk reduction measure (101) is initiated.

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