Medical intervention device, method of determining and outputting positioning cues and computer program

Abstract

The present invention relates to a medical interventional device (1) comprising: - a flexible medical device capable of being introduced into the interventional area of ​​an object to be examined and having a proximal portion for operation; - an orientation element at the device having a marked projection surface; - a presentation device; - a processing device comprising: - an analysis unit designed to determine a predictive continuation trajectory from image data of the interventional area and positioning data describing the current position and orientation of the device, using characteristic data describing the flexibility of the device; - an output unit for outputting an image data-based illustration of the interventional area and the continuation trajectory on the presentation device; and - a light guide for projecting a light pattern onto the projection surface such that positioning cues for positional correction on the proximal portion of the device are formed, so as to achieve at least one continuation trajectory during further insertion of the device.

Description

Technical Field

[0001] This invention relates to a medical interventional device having an elongated medical instrument capable of being partially introduced into the interventional area of ​​a subject for examination. The medical instrument has a proximal portion, which needs to be positioned outside the subject for manual operation and is at least partially flexible. Furthermore, this invention relates to a computer-implemented method and computer program for determining and outputting positioning prompts. Background Technology

[0002] In the prior art, elongated medical devices are known, which are inserted into a patient for examination and / or treatment. Here, needles, such as biopsy needles, excision needles, and similar needles, are specifically referred to as medical devices. It is generally stipulated that the needle is moved within the object of examination such that the tip of the needle reaches the target area of ​​the object, particularly the target object itself. The target area may, for example, be a tumor or other tissue of interest and / or tissue to be treated. To reliably reach the target area, especially with the assistance of the user of a manually guided device, numerous effects need to be considered.

[0003] Therefore, it is important to consider, for example, that when instruments, especially needles, are inserted into soft tissue, the soft tissue is generally not statically fixed. On the one hand, there is movement within the object being examined, such as the patient's macroscopic movements and / or circulatory movements, such as respiratory movements and heartbeats. On the other hand, the instrument itself may also cause tissue movement. Thus, organs and / or other anatomical structures may be pressed laterally and / or posteriorly and / or undergo other deformations. Therefore, users, such as interventional radiologists, typically do not use navigation when guiding the needle, but instead guide the needle (or other instrument) step by step forward, interrupted by repeated imaging, especially X-ray imaging, and path correction. It is known, for example, that to correct the instrument path, the proximal portion of the partially inserted instrument, i.e., the portion pointing towards the user, is moved laterally so that the instrument can be advanced a further distance afterward. If the instrument path deviates significantly from the desired path, the instrument can be pulled back a distance and recalibrated. This correction of the instrument path is based on the user’s intuition and experience, in which each correction affects the tissue of the object being examined, prolongs the duration of the intervention, and increases the radiation load due to repeated image recordings by X-ray imaging.

[0004] Depending on the instrument's diameter, material, and flexibility—its mechanical properties—lateral movement of the proximal portion of the instrument alters the rigid orientation of the partially inserted instrument within the anatomical structure, or allows for elastic bending, thereby creating a curved needle path. There are also wider transition zones where both orientation changes and bending occur. All these estimations have so far relied on the user's experience and intuition.

[0005] The most commonly used method today for interventions using medical devices, especially needles, is the so-called "Step-and-Shoot method," as previously described. Here, the needle is advanced step-by-step, and position checks are performed regularly using X-ray imaging. Whenever the needle cannot reach the target area in its current direction, it is reoriented accordingly. Then, it is advanced a little further and a new scan is performed. However, this requires considerable user experience.

[0006] In existing techniques, it is also suggested to perform pre-planning, in which static and linear needle trajectories are planned, for example, in a three-dimensional pre-image dataset of the object being examined. The planned needle trajectory can be visualized to enable intervention via visual navigation, where, for example, intersecting laser lines can indicate the needle trajectory. However, this approach does not take into account either adapting to potentially altered anatomical structures or the flexibility of the instruments, especially the needles.

[0007] Finally, it has been suggested in the prior art that instruments, particularly needles, be introduced using robots. For example, it is suggested that the robot progressively advances the needle and performs an examination scan via computed tomography. Here, the current position and shape of the target region within the anatomical structure, and, if necessary, the current orientation, are determined from the image data, thereby automatically calculating a suitable needle path and corrected curvature for the portion outside the patient. The robot is then manipulated according to the suitable needle path. After performing these steps multiple times, the needle automatically reaches the target region by means of a curvature adapted to the changes in the anatomical structure. For example, WO 2022 / 254436 A1 discloses a system, apparatus, and method for real-time updating the trajectory for introducing a medical device into a target within an object, wherein control is achieved according to a closed-loop control system toward the moving target.

[0008] For the use of rigid screws, it has been recommended to generate a diagram (Darstellung) to assist the user. This diagram displays, through the overlay of image data, which shows which direction the screw will move if it is pushed further straight forward into the object being inspected. Summary of the Invention

[0009] The technical problem to be solved by the present invention is to provide intuitive support for users when manually advancing medical devices into the object of examination, and the support is particularly capable of reaching the target area quickly and reliably.

[0010] This technical problem is solved according to the present invention by means of a medical interventional device, a computer-implemented method, and a computer program. Advantageous extensions are derived from the specification.

[0011] The present invention will now be described in detail with respect to medical interventional devices, methods, and computer programs. The descriptions of the corresponding inventive solutions are applicable to each other, and therefore, in particular, the design and description of medical interventional devices can be applied to computer-implemented methods and vice versa.

[0012] The medical interventional device according to the present invention has:

[0013] - An elongated medical device capable of being partially introduced into the interventional area of ​​a subject for examination, the medical device having a proximal portion that needs to be disposed outside the subject for manual operation of the medical device and is at least partially, and particularly elastically, bendable.

[0014] - An orientation element disposed on and / or integrated in the instrument, the orientation element having a projection surface marked with at least one mark indicating at least one point.

[0015] - Presentation device

[0016] - A processing apparatus, the processing apparatus comprising:

[0017] - An analysis unit designed to determine at least one predictive, particularly nonlinear, continuous trajectory from image data of an examination object presenting the intervention area and positioning data describing the current position and orientation of the medical device, using characteristic data describing the flexibility of the medical device.

[0018] - An output unit, the output unit being configured to output an image-based illustration of the intervention area and at least one continuing trajectory on a presentation device; and

[0019] - A light guide device for projecting at least one light pattern onto a projection surface such that, by observing at least one of the at least one mark and the light pattern as a whole, a positioning cue is formed for manual positional correction on the proximal portion of the medical device, so as to achieve the selected continuation trajectory among the at least one continuation trajectory during further insertion of the medical device.

[0020] The examination subjects may be, for example, human and / or animal patients and / or examination phantoms. Therefore, it can also be understood that the medical interventional device according to the invention, as part of a medical interventional system, has multiple components that, through the combined action of these components, allow for the output of intuitive, assisted positioning prompts.

[0021] Medical devices, especially surgical instruments, and preferably needles, particularly puncture needles. Other medical devices that may be considered include drills, screws, diagnostic instruments such as endoscopes and / or catheters, and / or saws (Trokare). Medical devices are elongated, and therefore extended, and preferably needle-shaped and / or rod-shaped. In the operating state of the device, the medical device is preferably at least partially disposed inside the object being examined, specifically in the interventional area. The portion of the medical device disposed inside the object being examined is also referred to herein as the distal portion.

[0022] Orientation elements can be arranged on a medical device, particularly the proximal segment of the medical device, in a defined orientation relationship, especially a defined spatial relative position and / or relative orientation and / or relative posture. The orientation elements and / or the medical device may have fixing elements, such as clamping devices and / or insertion devices and / or magnetic retainers. Alternatively or additionally, the orientation elements may be at least partially integrated into the medical device, particularly on the proximal portion, for example, on the surface of the medical device.

[0023] The orientation element has a projection surface on which at least one mark is provided. In addition to the mark, the projection surface may be painted with a specific color, such as white. The projection surface is formed, in particular, by at least a portion of the visible surface of the orientation element. The at least one mark indicates at least one point and may be at least dot-shaped. The at least one mark may be designed as a geometric object, such as a line and / or a circle and / or a cross. Furthermore, the at least one mark may be designed as a contrasting object, such as an imprint and / or a protrusion and / or a blank space on the substrate of the orientation element, particularly on the surface of the orientation element.

[0024] The processing device may have an interface for receiving image data (and, if necessary, positioning data). The analysis unit is preferably designed to determine positioning data by analyzing the image data, which in particular also shows the medical device within the intervention area. However, positioning data can also be provided, at least in part, in other ways, such as by a positioning system that otherwise determines the position and / or orientation of the medical device and registers it with the image data.

[0025] The processing device can be designed to receive medical image data via an interface. Receiving image data may in particular include acquiring and / or reading from computer-readable data storage and / or receiving it from a data storage unit, such as a database. However, the image data is preferably provided by a medical imaging device, which may also be part of an interventional device.

[0026] Advantageously, the image data includes a two-dimensional or three-dimensional spatially resolved mapping of the object being examined. The image data can also be temporally resolved to map the object being examined. The image data can include multiple image points, particularly pixels or voxels, having image values, such as intensity values ​​and / or attenuation values, which map, in particular, to, the object being examined. The image data preferably includes X-ray image data of the object being examined, particularly computed tomography (CT) image datasets and / or projection images, such as fluoroscopic images. Appropriately, the image data can also at least partially map a medical device.

[0027] Presentation devices may include screens and / or displays and / or projectors and / or data glasses, which are designed to display graphic illustrations.

[0028] The light guide device may advantageously include a light source, particularly a laser light source, designed to emit a light pattern. For this purpose, the light guide device may, for example, include an aperture. As will be described in detail below, the processing device may have a control unit for manipulating the light guide device. The light guide device may particularly be designed to emit at least one laser fan and / or at least one laser beam for projecting lines or points. The light guide device may have at least one actuator to achieve changes in the light pattern. The manipulation implemented by the control unit may involve the actuator.

[0029] If the patient is supported on an adjustable patient bed, the relative position and orientation of the light pattern can also be controlled by the actuators of the patient bed. For example, a design is known in which two laser fans, and thus the lines in the light pattern, indicate the orientation of the (typically axial) slices recorded by the computed tomography (CT) scan and the imaging device, here at the center of the CT scan device. The centerline can then be positioned as needed by laterally adjusting the patient bed.

[0030] The processing device can be used as a control device for the interventional device as a whole. The processing device may have at least one storage device and at least one processor. Functional units, such as analysis units and output units, may be constructed in hardware and / or software. Of course, in addition to the functional units described above, other functional units may also be considered in principle.

[0031] The analysis unit is designed to determine the continuing trajectory resulting from specific positional corrections and further advancement on the proximal portion. The illustration allows the user to evaluate at least one continuing trajectory, while positioning cues guide the user to perform these positional corrections for the (selected) trajectory. The current state of the anatomical structure of the object being examined within the intervention area is included here, taking into account the (current) image data. However, according to the invention, the medical device is not assumed to be rigid, but rather these mechanical properties allowing flexibility are assigned to actual, especially elastic, bendable (biegsam) devices when determining at least one continuing trajectory, thereby forming reliable and accurate predictions and simultaneously assisting the user in the bendability of the device, in relation to characteristics or degrees of freedom that have previously been considered only intuitively by the user, when manually guiding the medical device, especially needles. Thus, a three-dimensional evaluation can be performed, particularly during determination. Here, the bendability of the device is not limited to the proximal portion, but also includes the distal portion introduced into or capable of being introduced into the patient's body, thus a curved shape may / should occur within the patient's body.

[0032] Specifically, the analysis unit is designed to determine at least one continuing trajectory by simulating and / or modeling the effect of medical device position corrections performed in the proximal portion, particularly including curvature, on the behavior of the device in the distal portion of the examined object, especially during advancement. If, as will be further elaborated below with respect to the first embodiment, markers should be assigned to specific continuing trajectories, then curvature in the proximal portion can be preset to use position corrections described by the corresponding markers. Alternatively or supplementarily, it may be considered to provide the analysis unit with target information about the device target within the intervention area, particularly the target region, and the analysis unit is designed to determine at least one continuing trajectory for approaching the device target as closely as possible and the position corrections required for this (particularly including curvature in the proximal portion). In the second embodiment, which will also be described in detail below, projection points can represent this. For example, in the first embodiment described above, the analysis unit can determine the nearest marker describing the position correction. Curvature in the proximal portion will also result in curvature in the distal portion.

[0033] In the illustration on the display device, the continuation trajectory, which can be understood as a virtual continuation, can be accurately superimposed as image data position. Here, the continuation trajectory can be displayed as graphic elements, especially lines and / or arrows. Here, the continuation trajectory can extend at least partially non-linearly, for example, in a curved manner.

[0034] This approach significantly simplifies device path calibration, especially for inexperienced users, and allows interventions to be performed more quickly and with less radiation. It also provides an improved "Step-and-Shoot" approach, with significant added value provided by considerations of the flexibility of medical devices and the provision of positioning cues as workflow indicators.

[0035] It should be noted here that the method described herein can be performed, in particular, without prior planning. This method was not possible in previous interventions using elongated medical instruments, especially needles, guided by light patterns. Within the scope of this invention, the user can initially introduce the medical instrument into the object of examination without guidance, or if necessary, with real-time imaging, and then record image data. If needed or necessary, the instrument trajectory can be adjusted accordingly using positioning cues to reach the desired target area, i.e., the instrument target. This can, of course, be performed multiple times during the intervention. Alternatively, instrument navigation methods known in the art, such as laser needle guidance, can also be used.

[0036] As mentioned above, within the scope of this invention, two alternative implementation methods can be considered for how to output location prompts to users in an intuitive and targeted manner through light patterns and at least one mark.

[0037] In a preferred first embodiment, it can be specified that a light pattern marks projection points. To select a chosen continuation trajectory, the projection points need to be aligned with the markers assigned to the chosen continuation trajectory. The output unit is designed to generate a diagram with marker information assigned to at least one continuation trajectory and describing the assigned markers. Specifically, it can be specified that, to align the projection points with the markers, a target point defined by the markers is overlapped with the projection points. In the case of multiple continuation trajectories and multiple markers, the markers and marker information can be optically distinguishable. In other words, it can be specified that the markers have optically distinguishable characteristics. To output the marker information, the continuation trajectories can also be represented (or presented) using optically distinguishable characteristics, wherein, in particular, the optically distinguishable characteristics of the continuation trajectories or, more generally, the marker information, can be paired with the optically distinguishable characteristics of one of the markers. For example, multiple markers can have color coding and / or black-and-white coding and / or surface properties, especially reflectivity and / or contour, as optically distinguishable characteristics, and multiple markers can be uniquely identified by these optically distinguishable characteristics. In one specific implementation, if the marker has color coding, a corresponding color can also be selected for the continuing trajectory shown in the illustration.

[0038] In particular, since multiple markers and their lag on the orientation element are known to the processing device, the analysis unit can be designed to determine appropriate continuation trajectories for the markers and the resulting position corrections as described above, including the bending of the medical device at the proximal portion.

[0039] As will be explained, before positional correction is performed, the projection point can be projected, for example, along the longitudinal direction of at least the proximal portion of the instrument, particularly along the axis of the instrument's lever. This adjustment can be achieved by manipulating the light guide, particularly based on positioning data or planning information, via the control unit of the processing device. In other words, the processing device can have a control unit designed to manipulate the light guide to output a light pattern such that the projection point is projected along the current longitudinal direction of at least the proximal portion of the medical device, particularly along the axis of the instrument's lever. Alternatively or additionally, the control unit can be designed to manipulate a patient's bed with the subject of examination positioned such that the relative position and orientation of the medical device and the light pattern cause the projection point to be projected along the current longitudinal direction of at least the proximal portion of the medical device, particularly along the axis of the instrument's lever. Here, the center point of the directional element can appropriately correspond to the projection point, which indicates the current longitudinal direction.

[0040] In this first embodiment, the orientation element can be understood as a "target disk" in which, in order to perform position correction, particularly at a preset point of action on the proximal portion of the medical device, the projection point is aligned with a marker corresponding to the selected continuation trajectory. Which marker this is is conveyed by the marker information shown in the illustration.

[0041] In a suitable extended design of the invention, the light pattern may include at least one azimuth line displaying the orientation of the image, particularly the image plane of the layer in which the image data is used in the image. For this purpose, the light guide may be operable via a control unit and / or registered with a medical imaging device providing the image data. Particularly in computed tomography (CT) devices that typically reconstruct axial layers into layer images, the layer orientation may be fixedly preset; therefore, in order to project the azimuth line in a fixedly adjusted manner, the light guide may be designed such that the azimuth line displays the layer orientation. This azimuth line can be displayed, in particular, via a laser fan. Therefore, when using a CT scanner, the provided light guide, which displays the layer orientation on the patient, can also be suitably used within the scope of the invention.

[0042] It should be noted that in light guide devices with correspondingly controllable adjustable light fans and / or laser fans for the azimuth line, the azimuth line can also be adjusted when adjusting the presentation orientation. This is particularly suitable when the light guide device is not intended to operate within the same axial layer as is usually specified, but rather the layer can be changed. In this case, or even if, as described above, the light guide device is not originally fixed to a (fixed) layer orientation, the control unit of the processing device can be designed to control the light guide device to project the azimuth line according to the current presentation orientation.

[0043] Relatedly, the light pattern can be specified to include additional projection lines, particularly those perpendicular to the azimuth line. For example, such additional projection lines can display the center of the imaging device, especially in the case of a computed tomography (CT) scanner. However, the additional projection lines can also be appropriately adjusted by corresponding actuators to, for example, display the current longitudinal direction of at least the proximal portion of the medical device. Furthermore, it is conceivable to adjust the relative position and orientation of the additional projection lines by manipulating an adjustable patient bed.

[0044] However, in a particularly advantageous extension of the first embodiment, it can be specified that, in order to mark the projection points on the azimuth line, the light pattern includes azimuth points, which can be controllably adjusted based on positioning information by a processing device. For example, such azimuth points can be preset in a simple manner using the laser beam of a corresponding laser source of the light guide device, the azimuth points indicating the position along the azimuth line. It is particularly suitable here that the azimuth line and the azimuth points are different colors. For example, a green azimuth point can be used for a red azimuth line. Here, the azimuth point can be understood as an extended, especially at least substantially circular, shape, where, for simplicity, a small projection element is preferred. For example, the azimuth point can also be a short azimuth line that can move along the azimuth line. The position of the azimuth point along the azimuth line can be adjusted by means of the control unit of the processing device. Setting such azimuth points is a particularly suitable and easily implemented method, especially when the lateral fixation of the patient's bed is insufficient in the case of an additional projection line that can be adjusted to display the center of the imaging device.

[0045] In a particularly suitable extended design, it can be specified that the marker has at least one orientation line that needs to coincide with the azimuth line, especially such coincidence (or alignment) as to keep the medical device within the image plane or layer shown in the illustration when the projection point remains on the coincident orientation line. This is particularly suitable when the axial layers of the reconstructed computed tomography image are used as image data as described above. The orientation element can be rotatably arranged on the medical device so that the orientation line and the azimuth line can coincide; however, it is also conceivable to rotate the medical device about its longitudinal axis.

[0046] Orientation lines and azimuth lines together provide the user with intuitive orientation, which not only makes the illustration easier to understand but also correctly assigns markings to the presented continuum. This may also be appropriate in situations where work is not performed within the presented layer as usual, but rather should be moved away from that layer. However, it is generally advisable to work within a specific layer to also simplify further imaging, such as when re-recording image data.

[0047] Here, the orientation element can also be designed for operation within a specific layer. For example, it can be specified that markers that can be assigned to a continuing trajectory are placed along the orientation line, so that when the orientation line coincides with the azimuth line, the medical device remains within the layer marked by the azimuth line for each position correction. Here, the orientation element can be appropriately designed elongated along the direction of the orientation line. This design has proven particularly useful when combined with the use of projection points, as this creates a predominant extension of the light pattern in the direction of the azimuth line. Thus, to perform position correction within a layer corresponding to the image plane also illustrated, it is only necessary to align the orientation line with the azimuth line of the light pattern and align the projection point with the corresponding marker along the orientation line, which corresponds to the selected continuing trajectory in the illustration according to the marker information.

[0048] Specific embodiments within the scope of the first implementation method may also be specified,

[0049] - The markings form at least a portion of a crosshair comprising at least one directional line, the center of which coincides with the projection point before position correction is performed, and the loops of the crosshair are assigned, in particular, different colors to the corresponding continuation trajectories, and / or

[0050] - The markers form a coordinate grid, especially a matrix, in which at least the markers that can be assigned to the continuation trajectory are assigned coordinates.

[0051] The advantage of crosshairs is that they allow for quick and convenient alignment of the azimuth line with one of two (mutually perpendicular) orientation lines, especially when the work would otherwise be sustained within a specific layer. For example, markers can thus form colored circles of crosshairs, where the projection point can be moved in the desired direction along the selected orientation line coinciding with the azimuth line towards the desired marker of the desired color given by the marker information, in order to perform position correction. It should also be generally noted that when working within a layer that also forms the image plane illustrated, it is appropriate to separately determine two continuation trajectories of a color, particularly the color of the crosshair circle, i.e., one trajectory for each correction direction within the layer. Through the intuitive positioning using the azimuth lines, the user can easily and correctly assign the appropriate direction for correction within the layer.

[0052] When using markers in a matrix-like coordinate grid, such as marker points or marker circles in a regular matrix arrangement, coordinate descriptions can be used as marker information, for example, so that for a continuation trajectory of B3, the projection point should move accordingly in B3 to the marker in the coordinate grid. However, even if the projection points cannot be arranged in the center, i.e., they do not always show the same direction, such as at least the longitudinal direction of the proximal portion of a medical device, the coordinate grid is still very useful because it allows for relative allocation, for example, in a "one to the right, three down" manner.

[0053] In an alternative second embodiment, a different method is chosen, in which the light pattern, particularly the projection point marking (which may be a single mark), should move in which direction? This means that, in this embodiment, the orientation element has only one mark defining the orientation point, and the processing device is designed to manipulate the light guide to mark the projection point assigned to the continuation trajectory on the projection surface. To select the assigned continuation trajectory, the projection point needs to be aligned with the orientation point, i.e., coincident. This design is particularly suitable when a continuation trajectory leading optimally to the target area or instrument target in the intervention area has been determined and should be followed as precisely as possible. The projection point can then indicate in which direction the orientation point defined by at least one mark should move to perform position correction, thereby achieving the selected continuation trajectory. However, in principle, it is also possible to consider multiple distinguishable projection points assigned to different continuation trajectories as part of the light pattern. In other words, the projection points can have distinguishable optical characteristics, which are described by marking information or whose marking information corresponds to the distinguishable optical characteristics of the projection points. Therefore, the continuation trajectory can be selected by moving the orientation point to the corresponding projection point as shown in the figure.

[0054] In the second embodiment, it is preferable to incorporate the control unit as part of the processing device in order to properly control the light guide device and / or the patient bed so that at least one projection point correctly displays the corresponding continuation trajectory.

[0055] Specifically, it can be stipulated that the actuators assigned to the laser source, such as those for adjusting the laser beam projected into the room or the cross-laser plane, are manipulated such that the movement of the proximal end of the medical device is displayed through a projection point. This movement must be achieved as a positional correction to achieve a specific continuous trajectory, which is selected, for example, through user input and / or automatically. In other words, the light pattern is moved and the desired degree of curvature of the medical device is displayed as a new projection point.

[0056] Therefore, in the second embodiment, only a simple orientation element is needed, and the continuation trajectory can be adjusted with high precision, intuitively and easily, especially to guide the continuation trajectory to the instrument target.

[0057] It should also be noted that for both implementations, a targeted selection of one of multiple continuing trajectories via user input can be considered. For example, in the second implementation, the user can select a continuing trajectory from multiple suggestions, and then the projection point displays the necessary positional corrections for this continuing trajectory. Thus, it can be specified, particularly in the first implementation, that marking information, such as in terms of a coordinate grid, is gradually displayed in the illustration only when a selection is made, and then an output for relative movement within the coordinate grid can be implemented for said coordinate grid.

[0058] In a suitable extended design of the invention, the proximal portion may be provided with a point of action for manually performing position correction, wherein the analysis unit is designed to consider the orientation of the point of action when determining the at least one continuation trajectory. Here, the point of action is preferably located at the proximal end of the device and / or adjacent to and / or on the orientation element; however, other points of action can also be considered. Depending on the location of the point of action, and therefore depending on the position in which the user holds the medical device to perform position correction, other shapes, particularly concerning curvature, may appear on the proximal portion. According to the invention, these shapes can be optimally considered and included in the determination of the continuation trajectory when the point of action is known. The further out the point of action, the more the curvature characteristics of the device can be utilized. In embodiments where different points of action are provided or can be used, the currently used point of action can be derived, for example, from user input.

[0059] In a preferred design, the interventional device may have an imaging unit for recording at least a portion of the image data. Such interventional workstations, which already possess imaging units, are proposed in principle in the prior art, particularly for monitoring interventions. In this case, the processing unit may also have a recording unit for manipulating the imaging unit to record image data. The use of a computed tomography (CT) scanner is particularly preferred, as this is known in principle, especially for guided interventions using long medical instruments, particularly needles, and allows for the implementation of procedures, particularly during planning. CT scanners provide three-dimensional image data, particularly for axial slices encompassing the interventional area, in a simple and rapid manner; these three-dimensional image data also clearly show the instruments and are therefore easily analyzed. In addition to CT scanners, other imaging devices, particularly X-ray devices, may be alternatively or supplementarily considered. For example, the imaging device may also be a C-arm X-ray device, having a C-arm on which an X-ray emitter and an X-ray detector are arranged opposite each other. Different projection / recording geometries can be set (or adjusted) using the degrees of freedom of the C-arm's movement. Of course, other imaging methods may also be used in principle.

[0060] Regarding C-arm X-ray devices or other X-ray devices that allow for different recording geometries, it should also be noted that fluoroscopic monitoring is typically used. Here, to identify instrument paths in all spatial directions, the recording geometry, particularly the angle of the C-arm, can be varied. Typical examples of interventions performed under fluoroscopic observation include bone biopsies, spinal fusion, and vertebroplasty. To determine the image data from which conclusions should be drawn regarding the location of instruments and / or anatomical structures, it can be specified in this case that fluoroscopic images of the medical instruments are recorded from at least two projection directions to obtain the required three-dimensional information. However, C-arm CT acquisition can also be considered.

[0061] Generally, it may be suitable to have the light guide fixedly mounted on and / or integrated into the imaging device. This is already known for computed tomography devices used with long instruments, especially needles, to perform minimally invasive interventions, in order to achieve instrument guidance and / or provide the user with optimal orientation, for example, by displaying the axial slice orientation (especially via azimuth lines) and / or the center of the imaging device. Here, the light guide can be arranged, for example, on a gantry. In principle, this can also be achieved with a C-arm, for example, by returning to the so-called "bull's eye view" after recording image data at different angles, where the light guide or light pattern is aligned with the azimuth point along at least the longitudinal axis of the proximal portion of the instrument. For example, in this case, the light guide, especially a laser guide, can be arranged on the X-ray detector, as described in the publication "Improved Laser Needle Guidance" by Dr. Alois Regensburger et al. (Siemens AG, 2019).

[0062] As mentioned earlier, the analysis unit used to determine the positioning data can be formed at least partially from image data. This eliminates the need for additional positioning data and / or allows for verification of the reliability of the positioning data. Especially in the case of X-ray imaging, because medical devices are high-contrast objects, this detection of the device and determination of the positioning data can be easily achieved using commonly used algorithms.

[0063] Particularly suitable is the analysis unit designed to register image data with pre-image data of the object being examined. Especially in the case of fluoroscopic images, anatomical structures of interest in X-ray imaging are sometimes less clearly mapped, while they are easily identifiable or segmented in the pre-image data. Therefore, in general, in suitable extended designs, registration with such pre-image datasets, such as 3D computed tomography (CT) image datasets and / or magnetic resonance imaging (MRI) image datasets, can also be performed, where anatomical structures, such as different types of tissue, may have been segmented, or the segmented areas may be assigned mechanical properties. However, it is preferable to determine anatomical information describing the current state of the anatomical structures in the intervention area directly from the image data, so as to understand, for example, any movement and / or other motions that occur. This anatomical information can also be used, for example, to update the pre-image dataset regarding tissue boundaries. This can also be achieved through the registration itself when performing flexible registration with respect to the anatomical structures in the intervention area. If the image data also clearly shows the anatomical structures, flexible registration can ultimately directly lead to information about any changes that occur.

[0064] Image data displaying the current condition of a partially introduced medical device can generally be, in particular, data from control scans. Within the scope of the analysis, positioning data can be determined from the image data as previously described, wherein, by analyzing the image data (especially in conjunction with pre-registered image data that is rigidly or preferably elastically fitted thereto), preferably through conventional image analysis methods, particularly including segmentation and / or location determination and / or structural detection, the following analytical information can be obtained:

[0065] - Positioning information (instrument orientation, instrument shape (e.g., along the instrument's centerline and / or a functional approximation of the instrument's shape), and the location of the distal and proximal ends of the instrument (if visible).

[0066] - The entry point of the instrument into the object being examined, as well as the instrument portions located inside and outside the object being examined (if the proximal portion of the instrument located outside the object being examined is not or not fully included in the image data, the direction of extension to the proximal end can be assumed to be in a posture without force, i.e. without active deflection; for this purpose, the characteristic data may also appropriately include other information about the medical device, especially its length).

[0067] - Preferably, anatomical information, particularly including anatomical structures, such as organs and their boundaries, especially the current pose of the target region. Furthermore, the flexibility and / or mobility of the anatomical structures can be known or assumed.

[0068] Especially when registered with pre-planned image data for execution planning, the attitude of the original planned instrument trajectory (planned trajectory) can also be tracked in the image data.

[0069] Based on the available information, simulations and / or model calculations can be performed to determine how positional corrections, including device bending, at the rear (proximal) end of the device will affect the device's posture and shape within the patient's body, as well as the trajectory of the front (distal) end of the device (during further advancement). Characteristic data describing the flexibility of the medical device (particularly in the proximal and distal portions) are also considered here. These characteristic data include the device's mechanical and / or elastic parameters. As previously mentioned, mechanical properties may also be known or hypothesized for anatomical structures.

[0070] Accordingly, it can be appropriately specified that the analysis unit is designed to determine characteristic data from the provided device information. Here, device information may, for example, describe the model and / or type and / or category of the device. For example, characteristic data can be assigned to device information in a database and / or lookup table (LUT). However, in principle, it may also be considered to apply standard assumptions to the characteristic data.

[0071] Preferably, in addition to at least one continuing trajectory, the analysis unit is also designed to determine the future trajectory formed without position correction, and the output unit is designed to display the future trajectory graphically. In this way, the user also obtains information about how the instrument path will develop without performing position correction. The continuing trajectory can be compared intuitively and conveniently with the future trajectory, and the arrival at the target area can be evaluated.

[0072] Furthermore, the analysis unit is designed to determine a recommendation for the advancement path, while the output unit is designed to output that recommendation. For example, the pre-calculated reliability of the continuing trajectory can be determined, where advancement can be recommended up to a specific threshold of the pre-calculated reliability. After advancing the recommended advancement distance (e.g., in centimeters), new image data recording can be appropriately performed, thus performing a new control scan, and a new continuing trajectory can be determined for position correction.

[0073] In addition to interventional devices, the present invention also relates to a computer-implemented method for determining and outputting positioning prompts for an elongated medical device capable of being partially introduced into the interventional area of ​​an examination subject for intervention, the medical device having a proximal portion for manual operation that needs to be disposed outside the examination subject and is at least partially flexible, wherein directional elements disposed on and / or integrated in the device are used, the directional elements having a projection surface with at least one mark indicating at least one point, wherein the method comprises the following steps when the device has already been partially introduced into the examination subject:

[0074] - Image data of the object being examined is provided through the interface of the processing device. This image data presents the intervention area and determines positioning data describing the current position and orientation of the medical device.

[0075] - Using the analysis unit of the processing device, and with the help of characteristic data describing the flexibility of the medical device, at least one predictive, particularly nonlinear, continuous trajectory is determined from image data and positioning data.

[0076] - Using the output unit of the processing device, an image-based diagram of the intervention area and at least one continuing trajectory is output on the presentation device; and

[0077] -In particular, by means of the control unit of the processing device, the light guide device for projecting at least one light pattern onto the projection surface is operated in such a way that by observing at least one of the at least one mark and the light pattern as a whole, a positioning cue is formed for manual position correction on the proximal portion of the medical device, so as to achieve the selected continuation trajectory among the at least one continuation trajectory during further insertion of the medical device.

[0078] All descriptions relating to the interventional device according to the invention can be similarly applied to the method according to the invention, which can also be called a prompting method, and vice versa, thus obtaining the advantages already mentioned. In particular, the positioning data is preferably determined by the analysis unit when using image data. The method may also include a step of recording image data, which is controlled by the recording unit.

[0079] Positioning prompts here can be understood as workflow prompts, thus forming a support or decision-making aid tool for the user, which is provided after the medical device is positioned, especially within the scope of controlled scanning that provides image data. Therefore, it should be noted that even when applied within the scope of interventions performed on the patient, within the scope of the prompting method according to the present invention, no guiding, advancing, or other operations are performed on the medical device within the examination object.

[0080] As described above regarding the interventional device, two basic, alternative implementation methods can also be considered for this method. On one hand, the light pattern can mark projection points. To select a chosen continuation trajectory, the projection points need to be aligned with the marks assigned to the selected continuation trajectory. This involves generating a diagram with marking information, which is assigned to at least one continuation trajectory and describes the assigned marks. On the other hand, the directional element can have only one mark defining the directional point, and the processing device manipulates the light guide device to mark the projection points assigned to the continuation trajectory on the projection surface. This also involves aligning the projection points with the directional point to select the assigned continuation trajectory.

[0081] The prompting method according to the present invention can be integrated into a method for treating and / or examining a subject using an elongated medical device capable of being partially introduced into the intervention area of ​​the subject for intervention. The medical device has a proximal portion that needs to be disposed outside the subject for manual operation and is at least partially flexible, wherein, in order to determine and output positioning prompts after the device has been introduced into the subject,

[0082] - Using an orientation element disposed on and / or integrated in the instrument, the orientation element having a projection surface marked with at least one mark indicating at least one point,

[0083] - Image data of the object being examined is provided through the interface of the processing device. This image data presents the intervention area and determines positioning data describing the current position and orientation of the medical device.

[0084] - Using the analysis unit of the processing device, and with the help of characteristic data describing the flexibility of the medical device, at least one predictive, particularly nonlinear, continuous trajectory is determined from image data and positioning data.

[0085] - Using the output unit of the processing device, an image-based illustration of the intervention area and at least one continuing trajectory is output on the presentation device; and

[0086] - Specifically, by means of the control unit of the processing device, a light guide device for projecting at least one light pattern onto a projection surface is operated in such a way that, by observing at least one of the at least one mark and the light pattern as a whole, a positioning cue is formed for manual positional correction on the proximal portion of the medical device, so as to achieve the selected continuation trajectory among the at least one continuation trajectory during further insertion of the medical device.

[0087] Following this, the positioning is manually indicated by the person performing the intervention at the proximal end of the instrument, especially at the point of action, and the instrument is further pushed into the object being examined.

[0088] The method can preferably be performed iteratively, i.e., after the instrument advances a specific, especially a recommended, distance, new image data is recorded / provided, and further positioning cues are generated and output based on the cuing method.

[0089] The computer program according to the invention can be directly loaded into the storage device of the processing apparatus of the interventional device and has program means that, when the computer program is executed, the program means cause the processing apparatus to perform the steps of the prompting method according to the invention. The computer program can be stored on an electronically readable data carrier, which includes control information stored thereon, the control information including at least one computer program according to the invention and designed to, when the data carrier is used in the processing apparatus of the interventional device, design the processing apparatus to perform the prompting method according to the invention. Attached Figure Description

[0090] Other advantages and details of the invention will become apparent from the embodiments described below and from the accompanying drawings.

[0091] In the picture:

[0092] Figure 1 A flowchart illustrating a general embodiment of the method according to the present invention;

[0093] Figure 2 A schematic diagram of the main components of the interventional device according to the present invention is shown;

[0094] Figure 3 The functional structure of the processing device of the interventional equipment is shown;

[0095] Figure 4 A detailed schematic diagram of a medical device used in a first embodiment of the present invention is shown;

[0096] Figure 5 A light guide device for a first embodiment of the first implementation is shown;

[0097] Figure 6 An orientation element for the first embodiment is shown;

[0098] Figure 7 A view showing the prompts in the first state of the instrument and orientation elements;

[0099] Figure 8 This shows a view of the first state on the projection plane;

[0100] Figure 9 A view showing the prompts in the second state of the instrument and orientation element;

[0101] Figure 10 The second state is shown as a view on the projection plane;

[0102] Figure 11 A view showing the prompts in the third state of the instrument and orientation element;

[0103] Figure 12 The view of the third state on the projection plane is shown;

[0104] Figure 13 The illustrations shown are related to the first embodiment and are intended for output on a presentation device;

[0105] Figure 14 An orientation element for a second embodiment of the first implementation is shown;

[0106] Figure 15 A view showing the prompts in the first state of the instrument and orientation elements;

[0107] Figure 16 This shows a view of the first state on the projection plane;

[0108] Figure 17 A view showing the prompts in the second state of the instrument and orientation element;

[0109] Figure 18 The second state is shown as a view on the projection plane;

[0110] Figure 19 A view showing the prompts in the third state of the instrument and orientation element;

[0111] Figure 20 The view of the third state on the projection plane is shown;

[0112] Figure 21 An orientation element for a third embodiment of the first implementation is shown;

[0113] Figure 22 The image shows a device with an integrated orientation element for use in a second embodiment of the present invention.

[0114] Partial schematic diagram; and

[0115] Figure 23 A view is shown to illustrate one embodiment of the second implementation. Detailed Implementation

[0116] Figure 1 A flowchart is shown for a general embodiment of guiding a medical device, here a needle, to a target area, including the prompting method according to the invention in steps S2 to S7.

[0117] In step S1, performed before the prompting method begins, the medical device is pushed into the examination object, such as a patient or examination phantom. This can be performed according to a pre-planned device trajectory, i.e., a planned trajectory, which, as is known in principle, has been planned based on planning image data (possibly corresponding to pre-planned image data mentioned later). Here, the planned trajectory can be set by means of laser guidance performed using a light guide device also used in the prompting method below, and then the medical device is further introduced into the examination object a certain distance according to the planned trajectory. However, since this process, as well as other (intentional or unintentional) movements within the intervention area where the device target (target area) also exists, may cause variations, it is not always possible to reach the target area via the planned trajectory.

[0118] However, the method described here does not necessarily require planning, which means that users, such as doctors, can initially advance the medical device a first distance without guidance or in real-time imaging, and still reliably reach the target area based on subsequent prompting methods.

[0119] In the first step, S2, of the method according to the present invention, when the medical device has been partially introduced into the object of examination, an imaging device controlled by the recording unit of the processing apparatus of the interventional device performing the intervention records image data of the interventional area as a control scan. This can be three-dimensional recording, such as a computed tomography scan, but it is also possible to record one or more two-dimensional images as image data, for example, when using a C-arm X-ray device, recording two-dimensional X-ray images (especially fluoroscopic images) from different projection directions (angles), i.e., through different recording geometries. If necessary, the recording may also include reconstruction of the image, such as an axial slice image mapping the interventional area in a computed tomography scan.

[0120] If pre-existing image data of the intervention area, especially in three dimensions, exists, its image information is useful for subsequent analysis and allows for rigid or preferably flexible registration with the pre-existing image data, such as a planned image dataset. In the case of flexible registration, the registration transformation already includes information about possible anatomical deformations in the intervention area; in the case of rigid registration, only simple translational movements can be inferred.

[0121] Then, in step S3, using conventional analysis methods, the image data is analyzed in the analysis unit of the processing device, particularly in conjunction with pre-registered image data. For example, segmentation algorithms, location determination algorithms, classification algorithms, detection algorithms, etc., can be used.

[0122] Within the scope of the analysis, positioning information for at least partially elastically bendable elongated medical devices is first determined. This positioning information may include, for example, […].

[0123] - The posture of medical devices

[0124] - The shape of the medical device (e.g., as a centerline and / or as a functional description of the shape) (in this case, having a certain degree of flexibility).

[0125] - The location of the distal and proximal ends of the instrument, wherein, when the proximal portion of the instrument located outside the object being examined is not visible or only partially visible in the image data, the proximal end can still be estimated based on the known characteristics of the instrument (especially its length) under the assumption of no force, and / or

[0126] - The insertion point (entry point) of a medical device into the body of the patient, as well as the portion of the medical device located inside the patient (distal portion) and the portion located outside the patient (proximal portion).

[0127] In step S3, anatomical information can also be determined by analyzing image data, especially the orientation of the target region (instrument target), the orientation of anatomical structures, and / or the orientation of the boundaries and / or planned trajectories (if present) of organic structures (e.g., organs) within the anatomical structures.

[0128] The determination of anatomical information can be performed at least in part with regard to the pre-registered image data, especially if these anatomical structures have been segmented and / or labeled in the pre-registered image data.

[0129] Then, in step S4, simulation and / or model calculations are performed to determine how positional corrections, including device bending, at the proximal portion of the device, particularly at the proximal end, affect the attitude and shape of the device within the examined object, i.e., the distal portion. Specifically, this involves pre-calculating what kind of trajectory might be generated as a continuing trajectory in the presence of positional corrections and advancement of the medical device. In addition to these positional corrections and assigned continuing trajectories, the future trajectory of the medical device formed without positional corrections, and the future trajectory formed when the medical device advances without positional corrections at the proximal end, is also pre-calculated. All these calculations are performed taking into account the flexibility of the medical device, and therefore, characteristic data describing the elastic flexibility of the medical device. This characteristic data may, for example, include mechanical parameters and / or elastic parameters. The characteristic data may be based on standard assumptions, but preferably, it is retrieved based on device information provided, for example, inferred from user input, such as from a database and / or lookup table. For example, the device information may describe the model and / or type and / or class of the medical device.

[0130] The choice of which positional corrections to make and how to determine at least one continuation trajectory depends on the specific method chosen. If a medical device has a directional element with a projection surface, and multiple different markers describing positional corrections known in the analysis unit are placed on the projection surface, then a continuation trajectory can be determined for all these markers and the assigned positional corrections. However, if a specific positional correction is suggested on the projection surface, for example by a light pattern from a light guide device operable by a control unit, then the positional correction can also be determined, for example in an optimization method, to reach the target area as accurately as possible.

[0131] Finally, for each continuation trajectory individually or for all continuation trajectories as a whole, the recommended advance distance to the next control scan can be determined in step S4, for example, based on a reliability value showing the pre-calculated reliability for the one or more continuation trajectories at that distance.

[0132] Furthermore, in all these analyses, the orientation of the point of action used to perform position correction on the proximal portion of the device is also considered. Preferably, the orientation of the point of action is that on the proximal end of the medical device. Depending on the orientation of the point of action, the proximal portion may exhibit other shapes, particularly curvature, which are considered accordingly.

[0133] In step S5, an illustration is generated by the output unit of the processing device and output through a presentation device, such as a monitor, which can be easily viewed by a person manually operating the medical device. The illustration is based on image data, such as the axial layer image already mentioned, and therefore has a specific presentation orientation (as the image plane of the image data in the illustration). The illustration also displays the medical device and anatomical structures in the interventional area through image data, wherein, for better identification, the medical device and anatomical structures can be emphasized and / or contrasted, especially where the medical device and anatomical structures have been segmented and their boundaries are known. Corresponding methods for generating appropriate illustrations are known. In any case, the illustration also includes, for example, overlaying graphic elements whose positions are precisely and progressively displayed to show at least one continuing trajectory and a future trajectory. If a proposed advancement distance is determined, the advancement distance can also be output. Different embodiments will be discussed in more detail below.

[0134] In optional step S6, at least one continuing trajectory can be selected based on user input. This is particularly suitable when multiple continuing trajectories have been determined and the possibility of selection through the identification of appropriate markers or distinguishable projection points is not specified, as will be discussed below. Selection can be achieved, in particular, by evaluating the continuing trajectories illustrated.

[0135] Finally, in step S7, a positioning prompt is output to set a corresponding manual position correction on the proximal portion of the medical device so that, upon further insertion of the medical device, it reaches the selected continuation trajectory among the at least one continuation trajectory. This positioning prompt is formed by observing the overall light pattern emitted by the light guide device on the projection surface, at least one mark on the projection surface, and, if necessary, illustrations. Since different methods can be considered for this purpose in the prompting method according to the invention, these methods will be combined... Figures 4 to 23 To elaborate in detail.

[0136] Thus, the prompting method ends, and in the steps following the prompting method, the person performing the intervention, i.e., the user, performs position correction by following the positioning prompts, thereby establishing conditions for the selected continuation trajectory, and then the medical device is further advanced toward the device target by manual advancement, for example, by the suggested advancement distance.

[0137] Then, in step S9, it is checked whether the instrument target, especially the target area, has been reached and whether the intervention can continue for the reason. Therefore, the actual reason for intervention can be determined in step S10. Otherwise, the prompting method, including a new control scan, will be executed again, i.e., steps S2 to S7, to help the user reach the instrument target. It should be noted that the control scan can, of course, have already been performed as a basis for step S9.

[0138] Figure 2 The main components of the interventional device 1 according to the invention are shown in the form of a schematic diagram. The interventional device 1 primarily includes a medical instrument 2, with a directional element 3 fixed to or integrated into the medical instrument 2. The medical instrument 2 is designed as a needle 4. Here, the imaging device 5 is a computed tomography device with a gantry 6, and a light guide device 7 is arranged on the gantry 6. The light guide device 7 may have one or more laser sources for generating laser fans and / or laser beams to form a light pattern when aligned accordingly with the projection surface.

[0139] The patient can be moved from the patient's bed 8 into the gantry 6.

[0140] Presentation device 9 is designed here as monitor 10.

[0141] The operation of the intervention device 1, particularly for performing the prompting method, is controlled by the processing unit 11, the functional structure of which is as follows: Figure 3 The details are elaborated below. In addition to the storage device 12, the processing device 11 first includes a recording unit 13 for manipulating the imaging device 5 to record image data and, if necessary, register the image data with pre-existing image data and / or for reconstructing volumetric and / or layer images, particularly axial computed tomography layer images. In other words, the recording unit 13 is designed to perform step S2. The analysis unit 14 is designed to analyze the image data and determine the continuing trajectory according to steps S3 and S4, and, if necessary, the future trajectory and suggested advance distance. The output unit 15 is designed to generate and output a diagram according to step S5, while the manipulation unit 16 is used to manipulate the light guide device 7, particularly within the scope of step S7. Of course, other functional units or sub-functional units may also be considered.

[0142] Figure 4 A schematic view of the instrument 2 is shown, on which an orientation element 3 is mounted, specifically at the proximal end. The orientation element 3 forms a projection surface 17 on its upper side. If the dashed line 18 is taken as the boundary of the object to be examined 19, then the medical instrument 2—which here is a needle 4 with an elastically bendable elongated instrument rod 20—has a proximal portion 21 and a distal portion 22 with a distal end 23, which should reach the instrument target, i.e., the target area.

[0143] Figure 5A possible design for the light guide device 7 on the gantry 6 is illustrated by way of example. Here, the light guide device 7 has a laser source for generating two laser fans 24 and 25, wherein, for example, laser fan 24 is capable of displaying the orientation or position of the reconstructed axial layer on the object being examined in the form of an azimuth line, at least during the basic operation of the imaging device 5. The center of the gantry 6 or the imaging device 5 can be displayed by the laser fan 25. The laser source may be equipped with actuators to adjust laser fans 24 and 25; their relative positions can also be adjusted by manipulating the patient bed 8 via the control unit 16.

[0144] Of course, in order to project a light pattern suitable for the design scheme discussed in detail below onto the projection surface 17, various other designs for the light guide device 7 can also be considered. In particular, a laser source can be provided, which is used to project a laser beam and thus serves as a supplementary projection point for the azimuth line.

[0145] The first embodiment (for which some embodiments will now be described) specifies that a light pattern marks projection points, and in order to select a chosen continuation trajectory, the projection points need to be aligned with the markers assigned to the selected continuation trajectory. For this purpose, the output unit 15 is designed to generate a diagram with marker information assigned to at least one continuation trajectory and describing the assigned markers. Appropriately, in the embodiments of the first embodiment shown below, operation is performed within a layer of an axial layer image, which also forms the basis of the diagram.

[0146] Figure 6 The first embodiment shows a possible design for the projection surface 17 of the orientation element 3. The projection surface has markings in the form of crosshairs, wherein the crosshairs are formed by two mutually perpendicular extending orientation lines 26. Concentric circles or rings 27, 28, and 29 extend around the center of the crosshairs, and the circles or rings are applied with different colors (as different optical properties), for example, circle 27 is green, circle 28 is blue, and circle 29 is purple. Circle 30 represents the outer edge. It can be seen here that circles 27 to 29 intersect with the orientation lines 26 multiple times.

[0147] Figures 7 to 12 Explain how to use the orientation element 3 to output positioning prompts, where, Figure 13A possible illustration 31 is shown on the presentation device 9. It can be seen here that illustration 31 is based on image data 32, in which anatomical structures and medical device 2 are partially visible. The central graphic element 33 displays the future trajectory, while the graphic elements 34, 35, and 36 adjacent to it in two directions display the continuing trajectory. Here, graphic element 33 is kept in a color not appearing in circles 27, 28, and 29, such as orange, while the distinguishable optical characteristics of graphic elements 34, 35, and 36 correspond to the distinguishable optical characteristics of circles 27, 28, and 29, respectively. In other words, graphic element 34 is green, graphic element 35 is blue, and graphic element 36 is purple. Therefore, graphic elements 34, 35, and 36 not only show the direction of the continuing trajectory but also contain marking information (color) to assign corresponding markings on the projection surface 17 of the orientation element 3.

[0148] This achieves an explicit assignment (or one-to-one correspondence) of the markers by deviating from the future trajectory in the direction of the corresponding continuation trajectory, while the markers should remain in the layer of the axial layer image.

[0149] Figure 7 and Figure 8 The first case is now shown, in which the light pattern (see...) Figure 8 A cross is also formed here (by the azimuth line 37 and the projection line 38 perpendicular to it), but it is not the same as the cross of the orientation line 26 of the cross. The azimuth line 37 shows the orientation of the image, that is, the orientation of the image plane of the axial layer image, and can be easily identified by the user according to the arrangement of the imaging device 5 and the examined object 19 on the patient bed 8. By manipulating the light guide device 7 and / or the patient bed 8, the direction of the cross beam 39 (see Figure 7 The direction of the light pattern formed by the directional line 37 and the projection line 38 is at least aligned with the longitudinal direction of the proximal portion 21 of the device 2, so that the intersection of the representative projection point 40 of the light pattern formed by the directional line 37 and the projection line 38 corresponds to the intersection of the directional line 26.

[0150] If passed Figure 9 and Figure 10 As shown, the user now rotates the orientation element 3 such that (see...) Figure 10 One of the orientation lines 26 lies on the azimuth line 37, and the other orientation line 26 lies on the projection line 38. The intersections of circles 27, 28, and 29 with the azimuth line 37 or the corresponding orientation line 26 are marked as target points such that when the projection point 40 coincides with the corresponding target point, a position correction is formed, which achieves a corresponding color-coded continuation trajectory in the corresponding direction.

[0151] This is because the continuation trajectory is determined precisely based on these positional corrections given through the target point in the layer. Since the orientation of the markers, specifically circles 27, 28, and 29, is known, the positional corrections formed in the layer are also known, and the corresponding continuation trajectory can be determined in step S4, taking into account the point of application. Here, the user can intuitively and clearly perceive the corresponding direction and its effect, as well as which of lines 37 and 38 is azimuth line 37, since the object under inspection 19 is correspondingly in front of it and the illustration also involves this layer.

[0152] As in Figure 11 and Figure 12 As shown in the first embodiment, the user selected a continuation trajectory based on the lower graphic element 35 (blue) because this trajectory is closest to the target area. Therefore, position correction was performed at the point of action located at the proximal end of the device 2, such that the projection point 40 is as shown. Figure 12 The location shown is at the left intersection of the blue circle 28 and the orientation line 26, which coincides with the azimuth line 37. If progress is made now, the trajectory will be adjusted to form a continuous path as shown by the lower graphic element 35. Here, the medical device 2 remains in the axial layer, which is presented as a layer image of image data 32, which is the basis for illustration 31; therefore, no changes are required for further control scanning or for the azimuth line 37.

[0153] In particular, if, as shown, it should always operate in a fixed, preset layer, the projection surface 17 of the orientation element 3 can also be used, as for... Figure 14 The design scheme shown in the second embodiment is as follows. Here, the projection plane 17 is maintained along the direction of the (only one) directional line 26, and the circles 27, 28, and 29 are reduced to lines 41 (green), 42 (blue), and 43 (purple) perpendicular to the directional line 26.

[0154] In the second embodiment, the adjustment possibilities for the second laser fan 25 or the patient's bed 8 are, for example, insufficient to meaningfully position the projection point 40 at the center of the projection surface 17. Therefore, in addition to continuing to display the azimuth line 37 indicating the orientation of the axial layer, the light guide also projects the azimuth point 45 onto the projection surface 17 via a laser light source for outputting the laser beam 44 to form a light pattern and define the projection point 40. The laser beam 44 and the laser fan 24 may have different colors.

[0155] Figure 15 and Figure 16 The original state (first case) is shown again, where azimuth line 37 and orientation line 26 are not aligned, but projection point 40 is now located at the center intersection of the markers. Figure 17 and Figure 18In the second case, the orientation element 3 is rotated such that the azimuth line 37 and the orientation line 26 overlap. The intersections of lines 41, 42, and 43 with the orientation line 26 are now aligned with... Figure 9 and Figure 10 Similarly, to illustrate the target points, projection point 40 needs to move to these target points in order to select the continuation trajectory that is displayed as graphic element 34, 35 or 36 in Figure 31.

[0156] In accordance with Figure 19 and Figure 20 In the third case, through the corresponding position correction, the continuation trajectory assigned to (or belonging to) the lower graphic element 35 was selected again, because the projection point 40 is now located on the target point defined by the line 42 (blue) on the left.

[0157] Figure 21 A third embodiment of the first implementation is shown, in which, in addition to the cross formed by the directional line 26 and another line 46, a point 47 is also provided as a marker for a matrix arrangement of coordinate grids with corresponding names. For example, the graphic elements 34, 35, and 36 can be assigned the coordinates of the corresponding point 47 as target points, as the marker information in Figure 31. The opposite explanation is also possible if, for example, the projection point 40 cannot be set at the intersection of the directional line 26 and the other line 46.

[0158] In the second embodiment, it is sufficient to have at least one mark on the projection surface 17 to display the orientation point, because the control unit 16 controls the light guide device 7 to mark the projection point assigned to the continuation trajectory on the projection surface 17 so that the projection point and the orientation point need to be coordinated in order to select the assigned continuation trajectory, i.e., to adjust and form the necessary position correction.

[0159] In this case, it is possible to consider designing simpler markings. Figure 22 An embodiment of integrating the orientation element 3 into the device 2 is shown, with the proximal end face serving as the projection surface 17.

[0160] Figure 23 This marking is shown more precisely, defining an orientation point 48 at its center (corresponding at least to the longitudinal direction of the proximal portion 21 without position correction). The projection point 49 is significantly offset from the orientation point as part of the light pattern. If, at the current position of the point-of-action correction device 2, the orientation point 48 and the projection point 49 are aligned, then position correction is performed to achieve the continuation trajectory assigned to the projection point 49, and this can be achieved by advancing.

[0161] In the case of a single projection point 49, the marking information in Figure 31 can individually emphasize the assigned continuation trajectory, while in the case of multiple projection points 49, the assignment can also be achieved through distinguishable optical characteristics.

[0162] Especially in the embodiment of the second implementation that uses only one projection point 49, the use of optional step S6 is meaningful so that, for example, the desired continuation trajectory has already been selected in Figure 31, and then the appropriate projection point 49 is obtained by projection to output positioning cues.

[0163] However, it is also possible to automatically determine or select the most suitable continuation trajectory for reaching the instrument target, display it in Figure 31, and project a suitable projection point 49 through the guide device 7.

[0164] Although the present invention has been described and illustrated in more detail through preferred embodiments, the present invention is not limited to the disclosed embodiments, and those skilled in the art can derive other variations therefrom without departing from the scope of protection of the present invention.

[0165] Regardless of the gender of the grammar of a particular term, people with either male or female gender identities are included.

Claims

1. A medical interventional device (1), having - An elongated medical device (2) capable of being partially introduced into the intervention area of ​​the subject (19) for intervention, the medical device having a proximal portion (21) for manual operation of the medical device (2) that needs to be arranged outside the subject (19) and is at least partially flexible. - An orientation element (3) arranged on and / or integrated in the instrument (2), the orientation element having a projection surface (17) marked with at least one mark indicating at least one point, - Presentation device (9), Its features are, The medical interventional device (1) has - Processing apparatus (11), the processing apparatus having: - Analysis unit (14), the analysis unit being designed to determine at least one predictive continuation trajectory, using image data (32) of the examination object (19) presenting the intervention area and positioning data describing the current position and orientation of the medical device (2), in the case of characteristic data describing the flexibility of the medical device (2), and - Output unit (15), the output unit being used to output on the presentation device (9) a diagram (31) of the intervention area and at least one continuing trajectory based on image data (32); and - A light guide device (7) for projecting at least one light pattern onto a projection surface (17) such that by observing at least one of the at least one mark and the light pattern as a whole, a positioning cue is formed for manual position correction on the proximal portion (21) of the medical device (2) so as to achieve the selected continuation trajectory of the at least one continuation trajectory during further insertion of the medical device (2).

2. The interventional device according to claim 1, characterized in that, The light pattern marks projection points (40). In order to select the selected continuation trajectory, the projection points need to be consistent with the markers assigned to the selected continuation trajectory. The output unit (15) is designed to generate a diagram (31) with marker information assigned to at least one continuation trajectory and describing the assigned markers.

3. The interventional device according to claim 1, characterized in that, The light pattern includes at least one azimuth line (37) that shows the orientation of the illustration (31).

4. The interventional device according to claim 3, characterized in that, The azimuth line (37) is the image plane of the layer used in the image data (32) in the illustration (31).

5. The interventional device according to claim 2, characterized in that, In order to mark the projection point (40) on the azimuth line (37), the light pattern includes an azimuth point (45).

6. The interventional device according to claim 5, characterized in that, The location point can be controllably adjusted based on the positioning information by the processing device (11).

7. The interventional device according to claim 3, characterized in that, The marker has at least one orientation line (26) that needs to coincide with the azimuth line (37).

8. The interventional device according to claim 7, characterized in that, Markers that can be assigned to the continuing trajectory are provided along the orientation line (26), so that in the orientation line (26) which coincides with the orientation line (37), for each position correction, the medical device (2) remains in the layer marked by the orientation line (37).

9. The interventional device according to claim 7, characterized in that, - The marking forms at least a portion of a crosshair comprising at least one directional line (26), the center of which coincides with the projection point (40) before position correction is performed, and loops (27, 28, 29) of the crosshair are assigned to corresponding continuation trajectories, and / or - The markers form a coordinate grid, wherein at least the markers that can be assigned to the continuation trajectory are assigned coordinates.

10. The interventional device according to claim 1, characterized in that, The orientation element (3) has only one mark defining the orientation point (48), and the processing device (11) is designed to manipulate the light guide device (7) to mark the projection point (49) assigned to the continuation trajectory on the projection surface (17). In order to select the assigned continuation trajectory, the projection point needs to be aligned with the orientation point (48).

11. The interventional device according to claim 1, characterized in that, The proximal portion (21) has a point of action for manually performing position correction, wherein the analysis unit (14) is designed to take into account the attitude of the point of action when determining the at least one continuing trajectory.

12. The interventional device according to claim 1, characterized in that, The interventional device has an imaging apparatus (5) for recording at least a portion of image data (32).

13. The interventional device according to claim 12, characterized in that, The light guide device (7) is fixedly mounted on the imaging device (5) and / or integrated into the imaging device.

14. The interventional device according to claim 1, characterized in that, The analysis unit (14) is designed to determine positioning data from the image data (32) at least in part and / or to register the image data (32) with pre-image data of the provided object to be inspected (19).

15. The interventional device according to claim 1, characterized in that, The analysis unit (14) is designed to determine characteristic data from the provided instrument information.

16. A computer-implemented method for determining and outputting positioning prompts for an elongated medical device (2), the medical device being partially introduced into an interventional area of ​​an examination subject (19) for intervention, the medical device having a proximal portion (21) for manual operation of the medical device (2) that needs to be disposed outside the examination subject (19) and is at least partially flexible, wherein, Using an orientation element (3) arranged on and / or integrated in the instrument (2), the orientation element having a projection surface (17) with at least one mark indicating at least one point, wherein the method has the following steps when the instrument (2) has been partially introduced into the object to be examined (19): - Image data (32) of the interventional area of ​​the object to be examined (19) is provided through the interface of the processing device (11), and positioning data is determined, which describes the current position and orientation of the medical device (2). - Using the analysis unit (14) of the processing device (11), at least one predictive continuation trajectory is determined from image data (32) and positioning data, taking into account characteristic data describing the flexibility of the medical device (2). - Using the output unit (15) of the processing device (11), an illustration (31) of the intervention area and at least one continuing trajectory based on image data (32) is output on the presentation device (9); and - The light guide device (7) is operated in such a way that at least one light pattern is projected onto the projection surface (17) such that by observing at least one of the at least one mark and the light pattern as a whole, a positioning cue is formed for manual position correction on the proximal portion (21) of the medical device (2) so as to achieve the selected continuation trajectory among the at least one continuation trajectory during further insertion of the medical device (2).

17. An electronically readable data carrier having a computer program stored thereon, which, when executed on a processing device (11) of an intervention device (1), causes the processing device to perform the steps of the method according to claim 16.

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