Medical intervention device, method for determining and outputting positioning

Abstract

The invention relates to a medical intervention device (1) comprising a bendable medical instrument which can be introduced into an intervention region of an examination object and which has a proximal end portion for operation, an orientation element on the instrument, which has a marked projection surface, a presentation device, and a processing device, which has: an evaluation unit, which evaluates the position of the medical instrument; -an output unit designed to determine a predictive continuation trajectory from image data representing the interventional region and positioning data describing the current position and attitude of the instrument, using characteristic data describing the flexibility of the instrument, and-an output unit designed to output the predictive continuation trajectory from the image data representing the interventional region and the positioning data describing the current position and attitude of the instrument, an output unit for outputting an image data-based representation of an intervention region and a continuation trajectory on a presentation device; and-a light-guiding device for projecting a light pattern onto a projection surface in such a way that a positioning prompt for position correction on the proximal end portion of the instrument is formed in order to achieve at least one continuation trajectory during further insertion of the instrument.

Description

Technical Field

[0001] The invention relates to a medical interventional device having an elongated medical instrument that can be partially introduced into an interventional area of ​​an object to be examined for intervention, the medical instrument having a proximal portion that needs to be arranged outside the object to be examined for manual operation of the medical instrument and is at least partially bendable. In addition, the invention relates to a computer-implemented method and a computer program for determining and outputting positioning instructions. Background Art

[0002] In the prior art, elongated medical instruments are known, which are inserted into a patient for the purpose of examining and / or treating the patient. In this context, needles, such as biopsy needles, excision needles and similar needles, are referred to as medical instruments. It is generally provided that the needle is moved inside the object under examination in such a way that the tip of the needle reaches a target region of the object under examination, in particular a target object. The target region may be, for example, a tumor or other tissue of interest and / or tissue to be treated. In order to reliably reach the target region, in particular to assist the user of the manually guided instrument, a number of effects need to be taken into account.

[0003] Therefore, for example, it is necessary to consider that when an instrument, especially a needle, is inserted into soft tissue, the soft tissue is usually not statically unchanged. On the one hand, it is the movement in the object of examination, such as the macroscopic movement and / or circulatory movement of the patient, such as respiratory movement and heartbeat. On the other hand, the instrument itself may also cause tissue movement. Therefore, for example, organs and / or other anatomical structures may be pressed to the side and / or to the rear and / or other deformations may occur. Therefore, users, such as interventional radiologists, usually do not use navigation when guiding the needle, but guide the needle (or other instruments) forward step by step, interrupted by repeated imaging, especially X-ray imaging and path correction. It is known here, for example, that in order to correct the instrument path, the proximal part of the instrument that has been partially inserted, that is, the part pointing to the user, is moved laterally so that the instrument is then pushed forward a section. If the path of the instrument deviates greatly from the desired path, the instrument can be pulled back a section and re-corrected. Such corrections of the instrument path are based on the intuition and experience of the user, wherein each correction of the instrument path affects the tissue of the examination subject, prolongs the duration of the intervention and increases the radiation exposure due to repeated image acquisitions by x-ray imaging.

[0004] Depending on the diameter, material and flexibility, i.e. the mechanical properties, of the instrument, the lateral movement of the proximal end of the instrument results in a rigid change of direction of the already partially inserted instrument within the anatomical structure or an elastic bending of the instrument, thereby achieving a curved needle path. There are also relatively wide transition regions in which both a change of direction and a bending occur. All of these estimates have hitherto been left to the experience and intuition of the user.

[0005] The most commonly used method today for interventions with medical instruments, in particular needles, is the so-called "step-and-shoot method", as already explained above. Here, the needle is advanced step by step and the position is checked regularly by X-ray imaging, wherein the needle is redirected accordingly whenever it cannot reach the target area with the current orientation. It is then advanced a little further and a new check scan is performed. However, this requires a lot of experience on the part of the user.

[0006] In the prior art, it is also proposed to carry out pre-planning, in which a static and straight needle trajectory is planned, for example, in a three-dimensional pre-image data set of the examination object. The planned needle trajectory can be displayed visually in order to carry out the intervention by visual navigation, wherein, for example, crossed laser lines can display the needle trajectory. However, in this method, there is neither adaptation to possibly changing anatomical structures nor consideration of the flexibility of the instrument, in particular the needle.

[0007] Finally, it has been suggested in the prior art that the introduction of instruments, in particular needles, is performed by a robot. For example, it is suggested that the robot gradually advances the needle and performs an inspection scan by means of a computed tomography scan. Here, the current position and shape of the target area within the anatomical structure and, if necessary, the current posture are determined in the image data, whereby an adapted needle path and a corrected curvature of the part outside the patient are automatically calculated. The robot is then controlled according to the adapted needle path. After performing these steps multiple times, the needle automatically reaches the target area with the aid of a curvature adapted to the changes in the anatomical structure. For example, WO 2022 / 254436 A1 discloses a system, device and method for updating in real time a trajectory at a target for introducing a medical device into an object body, wherein control is achieved according to a closed control loop toward the moving target.

[0008] For the use of rigid screws, it has already been proposed to generate a graphic representation to assist the user, which shows by superimposing the image data in which direction the screw would move if it were pushed straight forward further into the examination object. Summary of the invention

[0009] The object of the present invention is to provide a user with intuitive support when manually advancing a medical instrument into an examination object, which support enables in particular a rapid and reliable approach to the target area.

[0010] This technical problem is solved according to the invention by a medical intervention device, a computer-implemented method and a computer program. Advantageous embodiments emerge from the description.

[0011] The present invention is described in detail below according to the medical intervention device, method and computer program. Here, the description of the corresponding invention solution can be transferred to each other similarly, so in particular the design and description of the medical intervention device can also be transferred to the computer-implemented method and vice versa.

[0012] The medical intervention device according to the present invention comprises:

[0013] an elongated medical instrument which can be partially introduced into an intervention area of ​​the examination subject for the purpose of intervention, which has a proximal end portion which needs to be arranged outside the examination subject for manual handling of the medical instrument and which is at least partially bendable, in particular elastically,

[0014] an orientation element arranged on the instrument and / or integrated in the instrument, the orientation element having a projection surface with at least one marking which marks at least one point,

[0015] - presentation device,

[0016] - a processing device, the processing device comprising:

[0017] an analysis unit designed to determine at least one predictive, in particular non-linear, continuation trajectory from image data of the examination object representing the intervention region and positioning data describing the current position and posture of the medical instrument, using characteristic data describing the flexibility of the medical instrument, and

[0018] an output unit for outputting a representation based on the image data of the intervention region and of the at least one continuation trajectory on a presentation device; and

[0019] - A light-guiding device for projecting at least one light pattern onto a projection surface in such a way that, by observing at least one of the at least one marking and the light pattern as a whole, a positioning prompt for manual position correction on the proximal part of the medical device is formed so as to achieve a continuation trajectory to be selected from the at least one continuation trajectory during further advancement of the medical device.

[0020] The examination object can be, for example, a human and / or animal patient and / or an examination phantom. Therefore, it can also be understood that the medical intervention device according to the present invention of the medical intervention system has a plurality of components, through the interaction of which it is possible to output an intuitive, auxiliary positioning prompt.

[0021] The medical device is in particular a surgical device and is preferably a needle, in particular a puncture needle. Other conceivable medical devices include drills, screws, diagnostic devices such as endoscopes and / or catheters, and / or saws. The medical device is elongated, therefore elongated and preferably needle-shaped and / or rod-shaped. In the operating state of the device, the medical device is preferably arranged at least partially inside the object under examination, in particular in the intervention area. The part of the medical device arranged inside the object under examination is also referred to as the distal part.

[0022] The orientation element can be arranged on a medical device, in particular a proximal section of the medical device, in a defined posture relationship, in particular a defined spatial relative position and / or relative orientation and / or relative posture. The orientation element and / or the medical device can have a fixing element, such as a clamping device and / or a plug-in device and / or a magnetic holder. Alternatively or in addition, the orientation element can be at least partially integrated into the medical device, in particular on the proximal part, for example on the surface of the medical device.

[0023] The orientation element has a projection surface, on which at least one mark is arranged. In addition to the mark, the projection surface can be painted with a specific color, such as white. The projection surface is formed in particular by at least a part of the visible surface of the orientation element. At least one mark marks at least one point and can be at least dot-shaped. At least one mark can be designed as a geometric object, such as a line and / or a circle and / or a cross. In addition, at least one mark can be designed as a contrast object, such as an imprint and / or a protrusion and / or a recessed portion on the substrate of the orientation element, in particular on the surface of the orientation element.

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

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

[0026] Advantageously, the image data include a two-dimensional or three-dimensional spatially resolved mapping of the object under examination. The image data may also map the object under examination in a time-resolved manner. The image data may include a plurality of image points, in particular pixels or voxels, which have image values, such as intensity values ​​and / or attenuation values, which map, in particular represent, the object under examination. The image data preferably include X-ray image data, in particular computed tomography image data sets and / or projection images, such as fluoroscopic images, of the object under examination. The image data may also, expediently, at least partially map a medical device.

[0027] The presentation device may comprise a screen and / or a display and / or a projector and / or data glasses which are designed to display the graphical representation.

[0028] The light guide device can advantageously include a light source, in particular a laser light source, which is designed to emit a light pattern. For this purpose, the light guide device can include an aperture, for example. As will be described in detail below, the processing device can have a control unit for controlling the light guide device. The light guide device can be designed in particular to emit at least one laser fan and / or at least one laser beam for projecting a line or a point. The light guide device can have at least one actuator in order to achieve a change in the light pattern. The control implemented by the control unit can involve the actuator.

[0029] If the object to be examined is supported on an adjustable patient couch, the relative position and orientation of the light pattern can also be controlled by actuators of the patient couch. For example, designs are known in which the two laser fans, and therefore the lines in the light pattern, represent the position of the recorded (usually axial) slices of the computed tomography and the center of the imaging device, here the computed tomography device. The center line can then also be positioned as required by adjusting the patient couch laterally.

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

[0031] The analysis unit is designed to determine the continuation trajectory generated in the specific position correction and further advancement on the proximal part. The illustration allows the user to evaluate at least one continuation trajectory, and the positioning prompt is used to guide the user to perform these position corrections for the (selected) trajectory. Since the (current) image data are taken into account, the current state of the anatomical structure of the inspection object in the intervention area is included here. However, according to the present invention, it is not assumed that the medical instrument is rigid, but these mechanical properties that allow flexibility are also assigned to actual, especially elastic, bendable instruments when determining at least one continuation trajectory, so as to form a reliable and accurate prediction and at the same time, when manually guiding the medical instrument, especially the needle, it is also related to the characteristics or degrees of freedom that have been intuitively considered by the user so far, that is, the flexibility of the instrument is assisted by the user. Thus, a three-dimensional evaluation can be performed in particular during the determination. Here, the flexibility of the instrument is not particularly limited to the proximal part, but also includes the distal part that is introduced or can be introduced into the patient's body, so that curved shapes may also / should appear in the patient's body.

[0032] It can be specifically provided here that the analysis unit is designed to determine at least one continuation trajectory by simulating and / or modeling the influence of the position correction of the medical device performed in the proximal part, especially including the bending, on the behavior of the device at the distal part of the inspection object, especially when advancing. If, as will be explained in detail below with respect to the first embodiment, the mark should be assigned to a specific continuation trajectory, the curvature in the proximal part can be preset so that the position correction described by the corresponding mark is used. Alternatively or additionally, it can also be considered that the target information about the instrument target in the intervention area, especially the target area, is provided to the analysis unit, and the analysis unit is designed to determine at least one continuation trajectory for getting as close as possible to the instrument target and the position correction required for this (especially including the curvature of the proximal part). In the second embodiment that will be described in detail below, the projection point can show this point. For example, in the above-mentioned first embodiment, the nearest mark describing the position correction can be determined by the analysis unit. The curvature at the proximal part will also lead to the curvature at the distal part.

[0033] In the illustration on the presentation device, the continuation trajectory that can be understood as a virtual continuation can be presented, for example, as an image data superimposed with accurate position. In this case, the continuation trajectory can be displayed as a graphical element, in particular a line and / or an arrow. In this case, the continuation trajectory can in particular extend at least partially nonlinearly, for example in a curved manner.

[0034] In this way, the correction of the instrument path is greatly simplified, especially for inexperienced users, and the intervention can be performed more time-saving and with less radiation. In this way, in particular, an improved "step-and-shoot" method is provided, wherein the consideration of the flexibility of the medical instrument and the associated provision of positioning instructions as workflow instructions provide significant added value.

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

[0036] As mentioned above, within the scope of the present invention, two alternative embodiments are conceivable as to how positioning instructions can be output to the user in an intuitive and targeted manner by means of light patterns and at least one marking.

[0037] In a preferred first embodiment, it can be provided that the light pattern marks a projection point, and in order to select the selected continuation trajectory, it is necessary to make the projection point consistent with the mark assigned to the selected continuation trajectory, wherein the output unit is designed to generate a diagram with mark information, which is assigned to at least one continuation trajectory and describes the assigned mark. In particular, it can be provided that in order to make the projection point consistent with the mark, the target point defined by the mark coincides with the projection point. In the case of multiple continuation trajectories and multiple marks, the mark and the mark information can be optically distinguished. In other words, it can be provided that the mark has optically distinguishable characteristics. In order to output the mark information, the continuation trajectory can also be represented (or presented) with optically distinguishable characteristics, wherein, in particular, the optically distinguishable characteristics of the continuation trajectory or generally the mark information can correspond to the optically distinguishable characteristics of one of the marks in pairs. For example, multiple marks can have color coding and / or black and white coding and / or surface properties, in particular reflectivity and / or contours, as optically distinguishable characteristics, and multiple marks can be uniquely identified by optically distinguishable characteristics. In a specific embodiment, when the mark has color coding, a corresponding color can also be selected for the continuation track in the diagram.

[0038] In particular, a plurality of markings and their position on the orientation element are known to the processing device, so that the evaluation unit can be designed to specifically determine a suitable continuation trajectory for the markings and the resulting position correction, as described above, including the bending of the medical instrument at the proximal end portion.

[0039] As will be explained, the projection point can be projected, for example, along the longitudinal direction of at least the proximal part of the instrument, in particular along the rod axis of the instrument rod, in the case where a position correction has not yet been carried out. This adjustment can be achieved by controlling the light-guiding device, in particular by a control unit of the processing device according to positioning data or based on planning information. In other words, the processing device can have a control unit, which is designed to control the light-guiding device in such a way as to output a light pattern that the projection point is projected along at least the current longitudinal direction of the proximal part of the medical device, in particular along the rod axis of the instrument rod. In addition or alternatively, it can be provided that the control unit is designed to control a patient couch on which the examination object is arranged, so that the relative position and orientation of the medical device and the light pattern are such that the projection point is projected along the current longitudinal direction of at least the proximal part of the medical device, in particular along the rod axis of the instrument rod. In this case, the center point of the orientation element can appropriately correspond to the projection point, which shows the current longitudinal direction.

[0040] In this first embodiment, the orientation element can be understood as a kind of "target disk", wherein, in order to perform a position correction, in particular at a predetermined point of action, the proximal end of the medical instrument is manipulated in such a way that the projection point coincides with a marking corresponding to the selected continuation trajectory. Which marking this is is communicated by the marking information in the diagram.

[0041] In a suitable extended design of the present invention, it can be provided that the light pattern includes at least one orientation line showing the orientation of the illustration, in particular the image plane of the layer of the image data used in the illustration. For this purpose, the light guide device can be capable of being controlled accordingly by a control unit and / or be aligned with a medical imaging device that provides the image data. In particular, in a computed tomography device that usually reconstructs axial layers as layer images, the layer orientation can also be fixedly preset, so that in order to project the orientation lines in a fixed adjustment-forming manner, the light guide device can also be designed so that the orientation lines show the layer orientation. Such an orientation line can be displayed in particular by a laser fan. Therefore, when using a computed tomography device, the already provided light guide device can also be used appropriately within the scope of the present invention, which displays the layer orientation on the patient.

[0042] It should be pointed out here that in the case of a light guide device with an adjustable light fan and / or laser fan for the orientation lines, which can be controlled accordingly, the orientation lines can also be adjusted when adjusting the presentation orientation. This is particularly useful when, as is usually the case, work is not to be done in the same axial layer, but the layer can also be changed. In this case or even if, as described above, the light guide device is not originally fixedly adjusted to a (fixed) layer orientation, the control unit of the processing device can be designed to control the light guide device to project the orientation lines according to the current presentation orientation.

[0043] In this context, it can be provided that the light pattern includes further projection lines, in particular projection lines perpendicular to the orientation lines. For example, such further projection lines can show the center of the imaging device, in particular in the case of a computed tomography device. However, the further projection lines can also be suitably adjustable by corresponding actuators, for example in order to show the current longitudinal direction of at least the proximal part of the medical device. It is also conceivable that the relative position and orientation of the further projection lines can be adjusted by actuating an adjustable patient couch.

[0044] However, in a particularly advantageous extension of the first embodiment, it can be provided that, in order to mark the projection point on the orientation line, the light pattern includes an orientation point, which can be adjusted in a controllable manner by the processing device based on the positioning information. For example, such an orientation point can be preset in a simple manner by the laser beam of the corresponding laser light source of the light guide device, which indicates the position along the orientation line. It is particularly suitable that the orientation line and the orientation point have different colors. For example, a green orientation point can be used for a red orientation line. Here, the orientation point can be understood as an extended, especially at least substantially circular shape, wherein, for simple implementation, a small projection element is preferably used here. For example, the orientation point can also be a short orientation line, which can be moved along the orientation line. The position of the orientation point along the orientation line can be adjusted by actuation by means of the actuation unit of the processing device. Providing such an orientation point is an easy-to-implement and particularly suitable method mainly in the following case, that is, the lateral fixability of the patient couch is insufficient in the case of a self-adjustable additional projection line that indicates the center of the imaging device.

[0045] In a particularly expedient embodiment, it can be provided that the marking has at least one orientation line which is to coincide with the orientation line, in particular in such a way that the medical device remains in the image plane or layer represented in the diagram if the projection points remain on the coincident orientation line. This is particularly expedient if, as described above, axial layers of a reconstructed computed tomography image are used as image data. The orientation element can be rotatably arranged on the medical device in order to allow the orientation line and the orientation line to coincide; however, it is also conceivable to rotate the medical device about its longitudinal axis.

[0046] Together, the orientation lines and the position lines provide the user with an intuitive orientation that not only makes the illustration easier to understand, but also correctly assigns labels to the displayed continuation tracks. This may also be useful if, instead of working in the displayed slice as usual, you want to move out of this slice. However, you usually work in a specific slice in order to also simplify further imaging, for example when re-recording image data.

[0047] Here, the orientation element can also be designed for the work in a specific layer. For example, it can be provided that a mark that can be assigned to the continuation trajectory is set along the orientation line, so that when the orientation line coincides with the orientation line, for each position correction, the medical device remains in the layer marked by the orientation line. Here, the orientation element can be conveniently designed in an elongated shape along the direction of the orientation line. This design has proven to be particularly useful in combination with the use of projection points, because an extension of the light pattern mainly in the direction of the orientation line is formed thereby. Thus, in order to perform a position correction in a layer that also corresponds to the image plane of the diagram, it is only necessary to coincide the orientation line with the orientation line of the light pattern and align the projection point with the corresponding mark along the orientation line, which corresponds to the selected continuation trajectory in the diagram according to the marking information.

[0048] A specific embodiment within the scope of the first embodiment may also provide that:

[0049] the marking forms at least a part of a crosshair comprising at least one orientation line, the center of which coincides with the projection point before the position correction is performed, and the rings of which are assigned to the respective continuation tracks, in particular in different colors, and / or

[0050] The markings form a coordinate grid, in particular a matrix-shaped one, wherein at least the markings which can be assigned to a continuation trajectory are assigned coordinates.

[0051] The advantage of the crosshairs is that the orientation line can be quickly and easily overlapped with one of the (two mutually perpendicular) orientation lines, especially when work is supposed to be permanent in a specific layer. For example, the marking can thus form a colored circle of the crosshairs, wherein the projection point can thus move in the desired direction on the selected orientation line that coincides with the orientation line to the desired mark of the desired color given by the marking information in order to perform a position correction. It should also be generally pointed out here that when working in a layer that also forms the image plane of the illustration, it is expedient to determine two continuous tracks of a color, in particular the color of the crosshair circle, that is, one track is determined for each correction direction in the layer. By intuitive positioning with the help of the orientation lines, the user can easily and correctly assign the corresponding direction to the correction in the layer.

[0052] When markings are used in a matrix-shaped coordinate grid, for example marking points or marking circles are used in a regular matrix arrangement, the coordinate specifications can be used as marking information, for example so that for the continuation of the trajectory of B3, the projection points should be moved in B3 accordingly to the markings in the coordinate grid. However, the coordinate grid is very useful even if the projection points cannot be arranged centrally, i.e. do not necessarily always show the same direction, for example at least the longitudinal direction of the proximal part of the medical instrument, because this allows, for example, a relative allocation in the coordinate grid, for example in the manner of "one to the right, three down".

[0053] In an alternative second embodiment, a different method is selected, in which the light pattern, in particular the projection point, indicates which direction the mark (which may be a mark) should move. This means that, in this embodiment, it is provided that the directional element has only one mark defining the directional point, and the processing device is designed to manipulate the light guide device to mark the projection point assigned to the continuation trajectory on the projection surface, and in order to select the assigned continuation trajectory, it is necessary to coordinate the projection point with the directional point, that is, to coincide. This design is particularly suitable in the following case, that is, the continuation trajectory leading to the target area or instrument target in the intervention area in the best way is determined and this trajectory should be followed as accurately as possible. Then, the projection point can show which direction the directional point defined by at least one mark should move in order to perform a position correction, thereby realizing this selected continuation trajectory. However, in principle, it is also conceivable that a plurality of distinguishable projection points assigned to different continuation trajectories can be projected as part of the light pattern. In other words, the projection point can have distinguishable optical properties, which are described by marking information or whose marking information corresponds to the distinguishable optical properties of the projection point in their distinguishable optical properties, so that the continuation trajectory can be selected according to the diagram by moving the orientation point to the corresponding projection point.

[0054] In the second embodiment, it is expedient that an actuation unit is required as part of the processing device in order to appropriately actuate the light guide device and / or the patient couch so that at least one projection point correctly displays the corresponding continuation trajectory.

[0055] Specifically, it can be provided, for example, that an actuator assigned to the laser light source, for example an actuator for adjusting the laser beam or the intersecting laser plane projected into the room, is controlled in such a way that the projection point shows the movement of the proximal end of the medical instrument that must be implemented as a position correction in order to achieve a specific continuation trajectory, which is selected, for example, by user input and / or automatically. In other words, the light pattern is moved and the desired degree of curvature of the medical instrument is displayed as a new projection point.

[0056] Therefore, in the second embodiment, only one orientation element of simple design is required, and the continuation trajectory, in particular the continuation trajectory that best guides to the instrument target, can be adjusted with high precision, intuitively and easily.

[0057] It should also be pointed out here that for both embodiments, a targeted selection of one of a plurality of continuation trajectories by user input is conceivable. For example, in the second embodiment, the user can select a continuation trajectory from a plurality of suggestions, and the projection point then displays the necessary position correction for this continuation trajectory. Thus, in particular in the first embodiment, provision can be made for the marking information to be gradually displayed in the diagram only when a selection is made, for example in terms of a coordinate grid, for which an output for a relative movement in the coordinate grid can then be implemented.

[0058] In a suitable extended design of the present invention, it can be provided that the proximal part has an action point for manually performing a position correction, wherein the analysis unit is designed to take into account the posture of the action point when determining the at least one continuation trajectory. Here, the action point provided is preferably located at the proximal end of the instrument and / or adjacent to and / or on the orientation element, but other action points can also be considered. Depending on the position of the action point, and therefore depending on the position in which the user holds the medical instrument to perform the position correction, other shapes, especially with regard to bending, may appear on the proximal part, which shapes can be optimally taken into account and included in the determination of the continuation trajectory when the action point is known according to the present invention. The further outward the action point is, the more the bending characteristics of the instrument can be utilized. In an embodiment in which different action points are provided or can be used, the action point currently used can be derived, for example, from a user input.

[0059] In a preferred design, the interventional device may have an imaging device for recording at least a portion of the image data. In the prior art, such an interventional workstation has been proposed in principle, which also has an imaging device, especially for monitoring intervention. In this case, the processing device may also have a recording unit for controlling the imaging device to record image data. The use of a computed tomography device is particularly preferred, because this is known in principle, especially for guided interventions using elongated medical instruments, especially needles, and can be used, especially for the execution of planning procedures. The computed tomography device provides three-dimensional image data in a simple and fast manner, especially for axial layers including the intervention area, which three-dimensional image data also clearly show the instrument and are therefore easy to analyze. In addition to the computed tomography device, other imaging devices, especially X-ray devices, may also be considered alternatively or in addition. For example, the imaging device may also be a C-arm X-ray device, which has a C-arm, and an X-ray emitter and an X-ray detector are arranged opposite to each other on the C-arm. Different projection geometries / recording geometries can be set (or adjusted to form) using the freedom of movement of the C-arm. Of course, other imaging methods may also be used in principle.

[0060] With regard to C-arm X-ray devices or other X-ray devices that allow different recording geometries to be realized, it should also be noted that fluoroscopic monitoring is usually used here. In order to be able to identify the instrument path in all spatial directions, the recording geometry, in particular the angle of the C-arm, can be changed. Typical examples of interventions performed under fluoroscopic observation are bone biopsies, spinal fusions and vertebroplasties. In order to determine the image data from which conclusions should be drawn about the positioning of the instrument and / or anatomical structures, it can be provided in this case that fluoroscopic images of the medical instrument are recorded from at least two projection directions in order to obtain the required three-dimensional information. However, it is also conceivable to carry out C-arm CT acquisition.

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

[0062] As already mentioned, the evaluation unit for determining the localization data can be formed at least partially from the image data. In this way, no additional localization data is required and / or the localization data can be checked for plausibility. Particularly in the case of X-ray imaging, since medical instruments are high-contrast objects, such detection of the instrument and determination of the localization data can be easily achieved by conventional algorithms.

[0063] It is particularly suitable that the analysis unit is designed to register the image data with the pre-image data of the provided inspection object. Especially in the case of perspective images, in X-ray imaging, the anatomical structures of interest are also partially mapped not very clearly, while they are easily identified or segmented in the pre-image data. Therefore, in general, in a suitable extended design, it is also possible to perform registration with such pre-image data sets, such as three-dimensional computed tomography image data sets and / or magnetic resonance image data sets, wherein, in the pre-image data sets, anatomical structures, such as different types of tissues can be already segmented, or the segmented regions can be assigned with mechanical properties. However, it is preferred to determine the anatomical information describing the current state of the anatomical structures in the intervention area directly from the image data, so that, for example, the movement and / or other movements that occur can be understood. These anatomical information can also be used to update the pre-image data sets, for example, about tissue boundaries. This can also be achieved by registration itself when elastic registration is performed about the anatomical structures in the intervention area. If the image data can also display the anatomical structures clearly enough, the elastic registration can ultimately directly lead to information about the changes that occur.

[0064] The image data showing the current situation with the partially introduced medical instrument can generally be data of a control scan, in particular. As described above, the localization data can be determined from the image data within the scope of the analysis, wherein the following analysis information can be obtained by analyzing the image data (in particular together with previous image data rigidly or preferably elastically registered therewith), preferably by conventional image analysis methods, in particular including segmentation and / or position determination and / or structure detection:

[0065] - positioning information (the pose of the instrument, the shape of the instrument (e.g. along the centre line of the instrument and / or a functional approximation of the shape of the instrument) and the position of the distal and proximal ends of the instrument (if visible),

[0066] - the entry point of the instrument into the examination object and the parts of the instrument located inside and outside the examination object (if the proximal part of the instrument located outside the examination object is not or not completely included in the image data, the direction to the proximal end can be extrapolated under the assumption that the instrument is in a force-free, i.e. non-actively deflected posture, for which purpose the characteristic data can also appropriately include other information about the medical instrument, in particular the length, etc.).

[0067] Preferably anatomical information, in particular including the current posture of anatomical structures, such as organs and their organ boundaries, in particular including the target region. Furthermore, the elasticity and / or mobility of the anatomical structures can be known or assumed.

[0068] In particular, in the case of a registration with the previous image data from which planning was carried out, the pose of the originally planned instrument trajectory (planning trajectory) can also be tracked in the image data.

[0069] Based on the available information, simulations and / or model calculations can thus be performed to determine how a position correction at the rear (proximal) end of the instrument, including the bending of the instrument, will affect the posture and shape of the instrument in the patient's body and the trajectory of the front (distal) end of the instrument (during further advancement). Characteristic data describing the bendability of the medical instrument (especially in the proximal and distal parts) are also taken into account. The characteristic data include mechanical and / or elastic parameters of the instrument. As mentioned above, for anatomical structures, the mechanical properties can also be known or assumed.

[0070] In this context, it can be expedient to provide that the evaluation unit is designed to determine the characteristic data from the provided device information. The device information can describe, for example, the model and / or type and / or class of the device. For example, the characteristic data can be assigned to the device information in a database and / or a lookup table (LUT). However, it is also conceivable in principle to implement standard assumptions for the characteristic data.

[0071] Preferably, it can be provided that, in addition to the at least one continuation trajectory, the evaluation unit is also designed to determine a future trajectory that would occur without a position correction, and the output unit is designed to display the future trajectory in a diagram. In this way, the user also receives information about how the instrument path would have developed without carrying out a position correction. The continuation trajectory can be compared particularly intuitively and conveniently with the future trajectory and evaluated with regard to the reaching of the target region.

[0072] Furthermore, it is expedient that the evaluation unit is designed to determine a suggestion for an advancement path and the output unit is designed to output the suggestion. For example, the reliability of the precalculation of the continuation trajectory can be determined, wherein an advancement can be recommended up to a certain threshold value of the precalculation reliability. After advancing the suggested advancement distance (which can be in centimeters, for example), a new image data acquisition can be carried out, and thus a new control scan can be carried out, and a new continuation trajectory can be determined for position correction.

[0073] In addition to the interventional device, the invention also relates to a computer-implemented method for determining and outputting positioning instructions for an elongated medical instrument, which can be partially introduced into an intervention area of ​​an examination object for the purpose of intervention, the medical instrument having a proximal end portion which needs to be arranged outside the examination object for manual operation of the medical instrument and is at least partially bendable, wherein an orientation element arranged on the instrument and / or integrated in the instrument is used, the orientation element having a projection surface with at least one marking, the marking marking at least one point, wherein the method, when the instrument has already been partially introduced into the examination object, comprises the following steps:

[0074] - providing image data of the examination object via an interface of the processing device, said image data representing the intervention region, and determining positioning data describing the current position and attitude of the medical instrument,

[0075] - determining at least one predictive, in particular non-linear, continuation trajectory from the image data and the positioning data by means of an evaluation unit of the processing device, using the characteristic data describing the flexibility of the medical instrument,

[0076] - outputting a representation of the intervention region and of the at least one continuation trajectory based on the image data on a presentation device by means of an output unit of the processing device; and

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

[0078] All statements relating to the interventional device according to the invention can be transferred analogously to the method according to the invention, which can also be referred to as a prompting method, and vice versa, so that the advantages already mentioned can be achieved. In particular, the localization data are preferably determined by the evaluation unit using the image data. The method can also include a step of recording the image data, which step is controlled by the recording unit.

[0079] Positioning instructions are to be understood here as workflow instructions, thus forming a support or decision-making aid for the user, which is provided after the positioning of the medical device, in particular within the scope of a control scan that provides image data. It should therefore be pointed out that even if used within the scope of an intervention on a patient, within the scope of the instruction method according to the invention, no guidance, advancement or other manipulation of the medical device in the examination object is performed.

[0080] As already described above for the interventional device, two basic, alternative embodiments are also conceivable for the method. On the one hand, the light pattern can mark a projection point, which needs to be coordinated with the marking assigned to the selected continuation trajectory in order to select the selected continuation trajectory, wherein a diagram is generated with marking information, which is assigned to at least one continuation trajectory and describes the assigned marking. On the other hand, it can be provided that the orientation element has only one marking that defines the orientation point, and the processing device controls the light guide device in order to mark the projection point assigned to the continuation trajectory on the projection surface, wherein the projection point needs to be coordinated with the orientation point in order to select the assigned continuation trajectory.

[0081] The indication method according to the invention can be integrated into a method for treating and / or examining an examination subject by means of an elongated medical instrument, which can be partially introduced into an intervention area of ​​the examination subject for the purpose of intervention, the medical instrument having a proximal end portion which needs to be arranged outside the examination subject for manual operation of the medical instrument and which is at least partially bendable, wherein, in order to determine and output a positioning indication after the instrument has been introduced into the examination subject,

[0082] - using an orientation element arranged on the instrument and / or integrated in the instrument, the orientation element having a projection surface with at least one marking which marks at least one point,

[0083] - providing image data of the examination object via an interface of the processing device, said image data representing the intervention region, and determining positioning data describing the current position and attitude of the medical instrument,

[0084] - determining at least one predictive, in particular non-linear, continuation trajectory from the image data and the positioning data by means of an evaluation unit of the processing device, using the characteristic data describing the flexibility of the medical instrument,

[0085] - outputting a representation of the intervention region and of the at least one continuation trajectory based on the image data on a presentation device by means of an output unit of the processing device; and

[0086] - operating the light guide device for projecting at least one light pattern onto the projection surface, in particular by means of a control unit of the processing device, in such a way that, by observing at least one of the at least one marking and the light pattern as a whole, a positioning instruction for manual position correction on the proximal end portion of the medical instrument is generated in order to achieve a continuation trajectory to be selected from the at least one continuation trajectory during further advancement of the medical instrument,

[0087] After this, the proximal part of the instrument, in particular at the point of action, is manually positioned by the person carrying out the intervention and the instrument is pushed further into the examination subject.

[0088] The method can preferably be carried out iteratively, ie after the instrument has been advanced by a certain, in particular recommended, advancement distance, new image data are recorded / provided and on this basis further positioning instructions are generated and output using the instruction method.

[0089] The computer program according to the invention can be directly loaded into a storage device of a processing device of an interventional apparatus and has program means which, when the computer program is executed, cause the processing device to carry out the steps of the prompting method according to the invention. The computer program can be stored on an electronically readable data carrier, which thus comprises control information stored thereon, which comprises at least one computer program according to the invention and is designed to configure the processing device to carry out the prompting method according to the invention when the data carrier is used in the processing device of an interventional apparatus. BRIEF DESCRIPTION OF THE DRAWINGS

[0090] Further advantages and details of the present invention are apparent from the following description of the exemplary embodiments and from the accompanying drawings.

[0091] In the figure:

[0092] Figure 1 A flow chart showing a general embodiment of a method according to the present invention;

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

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

[0095] Figure 4 A detailed schematic diagram showing a medical device for use in a first embodiment of the present invention;

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

[0097] Figure 6 The directional element for the first embodiment is shown;

[0098] Figure 7 A view showing the prompt in a first state of the instrument and the orientation element;

[0099] Figure 8 A view showing the first state on the projection surface;

[0100] Fig. 9 A view showing the prompt in a second state of the instrument and the orientation element;

[0101] Fig.10 showing a view of the second state on the projection surface;

[0102] Fig.11 A view showing the prompt in a third state of the instrument and the orientation element;

[0103] Fig.12 A view showing the third state on the projection surface;

[0104] Fig.13 A diagram for output on a presentation device related to the first embodiment is shown;

[0105] Fig.14 An orientation element for a second example of the first embodiment is shown;

[0106] Fig.15 A view showing the prompt in a first state of the instrument and the orientation element;

[0107] Fig.16 A view showing the first state on the projection surface;

[0108] Fig.17 A view showing the prompt in a second state of the instrument and the orientation element;

[0109] Fig.18 showing a view of the second state on the projection surface;

[0110] Fig.19 A view showing the prompt in a third state of the instrument and the orientation element;

[0111] Fig. 20 A view showing the third state on the projection surface;

[0112] Fig.21 A third example of an orientation element for use with the first embodiment is shown;

[0113] Fig. 22 A second embodiment of the invention is shown for an instrument with an integrated orientation element.

[0114] A schematic diagram of the section; and

[0115] Fig.23 The figures are shown to illustrate an exemplary embodiment of the second specific embodiment. DETAILED DESCRIPTION

[0116] Figure 1 The flow chart shows a general exemplary embodiment for guiding a medical instrument, in this case a needle, to a target area, which comprises the prompting method according to the invention in steps S2 to S7 .

[0117] In step S1, which is performed before the prompting method starts, the medical device is pushed into the object to be examined, for example a patient or an examination phantom. This can be performed according to a pre-planned instrument trajectory, i.e., a planned trajectory, which, as is known in principle, has been planned according to planning image data (which may correspond to the pre-image data mentioned later). Here, the planned trajectory can be set by laser guidance performed by means of a light guide device also used in the prompting method below, and the medical device is then introduced further into the object to be examined by a certain distance according to the planned trajectory. However, since this process and other (intentional or unintentional) movement processes in the intervention area where the instrument target (target area) is also present may lead to changes, it is not necessarily possible to reach the target area via the planned trajectory.

[0118] However, the method presented here does not necessarily require planning, which means that a user, for example a doctor, can initially advance the medical instrument a first distance without guidance or under real-time imaging and nevertheless reliably reach the target area based on the subsequent guidance method.

[0119] In the first step of the prompting method according to the invention, step S2, image data of the intervention area of ​​the instrument are recorded as a control scan by an imaging device controlled by a recording unit of a processing device of the interventional apparatus that performs the intervention, with the medical instrument already partially introduced into the object under examination. This can be a three-dimensional recording, for example a computed tomography scan, but it is also conceivable 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 (in particular fluoroscopic images) from different projection directions (angles), i.e. with different recording geometries. If necessary, the recording can also include the reconstruction of images, for example axial slice images that map the intervention area in a computed tomography scan.

[0120] If there are prior image data, in particular three-dimensional, of the intervention region, whose image information is useful for the subsequent analysis, the image data can also be rigidly or preferably elastically registered with the prior image data, for example a planning image data set. In the case of elastic registration, the registration transformation already contains information about possible deformations of the anatomical structures in the intervention region; in the case of rigid registration, only simple translational movements can be inferred.

[0121] Then, in step S3, the image data is analyzed in an analysis unit of the processing device using conventional analysis methods, in particular together with the pre-image data registered therewith. For example, segmentation algorithms, position determination algorithms, classification algorithms, detection algorithms, etc. may be used.

[0122] Within the scope of the analysis, firstly positioning information about the at least partially elastically bendable elongated medical instrument is determined. The positioning information may include, for example

[0123] - The posture of medical devices,

[0124] - the shape of the (in this case with a certain flexibility) medical device (e.g. as a centre line and / or as a functional description of the shape),

[0125] - the position of the distal end and the proximal end of the instrument, wherein, if the proximal part of the instrument located outside the examination object is not visible or is only partially visible in the image data, the proximal end can still be estimated based on known characteristics of the instrument, in particular its length, assuming that no forces are applied, and / or

[0126] The insertion point (entry point) at which the medical device is introduced into the body of the examination subject and the part of the medical device located inside the examination subject (distal part) and outside the examination subject (proximal part).

[0127] In step S3, anatomical information can also be determined by analyzing the image data, in particular the posture of the target area (instrument target), the posture of the anatomical structure and / or the boundaries of an organic structure (such as an organ) and / or the posture of the planned trajectory (if any) in the anatomical structure.

[0128] The determination of the anatomical information can be performed at least partially taking into account the registered prior image data, in particular if the anatomical structures have been segmented and / or marked in the prior image data.

[0129] Then in step S4, simulation and / or model calculation is performed to determine how the position correction including the bending of the instrument at the proximal part of the instrument, especially at the proximal end of the instrument, affects the posture and shape of the instrument in the object of examination, i.e., the distal part. In particular, what kind of trajectory may be generated as a continuation trajectory in the presence of position correction and advancement of the medical instrument is pre-calculated. In addition to these position corrections and the assigned continuation trajectories, the future trajectory of the medical instrument formed without position correction is also pre-calculated, and the future trajectory is formed when the medical instrument is advanced without position correction at the proximal end. All these calculations are performed under the consideration of the bendability of the medical instrument, and therefore the characteristic data describing the elastic bendability of the medical instrument. These characteristic data may include, for example, mechanical parameters and / or elastic parameters. The characteristic data can be based on standard assumptions, and preferably, the characteristic data is retrieved, for example, from a database and / or a lookup table, based on the instrument information provided, for example, inferred from user input. For example, the instrument information can describe the model and / or type and / or type of the medical instrument.

[0130] Which position corrections are to be made and in what manner the at least one continuation trajectory is determined depends on which specific method is selected. If an orientation element with a projection surface is provided on the medical device, on which a plurality of different markings describing position corrections known in the evaluation unit are provided, then a continuation trajectory can be determined for all of these markings and the associated position corrections. However, if a specific position correction is suggested on the projection surface, for example by a light pattern of a light guide device that can be controlled by a control unit, then the position correction can also be determined in such a way, for example in an optimization method, that the target area is reached as accurately as possible.

[0131] Finally, for each continuation trajectory individually or for all continuation trajectories as a whole, a proposed advancement distance to the next control scan can be determined in step S4, for example based on a reliability value indicating a precalculated reliability for the continuation trajectory or trajectories at this distance.

[0132] Furthermore, in all these analyses, the attitude of the point of action for performing the position correction on the proximal part of the instrument is also taken into account. The attitude of the point of action at the proximal end of the medical instrument is preferred here. Depending on the attitude of the point of action, the proximal part may have other shapes, in particular curvatures, which are taken into account accordingly.

[0133] In step S5, an illustration is generated by an output unit of the processing device and output by a presentation device, such as a monitor, which can be well 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 (an image plane as the image data in the illustration). The illustration also displays the medical devices and anatomical structures in the intervention area through the image data, wherein, for better recognizability, the medical devices and anatomical structures can be emphasized and / or contrasted, especially when the medical devices 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, graphic elements by superimposition, which gradually display at least one continuation trajectory and future trajectory with precise position. If a recommended advancement distance is determined, the advancement distance can also be output. The following will be discussed in more detail with respect to different embodiments.

[0134] In optional step S6, at least one continuation trajectory can be selected based on user input. This is particularly useful if a plurality of continuation trajectories have already been determined and no selection possibility is provided by identifying suitable markings or distinguishable suitable projection points, which will be discussed below. In particular, the selection can be achieved by evaluating the continuation trajectories in the diagram.

[0135] Finally, in step S7, a positioning prompt is output for setting a corresponding manual position correction on the proximal part of the medical instrument so that when the medical instrument is pushed further in, the continuation trajectory to be selected from the at least one continuation trajectory is reached, wherein the positioning prompt is formed by an overall observation of the light pattern emitted by the light guide device on the projection surface, at least one mark on the projection surface and, if necessary, a graphic representation. 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 Elaborate in detail.

[0136] The prompting method thus ends, and in a step following the prompting method, the person performing the intervention, i.e. the user, can perform a position correction following the positioning prompts, thereby establishing the conditions for the selected continuation trajectory, and then advance the medical device further in the direction of the device target by manual advancement, for example by the recommended advancement distance.

[0137] Then, in step S9, it is checked whether the instrument target, in particular the target area, has been reached and can be continued with the interventional reason, so that the actual interventional reason can be executed in step S10. Otherwise, the prompting method including a new control scan, i.e. steps S2 to S7, is executed again in order to help the user reach the instrument target. It should be noted that the control scan can of course also have been executed as the 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 first comprises a medical device 2, to which a directional element 3 is fixed or integrated. The medical device 2 is designed as a needle 4. The imaging device 5 is a computer tomography device with a gantry 6, on which a light guide device 7 is arranged. The light guide device 7 can have one or more laser light sources for generating a laser fan and / or a laser beam in order to form a light pattern when aligned accordingly with the projection surface.

[0139] The object to be examined can be moved into the gantry 6 via the patient couch 8 .

[0140] The presentation device 9 is designed here as a monitor 10 .

[0141] The operation of the interventional device 1, in particular for executing the prompting method, is controlled by a processing device 11, the functional structure of which is described in Figure 3 . In addition to the storage device 12, the processing device 11 first includes a recording unit 13 for controlling the imaging device 5 to record image data and, if necessary, to align the image data with previous image data and / or for reconstructing volume and / or layer images, in particular 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 continuation trajectory and, if necessary, the future trajectory and the recommended advancement distance according to steps S3 and S4. The output unit 15 is designed to generate and output a diagram according to step S5, and the control unit 16 is used to control the light guide device 7, in particular within the scope of step S7. Of course, other functional units or sub-functional units can also be considered.

[0142] Figure 4 The schematic diagram shows a view of an instrument 2, on which an orientation element 3 is mounted, here at the proximal end. The orientation element 3 forms a projection surface 17 on its upper side. If the dashed line 18 is used as the boundary of the examination object 19, the medical instrument 2, which here has an elastically bendable elongated instrument shaft 20 as a needle 4, has a proximal part 21 and a distal part 22 with a distal end 23, which is to reach the instrument target, i.e. the target area.

[0143] Figure 5A possible design of the light guide device 7 on the gantry 6 is shown by way of example. Here, the light guide device 7 has a laser light source for generating two laser fans 24 and 25, wherein, for example, the laser fan 24 can display the attitude or orientation of the reconstructed axial layer on the examination object in the form of orientation lines at least in 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. Actuators can be assigned to the laser light source in order to adjust the laser fans 24 and 25; the relative position can also be adjusted by controlling the patient couch 8 by means of the control unit 16.

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

[0145] A first embodiment, for which some examples will now be explained, provides that the light pattern marks projection points which, in order to select a selected continuation trajectory, need to be brought into harmony with the markings assigned to the selected continuation trajectory. For this purpose, the output unit 15 is designed to generate a representation with marking information which is assigned to at least one continuation trajectory and describes the assigned markings. In the exemplary embodiment of the first embodiment shown below, work is expediently performed within the layers of an axial slice image which also forms the basis for the representation.

[0146] Figure 6 For the first exemplary embodiment, a possible design of the projection surface 17 of the orientation element 3 is shown. The projection surface has a marking in the form of a crosshair, wherein the crosshair is formed by two orientation lines 26 extending perpendicularly to each other. Concentric circles or rings 27, 28 and 29 extend around the center of the cross, which are applied in 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 the orientation line 26 several times.

[0147] Figures 7 to 12 Describes how to use directional element 3 to output positioning cues, where: Fig.13A possible illustration 31 on the presentation device 9 is shown. It can be seen here that the illustration 31 is based on image data 32, in which the anatomical structure and the medical instrument 2 are partially visible. The central graphic element 33 shows the future trajectory, and the graphic elements 34, 35, 36 adjacent to it in two directions show the continuation trajectory. In this case, the graphic element 33 remains in a color that does not appear in the circles 27, 28 and 29, for example orange, while the distinguishable optical properties of the graphic elements 34, 35 and 36 correspond to the distinguishable optical properties of the circles 27, 28 and 29, respectively. In other words, the graphic element 34 is green, the graphic element 35 is blue and the graphic element 36 is purple. Therefore, the graphic elements 34, 35 and 36 not only show the course of the continuation trajectory, but also contain marking information (color) in order to assign to the corresponding marking on the projection surface 17 of the orientation element 3.

[0148] This allows for an unambiguous assignment (or one-to-one correspondence) of the markings with respect to the direction in which the respective continuation trajectory deviates from the future trajectory while remaining within the slice of the axial slice image.

[0149] Figure 7 and Figure 8 The first case is now shown, in which the light pattern (see Figure 8 , here formed by orientation lines 37 and projection lines 38 perpendicular thereto) also form a cross, but does not coincide with the cross of the orientation lines 26 of the crosshairs. The orientation lines 37 indicate the presentation orientation, i.e. the orientation of the image plane of the axial slice image, and can be easily recognized by the user based on the arrangement of the imaging device 5 and the examination object 19 on the patient couch 8. By operating the light guide device 7 and / or the patient couch 8, the direction of the cross beam 39 (see Figure 7 ) is at least consistent with the longitudinal direction of at least the proximal part 21 of the instrument 2, so that the intersection point of the representative projection point 40 of the light pattern composed of the orientation line 37 and the projection line 38 corresponds to the intersection point of the orientation line 26.

[0150] If through Fig. 9 and Fig.10 As shown, the user now rotates the orientation element 3 so that (see Fig.10 ) One of the orientation lines 26 lies on the orientation line 37, wherein the other orientation line 26 lies on the projection line 38. The intersection points of the circles 27, 28 and 29 with the orientation line 37 or the corresponding orientation line 26 now mark the target points in such a way that when the projection point 40 coincides with the corresponding target point, a position correction is established which results in a correspondingly color-coded continuation trajectory in the corresponding direction.

[0151] This is because the continuation trajectory is determined precisely from these position corrections given by the target points in the slice. Since the position of the markings, specifically the circles 27, 28 and 29 here, is known, the position corrections formed in the slice are also known and the corresponding continuation trajectory can be determined in step S4, of course taking into account the points of action. Here, the user can intuitively clearly and unambiguously understand the corresponding directions and their effects, as well as which of the lines 37, 38 is the orientation line 37, because the object under examination 19 is accordingly in front of him and the illustration also relates to this slice.

[0152] As in Fig.11 and Fig.12 As shown in FIG. 1 , in the first embodiment, the user selects the continuation trajectory according to the lower graphical element 35 (blue), because this continuation trajectory is closest to the target area, and thus a position correction is performed at the point of action at the proximal end of the instrument 2 so that the projection point 40 is as shown in FIG. Fig.12 It is shown at the left intersection of the blue circle 28 and the orientation line 26, which already coincides with the position line 37. If it is now advanced, the adjustment will form a continuation of the trajectory shown by the lower graphical element 35. In this case, the medical instrument 2 remains in the axial layer, which is represented by the slice image of the image data 32, which is the basis of the illustration 31, so that no changes are required for the further control scan and for the position line 37.

[0153] In particular, if, as shown, work is to be carried out in fixedly predefined layers, it is also possible to use the projection surface 17 of the orientation element 3 as for Fig.14 Here, the projection plane 17 is maintained in the direction of the (here only one) orientation line 26, and the circles 27, 28, 29 are reduced to lines 41 (green), 42 (blue) and 43 (purple) perpendicular to the orientation line 26.

[0154] In the second embodiment, the adjustment possibilities for the second laser fan 25 or the patient couch 8 are not sufficient, for example, to meaningfully position the projection point 40 in the center of the projection surface 17, so that, in addition to continuing to display the orientation line 37 presenting the orientation, i.e., the orientation of the axial layer, the light guide device projects the orientation point 45 onto the projection surface 17 via a laser light source for outputting a laser beam 44 to form a light pattern and define the projection point 40. The laser beam 44 and the laser fan 24 can have different colors.

[0155] Fig.15 and Fig.16 The original state (first case) is shown again, in which the orientation line 37 and the orientation line 26 do not coincide, but the projection point 40 is already located at the central intersection of the markings. Fig.17 and Fig.18In the second case, the orientation element 3 is rotated so that the orientation line 37 and the orientation line 26 overlap. The intersection points of the lines 41, 42 and 43 with the orientation line 26 are now Fig. 9 and Fig.10 The same applies to the target points to which the projection point 40 needs to be moved in order to select the continuation trajectory, which is respectively displayed as a graphical element 34 , 35 or 36 in the diagram 31 .

[0156] In accordance with Fig.19 and Fig. 20 In the third case, the continuation trajectory assigned to (or associated with) the lower graphical element 35 is again selected by a corresponding position correction, since the projection point 40 is now located at the target point defined by the left-hand line 42 (blue).

[0157] Fig.21 A third example of the first embodiment is shown, in which, in addition to the cross formed by the orientation line 26 and the further line 46, points 47 are provided as markers for the matrix-shaped arrangement of the coordinate grid with corresponding names. For example, the coordinates of the respective point 47 as a target point can be assigned to the graphical elements 34, 35, 36 as marking information in the diagram 31. If, for example, the projection point 40 cannot be arranged at the intersection of the orientation line 26 and the further line 46, a corresponding description is also possible.

[0158] In a second embodiment, it is sufficient to have at least one mark showing an orientation point on the projection surface 17, because the control unit 16 controls the light guide device 7 in such a way as to mark the projection point assigned to the continuation trajectory on the projection surface 17, so that in order to select the assigned continuation trajectory, that is, in order to adjust and form the necessary position correction, it is necessary to coordinate the projection point with the orientation point.

[0159] Since a simpler markup can be considered in this case, Fig. 22 An exemplary embodiment is shown in which the orientation element 3 is integrated into the instrument 2 , namely the proximal end face as projection surface 17 .

[0160] Fig.23 This marking is shown more precisely, which defines an orientation point 48 in the center (corresponding at least to the longitudinal direction of the proximal part 21 without position correction). The projection point 49 as a light pattern or part of a light pattern deviates significantly from the orientation point. If the position of the instrument 2 is now corrected at the point of action so that the orientation point 48 and the projection point 49 coincide, then a position correction is performed to achieve a continuation of the trajectory assigned to the projection point 49 and this can be achieved by advancing.

[0161] In the case of one projection point 49 , the marking information in the illustration 31 can individually emphasize the assigned continuation trajectory, while in the case of a plurality of projection points 49 , the assignment can also be achieved via distinguishable optical properties.

[0162] Especially in the embodiment of the second embodiment in which only one projection point 49 is used, the use of optional step S6 makes sense, so that, for example, the desired continuation trajectory has already been selected in the diagram 31, and then a suitable projection point 49 is obtained by projection to output a positioning prompt.

[0163] In this context, however, it is also possible to automatically determine or select the most suitable continuation trajectory for reaching the instrument target, to display it in the diagram 31 and to project a suitable projection point 49 via the guidance device 7 .

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

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

Claims

1. A medical interventional device (1), comprising: an elongated medical instrument (2) which can be partially introduced into an intervention area of ​​an object to be examined (19) for the purpose of intervention, the medical instrument having a proximal end portion (21) which is to be arranged outside the object to be examined (19) for manual operation of the medical instrument (2) and is at least partially bendable, an orientation element (3) arranged on the instrument (2) and / or integrated in the instrument (2), said orientation element having a projection surface (17) with at least one marking which marks at least one point, - a presentation device (9), - a processing device (11), said processing device comprising: - an analysis unit (14) designed to determine at least one predictive continuation trajectory from image data (32) of the examination object (19) showing the intervention area and positioning data describing the current position and posture of the medical instrument (2), using characteristic data describing the flexibility of the medical instrument (2), and an output unit (15) for outputting a representation (31) of the intervention region and of at least one continuation trajectory based on the image data (32) on a presentation device (9); and - a light-guiding device (7) for projecting at least one light pattern onto a projection surface (17) in such a way that, by observing at least one of the at least one marking and the light pattern as a whole, a positioning prompt for manual position correction on the proximal part (21) of the medical device (2) is formed, so that a continuation trajectory to be selected from the at least one continuation trajectory is realized during further advancement of the medical device (2).

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

3. The interventional device according to claim 1 or 2, characterized in that The light pattern comprises at least one orientation line (37) which indicates the orientation of the representation (31), in particular an image plane of a layer of image data (32) used in the representation (31).

4. The interventional device according to claim 2 or 3, characterized in that In order to mark the projection point (40) on the orientation line (37), the light pattern comprises an orientation point (45) which can be adjusted in a controllable manner, in particular by the processing device (11) based on the positioning information.

5. The interventional device according to claim 3 or 4, characterized in that The marking has at least one orientation line (26) which needs to coincide with an orientation line (37).

6. The interventional device according to claim 5, characterized in that Markings are provided along the orientation lines (26) which can be assigned to the continuation trajectory, so that in the orientation lines (26) coinciding with the orientation lines (37), the medical instrument (2) remains in the layer marked by the orientation lines (37) for each position correction.

7. The interventional device according to claim 5 or 6, characterized in that the marking forms at least a part of a crosshair comprising at least one orientation line (26), the center of which coincides with the projection point (40) before the position correction is performed, and the rings (27, 28, 29) of the crosshair are assigned to the respective continuation tracks, in particular in different colors, and / or The markings form a coordinate grid, in particular a matrix-shaped grid, wherein at least the markings which can be assigned to a continuation trajectory are assigned coordinates.

8. The interventional device according to claim 1, characterized in that The orientation element (3) has only one marking defining an orientation point (48), and the processing device (11) is designed to control the light-guiding device (7) so as to mark a projection point (49) assigned to the continuation trajectory on the projection surface (17), wherein the projection point needs to be coordinated with the orientation point (48) in order to select the assigned continuation trajectory.

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

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

11. The interventional device according to claim 10, characterized in that The light guide device (7) is fixedly mounted on the imaging device (5) and / or integrated in the imaging device.

12. The interventional device according to claim 1, characterized in that The evaluation unit (14) is designed to determine the localization data at least partially from the image data (32) and / or to register the image data (32) with provided previous image data of the examination object (19).

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

14. A computer-implemented method for determining and outputting positioning instructions for an elongated medical instrument (2), which can be partially introduced into an intervention area of ​​an object to be examined (19) for the purpose of intervention, the medical instrument having a proximal end portion (21) to be arranged outside the object to be examined (19) for manual operation of the medical instrument (2) and being at least partially bendable, wherein: An orientation element (3) arranged on and / or integrated in an instrument (2) is used, the orientation element having a projection surface (17) with at least one marking, the marking marking at least one point, wherein the method comprises the following steps when the instrument (2) has already been partially introduced into the examination object (19): - providing image data (32) of the examination object (19) showing the intervention region via an interface of the processing device (11) and determining positioning data which describe the current position and posture of the medical device (2), - determining at least one predictive continuation trajectory from the image data (32) and the positioning data by means of an analysis unit (14) of the processing device (11), using characteristic data describing the flexibility of the medical instrument (2), - outputting a representation (31) of the intervention region and of at least one continuation trajectory based on the image data (32) on a presentation device (9) by means of an output unit (15) of the processing device (11); and - The light-guiding device (7) for projecting at least one light pattern onto the projection surface (17) is operated in such a way that, by observing at least one of the at least one marking and the light pattern as a whole, a positioning prompt for manual position correction on the proximal part (21) of the medical device (2) is formed so as to realize the continuation trajectory to be selected from the at least one continuation trajectory during the further advancement of the medical device (2).

15. A computer program which, when executed on a processing device (11) of an interventional apparatus (1), causes the processing device to execute the steps of the method as claimed in claim 14.

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