Needle guidance device and set including multiple elements

Abstract

The present invention relates to a needle guidance device for guiding and positioning a needle-like device on a patient, the needle guidance device comprising a base element and a needle guidance element on which a needle-like device can be guided along its length, the angular orientation of the needle guidance element being settable in two independent angular degrees of freedom relative to the base element. The needle guidance device has an operating element by means of which the angular orientation of the needle guidance element in the two angular degrees of freedom can be fixed or such fixation can be released again. The needle guidance device also has, for each of the two settable angular degrees of freedom, an angle scale and an angle pointer associated with that angle scale, such that a user can read the currently set angular orientation of the needle guidance element in the two angular degrees of freedom based on the position of the associated angle pointer relative to the associated angle scale.

Description

[Technical Field]

[0001] The present invention relates to a needle guidance device for guiding and positioning a needle-like device on a patient, the needle guidance device comprising a base element and a needle guidance element on which a needle-like device can be guided along its length, the angular orientation of the needle guidance element relative to the base element being adjustable in two mutually independent angular degrees of freedom. The present invention further relates to a set comprising a plurality of elements for performing an examination and / or treatment of a patient. [Background technology]

[0002] In general, the present invention relates to the field of medical devices that can be used for examining and / or treating patients, for example in the context of biopsies or pain treatment. These procedures are usually performed manually using imaging by ultrasound, computed tomography or magnetic resonance imaging. It is already known to assist physicians by using mechanical assistance devices in the form of needle guidance devices that simplify the alignment of a biopsy needle and maintain the alignment during the performance of the biopsy. Such needle guidance devices are known, for example, from International Patent Publication No. WO 2019 / 101862 A1. Summary of the Invention [Problem to be solved by the invention]

[0003] The present invention is based on the object of showing further improved aids for the examination and / or treatment of patients when using needle-like devices. [Means for solving the problem]

[0004] This object is achieved by a needle guidance device for guiding and positioning a needle-like device on a patient, the needle guidance device having a base element and a needle guidance element over which the needle-like device can be guided along its length, the angular orientation of the needle guidance element relative to the base element being adjustable in two mutually independent angular degrees of freedom; a) the needle guidance device has an operating element by means of which the angular orientation of the needle guidance element can be fixed in two angular degrees of freedom or such fixing can be released again, b) the needle guidance device is characterized in that it has an angle scale for each of the two adjustable angular degrees of freedom and an angle indicator associated with each angle scale such that the currently set angular orientation of the needle guidance element in the two angular degrees of freedom is readable by the user based on the position of the respective angle indicator in relation to the associated angle scale.

[0005] The needle guidance device according to the present invention significantly simplifies the examination and / or treatment of patients with needle-like devices, for example during biopsies. The angular orientation of the needle guidance element can be fixed and released again in two angular degrees of freedom by a single operating element. In this way, the needle guidance device is suitable for one-handed operation, at least with respect to the actuation of the operating element. Furthermore, the use of the needle guidance device is simplified by the presence of a respective angle scale and associated angle indicator for each of the two adjustable angular degrees of freedom. In this way, the user can make the required angle adjustments quickly and without additional equipment by observing the angle indicator and angle scale.

[0006] The needle guidance device can be advantageously designed so that, depending on the respective settings of the angular orientation of the needle guidance element in the two angular degrees of freedom, the needle-like device guided by the needle guidance element always contacts the same position on the patient's body, i.e., in the case of a biopsy, the biopsy needle always hits the same puncture point. The base element here serves to fix the needle guidance device to the patient's body, for example by means of a releasable adhesive. The needle-like device can be, for example, a biopsy needle, an injection needle, or an ablation needle.

[0007] According to an advantageous embodiment of the present invention, the needle guidance device has a clamping mechanism operable by an operating element, such that the angular orientation of the needle guidance element relative to the base element in two angular degrees of freedom can be fixed by clamping by operating the clamping mechanism using the operating element. Such a clamping mechanism can be realized in a relatively simple manner, for example, using screw-type elements that can be tightened relative to each other, thereby fixing parts of the needle guidance device and thereby fixing the angular orientation of the needle guidance element by clamping. The clamping mechanism specifically allows for stepless adjustment of the angular orientation of the needle guidance element relative to the base element in two angular degrees of freedom. In this way, latching operations can be avoided, so that essentially any desired angular orientation can be set within the possible pivot range of the needle guidance element. The angular orientation of the needle guidance element can also be adjusted in a stepped manner in at least one or both angular degrees of freedom, for example, via a latching element.

[0008] According to an advantageous embodiment of the invention, the angular orientation of the needle guidance element relative to the base element is steplessly adjustable in two angular degrees of freedom, so that virtually any setting of the angular orientation is possible in both angular degrees of freedom, so that the user is not limited by the design of the needle guidance device with regard to adjustability.

[0009] According to an advantageous embodiment of the present invention, the needle guidance device has a retaining bracket to which the needle guidance element is fixed, the retaining bracket being movable relative to the base element in a first of two angular degrees of freedom, and the needle guidance element being movable relative to the retaining bracket in a second of two angular degrees of freedom. This allows for a simple and robust construction of the needle guidance device. The retaining bracket can be formed, for example, in an arched shape, which can accommodate the arcuate mobility of the needle guidance element relative to the retaining bracket. The needle guidance element can be guided, for example, in a carriage-like manner or using a retaining carriage on the retaining bracket, and can be moved along the retaining bracket with an arcuate movement corresponding to the arched shape of the retaining bracket, and thus can be moved relative to the retaining bracket. The retaining bracket can be fixed to the base element, for example, so as to be pivotable about a pivot axis.

[0010] According to an advantageous embodiment of the present invention, the needle guidance device has a clamping bracket fixed to the base element and pivotable relative to the base element around the same pivot axis as the retaining bracket. The clamping bracket can form part of the clamping mechanism described above. For example, the clamping bracket can be coupled to the retaining bracket so that when the retaining bracket moves relative to the base element, the clamping bracket also moves in the same way, for example the pivoting movement described above. The clamping bracket can be arranged, for example, between the retaining bracket and the base element. The clamping bracket can be arched, for example, with an arch shape concentric with the arch shape of the retaining bracket.

[0011] The holding bracket and the clamping bracket can be, for example, at least substantially parallel to each other, i.e., can form two arches extending substantially parallel to each other. There can be a certain distance or free space between the holding bracket and the clamping bracket. Due to at least the arch shape of the clamping bracket, the needle guidance device has a free space in the area between the clamping bracket and the base element, which free space can be, for example, substantially circular or hemispherical in shape relative to the swivelability of the clamping bracket. The clamping bracket can be pivotally coupled to the holding bracket so that the clamping bracket can always be pivoted by the same angle as the holding bracket.

[0012] When the operating element is used to fix the needle guide element in two angular degrees of freedom, the holding bracket and the clamping bracket can press against each other, thereby using the free space between them. The holding bracket and / or the clamping bracket can be slightly deformed in the process. Clamping on the base element can occur, for example, in the arched region of the base element to which the holding bracket and / or the clamping bracket are pivotally attached. In this way, actuation of one operating element can produce a kind of "remote clamping," i.e., a clamping action at a point remote from the operating element can also be triggered.

[0013] As mentioned above, the needle guidance device can be designed so that, depending on the respective settings of the angular orientation of the needle guidance element in the two angular degrees of freedom, the needle-like device guided through the needle guidance element always contacts the same position on the patient's body, i.e., in the case of a biopsy, the biopsy needle always hits the same puncture point. The base element can have a fixation surface on its side facing the patient, which is used to fix the base element to the patient. For this purpose, the needle guidance device can be designed so that both the pivot axis of the holding bracket relative to the base element (X-axis) and the pivot axis of the needle guidance element relative to the base element, which is defined by the arch shape of the holding bracket (Y-axis), pass strictly within the plane of the fixation surface.

[0014] According to an advantageous embodiment of the present invention, the first angle scale is arranged on the holding bracket and / or the clamping bracket, and / or the second angle scale is arranged in the area of ​​the fixing mechanism of the holding bracket on the base element. This has the advantage that the relatively large existing surfaces of these components (holding bracket, clamping bracket, and base element) can be used to mark the respective angle scales. In this way, the angle scales are easier to read. A first angle indicator associated with the first angle scale can be arranged, for example, on the needle guide element or on a component connected to the needle guide element, such as the aforementioned holding carriage. A second angle indicator associated with the second angle scale can be arranged, for example, on the holding bracket and / or the clamping bracket.

[0015] Advantageously, the aforementioned association of the first angle scale with the holding bracket and / or clamping bracket with the associated angle indicator can also be varied. In other words, the first angle indicator can also be arranged on the holding bracket and / or clamping bracket. In this case, for example, the first angle scale associated with the first angle indicator can be arranged on the needle guide element or on a component coupled to the needle guide element. This also applies to the second angle scale. Therefore, as an alternative, the second angle indicator can be arranged on the base element in the region of the fixing mechanism of the holding bracket. In this case, for example, the second angle scale associated with the second angle indicator can be arranged on the holding bracket and / or clamping bracket.

[0016] According to an advantageous embodiment of the invention, the needle guidance device has a needle guidance element receiving portion that is designed to receive needle guidance elements of different designs of the needle guidance device. This has the advantage that the needle guidance device can be used in a very versatile manner for various examinations and / or treatments of patients. For example, by exchanging the needle guidance element, the needle guidance device can be adapted to needle-shaped devices with different diameters.

[0017] According to an advantageous embodiment of the present invention, the needle guide element receiving portion extends from the holding bracket to the clamping bracket. In this way, the holding bracket can be coupled to the clamping bracket via the needle guide element receiving portion. Therefore, since the needle guide element receiving portion can perform several functions, namely, receiving needle guide elements of different designs and coupling the holding bracket to the clamping bracket, the entire needle guidance device can be realized with very few components. Furthermore, further parts of the clamping mechanism, such as a screw portion, can be arranged on the needle guide element receiving portion.

[0018] According to an advantageous embodiment of the present invention, the operating element is designed as an annular operating element having an internal cavity through which at least a portion of the needle guide element extends. The operating element can be designed, for example, in the form of a nut with an internal thread. The internal thread can be a thread that matches the thread of the needle guide element receiver so that the operating element can be screwed onto the needle guide element receiver in the form of a nut. This threaded connection between the operating element and the needle guide element receiver allows a clamping mechanism to be activated by tightening the threaded connection to obtain a clamping force, for example, to fix the needle guide element relative to the base element in two angular degrees of freedom. This also allows for a particularly compact design of the needle guidance device.

[0019] According to an advantageous embodiment of the present invention, the base element has a bearing surface that rests on the patient's body. The bearing surface can have, for example, a narrow, elongated rectangular shape, optionally with rounded corners. In this way, the needle guidance device requires only a small amount of space for the bearing surface on the patient's body, making it highly versatile and usable, for example, even for small patients. The bearing surface can be designed as a flat surface.

[0020] The object stated at the beginning is further achieved by a set comprising a plurality of elements for carrying out examination and / or treatment of a patient, said set comprising: a) a needle guidance device for guiding and positioning a needle-like device on a patient, the needle guidance device having a base element and a needle guidance element on which the needle-like device can be guided along its length, the angular orientation of the needle guidance element relative to the base element being adjustable in at least one angular degree of freedom or in several mutually independent angular degrees of freedom, for example two or three mutually independent angular degrees of freedom; b) a computer with a computer program or at least one such computer program for a computer, the computer program being such that, when the computer program is run on the computer, b1) positioning designations for positioning the needle guidance device (1) on the patient, and / or b2) one or more angular orientation values ​​for setting the angular orientation of the needle guidance element relative to the base element in at least one angular degree of freedom or in several mutually independent angular degrees of freedom; To calculate and output these values ​​to the user, - characteristic data of the needle guidance device; - Patient test data; - at least one predetermined examination and / or treatment step performed using the needle guidance device.

[0021] In summary, the set includes at least two elements, namely, a needle guidance device and a computer with a computer program or the computer program itself, which can be stored on a data carrier. The set can also include one or more additional elements, such as orientation aids, as described below.

[0022] Such a set may assist a physician in carrying out various steps of the examination and / or treatment, for example in the case of a biopsy. In particular, the process sequence may be assisted by a computer program or by the use of a computer program or computer that outputs corresponding instruction steps for each method step to be performed.

[0023] The computer is configured to execute a computer program, e.g., in the sense of software. The computer can be designed as a commercially available computer, e.g., a PC, laptop, notebook, tablet or smartphone, or as a microprocessor, microcontroller or FPGA, or as a combination of such elements.

[0024] Advantageously, the computer or computer program specifically assists the user when positioning the needle guidance device on the patient and / or when setting the angular orientation of the needle guidance element relative to the base element in at least one angular degree of freedom or in several independent angular degrees of freedom. In other words, the computer program can make it significantly easier for the user to correctly position and adjust the needle guidance device.

[0025] The computer program requires as input at least characteristic data of the needle guidance device, such as specified values ​​for the geometry of the angle adjustment mechanism and the placement of the reference point of the base element. The characteristic data of the needle guidance device can, for example, be pre-stored in the computer, and when different needle guidance devices are used, the characteristic data of the different needle guidance devices can be stored in the computer and options can be displayed for the user so that the user can select the particular needle guidance device to use by entering it on the computer.

[0026] The computer program requires as input patient examination data and at least one predetermined examination and / or treatment step to be performed using the needle guidance device. The patient examination data can be data from an imaging examination of the patient, for example, from an X-ray, MRT, and / or ultrasound examination. The X-ray examination can be, for example, a CT examination. For example, image data obtained from the examination, or a DICOM file, can be directly provided to the computer for processing using the computer program. The specified values ​​for the examination or treatment step to be performed can be, for example, user-defined coordinates of the puncture point of the needle-like device on the patient and the target point in the body.

[0027] The input data may be provided to the computer via a wireless or wired interface and / or by manual entry.

[0028] The computer program can then generate the aforementioned positioning and / or angular orientation specifications as output. For example, the two-dimensional coordinates of at least two reference points in a patient-related coordinate system, which may be located, for example, on a base element of the needle guidance device, are output as positioning specifications. For the angular orientation specifications, two angular specifications, for example in degrees, based on a 360-degree system can be output. The user can then use these positioning and / or angular orientation specifications to position the needle guidance device at a desired location and position on the body and adjust the angular orientation of the needle guidance element in two angular degrees of freedom before or after this positioning. The needle guidance device included in the set can be, for example, a needle guidance device of the type described in the introduction, i.e., a needle guidance device according to the present invention, or another type of needle guidance device, for example, a known needle guidance device. For example, a needle guidance device according to International Patent Publication No. WO 2019 / 101862 A1 can also be used.

[0029] According to an advantageous embodiment of the invention, the set further comprises an orientation aid on which marks defining a two-dimensional coordinate grid are arranged, the orientation aid having a fixation surface configured to fix the orientation aid to the patient. Such an orientation aid makes the mapping of the patient-related coordinate system to the coordinate system used by the computer program safer and simpler. In particular, such mapping is simplified for the user, since only the orientation aid needs to be applied to the patient, and corresponding characteristic data of the patient-related coordinate system can be made available to the computer and the computer program by automatic detection of the orientation aid on the patient, for example using a camera and image evaluation.

[0030] The orientation aid can, for example, consist of several strips arranged at right angles to one another and joined together to form a grid. The individual strips can be provided with marks or graduations that can be read by the user and facilitate optical recognition of the desired coordinate positions on the patient. The orientation aid can also have a substantially closed surface, similar to a sheet of paper or large plaster on which a two-dimensional coordinate grid has been printed, for example.

[0031] The coordinate grid can be printed or otherwise attached to the orientation aid, for example. The coordinate grid can be designed in a Cartesian coordinate system and can have, for example, a horizontal coordinate (X coordinate) and a vertical coordinate (Y coordinate). The coordinate axes can be graduated, for example, with numbers and / or letters.

[0032] According to an advantageous embodiment of the invention, the orientation aid is provided to be designed as a flat flexible element, which has the advantage that the orientation aid can also be easily applied to curved areas and ridges of the patient's body.

[0033] According to an advantageous embodiment of the present invention, the patient's examination data includes position information relative to an orientation aid fixed to the patient, and the computer program is further configured to calculate the output positioning and / or angular orientation specifications as a function of the position information relative to the orientation aid on the patient. Thus, the "examination data" input further includes position information relative to the orientation aid fixed to the patient's body. This position information can be automatically evaluated by the computer program so as to directly output the position and / or angular orientation specifications relative to a patient coordinate system defined by the orientation aid.

[0034] According to an advantageous embodiment of the present invention, the orientation aid has a plurality of marker elements that can be automatically detected using X-ray, MRT, and / or ultrasound images. These marker elements can be spatially distributed on the orientation aid. For example, the marker elements can be arranged in a matrix on the orientation aid. It is also possible that only individual points of the orientation aid comprise marker elements, for example, two or three points. This also allows for automatic evaluation of the positioning of the orientation aid on the patient based on X-ray, MRT, and / or ultrasound images.

[0035] In the case of a larger number of marker elements distributed in a matrix, the marker elements can also be used to automatically detect surface irregularities of the patient's body in the area of ​​the orientation aid using X-ray, MRT and / or ultrasound images. Alternatively or additionally, such detection of surface irregularities can be performed directly by image processing of the X-ray, MRT and / or ultrasound images, without such a matrix of marker elements. Automatic detection of surface irregularities can also be achieved by a separate detection device placed in the area of ​​the patient, for example by a camera, stereo camera, laser scanner or similar detection equipment, which can also be used in combination with each other.

[0036] The object stated at the beginning is further achieved by a set of elements for carrying out examination and / or treatment of a patient, the set comprising at least: a) an orientation aid having marks disposed thereon defining a two-dimensional coordinate grid, the orientation aid having a fixation surface configured to fix the orientation aid to a patient; b) a computer with a computer program, or at least one such computer program for a computer, wherein the computer program The computer program, when executed on the computer, calculates coordinate assignments on the coordinate grid of the orientation aid and outputs the assignments to a user, - characteristic data of the orientation aid; - Patient test data; - configured to use at least one position on the patient selected by the user from the patient's examination data;

[0037] In summary, the set comprises at least two elements: an orientation aid and a computer with a computer program or the computer program itself. The computer program can be stored on a data carrier. The set can also comprise one or more additional elements, for example a needle guidance device. The orientation aid can be developed according to one or more of the various embodiments described above.

[0038] Such a set assists the physician in carrying out the various steps of the examination and / or treatment, for example in the case of a biopsy. The computer or computer program is advantageous as it assists the user in particular in locating the actual location of the object on the patient.

[0039] The computer program requires as input at least characteristic data of the orientation aids, such as specification values ​​for the size and distribution of the coordinate grid and, optionally, the positions of the marker elements. The characteristic data of the orientation aids can, for example, be pre-stored in the computer, and if different orientation aids are to be used, the characteristic data of the different orientation aids can be stored in the computer and options can be displayed for the user so that the user can select the particular orientation aid to use by entering it on the computer.

[0040] The computer program further requires as input the patient's examination data, which can be obtained as already described above, and at least one location on the patient selected by a user from the patient's examination data. A user, e.g., a doctor, can select a location on the patient, e.g., the intended puncture site, on an MRT image displayed on a computer screen, e.g., during a biopsy.

[0041] The computer program then generates as output the coordinate designations, eg X and Y coordinates, in the coordinate grid of the orientation aid and outputs these, eg on a display.

[0042] The object stated at the outset is further achieved by a computer program for a computer, which when the computer program is run on the computer: b1) position specifications for positioning the needle guidance device on the patient; and / or b2) one or more angular orientation values ​​for setting the angular orientation of the needle guidance element relative to the base element in at least one angular degree of freedom or in several mutually independent angular degrees of freedom; To calculate and output the specified value to the user, - characteristic data of the needle guidance device; - Patient test data; - at least one predetermined examination and / or treatment step performed using the needle guidance device.

[0043] The above advantages can also be achieved in this way.

[0044] The object stated at the outset is further achieved by a computer program for a computer, which, when the computer program is run on a computer, generates coordinate designations in a coordinate grid of an orientation aid. To calculate and output the specified value to the user, - characteristic data of the orientation aid; - Patient examination data and - configured to use at least one location on the patient selected by a user from the patient's medical examination data.

[0045] The advantages mentioned above can also be achieved in this way.The present invention also relates to a composite computer program comprising the functionality of the two computer programs mentioned above.

[0046] The invention will be explained in more detail below on the basis of exemplary embodiments and with reference to the drawings. [Brief explanation of the drawings]

[0047] [Figure 1] FIG. 1 shows an exploded view of a needle guidance device. [Figure 2] FIG. [Figure 3] FIG. 10 shows a retaining bracket. [Figure 4] FIG. 10 shows a retaining bracket. [Figure 5] FIG. 10 shows a clamping bracket. [Figure 6] FIG. 10 shows a needle guide element. [Figure 7] FIG. 10 shows a needle guide element receiver. [Figure 9] FIG. [Figure 10] FIG. [Figure 11] 10A-10C show needle guidance devices at different angle settings. [Figure 12] 10A-10C show needle guidance devices at different angle settings. [Figure 13] FIG. 1 shows a computer with a computer program. [Figure 14] FIG. 10 shows an orientation aid. [Figure 15] 10A-10C show further embodiments of orientation aids. [Figure 16] 13A-13C show further embodiments of the retaining bracket. [Figure 17] FIG. 10 is a highly schematic view showing a retaining bracket and a clamping bracket. [Figure 18] 1A-1C show a needle guidance device at various angle settings. [Figure 19] FIG. 10 is an explanatory diagram showing a clamping mechanism. DETAILED DESCRIPTION OF THE INVENTION

[0048] The needle guidance device 1 shown in FIG. 1 includes a needle guidance element 2, an operating element 3, a holding carriage 4, a holding bracket 5, a clamping bracket 6, a base element 7, a contact element 8, and a needle guidance element receiver 9. The contact element 8 is optional. For example, the contact element 8 may be used to secure the base element 7 to the patient's body. For this purpose, the contact element 8 may be provided with, for example, an adhesive. Alternatively, the underside of the base element 7 may be in direct contact with the patient's body. In this case, an adhesive may be disposed thereon. Overall, the needle guidance device 1 may comprise the seven components 2, 3, 4, 5, 6, 7, and 9 described above, which may be formed entirely or predominantly as plastic components.

[0049] These components are described in turn below.

[0050] 2 first shows the base element 7 in a perspective view. The base element 7 has a body 70 which can be designed in the form of a flat plate. On the underside of the body 70, the base element 7 can have a bearing face which rests on the patient's body. The contact element 8 described above can also be attached here.

[0051] The body 70 has a needle penetration opening 71 which is used to deliver a needle-like device into the patient's body. For example, in a biopsy, the puncture site of a biopsy needle can be located in the area of ​​the needle penetration opening 71. The body 70 also has a number of positioning marks 72, for example in the form of through-holes, which can be used to accurately position the needle guidance device 1 on the patient according to a patient coordinate system.

[0052] Furthermore, the body 70 may have further markings 73, for example information about a reference position, for example on the underside of the needle guidance device 1.

[0053] On either side of the needle opening 71, retaining arches 77 protrude from the body 70 and serve to retain and pivot the retaining bracket 5 on the base element 7. The retaining arches 77 have respective arcuate or semicircular recesses 78 to which the retaining bracket 5 can be pivotally mounted. Adjacent to each retaining arch 77, a bearing arch 75 protrudes from the base body 70. The outwardly facing curved surface of the bearing arch 75 also serves to form a pivot bearing for the retaining bracket 5. The bearing arch 75 also has an inner recess 76 that functions as part of the pivot bearing for the clamping bracket 6. Adjacent to the bearing arch 75, for example, on each side of the needle opening 71, a clamping arch 74 is disposed on the body 70. The curved outer surface of the clamping arch 74 serves as a further part of the pivot bearing for the clamping bracket 6. As can be seen, starting from the center of the body 70, or from the needle opening 71, there are first the clamping arches 74 on each side, then the bearing arches 75, and finally the retaining arches 77.

[0054] It can also be seen that a first angle scale 79 can be located on the face of the retaining arch 77 facing away from the needle through opening 71 .

[0055] FIG. 3 shows the retaining bracket 5 in a perspective view, and FIG. 4 shows the retaining bracket 5 in a side view. The retaining bracket 5 has an arc-shaped body 50 and a slit-like opening 51 extending longitudinally through which the needle guide element 2 or the needle guide element receiver 9 can be guided. At each of the mutually remote free ends, the retaining bracket 5 has a bearing element 52 whose curved outer surface contours are adapted to the inner surface contours of the opening 78 and the outer surface contours of the bearing arch 75 facing the retaining arch 77. In this way, the retaining bracket 5, which is disposed on the base element 7 between the retaining arch 77 and the bearing arch 75 by means of its bearing element 52, can be infinitely pivoted about the pivot axis thus formed. A first angle indicator 55 associated with a first angle scale 79 is disposed on the bearing element 52. The display of the first angle indicator 55 on the first angle scale 79 allows the angular orientation of the needle guide element 2 relative to the base element 7 in the first angular degree of freedom to be read.

[0056] 3 and 4 it can be seen that the holding bracket 5 can have structures, for example ridges, on its convexly curved outer surface 53, which serves as a support and sliding surface for the holding carriage 4. However, in order to allow as infinitely infinite adjustment of the holding carriage 4 on the outer surface 53 as possible, the surface structures or ridges can be slightly recessed relative to the edge region 54 of the outer surface 53, so that they only become active when the clamping mechanism is locked.

[0057] It can also be seen that a second angle scale 56 can be arranged on the retaining bracket 5 .

[0058] 5 shows the clamping bracket 6 in a perspective view. The clamping bracket 6 has a similar shape to the retaining bracket 5. The clamping bracket 6 has a body 60 that extends in an arcuate shape and has a longitudinally extending slit-like opening 61. The needle guide element 2 or the needle guide element receiver 9 can be guided through the slit-like opening 61. The concave inner surface 63 of the arcuate body 60 is formed with a retaining surface that serves as a counter-bearing for the needle guide element receiver 9, as will be described below.

[0059] Like the retaining bracket 5, the clamping bracket 6 has at each of its spaced apart free ends a bearing element 62 by means of which the clamping bracket 6 can be placed in an opening 76 in the base element 7. The bearing element 62 is then arranged between the interior of the bearing arch 75 and the outer surface of the clamping arch 74. In this way, a swivel bearing is formed for the clamping bracket 6 to swivel. The swivel axis of the clamping bracket 6 and the swivel axis of the retaining bracket 5 are the same.

[0060] FIG. 6 shows the needle guide element 2 in a perspective view on the left, a side view in the center, and a cross-sectional view along section AA on the right. The needle guide element 2 has a needle guide element 20, which can be designed, for example, as a hollow cylinder with an inner through-channel 21. The inner through-channel 21 extends longitudinally completely through the needle guide element 20. A needle-like device, such as a biopsy needle, can be guided through the inner channel 21. Above the needle guide element 20, the needle guide element 2 has a connection region 22 through which the needle guide element 2 can be coupled to the needle guide element receiver 9. Above the connection region 22, the needle guide element 2 has a manual manipulation region 23, which can have one or more gripping recesses 24, for example, to facilitate grasping the needle guide element 2 and manually inserting or removing it from the needle guidance device 1. The inner through-channel 21 also extends longitudinally through the connection region 22 and the manual manipulation region 23. At the upper end of the needle guiding element 2 , the internal through-channel 21 opens into an insertion opening 25 through which a needle-like device can be inserted into the needle guiding element 2 .

[0061] FIG. 7 shows the needle guide element receiver 9 in a perspective view on the left, a side view in the center, and a cross-sectional view along section AA on the right. The needle guide element receiver 9 serves to receive needle guide elements 2 of different designs. As a common connection point for the different designs of needle guide elements 2, the needle guide element receiver 9 has a longitudinally extending through-opening 91 whose dimensions are adapted to the outer dimensions of the needle guide 20 of the needle guide element 2. The needle guide element 2 is thus inserted with the needle guide 20 residing within the through-opening 91. When the needle guide element 2 is fully inserted into the needle guide element receiver 9, the connection region 22 is positioned within a holding portion 95 of the needle guide element receiver 9, where the needle guide element 2 is secured to the needle guide element receiver 9. The holding portion 95 can be designed in the form of two longitudinally protruding holding tabs whose peripheral edges are at least partially arcuate. This arcuate peripheral contour simultaneously provides a rotational position for the operating element 3.

[0062] The holding part 95 terminates at its free end with a circumferentially protruding fastening element 96, e.g., resembling a mushroom head. In this way, the operating element 3 can be captively coupled to the needle guide element receiving part 9. The operating element 3 is simply latched into place by being pressed against the holding part 95 and secured to the holding part 95 by the protruding fastening element 96. Below the holding part 95, the needle guide element receiving part 9 has a threaded area 94 designed as a screw that matches the internal thread of the operating element 3. Below the threaded area 94 is located a longitudinal part 90 of the needle guide element receiving part 9, which forms the connection between the holding bracket 5 and the clamping bracket 6 when the needle guidance device 1 is fully assembled. Below the longitudinal part 90, the needle guide element receiving part 9 transitions into a region 92 with an enlarged cross-section, which forms a bearing surface 93 that is arcuate in at least one viewing direction (Fig. 7: center). When the needle guidance device 1 is fully assembled, the arcuate bearing surface 93 contacts the concave inner surface 63 of the clamping bracket 6. In this way, part of the movable pivot bearing of the needle guidance element 2 is formed on the holding bracket 5 and the clamping bracket 6.

[0063] 9 shows the retaining carriage 4 in a perspective view. The retaining carriage 4 has a body 40 with an opening 41. A portion of the needle guide element receiving portion 9 is insertable through the opening 41, specifically through the upper portion of the vertical portion 90 that transitions into the threaded region 94. The retaining carriage 4 has a bearing surface on its underside, through which the retaining carriage 4 is guided on the convexly curved outer surface 53 of the retaining bracket 5, slides on it, or is clamped onto it upon activation of the clamping mechanism. A second angle indicator 42 is also disposed on the retaining carriage 4, which serves to indicate an angle on the second angle scale 56 of the retaining bracket 5.

[0064] 10 shows an operating element 3 which can be designed in the form of a nut with an internal thread 32 which can be screwed onto a threaded region 94 of the needle guide element receiver 9. The operating element 3 has an internal cavity 31 into which at least part of the needle guide element 2 can be inserted. On its outer periphery, the operating element 3 can have gripping elements 30 suitable for improving the transmission of operating forces, for example protrusions as shown in the figure, or some other surface structure and / or ridges on its outer periphery.

[0065] FIG. 11 shows the assembled needle guidance device 1 having the aforementioned elements, with the needle-like device 10 at least partially shown. The needle-like device 10 terminates at a tip 11 in the region of the through opening 71 of the base element 7. FIG. 11 shows the needle guidance device 1 in a configuration in which the angular orientation of the needle guidance element 2 is neutral for both adjustable angular degrees of freedom, i.e., the respective angle indicators 42, 55 point to the zero value of the respective angle scales 56, 79. In FIG. 12, the angular orientation has been adjusted, for example, so that the second angle indicator 42 points to an angle of approximately −20 degrees on the second angle scale 56. The first angle indicator 55 points to an angle of approximately +30 degrees on the first angle scale 79.

[0066] To adjust the needle guidance device 1 from one angular orientation to another, the operating element 3 is simply rotated slightly about its longitudinal axis, for example counterclockwise, which slightly adjusts the threaded connection between the internal thread 32 and the threaded region 94 and thereby cancels the clamping caused by the clamping bracket 6, which may be tensioned via the threaded connection and the needle guidance element receiver 9. Once the desired angular orientation is set, the operating element 3 is simply rotated in the opposite rotational direction, which tensions the clamping bracket 6 via the threaded connection 32, 94 and the needle guidance element receiver 9 and presses the clamping bracket 6 against the holding bracket 5. As a result, all degrees of freedom of pivoting and angular adjustment movement of the needle guidance device 1 are locked.

[0067] 13 shows a computer 100 having a computer program 101 as part of a set having multiple elements for performing examinations and / or treatments on a patient's body. The set can include any desired needle guidance device, such as a needle guidance device of the type described above, and / or an orientation aid of the type described above.

[0068] In the computer 100 or in the computer program 101, input data are entered as characteristic data 102 of the needle guidance devices included in the set, patient examination data 103, and data 104 of the predetermined examination and / or treatment steps to be performed using the needle guidance device. From this data, the computer program calculates positioning specifications 105 for positioning the needle guidance device on the patient and angular orientation specifications 106 for setting the angular orientation of the needle guidance element relative to the base element in two mutually independent angular degrees of freedom. The output positioning specifications and angular orientation specifications can be displayed, for example, on a display of the computer 100.

[0069] The set described above may comprise an orientation aid 200, for example the orientation aid 200 shown in Fig. 14. The orientation aid 200 has a grid-like structure 201, which may consist of flat, flexible sub-elements. Marks 202 for defining a two-dimensional coordinate grid may be arranged on these sub-elements. Furthermore, marker elements 203, for example in the form of a matrix, may be arranged at several points on the orientation aid 200. The marker elements 203 consist of a material that is detectable in X-ray, MRT and / or ultrasound examination and can therefore also be evaluated automatically by image processing.

[0070] Figure 15 shows a further embodiment of an orientation aid 200. While the embodiment according to Figure 14 has a grid of cross-connected elongate elements, Figure 15 shows an embodiment in which the grid 201 is applied to an at least substantially closed body, for example a sheet of paper or film. The grid 201 can for example be printed with marks 202 arranged thereon. The aforementioned marker elements 203 can also be present in this orientation aid 200.

[0071] If the foregoing itself only comprises an orientation aid 200 and a computer 100 or computer program 101, the computer program 101 can be designed so that the only input data required are characteristic data of the orientation aid 200, the patient's examination data, and at least one position on the patient selected by the user from the patient's examination data. From this data, the computer program 101 calculates coordinate assignments in the coordinate grid of the orientation aid and outputs these to the user, for example, the assignment value E4 for the position in the fourth row and fifth column.

[0072] FIG. 16 shows another embodiment of a retaining bracket 5 which, unlike the previously described embodiments, has no special structure on the convexly curved outer surfaces 53, but instead these outer surfaces 53 are designed with a relatively smooth surface, which is the normal surface of the material used.

[0073] 17 very diagrammatically shows the retaining bracket 5 and the clamping bracket 6, as well as the mutually perpendicular pivot axes X and Y along which the needle guidance device 1 can be adjusted in different angular directions. It can be seen that the retaining bracket 5 and the clamping bracket 6 each have a substantially arched shape, with the arches extending substantially parallel to one another. The retaining bracket 5 is located above the clamping bracket 6. Both the retaining bracket 5 and the clamping bracket 6 are pivotable about the Y axis. There is an open space below the clamping bracket 6, as there are no further arches in this area that are pivotable about the X axis.

[0074] Figure 18 shows that using three different angular directions A, B, C in which the needle guidance device 1 can be set, at each setting the needle-like device 10 is always guided through the same point P by the needle guidance element 2, i.e. the needle-like device 10 always has the same puncture point on the patient, regardless of the angle setting.

[0075] FIG. 19 shows the operation of the clamping mechanism using a partial view of the needle guidance device 1 (top) and a schematic view similar to FIG. 17 (bottom). Clamping can be achieved via the operating element 3, i.e., by tightening the nut with the internal thread 32 against the threaded region 94 of the needle guidance element receiving part 9. In this way, the holding bracket 5 is pressed against the clamping bracket 6, i.e., the clamping pulls the clamping bracket 6 slightly toward the holding bracket 5. This shortens the distance M shown in the figure. This slightly flattens the arch shape of the holding bracket 5, while slightly bending the clamping bracket 6 further. As a result, firstly, the needle guidance element 2 is fixed against pivoting about the X axis. Furthermore, forces F1 and F2 occurring in this transition region secure the holding bracket 5 and the clamping bracket 6 to the base element 7. [Explanation of symbols]

[0076] The reference symbols used in the figures indicate the following: 1. Needle guidance device 2 needle guide elements 3 Operational Elements 4 Retaining Carriage 5 Retaining bracket 6 Clamping bracket 7 Base Elements 8 Contact Elements 9 Needle guide element receiving part 10 Needle-shaped device 11 Tip 20 needle derivative 21 Penetration conduit 22 Connection Area 23 Manual operation area 24 Gripping recess 25 Insertion opening 30 Gripping elements 31 Cavity 32 Female thread 40 Main Unit 41 Aperture 42 Second Angle Indicator 50 main unit 51 Aperture 52 bearing element 53 Exterior 54 Edge Region 55 First Angle Indicator 56 Second Angle Scale 60 Main Unit 61 Aperture 62 Bearing elements 70 Main Unit 71 Needle-penetrating opening 72 Positioning mark 73 marks 74 Clamped Arch 75 Bearing Arch 76 Recess 77 Retaining Arch 78 Recess 79 First Angle Scale 90 Vertical section 91 Through opening 92 areas 93 Bearing surface 94 Thread Area 95 Holding part 96 Fixed Elements 100 computers 101 Computer Programs 102 Characteristic Data 103 Inspection Data 104 Test and / or treatment step data 105 Positioning specification value 106 Angle direction specification value 200 Orientation Assistance 201 Lattice structure 202 marks 203 Marker Elements

Claims

1. A needle guidance device (1) for guiding and positioning a needle-like device (10) on a patient, comprising: a base element (7); a needle guide element (2) on which the needle-like device (10) can be guided along its length, the angular orientation of the needle guide element (2) relative to the base element (7) being adjustable in two mutually independent angular degrees of freedom; an operating element (3) by which the angular orientation of the needle guide element (2) can be fixed or by which such fixing can be released again; an angle scale (56, 89) for each of the two angular degrees of freedom and an angle indicator (42, 55) associated with each angle scale (56, 89), such that the currently set angular orientation of the needle guidance element (2) in the two angular degrees of freedom is readable by a user based on the position of each angle indicator (42, 55) relative to its associated angle scale (56, 89); a retaining bracket (5) to which the needle guiding element (2) is fixed, such that in a first of the two angular degrees of freedom the retaining bracket (5) is movable relative to the base element (7) and in a second of the two angular degrees of freedom the needle guiding element (2) is movable relative to the retaining bracket (5); a clamping bracket (6) fixed to the base element (7) and pivotable relative to the base element (7) about the same pivot axis as the holding bracket (5); and When the operating element is operated, the needle guiding element is fixed in the second angular degree of freedom relative to the holding bracket, and the holding bracket and the clamping bracket are drawn together to be fixed in the first angular degree of freedom relative to the base element.

2. 2. The needle guidance device (1) according to claim 1, comprising a clamping mechanism actuatable by the operating element (3), characterized in that the angular orientation of the needle guidance element (2) relative to the base element (7) in the two angular degrees of freedom can be fixed by clamping by operating the clamping mechanism using the operating element (3).

3. 3. The needle guidance device (1) according to claim 1 or 2, characterized in that the angular orientation of the needle guidance element (2) relative to the base element (7) is steplessly adjustable in the two angular degrees of freedom.

4. 2. The needle guidance device (1) according to claim 1, characterized in that a first angle scale (56) is arranged on the holding bracket (5) and / or on the clamping bracket (6) and / or a second angle scale (89) is arranged on the base element (7) in the region of the fixing mechanism of the holding bracket (5).

5. 2. The needle guidance device (1) according to claim 1, characterized in that the operating element (3) is designed as an annular operating element (3) having an internal cavity (31), and at least a part of the needle guidance element (2) extends through the internal cavity (31).

6. A needle guidance device as described in claim 1, wherein each setting of the angular direction of the needle guidance element in the two angular degrees of freedom causes the needle-shaped device to contact the patient's body at the same position when guided by the needle guidance element.

7. A needle guidance device as described in claim 1, wherein the retaining bracket is arc-shaped.

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