Needle guide device and multi-element set

Description

[0001] The invention relates to a needle guidance device for guiding and positioning a needle-shaped device on a patient, wherein the needle guidance device comprises a base element and a needle guide element by which the needle-shaped device can be guided along its longitudinal extent, the angular orientation of the needle guide element relative to the base element being adjustable in two independent angular degrees of freedom. The invention further relates to a set with several elements for performing an examination and / or treatment of a patient.

[0002] In general, the invention relates to the field of medical devices that can be used for the examination and / or treatment of patients, for example, in the context of a biopsy or pain therapy. These procedures are usually performed manually under imaging guidance by ultrasound, computed tomography, or magnetic resonance imaging. It is already known to use a mechanical aid in the form of a needle guide to assist the physician, which simplifies the alignment of the biopsy needle and maintains it during the biopsy procedure. Such a needle guide is known, for example, from WO 2019 / 101862 A1.

[0003] US Patent 9,125,676 B2 discloses an adjustable needle guide device for image-guided intervention on patients. US Patent 4,883,053 discloses a self-stabilizing angulation device for precise percutaneous insertion of a needle or similar object. DE 100 29 737 A1 discloses a device for navigating a medical instrument. US Patent 2018 / 0228568 A1 discloses a medical guide device. US Patent 2009 / 0177077 A1 discloses MRI-compatible patches and methods for their use. EP Patent 1 958 588 A2 discloses a medical guide for guiding a medical instrument.

[0004] The invention is based on the objective of providing further improved aids for the examination and / or treatment of a patient using a needle-shaped device.

[0005] This problem is solved by the features of claim 1. This comprises a needle guidance device for guiding and positioning a needle-shaped device on a patient, wherein the needle guidance device has a base element and a needle guide element on which the needle-shaped device can be guided along its longitudinal extent, wherein the angular orientation of the needle guide element relative to the base element is adjustable in two independent angular degrees of freedom, with the following features: a) The needle guide device has an operating element by which the angular orientation of the needle guide element can be fixed in the two angular degrees of freedom or such a fixation can be released again, b) The needle guide device has an angular scale and an angular pointer assigned to the respective angular scale for each of the two adjustable angular degrees of freedom, so that the user can read the currently set angular orientation of the needle guide element in the two angular degrees of freedom by means of the position of the respective angular pointer relative to the assigned angular scale.

[0006] The needle guide device according to the invention significantly simplifies the execution of examinations and / or treatments of patients using a needle-shaped device, for example, during a biopsy. A single control element allows the angular orientation of the needle guide element to be fixed or released in two degrees of freedom. This makes the needle guide device suitable for one-handed operation, at least with regard to the actuation of the control element. Furthermore, the use of the needle guide device is simplified by the presence of corresponding angle scales and angle indicators for each of the two adjustable degrees of freedom. The user can thus quickly make the necessary angle adjustments by observing the angle indicators and scales, without the need for additional accessories.

[0007] The needle guide device can advantageously be designed such that, regardless of the angular orientation of the needle guide element within its two degrees of freedom, a needle-shaped device guided by the needle guide element always makes contact with the patient's body at the same position; that is, during a biopsy, the biopsy needle always encounters the same puncture site. The base element serves to attach the needle guide device to the patient's body, for example, using a removable adhesive.

[0008] The needle-shaped device can be, for example, a biopsy needle, an injection needle, or an ablation needle.

[0009] According to an advantageous embodiment of the invention, the needle guide device has a clamping mechanism that can be actuated by the control element, wherein the angular orientation of the needle guide element relative to the base element can be fixed by clamping the clamping mechanism via the control element in the two degrees of freedom. Such a clamping mechanism can be implemented in a relatively simple manner, for example, with threaded elements that can be tightened against each other, thereby clamping a portion of the needle guide device and enabling the angular orientation of the needle guide element to be fixed by clamping. In particular, a clamping mechanism allows for stepless adjustment of the angular orientation of the needle guide element relative to the base element in the two degrees of freedom.This eliminates the need for detents, allowing for virtually any angular orientation within the possible swivel range of the needle guide element. The angular orientation of the needle guide element can be adjusted in steps, for example, via detents, in at least one or both degrees of freedom.

[0010] According to an advantageous embodiment of the invention, the angular orientation of the needle guide element relative to the base element is continuously adjustable in both angular degrees of freedom. In this way, 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 guide device with regard to their adjustment options.

[0011] According to the invention, the needle guide device has a retaining bracket to which the needle guide element is attached. The retaining bracket is movable in a first of two angular degrees of freedom relative to the base element, and the needle guide element is movable in a second of two angular degrees of freedom relative to the retaining bracket. This allows for a simple and robust design of the needle guide device. The retaining bracket can, for example, be arc-shaped, and its arc shape facilitates arc-shaped movement of the needle guide element relative to the retaining bracket. The needle guide element can, for example, be guided on the retaining bracket by means of a carriage or a guide slide and be displaceable along the retaining bracket in an arc-shaped movement corresponding to the arc of the retaining bracket, and thus movable relative to the retaining bracket.The retaining bracket can, for example, be attached to the base element in a way that allows it to pivot around a pivot axis.

[0012] According to the invention, the needle guide device has a clamping bracket that is attached to the base element and pivotable about the same pivot axis relative to the base element as the retaining bracket. The clamping bracket can form part of the clamping mechanism. 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 direction, for example, the pivoting movement mentioned above. The clamping bracket can be arranged, for example, between the retaining bracket and the base element. The clamping bracket can, for example, be arc-shaped, e.g., with an arc that is concentric to the arc of the retaining bracket.

[0013] The retaining bracket and the clamping bracket can, for example, run at least substantially parallel to each other, i.e., form two arcs running substantially parallel to each other. A certain distance or clearance can exist between the retaining bracket and the clamping bracket. Due to the arc shape of at least the clamping bracket, the needle guide device has a clearance in the area between the clamping bracket and the base element, which is, for example, essentially circular or, with respect to the pivoting capability of the clamping bracket, hemispherical. The clamping bracket can be coupled to the retaining bracket with respect to its pivoting capability, so that the clamping bracket is always pivoted by the same angle as the retaining bracket.

[0014] When fixing the needle guide element in the two degrees of freedom using the control element, the retaining bracket and the clamping bracket can be clamped against each other, utilizing the space between the retaining bracket and the clamping bracket. This may cause slight deformation of the retaining bracket and / or the clamping bracket. Clamping on the base element can, for example, occur at arc-shaped sections of the base element where the retaining bracket and / or the clamping bracket are pivotally mounted. In this way, actuating one of the control elements can create a kind of "remote clamping," meaning that a clamping effect is also triggered at a point remote from the control element.

[0015] As mentioned, the needle guide device can be designed such that, regardless of the angular orientation of the needle guide element within its two degrees of freedom, a needle-shaped device guided by the needle guide element always makes contact with the patient's body at the same position. This means that during a biopsy, the biopsy needle always makes contact with the same puncture site. The base element can have a mounting surface on a patient-facing side for attaching it to the patient. For this purpose, the needle guide device can be designed such that both the pivot axis of the retaining bracket (X-axis) relative to the base element and the pivot axis of the needle guide element (Y-axis), defined by the arc shape of the retaining bracket, lie precisely in the plane of the mounting surface.

[0016] According to an advantageous embodiment of the invention, a first angle scale is arranged on the retaining bracket and / or the clamping bracket, and / or a second angle scale is arranged in the area of ​​a fastening arrangement of the retaining bracket to the base element. This has the advantage that the relatively large surfaces of these components—retaining bracket, clamping bracket, and base element—can be used for marking with a respective angle scale. In this way, the angle scale is easy to read. The first angle indicator associated with the first angle scale can, for example, be arranged on the needle guide element or a part connected to the needle guide element, such as the aforementioned retaining slide. The second angle indicator associated with the second angle scale can, for example, be arranged on the retaining bracket and / or the clamping bracket.

[0017] It is also advantageously possible to reverse the previously described assignment of the first angle scale to the retaining bracket and / or the clamping bracket with the associated angle pointer. In other words, the first angle pointer can also be located on the retaining bracket and / or the clamping bracket. In this case, for example, the first angle scale assigned to the first angle pointer can be located on the needle guide element or a component coupled to the needle guide element. The same applies to the second angle scale. Alternatively, the second angle pointer can be located in the area of ​​a mounting arrangement of the retaining bracket on the base element. In this case, for example, the second angle scale assigned to the second angle pointer can be located on the retaining bracket and / or the clamping bracket.

[0018] According to an advantageous embodiment of the invention, the needle guide device has a needle guide element receptacle designed to receive differently shaped needle guide elements of the needle guide device. This has the advantage that the needle guide device can be used very universally for a wide variety of examinations and / or treatments on patients. For example, the needle guide device can be adapted to needle-shaped devices with different diameters by exchanging a needle guide element.

[0019] According to an advantageous embodiment of the invention, the needle guide element receptacle extends from the retaining bracket to the clamping bracket. In this way, the retaining bracket can be coupled to the clamping bracket via the needle guide element receptacle. Accordingly, the entire needle guide device can be implemented with very few components, since the needle guide element receptacle can fulfill several functions, namely, receiving differently shaped needle guide elements and coupling the retaining bracket and the clamping bracket. Furthermore, another part of the clamping mechanism, for example a thread, can be arranged on the needle guide element receptacle.

[0020] According to an advantageous embodiment of the invention, the operating element is designed as an annular operating element with an inner cavity, wherein at least a portion of the needle guide element extends through the inner cavity. The operating element can, for example, be designed in the form of a nut with an internal thread. The internal thread can be a thread matching the thread of the needle guide element receptacle, so that the operating element can be screwed onto the needle guide element receptacle in the manner of a nut. This threaded connection between the operating element and the needle guide element receptacle allows the clamping mechanism to be activated, for example, by tightening the threaded connection, thus clamping the needle guide element to fix it relative to the base element in the two angular degrees of freedom. Furthermore, this allows for a particularly compact design of the needle guide device.

[0021] According to an advantageous embodiment of the invention, the base element has a contact surface for resting against the patient's body. This contact surface can, for example, have a narrow, elongated rectangular shape, optionally with rounded corners. In this way, the needle guide device requires very little space for the contact surface on the patient's body, making it highly versatile, for example, even for small patients. The contact surface can be designed as a flat surface.

[0022] The aforementioned problem is also solved by a set according to claim 6 comprising several

[0023] Elements for performing an examination and / or treatment on a patient's body, wherein the set includes at least the following elements: a) a needle guidance device according to the invention for guiding and positioning a needle-shaped device on the patient, wherein the needle guidance device comprises a base element and a needle guide element on which the needle-shaped device can be guided along its longitudinal extent, wherein the angular orientation of the needle guide element relative to the base element is adjustable in two independent angular degrees of freedom, wherein the base element comprises a base body having a needle passage opening and wherein the base body has several position markings, wherein by means of these position markings a precise positioning of the needle guidance device on the patient can be carried out according to a patient-related coordinate system, b) a computer with a computer program or at least such a computer program for a computer, wherein the computer program is configured toBased on the characteristics of the needle guide device, patient examination data from an imaging examination of the patient, and at least one predefined examination and / or treatment step to be performed with the needle guide device, the computer program calculates and outputs to the user, when the computer program is executed on the computer, the following: b1) positioning information for positioning the needle guide device on the patient and b2) one or more angular orientation information for setting the angular orientation of the needle guide element relative to the base element in the at least one angular degree of freedom or the several independent angular degrees of freedom.

[0024] In short, the set thus comprises at least two elements: the needle guide device and the computer with a computer program, or the computer program itself. The computer program can be stored on a data carrier. The set may also include one or more additional elements, such as the orientation aid explained below.

[0025] Such a set assists the physician in carrying out the various steps of the examination and / or treatment, for example, during a biopsy. In particular, the computer program can support the procedure by providing corresponding instructions for each step to be performed.

[0026] The computer is configured to execute the computer program, e.g., in the form of software. The computer can be a standard commercial computer, e.g., a PC, laptop, notebook, tablet, or smartphone, or a microprocessor, microcontroller, or FPGA, or a combination of such elements.

[0027] Advantageously, the computer or computer program assists the user, particularly in positioning the needle guide device on the patient and / or in adjusting the angular orientation of the needle guide 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 significantly simplifies the correct positioning and adjustment of the needle guide device for the user.

[0028] The computer program requires at least the key data of the needle guide device as input, for example, information about the geometry of an angle adjustment mechanism and the arrangement of reference points of the base element. The key data of the needle guide device can, for example, be pre-stored in the computer. If different needle guide devices are used, the computer can store the key data for each of these different devices and display a selection to the user, allowing them to select the desired needle guide direction by entering information into the computer.

[0029] The computer program requires patient examination data and at least one predefined examination and / or treatment step to be performed with the needle guidance device as input. The patient examination data can be data from an imaging examination, such as an X-ray, MRI, and / or ultrasound examination. The X-ray examination could, for example, be a CT scan. The resulting image data or DICOM files can be directly fed into the computer for processing by the program. The information about the examination or treatment step to be performed could, for example, include the coordinates of an insertion point of the needle-shaped device on the patient and a target point within the body, as specified by the user.

[0030] The aforementioned input data can be supplied to the computer via a wireless or wired interface and / or via manual input.

[0031] The computer program then generates the aforementioned positioning and / or angular orientation data as output. For example, the positioning data output includes the two-dimensional coordinates in a patient-specific coordinate system for at least two reference points, which could be located, for instance, on the base element of the needle guide device. Regarding angular orientation data, two angle values ​​can be output, for example, in degrees, relative to a 360-degree system. Using this positioning and / or angular orientation data, the user can then place the needle guide device at the desired location and in the desired position on the body and adjust the angular orientation of the needle guide element in the two degrees of freedom before or after placement.The needle guide device included in the set can, for example, be a needle guide device of the type described above, i.e., a needle guide device according to the invention, or a different type, for example, a known needle guide device. For instance, the needle guide device according to WO 2019 / 101 862 A1 can also be used.

[0032] According to an advantageous embodiment of the invention, the set includes as a further element an orientation aid with markings that define a two-dimensional coordinate grid. The orientation aid has a mounting surface designed for attaching it to the patient. Such an orientation aid makes the mapping of a patient-specific coordinate system to the coordinate system used by the computer program more reliable and straightforward. In particular, this mapping is simplified for the user, since only the orientation aid needs to be attached to the patient. Through automatic detection of the orientation aid on the patient, for example, by means of a camera and image analysis, corresponding characteristic data of the patient-specific coordinate system can be made available to the computer and the computer program.

[0033] The orientation aid can, for example, consist of several strips arranged at right angles to each other, forming a grid. Markings or scales can be attached to the individual strips, which are readable by the user and facilitate the visual identification of a desired coordinate position on the patient. The orientation aid can also have a largely closed surface, similar to a sheet of paper or a large adhesive bandage, onto which the two-dimensional coordinate grid is applied, for example, by printing.

[0034] The coordinate grid on the orientation aid can be printed on it or applied in some other way. The coordinate grid can be designed as a Cartesian coordinate system and can, for example, have a horizontal coordinate (X-coordinate) and a vertical coordinate (Y-coordinate). The coordinate axes can be labeled with numbers and / or letters.

[0035] According to an advantageous embodiment of the invention, the orientation aid is designed as a flat, flexible element. This has the advantage that the orientation aid can be easily attached to the patient even in areas with body curves and protrusions.

[0036] According to an advantageous embodiment of the invention, the patient's examination data includes positional information from the orientation aid attached to the patient. The computer program is configured to additionally calculate the output of the positioning data and / or the angular orientation data based on the positional information of the orientation aid on the patient. Accordingly, the input "examination data" additionally includes the positional information of the orientation aid attached to the patient's body. This positional information can be automatically evaluated by the computer program so that the positioning data and / or the angular orientation data can be output directly with respect to the patient-specific coordinate system defined by the orientation aid.

[0037] According to an advantageous embodiment of the invention, the orientation aid comprises several marker elements that can be automatically detected using X-ray, MRI, and / or ultrasound images. These marker elements can be spatially distributed across the orientation aid. For example, the marker elements can be arranged in a matrix-like pattern across the orientation aid. Alternatively, only individual points of the orientation aid can be equipped with marker elements, for example, two or three points. This also allows for automatic evaluation of the orientation aid's positioning on the patient based on the X-ray, MRI, and / or ultrasound images.

[0038] If a larger number of marker elements are present, distributed in a matrix-like pattern, these elements can also be used to automatically detect the surface contour of the patient's body in the area of ​​orientation using X-ray, MRI, and / or ultrasound images. Alternatively or additionally, such surface contour detection can also be performed directly through image processing of the X-ray, MRI, and / or ultrasound images, without the need for such a matrix of marker elements. Automatic determination of the surface contour is also possible using a separate detection device positioned near the patient, such as a camera, a stereoscopic camera, a laser scanner, or similar detection instruments, which can also be used in combination.

[0039] The aforementioned task is also solved by a computer program for a computer, the computer program being configured to use, based on Characteristics of a needle guidance device according to the invention for guiding and positioning a needle-shaped device on the patient, wherein the needle guidance device comprises a base element and a needle guide element on which the needle-shaped device can be guided along its longitudinal extent, wherein the angular orientation of the needle guide element relative to the base element is adjustable in two independent angular degrees of freedom, wherein the base element comprises a base body having a needle passage opening and wherein the base body has several position markings, wherein by means of these position markings a precise positioning of the needle guidance device on the patient can be carried out according to a patient-related coordinate system, examination data of the patient from an imaging examination of the patient and at least one predetermined,The computer program must calculate and output to the user, when the computer program is executed on the computer, the following parameters for the examination and / or treatment step to be performed with the needle guide device: b1) positioning information for positioning the needle guide device on the patient and b2) one or more angular orientation parameters for setting the angular orientation of the needle guide element relative to the base element in the at least one angular degree of freedom or the several independent angular degrees of freedom.

[0040] This also allows the previously explained advantages to be realized.

[0041] The invention is explained in more detail below with reference to exemplary embodiments and drawings.

[0042] They show: Figure 1 shows an exploded view of a needle guide device, Figure 2 a base element, Figures 3 and 4 a retaining bracket, Figure 5 a clamping bracket, Figure 6 a needle guide element, Figure 7 a needle guide element receptacle, Figure 9 a holding carriage, Figure 10 an operating element, Figures 11 and 12 the needle guide device in different angular settings, Figure 13 a computer with a computer program, Figure 14 an orientation aid, Figure 15 another embodiment of an orientation aid, Figure 16 another embodiment of a retaining bracket, Figure 17 a highly schematic representation of the retaining bracket and the clamping bracket, Figure 18 the needle guide device in different angular settings, and Figure 19 an explanation of the clamping mechanism.

[0043] The reference symbols used in the figures have the following assignment: 1 Needle guide device 2 Needle guide element 3 Operating element 4 Holding slide 5 Holding bracket 6 Clamping bracket 7 Base element 8 Contact element 9 Needle guide element receptacle 10 Needle-shaped device 11 Tip 20 Needle guide body 21 Through channel 22 Connection area 23 Handling area 24 Grip recesses 25 Insertion opening 30 Grip elements 31 Cavity 32 Internal thread 40 Base body 41 Opening 42 Second angle indicator 50 Base body 51 Opening 52 Bearing element 53 Outer surface 54 Edge area 55 First angle indicator 56 Second angle scale 60 Base body 61 Opening 62 Bearing element 70 Base body 71 Needle guide opening 72 Position marking 73 Marking 74 Clamping arc 75 Bearing arc 76 Recess 77 Retaining arc 78 Recess 79 First angle scale 90 Longitudinal section 91 Through opening 92 Area 93 Bearing surface 94 Threaded area 95 Retaining section 96 Fixing element 100 Computer 101 Computer program 102 Identification data 103 Examination data 104 Data of an examination and / or treatment step 105 Positioning information106Angle orientation information 200Orientation aid 201Grid-like structure 202Marking 203Marker element

[0044] The in Figure 1 The illustrated needle guide device 1 comprises a needle guide 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 guide element receptacle 9. The contact element 8 is optional. It serves, for example, to attach the base element 7 to a patient's body. For this purpose, the contact element 8 can be provided with an adhesive. Alternatively, the underside of the base element 7 can be brought into direct contact with the patient's body. In this case, an adhesive can be applied there. Overall, the needle guide device 1 can thus be implemented from only seven components 2, 3, 4, 5, 6, 7, and 9, which can be made entirely or predominantly of plastic components.

[0045] These components will be explained in turn below.

[0046] The Figure 2 Figure 1 shows the base element 7 in a perspective view. The base element 7 has a base body 70, which can be designed like a flat, planar plate. The base element 7 can have a contact surface on its underside for resting against the patient's body. The contact element 8 mentioned above can also be attached there.

[0047] The base body 70 has a needle guide opening 71, which serves to guide the needle-shaped device into the patient's body. The insertion point of the biopsy needle can be located, for example, in the area of ​​the needle guide opening 71 during a biopsy. Furthermore, the base body 70 has several position markings 72, for example, in the form of through-holes. These position markings 72 allow for precise positioning of the needle guide device 1 on the patient according to a patient-specific coordinate system.

[0048] In addition, the base body 70 can have further markings 73, for example information on a reference position, for example the underside of the needle guide device 1.

[0049] On both sides of the needle guide opening 71, retaining arches 77 project from the base body 70. These arches serve to hold and pivot the retaining bracket 5 on the base element 7. The retaining arches 77 each have arc-shaped or semicircular recesses 78 in which the retaining bracket 5 can be pivotally mounted. Adjacent to each retaining arch 77, a bearing arch 75 projects from the base body 70. The outwardly curved surface of the bearing arch 75 also serves to form a pivot bearing for the retaining bracket 5. The bearing arches 75 also have internal recesses 76, which serve as part of a pivot bearing for the clamping bracket 6. Adjacent to the bearing arches 75, e.g., on each side of the needle guide opening 71, a clamping arch 74 is arranged on the base body 70. The curved outer surface of the clamping arch 74 serves as a further part of the swivel bearing for the clamping bracket 6.As can be seen, starting from the center of the base body 70 or from the needle insertion opening 71, there is first a clamping arc 74 on each side, then a bearing arc 75 and finally a retaining arc 77.

[0050] It is also apparent that a first angular scale 79 may be arranged on the surface of the retaining arc 77 facing away from the needle insertion opening 71.

[0051] The Figure 3 shows the retaining bracket 5 in a perspective view, which Figure 4in a side view. The retaining bracket 5 has a base body 50, which is arc-shaped and has a slot-like, longitudinally extending opening 51 through which the needle guide element 2 or the needle guide element receptacle 9 can be guided. The retaining bracket 5 has a bearing element 52 at each of its two widely separated free ends, the curved outer contours of which are adapted to the inner contour of the opening 78 and to the outer contour of the bearing arc 75 facing the retaining arc 77. In this way, the retaining bracket 5, which is inserted on the base element 7 with its bearing element 52 between the retaining arc 77 and the bearing arc 75, can be pivoted continuously about a pivot axis formed in this way. A first angle indicator 55 is arranged on the bearing element 52, which is assigned to the first angle scale 79.The angular orientation of the needle guide element 2 relative to the base element 7 can be read in a first angular degree of freedom by the display of the first angle pointer 55 on the first angle scale 79.

[0052] It is evident in the Figures 3 and 4 Additionally, the retaining bracket 5 can have a textured surface, such as ribbing, on its convex outer surfaces 53. These outer surfaces 53 serve as a bearing and sliding surface for the retaining carriage 4. To ensure the most stepless adjustment possible of the retaining carriage 4 on the outer surfaces 53, the surface texture or ribbing can be slightly recessed relative to an edge region 54 of the outer surfaces 53, so that the surface texture or ribbing only becomes effective when the clamping mechanism is locked in place.

[0053] It can also be seen that a second angle scale 56 may be arranged on the retaining bracket 5.

[0054] The Figure 5 Figure 6 shows the clamping bracket 6 in a perspective view. The clamping bracket 6 is shaped similarly to the retaining bracket 5. The clamping bracket 6 has a base body 60 that is arc-shaped and has a slot-like opening 61 extending longitudinally. The needle guide element 2 or the needle guide element receptacle 9 can be guided through the slot-like opening 61. A retaining surface is formed on the concave inner surface 63 of the arc-shaped base body 60, which serves as a counter bearing for the needle guide element receptacle 9, as will be explained below.

[0055] Similar to the retaining bracket 5, the clamping bracket 6 has a bearing element 62 at each of its widely separated free ends, which allows the clamping bracket 6 to be positioned in the opening 76 of the base element 7. The bearing element 62 is then located between an inner surface of the bearing arch 75 and an outer surface of the clamping arch 74. In this way, a pivot bearing is formed for pivoting the clamping bracket 6. The pivot axes of the clamping bracket 6 and the retaining bracket 5 are identical.

[0056] The Figure 6Figure 2 shows the needle guide element 2 in a perspective view on the left, in a side view in the middle, and in a sectional view in section plane AA on the right. The needle guide element 2 has a needle guide body 20, which can be designed, for example, as a hollow cylindrical body with an internal passage channel 21. The internal passage channel 21 extends completely through the needle guide body 20 in the longitudinal direction. The needle-shaped device, for example, a biopsy needle, can be passed through the passage channel 21. The needle guide element 2 has a connection area 22 above the needle guide body 20, in which the needle guide element 2 can be coupled to the needle guide element receptacle 9.

[0057] Above the connection area 22, the needle guide element 2 has a manual handling area 23, which may, for example, have one or more grip recesses 24 that simplify grasping and manually inserting or removing the needle guide element 2 from the needle guide device 1. The inner passage channel 21 extends longitudinally through the connection area 22 and the manual handling area 23. At the upper end of the needle guide element 2, the inner passage channel 21 opens into an insertion opening 25, through which the needle-shaped device can be inserted into the needle guide element 2.

[0058] The Figure 7Figure 9 shows the needle guide element receptacle 9 in a perspective view on the left, in a side view in the middle, and in a sectional view in section plane AA on the right. The needle guide element receptacle 9 serves to accommodate differently designed needle guide elements 2. As a common interface for the differently designed needle guide elements 2, the needle guide element receptacle 9 has a longitudinally extending through-opening 91, the dimensions of which are adapted to the outer dimensions of the needle guide body 20 of the needle guide element 2. The needle guide element 2 is thus inserted into the through-opening 91 together with the needle guide body 20.When the needle guide element 2 is fully inserted into the needle guide element receptacle 9, the connection area 22 is located within a retaining section 95 of the needle guide element receptacle 9, where the needle guide element 2 is fixed to the needle guide element receptacle 9. The retaining section 95 can be designed in the form of two longitudinally projecting retaining tabs, which are at least partially arcuate on their circumference. This arcuate circumferential contour simultaneously provides a rotary bearing for the operating element 3.

[0059] The retaining section 95 can terminate at its free end with a circumferentially projecting fixing element 96, for example, similar to a mushroom cap shape. This allows the operating element 3 to be captively coupled to the needle guide element receptacle 9. The operating element 3 is simply snapped onto the retaining section 95 by being placed on it and secured by the projecting fixing elements 96.

[0060] Below the retaining section 95, the needle guide element receptacle 9 has a threaded section 94, which is designed as a thread matching an internal thread of the operating element 3. Below the threaded section 94 is a longitudinal section 90 of the needle guide element receptacle 9, which, in the fully assembled state of the needle guide device 1, establishes a connection between the retaining bracket 5 and the clamping bracket 6. Below the longitudinal section 90, the needle guide element receptacle 9 transitions into a section 92 with an enlarged cross-sectional area, which, at least in one viewing direction ( Figure 7(center) forms an arcuate bearing surface 93. In the fully assembled state of the needle guide device 1, the arcuate bearing surface 93 comes into contact with the concave inner surface 63 of the clamping bracket 6. In this way, part of the movable pivot bearing of the needle guide element 2 on the retaining bracket 5 and the clamping bracket 6 is formed.

[0061] The Figure 9Figure 1 shows the holding slide 4 in a perspective view. The holding slide 4 has a base body 40 with an opening 41. A portion of the needle guide element receptacle 9 can be inserted through the opening 41, in particular the upper part of the longitudinal section 90, which transitions into the threaded area 94. The holding slide 4 has bearing surfaces on its underside, over which the holding slide 4 is guided on the convexly curved outer surfaces 53 of the holding bracket 5 and slides on them, or, when the clamping mechanism is activated, is clamped onto them. The second angle indicator 42 is also arranged on the holding slide 4, which serves to indicate the angle on the second angle scale 56 of the holding bracket 5.

[0062] The Figure 10Figure 3 shows the operating element 3, which can be in the form of a nut with an internal thread 32. The internal thread 32 can be screwed onto the threaded area 94 of the needle guide element receptacle 9. The operating element 3 has an internal cavity 31 through which at least part of the needle guide element 2 can be inserted. The operating element 3 can have grip elements 30 on its outer circumference, which are suitable for improving the transmission of an operating force, such as the projections shown or other surface texturing and / or knurling on the outer circumference.

[0063] The Figure 11 Figure 1 shows the assembled needle guide device 1 with the elements already mentioned; in addition, a needle-shaped device 10 is at least partially shown. The needle-shaped device 10 terminates in the area of ​​the through-opening 71 of the base element 7 with a tip 11. Figure 11The needle guide device 1 is shown in a setting in which the angular orientation of the needle guide element 2 is neutral with respect to both adjustable angular degrees of freedom, that is, the respective angle pointers 42, 55 point to the zero value of the respective angle scale 56, 79. In the Figure 12 The angle orientation was adjusted so that, for example, 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.

[0064] To adjust the needle guide device 1 from one angular orientation to another, the operating element 3 simply needs to be rotated slightly around its longitudinal axis, for example, counterclockwise. This slightly adjusts the threaded connection between the internal thread 32 and the threaded section 94, thereby releasing the clamping force exerted by the clamping bracket 6, which can be tightened via the threaded connection and the needle guide element receptacle 9. Once the desired angular orientation is set, the operating element 3 simply needs to be rotated in the opposite direction. This exerts a clamping force on the clamping bracket 6 via the threaded connection 32, 94 and the needle guide element receptacle 9, thus clamping the clamping bracket 6 against the retaining bracket 5. This fixes all degrees of swivel or movement of the angular adjustment of the needle guide device 1.

[0065] The Figure 13 Figure 1 shows a computer 100, which includes a computer program 101, as part of a set with several elements for performing an examination and / or treatment on a patient's body. The set may include any needle guidance device, for example, a needle guidance device of the type described above, and / or an orientation aid of the type described above.

[0066] The computer 100, or rather the computer program 101, receives input data including characteristic data 102 of the needle guide device included in the set, examination data 103 of a patient, and data 104 of a predefined examination and / or treatment step to be performed using the needle guide device. From this, the computer program calculates positioning data 105 for positioning the needle guide device on the patient, as well as angular orientation data 106 for setting the angular orientation of the needle guide element relative to the base element in the two independent angular degrees of freedom. The output positioning and angular orientation data can, for example, be displayed on a screen of the computer 100.

[0067] The aforementioned set may include a guide 200, for example, the one in Figure 14The orientation aid 200 shown has a grid-like structure 201, which can be formed from flat, flexible sub-elements. Markings 202 can be arranged on these sub-elements to define a two-dimensional coordinate grid. In addition, marker elements 203 can be arranged at several locations on the orientation aid 200, for example, in a matrix-like pattern. The marker elements 203 are made of a material that can be detected in X-ray-based, MRI, and / or ultrasound examinations and can therefore also be automatically evaluated by image processing.

[0068] The Figure 15 shows another embodiment of an orientation aid 200. While the embodiment according to Figure 14 exhibiting a grid-like structure made up of elongated elements interlocked in a crisscross pattern, the Figure 15An embodiment in which the grid-like structure 201 is applied to a base body that is at least substantially closed, e.g., a sheet of paper or a film. The grid-like structure 201, together with the markings 202 arranged thereon, can, for example, be printed on it. The aforementioned marker elements 203 can also be present in this orientation aid 200.

[0069] If the aforementioned device itself only comprises the orientation aid 200 and the computer 100 or the computer program 101, the computer program 101 can be designed such that the only required input data are the characteristics 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. The computer program 101 then calculates coordinate values ​​in the coordinate grid of the orientation aid and outputs these to the user, e.g., the value E 4 for a position in the fourth row and the fifth column.

[0070] The Figure 16shows an alternative embodiment of the retaining bracket 5, in which, unlike the embodiment described so far, there is no special structuring on the convexly curved outer surfaces 53, but these outer surfaces 53 are formed with the relatively smooth surface normal for the material used.

[0071] The Figure 17The figure shows, in a highly schematic fashion, the retaining bracket 5 and the clamping bracket 6, as well as the mutually orthogonal pivoting axes X and Y, in which the needle guide device 1 can be adjusted to various angular orientations. It can be seen that the retaining bracket 5 and the clamping bracket 6 are each essentially arc-shaped, with these arcs running essentially parallel to each other. The retaining bracket 5 is located above the clamping bracket 6. Both the retaining bracket 5 and the clamping bracket 6 can be pivoted about the Y-axis. Since there is no further arc in this area for pivoting about the X-axis, there is a gap below the clamping bracket 6.

[0072] The Figure 18This is illustrated by three different angular orientations A, B, C, into which the needle guide device 1 can be set, showing that in each setting the needle-shaped device 10 is always guided through the same point P by the needle guide element 2, i.e. the same insertion point on the patient always results for the needle-shaped device 10, regardless of the angular setting.

[0073] The Figure 19 illustrated by partial representations of the needle guide device 1 (above) and the schematic representation similar Figure 17(Below) the operating principle of the clamping mechanism. The clamping is initiated via the operating element 3, i.e., by tightening the nut with the internal thread 32 against the threaded area 94 of the needle guide element receptacle 9. This pre-tensions the retaining bracket 5 against the clamping bracket 6; that is, tightening the nut pulls the clamping bracket 6 slightly towards the retaining bracket 5. The distance M shown is thereby reduced. The arc shape of the retaining bracket 5 is thus flattened somewhat, while the clamping bracket 6 is bent slightly more. This initially fixes the needle guide element 2 with respect to its pivotability about the X-axis. Furthermore, the forces F1 and F2 occurring in this transition area fix the retaining bracket 5 and the clamping bracket 6 to the base element 7.

Claims

1. Needle guiding device (1) for guiding and positioning a needle-shaped device (10) on a patient, wherein the needle guiding device (1) comprises a base element (7) and a needle guiding element (2) on which the needle-shaped device (10) can be guided along the longitudinal extent thereof, wherein the angular orientation of the needle guiding element (2) relative to the base element (7) can be set in two mutually independent degrees of angular freedom, comprising the following features: (a) the needle guiding device (1) comprises an operating element (3) by means of which the angular orientation of the needle guiding element (2) can be fixed in two degrees of angular freedom or such fixing can be undone again, (b) the needle guiding device (1) comprises, for each of the two settable degrees of angular freedom, an angle scale and an angle indicator (42, 55) assigned to the relevant angle scale (56, 89), such that a currently set angular orientation of the needle guiding element (2) in the two degrees of angular freedom can be read by the user based on the position of the relevant angle indicator (42, 55) relative to the assigned angle scale (56, 89), wherein the needle guiding device (1) comprises a retaining bracket (5) to which the needle guiding element (2) is fastened, wherein the retaining bracket (5) can be moved in a first of the two degrees of angular freedom relative to the base element (7) and the needle guiding element (2) can be moved in a second of the two degrees of angular freedom relative to the retaining bracket (5), characterised in that the needle guiding device (1) comprises a clamping bracket (6) which is fastened to the base element (7) and can be pivoted about the same pivot axis relative to the base element (7) as the retaining bracket (5).

2. Needle guiding device (1) according to claim 1, characterised in that the needle guiding device (1) comprises a clamping mechanism that can be actuated by means of the operating element (3), wherein the angular orientation of the needle guiding element (2) relative to the base element (7) in the two degrees of angular freedom can be fixed by means of clamping by operating the clamping mechanism using the operating element (3).

3. Needle guiding device (1) according to any of the preceding claims, characterised in that the angular orientation of the needle guiding element (2) relative to the base element (7) is infinitely adjustable in the two degrees of angular freedom.

4. Needle guiding device (1) according to any of claims 1 to 3, characterised in that a first angle scale (56) is arranged on the retaining bracket (5) and / or clamping bracket (6) and / or a second angle scale (89) is arranged in the region of a fastening assembly of the retaining bracket (5) to the base element (7).

5. Needle guiding device (1) according to any of the preceding claims, characterised in that the operating element (3) is designed as an annular operating element (3) comprising an internal cavity (31), wherein at least part of the needle guiding element (2) extends through the internal cavity (31).

6. Set comprising a plurality of elements for carrying out an examination and / or treatment of a patient, wherein the set comprises at least the following elements: a) the needle guiding device (1) according to any of claims 1 to 5, wherein the base element (7) comprises a main body (70) which comprises a needle passage opening (71) and wherein the main body (70) comprises a plurality of position markings (72), wherein precise positioning of the needle guiding device (1) on the patient in accordance with a patient-related coordinate system can take place using these position markings (72), b) a computer (100) comprising a computer program (101) or at least a computer program (101) of this kind for a computer (100), wherein the computer program (101) is configured, on the basis of characteristic data of the needle guiding device (1), examination data relating to the patient from an imaging examination of the patient and at least one predefined examination and / or treatment step to be carried out with the needle guiding device (1), to calculate b1) positioning information for positioning the needle guiding device (1) on the patient and b2) one of more items of angular orientation information for setting the angular orientation of the needle guiding element (2) relative to the base element (7) in the at least one degree of angular freedom or the plurality of mutually independent degrees of angular freedom and to output same to the user when the computer program (101) is executed on the computer (100).

7. Set according to claim 6, characterised in that the examination data relating to the patient include examination data from an X-ray-based, MRT and / or ultrasound examination.

8. Set according to any of claims 6 or 7, characterised in that the set comprises an orientation aid (200) as a further element, on which markings (202) are provided which define a two-dimensional coordinate grid, wherein the orientation aid (200) comprises a fastening surface that is designed to fasten the orientation aid (200) to the patient.

9. Set according to claim 8, characterised in that the orientation aid (200) is designed as a flat flexible element.

10. Set according to any of claims 8 or 9, characterised in that the examination data relating to the patient contain position information relating to the orientation aid (200) fastened to the patient, wherein the computer program (101) is configured to calculate the output of the positioning information and / or angular orientation information additionally depending on the position information relating to the orientation aid (200) on the patient.

11. Set according to any of claims 8 to 10, characterised in that the orientation aid (200) comprises a plurality of marker elements (203) which can be automatically detected based on X-ray-based, MRT or ultrasound images.

12. Computer program (101) for a computer (100), wherein the computer program (101) is configured to calculate, based on - characteristic data of a needle guiding device (1) according to any of claims 1 to 5, wherein the base element (7) comprises a main body (70) which comprises a needle passage opening (71) and wherein the main body (70) comprises a plurality of position markings (72), wherein precise positioning of the needle guiding device (1) on the patient in accordance with a patient-related coordinate system can take place using these position markings (72), - examination data relating to a patient from an imaging examination of the patient and - at least one predefined examination and / or treatment step to be carried out with the needle guiding device (1), b1) position information for positioning the needle guiding device (1) on the patient and b2) one of more items of angular orientation information for setting the angular orientation of the needle guiding element (2) relative to the base element (7) in the two mutually independent degrees of angular freedom and to output same to the user when the computer program (101) is executed on the computer (100).