Needle guiding device and kit with multiple components

Abstract

A needle guiding device for guiding and positioning a needle-like device on a patient, wherein the needle guiding device has a base element and a needle guiding element along which the needle-like device can be guided longitudinally, and wherein the angular orientation of the needle guiding element relative to the base element can be set in two mutually independent angular degrees of freedom. The needle guiding device has an operating element by means of which the angular orientation of the needle guiding element can be fixed in the two angular degrees of freedom or such fixation can be released again. Furthermore, the needle guiding device has an angular scale and an angular indicator associated with the respective angular scale for each of the two adjustable angular degrees of freedom, such that a user can read the currently set angular orientation of the needle guiding element in the two angular degrees of freedom according to the position of the respective angular indicator relative to the associated angular scale.

Description

Field of the Invention

[0001] The present invention relates to a needle guiding device for guiding and positioning a needle-like device on a patient, wherein the needle guiding device has a base element and a needle guiding element, along which longitudinal extension the needle-like device can be guided at the needle guiding element, and wherein the angular orientation of the needle guiding element relative to the base element can be set in two mutually independent angular degrees of freedom. The present invention also relates to a kit having a plurality of elements for performing an examination and / or treatment of a patient. Background Art

[0002] Generally speaking, the present invention relates to the field of medical devices that can be used for examining and / or treating patients, for example, during a biopsy or a pain treatment procedure. These procedures are usually performed manually under the conditions of ultrasound, computed tomography or magnetic resonance imaging. It is known to use a mechanical assistance device in the form of a needle guiding device to assist a doctor, which simplifies the orientation of a biopsy needle and maintains the orientation during the performance of a biopsy. Such a needle guiding device is known, for example, from WO 2019 / 101862 A1. Summary of the Invention

[0003] The present invention is based on the following object: to provide a further improved assistance mechanism for examining and / or treating a patient under the condition of using a needle-like device.

[0004] This object is achieved by a needle guiding device for guiding and positioning a needle-like device on a patient, wherein the needle guiding device has a base element and a needle guiding element, along which longitudinal extension the needle-like device can be guided at the needle guiding element, and wherein the angular orientation of the needle guiding element relative to the base element can be set in two mutually independent angular degrees of freedom, and the needle guiding device has the following features:

[0005] a) The needle guiding device has an operating element by which the angular orientation of the needle guiding element can be fixed in two angular degrees of freedom or this fixation can be released again.

[0006] b) The needle guiding device has an angular scale and an angular indicator associated with the corresponding angular scale for each of the two adjustable angular degrees of freedom, such that a user can read the currently set angular orientation of the needle guiding element in the two angular degrees of freedom according to the position of the corresponding angular indicator relative to the associated angular scale.

[0007] The needle guidance device according to the invention significantly simplifies the performance of examinations and / or treatments on a patient with the aid of a needle-like device, for example in the case of a biopsy. Thus, the angular orientation of the needle guidance element can be fixed or released again in two angular degrees of freedom by a single operating element. In this way, the needle guidance device is suitable for single-handed operation, at least with regard to the actuation of the operating element. In addition, the use of the needle guidance device is simplified by the presence of a respective angular scale and an associated angular indicator for each of the two adjustable angular degrees of freedom. In this way, the user can quickly perform the required angular setting by observing the angular indicator and the angular scale without additional accessories.

[0008] The needle guidance device can advantageously be configured such that, when setting the angular orientation of the needle guidance element in two angular degrees of freedom each time, the needle-like device guided by the needle guidance element always contacts the patient's body at the same location, that is to say, during a biopsy, the biopsy needle always hits the same puncture site. A base element is used here for positioning the needle guidance device on the patient's body, for example by means of a releasable adhesive.

[0009] The needle-like device can be, for example, a biopsy needle, an injection needle or an ablation needle.

[0010] According to an advantageous embodiment of the invention, the needle guidance device has a clamping mechanism that can be actuated by an operating element, wherein 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 by means of the operating element. Such a clamping mechanism can be realized in a relatively simple manner, for example by means of threaded elements that can be screwed together, by means of which parts of the needle guidance device are tensioned against each other and in this way the angular orientation of the needle guidance element is fixed by clamping. By means of the clamping mechanism, in particular a stepless adjustment of the angular orientation of the needle guidance element relative to the base element in two angular degrees of freedom can be achieved. In this way, locking can be avoided, so that in principle any angular orientation can be set within the possible pivoting range of the needle guidance element. The setting of the angular orientation of the needle guidance element can also be carried out stepwise in at least one or both of the angular degrees of freedom, for example via locking elements.

[0011] According to an advantageous embodiment of the invention, the angular orientation of the needle guidance element relative to the base element in two angular degrees of freedom can be set steplessly. In this way, it is possible to set the angular orientation in two angular degrees of freedom arbitrarily in practice, so that the user is not restricted in terms of its setting feasibility by the design of the needle guidance device.

[0012] According to an advantageous design of the present invention, the needle guiding device has a holding bow, to which the needle guiding element is fixed, wherein the holding bow is movable relative to the base element in a first degree of angular freedom of two degrees of angular freedom, and the needle guiding element is movable relative to the holding bow in a second degree of angular freedom of two degrees of angular freedom. This allows for a simple and robust design of the needle guiding device. The holding bow can be configured in an arcuate shape, for example, and its arcuate shape aids the arcuate movability of the needle guiding element relative to the holding bow. The needle guiding element can be guided on the holding bow in the type of a slider or by means of a holding slider, for example, and can be moved along the holding bow in an arcuate movement corresponding to the arcuate shape of the holding bow and can move relative to the holding bow in this way. The holding bow can be fixed to the base element in a pivotable manner about a pivot axis, for example.

[0013] According to an advantageous design of the present invention, the needle guiding device has a clamping bow, which is fixed to the base element and is pivotable relative to the base element about the same pivot axis as the holding bow. The clamping bow can form part of the clamping mechanism mentioned here. The clamping bow can be coupled to the holding bow, for example, such that when the holding bow moves relative to the base element, the clamping bow performs the same movement, for example, the pivot movement mentioned. The clamping bow can be arranged between the holding bow and the base element, for example. The clamping bow can be configured in an arcuate shape, for example, having an arcuate shape that extends concentrically with the arcuate shape of the holding bow.

[0014] For example, the holding bow and the clamping bow can extend at least substantially parallel to each other, that is, form two bows that extend substantially parallel to each other. Here, there can be a certain distance or gap between the holding bow and the clamping bow. Due to the arcuate shape of at least the clamping bow, the needle guiding device has a gap in the region between the clamping bow and the base element, which gap is substantially circular or hemispherical with respect to the pivotability of the clamping bow. The clamping bow can be coupled to the holding bow in terms of pivotability such that the clamping bow and the holding bow always pivot through the same angle.

[0015] When the needle guiding element is fixed in two degrees of angular freedom by means of an operating element, the holding bow and the clamping bow can be tensioned against each other, and for this purpose, the gap between the holding bow and the clamping bow can be used. Here, the holding bow and / or the clamping bow may be slightly deformed. The clamping at the base element can be carried out, for example, on an arcuate region of the base element, on which the holding bow and / or the clamping bow are pivotably supported. In this way, a kind of "remote clamping" can be carried out by manipulating one operating element, that is, the clamping effect can also be triggered at a position far from the operating element.

[0016] As mentioned, the needle guiding device can be configured such that each time the angular orientation of the needle guiding element in two angular degrees of freedom is set, the needle-like device guided by the needle guiding element always contacts the patient's body at the same position, that is, during a biopsy, the biopsy needle always hits the same puncture site. The base element can have a fixing surface on the side facing the patient, through which the base element is fixed to the patient. For this purpose, the needle guiding device can be configured such that the pivot axis (X-axis) of the holding bow relative to the base element and the pivot axis (Y-axis) of the needle guiding element relative to the base element defined by the arcuate shape of the holding bow extend precisely in the plane of the fixing surface.

[0017] According to an advantageous design of the invention, a first angular scale is provided on the holding bow and / or the clamping bow, and / or a second angular scale is provided in the region of the fixing means of the holding bow on the base element. This has the advantage that the existing, relatively large surfaces of these components, namely the holding bow, the clamping bow, and the base element, can be used for textual description by means of the corresponding angular scales. In this way, the angular scales can be easily read. The first angular indicator associated with the first angular scale can be provided, for example, on the needle guiding element or on a component connected to the needle guiding element, such as the aforementioned holding bow. The second angular indicator associated with the second angular scale can be provided, for example, on the holding bow and / or the clamping bow.

[0018] It is also advantageously possible to exchange the previously described association of the first angular scale with the holding bow and / or the clamping bow with the associated angular indicator. In other words, the first angular indicator can also be provided on the holding bow and / or the clamping bow. In this case, the first angular scale associated with the first angular indicator can be provided, for example, on the needle guiding element or on a component coupled to the needle guiding element. This also applies in a corresponding manner to the second angular scale. Thus, alternatively, the second angular indicator can be provided in the region of the fixing means of the holding bow on the base element. In this case, the second angular scale associated with the second angular indicator can be provided on the holding bow and / or the clamping bow.

[0019] According to an advantageous design of the invention, the needle guiding device has a needle guiding element receptacle configured to accommodate differently configured needle guiding elements of the needle guiding device. This has the advantage that the needle guiding device can be used very generally for various examinations and / or treatments on a patient. For example, the needle guiding device can be adapted to needle-like devices with different diameters by replacing the needle guiding element.

[0020] According to an advantageous design of the invention, the needle guide element receiving part extends from the holding bow towards the clamping bow. In this way, the holding bow can be coupled to the clamping bow via the needle guide element receiving part. Correspondingly, the entire needle guide device can be implemented with few components, since the needle guide element receiving part can perform multiple functions, namely: accommodating differently configured needle guide elements and coupling between the holding bow and the clamping bow. In addition, another part of the clamping mechanism, such as a thread, can be provided on the needle guide element receiving part.

[0021] According to an advantageous design of the invention, the operating element is configured as an annular operating element having an internal cavity, wherein at least a part of the needle guide element extends through the internal cavity. The operating element can be configured, for example, in the manner of a nut with an internal thread. The internal thread can be a thread that matches the thread of the needle guide element receiving part, such that the operating element can be screwed onto the needle guide element receiving part in the manner of a nut. The clamping mechanism can be activated by a threaded connection between the operating element and the needle guide element receiving part, for example, by tightening the threaded connection for clamping to fix the needle guide element relative to the base element in two angular degrees of freedom. In addition, a particularly compact construction of the needle guide device can be achieved thereby.

[0022] According to an advantageous design of the invention, the base element has a support surface for supporting on the patient's body. For example, the support surface can have a narrow, elongated rectangular shape, optionally with rounded corners. In this way, the needle guide device requires only a small space for the support surface on the patient's body, such that the needle guide device can be used extremely universally, for example, even in small patients. The support surface can be configured as a flat surface.

[0023] The object mentioned at the beginning is also achieved by a kit having a plurality of elements for performing examinations and / or treatments at the patient's body, wherein the kit at least has the following elements:

[0024] a) A needle guide device for guiding and positioning a needle-shaped device on a patient, wherein the needle guide device has a base element and a needle guide element, and the needle-shaped device can be guided along its longitudinal extension on the needle guide element, wherein the angular orientation of the needle guide element relative to the base element can be set in at least one angular degree of freedom or a plurality of mutually independent angular degrees of freedom, for example, in two or three mutually independent angular degrees of freedom,

[0025] b) A computer or at least one such computer program for a computer having a computer program, wherein the computer program is designed to: when the computer program is executed on the computer, according to

[0026] - characteristic data of the needle guide device,

[0027] - The examination data of the patient, and

[0028] - At least one preset examination and / or treatment step to be performed with the aid of a needle guiding device, to calculate and output to the user

[0029] b1) Positioning data for positioning the needle guiding device on the patient,

[0030] and / or

[0031] b2) One or more angular orientation data, which are used to set the angular orientation of the needle guiding element relative to the base element in at least one angular degree of freedom or multiple mutually independent angular degrees of freedom.

[0032] In short, the kit thus has at least two elements, namely a needle guiding device and a computer with a computer program or the computer program itself. The computer program can be stored on a data carrier. The kit can also have one or more additional elements, such as an orientation aid to be discussed below.

[0033] Such a kit assists the doctor, for example, in performing different steps of an examination and / or treatment, especially in the case of a biopsy. In particular, the computer program can assist the method flow in such a way that the computer program or the computer outputs corresponding guiding steps for each method step to be performed.

[0034] The computer is set up to execute the computer program, for example in terms of software. The computer can be configured as a commercially available computer, such as a PC, laptop, notebook, tablet or smartphone, or as a microprocessor, microcontroller or FPGA, or a combination of these elements.

[0035] Advantageously, the computer or the computer program assists the user, especially when positioning the needle guiding device on the patient and / or when setting the angular orientation of the needle guiding device relative to the base element in at least one angular degree of freedom or multiple mutually independent angular degrees of freedom. In other words, the computer program can make it significantly easier for the user to correctly position and set the needle guiding device.

[0036] The computer program requires at least the characteristic data of the needle guiding device as input, such as data on the geometry of the angle adjustment mechanism and the setting of the reference points of the base element. The characteristic data of the needle guiding device can, for example, be pre-stored in the computer, where the characteristic data of different needle guiding devices can be stored in the computer respectively when different needle guiding devices are applied, and the selection can be displayed to the user, so that the user can select the corresponding needle guiding device to be used through input on the computer.

[0037] The computer program also requires the examination data of the patient and at least one preset examination and / or treatment step to be performed with the aid of a needle guidance device as input. The examination data of the patient can be data from an imaging examination of the patient, such as data from an X-ray-based, MRT, and / or ultrasound examination. The X-ray-based examination can be, for example, a CT examination. For example, the image data or DICOM file thus obtained can be directly fed to the computer for processing with the aid of the computer program. The description of the examination or treatment step to be performed can be, for example, the coordinates preset by the user for the puncture point of the needle-shaped device on the patient and the target point located in the body.

[0038] The input data mentioned can be fed to the computer via a wireless or wired interface and / or via manual input.

[0039] The computer program then generates the mentioned positioning data and / or angular orientation data as output. As positioning data, for example, the two-dimensional coordinates for at least two reference points in a patient-related coordinate system are output, and the reference points can be located, for example, on the base element of the needle guidance device. Regarding the angular orientation data, two angular specifications can be output: based on a 360-degree system, for example, in degrees. The user can then place the needle guidance device on the body at the desired location and position with the aid of this positioning data and / or angular orientation data, and set the angular orientation of the needle guidance element in two angular degrees of freedom before or after this placement. The needle guidance device included in the kit can be, for example, a needle guidance device of the above type, i.e., a needle guidance device according to the present invention, or can be of a different type, such as a known needle guidance device. Therefore, for example, a needle guidance device according to WO 2019 / 101862A1 can also be used.

[0040] According to an advantageous design of the present invention, the kit has an orientation aid as another element, on which a marker is arranged, the marker defining a two-dimensional coordinate grid, and the orientation aid has a fixing surface, which is provided for fixing the orientation aid on the patient. With this orientation aid, the correlation between the patient-related coordinate system and the coordinate system used by the computer program is designed more simply and reliably. In particular, this correlation is simplified for the user because it is only necessary to place the orientation aid on the patient, and by automatically detecting the orientation aid on the patient, for example, with the aid of a camera and image evaluation, the corresponding characteristic data of the patient-related coordinate system can be provided to the computer and the computer program.

[0041] The orientation aid can for example consist of a plurality of strips arranged at right angles to one another, which strips are joined to form a grid. Marks or graduations can be arranged on the individual strips, which can be read by the user and simplify the optical identification 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 a large-area patch, on which for example a two-dimensional coordinate grid can be applied by printing.

[0042] For example, the coordinate grid can be printed or otherwise applied to the orientation aid. The coordinate grid can be designed in terms of a Cartesian coordinate system and can for example have for example horizontal coordinates (X coordinates) and vertical coordinates (Y coordinates). For example, the coordinate axes can be labeled with numbers and / or letters.

[0043] According to an advantageous design of the invention, the orientation aid is configured as a flat, flexible element. This has the advantage that the orientation aid can be placed on the patient without problems even in regions of the body that are bent and bulging.

[0044] According to an advantageous design of the invention, the examination data of the patient contains position information of the orientation aid fixed to the patient, wherein a computer program is set up to additionally calculate the output of positioning data and / or angular orientation data based on the position information of the orientation aid on the patient. Correspondingly, the input, namely the "examination data", additionally contains position information of the orientation aid fixed to the patient's body. This position information can be automatically evaluated by the computer program such that the positioning data and / or angular orientation data can be output directly relative to the patient-related coordinate system defined by the orientation aid.

[0045] According to an advantageous design of the invention, the orientation aid has a plurality of marking elements which can be automatically detected based on X-ray images, MRT images and / or ultrasound images. These marking elements can in this case be arranged spatially distributed on the orientation aid. For example, the marking elements can be arranged in a matrix-like manner distributed on the orientation aid. It is also possible to equip only some points of the orientation aid with marking elements, for example two or three points. This already allows the positioning of the orientation aid on the patient to be automatically evaluated based on X-ray images, MRT images and / or ultrasound images.

[0046] If the number of marker elements distributed in a matrix-like manner is large, then the surface contour of the patient's body in the region of the orientation aid can also be automatically recognized based on the X-ray image, MRT image, and / or ultrasound image by means of the marker elements. Alternatively or additionally, this recognition of the surface contour can also be carried out directly by image processing of the X-ray-based image, MRT image, and / or ultrasound image without such a matrix of marker elements. The automatic determination of the surface contour is also feasible by means of a separate detection device arranged in the region of the patient, for example by means of a camera, stereo camera, laser scanner, or similar detection instrument, where the detection device can also be used in combination with each other.

[0047] The object initially mentioned is also achieved by a kit having a plurality of elements for performing an examination and / or treatment of a patient, where the kit has at least the following elements:

[0048] a) An orientation aid on which markers defining a two-dimensional coordinate grid are arranged, where the orientation aid has a fixing surface which is designed to fix the orientation aid to the patient.

[0049] b) A computer having a computer program or at least one such computer program for a computer, where the computer program is designed to: when the computer program is executed on the computer, calculate coordinate data in the coordinate grid of the orientation aid based on

[0050] - characteristic data of the orientation aid,

[0051] - examination data of the patient, and

[0052] - at least one position on the patient selected by the user in the examination data of the patient, and output the coordinate data to the user.

[0053] In short, the kit thus has at least two elements, namely the orientation aid and the computer having the computer program or the computer program itself. The computer program can be stored on a data carrier. The kit can also include one or more additional elements, such as a needle guidance device. The orientation aid can be improved according to one or more of the variants described above.

[0054] This kit assists the doctor, for example, in the case of a biopsy, during different steps of performing an examination and / or treatment. Advantageously, the computer or the computer program assists the user, especially when looking for the desired actual position on the patient.

[0055] The computer program requires at least the characteristic data of the orientation aid and optionally the characteristic data of the position of the marking element as input, and the characteristic data is, for example, an indication of the size and division of the coordinate grid. The characteristic data of the orientation aid can, for example, be pre-stored in the computer, where the characteristic data of these different orientation aids can be stored separately when different orientation aids are applied in the computer and the selection can be displayed to the user, so that the user can select the corresponding orientation aid to be used through an input at the computer.

[0056] The computer program also requires the examination data of the patient and at least one position on the patient selected by the user in the examination data of the patient as input, and the examination data of the patient can be obtained as already described above. The user, such as a doctor, can, for example, select a position on the patient in the MRT image shown on the display, for example, the puncture site desired during a biopsy.

[0057] Then the computer program generates the coordinate data mentioned in the coordinate grid of the orientation aid as output, such as the X coordinate and the Y coordinate, and outputs the coordinate data, for example, on the display.

[0058] The object mentioned at the beginning can also be achieved by a computer program for a computer, where the computer program is set up to: when the computer program is executed on the computer, according to

[0059] - the characteristic data of the needle guidance device,

[0060] - the examination data of the patient, and

[0061] - at least one preset examination and / or treatment step to be performed by the needle guidance device, to calculate and output to the user

[0062] b1) positioning data for positioning the needle guidance device on the patient,

[0063] and / or

[0064] b2) one or more angular orientation data, which are used to set the angular orientation of the needle guidance element relative to the base element in at least one angular degree of freedom or multiple mutually independent angular degrees of freedom.

[0065] Thus, the advantages described above can also be achieved.

[0066] The object mentioned at the beginning is also achieved by a computer program for a computer, where the computer program is set up to: when the computer program is executed on the computer, according to

[0067] - the characteristic data of the orientation aid,

[0068] - The examination data of the patient, and

[0069] - At least one position on the patient selected by the user from the examination data of the patient, calculate the coordinate data in the coordinate grid of the orientation aid and display it to the user.

[0070] Thus, the advantages described above can also be achieved. The present invention also relates to a combined computer program which includes the functions of the above two computer programs. BRIEF DESCRIPTION OF THE DRAWINGS

[0071] The present invention will be described in detail below with reference to the embodiments with the aid of the drawings.

[0072] The drawings show:

[0073] Figure 1 Showing an exploded view of the needle guiding device,

[0074] Figure 2 Showing the base element,

[0075] Figure 3 、 4 Showing the holding bow,

[0076] Figure 5 Showing the clamping bow,

[0077] Figure 6 Showing the needle guiding element,

[0078] Figure 7 Showing the needle guiding element receiving part,

[0079] Figure 8 Showing the clamping mechanism,

[0080] Figure 9 Showing the holding slider,

[0081] Figure 10 Showing the operating element,

[0082] Figure 11 、 12 Showing the needle guiding device in different angular settings,

[0083] Figure 13 Showing a computer with a computer program, and

[0084] Figure 14 Showing the orientation aid, and

[0085] Figure 15 Showing another embodiment of the orientation aid, and

[0086] Figure 16 Showing another embodiment of the holding bow,

[0087] Figure 17 A very schematic diagram showing the holding bow and the clamping bow, and

[0088] Figure 18 showing the needle guiding device in different angular settings.

[0089] The reference signs used in the drawings have the following assignments:

[0090] 1 Needle guiding device

[0091] 2 Needle guiding element

[0092] 3 Operating element

[0093] 4 Holding slider

[0094] 5 Holding bow

[0095] 6 Clamping bow

[0096] 7 Base element

[0097] 8 Contact element

[0098] 9 Needle guiding element receptacle

[0099] 10 Needle-like device

[0100] 11 Tip

[0101] 20 Needle guiding body

[0102] 21 Penetration channel

[0103] 22 Connection area

[0104] 23 Operating area

[0105] 24 Recessed handle

[0106] 25 Introduction opening

[0107] 30 Handle element

[0108] 31 Cavity

[0109] 32 Internal thread

[0110] 40 Substrate

[0111] 41 Opening

[0112] 42 Second angle indicator

[0113] 50 Substrate

[0114] 51 Opening

[0115] 52 Support element

[0116] 53 Outer surface

[0117] 54 Edge region

[0118] 55 First angle indicator

[0119] 56 Second angle scale

[0120] 60 Substrate

[0121] 61 Opening

[0122] 62 Support element

[0123] 70 Substrate

[0124] 71 Needle insertion opening

[0125] 72 Position mark

[0126] 73 Mark

[0127] 74 Clamping bow

[0128] 75 Support bow

[0129] 76 Cut-out

[0130] 77 Retaining bow

[0131] 78 Cut-out

[0132] 79 First angle scale

[0133] 90 Longitudinal section

[0134] 91 Through-hole

[0135] 92 Region

[0136] 93 Support surface

[0137] 94 Threaded region

[0138] 95 Retaining section

[0139] 96 Fixing element

[0140] 100 Computer

[0141] 101 Computer program

[0142] 102 Characteristic data

[0143] 103 Inspection data

[0144] 104 Data on inspection and / or treatment steps

[0145] 105 Positioning data

[0146] 106 Angular orientation data

[0147] 200 Orientation aid

[0148] 201 Grid-like structure

[0149] 202 Marking

[0150] 203 Marking element Detailed implementation mode

[0151] In Figure 1 the needle guiding device 1 shown has a needle guiding element 2, an operating element 3, a holding slider 4, a holding bow 5, a clamping bow 6, a base element 7, a contact element 8 and a needle guiding element receiving part 9. The contact element 8 is optional. For example, it is used to fix the base element 7 on the patient's body. For this purpose, the contact element 8 can be provided with an adhesive, for example. Alternatively, the lower side of the base member 7 can be in direct contact with the patient's body. In this case, an adhesive can be provided there. Overall, the needle guiding device 1 can thus be realized by only seven components 2, 3, 4, 5, 6, 7 and 9, which can be completely or mainly made of plastic components.

[0152] The components mentioned are described below in sequence.

[0153] Figure 2 First, a perspective view of the base element 7 is shown. The base element 7 has a base body 70, which can be formed in the form of a flat, planar plate. On the lower side of the base body 70, the base element 7 can have a support surface for supporting on the patient's body. The mentioned contact element 8 can also be arranged there.

[0154] The base body 70 has a needle passage opening 71, which is used to guide a needle-like device through to the patient's body. For example, in the case of a biopsy, the puncture site of the biopsy needle can be set in the area of the needle passage opening 71. In addition, the base body 70 has a plurality of position markings 72, for example in the form of through holes. With the help of the position markings 72, the needle guiding device 1 can be accurately positioned on the patient according to a patient-related coordinate system.

[0155] Additionally, the base body 70 can have other markings 73, for example an indication of a reference position such as the lower side of the needle guiding device 1.

[0156] On both sides of the needle threading opening 71, the holding bows 77 are held projecting from the base body 70, which holding bows serve to hold and to pivotally support the bow 5 on the base element 7. The holding bows 77 have corresponding arcuate or semi-circular cutouts 78 on which the holding bow 5 can be pivotally supported. The support bows 75 project from the base body 70 adjacent to the corresponding holding bows 77. The outer, curved surface of the support bows 75 additionally serves to form a pivot bearing for the holding bow 5. The support bows 75 also have inner cutouts 76 which serve as part of the pivot bearing for the clamping bow 6. Adjacent to the support bows 75, for example on each side of the needle threading opening 71, clamping bows 74 are provided at the base body 70. The curved outer surface of the clamping bows 74 serves as the other part of the pivot bearing for the clamping bow 6. As can be seen, starting from the center of the base body 70 or from the needle threading opening 71, there are first the clamping bows 74 on each side, then the support bows 75, and finally the holding bows 77.

[0157] Furthermore, it can be seen that a first angle scale 79 can be provided on the surface of the holding bow 77 facing away from the needle guide opening 71.

[0158] Figure 3 A perspective view of the holding bow 5 is shown, Figure 4 showing a side view. The holding bow 5 has a bow-shaped base body 50 and has a slot-shaped opening 51 extending in the longitudinal direction through which the needle guide element 2 or the needle guide element receiving part 9 can be guided. The holding bow 5 has support elements 52 at its two free ends remote from each other, the curved outer contour of which matches the inner contour of the opening 78 and the outer contour of the support bow 75 facing the holding bow 77. In this way, the holding bow 5 inserted on the base element 7 between the holding bow 77 and the support bow 75 by means of its support elements 52 can pivot steplessly about the pivot axis formed in this way. A first angle indicator 55 associated with the first angle scale 79 is provided on the support element 52. By displaying the first angle indicator 55 on the first angle scale 79, the angular orientation of the needle guide element 2 relative to the base element 7 in the first angular degree of freedom can be read.

[0159] At Figure 3 and Figure 4It can additionally be seen that the holding bow 5 can have a structuring, for example a grooving, on its convexly arched outer surface 53. The outer surface 53 serves as a support and sliding surface for the holding slider 4. In order to nevertheless ensure as smooth as possible a setting of the holding slider 4 on the outer surface 53, the surface structuring or grooving can be set slightly recessed relative to the edge region 54 of the outer surface 53, such that the surface structuring or grooving only becomes effective when the clamping mechanism is fixed.

[0160] Furthermore, it can be seen that a second angle scale 56 can be provided on the holding bow 5.

[0161] Figure 5 A perspective view of the clamping bow 6 is shown. The clamping bow 6 is shaped similarly to the holding bow 5. The clamping bow 6 has a base body 60 which extends in an arched manner and has a slot-shaped opening 61 extending in the longitudinal direction. The needle guide element 2 or the needle guide element receptacle 9 can be guided through the slot-shaped opening 61. On the concave inner surface 63 of the arched base body 60, a holding surface is formed which serves as a mating support for the needle guide element receptacle 9, as will still be explained below.

[0162] Similar to the holding bow 5, the clamping bow 6 has support elements 62 at its free ends which are spaced apart from one another, by means of which the clamping bow 6 can be placed in the opening 76 of the base element 7. The support elements 62 are then located between the inner side of the support bow 75 and the outer surface of the clamping bow 74. In this way, a pivot bearing for pivoting the clamping bow 6 is formed. Here, the pivot axes of the clamping bow 6 and the holding bow 5 are identical.

[0163] Figure 6The left side of the needle guide element 2 is shown in a perspective view, the center of the needle guide element 2 is shown in a side view, and the right side of the needle guide element 2 is shown in a sectional view in the sectional plane A-A. The needle guide element 2 has a needle guide body 20, which can be configured, for example, as a hollow cylindrical body with an internal through-channel 21. The internal through-channel 21 extends completely through the needle guide body 20 along the longitudinal direction. A needle-like device, such as a biopsy needle, can be guided through the through-channel 21. The needle guide element 2 has a connection region 22 above the needle guide body 20, in which the needle guide element 2 can be coupled to the needle guide element receptacle 9. Above the connection region 22, the needle guide element 2 has a manual operation region 23, which can have, for example, one or more recessed handles 24, by means of which the grasping of the needle guide element 2 and the manual insertion or detachment from the needle guiding device are simplified. The internal through-channel 21 also extends through the connection region 22 and the manual operation region 23 along the longitudinal direction. At the upper end of the needle guide element 2, the internal through-channel 21 opens into an insertion opening 25, at which the needle-like device can be inserted into the needle guide element 2.

[0164] Figure 7 The left side of the needle guide element receptacle 9 is shown in a perspective view, the center of the needle guide element receptacle 9 is shown in a side view, and the right side of the needle guide element receptacle 9 is shown in a sectional view in the sectional plane A-A. The needle guide element receptacle 9 is used to accommodate differently configured needle guide elements 2. As a common interface leading to differently configured needle guide elements 2, the needle guide element receptacle 9 has a through-hole 91 extending along the longitudinal direction, the size of which is matched 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-hole 91 by means of the needle guide body 20. If the needle guide element 2 is completely inserted into the needle guide element receptacle 9, then the connection region 22 is located within the holding section 95 of the needle guide element receptacle 9, at which the needle guide element 2 is fixed to the needle guide element receptacle 9. The holding section 95 can be configured in the form of two holding connection plates extending along the longitudinal direction, which are at least partially arcuate on the circumferential side. At the same time, a rotational bearing is provided for the operating element 3 by means of the arcuate circumferential contour.

[0165] The holding section 95 can terminate at the free end with a fixing element 96 protruding on the circumferential side, for example, similar to a mushroom shape. Thereby, the operating element 3 can be coupled to the needle guide element receptacle 9 without being lost. The operating element 3 is simply locked onto the holding section 95 by being inserted onto it and fixed to it by the protruding fixing element 96.

[0166] Below the holding section 95, the needle guide element receiving section 9 has a threaded region 94, which is configured as a thread matching the internal thread of the operating element 3. Below the threaded region 94, there is a longitudinal section 90 of the needle guide element receiving section 9, which establishes a connection between the holding bow 5 and the clamping bow 6 in the state where the needle guiding device 1 is fully installed. Below the longitudinal section 90, the needle guide element receiving section 9 transitions into a region 92 with an increased cross-section, which forms an arcuate support surface 93 at least in one viewing direction ( Figure 7 middle). In the state where the needle guiding device 1 is fully installed, the arcuate support surface 93 contacts the concave inner surface 63 of the clamping bow 6. In this way, a part of the movable pivot bearing portion of the needle guide element 2 is formed on the holding bow 5 and the clamping bow 6.

[0167] Figure 9 A perspective view of the holding slider 4 is shown. The holding slider 4 has a base body 40, which has an opening 41. A part of the needle guide element receiving section 9, in particular the upper part of the longitudinal section 90 transitioning to the threaded region 94, can pass through the opening 41. The holding slider 4 has a support surface on the lower side, via which the holding slider 4 is guided and slides on the convexly arched outer surface 53 of the holding bow 5, or is clamped thereon when the clamping mechanism is activated. A second angle indicator 42 is also provided on the holding slider 4, which is used for angle display on the second angle scale 56 of the holding bow 5.

[0168] Figure 10 The operating element 3 is shown, which can be configured in the form of a nut with an internal thread 32. The internal thread 32 can be screwed onto the threaded region 94 of the needle guide element receiving section 9. The operating element 3 has an internal cavity 31, through which at least a part of the needle guide element 2 can pass. On the outer circumference, the operating element 3 can have a handle element 30, which is suitable for improving the transmission of the operating force, for example, a flange or other surface structuring and / or grooving on the outer circumference as shown.

[0169] Figure 11 The assembled needle guiding device 1 is shown, which has the elements already mentioned, and in addition, the needle device 10 is at least partially shown. The needle device 10 terminates with a tip 11 in the region of the through-hole 71 of the base element 7. Figure 11 The needle guiding device 1 is shown in a setting in which the angular orientation of the needle guide element 2 with respect to the two adjustable angular degrees of freedom is neutral, that is, the corresponding angle indicators 42, 55 point to the zero values of the corresponding angle scales 56, 79. In Figure 12The adjustment of the angular orientation has already been carried out such that, for example, the second angle indicator 42 points to an angle of approximately -20 degrees at the second angle scale 56. The first angle indicator 55 points to an angle of approximately +30 degrees on the first angle scale 79.

[0170] In order to set the needle guiding device 1 from one angular orientation to another, the operating element 3 only has to be rotated slightly about its longitudinal axis, for example in the counterclockwise direction, thereby slightly adjusting the threaded connection between the internal thread 32 and the threaded region 94 and thus removing the clamping caused by the clamping bow 6, which can be tensioned via the threaded connection and the needle guiding element receiving part 9. If the desired angular orientation is set, then the operating element 3 only has to be twisted in the opposite direction of rotation, thereby applying the clamping force via the threaded connections 32, 94 to the clamping bow 6 via the needle guiding element receiving part 9 and tensioning the clamping bow relative to the holding bow 5. Thereby, all pivot degrees of freedom or degrees of freedom of movement of the angular adjustment of the needle guiding device 1 are fixed.

[0171] Figure 13 A computer 100 is shown as part of a kit having a plurality of elements for performing examinations and / or treatments at a patient's body, the computer having a computer program 101. The kit can include any needle guiding device, for example a needle guiding device of the type described above and / or an orientation aid of the type described above.

[0172] In the computer 100 or in the computer program 101, the characteristic data 102 of the needle guiding device included in the kit, the examination data 103 of the patient and the data 104 of the preset examination and / or treatment steps to be performed with the aid of the needle guiding device are fed as input data. Thereby, the computer program calculates positioning data 105 for positioning the needle guiding device on the patient and angular orientation data 106 for setting the angular orientation of the needle guiding element in two mutually independent angular degrees of freedom relative to the base element. The output positioning data and angular orientation data can be shown, for example, on the display of the computer 100.

[0173] The mentioned kit can have an orientation aid 200, for example the orientation aid 200 shown in Figure 14 The orientation aid 200 has a grid-like structure 201, which can be formed by flat, flexible sub-elements. Marks 202 for defining a two-dimensional coordinate grid can be provided on the sub-elements. In addition, marking elements 203 can be arranged at a plurality of locations, for example in the form of a matrix, on the orientation aid 200. The marking elements 203 are made of a material that can be recognized in X-ray examinations, MRT examinations and / or ultrasound examinations and can accordingly also be automatically evaluated by image processing.

[0174] Figure 15Shows another embodiment of the orientation aid 200. According to Figure 14 the embodiment has a grid-like structure composed of elongated elements connected crosswise, while Figure 15 shows an embodiment in which the grid-like structure 201 is applied to a substrate formed at least substantially closed, for example, on a sheet of paper or a film. The grid-like structure 201 can be printed together with the markings 202 provided thereon. The mentioned marking elements 203 can also be present in the orientation aid 200.

[0175] If the mentioned one only has the orientation aid 200 and the computer 100 or the computer program 101, then the computer program 101 can be designed such that only the characteristic data of the orientation aid 200, the examination data of the patient, and at least one position on the patient selected by the user from the examination data of the patient are required as input data. Thereby, the computer program 101 calculates the coordinate data in the coordinate grid of the orientation aid and outputs it to the user, for example, the data E4 for the position in the fourth row and the fifth column.

[0176] Figure 16 Shows an alternative embodiment of the holding bow 5, in which, compared to the embodiments described so far, there is no special structuring on the convexly arched outer surface 53, but rather the outer surface 53 is formed with a relatively smooth surface normal for the material used.

[0177] Figure 17 Shows the holding bow 5 and the clamping bow 6 and the mutually orthogonal pivot axes X, Y in a strongly schematic manner, wherein the needle guiding device 1 can be set in different angular orientations. It can be seen that the holding bow 5 and the clamping bow 6 are each substantially bow-shaped, and the bows extend substantially parallel to each other. The holding bow 5 is located above the clamping bow 6 here. The holding bow 5 and the clamping bow 6 can pivot about the Y axis. Since there is no other bow for pivotability about the X axis in this region, there is a gap below the clamping bow 6.

[0178] Figure 18 Illustrated according to three different angular orientations A, B, C (to which the needle guiding device 1 can be set): In each setting, the needle-like device 10 always passes through the same point P through the needle guiding element 2, that is, regardless of the angle setting, the same puncture site is always produced on the patient for the needle-like device 10.

[0179] Figure 8 According to a sub-view (above) of the needle guiding device 1 and similar to Figure 17The function of the clamping mechanism is illustrated by the schematic view (below). The clamping is caused by operating element 3, that is to say, by screwing the nut with internal thread 32 relative to the threaded area 94 of the needle guide element receptacle 9. Thereby, the holding bow 5 is kept tensioned relative to the clamping bow 6, that is, by screwing, the clamping bow 6 is slightly pulled towards the holding bow 5. In this case, the shown distance M decreases. Thereby, the arcuate shape of the holding bow 5 becomes slightly flatter, while the clamping bow 6 bends more strongly. Thereby, the needle guide element 2 is initially fixed with respect to pivotability about the X-axis. In addition, the holding bow 5 and the clamping bow 6 are fixed to the base element 7 by the forces F1, F2 occurring in this transition region.

Claims

1. A needle guiding device (1) for guiding and positioning a needle-like device (10) on a patient, wherein the needle guiding device (1) has a base element (7) and a needle guiding element (2), and the needle-like device (10) can be guided along its longitudinal extension on the needle guiding element, and wherein the angular orientation of the needle guiding element (2) relative to the base element (7) can be set in two angular degrees of freedom independent of each other, and the needle guiding device has the following features: a) The needle guiding device (1) has a single operating element (3) by which the angular orientation of the needle guiding element (2) can be fixed in the two angular degrees of freedom or this fixation can be released again. b) The needle guiding device (1) has an angular scale and an angular indicator (42, 55) associated with the respective angular scale (56, 79) for each of the two adjustable angular degrees of freedom, so that the user can read the currently set angular orientation of the needle guiding element (2) in the two angular degrees of freedom according to the position of the respective angular indicator (42, 55) relative to the associated angular scale (56, 79). c) The needle guiding device (1) has a retaining bow (5) on which the needle guiding element (2) is fixed, wherein the retaining bow (5) can move relative to the base element (7) in a first angular degree of freedom of the two angular degrees of freedom, and the needle guiding element (2) can move relative to the retaining bow (5) in a second angular degree of freedom of the two angular degrees of freedom, and d) The needle guiding device (1) has a clamping bow (6) which is fixed to the base element (7) and can pivot relative to the base element (7) about the same pivot axis as the retaining bow (5).

2. The needle guiding device (1) according to claim 1, characterized in that, The needle guiding device (1) has a clamping mechanism that can be actuated by the operating element (3), wherein the angular orientation of the needle guiding 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 by means of the operating element (3).

3. The needle guiding device (1) according to any one of the above claims, characterized in that, The angular orientation of the needle guiding element (2) relative to the base element (7) can be adjusted steplessly in two angular degrees of freedom.

4. The needle guiding device (1) according to claim 1, characterized in that, A first angular scale (79) is provided on the retaining bow (5) and / or the clamping bow (6), and / or a second angular scale (56) is provided in the region of the fixing means of the retaining bow (5) on the base element (7).

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

6. The needle guiding device (1) according to claim 1 or 2, characterized in that, Each time the angular orientation of the needle guiding element in the two angular degrees of freedom is set, the needle-like device guided by the needle guiding element contacts the patient's body at the same position.

7. The needle guiding device (1) according to claim 1 or 2, characterized in that, The needle guiding device includes an arcuate retaining bow on which the needle guiding element is fixed. The holding bow can be pivotally fixed to the base element to provide a first degree of angular freedom out of two degrees of angular freedom, and the needle guiding element can move relative to the holding bow to provide a second degree of angular freedom out of two degrees of angular freedom.

8. A kit having a plurality of elements for performing an examination and / or treatment of a patient, wherein the kit at least has the following elements: a) a needle guiding device (1) for guiding and positioning a needle-like device (10) on the patient, wherein the needle guiding device (1) is the needle guiding device (1) according to any one of claims 1 - 7, b) a computer (100) having a computer program (101) or at least one such computer program (101) for the computer (100), wherein the computer program (101) is configured to: when the computer program (101) is executed on the computer (100), according to - characteristic data of the needle guiding device (1), - examination data of the patient, and - at least one preset examination and / or treatment step to be performed by means of the needle guiding device (1), calculate and output to the user b1) positioning data for positioning the needle guiding device (1) on the patient, and b2) one or more angular orientation data 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 a plurality of mutually independent degrees of angular freedom.

9. The kit according to claim 8, characterized in that, The examination data of the patient includes examination data based on X-ray examination, MRT examination, and / or ultrasound examination.

10. The kit according to claim 8 or 9, characterized in that, The kit has an orientation aid (200) as another element, a marker (202) is arranged on the orientation aid, the marker defines a two-dimensional coordinate grid, wherein the orientation aid (200) has a fixing surface which is configured to fix the orientation aid (200) on the patient.

11. The kit according to claim 10, characterized in that, The orientation aid (200) is configured as a flat flexible element.

12. The kit according to claim 10, characterized in that, The examination data of the patient includes position information of the orientation aid (200) fixed on the patient, wherein the computer program (101) is configured to additionally calculate the output of the positioning data and / or the angular orientation data according to the position information of the orientation aid (200) on the patient.

13. The kit according to claim 10, characterized in that, The orientation aid (200) has a plurality of marker elements (203), and the marker elements can be automatically detected according to an X-ray based image, an MRT image, and / or an ultrasound image.

Images