Positioning device

The alignment sight with a second indicator structure enables precise alignment of intramedullary nails by indicating orthogonal inclination in X-ray images, addressing misalignment issues and reducing radiation exposure during femoral fracture treatment.

JP2025534127AActive Publication Date: 2025-10-09I T S
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Patent Information

Application Number
JP2025523622
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Filing Date
2022-10-24
Publication Date
2025-10-09
Estimated Expiration
2042-10-24

AI Technical Summary

Technical Problem

Correct positioning of intramedullary nails in femoral fractures is challenging due to difficulties in aligning the guide wire with the femoral head, leading to misalignment and increased radiation exposure during X-ray imaging.

Method used

The alignment sight includes a second indicator structure that indicates the orthogonal inclination of the line of sight in an X-ray image, allowing for precise alignment of the target axis without requiring the bone drilling device, reducing misalignment and radiation exposure.

Benefits of technology

Facilitates quick and efficient alignment of the target axis, minimizing the risk of bone damage and reducing treatment time and radiation exposure.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention relates to a positioning device (1) for positioning and / or fixing a bone implant, in particular an intramedullary nail (2), comprising a curved handle (3) having a target guide (4) defining a target axis (Z) for guiding a bone drilling tool (5), the curved handle having a connecting element (6) for removably connecting the bone implant to the curved handle (3), and an alignment sight (7), the alignment sight having a first indicator structure (11) for indicating the trajectory of the target axis (Z) along a target sight (S2) located in a first alignment plane formed by the target axis (Z) and the first indicator structure (11) in a second X-ray image of the alignment sight (7). To provide optimal maneuverability, the alignment sight has a second indicator structure (12) that indicates an orthogonal tilt of the line of sight (S1) from the first alignment plane along the line of sight (S1) that deviates from the target line of sight (S2) in a first X-ray image of the alignment sight (7). The present invention further relates to a method for treating a bone fracture.
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Description

[Technical Field]

[0001] The present invention relates to a positioning device for a bone implant, in particular an intramedullary nail, typically for positioning and / or fixing the bone implant to treat a fracture, in particular a fracture of the proximal femur, the positioning device comprising a curved handle having a target guide, e.g. a target opening, for guiding a bone drilling device, the target guide defining a target axis, the curved handle having a connecting element for attachably connecting the bone implant to the curved handle, and an alignment aimer, the alignment aimer including a first indicator structure for indicating - by the indicator structure - the path of the target axis in a second X-ray image of the alignment aimer along a target aim line in a first alignment plane formed by the target axis and the first indicator structure.

[0002] The present invention further relates to a method for treating bone fractures, particularly proximal femoral fractures, comprising inserting an intramedullary nail into the intramedullary canal of a bone, particularly a proximal femur, using a positioning device, the intramedullary nail being particularly removably connected to a curved handle of the positioning device, the curved handle including a target guide for guiding a bone drilling device into the bone along a target axis, the curved handle including an alignment sight for aligning the target axis, the alignment sight including a first indicator structure adapted to indicate a path of the target axis in a second X-ray image of the alignment sight along a target line of sight that lies in a first alignment plane formed by the target axis and the first indicator structure. [Background technology]

[0003] Devices and methods of the above type for treating fractures of the proximal femur or femoral neck fractures are known from the prior art. To treat a femoral neck fracture, an intramedullary nail is typically introduced into the intramedullary canal of the fractured proximal femur and secured to the bone material of the femur with a connecting device, usually a bone screw. For this purpose, the intramedullary nail often has a bore extending transversely to its longitudinal axis, through which a bone screw is introduced so that one end of the bone screw protrudes into the femoral head. To insert the bone screw, a bone tunnel is generally required in the femur, leading through the bore of the intramedullary nail to the femoral head. For this purpose, a guide wire is typically first introduced into the femoral head, and then a cannulated drill is guided along the guide wire to form the bone tunnel.

[0004] The intramedullary nail is typically introduced and positioned using a positioning device that includes a curved handle to which the nail is coupled, and the surgeon then inserts and aligns the nail in the intramedullary canal of the femur by guiding the curved handle into the canal. The curved handle typically includes a targeting guide for guiding a guidewire along a target axis designated by the targeting guide. The target axis typically originates at the targeting guide and extends through a hole in the intramedullary nail.

[0005] The challenge of correct positioning typically involves correctly positioning the intramedullary nail within the femur using a positioning device and guiding the guide wire to the appropriate depth in the femoral head. For this purpose, an X-ray image is typically prepared to monitor or identify the position of the intramedullary nail and bone drilling device. To estimate the position of the guide wire relative to the femoral head in the femoral head region, it is known to equip a curved handle with an alignment sight, which often has an indicator visible in the X-ray image and is in the form of a U-shaped recess. The X-ray image can be used to indicate the path of the target axis when the line of sight of the X-ray image on which the X-ray image is taken is in a first alignment plane formed by the target axis and the indicator. Therefore, to estimate the position or path of the target axis in the X-ray image corresponding to the guide wire introduced relative to the femoral head along the target axis, the line of sight of the X-ray image must be aligned so that the line of sight, the indicator, and the target axis are in the same plane.

[0006] The corresponding adjustments to align the aiming line, indicator, and target axis line often prove to be a difficult task, especially considering that the resolution or imaging capabilities of X-rays are generally not very significant, and involve extended treatment time and significant radiation exposure to the patient or surgical staff. Because the path of the target axis line is generally not visible in X-ray images, in order to estimate the path of the target axis line based on the guide wire, it is often necessary to approach the femoral head with a guide wire along the target axis line until the guide wire is visible in the X-ray image, thereby aligning the target axis line, indicator, and aiming line of the X-ray image with each other. As a result, any misalignment of the guide wire within the bone can damage the bone material of the femur. Summary of the Invention

[0007] This is where the present invention comes in. The object of the present invention is to identify a device of the aforementioned type that allows optimal healing when implanting bone implants. A corresponding method is also identified.

[0008] According to the present invention, the first object is achieved by a device of the aforementioned type when the alignment sight includes a second indicator structure adapted to display - in a first X-ray image - the orthogonal inclination of the line of sight from the first alignment plane along a line of sight deviating from the target line of sight in order to enable alignment of the line of sight to the target line of sight.

[0009] The basis of the present invention is the idea of ​​designing an alignment sight such that the inclination of the aiming line in the X-ray image of the alignment sight relative to the first alignment plane defined by the target axis and the first indicator structure is easily discernible in the X-ray image without error.

[0010] This can be achieved particularly when the indication of the orthogonal tilt of the line of sight of the first X-ray image relative to the first alignment plane is decoupled from the first indicator structure, since the first indicator structure typically requires comparison with the path of the target axis - for example, by inserting a bone drilling device along the target axis - to detect the orthogonal tilt.

[0011] Such misalignment can be quickly and efficiently identified by providing that the alignment sight includes a second indicator structure, the function of which is to indicate that the line of sight has or reveals an orthogonal inclination from the first alignment plane in a first X-ray image of the alignment sight. The line of sight can be aligned to lie in the first alignment plane. Thus, the alignment sight, particularly the first indicator structure or the second indicator structure, represents the orientation or actual position of the target axis within the bone, or a reference point according to a bone drilling device introduced along the target axis. In particular, it is not necessary to insert a bone drilling device into the bone and use it for adjustment to detect the target axis. This allows for simple and efficient adjustment or alignment of the target axis, the first indicator structure, and the line of sight in the first X-ray image, thereby reducing the time required and / or X-ray radiation exposure. Simply performing the alignment first and then guiding the bone drilling device to or within the bone reduces the possibility of injury. This allows for optimal treatment when implanting the bone implant.

[0012] The bone drilling device may be a bone drill or a target wire, for example, a K-wire, also known as a Kirschner wire. In principle, the present invention provides that a target wire, particularly a K-wire, is first guided into the bone, thereby defining a drilling path for the target wire, and then the bone drill is guided along the path along the target wire. For this purpose, the bone drill typically includes a feed-through tube that passes through the target wire to guide the bone drill along the target wire. When the target wire is used as a guide, it is also called a guidewire. The target guide defines a target axis along which the bone drilling device can be guided with the target guide. The bone may be a portion of a bone, particularly a proximal femur, or the fracture may be a fracture of the femur, particularly a proximal femur.

[0013] The first or second X-ray image is generally prepared with an X-ray device, which is preferably adapted so that the imaging direction or line of sight of the X-ray image, along which the X-ray image is performed, can be varied and in particular controlled. It is advantageous if the tilt angle of the imaging direction or line of sight is varied and in particular controlled, preferably in two degrees of freedom. It has proven advantageous if the X-ray device is adapted as a medical C-arm. The X-ray image can be one or several X-ray images.

[0014] An X-ray image of an alignment sight, particularly a first or second X-ray image, is typically prepared with a target axis or target axis segment of the target axis indicated by a first indicator structure to indicate the path of the target axis, particularly a reference point for that path within the bone, and with a line of sight or imaging direction such that the alignment sight in the X-ray image is positioned back and forth along the line of sight. Line of sight alignment in which the line of sight has an orthogonal tilt angle with respect to the first alignment plane or does not coincide with the target line of sight is also referred to as rough alignment. The orthogonal tilt of the line of sight or imaging direction of the first X-ray image from the first alignment plane indicates the tilt of the line of sight or imaging direction perpendicular to the first alignment plane relative to the first alignment plane. This also applies to the orthogonal tilt of the line of sight with respect to the second alignment plane, as described below.

[0015] Advantageously, at least one protrusion and / or at least one recess is formed in the first indicator structure and / or the second indicator structure to form an identifiable structure, particularly an identifiable structural feature, in an X-ray image. More than one protrusion or recess may be provided, as appropriate. The protrusion or recess may be introduced into the alignment sight base body, for example, by machining, and may be part of the alignment sight base body. It is typically provided that a connecting element and a target guide for connecting the intramedullary nail to the curved handle are spaced apart from each other on the curved handle, preferably at different ends of the curved handle. It is advantageous for the connecting element and the target guide to be connected to a curved handle arm of the curved handle, with the connecting element being located at a first end and the target being located at a second end of the curved handle, typically opposite the first end. It is practical for the alignment sight to be adapted as part of, or particularly form, the first end of, the curved handle. The connecting element may in particular be arranged in a removably manner on the alignment sight, in particular on the alignment sight base body.

[0016] The second indicator structure may advantageously include a plurality of structural elements, at least partially sequentially arranged in an arrangement direction parallel to the first alignment plane or aligned parallel to the target line of sight, such that the orthogonal tilt of the line of sight from the first alignment plane in the first X-ray image is represented by or discernible from the relative positions of the structural elements. For example, by a different relative position of the structural elements compared to their intended relative positions in the second X-ray image of the alignment sight along the target line of sight. Typically, the structural elements are spaced apart from one another in a direction perpendicular to the arrangement direction. Needless to say, the structural elements are represented in the X-ray image by their respective images. Each structural element may be formed with a raised portion and / or a recessed portion, or may be formed by a portion of the raised portion and / or recessed portion. For example, structural elements adapted as protrusions or depressions, respectively, can be arranged at least partially one behind the other in the arrangement direction such that in the second X-ray image of the alignment sight, a defined lateral distance or no lateral distance is formed between the structural elements or the imaging features representing them, and such that the first X-ray image of the alignment sight shows a different lateral distance, or primarily a lateral distance, for example a gap, between the structural elements, while the aiming line is inclined orthogonally from the first alignment plane. Needless to say, the relative positions and / or distances of the structural elements in the respective X-ray images relate to the images of the structural elements, whereby they are shown in the X-ray images.

[0017] It is advantageous if the second indicator structure, in particular the structural element, is adapted to indicate the direction of the orthogonal tilt of the line of sight from the first alignment plane in the first X-ray image, so that if it is possible to distinguish in the X-ray images in which of the two directions orthogonal to the first alignment plane the orthogonal tilt is present in these or those images, this allows for efficient detection and correction of misalignment of the line of sight.

[0018] This can be conveniently implemented when the second indicator structure includes at least two first structural elements and at least one second structural element, the second structural elements spaced apart from the first structural elements in an alignment direction parallel to the first alignment plane or parallel to the target line of sight such that—when compared with a second X-ray image of the alignment sight—the first X-ray image of the alignment sight indicates a direction-dependent lateral movement of the second structural element relative to the first structural element depending on the direction of orthogonal tilt of the line of sight from the first alignment plane. The first structural elements are typically spaced apart from each other in a direction perpendicular to the alignment direction. To improve recognizability, a plurality of first and / or a plurality of second such structural elements can be provided. The first structural element and at least one second structural element can be formed with, for example, protrusions and / or recesses, and the first structural element and the second structural element are at least partially arranged sequentially in the alignment direction. The structural elements may be adapted and positioned, for example, so that a gap, also called a tilt indicator gap, exists between the first structural elements, such that the second structural element is positioned in the second X-ray image along the target aiming line that is centered on the gap, and the second structural element is shown in the first X-ray image - if the aiming line is tilted orthogonally from the first alignment plane - as being offset from the first alignment plane in the direction of the first structural element or the other structural element, depending on the direction of the orthogonal tilt of the aiming line.

[0019] It is beneficial for good detectability in X-ray images if the second indicator structure has multiple gap boundary walls, which form two tilt indicator gaps spaced apart in the first X-ray image of the alignment sight, and the direction of the orthogonal tilt can be read by comparing the gap widths of the tilt indicator gaps. It is advantageous if one or the other tilt indicator gap has a greater decrease in gap width depending on the direction of the orthogonal tilt of the line of sight from the first alignment plane. For determining target alignment, it has proven effective if the gap boundary walls in the second X-ray image of the alignment sight, or when the line of sight is located in the first alignment plane, form two tilt indicator gaps spaced apart by the same gap width. Each tilt indicator gap typically has at least one of the first structural element and at least one of the second structural element, each forming one of the gap boundary walls.

[0020] A practical implementation can be achieved when the first gap boundary wall and the second gap boundary wall each form a wall pair to form a respective tilt indicator gap in the first or second X-ray image, the second gap boundary wall being at least partially disposed downstream of the first gap boundary wall in a direction parallel to the disposition direction or the first alignment plane, and in one wall pair, the first gap boundary wall being disposed orthogonal to the first alignment plane in the first direction, while in the other wall pair, the first gap boundary wall being disposed downstream of the second gap boundary wall in a direction opposite to the first direction, so that one or the other tilt indicator gap has a greater decrease in its gap width depending on the direction of orthogonal tilt of the line of sight from the first alignment plane in the X-ray image of the alignment sight. The respective first and second gap boundary walls are typically disposed at a distance from each other in a direction orthogonal to the disposition direction and can at least partially overlap each other in this direction. In the arrangement direction, the second gap boundary walls are preferably arranged between the first gap boundary walls. It has proven effective for the second gap boundary walls of each wall pair to have a longer longitudinal extension in the arrangement direction than the first gap boundary walls. The gap boundary walls are preferably configured as rails with their respective longitudinal axes substantially parallel to the arrangement direction. Each first gap boundary wall typically represents one of the first structural elements, and each second gap boundary wall typically represents one of the second structural elements. The respective first and second gap boundary walls can be adapted to overlap or be spaced apart from each other in a direction perpendicular to the arrangement direction. The arrangement direction typically refers to a direction parallel to the first alignment plane or parallel to the target line of sight.

[0021] High readability can be achieved when the alignment sight is adapted such that the first indicator structure in the second X-ray image of the alignment sight is positioned between two tilt indicator gaps of the second indicator structure. For easy and quick reading, it is advantageous if the first indicator structure in the second X-ray image forms a notch, the notch base of which preferably indicates the path of the target axis. A structural element of the second indicator structure can be formed on a notch wall of the notch. For example, a respective one of the gap boundary walls of the tilt indicator gap can be formed on the notch wall.

[0022] Advantageously, the alignment sight includes a third indicator structure adapted to indicate, in a third X-ray image of the alignment sight, in particular in the first and / or second X-ray images of the alignment sight, the orthogonal tilt of the aiming line of the third X-ray image from the second alignment plane aligned perpendicularly to the first alignment plane, thereby aligning the aiming line of the third X-ray image to the second alignment plane. In this way, a reference point for the actual position of the segment of the target axis within the bone indicated by the first indicator structure can be defined. The third X-ray image can be the first and / or second X-ray image, so that the aiming line of the alignment sight in the first or second X-ray image corresponds accordingly to the aiming line of the third X-ray image of the alignment sight. Thus, misalignment or tilt of the respective aiming line in the first alignment plane or in a direction parallel to the first alignment plane can be detected and improved. By adjusting the line of sight of each X-ray image relative to the first and second alignment planes, the line of sight can be set in an optimal manner, thereby enabling a better estimation of the target axis or the actual position of the bone drilling device relative to the bone structure shown in the X-ray image. It is advantageous if the target line of sight also lies in the second alignment plane. In this case, the target line of sight is defined by the intersection line of the first and second alignment planes along which they intersect. It is particularly advantageous if the second alignment plane is aligned perpendicular to the target axis. As a result, if the target line of sight extends perpendicular to the target axis or if the line of sight is adjustable accordingly, the vertical distance in the X-ray image of the alignment sight along the target line of sight corresponds to the vertical distance along the target axis.

[0023] The third indicator structure preferably has a plurality of alignment structures arranged one behind the other in the arrangement direction, so that the defined alignment or superposition of the alignment structures indicates the arrangement of the aiming line of the third X-ray image in the second alignment plane. Advantageously, the third indicator structure is formed by at least one or more protrusions and / or at least one or more recesses to form a structure that can be identified in the X-ray image. The protrusions or recesses may be part of the alignment sight base body or may be introduced into the latter by machining. The first, second, and third indicator structures may be formed by common protrusions and / or recesses. Embodiments of the third indicator structure or alignment structure may be implemented in a similar manner to the first or second indicator structures or their structural elements.

[0024] Advantageously, the alignment structures are adapted to form a predetermined target overlay contour in the third X-ray image of the alignment sight when the line of sight of the third X-ray image is in the second alignment plane, with each alignment structure forming only a partial contour of the target overlay contour. Of course, it is advantageous if the target overlay contour is not formed by the second alignment plane when the line of sight is tilted in an orthogonal direction. For example, the target overlay contour can be defined to represent a depression or protrusion having a defined shape, e.g., a parabolic shape. Advantageously, one of the alignment structures is formed by a structural feature, e.g., the aforementioned notch in which the first indicator structure is formed. It is practical for each alignment structure to form a depression or protrusion in the X-ray image.

[0025] The bone implant, in particular the intramedullary nail, can typically be removably connected to the curved handle using a connecting element of the curved handle, in particular in an interlocking and / or friction-locking manner. For this, the connecting element can include a first connecting element that can be removably connected to a second connecting element of the intramedullary nail that corresponds to the shape of the first connecting element, for example by fitting together by forming an interlocking and / or friction-locking connection. The curved handle can typically be connected to the intramedullary nail in a rotationally locked manner. Typically, once the bone implant, in particular the intramedullary nail, is connected to the connecting element, it is provided that a user, typically a surgeon, guides, in particular introduces, the bone implant towards or into the bone by guiding the curved handle, and aligns the bone implant relative to the bone.

[0026] Typically, the alignment sight is formed from a radiopaque material, so that it represents structures with higher contrast in the latter's x-ray images compared to recognizable structures, particularly bone and / or tissue. It may be beneficial to form other parts of the positioning device, such as the curved handle segment on which the target guide is located or the curved handle arm of the curved handle, from a radiolucent material, so that it represents structures with lower contrast in the x-ray images compared to the alignment sight or compared to bone and / or tissue.

[0027] Advantageously, a positioning system for positioning and / or fixing an intramedullary nail in a bone, particularly a proximal femur, for treating fractures, particularly fractures of the proximal femur, is provided. The positioning system includes a positioning device and an intramedullary nail that can be introduced into the intramedullary canal of the bone. The intramedullary nail has a bore projecting transversely to the longitudinal axis of the intramedullary nail, into which a coupling device, particularly a bone screw, is received. The coupling device is introduced into the bore so that the coupling device projects beyond the bore on at least one side, particularly both sides, and the coupling device can be fixed to an end surface of a bone portion, particularly a femoral head, for example, by a screw. In this case, the positioning device can be appropriately adapted, particularly as described above. The bone drilling device can be adapted as a bone drill or a guide wire, particularly a K-wire. Advantageously, the bone drilling device and / or the coupling device are components of the positioning system. The intramedullary nail can typically be removably connected to a connecting element of the positioning device, particularly as described above, so that the intramedullary nail can be introduced into the intramedullary canal of the bone using the positioning device. The intramedullary nail is typically adapted so that when the intramedullary nail is connected to the connecting element, the hole axis of the hole is aligned with the target axis, which typically defines the path along which the bone screw will be introduced into the intramedullary nail.

[0028] By preparing an X-ray image of the alignment sight, in particular according to said second X-ray image, an orthogonal inclination of the aiming line from the alignment plane is identifiable or indicated by a second indicator structure on the X-ray image. In this way, the aiming line of the X-ray image and the first alignment plane can be aligned with each other, so that when the intramedullary nail is particularly removably connected to the connecting element, a bone drilling device such as a target wire, in particular a K-wire, can be guided by the target guide of the positioning device, in particular along the target axis through the hole, and said bone drilling device has a path indicated by the first indicator structure on the X-ray image.

[0029] It is practical for the target guide to include a guide device and a drill device guide, the drill device guide including a drill device tube for guiding the bone drill device, and the drill device guide having an interlocking, particularly attachable, connection with the guide device, so that the drill device guide can be movably guided along the target axis relative to the guide device to guide the drill device tube to the bone surface of the bone or the intramedullary nail when the intramedullary nail is introduced into the bone. In this way, the bone drill device is protected by the drill device guide. The diameter of the drill device tube is usually adapted according to the diameter of the bone drill device. Depending on the bone drill device used, different drill device guides having drill device tube diameters adapted to the diameter of the bone drill device can be used as appropriate. When the drill device guide of the drill device tube is connected to the guide device, the drill device tube is typically arranged along the path of the longitudinal axis of the drill device guide, or the longitudinal axis of the drill device tube is aligned along the target axis to guide the drill device along the target axis. The drill device tube can be adapted, for example, as a drill hole. The drilling device guide generally includes a rod-shaped segment, which forms the end of the drilling device guide facing the intramedullary nail when guided by the guide device, or is particularly substantially rod-shaped. The guide device and the drilling device guide are usually adapted to bridge the path section between the guide device and the intramedullary nail when the drilling device guide is in its deployed position projecting toward the intramedullary nail, thereby protecting and guiding the bone drilling device along said path section. It is advantageous if the drilling device guide can be guided substantially to the intramedullary nail, and the remaining distance to the intramedullary nail can vary depending on the thickness of the respective bone. It is usually provided that the drilling device guide is pushed through the body tissue surrounding the bone to close to the bone surface of the bone or close to the intramedullary nail. In this way, the bone drilling device is protected by the drilling device guide while positioned in the drilling device tube close to the intramedullary nail or bone, so that the bone drilling device can then be further inserted into the bone. The guide device can be formed with a guide tube into which the drilling device guide can be introduced in an interlocking manner.The guide tube generally defines a guide tube axis that coincides with the target axis and along which the drilling equipment guide may be movably guided.

[0030] Advantageously, the targeting guide includes a tissue protection jacket that can move relative to the guide device and thereby at least partially encase the drilling device guide in the deployed position of the drilling device guide, which is guided by the guide device toward the bone or the intramedullary nail to separate the drilling device guide from the body part tissue surrounding the bone. This makes it possible to reduce, and in particular prevent, any damage to the body part tissue during the movement of the drilling device guide. The tissue protection jacket can suitably be formed with an enclosing surface in at least one section, which at least partially, preferably mostly, and in particular completely encases the drilling device guide in the circumferential direction of the drilling device guide when the drilling device guide is introduced into the drilling device guide tube. This applies in particular to the end element of the tissue protection jacket facing the intramedullary nail. Advantageously, the tissue protection jacket is adapted to substantially encase the drilling device guide in its deployed position over a large portion, in particular over the entire longitudinal extension, of the drilling device guide between the deployed position and the guide device. A high degree of practicality can be achieved if the tissue protective jacket can be connected to the guide device in an interlocking manner, particularly in an attachable manner, so that the tissue protective jacket can be moved relative to the guide device along a target axis to guide the tissue protective jacket toward the bone surface of the bone or the intramedullary nail when the intramedullary nail is introduced into the bone. It is advantageously provided that the tissue protective jacket includes a drilling device guide tube for guiding the drilling device guide, and that the drilling device guide can be connected to the drilling device guide tube in an interlocking manner, particularly in an attachable manner, so that the drilling device guide can be movably guided along the target axis relative to the tissue protective jacket. As a result, the tissue protective jacket can be guided along the target axis through the tissue of a body part close to the bone, and then the drilling device guide can be guided to the deployed position. It is practical if the tissue protective jacket can be introduced into the guide tube of the guide device in an interlocking manner.The tissue protection jacket can then be introduced into the guide tube of the guide device in an interlocking manner, and the tissue protection jacket can be introduced close to the intramedullary nail or bone; and then the drilling device guide can then be introduced into the drilling device guide of the tissue protection jacket in an interlocking manner, and the drilling device guide can be guided close to the intramedullary nail while still at least partially enclosed in the tissue protection jacket.

[0031] It is advantageous if the guide device includes multiple guide tubes, each adapted for a movably guiding connection with a drilling device guide or a tissue protection jacket, and preferably different guide tubes have different target axes or define different guide tube axes along which the bone drilling device is guided. Accordingly, the guide device includes at least one or more additional guide tubes, each defining a further guide tube axis or a further target axis, thereby providing for a particularly removably connected drilling device guide and / or tissue protection jacket, which are movably guided along the further guide tube axis, to the guide device, in particular in the manner described above. A drilling device, such as a bone drill, or a guide wire, in particular a K-wire, can then be guided by the drilling device guide along the further guide tube axis in the manner described above. The intramedullary nail may optionally include at least one or more further holes, the respective hole axes of which respectively coincide with one of the guide tube axes. A further coupling element, such as a bone screw, may be introduced into each further hole and may be provided to protrude beyond the respective further hole on at least one or both sides to secure the intramedullary nail to the bone.

[0032] It is advantageous if the target guide, in particular the guide device, is removably connected to the curved handle arm of the curved handle, whereby the target guide or guide device is attached from the curved handle arm of the curved handle. A connecting device can be provided that allows the target guide, in particular the guide device, and the curved handle arm to be removably connected to one another, in particular in an interlocking and / or friction-locking manner. This allows the target guide, in particular the guide device, to be connected to the curved handle only after the intramedullary nail has been introduced into the bone. This simplifies handling during the procedure. It is practical if the alignment sight is removably connected to the curved handle arm by a connecting adapter, in particular in an interlocking and / or friction-locking manner.

[0033] A further object is achieved by a method of the aforementioned type when a first X-ray image of an alignment sight of the curved handle is prepared along the line of sight, and then an adjustment of the line of sight to the first alignment plane is made based on a second indicator structure of the alignment sight, the indicator structure being adapted to indicate an orthogonal tilt of the line of sight from the first alignment plane in the X-ray image of the alignment sight. To perform this method, it is generally provided to use a positioning device or a positioning system as described herein. As described above, the adjustment or alignment of the target axis, the first indicator structure, and the line of sight of the X-ray image can be performed simply and practically, thereby reducing the time required and / or X-ray radiation exposure.

[0034] The target axis is typically aligned transversely to the longitudinal axis of the nail, preferably to split the nail or coincide with the axis of the hole in the nail, particularly as discussed above. For treating the proximal femur, the target axis is typically aligned with the longitudinal axis of the nail at an angle where the longitudinal axis of the femur is aligned with the longitudinal axis of the femoral neck, typically between 110° and 140°. When the bone is a femur, the target line of sight of the x-ray typically corresponds to the lateral-medial aspect of the body of the femur or part of the femur.

[0035] It is advantageous if the bone drilling device, in particular the K-wire, is guided into the bone along the target axis via the target guide in the curved handle, and the line of sight is adjusted based on the second indicator structure for comparison with the first indicator structure before and / or after the bone drilling device is visible in the first X-ray image, so that optimal adjustment of the line of sight can be achieved before and / or after the bone drilling device is visible in the X-ray image.

[0036] Typically, an intramedullary nail includes a hole extending transversely to the longitudinal axis of the nail for receiving a connecting device, particularly a bone screw, and a bone drilling device, particularly a K-wire, is guided through the hole along the target axis via a target guide. The hole typically has a hole axis corresponding to the target axis. The bone drilling device can be a bone drill or a target wire, particularly a K-wire. The connecting device can be used to fix the intramedullary nail to the bone or to connect bone material of the bone to the intramedullary nail. For this purpose, the connecting device can be introduced into the hole of the intramedullary nail so that it protrudes beyond the hole on at least one side, particularly both sides. The connecting device is typically fixed to the bone material of the bone at at least one end of the connecting device, typically the end that leads into the bone in the insertion direction of the connecting direction. For this purpose, the end can have a thread.

[0037] In principle, a bone tunnel is introduced into the bone along the target axis with a bone drilling device, usually through the hole of the intramedullary nail; thereafter, a coupling device is then introduced into the hole along the bone tunnel. If the bone is a proximal femur, the bone tunnel generally extends along the target axis to the femoral head, and the coupling device is preferably introduced into the hole so that one end of the coupling device protrudes into the femoral head or is fixed to the femoral head with, for example, a screw.

[0038] It is advantageous if a target wire, particularly a bone drilling device adapted as a K-wire, having a smaller diameter than the connecting device is first introduced into the bone along the target axis, particularly in the manner described above, and a bone hole is then introduced into the bone with the bone drill, with the target wire acting as a guide. The connecting device can then be introduced into the hole, typically through the bone hole, so that the connecting device extends beyond the hole on at least one or both sides. In this case, the second bone drilling device or the bone drill and / or the connecting device are typically adapted to allow a cannula to be inserted to guide them along the target wire. For this purpose, the bone drilling device or the connecting device can include a feed-through tube. If the bone is the proximal femur, the connecting device is typically secured to the femoral head at its end. The guide wire is typically removed after the connecting device has been introduced into the hole of the intramedullary nail, particularly the femoral head.

[0039] To avoid rotation of the femoral head when drilling the bone hole, in particular the second bone hole, and / or when introducing the coupling device into the hole of the intramedullary nail, it may be advantageous to introduce an additional guide wire, in particular a K-wire, with an offset axis into the femoral head, so that the expanded guide wire can extend along an additional target axis, preferably through the additional hole of the intramedullary nail, into the femoral head. The additional guide wire can be suitably introduced into the femoral head by means of the guide device, for example via an additional guide tube of the guide device.

[0040] The first x-ray image of the alignment sight typically refers to an x-ray image of the alignment sight along the line of sight while tilting the line of sight perpendicularly from the first alignment plane. The second x-ray image of the alignment sight typically refers to an x-ray image of the alignment sight along the line of sight located in the first alignment plane.

[0041] Further features, advantages, and benefits are demonstrated in the exemplary embodiments described below. [Brief explanation of the drawings]

[0042] [Figure 1] FIG. 1 shows a positioning device for an intramedullary nail. [Figure 2] 10A-10C show alignment sights of a positioning device from different lines of sight. [Figure 3] 10A-10C show alignment sights of a positioning device from different lines of sight. [Figure 4] FIG. 10 shows an x-ray image of a proximal femur along a line of sight that is in a plane with the target axis and first indicator structure. [Figure 5] FIG. 5 shows a further X-ray image according to FIG. 4 in which a K-wire has been introduced into the bone along the target axis. [Figure 6] 4 is a diagram of the alignment sight of FIGS. 2 and 3, showing an oblique plan view of the indicator structure of the alignment sight; FIG. [Figure 7] FIG. 10 is a diagram showing a guide device of a target guide. [Figure 8] FIG. 10 shows a tissue protection jacket of the targeting guide. [Figure 9] FIG. 10 shows a drilling device guide for the target guide. DETAILED DESCRIPTION OF THE INVENTION

[0043] FIG. 1 shows a schematic diagram of an intramedullary nail positioning device 1 for positioning and fixing an intramedullary nail 2 in the intramedullary canal of a bone, particularly a proximal femur. Its purpose is typically to treat a bone fracture, usually a femoral neck fracture in the case of the proximal femur. The positioning device includes a curved handle 3 having a target guide 4 for guiding a bone drilling device 5, e.g., a K-wire, along a target axis Z, a connecting element for connecting the intramedullary nail 2 to the curved handle 3 in a rotationally locked manner, and an alignment sight 7 for displaying the path of the target axis Z on an X-ray image for aligning the target axis Z when the intramedullary nail 2 is introduced into the bone with the alignment sight 7. The connecting element 6 and the target guide 4 are arranged on a curved handle arm 9 of the curved handle 3, typically at different ends of the curved handle arm 9, spaced apart from each other.

[0044] The intramedullary nail 2 includes a hole 10 extending transversely to its longitudinal axis to accommodate a connecting device, such as a bone screw, for securing the intramedullary nail 2 by introducing the connecting device into the hole 10 so that the connecting device protrudes beyond the hole 10 in the bone. The connecting device is typically fixed to the end face of a bone portion, and in the case of the proximal femur, is typically fixed to the femoral head. When the intramedullary nail 2 is connected to the connecting element 6, the axis of the hole 10 and the target axis Z coincide so that the target axis Z protrudes through the hole 10, as shown in FIG. 1 . Typically, a bone drilling device 5 adapted as a K-wire is first guided through the hole 10 along the target axis Z using the target guide 4, and then the bone drill is introduced into the bone along the target axis Z of the hole 10 in the bone tunnel, with the K-wire acting as a guide for the bone drill. The connecting device can then be introduced through the bone tunnel and into the medullary canal hole 10.

[0045] Alignment of the target axis Z within the bone to guide the K-wire or coupling device to the appropriate depth and position within the bone is performed while preparing an X-ray image of the alignment aimer 7, such that the first indicator structure 11 of the alignment aimer 7 shown in the X-ray image represents a reference point for the path of the target axis Z within the bone. The X-ray image is typically performed by an X-ray device 13, the X-ray image having a crosshair S1 controllably variable. The first indicator structure 11 is adapted to display the path of the target axis Z on the X-ray image of the alignment aimer 7 along a target crosshair S2 that lies in a first alignment plane formed by the target axis Z and the first indicator structure 11. This is shown in FIG. 2, which shows the first alignment plane extending through the target axis Z at a right angle to the plane of the drawing. In order to be able to align the line of sight S1 of the X-ray image of the alignment sight 7 according to the target line of sight S2, i.e. to be able to detect misalignment of the line of sight S1, the invention provides that the alignment sight 7 includes a second indicator structure 12 shaped to indicate in the X-ray image the orthogonal inclination of the line of sight S1 from the first alignment plane. This is shown in Figures 2 and 3.

[0046] 2 and 3 show schematic views of a positioning device, particularly the alignment sight 7 of the positioning device of FIG. 1 . In FIG. 2, the alignment sight 7 is shown along the first alignment plane from a perspective where the alignment sight 7 can be seen in its entirety, and in FIG. 3, the alignment sight 7 is shown from a perspective where the first alignment plane is tilted orthogonally to see the alignment sight 7. The first indicator structure 11 is recessed, so that an image of the first indicator structure 11, similar to FIG. 2, on an X-ray along the target sight line S2 shows a notch, particularly a U-shaped or V-shaped notch, which indicates the path of the target axis line Z together with the notch. The path of the target axis line Z is particularly marked by the base of the notch. For accurate indication, it is advantageous if the recesses or notches have a tapered cross section along their depth direction. The indicator structure is preferably formed as a protrusion or recess.

[0047] The second indicator structure 12 is formed with a plurality of gap boundary walls spaced apart from one another, and the second indicator structure 12 is particularly embodied as a rail that is substantially parallel to and perpendicular to the longitudinal axis of the first alignment plane or parallel to the target line of sight S1, so that the gap boundary walls in an X-ray image of the alignment sight 7 along the target line of sight S2 form two tilt indicator gaps 14 spaced apart from one another, and the first gap boundary wall 15 and the second gap boundary wall 16 each form a wall pair to form a respective tilt indicator gap 14, and each second gap boundary The walls 16 are disposed at least partially downstream of the first gap boundary wall 15 in a direction parallel to the first alignment plane, and in one wall pair, the first gap boundary wall 15 is disposed downstream of the second gap boundary wall 16 in a first direction perpendicular to the first alignment plane, while in the other wall pair, the first gap boundary wall 15 is disposed downstream of the second gap boundary wall 16 in a direction opposite to the first direction, so that one or the other tilt indicator gap 14 exhibits a greater decrease in gap width depending on the direction of orthogonal tilt of the sighting line S1 from the first alignment plane in an X-ray image of the alignment sight 7. The arrangement of the gap boundary walls is particularly apparent from Figures 2, 3, and 6, which shows a schematic diagram of the alignment sight with an oblique plan view of the gap boundary walls. Due to this arrangement of the gap boundary walls, the direction of orthogonal tilt of the line of sight S1 from the target line of sight S2 can be efficiently and easily read in an X-ray image. It is advantageous for the tilt indicator gaps 14 to have equally large gap widths in an X-ray image along the target line of sight S2. A particularly sensitive indication of orthogonal tilt can be achieved by disposing the first indicator structure 11 between the tilt indicator gaps 14. As can be seen in FIGS. 2 and 3 , the tilt indicator gaps 14 in FIG. 2 have equal gap widths, while in FIG. 3 , one of the tilt indicator gaps 14 has a smaller gap width than the other tilt indicator gap 14 due to the orthogonal tilt, depending on the respective direction of the orthogonal tilt of the first alignment plane.

[0048] It may be practical for the alignment sight 7 to include a third indicator structure 17, thereby displaying in an X-ray image of the alignment sight 7 the orthogonal tilt of the line of sight S1 from a second alignment plane aligned perpendicularly to the first alignment plane defined by the target axis Z and the first indicator structure 11. As a result, the line of sight S1 may also be substantially aligned with the second alignment plane. The third indicator structure 17 may be formed with two alignment structures 25, preferably configured as recesses and arranged one behind the other in a direction parallel to the first alignment plane, such that the defined overlap of the recesses in the X-ray image forms a target overlap contour. As can be seen from FIGS. 2 and 3 , this can be implemented by implementing one of the recesses of the third indicator structure 17 with the recess of the first indicator structure 11 and arranging a further recess behind the former in the direction of the target line of sight S2.

[0049] FIG. 4 shows an X-ray image of the alignment sight 7 according to FIG. 2 or 3 as part of an exemplary treatment for a proximal femoral fracture. In particular, the alignment sight 7 is part of the positioning device 1 according to the embodiment shown in FIG. 1. The X-ray image shows the alignment of the target axis Z on the femoral head for introducing a K-wire into the femoral head along the target axis Z after the target axis Z is aligned. For illustrative purposes, the target axis Z is depicted as a dashed line in the X-ray image. The X-ray image's aim line S1 is aligned with the first alignment plane so that the inclined indicator gaps 14 have substantially equal gap widths; therefore, the notch in the first indicator structure 11 shows the path of the target axis Z. FIG. 5 shows a further X-ray image of the alignment sight 7 according to FIG. 4, in which a K-wire has been introduced into the femoral head along the target axis Z. The longitudinal axis of the K-wire extends following the path indicated by the notch in the first indicator structure 11 .

[0050] FIG. 6 shows a schematic diagram of the alignment sight 7 of FIGS. 2 and 3 , illustrating an oblique plan view of the first indicator structure 11 and the second indicator structure 12 of the alignment sight 7. As described above, one of the first gap boundary walls 15 and one of the second gap boundary walls 16 form one of the wall pairs to form one of the oblique indicator gaps 14 in an X-ray image. The first gap boundary wall 15 and the second gap boundary wall 16 of each wall pair are spaced apart from each other in a direction perpendicular to the target sight line S2 and may overlap each other. The recessed portion of the first indicator structure 11 is located between the two wall pairs. The central circular structure shown in FIG. 6 represents a hole in the alignment sight body that is incorporated during manufacturing of the alignment sight 7, thereby mounting the indicator structure to the alignment sight body of the alignment sight 7.

[0051] To guide the bone drilling device 5 through the targeting guide 4, the targeting guide 4 advantageously includes a guide device 18 and a drilling device guide 19, the guide device 18 being adapted to guide the drilling device guide 19, and the drilling device guide 19 being adapted to guide the bone drilling device 5 (as shown in FIG. 1 ). The guide device 18 is typically removably connected to the curved handle arm 9. The drilling device guide 19 is preferably removably disposed on the guide device 18. The drilling device guide 19 can be stabilized on the drilling device guide 19 to guide the bone drilling device 5 toward the bone. The drilling device guide 19 is typically guided through and toward the bone through body part tissue surrounding the bone. To separate the drilling device guide 19 and the body part tissue for protection, the targeting guide 4 advantageously includes a tissue protection jacket 20 at least partially enclosing the drilling device guide 19. FIG. 7 shows a schematic diagram of the guide device 18, FIG. 8 shows a schematic diagram of the tissue protective jacket 20, and FIG. 9 shows a schematic diagram of the targeting guide 4, particularly the drill tool guide 19 of the targeting guide 4 of FIG. 1. The guide device 18 includes a guide tube 22 for introducing the drill tool guide 19 and preferably the tissue protective jacket 20 into the guide tube 22 so that the guide tube axis of the guide tube 22 coincides with the target axis Z, as can be seen in FIG. 1; therefore, the drill tool guide 19 or the tissue protective jacket 20 can be moved along the target axis Z. The generally substantially rod-shaped drill tool guide 19 includes a drill tool tube 24 that can guide a bone drill tool 5, particularly a K-wire. The tissue protective jacket 20 includes a drill tool guide tube 23 for introducing the drill tool guide 19 into the drill tool guide tube 23 so that the drill tool guide 19 can be moved along the drill tool guide tube 23 in an interlocking manner. The tissue protective jacket 20 is adapted to at least partially encase the drilling tool guide 19 .The present invention conveniently provides that the tissue protection jacket 20 can be introduced into the guide tube 22, and then the tissue protection jacket 20 can be deployed by the guide tube 22 in a guided manner relative to the guide tube 22 toward the intramedullary nail 2 to guide the tissue protection jacket 20 toward the intramedullary nail 2 or the bone. This is shown in FIG. 1 . Next, the drill tool guide 19 can be guided along the drill tool guide tube 23 toward the intramedullary nail 2 or the bone. The invention in this case provides that the longitudinal axis of the drill tool tube 24 coincides with the target axis Z. Next, a drill tool, such as a K-wire, can be introduced into the bone through the drill tool tube 24 of the drill tool guide 19, which is guided along the target axis Z. When the tissue protection jacket 20 is not used, the drill tool guide 19 can be introduced into the guide tube 22, and then the drill tool guide 19 can be deployed by the guide tube 22 in a guided manner relative to the guide tube 22 toward the intramedullary nail 2 to guide the drill tool tube 24 toward the intramedullary nail 2. For this purpose, the cross section of the drilling tool guide 19 can be adapted to correspond to the shape of the cross section of the guide tube 22 .

[0052] Therefore, it is advantageous if the positioning device 1 comprises an alignment sight 7 having a first indicator structure 11 for indicating the path of the target axis line Z along the target sight line S2 in an X-ray image of the alignment sight 7, the first indicator structure 11 and the target axis line Z defining a first alignment plane, and the alignment sight 7 includes a second indicator structure 12 adapted to indicate the orthogonal inclination of the sight line S1 from the first alignment plane along the sight line S1 in the X-ray image of the alignment sight 7. As a result, the sight line S1 in the X-ray image of the alignment sight 7 can be aligned according to the first alignment plane or the target sight line S2. When the intramedullary nail 2 is introduced into the intramedullary canal of the bone by the positioning device, the first indicator structure shown in the X-ray image of the alignment sight 7 having the sight line S1 aligned with the target sight line S2 represents a reference point for the path of the target axis line Z within the bone. If the second indicator structure 12 is formed with two tilt indicator gaps 14, preferably embodied by protrusions or recesses, and the direction of the orthogonal tilt from the first alignment plane can be read on the tilt indicator gaps 14, a compact structure can be achieved and a simple and efficient determination of the orthogonal tilt or alignment of the line of sight S1 of the X-ray image can be performed.

Claims

1. A positioning device (1) for positioning a bone implant, in particular an intramedullary nail (2), for positioning and / or fixing said bone implant, typically for treating a fracture, in particular a fracture of the proximal femur, said positioning device (1) comprising a curved handle (3) having a target guide (4), e.g. a target opening, for guiding a bone drilling device (5), said target guide (4) defining a target axis (Z), said curved handle (3) having a connecting element (6) for removably connecting said bone implant to said curved handle (3), and an alignment sight (7), said alignment sight (7) including a first indicator structure (11) whereby said alignment a positioning device (1) including a second indicator structure (12) adapted to display a path of the target axis (Z) by the first indicator structure (11) along a target line of sight (S2) located in a first alignment plane formed by the target axis (Z) and the first indicator structure (11) in a second X-ray image of the alignment sight (7), and to indicate an orthogonal tilt of the line of sight (S1) from the first alignment plane along the line of sight (S1) that deviates from the target line of sight (S2) in the first X-ray image of the alignment sight (7), thereby enabling the alignment sight (7) to adjust the line of sight (S1) to the target line of sight (S2).

2. 2. The positioning device (1) of claim 1, wherein the first indicator structure (11) and / or the second indicator structure (12) are formed with at least one protrusion and / or at least one recess to form a structure that can be identified in an X-ray image.

3. 3. The positioning device (1) of claim 1 or 2, wherein the second indicator structure (12) is adapted to indicate, in the first X-ray image, a direction of the orthogonal tilt of the line of sight (S1) from the first alignment plane.

4. The positioning device (1) according to any one of claims 1 to 3, wherein the second indicator structure (12) is formed with a plurality of gap boundary walls, such that the gap boundary walls form two tilt indicator gaps (14) spaced apart from each other in the first X-ray image of the alignment sight (7), and the direction of the orthogonal tilt can be read by comparing the gap widths of the tilt indicator gaps (14).

5. 5. The positioning device (1) of claim 4, wherein each tilt indicator gap (14) is formed in the X-ray image by a first gap boundary wall (15) and a second gap boundary wall (16) that form a wall pair, the second gap boundary wall (16) being at least partially disposed downstream of the first gap boundary wall (15) in a direction parallel to the first alignment plane, and in one of the wall pairs, the first gap boundary wall (15) is disposed downstream of the second gap boundary wall (16) in a first direction perpendicular to the first alignment plane, and in the other of the wall pairs, in a second direction opposite to the first direction, so that the one or other tilt indicator gap (14) has a greater decrease in gap width depending on the direction of the orthogonal tilt of the aiming line (S1) from the first alignment plane in the X-ray image of the alignment sight (7).

6. 6. The positioning device (1) according to claim 4 or 5, wherein the alignment sight (7) is adapted so that the first indicator structure (11) in the second X-ray image is positioned between the two tilt indicator gaps (14), and the first indicator structure (11) is preferably implemented by a notch.

7. 7. The positioning device (1) according to claim 1, wherein the alignment sight (7) comprises a third indicator structure (17) adapted to indicate, in a third X-ray image of the alignment sight (7), in particular in the first and / or second X-ray images of the alignment sight (7), an orthogonal tilt of the line of sight of the third X-ray image from a second alignment plane aligned perpendicularly to the first alignment plane, thereby aligning the line of sight of the third X-ray image to the second alignment plane.

8. 8. The positioning device (1) of claim 7, wherein the third indicator structure (17) is formed with a plurality of alignment structures (25) arranged one behind the other in a direction parallel to the target line of sight (S2), so that a defined alignment or superposition of the alignment structures (25) indicates the positioning of the line of sight of the third X-ray image within the second alignment plane.

9. 10. A positioning system for positioning and / or fixing an intramedullary nail (2) in a bone, in particular a proximal femur, for treating fractures, in particular fractures of the proximal femur, the positioning system comprising a positioning device (1) and an intramedullary nail (2) that can be introduced into the intramedullary canal of the bone, the intramedullary nail (2) having a hole (10) projecting transversely to a longitudinal axis of the intramedullary nail (2) and into which a coupling device, in particular a bone screw, is received, the coupling device being introduced into the hole (10) so that it projects beyond the hole (10) on at least one side, in particular both sides, the coupling device being fixable to an end face of a bone part, in particular a femoral head, the positioning device (1) being adapted as claimed in any one of claims 1 to 8.

10. 10. The positioning system according to claim 9, wherein the target guide (4) comprises a guide device (18) and a drill device guide (19), the drill device guide (19) comprising a drill device tube (24) for guiding the bone drill device (5), the drill device guide (19) being connectable to the guide device (18) in an interlocking manner, in particular removably, so that the drill device guide (19) can be movably guided relative to the guide device (18) along the target axis to guide the drill device tube (24) to the bone surface of the bone or the intramedullary nail when the intramedullary nail is introduced into the bone.

11. 11. The positioning system of claim 10, wherein the target guide (4) includes a tissue protective jacket (20) that can move relative to the guide device (18) to at least partially encase the drilling device guide (19) in a deployed position, and the drilling device guide (19) is guided toward a bone or an intramedullary nail (2), thereby isolating the drilling device guide (19) from the body part tissue surrounding the bone.

12. A method for treating a bone fracture, in particular a proximal femoral fracture, comprising using a positioning device (1), in particular a positioning device (1) according to any one of claims 1 to 8, to introduce an intramedullary nail (2) into the intramedullary canal of a bone, in particular a proximal femur, the intramedullary nail (2) being particularly removably connected to a curved handle (3) of the positioning device (1), the curved handle (3) comprising a target guide (4) for guiding a bone drilling tool (5) into the bone along a target axis (Z), the curved handle comprising an alignment sight (7) for aligning the target axis (Z), the alignment sight (7) positioning a first indicator structure (11) in a second X-ray image of the alignment sight (7) in a direction perpendicular to the axis of the bone, the first indicator structure (11) being in a position parallel to the axis of the bone, the second ... a first indicator structure (12) of the alignment sight (7) adapted to indicate an orthogonal tilt of the target axis (Z) from the first alignment plane, the target axis (Z) being positioned along a target line of sight (S2) located in a first alignment plane formed by the target axis (Z) and the first indicator structure (11); a first X-ray image of the alignment sight (7) of the curved handle (3) is prepared along the line of sight (S1), and the line of sight (S1) is adjusted relative to the first alignment plane based on a second indicator structure (12) of the alignment sight (7), the second indicator structure (12) being adapted to indicate an orthogonal tilt of the line of sight (S1) from the first alignment plane in the X-ray image of the alignment sight (7).

13. 13. The method of claim 12, wherein a bone drilling device (5), in particular a K-wire, is guided into the bone along the target axis (Z) using the target guide (4) of the curved handle (3), and the line of sight (S1) is adjusted based on the second indicator structure (12) before and / or after the bone drilling device (5) is visible in the first X-ray image for comparison with the first indicator structure (11).

14. 14. The method according to claim 12 or 13, wherein the intramedullary nail (2) comprises a hole (10) extending transversely to the longitudinal axis of the intramedullary nail (2) for accommodating a coupling device, in particular a bone screw, and the bone drilling device (5), in particular a K-wire, is guided through the hole (10) along the target axis (Z) by the target guide (4).

15. 15. The method according to claim 14, wherein a bone drilling device adapted as a target wire, in particular a K-wire, having a smaller diameter than the connecting device, is guided in a first step through the hole (10) along the target axis (Z), after which a bone tunnel is introduced into the bone along the target axis (Z) by a bone drill, the target wire acting as a guide, after which the connecting device is introduced into the hole (10) via the bone tunnel.

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