Positioning device
Patent Information
- Application Number
- EP2022797634
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2022-10-24
- Publication Date
- 2025-09-03
AI Technical Summary
Current methods for positioning intramedullary nails in treating proximal femur fractures are challenging due to difficulties in aligning the guide wire correctly, often requiring multiple X-rays and resulting in radiation exposure and potential bone damage, as the alignment of the X-ray line of sight, indicator, and target axis can be complex and prone to misalignment.
The positioning device incorporates an alignment visor with a second indicator structure that decouples the display of orthogonal tilting of the X-ray line of sight from the first alignment plane, allowing for easy recognition and correction of misalignment, thereby simplifying the alignment process without the need for inserting the bone drill initially.
This approach reduces the time and radiation exposure required for alignment, minimizing the risk of bone damage by enabling precise alignment of the target axis and X-ray line of sight, facilitating more efficient and accurate implantation of the intramedullary nail.
Smart Images

Figure 1.1
Abstract
Description
[0001] Positioning device
[0002] The invention relates to a positioning device for a bone implant, in particular an intramedullary nail, for positioning and / or fixing the bone implant, typically for treating a bone fracture, in particular a fracture of a proximal femur, wherein the positioning device has a handle with a target guide, such as a target hole, for guiding a bone drilling device, wherein the target guide defines a target axis, and wherein the handle has a connecting element for detachably connecting the bone implant to the handle, and an alignment sight, wherein the alignment sight has a first indicator structure for indicating, with the first indicator structure, a course of the target axis in a second x-ray image of the alignment sight along a desired line of sight which lies in a first alignment plane formed by the target axis and the first indicator structure.
[0003] The invention further relates to a method for treating a bone fracture, in particular a proximal femur fracture, wherein an intramedullary nail is inserted into an intramedullary canal of a bone, in particular a proximal femur, using a positioning device, wherein the intramedullary nail is connected, in particular detachably, to a handle of the positioning device, wherein the handle has a target guide for guiding a bone drilling device into the bone along a target axis, wherein the handle has an alignment sight for aligning the target axis, wherein the alignment sight has a first indicator structure which is designed to display a course of the target axis in a second x-ray image of the alignment sight along a desired line of sight which lies in a first alignment plane formed by the target axis and the first indicator structure.
[0004] Devices and methods of the type mentioned above for treating a fracture of the proximal femur or a femoral neck fracture are known from the prior art. Typically, to treat a femoral neck fracture, an intramedullary nail is inserted into the intramedullary canal of the broken proximal femur and anchored in the femoral bone using a coupling device, usually a bone screw. For this purpose, the intramedullary nail often has a bore running transversely to its longitudinal axis, through which the bone screw is inserted, projecting beyond the bore, so that one end of the bone screw extends into the femoral head. Inserting the bone screw generally requires a bone drill channel in the femur, which leads through the bore of the intramedullary nail to the femoral head.For this purpose, a guide wire is usually first inserted into the femoral head and then a cannulated drill is guided along the guide wire to form the bone drilling channel.
[0005] The insertion and positioning of the intramedullary nail is usually performed using a positioning device with a handle to which the nail is coupled. The surgeon then inserts the nail into the intramedullary canal of the femur and aligns it therein by guiding the handle. The handle typically features a targeting system for guiding the guide wire along a targeting axis defined by the targeting system. The targeting system usually runs from the targeting system through the hole of the intramedullary nail.
[0006] A challenge with correct positioning is usually that the intramedullary nail must be correctly positioned in the femur using the positioning device and the guide wire must be guided to a suitable depth in the femoral head. For this purpose, x-rays are usually taken to monitor and identify the position of the intramedullary nail and bone drill. In order to estimate the position of the guide wire in the area of the femoral head in relation to the femoral head, it is known to equip the handle with an alignment sight. The alignment sight has an indicator that is visible in the x-ray image, often in the form of a U-shaped depression. The indicator can be used to show the course of the targeting axis in the x-ray image if a line of sight along which the x-ray image is taken lies in a first alignment plane formed by the targeting axis and the indicator.It is therefore necessary to align the line of sight of the X-ray image such that the line of sight, the indicator, and the target axis lie in the same plane in order to estimate the position or course of the target axis and, accordingly, the guide wire to be inserted along the target axis relative to the femoral head. Such adjustment to align the line of sight, indicator, and target axis often proves to be a difficult task, particularly given the generally limited resolution or visualization capabilities of X-ray images. This involves an extended treatment time and significant radiation exposure for the patient and the surgeon.Since the course of the targeting axis is usually not visible on the X-ray image, it is often necessary to move the guide wire close enough along the targeting axis to the femoral head to allow the femoral head to be visible on the X-ray image. This allows the guide wire to estimate the course of the targeting axis, allowing the targeting axis, the indicator, and the X-ray line of sight to be aligned. This can lead to incorrect positioning of the guide wire in the bone and damage to the femoral bone.
[0007] This is where the invention comes in. The object of the invention is to provide a device of the type mentioned above that enables optimized treatment during the implantation of a bone implant. Furthermore, a corresponding method is to be provided.
[0008] The first object is achieved according to the invention by a device of the type mentioned at the outset, if the alignment sight has a second indicator structure which is designed to indicate, in a first X-ray image of the alignment sight, an orthogonal tilt of the line of sight from the first alignment plane along a line of sight deviating from the desired line of sight in order to enable an adaptation of the line of sight to the desired line of sight.
[0009] The invention is based on the idea of designing the alignment sight in such a way that a tilt of a line of sight of an X-ray image of the alignment sight with respect to the first alignment plane defined by the aiming axis and the first indicator structure can be easily and accurately detected in the X-ray image.
[0010] This can be achieved if an indication of an orthogonal tilt of the line of sight of the first X-ray image with respect to the first alignment plane is decoupled from the first indicator structure, especially since the first indicator structure usually requires a comparison with a course of the aiming axis - for example, by inserting the bone drilling device along the aiming axis in order to be able to detect an orthogonal tilt.
[0011] By providing the alignment sight with a second indicator structure whose function is to indicate in the first X-ray image of the alignment sight that there is an orthogonal tilt of the line of sight from the first alignment plane or to make such a tilt recognizable, such a misalignment can be detected quickly and practically. The line of sight can thereby be aligned such that it lies in the first alignment plane. Thus, the alignment sight, in particular the first indicator structure or second indicator structure, represents a reference point in an X-ray image of the alignment sight for a direction or actual position of the aiming axis, or in particular corresponding to the bone drilling device inserted along the aiming axis, in the bone. In particular, it is not necessary to insert the bone drilling device into the bone in order to use it to detect the aiming axis for adjustment.This allows for the adjustment and alignment of the target axis, the first indicator structure, and the line of sight of the first X-ray image to be performed easily and practically, thus reducing the time required and / or X-ray exposure. By performing the alignment first and only then inserting the bone drill into or into the bone, the potential for damage can be reduced. This allows for optimized treatment during bone implantation.
[0012] The bone drilling device can, for example, be a bone drill or a guide wire, such as a K-wire, also known as a Kirschner wire. As a rule, a guide wire, in particular a K-wire, is first guided into the bone in order to define a drilling path with the guide wire, along which path a bone drill is then guided along the guide wire. For this purpose, the bone drill usually has a feed-through channel for the guide wire in order to guide the bone drill along the target wire. If the guide wire is used as a guide, it is also referred to as a guide wire. The target guidance defines the target axis along which the bone drilling device can be guided with the target guidance. The bone can be a bone part, in particular a proximal femur, or the bone fracture can be a fracture of the femur, in particular of the proximal femur. The first orThe second X-ray image is generally taken with an X-ray machine, which is preferably designed such that the recording direction or line of sight of the X-ray image from which the X-ray image is taken can be varied, in particular in a controlled manner. It is expedient if the tilt angle of the recording direction or line of sight can be varied, preferably in two degrees of freedom, in particular in a controlled manner. It has proven useful if the X-ray machine is designed as a medical C-arm. The X-ray image can be one or more X-ray images.
[0013] The X-ray images, in particular the first or second X-ray image, of the alignment sight are usually taken with a line of sight or recording direction such that the target axis or a target axis segment of the target axis, which is to be displayed with the first indicator structure, and the alignment sight are arranged one behind the other in the X-ray image along the line of sight in order to represent a reference point for the course of the target axis, in particular its course in the bone, with the alignment sight. An alignment of the line of sight, wherein the line of sight has a tilt angle with respect to the first alignment plane that is orthogonal to this or does not correspond to the desired line of sight, is also referred to as coarse alignment. The orthogonal tilt of the line of sight or the recording direction of the first X-ray image from the first alignment plane refers to a tilt of the line of sight orRecording direction relative to the first alignment plane in a direction orthogonal to the first alignment plane. This applies analogously to an orthogonal tilt of the line of sight relative to the second alignment plane described below.
[0014] It is advantageous if the first indicator structure and / or the second indicator structure is formed with at least one elevation and / or at least one depression in order to form a structure that can be identified in an x-ray image, in particular with respectively identifiable structural features. Expediently, a plurality of elevations or depressions can also be provided. The elevations or depressions can be part of an alignment sight base body, which are introduced into the alignment sight base body, for example, by machining. Typically, the connecting element for connecting the intramedullary nail to the handle and the targeting guide are arranged on the handle at a distance from one another, preferably at different ends of the handle.It is expedient if the connecting element and the targeting device are connected to a handle arm of the handle, with the connecting element being arranged at a first end and the targeting device being arranged at a second end of the handle, generally opposite the first end. It is practical for the alignment sight to be formed as part of the first end of the handle or, in particular, to form the first end of the handle. The connecting element can be arranged on the alignment sight, in particular on the alignment sight base body, in particular in a detachable manner.
[0015] It is advantageous if the second indicator structure is formed with a plurality of structural elements arranged one behind the other, at least in sections, in an arrangement direction parallel to the first alignment plane or parallel to the desired line of sight, so that the orthogonal tilt of the line of sight from the first alignment plane is represented or can be recognized by a relative position of the structural elements in the first x-ray image. For example, by a different relative position of the structural elements compared to an intended relative position of the structural elements in the second x-ray image of the alignment sight along the desired line of sight. The structural elements are usually spaced from one another in a direction orthogonal to the arrangement direction. It is understood that in the x-ray image, the structural elements are represented by respective images representing them.The respective structural element can be configured with a protrusion and / or depression or be formed by part of such a protrusion. For example, structural elements configured as protrusions or depressions can be arranged at least partially one behind the other in the arrangement direction, so 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 in the first X-ray image of the alignment sight, with the line of sight tilted orthogonally from the first alignment plane, a different lateral distance or even a lateral distance, for example a gap, is present between the structural elements.It is understood that a relative position and / or a distance of the structural elements in the respective X-ray image relates to the images of the structural elements by which they are represented in the X-ray image. It is advantageous if the second indicator structure, in particular the structural elements, are designed such that they indicate a direction of the orthogonal tilt of the line of sight from the first alignment plane in the first X-ray image. If these or their images therefore indicate in the X-ray image in which of the two directions orthogonal to the first alignment plane the orthogonal tilt exists, then a misalignment of the line of sight can be efficiently detected and corrected.
[0016] This can be expediently implemented in that the second indicator structure has at least two first structural elements and at least one second structural element, which second structural element is spaced from the first structural elements in an arrangement direction parallel to the first alignment plane or parallel to the desired line of sight, such that the first x-ray image of the alignment sight, compared to the second x-ray image of the alignment sight, shows a direction-dependent lateral displacement of the second structural element relative to the first structural elements depending on the direction of the orthogonal tilt of the line of sight from the first alignment plane. The first structural elements are usually spaced from one another in a direction orthogonal to the arrangement direction. For better recognizability, a plurality of first and / or a plurality of second such structural elements can be provided.The first structural elements and the at least one second structural element can, for example, be formed with elevations and / or depressions, wherein the first structural elements and the second structural element are arranged downstream of one another at least in sections in the arrangement direction. For example, the structural elements can be designed and arranged such that a gap, also referred to as a tilt indicator gap, is present between the first structural elements, so that in the second X-ray image along the desired line of sight, the second structural element is arranged in the center of the gap, and in the first X-ray image, with an orthogonal tilt of the line of sight from the first alignment plane, the second structural element is shown shifted towards one or the other first structural element, depending on the direction of the orthogonal tilt of the line of sight from the first alignment plane.
[0017] For good recognizability in the X-ray image, it is advantageous if the second indicator structure is formed with several slit boundary walls, so that the slit boundary walls form two spaced-apart tilt indicator slits in the first X-ray image of the alignment sight, wherein a direction of the orthogonal tilt can be read by comparing the slit widths of the tilt indicator slits. It is expedient if, depending on the direction of the orthogonal tilt of the line of sight from the first alignment plane, one or the other tilt indicator slit has a greater decrease in its slit width. To determine the desired alignment, it has proven useful if the slit boundary walls form two spaced-apart tilt indicator slits with the same slit width in the second X-ray image of the alignment sight or, when the line of sight lies in the first alignment plane.The respective tilt indicator gap is usually formed with at least one of the first structural elements and at least one of the second structural elements, which each form one of the gap boundary walls.
[0018] A practical implementation can be achieved if, to form the respective tilt display gap in the first or second X-ray image, a first gap delimiting wall and a second gap delimiting wall each form a wall pair, wherein the second gap delimiting wall is arranged at least partially downstream of the first gap delimiting wall in the arrangement direction or a direction parallel to the first alignment plane, and wherein in one of the wall pairs the first gap delimiting wall is arranged downstream of the second gap delimiting wall in a first direction orthogonal to the first alignment plane and in the other wall pair in a direction opposite to the first direction, so that depending on the direction of the orthogonal tilt of the line of sight from the first alignment plane in the X-ray image of the alignment sight, one or the other tilt display gap has a greater reduction in its gap width.The respective first gap-delimiting wall and second gap-delimiting wall are typically arranged at a distance from one another in a direction orthogonal to the arrangement direction and can at least partially overlap one another in this direction. In the arrangement direction, the second gap-delimiting walls are preferably arranged between the first gap-delimiting walls. It has proven advantageous if the second gap-delimiting wall of a respective wall pair has a greater longitudinal extent in the arrangement direction than the first gap-delimiting wall. The gap-delimiting walls are preferably designed as rails, each with a longitudinal axis substantially parallel to the arrangement direction. The respective first gap-delimiting wall typically represents one of the first structural elements, and the respective second gap-delimiting wall represents one of the second structural elements.The respective first and second gap boundary walls can be configured to overlap or spaced apart from each other in a direction orthogonal to the arrangement direction. The arrangement direction typically refers to a direction parallel to the first alignment plane or parallel to the desired line of sight.
[0019] High readability can be achieved if the alignment sight is designed such that, in the second X-ray image of the alignment sight, the first indicator structure is arranged between the two tilt indicator columns of the second indicator structures. For simple and quick reading, it is advantageous if the first indicator structure forms a notch in the second X-ray image, with the bottom of the notch preferably indicating the course of the aiming axis. The notch walls of the notch can be formed with structural elements of the second indicator structure. For example, with one of the gap boundary walls of the tilt indicator column.
[0020] It is advantageous if the alignment sight has a third indicator structure which is designed to indicate, in a third x-ray image of the alignment sight, in particular the first and / or second x-ray image of the alignment sight, an orthogonal tilt of the line of sight of the third x-ray image from a second alignment plane which is oriented at right angles to the first alignment plane, in order to align the line of sight of the third x-ray image according to the second alignment plane. This makes it possible to define a reference point for a real position of a segment of the target axis in the bone indicated by the first indicator structure. The third x-ray image can be the first and / or second x-ray image, whereby the line of sight of the first or second x-ray image of the alignment sight then corresponds accordingly to the line of sight of the third x-ray image of the alignment sight.In this way, any misalignment or tilting of the respective line of sight in a direction within or parallel to the first alignment plane can be detected and corrected. By appropriately adjusting the line of sight of a respective X-ray image in relation to the first and second alignment planes, the line of sight can be optimized so that the actual position of the target axis or of the bone drilling device in relation to a bone structure shown in the X-ray image can be better estimated. It is useful if the desired line of sight also lies in the second alignment plane. The desired line of sight is then defined by an intersection line between the first alignment plane and the second alignment plane at which they intersect. It is particularly advantageous if the second alignment plane is aligned orthogonal to the target axis. If this means that the desired line of sight runs orthogonal to the target axis orthe line of sight is adjustable accordingly, longitudinal distances in an X-ray image of the alignment sight along the target line of sight correspond to longitudinal distances along the aiming axis.
[0021] The third indicator structure is preferably formed with a plurality of alignment structures arranged one behind the other in the arrangement direction, so that in the third X-ray image a defined alignment or superimposition of the alignment structures indicates an arrangement of the line of sight of the third X-ray image within the second alignment plane. It is expedient if the third indicator structure is formed by at least one or more elevations and / or at least one or more depressions in order to form a structure that can be identified in the X-ray image. The elevations or depressions can be part of the alignment sight base body or can be introduced into it by machining. The first, second and third indicator structures can be formed by common elevations and / or depressions. The third indicator structure or the alignment structures can be formed in a manner analogous to the first or second indicator structure ortheir structural elements must be implemented.
[0022] It is advantageous if the alignment structures are designed in such a way that they 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 lies in the second alignment plane, wherein each of the alignment structures forms only a partial contour of the target overlay contour. It is understood that it is expedient if the target overlay contour is not formed when the line of sight is tilted orthogonally from the second alignment plane. For example, it can be provided that the target overlay contour represents a depression or elevation with a defined shape, for example a parabolic shape. It is expedient if one of the alignment structures is implemented by a structural feature, for example the aforementioned incision, with which the first indicator structure is formed.It is practical if the alignment structures each form a depression or elevation in the X-ray image.
[0023] The bone implant, in particular the intramedullary nail, is usually detachably connected to the handle via the connecting element of the handle, in particular in a form-fitting and / or force-fitting manner. For this purpose, the connecting element can have a first coupling element which is detachably connectable to a second coupling element of the intramedullary nail that corresponds in shape to the first coupling element, for example by inserting them into one another to create a form-fitting and / or force-fitting connection. The handle is usually connectable to the intramedullary nail in a rotationally rigid manner. Typically, when the bone implant, in particular the intramedullary nail, is connected to the connecting element, a user, usually a surgeon, guides the bone implant to or into the bone by guiding the handle to the bone, in particular inserting it, and aligning it relative to the bone.
[0024] The alignment sight is typically made of a radiopaque material. This makes it a recognizable structure in an X-ray image, particularly one with higher contrast compared to bone and / or tissue. It may be advantageous to construct other parts of the positioning device, such as a handle segment or the handle arm of the handle, on which the targeting system is arranged, from a radiolucent material, so that this presents a structure with lower contrast in the X-ray image compared to the alignment sight or compared to bone and / or tissue.
[0025] It is advantageous if a positioning system is provided for positioning and / or fixing an intramedullary nail in a bone, in particular a proximal femur, for treating a fracture, in particular a fracture of a proximal femur, wherein the positioning system comprises a positioning device and an intramedullary nail which can be inserted into an intramedullary canal of the bone, wherein the intramedullary nail has a bore extending transversely to a longitudinal axis of the intramedullary nail for receiving a coupling device, in particular a bone screw, in order to insert the coupling device into the bore such that the coupling device projects beyond the bore at least on one side, in particular on both sides, wherein the coupling device can be fixed at its end in a bone part, in particular a femoral head, for example with a thread. The positioning device can expediently be designed as described, in particular above.The bone drilling device can be designed as a bone drill or guide wire, in particular a K-wire. It is advantageous if the bone drilling device and / or the coupling device are part of the positioning system. The intramedullary nail is usually, in particular as described above, detachably connectable to the connecting element of the positioning device in order to insert the intramedullary nail into the intramedullary canal of the bone using the positioning device. The intramedullary nail is generally designed such that, when the intramedullary nail is connected to the connecting element, the drilling axis coincides with the targeting axis. The targeting axis usually defines the path along which the bone screw is to be inserted into the intramedullary nail.
[0026] By taking an X-ray image of the alignment sight, in particular according to the aforementioned second X-ray image, an orthogonal tilt of the line of sight from the first alignment plane can be recognized or indicated in the X-ray image using the second indicator structure. The line of sight of the X-ray image and the first alignment plane can thus be aligned with one another, so that when the intramedullary nail is connected, in particular detachably, to the connecting element, a bone drilling device, such as a target wire, in particular a K-wire, can be guided along the target axis with the targeting of the positioning device, in particular through the bore, and has a course in the X-ray image indicated by the first indicator structure.
[0027] It is practical if the target guide has a guide device and a drill guide, wherein the drill guide has a drill channel for guiding the bone drill, wherein the drill guide can be connected to the guide device in a form-fitting, in particular detachably, manner, such that the drill guide can be displaced relative to the guide device along the target axis in order to guide the drill channel to a bone surface of the bone or to the intramedullary nail when the intramedullary nail is inserted into the bone. In this way, the bone drill is protected by the drill guide. The diameter of the drill channel is usually designed to correspond to the diameter of the bone drill. Depending on the bone drill to be used, different drill guides with a drill channel diameter matched to the diameter of the bone drill can be used.Typically, when the drill guide is connected to the guide device, the drill channel is arranged to run along a longitudinal axis of the drill guide, or a longitudinal axis of the drill channel is aligned to run along the target axis, in order to guide the drill along the target axis. The drill channel can be designed, for example, as a drill hole. The drill guide generally has a rod-shaped segment which, when guided by the guide device, forms an end of the drill guide facing the intramedullary nail, or is, in particular, essentially rod-shaped. The guide device and drill guide are usually designed such that the drill guide, in an extended position pushed towards the intramedullary nail, bridges a section between the guide device and the intramedullary nail, in order to guide the bone drill along this section in a protected manner.It is expedient if the drill guide can be guided essentially up to the intramedullary nail, whereby the remaining distance to the intramedullary nail can vary depending on the thickness of the respective bone. Typically, the drill guide is pushed through the body tissue surrounding the bone up to the vicinity of the bone surface of the bone or up to the vicinity of the intramedullary nail. The bone drill can then be guided, protected by the drill guide, in the drill channel up to the vicinity of the intramedullary nail or bone in order to then insert the bone drill further into the bone. The guide device can be formed with a guide channel into which the drill guide can be inserted in a form-fitting manner. The guide channel generally defines a guide channel axis that coincides with the target axis and along which the drill guide can be guided and moved.
[0028] It is advantageous if the target guide has a tissue protection sheath that is movable relative to the guide device in order to at least partially enclose the drill guide in an extended position of the drill guide, in which the drill guide is guided by the guide device towards the bone or intramedullary nail, in order to separate the drill guide from a body part tissue surrounding the bone. In this way, impairment of the body part tissue when the drill guide is moved can be reduced, in particular prevented. The tissue protection sheath can expediently be formed at least in segments with an enveloping surface that, when the drill guide is inserted into the drill guide channel, at least partially, preferably largely, in particular entirely, encloses the drill guide in the circumferential direction of the drill guide. This applies in particular to an end section of the tissue protection sheath facing the intramedullary nail.The tissue protection sleeve is advantageously designed to surround the drill guide in its extended position essentially along a large part, in particular the entire length of the drill guide between the extended position and the guide device. High practicality is achieved if the tissue protection sleeve can be connected to the guide device in a form-fitting, in particular detachable, manner, so that the tissue protection sleeve can be displaced relative to the guide device along the target axis in a guided manner in order to guide the tissue protection sleeve toward a bone surface of the bone or toward the intramedullary nail when the intramedullary nail is inserted into the bone.It is advantageous if the tissue protection sheath comprises a drill guide channel for guiding the drill guide, wherein the drill guide can be connected to the drill guide channel in a form-fitting manner, in particular detachably, such that the drill guide can be moved relative to the tissue protection sheath along the target axis. In this way, the tissue protection sheath can be guided along the target axis between body part tissue up to the vicinity of the bone and the drill guide can then be guided into the extended position. It is practicable if the tissue protection sheath can be inserted in a form-fitting manner into the guide channel of the guide device. The tissue protection sheath can then be inserted in a form-fitting manner into the guide channel of the guide device in order to extend the tissue protection sheath up to the vicinity of the intramedullary nail or
[0029] bone, and then the drill guide is inserted into the drill guide of the tissue protection sheath in a form-fitting manner in order to guide the drill guide, at least partially covered by the tissue protection sheath, into the vicinity of the intramedullary nail or bone.
[0030] It is advantageous if the guide device has a plurality of guide channels, wherein the guide channels are each designed for a displaceably guided connection to a drill guide or a tissue protection sheath, wherein preferably different guide channels define different target axes or guide channel axes in order to guide a bone drill along them. Accordingly, it can be provided that the guide device has at least one or more further guide channels, each defining a further guide channel axis or further target axis, in order to connect a drill guide and / or a tissue protection sheath to the guide device, in particular detachably, in a guided manner displaceably along the further guide channel axis, in particular in the aforementioned manner.A drilling device, such as a bone drill or a guide wire, in particular a K-wire, can then be guided along the additional guide channel axis using the drilling device guide. The intramedullary nail can expediently have at least one or more additional bores, wherein a respective bore axis of the additional bores coincides with one of the guide channel axes. Provision can be made for a further coupling element, such as a bone screw, to be inserted into the respective additional bore, which extends beyond the respective additional bore on at least one or both sides in order to fix the intramedullary nail in the bone.
[0031] It is expedient if the targeting device, in particular the guidance device, is detachably connected to the handle bar arm of the handle bar in order to detach the targeting device or guidance device from the handle bar arm of the handle bar. Expediently, a connecting device can be provided with which the targeting device, in particular the guidance device, and the handle bar arm can be detachably connected to one another, in particular in a form-fitting and / or force-fitting manner. This makes it possible for the targeting device, in particular the guidance device, to be connected to the handle bar only after the intramedullary nail has been inserted into the bone. This facilitates handling during treatment. It is practical if the alignment sight is detachably connected to the handle bar arm with a connecting connection, in particular in a form-fitting and / or force-fitting manner.
[0032] The further object is achieved by a method of the type mentioned above when a first X-ray image of the alignment sight of the handlebar is taken along a line of sight, after which the line of sight is adjusted to the first alignment plane using a second indicator structure of the alignment sight, which is designed to indicate an orthogonal tilt of the line of sight from the first alignment plane in an X-ray image of the alignment sight. Typically, a positioning device or a positioning system described in this document is used to carry out the method. As explained, this allows adjustment or alignment of the aiming axis, first indicator structure, and line of sight of the X-ray image to be carried out simply and practically, thus reducing the time required and / or radiation exposure.
[0033] The target axis is usually aligned transversely to a longitudinal axis of the intramedullary nail, preferably such that it intersects the intramedullary nail or coincides with a drilling axis of a drill hole in the intramedullary nail, as particularly explained above. For the treatment of a proximal femur, the target axis is usually aligned at an angle to the longitudinal axis of the intramedullary nail that is the same as the longitudinal axis of the femur and the longitudinal axis of the femoral neck, usually at an angle of between 110° and 140°. If the bone is a femur, the target line of sight of the X-ray image usually corresponds to a lateral-medial view of the femur or body of which the femur is a part.
[0034] It is expedient for a bone drill, particularly a K-wire, to be guided into the bone along the target axis using the guide of the handle. The line of sight is adjusted based on the second indicator structure before and / or after the bone drill is visible in the first X-ray image for comparison with the first indicator structure. Optimized adjustment of the line of sight can be achieved before and / or after the bone drill is visible in the X-ray image.
[0035] Typically, the intramedullary nail is provided with a bore extending transversely to a longitudinal axis of the intramedullary nail for receiving a coupling device, in particular a bone screw, wherein the bone drilling device, in particular the K-wire, is guided through the bore along the targeting axis via the targeting guide. The bore typically has a drilling axis that coincides with the targeting axis. The bone drilling device can be a bone drill or a targeting wire, in particular a K-wire. The coupling device can be used to fix the intramedullary nail in the bone or to couple bone material of the bone to the intramedullary nail via the coupling device. For this purpose, the coupling device can be inserted into the bore of the intramedullary nail in such a way that the coupling device projects beyond the bore at least on one side, in particular on both sides.The coupling device is typically anchored in the bone material by at least one end of the coupling device, usually the end leading in the direction of insertion of the coupling into the bone. For this purpose, the end may have a thread.
[0036] Typically, a bone drill channel is created in the bone along the target axis using the bone drill, usually through the hole of the intramedullary nail, and the coupling device is then inserted into the hole along the bone drill channel. If the bone is a proximal femur, the bone drill channel typically extends along the target axis into the femoral head. Preferably, the coupling device is inserted into the hole in such a way that one end of the coupling device protrudes into the femoral head or is anchored there, for example, with a thread.
[0037] It is advantageous if a bone drilling device designed as a target wire, in particular a K-wire, which has a smaller diameter than the coupling device, is first introduced into the bone along the target axis, in particular in the manner described above, after which a bone drilling channel is created in the bone along the target axis using a bone drill, with the target wire serving as a guide. The coupling device can then be introduced into the bore via the bone drilling channel, usually in such a way that the coupling device projects beyond the bore at least on one side or both sides. The second bone drilling device or the bone drill and / or the coupling device are generally cannulated in order to guide them along the target wire. For this purpose, the bone drilling device or the coupling device can have a feed-through channel.If the bone is a proximal femur, the coupling device is usually fixed to the femoral head with one end of the coupling device. The guide wire is usually removed after the coupling device has been inserted into the hole of the intramedullary nail and, in particular, inserted into the femoral head.
[0038] It may be advantageous to insert a further guide wire, in particular a K-wire, into the femoral head offset from the axis in order to avoid rotation of the femoral head when drilling the bone drill channel, in particular the second bone drill channel, and / or inserting the coupling device into the bore of the intramedullary nail. □The further guide wire can extend into the femoral head along a further target axis, preferably through a further bore of the intramedullary nail.
[0039] The additional guide wire can be conveniently inserted into the femoral head with the guide device, for example via an additional guide channel of the guide device.
[0040] The first alignment sight X-ray typically refers to an X-ray image of the alignment sight along a line of sight with the line of sight tilted orthogonally from the first alignment plane. The second alignment sight X-ray typically refers to an X-ray image of the alignment sight along a line of sight lying in the first alignment plane.
[0041] Further features, advantages, and effects will become apparent from the following exemplary embodiments. The drawings, to which reference is made, show:
[0042] Fig. 1 a positioning device for an intramedullary nail;
[0043] Fig. 2 and Fig. 3 an alignment sight of a positioning device from different lines of sight;
[0044] Fig. 4 is an X-ray image of a proximal femur along a line of sight lying in a plane with a target axis and first indicator structure;
[0045] Fig. 5 shows another X-ray image according to Fig. 4 with a K-wire inserted into the bone along the target axis;
[0046] Fig. 6 shows the alignment sight of Fig. 2 and Fig. 3 in an oblique plan view of indicator structures of the alignment sight;
[0047] Fig. 7 a guidance device of a destination guidance system;
[0048] Fig. 8 shows a fabric protective cover of a target guide;
[0049] Fig. 9 a drilling rig guide of a target guide.
[0050] Fig. 1 shows a schematic representation of a positioning device 1 for an intramedullary nail 2 for positioning and fixing the intramedullary nail 2 in an intramedullary canal of a bone, in particular a proximal femur. The purpose is usually to treat a bone fracture, in the case of a proximal femur often a femoral neck fracture. The positioning device comprises a handle 3 with a targeting guide 4 for guiding a bone drilling device 5, for example a K-wire, along a targeting axis Z, a connecting element e for connecting the intramedullary nail 2 to the handle 3 in a rotationally rigid and detachable manner, and an alignment sight 7 for displaying a course of the targeting axis Z in an x-ray image for aligning the targeting axis Z when the intramedullary nail 2 is inserted into the bone with the alignment sight 7.The connecting element 6 and the target guide 4 are arranged at a distance from one another on a handle arm 9 of the handle 3, usually at different ends of the handle arm 9.
[0051] The intramedullary nail 2 has a bore 10 extending transversely to its longitudinal axis for receiving a coupling device, such as a bone screw, to secure the intramedullary nail 2 in the bone by inserting the coupling device into the bore 10 so that the coupling device projects beyond the bore 10. The coupling device is typically anchored at the end in a bone portion, in the case of a proximal femur, usually in the femoral head. When the intramedullary nail 2 is connected to the connecting element 6, an axis of the bore 10 and the target axis Z coincide, so that the target axis Z passes through the bore 10, as shown in Fig. 1.Typically, a bone drilling device 5, designed as a K-wire, is first guided through the bore 10 via the target guide 4 along the target axis Z. A bone drill is then inserted into the bone to drill a bone drilling channel 10 along the target axis Z, with the K-wire serving as a guide for the bone drill. The coupling device can then be inserted into the bore 10 of the medullary canal via the bone drilling channel.
[0052] Alignment of the target axis Z in the bone in order to guide the K-wire or the coupling device to a suitable depth and position in the bone is carried out by taking X-ray images of the alignment sight 7, so that in the X-ray images a first indicator structure 11 of the alignment sight 7 represents a reference point for the course of the target axis Z in the bone. The X-ray images are generally taken using an X-ray apparatus 13 with a controllably variable line of sight S1 of the X-ray image. The first indicator structure 11 is designed to indicate the course of the target axis Z in an X-ray image of the alignment sight 7 along a desired line of sight S2 lying in a first alignment plane formed by the target axis Z and the first indicator structure 11. This is shown in Fig. 2, wherein in Fig. 2 the first alignment plane runs through the target axis Z at right angles to the drawing plane.To enable alignment of the line of sight S1 of an X-ray image of the alignment sight 7 according to the desired line of sight S2, i.e., to detect a misalignment of the line of sight S1, the alignment sight 7 is provided with a second indicator structure 12, which is designed to indicate an orthogonal tilt of the line of sight S1 from the first alignment plane in the X-ray image. This is illustrated in Fig. 2 and Fig. 3.
[0053] 2 and 3 show schematic representations of an alignment sight 7 of a positioning device, in particular that of FIG. 1, wherein in FIG. 2 the alignment sight 7 is shown from a view of the alignment sight 7 along the first alignment plane, and in FIG. 3 from a view of the alignment sight 7 under orthogonal tilt from the first alignment plane. The first indicator structure 11 is formed with a depression, so that the first indicator structure 11 forms a notch, in particular a U-shaped or V-shaped one, in an X-ray image along the desired line of sight S2 in order to indicate the course of the aiming axis Z, analogous to FIG. 2. The course of the aiming axis Z is marked in particular by a base of the notch. For precise indication, it is expedient if the depression or the notch has a tapered cross-section along its depth direction.The indicator structures are preferably formed as elevations or depressions introduced into an alignment sight body.
[0054] The second indicator structure 12 is formed with a plurality of gap-delimiting walls, which are aligned essentially parallel to the first alignment plane or parallel to the line of sight S1 and spaced apart from one another, orthogonally to their longitudinal axes, in particular designed as rails, so that the gap-delimiting walls form two spaced-apart tilt indicator gaps 14 in an X-ray image of the alignment sight 7 along the desired line of sight S2, wherein a first gap-delimiting wall 15 and a second gap-delimiting wall 16 form a wall pair to form the respective tilt indicator gap 14, wherein the second gap-delimiting wall 16 is arranged at least in sections downstream of the first gap-delimiting wall 15 in a direction parallel to the first alignment plane,and wherein, in one of the wall pairs, the first gap-delimiting wall 15 is arranged downstream of the second gap-delimiting wall 16 in a first direction orthogonal to the first alignment plane, and in the other wall pair in a direction opposite to the first direction, the first gap-delimiting wall 15 is arranged downstream of the second gap-delimiting wall 16, so that, depending on the direction of the orthogonal tilt of the line of sight S1 from the first alignment plane in the X-ray image of the alignment sight 7, one or the other tilt indicator gap 14 has a greater reduction in its gap width. An arrangement of the gap-delimiting walls is particularly evident in Fig. 2, Fig. 3 and Fig. 6, wherein Fig. 6 shows a schematic representation of the alignment sight in an oblique plan view of the gap-delimiting walls. Through this arrangement of the gap-delimiting walls, a direction of the orthogonal tilt of the line of sight S1 from the desired line of sight S2 is practical and easily legible in the X-ray image. It is advantageouswhen the tilt indicator slits 14 in an X-ray image along the target line of sight S2 have equal slit widths. By arranging the first indicator structure 11 between the tilt indicator slits 14, a particularly sensitive indication of the orthogonal tilt is achievable. As can be seen analogously in Fig. 2 and Fig. 3, the tilt indicator slits 14 in Fig. 2 have equal slit widths, while in Fig. 3, due to the orthogonal tilt, one of the tilt slits 14 has a smaller slit width than the other tilt slit 14, depending on the respective direction of the orthogonal tilt from the first alignment plane.
[0055] It may be practical if the alignment sight 7 has a third indicator structure 17 in order to indicate, in an x-ray image of the alignment sight 7, an orthogonal tilt of the line of sight S1 from a second alignment plane, which is aligned at right angles to the first alignment plane defined by the aiming axis Z and the first indicator structure 11. As a result, the line of sight S1 can also be practically aligned with respect to the second alignment plane. The third indicator structure 17 can preferably be formed with two alignment structures 25 arranged one behind the other in a direction parallel to the first alignment plane, wherein a defined superposition of the depressions forms a desired superposition contour in the x-ray image. This can be done as shown in Fig. 2 and Fig.3 can be implemented in that one of the recesses of the third indicator structure 17 is implemented by the recess of the first indicator structure 11 and a further recess is arranged behind it in a direction of the desired line of sight S2.
[0056] Fig. 4 shows an x-ray image of an alignment sight 7 according to Fig. 2 or Fig. 3 in the context of an exemplary treatment of a fracture of a proximal femur. In particular, the alignment sight 7 is part of a positioning device 1 according to an embodiment according to Fig. 1. The x-ray image shows an alignment of the target axis Z with a femoral head in order to insert a K-wire along the target axis Z into the femoral head after alignment of the target axis Z. The target axis Z is shown as a dashed line in the x-ray image for illustration purposes. The line of sight S1 of the x-ray image is aligned relative to the first alignment plane such that the tilt indicator gaps 14 have essentially equal gap widths, so that the notch of the first indicator structure 11 thus indicates the course of the target axis Z. Fig. 5 shows another x-ray image of the alignment sight 7 according to Fig.4, with a K-wire inserted into the femoral head along the target axis Z. The longitudinal axis of the K-wire runs according to the path indicated by the notch of the first indicator structure 11.
[0057] Fig. 6 shows a schematic representation of the alignment sight 7 of Fig. 2 and Fig. 3 in an oblique plan view of the first indicator structure 11 and second indicator structure 12 of the alignment sight 7. As explained above, one of the first gap boundary walls 15 and one of the second gap boundary walls 16 each form one of the wall pairs in order to form one of the slit display gaps 14 in the x-ray image. The first gap boundary wall 15 and second gap boundary wall 16 of the respective wall pair are spaced from one another in a direction orthogonal to the desired line of sight S2 and can also overlap one another. The recess of the first indicator structure 11 is located between the two wall pairs.The centrally located circular structures shown in Figure 6 represent bore holes in the alignment sight body, which were introduced during the manufacture of the alignment sight 7 for implementing the indicator structures in an alignment sight body of the alignment sight 7.
[0058] To guide the bone drilling device 5 with the target guide 4, it is expedient if the target guide 4 has a guide device 18 and a drilling device guide 19, wherein the guide device 18 is designed to guide the drilling device guide 19, and the drilling device guide 19 is designed to guide the bone drilling device 5, shown in Fig. 1. The guide device 18 is usually detachably connected to the handle arm 9. The drilling device guide 19 can preferably be detachably arranged on the guide device 18. The drilling device guide 19 can be stabilized with the drilling device guide 19 in order to guide the bone drilling device 5 to the bone. The drilling device guide 19 is usually guided to the bone through a body part tissue surrounding the bone.In order to separate the drill guide 19 and body part tissue from one another to protect the body part tissue, it is expedient if the target guide 4 has a tissue protection sheath 20 which at least partially encloses the drill guide 19. Fig. 7 shows a schematic representation of a guide device 18, Fig. 8 a schematic representation of a tissue protection sheath 20 and Fig. 9 a schematic representation of a drill guide 19 of a target guide 4, in particular that of Fig. 1. The guide device 18 has a guide channel 22 in order to insert the drill guide 19 and preferably the tissue protection sheath 20 into the guide channel 22 in a form-fitting manner along the guide channel 22. It is provided that the guide channel 22 is aligned on the handle bar 3 in such a way that a guide channel axis of the guide channel 22 coincides with the target axis Z, so that the drill guide 19 orthe tissue protection sheath 20 is displaceable along the target axis Z, as shown in Fig. 1. The drill guide 19, which is generally substantially rod-shaped, has a drill channel 24 through which a bone drill 5, in particular a K-wire, can be passed. The tissue protection sheath 20 has a drill guide channel 23 for inserting the drill guide 19 into the drill guide channel 23 in a form-fitting manner so that it can be displaced along the drill guide channel 23. The tissue protection sheath 20 is designed to at least partially enclose the drill guide 19. It is expediently provided that the tissue protection sheath 20 can be inserted into the guide channel 22, so that the tissue protection sheath 20 can be extended with the guide channel 22 in the direction of the intramedullary nail 2 relative to the guide channel 22 in order to guide the tissue protection sheath 20 to the intramedullary nail 2 or bone, this is shown in Fig. 1.The drill guide 19 can then be guided along the drill guide channel 23 to the intramedullary nail 2 or bone. It is intended that a longitudinal axis of the drill channel 24 coincides with the target axis Z. A drill, such as a K-wire, can then be guided through the drill channel 24 of the drill guide 19 and inserted into the bone along the target axis Z. If no tissue protection sheath 20 is used, the drill guide 19 can be inserted into the guide channel 22 so that the drill guide 19, guided by the guide channel 22, can be extended relative to the guide channel 22 in the direction of the intramedullary nail 2 in order to guide the drill channel 24 to the intramedullary nail 2. For this purpose, a cross-section of the drill guide 19 can be designed to correspond in shape to a cross-section of the guide channel 22.
[0059] It is therefore advantageous if the positioning device 1 has an alignment sight 7 with a first indicator structure 11 for displaying a course of the target axis Z in an X-ray image of the alignment sight 7 along a desired line of sight S2, wherein the first indicator structure 11 and the target axis Z define a first alignment plane, and wherein the alignment sight 7 has a second indicator structure 12, which is designed to display an orthogonal tilt of the line of sight S1 from the first alignment plane in an X-ray image of the alignment sight 7 along a line of sight S1. As a result, the line of sight S1 of the X-ray image of the alignment sight 7 can be aligned according to the first alignment plane or desired line of sight S2.When the intramedullary nail 2 is inserted into the intramedullary canal of a bone using the positioning device, the first indicator structure thus represents a reference point for a course of the target axis Z in the bone in an X-ray image of the alignment sight 7 with a line of sight S1 adapted to the desired line of sight S2. If the second indicator structure 12 is formed with two tilt indicator columns 14, which are preferably formed with elevations or depressions introduced into an alignment sight body, wherein a direction of the orthogonal tilt from the first alignment plane can be read off from the tilt indicator columns 14, a compact structure and a simple and practical determination of an orthogonal tilt or alignment of the line of sight S1 of an X-ray image can be carried out.
Claims
Patent claims 1. Positioning device (1) for a bone implant, in particular an intramedullary nail (2), for positioning and / or fixing the bone implant, typically for treating a bone fracture, in particular a fracture of a proximal femur, wherein the positioning device (1) has a handle (3) with a target guide (4), such as a target hole, for guiding a bone drilling device (5), wherein the target guide (4) defines a target axis (Z), and wherein the handle (3) has a connecting element (6) for detachably connecting the bone implant to the handle (3), and an alignment sight (7), wherein the alignment sight (7) has a first indicator structure (11) for, in a second X-ray image of the alignment sight (7), along a desired line of sight (S2), which lies in a first alignment plane formed by the target axis (Z) and the first indicator structure (11), with the first indicator structure (11), a course of the target axis (Z),characterized in that the alignment sight (7) has a second indicator structure (12) which is designed to indicate, in a first X-ray image of the alignment sight (7), an orthogonal tilt of the line of sight (S1) from the first alignment plane along a line of sight (S1) deviating from the desired line of sight (S2), in order to enable an adaptation of the line of sight (S1) to the desired line of sight (S2).
2. Positioning device (1) according to claim 1, characterized in that the first indicator structure (11) and / or the second indicator structure (12) is formed with at least one elevation and / or at least one depression in order to form a structure identifiable in an X-ray image.
3. Positioning device (1) according to claim 1 or 2, characterized in that the second indicator structure (12) is designed such that it indicates a direction of the orthogonal tilt of the line of sight (S1) from the first alignment plane in the first X-ray image.
4. Positioning device (1) according to one of claims 1 to 3, characterized in that the second indicator structure (12) is formed with a plurality of gap-limiting walls, so that the gap-limiting walls in the first X-ray image of the alignment sight (7) form two tilt display gaps (14) spaced apart from one another, wherein a direction of the orthogonal tilt can be read by comparing the gap widths of the tilt display gaps (14).
5. Positioning device (1) according to claim 4, characterized in that in order to form the respective tilt display gap (14) in the X-ray image, a first gap-delimiting wall (15) and a second gap-delimiting wall (16) form a wall pair, wherein the second gap-delimiting wall (16) is arranged at least partially downstream of the first gap-delimiting wall (15) in a direction parallel to the first alignment plane, and wherein in one of the wall pairs in a first direction orthogonal to the first alignment plane and in the other wall pair in a direction opposite to the first direction, the first The gap boundary wall (15) is arranged downstream of the second wall boundary wall (16), so that depending on the direction of the orthogonal tilt of the line of sight (S1) from the first alignment plane in the X-ray image of the alignment sight (7), one or the other tilt indicator gap (14) has a greater decrease in its gap width.
6. Positioning device (1) according to claim 4 or 5, characterized in that the alignment sight (7) is designed such that in the second X-ray image the first indicator structure (11) is arranged between the two tilt display columns (14), wherein preferably the first indicator structure (11) is implemented with a notch.
7. Positioning device (1) according to one of claims 1 to 6, characterized in that the alignment sight (7) has a third indicator structure (17) which is designed to indicate in a third X-ray image of the alignment sight (7), in particular the first and / or second X-ray image of the alignment sight (7), an orthogonal tilt of the line of sight of the third X-ray image from a second alignment plane which is aligned at right angles to the first alignment plane, in order to align the line of sight of the third X-ray image according to the second alignment plane.
8. Positioning device (1) according to claim 7, characterized in that 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 desired line of sight (S2), so that in the third X-ray image a defined alignment or superposition of the alignment structures (25) indicates an arrangement of the line of sight of the third X-ray image within the second alignment plane.
9. Positioning system for positioning and / or fixing an intramedullary nail (2) in a bone, in particular a proximal femur, for treating a fracture, in particular a fracture of a proximal femur, wherein the positioning system comprises a positioning device (1) and an intramedullary nail (2) which can be inserted into an intramedullary canal of the bone, wherein the intramedullary nail (2) has a bore (10) extending transversely to a longitudinal axis of the intramedullary nail (2) for receiving a coupling device, in particular a bone screw, in order to insert the coupling device into the bore (10) in such a way that the coupling device projects beyond the bore (10) at least on one side, in particular on both sides, wherein the coupling device can be fixed at its end in a bone part, in particular a femoral head, characterized in that the positioning device (1) is designed according to one of claims 1 to 8.
10. Positioning system according to claim 9, characterized in that the target guide (4) has a guide device (18) and a drill guide (19), wherein the drill guide (19) has a drill channel (24) for guiding the bone drill (5), wherein the drill guide (19) can be connected to the guide device (18) in a form-fitting, in particular detachable, manner, so that the drill guide (19) can be displaced in a guided manner relative to the guide device (18) along the target axis in order to guide the drill channel (24) to a bone surface of the bone or to the intramedullary nail (2) when the intramedullary nail is inserted into the bone.
11. Positioning system according to claim 10, characterized in that the target guide (4) has a tissue protection sheath (20) which is movable relative to the guide device (18) in order to at least partially enclose the drill guide (19) in an extended position in which the drill guide (19) is guided in the direction of the bone or intramedullary nail (2) in order to separate the drill guide (19) from a body part tissue surrounding the bone.
12. A method for treating a bone fracture, in particular a proximal femur fracture, wherein an intramedullary nail (2) is inserted into an intramedullary canal of a bone, in particular a proximal femur, using a positioning device (1), in particular a positioning device (1) according to one of claims 1 to 8, wherein the intramedullary nail (2) is connected, in particular detachably, to a handle (3) of the positioning device (1), wherein the handle (3) has a target guide (4) for guiding a bone drilling device (5) into the bone along a target axis (Z), wherein the handle has an alignment sight (7) for aligning the target axis (Z), wherein the alignment sight (7) has a first indicator structure (11) which is designed to be visible in a second X-ray image of the alignment sight (7) along a desired line of sight (S2),which lies in a first alignment plane formed by the aiming axis (Z) and the first indicator structure (11), to indicate a course of the aiming axis (Z), characterized in that a first X-ray image of the alignment sight (7) of the handle (3) is taken along a line of sight (S1), after which an adjustment of the line of sight (S1) to the first alignment plane is carried out using a second indicator structure (12) of the alignment sight (7), which is designed to indicate an orthogonal tilt of the line of sight (S1) from the first alignment plane in an X-ray image of the alignment sight (7).
13. The method according to claim 12, characterized in that a bone drilling device (5), in particular a K-wire, is guided into the bone along the target axis (Z) via the target guide (4) of the handle (3), wherein the adjustment of the line of sight (S1) based on the second indicator structure (12) takes place 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. Method according to claim 12 or 13, characterized in that the intramedullary nail (2) has a bore (10) extending transversely to a longitudinal axis of the intramedullary nail (2) for receiving a coupling device, in particular a bone screw, wherein the bone drilling device (5), in particular the K-wire, is guided via the target guide (4) through the bore (10) along the target axis (Z).
15. The method according to claim 15, characterized in that first a bone drilling device designed as a target wire, in particular a K-wire, which has a smaller diameter than the coupling device, is guided along the target axis (Z) through the bore (10), after which a bone drilling channel is introduced into the bone along the target axis (Z) using a bone drill, the target wire serving as a guide, after which the coupling device is introduced into the bore (10) via the bone drilling channel.