Method for producing a template for a bone plate

Abstract

The invention relates to a method for producing a template for a bone plate for treating a fracture of a bone of a human or animal, in particular for a bone plate for treating a pelvic fracture of a human. According to the invention, in order to produce the template in a patient-specific manner with high practical applicability, a digital data set of an image of bone fragments of the fracture is obtained using an imaging method, in particular an MRI or CT or X-ray method, wherein the method comprises the following steps: a) creating a digital, in particular virtual, three-dimensional bone model of the bone fracture fragments on the basis of the data set; b) determining a digital template design adapted to the bone model; c) producing, in particular 3D printing, the template on the basis of the determined template design. The invention also relates to a data processing device, to a system for producing the template, and to a computer program product.

Description

[0001] Method for manufacturing a template for a bone plate

[0002] The invention relates to a method for manufacturing a template for a bone plate for treating a fracture of a bone in a human or animal, in particular for a bone plate for treating a pelvic fracture in a human.

[0003] Furthermore, the invention relates to a device for data processing.

[0004] Furthermore, the invention relates to a system for manufacturing a template for a bone plate for treating a fracture of a bone in a human or animal, in particular for a bone plate for treating a pelvic bone fracture in a human.

[0005] Furthermore, the invention relates to a computer program product.

[0006] To treat a pelvic fracture, it is known to surgically fix bone fragments with a bone plate, which is screwed to the fragments. This can be complex, as bone fragments in a pelvic fracture can be relatively large and displaced. The bone plate is usually made of metal, particularly titanium or steel. Typically, the bone plate is adapted to the specific pelvic fracture by deforming it. It is known to use a template for this purpose, which is usually a readily deformable plate that corresponds to the shape of the bone plate to be inserted.Typically, a template is surgically adapted to the pelvic fracture by bending it. Subsequently, usually in a non-surgical setting, the bone plate is shaped by bending it to match the template. The bone plate can then be surgically implanted to fix the bone fragments and treat the pelvic fracture.

[0007] This is where the invention comes in. The object of the invention is to provide a method of the type mentioned above, which enables the production of a template with high practicality and is patient-specific. Furthermore, it is an object of the invention to provide a device for data processing of the type mentioned above, which is configured to enable the determination of a template design for a bone plate with high practicality and is patient-specific for the production of a template.

[0008] Furthermore, it is an objective of the invention to provide a system of the type mentioned above with which the production of a template with high application practicality is made possible in a patient-specific manner.

[0009] Furthermore, it is an objective of the invention to provide a computer program product of the type mentioned above, with which the production of a template, in particular a template design of the template, is made possible with high application practicality in a patient-specific manner.

[0010] The object of the invention is achieved by a method of the type mentioned at the outset, in which a digital data set of an image of bone fragments of the fracture is obtained using an imaging technique, in particular MRI or CT or X-ray technique, wherein the method comprises the following steps: a) creation of a digital, in particular virtual, three-dimensional bone model of the bone fragments based on the data set; b) determination of a digital template design adapted to the bone model; c) manufacture, in particular 3D printing, of the template based on the determined template design.

[0011] In this way, the template can be created to match the virtual bone model, and subsequently, the bone plate can be manufactured according to the template, specifically deformed using the template. This allows for a reduction in surgical intervention for the patient and / or the creation of a template, particularly its design, with a high degree of conformity to the bone fragments. The template is typically manufactured using a production process. This process can be a casting process, a machining process, or preferably, additive manufacturing, or a combination thereof. Significant efficiency can be achieved by producing the template using 3D printing. The manufacturing process allows the template to be produced according to the determined template design, and in particular, to be realized as a physical object.This makes it possible to produce the template, especially its shape, in a patient-specific manner.

[0012] The template design, or template, is typically created for the bone plate to deform, particularly bend, the bone plate according to the manufactured template. This deformation, especially bending, can be achieved by applying and shaping the bone plate against the template. This is usually done using the manufactured template. The template can also serve as a tool for attaching the bone plate to the bone fragments, as explained in more detail later in this document. The deformation, especially bending, of the bone plate is usually performed by a user, particularly a surgeon. The template design typically defines the template to be manufactured, especially its shape.Typically, the template design and / or the template to be manufactured, in particular its design, is tailored to the bone plate, in particular its design, in order to implement a shape of the bone plate, at least partially, in particular predominantly, preferably substantially entirely, according to the manufactured template, by deforming, in particular bending, the bone plate. This can be implemented as described above.

[0013] The imaging procedure may be computed tomography (CT), magnetic resonance imaging (MRI), or X-ray. The digital dataset typically represents an image of the fracture, specifically the bone fragments, generated by the imaging procedure. The digital dataset may be implemented according to DICOM (Digital Imaging and Communications in Medicine), specifically as a DICOM dataset. The imaging procedure may be referred to as an imaging technique. The image generally describes a three-dimensional representation and / or arrangement of the bone fragments relative to each other, obtained by the imaging technique. This allows for the creation of the three-dimensional bone model based on the dataset, particularly in step a). The bone model is usually computer-generated.The bone model is typically implemented as a digital twin of the bone fragments. The digital bone model can be a virtual bone model. The bone model can be created using electronic data processing equipment. The determination of the template design can be carried out using the data processing equipment, particularly depending on user interactions such as user input. Steps a) and b) are typically computer-aided, specifically computer-implemented, and implemented using the data processing equipment. The bone model can be visually displayed to a user, particularly using an electronic imaging device. The imaging device can be part of the data processing equipment. Typically, in step a) and / or b), the bone model is visualized for the user.

[0014] The determination of the template design performed in step b) can be fully automated or carried out with user interactions, in particular dependent on these user interactions. The user interactions can be user input. For example, the user interactions can specify a location and / or extent of the template design relative to the bone model. The template design is usually represented by template design data, and in particular implemented by this data. The template design, and in particular the template design data, usually describes a design, in particular a shape and / or geometric properties, of the template to be produced. Steps a) and / or b) are usually carried out using computer implementation. The template design can be generated dependent on the user interactions, in particular using computer implementation.In step b), template design data can be generated, representing the template design adapted to the bone model. Typically, in step c), the template is manufactured based on the template design determined in step b), in particular the template design data. Manufacturing, specifically the execution of the manufacturing process, can be carried out using a manufacturing device. The manufacturing device may include, and in particular be, a 3D printer for 3D printing the template. The template design determined in step b) is usually transmitted to the manufacturing device, in particular the 3D printer. This is generally done by transmitting the template design data to the manufacturing device, in particular the 3D printer.The stencil design data can be converted into a data format suitable for the manufacturing device, in particular the 3D printer, for printing the stencil based on the stencil design data, and / or transmitted to the manufacturing device, in particular the 3D printer, in such a data format. This can be done after the stencil design has been determined and / or in step b). The manufacturing device, in particular the 3D printer, is usually configured to print the stencil according to the stencil design data.

[0015] It is advantageous if, in step b), the template design is determined, in particular calculated, based on the design parameters of an initial design of a template type and / or an initial design of a bone plate type. The template type can correspond to the template to be manufactured. The initial design is usually described by its design parameters. The bone plate type can correspond to a bone plate for which the template is being manufactured. The respective initial design, in particular its design parameters, can define a shape, geometric properties, a surface form, a relative position and / or orientation of openings, especially openings for the insertion of fastening elements, such as bone screws, of the respective template type or bone plate type.This can refer to one or more segments or essentially to the entire design of the respective template type or bone plate type. These properties of the respective initial design can each be described by the design parameters. The openings can be those described in this document. The design parameters and / or the respective initial design can correspond to a non-adapted state of the template design with respect to the bone model. In practical terms, it is possible for the initial design to be selected in step b) from several designs of different bone plate types and / or from several designs of different template types, particularly by a single user. Alternatively, the initial design can be predefined. Typically, the adapted template design is determined, in particular calculated, based on the design parameters of the initial design.The selection can be fully automated or dependent on user interactions, particularly user input. Design parameters, especially as described above, can be assigned to the respective initial design, which describe the respective initial design. The respective design parameters can be configured as described above in this document. It may be advantageous if the template design is determined in such a way that the template design corresponds to, and in particular represents, a deformed, especially bent, state of the initial design. The bone plate, and in particular its design, for which the template is manufactured, can correspond to, and in particular be represented by, the initial design at least partially, preferably substantially.The respective initial design, in particular in the form of the design parameters of the respective initial design, may be provided to the data processing device, in particular stored in a memory of the data processing device.

[0016] It is advantageous if, in step b), particularly for determining the template design, a digital, especially virtual, template model and / or a digital, especially virtual, bone plate model is generated. The template model and / or the bone plate model can be adapted to the bone model, especially its bone fragments, and / or be adapted to it, particularly to determine the template design. The template design can be formed based on, and especially according to, the template model and / or bone plate model adapted to the bone model. In particular, the template design can represent, or specifically be, the template model adapted to the bone model. The template model and / or bone plate model in a respective state adapted to the bone model can be referred to as the adapted template model and / or adapted bone plate model.For example, it can be practical to adapt the bone plate model to the bone model, especially its bone fragments, and to generate, or in particular calculate, the template design according to the bone plate model adapted to the bone model. The template model and / or the bone plate model can be implemented multidimensionally, especially three-dimensionally. This allows for high accuracy in adapting the template design and / or simple user control. The template model and / or the bone plate model can be formed according to the initial design, especially the design parameters of the initial design, the template type, or the bone plate type. It is advantageous if the template model and / or bone plate model can be adapted to the bone model, especially its bone fragments, by manipulating these elements. This can be particularly useful for a specific shape of the template model or bone plate model.The following applies to bone plate models. The adaptation, in particular the manipulation, is usually performed virtually. Manipulation can involve deformation, especially bending. The adaptation to the bone model can be achieved by forming a contact surface of the template model and / or bone plate model corresponding to the surface topography of the bone fragments of the bone model. It is advantageous if the template model and / or the bone plate model is manipulated, in particular deformed or bent, depending on user interactions in order to adapt the template model and / or bone plate model to the bone model, in particular the bone fragments of the bone model. The respective adaptation to the bone model, in particular the manipulation, of the template model and / or bone plate model can be calculated, in particular simulated.This can be achieved using an adaptation algorithm, particularly a deformation algorithm, which is typically performed with the data processing unit. The deformation can involve bending the template model or bone plate model around one or more bending axes. The template model and / or bone plate model can each have an initial shape. Manipulation can begin from the respective initial shape. The design parameters of the respective initial design can refer to the respective initial shape. In particular, the template model and / or the bone plate model can be manipulated, especially deformed, starting from a non-adapted state. The non-adapted state can correspond to the respective initial shape.For example, starting from the non-adapted state, the template model and / or the bone plate model can be manipulated relative to the bone model based on user interactions to determine the adapted template design. The template model and / or the bone plate model can be visualized to the user, particularly in step b), especially together with the bone model and preferably superimposed on the bone model. Visualization can be performed using the electronic imaging device. It has proven advantageous to visualize the template model and / or the bone plate model in different visualization states, particularly sequentially, wherein the visualization states include a visualization state before the respective manipulation, particularly deformation, and a visualization state after the respective manipulation, particularly deformation.The visualization state before deformation can correspond to the respective non-adjusted state. The visualization state after deformation can correspond to the respective adjusted state. It is advantageous if, particularly with regard to the visualization states, the deformation, especially bending, of the template model and / or bone plate model is visualized step by step or continuously.

[0017] The electronic imaging device can include a display device, in particular a screen, to visualize the models, especially the bone model and preferably the template model and / or the bone plate model, for the user. It is advantageous if the respective visualization, in particular of the bone model, takes place in a virtual environment, especially an interactive one. This preferably also applies to the visualization of the template model and / or the bone plate model. This can be done in step b). In particular, the electronic imaging device can be configured to generate the virtual environment, especially an interactive one, for the user. The virtual environment can be a virtual reality environment. For this purpose, the electronic imaging device can, for example, include a virtual reality headset or virtual reality glasses to display the virtual reality environment to the user.The imaging device may include controls for user interaction. For example, the controls may be configured to allow the user to move a pointer relative to the bone model and / or to define reference points relative to the bone model. It is advantageous if the pointer and / or the reference points are displayed by the imaging device, particularly in the virtual environment. The user interactions described in this document can be performed using these controls. In particular, user interactions for controlling the process, especially the determination of the template design, can be performed in this way. This applies especially to controlling manipulation of the bone model and / or the template model and / or the bone plate model to determine the adapted template design.

[0018] It is practical if, particularly in step b), the determination of the template design depends on user interactions, especially user input. The user interactions can specify one or more locations and / or one or more extents, for example, extension lines, relative to the bone model. It is advantageous if the template design is generated and / or manipulated based on the user input, especially locations and / or extents, particularly relative to the bone model. This can apply analogously to the template model and / or bone plate model. It is advantageous if reference points relative to the bone model can be defined and / or manipulated using the user interactions to specify the locations and / or extents. This can be done using the control elements.It is advantageous if the reference points are specified in such a way that they lie on a bone surface of the bone fragments of the bone model. It is practical to define an extension line by positioning several of the reference points at intervals from one another, with the extension line indicating one of the extensions. Several such extensions can be specified, particularly in the manner described. The design parameters can include descriptive data, in particular reference point data and / or extension line data, which describe a respective shape and / or extension of the template type or bone plate type. It is practical to relate the reference points and / or the respective extension line to the descriptive data in order to determine the template design.The reference points and / or the extension line can be visualized for the user, particularly relative to the bone model, usually with the imaging feature. The reference points are typically geometric reference points relative to the bone model.

[0019] Typically, in step b), particularly for determining the template design, the template design is configured such that the respective initial design, especially its design parameters, is adapted to the bone model, particularly the bone fragments of the bone model. This applies in particular to a shape of the initial design described by the design parameters. This can be implemented such that the shape of the template corresponds to a surface topography of the bone fragments of the bone model. This can also apply, in particular alternatively or cumulatively, to determining the template design in an analogous manner for a configuration of the bone plate model and / or the template model, whereby these are adapted to the bone model.Typically, the respective support surface is implemented with several support surface sections, which are designed for arrangement on different bone fragments.

[0020] It is advantageous if, in step b), the bone fragments of the bone model are generated and, in particular, visualized in an adapted arrangement with fracture reduction in order to determine the template design adapted to the adapted arrangement. This is usually done in step b) before determining the template design. The determination of the template design described in this document can then be carried out with reference to, and specifically adapted to, the adapted arrangement of the bone fragments of the bone model. Fracture reduction can be implemented by a reduced fracture spacing or by a composite shape of the bone fragments. The adapted arrangement can be a planned postoperative arrangement of the bone fragments relative to each other. Fracture reduction can be created entirely automatically or with user interaction, in particular by simulation.It is advantageous if the bone fragments can be manipulated based on user interactions to arrange them relative to each other while reducing the fracture. For example, it is practical if the bone fragments of the bone model can be moved relative to each other based on user interactions to achieve fracture reduction. This movement can involve shifting the bone fragments relative to one another. It is advantageous if the movement of the bone fragments is visualized, preferably stepwise or continuously. This is typically done using the imaging device. The user interactions can be user input. The user interactions can be implemented and / or performed according to the user interactions described in this document. This can be done using the imaging device's controls.

[0021] It is advantageous if the adapted arrangement, particularly the fracture reduction, of the bone fragments in the bone model is generated by mirroring a corresponding healthy bone segment from the opposite side of the body. This allows for efficient fracture reduction. For example, if the bone is a pelvis and the fracture is located on a pelvic segment on one side of the body, selected from either the left or right side, the fracture reduction can be generated by mirroring a corresponding healthy pelvic segment on the other side. The digital dataset typically includes an image of the corresponding healthy bone segment.The image of the healthy bone segment can be included as part of the image of the fracture fragments or as a separate image taken using the same imaging technique. The respective half of the body usually refers to the side of the body that has the fracture.

[0022] The bone plate and / or the respective type of bone plate typically has openings to allow the plate to be attached to the respective bone fragment during surgical use, using fasteners, particularly screws. The fastener may be a fixing bolt, especially a fixing screw, nail, or pin, or a forceps tool. The fixing screw may be a bone screw. The initial design may define corresponding openings. It is advantageous if the template design defines openings and / or the template is formed with openings that correspond to the openings of the bone plate, particularly those of the initial design. The template model and / or bone plate model may have corresponding openings.The openings of the template design can be implemented according to the openings of the adapted template model or adapted bone plate model. It may be useful to specify the positioning of one or more of the openings relative to the bone model, particularly on the bone model itself, using reference points. Generally, precise positioning and / or alignment of the fastening axis of the respective fastener is relevant to establish a robust connection between the bone plate and the bone fragments. However, the opening in the bone plate, through which the fastener is inserted during surgical use to secure the bone plate to the respective bone fragment (especially by screwing it in), often does not provide sufficient guidance to determine the positioning and / or alignment of the fastener with high accuracy.

[0023] It is advantageous if, in step b), attachment points and / or axes for positioning fastening elements are defined, and in particular determined, on the bone model. These fastening elements are used to attach the bone plate to the bone fragments, especially during surgical procedures. The attachment points and / or axes can be defined, and in particular determined, entirely automatically and / or through user interaction. Typically, during surgical procedures, each fastening element is connected to the bone plate at the respective attachment point through a corresponding opening in the bone plate. This connection is usually at least partially countersunk into the bone plate, typically by screwing it in, with the fastening element usually aligned along the respective attachment axis.The template design and / or, particularly in step c), the template itself can be designed with guide channels corresponding to the fixation points and / or fixation axes. The template model can be designed with such guide channels. Typically, the guide channels are the respective openings shown above. In this way, the template can be used to guide a drill or one of the fixation elements through the respective guide channel according to the respective fixation axis, particularly to the respective fixation point, during surgical use. The template can then serve as a tool for fixing the bone plate to the bone fragments during surgical use. The template can be referred to as a drilling template. The respective guide channel is usually associated with one of the openings in the bone plate.The guide channels can be incorporated into the template in step c) using the manufacturing process, in particular 3D printing, and / or, in particular after the manufacturing process, in particular 3D printing, by machining, in particular drilling. Typically, the axis of a guide channel, and in particular its orientation, corresponds to the respective determined mounting axis, and in particular its orientation. The template design, and in particular the template design data, can define the guide channels accordingly. The template design can be determined by implementing the guide channels accordingly.

[0024] It is advantageous if the template design and / or the template itself is designed with guide channels such that each guide channel corresponds to a specific opening in the bone plate, in a state adapted to the bone model. This allows a drill or fastener to be guided through the opening in the bone plate via the guide channel when the template is positioned on the bone plate. The template design, and in particular the template design data, can define the guide channels accordingly. The configuration of the guide channels, especially their axes, can be determined, and in particular calculated, based on the bone model, specifically based on the adapted template model and / or bone plate model, and typically based on the fixation points and / or fixation axes.In surgical applications, the template can be positioned on the bone plate to secure the bone plate to the bone fragments. The template is designed so that the guide channel and the corresponding opening in the bone plate are aligned vertically. This allows the drill or fastener to be guided through the opening via the guide channel to the respective bone fragment. The axis of each guide channel typically aligns with the determined attachment axis. The template can be designed with corresponding guide channels. Positioning the template on the bone plate is usually temporary. This positioning can be achieved by creating a positive-locking and / or force-locking connection, which is typically releasable, between the template and the bone plate.The template design and / or the template itself can be configured to create a positive-locking and / or force-locking connection between the template and the bone plate, particularly when the bone plate is adapted to the bone model, as described above. The template design and / or the template can be configured with one or more attachment elements that correspond, in particular form-matching, to the bone plate, especially to an edge of the bone plate, in order to form a positive-locking and / or force-locking connection with the bone plate. For example, the respective attachment element(s) can be configured to engage the edge of the bone plate, in particular in a positive-locking manner, to form the connection.The design of the fastening elements can be determined, and in particular calculated, based on the adapted template model and / or adapted bone plate model.

[0025] It can be practical to determine the template design based on the fixation points and / or axes. The template design can be determined such that the openings, particularly guide channels, of the template design are formed and / or arranged according to the fixation points and / or axes. This can be done based on properties, especially the shape and / or position, of openings in the corresponding original template design and / or bone plate type. The fixation points and / or axes can be determined based on the thickness and / or density distribution of the respective bone fragment. The thickness and / or density distribution can be specified by the radiograph dataset and / or represented in the bone model.The determination of the attachment points and / or axes can be fully automated or performed with user interaction. The template model and / or the bone plate model can be adapted to the bone model such that the openings of the template model and / or the bone plate model are formed according to the specified attachment points and / or axes.

[0026] It is advantageous if, in step b), the template design is adapted to correspond to a section of one of the bone fragments or to sections of the bone fragments of the bone model, so that the template can be applied to one or more bone fragments according to the bone model, forming a form-fit. This allows the template to apply a tensile force to the respective bone fragment or to hold the bone fragments in position relative to each other. In this way, the template can be used as a tool during surgery to pull the respective bone fragment with the template and / or to hold the bone fragments in position relative to each other. Holding them in position relative to each other can be achieved by applying a tensile force to the bone fragments.This can be practically implemented if, in step b), the template design is adapted to correspond to a section of one of the bone fragments or to sections of the bone fragments of the bone model in such a way that the template model can be applied to one or more bone fragments of the bone model in order to apply a tensile force to the respective bone fragment or to hold the bone fragments in position relative to each other. It is advantageous if such application of the template model is simulated, particularly with the electronic data processing device, and / or visualized, particularly with the imaging device. The template design, in particular the template model or the template itself, can be implemented with one or more projections and / or one or more hooks to enable application with positive locking.

[0027] For optimal usability, it is advantageous if the template in step c) is manufactured using a biocompatible and / or sterilizable material. This reduces the risk of complications during surgical use of the template, particularly when used internally. It is practical to manufacture the template for a set consisting of, and especially from, the bone plate and the template, specifically to form the template for the set. The bone plate can typically be deformed, particularly bent, according to the template shape of the manufactured template to adapt it to the bone fragments of the fracture. The template can be designed with guide channels to guide a drill bit or a fastener, especially a fixing screw. This can be implemented as described in this document.The bone plate is usually composed predominantly, especially essentially, of metal, particularly titanium and / or steel.

[0028] The recording of the bone fragments of the fracture with the imaging device

[0029] The imaging procedure to generate the data set can be performed as part of the process. The imaging procedure can be computed tomography (CT), magnetic resonance imaging (MRI), or X-ray. The surgical application is typically surgical. The manufactured template can be used as part of a surgical procedure to treat a fracture of a bone, particularly a pelvic bone, in a human or animal with a bone plate. The bone plate is typically shaped according to the template. This can be implemented as described in this document.

[0030] A coordinate system, usually three-dimensional, can be assigned to the bone model. The template design can be determined with reference to the coordinate system. The template model and / or the bone plate model can be defined with respect to the coordinate system. The reference points and / or the respective extent, in particular the line of extension, can be determined with respect to the coordinate system. The respective initial design can be specified with respect to the coordinate system. The three-dimensional coordinate system usually specifies a spatial arrangement. The three-dimensional coordinate system can be part of a coordinate system with more than three dimensions. Scaling of the bone model and scaling of the template design are usually associated with each other, especially for determining the template design. In particular, they can have the same scale.This applies analogously to scaling the template model, the bone plate model and / or the initial design in relation to scaling the bone model.

[0031] The further stated objective of the invention is achieved with a data processing device of the type mentioned at the outset if the data processing device comprises means, in particular at least one processor, which are adapted to perform steps a) and b) of the method described in this document. The data processing device, in particular the means, can be used for the method, in particular as part of the method, for producing the stencil, in particular as described in this document, and can be implemented with corresponding features and effects. The processor can, for example, be formed with, in particular from, one or more graphics processors (also referred to as GPUs or graphics processing units). The data processing device can be the data processing device described in this document.

[0032] The further stated objective of the invention is achieved with a system of the type mentioned at the outset if the system comprises a device configured to perform steps a) and b) of the method described in this document, and a manufacturing device, in particular a 3D printer, configured to perform step c) of the method described in this document. The device may be the data processing device. The system for manufacturing a stencil is specifically configured to carry out the method for manufacturing a stencil described in this document. The system for manufacturing a stencil may be configured according to the features and effects described in the context of the method for manufacturing a stencil in this document. The same applies analogously to the method for manufacturing a stencil with regard to the system.Specifically, the system may include a recording apparatus which is configured to perform the imaging recording procedures described in this document.

[0033] The further stated objective of the invention is achieved with a computer program product of the type mentioned at the outset if the computer program product comprises instructions that cause the data processing device described in this document to perform steps a) and b), or the system described in this document to perform steps a) to c) of the method described in this document. It is advantageous if the computer program product is designed as part of the data processing device and / or the system, or is installed on it as intended. This applies analogously in the reverse direction. It is advantageous if a computer-readable storage medium is available on which the computer program product is stored.

[0034] Further features, advantages, and effects will become apparent from the exemplary embodiment described below. The drawing, to which reference is made, shows: Fig. 1 a schematic diagram of a process for manufacturing a template for a bone plate.

[0035] Figure 1 schematically illustrates a process 1 for manufacturing a template for a bone plate. The bone plate serves to treat a bone fracture, preferably a pelvic fracture. The process comprises a step a) in which a virtual three-dimensional bone model of the bone fragments is created based on a digital dataset obtained from an imaging procedure of the fracture or bone fragments. The dataset can be provided to the process. It can be advantageous if performing the imaging procedure is part of the process, particularly in a step aO) of the process performed before step a). It is advantageous if the bone model is visualized for a user in a virtual environment, especially an interactive one. The virtual environment can be a virtual reality environment.

[0036] In step b) of the procedure, a template design adapted to the bone model is determined, which describes a template design adapted to the bone model. For this purpose, the template design is typically determined, in particular calculated, based on design parameters of an initial design of a template type and / or an initial design of a bone plate type. It is practical for the user to select the respective initial design from several different bone plate types and / or template types. It has proven effective to generate a digital, especially virtual, three-dimensional bone plate model based on the initial design of the bone plate type, whereby the bone plate model is adapted to the bone fragments of the bone model in order to generate the template design based on the adapted bone plate model.The bone plate model can be adapted through user interaction, in particular by deforming the bone plate model. Analogously, this can be done, especially alternatively or cumulatively, using a template model generated based on the initial template design. The bone plate model and / or template model can be visualized for the user in the virtual environment, in particular together with the bone model and preferably superimposed on the bone model.

[0037] In step b), prior to determining the template design, the bone fragments of the bone model can be generated and visualized in a modified arrangement with a reduced fracture spacing or in a composite form. This allows the template design to be adapted to the modified arrangement of the bone fragments. Generating the modified arrangement of the bone fragments can be achieved, in particular, based on user interactions involving moving the bone fragments relative to each other and / or by mirroring a healthy bone segment on the opposite side of the body that corresponds to the bone fragments.

[0038] It is advantageous if, in step b), attachment points and / or axes of fasteners, particularly bone screws, are defined on the bone model for attaching the bone plate to the bone fragments. This allows for the creation of the template design and / or, in the subsequent step c), the template itself, with guide channels corresponding to these attachment points and / or axes. The template can then be used surgically to guide a drill and / or fasteners, usually bone screws, to the bone fragments via these guide channels, according to the attachment points and / or axes, when fixing the bone plate to the bone fragments.It has proven effective to design the template with guide channels so that each guide channel corresponds to a specific opening in the bone plate, in a state adapted to the bone model. This allows the fastening element, particularly the bone screw, to be guided through the opening in the bone plate via the guide channel when the template is positioned on the bone plate. The template is then often referred to as a drilling template.

[0039] In step c) of the process, the stencil is 3D printed, usually using a 3D printer, based on the determined stencil design. The stencil is typically made of a biocompatible and sterilizable material. The stencil can be designed with the aforementioned guide channels. The respective guide channel can be formed at least partially, preferably entirely, during the 3D printing process and / or can be created after 3D printing by removing stencil material, for example, by drilling the guide channel. This is usually done as part of step c).

[0040] Typically, after step c), the bone plate is deformed, in particular bent, based on the shape of the template. Usually, at least a section of the bone plate is adapted to the shape of the template. This can be done by one person, for example, the surgeon. This can be done as part of the procedure in step d).

[0041] In step e), during a surgical procedure, the bone plate used to treat the fracture can be attached to the bone fragments. This attachment is typically achieved using fasteners, usually bone screws, which are inserted through openings in the bone plate and connected to the bone fragments, specifically by screwing them into the plate. It is advantageous to drill holes into the bone fragments for this purpose, and then insert the fasteners through the bone plate into these holes.To facilitate drilling the holes and / or inserting the screws, the template can be positioned in front of the bone fragments, allowing the template's guide channel to act as a guide. This guides the drill bit and / or fastener to be aligned with the bone fragment along the guide channel's axis. The guide channel axis typically corresponds to the orientation of the respective fastening axis, which was defined in step b) based on the bone model. Specifically, the template can be designed with guide channels such that it can be positioned on the bone plate to guide the drill bit and / or fastener through the guide channel and an opening in the bone plate corresponding to the guide channel, directing it towards the respective bone fragment.

[0042] In this way, the template can be manufactured to be patient-specific with high practicality and, in particular, a bone plate corresponding to the template can be adapted to the respective bone fracture with minimal effort.

Claims

Patent claims 1. A method for manufacturing a template for a bone plate for treating a fracture of a bone in a human or animal, in particular for a bone plate for treating a pelvic fracture in a human, wherein a digital data set of an image of bone fragments of the fracture is obtained using an imaging technique, in particular MRI or CT or X-ray imaging, the method comprising the following steps: a) creating a digital, in particular virtual, three-dimensional bone model of the bone fragments based on the data set; b) determining a digital template design adapted to the bone model; c) manufacturing, in particular 3D printing, the template based on the determined template design.

2. Method according to claim 1, characterized in that in step b) the template design is determined, in particular calculated, based on design parameters of an initial design of a template type and / or an initial design of a bone plate type.

3. Method according to claim 1 or 2, characterized in that in step b) a digital, in particular virtual, three-dimensional template model and / or a digital, in particular virtual, three-dimensional bone plate model, which are adapted based on the bone model, are generated to determine the template design.

4. Method according to claim 3, characterized in that the template model and / or the bone plate model is manipulated by deformation, in particular bending, preferably depending on user interactions, in order to adapt the template model and / or bone plate model to the bone model.

5. Method according to any one of claims 1 to 4, characterized in that the bone model, and preferably the template model and / or A bone plate model is visualized in a virtual environment, particularly an interactive one.

6. Method according to one of claims 1 to 5, characterized in that in step b) reference points relative to the bone model can be defined and / or manipulated with user interactions in order to determine the template design depending on the reference points and in particular to generate the template model and / or bone plate model depending on the reference points.

7. Method according to claims 1 to 6, characterized in that in step b) the bone fragments of the bone model are generated in an adapted arrangement with a reduced fracture distance or in a composite form of the bone fragments in order to determine the template design adapted to the adapted arrangement.

8. Method according to claim 7, characterized in that the adapted arrangement of the bone fragments of the bone model is generated by a mirroring of a healthy bone section corresponding to the bone fragments of a body half other than the bone fragments.

9. Method according to one of claims 1 to 8, characterized in that in step b) attachment points and / or attachment axes of fastening elements, in particular bone screws, are defined on the bone model for attaching the bone plate to the bone fragments in order to form the template design and / or the template with guide channels corresponding to the attachment points and / or attachment axes.

10. Method according to claim 9, characterized in that the template is designed with the guide channels such that the respective guide channel corresponds to a respective opening of the bone plate, in a state of the bone plate adapted to the bone model, in order to guide a fastening element, in particular a bone screw, through the opening of the bone plate via the guide channel when the template is arranged on the bone plate.

11. Method according to one of claims 1 to 10, characterized in that in step b) the template design is adapted to correspond to a section of one of the bone fragments or to sections of the bone fragments of the bone model in such a way that the template can be applied to one or more of the bone fragments by forming a positive fit in order to apply a tensile force to the bone fragment with the template or to hold the bone fragments in position relative to each other.

12. Device for data processing, comprising means, in particular at least one processor, which are adapted to perform steps a) and b) of the method according to any one of claims 1 to 11.

13. System for manufacturing a template for a bone plate for treating a fracture of a bone of a human or animal, in particular for a bone plate for treating a pelvic bone fracture of a human, comprising the data processing device according to claim 12, which is configured to perform steps a) and b), and a manufacturing device, in particular a 3D printer, which is configured to perform step c) of the method according to any one of claims 1 to 11.

14. Computer program product comprising instructions that cause the data processing device of claim 12 to perform steps a) and b) or the system of claim 13 to perform steps a) to c) according to any one of claims 1 to 11.

15. Computer-readable storage medium on which the computer program product according to claim 14 is stored.

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