Method for manufacturing a hip implant, individualized hip implant

Abstract

The invention relates to a method for manufacturing a hip implant (20), the method comprising the following: providing a patient information data set (72), which comprises information relating to a shape of a hip bone (10) with an acetabular defect (11), generating a shape data set (76), which comprises information relating to a target shape for a hip implant for the acetabular defect, with the target shape having an individual component (32, 38, 44, 54), the dimensions and / or arrangement of which are characterized by at least one modifiable geometry parameter, and with the generation of the shape data set comprising the definition of the at least one geometry parameter on the basis of the patient information data set, and manufacturing an individualized hip implant on the basis of the shape data set. The invention also relates to an individualized hip implant.

Description

[0001] Title: Method for manufacturing an individualized hip implant

[0002] hip implant

[0003] Description

[0004] The present invention relates to the field of implant technology. In particular, the present invention relates to a method for manufacturing a hip implant and to an individualized hip implant.

[0005] Hip socket defects are extremely heterogeneous. Metallic augmentations and support shells are only available in a limited number of variations and can hardly cover the wide range of possible hip socket defects. Custom hip implants, on the other hand, are expensive and time-consuming to manufacture.

[0006] The invention addresses the problem of providing a hip implant that is highly variable in its shape yet inexpensive and quick to manufacture.

[0007] A first aspect of the description concerns a procedure for manufacturing a hip implant. The procedure includes providing a patient information record that

[0008] The method includes information on a particularly three-dimensional shape of a hip bone with an acetabular defect. The hip bone with the acetabular defect is hereinafter also referred to as the "damaged hip bone." The method further includes generating a shape data set containing information on a particularly three-dimensional target shape for a hip implant for the acetabular defect. The target shape for the acetabular defect comprises an acetabular prosthesis and at least one custom component. A dimension of the custom component and / or an arrangement of the custom component, particularly relative to the acetabular prosthesis, are characterized by at least one variable geometric parameter. The custom component can therefore be modeled parametrically, namely by defining the at least one geometric parameter.Generating the shape data set involves defining at least one geometric parameter based on the patient information data set. The individual component is thus parametrically modeled in relation to the patient information data set. Depending on the patient information data set provided, a different numerical value can be chosen for the at least one geometric parameter, resulting in different dimensions and / or arrangements of the individual component. The process also includes manufacturing an individualized hip implant for the acetabular defect based on the shape data set. The shape of the manufactured individualized hip implant then corresponds to, or closely approximates, the target shape for the hip implant.

[0009] The inventors recognized that the underlying problem is solved by the aforementioned method. Parametric modeling of the individual component allows for sufficient customization, enabling the target shape of the hip implant to be adapted to the acetabular defect. At the same time, the manufacturing time for the hip implant is short, as the scope of customization is clearly defined. This also has the advantage of making approval of the hip implant as a customized, mass-produced implant possible.

[0010] By defining at least one geometric parameter, the dimensions and / or arrangement of the custom component can be adapted to the acetabular defect. Preferably, the at least one geometric parameter is defined such that the contact area between the custom component and the acetabular defect is enlarged, in particular maximized. Enlarging or maximizing the contact area has a beneficial effect on the osseointegration of the femur to the manufactured and implanted hip implant.

[0011] In the context of the disclosure, "setting a geometry parameter" refers to the selection of a numerical value for the geometry parameter.

[0012] In some embodiments, the dimensions and / or arrangement of the individual component are characterized by several variable geometric parameters. Preferably, the dimensions of the individual component are characterized by at least one first variable geometric parameter, and the arrangement of the individual component is characterized by at least one second geometric parameter. The method then comprises defining the several geometric parameters, in particular the at least one first geometric parameter and the at least one second geometric parameter, depending on the patient information data set.

[0013] The at least one first geometric parameter can include a geometric parameter that characterizes the length of the individual component and / or a geometric parameter that characterizes the width of the individual component. The at least one second geometric parameter can include a geometric parameter that characterizes the location where the individual component is connected to the acetabular prosthesis and / or a geometric parameter that characterizes the orientation of the individual component relative to the acetabular prosthesis.

[0014] Preferably, the individual component has at least one three-dimensional geometric figure, wherein a dimension and / or an arrangement of the geometric figure are characterized by the at least one variable geometric parameter.

[0015] The custom component is connected to the acetabular cup prosthesis. In some embodiments, the custom component is directly connected to the acetabular cup prosthesis. In other embodiments, the custom component is indirectly connected to the acetabular cup prosthesis, for example, by a non-customizable additional component. An acetabular cup prosthesis is a hip implant component that includes a hollow spherical receptacle for a femoral head or a femoral head prosthesis. The axis of rotation of an acetabular cup prosthesis passes through one pole of the hollow spherical receptacle and is oriented perpendicular to an opening plane of the receptacle.

[0016] In some embodiments, generating the shape data set includes defining a dimension of the acetabular cup prosthesis based on the patient information data set. For example, the diameter of the socket is defined based on the patient information data set.

[0017] In some embodiments, the target shape of the hip implant has a structured surface, at least in some areas. This can improve the osseointegration of the femur to the manufactured and implanted hip implant. The structured surface can, for example, have teeth, grooves, or a grid structure. A suitable grid structure is known, for example, as a "Structan Surface." In particular, only the acetabular cup prosthesis or only the individual component has the structured surface. However, the entire bone-contact surface of the hip implant can also have the structured surface.

[0018] Within the context of the disclosure, the term "bone contact surface" refers to the part of the surface of the intended shape which, when the intended shape is arranged as intended in the acetabular defect of the damaged hip bone, comes into contact with the hip bone.

[0019] The patient information record can contain, for example, information from an X-ray examination or a computed tomography scan.

[0020] In some preferred embodiments, a limiting data set with limit values ​​for the at least one geometry parameter is provided. The at least one geometry parameter is then defined within these limit values ​​depending on the patient information data set. The limiting data set thus restricts the variability with regard to the selection of a numerical value for the geometry parameter. This restriction of variability can facilitate the approval of the hip implant as a customized, mass-produced implant.

[0021] In some preferred embodiments, the at least one variable geometric parameter is designed to be variable only incrementally. This further limits the variability. This limitation can also facilitate the approval of the hip implant as a customized, mass-produced implant. In some other embodiments, the at least one geometric parameter is continuously variable. It is also possible that, with multiple variable geometric parameters, at least one of the geometric parameters is variable only incrementally, while at least one other geometric parameter is continuously variable.

[0022] In some preferred embodiments, the generation of the shape data set involves selecting one or more individual components from a group comprising various possible individual components, depending on the patient information data set. Thus, the patient information data set determines which individual component(s) represent the desired shape. Depending on the patient information data set, a different individual component or components can be selected. This increases the adaptability of the hip implant to the acetabular defect. Possible individual components are explained in more detail below.

[0023] In some preferred embodiments, the target shape is provided to have at least one defect filler as an individual component. The defect filler is preferably defined parametrically such that, when the target shape is arranged as intended, it fills the acetabular defect of the damaged femur as completely as possible. This allows the contact area between the manufactured and implanted hip implant and the femur to be increased. Various shapes of the defect filler are possible. Preferably, the defect filler is elongated. Preferably, the defect filler is arranged on the acetabular prosthesis such that a longitudinal axis of the defect filler intersects the axis of rotation of the acetabular prosthesis.In some preferred embodiments, the defect filler comprises a cylinder, in particular a circular cylinder or an elliptical cylinder, or a cylinder segment, in particular a circular cylinder segment or a cylinder segment of an elliptical cylinder. A dimension and / or an arrangement of the cylinder or cylinder segment are then characterized by at least one variable geometric parameter, and generating the shape data set includes defining this at least one geometric parameter depending on the patient information data set. A cylinder or a cylinder segment can be well adapted to an acetabular defect due to its rounded shape. A cylinder segment is a part of a cylinder obtained by cutting the cylinder along a cutting plane aligned parallel to the height axis of the cylinder. Preferably, the cylinder or cylinder segment is...The cylinder segment is connected to the acetabular prosthesis in such a way that a vertical axis of the cylinder or cylinder segment intersects the axis of rotation of the acetabular prosthesis. Preferably, a first end face of the cylinder or cylinder segment associated with the acetabular prosthesis is form-fitting to the acetabular prosthesis. For this purpose, the cylinder or cylinder segment may have a rounded recess on its first end face.

[0024] In some preferred embodiments, a dome or dome segment is arranged on an end face of the cylinder or cylinder segment facing away from the acetabular prosthesis. A dome or dome segment eliminates edges in the area of ​​this end face, thus improving the biocompatibility of the implanted hip implant. Depending on the shape of the cylinder or cylinder segment, a different dome or dome segment may be used. For example, if the cylinder is circular, the dome is preferably a spherical cap. Conversely, if the cylinder is elliptical, the dome is preferably an elliptical dome.

[0025] If the defect filling is present as a custom component, its dimensions and / or arrangement can be characterized by various variable geometric parameters. Preferably, the at least one variable geometric parameter includes the width of the defect filling. The width of the defect filling can correspond to the diameter of the cylinder or cylinder segment. Preferably, the at least one variable geometric parameter includes the length of the defect filling. Preferably, the at least one variable geometric parameter includes an angle of rotation between the defect filling, in particular a longitudinal axis of the defect filling, and an angular reference of the target shape around the axis of rotation of the acetabular prosthesis. The angular reference can be formed, for example, by a reference structure of the acetabular prosthesis or by another custom component of the target shape.Preferably, the at least one variable geometric parameter comprises an angle of inclination between a longitudinal axis of the defect filling and the opening plane of the receiving opening of the acetabular prosthesis. If the cylinder or cylinder segment is present, the longitudinal axis preferably corresponds to a vertical axis of the cylinder or cylinder segment.

[0026] Preferably, the dimensions and arrangement of the defect filling are characterized by the aforementioned variable geometric parameters, namely the width of the defect filling, the length of the defect filling, the rotation angle, and the inclination angle. Generating the shape data set then includes defining these geometric parameters.

[0027] In some preferred embodiments, the desired shape comprises at least one plate-shaped iliac contact structure as an individual component. If the iliac contact structure is present as an individual component, a dimension and / or arrangement of the iliac contact structure is characterized by at least one variable geometric parameter. Generating the shape data set then includes defining this at least one geometric parameter as a function of the patient information data set. Preferably, this at least one geometric parameter is defined such that, when the desired shape is arranged as intended in the acetabular defect, the iliac contact structure rests against the ilium of the damaged femur. This increases the contact area between the implanted hip implant and the femur, thus facilitating the osseointegration of the femur to the implanted hip implant.Preferably, the plate-shaped iliac contact structure is elongated. This means that the length of the iliac contact structure is greater than its width. The plate-shaped iliac contact structure can be present as an alternative or additional component to the defect filling. If the iliac contact structure is present as an individual component, its dimensions and / or arrangement can be characterized by various variable geometric parameters. Preferably, the at least one variable geometric parameter includes the width of the iliac contact structure. Preferably, the at least one variable geometric parameter includes the length of the iliac contact structure. Preferably, the at least one variable geometric parameter includes an angle of rotation between the iliac contact structure and an angle reference of the desired shape around the axis of rotation of the acetabular prosthesis.

[0028] Preferably, the dimensions and arrangement of the iliac contact structure are characterized by the aforementioned geometric parameters, namely the width of the iliac contact structure, the length of the iliac contact structure, and the angle of inclination. Generating the shape data set then includes defining these geometric parameters.

[0029] In some preferred embodiments, the iliac contact structure is directly connected to the defect filling, and in particular only to the defect filling. In these embodiments, the iliac contact structure can have a first longitudinal end associated with the defect filling and a second longitudinal end facing away from the defect filling.

[0030] In some preferred embodiments, the iliac contact structure is directly connected to the acetabular prosthesis, in particular only to the acetabular prosthesis. In these embodiments, the iliac contact structure can have a first longitudinal end associated with the acetabular prosthesis and a second end facing away from the acetabular prosthesis.

[0031] The iliac contact structure can also be directly connected to the acetabular prosthesis and the defect filling. In these embodiments, a first longitudinal end of the iliac contact structure may be arranged on the acetabular prosthesis, and a longitudinal section of the iliac contact structure adjoining the first longitudinal end extends along the defect filling. In some preferred embodiments, the acetabular prosthesis comprises an angled ischial contact structure as a custom component. If the ischial contact structure is present as a custom component, its dimensions and / or arrangement are characterized by at least one variable geometric parameter. Generating the shape data set then includes defining this at least one geometric parameter as a function of the patient information data set.Preferably, at least one geometric parameter is defined such that, when the intended shape is positioned correctly within the acetabular defect, the ischial contact structure rests against the ischium of the damaged hip bone. This increases the contact area between the implanted hip prosthesis and the hip bone, facilitating the osseointegration of the hip prosthesis. Preferably, the ischial contact structure is elongated. Preferably, a first longitudinal end of the ischial contact structure is directly connected to the acetabular prosthesis. Preferably, the ischial contact structure has a first longitudinal section and a second longitudinal section along its length, wherein the first and second longitudinal sections are angled relative to each other.

[0032] If the ischial contact structure is provided as an individual component, its dimensions and / or arrangement can be characterized by various variable geometric parameters. Preferably, the at least one variable geometric parameter comprises the length of the ischial contact structure. Preferably, the at least one variable geometric parameter comprises the width of the ischial contact structure. Preferably, the at least one variable geometric parameter comprises an angle of inclination between the first longitudinal section and the second longitudinal section of the ischial contact structure. The first longitudinal section preferably extends parallel to a plane that is oriented perpendicular to the axis of rotation of the acetabular prosthesis. Preferably, the at least one variable geometric parameter comprises the length of the first longitudinal section of the

[0033] Ischial contact structure. If the length of the ischial contact structure is defined, the length of the second longitudinal section can be implicitly deduced from the length of the first longitudinal section. Preferably, the at least one variable geometric parameter comprises a rotation angle between the ischial contact structure and an angular reference of the desired shape around the axis of rotation of the acetabular prosthesis. Preferably, the dimensions and arrangement of the ischial contact structure are characterized by the aforementioned geometric parameters, i.e., by the width of the ischial contact structure, by the length of the ischial contact structure, by the angle of inclination between the first and second longitudinal sections, by the length of the first longitudinal section, and by the rotation angle between the ischial contact structure and the angular reference. Generating the shape data set then includes defining these geometric parameters.

[0034] In some preferred embodiments, the acetabular prosthesis includes an angled pubic bone contact structure as a custom component. If the pubic bone contact structure is present as a custom component, its dimensions and / or arrangement are characterized by at least one variable geometric parameter. Generating the shape data set then includes defining this at least one geometric parameter based on the patient information data set. Preferably, the at least one geometric parameter is defined such that, when the desired shape is arranged as intended in the acetabular defect, the pubic bone contact structure rests against the pubic bone of the damaged femur. This increases the contact surface between the implanted hip prosthesis and the femur, facilitating the osseointegration of the femur to the hip implant. Preferably, the pubic bone contact structure is elongated.

[0035] Preferably, a first longitudinal end of the pubic bone contact structure is directly connected to the acetabular prosthesis. Preferably, the pubic bone contact structure has a first longitudinal section and a second longitudinal section along its longitudinal extent, wherein the first longitudinal section and the second longitudinal section are angled relative to each other.

[0036] If the pubic bone contact structure is present as an individual component, its dimensions and / or arrangement can be characterized by various variable geometric parameters. Preferably, the at least one variable geometric parameter comprises the length of the pubic bone contact structure. Preferably, the at least one variable geometric parameter comprises the width of the pubic bone contact structure. Preferably, the at least one variable geometric parameter comprises an angle of inclination between the first longitudinal segment and the second longitudinal segment of the pubic bone contact structure. The first longitudinal segment preferably extends parallel to a plane that is oriented perpendicular to the axis of rotation of the acetabular prosthesis. Preferably, the at least one variable geometric parameter comprises the length of the first longitudinal segment of the pubic bone contact structure.If the length of the pubic bone contact structure is defined, the length of the second longitudinal section can be implicitly deduced from the length of the first longitudinal section. Preferably, the at least one variable geometric parameter comprises a rotation angle between the pubic bone contact structure and an angular reference of the desired shape around the axis of rotation of the acetabular prosthesis.

[0037] Preferably, the dimensions and arrangement of the pubic bone contact structure are characterized by the aforementioned geometric parameters, namely the width of the pubic bone contact structure, the length of the pubic bone contact structure, the angle of inclination between the first longitudinal section and the second longitudinal section, the length of the first longitudinal section, and the angle of rotation between the pubic bone contact structure and the reference angle. Generating the shape data set then includes defining these geometric parameters.

[0038] In some preferred embodiments, the defect filling includes at least one through-hole. This through-hole can serve to receive a fastening element, such as a screw, and thus enables the manufactured hip implant to be fixed to the iliac bone. Preferably, the through-hole is designed as an elongated slot.

[0039] Preferably, the dimensions and / or arrangement of the through-opening in the defect filling are characterized by at least one variable geometric parameter. Generating the shape data set then includes defining this at least one geometric parameter as a function of the patient information data set. If the through-opening is present in the defect filling, its dimensions and / or arrangement can be characterized by various variable geometric parameters. Preferably, the at least one variable geometric parameter includes a radial distance between the through-opening in the defect filling and the axis of rotation of the acetabular prosthesis. Preferably, the at least one variable geometric parameter includes a rotation angle between the through-opening and an angular reference of the desired shape around the axis of rotation of the acetabular prosthesis.Preferably, the at least one variable geometric parameter comprises an angle of inclination between an axis extending in the opening direction of the through-hole and a plane that is oriented perpendicular to the axis of rotation of the acetabular prosthesis. If the through-hole is designed as an elongated hole, the at least one variable geometric parameter preferably comprises the length of the elongated hole.

[0040] In some preferred embodiments, the acetabular cup prosthesis includes at least one through-hole. This through-hole can accommodate a fastening element, such as a screw, thereby enabling additional fixation of the manufactured hip implant to the iliac bone. The through-hole can be designed as an elongated hole or as a through-hole with a circular cross-section. Multiple through-holes may also be present in the acetabular cup prosthesis.

[0041] Preferably, the dimensions and / or arrangement of the through-hole in the acetabular prosthesis are characterized by at least one variable geometric parameter. Generating the shape data set then includes defining this at least one geometric parameter as a function of the patient information data set. Preferably, the at least one variable geometric parameter comprises a rotation angle between the through-hole in the acetabular prosthesis and an angular reference of the desired shape around the axis of rotation of the acetabular prosthesis.

[0042] In some preferred embodiments, a reference information dataset is provided, which includes information on the shape, particularly the three-dimensional shape, of a healthy hip bone. Specifically, the shape of the healthy hip bone described by the reference information dataset is scaled to the shape of the injured hip bone described by the patient information dataset and aligned with the shape of the injured hip bone.

[0043] Preferably, generating the shape data set includes an anatomical adaptation of a bone-remote section of the defect filler based on the reference information data set. This anatomical adaptation takes place after defining at least one geometry parameter associated with the defect filler. By anatomically adapting the defect filler, it can be ensured that, during the intended implantation of the manufactured hip implant, the filler only occupies the area where bone tissue is present in a healthy iliac crest. In particular, the anatomical adaptation of the defect filler first generates a combined data set in which the scaled and aligned shape of the healthy iliac crest and the shape of the damaged iliac crest are superimposed.Of the portion of the defect filler furthest from the bone, only the part that is overlaid by the shape of the healthy iliac bone is retained, as intended within the acetabular defect. The course of the furthest surface of the defect filler therefore corresponds to the course of the corresponding surface of the healthy iliac bone.

[0044] Preferably, generating the shape data set includes an anatomical adaptation of the curvature of the iliac contact structure based on the reference information data set. This anatomical adaptation takes place after defining the at least one geometry parameter associated with the iliac contact structure. By anatomically adapting the iliac contact structure, it can be ensured that, with the implanted hip implant, the iliac contact structure extends along the ilium of the femur and, in particular, along the anatomically adapted defect filling. Specifically, the anatomical adaptation of the iliac contact structure includes projecting the iliac contact structure onto the scaled and aligned shape of the healthy femur. The resulting projection surface is then thickened to create the anatomically adapted iliac contact structure.The adapted iliac contact structure then extends, when the intended shape is arranged as intended, along the ilium of the injured hip bone in the acetabular defect of the injured hip bone and, in particular, along the anatomically adapted defect filling.

[0045] In some preferred embodiments, the hip implant is manufactured using an additive manufacturing process. Additive manufacturing allows for the precise realization of the desired shape. Furthermore, it can easily accommodate high variability. Preferably, the hip implant is manufactured by selective laser melting, particularly preferably from a titanium alloy.

[0046] In some preferred embodiments, the hip implant is manufactured as a monoblock implant. The components of the desired shape, i.e., the acetabular cup prosthesis and the individual component(s), are therefore different areas within the same one-piece structure of the manufactured hip implant. Preferably, the hip implant is manufactured as a monoblock implant using an additive manufacturing process.

[0047] Alternatively, individual parts for the hip implant can also be manufactured separately and then attached to each other to form the customized hip implant.

[0048] The procedure of the first aspect can be implemented in various approaches with regard to the development and manufacturing process.

[0049] In a first approach, the target shape is selected from a large number of predefined variants, also known as the "design envelope," with the selection of one of the variants being based on the patient information dataset. The number of possible variants (i.e., the "design envelope") can, for example, be at least 10,000 variants, significantly exceeding the number of available variants of a standard implant. The geometric parameters and their values ​​of the selected variant are used for the manufacturing of the hip implant and in the surgical procedure. A particularly preferred approach for this first step is as follows:

[0050] First, the "design envelope" is defined. This involves defining the geometric parameters, parameter limits, and rules of a general hip implant. The "design envelope" contains all possible variations of the hip implant. Preoperative planning then takes place. Based on the patient information record, the specific values ​​of the individual geometric parameters are determined. Using the defined geometric parameters and rules of the "design envelope" from the preoperative planning, a specific hip implant variant is then selected. This is followed by the fabrication of the selected hip implant variant. The specific values ​​of the geometric parameters of the selected or fabricated hip implant variant are used intraoperatively for preparing the iliac bone and inserting the hip implant.

[0051] In a second approach, the target shape for the hip implant is defined based on the patient information dataset without prior definition of a "design envelope" containing a limited number of possible variants. In contrast to the first approach, the target shape is therefore only defined after its design. A preferred procedure for the second approach is as follows:

[0052] As part of the preoperative planning, the target shape for the hip implant is designed based on the patient information data set, using geometric parameters and shapes, but without a design template. The hip implant is then manufactured according to the preoperative plan, based on the defined geometric parameters and shapes. The specific dimensions of the hip implant are used intraoperatively for preparing the iliac bone and inserting the implant.

[0053] A second aspect of the description concerns a customized hip implant. The customized hip implant comprises a hip socket prosthesis and at least one customized component connected to the hip socket prosthesis. A dimension of the customized component and / or an arrangement of the customized component, particularly relative to the hip socket prosthesis, are defined by at least one specified geometric parameter. Preferably, the customized hip implant is manufactured by a method as described above.

[0054] Regarding the advantages achievable with the individualized hip implant, reference is made to the corresponding explanations of the procedure. The features described in connection with the procedure can serve as a basis for further developing the individualized hip implant. In particular, the individual components discussed in connection with the procedure, namely the defect filling, the iliac contact structure, the ischial contact structure, and / or the pubic contact structure, can be present. A third aspect of the description concerns an individualized hip implant for a hip bone with an acetabular defect.

[0055] The hip implant includes a hip socket prosthesis. A hip socket prosthesis is a component of the hip implant that comprises a hollow, spherical socket for a femoral head or a femoral head prosthesis.

[0056] The hip implant also comprises one or more individual components. As an individual component, the hip implant includes at least one defect filler. The defect filler has a bone contact surface for contacting the iliac crest. When the hip implant is implanted as intended, the bone contact surface faces the iliac crest and is in direct contact with it. The bone contact surface of the defect filler has, at least in part, the shape of a cylindrical surface segment. This underlying cylinder can be, for example, a circular cylinder or an elliptical cylinder. A cylindrical surface segment refers to a section of the curved surface of the cylinder.

[0057] A bone contact surface shaped in this way allows for advantageous contact between the hip implant and the iliac bone, which can lead to stable anchoring of the hip implant. As previously described in connection with the first aspect, there are also advantages regarding the determination of the hip implant's shape. A cylindrical surface segment can be described by various geometric parameters, in particular by the height of the underlying cylinder, the diameter of the underlying cylinder, and / or the segment angle over which the cylindrical surface segment extends. Specifically, the defect filling is elongated. Depending on the diameter and height of the underlying cylinder, however, the defect filling can also be squat.

[0058] The features described in connection with the first aspect can be used to further customize the individualized hip implant. For example, the hip implant can have one or more additional individualized components. The hip implant, particularly the acetabular prosthesis and / or an individualized component, can have one or more drill holes.

[0059] In addition to the bone-contact surface, the defect filler has a surface facing away from the bone. The shape of the surface facing away from the bone is preferably anatomically adapted so that its course corresponds to the course of the corresponding surface of a healthy hip bone.

[0060] In some preferred embodiments, the defect filling extends away from the acetabular prosthesis and has a dome or dome segment at its end facing away from the prosthesis. A dome or dome segment eliminates edges in the region of this end, which has a beneficial effect on the biocompatibility of the implanted hip implant. Depending on the shape of the underlying cylinder, a different dome or dome segment may be present. For example, if the cylinder is circular, the dome is preferably a spherical cap, or the dome segment is a spherical cap segment. If, on the other hand, the cylinder is elliptical, the dome is preferably an elliptical dome, or the dome segment is an elliptical dome segment.

[0061] In some preferred embodiments, the hip implant is provided to have, as an individual component, a plate-shaped iliac contact structure, an angled ischial contact structure, and / or an angled pubic contact structure. This results in the advantages discussed in connection with the first aspect. The features described in connection with the first aspect can serve to further develop the aforementioned individual components.

[0062] In some preferred embodiments, the individualized hip implant is designed as a monoblock implant.

[0063] The invention will be explained in more detail below with reference to the drawings. These show:

[0064] Figure 1 is a three-dimensional model of a healthy hip bone; Figure 2 is a three-dimensional model of a damaged hip bone with a

[0065] Hip socket defect;

[0066] Figure 3 shows a nominal shape for a hip implant for acetabular defect according to an exemplary embodiment;

[0067] Figure 4 shows a side view of the desired shape shown in Figure 3;

[0068] Figure 5 shows perspective views of the target shape shown in Figure 3;

[0069] Figure 6 shows a target shape for a hip implant according to another

[0070] Example implementation;

[0071] Figure 7 shows a detailed view of the target shape shown in Figure 6;

[0072] Figure 8 shows a method for manufacturing an individualized hip implant; and

[0073] Figures 9a-9d show aspects of the procedure shown in Figure 8.

[0074] Figure 1 shows a three-dimensional form of a healthy hip bone 10. The hip bone 10 comprises, in a known manner, an intact or defect-free acetabulum 12, an ilium 14, a pubic bone 16 and an ischium 18.

[0075] Figure 2 shows a three-dimensional model of a damaged hip bone 10 of a patient. The acetabulum 12 of the hip bone 10 shown in Figure 2 exhibits a pronounced acetabular defect 11.

[0076] Figures 3-5 show an embodiment of a target shape for a hip implant 20 for the acetabular defect 11. The target shape was adapted to the damaged hip bone 10 shown in Figure 2, or rather to its acetabular defect 11, as part of an in-silico adaptation, i.e., an adaptation at the data set level.

[0077] The target shape for the hip implant 20 includes a hip socket prosthesis 22.

[0078] The acetabular cup prosthesis 22 is hemispherical and includes a receptacle 24. A femoral head or a femoral head prosthesis can be positioned in the receptacle 24. The axis of rotation 26 of the acetabular cup prosthesis 22 runs through the pole 28 of the acetabular cup prosthesis 22 and is oriented perpendicular to the opening plane of the receptacle 24.

[0079] The target shape for the hip implant 20 comprises, in addition to the acetabular prosthesis 22, at least one customized component. In the embodiment shown in Figures 3-5, a defect filler 32 is provided as the customized component. In the present embodiment, the defect filler 32 is directly connected to the acetabular prosthesis 22. The dimensions of the defect filler 32 and its arrangement relative to the acetabular prosthesis 22 can be defined parametrically, i.e., by specifying numerical values ​​for geometric parameters. This will be explained in more detail later in connection with a method for manufacturing the hip implant 20.

[0080] In the embodiment shown in Figures 3-5, a through-opening 34 for a fastening element is provided in the defect filling 32. In this case, the through-opening 34 is designed as an elongated hole 34. The through-opening 34 enables the manufactured hip implant 20 to be fixed to the iliac bone 10. The design of the through-opening 34 will be explained in more detail in connection with the method.

[0081] In the embodiment shown in Figures 3-5, the acetabular cup prosthesis 22 also has several through-openings 36 for fastening elements. Specifically, there is one elongated through-opening 36A, i.e., a slotted hole 36A, and two circular through-openings 36B. The design of the through-openings 36 will be explained in more detail in connection with the method.

[0082] In the embodiment shown in Figures 3-5, the surface of the target shape for the hip implant 20 is partially structured. In this example, only the bone-contacting surface of the acetabular cup prosthesis 22 is structured. However, the defect filling 32 can also have a structured surface, particularly in the area of ​​its bone-contacting surface. Figures 6 and 7 show a target shape for a hip implant 20 according to a further embodiment. The target shape shown in Figures 6-8 differs from the target shape shown in Figures 3-5 in that it has additional individual components.

[0083] The target shape shown in Figures 6 and 7 features an additional individual component: a plate-shaped iliac contact structure 38. In this case, the iliac contact structure 38 is directly connected to the defect filling 32. Extending from the defect filling 32, the iliac contact structure 38 moves away from the acetabular prosthesis 22. A first longitudinal end 40 of the iliac contact structure 38 is located at the defect filling 32. A second longitudinal end 42 of the iliac contact structure 38 is spaced apart from the defect filling 32. The dimensions of the iliac contact structure 38 and its arrangement relative to the acetabular prosthesis 22 can be defined parametrically, i.e., by specifying numerical values ​​for geometric parameters. This will be explained in more detail later in connection with the manufacturing process.

[0084] The target shape shown in Figures 6 and 7 also features an angled pubic bone contact structure 44 as an additional individual component. A first longitudinal end 46 of the pubic bone contact structure 44 is directly connected to the acetabular prosthesis 22. Extending from the acetabular prosthesis 22, the pubic bone contact structure 44 extends away from the acetabular prosthesis 22, such that a second longitudinal end 48 of the pubic bone contact structure 44 is spaced apart from the acetabular prosthesis 22.

[0085] As can be seen from Figure 7, the pubic bone contact structure 44 has a straight first longitudinal section 50 and a straight second longitudinal section 52. The longitudinal sections 50 and 52 are oriented at an angle to each other.

[0086] The dimensions of the pubic bone contact structure 44 and its arrangement relative to the acetabular prosthesis 22 can be defined parametrically, i.e., by specifying numerical values ​​for geometry parameters. This will be explained in more detail later in connection with the manufacturing process. The target shape shown in Figures 6 and 7 also features an angled ischial bone contact structure 54 as an additional individual component. A first longitudinal end 56 of the ischial bone contact structure 54 is directly connected to the acetabular prosthesis 22. Extending from the acetabular prosthesis 22, the ischial bone contact structure 54 is spaced away from the acetabular prosthesis 22, such that a second longitudinal end 58 of the ischial bone contact structure 54 is spaced away from the acetabular prosthesis 22.

[0087] The ischial contact structure 54 also has a first longitudinal section 60 and a second longitudinal section 62, which are oriented at an angle to each other.

[0088] The dimensions of the ischial contact structure 54 and its arrangement relative to the acetabular prosthesis 22 can be defined parametrically, i.e., by specifying numerical values ​​for geometry parameters. This will be explained in more detail later in connection with the manufacturing process.

[0089] The following section describes a method for manufacturing a customized hip implant 20 with reference to Figures 8 and 9. For the sake of example, the method produces a customized hip implant 20 whose shape corresponds to the target shape shown in Figures 3-5. However, it is equally possible to manufacture a hip implant whose shape corresponds to the target shape shown in Figures 6 and 7.

[0090] In a first step S101, a patient information data set 72 is provided, which describes a three-dimensional shape of a patient's hip bone. In the present embodiment, the patient information data set 72 describes the damaged hip bone 10 shown in Figure 2.

[0091] In a second step S103, the diameter of the receptacle 24 of the acetabular prosthesis 22 is determined based on the patient information data set 72. This step of the procedure is visualized in Figure 9a. The acetabular prosthesis 22 of the target shape is essentially fitted into the acetabular defect 11. In a third step S105, the dimensions and arrangement of the defect filling 32 are adapted to the existing acetabular defect 11. This step of the procedure is visualized in Figure 9b. The defect filling 32 initially has a cylinder 64 that extends away from the acetabular prosthesis 22. A dome 68 is arranged at a longitudinal end 64 of the cylinder 64 that is spaced apart from the acetabular prosthesis 22. Adapting the defect filling 32 to the acetabular defect 11 involves a parametric definition of the defect filling 32 based on the patient information data set 72.The dimensions and arrangement of the defect filling 32 are thus defined by specifying several variable geometric parameters. In the present embodiment, the following variable geometric parameters are provided.

[0092] The first geometric parameter assigned to the defect filling 32 is the diameter of the cylinder 64. The second geometric parameter assigned to the defect filling 32 is the length of the defect filling 32. The dimensions of the defect filling 32 can be defined by the first and second geometric parameters.

[0093] A third geometric parameter associated with the defect filler 32 is the angle of rotation between the defect filler 32 and an angular reference 70 of the desired shape about the axis of rotation 26 of the acetabular prosthesis 22. In the present embodiment, the angular reference 70 is a corner of a recess in the acetabular prosthesis 22. Alternatively, another structure can serve as the angular reference for the angle of rotation. A fourth geometric parameter associated with the defect filler 32 is the angle of inclination between a height axis of the cylinder 64 and a plane that is oriented perpendicular to the axis of rotation 26 of the acetabular prosthesis 22. The arrangement of the defect filler 32 relative to the acetabular prosthesis 22 can be defined by the third and fourth geometric parameters.

[0094] In a fourth step S107, a reference information data set 80 is provided, which describes a three-dimensional shape of a healthy hip bone 10. In the present embodiment, the reference information data set 80 describes the healthy hip bone 10 shown in Figure 1. In a fifth step S109, the shape of the healthy hip bone 10 described by the reference information data set 80 is scaled to the shape of the injured hip bone 10 and aligned with the injured hip bone 10. This results in a combination data set 86 in which the scaled and aligned shape of the healthy hip bone 10 and the shape of the injured hip bone 10 are superimposed.

[0095] In a sixth step S111, a bone-facing section of the defect filler 32 is anatomically adapted. For this purpose, the target shape is positioned as intended within the acetabular defect 11 according to the shape of the damaged iliac bone 10, and only the portion of the defect filler 32 that is superimposed by the shape of the healthy iliac bone 10 is retained. In other words, the portion of the defect filler 32 where the aligned and scaled shape of the healthy iliac bone 10 does not superimpose the defect filler 32 is removed. This step of the procedure is visualized in Figure 9c. By anatomically adapting the bone-facing section of the defect filler 32, the transition from the bone-facing surface 74 of the defect filler 32 to the surrounding surface of the damaged iliac bone 10 can be improved in the manufactured and implanted hip implant 20. In particular, a seamless transition can be achieved.

[0096] In a seventh step, S113, a decision is made, based on the patient information record 72, as to whether one or more additional individual components, such as the iliac contact structure 38, the ischial contact structure 54, and / or the pubic contact structure 44, should be added to the target shape. In this case, it is decided that none of these individual components should be added to the target shape.

[0097] However, if in the seventh step S113 it is decided that one or more further individual components should be added, the dimensions and arrangement of these individual components are parametrically modeled as explained below, depending on the patient information data set.

[0098] If the iliac contact structure 38 is added as an individual component, its dimensions and arrangement are defined by the following variable geometric parameters. A first geometric parameter assigned to the iliac contact structure is its length. A second geometric parameter assigned to the iliac contact structure is its width. A third geometric parameter assigned to the iliac contact structure 38 is the angle of rotation between the iliac contact structure 38 and an angular reference 70, in particular the corner of the recess, about the axis of rotation 26 of the acetabular prosthesis 22. In the case of the iliac contact structure 38, the aforementioned geometric parameters are determined based on the patient information data set 72 such that, when the iliac contact structure 38 is positioned in the acetabular defect 11 in its intended shape, it rests against the ilium 14 of the damaged femoral bone 10.

[0099] If the iliac contact structure 38 is present as an individual component, an anatomical adjustment of the curvature of the iliac contact structure 38 is performed following the determination of the geometric parameters. For this purpose, the iliac contact structure 38 is projected onto the scaled and aligned form of the healthy hip bone 10. The resulting projection surface is then thickened to obtain the anatomically adapted iliac contact structure 38.

[0100] If the ischial contact structure 54 is added as an individual component, its dimensions and arrangement are defined by the following variable geometric parameters. The first geometric parameter assigned to the ischial contact structure 54 is its length. The second geometric parameter assigned to the ischial contact structure 54 is its width. The third geometric parameter assigned to the ischial contact structure 54 is the angle of inclination between the first longitudinal section 60 of the ischial contact structure 54 and the second longitudinal section 62 of the ischial contact structure 54. The fourth geometric parameter assigned to the ischial contact structure 54 is the length of the first longitudinal section 60 of the ischial contact structure 54. The length of the first longitudinal section 60 of the ischial contact structure 54 corresponds to the distance of the acetabular prosthesis 22 from the curvature between the two longitudinal sections.A fifth geometric parameter assigned to the ischial contact structure 54 is the rotation angle between the ischial contact structure 54 and an angular reference 70, in particular the corner of the recess, about the rotation axis 26 of the acetabular prosthesis 22. In the case of the ischial contact structure 54, the aforementioned geometric parameters are determined depending on the patient information data set 72 such that the ischial contact structure 54, when arranged in the acetabular defect 11 as intended, rests against the ischium 18 of the damaged hip bone 10.

[0101] If the pubic bone contact structure 44 is added as an individual component, its dimensions and arrangement are defined by the following variable geometric parameters. A first geometric parameter assigned to the pubic bone contact structure 44 is its length. A second geometric parameter assigned to the pubic bone contact structure 44 is its width. A third geometric parameter assigned to the pubic bone contact structure 44 is the angle of inclination between the first longitudinal section 50 of the pubic bone contact structure 44 and the second longitudinal section 52 of the pubic bone contact structure 44. A fourth geometric parameter assigned to the pubic bone contact structure 44 is the length of the first longitudinal section 50 of the pubic bone contact structure 44.The length of the first longitudinal section 50 of the pubic bone contact structure 44 corresponds to the distance of the acetabular prosthesis 22 from the curvature between the two longitudinal sections 50 and 52 of the pubic bone contact structure 44. A fifth geometric parameter assigned to the pubic bone contact structure 44 is the rotation angle between the pubic bone contact structure 44 and an angular reference 70, in particular the corner of the recess, about the rotation axis 26 of the acetabular prosthesis 22. In the case of the pubic bone contact structure 44, the aforementioned geometric parameters are determined depending on the patient information data set 72 such that the pubic bone contact structure 44, when arranged in the intended shape in the acetabular defect 11, rests against the pubic bone 16 of the damaged iliac bone 10.

[0102] In an eighth step S115, depending on the patient information data set 72, a decision is made as to whether the defect filling 32 and / or the acetabular prosthesis 22 should be equipped with one or more through-openings.

[0103] In the present embodiment, it is decided that the defect filling 32 is to be equipped with the through-opening 34. The dimensions and arrangement of the through-opening 34 are defined by the following variable geometric parameters. A first geometric parameter associated with the through-opening 34 is the radial distance between the through-opening 34 and the axis of rotation 26 of the acetabular prosthesis 22. A second geometric parameter associated with the through-opening 34 is the angle of rotation between the through-opening 34 and an angular reference 70, in particular the corner of the recess, about the axis of rotation 26 of the acetabular prosthesis 22. A third geometric parameter associated with the through-opening 34 is the angle of inclination between an axis extending in the opening direction of the through-opening 34 and a plane that is oriented perpendicular to the axis of rotation 26 of the acetabular prosthesis 22.If the through-opening 34 is designed as an elongated hole, then a fourth geometric parameter assigned to the through-opening 34 is the length of the elongated hole.

[0104] In the present embodiment, it is also decided that the acetabular prosthesis 22 is to be equipped with the through-openings 36. With regard to the through-openings 36, only the arrangement can be defined parametrically in this case. The only variable geometric parameter associated with the through-openings 36 is the rotation angle between the through-openings 36 and an angular reference 70, in particular the corner of the recess, about the axis of rotation 26 of the acetabular prosthesis 22.

[0105] Through the above-described procedural steps, in a ninth step S117 a form data set 76 is finally obtained, which describes the target shape for the hip implant 20 for the acetabular defect 11.

[0106] In a tenth step, S119, the patient information data set 72 is adapted depending on the target shape for the hip implant 20. This step of the procedure is visualized in Figure 9d. For this purpose, the shape of the damaged iliac bone 10 described by the patient information data set 72 is modified with radii 82 and through-holes 84 for fastening elements. This results in an adapted patient information data set 78, which describes the adapted shape of the iliac bone 10. During the implantation of the manufactured hip implant 20, bone material is removed from the patient's damaged iliac bone 10 according to the adapted patient information data set 78 in order to prepare the iliac bone 10 for the implantation of the hip implant 20.

[0107] In an eleventh step, S121, the individualized hip implant 20 for the acetabular defect 11 is manufactured based on the shape data set 76. The shape of the manufactured hip implant 20 then corresponds to the target shape described by the shape data set 76 or is an approximation of the target shape.

[0108] In this embodiment, the hip implant 20 is manufactured as a monoblock implant by an additive manufacturing process, preferably by selective laser melting.

Claims

Patent claims 1. Method for manufacturing a hip implant (20), comprising: - Providing a patient information record (72) that includes information on a form of hip bone (10) with an acetabular defect (11), - Generating a shape data set (76) comprising information on a target shape for a hip implant (20) for the acetabular defect (11), wherein the target shape comprises an acetabular prosthesis (22) and at least one individual component (32, 38, 44, 54), wherein a dimension of the individual component (32, 38, 44, 54) and / or an arrangement of the individual component (32, 38, 44, 54) are characterized by at least one variable geometry parameter, and wherein generating the shape data set (76) comprises setting the at least one geometry parameter depending on the patient information data set (72), and - Manufacturing an individualized hip implant (20) for the acetabular defect (11) depending on the shape data set (76).

2. Method according to claim 1, characterized in that a limiting data set with limit values ​​for the at least one geometry parameter is provided, and that the at least one geometry parameter is determined within the limit values ​​depending on the patient information data set (72).

3. Method according to one of the preceding claims, characterized in that the at least one geometry parameter can only be changed step by step.

4. Method according to one of the preceding claims, characterized in that the generation of the form data set (76) comprises selecting only one individual component or several individual components from a group comprising various possible individual components (32, 38, 44, 54) depending on the patient information data set (72).

5. Method according to one of the preceding claims, characterized in that the target shape has at least one defect filling (32) as an individual component.

6. Method according to the preceding claim, characterized in that the defect filling (32) comprises a cylinder (64) or a cylinder segment, wherein a dimension and / or an arrangement of the cylinder (64) or the cylinder segment is characterized by at least one variable geometric parameter.

7. Method according to the preceding claim, characterized in that a dome (68) or a dome segment is arranged on an end face (66) of the cylinder (64) or cylinder segment facing away from the acetabular prosthesis (22).

8. Method according to one of claims 5 to 7, characterized in that it comprises at least one variable geometric parameter: - a width of defect filling (32), - a length of defect filling (32), - a rotation angle between the defect filling (32) and an angle reference (70) about the rotation axis (26) of the acetabular prosthesis (22), and / or - an angle of inclination between a longitudinal axis of the defect filling (32) and a plane that is perpendicular to the axis of rotation (26) of the acetabular prosthesis (22).

9. Method according to one of the preceding claims, characterized in that the desired shape comprises a plate-shaped iliac contact structure (38) as an individual component, wherein a dimension and / or an arrangement of the iliac contact structure (38) are characterized by at least one variable geometric parameter.

10. Method according to the preceding claim, characterized in that it comprises at least one variable geometry parameter: - a width of the iliac contact structure (38), - a length of the iliac contact structure (38) and / or a rotation angle between the iliac contact structure (38) and a Angle reference (70) about the axis of rotation (26) of the acetabular prosthesis (22).

11. Method according to one of claims 9 and 10, characterized in that the iliac contact structure (38) is directly connected to the defect filling (32), and / or that the iliac contact structure (38) is directly connected to the acetabular prosthesis (22).

12. Method according to one of the preceding claims, characterized in that the acetabular prosthesis (22) comprises as an individual component an angled ischial contact structure (54) and / or an angled pubic contact structure (44).

13. Method according to one of claims 5 to 12, characterized in that the defect filling (32) comprises at least one through-opening (34), in particular at least one elongated hole (34).

14. Method according to one of the preceding claims, characterized in that the acetabular prosthesis (22) comprises at least one through-hole (36), in particular at least one elongated hole (36A) and / or at least one circular through-hole (36B).

15. Method according to any one of claims 5 to 14, characterized in that - a reference information dataset (80) is provided which includes information on the shape of a healthy hip bone (10), wherein - the generation of the shape data set (76) includes an anatomical adaptation of a bone-away section of the defect filling (32) depending on the reference information data set (80), and / or wherein - the generation of the shape data set (76) includes an anatomical adaptation of a curvature of the iliac contact structure (38) depending on the reference information data set (80).

16. Method according to one of the preceding claims, characterized in that the individualized hip implant (20) is manufactured by an additive manufacturing process, in particular by selective laser melting.

17. Method according to one of the preceding claims, characterized in that the individualized hip implant (20) is manufactured as a monoblock implant.

18. Individualized hip implant (20), in particular manufactured by a method according to one of the preceding claims, comprising: - a hip socket prosthesis (22), and - at least one individual component (32,38,44,54), wherein a dimension of the individual component (32,38,44,54) and / or an arrangement of the individual component (32,38,44,54) are defined by at least one specified geometric parameter.

19. Individualized hip implant (20) for a hip bone (10) with a hip socket defect (11), comprising the hip implant (20): - a hip socket prosthesis (22); and - one or more individual components (32, 38, 44, 54), wherein - the hip implant (20) as an individual component has at least one defect filling (32), wherein the defect filling (32) has a bone contact surface for contacting the hip bone (10), and wherein the bone contact surface has at least sectionally the shape of a lateral surface segment of a cylinder (64), in particular a circular cylinder or an elliptical cylinder.

20. Individualized hip implant (20) according to the preceding claim, characterized in that the defect filling (32) extends away from the acetabular prosthesis (22) and has a dome (68) or a dome segment at its end facing away from the acetabular prosthesis (22).

21. Individualized hip implant (20) according to one of claims 19 and 20, characterized in that the hip implant (20) has as an individual component a plate-shaped iliac contact structure (38), an angled ischial contact structure (54) and / or an angled pubic contact structure (44).

22. Individualized hip implant (20) according to one of claims 19 to 21, characterized in that the individualized hip implant (20) is designed as a monoblock implant.

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