Attachment; method for manufacturing an attachment; and method for selecting a suitable attachment for at least partially covering a bone defect site

Abstract

The invention relates to an attachment (1), a method for manufacturing an attachment (1), and a method for selecting a suitable attachment (1) for at least partially covering a bone defect site, wherein the attachment (1), in order to at least partially cover a bone defect site, has an extension in a first direction x, in a direction y orthogonal thereto, and in a direction z orthogonal to x and y, and the attachment (1) and / or at least one stiffening element (3) attached to the attachment (1) consists at least in part of a material which exhibits a shape memory effect and / or such a strong restoring force that, after elastic deformation, it returns to its original state.

Description

[0001] Attachment; Method for producing an attachment; Method for selecting a suitable attachment for at least partially covering a bone defect site

[0002] State of the art

[0003] The invention is based on an attachment according to the preamble of claim 1, a method for producing an attachment according to the preamble of claim 10, and a method for selecting a suitable attachment for at least partially covering a bone defect site according to the preamble of claim 19.

[0004] Attachments for covering bone defects have long been state-of-the-art. They are used, in particular, in maxillofacial surgery for bone reconstruction. A bone cavity, created, for example, by a damaging event such as an accident or bone disease, or a surgical procedure, is refilled with bone mass and then the filling site is covered with a membrane to prevent contamination or the migration of soft tissue into it. For example, EP 1 080 700 A2 describes a film made of resorbable polymer material for covering a bone defect, particularly in the form of a bone cavity.The disadvantage of this film is that the initially flat film is placed over an already filled area. The inserted bone augmentation material supports it, and the film can then be molded to the bone. As a result, the film can only be inserted once the filling is complete, preventing the film from adapting to the desired shape. Furthermore, various solutions exist with stiffening elements that stabilize an otherwise flexible film and shape it, as disclosed, for example, in EP 2 062 548 A2. A separate cover is also frequently used, which is combined with a film and supports it.

[0005] The invention is therefore based on the object of providing an attachment which overcomes the disadvantages of the prior art, a method for producing an attachment which overcomes the disadvantages of the prior art, and a method for selecting a suitable attachment for at least partially covering a bone defect site which overcomes the disadvantages of the prior art.

[0006] The invention and its advantages

[0007] The attachment according to the invention, with the features of claim 1, the method according to the invention for producing an attachment, with the features of claim 10, and the method according to the invention for selecting a suitable attachment for at least partially covering a bone defect site, with the features of claim 19, have the advantage that the attachment, which has an extension in a first direction x, in a direction y orthogonal thereto and a direction z orthogonal to x and y, has a membrane or a membrane having at least one stiffening element, or a membrane having at least one stiffening element, on which at least one stiffening element is arranged, wherein the membrane and / or at least one stiffening element consists at least partially of a material which has a shape memory effect and / or such a large restoring force,to return to its original state after elastic deformation. The use of materials with a shape memory effect and / or such a high restoring force that they can return to their original state after elastic deformation enables easy use of the attachment, as it can be inserted without additional stabilization. Depending on the design of the attachment, it can, for example, have at least one opening, which allows the bone mass to be subsequently inserted under the membrane of the attachment. Bending of the attachment, for example during insertion, can in this sense either be reversed directly by a correspondingly high restoring force or, in the case of materials with a shape memory effect, can be induced later by an external impulse. Materials with a shape memory effect can be shape memory alloys,Shape memory polymers or shape memory ceramics that return to their original shape through a pulse. The applied pulse can be heat, UV radiation, a magnetic, electrical, or electromagnetic pulse, or something similar that induces a phase change. The shape memory effect can be one-way, two-way, or multi-way. The attachment can have an at least partially net-like structure with macroscopic openings, or it can be at least partially macroscopically closed, leaving any pore structure unaffected. Macroscopic in this sense is to be understood as meaning that the openings or closed structures are those that are visible to the naked eye. Pores and the like are explicitly excluded. The macroscopic openings are continuous openings. It would also be conceivable tothat parts of the attachment have macroscopic openings, while the remaining part has no such openings. Furthermore, it is conceivable that, in addition to the basic structure of the membrane, there are openings that serve for the application of fluids, bone substitute materials, autologous bone, mixtures thereof, or other substances, or that function as a drilling template based on the backward planning principle for implants, for example. It is conceivable that the attachment is designed to mimic the shape of the bone to be regenerated, so that after removal or dissolution of the attachment, the regenerated bone corresponds to the undamaged bone.

[0008] A stiffening element can, for example, be a reinforcement of the membrane, achieved by thickening the edge of the membrane or another area. It is conceivable that the attachment has a macroscopic single-layer or multi-layer structure. In the latter case, it would be conceivable for an entire layer to function as a stiffening element, or for at least one stiffening element to be arranged between two layers, which could then accordingly represent walls. It would also be conceivable for a cavity to be arranged between two layers, into which a stiffening element can be inserted. This would then have the advantage that only the stiffening element would have to be adapted to the three-dimensional shape of a bone defect.

[0009] It is possible to attach parts to the attachment according to the invention that may or may not be dimensionally stable, for example positioning means for better positioning. Due to an optimal passive fit of the attachment according to the invention, which is supported, for example, by at least one positioning means, it is possible to dispense with fixation means (e.g. pin, screw, adhesive, or the like) that fasten the attachment according to the invention to the bone. Of course, a positioning means is an optional element that, depending on the nature of the bone defect, can have a positive effect on the positioning of the attachment. Nevertheless, the positioning means(s) can also be omitted for other bone defect locations. In this sense, it would also be possible to attach a positioning means to the membrane with a predetermined breaking point in order to separate it from the membrane as needed.

[0010] The attachment according to the invention is stiffened either by itself or by at least one stiffening element in such a way that, by keeping the space to the bone defect site clear, it allows controlled bone regeneration within this cleared space. The at least one stiffening element makes it possible to make the remaining wall thickness of the attachment according to the invention thinner, thereby saving material. Whether with or without at least one stiffening element, the attachment according to the invention has the rigidity required to allow undisturbed bone regeneration to occur in the 3D space protected by the attachment according to the invention. The attachment according to the invention thus forms a particularly dimensionally stable container.

[0011] It is conceivable that the attachment according to the invention, a positioning means, and / or a fixing means can be made of different materials. According to an advantageous embodiment of the attachment according to the invention, at least one stiffening element is detachably arranged on the membrane.

[0012] According to an additional advantageous embodiment of the attachment according to the invention, the attachment is at least partially made of a resorbable material. This has the advantage that, at the latest after the completion of the healing process, the attachment can be largely easily broken down by the body, thus avoiding a further procedure to remove the attachment. In this regard, it would be conceivable for non-resorbable parts of the attachment to be used, for example, to position the attachment and for these parts to be removed before the completion of the attachment installation process, preferably through easily separated predetermined breaking points. It would also be conceivable for the attachment to be made entirely of a resorbable material.

[0013] According to an advantageous embodiment of the attachment according to the invention, the resorbable material is a polymer. It would be particularly conceivable for the polymer to be a thermoplastic or thermoset. It would also be conceivable for the resorbable material to be a composite composed of a polymer and a mineral, preferably bone or bone substitutes, whereby the latter can remain in the body without being degraded.

[0014] According to an advantageous embodiment of the attachment according to the invention, the absorbable material is polycaprolactone.

[0015] According to an additional advantageous embodiment of the attachment according to the invention, the membrane has at least one predetermined breaking point in the x, y and / or z direction, wherein cutting the predetermined breaking point reduces the expansion of the attachment in at least one direction. This has the advantage that, in the case of membranes that are not individually manufactured, the size or expansion of the membrane can be adjusted. It would be conceivable for at least one of the predetermined breaking points to be manufactured in such a way that it can be destroyed, for example, by simply cutting through with a scalpel, scissors, a saw or by means of an angle grinder. It would also be conceivable for the predetermined breaking point to have a further perforation that can be easily bent open, thereby breaking the predetermined breaking point.

[0016] According to an additional advantageous embodiment of the attachment according to the invention, the attachment has at least one fixing element and / or at least one positioning means. A fixing means makes it possible to fix the attachment at the site of use, so that, for example, when treating a bone defect, slipping of the attachment after positioning can be prevented. The fixing means can be reversibly attached to the attachment, for example by one or more predetermined breaking points, or firmly attached to the same and likewise made of a resorbable material. It is conceivable that the rate at which the material is resorbed is identical to the rate at which the attachment as a whole is resorbed, or different from it. A positioning means allows the attachment to be positioned more precisely.A positioning means can, for example, be a support surface that rests on an adjacent object or an adjacent bone area in order to achieve more precise positioning of the attachment.

[0017] According to an additional advantageous embodiment of the attachment according to the invention, the attachment has at least one opening for securing an implant in the bone. The opening can also simultaneously function as a drilling template.

[0018] According to an additional advantageous embodiment of the attachment according to the invention, the attachment comprises an upper side and an opposite lower side, wherein the lower side at least partially comprises a gyroid structure. It would be conceivable for the gyroid structure to be embedded as a cophase in a crystalline or amorphous structure.

[0019] Gyroid structures exhibit infinitely connected triply periodic minimal surfaces. Initial studies have shown that their use can prevent cell penetration, which may be beneficial for bone regeneration (M. Jaber et al., Front. Bioeng. Biotechnol. 2022 10: 995266). Another advantage of such gyroid structures is that they have a lower density than comparable bulk structures with comparable strength.

[0020] The method according to the invention for producing an attachment, wherein the attachment is intended for at least partially covering a bone defect site of a bone region of a living being of a species, preferably of the human species, has the advantage over the prior art that from a bone base data set, which is a base data set of a healthy bone region comparable to the bone region to be treated or of a bone region comprising the entire bone region to be treated of the living being having the bone defect site or of a living being belonging to the same species, a bone average data set corresponding to the bone base data set is generated, or an already existing and thus generated bone average data set is selected, or that from at least two bone base data sets,the base data sets are of a healthy bone area comparable to the bone area to be treated or of a bone area comprising a bone defect, or of a bone of a living being belonging to the same genus or living beings belonging to the same genus comprising the entire bone area to be treated, a bone average data set is generated or an already existing and thus generated bone average data set is selected, and / or that from an essay base data set, which is a base data set of an essay already created for a bone area comparable to the bone area to be treated, an essay average data set corresponding to the essay base data set is generated or an already existing and thus generated essay average data set is selected, or that from at least two essay base data sets,the base data sets are from attachments already produced for bone areas comparable to the bone area to be treated, an attachment average data set is generated or an already existing and thus generated attachment average data set is selected in order to model a model of an attachment for the bone area to be treated according to the generated or selected bone average data set and / or the generated or selected attachment average data set or to select an already existing model for the bone area to be treated in order to then produce the attachment (1) according to the modeled or selected model of an attachment using a manufacturing process.

[0021] For each jaw segment, there is therefore a shape or an average shape of an attachment according to the invention, which can be selected because this shape fits with a high degree of certainty. This allows the user to select a suitable attachment from the range without having to resort to custom production, which enables faster readiness for use. The image underlying a basic bone dataset can either have been taken of a healthy bone or bone area, or of a damaged one. In both cases, different advantages arise: on the one hand, the target condition is better represented in the case of a healthy bone, and on the other hand, the extent of an average damage pattern is taken into account in the case of a bone defect, which can be relevant for the size and extent of the attachment.The combination of healthy bones and bones with a bone defect can also be realized in the average dataset in such a way that a common profile is created in which both states overlap, resulting in a bone in the average bone dataset that contains both the ideal healthy state and the damaged state, with both 3D images superimposed. The latter allows for the best possible adaptation of the attachment. The base datasets (bone base dataset, attachment base dataset) can also contain metadata such as gender, age, damage event, position, and the like, which allow for filtering and more precise classification of the base datasets. The application of the invention is not limited to humans, but can also be used, for example, in animals of a certain species.According to an advantageous embodiment of the method according to the invention for producing an attachment, the manufacturing method is a computer-aided manufacturing method or an alternatively suitable method (e.g. injection molding method) which is possible for producing an attachment.

[0022] According to an additional advantageous embodiment of the method according to the invention for producing an attachment, the bone base data set(s) represent the bone region in its three-dimensionality with or without a bone defect and / or the attachment base data set represents the already produced attachment in its three-dimensionality, or the attachment base data sets represent the already produced attachments in their three-dimensionality, which has the advantage that a more adequate adaptation of the attachment model is possible with three-dimensional data. Unlike, for example, two-dimensional data (width, height, length, and the like), three-dimensional data, especially with a high data point density, allow the complete representation of an object, in this case a jawbone region, which allows for an exact adaptation of the attachment to this jawbone region.In this sense, it would also be possible, for example, in the case of superimposed data sets containing healthy and damaged bones, to generate an optimized attachment by, for example, appropriately incorporating predetermined breaking points, which is preferably intended for different, in particular the most common or most probable, damage patterns and, for example, has different removable positioning devices.

[0023] According to an additional advantageous embodiment of the method according to the invention for producing an attachment, the bone average data set represents the entire bone or only a bone region in its three-dimensionality, or the attachment average data set represents an attachment in its three-dimensionality. Ideally, to create a bone base data set, the bone having the bone defect site is virtually brought into the shape desired after bone regeneration in order to subsequently arrange the attachment according to the invention thereon.According to an additional advantageous embodiment of the method according to the invention for producing an attachment, an attachment is adapted for at least one bone region of a bone based on the bone average data set, wherein the adaptation to a computer-generated 3D model of the bone region or of the entire bone is carried out directly on this model and the thus generated model of an attachment is stored in a planning data set.

[0024] According to an advantageous embodiment of the method according to the invention for producing an attachment, the planning data set is stored in such a way that it can be expanded and / or refined with new bone base data sets and / or updated planning data sets. This allows an existing data set to be updated and refined using a larger database. It would also be conceivable to generate different bone average data sets for specific damage patterns or bone defects or diseases, so that a specific bone average data set is used depending on the case. This can also be achieved by hierarchically structuring the combined bone base data sets, in which certain bone base data sets are hidden for a specific case and the bone average data set is recalculated as required.

[0025] According to an additional advantageous embodiment of the method according to the invention for producing an attachment, the bone average data set and / or the attachment average data set are stored in such a way that the bone average data set can be expanded and / or refined by new bone base data sets and / or the attachment average data set can be expanded and / or refined by new attachment base data sets.

[0026] With regard to both the bone datasets and the essay datasets, it is conceivable that an algorithm supported by artificial intelligence (AI), particularly from the field of statistical learning (machine learning), could be used to generate additional datasets. This would have the advantage, among other things, of generating bone defects with a lower prevalence, particularly depending on the metadata, in order to broaden the dataset. This would mean, for example, that if little data on bone defects in female children is available, the AI ​​would generate pseudo-datasets representing a female child from the data of adult females, particularly the differences compared to adult males, and the data of male children, particularly the differences compared to adult males.

[0027] According to an additional advantageous embodiment of the method according to the invention for producing an attachment, several bone base data sets, each with a different size of the respective bone or bone region, are classified into different size categories based on the size of the respective bone region, and at least one average bone data set is generated for each size category based on these size categories, or several attachment base data sets, each with a different size of an attachment for a bone region to be treated, are classified into different size categories based on the size of the attachment, and at least one average attachment data set is generated for each size category based on these size categories. This allows the production of an assortment of attachments with different sizes (e.g., clothing sizes S, M, L, XL, etc.).), for different damage profiles, genders, age groups, bone areas and the like, which can be selected and used directly or produced as required.

[0028] According to an additional advantageous embodiment of the method according to the invention for producing an attachment, the attachment is an attachment according to one of claims 1 to 8.

[0029] The method according to the invention for selecting a suitable attachment for at least partially covering a bone defect has the advantage over the prior art that the bone defect of a bone or bone region is identified and / or measured and then, based on the determined size of the bone or bone region, an attachment that is at least approximately the same size is selected from a range that includes attachments for this bone or bone region in different sizes and / or the attachment is adapted to a three-dimensional computer model of the bone defect and an attachment that is at least approximately the same size is selected. This allows a surgeon who has several attachments in stock to select the appropriate one and insert it directly. Alternatively, they can also manufacture or order the selected attachment directly or have it manufactured or ordered.

[0030] According to an advantageous embodiment of the method according to the invention for selecting a suitable attachment, software is used to select the attachment that is at least approximately the right size. It would also be conceivable to use a K1-supported system that selects and suggests the most suitable attachment based on a recorded bone defect site, preferably as a three-dimensional model, which could also be measured or evaluated mechanically. A system that performs an image comparison with existing attachments using a brute-force method would also be conceivable.

[0031] According to an additional advantageous embodiment of the method according to the invention for selecting a suitable attachment, the attachment was manufactured using a method in which

[0032] - a bone average data set is generated from at least two bone base data sets, which are base data sets of a healthy bone area comparable to the bone area to be treated or of a bone area comprising the entire bone area to be treated of a living being belonging to the same genus or of living beings belonging to the same genus, or an already existing bone average data set generated in this way is selected and / or

[0033] - an average attachment data set is generated from at least two attachment base data sets, which are base data sets of attachments already produced for bone areas comparable to the bone area to be treated, or an already existing and thus generated attachment average data set is selected in order to model a model of an attachment for the bone area to be treated according to the generated or selected bone average data set and / or the generated or selected attachment average data set, or to select an already existing model for the bone area to be treated in order to then produce the attachment using a manufacturing process according to the modeled or selected model of an attachment,

[0034] - wherein several bone base data sets, which have a different size of the respective bone or bone area, are classified into different size categories based on the size of the respective bone area, and based on these size categories, at least one bone average data set is generated for each size category and the size of the bone or bone area corresponds to the size category of the selected attachment

[0035] - or

[0036] - wherein a plurality of attachment base data sets, which have a different size from attachments already produced for bone areas comparable to the bone area to be treated, are classified into different size categories based on the size of the respective attachment, and based on these size categories, at least one attachment average data set is generated for each size category and the size of the attachment corresponds to the size category of the selected attachment.

[0037] In addition to the size category, other factors, such as different bone defects (e.g., bone atrophies, anomalies caused by bone diseases), gender, age groups, bone regions, and the like, can also be used for classification, and the selection can also be made based on these factors in addition to or instead of these. According to an advantageous embodiment of the method according to the invention for selecting a suitable attachment, the attachment is an attachment according to one of claims 1 to 8, and / or the attachment is manufactured according to a method for manufacturing an attachment according to one of claims 9 to 15.

[0038] Further advantages and advantageous embodiments of the invention can be found in the following description, the claims and the drawings.

[0039] Drawings

[0040] Preferred embodiments of the subject matter according to the invention are illustrated in the drawings and are explained in more detail below.

[0041] Fig. 1 is a schematic representation of an attachment according to the invention,

[0042] Fig. 2 is a schematic representation of another embodiment of an attachment according to the invention,

[0043] Fig. 3 is a schematic representation of another embodiment of an attachment according to the invention,

[0044] Fig. 4 of a further embodiment of an attachment according to the invention,

[0045] Fig. 5 is a schematic representation of another embodiment of an attachment according to the invention,

[0046] Fig. 6 is a schematic representation of a further embodiment of an attachment according to the invention, Fig. 7 is a schematic representation of a further embodiment of an attachment according to the invention,

[0047] Fig. 8 is a schematic representation of another embodiment of an attachment according to the invention,

[0048] Fig. 9 is a schematic representation of another embodiment of an attachment according to the invention,

[0049] Fig. 10 is a schematic representation of another embodiment of an attachment according to the invention,

[0050] Fig. 11 is a schematic representation of another embodiment of an attachment according to the invention,

[0051] Fig. 12 is a schematic representation of another embodiment of an attachment according to the invention,

[0052] Fig. 13 is a schematic representation of another embodiment of an attachment according to the invention,

[0053] Fig. 14 is a schematic representation of another embodiment of an attachment according to the invention,

[0054] Fig. 15 is a schematic representation of another embodiment of an attachment according to the invention with a gyroid structure on the underside,

[0055] Fig. 16 is a schematic representation of a further embodiment of an attachment according to the invention with a cover placed thereon, Fig. 17 is a schematic representation of a further embodiment of an attachment according to the invention with a cover attached to a simple hinge,

[0056] Fig. 18 is a schematic representation of a further embodiment of an attachment according to the invention with a lid attached to film hinges and

[0057] Fig. 19 is a schematic representation of another embodiment of an attachment according to the invention with a lid attached to film hinges and a wide gap.

[0058] Description of the embodiments

[0059] Fig. 1 shows a schematic representation of an attachment 1 according to the invention. The attachment 1 according to the invention has a membrane 2 and stiffening elements 3. In addition, the membrane 2 according to the invention has regions with a net-like structure 4, which has macroscopic openings 5, and a region with a closed structure 6. The membrane 2 is preferably made of a resorbable material and the stiffening elements 3 are preferably irreversibly connected to the membrane 2. The stiffening elements 3 have such a high restoring force that after the attachment 1 is bent, it springs back to its original shape. Furthermore, openings 7 for fixation means (not shown) are arranged on the membrane 2. The size of the attachment 1 or another specification can preferably be indicated on a type plate 7 8. The attachment 1 shown is macroscopically manufactured in a single layer and also has positioning means 9.In the illustrated embodiment, the attachment 1 can be placed over the bone area to be treated. The concave side or wall of the attachment faces the bone or bone defect, and the convex side or wall faces away from the bone or bone defect. In this sense, all of the exemplary embodiments presented below also have a side facing and a side facing away from the bone or bone defect.

[0060] Fig. 2 and Fig. 3 show schematic representations of further embodiments of an attachment 1 according to the invention, in which different areas with net-like structures 4 with macroscopic openings 5 ​​are depicted.

[0061] Fig. 4 shows a schematic representation of another embodiment of an attachment 1 according to the invention. In this embodiment, the membrane 2 according to the invention has regions with a mesh-like structure 4 with macroscopic openings 5 ​​of a first type and regions with a mesh-like structure 4' with macroscopic openings 5' of a second type. Positioning means 9 are also shown.

[0062] Fig. 5 shows a schematic representation of a further embodiment of an attachment 1 according to the invention, according to Fig. 4, without positioning means 9. The positioning means is preferably attached to the attachment in such a way that it can be correctly positioned. In principle, all attachments in all embodiments shown are attachments according to the invention, even without positioning means attached thereto.

[0063] Fig. 6 shows a schematic representation of another embodiment of an attachment 1 according to the invention. In this embodiment, the stiffening element 3 is arranged on the edge 10 of the attachment 1 according to the invention. Furthermore, the attachment 1 according to the invention, which can be fixed to a bone (not shown) by means of fixing means 11, which are designed as pins, for example, has regions with a closed structure 6. In addition, predetermined breaking points 12 serve to disassemble the attachment 1 according to the invention into at least two parts if necessary. The fixing means 11 can be attached to the attachment with predetermined breaking points, which are released, for example, when the fixing means are screwed in.

[0064] Fig. 7 shows a schematic representation of another embodiment of an attachment 1 according to the invention. In this embodiment, a stiffening element 3 is arranged on the edge 10. Furthermore, further stiffening elements 3 are arranged on the sides 13 and the top 14 of the attachment 1 according to the invention, which are connected to one another by means of predetermined breaking points 12. It is also conceivable that predetermined breaking points 12 are also arranged on the edge 10.

[0065] Fig. 8 shows a schematic representation of another embodiment of an attachment 1 according to the invention. In this embodiment, the stiffening element 3 is arranged on the edge 10 of the attachment according to the invention, which has a region with a closed structure 6.

[0066] Fig. 9 shows a schematic representation of a further embodiment of an attachment 1 according to the invention. In contrast to the embodiment shown in Fig. 7, the attachment 1 according to the invention in this embodiment has openings 7 in order to be able to fasten the attachment 1 according to the invention to the bone by means of fixing means 11 after the stable positioning of the attachment 1 according to the invention with the aid of the positioning means 9.

[0067] Fig. 10 shows a schematic representation of a further embodiment of an attachment 1 according to the invention. In contrast to the embodiment shown in Fig. 8, the attachment 1 according to the invention in this embodiment has transverse stiffening elements 3.

[0068] Fig. 11 shows a schematic representation of a further embodiment of an attachment 1 according to the invention. In this embodiment, openings 15 are arranged on the upper side 14 of the attachment 1 according to the invention. These openings 15 serve for simple treatment of the bone defect after the attachment 1 according to the invention has been placed on the bone and / or for the application of fluids, bone substitute materials, autologous bone, mixtures thereof or other substances and / or function as a drilling template based on the backward planning principle for, for example, implants. It is conceivable that at least one opening 15 is closed by at least one cover (not shown) after treatment. It would also be conceivable for the cover to be attached to the membrane, for example by fastening means such as pins, hook-and-eye connections or directly by irreversible joining methods such as ultrasonic welding.It would also be conceivable if the cover is arranged on the attachment by means of a hinge, so that the attachment 1 can be opened to allow easy treatment of the bone defect and / or filling of material.

[0069] 12 to 14 show schematic representations of further embodiments of an attachment 1 according to the invention. In these embodiments, openings 16 are arranged on the upper side 14, which serve for the simple treatment of the bone defect after the attachment 1 according to the invention has been placed on the bone and / or for the application of fluids, bone replacement materials, autologous bone, mixtures thereof or other substances and / or which function in the sense of a drilling template based on the backward planning principle for implants, for example, and / or through which an implant can be fastened in the bone.

[0070] Fig. 15 shows a schematic representation of another embodiment of an attachment 1 according to the invention with a gyroid structure 17 on the underside of the attachment 1. This structure can, of course, also be implemented in all other embodiments, with attachments 1 in which at least part of the wall is closed being particularly suitable.

[0071] Fig. 16 shows a schematic representation of a further embodiment of an attachment 1 according to the invention with a lid 18 placed on top. The lid 18 can initially be omitted during the positioning of the attachment 1 and can be placed back on after the inner region of the attachment 1 has been filled. The lid 18 is preferably manufactured to fit precisely and the edge of the lid opening is designed in such a way that the lid 18 is prevented from falling through. For this purpose, for example, the edge and the lid 18 can be bevelled in opposite directions over the entire width or only over parts of the edge of the opening in order to achieve a positive connection. Other forms of positive connection are also conceivable in principle. The placed lid 18 is particularly suitable for applications with reduced free space above the attachment 1. The lid 18 orThe opening provided for this does not necessarily have to be centrally located on the attachment 1, but can also be offset in all directions.

[0072] Fig. 17 shows a schematic representation of a further embodiment of an attachment 1 according to the invention with a lid 18 fastened to a simple hinge 19. The hinge 19 allows the lid 18 to be folded away or removed in a simple manner during the introduction of bone (replacement) mass.

[0073] Fig. 18 shows a schematic representation of a further embodiment of an attachment 1 according to the invention with a lid 18 fastened to film hinges 20. By using two or more hinges (19, 20), a greater rigidity of the lid 18 can be achieved, which means that even a lid 18 that does not fit perfectly and leaves a gap 21 between the lid border and the further attachment 1 can be used. Film hinges 20 also have the advantage that they enable a one-piece production of the attachment. The film hinge can also be designed such that the connection point between the lid and the rest of the attachment is designed as a predetermined breaking point, which can be easily severed as needed.

[0074] Fig. 19 shows a schematic representation of another embodiment of an attachment 1 according to the invention with a lid 18 attached to film hinges 20 and a wide gap 21. The wide gap 21 has the advantage that the lid 18 can be opened more easily, for example, by levering it open with a scalpel.

[0075] Within the scope of one embodiment of the method according to the invention for manufacturing an attachment 1, an average bone data set of a mandibular bone is generated by averaging several bone base data sets of mandibular bones from adult humans. In this case, the bone base data sets are computed tomography images of the jaw area of ​​several people, representing the jawbone in its three-dimensionality. The bone cross-sectional data set also represents a mandibular bone in its three-dimensionality. Based on the generated average bone data set, the jawbone is divided into different bone regions, and an attachment 1 is virtually adapted and subsequently manufactured for each of these regions.Thus, attachments 1 are available for different bone areas, which are selected by a surgeon according to the method according to the invention by identifying and measuring the bone defect to be treated and, based on the results, selecting an approximately suitable attachment 1. Predetermined breaking points 12 can be provided on the attachment 1 in the x, y, and z directions, which allow the attachment 1 to be shortened if the surgeon determines that the selected attachment 1 is too large. Preferably, several predetermined breaking points 12 are provided, allowing for more detailed adjustment.

[0076] In another embodiment, pre-generated data sets of attachments for specific bone regions are selected, or existing attachments are measured. Based on these base attachment data sets, an average attachment data set is created by (weighted) averaging, and a virtual average attachment is manufactured based on the thus generated virtual average attachment.

[0077] All features presented here can be essential to the invention both individually and in any combination.

[0078] Reference number list

[0079] 1 essay

[0080] 2 membrane

[0081] 3 stiffening element

[0082] 4 Area with net-like structure

[0083] 4' area with net-like structure

[0084] 5 Macroscopic opening

[0085] 5' Macroscopic opening

[0086] 6 Area with closed structure

[0087] 7 Opening for fixative

[0088] 8 Type plate

[0089] 9 Positioning devices

[0090] 10 Rand

[0091] 11 Fixatives

[0092] 12 Predetermined breaking point

[0093] 13 Page

[0094] 14 Top

[0095] 15 Opening

[0096] 16 Opening

[0097] 17 Gyroid structure

[0098] 18 lids

[0099] 19 Hinge

[0100] 20 film hinge

[0101] 21 gap

Claims

Patent claims 1 . Attachment (1) for at least partially covering a bone defect site, wherein the attachment (1) has an extension in a first direction x, in a direction y orthogonal thereto and a direction z orthogonal to x and y, characterized in that the attachment (1) has a membrane (2) or a membrane (2) having at least one stiffening element (3) or a membrane (2) having at least one stiffening element (3) on which at least one stiffening element (3) is arranged, wherein the membrane (2) and / or at least one stiffening element (3) consists at least partially of a material which has a shape memory effect and / or such a large restoring force that it returns to its original state after an elastic deformation.

2. Attachment (1) according to claim 1, characterized in that at least one stiffening element (3) is detachably arranged on the membrane (2).

3. Attachment (1) according to claim 1 or claim 2, characterized in that the membrane (2) is at least partially made of a resorbable material.

4. Attachment (1 ) according to claim 3, characterized in that the absorbable material is a polymer.

5. Attachment (1 ) according to claim 4, characterized in that the absorbable material is polycaprolactone.

6. Attachment (1) according to one of the preceding claims, characterized in that the membrane (2) has at least one predetermined breaking point (12) in the x-, y- and / or z-direction, wherein a separation of the predetermined breaking point (12) reduces the expansion of the attachment (1) in at least one direction.

7. Attachment (1) according to one of the preceding claims, characterized in that the attachment (1) has at least one fixing element (11) and / or at least one positioning means (9).

8. Attachment (1) according to one of the preceding claims, characterized in that the attachment (1) has at least one opening (16) in order to be able to fix an implant in the bone.

9. Attachment (1) according to one of the preceding claims, characterized in that the attachment (1) comprises an upper side (14) and an opposite lower side, wherein the lower side at least partially has a gyroid structure.

10. A method for producing an attachment (1), wherein the attachment (1) is intended for at least partially covering a bone defect site of a bone region of a living being of a species, preferably of the human species, characterized in that - that from a bone base data set, which is a base data set of a healthy bone area comparable to the bone area to be treated or a bone area containing a bone defect, or of an entire bone area to be treated comprising the bone of the living being containing the bone defect or of a living being of the same species belonging to a living being, a bone average data set corresponding to the bone base data set is generated or an existing bone average data set generated in this way is selected, or - that a bone average data set is generated from at least two bone base data sets, which are base data sets of a healthy bone area comparable to the bone area to be treated or of a bone comprising the entire bone area to be treated of a living being belonging to the same genus or of living beings belonging to the same genus, or that an already existing and thus generated bone average data set is selected, and / or - that an average attachment data set corresponding to the basic attachment data set is generated from an attachment base data set, which is a base data set of an attachment already created for a bone area comparable to the bone area to be treated, or that an already existing average attachment data set created in this way is selected, or - that an average attachment data set is generated from at least two attachment base data sets, which are base data sets of attachments already produced for bone areas comparable to the bone area to be treated, or an already existing and thus generated attachment average data set is selected in order to model a model of an attachment for the bone area to be treated according to the generated or selected bone average data set and / or the generated or selected average attachment data set, or to select an already existing model for the bone area to be treated in order to then produce the attachment (1) using a manufacturing process according to the modeled or selected model of an attachment.

11. Method according to claim 10, characterized in that the manufacturing method is a computer-aided manufacturing method or an alternatively suitable method which is possible for the production of an attachment (1).

12. Method according to claim 10 or claim 11, characterized in that the bone base data set or the bone base data sets represent the bone area in its three-dimensionality with or without a bone defect site and / or the attachment base data set represents the already produced attachment in its three-dimensionality or the attachment base data sets represent the already produced attachments in their three-dimensionality.

13. Method according to one of claims 10 to 12, characterized in that the bone average data set represents the entire bone or only a bone region in its three-dimensionality or the attachment average data set represents an attachment in its three-dimensionality.

14. Method according to one of claims 10 to 13, characterized in that an attachment (1) is adapted for at least one bone region of a bone on the basis of the bone average data set, wherein the adaptation to a computer-generated 3D model of the bone region or of the entire bone is carried out directly on this model and the model of an attachment (1) thus generated is stored in a planning data set.

15. Method according to claim 14, characterized in that that the planning data set is stored in such a way that it can be expanded and / or refined with new bone base data sets and / or updated planning data sets.

16. Method according to one of claims 10 to 15, characterized in that the bone average data set and / or the attachment average data set are stored in such a way that the bone average data set can be expanded and / or refined by new bone base data sets and / or the attachment average data set can be expanded and / or refined by new attachment base data sets.

17. Method according to one of claims 10 to 16, characterized in that a plurality of bone base data sets, which have a different size of the respective bone or bone region, are classified into different size categories based on the size of the respective bone region and, based on these size categories, at least one bone average data set is generated for each size category or a plurality of attachment base data sets, which have a different size of an attachment for a bone region to be treated, are classified into different size categories based on the size of the attachment and, based on these size categories, at least one attachment average data set is generated for each size category.

18. Method according to one of claims 10 to 17, characterized in that the attachment (1) is an attachment (1) according to one of claims 1 to 9.

19. Method for selecting a suitable attachment (1) for at least partially covering a bone defect site, characterized in that that the bone defect site of a bone or a bone region is identified and / or measured and then, based on the determined size of the bone or the bone region, an attachment (1) which is at least approximately the same size is selected from a range which contains attachments for this bone or this bone region in different sizes and / or the attachment is adapted to a three-dimensional computer model of the bone defect site and an attachment (1) which is at least approximately the same size is selected.

20. Method according to claim 19, characterized in that software is used to select the attachment (1) which has at least approximately the size.

21. A method for selection according to claim 19 or claim 20, characterized in that the attachment (1 ) was manufactured by a method in which - a bone average data set is generated from at least two bone base data sets, which are base data sets of a healthy bone area comparable to the bone area to be treated or of a bone area comprising the entire bone area to be treated of a living being belonging to the same genus or of living beings belonging to the same genus, or an already existing and thus generated bone average data set is selected and / or - an average attachment data set is generated from at least two attachment base data sets, which are base data sets of attachments already produced for bone areas comparable to the bone area to be treated, or an already existing average attachment data set generated in this way is selected, to model a model of an attachment for the bone area to be treated according to the generated or selected bone average data set and / or the generated or selected attachment average data set or to select a model already available for the bone area to be treated, in order to then produce the attachment (1) according to the modeled or selected model of an attachment using a manufacturing process, - wherein several bone base data sets, which have a different size of the respective bone or bone area, are classified into different size categories based on the size of the respective bone area, and based on these size categories, at least one bone average data set is generated for each size category and the size of the bone or bone area corresponds to the size category of the selected attachment (1 ) - or - wherein a plurality of attachment base data sets, which have a different size from attachments already produced for bone areas comparable to the bone area to be treated, are classified into different size categories based on the size of the respective attachment, and based on these size categories, at least one attachment average data set is generated for each size category and the size of the attachment corresponds to the size category of the selected attachment (1).

22. Method according to one of claims 19 to 21, characterized in that the attachment (1) is an attachment (1) according to one of claims 1 to 9, and / or the attachment (1) is manufactured according to a method for manufacturing an attachment (1) according to one of claims 10 to 18.

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