WO2016180397A1

WO2016180397A1 - Device for covering and/or reconstructing a bone defect site, method for producing a cap for a cover for a bone defect site

Info

Publication number: WO2016180397A1
Application number: PCT/DE2016/000207
Authority: WO
Inventors: Marcus Seiler
Original assignee: Reoss Gmbh
Priority date: 2015-05-08
Filing date: 2016-05-09
Publication date: 2016-11-17
Also published as: DE102015006154A1

Abstract

The invention relates to a device (1) for covering and/or reconstructing a bone defect site (2) and to a method for producing a cap (4) for a covering device for a bone defect site (2). The device (1) for covering and/or reconstructing a bone defect site (2) consists of a cap (4) (molded shell, rigid shell, molded body) having a rim (16) and of at least one fixing means (5) for fixing the cap (4) on a bone, and the cap (4) is characterized by having a dimensionally stable (rigid) nature. A wall (9) of the cap (4) facing the bone defect or a wall (11) of the cap (4) facing away from the bone defect corresponds to the shape of the regenerated bone, at least one positioning means (13) being located on the rim (16) of the cap (4).

Description

DEVICE FOR COVERING AND / OR RECONSTRUCTING A BONE DEFECTURE TELEPHONE; METHOD FOR PRODUCING A COVER OF A COVER FOR A BONE DEFECT

State of the art

The invention is based on a device for covering and / or reconstruction of a bone defect site, according to the preamble of claim 1, and a method for producing an attachment of a covering device for a bone defect, according to the preamble of claim 20.

Bone defects in the form of recesses or cavities in the body's own bone tissue are often filled with bone augmentation material in bone surgery, for example in the reconstruction of bones in orthopedic, neurosurgical or plastic surgery or in jaw surgery. As a rule, the bone regeneration material consists of a mixture of synthetic bone substitute material (eg hydroxylapatite granules) and the body's own bone particles. In order for the bone regeneration material to grow through substantially exclusively from the bone side, the recess is closed with a cover membrane, as described in the patent specification DE 43 02 708 C2. The covering membrane is attached to the body's own healthy bone adjacent to the bone defect site, which is damaged by the attachment nails, and since the covering membrane is made of a flexible material, the attachment requires the surgeon's skilled craftsmanship. In order to overcome this disadvantage of a lack of support function of the covering membrane, a covering membrane is described in the patent US 48 16 339, which consists of several layers, these layers do not consist of resorbable membrane material. It may be necessary that after healing of the bone defect, a second intervention is necessary to remove foreign material.

In the patent DE 10 2005 039 382 B4, a biodegradable hollow body, which in particular has a hollow cylindrical or conical-cylindrical shape, is proposed. The hollow body has in its walls on a plurality of openings through which a recording of blood and thus the construction of self-bone is possible. The disadvantage here is that for insertion of the hollow body a cylindrical bore must be introduced by means of a drill in the existing bone.

In the published patent application DE 10 2006 047 054 A1, an implant bearing is proposed, which is characterized by high accuracy of fit and stability, so that the attending physician can easily handle and implant it. The implant bearing made of hydroxyapatite, which has a thin membrane, in particular consisting of resorbable material, for protection of the mucous membrane against mechanical influences and for protecting the implant bed against ingrowing tissue from the side of the mucous membrane on the side facing the mucous membrane, is produced using an anabolic manufacturing process so that the material composition forms a "gradient structure" in the sense of a particularly inwardly decreasing density, whereby on the side facing the bone there is a construction with a particularly porous structure and on the outside of the implant bed, on which there is a structure for holding a dental implant and / or a dental prosthesis, provided a compact design. Furthermore, the published patent applications DE 198 30 992 A1, DE 10 2005 060 761 A1, DE 42 26 465 A1, WO 01/91818 A1, DE 10 2005 041 412 A1, DE 10 2006 047 054 A1, US 2011/0151400 A1 WO 00/59409 A1 and WO 2006/051401 A2 and the patent US Pat. No. 7,172,422 B1 describe devices for a bone defect site, all of which have the disadvantage that they affect the healthy bone present in addition to the bone defect site.

The invention and its advantages

The device according to the invention for covering and / or reconstruction of a bone defect site, wherein the term "bone defect site" means a site of (diseased, deformed, injured, altered by aging processes, altered by degeneration (eg after tooth extraction, tumor, etc.) and / or in volume changed bone) (eg hip, spine, head, jaw or the like) of a human or an animal, which deviates from the shape and / or volume of a healthy bone, with the features of claim 1, and the inventive method for production an attachment of a covering device for a bone defect, with the features of claim 20, have the advantage that the device for covering and / or reconstruction of a bone defect site from an edge having attachment (eg, shell mold, rigid shell, molded body), the one or multi-layered, and at least one within The fixation means attachable to the bone defect site for fixing the attachment to a bone, wherein at the edge of the attachment, which is characterized by a dimensionally stable (rigid) nature and at least partially (at the edge) in the boundary region between the bone defect site and the adjacent healthy bone with the bone is in contact and the bone defect facing wall (in the sense of a surface or side) of the essay or a bone defect facing away from the wall (im Meaning of a surface or side) of the attachment of the shape of the bone regenerated within the bone defect site, which by its regeneration again has the shape of a healthy bone, corresponds to at least one positioning means being arranged. The at least one positioning means makes it possible to position the attachment on a healthy bone adjacent to the bone defect site, since the positioning means faces a wall facing away from the healthy bone (in the sense of a surface or side) and a healthy bone and at least partially corresponding thereto Wall (in the sense of a surface or side) has. The attachment is exclusively in the area of the bone defect site, which is covered by the essay completely or at least partially, arranged and / or fixed so that it is not adjacent to the bone defect site healthy bones, on the health anyway no regeneration of the bone takes place affects. Instead of only partial coverage of the bone defect site through the attachment, the attachment is thus preferably matched precisely to the bone defect site and preferably ends flush with the healthy bone. As a result, the bone defect site is completely covered by the not projecting beyond the bone defect site essay.

According to an advantageous embodiment of the device according to the invention, the attachment and / or at least one fixing means and / or at least one positioning means consist at least partially of a biocompatible material.

According to an additional advantageous embodiment of the device according to the invention, the material of organic and / or inorganic origin. This may also be an autogenous, syngeneic, allogenic, xenogeneic, synthetic or alloplastic material.

According to an additional advantageous embodiment of the device according to the invention, the attachment and / or at least one fixing means and / or at least one positioning at least partially made of a biodegradable material.

According to an additional advantageous embodiment of the device according to the invention, the attachment and / or at least one fixing means and / or at least one positioning means may consist at least partially of a resorbable material. Advantageously, the absorption time of the rigid shell can be controlled by its absorption gradient and / or the absorption time can also be less than six months, so that the implant can be used in a timely manner. Resorbable metals or alloys, in particular magnesium or magnesium alloys, are preferably used. The 3D models (e.g., the attachment and / or the fixative) are preferably constructed in a laser melting process under vacuum, preferably using a 3D printer.

According to an additional advantageous embodiment of the device according to the invention, the attachment and / or at least one fixing means and / or at least one positioning means consist at least partially of a polymer or a polymeric compound.

According to an additional advantageous embodiment of the device according to the invention, the attachment and / or at least one fixing agent and / or at least one positioning means consist at least partially of polylactide. Polylactides are composed of many chemically bonded lactic acid molecules and belong to the polymers. The advantage of polylactide plastics, which are also called polylactic acids (PLA), is that they are thermoformable plastics and biocompatible.

According to an additional advantageous embodiment of the device according to the invention, the attachment and / or at least one positioning means has a constant or varying wall thickness. According to a related advantageous embodiment of the device according to the invention, the wall thickness should be at least 0.2 mm, preferably 0.5 mm, but at least as much, so that a dimensional stability of the shell mold or a positioning results.

According to an additional advantageous embodiment of the device according to the invention, the fixing means is a pin, a screw, a nail and / or a bone adhesive. In order to preserve the healthy bone, the fixing agent (s) is / are preferably arranged in the region of the bone defect site.

According to an additional advantageous embodiment of the device according to the invention, the attachment has at least one milling (hole for the fixing agent).

According to a related advantageous embodiment of the device according to the invention, the milling corresponds to the fixing.

According to an additional advantageous embodiment of the device according to the invention, the wall facing the bone defect has a surface conditioning.

According to an advantageous embodiment of the device according to the invention, the surface may have a microstructuring, pores, osteoblast attractants, means for promoting bone growth and / or BMP-containing bone substitute.

According to an additional advantageous embodiment of the device according to the invention, the attachment has at least one opening. This means that the attachment does not have to have a closed wall. Through a variety Of openings, the article may at least in places have a network structure, wherein the bone defect facing away wall of the network structure or the bone defect facing wall of the network structure corresponds to the shape of the regenerated bone.

According to an additional advantageous embodiment of the device according to the invention, the attachment has at least one predetermined breaking point. The predetermined breaking point has the advantage that, if the attachment is to be removed after a successful bone regeneration, this removal can be minimally invasive, without "having to disclose everything", because the attachment can be comminuted into at least two parts due to the predetermined breaking point Removal of the attachment (eg after a bone regeneration) is thus very easily possible.Furthermore, the predetermined breaking point can serve to separate unneeded parts of the attachment from the rest of the attachment.

According to an additional advantageous embodiment of the device according to the invention, the attachment has at least one fastening device (for example a recess) for at least one implant to be placed.

According to an advantageous embodiment of the device according to the invention, at least one fastening device (for example a recess) is at least partially covered by a part of the attachment which is connected to the remaining part of the attachment by means of at least one predetermined breaking point.

According to a related advantageous embodiment of the device according to the invention, at least one predetermined breaking point is arranged between the attachment and a positioning means. This allows a positioning, which rests on the healthy bone and thus ggfls. disturbing, for example, after fixation of the essay or after the regeneration of the bone at the bone defect site, be removed from the possibly remaining essay. According to an advantageous embodiment of the method according to the invention for producing an attachment of a covering device for a bone defect site, in which the computer-aided design (CAD) of the article with a computer-aided manufacturing (CAM) is combined to CAD / CAM, so that a developed on the computer design model of the essay directly transmitted electronically to the production, consisting of the following process steps:

- recording a dataset representing the affected bone defect site in its three-dimensionality, using tomography or similar imaging techniques,

Use of the data set for planning the attachment, which has a wall facing away from the bone defect and a wall facing the bone defect, and can be fixed to a bone with at least one fixing means,

- Implement planning of the essay into a planning dataset and

Supply of the planning data record to a computer-controlled manufacturing process,

wherein the attachment is formed of a dimensionally stable material and the wall facing the bone defect (in the sense of a surface or side) or its wall facing away from the bone defect ((in the sense of a surface or side) corresponds to the shape of the regenerated bone, and the recording of the data set, which represents the affected bone defect site in its three-dimensionality by means of tomography, computed tomography, digital volume tomography, sonography or the like, takes place, during and / or after the manufacture of the essay at the edge of the essay at least one positioning means is arranged for positioning the attachment to a healthy bone adjacent to the bone defect site on the attachment and that facing away from the healthy bone (in the sense of a surface or side) and a healthy bone and at least partially corresponding facing wall (in the sense of Surface or page) has, the recording of the first record represents the affected bone defect site in its three-dimensionality and / or the recording of the second data set represents the shape of the still healthy bone in its three-dimensionality.

According to an additional advantageous embodiment of the method according to the invention for producing an attachment of a covering device for a bone defect site, the recording of the first data set, which represents the actual state, and / or the recording of the second data set, which represents the desired state, by at least one Imaging process.

According to an additional advantageous embodiment of the method according to the invention for producing an attachment of a covering device for a bone defect site, the recording of the first data set and / or the recording of the second data set with at least one method which allows a three-dimensional representation of a bone. In particular, the recording of the first data set and / or the recording of the second data set take place by means of tomography, computed tomography, digital volume tomography, sonography or the like.

According to an additional advantageous embodiment of the method according to the invention for producing an attachment of a covering device for a bone defect site, the recording of the record of the healthy bone, after the healthy bone is fully grown. This makes it possible that if necessary. the ideal state (nominal state) of the bone is documented so that it is known how an event. later to look to regenerating bones. In humans, the record of the healthy bone should preferably be taken at the age of 18 to 25 years. Of course, it is also conceivable that recorded in the adult state of the bone several healthy bones or the entire skeleton of the human or animal, documented and / or stored. It would also be conceivable that at the time of admission of healthy bone an essay is at least partially made.

According to a related advantageous embodiment of the method according to the invention for producing an attachment of a covering device for a bone defect site, the record of the healthy bone is stored (preserved) for its later use on a storage medium.

According to an additional advantageous embodiment of the method according to the invention for producing an attachment of a covering device for a bone defect site, the attachment is formed by means of milling in the manufacturing process.

According to an additional advantageous embodiment of the method according to the invention for producing an attachment of a covering device for a bone defect site, at least one fastening device for at least one implant to be placed on the attachment is arranged during the manufacture of the attachment. The fastening device can be configured for example as a recess.

According to a related advantageous embodiment of the method according to the invention for producing an attachment of a covering device for a bone defect site at least one fastening device (eg recess) by removing a portion of the article, which is connected before removal by means of at least one predetermined breaking point with the remaining part of the essay, exposed , The time of exposure of the fastening device can be before or after the arrangement of the covering at the bone defect site.

According to an additional advantageous embodiment of the method according to the invention for producing an attachment of a covering for a Bone defect site is placed during the manufacture of the essay at least one predetermined breaking point on the essay.

According to an additional advantageous embodiment of the method according to the invention for producing an attachment of a covering device for a bone defect site, at least one predetermined breaking point is arranged between the attachment and a positioning means.

According to an additional advantageous embodiment of the method according to the invention for producing an attachment of a covering device for a bone defect site, a cleaning and / or sterilization process is carried out during the manufacture of the attachment.

According to an additional advantageous embodiment of the method according to the invention for producing an attachment of a covering device for a bone defect site, the attachment can be used in a device for covering and / or reconstructing a bone defect site according to claims 1 to 19. Thus, a device for covering and / or reconstruction of a bone defect site can be created, whose attachment and / or fixing, for example, an artificial material and / or a material of autogenous, synergistic, allogeneic or xenogeneic origin human and / or animal bones or the human , animal or artificial matrix has a shape that completely or almost completely fills the area between the bone and the desired shape of the regenerated bone. For this purpose, the dispenser is e.g. taken a bone block, which is then optionally modeled using CAD / CAM.

By means of the method according to the invention, a device according to the invention for covering and / or reconstructing a bone defect site can be created whose attachment and / or fixing means originate, for example, from a material of organic and / or inorganic origin. This can too a synthetic material and / or a material of autogenous, synergistic, allogeneic and / or xenogenic, alloplastic, human and / or animal origin. In this case, the human, animal or synthetic matrix may also have a shape by which the area located between the bone and the desired shape of the regenerated bone is completely or almost completely filled. For this purpose, the donor (intrinsic or foreign donor), for example, a bone block removed, which is then optionally modeled using CAD / CAM.

Further advantages and advantageous embodiments of the invention are the following description, the drawings and claims removed.

drawing

Embodiments of the subject invention are illustrated in the drawing and are explained in more detail below. Show it:

1 shows an illustration of a device according to the invention for covering and / or reconstruction of a bone defect site,

FIG. 2 shows a representation of a differently shaped device according to the invention for covering and / or reconstruction of a bone defect site, FIG.

3 shows a representation of a differently shaped device according to the invention for covering and / or reconstruction of a bone defect site, 4 shows a representation of a differently shaped device according to the invention for covering and / or reconstruction of a bone defect site,

5 shows a detail of an article,

Fig. 6 to 8 different representations of an essay with positioning and

9 shows an attachment arranged at a bone defect site.

Description of the embodiments

1 shows an illustration of a device 1 according to the invention for covering and / or reconstructing a bone defect 2 (bone defect) of a bone, in particular a jawbone 3. The device 1 consists of an attachment 4, which is monolayered, and a fixing means 5, which so as not to injure the healthy bone adjacent to the bone defect site 2, shown as a pin in Fig. 1 in the bone defect site 2. Of course, it is also conceivable that a plurality of fixing means 5 are used for fixing the attachment 4, which would also be arranged in the bone defect site 2. The article 4 is made of a dimensionally stable material, so that it is self-supporting and no additional support is necessary. To fix the attachment 4 (shell mold, rigid shell), the fixing 5 is pushed through a hole 6 in the article 4 and then inserted into the arranged in the jaw bone 3 hole 7. The subsequent fixation of the attachment 4 is preferably carried out by ultrasonic welding. In ultrasonic welding, an ultrasonic generator preferably generates a precisely defined frequency, which is bundled via a sonotrode. After placing the resorbable fixative 5 (pin) on a pre-drilled hole in the bone (Hole 7), a generated vibration causes liquefaction of the pinhole surfaces at its edges, causing the pin to slip into the borehole. By changing the state of aggregation, the pin also penetrates into the bony cavities, which are unreachable by a conventional bone screw, so that a high initial strength is achieved. In addition, the Pinkopf connects with the attachment 4 and provides with a locking mechanism for a stable three-dimensional construct. In ultrasonic welding, the fixative 5 is thus softened, so that it connects to the jawbone 3 and the attachment 4. The fixed attachment 4 creates a sealed interior space 8 between the jawbone 3 and the attachment 4, which is produced by the regeneration of the bone and / or by introducing a material of organic and / or inorganic origin, which is also an autogenous, syngeneic, allogeneic, xenogenic, synthetic and / or alloplastic material, is filled, so that the regenerated bone or the introduced material of the shape of the bone defect site 2 facing wall 9 (in the sense of a surface or side) of the single-layered attachment 4 corresponds. In order to accelerate the regeneration process of the jawbone 3, the wall 9 of the attachment 4 facing the bone defect may have surface conditioning (eg microstructuring, pores, osteoblast decoctions, bone growth promoting agents and / or BMP-containing bone substitute).

2 shows an illustration of a differently shaped device 1 according to the invention for covering and / or reconstructing a bone defect 2 (bone defect) of a bone, in particular a jaw bone 3. In this figure, the gingiva 10 is additionally indicated.

3 shows an illustration of a differently shaped device 1 according to the invention for covering and / or reconstructing a bone defect 2 (bone defect) of a bone, in particular a jaw bone 3. In this figure, the attachment 4 is in the form of a molded body, for example of human or animal origin Bone shaped and has a the bone defect facing wall 9 (in the sense of a surface or side), which is adapted to the relief of the bone defect site 2, and a bone defect facing away from the wall 11 (in the sense of a surface or side), the Form of regenerated bone corresponds to.

4 shows an illustration of a differently shaped device 1 according to the invention for covering and / or reconstructing a bone defect 2 (bone defect) of a bone, in particular a jaw bone 3. In this figure, the attachment 4 is in the form of a shaped body, e.g. formed from human or animal bones and has a the bone defect facing wall 9 and a bone defect facing away from the wall 11, which corresponds to the shape of the regenerated bone, on. Between the wall 9 and the bone defect 2 there is an interior space 8 which is filled by the regeneration of the bone and / or by the introduction of autogenic, syngeneic, allogenic, xenogenic, synthetic and / or alloplastic material.

FIG. 5 shows a section of an attachment 4 whose wall 9 facing the bone defect has openings 12, whereby a net-like structure is created.

6 to 8 show various views of an article 4, which has a bone defect site facing wall 9 and a bone defect site facing away from the wall 11 with arranged on the edge 16 of the attachment 4 positioning means 13, a healthy bone facing wall 14 and a The wall facing away from the healthy bone 15 have. In the proper arrangement of the attachment 4 at the bone defect site, which is supported by the positioning means 13, the walls 14 facing a healthy bone touch the healthy bone, whereby the positioner 13 ensures a perfect fit of the attachment 4 sometimes. Even without arranging at least one fixing means, not shown in FIGS. 6 to 8, or at least until at least one fixing means is arranged in the bone defect site, it is ensured. In order to easily remove the attachment 4 after the bone regeneration, this predetermined breaking points 17, whereby it can be divided into two parts after their separation for its removal.

FIG. 9 shows an attachment 4 arranged at a bone defect 2 of a jaw bone 3 having teeth 18, which is shown in detail. This shows that the attachment 4 is preferably arranged only in the area of the bone defect 2 of the jaw bone 3, so that it has a healthy appearance Bones 19 neither overstretched nor touched. Thus, only arranged on the attachment 4 positioning 13 have contact with the healthy bone 19th

FIGS. 6 to 9 show an attachment 4 whose wall 9 facing the bone defect corresponds to the shape of the regenerated bone. It is also conceivable that the positioning means 13 are arranged on the attachment 4 such that its wall facing away from the bone defect 11 corresponds to the shape of the regenerated bone. This could be accomplished, e.g. by arrangement of the positioning means 13 on the side facing away from the bone defect wall 11 of the attachment. 4

All features shown here may be essential to the invention both individually and in any combination. LIST OF REFERENCE NUMBERS

1 device

2 bone defect site

3 jawbone

4 essay

5 fixative

6 hole

7 hole

8 interior

9 wall

10 gums

11 wall

12 opening

13 positioning means

14 wall

15 wall

16 edge

17 breaking point

18 tooth

19 Healthy Bone

Claims

claims

1. device (1) for covering and / or reconstruction of a bone defect site (2),

- with an attachment (4) having an edge (16) and a wall facing away from the defect (11) and a bone defect facing wall (9),

- with if necessary. at least one fixing means (5) for fixing the attachment (4) to a bone,

wherein the attachment (4) consists of a dimensionally stable material and a bone defect facing wall (9) of the attachment (4) or a bone defect facing away wall (11) of the attachment (4) corresponds to the shape of the regenerated bone,

characterized,

in that at least one positioning means (13) having a wall (14) facing a healthy bone (19) adjacent to the bone defect is arranged on the edge (16) of the attachment (4).

2. Device (1) according to claim 1, characterized in that the attachment (4) and / or at least one fixing means (5) and / or at least one positioning means (13) at least partially consist of a biocompatible material.

3. Device (1) according to claim 2, characterized in that the material of the attachment (4) of organic or inorganic origin and / or the material of a fixing agent (5) of organic or inorganic origin and / or the material of a positioning ( 13) is of organic or inorganic origin.

4. Device (1) according to any preceding claim, characterized in that the attachment (4) and / or at least one fixing means (5) and / or at least one positioning means (13) at least partially consist of a biodegradable material.

5. Device (1) according to any preceding claim, characterized in that the attachment (4) and / or at least one fixing means (5) and / or at least one positioning means (13) at least partially consist of a resorbable material.

6. Device (1) according to any preceding claim, characterized in that the attachment (4) and / or at least one fixing means (5) and / or at least one positioning means (13) at least partially consist of a polymer or a polymeric compound.

7. Device (1) according to any preceding claim, characterized in that the attachment (4) and / or at least one fixing means (5) and / or at least one positioning means (13) consist at least partially of polylactide.

8. Device (1) according to any preceding claim, characterized in that the attachment (4) has a varying wall thickness and / or at least one positioning means (13) has a varying wall thickness.

9. Device (1) according to claim 8, characterized in that the wall thickness is at least 0.2 mm.

10. Device (1) according to any preceding claim, characterized in that the fixing means (5) is a pin, a screw, a nail and / or a bone adhesive.

11. Device (1) according to any preceding claim, characterized in that the attachment (4) has at least one milling.

12. Device (1) according to claim 11, characterized in that the milling corresponds to the fixing means (5).

13. Device (1) according to any preceding claim, characterized in that the bone defect facing wall (9) has a surface conditioning.

14. Device (1) according to claim 13, characterized in that the surface conditioning has a microstructuring, pores, osteoblast-loosening agents, means for promoting bone growth and / or BMP-containing bone substitute.

15. Device (1) according to any preceding claim, characterized in that the attachment (4) has at least one opening.

16. Device (1) according to any preceding claim, characterized in that the attachment (4) has at least one predetermined breaking point (16).

17. Device (1), according to a preceding claims, characterized in that the attachment (4) has at least one fastening device for at least one implant to be placed.

18. Device (1) according to claim 17, characterized in that at least one fastening device by a part of the attachment (4), which is connected by means of at least one predetermined breaking point (16) with the remaining part of the attachment (4), at least partially covered is.

19. Device (1) according to any preceding claim, characterized in that between the attachment (4) and a positioning means (13) at least one predetermined breaking point (16) is arranged.

20. A method for producing an attachment (4) of a covering device for a bone defect (2), comprising the following method steps:

- recording a first data set that represents the affected bone defect site (2) in its current state,

Comparing the first data set with a second data set representing the desired state of a bone regenerated at the bone defect site (2), the second data set being obtained by calculation or taken at a time when the bone is at the site to be regenerated was still a healthy bone (19),

- Use of the first data set and the second data set for planning the article (4), which has an edge (16) and a bone defect facing away from the wall (11) and the bone defect facing wall (9), and if necessary. with at least one fixing means (5) can be fixed to a bone,

- Implement planning of the essay (4) into a planning dataset and

- Supplying the planning data set to a manufacturing process, in particular to a computer-controlled manufacturing process, in which the article (4) is formed from a dimensionally stable material and the bone defect facing wall (9) or its bone defect facing away from the wall (11) of the shape of the regenerated bone in the desired state corresponds, wherein during the manufacture of the attachment (4) on the edge (16) of the attachment (4) at least one positioning means (13) is arranged, which is for positioning of the attachment (4) to a healthy bone (19) adjacent to the bone defect (2), a positioning means (13) facing away from the healthy bone (19) and the healthy bone (19) Having at least partially corresponding facing wall (14).

Method according to claim 20, characterized in that the recording of the first data set represents the affected bone defect site (2) in its three-dimensionality and / or the recording of the second data set represents the shape of the still healthy bone (19) in its three-dimensionality ,

22. The method according to claim 20 or claim 21, characterized in that the recording of the first data set and / or the recording of the second data set is carried out by at least one imaging method.

23. The method according to any one of claims 20 to 22, characterized in that the recording of the first data set and / or the recording of the second data set with at least one method which allows a three-dimensional representation of a bone done.

24. A method for producing an article (4) according to any one of claims 20 to 23, characterized in that the recording of the record of the healthy bone (19) takes place after the healthy bone (19) is grown.

25. A method for producing an attachment (4) according to claim 24, characterized in that the record of the healthy bone (19) is stored on a storage medium for its later use.

26. A method for producing an article (4) according to any one of claims 20 to 25, characterized in that in the manufacturing process of the article (4) is formed by milling.

27. A method for producing an article (4) according to any one of claims 20 to 26, characterized in that during the manufacture of the article (4) at least one fastening device for at least one implant to be placed on the article (4) is arranged.

28. A method for producing an attachment (4), according to claim 27, characterized in that at least one fastening device by removing a portion of the article (4), which prior to removal by means of at least one predetermined breaking point (16) with the remaining part of the article ( 4) is uncovered.

29. A method for producing an article (4) according to any one of claims 20 to 28, characterized in that during manufacture of the article (4) at least one predetermined breaking point (16) on the article (4) is arranged.

30. A method for producing an article (4) according to any one of claims 20 to 29, characterized in that between the article (4) and a positioning means (13) at least one predetermined breaking point (16) is arranged.

31. A method for producing an article (4), according to any one of claims 20 to 30, characterized in that during the manufacture of the article (4), a cleaning and / or sterilization process is performed.

32. A method for producing an attachment (4), according to any one of claims 20 to 31, characterized in that the attachment in a device for covering and / or reconstruction of a bone defect site according to claims 1 to 19 can be used.