DE102015006154A1 - Device for covering and / or reconstruction of a bone defect site; A method of making an attachment of a bone defect covering device - Google Patents

Abstract

A device (1) for covering and / or reconstruction of a bone defect site (2) and a method for producing an attachment (4) of a covering device for a bone defect (3) are proposed, the device (1) for covering and / or reconstruction a bone defect site (2) comprising an attachment (4) (shell mold, rigid shell, molded body) on which at least one positioning means (13) is arranged, and at least one fixing means (5) for fixing the attachment (4) to a bone, and the attachment (4) is characterized by a dimensionally stable (rigid) nature 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, wherein at least one positioning means (13) is arranged on the attachment (4).

Description

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 15.

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 endogenous bone particles. In order for the bone augmentation material to grow through substantially exclusively from the bone side, the recess becomes, as in the patent DE 43 02 708 C2 described, sealed with a cover membrane. The covering membrane is attached to the endogenous bone with fixing nails, whereby, since the covering membrane is made of a flexible material, the attachment requires the greatest degree of technical skill of the surgeon.

To overcome this disadvantage of a lack of support function of the cover membrane is described in the patent US 48 16 339 describes a covering membrane, which consists of several layers, which 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 is a biodegradable hollow body, which in particular has a hollow cylindrical or conical-cylindrical shape 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 a high accuracy of fit and stability, so that the treating physician can easily handle and implant. The implant bearing made of hydroxyapatite, which has a thin, in particular made of resorbable material membrane to protect the mucous membrane from mechanical effects and to protect the implant bearing from ingrowing tissue from the mucosal side of the mucous membrane on the side facing the mucosa, is produced by an anabolic manufacturing process , so that the material composition forms a "gradient structure" in the sense of a particular decreasing inward density. In this case, a construction with a particularly porous structure and on the outside of the implant bearing, on which there is a structure for holding a dental implant and / or a dental prosthesis, a compact design is provided on the bone-facing side.

Furthermore, in 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 and WO 2006/051401 A2 Devices for a bone defect site described, wherein all of these solutions have the disadvantage that they affect the existing next to the bone defect site healthy bones.

The invention and its advantages

The device according to the invention for covering and / or reconstructing a bone defect site, wherein the term "bone defect site" means a site of a (diseased, deformed, injured, altered by aging processes, altered by degeneration (eg after tooth extraction, tumor, etc.) and / or or 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 characterizing feature of claim 1 and the method according to the invention for producing an attachment of a bone defect covering device, with the characterizing features of claim 15, have the advantage that the device for covering and / or reconstructing a bone defect site consists of an attachment (eg Shell, molded body) and at least one fixing agent for fixing the attachment to e inem bone, wherein on the article, which is characterized by a dimensionally stable (rigid) texture and at least partially (at the edge) in contact with the bone and a bone defect facing wall (surface) of the essay or a bone defect facing away from the wall ( Surface) of the attachment of the shape of the regenerated bone, which has by its regeneration again in the form of a healthy bone corresponds, at least one positioning means is arranged. By the at least one positioning means is a positioning of the essay A healthy bone adjacent to the bone defect site is possible since the positioning means has a wall facing away from the healthy bone and a facing wall facing the healthy bone and at least partially corresponding thereto. Preferably, the attachment is arranged and / or fixed exclusively in the area of the bone defect site, so that it does not affect the bone adjacent to the bone defect site, at which, due to its health anyway no regeneration of the bone takes place. The attachment is thus preferably matched precisely to the bone defect site and preferably ends flush with the healthy bone.

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

According to an additional advantageous embodiment of the device according to the invention, the attachment and / or the fixing means may at least partially consist 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.

According to an additional advantageous embodiment of the device according to the invention, the attachment and / or the fixing 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 the fixing agent 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 article has a constant or a 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 there is a dimensional stability of the shell mold.

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 protect the healthy bone, the fixing agent is 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 plurality of openings, the attachment may at least in places have a network structure, wherein the bone defect facing away from the 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 essay 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 crushed into at least two parts due to the predetermined breaking point. The 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 remainder of the attachment.

According to an additional advantageous embodiment of the device according to the invention, the attachment has at least one fastening device (eg 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 (eg 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, z. B. after fixation of the essay or after the regeneration of the bone at the bone defect site, be removed from the possibly remaining essay.

• – Aufnahme eines Datensatzes, der die betroffene Knochendefektstelle in seiner Dreidimensionalität repräsentiert, mittels Tomografie oder ähnlichen bildgebenden Verfahren,
• – Verwendung des Datensatzes zur Planung des Aufsatzes, der eine dem Knochendefekt abgewandte Wandung und eine dem Knochendefekt zugewandte Wandung aufweist, und mit mindestens einem Fixiermittel an einem Knochen fixierbar ist,
• – Umsetzung der Planung des Aufsatzes in einen Planungsdatensatz und
• – Zuführung des Planungsdatensatzes an ein computergesteuertes Fertigungsverfahren,

wobei der Aufsatz aus einem formstabilen Material gebildet wird und dessen dem Knochendefekt zugewandte Wandung (Oberfläche) oder dessen dem Knochendefekt abgewandte Wandung (Oberfläche) der Form des regenerierten Knochens entspricht, und die Aufnahme des Datensatzes, der die betroffene Knochendefektstelle in seiner Dreidimensionalität repräsentiert, mittels Tomografie, Computertomografie, digitaler Volumentomografie, Sonografie odgl., erfolgt, wobei während und/oder nach der Fertigung des Aufsatzes an dem Aufsatz mindestens ein Positioniermittel angeordnet wird, das zur Positionierung des Aufsatzes an einem an die Knochendefektstelle angrenzenden gesunden Knochen an dem Aufsatz dient und das eine dem gesunden Knochen abgewandte Wandung (Oberfläche) und eine dem gesunden Knochen und mit diesem zumindest teilweise korrespondierende zugewandte Wandung (Oberfläche) aufweist, repräsentiert die Aufnahme des ersten Datensatzes die betroffene Knochendefektstelle (2) in ihrer Dreidimensionalität und/oder repräsentiert die Aufnahme des zweiten Datensatzes die Form des noch gesunden Knochens (18) in seiner Dreidimensionalität.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 bone defect facing wall (surface) or its bone defect facing wall (surface) corresponds to the shape of the regenerated bone, and the recording of the record representing the affected bone defect site in its three-dimensionality by means of Tomography, computed tomography, digital volume tomography, sonography or the like., Wherein and / or after the manufacture of the essay on the essay at least one positioning means is arranged, which serves for positioning of the essay at a bordering on the bone defect site healthy bone on the essay and which has a wall facing away from the healthy bone (surface) and a healthy wall and with this at least partially corresponding facing wall (surface), 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 ( 18 ) 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 already at the time of admission of the 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, at least one fastening device for at least one implant to be placed on the attachment is arranged during and / or after the manufacture of the article. 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, at least one fastening device (eg recess) is connected by removing a part of the attachment which, prior to removal, is connected to the remaining part of the attachment by means of at least one predetermined breaking point is 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 device for a bone defect site, at least one predetermined breaking point is arranged on the attachment during and / or after 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, 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 after 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 donor z. B. removed a bone block, 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.

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 may also be 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 (owner or donor) z. B. removed a bone block, 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 a representation of a device according to the invention for covering and / or reconstruction of a bone defect site,

2 1 is an illustration of a differently shaped device according to the invention for covering and / or reconstruction of a bone defect site,

3 1 is an illustration of a differently shaped device according to the invention for covering and / or reconstruction of a bone defect site,

4 1 is an illustration of a differently shaped device according to the invention for covering and / or reconstruction of a bone defect site,

5 a section of an essay,

6 to 8th various representations of an essay with positioning and

9 an attachment located at a bone defect site.

Description of the embodiment

1 shows a representation of a device according to the invention 1 for covering and / or reconstructing a bone defect site 2 (Bone defect) of a bone, especially a jawbone 3 , The device 1 consists of an essay 4 which is monolayer, and a fixative 5 , this in 1 shown as a pin in the bone defect site 2 is arranged. The essay 4 is made of a dimensionally stable material, so that it is self-supporting and no additional support is necessary. For fixing the attachment 4 (Form shell, rigid shell) becomes the fixative 5 through a hole 6 in the essay 4 pushed and then into the jawbone 3 arranged hole 7 introduced. The subsequent fixation of the essay 4 preferably takes place via ultrasonic welding. In ultrasonic welding, an ultrasonic generator preferably generates a precisely defined frequency, which is bundled via a sonotrode. After placing the absorbable fixative 5 (Pin) on a drilled hole in the bone (drilled hole 7 ) generates a generated oscillation for the liquefaction of Pinoberflächen at its edges, whereby a sliding of the pin is effected in 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 essay 4 and provides a locking mechanism for a stable three-dimensional construct. Ultrasonic welding thus becomes the fixative 5 softened so that it is with the jawbone 3 and the tower 4 combines. Through the fixed attachment 4 creates a sealed interior 8th between the jawbone 3 and the tower 4 which is filled by the regeneration of the bone and / or by introducing a material of organic and / or inorganic origin, which may also be an autogenous, syngeneic, allogenic, xenogeneic, synthetic and / or alloplastic material, so that the regenerated bone or the introduced material of the form of the bone defect site 2 facing wall 9 (Surface) of the tower 4 equivalent. To the regeneration process of the jawbone 3 To accelerate, the wall facing the bone defect 9 of the essay 4 surface conditioning (e.g., microstructuring, pores, osteoblast attractants, bone growth promoting agents, and / or BMP-containing bone substitute).

2 shows a representation of a differently shaped device according to the invention 1 for covering and / or reconstructing a bone defect site 2 (Bone defect) of a bone, especially a jawbone 3 , In this figure is in addition the gums 10 indicated.

3 shows a representation of a differently shaped device according to the invention 1 for covering and / or reconstructing a bone defect site 2 (Bone defect) of a bone, especially a jawbone 3 , In this figure is the essay 4 as a shaped body z. B. formed from human or animal bones and has a the bone defect facing wall 9 (Surface) attached to the relief of the bone defect site 2 is adapted, and a bone defect facing away from the wall 11 (Surface), which corresponds to the shape of the regenerated bone on.

4 shows a representation of a differently shaped device according to the invention 1 for covering and / or reconstructing a bone defect site 2 (Bone defect) of a bone, especially a jawbone 3 , In this figure is the essay 4 as a shaped body z. B. formed from human or animal bones and has a the bone defect facing wall 9 and a wall facing away from the bone defect 11 that corresponds to the shape of the regenerated bone. Between the wall 9 and the bone defect site 2 there is an interior 8th which is filled by the regeneration of the bone and / or by introduction of autogenous, syngeneic, allogeneic, xenogenic, synthetic and / or alloplastic material.

5 shows a section of an essay 4 whose wall facing the bone defect 9 openings 12 which results in a net-like structure.

The 6 to 8th show different representations of an essay 4 which is a wall facing a bone defect site 9 and a wall facing away from the bone defect site 11 having, with positioning means 13 which is a wall facing a healthy bone fourteen and a wall facing away from the healthy bone 15 exhibit. In the proper arrangement of the essay 4 at the bone defect site, the walls facing a healthy bone touch fourteen the healthy bone, resulting in the positioning agent 13 a perfect fit of the essay 4 is guaranteed. To the essay 4 easy to remove after bone regeneration, this predetermined breaking points 16 on which it can be divided into two parts after its separation for its removal.

9 shows one at a bone defect site 2 a fragmentally represented jawbone 3 , the teeth 17 has arranged essay 4 , This shows that the essay 4 preferred only in the area of the bone defect site 2 of the jawbone 3 is arranged so that he has a healthy bone 18 neither overstretched nor touched. Thus, only those on the essay 4 arranged positioning 13 Contact with the healthy bone 18 ,

In the 6 to 9 is an essay 4 shown, the bone defect facing wall 9 corresponds to the shape of the regenerated bone. It is also conceivable that the positioning 13 so on the essay 4 be arranged so that the bone defect facing away from the wall 11 corresponds to the shape of the regenerated bone. This could be done z. B. by positioning the positioning 13 on the wall facing away from the bone defect 11 of the essay 4 ,

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

LIST OF REFERENCE NUMBERS

1

contraption

2

Bone void

3

jawbone

4

essay

5

fixer

6

drilling

7

drilling

8th

inner space

9

wall

10

gums

11

wall

12

opening

13

positioning

14

wall

15

wall

16

Breaking point

17

tooth

18

Healthy bone

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• DE 4302708 C2 [0002]
• US 4816339 [0003]
• DE 102005039382 B4 [0004]
• DE 102006047054 A1 [0005, 0006]
• DE 19830992 A1 [0006]
• DE 102005060761 A1 [0006]
• DE 4226465 A1 [0006]
• WO 01/91818 A1 [0006]
• DE 102005041412 A1 [0006]
• WO 2006/051401 A2 [0006]

Claims (32)

Contraption ( 1 ) for covering and / or reconstruction of a bone defect site ( 2 ), - with an essay ( 4 ), which is a wall facing away from the bone defect ( 11 ) and a bone defect facing wall ( 9 ), - with ggfls. at least one fixing agent ( 5 ) for fixing the essay ( 4 ) on a bone, the attachment ( 4 ) consists of a dimensionally stable material which is at least partially in contact with the bone, and a wall facing the bone defect ( 9 ) of the article ( 4 ) or a wall facing away from the bone defect ( 11 ) of the article ( 4 ) corresponds to the shape of the regenerated bone, characterized in that the attachment ( 4 ) at least one positioning means ( 13 ) having. Contraption ( 1 ), according to claim 1, characterized in that the attachment ( 4 ) and / or the fixing agent ( 5 ) consist at least partially of a biocompatible material. Contraption ( 1 ), according to claim 1 or claim 2, characterized in that the material is of organic and / or inorganic origin. Contraption ( 1 ), according to any preceding claim, characterized in that the article ( 4 ) and / or the fixing agent ( 5 ) consist at least partially of a biodegradable material. Contraption ( 1 ), according to any preceding claim, characterized in that the article ( 4 ) and / or the fixing agent ( 5 ) consist at least partially of a resorbable material. Contraption ( 1 ), according to any preceding claim, characterized in that the article ( 4 ) and / or the fixing agent ( 5 ) consist at least partially of a polymer or a polymeric compound. Contraption ( 1 ), according to any preceding claim, characterized in that the article ( 4 ) and / or the fixing agent ( 5 ) consist at least partially of polylactide. Contraption ( 1 ), according to any preceding claim, characterized in that the article ( 4 ) has a constant or varying wall thickness. Contraption ( 1 ), according to claim 8, characterized in that the wall thickness is at least 0.2 mm. Contraption ( 1 ), according to any preceding claim, characterized in that the fixing agent ( 5 ) is a pin, a screw, a nail and / or a bone adhesive. Contraption ( 1 ), according to any preceding claim, characterized in that the article ( 4 ) has at least one milling. Contraption ( 1 ), according to claim 11, characterized in that the milling with the fixing ( 5 ) corresponds. Contraption ( 1 ), according to any preceding claim, characterized in that the wall facing the bone defect ( 9 ) has a surface conditioning. Contraption ( 1 ), According to claim 13, characterized in that the surface conditioning comprising a microstructure, pore, osteoblasts attractants, agents for promoting bone growth and / or BMP-containing bone substitute. Contraption ( 1 ), according to any preceding claim, characterized in that the article ( 4 ) has at least one opening. Contraption ( 1 ), according to any preceding claim, characterized in that the article ( 4 ) at least one predetermined breaking point ( 16 ) having. Contraption ( 1 ), according to any preceding claim, characterized in that the article ( 4 ) has at least one fastening device for at least one implant to be placed. Contraption ( 1 ), according to claim 17, characterized in that at least one fastening device by a part of the essay ( 4 ), which by means of at least one predetermined breaking point ( 16 ) with the remainder of the article ( 4 ) is at least partially covered. Contraption ( 1 ), according to any preceding claim, characterized in that between the article ( 4 ) and a positioning means ( 13 ) at least one predetermined breaking point ( 16 ) is arranged. Process for the preparation of an article ( 4 ) a covering device for a bone defect ( 2 ), comprising the following procedural steps: - recording of a first data set containing the affected bone defect site ( 2 ) in the actual state, - comparison of the first data set with a second data set, the desired state of the at the Bone defect site ( 2 regenerated bone, the second data set being created by calculation or taken at a time when the bone at the site to be regenerated is still a healthy bone ( 18 ), - use of the first record and the second record for planning the essay ( 4 ), which is a wall facing away from the bone defect ( 11 ) and a bone defect facing wall ( 9 ), and if necessary. with at least one fixing agent ( 5 ) can be fixed to a bone, - implementation of the planning of the essay ( 4 ) in a planning data record and - supply of the planning data record 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 wall facing away from the bone defect ( 11 ) corresponds to the shape of the regenerated bone in the desired state, wherein during and / or after the manufacture of the article ( 4 ) on the essay ( 4 ) at least one position means ( 13 ), which is used to position the attachment ( 4 ) at one of the bone defect sites ( 2 ) adjacent healthy bones ( 18 ), wherein a position means ( 13 ) a healthy bone ( 18 ) facing away wall ( 15 ) and a healthy bone ( 18 ) and with this at least partially corresponding facing wall ( fourteen ) having. A method according to claim 20, characterized in that the recording of the first data set affects 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 ( 18 ) in its three-dimensionality. Method according to claim 20 or claim 21, characterized in that the recording of the first data record and / or the recording of the second data record is carried out by at least one imaging method. Method, according to 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. Process for the preparation of an article ( 4 ), according to one of claims 20 to 23, characterized in that the recording of the record of the healthy bone ( 18 ) takes place after the healthy bone ( 18 ) is fully grown. Process for the preparation of an article ( 4 ), according to claim 24, characterized in that the record of the healthy bone ( 18 ) is stored on a storage medium for its later use. Process for the preparation of an article ( 4 ), according to one of claims 20 to 25, characterized in that in the manufacturing process of the article ( 4 ) is formed by milling. Process for the preparation of an article ( 4 ), according to one of claims 20 to 26, characterized in that during and / or after the manufacture of the article ( 4 ) at least one fastening device for at least one implant to be placed on the attachment ( 4 ) is arranged. Process for the preparation of an article ( 4 ), according to claim 27, characterized in that at least one fastening device by removing a part of the article ( 4 ), which before removal by means of at least one predetermined breaking point ( 16 ) with the remainder of the article ( 4 ) is exposed. Process for the preparation of an article ( 4 ), according to one of the preceding claims, characterized in that during and / or after the manufacture of the article ( 4 ) at least one predetermined breaking point ( 16 ) on the essay ( 4 ) is arranged. Process for the preparation of an article ( 4 ), according to one of claims 20 to 29, characterized in that between the article ( 4 ) and a position means ( 13 ) at least one predetermined breaking point ( 16 ) is arranged. Process for the preparation of an article ( 4 ), according to any one of claims 20 to 30, characterized in that after the manufacture of the article ( 4 ) a cleaning and / or sterilization process is performed. Process for the preparation of an article ( 4 ), according to one of claims 20 to 31, characterized in that the attachment can be used in a device for covering and / or reconstruction of a bone defect site according to claims 1 to 19.

Images