METHOD FOR PRODUCING AN ATTACHMENT PIECE OF A COVER DEVICE FOR A BONE DEFECT SITE, AND DEVICE FOR COVERING AND/OR RECONSTRUCTING A BONE DEFECT SITE

Abstract

A process for manufacturing a cap (4) which has at least one nominal breaking point (16) of a covering device for a bone defect site (2) and a device (1) for covering and/or reconstructing a bone defect site (2) are proposed, wherein through comparing a first data set which represents the affected bone defect site (2) in the actual condition with a second data set which represents the nominal condition of a regenerated bone at the bone defect site (2), wherein the second data set has been calculated or recorded at a time at which the bone at the site now to be regenerated was still a healthy bone (18) it is made possible that the regenerated bone produced through the regeneration of the bone defect point (2) has a shape which corresponds to the shape the bone had at the site to be regenerated when it was still healthy.

Claims

1: Process for manufacturing a cap (4) of a covering device for a bone defect site (2) comprising the following processing stages: recording of a first data set which represents the affected bone defect site (2) in the actual condition comparison of the first data set with a second data set which represents the nominal condition of a bone regenerated at the bone defect site (2), wherein the second data set is produced through calculation or is recorded at a time at which the bone at the now to be regenerated site was still a healthy bone (18), use of the first data set and the second data set for planning the cap (4), which comprises a wall (11) facing away from the bone defect and a wall (9) facing the bone defect and, if need be, can be fixed on a bone with at least one fixing means (5), conversion of the planning of the cap (4) in to planning data set and transferring the planning data set to a manufacturing process, more particularly a computer-controlled manufacturing process in which the cap (4) is made of a dimensionally stable material and its wall (9) facing the bone defect or its wall (11) facing away from the bone defect site represents the shape of the regenerated bone in the nominal condition, wherein during and/or after manufacturing of cap (4) at least one nominal breaking point is arranged on the cap (4).

2: Process according to claim 1 wherein 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 form of the still health bone (18) in its three-dimensionality.

3: Process according to claim 1 wherein recording of the first data set and/or the recording of the second data set takes place by way of at least one imaging process.

4: Process according to claim 1 wherein the recording of the first data set and/or the recording of the second data set takes place by means of a process which allows three-dimensional representation of a bone.

5: Process for manufacturing a cap (4) according to claim 1 wherein the recording of the data set of the healthy bone (18) takes place after the healthy bone (18) has matured.

6: Process for manufacturing a cap (4) according to claim 5 wherein the data set of the healthy bone (18) is stored on a storage medium for later use.

7: Process for manufacturing a cap (4) according to claim 1 wherein in the manufacturing process the cap (4) is produced by way of milling.

8: Process for manufacturing a cap (4) claim 1 wherein during and/or after manufacturing of the cap (4) at least one fastening device is arranged on the cap (4) for fastening at least one implant to be inserted.

9: Process for manufacturing a cap (4) according to claim 8 wherein at least one fastening device is exposed by removing a part of the cap (4), which before being removed is connected by means of at least one nominal breaking point to the remaining part of the cap (4).

10: Process for manufacturing a cap (4) according to claim 1 wherein during and/or after the manufacturing of the cap (4) at least one positioning means (13) is arranged on the cap (4) which serves to position the cap (4) on a healthy bone (18) adjoining the bone defect site (2) on the cap (4) and which has a wall (15) facing away from the healthy bone (18) and a wall (14) facing the health bone (18) and at least partially corresponding therewith.

11: Process for manufacturing a cap (4) according to claim 10 wherein at least one nominal breaking point (16) is arranged between the cap (4) and a positioning means (13).

12: Process for manufacturing a cap (4) according to claim 1 wherein after manufacturing of the cap (4) a cleaning and/or sterilization process is carried out.

13: Device (1) for covering and/or reconstructing a bone defect site (2) with a cap (4) which as a wall (11) facing away from the bone defect site and a wall (9) facing the bone defect, with, if need be, a fixing means (5) for fixing the cap (4) to a bone, wherein the cap (2) is made of a dimensionally stable material which is at least partially in contact with the bone, and a wall (9) of the cap (2) 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, wherein the cap (4) has at least one nominal breaking point (16).

14: Device (1) according to claim 13 wherein the cap (4) and/or the fixing means (5) is/are at least partially made of a biocompatible material.

15: Device (1) according to claim 13 wherein the material is of organic and/or inorganic origin.

16: Device (1) according to claim 13 wherein at least one of the cap (4) and the fixing means (5) at least partially comprises a biodegradable material.

17: Device (1) according to claim 13 wherein at least one of the cap (4) and the fixing means (5) at least partially comprises a resorbable material.

18: Device (1) according to claim 13 wherein at least one of the cap (4) and the fixing means (5) comprises at least partially a polymer or a polymer compound.

19: Device (1) according to claim 13 wherein at leasdt one of the cap (4) and the fixing means (5) comprises at least partially polylactide.

20: Device (1) according to claim 13 wherein the cap (4) has a constant or a varying wall thickness.

21: Device (1) according to claim 20 wherein the wall thickness is at least 0.2 mm.

22: Device (1) according to claim 13 wherein the fixing means (5) is a pin, a screw, a nail and/or a bone adhesive.

23: Device (1) according to claim 13 wherein the cap (4) comprises at least one milling.

24: Device (1) according to claim 23 wherein the milling corresponds with the fixing means (5).

25: Device (1) according to claim 13 wherein the wall (9) facing the bone defect has undergone surface conditioning.

26: Device (1) according to claim 25 wherein the surface conditioning has a micro-structuring, pores, osteoblast attractants, means for promoting bone growth and/or bone replacement means containing BMP.

27: Device (1) according to claim 13 wherein the cap (4) comprises at least one opening.

28: Device (1) according to claim 13 wherein the cap (4) has at least one fastening device for at least one implant to be inserted.

29: Device (1) according to claim 28 wherein at least one fastening device is at least partially covered by a part of the cap (4) which is connected to the remaining part of the cap (4) by means of at least one nominal breaking point.

30: Device (1) according to claim 13 wherein for positioning the cap (4) on a health bone (18) adjoining the bone defect site (2) at least one positioning means (13) is arranged on the cap (4) which has a wall (15) facing away from the healthy bone and a wall (14) facing the healthy bone (18) and at least partially corresponding therewith.

31: Device (1) according to claim 30 wherein at least one nominal breaking point (16) is arranged between the cap (4) and a positioning means (13).

32: Device (1) for covering and/or reconstructing a bone defect site (2) with a cap (4) which as a wall (11) facing away from the bone defect site and a wall (9) facing the bone defect, with, if need be, a fixing means (5) for fixing the cap (4) to a bone, wherein the cap (2) is made of a dimensionally stable material which is at least partially in contact with the bone, and a wall (9) of the cap (2) 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, wherein the cap (4) has at least one nominal breaking point (16); and wherein the cap (4) is manufactured in accordance with the process for manufacturing a cap (4) according to claim 1.

Description

DRAWING

[0045] Examples of embodiment of the subject matter of the invention are set out in the drawing and will be explained in more detail below. Here:

[0046] FIG. 1 shows device according to the invention for covering and/or reconstructing a bone defect site

[0047] FIG. 2 shows a differently shaped device according to the invention for covering and/or reconstructing a bone defect site

[0048] FIG. 3 shows a differently shaped device according to the invention for covering and/or reconstructing a bone defect site

[0049] FIG. 4 shows a differently shaped device according to the invention for covering and/or reconstructing a bone defect site

[0050] FIG. 5 shows as section for a cap

[0051] FIG. 6 to 8 show various views of a cap with positioning means and

[0052] FIG. 9 shows a cap arranged on the bone defect site.

DESCRIPTION OF THE EXAMPLES OF EMBODIMENT

[0053] FIG. 1 shows a view of a device 1 according to the invention for covering and/or reconstructing a bone defect site 2 (bone defect) of a bone, in particularly a jaw bone 3. The device 1 comprises a cap 4, which is in one layer, and a fixing means 5, which in FIG. 1 is shown as a pin 1 arranged in the bone defect site 2. The cap 4 is made of a dimensionally stable material so that it is self-supporting and no additional support is required. For fixing the cap 4 (moulding shell, rigid shell) the fixing means 5 is pushed through a boring 6 in the cap 4 and is then introduced into the boring 7 in the jaw bone 3. Subsequent fixation of the cap 4 preferably takes place by way of ultrasonic welding. In the ultrasonic welding an ultrasound generator preferably produces a precisely defined frequency which is bundled via a sonotrode. After application of the resorbable fixing means 5 (pin) to a drilled hole (boring 7) in the bone, a produced oscillation fluidises the pin surfaces at their edges which brings about sliding of the pin into the boring. Through changing the state of the generator the pin also penetrates into the osseous cavities which a conventional bone screw cannot usually reach so that a high initially stability is achieved. The pin 4 also combines with the cap 4 and through a blocking mechanism ensures a stable three-dimensional structure. During the ultrasonic welding the fixing means 5 is thus softened so that it combines with the jaw bone 3 and the cap 4. Through the affixed cap 4 a sealed-off inner space 8 is formed between the jaw bone 3 and the cap 4 which is filled through the regeneration of the bone and/or through the introduction of a material of organic and/or inorganic origin, which can also be an autogenic, syngenic, allogenic, xenogenic, synthetic and/or alloplastic material, so that the regenerated bone or the introduced material corresponds to the shape of the wall 9 (surface) of the cap facing bone defect site 2. In order to accelerate the regeneration process of the jaw bone 3, the wall 9 of the cap 4 facing the bone defect can have undergone surface conditioning (e.g. micro-structuring, pores, osteoblast attractants, means for promoting bone growth and/or bone replacement means containing BMP).

[0054] FIG. 2 shows a view of a differently shaped device 1 according to the invention for covering and/or reconstructing a bone defect site 2 (bone defect) of a bone, in particular a jaw bone 3. In this figure the gums 10 are also indicated.

[0055] FIG. 3 shows a view of a differently shaped device 1 according to the invention for covering and/or reconstructing a bone defect site 2 (bone defect) of a bone, in particularly a jaw bone 3. In this figure the cap 4 is in the form of a moulded body, e.g. made of human or animal bone, and has a wall (surface) 9 facing the bone defect, which is adapted to the relief of the bone defect site 2, and a wall 11 (surface) facing away from the bond defect site 2 which corresponds to the shape of the regenerated bone.

[0056] FIG. 4 shows a view of a differently shaped device 1 according to the invention for covering and/or reconstructing a bone defect site 2 (bone defect) of a bone, in particularly a jaw bone 3. In this figure the cap 4 is in the form of a moulded body, e.g. made of human or animal bone, and has a wall 9 facing the bone defect and a wall 11 facing away from the bone defect site which corresponds to the shape of the regenerated bone.

[0057] Between the wall 9 and the bone defect 2 is an internal space 8 which is filled through the regeneration of the bone and/or through the introduction of autogenic, syngenic, allogenic, xenogenic, synthetic and/or alloplastic material.

[0058] FIG. 5 shows a section of a cap 4 the wall 9 of which facing the bone defect has an opening 12 through which a net-like structure is formed.

[0059] FIGS. 6 to 8 shows various views of a cap 4 which has a wall 9 facing a bone defect site and a wall 11 facing away from the bone defect site, with positioning means 13 which have a wall 14 facing a healthy bone and a wall 15 facing away from the healthy bone. When the cap 4 is correctly arranged on the bone defect site the walls 14 facing a healthy bone are in contact with the healthy bone through which by way of the positioning means 13 a perfect fit of the cap 4 is guaranteed. In order to be able to easily remove the cap 4 after bone regeneration it has a nominal breaking point 16 wherein after cutting through this it can be divided into two parts for removal.

[0060] FIG. 9 shows a cap 4 arranged on a bone defect site 2 of jaw bone 3 having teeth 17 which is shown as an excerpt. Through this it can be seen that the cap 4 is preferably only arranged in the area of the bone defect site 2 of the jaw bone 3 so that it neither bridges nor contacts a healthy bone 18. Only the positioning means 13 arranged on the cap 4 are thus in contact with the healthy bone 18.

[0061] Shown in FIG. 6 to 8 is a cap, the wall 9 of which facing the bone defect corresponds to the shape of the regenerated bone. It is also conceivable for the positioning means 13 to be arranged on the cap 4 in such a way that its wall 11 facing the bone defect corresponds to the shape of the regenerated bone. This could be brought about, for example through arranging the positioning means 13 on the wall 11 of the cap 4 facing away from the bone defect.

[0062] All the features set out here can be essential to the invention either alone or also in any combination with each other.

LIST OF REFERENCE NUMBERS

[0063] 1 Device

[0064] 2 Bone defect site

[0065] 3 Jaw bone

[0066] 4 Cap

[0067] 5 Fixing means

[0068] 6 Boring

[0069] 7 Boring

[0070] 8 Interior space

[0071] 9 Wall

[0072] 10 Gums

[0073] 11 Wall

[0074] 12 Opening

[0075] 13 Positioning means

[0076] 14 Wall

[0077] 15 Wall

[0078] 16 Nominal breaking point

[0079] 17 Tooth

[0080] 18 Healthy bone