IMPLANT FOR COVERING MAXILLARY BONE DEFECTS IN THE JAW REGION AND METHOD FOR PRODUCING THE SAME
20180036127 ยท 2018-02-08
Assignee
Inventors
Cpc classification
A61L2430/02
HUMAN NECESSITIES
A61L31/088
HUMAN NECESSITIES
A61L31/148
HUMAN NECESSITIES
A61F2240/00
HUMAN NECESSITIES
A61L31/14
HUMAN NECESSITIES
International classification
Abstract
The invention relates to an implant for covering bone defects in the jaw region, which comprises a magnesium film.
Claims
1. An implant for covering bone defects in a jaw region, comprising a magnesium film with a thickness between 50 and 300 m.
2. The implant of claim 1, wherein the implant is geometrically stable and has a curved shape with a radius of curvature from 0.5 to 10 cm.
3. The implant of claim 1, wherein the implant has at least one recess for a tooth.
4-5. (canceled)
6. The implant of claim 1, wherein the implant has a magnesium fluoride layer with a thickness of less than 5 m.
7. The implant of claim 1, wherein the film has no openings, at least in a central area thereof.
8. The implant of claim 1, wherein the implant is structured or perforated along a peripheral area thereof.
9. (canceled)
10. The implant of claim 1, wherein the magnesium film contains less than 500 ppm of iron, copper, or nickel.
11. A kit for covering bone defects in a jaw region, comprising the implant of claim 1, and pins, screws, or sutures for fixing the implant in the jaw.
12-15. (canceled)
16. A method for cosmetic or surgical jaw reconstruction, comprising the steps of: providing an implant in the form of a film having a thickness between 50 and 300 m and predominantly containing magnesium; cutting the implant to a size appropriate for covering a defect site in a jaw region to be covered; bending the implant into a curved shape; placing the implant over the defect site in the jaw region; and closing soft tissue over the implant.
17. The method of claim 16, wherein the implant has a thickness between 70 and 200 m.
18. The method of claim 16, wherein the implant further contains less than 500 ppm of iron, copper or nickel.
19. The method of claim 16, wherein the implant further contains from 1 to 6% of yttrium, from 0.5 to 3% of zinc, from 0.1 to 2% of calcium or from 0.6 to 1.5% of manganese.
20. The method of claim 16, wherein prior to the placing of the implant, further comprising the step of filling the defect site with a bone substitute material or bone graft.
21. The method of claim 16, further comprising the step of fixing the implant in the jaw with at least one fastener.
22. The method of claim 21, wherein the at least one fastener comprises a pin, a screw, or a suture.
23. The method of claim 16, wherein the step of cutting to size comprises providing at least one recess for a tooth in an edge of the implant.
24. The method of claim 16, wherein the step of bending into a curved shape comprises bending the implant so as to form a radius of curvature between 0.5 and 10 cm.
25. The method of claim 24, wherein the implant is bent so as to form a radius of curvature between 0.7 and 1.5 cm.
26. The method of claim 16, wherein the step of bending into a curved shape comprises bending the implant about an angle of greater than 30.
27. The method of claim 16, wherein prior to the bending step, further comprising the step of subjecting the implant to a surface treatment comprising etching, coating, or passivating.
28. The method of claim 27, wherein the passivating comprises immersing the magnesium film into hydrofluoric acid so as to form a magnesium fluoride layer with a thickness of less than 5 m.
29. The method of claim 28, wherein the magnesium fluoride layer is formed with a thickness of less than 2 m.
30. The method of claim 16, wherein prior to the bending step, further comprising the step of structuring the implant along peripheral areas thereof.
31. The method of claim 30, wherein the structuring comprises producing at least one of bores, perforations, a mesh-like structure, and a pleated structure along peripheral areas of the implant.
32. The method of claim 16, wherein the defect site in the jaw region includes a jaw bone defect or a Schneiderian membrane defect.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0060] The subject matter of the invention will now be explained in more detail by way of exemplary embodiments with reference to the drawings of
[0061]
[0062]
[0063]
[0064]
[0065]
[0066]
DETAILED DESCRIPTION OF THE DRAWINGS
[0067]
[0068] In this exemplary embodiment, the implant 1 consists of a magnesium film 2 of a thickness from 50 to 150 m, which is in particular made of a magnesium alloy. Implant 1 has rounded corners, and in this exemplary embodiment it has two recesses 3 which are intended for an adjacent tooth.
[0069] Thus, the implant is in particular designed for covering a defect site in the jaw, where one tooth or several teeth are missing.
[0070]
[0071] It can be seen that the implant is curved. In this exemplary embodiment, the longitudinal edge portions of the implant are almost opposed to each other, so that the implant can be fixed on a jaw ridge, in particular clamped or clipped thereon.
[0072]
[0073] On the one hand, the implant 1 has bores 5 which are used to introduce sutures, pins, screws, or nails.
[0074] In this exemplary embodiment the implant 1 furthermore has a mesh-like area 7, that is to say an area with perforations. These perforations may serve to facilitate the bending or for improved adhesion to the tissue.
[0075] Furthermore, a structured area 6 is also shown, which may in particular be in the form of a pleating and serves to conform the implant 1 to the jaw bone.
[0076]
[0077] The result is a smooth scratch-resistant thin layer of approximately 1 m thickness, which allows for even rather narrow bending radii.
[0078]
[0079]
[0080] The thin magnesium fluoride layer 9 formed on the magnesium layer 8 can be seen.
[0081] It is readily apparent that the magnesium fluoride layer 9 is well interlocked with the underlying magnesium layer, which is probably the cause for the good adhesion of the layer, inter alia.
[0082]
[0083] The implant of the invention in the form of a magnesium film can be employed for the treatment of injured Schneiderian membranes.
[0084] In particular when pin implants 14 are placed, as illustrated here, which serve to receive a dental implant, injury may occur to the Schneiderian membrane 12 which separates the maxillary bone 13 from the maxillary sinus.
[0085] In many cases, as illustrated here, an interspace between the jaw bone 13 and the Schneiderian membrane 12 is filled with a bone substitute material, in particular a calcium phosphate granulate, in order to increase the thickness of the receding jaw bone so that the implant 14 can be placed.
[0086] Injury to the Schneiderian membrane 12 is accompanied by an extremely high risk of infection. If, during surgery, such an injury is detected, the surgical procedure is usually interrupted, and only after a healing period of several months the pin implant 14 is again tried to be placed.
[0087] It has been found that this can be avoided by using an implant according to the invention in the form of a magnesium film which closes the Schneiderian membrane 12.
[0088] For example, in case of a defect the magnesium film can be introduced either through the bores for the pin implants 14 or through a lateral opening of the jaw ridge 13.
[0089] It will be understood that if the magnesium film is introduced through the bores for the pin implants, it can be rolled up previously, for example.
[0090] The Schneiderian membrane 12 is sealed by the magnesium film. Surprisingly, already a thin magnesium film of at least 50 m provides sufficient sealing without decomposing within a very short period of time as would actually be expected.
[0091] Thus, the magnesium film can therefore allow to immediately continue the surgical procedure and moreover offers the advantage that the magnesium film, in particular if it is sufficiently thick, provides a good backing for the bone material used. The growth of natural bone tissue is also promoted by the magnesium film.
[0092] It will be understood, however, that the magnesium film may as well be used preventively, without an injury to the Schneiderian membrane.
[0093]
[0094] A jaw bone 10 which has a defect site 11 is covered with a bent implant 1 consisting of a magnesium film. The implant 1 defines a three-dimensional free-form surface.
[0095] As can be seen in the figure on the right, the bone tissue of the jaw ridge 10 that is being formed follows this free-form surface and forms a rounded jaw ridge which approximates the natural shape. This approximation will in particular usually be better than when using inserted bone blocks of donor material.
[0096] The invention permits to provide, in a straightforward way, a resorbable implant for covering bone defects in the jaw region.
LIST OF REFERENCE NUMERALS
[0097] 1 Implant [0098] 2 Magnesium film [0099] 3 Recess [0100] 4 Corner [0101] 5 Bore [0102] 6 Structured area [0103] 7 Mesh-like area [0104] 8 Magnesium layer [0105] 9 Magnesium fluoride layer [0106] 10 Jaw ridge [0107] 11 Defect site [0108] 12 Schneiderian membrane [0109] 13 Jaw bone [0110] 14 Pin implant [0111] 15 Filler material