Vorverbundene mehrschichtige Folie zur Abdeckung einer Knochendefektstelle

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[0001] The invention relates to a multilayer film according to the preamble of claim 1 for covering a bone defect.

[0002] Known films or membranes for covering bone defect sites are used for example in the range of jaw bone for [...], to rebuild bone loss or bone loss can occur in the case of a jaw bone, or as a result of an inflammatory process in the extraction of a tooth of a natural tooth,. Such films often exhibit a mold structure of titanium on, the is is arranged on a running the bone defect arises teflon diaphragm integrally formed, so that a cavity between the foil and the bone defect, in the bone material can grow again tooth retaining apparatus and wherein also the natural teeth. The attachment of the film takes place usually with resorbable or metal Pins or screws, are fastened through the jaw bone by the film. Alternatively, the foil can also be glued to the base or with the jaw bone. In simultaneously introduced can also be secured on the implant head the film implants. Since the bone regeneration takes several months, a second operation is needed after the bone synthesis with a teflon diaphragm, the film or. teflon diaphragm again to remove from the body.

[0003] it is the purpose of the invention, the previously described disadvantages and as opposed to that of the multilayer film to avoid State of the Art improved preconnectorized shall be indicated. A further operation is to be avoided, in particular, for removing of the film.

[0004] This problem is solved according to the invention by the features of claim 1. Advantageous configurations of the invention are recited in the dependent claims.

[0005] Under of the invention is therefore provided that the film has a shaping mold layer for development of the film comprises at least a cover layer for covering the bone defect and to the bone defect, wherein the mold layer and said at least one coating layer are substantially completely resorbable.

[0006] This that thus the film or membrane as a whole completely is resorbable in the body, for example by hydrolysis in the body is being dissolved, performing a further operation for the removal of the film is omitted. In other words an operation for attaching the film is strictly necessary.

[0007] The film comprises a shaping mold layer, the film serves to the bone defect through which a cavity and the shaping of the film can be formed between and bone defect, so that bone growth can take place in this cavity. For a convenient and/or carrier for medicines bone regeneration the cavity can also bone replacement materials, growth factors and/or other bone formation-promoting and protective substances contain the healing and. The cavity spatial image-endspaceholding mold layer is obtained by the upright and as long as, until the cavity is filled by regenerating bone material.

[0008] Moreover, said film comprises at least a cover layer for covering the bone defect. This cover layer, for example, may be designed as a diaphragm, serves for covering and sealing the bone defect, so as to avoid the penetration of soft tissue into the bone defect. To glued to improve the attachment of the film and the seal may be formed the bone defect further, the at least one facing sheet also so, to cooperate with a the gums surrounding bone defect.

[0009] This that the shaping mold layer and the at least one face layer is provided as already preconnectorized multilayer film, a readily workable film for covering a bone defect occurs, which connects the sealing properties of the top layer and the properties of the mold layer with the spatial image-end[...]

on addition is substantially completely absorbed in the body. The individual layers of the proposed film (mold layer and at least one cover layer) can be linked together mechanically and/or chemically. Therefore, it can preferably be provided that the mold layer and said at least one coating layer are connected with each other mechanically and/or chemically.

[0010] in accordance with a preferred embodiment it can be provided that the mold layer and said at least one coating layer are substantially completely resorbable in different time periods. For example, be achieved by interpretation of the mold layer and the at least one face layer that the mold layer faster than the resorbed at least one face layer. Generally, arise by different strength absorbablenesses the mold layer and the at least one face layer large freedoms in the interpretation of the film with respect to their resorption capacity.

[0011] There can be provided that the film as a whole in a period of about 3 to 12 months, preferably about 4 to 6 months, substantially completely is resorbable. This is the period within which is normally the bone reconstruction takes place.

[0012] To a good moulding onto the bone defect and a stable void formation between film and to allow bone defect, it can be provided that the mold layer is formed more rigid than the at least one face layer. The higher stiffness of the mold layer serves here thereto, to form a cavity for the bone synthesis and time necessary to obtain this cavity also for the upright for the bone regeneration. Through a lower rigidity compared to the mold layer of the at least one cover layer, in turn, may be achieved a good covering and sealing the bone defect.

[0013] Preferably, it can be provided that the mold layer, optionally together with the at least one face layer, mechanically and/or thermally and/or chemically formed is deformable. So may in particular be constructed as a substantially dimensionally stable layer said mold layer, the has can be under mechanical, thermal or chemical influence deform and after this deformation, in turn, a sufficient form stability, to obtain for the period of time required for bone growth to be formed the upright cavity. The at least one face layer may be flexible and preferably elastic, so as to allow a good cover and seal the bone defect.

[0014] A mechanical deformation can be carried out here, for example, by bending with a forceps. This is particularly for relatively thin (e.g. 0.5 mm in the range of about 0.10 mm to about) form layers an appropriate method of the projection. For form layers (e.g. thicker than about 0.5 mm) thicker a thermal distortion can be appropriate for forming a mold layer. A corresponding thermal deformation thermal staff with a hot tip or surface, by way of example, by means of a can, over heated in the hot water bath with sterile saline or prefabricated models are achieved.

[0015] For a good resorption capacity of the proposed film is provided that the at least one covering layer at least partially, preferably substantially completely is made of a bioabsorbable Collagenic material. It is intended that the bioresorbable Collagenic material type-I-collagen comprises collagen type-Ill-and/or. The Collagenic material can come, for example, from bovine hamstrings.

[0016] a good resorption capacity of the proposed film is also provided for that the mold layer at least partially, preferably substantially completely, consists of a bioabsorbable polymeric material. In the bioabsorbable polymer material also has to co-polymer material it can act.

[0017] It is provided that the bioresorbable polymer material lactic acid, preferably L-lactic acid, and/or derivatives thereof comprises. It is advantageous, if the proportion of [...]

Lactic acid in the bioabsorbable polymer material at least 70%, preferably about 80% to 95%, particularly preferably substantially about 82% is.

[0018] can also be provided that the bioresorbable polymer material comprises glycolic acid. It is advantageous, if the proportion of the glycolic acid in the bioabsorbable polymer material at most 30%, preferably about 15% to 20%, particularly preferably substantially about 18% is. Depending on the composition of the mold layer can be achieved that the mold layer is substantially dimensionally stable and yet substantially completely resorbable.

[0019] In a further preferred embodiment it can be provided that the mold layer and said at least one coating layer have different laminar extensions. This may be provided, a smaller surface area than the at least one face layer assumes that the mold layer. Due to their smaller surface area the mold layer covers the at least one face layer If, a particularly good cover can be achieved and thus also sealing the bone defect.

[0020] Preferably, it can be provided that the at least one cover layer and/or the mold layer is formed or are flat substantially continuous. A for the projection on the bone defect favorable contour of the film can be achieved, by way of example, by appropriately cutting the film.

[0021] It is provided that the mold layer for projection on the bone defect has a mold structure. This may be provided that said forming structure at least in part a with a convex and/or concave curved edge and/or at least in sections has a convex and/or concave curved shape. The mold structure may have flat-convex In other words, for example, have a convex and/or concave curved-projections and/or concavely curved edge and thus. Alternatively or additionally can have a convex and/or concave and the mold structure as a whole has a correspondingly curved shape.

[0022] It is provided that said forming structure comprises at least one strut-like structural [...]. The [...] in this case can be formed on the strut-like or flap-shaped in the manner of a bow and any cavity mould allow bone defect.

[0023] especially advantageous, depending on the embodiment is of the invention, in which the mold structure is formed substantially in the shape of a lattice. The latticed mold structure forms a reinforcing grid in this case, the the formation of a plurality of arbitrary allows cavity molds.

[0024] It may also be provided that said forming structure is formed by at least one reinforcement of the mold layer. In particular, when the mold layer in the form of a hardening liquid or a curing gel to said at least one coating layer is applied, it is favourable, when the mold structure only by the application of more liquid or gel in the region of the mold structure can be achieved. In this case can have different thicknesses, for example, the mold layer.

[0025] One particular design variant provides that the film has a carrier layer for at least one substance has to be arranged or disposed thereon. In the on the support layer, this may be true of drugs or substances packaged to be arranged, and the healing bone formation-promoting growth factors and/or other protective substances act and. The carrier layer can be arranged on a side of the foil facing the bone defect and preferably at least partially, preferably substantially completely, are made of a bioresorbable Collagenic material.

[0026] It may also be provided that corresponding substances are directly mounted on the mold layer and/or the at least one face layer. It may also be provided that the a bone defect, side or. [...] surface of the film itself

serves as a support for the above-described substances, or by, for example, this page. Surface of the film has a corresponding roughness.

[0027] The proposed film or membrane can also be pre-cut and/or preformed provided depending on the application. This may take place, for example, a desired blank and/or a desired 3D- data processing-supported planning after a deformation of the sheet.

[0028] Additional details and advantages of the present invention are explained by means of the following description of the figures. It show:

[0029] 1 Fig.: an embodiment of the proposed before-connected multilayer film in a perspective exploded view,

[0030] 2 Fig.: a side view of the proposed before-connected multilayer film according to Figure 1,

[0031] Fig. 3-7: plan views of different embodiments of the proposed before-connected multilayer film,

[0032] Fig. 8-15: several embodiments of the proposed before-connected multilayer film in perspective exploded views,

[0033] 16 Fig.: a proposed preconnectorized multilayer film disposed on a bone defect of a jaw bone,

[0034] 17 Fig.: a proposed preconnectorized multilayer film disposed on a bone defect of a jaw bone with implant,

[0035] 18 Fig.: a proposed preconnectorized multilayer film disposed on a bone defect of a jaw bone with Implant, washer and posts,

[0036] 19 Fig.: a proposed preconnectorized multilayer film clamped in a groove a washer,

[0037] 20 Fig.: a proposed preconnectorized multilayer film clamped in a groove a washer and located at a bone defect of a jaw bone with Implant and posts,

[0038] 21 Fig.: a proposed preconnectorized multilayer film disposed on an a natural tooth and bone defect

[0039] 22 Fig.: a proposed preconnectorized multilayer film disposed on a bone defect around a natural tooth in a sectional view.

[0040] Figure 1 shows a perspective exploded view of a mold layer 1 1st The before-connected proposed multilayer film comprises two outer layers 3 and 4 and 4a film b. 4a and 4b formed is more rigid than the outer layers 3 mold layer The and 5 points to a mold structure. The [...][...] 7 comprises a plurality of 5 mold structure, which serve, the film 2 to form 1 (here not shown) via a bone defect, wherein the film is still present by the 1 7 11 the bone defect [...] to a well (see e.g. Figure 16) causes the straps 2 bone leaves. The mold structure is substantially lattice-like form and thus makes possible a total of 5 any desired surface shapes of the film the training 1, so that in conjunction with a bone defect 1 and 2 any cavity molds between film 2 to form bone defect.

[0041] 3 and 4a and 4b each consist of the cover layers The mold layer a bioabsorbable material, so that the film is substantially completely resorbable in the body 1 as a whole. By includes providing two cover layers 4a and 4b, between which the mold layer 3 is embedded is increasing especially the absorption rate and mechanical strength of the mold layer 3 control.

[...]

[0042] 4a and 4b can be, for example, the outer layers act For bioresorbable collagen membranes, the results on the one hand by their softness and adhere well able to cover 2 can, on the other hand, a bone defect with a well 13 2 surrounding gums the bone defect, so that a good tightness of the bone defect 2.

[0043] The 3 can consist, for example, of a bioabsorbable polymer material or mold layer co-polymer material. In particular, the mold layer 3 can include, for example, about 82% L-lactic acid and about 18% glycolic acid. Such a selection of material yields a substantially dimensionally stable mold layer 3, the for projection on a bone defect 2 mechanically, thermally and/or chemically may be made deformable, wherein the mold layer is dimensionally stable after such deformation substantially in turn 3. Due to the rigidity and dimensional stability of the mold layer 2 3 1 and a bone defect can thus a cavity between the film and for the period of bone regeneration also created for the bone regeneration are held.

[0044] Figure 2 shows a side view of the multilayer film 1 according to Figure 1 before-connected.

[0045] Figure 3 shows a top view of a further variant of the proposed film 1, the two layers is carried out in this example comprises 4 3 and a covering layer and a mold layer. Both the mold layer 4 are substantially flat and the cover layer 3. The film 1 can be tailored as desired, to allow a good projection on a bone defect 2 depending on the application.

[0046] Figure 4 and Figure 5 show two further embodiments of a proposed two-layer film 1 with different outer contours of the cover layer 5 of the mold layer 4 and differently formed molding structures 3.

[0047] Figure 6 and Figure 7 show additional examples of proposed films 1, wherein in the examples shown here the mold layer 4 was applied on the cover layer 3 in each case in the form of a gel which has hardened and to subsequently. The form layers 5 3 each comprises a mold structure here shown, for example, has been achieved thereby that in the regions of the mold structure has been applied more gel 5, so that the 3 have different layer thicknesses form layers. In the area 5 has a greater layer thickness on a mold structure than in the other regions a in each case 3 mold layer of the mold layer 3.

[0048] Figure 8a Figure 15 show further embodiments in each case a perspective exploded view a proposed film 1. The in Figures each downwardly facing side 2,1 is the a bone defect 9 of a film 1 9 of the film side.

[0049] 8 and Figure 9 are composed of two layers The examples of Figure 3 and a cover layer 4 and each comprises a mold layer, wherein the mold layer 4 occupies a smaller surface area than the cover layer 3. 10 and Figure 11 are composed of three layers The examples of Figure and comprise a support layer 3 and a covering layer 8 respectively adjacent to a mold layer 4, on the substances such as drugs, growth factors and/or other protective substances may be applied and promoting the healing and bone formation.

[0050] 12 to 15 each have a mold layer The examples of Figures 3 and in each case two cover layers 4a Figure 4b on and, wherein the mold layer 4a and 4b 3 occupies a smaller surface area than the cover layers. The examples of Figure 13 to 15 each have in addition a support layer 8 on Figure, the with corresponding substances (as above described to Figure 10 and Figure 11) can be equipped.

[0051] Figure 16 shows a sectional view of a jaw bone to the bone defect with a bone defect 11 2 2 to allow a bone synthesis. To, a proposed preconnectorized multilayer film 1 on the bone defect is [...] 2

by means of corresponding fastening devices 11 and 12 to the jaw bone anchored response integrally formed. In the fastening devices 12 it can act, for example, budget resorbable nails. In forming cavity 2 or 1 and 10 between film bone defect. Jaw bone carrier composition can 11 and/or bone replacement materials, growth factors and/or other natural teeth for promoting the healing and bone formation and form a protective substances be contained and tooth retaining apparatus, so as to promote the bone regeneration. After attachment of the film 1 is removed or recessed gums previously sewn 13 again across the film 1 and correspondingly covered. Due to the resorption capacity of the film 1 and the fastening devices 12 no further operation is necessary, in order to remove the film 1 and/or the fastening devices 12 again after the bone synthesis.

[0052] Figure 17 shows a bone defect 16 similar to the of Figure 2 is covered with a proposed film 1. In this example was inserted into the remaining jaw bone 14 an implant 11, the free end of which is equipped with a screw 15. For a facilitated accessibility to the implant can be provided in this case 14 or its screw 15 is provided with a pre-punched hole that the film already 1,15 by which the screw may pass.

[0053] Figure 18 shows a further example of a bone defect 2 is covered with a proposed film 1. In the jaw bone 14 used is already an implant 11,16 is arranged at the free end of a post. The posts 1 projects both by the film 16, as well as by the gums 13 therethrough, to facilitate a further structure of tooth. In addition a washer 16 and foil 18 1 is disposed between posts. This washer 18 a closure 1 in that region of the film or a seal of the film can be achieved 1, through which the post 1 penetrates through the film 16 (penetration region). This is, on the one hand, important, with respect to the oral cavity to seal the film and thus to inhibit the formation of inflammation 1. On the other hand is also thereby able to be achieved that the film more slowly resorbed 1 in exactly this sensitive and thus this area can better protect penetration region. The washer 18 can here consist of titanium, and 14 project radially from the implant. The shape of the washer 18 can, for example, be round or oval. The washer 18 can also be constructed cutable, so as to be able to bring about optimum closure of the to stabilize penetration range by the film depending on the application or around the sensitive defective area around the implant 1 14. Heat to washer 18 may also be so constructed that the film 18 in a groove of the washer 1 can be clamped and pressed as required, to ensure a stabilization.

[0054] Fig. 19 shows a film 1, the clamped and is pressed in a groove a washer 18 of 20 the arrangement 1 and 2 shows this film at a bone defect Fig.. In the shown example the upper end 14 of the implant (implant head) 11 not projects beyond the jawbone, but is located below the bone level. Depending on, how deeply the upper end of the implant 11 is or how great the difference in level between implant head 14 in the jaw bone is bone level and, a balance can be created by different high stakes 19, so that the film can be fixed without crater formation 1 or washer 18. Figure 21 shows an example of a bone defect 17 2 a natural tooth is covered with a proposed film 1. In this example it is the application of the proposed film 2 from the film 1 for covering a periodontal bone defect 11 and 1 covered portions of the jaw bone. The 17 of the tooth are [...] represented.

[0055] Figure 22 shows a sectional view of a jaw bone with a bone defect around a natural tooth 11 2 17 a bone synthesis and/or build-up of the. To tooth retaining apparatus at 2 to allow the bone defect, a proposed preconnectorized multilayer film 1 on the bone defect is integrally formed by means of corresponding fastening devices 2 and the tooth 11 12 17 corresponding to and anchored to the jaw bone. In [...] it can be, e.g., 12 the fastening devices

resorbable nails act. In forming cavity 2 or 1 and 10 between film bone defect. Jaw bone carrier composition can 11 and/or bone replacement materials, growth factors and/or other natural teeth for promoting the healing and bone formation and form a protective substances be contained and tooth retaining apparatus, so as to promote the bone regeneration. After attachment of the film 1 is removed or recessed gums previously sewn 13 again across the film 1 and correspondingly covered. Due to the resorption capacity of the film 1 and the fastening devices 12 no further operation is necessary, in order to remove the film 1 and/or the fastening devices 12 again after the bone synthesis.