奥地利专利AT516116A1 Method for producing a multilayer film

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专利摘要:
Method for producing a multilayer film (1), in particular for covering a bone defect site (2), wherein the film (1) comprises at least one essentially completely bioresorbable covering layer (4, 4a, 4b), wherein the at least one covering layer (4, 4a , 4b) is applied to a thermally deformable and substantially completely bioresorbable mold layer (3), wherein the at least one cover layer (4, 4a, 4b) with the mold layer (3) thermally and / or mechanically connected, preferably compressed.
公开号:AT516116A1
申请号:T622/2014
申请日:2014-08-05
公开日:2016-02-15
发明作者:Dietmar Dr Sonnleitner
申请人:Dietmar Dr Sonnleitner；
IPC主号:

专利说明:

The invention relates to a method for the production of a multilayer film and to a multilayer film for covering a bone defect site, the sequence comprising at least one substantially completely bioresorbable covering layer.
Known foils or membranes for covering bone defect sites are used, for example, in the area of jawbone for jaw augmentation to rebuild a jaw bone in the case of bone loss or bone loss that may occur during extraction of a tooth or as a result of an inflammatory process around a natural tooth or implant. Such films often have a titanium structure which is placed on a Teflon membrane and which is formed via the bone defect site, so that a cavity is created between the film and the bone defect site, in which bone material and, in the case of natural teeth, also the periodontium can grow back. The film is usually attached to bioresorbable or metal pins or screws that are secured through the film to the jawbone. Alternatively, the film with the Unterlagebzw. glued to the jawbone. With simultaneously implanted implants, the foil can also be attached to the implant head. Since bone regeneration takes several months, a second operation is needed after bone cementation with a Teflon membrane to complete the sequence. Teflon membrane back out of the body to remove.
Cover layers of bioresorbable materials are also already known which are redissolved by the body due to their bioresorbability, for example by hydrolysis. However, such facings generally have too low a dimensional stability to allow and maintain a bone healing promoting structure during the period of bone healing. The use of such a facer in conjunction with a Teflon forming membrane in turn requires a second operation to return the Teflon membrane from the body remove.
The object of the invention is to avoid the above-described drawbacks and to specify over the prior art improved method for producing a multilayer film as well as an improved over the prior art multilayer film. In particular, another operation to remove the film should be avoided.
This object is achieved in the method according to the invention by the features of claim 1. Advantageous embodiments of the invention are specified in the dependent claims.
According to the invention, it is therefore provided that the at least one cover layer is applied to a thermally deformable and essentially completely bioresorbable molding layer, wherein the at least one cover layer is thermally and / or mechanically bonded, preferably pressed, to the molding layer,
By thermal interconnection is meant, inter alia, that the mold layer and / or the at least one cover layer is heated by heat input from an external heat source (eg, heated press device) above the respective melting point whereby the mold layer and cover layer fuse to one another, for example by penetrating the mold layer into the cover layer this encloses. The mold layer and cover layer are thus joined together, and after hardening of the fused molding layer and / or cover layer, a firm bond is produced.
By mechanical connection is meant, inter alia, interlocking or force-locking connections made by means of appropriate connecting devices, e.g. Rivets or pins can be made. The connecting devices may in this case be arranged on the molding layer and / or the at least one cover layer, preferably in one piece. The connecting devices may also be separate connecting means with which the molding layer and covering layer are joined together, e.g. by being compressed in a pressing device.
Thus, a proposed film comprises at least one cover layer and one shaping shaping layer, wherein both the at least one covering layer and the shaping shaping layer are bioresorbable in the body.
The at least one cover layer, which may for example be formed as a membrane, may serve to cover and seal a bone defect site in order to prevent the penetration of soft tissue into the bone defect site. It may also be flexible and preferably elastic to allow good coverage and sealing of the bone defect site. In order to further improve the application of the film and the sealing of the bone defect site, the at least one cover layer may also be formed so that it adheres to a gum surrounding the bone defect site.
The forming mold layer may be formed as a substantially dimensionally stable layer which is capable of being deformed under both thermal and mechanical and / or chemical influence and in turn has sufficient dimensional stability after this deformation to maintain the cavity for bone growth for the required period of time. In particular, the mold layer may serve to mold the film to a bone defect site.
Through the shaping shaping layer, a cavity can be formed between bone defect site and foil so that bone growth can take place in this cavity. For favorable bone regeneration, the lumen can also contain bone replacement materials and / or carriers for drugs, growth factors, and / or other healing and bone-forming and protective substances. The cavity may be maintained by the space-forming and space-occupying mold layer until the cavity is filled by the regrowing bone material.
The proposed method enables the preparation of a pre-bonded multilayer film comprising a forming mold layer and at least one cover layer.
As a result of both the at least one cover layer and the molding layer being bioabsorbable, the film or membrane as a whole can be completely degraded in the body (e.g., by hydrolysis). Thus, performing another operation for removing the film is eliminated. In other words, only an operation for attaching the film is required here.
The provision of the at least one cover layer with the shaping mold layer as an already pre-bonded multilayer film results in a film which is easy to handle and covers a bone defect which combines the room-forming properties of the mold layer with the sealing properties of the cover layer and which, moreover, is substantially completely absorbed in the body.
The multilayer film produced by the proposed method can be widely used as a surgical and / or therapeutic film. Thus, in addition to the specific application in the field of jaw augmentation, a proposed multi-layered film can also be used in ophthalmic fractures, fractures of the skull, and generally in the fields of neurosurgery and traumatology, and generally for surgical and / or therapeutic purposes.
According to a preferred embodiment of the invention, it can be provided that, for the thermal connection of the at least one cover layer to the mold view, at least the molding layer is heated. Preferably, the mold layer may be heated to a temperature in the range of about 50 ° C to about 70 ° C, preferably to a temperature of about 60 ° C. By thermoforming the mold layer, it can be thermally bonded to the at least one cover layer by external heat by, for example, fusing the mold layer to the cover layer.
In a particularly preferred embodiment it can be provided that thorn-like projections are arranged on the mold layer, wherein the projections are pressed into the at least one cover layer and / or through which at least one cover layer is inserted by the application of the at least one cover layer to the mold layer. Preferably, it can be provided that the projections are integrally formed on the mold layer. By providing projections on the mold layer, improved mechanical bonding of the mold layer to the at least one cover layer can be achieved. If the mold layer and also its protrusions are thermoformable, the protrusions can be thermally thermally bonded to the at least one cover layer by external heat application, by applying heat For example, projections in the cover layer are melted down. For example, when the projections protrude through the at least one cover layer, the ends of the projections may, in the mechanical and / or thermal bonding of the molding layer with the at least one cover layer, deform mushroom-like, thus effecting improved bonding of the layers.
In another preferred embodiment, it may be provided that substantially completely bioresorbable connection devices, preferably rivets or pins, are passed through the mold layer and the at least one cover layer. Preferably, the connection devices are also thermoformable. Again, upon compression of the mold layer with the at least one cover layer, preferably externally under heat, the ends of the connection devices may be rivet-shaped, thereby providing improved bonding of the layers, for example in the form of a nonwoven connection.
Preferably, it can be provided that the at least one cover layer is pressed with the mold layer in a pressing device. In this case it can be provided that, during the pressing, at least one surface of the pressing device facing the film is heated, preferably to a temperature in the range from about 50 ° C. to about 70 ° C., particularly preferably to a temperature of about 60 ° C.
Protection is also desired for a multilayer film having the features of claim 9. Advantageous embodiments of the multilayer film are given in the dependent claims.
According to the invention, it is thus provided that the at least one cover layer is thermally and / or mechanically connected to a thermoformable and substantially completely bioresorbable molding layer.
In a particularly preferred embodiment it can be provided that thorn-like projections are arranged on the mold layer, wherein preferably the protrusions are integrally formed on the mold layer.
According to a preferred embodiment it can be provided that the mold layer and the at least one cover layer are substantially completely bioresorbable at different times. Thus, for example, by making the mold layer and the at least one cover layer, it is possible to achieve that the mold layer absorbs faster than the at least one cover layer. In general, the bioresorbability of the mold layer and the at least one cover layer have great freedom in the design of the film with respect to its bioresorbability.
It may be provided that the film is substantially completely bioabsorbable over a period of about 3 to 12 months, preferably about 4 to 6 months. This is the period of time within which bone reconstruction usually takes place.
To enable good conformance to the bone defect site and stable voiding between the film and the bone defect site, it may be provided that the molding layer is stiffer than the at least one covering layer. The higher stiffness of the shaping layer serves to form a cavity for the bone structure and to maintain this cavity also for the period required for the bone regeneration. By virtue of the rigidity of the at least one cover layer, which is lower than that of the mold layer, good coverage and sealing of the bone defect site can again be achieved.
It can preferably be provided that the mold layer, optionally together with the at least one cover layer, is formed both thermally and mechanically and / or chemically deformable. In particular, the mold layer can be formed as a substantially dimensionally stable layer which can be deformed under both thermal and mechanical or chemical influence and in turn has sufficient shape stability after this deformation to maintain the cavity for bone growth for the required period of time. The at least one cover layer may be flexible and preferably elastic to allow good coverage and sealing of the bone defect site.
A mechanical deformation can be done for example by Veibiegen with a pair of pliers. This is a suitable method of molding, especially for relatively thin mold layers (e.g., in the range of about 0.10 mm to about 0.5 mm). For thicker mold layers (e.g., thicker than about 0.5 mm), thermal deformation of a mold layer for molding may be desirable. A corresponding thermal deformation can be achieved, for example, by means of a thermostatic hot tip or surface, over heated prefabricated models or in a hot water bath with sterile saline solution. For a good bioresorbability of the proposed film it can be provided that the at least one cover layer at least partially, preferably essentially completely, consists of a bioresorbable collagen material. It may be provided that the bioresorbable collagen material contains type I collagen and / or type III collagen material. Collagen includes. For example, the collagen material may be derived from bovine Achilles tendons. In addition, for a good bioresorbability of the proposed film, it may be provided that the molding layer consists at least partially, preferably substantially completely, of a bioresoibable polymer material. The bioresorbable polymer material may also be a co-polymer material.
A particular embodiment provides that the bioresorbable polymer material comprises lactic acid, preferably L-lactic acid, and / or its derivatives. It is advantageous if the proportion of lactic acid in the bioresorbable polymer material is at least 70%, preferably about 80% to 95%, particularly preferably substantially 82%.
In addition, it may be provided that the bioresorbable polymer material comprises glycolic acid. It is advantageous if the proportion of glycolic acid in the bioabsorbable polymer material is at most 30%, preferably about 15% to 20%, particularly preferably substantially about 18%. Depending on the composition of the mold layer, it may be achieved that the mold layer is substantially dimensionally stable and yet substantially completely bioresorbable.
In a further preferred embodiment it can be provided that the mold layer and the at least one cover layer have different surface expansions. It can be provided that the mold layer occupies a smaller surface area than the at least one cover layer. If the at least one covering layer covers the shaping layer due to its smaller surface area, a particularly good covering and thus also sealing of the bone defect site can be achieved.
It can preferably be provided that the at least one cover layer and / or the mold layer is or are formed essentially continuous over the entire surface. A favorable for the Anformung to the bone defect site contour of the film can be achieved, for example, by appropriately cutting the film.
However, it is particularly favorable if the shaping layer has a shaping structure for molding on the bone defect site. It can be provided that the shape structure at least partially a convex and / or concave curved edge and / or at least partially has a convex and / or konkav curved shape. In other words, the shape structure may, for example, have planar - convexly and / or concavely curved - projections and thus have a convex and / or concave curved edge. Alternatively or additionally, the shape structure as a whole may also have a correspondingly convex and / or concave curved shape.
It is particularly advantageous if the mold structure has at least one strut-shaped attachment element. The strut-shaped or lobe-shaped attachment elements can thereby be shaped like a hoop over the bone defect site and allow an arbitrary cavity shape.
Particularly advantageous is that embodiment of the invention in which the mold structure is formed substantially lattice-shaped. The lattice-shaped mold structure in this case forms a reinforcing grid which allows the formation of a variety of arbitrary cavity shapes.
It can also be provided that the mold 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 hardening gel is applied to the at least one cover layer, it is favorable if the mold structure can only be achieved by applying more liquid or gel in the region of the mold structure. In this case, for example, the mold layer may have different thicknesses.
A particular embodiment provides that the film has a carrier layer for at least one substance to be arranged or arranged thereon. The substances to be arranged or disposed on the carrier layer may be drugs, growth factors and / or other healing and bone-forming and protective substances. The backing layer may preferably be disposed on a side of the film facing the bone defect site and at least partially, preferably substantially completely, made of a bioresorbable collagen material.
It can also be provided that corresponding substances are applied directly to the mold layer and / or the at least one cover layer. It can also be provided that the side or surface of the film to be turned towards a bone defect site itself serves as a support for the substances described above, in that, for example, this side or surface of the film has a corresponding roughness.
The proposed film or membrane may also be pre-cut and / or preformed depending on the application. For example, a desired cut and / or a desired 3-D deformation of the film may be carried out according to a data-processing-based planning.
Further details and advantages of the present invention will be explained with reference to the following description of the figures. Showing:
1 shows a schematic pressing device for producing a proposed multilayer film,
FIG. 2 shows a multilayer film produced according to the proposed method, in a schematic side view, FIG.
3a-3c an embodiment of the production of a proposed multilayer film with a mold layer with molded, dome-like projections,
4a-4c another embodiment of the preparation of a proposed multilayer film with a mold layer mitangeformten, dome-like projections,
5a-5d an embodiment of the production of a proposed multilayer film using rivet-type connecting devices,
6 shows an embodiment of the proposed multilayer film in an exploded perspective view,
7 is a side view of the proposed multilayer film according to FIG. 6;
8 is a plan view of another embodiment of the proposed multilayer film;
9 is a form of layer with molded, thorn-like projections inperspective view,
10 is a form layer with arranged thereon pin-shaped projections inperspective view,
11 shows an embodiment of the proposed multilayer film in an exploded perspective view,
FIG. 12 shows the film according to FIG. 11 after the cover layers have been applied to the mold layer, FIG.
13 shows the film according to FIG. 12 after pressing the cover layers with the molding layer, FIG.
14 shows the finished film according to FIG. 13 in a side view, FIG.
FIG. 15 shows a cover layer with recesses for projections of the molding layer, FIG. 16 shows another covering layer with recesses for protrusions of the molding layer,
Fig. 17 is a plan view of another embodiment of the proposed multilayer film Fig. 18-21 are plan views of various other embodiments of the proposed multilayer film,
22-29 several embodiments of the proposed multilayer film in perspective exploded views,
FIG. 30 shows a proposed multilayer film disposed on a bone defect of a jawbone. FIG.
FIG. 31 shows a proposed multilayer film arranged at a bone defect site of a jawbone with an implant, FIG.
Fig. 32 shows a proposed multilayer film arranged on a
Bone defect site of a jawbone with implant, washer and posts,
Fig. 33 shows a proposed multilayer film clamped in a groove of a washer,
Fig. 34 shows a proposed multilayer film clamped in a groove of a washer and placed at a bone defect site of a jawbone with implant and post,
Fig. 35 shows a proposed multilayer film disposed at a bone defect site around a natural tooth and Fig. Figure 36 shows a proposed multilayer film arranged at a bone defect site around a natural tooth in a sectional view.
Fig. 1 shows schematically a pressing device 22 for producing a proposed multilayer film 1 in a side view. The pressing device 22 has two pressing jaws 26, 27 with pressing surfaces 23, 24, between which a covering layer 4 and a shaping layer 3 are arranged.
Both cover layer 4 and mold layer 3 are bioresorbable. The mold layer 3 is furthermore thermally deformable, that is to say that the mold layer 3 can be deformed from outside under the action of heat.
The pressing device 22 is equipped with at least one heating device 25, which enables the surfaces 23 and 24 of the pressing device 22 facing the film 1 to be heated, as a result of which the film 1 or at least the thermoformable shaping layer 3 of the film 1 can subsequently be heated. By moving pressing jaws 26, 27 of the pressing device 22 in the arrowing direction, the covering layer 4 applied to the shaping layer 3 is thermally and / or mechanically bonded, preferably pressed, by the at least one heating device 25, the surfaces 23, 24 of the pressing jaws 26, 27 of the Pressing device 22 are heated to the same temperature or at different temperatures.
FIG. 2 shows the film 1 according to FIG. 1 after being joined by the pressing device 22. The cover layer 4 and the molding layer 3 are firmly connected to one another and form a bonded multilayer film 1.
3a to 3c show the production of a further proposed multilayer film 1. Fig. 3a shows two layers of the film 1 to be produced, namely a cover layer 4 and a mold layer 3. The mold layer 3 has dome-like projections 20, which in this example in one piece are formed on the mold layer 3. When or by the application of the cover layer 4 to the mold layer 3, the projections 20 drill into the cover layer 4, but do not protrude through the cover layer 4 in this example. 3b shows the arrangement of cover layer 4 and mold layer 3 after the covering layer 4 has been applied to the molding layer 3. In a pressing device 22 with heating device 25, a mechanical and thermal bonding of the cover layer 4 to the molding layer 3 takes place by pressing the pressing jaws 26, 27 of the pressing device 22 be moved towards each other in the arrow direction and thereby compress the cover layer 4 with the mold layer 3. By heating a face 23 of the pressing jaw 27 and / or a face 24 of the pressing jaw 26 by means of heating means 25, during this pressing, the forming layer 3 can be heated, for example to a temperature in the range of about 50 ° C to about 70 ° C. By this external heat application it can melting of the projections 20, whereby the projections 20 of the mold layer 3 with the cover layer 4 can melt, as shown in Fig. 3c. The regions A, B marked in FIGS. 3 b and 3 c each show a ruptured region of the film 1 in order to illustrate how the projections 20 penetrate into the cover layer 4 within the film 1 and fuse with the cover layer 4. In addition to an equally possible melting of the mold layer 3 to the cover layer 4, the projections 20 fused into the cover layer 4 allow a firm, dowel-like connection.
4a to 4c show another example of a method of producing a proposed film 1. Similar to Fig. 3a, here too, the mold layer 3 has protrusions 20 which, in this example, are so long as to pass through the cover layer 4 to the mold layer 3 the cover layer 4 protrude, as shown in Fig. 4b. By pressing the cover layer 4 with the mold layer 3 by means of the pressing device 22, the tips of the projections 20 protruding through the cover layer 4 are mushroom-shaped so that a firmly bonded multilayer film 1 is formed, as shown in Fig. 4c. In addition to connecting the abutting surfaces of cover layer 4 and mold layer 3, the heads 28 of protrusions 20 formed by thermal compression provide for positive engagement of cover layer 4 with mold layer 3.
5a to 5d shows a further example of the production of a proposed multilayer film 1. In this case, according to FIG. 5a, in addition to a cover layer 4 and a mold layer 3, a plurality of connecting devices 21 in the form of rivets or pins are used. FIG. 5 b shows the cover layer 4 applied to the mold layer 3 and a plurality of the connection devices 21 which have been inserted through the mold layer 3 and cover layer 4. The connecting devices 21 are provided in this example at one end with a head, the heads abut the mold layer 3 and the free ends of the connecting devices 21 protrude through the mold layer 3 and cover layer 4 and the cover layer 4 protrude. According to FIG. 5 c, the arrangement of FIG. 5 b is introduced into a pressing device 22 and thermally pressed by means of pressing jaws 26, 27 of the pressing device 22. FIG. 5d shows the finished multilayer film 1. In this case, it can be seen that the free ends of the connecting devices 21 were deformed by the pressing in such a way that heads 28 formed, which rest against the cover layer 4. This results in a positive-locking connection in the manner of a riveted joint.
Figure 6 shows an exploded perspective view of a pre-bonded multilayer film 1 according to the invention. The film 1 comprises a forming layer 3, as well as two covering layers 4a and 4b. The mold layer 3 is stiffer than the cover layers 4a and 4b and has a mold structure 5. The mold structure 5 comprises a plurality of strut-shaped molding elements 7, which serve to form the film 1 via a bone defect 2 (not shown here), the film 1 fitting well through the molding elements 7 to a remaining bone 11 of the bone defect 2 (see eg FIG. 30). can be molded. The mold structure 5 is generally substantially lattice-shaped and thus allows the formation of any surface shapes of the film 1, so that in connection with a bone defect 2 any cavity forms between film 1 and bone defect site 2 can be formed.
The mold layer 3 and the cover layers 4a and 4b each consist of a bioresorbable material, so that the film 1 as a whole is completely bioresorbable in the body. By providing two cover layers 4a and 4b between which the mold layer 3 is embedded, in particular, the resorption speed and mechanical strength of the mold layer 3 can be controlled.
The cover layers 4a and 4b can be, for example, bioresorbable collagen membranes which, on the one hand, can cover a bone defect 2 well by their softness and on the other hand can bond well to a gum 13 surrounding the bone defect 2 so that a good sealing of the bone defect 2 results.
For example, the mold layer 3 may be made of a bioabsorbable polymeric material or copolymer material. In particular, the mold layer 3 may comprise, for example, about 82% L-lactic acid and about 18% glycolic acid. Such a choice of material results in a substantially dimensionally stable mold layer 3, which may be formed both thermally and mechanically and / or chemically deformable for forming at a bone defect site 2, wherein the mold layer 3 is substantially dimensionally stable again after such deformation. Due to the rigidity and dimensional stability of the mold layer 3, a cavity for bone regeneration can thus be created between the film 1 and a bone defect 2, and also held for the period of bone regeneration.
FIG. 7 shows a side view of the joined multilayer film 1 according to FIG. 6.
FIG. 8 shows a plan view of a further variant of the proposed film 1, which in this example has two layers and comprises a mold layer 3 and a cover layer 4. Both the mold layer 3 and the cover layer 4 are substantially flat. The film 1 can be cut to any desired shape to allow a good Anformung to a bone defect site 2, depending on the application
Fig. 9 shows an example of a mold layer 3 with protrusions 20 formed thereon, and Fig. 10 shows another example of a mold layer 3, in which example pin-shaped protrusions 20 are disposed on both the upper and lower surfaces of the mold layer 3.
11 shows an exploded perspective view of a proposed multilayer film 1 comprising a mold layer 3 according to FIG. 10 and two cover layers 4a and 4b.
FIG. 12 shows the film 1 of FIG. 11 after the application of the cover layers 4a and 4b to the molding layer 3. It can be seen that the projections 20 of the molding layer 3d project through the cover layers 4a and 4b.
FIG. 13 shows the film 1 of FIG. 12 after the covering layers 4a and 4b have been coated with the shaping layer 3. By the spraying, which can be effected mechanically and / or thermally, a firmly bonded multilayer film 1 was produced. The protrusions 20 of the mold layer 3 projecting beyond the cover layers 4a, 4b were deformed by the swaging so that rivet-shaped heads 28 formed, which enable a positive connection of the mold layer 3 with the cover layers 4a, 4b.
FIG. 14 shows a side view of the produced film 1 according to FIG. 13.
FIG. 15 shows a cover layer 4, which is particularly suitable for connection to a mold layer 3 according to FIG. 9. This cover layer 4 has recesses 29 in the form of holes, which correspond to the projections 20 of the mold layer 3, so that a precise application of the cover layer 4 to the mold layer 3 is made possible.
FIG. 16 shows a further example of a cover layer 4, which in this case is provided with corresponding recesses 29 over the entire surface, so that this cover layer 4 can be placed anywhere on projections 20 of the molding layer 3.
FIG. 17 shows a further example of a proposed film 1 in a plan view. The cover layer 4 is provided in this example with a pattern of recesses 29, through which protuberances 20 of a molding layer 3 -covered in this example by the cover layer 4-protrude Ends of the projections 20 when thermally and / or mechanically bonding the cover layer 4 with the mold layer 3 to heads 28 deformed.
FIG. 18 and FIG. 19 show two further embodiments of a proposed two-layer film 1 with different outer contours of the cover layer 4 and differently shaped mold structures 5 of the mold layer 3.
Figure 20 and Figure 21 show further examples of proposed films 1, wherein in the examples shown here, the mold layer 3 was applied in each case as a gel on the cover layer 4 and subsequently cured. The mold layers 3 shown here each comprise a mold structure 5 which has been achieved, for example, by providing more gel in the regions of the mold structure 5 such that the mold layers 3 have different layer thicknesses. In the region of a mold structure 5, a mold layer 3 has a layer thickness which is stronger in each case than in the other regions of the mold layer 3.
FIGS. 22 to 29 show further exemplary embodiments of a proposed film 1 in each case in an exploded perspective view. The side 9 of a film 1 pointing downwards in the figures is the side 9 of the film 1 to be used for a bone defect.
The examples of FIG. 22 and FIG. 23 are constructed in two layers and each comprise a mold layer 3 and a cover layer 4, the mold layer 3 occupying a smaller surface area than the cover layer 4. The examples of
FIG. 24 and FIG. 25 are constructed in three layers and each comprise, in addition to a mold layer 3 and a cover layer 4, a carrier layer 8 on which substances such as, for example, medicaments, growth factors and / or other healing and bone-forming and protective substances may be applied.
The examples of Figures 26 to 29 each have a mold layer 3 and two cover layers 4a and 4b, respectively, with the mold layer 3 occupying a smaller roughness than the cover layers 4a and 4b. The examples of Figures 27 to 29 each additionally include a carrier layer 8 which may be populated with corresponding substances (as described above for Figure 24 and Figure 25).
FIG. 30 shows a sectional view of a jawbone 11 with a bone defect site 2. In order to allow bone formation at the bone defect site 2, a pre-multilayered foil 1 is correspondingly formed over the bone defect site 2 and anchored to the jawbone 11 by means of appropriate fastening devices 12. The attachment devices 12 may be, for example, bioresorbable nails. Bone replacement materials and / or carriers for medicaments, growth factors, and / or other healing and bone formation and development of a periodontal ligament may include unnatural teeth-enhancing and protective substances in the forming cavity 10 between film 1 and bone defect 2 and jawbone 11, respectively, to promote bone regeneration. After attaching the film 1, the gum 13, which has been removed or folded back, is covered again over the film 1 and sewn accordingly. Due to the bioresorbability of the film 1 and the fastening devices 12, no further operation is required to remove the film 1 and / or the fastening devices 12 again after the bone has been completed.
FIG. 31 shows a bone defect 2 similar to that of FIG. 30, which is covered with a proposed foil 1. In this example, an implant 14 was used in the still existing jaw bone 11, the free end is equipped with a screw 15. In this case, for easier accessibility to the implant 14 or its screw 15, it may be provided that the foil 1 is already provided with a pre-punched hole through which the screw 15 can protrude.
FIG. 32 shows another example of a bone defect 2 covered with a proposed foil 1. In the jawbone 11 an implant 14 is already used, at the free end of a post 16 is arranged. The post 16 projects through both the film 1 and the gum 13 to facilitate further tooth construction. An additional washer 18 is disposed between post 16 and foil 11st. By means of this washer 18, a seal of the film 1 can be achieved in that region of the film 1 through which the post 16 penetrates through the film 1 (penetrating region). This is important on the one hand to seal the film 1 against the oral cavity and thus the To inhibit the development of inflammation. On the other hand, it can also be achieved that the film 1 absorbs more slowly in precisely this sensitive penetration area and thus better protects this area. The washer 18 may consist of titanium and project radially beyond the implant 14. The shape of the washer 18 may be, for example, round or oval. The washer 18 may also be cut to allow optimum closure of the penetration area through the film 1 or to stabilize the sensitive defective area around the implant 14, as the case may be. In this case, the washer 18 can also be made so that the film 1 can be clamped in a groove of the washer 18 as required and pressed to achieve stabilization.
Figure 33 shows a film 1 pinched and squashed in a groove of a washer 18 and Figure 34 shows the arrangement of this film 1 at a bone defect site 2. In the example shown, the top end of the implant 14 (implant head) does not jut the jawbone 11 but is located below the bone level. Depending on how deep the upper end of the implant 14 is in the jawbone 11 or how great the level difference between the implant head and the bone level is, it can be achieved by varying the height
Inserts 19 a balance can be created so that the film 1 or washer18 can be fixed without cratering,
FIG. 35 shows an example of a bone defect 2 around a natural tooth 17 covered with a proposed foil 1. In this example, the application of the proposed film 1 for covering a periodontal cone defect site 2 covered by the film 1 sections of the jaw bone 11 and the tooth 17 are shown in broken lines.
Figure 36 is a sectional view of a jawbone 11 having a bone defect site 2 around a natural tooth 17. To permit bone augmentation and / or abutment structure development at the bone defect site 2, a proposed pre-bonded multilayer film 1 is molded over the bone defect site 2 and tooth 17, respectively Fasteners 12 anchored to the jawbone 11. Both attachment devices 12 may be, for example, bioresorbable nails. Bone replacement materials and / or carriers for medicaments, growth factors, and / or other healing and bone formation and development of a periodontal ligament may include unnatural teeth-enhancing and protective substances in the forming cavity 10 between film 1 and bone defect 2 and jawbone 11, respectively, to promote bone regeneration. After attachment of the film 1, the previously removed or folded back gum 13 is covered again over the film 1 and sewn accordingly. Due to the bioresorbability of the film 1 and the fastening devices 12, no further operation is required to remove the film 1 and / or the fastening devices 12 again after the bone has been completed.

权利要求:
Claims (29)
[1]
Claims 1. A method for producing a multilayer film (1), in particular for covering a bone defect (2), the film (1) comprising at least one substantially completely bioresorbable covering layer (4,4a, 4b), characterized in that the at least one Cover layer (4,4a, 4b) is applied to a thermoformable and substantially completely bioresorbable mold layer (3), wherein the at least one cover layer (4,4a, 4b) with the mold layer (3) thermally and / or mechanically bonded, preferably pressed, becomes.
[2]
2. The method according to claim 1, characterized in that for the thermal connection of the at least one cover layer (4,4a, 4b) with the mold layer (3) at least the mold layer (3) is heated.
[3]
A method according to claim 2, characterized in that the mold layer (3) is heated to a temperature in the range of about 50 ° C to about 70 ° C, preferably to a temperature of about 60 ° C.
[4]
4. Method according to one of claims 1 to 3, characterized in that dome-like projections (20) are arranged on the molding layer (3), wherein by the application of the at least one cover layer (4, 4a, 4b) to the molding layer (3) the projections ( 20) are pressed into the at least one cover layer (4, 4a, 4b) and / or through which at least one cover layer (4, 4a, 4b) is inserted.
[5]
5. The method according to claim 4, characterized in that the projections (20) are integrally formed on the mold layer (3).
[6]
A method according to any one of claims 1 to 5, characterized in that substantially completely bioresorbable sealing devices (21), preferably rivets or pins, are inserted through the forming layer (3) and at least one covering layer (4,4a, 4b).
[7]
A method according to any one of claims 1 to 6, characterized in that the at least one covering layer (4, 4a, 4b) is pressed with the forming layer (3) in a pressing device (22).
[8]
A method according to claim 7, characterized in that at least one surface (23,24) of the pressing device (22) facing the film (1) is heated during the pressing, preferably to a temperature in the range from about 50 ° C to about 70 ° C, more preferably to a temperature of about 80eC.
[9]
9. A multilayer film (1) for covering a bone defect site (2), in particular produced by a method according to one of claims 1 to 8, wherein the film (1) comprises at least one substantially completely bioabsorbable covering layer (4, 4a, 4b) in that the at least one covering layer (4, 4a, 4b) is connected thermally and / or mechanically to a thermoformable and essentially completely bioresorbable shaping layer (3).
[10]
A multilayer film (1) according to claim 9, characterized in that dome-like protrusions (20) are arranged on the mold layer (3), and preferably the protrusions (20) are formed integrally with the mold layer (3).
[11]
11. Multilayer film (1) according to claim 9 or 10, characterized in that the mold layer (3) and the at least one cover layer (4, 4a, 4b) are substantially completely absorbable at different time intervals.
[12]
A multilayer film (1) according to any one of claims 9 to 11, characterized in that the film (1) is substantially completely absorbable over a period of time of about 3 to 12 months, preferably about 4 to 6 months.
[13]
13. A multilayer film (1) according to any one of claims 9 to 12, characterized in that the mold layer (3) is stiffer than the at least one cover layer (4,4a, 4b) is formed.
[14]
14. Multilayer film (1) according to any one of claims 9 to 13, characterized in that the mold layer (3), optionally together with the at least one cover layer (4,4a, 4b), both thermally and mechanically and / or chemically deformable.
[15]
15. Multilayer film (1) according to any one of claims 9 to 14, characterized in that the at least one cover layer (4, 4a, 4b) at least partially, preferably substantially completely, consists of a bioresorbable collagen material.
[16]
16. A multilayer film according to claim 15, characterized in that the bioabsorbable collagen material comprises type I collagen and / or type III collagen.
[17]
A multilayer film (1) according to any one of claims 9 to 16, characterized in that the forming layer (3) consists at least partially, preferably substantially completely, of a bioresorbable polymer material.
[18]
18. The multilayer film (1) according to claim 17, characterized in that the bioabsorbable polymer material comprises lactic acid, preferably L-lactic acid, and / or derivatives thereof.
[19]
Multilayer film (1) according to claim 17, characterized in that the proportion of lactic acid in the bioabsorbable polymer material is at least 70%, preferably about 80% to 95%, more preferably substantially about 82%.
[20]
20. A multilayer film (1) according to any one of claims 17 to 19, characterized in that the bioresorbable polymer material comprises glycolic acid.
[21]
21. The multilayer film (1) according to claim 20, characterized in that the proportion of glycolic acid in the bioabsorbable polymer material is at most 30%, preferably about 15% to 20%, particularly preferably substantially about 18%.
[22]
22. Multilayer film (1) according to any one of claims 9 to 21, characterized in that the mold layer (3) and the at least one cover layer (4,4a, 4b) have different surface expansions.
[23]
A multilayer film (1) according to claim 22, characterized in that the forming layer (3) occupies a smaller surface area than the at least one covering layer (4, 4a, 4b).
[24]
24. Multilayer film (1) according to any one of claims 9 to 23, characterized in that the at least one cover layer (4,4a, 4b) and / or the Formschicht (3) is formed substantially continuously flat.
[25]
A multilayer film (1) according to any one of claims 9 to 24, characterized in that the molding layer (3) has a molding structure (5) for molding to the bone defect site (2).
[26]
26. Multilayer film (1) according to claim 25, characterized in that the mold structure (5) at least in sections has a convexly and / or concavely curved edge (6) and / or at least partially has a convexly and / or concavely curved shape.
[27]
27. Multilayer film (1) according to claim 25 or 26, characterized in that the mold structure (5) has at least one strippenförmiges Anformelement (7).
[28]
28. A multilayer film (1) according to any one of claims 25 to 27, characterized in that the mold structure (5) is formed substantially lattice-shaped. 2Θ. Multilayer film (1) according to one of claims 25 to 28, characterized in that the mold structure (5) is formed by at least one reinforcement of the mold layer (3).
[29]
30. Multilayer film according to one of claims 9 to 29, characterized in that the film (1) has a carrier layer (8) for at least one substance to be arranged or arranged thereon.

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同族专利:

公开号 | 公开日

DK3177232T3|2019-12-09|

AT516116B1|2016-05-15|

CN106659568B|2019-06-28|

EP3177232B1|2019-09-04|

PL3177232T3|2020-03-31|

ES2760013T3|2020-05-12|

CN106659568A|2017-05-10|

US20170143492A1|2017-05-25|

WO2016019404A1|2016-02-11|

US10624747B2|2020-04-21|

EP3177232A1|2017-06-14|

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法律状态:

优先权:

申请号 | 申请日 | 专利标题

ATA622/2014A|AT516116B1|2014-08-05|2014-08-05|Method for producing a multilayer film|ATA622/2014A| AT516116B1|2014-08-05|2014-08-05|Method for producing a multilayer film|

CN201580042099.4A| CN106659568B|2014-08-05|2015-07-15|Method for manufacturing multilayer film|

DK15747353T| DK3177232T3|2014-08-05|2015-07-15|PROCEDURE FOR MANUFACTURING A MULTILAYER FILM|

ES15747353T| ES2760013T3|2014-08-05|2015-07-15|Method for making a multilayer film|

PCT/AT2015/000098| WO2016019404A1|2014-08-05|2015-07-15|Method for producing a multilayer film|

PL15747353T| PL3177232T3|2014-08-05|2015-07-15|Method for producing a multilayer film|

EP15747353.9A| EP3177232B1|2014-08-05|2015-07-15|Method for producing a multilayer film|

US15/423,969| US10624747B2|2014-08-05|2017-02-03|Method for producing a multilayer film|

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