Implants for bone treatment

Abstract

The present invention relates to an implant (1) for the treatment of bones, in particular for covering defects or drill holes or for the reconstruction of bone defects or malformations, which comprises at least one framework (2) and at least one adaptation zone (3), whereby the edge (4) of the implant is formed partially, rather than continuously, by the framework (2) located outside the adaptation zone (3).

Description

[Technical field]

[0001] The invention relates to an implant for bone repair having the features of the general title of the independent claim. [Background technology]

[0002] It is known that fractures of the skull, particularly in humans, can be treated with implants. The purpose of treatment with implants and implant placement is generally to restore and maintain the anatomically correct shape and position of the bone to be treated and the surrounding area, thus facilitating the healing process and maintaining the function of the affected part of the body after healing.

[0003] In the prior art, various implants are known which are adapted to specific parts of the body.

[0004] EP2030596 discloses implants for the treatment of orbital fractures. These include a planar mating area and a frame structure.

[0005] No. 5,139,497 discloses an orbital floor implant having a framework and a lattice.

[0006] US2007 / 0238069 discloses a cuttable and deformable mesh for the treatment of facial fractures. Summary of the Invention [Problem to be solved by the invention]

[0007] However, known implants have various drawbacks. For example, some implants are provided with a framework structure that is adapted to a particular bone area. However, this can make the placement of the implant difficult, especially since people's exact anatomy naturally varies. At the same time, however, it is desirable to adapt to the anatomy to some degree.

[0008] The object of the present invention is therefore to avoid the disadvantages of the prior art, in particular to provide an implant which, on the one hand, is adapted to the anatomical structure of the body part to be treated and at the same time allows a specific adaptation. [Means for solving the problem]

[0009] According to the present invention, these and other objects are achieved with an implant as claimed in the independent claims.

[0010] The implant according to the invention is particularly suitable for covering defects or drill holes or for reconstructing bone defects or malformations. The implant comprises at least one framework and a sheet-like adaptation area. The framework is arranged outside the adaptation area and partially forms the edge of the implant. However, the framework does not completely define the outer edge. This means that at least one area of ​​the outer edge is not restricted by the framework. This allows the framework of the implant to be adapted to the desired anatomical structure. At the same time, the adaptation area not restricted by the framework allows cutting or deformation, which allows a further adaptation to the anatomical structure.

[0011] The framework is to be understood as a region of the implant, in particular the edge region, which is designed by dimensioning and / or material selection and / or shaping the edge region, in particular preferably such that the minimum force required to plastically deform both the edge region and the conforming region is greater than the minimum force required to plastically deform the conforming region. This property is referred to herein and below as flexibility. Thus, a lower flexibility of a part means that a greater force needs to be applied to plastically deform the part. A higher flexibility of a part means that a smaller force is sufficient to plastically deform the part. Thus, the framework may be less flexible compared to the conforming region. Additionally or alternatively, the framework may also be a region of the implant that interrupts the periodicity of the lattice, in particular the edge region.

[0012] The implant according to the invention is particularly suitable for the treatment of the human frontal sinus and is shaped and dimensioned accordingly, however, it can of course also be used in other parts of the body, provided that the size and shape are suitable.

[0013] Particularly preferably, the implant is mirror symmetrical along a mirror plane. Preferably, the implant comprises at least two framework structures, both of which are located outside the fitting area and thus partially form the edge of the implant. The two framework structures do not continuously delimit the outer edge of the implant. As a result, at least two areas of the outer edge are not bounded by the framework structures. In particular, this allows for fitting to bones with two similar and / or symmetrical areas, but with a middle area that differs from person to person. For example, the two framework structures may be fitted to the area around the eyes and may have a fitting area to fit the nasal bone.

[0014] Preferably, the conforming area is continuous and has no internal framework. Preferably, the framework is dimensioned and positioned such that at least half of the outer edge is not bounded by the framework, where half of the outer edge means half the length of the outermost edge of the implant.

[0015] Preferably, the adaptive zone includes a lattice structure. The lattice structure is dimensioned so that it can be deformed by hand or with hand tools. In particular, the adaptive zone can be designed so that its flexibility is appropriately adapted.

[0016] In particular, for this purpose the compliant area may be made from or may include a material having a failure strain of at least 5%, preferably at least 10%, more preferably at least 15%.

[0017] Likewise, the conforming area can be at least partially dimensioned such that a force of at most 300N, preferably at most 150N, particularly preferably at most 50N is required to plastically deform the conforming area, in particular to obtain a force acting perpendicularly to the conforming area. For example, the conforming area can have wire- or rod-like elements with a second moment of area or material properties to achieve such a deformability. Depending on the material properties, the dimensions or second moment of area of ​​the rod-like elements can be different to achieve the same deflection with the same force. Similarly, it is conceivable to make the conforming area thick enough to bring about a plastic deformation at a maximum force, in particular the maximum force mentioned above. In particular, the conforming area can be at most 2 mm, preferably at most 1 mm, particularly preferably at most 0.6 mm thick. Particularly preferably, the conforming area has a thickness of 0.25 mm, 0.4 mm or 0.6 mm.

[0018] Preferably, the implant comprises a biocompatible material, in particular from the group of steels and / or other metals, ceramics and plastics for implants. Particularly preferably, the implant comprises titanium or a titanium alloy.

[0019] Preferably, the conforming section has a connection section that is sized to be cuttable using hand tools, allowing a surgeon to easily cut the conforming section to fit the patient's anatomy.

[0020] In particular, the connection section may be designed as described above with respect to the matching section. The matching zone preferably comprises a structure of holes with peripheral zones which are connected to one another via connection zones, in particular the connection zones can be designed as ribs connecting the peripheral zones of said holes at equal intervals along their circumference.

[0021] Preferably, the implant has a side length in the range of 10 mm to 200 mm. Alternatively, the side length may be in the range of 30 mm to 70 mm, or 25 mm to 50 mm. In particular, the implant may have an approximately square shape with rounded corner regions. Particularly preferably, the framework is arranged at two adjacent rounded corner regions.

[0022] Preferably, at least one framework structure is sized and positioned to allow attachment, particularly screwing, to the supraorbital rim.

[0023] For this purpose, the framework may have at least one, preferably two, regions whose shape, curvature and / or size substantially correspond to the supraorbital rim. For example, the framework may have a radius in this region that has a deviation of at most + / - 30%, preferably at most + / - 20%, particularly preferably at most + / - 10% with respect to the radius of the orbit. This region of the framework may also have a radius that substantially corresponds to the radius of the orbit (i.e. has a radius that is approximately equal). Particularly preferably, the radius of this region is substantially the same as the radius of the orbit. Furthermore, these regions may have at most a length equal to the diameter of the human orbit. For example, the length may be at most 80 mm, preferably at most 60 mm, particularly preferably at most 50 mm.

[0024] Preferably, the framework has an arc shape. In particular, the arc shape may have a radius of curvature between 10 mm and 200 mm, more preferably between 10 mm and 80 mm. The radius of curvature may vary along the area of ​​the framework. For example, the radius of curvature may increase continuously along the edge structure such that the framework forms a clothoid shape.

[0025] Particularly preferably, the implant has an intermediate region, which is arranged between two frameworks adapted to the orbital rim and which may have a greater flexibility than the two frameworks.

[0026] It can likewise be envisaged by this that the intermediate region in particular has a length which essentially corresponds to the medial distance between the two orbits of the human skull and / or the width of the human nose and / or the typical anatomical distance between the human lacrimal glands.Preferably, the connecting piece has a length of 0.5 cm to 4 cm, particularly preferably 1 cm to 2 cm.

[0027] Preferably, the implant has at least one mounting tab. Alternatively, the implant may also have at least two mounting tabs. In particular, the mounting tabs may be located at the edge of the implant or on the framework. Preferably, the mounting tabs also have screw holes. This allows the implant to be fixed in a particularly advantageous manner, for example screwed into the bone. Preferably, Installation The tabs extend in the same plane as the implant and away from the edge of the implant, particularly at an azimuth angle of 70° to 95° relative to the edge. Installation If the edge of the implant is not straight where the tab is located, the azimuth angle regulation is: Installation Tab and Installation The angle between the tangent of the edge of the implant at the point where the tabs are located should be understood as the angle between the tangent of the edge of the implant at the point where the tabs are located. Particularly preferably, the two mounting tabs extend away from the implant such that there is an acute angle between the mounting tabs opening away from the implant.

[0028] Additionally or alternatively, one or more of the mounting tabs may also be positioned such that they do not lie in the same plane as the implant, the edge of the implant, or the matching area of ​​the implant, and thus lie at an elevation angle relative to that plane. In particular, the mounting tabs may be angled away from at least the plane in which the edge of the implant and / or the framework lie.

[0029] It is understood that implants with a free shape that is not flat are also conceivable. In particular, the implant may have local bends between surface elements and / or may have the shape of a rotational or translational surface. In this case, the above mentioned planes refer to tangent planes to the surface of the implant at the location where the tab is attached. Thus, in particular for tabs that are not in the same plane as the tangent plane, the elevation angle between the tab and its projection on the tangent plane can be measured. The azimuth angle can be measured in the tangent plane between the tab and the tangent of the edge of the implant.

[0030] In particular, at least one mounting tab may be integrally connected to the frame structure. The implant may also have at least two mounting tabs integrally connected to the frame structure. If the implant also has at least two frame structures, each of the at least two mounting tabs is preferably integrally connected to one frame structure. However, it is also possible to integrally connect multiple mounting tabs to the same frame structure.

[0031] Alternatively, however, it is also possible to arrange one or more mounting tabs on the edge of the implant without connecting them to a frame structure. In particular, one or two mounting tabs can be arranged between two frame structures. This is particularly advantageous if at least one frame structure is dimensioned and positioned so that it can be attached to the supraorbital rim, in particular so that it can be fastened by a screw.

[0032] Preferably, the at least one mounting tab is adapted for attachment to the nasal bone. This adaptation can be achieved, inter alia, by size, shape, and positioning on the implant. If the implant has at least two mounting tabs, preferably the at least two mounting tabs are similarly adapted for attachment to the nasal bone.

[0033] In particular, the mounting tab may have a length substantially equal to the length of the human nasal bone. For example, the mounting tab may have a length of up to 3 cm, preferably up to 2 cm, particularly preferably up to 1.5 cm. The two mounting tabs may be arranged relative to each other such that their minimum distance corresponds to the width of the nasal bone. For example, said distance may be about 5 mm to 30 mm. Preferably, the mounting tabs are not arranged parallel to each other in this case. However, the mounting tabs may be arranged in a plane at an angle greater or less than 0°. Mounting tabs assembled around their own longitudinal axis are also conceivable.

[0034] If the implant has one or two regions adapted for attachment to the supraorbital rim, the attachment tabs may be arranged in particular in these regions. Preferably, one attachment tab is arranged in each of the regions adapted for attachment to the supraorbital rim. Particularly preferably, the attachment tabs arranged in the regions adapted for attachment to the supraorbital rim are opposite each other. In this case, the implant may in particular be mirror-symmetrical along a plane and / or axis substantially between the two attachment tabs and / or between the regions adapted for attachment to the supraorbital rim. However, non-mirror-symmetrical designs are also conceivable.

[0035] Preferably, the conforming area is integrally formed. Preferably, the entire implant is integrally formed.

[0036] Preferably, the implant is adapted to cover a defect or burr hole or to reconstruct a bone defect or malformation over a paranasal sinus.

[0037] Preferably, the compliant area is plastically deformable, in particular the compliant area may be dimensioned or adapted with a choice of material to allow for plastic deformation.

[0038] The invention will be explained in more detail below with reference to the accompanying figures and embodiments. [Brief description of the drawings]

[0039] [Figure 1] 1 shows an embodiment of an implant according to the present invention. [Diagram 2] 1 shows an alternative embodiment of an implant according to the present invention. [Diagram 3] 13A-13C show yet another alternative embodiment of an implant according to the present invention. [Figure 4] FIG. 13 is an enlarged view of the mating area. [Diagram 5] 1 shows an alternative embodiment of an implant according to the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0040] FIG. 1 shows an embodiment of an implant 1 according to the invention, adapted in shape and size to be implanted in the region of the human frontal sinus. The implant comprises two frame structures 2 and an adaptation area 3. The outer edge of the implant is represented by a dashed line 4, which should here be understood generally as the outermost boundary of the entire implant before any cutting. The two frame structures 2 partially form the outer edge 4 of the implant. In particular, the frame structures 2 here have an arcuate shape, the shape and dimensions of which are adapted to the human supraorbital rim. Furthermore, they comprise screw holes 10 suitable for receiving screws so that the implant 1 can be screwed into the bone. The implant further comprises two mounting tabs 8, each of which is integrally connected to one of the frame structures 2. In this case, the mounting tabs 8 are connected at the opposite ends of the frame structures 2 between the two frame structures and extend in the same plane as the implant and away from it at an angle of about 85°. The mounting tabs 8 thus correspond to the position of the nasal bone when the frame structure is attached to the supraorbital rim. Furthermore, the mounting tabs include screw holes 10a suitable for screwing said mounting tabs into the nasal bone. Between the two frame structures 2 and the mounting tabs there is an intermediate area 5a without a frame structure, which in its design corresponds to the remaining edge area 5b of the implant and is designed in particular to have a higher flexibility than the frame structures. The force required to cause a plastic deformation of the intermediate area 5a is therefore relatively small and can be applied by hand or by hand tools. In this case, the implant only includes a frame structure adapted to the area of ​​the supraorbital rim. Said frame structure can be attached to the nasal bone via the mounting tabs. The remaining part 5b of the outer edge 4 can be trimmed by the surgeon since it is not bounded by a frame structure. This makes it possible, for example, to adapt the implant to a smaller area of ​​the patient's anatomy. In addition, the adaptation area 3 is plastically deformable to provide further adaptation possibilities.

[0041] FIG. 2 shows an alternative embodiment of an implant 1 according to the invention. The embodiment shown here includes only one frame structure 2. The frame structure partially divides the outer edge 4 so that a part 5 of the outer edge is formed without the frame structure. The sheet-like adaptation area 3 has essentially the same design as shown in FIG. 1 and is therefore plastically deformable and has a flexibility that allows plastic deformation by hand or by hand tools. The frame structure 2 is here adapted in shape and dimensions to correspond to the supraorbital rim. The implant has two mounting tabs 8, both of which are integrally connected to the frame structure 2. The mounting tabs are dimensioned and arranged so that they can be attached to the nasal bone. In particular, a screw hole 10a that can be used for screwing into the nasal bone serves this purpose. The frame structure also includes a screw hole 10 that serves the same purpose. Here, the frame structure 2 is continuous without interruption between the two mounting tabs 8. The intermediate area 9 between the mounting tabs therefore forms part of the frame structure 2. This is particularly advantageous when support and stabilization in this area is necessary for the treatment and / or when the shape and dimensions of the implant are adapted to the anatomy so precisely that no further adaptation is necessary. However, despite this, the adaptation area 3 can of course be plastically deformed and / or cut to accommodate the particular anatomy.

[0042] FIG. 3 shows an alternative embodiment of an implant 1 according to the invention, with two frame structures 2 that partially form the outer edge 4 of the implant. As a result, the implant comprises two further areas 5a, 5b of the outer edge 4 that are not delimited by the frame structure. The sheet-like conformable area 3 is also designed here to allow plastic deformation and cutting to size. It is dimensioned and designed, for example by material selection and / or shape, in particular so that the plastic deformation and / or cutting can be carried out by hand or with hand tools. Suitable hand tools include, in particular, commercially available pliers and cutting instruments. The implant has an approximately square shape with radii and rounded corner areas, in which the frame structure is also arranged. As a result, the implant comprises an area 11a that is free of sharp points or frays, in particular due to the frame structure. The second area 11b is in this example the opposite area 11a, which is particularly suitable for being cut smaller by the operator, since there is no frame structure. Preferably, the cutting is carried out on the opposite side of the frame structure. However, the fitting area can of course be cut into any shape, especially between the two frameworks. This results in a smaller implant than one with only one framework. Due to the freedom of cutting, the implant is particularly suitable for use in cases where the freedom of use is important because the precise fitting of the implant before surgery is impossible or difficult. For example, this is typically the case when treating bones that vary widely in size and shape between individuals.

[0043] Alternatively, it would of course be conceivable to cut the implant within the framework. Thus, the framework does not need to be designed such that it cannot be cut to size. In general, however, in most common applications, it is advantageous to arrange the framework so that cutting to size is not necessary. In this way, the framework forms an area without sharp edges.

[0044] FIG. 4 shows in detail the geometry of the sheet-like conforming area 3 and the lattice part. The lattice comprises holes 6 and connecting areas 7 designed as ribs. The connecting areas connect the circumferential areas of the holes 6. In the embodiment shown here, each circumferential area of ​​the holes 6 is connected to four connecting areas 7. These are distributed evenly along the circumference of the hole, i.e. at intervals of about 90°. The connecting areas are further dimensioned so that they can be cut with hand tools. Here, the outer diameter of the holes is 3.1 mm. However, it is also conceivable to form holes with different outer diameters, in particular in the range of 2 mm to 5 mm, preferably in the range of 3.0 mm to 3.22 mm. The wire-like elements forming the ribs and the circumferential areas of the holes have a width of 0.6 mm, but may alternatively have different widths in the range of 0.1 mm to 3.0 mm, preferably in the range of 0.5 mm to 0.7 mm. The lattice areas are about 0.5 mm thick, but may have different thicknesses in the range of 0.1 mm to 2.0 mm, preferably in the range of 0.3 mm to 0.6 mm. It is particularly advantageous to design the lattice from metal or (absorbable) plastic. Thus, the variant shown here is made of titanium or a titanium alloy. This design makes it possible to cut the sheet-like conforming area to the desired size. However, of course, other dimensions and / or materials can also be used. The geometry of the lattice forming the sheet-like conforming area 3 shown here is particularly advantageous for use in implants due to the properties described here. However, of course, any other known lattice structure can also be used.

[0045] FIG. 5 shows an alternative embodiment of an implant according to the invention. It essentially corresponds to the embodiment shown in FIG. 3, but further comprises two mounting tabs 8. These are similar to the mounting tabs used, for example, in the embodiment shown in FIG. 1. However, in the embodiment shown here, the mounting tabs 8 are not connected to a frame structure. Instead, both mounting tabs 8 are directly connected to the edge region 5b of the implant 1 and are thus located in an area of ​​the implant with greater flexibility. This allows the implant 1 to be used particularly advantageously in complex anatomical structures, since the mounting tabs 8 can be fixed with a maximum degree of freedom. For this purpose, the mounting tabs 8 also have screw holes 10. Of course, it may also be possible to combine the arrangements of the mounting tabs 8 shown in FIG. 1 and FIG. 5. For this reason, the variant shown here may additionally or alternatively comprise further mounting tabs 8 in the area of ​​the frame structure. Similarly, the embodiment shown in FIG. 1 may comprise further mounting tabs that are not connected to the frame structure.

Claims

1. An implant (1) for the treatment of bones, in particular for covering defects or drill holes or for reconstructing bone defects or malformations, at least one frame structure (2), - at least one conforming area (3), in particular a sheet-like conforming area, The at least one frame structure (2) is arranged outside the conforming area (3), partially forming the edge (4) of the implant, said at least one frame structure (2) does not continuously delimit said outer edge (4) such that at least one region (5) of said outer edge (4) is not delimited by said frame structure; The at least one frame structure (2) has an arc shape with a radius of curvature of 1 cm to 20 cm; The implant, wherein the arc shape is concave curving toward the inside of the fitting area, and the at least one framework is sized and positioned for attachment to the supraorbital rim.

2. 2. The implant (1) according to claim 1, comprising at least two frame structures (2) which together are each arranged outside the fitting area (3) and partially form the edge (4) of the implant, and wherein the at least two frame structures (2) do not continuously delimit the outer edge (4) such that at least two areas (5a, 5b) of the outer edge are not delimited by the frame structures.

3. The implant (1) according to claim 1 or 2, wherein the conforming area (3) is continuous and has no internal framework (2).

4. An implant (1) according to any one of claims 1 to 3, wherein the framework is dimensioned and positioned such that at least half of the outer edge (4) is not continuously bounded by the framework (2).

5. 5. An implant (1) according to any one of claims 1 to 4, wherein the adaptation zone (3) comprises a lattice structure (6), in particular a flexible one, dimensioned so that it can be deformed by hand or with a hand tool.

6. The implant (1) according to any one of claims 1 to 5, wherein the implant (1) comprises a biocompatible material, preferably selected from the group consisting of implant steels, metals, ceramics, plastics, composite materials, particularly preferably titanium or titanium alloys.

7. The implant (1) according to any one of claims 1 to 6, wherein the adaptation section comprises a connection section (7) dimensioned to be cut by a hand tool.

8. The implant (1) according to any one of the preceding claims, wherein the implant has at least one side length in the range of 10 mm to 200 mm, preferably 30 mm to 70 mm, particularly preferably 25 mm to 50 mm.

9. The implant (1) according to any one of claims 1 to 8, wherein at least one framework is dimensioned and positioned to be screwed into the supraorbital rim.

10. The implant (1) according to claim 9, wherein said arc shape has a radius of curvature of between 1 cm and 8 cm.

11. 11. The implant (1) according to claim 9 or 10, wherein the implant has an intermediate area (5a) between two frameworks adapted to the supraorbital rim, the intermediate area being more flexible than the frameworks.

12. An implant (1) according to any one of the preceding claims, wherein the implant (1) comprises at least one mounting tab (8), preferably at least two mounting tabs (8).

13. The implant (1) according to claim 12, wherein the at least one mounting tab (8), preferably the at least two mounting tabs (8), are integrally connected to a frame structure (2), preferably to at least two frame structures (2).

14. The implant (1) according to claim 12 or 13, wherein the at least one mounting tab (8), preferably the at least two mounting tabs (8), are adapted for mounting to a nasal bone, in particular by the size, shape and positioning of the at least one mounting tab (8), preferably the at least two mounting tabs (8) on the implant (1).

15. The implant (1) according to any one of claims 1 to 14, wherein said implant is adapted to cover a defect or a drill hole or to reconstruct a bone defect or malformation in the paranasal sinus.

16. The implant (1) according to any one of the preceding claims, wherein the conforming area (3) is integrally formed.

17. The implant (1) according to any one of the preceding claims, wherein the entire implant (1) is formed in one piece.

18. The implant (1) according to any one of the preceding claims, wherein the conforming area (3) is plastically deformable.

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