阅读说明：本技术 一种用于附接到骨骼的表面上的骨植入物 (Bone implant for attachment to a surface of a bone ) 是由 温格·斯文奈恩 阿德姆·阿克苏 弗兰克·雷诺尔 海纳·怀尔德 于 2019-08-30 设计创作，主要内容包括：本发明涉及一种用于附接到骨骼(3)的表面(2)上的骨植入物(1),其具有基体(4),所述基体(4)的下侧面(5)和/或其上侧面(6)基本上对应于无变形的骨外轮廓(7),其中,所述基体(4)的外部尺寸如此地选择,使得所述基体(4)完全覆盖用于获取自体骨材料的有意引入的变形区域(8),其中,在所述基体(4)中存在至少一个开口(9),所述开口(9)的尺寸适于,使得所述开口(9)在使用中引导插入所述开口(9)中的骨标记工具和/或骨加工工具(10)。(The invention relates to a bone implant (1) for attachment to a surface (2) of a bone (3), having a base body (4), the lower side (5) and/or the upper side (6) of which substantially correspond to an undeformed bone outer contour (7), wherein the outer dimensions of the base body (4) are selected such that the base body (4) completely covers a deliberately introduced deformation region (8) for the purpose of obtaining autologous bone material, wherein at least one opening (9) is present in the base body (4), the dimensions of the opening (9) being adapted such that the opening (9) guides, in use, a bone marking tool and/or a bone processing tool (10) inserted into the opening (9).)

1. A bone implant (1) for attachment to a surface (2) of a bone (3), having a base body (4), characterized in that a lower side (5) and/or an upper side (6) of the base body (4) substantially corresponds to a non-deformed bone outer contour (7),

wherein the outer dimensions of the base body (4) are selected such that the base body (4) completely covers the intentionally introduced deformation region (8) for obtaining autologous bone material,

wherein at least one opening (9) is present in the base body (4), the size of the opening (9) being adapted such that the opening (9) guides, in use, a bone marking tool and/or a bone machining tool (10) inserted into the opening (9).

2. Bone implant (1) according to claim 1, characterized in that the opening (9) is provided as an elongated through hole allowing a penetration of the bone marking tool and/or bone machining tool (10) through the material of the base body (4) starting from the upper side (6) of the base body (4) and protruding from the lower side (5) of the base body (4).

3. Bone implant (1) according to claim 1 or 2, characterized in that there are a plurality of openings (9), wherein at least two openings (9) are arranged perpendicular to each other.

4. Bone implant (1) according to claim 1, characterized in that the outer contour (11, 12) of the base body (4) is designed as a guide surface for a bone marking tool and/or a bone treatment tool (10).

5. Bone implant (1) according to claim 1, characterized in that the opening edge (20) is provided inclined with respect to the upper side (6) of the base body (4) and/or its lower side (5).

6. Bone implant (1) according to claim 1, characterized in that the lower side (5) of the base body (4) is provided concave.

7. Bone implant (1) according to claim 1, characterized in that a plurality of openings (9) are spaced flush with each other by the material of the base body (4).

8. Bone implant (1) according to claim 1, characterized in that the bone implant (1) has fastening tabs (21) projecting outwardly from the base body (4).

9. Bone implant (1) according to claim 1, characterized in that said matrix (4) has a constant thickness.

10. Bone implant (1) according to claim 1, characterized in that the bone implant (1) is composed of or consists of a bioresorbable material or a non-bioresorbable material, such as a metal, and/or in that the bone implant (1) has a doping with anti-microbacterium properties.

Technical Field

The present invention relates to a bone implant for repairing or restoring a bone (osteotomy) condition and for attachment to a surface of a bone, in particular a skull.

Background

Bone implants for filling and/or closing defects and/or for reduction in the skull are known from the prior art. For example, document DE 202014103858U 1 discloses an implant for reducing and fixing a central lateral fracture (zentrocataleralen Mittelgesicchtsfroktur), wherein the implant comprises a plurality of pre-formed segments, preferably three or more pre-formed segments, wherein the first section is shaped in such a way that at least its lower side adjacent to the bone is completely or partially complementary to the anatomy of at least one partial region of the outer side of the maxilla, wherein the second section is shaped such that at least its lower side adjacent to the bone is completely or partially complementary to the lateral anatomy of the connection region between the maxilla and the cheek bone, and wherein the third section is shaped such that at least its lower side adjacent to the bone is fully or partially complementary to the anatomy of at least the outer partial region of the cheek bone.

Devices for guiding the separating tool are also known from the prior art. For example, document DE 102015107484 a1 discloses a bone connecting implant for connecting a first bone region with a second bone region or with a plurality of bone regions of a mammalian bone, including a first fastening region with a plurality of fastener receiving holes, which is prepared for attachment to the first bone region, and a second fastening region connected with the first fastening region, wherein the second fastening region in turn has a plurality of fastener receiving holes and is prepared for attachment to the second bone region, wherein a separating tool guiding profile of a predetermined dividing line is formed between the first fastening region and the second fastening region.

It is therefore known to correct bone misalignment using bone implants which individually adapt to the corrected bone misalignment and correspond to the correct position, thereby facilitating correction. It is also known to use bone implants to form a profile on the bone implant for correcting the misalignment, which profile guides a distraction tool so that a defined distraction profile can be easily introduced. However, no solution is known in the prior art by which autologous bone material can be obtained from defect-free bone regions, for example from the skull, relatively simply and with little influence on the patient, so that it can be transplanted elsewhere in the body to eliminate defects there.

Disclosure of Invention

It is therefore an object of the present invention to avoid or at least reduce the disadvantages of the prior art. In particular, a bone implant is provided which supports the removal of autologous bone material from non-deformed/defect-free areas, so that the necessary operative time for the removal is kept as short as possible, so that no negative influence is exerted on the patient.

The object of the invention is achieved according to the invention by a bone implant for attachment to a surface of a bone, for example the skull, wherein the bone implant has a base body, the underside of which substantially corresponds to the outer contour of a bone that is not deformed, for example to the outer contour of a skull that is not deformed, wherein the outer dimensions are selected such that the base body completely covers an intentionally introduced deformation region for obtaining autologous bone material, wherein at least one opening is present in the base body, which opening is dimensioned such that it guides, in use, a bone marking tool and/or a bone machining tool that is inserted into the opening. This means that the bone implant, in particular the base body of the bone implant, corresponds to the surface contour or surface bone layer in an intact, i.e. defect-free, bone region. Thus, the bone implant is not used to correct (natural) defects or dislocations, but to replace natural areas without changing its shape. In other words, the bone implant according to the invention corresponds to a surface bone layer or a bone plate of the skull region into which the bone implant is inserted. Thus, the area of the skull where the bone graft is inserted is not deformed before and after insertion. That is, the region of the skull bone into which the bone implant is inserted is not geometrically changed or is changed only as little as possible by the implantation of the bone implant.

A deformation is understood to be a (dent-like) defect in comparison with the surface region of the skull adjacent thereto, which is obtained, for example, by intentionally introduced, i.e. desired, bone removal. I.e. artificially introduced to obtain autologous bone material.

In this case, the base body has the opening, which serves as a marking guide contour and/or a separating tool guide contour for introducing the deformation/indentation. This has the advantage that, by a predetermined specification of a separation line through the substrate, which corresponds to the shape of the substrate, the artificial defect/deformation/indentation can be covered and/or closed again precisely by the substrate. Thus, the artificial defect for bone removal is not visible and therefore has little effect on the patient. In addition, the surgical time is greatly reduced by the introduction of the separation line.

Further, it is advantageous that the bone implant is used as a guide for a sawing tool, such that sawing can be performed when the bone implant is resting on the skull. This is particularly preferred when the skull is scratched, i.e. the surface is scratched.

Preferably, the opening is provided as an elongated through-hole which allows the passage of the bone marking tool and/or bone machining tool (hereinafter referred to as tool) from the upper side of the base body through the material of the base body and out of the lower side of the base body. The tool can thus be snapped through the base body in order to produce a marking line and/or a separating line in the cut formed by the opening. This means that the position of the marking line and/or the separating line is predetermined by the arrangement of the openings.

It is also advantageous if there are a plurality of openings, at least two of which are arranged perpendicularly with respect to one another. Thus, a plurality of compartments can also be formed or marked in the area covered by the base body. It is particularly preferred that the openings are predetermined in a pattern, for example a checkered pattern with rectangular and/or square and/or triangular cells, wherein the cells correspond in their shape to the desired bone plate shape (for implantation into the desired location). This means that the opening limits the defined shape.

Furthermore, it is advantageous if the outer contour of the base body is designed as a guide surface for a bone marking tool and/or a bone machining tool. That is, the tool is guided both along the opening in the base body and along the outer edge of the base body, thereby defining the separation line and/or the marking line. It is thus ensured that the matrix completely covers the intentionally introduced deformation region for obtaining autologous bone material, since only bone material within the outer contour of the matrix is removed.

It is particularly advantageous if the opening edge, i.e. the edge/side of the opening, and/or the side edge of the outer contour of the base body is/are inclined with respect to the upper side and/or the lower side of the base body. Thus, the engagement of the tool is not perpendicular to the surface of the skull, but is directed at an angle. Thereby supporting the removal of bone material, for example by means of a chisel.

For example, the opening edge and/or the side edges may be inclined between 30 ° and 60 °, in particular between 45 ° ± 3 °. Preferably, the side edges are inclined such that they are inclined inwardly, i.e. toward the center of the base body, starting from the upper side of the base body to the lower side of the base body. This means that the upper side of the base body is slightly larger than the lower side of the base body due to the oblique side edges. Preferably, the opening edge extends from the upper side to the lower side of the base body and is inclined toward the center of each cell, the opening edge defining the compartment.

According to an advantageous refinement, the underside of the base body is concave. In addition, it is possible to avoid the bone material protruding from the surface of the skull due to irregularities in the deformation region by predetermination of the defined contact points. Thus, a particularly smooth transition between the bone implant and the skull is ensured.

Preferably, a marking, preferably an arrow marking/direction marking, can be provided on the upper side of the base body, which marking indicates the implantation direction. This advantageously assists the surgeon in positioning and/or aligning the bone graft on the skull.

It is also advantageous to design the bone implant to produce a manufactured assembly. Thereby, the shape of the bone implant can be adapted particularly easily to the respective skull bone shape, resulting in an implant that is particularly precise in terms of curvature/bending ratio.

For example, the bone implant, in particular the substrate, may be made by additive means. This has the advantage that an implant corresponding to CAD data, which is generated, for example, by optical image processing, which corresponds to the shape of the skull bone, can be produced easily and inexpensively. Thus, a variety of different bone implants may be produced.

It is particularly preferred that the bone implant, in particular the matrix, has a mesh and/or lattice structure. This promotes ingrowth and/or resorption of the bone implant.

Furthermore, it is advantageous if the matrix comprises a doping, for example of silver, and/or only its surface comprises particles. By adding particles, an anti-microbial effect can be achieved, thereby reducing the risk of inflammation.

It is also advantageous that the plurality of openings are separated/spaced relative to each other by the (full) material of the substrate. Thereby, the bone implant has a sufficiently high stability despite the introduction of the opening. At the same time, the marking lines and/or separating lines can be introduced into the skull through the opening in such a way that they are easily realized.

Furthermore, it is preferred that the bone implant has fastening tabs, for example in the form of ears, which project outward from the base body. Thus, the bone implant may be fastened to the skull, for example by screws. This can be used when introducing separation lines and/or marking lines and/or for permanent fixation in the skull when covering the deformation region. The bone implant can also be used without fastening means, since the placement in a form-fitting manner is sufficient to be achieved by means of a precise form fit, so that the position of the bone implant is determined.

In a preferred embodiment, the substrate may have a constant thickness. Preferably, the fastening tab also has a constant thickness. Thus, a constant strength of the bone implant may be ensured. In an alternative embodiment, it may be advantageous for the substrate to have a non-uniform thickness. Thereby, irregularities of the bone structure may be advantageously repaired or different strength requirements may be met.

It is also advantageous to form holes provided as through-holes in the grid of the base body defined by the openings. Preferably, the aperture is arranged in the middle/centre of each respective compartment. Thereby, for example, a marking for marking the grid can be easily applied. In addition, the weight of the bone implant can thereby advantageously be reduced. This reduces material costs and manufacturing time.

Preferably, the holes are all the same size, i.e. all have the same diameter. Thereby obtaining the same bone plate.

Advantageously, the matrix has a pore structure, in particular micro-and/or macro-pores, which are adjustable during the production process. The ingrowth of the bone implant can be positively influenced by the size of the holes. In addition, the weight of the bone implant can thereby advantageously be reduced.

Furthermore, it is advantageous if the base body has a mesh structure, wherein the individual meshes/gaps have different mesh sizes. Thus, the structure of the matrix can be varied and adjusted within the matrix as desired.

It is also advantageous if the substrate has a chalk-like and/or glass/glass surface. Thus, advantageously, the material properties of the matrix can be influenced in a beneficial manner.

In addition, it is preferred that the bone implant is made of or consists of a bioresorbable material or a non-bioresorbable material, such as a metal for example, the bone graft may be made of tricalcium phosphate (α -TCP), β -tricalcium phosphate (β -TCP), Hydroxyapatite (HA), a mixture of β -TCP and HA, i.e., Biphasic Calcium Phosphate (BCP), in particular, a single structure made of β -TCP or HA, i.e., a structure that is substantially a single material, may prove advantageous β -TCP and HA, e.g., in the proportions of 50/50 or 75/25 or 25/75, have also proved to be particularly suitable.

In an alternative preferred embodiment, the bone implant may be formed of a light metal, preferably titanium, because titanium has particularly good compatibility in the human body.

In other words, the present invention relates to a bone implant for obtaining autologous bone material for augmentation and/or repair. In this case, an artificial defect is formed in the skull bone by bone removal, and the removed bone material is transplanted to the target area. According to the invention, the individually designed bone implant fills the formed defect. Bone structures are supported by a precision 3D bone implant and by simultaneous resorption of the bone implant. The engagement time is reduced because the bone implant is accurate and thus eliminates a lengthy adaptation process during engagement. At the same time, the bone implant serves as a guide for the removal of bone material, i.e. as a template, such that the defect is adapted to the shape of the bone implant. In this case, the bone implant may be made of resorbable or non-resorbable materials. In particular, the segments/lattices formed by the openings, corresponding to the shape of the removed bone material, may be pre-adapted to the area to be repaired at the target area.

Drawings

The invention is described below with reference to the drawings in the specification. Wherein:

fig. 1 shows a perspective view of a bone implant according to the invention, which is attached to the skull bone,

figure 2 shows a perspective view of the bone implant on its upper side,

figure 3 shows a perspective side view of the bone implant,

fig. 4 shows a perspective view of the bone implant rotated relative to fig. 2 and 3, an

Fig. 5-14 show perspective views of various steps of using the bone implant according to the present invention.

The figures are merely schematic and are used only for the understanding of the present invention. Like elements are identified by like reference numerals.

Detailed Description

Fig. 1 shows a bone implant 1 according to the invention for attachment at a surface 2 of a human skull 3. The bone implant 1 has a plate-shaped base body 4. The underside 5 of the base body 4 is a flat side or flat surface of the base body 4 which, in the attached state on the skull 3, faces the skull 3 and rests on the surface 2 of the skull 3. The upper side 6 of the base body 4 is a flat side or flat surface of the base body 4 which, in the attached state on the skull 3, faces away from the skull 3. The upper side 6 is thus placed opposite the lower side 5.

The lower side 5 corresponds, for example, in its curvature substantially to the non-deformed or defect-free outer contour 7 of the skull 3. The upper side 6 also corresponds, for example, in its curvature substantially to the deformation-free or defect-free outer contour 7 of the skull 3. The bone implant 1 thus corresponds to a bone layer or lamina with a flat surface in the skull 3 before removing bone material from the skull 3. Thus, that is to say, when the bone implant 1 is inserted into the skull bone 3 in place of bone material, the bone implant 1 is inserted flush, i.e. without shoulders (Absatzfrei), into the skull bone 3.

The outer dimensions of the base body 4 are selected such that the base body 4 covers a deliberately introduced deformation region 8 in the skull 3 for the purpose of obtaining autologous bone material (see fig. 10 to 12). The deformation region 8 is a region in the skull 3 in which a recess or depression, for example in the manner of a blind hole, is introduced, so that the surface 2 is depressed or set in comparison with the region without deformation, for example in comparison with the surface region adjacent to the deformation region 8. The groove is a defect artificially formed in the skull 3 and is formed by removing bone material of the skull 3. The deformed region is closed or covered by inserting the bone implant 1 in such a way that the bone implant 1 engages into the skull 3 and restores the natural, i.e. original, outer contour 7 of the skull 3.

In the base body 4 there is at least one opening 9, which is dimensioned such that it guides a tool 10 for bone marking and/or bone machining in use (see fig. 6) during bone removal, which tool 10 is inserted into the opening 9. The base body 4 thus serves both as an implant for covering or closing an artificially created defect and as a tool guide or tool guide for guiding a tool when removing bone material from the skull 3, i.e. when producing an artificial defect, such that the geometry of the defect corresponds to the shape of the bone implant 1.

Fig. 2 to 4 show different perspective views of the bone implant 1. The base body 4 has a rectangular shape or a rectangular outer contour and is bounded by two first side edges 11 or first side surfaces and two second side edges 12 or second side surfaces which are shorter than the first side edges 11. In the base body 4, openings 9 are present, which openings 9 penetrate the base body 4 as through-openings perpendicular to the upper side 6 or perpendicular to the lower side 5. Through the opening 9, a connection can be made from the upper side 6 to the lower side 5.

A plurality of first openings 13 and a plurality of second openings 14 are provided in the base body 4, the longitudinal axes of the first openings 13 being parallel to the first side edge 11 and the longitudinal axes of the second openings 14 being parallel to the second side edge 12. The first opening 13 is longer in the longitudinal direction than the second opening 14. The first openings 13 are arranged perpendicular to the second openings 14 such that a plurality of rectangular compartments 15 are formed through the openings 9 and the side edges 11, 12. In the embodiment shown, every third of said first openings 13 is arranged in alignment with respect to each other and every fourth of said second openings 14 is arranged in alignment with respect to each other, thereby forming twelve equally sized compartments 15. The first opening 13 and the second opening 14 aligned with each other are separated or separated from each other by the material of the base body 4.

In the base body 4, a plurality of third openings 16 and a plurality of fourth openings 17 are provided, the longitudinal axis of the third openings 16 being parallel to the first side edge 11 and the longitudinal axis of the fourth openings 17 being parallel to the second side edge 12. The third openings 16 are arranged in alignment with each other and are provided substantially the same length as the second openings 14 in the longitudinal direction. In the illustrated embodiment, said fourth openings 17 have different lengths in the longitudinal direction and every fourth of said fourth openings 17 are arranged in line with each other, i.e. their longitudinal axes are arranged in a straight line. The third opening 16 and the fourth opening 17 define two compartments 15 and two second compartments 18, the second compartments 18 having a larger area than the compartments 15. In each case one hole 19 is arranged centrally in the compartment 15, which hole 19 is designed as a through-hole and passes through the base body 4 perpendicularly to the upper side 6. Two holes 19 are arranged in the grid 18, respectively. The first, second, third and fourth openings 13, 14, 16, 17 form a checkered pattern on the substrate 4.

The opening edge 20 forming the side surface of the opening 9 and the first and second side edges 11, 12 are arranged to be inclined with respect to a plane perpendicular to the upper side 6 or to the lower side 5. The side edges 11, 12 are inclined inwardly with respect to the lower side 5, i.e. towards the centre of the base body 4. The opening edge 20 is inclined with respect to the lower side 5 towards the centre of the compartments 15, 18. The opening 9 is therefore narrower on the upper side 6 than on the lower side 5. The angle of inclination between a plane perpendicular to the upper side 6 or the lower side 5 and the opening edge 20 or the side edges 11, 12 is between 30 ° and 60 °.

In particular, it can be seen in fig. 3 that the base body 4 of the bone implant 1 is provided concavely curved. The base body 4 is not uniformly curved because its curvature is adapted to the skull 3. The substrate 4 has a constant/constant thickness.

A plurality of fastening tabs 21 project outwardly from the base body 4 of the bone implant 1. The fastening tab 21 is provided in the form of a plate and continues the curvature of the base body 4, so that the fastening tab 21 engages seamlessly into the base body 4. The fastening web 21 is designed in the form of a lug and has a fastening hole 22 designed as a through-opening, the fastening hole 22 penetrating the fastening web 21 perpendicularly. The fastening tab 21 has a constant thickness, which corresponds to the thickness of the base body 4. The base body 4 and the fastening tab 21 are integrally formed.

Fig. 5 shows a first step 23 in the use of the bone implant 1, in which the lower side 5 of the base body 4 is placed on the outer contour 7 of the skull 3 and positioned at a predetermined position where a deformation area 8 is to be created.

Fig. 6 and 7 show a second step 24 in which the tool 10 is used for bone marking and bone treatment. The tool 10 is inserted into the opening 9 and guided by the opening edge 20. In this way, a marking line and/or a separation line for removing bone material is introduced into the skull 3. The tool 10 is also guided along a first side edge 11 and a second side edge 12 of the substrate 4. Fig. 7 shows the result of using a tool, which shows the grid-like marked lines and/or separation lines 25 on the surface 2 of the skull 3.

Fig. 8 and 9 show a third step 26, in which the marking lines and/or separating lines 25 aligned relative to each other are connected to each other by the tool 10 so as to completely enclose the skull 27 corresponding to the compartments 15, 18. The skull bone 27 corresponds to a bone plate to be removed from the skull 3.

Fig. 10 shows the skull 3, from which skull bone material of the skull bone 27 has been removed from the skull 3. Thus, the deformation zone 8 is formed, the shape of which corresponds to the outer dimensions of the basic body 4. The depth of the deformation zone 8 is greater than the thickness of the matrix 4.

Fig. 11 and 12 show a fourth step 28, in which the groove 29 is introduced into the skull 3, the depth of the groove 29 corresponding to the thickness of the substrate 4. The shape of the recess 29 corresponds to the fastening tab 21.

Fig. 13 and 14 show a fifth step 30, in which the base body 4 of the bone implant 1 is placed on the deformation region 8 and the fastening tabs 21 are inserted into the recesses 29. Thereby, the deformation region 8 is completely closed by the bone implant 1. The upper side 6 of the base body 4 engages seamlessly into the outer contour 7 of the skull 3, so that a flush surface 2 of the skull 3 is achieved. The bone implant 1 may be screwed or simply inserted into the recess 29.

List of reference numerals

1 bone implant

2 surface of

3 skull

4 base body

5 lower side surface

6 upper side

7 outer contour of skull

8 deformation zone

9 opening

10 tool

11 first side edge

12 second side edge

13 first opening

14 second opening

15 checks

16 third opening

17 fourth opening

18 lattices

19 holes

20 opening edge

21 fastening tab

22 fastening hole

23 first step

24 second step

25 mark/separation line

26 third step

27 skull skeleton

28 fourth step

29 groove

30 fifth step