Positioning device for cranial bone portions, production method for positioning device and system comprising positioning device having fastening devices

Abstract

The invention relates to a positioning device (1) for cranial bone portions, for relative positioning of the cranial bone portions relative to each other and for obtaining a predefined overall shape and overall contour in order to achieve a target cranial shape, having a primary body (2) designed to bear the cranial bone portions, wherein the primary body (2) is produced based on individual patient data, which are specific for the patient to be treated, and supplemented by modified, anatomical data. The invention furthermore relates to a production method for producing such a positioning device (1), which is prepared to have cranial bone portions temporarily fastened to it, wherein in one manufacturing step, a primary body (2) of the positioning device (1) is produced, based on geometric data representative of the cranial bone geometry of the particular patient to be treated. The invention also relates to a system comprising a positioning device (1) according to the invention and a cranial-bone fastening device (16) for temporary fastening of a cranial bone portion to the primary body (2) of the positioning device (1) in order to orientate the cranial bone portions relative to each other, wherein a pin-shaped fixing element portion (17) is provided on the cranial-bone fastening device (16), which is designed to contact the cranial bone portion or several cranial bone portions on one side while interacting with a counter portion (18) arranged on the other side of the cranial bone portion or cranial bone portions to fasten it or them on the primary body (2) of the positioning device (1).

Claims

1. Positioning device (1) for cranial bone portions for relative positioning of the cranial bone portions to each other and for obtaining a predefined overall shape and overall contour to achieve a target cranial shape, with a primary body (2) designed to support the cranial bone portions, characterized in that the primary body (2) is created based on representatively individual patient data specific for the patient to be treated and supplemented by modified anatomical data, which is obtained by adjusting the statistically detected, undeformed skull shapes to deformed parts of the skull, taking into account the variations of the skull shape.

2. Positioning device (1) for cranial bone portions for relative positioning of the cranial bone portions to each other and for obtaining a predefined overall shape and overall contour to achieve a target cranial shape, with a primary body (2) designed to support the cranial bone portions, preferably according to claim 1, characterized in that the primary body (2) has a circumferential edge (4) and limits a carrying structure (5).

3. Positioning device (1) according to claim 2, characterized in that the carrying structure (5) has a net-like or lattice-like shape.

4. Positioning device (1) according to one of claim 2 or 3, characterized in that a holding element (3) protrudes outwards from the primary body (2) in order to hold, fasten, and/or clamp the positioning device (1).

5. Positioning device (1) according to claim 4, characterized in that the positioning device (1) has an inclination (15) on a rear side.

6. Positioning device (1) according to one of claims 2 to 5, characterized in that the primary body (2) is formed as a convex shell.

7. Positioning device (1) according to one of claims 2 to 6, characterized in that the carrying structure (5) has a plurality of recesses (7) or through-holes (7) which are spatially separated from each other by webs (6).

8. Positioning device (1) according to one of claims 2 to 7, characterized in that the positioning device (1) has a center line marking (13).

9. Production method for producing a positioning device (1), which is prepared to have cranial bone portions temporarily fastened to it, wherein in one manufacturing step, a primary body (2) of the positioning device (1) is produced, based on geometric data representative of the cranial bone geometry of the particular patient to be treated, and supplemented by modified anatomical data, which is obtained by adjusting the statistically detected, undeformed skull shapes to deformed parts of a skull, taking into account the variations of the skull shape.

10. System comprising a positioning device (1) according to one of claims 1 to 8 and a cranial-bone fastening device (16) for temporary fastening of a cranial bone portion to the primary body (2) of the positioning device (1) in order to orientate the cranial bone portions relative to each other, characterized in that a pin-shaped fixing element portion (17) is provided on the cranial-bone fastening device (16), which is designed to contact the cranial bone portion or several cranial bone portions on one side while interacting with a counter portion (18) arranged on the other side of the cranial bone portion or cranial bone portions to fasten it or them on the primary body (2) of the positioning device (1).

Description

[0061] The invention is explained in the following with the help of the drawings. These show:

[0062] FIG. 1 shows a perspective view of a positioning device according to the invention with a lattice structure in a first exemplary embodiment and a center line marking,

[0063] FIG. 2 shows a side view of the positioning device in the first exemplary embodiment of the lattice structure,

[0064] FIG. 3 shows a perspective view of a skull fastening device used for a system according to the invention with a counter portion and a fixing element portion,

[0065] FIG. 4 shows a perspective view of the cranial-bone fastening device with the fixing element portion screwed into the counter portion,

[0066] FIG. 5 shows a perspective view of the counter portion with a handle region and a bracing region,

[0067] FIG. 6 shows a perspective view of the fixing element portion with a handle region, a support region and a coupling region, and

[0068] FIG. 7 shows the skull fastening device in a perspective view.

[0069] The figures are merely schematic in nature and serve exclusively to understand the invention. The same elements are provided with the same reference signs.

[0070] FIG. 1 shows a positioning device 1 for cranial bone portions. The positioning device 1 is configured to position the cranial bone portions relative to each other and to maintain or create a predefined overall shape and overall contour of the cranial bone portions. The positioning device 1 has a primary body 2 on which the cranial bone portions are placed. Furthermore, the positioning device 1 has a handle part/holding element 3, which protrudes laterally, approximately at a right angle, from an edge 4 of the positioning device 1. The edge 4 is part of the primary body 2 and circumferentially limits a carrying structure 5, which is formed net-like/lattice-like and surrounds an imaginary hemispherical shape.

[0071] The carrying structure 5 is a convex shell and consists of webs 6 that limit several recesses/through-holes 7. The recesses have a hexagonal surface and form a kind of honeycomb shape 8. The recesses 7 are distributed evenly over the carrying structure 5 and are only separated from each other by the webs 6. The carrying structure 5 forms a round, approximately hemispherical shape. The carrying structure 5 extends only to one side of the edge 4, wherein the edge forms a circumferential, closed rim.

[0072] The webs 6 have a constant thickness and a square, in particular a trapezoidal cross-section. This means that the webs 6 have four surfaces, two of which are the main limiting surfaces 9 and two are secondary limiting surfaces 10. The main limiting surfaces 9 extend approximately in a radial direction of the positioning device 1 and approach each other from the inside to the outside. The secondary limiting surfaces 10, which extend in the circumferential direction, are arranged approximately parallel to each other.

[0073] A center line marking 13 extends from a front side 11 of the positioning device 1 to a rear side 12 of the positioning device 1. The center line marking 13 is a continuous recess 14 that extends from one side of the edge 4 to an opposite side of the edge 4. The front side 11 is the side of the positioning device 1 that would form the front side of the head if the positioning device 1 was placed over a skull like a helmet. Accordingly, the shape of the rear side 12 of the positioning device 1 corresponds to the occipital shape.

[0074] Following the recess 14 of the center line marking 13, the carrying structure 5 returns to its lattice-like/net-like/honeycomb-like structure with the webs 6 and the recesses 7. The carrying structure 5 forms an inclination 15 at the rear side 12, so that the carrying structure 5 does not enclose a complete hemisphere. In a side view (cf. FIG. 2) the edge 4 forms an obtuse angle within which the carrying structure 5 is arranged. The inclination 15 is positioned approximately at an angle of 45 to a horizontal.

[0075] At the front side 11 of the positioning device 1, the holding element 3 connects to the edge 4. The holding element 3 protrudes horizontally outwards from the primary body 2. The holding element 3 is formed with a constant thickness. The holding element 3 forms a surface, which is a rectangle with two rounded edges on the outer side. At the point of the edge 4 where the holding element 3 protrudes, the thickness/height of the edge 4 is increased as compared to the rest of the edge region. Overall, the primary body 2 is formed as a kind of convex shell with a thickness of about 2 to 5 mm.

[0076] The positioning device 1 is generated based on individual patient data by detecting comparative measurement points at the skull of the patient and calculating a virtual, desired cranial shape based on these points, which in turn are used to calculate geometric production data corresponding to the positioning device 1. The positioning device 1 is designed as a shell/helmet, which fits to the target cranial shape on the outside, so that the inside of the positioning device 1 can be used to adapt the shape of the cranial bone portions.

[0077] FIG. 2 shows a side view of the positioning device 1. Here it is particularly easy to see that the edge here partially extends in a horizontal direction and then bends upwards at an angle of about 45.

[0078] FIG. 3 shows a cranial-bone fastening device 16 which is designed for temporary fastening of a cranial bone portion to the primary body 2 of the positioning device 1. The cranial-bone fastening device 16 has a fixing element portion 17 and a counter portion 18. The fixing element portion 17 is pin-shaped and is designed to contact the cranial bone portion or several cranial bone portions on one side while interacting with the counter portion 18 arranged on the other side of the cranial bone portion or cranial bone portions.

[0079] The counter portion 18 has a handle region 19 and a bracing region 20. The handle region 19 is plate-like and has two wings 21 which protrude from both sides of a thickening 22 in the same plane. A round, circular indentation 23 is formed on each wing 21. The two indentations 23 are arranged on both sides of the thickening 22 at the same distance. The thickening 22 is arranged in a longitudinal direction of the handle region 19. Inside the thickening 22, a recess 24 is arranged longitudinally in the manner of a through bore 25.

[0080] The thickening 23 is of non-constant thickness so that it has a larger diameter in the two edge regions arranged in the longitudinal direction than in the middle region arranged in the longitudinal direction. The handle region 19 of the counter portion 18 has a coating that acts in a particularly anti-slip, i.e. slip-resistant, manner. The handle region 19 of the counter portion 18 transitions into the bracing region 20 of the counter portion 18.

[0081] The bracing region 20 extends approximately plate-like into a plane which is orthogonal to the longitudinal direction of the counter portion 18. The bracing region 20 is thus formed in such a way that it has a concave surface 26 and a convex surface 27, which together form a convex shell of the bracing region 20. The convex surface 27 of the bracing region 20 is the side facing the handle region 19. The concave surface 26, on the other hand, is the surface of the bracing region 20, which is facing away from the handle region 19, i.e. facing the fixing element portion 17 and in the mounted state the cranial bone portion or the positioning device 1.

[0082] The bracing region 20 is formed to be round, in particular oval, and has recesses 28, which are separated from each other by webs 29. An inside thread 30 is integrated in the through bore 25 within the thickening 22 of the handle region 19 and the bracing region 20. The inside thread 30 can extend over the entire length of the through bore 25 or only over a section of the through bore 25.

[0083] The counter portion 18 of the cranial-bone fastening device 16 is engaged by the fixing element portion 17 in the mounted state. The fixing element portion 17 consists of a handle region 31, which transitions via a web 38 into a support region 32, wherein the support region 32 is followed by a coupling region 33. The coupling region 33 consists of a thread region 34 and a threadless end pin 35, which ends with a thickening 36. The thread region 34 has an outside thread, which is adjusted to the counter portion 18 in such a way that the outside thread of the thread region 34 can engage with the inside thread 30 in the through bore 25.

[0084] FIG. 4 shows the cranial-bone fastening device 16 in a state in which the fixing element portion 17 with its thread region 34 is screwed into the inside thread 30 of the counter portion 18. The cranial bone portion is fixed to the positioning device 1 between the bracing region 20 of the counter portion 18 and the support region 32 of the fixing element portion 17 during use.

[0085] FIG. 5 shows an enlarged view of the counter portion 18. Here, it is particularly easy to see that the inside thread 30 is formed in the through bore 25. The counter portion 18 is arranged either on the inside of the positioning device 1 or on the outside of the positioning device 1. Since the cranial bone portions are arranged on the inside of the positioning device 1, the counter portion 18 contacts either the cranial bone portions on the inside, in particular with its bracing region 20, or the lattice structure/carrying structure 5 of the positioning device 1 on the outside.

[0086] FIG. 6 shows an enlarged view of the fixing element portion 17. The handle region 31, which has a central indentation 37, transitions into the support region 32 via the small web 38. The support region 32 is formed like an oval plate. Equivalent to the bracing region 20, the support region 32 has a concave surface 39, which is arranged on the side facing the coupling region 33 and is configured to contact the cranial bone portion or the positioning device 1, and has a convex surface 40, which is arranged on the side facing the handle region 31. The support region 32 is formed by webs 41, which separate several approximately triangular recesses 42 from each other.

[0087] The coupling region 33 is connected centrally to the support region 32. Between the support region 32 and the thread region 34, there is a thinned section of the coupling region 33, which serves as a predetermined breaking point 43 for protection against incorrect use. The predetermined breaking point 43 ensures that the coupling region 33 breaks off from the support region 32 when an excessive force is applied in the axial direction or in a direction orthogonal or inclined to the axial direction. The predetermined breaking point 43 is adjoined by the thread region 34, which is matched to the inside thread 30 of the counter portion 18.

[0088] The thread region 34 transitions into a threadless end pin 35. The end pin 35 is matched to the counter portion 18 in such a way that the length of the end pin 35 is at least as large as the length of the entire counter portion 18 in the longitudinal direction. This has the purpose that the end pin 35 can be passed through the through bore 25 of the counter portion 18 without the inside thread 30 and the thread region 34 interlocking. The thickening 36 is arranged at a distal end of the end pin 35. The through bore 25 has a larger diameter than the thickening 36. However, the through bore 25 has a tapering at an axial end (or at any point in the through bore 25), so that the through bore 25 has a smaller diameter in the area of the tapering than the thickening 36 of the fixing element portion 17. The thickening 36 thus serves as a loss protection. When inserting the fixing element portion 17, the thickening 36 of the fixing element portion 17 is elastically deformed in such a way that the thickening can be passed through the tapering/tapered section in the through bore 25. The thickening 36 thus prevents the fixing element portion 17 from slipping back through the through bore 25 of the counter portion 18 without any force, i.e. unintentionally.

[0089] FIG. 7 shows the two portions 17, 18 of the cranial-bone fastening device 16 in a state in which they do not interact. For fastening the fixing element portion 17, it is pushed through the through bore 25 of the counter portion 18 with its coupling region 33. The cranial bone portions to be fastened are clamped together with the positioning device 1 between the support region 32 and the bracing region 20. The coupling region 33 can either be passed through the cranial bone portions or it can be arranged between several cranial bone portions. The coupling region thus engages the counter portion 18 in such a way that the cranial bone portions are attached via the bracing region 20 and the support region 32, since they are held between the bracing region 20 and the support region 32 at the positioning device 1.

LIST OF REFERENCE SIGNS

[0090] 1 positioning device [0091] 2 primary body [0092] 3 holding element [0093] 4 edge [0094] 5 carrying structure [0095] 6 web [0096] 7 recess/through-hole [0097] 8 honeycomb shape [0098] 9 main limiting surface [0099] 10 secondary limiting surface [0100] 11 front side [0101] 12 rear side [0102] 13 center line marking [0103] 14 recess [0104] 15 inclination [0105] 16 cranial-bone fastening device [0106] 17 fixing element portion [0107] 18 counter portion [0108] 19 handle region [0109] 20 bracing region [0110] 21 wings [0111] 22 thickening [0112] 23 indentation [0113] 24 recess [0114] 25 through bore [0115] 26 concave surface [0116] 27 convex surface [0117] 28 recess [0118] 29 web [0119] 30 inside thread [0120] 31 handle region [0121] 32 support region [0122] 33 coupling region [0123] 34 thread region [0124] 35 end pin [0125] 36 thickening [0126] 37 indentation [0127] 38 web [0128] 39 concave surface [0129] 40 concave surface [0130] 41 web [0131] 42 recess [0132] 43 predetermined breaking point