Skull part positioning device, method for manufacturing positioning device and positioning device with fixing device system
阅读说明:本技术 颅骨部分定位装置,定位装置的制造方法以及定位装置带固定装置的系统 (Skull part positioning device, method for manufacturing positioning device and positioning device with fixing device system ) 是由 弗兰克·赖瑙尔 斯蒂芬妮·格罗姆 阿妮塔·格里戈雷 法伊特·伊里翁 恩斯特-约翰内斯·哈伯尔 于 2018-04-04 设计创作,主要内容包括:本发明涉及一种用于颅骨部分的定位装置(1),用于颅骨部分相对彼此的相对定位,并用于获得预定的整体形状和整体轮廓,以实现目标头骨形状,其包括设计为支撑颅骨部分的主体(2),其中该主体(2)基于特定于待治疗患者的个体患者数据生成,并由修改后的解剖数据补充。本发明还涉及一种用于生产这种定位装置(1)的制造方法。本发明还涉及一种包括根据本发明的定位装置(1)和颅骨固定装置(16)的系统。(The invention relates to positioning devices (1) for skull parts for relative positioning of the skull parts with respect to each other and for obtaining a predetermined overall shape and overall contour for achieving a target skull shape, comprising a body (2) designed to support the skull parts, wherein the body (2) is generated based on individual patient data specific to the patient to be treated and is supplemented by modified anatomical data the invention also relates to manufacturing methods for producing such positioning devices (1) the invention also relates to systems comprising a positioning device (1) according to the invention and a skull fixation device (16).)
positioning device (1) for skull portions for the relative positioning of the skull portions with respect to each other and for obtaining a predetermined overall shape and overall contour in order to achieve a target skull shape, comprising bodies (2) designed for supporting the skull portions, characterized in that said bodies (2) represent individual patient data specific to the patient to be treated and are generated supplemented by modified anatomical data obtained by matching statistically derived undeformed skull shapes to skull deformation sites while taking into account variations in the skull shape.
2. Positioning device (1) for skull portions for relative positioning of the skull portions with respect to each other and for obtaining a predetermined overall shape and overall contour to achieve a target skull shape, comprising bodies (2) designed for supporting skull portions, preferably according to claim 1, characterized in that the bodies (2) have circumferential edges (4) and bound supporting structures (5).
3. The positioning device (1) according to claim 2, wherein said support structure (5) is a mesh or grid-like structure.
4., the positioning device (1) according to claim 2 or 3, characterized in that holding elements (3) project outwardly from the body (2) for holding, fixing and/or clamping the positioning device (1).
5. The positioning device (1) according to claim 4, characterized in that the positioning device (1) has ramps (15) on its back side.
6. the positioning device (1) according to claims 2-5, characterized in that the body (2) forms convex hulls.
7. -the positioning device (1) according to claims 2 to 6, characterized in that the support structure (5) has a plurality of grooves (7) or through-holes (7), which grooves (7) or through-holes (7) are spatially separated from each other by webs (6).
8., the positioning device (1) according to claims 2-7, characterized in that the positioning device (1) has a centre line marking (13).
Manufacturing method for producing a positioning device (1), said positioning device (1) being intended for temporarily fixing a skull portion thereto, wherein, in manufacturing steps, bodies (2) of the positioning device (1) are produced on the basis of geometric data representing the skull geometry of a specific patient to be treated, supplemented by modified anatomical data obtained by matching a statistically derived undeformed skull shape to a deformed part of the skull and taking into account variations in the skull shape.
10, system comprising a positioning device (1) according to of claims 1 to 8 and skull fixation devices (16) for temporarily fixing skull portions to the body (2) of the positioning device (1) for aligning the skull portions relative to each other, characterized in that on the skull fixation device (16) there is provided a pin-like fixation element portion (17) designed for contacting the skull portion or portions on the side for interacting with a mating portion (18) on the other side of the skull portion or portions for fixing the skull portion or portions to the body (2) of the positioning device (1).
Technical Field
The present invention relates to positioning devices for skull portions for relative positioning between the skull portions and for obtaining a predetermined overall shape and contour to achieve a target skull shape, comprising bodies designed for supporting the skull portions, furthermore, manufacturing methods for producing the positioning devices, and positioning devices to which or more fixation devices for positioning the skull portions are attached or can be attached, wherein the fixation devices are designed for temporarily fixing the skull portions to the positioning devices.
Background
To correct the skull deformities, the deformed skull portion is typically surgically reshaped to an undeformed shape.
Furthermore, EP2522289A1 discloses three-dimensional models of full-size human skull, including a forehead portion, a crown portion, and an occipital portion, that can be sterilized.
However, the prior art always has disadvantages, namely the use of a positioning device representing a generic child's skull model to reposition the skull portion, but even if there is a large number of skull models available for selection, a single target skull can only partially or mostly match the average model.
Disclosure of Invention
In particular, positioning devices will be developed which can optimally fit individual skull bones, the modelling of which is considerably easier since the surgeon no longer needs to manually adjust the skull.
The object of the invention is inventively solved by the fact that the body of the positioning device is based on individual patient data, which data are specific to the patient to be treated and are supplemented by modified anatomical data, for example generated in a processing step like .
The target skull shape is defined from the geometric data of a healthy, undeformed skull by calculating the average shape of the shape and most/all of the characteristic changes.the corresponding geometric points of each skull surface are determined by transferring/projecting/applying the anatomically relevant region from skull shapes to another skull shapes, thereby minimizing the measured deformation of the deformed region by these modified anatomical data, which is obtained by matching the statistically obtained undeformed skull shape to the deformed portion of the skull and taking into account the change in the skull shape, a single target skull shape can be calculated which adapts and corrects the deformed portion of the skull resulting in undeformed skull.
An advantage of the present invention is that by means of the positioning means, the repositioned skull portion can easily be formed into a single target skull shape. Thus, the removed skull portion can be easily placed outside or inside the positioning device and adapted to its shape for optimal results. Manual individual adjustment and correction of deviations of the model based on the average skull is no longer necessary, since a single target skull shape has been considered as a suitable body for building a positioning device. It is advantageous if personal data relating to the skull is allowed to be used to calculate a single target skull shape.
According to the invention, the object of the invention is also achieved by using a positioning device for skull portions for relative positioning between the skull portions and for obtaining a predetermined overall shape and contour to achieve a target skull shape, comprising bodies designed for supporting the skull portions, the bodies having a circumferential edge and bounding a supporting structure.
Advantageous embodiments are claimed in the following subclaims and are further described below.
It is also advantageous if the edge is closed, since this increases the stability of the positioning device. Thus, the rim serves as a floor/base and as a limitation of the support structure for placement of the modeled skull portion.
Furthermore, advantageous embodiments are characterized in that the support structure is located only on the side of an imaginary through-edge surface or plane.
Furthermore, it is advantageous if the surface is defined by a common intersection point of a plurality of planes. Thereby, the edge has an almost flat outer edge, which can also be used as a horizontally aligned orientation of the positioning means.
Furthermore, it is advantageous if the body, for example in the region of the rim and/or the support structure, has grip portions/holding elements projecting outwardly for holding, connecting and/or clamping the positioning device.
Grip/holding element gripping is particularly advantageous if the grip/holding element projects at an approximate or exact right angle to the main body at the common contact point, hi particular, the grip/holding element may project in a horizontal direction, as this further improves the direction in which the skull portion is placed.
It is also advantageous if the edge has an approximately constant thickness and/or height over the circumference, the stability over the circumference being constant, and the tension over the edge being uniform, however, the thickness and/or height may also be greater or smaller at places along the edge size distribution, for example in the region of the retaining element.
advantageous embodiments are characterized by the edge region in the region of the protruding grip part/holding element having an increased and/or thickened portion, which makes it possible to connect the grip part/holding element more firmly to the body of the positioning device, thus ensuring better power transmission.
This is also useful if the support structure is mesh or grid-like, aspect is advantageous for reducing the weight of the support structure and thereby improving maneuverability, and aspect allows penetration of fixation elements for temporary fixation of the skull portion to the positioning device.
Furthermore, it is advantageous if the support structure has a grid structure, a mesh structure or a cross-line structure, which is advantageous for ensuring an optimum strength of the support structure at low weight.
The body can also be designed as a convex shell and/or have a preferably constant thickness. It is particularly important that the side or surface of the body on which the skull portion is placed, in particular the inner side/inner surface, is convex as it matches the typical skull shape. In particular, it is advantageous if the body is approximately hemispherical.
The body of the positioning device may be shaped like a helmet , i.e. the inside of the body is attached to the outside of the skull bone, thus the skull bone part may be placed inside and form the target skull bone shape.
This point is furthermore very useful if the support structure has a number of grooves or through holes which are spatially separated from each other by webs, whereby these grooves or through holes advantageously allow penetration (for fixation elements) of the support structure, which is particularly important for connecting the skull portion to the support structure.
It is advantageous if the web forms a polygon, for example a geometry defined as a regular polygon, such as a honeycomb structure and/or a hole with a continuous circular outer contour, for example an equilateral hexagon, the web thus enabling the part of the fixation element for fixing the skull portion to be attached to the support structure and the other part of the fixation element to penetrate the groove.
Furthermore, this point is very useful if the geometry and/or the outer contour of the surface of all or part of the through-hole match, whereby the same fixing element can be used at different/all points on the support structure.
Furthermore, advantageous embodiments are characterized in that the through hole has the configuration/design of system , whereby it does not matter in which direction the fixation element passes through the through hole, in particular when rotating around the radial extension direction of the positioning device.
If the through-holes have a circular, slightly circular, oval or elliptical surface, they can also reliably engage advantageous fixing element embodiments matching them.
Further, this point is useful if the web has a constant and/or similar thickness, which ensures that there are no local weak points or tension spikes in the web.
Furthermore, it is also advantageous if the web has a trapezoidal or triangular cross section, which further supports the convex design of the support structure.
The web may also have quadrangular cross sections, wherein the two main boundary surfaces mainly converge in radial direction and the two secondary boundary surfaces delimiting the two main boundary surfaces are arranged parallel to each other, whereby the web forms a larger surface at the inside of the support structure than at the outside, which is advantageous for providing a larger support surface for the skull bone part.
It is also advantageous if the two main boundary surfaces converge towards each other, seen from the inside outwards, for example forming an angle between 20 ° and 45 °, for example 30 °, 33 ° and 35 °.
Furthermore, it is advantageous that at least webs or all webs have an aspect ratio of 10/3 ± 10% and/or a longitudinal/thickness ratio of 10/3 ± 10%, which thereby ensures good power transmission between the webs.
Basically, advantageous embodiments are characterized by the fact that the height of the edge is 2-4 times the web thickness or width, the retention of shape being ensured by additional reinforcement at the edges of the support structure.
It is also advantageous if the back of the positioning device has ramps, in which case the back is usually the side where the part of the skull that is located at the back of the head is located.
It is particularly advantageous if the ramp deviates at an angle of 30 ° to 60 °, preferably 40 ° to 50 °, and further steps preferably 25 °.
Furthermore, it is suitable that the positioning device has a midline marker. This allows the surgeon to clearly see how the skull portion is placed, since he obtains a better positioning.
It is also advantageous if the centre line marking is formed by a web or a correspondingly extending groove extending from the th area of the edge to the opposite area of the edge.
It is also useful if the body is made entirely or partly of plastic. Plastics are particularly useful in medical applications because many plastics can be sterilized and used in many areas.
Another preferred is when the body is made entirely or partially of polyamide, which has particularly advantageous cost and weight characteristics, suitable for this application.
It is also advantageous if the positioning device has a non-slip coating, since it can be better held or handled and effectively prevents accidental slipping.
The object of the invention should also be achieved by manufacturing methods for producing positioning means for temporarily fixing skull portions, wherein in the manufacturing step, bodies of positioning means are to be provided/produced/created on the basis of geometric data representing the skull geometry of the particular patient to be treated.
It is advantageous if the geometric data of the patient are acquired in a reference step/measurement step preceding the manufacturing process and optionally further processed .
The geometric data can also be obtained in the reference step by photometry and/or photometry, preferably avoiding radiation to the patient, and is therefore particularly recommended for children.
In particular, skull measurement points are used as measurement points for the geometric data, since starting from several skull measurement points, a typical target skull shape can be calculated using a calculation formula. This means that no mean or statistical evaluation is required anymore, but a single, perfectly matching target skull shape can be calculated.
If skull measurement points are measured, at least measurement points are appropriate for measuring glabellar, posterior skull, platysma, orbit, nasion, chin, inframandibular point, tons, mandibular angular point, forehalogen, herringbone point, zygomatic point, superior border point of the outer ear , mastoid, basilic point, inion bump or parietal point.
It is advantageous if a virtual target skull model (a skull having a desired shape) is calculated/created based on the geometric data. Thus, the target skull model corresponds to a skull model without deformation.
Furthermore, it is also advantageous to use the virtual target skull model to construct the inner surface of the positioning device such that it corresponds exactly to the outer surface of the target skull. This advantageously allows the deformed skull portion to be formed into the desired shape by attachment to the positioning device. It is therefore advantageous if the positioning device is designed such that its inner surface corresponds to the outer surface of the target skull.
It is also valid if the representative geometry values for the virtual target skull model are converted into production geometry data by means of a conversion step, on the basis of which the positioning device, its body and, for example, the holding part/retaining element are produced in a production step.
It is advantageous if the geometric data are first obtained, then the geometric values, i.e. the target skull shape, are calculated on the basis of the geometric data, and then the manufacturing geometric data are calculated, which correspond to the inside of the "helmet" or body or the outside of the target skull model. The production positioning device is then provided on the basis of these manufacturing geometry data.
Furthermore, it is advantageous if the positioning device is produced by additive manufacturing, for example by 3D printing. In this way, all shapes can be created/printed in a short time and at an acceptable cost based on manufacturing geometry data.
The object of the invention is also achieved by a positioning device comprising skull fixating/fixing devices for temporarily fixing a skull portion to the positioning device.
The fixation device preferably has a fixation element portion designed to contact the skull portion or portions directly on one side at side in order to interact with a mating portion located on the other side of the skull portion or portions to fix the skull portion or portions to the main body.
The fixation device may be constructed in at least two parts, wherein part of the fixation device forms a fixation element part having a pin, wherein the fixation member part is dimensioned to extend in a fixed state from the side of the skull portion to the further side of the skull portion, and the further part of the fixation device forms a mating part adapted to receive the fixation element part for attaching the skull portion to the positioning device.
The mating portion has grip regions and bracing regions the fixation element portion has grip regions, bracing regions and coupling regions with threads and pins.
The object of the invention is also achieved by a method according to the invention for treating a patient in the head region, such as a human child.
It is advantageous if the geometric data of the patient are first obtained, then the geometric values of the virtual target skull model are calculated and on the basis thereof the manufacturing geometric data of the positioning device are calculated.
It is advantageous to generate the positioning device during the generation process prior to surgery. Thus, the operation can be performed in the shortest time.
It is also advantageous to place the removed skull portions in a positioning device and align them with each other so that they generally form closure zones.
Suitably, the skull portion aligned with or more skull fixation devices/fixtures is attached to the body of the positioning device.
The portion of the skull forming the matching shape can then be fixed at by approximately strip-shaped implants, thereby maintaining the position.
The interconnected skull portions can then be removed from the positioning device and then re-implanted into the skull.
Drawings
The invention is illustrated below with the aid of the figures. As shown in the attached drawings:
FIG. 1 is a perspective view of a positioning device according to the present invention having a grid structure and centerline markings in embodiment ;
FIG. 2 is a side view of a positioning device in an th embodiment having a lattice structure;
FIG. 3 is a perspective view of a cranial fixation device having mating portions and fixation element portions for a system according to the present invention;
FIG. 4 is a perspective view of the skull fixation device with the fixation element partially screwed into the mating portion;
FIG. 5 is a perspective view of the mating portion with the grip region and the support region;
FIG. 6 is a perspective view of a fixation element portion with a grip region, a support region, and a coupling region; and
FIG. 7 is a perspective view of the skull fixation device.
These figures are merely schematic in nature and are only used for an understanding of the present invention. Like elements have like reference numerals.
Detailed Description
Fig. 1 shows positioning devices 1 for skull portions the positioning device 1 is designed for relative positioning between skull portions and for obtaining or creating a predetermined overall shape and overall contour of the skull portion the positioning device 1 has main bodies 2 on which the skull portions are placed, furthermore, the positioning device 1 has grip part/holding
The
The
The centerline marking 13 extends from the
The
On the
The positioning apparatus 1 is generated from data of a single patient by detecting comparative measurement points on the skull of the patient and calculating a virtual target skull shape based thereon, which in turn are used to calculate manufacturing geometry data according to the use of the positioning device 1. In this case, the positioning device 1 is designed as a shell/helmet that externally conforms to the target skull shape, so that the inside of the positioning device 1 can be used to adapt the shape of the skull portion.
Fig. 2 shows a side view of the positioning device 1. It is particularly easy to see here that the edge here extends partly in the horizontal direction and then curves upwards at an angle of approximately 45 °.
Fig. 3 shows a
The
The thickened
The
The
The
FIG. 4 shows the
Fig. 5 shows an enlarged view of the
Fig. 6 shows an enlarged view of the
The
The threaded
Fig. 7 shows the two
List of reference numerals
1 positioning device
2 main body
3 fixing element
4 edge
5 support structure
6 web
7 grooves/through-holes
8 honeycomb
9 main boundary surface
10 sub boundary surface
11 front side
12 back side
13 center line marking
14 groove
15 slope
16 skull fixing device
17 fixing element part
18 mating part
19 area of grasp
20 support area
21 wing
22 thickened part
23 recess
24 groove
25 through hole
26 concave surface
27 convex surface
29 web
30 internal screw thread
31 grasping area
32 support area
33 coupling region
34 threaded portion
35 end pin
36 thickened part
37 recess
38 web
39 concave surface
40 convex surface
41 Web plate
42 groove
43 predetermined breaking point
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