EP4051142A1

EP4051142A1 - Method for creating a bone-fragment-specific drilling jig set for the formation of drilled holes for a perforated osteosynthesis plate, and corresponding device and drilling jig set

Info

Publication number: EP4051142A1
Application number: EP20811993.3A
Authority: EP
Inventors: Jürgen Mehrhof
Original assignee: Individual
Current assignee: Individual
Priority date: 2019-12-04
Filing date: 2020-11-20
Publication date: 2022-09-07
Also published as: DE102019218856A1; WO2021110444A1

Abstract

The invention makes available a method for creating a bone-fragment-specific drilling jig set for the formation of drilled holes for an osteosynthesis plate. The method involves a virtual presentation of a repositioned arrangement of a first and a second bone fragment (K1, K2) for the reconstruction of an intact form of a bone (K); a virtual arrangement of a perforated osteosynthesis plate (OP), which has been selected and is to be used, on the repositioned arrangement; an at least partial virtual imaging of the hole arrangement (LA) of the selected osteosynthesis plate (OP) arranged on the repositioned arrangement; creation of data of a first drilling jig (S1) with a first drilling jig hole arrangement (LA1') for the formation of drilled holes (BL) on the first bone fragment (K1), and creation of data of a second drilling jig (S2) with a second drilling jig hole arrangement (LA2') for the formation of drilled holes (BL) on the second bone fragment (K2; K2'). The data of the drilling jigs (S1, S2) are created in such a way that these have a respective associated mechanical and/or optical indicator device (KO1, KO2) which permits low-tolerance or tolerance-free positioning. (Fig. 1e)

Description

description

title

Method for creating a bone fragment-specific drill hole template set for

Formation of boreholes for a perforated osteosynthesis device and corresponding

Fixture and drill hole template set

The present invention relates to a method for creating a bone fragment-specific drill hole template set for forming drill holes for a perforated osteosynthesis device and corresponding device as well as a corresponding drill hole template set.

Although it can be applied to any perforated osteosynthesis devices, the present invention and the problems on which it is based are explained in relation to perforated osteosynthesis plates or perforated intramedullary nails.

State of the art

An osteosynthesis is carried out after bone fractures to stabilize the bone fragments, in stiffening operations on joints or on the spine and after osteotomies to correct misalignments. Further indications are stabilization in the case of bone tumors or to stabilize the bone at risk of fracture, such as B. in vitreous bone disease.

The goal of osteosynthesis is a stable fixation of the related bone fragments in order to enable an early functional follow-up treatment with partial load and in some cases even full load of the fixed bones. Then no further immobilization z. B. necessary in a plaster cast, and the resulting damage can be avoided.

In addition, the osteosynthesis should connect the bone fragments in a correct and corrected position in order to avoid misalignments, shortening and rotational errors. Particularly in the case of bone fractures with joint involvement, an anatomically exact and step-free restoration of the joint must take place in order to avoid post-traumatic joint wear and misalignment. Bone fractures with translational and rotational dislocations often occur, particularly in the area of the long tubular bones. Surgical repositioning and supply with perforated osteosynthesis devices are considered standard. Plates can be attached to the bones from the outside (osteosynthesis plates) or from the inside (intramedullary nails). These osteosynthesis plates and intramedullary nails have a predefined design that takes the biomechanical loads into account.

A particular difficulty in such operations is the precise repositioning of the bone fragments to one another. Rotational errors often occur between the proximal and distal bone fragments. In addition to an initial X-ray imaging (2-dimensional or 3-dimensional), intraoperative X-ray imaging is used to check the repositioning.

In modern individual medicine, more and more patient-specific manufactured implants are used. For example, in the facial area, various individually made "cutting / drilling guides" are used in order to be able to insert patient-specifically manufactured implants precisely.

In other areas, such as the extremities, certain physical and mechanical conditions must be observed in order to avoid implant failure. For this reason there is a large number of different osteosynthesis plates and intramedullary nails that have been tested for specific properties and are prefabricated.

Thus, there is always a problem in applying the perforated osteosynthesis devices intraoperatively to the bone fragments in the correct alignment and at the same time making the drill holes for the fixation pins required for fixation, e.g. fixation screws or fixation nails.

EP 3 012 759 A1 describes a method for planning, preparing, accompanying, monitoring and / or final control of an operative intervention in the human or animal body, in particular for the use of at least one implant, in which at least two multi-dimensional representations with the aid of an image assistance device at least one section of the body are shown, of which at least two representations differ in terms of the number of dimensions of the representation, the multi-dimensional representations being recognized and processed before, during or after their representation with the aid of the image assistance device and the image assistance device information and / or data on implants and / or 2D and / or 3D representations of implants are made accessible and at least one The patient image is recognized and processed before, during or after its display with the aid of an image assistance device in a working display and wherein the at least one multi-dimensional display can be compared with a reference model and wherein the 2D and 3D patient images are assigned to one another and the image assistance device with An interface transmits online data during the surgical intervention to display, auxiliary, measuring and imaging recording devices, and the image assistance device for planning, accompanying, monitoring and / or final control of an operative intervention, reference data, target values, standard values and / or General, patient-unspecific data and / or information on implants are provided, which are compared with standard values before they are provided.

WO 2011/136775 A1 describes a method for adapting a preformed implant for use in orthognathic surgery of an upper jaw, the method comprising: obtaining a preoperative 3D model of the upper jaw of a patient in a computer, with a first part of the upper jaw and a second part of an upper jaw define a first relative position; Manipulating the preoperative 3D model of the upper jaw into a planned postoperative shape, wherein the first part of the upper jaw and the second part of the upper jaw define a second relative position that is different from the first relative position; and custom designing a bone fixation implant to conform to the planned post-operative shape of the maxilla, the implant including a plate member preformed for attachment to the first portion of the maxilla and at least one finger extending from the plate member shaped for attachment to the second part of the upper jaw extends.

WO 2017/182527 A1 describes a method for providing rail sections of a multi-part bone processing guide rail before they are introduced into a human and / or animal body, with the following steps: acquisition of data from a patient for whom the bone processing guide rail is intended; Creating a model based on the collected data; Creation of manufacturing specifications for at least two or more rail sections that can be assembled to form a bone processing guide rail on the basis of the created model, the manufacturing specifications including dimensioning of the rail sections and production of the rail sections on the basis of the manufacturing specifications, and wherein the rail sections can be assembled together to form a bone processing guide rail.

DE 10 2008051 532 A1 describes a method for the preoperative adaptation of a previously selected implant blank, which is used to fix fracture fragments of a bone, to the Outer contour of the bone by bending, in which a digital 3D model of the implant blank in the unbent state together with a digitized X-ray image showing the bone with the help of an image processing program already repositioned fracture fragments is displayed on a screen and the digital 3D model is virtually bent, in order to adapt it to the outer contour of the bone shown, the curved digital 3D model being used as a template for bending the implant blank and a data set of the digital 3D model including deformation-specific parameters of the implant blank.

US 5,403,321 A discloses a radiolucent drill guide for connection to the proximal end portion of an intramedullary nail for aligning a drill with bores of an intramedullary nail when the nail is surgically positioned in a patient's medullary canal.

Disclosure of the invention

The present invention provides a method for creating a bone fragment-specific borehole template set for forming boreholes for a perforated osteosynthesis device according to claim 1 and a device for creating a bone fragment-specific borehole template set for forming boreholes for a perforated osteosynthesis device according to claim 11 and a borehole template set according to claim 15.

Preferred developments are the subject of the respective subclaims.

Advantages of the invention

The inventive method for creating a bone fragment-specific drill hole template set for forming drill holes for a perforated osteosynthesis device according to claim 1 and the corresponding device according to claim 11 and the drill hole template set according to claim 15 allow the hole pattern of existing osteosynthesis devices to be implanted to be taken into account and, at the same time, the hole bores to be accurately positioned the displaced bone fragments are transferred so that the desired position of the bone fragments is automatically set after the osteosynthetic fixation.

The initial images of the bone fragments are used to carry out a virtual repositioning of the bone fragments. Through a manual virtual or an automatic virtual repositioning by means of a statistical shape model, the bone fragments can be set in an anatomically correct position.

The desired implant can be selected from an implant database and properly positioned on the virtual repositioned bone. This position defines the hole positions, which can then be transferred to a drill hole template set.

During the operation, the drill hole templates are anatomically clearly attached and the drill holes for the drill holes are carried out on the respective bone fragment. The implant can then be positioned by searching for the corresponding screw positions and automatically repositions the bone fragments into the correct position.

According to a preferred embodiment, the data are created in such a way that the first and / or second drill hole template has an optical indicator device, in particular in the form of one or more optical markers corresponding to geometric or other features of the associated bone fragment.

According to a further preferred embodiment, the data are created in such a way that the first and / or second borehole template has an indicator device in the form of a contour of the respective borehole template, which can be positioned on the associated bone fragment in an anatomically adapted manner. This enables particularly precise and stable positioning.

According to a further preferred embodiment, the data are created in such a way that the first and / or second borehole template has an indicator device in the form of a distance indicator of the respective borehole template, which can be positioned at one end of the associated bone fragment. This is another easy way to accurately position the drill hole template.

According to a further preferred embodiment, a perforated osteosynthesis device to be used is selected manually or automatically from a database. In this way, the operator can be offered a large number of possible alternatives.

According to a further preferred embodiment, the creation of the pictorial representation takes place by means of two- or three-dimensional X-ray structure analysis data. Such data are easy to generate and quickly available. According to a further preferred embodiment, the virtual formation and display of the repositioned arrangement of the bone fragments takes place using a predetermined statistical model. This makes repositioning easier and eliminates inaccuracies on the part of the operator.

According to a further preferred embodiment, the virtual formation and display of the repositioned arrangement of the bone fragments takes place manually using a graphic input device. This allows a certain flexibility in the case of complicated bone fractures, in which an unambiguous automatic reduction is difficult.

According to a further preferred embodiment, the data of the borehole templates are output to a production device for producing the borehole templates, in particular a milling device or a three-dimensional printer. This enables the most extensive automation of the setting process for the drill hole templates.

According to a further preferred embodiment, the perforated osteosynthesis device is an osteosynthesis plate or an intramedullary nail.

Brief description of the drawings

The present invention is explained in more detail below with reference to the exemplary embodiments specified in the schematic figures of the drawings.

Show it:

1 a) -i) schematic cross-sectional representations of a course of supply of a bone fracture to explain a method for creating a bone fragment-specific drill hole template set for forming drill holes for a perforated osteosynthesis device according to a first embodiment of the present invention;

FIG. 2 shows a flow chart to illustrate the method steps carried out according to FIGS. 1a) -i); FIG.

3 shows a block diagram to explain a device for creating a bone fragment-specific drill hole template set for forming Drilling holes for a perforated osteosynthesis device according to a second embodiment of the present invention;

4 shows a schematic cross-sectional illustration to explain a bone fragment-specific drill hole template set for forming drill holes for a perforated osteosynthesis device according to a third embodiment of the present invention; and

5a) -e) schematic cross-sectional representations of a course of supply of a bone fracture to explain a method for creating a bone fragment-specific drill hole template set for forming drill holes for a perforated osteosynthesis device according to a fourth embodiment of the present invention.

Embodiments of the invention

In the figures, identical reference symbols denote identical or functionally identical elements.

1a) -i) show schematic cross-sectional representations of a course of supply of a bone fracture to explain a method for creating a bone fragment-specific drill hole template set for forming drill holes for a perforated osteosynthesis device according to a first embodiment of the present invention, and FIG. 2 shows a flowchart for showing the according to FIG 1a) -i) performed method steps.

With reference to FIG. 1 a) and method step S1 in FIG. 2, a pictorial representation, for example a computed tomography or X-ray representation, of a bone fracture of a bone K belonging to a human extremity, for example a leg or an arm, is shown. The bone K is split by the bone fracture into a first bone fragment K1 and a second bone fragment K2, between which a fracture gap SP extends. Other neighboring intact bones are denoted by reference symbols K 'and K ″ and the surrounding soft tissue by reference symbol W. The graphic representation, which was created here for example by means of two-dimensional or three-dimensional X-ray structure analysis data, is displayed on a display device 30, for example a monitor (cf. Fig. 3). With further reference to FIG. 1b) and method step S2 in FIG. 2, a reduced arrangement of the first and second bone fragments K1, K2 for reconstructing an intact shape of the bone K is virtually formed and displayed using the pictorial representation. In this case, the first and second bone fragments K1, K2 are repositioned into the intact shape on the display device 30 either using a manual input device 40 (see FIG. 3), or this is done by means of a predetermined algorithm using a predetermined statistical model for the intact one Shape of the bone K after a corresponding user input. The repositioned arrangement of the bone fragments K1, K2 is thus shown virtually on the display device 30 (FIG. 3). In particular, the repositioning regularly includes translational and rotational movements of the two bone fragments K1, K2.

In a further step, which is shown in FIG. 1c) or method step S3 in FIG. 2, a perforated osteosynthesis device OP to be used for fixing the first and second bone fragments K1, K2 with a hole arrangement LA, which extends over the two bone fragments K1, K2 extends. In the present case, the osteosynthesis device OP is an osteosynthesis plate. The correctly arranged osteosynthesis device OP is shown in the position in which it should be after an operation to be carried out later. The selection takes place either manually or automatically using a database 60 (cf. FIG. 3) in which a plurality of predetermined osteosynthesis devices with corresponding hole arrangements is stored. After the final position has been determined, a first part of the hole arrangement LA is located above the first bone fragment K1 and a second part of the hole arrangement LA is located above the second bone fragment K2.

As shown in Fig. 1d) and method step S4 in Fig. 2, the hole arrangement LA is then at least partially imaged on the repositioned arrangement of the two bone fragments K1, K2 using a corresponding algorithm virtually by a corresponding projection and on the display device 30 (cf. . Fig. 3). The hole arrangement LA has a first part LA1, which is located on the first bone fragment K1, and a second part LA2, which is located on the second bone fragment K2. Although in the present case the entire arrangement of holes LA is mapped onto the repositioned arrangement of the two bone fragments K1, K2, this does not necessarily have to be done in this way, but in certain cases it may also be sufficient to virtually only part of the arrangement of holes LA on the repositioned arrangement of the two Bone fragments K1,

K2, for example if not all holes of the hole arrangement LA are to be used later for the introduction of fixing devices during the operation, or some of them just a few holes ensure correct intraoperative alignment of the OP osteosynthesis device.

In a further step with reference to FIG. 1e) and method step S5 in FIG. 2, data from a first drilling template S1 and a second drilling template S2 with a respective drilling template-hole arrangement LA1 ', LA2' are created virtually using the algorithm, which at least partially correspond to the first part LA1 and the second part LA2 of the hole arrangement LA. In the present case, the drill hole template hole arrangement LAT of the first drill hole template S1 comprises only a part of three drill holes of the first part LA1 and the drill hole template hole arrangement LA2 ‘of the second drill hole template S2 only a part of four drill holes of the second part LA2. The reason for this may be that not all the holes of the osteosynthesis device OP should be used for screwing or that only some of the drill holes should be pre-drilled, where the remaining drill holes should be drilled to the two bone fragments K1 after partial fastening of the osteosynthesis device OP intraoperatively using the osteosynthesis device OP as a template , K2 are to be formed.

In other cases, not shown, the hole arrangements LA1 and LAT or LA2 and LA2 ‘can of course be identical.

The data of the two borehole templates S1, S2 are created in such a way that the two borehole templates S1, S2 have a respective mechanical indicator device KOI, K02, which clearly, ie a tolerance-free or low-tolerance, positioning of the two borehole templates S1, S2 on the associated first or second bone fragment K1, K2 according to the drill holes to be formed.

In other words, the indicator device KOI, K02 is intended to avoid incorrect positioning of the first and second drill hole templates S1, S2 on the associated first and second bone fragments K1, K2, respectively.

The mechanical indicator device is shown in more detail in FIG. 1 f) in a vertical cross section through the first bone fragment K1. In particular, the bone fragment K1 has a specific anatomical shape. The two drilling templates S1, S2 are therefore designed in such a way that they can be positioned on the associated bone fragment K1, K2 in an anatomically adapted manner, thereby avoiding incorrect positioning. This is possible in particular because each bone fragment K1, K2 has specific anatomical irregularities which, when creating the data for the drill hole templates S1, S2 can be taken into account. Examples of this are diameter variations or curvatures or surface irregularities or unevenness.

The virtual data of the first and second drilling templates S1, S2, which are obtained according to FIGS. 1e) and 1f), can then be used to produce the two drilling templates S1, S2, for example by making a respective drill hole template S1, S2 made of plastic or metal by means of a corresponding automated manufacturing device, for example a milling device, a three-dimensional printer, or the like.

In the context of extensive automation, it is possible to output these data from the two borehole templates S1, S2 directly to a corresponding automated production device 70 (cf. FIG. 3).

On the other hand, it is also possible to output the data of the two borehole templates S1, S2 graphically and to produce the borehole templates S1, S2 on the basis of corresponding graphic representations.

As shown in FIG. 1g) and in method step S6 of FIG. 2, the bone fragments K1, K2 are operated on using the two drill hole templates S1, S2 that have been produced in the meantime. For this purpose, the first drill hole template S1 is positioned clearly on the first bone fragment K1 using the mechanical indicator device KOI, and then the drill holes BL are drilled into the first bone fragment K1 at the correct location through the hole arrangement LA1 ‘.

Likewise, the second drill hole template S2 is clearly positioned on the second bone fragment K2 using the mechanical indicator device K02, and then the drill holes BL are drilled into the second bone fragment K2 using the second drill hole template S2. The two drill hole templates S1, S2 are then removed again.

Finally, with reference to FIGS. 1h) and 1i), the intraoperative fixing of the osteosynthesis device OP, here the osteosynthesis plate, takes place by means of fixing screws FS in the drill holes BL previously formed using the drill hole templates S1, S2.

In the present case, the first bone fragment K1 is first connected to the first part LA1 of the hole arrangement LA of the osteosynthesis device OP. In particular, this can be done in the non-repositioned state. Then the second bone fragment K2 is connected to the second part LA2 of the hole arrangement LA of the osteosynthesis device OP, which finally leads to the final state of the surgical intervention shown in FIG predrilled holes results.

The bone fragment-specific drill hole templates S1, S2 make it possible to dispense with repositioning before the start of the fixation of the osteosynthesis device OP, which makes a major contribution to avoiding postoperative misalignments.

3 shows a block diagram to explain a device for creating a bone fragment-specific drill hole template set for forming drill holes for a perforated osteosynthesis device according to a second embodiment of the present invention.

In Fig. 3 the essential components of the device for creating a bone fragment-specific drill hole template set for forming drill holes for a perforated osteosynthesis device according to the second embodiment are shown.

Reference numeral 10 denotes a central, correspondingly programmed processing device, which is connected to an image data input device 20 and a display device 30, for example a monitor. Reference number 40 denotes a manual graphic input device, e.g. a keyboard and / or mouse, reference number 60 a database and reference number 50 an output device, which can optionally be connected directly to a production device 70 for the drilling templates S1, S2, e.g. a three-dimensional printer.

In particular, the input of the image data for the pictorial representation according to FIG. 1a) takes place via the image data input device 20. This image data input device 20 can either be an X-ray structure analyzer or an interface for inputting digital X-ray structure analysis data or computer tomography data that have already been obtained elsewhere.

The formation and display of the repositioned arrangement of the two bone fragments K1, K2 for reconstructing the intact shape of the bone K is carried out by the processing device 10. This can either be done automatically by the predetermined Algorithm using a statistical model that is stored in the database 60, or by manual repositioning of the two bone fragments K1, K2 by the operator using the input device 40, for example a keyboard and a mouse.

The selection of the perforated osteosynthesis device OP to be used and the virtual arrangement of this osteosynthesis device P on the repositioned arrangement of the two bone fragments K1, K2, which are displayed on the display device 30, then also take place automatically or using the manual input device 40.

Furthermore, using the processing device 10, the at least partially virtual mapping of the hole arrangement LA of the selected perforated osteosynthesis device OP on the repositioned arrangement of the two bone fragments K1, K2 takes place, which is shown on the display device according to FIG. 1d).

The processing device 10 then generates the data of the two drilling templates S1, S2 with the respective hole arrangement LA1 ', LA2' automatically or after a corresponding user input, with the respective indicator device KOI, K02, which is the unambiguous Bone fragment-specific positioning of the drill hole templates S1, S2 on the two bone fragments K1, K2 in accordance with the drill holes BL to be formed.

4 shows a schematic cross-sectional illustration to explain a bone fragment-specific drill hole template set for forming drill holes for a perforated osteosynthesis device according to a third embodiment of the present invention.

4 shows a further first borehole template S1a and second borehole template S2a, which differ from the above-described borehole templates S1, S2 in terms of their structural design, e.g. the borehole template-hole arrangements LA1a, LA2a, but using the same method as in FIG Fig. 1a) -1e) explained, have been produced.

In particular, the first drill hole template S1a and the second drill hole template S2a have an extension as a distance indicator K01a, K02a, which can be positioned at one end of the associated bone fragment K1, K2 and which therefore shows the distance between the first drill hole template S1a and the second drill hole template S2a from the end of the associated Specifies bone fragments K1, K2, so that an unambiguous positioning of the two drill hole templates S1 a, S2a during the operation by the surgeon is also possible. In particular, the drill hole templates S1a, S2a can additionally have hook-shaped attachments HA1, HA2 for insertion into the fracture gap SP.

The anatomically adapted shape according to the first embodiment can either be retained or at least partially or completely reduced, which can reduce the effort required for setting the first and second drill hole templates S1a, S2a in practice.

5a) -e) are schematic cross-sectional representations of a course of supply of a bone fracture to explain a method for creating a bone fragment-specific drill hole template set for forming drill holes for a perforated osteosynthesis device according to a fourth embodiment of the present invention.

With reference to Fig. 5a) and method step S1 in Fig. 2, a pictorial representation, for example a computed tomography or X-ray representation, of a bone fracture of a bone K belonging to a human extremity, for example a leg or an arm, is shown. The bone K ‘is split by the bone fracture into a first bone fragment K1‘ and a second bone fragment K2 ‘, between which a fracture gap SP‘ extends. In particular, the bone K ‘has a ball joint KU at its proximal end 1. The distal end of the bone K ‘is denoted by reference number 2.

The pictorial representation, which was created here for example by means of two-dimensional or three-dimensional X-ray structure analysis data, is shown on a display device 30, for example a monitor (cf. FIG. 3).

Further with reference to FIG. 5b) and method step S2 in FIG. 2, a virtual formation and display of a reduced arrangement of the first and second bone fragments K1 ', K2' for reconstructing an axially correct, intact shape of the bone K is carried out using the graphic display. In this case, the first and second bone fragments K1 ', K2' are repositioned in the intact form on the display device 30 either using a manual input device 40 (cf. FIG. 3), or this is done by means of a predetermined algorithm using a predetermined statistical model for the intact shape of the bone K 'after a corresponding user input. The repositioned The arrangement of the bone fragments K1 K2 'is thus shown virtually on the display device 30 (FIG. 3).

In particular, the repositioning includes translational and rotational movements of the two bone fragments K1 ‘, K2‘ due to the ball joint KU. In the case of more complicated comminuted fractures, further bone fragments (not shown) can also be included in the reduction and the following steps.

When using a given statistical model, the associated surface properties of the bone K ‘can be improved. This is particularly useful for fractures with loss of substance.

In a further step, which is shown in FIG. 5c) or method step S3 in FIG. 2, a perforated osteosynthesis device ON to be used to fix the first and second bone fragments K1 ', K2' in the form of an intramedullary nail with a is then selected Hole arrangement LA 'with at least partially oblique holes through the intramedullary nail which extends through the two bone fragments K1', K2 '.

The correctly arranged osteosynthesis device ON is shown in the position in which it should be after an operation to be carried out later. The selection takes place either manually or automatically using a database 60 (cf. FIG. 3) in which a plurality of predetermined osteosynthesis devices with corresponding hole arrangements is stored. After the final position has been determined, a first part of the arrangement of holes LA is located within the first bone fragment K1 and a second part of the arrangement of holes LA ‘is located within the second bone fragment K2.

As shown in FIG. 5d) and method step S4 in FIG. 2, the hole arrangement LA 'is then at least partially mapped onto the repositioned arrangement of the two bone fragments KT, K2' using a corresponding algorithm by a corresponding projection and on the display device 30 (see. Fig. 3) shown. For the projection, vectors 4 are first generated through the holes of the hole arrangement LA ‘, the intersection points of which are mapped with the surface of the bone K‘.

The hole arrangement LA 'thus has a first part LA'1, which is located on the first bone fragment KT, and a second part LA'2, which is located on the second bone fragment K2'. Although in the present case the entire arrangement of holes LA 'is mapped onto the repositioned arrangement of the two bone fragments K1', K2 ', this must be done not necessarily so, but in certain cases it may also be sufficient to virtually map only part of the hole arrangement LA 'on the repositioned arrangement of the two bone fragments K1', K2 ', for example if not all holes of the hole arrangement LA' for the introduction of fixation devices during to be used later during the operation or a few holes already ensure correct intraoperative alignment of the ON osteosynthesis device.

In a further step with reference to FIG. 5e) and method step S5 in FIG. 2, data from a first drilling template S1 'and a second drilling template S2' with a respective drilling template-hole arrangement LA'1a, LA'2a are virtually using the Algorithm created which at least partially correspond to the first or second part LA'1, LA'2. In the present case, the drill hole template-hole arrangement LA'1a of the first drill hole template ST comprises only a part of four drill holes of the first part LA'1 and the drill hole template-hole arrangement LA'2a of the second drill hole template S2 'only a part of four drill holes of the second Partly LA'2. The background to this may be that not all the holes of the ON osteosynthesis device should be used for screwing or that only some of the drill holes should be pre-drilled, where the remaining drill holes should be drilled to the two bone fragments KT intraoperatively after partial fastening of the ON osteosynthesis device using the ON osteosynthesis device as a template , K2 'are to be formed.

In other cases, not shown, the hole arrangements LA‘1 and LA‘1a or LA‘2 and LA‘2a can of course be identical.

The data of the two borehole templates S1 ', S2' are created in such a way that the two borehole templates ST, S2 'have a respective mechanical indicator device KOT, K02' which clearly, ie tolerance-free or low-tolerance, positioning of the two borehole templates ST, S2 'on the associated first or second bone fragment KT, K2' in accordance with the drill holes to be formed.

In this embodiment, each bone fragment KT, K2 ‘has specific anatomical irregularities which are taken into account when creating the data for the borehole templates S1, S2. In particular, these are diameter variations or curvatures or surface irregularities or unevenness.

The virtual data of the first and second drilling templates ST, S2 ', which are obtained in accordance with FIG. 5e), can then be used to position the two drilling templates ST, S2' use, for example by creating a respective drill hole template S1 ', S2' made of plastic or metal by means of a corresponding automated manufacturing device, for example a milling device, a three-dimensional printer, or the like.

The further steps proceed analogously to the first embodiment, which were described with reference to FIGS. 1g) to 1i), the osteosynthesis device ON if necessary after the drilling holes have been formed using the two drilling templates S1 ', S2' and after insertion into the Bone K 'can still be aligned within the bone K' with the aid of a guide trocar or a similar aid with respect to the drill holes formed in the bone K 'or additional drill holes can be produced. The latter can preferably take place starting from the distal end 2 of the bone K ‘.

Although the present invention has been explained above on the basis of preferred exemplary embodiments, it is not restricted thereto, but rather can be modified in many ways.

In particular, the present invention can be used for any perforated osteosynthesis devices which can be fixed to the bone by means of fixing devices.

The invention is also not limited to the examples shown with large tubular bones, but can be used generally for any bones or bone fragments.

The drill hole templates also do not have to be designed to be suitable in each case for a single bone fragment; rather, a single drill hole template can also be used for a plurality of bone fragments. This depends on the specific fracture-specific situation presented to the surgeon or user. Several drill hole templates can also be used for a single bone fragment.

Although in the above embodiments the respective indicator device is designed as a mechanical indicator device on the first or second drill hole template, an optical indicator device can alternatively or additionally be implemented, e.g. in the form of one or more optical markers according to geometric or other special features of the bone fragments.

Claims

1. Method for creating a bone fragment-specific drill hole template set for creating drill holes for a perforated osteosynthesis device (OP; ON) with the following steps:

Creating a pictorial representation of at least a first and a second bone fragment (K1, K2; K1 ‘, K2‘) of a fracture of a bone (K; K ‘); virtually forming and displaying a reduced arrangement of the first and second bone fragments (K1, K2; K1 ‘, K2‘) for reconstructing an intact shape of the bone (K; K ‘) using the pictorial representation;

Selecting a perforated osteosynthesis device (OP; ON) to be used with a hole arrangement (LA; LA ‘) for mutual fixation of the first and second bone fragments (K1, K2; K1‘, K2 ‘) in the repositioned arrangement; virtually arranging the selected perforated osteosynthesis device (OP; ON) to be used on the reduced arrangement of the first and second bone fragments (K1, K2; K1 ‘, K2‘) using the pictorial representation; at least partial virtual mapping of the arrangement of holes (LA; LA ') of the selected perforated osteosynthesis device (OP; ON) to be used on the repositioned arrangement of the first and second bone fragments (K1, K2; K1', K2 ') using the pictorial representation, wherein a first part (LA1; LA'1) of the hole arrangement (LA; LA ') on the first bone fragment (K1; K1') and a second part (LA2; LA'2) of the hole arrangement (LA; LA ') on the second bone fragment (K2; K2 ') is imaged;

Creation of data for a first drill hole template (S1; ST; S1 a) with a first drill template hole arrangement (LAT; LA'1a; LA1a), which at least partially corresponds to the first part (LA1; LA'1), for the formation of drill holes ( BL) on the first bone fragment (K1; KT);

Creation of data for a second drill hole template (S2; S2 '; S2a) with a second drill template-hole arrangement (LA2';LA'2a; LA2a), which at least partially corresponds to the second part (LA2; LA'2), for forming drill holes (BL) on the second bone fragment (K2; K2 '); wherein the data of the first and second borehole template (S1, S2; S1 S2 '; S1 a, S2a) are created in such a way that they have a respective associated mechanical and / or optical indicator device (K01, K02; K01', K02 '; K01a, K02a), which have a low-tolerance or tolerance-free positioning of the first and second drill hole template (S1, S2; S1 ', S2'; S1a, S2a) on the first and second bone fragments (K1, K2; K1 ', K2') according to the forming drill holes (BL) allows.

2. The method according to claim 1, wherein the data are created in such a way that the first and / or second borehole template (S1, S2; S1 ', S2'; S1a, S2a) has an optical indicator device, in particular in the form of one or more optical ones Markers corresponding to geometric or other peculiarities of the associated bone fragment (K1, K2;

K1 ‘, K2‘).

3. The method according to claim 1 or 2, wherein the data are created in such a way that the first and / or second borehole template (S1, S2; S1 ', S2'; S1a, S2a) an indicator device (K01, K02; K01 ', K02 '; K01a, K02a) in the form of a contour (K01, K02; K01', K02 ') of the respective drill hole template (S1, S2; S1', S2 '), which is attached to the associated bone fragment (K1, K2; K1', K2 ') can be positioned in an anatomically adapted manner.

4. The method according to claim 1, 2 or 3, wherein the data are created in such a way that the first and / or second borehole template (S1, S2; S1 ', S2'; S1a, S2a) an indicator device (K01a, K02a) in the form a distance indicator (K01a, K02a) of the respective drill hole template (S1a, S2a) which can be positioned at one end of the associated bone fragment (K1, K2).

5. The method according to any one of the preceding claims, wherein the selection of a perforated osteosynthesis device (OP; ON) to be used takes place manually or automatically from a database (60).

6. The method according to any one of the preceding claims, wherein the creation of the pictorial representation takes place by means of two- or three-dimensional X-ray structure analysis data.

7. The method according to any one of the preceding claims, wherein the virtual formation and display of the repositioned arrangement of the bone fragments (K1, K2; K1 ', K2') takes place using a predetermined statistical model.

8. The method according to any one of the preceding claims, wherein the virtual formation and display of the repositioned arrangement of the bone fragments (K1, K2; K1 ‘, K2‘) takes place manually using a graphic input device.

9. The method according to any one of the preceding claims, wherein the data of the borehole templates (S1, S2; S1 ', S2'; S1 a, S2a) to a manufacturing device (70) for manufacturing the borehole templates (S1, S2; S1 ', S2' ; S1a, S2a), in particular a milling device or a three-dimensional printer.

10. The method according to any one of the preceding claims, wherein the perforated osteosynthesis device (OP; ON) is an osteosynthesis plate or an intramedullary nail.

11. Device for creating a bone fragment-specific drill hole template set for creating drill holes for a perforated osteosynthesis device (OP; ON), comprising: an image creation device (10, 20, 30) for creating a pictorial representation of a first and a second bone fragment (K1, K2; K1 ', K2 ') a fracture of a bone (K; K'); a processing device (10) for virtually forming and displaying a reduced arrangement of the first and second bone fragments (K1, K2; K1 ', K2') for reconstructing an intact shape of the bone (K; K ') using the pictorial representation; an input device (40) for selecting a perforated osteosynthesis device (OP; ON) to be used with a hole arrangement (LA; LA ') for mutual fixation of the first and second bone fragments (K1, K2; K1', K2 ') in the repositioned arrangement and for virtually arranging the selected perforated osteosynthesis device (OP; ON) to be used on the repositioned arrangement of the bone fragments (K1, K2) using the pictorial representation; wherein the processing device (10) is set up for: at least partial virtual mapping of the hole arrangement (LA; LA ') of the arranged selected perforated osteosynthesis device (OP; ON) to be used on the repositioned arrangement of the first and second bone fragments (K1, K2; K1') , K2 ') using the pictorial representation, a first part (LA1; LA'1) of the hole arrangement (LA; LA ') on the first bone fragment (K1; K1') and a second part (LA2; LA'2) of the hole arrangement (LA; LA ') on the second bone fragment (K2; K2') can be displayed;

Creation of data for a first drill hole template (S1; ST; S1 a) with a first drill template hole arrangement (LA1 '; LA'1a; LA1a), which at least partially corresponds to the first part (LA1; LA'1), for forming drill holes (BL) on the first bone fragment (K1; KT);

Creation of data for a second drill hole template (S2; S2 '; S2a) with a second drill template-hole arrangement (LA2'; LA'2a; LA2a), which at least partially corresponds to the second part (LA2; LA'2), for forming drill holes (BL) on the second bone fragment (K2; K2 '); wherein the data of the first and second borehole template (S1, S2; S1 ', S2'; S1 a, S2a) can be created in such a way that they have a respective associated mechanical and / or optical indicator device (KOI, K02; KOT, K02 '; K01a , K02a), which have a low-tolerance or tolerance-free positioning of the first and second drill hole template (S1, S2; ST, S2 '; S1a, S2a) on the first and second bone fragment (K1, K2; KT, K2') according to the Drill holes (BL) made possible.

12. The device according to claim 11, further comprising a database (60) for storing a plurality of osteosynthesis devices (OP; ON) from which the perforated osteosynthesis device (OP; ON) to be used can be selected manually or automatically.

13. The device according to claim 12, wherein a predetermined statistical model for the virtual formation and display of the repositioned arrangement of the bone fragments (K1, K2; KT, K2 ‘) is stored in the database (60).

14. The device according to claim 11, 12 or 13, further comprising an output device (50) for outputting the data of the borehole templates (S1, S2; ST, S2 '; S1a, S2a) to a production device (70) for producing the borehole templates (S1 , S2; ST, S2 '), in particular a milling device or a three-dimensional printer.

15. Borehole template set for forming boreholes for a perforated osteosynthesis device (OP; ON), in particular produced according to the method according to one of claims 1 to 10, with: a first drill hole template (S1; S1 S1a) with a first drill template-hole arrangement (LA1 ';LA'1a; LA1a) which at least partially a first part (LA1; LA'1) of a hole arrangement (LA; LA') of the osteosynthesis device ( OP; ON) corresponds to the formation of boreholes (BL) on a first bone fragment (K1; K1 '); a second drill hole template (S2; S2 '; S2a) with a second drill template hole arrangement (LA2';LA'2a; LA2a) which at least partially has a second part (LA2; LA'2) of the hole arrangement (LA; LA ') of the Osteosynthesis device (OP; ON) corresponds to the formation of boreholes (BL) on a second bone fragment (K2; K2 '); wherein the first and second borehole templates (S1, S2; ST, S2 '; S1a, S2a) are created in such a way that they have a respective associated mechanical and / or optical indicator device (KOI, K02; KOT, K02'; K01a, K02a), which allows for low-tolerance or tolerance-free positioning of the first and second drill hole templates (S1, S2; S1 ', S2'; S1 a, S2a) on the first and second bone fragments (K1, K2; KT, K2 ') in accordance with the drill holes to be formed (BL ) allows.

16. Borehole template set according to claim 15, wherein the first and / or second borehole template (S1, S2; ST, S2 '; S1a, S2a) has an optical indicator device, in particular in the form of one or more optical markers corresponding to geometric or other features of the associated Bone fragment (K1, K2;

KT, K2 ‘).

17. Borehole template set according to claim 15 or 16, wherein the first and / or second borehole template (S1, S2; ST, S2 '; S1a, S2a) an indicator device (KOI, K02; KOT, K02'; K01a, K02a) in the form of a Contour (KOI, K02; KOT, K02 ') of the respective drill hole template (S1, S2; ST, S2'), which can be positioned on the associated bone fragment (K1, K2; KT, K2 ') in an anatomically adapted manner.

18. Borehole template set according to claim 15, 16 or 17, wherein the first and / or second borehole template (S1, S2; ST, S2 '; S1a, S2a) an indicator device (KOI, K02; KOT, K02'; K01a, K02a) in In the form of a distance indicator (KOT, K02 ') of the respective drill hole template (S1, S2; ST, S2'), which can be positioned at one end of the associated bone fragment (K1, K2; KT, K2 ').