Machinable molded body with bone material

Description

Field of the invention

[0001] The invention relates to an arrangement comprising a plurality of natural and / or artificial prosthetic elements, such as autogenous, isogenic, xenogenic, or allogenic bone pieces, which can be inserted into a human or animal body, with a shaped body having a substrate, wherein the substrate contains the prosthetic elements partially or substantially completely and consists of a material which can be machined with a tool and which can be converted from a flowable state, in which the substrate can be connected to the prosthetic elements or the prosthetic elements can be introduced into the substrate, into a solid state. Furthermore, the invention relates to a method for introducing a plurality of natural and / or artificial prosthetic elements, such as autogenous, isogenic, xenogenic, or allogenic bone pieces, which can be inserted into a human or animal body, into such an arrangement.Furthermore, the invention relates to a device for processing natural and / or artificial prosthetic elements that can be inserted into a human or animal body, such as autogenous, isogenic, xenogenic or allogenic bone pieces, using an arrangement of the aforementioned type. Finally, the invention relates to a method for processing natural and / or artificial prosthetic elements that can be inserted into a human or animal body, such as autogenous, isogenic, xenogenic or allogenic bone pieces, using such a device and an arrangement of the aforementioned type. Background of the invention

[0002] The use of prosthetic elements made of artificial materials, such as metal, ceramic, or plastic, has proven effective in practice. However, there are also situations in which the use of prosthetic elements made of natural materials, such as autogenous, isogenic, xenogenic, or allogenic bone fragments, is advantageous. This is the case, for example, when purely ceramic materials are too brittle to be transferred into complex geometries and secured to the defect site with lag screws. Natural bone material is not brittle but retains its natural ductility at the defect site, which significantly facilitates handling, shaping, and fixation.

[0003] The combination of modern three-dimensional imaging techniques and industrial CAD / CAM technology leads to improved planning and treatment methods for all types of prostheses in general, and in oral and maxillofacial surgery in particular. A three-dimensional model is generated from the data generated by the imaging process, which usually contains a large number of individual cross-sectional images, using suitable software. Pre-contouring bone blocks, especially allogeneic ones, on the model then opens up the possibility of maximizing the accuracy of fit prior to surgery, thus shortening the actual duration of the procedure. By using suitable processing equipment, such as CNC milling machines, geometrically sophisticated, customized prostheses and transplants can be manufactured from the prepared raw material. This also applies in particular to dental implants.When using natural bone material, it is recommended to remove as much cortical bone as possible. The finished prosthetic elements are packaged and sterilized after processing.

[0004] US 2007 / 0233272 A1, which constitutes the closest prior art from which the present invention is based, discloses an arrangement comprising a plurality of natural and / or artificial prosthetic elements in the form of reinforcing structural elements that can be inserted into a human or animal body, with a molded body having a substrate, wherein the substrate contains the prosthetic elements partially or substantially completely. The substrate consists of a material that can be machined with a tool, which has a biocompatible binder and can be converted from a flowable state, in which the prosthetic elements can be introduced into the substrate, into a solid state through a setting process. The binder comprises cement and contains alloplastic, autogenous, isogenic, allogenic, or xenogenic bone substitutes. Summary of the invention

[0005] It is now an object of the present invention to provide a simple and at the same time optimal solution for storing such prosthetic elements and for processing them.

[0006] This object is achieved according to a first aspect of the present invention with an arrangement comprising a plurality of natural and / or artificial prosthetic elements, such as autogenous, isogenic, xenogenic or allogenic bone pieces, which can be inserted into a human or animal body, with a shaped body which has a substrate, wherein the substrate contains the prosthetic elements in sections or substantially completely and consists of a material which can be machined with a tool, wherein the material of the substrate can be converted from a flowable state, in which the substrate can be connected to the prosthetic elements or the prosthetic elements can be introduced into the substrate, into a solid state, characterized in that the material of the substrate is in the flowable state when the temperature acting on the material has a first temperature value and assumes a solid state,if the temperature acting on the material of the substrate has a second temperature value which is below the first temperature value.

[0007] Accordingly, the invention proposes providing a machinable molded body with prosthetic elements that are connected to one another by means of a substrate to form the molded body. The term "prosthetic elements" within the meaning of the present invention includes all types of blanks, material blocks, prefabricated semi-finished products, and / or prostheses or transplants that are already substantially finished for use in human or animal bodies, including, among others, dental implants. The prosthetic elements comprise artificial material and / or natural material, such as autogenous, isogenic, xenogenic, or allogenic bone fragments, or consist of such materials. The prosthetic elements are preferably semi-finished products for producing prostheses or transplants that are then inserted into a human or animal body.By combining the prosthetic elements into a molded body using the substrate, a simple yet optimal way to store and archive the prosthetic elements is created. Furthermore, the arrangement according to the invention not only enables simple storage of a plurality of prosthetic elements in a common arrangement, but also their easy transport.

[0008] Since the substrate used according to the invention, by which the individual prosthetic elements are connected to one another to form the molded body, consists of a material that can be machined with a tool, the prosthetic elements for the formation of transplants and prostheses and for their subsequent use in a human or animal body can be easily machined or separated from the molded body using a machining device. For this purpose, the molded body according to the invention can be used as a fixing aid for fastening or clamping the arrangement of the prosthetic elements to the holding device of a machining device and can thereby form a type of safety buffer, thereby avoiding, on the one hand, damage to the holding device by the tool of the machining device and, on the other hand, spatial restrictions when machining a desired prosthetic element from the molded body.Handling is particularly simple because the material of the substrate can be converted from a flowable state, in which the substrate can be connected to the prosthetic elements or the prosthetic elements can be inserted into the substrate, into a solid state.

[0009] Finally, the arrangement according to the invention is characterized in that the material of the substrate is in a flowable state when the temperature acting on the material has a first temperature value, and assumes a solid state when the temperature acting on the material of the substrate has a second temperature value below the first temperature value. Accordingly, according to the invention, the connection of the prosthetic elements to form the molded body is not achieved via a binding agent formed by the substrate with the aid of a setting process, but rather by changing the aggregate state of the substrate from "flowable" to "solid."

[0010] Preferred embodiments and further developments of the arrangement according to the first aspect of the invention are specified in the dependent claims 2 to 5.

[0011] Preferably, the first temperature value at which the substrate is flowable is above room temperature and the second temperature value at which the substrate is in the solid state corresponds substantially to room temperature.

[0012] Alternatively, the substrate can also be made of a material such that the first temperature value essentially corresponds to room temperature and the second temperature value is below room temperature. Preferably, the second temperature value is below 0°C, at which the substrate freezes, thereby forming the molded body into a kind of ice block. In this case, the substrate material is expediently water or an isotonic saline solution.

[0013] According to a further preferred embodiment, a temperature holding device is provided which is designed to keep the shaped body at the second temperature value and preferably comprises coolant.

[0014] The above-mentioned object is further achieved according to a second aspect of the present invention with a method for introducing a plurality of natural and / or artificial prosthetic elements, such as autogenous, isogenic, xenogenic or allogenic bone pieces, which can be inserted into a human or animal body, into an arrangement according to the first aspect, which arrangement comprises a shaped body and a substrate, wherein the substrate is designed to contain the prosthetic elements in sections or substantially completely, characterized in that I) the temperature acting on the material of the substrate (4a) is brought to a first temperature value at which the material is in a flowable state, II) the prosthetic elements (2, 12) are introduced into the substrate (4a) and III) subsequently the temperature acting on the material of the substrate (4a) is brought to a second temperature value below the first temperature value at which the material assumes a solid state, wherein preferably in step II the prosthetic elements (2, 12) are placed in a mold and then the substrate (4a) is filled into the mold in the flowable state.

[0015] Furthermore, the above-mentioned object is achieved according to a third aspect of the present invention with a device for processing natural and / or artificial prosthetic elements that can be inserted into a human or animal body, such as autogenous, isogenic, xenogenic or allogenic bone pieces, using an arrangement according to the first aspect, wherein the device has a detection device for detecting the position of the prosthetic elements within the molded body and a processing device, and wherein the processing device has a tool for partially or completely separating prosthetic elements from the molded body.

[0016] The detection device allows the prosthetic elements within the molded body to be precisely identified. Taking this identification into account, the processing device is then able to use its tool to machine or separate the desired prosthetic element, either sectionally or completely, from the molded body, at least to a large extent precisely. This is generally only possible when the molded body is in its solid state.

[0017] Preferred embodiments and further developments of the device according to the third aspect of the invention are specified in the dependent claims 8 to 10.

[0018] Preferably, the detection device is also provided for detecting the temperature and / or the composition and / or the quality of the prosthetic elements. In this case, the detection device can be used to precisely determine not only the position but also the quality of the prosthetic elements enclosed in the molded body. This is particularly advantageous because it allows sections of the prosthetic elements to be machined from the molded body with the desired quality for a specific section or sections of the prosthesis to be manufactured. This applies in particular if the prosthetic elements contain or consist of pieces of bone.

[0019] Due to the result of the detection by the detection device, the production of prosthetic elements or prostheses can be carried out with particular precision, since the tool of the processing device can be guided precisely to the desired sections of the prosthetic elements.

[0020] The detection device preferably comprises an X-ray device and / or a computed tomography device and / or at least one temperature sensor. A computed tomography device in this sense refers not only to a conventional computed tomography (CT) scanner, but also to a digital volume tomography (DVT) scanner, which provides three-dimensional X-ray data suitable for virtual transplant planning.

[0021] Furthermore, a fixing device for clamping the molded body can be provided.

[0022] To produce an arrangement according to the first aspect by a casting process, a mold is preferably provided in which the prosthetic elements can be arranged and into which the substrate can be filled in the flowable state.

[0023] To produce an arrangement according to the first aspect using a substrate whose material changes its state of aggregation at different temperatures, a temperature-maintaining device is expediently provided for maintaining the temperature of the molded body at the second temperature value which is lower than the first temperature value, wherein the temperature-maintaining device preferably has a cooling device which cools the molded body to a second temperature value below room temperature, preferably below 0°C, whereby the molded body is transformed into a type of ice block.Finally, the above-mentioned object is achieved according to a fourth aspect of the present invention with a method for processing natural and / or artificial prosthetic elements that can be inserted into a human or animal body, such as autogenous, isogenic, xenogenic or allogenic bone pieces, using an arrangement according to the first aspect and a device according to the third aspect, wherein. A) at least the position of the prosthetic elements within the molded body is determined using the detection device, B) depending on at least the position of the prosthetic elements contained in the molded body detected by the detection device, the tool of the processing device is guided into the molded body to the prosthetic elements with the position detected by the detection device and C) the prosthetic element or elements with the position detected by the detection device are separated from the molded body using the tool of the processing device.

[0024] After this, the preform is placed or positioned in a, preferably already existing, detection device to determine the exact position of the prosthetic elements and, if necessary, also the respective quality of the prosthetic elements and / or, in the case of bone fragments being used as prosthetic elements, their density. For this purpose, the preform should preferably also be provided with an exact zero point reference, which expediently has defined markers. The data of the thus acquired preform can then be loaded into CAM software to nest the prosthetic elements, at least with their sections to be machined, at the desired position within the preform.This is because it is possible to nest the sections of the prosthetic elements to be carved out, or even the entire prosthetic elements to be carved out, in such a way that they only need to be positioned in the bone where they are to be inserted into the human or animal body. This allows for accurate nesting depending on bone density.

[0025] Preferred embodiments and further developments of the method according to the fourth aspect of the invention are specified in dependent claims 12 and 13.

[0026] It is advisable to clamp the molded body in a fixing device before step B.

[0027] A preferred further development of the above-mentioned method is characterized in that in step A the density of the prosthetic elements is further detected with the aid of the detection device.

[0028] A preferred embodiment of the invention is explained in more detail below with reference to the accompanying drawings. They show: Fig. 1 schematically shows in cross section an embedding blank in which a semi-finished bone product is embedded by way of example; Fig. 2 schematically shows in cross section sections of a fixing device of a processing device in which the embedding blank is Fig. 1 is clamped; Fig. 3 the same view as Fig. 2 , wherein a bone product defined within the bone semi-finished product for the processing or separation is additionally shown schematically; Fig. 4 schematically shows in perspective top view the fixing device of the processing device in which the embedding blank is clamped, wherein in the embedding blank the bone semi-finished product embedded therein with the bone product defined therein can also be seen schematically; Fig. 5 the same view as Fig. 3, with sections of the embedding blank and the semi-finished bone product embedded therein already removed to expose the bone product to be removed; and Fig. 6 a similar view to Fig. 4 , however, the bone product is also shown schematically in a state that is now essentially completely separated from the embedding blank and the bone semi-finished product shortly before removal from the embedding blank. Detailed description

[0029] In Fig. 11 shows a schematic cross-sectional view of a semi-finished bone product 2 embedded in an embedding blank 4, also alternatively referred to as a "blank," forming a shaped body. For the sake of completeness, it should be noted in this context that, in contrast to the exemplary illustrations in the figures, according to the invention, a plurality of semi-finished bone products 2 or similar prosthetic elements are incorporated into the embedding blank 4. The semi-finished bone product 2 can also be generally referred to as a prosthetic element and, in the present exemplary embodiment, can in particular comprise autogenous, isogenic, xenogenic, or allogenic bone pieces. However, it is also conceivable, alternatively or additionally, to use suitable artificial material for the semi-finished bone product 2. The embedding blank 4 has a substrate 4a, which consists of a material that can be machined with a tool and fixes the semi-finished bone product 2 within the embedding blank 4.

[0030] To transfer the bone semi-finished product 2 into the embedding blank 4, the material of the substrate 4a is initially in a flowable state, in which it is bonded to the bone semi-finished product 2 or the bone semi-finished product 2 is introduced into the substrate 4a. For this purpose, the bone semi-finished product 2 is preferably placed in a mold (not shown), into which the substrate 4a is subsequently poured in liquid form. To fix the bone semi-finished product 2 within the embedding blank 4, the substrate 4a is subsequently converted into a solid state.

[0031] For this purpose, a material must be selected for the substrate 4a that changes its state of aggregation depending on the temperature, being in a fluid state at a higher temperature and assuming a solid state at a lower temperature. The higher temperature can be above room temperature and the lower temperature can essentially correspond to room temperature. Alternatively, it is also conceivable for the higher temperature to essentially correspond to room temperature and the lower temperature to be below room temperature. In the latter case, it is also conceivable to select a material for the substrate 4a that enters the solid state at at least 0°C, for which purpose water or an isotonic saline solution can preferably be used as the material for the substrate 4a, so that the embedding blank 4 then forms a type of ice block.

[0032] Only when, as already mentioned, the embedding blank 4 with the semi-finished bone product 2 embedded therein is in a solid state, is the semi-finished bone product 2 fixed within the embedding blank 4. Only then is the embedding blank 4 with the semi-finished bone product 2 embedded therein in a state that allows storage or further processing of the embedding blank 4 with the semi-finished bone product 2 embedded therein.

[0033] In the illustrated embodiment, the embedding blank 4 is given the shape of a disc-shaped shaped body, the peripheral edge 4b ​​of which is provided with a peripheral flange-like projection 4ba, which ends at a distance from the two sides or surfaces of the embedding blank 4, so that the edge 4b ​​between the projection 4ba and the respective adjacent surface of the embedding blank 4 has an undercut or shoulder 4bb, as in particular Fig. 1 combined with Fig. 4 can be recognized.

[0034] For further processing, the embedding blank 4 is clamped into a processing device not shown in the figures, the fixing device 6 of which is in the Fig. 2 to 5 is shown in sections. In the illustrated embodiment, the fixing device 6 has an inwardly circumferential flange-like projection 6a, on the underside of which a clamping ring 8 is arranged. Between the circumferential flange-like projection 6a of the fixing device 6 and the clamping ring 8, the embedding blank 4 is clamped with the circumferential flange-like projection 4ba formed on its circumferential edge 4b, such as Fig. 2 can be recognized.

[0035] Furthermore, in the illustrated embodiment, cooling holes 10 are formed both within the circumferential flange-like projection 6a of the fixing device 6 and within the clamping ring 8, such as Fig. 2These cooling holes 10 are part of a temperature-maintaining device (not shown) for maintaining the temperature of the embedding blank 4 at the aforementioned lower temperature, particularly when the substrate 4a consists of a material that changes its state of aggregation in the aforementioned temperature range and solidifies at the lower temperature. This ensures that the embedding blank 4 with the semi-finished bone product 2 embedded therein remains in the solid state, which is necessary for subsequent processing.

[0036] For the subsequent processing of the embedding blank 4 and in particular of the semi-finished bone product 2 embedded therein, a detection device (not shown in the figures) is used, into which, for example, the embedding blank 4 can be arranged or placed in order to determine or localize the exact position and, if necessary, also the respective quality and also the density in that area of ​​the semi-finished bone product 2 from which a desired bone product is to be machined, as is shown for example in Figures 3 and 4sketched and designated by the reference symbol "12." For this purpose, the embedding blank 4 should preferably also be provided with an exact zero-point reference, which expediently has correspondingly defined markers; however, such a zero-point reference is not depicted in the figures. The data of the bone product 12 thus acquired can then be loaded into CAM software in order to locate the bone product 12 to be machined at the desired position within the semi-finished bone product 2 and the embedding blank 4 that accommodates it.

[0037] The desired bone product 12 thus identified is then separated from the semi-finished bone product 2 using a tool of the processing device (not shown in the figures). In order to maintain the properties of the desired bone product 12 as well as the underlying semi-finished bone product 2 during the processing process tolerably and to avoid negatively influencing them, the aforementioned detection device (not shown in the figures) can also be used accordingly during the processing process, or a measuring device can be implemented additionally, for example, using temperature and pressure sensors. Fig. 5 the intermediate result of a first processing step, after which in the view of Fig. 5An area has already been carved out or separated from the bone semi-finished product 2 and the embedding blank 4 below the bone product 12, creating a recess 14 in this area. A target-actual comparison with respect to the desired shape of the bone product 12 is then carried out using the aforementioned detection device or another measuring device, such as an imaging scanning system, and this comparison is recorded for quality assurance purposes.

[0038] In Fig. 6 The final result of the processing is schematically shown, according to which the desired bone product 12 is essentially completely surrounded by the recess 14 and is thus already in a state detached from the semi-finished bone product 2, so that the bone product 12 thus processed only needs to be removed and inserted at the desired location in the human or animal body.

Claims

1. Arrangement of a plurality of natural and / or artificial prosthetic elements (2, 12) that can be inserted into a human or animal body, such as autogenous, isogeneic, xenogeneic or allogeneic bone pieces, comprising a shaped body (4) that has a substrate (4a), the substrate (4a) containing the prosthetic elements (2, 12) in portions or substantially completely and consisting of a material that is machinable with a tool, wherein the material of the substrate (4a) can be converted from a free-flowing state, in which the substrate (4a) can be connected to the prosthetic elements (2, 12) or the prosthetic elements (2, 12) can be introduced into the substrate (4a), into a solid state, characterised in that the material of the substrate (4a) is in the free-flowing state when the temperature acting on the material has a first temperature value and assumes a solid state when the temperature acting on the material of the substrate (4a) has a second temperature value that is below the first temperature value.

2. Arrangement according to claim 1, characterised in that the first temperature value is above room temperature and the second temperature substantially corresponds to room temperature.

3. Arrangement according to claim 1, characterised in that the first temperature value substantially corresponds to room temperature and the second temperature value is below room temperature, wherein preferably the second temperature is below 0°C and the material of the substrate (4a) is preferably water or isotonic saline solution.

4. Arrangement according to one of the preceding claims, characterised by a temperature-maintaining device (10) designed to maintain the shaped body (4) at the second temperature value.

5. Arrangement according to claim 4, characterised in that the second temperature value is below 0°C and the temperature-maintaining device (10) comprises coolant.

6. Method for introducing a plurality of natural and / or artificial prosthetic elements (2, 12) that can be inserted into a human or animal body, such as autogenous, isogeneic, xenogeneic or allogeneic bone pieces, into an arrangement having a shaped body (4) and a substrate (4a), wherein the substrate is configured to contain the prosthetic elements (2, 12) in portions or substantially completely, characterised in that I) the temperature acting on the material of the substrate (4a) is brought to a first temperature value at which the material is in the free-flowing state, II) the prosthetic elements (2, 12) are introduced into the substrate (4a), and III) then the temperature acting on the material of the substrate (4a) is brought to a second temperature value that is below the first temperature value and at which the material assumes a solid state, wherein preferably, in step II, the prosthetic elements (2, 12) are placed in a mould and then the substrate (4a) is filled into the mould in the free-flowing state.

7. Apparatus for machining natural and / or artificial prosthetic elements (2, 12) that can be inserted into a human or animal body, such as autogenous, isogeneic, xenogeneic or allogeneic bone pieces, using an arrangement according to at least one of claims 1 to 5, wherein the apparatus has a detection device for detecting at least the position of the prosthetic elements (2, 12) inside the shaped body (4) and a machining apparatus, and wherein the machining apparatus has a tool for removing prosthetic elements (12) from the shaped body (4) in portions or completely.

8. Apparatus according to claim 7, characterised in that the detection device is additionally provided for detecting the temperature and / or composition and / or quality of the prosthetic elements (2, 12) and / or has an X-ray device and / or a computed tomography device and / or at least one temperature sensor and / or a fixing device (6, 8) is provided for clamping the shaped body (4).

9. Apparatus according to claim 7 or 8, characterised in that in order to produce an arrangement according to claim 2, a mould is provided in which the prosthetic elements (2, 12) can be arranged and into which the substrate can be filled in the free-flowing state.

10. Apparatus according to at least one of claims 7 to 9, characterised in that in order to produce an arrangement according to claim 5, a temperature-maintaining device (10) for maintaining the temperature of the shaped body (4) at the second temperature value is provided, wherein the temperature-maintaining device (10), in an arrangement in which the first temperature value substantially corresponds to room temperature and the second temperature value is below room temperature, preferably below 0°C, preferably has a cooling device which cools the shaped body to a second temperature value below room temperature, with preference below 0°C.

11. Method for machining natural and / or artificial prosthetic elements (2, 12) that can be inserted into a human or animal body, such as autogenous, isogeneic, xenogeneic or allogeneic bone pieces, using an arrangement according to at least one of claims 1 to 5 and an apparatus according to at least one of claims 7 to 10, wherein A) the detection device is used to determine at least the position of the prosthetic elements (2, 12) within the shaped body (4), B) depending on at least the position, detected by the detection device, of the prosthetic elements (2, 12) contained in the shaped body (4), the tool of the machining device is guided in the shaped body (4) to the prosthetic elements (2, 12) having the position detected by the detection device, and C) the prosthetic element (12) or the prosthetic elements having the position detected by the detection device is or are removed from the shaped body (4) using the tool of the machining device.

12. Method according to claim 11 using a fixing device (6, 8) to clamp the shaped body (4), characterised in that prior to step B, the shaped body (4) is clamped in the fixing device (6, 8).

13. Method according to claim 11 or 12, characterised in that in step A, the detection device is furthermore used to detect the density of the prosthetic elements (2, 12).