DE102017005036A1 - INDIVIDUAL BIOMATERIAL VESSEL FOR THE RECONSTRUCTION OF BONE DEFECTS - Google Patents

Abstract

The invention relates to a device for covering and / or reconstruction of a bone defect site, which has an underfillable with a particulate material cavity between the defect surface and the bone defect facing surface of the device, which forms an essay comprising a frame forming a 3-dimensional solid, and A membrane fixed thereon, each consisting of the same or different biomaterials and having a bone defect facing surface and a bone defect facing surface, the dimensions and 3 dimensional geometry of the frame being determined by the surface defect data obtained by a slice imaging technique and further processed using CAD-CAM technology. Another object of the invention is a method, an adapted frame and a system for producing the device according to the invention.

Description

BACKGROUND OF THE INVENTION

1. TECHNICAL AREA

• • einen einen Rahmen bildenden 3-dimensionalen Festkörper, und
• • eine darauf befestigte Membran,

welche beide jeweils aus demselben oder unterschiedlichen Biomaterialien bestehen und eine dem Knochendefekt abgewandte Oberfläche und eine dem Knochendefekt zugewandte Oberfläche aufweisen. Ein weiterer Gegenstand der Erfindung ist ein Verfahren, ein angepasster Rahmen und ein System zur Herstellung der erfindungsgemäßen Vorrichtung.The invention relates to a device for covering and / or reconstruction of a bone defect site comprising a cavity which can be filled with a particulate material between the defect surface and the bone defect facing surface of the device, which comprises an attachment

• A frame forming a 3-dimensional solid, and
• A membrane attached thereto,

which both each consist of the same or different biomaterials and have a surface facing away from the bone defect and a surface facing the bone defect. Another object of the invention is a method, an adapted frame and a system for producing the device according to the invention.

2. State of the art

There is a great need for biomaterials for replacement of bone tissue and as a lead structure for new bone growth, bone surgery in orthopedics, dentistry and other fields for the restoration of bony structures after age-related resorption or loss due to other causes such as tumor resection, tooth loss, trauma or others.

If the bone supply is insufficient, bone formation will be performed. This may be an elevation of the alveolar crest or a sinus floor elevation. Bone building uses either autologous bone from the same individual or foreign material. The foreign material may either be of natural origin (eg, donor bone) or artificially produced (eg, some hydroxyapatite products). Bone building can be either particulate or block, where the block can be angular or round or multi-shaped. In the case of a particulate bone structure, the body's own bone can be mixed with foreign material.

For example, the following technique is known for increasing the alveolar crest or large lateral deposits with sufficient height: A bone block from the same patient is milled out at a donor site (eg mandibular angle) or appropriate biomaterial is used and transplanted to the desired implantation site and either press-accurate Fixed without auxiliary material or with an osteosynthesis screw in the local bone. In the case of a second intervention, the screw is then removed if necessary and the relevant dental implant is inserted. It is also conceivable to insert a dental implant directly and completely in such a bone cylinder on one side.

Different materials can be used for bone formation. Either autologous bone or artificial biomaterial or purified natural biomaterial from xenogeneic or allogenic bone is used. Allogeneic bone material is widely used in orthopedics and traumatology, oral and maxillofacial surgery and plastic surgery, for filling bone defects in fractures, cysts, tumors and TEP operations, but also jaw shrinkage and embryonic malformations ( Matti H 1929 . Wolter D 1976 ). Also xenogenic materials are used here (eg Equin Biotek block).

It is known that particulate matter or blocks with pore system heal better than solid material, since massive material has to be tediously completely dismantled and rebuilt.

It is also known that in blocks with pore system, no complete replacement of the material trabeculae with new bone takes place, even if this material is basically resorbable. For these reasons, techniques that use mostly particulate material are superior to other techniques. However, since an increase in the alveolar ridge or large lateral deposits mechanical stabilization is necessary to use thin stable elements for this purpose, which enclose the particulate material. These techniques are summarized as shell techniques because the thin stabilizing barrier works like a shell.

• • Schalen eines allogene kortikalen Knochens, wobei der Knochen durch Fräsen notdürftig an den Defekt angepasst wird. Diese Technik ist sehr alt.
• • Schalen eines autologen kortikalen Knochens welcher vom selben Patienten entnommen wurde und beispielsweise aus dem Bereich des Kieferwinkels im Unterkiefer oder der Maxill entnommen wird ( Gellrich, N. C., U. Held, R. Schoen, T. Pailing, A. Schramm and K. H. Bormann (2007). ”Alveolar zygomatic buttress: A new donor site for limited preimplant augmentation procedures.” Journal of Oral & Maxillofacial Surgery 65(2): 275–280. ) ( Khoury, F. (2013). ”The bony lid approach in pre-implant and implant surgery: a prospective study.” Eur J Oral Implantol 6(4): 375–384 ).
• • Schalen aus nicht resorbierbarem Material (z. B. Titan-Netz, metallverstärkte PTFE-Membranen) welche durch Biegen an den Defekt manuell angepasst werden. Klassische Beispiele sind die Cytoplast-Membran, Goretex-Membran, Neoss-Membran, Tiolox-Membran.
• • Schalen aus Laktiden (Iglhaut-Technik/Sonic Weld System), welche durch Erhitzen formbar gemacht werden und manuell and en Defekt angepasst werden ( Iglhaut, G., F. Schwarz, M. Grundel, I. Mihatovic, J. Becker and H. Schliephake (2014). ”Shell technique using a rigid resorbable barrier system for localized alveolar ridge augmentation.” Clin Oral Implants Res 25(2): e149–154 ).

This shell technique can be done according to the prior art by the following long-known techniques:

• • Shells of an allogeneic cortical bone, whereby the bone is adapted to the defect by milling in a makeshift manner. This technique is very old.
• Shells of an autologous cortical bone taken from the same patient and taken, for example, from the region of the mandibular angle in the lower jaw or the maxilla ( Gellrich, NC, U. Held, R. Schoen, T. Pailing, A. Schramm and KH Bormann (2007). "Alveolar zygomatic buttress: A new donor site for limited preimplant augmentation procedures." Journal of Oral & Maxillofacial Surgery 65 (2): 275-280. ) ( Khoury, F. (2013). "The bony lid approach to pre-implant and implant surgery: a prospective study." Eur J Oral Implantol 6 (4): 375-384 ).
• • Trays made of non-resorbable material (eg titanium net, metal-reinforced PTFE membranes) which are manually adjusted by bending to the defect. Classic examples are the cytoplast membrane, Goretex membrane, Neoss membrane, Tiolox membrane.
• • Lactoid shells (Iglhaut technique / Sonic Weld System), which are made malleable by heating and manually adapted to the defect ( Iglhaut, G., F. Schwarz, M. Grundel, I. Mihatovic, J. Becker and H. Schliephake (2014). "Shell technique using a rigid resorbable barrier system for localized alveolar ridge augmentation." Clin Oral Implants Res 25 (2): e149-154 ).

A well-known problem is the lack of fit of these manually adjusted shells. In addition, the manual adjustment requires enormous time in the OP.

The European patent application EP 2 536 446 The company ReOss proposes a correspondingly individually adapted device, where surface data of a bone defect is generated from a slice imaging and the defect is virtually filled in a CAD program. From these data, a 3D data set for the production of a shell which is created for the application of the shell technique.

• 1. Titanmaterial muss entfernt werden, da es nicht resorbierbar ist.
• 2. Magnesium führt bei der Resorption zu Gasbildung, welches erheblich die Knochenheilung beeinträchtigt.
• 3. Beide Materialien müssen in einem aufwendigen speziellen 3D-Schweiss-CAM-System hergestellt werden und führen somit zu hohen Kosten.
• 4. Beide Systeme arbeiten mit einem Netz, das Löcher aufweist (Mesh), was eine zusätzliche Deckung mit einer Kollagenmembran erfordert, um ungünstigen Einwuchs von Bindegewebe anstelle von Knochen zu vermeiden.
• 5. Es kann schwer sein große Flächen mit einer Materialdicke von 0,1 mm additiv oder subtraktiv herzustellen.

The products actually implemented and implemented by ReOss include individual, customer-made perforated membranes (mesh lattices) made of metals using CAD-CAM technology. Here, surface data of the defect are generated from a slice imaging and the defect is virtually filled in a CAD program. From these data, a 3D data set for a shell made using the shell technique and used for printing a titanium mesh shell, which is welded by a laser sintering process of titanium particles in a 3D printing CAM system. Corresponding shells made of absorbable magnesium are being tested. However, these devices have a number of disadvantages:

• 1. Titanium material must be removed as it is not absorbable.
• 2. Magnesium causes gas formation on absorption, which significantly affects bone healing.
• 3. Both materials must be produced in a complex special 3D welding CAM system and thus lead to high costs.
• 4. Both systems work with a mesh that has holes (mesh), which requires additional collagen membrane coverage to prevent unfavorable connective tissue ingrowth instead of bone.
• 5. It can be difficult to produce large surfaces with a material thickness of 0.1 mm additive or subtractive.

3D Printing was originally developed by Chuck Hull in 1984 and is a special form of CAM technology. It's an additive process to make a three-dimensional, solid object from a digital model. For 3D printing, surface data, usually a .STL file, is used by the 3D printer to create an object by successively stacking layers of material. The print resolution (layer thickness and X-Y in-plane resolution) is defined either as dpi (dots per inch) or micrometers (μm). A typical layer thickness is about 100 μm. Certain printers (eg Objet Connex series and 3D Systems' ProJet series) can achieve layer thicknesses of up to 16 μm thin. The X-Y resolution of the 3D printer is about 50 to 100 μm. Among other applications, 3D printers are also used to print matrices and scaffolds in biomedicine.

Some resorbable polymers have already been used for bio-3D printing using commercial melt-jet technology (PJP). This includes the polymers poly (caprolactone) (PCL), poly (L-lactide) (PLLA) and poly (lactide-co-glycolide) (PLGA).

Saito, Eiji, et al., Journal of Tissue Engineering and Regenerative Medicine 7, no. 2 (2013): 99-111 describe 3D-printing skeletal structures for bone formation using PLLA and PLGA. A massive framework structure was printed as a potential bone substitute material. Both polymers, PLLA and PLGA, were printed on the basis of slice imaging and CAD-CAM planning with final surface data. In this case, bone growth promoting factor BMP7 and fibroblast cells were additionally applied to the scaffold and implanted subcutaneously in mice for 4-8 weeks.

Recently, the printing parameters for 3D printing with polycaprolactone (PCL) have also been optimized (eg Seyednejad, Hajar, et al., Functionalized Polyesters 7, no. 5 (2012): 87 .). Here, PCL with a molecular weight of about 79 kDa was successfully printed with a bio-3D printer "Bioscaffolder" (Envisiontec GmbH, Gladbeck, Germany) to a block-like framework structure. Molten polymer was pressed with PJP technique through a 23 Ga heat nozzle (temperature: 110 ° C) and with the usual layer-by-layer technique, analogous to a standard Ulimaker 2+ printer, with a protrusion speed of the table of 350 mm / min, printed.

The present invention was based on the object to provide an individually adapted device for covering and / or reconstruction of a bone defect site, which does not have the disadvantages of the prior art devices or only to a reduced extent.

BRIEF SUMMARY OF THE INVENTION

• • einen Rahmen bildenden 3-dimensionalen Festkörper, und
• • eine darauf befestigte Membran,

welche beide jeweils aus demselben oder unterschiedlichen Biomaterialien bestehen und eine dem Knochendefekt abgewandte Oberfläche und eine dem Knochendefekt zugewandte Oberfläche aufweisen, dadurch gekennzeichnet, dass die Abmessungen und 3-dimensionale Geometrie des Rahmens durch die Oberflächendaten des Knochendefektes, die mit Hilfe eines Schichtbildgebungsverfahrens gewonnen und mittels CAD-CAM-Technik weiterverarbeitet wurden, definiert sind.This object is achieved according to the invention by providing a device for covering and / or reconstructing a bone defect site, which has a cavity which can be filled with a particulate material between the defect surface and the bone defect facing surface of the device, which comprises an attachment

• • a frame-forming 3-dimensional solid, and
• A membrane attached thereto,

which both each consist of the same or different biomaterials and have a surface facing away from the bone defect and a surface facing the bone defect, characterized in that the dimensions and 3-dimensional geometry of the frame by the surface data of the bone defect obtained by means of a layer imaging method and means CAD-CAM technique were further processed.

• (a) Eingabe der durch ein Schichtbildgebungsverfahren ermittelten Oberflächendaten des Knochendefektes in eine Datenverarbeitungsanlage,
• (b) Weiterverarbeitung dieser Oberflächendaten mit einer CAD-Technik,
• (c) Steuerung einer additiven oder subtraktiven CAD-CAM-Fertigungseinheit mit den entsprechend weiterverarbeiteten Daten;
• (d) Erzeugen des Rahmens aus einem Biomaterial mit einer additiven oder subtraktiven CAD-CAM-Fertigungseinheit;
• (e) Befestigen einer Membran aus einem resorbierbaren Biomaterial auf dem nach (d) erhaltenen Rahmen.

A further subject matter of the invention is a method for producing an attachment for a device according to the invention for covering and / or reconstruction of a bone defect site, the method comprising the following steps:

• (a) inputting the surface defect data of the bone defect into a data processing equipment as determined by a layer-forming method;
• (b) further processing of this surface data with a CAD technique,
• (c) controlling an additive or subtractive CAD-CAM manufacturing unit with the corresponding further processed data;
• (d) generating the biomaterial frame with an additive or subtractive CAD-CAM manufacturing unit;
• (e) attaching a membrane of a resorbable biomaterial to the frame obtained according to (d).

The present invention also relates to a biomaterial consisting of a frame forming 3-dimensional solid body for producing a device according to one of claims 1 to 14, wherein its dimensions and 3-dimensional geometry by the surface data of a bone defect, using a layer imaging method and further processed using CAD technology.

• (I) eine Datenverarbeitungsanlage zur Eingabe der mittels eines Schichtbildgebungsverfahrens gewonnenen Oberflächendaten des Knochendefektes, auf welcher eine Software geladen ist, die diese Oberflächendaten mittels CAD-Technik weiterverarbeitet;
• (II) eine additiven oder subtraktiven CAD-CAM-Fertigungseinheit, die als Herstellungsmedium einen ausreichenden Vorrat an einem Biomaterial enthält und durch die in der Komponente (I) eingegebenen und weiterverarbeiteten Daten gesteuert wird;
• (III) eine Arbeitsebene, auf welcher der Aufsatz erzeugt wird;
• (IV) gegebenenfalls eine daran angeschlossene Verpackungseinheit, in welcher der in der Komponente (III) erzeugte Rahmen unter sterilen Bedingungen verpackt wird.

The invention further provides a system for producing a frame for a device according to the invention for covering and / or reconstruction of a bone defect site, the system comprising the following components:

• (I) a data processing system for inputting surface data of the bone defect obtained by a slice imaging method, on which a software is loaded, which further processes said surface data by CAD technique;
• (II) an additive or subtractive CAD-CAM manufacturing unit which contains as a production medium a sufficient supply of a biomaterial and is controlled by the data input and further processed in the component (I);
• (III) a work plane on which the essay is generated;
• (IV) optionally, a packaging unit connected thereto in which the frame produced in component (III) is packaged under sterile conditions.

The component (IV) can be integrated into the system according to the invention or else be spatially separated from it within the sphere of influence of the surgeon.

BRIEF DESCRIPTION OF THE DRAWING

1 shows a schematic representation of the preferred method for producing the polymer shell: the data of a layer imaging (eg CT or DVT) are converted into surface data of the defect in the context of the CAD process. Then the CAD reconstruction of the defect and the export of this surface data to the 3D-CAM printing of the frame. The area covered by the frame is closed with a membrane in a second step as described in the text.

DETAILED DESCRIPTION OF THE INVENTION

In accordance with this invention, a biomaterial shell is provided for use in a bone augmentation surgical technique having thin stabilization walls (shells) for improving bone healing of defects and / or osseointegration of implants. This consists essentially of a framework which is individually produced by means of 3D printing or a subtractive production technique from a resorbable biomaterial on the basis of surface data of the bone defect and about which in a second step, a resorbable membrane is fixed.

The term "device" as used above and below denotes a device suitable for covering and / or reconstruction of a bone defect site in the form of a shell of a bioabsorbable biomaterial consisting of a frame and a membrane attached thereto, wherein the dimensions of the frame are defined by the dimensions of a bone defect.

A preferred embodiment of the invention uses plastic-jet printing technology (PJP), wherein the plastic is usually supplied as a filament from a roll. In a 3D printer of this type (eg Ultimaker 2+), the attachment is printed by pulling the material out of the cartridge via delivery tubes through the pressure jets. The material is then sprayed in a thin stream through the pressure jets. The movement of the print jet is coordinated by the printing plate, which lowers after the creation of each layer, so that a new layer can be applied to the last one. Thus, step by step, the object is created in the form of a solid filament. This technique is 3D printing by means of molten materials and is also referred to as fused filament fabrication (FFF), melt stratification (eg FDM - fused deposition modeling).

Based on the layers described above, a 3D object is preferably constructed on a movable and / or heated platform. The printhead is a heated extruder that melts fed material (in wire or rod form). Depending on the model, either the nozzle itself and / or the underlying platform is moved. The speed of such a printer is adjusted to the time required for the material used for cooling and curing. Only when the underlying layer is solidified, the next level is applied. The quality of such a printer is dependent not only on the digital design but also on the precision of the movements, the fineness of the nozzles and the thermal properties of the material. By adding more extruders and colored materials, colored objects can be realized.

In an alternative method, such an absorbable frame can also be produced using another additive manufacturing technique, including other 3D printing techniques.

Overall, there are various techniques besides the described plastic jet printing technology (PJP) for 3D printing.

Similar to a "normal" paper printer, a 3D printer also needs a digital file which provides the information of the object to be printed.

While the paper printer uses a .doc or .txt file containing the text contents, the digital fabrication uses a file format that contains information about the 3D model of the bone defect. To be able to construct the object from a 3D model, however, it must first be cut (digitally) into individual 2-dimensional, horizontal slices (layers). Such a file format with the information of all individual layers is for example a .STL or .AMF file. Based on such a file, each current "3D printer" can build an object from the sum of the individual 2D layers.

Additive Manufacturing (AM) to German also Generative Manufacturing describes a multitude of technical processes that have been described by ASTM International, 2012 in English in the areas of photopolymerization, material jetting, binder jetting, material extrusion, powder bed fusion, sheet lamination or directed energy deposition were categorized. Some of these methods are very similar in principle and differ only by a few modifications.

More particularly, the present invention relates to such devices, methods, and systems that utilize 3D solid state filament plastic 3D printing (PJP) printers that perform 3D printing with heat from a solid filament from a supply roll (plastic jet printing technology (PJP ) 3D printer) can be generated. Here, the use of the polylactide (PLLA) or polyglycolide (PLGA) is particularly preferred since this is commercially established. In addition, all other materials can be used which are absorbable and can be produced by the said technique.

The invention also relates in particular to such additive techniques in which titanium or magnesium or other suitable materials are sintered in layers in a melt sintering process to form a three-dimensional framework in the sense of the invention. This is also possible for ceramics and other materials.

Another preferred embodiment is the use of a subtractive production technique. Here, for example, allogeneic or xenogenic bone, ceramics such as hydroxyapatite or tricalcium phosphate, magnesium or titanium, but also polymers such as PEEK as a block or rod of a CNC milling machine supplied or in such a milling machine Inserted in blocks and then the planned shape milled out in a CAD-CAM technique.

As a result, the frame is absorbable and does not need to be removed in another procedure. The membrane, which is fastened in a second step of the production over the frame, may in particular be a ready-made planar biomaterial plate made of material which is also resorbable and very thin, preferably 0.1-0.2 mm. This too is preferably made of a polylactide.

As a result, a biomaterial shell can be custom fabricated using a very low-cost technique and an already established and cost-effective material in a simple, low-cost 3D printer at very low production costs using the CAD-CAM process.

Since the frame makes up only a small part of the shell, it is also possible to manufacture it from a non-resorbable material, such as titanium, and later easier to remove than in a shell made entirely of titanium, whereas the resorbable membrane is thereby degraded.

The frame makes up only a small part of the shell. It is therefore also possible and compared to a shell made entirely of this material to use a resorbable material such as magnesium, since the lower material content also causes a reduction of negative properties. In particular, 3-dimensional solids from the materials described herein, which can be used in the here production techniques, with a very thin material layer of 0.1 mm to 0.25 mm despite the possible release of negative degradation products are not detrimental to bone healing.

Therefore, the frame according to the invention is made of either a resorbable or a non-resorbable material. All the compounds and substances suitable as biomaterial are suitable here. In particular, classical polymers such as PLLA, PGA, PCL, PEEK but also new biopolymers such as polyphosphates or silicates. Also suitable for this purpose are suitable metals and alloys, as well as ceramics. But there are also sugar compounds such as chitosan or compounds such as alginate or combination materials of different material classes and materials possible, including natural materials such as allogeneic or xenogenic bone. The following properties are important and can optionally be optimized by combination of materials: biocompatibility, osteoconductivity, osteoinductivity, resorbability, possibility of loading with drugs and other active substances and their release kinetics, mechanical properties such as modulus of elasticity and rigidity, as well as workability in the various possible manufacturing processes.

The resorbable biomaterial shell described herein can also be used as a membrane without pores, holes or mesh structure. Therefore, an additional collagen membrane is not mandatory and the risk of connective tissue formation is nevertheless very low.

• (i) der 3-dimensionale Festkörper des Rahmens mit Hilfe einer CAD-CAM-Technik additiv oder subtraktiv erzeugbar ist.

Further preferred embodiments of the device according to the invention are those wherein

• (i) the 3-dimensional solid body of the frame can be generated additively or subtractively using a CAD-CAM technique.

Resorbable material shells made of biocompatible material (biomaterial) are preferred. This biomaterial can be a suitable metal such as medical titanium or magnesium. The biomaterial may also be a suitable ceramic such as hydroxyapatite or tricalcium phosphate. The biomaterial may also be bone, a polymer, a polyphosphate compound, or a suitable mixed compound.

In the case of using a 3D additive printing technique, a preferred embodiment is a biomaterial of the thermoplastic polymer type which is solid at room temperature of about 20 ° C and liquid in a temperature range (pressure temperature) of 40 ° C to 300 ° C. Preferably, this temperature range is 80-260 ° C, preferably 90-250 ° C according to commercial 3D printers or bio-plotters. In particular, at a temperature of about 210 ° C when using PLLA (polylactic acid or PLA) or at a temperature of about 110 ° C when using PCL (polycaprolactone) or at a temperature of about 230 ° C when using PGA (polyglycolic acid, polyglycolic acid or polygycolide) or at a temperature of about 60 ° C when using PLGA (poly (lactide-co-glycolide)). Analogously, other preferred temperatures correspond to the melting range of the respective polymers.

In the case of using a subtractive CAD-CAM milling technique, a preferred embodiment is the use of titanium or magnesium. This material can then be used as a block of material in a suitable CNC milling machine, such as a Cerec cutter or fed continuously as a material bar.

• (ii) der Rahmen eine Stärke von 0,1–0,5 mm aufweist
• (iii) die Membran eine Stärke von 0,1–0,2 mm aufweist.
• (iv) die Membran aus einem geeigneten resorbierbaren Material besteht.

Further preferred embodiments of the device according to the invention are those in which:

• (ii) the frame has a thickness of 0.1-0.5 mm
• (iii) the membrane has a thickness of 0.1-0.2 mm.
• (iv) the membrane is made of a suitable resorbable material.

• (v) die Oberflächendaten, mit digitaler Volumentomographie (DVT/CBCT), Computer Tomographie (CT) oder Magnetresonanz- bzw. Kernspintomographie (MRT) des Knochendefektes ermittelt wurden.
• (vi) der 3-dimensionale Festkörper des Rahmens aus resorbierbarem Polymers mit einem 3D Drucker in einem Schmelzschichtverfahren bei handelsüblicherwesie grobregulierten Temperaturen, insbesondere bei 100 bis 300°C erzeugbar ist.
• (vii) das resorbierbare Polymer ausgewählt ist aus der Gruppe bestehend aus Polylactid (PLA), Polyglycolid (PGA) und Polycaprolacton (PCL).
• (viii) die Vorrichtung zusätzlich ein oder mehrere Befestigungselemente aufweist.

Preference is given to materials which are commercially easy to produce and are to be applied to the 3D frame. These include, for example: polymers such as PLLA, PGA, PCL, PEEK, but also collagen, demineralized bone, chitosan, magnesium or other biomaterials which are flexible or plastically deformable and can be pinned on the frame.

• (v) the surface data were determined by digital volume tomography (DVT / CBCT), computed tomography (CT) or magnetic resonance imaging (MRI) of the bone defect.
• (vi) the 3-dimensional solid body of the resorbable polymer frame is producible with a 3D printer in a melt-layer process at commercially controlled coarsely regulated temperatures, in particular at 100 to 300 ° C.
• (vii) the resorbable polymer is selected from the group consisting of polylactide (PLA), polyglycolide (PGA) and polycaprolactone (PCL).
• (viii) the device additionally comprises one or more fasteners.

The polymer filaments (filaments) usually stored on rolls and supplied preferably have commercial diameters of, for example, 1.75 mm or 2.85 mm or 3.00 mm and are stored on rolls from which they are rolled into the 3D printer.

In particular, the printing nozzles of the plastic-jet-printing technology (PJP) 3D printer have a diameter of commercially available 0.1 mm or 0.25 mm or 0.40 mm or 0.60 mm or 0.85 mm.

The membrane has a thickness of 0.1 mm to 0.25 mm, preferably a thickness of 0.1 mm is desired. The frame has a thickness of 0.1 mm to 0.5 mm, preferably 0.15 to 0.5 mm, in particular about 0.25 mm.

The following examples are intended to illustrate the invention without limiting it.

Example 1:

• • – Ein DVT-Datensatz des knöchernen Defektes wurde als DICOM Datensatz („Digitale Bildverarbeitung und -kommunikation in der Medizin”) aus dem SIDEXIS Programm der Firma Sirona, wie bei anderen DVT-Programmen auch, exportiert.
• • Dieser DICOM-Datensatz wurde in das Programm OsiriX eingelesen und ein STL-Datensatz der Oberfläche generiert und exportiert.
• • Dieser STL-Datensatz wurde in das Programm Slicer importiert. Das Programm Slicer wurde durch eine mit der Programmiersprache Python generierte Erweiterung so ausgestattet, dass der Defekt planungsgemäß virtuell ausgefüllt werden kann, um einen STL-Datensatz der herzustellenden Schale zu erhalten. Dieser STL-Datensatz wurde dann exportiert und wie oben beschrieben weiter benutzt, um den 3D-Drucker zur Erzeugung der Schale zu steuern.

A product according to the invention is, for example, a PLA-polylactic acid frame with an edge thickness of 0.25 mm, which was printed in an Ultimaker 2+ 3D printer with 2.85 mm PLA filament at a printing temperature of 210 ° C. The required print data record was generated as a gcode file with the program Cura from an STL record. The STL data set for the product according to the invention was generated as follows:

• • - A DVT record of the bony defect was exported as DICOM data set ("digital image processing and communication in medicine") from the SIDEXIS program of the company Sirona, as with other DVT programs also.
• • This DICOM data record was read into the OsiriX program and an STL record of the interface was generated and exported.
• • This STL record has been imported into the Slicer program. The program Slicer was equipped by an extension generated with the programming language Python in such a way that the defect can be virtually filled in according to plan, in order to receive an STL data set of the shell to be produced. This STL record was then exported and continued as described above to control the 3D printer to create the shell.

In a second step, a PLA membrane is then applied with a layer thickness of 0.1 mm and adapted with slow heat application formable to the frame. The fixation can be done mechanically by folding around holder edges of the frame. In compliance with existing protection rights of the Sonic Weld system, lactide welding is also possible.

Example 2:

The preparation of a polycaprolactone (PCL) frame according to the invention is carried out. In this case, the production of the virtual model takes place in the same way as in example 1. The 3D printing then takes place with the surface data of the shell to be printed as follows:
PCL with a molecular weight of about 79 kDa is printed with a bio-3D printer "Bioscaffolder" (Envisiontec GmbH, Gladbeck, Germany), wherein molten polymer with PJP technology is pressed through a 23 Ga heat nozzle (temperature: 110 ° C.) and printed by the conventional layer-by-layer technique, analogous to a standard Ulimaker 2+ printer, at a protrusion speed of the table of 350 mm / min.

In a second step, a collagen membrane is then applied and firmly glued to the frame with PLA under heat application. The fixation can also be done mechanically by clamping around holder elements of the frame. In compliance with existing protection rights of the Sonic Weld system, lactide welding is also possible.

Example 3:

There is the preparation of a frame according to the invention made of titanium. In this case, the production of the virtual model takes place in the same way as in example 1. The production of the CAM then takes place additive with the surface data of the shell to be printed, as follows:
It is sintered titanium powder in a laser sintering machine with the usual layer-by-layer technique, analogous to a conventional Ulimaker 2+ printer for 3D frame shape. In a second step, a collagen membrane is then applied and firmly glued to the frame with PLA under heat application. The fixation can also be done mechanically by clamping around holder elements of the frame. In compliance with existing protection rights of the Sonic Weld system, lactide welding is also possible.

Example 4:

There is the production of a frame made of magnesium according to the invention. In this case, the virtual model is first of all produced in the same way as in Example 1. The production of the CAM is then performed subtractively with the surface data of the shell to be printed as follows:
It is a magnesium block in a suitable form used in a Cerec milling machine. This then mills the rough shape of the frame. There then takes place the manual smoothing of edges and removal of material surpluses, which were possibly necessary for stable production. In a second step, a magnesium membrane is then applied and welded to the frame with heat application.

While particular embodiments of the invention have been shown and described, it would be obvious to those skilled in the art that changes and modifications can be made thereto without departing from the invention in its broader aspects. Therefore, the aim of the appended claims is to cover all such changes and modifications as fall within the true spirit and scope of the invention.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• EP 2536446 [0010]

Cited non-patent literature

• Matti H 1929 [0005]
• Wolter D 1976 [0005]
• Gellrich, NC, U. Held, R. Schoen, T. Pailing, A. Schramm and KH Bormann (2007). "Alveolar zygomatic buttress: A new donor site for limited preimplant augmentation procedures." Journal of Oral & Maxillofacial Surgery 65 (2): 275-280. [0008]
• Khoury, F. (2013). "The bony lid approach to pre-implant and implant surgery: a prospective study." Eur J Oral Implantol 6 (4): 375-384 [0008]
• Iglhaut, G., F. Schwarz, M. Grundel, I. Mihatovic, J. Becker and H. Schliephake (2014). "Shell technique using a rigid resorbable barrier system for localized alveolar ridge augmentation." Clin Oral Implants Res 25 (2): e149-154 [0008]
• Saito, Eiji, et al., Journal of Tissue Engineering and Regenerative Medicine 7, no. 2 (2013): 99-111 [0014]
• Seyednejad, Hajar, et al., Functionalized Polyesters 7, no. 5 (2012): 87 [0015]

Claims (12)

A device for covering and / or reconstructing a bone defect site comprising a void space between the defect surface and the bone defect facing surface of the device forming an attachment comprising: a 3-dimensional solid forming a frame, and a membrane mounted thereon both consisting of the same or different biomaterials and having a surface facing away from the bone defect and a surface facing the bone defect, characterized in that the dimensions and 3-dimensional geometry of the frame are determined by the surface defect data obtained by a slice imaging technique were further processed using CAD-CAM technology. Device according to claim 1, wherein the membrane has a thickness of 0.1 to 0.2 mm and / or the frame has a thickness of 0.1 to 0.5 mm. Device according to one of claims 1 to 2, wherein the surface data, with digital volume tomography (DVT / CBCT) or computer tomography (CT) or magnetic resonance imaging of the bone defect were determined. Device according to one of claims 1 to 3, wherein the 3-dimensional solid body of the frame can be generated by means of a 3D printer. Device according to one of claims 1 to 4, wherein the 3-dimensional solid body of the frame of a resorbable polymer with a 3D printer in a melt layer method at commercial prevail rough regulated temperatures, in particular at temperatures of 100 to 300 ° C, can be generated. The device of any one of claims 1 to 5, wherein the resorbable polymer is selected from the group consisting of polylactide, polyglycolide, and polycaprolactone. Device according to one of claims 1 to 3, wherein the 3-dimensional solid body of the frame made of a metal with a CAD-CAM additive laser sintered printer in a melt layer method is generated. Device according to one of claims 1 to 3 and 7, wherein the 3-dimensional solid body of the frame of a resorbable metal, preferably selected from the group consisting of magnesium or a magnesium alloy, is generated. Device according to one of claims 1 to 3, wherein the 3-dimensional solid body of the frame is made of a metal with a subtractive CAD-CAM milling machine. A method for producing an attachment for a device for covering and / or reconstruction of a bone defect site according to one or more of claims 1 to 9, the method comprising the following steps: (a) inputting the surface defect data of the bone defect into a data processing equipment as determined by a layer-forming method; (b) further processing of this surface data with a CAD technique, (c) controlling an additive or subtractive CAD-CAM manufacturing unit with the corresponding further processed data; (d) generating the biomaterial frame with an additive or subtractive CAD-CAM manufacturing unit; (e) attaching a membrane of a resorbable biomaterial to the frame obtained according to (d). A biomaterial consisting of a frame forming 3-dimensional solid for producing a device according to any one of claims 1 to 9, characterized in that its dimensions and 3-dimensional geometry by the surface data of a bone defect obtained by means of a layer imaging method and means CAD technology were further defined. A system for producing a framework for a device for covering and / or reconstructing a bone defect site according to one or more of claims 1 to 9, the system comprising the following components: (I) a data processing system for inputting the surface defect data obtained by a slice imaging method; on which a software is loaded, which processes this surface data by means of CAD technology; (II) an additive or subtractive CAD-CAM manufacturing unit which contains as a production medium a sufficient supply of a biomaterial and is controlled by the data input and further processed in the component (I); (III) a work plane on which the essay is generated; (IV) if applicable, a packaging unit connected thereto, in which the packaging unit in the Component (III) is packaged under sterile conditions.

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