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    • 专利摘要:
    The invention relates to a method for producing a biomaterial shell for covering and / or reconstructing a bone defect, which has a cavity that can be filled with a material between the defect surface and the surface facing the bone defect and the surface of the biomaterial shell facing the bone defect. In this process, surface data of the bone defect site are obtained with the aid of a layer formation process. These surface data are further processed in a data processing system using CAD technology and used to produce a 3D shaping model. A biomaterial membrane is applied to the 3D shaping model and adapted after hardening, or a hardenable or polymerizable biomaterial in amorphous form is applied and hardened or polymerized.
    公开号:CH714037B1
    申请号:CH01491/18
    申请日:2017-06-02
    公开日:2021-06-30
    发明作者:Draenert Florian
    申请人:Draenert Florian；
    IPC主号:
    专利说明:

    BACKGROUND OF THE INVENTION
    1. TECHNICAL FIELD
    The invention relates to a method for producing a biomaterial shell for covering and / or reconstructing a bone defect, which has a cavity that can be filled with a particulate material between the defect surface and the surface of the biomaterial shell facing the bone defect, according to claim 1.
    Further objects of the invention are a shaping model for use in the method and a data carrier onto which executable software for carrying out the method according to the invention is loaded.
    2. PRIOR ART
    There is a great need for biomaterials for the replacement of bone tissue and as a lead structure for the growth of new bone, in bone surgery, in orthopedics, dentistry and other areas for the restoration of bony structures after age-related resorption or loss by other causes, such as Tumor resection, tooth loss, trauma or other.
    If there is not enough bone available, bone grafting is carried out. This can be an elevation of the alveolar ridge or a sinus floor elevation. Bone augmentation uses either autologous bone from the same individual or foreign material. The foreign material can either be of natural origin (e.g. donor bones) or artificially produced (e.g. some hydroxyapatite products). The bone formation can take place either in particular or as a block, whereby 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.
    To increase the alveolar ridge or large lateral deposits with sufficient height, for example, the following technique is known: A bone block from the same patient is milled out at a removal point (e.g. jaw angle) or appropriate biomaterial is used and transplanted to the desired implantation site and either pressed accurately Fixed in the local bone without auxiliary material or with an osteosynthesis screw. In a second procedure, the screw is removed if necessary and the relevant dental implant is inserted. It is also conceivable to use a tooth implant directly and completely on one side in such a bone cylinder.
    Various materials can be used for bone structure. Either autologous bone or artificial biomaterial or prepared natural biomaterial from xenogenic or allogeneic 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). Xenogeneous materials are also used here (e.g. equine Biotek block).
    It is known that particulate material or blocks with a pore system heal better than solid material, since solid material has to be completely dismantled and rebuilt in a lengthy manner.
    It is also known that in the case of blocks with a pore system there is no complete replacement of the trabeculae with new bone, even if this material is basically resorbable. For these reasons, techniques that predominantly use particulate matter are superior to other techniques. However, since mechanical stabilization is necessary when the alveolar ridge is raised or there are large lateral deposits, thin, stable elements are used for this purpose, which enclose the particulate material. These techniques are grouped under the term shell techniques, as the thin stabilizing barrier works like a shell.
    According to the prior art, this shell technique can be carried out using the following techniques that have been known for many years: Shell of an allogeneic cortical bone, the bone being adapted to the defect by means of milling. This technique is very old. • Shells of an autologous cortical bone which was taken from the same patient and taken, for example, from the area 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 in pre-implant and implant surgery: a prospective study. "Eur J Oral Implantol 6 (4): 375-384). • Shells made of non-resorbable material (e.g. titanium mesh, metal-reinforced PTFE membranes) which are manually adapted to the defect by bending. Classic examples are the Cytoplast membrane, Goretex membrane, Neoss membrane, Tiolox membrane. • Bowls made from lactides (Iglhaut technology / Sonic Weld System), which are made malleable by heating and are 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 known problem is the poor fit of these manually adjusted shells. In addition, manual adjustment requires an enormous amount of time in the OR.
    European patent application EP 2 536 446 from ReOss proposes a correspondingly individually adapted device, with surface data of a bone defect being generated from a slice imaging and the defect being virtually filled in a CAD program. A 3D data set for the production of a shell for the application of the shell technology is created from this data.
    The ReOss company actually implemented and currently being implemented products include individual, customer-made with CAD-CAM technology, perforated membranes (mesh grids) made of metals. Here, surface data of the defect are generated from slice imaging and the defect is virtually filled in a CAD program. From this data, a 3D data set is created for a shell for the application of shell technology and a titanium mesh shell is used for printing, which is welded from titanium particles using a laser sintering process 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 because it is not resorbable. 2. Magnesium leads to gas formation during resorption, which considerably impairs bone healing. 3. Both materials have to be produced in a complex special 3D welding CAM system and thus lead to high costs. 4. Both systems work with a network that has holes (mesh), which requires an additional cover with a collagen membrane in order to avoid unfavorable ingrowth of connective tissue instead of bone.
    The present invention was based on the object of providing a method for producing an individually adapted device for covering and / or reconstructing a bone defect which does not have the disadvantages of the previously known devices and methods or only to a reduced extent.
    BRIEF SUMMARY OF THE INVENTION
    This object was achieved according to the invention by a method for producing a device for covering and / or reconstructing a bone defect which has a cavity between the defect surface and the surface of the device facing the bone defect that can be filled with a particulate material, comprising an attachment in the form of a thin membrane made of a resorbable biomaterial, which has a surface facing away from the bone defect and a surface facing the bone defect, and • its dimensions and 3-dimensional geometry of its edges are defined by the surface data of the bone defect, with the data obtained with the help of a layer imaging process and CAD -Technique further processed surface data can be used to produce a 3-dimensional shaping model on which either a biomaterial membrane is applied and adapted to it, or a hardenable or polymerizable Bi omaterial is applied in amorphous form and cured or polymerized.
    Another object of the invention is a 3-dimensional shaping model for performing the method according to the invention, the dimensions and the 3-dimensional geometry of its edges are defined by the surface data of a bone defect, it being based on the obtained with the help of a layer imaging method and surface data processed further by means of CAD technology can be generated in an additive or subtractive CAD-CAM production unit, preferably in a 3D printer.
    The invention also relates to a system for carrying out the method according to the invention, the system comprising the following components: (I) a data processing system for inputting the surface data of the bone defect obtained by means of a slice imaging method, on which software is loaded that uses this surface data CAD technology further processed; (II) an additive or subtractive CAD-CAM production unit, preferably a 3D printer, which contains a sufficient supply of a printable material as a printing medium, which is controlled by the data entered and further processed in component (I); (III) a working plane on which a 3-dimensional shaping model is generated; (IV) optionally a packaging unit connected to it, in which the 3-dimensional shaping model produced in component (III) is packaged under sterile conditions; (V) a device with the aid of which a flat membrane made of a resorbable biomaterial can be adapted to the surface of the 3-dimensional shaping model.
    Another object of the invention is a loaded onto a data carrier, executable software for performing the controlled by a data processing system steps of the method according to the invention, in particular wherein it assigns a unique identification number to the surface data of each detected bone defect and this during the production of the shaping model according to the invention or the 3-dimensional model of the bone defect site.
    BRIEF DESCRIPTION OF THE DRAWING
    Fig. 1 shows a schematic representation of the preferred method for producing the shaping model (the bending form): The data of a slice imaging (e.g. CT or DVT) are converted into surface data of the defect as part of the CAD process. Then the CAD reconstruction of the defect and the export of this surface data for 3D-CAM printing take place.
    DETAILED DESCRIPTION OF THE INVENTION
    According to this invention, a method for producing a biomaterial shell (device) for covering and / or reconstructing a bone defect site for use in a surgical bone building technique with thin stabilizing walls (shell) to improve bone healing of defects and / or osseointegration of implants , which is made available on a shaping model (bending model), which was individually produced by means of 3D printing on the basis of surface data of the bone defect and is bent from a prefabricated flat material plate.
    The preferred sequence of the method according to the invention is shown in detail below: 1. Slice imaging is carried out to depict the bony defect (preferably DVT or CT). 2. The DICOM data of the slice imaging are exported as surface data of the bony surface (e.g. STL data set) and read into a program for processing the surface data (e.g. Slicer). 3. The bony defect is virtually filled in or reconstructed in the program. 4. The surface data of the reconstructed defect are exported as a surface data set and printed as a 3D model either directly or after being transferred to a 3D print data set (e.g. gcode file for Ultimaker printer). 5. This 3D model serves as a CAD-CAM-shaping model (bending shape) for adapting a plan ("2-dimensional") biomaterial plate to a 3-dimensional suitable biomaterial shell (device for covering and / or reconstructing a knuckle defect) ) for implantation in the patient. This adaptation can take place, for example, in a heat bath if the biomaterial is, for example, a polylactide membrane. To simplify the process, the biomaterial plate is preferably packaged in size and packaged in a watertight and sterile manner, so that a clear selection of standardized sizes of planar biomaterial plates or, ideally, a single size can be used for any different defects and can be individually adapted using this method.
    The term “device” as it is used above and below denotes an aid suitable for covering and / or reconstructing a bone defect site in the form of a shell made of a resorbable biomaterial (“biomaterial shell”), the edges of which are determined by the dimensions of a Bone defect are defined. The terms “biomaterial shell for covering and / or reconstruction of a bone defect site” and “device for covering and / or reconstruction of a bone defect site” are used synonymously.
    The term "shaping model" or "bending shape", as it is used above and below, denotes a 3D model that is true to scale the surface of the virtually reconstructed defect and for bending the planar biomaterial plate, for example after Heat softening with hot water, or used to create the curved biomaterial shell by curing or polymerizing a curable or polymerizable biometric precursor. This bending shape is preferably produced on the reconstructed defect with the aid of a 3D printer, preferably using plastic jet printing technology (PJP).
    The term “biomaterial membrane” as used above and below denotes a thin, biocompatible membrane or film.
    The term "software" or "app" as it is used above and below relates to an executable computer program written in any programming language, which can be used on desktops, personal computers, tablets, smartphones and smartwatches of any kind under Windows, Mac or Android is readable and executable.
    It means in particular an app that is loaded on a data carrier, preferably a DVD, a CD, a USB stick, a drive of a desktop or personal computer, a file server or a cloud and loaded executable on a desktop or personal computer can be. For example, it can be downloaded from an app store or used entirely online.
    The data of a patient's bone defect can be uploaded and used in a cloud or, if the app is downloaded, can also be used locally.
    The preferred embodiment of the invention uses the plastic jet printing technology (PJP) to produce the shaping model, the plastic usually being supplied as filament thread from a roll. In a 3D printer of this type (e.g. Ultimaker 2+) the shaping model is printed by pulling the material out of the cartridge via feed hoses through the pressure jets. The material is then sprayed through the pressure jets in a thin jet. The movement of the print jet is coordinated by the printing plate, which lowers after each layer is created so that a new layer can be applied to the last. In this way, step by step, the object is created in the form of a solid filament. This technique is a 3D printing using melted materials and is also known as Fused Filament Fabrication (FFF), fused layering (e.g. FDM - Fused Deposition Modeling).
    On the basis of the layer described above, a 3D object is preferably built on a movable and / or heated platform. The printhead is a heated extruder that melts the supplied material (in wire or rod form). Depending on the model, either the nozzle itself and / or the platform below is moved. The speed of such a printer is adapted to the time it takes for the material used to cool and harden. Only when the layer below has solidified is the next level applied. The quality of such a printer depends 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 additional extruders and colored materials, colored objects can also be created.
    In an alternative method, such a resorbable solid filament can also be produced with the aid of another 3D printing technique.
    Overall, there are various techniques in addition to the plastic jet printing technology (PJP) described for 3D printing.
    Similar to a "normal" paper printer, a 3D printer also requires a digital file which provides the information about the object to be printed. While a .doc or .txt file with the text content is used with paper printers, with “digital fabrication” a file format is used which contains information about the 3D model of the bone defect. In order to be able to build the object from a 3D model, it must first be (digitally) cut into individual 2-dimensional, horizontal slices (layers). Such a file format with the information of all individual layers is, for example, an .STL or .AMF file. On the basis of such a file, every current “3D printer” can build an object from the sum of the individual 2D layers.
    Additive Manufacturing (AM) in German also generative manufacturing describes a variety of technical processes that ASTM International, 2012 in English in the areas of vat photopolymerization, material jetting, binder jetting, material extrusion, powder bed fusion, sheet lamination or directed energy deposition. Some of these procedures are very similar in principle and only differ in a few changes.
    The present invention relates in particular to those devices, methods and systems that use commercially available 3D printers with plastic jet printing technology (PJP) with solid filaments that use heat to perform a 3D printing from a solid material thread (filament) from a feed roller ( Plastic Jet Printing Technology (PJP 3D Printer), can be generated. The use of polylactide (PLA) or polyglycolide (PGA) is particularly preferred here, as this is established in the commercial sector. In addition, all other materials can be used which are absorbable and can be produced using the technology mentioned.
    1. Imaging and CAD planning
    Slice imaging takes place, which is most commonly used in practice as computed tomography (CT) or digital volume tomography (DVT / CBCT). This examination provides slice images, which are usually ported to other systems and programs in DICOM format, but can also be further processed in proprietary file formats. Surface data are then created from these slice image data. A common file format here is the STL data format. For example, a DICOM data record can be exported as an STL data record in the OsiriX program. This STL data record can then be processed in a program for processing surface data, such as, for example, Slicer, in such a way that the bony defect is virtually filled and a surface data record of the desired reconstructed shape is thus obtained. This data record can be used, for example, as an STL data record directly or after conversion into a control data record for CAM production by a 3D printer to produce a physical model of the desired reconstruction. The software according to the invention imports and, if necessary, digitizes the data of the slice imaging and transfers them to a data set that can control a 3D printer or a material milling machine. At the same time, it assigns an identification code to every detected bone defect, which later allows the model to be assigned to a specific patient.
    2. CAM production of the shaping model (bending form)
    The present invention relates in particular to the use of commercially available 3D printers or material milling machines for producing the shaping model (bending form). This model is a shape of the bone with the already virtually filled defect (planning of results and thus the shape specification of the augmentation) in order to either bend the biomaterial plate 3-dimensionally or to produce it by curing or polymerizing a corresponding amorphous precursor material on the surface of the model. The data record for producing the bending shape (shaping model) is converted into a physical 3D shape using the 3D printer as a CAM machine. The most common methods for this include: • Heat filament 3D printing from thermoplastics, which are usually fed from reels as filament threads. E.g. Ultimaker 2+ 3D printer • Sterolithography printer, which creates the 3D objects from a liquid material reservoir by means of 3D activation (e.g. laser / light-controlled). E.g. Formlabs Form2-Printer • Plastic jet printing technology (PJP) with powder. E.g. the CubePro 3D printer or ProJet® 1200 printer from 3D Systems Inc. prints the objects by pulling the material out of the cartridge via feed hoses through the pressure jets. The material is then sprayed through the pressure jets in a thin jet. The movement of the print jet is coordinated by the printing plate, which lowers after each layer is created so that a new layer can be applied to the last. This is how the object is created step by step.
    The bending form obtained (shaping model) can either be sterilized and used in a sterile heat bath to adjust the biomaterial plate or used non-sterile if the biomaterial remains sterile packaged during bending or, as a third variant, is sterilized after bending.
    3. Adaptation of the planar biomaterial plate with the bending form (with the shaping model) for the production of the biomaterial shell.
    A planar biomaterial plate, as is already on the market from KLS Martin, is preferably used as the shell. As described, this shell with the bending shape (shaping model) is adapted to the individually planned bone reconstruction.
    Here, the use of absorbable or non-absorbable material is possible as the biomaterial from which the membrane according to the invention is made. All compounds and substances suitable as biomaterials come into consideration here. In particular, classic polymers such as PLA (polylactide), PGA (polyglycolide), PCL (polycaprolactone), PEEK (polyether-ether-ketone), but also new biopolymers such as polyphosphates or silicates. This also includes suitable metals and alloys, as well as ceramics. However, sugar compounds such as chitosan or compounds such as alginate or combination materials from different material classes and materials are also possible, including natural materials such as allogeneic or xenogeneic bones. The following properties are important here and can be optimized by combining materials if necessary: biocompatibility, osteoconductivity, osteoinductivity, resorbability, the possibility of loading drugs and other active substances and their release kinetics, mechanical properties such as modulus of elasticity and rigidity, as well as machinability in the various possible manufacturing processes.
    A preferred embodiment of the membrane is polylactide (PLA) or polyglycolide (PGA) or polycaprolactone (PCL). This can be softened by controlled heat in a bath of liquid and adapted to the shape. There are three preferred procedures for this: • The bending form and biomaterial are packaged separately or together in a sterile manner and the bending takes place in the operating room. • The bending form remains unsterile and the biomaterial is packed sterile and, if necessary, watertight in the pack, so that it can be bent without sterilizing the bending form. • The bending shape and biomaterial are non-sterile during bending and the sterilization of the biomaterial takes place after bending.
    With a very thin material layer of 0.1 mm to 0.25 mm, polylactide dishes or other dishes are not detrimental to bone healing despite the release of acidic lactide degradation products, which is known from the data of the SonicWeld system.
    The resorbable biomaterial shell described here can also be used analogously to the known shapes from the SonicWeld system as a membrane without pores, holes or mesh structure. A collagen membrane is therefore not absolutely necessary and the risk of connective tissue formation is nevertheless low.
    In addition, all other biomaterials can be used, which can be packed in ready-made flat shapes and later molded on.
    3. Production of the biomaterial shell on the shaping model.
    For this purpose, a hardenable or polymerizable precursor of the biomaterial in amorphous or fluid form as a gel, powder, suspension, lacquer or film is applied to the shaping model. Suitable polymerizable precursors are monomers such as lactide (3,6-dimethyl-1,4-dioxane-2,5-dione), ε-caprolactone (6-hydroxyhexanoic acid lactone), acrylic acid and methacrylic acid and their corresponding esters, in particular ε-caprolactone.
    Then the hardening or polymerisation of the material is awaited, which takes on the predetermined 3D shape by the shaping model. Overhanging edges are cut and milled. Then a suitable outer packaging and radiation sterilization takes place.
    One possibility for this is to mix a viscous two-component liquid in situ, which then polymerizes on the surface of the shaping model, for example with the aid of a two-chamber syringe of the commercially available Straumann® MembraGel ™, from Institut Straumann AG, CH-4002 Basel, Switzerland
    Another preferred possibility is to apply a paste of a solvent and granules coated with lactide to the surface of the shaping model, to remove the solvent by adding water, whereby the paste solidifies. Such systems are commercially available, for example, as GUIDOR® easy-graft from Sunstar Suisse S.A., 1163 Etoy, Switzerland.
    As a result, with a very cost-effective technology and an already established and cost-effective material in a simple 3D printer in the price range, an individually adapted biomaterial tray can be produced at low production costs.
    Preferred embodiments of the method according to the invention are those in which (i) the 3-dimensional shaping model is produced with the aid of an additive or subtractive CAD-CAM production device. (ii) the membrane is 0.1-0.2 mm thick. (iii) the surface data of the bone defect are determined with digital volume tomography (DVT / CBCT), computer tomography (CT) or magnetic resonance or magnetic resonance tomography (MRT). (iv) the 3-dimensional shaping model is produced with a 3D printer in a melt layer process at roughly regulated temperatures. (v) the 3-dimensional shaping model is produced with a 3D printer in a melt layer process at temperatures of 100 to 300 ° C. (vi) the membrane is made of a biomaterial. (vii) the membrane is selected from a resorbable polymer from the group consisting of polylactide, polyglycolide and polycaprolactone.
    An alternative variant of the method according to the invention for producing a biomaterial shell for covering and / or reconstructing a bone defect is a method comprising the following steps (a) input of the surface data of the bone defect determined by a layer imaging method into a data processing system, (b) further processing this surface data with a CAD technique, (c) control of a 3D printer with the corresponding further processed data; (d) generating a 3-dimensional model of the bone defect site with the 3D printer; (e) Filling the model of the bone defect with a plastically deformable material for reconstructing the defect and thus a resulting model of the original bone surface; (f) optical surface scan of the model surface reconstructed in (e); (g) further processing of the surface data obtained in (f) with a CAD technique, (h) control of a 3D printer with the correspondingly further processed data; (i) generating a 3-dimensional shaping model with a CAM unit, (j) applying and adapting a planar biomaterial membrane; or (k) applying a curable or polymerizable biomaterial in amorphous or fluid form and curing or polymerizing the same.
    The filaments used in a 3D printer preferably have commercial diameters of, for example, 1.75mm or 2.85mm or 3.00mm and are stored on rollers from which they are unrolled in the 3D printer.
    The printing nozzles of the heat technology filament 3D printer have, for example, 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 planar biomaterial plates for bending according to the invention have a thickness of 0.1 mm to 0.25 mm, a thickness of 0.1 mm preferably being aimed for.
    The following examples are intended to explain the invention without restricting it.
    Example 1:
    Bending at the manufacturer and delivery of the finished bent product:
    A product according to the invention is, for example, a PLA polylactic acid plate, such as that from KLS Martin, with a thickness of 0.1 mm in area. The bending shape is now first produced: • A DVT of the patient in a Sirona Galileos DVT device is made. • A DVT data record of the bony defect is exported as a DICOM data record from the Sirona Sidexis program, as is the case with other DVT programs. • This DICOM data record is read into the OsiriX program and an STL data record of the surface is generated and exported. • This STL data record is imported into the Slicer program. The Slicer program is equipped with an extension generated with the Python programming language so that the defect can be virtually filled as planned in order to obtain an STL data record of the desired shell. This STL data record is then exported and then used for the CAM production of the bending form. • The bending form is produced in an Ultimaker 2+ 3D printer with 2.85 mm PLA filament at a printing temperature of 210 ° C. The print data set required for this was generated as a gcode file with the Cura program from an STL data set.
    The biomaterial PGA plate with a thickness of 0.1 mm is then heated and adapted to the bending shape. For this purpose, the plate is placed on the mold, positioning by holding it or positioning elements at the corners or edges of the mold. Then moist heat is applied from above using a steam gun. The PGA plate softens and sinks onto the bending shape, thus assuming the specified 3D shape.
    The edges are cut and milled. Then a suitable outer packaging and radiation sterilization takes place.
    Then the implantation and, if necessary, fixation with osteosynthesis screws takes place in the defect area of the patient during an operation, as well as filling with particulate biomaterial and / or autologous bone.
    Example 2:
    Bending during surgery by the surgeon where the bending shape is sterile:
    A bending mold is produced as described in Example 1. This bending shape is packaged in accordance with the law and sterilized by radiation. During the operation, a heat bath with a liquid filling is set up in a sterile manner, as is provided for in the Sonic Weld system. The sterile bending mold is then brought into the bath. Then a sterile biomaterial plate is applied to this bending form and, after softening by the heat bath, it is adapted to the bending form in order to obtain the desired shape. The edges are trimmed and smoothed.
    Then the implantation and, if necessary, fixation with osteosynthesis screws takes place in the defect area of the patient, as well as underfilling with particulate biomaterial and / or own bone.
    Example 3:
    Analog augmentation of the defect:
    A product according to the invention is, for example, one according to Example 1 or 2, with the following procedure taking place for the production of the bending shape: A DVT of the patient in a Sirona Galileos DVT device is produced. • A DVT data record of the bony defect is exported as a DICOM data record from the Sirona Sidexis program, as is the case with other DVT programs. • This DICOM data record is read into the OsiriX program and an STL data record of the surface is generated and exported. • This STL data record is used to create an analog model of the defect with a 3D printer or another suitable CAM system. For example in an Ultimaker 2+ 3D printer with 2.85mm PLA filament at a printing temperature of 210 ° C. • The defect on the model is filled with a suitable plastic material in order to achieve an augmentation of the defect. • The optical surface scan of the analog augmented defect is then carried out. This scan directly or indirectly results in an STL data record of the surface. This can be done, for example, with an Omnicam from Sirona and its software from the Cerec product range. However, a stationary model scanner is also conceivable. • This STL data record is then exported and then used for the CAM production of the bending form. • The bending form is produced in an Ultimaker 2+ 3D printer with 2.85 mm PLA filament at a printing temperature of 210 ° C. The print data set required for this was generated as a gcode file with the Cura program from an STL data set. • The biomaterial PGA plate with a thickness of 0.1 mm is then heated and adapted to the bending shape. For this purpose, the plate is placed on the mold, positioning by holding it or positioning elements at the corners or edges of the mold. Then moist heat is applied from above using a steam gun. The PGA plate softens and sinks onto the bending shape, thus assuming the specified 3D shape. • The edges are cut and milled. Then a suitable outer packaging and radiation sterilization takes place. • Then the implantation and, if necessary, fixation with osteosynthesis screws in the defect area of the patient takes place during an operation, as well as underfilling with particulate biomaterial and / or autologous bone.
    Example 4:
    Application of an amorphous material for later hardening on the shaping model:
    A biomaterial shell according to the invention is produced, the following sequence taking place: A shaping model is produced according to one of Examples 1, 2 or 3; • The biomaterial precursor is then applied in a thickness of about 0.1 mm in amorphous form as a gel or powder or suspension or lacquer to this shaping model. For this purpose, ε-caprolactone, for example, is applied to the mold as a gel / suspension or powder. ε-caprolactone has a seven-membered ring structure. Correspondingly, it can then be subjected to a ring-opening polymerization by adding various catalysts and optionally initiators, for example M. Labet, W. Thielemans, Chem. Soc. Rev., 2009, 38, 3484-3504. Lewis acids, such as zinc or titanium derivatives, or Brønsted acids, such as carbonic acid or ammonium chloride, are preferably used. Another possibility is to heat the applied ε-caprolactone in the presence of an initiator (e.g. mesityl alcohol). It polymerizes in a chain polymerization to polycaprolactone (PCL), more precisely poly-ε-caprolactone. • When the material hardens, it takes on the desired, predetermined 3D shape due to the shaping model. • The edges are cut and milled. Then a suitable outer packaging and radiation sterilization takes place.
    Then the implantation and, if necessary, fixation with osteosynthesis screws takes place in the defect area of the patient during an operation, as well as underfilling with particulate biomaterial and / or autologous bone.
    Example 5:
    One patient, 45 years of age, had no contraindications according to the consensus conference and had a defect in region 16 of the gap. A digital volume tomography was created with a Sirona Galileos DVT device (voxel size 0.3 mm; 85 kV and 35 mAs). Volume density and region of interest (ROI) definition, as well as the virtual augmentation, took place directly in the image slices in the 3D Slicer program (version 4.5.0-1 r24735). An STL data set was exported from this, which was used to produce a 3D bending model in an Ultimaker 2+ printer with FDA-approved PLA filament. The correspondingly adapted KLS Martin 0.2mm Resorb x Poly-D, L-lactic acid (PDLLA) membrane (30 * 30mm, perforated) was placed in the upper jaw region 16 for vertical bone augmentation and augmented with autologous bone and Geistlich BioOss L. Postoperatively, the healing process was free of complications. The ISO regulations have been observed accordingly.
    Example 6:
    A patient, 55 years old, had no contraindications according to the consensus conference and had a large horizontal alveolar ridge defect in regions 12 to 14 with an edentulous upper jaw. Planning was carried out analogously to Example 5 up to the ROI definition. After an STL export, the surface data was read into Autodesk Meshmixer (version 11.0.544) and the virtual augmentation was carried out there much easier and faster. The further treatment was also carried out analogously to Example 5 with the same KLS Martin Resorb X membrane. Postoperatively, the healing process was free of complications. The ISO regulations have been observed accordingly.
    权利要求:
    Claims (13)
    [1]
    1. A method for producing a biomaterial shell for covering and / or reconstructing a bone defect, which has a cavity that can be filled with a particulate material between the defect surface and the surface of the biomaterial shell facing the bone defect, characterized in that- surface data of the bone defect site is obtained with the help of a layer imaging process,- these are further processed by means of CAD technology in a data processing system and used to produce a 3-dimensional shaping model,- to which either a biomaterial membrane is applied and adapted to it after softening,- or a curable or polymerizable biomaterial is applied in amorphous form and cured or polymerized.
    [2]
    2. The method according to claim 1, wherein the 3-dimensional shaping model is produced with the aid of a 3D printer.
    [3]
    3. The method according to claim 1 or 2, wherein the membrane has a thickness of 0.1-0.2 mm.
    [4]
    4. The method according to any one of claims 1 to 3, wherein the surface data are determined with digital volume tomography, computer tomography or magnetic resonance or magnetic resonance tomography of the bone defect.
    [5]
    5. The method according to any one of claims 1 to 4, wherein the 3-dimensional shaping model is produced with a 3D printer in a melt layer process.
    [6]
    6. The method according to any one of claims 1 to 5, wherein the 3-dimensional shaping model is produced with a 3D printer in a melt layer process at temperatures of 100 to 300 ° C.
    [7]
    7. The method according to any one of claims 1 to 6, wherein the membrane consists of a biomaterial selected from the group consisting of polylactide, polyglycolide, polycaprolactone, polyether-ether-ketone, polyphosphates, silicates, chitosan, alginate and combination materials thereof.
    [8]
    8. The method according to any one of claims 1 to 6, wherein the membrane is selected from a resorbable polymer from the group consisting of polylactide, polyglycolide and polycaprolactone.
    [9]
    9. The method according to any one of claims 1 to 8 for the production of a biomaterial shell for covering and / or reconstructing a bone defect site, which comprises the following steps:a) Input of the surface data of the bone defect determined by a layer imaging method into a data processing system,b) further processing of this surface data with a CAD technique,c) Control of a 3D printer with the corresponding further processed data;d) creating a model of the bone defect site with the 3D printer;e) filling the model of the bone defect with a plastically deformable material to reconstruct the defect and thus a resulting model of the original bone surface;f) optical surface scan of the model surface reconstructed in e);g) further processing of the surface data obtained in (f) with a CAD technique,h) Control of a 3D printer with the correspondingly processed data;i) Generation of a 3-dimensional shaping model with a CAM unit,j) applying and adapting a planar biomaterial membrane; ork) applying a curable or polymerizable biomaterial in amorphous or fluid form and curing or polymerizing the same.
    [10]
    10. Shaping model for use in a method according to one of claims 1 to 9, the dimensions and the 3-dimensional geometry of its edges are defined by the surface data of a bone defect, characterized in that it is based on the obtained with the help of a layer imaging method and by means of CAD technology further processed surface data is generated in an additive or subtractive CAD-CAM production unit.
    [11]
    11. Shaping model according to claim 10, characterized in that it is generated in a 3-D printer.
    [12]
    12. Data carrier onto which executable software for carrying out the steps of a method according to one of claims 1 to 9 controlled by a data processing system is loaded.
    [13]
    13. The data carrier according to claim 12, characterized in that the software loaded thereon assigns a unique identification number to the surface data of each detected bone defect and this during the production of the biomaterial shell according to one of claims 1 to 9 or the shaping model of the bone defect site according to claim 10 issues.
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    同族专利:
    公开号 | 公开日
    WO2017207808A1|2017-12-07|
    DE112017002813A5|2019-02-14|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    BE1007032A3|1993-04-28|1995-02-21|Ceka Nv|METHOD FOR MANUFACTURING A MEMBRANE FOR GUIDED BONE REGENERATION|
    DE10138373A1|2001-08-11|2003-03-06|Robert Eisenburger|Controlled reconstruction method for bone and suitable drilling template in the shape of membrane constructed from model of the actual jaw bone condition|
    ITMO20060159A1|2006-05-18|2007-11-19|Marcello Marchesi|"METHOD FOR GUIDED REGENERATION OF BONE AND / OR PERIODONTAL TEXTILES IN MEDICAL SURGICAL AND DENTAL DENTISTRY AND A PERMISSIBLE DEVICE."|
    WO2011100951A1|2010-02-19|2011-08-25|Marcus Seiler|Device for covering and/or reconstructing a bone defect site, and method for production thereof|
    DE102012002817B4|2012-02-15|2017-01-05|Knorrconcept Gmbh|Method for determining digital data sets for the production of dental prostheses|CN109177147A|2018-08-31|2019-01-11|上海大学|Comprehensive shaping system is printed using containing multi-jet Coaxial nozzle device biology CAD/CAM/3D|
    法律状态:
    优先权:
    申请号 | 申请日 | 专利标题
    EP16001266|2016-06-04|
    EP16001324|2016-06-12|
    EP16001407|2016-06-23|
    EP16002121|2016-10-04|
    EP16002466|2016-11-21|
    PCT/EP2017/063577|WO2017207808A1|2016-06-04|2017-06-02|Method for producing an individual biomaterial shell for reconstructing bone defects|
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