Classifications

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  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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  • G05B19/4097—Numerical control [NC], i.e. automatically operating machines, in particular machine tools, e.g. in a manufacturing environment, so as to execute positioning, movement or co-ordinated operations by means of program data in numerical form characterised by using design data to control NC machines, e.g. CAD/CAM
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  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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• • A—HUMAN NECESSITIES
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  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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• • A—HUMAN NECESSITIES
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  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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• • A—HUMAN NECESSITIES
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  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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• • B—PERFORMING OPERATIONS; TRANSPORTING
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Definitions

• the invention relates to a method for producing bone treatment agents, for example orthognathic osteosyntheses and / or templates.
• Adjacent methods are known, for example, from US patents US 8,855,389 B1 and US 2014/0094924 A1.
• US 8 855 389 B1 discloses a computer-implemented method for using a finite element method for bone implant systems. It also accesses a library of pre-engineered implant data. However, these data are applied / morphed onto an intact bone. In US 2014/0094924 A1, however, a mirror image of an intact / undamaged contralateral bone is used. Further prior art is known from US 201 1/0 151 400 A1.
• (original) 3D data of a bone or a bone section of a specific patient to be treated is to be acquired / retrieved, wherein there is a site to be treated within the bone or the bone section.
• This site is usually a defect or bone defect.
• this (original) 3D data of a bone or bone portion of the specific patient to be treated goes back to a data acquisition step, such as by CT, MRI, MRI, DICOM, or similar methods and devices.
• reconstructing step the two data sets are linked together in such a way that the completion or completion of 3D data for the reconstruction of the site to be treated takes place.
• trimming of the original 3D data or the obtained supplemented data is included or may be included based on the 3D data of the selected reference patient, thereby obtaining reconstructed and trimmed 3D data about bridging or supplementing a bone material defect in the patient to be treated.
• the data of the "reference patient” may in particular relate to a data set which has been composed of different individual patients, whereby, for example, averaging, median formation and / or other / similar algorithms may be used.
• the three steps of providing the original 3D data of the patient to be treated, adding the 3D data of the reference patient, and the step of supplementing are sequential or at least partially parallel. This will allow you to achieve 5-minute to 10-minute schedule cuts, and even achieve a total manufacturing time of ⁇ 12 hours if manufactured on site or 48 hours if a medical device company is physically turned on elsewhere.
• the bone treatment agent in the manner of an implant or a bone cutting template, is manufactured in a fourth step, a component to be fastened to the bone can be provided quite quickly.
• An advantageous embodiment is also characterized in that before the mirroring step and / or after the first step, a computer-aided 2D or 3D visualization is performed. The user-friendliness is thereby increased.
• bone marking points such as landmarks, "landmarks" or markings
• the range of application of the process is significantly expanded, of course it is it is possible to use the bone treatment agent to serve as a guiding and / or directing means for perforating, cutting or puncturing the bone after its attachment to the bone / bone portion.
• the patient can be helped faster than before, if before the fourth step, namely the manufacturing, in a generating step, 3D data and / or manufacturing data for controlling manufacturing machines, such as NC or CNC data generated and advantageously this NC or CNC Data are fed directly or indirectly into a manufacturing device, such as a control device of a milling, turning, sintering or welding system.
• a manufacturing device such as a control device of a milling, turning, sintering or welding system.
• Forming, forming, in particular machining and / or additive manufacturing processes can then be used quickly and efficiently.
• Particularly advantageous is the use of rapid prototyping techniques, such as 3D printing / 3D-printing techniques, especially those that use a * .3mf data format. It should be included in addition to geometry information and manufacturing information for additive and / or machining.
• a modeling step for achieving surfaces, axes, locations and / or deviation factors is carried out.
• An advantageous embodiment is also characterized in that the 3D data of the patient to be treated and / or the 3D data of the reference patient (s) in / on a database of a hospital or an I-cloud server (or a similar device) or a database of a medical device company. Both in-house, out-of-hospital and all-available data can then be used. In particular, by a web-based solution, the acceptance of the method is improved and facilitates the use.
• the 3D data of the reference patient (s) includes selection criteria such as smoking / non-smoking, sex, age, height, occupation, ethnicity and / or constitutional Including physiology information, the selection of each (individually) appropriate data for reconstructing the bone is facilitated.
• selection criteria such as smoking / non-smoking, sex, age, height, occupation, ethnicity and / or constitutional Including physiology information
• the selection of each (individually) appropriate data for reconstructing the bone is facilitated.
• constitutional physiology information classification by Kretschmer is appropriate, although its classification is controversial.
• the invention also relates to an apparatus for carrying out a planning and / or manufacturing method, wherein means are / are set up and prepared, which carry out the method according to the invention.
• a further development is that a computer is included / included, which is prepared and set up to perform the steps of the procedure automatically. An interaction with an operator is thus kept to a minimum.
• a use according to the invention is to use irregularities in a bone and thus to obtain a better diagnosis.
• a method or process is now described in which a surface and / or a volume is generated using statistical shape models, on which and / or in which the implant reconstruction and the templates for osteotomy are stored in a database.
• This allows bone treatment steps and / or bone treatment agents to be automatically adjusted and calculated for each individual.
• the bone treatment agents can also be adjusted individually and manufactured especially promptly.
• Statistical models of anatomical regions are suitable for medical planning. These are virtual models that allow you to supplement or replace missing or broken areas based on existing individual shape information.
• the statistical models for reconstructing the human bony support apparatus allow a higher accuracy than a simple / single mirroring of the healthy on the diseased side.
• a major advantage is that in the automated reconstruction of the pathologically or traumatologically altered bone merely an orientation based on Points or surfaces on localized bone is required to apply the statistical shape model and obtain a reconstruction independent of more elaborate segmentation techniques.
• the type and quality of the existing 3D image information of the individual is now independent of the result of the reconstruction by the statistical model. This also means that the presence of artifacts, for example due to metal screws, resulting in imperfect areas in diagnostic imaging procedures, can be eliminated and thus removed.
• Combining the statistical model with implant constructions means that they can be automatically adapted to the individual in question. By selecting typical fracture locations, e.g. automated individual implants are generated. Furthermore, there is an idea to collect the information of the individual reconstructions so as to obtain an implant optimization for standardized average implants.
• Cutting guides are required to perform calculated osteotomies on the bone. For example, In the case of a mandibular reconstruction, in which a bone graft is to be inserted from the fibula, it is calculated in advance how the elevated bone must be cut so that the anatomical shape of the lower jaw can be reconstructed. If these defects are stored in a database, then the "cutting guides" can be calculated automatically and, in the future, such additional procedures can eliminate the additional X-ray exposure of the donor region, if the statistical model can automatically provide this information as an average value, which is currently assumed is.
• the process chain for manufacturing implants looks like this:
• an automatic reconstruction of the bone surface takes place with 3D data, using existing data from the specific, individual patient, supplemented with data from a static model.
• the combination of the existing (residual) data of the individual patient with the supplementary 3D data from the statistical model therefore leads to a targeted surface reconstruction of the bone to be treated.
• the statistical model of shapes is used for computer-assisted planning.
• the mold model is integrated into the corresponding planning software (eg as an STL data set) and can be used for "virtual reconstruction" in surgical navigation.
• the advantage of this method is that no reflection for the reconstruction must, however, be performed Bilateral (two-sided defects can be navigated.) Simultaneous delivery of the virtual implants allows precise control of the surgical positioning by navigation.
• a standardized implant is already “engineered” for a region, that is, an "average implant” has already been generated using standard means. This is stored in a database. Based on the construction points, this is anchored in the statistical model and automatically placed in the appropriate place of the individual. In a second step, then the surface adaptation of the implant surface, which faces the bone. The design file changes when customizing the statistical shape model to the individual bone.
• Fig. 3 shows the location of a region to be treated on an exemplary skull
• Fig. 4 shows the attachment of bone fasteners, like an orbital implant and a maxillary implant.
• the figures are merely schematic in nature and are only for the understanding of the invention. The same elements are provided with the same reference numerals.
• the invention is suitable for use in cranio-facial surgery, but may ultimately be used on and / or for any bony structure of a human or mammal.
• a method 1 there is a first step 2 of providing original 3D data of a bone or bone portion of a specific patient to be treated. Thereafter, there is a second step 3, in which the inclusion of 3D data of a reference patient selected according to predefined criteria takes place, namely, the 3D data in a comparable area, which is due for treatment, are taken. In a subsequent third step 4, a supplement is added, U.U. comprising trimming, the 3D data combined from step 2 and step 3, wherein in a sub-step a combining of the data takes place.
• a mirroring step 5 can also take place.
• opposed 3D data are taken from the diseased patient to be treated (healthy) to the longitudinal axis or a plane of symmetry containing the longitudinal axis of the body and superimposed on the 3D data of the diseased side to be treated. It is recommended to take this step.
• a bone treatment agent 7 for example in the manner of an implant or a bone cutting template, is manufactured. This also makes possible a "virtual surgical planning.”
• FIG. 3 shows a region 9 to be treated on a skull having a bone 8. While the orbit of this skull on the right side seen from the patient has a defect in the region of the area to be treated 9, the orbit on the left side seen from the patient, no defect.
• the relevant data, the healthy side, are transferred to the defective point in a mirroring step 10 visualized in FIG. They are morphed up / down there. Upstream of the previous steps is a preparation step 1 1, in which the 3D data of the patient and / or the 3D data of one or more reference patients, are recorded in a local or web-based database or these are removed.
• Fig. 2 is pictorially illustrated how, starting from a bone defect landmarks are created, then an "adjustment” takes place, in which a superimposed shape model is used, but this is not yet adapted to then subsequently in a calculation section a statistical shape model To achieve an adapted bone defect replacement model, markers 12 that form the "landmarks" are identified by the reference numeral 12.
• a production step 3 is used in the method 1 according to the invention.

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• 2015
  • 2015-10-27 DE DE102015118318.8A patent/DE102015118318B4/de active Active
• 2016
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