骨模型、骨填充材以及骨填充材的制造方法 Method for producing a bone model, bone filler and a bone filler

技术领域 Technical Field

[0001] 本发明涉及一种骨模型、定制的骨填充材以及定制的骨填充材的制造方法。 [0001] The present invention relates to a bone model, a method for producing a bone filler and custom tailored bone filler. 具体而言，本发明涉及一种可通过其上的等高线、网格图形（位置图）等使模型的高低起伏或非对称性等一目了然的骨模型。 Specifically, the present invention relates to a contour through its on a grid pattern (map) or the like undulating symmetry model at a glance bone model. 本发明还涉及一种骨填充材的制造方法，该方法是指，先通过CT或MRI等将患者的骨的形状数字化，并根据该数字化信息制造骨模型，接下来外科医生将造型材料填充在该模型内，从而形成骨填充材造型，然后，再次将形成的骨填充材造型也数字化，并根据该数字信息来制造骨填充材。 The present invention also relates to a method for producing a bone filler, which means, first by CT or MRI, the patient's bone shape digitized and the digitized information is based on producing a bone model, then the molding material is filled surgeon in within the model, so as to form the shape of a bone filler, then, will again form the shape of a bone filling material is also digitized, and based on the digital information to produce a bone filler. 采用该方法，可制造高精度的骨填充材。 Using this method, it can be produced with high precision bone filling material.

背景技术 Background

[0002] 为了治疗因交通事故等造成骨缺损的患者（骨缺损患者），需要在整形外科等领域进行手术，将人工骨填充在该缺损部分上。 [0002] In order to treat traffic accidents caused by defects in patients with bone (bone defects patient), you need plastic surgery and other areas of surgery, the bone filling defect in the part. 在外科治疗中，有时会将患骨肿瘤等的病变部分切除。 In surgical treatment, we will sometimes suffer from a diseased bone tumors resection. 为了修复该切除的病变部分，需要将骨填充材填补在骨缺损部分上而进行治疗。 In order to repair a lesion of the cutout, you need to fill in the bone filler and bone defect site for treatment. 在进行该治疗时也希望获得与骨缺损部分的形状一致的骨填充材。 During the same shape also hope to get a bone filler and bone defect portion of the treatment time.

[0003] 例如，日本发明专利公开公报特开平7484501号（下述专利文献1)中公开了一种技术：利用X射线CT或MRI的断层影像（断层图像），获得人工颅骨等的内固定部件的插入部位（例如缺损部分）的三维数据，再通过该三维数据来表示该插入部位的三维图像， 同时将内固定部件的图像移动到该三维图像上，从而可在术前模拟内固定部件与插入部位 [0003] For example, Japanese Patent Application Laid-open No. 7,484,501 (Patent Document 1) discloses a technique: the use of tomography (SPECT images) X-ray CT or MRI, access to artificial skull like a fixed member The insertion site (for example, a defect portion) of three-dimensional data, and then to represent the insertion site through the three-dimensional image data, while the image is moved to the fixed part of the three-dimensional image, which can simulate a fixed component in the preoperative and insertion site

的一致性。 Consistency.

[0004] 日本发明专利公报特公平6-2137号（下述专利文献2)中公开了一种装置：禾0用X射线CT或MRI的断层影像，获得人工颅骨等的内固定部件的插入部位的三维数据，并将该三维数据输入切削装置，这样来制造插入部位的复制品（模型）。 [0004] Japanese Unexamined Patent Publication No. 6-2137 equity (Patent Document 2) discloses an apparatus: Wo 0 X-ray CT or MRI tomography, access to insert artificial skull and other parts of the fixation member The three-dimensional data, and cutting the three-dimensional data input device, so to create a replica of the insertion site (model).

[0005] 日本发明专利公开公报特开2003-U6124号（下述专利文献3)中公开了如下技术内容：“一种骨填补材料加工系统，连接三维测量装置和三维加工机，其特征在于，根据所述三维测量装置获得的骨缺损部分的三维形状数据，通过所述三维加工机加工骨填补材料”（权利要求1)。 [0005] Japanese Unexamined Patent Publication No. 2003-U6124 invention No. (Patent Document 3) discloses a technique for text: "A bone filling material processing systems, connecting the three-dimensional measuring device and three-dimensional processing machine, wherein According to the three-dimensional shape data obtained by the three-dimensional measuring apparatus bone defect portion, the fill material through the three-dimensional processing machining bones "(claim 1).

[0006] 日本发明专利公开公报特开2001-9四50号（下述专利文献4)中公开了如下技术内容：“一种填补用人工骨设计系统，其根据人体断层图像设计用于填补骨缺损部分的填补用人工骨，其特征在于，该填补用人工骨设计系统包括：骨部候补区域抽出机构，该机构在互不相同的多个断层位置拍摄的各断层图像中将预设密度级的像素区域抽出，并以此作为骨部候补区域；区域选择机构，其在该骨部候补区域中选择最终用作骨部区域的区域（下面，称为确定骨部区域）；骨部外轮廓线信息生成机构，其根据该确定骨部区域生成骨部外轮廓线信息，该信息是最终应被确定为骨部区域的外轮廓线信息；三维形状数据生成机构， 其根据各断层位置的骨部外轮廓线信息生成所述骨部的缺损部分的三维形状数据”（权利要求1)。 [0006] Japanese Patent Laid-open No. 50 2001-9 four (Patent Document 4) discloses a technique for text: "A design filled with artificial system tomographic images of the human body is designed to fill the bone filled with a bone defect portion, characterized in that the filling with bone design system comprising: a bone candidate area extraction mechanism portion, each tomographic image of the institution will be in a plurality of different positions taken by the preset fault density level pixel region extraction, and as the bone portion candidate area; region selection mechanism is used to select the final regional bone region (hereinafter referred to determine bone region) in the bone portion of the candidate region; the outer contour of the bone section line information generating means which generates a region based on the determination of bone Bone outer contour line information, the information shall be determined as the final outer contour information region of the bone; three-dimensional shape data generating means, according to their respective fault location bone dimensional shape data "defect portion of the outer portion of the bone contour information generation unit (claim 1).

[0007] 日本发明专利公报特许四30420号（下述专利文献5)中公开了如下技术内容： “一种医用设备制造方法，包括用固体自由成型技术来形成聚合物材料连续层的聚合物基 [0007] Japanese Patent Publication Laid-four No. 30420 (Patent Document 5) discloses a technique Content: "A medical device manufacturing method comprising using a solid free forming techniques to form a continuous layer of polymeric material based polymer

4质形成工序”（权利要求1)。 4 mass forming step "(claim 1).

[0008] 此外，国际公开2005-011536号小册子（专下述利文献6)中，公开了一种通过粉末层压法来制造人工骨的方法，该粉末层压法采用了RP装置。 [0008] In addition, International Publication No. 2005-011536 pamphlet (Patent Document 6 below Lee) discloses a method of manufacturing by a powder lamination method of artificial bone, the powder laminating method using RP apparatus.

[0009] 如上所述，下面这种确定骨填充材形状的方法已为人们所知：即，先以某种形式来获得骨缺损部位的形状信息，并通过计算机模拟来假定骨缺损部位的形状，然后根据该假定的骨缺损部位的形状确定骨填充材的形状。 [0009] As described above, following the shape of a bone filler such determination methods have been known: That is, in some form to obtain the first shape information of the bone defect, and by computer simulation to assume the shape of the bone defect and then determine the shape of a bone filler according to the shape of the bone defect site assumes. 但这种方法只是一种根据计算机的推测来确定骨填充材形状的方法。 However, this method is based on a computer to determine the presumed bone filler shape methods. 因此，虽然按这种方法制造的骨填充材的形状大多数与实际的骨缺损部位的形状相一致，但却难以反映医生等手术实施人员的专业技术。 Thus, although the shape of this way of manufacturing bone filling material is consistent with most of the actual shape of the bone defect site, but it is difficult to reflect the implementation of doctors and other professional and technical personnel of the operation. 此外，手术实施人员也是在没有亲身体会的情况下就确定骨填充材的形状，所以难以想象到实际的手术实施情形等。 In addition, the surgical staff also implement in the absence of personal experience would determine the shape of a bone filler, it is hard to imagine the actual situation and other surgical implement.

[0010] 另一方面，日本发明专利公开公报特开平9-154865号（专利文献7)中公开了如下技术内容。 [0010] On the other hand, Japanese Patent Laid-Open (Patent Document 7) No. 9-154865 discloses a technique content. “一种骨缺损部分填补材料的形状确定用夹具，该夹具是用于确定骨缺损部分填补材料的形状并模仿骨体形状的夹具，其特征在于，该夹具由透明材料或半透明材料制成，并形成为沿该骨体部的表面的形状”（权利要求1)；“一种骨缺损部分填补材料的形状确定方法，其特征在于，将形状确定用夹具放在骨体部的缺损部分上，通过该透明的形状确定用夹具来观察与该缺损部分或具有该缺损部分的周边形状适合的状态，并选择最适合的形状确定用夹具，确定对应的骨缺损部分填补材料的形状”（权利要求7)；或者“一种骨缺损部分填补材料的形状确定方法，其特征在于，将按照所述骨缺损部分填补材料的形状确定方法选择出的形状确定用夹具，设置在覆盖所述缺损部分的适当位置上，然后沿着所述缺损部分的轮廓在该形状确定用夹具的表面上画线，并根据该形状确定用夹具上的画线来切割对应的骨缺损部分填补材料，形成填补所述缺损部分的骨缺损部分填补材料”（权利要求8)。 "A bone defect site filling material shape determining jig, the jig is used to determine the shape of the bone defect site filling material and mimic the shape of the jig bone, characterized in that the fixture is made of transparent material or translucent material , and is formed along the shape of the surface of the bone body part "(claim 1);" A bone defect site filling material shape determining method, wherein the shape determining jig on the body portion of the bone defect portion on, determined by the shape of the transparent jig to observe the defects or has a peripheral shape of the defect portion suitable state, and choose the most suitable shape determining jig, determining bone defect portion corresponding to the shape of the material to fill "( Claim 7); or "a portion of bone defect filling material shape determining method, wherein the method of determining the selected shape determining jig, provided covering the defect portion according to the bone defect filling material shape part of the place, and then determine the defect portion along the contour in the shape of the upper surface of the fixture draw lines, and based on the shape determined by drawing a line on the jig to cut the bone defect portion corresponding fill material, form filling bone defect portion of the padding material defects "(claim 8).

[0011] 上述专利文献7所公开的发明的要点是，将透明或半透明的骨缺损部分填补材料的形状确定用夹具放置在缺损部分上，并从多个样式的夹具中选择最适合的夹具，然后根据最适合的透明夹具推定缺损部分的形状，并在该夹具的表面上画线（【0013】自然段），然后切割夹具，由此获得与缺损部分的形状适合的骨填充材板【0014】段。 [0011] Patent Document 7 points above disclosed invention is that the bone defect filled partially transparent or translucent material, shape determining jig placed on the defect site and select the most suitable jig jig from multiple style and according to the most appropriate shape of the transparent defect portion estimating jig, and the jig on the surface of objects (paragraph [0013]), and then cutting jig, thereby obtaining the shape of the defect portion suitable bone filler plate [ 0014] section.

[0012] 通过采用该方法，能将外科医生的技术能力反映在骨填充材上的可能性较高。 High possibility [0012] By adopting this method, the surgeon can be reflected in the technical capability of the bone filler. 但该方法只是一种将透明夹具放置在缺损部分上来推测缺损部分形状的方法。 However, this method only in missing portions of the defect, presumably part of a method of placing shape transparent fixture. 因此，骨填充材的形状是否适合缺损部分，大多数情况下是根据外科医生的经验来决定的，从而，并非总是能获得形状适合的骨填充材。 Thus, the shape of a bone filler is suitable defect portion, in most cases are based on the experience of the surgeon to decide, thus, are not always able to obtain a shape suitable bone filler.

[0013] 此外，上述现有技术还存在骨变形患者等其特定部位的骨形状变形，骨对称性较差的问题。 [0013] In addition, the above-described prior art there are patients with bone deformation, etc. of the specific portion of its deformed shape of the bone, the bone is poor symmetry problem. 因此，为了修复其对称性，需要在凹陷部位设置骨填充材。 Therefore, in order to repair its symmetry, the need for bone filling material in the recessed area. 因此，难以制造形状适合的骨填充材。 Therefore, difficult to produce a shape suitable bone filler.

[0014] 在现有技术的形成外科或美容整形领域，是通过削骨获得想要的骨结构，并将硅、 脂肪团（力>，4卜）等插入特定部位来实施对面部整形等。 [0014] in the form of surgical or cosmetic surgery of the art is to obtain bone structure desired by Xiaogu and silicon, cellulite (power> 4 BU), etc., into specific parts to the implementation of the facial shaping. 但是，当植入硅等非自身物质时，不仅需要很多免疫抑制剂，并且，因为植入的物质对身体来说总是非自身物质，所以还需要定期检查。 However, when implanted in non-self material such as silicon, not only it requires a lot of immunosuppressants, and as implant material for the body is always non-self substance, so it needs to be checked regularly. 此外，还可能因身体不适应植入的硅等物质而引发炎症。 In addition, it may be due to physical discomfort implanted silicon and other substances which cause inflammation.

[0015] 通常情况下，骨填充材的强度较弱，所以当来自外部的撞击或较强的力作用到其上时，该骨填充材则会损坏。 [0015] In general, the intensity of the bone filling material is weak, so when the impact or strong force from the outside to its, the bone filler may be damaged. 此外，因骨填充材并不是患者的骨，所以即使将骨填充材植入骨缺损部分，在外力作用到其上时，该骨填充材也可能会脱落。 In addition, due to the patient's bone is not a bone filling material, so even if the bone filling material implanted bone deficit, the external force to it, the bone filler may also fall off.

[0016] 虽然骨变形症等患者通过目视就能确定骨变形情况，但却难以获知骨出现了何种程度变形的客观信息。 [0016] Although psychosis in patients with bone deformation can be determined by visual bone deformation, bone but it is difficult to know to what extent there has been distortion of objective information. 尤其是在骨变形症的治疗、整形外科或整容外科等方面，不能客观地了解手术前后外观（例如，面部表面的起伏等）出现了何种程度变化。 Especially in the treatment of bone deformation disease, plastic surgery or cosmetic surgery, etc., can not objectively understand the appearance before and after surgery (for example, undulating facial surfaces, etc.) appear what degree of change.

[0017] 专利文献1 ：特开平7484501号公报 [0017] Patent Document 1: JP 7484501 Publication

[0018] 专利文献2 ：特公平6-2137号公报 [0018] Patent Document 2: Patent Publication No. 6-2137 fair

[0019] 专利文献3 ：特开2003-U6124号公报 [0019] Patent Document 3: Unexamined Patent Publication No. 2003-U6124

[0020] 专利文献4 ：特开2001_拟950号公报 [0020] Patent Document 4: JP 2001_ intends Publication No. 950

[0021] 专利文献5 ：特许第四30420号公报 [0021] Patent Document 5: Chartered fourth Gazette No. 30420

[0022] 专利文献6 ：国际公开2005-011536号小册子 [0022] Patent Document 6: International Publication No. 2005-011536 pamphlet

[0023] 专利文献7 ：特开平9-154865号公报 [0023] Patent Document 7: JP-A-9-154865 Gazette

发明内容 DISCLOSURE

[0024] 因此，本发明的目的在于提供一种可确定患者等的骨变形情况的骨模型。 [0024] Accordingly, the object of the present invention is to provide a bone model can be determined such as a patient's bone deformation.

[0025] 本发明的另一目的在于提供一种骨填充材的制造方法，采用该方法可制造用于填充骨缺损部分的高精度骨填充材。 [0025] It is another object of the present invention to provide a method for producing a bone filler, bone filler with high precision manufacturing method can be used to fill the bone defect portion.

[0026] 本发明的另一目的在于提供一种骨填充材的制造方法，采用该方法可有效地修正骨变形（骨对称性较差等）。 [0026] It is another object of the present invention to provide a method for producing a bone filler, this method can effectively correcting bone deformation (bone poor symmetry).

[0027] 本发明的另一目的在于提供一种既能防止骨填充材受外部撞击又能体现骨填充材形状的形状适当的石膏制造方法。 [0027] It is another object of the present invention is to provide a bone filler can prevent external shock but also by the shape of the bone filling material reflects the shape of the appropriate method for producing gypsum.

[0028] 本发明的另一目的在于提供一种外观模型，该外观模型能客观地表示患骨变形疾病等患者其特定部位的外观出现了何种程度的变形。 [0028] It is another object of the present invention is to provide an appearance model, the appearance model can be objectively represented patients suffering from bone diseases, deformation of the appearance of its specific portion of the extent of deformation appears. 本发明还提供一种外观模型及其制造方法，其能在外科等手术中表现出外观在手术前后出现了何种程度的变化。 The present invention also provides a method of manufacturing the appearance of the model, which can show in surgery and other surgery in physical appearance to what extent changes before and after surgery.

[0029] 现有技术中，赝复体是根据生产者的经验来制造的，所以制得的赝复体会根据生产者的熟练程度的不同而出现较大差异。 [0029] The prior art prosthesis is manufactured based on the experience of producers, so prostheses experience obtained while a larger difference depending on the proficiency of the producers. 也有可能制得的赝复体左右不对称而出现外观不合适的问题。 It is possible to obtain a prosthesis emergence of asymmetrical appearance of improper questions. 例如在制造面部上某部位的赝复体时，会将印模材料设置在患者的该部位上来获取该部位的模型，因此对患者来说是比较痛苦的。 For example, in the manufacture of facial prosthesis when certain parts of the impression material will be provided at the site of the patient to get the site up model, so the patient it is more painful. 有鉴于此，本发明的目的在于提供一种对称性好且对患者来说痛苦较少的赝复体制造方法，或赝复体制造用铸模的制造方法。 In view of this, the present invention is to provide a good symmetry and less painful for the patient prosthesis manufacturing method, or prosthesis fabrication method for producing a mold.

[0030] 若完全根据模拟信息来制造骨填充材，则与根据外科医生的经验来制造骨填充材的方法没有什么不同，制得的骨填充材的精度会根据外科医生的熟练程度的不同而出现较大变化。 [0030] If the information is completely based on the simulation of manufacturing bone filler, there is no method in accordance with the experience of the surgeon to make a bone filler different accuracy obtained bone filler will vary according to the surgeon's proficiency and larger change. 此外，若完全只根据数字信息来制造骨填充材，则难以将基于外科医生经验的专业技术反映在获得的骨填充材中。 In addition, if exclusively based on digital information to produce a bone filler, it is difficult to experience-based surgeon expertise is reflected in the bone filler obtained. 因此，本发明基于如下观点而作出：在优选采用数字信息来进行处理的工序中，采用数字信息来进行处理，并且，将环境设计成易于反映外科医生专业技术的环境，从而模拟地反应出外科医生的专业技术，这样，可制造出精度极高的骨填充材。 Accordingly, the present invention is made based on the following ideas: In a preferred use of the digital information processing step, the use of the digital information to be processed, and will be designed to be easy to reflect environmental surgeon technical environment, so as to simulate the reaction of Surgery The doctor's expertise, so can be manufactured highly accurate bone filler.

[0031] 本发明尤其是基于如下观点而作出：在患者的骨模型上描绘等高线或网格图案， 这样可确定患者的骨变形情况或非对称性。 [0031] In particular, the present invention is made based on the following ideas: drawing contour lines or grid patterns on a patient's bone model, the bone can be determined so that the deformation of the non-symmetry of the patient. 本发明还基于如下观点而作出：设置用于填补该被确定的变形的造型材料，并根据该造型材料获得适当形状的骨填充材，由此可获得具有适当形状的骨填充材。 The present invention is also based on the view made: Sets the fill material of the deformed shape is determined, and based on the shape of the molding material to obtain adequate bone filling material, thus obtained bone filling material having appropriate shape. [0032] 本发明涉及一种能制造高精确度骨填充材的骨填充材制造方法，该方法大致为： 先制造患者定制的骨模型，外科医生采用该模型将造型材料填充在缺损部分上，以形成骨填充材造型，然后利用该形成的骨填充材造型来制造骨填充材。 [0032] The present invention relates to a method for producing a bone filler producing highly accurate bone filler, which is substantially as follows: first create customized patient bone model, the surgeon uses the model-forming material filling the defect site, to form the shape of a bone filler, bone filler and then use the shape of the formed bone filler produced.

[0033] 本发明还基于下述观点而作出：通过CT等将患者的骨形状数字化，根据该数字化信息制造例如描绘有等高线或网格图案的骨模型，外科医生根据该模型上描绘的线来确定患者的骨的变形，并填充用于修补变形的造型材料，从而形成骨填充材造型，然后将该形成的骨填充材造型也数字化，并根据该数字信息来制造骨填充材，这样可获得具有适当形状的骨填充材。 [0033] The present invention is also based on the view made: by the patient's bone CT and other digitized form, based on the manufacture of digital information such as bone model depicting contour lines or grid pattern, according to the surgeon on the model depicted line to determine a patient's deformed bone, for repair and filling the molding material deformation, so as to form the shape of a bone filler, the bone formation and filler shape is also digitized, and the digital information is produced based on the bone filler, and having an appropriate shape can be obtained bone filler.

[0034] 本发明技术方案1涉及一种骨填充材的制造方法，包括如下工序：骨数字信息获得工序：对患者的特定部位拍照，获得所述患者特定部位的骨的数字信息，该信息中包括多个骨的剖视图；骨模型制造工序：根据在所述骨数字信息获得工序中获得的包括多个骨的剖视图的数字信息，制造所述患者特定部位的骨模型；造型材料设置工序：对骨模型制造工序中所制造的骨模型设置造型材料；造型材料数字信息获得工序：对在造型材料设置工序中设置有造型材料的骨模型拍照，获得造型材料的数字信息；骨填充材制造工序：根据在所述造型材料数字信息获得工序中获得的造型材料的数字信息，制造骨填充材。 [0034] one aspect of the present invention relates to a method for producing a bone filler, comprising the steps of: bone digital information obtaining step of: photographing a specific part of the patient, the patient-specific portion of the obtained bone digital information, the information a cross-sectional view includes a plurality of bone; bone model producing step: According bone digital information including a plurality of cross-sectional view of the obtained bone digital information obtained at the step, the bone model producing specific part of the patient; forming material setting step: on bone model produced in the manufacturing process of setting bone model modeling material; molding material digital information obtaining step: to set the molding material is provided in the step of molding material bone model camera, access to digital information modeling materials; bone filler manufacturing process: According to information obtained digital information obtained in the step-forming material in the shape of digital material, producing a bone filling material. 即，优选以数字式进行的模型形成工序、像成形后制造骨填充材的工序等工序是根据数字信息而进行的。 That is, it is preferable to perform the digital model forming step, after forming as a bone filler producing step processes are carried out according to digital information. 另一方面，本发明是在设计了一种易于反映出外科医生专业技术的环境后，如在骨模型上描绘等高线，通过外科医生在骨模型上设置造型材料，来模拟性地反映外科医生的专业技术，这样，可制造出精确度较高的骨填充材。 On the other hand, the present invention is designed to reflect the surgeon after an easy professional environment, such as contour lines are drawn on the bone model, set up by the surgeon-forming material on the bone model to simulate sexual reflect Surgery The doctor's expertise, so that a high accuracy can be produced bone filler.

[0035] 对于上述骨填充材的制造方法，其优选实施方式为，对所述患者的特定部位进行拍照的工序是通过CT扫描或MRI来获得骨数字信息的工序，该信息中包括所述患者特定部位的多个骨的剖视图；所述造型材料数字信息获得工序是通过CT扫描或MRI来获得造型材料的数字信息的工序。 [0035] For the above-described method for producing a bone filler, a preferred embodiment thereof, a specific portion of the patient is a step of photographing the bone digital information obtaining step by CT scan or MRI, this information includes the patient sectional view of a specific portion of a plurality of bone; the forming material digital information obtaining step is a step of obtaining digital information of figure-forming material by a CT scan or MRI. 即，通过采用CT扫描或MRI，能比较容易地获得多个包括骨或造型材料的造型的剖视图。 That is, by using CT scan or MRI, can more easily include a plurality of cross-sectional view of the bone or the shape of molding material gain. 通过采用该CT拍摄到的图像或MRI图像，能通过计算机等容易地获得骨或造型材料的三维数字信息。 By using the CT or MRI image captured images via computer and other easily obtained three-dimensional digital bone-forming material or information. 对于上述任意一种骨填充材的制造方法，其优选实施方式为，所述患者特定部位是指患者的颅骨、下颚部分、上颚部分、四肢或骨盆中之一的部位。 For any of the above-described method for producing a bone filler, a preferred embodiment thereof, refers to the portion of the patient specific patient skull, jaw portions, the upper jaw portion parts, one of the limbs or pelvis. 这些部位均为左右对称的结构，所以能够比较容易地确定出变形情况。 These parts are symmetrical configuration, it is possible to relatively easily determine deformation.

[0036] 对于上述任意一种骨填充材的制造方法，其优选实施方式为，在所述骨模型制造工序中制造的骨模型是描绘有等高线或网格图案的骨模型。 [0036] For any of the above-described method of manufacturing a bone filler, a preferred embodiment thereof, the bone model produced in the bone model producing step has contour lines or grid patterns bone model. 通过在骨模型上描绘等高线或网格图案，外科医生可根据获得的骨模型，在设置造型材料时，极其容易地确定出骨的变形、凹陷等情况，因此，可获得精确度较高的骨填充材。 By depicting contour lines or grid pattern on the bone model, the bone model based on the surgeon can get when setting modeling material, very easily determine bone deformation, dents, etc., therefore, obtain higher precision The bone filler.

[0037] 对于上述任意一种骨填充材的制造方法，其优选实施方式为，在所述骨模型制造工序中制造的骨模型是含有石膏的骨模型。 [0037] For any of the above-described method of manufacturing a bone filler, a preferred embodiment thereof, the bone model produced in the bone model producing step is a bone model containing gypsum. 对于上述任意一种骨填充材的制造方法，其优选实施方式为，所述骨模型制造工序是通过快速原型法、注塑成型法、由切割产生的层压成型法或采用具有加工中心（带有刀具库和自动换刀装置的数控机床）的加工装置的成型法来制造骨模型的工序。 For any of the above-described method for producing a bone filler, a preferred embodiment thereof, the bone model producing step by the rapid prototype method, injection molding method, a lamination molding method produced by the cutting or the use of having a machining center (with CNC machine tool magazine and automatic tool changer) processing apparatus to the manufacturing process of molding bone model. 如果骨模型是以石膏作为主要成分，就能通过下述任意一种成型法比较容易地制造出骨模型：快速原型法；注塑成型法，根据CT扫描或MRI等拍摄的骨数字信息设计模具，并利用该模具来制造骨模型；根据获得的骨的数字信息，采用具有加工中心的加工装置的成型法；根据获得的骨的数字信息，利用具有多轴钻床并可进行NC控制的成型法。 If the bone is a plaster model as a main component, can be formed by any one of the following method is relatively easy to produce bone model: Rapid Prototyping; injection molding method, based on CT scan or MRI of bone digital information such as shooting mold design, and using the mold to produce a bone model; based on the obtained bone digital information, the use of having a machining center processing apparatus forming method; according to the obtained bone digital information, the use of multi-axis NC drilling machines and can be controlled molding.

[0038] 对于上述任意一种骨填充材的制造方法，其优选实施方式为，在所述骨模型制造工序中制造的骨模型是如下一种骨模型：含有钙类物质和聚乙烯醇树脂，当所述钙类物质和所述聚乙烯醇树脂的总重量为100重量份时，所述聚乙烯醇树脂的重量份为2重量份〜8 重量份。 [0038] For any of the above-described method for producing a bone filler, a preferred embodiment thereof, the bone model produced in the bone model producing step is a bone model as follows: calcium-based material and polyvinyl alcohol resin containing, When the total weight of the calcium-based material and the polyvinyl alcohol resin is 100 parts by weight, the parts by weight of the polyvinyl alcohol resin is 2 parts by weight of ~ 8 parts by weight. 通过所述各种成型法尤其是注塑成型法，能够非常快地获得高精确度的骨模型， 所以，采用这种骨模型能制造出高精确度的骨填充材。 The various molding methods by injection molding in particular, can very quickly obtain highly accurate bone model, therefore, the use of such a bone model can produce highly accurate bone filler. 对于上述任意一种骨填充材的制造方法，其优选实施方式为，在所述骨模型制造工序中制造的骨模型是如下一种骨模型：以含有α型半水石膏和聚乙烯醇树脂的组合物为原料，当所述钙类物质和所述聚乙烯醇树脂的总重量为100重量份时，所述聚乙烯醇树脂的重量份为2重量份〜8重量份。 For any of the above method for producing a bone filling material, which is a preferred embodiment of the bone model produced in the bone model producing step is a bone model as follows: containing α-hemihydrate gypsum and polyvinyl alcohol resin The composition of the raw material, when the total weight of the calcium-based material and the polyvinyl alcohol resin is 100 parts by weight, the parts by weight of the polyvinyl alcohol resin is 2 parts by weight of ~ 8 parts by weight.

[0039] 对于上述任意一种骨填充材的制造方法，其优选实施方式为，所述骨模型以石膏为主要成分，所述造型材料含有总重量的90重量％以上的蜡或塑料。 [0039] For any of the above-described method of manufacturing a bone filler, a preferred embodiment thereof, the bone model contains gypsum as the main ingredient, the total weight of the molding material contains 90 wt% or more of a wax or plastic. 对于上述任意一种骨填充材的制造方法，其优选实施方式为，所述骨模型以石膏为主要成分，所述造型材料含有总重量的90重量％以上的蜡。 For any of the above-described method for producing a bone filler, a preferred embodiment thereof, the bone model contains gypsum as the main ingredient, the total weight of the molding material contains 90 wt% or more of wax. 对于上述任意一种骨填充材的制造方法，其优选实施方式为，所述骨模型以石膏为主要成分，所述造型材料含有总重量的90重量％以上的蜡，还含有总重量的2重量％以上且5重量％以下的金红石型氧化钛。 For any of the above-described method for producing a bone filler, a preferred embodiment thereof, the bone model contains gypsum as the main ingredient, the total weight of the molding material contains 90 wt% or more of a wax, further comprising by weight of the total weight of 2 % or more and 5% by weight of rutile titanium oxide. 即，通过CT扫描或MRI等拍摄具有这种成分的骨模型和造型材料，可精确地分析出骨模型部分和造型材料部分，所以能制造高精度的骨填充材。 That is, by CT scan or MRI and other shooting material having a bone model and style of this ingredient, can accurately analyze the bone part of the model and modeling material portion, it is possible to manufacture high precision bone filler.

[0040] 对于上述任意一种骨填充材的制造方法，其优选实施方式为，所述骨填充材制造工序是通过快速原型法制造骨填充材的工序。 [0040] For any of the above-described method of manufacturing a bone filler, a preferred embodiment thereof, the bone filler producing step is a step by the rapid prototype method step for producing a bone filling material. 通过采用快速原型法，可快速、精确地制造定制的骨填充材。 By using rapid prototyping, you can quickly and accurately manufacture custom bone filler.

[0041] 对于上述任意一种骨填充材的制造方法，其优选实施方式为，在所述骨填充材制造工序中获得的骨填充材是采用羟基磷灰石、碳酸磷灰石、氟磷灰石、氯磷灰石、β -TCP、 α-TCP、偏磷酸钙、磷酸四钙、磷酸八钙、磷酸氢钙、磷酸二氢钙、焦磷酸钙、它们的盐或溶剂化物中任意一种或任意两种以上制成。 [0041] For any of the above-described method for producing a bone filler, a preferred embodiment thereof, a bone filler obtained in the bone filler producing step is the use of hydroxyapatite, carbonate apatite, fluorine apatite Stone, chlorine apatite, β -TCP, α-TCP, calcium metaphosphate, tetracalcium phosphate, octacalcium phosphate, calcium hydrogen phosphate, calcium dihydrogen phosphate, calcium pyrophosphate, salts thereof, or any solvate or any two or more thereof. 当通过如注塑成型法利用上述原制造骨填充材时， 会在成型时出现相变，变成具有更好特长的骨填充材。 When such as by injection molding method using the raw bone filler is produced, there will be a phase change in the molding into bone filler has better expertise.

[0042] 本发明还涉及一种描绘有等高线或网格图案的骨模型。 [0042] The present invention further relates to a kind of contour lines or grid patterns depicted bone model. 由于骨模型上描绘有等高线或网格图形（格状线），所以能够比较容易地确定骨模型的变形情况。 Since there is depicted contour lines or grid patterns (trellis) on the bone model, it is possible to more easily determine the deformation of a bone model.

[0043] 对于上述骨模型，其优选实施方式为，所述骨模型是再现有患者特定部位的骨形状的模型。 [0043] For the above-described bone model which is a preferred embodiment, the bone model is a reproduction of a bone shape of a patient specific model of the site. 对于上述骨模型，其优选实施方式为，所述骨模型是再现有患者颅骨的骨形状的模型。 For the above-described bone model which is a preferred embodiment, the bone model is a reproduction of a bone shape of a patient's skull model. 即，当骨模型是患者定制的骨模型时，可正确地确定该患者的骨变形情况。 That is, when the bone model is customized patient bone model, you can accurately determine the patient's bone deformation. 因此，这种骨模型在恰当地确定骨填充材的形状方面也是非常有效的，采用该骨模型能获得形状更适宜的骨填充材。 Therefore, this bone model appropriately determined in terms of the shape of a bone filler is very effective, using the bone model can be obtained more suitably shaped bone filling material.

[0044] 本发明还涉及一种骨填充材的制造方法，其大致包括如下工序。 [0044] The present invention further relates to a method for producing a bone filler, which substantially comprises the following steps. 骨模型制造工序： 制造骨模型；造型材料填充工序：将造型材料填充在所述骨模型制造工序中获得的骨模型的骨缺损部分上；骨填充材制造工序：根据所述造型材料填充工序中填充在骨模型的骨缺损部分上的造型材料，制造用于填充骨缺损部分的骨填充材。 The bone model producing step: producing a bone model; forming material filling step: The molding material filling the bone defect site of the bone model obtained in the bone model producing step; bone filler producing step: According to the molding material filling step filling the bone defect site of the bone model modeling materials, manufacturing for the bone filler filling bone defect portion.

[0045] 对于上述任意一种骨填充材的制造方法，其优选实施方式为，所述骨模型制造工序是通过快速原型法制造骨模型的工序。 [0045] For any of the above-described method for producing a bone filler, a preferred embodiment thereof, the bone model producing step is a step by the rapid prototype method for producing a bone model. 通过采用快速原型法，可快速、精确地制造例如部分骨缺损的患者的骨模型。 By using rapid prototyping, it can quickly and accurately model the manufacturing part of the bone such as bone defect patients. 对于上述任意一种骨填充材的制造方法，其优选实施方式为，骨 For any of the above-described method for producing a bone filler, a preferred embodiment thereof, the bone

8模型制造工序中制造的所述骨模型是描绘有等高线或网格图案的骨模型。 8 the bone model produced in the model producing step has contour lines or grid patterns bone model. 即，采用这种骨模型，可准确确定患者的骨变形，所以可制造适于患者的骨填充材。 That is, using this bone model can accurately determine the patient's bone deformation, it can be manufactured adapted to the patient's bone filler.

[0046] 对于上述任意一种骨填充材的制造方法，其优选实施方式为，所述造型材料填充工序中所采用的造型材料是X射线透过率、红外线透过率或紫外线透过率与所述骨模型不同的造型材料。 [0046] For any of the above-described method of manufacturing a bone filler, a preferred embodiment thereof, the molding material-forming material filling step employed in the X-ray transmittance, ultraviolet transmittance and infrared transmittance, or The bone model material different shapes. 由于造型材料的X射线透过率、红外线透过率或紫外线透过率与所述骨模型不同，所以能在骨模型上固定有造型材料的状态下分析造型材料的形状。 Because of the shape of the shape of the material under the X-ray transmission modeling materials, infrared transmittance or ultraviolet transmittance of the bone model is different, so the model can be fixed to the bone-forming material state analysis. 由此，能防止骨缺损部分的形状因如下原因而不能准确地确定：即，在从骨模型取出造型材料时，造型材料的形状改变或造型材料的一部分残留在骨模型上。 This makes it possible to prevent the shape of the bone defect part due the following reasons can not be accurately determined: that, in the shape of the material removed from the bone model, modeling material change in shape or the shape of the material remains in the bone part of the model.

[0047] 对于上述任意一种骨填充材的制造方法，其优选实施方式为，所述造型材料填充工序中所采用的造型材料含有总重量的2重量％以上且5重量％以下的金红石型氧化钛。 [0047] For any of the above-described method for producing a bone filler, a preferred embodiment thereof, the molding material-forming material filling step employed in the total weight of contained 2% by weight or more and 5% or less by weight rutile type oxide titanium. 通过含有金红石型氧化钛，可利用X射线CT等区分出造型材料和骨模型。 By containing rutile titanium oxide, etc. can be used to distinguish the X-ray CT and bone model modeling material.

[0048] 对于上述任意一种骨填充材的制造方法，其优选实施方式为，所述骨模型制造工序中制造的骨模型以石膏为主要成分，所述造型材料填充工序中所采用的造型材料含有总重量的90重量％以上的蜡，还含有总重量的2重量％以上且5重量％以下的金红石型氧化钛。 [0048] For any of the above-described method of manufacturing a bone filler, a preferred embodiment thereof, the bone model produced in the bone model producing step of gypsum as a main component, the molding material-forming material filling step employed containing 90 wt% or more of the total weight of the wax, further comprising the total weight of 2 wt% or more and 5 wt% or less of the rutile-type titanium oxide. 通过含有金红石型氧化钛，可利用X射线CT等区分出造型材料和骨模型。 By containing rutile titanium oxide, etc. can be used to distinguish the X-ray CT and bone model modeling material.

[0049] 对于上述任意一种骨填充材的制造方法，其优选实施方式为，所述骨填充材制造工序是通过快速原型法制造骨填充材的工序。 [0049] For any of the above-described method of manufacturing a bone filler, a preferred embodiment thereof, the bone filler producing step is a step by the rapid prototype method step for producing a bone filling material. 即，通过X射线CT等获得骨缺损部分的形状信息，所以可通过快速原型法填充材迅速、精确地制造骨填充材。 That is, by X-ray CT and other information to obtain the shape of the bone defect portion, it is possible filler by the rapid prototype method quickly and accurately producing a bone filling material.

[0050] 对于上述任意一种骨填充材的制造方法，其优选实施方式为，所述骨填充材制造工序具有如下工序。 [0050] For any of the above-described method of manufacturing a bone filler, a preferred embodiment thereof, the bone filler producing step comprises the following steps. 混炼工序：对具有钙类物质的原材料和具有粘结剂的材料进行混炼的工序；成型工序：采用具有模具的注塑成型机，通过注塑成型法将在所述混炼工序中获得的混炼物形成具有规定形状的成型体；粘结剂去除（脱脂）工序：用于去除所述成型工序中获得的成型体中所含的粘结剂，获得脱脂体；烧结工序：对所述粘结剂去除工序中获得的脱脂体加热并烧结，以获得烧结体。 Kneading step: raw materials have calcium-based material and a material having a binder kneading step; forming step: a mold using an injection molding machine, mixing by injection molding obtained in the kneading step refining was formed to have a predetermined molded shape; binder removal (degreasing) step: step for forming an adhesive removing said molded article obtained contained, obtained degreased body; sintering step: on the stick caking agent removing step degreased body was heated and sintered to obtain a sintered body. 通过采用X射线CT等获得骨缺损部分的形状信息， 可利用该形状信息制得模具，并制造具有准确形状的骨填充材。 By using the obtained X-ray CT and other bone defect portion shape information, the shape information can be used to prepare a mold, and producing a bone filler having an accurate shape.

[0051] 对于上述任意一种骨填充材的制造方法，其优选实施方式为，具有将如下药剂浸渍在所述骨填充材制造工序中获得的骨填充材中或涂敷在其上的工序，即，骨或软骨形成促进剂、关节疾病治疗剂、骨或软骨疾病预防剂、骨或软骨疾病治疗剂、骨再生剂、骨吸收抑制剂、血管新生促进剂、抗菌剂、抗生素或抗癌剂。 [0051] For any of the above-described method for producing a bone filler, a preferred embodiment thereof, having a bone filler or coating agent are impregnated in the obtained bone filler producing step is a step thereon, i.e., bone or cartilage formation promoting agent, a joint disease therapeutic agent, a bone or cartilage disease preventive agent, a therapeutic agent of bone or cartilage disease, bone regeneration agents, bone resorption inhibitors, angiogenesis promoter, an antibacterial agent, antibiotic or anti-cancer agents . 由于将规定药剂浸渍在骨填充材中或涂敷在其上，所以可提供具有多种药效的骨填充材。 Since the provisions of dipping or coating agent in bone filler on its, bone filler can be provided with a variety of efficacy.

[0052] 本发明还涉及另一种骨填充材的制造方法，该方法包括如下工序。 [0052] The present invention further relates to another method for producing a bone filler, the method comprising the following steps. 制造骨模型的骨模型制造工序；造型材料设置工序：对所述骨模型制造工序中获得的骨模型设置造型材料；骨填充材制造工序：根据所述造型材料设置工序中设置在骨模型上的造型材料，制造骨填充材。 Producing a bone model of bone model producing step; molding material is provided the steps of: setting a model of the bone-forming material on the bone model producing step; the bone filler producing step: molding material is arranged according to the process set up in the bone model modeling materials, manufacturing bone filler. 造型材料设置工序优选对所述骨模型制造工序中获得的骨模型设置造型材料， 以修正骨模型的非对称性。 Setting bone model modeling material modeling material is placed on the bone model process is preferably obtained in the manufacturing process to correct the asymmetry of the bone model. 这样，可获得能修正骨变形的骨填充材。 This can be corrected bone filler obtained bone deformation.

[0053] 对于该骨填充材的制造方法，其优选实施方式为，所述骨模型制造工序中获得的骨模型是描绘有等高线或网格图案的骨模型。 [0053] The method for producing the bone filling material, which is a preferred embodiment, the bone model obtained in the bone model producing step has contour lines that depict a pattern or grid bone model.

[0054] 对于上述任意一种骨填充材的制造方法，其优选实施方式为，所述造型材料设置工序中所采用的造型材料是X射线透过率、红外线透过率或紫外线透过率与所述骨模型不同的造型材料。 [0054] For any of the above-described method of manufacturing a bone filler, a preferred embodiment thereof, the molding material forming material setting step is used in X-ray transmittance, ultraviolet transmittance and infrared transmittance, or The bone model material different shapes. 对于上述任意一种骨填充材的制造方法，其优选实施方式为，骨模型是骨缺损患者、骨变形患者或美容整形患者的骨模型。 For any of the above method for producing a bone filling material, which is a preferred embodiment of the bone model is a bone defect in patients with bone model of bone deformation cosmetic surgery patients or patients.

[0055] 本发明还涉及一种骨填充材和石膏托的制造方法，该方法包括如下工序。 [0055] The present invention also relates to a method for producing a bone filler and plaster, the method comprising the steps of. 即，骨数字信息获得工序：对患者的特定部位拍照，获得所述患者特定部位的骨的数字信息，该信息中包括多个骨的剖视图；骨模型制造工序：根据在所述骨数字信息获得工序中获得的具有多个骨的剖视图的数字信息，制造所述患者特定部位的骨模型；造型材料设置工序：对所述骨模型制造工序中制造的骨模型设置骨填充用的造型材料和石膏托形成用的造型材料， 该石膏托形成用的造型材料的材料与所述骨填充用的造型材料的材料不同；造型材料数字信息获得工序：对在所述造型材料设置工序中设置有造型材料的骨模型拍照，获得造型材料的数字信息；骨填充材和石膏托制造工序：根据在所述造型材料数字信息获得工序中获得的造型材料的数字信息，制造骨填充材和石膏托。 I.e., bone digital information obtaining step of: photographing a specific part of the patient, obtaining the patient's bone specific portion of digital information, a plurality of cross-sectional view of the information included in the bone; bone model producing step: based on the obtained bone digital information in the the digital information having a cross-sectional view of the step of obtaining a plurality of the bone, producing patient specific part of the bone model; step molding material is arranged: the bone model produced in the bone model producing step is provided with the shape of the bone filling material and gypsum entrusted with forming a molding material, the plaster material is formed of different materials and the use of bone-forming material is filled with the molding material; molding material digital information obtaining step: to set the molding material is provided in the molding material in step The bone model pictures, access to digital information modeling materials; bone filler and plaster manufacturing processes: according to the molding material digital information obtaining step of obtaining digital information modeling materials, manufacture bone filler and plaster.

[0056] 通过采用上述骨填充材和石膏托的制造方法，可获得适于患者的骨填充材，还可设计能适当支承该骨填充材的石膏托。 [0056] By adopting the above method for producing a bone filler and plaster, and get adapted to the patient's bone filler, it can also be designed to properly support the plaster of the bone filler. 由于石膏托形成用的造型材料中含有与所述骨填充材用的造型形成材料不同的材料，所以在通过CT扫描或MRI等拍照时，可区分出二者的形状。 Since the formation of the plaster molding material contained in the bone filling material is formed by the shape of a different material, so when by CT scan or MRI and other camera, you can distinguish between the two shapes.

[0057] 本发明还涉及一种石膏托的制造方法，该方法包括如下工序。 [0057] The present invention also relates to a method for producing a plaster, the method comprising the steps of. 即，骨和软组织的数字信息获得工序：对患者的特定部位拍照，获得所述患者特定部位的骨的数字信息，该信息中具有多个骨的剖视图，还获得所述骨周围的软组织的相关数字信息；石膏托制造工序： 根据在所述骨和软组织的数字信息获得工序中获得的具有多个骨和软组织的剖视图的数字信息，制造所述患者特定部位的石膏托。 I.e., bone and soft tissue digital information obtaining step of: photographing a specific part of the patient, obtaining the patient's bone specific portion of digital information, the information having a cross-sectional view of a plurality of bone, but also to obtain the relevant soft tissue around the bone digital information; plaster manufacturing process: a cross-sectional view according to the digital information having a plurality of bone and soft tissue in the digital information of the bone and soft tissue obtained in the obtaining step, patient-specific parts of the plaster manufacturing said. 由于是根据所述软组织的数字信息来制造石膏托，所以可制造形状适于患者的定制石膏托。 Because it is based on the digital information of the soft tissue to produce plaster, it is possible to manufacture custom shaped to the patient plaster. 就本发明的骨填充材和石膏托的制造方法和石膏托的制造方法而言，可采用前述的骨填充材制造方法的优选实施方式和组成。 On the bone filling material of the present invention and the manufacturing method and the method of plaster of plaster, the preferred embodiment of the aforementioned bone filler may be a method of manufacturing and composition.

[0058] 本发明还涉及一种描绘有等高线或网格图案的身体某特定部位的外观模型。 [0058] The present invention also relates to a specific site has a contour lines or grid patterns depicting appearance model body. 由于外观模型上描绘有等高线或网格图案，所以可客观地确定特定部位的变形。 Since drawing contour lines or grid patterns have the appearance model, it is possible to objectively determine the specific portion of the deformation. 尤其是在比较手术前后的外观模型后，可客观地确定手术进行了何种程度的变化。 Especially after the appearance of the model compare before and after surgery, surgery can objectively determine what degree of change.

[0059] 上述外观模型的优选实施方式为，所述外观模型是再现了患者特定部位表面的外观模型。 [0059] preferred embodiment of the above-described appearance model, the appearance model is a reproduction of the appearance of the patient specific model of the parts of the surface. 患者特定部位可包括前述的部位等，具体而言，如面部、头、四肢、胸、下腹部或腰寸。 Specific parts of the patient may include the aforementioned parts, etc., specifically, such as the face, head, limbs, chest, abdomen, or lower back inches.

[0060] 对于上述述任意一种外观模型，其优选包括如下工序。 [0060] For any of the above described appearance model, which preferably includes the following steps. 即，剖面数字信息获得工序：对患者的特定部位拍照，获得所述特定部位的剖视图的数字信息，该信息中具有所述患者特定部位的多个骨及软组织的剖视图；描绘信息获得工序：根据所述剖视图信息获得工序中获得的具有多个骨及软组织的剖视图的数字信息，计算所述特定部位的表面各部位距基准面的高度，或所述特定部位的表面各部位和基准点在平面上的错位量；外观模型制造工序：通过快速原型法制造所述患者特定部位的外观模型，并根据所述描绘信息获得工序中获得的高度或平面上的错位量，描绘等高线或网格图案。 I.e., cross-sectional view digital information obtaining step of: photographing a specific part of the patient, the digital information to obtain a cross-sectional view of the specific portion of the bone cross-sectional view of a plurality of specific parts of the patient and soft tissue with the information; drawing information obtaining step: According to The cross-sectional view digital information obtaining information sectional view of pluralities of bones and soft tissues obtained in the step of having to calculate the specific portion of the surface of each portion of the height from the reference plane, or a specific part of the surface of each portion and the reference point in the plane on the displacement amount; appearance model producing step: the rapid prototype method by producing patient specific parts appearance model, and based on the drawing information obtaining height or plane displacement amount obtained in the step of drawing contour lines or grid pattern. 通过这种制造方法，可恰当地制造外观模型。 In this manufacturing method, an appearance model can be properly produced. 此外，由于既可获得手术前的外观模型，又可获得手术后的外观模型，所以可显示出外科手术等手术前后外观发生了何种程度的变化。 Further, since the appearance model obtained either before surgery, and post-operative appearance model obtained, it is possible to show the extent of change in appearance before and after surgery, such as surgery happened.

[0061] 本发明还涉及一种赝复体的制造方法，该方法包括如下工序。 [0061] The present invention also relates to a method for producing a complex body of a pseudo, the method comprising the steps of. 即，剖视图数字信息获得工序：对患者的特定部位拍照，获得所述特定部位的剖视图的数字信息，该信息中包括所述患者特定部位的多个骨和软组织的剖视图；三维数字图像获得工序：根据在所述剖视图数字信息获得工序中获得的具有多个骨和软组织的剖视图的数字信息，获得所述特定部位的三维数字图像；赝复体图像数据获得工序：根据在所述三维数字图像获得工序中获得的所述特定部位的三维数字图像，获得赝复体图像数据；赝复体制造工序：根据所述赝复体图像数据获得工序中获得赝复体图像数据，通过快速原型法来制造赝复体。 I.e., cross-sectional view digital information obtaining step: the digital information cross-sectional view of a particular portion of the patient's photographs, obtaining the specific part of the information included in the sectional view of pluralities of bones and soft tissues of the patient-specific portion; three-dimensional digital image obtaining step of: According to a cross-sectional view of the digital information with a plurality of bone and soft tissue in the cross-sectional view digital information obtaining step, there was obtained the specific part of the three-dimensional digital image; prosthesis image data obtaining step: According to the three-dimensional digital images obtained three-dimensional digital image of the specific portion of the process, there was obtained image data prosthesis; prosthesis manufacturing process: the prosthesis according to the image data obtained in step prostheses image data obtained by the rapid prototype method prosthesis.

[0062] 本发明还涉及一种赝复体制造用铸模的制造方法，该方法包括如下工序。 [0062] The present invention also relates to a prosthesis fabrication method for producing a mold, the method comprising the steps of. S卩，剖视图数字信息获得工序：对患者的特定部位拍照，获得所述特定部位的剖视图的数字信息， 该信息中包括所述患者特定部位的多个骨和软组织的剖视图；三维数字图像获得工序：根据在所述剖视图数字信息获得工序中获得的具有多个骨和软组织的剖视图的数字信息，获得所述特定部位的三维数字图像；外观模型制造工序：根据在所述三维数字图像获得工序中获得的所述特定部位的三维数字图像，制造所述特定部位的外观模型；造型材料设置工序：对所述外观模型制造工序中获得的外观模型设置造型材料；造型材料数字信息获得工序：对在所述造型材料设置工序中设置有造型材料的外观模型拍照，获得造型材料的数字信息；铸模信息获得工序：根据在所述造型材料数字信息获得工序中获得的造型材料的数字信息，获得用于制造赝复体的铸模的数字数据；铸模制造工序：根据所述铸模信息获得工序中获得的信息制造铸模。 S Jie, cross-sectional view digital information obtaining step: a specific part of the patient's photographs, to obtain the digital information cross-sectional view of the specific portion of the information included in the sectional view of the plurality of bone patient specific part and soft tissue; three-dimensional digital image obtaining step : according to a cross-sectional view of a plurality of digital information of bones and soft tissue in the cross-sectional view having digital information obtaining step of obtaining, the specific site to obtain a three-dimensional digital image; appearance model producing step: based on the three-dimensional digital image obtained in step three-dimensional digital image of the specific portion of the gain, manufacturing the specific part of the appearance of the model; modeling material is disposed step: the appearance of the model set up the appearance model modeling material obtained in the manufacturing process; molding material digital information obtaining step: pair wherein the step of forming material disposed camera provided with an appearance model molding material, the molding material to obtain the digital information; mold information obtaining step: The digital information obtained in the forming material digital information obtaining step of molding material used to obtain manufacturing mold prosthesis digital data; mold manufacturing process: manufacturing the mold according to information obtained information obtaining step mold. 本发明中，例如，在左右对称部位的一部分缺损等情况下，根据剩下的部位来推定缺损部位的形状，由此可知，本发明可提供一种对称性好的赝复体制造方法或赝复体用铸模的制造方法。 The present invention, for example, in the part of the symmetrical parts of the defects, etc., according to the rest of the site is estimated defect of shape, can be seen, the present invention can provide a good symmetry prosthesis manufacturing method or pseudo duplexes mold manufacturing method used. 此外，本发明是通过CT扫描等获得特定部位的形状信息，再根据该形状信息用计算机来设计赝复体，从而患者不需要直接与印模材料等接触，由此可知，本发明可提供一种微创的赝复体制造方法或赝复体制造用铸模的制造方法。 Further, the present invention is obtained by a specific part shape information CT scan, and then based on the shape information using a computer to design prosthesis, so that the patient does not require direct contact with the impression material, etc., can be seen, the present invention can provide a Species minimally invasive method for producing a prosthesis or prosthesis fabrication method for producing a mold.

[0063]【发明效果】 [0063] Effect of the Invention

[0064] 本发明是在骨模型上描绘等高线或网格图案，所以可提供一种能确定患者等的骨变形的骨模型。 [0064] The present invention depicting contour lines or grid patterns on the bone model, it is possible to provide a bone model of a patient can be determined and other bone deformation.

[0065] 本发明是利用患者的骨模型设计骨填充材，所以可提供一种能制造高精确度骨填充材的骨填充材制造方法，所述骨填充材用于填充骨缺损部分。 [0065] The present invention is the use of the patient's bone model design bone filling material, it is possible to provide a method for producing a bone filler producing highly accurate bone filler, the bone filler material used to fill the bone defect portion. 尤其是在患者的骨模型上描绘有等高线或网格图案的情况下，可准确地确定患者的骨缺损部分或变形，从而可制造用于填充骨缺损部分的高精确度骨填充材。 In particular, has contour lines or grid pattern on the bone model of the patient's lower, can accurately determine the patient's bone defects or deformation, thereby manufacturing a highly accurate bone filler filling bone defect portion.

[0066] 本发明是利用患者的骨模型设计骨填充材，所以可提供一种能有效地修复骨变形(对称性较差等）的骨填充材制造方法。 [0066] The present invention is the use of the patient's bone model design bone filling material, it is possible to provide a bone repair efficiently deformed (poor symmetry, etc.) of the method of manufacturing a bone filler. 尤其是在患者的骨模型上描绘有等高线或网格图案的情况下，可准确地确定患者的骨变形，从而可制造用于填充骨缺损部分的高精确度骨填充材。 In particular, has contour lines or grid pattern on the bone model of the patient's lower, can accurately determine the patient's bone deformation, which can be manufactured for high-precision bone filler filling bone defect portion.

[0067] 本发明可提供一种既能防止骨填充材受外部撞击又能体现骨填充材形状的形状适当的石膏托制造方法。 [0067] The present invention can provide a bone filler by both preventing external shock but also reflects the shape of a bone filler shape appropriate plaster manufacturing method.

[0068] 本发明可提供一种外观模型，该外观模型能客观地表示骨变形症等患者其特定部位的外观出现了何种程度的变形。 [0068] The present invention provides an appearance model, the appearance model can objectively represent a deformed bone disorders in patients with a specific part of their physical appearance to what extent the deformation. 本发明还提供一种外观模型及其制造方法，其能在外科等手术中表现出外观在手术前后出现了何种程度的变化。 The present invention also provides a method of manufacturing the appearance of the model, which can show in surgery and other surgery in physical appearance to what extent changes before and after surgery.

[0069] 本发明中，例如在左右对称部位的一部分缺损等情况下，可根据剩下的部位来推定缺损部位的形状，因此本发明可提供一种对称性好的赝复体制造方法或赝复体用铸模的制造方法。 [0069] The present invention, for example in the part of the symmetrical parts of the defects, etc., can be estimated based on the remaining parts of the shape of the defect, and therefore the present invention can provide a good symmetry prosthesis manufacturing method or pseudo duplexes mold manufacturing method used. 此外，本发明是通过CT扫描等获得特定部位的形状信息，再根据该形状信息用 Further, the present invention is obtained by a specific part shape information CT scan, and then based on the shape information with

11计算机来设计赝复体，从而患者不需要直接与印模材料等接触，因此本发明可提供一种微创的赝复体制造方法或赝复体制造用铸模的制造方法。 11 computers to design prostheses, so the patient does not require direct contact with the impression material, the present invention provides a minimally invasive method for producing a prosthesis or prosthesis fabrication method for producing a mold.

附图说明 Brief Description

[0070] 图1是例示本发明骨填充材制造方法的基本工序的流程图。 [0070] FIG. 1 is a flowchart illustrating the basic steps of the method of producing a bone filler of the present invention.

[0071] 图2是本实施例中各步骤的示意图。 [0071] FIG. 2 is a diagram illustrating the various steps of the implementation.

[0072] 图3是通过CT拍摄到的CT图像，以此替代附图。 [0072] FIG. 3 is photographed by CT CT images, in place of the accompanying drawings. 图3(a)是脸颊部分的CT图像， 图3(b)是下颚部分的CT图像。 Figure 3 (a) is part of the cheek CT image, Figure 3 (b) is a CT image jaw portion.

[0073] 图4是实施例中获得的骨模型的照片和立体图，以此替代附图。 [0073] FIG. 4 is a perspective view of a photograph and a bone model obtained in example, as an alternative to the accompanying drawings. 图4(a)表示获得的石膏模型（骨模型），图4(b)表示骨模型的侧视图，图4(c)表示描绘有等高线的骨模型的设计图。 Figure 4 (a) shows the gypsum model (a bone model) obtained by Fig 4 (b) shows a side view of a bone model, Figure 4 (c) shows the bone model depicts the contour lines of the design.

[0074] 图5是设置有造型材料的骨模型的照片，以此替代附图。 [0074] FIG. 5 is provided with a photograph of the bone model forming material, as an alternative to the accompanying drawings. 图5 (a)是主视图，图5 (b) 是侧视图，图5(c)是仰视图。 Figure 5 (a) is a front view, FIG. 5 (b) is a side view, FIG. 5 (c) is a bottom view.

[0075] 图6是设置有造型材料的骨模型的CT图像，以此替代附图。 [0075] FIG. 6 is provided with a bone model of the CT image forming material, as an alternative to the accompanying drawings. 图6(a)是脸颊部分的CT图像，图6(b)是下颚部分的CT图像。 Figure 6 (a) is part of the cheek CT image, Figure 6 (b) is a CT image jaw portion.

[0076] 图7是本实施例中获得的骨填充材的照片，以此替代附图。 [0076] FIG. 7 is obtained in the bone filler photos to this embodiment, as an alternative to the accompanying drawings. 图7(a)是植入脸颊部分的骨填充材的图，图7(b)是表示图7(a)中所述骨填充材的内表面的图。 Figure 7 (a) is implanted in the cheek bone filler portion, and FIG. 7 (b) shows 7 (a) in the inner surface of the bone filling material of FIG. 图7(c)是表示植入下颚部分的骨填充材的图，图7(d)是表示图7(c)中所述骨填充材的内表面的图。 Figure 7 (c) shows a portion of the lower jaw bone implant filler, and FIG. 7 (d) is a diagram showing an inner surface 7 (c) in the bone filler of FIG.

[0077] 图8是描绘有等高线的石膏像（外观模型）的照片，以此替代附图，该等高线表示患者面部的高低起伏，该患者是用实施例中获得的骨填充材来实施手术的患者。 [0077] FIG. 8 is a contour line is drawn in the plaster (appearance models) pictures, as an alternative to the drawings, the undulating contour line represents the face of the patient, the patient is a bone filler obtained in Example to implement patient surgery. 图8(a)是手术前的图，图8(b)是手术后的图。 Figure 8 (a) is before the surgery, and Fig. 8 (b) is a view after surgery.

[0078]〔附图标记说明〕 [0078] [Description of Symbols]

[0079] 1 ：骨模型、2 ：骨缺损部分、3 ：造型材料、4 ：骨填充材。 [0079] 1: a bone model, 2: bone defect site, 3: modeling materials, 4: bone filler. 具体实施方式 DETAILED DESCRIPTION

[0080] 1.骨填充材的制造方法 [0080] A method for producing a bone filler

[0081] 本发明涉及一种骨填充材的制造方法，该方法包括如下工序。 [0081] The present invention relates to a method for producing a bone filler, the method comprising the following steps. 骨数字信息获得工序：对患者的特定部位拍照，获得所述患者特定部位的骨的数字信息，该信息中包括多个骨的剖视图；骨模型制造工序：根据在所述骨数字信息获得工序中获得的包括多个骨的剖视图的数字信息，制造所述患者特定部位的骨模型；造型材料设置（填充）工序：对在所述骨模型制造工序中制造的骨模型设置造型材料；造型材料数字信息获得工序：对在所述造型材料设置工序中设置有造型材料的骨模型拍照，获得造型材料的数字信息；骨填充材制造工序：根据在所述造型材料数字信息获得工序中获得的造型材料的数字信息，制造骨填充材。 Bone digital information obtaining step of: photographing a specific part of the patient, the patient-specific portion of the obtained bone digital information, a sectional view of a plurality of information includes the bone; bone model producing step: based on the bone digital information obtaining step obtaining the digital information comprises a plurality of cross-sectional view of the bone, producing patient specific part of the bone model; molding material is disposed (filled) Step: bone model produced in the bone model producing step is provided forming material; forming material digital Information obtaining step: to set the molding material is provided in the step of molding material bone model camera, access to digital information modeling materials; bone filler producing step: According to the shape of the material obtained in the molding material digital information obtaining step The digital information to produce a bone filler. 即，对于模型形成工序以及像成形后制造骨填充材的工序等优选以数字式进行的工序，是根据数字信息而进行的。 That is, the process is preferably carried out in the digital model image forming step and a step for producing a bone filling material after molding or the like, it is carried out according to digital information. 此外，如后所述，本发明是在设计一种易于反映外科医生专业技术的环境后，如在骨模型上描绘等高线，由外科医生在骨模型上设置造型材料，模拟性地反映出外科医生的专业技术，这样，可制造出精确度较高的骨填充材。 In addition, as described later, the present invention is reflected in the design of an easy-surgeon specializing in technology environments, such as contour lines are drawn on the bone model, set up by the surgeon-forming material on the bone model, simulate sex reflects surgeon's expertise, so that can produce high precision bone filler.

[0082] 对于上述骨填充材的制造方法，其优选实施方式为，对所述患者的特定部位进行拍照的工序是通过CT扫描或MRI获得所述患者特定部位的骨的数字信息的工序，该信息中包括多个骨的剖视图；所述造型材料数字信息获得工序是通过CT扫描或MRI获得造型材料的数字信息的工序。 [0082] For the above-described method for producing a bone filler, a preferred embodiment thereof, a specific portion of the step of photographing a patient is obtained by a CT scan or MRI of the process of bone digital information specific part of the patient, the sectional view of a plurality of information should be included bone; the molding material digital information obtaining step is a step of obtaining digital information modeling material by CT scan or MRI. 即，通过CT扫描或MRI，能比较容易地获得多个包括骨或造型材料的造型的剖视图。 That is, by CT scan or MRI, can more easily include a plurality of cross-sectional view of the bone or the shape of molding material gain. 通过该CT图像或MRI图像，能用计算机等容易地获得骨或造型材料的三维数字信息。 CT or MRI image by the image, use computers and other easily obtained bone or three-dimensional digital modeling material information. 对于上述任意一种骨填充材的制造方法，其优选实施方式为，所述患者特定部位是指患者的颅骨、下颚部分、上颚部分、四肢、骨盆中之一的部位。 For any of the above-described method for producing a bone filler, a preferred embodiment thereof, refers to the portion of the patient specific patient skull, jaw portion parts, upper jaw, four limbs, one of the pelvis. 这些部位均为左右对称的结构，所以能够容易地确定出骨变形情况。 These parts are symmetrical configuration, it is possible to easily determine bone deformation. 用于CT扫描或MRI的CT摄影装置可采用公知的影像装置。 CT photographing apparatus for a CT scan or MRI images may be a known means. CT摄影装置优选与计算机相连接。 CT imaging means is preferably connected to the computer. 计算机优选具有：用于与CT装置或监视器相连的输入输出装置；用于存储CT或MRI图像数据的存储部；进行各种运算的控制部（运算部）；内部存储有如下程序的主存储器，即，根据多个CT图像数据或MRI图像数据获得所拍部位（对象部位）的三维数字数据的程序；以及连接各装置的总线。 Computer preferably comprises: means for inputting an output connected to a monitor or the CT apparatus; storage unit for storing a CT or MRI image data; controlling various operations of the unit (calculating unit); internal main memory stores the following programs , i.e., the program according to the plurality of CT image data or MRI image data obtained by the shot site (target site) in a three-dimensional digital data; and means connecting each of the bus.

[0083] 对于上述任意一种骨填充材的制造方法，其优选实施方式为，在所述骨模型制造工序中制造的骨模型是描绘有等高线或网格图案的骨模型。 [0083] For any of the above-described method of manufacturing a bone filler, a preferred embodiment thereof, the bone model produced in the bone model producing step has contour lines or grid patterns bone model. 通过在骨模型上描绘等高线或网格图案，在设置造型材料时，外科医生可根据获得的骨模型极其容易地确定骨的变形或凹陷等情况，因此，可获得高精确度的骨填充材。 By depicting contour lines or grid pattern on the bone model when setting molding material, the surgeon can determine very easily deformed or depressed bone, etc. The bone model obtained, therefore, obtain highly accurate bone filler material.

[0084] 对于上述任意一种骨填充材的制造方法，其优选实施方式为，在所述骨模型制造工序所制造的骨模型是含有石膏的骨模型。 [0084] For any of the above-described method of manufacturing a bone filler, a preferred embodiment thereof, the model of the bone in the bone model producing step is produced in the bone model containing gypsum. 对于上述任意一种骨填充材的制造方法，其优选实施方式为，所述骨模型制造工序是通过快速原型法、注塑成型法、由切割产生的层压成型法或采用具有加工中心的加工装置的成型法来制造骨模型的工序。 For any of the above-described method for producing a bone filler, a preferred embodiment thereof, the bone model producing step by the rapid prototype method, injection molding method, a lamination molding method produced by the cutting or machining using a machining center having means The molding process of producing a bone model. 若骨模型以石膏作为主要成分，就能通过下述任意一种成型法容易地制造骨模型：快速原型法；注塑成型法，根据以CT扫描或MRI等方式拍摄的骨数字信息设计模具，并利用该模具来制造骨模型；根据获得的骨的数字信息，采用具有加工中心的加工装置的成型法；根据获得的骨的数字信息， 利用具有多轴钻床并可进行NC控制的切削装置的成型法。 If the bone model contains gypsum as a main component, it can be formed by any of the following methods for producing a bone model easily: the rapid prototype method; injection molding method, according to figures bone CT scan or MRI, etc. recorded information design mold, and using the mold for producing a bone model; based on the obtained bone digital information, using the molding method having a machining center processing apparatus; based on the obtained bone digital information, with the use of multi-axis drilling and molding the NC-controlled cutting apparatus method. 对于由切割产生的层压成型法， 例如可按照日本发明专利公开公报特开平8490347号所公开的技术内容来实施。 For lamination method generated by the cutting, for example, in accordance with the technical content of Japanese Patent Application Laid-open No. 8,490,347 disclosed implemented. 该方法是：“一种层压成型法，是将三维形状分成多层并顺次层压形成的各层来制造三维形状物体的方法，其特征在于，按照由三维数值数据形成各层的三维加工程序，用切削工具或磨削工具等工具将板材加工成三维曲面状，然后，将未经加工的板材层压在加工后的板材上，并反复执行如下工序，即，通过所述工具将未经加工的板材加工成三维形状的工序，由此形成三维形状物体”。 The method is: "a laminate molding method, the three-dimensional shape is divided into multiple layers and the layers are sequentially laminated to a method of manufacturing a three-dimensional shape of the object is formed, characterized in that, in accordance with the three-dimensional three-dimensional numerical data forming the layers processing program, using a cutting tool or grinding tools and other tools into a three-dimensional curved sheet metal processing, and then the unprocessed sheet laminated on the plate after processing, and repeatedly perform the following steps, namely, by the tool unprocessed plate processing step of a three-dimensional shape, thereby forming a three-dimensional shape of the object. " 所述层压成型法也可以是日本发明专利公开公报特开平3-M4510号和特开平5-313584号公报所公开的层压成型法。 The lamination method may also be Japanese Patent Application Laid-open No. 3-M4510 and JP-A-5-313584 Gazette disclosed lamination method. 即，根据成型对象各层的二维形状数据将该成型对象切割片状材料，再顺次层压各片状材料，由此将三维形状物体层压成二维半形状。 That is, the two-dimensional shape of the object data forming the layers forming the object cutting sheet materials, each sheet of material and then sequentially laminated, whereby the laminated three-dimensional shape of the object into a two-dimensional semi-shape. 所述层压成型法还可以是日本发明专利公开公报特开昭62-35966号和特开平4-103339号所公开的层压成型法。 The lamination method may also be Japanese Patent Application Laid-Open Patent Publication No. 62-35966 and JP-A No. 4-103339 disclosed lamination method. 即，先用光束照射液态光固化树脂，形成规定形状的固化层（工序1)；然后，供给未固化的液态光固化树脂到该固化层上，并用光束照射使之形成新的固化层（工序幻；接下来反复执行工序2，层压新的固化层到原来的固化层上，由此将三维形状物体层压成二维半形状。所述加工中心可采用公知技术，如日本发明专利公开公报特开2004-074376号、特开2003-94264号或特开2001-150262号所公开的技术。所述多轴钻床(如五轴钻床）可采用日本发明专利公开公报特开2006-5257号、特开2001-230223号或特开2000-176715号所公开的技术。 That is, the first light beam irradiated liquid photocurable resin to form a predetermined shape of the cured layer (step 1); then, supplying an uncured liquid photocurable resin onto the cured layer and irradiating a light beam so as to form a new cured layer (step phantom; Next Step 2 is repeated, the new cured layer laminated on the cured layer of the original, thereby laminating the three-dimensional shape of the object into a two-dimensional shape of a half of the machining center using well known techniques, as described in Japanese Patent Publication. Laid-open No. 2004-074376, JP 2003-94264 or Laid-open No. 2001-150262 disclosed technology. The multi-axis drilling (such as five-axis drilling) may be Japanese Patent Laid-open No. 2006-5257 , as disclosed in JP-A-2001-230223 or JP 2000-176715 technology.

[0085] 对于上述任意一种骨填充材的制造方法，其优选实施方式为，在所述骨模型制造工序中制造的骨模型是如下一种骨模型：含有钙类物质和聚乙烯醇树脂，当所述钙类物质和所述聚乙烯醇树脂的总重量为100重量份时，所述聚乙烯醇树脂的重量份为2重量份〜8 重量份。 [0085] For any of the above-described method for producing a bone filler, a preferred embodiment thereof, the bone model produced in the bone model producing step is a bone model as follows: calcium-based material and polyvinyl alcohol resin containing, When the total weight of the calcium-based material and the polyvinyl alcohol resin is 100 parts by weight, the parts by weight of the polyvinyl alcohol resin is 2 parts by weight of ~ 8 parts by weight. 采用这种骨模型，可按照所述各种成型法尤其是注塑成型法，极其迅速地获得高精确度的骨模型，所以能制造出高精确度的骨填充材。 With this bone model, in accordance with the various molding methods, especially injection molding, extremely rapid access to highly accurate bone model, it is possible to produce high precision bone filler. 对于上述任意一种骨填充材的制造方法，其优选实施方式为，在所述骨模型制造工序中制造的骨模型是如下一种骨模型：以含有α型半水石膏和聚乙烯醇树脂的组合物为原料，当所述钙类物质和所述聚乙烯醇树脂的总重量为100重量份时，所述聚乙烯醇树脂的重量份为2重量份〜8重量份。 For any of the above method for producing a bone filling material, which is a preferred embodiment of the bone model produced in the bone model producing step is a bone model as follows: containing α-hemihydrate gypsum and polyvinyl alcohol resin The composition of the raw material, when the total weight of the calcium-based material and the polyvinyl alcohol resin is 100 parts by weight, the parts by weight of the polyvinyl alcohol resin is 2 parts by weight of ~ 8 parts by weight.

[0086] 对于上述任意一种骨填充材的制造方法，其优选实施方式为，所述骨模型以石膏为主要成分，所述造型材料含有总重量的90重量％以上的蜡或塑料。 [0086] For any of the above-described method of manufacturing a bone filler, a preferred embodiment thereof, the bone model contains gypsum as the main ingredient, the total weight of the molding material contains 90 wt% or more of a wax or plastic. 对于上述任意一种骨填充材的制造方法，其优选实施方式为，所述骨模型以石膏为主要成分，所述造型材料含有总重量的90重量％以上的蜡。 For any of the above-described method for producing a bone filler, a preferred embodiment thereof, the bone model contains gypsum as the main ingredient, the total weight of the molding material contains 90 wt% or more of wax. 对于上述任意一种骨填充材的制造方法，其优选实施方式为，所述骨模型以石膏为主要成分，所述造型材料含有总重量的90重量％以上的蜡，还含有总重量的2重量％以上且5重量％以下的金红石型氧化钛。 For any of the above-described method for producing a bone filler, a preferred embodiment thereof, the bone model contains gypsum as the main ingredient, the total weight of the molding material contains 90 wt% or more of a wax, further comprising by weight of the total weight of 2 % or more and 5% by weight of rutile titanium oxide. 即，通过采用这种组成的骨模型和造型材料，在以CT扫描或MRI等方式拍摄时，可精确地分析出骨模型部分和造型材料部分，所以能制造高精确度的骨填充材。 That is, by using the bone model and modeling material of this composition, in the order a CT scan or MRI, etc. shooting, you can accurately analyze the bone part of the model and modeling material portion, it is possible to manufacture a highly accurate bone filler.

[0087] 对于上述任意一种骨填充材的制造方法，其优选实施方式为，所述骨填充材制造工序是通过快速原型法制造骨填充材的工序。 [0087] For any of the above-described method of manufacturing a bone filler, a preferred embodiment thereof, the bone filler producing step is a step by the rapid prototype method step for producing a bone filling material. 通过采用快速原型法，可快速、精确地制造定制的骨填充材。 By using rapid prototyping, you can quickly and accurately manufacture custom bone filler.

[0088] 对于上述任意一种骨填充材的制造方法，其优选实施方式为，在所述骨填充材制造工序中获得的骨填充材是由如下物质中任意一种或任意两种以上制成，即，羟基磷灰石、 碳酸磷灰石、氟磷灰石、氯磷灰石、β-TCP、α-TCP、偏磷酸钙、磷酸四钙、磷酸八钙、磷酸氢钙、磷酸二氢钙、焦磷酸钙、它们的盐或溶剂化物。 [0088] For any of the above-described method of manufacturing a bone filler, a preferred embodiment thereof, a bone filler obtained in the bone filler producing step is any one or any of the following materials is made of two or more , i.e., hydroxyapatite, carbonate apatite, fluorapatite, chlorapatite, β-TCP, α-TCP, calcium metaphosphate, tetracalcium phosphate, octacalcium phosphate, hydrogen phosphate, dihydrogen phosphate calcium pyrophosphate, salts thereof or solvates. 若按照如注塑成型法用上述原料制造骨填充材，则会在成型时出现相变，变成特性更好的骨填充材。 If such an injection molding method in accordance with the raw material for producing a bone filler, is a phase change occurs at the time of molding, the characteristics become better bone filler.

[0089] 2.骨模型 [0089] 2. bone model

[0090] 本发明还涉及一种描绘有等高线或网格图案的骨模型。 [0090] The present invention further relates to a kind of contour lines or grid patterns depicted bone model. 由于骨模型上描绘有等高线或网格图形（格状线），所以能容易地确定骨模型的变形情况。 Since there is depicted contour lines or grid patterns (trellis) on the bone model, it is possible to easily determine the deformation of a bone model. 等高线可以以骨模型上的某一点为高度计算基准点（高度最低的点），例如以0. Imm〜Icm的高度间隔来设置，优选以0. 5mm〜5mm的高度间隔来设置，更优选以0. 5mm〜2mm的高度间隔来设置。 Contour can calculate the height of a point to the reference point (the height of the lowest point) of the bone on the model, for example, 0. Imm~Icm height interval to set, preferably in height to set the interval 0. 5mm~5mm more preferably 0. 5mm~2mm height interval to set. 例如，当骨模型是颅骨的模型时，可以以后头部作为基准点来描绘等高线。 For example, when the skull bone model is a model, it can later head as a reference point to describe the contour. 等高线可以描绘在整个骨模型上，也可以只描绘在骨模型的一部分上。 Contour lines can be drawn on the entire bone model to be drawn on only a portion of the bone model. 颅骨的模型可以是整个颅骨的模型，也可以是颅骨上所需部分的模型。 The model can be an entire skull skull model can also be a desired portion of the skull model. 该所需部分可以是颅骨的前半部分（面部）。 The required portion may be the first part of the skull (face). 为了制造用于口腔内部的骨填充材，该所需部分可以是仅仅下颚部分、仅仅上颚部分或下颚部分和上颚部分等。 In order to produce a bone filler used inside the mouth, the lower jaw portion may be only part of the desired, only the upper jaw or lower jaw portion and the upper jaw portion and other portions. 描绘在骨模型上的网格图形不限于格子状，可在骨模型上只描绘网格点。 Drawn on the bone model is not limited to a lattice-like grid pattern can only describe the bone model grid points. 网格图形可以按0. Imm〜3cm的间隔来设置，优选按0. 5mm〜Icm的间隔来设置，更优选按Imm〜5mm 的间隔来设置。 0. Imm~3cm grid pattern can be arranged at intervals, preferably by 0. 5mm~Icm set intervals, preferably by Imm~5mm set intervals. 网格图形可描绘在整个骨模型上，也可只描绘在骨模型的一部分上。 Grid pattern can be drawn on the entire bone model can also be drawn on only a portion of the bone model. 这种骨模型可采用公知方法等来制造，如后述的快速原型法。 This bone model can be used to manufacture a known method, such as rapid prototyping later. 具体而言，例如按照快速原型法制造骨模型时，是根据多张数字图像获得骨模型的三维信息，然后根据该三维信息获得与骨模型的表面部位相关的高度信息，再根据所获得的高度信息，获得关于等高线描绘位置的描绘信息，接下来，将墨等喷在计算机所设定的位置，在按照如上述的快速原型法来制造 Specifically, for example according to the rapid prototype method when producing a bone model, the bone model is to obtain three-dimensional information in accordance with a plurality of digital images, and to obtain information about the height of the surface portion of the bone model based on the three-dimensional information associated with, according to the obtained height information, obtain information about the contours depict drawing position, then, ink jet and other computers in the set position, as described above in accordance with the rapid prototype method

14骨模型时，可根据所述获得的描绘信息来描绘等高线。 14 bone model, contour lines can be depicted according to the drawing information obtained. 此外，在描绘网格图形时，例如，在按照快速原型法制造骨模型时，是根据多张数字图像来获得骨模型的三维信息，然后根据该三维信息获得与骨模型的表面部位相关的二维位置信息，再根据所获得的二维位置信息， 获得关于网格图形描绘位置的描绘信息，接下来，将墨等喷在计算机所设定的位置，在按照如上述的快速原型法来制造骨模型时，可根据所述获得的描绘信息来描绘网格图形。 In addition, when drawing a grid pattern, e.g., in the manufacture of a bone model, based on a plurality of digital images to obtain three-dimensional information of a bone model by the rapid prototype method, then based on the obtained three-dimensional information of the surface portion of the bone model associated two dimensional position information, according to the two-dimensional position information obtained, to obtain a grid pattern on the drawing depicting the location information, the next will be in a position such as ink jet computer set, as described above in accordance with the rapid prototype method When bone model, can be based on a grid pattern depicting the obtained drawing information.

[0091] 对于上述骨模型，其优选实施方式为，所述骨模型是再现有患者特定部位的骨形状的模型。 [0091] For the above-described bone model which is a preferred embodiment, the bone model is a reproduction of a bone shape of a patient specific model of the site. 对于上述骨模型，其另一优选实施方式为，所述骨模型是再现有患者颅骨的骨形状的模型。 For the above-described bone model which is a further preferred embodiment, the bone model is a reproduction of a bone shape of a patient's skull model. 即，当骨模型是患者定制的骨模型时，可准确地确定该患者的骨凹陷情况。 That is, when the bone model is customized patient bone model, you can accurately determine the patient's bone depressed situation. 因此， 这种骨模型对于恰当地确定骨填充材的形状也是非常有效的，从而能获得形状更合适的骨填充材。 Therefore, this model for bone appropriately determined shape bone filler is very effective, so that it can obtain a more suitable shape bone filler. 骨模型的材质可以是后述的石膏、热固化树脂、热可塑性树脂、光固化树脂。 The material may be a bone model of gypsum will be described later, a thermosetting resin, a thermoplastic resin, photocurable resin.

[0092] 3.骨填充材的制造方法 [0092] The method for producing a bone filler

[0093] 下面，根据附图说明骨填充材的制造方法。 [0093] Next, a manufacturing method according to the drawings bone filler. 图1例示了本发明骨填充材制造方法的基本工序的流程图。 Figure 1 illustrates the basic steps of the method of producing a bone filler of the present invention, a flow chart. 该图中的“S”表示“步骤”。 The figure "S" means "step." 如图1所示，本发明的骨填充材的制造方法大致包括如下工序。 As shown in Figure 1, the method for producing a bone filler of the present invention generally comprises the following steps. 骨模型制造工序（步骤1)：制造骨模型（1)；造型材料填充工序(步骤幻：将造型材料C3)填充在所述骨模型制造工序中获得的骨模型（1)的骨缺损部分(2)上；骨填充材制造工序（步骤幻：根据所述造型材料填充工序中填充在骨模型的骨缺损部分上的造型材料，制造用于填充骨缺损部分的骨填充材。通过填充该骨填充材在骨缺损部分而进行治疗等，可修复缺损部分，治疗骨缺损问题。图1中，附图标记“5”表示修复后的骨。此外，为了说明各工序中骨缺陷模型等的状态，还在图1中各工序的右边增加了示意图。 The bone model producing step (step 1): producing a bone model (1); forming material filling step (Step Magic: The molding material C3) a bone model (1) is filled in the bone model producing step is a bone defect portion obtained ( 2); bone filler producing step (step Magic: According to the molding material-forming material filling step of filling the bone defect site of the bone model, bone filler producing for filling bone defects by filling the bone portion. filler in bone defect portion for treatment, etc., to repair the defect part, treatment of bone defects problems. Figure 1, reference numeral "5" after the repair of bone. In addition, in order to show the status of each step of the bone defect models , also the right in Figure 1 a schematic diagram of each step increases.

[0094] 3-1.骨模型制造工序（步骤1) [0094] 3-1. Bone model producing step (step 1)

[0095] 骨模型制造工序是用于制造骨模型的工序。 [0095] bone model producing step is a step for producing a bone model. 总体而言，对骨模型的制造方法并无特别限定，只要可制造患者的骨模型即可，可选择采用公知方法来制造骨模型。 In general, the method for producing a bone model is not particularly limited, as long as the bone model can be produced to a patient, optionally using a known method for producing a bone model. 骨模型的制造方法包括如下两种方法，即，先通过骨的X射线等图像制造模具，再将模型原料灌注在该模具中，由此制造骨模型的方法；以及采用快速原型法制造骨模型的方法。 The method of producing a bone model include the following two methods, i.e., the first X-rays by bone image production tool, then perfusion model in the mold material, whereby the method for manufacturing the bone model; and the use of rapid prototyping method for producing a bone model approach. 其中，优选采用快速原型法制造骨模型，因为骨模型是根据数字数据来制造。 Among them, the use of rapid prototyping method for producing a bone model, because the bone model is manufactured according to the digital data.

[0096] 近年来，用于简易制造三维结构的快速原型装置（如，特表2001-524897号公报、 特表2003-531220号公报、特表2004-538191号公报、特表2005-503939号公报、美国专利5204055号说明书、美国专利5340656号说明书、美国专利5387380号说明书、美国专利6007318号说明书、美国专利6375874号说明书、美国专利590M41号说明书以及6416850 号说明书，以此引入本说明书作为参考）和快速原型法迅速得到普及。 [0096] In recent years, rapid prototyping apparatus for manufacturing three-dimensional structures of simple (eg, JP No. 2001-524897, JP No. 2003-531220, JP No. 2004-538191, JP Publication No. 2005-503939 US Patent No. 5,204,055 specification, US Patent No. 5,340,656 specification, US Patent No. 5,387,380 specification, US Patent No. 6,007,318 specification, US Patent No. 6,375,874 specification, US Patent No. 6,416,850 and No. 590M41 manual instructions, as incorporated herein by reference) and Rapid prototyping rapidly gaining popularity. 装置的原型零件（试制品）等立体造型的三维物体用于检查它们的性能。 Device prototype parts (prototype) and other three-dimensional modeling of three-dimensional objects to check their performance. 已公知的快速原型法有，根据剖面形状数据形成薄层，然后层压该薄层来形成三维形状的方法，包括光造型法、粉末烧结法、粉末粘合法和固态基础熟化法等。 Has known rapid prototyping have formed a thin layer of a cross-sectional shape of the data, and then laminating the thin layer method of forming a three-dimensional shapes, including optical modeling method, a powder sintering method, powder bonding and solid basis for curing method. 光造型法是指，按照计算机中存储的照射图案，将激光照射在若照射规定的光则会固化的液态树脂材料（光固化树脂）上，这样，逐步再现造型对象的形状。 Optical modeling method is a method, in accordance with the irradiation pattern stored in the computer, the liquid resin material is irradiated with laser irradiation when prescribed light is cured (light-cured resin), and so, gradually reproduce the shape of the shape of the object. 即，本说明书中的骨模型等可通过光固化树脂等树脂形成。 That is, this specification bone models can be light-cured resin, the resin is formed. 对于光固化树脂和使光固化树脂固化的光源，可采用日本发明专利公开公报特开2004-49877号所记载的光固化树脂和光源等。 For light-cured resin and the light-curable resin curing light source, can be used in Japanese Patent Laid-open No. 2004-49877 described light curable resin and a light source. 粉末烧结法是指，将粉末材料铺成较薄的层状，按照计算机中所存储的描绘图案，喷出粘结剂，使所述粉末材料粘结在一起，并反复执行形成粉末材料层和喷出粘结剂的动作，这样，形成粉末材料结合体这样的三维造型物体。 Means a powder sintering method, the powder material thin layer paved, in accordance with the stored computer drawing pattern, ejection binder bonded together so that the powder material, and is repeatedly executed to form a powder material layer and spray adhesive action, so that a three-dimensional shape of an object such as a combination of powder materials. 即，本说明书中的骨模型等可通过热塑性树脂或热固性树脂等高分子（聚合物）形成。 That is, this specification bone models can be a thermoplastic or thermosetting resin and other polymer (polymer) form. 可通过用高温烧结形成的粉末粘合物来获得骨模型等。 By binding with high-temperature sintering the powder form to obtain the bone model. 此时，优选热固性树脂作为原料。 In this case, preferably a thermosetting resin as a raw material. 粉末可采用金属粉末，从而本说明书中的骨模型等可以是钛、铁、铝、铜、银、金、镍、铅、锡等中任何一种或任意两种以上的组合。 Powder metal powder can be used, so this specification bone models can be any one or any two of titanium, iron, aluminum, copper, silver, gold, nickel, lead, tin, etc. or in combination. 此外，因白金或钯等的合金受激光等照射时会硬化，所以可按照计算机中存储的照射图案， 将激光照射它们的金属粉末薄层上来逐步再现造型对象的形状。 In addition, due to alloy platinum or palladium will harden when irradiated by the laser, it is possible in accordance with the irradiation pattern stored in the computer, the laser irradiation onto a thin layer of a metal powder which progressively shape reproducing the shape of the object.

[0097] 本发明中，为了制造骨模型，优选采用对RP法作了适当修改的方法。 [0097] The present invention, in order to manufacture bone model, preferably made appropriate use of the RP method modifications. 具体而言， 在所述骨填充材的制造方法中，所述骨模型制造工序包括如下工序。 Specifically, in the manufacturing method of the bone filling material, the bone model producing step comprises the steps of. 剖面形状获得工序： 根据患者的骨的三维形状信息，获得所述三维形状在分成多层后得到的各层的剖面形状信息；第一剖面（断层）造型形成工序：根据在所述剖面形状获得工序中获得的所述剖面形状信息，读取第一层的剖面形状信息，再根据读取的信息，利用造型用组合物形成其上再现有所述剖面形状的第一剖面造型；第二剖面（断层）造型形成工序：根据在所述剖面形状获得工序中获得的所述剖面形状信息，读取位于第一剖面造型上层的第二层的剖面形状信息，再根据读取的信息，利用造型用组合物形成第二剖面造型，该第二剖面造型上再现有所述剖面形状，并重叠在所述第一剖面造型上；立体造型获得工序：其用于获得再现有物体形状的立体造型，该工序与所述第二剖面造型形成工序相同，反复执行如下工序，即，根据在所述剖面形状获得工序中获得的所述剖面形状信息，读取所述欲形成层的剖面形状信息，再根据读取的信息，利用造型用组合物形成所述层的剖面造型，该造型上再现有所述剖面形状，并重叠在前一工序中所获得的剖面造型上。 Cross-sectional shape obtaining step: three-dimensional shape information of the bone of the patient, the layers of the cross-sectional shape information to obtain the three-dimensional shape obtained after the divided multilayer; a first cross-sectional (tomographic) shape forming step: in accordance with the cross-sectional shape The cross-sectional shape information obtained in the step of reading a first cross-sectional shape of the information layer, then the information is read by a first cross-sectional shape which shape is formed on the reproduction of the cross-sectional shape has the composition; the second cross-sectional (CT) shape forming step: based on the information obtained in the cross-sectional shape of the cross-sectional shape obtaining step, the cross-sectional shape in the first reading the upper cross-sectional shape information of the second layer, and then based on the information read by the shape The composition for forming a second cross-sectional shape, the cross-sectional shape of the second Representing the cross-sectional shape, and superimposed on the first cross-sectional shape; three-dimensional modeling to get the steps of: reproducing an object for obtaining the shape of three-dimensional modeling, The step of forming the second cross-sectional shape of the same process, the following process is repeatedly performed, i.e., based on the cross-sectional shape of the cross-sectional shape information obtained in the obtaining step, want to read the cross-sectional shape of the information layer is formed, and then According to the information read using the composition for forming a cross-sectional shape of said molding layer, there is the cross-sectional shape reproducing the shape, and superimposed on a cross-sectional shape obtained in the previous step. 其中，所述剖面造型形成工序中至少一个以上的工序包括如下两工序。 Wherein the step of at least one or more two-step process comprising forming the cross-sectional shape. 造型用组合物层获得工序：使造型用组合物的粉末为层状，形成造型用组合物层；水分添加工序：根据该层的剖面形状信息，将水分添加在所述造型用组合物层获得工序中所形成的造型用组合物层上，这样，使所述造型用组合物层的规定位置润湿。 Figure-forming composition layer obtaining step: making molding powder composition is layered, forming figure-forming composition layer; water adding step: based on the cross-sectional shape of the information layer, the water added to the molding composition layer is obtained modeling process used in the formation of the composition layer, so that the shape of a predetermined position wetting composition layer.

[0098] 造型用组合物可采用公知的物质，但优选含有钙类物质和聚乙烯醇树脂的造型用组合物。 [0098] modeling using well-known material composition, but preferably contain modeling calcium-based material and polyvinyl alcohol resin compositions. 例如，在所述钙类物质和所述聚乙烯醇树脂的总重量为100重量份时，所述聚乙烯醇树脂的重量份为2重量份〜8重量份的造型用组合物。 For example, when the total weight of the calcium-based material and the polyvinyl alcohol resin is 100 parts by weight, the parts by weight of the polyvinyl alcohol resin is 2 parts by weight of ~ 8 parts by weight of the molding composition.

[0099] 造型用组合物优选含有钙类物质、聚乙烯醇树脂和固化促进剂的造型用组合物。 [0099] modeling contain calcium-based material composition preferably, polyvinyl alcohol resins and curing accelerator-forming composition. 所述固化促进剂为从二水石膏、碱金属硫酸盐、碱土类金属硫酸盐、碱金属氯化物盐、碱土类金属氯化物盐、无机酸的铵盐以及明矾类所构成的群组中选择出的一种或两种以上的固化促进剂。 The curing accelerator to be selected from the group dihydrate gypsum, alkali metal sulfates, alkaline earth metal sulfates, alkali metal chloride salt, alkaline earth metal chloride salt, inorganic acid ammonium alum and the class consisting of one or two or more of the curing accelerator. 在所述钙类物质和所述聚乙烯醇树脂的总重量为100重量份时，所述聚乙烯醇树脂为2重量份〜8重量份，所述固化促进剂为0. 1重量份〜5重量份。 In the calcium-based material and the total weight of the polyvinyl alcohol resin is 100 parts by weight when the polyvinyl alcohol resin is 2 parts by weight of ~ 8 parts by weight, the curing accelerator is 0.1 ~ 5 parts by weight parts by weight. 此外，该实施方式中的造型用组合物优选只由钙类物质、聚乙烯醇树脂以及固化促进剂组成。 Further, in this embodiment of the figure-forming composition preferably solely by calcium-based material, a polyvinyl alcohol resin, and hardening accelerator composition.

[0100] 除结晶水之外，这些造型用组合物优选基本上不含水分，还优选为粉末状。 [0100] In addition to the water of crystallization, these figure-forming composition is preferably substantially free of water, also preferably as a powder. 在造型用组合物用于建筑材料时，由于会让石膏粉末与水等混合并充分搅拌，使其迅速溶解，所以不会因原料即石膏粉末的粒度带来什么大问题。 Forming composition used in building materials, due to make mixing gypsum powder and water and stir to dissolve rapidly, so it will not cause any major problems namely raw gypsum powder particle size brings. 本发明的造型用组合物也并非必须成为泥浆状，所以优选钙类物质粉末的粒度大致相同。 Styling compositions of the present invention is not to be become muddy, so the calcium-based material powder particle size is preferably substantially the same. 从这一点来看，本发明的钙类物质可以是： 在根据JISR1619 (用液体沉积摄影法对细陶瓷颗粒的粒度分布进行测试的方法）进行粒度分布测试的情况下，在基于最大值分布士10%的粒度分布范围内，含有50重量％以上的钙类物质分子；优选含有70重量％以上的钙类物质分子；更优选85重量％以上的钙类物质分子；还优选95重量％以上的钙类物质分子。 From this point of view, the calcium-based material of the present invention may be: in the case of particle size distribution measurement according JISR1619 (photography method using a liquid deposition of fine ceramic particles size distribution of the test method), based on the maximum points Mr Buxton the particle size distribution of 10%, the molecule contains calcium-based material of 50 wt% or more; preferably 70 wt% or more of calcium-based material of the molecule; more preferably 85 wt% or more of calcium-based material molecules; and further preferably 95 wt% or more of calcium-based material molecules. 可通过反复进行筛选原料粉末的作业来获得这种分布。 By repeatedly screening the raw material powder to obtain such a distribution job.

[0101] 本发明中，造型用组合物中的钙类物质优选为石膏。 [0101] The present invention, the molding composition using calcium-based material is preferably gypsum. 石膏可以是α型半水石膏、 β型半水石膏或者该二者的混合物，优选α型半水石膏。 Gypsum can be α-hemihydrate gypsum, a mixture of β-hemihydrate gypsum, or the two, preferably α-hemihydrate gypsum. 因为α型半水石膏比β型半水石膏的水分少，可与更少的水形成混炼状态，从而能促进固化。 Because less water than α-hemihydrate gypsum β-hemihydrate gypsum, with less water to form a kneaded state, which can promote curing. 此外，优选采用安息角较小的半水石膏，从而可在成型时使粉末均勻扩散，所述安息角是指粉末能形成斜面的最大倾角。 In addition, preferred to use a smaller angle of repose hemihydrate gypsum, which can make the molding powder evenly spread, the rest angle refers to the powder to form a maximum angle of the slope. 从这一点来看，半水石膏（或造型用组合物）的安息角可以为30°〜45°，优选35°〜 40°。 From this point of view, hemihydrate gypsum (or figure-forming composition) angle of repose for 30 ° ~45 °, preferably 35 ° ~ 40 °.

[0102] 此外，对于本发明的聚乙烯醇树脂没有特别限制，也可以按需要采用公知的聚乙烯醇树脂（聚乙烯醇（-[c(OH)HCH2) ]η_)或适当具有官能团的聚乙烯醇树脂）。 [0102] In addition, there is no particular limitation on the polyvinyl alcohol resin of the present invention may also be needed by a known polyvinyl alcohol resin (polyvinyl alcohol (- [c (OH) HCH2)] η_) or appropriate functional group having a poly vinyl alcohol resins). 聚乙烯醇树脂可以采用皂化物或其衍生物，通常情况下，该皂化物是通过碱或酸等皂化催化剂皂化聚醋酸乙烯脂的低级醇溶液而形成的。 Saponified polyvinyl alcohol resin or derivatives thereof may be employed, In general, the lower alcohol solution is saponified by an alkali or acid catalyst saponification of polyvinyl acetate saponification formed. 聚乙烯醇树脂也可以采用具有能与醋酸乙烯酯共聚的单体和与醋酸乙烯酯形成共聚物的皂化物等。 Polyvinyl alcohol resin may be used having a vinyl acetate with a monomer copolymerizable with vinyl acetate and saponification and the like to form a copolymer. 作为这种能与醋酸乙烯酯共聚的单体，可以是乙烯、丙烯、异丁烯、α -辛烯、α -十二烯、α -十八烯等烯烃类；丙烯酸、甲基丙烯酸、 丁烯酸、马来酸、马来酸酐、衣康酸等不饱和酸类或他们的盐或单烷基酯或二烷基酯等；丙烯腈、甲基丙烯腈等腈类；丙烯酰胺、甲基丙烯酰胺等酰胺类；乙烯基磺酸、烯丙基磺酸、甲基烯丙基磺酸等烯烃磺酸类或它们的盐；烷基乙烯醚类；N-丙烯酰胺甲基三甲基氯化铵； 三甲基烯丙基氯化铵；二甲基二烯丙基氯化铵；二甲基烯丙基乙烯基酮；N-乙烯基吡咯烷酮；氯乙烯；偏二氯乙烯；聚氧乙烯(甲基）烯丙醚；聚氧丙烯（甲基）烯丙醚等的聚氧化烯（甲基）烯丙醚；聚氧乙烯（甲基）丙烯酸酯；聚氧丙烯（甲基）丙烯酸酯等的聚氧化烯(甲基）丙烯酸酯；聚氧乙烯（甲基）丙烯酰胺；聚氧丙烯（甲基）丙烯酰胺等的聚氧亚烷基（甲基）丙烯酰胺；聚氧乙烯（ι-(甲基）丙烯酰胺-ι，ι-二甲基丙基）酯；聚氧乙烯乙烯醚；聚氧丙烯乙烯醚；聚氧乙烯烯丙基胺；聚氧丙烯烯丙基胺；聚氧乙烯乙烯基胺；聚氧丙烯乙烯基胺等。 As such copolymerizable with the vinyl acetate monomer may be ethylene, propylene, isobutylene, α - octene, α - dodecene, α - olefins such octadecene; acrylic acid, methacrylic acid, crotonic acid , maleic acid, maleic anhydride, itaconic acid and other unsaturated acids or their salts or esters of mono-alkyl or di-alkyl esters; acrylonitrile and methacrylonitrile nitriles; acrylamide, methacrylamide amides, such as; vinyl sulfonic acid, allyl sulfonic acid, methallyl sulfonic olefin sulfonic acids or salts thereof; alkyl vinyl ethers; N- trimethylammonium chloride-methyl acrylamide ammonium; trimethyl ammonium chloride; diallyl dimethyl ammonium chloride; -dimethylallyl vinyl ketone; N- vinylpyrrolidone; chloride; vinylidene chloride; polyoxyethylene (meth) allyl ether; polyoxypropylene (meth) allyl ether, polyoxyalkylene (meth) allyl ether; polyoxyethylene (meth) acrylates; polyoxypropylene (meth) acrylates and other polyoxyalkylene (meth) acrylates; polyoxyethylene (meth) acrylamide; polyoxypropylene (meth) acrylamide and the like of polyoxyalkylene (meth) acrylamide; Polyoxyethylene (ι - (meth) acrylamides -ι, ι- dimethylpropyl) ester; polyoxyethylene vinyl ether; polyoxypropylene vinyl ether; polyoxyethylene allylamine; polyoxypropylene allylamine; polyoxyethylene vinyl amine; polyoxypropylene vinylamine and the like. 其中，优选采用醋酸乙烯的均聚物的皂化物；醋酸乙烯和乙烯、不饱和酸或它们的盐、烷基酯、烯烃磺酸或它们的盐的共聚物皂化物。 Among them, vinyl acetate is preferably used a homopolymer of saponified; vinyl acetate and ethylene, unsaturated acid or salts thereof, alkyl ester, an olefin sulfonic acid or a salt thereof saponified copolymers.

[0103] 与建筑材料等不同的是，在本发明中，不需要将造型用组合物放到模具中，此外也不需要混炼，所以未对聚乙烯醇树脂的皂化度和平均聚合度作特别限定。 Et al [0103] and building materials is different, in the present invention, need not be placed in a mold-forming composition, in addition does not require kneading, it is not the degree of saponification of the polyvinyl alcohol resin and the average degree of polymerization for particularly limited. 另一方面，因为皂化度不足70摩尔％时就不能提高立体造型的机械硬度，所以皂化度优选为70摩尔％以上， 更优选为80摩尔％〜99. 5摩尔％。 On the other hand, because the degree of saponification is less than 70 mol% can not improve the hardness of the three-dimensional shape of the machine, so that the degree of saponification is preferably not less than 70 mol%, more preferably 80 mol% ~99. 5 mol%. 对于聚乙烯醇树脂的平均聚合度，由于不足2Χ IO2时泥状物的粘度较低，而超过3Χ IO3时泥状物的粘度又过高，难以溶于水，所以聚合度例如为2 X IO2〜3 X IO3,也可以为5 X IO2〜2. 5 X 103。 For the average degree of polymerization of polyvinyl alcohol resin, due to insufficient 2Χ IO2 sludge viscosity is low, and more than 3Χ IO3 sludge viscosity too high again, it is difficult to dissolve in water, so the degree of polymerization, for example, 2 X IO2 ~3 X IO3, may be a 5 X IO2~2. 5 X 103. 如上所述，本发明中不需将造型用组合物放到模具中，也不需要混炼，所以聚乙烯醇树脂的聚合度还可以为3 X IO3〜1 X 104。 As described above, the present invention does not need the molding composition into a mold, does not require mixing, so the degree of polymerization of the polyvinyl alcohol resin can also 3 X IO3~1 X 104. 若聚合度太小，则会在向造型用组合物加水使之成泥浆状时产生石膏沉淀，但因本发明的造型用组合物不需要形成泥浆状，所以优选粘度较低且易溶于少量水的聚乙烯醇树脂，其聚合度可以为5X10〜1.9Χ102，也可以为1Χ102〜1.5Χ102。 If the polymerization degree is too small, then the addition of water to make it into a shape like slurry composition is produced by precipitation of gypsum, but the shape of the present invention does not need to form a slurry-like composition, it is preferably a low viscosity and is easy to dissolve in a small amount aqueous polyvinyl alcohol resin, a polymerization degree may 5X10~1.9Χ102, may be a 1Χ102~1.5Χ102. 可按照公知方法通过调整反应时间或反应条件来控制聚合度或分子量。 In accordance with a known method by adjusting the reaction conditions, the reaction time or to control the degree of polymerization or molecular weight.

[0104] 聚乙烯醇树脂完全皂化时的皂化度可以为90摩尔％以上且99. 5摩尔％以下， 更优选为98. 5摩尔％以上且99. 5摩尔％以下。 [0104] saponification degree of complete saponification polyvinyl alcohol resin may be 90 mol% and 99.5 mol% or less, more preferably 98.5 mol% and 99.5 mol% or less. 聚乙烯醇树脂的粘度优选为IX 10〜 2X IOmPa · S。 Polyvinyl alcohol resin preferably has a viscosity IX 10~ 2X IOmPa · S. 可以按照JIS等规格（如JISK7367)来测试粘度。 JIS, and other specifications can follow (eg JISK7367) to test the viscosity.

17[0105] 聚乙烯醇树脂可以是聚乙烯醇树脂自身，也可以是引入了官能团的聚乙烯醇衍生物树脂。 17 [0105] Polyvinyl alcohol resin may be polyvinyl alcohol resin itself, it may be introduced into a derivative of a polyvinyl alcohol resin functional group. 此外，也可以是部分引入了官能团的聚乙烯醇衍生物树脂、还可以是多种聚乙烯醇树脂的混合物。 In addition, it can be part of the introduction of the polyvinyl alcohol derivative resin functional group may also be a mixture of polyvinyl alcohol resin. 所述官能团可以是乙酰乙酰基、甲硅烷基、季铵盐基、羧酸基、羧酸的无机盐基、磺酸基、磺酸的无机盐基、酮基、巯基、氨基；也可以是它们中的一种或两种以上。 The functional group may be an acetoacetyl group, a silyl group, a quaternary ammonium salt group, a carboxylic acid group, inorganic acid group, a sulfonic acid group, a sulfonic acid group of an inorganic salt, a ketone group, a mercapto group, an amino group; it can be Among them, one or two or more. 其中， 优选乙酰乙酰基或甲硅烷基，最优选的是具有乙酰乙酰基官能团。 Among them, an acetoacetyl group or a silyl group, most preferably having acetoacetyl functional groups. 官能团的比例为：可以用官能团置换所有的羟基（-0H)，也可以用官能团置换5%〜95%的羟基，还可以用官能团置换10%〜20%、70%〜90%或30%〜70%的羟基。 The proportion of functional group: You can use all of the hydroxyl groups replaced with a functional group (-0H), may also be replaced by a functional group 5 ~ 95% of the hydroxyl groups, the functional groups can also be replaced by 10% ~ 20%, 70% or 30% to ~ 90% 70% of the hydroxyl groups. 尤其是分子内具有乙酰乙酰基的聚乙烯醇树脂，其可通过分子内具有的乙酰乙酰基，与固化促进剂等含有的金属离子形成螯合物，从而用少量的水分就能迅速使造型用组合物达到规定的硬度。 Especially polyvinyl alcohol resin having an acetoacetyl group in the molecule, which may be by acetoacetyl group in the molecule, and a curing promoting agent and a metal ion chelate containing formation, whereby with a small amount of water can quickly make stereolithography The composition reaches a predetermined hardness. 根据具体情况，可按照有机合成中的常规方法将上面所述的官能团引入聚乙烯醇树脂，也可按照有机合成中的常规方法控制引入的官能团的种类和比例。 Depending on the circumstances, in accordance with conventional methods of organic synthesis in the above functional group into a polyvinyl alcohol resin, but also can control the type and proportion of functional groups introduced in accordance with conventional methods of organic synthesis.

[0106] 当所述钙类物质和所述聚乙烯醇树脂的总重量为100重量份时，所述聚乙烯醇树脂的重量份为2重量份〜8重量份。 [0106] when the total weight of the calcium-based material and the polyvinyl alcohol resin is 100 parts by weight, the parts by weight of the polyvinyl alcohol resin is 2 parts by weight of ~ 8 parts by weight. 如后面的实施例所述，聚乙烯醇树脂优选为3重量份〜 7重量份，也可以是3重量份〜6重量份或4重量份〜7重量份，还可以是4重量份〜6重量份、4. 5重量份〜5. 5重量份。 As described in Example described later, a polyvinyl alcohol resin is preferably 3 parts by weight to 7 parts by weight, and may be 3 parts by weight parts by weight of 4 ~ 6 ~ 7 parts by weight or parts by weight, 4 parts by weight can also be ~ 6 wt. parts, 4.5 parts by weight of ~ 5. 5 parts by weight. 若聚乙烯醇树脂太少，则不能获得适当的硬度。 If the polyvinyl alcohol resin is too small, it can not get proper hardness.

[0107] 本发明的造型用组合物可以是分别含有所述聚乙烯醇树脂和钙类物质的组合物，也可以是钙类物质和聚乙烯醇树脂的混合物。 [0107] molding compositions of the present invention may be separately containing the polyvinyl alcohol resin and composition of calcium-based material can be a mixture of calcium-based material and polyvinyl alcohol resin. 不管采用何种造型用组合物，都优选为粉末状，粉末的大小优选与上述范围相同。 Regardless of the figure-forming composition, are preferably in powder form, the powder size is preferably the same as the above-mentioned range.

[0108] 本发明的固化促进剂是从二水石膏、碱金属硫酸盐、碱土类金属硫酸盐、碱金属氯化物盐、碱土类金属氯化物盐、无机酸的铵盐、明矾类构成的群组中选择出的一种或两种以上的固化促进剂。 [0108] Group curing accelerator of the present invention is prepared from dihydrate gypsum, alkali metal sulfates, alkaline earth metal sulfates, alkali metal chloride salt, alkaline earth metal chloride salt, inorganic acid ammonium salts, alum class consisting of selected from the group of one or more kinds of curing accelerators. 碱金属硫酸盐可以是硫酸钠、硫酸钾。 The alkali metal may be sodium sulfate, potassium sulfate. 碱土类金属硫酸盐可以是硫酸镁、 硫酸钙和硫酸钡。 Alkaline earth metal may be magnesium sulfate, calcium sulfate and barium sulfate. 碱金属氯化物盐可以是氯化锂、氯化钠和氯化钾。 Alkali metal chloride salt may be lithium chloride, sodium chloride and potassium chloride. 碱土类金属氯化物盐可以是氯化镁和氯化钙。 Alkaline earth metal chloride salt may be magnesium chloride and calcium chloride. 无机酸的铵盐可以是盐酸铵（ammonium hydrochloride)，明矾类可以是十二水硫酸铝钾（十二水硫酸钾铝MlK(SO4)2 · 12H20等钾明矾；AlNa(SCM)2 · 12H20 等钠明矾；NH4Al (SO4)2 ·12Η20等铵明矾。其中，优选是从硫酸镁、氯化钠、硫酸钠、硫酸钙构成的群组中选择出的一种或两种以上。此外，优选采用二水石膏和除二水石膏以外的其他成分，即，硫酸镁、氯化钠、硫酸钠以及硫酸钙所构成的群组中选择出的一种或两种以上。固化促进剂优选含有金属盐，因为这种固化促进剂在具有规定的官能团的聚乙烯醇之间形成螯合结构，可提高立体造型或骨模型的硬度。 Ammonium salts of inorganic acids can be hydrochloric acid, ammonium (ammonium hydrochloride), alum class can be twelve aluminum potassium sulfate (potassium aluminum twelve water MlK (SO4) 2 · 12H20 and other potassium alum; AlNa (SCM) 2 · 12H20 etc. sodium alum;. NH4Al (SO4) 2 · 12Η20 ammonium alum, etc. Among them, preferably selected from magnesium sulfate, sodium chloride, sodium sulfate, calcium sulfate group consisting of one or more of addition, is preferably used. gypsum and other components except for dihydrate gypsum, i.e., the group of magnesium sulfate, sodium chloride, sodium sulfate, calcium sulfate, and consisting of the selected one or two or more. Preferably the curing accelerator containing a metal salt , because such a curing accelerator between polyvinyl alcohol having a predetermined functional group forming a chelate structure, can increase the hardness of the bone model or three-dimensional shape.

[0109] 在添加固化促进剂的情况下，若钙类物质和聚乙烯醇树脂的总重量为100重量份，固化促进剂可以为0. 1重量份〜5重量份。 [0109] In the case of adding a curing accelerator, if the total weight of the calcium-based material and polyvinyl alcohol resin is 100 weight parts, a curing accelerator may be ~ 5 parts by weight 0.1 parts by weight. 当以二水石膏作为固化促进剂时，二水石膏的含量可以为0.5重量份〜5重量份。 When in gypsum as a curing accelerator, gypsum content may be 0.5 parts by weight ~ 5 parts by weight. 当固化促进剂中不含二水石膏时，若石膏和聚乙烯醇树脂的总重量为100重量份，固化促进剂的含量可以为0. 1重量份〜5重量份，优选为0. 1 重量份〜3重量份，更优选为0. 3重量份〜2重量份，还优选为0. 4重量份〜1. 5重量份。 When the curing accelerator does not contain gypsum, gypsum, and if the total weight of the polyvinyl alcohol resin is 100 parts by weight, the content of the curing accelerator may be 0.1 ~ 5 parts by weight parts by weight, preferably from 0.1 wt. parts ~ 3 parts by weight, more preferably 0.3 ~ 2 parts by weight parts by weight, further preferably 0.4 parts by weight of ~ 1. 5 parts by weight.

[0110] 可采用造型成形用组合物中的公知方法，将固化促进剂加在造型成形用组合物中。 [0110] The composition can be molded in the shape of the known methods, the curing accelerator added in the shape molding compositions. 在可保持本发明造型成形用组合物的功能的范围内，本发明的造型成形用组合物也可采用上述之外的公知成分。 In the present invention, the shape can be maintained by molding the composition within the scope of functions, the shape of the present invention may also be employed for molding compositions known component other than the above.

[0111] 当按照快速原型法（RP法）制造立体造型时，在用于形成骨模型的立体造型的制造方法中，通常是采用上述任意一种粉末状造型用组合物。 [0111] When in accordance with rapid prototyping (RP method) manufacture three-dimensional modeling, in the method for forming a three-dimensional shape of a bone model, usually employ any of the above powdery molding compositions. 由于采用了这种造型用组合物，所以即使重叠多个添加有少量水分（水、交联剂水溶液、RP装置中所采用的公知的粘结剂水溶液等）的层，也可迅速形成具有足够硬度而保持该中间产品形状不变的立体造型。 As a result of this figure-forming composition, even if a plurality of superimposed small amount of water added (water, cross-linker solution, RP means employed known binder aqueous solution) layer, may be formed to have fast enough the hardness of the intermediate product while maintaining the same shape three-dimensional modeling. 此外，优选用少量的水粘结上下相邻并具有一定硬度的各层来形成一体式立体造型。 In addition, with a small amount of water is preferably bonded with a certain hardness and vertically adjacent layers to form an integrated three-dimensional shape. 如果只是采用现有技术的造型用组合物，则不能获得具有上述特性的立体造型，但采用本发明的造型用组合物，则可实现本发明的立体造型制造方法。 If only the shape of the prior art composition, three-dimensional shape can not be obtained with the above characteristics, but the shape of the present invention, the composition can be three-dimensional modeling method of the present invention are achieved.

[0112] 具体而言，用于形成骨模型的立体造型的制造方法是一种再现物体形状的立体造型制造方法，该方法包括如下工序。 [0112] Specifically, the manufacturing method for forming a three-dimensional shape of the bone model is a method for producing a three-dimensional figure reproducing the shape of the object, the method comprising the following steps. 剖面形状获得工序（步骤Al)：根据物体的三维形状信息，获得所述三维形状在分成多层后得到的各层的剖面形状信息；第一剖面（断层）塑像工序（步骤A2-1)：根据在所述剖面形状获得工序中获得的所述剖面形状信息，读取第一层的剖面形状信息，再根据读取的信息，利用造型用组合物形成其上再现有所述剖面形状的第一剖面造型；第二剖面（断层）塑像工序（步骤A2-2)：根据在所述剖面形状获得工序中获得的所述剖面形状信息，读取位于所述第一剖面造型上层的第二层的剖面形状信息， 再根据读取的信息，利用造型用组合物形成第二剖面造型，该第二剖面造型上再现有所述剖面形状并重叠在所述第一剖面造型上；立体造型获得工序（步骤A2-n)：其用于获得再现有物体形状的立体造型，该工序与所述第二剖面塑像工序相同，反复执行如下工序，即，根据在所述剖面形状获得工序中获得的所述剖面形状信息，读取所述欲形成层的剖面形状信息，再根据读取的信息，利用造型用组合物形成所述层的剖面造型，该造型上再现有所述剖面形状，并重叠在前一工序中所获得的剖面造型上。 Cross-sectional shape obtaining step (step Al): According to the three-dimensional shape information of the object, obtaining the sectional shape of each layer in the three-dimensional shape information obtained into a multilayer; a first cross-sectional (tomographic) statue step (step A2-1): According to the information obtained in the cross-sectional shape of the cross-sectional shape obtaining step, the cross-sectional shape to read information on the first layer, according to the information read using the figure-forming composition is formed which has a cross-sectional shape on the reproducing section A cross-sectional shape; a second cross-sectional (tomographic) statue step (step A2-2): In accordance with the cross-sectional shape of the cross-sectional shape information obtained in the obtaining step, reading said first cross-sectional shape of the second upper layer The cross-sectional shape information, then the information read by the second cross-sectional shape is formed by molding a composition, which has a second cross-sectional shape of the cross-sectional shape and reproducing superimposed on the first cross-sectional shape; three-dimensional figure obtaining step The reproduction for obtaining three-dimensional shape of an object shape, the same procedure with the second cross-sectional figure forming step, the following step is repeatedly executed, i.e., in the cross-sectional shape obtained according to step obtained: (step A2-n) said cross-sectional shape information, read the cross-sectional shape information layer is to be formed, according to the information read using the cross-sectional shape of said molding layer forming composition, there is reproduced on the shape of the cross-sectional shape, and overlap cross-sectional shape obtained in the previous step on. 其中，所述剖面造型形成工序中至少一个以上的工序包括如下两工序。 Wherein the step of at least one or more two-step process comprising forming the cross-sectional shape. 造型用组合物层获得工序：使上述任何一个工序中所述的造型用组合物的粉末为层状，形成造型用组合物层；水分添加工序：根据该层的剖面形状信息，将水分添加在所述造型用组合物层获得工序中所形成的造型用组合物层上，这样， 使所述造型用组合物层的规定位置润湿。 Figure-forming composition layer obtaining step: a step shape so that any of the above powder composition layer, forming a figure-forming composition layer; water adding step: based on the cross-sectional shape of the information layer, moisture added The modeling process modeling obtained in the form of the composition layer on the composition layer, so that the shape of a predetermined position wetting composition layer. 下面，具体说明各工序。 Next, a specific description of each step.

[0113] 剖面形状获得工序（步骤Al)是指，用于根据物体的三维形状信息，获得所述三维形状在分成多层后得到的各层的剖面形状信息的工序。 [0113] cross-sectional shape obtaining step (step Al) refers, for the three-dimensional shape information of the object, a step to obtain cross-sectional shape of each layer of the three-dimensional shape information in the divided multilayer obtained. 对于上述立体造型的制造方法，用于形成骨模型的立体造型的制造方法的优选实施方式为，所述各层的剖面形状信息中包括各层的颜色识别信息，在所述水分添加工序中按照所述颜色识别信息添加含有着色成分的水分。 For the preferred embodiment of the method of manufacturing the above-described three-dimensional modeling, three-dimensional modeling method for producing a bone model was used to form the cross-sectional shape information of the respective layers included in the color identification information of each layer, in accordance with the water adding step The color identification information Add water containing a coloring ingredient.

[0114] 可通过所谓的快速原型法中采用的公知装置使工序等程序化，容易地实施所述用于形成骨模型的立体造型的制造方法。 [0114] and other procedures can make the step by known means of a so-called rapid prototyping method employed easily implement the manufacturing method for forming a three-dimensional shape of the bone model. 具体而言，可通过安装有快速原型法用程序的计算机等容易地实施该方法。 Specifically, by installing rapid prototyping method using computer programs such as the implementation of the method easily. 该计算机具有输入输出部、CPU等控制部、运算部以及存储器，通过接口等输入输出部与用于制造立体造型的立体造型制造部相连接。 The computer has input and output unit, CPU, etc. The control unit, arithmetic unit and a memory unit through the interface is connected to the input and output for manufacturing three-dimensional modeling of three-dimensional shape of the manufacturing department. 立体造型制造部包括： 活动式工作台，其可根据所述计算机输出的指令而上下移动，以形成立体造型；造型用组合物层形成部，为了在所述活动式工作台上形成造型用组合物层，其根据所述计算机输出的指令，从造型用组合物的粉末储存部取出造型用组合物的粉末，形成造型用组合物层；印刷部，其根据计算机输出的指令，将水或规定水溶液添加到所述造型用组合物层上。 Three-dimensional figure forming part comprises: a movable table, which can be the basis of the output from the computer command moves up and down to form a three-dimensional modeling; forming composition layer forming unit, in order to form the movable table with a combination of modeling layer, which according to the output of a computer instruction, from the shape out with a powder storage unit composition forming composition of the powder to form figure-forming composition layer; a printing unit which computer output instruction, water or provisions aqueous solution was added to the figure-forming composition layer.

[0115] 在剖面形状获得工序中，可先根据多张X射线照片等获得对象物的三维形状信息，再获得该三维形状的在分成由多层构成的剖面形状后的图像。 [0115] In the cross-sectional shape obtaining step, the information can be obtained three-dimensional shape of the object based on a plurality of X-ray photos, etc., and then obtain the three-dimensional shape of an image into a plurality of layers of the cross-sectional shape of the post. 植入物或人工骨的三维形状例如可按如下方式来获得。 Implant or artificial three-dimensional shape such as can be obtained as follows. 首先，为了获得用于填充缺损部分的植入物或人工骨，可通过计算机模拟与对象部位对称的骨的形状，从而获得对象物的三维形状信息，这是因为，通常情况下缺损部分具有原本大致呈左右对称形状的部分（如，右脚的骨骼与左脚的骨骼）。 First, in order to obtain for filling the defect part of bone or implant, the shape of the object by computer simulation and symmetrical bone portion, thereby obtaining a three-dimensional shape information of the object, this is because, typically having a defect portion originally substantially symmetrical shape portion (eg, right foot and left foot skeleton bones). 然后，例如在制造牙齿用植入物等情况下，患处自身形状可能不适宜再现，此时，可以以周围的牙齿或骨骼的形状作为参考，用3DCG(三维计算机图形技术）等描绘对象物的形状，并将其输入计算机，由此获得三维形状信息，此时，计算机也可根据该三维形状获得各剖面形状信息。 Then, for example, in the case of using the manufacturing dental implants, may be suitable for reproducing the shape of the lesion itself, at this time, or may be the shape of the bone around the teeth as a reference, by 3DCG (three-dimensional computer graphics), etc. drawing object shape, and entered into the computer, thereby obtaining a three-dimensional shape information, at this time, the computer can also be obtained for each cross-sectional shape information based on the three-dimensional shape. 具体而言，当来自指针设备的输入信号输入CPU时，CPU则根据输入的信号读取CD-ROM或硬盘等存储部中存储的控制程序。 Specifically, when the input signal is input from a pointing device CPU, CPU is based on the signal input reading CD-ROM or hard disk or other storage unit control program storage. 然后，CPU根据控制程序的指令，扫描存储部中存储的X射线照片图像等，集中多个扫描的二维图像，由此获得三维形状的图像。 Then, CPU control program according to the instruction, the storage unit stores the scanning X-ray photo images, etc., a plurality of scanning the two-dimensional images concentrated, thereby obtaining an image of the three-dimensional shape. 此时，因X 射线照片等中骨骼等部位和软组织等部位的颜色深浅不同，所以在扫描X射线照片而获得图像时，除了可通过颜色深浅大为不同的部位获得轮廓之外，还可通过判断该轮廓所包围部位的颜色深浅是否为规定值范围，或通过比较轮廓所包围部位之间的颜色深浅，来获得骨骼等部位和软组织等部位的图案信息，并将该信息存储起来。 At this time, due to X-ray photograph of bone and soft tissue and other parts and other parts of different shades, so when scanning X-ray photographs and obtain an image, in addition to the contour through shades can be obtained very different than the site, but also through Analyzing the profile surrounded by parts of the shades is a predetermined value range, or surrounded by comparing the outline color depth between the parts to get the bone and soft tissue and other parts and other parts of the pattern information, and the information is stored. 在获得三维形状的图像后， 例如，按照ζ轴（从地面到空中的方向）等某一方向将该三维形状切成薄片，从而获得多层中各层的剖面形状。 After obtaining the three-dimensional shape of the image, for example, according to the ζ-axis (the direction from the ground into the air) in a certain direction, etc. The three-dimensional shape sliced ​​to obtain a cross-sectional shape of each layer in the multilayer.

[0116] 当在骨模型上描绘等高线时，可根据获得的物体形状（制造的骨模型的形状）按照公知方法来分析高度，然后按照各高度间隔描绘等高线。 [0116] When contour lines are drawn on the bone model, in accordance with a known method to analyze the height according to body shape (the shape of a bone model produced) obtained, and then follow the contour lines are drawn for each height interval. 具体而言，快速原型法是通过重叠多层来制造立体造型的方法，因此，在形成各层时，可用颜色来划分各层的最下部或最上部。 In particular, rapid prototyping is a method for producing a multilayer by overlapping three-dimensional shape, and therefore, when forming the respective layers, the color can be used to divide the lowermost or uppermost layers. 例如，可在每隔2层〜100层时就对一层着色。 For example, at intervals of 2 ~ 100 layer on layer on layer of coloring. 这样，则可获得描绘有各适当高度的等高线的骨模型。 Thus, there is obtained the bone model depicting various appropriate height contours. 具体而言，各层的规定部分上均用着色剂或墨着色，或者，按照程序在规定的各层上形成添加有着色剂等的层，并按照该程序来制造模型。 Specifically, the provisions on the part of each layer are colored with a colorant or ink, or in accordance with the prescribed procedure on each layer is formed of layers added coloring agents, and in accordance with the program to make models.

[0117] 当在骨模型上描绘等高线时，例如可执行如下程序：设置获得的骨模型的方向(正面方向），使得其三维数据可显示在二维监视器中，并将网格应用在该二维数据上，然后在模型上描绘该网格。 [0117] When drawing contour lines on the bone model, for example, perform the following procedure: a direction (front direction) to set the bone model obtained, so that it can display three-dimensional data in a two-dimensional monitor, and grid On the two-dimensional data, and then describe the grid on the model.

[0118] 可根据来自指针设备等的输入信息适当调整各层的厚度，也可按照预先设定的值来控制各层的厚度。 [0118] to input information from the pointing device or the like appropriately adjusted according to the thickness of the layers may also be in accordance with a preset value to control the thickness of each layer. 若各层的厚度太厚，则不能获得精致的固化体，也不能通过印刷机构等将水滴添加到各层上来获得能保持形状的硬度。 If the thickness of each layer is too thick, the fine can not be obtained cured body, can not be added through the printing mechanism and other layers of water droplets to get up to maintain the shape of the hardness. 若各层的厚度太薄，则需要获得很多剖面造型，从而只会增加计算机硬件资源的负担，在形成造型时也需要花费较多的时间。 If the thickness of each layer is too thin, you need to get a lot of cross-sectional shape, which will only increase the burden on the computer's hardware resources, in the form modeling also takes more time. 从这一点来看，各层的厚度可以是IX IOym〜5mm，也可以是IXlO2Pm〜1mm。 From this point of view, the thickness of each layer can be IX IOym~5mm, may also be IXlO2Pm~1mm. 各层的厚度优选均勻，也可以不均勻。 The thickness of each layer is preferably uniform, and to be non-uniform.

[0119] 第一剖面塑像工序（步骤A2-1)是指，根据在所述剖面形状获得工序中获得的所述剖面形状信息，读取第一层的剖面形状信息，再根据读取的信息，利用造型用组合物形成其上再现有所述剖面形状的第一剖面造型。 [0119] The first cross-sectional figure forming step (step A2-1) refers, based on the cross-sectional shape of the cross-sectional shape information obtained in the obtaining step, reading the sectional shape information of the first layer, according to the read information by reproducing the shape formed thereon have a first cross-sectional shape of the cross-sectional shape of the composition.

[0120] 第二剖面塑像工序（步骤A2-2)是指，根据在所述剖面形状获得工序中获得的所述剖面形状信息，读取位于所述第一剖面塑像上层的第二层的剖面形状信息，再根据读取的信息，利用造型用组合物形成第二剖面造型，该第二剖面造型上再现有所述剖面形状，并重叠在所述第一剖面造型上。 [0120] The second cross-sectional figure forming step (step A2-2) refers, based on the information obtained in the cross-sectional shape of the cross-sectional shape obtaining step, reading said first cross-sectional figure of the upper cross-sectional view of the second layer shape information, then the information read by the second cross-sectional shape is formed by molding a composition, which has a second cross-sectional shape of the cross-sectional shape of the reproduction, and superimposed on the first cross-sectional shape.

[0121] 接下来，与所述第二剖面造型形成工序相同，反复执行如下工序：根据在所述剖面形状获得工序中获得的所述剖面形状信息，读取所述欲形成层的剖面形状信息，再根据读取的信息，利用造型用组合物形成所述层的剖面造型，该造型上再现有所述剖面形状，并重叠在前一工序中所获得的剖面造型上。 [0121] Next, the second cross-sectional shape is formed with the same process repeated the following steps: according to the cross-sectional shape information obtained in the cross-sectional shape obtained in the step of reading the cross-sectional layer to be formed shape information , according to the information read using the composition for forming a cross-sectional shape of said molding layer, there is the cross-sectional shape reproducing the shape, and the cross-sectional shape of an overlap obtained in the previous step.

20[0122] 在再现物体形状的立体造型的制造方法中，所述剖面塑像工序中至少一个以上的工序包括如下两工序。 20 [0122] In the method for reproducing three-dimensional shape of the object shape, the cross-sectional figure of at least one more step in the process includes the following two steps. 造型用组合物层获得工序：使上述任何一项所述造型用组合物的粉末为层状，形成造型用组合物层；水分添加工序：根据该层的剖面形状信息，将水分添加在所述造型用组合物层获得工序中所形成的造型用组合物层上，这样，使所述造型用组合物层的规定位置润湿。 Figure-forming composition layer obtaining step: to enable any of the preceding molding powder composition layer, forming figure-forming composition layer; water adding step: based on the cross-sectional shape of the information layer, adding water in the modeling process modeling obtained in the form of the composition layer on the composition layer, so that the shape of a predetermined position wetting composition layer.

[0123] 下面，说明剖面造型形成工序的实施例。 [0123] Next, embodiments of a cross-sectional shape forming step. 各剖面造型形成工序中，CPU接收控制程序的指令，读取造型用组合物层的厚度信息，并从输入输出装置输出该信息。 Each cross-sectional shape forming step, CPU control program receives an instruction to read the information on the shape of the thickness of the composition layer, and outputs the information output from the input means. 接收到该厚度信息的立体造型制造部根据所述计算机的指令，使活动式工作台向下移动。 Receiving the information on the thickness of three-dimensional modeling of manufacturing unit according to the instructions of the computer, so that movable stage is moved downward. 此时，向下移动的距离与造型用组合物层的厚度相对应。 At this time, the downward movement distance corresponding to the thickness and shape composition layer. 该上下移动的距离信息也从计算机中输出，工作台根据该移动距离信息进行移动。 The up and down movement distance information is also output from the computer, the table moves according to the movement distance information. 当各层的厚度相同时，立体造型制造部的存储部则存储该信息，并可在形成各层时使用相同的信息。 Use the same information when the thickness of the layers of the same, three-dimensional figure forming part of the storage unit stores the information, and the layers are formed.

[0124] 接下来，CPU接收控制程序的指令，例如，读取造型用组合物层的厚度信息，并运算适于形成造型用组合物层所需的造型用组合物的量，然后从输入输出部输出。 [0124] Next, the CPU receives commands of a control program, for example, the thickness of the read shape information layer composition and figure-forming composition layer operation desired amount of figure-forming composition suitable for forming, from the input and output unit output. 该量可以是固定的，当其被传输到立体造型制造部后，立体造型制造部的存储部则将该信息存储起来， 从而在形成各层时可使用相同的信息。 This amount may be fixed, when it is transferred to the three-dimensional figure forming part, three-dimensional figure forming part of the information storage unit is stored, so that when the layers are formed using the same information. 立体造型制造部在接收到该造型用组合物层的信息后，根据所述计算机输出的指令，通过造型用组合物形成部将造型用组合物的粉末从造型用组合物的粉末储存部中取出，并将该粉末放在工作台上。 Three-dimensional modeling of manufacturing unit in receiving the molding composition layer with the information, the computer output in accordance with the instructions, by molding forming part composition will shape out with a powder storage unit composition from the shape of the powder composition and the powder on the bench. 立体造型制造部可通过使涂刷器或抹刀适当移动来控制造型用组合物层，使其均勻。 Three-dimensional figure forming part can be achieved by moving a squeegee or trowel appropriate to control the figure-forming composition layer, making it uniform. 这样，可在活动式工作台上（已经形成有层时，则是在先形成的造型用组合物层上）形成造型用组合物层。 In this way, the movable table (when modeling layer has been formed, it is previously formed on the composition layer) forming composition layer.

[0125] 接下来，CPU接收控制程序的指令，读取各层的剖面形状或图案信息，然后从输入输出部输出。 [0125] Next, CPU receives a control instruction program, the reading of each layer cross-sectional shape or pattern information, and then output from the input-output unit. 立体造型制造部根据计算机输出的指令使印刷部工作，将水或规定水溶液(水、交联剂水溶液、快速原型法所采用的粘结剂水溶液等）添加到所述造型用组合物层上。 Three-dimensional figure forming part of the printing department of computer output according to the instructions, the provisions of the water or aqueous solution (water, cross-linker solution, rapid prototyping solution used in adhesives, etc.) added to the figure-forming composition layer. 采用公知的印刷机控制机构就可容易地实现这种结构。 Using a known press control mechanism can be easily realized this structure. 此外，此时所添加的水或水溶液的组成、浓度、量等各条件都可适当调整。 In addition, water or an aqueous solution of the composition, concentration, volume, and other conditions can be added at this time is appropriately adjusted. 例如，从指针设备等输入上述各条件的信息，并将输入的信息存储在计算机的存储部中，根据所述各条件的信息，CPU读取需要的信息并通过运算部进行运算，控制印刷部的运转。 For example, each of the input information from the pointing device and other conditions, and inputs the information stored in the storage unit of the computer, each based on the information of the condition, the CPU reads the required information and calculation by the arithmetic unit, the printing control unit operation. 此外，也可采用普通的印刷技术，在印刷部中添加水滴等来替代墨。 In addition, it can be an ordinary printing technology, add water droplets in the printing unit instead of ink. 所述造型用组合物层中所添加的液体粘结材料既可以是有机物又可以是无机物。 The figure-forming composition layer by adding a liquid binder material may be both organic and inorganic may be. 代表性的有机粘结材料是聚合树脂或聚碳硅氮烷这样的陶瓷前体。 Representative organic binder material is a polymeric ceramic precursor such as polycarbosilane resin or silazane. 无机粘结剂用在粘结剂与最终物配合使用的情况下，通常采用硅石。 In the case of an inorganic binder binder used in conjunction with the final composition, usually silica.

[0126] 通常情况下，会在形成各层的阶段反复执行如下动作：加入与促进水合反应所需水分量相同或更多的水分，并使其干燥。 [0126] In general, repeatedly performing the following actions at the stage of formation of layers: join and promote the same amount of water required for the hydration reaction or more of water, and allowed to dry. 但本发明的立体造型制造方法（本发明的固化物制造方法）中，不需要在上述阶段充分进行石膏的水合反应。 However, the method of manufacturing three-dimensional figure (cured product of the manufacturing method of the present invention) of the present invention, the above-described need not sufficiently phase hydration reaction of gypsum. 因此，在各剖面塑像工序中， 例如，当造型用组合物充分水合所需要的水分量为100重量份时，所添加的水分量例如可以是1重量份〜50重量份，也可以是1重量份〜20重量份、2重量份〜10重量份或3重量份〜5重量份。 Thus, in the cross-sectional figure forming step, for example, the amount of water when fully hydrated molding composition required for 100 parts by weight, the amount of water may be added, for example, 1 ~ 50 parts by weight parts by weight, may be 1 wt ~ 20 parts by weight parts, 2 parts by weight or parts by weight of 3 ~ 10 parts by weight of ~ 5 parts by weight. 这样少量的水分不会让石膏的水合反应充分进行。 Such small amounts of moisture will not let the hydration reaction of gypsum sufficiently. 但可以通过它迅速获得其硬度足够维持最低限度硬度的层。 But we can get through it quickly hardness minimum hardness layer is sufficiently maintained. 此外，因水分量较少，所以可防止水向不希望的部分扩散，从而可获得具有所需剖面结构的层。 In addition, due to the amount of water is less, water can be prevented from diffusing to the undesirable portion, thereby obtaining layers having desired cross-sectional configuration. 尤其是在获得具有两种以上图案的剖面结构等情况下，不让两种以上的水或水溶液混合是非常重要的，通过添加少量的水分，则可有效地防止两种以上的水或水溶液混合。 Especially in obtaining a cross-sectional structure having two or more patterns, etc., to prevent mixing of two or more water or an aqueous solution is very important, by adding a small amount of water, it can be effectively prevented from mixing with water or an aqueous solution of two or more . [0127] 在反复执行剖面塑像工序之后，优选进行干燥，直到获得的层压体具有一定程度的硬度。 [0127] After the cross-sectional figure forming step is repeatedly performed, preferably dried until a laminate having a degree of hardness. 干燥可在低温高湿的环境（例如，湿度0%〜10%，温度50°C〜2X102°C)下进行， 也可在常温常压的环境下进行。 Dried at low temperatures and high humidity environment (eg, humidity of 0% ~ 10%, temperature 50 ° C~2X102 ° C) carried out, can be carried out at ambient temperature and pressure conditions. 常温常压下的干燥时间可根据获得的立体造型的大小、水分含量、各层的厚度等适当调整，如1分钟〜1小时、5分钟〜3 X 10分钟或5分钟〜2 X 10 分钟。 Drying time under normal temperature and pressure can be adjusted to obtain the size of the three-dimensional shape, moisture content, etc. according to the thickness of each layer, such as one minute for ~ 1 hour, 5 minutes ~3 X 10 minutes or 5 minutes ~2 X 10 minutes. 即，本发明在采用快速原型法时，采用了含有较多聚乙烯醇树脂的造型用组合物，所以可迅速获得硬度较高的立体造型。 That is, the present invention when using rapid prototyping, modeling using a polyvinyl alcohol resin contains more compositions, it is possible to obtain three-dimensional modeling of high hardness quickly. 在这一阶段，造型用组合物不需要含有足够的水分，因而可大大缩短干燥时间。 At this stage, forming composition need not contain sufficient moisture, which can greatly shorten the drying time. 干燥后则可获得再现有物体形状的立体造型。 After drying will receive a reproduction of a three-dimensional shape of the object modeling. 干燥优选在排气工序中进行，例如，通过减压来排气等，由此能极其迅速地进行干燥。 Drying step is preferably carried out in the exhaust gas, e.g., under reduced pressure to exhaust the like, whereby drying can be performed extremely rapidly.

[0128] 按照上述方式获得的立体造型很有可能未进行石膏的水合反应。 [0128] three-dimensional figure obtained in the manner described above is not likely to be the hydration reaction of gypsum. 因此，与充分进行了水合反应而获得的立体造型相比，前者的硬度可能较低。 Thus, a three-dimensional shape with sufficiently obtained compared to the hydration reaction, the hardness of the former may be lower. 但是，通过在水分较少的状态下来形成图案，可防止水分扩散到不希望的部分上而导致该部分固化。 However, by forming a pattern of state less water down to prevent moisture diffusion to the unwanted portion causes the partially cured. 因此，可以说该立体造型的制造方法对于迅速制造具有精致外形的立体造型是非常有用的。 Therefore, a method of manufacturing three-dimensional modeling of the three-dimensional modeling for rapid manufacturing has exquisite appearance is very useful. 此外，因为水化反应未充分进行，所以尽管按照上述方式所获得的立体造型具有精巧的外形，但可以预见立体造型的硬度较低。 In addition, since the reaction was not sufficiently hydrated, so despite having a compact shape in accordance with the three-dimensional shape obtained in the manner described above, but can be expected three-dimensional shape of the lower hardness. 因此，若想获得足够的硬度，可按照后述的固化物制造方法进行水合反应。 Therefore, to obtain sufficient hardness, the hydration reaction can be carried out in accordance with the manufacturing method cured later.

[0129] 如上所述，骨模型制造方法总体上是按照如下方式来获得固化物：S卩，将上述各工序中获得的立体造型浸渍在水或水溶液中，从而通过水分来促进石膏的水合反应，然后对造型进行干燥，由此获得具有足够硬度的固化物。 [0129] As described above, the bone model producing method is generally in the following manner to obtain a cured product: S Jie, immersing the three-dimensional shape obtained in the above step in water or an aqueous solution, thereby promoting the hydration reaction of gypsum by water , then dried shape, thereby obtaining a cured product having sufficient hardness.

[0130] 即，骨模型制造方法大致包括如下工序。 [0130] That is, the bone model producing method generally comprises the following steps. 石膏粉末除去工序（步骤Bi)：用于从按照上述任意一种立体造型制造方法获得的立体造型上，除去未固化的造型用组合物的粉末；水分添加工序（步骤B2)：用于将水分添加到所述石膏粉末除去工序中已除去粉末的立体造型上；干燥工序（步骤B3)：用于干燥在所述水分添加工序中添加有水分的立体造型。 Gypsum powder removing step (step Bi): from the three-dimensional figure according to any one of the above-described method for producing three-dimensional figure obtained by removing uncured molding powder composition; water adding step (step B2): for moisture added to the gypsum powder removing step has been removed on the three-dimensional shape of the powder; drying step (step B3): for drying the three-dimensional figure of water added in the water adding step. 下面说明各工序。 Each step will be described below.

[0131] 石膏粉末除去工序（步骤Bi)是指，从立体造型上除去未固化的造型用组合物的粉末。 [0131] gypsum powder removing step (step Bi) means to remove uncured shape from the three-dimensional shape of the powder composition. 该工序中，例如可通过喷枪朝立体造型喷气，吹掉未固化的石膏粉末。 In this step, for example, through the gun toward the three-dimensional shape of the jet, blow off uncured plaster powder. 风量或喷枪的形状等可通过公知技术适当调整。 Air volume or shape of the gun or the like can be adjusted by known techniques. 石膏粉末除去工序所需的时间也可适当调整，例如5分钟〜1小时，优选10分钟〜30分钟。 Gypsum powder removing step required time may be appropriately adjusted, for example, 5 minutes ~ 1 hour, preferably 10 minutes ~ 30 minutes.

[0132] 水分添加工序（步骤B》是指：将水分添加到所述石膏粉末除去工序中已除去粉末的立体造型上。该水分添加工序中，优选加入足够石膏进行水合反应的水分到立体造型上。该水分添加工序中，可以将立体造型浸渍在水或规定水溶液中。此时，由于粉末已经在前面的石膏粉末除去工序中除去，所以可防止与立体造型的外形无关的造型用组合物的粉末附着到立体造型上。 [0132] Water adding step (step B "means: adding water to the gypsum powder removing step, the removed powder three-dimensional modeling of the water adding step, preferably the hydration reaction of gypsum is added sufficient water to the three-dimensional figure on. The water adding step, three-dimensional modeling may be impregnated. At this time, since the powder has been removed in the step of removing water or an aqueous solution at a predetermined front gypsum powder, it can be prevented and the three-dimensional shape of the shape-forming composition independent The powder adheres to the three-dimensional shape.

[0133] 对于本发明的骨模型制造方法，其优选实施方式为，所述水分添加工序（步骤B2) 包括：喷雾工序（步骤B2-1)，通过朝所述石膏粉末除去工序中已除去粉末的立体造型上喷射雾状水分，或者，使立体造型暴露在高湿环境下，使水分附着在立体造型的表面上；浸渍工序（步骤B2-2)，在所述喷雾工序之后将立体造型浸渍在水中。 [0133] The method for producing a bone model of the present invention, a preferred embodiment thereof, the water adding step (step B2) comprises: spraying step (step B2-1), through the gypsum powder removing step towards the removal of the powder has spray a mist of water on the three-dimensional shape, or make three-dimensional modeling environment exposed to high humidity, the moisture attached to the surface of the three-dimensional modeling; impregnation step (step B2-2), after the three-dimensional shape of the spray dipping process in the water.

[0134] 当将获得的立体造型立即浸渍在水中时，立体图可能会出现变形（溃形）。 [0134] When the three-dimensional shape obtained immediately immersed in water, a perspective view may appear deformed (crushed shape). 因此， 鉴于该情况，本实施方式的骨模型制造方法经过了如下工序：首先，将水分添加在获得的立体造型表面（优选整个表面）上，从而通过石膏的水合反应加速至少表面上的固化反应(优选干燥），从而可防止立体造型变形，然后，将立体造型浸渍到水中，由此可充分加速固化反应。 Therefore, in view of this situation, the bone model producing method of the present embodiment through the following steps: First, the water added to the obtained three-dimensional shape of the surface (preferably the whole surface), to accelerate the curing reaction, at least on the surface by hydration reaction of gypsum (preferably dried) so as to prevent deformation of three-dimensional modeling, and then, the three-dimensional shape immersed in water, thereby sufficiently accelerate the curing reaction. 喷雾工序中，例如采用公知的喷雾将水或规定水溶液（优选水、交联剂水溶液或粘结剂水溶液）喷射到立体造型的表面上。 Spraying step, e.g., using a known spraying water or predetermined aqueous solution (preferably water, cross-linker solution, or binder aqueous solution) was sprayed onto the surface of the three-dimensional shape. 或者使立体造型暴露在高湿环境下，这样将水等附着到立体造型的表面上。 Or make three-dimensional modeling of exposure in a high humidity environment, which will be attached to the surface of the water and other three-dimensional modeling. 本发明中，也可在喷射水分之后对立体造型进行干燥，然后将其浸渍到水中。 The present invention may also be in the water after the injection of three-dimensional modeling and dried, and then immersed in water. 干燥可在低温高湿的环境（例如，湿度0%〜10%，温度50°C〜2X102°C ) 下进行，也可在常温常压的环境下进行。 Dried at low temperatures and high humidity environment (eg, humidity of 0% ~ 10%, temperature 50 ° C~2X102 ° C) carried out, can be carried out at ambient temperature and pressure conditions. 常温常压下的干燥时间可根据获得的立体造型的大小、水分含量、各层的厚度等适当调整，如1 X 10分钟〜2小时、15分钟〜1小时或2 X 10 分钟〜4X10分钟。 Drying time under normal temperature and pressure can be adjusted to obtain the size of the three-dimensional shape, moisture content, etc. according to the thickness of each layer, such as 1 X 10 分钟 ~ 2 hours, 15 minutes ~ 1 hour, or 2 X 10 分钟 ~4X10 minutes. 浸渍工序中，将立体造型浸渍在充足的水或水溶液中。 Impregnation step, the three-dimensional shape is immersed in plenty of water or an aqueous solution. 浸渍时间也可根据立体造型的大小适当调整，如1X10分钟〜2小时、15分钟〜1小时或2X10分钟〜 4X10分钟。 Impregnation time can be adjusted according to the size of the three-dimensional shape, such as 1X10 minutes ~ 2 hours, 15 minutes ~ 1 hour ~ 4X10 minutes or 2X10 minutes.

[0135] 对于上述骨模型的制造方法，其优选实施方式为，所述水分添加工序（步骤B2)包括（1)〜（3)中任意一种工序。 [0135] The method for producing the above-described bone model which is a preferred embodiment, the water adding step (step B2) comprises (1) to (3) in any one step. （1)喷雾工序和浸渍工序。 (1) spraying process and impregnating step. 所述喷雾工序是指，在所述石膏粉末除去工序中已除去粉末的立体造型上喷射雾状水分，或者使立体造型暴露在高湿环境下，由此将水分附着到立体造型的表面上；所述浸渍工序是指，在所述喷雾工序之后，将立体造型浸渍在交联剂水溶液中；（¾喷雾工序和浸渍工序。所述喷雾工序是指，在所述石膏粉末除去工序中已除去粉末的立体造型上喷射雾状交联剂水溶液，或者使立体造型暴露在交联剂水溶液的高湿环境下，由此将交联剂水溶液附着到立体造型的表面上；所述浸渍工序是指，在所述喷雾工序之后，将立体造型浸渍在交联剂水溶液中；C3)喷雾工序和浸渍工序。 Refers to the step of spray, mist spray water on the gypsum powder removing step, three-dimensional shape of the powder has been removed, so that three-dimensional figure or exposed to high humidity environment, whereby the moisture adhered to the surface of the three-dimensional shape; refers to the impregnation step, after the step of spraying, immersing the three-dimensional figure in cross-linker solution;. (¾ spraying step and the step of impregnating step is a spray means, the gypsum powder removing step has been removed the three-dimensional shape of the powder spray mist cross-linker solution, or make three-dimensional figure in cross-linker solution exposed to high humidity environment, whereby the cross-linker solution adhered to the surface of the three-dimensional shape; said impregnation step is a after said step of spraying, immersing the three-dimensional figure in cross-linker solution; C3) spraying step and the dipping step. 所述喷雾工序是指，在所述石膏粉末除去工序中已除去粉末的立体造型上喷射雾状水分，或者使立体造型暴露在高湿环境下，由此将水分附着到立体造型的表面上；所述浸渍工序是指，在所述喷雾工序之后，将立体造型浸渍在水中，再将立体造型浸渍在交联剂水溶液中。 Refers to the step of spray, mist spray water on the gypsum powder removing step, three-dimensional shape of the powder has been removed, so that three-dimensional figure or exposed to high humidity environment, whereby the moisture adhered to the surface of the three-dimensional shape; It refers to the impregnation step, after the step of spraying, immersing the three-dimensional figure in water, and then immersed in a three-dimensional figure in cross-linker solution. 其中，当采用具有乙酰乙酰基的变性聚乙烯醇树脂时，优选工序（1)或工序C3)。 Wherein, when a modified polyvinyl alcohol resin having an acetoacetyl group, preferably step (1) or step C3). 其原因在于，从立体造型的硬度或骨模型的均一性来看，优选在利用水促进形成螯合结构之后用交联剂促进交联反应。 The reason is that, from the perspective uniformity of the hardness or shape of a bone model, it is preferable in the promotion of the use of water after forming a chelate structure with a crosslinking agent to promote crosslinking reaction.

[0136] 由此，通过添加交联剂水溶液等交联剂，可促进立体造型中的交联反应，并可获得具有足够硬度的骨模型。 [0136] Thus, the cross-linker solution by adding a crosslinking agent, etc., can promote the crosslinking reaction of three-dimensional modeling, and has sufficient hardness can be obtained bone model. 此外，也可按上述方式来实施喷雾工序和浸渍工序。 In addition, in accordance with the process described above to implement spraying and dipping processes. 交联剂水溶液的浓度可根据所采用的聚乙烯醇树脂的种类或想获得的固化物的硬度等而适当调整。 The concentration of the aqueous solution of the crosslinking agent may be employed according to the kind of polyvinyl alcohol resin or the like to the hardness of the cured product obtained and appropriately adjusted. 具体而言，交联剂水溶液的浓度可以为1 X 10_2容积％〜2 X 10容积％，优选为1 X KT1容积％〜 1.5\10容积％。 Specifically, the concentration of the aqueous solution of the crosslinking agent may be 1 X 10_2 volume% ~2 X 10 volume%, preferably 1 X KT1 vol% to 1.5 \ 10 vol%. 作为交联剂，可代替乙二胺或二乙醇胺等胺类交联剂，或者与它们一起适当使用如下物质：甲醛或乙二醛等的醛类化合物；三聚氰胺-甲醛缩合物或尿素-甲醛缩合物等羟甲基类化合物；硼酸或硼砂等含硼化合物；2，4甲苯二异氰酸酯、2，6甲苯二异氰酸酯、间-亚苯基二异氰酸酯、对-亚苯基二异氰酸酯或4，4'- 二苯基甲烷二异氰酸酯等异氰酸酯类化合物；或硅烷偶联剂等。 As the crosslinking agent, can replace ethylenediamine or diethanolamine amine cross-linking agent, or in conjunction with their appropriate use of the following materials: formaldehyde, glyoxal or aldehyde compounds; melamine - formaldehyde condensate or urea - formaldehyde condensation etc. hydroxymethyl compounds; boric acid or borax and other boron-containing compound; 2,4-toluene diisocyanate, 2,6-toluene diisocyanate, m - phenylene diisocyanate, for - phenylene diisocyanate or 4,4 ' - diphenyl methane diisocyanate, etc. isocyanate compound; or a silane coupling agent. 其中，交联剂优选采用乙二胺或二乙醇胺等的胺类交联剂，具体原因可通过后述实施例予以证明，交联剂更优选采用乙二胺、二乙醇胺或该二者。 Wherein the crosslinking agent is preferably used such as ethylenediamine or diethanolamine amine crosslinking agent after the specific reasons can be proved by the above embodiment, the crosslinking agent is more preferably used ethylenediamine, diethanolamine, or the both.

[0137] 干燥工序是使在所述水分添加工序中添加有水分的立体造型干燥的工序（步骤B3)。 [0137] drying step is added with water to make three-dimensional shape of the drying step (step B3) in the water adding step. 干燥可在低温高湿的环境（例如，湿度0%〜10%，温度50°C〜2X102°C )下进行， 也可在常温常压的环境下进行。 Dried at low temperatures and high humidity environment (eg, humidity of 0% ~ 10%, temperature 50 ° C~2X102 ° C) carried out, can be carried out at ambient temperature and pressure conditions. 常温常压下的干燥时间可根据立体造型的大小、水分含量、 各层的厚度等适当调整，如1小时〜4天、4小时〜3天或6小时〜两天。 Drying time under normal temperature and pressure can be adjusted three-dimensional shape of the size, moisture content, etc. according to the thickness of each layer, such as one hour ~ 4 days, 4 hours ~ 6 hours ~ 3 days or two days.

[0138] 本发明优选比较迅速地制造骨模型，所以干燥时间优选为1小时〜4小时。 [0138] The present invention is preferably relatively rapid bone model produced, so the drying time is preferably 1 hour ~ 4 hour.

23[0139] 3-2.造型材料填充工序（步骤2) 23 [0139] 3-2. Forming material filling step (Step 2)

[0140] 造型材料填充工序是对在所述骨模型制造工序中获得的骨模型的骨缺损部分填充造型材料的工序。 [0140] forming material filling step of filling bone defects on the part of the bone model obtained in the bone model producing step in a step-forming material. 通过填充造型材料，可获得骨填充材造型。 By filling molding material obtained bone filler modeling.

[0141] 对于造型材料并没有特别限定，只要能获得骨填充材造型即可，例如可采用公知的造型材料。 [0141] For molding material is not particularly limited as long as the shape of a bone filler can be obtained, for example, and a known molding materials. 但造型材料优选是为能与骨模型相区别的材料。 But modeling material is preferably a distinguished model with bone material. 具体而言，优选X射线透过率、红外线透过率或紫外线透过率与所述骨模型不同的造型材料；例如，当造型材料固化成填充材造型时，其χ射线透过率、红外线透过率或紫外线透过率可分别为骨模型的X射线透过率、红外线透过率或紫外线透过率的90%以下或110%以上。 Specifically, preferably X-ray permeability, the infrared transmittance or ultraviolet transmittance models with different shapes of the bone material; for example, when the molding material solidifies into a filler shape, its χ-ray permeability, the infrared transmittance or ultraviolet transmittance of X-ray transmission respectively bone model, more infrared transmittance UV transmittance of 90% or less, or 110%. 若造型材料具有这样的X射线透过率、红外线透过率或紫外线透过率，则能容易地将填充有造型材料的骨填充材造型与骨模型区分开。 If the molding material having an X-ray permeability, the infrared transmittance or ultraviolet transmittance is able to be easily filled with the molding material bone filler and bone model modeling distinguished. 这种造型材料可以是与骨模型的原料相同，并具有着色剂、金属粉末或金属氧化物粉末等的材料。 This molding material may be the same raw material and the bone model, and having a colorant, a material of the metal powder or metal oxide powder or the like.

[0142] 造型材料例如可以以蜡成分（例如，牙科用蜡）作为主要成分。 [0142] forming material may be e.g. a wax component (e.g., dental wax) as a main component. 蜡不仅可以是固体石腊，还可以是蜂蜡、微晶蜡、达马树脂、松香、小烛树蜡、巴西棕榈蜡、褐煤蜡之一或它们的混合物，其中，优选以固体石腊作为主要成分。 May be not only solid paraffin wax, it may also be beeswax, microcrystalline wax, dammar, rosin, candelilla wax, carnauba wax, montan wax, one or a mixture thereof, wherein the solid paraffin is preferably used as the main ingredients. 以固体石腊作为主要成分的造型材料可以是：通过蜂蜡或微晶蜡来增加柔软性和粘合性的造型材料；添加有达马树脂或松香来改善硬度和强度同时增加粘合性的造型材料；添加有高熔点的巴西棕榈蜡来增强蜡的表面光泽度的造型材料。 Solid paraffin as the main component molding material can be: through beeswax or microcrystalline wax to increase the flexibility and adhesion of molding material; added Dama resin or rosin to improve the hardness and strength while increasing adhesion shape material; added with a high melting point wax, carnauba wax to enhance the surface gloss of the molding material. 作为烃类树脂和乙烯-醋酸乙烯共聚物树脂混合后的合成树脂，优选在固体石蜡中加入1〜5重量％的乙烯-醋酸乙烯共聚物树脂。 A hydrocarbon resin and an ethylene - vinyl acetate copolymer resin, synthetic resin mixed, preferably 1 ~ 5 wt% is added in the solid paraffin ethylene - vinyl acetate copolymer resin. 牙科用蜡可以是固体石腊、条形滚蜡（口一1J >夕'υ V >7 % )、铸造用条形蜡(7。口，η、”入)、牙床边缘形成用条形蜡、Ky υ、”、、、万能齿科蜡（口-一歹^ ·」歹^ 一7夕夕ζ )、蜡提（κ ^卜〗J α ζ歹^ ν夕）或雕刻蜡、m ”” m通过凝胶渗透色谱（GPC)测定的蜡的数量平均分子量（Mn)可以为400〜5000，优选为800〜5000，更优选为1000〜 3000，还优选为1500〜2500。 Dental paraffin wax may be a solid, wax roll bar (port one 1J> Xi 'υ V> 7%), the strip casting wax (7. mouth, η, "in), gum is formed by the edge of the strip of wax , Ky υ, ",,, universal dental wax (I - a bad ^ *" ^ bad a 7 Xixi ζ), wax mention (κ ^ BU〗 J α ζ ^ ν bad evening) or carved wax, m " "m by gel permeation chromatography (GPC) measurement of number average molecular weight of the wax (Mn) may be 400~5000, preferably 800~5000, more preferably 1000~ 3000, further preferably 1500~2500. 通过GPC测定的蜡的重量平均分子量与数量平均分子量之比(Mw/Mn)可以为4. 0以下，优选为3. 5以下，更优选为3. 0以下。 Determined by GPC weight average molecular weight of the wax and the number average molecular weight ratio (Mw / Mn) may be 4.0 or less, preferably 3.5 or less, more preferably 3.0 or less. 重量平均分子量（Mw)和数量平均分子量（Mn)是通过凝胶渗透色谱（GPC)测得的聚苯乙烯换算值。 Average weight (Mw) of, and the number average molecular weight (Mn) is measured by gel permeation chromatography (GPC) in terms of polystyrene measured. 本实施方式中的GPC测定是在温度为140°C、溶剂为邻二氯苯的条件下进行的。 The embodiment of GPC measurement at a temperature of 140 ° C, the solvent is ortho-dichlorobenzene conditions.

[0143] 蜡的颜色可以是牙科常用的红色，除此之外，也可以是白色、黄色或黑色等。 [0143] The color may be a dental wax commonly red, in addition, it can be white, yellow or black. 白色蜡是通过将白色颜料氧化钛混合在固体石蜡等蜡中制成。 White wax by mixing white pigment titanium dioxide formed in the solid paraffin wax. 黄色蜡例如是通过将黄色颜料钛黄混合在固体石蜡等蜡中制成，钛黄是氧化钛的一种。 Yellow wax, for example, by mixing the yellow pigment titanium yellow solid paraffin wax made of titanium yellow is a titanium oxide. 黑色蜡例如是通过将黑色颜料苯胺黑混合在固体石蜡等蜡中制成。 Black wax, for example, by mixing a black pigment nigrosine made in solid paraffin wax.

[0144] 造型材料优选含有无机粉末、有机粉末、高级脂肪酸的金属盐粉末、颜料、着色剂、 金属粉末、金属氧化物粉末等，从而可使固定有造型材料的骨填充材造型能在X射线透过率、红外线透过率或紫外线透过率方面与骨模型区分开。 [0144] forming material preferably contains an inorganic powder, organic powder, metal salt powder of a higher fatty acid, pigments, colorants, metal powder, metal oxide powder, thereby allowing the shape is fixed bone filler material can be in the shape of an X-ray transmittance, infrared transmittance or ultraviolet transmittance aspects distinguish bone model.

[0145] 无机粉末可以是氧化钛、氧化锆、氧化锌、氧化铈、氧化镁、硫酸钡、硫酸钙、硫酸镁、碳酸钙、碳酸镁、滑石、云母、高岭土、绢云母、白云母、合成云母、金云母、红云母、黑云母、锂云母、硅酸、无水硅酸、硅酸铝、硅酸镁、硅酸镁铝、硅酸钙、硅酸钡、硅酸锶、钨酸金属盐、羟磷灰石、蛭石、氢氧化铝制品（商品名：〃彳^，彳卜）、斑脱土、蒙脱土、锂蒙脱石、沸石、陶瓷粉末、二代磷酸钙、氧化铝、氢氧化铝、氮化硼、硅石等。 [0145] Inorganic powder may be titanium oxide, zirconium oxide, zinc oxide, cerium oxide, magnesium oxide, barium sulfate, calcium sulfate, magnesium sulfate, calcium carbonate, magnesium carbonate, talc, mica, kaolin, sericite, muscovite, synthetic mica, gold mica, red mica, biotite, lepidolite, silicic acid, anhydrous silicic acid, aluminum silicate, magnesium silicate, magnesium aluminum silicate, calcium silicate, barium, strontium, metal tungstate salt, hydroxyapatite, vermiculite, aluminum hydroxide product (trade name: ^ 〃 left foot, left foot BU), bentonite, montmorillonite, hectorite, zeolite, ceramics powder, calcium secondary phosphate, oxidation aluminum, aluminum hydroxide, boron nitride, silica and the like.

[0146] 有机粉末可以是聚酰胺粉末、聚酯粉末、聚乙烯粉末、聚丙烯粉末、聚苯乙烯粉末、聚氨酯、苯代三聚氰胺粉末、聚甲基苯代三聚氰胺粉末、四氟乙烯粉末、聚甲基丙烯酸甲酯粉末、纤维素、丝粉、尼龙粉、尼龙12、尼龙6、具有二甲基硅酮交联结构的交联硅细粉、聚甲基倍半硅氧烷的细粉、苯乙烯-丙烯酸共聚物、二乙烯基苯-苯乙烯共聚物、乙烯树脂、脲醛树脂、酚树脂、氟树脂、硅酮树脂、丙烯酸树脂、三聚氰胺甲醛树脂、环氧树脂、聚碳树脂、微晶纤维素粉末、淀粉粉末、月桂酰赖氨酸等。 [0146] The organic powder may be polyamide powder, polyester powder, polyethylene powder, polypropylene powder, polystyrene powder, polyurethane, benzoguanamine powder, polymethyl benzoguanamine powder, tetrafluoroethylene powder, poly methyl methacrylate powder, cellulose, silk powder, nylon powder, nylon 12, nylon 6, having a dimethyl silicone crosslinked structure crosslinked silicone fine powder, polymethyl silsesquioxane powder, benzene ethylene - acrylic acid copolymer, divinylbenzene - styrene copolymer, an ethylene resin, urea resin, phenol resin, fluorine resin, silicone resin, acrylic resin, melamine formaldehyde resin, epoxy resin, polycarbonate resin, microcrystalline fiber pigment powder, starch powder, lauroyl lysine and the like. 此外，也可采用大部分由-[Si-0-]n-结构构成的有机粉末。 In addition, most can also be used by the - [Si-0-] n- structure composed of the organic powder. 此时，分子的一部分可具有-Si (CH2CH2)m-Si-结构。 At this time, part of the molecule may have a -Si (CH2CH2) m-Si- structure.

[0147] 高级脂肪酸的金属盐粉末（金属皂）可以是硬脂酸锌、硬脂酸铝、硬脂酸钙、硬脂酸镁、豆蔻酸锌、豆蔻酸镁、鲸蜡醇磷酸酯锌、鲸蜡醇磷酸酯钙、鲸蜡醇磷酸锌钠。 [0147] powder of a higher fatty acid metal salt (metallic soap) can be zinc stearate, aluminum stearate, calcium stearate, magnesium stearate, zinc myristate, magnesium myristate, zinc cetyl phosphate, cetyl phosphate, calcium, zinc, sodium cetyl alcohol.

[0148] 有色颜料可以是氧化铁、氢氧化铁、钛酸铁的无机红色颜料；Y -氧化铁等无机褐色颜料；黄氧化铁、黄土等无机黄色颜料；黑氧化铁、炭黑等的无机黑色颜料；锰紫、钴紫等无机紫色颜料；氢氧化铬、氧化铬、氧化钴、钛酸钴等无机绿色颜料；铁蓝、群青等无机蓝色颜料；浙青类色淀颜料；天然色淀颜料以及其复合在一起的合成树脂粉末等。 [0148] color pigment can be iron oxide, iron hydroxide, iron titanate, inorganic red pigment; Y - iron oxide, inorganic brown pigments; yellow iron oxide, loess, inorganic yellow pigments; black iron oxide, carbon black and other inorganic black pigments; manganese violet, cobalt violet and organic violet pigment; chromium hydroxide, chromium oxide, cobalt oxide, cobalt titanate, inorganic green pigment; iron blue, ultramarine blue inorganic pigment; Zhejiang green type lake pigments; natural color lake pigment and synthetic resin powder complexes together its like.

[0149] 珠光颜料可以是具有氧化钛涂层的云母、氯氧化铋、具有氧化钛涂层的氯氧化铋、 具有氧化钛涂层的滑石、鱼鳞箔（fish scalegimnine)、具有氧化钛涂层的彩色云母等。 [0149] Pearlescent pigments may be mica coated with titanium oxide, bismuth oxychloride, titanium oxide coated with bismuth oxychloride, talc coated with titanium oxide, fish scale foil (fish scalegimnine), coated with titanium oxide color mica.

[0150] 金属粉末颜料可以是铝粉末、铜粉末、不锈钢粉末等。 [0150] the metal powder pigment may be aluminum powder, copper powder, stainless steel powder and the like.

[0151] 天然色素可以是选自胭脂红酸、紫胶色酸、红花素、巴西木素、藏红花素等的粉末。 [0151] natural pigment can be powder acid, shellac color acid, safflower, brazilwood factors, factors such as saffron is selected from carmine. 在不影响本发明效果的范围内，这些粉末可以是粉末的组合，也可以是用普通的油、硅油、 氟化合物或表面活性剂等处理过的粉末，例如，可以是具有反应性的含氢聚硅氧烷；具有水解烷氧基硅烷基团的有机聚硅氧烷；具有水解甲硅烷基的丙烯硅类共聚物；根据需要，也可采用其中一种或二种以上的组合物。 In the effect of the present invention does not affect the scope of these powders can be a combination of a powder, may be ordinary oils, silicone oil, fluorine compound, or surfactant treated powder, for example, it may be a reactive hydrogen polysiloxanes; hydrolyzable alkoxysilane groups organopolysiloxane; propylene-based copolymer having silicon-hydrolyzable silyl group; if necessary, may also be used in which one or two or more kinds of compositions. 具体情况下，色素可以是所述的氧化钛等。 Under the circumstances, the pigment may be titanium oxide and the like. 金属粉末或金属氧化物粉末也没有特别限定，可根据情况采用公知的物质。 Metal powder or metal oxide powder is not particularly limited, and known materials can be adopted according to the situation. 金属粉末或金属氧化物粉末优选氧化钛，更优选锐钛型或金红石型氧化钛。 Metal powder or metal oxide powder is preferably titanium, more preferably anatase or rutile type titanium oxide. 金属粉末或金属氧化物粉末的粒度(根据JISR1619分析的粒度）可以是IXlO2nm以上且5 XlO3Iim以下，优选为5 XlO2Iim以上且3X103nm以下。 Metal powder or metal oxide powder particle size (according to JISR1619 size analysis) can be 5 XlO3Iim IXlO2nm more and less, and more preferably 5 XlO2Iim 3X103nm less. 如后面实施例所述，造型材料可以是含有总重量的90%以上（优选为95%以上）的蜡，并含有总重量的2%以上5 %以下的金属粉末或金属氧化物粉末，优选含有总重量的3%以上4%以下的金属粉末或金属氧化物粉末。 As described later in Example, a molding material may contain more than 90% of the total weight of (preferably 95% or more) of the wax, and more than 2% of the total weight of 5% or less of metal powder or metal oxide powder comprising, preferably The total weight of more than 3% to 4% of a metal powder or metal oxide powder.

[0152] 由于骨模型是根据RP法等制成的反映患者骨状态的模型，所以医生等可将造型材料填充在该骨模型的骨缺损部分上。 [0152] As the bone model is made based on the model RP method reflects the state of the patient bone, so doctors may be molding material is filled in the bone defect portion of the bone model. 这样，由于是外科医生自己直接在精确的骨模型上形成填充材造型，所以可获得外科医生用起来比较趁手的骨填充材。 Thus, since the surgeon himself filler is formed directly on the precise shape of a bone model, so as to attain the surgeon using up more conveniently bone filler. 由于造型材料的主要成分是如固体石蜡等，所以可通过热水等来增强造型材料的柔软性，因此优选在该状态下装入可填充骨缺损部分的造型材料。 As the main component molding material is solid paraffin and the like, it is possible to enhance the softness of modeling materials such as hot water, it is preferable to be filled into the bone defect portion molding material in this state. 此外，在对骨模型的骨缺陷部分填充造型材料时，造型材料可被自动填充在骨模型的骨缺陷部分上。 In addition, when the bone defect model of bone-forming material partially filled, molding material can be automatically filled in bone defect model part.

[0153] 由于填充在骨模型的骨缺陷部分上的造型材料是以例如固体石蜡作为主要成分， 所以可通过静置使其固化，变成骨填充材造型。 [0153] Since the filling on the bone defect model is part of the molding material such as paraffin wax as a main ingredient, it can be cured by standing, into the shape of a bone filler. 该骨填充材造型是用于对患者进行治疗等的骨填充材，并与骨缺损部分在形状上的高精确度一致。 The shape of a bone filler is used for treatment of patients with bone filler and bone defect is consistent with some of the high accuracy in shape.

[0154] 3-3.骨填充材制造工序（步骤3) [0154] 3-3. Bone filler producing step (step 3)

[0155] 骨填充材制造工序是指，根据造型材料填充工序中填充在骨模型的骨缺损部分上的造型材料（或骨填充材造型），制造用于填充骨缺损部分的骨填充材。 [0155] bone filler producing step is a step in the bone defect site of the bone model modeling material (or bone filler molding) molding material filling step of filling according manufactured for bone filler filling bone defect portion. 造型材料填充工序中，造型材料是填充在骨模型的骨缺损部分上。 Forming material filling step, the molding material is filled in the bone defect site of the bone model. 造型材料固化成的骨填充材造型在某些方面能与骨模型相区别。 Curing the molding material into the shape of a bone filler and bone in some respects can be distinguished from the model. 因此，优选采用这种骨填充材造型等来制造骨填充材。 Thus, this is preferable to use a bone filler such as modeling bone filler produced. 此外，可根据获得的骨填充材造型的形状制造模具，再通过粉末注射成型法或对其修改后的方法来制造骨填充材。 In addition, according to the shape of the obtained bone filler shape manufacturing mold, and then by the powder injection molding method or its modified method of producing bone filler.

[0156] 具体而言，可按照如下方式来制造骨填充材：S卩，由于骨填充材造型与骨模型具有不同的X射线透过率或反射率，所以可通过X射线CT对各包含有骨填充材造型的骨模型进行摄影，然后将获得的X射线透过率或反射率发送到PC等控制装置，控制装置根据X射线透过率或反射率的差异来确定骨填充材造型的形状，并将骨填充材的形状信息发送给骨填充材制造装置，骨填充材制造装置根据所述形状信息输出用于制造骨填充材的指令。 [0156] Specifically, in the following manner to produce a bone filler: S Jie, due to the shape of a bone filler and bone model with different X-ray transmission or reflectance, it is possible by X-ray CT for each contains bone filler the bone model modeling photography and X-ray transmission or reflectance transmittance obtained to the PC and other control means, the control means based on the difference X-ray transmittance or reflectance to determine the shape of the shape of a bone filler , the shape information and sent to the bone filler producing a bone filler device, instruction producing a bone filler producing a bone filler according to the shape of the means for information output. 该制造装置例如是基于RP法的骨填充材的制造装置，骨填充材可以按照RP法或前述方法来制造。 The manufacturing apparatus manufacturing apparatus, for example, based on the RP method bone filler, bone filler can be produced in accordance with the aforementioned method or a method of RP. 在按照RP法来制造骨填充材的情况下，原料粉末可采用以下说明的磷酸钙类物质等化合物粉末。 In the case in accordance with the RP method of manufacturing a bone filler, calcium phosphate-based compound powder and other raw material powder can be used as described below.

[0157] 下面，按照粉末注塑成型法来说明骨填充材的制造方法。 [0157] Next, the powder injection molding method according to the method of manufacturing a bone filler. 骨填充材的制造方法大致具有如下工序。 Method for producing a bone filler having substantially the following steps. 混炼工序：对具有钙类物质的原材料和具有粘结剂的材料进行混炼的工序；成型工序：采用具有模具的注塑成型机，通过注塑成型法将在所述混炼工序中获得的混炼物形成具有规定形状的成型体；粘结剂去除（脱脂）工序：用于去除所述成型工序中获得的成型体所含的粘结剂，获得脱脂体；烧结工序：对所述粘结剂去除工序中获得的脱脂体加热并烧结，获得烧结体。 Kneading step: raw materials have calcium-based material and a material having a binder kneading step; forming step: a mold using an injection molding machine, mixing by injection molding obtained in the kneading step refining was formed to have a predetermined molded shape; binder removal (degreasing) step: step for forming an adhesive removing said molded body obtained contained, obtained degreased body; sintering step: the bonding of the removing agents degreased body obtained in step is heated and sintered to obtain a sintered body. 此外，该方法也可包括对成型体进行后处理的后处理工序等公知工序。 In addition, the method may also include a known post-treatment step after the step of molding processing.

[0158] 由于按照骨填充材的制造方法获得的各骨填充材大小均勻，所以即使骨填充材中含有药剂时，也可加入适量的药剂。 [0158] As a result of a bone filler according to the method of manufacturing a bone filling material obtained in uniform size, so that even when the bone filling material containing the agent, the agent can be added to an appropriate amount. 此外，由于骨填充材的密度均勻且大小可控，所以在加入多个骨填充材的情况下，可在维持各骨填充材的强度的情况下获得适当的空隙率。 Further, since the density of bone filler uniform and controlled size, it is added in the case of a plurality of bone filling material, can obtain appropriate porosity while maintaining the strength of each bone filling material. 下面， 对骨填充材的制造方法的各工序进行说明。 Next, for each method of manufacturing a bone filling material will be described.

[0159] 混炼工序：对含有钙类物质的原材料和具有粘结剂的材料进行混炼的工序。 [0159] kneading process: raw materials containing calcium-based material and a material having a binder kneading step. 该工序中，优选采用粉末状原料。 In this step, preferably using powdered material. 混炼工序中，混合原料粉末和粘结剂等辅助材料，使他们形成适于注塑成型的形状。 Kneading step, the mixed raw material powder and a binder and other auxiliary materials, so that they form a shape suitable for injection molding.

[0160] 粉末状原料可以是钙类物质。 [0160] powdered material may be calcium-based material. 所述钙类物质可以是磷酸钙类物质、碳酸钙类物质、 乳酸钙以及葡萄糖酸钙，其中，优选磷酸钙类物质或碳酸钙类物质。 The calcium-based material may be a calcium phosphate-based substances, substances calcium carbonate, calcium lactate and calcium gluconate, wherein, preferably calcium phosphate or calcium carbonate substances substances. 具体而言，原料粉末即磷酸钙类物质可以是如下物质中任意一种或任意两种以上，即，羟基磷灰石、碳酸磷灰石、 氟磷灰石、氯磷灰石、β-TCP、α-TCP、偏磷酸钙、磷酸四钙、磷酸氢钙、磷酸二氢钙、焦磷酸钙、磷酸八钙、它们的盐或溶剂和二水合物。 Specifically, the calcium phosphate-based material that is the raw material powder may be any one of the following materials or any two or more, i.e., hydroxyapatite, carbonate apatite, fluorapatite, chlorapatite, β-TCP , α-TCP, calcium metaphosphate, tetracalcium phosphate, calcium hydrogen phosphate, calcium dihydrogen phosphate, calcium pyrophosphate, octacalcium phosphate, a salt or solvate thereof and dihydrate. 其中，优选β-TCP或羟基磷灰石。 Among them, β-TCP or hydroxy apatite. 碳酸钙类物质可以是碳酸钙和碳酸氢钙，其中，优选碳酸钙。 Calcium carbonate species may be calcium carbonate, calcium bicarbonate and wherein, preferably calcium carbonate. 本实施方式中，原料粉末不限于上述物质， 可根据情况采用作为骨填充材原料使用的公知物质。 In this embodiment, the raw material powder is not limited to the above-described materials, a known substance can be used as a bone filler material used according to the situation.

[0161] 若原料粉末太小，则需要很多粘结剂，从而会破坏获得的骨填充材的物理特性。 [0161] If the raw material powder is too small, you need a lot of adhesive, which will destroy the physical properties of the resultant bone filling material. 若原料粉末太大，则有可能进入成型机的螺杆和料筒之间的间隙内而卡住，或者可能不能顺利进行烧结。 If the raw material powder is too large, it is possible to enter the gap of the molding machine screw and barrel and stuck between, or may not be successfully sintered. 本发明中，基本上是采用粉末注塑成型，但粉末注塑成型中所使用的原料粉末并非总是是金属粉末。 In the present invention, basically by powder injection molding, but the raw material powder used in the powder injection molding is not always metal powder. 根据实验结果，原料粉末的大小例如可以为0. 01 μ m〜100 μ m(即， Ο.ΟΙμπι以上，IOOym以下。下面对范围的限定方式也与此相同）。 According to the experimental results, the size of the raw material powder may for example be 0. 01 μ m~100 μ m (i.e., Ο.ΟΙμπι above, IOOym or less. Next, define the scope of the ways and the same). 优选为O.lym〜 20 μ m0在粉末冶金学中，例如采用大小约为ΙΟΟμπι的粉末。 O.lym~ 20 μ m0 preferably in powder metallurgy, for example, using a size of about ΙΟΟμπι powder. 如日本发明专利公开公报特开2004-97259号（所述专利文献1)中所记载，采用粒度为150 μ m以下的羟基磷灰石（该公报的【0025】段)。 As described in Japanese Unexamined Patent Publication No. 2004-97259 (Patent Document 1), it may be used a particle size of 150 μ m or less of hydroxyapatite (the publication of the [0025] section). 但本发明优选采用粒度较小的粉末，以提高由原料粉末和粘结剂混炼而成的混炼物的流动性，并提高烧结后的密度。 However, the present invention preferably uses a smaller particle size of the powder in order to improve kneading the raw material powder and a binder formed from the kneaded material flow, and increase the density after sintering. 此外，虽然本发明所制造的骨填充材要求一定程度的强度，但当其填充在生物体内时，是假定被破骨细胞等侵蚀。 Further, although the present invention is produced bone filler requires a certain degree of strength, but at the time of filling vivo, is assumed by osteoclasts and other erosion. 从这一点上来，粉末的大小可以是0. Iym〜50μΐΉ，优选0. 5μπι〜10 μ m。 From this point up, the size of the powder can be 0. Iym~50μΐΉ, preferably 0. 5μπι~10 μ m.

[0162] 混炼工序中，将粘结剂等除原材料以外的材料（一种或多种化合物)混合在原材料中。 [0162] kneading step, adhesive and other materials (one or more compounds) in addition to the raw materials were mixed in the raw material. 该粘结剂可以是（甲基）丙烯酸类树脂、蜡润滑剂、（优选除（甲基）丙烯酸类树脂以外的热塑性树脂）、以及具有润滑剂的物质。 The binder may be a (meth) acrylic resin, wax lubricant, (preferably in addition to (meth) acrylic resin, a thermoplastic resin), and having a lubricant material. 甲基丙烯酸类树脂或丙烯酸类树脂可以是甲基丙烯酸树脂或丙烯酸树脂。 Methacrylic resin or an acrylic resin may be a methacrylic resin or an acrylic resin. 具体而言，可以是甲基丙烯酸正丁酯聚合物、甲基丙烯酸甲酯聚合物或甲基丙烯酸正丁酯和甲基丙烯酸甲酯的共聚物。 Specifically, a n-butyl methacrylate polymers, methyl methacrylate polymers or n-butyl methacrylate and methyl methacrylate. 甲基丙烯酸类树脂或丙烯酸类树脂的分子量没有特别限定，但优选对其适当调整，以便不破坏获得的骨填充材的物理特性， 例如，其重量平均分子量可以是IXlO3〜1X105。 Molecular weight methacrylic resin or an acrylic resin is not particularly limited, but it is preferably appropriately adjusted, so as not to destroy the physical properties of the resultant bone filling material, for example, the weight average molecular weight may be IXlO3~1X105. 粘结剂中的甲基丙烯酸类树脂或丙烯酸类树脂的含量没有特别限定，但优选对其适当调整，以便不破坏获得的骨填充材的物理特性，如1重量％〜50重量％。 The content of the binder methacrylic resin or an acrylic resin is not particularly limited, but it is preferably appropriately adjusted so as not to destroy the bone filling material obtained by the physical characteristics, such as 1 wt% ~ 50 wt%.

[0163] 蜡润滑剂的熔点可以是40°C〜100°C，优选为40°C〜70°C。 [0163] The melting point of wax lubricant can be 40 ° C~100 ° C, preferably 40 ° C~70 ° C. 这种熔点的蜡例如可以是公知的固体石蜡。 The melting point of the wax may be known, for example paraffin wax. 通过采用这种熔点的蜡，在注塑成型时成型体能容易地从模具脱开。 By using this melting wax, molded in injection molding Physical easily detached from the mold. 本发明中，更优选采用熔点为60°C〜65°C的蜡润滑剂，此时，即使不长时间地冷却模具，也可将成型体从模具中取出。 In the present invention, more preferably a melting point of using 60 ° C~65 ° C wax lubricant, at this time, a long time without cooling the mold, the molded body can also be removed from the mold.

[0164] 蜡润滑剂可以是如下物质中的一种或两种以上。 [0164] The lubricant may be a wax material as one or two or more kinds. 即，液态石蜡、鲨烯、角鲨烷等烃油；油酸、妥尔油、异硬脂酸等高脂肪酸；月桂醇、油醇、异硬脂醇、辛基月桂醇等高级醇； 甲基聚硅氧烷、苯甲基聚硅氧烷、甲基氢聚硅氧烷、十甲基聚硅氧烷等硅油；肉豆蔻酸异丙酯、棕榈酸异丙酯、月桂酸己酯、油酸油酯、油酸癸酯、辛基十二醇肉豆蔻酸酯、二甲基辛酸十六烷基酯、邻苯二甲酸二乙酯、邻苯二甲酸二丁酯等酯；鳄梨油、山茶油，海龟油，澳大利亚坚果油，玉米油，香油、桃仁油，麦胚油、油茶油，蓖麻油，亚麻子油，红花油，棉籽油，紫苏子油，大豆油、花生油、茶籽油、榧子油、米糠油、西蒙得木油、杏仁油、橄榄油、胡萝卜油、葡萄籽油、菜籽油、山茶油、卵黄油、羊毛脂油、貂油等动植物油类；甘油、双甘油、三甘油、三辛酸甘油、三异棕榈酸甘油等甘油。 That is, liquid paraffin, squalene, squalane hydrocarbon oil; oleic acid, tall oil, isostearic high fatty acid; lauryl alcohol, oleyl alcohol, isostearyl alcohol, octyl alcohol, lauryl alcohol and other senior; A polysiloxane, phenylmethyl polysiloxane, methyl hydrogen polysiloxane, ten methyl polysiloxane silicone oil; isopropyl myristate, isopropyl palmitate, hexyl laurate, oleyl oleate, decyl oleate, octyldodecyl myristate, cetyl dimethyl octanoate, diethyl phthalate, dibutyl phthalate and other esters; Avocado oil, camellia oil, turtle oil, macadamia nut oil, corn oil, sesame oil, peach kernel oil, wheat germ oil, camellia oil, castor oil, linseed oil, safflower oil, cottonseed oil, perilla oil, soybean oil, peanut oil , tea seed oil, kaya oil, rice bran oil, jojoba oil, almond oil, olive oil, carrot oil, grape seed oil, rapeseed oil, camellia oil, egg yolk oil, lanolin oil, mink oil, animal and plant oils; glycerol , diglycerol, triglycerol, trioctanoate glycerol, tri-iso-palmitic acid, glycerol and other glycerol. 蜡润滑剂的熔点可根据这些原料的分子量或组分比而适当调整。 According to molecular weight or the composition ratio of these raw materials and the melting point of wax lubricant appropriately adjusted.

[0165] 蜡润滑剂的分子量没有特别限定，但优选对其适当调整，以便不破坏获得的骨填充材的物理特性，例如，其重量平均分子量可以是1 X IO2〜1 X 106。 [0165] The molecular weight of wax lubricant is not particularly limited, but it is preferably appropriately adjusted, so as not to destroy the physical properties of the resultant bone filling material, for example, the weight average molecular weight may be 1 X IO2~1 X 106. 粘结剂中的蜡润滑剂的含量没有特别限定，但优选对其适当调整，以便不破坏获得的骨填充材的物理特性，如1重 The binder content of the wax lubricant is not particularly limited, but it is preferably appropriately adjusted so as not to destroy the bone filling material physical properties, such as a re-

量％〜50重量％。 Amount% ~ 50% by weight.

[0166] 热塑性树脂可以是缩醛树脂、（甲基）丙烯酸树脂、聚烯烃树脂、乙烯-醋酸乙烯酯共聚物、聚乙烯醇缩丁醛中的一种或两种以上。 [0166] The thermoplastic resin may be a polyacetal resin, (meth) acrylic resins, polyolefin resins, ethylene - vinyl acetate copolymer, polyvinyl butyral of one or two or more kinds. 本发明中的热塑性树脂优选采用除（甲基）丙烯酸树脂和（甲基）丙烯酸类树脂以外的树脂。 The thermoplastic resin of the present invention is preferably used in a resin other than the (meth) acrylic resins and (meth) acrylic resin. 其中，优选采用乙烯-醋酸乙烯酯共聚物。 Among them, the use of ethylene - vinyl acetate copolymer.

[0167] 热塑性树脂的分子量没有特别限定，但优选对其适当调整，以便不破坏获得的骨填充材的物理特性，例如，其重量平均分子量可以是IXio3〜11X105。 [0167] molecular weight of the thermoplastic resin is not particularly limited, but it is preferably appropriately adjusted, so as not to destroy the physical properties of the resultant bone filling material, for example, the weight average molecular weight may be IXio3~11X105. 粘结剂中的蜡润滑剂的含量没有特别限定，但优选对其适当调整，以便不破坏获得的骨填充材的物理特性，如 The binder content of the wax lubricant is not particularly limited, but it is preferably appropriately adjusted so as not to destroy the bone filling material physical properties, e.g.

1重量％〜50重量％。 1 wt% ~ 50 wt%. [0168] 润滑剂（除蜡润滑剂以外的润滑剂）可以是：硬脂酸、硬脂酸盐、硬脂酸水合物、硬脂酸盐水合物W1-C5烷基硬脂酸（C1-C5烷基表示具有1〜5个碳原子的烷基。下面与此相同。）中的一种或二种以上；或者它们之一与聚乙二醇；或者它们之一与聚甘油。 [0168] lubricant (other than wax lubricant lubricant) may be: stearic acid, stearate, stearic acid hydrate, hydrate stearate W1-C5 alkyl stearate (C1- C5 alkyl group represents an alkyl group having 1 ~ 5 carbon atoms, and the same below) in one or two or more kinds;.., or one of them with polyethylene glycol; or one of them with polyglycerol. 润滑剂的含量没有特别限定，但优选对其适当调整，以便不破坏获得的骨填充材的物理特性，如0. 5 重量％〜15重量％。 Content of the lubricant is not particularly limited, but it is preferably appropriately adjusted, so as not to destroy the physical properties of the obtained bone filling material, such as 0.5 wt% ~ 15 wt%. 通过采用这些润滑剂，可容易地将成型体从模具中取出。 By using these lubricants, it can be easily molded article removed from the mold. 此外，润滑剂也可起到分散剂的作用。 In addition, the lubricant also acts as a dispersant.

[0169] 邻苯二甲酸酯类是另一种构成粘结剂的化合物。 [0169] Phthalates are another compound binder composition. 据报道，邻苯二甲酸酯类对生物体有害，因此，优选实施方式中让粘结剂大致完全热分解，从而也可让粘结剂中含有邻苯二甲酸酯类这种生物亲和性较差的化合物。 It is reported that phthalates harmful organisms, therefore, the preferred embodiment allows substantially complete thermal decomposition of the binder, which also allows phthalates such biological affinity binder contains poor compound. 这种邻苯二甲酸酯类可以是邻苯二甲酸二丁酯等的C1-C5烷基邻苯二甲酸盐。 This may be a phthalate ester such as dibutyl phthalate C1-C5 alkyl phthalates. 通过采用这种邻苯二甲酸酯类，可获得物理特性更好的骨填充材。 By adopting such phthalates, better physical properties obtained bone filler.

[0170] 邻苯二甲酸酯类的分子量没有特别限定，但优选对其适当调整，以便不破坏获得的骨填充材的物理特性，例如，其重量平均分子量可以是1 X IO4〜1 X 107。 [0170] molecular weight phthalate esters is not particularly limited, but it is preferably appropriately adjusted, so as not to destroy the physical properties of the resultant bone filling material, for example, the weight average molecular weight may be 1 X IO4~1 X 107. 邻苯二甲酸酯类优选是不易挥发的物质。 Phthalates are preferably non-volatile substances. 邻苯二甲酸酯类的含量没有特别限定，但优选对其适当调整，以便不破坏获得的骨填充材的物理特性，例如，0重量％〜20重量％，优选为0. 5重量％〜15 Phthalates content is not particularly limited, but it is preferably appropriately adjusted, so as not to destroy the physical properties of the resultant bone filling material, for example, 0 wt% ~ 20 wt%, preferably 0.5 ~ 15 wt%

重量％。 % By weight.

[0171] 粘结剂可在后面的粘结剂去除工序等中通过热分解等去除。 [0171] binders may be in the back of the binder removal process or the like removed by thermal decomposition. 即，具有粘结剂的部分基本上变成空隙。 I.e., the portion having the adhesive becomes substantially void. 因此，通过控制加在原材料中的粘结剂的量，可调整获得的骨填充材的空隙率和强度。 Thus, by controlling the amount of raw materials added to the binder, the obtained bone filler adjustable porosity and strength. 但通常情况下，需要在原材料的粒子之间填充足够量粘结剂。 But usually, it is necessary between the particles filled with a sufficient amount of a binder material. 其原因在于，如果粘结剂的添加量太少，则不能获得适当的流动性，从而会引起缺料或空缝等成型缺陷以及获得的成型体的形状或密度不均勻的缺陷。 The reason is that, if the amount of the binder is too small, you can not get adequate liquidity, which will lead to lack of material or empty joints and other molding defects and uneven shape or density obtained shaped body defects. 因此，在原材料的重量为100重量份的情况下，粘结剂的添加量可以是10重量份〜100重量份，也可以是20重量份〜50重量份。 Thus, under the weight of the raw materials is 100 parts by weight, the amount of the binder may be ~ 100 parts by weight 10 parts by weight, may be ~ 50 parts by weight 20 parts by weight. 原材料与粘结剂的配比可以是25容积％〜70容积％，优选为30容积％〜55容积％，更优选为35容积％〜45容积％。 Raw materials and the binder volume ratio may be 25% ~ 70 volume%, preferably 30 vol% ~ 55 vol%, more preferably 35 vol% ~ 45 vol%.

[0172] 对于骨填充材的制造方法，其优选实施例为，在“具有钙类物质的原材料和具有粘结剂的材料”中含有玻璃成分。 [0172] The method for producing a bone filling material, which is the preferred embodiment is in the "raw material having a calcium-based material and having a binder material" contains a glass component. 玻璃成分可以是：以二氧化硅为主要成分的石英玻璃；含有5重量％〜20重量％的化03的硼硅酸盐玻璃；含有5重量％〜40重量％的铅的铅玻璃；含有5重量％〜30重量％的钾的钾玻璃；具有氟化钠、氟化铝、氟化锶的氟铝硅酸盐玻璃；或这些玻璃中之一与硼酸、氧化镧、氧化钆、氧化铌、氧化锆或钡中一种或两种以上的混合物。 Glass component may be: silica as the main component of quartz glass; containing 5 wt% of 03 ~ 20% by weight of the borosilicate glass; containing 5 wt% ~ 40% by weight of lead glass lead; containing 5 wt% ~ 30% by weight of potassium potassium glass; with sodium fluoride, aluminum fluoride, strontium fluoride, aluminum fluoride silicate glass; one of these, or glass with boric acid, lanthanum oxide, gadolinium oxide, niobium oxide, zirconium or barium oxide of one or a mixture of two or more. 通过加入玻璃成分，可降低烧结体的烧结性，在烧结体上形成微小的裂缝和孔，从而可获得适于培养细胞的优选骨填充材。 By adding glass components, can reduce the sintering of the sintered body, the sintered body formed small cracks and holes, thereby obtaining a bone filler is preferably suitable for culturing cells. 此外，因玻璃成分可提高骨填充材的强度，所以即使产生裂缝和孔，也可获得具有希望强度的骨填充材。 In addition, because the glass component can enhance the strength of the bone filling material, even if the cracks and holes having a desired strength can be obtained bone filler. 玻璃成分可以采用钛、钛合金、钴铬合金、不锈钢、氧化铝、氧化锆或适量这些物质的混合物。 Glass component may be used titanium, titanium alloys, cobalt-chromium alloy, stainless steel, alumina, zirconia, or mixtures of these substances amount. 也可采用磷灰石（Caltl(PO4)6O)等的磷酸钙类结晶或CaO-SiO2-MgO-P2O5类结晶玻璃等的磷酸钙类结晶玻璃。 May also be apatite (Caltl (PO4) 6O) calcium phosphates such as crystalline or CaO-SiO2-MgO-P2O5 glass like crystalline calcium phosphate crystalline glass.

[0173] 优选根据所需的骨填充材物理特性来适当调整玻璃成分的添加量，例如，在原材料的重量为100重量份的情况下，玻璃成分的添加量可以是1重量份〜20重量份，也可以是2重量份〜10重量份。 [0173] Preferably appropriately adjusting the amount of the glass component of a bone filler according to the required physical properties, for example, under the weight of the raw materials is 100 parts by weight, the addition amount of the glass component may be ~ 20 parts by weight 1 part by weight , it may be 2 ~ 10 parts by weight parts by weight. 混炼材料中玻璃成分的配比可以是1容积％〜20容积％，优选为2容积％〜10容积％，更优选为3容积％〜10容积％。 The ratio of the glass component in the kneaded material may be 1 vol% ~ 20 vol%, preferably 2 vol% ~ 10 vol%, more preferably 3 vol% ~ 10 vol%.

[0174] 对于骨填充材的制造方法，其优选实施例为，在“具有钙类物质的原材料和具有粘结剂的材料”中含有盐分或糖分（优选为盐分）。 [0174] The method for producing a bone filling material, which is the preferred embodiment is in the "raw material having a calcium-based material and having a binder material" containing salt or sugar (preferably salt). 若含有盐分或糖分，则可降低烧结体的烧结性，在烧结体上形成微小的裂缝和孔，从而可获得适于培养细胞的优选骨填充材。 If they contain salt or sugar, it can reduce the sintering of the sintered body, the sintered body in tiny cracks and holes, thereby obtaining a preferred bone filling material suitable for culturing cells. 在获得骨填充材后，通过将其浸渍到水等中可除去盐分或糖分，获得多孔质的骨填充材，从而可获得适于培养细胞的优选骨填充材。 After obtaining bone filler, by dipping into the water like salt or sugar can be removed, to obtain porous bone filling material, thereby obtaining a bone filler is preferably suitable for culturing cells. 作为盐分或糖分，可根据情况采用公知的盐分或糖分。 As salt or sugar, it may be a known salt or sugar according to the situation. 盐分是可在水等中溶解但不在粘结剂的热分解温度下热分解的盐分，尤其优选无机盐，具体而言，可以是氯化钠、氯化钾、氯化钙或碳酸钙。 Salt is not dissolved but the binder thermal decomposition under the thermal decomposition temperature of the salt in water or the like, particularly preferably an inorganic salt, specifically, sodium chloride, potassium chloride, calcium chloride or calcium carbonate. 作为糖分，可根据情况采用蔗糖、葡萄糖、果糖等公知的糖分。 As sugar, you can use sucrose, glucose, fructose and other sugars known under the circumstances. 本发明的优选实施例是，在含有盐分或糖分或者不含有盐分或糖分这两种情况下加入热分解成分。 A preferred embodiment of the present invention is that containing or not containing salt or sugar is added at the thermal decomposition component salt or sugar in both cases. 热分解成分是指，在混合工序中不热分解但在成型工序和烧结工序中热分解或在比成型工序和烧结工序中的加热温度高的温度下热分解的成分。 Component refers to the thermal decomposition, in the mixing step, but it is not thermally decomposed in the molding step and the sintering step or in the thermal decomposition ratio molding step and sintering step of heating the thermal decomposition temperature of the high temperature components. 由于这种热分解成分在成型中、烧结中、烧结后的任何一个阶段都可热分解，所以可获得具有适当空隙的骨填充材。 Because of the thermal decomposition component molding, sintering, any stage after sintering can be thermally decomposed, so that appropriate voids can be obtained with a bone filler.

[0175] 优选根据所需的骨填充材物理特性来适当调整盐分或糖分的添加量。 [0175] Preferably appropriately adjusting the amount of salt or sugar based on the desired physical properties of bone filler. 例如，在原材料的重量为100重量份的情况下，盐分或糖分的添加量可以是1重量份〜20重量份，也可以是2重量份〜10重量份。 For example, under the weight of the raw materials is 100 parts by weight, the amount of salt or sugar may be 1 ~ 20 parts by weight parts by weight, 2 parts by weight may be ~ 10 parts by weight. 混炼材料中盐分或糖分的配比可以是1容积％〜30容积％， 优选为2容积％〜20容积％，更优选为3容积％〜10容积％。 Salt or sugar kneaded material ratio may be 1 vol% ~ 30 vol%, preferably 2 vol% ~ 20 vol%, more preferably 3 vol% ~ 10 vol%. 此外，在添加有热分解成分的情况下，优选添加等量的盐分或糖分。 Further, in the thermal decomposition component is added, it is preferable to add the same amount of salt or sugar.

[0176] 混炼工序中，对所述原料粉末和粘结剂等进行混合，由此获得用于注塑成型的化合物。 [0176] kneading step, the raw material powder and a binder, etc. are mixed, thereby obtaining a compound for injection molding. 若原料粉末未均勻混合，则会出现成型体的外形尺寸不佳等问题。 If the raw material powder is not uniformly mixed, the poor and other dimensions of the molded body problem occurs. 尤其是，从药物加入量为定量的角度来看，由于优选所述骨填充材的形状是固定的，所以尽量让原料均勻混 In particular, from the drug addition is a quantitative point of view, since the shape is preferred that the bone filling material is fixed, so try to make the raw materials were evenly mixed

I=IO I = IO

[0177] 优选根据粘结剂的种类等适当调整混炼工序中的温度。 [0177] kneading step is preferably appropriately adjusted depending on the kind of temperature binder. 若该温度太低，则粉末状原料和粘结剂不易混合，若该温度太高，则粘结剂容易热分解，所以该温度可以是110°c〜 240°C，优选为130°C〜190°C，更优选为140°C〜160°C。 If the temperature is too low, the powdered material and difficult to mix a binder, if the temperature is too high, the adhesive easily thermally decomposed, so that the temperature can be 110 ° c~ 240 ° C, preferably 130 ° C~ 190 ° C, more preferably 140 ° C~160 ° C.

[0178] 为了让原料均勻混炼，混炼工序中需要很长的时间。 [0178] In order to allow a uniform mixing of raw materials, the kneading step, it takes a long time. 但是，如果该时间太长，粘结剂则会在混炼过程中热分解。 However, if the time is too long, the binder is thermally decomposed in the mixing process. 因此，优选根据粘结剂的种类等适当调整混炼工序的时间，该时间可以为30分钟〜5小时，也可以是45分钟〜1. 5小时。 Thus, depending on the type binder preferably appropriately adjusted kneading step time, the time may be 30 minutes ~ 5 hours, 45 minutes may be ~ 1. 5 hours.

[0179] 混炼工序中采用的混炼机例如可以是加压式混炼机、单轴或双轴挤出式混炼机。 [0179] kneading step of kneading machine used for example be pressurized mixer, a uniaxial or biaxial extrusion kneader. 由于本发明所获得的骨填充材是准备用于移植的医疗器械，所以最好避免因混炼机的叶片磨损而使得骨填充材中混入杂质的情况。 Since the bone filling material of the present invention is to prepare for the transplant to get medical devices, so it is best to avoid the blade mixer wear and makes the case the bone filling material mixed impurities. 从这一点来看，混炼机的叶片最好由硬度高的材料制成，优选采用进行了表面处理而具有锡涂层等表面保护层的叶片。 From this point of view, the blades of the mixer is preferably made of a material with high hardness, preferably using surface-treated tin coating or the like and having a blade surface protective layer.

[0180] 混炼工序例如可按如下方式进行。 [0180] kneading step, for example according to the following manner. 先将混炼机加热到预先设定的温度，然后将熔点高的粘结剂投入混炼机。 First mixer is heated to a predetermined temperature, and then the high melting point of the binder into the mixer. 在粘结剂的熔融进行到一定程度之后，投入原料粉末。 After the molten binder to a certain extent, into the raw material powder. 然后，将熔点低的粘结剂与原料粉末一起投入混炼机，在投入1/2容积量〜4/5容积量的原料后， 投入DBP(邻苯二甲酸二丁酯）等低挥发性成分，然后投入剩余的原材料。 Then, the low melting point material powder together with a binder into a kneader in an amount invested ~ 4 1/2 volume / volume amount of material 5, the input DBP (dibutyl phthalate) and other low volatility composition, then put the remaining raw materials. 这样，通过在混炼工序开始时就混炼高熔点的粘结剂（高粘性）和原料粉末，可使粉末的集合体分散。 Thus, at the beginning of the kneading step of kneading a binder a high melting point (high viscosity) and the raw material powder, the powder can aggregate dispersed.

[0181] 具体而言，向混炼机投入（甲基）丙烯酸类树脂和所述乙烯-醋酸乙烯酯共聚物， 在混炼二者的同时，向混炼机中投入所述原材料、所述固体石蜡和所述硬脂酸，在混炼这些物质的同时，再向混炼机中投入所述邻苯二甲酸二丁酯。 [0181] Specifically, the inputs to the mixer (meth) acrylic resin and the ethylene - vinyl acetate copolymer, both at the same time in the mixing, kneader was charged to the raw material, the paraffin wax and the stearic acid, while mixing these substances into the mixer again dibutyl phthalate. 通过按这种方式来进行混炼，可获得注塑成型所用的混合物。 In this manner kneading, the obtained mixture is used for injection molding through. [0182] 但因本发明中所获得的骨填充材今后可取代骨，所以可通过在成型品上设置较小的裂缝来促进对骨的取代。 [0182] but the bone filling material of the present invention can be obtained in the future replace the bone, so by setting a small crack in the molded product to promote substitute for bone. 从这一点来看，混炼时间例如可以是15分钟〜30分钟，也可以是80°C〜100°C。 From this point of view, for example, the kneading time may be 15 minutes ~ 30 minutes, may be 80 ° C~100 ° C.

[0183] 成型工序是用于通过注塑成型获得规定形状成型体的工序。 [0183] forming step is a step for obtaining a predetermined shape of the molded body by injection molding step. 骨填充材优选具有从正四面体的中心向各顶点延伸的4个突起部的形状，下面对用于制造这种骨填充材的模具的例子进行说明。 Bone filler preferably has from the center of the regular tetrahedron form four projections each apex portion extending below for example for manufacturing such bone filling material of the mold will be described. 所述模具可包括固定侧模具和活动侧模具，其中，固定侧模具上设置有用于注入材料的注入口（门）；活动侧模具在注入材料时与所述固定侧模具接触但在成型后与所述固定侧分开。 The mold may include a fixed side mold and a movable side mold, which is provided on the fixed side mold has an injection port for injecting material (gate); movable-side mold in contact with the fixed-side mold when injection molding the material but after the separated from the fixed side.

[0184] 成型工序中优选采用注塑成型机来进行注塑成型。 [0184] In the molding step is preferably carried out using an injection molding machine to injection molding. 注塑成型机没有特别限定，根据情况可采用公知的注塑成型机。 Injection molding machine is not particularly limited, depending on the circumstances and a known injection molding machine. 注塑成型机可以是立式或卧式；高压式、中压式或低压式；柱塞式或螺杆式等。 Injection molding machine can be vertical or horizontal; high-pressure, medium-pressure or low-pressure type; plunger or screw like. 其中，优选采用卧式螺杆式（优选采用高压式）注塑成型机，以便用所述磷酸钙类物质来制造微小的骨填充材。 Among them, a horizontal screw (preferably high pressure type) injection molding machine in order to use the calcium phosphate-based material to produce tiny bone filler. 但是，当螺杆或料筒的磨损等产生的杂质混入成型体时，虽然对于普通的成型体不会有什么大问题，但若想将骨填充材放在生物体内就有问题。 However, when the impurity screw or barrel wear produced mixed molded body, although there will not be any major problems for ordinary molded body, but if you want the bone filling material in vivo is a problem. 因此，优选在螺杆的表面上设置氮化钛涂层等磨损保护层。 Therefore, it is preferable to set a titanium nitride coatings wear protection layer on the surface of the screw.

[0185] 粘结剂去除工序是指，用于去除所述成型工序中获得的成型体所含的粘结剂以获得脱脂体的工序。 [0185] refers to a binder removal step for removing the binder obtained in the step of forming the molded body contained in the body to obtain a degreased step. 粘结剂去除工序也可称为脱脂工序。 A binder removal step may also be referred to as degreasing step. 若该粘结剂去除工序中没有彻底去除粘结剂，则会在后序的烧结工序中出现成型体皲裂或膨胀的情况。 If the binder removal step does not completely remove the binder, the molded body case chapped or expansion occurs in the subsequent sintering step. 人们希望的是，脱脂工序中在不出现变形或裂开等缺陷的情况下完成对粘结剂的去除。 It is hoped that the completion of the removal of degreasing process binder without deformation or dehiscence defects. 去除粘结剂的方法有升华法、自然干燥法、溶剂抽出法以及加热脱脂法等多种方法，其中，优选加热脱脂法。 The method of removing the binder sublimation method, various methods of natural drying method, a solvent extraction method, and heating degreasing method, which is preferably heated degreasing. 加热脱脂法又包括在大气环境下、减压环境下、加压环境下以及保护气体环境下进行等多种方法， 其中，优选在大气环境下进行加热脱脂。 Degreasing method also includes heating under atmospheric conditions, a reduced pressure environment, pressurized environment, and carried out under protective gas and other methods, including, preferably at atmospheric heating degreasing. 在将成型体投入脱脂炉时，优选将该成型体放置在陶瓷定位机上（多孔致密质）。 When the molded body into degreasing furnace, preferably the molded body is placed in a ceramic positioning machine (porous dense matter). 当成型体比较大时（壁较厚），优选采用氧化铝等的多孔质定位机。 When large molding time (thick walls), preferably a porous alumina and other positioning machine. 此外，最好注意定位机上的污垢和定位机加热后其上掉下的部分，以避免它们成为杂质混在成型体内。 In addition, the best attention after dirt and positioning machine positioning machine on the fall portion of their heating, to prevent them from becoming mixed in molding the body of impurities.

[0186] 粘结剂去除工序中，例如相应于粘结剂所含树脂的热分解温度，具有多级升温时间和维持时间。 [0186] In the binder removal step, e.g., heat corresponding to the decomposition temperature of the binder contained in the resin, and having a multi-stage heating time duration. 尤其可通过使热分解温度较低的树脂有效地热分解来提高烧结性。 In particular, low temperature decomposition of the resin can heat efficiently by thermal decomposition to improve sinterability. 本发明中，由于使温度上升，所以可使热分解温度较低的树脂有效地热分解。 In the present invention, since the temperature rises, so can lower the thermal decomposition temperature of the resin is thermally decomposed efficiently. 在优选实施方式中， 不管骨填充材是否填充在生物体内，粘结剂中都可含有生物体亲和性不佳的化合物。 In a preferred embodiment, regardless of whether the bone filler is filled in the living body, can be poor in the adhesive biocompatible compound. 多数情况下，这种化合物是熔点特别低的粘结剂。 In most cases, these compounds are particularly low melting point of the binder. 因此，为了在升温工序中使熔点较低的粘结剂完全蒸发，优选使温度较缓慢地上升。 Therefore, in order to lower the melting point of the binder is completely evaporated in the heating step manipulation, it is preferable that the temperature rises more slowly. 具体而言，在温度达到110°c〜300°C的第一维持期间之前（优选在达到230°C〜250°C的期间内)，按照1°C /小时〜3X 102°C /小时的方式来升温，优照选按1X10°C /小时〜2X102°C /小时的方式来升温，更优选按照2X10°C / 小时〜5X 10°C /小时的方式来升温，或按照3X 10°C /小时〜4X 10°C /小时的方式来升温。 Specifically, before the temperature reaches 110 ° c~300 ° C a first sustain period (preferably in the period reached 230 ° C~250 ° C), and according to 1 ° C / hr ~3X 102 ° C / hr way to heat up, preferably selected according to press 1X10 ° C / hour ~2X102 ° C / hour way to heat up, and more preferably in accordance with 2X10 ° C / hour ~5X 10 ° C / hour way to heat up, or in accordance with 3X 10 ° C / hr ~4X 10 ° C / hour way to heat up. 维持工序例如可以为2X 10分钟〜5小时，优选为3X 10分钟〜2小时。 Maintaining step may be, for example 2X 10 分钟 ~ 5 hours, preferably from 3X 10 分钟 ~ 2 hours.

[0187] 烧结工序是用于对粘结剂去除工序中获得的成型体进行加热的工序。 [0187] The sintering step is a step for removing the binder in the molded body obtained in the heating step. 如日本发明专利公开公报特开2004-97259号（所述专利文献1)所记载，在125°C下烧结1小时（该公报的【0025】段）。 As described in Japanese Unexamined Patent Publication No. 2004-97259 (Patent Document 1) described sintered one hour ([0025] section of the bulletin) at 125 ° C under. 但本发明的优选实施方式是，将成型体从大气环境加热到最高温度为9X102°C〜1. 1X103°C的状态。 However, the preferred embodiment of the present invention is molded from the atmosphere is heated to a maximum temperature of state 9X102 ° C~1. 1X103 ° C for. 这是为了在例如采用α-TCP等原材料的情况下，有效地将其转换成β-TCP。 This is for example in the use of α-TCP in the case of other raw materials, effectively converted into β-TCP. 高温维持时间例如可以为5X KT1小时〜3小时。 Temperature holding time may be e.g. 5X KT1 hours ~ 3 hours. 烧结工序中，在升温 Sintering step, heating

30工序（及维持工序）之后通常是冷却工序。 30, after step (and maintaining step) is typically a cooling step. 冷却工序可采用公知的冷却方法。 A cooling step of cooling may be employed a known method. 包括冷却时间在内的烧结时间例如可以为6小时〜5X10小时，优选为1X10小时〜3X10小时。 Including the cooling time, including for example, the sintering time is 6 hours ~5X10 hours, preferably 1X10 hours ~3X10 hours. 成型温度可以为1X102°C〜1.5X102°C。 Forming temperature may 1X102 ° C~1.5X102 ° C. 模具温度可以为1X10°C〜3X10°C。 The mold temperature may be 1X10 ° C~3X10 ° C.

[0188] 后处理工序是用于对烧结后的成型体进行后处理的可选性工序。 [0188] After the treatment step is used after the optional step of sintering the molded body after the treatment. 具体而言，如消除推杆痕迹和清洗成型体。 Specifically, as the elimination of traces and cleaning molded putter.

[0189] 除了原料粉末以外，优选添加其他公知的药剂。 [0189] In addition to the raw material powder is preferably added to other known agents. 这样，由于本发明所制造的骨填充材的体积大致相同，所以骨填充材可起到药剂载体的作用。 Thus, since the volume of the present invention produced substantially the same as bone filler, bone filler can therefore act as a carrier agent. 该添加的药剂优选为高温下也不会破坏其活性的药剂。 The agent is preferably added at a high temperature does not destroy its activity agents.

[0190] 骨填充材也可称作为骨填补剂，其被填充在骨缺损部位。 [0190] bone filling material can also be referred to as a bone filling material, which is filled in the bone defect site. 骨填充材可以以其自身的状态保持在生物体内，但优选替代生物体内的骨组织。 Bone filler can be kept in their own state in the living body, but preferably in vivo bone tissue substitute. 骨填充材的组分可采用公知的组分，如具有钙类物质的组分。 Component and a known component of bone filler, such as calcium-based material having a component. 钙类物质可以是磷酸钙类物质、碳酸钙类物质或二者，具体而言，可以是羟基磷灰石、碳酸磷灰石、氟磷灰石、氯磷灰石、β-TCP、α-TCP、偏磷酸钙、磷酸四钙、磷酸八钙、磷酸氢钙、磷酸二氢钙、焦磷酸钙、它们的盐或溶剂化物中任意一种或任意两种以上。 Calcium-based material may be a calcium phosphate-based materials, calcium carbonate or both substances, specifically, hydroxyapatite, carbonate apatite, fluorapatite, chlorapatite, β-TCP, α- TCP, calcium metaphosphate, tetracalcium phosphate, octacalcium phosphate, calcium hydrogen phosphate, calcium dihydrogen phosphate, calcium pyrophosphate, salts thereof or solvate thereof of any one or any two or more.

[0191] 本发明中，优选骨填充材内含有适当药剂。 [0191] The present invention, preferably the bone filling material containing the appropriate drug. 具体而言，在制造骨填充材的工序中， 优选在磷酸钙类物质等骨填充材的主要成分中添加适当药剂。 Specifically, in the step of producing a bone filling material, it is preferred to add the appropriate agent in the main component of calcium and other substances in bone filler.

[0192] 本发明中，还优选在制造的骨填充材上浸渍或涂敷适当药剂。 [0192] The present invention further bone filling material is impregnated or coated with an appropriate agent is preferably manufactured. 药剂的涂敷方法包括浸渍涂敷法、喷射涂敷法和旋转涂敷法。 Coating agents include dip coating method, spray coating method and spin coating method. 即，先让药剂溶解在公知的药剂学所允许的稀释剂（溶剂）中，获得医药组合物，再利用该医药组合物来进行所述浸渍涂敷、喷射涂敷或旋转涂敷。 That is, let the drug is dissolved in a known pharmaceutically allowable diluent (solvent) to obtain a pharmaceutical composition, and then using the pharmaceutical composition to the dip coating, spray coating or spin coating. 其中，优选浸渍涂敷。 Among them, dip coating is preferred. 当将药剂浸渍涂敷在骨填充材上时，药剂则浸渍在骨填充材的表面或内部。 When dip coating agent in bone filler, the agent is impregnated on the surface or inside a bone filler. 即，本发明可提供一种浸渍或涂敷有规定药剂的骨填充材。 That is, the present invention provides a pharmaceutical impregnated or coated with the provisions of the bone filler. 下述药剂可混合在通过RP法等制造骨填充材时所用的原料内。 The following agents can be mixed within the manufacture by bone filler material used in RP method.

[0193] 本发明骨填充材的优选实施方式是，所述药剂包括骨或软骨形成促进剂（具有软骨形成促进因子）、关节疾病治疗剂、骨或软骨疾病预防剂、骨或软骨疾病治疗剂、骨再生剂、骨吸收抑制剂、血管新生促进剂、抗菌剂、抗生素或抗癌剂。 [0193] preferred embodiment of the present invention is a bone filler, the agent comprises a bone or cartilage formation promoting agent (having a chondrogenesis promoting factor), a joint disease therapeutic agent, a bone or cartilage disease preventive agent, a therapeutic agent of bone or cartilage diseases , bone regeneration agents, bone resorption inhibitors, angiogenesis promoter, an antibacterial agent, an antibiotic or anti-cancer agents. 本发明骨填充材的优选实施方式是，所述药剂包括下述分子结构（1)所表示的噻吩并吲唑衍生物（thienoindazole derivative) 0该分子结构（1)所表示的噻吩并吲唑衍生物（4，5_ 二氢甲基-IH-噻吩[3,4-g]吲唑衍生物)例如可按照日本发明专利公开公报特开2002-356419号所记载的方法来制造。 A preferred embodiment of the present invention is a bone filler, the agent comprising molecular structure (1) and thiophene represented indazole derivative (thienoindazole derivative) 0 The molecular structure of (1) and thiophene represented indazole derivative matter (4,5_ dihydro-methyl -IH- thiophene [3,4-g] indazole derivatives), for example in accordance with Japanese Patent Laid-open No. 2002-356419 described method of manufacturing. 优选本发明的骨填充材中含有有效量的药剂，以获得规定的效果。 Bone filler in the present invention preferably comprises an effective amount of an agent, in order to obtain the specified effect. 即，因本发明中可采用公知的药剂，所以可根据情况调整该药剂的含量，以便在骨填充材中加入所需量(有效量）的药剂，从而可在其特定用途上有效地发挥作用。 That is, since the present invention may be a known drug, it is possible to adjust the content of the agent according to the situation, in order to join the required amount (effective amount) of the agent in the bone filling material, which can effectively play a role in its specific uses .

[0194] [0194]

[0195](分子结构（1)中，R1 可以是羧酰胺基（-CH(NH2) (CO2H)), -CH(NH2) (SO3H)，-CH(NH2) (SO2NHRn)，-CH(NH2) (P0 (NH2) OH 以及-CH(NH2) (P0 (OR11) OH)(其中，分子结构中的Rn表示碳原子为1〜5的直链烷基）。R1优选是羧酰胺基。） [0195] (Molecular Structure (1), R1 may be a carboxamide group (-CH (NH2) (CO2H)), -CH (NH2) (SO3H), - CH (NH2) (SO2NHRn), - CH (NH2 ) (P0 (NH2) OH and -CH (NH2) (P0 (OR11) OH) (wherein Rn represents the molecular structure of 1 ~ 5 carbon atoms, a straight-chain alkyl) .R1 is preferably a carboxamide group.)

[0196] 骨或软骨形成促进剂是可促进骨或软骨形成的药剂，其可采用公知的药剂，具体而言，软骨形成促进剂可以是国际公开2002-087620号小册子所公开的如下物质，即， 2- [1- (2，2- 二乙氧基-乙基）-3- (3-对甲苯基-脲基）-2，3- 二氢-IH-吲哚-3-基]-N-对甲苯基-乙酰胺Q-[l—2，2-Diethoxy-ethyl)-3-(3-p-tolyl-ureido) -2, 3-dihydro-lH -ind0l-3-yl]-Np-t0lyl-acetamide)。 [0196] Bone or cartilage formation promoting agent is to promote the formation of bone or cartilage agent, which may be a known agent, specifically, cartilage formation promoting agent may be the following materials pamphlet of International Publication No. 2002-087620 disclosed, i.e., 2- [1- (2,2-diethoxy-ethyl) - 3- (3-p-tolyl - ureido) -2,3-dihydro--IH- indol-3-yl] -N- p-tolyl - acetamide Q- [l-2,2-Diethoxy-ethyl) -3- (3-p-tolyl-ureido) -2, 3-dihydro-lH -ind0l-3-yl] - Np-t0lyl-acetamide). 软骨形成促进剂可以是骨形成促进因子。 Chondrogenesis promoter may promote bone formation factor. 骨形成促进因子通常被称作为BMP (Bonemorphogenetic protein ；骨形成蛋白），该BMP是一种骨诱导物质或软骨诱导物质，其从细胞外作用在未分化的间充质细胞上，使其遗传性状分化为软骨细胞和造骨细胞。 Bone formation promoting factors are often referred to as BMP (Bonemorphogenetic protein; bone morphogenetic protein), which is a bone-inducing substance BMP or cartilage inducing substance, between its external action from cells in the undifferentiated mesenchymal cells to genetic traits differentiation into chondrocytes and osteoblasts. 骨形成促进因子可以是BMPl〜13。 Bone formation promoting factors may be BMPl~13. 本发明中，若采用BMP药剂时，该BMP既可以是基因重组的BMP，又可以是从Durm骨肉瘤中分离并纯化得到的BMPCTakaoka， k.，Biomedical Research，2 (5) 466-471 (1981))，其可通过公知的制造方法获得。 The present invention, if the use of BMP agent, which can be either BMP BMP gene recombination, and can be isolated and purified BMPCTakaoka, k from Durm osteosarcoma., Biomedical Research, 2 (5) 466-471 (1981 )), which can be obtained by known manufacturing methods.

[0197] 关节疾病治疗剂包括：p38MAP激酶抑制剂（W000/64894等中公开的噻唑类化合物等）；基质金属蛋白酶抑制剂（MMPI)；脱氢皮质醇、氢化可的松、甲基强的松龙、糖皮质激素类倍他米松以及倍他米松等抗炎症留体制剂；喷哚美辛、双氯芬酸、氯索洛芬、布洛芬、吡罗昔康、舒林酸等非留体类消炎止痛剂。 [0197] a joint disease therapeutic agents include: p38MAP kinase inhibitors (W000 / 64894, etc. disclosed thiazoles, etc.); matrix metalloproteinase inhibitor (MMPI); prednisolone, hydrocortisone, methylprednisolone Song Long, glucocorticoids betamethasone and betamethasone remain anti-inflammatory preparations; spray indole class of non-steroidal indomethacin, diclofenac, loxoprofen, ibuprofen, piroxicam, sulindac and other anti-inflammatory pain agent.

[0198] 骨或软骨疾病预防剂或者骨或软骨疾病治疗剂例如包括如下非肽类骨形成促进物质和难溶性肽类骨形成促进物质中任意一种或两种以上的混合物，该非肽类骨形成促进物质例如是前列腺素Al衍生物、维生素D衍生物、维生素K2衍生物、二十碳五烯酸衍生物、苄基磷酸、双膦酸衍生物、性激素衍生物、酚磺酞衍生物、苯并噻喃或苯并虑平(benzothiepine)的衍生物、噻吩并吲唑衍生物、四烯甲萘醌衍生物、赛菊芋黄素衍生物。 [0198] The prophylactic bone or cartilage or bone or cartilage disease therapeutic agent such as including the following non-peptide osteogenesis-promoting substance and insoluble peptides bone formation promoting substances in any one or a mixture of two or more of the non-peptide bone formation promoting substances such as prostaglandin Al derivatives, vitamin D derivatives, vitamin K2 derivatives, eicosapentaenoic acid derivatives, benzyl phosphoric acid, bisphosphonic acid derivative, sex hormone derivative, phenolsulfonphthalein derivatives , benzothiopyrano or benzo doxepin (benzothiepine) derivatives, thiophene and indole derivatives, four menatetrenone derivatives, flavin Jerusalem artichoke biological race. 这些物质中任何一种都可通过公知的方法获得。 Any of these substances can be obtained by a known method. 骨或软骨疾病预防剂中既可含有预防骨或软骨疾病发生病变的药剂，又可含有防止预防骨或软骨疾病发展的药剂，还可同时具有这两种药剂。 Bone or cartilage disease preventive agent containing a prophylactic agent either bone or cartilage disease lesions, but also contain agents to prevent the prevention of bone or cartilage disease progression, but also have both agents.

[0199] 骨再生剂包括如下物质中任意一种或两种以上的混合物，S卩，钙调蛋白、放射菌素D、环孢菌素A、硫酸葡萄糖胺、盐酸葡萄糖胺、骨髓提取物、磷酸钙、乳酸/羟乙酸/ ε -己内酯共聚物、富含血小板血浆、人骨髓间充质细胞。 [0199] Bone regenerative agents include any one of the following materials or a mixture of two or more, S Jie, calmodulin, actinomycin D, cyclosporine A, glucosamine sulfate, glucosamine hydrochloride, bone marrow extract, calcium phosphate, lactic acid / glycolic acid / ε - caprolactone, platelet rich plasma, human bone marrow mesenchymal cells. 这些物质均可通过公知的方法获得。 These substances can be obtained by known methods.

[0200] 骨吸收抑制物质包括雌激素剂、降血钙素以及二碳磷酸盐化合物中的任意一种或两种以上的混合物。 [0200] bone resorption inhibiting substance comprises estrogen agent, calcitonin, and bisphosphonate any one or a mixture of two or more. 这些物质均可通过公知的方法获得。 These substances can be obtained by known methods.

[0201] 血管新生促进剂包括如下物质中任意一种或两种以上的混合物，即，靛蓝胭脂红；4-[N-甲基-N-(2-苯基乙基）氨基]-1-(3，5-二甲基-4-丙氨基苯甲酰基）哌啶；4_(5H_7， 8,9,10-四氢-5，7，7，10，10-五甲基苯并[e]萘并[2，3_b] [1,4] 二氮杂草_13_基)苯甲酸；激活蛋白C ；尾加压素II样多肽化合物；成纤维细胞生长因子（FGF)(包括碱性FGF 和酸性FGF)；血管内皮细胞生长因子（VEGF)(优选血小板衍生因子）；肝细胞生长因子(HGF)；血管生成素（包括血管生成素-1和血管生成素_2。）；血小板衍生生长因子（PDGF)； 胰岛素样生长因子（IGF)或平滑肌胚胎型肌球蛋白重链（SMemb)。 [0201] Angiogenesis promoting agent comprises a mixture of the following substances in any one or two or more, i.e., indigo carmine; 4- [N- methyl -N- (2- phenylethyl) amino] -1- (3,5-dimethyl-4-propionyl aminobenzoyl) piperidine; 4_ (5H_7, 8,9,10- tetrahydro -5,7,7,10,10- pentamethyl benzo [e urotensin II like peptide compound;; activated protein C;] naphtho [2,3_b] [1,4] diazepin-_13_-yl) benzoic acid fibroblast growth factor (FGF) (including basic FGF and acidic FGF); vascular endothelial growth factor (VEGF) (preferably PDGF); hepatocyte growth factor (HGF); angiopoietin (including angiopoietin-1 and angiopoietin _2); platelet-derived growth factor (PDGF); insulin-like growth factor (IGF) or embryonic smooth muscle myosin heavy chain (SMemb). 其中，优选成纤维细胞生长因子(Hockel，M. etal. ,Arch. Surg.，No. 128，p. 423，1993)。 Wherein, preferably fibroblast growth factor (Hockel, M. Etal., Arch. Surg., No. 128, p. 423,1993). 成纤维细胞生长因子优选为碱性成纤维细胞生长因子（bFGF)，具体而言，如曲弗明（重组基因）。 Fibroblast growth factor is preferably basic fibroblast growth factor (bFGF), specifically, such as trafermin (gene recombinant). S卩，本发明骨填充材的一优选实施方式为，在所述骨填充材中，所述药剂具有曲弗明、其盐、其溶剂化物或其药物前体。 S Jie, a preferred embodiment of the present invention is a bone filler, the bone filler, the agent has trafermin, a salt thereof, or a solvate thereof before prodrugs. “其盐”是指曲弗明的盐，具体的盐与前面所述的盐相同。 "Salts" refers to salts trafermin, a salt of the same aforementioned specific salts. “其溶剂化物”是指曲弗明的溶剂化物，具体的溶剂化物与前面所述的溶剂化物相同。 "Solvate" refers to a solvate trafermin specifically the same solvate as previously described solvate. “其药物前体”是指曲弗明的药物前体，在其药物前体进入生物体内等后，会转变成曲弗明、其电离物（离子）或其盐等。 "Prodrug thereof" means trafermin of prodrugs, after its prodrug into a living body, etc., it will be transformed into trafermin, and other objects which ionization (ion) or a salt thereof. 具体而言，其药物前体具有氨基等保护基，该保护基在生物体内时会脱落，从而可与曲弗明起到相同的作用。 Specifically, its prodrug having an amino protecting group, the protecting group will fall off when the living body, which can be used with trafermin play the same role.

[0202] 抗菌剂或抗生素可采用公知的抗菌剂或抗生素。 [0202] Antibacterial agents or antibiotics may be known antimicrobials or antibiotics. 具体而言，抗菌剂或抗生素可以是如下物质中任意一种或两种以上的混合物。 In particular, an antibacterial agent or antibiotic can be a mixture of any of the following materials, one or two or more. 即，磺胺醋酰（sulfacetamide)、磺胺甲二唑（sulfamethizol)、磺胺二甲嘧啶（sulfadimidine)、磺胺甲基嘧啶等磺胺剂(sulfadiazine)；氯霉素(chloramphenicol :CP)、甲讽霉素(tiamphenicol)等氯霉素类抗菌剂；氧氟沙星(Ofloxacin =OFLX)、环丙沙星(ciprofloxacin =CPFX)、恩氟沙星(enrofloxacin)、洛米沙星（lomefloxacin =LFLX)、芦氟沙星（rufloxacin)、左氧氟沙星(levofloxacin :LVFX)、氟罗沙星（fleroxacin :FLRX)、那氟沙星（nadifloxacin =NDFX)、 诺氟沙星（norfloxacin :NFLX)、施怕沙星（sparfloxacin =SPFX)等喹啉酮类抗菌剂；梭链孢酸（fusidic acid =FA)；镰孢真菌素(fusafungine)；磷霉素(fosfomycin =FOM)；莫匹罗星（mupirocin :MUP)；溴莫普林(brodimoprim)；地红霉素（dirithromycin)；苄青霉素（benzylpenicillin =PCG)、普鲁卡因青霉素G(普鲁卡因青霉素G的盐，penicillin G procaine)、节星青霉素（节星青霉素的盐，benzathine penicillin)、苯氧甲基青霉素(phenoxymethylpenicillin ；Penicillin V)、甲氧苯青霉素（methicillin)、氨节青霉素（ampicillin :ABPC)、氯唑西林(cloxacillin :MCIPC)、羧节青霉素（carbenicillin)、 匹氨青霉素(pivampicillin :PVPC)、羟氨苄青霉素（AMPC)、酞氨西林(talampicillin ： TAPC)、巴氨西林(bacampicillin =BAPC)、替卡西林(ticarcillin =TIPC)、阿洛西林(azlocillin)、美洛西林（mezlocillin)、匹美西林(pivmeci llinam :PMPC)、哌拉西林(piperacillin :PIPC)、阿莫西林-克拉维酸(amoxicillin :AMPC/clavulanic_acid :CVA ； co-amoxiclav))、阿帕西林（apalcillin)、替莫西林（temocillin)、替卡西林-克拉维酸(ticarcillin/clavulanic acid :CVA)、氨卞西林-舒巴坦(ampicillin :ABPC/sulbactam ： SBT)、舒他西林(sultamicillin =SBTPC)、哌拉西林-他佐巴坦(piperacillin =PIPC/ tazobactam =TAZ)等青霉素类抗生素；链霉素（str印tomycin =SM)等链霉素类抗生素；氯四环素（chlortetracycline)、金霉素（aureomycin)、氯霉素(chloramphenicol :CP)、土霉素(oxytetracycline :0TC)、去甲氯四环素（demethylchlortetracycline)、去甲基金霉素、去甲基金霉素：注册商标、赖甲环素（lymecycline)、强力霉素(doxycycline =DOXY),二甲胺四环素（minocycline =MINO)等四环素类抗生素；新霉素（neomycin)、奇放线菌素（spectinomycin :SPCM)、庆大霉素(gentamycin :GM)、托普霉素（tobramycin ：Τ0Β)、阿米卡星（amikacin :AMK)、小诺米星（micronomicin :MCR)、异帕米星（is印amicin :ISP)、 阿贝卡星（arbekacin =ABK)等氨基糖苷类抗生素；红霉素（erythromycin :EM)、螺旋霉素(spiramycin :SPM)、罗红霉素（roxithromycin :RXM)、阿齐红霉素（azithromycin :AZM)、 麦迪霉素（midecamycin :MDM)、克拉仙霉素（clarithromycin =CAM)等大环内酯类抗生素； 万古霉素(vancomycin :VCM)、替考拉宁(teicoplanin =TEIC)等糖肽类抗生素；黏菌素(colistin =CL)等多肽类抗生素；维及霉素（virginiamycin)、普那霉素(pristinamycin) 等链阳性菌素类抗生素；氯林可霉素（clindamycin =CLDM)等林可霉素类抗生素；头孢氨苄(cephalexin :CEX)、头孢唑啉（cefazolin :CEZ)、头孢拉定（cefradine :CED)、头孢羟氨苄(cefadroxil :CDX)、头孢孟多（cefamandole :CMD)、头孢呋辛（cefuroxime :CXM)、头孢克洛(cefaclor :CCL)、头孢噻肟(cefotaxime :CTX)、头孢磺啶（cefsulodin :CFS)、头孢哌酮（cefperazone)、头孢替安（cefotiam :CTM)、头孢曲松（ceftriaxone :CTRX)、头孢甲月亏(cefmenoxime :CMX)、头孢他定，（ceftazidime :CAZ)、头孢唑B亏（ceftiroxime)、头孢羟苄磺唑（cefonicid)、头孢匹胺（cefpiramide :CPM)、头孢哌酮-舒巴坦(cefoperazone ： CPZ/sulbactam :SBT)、头孢泊肟(cefpodoxime :CPDX)、头孢地嗪（cefodizime)、头孢地尼（cefdnir =CFDN)、头孢他美（cefetamet =CEMT)、头孢匹罗（cefpirome :CPR)、头孢丙烯（cefprozil)、头孢丁烯（七7 工歹7 工>)(ceftibufen)、头孢吡肟（cef 印ime ： CFPM)等先锋霉素类抗生素；头孢西丁（cefoxitin =CFX)、头孢美唑（cefmetazole ： CMZ)、头孢替坦(cefotetan =CTT)等头霉素类抗生素；拉氧头孢（latamoxef :LM0X)、氟氧头孢（flomoxef :FM0X)等氧头孢烯类抗生素；亚胺培南一西司他丁（imipenem :IPM/ cilastatin =CS ；泰能：注册商标）等碳青霉烯类抗生素；氨曲南（aztreonam =AZT)等单环内酰胺类抗生素；氯拉卡比（Ioracarbef=LCBF)等碳头孢烯类抗生素；帕尼培南-倍他米隆（panipenem :PAPM/betamipron :BP)等碳青霉烯类抗生素；泰利霉素（telithromycin ： TEL)等酮内酯类抗生素。 That is, sulfacetamide (sulfacetamide), sulfamethizole (sulfamethizol), sulfamethazine (sulfadimidine), sulfamethyldiazine and other sulfonamides (sulfadiazine); chloramphenicol (chloramphenicol: CP), A satirical ADM ( tiamphenicol) and other antimicrobial agent chloramphenicol; ofloxacin (Ofloxacin = OFLX), ciprofloxacin (ciprofloxacin = CPFX), enrofloxacin (enrofloxacin), Luo Misha star (lomefloxacin = LFLX), Lo fluorine Sand star (rufloxacin), levofloxacin (levofloxacin: LVFX), fleroxacin (fleroxacin: FLRX), nadifloxacin (nadifloxacin = NDFX), norfloxacin (norfloxacin: NFLX), Shi afraid gatifloxacin (sparfloxacin = SPFX) and other quinolone antibacterial agents; fusidic acid (fusidic acid = FA); Fusarium fungus hormone (fusafungine); fosfomycin (fosfomycin = FOM); mupirocin (mupirocin: MUP); bromine Mopti Lin (brodimoprim); erythromycin (dirithromycin); benzyl penicillin (benzylpenicillin = PCG), procaine penicillin G (procaine penicillin G, penicillin G procaine), section Star penicillin (penicillin star section salt, benzathine penicillin), phenoxymethyl penicillin (phenoxymethylpenicillin; Penicillin V), methicillin (methicillin), ampicillin (ampicillin: ABPC), cloxacillin (cloxacillin: MCIPC), carboxymethyl section penicillin (carbenicillin) , horses ammonia penicillin (pivampicillin: PVPC), amoxicillin (AMPC), phthalocyanine ammonia Xilin (talampicillin: TAPC), bacampicillin (bacampicillin = BAPC), ticarcillin (ticarcillin = TIPC), azlocillin (azlocillin) mezlocillin (mezlocillin), horses Mecillinam (pivmeci llinam: PMPC), piperacillin (piperacillin: PIPC), amoxicillin - clavulanic acid (amoxicillin: AMPC / clavulanic_acid: CVA; co-amoxiclav)), A Pa Xilin (apalcillin), temocillin (temocillin), ticarcillin - clavulanate (ticarcillin / clavulanic acid: CVA), Ampicillin - sulbactam (ampicillin: ABPC / sulbactam: SBT), sultamicillin ( sultamicillin = SBTPC), piperacillin - tazobactam (piperacillin = PIPC / tazobactam = TAZ) penicillin and other antibiotics; streptomycin (str India tomycin = SM) streptomycin and other antibiotics; chlortetracycline (chlortetracycline), chlortetracycline (aureomycin), chloramphenicol (chloramphenicol: CP), oxytetracycline (oxytetracycline: 0TC), norepinephrine chlortetracycline (demethylchlortetracycline), norepinephrine fund neomycin, norepinephrine fund ADM: registered trademark, lymecycline (lymecycline), doxycycline (doxycycline = DOXY), minocycline (minocycline = MINO) and other tetracycline antibiotics; neomycin (neomycin), spectinomycin (spectinomycin: SPCM), gentamicin ( gentamycin: GM), tobramycin (tobramycin: Τ0Β), amikacin (amikacin: AMK), small micronomincin (micronomicin: MCR), isepamicin (is printed amicin: ISP), arbekacin Stars (arbekacin = ABK) and other aminoglycoside antibiotics; erythromycin (erythromycin: EM), spiramycin (spiramycin: SPM), roxithromycin (roxithromycin: RXM), azithromycin (azithromycin: AZM) , Midecamycin (midecamycin: MDM), klacid neomycin (clarithromycin = CAM) and other macrolide antibiotics; vancomycin (vancomycin: VCM), teicoplanin (teicoplanin = TEIC) and other glycopeptide antibiotics ; polymyxin (colistin = CL) and other polypeptide antibiotics; virginiamycin (virginiamycin), Pristinamycin (pristinamycin) and other streptogramins antibiotics; clindamycin (clindamycin = CLDM) and so on Lim neomycin antibiotics; Cephalexin (cephalexin: CEX), cefazolin (cefazolin: CEZ), cephradine (cefradine: CED), cefadroxil (cefadroxil: CDX), Cefamandole (cefamandole: CMD), cefuroxime (cefuroxime: CXM), cefaclor (cefaclor: CCL), cefotaxime (cefotaxime: CTX), cefsulodin (cefsulodin: CFS), cefoperazone (cefperazone), cefotiam (cefotiam: CTM), cephalosporins ceftriaxone (ceftriaxone: CTRX), Cefmenoxime waning (cefmenoxime: CMX), ceftazidime, (ceftazidime: CAZ), cefazolin B deficiency (ceftiroxime), cephalosporin hydroxybenzyl sulfur yl (cefonicid), cefpiramide (cefpiramide : CPM), cefoperazone - sulbactam (cefoperazone: CPZ / sulbactam: SBT), cefpodoxime (cefpodoxime: CPDX), cefodizime (cefodizime), cefdinir (cefdnir = CFDN), cefetamet ( cefetamet = CEMT), cefpirome (cefpirome: CPR), cefprozil (cefprozil), cephalosporin butene (vii bad 7 7 workers work>) (ceftibufen), cefepime (cef India ime: CFPM) and other Vanguard ADM antibiotics; cefoxitin (cefoxitin = CFX), cefmetazole (cefmetazole: CMZ), cefotetan (cefotetan = CTT) and other cephamycins antibiotics; Latamoxef (latamoxef: LM0X), Flomoxef (flomoxef : FM0X) and other oxygen-cephem antibiotic; a imipenem cilastatin (imipenem: IPM / cilastatin = CS; Tanunda: registered trademark) carbapenem antibiotics; aztreonam (aztreonam = AZT) other single-ring lactam antibiotics; chlorine La ratio (Ioracarbef = LCBF) and other carbon cephem antibiotics; panipenem - betamipron (panipenem: PAPM / betamipron: BP) and other carbapenems; telithromycin (telithromycin: TEL) and other ketolide antibiotics.

[0203] 抗癌剂是用于治疗或预防癌症的药品。 [0203] anti-cancer agent for the treatment or prevention of cancer drugs. 其可采用公知的抗癌剂。 It may be a known anti-cancer agents. 具体而言，包括0K-432(商品名为溶链菌）等抗癌溶链菌制剂；云芝多糖K、蘑菇多糖、裂殖菌多糖、西索菲兰等抗癌多糖体；丝裂霉素C (商品名为丝裂霉素等）、放射菌素D (商品名为可美净）、盐酸博莱霉素（商品名为博莱霉素）、硫酸博莱霉素（商品名为博莱霉素-S)、盐酸道诺霉素（商品名为道诺霉素）、盐酸亚德里亚霉素（商品名为阿霉素）、新制癌菌素（商品名为新制癌菌素）、盐酸阿柔比星（商品名为阿克拉霉素）、盐酸表柔比星（商品名为表柔比星）等抗癌抗生素；长春碱这样的有丝分裂抑制剂；顺二氯二氨钼、碳钼、环磷酰胺这样的烷化剂；如5-氟尿嘧啶、阿糖胞苷和羟基脲（hydroxyurea)、N-{5_[N_(3，4- 二氢-2-甲基-4-氧代喹唑啉-6-基甲基）-N-甲氨基]-2-噻吩甲酰}-L-谷氨酸这样的抗代谢剂；亚德里亚霉素和博来霉素这样的抗癌抗生素；如天门冬酰胺酶这样的酶；依托泊苷这样的拓朴异构酶抑制剂；干扰素这样的生物反应修饰剂；“NOLVADEX”（三苯氧胺）这样的抗雌激素；“CAS0DEX” 这样的抗雌激素物质；氟尿嘧啶、喃氟啶、替加氟-尿嘧啶和甲氨蝶呤这样的抗代谢剂；长春新碱这样的植物碱基；丝裂霉素C、放射菌素D、盐酸博莱霉素、硫酸博莱霉素、盐酸道诺霉素、盐酸亚德里亚霉素、新制癌菌素、盐酸阿柔比星、阿克拉霉素、盐酸表柔比星这样的抗癌抗生素；环三磷嗪-钼络合物复合体（cyclotriphosphazene-platinum complex)、顺钼-钼络合物复合体等钼络合物。 Specifically, including 0K-432 (trade name picibanil) and other anti-cancer agents picibanil; krestin K, lentinan, schizophyllan polysaccharides, Cecil Filan and other anti-cancer polysaccharides; mitomycin Su C (trade name mitomycin), actinomycin D (trade name can be beautiful net), bleomycin hydrochloride (trade name bleomycin), bleomycin sulfate (tradename bleomycin -S), daunorubicin hydrochloride (trade name daunorubicin), doxorubicin hydrochloride (trade name Adriamycin), neocarcinostatin (trade name neocarcinostatin ), hydrochloric acid aclarubicin (trade name Aclacinomycin), epirubicin hydrochloride (trade name epirubicin) and other anti-cancer antibiotic; vinblastine such a mitotic inhibitor; cis dichlorodiamine molybdenum carbon molybdenum, alkylating agents such cyclophosphamide; such as 5-fluorouracil, cytarabine and hydroxyurea (hydroxyurea), N- {5_ [N_ (3,4- dihydro-2-methyl-4- oxo-quinoline-6-yl-methyl) -N- methylamino] -2-thenoyl} -L- glutamate such antimetabolites; adriamycin and bleomycin such cancer As such enzyme asparaginase;; antibiotic topoisomerase inhibitors such as etoposide; this biological response modifiers interferon; "NOLVADEX" (tamoxifen) such as anti-estrogen; "CAS0DEX" anti-estrogens such Hormone substances; fluorouracil, tegafur, tegafur - uracil and antimetabolites such as methotrexate; vincristine base such plants; mitomycin C, actinomycin D, bleomycin hydrochloride Su, bleomycin sulfate, daunorubicin hydrochloride, doxorubicin hydrochloride, neocarcinostatin hydrochloride aclarubicin, aclacinomycin, epirubicin hydrochloride such anticancer antibiotic; cyclotriphosphazene phosphagen-- complex molybdenum complex (cyclotriphosphazene-platinum complex), along molybdenum - molybdenum complex molybdenum complex and other complexes.

[0204] 由于人们希望本发明的骨填充材能促进其在生物体内对骨的替代，所以可将具有特定的多肽或基因的药剂浸渍在骨填充材中或涂敷在其表面上。 [0204] Since it is desirable Caineng bone filler of the present invention to promote an alternative to bone in vivo, it may be impregnated with a specific agent or a polypeptide gene in a bone filler or coated on the surface thereof. 这种多肽或基因包括碱性成纤维细胞生长因子（bFGF)；血小板衍生生长因子（PDGF)；胰岛素、胰岛素样生长因子(IGF)；肝细胞生长因子（HGF)；胶质细胞源性神经营养因子（GDNF)；神经营养因子（NF)； 激素；细胞因子；骨形成因子（BMP)；转化生长因子（TGF)；血管内皮细胞生长因子（VGEF)。 Such polypeptides or gene include basic fibroblast growth factor (bFGF); platelet-derived growth factor (PDGF); insulin, insulin-like growth factor (IGF); hepatocyte growth factor (HGF); glial cell line-derived neurotrophic factor (GDNF); neurotrophic factor (NF); hormones; cytokines; bone morphogenetic factor (BMP); transforming growth factor (TGF); vascular endothelial growth factor (VGEF). 其中，优选促进血管新生和/或骨形成的生长因子。 Among them, promote angiogenesis and / or bone formation growth factors. 这种生长因子例如包括骨形成因子(BMP)、骨生长因子（BGF)、血管内皮细胞生长因子（VGEF)和转化生长因子（TGF)。 Such growth factors include, for example bone morphogenetic factor (BMP), bone growth factors (BGF), vascular endothelial growth factor (VGEF) and transforming growth factor (TGF). 具体而言，如日本发明专利公报特许3713^0号所公开的钙结合蛋白基因。 Specifically, as described in Japanese Patent Publication Laid-3713 ^ Open No. 0 calcium binding protein gene. 骨填充材中可含有有效量的用于基因治疗的基因。 The bone filling material containing the gene for gene therapy can be an effective amount. 基因可在其自身的状态下（裸露状态）以胶束状包含在骨填充材中，或者以转换成病毒载体等公知载体的基因重组载体形式包含在骨填充材中。 Genes can be in its own state (bare state) to form micelles contained in the bone filling material, or to be converted into the form of a recombinant vector or other known viral vector gene carriers included in the bone filling material. 药剂也可以是公知的基因抗体。 The agent may be a known genetic antibody.

[0205] 可按照常规方法根据公知的碱基顺序来调整基因。 [0205] in accordance with conventional methods known to adjust the base sequence genes. 例如，按照如下方法来调整靶向基因的cDNA ：即，先从造骨细胞中提取RNA，并根据公知的碱基顺序合成引物（引子），然后用PCR法进行克隆，这样，则可调整靶向基因的cDNA。 For example, in the following manner to adjust the target gene cDNA: namely, starting osteoblasts extracted RNA, and based on a known base sequence of the synthetic primer (primer) and then cloned by PCR method, so that you can adjust the target cDNA gene to. 此外，也可采用市售的基因。 In addition, a commercially available gene can also be used.

[0206] 对于本发明的骨填充材，其优选实施方式为，所述骨填充材中含有稳定剂。 [0206] For bone filling material of the present invention, a preferred embodiment thereof, the bone filling material contains a stabilizer. 作为稳定剂，可采用聚合物等中所用的公知稳定剂，也可此药学中所允许的稳定剂。 As a stabilizer, the polymer can be used like known stabilizers may also be allowed in the pharmaceutical stabilizers. 本发明的骨填充材大部分能在生物体内长时间保持其强度。 Bone filler of the present invention is capable of long time to maintain the majority of its strength in the living body. 但由于生物体存在蛋白酶等酶，所以假定骨填充材会在早期被分解。 However, due to the presence of the organism protease enzyme, it is assumed that the bone filling material is decomposed at an early stage. 因此，本发明的优选实施方式是，稳定剂中含有蛋白酶抑制剂等抑制剂。 Accordingly, a preferred embodiment of the present invention is a stabilizer containing a protease inhibitor inhibitor. 这种抑制剂可采用公知的酶抑制剂。 Such inhibitors may be known inhibitors. 具体而言，蛋白酶抑制剂可以是如下物质中的任意一种或两种以上。 Specifically, the following materials protease inhibitor may be any one or two or more kinds. 即，4-(2-氨乙基）苯磺酰氟；抑肽酶（Aprotinin)；贝他茵（Bestain)； 钙蛋白酶抑制剂I ；钙蛋白酶抑制剂II ；胰凝乳蛋白酶抑制剂（Chymostain) ；3，4_ 二氯异香豆素（3，4-Dichloroisocoumarin) ；E-64 ；EDTA ；EGTA ；乳胞素(Lactacystin)；亮肽素(Leupeptin) ；MG-115，MG-132 ；胃蛋白酶抑制剂（P^stainA)；苯基甲磺酰氟；蛋白酶体抑制剂I ；对甲苯磺酰-L-赖氨酸氯甲基酮；对甲苯磺酰-L-苯丙氨酸氯甲基酮；或酪氨酸酶抑制剂。 That is, 4- (2-aminoethyl) benzene sulfonyl fluoride; aprotinin (Aprotinin); beta Inn (Bestain); calpain inhibitor I; calpain inhibitor II; chymostatin (Chymostain ); 3,4_ dichloroisonicotinic coumarin (3,4-Dichloroisocoumarin); E-64; EDTA; EGTA; lactacystin (Lactacystin); leupeptin (Leupeptin); MG-115, MG-132; pepsin inhibitor (P ^ stainA); phenylmethylsulfonyl fluoride; proteasome inhibitor I; -L- tosyl-lysine chloromethyl ketone; tosyl-phenylalanine chloromethyl -L- ketone; or tyrosinase inhibitors. 这些蛋白酶抑制剂是市售抑制剂，其抑制浓度也是公知的。 These protease inhibitors are commercially available inhibitors, which are also known inhibitory concentration. 对于由本发明的骨填充材所形成的化合物，其优选实施方式为，该化合物在生物体内长时间保持其强度，且使药剂具缓释性。 For the compound represented by the bone filling material of the present invention is formed, a preferred embodiment thereof, the compound in the living body to maintain its strength for a long time, and a sustained release of the medicine. 因此，本发明的骨填充材，优选为所述蛋白酶抑制剂的含量为其1次给药量的2倍〜100倍，更优选为1次给药量的2倍〜50倍。 Thus, the bone filling material of the present invention, preferably the content of the protease inhibitor for a second dose of ~ 100-fold 2-fold, and more preferably 1 ~ 50 times the dose of 2 times. 蛋白酶抑制剂的具体含量可根据所用蛋白酶抑制剂的种类的不同而不同，但优选含有能有效发挥作用的量（有效量），通常情况下，每Ig骨填充材中含有0. 1 μ g〜0. 5mg的蛋白酶抑制剂；也可含有1 μ g〜0. Img的蛋白酶抑制剂；还可含有10μ g〜0. Img的蛋白酶抑制剂；蛋白酶抑制剂具体的加入量大致与所加骨填充材的位置的容积成比例地变化。 Protease inhibitors may be based on the specific content of the kind of protease inhibitors used differs, but the amount preferably contains effective functioning (effective amount), typically, each Ig bone filling material containing 0. 1 μ g~ Protease inhibitors 0. 5mg; that may contain 1 μ g~0 Img protease inhibitors;. may contain 10μ g~0 Img protease inhibitor; Protease inhibitors specific amount is substantially filled with the applied bone the volume of material in proportion to the change in position.

[0207] 本发明中，还优选将粘合性给予剂浸渍在骨填充材（或烧结工序中获得的烧结体）内，或将其涂敷在制造的骨填充材（或烧结工序中获得的烧结体）上。 [0207] The present invention is also preferable that the adhesive agent is impregnated in a given bone filler (obtained in the sintering step or sintered body) within, or to the manufacture of coated bone filler (obtained in the sintering step, or sintered body) on. 在粘合性给予剂是耐热性的粘合性给予剂情况下，也可让粘合性给予剂与原料粉末混合，从而获得原料粉末中混合有粘合性给予剂的骨填充材（此时，不仅骨填充材的表面上具有粘合性给予剂， 而且表面被骨置换而新出现的表面上也具有粘合性给予剂，所以可保持粘结性）。 Adhesion imparting agent in heat-resistant adhesion is given to the case of agents, can also be mixed so that the adhesive agent is administered with the raw material powder to obtain a mixed raw material powder in the adhesive agent is administered bone filler (this having adhesiveness on, not only the surface of the bone filler administered agent, and replaced on the bone surface and emerging surfaces having adhesiveness imparting agent, it is possible to maintain adhesion). 此外，粘合性给予剂也可以粉末状态散布在成型体或烧结体的表面上。 Furthermore, adhesiveness-imparting agent may be dispersed in a powder state on the surface of the molded body or a sintered body. 通过混合很多骨填充材和粉末状粘合性给予剂并适当搅拌来混合粉末，可让粘合性给予剂附着在骨填充材的表面上。 Many bone filler by mixing and powdered adhesiveness-imparting agent and a suitable powder mixed with stirring, allowing the adhesive agent attached to the surface to give bone filler. 可让粘合性给予剂与所述药剂一起浸渍在骨填充材（或烧结工序中获得的烧结体）内，或涂敷在骨填充材（或烧结工序中获得的烧结体）上。 Allow adhesion imparting agent is impregnated with the agent (or a sintered body obtained by sintering step) together in the bone filler, bone filler, or coated (obtained in the sintering step or a sintered body) on. 也可只让粘合性给予剂浸渍在骨填充材（或烧结工序中获得的烧结体）内，或涂敷在骨填充材（或烧结工序中获得的烧结体） 上。 May also be administered only allows adhesiveness (or a sintered body obtained in the sintering step) impregnating agent in the bone filler, the bone filler or coating (or sintered sintered body obtained in the step) on. 粘合性给予剂是用于提高骨填充材之间粘合凝聚性的作用剂，其优选是这样一种物质， 即，其在粘合性给予剂独立存在时不具有较强的粘合性，但当在生物体内与体内细胞等接触时粘合凝聚性则会变强。 Adhesion imparting agent is used to improve the adhesion between the bone filler cohesive agent, which is preferably a substance, i.e., it does not give an independent agent with strong adhesion to the presence of the adhesive , but when cells in vivo and in vivo exposure of the bond becomes stronger cohesion. 具体而言，粘合性给予剂可以是凝血酶。 Specifically, the adhesive agent may be administered thrombin. 凝血酶是容易使血液凝固的酶中的一种。 Thrombin is easy to make blood clotting enzymes in one. 凝血酶在生物体内的作用是生成纤维蛋白，纤维蛋白是使血液凝固的血液凝固物质。 Thrombin is generated in vivo fibrin, fibrin is blood clotting blood clotting substances. 通过凝血酶所生成的纤维蛋白，容易使血液凝固。 By thrombin generated fibrin, easy to make blood coagulation. 从而，若以凝血酶作为粘合性给予剂时，则可增强骨填充材表面的粘合凝聚性。 Thus, when the terms of thrombin as an adhesive imparting agent, can enhance adhesion surface of the bone filling material cohesion. 这样，可将骨填充材彼此固定，提高骨填充材整体的强度。 In this way, the bone filling material fixed to each other, to improve the overall strength of the bone filler. 可以按照与上述药剂相同的方式将与上述药剂等量的凝血酶浸渍在在骨填充材（或烧结工序中获得的烧结体）内，或将其涂敷在骨填充材（或烧结工序中获得的烧结体）上。 May be impregnated with thrombin equivalent amount of said drug in (or a sintered body obtained in the sintering step) in the bone filler, or it is applied in bone filler (or sintering step according to the same manner as the above-described medicine The sintered body) on.

[0208] “其盐”是指上述化合物的盐，尤其是指药学中所允许的所述化合物的盐。 [0208] "Salt thereof" refers to salts of the above compounds, in particular, refers to pharmaceutically allowable salts of the compounds. 本说明书中的“药学中所允许的”的意思是指不会对接受者有害。 The term "pharmaceutically allowed" is meant not harmful to the recipient. 本发明中的多磷酸可通过常规的方法制成多磷酸盐。 Polyphosphoric acid of the present invention can be made by conventional methods polyphosphates. 该盐例如可以是：钠盐、钾盐、锂盐等碱金属盐；钙盐、镁盐等碱土类金属盐；铝盐、铁盐、锌盐、铜盐、镍盐、钴盐等金属盐；铵盐等无机盐；叔辛基胺盐(t-octylamine salt)、二苄基胺盐、吗啉盐、葡萄糖胺盐、苯基甘氨酸烷基酯盐、乙二胺盐、 N-甲基葡萄糖胺盐、胍盐、二乙胺盐、三乙胺盐、二环己基胺盐、N, N' - 二苄乙二胺盐、氯普鲁卡因盐、普鲁卡因盐、二乙醇胺盐、N-苄基-N-苯乙胺盐、哌嗪盐、四甲基铵盐、三（羟甲基）氨基甲烷盐等有机盐等的胺盐。 The salt may be, for example: sodium, potassium, lithium salts, alkali metal salts; calcium, magnesium and other alkaline earth metal salts; aluminum salts, iron salts, zinc salts, copper salts, nickel salts, cobalt salts and the like salts ; inorganic salts such as ammonium salts; tertiary octyl amine salt of (t-octylamine salt), dibenzylamine salts, morpholine salts, glucosamine salts, phenylglycine alkyl ester salts, ethylenediamine salts, N- methyl- glucamine salt, guanidine salt, diethylamine salt, triethylamine salt, dicyclohexylamine salt, N, N '- dibenzyl ethylenediamine salts, chloroprocaine salts, procaine salts, diethanolamine salt, N- -N- benzyl phenethylamine salts, piperazine salts, tetramethylammonium salt, tris (hydroxymethyl) aminomethane salt and organic salts such as amine salts. 其中，多磷酸盐优选碱金属盐，更优选钠盐。 Wherein, preferably an alkali metal polyphosphate, more preferably sodium salts. 本说明书中，“其盐”不仅包括无水盐，还包括含水盐。 The term "salt" includes not only anhydrous salt, including salt water. 所述盐通过在如生物体等内电离而与上述化合物起到相同的作用。 The salt in the ionization by such organisms like the above-mentioned compounds play the same role.

[0209] “其溶剂化物”是指所述化合物的溶剂化物。 [0209] "solvates" refers to solvates of said compounds. 溶剂化物包括水合物。 Solvates include hydrates. 当将本发明中的药剂放置在大气中或使其再结晶时，该药剂则会吸收水分而带上附着水或变成水合物。 When the present invention, an agent placed it in the air or when recrystallized, the agent will absorb moisture and bring the attached water or become a hydrate. 以这种方式形成的溶剂化物也包括在“其溶剂化物”中。 Solvates formed in this manner are also included in "its solvate" in. 这些溶剂化物通过在生物体等内电离而与上述化合物起到相同的作用。 These solvates are ionized by an organism like in the above-mentioned compounds play the same role.

[0210] 3-4.骨填充材的使用方法 [0210] 3-4. Use a bone filler

[0211] 按照如上方式所制得的骨填充材例如用于外科或整形外科在治疗时填充骨缺损部分。 [0211] The above manner obtained bone filler such as for surgical or orthopedic surgery in the treatment of bone defects filling part. 如图1所示，对于骨缺损部分上填充有本发明的骨填充材的患者，由于本发明的骨填充材与骨缺损部分的形状一致，所以当填充骨填充材填充在骨缺损部分上时，可保持填充部分的强度。 As shown, for the patients with bone defect partially filled with a bone filler of the present invention, the bone filler shape consistent with the bone defect part of the present invention, so when filled with bone filler filled in the bone defect part 1 , filling part of strength can be maintained. 此外，因骨填充材可迅速替代骨组织，所以骨组织能尽快再生。 In addition, because the bone filling material can quickly replace bone tissue, bone tissue can be reproduced so quickly. 即，本发明还可提供一种采用如上制得的骨填充材来治疗骨缺损患者的治疗方法。 Specifically, the present invention also provides a use of the above-prepared to treat bone filler treatment of patients with bone defects.

[0212] 4.骨填充材的制造方法 [0212] The method for producing a bone filler

[0213] 本发明还涉及一种骨填充材的制造方法，该方法包括如下工序。 [0213] The present invention further relates to a method for producing a bone filler, the method comprising the following steps. 即，制造骨模型的骨模型制造工序；造型材料设置工序：对所述骨模型制造工序中获得的骨模型设置造型材料；骨填充材制造工序：根据所述造型材料设置工序中设置在骨模型上的造型材料，制造骨填充材。 That is, producing a bone model of bone model producing step; molding material is disposed step: set the shape of the bone model material from the bone model producing step; the bone filler producing step: molding material is arranged according to the process set in bone model On the modeling material, producing a bone filling material. 造型材料设置工序优选对所述骨模型制造工序中获得的骨模型设置造型材料，以修正骨模型的非对称性。 Setting bone model modeling material modeling material is placed on the bone model process is preferably obtained in the manufacturing process to correct the asymmetry of the bone model. 这样，可获得能修正骨变形的骨填充材。 This can be corrected bone filler obtained bone deformation. 对于该骨填充材的制造方法，其优选实施方式为，所述骨模型制造工序中获得的骨模型是描绘有等高线或网格图案的骨模型。 The method for producing a bone filler, a preferred embodiment thereof, the bone model obtained in the bone model producing step has contour lines that depict a pattern or grid bone model. 对于上述任意一种骨填充材的制造方法，其优选实施方式为，所述造型材料设置工序中所采用的造型材料是X射线透过率、红外线透过率或紫外线透过率与所述骨模型不同的造型材料。 For any of the above-described method for producing a bone filler, a preferred embodiment thereof, the molding material forming material setting step is used in X-ray transmittance, ultraviolet transmittance and infrared transmittance, or the bone models of different shapes materials. 对于上述任意一种骨填充材的制造方法，其优选实施方式为，骨模型是骨缺损患者、骨变形患者或美容整形患者的骨模型。 For any of the above method for producing a bone filling material, which is a preferred embodiment of the bone model is a bone defect in patients with bone model of bone deformation cosmetic surgery patients or patients. 按照本发明的骨填充材的制造方法所获得骨填充材可修正骨变形或美化骨骼，所以可有效地应用在对骨变形的治疗或美容整形等方面。 The manufacturing method of bone filling material of the present invention obtained bone filler may be amended or landscaping skeleton bone deformation, it can be effectively used in the treatment or cosmetic surgery to bone deformation and so on.

[0214] 5.石膏托的制造方法 [0214] 5. The method of manufacturing of plaster

[0215] 本发明还涉及一种骨填充材和石膏托的制造方法，该方法包括如下工序。 [0215] The present invention also relates to a method for producing a bone filler and plaster, the method comprising the steps of. 即，骨数字信息获得工序：对患者的特定部位拍照，获得所述患者特定部位的骨的数字信息，该信息中包括多个骨的剖视图；骨模型制造工序：根据在所述骨数字信息获得工序中获得的具有多个骨的剖视图的数字信息，制造所述患者特定部位的骨模型；造型材料设置工序：对所述骨模型制造工序中制造的骨模型设置骨填充用的造型材料和石膏托形成用的造型材料， 该石膏形成用的造型材料的材料与所述骨填充用的造型材料的材料不同；造型材料数字信息获得工序：对在所述造型材料设置工序中设置有造型材料的骨模型拍照，获得造型材料的数字信息；骨填充材和石膏托制造工序：根据在所述造型材料数字信息获得工序中获得的造型材料的数字信息，制造骨填充材和石膏托。 I.e., bone digital information obtaining step of: photographing a specific part of the patient, obtaining the patient's bone specific portion of digital information, a plurality of cross-sectional view of the information included in the bone; bone model producing step: based on the obtained bone digital information in the the digital information having a cross-sectional view of the step of obtaining a plurality of the bone, producing patient specific part of the bone model; step molding material is arranged: the bone model produced in the bone model producing step is provided with the shape of the bone filling material and gypsum entrusted with forming a molding material, the material forming the plaster molding material used in the bone-forming material filled with a different material; molding material digital information obtaining step: to set the molding material is provided in the step of molding material bone model pictures, get digital information modeling materials; bone filler and plaster manufacturing processes: according to the molding material digital information obtaining step of obtaining digital information modeling materials, manufacture bone filler and plaster.

[0216] 通过采用上述骨填充材和石膏托的制造方法，可获得适于患者的骨填充材，还可设计能适当支承该骨填充材的石膏托。 [0216] By adopting the above method for producing a bone filler and plaster, and get adapted to the patient's bone filler, it can also be designed to properly support the plaster of the bone filler. 由于石膏托形成用的造型材料中含有与所述骨填充材用的造型形成材料不同的材料，所以在通过CT扫描或MRI等拍照时，可区分出二者的形状。 Since the formation of the plaster molding material contained in the bone filling material is formed by the shape of a different material, so when by CT scan or MRI and other camera, you can distinguish between the two shapes. 具体而言，也采用与所述骨填充材的制造方法相同的方法来制造石膏托。 Specifically, the manufacturing method was also used for bone filling material in the same manner to produce plaster. 此外，石膏托的材料可以是用于石膏托的公知材料，也可以是与骨填充材相同的材料。 In addition, plaster of material may be a known material for the plaster can also be filled with bone material of the same material.

[0217] 本发明还涉及一种石膏托的制造方法，该方法包括如下工序。 [0217] The present invention also relates to a method for producing a plaster, the method comprising the steps of. 即，骨和软组织的数字信息获得工序：对患者的特定部位拍照，获得所述患者特定部位的骨的数字信息，该信息中包括多个骨的剖视图，还获得所述骨周围的软组织的相关数字信息；石膏托制造工序： 根据在所述骨和软组织的数字信息获得工序中获得的具有多个骨和软组织的剖视图的数字信息，制造所述患者特定部位的石膏托。 That is, the digital information obtained bone and soft tissue steps of: photographing a specific region of a patient to obtain a specific part of the patient bone digital information, a cross-sectional view of the information included in a plurality of bone, but also to obtain the relevant soft tissue around the bone digital information; plaster manufacturing process: a cross-sectional view according to the digital information having a plurality of bone and soft tissue in the digital information of the bone and soft tissue obtained in the obtaining step, patient-specific parts of the plaster manufacturing said. 由于是根据所述软组织的数字信息来制造石膏托，所以可制造形状适于患者的定制石膏托。 Because it is based on the digital information of the soft tissue to produce plaster, it is possible to manufacture custom shaped to the patient plaster. 本说明书中的软组织是指生物体内除骨之外的较软的部位，具体而言，是指内脏、肉和皮肤等。 This specification refers to the soft tissue in vivo bone in addition to softer parts, specifically refers to the internal organs, meat and skin. 就本发明的骨填充材和石膏托的制造方法以及石膏托的制造方法而言，可采用前述的骨填充材制造方法的优选实施方式和。 On bone filler and plaster manufacturing method of the present invention and a method for plaster in terms of the foregoing preferred embodiment may be a bone filler and manufacturing method. 具体而言，可按如下方式来设计石膏托，例如，以左右对称的某些部位（如颅骨、下颚部分、上颚部分、四肢或骨盆等）作为对象部位，选择比对应的部位低规定阈值（如5mm)以上的部分， 并模拟该部分上设置有骨填充材时的形状，然后，将石膏托设计成对设置有骨填充材的部分进行覆盖的形状。 Specifically, the following methods can be used to design plaster, for example, in some symmetrical parts (e.g. the skull, jaw portions, the upper jaw portion, limbs or pelvis, etc.) as the target site, the portion corresponding to the low selectivity predetermined threshold value ( As 5mm) above the part, and simulate the shape of a bone filler provided on the portion of the time, and then the plaster designed to be provided with a bone filler form part covered. 这种设计可通过编制一种使计算机按上述方式动作的程序而轻易地实现。 This design through the development of a type of computer program that operates in the above manner and easily realized. 即，由具有软组织信息和对象部位即骨的信息的计算机读取存储器所存储的程序，并执行规定的运算，由此获得石膏托的设计数据。 That is, the computer having soft tissue information and the object that is part of the bone of the information stored in the memory is read, and executing a predetermined operation, whereby plaster design data. 此外，也可将石膏托设计成仅仅是让软组织部分高出规定值（如Icm)的形状。 Moreover, the plaster can also be designed as simply part of the soft tissue above the predetermined value (such as Icm) shape.

[0218] 6.外观模型和其制造方法 [0218] 6. The appearance model and its manufacturing method

37[0219] 本发明还涉及一种描绘有等高线或网格图案的身体某部位的外观模型。 37 [0219] The present invention also relates to a method has contour lines or grid patterns of physical appearance model of a site. 由于外观模型上描绘有等高线或网格图案，所以可客观地确定特定部位的变形。 Since drawing contour lines or grid patterns have the appearance model, it is possible to objectively determine the specific portion of the deformation. 尤其是在比较手术前后的外观模型后，可客观地确定手术进行了何种程度的变化。 Especially after the appearance of the model compare before and after surgery, surgery can objectively determine what degree of change.

[0220] 上述外观模型的优选实施方式为，所述外观模型是再现了患者特定部位的外表的模型。 [0220] preferred embodiment of the above-described appearance model, the appearance model is a reproduction of the outer portion of the patient specific model. 患者特定部位可包括前面所述的部位等，具体而言，如面部、头、四肢、胸、下腹部或腰寸。 Specific parts of the patient may comprise the aforementioned parts, etc., specifically, such as the face, head, limbs, chest, abdomen, or lower back inches.

[0221] 对于上述外观模型，其优选实施方式为包括如下工序。 [0221] For the above-described appearance model, which is the preferred embodiment comprises the steps of. 即，剖视图数字信息获得工序：对患者的特定部位拍照，获得所述特定部位的剖视图的数字信息，该信息中包括所述患者特定部位的多个骨和软组织的剖视图；描绘信息获得工序：根据所述剖视图信息获得工序中获得的具有多个骨和软组织的剖视图的数字信息，计算所述特定部位的表面各部位距基准面的高度，或所述特定部位的表面各部位和基准点在平面上的错位量；外观模型制造工序：通过快速原型法制造所述患者特定部位的外观模型，并根据所述描绘信息获得工序中获得的高度或平面上的错位量，描绘等高线或网格图案。 I.e., cross-sectional view digital information obtaining step: a specific part of the patient's camera, obtaining the specific part of digital information a cross-sectional view, the information includes a plurality of bone and a cross-sectional view of the patient-specific portion of the soft tissue; drawing information obtaining step: According to The cross-sectional view digital information obtaining information sectional view of pluralities of bones and soft tissues obtained in the step of having to calculate the specific portion of the surface of each portion of the height from the reference plane, or a specific part of the surface of each portion and the reference point in the plane on the displacement amount; appearance model producing step: the rapid prototype method by producing patient specific parts appearance model, and based on the drawing information obtaining height or plane displacement amount obtained in the step of drawing contour lines or grid pattern. 通过这种制造方法，可恰当地制造外观模型。 In this manufacturing method, an appearance model can be properly produced. 患者特定部位是填充骨填充材的部位，如因事故等而缺损的部位、因骨变形疾病等而发生骨骼变形的部位等。 Patients with a specific site is the site filled with bone filler, as a result of accidents and defects in parts, due to bone deformation occurring disease of bone deformation and other parts. 本发明中，由于既可获得手术前的外观模型，又可获得手术后的外观模型，所以可显示出外科手术等手术前后外观发生了何种程度的变化。 The present invention, since the appearance of the model can get before surgery, and the appearance of the model obtained after surgery, it is possible to show the extent to which changes in appearance before and after surgery, such as surgery occurred. 外观模型可采用与前述骨模型相同的材料和相同的方式制得。 Appearance model can be used with the previous bone model of the same material and the same way the system. 即，本说明书中，可采用前述的制造骨模型的装置和方法来制造外观模型。 That is, the present specification, the foregoing apparatus and method can be used for producing a bone model to create the appearance of models. 可根据上述记载进行适当变更后加以运用，以避免重 After use of them may be appropriately changed in accordance with the above description, in order to avoid heavy

Μ. ο Μ. Ο

[0222] 7.赝复体（印ithesis)的制造方法或赝复体制造用铸模的制造方法 [0222] 7. The prosthesis (India ithesis) manufacturing method or prosthesis fabrication method for producing a mold

[0223] 本发明还涉及一种赝复体的制造方法，该方法包括如下工序。 [0223] The present invention also relates to a method for producing a complex body of a pseudo, the method comprising the steps of. 即，剖视图数字信息获得工序：对患者的特定部位拍照，获得所述特定部位的剖视图的数字信息，该信息中包括所述患者特定部位的多个骨和软组织的剖视图；三维数字图像获得工序：根据在所述剖视图数字信息获得工序中获得的具有多个骨和软组织的剖视图的数字信息，获得所述特定部位的三维数字图像；赝复体图像数据获得工序：根据在所述三维数字图像获得工序中获得的所述特定部位的三维数字图像，获得赝复体图像数据；赝复体制造工序：根据所述赝复体图像数据获得工序中获得的赝复体图像数据，通过快速原型法来制造赝复体。 I.e., cross-sectional view digital information obtaining step: the digital information cross-sectional view of a particular portion of the patient's photographs, obtaining the specific part of the information included in the sectional view of pluralities of bones and soft tissues of the patient-specific portion; three-dimensional digital image obtaining step of: According to a cross-sectional view of the digital information with a plurality of bone and soft tissue in the cross-sectional view digital information obtaining step, there was obtained the specific part of the three-dimensional digital image; prosthesis image data obtaining step: According to the three-dimensional digital images obtained three-dimensional digital image of the specific portion of the process, there was obtained image data prosthesis; prosthesis manufacturing process: obtaining prostheses image data obtained in the step of the prosthesis according to the image data, by the rapid prototype method manufacturing prosthesis. 该赝复体的制造方法可适当采用前述各制造方法中所说明的技术。 The method of manufacturing the prosthesis can be appropriately used technology foregoing manufacturing method described. 赝复体是指假体或假体装置， 主要是指安装在身体表面上的人造物。 Prostheses refers to the prosthesis or prosthetic devices, mainly refers mounted on the body surface creation. 本发明中，为了根据特定部位的三维数字图像获得赝复体图像数据，采用了如下方式：例如，先获得面部、颚部、眼睛、四肢、骨盆及其周围的软组织等特定部位的左右对称部位的数字图像，并对获得的左右对称部位的信息进行仿射变换，使其左右对称，然后，让该数字信息与安装有赝复体的对象部位的数字信息重叠，求得差异部分，由此获得赝复体图像。 The present invention, in order to obtain prostheses image data according to the three-dimensional digital image of a particular site, using the following methods: for example, to obtain specific parts of the face, jaw, eyes, limbs, pelvis and surrounding soft tissue such as symmetrical parts digital image, and get information about symmetric parts affine transformation to symmetrical, then, let the digital information and mounted target region prosthesis overlapping digital information, obtained by the difference portion, thereby get prosthesis image. 该方法可用在本说明书中的其他方法中。 The method used in this specification other methods. 此外，也可由外科医生根据患者特定部位的数字信息，通过指针设备等输入赝复体图像，由此来获得赝复体图像数据。 In addition, by the surgeon based on the patient specific parts of the digital information, input prosthesis image by a pointing device, etc., thereby obtaining prostheses image data. 此外，可按照前述的快速原型法等计算机辅助图像形成方法，用获得的赝复体图像数据制造赝复体造型。 In addition, in accordance with the aforementioned method for forming rapid prototyping and other computer-aided image, obtained with the prosthesis manufacturing prosthesis image data modeling. 尤其是，可采用如下方式来获得具有颜色信息的赝复体。 In particular, it can be a way to get the prosthesis having color information. 即，先通过MRI等获得对象部位的外表部位信息和颜色信息，在通过快速原型法制造赝复体造型时，关联存储外表部位信息和该部位的颜色信息，当制造该外表部位时，根据与外表部位信息关联存储的颜色信息，涂敷墨等着色剂，由此可制造反映出颜色信息的赝复体。 That is, first obtained by MRI and other parts of the outer portion of the object information and color information at the time of manufacture by rapid prototyping method prosthesis shape, stored in association outer parts of the information and the parts of the color information, when manufacturing the appearance of the site, according to the outer parts of the information associated with the stored color information, such as ink coating colorant, thereby reflecting the color information of manufacturing prosthesis. 此外，也 In addition,

38可根据患者特定部位的外表颜色被均勻后的信息等，设定按照快速原型法制造的赝复体图像的基本颜色，由此来获得反映出颜色信息的赝复体。 38 According to specific parts of the patient's skin color is uniform after the information set prostheses pictures by rapid prototyping manufacturing of basic colors, thereby reflecting the color information obtained prosthesis.

[0224] 本发明还涉及一种赝复体制造用铸模的制造方法，该方法包括如下工序。 [0224] The present invention also relates to a prosthesis fabrication method for producing a mold, the method comprising the steps of. S卩，剖视图数字信息获得工序：对患者的特定部位拍照，获得所述特定部位的剖视图的数字信息，该数字信息包括所述患者特定部位的多个骨和软组织的剖视图；三维数字图像获得工序：根据在所述剖视图数字信息获得工序中获得的具有多个骨和软组织的剖视图的数字信息， 获得所述特定部位的三维数字图像；外观模型制造工序：根据在所述三维数字图像获得工序中获得的所述特定部位的三维数字图像，制造所述特定部位的外观模型；造型材料设置工序：对所述外观模型制造工序中获得的外观模型设置造型材料；造型材料数字信息获得工序：对在所述造型材料设置工序中设置有造型材料的外观模型拍照，获得造型材料的数字信息；铸模信息获得工序：根据在所述造型材料数字信息获得工序中获得的造型材料的数字信息，获得用于制造赝复体的铸模的数字数据；铸模制造工序：根据所述铸模信息获得工序中获得的信息制造铸模。 S Jie, cross-sectional view digital information obtaining step: a specific part of the patient's photographs, to obtain the digital information cross-sectional view of the specific portion of the digital information includes patient specific part cross-sectional view of pluralities of bones and soft tissues of the; three-dimensional digital image obtaining step : according to a cross-sectional view of a plurality of digital information of bones and soft tissue in the cross-sectional view having digital information obtaining step of obtaining, the specific site to obtain a three-dimensional digital image; appearance model producing step: based on the three-dimensional digital image obtained in step three-dimensional digital image of the specific portion of the gain, manufacturing the specific part of the appearance of the model; modeling material is disposed step: the appearance of the model set up the appearance model modeling material obtained in the manufacturing process; molding material digital information obtaining step: pair wherein the step of forming material disposed camera provided with an appearance model molding material, the molding material to obtain the digital information; mold information obtaining step: The digital information obtained in the forming material digital information obtaining step of molding material used to obtain manufacturing mold prosthesis digital data; mold manufacturing process: manufacturing the mold according to information obtained information obtaining step mold. 本发明中，例如，在左右对称部位的一部分缺损等情况下， 根据剩下的部位来推定缺损部位的形状，从而本发明可提供一种对称性好的赝复体制造方法或赝复体用铸模的制造方法。 The present invention, for example, in the part of the symmetrical parts of the defects, etc., according to estimates the shape of the remaining defect parts, so the present invention can provide a good symmetry method for manufacturing prosthesis or prosthesis use The method of manufacturing mold. 此外，本发明是通过CT扫描等获得特定部位的形状信息， 再根据该形状信息用计算机来设计赝复体，从而患者不需要直接与印模材料等接触，从而本发明可提供一种微创的赝复体制造方法或赝复体制造用铸模的制造方法。 Further, the present invention is obtained by a specific part shape information CT scan, and then based on the shape information using a computer to design prosthesis, so that the patient does not require direct contact with the impression material, whereby the present invention can provide a minimally invasive The method of manufacturing a prosthesis or prosthesis fabrication method for producing a mold. 对于按上述方式获得的赝复体制造用铸模，优选按如下方式获得：例如，在铸模中放入硅酮蜡而制造赝复体基材，外科医生对该赝复体基材进行雕刻等细小的调整，优选对其上色。 For prostheses obtained in the manner described above for producing a mold, preferably obtained as follows: for example, placed in the mold manufacturing silicone wax prosthesis base, surgeon of the prosthesis base for carving and other small adjustment, it is preferably colored. 在按上述方式获得赝复体后，可通过矫形外科等中所用的公知手术方法安装赝复体。 After the above-described manner to obtain prostheses, prostheses can be installed by a well-known orthopedic surgery and other surgical methods used in.

[0225] 实施例1 [0225] Example 1

[0226] 下面用实施例具体说明本发明。 [0226] The following examples illustrate the present invention. 本发明不限于下述实施例，可对本说明书中所公开的内容进行适当调整而进行实施。 The present invention is not limited to the following examples may be disclosed in the specification of the content and appropriate adjustments were implemented. 图2是本实施例中各步骤的示意图。 Figure 2 is a schematic diagram of the various steps of the implementation. S卩，本实施例中， 通过制造用于修正骨变形患者的骨变形的骨填充材，并将该骨填充材植入骨变形患者体内，来矫正骨变形。 S Jie, in this embodiment, by making the bone for the bone filling material deformation correcting deformation of the patient's bone, the bone filler and bone deformation implanted patient, to correct bone deformation. 如图2所示，本实施例中的骨填充材的制造方法是用CT拍摄患者的颅骨(前半部分）而将其数字化的方法。 2, the method of manufacturing the present bone filler embodiments with CT photographing skull (front half portion) and its method of digitizing a patient. 图3是表示通过CT拍摄到的CT图像的图，以此替代附图。 Figure 3 shows a CT captured through the CT image in FIG., In place of the accompanying drawings. 图3(a)是脸颊部分的CT图像，图3(b)是下颚部分的CT图像。 Figure 3 (a) is part of the cheek CT image, Figure 3 (b) is a CT image jaw portion. 如图3(a)和图3(b)所示，拍摄CT图像的患者的骨骼并不左右对称，而出现了变形。 FIG. 3 (a) and FIG. 3 (b), the CT image photographing the patient's bone is not symmetrical, but there has been deformed. 根据该CT图像，通过计算机来获得患者颅骨的三维数字图像，并按照快速原型法来制造骨模型（1)。 According to the CT images to obtain patient's skull three-dimensional digital images via computer and follow the rapid prototyping method for producing a bone model (1). 图4(a)表示获得的石膏模型（骨模型），图4(b)表示骨模型的侧视图，图4(c)表示描绘有等高线的骨模型的设计图。 Figure 4 (a) shows the gypsum model (a bone model) obtained by Fig 4 (b) shows a side view of a bone model, Figure 4 (c) shows the bone model depicts the contour lines of the design. 本实施例采用的是未描绘等高线（或网格图案）的骨模型，但优选采用图4(c) 所示的描绘有等高线的骨模型，因为采用该模型能容易地确定骨变形或易形成骨的部位。 The present embodiment uses contour lines (or grid patterns) of the bone model not depicted, but is preferably used in Fig. 4 (c) depicts the bone model shown in contour, because the use of the model can be readily determined bone deform or easy to form bone site.

[0227] 接下来，将造型材料设置在骨模型上。 [0227] Next, the molding material on the bone model. 即，设置造型材料来修正变形。 That is, setting modeling material to correct distortion. 具体而言，将骨填充材设置在图3(a)、图3(b)以及图4(a)所表示的骨填充区域（凹陷部位）。 Specifically, the bone filling material disposed in FIG. 3 (a), FIG. 3 (b) and 4 bone filling area (the recessed portion) (a) represents. 图5 (a) 是主视图，图5(b)是侧视图，图5(c)是仰视图。 Figure 5 (a) is a front view, FIG. 5 (b) is a side view, FIG. 5 (c) is a bottom view. 本实施例中的造型材料是粉色，所以能清晰地识别出上蜡部分（设置有造型材料）。 Molding material of the present embodiment is pink, it is possible to clearly identify the waxing section (provided with the molding material).

[0228] 接下来，通过CT扫描将设置有造型材料的骨模型图像化。 [0228] Next, by CT scan images are provided bone model modeling material. 图6是设置有造型材料的骨模型的CT图像，以此替代附图。 Figure 6 is provided with a bone model of the CT image-forming material, as an alternative to the accompanying drawings. 图6(a)是表示脸颊部分的CT图像的图，图6(b)是表示下颚部分的CT图像的图。 Figure 6 (a) shows a CT image of cheek parts, and FIG. 6 (b) is a CT image showing the jaw portion of FIG. 如图6(a)和图6(b)所示，通过CT扫描可清晰地分辨出骨模型部分和造型形成部分。 As shown in Figure 6 (a) and 6 (b), by CT scan can clearly distinguish bone model portion and forming part of modeling. 根据获得的图像形成部分的三维数字图像，并按照快速原型法来制造骨填充材。 Three-dimensional digital image forming section based on images obtained, and in accordance with the rapid prototype method to manufacture a bone filler. 在获得的骨填充材上分别设置有三个直径为0. 5mm〜1. 5mm的孔。 Are respectively provided on the bone filler obtained apertured 0. 5mm~1. 5mm diameter three. 这些孔用于植入骨填充材时让固定用线等穿过。 Let fixed lines, and through these holes for implantation of a bone filler. 图7是本实施例中获得的骨填充材的照片，以此替代附图。 Fig. 7 is obtained bone filler photos to this embodiment, as an alternative to the accompanying drawings. 图7(a)是植入脸颊部分的骨填充材的图，图7(b)是表示图7(a)中所述骨填充材的内表面的图。 Figure 7 (a) is implanted in the cheek bone filler portion, and FIG. 7 (b) shows 7 (a) in the inner surface of the bone filling material of FIG. 图7 (c)是表示植入下颚部分的骨填充材的图，图7(d)是表示图7(c)中所述骨填充材的内表面的图。 Figure 7 (c) shows a portion of the lower jaw bone implant filler, and FIG. 7 (d) is a diagram showing an inner surface 7 (c) in the bone filler of FIG.

[0229] 接下来，实施手术，将获得的骨填充材植入患者体内。 [0229] Next, surgery, bone filler obtained implanted in the patient. 手术结果显示在图8中。 Surgical results are shown in Figure 8. 图8是表示其上描绘有等高线的石膏像（外观模型）的照片，以此替代附图，所述等高线表示了用实施例中获得的骨填充材实施手术后的患者面部的高低起伏。 Figure 8 shows the contour lines on which is drawn in plaster (appearance models) pictures, as an alternative to the drawings, the contour line represents a patient's face with bone filling material obtained in Example embodiments of post-operative ups and downs. 图8(a)是手术前的图， 图8(b)是手术后的图。 Figure 8 (a) is before the surgery, and Fig. 8 (b) is a view after surgery. 通过比较图8(a)和图8(b)可知，术后的骨变形程度小于术前的骨变形程度。 By comparing Figure 8 (a) and 8 (b) shows that the degree of deformation of bone surgery is less than the degree of preoperative bone deformation.

[0230] 工业实用性 [0230] Industrial Applicability

[0231] 本发明的骨模型或外观模型可适用于医疗用器械产业等领域，采用这些模型，医生等可容易、准确地确定患者的骨变形。 [0231] bone model or the appearance model of the present invention may be applied to the medical device industry and other fields, the use of these models, doctors can easily and accurately determine the patient's bone deformation.

[0232] 本发明的骨填充材的制造方法可适用于医疗用器械产业等领域，采用该方法可有效地修复或矫正骨缺损或骨变形等。 [0232] A method for producing a bone filler of the present invention can be applied effectively repair or correction of bone defects or bone deformation in the medical device industry and other fields, using this method.