200422028 玖、發明說明 【發明所屬之技術領域】 本發明係關於-種製造方法及其成品，特別指— 備簡易、成本低廉而可維持病患於兩次骨科手術間^ 能之人工骨骼系統暫時性替代物製造方法及其成品。 5【先前技術】 八〇Π -十世紀以降，人類平均壽命隨§學技術之長足進步 有逐漸延長之趨勢。然相對之下，人體骨絡、關節亦料 齡增長而退化或因長期使用磨損，而產生疼痛或益 良好運動功能。當關節病變嚴重時，人工關節置_可明 10 顯解除疼痛並改善關節功能。 至於人工關節置換術後之併發症以感染(infection) 最具破壞力，其可能發生於術後數日内，亦可能於數年後 始發生，而細菌感染主要來源則為皮膚、口腔及泌尿道。 感染發生後輕者需以抗生素治療，重者則需將人工關節拔 15除、清創，待❹控制後再植入新人工«，即所謂人工 關節二次重建手術。 目前於臨床上人工關節二次重建手術之實施，於原人 工關節拆除後之關節腔及骨髓腔開口，通常係以骨水泥與 抗生素結合之球狀或塊狀物填塞，經約二至三個月治療期 以控制發k、感染或如癌症等其他病症後，始進行新2工 關印之二次重建手術。惟於該數月之治療期間，由於缺少 正常或人工關節提供之轉動及支撺機轉，使f亥關節部位無 法正常活動而多半保持固定狀態，不僅明顯影響病患之曰 常生活品質，其間所導致患部肌肉軟組織之萎縮退化，更 6 200422028 玖，'發明ϋ§ 手術之困難度及未可預期之後遺症。 將&局後績二次重建 【發明内容】 本發明之主要目的，即在提供_種維持病患於 兩次骨科手術間活動功能之人工骨路系統暫時性替代物製 5 造方法及其成品。 、二本發明之次一目的，即在提供一種為二次手術作預先 / 口療之人m统暫時性替代物製造方法及其成品。 /發明之另—目的，即在提供—種製作成本低廉之人 工骨絡系統暫時性替代物製造方法及其成品。 片本發明之再_目的’即在提供—種製備快速簡易之人 工骨骼系統暫時性替代物製造方法及其成品。 於是，本發明人工骨骼系統暫時性替代物製造方法， 包括下述步驟：⑴製備一模具，該模具内部形成一對應 υ *替代物預疋形狀之内模空間；⑺將該模具對應該内模 15空間之内表面進行便於脫模所需之表面處理；(3)將該模 具内表面進行滅菌以確保其潔淨度；（4)將一特定内模原 料注=該模具内模空間；⑸令該模具靜置一預定時間待 该内模原料固化；及⑻自該模具取出該替代物成品。 【實施方式】 20 本發明之前述以及其他技術内容、特點與優點，於以 配a參考圖式之較佳實施例詳細說明中，將可清楚明白 罘一、五圖所示，本發明人工骨骼系統暫時性替代 物製造方法較佳實施例，主要包括第一圖所示各主要實施 200422028 玖、發Θ獅月 V驟’而用以製造如第五圖所示之一人工膝關節2。本實 2例中人卫膝關節2係以—固定安I於人體股骨遠端之股 骨段人工關節為例，而可與另一腔骨段人工關節（圖未示） 相配。以形成疋整之人工膝關節機轉。然如熟悉本技藝人 5 士易於思及者，本發明亦可適用於如體關節或人體、動物 /、他位之人工關節，或骨骼系統之人工骨塊、組織及人 工植入物等，而不限於本實施例所舉之型式。 如步驟11所示，首先決定複數標準型號之人工膝關 節2尺寸，以依有膝關節置換需求之患者個人之生理及解 10 :]學條件，如其年齡、性別、體能狀況、病例、步態、身 雨、體重等資料，而自各標準型號中擇一最適者供患者進 行手術置換。 如步驟⑴至⑴所示，各人工膝關節2標準型號尺 寸之決定步驟1卜進—步包含—解剖學量測步驟⑴、一 15分類統計步驟112、一設計參數參考步驟u3及一標準型 號尺寸運算步驟114。解剖學量測步驟iu係藉如核磁共 振，影術（MRT)、電腦斷層掃描⑽或其他f用方式，自 —定數量樣本活體或解剖大體上取得膝關節部位數據。當 …、由於各人種、民族間人體體型亦可能存有明顯差異， Μ故該量測步驟1U以能針對擬安裝該人工關節2之患者所 屬人種或國別進行為最佳，或至少區分為如東方人、西方 人等幾種主要體型資料庫。 分類統計步驟112則將由解剖學量測步驟111獲得採 自不同樣本之人體膝關節尺寸資料，依前述預定製作之人 200422028 玖、發0獅月 工膝關f 2標準㈣之數量（如分為三種型號）予以分類統 計，以求得各型號對應之解剖學數據均值。其中分類基準 可如年齡、身高、體重、性別等。 5 10 15 依據經分類統計步驟112獲得之各組人體膝關節尺寸 均值’配合設計參數參考步* 113，即可如標準型號尺寸 運算步驟114所示，以任何習知方式或既有軟體運算，而 獲得對應之各標準型號之人工膝關節2尺寸。豆中，…十 參數參考㈣113中之設計參數，係W床統計或理論 所得人工膝關節各元件之較佳設計參數值，以我國為例， 於 UU，H.C.(劉華昌），“Review of Gross Anatomy of the Chinese Knee,» J〇Urnal 〇f the200422028 发明 Description of the invention [Technical field to which the invention belongs] The present invention relates to a manufacturing method and a finished product thereof, in particular,-an easy-to-use, low-cost, artificial bone system capable of maintaining a patient in two orthopedic operating rooms ^ temporarily Manufacturing method and finished product. 5 [Previous technology] From 80th century to the 10th century, the average life expectancy of human beings has gradually increased with the advancement of §learning technology. However, in contrast, the bones and joints of the human body are degraded as they age or become worn out due to long-term use, resulting in pain or good motor function. When joint disease is severe, artificial joint placement can significantly relieve pain and improve joint function. As for the complications after artificial joint replacement, infection is the most destructive. It may occur within a few days after surgery, or it may start several years later. The main sources of bacterial infections are skin, mouth and urinary tract. . After infection, mild patients need to be treated with antibiotics, and severe patients need to be removed, debrided, and implanted with a new artificial «after the control, which is the so-called secondary reconstruction of artificial joints. At present, the second artificial reconstructive surgery of artificial joints is performed clinically. The joint cavity and bone marrow cavity openings after the original artificial joints are removed are usually filled with a ball or block combined with bone cement and antibiotics. After about two to three After the monthly treatment period to control the development of infection, infection or other diseases such as cancer, the second reconstruction operation of the new 2 workers is performed. However, during the months of treatment, due to the lack of normal or artificial joints to provide rotation and support mechanism, the f Hai joint site could not move normally and remained mostly fixed, which not only significantly affected the daily quality of life of the patients, during which The resulting atrophy and degradation of the muscle and soft tissue of the affected area, and more 2004200428, "Invention" § the difficulty of surgery and unanticipated sequelae. [Reconstruction of the & post-office performance] [Summary of the invention] The main purpose of the present invention is to provide a method of temporarily replacing the artificial bone system to maintain the function of the patient between two orthopedic operations. Finished product. Second, a second object of the present invention is to provide a method for manufacturing a temporary substitute for a person who performs pre / oral treatment for a second operation and a finished product thereof. / Another purpose of the invention is to provide a method for manufacturing a temporary substitute for an artificial bone network system with low production cost and a finished product thereof. A further object of the present invention is to provide a method for producing a temporary substitute for an artificial skeletal system which is quick and easy to prepare and a finished product thereof. Therefore, the method for manufacturing a temporary substitute of the artificial skeletal system of the present invention includes the following steps: (1) preparing a mold, and forming an internal mold space corresponding to the shape of the υ * replacement in the mold; (2) aligning the mold with the internal mold. 15 The inner surface of the space is subjected to the surface treatment required for easy demolding; (3) the inner surface of the mold is sterilized to ensure its cleanliness; (4) a specific inner mold raw material is injected into the inner space of the mold; The mold is left to stand for a predetermined time until the raw material of the inner mold is cured; and, the finished product of the substitute is removed from the mold. [Embodiment] 20 The foregoing and other technical contents, features, and advantages of the present invention will be clearly understood in the detailed description of the preferred embodiment with reference to the drawings. Figures 1 and 5 show the artificial skeleton of the present invention. The preferred embodiment of the method for manufacturing a temporary substitute of the system mainly includes the main implementation of 200422028 shown in the first figure, and Θ lion month V step 'to manufacture an artificial knee joint 2 as shown in the fifth figure. In this case, the human knee joint 2 is based on the artificial joint of the femoral segment fixed to the distal end of the human femur as an example, and can be matched with another cavity joint artificial joint (not shown). To form a tidy artificial knee joint. However, if the person skilled in the art is easy to think about, the invention can also be applied to body joints or human, animal / other artificial joints, or artificial bone blocks, tissues and artificial implants of the skeletal system, etc. It is not limited to the type mentioned in this embodiment. As shown in step 11, first determine the size of the artificial knee joints of multiple standard models to meet the individual physiology and solution of patients with knee replacement needs. 10:] academic conditions, such as their age, gender, physical condition, case, gait , Body rain, weight and other data, and one of the standard models is selected for the patient for surgical replacement. As shown in steps ⑴ to ⑴, each artificial knee joint 2 determines the size of the standard model. Step 1 includes the following steps:-Anatomical measurement step ⑴, a classification and statistics step 112, a design parameter reference step u3, and a standard model. Size calculation step 114. The anatomy measurement step iu is to obtain knee joint data from a fixed number of samples in vivo or anatomy, such as nuclear magnetic resonance, radiography (MRT), computed tomography, or other methods. When ..., there may also be significant differences in body shape between races and ethnic groups, so the measurement step 1U is best performed for the race or country of the patient who intends to install the artificial joint 2, or at least Divided into several major body databases such as Orientals and Westerners. The classification and statistics step 112 will obtain the human knee size data obtained from different samples from the anatomy measurement step 111. According to the aforementioned predetermined production person 200422028 玖, the number of hair standard l 2 ㈣ (such as divided into Three models) to classify statistics to obtain the average anatomical data corresponding to each model. The classification criteria can be such as age, height, weight, gender, and so on. 5 10 15 According to the classification and statistics of the human knee joints obtained in step 112, the design parameter reference step * 113 can be used to calculate the standard model size calculation step 114 in any conventional manner or existing software. And obtain the corresponding artificial knee joint size 2 of each standard model. In the bean, ... the ten parameters refer to the design parameters in ㈣113, which are the best design parameter values of artificial knee joint components obtained from W bed statistics or theory. Take China as an example. UU, HC (Liu Huachang), "Review of Gross Anatomy of the Chinese Knee, »J〇Urnal 〇f the
Association, Vol. 83, No. 3, pp. 317^325, March, 1984.-文中’即依據兩千多例膝關節置換手術經驗，揭 示如人工半月板厚度至少須在8咖以上及人工膝關節厚度 需限制於40mm以下等較佳設計參數，而皆可作為標準型 號尺寸運算步驟114之設計條件參考。 、經步驟11而決定各組標準型號人工膝關節2設計尺 寸後，即進入步驟12之模具製備階段。模 包含-立體圖製作步驟121、一模具形成步驟12;、一表 20 面處理步驟124及一滅菌步驟125。立體圖製作步驟121 係依據步驟11所獲得各組標準型號人工膝關節2設計尺 寸，以如Pro-E、AUTOCAD或其他模具製造業習用電腦軟 體’繪製各人工膝關節2成品之立體圖。 而後，模具形成步驟122即依據人工膝關節2立體尺 9 200422028 玫、發明I娜 寸，藉習知如⑽設備、翻製、射出成型、鑄造或其他任 何適當模具製作方式，將模具材料加工形成第二、三圖所 示對應各組標準型號人工膝關節2之模具（外模）3。為考 慮形成之人工膝關節2與人體結構組織之相容性及潔淨度 5 ，模具㈣彡貞為符合勝13485及勝刪3標準之工程 材料，如金屬類之不錢鋼、礙鋼、欽合金、姑_路_翻合金 ’及非金屬類之PLLA、PMMA、PE、pp、ABS、麗、石夕膠 及 TEFLON 等。 此外由於月路系統體積大小不同，模具3可包含單 10 -或複數（本實施例以四塊為例）模具組件31，而於兩兩 模具組件31間藉一鉚釘32或如内釘、㈣固定或其他習 知組固方式組合後，於其内部共同包圍界定一供形成各人 工膝關節2(内模)之内模空間33,模具3表面並向内預留 開設-連通内模空間33而供内模材料注入之填注孔％。 15 纟實施例中表面處理步驟124則係於模具3與用以形 成人工膝關f 2之特定内模原料接觸之内表面予以抛光 Ooiish)，以去除模具3内表面產生之微小氣孔，並防止 核具3與6亥内模原料接觸後發生不可逆之化學反應而致脫 核困難。而其他變化例中，表面處理步驟】24亦可藉不同 2〇方式達成’如於模* 3内表面以包覆（c〇ating)、喷佈 (spraying)或黏合等外加方式形成一利於脫模之材料（如 TEFLON、礼矽膠）表層，或於模具3内表面施加適當潤化 劑，或其他任何使脫模易於進行之習知方式皆可適用。 滅la y驟1 25則係藉蒸氣滅菌（aut〇ciave)、放射線 10 200422028 玖、獅删 (Gamma ray)或其他適當醫療器材滅菌方式施加於模具3， 以確保模具3本身及其形成之人工膝關節2之潔淨度。 經步驟12獲得各組標準型號人工膝關節2之對應模 具3後，即可如步驟13而進一步製備人工膝關節2成品 5 。人工膝關節製備步驟13包含一混合步驟ι31、一填注 步驟132、一固化步驟133及一脫模步驟134。 混合步驟131係將一般骨科手術常用之填充材料，或 他與人體生物相谷性良好或不具細胞毒性且符合I s〇_ 13485及ISO-10993標準之生醫材料，與一水或其他適當 1〇溶液或膠狀物混合攪拌均勻，使其呈半固體狀態，各材料 亦可混合使用或先後依序加入水溶液。上述材料包含如 PMMA、硫酸鈣、磷酸鈣及類似混合物、氫氧基磷灰石 及類似混合物或其他任何適當材質，而又以具應力支撐強 度及耐磨性之材料尤佳，且由於本發明獲得之人工膝關節 15 2係供兩次手術間暫時替代之用，故其要求之耐磨強度不 如其支撐強度重要，而需以應力支撐強度作為材料選用之 百要考量。以支撐強度及耐磨性為例，上述例舉材料中， 以PMMA支撐強度及财磨性最佳，碌酸妈、氯氧基碟灰石 及其類似混合物次之，而以硫酸弼最劣。此外，於混合步 20 =⑶中，並可將如治療發炎之抗生素、抗癌藥物或其他 吊用藥物、顯影劑等共同或單獨混合加入骨科填充或植入 物材料中，使人工膝關節2成品植入人體後，有助於治療 心邛病變處.或具其他醫學治療及診斷用途。 填注步驟132係藉擠壓、注射或其他習知方式，將混 11 200422028 玫，谈剩縦刀 5 10 15 20 合步驟m獲得之骨科填充或植入物材料與水之混合流體 ’經模具3表面之填注孔34注入内模空間33。而後如固 化步驟133所示，待靜置-足夠時間使上述混合物凝固後 、，如脫模步驟134所示令各模具組件31分離，即可取出 並獲得符合預定形狀之各人工膝關節2成品。此外，於填 注步驟132十，骨科填充或植入物材料與水亦可依序注入 内模空間33 ’而非限於如上述先經混合後同時注入。 填注步驟132係藉漏、注射或其他f知方式，將混 合步驟⑶獲得之骨科填充或植入物材料與水之混合流體 ，經模具3表面之填注孔34注入内模空間33。而後如固 化步驟133所示，待靜置一足夠時間使上述混合物凝固後 、’如脫模步驟134所示令各模具組件31分離，即可取出 並獲得符合預定形狀之各人卫膝關節2成品。 如第四、五圖所示，人工膝關節2成品主要且有一呈 ^定弧面而用以與一脛骨段人工關節對應弧面（或於腔骨 方另設m狀板）滑動摩擦之—對鍊骨 插二自課骨部21上緣向上凸伸之固定桿22,藉固 =二插_持於手術患者股骨遠端切除後骨黯腔，而 二人工膝關節2成品於使用中之支撐強度及穩定度。 替神：：上述製程’本發明揭示一種人工骨路系統暫時性 替代物製造方法及其成品，就使用病患之生活便利性而言 以上述所舉之人卫膝關節 置換術前約二、：個月孔病心於下次關節 人H —個月之治療期間，作為-簡易而暫時性 關郎替代物’使病患得以維持相當之行動能力而享有 12 200422028 _ 一… 良好之生活品質 而就醫療觀點視之，藉由_ 〜 維持病串、a 即暫時性替代物而 ' 卩此力’亦間接幫助病患患 之運動而防止其萎縮退化」肌内軟組織 乃絲、虫产二士 -一-入重建手術之困難度 合抗生素、抗癌藥物0他且2代㈣科中可如前述結 輿物… I、他具治療、診斷效果之藥物或化 于更八為—次手術作預先治療之積極意義。 尤其重要者，就製作成本考量，本發明製程中獲得之 ίο 吴具3’可直接提供臨床醫師利用前述一般骨科手術常用 之填充材料，快速模製獲得該人工關節暫時性替代物，盆 要求之材料耐磨度及成品外形精確度皆不需如一般人工關 節嚴格’故不論模具本身及内模材料之製作成本盥一般人 工關節相較皆屬低廉，而可普及化嘉惠廣大之關節病變患 者0 15 冑後’就製備時效而言，由於該暫時性替代物可由醫 師取付权具3後.，直接於其手術室内利用易於取得之骨科 填充植入材料進行内模灌注而成形，故其製作快速而可及 時配合病患之手術使用，以將病患身心之不適減至最低。 惟以上所述者，僅為本發明之較佳實施例而已，當不 20能以此限定本發明實施之範圍，即大凡依本發明申請專利 範圍及發明說明書内容所作之簡單等效變化與修飾，皆應 仍屬本發明專利涵蓋之範圍内。 【圖式簡單說明】 第一圖為本發明人工骨骼系統暫時性替代物製造方法 13 200422028 玖、發明I綳 較佳實施例之實施流程圖； 第二圖為該較佳實施例獲得之一模具分解側視示意圖 第三圖為該模具之組合側視示意圖； 5 第四圖為該較佳實施例獲得之一人工膝關節側視示意 圖；及 第五圖為該人工膝關節之立體不意圖。；及Association, Vol. 83, No. 3, pp. 317 ^ 325, March, 1984.-In the text, based on more than 2,000 knee replacement surgery experiences, it is revealed that if the thickness of the artificial meniscus must be at least 8 coffee and the artificial knee Joint thickness needs to be limited to less than 40mm and other preferred design parameters, and can be used as a reference for design conditions of standard model size calculation step 114. 2. After step 11 determines the design size of each standard model of artificial knee joint 2, it enters the mold preparation stage of step 12. The mold includes a three-dimensional drawing making step 121, a mold forming step 12, a table 20 surface processing step 124, and a sterilizing step 125. The three-dimensional drawing making step 121 is based on the design dimensions of the artificial knee joints 2 of each standard model obtained in step 11, and the three-dimensional drawings of the finished artificial knee joints 2 are drawn using, for example, Pro-E, AUTOCAD, or other custom computer software for mold manufacturing. Then, the mold forming step 122 is based on the artificial knee joint 2 three-dimensional ruler 9 200422028, inventing the I-inch, and using conventional Rugao equipment, turning, injection molding, casting or any other suitable mold manufacturing method, the mold material is processed to form The second and third figures show the molds (outer molds) 3 of each standard model of artificial knee joint 2. In order to consider the compatibility and cleanliness of the formed artificial knee joint 2 and human body structure and tissues 5, the mold ㈣ 彡 为 is an engineering material that meets the standards of Sheng 13485 and Sheng 3, such as metal stainless steel, obstructing steel, Qin Alloys, alloys and alloys, and non-metallic PLLA, PMMA, PE, pp, ABS, Li, Shi Xijiao and TEFLON. In addition, due to the difference in the volume of the moon system, the mold 3 may include a single 10-or a plurality of mold components (in this embodiment, four pieces are used as examples), and a rivet 32 or a nail such as an internal nail or a cymbal is borrowed between the two mold components 31. After fixing or combining with other conventional methods, an inner mold space 33 for forming each artificial knee joint 2 (inner mold) is bounded together in the interior, and the surface of the mold 3 is reserved and opened inwardly-connecting the inner mold space 33 The filling hole% for the inner mold material injection. 15 表面 In the embodiment, the surface treatment step 124 is performed on the inner surface of the mold 3 that is in contact with the specific inner mold raw material used to form the artificial knee f 2 (Polishing Ooiish) to remove the tiny air holes generated on the inner surface of the mold 3 and prevent The irreversible chemical reaction occurs when the calibrator 3 comes in contact with the raw material of the inner mold of 6H, which makes the denuclearization difficult. In other variations, the surface treatment step] 24 can also be achieved by different 20 methods, such as forming the inner surface of the mold * 3 by means of coating, spraying, or gluing to facilitate removal. The surface of the mold material (such as TEFLON, Silicone Silicone), or an appropriate wetting agent is applied to the inner surface of the mold 3, or any other conventional way to make demolding easy to apply can be applied. Extinction la y step 1 25 is applied to mold 3 by steam sterilization (autociave), radiation 10 200422028 玖, Gamma ray or other appropriate medical equipment sterilization method to ensure mold 3 itself and the artificial Cleanliness of knee joint 2. After obtaining the corresponding mold 3 of each standard model of the artificial knee joint 2 through step 12, the finished artificial knee joint 2 can be further prepared according to step 13. The artificial knee joint preparation step 13 includes a mixing step ι31, a filling step 132, a curing step 133, and a demolding step 134. The mixing step 131 is a filling material commonly used in general orthopaedic surgery, or a biomedical material that has good or non-cytotoxicity with human biological organisms and meets ISO 13485 and ISO-10993 standards, and monohydrate or other appropriate 1 〇 The solution or glue is mixed and stirred evenly, so that it is in a semi-solid state, and the materials can also be mixed and used or sequentially added to the aqueous solution. The above materials include materials such as PMMA, calcium sulfate, calcium phosphate and similar mixtures, hydroxide apatite and similar mixtures, or any other suitable materials, and materials with stress support strength and abrasion resistance are particularly preferred. The obtained artificial knee joint 15 2 is used for temporary replacement between two operations. Therefore, the required abrasion resistance is not as important as its support strength, and it is necessary to consider the stress support strength as a material selection. Take support strength and abrasion resistance as examples. Among the above-mentioned materials, PMMA has the best support strength and abrasion resistance, followed by lutetium acid, chlorooxydarkite and similar mixtures, and thorium sulfate is the worst. . In addition, in the mixing step 20 = ⑶, antibiotics, anticancer drugs or other suspending drugs, and contrast agents such as those used to treat inflammation can be mixed together or separately into orthopedic filling or implant materials, so that the artificial knee joint 2 After the finished product is implanted into the human body, it can be used to treat palpitations. It can also be used for other medical treatment and diagnostic purposes. The filling step 132 is by extrusion, injection or other conventional methods, mixing 11 200422028 rose, and talking about the remaining trowel 5 10 15 20 combining the orthopedic filling or implant material and water obtained in step m through the mold. The filling holes 34 on the three surfaces are injected into the inner mold space 33. Then, as shown in curing step 133, stand still-after sufficient time for the above mixture to solidify, separate each mold component 31 as shown in demolding step 134, and then take out and obtain each artificial knee joint 2 finished product that conforms to a predetermined shape. . In addition, at the filling step 132, orthopedic filling or implant material and water may be sequentially injected into the inner mold space 33 'instead of being limited to being mixed first and then simultaneously injected. The filling step 132 is to omit, inject, or other known methods, the orthopedic filling or the mixed fluid of the implant material and water obtained in the mixing step (3) into the inner mold space 33 through the filling holes 34 on the surface of the mold 3. Then, as shown in the curing step 133, after standing still for a sufficient time to allow the mixture to solidify, 'the mold components 31 are separated as shown in the demolding step 134, and then each person's knee joint 2 conforming to a predetermined shape can be taken out and obtained. Finished product. As shown in the fourth and fifth figures, the finished product of the artificial knee joint 2 mainly has a curved surface and is used to slide friction with the corresponding curved surface of a tibial segment artificial joint (or an m-shaped plate is set on the cavity side) — The fixation rod 22 that protrudes upward from the upper edge of the bone portion 21 of the osteosynthesis 2 is inserted into the osteotomy cavity of the patient's distal femur after the distal femur is removed, and the two artificial knee joints 2 are used in support. Strength and stability. Replacement: The above process: The present invention discloses a method for manufacturing a temporary substitute for an artificial bone system and a finished product thereof. In terms of the convenience of using a patient, the above-mentioned human knee joint replacement surgery is performed about two times before the operation. : Monk hole disease heart during the next joint H-month treatment period, as a-simple and temporary substitute for Guan Lang's, so that patients can maintain a considerable ability to move and enjoy 12 200422028 _ one ... good quality of life From the medical point of view, by maintaining _ ~ the disease string, a is a temporary substitute, and '卩 this force' also indirectly helps the patient's movement and prevent its atrophy and degeneration. "Intramuscular soft tissue is silk and insect production. The degree of difficulty in entering reconstruction surgery combined with antibiotics and anticancer drugs is 0, and the 2nd generation pediatrics can be as described above ... I. Other drugs with therapeutic and diagnostic effects may be used in one operation. The positive significance of pre-treatment. Especially important, considering the cost of production, the Wu Ju 3 'obtained in the process of the present invention can directly provide clinicians with the aforementioned filling materials commonly used in general orthopedic surgery to quickly mold to obtain the temporary replacement of artificial joints. The abrasion resistance of the material and the accuracy of the finished shape do not need to be as strict as general artificial joints. Therefore, regardless of the cost of the mold itself and the material of the internal mold, the general artificial joints are cheaper, and can be used to benefit the majority of patients with joint disease. 0 15 胄 后 'In terms of preparation aging, as the temporary substitute can be obtained by the physician after payment of the tool 3, it is directly formed in its operating room using an easily accessible orthopedic filling implant material for internal mold perfusion and shaping, so it is produced It can be used quickly and in time with the patient's surgery to minimize the patient's physical and mental discomfort. However, the above are only the preferred embodiments of the present invention, and the scope of implementation of the present invention can be limited by this, that is, simple equivalent changes and modifications made according to the scope of the patent application and the content of the invention specification of the present invention. , All should still fall within the scope of the invention patent. [Brief description of the drawings] The first diagram is a flow chart of a method for manufacturing a temporary substitute for the artificial skeletal system of the present invention 13 200422028 (I), a preferred embodiment of the invention I; the second diagram is a mold obtained from the preferred embodiment Exploded side view. The third figure is the combined side view of the mold. The fourth figure is a schematic side view of an artificial knee obtained in the preferred embodiment. The fifth figure is the three-dimensional intention of the artificial knee. ;and
1010
14 200422028 玖、發嗎綳 【圖式之主要元件代表符號簡單說明】 2 人工膝關節 3 模具 31 模具組件 32 鉚釘 33 内模空間 34 填注孔 21 髁骨部 22 固定桿14 200422028 玖 、 发 綳 綳 [Simplified description of the main symbols of the drawings] 2 Artificial knee joint 3 Mold 31 Mold assembly 32 Rivet 33 Space in the inner mold 34 Filling hole 21 Metatarsus 22 Fixing rod