200936112 九、發明說明： 【發明所屬之技術領域】 本發明係與人工關節之製作以及置換器具有關，特別 是指一種達成微骨切量且表面置換型人工關節的製作方法 及置換器具。 【先前技術】200936112 IX. OBJECTS OF THE INVENTION: TECHNICAL FIELD The present invention relates to the manufacture of artificial joints and replacement appliances, and more particularly to a method and a replacement device for achieving a micro-bone cut and surface replacement type artificial joint. [Prior Art]
按’人類的關節於成年後，其自行修補的能力便大幅 下降’因此當關節因疾病或外力而受損造成骨關節面之退 化時’將會導致嚴重的畸型或感覺疼痛，而無法維持正常 1〇生活或工作，如：退化性關節炎、類風濕性關節炎、骨頭 缺血性壞死…等等疾病，嚴重時可能需要置換人工關節以 減少身體上的不適與生活中的不便。 而習用之人工關節多為量產規格化，所以需要配合既 有人工關節的外型與尺寸來切除患位骨關節，而通常被切 15除的部份皆會大於患位骨關節上之退化或損壞的區域，加 上置換的人工關節並非專為該患位所訂作，因此常會有手 術後人工關節之外型貼合不佳，而造成患位的不適。另一 方面:針對，骨切量的人H由於要求人卫_與自 節f到：的曲面貼和度’但由於醫生使用-般的手術 2〇 易將人卫關節達到如此®的置放精確度，如 工關節更換手術，而且後續須置換 關節置換，如此一來%m部分關節置換逐步擴大為全 對於患者的身心將產生很大的煎熬； 丄t二關節使用壽命上的損害，因此部分之患者有 4 200936112 而用於切除患位骨關節之手術器具，皆需醫生用以大力敲 打’若疋猶有不慎，亦容易造成患者關節上的二次傷害。 如上所述，習用之人工關節的製作及置換器具，確有 其設計結構與手術安裝上的缺陷，以待改進。 【發明内容】 ❹ 15 本發明之主要目的在於提供一種達成微骨切量且表面 置換型人工關節的製作方法，其可以達成客製化人工關節 的目的。 本發明之次一目的在於提供一種達成微骨切量且表面 置換型人工關節的置換器具，其可以達到微骨切量與精準 定位之目的。 ^ 、、緣是，為了達成前述目的，依據本發明所提供之一種 達成微骨切量且表面置換型人工關節的製作方法及置換器 具，其中製作方法包含有以下步驟：（a).以—放射線成像 裝置取知複數張患位骨關節之二維連續切片醫學影像資 訊；（b).逆向分析該等複數患位骨關節之二維資訊，產生 :虛擬患位骨關節之三維資訊；（〇 ·藉由該虛擬患位骨關 即之二維資訊’判定該患位骨關節之退化區域及需要手術 切除之外表邊界麟度等；（d) ·整合臨床醫學相對於該邊 界内之正常骨關節三維資訊’於該虛擬患位骨關節上重新 邊界内之虛擬理想之骨關節三維資訊，替代該虛擬 ^位月關節之該邊界内之三維資訊；以及，（e).根據步驟 d.所得之該邊界内虛擬理想之骨關節之三維資訊製作一人 5 20 200936112 工關節。According to 'human joints, their ability to repair themselves is greatly reduced after adulthood. Therefore, when the joint is damaged due to disease or external force, the joint surface will be degraded, which will cause severe deformity or pain, and it will not be able to maintain normal. 1 〇 life or work, such as: degenerative arthritis, rheumatoid arthritis, avascular necrosis of bones, etc., in severe cases, it may be necessary to replace artificial joints to reduce physical discomfort and inconvenience in life. However, the artificial joints used in practice are mostly standardized for mass production, so it is necessary to replace the shape and size of the existing artificial joints to remove the affected bone joints, and the part usually removed by cutting 15 is larger than the degradation of the affected bone joints. Or the damaged area, plus the replacement artificial joint is not designed for the patient, so there is often a poor fit of the artificial joint after the operation, resulting in discomfort of the affected position. On the other hand, it is placed on the surface of the person who has a bone-cut amount, because it requires a person's health _ and the self-following degree to the surface of the surface. Accuracy, such as joint replacement surgery, and subsequent replacement of joint replacement, so that the %m partial joint replacement gradually expands to all of the patient's body and mind will have a great torment; 丄t two joints damage the service life, therefore Some patients have 4 200936112 and the surgical instruments used to remove the affected bones and joints require doctors to vigorously beat 'If you are not careful, it will easily cause secondary injuries on the joints of the patients. As described above, the conventional artificial joint manufacturing and replacement device has its design structure and surgical installation defects to be improved. SUMMARY OF THE INVENTION The main object of the present invention is to provide a method for producing a surface replacement type artificial joint that achieves micro-bone cutting amount, which can achieve the purpose of customizing an artificial joint. A second object of the present invention is to provide a replacement device for achieving a micro-bone cutting amount and a surface replacement type artificial joint, which can achieve the purpose of micro-bone cutting and precise positioning. In order to achieve the foregoing object, in accordance with the present invention, a method and a replacement device for achieving a micro-bone cutting amount and a surface replacement type artificial joint are provided, wherein the manufacturing method comprises the following steps: (a). The radiographic imaging device acquires two-dimensional serial slice medical image information of the plurality of affected bone joints; (b) reversely analyzes the two-dimensional information of the plurality of bones and joints of the affected position, and generates: three-dimensional information of the virtual joint bone and joint; 〇·Determination of the degenerative area of the affected bone and joint and the need to be surgically resected by the two-dimensional information of the virtual target bone bone; (d) Integrating clinical medicine with respect to normal within the boundary The three-dimensional information of the bone and joint 'three-dimensional information of the virtual ideal bone joint in the boundary of the virtual joint bone joint, replacing the three-dimensional information within the boundary of the virtual joint moon joint; and, (e). according to step d. The resulting three-dimensional information of the virtual ideal bone joint in the boundary is made by one person 5 20 200936112.
該置換器具包含有：一患位骨關節定位塊、一銑刀以 及一導引裝置，一患位骨關節定位塊，設有一以上之固定 件，且該患位骨關節定位塊設有一中間孔，該中間孔之邊 5框相對於該患位骨關節退化或損壞區域之邊界；該銳刀設 於該中央孔内’以及；該導引裝置，架設於一預定位置， 且可依預汉好之>訊導引該銳刀於該中央孔内動作。 藉此’本發明透過上述的方法及器具上之設計’可以 使人工關節的製作更符合病患本身的需求，達到人工關節 10客製化的目標，且不會為了配合規格化之人工關節而多切 除患位骨關節的正常骨骼，更由於置換器具的設置，使切 除後之患位骨關節恰可配合該等客製化之人工關節，使患 者可以容易適應人工關節之設置。The replacement device comprises: a suffering bone joint positioning block, a milling cutter and a guiding device, a suffering bone joint positioning block, more than one fixing member, and the affected bone joint positioning block is provided with an intermediate hole a side frame 5 of the intermediate hole is opposite to a boundary of the degenerated or damaged area of the affected bone joint; the sharp knife is disposed in the central hole; and the guiding device is erected at a predetermined position, and can be preliminarily The good one is to guide the sharp knife to move in the central hole. Therefore, the "the present invention through the above method and the design of the device" can make the artificial joint more suitable for the needs of the patient itself, achieve the goal of artificial joint 10 customization, and does not meet the standardized artificial joint. The normal bones of the affected bone joints are removed, and the replacement of the affected bones and joints can be matched with the customized artificial joints, so that the patient can easily adapt to the setting of the artificial joints.
15【實施方式；J 产為了詳細說明本發明一種微骨切量且表面置換型人工 關知的製作方法及置換器具之特點所在，兹將實施步驟及 搭配器具詳細說明如后 ，其中： 用參閱第一圖A，其係為本發明第一較佳實施例所提 2〇 ^之種微骨切量且表面置換型人工關節的製作方法，包 it列步驟：（a) ·以—放射線成像裝置取得複數張患位 月關卽之二維連續切片醫學影像資訊；（b).利用邊界圈選 與^體重建等影像處理技術，逆向分析該等複數張患位骨 關節之二維資訊，產生一虛擬患位骨關節之三維資訊；（C). 6 200936112 藉由該虛擬患位骨關節之三維資訊，並配合臨床醫師所提 供之患位病狀資訊，或再參考人工關節未加工前毛胚的立 體外型’藉以判定該患位骨關節退化區域及需要手術切除 之外表邊界與深度等；⑷.整合臨床醫學相對於該邊界内 5之正常骨關節三維資訊，於該虛擬患位骨關節上重新建立 2邊界内之虛擬理想之骨關節三維資訊，替代該虛擬患位 ❹ ^節之該邊界内之三維資訊，且依照該虛擬患位骨關節 關谛面之特性，調整該虛擬理想之骨關節三維資訊，該虛 擬理想之骨關節三維資訊，具有臨床醫學上理想之骨關節 10二維資訊的特性；以及，⑷根據步驟⑷所得之該邊界 内虛擬理想之骨關節的三維資訊，製作一人工關節，且該 士工巧節關節面之幾何結構’係符合於該虛擬理想之骨： f關節面幾何結構；同時該人工關節外緣之幾何結構，係 付CT於該邊界之幾何結構，另外該人工關節之底部設有若 ❸15干卡合部，以穩固與切除後之關節面結合。 Γ步驟（a).中之該放射線成像裝置係選自由核磁 /、振裝置、電腦斷層掃瞄機、x光機及其組合組成之群組。 再請參閱第—圖B，其係為本發明第二較佳實施例所 徒供之一種微骨切量且表面置換型人工關節的製作方法， 2〇其實施動作流程大致與第一較佳實施例類同，而其不同 後更包含有一步驟（b_l) ·對步驟(b)所得之 f ’三維資訊進行平滑化調整，例如：曲面修 表面曲率平滑化等程序，以使退化或損壞區域經修 補後的理想之骨關節曲面，能夠與未退化或損壞區域處的 200936112 曲率能平滑相接。其巾第二健實施例與第—較佳實施例 類同，不再累述。 再清參閱第二圖至第四圖，其係為本發明第三較佳實 5 ❹ 10 15 施例所提供之—種微骨切量且表面置換型人1關節的置換 器具，其中： 第二圖係為本發明第三較佳實施例之立體圖； 第二圖係為本發明第三較佳實施例之立體圖，A表示 本發明之使用狀態； 第四圖係為本發明第三較佳實施例之立體圖，其表示 本發明於患位骨_上所造成之祕孔與人工關節之底面 可完全卡合； 如第二圖所示，本發明第三較佳實施例所提供之一種 微骨切量且表面置換型人工關節的置換器具，可用於切除 患位骨關節18之退化或損壞的區域，該置換器具包含有： 一患位骨關節定位壤11、一銑刀12以及一導引裝置13。 該患位骨關節定位塊11，設有一以上之固定件14，且 該患位骨關節定位塊11設有一中間孔15，該中間孔15之 邊框相對於該患位骨關節18退化或損壞的區域之邊界；其 中，該固定件14可為一骨針，該患位骨關節定位塊u可 藉由一以上之骨針固定於患位骨關節18上，該患位骨關節 定位塊11之底面曲率係利用上述該虛擬理想之骨關節的三 維資訊製作，因此該患位骨關節定位塊11之底面曲率可穩 固的貼合於該患位骨外關節關節面之曲率。另一方面，該 患位骨關節定位塊11可由若干塊零件所組成，該等零件間 8 20 200936112 彼此有卡栀等機構，以達到容易結合之目的。 該銑刀12，係設於該中央孔15内，用以切削中央孔 15内之患位骨關節18退化或損壞區域。 5 ❹ 10 15 ❹ 該導引襞置13，架設於一預定位置，且可使該銳刀12 與該患位骨關節定位塊11之上表面保持一預定角度’並依 預設好之資訊，導引該銳刀12沿著中間孔15做繞轉動作， 同時該導引裝置13可使該銑刀12於一預訂深度内作動， 並避免銳刀12切削深度過淺或過深，使該銑刀12將該中 央孔15内患位骨關節18之退化或損壞區域完全切除，該 導引裝置13並可控制該銑刀造成之切切銑孔16之深度與 相對應之該人工關節17相同，使該切銑孔16之底面與相 對應之該人工關節17底面完全卡合，以達到進一步穩固人 工關卽17的目的。 其中，該銑刀12具有重切削刃邊之特性，且為了避免 切削時對骨組織所造成溫度傷害，該銑刀12於切削時之轉 速、進給量與扭矩等，皆已設定妥當。 由上可知，本發明所可達成之功效在於：使人工關節 的製作更符合病患本身對骨關節面高貼和度的需求，以達 到人工關節客製化的目標，而減少了病患於置換人工關節 後有適應不良的問題，且不會造成習用規格化人工關節， 所常見之切除過多患位骨關節中正常骨骼的問題，並配合 置換器具的設置，使切除後之患位骨關節切銑孔恰可配合 該等客製化之人工關節，因此於置換人工關節時可更便 捷，而患者也可減少置換人工關節時之不適。 9 20 200936112 因此，本發明可解決習用者在使用上與結構上之困擾與 不便，爰依法提出專利申請。 本發明之上述各構件僅係用來說明，並非用以限制本案 之申請專利範圍，其他之等效構件替換，亦應為本案之範圍 5 所涵蓋。 200936112 【圖式簡單說明】 第一圖A其係為本發明第一較佳實施例之步騾流程 圖； 第一圖B其係為本發明第二較佳實施例之步驟流程 5圖； 第二圖係為本發明第三較佳實施例之立體圖； 第三圖係為本發明第三較佳實施例之立體圖，其表示 本發明之使用狀態；以及 第四圖係為本發明第三較佳實施例之立體圖，其表示 10本發明於患位骨關節上所造成之切銑孔與人工關節之底面 可完全卡合。 【主要元件符號說明】 患位骨關節定位塊11 銑刀12 導引裝置13 15 ❹ 固定件14 中間孔15 切銑孔16 Α工關節17 患位骨關節18 1115 [Embodiment; J production in order to explain in detail a micro-bone cutting amount and surface replacement type manual knowledge of the manufacturing method and the characteristics of the replacement device, the implementation steps and matching instruments are described in detail, wherein: The first figure A is a method for manufacturing a micro-bone-cut and surface-replacement artificial joint according to the first preferred embodiment of the present invention, and the steps of the assembly are as follows: (a) ·-radiation imaging The device obtains two-dimensional serial slice medical image information of a plurality of positions of the patient; (b) reversely analyzes the two-dimensional information of the plurality of bones and joints of the affected position by using image processing techniques such as boundary circle selection and body reconstruction; Generating a three-dimensional information of a virtual joint bone joint; (C). 6 200936112 By using the three-dimensional information of the virtual joint bone joint, and matching the information of the patient's condition provided by the clinician, or referring to the artificial joint before processing The stereoscopic appearance of the embryo is used to determine the degenerative region of the affected bone joint and the surface boundary and depth required for surgical resection; (4) Integrate the three-dimensional normal joint of clinical medicine with respect to the boundary within the boundary. In the virtual joint bone joint, three-dimensional information of the virtual ideal bone joint in the two boundaries is re-established, replacing the three-dimensional information in the boundary of the virtual patient position, and according to the virtual joint bone joint The characteristics of the face, adjusting the virtual ideal bone joint three-dimensional information, the virtual ideal bone joint three-dimensional information, has the characteristics of clinically ideal bone joint 10 two-dimensional information; and, (4) virtual within the boundary obtained according to step (4) The ideal three-dimensional information of the bone joint, the artificial joint is made, and the geometric structure of the faculty joint surface is conformed to the bone of the virtual ideal: f joint surface geometry; and the geometric structure of the outer edge of the artificial joint The geometry of the CT is applied to the boundary, and the bottom of the artificial joint is provided with a dry joint of the iliac crest 15 to be firmly coupled with the articular surface after the resection. The radiation imaging apparatus in step (a) is selected from the group consisting of a nuclear magnetic/vibration device, a computed tomography scanner, an x-ray machine, and combinations thereof. Referring to FIG. 24 again, it is a method for manufacturing a micro-bone-cut and surface-replaceable artificial joint according to a second preferred embodiment of the present invention, wherein the implementation flow is substantially the same as the first one. The embodiments are similar, and the difference further includes a step (b_l). The smoothing adjustment of the f'3D information obtained in the step (b), for example, surface smoothing surface curvature smoothing, etc., to degenerate or damage the region The repaired ideal osteoarticular surface is able to smoothly interface with the 200936112 curvature at the undegraded or damaged area. The second embodiment of the towel is similar to the first preferred embodiment and will not be described again. Referring to the second to fourth figures, which are the third embodiment of the present invention, the micro-bone cutting and surface replacement type 1 joint replacement device provided by the third preferred embodiment of the present invention, wherein: 2 is a perspective view of a third preferred embodiment of the present invention; the second drawing is a perspective view of a third preferred embodiment of the present invention, A represents the state of use of the present invention; and the fourth figure is a third preferred embodiment of the present invention. A perspective view of the embodiment, which shows that the secret hole caused by the present invention on the bone of the affected bone can be completely engaged with the bottom surface of the artificial joint; as shown in the second figure, a microscopically provided by the third preferred embodiment of the present invention A bone replacement and surface replacement type artificial joint replacement device can be used for excising a degenerated or damaged area of the affected bone joint 18, the replacement device comprising: a suffering bone joint positioning soil 11, a milling cutter 12 and a guide Leading device 13. The affected bone joint positioning block 11 is provided with more than one fixing member 14 , and the affected bone joint positioning block 11 is provided with an intermediate hole 15 , and the frame of the intermediate hole 15 is degraded or damaged with respect to the affected bone joint 18 . a boundary of the region; wherein the fixing member 14 can be a bone needle, and the affected bone joint positioning block u can be fixed to the affected bone joint 18 by more than one bone needle, and the affected bone joint positioning block 11 The curvature of the bottom surface is created by using the three-dimensional information of the virtual ideal bone joint. Therefore, the curvature of the bottom surface of the affected bone joint positioning block 11 can be firmly adhered to the curvature of the joint surface of the external bone joint of the affected bone. On the other hand, the affected bone joint positioning block 11 can be composed of a plurality of pieces, and the parts 8 20 200936112 have a mechanism such as a card to achieve an easy combination. The milling cutter 12 is disposed within the central aperture 15 for cutting a degraded or damaged region of the affected bone joint 18 in the central aperture 15. 5 ❹ 10 15 ❹ The guiding device 13 is set at a predetermined position, and the sharp knife 12 can be maintained at a predetermined angle with the upper surface of the affected bone joint positioning block 11 and according to preset information. The sharp knife 12 is guided to rotate along the intermediate hole 15, and the guiding device 13 can operate the milling cutter 12 within a predetermined depth and prevent the cutting depth of the sharp knife 12 from being too shallow or too deep. The milling cutter 12 completely removes the degraded or damaged area of the affected bone joint 18 in the central hole 15, and the guiding device 13 can control the depth of the cutting and milling hole 16 caused by the milling cutter to be the same as the corresponding artificial joint 17 The bottom surface of the cutting and milling hole 16 is completely engaged with the corresponding bottom surface of the artificial joint 17 to achieve the purpose of further stabilizing the manual closing 17 . Among them, the milling cutter 12 has the characteristics of a heavy cutting edge, and in order to avoid temperature damage to the bone tissue during cutting, the speed, feed amount and torque of the milling cutter 12 during cutting are all set. It can be seen from the above that the achievable effect of the present invention is that the artificial joint is made more in line with the patient's own high requirement for the degree of adhesion of the bone and joint surface, so as to achieve the goal of artificial joint customization, and reduce the patient's After replacing the artificial joint, there is a problem of maladaptation, and it does not cause the use of standardized artificial joints. It is common to remove the problem of normal bones in the affected bone joints, and with the setting of the replacement device, the affected bone joints after resection The cutting and milling holes can be matched with the customized artificial joints, so that it is more convenient to replace the artificial joints, and the patient can also reduce the discomfort when replacing the artificial joints. 9 20 200936112 Therefore, the present invention can solve the troubles and inconveniences of the use and structure of the user, and file a patent application according to law. The above-mentioned components of the present invention are for illustrative purposes only and are not intended to limit the scope of the patent application of the present invention. Other equivalent component replacements are also covered by the scope 5 of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a flow chart of a first preferred embodiment of the present invention; FIG. 1B is a flow chart 5 of a second preferred embodiment of the present invention; 2 is a perspective view of a third preferred embodiment of the present invention; a third view is a perspective view of a third preferred embodiment of the present invention, showing a state of use of the present invention; and a fourth figure is a third comparison of the present invention. A perspective view of a preferred embodiment, which shows that the cutting and milling hole caused by the invention on the affected bone joint can be completely engaged with the bottom surface of the artificial joint. [Main component symbol description] Bone joint positioning block 11 Milling cutter 12 Guide device 13 15 固定 Fixing member 14 Middle hole 15 Cutting and milling hole 16 Completion joint 17 Bone joint 18 11