201242585 々、發明說明： 【發明所屬之技術領域】 本發明係有關一種個人化骨板之製造方法，特別是指一種 可準確配合骨骼曲面之個人化骨板製造方法，其兼具固定位置 精確、、減少臨發狀況之發生及降低醫療糾紛等優點1功效。 【先前技術】 …傳統的骨科手術，醫生藉由病患骨_ x光或電腦斷層 造影(computed tomography，簡稱CT)掃描所得之CT夢後决俨 知骨折位置，進而判斷骨板固定之位置。 &诼术件 雖然X光或CT影像可精確的分析病患骨骼骨折之位 但傳統的骨板固定手術中，仍存在下列缺. 於有誤$。習知骨板係具有二定之規格，在固定 212 ϊ病患骨絡之外形曲面，利用1具將骨板彎折 :而進行骨板之彎折’在實施上仍會產生一定之;差醫= …法達到良好的固定效果或造成病患不適，嚴 手術之部位為腿部，則可能使得手術過後i 成行動上較不協調）；如 ί ϋ曲Ϊ並固定於—骨絡92之骨折位置921後，與骨 t容易產生卿:s秘_定效果。 ί容: ί二ί,ίϊ出f i于調整；由於骨板之彎 符合，則需再次㈣調整，與之=曲面 時之===目對，，相對增加了=風險:手術 好的固定效果，嚴重ί甚生誤差’無法達到良 和響病患復原狀況，容易引發醫療 201242585 糾紛。 Μ破壞骨板品質。習知骨 整，骨板表面容易因蠻狀,4 /折之方式來達到調 質。 谷勿1·4 <折過程而糟到破壞，進而影響骨板之品 【發日::容^必要研發新方法，以解決上述缺點及問題 呈固的在於提供—種個人化骨板之製造方法，其兼 i功效，發狀況之發生及降低¥療糾料優點 高及基解私知技術加卫易有誤差'手術臨發狀況機率 南及導致醫療糾紛等問題 之製解述問題之技術手段係提供—種個人化骨板 表拉方法，其包括下列步驟： 加:、準備步驟：準備一 CT片掃描設備、一處理裝置、一 質骨板，有複數《骨板固定 1置及脫孤裝置，魏 #y_掃私步驟.利用5玄ct片掃描設備對一預定之人體部 ，仃電騎層造影掃描，以取得複數張斷面影像 影像係包括一骨骼斷面； 叫 二、立體影像成形步驟：以該處理裝置讀入複數張斷面影 像，進而建構出一 3D立體骨骼資訊； 四、骨骼實體模型製作步驟：將該3D立體骨骼資訊輸出 至該加工裝置，製作出一骨骼實體模型； 五、、製作骨板蠟形步驟：將一蠟質骨板置於該骨骼實體模 型上，並以該加熱裝置進行加熱，使該蠟質骨板軟化而貼合於 該骨骼實體模型上’在冷卻後取下，成為一客製化骨板之模型； 六、製造客製化骨板步驟：利用該脫蠟鑄造裝置對該客製 化骨板之模型進行翻製，製造出一客製化金屬骨板，該客製化 金屬骨板在進行表面處理後即可使用於人體之骨骼。 本發明之上述目的與優點，不難從下述所選用實施例之詳 細說明與附圖中，獲得深入瞭解。 201242585 茲以下列實施例並配合圖式詳細說明本發明於後： 【實施方式】 如第一圖所示，本發明係為一種個人化骨板之製造方法， 其包括下列步驟： —、準備步驟11 :如第二圖所示，準備一 CT片掃描設備 2〇、一處理裝置30、一加工裝置40、一螺·質骨板62、一加熱 裝置81及一脫蠛鑄造裝置82，該蠟質骨板62係具有複數蠟 質骨板固定孔621。 二、掃描步驟12 ··利用該CT片掃描設備20對一預定之 人體部位進行電腦斷層造影掃描，以取得複數張斷面影像51， 每一斷面影像51係包括一骨骼斷面；如第三、第四及第五圖 所示’利用該CT片掃描設備20對腿部91之骨骼92上之骨折 位置921 ’進行一預定範圍W之電腦斷層造影，進而取得複數 張斷面影像51(該斷面影像51係顯示骨骼與骨髓，肉與肉以 外之部份係未標示說明）。 三、立體影像成形步驟13 :以該處理裝置30讀入複數張 斷面影像51 (根據影像灰階度，判斷肉、骨骼與骨髓之輪廓）， 進而建構出一 3D立體骨骼資訊52 ;如第六圖所示，該處理裝 置30讀入複數張斷面影像51後，係建構出該3D立體骨路資 訊52,且該3D立體骨骼資訊52係包括一骨折位置資訊521。 q、霄聆頁菔棂型褽作步驟Η :將該3D立體骨骼資訊52 輪出至該加工裝置40 ,製作出一骨骼實體模型61 ;如第七圖 所示，該加工裝置40依該3D立體骨骼資訊52而加工f 該骨骼實體模型61。 五、製作骨板躐形步驟15 :如第人及第九圖所示 一 徵質骨板62置於該骨熟實體模型61上’並以該加 ，行加熱’使該《骨板62軟化而貼合於該她實體^ ’在冷卻後取下’成為—客製化骨板之模型62八； 製造客製赠板步驟16 :如第十11所*，利用簡 喂鑄造裝置__鱗板之翻㈣妨崎 201242585 =為一般常用技術，故不在此詳述），製造出一客製化金屬骨 f 70 ’該客製化金屬骨板7〇在進行表面處理後即可使用於人 體之骨骼92。 如第十一圖所示，翻製出之該客製化金屬骨板70，1俜 ^有複數_孔及-靠合曲面72 ;該靠合曲面72係用 1 余、人，之真實骨骼92之曲面貼合，再利用複數骨釘73穿過複 文固疋孔71而將該客製化金屬骨板7〇固定於骨骼92上。 如第十二、第十三A、第十三B及第十三C圖所示，在進 f客製化金屬骨板70之固定時，先將該客製化金屬骨板7〇 罪口/1^於人體之真實骨路92上（如第十三B及第十三c圖所 不’该靠合凹部72之曲面變化與人體之真實骨骼92之曲面完 全貼合）’再以複數個骨釘73分別穿過複數個固定孔71而鎖 入該骨路92中’將該客製化金屬骨板7〇固定於該骨絡92上， 達到固定該骨折位置921之目的。 更詳細的說，每個人的骨骼92尺寸與曲面皆有一定的不 同（例如.大人與小孩、男人與女人，在骨骼92尺寸上皆有一 定的差距）；而本發明可依不同之使用者，製出與使用者真 骨絡92尺寸完全相同之錄實體模型61，再依該倾實體模 型61上之曲賴化’翻製出可完全配合之該客製化金屬骨板 70 ’依據個人之骨骼曲面變化而量身訂作，對應各種不 絡92曲面，達到精確的配合。 如第十四A、第十四B、第十四〇第十五a、第十五B 第十五c圖所示’假設-第一病患之骨胳92A及一第 骨絡92B係具林同之尺寸及曲面魏，經由本發明之個I 骨板之製造方法分別製出-第一病患之客製化金屬骨板 及-第二病患之客製化金屬骨板70B後，該第一病患之 金屬骨板70A係完全貼合於該第一病患之骨絡92A上而 二病患之客製化金屬骨板70B係完全貼合於該第二病患^骨 路92B上。 另外，關於該加工裝置40，其射為一般之電腦數值控 201242585 制（Computer Numerical Control，簡稱 CNC)工具機或快速 成型（RapidPrototyping，簡稱RP)機；而該客製化金屬骨板 7〇之材質係可為不鏽鋼、鈦等。 u 關於该客製化金屬骨板70之表面處理，係需使該客製化 金屬骨板70之表面達到一定之光滑度，始可固定於乂體之骨 絡92 ;另外’該客製化金屬骨板7〇之表面處理，需符合優艮 產品製造規範(Good Manufacturing Practice，簡稱 GMP)之 認可。 θ 綜上所述，本發明之優點及功效可歸納為： [1 ]固疋位置精確。習知骨板利用弯折之方式來達到與骨 骼之配合，在實施上仍會產生一定之誤差；而本發明之客製化 金屬骨板70係依據病患之骨骼曲面變化而製作，可穿令诳病 患之骨路相配合，具有岐位置精確之伽^ ^全_ [2] 減少臨發狀況之發生。習知骨板之彎折容易產生誤 差’在手術時之臨發狀況機率也相對提高，不但延誤手術進行 時間’也相對提高了手術之風險；而本發明之客製化金屬骨板 70依據病患之骨路曲面製作而成，有效降低配合上的誤差， 減少臨發狀況之發生，也相對的降低了手術時間及風險。 [3] 降低醫療糾紛。習知骨板容易產生誤差，無法達到良 好的固定效果，嚴重時甚至影響病患復原狀況，容易引發醫療 糾紛；而本發明所製作出之該客製化金屬骨板7〇，係完全與 病患之骨骼92曲面完全配合，可達到良好的固定效果，降 醫療糾紛的發生。 以上僅是藉由較佳實施例詳細說明本發明，對於該實施例 所做的任何簡單修改與變化，皆不脫離本發明之精神與範圍。 以上詳細說明，可使熟知本項技藝者明瞭本發明的確可 達成則述目的，實已符合專利法之規定，爰提出發明專利申 【圖式簡單說明】 第一圖係本發明之個人化骨板之製造方法之流程示意圖 第一圖係本發明之準備步驟之示意圖 201242585 第三圖係本發明進行掃描之示意圖 第四圖係本發明掃描範圍之示^圖 第五圖係本發明之斷面影像之$意圖 第六圖係本發明之3D立體骨骼資訊之示音 第八圖係本發狀製作骨板獅挪轉 第九圖係本發明之製作骨板_步雜序 = 第十圖係本發明翻製客製化骨板之示意圖’、心圖 系本發明之錄實體模型製作之示ill 圖 係本發明之客製化f板與f絡之組裝示 本發明之客製化骨板固定於骨路“意圖 第十二B圖係沿Π-Π剖面線之剖視示意 第十一圖係本發明之客製化骨板之示意 一 —.-.μ 圖 第十三C圖係沿ΠΜΠ刮面線之剖視示意圖 ^四Α係本發明之第一病患之骨絡之示意圖 c發明之第一病患之骨板固定示意圖 四係係沿IV-IV剖面線之剖視示意圖 =^五A係本發明之第二病患之骨路之示意圖 係本發明之第-病患之骨板固定示意圖 :卞五C係係沿V -V剖面線之剖視示意圖 2六圖剌知技術之骨板與骨顧定之示意圖 第十七A圖係沿VI-VI剖面線之示意圖 ^ ^十七B圖係沿VE-VII剖面線之示意圖 【主要元件符號說明】 12掃描步驟 14骨骼實體模型製作步驟 16製造客製化骨板步驟 30處理裝置 51斷面影像 61骨骼實體模型 621蠟質骨板固定孔 11準備步驟 13立體影像成形步驟 15製作骨板蠟形步驟 20 CT片掃描設備 40加工裝置 52犯立料路資訊 62蠟質骨板 201242585 62A客製化骨板之模型 70客製化金屬骨板 70A第一病患之客製化金屬骨板 70B第二病患之客製化金屬骨板 71固定孔 72靠合凹部 73骨釘 82脫蠟鑄造裝置 92骨骼 92B第二病患之骨骼 100習知骨板 81加熱裝置 91腿部 92A第二病患之骨骼 921骨折位置 S間隙201242585 々, the invention description: [Technical field of the invention] The present invention relates to a method for manufacturing a personalized bone plate, and more particularly to a method for manufacturing a personalized bone plate that can accurately match a bone surface, which has both a fixed position and an accurate position. , to reduce the occurrence of temporary conditions and reduce medical disputes and other advantages 1 effect. [Prior Art] ... Traditional orthopedic surgery, the doctor diagnosed the fracture position by CT scan of the patient's bone x-ray or computed tomography (CT) scan, and then determined the position of the bone plate fixation. & 诼 件 Although X-ray or CT images can accurately analyze the location of bone fractures in patients, the traditional bone plate fixation surgery still has the following defects. The conventional bone plate system has two specifications, and the shape of the curved surface of the patient is fixed in 212 ϊ, and the bone plate is bent by one: the bending of the bone plate is still performed in the implementation; = ... The method achieves a good fixation effect or causes discomfort to the patient. The strict surgical site is the leg, which may make the action i are less coordinated after the operation; if the ί ϋ Ϊ Ϊ 固定 固定 固定 固定 固定 固定 固定 固定 固定 固定 固定After the position 921, it is easy to produce a clear effect with the bone t.容容: ί 二ί, ϊ ϊ 于 于 ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; , serious ί very error 'can not reach the recovery of patients with good and sick, easily lead to medical 201242585 dispute. Μ Destroy the quality of the bone plate. Conventional bones, the surface of the bone plate is easy to achieve tempering due to the sturdy shape, 4 / fold way.谷勿1·4 < folding process and damage to the destruction, and then affect the bone plate products [Day:: Rong ^ necessary to develop new methods to solve the above shortcomings and problems are solid is to provide - a personalized bone plate The manufacturing method, its i-effect, the occurrence of the hair condition and the reduction of the advantages of the treatment and the correction of the material, and the knowledge of the privately-known technology, and the susceptibility to error, the problem of the problem of the surgical dying condition and the problem of medical disputes. The technical means provides a personalized bone plate stretching method, which comprises the following steps: Adding: preparing steps: preparing a CT scanning device, a processing device, a bone plate, and a plurality of bone plate fixing 1 and Separation device, Wei #y_Sweeping step. Using a 5 Xuan ct scanning device for a predetermined body part, a squatting layer scan to obtain a plurality of cross-sectional image systems including a skeletal section; Stereoscopic image forming step: reading a plurality of cross-sectional images by the processing device to construct a 3D stereoscopic bone information; 4. Creating a skeleton physical model: outputting the 3D solid skeleton information to the processing device to create a The skeletal solid model; 5. The method of making a bone wax: placing a waxy bone plate on the solid model of the bone, and heating with the heating device to soften the waxy bone plate and conform to the bone entity The model is removed after cooling and becomes a model of a customized bone plate. 6. Manufacturing a customized bone plate step: using the dewaxing casting device to reproduce the model of the customized bone plate, and manufacturing A customized metal plate, which can be used for the bones of the human body after surface treatment. The above objects and advantages of the present invention will be readily understood from the following detailed description of the preferred embodiments illustrated herein. 201242585 The present invention will be described in detail below with reference to the following embodiments: [Embodiment] As shown in the first figure, the present invention is a method for manufacturing a personalized bone plate, which comprises the following steps: - Preparation steps 11: As shown in the second figure, a CT scanning device 2, a processing device 30, a processing device 40, a screw plate 62, a heating device 81, and a decoupling casting device 82 are prepared. The bone plate 62 has a plurality of waxy bone plate fixing holes 621. Second, scanning step 12 · Using the CT scanning device 20 to perform a computed tomography scan on a predetermined human body part to obtain a plurality of cross-sectional images 51, each of which includes a bone section; 3. The fourth and fifth figures show a computerized tomography of a predetermined range W using the CT scanning device 20 for the fracture position 921 on the bone 92 of the leg 91, thereby obtaining a plurality of cross-sectional images 51 ( The cross-sectional image 51 shows bone and bone marrow, and the parts other than meat and meat are not marked. 3. Stereoscopic image forming step 13: reading, by the processing device 30, a plurality of cross-sectional images 51 (determining the contours of meat, bones and bone marrow according to the gray scale of the image), and constructing a 3D skeleton information 52; As shown in FIG. 6 , after the processing device 30 reads the plurality of cross-sectional images 51 , the 3D solid bone information 52 is constructed, and the 3D stereo bone information 52 includes a fracture position information 521 . q, 霄 菔棂 菔棂 褽 褽 Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η Η The solid skeleton information 52 is processed by the solid skeleton information 52. V. Making a bone plate shape Step 15: As shown in the first person and the ninth figure, a bone plate 62 is placed on the bone mature body model 61 'and heated by the addition, so that the bone plate 62 softens And attached to the entity ^ 'removed after cooling' becomes a model of the customized bone plate 62 eight; manufacturing custom gift board step 16: as in the tenth 11th *, using the simple feeding casting device __ scale The turning of the board (4) 崎崎201242585 = is a common technology, so it is not detailed here), to create a customized metal bone f 70 'The customized metal bone plate 7 〇 can be used in the human body after surface treatment Skeleton 92. As shown in the eleventh figure, the customized metal plate 70, 1俜^ has a plurality of holes and a matching curved surface 72; the curved surface 72 is made of more than one, human, real bones The curved surface of 92 is bonded, and the plurality of bone nails 73 are passed through the plurality of fixed nails 71 to fix the customized metal plate 7 to the bone 92. As shown in the twelfth, thirteenth, thirteenth and thirteenthth Cth, when the fixing of the customized metal plate 70 is performed, the customized metal plate 7 is first sinned. /1^ on the real bone path 92 of the human body (as in the thirteenth and thirteenthth cth diagrams, the curved surface of the recessed portion 72 completely conforms to the curved surface of the real bone 92 of the human body) The bone nails 73 are respectively inserted into the bone path 92 through a plurality of fixing holes 71. The customized metal plate 7 is fixed to the bone network 92 for the purpose of fixing the fracture position 921. In more detail, each person's bone 92 has a certain size and surface (for example, adults and children, men and women, there is a certain gap in the size of the bone 92); and the present invention can be different users , and the recorded physical model 61 having the same size as the user's true bone network 92 is produced, and then the customized metal plate 70 ' can be completely matched according to the melody on the tilting solid model 61. The skeletal surface changes and is tailor-made, corresponding to various types of curved surfaces, to achieve an accurate fit. As shown in the fourteenth A, fourteenth B, fourteenth fifteenth a, fifteenth fifteenth fifteenth c diagram, 'hypothesis - the first patient's skeleton 92A and one diatom collateral 92B Lintong's size and curved surface Wei, through the manufacturing method of the I bone plate of the present invention, respectively, after the customized metal plate of the first patient and the customized metal plate 70B of the second patient, The first patient's metal plate 70A is completely attached to the first patient's bone network 92A, and the second patient's customized metal plate 70B is completely attached to the second patient's bone road. On 92B. In addition, regarding the processing device 40, it is a general computer numerical control 201242585 (Computer Numerical Control, referred to as CNC) machine tool or Rapid Prototyping (RP) machine; and the customized metal plate 7 The material can be stainless steel or titanium. u Regarding the surface treatment of the customized metal plate 70, the surface of the customized metal plate 70 needs to have a certain degree of smoothness, and can be fixed to the skeleton 92 of the carcass; The surface treatment of the metal plate 7 is subject to the approval of Good Manufacturing Practice (GMP). θ In summary, the advantages and effects of the present invention can be summarized as follows: [1] The solid position is accurate. The conventional bone plate utilizes the method of bending to achieve the cooperation with the bone, and still has a certain error in implementation; and the customized metal plate 70 of the present invention is made according to the change of the bone surface of the patient, and can be worn. In order to match the bone path of the sputum patient, it has the precise position of the 岐 ^ ^ _ [2] to reduce the occurrence of temporary conditions. The bending of the known bone plate is prone to error 'the probability of the temporary condition during the operation is relatively increased, not only delays the operation time of the operation' but also increases the risk of surgery; and the customized metal plate 70 of the present invention is based on the disease. The bone surface of the affected bone is made, which effectively reduces the error in the fitting, reduces the occurrence of the temporary condition, and relatively reduces the operation time and risk. [3] Reduce medical disputes. Conventional bone plates are prone to errors, fail to achieve a good fixation effect, and even affect the patient's recovery status in severe cases, which may easily lead to medical disputes; and the customized metal plate 7 produced by the present invention is completely ill. The curved surface of the affected bone 92 is fully matched, which can achieve a good fixation effect and reduce the occurrence of medical disputes. The present invention has been described in detail by the preferred embodiments of the present invention. The above detailed description will enable those skilled in the art to understand that the present invention can be achieved, and has fulfilled the requirements of the patent law, and has filed a patent application [simplified description of the drawings]. The first figure is the personalized bone of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS The first diagram is a schematic diagram of the preparation steps of the present invention 201242585 The third diagram is a schematic diagram of the scanning of the present invention. The fourth diagram is the scanning range of the present invention. The fifth diagram is the section of the present invention. The sixth image of the image is the eighth image of the 3D stereoscopic bone information of the present invention. The hairline lion is rotated to the ninth figure. The bone plate of the present invention is _ step sequence = tenth system The schematic diagram of the invention of the customized bone plate of the present invention, the heart diagram is the production of the physical model of the present invention. The figure of the invention is the assembly of the customized f-plate and the f-system. The customized bone plate of the invention is shown. Fixed to the bone path "Intent to the twelfth B-picture along the Π-Π section line shows the eleventh figure is the schematic of the customized bone plate of the present invention -.-.μ Figure 13th C picture A cross-sectional view along the squeegee line Schematic diagram of the bone formation of the first patient c. Schematic diagram of the fixation of the bone plate of the first patient of the invention. Fig. 4 is a cross-sectional view of the IV-IV section line = ^五A is the bone path of the second patient of the present invention. The schematic diagram is a schematic diagram of the fixation of the bone plate of the first patient of the present invention: a schematic cross-sectional view of the V-V section line along the V-V section of the fifth line of the 卞5 剌 技术 技术 骨 第 第 第 第 第 第 第Schematic diagram along the VI-VI section line ^^17B diagram along the VE-VII section line [Main component symbol description] 12 scanning step 14 skeleton physical model making step 16 manufacturing customized bone plate step 30 processing device 51 Section image 61 skeleton solid model 621 waxy bone plate fixing hole 11 preparation step 13 stereoscopic image forming step 15 production of bone plate wax shape step 20 CT piece scanning device 40 processing device 52 erecting material information 62 waxy bone plate 201242585 62A Customized bone plate model 70 customized metal plate 70A first patient customized metal plate 70B second patient customized metal plate 71 fixed hole 72 hinged recess 73 bone nail 82 off Wax casting device 92 bone 92B second patient's bones 100 learned bone 81 patients of skeletal heating apparatus 92A of the second leg 91 a gap 921 S fracture site