201215380 六、發明說明： 【發明所屬之技術領域】 本發明係關於-種血管支架之加工方法，特別是 指-種利用容易取得之原材料及加卫機械，製造出内 應力小且表面平滑具富鉻化及高潔淨度、抗钱 斥性之血管支架之加工方法。 【先前技術】 所帶當來今的人广二的生活水準提升’ A部分人忽略高油脂 、;矢'丙而國人十大死因中，與心血管有關之 :病就排名在前面’究其原因不外乎與飲食、肥胖、 缺乏運動有關’而有關血管之阻塞最有效方译 ==血管支架:血管病灶，而最有效的二 加、：田乍’阻塞的血官直接加以疏通，利用血管支 =為取*使用的治療方式，又該作為心臟侵入性治 管支架係為-種管形網狀結構，植入人 暢通二乍邻分使其具有支撐血管，保持血管内血流 架之二：方而心血管支架撐起和擴張方法，按血管支 藉由二Γ’則有球囊擴張式和自膨脹式兩大類， 管供應丄I保持血管内血流的暢通，增進原病灶血 作為：严：和養分之能力，然而由於血管支架主要是 血管壁保持其暢通和開放，所以便需能適應 201215380 血官内不同結構和特徵、考慮到其支撐強度好的組織 相容性、小面積金屬覆蓋率會影響到血管開閉窗之網 孔叹计及小的軸向縮短率或其他等各種因素，而一般 在血管支架之設計構思，主要是利用支架網目對也管 壁的支據和保持其血液流動暢豸，如果從血管支架之 生物力學的特性來考量其應具有抗血管回彈力、釋放 後其長度保持不變及軸向縮短率要小，軸向柔韌性要 子擴張率π、未釋放㈠屋合）狀態需有較小外輪廟、 通過側枝血管時要容易和貼壁性、釋放後對企管壁之 知傷小 < 疲勞性高，按一般歐美先進國家之血管支 木-胚料製造過程，都是藉由拉伸和擠製及二次真空 退火處理之三者同步加工完《，其二次退火 士 anneal lng )將原材料加熱到一定溫度並保持足夠201215380 VI. Description of the Invention: [Technical Field] The present invention relates to a method for processing a blood vessel stent, and particularly to a raw material and an auxiliary machine which are easily obtained, and which have a small internal stress and a smooth surface. A method of processing chrome, high cleanliness, and anti-rejection vascular stents. [Prior Art] The life standard of the people who have come to the present is enhanced. 'Part A people ignore high fat, and 'B' and the top ten causes of death of the Chinese people are related to cardiovascular: the disease is ranked in front. The reason is nothing more than diet, obesity, lack of exercise. And the most effective vascular obstruction == vascular stent: vascular lesions, and the most effective two plus,: Tian Hao 'blocked blood official directly to dredge, use Vascular branch = the treatment method used for taking *, and the invasive tubular stent is a tubular network structure, which is implanted into the human sputum to support the blood vessels and maintain the blood flow in the blood vessel. The second: the cardiovascular stent support and expansion method, according to the vascular branch by the two Γ ', there are two types of balloon expansion and self-expansion, the tube supply 丄 I to maintain the smooth flow of blood in the blood vessels, enhance the original lesions Blood as: strict: and the ability of nutrients, however, because the vascular stent is mainly the vascular wall to maintain its smooth and open, so that it needs to be able to adapt to the different structures and characteristics of the 201215380 blood official, considering its tissue strength for good tissue compatibility Small area metal coverage will affect the mesh opening and closing of the blood vessel opening and closing window and small axial shortening rate or other factors, and the design of the vascular stent is generally based on the use of the stent mesh and the wall. According to and maintain the smooth flow of blood, if the biomechanical properties of the vascular stent are taken into consideration, it should have anti-vascular resilience, the length of the vascular stent should remain unchanged, and the axial shortening rate should be small, and the axial flexibility should be expanded. The rate of π, unreleased (a) housing) requires a small outer wheel temple, easy and adherent when passing through the side branch blood vessels, and small damage to the enterprise wall after release. High fatigue, according to the blood vessels of the advanced European and American countries The wood-binder manufacturing process is completed by three processes of stretching and extrusion and secondary vacuum annealing. The secondary annealing is used to heat the raw materials to a certain temperature and keep enough.
k間’然後緩慢冷卻H 7卩改善材料的結晶粒的組織和塑 性和韋刃性’使化學成分 勺勾化，去除加工之殘餘應力 和内應力或其益法褚地从仏 ^ /去預期的物理性，國内對於該等原材 枓之取得不易，且兮望 δΛ專加工經驗缺乏，又礙於國外進 县L 用在其用途之責任問題。因此，假若以國内 :件之材料作為原材料及加工機械，以解決習用 之缺失，並藉此能由國内 ^,,ν ^ _内自仃生產，而提供富鉻化及 知格低廉且能符合病患 吓而之血管支架之加工方法。 【發明内容】 201215380 為解決上述之現有技術不足之處，本發 提供-種加工方式以改良血管支架之加工方法目= 克服現有技術中之難處。 為達上述之目的，本創作係提供一種血管支架之 加工方法，其至少包括以下步驟：先原材料選擇準 觜人為CAE力學极擬和最適化設計之caj)設計模 型，再次為原材料檢驗之毛細管車削與拋光；以數控 雷射刀°】加工，之後以超音波振動酸洗除屑、化學除 油巧洗、去氧化皮層、清洗；而後，將血管支架電 解拋光’ β洗，中和；清洗；鈍化；復對，血管支架 清洗烘乾；再將血管支架滅菌處理；最後，即可 支架半成品。 而藉此設計，可易於取得之原材料及加工技技 術’且此製造出⑨質優良價格低且内應力小，表面平 滑且富鉻化，高淨、抗蝕性，低排斥性之血管支架之 加工方法，符合創新新穎、進步與使用者所需，足見 其加工增益處。 【實施方式】 為利貝審查員瞭解本發明之發明特徵、内容與 優點及其所能達成之功效，IU#本發明配合附圖，並 以實％例之表達形式詳細說明如下，而於文中所使用 之圖式#主曰僅為示意及輔助說明書之用，未必為 201215380 本發明實施後之真實比例與精準配置，故不應就所附 之流程與配置關係褐限本發明於實際實 範圍，合先敘明。 請參閱第-圖所示，係為本發明之加工方 程方塊圖，本發明之血管；恕+上 又汆之加工方法於一最適化 成 :了施例中，係至少包括以下之步驟：原材料選擇準 ⑽5又什模型2、毛細管車削與拋光3、數控雷 :切割加工4、超音波振動酸洗除屑5、化學除油5卜 :洗52、去氧化皮層53、清洗54、血管支架 抱以、清洗、中和62、清洗63、聽64、血管 支架清洗供乾7、血管支架滅菌處理8、血管支架半 σσ 月』述之原材料選擇準们，&於材料力學與物理 特性皆與血管支架其生物相容性、X射線（X-ray ) MRI (magnetic resonance imaging) ^ 可視性、徑向回彈_性、可輸送性、壓握後的外輪 '變化及能否長期保持完整性有其直接關係，而血管 支木依其不同擴張方式而對於材料的要求也有其區 ^ _以球囊擴張支架而論，因須具有防止彈性回縮之 車乂门的彈’生模置’同時需在-定膨脹壓力下將其擴張 ，且=壓握在球囊上；而以自膨脹式支架而論’其材 ;\、丨為要有較大變形恢復能力，使在輸送系統内和釋 放，都保持在超彈性範圍内’因此，於自膨脹式血管 支架係以鎳鈦形狀記憶合金為主，而球囊擴張式支架〖 201215380 可加工之原材料主要以經二次退火狀態之w π醫 用不錄鋼，但並不以此限制本發明，其亦可為始絡合 金或f他任何可作為支架之原材料，都屬於本發明的 保護範圍；本發明其原材料選擇準備係以二次退火狀 態之316L醫用不錄鋼，其内表面不需表面處理，而 外表面則需經過機械拋光，且符合國際IS02604-4標 準，但並不以此限制本發明，凡是任何符合其特性之 >各種原材料，都屬本發明的保護範圍。 别述之CAD設計模型2，此步驟係利用電腦輔助 設計CAD (C_uter Aided Design)將支架結構成 圖形*該電腦辅助設計係配合CAE I腦輔助工程 (Computer Alded Engineering)，利用其分析值可 作最適化分析，或改變設計模型之形狀、大小、厚度、 尺寸等以達強化其強度之目的之CAE力學模擬和最 適化設計21。 > 前述之毛細管車削與拋光3，此步驟基本上係採 使用咼精密之車削加工法及精密機械拋光加工法，因 國外血官支架之毛細管製造技術並没有如本發明之 加工流程，其在加丄時間上雖稍為延長，但卻有加工 時之内應力較小優點’本發明為了將其原材料前後管 土同。度控制在合理範圍（如土 〇 · 〇 1 5mm )以内，所以最 好使用南精密度之四軸综合車床加工及高精密度拋 光加工機台，該毛細管車削與拋光3步驟，係配合原 材料檢驗31。 201215380 前述之數控雷射切割加工4，本發明係利用雷射 束切割材料，藉由原材料吸收光能，光能轉變為熱能 2原材料加熱熔融氣化’最後將原材料去除或破壞; 本發明血管去举Rl p t , ’、尺寸微小，一般機械加工方法很難 加工出複雜的企管支架網孔形狀，而雷射光束因其在 加工過程中且有&丨 、有j而一致的切縫寬度、熔渣少、加 =表面品質好、熱影響微小、易於控制等優點，其並 利用電腦辅輯圖軟體設計出血管支架外表 面展開圖，之後導入雷射切割機做前置路徑處理，且 f擬其切割路徑，修改程式槽頭和#尾部份之程式語 二最後將6又疋完成後之路徑文件輸人到雷射切割機 行力m本發”去除原材料可自動脫落 $疋利用超音波振動職，對於去除較大面積材料， 割路接之設計’係將該較大面積材料分段切割成 同時為保濩透鏡免於污染並吹走切割區底部之 …-，本發明係採用同軸吹出各種適合材料之 屬材料時則使用活性氣體’以使其與熾熱金屬 :立氧化放熱反應，提高切割速度，對於非金屬材料 2分金屬材料，則使用壓縮空氣或情性氣體，以清 :…化和蒸發材料並抑制其過度燃燒，本發明則採用 ^噴出通水’同時抑制切割區過度燃燒，至於 二切割機的參數設定範圍包含有：⑴脈沖頻率 0· 13 ’（4)工作能量/w: 01 — 0.5k between 'then slowly cooling H 7 卩 improve the crystal structure and plasticity of the material and the edge of the blade' to make the chemical composition scoop, remove the residual stress and internal stress of the process or its benefits from the 仏 ^ / to anticipation The physical nature of the domestic production of these raw materials is not easy, and the lack of experience in the processing of δΛ special processing, but also the responsibility of foreign use of the county L for its use. Therefore, if domestic materials are used as raw materials and processing machinery to solve the lack of custom, and thus can be produced by domestic, ν ^ _, and provide chrome-rich and low-cost It can meet the processing method of the blood vessel stent which is scared by the patient. SUMMARY OF THE INVENTION 201215380 In order to solve the above-mentioned deficiencies of the prior art, the present invention provides a processing method for improving the processing method of a blood vessel stent. It is to overcome the difficulties in the prior art. In order to achieve the above purpose, the present invention provides a method for processing a blood vessel stent, which comprises at least the following steps: firstly selecting a raw material to select a caj) design model for CAE mechanics and an optimal design, and again performing capillary turning for raw material inspection. And polishing; processing with a numerically controlled laser knife °, then ultrasonic cleaning with acid pickling, chemical degreasing, descaling, cleaning; then, the vascular stent is electropolished 'β washing, neutralization; cleaning; Passivation; re-pairing, vascular stent cleaning and drying; sterilizing the vascular stent; finally, the stent can be semi-finished. By this design, the raw materials and processing technology that can be easily obtained', and the manufacture of the vascular stent with good quality and low price, small internal stress, smooth surface and rich chrome, high purity, corrosion resistance and low repellency The processing method is in line with the innovation, novelty, progress and user needs, which can be seen in the processing gain. [Embodiment] For the Leibe examiner to understand the features, contents and advantages of the invention, and the effects thereof, the present invention is described in detail with reference to the accompanying drawings, and in the form of the actual example, in the text The schematics used are only for the purpose of illustration and supplementary instructions. They are not necessarily true ratios and precise configurations after the implementation of the invention in 201215380. Therefore, the relationship between the attached process and the configuration should not be limited. , first and foremost. Please refer to the figure - figure, which is a block diagram of the processing equation of the present invention, the blood vessel of the present invention; the processing method of the prior art is further optimized: in the embodiment, the method includes at least the following steps: raw material selection Quasi (10) 5 and model 2, capillary turning and polishing 3, CNC mine: cutting processing 4, ultrasonic vibration pickling and removing debris 5, chemical degreasing 5 Bu: washing 52, descaling layer 53, cleaning 54, blood vessel support , cleaning, neutralization 62, cleaning 63, listening 64, vascular stent cleaning for dry 7, vascular stent sterilization 8, vascular stent half σσ month, the raw material selection, & material mechanics and physical properties are related to blood vessels The biocompatibility of the stent, X-ray MRI (magnetic resonance imaging) ^ visibility, radial rebound _ sex, transportability, change of the outer wheel after the crimping and the long-term integrity The direct relationship, and the vascular branch tree has its own requirements for the material according to its different expansion methods. _ In the case of a balloon-expanding stent, it is necessary to have a bullet-shaped mold that prevents elastic retraction. Need to be under the constant expansion pressure Expand it, and = press on the balloon; and in the case of self-expanding stents; \, 丨 to have greater deformation recovery, so that in the delivery system and release, remain super elastic In the range, therefore, the self-expanding vascular stent is mainly composed of nickel-titanium shape memory alloy, and the balloon-expandable stent 〖201215380 can process raw materials mainly in the second annealing state of w π medical unrecorded steel, but The invention is not limited thereto, and it may also be a starting material of the alloy or any material which can be used as a support, and belongs to the protection scope of the present invention; the raw material selection preparation of the present invention is 316L medical treatment in a secondary annealing state. Recording steel, the inner surface does not need surface treatment, and the outer surface needs to be mechanically polished, and conforms to the international IS02604-4 standard, but does not limit the invention, and any raw materials that meet its characteristics are The scope of protection of the present invention. In addition to the CAD design model 2, this step uses the computer-aided design CAD (C_uter Aided Design) to frame the support structure. * The computer-aided design department cooperates with CAE I Computer Aid Engineering (Computer Alded Engineering), and its analysis value can be used. Optimum analysis, or change the shape, size, thickness, size, etc. of the design model to achieve CAE mechanical simulation and optimization design for the purpose of strengthening its strength. > The aforementioned capillary turning and polishing 3, this step basically adopts the precision turning processing method and the precision mechanical polishing processing method, because the capillary manufacturing technology of the foreign blood official stent does not have the processing flow according to the present invention, Although it is slightly extended in the twisting time, it has the advantage of less internal stress during processing. The present invention is intended to have the same raw materials before and after the raw materials. The degree of control is within a reasonable range (such as soil 〇 15 mm), so it is best to use a four-axis integrated lathe processing and high-precision polishing machine for south precision. The capillary turning and polishing steps are combined with raw material inspection. 31. 201215380 The above-mentioned numerical control laser cutting processing 4, the invention uses the laser beam cutting material, the raw material absorbs the light energy, the light energy is converted into the thermal energy 2 raw material, the heating and melting gasification 'finally removes or destroys the raw material; the blood vessel of the invention goes Rl pt, ', the size is small, the general machining method is difficult to process the complex shape of the mesh hole of the enterprise, and the laser beam has a uniform slit width due to its & The advantages of less slag, addition=good surface quality, small thermal influence, easy control, etc., and designing the outer surface of the vascular stent by computer software, then introducing the laser cutting machine to do the front path processing, and f The cutting path is to be modified, and the program language of the program slot head and the #tail part is modified. Finally, the path file after the completion of the 6th and the completion is input to the laser cutting machine. The removal of the raw material can be automatically detached. In the case of sound wave vibration, for the removal of large-area materials, the design of the cut-off connection is to cut the larger-area material into sections at the same time to protect the lens from contamination and blow off the bottom of the cutting area. In the present invention, when the coaxial materials of various suitable materials are coaxially blown, the active gas 'is used to react with the hot metal: the oxidative exotherm to increase the cutting speed, and for the non-metallic material, the metal material is compressed. The air or the inert gas is used to clear and evaporate the material and inhibit its excessive combustion. In the present invention, the water is sprayed and the excessive combustion of the cutting zone is suppressed, and the parameter setting range of the second cutting machine includes: (1) pulse frequency 0· 13 '(4) Working energy / w: 01 — 0.5
Hz:2-4，（2)i#M/v:4〇〇_55〇，（3)j^/ms: U . (I 7 Π 1 λ / .、 201215380 則述之超音波振動酸洗除屑5，本發明其原材料 經數控雷射切割加工4後，再經壓電晶體之逆壓電效 應而產生振動頻率超過人類無法聽到範圍 所產生之超曰波，利用超音波由超音壓強和輻射壓強 所引起之機械作用’利用超音波在液體中傳播其質點 隨著聲波做相同頻率的振動’連續產生過壓和可使液 體拉裂空化作用（CAVITAT腦）衝擊波作用之負壓 現象作為清洗，由於清洗液接受超音波振動能量後產 生正負交變的衝擊波’該清洗過程是藉由空化氣泡之 裂痕產生大的音壓’使污物或毛屑、稜邊，從原材料 :面剝落形成間隙’而其間因反覆受到空化氣泡群的 :又入且又到曰壓之變化和其氣泡反覆收縮膨脹，將 藏在細縫或深孔的污物層輕易的剝落和清洗乾淨。 藉由超音波水浴振動去除因雷射高溫切 2 ’所產生之毛邊和切連桿上之溶澄，並將其供乾 浸入標準配製的酸液中以利於去除表面氧化層和直 他油污和髒物或其他各種物等；而該步驟進-步依序 =述之化學除油5ί、清洗52、去氧化皮層53 牛^ 54步驟，其中’於本實施例該化學除油5ί 步驟之配方及操作條件分別包括有·· 1、碳酸鈉 15-25 g/x^Hz: 2-4, (2) i#M/v: 4〇〇_55〇, (3) j^/ms: U. (I 7 Π 1 λ / ., 201215380) Ultrasonic vibration pickling After removing the chip 5, the raw material of the invention is processed by the numerical control laser cutting process 4, and then the piezoelectric wave has an inverse piezoelectric effect, and the vibration frequency exceeds the super-wave generated by the human inaudible range, and the ultrasonic wave is used by the ultrasonic pressure. And the mechanical action caused by the radiant pressure 'Using ultrasonic waves to propagate its mass in the liquid as the sound waves do the same frequency of vibration' continuously generates overpressure and can cause the liquid to crack cavitation (CAVITAT brain) shock wave action as a negative pressure phenomenon Cleaning, because the cleaning fluid receives the ultrasonic vibration energy, it produces a positive and negative alternating shock wave. 'The cleaning process is to generate a large sound pressure by cavitation bubble cracks' to make dirt or dander, edges, from the raw material: surface peeling The gap is formed, and the cavitation bubble group is repeatedly received: the change in the pressure and the change and the expansion and contraction of the bubble, and the dirt layer hidden in the slit or deep hole is easily peeled off and cleaned. Ultrasonic water bath vibration to remove high temperature due to laser Cut the resulting burrs on the burrs and cut-off rods, and dry them into the standard prepared acid solution to facilitate the removal of surface oxide layer and straight oil and dirt or other various things; Step-by-step = description of chemical degreasing 5 ί, cleaning 52, de-oxidation layer 53 牛 ^ 54 steps, wherein 'the chemical degreasing 5 步骤 step in the embodiment of the formula and operating conditions respectively include · · 1, carbonic acid Sodium 15-25 g/x^
2、氫氧化鈉 10-20 g/L 201215380 3、 磷酸鈉 15-25 g/ι ; 4、 乳化劑（〇M〇) 7-2〇ml/L.， 其控制溫度為25-30。。常溫之間；而時間為1(Μ5 分鐘（m i η ); h則述之去氧化皮層53步驟於本實施例之配方為： 1〇%稀硫酸’時間為10-15分鐘（min); 籲又其間所為之清洗52、54步驟中’則係以去離子水 沖洗數次並使用吹風機烘乾。 前述之血管支架電化學拋光6,本發明係將血 支架經前述之超音波振動酸洗除屑5及常溫化學隙 '月洗52、去氧化皮層53及清洗54後，即: ^本步驟之血管支架電化學減6，其係至少執行 次至數次’·其工作方式為將血管支架接於陽極，以〗 原金屬接於陰極，置於電解液中通上直流電 控制電解液中之㈣器起動，以利於電解液令之均^ :和溫度之掌控;以電解作用之反電鍍將血管支架々 :面金屬鐵移除，增加表面鉻金屬之量和控制品質之 取適化’血管支架表面將因此產生材料之消蝕 毛邊或毛屬及污物之作用，血管支架經電解拋 化1用後，其表面會發生兩種作用，其一為光澤 化，其一為表面平坦化；並且經電解拋光時會在血管 201215380 支架表面層生出鈍化層，同時因所含不同之金屬分 子，其移除速率也不相同，在其電解拋光之過程中表 面所含之鐵分子會被先移除，使得不銹鋼之表面所留 下之鉻刀子畺會被提咼，也就是鐵分子被析出，溶解 在電解液中，同時鉻元素是人體比較可接受的金屬物 •質，該過程為血管支架表面「富鉻化」反應，本發明 其電化學拋光可做次數在一次到三次以上，但並不以 鲁此限制本發明，舉凡任何次數，都屬本發明的保護範 圍内，該電解拋光目的在讓鉻分子或原子充滿血管支 架的表面層，造成表面生成三氧化二鉻的表面層，基 本該氧化層是可有效提升表面抗蝕能力。且在進行電 解拋光時，血官支架之表面層會被移去一層包含髒 污、油污、氧化層、雜質層、碳化層及内應力層等物 質，故其表面並非常平坦面。電解拋光將可使的表面 籲達到高度潔淨層和鏡面級的光澤。同時可去除支揮連 桿及連接環這兩個部份之細微組織的表面毛邊和溶 渣’因可提高表面平整度’並有效的降低血拴，並減 少臨床植入後之血管内膜增生與降低後續之發炎問 題，且提升與血管相容性與改善兩者療合效果，本發 明經電解拋光，更可去除因機械加工或材質内部所容 易產生之裂痕、消除内應力集中之問題、又可增加使 用壽命和提升材料疲勞性能；而本發明血管支架電化 201215380 學拋光6步驟其（電解拋光液）配方及使用量包括 有： 磷酸含量（85%)，使用量600-700 ml/L ; 硫酸含量（98%)，使用量為200-300 ml/L; 三氧化鉻使用量為80 g/L; 添加劑，使用量為10g/L ; 其操作條件係為.控制（電解拋光液）溫度為7 〇 _ 8 〇 C ’電壓控制在15-20VC 18V)，時間控制為2分鐘。 前揭可改變拋光電解液黏度及血管支架表面的 拋光品質與減少雜質敏感性之添加劑，於本實施例係 為乙二醇，但並不以此限制本發明，其亦可為可達到 該目的之任何添加劑，都屬本發明的保護範圍。 本發明該血管支架電化學拋光6步驟之後，進_ 步依序包括有前述之清洗6卜中和62、清洗63及‘ 化64步驟；其中，提供前述為去除血管支架表面肩 化層和其污染物所㈣之酸液’為達成其平衡目的4 於本發明係以鹼性液或弱鹼性液中和之而該中和 62步驟之中和液配方於本實施例係以冰碳^氮納口 :’而時間控制為2-3分鐘（min)’但並不以此㈣ 本：明’其亦可為任何可達中和目的之任何中和液 都屬本發明的保護範圍。 201215380 至於前述提高血管支架其耐腐兹性之純化64步 驟於本實施例其（鈍化液）配方及用量包括： 1、 重鉻酸鉀 15-20 g/L ; 2、 氬氧化鈉2-4 g/L ; 並控制其（酸鹼值）PH值至6.5-7.5，而時間控制在 5-10 分鐘（min)。 • 同樣的其間清洗61、63步驟，亦係去離子水沖洗數 次及使用吹風機烘乾。 前述金管支架清洗烘乾7，本發明執行該步驟之 目的，係為其使用醫療品前需先執行烘乾之步驟，再 執行清毒或滅菌之步驟，其目的在於完全徹底之清 潔，以避免血管支架受到外界之污染，同時也是在阻 癱止其他之化學污染或是使用滅菌劑以得到完全滅菌 與避免於微生物細胞的高接觸，進而影響到其後之消 毒或滅菌的效果。 〇 述之血管支架滅菌處理8，其過程係以高溫高 壓之消毒劑殺死牙孢或非牙孢的微生物，同時即殺死 可繁殖之細菌體、結核菌、黴菌及病毒，一般消毒時 ' 5 分1里，酒精殺細菌濃度範為 (V/V\ 一般使用為度70% (V/V)。而滅菌方式， 依其滅菌劑和滅菌方法不同’可分為蒸氣滅菌（高溫⑴ 201215380 高壓滅菌）、放射線滅菌、低溫電漿滅菌；其中，蒸 氣滅菌方式’其溫度高達約12rc，滅菌週期時間 短:約45-75分鐘’其對環境為無毒性，同時滅菌鍋 容量大’本發明係以此為主要前段^ ;而放射線滅 菌方式’係利用7 -ray或0 _ray放射線經由離子化 過程，原子撞擊其動能轉變成熱能及化學能，破壞微 生物之遺傳因子DNA，以達成殺死微生物的效果，其 鲁放射線穿透力高，但價格昂貴且須特殊儀器及防護措 施，本發明未來在量產時，可大量採用之同時，其效 果也較佳；至於，低溫電漿滅菌（過氧化電漿滅菌） 方式係於真空狀態下，利用電波能量刺激極度活化 的氣體，使氣體中之離子與分子互相碰撞產生自由 基，破壞微生物之新陳代謝功能，其可在低於5〇ΐ 下之環境進行滅菌處理，須使用特殊材質包裝心血管 ♦支架’對環境無毒性之殘存問題（氧氣及水），滅菌 週期短約5 5 - 7 5分鐘，為本發明第二階段之滅菌處理 方式’其優點為穩定性高等。 前述之血管支架半成品9,經由前述各步驟即 完成血·管支架。 相較於習知技術，本發明係在解決原材料取得 不易及國内對於毛細管料的拉抽和擠製及真空退火 處理一同步加工之經驗缺乏及沒有相關機械設備等[ 15 201215380 之缺失；目前攰欲n„ 加工機械，經由ΓΓ在^容易取得之原材料及 其内應力，以雷射加肌私方法，並且在於除去 溶潰及其他^物1 與酸洗液處理毛邊和 '、物，並且加上多次之電化學拋光處 面犯產生富鉻層，且適合人體之植入物。同 t為，其穩定品質、合理之價格，表面平滑'潔淨度 =抗飯性佳、低排斥性，並可提升使用之壽命，而 提出s亥專利之特別具有之新穎性、進步性及創新性特 異點。同時也可突破目前國際之血管支架之加工方 法，足見其增益之處。 .構:f本發明在突破先前之製造技術和 了構5又汁過程之困難，並且確實已達到所欲增進之功 效且也非所熟悉之已知技術和工藝者所易思及之加 工過程’再者’本發明申請前都未曾公開或發表，其 所具有之新穎性、進步性、創新性，顯已符合國内二 二之發明專利的申請要件，爰依法提出發明申請，懇 請貴局核准本件發明專利申請案，以勵發明，至感 德便。 〜 以上所述之實施例僅係為說明本發明之技術思 想及特點，其目的在使熟習此項技藝之人士能夠瞭解 本發明之内容並據此實施，當不能以此限定本發明之 專利範圍，即大凡依本發明所揭示之精神所作之均等 變化或修飾，仍應涵蓋在本發明之專利範圍内。 201215380 【圖式簡單說明】 第一圖：係為本發明之加工方法之流程方塊圖。 【主要元件符號說明】 1…原材料選擇準備 2…CAD設計模型 21··· CAE力學模擬和最適化設計 3…毛細管車削與拋光 3 1…原材料檢驗 4…數位雷射切割加工 5…超音波振動酸洗除屑 51···化學除油 5 2…清洗 53…去氧化皮層 5 4…清洗 6…血管支架電化學拋光 61…清洗 6 2…中和 63…清洗 17 201215380 64…純化 7·..血管支架清洗烘乾 8…血管支架滅菌處理 9…血管支架半成品 182, sodium hydroxide 10-20 g / L 201215380 3, sodium phosphate 15-25 g / ι; 4, emulsifier (〇 M 〇) 7-2 〇 ml / L., its control temperature is 25-30. . Between normal temperature; time is 1 (Μ5 minutes (mi η); h is described in the deoxidation layer 53 step in the formulation of this example: 1〇% dilute sulfuric acid' time is 10-15 minutes (min); In the process of cleaning 52, 54 in the process, it is washed several times with deionized water and dried by a hair dryer. The above-mentioned vascular stent is electrochemically polished 6, and the present invention removes the blood stent by the aforementioned ultrasonic vibration. Chip 5 and normal temperature chemical gap 'month wash 52, deoxidized skin layer 53 and cleaning 54, namely: ^ This step of the vascular stent electrochemical reduction of 6, which is performed at least several times '· its working mode is to vascular stent Connected to the anode, the raw metal is connected to the cathode, placed in the electrolyte, and the (4) device is started in the direct current control electrolyte to facilitate the electrolyte to control the temperature and the temperature; the electroplating will be performed by electrolysis. Vascular stent 々: removal of surface metal iron, increasing the amount of surface chrome metal and controlling the quality of the vascular stent surface will cause the erosion of the material or the hair and dirt of the material, the vascular stent is electroplated by electrolysis. 1 After use, the surface will have two effects, One is glossation, one of which is flattening the surface; and when electropolishing, a passivation layer is formed on the surface layer of the blood vessel 201215380, and the removal rate is also different due to the different metal molecules contained therein. During the process, the iron molecules contained in the surface will be removed first, so that the chromium knives left on the surface of the stainless steel will be extracted, that is, the iron molecules are precipitated and dissolved in the electrolyte, and the chromium is compared with the human body. Acceptable metal substance, the process is a "chromium-rich" reaction on the surface of the vascular stent, and the electrochemical polishing of the present invention can be performed once to three times, but the invention is not limited thereto, any number of times. It is within the scope of the present invention that the purpose of the electropolishing is to fill the surface layer of the vascular scaffold with chromium molecules or atoms, thereby causing a surface layer of chromium oxide to be formed on the surface, and the oxide layer is substantially effective for improving surface corrosion resistance. And during electropolishing, the surface layer of the blood-stained support will be removed from a layer containing dirt, oil, oxide, impurity layer, carbonized layer and internal stress layer. Substance, so the surface is very flat. Electropolishing will make the surface appeal to a high degree of clean layer and mirror level gloss. At the same time, it can remove the surface burrs of the fine structure of the two parts of the support rod and the connecting ring. The slag 'supplement can improve the surface flatness' and effectively reduce blood stasis, reduce the intimal hyperplasia after clinical implantation and reduce the subsequent inflammation, and improve the compatibility with vasculature and improve the therapeutic effect of both. The invention can be electropolated to remove the cracks easily generated by machining or materials, eliminate the problem of internal stress concentration, increase the service life and improve the fatigue performance of the material; and the vascular stent electrophoresis 201215380 polishing 6 steps of the present invention Its (electrolytic polishing liquid) formulation and usage include: phosphoric acid content (85%), use amount 600-700 ml / L; sulfuric acid content (98%), use amount is 200-300 ml / L; use of chromium trioxide The amount is 80 g / L; the additive is used in an amount of 10 g / L; the operating conditions are: control (electrolytic polishing liquid) temperature is 7 〇 _ 8 〇 C 'voltage control at 15-20 VC 18V), time control is 2 Minute . The additive which can change the polishing electrolyte viscosity and the polishing quality of the surface of the vascular stent and the impurity sensitivity is disclosed in the present embodiment as ethylene glycol, but the invention is not limited thereto, and it can also achieve the purpose. Any of the additives are within the scope of the present invention. After the sixth step of the electrochemical polishing of the vascular stent of the present invention, the step of cleaning, the cleaning, the cleaning, and the cleaning, and the step 64, wherein the step of removing the vascular stent surface and the surface thereof are provided. The acid solution of the pollutant (4) is used for the purpose of balance 4 in the present invention, neutralized by alkaline or weakly alkaline liquid, and neutralized in the 62 step and the liquid formulation is ice carbon in the present embodiment. Nitrogen sodium port: 'The time is controlled to 2-3 minutes (min)' but not (4) Ben: Ming's any neutralization liquid which can also be used for any neutralization purpose is within the scope of the present invention. 201215380 As for the above-mentioned purification step 64 for improving the resistance of the vascular stent, the formulation and dosage of the (passivation solution) in the present embodiment include: 1. Potassium dichromate 15-20 g/L; 2. Sodium arsenide 2-4 g/L; and control its (pH) pH to 6.5-7.5, and the time is controlled at 5-10 minutes (min). • During the same period of cleaning, steps 61 and 63 are also rinsed several times with deionized water and dried using a hair dryer. The above-mentioned gold tube bracket is cleaned and dried. The purpose of the present invention is to perform the steps of drying or sterilizing before using the medical product, and the purpose is to completely and thoroughly clean to avoid The vascular stent is contaminated by the outside world, and is also used to prevent other chemical contamination or use a sterilizing agent to achieve complete sterilization and avoid high contact with microbial cells, thereby affecting the subsequent sterilization or sterilization. The vascular stent sterilization treatment 8 described above is a process of killing the microporous or non-dental microorganisms with a high temperature and high pressure disinfectant, and killing the bacterium, tuberculosis, mold and virus which can be propagated, generally when disinfecting' In 5 minutes, the concentration of alcohol killing bacteria is (V/V\ is generally 70% (V/V). The sterilization method, depending on the sterilizing agent and sterilization method' can be divided into steam sterilization (high temperature (1) 201215380 Autoclave), radiation sterilization, low temperature plasma sterilization; among them, the steam sterilization method 'the temperature is up to about 12 rc, the sterilization cycle time is short: about 45-75 minutes', which is non-toxic to the environment, and the sterilization pot has a large capacity. This is the main front segment ^; and the radiation sterilization method uses 7-ray or 0 ray radiation through the ionization process, the atom impacts its kinetic energy into heat and chemical energy, destroys the microbial genetic factor DNA, and kills the microorganism. The effect is that the radio radiation penetration is high, but the price is expensive and special instruments and protective measures are required. The invention can be widely used in mass production in the future, and the effect thereof is also better; The low-temperature plasma sterilization (peroxidation plasma sterilization) method is based on the vacuum state, using the energy of the electric wave to stimulate the extremely activated gas, so that the ions and molecules in the gas collide with each other to generate free radicals, thereby destroying the metabolic function of the microorganism, which can Sterilization in an environment below 5 , requires the use of special materials to package the cardiovascular ♦ scaffold 'non-toxic residual problems (oxygen and water), the sterilization cycle is about 5 5 - 7 5 minutes, which is the invention The second stage of the sterilization treatment method has the advantages of high stability. The above-mentioned vascular stent semi-finished product 9 completes the blood tube stent through the above steps. Compared with the prior art, the present invention is difficult to solve the problem of raw materials. The lack of experience in the simultaneous processing of capillary material drawing and extrusion and vacuum annealing treatment and the absence of related mechanical equipment [15 201215380 is missing; currently the processing machinery, through the easy access to raw materials and Internal stress, in the laser plus muscle private method, and in the removal of the melt and other substances 1 and pickling treatment of the raw edges and ', And the addition of multiple electrochemical polishing surfaces to produce a chromium-rich layer, and suitable for human implants. With t, its stable quality, reasonable price, smooth surface 'cleanliness = good resistance to rice, low It is repulsive and can improve the life of use. It also proposes the unique, progressive and innovative singularity of the patent, and it can also break through the current international processing methods of vascular stents, which shows its gains. The invention is in the process of breaking through the previous manufacturing techniques and the difficulty of constructing the juice process, and has indeed achieved the desired effect and is not familiar to the known processes and processes that are easily understood by the craftsman' Furthermore, 'the invention has not been published or published before the application, and its novelty, progress, and innovation are in line with the application requirements of the domestic invention patents, and the invention application is filed according to law, and you are requested to approve it. This invention patent application, in order to invent invention, to the sense of virtue. The embodiments described above are merely illustrative of the technical spirit and characteristics of the present invention, and the objects of the present invention can be understood by those skilled in the art and can be implemented according to the present invention. Equivalent changes or modifications made by the spirit of the present invention should still be included in the scope of the present invention. 201215380 [Simple description of the drawings] The first figure is a flow block diagram of the processing method of the present invention. [Main component symbol description] 1... Raw material selection preparation 2... CAD design model 21··· CAE mechanical simulation and optimization design 3... Capillary turning and polishing 3 1... Raw material inspection 4... Digital laser cutting processing 5... Ultrasonic vibration Pickling dandruff 51···chemical degreasing 5 2...cleaning 53...deoxidation layer 5 4...cleaning 6...vascular stent electrochemical polishing 61...cleaning 6 2...neutralizing 63...cleaning 17 201215380 64...purification 7·. Vascular stent cleaning and drying 8...vascular stent sterilization 9...vascular stent semi-finished products 18