1280942 八、本案若有化學式時，請揭示最能顯示發明特徵的化學式： 九、發明說明： 【發明所屬之技術領域】 批量製作管狀支架的方法，特別係使用三種不同的微機電 製程技術來製作管狀支架，利用微影製程，配合微細電鐘製程 與化學機械研磨製程，可製作出成本低廉、線寬密度小、尺寸 形式多樣化、以及具有各式尺寸的盲孔以及通孔可供填充抗血 检藥物的批量管狀支架。1280942 VIII. If there is a chemical formula in this case, please disclose the chemical formula that best shows the characteristics of the invention: Nine, invention description: [Technical field of invention] The method of mass production of tubular stents, especially using three different microelectromechanical process technologies Tubular brackets, with lithography process, combined with micro-electric clock process and chemical mechanical polishing process, can produce low cost, small line width density, diversified size, and blind holes and through holes for various sizes Bulk tubular stent for blood test drugs.
【先前技術】 根據行政院衛生署所提供資料顯示’近年來，由於國人飲 食t償的西化力Π上缺乏適度的運動，使得心臟血管疾病已經 逐漸躍居國人十大死亡原_前3名。同時罹患心臟血管疾病 的j齡層亦有下降的趨勢。心臟血管疾病是現代文明病之一， 其:危險群包括：高轉、糖尿病、抽煙、高血脂及心血管疾 ’丙豕無史者其臨床表現有穩定型心絞痛、不穩定型心絞痛、 7 1280942 急性心肌梗塞及猝死。而急性心肌梗塞的死亡率更高達2⑽。 據估计’約有二分之—的冠狀續病患者接受血管成形術 、 及血#支賴療。血管絲是-種金屬不鏽鋼或其他特殊生醫 ‘材料所製造而成的一種血管内支撐器，可依其撐開方式分為= 囊擴張式與自擴張式。用以治療冠狀動脈心臟病的多為球囊擴 張式’將支架安裝於氣球導管之球囊上，沿血管輪送支架至病 變位置，將球囊絲，使球囊撐起支架後，之後再將球囊消氣 ⑩ 取出。支架則留於血管狹窄處以提供血管徑向支撐力，疏通血 管，使血流恢復。 在已知技術中’國外所製造的血管支架，大部分是使用雷 射切割成型的方式’亦有使用餘刻或是濺鍍沈積的方式。而在 國内，目前所使用的方式為用CNC線切割加工的方式 使用點銲的方式接合支架的兩端。 參考·月28日早期公告之美國專利公報，us • __92〇A1血管支架的製造方式，其製造的方式是使用薄 膜製程來製造血管支架。先在基材上沈積一層犧牲層咖_ .’而基材的種類可以是矽、金屬（不鏽鋼或鋁）、以及塑 、膠材料。而犧牲層的材料可以是Oxide layer(氧化層）或是 Nitride layer(氮化層）。接著在犧牲層上沈積—層光阻或是薄 膜’再利用微影製程將支架的幾何形狀定義出。接著再使用離 子束濺_方式沈積-層卜•㈣支社體。最後利用微機 電製私中的Li ft of f或是钱刻的方式將支架從基材上取下。此 8 1280942 種加工方式’雖財—次做出多樣化的支架形狀，然而其支架 的主體是使用麟的方式，而麟是—種沈魏率相當慢的一 • 種金屬沈積方式。對於-些厚度只要轩_鮮的支架而 f ’尚可加工完成。是使用在—些面積較大的血管上， 而需要厚度幾百_的支架而言，則需要耗費許多的濺鍍時間 、及成本f十於未來血官支架朝向各種尺寸血管大小的應用 上’尤其是較厚的血管上f要較厚的血管支架會有許多的限 Φ 希】#方面此早期公告的專利申請文件使用的犧牲層往往也 需要耗費較多的時間，才能使支架絲材分離。甚至在一些較 特殊的情況下，必需先使用急速加熱或是急速冷卻的方式使基 材先產生斷裂的情況’之後再將犧牲層去掉，最後才能順利的 將支架取下，步驟與過程相當的繁雜。 >考2004年5月20日早期公告的專利申請文件，仍 200401626G5A1血管支架的製造方式，其製造過程大約可分成 • 五大步驟’分勒支架的形狀設計與材料神備、使用雷射切 割或是侧的方式將絲㈣板上切割下來、將妓捲曲成圓 .形並使兩端點互相接觸、使用點銲(Spot Welding)的方式將材 料接合、最後使關械或是化學拋光的方式將錢的表面抛 光。使用雷射加工支架雖然加工的速度非常的快，但其生產成 本過於昂貴’因為一台雷射切割機其價格往往高達好幾千萬。 而且由於受雷射加工的限制，無法製造出網格密度較高的血管 支架’因此所生產的支架外型常常受到限制。另一方面，有些 9 1280942 小直角或是小圓角，雷射切割亦不易加工，的使得支架的 幾何形狀受義制。至於若使祕_方式，雖綠不會影響 、 綠的幾何職，但是使祕财式其所需的加讀間較長: 再加上侧之後表面錄不酬與不均自，容料致支架的生 物相容性降低。 4考中華民國專利公告編號576752，目前國内獲得專利之 唯-血管支架製造的方式。此種加卫方式主要紋用電腦緣製 • 絲的主體結構’再姻《工具機切削加工方式，將支架直 接從基材上蝴下來。接祕支料錢圓，最後再使用點鲜 的方式將核接合。此法受限於⑽工具機切麟線寬的限 制，此無法加工-些形狀複雜的支架結構。對於太小的圓弧 與彎角亦無法加工出。此外，常常受限於購買回來的基材表面 粗糖度太大以及厚度太厚，因此在加工之前必須制電解抛光 的方式來改善基_表面_度以及降絲獅厚度，經過如 • 此繁雜的先前準備工作，才能使其具有良好的生物相容性。另 外’線切割完成的支架，由於在切割_造成支架周遭的毛邊 •過A®此加工之後’也常常需要再使職光速度相當慢的電 、 纖光將毛邊去除。軸此法村细多層材料堆疊的方式， -次切出數根的材料。但是受到機械加工震動的影響，因此越 靠近材料下半部的支架，會造成尺寸偏差的現象 。因此此法實 際上一次只能加^根的支架’而加卫—根的時間往往也要2 個小％•的切削時間。因此這種加工方式除了耗費較長的加工時 1280942 間之外’支架尺寸也受限於最後點銲對位的問題，所以不易加 工尺寸較小的支架。另外也無法同時在支架上加工出可塗佈藥 物的微細孔洞，更無法整批大量的生產，因此難以因應未來廣 大支架市場的需求。 【發明内容】[Prior Art] According to the information provided by the Department of Health of the Executive Yuan, in recent years, due to the lack of moderate exercise in the Westernization of the Chinese people's drinking, the cardiovascular disease has gradually jumped to the top ten deaths of the Chinese people. At the same time, the j-age layer of cardiovascular disease also has a downward trend. Cardiovascular disease is one of the modern civilization diseases. Its risk groups include: high turnover, diabetes, smoking, hyperlipidemia and cardiovascular disease. The clinical manifestations of patients with stable angina pectoris, unstable angina, 7 1280942 Acute myocardial infarction and sudden death. The mortality rate of acute myocardial infarction is as high as 2 (10). It is estimated that 'about two-thirds of patients with coronary revascularization undergo angioplasty and blood therapy. The vascular silk is an intravascular support made of metal stainless steel or other special biomedical materials. It can be divided into capsule expansion and self-expansion according to its expansion method. Most of the balloons used to treat coronary heart disease are balloon-expandable. The stent is mounted on the balloon of the balloon catheter, and the stent is placed along the vessel to the lesion site. The balloon is placed so that the balloon is supported by the stent, and then Remove the balloon from the air 10 . The stent is left in the stenosis of the blood vessel to provide radial support for the blood vessel, to clear the blood vessels, and to restore blood flow. In the known art, most of the vascular stents manufactured abroad are in the form of laser cutting, and there is also a method of using residual or sputter deposition. In China, the current method is to use the method of CNC wire cutting to join the two ends of the bracket by spot welding. U.S. Patent Publication No. 28, the disclosure of which is incorporated herein by reference. First, a sacrificial layer is deposited on the substrate. The type of the substrate may be tantalum, metal (stainless steel or aluminum), and plastic or glue materials. The material of the sacrificial layer may be an Oxide layer or a Nitride layer. A layer of photoresist or a thin film is then deposited on the sacrificial layer. The geometry of the stent is then defined using a lithography process. Then use the ion beam splash _ way to deposit - layer Bu (4) branch body. Finally, the holder is removed from the substrate by means of a Li ft of f or a money engraving in a microcomputer. This 8 1280942 processing method has a diversified shape of the support, but the main body of the bracket is the way of using the lining, and the lining is a kind of metal deposition method with a relatively slow rate of sinking. For some thicknesses, as long as the Xuan_fresh bracket and f ’ can still be processed. It is used on some larger blood vessels, and the need for a stent with a thickness of several hundred _, it takes a lot of sputtering time, and the cost f is in the future application of blood donors to various sizes of blood vessels. In particular, thicker blood vessels have thicker vascular stents with many limits. The sacrificial layer used in this earlier published patent application often takes more time to separate the stent wire. . Even in some special cases, it is necessary to use the method of rapid heating or rapid cooling to cause the substrate to break first. Then the sacrificial layer is removed, and finally the stent can be removed smoothly. The steps are equivalent to the process. Complex. > The patent application file published on May 20, 2004 is still the manufacturing method of the 200401626G5A1 blood vessel stent. The manufacturing process can be divided into five major steps: the shape design and material preparation of the stent, the use of laser cutting or Is a side way to cut the wire (four) plate, curl the file into a round shape, and make the two ends point to each other, using Spot Welding to join the material, and finally to prevent or chemically polish the material. Polish the surface of the money. The use of laser processing brackets is very fast, but the cost of production is too expensive, because a laser cutting machine often costs tens of millions. Moreover, due to the limitation of laser processing, it is impossible to manufacture a blood vessel stent having a high mesh density. Therefore, the stent shape produced is often limited. On the other hand, some 9 1280942 small right angles or small rounded corners, laser cutting is also difficult to process, so that the geometry of the bracket is subject to justice. As for the secret _ way, although the green will not affect the green geometric position, but the secret financial type of the required reading is longer: plus the side after the surface recorded unpaid and uneven, the contents of the The biocompatibility of the stent is reduced. 4 The test of the Republic of China Patent No. 576752, the current patent-pending method for the manufacture of vascular stents. This type of reinforcement mainly uses the computer edge system. • The main structure of the wire is re-married. The tooling machine cuts the bracket directly from the substrate. Pick up the money, and finally use the fresh way to join the core. This method is limited by (10) the limitation of the width of the machine tool, which cannot be processed - some complex structure of the bracket. Arcs and corners that are too small cannot be machined. In addition, it is often limited by the fact that the surface of the purchased substrate is too coarse and too thick, so it is necessary to make an electrolytic polishing method to improve the base_surface_degree and the thickness of the lion's lion before processing. Previous preparations will make it biocompatible. In addition, the wire-cutting brackets are often removed from the burrs caused by the cutting of the burrs around the brackets and after the A® processing. The method of stacking thin multi-layer materials in this method is to cut a few pieces of material. However, due to the influence of mechanical vibration, the closer to the bracket of the lower half of the material, the size deviation will occur. Therefore, this method can only be used to add a root bracket to the last time, and the time of the root is often 2 small % of cutting time. Therefore, in addition to the long processing time of 1,280,942, the size of the bracket is limited by the problem of the final spot welding alignment, so it is difficult to process the smaller bracket. In addition, it is impossible to process micropores for coating drugs on the stent at the same time, and it is impossible to mass-produce a large number of batches, so it is difficult to cope with the demand of the future large stent market. [Summary of the Invention]
本發明有鑑於國内血管支架的需求有曰益增多的趨勢，而且 目鈾國内所使用之血管支架大多仰賴國外進口，每根支架的價格 大約8〜10萬，而具有微孔可塗佈抗血栓藥物的支架，價格更高達 15萬元。而已知目前現有技術中，國外之血管支架製造方式，主 要為雷射蝴細、侧成型、以及麟細的方式。在雷射成 型部分’ Φ於加的成本相當的昂貴，而且無法加卫出線寬密度 較小的支架’ SUb使得目前血管支架的價格相當的昂貴，而且支 架外型只*限於形綠為醉，線寬間練大的支架。此外，由 於使用雷射加J1的支架是糊基材—體成型，因歧管支架的管 狀、U冓厚度都是固定的，因此同—根血管支架無法製作出厚度不 同的支架結構，對於未來血f支架多方面的應用將是—大限制。 而使用勤m及賴的村，亦分财表面減差以及加工時間 過缺點，也無法製造出厚度不同的支架結構。反觀國内 目月丨』製造血管支架眺術，一次只能加工一根金管支架，因此無 1280942 法達到批量生產以降低血管支架的價格。另—方面，亦無法同時 加工出充填藥物的微孔以及無法製造出厚衫_支架結構。因 » 崎於絲血管支架醜财猶大的_。本發縣襲我們研 發多年的厚光阻微影、微細賴與化學機械研磨的技術，將其應 用於高價_度高的管狀支架。其特點除了批量生產而能超鋪 外，而且支架的管徑可能推向世界最小，同時又具有能輕易埋入 抗血栓等藥物的細孔。 • 本發_目的之―，乃是顧郷製程，配合鮮的設計以及 厚光阻的使用’可設計出線寬密度小，幾何形狀多樣化以及具有各 式尺寸盲孔無孔可供填絲物的整崎狀絲。再顧金屬沈積 速度最快的微細電鑛技術，可快速的將整批管狀支架的結構製造 出。最後再细化學機械研磨的製程，其製程不但可將整批管狀支 架的尺寸達到均-化，而且還可提昇管狀支架的表面粗縫度，以提 高管狀支架的生物相容性。最後再使用銲接的方式接合管狀支架的 • 兩端。 本毛月的目的之一’乃疋利用LIGA或類LIGA製程，設計與翻 製出官狀支架幾何形狀的電極，配合微放電加工的製程，可快速製 造出批1的官狀支架。此法，相當適合使胁各式金屬的基材上， 尤其疋-些現有生物相容性良好的基材如，不鐵鋼、欽合金、鎮合 至等等。另外，因為運用微放電加工的技術，具有管狀支架幾何形 狀的電極可重欠侧，平均成本擁為低廉。 本發明的目的之三，乃利用多層微影對準的技術，以及微電鍍 1280942 多層堆疊的技術，並且配合化學機械研磨製程，可快速製造出尺寸 精確，不需點銲接合一體成型的管狀支架。此法，由於不需考慮銲 接接合的問題，相當適合製作尺寸微小的管狀支架。 本發明的目的之四，乃利用多層光阻塗佈以及多層微細電鍍， 可使相同的一根管狀支架具有不同的厚度結構，因此可達到每根管 狀支架填充藥物的微孔具有不同的深度。如此，不但有利於管狀支 架外型結構設計的彈性化，更可使支架填充藥物有更多元化與彈性 的應用，對於未來管狀支架的應用有相當大的助益。 【實施方式】 本發明提出三個實施例，其所使用的製程與設備先行說明 如下，參考圖一、圖二、與圖三： 微影製程是使用正光阻、負光阻、P〇lyimide(聚亞醯胺）等旋 塗於基材的表面，並利用光罩加以曝光後顯影出定義的支架結構。 微細電鍍是利用具有電源供應器、鍍液槽、加熱器、溫控回饋 裝置等電鐘設備組合而成，其可用來製造管狀支架的主體結構。 化學機械研磨是利用具有研磨墊、研磨液、晶圓載具、研磨液 攪拌幫浦等化學機械研磨設備組合而成，其可用來平坦化基材上 所有的管狀支架的結構，以提昇支架的表面粗糙度，使其具有符 合人體置放的生物相容性。 13 1280942 管狀支架從基材上取下，是利用超音波震洗設備配合光阻或是 Polyimide的去光阻劑，或是利用反電鍍的方式將管狀支架從基 ' 材上取下，而管狀支架彎曲滾圓則是利用具有圓形凹槽、圓形桿 件、以及具有滾輪的滾軋夾具等製作而成。 微細放電的設備是由RC控制迴路、NC精密定位平台、光學尺、 放電電極專微放電加工設備組合而成，其可直接用於生物相容性 質良好的金屬或合金基材上，可製作出不需再沈積一層管狀支架。 _ 銲接製程’利用具有電器控制系統、金屬電極、管狀支架夾持 裝置等銲接設備組合而成，其可用來接合管狀支架的兩端，使管 狀支架的形狀固定成為適合球囊充氣的幾何形狀。 微細電鍍製程，其中電鍍管狀支架的金屬配合電鍍晶種層可 為鎳鉛合金、鎳鐵合金等相關的金屬或是合金。 機械化學研磨製程，其中研磨墊的材質配合電鍍後的金屬或 疋合金的成分可分為硬墊與軟墊，硬墊的組成以不鏽鋼金屬盤為 • 主，而軟墊的材料則以不織布或Polyurethane(聚亞胺脂）等為主 的研磨墊材料；而研磨液的成分配合配合電鍍後的金屬或是合金 的成分可為Al2〇3、Si〇2等研磨液。 • 齡金的浸難程’是制市面上(轉概)鑛好的鈦合 金浸鍍液，此種浸鍍液適合各式基材的浸鍍，例如一般的碳鋼、 不鏽鋼、銘、錄以及其他的金屬與合金。此種鈦合金鑛磨具有良 好的耐磨性、防鏽性、更重要的是具備良好的生物相容性，相當 適合生醫材料與元件表面的減。此魏製雜作步驟相當的簡 14 1280942 單’將浸鍍液用純水稀釋成適合浸鍍的比例，並加熱至9〇乞的溫 度’即可進行浸鍍的製程。大約2〜5分鐘，即可在浸鑛材料的内 外，沈積上一層精緻細密的鈦薄膜。而鈦薄膜的厚度與浸鍍液稀 釋的比例，被鍍物的材質厚度有很大的相關性。 [實施例一]:參考圖一 步驟一 ··如圖四（a)所示，在基材1上濺鍍或蒸鍍兩層分別為（Cr)2及 銅(Cu)3 的晶種層（UBM Layers)。 步驟二：如圖四（b)所示，旋塗厚光阻4。 步驟三：如圖四（c)所示，利用軟烤、曝光顯影以及硬烤，定義出支架 欲電鍍的圖案5。 步驟四：如圖四（d)所示，微細電鑛支架6。 步驟五：如圖四（e)所示，利用化學機械研磨將電鍍後支架表面平坦化 成平面支架7。 步驟六：如圖四（f)所示，去除厚光阻4。 步驟七：如圖四（g)所示，從基材上取下平面支架7。 步驟八··如圖四(h)所示，接著將平面支架彎曲捲成管狀8。 步驟九：如圖四（i)所示，並使用銲接的技術接合兩端完成管狀支架9。 步驟十：如圖四（j)所示，將管狀支架9内外浸鍍生物相容的材料如鈦 (Ti)10，完成具生物相容的管狀支架。 步驟三的光罩圖案，可設置定義貫穿孔，有利於支架填充藥物。 再者，步驟二至步驟五可重複多次，而步驟三的光罩圖案可以每次不 15 1280942 同，如圖五所示，可使支架表面定義出有不賊淺的縣Μ，如圖六 所示’或盲孔22，如圖七所示，或貫穿孔烈，如圖八所示，如此不作 可使相同的-根管狀支架具有不同的厚度結構，有利於管狀支竿外型 .結構設計的彈性化，更可使支架填充藥物有更多元化與彈性的應用。 [實施例二]:參考圖二 步驟一：如圖九(a)所示，在基材31旋塗厚光阻32。 籲步驟二：如圖九⑹所示’利用軟烤、曝光顯影以及硬烤，定義出支架 電極欲電鍍的圖案33。 步驟三：如圖九(c)所示，電鍍支架電極34。 步驟四：如圖九⑷所示’利用化學機械研磨將支料極電鍍的表面平 坦化35，並去除厚光阻31。 步驟五：如圖九(e)所示，利用平坦化後的支架電極35置於不鏽鋼基 材36上方，進行微放電加工獲得平面支架37。 馨步驟六：如圖九（f)所示，將平面支架37從微放電機台取下。 步驟七：如圖九(g)所示，將平面支架37彎曲捲成管狀支架38。 步驟八：如圖九(h)所示，使用銲接的技術接合兩端成為管狀支架39。 ^ 步驟二的光罩圖案，可設置定義貫穿孔，有利於支架填充物。 再者，步驟一至步驟四可重複多次，而步驟二的光罩圖案可以每次不 同’使支架電極表面有不同深淺的突出長柱41或短柱42，如圖十所 示，如此進行放電後不但可使相同的一根管狀支架具有不同的厚度結 16 l28〇942 構:有利歸狀支架外赌構設計的雜化，更可蚊輯充藥物有 夕元化與彈性的應用。注意此處被微放電的材料，亦即支架，、可以 有多種選擇，只要能被放電的金屬皆可，特別是與生物相容的材料， 如不銹鋼、鈦、鉬、鉻、鈕、鎂、鎳及其合金等。 [實施例三]••參考圖三 步驟一：如圖十一（a)所示，在基材51上濺鍍或蒸鑛兩層鉻⑹52及 _ 銅（〇1)53 的晶種層（UBM Layers)。 步驟二：如圖Η^一（W所示，旋塗第一層厚光阻54。 步驟三：如圖十-（c)所示，利用軟烤、曝光顯影以及硬烤，定義出下 支架欲電鍍的部分55。 步驟四：如圖H W)所示，電鍍下支架56。 步驟五：如圖十-(e)所示，利用化學機械研磨將下支架電鍍的表面平 坦化57。 φ步驟六：如圖十一（f)所示，旋塗第二層厚光阻58。 步驟七：如圖十一（g)所示，利用軟烤、曝光顯影以及硬烤，定義出上 下支架中間連結欲電鑛的部分59。 步驟八：如圖十一（h)所示，濺鍍第二層銅(Cu)晶種層6〇。 步驟九：如圖十一（i)所示，電鍍支架中間上下連結的結構61，使用 化學機械研磨將光阻上多餘的金屬層磨除。 步驟十：如圖十一（j)所示，旋塗第三層厚光阻62。 步驟十一：如圖十一（k)所示，利用軟烤、曝光顯影以及硬烤，定義出 17 Ϊ280942 上支架欲電鍍的部分63。 夕驟十二··如圖十一（1)所示，電鍍上支架64。 V驟十三：如圖十一⑻所示’利用化學機械研磨將上支架電鑛的表面 ^ 平坦化65，並將支架旁邊多餘的光阻去除。 ^驟十四··如圖十-(Π)所*，將方管支架66從基材上取下。 ,-十五.如圖_J一（0)(p)所示，將方管支架66彎曲滾圓成圓管支架 67，或管狀支架。 力十六：如圖十一（q)所示，將圓管支架67内外浸鍍生物相容的材 料如鈦(Ti)l〇，完成具生物相容的管狀支架。 P步驟三與十-的光罩圖案，可設置定義貫穿孔，有利於支架填充 ^物再者’步驟二至步驟五，以及步驟十至步驟十三，皆可重複多 …而步驟二的光糊案可以每次不同，如圖五所示，可使支架表面 =出有不同深淺的溝渠2卜如圖六所示，或盲孔22，如圖七所示， 或貝牙孔23 ’如圖八所示，如此不但可使相同的—根管狀支架具有不 同的厚度結構，有利於管狀支架外型結構設計的彈性化，更可使支架 填充藥物有更多元化與彈性的應用。 部分實驗結果：圖十二為使財補—，批量f狀支架微影後的 實照圖。圖十三為實施例―，f狀支架微影後從基材上取下的平面支 架的實麵。圖切實是施例…光阻去除後具有填充藥物通孔⑷〇〇 Am)管狀支架實照圖。圖十五是實施例一，銲接接合後管狀支架實照 18 1280942 1¾ Λ W ’鮮接接合後管狀支架長X寬X厚的尺寸為（5mmx2. 5mmx0. lmm)。圖 十^、乃實施例一，銲接接合後管狀支架實照圖2，銲接接合後管狀支 架長X寬X厚的尺寸為(5mmx2· 5mmx0· 1mm)。 【圖式簡單說明】 圖一·本發明第一種管狀支架製作流程圖。 圖二··本發明第二種管狀支架製作流程圖。 圖三：本發明第三種管狀支架製作流程圖。 圖四：實施例一管狀支架詳細製作流程。 圖五：管狀支架光罩設計圖。 圖六··不同深淺溝渠管狀支架製作示意圖。 圖七：盲孔管狀支架製作示意圖。 圖八：貫穿孔管狀支架製作示意圖。 圖九··實施例二管狀支架詳細製作流程。 圖十：不同深淺管狀支架電極製作示意圖。 圖十一：實施例三管狀支架詳細製作流程。 圖十二：實施例一批量管狀支架微影後實照圖。 圖十二·實施例一管狀支架微影後從基材上取下的平面支架實日召 圖。 圖十四：實施例一光阻去除後具有填充藥物通孔管狀支架實照圖。 19 1280942 圖十五：實施例一銲接接合後管狀支架實照圖卜 圖十六：實施例一銲接接合後管狀支架實照圖2。 【主要元件符號說明】 1. 基材 2. 鉻(Cr)沉積層 3. 銅（Cu)沉積層 4. 塗佈的厚光阻 5. (曝光顯影）支架欲電鍍的圖案 6. 微細電鍍後的支架 7. 平坦化後的支架 _ 8.平面支架彎曲捲成的管狀支架 9. 銲接接合後的管狀支架 10. 鈦(Ti)沉積層 ' 21.具有不同深淺溝渠的管狀支架 • 22.具有盲孔的管狀支架 23.具有通孔的管狀支架 31. 電極基材 32. 塗佈的厚光阻 20 1280942 33. (曝光顯影）電極欲電鍍的圖案 34. 微細電鍍後的管狀支架電極 35. 平坦化後的管狀支架電極 36. 不鐘鋼基材 37. 微放電加工後獲得的平面支架 38. 平面支架彎曲捲成的管狀支架 39. 銲接接合後的管狀支架 41. 具有長柱的管狀支架電極 42. 具有短柱的管狀支架電極 51. 基材 52. 鉻(Cr)沉積層 53. 銅（Cu)沉積層 54. 塗佈的第一層厚光阻 55. (曝光顯影）下支架欲電鍍的圖案 56. 微細電鍍後的下支架 57. 平坦化後的下支架 58. 塗佈的第二層厚光阻 59. (曝光顯影）中間支架欲電鍍的圖案 60. 銅（Cu)沉積層 61. 微細電鍍後的中間支架 62. 塗佈的第三層厚光阻 63. (曝光顯影）上支架欲電鍍的圖案 21The invention has the trend of increasing the demand for the domestic vascular stent, and most of the vascular stents used in the uranium domestic are relying on foreign imports, and the price of each stent is about 8 to 100,000, and the microporous can be coated. The stent for anti-thrombotic drugs is up to 150,000 yuan. However, in the prior art, the manufacturing method of the blood vessel stent in foreign countries is mainly a laser hair thin, side molding, and a thin manner. In the laser forming part, the cost of adding Φ is quite expensive, and it is impossible to add a bracket with a small line width density. SUb makes the current price of the vascular stent quite expensive, and the stent shape is limited to the shape of green. , the large bracket between the line width. In addition, since the stent using the laser plus J1 is a paste substrate-body molding, since the tubular and U-thickness of the manifold stent are fixed, the same-vessel stent cannot produce a stent structure having a different thickness for the future. The multi-faceted application of blood f stents will be a large limitation. In the villages where the use of the M and the Lai are also used, the surface reduction and the processing time are too short, and it is impossible to manufacture a stent structure with different thicknesses. On the other hand, the domestic eyesight 制造 制造 血管 制造 制造 制造 制造 制造 制造 制造 制造 制造 制造 制造 制造 制造 制造 制造 制造 制造 制造 制造 制造 制造 制造 制造 制造 制造 制造 制造 制造 制造 制造On the other hand, it is impossible to process the micropores filled with drugs at the same time and to make a thick shirt_support structure. Because of the singularity of the vascular stent. This county has attacked the technology of thick photo-resistance lithography, micro-reliance and chemical mechanical grinding for many years, and applied it to high-priced _ high tubular stents. Its characteristics are super-sanding in addition to mass production, and the diameter of the stent may be pushed to the smallest in the world, and at the same time, it has pores that can be easily embedded in anti-thrombosis drugs. • This is the purpose of the 郷 , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , The entire shape of the object. Relying on the fastest micro-electrode mining technology, the structure of the entire batch of tubular supports can be quickly manufactured. Finally, the process of fine chemical mechanical grinding can not only achieve uniform size of the entire batch of tubular supports, but also improve the surface roughness of the tubular support to improve the biocompatibility of the tubular support. Finally, the two ends of the tubular bracket are joined by welding. One of the purposes of this month is to use the LIGA or LIGA-like process to design and reproduce the electrode of the official frame geometry, and with the process of micro-discharge machining, the official stent of the batch 1 can be quickly manufactured. This method is quite suitable for the substrate of various metals, especially those which have good biocompatibility, such as non-ferrous steel, alloy, sinter and so on. In addition, because of the micro-discharge machining technique, the electrode having the geometry of the tubular support can be retracted to the side, and the average cost is low. The third object of the present invention is to utilize the technique of multi-layer lithography alignment and the technology of micro-plating 1280942 multi-layer stacking, and in combination with the chemical mechanical polishing process, a tubular bracket with precise dimensions and no need for spot welding can be quickly manufactured. . This method is quite suitable for making small-sized tubular supports because it does not need to consider the problem of solder joints. The fourth object of the present invention is to use a multi-layer photoresist coating and a multi-layer micro-plating to make the same tubular stent have different thickness structures, so that the micropores filled with drugs can be different for each tubular stent. depth. In this way, it not only facilitates the flexibility of the tubular frame design, but also enables the stent to be filled with more diversified and elastic applications, which is of great benefit to the future application of the tubular stent. [Embodiment] The present invention proposes three embodiments, and the processes and devices used are first described as follows. Referring to FIG. 1, FIG. 2, and FIG. 3: The lithography process uses positive photoresist, negative photoresist, and P〇lyimide ( Polyimine) is spin-coated on the surface of the substrate and exposed to light to develop a defined stent structure. Micro-plating is a combination of electric clock devices with a power supply, plating bath, heater, temperature-controlled feedback device, etc., which can be used to manufacture the main structure of the tubular support. Chemical mechanical polishing is a combination of chemical mechanical polishing equipment such as polishing pad, polishing liquid, wafer carrier, and slurry agitation pump. It can be used to planarize the structure of all tubular supports on the substrate to enhance the surface of the support. Roughness makes it biocompatible with body placement. 13 1280942 The tubular support is removed from the substrate by using an ultrasonic shock-washing device with photoresist or Polyimide's photoresist, or by using a counter-plating method to remove the tubular support from the base material. The bracket bending and rounding is made by using a circular groove, a circular rod, and a rolling jig having a roller. The micro-discharge device is a combination of RC control circuit, NC precision positioning platform, optical ruler and discharge electrode special micro-discharge processing equipment. It can be directly used on metal or alloy substrates with good biocompatibility. There is no need to deposit a layer of tubular support. The _welding process is a combination of welding equipment having an electrical control system, a metal electrode, a tubular bracket holding device, etc., which can be used to engage the ends of the tubular stent to fix the shape of the tubular stent into a geometry suitable for inflation of the balloon. The micro-plating process, wherein the metal-plated plating seed layer of the plated tubular support may be a metal or alloy related to nickel-lead alloy, nickel-iron alloy or the like. Mechanochemical polishing process, in which the material of the polishing pad is matched with the composition of the plated metal or tantalum alloy, which can be divided into hard mat and cushion, the hard cushion is composed of stainless steel metal disc, and the cushioned material is non-woven or A polishing pad material such as Polyurethane (polyimide) or the like, and a component of the polishing liquid and a metal or alloy component after plating may be a polishing liquid such as Al2〇3 or Si〇2. • The ageing process of gold is a good titanium alloy immersion bath on the market (transformation). This immersion bath is suitable for immersion plating of various substrates, such as general carbon steel, stainless steel, Ming, and recorded. And other metals and alloys. This titanium alloy ore has good wear resistance, rust resistance, and more importantly, good biocompatibility, which is quite suitable for the reduction of biomedical materials and component surfaces. This Wei-made miscellaneous step is quite simple. 1 1280942 Single 'Drip the immersion bath with pure water to a ratio suitable for immersion plating, and heat to a temperature of 9 ’ to perform the immersion plating process. About 2 to 5 minutes, a fine and fine titanium film can be deposited inside and outside the leaching material. The ratio of the thickness of the titanium film to the dilution of the immersion bath has a large correlation with the material thickness of the object to be plated. [Example 1]: Referring to Figure 1 Step 1 · As shown in Figure 4 (a), two layers of (Cr) 2 and copper (Cu) 3 seed layers are sputtered or vapor-deposited on the substrate 1 (UBM Layers). Step 2: As shown in Figure 4 (b), spin-coat the thick photoresist 4. Step 3: As shown in Fig. 4(c), the pattern 5 to be plated by the holder is defined by soft baking, exposure development, and hard baking. Step 4: As shown in Figure 4 (d), the fine electric ore support 6. Step 5: As shown in Fig. 4(e), the surface of the plated stent is flattened into a planar support 7 by chemical mechanical polishing. Step 6: Remove the thick photoresist 4 as shown in Figure 4 (f). Step 7: As shown in Figure 4 (g), the planar support 7 is removed from the substrate. Step 8· As shown in FIG. 4(h), the planar support is then bent into a tubular shape 8. Step 9: As shown in Fig. 4(i), the tubular support 9 is completed by joining the ends using a welding technique. Step 10: As shown in Fig. 4(j), the inner and outer portions of the tubular support 9 are immersed with a biocompatible material such as titanium (Ti) 10 to complete a biocompatible tubular support. Step 3 of the reticle pattern can be set to define the through hole, which is beneficial to the stent to fill the drug. Furthermore, step two to step five can be repeated multiple times, and the mask pattern of step three can be the same as 15 1280942 at a time, as shown in FIG. 5, the surface of the bracket can be defined as a county with no thief, as shown in the figure. The six or 'blind hole 22', as shown in Figure 7, or through the hole, as shown in Figure 8, so that the same - root tubular stent has a different thickness structure, which is conducive to the shape of the tubular support The flexibility of the structural design enables the stent to be filled with more diversified and elastic applications. [Embodiment 2]: Refer to FIG. 2 Step 1: As shown in FIG. 9(a), a thick photoresist 32 is spin-coated on the substrate 31. Step 2: As shown in Figure 9 (6), the pattern 33 to be plated by the holder electrode is defined by soft baking, exposure development, and hard baking. Step 3: As shown in FIG. 9(c), the holder electrode 34 is plated. Step 4: As shown in Fig. 9 (4), the surface of the electroplated electrode is flattened by chemical mechanical polishing 35, and the thick photoresist 31 is removed. Step 5: As shown in Fig. 9(e), the flattened stent electrode 35 is placed over the stainless steel substrate 36, and micro-discharge machining is performed to obtain the planar support 37. Xin Step 6: As shown in Figure 9 (f), the planar support 37 is removed from the micro-discharge machine. Step 7: As shown in FIG. 9(g), the flat bracket 37 is bent and rolled into a tubular bracket 38. Step 8: As shown in FIG. 9(h), the ends are joined to form a tubular support 39 using a welding technique. ^ Step 2 of the reticle pattern can be set to define the through hole to facilitate the bracket filler. Furthermore, the steps 1 to 4 may be repeated a plurality of times, and the mask pattern of the second step may be different each time, so that the surface of the holder electrode has different lengths of the protruding long column 41 or the short column 42, as shown in FIG. After that, not only can the same tubular stent have different thicknesses. 16 l28〇942 structure: it is advantageous for the hybridization of the gambling design of the categorized stent, and the application of the mosquito-filled drug has the eclipse and elasticity. Note that the material that is microdischarged here, that is, the stent, can be selected in a variety of ways, as long as it can be discharged, especially biocompatible materials such as stainless steel, titanium, molybdenum, chrome, button, magnesium, Nickel and its alloys. [Embodiment 3]•• Refer to FIG. 3 Step 1: As shown in FIG. 11(a), two kinds of chromium (6) 52 and _ copper (〇1) 53 seed layers are sputtered or evaporated on the substrate 51 ( UBM Layers). Step 2: As shown in Fig. 1, the first layer of thick photoresist 54 is spin-coated. Step 3: As shown in Figure 10-(c), the lower bracket is defined by soft baking, exposure development and hard baking. Portion 55 to be plated. Step 4: As shown in Figure HW), the lower bracket 56 is plated. Step 5: As shown in Fig. 10-(e), the surface of the lower stent plating is flattened by chemical mechanical polishing 57. φ Step 6: As shown in Figure 11 (f), spin the second layer of thick photoresist 58. Step 7: As shown in Fig. 11(g), the soft-baked, exposed-developed, and hard-baked portions are used to define a portion 59 in which the upper and lower brackets are connected to the desired electric ore. Step 8: As shown in FIG. 11(h), a second layer of copper (Cu) seed layer 6 is sputtered. Step 9: As shown in Fig. 11(i), the structure 61 of the upper and lower sides of the plating holder is mechanically ground to remove the excess metal layer on the photoresist. Step 10: As shown in FIG. 11(j), the third layer of thick photoresist 62 is spin-coated. Step 11: As shown in Figure XI (k), using soft bake, exposure development, and hard bake, define the portion 63 to be plated on the 17 Ϊ 280942 upper bracket. On the other hand, as shown in Fig. 11 (1), the upper bracket 64 is plated. V. XIII: As shown in Fig. 11 (8), the surface of the upper scaffold is planarized by chemical mechanical polishing to 65, and the excess photoresist on the side of the stent is removed. ^Step XIV·· As shown in Fig. 10-(Π)*, the square tube holder 66 is removed from the substrate. , -15. As shown in Fig. _J_(0)(p), the square tube bracket 66 is bent and rounded into a round tube bracket 67, or a tubular bracket. Force 16: As shown in Figure XI (q), the inner tube of the round tube holder 67 is immersed with a biocompatible material such as titanium (Ti) l to complete a biocompatible tubular holder. P steps three and ten - the reticle pattern can be set to define the through hole, which is beneficial to the stent filling method, and then step two to step five, and steps ten to step thirteen, all of which can be repeated... and the light of step two The paste case can be different each time, as shown in Figure 5, the surface of the support can be made with different depths of the trench 2 as shown in Figure 6, or the blind hole 22, as shown in Figure 7, or the shell hole 23 ' As shown in Fig. 8, not only can the same-root tubular stent have different thickness structures, which is beneficial to the elastic design of the tubular stent outer structure design, and the stent-filling drug has more diversified and elastic applications. Part of the experimental results: Figure 12 is a real photo of the accompaniment of the batch-f-shaped stent. Fig. 13 is a view showing the solid surface of the planar support removed from the substrate after the f-shaped stent is lithographically in the embodiment. The figure is actually a case... after the photoresist is removed, there is a filled drug through hole (4) 〇〇 Am). Figure 15 is a first embodiment, the tubular stent after welding and welding 18 1280942 13⁄4 Λ W ’ fresh joint after the length of the tubular stent X width X thickness (5mm x 2. 5mmx0. lmm). Fig. 10 is the first embodiment. After the welding, the tubular support is shown in Fig. 2. After the welding, the length of the tubular support is X (width x width) and the thickness is (5 mm x 2 · 5 mm x 0 · 1 mm). BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a flow chart showing the first tubular stent of the present invention. Figure 2 is a flow chart of the second tubular stent of the present invention. Figure 3: Flow chart of the third tubular stent of the present invention. Figure 4: The detailed production process of the tubular stent of the first embodiment. Figure 5: Design of the tubular bracket reticle. Figure VI. Schematic diagram of the fabrication of tubular supports for different deep and shallow ditches. Figure 7: Schematic diagram of the blind hole tubular stent. Figure 8: Schematic diagram of the production of a through-hole tubular stent. Figure 9··Example 2 The detailed production process of the tubular support. Figure 10: Schematic diagram of the fabrication of different deep and shallow tubular stent electrodes. Figure 11: The detailed production process of the tubular stent of the third embodiment. Figure 12: Example 1 of a batch tubular stent after lithography. Figure 12. Embodiment 1 shows a plan view of a planar support removed from a substrate after lithography of the tubular support. Fig. 14 is a perspective view of a tubular stent having a filled drug through hole after the photoresist removal in the first embodiment. 19 1280942 FIG. 15 : Embodiment 1 shows the actual situation of the tubular support after the welded joint. FIG. 16 : Embodiment 1 shows the tubular support after the welded joint. [Main component symbol description] 1. Substrate 2. Chromium (Cr) deposited layer 3. Copper (Cu) deposited layer 4. Coated thick photoresist 5. (Exposure development) The pattern to be plated by the support 6. After fine plating Bracket 7. Flattened bracket _ 8. Flat bracket curved tubular bracket 9. Post-welded tubular bracket 10. Titanium (Ti) deposit layer' 21. Tubular bracket with different depth and shallow trenches Tubular support for blind holes 23. Tubular support with through holes 31. Electrode substrate 32. Coated thick photoresist 20 1280942 33. (Exposure development) Electrode plating pattern 34. Micro-plated tubular support electrode 35. Flattened tubular stent electrode 36. Stainless steel substrate 37. Flat stent obtained after micro-discharge machining 38. Flat stent rolled tubular stent 39. Tubular stent after welding joint 41. Tubular stent electrode 42 with long column Tubular stent electrode with short post 51. Substrate 52. Chromium (Cr) deposited layer 53. Copper (Cu) deposited layer 54. Coated first layer of thick photoresist 55. (Exposure development) Lower bracket to be plated Pattern 56. Micro-plated lower bracket 57. Flattened lower branch 58. Coated second layer of photoresist 59. (exposure development) intermediate bracket to be plated pattern 60. Copper (Cu) deposited layer 61. Micro-plated intermediate support 62. Coated third layer of thick photoresist 63. (exposure development) pattern of the upper bracket to be plated 21