201136574 四、指定代表圖： (一) 本案指定代表圖為：第（2 )圖。 (二) 本代表圖之元件符號簡單說明： 1 球囊 2 支架 3 包絡支架置放件 4 標記 9 主動脈 10 腎動脈 11 導管 12 動脈瘤病灶 13 腸骨動脈 五、本案若有化學式時，請揭示最能顯示發明特徵的化學式： 、發明說明： 【發明所屬之技術領域】 本發明係關於一種球囊擴張式支架組件，以織物或聚 合物包絡，且於擴張後維持其狀態，特別是用於動脈瘤之 治療上。 201136574 【先前技術】 動脈瘤是一種血管疾病其發生於腹部動脈上直徑大於 2公分。一般來說，在這方面，會形成血管壁擴大和撕裂跡 象。當這種疾病的進展’會見到血管剝離和破裂事件以及 血管直徑的過度増加。血管直徑達5公分及破裂事件酉導 致大出血和終於死亡的風險。 傳統的治療方法是動脈瘤手術的介入。與此病有關部 份是剖開，試圖修復它。修復操作的形式不是採縫合，就 疋植入管狀形式的生物相容性構件。雖然這種方法是世界 上最多被採用的作業，治療期間之時間長，及老年患者遭 受手術治療的相關風險，增加了使用支架的應用。 關於支架植入術，許多不同的應用程序已經發展到以 支架放置在動脈瘤凸起的地區。如美國專利Ep7l2614中所 披路的，也是這種方法的一種，其使用一個可擴展設計的 支架植入動脈瘤凸起的地區，還加上支架内的球囊。雖然 根據該披露，基本上是一個理想的體現之設計，沒有多少 提到的是支架組件外㈣置。該專利除了缺乏披露有關支 架的内外壁’匕有—些缺點，在於該支架裝到血管病灶處 以掛鉤固定。其最重要的缺點是，助_度和損害血管 結構的風險。此外’該專利中對支架的彈性結構與^定沒 有任何說明。它只提到支架裝壯管纽處以掛釣固定。 另:種對動脈瘤支架植入術的方法是使用一種自膨式 支架這貫施;^涉及許乡專利技術。這種支架實施方式 之基本特徵是以緊縮狀態的支架置人血管病灶處，而釋放 =彈性支紐其在該處發生自我舰事件。㈣這樣的结 構可能被視為理論上很容易，在實用上引進緊縮的支架管 201136574 ，都需要一個複雜的裝置，並導 它既會導致執行困難，也會增加 内，然後讓它擴張 致應用中的©難。因此， 成本。 【發明内容】 動脈瘤的’是設計與實現—個支架制是使用在 相容性織物1 可在控制T擴張的球囊的方式，並以生物 本發明的t龍(？標名)’或任何其他材料包絡其外。 困難 女Α1”、、自我擴張或球囊擴張的支架之配置 張=的程支==一製^ 目‘’疋盡量減少複雜的設計和應用相關的 個很 架組件植人血^它能保持這—擴張的狀態。隨著球囊-支 在金管之内彳^此峰之外麵親，錢它完全靠 ^ 以便在該處提供適當的固定。此功能得 鋼 材為=Γΐ於下述事實，該支架中使用的材料是以 定程产ίΐΐ 有_的功_材料，—旦膨脹到一 ==擴張狀態。此外’使用彈性的織物或類似 羽去生材料’包絡支架和支架管—起移動，消除了 白知技術中所遭遇到的缺陷。 if、，的谷易度而s最佳的是支架材料於擴張或膨脹 =的穩4，及有彈性輯物或類似之生物相容性材料 Ά絡支架且在支雜球囊膨脹時隨著支架擴張。另一個 優點是不需要複雜的掛鉤或夾鉗以固定支架於血管中 【實施方式】 本發明之支架置放組件包括：一擴張式支架2; 一包絡 支架置放件3 ;及一球囊1，其可插入且膨脹於該支架内'”。 201136574 支架2較仙崎製造，且其構成便於與其内之球囊 時膨脹至-_程度，為可調式，可符合其内膨脹之球囊 且符合其外之血管直徑。當其内之球囊丨緊縮/移除後支架 2不會恢復原狀。其亦可使用生物相容合金、聚合物、及其 它材料取代剛材製造，只要這些材料絲具上述功能。、 置放件3包絡可調式支架2，係以彈性紡織材料製成， 可隨著其内之支架_張而擴張。置放件3結構之基本特 徵為其雜’以峨卷覆或直接包裹該核。於此實施 列置放件3可以具生物相容性之纺織材料，或其它生物 相容之鐵氟龍（商標名）或聚合物製成。 如=1圖所不’支架2與置放件3係連接於支架支持 °支架支持器基本上係三個元件之配置用以置放球囊支 二置放件組件1、2、3於血管内。此配置之組合包括-近 5 ’―遠端軸6 ’及—連接器8，以導線7限定其於血 :2之路桉，球囊1跟隨該導線前進，支架—置放件結構 ^ 、。3圍繞球囊’標記4接於該球囊内以便用X光線偵測 =°進入血管中的球囊支架置放件組件1、2、3係以導 線7引導前進至動脈瘤位置。 々頁施時 ，外展叉罙置放件组件1、2、3前進至動脈 ;=置12_並置於該位置12之最佳區域，如第2圖所示。 =顯不球囊支架置放件組件卜2、3於雜前之狀態。 符人：3圖相應的顯示’球囊1於動脈瘤位置12中膨脹至 勺兩端未患病的血管之直徑，且支架2因其彈性與 外的彈性置放件3也跟著膨脹。膨脹後球囊】，擴張 ^ 2 ’及擴張後置放件3各自之直徑la、2a、3a成為 201136574 由其初始尺寸自然的加大。擴張數量（2a、3a)係以球 之膨脹來調整致使該組件靠在相應之血管壁。 本發明之球囊1，支架2，及置放件3係定形於同 上。沒有軸線未對準情況。然而，軸線位移可能依球囊 的膨脹，動脈瘤的形態，及預定的幾何形狀而產生。 本發明之支架之表層較佳為鋼材或任何其它生物相6 材料應同樣具雜。從而’當支架擴張時其表層 ^ 功能維持不變。 又或 …本發明以膨脹球囊丨而使支架2與包絡支架置放件3 定$ ’不需要複雜之安排即可達成。此外，擴張之程度於 置放於血管之過程可明整，不t要另外的碰手段者 掛釣或夾鍺機制去確保其固定於血管内。 本發明之保護範圍詳述於所附之申請專利範圍中，以 =斤揭露鶴作為說明之用，不能作為本發明之限制。後 顯…、、的’熟悉相關技藝者可使用類似之實施方式及/或 =技術之相似目的應用於其它行業而產生如本揭露之創 因此類此之貫施應用應該是明顯的缺乏創新要件。 【圖式簡單說明】 Ϊ 示本發明之整體結構連同應職置之示意圖。 第3 2林發明之支架置放组件在血管内膨脹前之示意圖 第圖顯示本發明之支架置放組件在血管内膨脹後之示意圖 201136574 【主要元件符號說明】 1 球囊 la 膨脹後球囊 2 支架 2a 膨脹後支架 3 包絡支架置放件 3a 膨脹後包絡支架置放件 4 標記 5 近端軸 6 遠端轴 7. 導線 8 連接器 9 主動脈 10 腎動脈 11 導管 12 動脈瘤病灶 13 腸骨動脈 8201136574 IV. Designated representative map: (1) The representative representative of the case is: (2). (2) Brief description of the symbol of the representative figure: 1 balloon 2 stent 3 envelope stent placement 4 marker 9 aorta 10 renal artery 11 catheter 12 aneurysm lesion 13 intestinal artery 5. If there is a chemical formula in this case, please The present invention relates to a balloon-expandable stent assembly which is enveloped by a fabric or a polymer and which maintains its state after expansion, in particular In the treatment of aneurysms. 201136574 [Prior Art] An aneurysm is a vascular disease that occurs more than 2 cm in diameter on the abdominal artery. In general, in this respect, blood vessel wall enlargement and tearing are formed. When the disease progresses, it will see vascular dissection and rupture events as well as excessive increases in vessel diameter. Vascular diameters of up to 5 cm and rupture events lead to major bleeding and the risk of death. The traditional treatment is the intervention of aneurysm surgery. The part related to the disease was cut open and tried to repair it. The form of the repair operation is not a suture, but a biocompatible member in a tubular form. Although this method is the most widely used procedure in the world, the long duration of treatment and the risk of surgery for elderly patients have increased the use of stents. With regard to stent implantation, many different applications have been developed to place stents in areas where the aneurysm is raised. One such method, as exemplified in U.S. Patent No. Ep7l2614, uses a sleekly designed stent to implant an area of the aneurysm bulge, plus a balloon within the stent. Although according to this disclosure, it is basically an ideal embodiment of the design, not much is mentioned outside the bracket assembly (four). In addition to the lack of disclosure of the inner and outer walls of the stent, the patent has some disadvantages in that the stent is attached to the vascular lesion and secured by hooking. Its most important drawbacks are the degree of help and damage to the vascular structure. In addition, the patent does not describe the elastic structure of the stent. It only mentions that the bracket is fitted with a strong tube to be fixed by hanging fishing. Another: the method of implanting aneurysm stent is to use a self-expanding stent; ^ involves the patented technology of Xuxiang. An essential feature of this stent embodiment is that the stent is placed in a deflated state at the vascular lesion, and the release = elastic branch where a self-ship event occurs. (d) Such a structure may be considered to be theoretically easy, and the introduction of a compact stent tube 201136574 in practical use requires a complicated device and leads to both difficulty in implementation, increase in the inside, and then let it expand to the application. The difficulty in © is difficult. Therefore, the cost. SUMMARY OF THE INVENTION An aneurysm is designed and implemented. A stent system is used in a manner that the compatible fabric 1 can control the expansion of the balloon, and the biological invention of the dragon (?) Any other material is enveloped. Difficult female Α 1", self-expansion or balloon expansion of the stent configuration Zhang = the branch == one system ^ 目 '' 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋This is the state of expansion. As the balloon is supported outside the gold tube, the money is completely dependent on ^ to provide proper fixation there. This function is determined by the fact that the steel is = The material used in the bracket is a fixed-length material, which expands to a == expansion state. In addition, 'use elastic fabric or feather-like material' envelope bracket and bracket tube to move Eliminates the defects encountered in the white technology. If, the best of the valley is the stability of the stent material in expansion or expansion = 4, and elastic materials or similar biocompatible materials The stent is expanded and expanded with the stent when the balloon is inflated. Another advantage is that no complicated hooks or clamps are required to fix the stent in the blood vessel. [Embodiment] The stent placement assembly of the present invention comprises: an expansion type Bracket 2; an envelope stent 3; And a balloon 1, which can be inserted and expanded into the stent '". 201136574 Stent 2 is manufactured by Nissaki and its composition is easy to expand to -_ to the extent of the balloon. It is adjustable to conform to the balloon in which it expands and conforms to the diameter of the blood vessel outside it. The stent 2 does not return to its original state when the balloon therein is tightened/removed. It is also possible to use a biocompatible alloy, a polymer, and other materials instead of a rigid material, as long as these materials have the above functions. , the placement member 3 envelope adjustable bracket 2 is made of elastic textile material and can be expanded with the brackets therein. The basic feature of the structure of the placement member 3 is that it is wrapped or directly wrapped around the core. The placement unit 3 can be made of a biocompatible textile material, or other biocompatible Teflon (trade name) or polymer. For example, if the figure is not 1, the bracket 2 and the placing member 3 are connected to the bracket. The bracket holder is basically configured by three components for placing the balloon holder 2, the components 2, 3, and the blood vessel. Inside. The combination of this configuration includes - near 5 '- distal axis 6' and - connector 8, with wire 7 defining its path to blood: 2, balloon 1 follows the wire, bracket-placement structure ^, . 3 The balloon stent placement assembly 1, 2, 3, which is inserted into the balloon around the balloon' indicia 4 for detection by X-rays, is guided by the guidewire 7 to advance to the aneurysm position. At the time of the squatting, the abduction fork placement components 1, 2, 3 advance to the artery; = 12_ and placed in the optimal area of the position 12, as shown in Figure 2. = The state of the balloon assembly is not known. Furen: 3 correspondingly shows that the balloon 1 is inflated in the aneurysm position 12 to the diameter of the unaffected blood vessel at both ends of the spoon, and the stent 2 is also expanded by the elastic and external elastic member 3. After the expansion of the balloon], the expansion of the 2 2' and the expansion of the placement member 3 each of the diameters la, 2a, 3a become 201136574 by its initial size naturally increased. The amount of expansion (2a, 3a) is adjusted by the expansion of the ball causing the assembly to rest against the corresponding vessel wall. The balloon 1, the stent 2, and the placing member 3 of the present invention are shaped in the same manner. There is no axis misalignment. However, the axial displacement may result from the expansion of the balloon, the morphology of the aneurysm, and the predetermined geometry. The surface layer of the stent of the present invention is preferably steel or any other biological phase 6 material which should be equally complex. Thus, the surface layer function remains unchanged as the stent expands. Alternatively, the present invention can be achieved by expanding the balloon raft so that the stent 2 and the envelope stent 3 can be made without complicated arrangements. In addition, the degree of expansion can be clearly defined in the process of placement in the blood vessel, and it is not necessary to use another means of hanging or fishing to ensure that it is fixed in the blood vessel. The scope of the present invention is described in detail in the appended claims, and is not intended to limit the invention. The familiar artisan can use similar implementations and/or = similar purposes of technology to apply to other industries to produce the application as disclosed. Therefore, the application should be obvious and lack of innovative requirements. . BRIEF DESCRIPTION OF THE DRAWINGS The overall structure of the present invention, together with the schematic diagram of the job application, is shown. The schematic diagram of the stent placement assembly of the invention according to the invention before the intravascular expansion shows the schematic diagram of the stent placement assembly of the present invention after inflation in the blood vessel 201136574 [Description of main components] 1 balloon la after expansion balloon 2 Stent 2a Expanded stent 3 Enveloped stent placement 3a Expanded enveloping stent placement 4 Marking 5 Proximal shaft 6 Distal axis 7. Conductor 8 Connector 9 Aorta 10 Renal artery 11 Catheter 12 Aneurysm lesion 13 Gut Artery 8