201127354 六、發明說明： 【發明所屬之技術領域】 本發明係關於-種新型態之心血管支架，特別是指一種具預防血 管狹窄的心血管支架。 【先前技術】 全球罹患心血管方面疾病的病人，逐年日益增多，其中又以冠狀 動脈血管疾病及頸動脈血管疾病佔了絕大多數，而心血管阻塞、狹窄 化則是造纽亡之最大朗之—。近和血f阻塞、狹窄化之情形多 以氣球擴張技術_1_Angioplasties)搭配血管支架(Stent)來治療，由 於該血管支架係為-彈性體，藉由彈性體本身的支撐力來支持血管 壁，以使血管壁不會因血管組織增生而產生再回復性的阻塞、狹窄現 象。 血管支架是治療聽性心、血m疾病的醫療料，常用的位置 在冠狀動脈和頸紐，其尺寸外徑約為2mm~ 1〇mm和長度約為加 6〇mm，其型式尺寸須由血管阻塞之情況決定；此外，血管支架可應用 於全身各處之血管内壁，如頸動脈血管、膽汁管、食道管'靜脈系統、 輸尿管。钱血管支钱借蛾球導t將血管妓安制婦病變、 阻塞部位，經球囊加壓膨脹的帶動下使其舰，進_狭窄的血管撑 大到足以讓血液可通過的原先正常大小，使閉塞血管得到疏通。但血 管支架植入人體後可能有再狹窄現象發生，植入後的血管支架彈性回 縮、或組織增生皆為再狹窄現象發生原因之一。 201127354 因此，目前研究方向主要針對血管支架之材f改變、或表面藥物 之塗佈，諸如m、鉻錄合金、贿合金 增生藥物之包裹或填覆、或放射化處理等部分進行改良，以降低血管 再狹窄率之發生。此外，本紐明人亦提供—新鶴之血管支架，除 結構新賴外，該結構可賦予其肢管壁上更平均之應力分佈、使其^ 備更佳之支撐效果、及耐疲勞性。 此外’血管支架之用途廣泛，除習知相以治療或預防冠狀動脈 血管阻塞及再狹窄化的可雛外，本案發明人更提供本案心血管支架 之另-制’即可將心血管支架先植入皮下之血管，該位置可供患 者與洗腎顧使用，以聽鶴洗腎所導狀歸老化、組織壞死甚 至無血管可供患者與洗腎機器連結。 因此’本案發明人鑑於上述血管支架之缺失及瓶頸，經多年苦心 孤諸潛心研驗，終於㈣研發完成本件「具驗岭狹窄之心姆 支架」。 【發明内容】 本發明之目的即在於提供-種翻態之心、血管幼，該心血管支 架具預防血管狹窄之功能。 本發明之:欠-目的即在於提供-簡转之新應用係 可供長期洗腎病患與洗腎機所用。 本發明之p目_在於提供—簡顏之心血管核，係具備 更平均之應力分佈、更佳之支撐效果、及耐疲勞性。 201127354 可達成上述發明目的之具預防血管狹窄之心血管支架包括有： 複數個環狀卿私，該微轉單福賴數個雙v形肋骨單 藉由多連減構互相連結域；複數個連接部，該連接部係、包含複 數個連接環單元；該複數個連接部藉由複數個連接環單元將複數個環 狀肋排單元互相連結以—體成形構成具預防血管狹窄之心▲管支架。 【實施方式】 本發明係以下_實施辭以示範義，但本發日林受下述實施 例所限制。 本發明係為-具預防血管狹窄之心血管支架，以下實施例雖用以 說明本案之猶概’細包含本案技術倾之各並不限於本 案所舉之實施例而已’彳壬何義或包含下述技術特徵的心血管支架， 在此皆可併入參考。 本發明之心血管支架係藉由雷射切割毛細管表面使其表面產生 -體成形之網狀肋線結構’同時透過該些網狀肋線結構產生彈性及延 展性。 本發明具麵血管狹窄之心i管支架，其基本結構包含V形肋 骨、多連桿結構及連接環單元，下述先就各基本結構之特徵及連結關 係說明之’再就各基本結構於本案發明人所設計之心血管支架中連結 配置關係進一步說明之。 V形助骨 201127354 〜士請參閱圖一八及圖三所示’分別為本發明心血管支架中之v形肋 、。冓圖及雙v形肋骨單元結構圖，其中該V形肋骨1之兩端點U 刀β別可與夕連桿結構2之第一連桿2a或第二連桿此連結;藉由該多連 之第連杯2a及第二連桿2b分別與第_ V形肋骨la及第二 V形肋骨lb連結，以構成一雙v形肋骨單元私。 另請參閱圖-B，V形肋骨！之長形骨幹12可進—步設置一長形 凹槽13 ’用以填置適用本發明之藥物，以供藥物之釋放。 本發明所述之「V形肋骨」之形狀可包含「V」形、或Γυ」形、φ 或）|於V」形及「υ」形之間適用本發明之設計；而該ν形肋骨J之 頂端14係、為一圓弧滑順之設計，近似Γυ」开)之頂端，非尖銳之設計， 以避免心血管支架產生尖銳處，藉此避免心血管支架對於血管壁產生 不必要之傷害。進一步說明，該v形肋骨i其長形骨幹12至頂端14 所延伸中心線之角度，基本約為2至5度(2~5。）》該V形肋骨丨設計， 經氣囊膨脹後，可使心血管支架之平均應力值較習知所用心血管支架 之平均應力值小。 φ 其中該藥物包含但不限於各類適用本發明之藥物、或物質，如抑 制組織增生之藥物或物質、抑制阻塞之藥物或物質 '放射物質、或其 他具療效及適用本發明用途之藥物或物質。 多連桿結構 請參閱圖二所示，為本發明心血管支架中之多連桿結構圖，該多 連桿結構2包含：一第一連桿2a、一第二連桿2b、一中央橢圓連桿&、 6 201127354 一第一橋接連桿2d及一第二橋接連桿2e，其中該第一連桿2a藉由中 央橢圓連桿2c與第二連桿2b連結、該中央橢圓連桿2C藉由第一連桿 2a與兩側之第—橋接連桿2d連結，以及該中央橢圓連桿2C藉由第二 連桿2b與兩側之第二橋接連桿2e連結，以構成多連桿結構2。該多連 桿結構2像是彈簧結構，除可於氣囊膨脹過程中平均分散應力外，同 時具有補充、加強軸向及徑向之延展能力。 其中該第一橋接連桿2d及第二橋接連桿2e包含半圓形、半弧形或 半拱形之圓弧滑順之設計；一較佳實施例中，當該第一橋接連桿2d及 第二橋接連桿2e為具凹凸面設計時(如：半圓形、半弧形或半拱形之設 計）’該第一橋接連桿2d之凸面2dl與第二橋接連桿2e之凸面2el係 為相對應之配置。 雙V形肋骨單元 另，請參閱圖二及圖三所示，該第一橋接連桿2(1與第二橋接連桿 2e，分別藉由與兩側之多連桿結構2中之第—連桿2a及第二連桿2b 連結，用以橋接各個雙v形肋骨單元44〇 連接環單元 凊參閱圖四A至圖四C所示，為本發明心血管支架中之連接環單 元結構圖及連接示意圖，其中該連接環單S3包含： —連接環3a、一第一切線連接部3b及一第二切線連接部3c，其中 該連接％ 3a係藉由第一切線連接部3b及第二切線連接部允，分別與 兩端之雙V形肋骨單元44之—v形肋骨丨連接，其巾該第__切線連接 201127354 郤3b及第一切線連接部3c，係分別以切線方式或近似切線方式(如切 線箭號所示）’相對平行設置於連接環3a上。該連接環單元3之設計除 可於氣囊職過財平均分散應力外，同時該連接環單元3具有如彈 簧特性，可觀軸向及徑向之延概力，且在彎_血管上可扮演轉 擎器之角色。 另’該連接環皁兀3於本發明令可進一步依切線箭號方向a、順時 針箭號方向b及逆時針箭號方向c，以決定為順向連接環單元3 (請參 閱圖四A所示)或逆向連接環單^3(請參閱圖四b所示）。 前述為本發明心血管支架中各基本單元之設計及相互連結關係之 說明。由於本發，血管核細雷射⑽之材料，以直接形成 一中空網狀圓柱結構，係為_體成形之設計，因此，請參閱以下說明 以明瞭各元件連結關係。 心血管支架 請參閱圖五、圖六及圖七所示，分別為本發明之心血管支架立體 圖、側視圖及展開圖，其中本發明之心血管支架包含： 複數個環狀肋排單元41，該環狀肋排單元41係由複數個雙V形 肋骨單元44藉由多連桿結構2之第—橋接連桿％及第二橋接連料 互相連結而成； 複數個連接部42 ’辆接部42係包含複數贿接環單元3 . 該複數個連接部42藉由複數個連接環翠元3將複數個環狀肋排翠 兀41互相連結以一體成形構成心血管支架4。 201127354 其中該環狀肋排單元之設計數量，可視需要、财_徑之毛細 管柱材料’增減該環狀肋排單元之數量；其中該複數個連接環單元3 可以規則方式或非規則方式將該複數個環狀肋排單元41互相連結。 規則方式 該規則方式包含但视於：（A)财環狀肋排單元41皆統一每間 隔η個雙V形肋骨單元44即配置一連接環單元3，以連結兩環狀肋排 # 單元41之雙V形肋骨單元44,其中η為〇、卜2、3、qn的正整 數；其中當η為0時’表示所有環狀肋排單元41之雙v形肋骨單元 44皆配置連接環單元3，但此種設計該心血管支架*可彎曲度相對較 低、⑼連接部42之連接環單元3皆為順向連接環單元3、（〇連接部 犯之連接環單元3皆為逆向連接環單元3、（D)各連接部42係由相同 規則之順肖連接環單元3及逆向連接環單元3排列組成、(E)各連接部 42雖由不同規則之順向連接環單元3及逆向連接環單以排列組成， • 但最終可形成一具規則之單一支架單元咕請參閱圖七所示I⑻A方 方式(或C D、E方式)之組合’或其他適用本發明之規則排列 方式。 單一支架單元 -較佳實補，請參關七所示，本發明心血管支架係由複數個 相同之早—支架單元43藉由多連桿結構2之第-橋接連桿2d及第二 橋接連桿2e互相連結喊，耻，當欲健心血f支架之賴越大時， 斤南重複之單一支架單元43越多；反之，當欲製備心血管支架之内徑 201127354 越小時，所需重複之單一支架單元43則越少。 該較佳實施例中，請參閱圖七及圖八所示，該單一支架單元Μ包 含：201127354 VI. Description of the Invention: [Technical Field] The present invention relates to a novel cardiovascular stent, and more particularly to a cardiovascular stent for preventing stenosis. [Prior Art] The number of patients suffering from cardiovascular diseases is increasing year by year. Among them, coronary vascular disease and carotid vascular disease account for the vast majority, and cardiovascular obstruction and stenosis are the biggest causes of death. - The condition of proximal and blood f-blocking and stenosis is mostly treated by balloon expansion technique _1_Angioplasties with a stent. Since the stent is an elastic body, the vessel wall is supported by the supporting force of the elastic body itself. In order to prevent the blood vessel wall from accumulating due to vascular tissue, there is a resurgence of occlusion and stenosis. The vascular stent is a medical material for treating auditory heart and blood m disease. The commonly used position is in the coronary artery and the neck. The outer diameter of the stent is about 2mm~1〇mm and the length is about 6〇mm. The size of the stent must be The vascular occlusion is determined; in addition, the vascular stent can be applied to the inner wall of the blood vessel throughout the body, such as the carotid artery, the bile duct, the esophageal tube venous system, and the ureter. The blood vessels of the money support the mothballs to guide the vasculature, the obstruction of the vasospasm, and the obstruction of the vasospasm. The vassal of the stenosis is large enough to allow the blood to pass through. To occlude the occluded blood vessels. However, after the vascular stent is implanted into the human body, there may be restenosis. The elastic retraction of the vascular stent after implantation or tissue hyperplasia is one of the causes of restenosis. 201127354 Therefore, the current research direction is mainly aimed at the modification of the material of the vascular stent f, or the coating of the surface drug, such as m, chromium alloy, briquet or proliferation of drugs, or radiotherapy, to reduce The occurrence of vascular restenosis rate. In addition, the Benxin people also provide the new crane's vascular stent. In addition to the new structure, the structure can give a more even stress distribution on the limb wall, better support effect, and fatigue resistance. In addition, the use of vascular stents is extensive. In addition to the conventional treatment to prevent or prevent coronary vascular occlusion and restenosis, the inventor of the present invention provides the cardiovascular stent in this case. Implanted into the subcutaneous blood vessels, the position can be used by the patient and the dialysis patient to aging, tissue necrosis and even no blood vessels can be connected to the dialysis machine. Therefore, in view of the above-mentioned lack of vascular stents and bottlenecks, the inventors of this case have been painstakingly researched for many years, and finally (4) research and development completed this article "the heart stent with a narrow ridge." SUMMARY OF THE INVENTION An object of the present invention is to provide a heart that is inverted and has a blood vessel that has a function of preventing stenosis of blood vessels. The present invention is characterized in that the under-purpose is to provide a new application system for long-term dialysis patients and dialysis machines. The present invention is to provide a cardiovascular core with a more uniform stress distribution, better support effect, and fatigue resistance. 201127354 The cardiovascular stent for preventing vascular stenosis which can achieve the above object includes: a plurality of ring-shaped scorpions, the plurality of double-v-shaped ribs of the micro-transformed single stalks are connected to each other by multiple subtractive structures; a connecting portion, comprising: a plurality of connecting ring units; the plurality of connecting portions connecting a plurality of annular rib row units to each other by a plurality of connecting ring units to form a body to prevent vascular stenosis support. [Embodiment] The present invention is exemplified by the following examples, but the present invention is limited by the following examples. The present invention is a cardiovascular stent for preventing vascular stenosis. The following examples are used to illustrate the details of the present invention. The details of the present invention are not limited to the embodiments of the present invention. Cardiovascular stents of the following technical features are hereby incorporated by reference. The cardiovascular stent of the present invention is formed by laser cutting the surface of the capillary to produce a body-formed mesh rib structure' while producing elasticity and ductility through the mesh rib structure. The basic tube structure of the invention has a V-shaped rib, a multi-link structure and a connecting ring unit. The following describes the characteristics and the connection relationship of each basic structure. The connection configuration relationship of the cardiovascular stent designed by the inventor of the present invention is further explained. V-shaped bone assist 201127354 ~ ~ See Figure 18 and Figure 3 respectively, respectively, the v-shaped rib in the cardiovascular stent of the present invention.冓 及 双 双 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及 及The continuous cup 2a and the second link 2b are coupled to the V-shaped rib 1a and the second V-shaped rib lb, respectively, to form a double V-shaped rib unit. See also Figure-B, V-shaped ribs! The elongate backbone 12 can be stepped into an elongate recess 13' for filling the drug of the present invention for release of the drug. The shape of the "V-shaped rib" of the present invention may include a "V" shape, or a Γυ" shape, φ or )| between the V" shape and the "υ" shape to apply the design of the present invention; and the ν-shaped rib The top 14 of J is designed as a smooth arc, which is similar to the top of the Γυ"open". It is not sharply designed to avoid sharp points in the cardiovascular stent, thereby avoiding unnecessary cardiovascular stents for the vessel wall. hurt. Further, the angle of the center line extending from the elongate backbone 12 to the tip end 14 of the v-shaped rib i is substantially about 2 to 5 degrees (2 to 5.). The V-shaped rib design is designed to be expanded by the airbag. The average stress value of the cardiovascular stent is smaller than the average stress value of the conventional cardiovascular stent. Φ wherein the drug includes, but is not limited to, various drugs, or substances, which are suitable for use in the present invention, such as drugs or substances that inhibit tissue proliferation, drugs or substances that inhibit occlusion, 'radiation materials, or other drugs that have therapeutic effects and are suitable for use according to the present invention or substance. The multi-link structure is shown in FIG. 2, which is a multi-link structure diagram of the cardiovascular stent of the present invention. The multi-link structure 2 includes: a first link 2a, a second link 2b, and a central ellipse. Connecting rod &, 6 201127354 a first bridging link 2d and a second bridging link 2e, wherein the first connecting rod 2a is coupled to the second connecting rod 2b by a central elliptical link 2c, the central elliptical connecting rod 2C is coupled to the first bridge link 2d on both sides by the first link 2a, and the central elliptical link 2C is coupled to the second bridge link 2e on both sides by the second link 2b to form a multi-connection Rod structure 2. The multi-link structure 2 is like a spring structure, in addition to the average dispersion stress during the expansion of the airbag, and at the same time has the ability to supplement and strengthen the axial and radial extension. Wherein the first bridging link 2d and the second bridging link 2e comprise a semicircular, semi-arc or semi-arched arc smooth design; in a preferred embodiment, when the first bridging link 2d And the second bridging link 2e is designed with a concave-convex surface (such as a semi-circular, semi-arc or semi-arched design) 'the convex surface 2dl of the first bridging link 2d and the convex surface of the second bridging link 2e 2el is the corresponding configuration. Double V-shaped rib unit, please refer to FIG. 2 and FIG. 3, the first bridge link 2 (1 and the second bridge link 2e, respectively, by the multi-link structure 2 on both sides) The connecting rod 2a and the second connecting rod 2b are connected to bridge each double v-shaped rib unit 44. The connecting ring unit is shown in FIG. 4A to FIG. 4C, which is a structural diagram of the connecting ring unit in the cardiovascular stent of the present invention. And the connection diagram S3, wherein the connection ring S3 comprises: a connection ring 3a, a first tangential connection portion 3b and a second tangential connection portion 3c, wherein the connection % 3a is connected by the first tangential connection portion 3b and The second tangential connection portion is respectively connected to the v-shaped ribs of the double V-shaped rib unit 44 at both ends, and the first _ tangential connection 201127354 but 3b and the first tangential connection portion 3c are respectively tangent The mode or the approximate tangential manner (as indicated by the tangential arrow) is disposed relatively parallel to the connecting ring 3a. The design of the connecting ring unit 3 is not limited to the average dispersion stress of the airbag, and the connecting ring unit 3 has the same Spring characteristics, appreciable axial and radial extension, and can be used on the bend The role of the actuator is as follows. In addition, the connection ring saponin 3 can be further determined by the tangential arrow direction a, the clockwise arrow direction b and the counterclockwise arrow direction c to determine the forward connection ring unit. 3 (please refer to Figure 4A) or reverse-connecting ring single ^3 (please refer to Figure 4b). The foregoing is a description of the design and interconnection of the basic units in the cardiovascular stent of the present invention. The material of the fine nuclear laser (10) is a direct formation of a hollow mesh cylindrical structure, which is designed for the formation of the body. Therefore, please refer to the following description to clarify the connection relationship of the components. Refer to Figure 5 for the cardiovascular stent. 6 and FIG. 7 are respectively a perspective view, a side view and a development view of the cardiovascular stent of the present invention, wherein the cardiovascular stent of the present invention comprises: a plurality of annular rib row units 41, the annular rib row unit 41 being The plurality of double V-shaped rib units 44 are interconnected by the first bridge link % and the second bridge link of the multi-link structure 2; the plurality of connecting portions 42 'the connecting portion 42 includes a plurality of bribe ring units 3. The plurality of connecting portions 42 borrow A plurality of annular ribs 兀 兀 41 are connected to each other to form a cardiovascular stent 4 by a plurality of connecting rings Cuiyuan 3. 201127354 wherein the number of the annular rib row units is designed, the capillary column can be used as needed The material 'increases or decreases the number of the annular rib row units; wherein the plurality of connecting ring units 3 can connect the plurality of annular rib row units 41 to each other in a regular manner or in an irregular manner. The rule mode includes but : (A) the financial annular rib row unit 41 is unified with each of the n double V-shaped rib units 44, that is, a connecting ring unit 3 is disposed to connect the double V-shaped rib units 44 of the two annular rib rows # unit 41, wherein η is a positive integer of 〇, 卜 2, 3, qn; wherein when η is 0, 'the double v-shaped rib elements 44 representing all the annular rib row units 41 are configured to connect the ring unit 3, but this design is cardiovascular The bracket* has a relatively low degree of curvature, and (9) the connecting ring unit 3 of the connecting portion 42 is a forward connecting ring unit 3, (the connecting ring unit 3 of the connecting portion is a reverse connecting ring unit 3, and (D) each connection The part 42 is connected by the same rule of the ring connecting ring unit 3 and The reverse connection ring unit 3 is arranged in an array, and (E) each of the connection portions 42 is composed of a different regular forward connection ring unit 3 and a reverse connection ring in a single arrangement, but can finally form a single unit with a regular rule. Figure 7 shows the combination of the I(8)A side mode (or CD, E mode) or other rule arrangement in which the present invention is applied. Single bracket unit - preferably complemented, as shown in Figure 7, the cardiovascular stent of the present invention is composed of a plurality of identical early-bracket units 43 by the first-bridge link 2d and the second bridge of the multi-link structure 2 The connecting rods 2e are connected to each other and shy. When the desire to be healthy, the more the single bracket unit 43 is repeated; on the contrary, the smaller the inner diameter of the cardiovascular stent is to be prepared, the smaller the inner diameter 201127354 is. The fewer the single bracket unit 43 is. In the preferred embodiment, referring to FIG. 7 and FIG. 8, the single bracket unit includes:
五個環狀肋排單元41a至41e，各環狀肋排單元41係由六個雙V 形肋骨單元44分職由彼狀Μ桿結構2之第—橋接連桿如及第 二橋接連桿2e互相連結而成； 四個連接42a至42d ’各連接部42皆由兩個連接環單元3所組 成’用以連接各環狀肋排單元4卜以形成該單一支架單元43 ; 其中第-肋排單it 41a之第-雙v形肋骨單元431及第四雙v形 肋月單元434 ’分別藉由第一連接部42a之順向連接環單元3及逆向連 接環早兀3與第二肋排單元仙之第一雙v形肋骨單元431及第四雙 V形肋骨單元434連結； 其中第二肋排單元41b之第二雙v形肋骨單元432及第五雙v形 肋月單元435分別再藉由第二連接部42b之逆向連接環單元3及順向 連接壤單兀3與第三肋排單元价之第二雙v形肋骨單元432及第五 雙V形肋骨單元435連結； 其中第三肋排單元4卜之第一雙V形肋骨單元431及第四雙V形 肋月單元434刀別再藉由第三連接部42c之順向連接環單元3及逆向連 接壞單το 3與第四肋排單元41d之第一雙v形肋骨單元431及第四雙 V形肋骨單元434連結； 其中第四肋排單元41d之第二雙V形肋骨單元432及第五雙V形 肋骨單兀435分別再藉由第四連接部42d之順向連接環單元3及逆向 201127354 連接環單元3與第五肋排單元41e 雙V形肋骨單元435連結。 之第二雙V形肋骨單元432及第五 另—較佳實施例，請參閱圖九所+ , ，本發明之心血管支架4中之 各環狀肋排單元41係藉由相同之連接部42連結而成，其中各環狀肋 排単元41皆以每間隔兩健v形肋骨單元44之規則，即配置一逆向 連接環單元3，⑽連結各雜鱗單元41。Five annular rib row units 41a to 41e, each annular rib row unit 41 is divided by six double V-shaped rib units 44 by the first-bridge link of the other-shaped mast structure 2, and the second bridge link 2e are connected to each other; four connections 42a to 42d 'each of the connecting portions 42 are composed of two connecting ring units 3' for connecting the annular rib row units 4 to form the single bracket unit 43; The first-double v-shaped rib unit 431 and the fourth double-v-shaped rib unit 434' of the rib row unit 41a are respectively connected to the ring unit 3 and the reverse connection ring by the first connecting portion 42a, respectively, 3 and 2 The first double v-shaped rib unit 431 and the fourth double V-shaped rib unit 434 of the rib row unit are connected; wherein the second double v-shaped rib unit 432 and the fifth double v-shaped rib unit 435 of the second rib row unit 41b The second double v-shaped rib unit 432 and the fifth double V-shaped rib unit 435 are connected to each other by the reverse connecting ring unit 3 of the second connecting portion 42b and the forward connecting land unit 3 and the third rib row unit price; The first double V-shaped rib unit 431 and the fourth double V-shaped rib unit 434 of the third rib row unit 4 are further connected by a third connection The forward connecting ring unit 3 of 42c and the reverse connecting bad unit το 3 are coupled with the first double v-shaped rib unit 431 and the fourth double V-shaped rib unit 434 of the fourth rib row unit 41d; wherein the fourth rib row unit 41d The second double V-shaped rib unit 432 and the fifth double V-shaped rib unit 435 are respectively connected to the ring unit 3 and the reverse 201127354 by the fourth connecting portion 42d. The ring unit 3 and the fifth rib unit 41e are double V. The ribbed unit 435 is coupled. For the second double V-shaped rib unit 432 and the fifth alternative embodiment, please refer to FIG. 9 +, the annular rib row unit 41 of the cardiovascular stent 4 of the present invention is connected by the same connection portion. 42 is connected, wherein each of the annular rib rows 41 is arranged with a regular v-shaped rib unit 44, that is, a reverse-connecting ring unit 3 is disposed, and (10) is connected to each of the scaly units 41.
非規則方式 該非規财式包含但稀於：（A)財雜肋排單元41皆非統一 間:個雙v形肋骨單元44配置一連接環單元3，可視需求調整該連 接環單ϋ 3之配置位置，以連結兩驗轉單元4ι之雙v形肋骨單元 糾’其^以小^一^的正整數⑼各連接料係由不 同規則之軸連接環單％ 3及逆向連接環單元3排顺成，且最終不 形成-具規則之單-支架料43，但最終仍需維持形成—心血管支架 之適用相互連結關係、、（c) Α方式及Β方式之板合、或其他適用本發 明之非規則排列方式。 血管支架之設計 〜血管支架之網孔的形狀和面積大小，將影響側枝血管的供血， 而心血官支架網孔的形狀有開窗設計(open cell，指窗口面積在支架彎 曲時不發生變化）’和閉窗設計(cl〇se ceU，指窗口面積隨支架弯曲而變 化）’開窗設計可增加側枝通過性，且在擴張後易彎曲，順應性好。因 此，凊參閱圖七所示，本發明之心血管支架亦設有開窗設計51 (點狀區 201127354 域)及閉窗設計52(斜線區域），以供該心血管支架於擴張後易彎曲且順 應性佳。 心血管支架材料 本發明用於製備心血管支架之適用且兼具生物相容性 (biocompatible)之材料，包含但不限於：⑴金屬材料(Μ_，如钽絲、 不鏽鋼(如本發明所佔用材料之一：醫療級SUS316L/LN不細）、钻 鎳翻合金、織鈦合金等、⑵高分子生物材料㈣麵），如鐵弗龍、 DPE PMMA等材質、⑶陶兗材料與複合材料仰叫⑽此 materials)、（4)生物可降解性材料(Bi〇degradable腦防她）、⑶醫用 材質或其他適財發明之材料。其中（3)陶㈣料與複合材料 (Composite __包含⑻生物惰性陶究材料，該材料於植入人體 後，不會與人翁纽應’如氧傾、氧化料；⑼生物活性陶曼材 料’該材料植人後會與人體發生反應，如氫氧做石、三_灰鹽等。 其中⑶複合材料由兩種或兩種以上不同的材料所組成，利用不同的材 料特性互相麵，如碳複合材料、_触複合㈣。其巾⑷生物可 降解性材娜〇degradable materials)係利用__ 作〜血官支架’同時該生物類型的^血管支架能在體内自動消失；所 以又稱其為生轉雜聚合—管該；如料魏合雌雄池 —’簡冑PLA )或稱聚乳酸可分解塑膠、匕形式聚乳酸 (Poly(L-lactide)，簡稱 PLLA)等。 心血管支架之製程 12 201127354 請參閱圖十之韻流棚，本翻之心血管支架之製備方法、機 具或尺寸，包含但不限於： 步驟一：雷射切割 根據本發明賴計的各元侧纽其奴關奴卿設計，於該 毛細管金屬材料上以適狀ϋ具切割出所需的贿；如：利用高聚合 力和高溫之雷射於材料表面加工，以形成網狀支架肋線（骨）、連接環、 多連桿結構等元件。 步驟二：超音波處理 心企管支架在拋歧理前，需要通過超音波水缝_去除因雷 射切割所產生之毛邊和連桿上之溶心烘乾後再浸人配製的酸液中， 以去除表面氧化層及其他污染物。 步驟三··拋光處理 心血管支架的表面粗會影響血栓和血管_之反應，如臨床 後之血f内膜增生反應、抵抗發炎能力及相容性等，將影響支架 之性能及可祕。_化學抛光或電馳光的方法，可肋去除因雷 射切《j所產生之毛邊、連桿上之溶潰、及徑向粗輪加工面，使其表面 、”田緻化和平坦化’即可得到本發明之具預防血管狹窄^血管支架。 本發明之驗血管狹窄^血管支架之製程，可進—步視需要包含 下述步驟’如：整圓加工、塗覆步驟、滅菌處理等步驟。 其中： 塗覆步驟： 該血管支架可進—步在内外表面上喷塗一層混有藥物之生物可降 13 201127354 解吸收關料’藉此在血管支架植人人體後，可使藥物慢速釋放出來， 以降低血管之二次1«的可能性。 滅菌處理： 由於心血管支架於製備後仍殘留化學物質或其他污染，而該些污 染會影響後續消毒或滅菌的效果，因此，將製備好之心血管支架需於 滅菌及轉前進行清洗，再進行後續滅 菌及消毒。 常用之消毒方法包含：係以高程度消毒酿滅非芽孢的微生物， 即可殺死細_繁聽、結核S、黴S及病毒；-般赫咖至少20 分鐘；酒精殺細菌濃度範圍為敝90%(v/v)，一般使用為漠度 70%(v/v)°含有機物時會降低其《侧，會使皮膚乾燥及刺激感，對 黏膜有傷害》 常用之滅菌方式包含： (一) 蒸氣減菌121t : 滅菌週期時間短，約45~75分鐘，對環境無毒性，滅菌鋼容量大， 不L用於不耐熱或不耐濕之物品，無法對粉類或油劑物品進行滅菌。 (—)放射線滅菌： 利用γ-ray或p-ray之離子化過程的能量轉變成熱及化學能，破壞 /政生物的if傳因子DNA，以達到殺死微生物的效果。離子放射線穿透 力尚’價格昂貴，須特殊儀H、裝備及防護措施。 (二) 低溫電漿滅菌： 於真空狀||下，棚電波能制激極度活化的氣體，使離子與分 子互相碰撞產生自&基，破概生崎陳代賴功能。可在低於抓 201127354 下進行滅菌，須使用特殊材質包裝。對環境無毒性殘存(氧氣及水），滅 菌週期短，55~75分鐘’可處理不耐熱及不耐濕的醫療器材。不適用於 植物纖維製品、布單、液體或粉類的滅菌，滅菌鋼之容量不大，因為 滲透力差，對滅菌物品的管徑與長度有限制。 心血管支架表面處理方式 由於心血管支架係直接與人體之血管壁接觸，因此，該心血管支 架之表面應f盡可能之滑順’故，經雷射蝴製程或其他製程方式所 製備之心血管支架，皆需進行適當之表面拋光處理(surface _shing process)，以使該心血管支架之表面光滑平順。 習知之表面處理方式，除可使血管支架表面光滑外，更使其兼具 治療用途，及具更佳之抗氧化、抗雜、更佳之生物相容性等功效。 本發明之血管支架亦可適綴各類表面處理方式，包含但不限於裸 路型、塗層型、覆膜型、化學拋光或電解拋光等表面處理方式。其中 裸露型的‘ϋ管支架是在其表面僅作拋光處理；其巾塗層型的心血管 支架即是在其心血管支架的表面塗佈一層薄的藥物，以減少血检形 成；其中覆膜型的心血管支架即是在其心血管支架的表面覆被聚合物 之薄膜；其中電解拋光可藉由雷射多次處理或高熱處理支架，使其更 趨光滑平坦，靴學電解減之拋光方式係藉由朗德學物質進行 抛光。 血管支架使用狀態 請參閱圖十-所示，為本發明心血管支架4配置於血管壁$之使 201127354 用狀態圖’本發明之心血f支架4可藉由雙v形肋骨單元則以支持 血官壁’ ^由於各連結部42係由複數個連接環3所構成，藉此扮演轉 擎器之角色’可使心血管支架如—彈性體般具轉折彎曲之功能，可使 該〜血支架適於安裝在不同形狀、不同彎曲程度之血管。 凊參閱圖十二所示，林發明心血管支練氣麟開後之展開示 意圖’其中各元件由於—體成形且該網狀肋線結構具彈性及延展性， 因此，經氣鱗開後各元件之雜或姆距鮮會拉卩猶大(如箭頭方 向所示），如兩連接環單元3之間、兩雙v形肋骨單元43之間之距離 皆會拉大’除可用以支標血管壁外，亦可視不同内徑之血管不同狹 窄程度之血相整制之。本發明之d管支架經氣麟開後，經測 量，其直徑可撐開約2.8 ~ 8 mm。 本發明之心血管支架除可應用於常用之冠狀動脈和頸動脈外，亦 可應用於全身各處之血管内壁，如頸動脈血管、膽汁f、食道管、靜 脈系統、輸尿管等《•此外，本發明更提供該新穎心血管支架之新應用， 係供長期洗腎患者及洗腎機輯用’藉由將賴穎心、血管支架先置放 皮下之血管，藉驗置可供患者及錄機紐結，以避免長期侵入性 治療所導狀A管統 ' 組_鱗辟。而本發明之心血管支架之 尺寸、内徑可視需要調整之，如：可依血管阻塞之情況決定之、依血 管内徑不同而調整。 本發明之‘V·*血管支架經應力分佈分析、疲勞性分析、支標效果分 析，減雖者’齡本㈣者更具平均之應力分佈、更佳之支樓效 201127354 果、及耐疲勞性。 上列詳細說明係針對本發明之一可行實施例之具體說明，惟該實 施例並非肋_本㈣之糊制，凡未脫縣發顺藝精神所為 之等效實施或變更，均應包含於本案之專利範圍中。 綜上所述，本料但在血管支架之結射制新，較習用血 管支架增進多種功效，應已充分符合新穎性及進步性之法定發明專利 要件’纽法提出申請，懇請貴局核准本件發明專利申請案，以勵 發明，至感德便。 【圖式簡單說明】 圖- A為本發明心騎支架#之v形肋骨結構圖；圖—B為該v 形肋骨上進一步加工一長形凹漕，以供藥物填覆。 圖二為本發明心血管支架中之多連桿結構圖。 圖二為本發明心血管支架中之雙v形肋骨單元結構圖。 圖四A為本發明心血管支架中之順向連接環單元結構圖；圖四b 為本發明心血管支架中之逆向連接環單元結構圖；圖四c為順向連接 環單元與兩端之雙V形肋骨單元連結之示意圖。 圖五為本發明心企管支架之立體圖。 圖六為本發明心血管支架之側視圖。 圖七為本發明心血管支架之平面展開圖。 圖八為本發明心血管支架中之單一支架單元平面展開圖。 圖九為本發明心血管支架另一型態之平面展開圖’其中該連接環 17 201127354 部分皆為逆向連接環單元。 圖十為本發明心血管支架之製備流程圖。 圖十-為本發日細血管支架安裝於血管壁之使脉態圖。 圖十二為本發明心血管支架經❸«外力刺後之延展示意圖， 其中箭號方向表示因外力而撐開之方向。 [ 主要元件符號說明】 1 V形肋骨 4 心血管支架 11 端點 41 環狀肋排單元 12 長形骨幹 41a 第一環狀肋排單元 13 長形凹槽 41b 第二環狀肋排單元 14 頂端 41c 第三環狀肋排單元 la 第一 V形肋骨 41d 第四環狀肋排單元 lb 第一 V形肋骨 41e 第五環狀肋排單元 2 多連桿結構 42 連接部 2a 第一連桿 42a 第一連接部 2b 第二連桿 42b 第二連接部 2c 中央橢圓連桿 42c 第三連接部 2d 第一橋接連桿 42d 第四連接部 2dl 第一橋接連桿之凸面 43 單一支架單元 2e 第二橋接連桿 431 第一雙V形肋骨單元 2el 第—橋接連桿之凸面 432 第二雙V形肋骨單元Irregularly, the non-standard financial formula includes but is sparse: (A) the financial rib row unit 41 is non-uniform: a double v-shaped rib unit 44 is configured with a connecting ring unit 3, and the connecting ring unit can be adjusted as needed. The position is arranged to connect the two v-shaped rib units of the two verification units 4 ι to correct the positive integers of the small ^ 1 ^ (9) each connecting material is connected by a different rule of the shaft ring 3 % and the reverse connection ring unit 3 Shuncheng, and ultimately does not form a regular single-scaffold material 43, but ultimately still need to maintain the formation of the cardiovascular joints, the (c) Α Β Β 、 、, or other applicable The irregular arrangement of the invention. The design of the vascular stent ~ the shape and size of the mesh of the vascular stent will affect the blood supply of the collateral vessels, and the shape of the mesh of the blood vessel official stent has a window design (open cell, the window area does not change when the stent is bent) 'and closed window design (cl〇se ceU, refers to the window area changes with the bracket bending) 'window design can increase the side branch through, and easy to bend after expansion, good compliance. Therefore, as shown in FIG. 7, the cardiovascular stent of the present invention is also provided with a fenestration design 51 (point region 201127354 domain) and a closed window design 52 (slash region) for the cardiovascular stent to be easily bent after expansion. And the compliance is good. Cardiovascular scaffold material The material of the present invention for preparing a cardiovascular stent is biocompatible, including but not limited to: (1) metal material (Μ, such as silk, stainless steel (such as the material occupied by the present invention) One: medical grade SUS316L/LN is not fine), drilled nickel alloy, woven titanium alloy, etc., (2) polymer biomaterial (four) surface, such as Teflon, DPE PMMA and other materials, (3) ceramic materials and composite materials (10) This materials), (4) biodegradable materials (Bi〇degradable brain prevention), (3) medical materials or other materials for the invention. Among them, (3) pottery (four) materials and composite materials (Composite __ contains (8) bio-inert ceramic materials, after the material is implanted into the human body, it will not be treated with humans, such as oxygen, oxidizing materials; (9) biologically active Taoman Material 'The material will react with the human body after planting, such as oxyhydrogen stone, tri-grey salt, etc. Among them (3) composite material consists of two or more different materials, using different material properties to each other, Such as carbon composite materials, _ touch composite (four). Its towel (4) biodegradable materials Naru degradable materials) using __ ~ blood official stent 'the biological type of vascular stent can automatically disappear in the body; so It is called a bio-heterogeneous polymer-tube; for example, Weihe male and female pools - 'simplified PLA' or polylactic acid decomposable plastic, poly(L-lactide), PLLA for short. The process of cardiovascular stent 12 201127354 Please refer to Figure 10 rhyme flow shed, the preparation method, machine or size of the cardiovascular stent, including but not limited to: Step 1: Laser cutting according to the side of each side of the invention Designed by Nuchino Guan Nuqing, the required bribes are cut out on the capillary metal material by means of suitable cookware; for example, high-polymerization and high-temperature laser are applied to the surface of the material to form the mesh support rib line ( Bone), connecting ring, multi-link structure and other components. Step 2: Ultrasonic processing of the core tube bracket before the throwing of the ambiguity, the need to pass the ultrasonic water seam _ remove the burrs generated by the laser cutting and the melting point on the connecting rod to dry and then dip into the acid solution To remove surface oxides and other contaminants. Step 3 · Polishing The surface of the cardiovascular stent will affect the response of the thrombus and blood vessels, such as the intimal hyperplasia, anti-inflammatory ability and compatibility of the blood, which will affect the performance and the secret of the stent. _Chemical polishing or electro-lighting method, the rib can remove the burrs generated by the laser, the crater generated by j, the melting on the connecting rod, and the surface of the radial rough wheel to make the surface, "Tianzhihua and flattening 'The blood vessel stenosis preventing vascular stent of the present invention can be obtained. The process for testing the vascular stenosis vascular stent of the present invention can be carried out in the following steps, such as: round processing, coating step, sterilization treatment Steps: Among them: Coating step: The vascular stent can be sprayed on the inner and outer surfaces to spray a layer of drug-mixed organisms to fall 13 201127354 to absorb the absorption material, thereby allowing the drug to be implanted in the human body after the stent is implanted Slowly released to reduce the possibility of secondary vascularization. Sterilization: Since the cardiovascular stent remains chemical or other contamination after preparation, these contaminations may affect the subsequent disinfection or sterilization effect. The prepared cardiovascular stent needs to be cleaned before sterilization and before being transferred, and then subjected to subsequent sterilization and disinfection. Commonly used disinfection methods include: disinfecting non-spore microorganisms with high degree of sterilization, Dead _ _ listen, tuberculosis S, mildew S and virus; - like Hera at least 20 minutes; alcohol killing bacteria concentration range 敝 90% (v / v), generally used for indifference 70% (v / v) ° When it contains organic matter, it will reduce its side, which will make the skin dry and irritating, and it will hurt the mucous membrane. Commonly used sterilization methods include: (1) Vapor reduction 121t: Sterilization cycle time is short, about 45~75 minutes, non-toxic to the environment Sex, sterilized steel has a large capacity, not used for items that are not heat-resistant or moisture-resistant, and cannot sterilize powder or oil items. (-) Radiation sterilization: Using γ-ray or p-ray ionization process The energy is transformed into heat and chemical energy, destroying the underlying factor DNA of the political organism to achieve the effect of killing the microorganisms. The ionizing radiation penetration is still expensive, requires special instrument H, equipment and protective measures. Plasma sterilization: Under vacuum ||, the shed wave can stimulate the extremely activated gas, causing the ions and molecules to collide with each other to produce the self- & base, breaking the function of the sakisaki yakudai. It can be carried out under the scratch of 201127354. Sterilization, must be packaged in special materials, no toxicity to the environment (oxygen Gas and water), short sterilization cycle, 55~75 minutes' can handle heat-resistant and moisture-resistant medical equipment. It is not suitable for sterilization of plant fiber products, cloth sheets, liquids or powders. The capacity of sterilized steel is not large. Because of the poor penetrating power, there are restrictions on the diameter and length of the sterilized articles. The surface treatment method of the cardiovascular stent Because the cardiovascular stent is directly in contact with the blood vessel wall of the human body, the surface of the cardiovascular stent should be as smooth as possible. 'Therefore, the cardiovascular stent prepared by the laser butterfly process or other process methods needs to be properly surface _shing process to make the surface of the cardiovascular stent smooth and smooth. In addition to smoothing the surface of the vascular stent, it has both therapeutic use and better anti-oxidation, anti-hybrid, and better biocompatibility. The blood vessel stent of the present invention can also be applied to various surface treatment methods, including but not limited to surface treatment methods such as bare type, coated type, coated type, chemical polishing or electrolytic polishing. Among them, the bare-type 'tube holder is only polished on its surface; its towel-coated type of cardiovascular stent is coated with a thin layer of drug on the surface of its cardiovascular stent to reduce blood test formation; The membrane type cardiovascular stent is a film coated with a polymer on the surface of the cardiovascular stent; wherein the electropolishing can be made more smooth and flat by laser multiple treatment or high heat treatment stent, and the electrolysis is reduced. The polishing method is performed by the Langde material. For the state of use of the blood vessel stent, please refer to FIG. 10 - the cardiovascular stent 4 of the present invention is disposed on the blood vessel wall. The state of the present invention is shown in the state of the art. The blood vessel of the present invention can be supported by the double v-shaped rib unit. The official wall ' ^ because each connecting portion 42 is composed of a plurality of connecting rings 3, thereby playing the role of the steering device, the cardiovascular stent can be bent and bent like an elastic body, and the blood stent can be made. Suitable for installation in blood vessels of different shapes and different degrees of curvature.凊Refer to Figure 12, the invented schematic diagram of the invention of the cardiovascular training after the opening of the lining of the forest. The components are formed by the body and the ribbed structure is elastic and malleable. Therefore, after the gas scale is opened, The miscellaneous or the distance of the components will be too large (as indicated by the direction of the arrow). For example, the distance between the two connecting ring units 3 and the two pairs of v-shaped rib elements 43 will be widened. Outside the wall, it is also possible to use different blood vessels of different inner diameters to complete the blood phase. The d-tube stent of the present invention can be expanded by about 2.8 to 8 mm after being measured by gas tunneling. The cardiovascular stent of the invention can be applied to the common coronary artery and carotid artery, and can also be applied to the inner wall of the blood vessel, such as carotid artery blood vessel, bile f, esophageal tube, venous system, ureter, etc. The invention further provides a new application of the novel cardiovascular stent, which is used for long-term dialysis patients and dialysis machines to use the blood vessel by placing the Lai Yingxin and the vascular stent under the skin. Machine knots to avoid long-term invasive treatment guided by the A-tube _ scale. The size and inner diameter of the cardiovascular stent of the present invention may be adjusted as needed, for example, depending on the condition of the vascular occlusion, and adjusted according to the inner diameter of the blood vessel. The stress distribution analysis, fatigue analysis, and branch effect analysis of the 'V·* vascular stent of the present invention reduce the average stress distribution, better support effect, and fatigue resistance of the 'V•* vascular stents. . The detailed description above is a detailed description of one of the possible embodiments of the present invention, but the embodiment is not a paste of the present invention, and the equivalent implementation or modification of the spirit of the company should be included in The patent scope of this case. In summary, this material, but in the vascular stent for the new system, compared with the conventional vascular stent to enhance a variety of effects, should be fully in line with the novelty and progressive legal invention patent requirements 'New Law to apply, I ask you to approve this Invention patent application, in order to invent invention, to the sense of virtue. BRIEF DESCRIPTION OF THE DRAWINGS Fig.-A is a v-shaped rib structure diagram of the heart riding bracket # of the present invention; Fig. B is a further processing of an elongated concave ridge on the v-shaped rib for drug filling. Figure 2 is a multi-link structure diagram of the cardiovascular stent of the present invention. Figure 2 is a structural view of a double v-shaped rib unit in the cardiovascular stent of the present invention. Figure 4A is a structural view of a forward connecting ring unit in the cardiovascular stent of the present invention; Figure 4b is a structural diagram of a reverse connecting ring unit in the cardiovascular stent of the present invention; Figure 4c is a forward connecting ring unit and both ends Schematic diagram of the connection of double V-shaped rib units. Figure 5 is a perspective view of the heart-shaped tube support of the present invention. Figure 6 is a side view of the cardiovascular stent of the present invention. Figure 7 is a plan view of the cardiovascular stent of the present invention. Figure 8 is a plan development view of a single stent unit in the cardiovascular stent of the present invention. Figure 9 is a plan view showing another embodiment of the cardiovascular stent of the present invention. The portion of the connecting ring 17 201127354 is a reverse connecting ring unit. Figure 10 is a flow chart of the preparation of the cardiovascular stent of the present invention. Figure 10 - The pulse diagram of the vascular stent mounted on the vessel wall. Fig. 12 is a schematic view showing the extension of the cardiovascular stent after the external force of the invention, wherein the direction of the arrow indicates the direction of expansion due to external force. [Main component symbol description] 1 V-shaped rib 4 Cardiovascular stent 11 End point 41 Annular rib row unit 12 Long shaft 41a First annular rib row unit 13 Long groove 41b Second annular rib row unit 14 Top 41c third annular rib row unit la first V-shaped rib 41d fourth annular rib row unit lb first V-shaped rib 41e fifth annular rib row unit 2 multi-link structure 42 connecting portion 2a first link 42a First connecting portion 2b second link 42b second connecting portion 2c central elliptical link 42c third connecting portion 2d first bridging link 42d fourth connecting portion 2d1 convex surface of first bridging link 43 single bracket unit 2e second Bridge link 431 first double V-shaped rib unit 2el first - bridge joint convex surface 432 second double V-shaped rib unit
18 201127354 3 連接環單元 433 第三雙V形肋骨單元 3a 連接環 434 第四雙V形肋骨單元 3b 第一切線連接部 435 第五雙V形肋骨單元 3c 第二切線連接部 436 第六雙V形肋骨單元 a 切線箭號方向 44 雙V形肋骨單元 b 順時針箭號方向 51 開窗設計 c 逆時針箭號方向 52 閉窗設計 1918 201127354 3 Connecting ring unit 433 Third double V-shaped rib unit 3a Connecting ring 434 Fourth double V-shaped rib unit 3b First line connecting portion 435 Fifth double V-shaped rib unit 3c Second tangential connecting portion 436 Sixth double V-shaped rib unit a Tangential arrow direction 44 Double V-shaped rib unit b Clockwise arrow direction 51 Window design c Counterclockwise arrow direction 52 Closed window design 19