200948406 六、發明說明： 【發明所屬之技術領域】 本發明係有關於一種注射器單元’其可結合於一注射裝置作為醫 療用途，特別是用以灌注流體藥品》 【先前技術】 注射器裝置在習知技術領中已經被廣泛得知，特別是可設置於注 射裝置來藉由使用者本身加以使用，舉例來說，如歐洲專利第1 483 004 B1號專利揭露一種注射器單元，其包含有注射器以及注射器支持 — 器’其中注射器單元由注射器支持器兩側向外突出，換句話說，分別 在近端方向以及末端方向。指向於末端方向的部件可以用來插入患者 的肌膚，而指向近端方向的部件或是延長物則可以作為穿刺產品容器 之隔膜的穿織置’當注射器置人產品容H時，隔膜就會被刺穿；注 射器指向近端的部件則會與產品容器内所存放的藥品構成連接，因 此’藥品則可以藉由施加一麼力於產品容器的凸緣，而可被壓入注射 器内，並且傳遞到注射器的近端。 【發明内容】 本發明之-個目的在賊良注射器單元與注射裝置_著結合。 ⑩ 本發明的目的可轉域立項之特徵來達成，並可進_步由附屬 項、或是後續說明的實施方式、圏式來發展進一步之優點。 本發明提觀在注射裝置的注射H單元，注射^單元可以配 置在主射n或是可以藉由譬如為使用者本身的個人來分離地附著 於注射裝置。祕射單元也可·定取躲置_餅或是產品 容㈣接收容器’·在此態樣中，注射裝置可以用來重複地傳遞產品， =僅能制―次，_就衛生問題考量，建議於每次注射後都更換 新的注射器單元，而能夠降低注射感染的風險。 吁二!^=可以包含有注射器支持器，可供注射針狀，並藉由 ’ ；、末端方向突出，注射針的部件沿著末端方向突出，而可 200948406 作為注射病人支用，注射針由注射器單元朝向末端注射的長度，舉例 來說，可以設計針對皮下注射來設定長度。注射針可以藉由金屬材質 所構成，而注射器支持器則可以藉由適當的塑膠來構成，較佳者為注 射針與注射器支持器結合在一起、或是連接於注射器支持器，因而可 以在轉動、抽線方向予以固定，特別是無法釋放而脫離，一旦脫離則 會損壞，而舉例來說，注射針可以黏附在注射器支持器或是黏附在注 射器支持器環繞於注射針部份長度的地方。 一穿刺裝置可以用來刺入產品容器内，其也是由注射器單元以近 端方向突出’穿刺裝置也可以用來刺穿用來使產品容器達到密封之密 封體，其譬如為隔膜，穿刺裝置也可以藉由注射針來形成，注射針因 此可以藉由注射器支持器在長轴方向予以容納，且由注射器支持器的 兩側突出。 注射器裝置較佳者為可由注射針分離的部件，舉例來說，注射裝 置可以整合於注射器支持器，換句話說，乃是藉由注射器支持器來成 型，或是為可與注射器支持器結合在一起的分離部件，而注射器支持 器以及穿刺裝置也可以結合在一起，或是連接在一起，而無法被釋放， 換句話說，唯一釋放的方式就是加以破壞。這穿刺裝置舉例來說，可 以黏附、壓合、熔接於注射器支持器。 穿刺裝置、注射器支持器以及注射針因此構成一個單元。 注射器單元可以包含有一流體通道，特別可為一種堅固的流體通 道，藉由流體通i可將i品由產品容器運送以及/或是傳遞到病人處， 亦可提供一開口連通於流體通道之外圍環境以及流體通道’而可開啟 流體通道。當注射器單元固定到注射裝置或是產品容器時，開口亦可 以形成於產品容器的適當位置處；注射裝置包含有在近端面對側或是 近端上的開口，穿刺裝置較佳者為包含有至少一個開口，而可以側向 導通到流體通道，穿刺裝置的近端因此可以密封，以及/或是包含有可 旋轉對稱的尖端。透過穿刺裝置的開口，流體可以補充到流體通道内， 較佳者為透過注射針末端之尖端來加以分配，儘管在此描述的注射器 200948406 單元適用於傳遞產品，理論上其亦可用以移除流體，也就是流體可以 由注射器尖端進入通道，舉例來說，也可以進入產品容器，以及透過 位於流體通道且朝向於流體通道周園的開口來離開。 注射器單元也可以分別包含有數個開口，用來補充產品或是由流 體通道内擠出產品，在較佳實施例中，注射器單元包含有至少一個開 口，且導通至流體通道並連接於環境以及流體通道。注射器單元也可 包含有另外一個開口，配置在注射器上並透過流體通道而連接於上述 的開口，較佳者，流體通道並不會包含有任何開口，如此在此一方面， 就可以形成流體密封性的流體通道。 0 為使對本創作的目的、構造特徵及其功能有進一步的了解，茲配 合圖式詳細說明如下： 【實施方式】 請參閱第1〜4圖，繪示有注射器單元的一些部件形成一流體通道 6、7、8、10，其係也可視為流體導引通道。而構成流體通道6、7、8、 10之部件包含有：一延長物2、一注射器支持器彳、以及一注射針3， 延長物2亦可視為一穿刺裝置’注射器支持器，亦可視為插管支持器， 注射針3亦可視為注射管。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a syringe unit that can be combined with an injection device for medical use, particularly for infusing fluid medicines. [Prior Art] Injector devices are conventionally known. It has been widely known in the art, and in particular, it can be provided in an injection device for use by the user. For example, the European Patent No. 1 483 004 B1 discloses a syringe unit comprising a syringe and a syringe. Supporter' wherein the injector unit protrudes outwardly from both sides of the syringe holder, in other words, in the proximal direction as well as in the distal direction. The part pointing in the end direction can be used to insert the patient's skin, and the part pointing to the proximal direction or the extension can be used as the diaper of the septum product container. When the syringe is placed in the product, the diaphragm will Pierced; the proximal part of the syringe is connected to the drug stored in the product container, so the drug can be pressed into the syringe by applying a force to the flange of the product container, and Transfer to the proximal end of the syringe. SUMMARY OF THE INVENTION The object of the present invention is to combine a syringe unit with an injection device. 10 The object of the present invention can be achieved by the characteristics of the domain project, and further advantages can be developed by the sub-items, or the implementations and styles described later. The present invention is directed to the injection unit H of the injection device, which may be configured to be in the main shot n or may be separately attached to the injection device by, for example, the individual of the user himself. The secret injection unit can also be determined to hide _ cake or product capacity (four) receiving container ' In this aspect, the injection device can be used to repeatedly deliver the product, = can only be made - times, _ on the issue of health issues, It is recommended to replace the new syringe unit after each injection to reduce the risk of infection.吁二!^= may contain a syringe holder for needle injection, and protruded by ';, the end direction, the needle part protrudes along the end direction, and 200948406 can be used as an injection patient, the injection needle is The length of the syringe unit injected towards the end, for example, can be designed to set the length for subcutaneous injection. The injection needle can be made of a metal material, and the syringe holder can be formed by a suitable plastic, preferably the injection needle is combined with the syringe holder or connected to the syringe holder, so that it can be rotated The direction of the drawing is fixed, in particular, it cannot be released and detached. If it is detached, it will be damaged. For example, the needle can be adhered to the syringe holder or adhered to the syringe holder around the length of the needle. A puncture device can be used to penetrate into the product container, which is also protruded from the syringe unit in the proximal direction. The puncture device can also be used to pierce the sealing body used to seal the product container, such as a diaphragm and a puncture device. It can be formed by an injection needle which can thus be accommodated in the long axis direction by the syringe holder and protruded from both sides of the syringe holder. The injector device is preferably a component that can be separated by an injection needle. For example, the injection device can be integrated into the syringe holder, in other words, by a syringe holder, or can be combined with a syringe holder. The separate components are separated, and the syringe holder and the lancing device can be combined or connected together and cannot be released. In other words, the only way to release is to destroy. For example, the lancing device can be adhered, pressed, and welded to the syringe holder. The lancing device, the syringe holder and the injection needle thus constitute a unit. The injector unit may comprise a fluid passage, in particular a solid fluid passage through which the fluid can be transported from the product container and/or delivered to the patient, or an opening connected to the periphery of the fluid passage. The environment as well as the fluid channel' opens the fluid channel. The opening may also be formed at a suitable location on the product container when the syringe unit is secured to the injection device or product container; the injection device includes an opening on the opposite side or proximal end of the proximal end face, preferably the piercing device comprises There is at least one opening that can be guided laterally to the fluid passage, the proximal end of the piercing device can thus be sealed, and/or contain a rotationally symmetrical tip. Through the opening of the lancing device, fluid can be replenished into the fluid channel, preferably through the tip of the end of the needle, although the injector 200948406 unit described herein is suitable for delivering products, which in theory can also be used to remove fluids. That is, fluid can enter the channel from the tip of the syringe, for example, also into the product container, and exit through an opening in the fluid channel that faces the circumference of the fluid channel. The injector unit may also include a plurality of openings for supplementing the product or for extruding the product from the fluid passage. In a preferred embodiment, the injector unit includes at least one opening and is coupled to the fluid passage and to the environment and fluid. aisle. The injector unit may also include another opening disposed on the syringe and coupled to the opening through the fluid passage. Preferably, the fluid passage does not include any opening, so that a fluid seal may be formed on the one hand. Sexual fluid passages. 0 In order to further understand the purpose, structural features and functions of the present creation, the following is a detailed description of the following: [Embodiment] Referring to Figures 1 to 4, some components of the injector unit are formed to form a fluid passage. 6, 7, 8, 10, which can also be regarded as a fluid guiding channel. The components constituting the fluid passages 6, 7, 8, 10 include: an extension 2, a syringe holder 彳, and an injection needle 3, and the extension 2 can also be regarded as a puncturing device 'syringe holder, or can be regarded as The cannula holder, the injection needle 3 can also be regarded as a syringe.
中空環狀的注射針3較佳者為具有固定的外徑D3、以及固定的 内徑。於末端上，係具有切開的尖端而形成非對稱的截面顯示，注射 針3用以插人患者的皮膚内，並在近端藉由注射器支持器彳來加以固 定在此所纷示的固定方式包含將注射針3的一部分容納於圓柱中空 的鑽孔5内’而鑽孔5的内徑概略對應約主射針3的外徑，譬如當注 射器支持器1是個射出成型時’注射針3原則上可以用壓二或是塑 器支抑1之圓柱巾娜卩位，較佳者為帥針3黏附於注 2器，器1上。為了避免當橫向力施加於注射針3時使應力達到峰 祕的部份連接至—個擴張區域，如圖中轉示，特別是此區 域擴張為類似軌絲延伸至注射器支持器彳的末端4外，此區域 200948406 亦可用來容置黏著劑，而可黏接注射器支持器彳以及注射針3。較佳 者，注射針3固定於注射器支持器1而無法脫離，注射針3藉由金屬 材質構成而更適合用來注射用，而注射器支持器i則藉由塑膠材質構 成。 注射器支持器1包含有流體通道部份8，用以連接在注射針3的 近端’較佳者，此部份可設計為圓柱中空狀，特別的是，此部份8概 略具有與注射針3相同的流體導引截面，尤其是具有相同的内徑如 此的配置，可以有效降低當流體由此部份8傳送到注射針3之部份 1〇，所可能產生紊流或是擾流的風險》 ° 注射器支持器1也包含有流艎導引通道部份7，且其具有比流親 通道部份8、10果大的流髏導引截面積，流體導引通道部份7沿著注 射針3的方向形成錐狀，換句話說，流體導引通道部份7之流體導引 截面積，在朝向注射針3的方向上遞減。舉例來說，流體導引截面積 γ以相同的比率來遞減，換句話說，就是固定的梯度變化，如囷中所 示，可用遞增與/或遞減的梯度來變化。在注射針3的方向上，流體導 引截面積初始在遞增的梯度下減少，接著流艘導引截面積在遞減的梯 度下形成錐狀。在長軸斷面，流體通道的流體導引通道部份7呈現通 道側壁之凹曲©與/或凸曲面’在注杖針3的方向，流丨通道部份 7的側壁初始呈現凹曲面，然後在轉為凸曲面。而兩個別部份之間的 轉折，舉例來說，就是凹曲面與凸曲面之間的轉折，可以是連績或至 少沒有銳利的邊緣，同理，流趙導引通道部份7至流體導引通道部份 8之間的轉折也是可相同適用。 注射器支持器1包含有-轴’舉例來說為圓柱狀轴，而由末端延 伸並可供注射針3來設置與固定。 注射器支持肖1藉由結合祕裝置9錢接祕錄2，此結合 連接裝置9可以是彻緊迫、材料或是對位方式來結合連接，特別的 疋，結合連接裝置9係為防水，同時，此結合連接裝置9尤其可以藉 由黏接、壓應力、拴鎖、或熔接等方式來達成。 200948406 連接於注射器支持器1的延長物2包含有一流體導引通道6、7、 8、10的一個流體導引通道部分6，此流體導引通道部份6沿著注射 針3的方向擴大，譬如可以呈現漏斗或是圓錐形，舉例來說，此擴大 的角度概略具有圓錐形的4。斜角，當然，此圓雜形斜角可以由<|。〜 45° ’但以較小的圓錐角度為佳。 較佳者，當注射器支持器1連接於延長物2時，流體導引通道部 份6會導通於流體導引通道部份7，流體導引通道部份6與流體導引 通道部份7可以分別具有相同的流體導引截面積，特別是在開孔處具 有相同的内徑。 ❿ 舉例來說’流體導引通道部份6可以具有最大流體導引截面積以 及最小流體導引截面積的截面積比率為4: 1，而截面積比率在2:1 到10 ·彳之間的優點是獲得證實的，此一比率也可以是2.5 : 1。 流體的提供，乃是由延長物2的環境透過開口 4而至流體導引通 道6、7、8、10來加以補充，儘管理論上一個開口 4已經足夠，但是 舉例來說提供兩個開口 4將會有更大的優勢，因為其可安排設至於彼 此相對地位於流體導引通道6的兩側，因此，流體導引通道6的一部 分配置於開口 4之間。舉例來說，開口 4可以是長孔狀，長度大約在 於1〜4釐米（mrrr)，譬如可為3釐米，而其寬度可大約等同於流艟 〇 導引通道6位於開孔4之間部份的半徑，開口 4整體的截面區域較佳 者可以大於流體導引通道部份6之流體導引橫截面的最小值。假使單 一開口 4的截面積較大已經具備有相當多優點，開口 4的整體截面積 區域與流體導引通道部份6的流體導引截面積的比率可例如為7:，， 開口 4的整體橫剖面區域應該要至少等同於流體導引截面積的最小 值，此一橫截面比率可譬如為2 : 1〜10 : 1之間。 在此一實施例中，延長物2包含有轉動對稱的尖端，其可譬如為 圓錐狀並形成於延長物2之末端，兩個開口 4的配置可以使得流艘由 橫向補充，換句話說’橫向於長轴，接著在流體導引通道6、7、8、 10内往注射針3的方向沿著其長軸傳遞。 200948406 延長物2包含有一連接部12，用以直接或是間接地將連接在一起 的注射器支持器1、延長物2以及注射針3,連接到注射裝置的一部分， 另一方面，注射器支持器1也可以包含此連接部12» 在流髏通道7的區域内，注射器支持器1的近端包含有一凹槽， 其乃藉由圓弧狀突出物圍繞，在此一範例中，圓弧狀突出物係同心於 注射器單元100之長軸’延長物2的末端具有概略對應注射器支持器 1之近端面對侧的負模（negative mould)形狀，特別的是，延長物2 的近端面對側包含有圓弧狀溝槽，當延長物2與注射器支持器1結合 在一起時，可供圃旅狀突出物置入結合，且更包含截短的圓錐形突出 物’而可於當延長物2與注射器支持器1結合在一起時，噛合於注射 器支持器1的凹槽；如此可已達到結合連接裝置9也具有防水的優點， 而兩個面對側的嚙合，也增加了結合連接裝置9可以使用的面積。 注射針3可以選擇較廣範圍的半徑、壁厚、長度，舉例來說，其 可以提供23規格針（23 gauge needle)或是31規格針（31 gauge needle)。注射針3的注射長度也可以設計皮下（subcutaneous)注 射或是經皮（transcutaneous)注射。 完整的注射器單元1〇〇繪示於第5、6囷，注射器單元1〇〇包含 有注射器支持器1、延長物2、以及藉由連接部12連接於一固定部，3 的注射針3。套筒狀的固定部13用以連接於固定件20，根據此一目 的可包含有一螺紋，特別是外螺紋，由注射器單元100形成的流體通 道6、7、8、10轴向固定地連接到固定部13，根據其應用，注射器支 持器1、延長物2以及注射針3相對於固定部13可以轉動、或不可轉 動，注射器支持器1、延長物2以及注射針3包含有連接突出物12a， 而可噃合於形成於固定部13之内周緣的圓弧狀溝槽13c，固定部13 較佳者為連接到外軍14 ,因此，其轉動、轴向方向接受到固定，理論 上固定部13舆外單14也可以-艘成形，然而，予以分開為數個部 件將有利於製造注射器單套筒狀的外罩14於周圍侧環繞於固 定部13以及延長物2及其尖端，外罩14沿著近端方向延伸，如圖中 200948406 所示’至少達到尖端的部位或是超出尖端，如此一來，延長物2的尖 端就不會突出外罩14的近端。藉此外罩14突出於延長物2的尖端， 使得由延長物2尖端刺穿的風險可以降低。於固定部a與外軍14之 間形成有圓弧狀間隙，外罩14、固定部13、以及注射器支持器，、延 長物2與注射針3係彼此相對同心地配置》 外罩14的近端包含有-面對區域，其包含有一開口，藉由特殊的 長度突出注射針3，此長度大致上對應於注射針3的注射深度，因為 外罩14 6¾近端與病人身體之間$成鄰接區域，基於間隔的理由，外單 14可以包含有容置注射器支持器1的孔穴。 注射器單元1G也包含有包裝套筒15，如第5、6圖所示，係配置 於與外罩15之周緣同心的位置，包裝套筒15較佳者是藉由外罩14 =支撑，制是利用摩擦力的方式。包裝套筒15較佳者完整環繞於 外軍14之周緣，並且超ώ其長度，較佳者，包裝套筒$之近端至少 =突出於外罩14的近端，包裝套筒15之近端所形成的開口可供 =二注射器支持器]、延長物2以及注射針3 —起置人或是移除， 二台奘運送注射器單^ 1〇0時可以藉由包裝膜來加以密封 ，以維 ❹ :容物的料絲（Sterile)歧至少純保護防止 =。包餘筒15末端如於注射針3的末端，而可在其面對側加以 密封，就此一方面，包裝套筒15形成有封閉 力包裝套筒15的外周緣包含有可供使用者可輕易施 震裝套筒15的結構’因為當完整置放於外罩I4時，包 =心是以摩擦力的方式連接至外罩14並無法相對轉動當然， 包的方式連接固定，因此，當施加扭力於 同=時，餅料14侧定部13會伴隨著包裝套筒15 - ^ ( ^ 1〇 1) * 各自與安：。=:第(= 、第5 6圖並一同組合於第7圖，而組合 200948406 於一注射器單元100則繪示於第8囷》 如同第5、6圖所緣示的安瓶40稱之為雙腔艘安瓶（two-chamber ampoule) ’亦可參見於雙腔體卡瓿（two-chambercarpoule)，其特性 為產品可以在提供前，可將存放於兩個不同腔體内的物品予以直接混 合。末端的腔體，換句話說，配置在密封體41、42、43、44以及第 一凸緣45之間的腔體，可以被部份或是完全地充填譬如為粒狀、或是 粉末狀的材料。第二腔體位於相對第一凸緣45之近端，並且配至於第 一凸緣45與第二凸緣46之間，構成藥品的流體可以被設置在此一腔 體，兩凸緣45、46皆抵靠於安瓿40之圓柱狀令空的外罩部48,而形 成密封狀態，並可沿著外單部48位移。 在外罩部48的區域内，安瓿40包含有形成於腔體外部的旁路 47 ’旁路47在轴向上長過第一凸緣45。 為了混合，施加壓力於第二凸緣46的近端方向，並透過位於第一 凸緣45以及第二凸緣46之間的腔體内之流體產品傳遞至第一凸緣 45，當第二凸緣46朝向近端方向位移，第一凸緣46也會因此跟著位 移，如同旁路47區域的長度《由於旁路47的腔體，因此可提供第一 凸緣45使其完整位於旁路47的區域内，進而使流體產品可以流經第 一凸緣45進入末端腔教，而可與位於此處的產品成份混合〇使用者也 可以藉由搖晃裝置來輔助混合，當第二凸緣46抵靠於第一凸緣45時， 流體產品則被完整的由近端腔體移除，包含兩種產品成份的混合物可 以形成均質性（homogeneous)或是異質性（heterogeneous)的混 合物’具有固態顆粒的流體成份之異種混合物一般可視為分散、或是 懸浮物。接著要被提供的產品藉由第一凸緣45、第二凸緣46沿著圓 柱形中空外罩部48之遠端方向的位移，並透過注射器單元1〇〇之流 艘通道6、7、8、10、位於安瓶40内的開口 4，而傳遞至譬如為區域 42。 安瓶40包含有密封體41、42、43、44，且其包含有一可供延長 物2穿透的隔膜（明ptum) 41，如此的隔片（septa)可以藉由橡勝、 200948406 天然橡膠、或是其他適合的人造材料所構成β 隔膜41包含有碟片狀部位、以及連接於近端方向的圓柱狀中空部 份，圓柱狀中空部位在其内部形成一孔穴，在此一實施例中，完整附 著的注射器單元100之開口 4與此孔穴相對，隔膜41的圓柱狀中空 部位之外側，放置於在安瓿40之内緣之隔膜41，特別是在安瓿40的 末端上。圓孤狀周園的凸塊形成於安瓶4〇的末端，並且徑向朝外突出 而可視為一凸出物，凸塊43徑向突出並超出安瓿4〇的圓柱狀中空部 位48之外緣’換句話說，在凸塊43的點上，安瓶4〇具有比圓柱狀 中空部位48區域更大的外徑。舉例來說，凸塊43的外徑也可以形成 ® 安银4〇的最大外徑。凸塊43整合連接於圓柱狀中空部位48，安银 40的此一部份可以利用塑膠、或是玻璃製作，隔膜41的碟片狀部件 概略具有與凸塊43相同的外徑，隔膜41與凸塊43藉由更新部.44共 同固定，其可利用譬如為金屬板件來製作，此部件亦可是為帽體。更 新部44以橫跨相對於隔膜41之末端以及相對於凸塊4彳之近端的方 式來扣住隔膜41以及凸塊43,因為更新部44連接於凸塊43以及隔 膜41，因此於軸向方向被限制固定，換句話說，於流體密封上固定在 一起。更新部44之末端面對側包含有一譬如為圓形之開口，藉此，延 ❹長物2可以插入隔琪41而連入已經混合好之安瓶4〇的内部。 在圈柱狀中空部位48以及凸塊43之間，安瓶40包含一個頸部， 其受到相對於圓柱狀中空部位48的外徑所壓縮，如此一來，更新部 44可以被重新模造地更佳，特別是在於環繞凸塊43的近端側。安瓿 40的近端側係為開放式’因此，活塞桿（p|unger ro^) 52 (見第1〇 圖）可以滑入安瓿40並位於第二凸緣46。 固定件20可以固定於安瓶容器30，固定件2〇以及安瓶容器3〇 較佳者可是為安瓶承載座，固定件20係為套筒狀，且連接至安瓶容器 30，較佳者為以拴鎖方式連接，如此一來就將轉動方向、與軸方向予 以固定，轉動方向的固定較佳者可以藉由孔穴23以及凸輪34之間的 嚙合來達成，固定件20在安瓿容器30之軸方向的固定配置則可藉由 200948406 凸輪32拴鎖至窗口 22來達成。 請參閱第5、6圖，安瓿40透過套筒狀安瓿容器30末端開口而 插入安瓶容器内，密封體41、42、43、44之外徑大於安瓶容器30之 内徑，因此密封體41、42、43、44會緊鄰於安瓿容器30的末端•如 第7圖所示，安瓿40的密封體以軸向圍繞於安瓿容器30以及固定件 20之間’而使得轴方向固定，在此一實施範例中，亦可允許安瓿40 具有微小的軸向間隙，較佳者為盡量予以靠進來降低此一轴向間隊。 最後’安瓿容器30的末端具有至少一個突出物，在此一實施態樣，為 具有四個突出物35,其係由末端方向延伸，並緊鄰於密封體41、42、 43、44，此至少一個突出物35可以堅固地配置在安瓿承載座，特別 〇 是在安瓿容器30上’如圖中所繪示的位置、或是藉由彈力拉緊的狀 態，如此藉由彈力拉緊狀態將可提供更進一步的優點，來使的轴向間 隙幾乎不再存在，此彈力拉緊的配置可以藉由提供一裂缝來達成，此 裂縫沿著周圍方向延伸，並相對於至少一個突出物35的近側，如此一 來，位於裂缝以及突出物35之間就會具有轴方向的彈力。 密封體41、42、43、44可以藉由形成於固定件2〇之内緣的轴環 而靠近於末端侧’軸環可以部份或是全部環繞於周圍。突出物28由内 緣區域向内延伸，並可選擇性地與軸環一同作為密封體41、42、43、 44的圍攔，在指向密封艘41、42、43、44的一侧，突出物28包含 〇 一個特別是凸輪27的突出物，壓迫抵靠於密封體之末端面對區域，尤 其是抵靠於更新部44。密封體的一部分，譬如為更新部44，可以藉由 凸輪27的單點聚焦負擔而彈性或是塑膠變形，藉此而可在使密封體 41、42、43、44在安瓿容器30與固定件20之間達到牢固、低間隙 的靠緊；而凸輪27可以穩固地配置或是於長軸方向彈力拉緊。 如第5〜7圈所示，安瓶容器30的外緣包含有外螺紋33，藉此， 安瓿承載座可以螺旋鎖固於注射器裝置50的外罩51 (見第1〇圖）， 其中外罩51包含有一對應的内螺紋，而可配合安瓿承載座的外螺紋 33。為了提供使用者更便利的直覺性操作此裝置50，安瓿承載座2〇、 12 200948406 30上至少配置有一個箭頭，特別是在安瓶容器3〇的外緣上如此一 來可以只是旋轉的方向來混合此裝置，較佳者，-堆箭頭分佈於整個 安额容器30的長度上，箭頭亦可為貼印方式，或是於安瓶容器邠射 出成型時’隆起、凹陷來模造成^{，而至少—個的箭頭可以配置在外 螺紋33的一段導程之間。 安瓿承載座，特別指安瓿容器30，也包含拴鎖元件36，而於徑向 方向彈力拉緊蚊，藉由-臂強於周緣方向延伸而產生彈力，且其形 成在女瓶容器30上，也就是拴鎖元件％形成的地方，此一拾鎖元件 36的功能，特別指一凸輪，可參閲下面配合第1〇圖之描述。The hollow annular injection needle 3 preferably has a fixed outer diameter D3 and a fixed inner diameter. On the end, there is a cut-off tip to form an asymmetrical cross-sectional display, the injection needle 3 is inserted into the skin of the patient, and is fixed at the proximal end by a syringe holder 在 in the fixed manner Included that a portion of the injection needle 3 is received in the hollow bore 5 of the cylinder' and the inner diameter of the bore 5 roughly corresponds to the outer diameter of the main needle 3, such as when the syringe holder 1 is injection molded. On the top of the cylinder can be used to press the second or the plastic tube to support 1 cylindrical towel, preferably the handsome needle 3 adheres to the injection device 2, device 1. In order to avoid connecting the portion where the stress reaches the peak when the lateral force is applied to the injection needle 3, the portion is connected to the expansion region, as shown in the figure, in particular, the region is expanded to resemble the extension of the wire to the end of the syringe holder 4 4 In addition, this area 200948406 can also be used to hold the adhesive, but can be attached to the syringe holder 彳 and the injection needle 3. Preferably, the injection needle 3 is fixed to the syringe holder 1 and cannot be detached. The injection needle 3 is made of a metal material and is more suitable for injection, and the syringe holder i is made of a plastic material. The syringe holder 1 includes a fluid passage portion 8 for attachment to the proximal end of the injection needle 3. 'This portion can be designed to be hollow in a cylindrical shape. In particular, the portion 8 has a needle and a needle. 3 The same fluid guiding section, especially with the same inner diameter, can effectively reduce the turbulence or turbulence that may occur when the fluid is transferred from the portion 8 to the injection needle 3. Risks ° ° The syringe holder 1 also includes a rogue guiding channel portion 7 which has a larger flow guiding cross-sectional area than the flow-receiving channel portions 8, 10, and the fluid guiding channel portion 7 follows The direction of the injection needle 3 is tapered, in other words, the fluid guiding cross-sectional area of the fluid guiding passage portion 7 is decreased in the direction toward the injection needle 3. For example, the fluid guiding cross-sectional area y is decremented by the same ratio, in other words, a fixed gradient change, as shown in 囷, which can be varied by increasing and/or decreasing gradients. In the direction of the injection needle 3, the fluid guide cross-sectional area is initially reduced by an increasing gradient, and then the flow guide cross-sectional area is tapered at a decreasing gradient. In the long-axis section, the fluid guiding channel portion 7 of the fluid channel presents a concave curve of the channel side wall and/or a convex curved surface in the direction of the needle 3, and the side wall of the flowing channel portion 7 initially presents a concave curved surface. Then turn to a convex surface. The transition between the two parts, for example, is the transition between the concave surface and the convex surface, which can be a continuous performance or at least no sharp edges. Similarly, the flow guide channel portion 7 to the fluid The transition between the guide channel portions 8 is equally applicable. The syringe holder 1 includes a --axis ', for example, a cylindrical shaft, and is extended by the end and is provided for fixation by the injection needle 3. The syringe support Xiao 1 is connected to the secret record 2 by combining the secret device 9 , and the joint connection device 9 can be a tight pressing, material or alignment manner to connect the joints, and the joint joint device 9 is waterproof. This bonding device 9 can be achieved in particular by means of bonding, compressive stress, shackle, or welding. 200948406 The extension 2 attached to the syringe holder 1 comprises a fluid guiding channel portion 6 of a fluid guiding channel 6, 7, 8, 10 which expands in the direction of the needle 3, For example, a funnel or a conical shape can be presented, for example, this enlarged angle has a conical shape 4 . Bevel, of course, this rounded bevel can be made by <|. ~ 45° ' but better with a smaller cone angle. Preferably, when the syringe holder 1 is connected to the extension 2, the fluid guiding channel portion 6 is electrically connected to the fluid guiding channel portion 7, and the fluid guiding channel portion 6 and the fluid guiding channel portion 7 can be They each have the same fluid guiding cross-sectional area, in particular having the same inner diameter at the opening. ❿ For example, 'the fluid guiding channel portion 6 can have a maximum fluid guiding cross-sectional area and a minimum fluid guiding cross-sectional area ratio of 4:1, and the cross-sectional area ratio is between 2:1 and 10·彳. The advantage is that it is confirmed, this ratio can also be 2.5:1. The supply of fluid is supplemented by the environment of the extension 2 through the opening 4 to the fluid guiding channels 6, 7, 8, 10, although theoretically an opening 4 is sufficient, for example, two openings 4 are provided. There will be a greater advantage because it can be arranged to be situated opposite each other on both sides of the fluid guiding channel 6, so that a part of the fluid guiding channel 6 is arranged between the openings 4. For example, the opening 4 may be elongated, having a length of about 1 to 4 centimeters (mrrr), for example, 3 centimeters, and a width of about the same as the flow guiding channel 6 between the openings 4. The radius of the portion, the overall cross-sectional area of the opening 4 may preferably be greater than the minimum of the fluid guiding cross-section of the fluid guiding channel portion 6. If the cross-sectional area of the single opening 4 is large, there is considerable advantage that the ratio of the overall cross-sectional area of the opening 4 to the fluid guiding cross-sectional area of the fluid guiding channel portion 6 can be, for example, 7:, the entirety of the opening 4. The cross-sectional area should be at least equal to the minimum of the fluid guiding cross-sectional area, which may be, for example, between 2:1 and 10:1. In this embodiment, the extension 2 comprises a rotationally symmetrical tip which can be, for example, conical and formed at the end of the extension 2, the two openings 4 being arranged such that the flow boat is replenished laterally, in other words ' Transverse to the long axis, then in the direction of the injection needle 3 in the fluid guiding channels 6, 7, 8, 10 along its long axis. 200948406 The extension 2 comprises a connecting portion 12 for directly or indirectly connecting the syringe holder 1, the extension 2 and the injection needle 3 connected together to a part of the injection device, and on the other hand, the syringe holder 1 The connection portion 12» can also be included. In the region of the sputum channel 7, the proximal end of the syringe holder 1 comprises a recess which is surrounded by an arcuate projection, in this example an arcuate projection The end of the long axis 'extension 2 of the injector unit 100 concentric with the syringe unit 100 has a negative mould shape that roughly corresponds to the opposite side of the proximal end of the syringe holder 1 , in particular, the proximal end pair of the extension 2 The side comprises a circular arc-shaped groove, when the extension 2 is combined with the syringe holder 1, the truss-like protrusion can be placed in the joint, and the truncated conical protrusion is further included, and the extension can be used as the extension 2 when combined with the syringe holder 1, it fits into the groove of the syringe holder 1; thus, it can be achieved that the joint connection device 9 also has the advantage of waterproofing, and the engagement of the two facing sides also increases the joint connection. 9 can be used in the area. The injection needle 3 can select a wide range of radii, wall thickness, length, for example, it can provide a 23 gauge needle or a 31 gauge needle. The injection length of the injection needle 3 can also be designed for subcutaneous injection or transcutaneous injection. The complete syringe unit 1 is shown in Figs. 5 and 6 and the syringe unit 1 includes a syringe holder 1, an extension 2, and an injection needle 3 connected to a fixed portion 3 by a connecting portion 12. The sleeve-like fixing portion 13 is for connecting to the fixing member 20, and according to this purpose, a thread, in particular an external thread, may be included, and the fluid passages 6, 7, 8, 10 formed by the injector unit 100 are axially fixedly connected to The fixing portion 13 according to the application thereof, the syringe holder 1, the extension 2 and the injection needle 3 are rotatable or non-rotatable with respect to the fixing portion 13, and the syringe holder 1, the extension 2 and the injection needle 3 include the connection protrusion 12a The arcuate groove 13c formed on the inner periphery of the fixing portion 13 is preferably coupled to the outer army 14, so that the rotation and the axial direction are fixed, and theoretically fixed. The outer portion 14 can also be formed, however, the division into a plurality of components will facilitate the manufacture of the syringe single sleeve-like outer cover 14 around the fixed portion 13 and the extension 2 and its tip on the peripheral side, the outer cover 14 Extending in the proximal direction, as shown in 200948406, 'at least the tip end portion or beyond the tip end, so that the tip end of the extension 2 does not protrude from the proximal end of the outer cover 14. Thereby the outer cover 14 protrudes from the tip end of the extension 2, so that the risk of piercing by the tip of the extension 2 can be reduced. An arcuate gap is formed between the fixed portion a and the outer army 14, and the outer cover 14, the fixed portion 13, and the syringe holder are disposed, and the extension 2 and the injection needle 3 are arranged concentrically with each other. The proximal end of the outer cover 14 includes a face-facing area comprising an opening, the needle 3 being protruded by a special length, the length substantially corresponding to the depth of injection of the needle 3, since the proximal end of the outer cover 14 63⁄4 is adjacent to the patient's body, The outer sheet 14 may contain holes for housing the syringe holder 1 for reasons of spacing. The syringe unit 1G also includes a packaging sleeve 15, which is disposed at a position concentric with the periphery of the outer cover 15 as shown in Figs. 5 and 6, and the package sleeve 15 is preferably supported by the outer cover 14 = The way of friction. Preferably, the packaging sleeve 15 is completely wrapped around the periphery of the outer army 14 and exceeds its length. Preferably, the proximal end of the packaging sleeve $ at least = protrudes from the proximal end of the outer cover 14, the proximal end of the packaging sleeve 15. The formed opening can be used for the two syringe holders, the extensions 2 and the injection needles 3 to be placed or removed, and the two magazines can be sealed by the packaging film when transporting the syringes 1 to 0. Wei Wei: The material of the Sterile is at least purely protected against. The end of the bag 15 is at the end of the injection needle 3, but can be sealed on the facing side thereof. On the one hand, the outer circumference of the packaging sleeve 15 formed with the sealing force packaging sleeve 15 is easily accessible to the user. The structure of the shock-shielding sleeve 15 is because when the cover is completely placed on the outer cover I4, the bag is connected to the outer cover 14 in a frictional manner and cannot be relatively rotated. Of course, the package is fixedly connected, and therefore, when a torque is applied When the same =, the side portion 13 of the cake 14 is accompanied by the packaging sleeve 15 - ^ ( ^ 1 〇 1) * each with an:. =: (=, Fig. 6 and together in Fig. 7, and combination 200948406 in a syringe unit 100 is shown in Fig. 8) As shown in Figs. 5 and 6, Ampoule 40 is called The two-chamber ampoule can also be found in the two-chambercarpoule, which is characterized by the fact that the product can be directly stored in two different chambers before being supplied. Mixing. The cavity at the end, in other words, the cavity disposed between the sealing bodies 41, 42, 43, 44 and the first flange 45, may be partially or completely filled, for example, granular, or a powdered material. The second cavity is located at a proximal end opposite the first flange 45 and is disposed between the first flange 45 and the second flange 46, and a fluid constituting the medicine can be disposed in the cavity. Both flanges 45, 46 abut against the cylindrical outer cover portion 48 of the ampoule 40 to form a sealed condition and are displaceable along the outer unit 48. In the region of the outer cover portion 48, the ampoule 40 is formed The bypass 47' bypass 47 outside the cavity grows axially past the first flange 45. For mixing, pressure is applied The proximal end of the second flange 46 is transmitted to the first flange 45 through the fluid product in the cavity between the first flange 45 and the second flange 46, with the second flange 46 facing the proximal end In the directional displacement, the first flange 46 is thus also displaced, as is the length of the bypass 47 region. Due to the cavity of the bypass 47, the first flange 45 can be provided to be completely within the region of the bypass 47, thereby The fluid product can flow through the first flange 45 into the end cavity and can be mixed with the product components located therein, and the user can also assist the mixing by the shaking device when the second flange 46 abuts the first At the flange 45, the fluid product is completely removed from the proximal cavity, and a mixture comprising the two product components can form a homogeneous or heterogeneous mixture of fluid components having solid particles. The heterogeneous mixture is generally considered to be dispersed or suspended. The product to be supplied is then displaced by the first flange 45, the second flange 46 along the distal end of the cylindrical hollow outer casing portion 48, and through the injector unit. 1 stream The passages 6, 7, 8, 10 are located in the opening 4 in the ampoules 40 and are transferred to, for example, the area 42. The ampoules 40 contain seals 41, 42, 43, 44 and include an extender 2 penetrating membrane (bump) 41, such a septum can be composed of rubber, 200948406 natural rubber, or other suitable man-made materials. The membrane 41 contains a disc-like portion and is connected to The cylindrical hollow portion in the proximal direction forms a hole in the cylindrical hollow portion. In this embodiment, the opening 4 of the completely attached syringe unit 100 is opposed to the hole, and the cylindrical hollow portion of the diaphragm 41 is On the outside, a septum 41 is placed on the inner edge of the ampoule 40, particularly at the end of the ampoule 40. The convex shape of the circular orbit is formed at the end of the ampule 4, and protrudes radially outward to be regarded as a projection, and the projection 43 protrudes radially beyond the cylindrical hollow portion 48 of the ampoule 4〇. In other words, at the point of the bump 43, the ampule 4 has a larger outer diameter than the area of the cylindrical hollow portion 48. For example, the outer diameter of the bumps 43 can also form a maximum outer diameter of ® 银 4 。. The bump 43 is integrally connected to the cylindrical hollow portion 48. The portion of the silver 40 can be made of plastic or glass. The disc member of the diaphragm 41 has the same outer diameter as the bump 43 and the diaphragm 41 and The bumps 43 are fixed together by the updating portion 44, which can be fabricated, for example, as a metal plate member, which may also be a cap. The updating portion 44 fastens the diaphragm 41 and the bump 43 so as to straddle the end of the diaphragm 41 and the proximal end of the bump 4, since the updating portion 44 is connected to the bump 43 and the diaphragm 41, so the shaft The direction of orientation is fixed, in other words, fixed together on the fluid seal. The end facing side of the updating portion 44 includes an opening such as a circular shape, whereby the elongated object 2 can be inserted into the compartment 41 and connected to the inside of the already-mixed ampule. Between the cylindrical hollow portion 48 and the projection 43, the ampoule 40 includes a neck that is compressed relative to the outer diameter of the cylindrical hollow portion 48, so that the renewal portion 44 can be remolded more Preferably, it is in particular to surround the proximal side of the bump 43. The proximal side of the ampoule 40 is open. Thus, the piston rod (p|unger ro^) 52 (see Fig. 1) can be slid into the ampoule 40 and located at the second flange 46. The fixing member 20 can be fixed to the ampoules container 30, the fixing member 2〇 and the ampoules container 3. Preferably, the fixing member 20 is an ampoules, and the fixing member 20 is sleeve-shaped and connected to the ampoules 30, preferably. In order to connect in a shackle manner, the direction of rotation and the direction of the axis are fixed. The fixing of the direction of rotation can preferably be achieved by the engagement between the hole 23 and the cam 34. The fixing member 20 is in the ampoules container. The fixed configuration of the 30-axis direction can be achieved by the 200948406 cam 32 being locked to the window 22. Referring to Figures 5 and 6, the ampoule 40 is inserted into the ampoules through the end opening of the sleeve-like ampoule container 30. The outer diameter of the sealing bodies 41, 42, 43, 44 is larger than the inner diameter of the ampoules 30, so the sealing body 41, 42, 43, 44 will be immediately adjacent to the end of the ampoule container 30. As shown in Fig. 7, the sealing body of the ampoule 40 is axially surrounded between the ampoule container 30 and the fixing member 20 to fix the axial direction. In this embodiment, the ampoule 40 can also be allowed to have a slight axial clearance, and it is preferable to reduce it as much as possible to reduce the axial inter-team. Finally, the end of the ampoule container 30 has at least one protrusion. In this embodiment, there are four protrusions 35 extending from the end direction and adjacent to the sealing bodies 41, 42, 43, 44, which are at least A protrusion 35 can be firmly disposed in the ampoule carrier, in particular, in the position of the ampoule container 30 as shown in the figure, or in a state of being tensioned by elastic force, so that the state can be tensioned by the elastic force. Providing a further advantage that the axial gap is almost no longer present, the elastic tensioning arrangement can be achieved by providing a crack that extends in the peripheral direction and is adjacent to the at least one protrusion 35 On the side, in this way, there is an elastic force in the axial direction between the crack and the protrusion 35. The sealing bodies 41, 42, 43, 44 may be partially or completely surrounded by the collar which is formed on the inner edge of the fixing member 2b and close to the end side. The projection 28 extends inwardly from the inner edge region and is selectively engageable with the collar as a barrier for the sealing bodies 41, 42, 43, 44, projecting on the side directed toward the sealing boat 41, 42, 43, 44 The article 28 comprises a projection of a cam, in particular a cam 27, which is pressed against the end facing area of the sealing body, in particular against the renewal portion 44. A part of the sealing body, such as the updating portion 44, can be elastically or plastically deformed by the single point focusing load of the cam 27, whereby the sealing body 41, 42, 43, 44 can be placed in the ampoule container 30 and the fixing member. A firm, low-gap abutment is achieved between the 20; and the cam 27 can be configured securely or elastically in the direction of the long axis. As shown in the fifth to seventh laps, the outer edge of the ampoules container 30 includes external threads 33, whereby the ampoule carrier can be screwed to the outer cover 51 of the injector device 50 (see Fig. 1), wherein the outer cover 51 A corresponding internal thread is included to fit the external thread 33 of the ampoule carrier. In order to provide a more convenient intuitive operation of the device 50, the ampoule carrier 2, 12 200948406 30 is provided with at least one arrow, in particular on the outer edge of the ampoules 3 如此 so that it can only be rotated. To mix the device, preferably, the stack arrow is distributed over the length of the entire forehead container 30, and the arrow can also be printed, or when the ampoules are ejected and molded, the ridges and depressions are formed. And at least one of the arrows may be disposed between a lead of the external thread 33. The ampoule carrier, in particular the ampoule container 30, also includes the shackle element 36, and elastically pulls the mosquito in a radial direction, and the elastic force is generated by the arm extending stronger than the circumferential direction, and is formed on the bottle container 30, That is, where the shackle element % is formed, the function of the shackle element 36, particularly a cam, can be referred to the following description in conjunction with FIG.
固定件20也包含有單-導程或是多數導程的端纹，在此一實施例 中，以兩個螺紋部21的型態來使注射器單元1〇〇致能，此螺紋包含 有外於固定部' 13的外螺紋，而可鎖固於注射裝置上。當注射器單元 100螺旋轉動時，由於延長物2的軸向運動，延長物2的尖端會刺入 隔膜41内，螺旋轉動注射器單元100所需的扭力可藉由包裝套筒15 或是外罩14來加以施加，一旦注射器單元1〇〇已經完全螺旋轉動到 底’其位置可以如第8囷之態樣，在此一實施例中，開口位於安瓶4〇 内’如此一來注射針3的末端流體連接於安瓿4〇内部，固定件2〇的 末端部位接著處於位在固定部13以及外罩14之間的環狀間隊。 配置提供的注射器支持器1、延長物2以及注射針3使得其可相 對於固定部13轉動，進而使延長物2可以單純的軸向運動來穿刺入隔 膜41，如此可以提供位於隔膜41與延長物2之間的密封髏41、42、 43、44更多的好處’假使注射器支持器1、延長物2以及注射針3已 配置，如此一來其相對於固定部13的轉動被固定，隔膜41透過延長 物2而以混合轉動運動、軸向運動來被穿刺，如此可以提供螺旋轉動 注射器單元1〇〇之扭力需求更多優點。 請參閱第5〜9圖，固定件20包含有一橋臺26,其沿著周緣方向 作動’而固定部13也包含有一橋臺13a，相同地也沿著周緣方向作動， 數個此種橋臺，譬如圖中所緣示的兩個橋臺，也可以分別配置於固定 13 200948406 件20以及固定部13上》 橋臺26、13a形成並定位成緊鄰的一對，如此一來，當注射器單 元100完全螺旋轉動到底的位置時，橋臺26、13a會進入一個轉動橋 臺，而牢固地避免任何進一步的轉動；橋臺13a形成於固定部13的 近端，而橋臺26形成於固定件20的突出物28上，軸向的橋臺亦可 選用而非轉動的橋臺，然而轉動的橋臺具有相較於軸向的橋臺一些優 點，也就是進入橋臺時負擔不會如此大，因為螺紋間距所產生的位移， 而可以藉由轴方向特殊的扭力來達到相較於周緣方向更大的力量。 固定件20可以特別包含有一個或一個以上的突出物24、25，而 可在轉動橋臺到抵達前，快速地拴錢注射器單元1〇〇，如此一來，注 射器單元100的於相反方向的尽向轉動僅可能使用增加的扭力，換句 話說，其僅可能破壞單二元件或是元件的一部件。相同的，亦可選用 孔穴來達到相同目的而取代突出物24、25,當注射器單元1〇〇螺旋鎖 固時，由於栓鎖的緣故，使用者可以藉由手部獲得感觸訊息，來指示 此使用者注射器單元100已經完全旋轉到底；換句話說，其可避免非 必要的反向轉動，而可降低誤用的風險。當孔穴或凸輪之突出物24作 為轉動擋塊時，將可咬合於注射器單元100的外罩14，特別是形成圓 弧狀間陈的面對側，據此一目的，此面對側可包含有至少一個突出物， 可譬如為凸肋、或是凸輪、孔穴等，而可在達到轉動橋臺時或之前快 速地橫擋。 突出物25可以選擇或是額外提供為凸輪的型態，而以端方向突 出，特別是凸輪型態’而可在轉動橋臺到達時或是之前快速地橫擋於 突出物13b，突出物13b配置於固定部13之近端面對側，而且在周緣 方向位移至橋臺13a之前，突出物13b與橋臺13a之間的距離，可以 特別概略對應於突出物25以周緣方向測量的宽度，此意謂著當注射器 單元100完整螺旋轉動到底時，凸輪25於橋臺13a與突出物13b之 間被支撐住。 突出物13b允許反向於旋轉轉動的螺旋運動，而可包含有側翼， 200948406 * 其乃於周緣方向的兩側為平坦化，突出物i3b用以防止此反向於於旋 轉轉動的螺旋運動，舉例來說，可具有蘇齿狀的齒部，由於据齿狀齿 部的陡靖區域’而可用來允許突出物13b橫擋但避免反向轉動。相同 的運用原理也可以用在孔穴或突出物24與外軍14的孔穴或突出物之 間的拴鎖。 在此一實施例中，突出物13b以螺旋狀軌道的型態而配至於固定 部的面對側，此螺旋狀型態概略與固定部13之螺紋的間距相同。 如第10圖所示’為本發明注射器裝置的較佳實施例，此裝置為混 合舆傳遞裝置’以此-目的’以下僅將其_為注射裝置5G來加以代 〇替。注射裝置50包含有外軍51，而外罩51在安瓶承載座20、30内 具有内螺紋（見第7圖），而安瓶承載座2〇、30則有可供鎖固的外螺 紋33，活塞桿52配置於套筒狀外罩51之内，並且連接於一注射按紐 58當;主射裝置50位於初始狀態’換句話說，雙腔體安瓶4〇内的產 品組成物已經混合，注射按鈕58就由外罩51環繞於其軸向長度上， 尤其是整趙全部環繞。徑向朝外的兩側翼57配置於外罩51上，較小 板狀機翼可以讓使用者能更輕易握持住此裝置，並且於混合時提供所 需要的扭力，因此，侧翼57結合抓取部29而可以作為抓取的辅助， 特別能增加直覺性的正確操作，僻翼S7並位於注射裝置的的近端。 〇 在此一較佳實施例中，注射裝置5〇可以包含有外套筒29，其可 作為抓取部，當使用者螺旋轉動外罩51至安瓿承載座時，可供使用者 以單手緊握住，而另外-隻手抓住側翼57，尤其是形成於外套筒29 以及女親容器30之間的圓孤狀間隙，此一優點在於可以允許運動能力 限制的病患穩固地混合產品組成物，在混合順序最後，以及最主要順 序應用，橋臺29a形成於外套筒29的近端，而橋臺54a藉由外罩51 形成於通過轉動、轴向橋臺的末端區域，如此一來，舉例來說，可以 指示使用者合成程序、以及最主要程序已經完成。 在另一個較佳實施例中，注射裝置5〇可以不需要外套筒29，注 射裝置的使用者可以單手緊握於包裝套筒15或是外罩14，且而另外 15 200948406 一手固定於外罩51或是側翼57而達到施加扭力的目的。混合作業也 是類似此實施例的方法，其可包含有套筒狀抓取部29，舉例來說，在 混合程序的最後可以藉由外罩51末端之轉動或是軸向運動橋臺，抵靠 於安瓶承載座20、30的圓振狀周緣抽環，此部份可以參閲第5圖之 元件標號31。在此變化的實施例中，也可以包含有外套筒29，由於注 射器單元100與安瓶承載座20、30之間的轉動橋臺26、13a，而可 以穩固地防止元件由過度復載至捲入構臺，甚至當藉由注射器單元 100來混合的扭力亦同。 ❹ 在兩個實施例中的注射裝置50，當安瓿容器3〇以及外罩51在混 合產品组成物而被媒紋方式相互領固時，活塞桿52通過凸緣46的橋 〇 臺，然後移動到相對於活塞桿52之末端方向的外罩51，而由於凸緣 45、46與安瓿側壁之間的靜摩擦力’使得活塞桿泣相對於安银4〇 依舊維持軸向固定。活塞桿52包含有—孔穴，並形成於橋臺53之末 端，當安瓿容器30被以旋轉鎖固入外罩15時，藉由外罩51所形成 的轴向橋臺56將會沿著橋臺53方向移動，於運動位移中，注射按紐 58於近端突出於外罩51，-旦橋臺56緊鄰抵靠於橋臺53 ,活塞桿 52會跟著從動，如此活塞桿52沿著相對於安瓶容器％以及安瓶4〇 的末端方向，參與料51之轴向運動。活塞桿52接村以在末端方 向位移凸緣46，因此呈現出如上述的混合順序。在混合結束時，拾鎖 元件36可以咕合或是橫擋-拾鎖件54，而可於混合程序結束時指示 使用者，使用者接著搖晃_裝置5G，而使得產品域無合，使用 者可以依序充填裝置，⑽购可鱗在於純4G _ $以 瓶40内移除。根據此-目的，使用者可以將外罩51繼續相對於安瓶 ，器30進行職運動，触緣都會位移，且產品容器的趙積也會降 低’因此，將空氣由產品容器40透過注射器單元1〇〇的流艘通道6、 7、8、10予以驅除。主要順序最後，拾鎮元件36可以與另外一個 樣也形成料罩51之_鎖件55相錄鎖，而可指 要程序的結束。織，在注射針3插人身虹預計的 ^ 16 200948406 置50就準備好進行產品傳遞，初始藉由按壓注射按知58 ,以相對於 外罩51以及安瓶40的末端方向。 所形成的拴鎖件54、55可以在相互作用下產生聽覺或是觸覺的訊 息，尤其是當拴鎖元件36橫擋於拴鎖件54、55時，藉由於拴鎖元件 36上以非對稱於周緣方向來形成側翼，而可實現當拾鎖元件到達 拴鎖件54、55時，任何進一步反向於混合、主要運動的轉動都不再可 能發生。 在此一實施例中，包含有一外套筒29，接續可以連接到安瓶容器 30，如此一來產生轉動方向、軸向的固定，舉例來說，可藉由检領連 〇 接、或是整合成型於安瓿容器30、或是固定件20〇外套筒29可以由 固定件20沿著近端方向足夠延伸，使其近端突出於安瓿4〇的近端， 特別是超出產品容器30的近端。 如第10圖中所繪示的實施例，其優點在於注射裝置5〇的使用者 不會看到任何螺紋，尤其是針對對於關注科技有所懷疑的人們有更大 優點。舉例來說，可以在外罩51的外側上施加彩色條碼，而可額外以 光學方式讀取來確認此裝置已經混合、灌注、或是已經準備用來傳遞 產βρ。舉例來說，可以在混合完成後，施加第一色彩來覆蓋於第一套 筒29外，接著，第二種不同的顏色可以在灌注後，顯現於第二套筒 ® 29上，第三種不同的顏色可以於準備傳遞產品時，指示使用者此一訊 息。為了進一步增加緊握效果，外套筒29可以提供譬如增加摩擦力結 構’譬如凸肋、或是疙瘩、或甚至是增加摩擦力之材料，譬如為橡膠 層等。相同的結構也可以應用於侧翼57上。 雖然本發明以前述之實施例揭露如上，然其並非用以限定本發 明。在不脫離本發明之精神和範圍内，所為之更動與潤飾，均屬本發 明之專利保護範圍。關於本發明所界定之保護範圍請參考所附之申請 專利範圍。 ” 【圖式簡單說明】 17 200948406 第1〜4圖係繪示本發明具轉動穿刺裝置之注射器單元的部件之示意 ISI · 圃， 第5〜6圖係繪示本發明具轉動穿刺裝置之注射器單元的安瓿承載座 的個別部件、以及注射器單元之較佳實施例的示意圖； 第7圓係繪示本發明具轉動穿刺裝置之注射器單元的安瓶承載座容納 安瓶於其中的組合示意圖； 第8圖係繪示本發明具轉動穿刺裝置之注射器單元的第7圖之安瓿承 載座示意圓，並具有注射器單元配至於安瓿承載座以及安瓶上； 第9圈係繪示本發明具轉動穿刺裝置之注射器單元的固定部之較佳實 施例示意圖；以及 © 第10圖係繪示本發明具轉動穿刺裝置之注射器單元的實施裝置之較 佳實施例示意囫。 【主要元件符號說明】 1注射器支持器 2延長物 3注射針 4開口 5鑽孔 6流體通道 Ο 7流體通道 8流體通道 9結合連接裝置 1〇流體通道 12連接部 12a連接突出物 13固定部 13a橋臺 18 200948406 13b突出物 13c圓弧狀溝槽 14外罩 15包裝套筒 20固定件 21螺紋部 22窗口 23孔穴 24突出物 ❹ 25突出物 26橋臺 27凸輪 28突出物 29抓取部/外套筒 30安瓿容器 31圓弧狀周緣軸環 32凸輪 33外螺紋 Ο 34凸輪 35突出物 36拴鎖元件 40安瓿 41密封體/隔膜/凸塊 42密封體 43密封體/凸塊 44密封體/更新部 45第一凸緣 46第二凸緣 200948406 47旁路 48外罩部/圓柱狀中空部位 50注射裝置 51外罩 52活塞桿 53橋臺 54拴鎖件 54a橋臺 55拴鎖件 56橋臺 57側翼 58注射按紐 100注射器單元The fixing member 20 also includes a single-lead or a majority lead end pattern. In this embodiment, the syringe unit 1 is enabled in the form of two threaded portions 21, the thread including The external thread of the fixing portion '13 can be locked on the injection device. When the syringe unit 100 is spirally rotated, the tip end of the extension 2 can penetrate into the diaphragm 41 due to the axial movement of the extension 2, and the torque required to spirally rotate the injector unit 100 can be obtained by the packaging sleeve 15 or the outer cover 14. Applied, once the syringe unit 1 has been completely helically rotated to the end, its position can be as in the eighth aspect. In this embodiment, the opening is located in the ampoule 4'. Thus the end fluid of the injection needle 3 Connected to the inside of the ampoule 4, the end portion of the fixing member 2 is then placed in an annular space between the fixed portion 13 and the outer cover 14. The syringe holder 1, the extension 2 and the injection needle 3 are provided so that they can be rotated relative to the fixing portion 13, so that the extension 2 can be simply inserted into the diaphragm 41 by axial movement, so that the diaphragm 41 can be provided and extended. More advantages of the seals 41, 42, 43, 44 between the objects 2, provided that the syringe holder 1, the extension 2, and the injection needle 3 have been configured so that their rotation relative to the fixed portion 13 is fixed, the diaphragm 41 is pierced by the mixing rotary motion and the axial movement through the extension 2, which can provide more advantages of the torque requirement of the helically rotating syringe unit 1 . Referring to Figures 5-9, the fixing member 20 includes a bridge 26 that moves in the circumferential direction, and the fixing portion 13 also includes a bridge 13a, which also operates along the peripheral direction, and several such abutments The two abutments shown in the figure may also be respectively disposed on the fixed 13 200948406 20 and the fixed portion 13. The abutments 26, 13a are formed and positioned in close proximity, so that when the injector unit When the 100-spindle is completely rotated to the bottom position, the abutments 26, 13a enter a rotating abutment to securely avoid any further rotation; the abutment 13a is formed at the proximal end of the fixed portion 13, and the abutment 26 is formed on the fixed member On the protrusion 28 of 20, the axial abutment can also be used instead of the rotating abutment, however, the rotating abutment has some advantages over the axial abutment, that is, the burden is not so great when entering the abutment. Because of the displacement caused by the pitch of the thread, a special torque can be achieved by the axial direction to achieve a greater force than the circumferential direction. The fixture 20 can include, in particular, one or more protrusions 24, 25, and can quickly dispense the injector unit 1 转动 before rotating the abutment, such that the injector unit 100 is in the opposite direction It is only possible to use the increased torque in the best direction of rotation, in other words, it may only destroy a single component or a component of the component. Similarly, holes can be selected to achieve the same purpose instead of the protrusions 24, 25. When the syringe unit 1 is screwed, the user can obtain a feeling message by hand to indicate this. The user injector unit 100 has been fully rotated to the end; in other words, it avoids unnecessary reverse rotation and reduces the risk of misuse. When the protrusion or the protrusion 24 of the cam acts as a rotation stop, it can be engaged with the outer cover 14 of the injector unit 100, in particular, the facing side of the arc-shaped space. For this purpose, the facing side can include At least one of the protrusions, such as a rib, or a cam, a hole, or the like, can be quickly traversed when or before the rotating abutment is reached. The protrusion 25 can be selected or additionally provided as a cam type, and protrudes in the end direction, in particular a cam type, and can be quickly traversed to the protrusion 13b when the rotating abutment arrives or before, the protrusion 13b The distance between the protrusion 13b and the abutment 13a is particularly roughly corresponding to the width of the protrusion 25 measured in the circumferential direction before being disposed on the opposite side of the proximal end of the fixing portion 13 and before being displaced to the abutment 13a in the circumferential direction. This means that the cam 25 is supported between the abutment 13a and the projection 13b when the syringe unit 100 is completely rotated to the bottom. The protrusion 13b allows a helical movement opposite to the rotational rotation, and may include a side flap, which is flattened on both sides in the circumferential direction, and the protrusion i3b serves to prevent this spiral movement from rotating in rotation. For example, a tooth that may have a serrated shape may be used to allow the projection 13b to traverse but avoid reverse rotation due to the steepened region of the toothed tooth. The same principle of operation can also be used for the shackles between the holes or protrusions 24 and the holes or protrusions of the outer army 14. In this embodiment, the projections 13b are fitted to the facing side of the fixing portion in the form of a spiral track which is substantially the same as the pitch of the threads of the fixing portion 13. As shown in Fig. 10, the preferred embodiment of the injector device of the present invention is a hybrid sputum transfer device. The purpose of this is to replace it with the injection device 5G. The injection device 50 includes a foreign army 51, and the outer cover 51 has internal threads in the ampoules 20, 30 (see Figure 7), while the ampoules 2, 30 have external threads 33 for locking. The piston rod 52 is disposed within the sleeve-like outer cover 51 and is coupled to an injection button 58. The primary projecting device 50 is in an initial state. In other words, the product composition in the double-cavity ampoule has been mixed. The injection button 58 is surrounded by the outer cover 51 over its axial length, in particular the entire circumference. The radially outwardly facing side flaps 57 are disposed on the outer cover 51. The smaller plate-like wings allow the user to more easily hold the device and provide the required torque when mixing, so that the side flaps 57 are combined with the gripping The portion 29 can be used as an aid to the gripping, in particular to increase the intuitive correct operation, and the slinger S7 is located at the proximal end of the injection device. In this preferred embodiment, the injection device 5 can include an outer sleeve 29 that can serve as a gripping portion for the user to grip with one hand when the user rotates the outer cover 51 to the ampoule carrier. Live, and additionally - only the hand grasps the side flaps 57, especially the round solitary gap formed between the outer sleeve 29 and the female parent container 30. This has the advantage of allowing the patient with limited exercise capacity to stably mix the product components. At the end of the mixing sequence, and in the most important sequential application, the abutment 29a is formed at the proximal end of the outer sleeve 29, and the abutment 54a is formed by the outer cover 51 at the end region of the axial abutment through the rotation, thus For example, the user can be instructed to synthesize the program, and the most important program has been completed. In another preferred embodiment, the injection device 5A may not require an outer sleeve 29, and the user of the injection device can grip the package sleeve 15 or the outer cover 14 with one hand, and the other 15 200948406 is fixed to the outer cover with one hand. 51 or the side wing 57 to achieve the purpose of applying torque. The mixing operation is also a method similar to this embodiment, which may include a sleeve-like gripping portion 29, for example, at the end of the mixing procedure, by the rotation of the end of the outer cover 51 or the axial movement of the abutment, against The circular vibration peripheral ring of the ampoules 20, 30 can be referred to the component number 31 of Fig. 5. In this variant embodiment, an outer sleeve 29 can also be included, which can be reliably prevented from being over-reloaded due to the rotating abutments 26, 13a between the syringe unit 100 and the ampoules 20, 30. It is entangled in the gantry even when the torque is mixed by the injector unit 100. ❹ In the injection device 50 of the two embodiments, when the ampoule container 3 and the outer cover 51 are mutually woven by the media pattern in the mixed product composition, the piston rod 52 passes through the bridge of the flange 46 and then moves to The outer cover 51 with respect to the end direction of the piston rod 52, and the static friction force ' between the flanges 45, 46 and the side walls of the ampoule, causes the piston rod to remain axially fixed relative to the An Ying 4 。. The piston rod 52 includes a cavity formed at the end of the abutment 53. When the ampoule container 30 is rotationally locked into the outer cover 15, the axial abutment 56 formed by the outer cover 51 will follow the abutment 53. The direction moves, in the motion displacement, the injection button 58 protrudes from the outer cover 51 at the proximal end, and the abutment 56 abuts against the abutment 53, the piston rod 52 will follow, so that the piston rod 52 is along the opposite The bottle container % and the end direction of the ampule 4 参与 participate in the axial movement of the material 51. The piston rod 52 is connected to the village to displace the flange 46 in the distal direction, thus exhibiting a mixing sequence as described above. At the end of the mixing, the pick-up element 36 can be twisted or traverse-pick-up 54 and the user can be instructed at the end of the mixing process, the user then shaking the device 5G, leaving the product domain unfit, the user The device can be filled in sequence, and (10) the scale can be removed in the bottle 40 in pure 4G _ $. According to this-purpose, the user can continue to move the outer cover 51 relative to the ampoules, the device 30, the touch will be displaced, and the product of the product container will also decrease. Therefore, the air is transmitted from the product container 40 through the injector unit 1. The rafting channels 6, 7, 8, and 10 are removed. In the final sequence, the pick-up element 36 can be recorded with another lock that is also formed by the lock member 55 of the hood 51, and can refer to the end of the program. Weaving, the injection of the needle 3 into the body is expected to be 50, ready for product delivery, initially by pressing the injection button 58 to the end direction of the outer cover 51 and the ampoule 40. The formed latching members 54, 55 can create an audible or tactile message under interaction, particularly when the latching member 36 is traversed by the latch members 54, 55 by virtue of the asymmetry of the latching member 36. The flank is formed in the circumferential direction, so that when the pick-up element reaches the latch members 54, 55, any further rotation against the mixing, the main motion is no longer possible. In this embodiment, an outer sleeve 29 is included, which can be connected to the ampoules container 30, thereby generating a rotational direction and an axial fixation, for example, by detecting a splicing connection, or Integrated into the ampoule container 30, or the securing member 20, the outer sleeve 29 can be extended sufficiently by the securing member 20 in the proximal direction such that its proximal end projects beyond the proximal end of the ampoule 4, particularly beyond the product container 30. Near end. The embodiment shown in Fig. 10 has the advantage that the user of the injection device 5 does not see any threads, especially for those who have doubts about technology. For example, a color bar code can be applied on the outside of the outer cover 51, and an additional optical read can be made to confirm that the device has been mixed, filled, or ready to deliver a beta. For example, a first color may be applied to cover the outside of the first sleeve 29 after the mixing is completed, and then a second different color may appear on the second sleeve® 29 after filling, the third Different colors can indicate the user's message when the product is ready to be delivered. To further increase the gripping effect, the outer sleeve 29 can provide, for example, a material that increases the frictional structure, such as ribs, or ridges, or even frictional forces, such as a rubber layer. The same structure can also be applied to the side flaps 57. Although the present invention has been disclosed above in the foregoing embodiments, it is not intended to limit the invention. Modifications and modifications are within the scope of the invention as defined by the scope of the invention. Please refer to the attached patent application for the scope of protection defined by the present invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 to FIG. 4 are schematic diagrams showing the components of the syringe unit of the present invention having a rotary puncture device, and FIGS. 5 to 6 are diagrams showing the syringe having the rotary puncture device of the present invention. A schematic diagram of a preferred embodiment of the unit of the ampoule carrier and the syringe unit; the seventh circle shows a combination diagram of the ampoule carrier of the syringe unit with the rotary puncture device of the present invention for accommodating the ampoule therein; 8 is a schematic circle diagram of the ampoule carrier of FIG. 7 of the syringe unit with a rotary puncture device of the present invention, and has a syringe unit coupled to the ampoule carrier and the ampoule; and the ninth circle shows the rotation puncture of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 10 is a schematic view showing a preferred embodiment of an apparatus for implementing a syringe unit having a rotary puncturing device according to the present invention. [Signal Description of Main Components] 1 Syringe Holder 2 Extension 3 Injection Needle 4 Opening 5 Drilling 6 Fluid Channel Ο 7 Fluid Channel 8 Fluid Channel 9 Combined with Connection Device 1 〇 Fluid Channel 12 connecting portion 12a connecting protrusion 13 fixing portion 13a abutment 18 200948406 13b protrusion 13c arc-shaped groove 14 outer cover 15 packaging sleeve 20 fixing member 21 thread portion 22 window 23 hole 24 protrusion ❹ 25 protrusion 26 abutment 27 cam 28 protrusion 29 gripping portion / outer sleeve 30 ampoules container 31 arc-shaped peripheral collar 32 cam 33 external thread Ο 34 cam 35 protrusion 36 拴 lock element 40 ampule 41 sealing body / diaphragm / bump 42 seal Body 43 Sealing Body / Bump 44 Sealing Body / Renewing Portion 45 First Flange 46 Second Flange 200948406 47 Bypass 48 Housing Part / Cylindrical Hollow Portion 50 Injection Device 51 Housing 52 Piston Rod 53 Abutment 54 Locking Member 54a abutment 55 shackle 56 abutment 57 flank 58 injection button 100 syringe unit