514539 A7 _:__ B7 五、發明說明(1 ) 發明領域 本發明相關於根據申請專利範圍的獨立項的前言部份 的注射益裝置,具有壓力室的注射器單元,以及實施注身寸 的方法。 發明背景 本發明的原理可與要被注射的流體必須被高位準地加 壓的任何注射器一起使用。高壓力可能是需要用來排出高 黏性製品,例如油,凝膠,糊狀物,非晶,或懸浮形式的 製品,以例如用於牙齒醫療的目的或是在體內形成緩慢釋 放的澱積物。需要高壓力的另一種主要注射器型式爲以下 會更進一步討論的用於加壓液體的無針表皮穿透的噴射注 射器。雖然爲方便起見,以下會就此種噴射注射來敘述本 發明,但是本.發明不應被視爲受限於此,而應瞭解本發明 也涵蓋其他的高壓力應用。 經濟部智慧財產局員工消費合作社印製 用來在充分的高壓下將醫藥液體經由人或動物的皮膚 表面或黏液膜片而皮下噴射注射以迫使液體至在皮膚表面 下方的組織內的預定深度的噴射注射裝置在此技術領域中 已知多年。 從美國專利第2,8 2 1 ,9 8 1號已知一種採用噴 射注射原理的多發注射器儀器。在此已知的儀器中,要被 注射的流體從例如爲傳統的注射器的形式的近端流體醫藥 室被進給至一遠端壓力室,亦即安瓦(ampoule )。一機構 被用來將流體從流體室傳遞至壓力室內,然後另一機構被 -4- 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) 514539514539 A7 _: __ B7 V. Description of the invention (1) Field of the invention The present invention relates to an injection device, a syringe unit with a pressure chamber, and a method for carrying out a body fit according to the preamble of the independent part of the scope of patent application. BACKGROUND OF THE INVENTION The principles of the present invention can be used with any syringe where the fluid to be injected must be pressurized at a high level. High pressure may be required to expel highly viscous products such as oils, gels, pastes, amorphous, or suspended forms, for example for dental medical purposes or to form slow-release deposits in the body Thing. Another major type of syringe that requires high pressure is a needle-free epidermal jet injector for pressurized liquids, discussed further below. Although, for convenience, the invention will be described below with respect to such jet injection, the invention should not be considered as being limited thereto, but it should be understood that the invention also covers other high pressure applications. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs for injecting medicinal liquids through human or animal skin surfaces or mucous membranes under sufficient high pressure to inject the liquid to a predetermined depth in the tissue below the skin surface Jet injection devices have been known in the art for many years. From U.S. Patent Nos. 2,82,9,81, a multi-injector instrument using the principle of jet injection is known. In this known instrument, the fluid to be injected is fed from a proximal fluid medicine room, for example in the form of a conventional syringe, to a distal pressure chamber, i.e. ampoule. One mechanism is used to transfer fluid from the fluid chamber to the pressure chamber, and then the other mechanism is used. -4- This paper size applies to China National Standard (CNS) A4 (210 X 297 mm) 514539
經濟部智慧財產局員工消費合作社印製 用來實施注射。止回閥設置在傳遞孔中以確保不發生任何 回流。噴射器儀器的機械上相當複雜的結構使得其之製造 相當額貴。此類型的複雜機械儀器的另一缺點在於難以在 無菌環境中組裝裝置。現今有時會要求在注射期間可能會 被污染的零件不能再被使用(需爲用後丟棄式)。美國專 利第2,821 ,981號中所揭示的裝置類型或是一般 而言此種機械複雜的裝置非常難以符合此要求,因爲有大 量的不同零件構成此種裝置。 美國專利第3,1 3 8,2 5 7號揭示類似美國專利 第2,8 2 1 ,9 8 1號中的注射器裝置。 美國專利第4,447,225號揭示一種_多劑噴射 注射器,其可接收一醫藥瓶或小玻璃瓶,而醫藥液體從該 瓶傳遞至一傳遞室內。然後,醫藥經由一插管(cannula )被泵啷通過一單向閥至一醫藥輸送室內。此時,醫藥準 備好被噴射注射輸送,此係藉著對醫藥流體施加射出力W 因而將其排出通過噴射注射器的孔口來實施。美國專利第 4,4 4 7,2 2 5號中所揭示的噴射注射器的一缺點在 於其在結構上很複雜,例如醫藥液體在注射前的兩步,驟傳 遞,因而製造很昂貴。 美國專利第2,59 1 ,046號揭示一種皮下注射 器總成,其具有由一旁通部份分離的二容室。液體醫藥經 由旁通部份而傳遞至遠端容室內。並無任何分開的容室司" 提供不同的性質’例如對高壓力的抵抗力° 注射用的液體醫藥在被載入注射用的注射器之前@ 本紙張尺度適用中國國家標準(CNS ) A4規格(210X 297公釐) (請先閱讀背面之注意事項再填寫本頁)Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs for injections. A check valve is placed in the transfer hole to ensure that no backflow occurs. The mechanically complex structure of the ejector instrument makes its manufacture quite expensive. Another disadvantage of this type of complex mechanical instrument is that it is difficult to assemble the device in a sterile environment. Today it is sometimes required that parts that may become contaminated during the injection can no longer be used (need to be discarded after use). The type of device disclosed in U.S. Patent No. 2,821,981 or, generally speaking, such a mechanically complex device is very difficult to meet this requirement because a large number of different parts constitute such a device. U.S. Patent No. 3,138,257 discloses a syringe device similar to that of U.S. Patent Nos. 2,821,98.1. U.S. Patent No. 4,447,225 discloses a multi-dose injection syringe which can receive a medical bottle or vial, and medical liquid is transferred from the bottle to a transfer chamber. The medicine is then pumped through a cannula through a check valve into a medicine delivery chamber. At this time, the medicine is ready to be delivered by injection, which is implemented by applying an injection force W to the medicine fluid and thereby discharging it through the orifice of the injection syringe. One disadvantage of the injection syringe disclosed in U.S. Patent No. 4,4,47,225 is that its structure is complicated, for example, the medical liquid is transferred in two steps before injection, and thus is expensive to manufacture. U.S. Patent No. 2,591,046 discloses a hypodermic syringe assembly having a two-volume chamber separated by a bypass portion. The liquid medicine is passed to the remote container through the bypass section. There is no separate compartment department " providing different properties' for example, resistance to high pressure ° Liquid medicine for injection before being loaded into the syringe for injection @ This paper size applies to China National Standard (CNS) A4 specifications (210X 297mm) (Please read the notes on the back before filling this page)
-5- 514539 A7-5- 514539 A7
五、發明說明(3 ) (請先閱讀背面之注意事項再填寫本頁) 是儲存在玻璃容器內。然後,一橡膠密封件密封玻璃容器 。如此,液體醫藥只與玻璃及橡膠直接接觸。不使用塑膠 材料成爲醫藥儲存容器的材料的主要原因爲塑膠材料不能 提供完整的封閉密封來阻止氧的移入容器或組份的從容器 移出。並且,來自製造的組份可能澱積在塑膠材料中,此 可能影響儲存在容器中的液體。另一原因在於塑膠材料可 ㊆放出在可注射的製劑中不能接受的痕量組份。上述的與 用於醫藥儲存容器的塑膠材料有關的缺點只有在將塑膠容 器用於常態醫藥儲存時間時才成立,例如長達兩年。在使 用塑膠材料於例如注射器時,液體醫藥只有在實施注射時 才接觸塑膠材料,不能鑑定出上述的缺點。 在使用玻璃容器的噴射注射器中,玻璃容器必須抵抗 用來從容器排出液體的高壓力。因此,玻璃容器最好由硬 化玻璃製成,因而使其額貴。相反的,塑膠材料可輕易地 提供壓力室所需的性質,例如在破碎危險度低之下的強度 及彈性。儲存室用的玻璃材料以及壓力室用的塑膠材料也 適合用於可丟棄式的單次使用組件。 經濟部智慧財產局員工消費合作社印製 本發明的目的爲達成與習知技術已知者相比製造較不 額貴的易於使用的注射器裝置。本發明的另一目的爲達成 不具有上述的與裝置的零件的無菌處理有關的缺點的裝置 。本發明的另一目的爲提供一種注射器裝置,其適合於以 醫藥來預充塡,並且容許在注射前儲存延長的時間週期, 其中與醫藥接觸或是會與醫藥接觸的裝置的所有表面及其 部份可在製造,儲存,及使用期間保持無菌。本發明的另 -6 - 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) 514539 A7 _______ B7 五、發明說明(4 ) 一目的爲提供適合於從一儲存室射出多劑的裝置。本發明 的另一目的爲提供適合於將注射期間可能被污染的部件容 易地更換及丟棄的裝置。本發明的另一目的爲達成設置有 無菌部份的裝置,其固有地不能重新被使用,以防止已經 用過的裝置被未經授權地消毒以及重新販售而危害病人。 本發明也具有提供用來從高壓力源輸送液體的相應方法的 目的。 發明槪說 上述目的是藉著根據申請專利範圍的獨立項的特徵部 份的注射器裝置,具有壓力室的單元,以及實施注射的方 法而達成。較佳實施例在申請專利範圍的附屬項中界定。 如此,達成具有極少的可移動部件且易於製造的易於 \ 使用的注射器裝置。此注射器可被用於任何的高壓注射器 丨 • · '1 應用,可預先充塡醫藥且在醫藥不劣化下儲存,並且可在 j 無菌情況下製造,儲存,以及使用。 經濟部智慧財產局員工消費合作社印製 根據本發明的注射器裝置較佳地被設計用於多劑注射 。此注射器裝置包含一分開的單元,其包含不能被重新使 用的壓力室。用過的單元在使用後被丟棄,並且當要給予 新的注射時,新的單元被附著於注射器殻體。 根據本發朋的一較佳實施例,液體從儲存室被壓入壓 力室內,導致不須實施將液體抽吸至壓力室內,要達成後 者在結構上較爲複雜。 根據另一較佳實施例,負責液體醫藥的劑量給予的機 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) 514539 A7 ________B7 五、發明說明(5 ) 構與注射機構分開。 與從儲存室經由液體導管而傳遞至壓力室內的劑量體 積有關的來自劑量給予單元的資訊被供應至一控制裝置, 而其又產生或爲一電訊號或爲一機械移動的控制訊號至至 一加壓機構。控制訊號控制壓力室中的活塞的移動,使得 其移動至沒有任何空氣留在壓力室中的位置。 根據本發明的另一實施例,一機械式劑量給予單元是 藉著旋轉移動而被使用。此移動是儲存在一機械式(或電 子式)記憶體中,以由加壓機構來使用。 圖式簡要敘述 (請先閱讀背面之注意事項再辦寫本頁) 置 裝 裝 驟 步 同 不 的 法 方 的 明 發 本 據據 根根 示示 顯顯 c B 12 至及 A A 12 圖圖 第 的 明 發 本 器 射 注 的 例 施 二 第 的 明 發 5 裝本 似據 類根 示示 顯顯 D E 2 3 及至, c A 2 3 圖圖 裝 制 控 的 中 器 射 注 的 例 施 . -線- 經濟部智慧財產局員工消費合作社印製 另 的 份 β, 咅 通 旁 的 明 發 本 據 根 示 顯 Β 4 及。 Α 圖 4 面 圖剖 的 例 裝 器 。 射元 注單 劑開 多分 勺 勺 白 白 明明 發發 本,本 據據 根根 示示 顯顯 5 6 圖圖 構 機 射 注 圖及 與, 可氣 示除 顯 , F 定 7 設 至量 A 劑 7 的 圖.用 使 起 至 A 3 例 施 實 置 裝 的 E 3 施 適 度 尺 張 紙 準 標 家 國 國 釐 公 97 2 X 110 2 ¥( 規 514539 A7 經濟部智慧財產局員工消費合作社印製 五、 發明說明(6 ) 主要元件對照 2 壓力室 4 壓力筒管 6 前端開口 8 開口 8 液體 8 儲存筒管 1 〇 液體醫藥 1 2 活塞 1 3 槽道 1 4 液體噴射流 1 6 儲存室 1 7 柱塞 1 8 膜片 1 9 推桿 2 〇 儲存活塞 2 2 導管 2 3 針件 2 4 劑量給予單元 2 5 劑量設定鈕 2 6 加壓機構 2 8 控制單元 2 9 連接部份 3 0 活塞桿 II訂 線丨爾------------------- (請先閱讀背面之注意事項再填寫本頁) 本紙張尺度適用中國國家標準(CNS)A4規格(210 χ 297公釐) 514539 A7 B7 五、發明說明(7 ) 經濟部智慧財產局員工消費合作社印製 3 2 中 心 槽 道 3 4 針件 後 方 針 件 3 6 後 方 支 座 3 8 旁 通 部 份 4 〇 衝 柱 4 2 密 封 構 件 5 1 殼 體 5 3 指 示 器 5 5 三田 日周 整 控 制 器 5 7 預 備 注 射 的 機 構 5 9 釋 放 扳 機 6 1 指 示 窗 □ 6 3 分 開 單 元 6 5 .封 閉 覆 蓋 6 6 可 移 去 膜 6 7 螺 紋 7 〇 〇 裝 置 7 〇 1 可 丟 棄 部 份 7 〇 2 可 重 新 使 用 部 份 7 1 〇 殻 體 7 1 1 前 方 內 螺 紋 7 1 2 狹 縫 7 2 〇 儲 存 室 7 2 2 穿 透 膜 片 (請先閱讀背面之注意事項再V. Description of the invention (3) (Please read the notes on the back before filling this page) It is stored in a glass container. Then, a rubber seal seals the glass container. In this way, liquid medicine is only in direct contact with glass and rubber. The main reason for not using plastic materials for medical storage containers is that plastic materials do not provide a complete hermetic seal to prevent oxygen from moving into the container or components from the container. Also, components from manufacturing may be deposited in plastic materials, which may affect the liquid stored in the container. Another reason is that plastic materials can release trace components that are unacceptable in injectable preparations. The aforementioned disadvantages associated with plastic materials for medical storage containers only hold true when plastic containers are used for normal medical storage time, for example up to two years. When using plastic materials such as syringes, liquid medicines only come into contact with plastic materials during injection, and the above disadvantages cannot be identified. In a jet syringe using a glass container, the glass container must resist the high pressure used to discharge liquid from the container. Therefore, the glass container is preferably made of hardened glass, which makes it expensive. In contrast, plastic materials can easily provide the required properties of the pressure chamber, such as strength and elasticity at a low risk of crushing. Glass materials for storage chambers and plastic materials for pressure chambers are also suitable for disposable single-use components. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economics The purpose of the present invention is to achieve a less expensive and easy-to-use syringe device compared to those known in the art. Another object of the invention is to achieve a device which does not have the disadvantages associated with the aseptic processing of parts of the device as described above. Another object of the present invention is to provide a syringe device that is suitable for prefilling with medicine and allows storage for an extended period of time before injection, wherein all surfaces of the device that are in contact with or will come into contact with medicine and their Portions can be kept sterile during manufacture, storage, and use. Another -6 of this invention-This paper size is applicable to Chinese National Standard (CNS) A4 specification (210 X 297 mm) 514539 A7 _______ B7 V. Description of the invention (4) The purpose is to provide suitable for multiple shots from a storage room installation. It is another object of the present invention to provide a device suitable for easily replacing and discarding components that may be contaminated during injection. Another object of the present invention is to achieve a device provided with a sterile portion, which inherently cannot be reused, to prevent the used device from being endangered by unauthorized disinfection and resale of the patient. It is also an object of the present invention to provide a corresponding method for transporting liquid from a high pressure source. SUMMARY OF THE INVENTION The above-mentioned object is achieved by a syringe device according to a characteristic part of an independent item in the scope of patent application, a unit having a pressure chamber, and a method for performing injection. The preferred embodiments are defined in the appendix to the scope of the patent application. In this way, an easy-to-use syringe device with few moving parts and easy manufacturing is achieved. This syringe can be used in any high-pressure syringe 丨 • · '1 application, can be prefilled with medicine and stored without deterioration, and can be manufactured, stored, and used under aseptic conditions. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs The syringe device according to the present invention is preferably designed for multi-dose injection. This syringe device contains a separate unit that contains a pressure chamber that cannot be reused. The used unit is discarded after use, and when a new injection is to be given, the new unit is attached to the syringe housing. According to a preferred embodiment of the present invention, the liquid is pressed into the pressure chamber from the storage chamber, so that it is not necessary to perform the suction of the liquid into the pressure chamber, and the latter is more complicated in structure. According to another preferred embodiment, the size of the machine-made paper responsible for the dose administration of liquid medicine applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) 514539 A7 ________B7 V. Description of the invention (5) The structure is separated from the injection mechanism . Information from the dosing unit relating to the volume of the dose transferred from the storage chamber to the pressure chamber via the liquid conduit is supplied to a control device, which in turn generates either a telecommunication signal or a mechanically moving control signal to a Pressure mechanism. The control signal controls the movement of the piston in the pressure chamber so that it moves to a position where no air remains in the pressure chamber. According to another embodiment of the present invention, a mechanical dosing unit is used by rotating movement. This movement is stored in a mechanical (or electronic) memory for use by a pressurizing mechanism. Brief description of the diagram (please read the precautions on the back before writing this page) According to the basic instructions of the legal party, the installation process is different from that shown in c B 12 to AA 12 Example of Mingfa's local device injection. The second Mingfa 5 device is similar to DE 2 3 and c A 2 3 according to the type of display. -Line- The Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs printed another copy of β. Α Figure 4 is an example of a cross-sectional view of the mounting device. Shooting Yuan injection of single agent, multi-spoon spoon, Bai Baimingming hair, according to the root display shows the display 5 6 maps and shots, and can be displayed in addition, F set 7 set to the amount of A agent 7 The figure is shown in Figure 3. Using E 3 with a moderate size of paper installed on the A 3 case, the standard size of the country is 97 2 X 110 2 ¥ (Reg. 514539 A7, printed by the Consumers ’Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs. Description of the invention (6) Comparison of main components 2 Pressure chamber 4 Pressure tube 6 Front end opening 8 Opening 8 Liquid 8 Storage tube 1 〇 Liquid medicine 1 2 Piston 1 3 Channel 1 4 Liquid jet 1 6 Storage chamber 1 7 Column Plug 1 8 Diaphragm 1 9 Push rod 2 〇 Storage piston 2 2 Catheter 2 3 Needle 2 4 Dose administration unit 2 5 Dose setting button 2 6 Pressure mechanism 2 8 Control unit 2 9 Connection part 3 0 Piston rod II Line 丨 Seoul ------------------- (Please read the precautions on the back before filling out this page) This paper size is applicable to China National Standard (CNS) A4 (210 χ 297 mm) 514539 A7 B7 V. Description of Invention (7) Ministry of Economic Affairs Printed by the Intellectual Property Bureau employee consumer cooperative 3 2 Center channel 3 4 Needle piece Rear guide piece 3 6 Rear support 3 8 Bypass part 4 〇Punch 4 2 Sealing member 5 1 Housing 5 3 Indicator 5 5 Sanda Day and week controller 5 7 Injection preparation mechanism 5 9 Release trigger 6 1 Indication window □ 6 3 Separate unit 6 5. Closed cover 6 6 Removable membrane 6 7 Thread 7 〇〇Device 7 〇1 Disposable part 7 〇2 Reusable part 7 1 〇Housing 7 1 1 Front female screw 7 1 2 Slot 7 2 〇Storage compartment 7 2 2 Penetrating the diaphragm (Please read the precautions on the back before
-線· 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) -10- 514539 A7 B7 五、發明說明(8 ) 經濟部智慧財產局員工消費合作社印製 7 2 4 儲 存 活 塞 7 2 6 後 端 7 3 〇 注 射 單 元 7 3 1 衝 柱 7 3 2 刖 方 凸 緣 7 3 3 後 方 凸 緣 7 3 6 弓早 簧 7 3 4 衝 柱 支 座 7 3 5 支 撐 凸 緣 7 3 6 彈 簧 7 3 7 扳 機 鈕 7 4 〇 除 氣 單 元 7 4 1 轉 移 元 件 7 4 2 丄/ · 刖 端 7 4 3 後 方 推 動 凸 緣 7 4 4 中 心 孔 7 5 〇 液 體 傳 遞 單 元 7 5 1 螺 紋 柱 塞 7 5 2 螺 母 7 6 〇 控 制 單 元 7 6 1 鼓 件 7 6 2 軌 道 7 6 3 螺 旋 延 伸 部 份 7 6 4 膝 部 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) -11 - 514539 A7 B7 五、發明說明(9 ) 7 6 5 筆 直 部 份 7 6 6 推 桿 7 6 7 軌 道 從 動 件 7 6 8 表 面 7 6 9 後 方 螺 紋 7 7 0 致 動 單 元 7 7 1 手 動 控 制 旋 鈕 7 7 2 螺 釘 7 7 3 回 動 彈 簧 7 7 4 內 部 旋 鈕 套 筒 D 液 體 的 局 度 d 距 離 L — D 空 氣 局 度 (請先閱讀背面之注意事項再填寫本頁)-Line · This paper size is in accordance with Chinese National Standard (CNS) A4 (210 X 297 mm) -10- 514539 A7 B7 V. Description of the invention (8) Printed by the Consumers ’Cooperative of Intellectual Property Bureau of the Ministry of Economic Affairs 7 2 4 Storage piston 7 2 6 Back end 7 3 〇 Injection unit 7 3 1 Punch 7 3 2 Square flange 7 3 3 Rear flange 7 3 6 Bow spring 7 3 4 Punch holder 7 3 5 Support flange 7 3 6 Spring 7 3 7 Trigger button 7 4 〇Degassing unit 7 4 1 Transfer element 7 4 2 丄 / · 刖 end 7 4 3 Push the flange 7 4 4 Center hole 7 5 〇 Liquid transfer unit 7 5 1 Threaded plunger 7 5 2 Nut 7 6 〇 Control unit 7 6 1 Drum piece 7 6 2 Track 7 6 3 Spiral extension 7 6 4 Knee This paper size applies to China National Standard (CNS) A4 (210 X 297 mm) -11-514539 A7 B7 V. Description of the invention (9) 7 6 5 Straight part 7 6 6 Push rod 7 6 7 Track follower 7 6 8 Surface 7 6 9 Rear thread 7 7 0 Actuation Unit 7 7 1 Manually controlled rotary knob 7 7 2 Screw 7 7 3 Spring spring 7 7 4 Internal knob sleeve D Liquid level d Distance L — D Air level (Please read the precautions on the back before filling this page)
1^·' 經濟部智慧財產局員工消費合作社印製 本發明的較佳實施例的詳細敘述 相應的特徵部份在所有的圖中具有相同的參考數字。 根據本發明的方法的基本步驟顯示在圖1 A至1 C中 〇 壓力室2包含設置有用來射出液體的前端開口 6的壓 力筒管4,接收來自儲存室(未顯示)的液體醫藥1 〇的 開口 8,以及密封地插入在壓力筒管中的活塞1 2。 圖1 A顯示裝入步驟,其中預定體積的液體經由開口 8而裝入壓力筒管內。裝入的體積比壓力筒管在活塞1 2 上方的體積小。在此步驟中,活塞位於其裝入位置。壓力 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) -12- 514539 A7 -—^ _ B7 五、發明說明(10 ) 室的直立位置與表面張力結合來防止傳遞的液體經由開口 6逸出。從圖中可見,開口 8靠近活塞,以從底部充塡壓 力筒管來迫使空氣於朝向開口 6的方向。 圖1 B顯示密封步驟,其中活塞1 2已從裝入位置移 動至密封位置,因而密封開口 8而與儲存室隔離。活塞所 移動的距離與液體醫藥的體積有關,使得當活塞位於其密 封位置時,大致上所有的空氣均經由前端開口從壓力室被 排出。圖1 B顯示最大劑量的液體傳遞至壓力室內的情況 。如果劑量較小,則活塞當然是在更遠端的位置。 圖1 C顯示射出步驟,其中一力施加在活塞上而迫使 其於遠端方向,因而經由前端開口將液體醫藥射出成爲液 體噴射流1 4。 經濟部智慧財產局員工消費合作社印製 圖2 A及2 B顯不根據本發明的第一'實施例的注射器 裝置。圖中所示的從一高壓力源輸送液體的注射器裝置包 含一壓力室2 ,其包含一壓力筒管4,用來容納插入在壓 力筒管中的至少一壓力活塞1 2 ,並且具有用來射出液體 8的前端開口 6。壓力室具有充分的強度,以在注射期間 支承液體壓力,並且較佳地爲可丟棄式以及由塑膠製成。 此裝置另外包含與壓力室分開的一儲存室1 6 ,供液 體或液體先質組份用。儲存室較佳地由玻璃製成’並且具 有圓柱形的形狀。儲存室設置有在一端部處的一膜片1 8 ,以及從另一端部插入的一可移動的密封儲存活塞。膜片 及活塞圍封液體。 一導管2 2配置在壓力室與儲存室之間。導管較佳地 -13- 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) 514539 A7 _ B7 五、發明說明(11 ) (請先閱讀背面之注意事項再填寫本頁) 爲壓力室的一整體部份,並且設置有具有與導管連接的槽 道的針件2 3。針件可穿透儲存室的膜片1 8 ,以建立儲 存筒管8與壓力筒管4之間的流體連接。 此裝置也包含一劑量給予單元2 4,一加壓機構2 6 ’以及一控制單元2 8。 劑量給予單元可在儲存室內部的儲存活塞上施加一力 ’以將預定體積的液體從儲存室經由導管而傳遞至壓力筒 管內。所傳遞的體積取決於儲存活塞所移動的距離d。虛 線顯示當已經傳遞一劑量時儲存活塞的位置。 加壓機構被配置來在壓力筒管中的壓力活塞上施加一 力,以產生液體壓力。 加壓機構被配置成在活塞上直接或間接施力。此機構 在圖中只是示意地顯示,並且可例如爲美國專利第 4 ’ 4 4 7 ,2 2 5號中所揭示的彈簧加載者。另一原理 則是根據壓力下的氣體所產生的注射力。此二原理在此技 術領域中爲已知的。注射期間壓力室內部的壓力是在 4000psi (磅/平方英吋)的數量級。 經濟部智慧財產局員工消費合作社印製 當一劑量已經被傳遞至壓力筒管內時,與所傳遞的體 積有關的資訊從液體傳遞單元應用於控制單元2 8。控制 單元控制加壓機構來首先將壓力筒管中的壓力活塞從裝入 位置(圖2 A )移動至密封位置(圖2 B )。此移動與體 積有關’使得當壓力活塞1 2位於密封位置時,大致上所 有的空氣均經由前端開口從壓力筒管被排出。在此之後, 加壓機構在被要求時產生必要的力來將液體經由前端開口 -14- 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) 514539 Α7 Β7 五、發明說明(12 ) 排出。此在此處顯示成爲柱塞1 7相對於加壓機構2 6的 向前移動。 圖2 C及2 D顯示後方控制部份有稍微不同的佈局白勺 類似設計。劑量給予單元2 4配備有一劑量設定鈕2 5 ’ 並且可用任何已知的配置例如螺釘及螺母配置來將鈕2 5 的旋轉及/或軸向位移轉變成用於儲存活塞2 0的推桿 1 9的向前移動,用來給予液體劑量通過導管2 2並且Μ 壓力室2內。圖2 C顯示已經發生此劑量傳遞之後但是在 除氣之前的裝置。圖2 D顯示除氣之後的裝置。在圖2 C 與圖2 D之間,加壓機構2 6已經相對於壓力室2並且也 相對於容納劑量給予單元2 4及控制單元2 8的箱件向前 移動,此可從二者之間的連接部份2 9的不同位置看出’ 但是柱塞1 7尙未相對於加壓機構2 6向前移動。控制機 構被配置成爲在鈕2 5有較小的劑量傳遞移動時給予加壓 機構較大的向前位移,反之則較小,使得加壓機構2 6的 除氣向前移動與傳遞至壓力室2的劑量體積互補。在除氣 之後,加壓機構可被觸發來實施注射。加壓機構的在柱塞 固定不動之下的軸向可移動能力方便此部份的設計,例如 用彈簧及扳機,因爲其不須含有任何除氣用的配置。 壓力室,壓力筒管內部的活塞,以及導管的至少一部 份被配置成爲較佳地爲可丟棄式的一分開單元。儲存室, 加壓機構,劑量給予單元,以及控制裝置係配置在一殼體 中。 分開單元與殼體具有相應的裝配部份,其允許單元在 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) 請 先 閱 讀 背 面 之 注 意 事 項1 ^ · 'Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economics A detailed description of the preferred embodiment of the present invention The corresponding features have the same reference numerals in all the figures. The basic steps of the method according to the invention are shown in Figs. 1A to 1C. The pressure chamber 2 contains a pressure barrel 4 provided with a front end opening 6 for ejecting liquid, and receives liquid medicine 1 from a storage chamber (not shown). The opening 8 and the piston 12 sealedly inserted in the pressure cylinder. FIG. 1A shows the filling step, in which a predetermined volume of liquid is filled into the pressure tube via the opening 8. The volume installed is smaller than the volume of the pressure tube above the piston 1 2. In this step, the piston is in its loading position. Pressure This paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) -12- 514539 A7--^ _ B7 V. Description of the invention (10) The upright position of the chamber is combined with the surface tension to prevent the transmitted liquid Escapes through the opening 6. As can be seen from the figure, the opening 8 is close to the piston, so that a pressure tube is charged from the bottom to force the air toward the opening 6. Fig. 1B shows a sealing step in which the piston 12 has been moved from the loading position to the sealing position, thus sealing the opening 8 and isolating it from the storage chamber. The distance the piston moves is related to the volume of the liquid medicine, so that when the piston is in its sealed position, substantially all the air is expelled from the pressure chamber through the front opening. Figure 1B shows the maximum dose of liquid delivered to the pressure chamber. If the dose is smaller, the piston is certainly in a more distal position. Fig. 1C shows the injection step, in which a force is applied to the piston to force it in the distal direction, and thus the liquid medicine is ejected into a liquid jet stream 14 through the front opening. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs Figures 2A and 2B show a syringe device according to the first embodiment of the present invention. The illustrated syringe device for delivering liquid from a high pressure source includes a pressure chamber 2 including a pressure barrel 4 for receiving at least one pressure piston 12 inserted in the pressure barrel, and having The front end 6 of the ejected liquid 8. The pressure chamber is sufficiently strong to support the pressure of the liquid during the injection, and is preferably disposable and made of plastic. This device additionally contains a storage chamber 16 separate from the pressure chamber for liquid or liquid precursor components. The storage chamber is preferably made of glass' and has a cylindrical shape. The storage chamber is provided with a diaphragm 18 at one end and a movable sealed storage piston inserted from the other end. The diaphragm and piston enclose the liquid. A conduit 22 is arranged between the pressure chamber and the storage chamber. The catheter is preferably -13- This paper size applies to the Chinese National Standard (CNS) A4 specification (210 X 297 mm) 514539 A7 _ B7 V. Description of the invention (11) (Please read the precautions on the back before filling this page) It is an integral part of the pressure chamber and is provided with a needle member 23 having a channel connected to the catheter. The needle can penetrate the diaphragm 1 8 of the storage chamber to establish a fluid connection between the storage tube 8 and the pressure tube 4. This device also includes a dose administration unit 24, a pressurizing mechanism 26 'and a control unit 28. The dose administration unit may apply a force on a storage piston inside the storage chamber to transfer a predetermined volume of liquid from the storage chamber to the pressure tube via a catheter. The volume transferred depends on the distance d moved by the storage piston. The dashed line shows the position of the storage piston when a dose has been delivered. The pressurizing mechanism is configured to apply a force on a pressure piston in the pressure bobbin to generate a liquid pressure. The pressure mechanism is configured to apply a force directly or indirectly on the piston. This mechanism is only shown schematically in the figure and may be, for example, a spring loader as disclosed in U.S. Patent No. 4'4 4 7, 2 2 5. Another principle is based on the injection force generated by the gas under pressure. These two principles are known in this technical field. The pressure inside the pressure chamber during the injection is on the order of 4000 psi (pounds per square inch). Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs When a dose has been transferred into the pressure tube, the information related to the transferred volume is applied from the liquid transfer unit to the control unit 28. The control unit controls the pressurizing mechanism to first move the pressure piston in the pressure cylinder from the loading position (Fig. 2A) to the sealing position (Fig. 2B). This movement is related to volume 'so that when the pressure piston 12 is in the sealed position, substantially all the air is discharged from the pressure tube through the front end opening. After that, the pressurizing mechanism generates the necessary force to pass the liquid through the front opening when required. -14- This paper size applies Chinese National Standard (CNS) A4 (210 X 297 mm) 514539 Α7 Β7 V. Description of the invention (12) Discharge. This is shown here as the forward movement of the plunger 17 relative to the pressurizing mechanism 26. Figures 2C and 2D show slightly different layouts of the rear control sections. Similar designs. The dosing unit 24 is equipped with a dose setting button 2 5 ′ and the rotation and / or axial displacement of the button 2 5 can be converted into a pusher 1 for storing the piston 20 using any known configuration such as a screw and nut configuration. The forward movement of 9 is used to administer a liquid dose through the catheter 2 2 and inside the pressure chamber 2. Figure 2C shows the device after this dose delivery has occurred but before degassing. Figure 2D shows the device after degassing. Between FIG. 2C and FIG. 2D, the pressurizing mechanism 26 has been moved forward with respect to the pressure chamber 2 and also with respect to the box containing the dose-administering unit 24 and the control unit 28. It can be seen from the different positions of the connecting portion 2 9 ', but the plunger 17 尙 does not move forward with respect to the pressurizing mechanism 26. The control mechanism is configured to give a larger forward displacement to the pressurizing mechanism when the button 25 has a smaller dose transfer movement, and vice versa, so that the degassing of the pressurizing mechanism 26 is moved forward and transmitted to the pressure chamber The dose volumes of 2 are complementary. After degassing, the pressurization mechanism can be triggered to perform the injection. The axial movement ability of the pressurizing mechanism under the fixed position of the plunger facilitates the design of this part, such as using springs and triggers, because it does not need to contain any degassing configuration. The pressure chamber, the piston inside the pressure barrel, and at least a portion of the conduit are configured as a separate unit, which is preferably disposable. The storage chamber, the pressurizing mechanism, the dose administration unit, and the control device are arranged in a casing. The separate unit and the housing have corresponding assembly parts, which allow the unit to apply the Chinese National Standard (CNS) A4 specification (210 X 297 mm) at this paper size. Please read the notes on the back first
頁 經濟部智慧財產局員工消費合作社印製 -15- 514539 A7 _____· B7 五、發明說明(13 ) 容許儲存室與壓力室之間有經由導管的流體連接並且容許 加壓機構作用在活塞上的位置可釋放地附著於殻體。 (請先閱讀背面之注意事項再填寫本頁) 圖3 A至3 E顯示根據本發明的第二實施例的注射器 裝置。 圖3 A至3 E顯示壓力室2的剖面圖,其中壓力室2 包含一壓力筒管4,其設置有前端開口 6以及配置在筒管 內部的活塞1 2。壓力室另外包含具有連接於一針件3 4 的中心槽道3 2的一活塞桿3 0,以及一後方支座3 6。 一'芳通部份3 8另外設置在壓力筒管的內表面處於活塞位 於其裝入位置的位置處。具有膜片1 8的儲存室1 6的一 部份也顯示在圖3 A中。一衝柱4 0 (圖中顯示一部份) 經濟部智慧財產局員工消費合作社印製 與加壓機構(未顯示)機械連接,並且可將由加壓機構產 生的力經由支座3 6及活塞桿3 0而送至活塞1 2。衝柱 可相對於儲存.室自由移動。支座3 6較佳地在活塞桿的近 端部份處包含若干(例如3到5個)支撐臂。支座將針件 定位在壓力室的中心位置,並且在針件穿透儲存室的膜片 時,確保針件位於穩定的位置。當衝柱4 0於遠端方向移 動活塞桿及活塞時,支座也成爲衝柱4 0的支座。 旁通部份3 8可用許多不同的方式配置。根據一較佳 實施例,若干液體路跡或槽道可設置於壓力筒管的內表面 。根據另一實施例,內表面設置有當活塞通過時使活塞變 形的機構,因而確保液體可經過活塞。熟習此項技術者可 知有許多其他的方式可用來配置旁通部份。 圖4 A及4 B顯示旁通部份的另一實施例的剖面圖。 -16- 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) 經濟部智慧財產局員工消費合作社印製 514539 A7 -—-- B7 五、發明說明(14 ) 根據此實施例,活塞1 2設置有若干槽道1 3 ,例如1到 4個。在程序的裝入步驟中,槽道提供與活塞桿3 0的中 心槽道3 2之間的流體連接。在密封步驟中,活塞桿3 0 與活塞流體緊密連接,因而密封槽道1 3 (圖4 B )。 圖3 A顯示此方法的裝入步驟。預定劑量的液體醫藥 藉著劑量給予單元(未顯示)而從儲存室被排出。包含壓 力室’液體導管,活塞,及活塞桿的分開單元配置成與殼 體(未顯示)連接。活塞桿的上方部份設置有一密封構件 4 2 ’其在裝入位置時接合壓力筒管的內表面,以對液體 導管達成流體緊密連接。針件被插入通過膜片1 8而至儲 存室內。劑量從儲存室傳遞通過針件及活塞桿的中心槽道 ,並且在活塞桿的遠端部份與旁通部份3 8之間的空間中 經過活塞而至壓力筒管4內。 當預定體積已經傳遞至壓力筒管內時,控制裝置(未 顯示)從劑量給予單元接收與傳遞的體積有關的資訊,並 且啓動第二步驟,亦即密封步驟,其中活塞從裝入位置移 動至密封位置。圖3 B顯示此步驟的開始。衝柱4 0於遠 端方向對活塞桿施力。密封構件離開活塞桿,並且維持與 壓力室的內表面接合成爲流體緊密密封。活塞桿與活塞接 觸,此封閉液體導管,並且使活塞可推動。 在圖3 C中,活塞1 2已經被經由活塞桿3 0來對活 塞施力的衝柱移動一段預定距離而至密封位置。活塞移動 的預定距離與傳遞至壓力筒管內的劑量的體積有關,使得 大致上所有的空氣均經由前端開口 6而被排出,並且活塞 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐)Printed by the Consumers ’Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs -15- 514539 A7 _____ · B7 V. Description of the Invention (13) The fluid connection between the storage chamber and the pressure chamber via a conduit is allowed and the pressure mechanism is allowed to act on the piston The position is releasably attached to the housing. (Please read the precautions on the back before filling out this page) Figures 3 A to 3 E show a syringe device according to a second embodiment of the present invention. 3A to 3E show cross-sectional views of the pressure chamber 2, which includes a pressure tube 4 provided with a front end opening 6 and a piston 12 disposed inside the tube. The pressure chamber further includes a piston rod 30 having a central channel 32 connected to a needle member 3 4, and a rear support 36. A 'Fangtong portion 3 8 is additionally provided at the position where the inner surface of the pressure cylinder is located at the position where the piston is positioned. A part of the storage chamber 16 with the diaphragm 18 is also shown in Fig. 3A. One punch 40 (the part shown in the figure) is printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs and mechanically connected to the pressurizing mechanism (not shown), and the force generated by the pressurizing mechanism can be passed through the support 36 and the piston The rod 30 is sent to the piston 12. The punch can move freely with respect to the storage chamber. The support 36 preferably contains several (for example 3 to 5) support arms at the proximal portion of the piston rod. The holder positions the needle in the center of the pressure chamber and ensures that the needle is in a stable position when the needle penetrates the diaphragm in the storage chamber. When the plunger 40 moves the piston rod and the piston in the distal direction, the support also becomes the support of the punch 40. The bypass section 38 can be configured in many different ways. According to a preferred embodiment, a number of liquid tracks or channels may be provided on the inner surface of the pressure tube. According to another embodiment, the inner surface is provided with a mechanism that deforms the piston when it passes, thereby ensuring that liquid can pass through the piston. Those skilled in the art will know that there are many other ways to configure the bypass section. 4A and 4B are sectional views showing another embodiment of the bypass portion. -16- This paper size is in accordance with Chinese National Standard (CNS) A4 (210 X 297 mm) Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs 514539 A7 ----- B7 V. Description of the invention (14) According to this embodiment The piston 12 is provided with a plurality of channels 1 3, such as 1 to 4. In the loading step of the program, the channel provides a fluid connection to the central channel 32 of the piston rod 30. In the sealing step, the piston rod 30 is tightly connected to the piston fluid, thereby sealing the channel 13 (Fig. 4B). Figure 3 A shows the loading steps of this method. A predetermined dose of liquid medicine is discharged from the storage chamber by a dose administration unit (not shown). A separate unit containing a pressure chamber 'liquid conduit, a piston, and a piston rod is configured to be connected to a casing (not shown). A sealing member 4 2 ′ is provided at the upper portion of the piston rod, and engages the inner surface of the pressure tube when in the loading position to achieve a fluid tight connection to the liquid conduit. The needle is inserted through the diaphragm 18 into the storage chamber. The dose is transferred from the storage chamber through the needle and the central channel of the piston rod, and passes through the piston in the space between the distal end portion of the piston rod and the bypass portion 38 into the pressure barrel 4. When the predetermined volume has been transferred into the pressure tube, the control device (not shown) receives information about the transferred volume from the dose administration unit and initiates a second step, a sealing step, in which the piston moves from the loading position to Sealed position. Figure 3B shows the beginning of this step. The punch 40 applies force to the piston rod in the distal direction. The seal member leaves the piston rod and maintains engagement with the inner surface of the pressure chamber to form a fluid tight seal. The piston rod is in contact with the piston, which closes the liquid conduit and makes the piston pushable. In Fig. 3C, the piston 12 has been moved by a predetermined distance by a piston rod 30 to apply pressure to the piston to a sealed position. The predetermined distance that the piston moves is related to the volume of the dose transferred into the pressure tube, so that almost all the air is discharged through the front end opening 6, and the paper size of the piston applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm)
—訂---------線-jn^· (請先閱讀背面之注意事項再填寫本頁) 514539 A7 _ B7 五、發明說明(15 ) (請先閱讀背面之注意事項再填寫本頁) 已經移動經過旁通部份3 8。在活塞桿3 0的向前移動期 間’針件3 4從相對於壓力室2配置成固定不動的儲存室 被抽回。此時注射器裝置已經準備好來實施注射。 圖3 D顯示射出步驟的結束。一力由衝柱4 0經由活 塞桿3 〇而施加於活塞來迫使活塞於遠端方向移動,因而 經由前端開口射出液體醫藥成爲液體噴射流。在活塞桿的 此最後向前移動期間,針件3 4從儲存室2被完全抽回且 從密封膜片1 8抽出。 在圖3 E中,衝柱4 0從活塞桿的支座抽回,並且分 開單元(包含壓力室,壓力筒管,活塞,及具有針件的活 塞桿)可從殼體釋放(例如旋開螺釘)且被丟棄。當分開 單元要被釋放時,針件由壓力室良好地保護。 經濟部智慧財產局員工消費合作社印製 一重要的細節爲活塞可相對於活塞桿自由地移動。此 表示活塞桿不能於近端方向將活塞拉回至開始位置,此使 得裝置的重新被使用幾乎完全不可能。必須避免重新使用 的原因自然是由於將污染或傳染疾病的危險減至最小的重 要性。此配置的另一有利處在於活塞與活塞桿之間沒有任 何與所述的可丟棄式部份的更換有關的附著或脫離。此特 徵的成爲可能部份是由於本發明不須藉著活塞的退回來將 液體抽取或吸入至壓力室內,而是液體可被正向地注射至 壓力室內,因爲除氣可在稍後實施。 儲存室可爲儲存液體醫藥的單一容室。其也可爲設置 有一旁通部份(或多個旁通部份)的二隔間(或多隔間) 容室,以在注射之前預備液體。 -18- 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) 514539 A7 B7 五、發明說明(16 ) 可設置不同的儲存室來容納不同濃度的液體醫藥。使 用小劑量體積很有利,因爲與注射較大體積相比,注射較 小體積比較不痛。如果使用較小的注射體積,則液體醫藥 中活性物質的濃度必須較高。 在本發明的整個敘述中,由裝置所產生的高壓噴射流 被安排成爲穿透病人的皮膚。但是,本發明的基本原理可 相等地應用在實施具有高黏性的液體醫藥例如凝膠的針注 射時。目前,如果要藉由針式注射器來注射例如凝膠,則 必須使用具有相較而言大內徑的針,而此可能非常疼痛。 根據本發明的另一實施例,一皮下注射針附著成與注射器 裝置的前端開口連接。此連接是以非常強固的方式來實施 ,以耐注射期間壓力室內部的壓力。皮下注射針較佳地是 在壓力室的製造期間例如模製過程期間附著於壓力室。注 射程序與在實施如上所述的無針噴射注射時相同。藉著使 用設置有具有類似於壓力室的前端開口的內徑的針的壓力 室,可使用與習知者相比較細的針來注射具有高黏性的液 體。此非常有利,因爲使病人較不疼痛。實施根據此另一 實施例的針注射所需的必要壓力除其他因素外是與針的內 徑及液體凝膠的黏性有關。 壓力室中的典型最大壓力一般而言是在2 5 a t m ( 2 · 5MPa)以上,通常在 50a tm (5MPa)以 上或100a tm (l〇MPa)以上。常態下,壓力是 在l〇〇〇a tm (l〇〇MPa)以下,通常在800 a tm (80MPa)以下或 500a tm (50MPa 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) (請先閱讀背面之注意事項再填寫本頁)—Order --------- line-jn ^ · (Please read the notes on the back before filling in this page) 514539 A7 _ B7 V. Invention Description (15) (Please read the notes on the back before filling (This page) has moved past the bypass section 3 8. During the forward movement of the piston rod 30, the 'needle member 34' is withdrawn from a storage chamber which is fixedly disposed with respect to the pressure chamber 2. The syringe device is now ready to perform the injection. Figure 3D shows the end of the injection step. A force is applied to the piston by the punch 40 through the piston rod 30 to force the piston to move in the distal direction, so the liquid medicine is ejected through the front opening to become a liquid jet. During this last forward movement of the piston rod, the needle 3 4 is completely withdrawn from the storage chamber 2 and withdrawn from the sealing diaphragm 18. In FIG. 3E, the punch 40 is withdrawn from the support of the piston rod, and the separation unit (including the pressure chamber, the pressure tube, the piston, and the piston rod with a needle) can be released from the housing (for example, unscrewing Screws) and discarded. When the separation unit is to be released, the needle is well protected by the pressure chamber. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs An important detail is that the piston can move freely relative to the piston rod. This means that the piston rod cannot pull the piston back to the starting position in the proximal direction, which makes it almost impossible to reuse the device. The reason why reuse must be avoided is naturally due to the importance of minimizing the risk of contamination or infectious diseases. Another advantage of this configuration is that there is no attachment or detachment between the piston and the piston rod related to the replacement of the disposable part described. This feature is made possible in part because the present invention does not require the liquid to be drawn or sucked into the pressure chamber by the withdrawal of the piston, but the liquid can be injected into the pressure chamber in a forward direction, because degassing can be performed later. The storage chamber may be a single storage chamber for storing liquid medicine. It may also be a two-compartment (or multi-compartment) container provided with a bypass section (or multiple bypass sections) to prepare the liquid before injection. -18- This paper size is in accordance with Chinese National Standard (CNS) A4 (210 X 297 mm) 514539 A7 B7 5. Description of the invention (16) Different storage chambers can be set up to accommodate liquid medicines of different concentrations. It is advantageous to use a small dose volume because a smaller volume is less painful than a larger volume. If a smaller injection volume is used, the concentration of the active substance in the liquid medicine must be higher. Throughout the description of the invention, the high-pressure jet generated by the device is arranged to penetrate the skin of a patient. However, the basic principle of the present invention can be equally applied to the needle injection of a liquid medicine having a high viscosity such as a gel. Currently, if a gel syringe is to be used for injection, such as a gel, a needle having a relatively large inner diameter must be used, which can be very painful. According to another embodiment of the present invention, a hypodermic needle is attached to the front opening of the syringe device. This connection is implemented in a very strong way to withstand the pressure inside the pressure chamber during the injection. The hypodermic needle is preferably attached to the pressure chamber during manufacture of the pressure chamber, such as during a molding process. The injection procedure is the same as when performing needleless injection injection as described above. By using a pressure chamber provided with a needle having an inner diameter similar to that of the front end of the pressure chamber, a needle having a thinner diameter than that of a conventional person can be used to inject a liquid having high viscosity. This is very advantageous because it makes the patient less painful. The necessary pressure required to perform a needle injection according to this other embodiment is related to, among other factors, the inside diameter of the needle and the viscosity of the liquid gel. The typical maximum pressure in the pressure chamber is generally above 25 a tm (2.5 MPa), usually above 50 a tm (5 MPa) or above 100 a tm (10 MPa). Under normal conditions, the pressure is below 1000 a tm (100 MPa), usually below 800 a tm (80 MPa) or 500 a tm (50 MPa). This paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 Mm) (Please read the notes on the back before filling out this page)
經濟部智慧財產局員工消費合作社印製 -19- 514539 A7 B7___ 五、發明說明(17 ) )以下。 4 (請先閱讀背面之注意事項再填寫本頁) 圖5顯示根據本發明的多劑注射器裝置。此裝置包含 具有指示劑量的大小的指示器5 3的殼體5 1 ,用來調整 劑量大小的調整控制器5 5,用來預備注射的機構5 7 ( 控制劑量給予單元及加壓機構),控制加壓機構以產生注 射所需的例的釋放扳機5 9 ,指示窗口 6 1 ,以及分開單 元6 3。 圖6顯示在具有可移去膜6 6的圍封覆蓋6 5中以保 持無菌的分開單元6 3。分開單元6 3可在要實施注射時 可釋放地附著於殼體。螺紋6 7設置在分開單元處,並且 相應的螺紋配置在殼體的遠末端的內表面上。單元6 3在 使用後被旋鬆且丟棄。 經濟部智慧財產局員工消費合作社印製 圖7 A至7 E顯示可與此處相應於圖中的前方部份的 圖3的裝置實施例一起使用的用於劑量設定,除氣,以及 注射的機構。圖中所示的以7 0 0槪括標示的裝置可被視 爲包含一可丟棄部份7 0 1以及含有上述機構及儲存室的 一可重新使用部份7 0 2。以與圖3中相同的參考數字, 可丟棄部份7 0 1包含具有壓力筒管4,活塞1 2,及開 口 6的壓力室2 ,以及具有中心槽道3 2的活塞桿3 0, 後方針件3 4,以及支座3 6。可重新使用部份7 0 2可 被視爲包含容納儲存室7 2 0及會進一步敘述的上述機構 的殼體7 1 0。殼體7 1 0具有用來與可丟棄部份7 〇 1 上的外螺紋嚙合的前方內螺紋7 1 1 ,以容許移去用過的 可丟棄部份並且附著一新的可丟棄部份,而在此操作期間 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) _ _ 514539 A7 B7 五、發明說明(18 ) (請先閱讀背面之注意事項再填寫本頁) 經濟部智慧財產局員工消費合作社印製 ,針件3 4穿透儲存室膜片。此處顯示成爲具有瓶頸前方 部份的儲存室7 2 0包含穿透膜片7 2 2,儲存活塞 7 2 4,以及開口後端7 2 6。上述機構可被視爲包含可 在圖7 F中較佳地看見的一注射單元7 3 0,其包含環繞 儲存室7 2 0的一衝柱7 3 1 ,其具有配置來與活塞桿支 座3 6進行推動合作的一前方凸緣7 3 2,以及被彈簧 7 3 6影響的一後方凸緣7 3 3。衝柱可伸縮地配置於具 有用於彈簧7 3 6的支撐凸緣7 3 5的一環繞衝柱支座 7 3 4。衝柱可相對於衝柱支座軸向移動,並且彈簧被偏 壓成以充分的力來使衝柱以及活塞桿3 0向前推進,以產 生注射所需的壓力。扳機鈕7 3 7示意地顯示,並且被配 置來在常態下將衝柱7 3 1與衝柱支座7 3 4相對於彼此 鎖定,但是當其被推動時,則容許衝柱在彈簧的作用下向 前移動。注射單元7 3 0整個可軸向移動地配置在殼體 7 1 0中,以容許在注射觸發之前在除氣步驟中向前移動 ,並且殼體具有用來在注射單元7 3 0的此軸向移動期間 容納外部可接近的扳機7 3 7的狹縫7 1 2。上述機構可 被視爲另外包含一除氣單元7 4 0,其被配置來在除氣步 驟期間使注射單元7 3 0向前移動,因而也使活塞桿3 0 向前移動。除氣單元7 4 0包含一軸向可移動的轉移元件 7 4 1 ,其具有用來在推動注射單元向前時與衝柱支撐凸 緣7 3 5合作的前端7 4 2,及用來與稍後會敘述的推桿 合作的後方推動凸緣7 4 3 ,以及一中心孔7 4 4,其容 許可繞稍後會敘述的控制鼓件自由地軸向通過。上述機構 -21 - 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) 514539 A7 B7 五、發明說明(19 ) (請先閱讀背面之注意事項再填寫本頁) 也可被視爲包含一液體傳遞單元7 5 0,其被配置來使儲 存活塞7 2 4移位,以進行從儲存室7 2 0經由針件3 4 ,中心槽道3 2,以及旁通部份3 8至壓力室2內的液體 傳遞,如相關於圖3所述者。液體傳遞單元7 5 0包含一 旋轉地配置的螺紋柱塞7 5 1 ,其與相對於殼體於軸向及 旋轉方向固定不動的有相應螺紋的螺母7 5 2合作,使得 柱塞的旋轉造成柱塞軸向移動。柱塞的後方部份在非旋轉 式的連接(未顯示)例如非圓形連接下插入稍後會敘述的 控制鼓件中且與其合作,使得鼓件的旋轉造成柱塞的旋轉 ,並且在單向連接(未顯示)例如棘爪與棘輪配置下插入 稍後會敘述的控制鼓件中且與其合作,使得柱塞只會於一 方向旋轉來使其軸向向前移動。上述機構也可被視爲包含 一控制單元7 6 0,其被配置來依序確保預設的劑量體積 從儲存室傳遞.至壓力室,以及隨後的壓力室中剩餘體積的 除氣。控制單元對不同的設定劑量確保這些作用,亦即對 於小劑量有較長的除氣行程,而對於大劑量體積有較短的 除氣行程。控制單元可被視爲包含一鼓件7 6 1 ,其被配 經濟部智慧財產局員工消費合作社印製 置爲軸向固定不動,但是可相對於殼體旋轉。除了已經敘 述的與柱塞7 5 1合作的鼓件特徵之外,鼓件包含一軌道 7 6 2,其具有螺旋延伸部份7 6 3,膝部7 6 4,以及 軸向筆直延伸部份7 6 5。膝部7 6 4的軸向位置大約在 轉移元件7 4 1的後方推動凸緣7 4 3在除氣步驟之前所 在的位置處。控制單元另外包含推桿7 6 6 ,其被配置成 爲可相對於殼體軸向移動及旋轉,且其具有被配置成與鼓 -22- 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) 經濟部智慧財產局員工消費合作社印製 514539 A7 __ B7 五、發明說明(20 ) 件7 6 1的軌道7 6 2合作的軌道從動件7 6 7 ’與轉移 元件7 4 1合作的表面7 6 8,以及與稍後會敘述的劑量 設定單元的相應螺紋部份合作的後方螺紋7 6 9 ’並且在 其外表面上有外部螺旋栓槽(未顯示)。當推桿7 6 6從 如圖7 A所示的位置向前移動時並且被鎖定而不能旋轉時 ,與軌道的螺旋延伸部份7 6 3合作的從動件7 6 7會首 先使鼓件旋轉,因而旋轉柱塞7 5 1 ’以使其向前移動來 用已經敘述的機構將液體從儲存室傳遞至壓力室。當從動 件到達軌道膝部7 6 4時,不再發生任何的鼓件旋轉,並 且液體的傳遞終止。在膝部處,從動件表面7 6 8也接合 轉移元件7 4 1 ,並且推桿在除氣步驟中的進一步向前移 動會使轉移元件及注射單元7 3 0向前。推桿被配置成爲 對於每一注射循環實施相同的向前行程長度,而與從動件 在軌道的螺旋部份的開始位置無關。在軌道的螺旋部份中 的較長移動會造成在軌道的筆直部份中的較短移動,反之 亦然,因而使劑量傳遞與除氣移動之間有想要的關係。最 後,上述機構可被視爲包含用於劑量設定及推桿移動的致 動單元7 7 0。致動單元包含一手動控制旋鈕7 7 1 ,其 可被旋轉來實施劑量設定,並且可被推動來實施劑量傳遞 及除氣。旋鈕具有配置成與推桿7 6 6的螺紋部份合作的 螺釘7 7 2。旋鈕的旋轉會將推桿移動至相應於所想要的 劑量體積的可選擇的初始軸向位置。在此劑量設定步驟下 ,推桿7 6 6可與從動件7 6 7 —起在軌道的螺旋部份 7 6 3中旋轉,以防止任何的旋轉施加於控制鼓件7 6 1 ---— l·--I ^---------^ (請先閱讀背面之注意事項再填寫本頁) 1-1- 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) -23- 514539 A7 ___Bl 五、發明說明(21 ) (請先閱讀背面之注意事項再填寫本頁) 。此係由一內部旋鈕套筒7 7 4來控制,此套筒7 7 4相 對於旋鈕7 7 1軸向固定但是可旋轉,且例如藉著使用筆 直栓槽而相對於殼體可軸向移動但是不能旋轉,並且其具 有與推桿表面上的外部螺旋栓槽合作的外部螺旋栓槽(未 顯示),此螺旋栓槽具有相應於軌道7 6 2的螺旋部份 7 6 3的節距的節距’並且此二節距均非自我鎖定,而後 方螺紋7 6 9的節距爲自我鎖定。在劑量設定之後,推桿 相對於旋鈕7 7 1及旋鈕套筒7 7 4軸向固定。推動旋鈕 會使推桿7 6 6向前移動來實施所述的作用。回動彈簧 7 7 3被配置來將S疋紐朝向其後方位置偏壓,此會在鼓件 移動模式的反向之下使旋鈕回至其後方位置,但是此由於 所述的單向配置將不會使柱塞7 5 1向後移動,因而沒有 任何的力作用來使活塞3 2向後移動。旋鈕的行程長度應 相應於活塞1 2在壓力筒管4中的最大行程長度,如圖7 A中以箭頭L所示者。軌道7 6 2的筆直延伸部份7 6 5 也應較佳地至少具有相同的長度,相應於最小劑量以及壓 力室中的最大除氣距離。 經濟部智慧財產局員工消費合作社印製 圖7 A顯示在尙未傳遞任何液體之前但是可能在劑量 設定作用已經將從動件7 6 7帶至軌道的螺旋部份7 6 3 的中間位置之後的裝置。在圖7 B中,旋鈕7 7 1已經部 份被壓至相應於完整地傳遞選定的劑量體積的位置。此推 動的發生是較佳地藉著握持裝置殼體且如圖所示地將其朝 向一支座壓,並且較佳地使裝置位於直立位置,以將所傳 遞的劑量保持在壓力筒管4的後方部份。圖中所示的液體 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) -24- M4539 A7 B7 五、發明說明(22 ) 问度爲D ’空氣高度爲L 一 D,亦即旋鈕7 7 1的剩餘行 長度。當推桿7 6 6在所示的位置時,從動件7 6 7已 經到達軌道的筆直部份7 6 5,並且已經與轉移元件 7 4 1接合。鼓件7 6 1已經被旋轉(可以看見螺旋延伸 部份7 6 3的下方部份)而使柱塞7 5 1及儲存活塞 7 2 4向前。在圖7 C中,旋鈕7 7 1已經完全被壓過剩 餘的距離L - D,相應於壓力室2的完全除氣。在此移動 期間,推桿7 6 6已經使轉移元件7 4 1,具有衝柱 731的注射單元730,活塞桿30,以及活塞12向 前移位相應的距離,以在壓力室2中爲活塞1 2留下爲D 的剩餘行進距離。扳機7 3 7已經在狹縫7 1 2中向前移 動。在同一移動期間,鼓件7 6 1停擺而不旋轉,因爲從 動件已經在軌道7 6 2的筆直部份7 6 5中行進。針件 3 4已經移動離開儲存室,如相關於圖3更完全地敘述者 。在圖7 D中,旋鈕7 7 1已經被釋放,並且回動彈簧 7 7 3已經將其帶回至其伸出位置。此也使推桿7 6 6及 鼓件7 6 1的移動反向,二者此時回至其初始位置,但是 柱塞7 5 1及儲存活塞7 2 4由於所設置的單向配置而不 受影響。在圖7 E中,扳機7 3 7已經被啓動來從衝柱支 座7 3 4釋放衝柱7 3 1,容許彈簧2 3 6來迫使衝柱 了 3 1 ,活塞桿3 0,以及活塞1 2行進剩餘距離D至其 最後的向前位置。在所示的實施例中,衝柱支座7 3 4及 轉移元件2 4 1可在彈簧2 3 6的影響下向後移動至其初 始位置,但是也可例如藉著閂鎖配置或諸如棘爪及棘輪軌 (請先閱讀背面之注意事項再填寫本頁) illl· —--訂·! - - ----線· 經濟部智慧財產局員工消費合作社印製 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公髮1 . 25 .~一 514539 A7 __ B7 五、發明說明(23 ) 條的單向配置來防止此一轉.回移動。此時完成注射,並且 可丟棄部份7 0 1可從可重新使用部份7 0 2旋鬆’重新 準備注射單元,以及附著新的可丟棄部份7 0 1來重複上 述循環。 所述的裝置顯示將除氣機構與加壓機構串聯配置且配 置在加壓機構的後方的較佳實施例,使得其藉著將加壓機 構向前移動來移動壓力活塞。可以有數種另外的選擇。除 氣機構可仍然串聯配置,但是配置在壓力室與加壓機構之 間,並且可藉著抵靠固定不動的加壓機構伸長而向前移動 ,或是與加壓機構一起移動。除氣機構也可與加壓機構並 聯配置,以彼此完全無關地作動,在此情況中加壓機構可 維持固定不動,或是可被除氣機構向前拖動。在所有的另 外選擇中,除氣機構可藉著伸長或藉著相對於殼體移動來 將壓力活塞向前移動,並且此移動可藉著包含釋放儲存的 能量的致動機構或是藉著手動的影響來發生。 經濟部智慧財產局員工消費合作社印製 與本發明一起使用的壓力室較佳地在組裝之前被消毒 ,並且被淨空或是充塡有空氣或氣體。其較佳地爲可丟棄 式,但是也可以是可重新使用的。前端開口的內徑爲 0 · 1至0 · 6 mm (毫米),以在〇· 15mm的數量 級較佳。如上所述,開口可用於如圖所示的無針噴射注射 ,或是針注射,在後一情況中前端開口可具有供針用的附 著件或連接器。如也是已知的,可使用在大約1至3 m m 的範圍的短針來穿透皮膚的最外部部份,因而減小到達組 織中目標深度所需的噴射速率。 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公楚1 . 26 - 514539 A7 -- B7 五、發明說明(24 ) (請先閱讀背面之注意事項再填寫本頁) 儲存室較佳地與壓力室分開,並且較佳地由不同的材 料製成。根據較佳實施例,儲存室是由例如型I ( Type I )玻璃的玻璃製成,而壓力室是由例如聚碳酸酯的塑膠製 成。 根據另一實施例,儲存室藉著一中間活塞且設置有一 旁通部份而分成二分開的隔室,其中後方隔室包含例如水 的液體,而前方隔室包含例如親液性化的粉末的固體組份 。液體經由旁通部份而被迫入遠端隔室內,而在其中液體 溶解固體組份。此在二隔室注射器的技術領域中爲已知的 程序。然後,位在遠端隔室中的如此混合的液體以與以上 所述者完全相同的方式傳遞至壓力室內。 經濟部智慧財產局員工消費合作社印製 用在壓力室或雙隔室儲存室中的旁通設計可採取多種 不同的形式。圖中所示的旁通部份大略包含在壓力室的旁 通部份的內表面上的一或多個路跡或旁通槽道。旁通槽道 可與輸送室的縱向平行,例如美國專利第5,501,673號中所 述者。旁通槽道也可對縱向成角度配置,例如美國專利第 5,7 1 6,3 3 8號中所述者。槽道的數目是根據被傳 遞的液體量來選擇,以在1至1 5的數量級較佳。習知技 術中已知有許多另外的不同的配置旁通部份的方式。重要 的是鑑於當液體被傳遞時存留在槽道中的液體體積,因此 不要配置太多的槽道。也宜於減少保持在活塞上的任何圓 周脊之間的死體積,此可藉著將通過脊與通過活塞的主體 的內徑之間的差異保持於小的値。根據另一實施例,旁通 部份的內表面的形狀係成爲使得活塞在經過旁通部份時變 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) 514539 A7 --- B7 五、發明說明(25 ) 形’因而容許液體從儲存室通過至壓力室內,例如美國專 利第5 ’ 472 ’ 422號及第5 ,817 ,〇55號中 (請先閱讀背面之注意事項再填寫本頁) 所述者。 所實施的不同步驟基本上爲三步驟程序,包含液體從 儲存室傳遞至壓力室內的傳遞步驟,用來從壓力室去除空 氣的步驟,以及注射步驟。與加壓步驟相比,液體傳遞步 驟及除氣步驟較佳地相當緩慢地且在低壓力下實施,以不 引發玻璃的破裂,柱塞在旁通部份中的過衝,液體的起泡 ’或是液體經由開口噴灑。只有注射步驟必須在高壓力下 實施。 在傳遞步驟期間以及在空氣去除步驟期間,裝置較佳 地被保持於幾近直立的位置,亦即壓力室的前端開口在水 平線上方,傾斜,或是大致朝上,以防止液體傾出。 本發明不.受限於上述的較佳實施例。可使用各種不同 的選擇,修正,及等效物。因此,上述的實施例不應被視 爲是限制由附隨的申請專利範圍所界定的本發明的範圍。 經濟部智慧財產局員工消費合作社印製 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) _ 28 -Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs -19- 514539 A7 B7___ V. Description of Invention (17)) below. 4 (Please read the notes on the back before filling out this page) Figure 5 shows a multi-dose syringe device according to the present invention. This device includes a housing 5 1 with an indicator 5 3 indicating the size of the dose, an adjustment controller 5 5 for adjusting the dose, a mechanism 5 7 for preparing an injection (controlling the dose administration unit and the pressurizing mechanism), The pressurizing mechanism is controlled to generate a release trigger 5 9 required for injection, an instruction window 6 1, and a separation unit 63. Figure 6 shows a separate unit 63 in an enclosure cover 65 with a removable membrane 6 6 to maintain sterility. The separation unit 63 can be releasably attached to the case when an injection is to be performed. Threads 67 are provided at the separation unit, and corresponding threads are arranged on the inner surface of the distal end of the housing. Unit 63 is unscrewed and discarded after use. Figures 7 A to 7 E printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs show the use of the device embodiment of Figure 3 corresponding to the front part of the figure for dose setting, degassing, and injection. mechanism. The device shown in the figure, shown in brackets 700, can be regarded as containing a disposable portion 701 and a reusable portion 702 containing the above-mentioned mechanism and storage room. With the same reference numerals as in FIG. 3, the disposable part 7 0 1 includes a pressure chamber 2 having a pressure cylinder 4, a piston 12 and an opening 6, and a piston rod 3 0 having a central channel 32, and Guide pieces 3 4 and supports 3 6. The reusable portion 7 0 2 can be regarded as a housing 7 1 0 containing a storage chamber 7 2 0 and the above-mentioned mechanism which will be described further. The housing 7 1 0 has a front internal thread 7 1 1 for engaging with the external thread on the disposable part 7 〇1 to allow the used disposable part to be removed and a new disposable part to be attached, And during this operation, the paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) _ 514539 A7 B7 V. Description of the invention (18) (Please read the precautions on the back before filling this page) Economy Printed by the Consumer Cooperative of the Ministry of Intellectual Property Bureau, the needles 3 and 4 penetrate the diaphragm of the storage room. It is shown here that the storage chamber 7 2 0 which has the front part of the bottleneck contains a penetrating diaphragm 7 2 2, a storage piston 7 2 4, and an open rear end 7 2 6. The above-mentioned mechanism can be regarded as including an injection unit 7 3 0 which is better seen in FIG. 7 F, which includes a punch 7 3 1 surrounding the storage chamber 7 2 0 and which is configured to communicate with the piston rod support. A front flange 7 3 2 for pushing cooperation and a rear flange 7 3 3 affected by the spring 7 3 6. The punch is telescopically arranged on a surrounding punch support 7 3 4 having a support flange 7 3 5 for a spring 7 3 6. The plunger can move axially relative to the plunger support, and the spring is biased to push the plunger and piston rod 30 forward with sufficient force to generate the pressure required for injection. The trigger button 7 3 7 is shown schematically and is configured to lock the punch 7 3 1 and the punch holder 7 3 4 relative to each other in the normal state, but when it is pushed, the punch is allowed to act on the spring Move forward. The injection unit 7 3 0 is disposed in the housing 7 1 0 so as to be axially movable in total to allow it to move forward in the degassing step before the injection is triggered, and the housing has this shaft for the injection unit 7 3 0 The slot 7 1 2 which accommodates an externally accessible trigger 7 3 7 during the upward movement. The above mechanism can be regarded as additionally including a degassing unit 7 40 configured to move the injection unit 7 30 forward during the degassing step, thereby also moving the piston rod 30 forward. The degassing unit 7 4 0 includes an axially movable transfer element 7 4 1 having a front end 7 4 2 for cooperating with the punch support flange 7 3 5 when pushing the injection unit forward, and for A rear push flange 7 4 3, which will be described later, cooperates with a push rod, and a central hole 7 4 4, which allows free axial passage around a control drum member which will be described later. The above agencies-21-This paper size is in accordance with Chinese National Standard (CNS) A4 (210 X 297 mm) 514539 A7 B7 V. Description of the invention (19) (Please read the notes on the back before filling this page) It can also be used Considered to include a liquid transfer unit 7 50 configured to displace the storage piston 7 2 4 for passage from the storage chamber 7 2 0 through the needle member 3 4, the central channel 32, and the bypass portion 3 8 to the liquid transfer in the pressure chamber 2 as described in relation to FIG. 3. The liquid transfer unit 7 50 includes a threaded plunger 7 5 1 that is rotatably arranged and cooperates with a nut 7 5 2 with a corresponding thread that is fixed relative to the housing in the axial direction and the rotation direction, so that the rotation of the plunger causes The plunger moves axially. The rear part of the plunger is inserted into and cooperates with a control drum piece to be described later under a non-rotating connection (not shown) such as a non-circular connection, so that the rotation of the drum member causes the plunger to rotate, A directional connection (not shown), such as a pawl and ratchet arrangement, is inserted into and cooperates with a control drum member which will be described later, so that the plunger will only rotate in one direction to move its axial direction forward. The above-mentioned mechanism can also be regarded as including a control unit 760, which is configured to sequentially ensure that a predetermined dose volume is transferred from the storage chamber to the pressure chamber and subsequent degassing of the remaining volume in the pressure chamber. The control unit ensures these effects for different set doses, ie longer degassing strokes for small doses and shorter degassing strokes for large dose volumes. The control unit can be thought of as containing a drum piece 7 6 1, which is printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs to be axially fixed but rotatable relative to the housing. In addition to the features of the drum member that have been described in cooperation with the plunger 7 51, the drum member includes a track 7 6 2 having a spiral extension 7 6 3, a knee 7 6 4 and an axially straight extension. 7 6 5. The axial position of the knees 7 6 4 is approximately at the position where the flange 7 4 3 is pushed behind the transfer element 7 4 1 before the degassing step. The control unit additionally includes a push rod 7 6 6 which is configured to be axially movable and rotatable with respect to the housing, and which has a configuration which is configured to match the drum-22- This paper size is applicable to the Chinese National Standard (CNS) A4 specification (210 X 297 mm) Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs 514539 A7 __ B7 V. Description of the invention (20) Piece 7 6 1 orbit 7 6 2 Cooperative track follower 7 6 7 'and transfer element 7 4 1 a cooperative surface 7 6 8 and a rear thread 7 6 9 ′ which cooperates with a corresponding threaded portion of a dose setting unit which will be described later and has an external spiral bolt groove (not shown) on its outer surface. When the pusher 7 6 6 moves forward from the position shown in FIG. 7A and is locked from rotation, the follower 7 6 7 cooperating with the spiral extension 7 6 3 of the track will first make the drum member Rotate, thus rotating the plunger 7 5 1 ′ to move it forward to transfer the liquid from the storage chamber to the pressure chamber by the mechanism already described. When the follower reaches the knees 7 6 4 of the track, no more drum rotation occurs and the transfer of liquid ends. At the knee, the follower surface 7 6 8 also engages the transfer element 7 4 1, and further forward movement of the push rod in the degassing step brings the transfer element and the injection unit 7 30 forward. The pusher is configured to perform the same forward stroke length for each injection cycle, regardless of the start position of the follower in the spiral portion of the track. Longer movements in the spiral portion of the orbit result in shorter movements in the straight portion of the orbit and vice versa, thus giving the desired relationship between dose delivery and outgassing movement. Finally, the above mechanism can be regarded as including an actuation unit 7 70 for dose setting and pusher movement. The actuation unit contains a manual control knob 7 7 1 which can be rotated to carry out dose setting and can be pushed to carry out dose delivery and degassing. The knob has a screw 7 7 2 configured to cooperate with a threaded portion of the push rod 7 6 6. Rotation of the knob moves the plunger to a selectable initial axial position corresponding to the desired dose volume. In this dose setting step, the pusher 7 6 6 can rotate with the follower 7 6 7 in the spiral part 7 6 3 of the track to prevent any rotation from being applied to the control drum 7 6 1 --- — L · --I ^ --------- ^ (Please read the notes on the back before filling in this page) 1-1- This paper size applies to China National Standard (CNS) A4 (210 X 297 (Mm) -23- 514539 A7 ___Bl V. Description of Invention (21) (Please read the notes on the back before filling this page). This is controlled by an internal knob sleeve 7 7 4 which is axially fixed but rotatable relative to the knob 7 7 1 and can be moved axially relative to the housing, for example by using a straight bolt groove But it ca n’t rotate, and it has an external spiral bolt groove (not shown) that cooperates with an external spiral bolt groove on the surface of the putter. This spiral bolt groove has a pitch corresponding to the spiral portion 7 6 3 of the track 7 6 2 Pitch 'and these two pitches are not self-locking, while the pitch of the rear thread 7 6 9 is self-locking. After setting the dose, the pusher is axially fixed with respect to the knob 7 7 1 and the knob sleeve 7 7 4. Pushing the knob causes the pusher 7 6 6 to move forward to perform the described effect. The return spring 7 7 3 is configured to bias the stern button towards its rear position, which will return the knob to its rear position under the reversal of the drum movement mode, but this is due to the one-way configuration The plunger 7 5 1 is not moved backward, so there is no force applied to move the piston 32 2 backward. The stroke length of the knob should correspond to the maximum stroke length of the piston 12 in the pressure barrel 4, as shown by the arrow L in Fig. 7A. The straight extension 7 6 5 of the track 7 6 2 should also preferably have at least the same length, corresponding to the minimum dose and the maximum degassing distance in the pressure chamber. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs, Figure 7A shows the position before the liquid is transferred but may be after the dose setting effect has been brought from the follower 7 6 7 to the middle position of the spiral part 7 6 3 of the orbit. Device. In Figure 7B, the knob 7 7 1 has been partially pressed to a position corresponding to the complete delivery of the selected dose volume. This pushing occurs preferably by holding the device housing and pressing it towards a seat as shown, and preferably with the device in an upright position to maintain the delivered dose at the pressure barrel The rear part of 4. The paper size shown in the figure applies to the Chinese National Standard (CNS) A4 specification (210 X 297 mm) -24- M4539 A7 B7 V. Description of the invention (22) The problem is D 'The air height is L-D, That is, the remaining line length of the knob 7 7 1. When the pusher 7 6 6 is in the position shown, the follower 7 6 7 has reached the straight part 7 6 5 of the track and has been engaged with the transfer element 7 4 1. The drum member 7 6 1 has been rotated (the lower part of the spiral extension 7 6 3 can be seen) to bring the plunger 7 5 1 and the storage piston 7 2 4 forward. In Fig. 7C, the knob 7 7 1 has been completely pressed by the excess distance L-D, which corresponds to the complete degassing of the pressure chamber 2. During this movement, the pusher 7 6 6 has caused the transfer element 7 4 1, the injection unit 730 with the punch 731, the piston rod 30, and the piston 12 to be shifted forward by a corresponding distance to be the piston in the pressure chamber 2 1 2 Remaining travel distance left as D. The trigger 7 3 7 has been moved forward in the slit 7 1 2. During the same movement, the drum member 7 6 1 stops and does not rotate, because the follower already travels in the straight portion 7 6 5 of the track 7 6 2. The needle 34 has moved away from the storage chamber, as described more fully in relation to FIG. 3. In Fig. 7D, the knob 7 7 1 has been released and the return spring 7 7 3 has brought it back to its extended position. This also reverses the movement of the push rod 7 6 6 and the drum member 7 6 1, and both return to their initial positions at this time, but the plunger 7 5 1 and the storage piston 7 2 4 are not set due to the one-way configuration. Affected. In FIG. 7E, the trigger 7 3 7 has been activated to release the punch 7 3 1 from the punch support 7 3 4, allowing the spring 2 3 6 to force the punch 3 1, the piston rod 3 0, and the piston 1 2 Travel the remaining distance D to its last forward position. In the embodiment shown, the punch support 7 3 4 and the transfer element 2 4 1 can be moved backwards to their initial position under the influence of the spring 2 3 6, but it can also be, for example, by means of a latch configuration or a detent And ratchet rails (please read the precautions on the back before filling out this page) illl · —-order ·! ------ Line · Printed by the Consumers' Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs. The paper size is applicable to the Chinese National Standard (CNS) A4 (210 X 297) 1.25. ~ 514539 A7 __ B7 V. Description of the invention (23) One-way configuration to prevent this one turn. Move back. The injection is completed at this time, and the part 7 0 1 can be unscrewed from the reusable part 7 0 2 'Re-preparing the injection unit and attaching A new disposable part 701 repeats the above cycle. The device described shows a preferred embodiment in which the degassing mechanism is arranged in series with the pressurizing mechanism and is arranged behind the pressurizing mechanism, so that it can pressurize by The mechanism moves forward to move the pressure piston. There are several alternatives. The degassing mechanism can still be arranged in series, but it is located between the pressure chamber and the pressure mechanism, and can be extended by elongating against the fixed pressure mechanism. Move forward or move with the pressurizing mechanism. The degassing mechanism can also be arranged in parallel with the pressurizing mechanism to act completely independently of each other. In this case, the pressurizing mechanism can be kept fixed or can be degassed. Institution forward Drag. In all other options, the degassing mechanism can move the pressure piston forward by elongation or by moving relative to the housing, and this movement can be by an actuating mechanism that releases stored energy or It occurs by manual influence. The pressure chamber printed with the present invention by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs is preferably sterilized before assembly, and is cleaned or filled with air or gas. It is preferred The ground is disposable, but it can also be reused. The inner diameter of the front end opening is 0 · 1 to 0 · 6 mm (mm), preferably on the order of 0.15 mm. As mentioned above, the opening can be used for Needleless injection as shown in the figure, or needle injection, in the latter case the front opening can have an attachment or connector for the needle. If it is also known, it can be used in the range of about 1 to 3 mm Short needles to penetrate the outermost part of the skin, thereby reducing the jetting rate required to reach the target depth in the tissue. This paper size applies to China National Standard (CNS) A4 (210 X 297 Gong Chu 1.26-514539 A7 -B 7 V. Description of the invention (24) (Please read the notes on the back before filling out this page) The storage chamber is preferably separated from the pressure chamber and is preferably made of different materials. According to a preferred embodiment, the storage chamber It is made of glass such as Type I glass, and the pressure chamber is made of plastic such as polycarbonate. According to another embodiment, the storage chamber is provided by a middle piston and provided with a bypass portion. Divided into two separate compartments, where the rear compartment contains a liquid such as water, and the front compartment contains a solid component such as a lyophilic powder. The liquid is forced into the distal compartment via the bypass portion, and The liquid dissolves the solid components therein. This is a known procedure in the technical field of two-compartment syringes. The liquid thus mixed in the distal compartment is then transferred into the pressure chamber in exactly the same manner as described above. Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economics. Bypass designs used in pressure rooms or double compartment storage rooms can take many different forms. The bypass portion shown in the figure roughly contains one or more tracks or bypass channels on the inner surface of the bypass portion of the pressure chamber. The bypass channel may be parallel to the longitudinal direction of the transfer chamber, such as described in U.S. Patent No. 5,501,673. The bypass channels can also be arranged at an angle to the longitudinal direction, such as described in U.S. Patent No. 5,7,16,38. The number of channels is selected based on the amount of liquid being delivered, and is preferably on the order of 1 to 15. There are many other different ways of configuring the bypass section known in the art. It is important not to configure too many channels in view of the volume of liquid remaining in the channels when the liquid is transferred. It is also desirable to reduce the dead volume between any circumferential ridges held on the piston, by keeping the difference between the passing ridge and the inner diameter of the body of the piston to a small extent. According to another embodiment, the shape of the inner surface of the bypass portion is such that the piston changes in size when passing through the bypass portion. The paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) 514539 A7- -B7 V. Description of the invention (25) The shape 'allows liquid to pass from the storage chamber to the pressure chamber, such as in US Patent Nos. 5'472'422 and No. 5,817,055 (please read the precautions on the back first) Fill out this page again). The different steps performed are basically three-step procedures, including a transfer step for transferring liquid from the storage chamber to the pressure chamber, a step for removing air from the pressure chamber, and an injection step. Compared to the pressurization step, the liquid transfer step and the degassing step are preferably performed relatively slowly and at low pressure, so as not to cause cracking of the glass, overshoot of the plunger in the bypass portion, and foaming of the liquid 'Or liquid is sprayed through the opening. Only the injection step must be performed under high pressure. During the transfer step and during the air removal step, the device is preferably held in a nearly upright position, i.e. the front end opening of the pressure chamber is above the horizontal line, inclined, or approximately upward to prevent the liquid from pouring out. The invention is not limited to the preferred embodiments described above. Various options, modifications, and equivalents can be used. Therefore, the above-mentioned embodiments should not be regarded as limiting the scope of the present invention as defined by the scope of the accompanying patent application. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs This paper is sized to the Chinese National Standard (CNS) A4 (210 X 297 mm) _ 28-