TWI574707B - Syringe devices and syringe piston - Google Patents
Syringe devices and syringe piston Download PDFInfo
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- TWI574707B TWI574707B TW103142633A TW103142633A TWI574707B TW I574707 B TWI574707 B TW I574707B TW 103142633 A TW103142633 A TW 103142633A TW 103142633 A TW103142633 A TW 103142633A TW I574707 B TWI574707 B TW I574707B
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Description
本發明之實施例係關於注射裝置、注射活塞組態、藥劑製備系統及製備一藥劑之方法。 Embodiments of the invention relate to an injection device, an injection piston configuration, a pharmaceutical preparation system, and a method of preparing a medicament.
製備藥物或藥劑及將此等劑施打個人通常涉及混合兩個或兩個以上組份以形成劑且隨後將所混合之藥物輸送至個人。混合組份通常可涉及以流體形式自一瓶或其他容器提取一組份且將此等組份轉移至一容納另一組份之獨立容器中。在特定情況下，在施打之前，一瓶或容器之內容物之僅一部分待用於製備一混合物。因此，提取及轉移可涉及精確量測待混合之一或多個組份。 The preparation of a medicament or medicament and the application of such agents to a person typically involve mixing two or more components to form a dose and then delivering the mixed medicament to an individual. Mixing the components typically involves extracting one portion from a bottle or other container in fluid form and transferring the components to a separate container containing the other component. In certain instances, only a portion of the contents of a bottle or container is to be used to prepare a mixture prior to application. Thus, extraction and transfer can involve accurately measuring one or more components to be mixed.
當使用習知方法及裝置以便混合藥物及/或將藥物施打個人時可能發生多種問題。舉例而言，在多個組份待混合的情況下，提取並轉移一組份及將此組份引入至另一組份中可潛在地將組份之一或兩者曝露至一導致污染所得藥物之非無菌或被污染環境。此外，一或多個組份之不完全提取或不正確量測可導致製備及/或施打一不正確劑量。在特定情況下，一旦混合一藥物，即必須在施打個人之前將混合物再次自一瓶或容器提取至一注射器中。此額外轉移可導致污染、內容物之不完全提取及/或一組份或所得藥物之不準確量測的額外可能。 A variety of problems can occur when using conventional methods and devices to mix drugs and/or to administer drugs to individuals. For example, in the case where multiple components are to be mixed, extracting and transferring one component and introducing the component into another component may potentially expose one or both of the components to a result of contamination. Non-sterile or contaminated environment of the drug. In addition, incomplete extraction or incorrect measurement of one or more components can result in the preparation and/or application of an incorrect dose. In certain cases, once a drug is mixed, the mixture must be again extracted from a vial or container into a syringe before the individual is applied. This additional transfer can result in additional contamination of the contamination, incomplete extraction of the contents, and/or inaccurate measurement of a portion or resulting drug.
實務上，存在用於在轉移及/或混合組份或製備及轉移藥物期間維持無菌的無菌環境之有限可用性。額外誤差可由使用錯誤稀釋劑來 重構藥物而產生。最終，由於諸如需要存取諸如獨立瓶的經個別封裝之物品及/或轉移裝置，或量測待組合以形成藥物之一或多個組份的因素，使用多個組份製備藥物可能緩慢且耗時。 In practice, there is limited availability for maintaining a sterile sterile environment during transfer and/or mixing of components or during preparation and transfer of a drug. Additional errors can be made using the wrong diluent Produced by reconstituting the drug. Finally, the use of multiple components to prepare a drug may be slow due to factors such as the need to access individually packaged articles and/or transfer devices such as separate vials, or to measure factors to be combined to form one or more components of the drug. time consuming.
將需要開發用於製備及施打藥物的替代方法及系統。 Alternative methods and systems for preparing and administering drugs will need to be developed.
在一態樣中，本發明包含一注射裝置。該裝置包括一注射筒及具有一可***於注射筒內之第一端的活塞。活塞之一第二端與第一端相反，且活塞具有一界定於第一端與第二端之間的總長度。一瓶口安置於活塞內且經組態以沿活塞之總長度的一部分在縱長方位上接納一瓶。一流體過道自瓶口經過活塞之第一端而延伸經過活塞。 In one aspect, the invention comprises an injection device. The device includes a syringe and a piston having a first end insertable into the syringe. One of the second ends of the piston is opposite the first end and the piston has a total length defined between the first end and the second end. A bottle opening is disposed within the piston and is configured to receive a bottle in a longitudinal direction along a portion of the total length of the piston. A fluid aisle extends from the mouth of the bottle through the first end of the piston through the piston.
在一態樣中，本發明包含一注射活塞，其具有一包括一或多個突出部分之桿部分。一密封部分經覆模成型於桿部分上並覆蓋一或多個突出部分。 In one aspect, the invention comprises an injection piston having a stem portion that includes one or more projections. A sealing portion is overmolded onto the stem portion and covers one or more projections.
在另一態樣中，本發明包含一具有一注射筒及一注射活塞之注射裝置，該注射活塞具有一可***於注射筒內之第一端及一與第一端相反之第二端。一瓶外殼與活塞之第二端相關聯並自活塞之第二端延伸。一刺穿結構與活塞之第二端相關聯並延伸至瓶外殼中。 In another aspect, the invention comprises an injection device having a syringe and an injection piston, the injection piston having a first end insertable into the syringe and a second end opposite the first end. A bottle outer casing is associated with the second end of the piston and extends from the second end of the piston. A piercing structure is associated with the second end of the piston and extends into the bottle housing.
在一態樣中，本發明包含一注射裝置，該注射裝置包括一注射筒、一活塞套管及一套管***件。套管***件具有一可***於套管內之第一端及一相反之第二端。套管***件具有一由第一端與第二端之間的距離所界定之長度。一流體通道沿套管***件之一外側自第一端延伸套管***件之長度的至少一部分。一旋轉閥控制流體通道與注射筒之間的流體連通。 In one aspect, the invention comprises an injection device comprising a syringe, a piston cannula and a cannula insert. The cannula insert has a first end insertable into the sleeve and an opposite second end. The cannula insert has a length defined by the distance between the first end and the second end. A fluid passage extends at least a portion of the length of the cannula insert from the first end along an outer side of the cannula insert. A rotary valve controls fluid communication between the fluid passage and the syringe.
在一態樣中，本發明包含一注射裝置，該注射裝置具有一注射筒及一具有一套管***件之活塞套管，該套管***件具有一可***於套管內之第一端及一相反之第二端，該套管***件之一長度係由第一 端與第二端之間的距離所界定。一隔室安置於套管***件內，且一閥控制隔室與注射筒之間的流體連通。 In one aspect, the invention comprises an injection device having a syringe and a piston sleeve having a cannula insert having a first end insertable within the cannula And an opposite second end, the length of one of the sleeve inserts is first The distance between the end and the second end is defined. A compartment is disposed within the cannula insert and a valve controls fluid communication between the compartment and the syringe.
在另一態樣中，本發明包含一藥劑製備系統。該系統包括一注射器，該注射器具有一注射筒，其具有一內部腔室；一活塞，其具有一第一端、一第二端及一縱畏穿過活塞之流體過道，活塞之至少一部分包括***於腔室內之第一端。一閥與流體過道相關聯且包括一閥本體及一經覆模成型於閥本體上之蓋。 In another aspect, the invention comprises a pharmaceutical preparation system. The system includes a syringe having a syringe having an internal chamber, a piston having a first end, a second end, and a fluid passageway through the piston, at least a portion of the piston A first end inserted into the chamber is included. A valve is associated with the fluid aisle and includes a valve body and a cover overmolded onto the valve body.
本發明另外包含一種製備一用於施打個人之藥劑的方法。提供一注射器，其具有一注射筒及一安置於一相對於注射筒之初始位置處的活塞。活塞具有一活塞套管及一套管***件。將一第一組份提供於注射筒內，且將一第二組份提供於一瓶內。一閥與瓶與注射器之筒之間的流體過道相關聯。閥起初處於一阻塞經過過道之流體通路的閉合位置處。該方法包括重新定位閥及滑動活塞以接合第一組份與第二組份。將第一組份與第二組份混合以形成一藥劑且將該劑吸入至注射筒中。 The invention further comprises a method of preparing a medicament for administering an individual. A syringe is provided having a syringe and a piston disposed at an initial position relative to the syringe. The piston has a piston sleeve and a sleeve insert. A first component is provided in the syringe and a second component is provided in a vial. A valve is associated with a fluid aisle between the bottle and the barrel of the syringe. The valve is initially in a closed position that blocks the fluid passage through the aisle. The method includes repositioning a valve and a sliding piston to engage the first component and the second component. The first component is mixed with the second component to form a medicament and the dose is aspirated into the syringe.
在又一態樣中，本發明包括一種製備一組合物之方法，該方法包括提供一具有一含有一第一組份之筒腔室的注射筒及提供一具有一含有一第二組份之隔室的活塞。活塞包括一活塞套管及一套管***件。套管***件包括一尖端及一具有一密封部分之本體，該密封部分經覆模成型於尖端及活塞套管之一端上。密封部分具有穿過其中之至少一開口。該方法包括相對於套管***件旋轉活塞套管以建立隔室與筒腔室之間的流體連通。滑動活塞以接合第一組份與第二組份，且將第一組份與第二組份混合以形成一組合物。將組合物吸入至注射腔室中。 In still another aspect, the invention comprises a method of preparing a composition comprising providing a syringe having a cartridge chamber containing a first component and providing a cartridge having a second component The piston of the compartment. The piston includes a piston sleeve and a sleeve insert. The sleeve insert includes a tip and a body having a sealing portion that is overmolded onto one end of the tip and the piston sleeve. The sealing portion has at least one opening therethrough. The method includes rotating a piston sleeve relative to a cannula insert to establish fluid communication between the compartment and the barrel chamber. The piston is slid to join the first component and the second component, and the first component is mixed with the second component to form a composition. The composition is aspirated into the injection chamber.
10‧‧‧混合總成/混合/施打系統/系統 10‧‧‧Mixed assembly/mixing/handling system/system
100‧‧‧注射筒/注射器/注射本體 100‧‧‧ syringe/injector/injection body
102‧‧‧注射腔室/內部腔室 102‧‧‧Injection chamber/internal chamber
103‧‧‧內部錐形區域 103‧‧‧Internal cone area
200‧‧‧活塞/***件/注射活塞 200‧‧‧Piston/insert/injection piston
202‧‧‧第一端 202‧‧‧ first end
203‧‧‧活塞尖端/尖端 203‧‧‧Piston tip/tip
204‧‧‧第二端 204‧‧‧second end
205,205'‧‧‧活塞桿/桿 205,205'‧‧‧Piston rod/rod
206‧‧‧瓶口/口 206‧‧‧ bottle mouth / mouth
206a‧‧‧內部活塞瓶口 206a‧‧‧Internal piston bottle mouth
208,208a‧‧‧密封部分 208,208a‧‧‧ Sealing section
209‧‧‧開口 209‧‧‧ openings
210‧‧‧活塞翼片 210‧‧‧Piston fins
211‧‧‧接納槽 211‧‧‧Accept slot
213‧‧‧錐形壁 213‧‧‧Conical wall
219,219a‧‧‧開口 219,219a‧‧‧ openings
220‧‧‧通道/流體過道/流體通道 220‧‧‧Channel/fluid aisle/fluid channel
223,304,306‧‧‧突出部分 223,304,306‧‧‧ highlight
230‧‧‧套管***件/***件 230‧‧‧Sleeve inserts/inserts
231‧‧‧蓋部分/蓋 231‧‧‧Cover part/cover
232‧‧‧通道 232‧‧‧ channel
233‧‧‧桿部分/活塞桿/***件 233‧‧‧ rod part/piston rod/insert
234‧‧‧套環 234‧‧‧ collar
235‧‧‧桿部分 235‧‧‧ rod part
237‧‧‧附件 237‧‧‧Annex
239‧‧‧圓盤部分 239‧‧‧Disc section
240‧‧‧活塞套管/套管/套管部分 240‧‧‧ piston bushing/sleeve/sleeve section
242‧‧‧基礎環 242‧‧‧Foundation Ring
243‧‧‧第一端 243‧‧‧ first end
247‧‧‧第二端/相反端 247‧‧‧second end / opposite end
250‧‧‧開口 250‧‧‧ openings
255‧‧‧容器 255‧‧‧ container
257‧‧‧壓縮彈簧 257‧‧‧Compressed spring
258‧‧‧保持器 258‧‧‧keeper
260,262‧‧‧延伸翼片/翼片 260,262‧‧‧Extended fins/wings
300‧‧‧閥 300‧‧‧ valve
302‧‧‧閥本體 302‧‧‧ valve body
310‧‧‧閥蓋 310‧‧‧ bonnet
400‧‧‧刺穿結構/刺穿裝置 400‧‧‧ piercing structure/piercing device
401‧‧‧頭部區段/頭部部分 401‧‧‧Head section/head section
402‧‧‧尖端 402‧‧‧ tip
402a‧‧‧開口 402a‧‧‧ Opening
403‧‧‧桿/本體部分 403‧‧‧ rod/body part
404‧‧‧基礎表面 404‧‧‧Basic surface
406‧‧‧通道 406‧‧‧ channel
408‧‧‧存取孔 408‧‧‧ access hole
500‧‧‧瓶 500‧‧‧ bottles
510‧‧‧瓶外殼/外殼 510‧‧‧ bottle shell/shell
600‧‧‧瓶外殼 600‧‧‧ bottle shell
602‧‧‧外殼部件/第一部件/第一部分/容器部件 602‧‧‧Shell parts / first part / first part / container part
604‧‧‧第二部分/第二部件/部件/容器部件 604‧‧‧Part 2 / Second part / part / container part
606‧‧‧轉接器附件 606‧‧‧Adapter Accessories
608‧‧‧桿部分/桿 608‧‧‧ rod part/rod
620‧‧‧圓盤結構 620‧‧‧Disc structure
圖1為根據本發明之一態樣之混合總成的側視圖及部分橫截面 圖。 1 is a side view and partial cross section of a hybrid assembly in accordance with an aspect of the present invention Figure.
圖2為根據本發明之一態樣的注射裝置之一部分的側視圖及部分橫截面圖。 Figure 2 is a side elevation and partial cross-sectional view of a portion of an injection device in accordance with an aspect of the present invention.
圖3A為具有一安置於第一位置處之滑動外殼的注射裝置之一部分的側視圖。 Figure 3A is a side elevational view of a portion of an injection device having a sliding housing disposed at a first position.
圖3B為展示有安置於第二位置處之滑動外殼的圖3A之注射裝置之部分的側視圖。 Figure 3B is a side elevational view of the portion of the injection device of Figure 3A showing the sliding housing disposed at the second position.
圖4A為根據本發明之一態樣之混合總成的側視圖。 4A is a side elevational view of a mixing assembly in accordance with an aspect of the present invention.
圖4B為圖4A中所示之總成的分解圖。 Figure 4B is an exploded view of the assembly shown in Figure 4A.
圖5A為根據本發明之一態樣之注射活塞的分解側視圖。 Figure 5A is an exploded side elevational view of an injection piston in accordance with an aspect of the present invention.
圖5B為圖5A中所示之組裝注射裝置的局部放大圖。 Figure 5B is a partial enlarged view of the assembled injection device shown in Figure 5A.
圖5C為圖5A中所示之注射活塞之組裝部分的側視圖。 Figure 5C is a side elevational view of the assembled portion of the injection piston shown in Figure 5A.
圖6為根據本發明之一態樣的具有一可連接至替代桿部分之尖端部分之注射活塞的側視圖。 Figure 6 is a side elevational view of an injection piston having a tip portion connectable to an alternate stem portion in accordance with an aspect of the present invention.
圖7為根據本發明之一態樣之另一注射活塞組態的分解側視圖。 Figure 7 is an exploded side elevational view of another injection piston configuration in accordance with one aspect of the present invention.
圖8為根據本發明之一態樣之刺穿裝置的側視圖。 Figure 8 is a side elevational view of a piercing device in accordance with an aspect of the present invention.
圖9為一組裝組態中之圖7活塞裝置的側視圖。 Figure 9 is a side elevational view of the piston assembly of Figure 7 in an assembled configuration.
圖10為根據本發明之另一態樣之一替代混合總成的分解側視圖。 Figure 10 is an exploded side elevational view of an alternate mixing assembly in accordance with another aspect of the present invention.
圖11A為圖10中所示之系統之一部分的分解側視圖。 Figure 11A is an exploded side elevational view of a portion of the system shown in Figure 10.
圖11B為圖10中所描繪之系統的組裝形式之一部分的放大橫截面圖。 Figure 11B is an enlarged cross-sectional view of a portion of the assembled form of the system depicted in Figure 10.
圖12為具有替代特徵之圖10中所示之組裝裝置的側視圖。 Figure 12 is a side elevational view of the assembled device of Figure 10 with alternative features.
大體而言，本發明提供用於組合並混合組份以產生一混合物之方法及裝置且包含允許在未污染組份或混合劑或未將其曝露至一非無 菌環境的情況下發生此組合及混合的裝置組態。詳言之，本發明之方法涉及組合並混合組份以產生一諸如一藥物之施打準備劑且在特定態樣中包括將此劑施打個人。因此，本發明之裝置組態允許組合獨立組份，以使得組合與混合組份準備施打。隨附之圖1-圖12中說明根據本發明之一般概念及實例裝置。 In general, the present invention provides methods and apparatus for combining and mixing components to produce a mixture and comprising allowing uncontaminated components or mixtures or not exposing them to a non-negative This combined and mixed device configuration occurs in the case of a bacterial environment. In particular, the method of the present invention involves combining and mixing the components to produce a dosageing agent such as a drug and including the agent in a particular aspect. Thus, the device configuration of the present invention allows for the incorporation of separate components such that the combined and mixed components are ready to be applied. The general concepts and example apparatus in accordance with the present invention are illustrated in the accompanying Figures 1-12.
本文中所描述且例示之裝置元件及方法可結合2005年9月28日(自早先申請之申請案之後)申請的美國專利申請案第11/238,880號中所描述的裝置及方法使用或可為其替代組態。因此，來自此早先申請之申請案的說明書及圖以引用的方式併入本文中。應瞭解本發明之許多概念可結合包括習知注射裝置及元件、早先申請案中所描述的注射裝置及元件及仍待開發的注射裝置及元件之其他裝置組態使用或可適合於其他裝置組態。 The apparatus and method described and exemplified herein may be used in conjunction with the apparatus and method described in U.S. Patent Application Serial No. 11/238,880, filed on Sep. Its alternative configuration. The specification and figures of the application from this earlier application are hereby incorporated herein by reference. It will be appreciated that many of the concepts of the present invention can be used in conjunction with or can be adapted to other device groups, including conventional injection devices and components, injection devices and components described in the earlier applications, and injection devices and components yet to be developed. state.
在根據本發明之裝置用於製備一藥物的情況下，裝置較佳為閉合系統混合總成。圖1中說明根據本發明之一混合總成10之一實例。混合總成10可包含一注射本體(或筒)100及一具有一縱畏經過其長度(下文進一步論述)之一部分的流體過道之活塞200。在某些情況下，可存在一可逆附接蓋(未圖示)，其提供一在注射本體之一前端處的流體密封部分。 In the case where the device according to the invention is used to prepare a medicament, the device is preferably a closed system mixing assembly. An example of a hybrid assembly 10 in accordance with one embodiment of the present invention is illustrated in FIG. The mixing assembly 10 can include an injection body (or cartridge) 100 and a piston 200 having a fluid aisle that is a portion of its length (discussed further below). In some cases, there may be a reversible attachment cover (not shown) that provides a fluid tight portion at the forward end of one of the injection bodies.
活塞200具有界定活塞之總長度的一第一端202及一相反第二端204。一閥300與穿過活塞之長度之一部分的流體通道相關聯。一瓶口206沿活塞桿之長度之一區段而安置且經組態以將一瓶500縱畏接納於瓶口內。較佳地，經過活塞之流體過道自瓶口延伸經過第一端202。 The piston 200 has a first end 202 and an opposite second end 204 that define the total length of the piston. A valve 300 is associated with a fluid passage that passes through a portion of the length of the piston. A bottle opening 206 is disposed along a section of the length of the piston rod and is configured to receive a bottle of 500 intimidation within the mouth of the bottle. Preferably, the fluid passageway through the piston extends from the mouth of the bottle through the first end 202.
活塞200進一步包括一密封部分208，其能夠在注射本體的內壁與活塞密封部分的側壁之間形成一滑動流體緊密密封部分。閥300可經組態以選擇性地控制注射腔室與瓶500之間的流體連通。 The piston 200 further includes a sealing portion 208 that is capable of forming a sliding fluid tight seal between the inner wall of the injection body and the side wall of the piston seal portion. Valve 300 can be configured to selectively control fluid communication between the injection chamber and bottle 500.
參看圖2，此說明一流體過道220，其自第一端202延伸經過密封 部分208且經過活塞而縱畏延伸至瓶口206。一刺穿裝置400可與流體通道220相關聯且可延伸至口206中。一實例刺穿裝置可如早先申請之申請案中所描述。刺穿裝置400可具有一穿過其之流體通道且可經組態以刺穿瓶隔膜並保持跨越隔膜，從而建立瓶之內部與流體過道220之間的流體連通。 Referring to Figure 2, a fluid aisle 220 is illustrated that extends from the first end 202 through the seal Portion 208 extends through the piston to the mouth 206. A piercing device 400 can be associated with the fluid channel 220 and can extend into the port 206. An example piercing device can be as described in the earlier application. The piercing device 400 can have a fluid passage therethrough and can be configured to pierce the bottle septum and remain across the septum to establish fluid communication between the interior of the bottle and the fluid aisle 220.
瓶口206可藉由移除一或多個活塞凸片(fin)210之全部或一部分而形成。較佳地，保持足夠之凸片結構以允許瓶保持並穩定於口206內。 The mouth 206 can be formed by removing all or a portion of one or more piston fins 210. Preferably, a sufficient tab structure is maintained to allow the bottle to remain and stabilize within the port 206.
閥300可為(例如)一如所說明的雙向閥或可為一如早先申請之申請案中所描述的替代閥類型。 Valve 300 can be, for example, a two-way valve as illustrated or can be of the alternative valve type as described in the earlier application.
對於圖1及圖2中所示之注射總成而言，較佳起初以一在其中將瓶密封並安置於一相對於刺穿結構400之非接觸位置處的組態來提供裝置。在使用之準備中，瓶可經重新定位以接觸刺穿裝置400並滑入口內，從而允許裝置400刺穿並跨越隔膜。接著，可將閥300重新定位至一"打開"位置，從而建立瓶與注射腔室之間的流體連通。活塞相對於注射器之滑動可用以將注射內容物與瓶內容物組合。兩個組份可藉由重複滑動活塞或藉由攪拌裝置而混合。接著可將混合組份吸入至注射器中且閥閉合以為施打所製備之劑作準備。 For the injection assembly illustrated in Figures 1 and 2, the device is preferably initially provided in a configuration in which the bottle is sealed and disposed at a non-contact position relative to the piercing structure 400. In use preparation, the bottle can be repositioned to contact the piercing device 400 and slide into the inlet, allowing the device 400 to pierce and span the septum. Valve 300 can then be repositioned to an "open" position to establish fluid communication between the bottle and the injection chamber. Sliding of the piston relative to the syringe can be used to combine the injected contents with the contents of the bottle. The two components can be mixed by repeatedly sliding the piston or by means of a stirring device. The mixed component can then be aspirated into the syringe and the valve closed to prepare for the preparation of the application.
參看圖3A，說明一替代內部活塞瓶口組態。將與早先所描述之活塞相同的所說明之裝置的特徵同一地編號。藉由一附加字母或用一唯一數字識別符來表示相對於早先裝置為額外或不同的特徵。 Referring to Figure 3A, an alternative internal piston bottle port configuration is illustrated. The features of the illustrated device, which are identical to the pistons described earlier, are numbered identically. Additional or different features are indicated relative to the prior device by an additional letter or with a unique numeric identifier.
所說明之活塞200具有一自第一端202延伸至一內部活塞瓶口206a之內部過道。內部桿瓶口經組態以接納一可遮蓋一瓶(未圖示)之瓶外殼510。此瓶外殼可經由活塞之第二端204中的一開口而***。參看圖3B，複數個接納槽211可經組態以將外殼510引導並定位於瓶口內。活塞200可包含一與瓶口及流體過道相關聯的刺穿結構(未圖示)。較佳 可起初提供活塞200以使得將外殼510及一在內部接納於外殼內之瓶安置於一非接觸位置處，以使得刺穿裝置不接觸或不穿透瓶蓋或隔膜。在使用之準備期間，瓶外殼及內部瓶可朝向第一端202滑動以允許藉由刺穿裝置來穿透瓶隔膜或蓋，藉此建立瓶的內部與活塞的流體過道之間的流體連通。可藉由閥300來選擇性地控制經過過道之流體通路。製備一用於施打個人之藥劑可藉由提供一相關聯之注射器(未圖示)且使用類似於上文對於圖1中所描繪的裝置所描述之方法的方法來執行。 The illustrated piston 200 has an internal aisle that extends from the first end 202 to an internal piston finish 206a. The inner stem finish is configured to receive a vial 510 that covers a vial (not shown). The bottle housing can be inserted through an opening in the second end 204 of the piston. Referring to Figure 3B, a plurality of receiving slots 211 can be configured to guide and position the housing 510 within the finish. Piston 200 can include a piercing structure (not shown) associated with the mouth of the bottle and the fluid aisle. Better The piston 200 can be initially provided such that the outer casing 510 and a bottle that is internally received within the outer casing are placed in a non-contact position such that the piercing device does not contact or penetrate the bottle or membrane. During preparation for use, the bottle and inner bottles can slide toward the first end 202 to allow penetration of the bottle septum or cap by the piercing device, thereby establishing fluid communication between the interior of the bottle and the fluid aisle of the piston . The fluid passage through the aisle can be selectively controlled by valve 300. Preparation of a medicament for administering a personal can be performed by providing an associated syringe (not shown) and using a method similar to that described above for the apparatus depicted in FIG.
參看圖4A-圖4B描述本發明之另一替代組態。起初參看圖4A，說明一活塞200可***於一具有一內部腔室102之注射器100內。注射活塞200具有一內部過道，其縱畏經過以使得過道橫穿活塞之長度。藉由與此過道相關聯的閥300來選擇性地控制經過過道的流體通路。 Another alternative configuration of the present invention is described with reference to Figures 4A-4B. Referring initially to Figure 4A, a piston 200 can be inserted into a syringe 100 having an internal chamber 102. The injection piston 200 has an internal aisle that passes through the abutment so that the aisle traverses the length of the piston. The fluid passage through the aisle is selectively controlled by a valve 300 associated with this aisle.
如所說明，一第一端202(參見圖4B)***於注射筒內，且一瓶外殼600與活塞之第二端204相關聯。瓶外殼600可包含(例如)兩個部件602及604。第一部件602(在特定情況下)可為活塞200之一延伸。外殼部件602可與活塞200整合成一起，永久地附接至活塞200，或可逆地附接至活塞200。瓶外殼之一第二部分604可經組態以可與第一部分602接合，以使得一***於容器內之瓶可完全地封閉於外殼內。一藥物瓶之此封閉可防止瓶破損且可有利地避免移除及不正確地替代瓶及/或用可能含有一不正確稀釋劑或其他劑之另一瓶不小心地替換瓶。 As illustrated, a first end 202 (see FIG. 4B) is inserted into the syringe and a vial housing 600 is associated with the second end 204 of the piston. The bottle housing 600 can include, for example, two components 602 and 604. The first component 602 (in certain instances) may extend for one of the pistons 200. The outer casing component 602 can be integrated with the piston 200, permanently attached to the piston 200, or reversibly attached to the piston 200. The second portion 604 of the bottle housing can be configured to engage the first portion 602 such that a bottle inserted into the container can be completely enclosed within the housing. This closure of a drug bottle prevents damage to the bottle and can advantageously avoid removal and incorrect replacement of the bottle and/or inadvertent replacement of the bottle with another bottle that may contain an incorrect diluent or other agent.
外殼之第二部件604與外殼之第一部件的接合可包含(例如)將部件604之一部分***於第一部件中，將部件602之一部分***於部件604內，將兩個部件之一者擰入兩個部件之另一者中，及/或使用其他適當裝配或接合技術。在特定實施例中，部件604較佳可經組態以穩定於一第一位置處且一旦施加力(基於所使用之特定裝配組態之設計的滑動、扭轉或其他力)即可進一步在第二部件內延伸至一第二位 置。此組態可允許一封閉瓶自一相對於一刺穿裝置(參見圖4B)之第一"非接觸"位置移動至刺穿裝置能夠刺穿一瓶隔膜或其他瓶蓋套的一第二"存取"位置處且藉此提供對瓶內容物之存取。 Engagement of the second component 604 of the outer casing with the first component of the outer casing can include, for example, inserting a portion of the component 604 into the first component, inserting a portion of the component 602 into the component 604, and screwing one of the two components Into the other of the two components, and/or use other suitable assembly or joining techniques. In a particular embodiment, component 604 is preferably configurable to stabilize at a first location and upon application of force (sliding, torsional or other force based on the design of the particular assembly configuration used) The two parts extend to a second position Set. This configuration allows a closed bottle to be moved from a first "non-contact" position relative to a piercing device (see Figure 4B) to a second portion of the piercing device capable of piercing a bottle of septum or other capping sleeve. Access to the "location" and thereby provide access to the contents of the bottle.
在特定實施例中，瓶外殼部分可具有一轉接器附件606，其經組態以使注射裝置適於結合一注射泵使用。此附件較佳可包括一自部件604突出之桿608，其中該桿具有一第一直徑。桿部分608延伸至一圓盤結構610，其中該圓盤結構具有一大於桿結構之直徑且經組態用於***於一注射泵之一活塞桿中的一槽中。此組態可允許根據本發明之裝置用於一習知注射泵中。可***圓盤之存在(當***於注射泵之活塞桿的一槽中時)可防止當泵關閉時的柱塞之不小心前進。或者可手動操縱本發明之裝置。 In a particular embodiment, the bottle housing portion can have an adapter attachment 606 that is configured to adapt the injection device for use with a syringe pump. The attachment preferably includes a stem 608 that protrudes from the component 604, wherein the stem has a first diameter. The stem portion 608 extends to a disc structure 610, wherein the disc structure has a diameter that is larger than the diameter of the stem structure and is configured for insertion into a slot in one of the piston rods of a syringe pump. This configuration may allow the device according to the invention to be used in a conventional syringe pump. The presence of the insertable disc (when inserted into a slot of the piston rod of the syringe pump) prevents inadvertent advancement of the plunger when the pump is closed. Alternatively, the device of the present invention can be manually manipulated.
參看圖4B，此展示圖4A中所描繪之裝置的分解圖。此等圖說明刺穿裝置400之聯合，刺穿裝置400可處於活塞200之第二端204處且可延伸至瓶外殼之第一部件602中。圖4B另外說明閥300相對於活塞200之總長度的一替代置放。應瞭解閥300沿活塞之長度的置放並不限於任何特定位置且所描繪之位置僅為說明之目的。 Referring to Figure 4B, an exploded view of the device depicted in Figure 4A is shown. These figures illustrate the combination of the piercing device 400, which can be at the second end 204 of the piston 200 and can extend into the first component 602 of the bottle housing. FIG. 4B additionally illustrates an alternative placement of valve 300 relative to the overall length of piston 200. It should be understood that the placement of the valve 300 along the length of the piston is not limited to any particular location and the depicted position is for illustrative purposes only.
如圖4B中所進一步說明，一密封部分208可安裝於注射活塞200之第一端202上。密封部分208較佳具有一沿其長度之至少一部分的外徑，其在腔室壁與密封部分之間形成一流體密封部分。在活塞200包含一內部流體過道的情況下，密封部分208較佳可具有一或多個開口以允許活塞之內部過道與注射腔室之間的流體連通。 As further illustrated in FIG. 4B, a sealing portion 208 can be mounted to the first end 202 of the injection piston 200. The sealing portion 208 preferably has an outer diameter along at least a portion of its length that forms a fluid tight portion between the chamber wall and the sealing portion. Where the piston 200 includes an internal fluid aisle, the sealing portion 208 preferably has one or more openings to allow fluid communication between the internal passage of the piston and the injection chamber.
起初可將圖4A-圖4B中所描繪之混合/施打系統10提供於一"非接觸"位置處，在該處刺穿結構400未刺穿瓶500之蓋或隔膜。在一特定組態中，可至少在兩個外殼部件之接合處使用一塑性收縮膠膜來穩定容器部件602與604彼此相對的定位。收縮膠膜可提供一無菌保持器並防止刺穿裝置不小心或無意地與瓶隔膜嚙合。定位亦可或替代地使用 一定位焊接或其中提供一可藉由施加力(取決於特定容納組態及易破附接構件之定位的扭轉、滑動或其他力)而破壞的易破附接構件之成型附接構件穩定。所描述之注射裝置組態的兩部件容器部分可使用諸如塑性材料(較佳為硬塑性材料)之材料而形成。可使用(例如)RF焊接、微波焊接、熱焊接或其他適當塑性焊接來達成點焊接或定位焊接。 The mixing/applying system 10 depicted in Figures 4A-4B can initially be provided at a "non-contact" position where the piercing structure 400 does not pierce the lid or septum of the bottle 500. In a particular configuration, a plastic shrink film can be used at least at the junction of the two outer casing members to stabilize the positioning of the container members 602 and 604 relative to each other. The shrink film provides a sterile holder and prevents the piercing device from inadvertently or unintentionally engaging the bottle septum. Positioning can also or alternatively be used A form-fitting weld or a molded attachment member in which a breakable attachment member that can be broken by application of a force (torsion, slip or other force depending on the particular containment configuration and the location of the frangible attachment member) is stabilized. The two-part container portion of the described injection device configuration can be formed using a material such as a plastic material, preferably a hard plastic material. Spot welding or tack welding can be accomplished using, for example, RF welding, microwave welding, heat welding, or other suitable plastic welding.
參看圖5A-圖5C描述本發明之另一態樣。大體而言，本發明之此態樣涉及將彈性密封部分覆模成型於根據本發明之裝置之各種部件的硬塑性本體塊上。覆模成型涉及將一上覆部件直接成型於一下伏支撐部件上。應瞭解除本發明之此特定態樣中所特別描述的情況以外，覆模成型可配合替代活塞及閥本體來使用。替代活塞及閥本體可包括(例如)本文中所描述的替代活塞及閥、早先申請之申請案中所描述的活塞及閥、習知活塞及閥，及仍待開發之活塞及閥組態。 Another aspect of the present invention is described with reference to Figures 5A-5C. In general, this aspect of the invention relates to overmolding an elastomeric sealing portion onto a hard plastic body block of various components of the apparatus according to the present invention. Overmolding involves directly forming an overlying component onto a lower support member. In addition to the circumstances specifically described in this particular aspect of the invention, overmolding can be used in conjunction with an alternative piston and valve body. Alternative pistons and valve bodies may include, for example, the alternative pistons and valves described herein, the pistons and valves described in the earlier application, the conventional pistons and valves, and the piston and valve configurations yet to be developed.
起初參看圖5A，說明一活塞200，其具有一經組態以適合於一開口250之閥300，且具有一縱畏延伸經過活塞之通道220。說明一活塞密封部分208a，其具有一延伸經過密封部分之開口219。儘管圖5A以一分解圖說明活塞200，但是應瞭解在覆模成型過程期間，密封部分208a永久地附接至活塞。 Referring initially to Figure 5A, a piston 200 is illustrated having a valve 300 configured to fit an opening 250 and having a channel 220 extending longitudinally through the piston. A piston seal portion 208a is illustrated having an opening 219 that extends through the seal portion. Although FIG. 5A illustrates the piston 200 in an exploded view, it will be appreciated that the sealing portion 208a is permanently attached to the piston during the overmolding process.
活塞200較佳具有安置於活塞之第一端202處或附近的至少一突出部分223。該突出部分或該等突出部分可有利地支撐覆模成型密封部分並可輔助將密封部分保持於活塞之第一端上。在活塞經組態以具有一縱畏穿過其中之流體過道或通道的情況下，覆模成型過程較佳可提供覆模成型密封部分以使延伸經過密封部分之一或多個開口提供經過活塞的通路與一相關聯之注射本體的內部區域之間的流體連通。 The piston 200 preferably has at least one projection 223 disposed at or adjacent the first end 202 of the piston. The protruding portion or the protruding portions can advantageously support the overmolded sealing portion and can assist in retaining the sealing portion on the first end of the piston. Where the piston is configured to have a fluid aisle or passage therethrough, the overmolding process preferably provides an overmolded sealing portion for passage through one or more openings of the sealing portion The passage of the piston is in fluid communication with an associated inner region of the injection body.
所使用之覆模成型過程可適於各種注射本體設計，以使得覆模成型密封部分具有一前端，該前端經成形以符合注射本體之前端處的 注射本體之內部的錐形/形狀。密封部分較佳可經成型以提供一允許將密封部分***並移動於注射腔室內同時提供一沿腔室側壁之流體密封部分的密封直徑。在特定態樣中，密封模之直徑/尺寸可經修改以產生適合變化之注射筒尺寸的密封部分而不改變活塞尺寸/直徑。 The overmolding process used can be adapted to various injection body designs such that the overmolded sealing portion has a front end that is shaped to conform to the front end of the injection body The cone/shape of the inside of the injection body. The sealing portion is preferably shaped to provide a seal diameter that allows the sealing portion to be inserted and moved into the injection chamber while providing a fluid tight portion along the sidewall of the chamber. In a particular aspect, the diameter/size of the seal mold can be modified to produce a seal portion that is adapted to the varying syringe size without changing the piston size/diameter.
在一類似態樣中，閥300可包含一閥本體302及一覆模成型閥蓋310。閥本體302較佳可具有經組態以支撐並保持覆模成型蓋310的一或多個突出部分304、306。 In a similar aspect, valve 300 can include a valve body 302 and an overmolded valve cover 310. The valve body 302 preferably has one or more protruding portions 304, 306 configured to support and retain the overmolded cover 310.
閥300可為(例如)一如圖5A中所說明之推挽型閥。在所示之組態中，推挽閥本體在閥之***端處具有一較大突出部分306。大突出部分之存在可提供一形狀組態以當將閥拉至一打開位置處時輔助將閥定位及/或保持於口內。應瞭解本發明涵蓋使用替代閥類型，例如，一具有一穿過本體及覆模成型密封部分之開口的可旋轉閥。 Valve 300 can be, for example, a push-pull type valve as illustrated in Figure 5A. In the configuration shown, the push-pull valve body has a larger projection 306 at the insertion end of the valve. The presence of the overhanging portion provides a shape configuration to assist in positioning and/or retaining the valve within the mouth when the valve is pulled to an open position. It will be appreciated that the present invention contemplates the use of alternative valve types, for example, a rotatable valve having an opening through the body and overmolding the sealing portion.
閥蓋310及密封部分208a可包含(例如)彈性材料。所使用的彈性材料可相同或可彼此不同。類似地，活塞200及閥本體302可由硬塑性材料形成且可相同或可相對於彼此不同。可使用的彈性材料之實例包括(但不限於)聚胺酯、聚丙烯-EPDM、其他聚丙烯、聚矽氧烷及/或聚矽氧材料、丁基材料、異戊二烯、氯丁橡膠、聚乙烯及各種共聚物、複合物、摻合物或此等材料之其他組合。可用於活塞及/或閥本體形成的塑膠之實例包括(但不限於)聚乙烯、聚丙烯、聚環烯烴、聚氯乙稀(PVC)、聚醯胺(包括脂肪族及芳族變體)、聚酯、聚碳酸酯、聚丙烯酸酯、聚胺酯、共聚物、摻合物、複合物及其組合。 The bonnet 310 and the sealing portion 208a may comprise, for example, an elastomeric material. The elastic materials used may be the same or may be different from each other. Similarly, piston 200 and valve body 302 may be formed of a hard plastic material and may be the same or may be different relative to each other. Examples of elastomeric materials that may be used include, but are not limited to, polyurethane, polypropylene-EPDM, other polypropylene, polyoxyalkylene and/or polyoxyxides, butyl materials, isoprene, neoprene, poly Ethylene and various copolymers, composites, blends or other combinations of such materials. Examples of plastics that can be used in the formation of pistons and/or valve bodies include, but are not limited to, polyethylene, polypropylene, polycycloolefins, polyvinyl chloride (PVC), polyamines (including aliphatic and aromatic variants). , polyesters, polycarbonates, polyacrylates, polyurethanes, copolymers, blends, composites, and combinations thereof.
轉至圖5B，此說明藉由突出部分223所支撐之活塞200上的覆模成型密封部分208a。亦說明縱畏穿過活塞並穿過密封部分208a之通道220。參看圖5C，此說明藉由突出部分304及306所支撐的閥本體302上之覆模成型蓋310。 Turning to Fig. 5B, the overmolded sealing portion 208a on the piston 200 supported by the protruding portion 223 is illustrated. It also illustrates the passage 220 that passes through the piston and through the sealing portion 208a. Referring to Figure 5C, the overmolded cover 310 on the valve body 302 supported by the projections 304 and 306 is illustrated.
在覆模成型用以形成根據本發明之活塞及/或閥的情況下，桿/本 體部分可在一第一過程中製造且覆模成型密封部分/蓋部分可在一第二過程中形成。覆模成型將直接將密封部分/蓋形成於本體或桿部分上。可在形成下伏部件之後直接發生覆模成型，或可起初形成下伏部件且在覆模成型過程之前將其自相應模移除、轉移及/或儲存。 In the case of overmolding to form a piston and/or valve according to the present invention, the rod/book The body portion can be fabricated in a first process and the overmolded sealing portion/cover portion can be formed in a second process. Overmolding will directly form the sealing portion/cover on the body or stem portion. Overmolding may occur directly after forming the underlying component, or the underlying component may be initially formed and removed, transferred, and/or stored from the corresponding die prior to the overmolding process.
覆模成型過程可有利地避免活塞或本體相對於蓋或栓的手動組裝。提供一覆模成型彈性密封部分之額外優點包括最小化或防止了密封部分與下伏活塞之間的流體洩漏，及一安全附接以使得密封部分在活塞相對於注射器旋轉或拉動注射器內之活塞期間不會拉離下伏活塞。此外，密封部分可經組態以具有一跨越活塞之第一端的薄壁。相對於習知活塞密封部分，覆模成型密封部分之薄壁可減小活塞回彈且藉此最小化經由注射器之尖端而返回的流體之回流。此外，密封部分可經成型以在前面(未圖示)上具有一中心突起，該中心突起經組態以至少部分地***於經過注射尖端之流體通路中以進一步最小化保持於注射器中的流體。此特徵可對於昂貴藥劑之施打尤其有利。 The overmolding process advantageously avoids manual assembly of the piston or body relative to the lid or plug. Additional advantages of providing an overmolded elastomeric seal portion include minimizing or preventing fluid leakage between the seal portion and the underlying piston, and a secure attachment such that the seal portion rotates or pulls the piston within the syringe relative to the syringe The piston will not be pulled away during the period. Additionally, the sealing portion can be configured to have a thin wall that spans the first end of the piston. The thin wall of the overmolded sealing portion reduces the rebound of the piston and thereby minimizes backflow of fluid returning through the tip of the syringe, relative to conventional piston seal portions. Additionally, the sealing portion can be shaped to have a central protrusion on the front face (not shown) that is configured to be at least partially inserted into the fluid passageway through the injection tip to further minimize fluid retained in the syringe . This feature can be particularly advantageous for the application of expensive pharmaceutical agents.
參看圖6，覆模成型亦可結合一多部件活塞組態使用。在此態樣中，一活塞密封部分208可經覆模成型於一活塞尖端203上，活塞尖端203可擰入或否則附接至替代活塞桿205、205'。桿205與205'及尖端203可具有內部流體過道或可替代地為實心塊。可藉由將尖端之一附接部分***於桿205或205'之一開口209中而將尖端203接合至一活塞桿205或205'。在特定組態中，接合可使用擰螺絲、搭扣鎖、壓配合、塗覆一適當黏著劑或其他適當接合技術。 Referring to Figure 6, overmolding can also be combined with a multi-component piston configuration. In this aspect, a piston seal portion 208 can be overmolded onto a piston tip 203 that can be screwed or otherwise attached to the replacement piston rod 205, 205'. The rods 205 and 205' and the tip 203 can have internal fluid passages or alternatively solid blocks. The tip 203 can be joined to a piston rod 205 or 205' by inserting one of the tip attachment portions into one of the openings 209 of the stem 205 or 205'. In a particular configuration, the joint can be screwed, snap-locked, press-fitted, coated with a suitable adhesive or other suitable joining technique.
覆模成型密封部分208可經成型以具有一直徑"d1"，直徑"d1"可取決於將使用之注射本體(未圖示)的直徑而改變。尖端連同覆模成型密封部分一起可與一供特定注射筒使用的適當直徑(例如，d2或d3)之一活塞接合。因此，一單一尖端組態可用於廣泛的密封部分、注射筒及活塞尺寸。 Cover molding the sealing portion 208 may be formed to have a diameter, diameter "d 1" may be used depending on the injection body (not shown) of "d 1" is changed. Together with an appropriate diameter tip portion may cover molding for sealing with a syringe with a particular use (e.g., d 2 or d 3) one of the piston engagement. Therefore, a single tip configuration can be used for a wide range of seals, syringes and piston sizes.
參看圖7-圖9描述本發明之另一實施例。起初參看圖7，活塞200可包括一活塞套管240及一經組態以***於套管240內之套管***件230。套管部分240可具有一安裝於第一端202上的密封部分208。密封部分可具有一開口219a，該開口219a穿過密封部分之側且與一穿過套管部分240之類似開口對準。套管240可另外具有一基礎環242或其他基礎結構以允許操縱套管。 Another embodiment of the present invention is described with reference to Figures 7-9. Referring initially to Figure 7, the piston 200 can include a piston sleeve 240 and a sleeve insert 230 configured to be inserted into the sleeve 240. The sleeve portion 240 can have a sealing portion 208 mounted to the first end 202. The sealing portion can have an opening 219a that passes through the side of the sealing portion and is aligned with a similar opening through the sleeve portion 240. The sleeve 240 can additionally have a base ring 242 or other chassis to allow manipulation of the sleeve.
套管***件230可包含一通道232，該通道232自活塞***件之一第一端243開始沿***件的一外表面並穿過一在***件之相反端247處之套環234。一刺穿結構400可經提供以與活塞***件之第二端247相結合。參看圖8，此展示一可結合圖7中所說明之活塞使用的刺穿裝置組態之一實例的詳細組態。 The cannula insert 230 can include a channel 232 that extends from a first end 243 of the piston insert along an outer surface of the insert and through a collar 234 at the opposite end 247 of the insert. A piercing structure 400 can be provided for engagement with the second end 247 of the piston insert. Referring to Figure 8, this shows a detailed configuration of one example of a piercing device configuration that can be used in conjunction with the piston illustrated in Figure 7.
刺穿結構400描繪一根據本發明之說明性刺穿結構。可將刺穿結構400描述為具有一頭部區段401，該頭部區段401包含一安置於一第一端處的尖端402。刺穿結構400另外具有一桿/本體部分403，其自頭部部分401延伸至一安置於結構之與第一端相反之一第二端處的基礎表面404。一通道406或替代流體過道延伸經過基礎表面且較佳經過本體部分403之整體。 Piercing structure 400 depicts an illustrative piercing structure in accordance with the present invention. The piercing structure 400 can be described as having a head section 401 that includes a tip end 402 disposed at a first end. The piercing structure 400 additionally has a stem/body portion 403 that extends from the head portion 401 to a base surface 404 disposed at a second end of the structure opposite the first end. A channel 406 or an alternate fluid aisle extends through the base surface and preferably through the body portion 403.
刺穿結構400較佳可包含一開口402a，一旦刺穿結構之底座與活塞200結合，開口402a即與***件200之通道232對準。 The piercing structure 400 preferably includes an opening 402a that is aligned with the channel 232 of the insert 200 once the base of the piercing structure is coupled to the piston 200.
圖8中所示之刺穿結構為一說明性形狀及形式。在本發明之一較佳態樣中，通道406延伸小於頭部區段401之一內部長度的整體，以使得通道不穿過尖端402。相反地，一或多個存取孔408經提供(例如)經過頭部部分之外表面的一或兩者。其中通道不穿過尖端之刺穿結構的組態可有利地最小化或防止在一刺穿操作期間將一隔膜材料除芯或堵塞通道。早先申請之申請案中陳述了關於刺穿結構之額外態樣。 The piercing structure shown in Figure 8 is an illustrative shape and form. In a preferred aspect of the invention, the channel 406 extends less than the entirety of the inner length of one of the head segments 401 such that the channel does not pass through the tip 402. Conversely, one or more access apertures 408 are provided, for example, through one or both of the outer surfaces of the head portion. The configuration of the piercing structure in which the passage does not pass through the tip can advantageously minimize or prevent the removal of a diaphragm material or clogging of the passage during a piercing operation. Additional aspects of the piercing structure are set forth in the earlier application.
接下來參看圖9，此說明在一組裝組態中的圖7中所示之活塞裝 置。將套管***件230***於套管部分240內。***件230可相對於套管部分240旋轉以允許裝置之兩個部件充當一可旋轉閥。通常，組裝結構之第一端202將***於一注射筒(未圖示)內。裝置起初可具備一隨附瓶以使得瓶隔膜為完整的。在施打一藥劑的準備中，刺穿結構400可用以刺穿瓶隔膜。相對於套管240旋轉***件230可用以將***件的流體通道與經過活塞密封部分之開口219a及經過活塞套管之相應開口對準。此對準可建立注射腔室與瓶之間的流通連通。可如上文所描述地執行藥物組份的隨後之組合及混合。一旦完成混合，即可藉由相對於套管旋轉***件230來閉合閥。施打準備組合物可接著被施打或可在施打之前被儲存。 Referring next to Figure 9, this illustrates the piston assembly shown in Figure 7 in an assembled configuration. Set. The cannula insert 230 is inserted into the cannula portion 240. The insert 230 is rotatable relative to the sleeve portion 240 to allow the two components of the device to act as a rotatable valve. Typically, the first end 202 of the assembled structure will be inserted into a syringe (not shown). The device may initially have an accompanying bottle to make the bottle septum intact. The piercing structure 400 can be used to pierce the bottle septum in preparation for administering a medicament. Rotating the insert 230 relative to the sleeve 240 can be used to align the fluid passage of the insert with the opening 219a through the piston seal portion and through the corresponding opening of the piston sleeve. This alignment establishes a flow communication between the injection chamber and the bottle. Subsequent combinations and mixing of the pharmaceutical components can be performed as described above. Once the mixing is complete, the valve can be closed by rotating the insert 230 relative to the cannula. The application composition can then be applied or can be stored prior to application.
圖10-圖12中描繪具有一多部件活塞之另一混合及施打系統10。起初參看圖10，系統10可包括一具有一內部腔室102之注射筒100。系統10另外包括一包括一活塞套管240及一套管***件230的活塞200。可將***件230描述為具有一桿部分233，桿部分233之至少一部分為中空以充當一容器255。一***件蓋部分231可經組態以附接至活塞桿233，藉此覆蓋並封閉容器255。一附件237可自活塞***件延伸。附件237可包含一桿部分235及一圓盤部分239，其中圓盤部分239經組態以適合一注射泵之一活塞桿上的一槽。 Another mixing and actuation system 10 having a multi-component piston is depicted in Figures 10-12. Referring initially to Figure 10, system 10 can include a syringe 100 having an internal chamber 102. System 10 additionally includes a piston 200 including a piston sleeve 240 and a sleeve insert 230. The insert 230 can be described as having a stem portion 233 with at least a portion of the stem portion 233 being hollow to serve as a container 255. An insert cover portion 231 can be configured to attach to the piston rod 233, thereby covering and closing the container 255. An attachment 237 can extend from the piston insert. The attachment 237 can include a stem portion 235 and a disc portion 239, wherein the disc portion 239 is configured to fit a slot in one of the piston rods of a syringe pump.
套管部分240可包括一活塞密封部分208。密封部分208較佳可經覆模成型且可包含一具有匹配注射腔室102之內部錐形區域103之錐形壁213的形狀。 The sleeve portion 240 can include a piston seal portion 208. The sealing portion 208 is preferably overmolded and may include a shape having a tapered wall 213 that matches the inner tapered region 103 of the injection chamber 102.
參看圖11A，蓋部分231可經組態以使用一***壓縮彈簧257及一上覆保持器258來提供閥作用。蓋231及保持器258可由諸如上文所描述之材料的硬塑性材料形成。彈簧257可由一諸如上文所陳述之彼等彈性材料的彈性材料形成。 Referring to Figure 11A, the cover portion 231 can be configured to provide a valve action using an insertion compression spring 257 and an overlying retainer 258. Cover 231 and retainer 258 may be formed from a hard plastic material such as the materials described above. The spring 257 can be formed from an elastic material such as the elastic material as set forth above.
接下來參看圖11B，在所說明之實施例中，覆模成型密封部分 208可經覆模成型於活塞套管240上且亦可經覆模成型於蓋231上。在覆模成型過程之前提供內部閥彈簧及保持器。一旦完成覆模成型過程，即可藉由將桿***於套管部分240內來定位桿部分233。在***於套管中時，***件233之內部容器將通常含有一諸如一凍乾粉末之藥劑的組份。蓋231及桿部分233較佳可經組態以包括一搭扣配合、壓配合或其他適當接合組態，以使得一旦經接合，蓋及桿部分即不會在拉回活塞時拉開。 Referring next to Figure 11B, in the illustrated embodiment, the overmolded sealing portion 208 can be overmolded onto the piston sleeve 240 and overmolded onto the cover 231. An internal valve spring and retainer are provided prior to the overmolding process. Once the overmolding process is completed, the stem portion 233 can be positioned by inserting the rod into the sleeve portion 240. When inserted into the cannula, the inner container of insert 233 will typically contain a component such as a lyophilized powder. Cover 231 and stem portion 233 are preferably configured to include a snap fit, press fit, or other suitable engagement configuration such that once engaged, the cover and stem portions are not pulled apart when the piston is pulled back.
圖12展示一類似於圖10中所示之裝置並具有額外可選特徵的組裝裝置。如所說明，將包含套管240及***件230之活塞200***於一注射筒100內。套管240可包含延伸翼片(extension tab)262，且***件230亦可包含延伸翼片260。延伸翼片存在於套管上，且***件可輔助操縱與活塞相關聯之閥。在A方向上一起擠壓翼片可打開閥。接著可執行相對於套管(方向B)旋轉***件以定位翼片來"鎖定"套管並***彼此相對的位置，藉此將閥鎖定至打開位置處。為了閉合閥，可在一相反方向上旋轉***件且可將翼片260相對於翼片262移開。 Figure 12 shows an assembly device similar to the device shown in Figure 10 with additional optional features. As illustrated, the piston 200 including the cannula 240 and the insert 230 is inserted into a syringe 100. The sleeve 240 can include an extension tab 262, and the insert 230 can also include an extension tab 260. An extension flap is present on the sleeve and the insert assists in manipulating the valve associated with the piston. Squeezing the flaps together in the A direction opens the valve. The insert can then be rotated relative to the cannula (direction B) to position the tabs to "lock" the cannula and insert the positions opposite each other thereby locking the valve to the open position. To close the valve, the insert can be rotated in the opposite direction and the tab 260 can be removed relative to the tab 262.
除***件230內之內部容器替代較早所描述之瓶以外，可以一類似於上文所描述之方式的方式執行使用圖12中所描繪之裝置來製備一施打準備劑。圖12中所示之混合/施打系統10可另外包括一與活塞及相反注射器100相關聯之附件，其中此附件經組態以允許***於一注射泵之一活塞桿的一槽中。 In addition to the inner container in the insert 230, in place of the bottle described earlier, a device prepared using the apparatus depicted in Figure 12 can be used to prepare a apply preparation in a manner similar to that described above. The mixing/applying system 10 shown in Figure 12 can additionally include an attachment associated with the piston and the counter injector 100, wherein the attachment is configured to permit insertion into a slot of one of the piston rods of a syringe pump.
本文中所描述之實施例之裝置的封裝可使用習知封裝技術，或可使用早先申請之申請案中所描述的適於被封裝之特定裝置的封裝技術。 The packaging of the devices of the embodiments described herein may use conventional packaging techniques, or may employ packaging techniques suitable for the particular device being packaged as described in the earlier application.
本文中所描述之特徵及實施例可在適當的情況下彼此組合，且可結合早先申請之申請案中所揭示的特徵及實施例使用。本發明之特徵及實施例可適於或適合於與習知注射元件、瓶及裝置以及仍待開發 之彼等結合使用。 The features and embodiments described herein can be combined with each other where appropriate and can be used in conjunction with the features and embodiments disclosed in the application of the earlier application. Features and embodiments of the present invention may be adapted or adapted to conventional injection components, bottles and devices, and still to be developed They are used in combination.
10‧‧‧混合總成/混合/施打系統/系統 10‧‧‧Mixed assembly/mixing/handling system/system
100‧‧‧注射筒/注射器/注射本體 100‧‧‧ syringe/injector/injection body
102‧‧‧注射腔室/內部腔室 102‧‧‧Injection chamber/internal chamber
103‧‧‧內部錐形區域 103‧‧‧Internal cone area
200‧‧‧活塞/***件/注射活塞 200‧‧‧Piston/insert/injection piston
208‧‧‧密封部分 208‧‧‧ sealing part
213‧‧‧錐形壁 213‧‧‧Conical wall
230‧‧‧套管***件/***件 230‧‧‧Sleeve inserts/inserts
231‧‧‧蓋部分/蓋 231‧‧‧Cover part/cover
233‧‧‧桿部分/活塞桿/***件 233‧‧‧ rod part/piston rod/insert
235‧‧‧桿部分 235‧‧‧ rod part
237‧‧‧附件 237‧‧‧Annex
239‧‧‧圓盤部分 239‧‧‧Disc section
240‧‧‧活塞套管/套管/套管部分 240‧‧‧ piston bushing/sleeve/sleeve section
255‧‧‧容器 255‧‧‧ container
Claims (14)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US76364706P | 2006-01-30 | 2006-01-30 | |
| US11/558,146 US8137307B2 (en) | 2005-11-09 | 2006-11-09 | Syringe devices, components of syringe devices, and methods of forming components and syringe devices |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| TW201509460A TW201509460A (en) | 2015-03-16 |
| TWI574707B true TWI574707B (en) | 2017-03-21 |
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Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| TW103142633A TWI574707B (en) | 2006-01-30 | 2007-01-30 | Syringe devices and syringe piston |
| TW096103375A TWI481428B (en) | 2006-01-30 | 2007-01-30 | Syringe device and method of preparing a composition |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| TW096103375A TWI481428B (en) | 2006-01-30 | 2007-01-30 | Syringe device and method of preparing a composition |
Country Status (1)
| Country | Link |
|---|---|
| TW (2) | TWI574707B (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI655011B (en) * | 2016-05-18 | 2019-04-01 | 瑞士商瑞健醫療股份有限公司 | Administration mechanism for a medicament delivery device |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI495492B (en) * | 2014-03-27 | 2015-08-11 | Taiwan Biomaterial Co Ltd | Syringe |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5372586A (en) * | 1993-10-20 | 1994-12-13 | Habley Medical Technology Corp. | Telescoping pharmaceutical storage and mixing syringe |
| US5637100A (en) * | 1992-11-27 | 1997-06-10 | Daikyo Seiko, Ltd. | Syringe-cum-container |
| TW526069B (en) * | 2001-04-10 | 2003-04-01 | Sod Conseils Rech Applic | Injection device |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4861335A (en) * | 1985-07-26 | 1989-08-29 | Duoject Medical Systems Inc. | Syringe |
| AU5639099A (en) * | 1998-09-04 | 2000-03-27 | Owen Mumford Limited | Improvements relating to fluid tranfer assemblies |
| GB0130140D0 (en) * | 2001-12-18 | 2002-02-06 | Dca Design Int Ltd | Improvements in and relating to medicament delivery service |
| TWI226839B (en) * | 2003-08-27 | 2005-01-21 | Micro Star Int Co Ltd | Intravenous injection device |
-
2007
- 2007-01-30 TW TW103142633A patent/TWI574707B/en not_active IP Right Cessation
- 2007-01-30 TW TW096103375A patent/TWI481428B/en not_active IP Right Cessation
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5637100A (en) * | 1992-11-27 | 1997-06-10 | Daikyo Seiko, Ltd. | Syringe-cum-container |
| US5372586A (en) * | 1993-10-20 | 1994-12-13 | Habley Medical Technology Corp. | Telescoping pharmaceutical storage and mixing syringe |
| TW526069B (en) * | 2001-04-10 | 2003-04-01 | Sod Conseils Rech Applic | Injection device |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI655011B (en) * | 2016-05-18 | 2019-04-01 | 瑞士商瑞健醫療股份有限公司 | Administration mechanism for a medicament delivery device |
Also Published As
| Publication number | Publication date |
|---|---|
| TW200744696A (en) | 2007-12-16 |
| TW201509460A (en) | 2015-03-16 |
| TWI481428B (en) | 2015-04-21 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MM4A | Annulment or lapse of patent due to non-payment of fees |