TWI339114B - Fluid transfer device and drug bottle for use in an infusion system, and method for fluid transfer in such a system - Google Patents
Fluid transfer device and drug bottle for use in an infusion system, and method for fluid transfer in such a system Download PDFInfo
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- TWI339114B TWI339114B TW92106323A TW92106323A TWI339114B TW I339114 B TWI339114 B TW I339114B TW 92106323 A TW92106323 A TW 92106323A TW 92106323 A TW92106323 A TW 92106323A TW I339114 B TWI339114 B TW I339114B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/10—Bag-type containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1475—Inlet or outlet ports
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2006—Piercing means
- A61J1/201—Piercing means having one piercing end
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2006—Piercing means
- A61J1/2013—Piercing means having two piercing ends
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2048—Connecting means
- A61J1/2051—Connecting means having tap means, e.g. tap means activated by sliding
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- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Description
1339114 玖、發明說明: 【發明所屬之技術領域】 本發明關於一種用於一輸液系統之流體輸送裝置,該装 置具備一弟一端、一對向於該第一端之弟一端,該第二端 設計並排列為用來耦接於該輸液系統之一注入埠,其中該 流體輸送裝置包含至少一第一構件、一附接於該第一構件 之中空針頭、及一可以一容許該中空針頭刺穿一密封該注 入埠之彳堯性障壁構件以造成一從該第一端經由該注入棒進 · 入該輸液系統内之流體通路的方式相對於該第一構件伸縮 地位移的系二構件。本發明亦關於一種與該流體輸送装置 一同使用之樂瓶’以及一種使用該流體輸送裝置之流體输 送方法。 【先前技術】 關於藥物準備、藥物給予及其他相似搬運作業有一嚴重 問題在於醫療人員和藥理人員暴露於可能逸入環境空氣中 之藥物或溶劑。此問題在關係到細胞毒素類、抗病毒藥物 麵) 、抗生素類及放射性藥物之時特別重要。 為此之故’頃需要較安全的系統來搬運和給予藥物及其 他醫療物質。 因此’美國專利第4,564,0 54號(Gustavs so η)揭示一種流體 輸送裝置用來將一物質從一容器輸送至另一容器且同時避 免液體和氣體污染物漏洩。該裝置包括一設計成一中空套 筒且有一具備一通道之穿刺構件的第一構件。該穿刺構件 附接於該第一構件,該第一構件在一端有一正對向於該穿 839% -6 - 1339114 刺構件〈尖梢的第一障壁構件。因此該穿刺構件得穿過密 封涊弟一構件之一端的該第一障壁構件及縮回。該流體輸 达裝置更包括一附接或可附接於該等容器其中之一或是排 γ為只忒等容器連通之構件的第二構件。該第二構件有一 第一卩早壁構件,且有匹配連接構件排列在該第一和第二構 :上用來h供_第—和第二構件相互之—可釋鎖定。該等 :壁構件是防液防氣的密封構件,其在該穿剌構件刺入和 :口:俊罕固密封且防止液體和氣體污染物漏洩。在該第 。1 4件處A連接&置’該等障壁構件相互定位為讓 以穿刺構件能穿過該等障壁構件。 依據美國專利第4,564,〇54號,上述穿刺構件是一安排為 :來刺芽該第一和第二障壁構件的針頭,”對向於該第 構件之-端的末端具有用來密封性地接受或永久性地附 =一用來對附接於該第二構件之容器柚取及/或加入物 射器或類似物的構件。該注射器或類似物在附接於 與針頭之通道連通,是以處於縮回位置的針 "于閉在有》王射器或類似物相連之第—構件内。 連:=公告案wo 99/27886號(f—等人)揭示-種 間建預期中其用來在-第-容器與-第二容器之 第連…連接器裝置包括-具有-第-端和一 -適:附接至=構件’其中該第-套筒構件在第-端有 更包括-具有=1器的第—附接構件。該連接器裝置 該第二套汽構件“和端〈第二套筒構件。藉此 牛Η孩弟一套筒構件聯合且可相對於該第一 1339114 套:構件從一不活動位置移動至一活動位置,#中該第二 套:構件在弟二端有—適於將該第二套筒構件附接至該第 一各态的第二附接構件。依據w〇 99/27886號,該姑 置更包括-從該第—和第二套筒構件其中之—突出二 供-從該第一容器到該第二容器纟流體流徑的第—和第二 穿剌構件’以及用來獨立地氣密密封該第一和第二構:: 構件。 此外,美國專利第6,258 〇78 B丨號揭示一種協助—皮下注 射器與小藥瓶(vial)之連接的魯厄(丨uer)連接器,其包括一 可連接至一注射器的丨uer連接器,且其延伸至一能受驅使通 過一可穿孔小藥瓶封閉件以藉此刺破該封閉件之尖端;一 可安裝在一小藥瓶上之luer連接器支撐件,且其在〜開始時 將該luer連接器支撐於一第一位置,在此位置該導管尖端指 向該封閉件;及一丨uer連接器驅動器,該驅動器相對於該支 撐件之移動導致該luer連接器受帶動使得該尖端刺破該封 閉件並進入該小藥瓶。 在進行輸液時’經常需要將一藥物或其他醫療物气主入 在一輸液袋或其他輸液流體容器内部的輸液流體内。這通 常是用一装滿所述醫療’/瓦體之;主射器之一針頭刺穿輪、·夜代 或輸液流體管線上一注入埠之一隔膜或其他流體障壁的方 式達成。 然而,頃發現在使用一依據習知技藝之常規注射器或其 他裝置將危險物質(例如細胞毒素類)注入一輸液袋或輸液 流體管線内時可能因為漏洩而對工作環境造成污染。這各 839% -8- 然是吾人所不希望的。為此之故,需要一種能消減將一藥 物或其他醫療物質注入一輸液系統内時潛在性有害健康的 物質逸入環境空氣或工作環境内之可能性的改良裝置,且 該裝置能在注入作業完成後安全地脫離輸液系統。 【發明内容】 因此,本發明之一第一目的為提出一種簡單、可靠且安 全的流體輸送裝置,其用在將一醬療物質注入—輸液系統 内i時’遠裝置消減危險物質逸入環境内的可能性。 依據申請專利範圍第1項,此第一目的由具備一第一端及 一對向於1¾第一端之第二端的流體輸送裝置達成,其中該 第二端設計並排列為用來與輸液系統之一注入埠耦接。該 、一附接於該第一構件
障壁構件的撓性膜。 泥體輸送裝置包含至少一第—構件、 之中玄針頭,及一可以一容許
送裝置一同使用的藥瓶。 依據申請專利範圍第18項, 此第二目的由
由—裝有一固定 明之流體輸送裝 丄丄丄4 置的藥瓶。 私月〈一弔二目的為提出-種使用依據本發明、··力^ 心裝置在一輸液系統内進行流體輸送的方法。“ 裝m專利範園第25項,該方法包含使用1賴
-且將-順質經由—受—撓性障壁構件密封之注入辞 :入琢輸液系統内。因此,該流體輸送裝置包含至少一第 構件、-附接於該第-構件之中空針頭、及—可相對於 :::構件伸縮地移位的第二構件。該方法包含提供具有 端和-具備-撓性膜之第二對向端的流體輸送裝置 :提供:裝有-固定劑量酱療物質之藥瓶,將該第一端附 接於茲藥瓶,且將該第二端耦接於該注入埠同時以一足以 產生一雙重膜密封之壓力將該撓性膜壓抵於該撓性障壁構 件。該方法更包含藉由使該第一端以一朝往該第二端之方 向伸縮地移位讓該中空針頭在受該雙重膜密封包圍的同時 剌入茲撓性膜及該撓性障壁構件的方式產生一從該第一端 到这輸液系統之流體迴路,且藉由在該藥瓶内部產生且隨 後釋放一正壓的方式將該固定劑量物質從該藥瓶輸送至該 輸液系統内。 本發明之其他目的會在下文說明中顯露,且讓這些目的 得以達成之特徵列於附屬申請專利範圍項中。 【實施方式】 下文參照所附圖1至π更詳細地說明依據本發明流體輸 送裝置之一較佳實施例及數個替代實施例。 依據本發明之流體輸送裝置1 00, 200係欲用於輸液系統 S»% -1()- 1339114 中且具備—第—端10丨;201及一相反於該第一端之第二端 102; 202 ’其中該第二端丨〇2; 2〇2係設計排列為用以與輸液 系統】04; 204之一注入埠丨03; 203耦接。
依據本發明之流體輸送裝置1 00; 200包含至少一第一構 件丨〇:); 20^ ’ —附接於該第一構件之中空針頭1〇6, 2〇6,及 可以 i 5午中芝針頭1 〇 6; 2 0 6刺穿一密封注入埠1 〇 3 . 7 〇 3 之撓性障壁構件1 08; 208以造成一從第一端丨01; 2〇丨經由注 入埠1 03; 203進入輸液系統〗04; 204内之流體通路的方式相 對於第一構件205伸縮地位移的第二構件1〇7; 2〇7。 依據本發明,第一端丨01; 2〇丨具備一用來附接於一裝有一 固定劑量D醫療物質之藥瓶110; 210的連接部分1〇9; 2〇9; 309; 409。又中’’固定劑量(fixed d〇se)" 一辭應解釋為所述醫 療物質之一固定量,此量已針對目標患者作調整且此量是 要完全輸送至該輸液系統内。
此外’依據本發明,第二端]02;202具備—預期中在產生 該通入輸液系統1〇4; 204内之流體通路時以一足以產生一 圍繞中空針頭106; 206之雙重膜密封1〇8, lu;丨〇8 ?n 208, 2 1丨之壓力壓抵於注入埠1 〇3; 2〇3之撓性障壁構件丨 2 0 8的繞性膜1丨1; 2 1 1。 在一依據本發明流體輸送裝置之較佳實施例中’撓性膜 m; 211是由一在承受該壓力時呈現一降伏點的聚合物材 料製成’其巾第二端102; 202設計並排心料與注入淳 103; 203交互作用以將該壓力提高至該降伏點以上。如此確 保能夠達成一防漏密封。更佳為撓性膜丨丨丨;2丨丨與撓性障壁 839% -11 - 構件丨08,208是由會在相同壓力級達到其降伏點之相同材 料或相似材料製成。 最好該流體輸送裝置之第二端102; 202設計並排列為在 ~〉主入埠1 〇 3提供於輸液系統1 〇 4之一撓性輸液袋丨丨2上時 或者是在該注入埠已連接於一具備撓性障壁構件2 〇 8之獨 互歧路裝置S P時產生該雙重膜密封。較佳來說,該第二端 設計並排列為適用於所有情況。 在較佳實施例中,第二端I 〇2; 202設計並排列為用以產生 與注入璋1 〇 3搞接之雙重膜卡口。雙重膜卡口耦接本身可 從前文引述之美國專利第4,564,054號中得知。 在本發明之一第一較佳實施例中,如圖丨_4和8所示,連 接邵分109; 309具備用來抓住藥瓶1丨〇之一瓶頸部114以造 成一永久性連接的至少一個鎖定構件n 3; 3丨3,其中連接部 分丨09; 309更具備一用來刺穿藥瓶11〇之一瓶蓋Π6以將流 體1^路延伸至該藥瓶内的中空穿刺構件1 1 5。本實施例特別 適用於圖6所示類型的藥瓶/小藥瓶。 在本發明第—實施例中,如圖4所示,連接部分109具備 一用來刺牙藥瓶丨1〇之一瓶蓋丨丨6(圖6)以將流體通路延伸至 該藥瓶内的中空穿刺構件Π5。在本實施例中,如圖4所示 中工穿刺構件1 I )及中空針頭】〇6之相鄰末端設計並排列 為容許流體通過中空穿刺構件Π5進入中空針頭〗〇6。 、^曰代實把例中(圖中未示),該連接部分具備一用來刺 穿衣瓶&瓶Α以將流體通路延伸至該藥瓶内的中空穿剌 才,’、中及中空牙刺構件是由一暴露在流體輸送裝置第 • 12 - 1339114 -端《中空針頭一尖端構成。因此,圖4所示實施例中“且 件106和1丨5可由具備兩對向尖端之單一中空針頭取代。 在依據本發明流體輸送裝置之一第二實施例中如圆5 和7所示,連接部分2〇9具備一用來接合於—在藥瓶2⑺之一 瓶蓋2】6上提供之第二搞接構件217以藉由—魯厄鎖概接作 用造成連接的第一耦接構件2 ] 3。魯厄鎖耦接本身廣為人知 ’但是用在其他用途。
在第二實施例中,連接部分2〇9最好具備—用來附接於一 在藥瓶2丨0之一瓶蓋2丨6上提供之第二耦接構件2门的第一 耦接構件213’其中在一延伸於藥瓶21〇内血 件川間之導管2叫供-流體嶋㈣8 壁構件2丨8能由一外力弄破以使流體通路延伸至藥瓶2丨〇内 。因此在该第二實施例中’可弄破的流體障壁構件2 I 8提供 第一實施例中刺穿藥瓶瓶蓋116之穿刺構件丨15的功能。
在第一貫她例中,如圖5和7所示,連接部分2〇 9最好具備 —用來耦接於一至少部分地藉由一環狀囊構件22〇永久附 接於藥瓶210之第二耦接構件2n的第一耦接構件2〗3。然亦 可想見疏第一耦接構件以另一適當方式附接於藥瓶。 在第二實施例中,該連接部分最好具備一用來連接於一 在藥瓶2 1 0上提供之公頭魯厄鎖連接器222的母頭魯厄鎖連 接益22 ],或另一選擇為該連接部分具備一在藥瓶上提供之 母頭晋厄鎖連接器的公頭魯厄鎖連接器。 在依抓本發明冼體輸送裝置之第一較佳實施例中,如圖 2-4所π,涊連接郅分是一在永久性附接於藥瓶丨丨〇之前已 • 13 · 1339114 附接於第-構件m的獨立组件㈣。 在一特佳實施例中,兮速M却八^〜 分2〇9 4接β刀疋弟一構件205之一體部 ^ ra 所不另一避擇,圖3之组件ί〇5和丨〇9 可用半—組件取代。 且俨:代實她例中,如圖5和8所示’該連接部分是一 一 ,藉由—魯厄鎖竊接22丨,323附接於第一構件2〇5 站〜 接益323的獨立組件⑽。本實施例使得對不同 -瓶(例如圖6和7所示之兩類藥瓶)使 2〇〇成為可行。 土机"“谓运取且 替代實施例中,如圖9和】。所示,該連接部分是—
:、『用來错由-魯厄鎖耦接22丨,423附接於第一構件V 督厄鎖連接器423的獨立組件4〇9。 、 — 彺尽貫施例中,該連拉 刀更。備用來抓住藥瓶11 0之一瓶頸部以造成一永久性 伽至少-個鎖定構件4丨3’且具備—用來刺穿藥瓶丨丨。 :。瓶A以使流體通路延伸至該要瓶内的中空穿刺構件 _ 以下特別參照圖6-9說明依據本發明藥瓶之—較… 例及數個替代實施例。 ”她 依據本發明之藥瓶Π0; 2l〇裝有—固定劑量^
貨,其中藥瓶m;21〇預期中要附接於—依據本發明之心 輸送裝置100, 200 〇 L L 在-第-有利實施例中’如圖6所示’藥瓶11〇具備—預 期中讓連接部109之至少-鎖定構件Π3抓住以造成—永久 性連接的瓶頸部1丨4。較佳來說,如圖8和9所示,藥瓶"ο X39% -14 - 1339114 連接器2 2 2的瓶蓋2 1 6密封。另一選擇’藥瓶由一具備一預 期中要耦接於一連接部分公頭魯厄鎖連接器之母頭魯厄鎖 連接器的瓶蓋密封。 以下參照圖卜1 1更詳細說明依據本發明在一輸液系統内 進行流體輸送之方法的一較佳實施例及數個替代實施例。 該方法包含利用一流體輸送裝置1 00; 200將一醫療物質 經由一由一撓性障壁構件108密封之注入埠1 03注入輸液系 統1 〇4内。該流體輸送裝置包含至少一第一搆件丨〇5; 2〇5, 一附接於該第一構件之中空針頭1 06; 206,及一可相對於第 一構件105, 205伸縮地位移的第二構件107; 207。 依據本發明,該方法包含提供具有一第一端]0 1,2 0丨和一 具備一撓性膜1 1 1; 2 11之第二對向端1 02; 202的流體輪送裝 置’提供一裝有一固定劑量D醫療物質的藥瓶1 1 〇; 2 1 0,將 第一端】0丨;20丨附接於藥瓶丨丨0; 2丨0,且將第二端丨〇丨;20 1 槐接於注入埠丨〇 3同時以一足以產生一雙重膜密封| 〇 8, 1 1 1 ; 21 1之壓力將撓性膜1 1 1,21〗壓抵於撓性障壁構件 108° 此外’依據本發明’該方法包含藉由使第一端丨〇丨;2 〇】 以一朝往第二端丨〇2,202之方向伸縮地移位讓中空針頭 106; 206在受雙重膜密封1〇8, 1 1 1;】〇8, 21 1包圍的同時剌入 梭性膜丨I丨;2 1 1及撓性障壁構件^ 0 8的方式產生一從第一端 1 〇 1 ; 20 1到該輸液系統的流體通路,且藉由在藥瓶n 〇; 2丨〇 内部產生並隨後釋放一正壓的方式將固定劑量D從藥瓶 丨I 〇,2丨0輸送至輸液系統1 〇 4内。 • 16 · 839% 在較佳實施例中’該方法更包含將該壓力提高至構成 :,膜丨I丨,21丨之一聚合物材料的一降伏點以上。 最好主入蜂丨〇 3是在輪液系统1 〇 4之一撓性輸液袋丨1 2上 仏另一選擇’孩注入埠是在該輸液系統之一輸液流體 管線上提供。 ,在邊方法之較佳實施例中,第二端】〇2, 2〇2產生一與注入 崞1 03耦接之雙重膜卡口。 、r據本發明之一第—實施例中,該方法更包含藉由一 中上牙刹構件1丨3,3丨5刺穿藥瓶1 10之一瓶蓋116以使該流 L U路延伸至孩樂瓶内,且藉由流體輸送裝置1 00之至少一 鎖定構件1丨3抓住藥瓶丨丨〇之—瓶_丨丨4以造成—永久性 連接。 在衣據本务明方法之一替代實施例中,如圖5和7所示 此連接是藉由—魯厄鎖耦接22 1, 222造成。
、在依據本發明方法之另-實施例中,如圖7所示,在要 流體通路延伸至藥瓶21〇内時藉由一外力將一塞住一穿 瓶蓋2丨6之導管2丨9的流體障壁構件2丨8弄破。 在孩方法之-替代實施例中,如圖9所示,利用—央緊 件匚將夕卜壓砲加於一穿過瓶蓋的導管川上以插住通入 瓶内的流體㈣。此等夾緊構件的使用使得—輸液系統 二:组二有可能相互連接而沒有任何對環境的危險性漏 可-如沒有可弄破流體障壁構件或 統之流體容器的實施例。 “丨及 在另一替代實施例中,如圖I i所示,在該固定劑量從 S3 9% -17- 1339114 瓶2 10輸送到輸液系統204内之前將第二端之挽性膜丨取 抵於一連接至輸液系統204之一歧路裝置sp的撓性障壁構 件208。如圖Η所示,最好提供一夾緊構件〇以確保藥物能 從藥瓶2丨〇輸送到輸液流體容器2丨2内以在經由輸液管線l 開始輸液之前與輸液流體混合。 在依據本發明方法之另一較佳實施例中,如圖8簡略所示 ’流體輸送裝置包含在產生流體通路之前移除的至少—保 護蓋P。必要時得在依據本發明之流體輸送裝置及藥瓶的不 同4分上以及輸液系統之注入埠上提供數個保護蓋、罩、 密封件、或薄膜。此實施例確保會與輸液流體和所供應藥 物接觸之流體輸送系統表面能夠保持在—無菌狀態。 本文所述μ藥瓶(drug bottle)"—辭意指防漏且在其他方面 適於所要用途的任何容器。較佳來說,用於依據本發明之 總成中的’,藥瓶”僅有一開口且此開口由—封閉件或蓋子密 封,且其最好是由一固態、剛性且不可撓曲的材枓(例如玻 璃)製成。 在以上說明中已就數個特定實施例參照所附圖式說明本 各月。然本發明絕非僅只侷限於這些實施例或圖中所示, 本發明的範圍是由申請專利範圍定義。 Q此,如圖2-3和5所示,依據本發明之流體輸送裝置最 好具備一安全閂s控制第—構件丨05; 2〇5和第二構件⑺7; 207的伸縮動作。 【11式簡單說明】 乂上參照所附圖式更詳細地說明本發明,圖式中: S39lX> •18- 1339114 圖1為一輸液系統之局部簡圖,該系統内使用一依據本發 明之流體輸送裝置: 圏2為一依據本發明第一較佳實施例之流體輸送裝置的 透視簡圖; 圖3為圖2流體輸送裝置之分解圖; 圈4為圖2流體輸送裝置之内视圖: 圖3為一依據本發明第二實施例之流體輸送裝置的透視 簡圖; 圖6為一依據本發明第一實施例之藥瓶,其預期中是與圖 2流體輸送裝置一起使用; 圖7為依據本發明第二實施例之藥瓶,其預期中是與圖 5流體輸送裝置—起使用; 圖8出永久性地附接於一獨立連接部分之圖6藥瓶,其 具鈿軋由—魯厄鎖(Luer-lock)耦接作用附接於圖5流體 輸送裝置的魯厄鎖連接器; 圖9繪出永久性地附接於一依據本發明一替代實施例之 流體輸送裝置之一獨立連接部分的圖6藥瓶; 圖丨0為—輸液系統之局部簡圖,該系統内使用一依據本 發明一替代實施例之流體輸送裝置; 圖1 1繪出圖5流體輸送裝置及圖7藥瓶耦接於一替代輸液 系統之一歧路裝置。 【圖式代表符號說明】 |00^ 2〇〇 流體輸送裝置 101,201 第一端 83996 -19 - 1339114 102, 202 第二端 103,203 注入埠 104, 204 輸液系統 105, 205 第一構件 106, 206 中空針頭 107, 207 第二構件 108, 208 撓性障壁構件 4 109, 209, 309, 409 連接部分 • 110, 210 藥瓶 111, 211 撓性膜 1 12 撓性輸液袋 113, 313, 413 鎖定構件 1 14 瓶頸部 115, 315, 415 中空穿刺構件 116 瓶蓋 213 弟一搞接構件 • 216 瓶蓋 > 2 17 弟二稱接構件 2 18 流體障壁構件 219, 419 導管 220 環狀囊構件 221 母頭魯厄鎖連接器 222 公頭魯厄鎖連接器 323, 423 魯厄鎖連接器 839% -2()- 1339114 c 失緊構件 D 藥瓶内部 L 輸液管線 P 保護蓋 S 安全閂 SP 歧路裝置 839%
Claims (1)
- 第092106323號專利申請案 中文申請專利範圍替換本(99年11月)> + β 拾、申請專利範圍·_ 1. 一種用於輸液系統之流體輸送裝置,該流體輸送裝置 (100; 200)具備一第一端(101; 201)及一對向於該第一端 之第二端(102; 202),該第二端(102; 202)設計並排列為 用來與該輸液系統(104; 204)之一注入埠(1〇3; 203)耦接 ,該流體輸送裝置(1〇〇; 200)包含至少一第一構件(1〇5; 205)、一附接於該第一構件之中空針頭(1〇6; 206)、一 可以一容許該中空針頭(1 06; 206)刺穿一密封該注入埠 (1 03; 203)之撓性障壁構件(108; 208)以造成一從該第一 端(101; 2(H)經由該注入埠(103; 203)進入該輸液系統 (1 04; 204)内之流體通路的方式相對於該第一構件(1 〇5; 205)伸縮地位移的第二構件(1〇7; 207),其中該第一端 (1 0 1; 201)具備一用來附接於一裝有一固定劑量(D)醫 療物質之藥瓶(110; 210)的連接部分(1〇9; 209; 309; 409),且該第二端(1〇2; 202)具備一欲在產生通入該輸 液系統(1 04; 204)内之流體通路時以一足以產生一圍繞 該中空針頭(106; 206)之雙重膜密封〇〇8,111;丨〇8, 211; 208,211)之壓力壓抵於該注入埠(丨〇3; 2〇3)之該撓 性障壁構件(108; 208)的撓性膜(丨丨丨;2丨丨),其中該流體 輸送裝置係經構形以在傳輸一醫療物質進入一輸液流 體谷器及在將該流體輸送裝置自該輸液流體容器分離 之後之兩者過程中避免洩漏該醫療物質進入至該週遭 環境。 2.如申請專利範圍第1項之流體輸送裝置,其中該撓性膜 83996-991124.doc (HI; 211)是由一在承受該壓力時呈現一降伏點的聚合 物材料製A,且該第二端(1〇2; 2〇2)設計並排列為用來 與该〉主入璋(1 〇 3 )交互作用以將該壓力提高至該降伏點 以上。 3,如令請專利範圍第1項之流體輸送裝置,其中該第二端 U 02, 202)設計並排列為在該注入埠(1 〇3)提供於該輸液 系流(1 04)之撓性輸液袋(1 1 2)上時產生該雙重膜密封 (108, 111; 108, 211)。 4.如申請專利範圍第丨項之流體輸送裝置,其中該第二端 設計並排列為在該注入埠提供於該輸液系統之一輸液 體官線上或連接於一具備該撓性障壁構件(2〇8)之歧 路裝置(sp)時產生該雙重膜密封(2〇8, 211)。 5·如申請專利範圍第丨項之流體輸送裝置,其中該第二端 (102; 202)設計並排列為用來產生一與該注入埠(ι〇3)耦 接的雙重膜卡口。 6·如申請專利範圍第丨項之流體輸送裝置,其中該連接部 分(109; 309)具備用來抓住該藥瓶〇1〇)之一瓶頸部 (114)以造成一永久性連接的至少一個鎖定構件〇丨3; 313),且該連接部分(1〇9; 3〇9)更具備一用來刺穿該藥 瓶(110)之一瓶蓋(1丨6)以將該流體通路延伸至該藥瓶内 的中空穿刺構件(1 15)。 7.如申請專利範圍第丨項之流體輸送裝置,其中該連接部 分(1〇9)具備-用來刺穿該藥瓶("〇)之-瓶蓋(116)以 將該流體通路延伸至該藥瓶内的中空穿刺構件G丨5), 83996-991124.doc 1339114 且或中空穿刺構件(115)及該中空針頭(106)之相鄰末端 設計並排列為容許流體通過該中空穿刺構件(1 15)進入 中空針頭(106) 〇 8·如申請專利範圍第!項之流體輸送裳置,其中該連接部 分具備—用來刺穿該藥瓶之一瓶蓋以將該流體通路延 伸至該藥瓶内的中空穿刺構件,且該中空穿刺構件由一 暴露在該流體輸送裝置第一端之該中空針頭一尖端構 成。9. 如申請專利範圍第!項之流體輸送裝置,其中該連接部 分(2〇9)具備-用來接合於-在該藥瓶(210)之一瓶蓋 (216)上提供之第二&接構件(217)以藉由—魯厄鎖 (Luer lock)耦接器達成該連接的第一耦接構件pH)。10. 如申請專利範圍第!項之流體輸送裝置,其中該連接部 分(2〇9)具備-用來附接於—在該藥瓶(21G)之-瓶蓋 (216)上提供之第二耦接構件(217)的第一耦接構件 (213) ’其中-流體障壁構件(218)提供在—延伸於該藥 瓶(2 0)之内。卩(D)與該第二耦接構件(2 1 7)間之導管 ⑽)内且該流體障壁搆件(218)能由一外力弄破以使二 流體通路延伸至該藥瓶(2丨〇)内。 1 1.如申請專利範圍第1項 分(209)具備_用來耗接於—至少藉由_環狀囊 (220)永久性地附接於該藥瓶(2ι〇)之第二耦接 (2 17)的第一耦接構件(213)。 12.如申請專利範圍第i項之流體輸送裝置,其中該連 83996-99II24.doc 1339114 分具備-用來附接於_在該藥瓶(21〇)上提供之公頭魯 厄鎖連接器(222)的母頭魯厄鎖連接器(221)。 13·如申請專利範圍第1項之流體輸送裝置,其中該連接部 分具備-用來附接於一在該藥瓶上提供之母頭魯厄鎖 連接器的公頭魯厄鎖連接器。 14. 如申請專利範圍帛!項之流體輸送裝置,纟巾該連接部分為—在永久性連接於該藥瓶(11〇)之前已附接於該第 一構件(1 05)的獨立組件(1 〇9)。 15. 如申請專利範圍第〖項之流體輸送裝置,其中該連接部 分為第一構件(2〇5)之一體部分(2〇9)。 16·^申請專利範圍第1項之流體輸送裝置,其中該連接部 分為一具備一用來藉由一魯厄鎖耦接(221,323)附接於 該第一構件(205)之魯厄鎖連接器(323)的獨立組件 (309)。 1 7·如申請專利範圍第1項之流體輸送裝置,其中該連接部 分為一獨立組件(4〇9),其具備: • 一魯厄鎖連接器(423),其用來藉由一魯厄鎖耦接器 (22 1,423)附接於該第一構件(2〇5); -至少一鎖定構件(4〗3),其用來抓住該藥瓶(u〇)之 一瓶頸部(1 14)以產生一永久性連接;及 -一中空穿刺構件(4〗5),其用來刺穿該藥瓶(1 1〇)之 瓶蓋(1 1 6)以使该流體通路延伸至該藥瓶内。 18. —種用於輸液系統内之藥瓶,其中該藥瓶(ιι〇; 2丨〇)裝 有一固定劑量(D)之醫療物質,且該藥瓶(11〇;21〇)欲附 83996-991124.doc -4- ⑶ 9114 置(100; 接於一如申請專利範圍第】項之流體輸送裝 200) 〇 、 19.如中請專利範圍第18項之藥瓶,其t該藥瓶(m)且備. -欲讓該連接部分〇09)之至少—鎖定構件⑴3)抓住以 產生—永久性連接的瓶頸部(u 4)。 2〇.=申請專利範圍第18項之藥瓶,其㈣藥瓶⑴〇)具備 一欲由—為該流體輸送裝置_)-部分之穿剩構件 (Π5; 315)刺穿的瓶蓋(116)。 21. 如中請專利範圍第18項之_,其中該藥瓶⑽)由— 具備-欲附接於該連接部分(2〇9)一第一耦接構件⑺3) 之第二耦接構件(217)的瓶蓋(216)密封。 22. 如申請專利範圍第18項之藥瓶,其中該藥瓶(2⑼由一 f備H接構件(217)之瓶蓋(216)密封,且一流體 P早i構件(2 18)提供在一延伸於該藥瓶⑺〇卜内部⑼ 與該第二1¾接構件(217)間之導管(219)内,且該流體障 壁構件(218)能由一外力弄破以使該導管(219)打開。 23·如申請專利範圍第18項之藥瓶,其中該藥瓶(21〇)由一 具備—欲附接於該連接部分()一第-搞接構件(213) 之第二耦接構件(217)的瓶蓋(216)密封,其中該第二耦 妾構件(2 1 7)至少部分地藉由一環狀囊構件永久性 附接於該藥瓶(2 1 〇)。 24.如申凊專利範圍第18項之藥版其中該藥瓶(21〇)由一 、備奴附接於該連接部分(209) 一母頭魯厄鎖連接器 (221)之公頭魯厄鎖連接器(222)的瓶蓋(21 6)密封。 83996-991124.doc 1339114 25.如申請專利範圍第18項之藥瓶,其中該藥瓶由一具備— 欲附接於該連接部分一公頭魯尼鎖連接器之,頭魯厄 鎖連接器的瓶蓋密封。 2 6 · —種在輸液系統内進行流體輸送之方法,該方法包含使 用一流體輸送裝置(1〇〇; 200)將一醫療物質經由一受— 撓性障壁構件(1 08)密封之注入埠(1 03)注入該輸液系統 (104)内,該流體輸送裝置包含至少一第一構件(1〇5; 205)、一附接於該第一構件之中空針頭(1〇6丨2〇6)、及 一可相對於該第一構件(1 〇5; 205)伸縮地並可縮回地移 位的第二構件(1 07; 207),其中該方法包含: -提供具有一第一端(1〇1; 201)和—具備一撓性膜 (111; 211)之第二對向端(1〇2; 202)的該流體輸送裝置 (100; 200); -提供一裝有一固定劑量(D)之該醫療物質的藥瓶 (110; 210); -將該第一端(1 〇 1; 201)附接於該藥瓶(u 〇; 2丨〇); -將忒第一端(1 〇 1; 201)搞接於該注入蟑(1 〇3)同時以 一足以產生一雙重膜密封(108, 111; 1〇8, 2 n)之壓力將 該撓性膜(m; 211)壓抵於該撓性障壁構件(丨〇8); -藉由使該第—端U 0 1; 20 1)以一朝往該第二端(丨〇2·, 202)之方向伸縮地移位讓該中空針頭(1〇6; 2〇6)在受該 雙重膜密封(108, 111; 108, 211)包圍的同時刺入該撓性 膜(111; 211)及該撓性障壁構件(1〇8)的方式產生一從該 第一端(101; 201)到該輸液系統之流體通路;且 83996-991124.doc 1339114 藉由在該藥瓶(110; 21 〇)内部產生並隨後釋放一正 1的方式將該固定劑量(D)從該藥瓶(11〇; 2〗〇)輸送至 該輸液系統(1〇4)内。 27. 28. 29. 30. 31. 32. 33. 34. 如申請專利範圍第26項之流體輸送方法,其中該方法包 a將忒壓力提鬲至一建構該撓性膜(111; 2 η )之聚合物 材料之一降伏點以上。 如申請專利範圍第26項之流體輸送方法,其中該注入璋 (03)位在忒輸液系統(1〇4)之一撓性輸液袋(I。)上。 如申請專利範圍第26項之流體輸送方法,其中該注入璋 位在該輸液系統之一輸液流體管線上。 如申請專利範圍第26項之流體輸送方法,其中該第二端 (02, 202)產生一與該注入埠(1〇3)耦接之雙重膜卡口。 如申請專利範圍第26項之流體輸送方法,其中該方法更 包含: 藉由一中空穿刺構件(115;3 15)刺入該藥瓶(11〇)之 一瓶盍(116)以使該流體通路延伸至該藥瓶内;且 •藉由該流體輸送裝置(100)之至少一鎖定構件(113) 抓住該之-瓶頸部⑴4)以造成—永久性連接。 如申請專利範圍第26項之流體輪送方法,其中該連接是 藉由一魯厄鎖耦接(221; 222)造成。 如申請專利範圍第26項之流體輸送方法,其中一擋住一 牙過忒瓶蓋(2丨6)之導管(2丨9)的流體障壁構件(21 8)在將 該流體通路延伸至該藥瓶(21G)㈣由—外力弄破。 如申請專利範圍第26項之流體輸送方法,其中利用一央 83996-99H24.doc 1339114 緊構件(C)在一穿過該瓶蓋之導管(419)上施加一外壓以 阻擋該流體通路進入該藥瓶。 3·5.如申請專利範圍第26項之流體輸送方法,其中使該第二 立而之撓性膜(211)在將該固定劑量從該藥瓶(2 1 〇)輸送至 該輸液系統(204)内之前壓抵於—連接於該輸液系統 (2〇4)之-歧料置(sp)的—撓性_構件⑽ I =2範固第26項之流體輪送方法,其中該流體輪 =置包含在造成該流體通路之前移除之至少一保護蓋83996-991124.doc
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-
2002
- 2002-04-17 US US10/063,386 patent/US7867215B2/en active Active
-
2003
- 2003-03-21 TW TW92106323A patent/TWI339114B/zh not_active IP Right Cessation
- 2003-04-09 WO PCT/SE2003/000573 patent/WO2003086530A1/en active Application Filing
- 2003-04-09 AU AU2003222550A patent/AU2003222550A1/en not_active Abandoned
- 2003-04-09 JP JP2003583539A patent/JP4731118B2/ja not_active Expired - Lifetime
- 2003-04-09 ES ES19183618T patent/ES2934415T3/es not_active Expired - Lifetime
- 2003-04-09 EP EP03717852.2A patent/EP1494748B1/en not_active Expired - Lifetime
- 2003-04-09 EP EP19183618.8A patent/EP3569217B1/en not_active Expired - Lifetime
- 2003-04-09 ES ES03717852T patent/ES2748462T3/es not_active Expired - Lifetime
Also Published As
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ES2748462T3 (es) | 2020-03-16 |
EP1494748B1 (en) | 2019-09-04 |
EP1494748A1 (en) | 2005-01-12 |
ES2934415T3 (es) | 2023-02-21 |
TW200404511A (en) | 2004-04-01 |
JP2005522282A (ja) | 2005-07-28 |
US20030199847A1 (en) | 2003-10-23 |
EP3569217B1 (en) | 2022-10-05 |
WO2003086530A1 (en) | 2003-10-23 |
EP3569217A1 (en) | 2019-11-20 |
US7867215B2 (en) | 2011-01-11 |
JP4731118B2 (ja) | 2011-07-20 |
AU2003222550A1 (en) | 2003-10-27 |
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