TWI801546B - 用於藉由輸液或注射給予患者的流體藥用或營養物質的劑量重組之具有壓力補償器的無菌軟性包裝 - Google Patents

用於藉由輸液或注射給予患者的流體藥用或營養物質的劑量重組之具有壓力補償器的無菌軟性包裝 Download PDF

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TWI801546B
TWI801546B TW108111332A TW108111332A TWI801546B TW I801546 B TWI801546 B TW I801546B TW 108111332 A TW108111332 A TW 108111332A TW 108111332 A TW108111332 A TW 108111332A TW I801546 B TWI801546 B TW I801546B
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保羅朱塞普 戈比弗拉帝尼
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瑞士商艾迪安納製藥及生物科技股份有限公司
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Abstract

該包裝包含一無菌袋(3)、一瓶(9)及一管(12)，該無菌袋(3)填充有液體稀釋劑，該瓶(9)配備有一可刺穿蓋件(26)，用於容納一藥用或營養物質，該管(12)係從該袋延伸且以用於該瓶的蓋件的一耦接穿孔裝置(16)為末端。該袋係容納在一第一軟性無菌密封殼體(1)中，而該瓶(9)及該耦接穿孔裝置係容納在第二軟性無菌密封殼體(2)中。該管(12)具有位於該第一軟性無菌密封殼體(1)及該第二軟性無菌密封殼體(2)之間的一中間部分(13)，在該中間部分(13)中容納一分流器(18)，該分流器可以從第一位置調整至第二位置或第三位置，在該第一位置，該分流器阻止該瓶與該袋之間的任何連通，在該第二位置，該分流器允許該袋與用於一注射器(22)的一密封側開口(19)連通，在該第三位置，該分流器允許該瓶與該側開口連接。具有疏水過濾器(43)的一軟性管(42)係附接至該分流器的另一側開口(41)，終止於該第一無菌密封殼體(1)及該第二軟性無菌密封殼體(2)中的一者及/或另一者且作為一壓力補償器之用。

Description

用於藉由輸液或注射給予患者的流體藥用或營養物質的劑量重組之具有壓力補償器的無菌軟性包裝
本發明係有關一種無菌軟性包裝，用於藉由輸液或注射給予患者的流體藥用或營養物質的劑量重組。該包裝係配備有一壓力補償器，以在重組期間將施加在流體上的壓力保持為固定。
用於靜脈內輸液或滴注的包裝是已知的，該包裝包含軟性袋，其中形成用於容納稀釋劑的無菌腔室，且具有可打開封蓋的軟性管從該軟性袋延伸，配備有耦接穿孔裝置，經由該耦接穿孔裝置將呈粉末、凝膠或其他材料的藥用或營養物質從瓶中抽出且將其輸送至袋的內腔室中，該物質一旦與稀釋劑混合時就形成擬供應給患者的藥物或營養素。
一旦瓶被穿孔以便將藥用或營養物質從瓶轉移到袋中，就必須保持無菌狀態，這也是已知的。
雖然無菌性損失總是危險的，但在高風險藥物之特定情況下，此損失可能對患者及負責患者照護的醫療及保健人員都造成嚴重影響。首先，存在正執行錯誤施用的危險，例如由於藥物重組的過早或錯誤觸發，或者醫療及保健人員或患者自身的污染風險。
已知作為此問題之解決方案的包裝，其中具有氣密封蓋的單個無菌軟性殼體容納在分開的腔室中、具有液體稀釋劑的軟性袋、以及呈粉末、凝膠或其他形式的藥用或營養物質的瓶且配備有可刺穿蓋件，尤其是從EP 2962676 A1。該殼體也容納混合管，該混合管配備有可打開封蓋，其自該袋延伸並以允許耦接至該蓋件且將該蓋件穿孔的裝置為末端。最初地，該瓶在對於耦接穿孔裝置的耦接位置上被插入至殼體的(仍然打開的)腔室中，且接著在該腔室已經被氣密密封之後，其經由耦接穿孔裝置本身可以從殼體外部手動地操縱直到該蓋件的穿孔位置。
因此，軟性袋、具有藥用或營養物質的瓶、以及用於混合兩種產品且重組所欲藥物或營養素的耦接穿孔裝置，仍留在密封的無菌殼體內，確保實施及維持完全無菌狀態。
根據EP 3158987 A1中敘述的變型，軟性殼體中容納瓶的部分可以配備有具有可打開及可氣密密封蓋件的連接器，經由該連接器，消毒氣體及氧氣的混合物可以流入至殼體的該部分，因此確保瓶及整個包裝的甚至更高的無菌性。
然而，上述兩種解決方案都侷限於包含瓶中所含有藥用或營養物質總量之藥物或營養素的重組，且不允許任何的分劑。
當所欲或甚至需要將一劑量的藥用或營養物質與袋中所含有的稀釋劑混合以形成具有可變但精確劑量的物質的最終藥物或營養素時，此種限制使得上述兩種包裝完全無用。
另一方面，從EP 2399565 A1已知一種利用液體稀釋劑將無菌袋中的藥物或營養素作劑量重組之裝置，其中呈粉末、凝膠或其他材料的藥用或營養物質係以一劑量從瓶中抽出，該瓶設置有可被鉤住及穿孔的蓋件。
該裝置包含三通分流器，藉由例子類似於活栓，其容納在從軟性袋延伸的管的一半，且以用於該瓶的蓋件的耦接穿孔裝置為末端。
當調整至第一位置時，分流器阻止瓶與袋之間的任何連通，而當移動至第二位置時，分流器允許袋與用於注射器或其他柱塞裝置的側開口連通，且當旋轉至第三個位置時，分流器允許瓶與該側開口連接。
然而，在蓋件經由從袋延伸的管的耦接穿孔裝置穿孔時，或是在耦接及移除注射器時，上述解決方案不能確保瓶的無菌性。
最後，從申請人名下於2016年6月7日提交的實用新型第202016000058207號義大利專利申請案中已知一種無菌軟性包裝，其包含一無菌袋、一瓶及一管， 該無菌袋填充有液體稀釋劑，該瓶配備有可刺穿蓋件，用於容納呈粉末、凝膠或其他材料的藥用或營養物質，該管從該袋延伸且設置有用於該瓶的蓋件的耦接穿孔裝置，其中該袋係容納在一軟性、無菌及密封殼體中，該瓶及該耦接穿孔裝置係容納在第二軟性、無菌密封殼體中。該等殼體係為分離的且是間隔開的，且該管具有位於該第一及該第二殼體之間的一部分，在該部分中容納有一可調整分流器，該分流器可以被調整至第一位置、第二位置或第三位置，在該第一位置，防止該瓶及該袋連通，在該第二位置，該袋係與用於一注射器或其他柱塞裝置的一可打開且可氣密密封的側開口連通，在該第三位置，該瓶係與該側開口連通。
藉由此包裝，首先使用注射器柱塞從袋中抽出稀釋劑且將其插入至瓶中，以將稀釋劑與瓶中所含有的物質混合，且接著從瓶中抽出一劑量的混合物且將其插入至留在袋內的液體稀釋劑中，藥物或營養素可以以任何所欲劑量被重組及施用，且適合於患者的治療。
本發明之目的在於改進該包裝，以避免由於在插入至瓶時由注射器柱塞首先施加壓力在從袋中抽出的稀釋劑上所引起的可能問題，及在插入至留在袋內的稀釋劑時接著施加壓力在從瓶中抽出的劑量混合物上引起的問題。
根據本發明，藉由配備有壓力補償器的包裝來實現上述目的，該壓力補償器係由具有疏水過濾器的 小管組成，疏水過濾器將分流器中面向針對注射器設計之一者的另一側通路連接至該等無菌及密封殼體中的一者或另一者。
在此方式，藉由推動注射器柱塞而首先施加在液體稀釋劑上且接著施加在劑量混合物上的壓力被釋放到該等殼體中的一者或另一者中，因此避免過壓問題。
1:第一軟性無菌密封殼體
2:第二軟性無菌密封殼體
3:無菌袋
4:稀釋劑
5:軟性輸入管
6:軟性輸出管
7:蓋件
8:蓋件
9:瓶
10:藥用或營養物質
11:管連接器
12:管
13:中間部分
14:最後部分
15:易碎封蓋
16:耦接穿孔裝置
17:翼片
18:分流器
19:側開口
20:可打開及可氣密密封蓋件
21:魯爾
22:注射器
23:柱塞
24:混合物
25:藥物或營養素
26:可刺穿蓋件
27:氣密打開/關閉蓋件
28:穿孔尖端
41:另一側開口
42:軟性管
43:疏水過濾器
50:易碎封蓋
51:初始部分
藉由以下參照附圖對本發明實施例的詳細敘述，本發明之特徵將變得顯而易見，附圖僅作為非限制性例子提供，其中：第1圖係顯示根據本發明且隨時可用的無菌及密封包裝；第2至5圖係顯示在藉由注射器所執行的抽出、混合及重組程序之期間的相同包裝；第6圖係顯示程序完成後的包裝；第7圖係為具有疏水過濾器的管的一端之放大比例剖視圖，該管作為壓力補償器之用。
第1圖係顯示不同的第一軟性無菌密封殼體1及第二軟性無菌密封殼體2，其為對準但間隔開的。
第一軟性無菌密封殼體1係容納軟性無菌袋3，無菌袋3填充有適合的液體稀釋劑且配備有軟性輸入管5及軟性輸出管6，輸入管5及輸出管6兩者設置有蓋件7及8。
第二軟性無菌密封殼體2係容納一瓶9，瓶9 具有呈粉末、凝膠或其他液體材料的藥用或營養物質10。瓶通常係用蓋件26來密封。蓋件26係為EP 2867132 A1中敘述的類型之蓋件，且可以藉由利用注射器、魯爾或其他刺穿裝置穿孔而打開，且一旦移除穿孔裝置時就可以自動地氣密密封。第二軟性無菌密封殼體2也設置有管連接器11，管連接器11具有EP 2867132 A1中所述類型的氣密打開/關閉蓋件27。管連接器11可以使用於將臭氧或其他消毒氣體及氧氣的混合物輸送至殼體2中。
袋3及瓶9係藉由軟性管12連接，軟性管12係由初始部分51、中間部分13、及最後部分14所組成，初始部分51從袋3延伸且延伸出第一軟性無菌密封殼體1且包括已知類型的易碎封蓋50，中間部分13將第一軟性無菌密封殼體1連接至第二軟性無菌密封殼體2，最後部分14係容納在第二軟性無菌密封殼體2內且包含已知類型的易碎封蓋15，且最終以EP 2962676 A1中所述類型的耦接穿孔裝置16為末端。該耦接穿孔裝置係配備有翼片17及穿孔尖端28，翼片17可以耦接至瓶9的蓋件26，穿孔尖端28用於在該蓋件已經耦接至翼片17之後及已經經由施加在第二軟性無菌密封殼體2的外壁上之壓力作另一軸向移動之後，刺穿瓶9的蓋件26，以使瓶9更靠近袋3，如EP 2962676 A1中進一步詳細敘述的。為簡單起見，第1圖中的瓶9已經穿孔且處於耦接位置，但易碎元件15仍顯示為處於關閉位置。
位於第一軟性無菌密封殼體1及第二軟性無 菌密封殼體2之間的軟性管12的中間部分13包含分流器18，藉由例子係為四通活栓，其中側開口19係用蓋件20來封閉，蓋件20可以利用具有柱塞23之注射器22的魯爾21(帶針或不帶針)來穿孔且一旦移除魯爾21就自動地密封。分流器18的另一側開口41係連接至具有疏水過濾器43(第7圖)的軟性管42，其終止於第一軟性無菌密封殼體1及第二軟性無菌密封殼體2中的一者或另一者，如第1圖中分別以連續線及點劃線所示者。為了簡單起見且純粹藉由例子，第2至6圖僅係顯示管22暫時地插入至袋3的殼體1中。
第1圖係顯示分流器18處於管12及側開口19都完全地關閉的位置。
為了觸發袋3內的藥物或營養素的重組，將分流器18調整至第2圖所示的位置，因此使袋及側開口19連通，且接著將魯爾21插入至蓋件20中以便將其穿孔。一旦易碎封蓋50破裂，最初處於完全向前位置的注射器柱塞23被向後拉動，以從袋3中抽出所欲量的稀釋劑4。
接著，將分流器18朝上旋轉至第3圖所示的位置，因此使最後部分14在已插入魯爾21時與側開口19之間能夠連通。藉由破壞易碎元件15且向前推動注射器22的柱塞23，可以將稀釋劑先前抽出的量轉移到瓶3中，其中該稀釋劑係與其中包含的藥用或營養物質10混合，且因此形成混合物24。在此階段，具有疏水過濾器43的軟性管42作用成終止於無菌殼體的壓力補償 器，因而避免對專業處理該包裝及注射器以及接收流體混合物質的患者的任何可能的毒性污染物。
藉由如第4圖所示向後拉動柱塞23，將所欲量的混合物24吸入至注射器22中，一旦分流器18旋轉至第5圖所示的位置時(與第2圖相同)，可以藉由向前推動柱塞23將該混合物輸送至袋3中且因此產生具有所欲劑量的藥物或營養素25。同樣在此階段，具有疏水過濾器43的軟性管42係作用成終止於無菌殼體中的壓力補償器。
如第6圖所示最後地調整分流器18，且同時注射器22的魯爾21仍然在蓋件20內。
藥物或營養素的劑量重組之過程係完成，且為了將該藥物或營養素供應給患者，可以打開蓋件8(第6圖)。
1:第一軟性無菌密封殼體
2:第二軟性無菌密封殼體
3:無菌袋
4:稀釋劑
5:軟性輸入管
6:軟性輸出管
7:蓋件
8:蓋件
9:瓶
10:藥用或營養物質
11:管連接器
12:管
13:中間部分
14:最後部分
15:易碎封蓋
16:耦接穿孔裝置
17:翼片
18:分流器
19:側開口
20:可打開及可氣密密封蓋件
21:魯爾
22:注射器
23:柱塞
26:可刺穿蓋件
27:氣密打開/關閉蓋件
28:穿孔尖端
41:另一側開口
42:軟性管
43:疏水過濾器
50:易碎封蓋
51:初始部分

Claims (6)

  1. 一種無菌軟性包裝，包含：一無菌袋(3)，填充有液體稀釋劑；一瓶(9)，具有一可刺穿的蓋件(26)，以容納呈粉末、凝膠或液狀的一藥用或營養物質；一管(12)，係從該袋(3)延伸且以配置在該瓶(9)的蓋件(26)的一耦接穿孔裝置(16)為末端；一第一軟性無菌密封殼體(1)，該第一軟性無菌密封殼體(1)收容該袋(3)；一第二軟性無菌密封殼體(2)，該第二軟性無菌密封殼體(2)收容該瓶及該耦接穿孔裝置，其中該第一軟性無菌密封殼體(1)及該第二軟性無菌密封殼體(2)係在空間上分離一距離，且該管(12)具有在該第一軟性無菌密封殼體(1)及該第二軟性無菌密封殼體(2)之間延伸的一中間部分(13)；一可調整分流器(18)，配置在該管(12)的該中間部分(13)，其中該可調整分流器(18)係構造成被調整至：第一位置，其中該分流器(18)阻止該瓶(9)與該袋(3)之間的連通；第二位置，其中該分流器(18)允許該袋(3)與該分流器(18)的一第一側開口(19)連通，且該第一側開口(19)包含用於承接一注射器(22)的一可打開及可氣密密封蓋件(20)；及第三位置，其中該分流器(18)允許該瓶(9)與該分流器(18)的該第一側開口(19)連通；以及 一壓力補償器，包含具有疏水過濾器(43)的一軟性管(42)，該軟性管(42)係連接至該分流器(18)的第二側開口(41)，且終止於該第一軟性無菌密封殼體(1)或該第二軟性無菌密封殼體(2)。
  2. 如請求項1之無菌軟性包裝，其中該分流器(18)包含一四通活栓。
  3. 如請求項1或2之無菌軟性包裝，其中該耦接穿孔裝置(16)包含多個翼片(17)及一穿孔尖端(28)，該等翼片(17)係構造成耦接至該瓶(9)的蓋件(26)，該穿孔尖端(28)係構造成在該蓋件(26)已經耦接至該等翼片(17)且壓力已經被施加在該第二軟性無菌密封殼體(2)的外壁上之後，刺穿該瓶(9)的蓋件(26)，以使該瓶(9)沿著該管(12)在軸方向更靠近該袋(3)。
  4. 如請求項1或2之無菌軟性包裝，其中該第二軟性無菌密封殼體(2)包含一管連接器(11)，該管連接器(11)係構造成將臭氧及氧氣的一混合物輸送至該第二軟性無菌密封殼體(2)中。
  5. 如請求項1或2之無菌軟性包裝，其中在該管(12)的該中間部分(13)與該耦接穿孔裝置(16)之間，該管(12)包括容納一易碎封蓋(15)的一最後部分(14)。
  6. 如請求項1或2之無菌軟性包裝，其中該管(12)包括從該第一軟性無菌密封殼體(1)延伸且終止於該袋(3)的一初始部分(51)，且該管(12)的初始部分(51)容納一易碎封蓋(50)。
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