TWI783979B - 治療性血漿置換術用之裝置 - Google Patents
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Abstract
本發明揭示一種治療性血漿置換術用之裝置,其包含體外迴路,前述體外迴路包含血液供給線路、分離單元、有形成分輸注用之線路、替換流體輸注用之線路、血液血漿線路、抗凝血劑線路以及至少一個獨立的治療性藥物用之線路。
Description
本發明係關於醫療裝置領域,且特定而言係關於一種治療性血漿置換術用之裝置,其允許治療性藥物之施用與血漿置換術程序之執行同時發生且獨立於替換流體之施用。
治療性血漿置換術(Therapeutic Plasma Exchange;TPE)形成被稱為血漿除去法之較大技術群組之部分。在血漿除去法中,血液自人體抽出且以使血漿與血液之主要有形成分(紅血球、白血球、血小板等等)分離之方式進行處理。目前,出於多種原因使用血漿除去法,包含輸血、用於後續分級分離且獲得血液衍生物之血漿捐獻,或藉由自血液血漿移除特定針對疾病之因子進行治療之疾病治療。
TPE係指示為諸多疾病之治療之特定類型之血漿除去法,其中為了自患者之血液移除有害物質而丟棄已與有形成分之剩餘部分分離之血漿。已經分離之有形成分通常與被稱為替換流體之液體混合且返回給患者。最常見替換流 體包含等滲壓鹽溶液、白蛋白膠體溶液或新鮮血漿等等。為避免血壓過低或周邊水腫,較佳係供給基於能夠維持膠體滲透壓之白蛋白膠體溶液或新鮮血漿之替換流體。在大多數情形下,等滲壓鹽溶液中4-5%之白蛋白係作為替換流體之較佳選項,此係由於與新鮮血漿相反,其不特定針對特定血型且呈現較小過敏性反應風險。
使用TPE技術引起之主要風險中之一者係歸因於大部分血漿蛋白諸如凝血因子、轉運蛋白、補體系統之蛋白、以及抗體及特定而言免疫球蛋白G之濃度減小。出於此原因,通常在完成血漿置換術過程之後必需施用,其目標尤其係重新平衡患者血漿蛋白之正常位準(normal levels)。該施用通常採用靜脈內、肌內或皮下途徑等等。
需要如下之TPE裝置:允許與執行血漿置換術程序同時地施用一或多種治療性藥物,以此方式使得有可能尤其在進行血漿置換術程序之時間期間維持患者之血漿蛋白的位準,而不必在等到其結束後進行重新平衡。
先前技術中已知之TPE裝置僅允許在治療性藥物溶於替換流體之情形下施用該治療性藥物。此涉及各種問題及其對患者健康帶來之風險,其中尤其係替換流體之操作風險或獨立於替換流體流速控制治療性藥物流速之不可能性,等等。
用於血漿除去法或血漿置換術之裝置在先前技術中係已知的。舉例而言,美國專利US5679245A揭示一種用於體外血液處理之設備,其包含過濾單元、初級迴路及次級迴路。該專利亦揭示一種抗凝血劑流體線路及替換流體線路,其集中在初級迴路上。
先前技術中已知之TPE裝置之另一缺陷係其大尺寸且難以攜帶,此意指患者必須去醫療中心接收治療。因而需要一種克服先前技術之裝置之缺陷之TPE裝置。
本發明之發明人已開發出克服上述問題且由於某些原因令人驚奇之TPE裝置。在該等原因中,本發明之發明人可述及:施用治療性藥物與血漿置換術程序同時發生且獨立於施用替換流體之可能性,以及改良之可攜性。
在本發明文獻中,術語「體外迴路(extracorporeal circuit)」係指多個獨立的TPE裝置之線路之組合。
在本發明文獻中,術語「線路」或「獨立的線路」係指選自以下之結構元件之組合:液體傳送構件、液體推進構件、液體流量控制構件、液體儲存構件等等,其共同執行TPE裝置中之特定功能。術語「線路」不指結構元件之最小組合,例如在一些情形下,線路可由傳送構件及儲存 構件組成,而在其他情形下,線路可由傳送構件、儲存構件、推進構件等等組成。此外,若干線路可共用一或多個結構元件。線路之實例係如下述。
-血液供給線路或供給線路:係指允許患者血液自抽出區傳送至分離單元之入口之結構元件之組合。
-有形成分輸注用之線路或有形成分線路:係指允許有形成分自分離單元之出口傳送至輸注區之結構元件之組合。
-替換流體輸注用之線路或替換流體線路:係指允許替換流體自替換流體容器傳送至輸注區之結構元件之組合。
-血液血漿線路或血漿線路:係指允許血液血漿自分離單元之血漿出口傳送至血液血漿容器之結構元件之組合。
-抗凝血劑線路:係指允許抗凝血劑流體自抗凝血劑液體容器傳送至供給線路之結構元件之組合。
-治療性藥物輸注用之線路或治療性藥物用之線路:係指允許治療性藥物自治療性藥物容器傳送至輸注區之結構元件之組合。
在本發明文獻中,術語「液體傳送構件」或「傳送構件」係關於諸如管道、線路、管路等允許液體經由其內部通道在兩個點之間傳送之元件。
術語「液體推進構件」或「推進構件」係指能夠傳遞能量至液體以達成其經由傳送構件之移動之任何元件。在 本發明中,該推進構件較佳地係泵,且更佳地係蠕動泵。
術語「液體流量控制構件」或「流量控制構件」係指能夠阻止/允許或調節液體經由傳送構件之傳送之任何元件。在本發明中,該流量控制構件較佳地係閥及/或蠕動泵。
對於熟習此項技術者將顯而易見的是同一個元件有時可執行推進構件及流量控制構件之功能,例如蠕動泵可執行此兩者之功能。對於熟習此項技術者亦將顯而易見的是可藉由集中控制單元以電子方式控制推進構件及流量控制構件。
術語「液體儲存構件」、「儲存構件」或「容器」在本發明中同義使用,係指允許液體容納於其中並連接至傳送構件之任何元件。該儲存構件較佳地係:瓶、小瓶、塑膠袋等等,其組合。對於熟習此項技術者將顯而易見的是儲存構件可具有出口及/或入口,此取決於其在體外迴路中執行之功能。對於熟習此項技術者亦將顯而易見的是可藉由流量控制構件控制該儲存構件之入口及/或出口。
術語治療性藥物係指熟習此項技術者已知之任何治療性液體。較佳地,該治療性藥物包含選自由以下組成之群組之人類血漿蛋白:白蛋白(5-25%)、α1抗胰蛋白酶、馮威裡氏(von Willebrand)因子、諸如凝血因子VII、凝血因 子VIII及凝血因子IX之凝血因子、免疫球蛋白、纖溶酶原(plasminogen)、纖溶酶(plasmin)、抗凝血劑酶III、纖維蛋白原(fibrinogen)、纖維蛋白(fibrin)、凝血酶(thrombin)或其組合。
術語「血液」係關於全血,亦即含有血液之所有有形成分,諸如除血漿之外亦有紅血球、白血球、血小板等。
術語「血液血漿」或「血漿」係指血液之無細胞液體部分。
術語「分離單元」係指能夠將血液分離成其對應之細胞及無細胞部分之任何裝置。在本發明文獻中,該等部分亦分別被稱為有形成分與血漿。
因此,本發明揭示一種TPE裝置,其包含體外迴路,該體外迴路包含血液供給線路、分離單元、有形成分輸注用之線路、替換流體輸注用之線路、血液血漿線路、抗凝血劑線路以及至少一個獨立的治療性藥物用之線路。
該獨立的治療性藥物用之線路包含至少一個治療性藥物容器、傳送構件、推進構件及該治療性藥物之流量控制構件。較佳地,該獨立的治療性藥物用之線路之該等推進 構件係至少一個蠕動泵,更佳地,該蠕動泵係可逆蠕動泵。
在本發明之另一方面中,本案發明人已簡化一種TPE裝置,其包含至少一個治療性藥物用之線路,藉此有可能獲得包含至少一個治療性藥物用之線路之可攜式TPE裝置。該裝置之該簡化藉由以下達成:除至少一個治療性藥物用之線路之外,先前技術中已知之線路(替換流體線路、有形成分線路、供給線路等等)中之若干者亦共用結構元件(傳送構件、推進構件、流量控制構件等等)。
在一個實施例中,本發明之裝置之治療性藥物用之線路與該裝置之其他線路中之一或多者共用結構元件。較佳地,該等共用之結構元件係傳送構件、推進構件及流量控制構件。在較佳實施例中,該等共用之推進構件係至少一個可逆蠕動泵。在另一較佳實施例中,該等共用之流量控制構件係徑向分配器。
術語「徑向分配器」係指諸如在西班牙專利ES 2255772 B1(Grifols Lucas,V.)中揭示之分配器類型。該分配器具有與分配器之共同中心點連通且可藉由整合至該徑向分配器中之流量控制構件之操作而置於彼此連通中之若干線路。可藉由集中控制單元自動地控制該操作。
本發明之裝置具有患者血液抽出區及患者輸注區,該 等區亦被簡稱為抽出區與輸注區。在本發明之一些實施例中,抽出區與輸注區並非裝置之重合區,而在其他實施例中,抽出區與輸注區係裝置之重合區。
在本發明之一個實施例中,分離單元係過濾器。在較佳實施例中,該過濾器係中空纖維過濾器。
在本發明之一個實施例中,有形成分輸注用之線路、替換流體輸注用之線路及治療性藥物用之線路包含適合於當在該等線路中之任一者之傳送構件中存在氣泡時發送能夠停止推進構件之動作之訊號之氣泡偵測器。
在本發明之一個實施例中,TPE裝置包含用於量測該等線路中之壓力之構件。
在本發明之一個實施例中,TPE裝置包含允許在替換流體線路與抗凝血劑流體線之間連通之傳送構件。
在本發明之一個實施例中,替換流體係具有0.8至1% w/v之濃度之NaCl水溶液。
1:管道
2:泵
3:抽出區(抽出/輸注區)
4:入口
5:分離單元
6:管道
7:泵
8:抗凝血劑之袋
9:管道
10:血漿之袋
11:出口
12:管道
13:有形成分之袋
14:管道
15:泵
16:出口
17:輸注區
18:管道
19:泵
20:替換流體之袋
21:結合點
22:管道
23:泵
24:結合點
25~27:管道
28:結合點
29~31:閥
32~34:小瓶
35:結合點
36~38:Y型連接器
39:氣泡偵測器
40~46:管道
47:徑向分配器
在下文關於以下諸圖詳細描述本發明,以下諸圖不限制本發明之範疇。
圖1係本發明之TPE裝置之第一實施例之圖示。
圖2係本發明之TPE裝置之第二實施例之圖示。
圖3係本發明之TPE裝置之第三實施例之前視圖。
在第一實施例中,如在圖1中可見,TPE裝置含有由管道1及泵2組成之供給線路。該供給線路自抽出區3延伸至分離單元5之入口4且將全血自抽出區3輸送至該分離單元之入口4。抗凝血劑線路由管道6、泵7及抗凝血劑之袋8組成,該抗凝血劑線路自袋8延伸至供給線路且將抗凝血劑流體自該袋8輸送至供給線路,抗凝血劑流體在供給線路中與全血混合,之後血液進入分離單元5,在該分離單元中,患者血液分離成血液血漿與有形成分。血漿線路由管道9及袋10組成,該血漿線路自分離單元之出口11延伸至血液血漿之袋10且將該血漿自出口11輸送至袋10,血漿儲存於該袋中。有形成分輸注用之線路由管道12、有形成分之袋13、管道14及泵15組成,該有形成分線路自分離單元之出口16延伸至輸注區17且將分離單元5分離出之有形成分自出口16輸送至袋13,該等有形成分在血漿置換術過程之初始步驟中儲存於該袋中,且接著將儲存於袋13中之有形成分自該袋13輸送至輸注區17。替
換流體輸注用之線路由管道18、泵19、替換流體之袋20、自結合點21延伸至輸注區17之管道以及泵15組成,該替換流體線路自袋20延伸至輸注區17且將替換流體自該袋20輸送至輸注區17。最後,治療性藥物用之線路由管道22、泵23、在結合點24處與管道22匯合之管道25、26及27、調節來自小瓶32、33及34之治療性藥物之通過之閥29、30及31以及自結合點28延伸至輸注區17之管道組成,因而治療性藥物用之線路自小瓶32、33及34延伸至輸注區17。該治療性藥物用之線路將來自該等小瓶32、33及34之治療性藥物輸送至輸注區17。
在第二實施例中,如圖2中可見,TPE裝置含有與輸注區重合之抽出區,該區被稱為抽出/輸注區3。TPE裝置另外含有由管道1及泵2組成之供給線路,該供給線路自抽出/輸注區3延伸至分離單元5之入口4且將全血自抽出/輸注區3輸送至分離單元5。抗凝血劑線路由管道6、泵7及抗凝血劑之袋8組成,該抗凝血劑線路自袋8延伸至結合點36且將抗凝血劑流體自袋8輸送至供給線路,抗凝血劑流體在供給線路中與全血混合,之後該血液進入分離單元,在該分離單元中,血液分離成血液血漿與有形成分。血漿線路由管道9及血漿之袋10組成,該血漿線路自分離單元之出口11延伸至袋10且將分離單元分離出之血液血漿自出口11輸送至袋10,血液血漿儲存於該袋中。有形成分輸注用之線路由管道12、有形成分之袋13、管道14、
自結合點35延伸至抽出/輸注區3之管道以及泵2組成,因而該有形成分線路自分離單元之出口16延伸至抽出/輸注區3且將分離單元分離出之有形成分自出口16輸送至抽出/輸注區3。替換流體輸注用之線路由管道18、泵19、替換流體之袋20、自結合點21延伸至抽出/輸注區3之管道以及泵2組成,因而該替換流體線路自袋20延伸至抽出/輸注區3且將替換流體自該袋20輸送至抽出/輸注區3。最後,治療性藥物用之線路由管道22、泵23、在結合點24處與管道22匯合之管道25、26及27、調節來自小瓶32、33及34之治療性藥物之通過之閥29、30及31、自結合點28延伸至抽出/輸注區3之管道以及泵2組成,因而治療性藥物線路自小瓶32、33及34延伸至抽出/輸注區3,將來自該等小瓶之治療性藥物輸送至抽出/輸注區3。
在第三實施例中,如圖3中可見,TPE裝置含有與輸注區重合之抽出區且可被稱為抽出/輸注區3或靜脈接入構件。該實施例之裝置亦含有血液供給線路,其由靜脈接入構件、Y型連接器36、管道41、Y型連接器37、管道42、泵2、徑向分配器47以及管道43組成,因而該供給線路自抽出/輸注區3延伸至分離單元5之入口4且將全血自抽出/輸注區3輸送至分離單元5。抗凝血劑線路由抗凝血劑之袋8、管道45、Y型連接器38、管道46、泵7以及Y型連接器36組成,因而該線路自袋8延伸至Y型連接器36,將抗凝血劑流體自該袋8輸送至供給線路,抗凝血
劑流體在供給線路中與全血混合,之後該血液進入分離單元5,在該分離單元中,血液分離成血液血漿與有形成分。血漿線路由管道9及血漿之袋10組成,該血漿線路自分離單元之出口11延伸至袋10且將血液血漿自出口11輸送至袋10,血液血漿儲存於該袋中。有形成分輸注線路由管道12、有形成分之袋13、管道14、徑向分配器47、泵2、管道42、氣泡偵測器39、Y型連接器37、管道41、Y型連接器36以及靜脈接入構件組成,因而該有形成分線路自分離單元之出口16延伸至抽出/輸注區3且將分離出之有形成分自出口16輸送至抽出/輸注區3。替換流體輸注用之線路由替換流體之袋20、管道18、徑向分配器47、管道42、泵2、氣泡偵測器39、Y型連接器37、管道41、Y型連接器36以及靜脈接入構件組成,因而該替換流體線路自袋20延伸至抽出/輸注區3,將替換流體自該袋20輸送至抽出/輸注區3。治療性藥物用之線路由治療性藥物之小瓶32、管道22、徑向分配器47、管道42、泵2、氣泡偵測器39、Y型連接器37、管道41、Y型連接器36以及靜脈接入構件組成,因而該治療性藥物用之線路自小瓶32延伸至抽出/輸注區3,將治療性藥物自小瓶32輸送至抽出/輸注區3。此外,圖3之TPE裝置亦含有用於量測線路之壓力之構件,該等構件由管道40、41以及未在圖中示出之用於量測壓力之單元組成。最後,圖3之裝置含有允許抗凝血劑線路連接至替換流體線路之管道44。如上所述,徑向分配器47形成先前技術之部分,該分配器包含複數個閥,其
允許複數個管道(例如管道14、18、22、42或43)連通,使得藉由控制該等閥,有可能允許特定液體通過且阻止其他液體經由該分配器通過。
1‧‧‧管道
2‧‧‧泵
3‧‧‧抽出區
4‧‧‧入口
5‧‧‧分離單元
6‧‧‧管道
7‧‧‧泵
8‧‧‧抗凝血劑之袋
9‧‧‧管道
10‧‧‧血漿之袋
11‧‧‧出口
12‧‧‧管道
13‧‧‧有形成分之袋
14‧‧‧管道
15‧‧‧泵
16‧‧‧出口
17‧‧‧輸注區
18‧‧‧管道
19‧‧‧泵
20‧‧‧替換流體之袋
21‧‧‧結合點
22‧‧‧管道
23‧‧‧泵
24‧‧‧結合點
25~27‧‧‧管道
28‧‧‧結合點
29~31‧‧‧閥
32~34‧‧‧小瓶
Claims (10)
- 一種治療性血漿置換術用之裝置,其包含:體外迴路;以及治療性藥物用之至少一個獨立的線路,前述體外迴路包含血液供給線路、分離單元、有形成分輸注用之線路、替換流體之輸注用之線路、血液血漿線路及抗凝血劑線路,前述治療性藥物用之至少一個獨立的線路包含儲存構件、傳送構件、推進構件及用於前述治療性藥物之流量控制構件,其特徵在於前述治療性藥物用之至少一個獨立的線路與前述裝置之其他線路中之一或多者共用前述傳送構件、前述推進構件及前述流量控制構件,經共用的前述推進構件係至少一個蠕動泵,且經共用的前述流量控制構件併入於徑向分配器中。
- 如請求項1所記載之治療性血漿置換術用之裝置,其中前述蠕動泵係可逆蠕動泵。
- 如請求項1所記載之治療性血漿置換術用之裝置,其中前述裝置具有重合之血液抽出區與患者輸注區。
- 如請求項1所記載之治療性血漿置換術用之裝置,其中前述治療性藥物包含選自由以下組成之群組之人類血漿蛋白:5-25%之白蛋白、α1抗胰蛋白酶、馮威裡氏因子、包含凝血因子VII、凝血因子VIII及凝血因子 IX之凝血因子、免疫球蛋白、纖溶酶原、纖溶酶、抗凝血劑酶III、纖維蛋白原、纖維蛋白、凝血酶及其組合。
- 如請求項1所記載之治療性血漿置換術用之裝置,其中前述分離單元係過濾器。
- 如請求項5所記載之治療性血漿置換術用之裝置,其中前述過濾器係中空纖維過濾器。
- 如請求項1所記載之治療性血漿置換術用之裝置,其中前述有形成分輸注用之線路、前述替換流體之輸注用之線路或前述治療性藥物用之至少一個獨立的線路包含氣泡偵測器。
- 如請求項1所記載之治療性血漿置換術用之裝置,其中前述裝置進一步包含用於量測前述裝置之前述線路中之壓力之構件。
- 如請求項1所記載之治療性血漿置換術用之裝置,其中前述裝置進一步包含允許前述替換流體之輸注用之線路與前述抗凝血劑線路連通之傳送構件。
- 如請求項1所記載之治療性血漿置換術用之裝置,其中前述替換流體係具有0.8至1.0% w/v之濃度之NaCl水溶液。
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AU2018201969A1 (en) | 2018-10-18 |
RU2018109409A3 (zh) | 2021-05-13 |
TW201838676A (zh) | 2018-11-01 |
BR102018005135A2 (pt) | 2018-10-30 |
AU2018201969B2 (en) | 2023-06-29 |
EP3381485A1 (en) | 2018-10-03 |
ES2629163B1 (es) | 2017-12-01 |
KR102566825B1 (ko) | 2023-08-11 |
IL258015A (en) | 2018-04-30 |
MX2018003241A (es) | 2019-02-07 |
AR111529A1 (es) | 2019-07-24 |
SG10201801962VA (en) | 2018-10-30 |
US20180280603A1 (en) | 2018-10-04 |
CA2998586A1 (en) | 2018-09-30 |
ES2629163A1 (es) | 2017-08-07 |
CN108686277A (zh) | 2018-10-23 |
RU2755866C2 (ru) | 2021-09-22 |
CL2018000623A1 (es) | 2018-05-25 |
ES2938189T3 (es) | 2023-04-05 |
RU2018109409A (ru) | 2019-09-16 |
JP2018171434A (ja) | 2018-11-08 |
KR20180111532A (ko) | 2018-10-11 |
JP6717870B2 (ja) | 2020-07-08 |
UY37633A (es) | 2018-07-31 |
IL258015B (en) | 2022-04-01 |
EP3381485B1 (en) | 2022-11-30 |
HK1259076A1 (zh) | 2019-11-22 |
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