477696 A7 _______B7___ 五、發明說明（I ) 本發明係有關一種收集及儲存血液之袋囊系統及收集 及儲存血液之方法。 (請先閱讀背面之注意事項再填寫本頁) 自人體抽取血液及儲存此血液於一冷凍或冷藏狀態以 供後來手術中、輸血及類似件之使用已廣爲人知。爲此目 的，已有多種不同的血液袋囊被提供。 於過去幾年，於出生時出自臍帶及胎盤之血液含帶幹 細胞已爲人知，此種細胞僅於人一生中之此特定時刻存在 血液中。此些細胞顯示相當可觀之潛在治療價値，例如用 於癌症治療中及其他免疫缺陷性疾病之骨髓移植程序。 爲保存此些細胞，取自臍帶及/或胎盤之血液，不再 被丟棄，而被收集起來並以低溫儲存。使用於此種序中之 容器爲已知如上述之習知血液袋囊。 然而，爲自冷凍血液之袋囊中取樣，必須將整袋血液 解凍，而一旦解凍，由於其不能再冷凍，便必須隨後迅速 使用或丟棄。因此有關習知袋囊及方法之問題便是使用幹 細胞以治療病人之機會僅限爲一次。 日本專利IP 10000224 A揭示了一種藉離心方法自臍帶 血液隔離幹細胞及先前細胞的袋囊系統。此系統由6個袋 囊構成，其等設有接頭及自袋囊引導血液至袋囊之導管’ .包括一個袋囊，於其內所得之含有上述細胞之白血球成分 被冷凍。此袋囊有關之問題係’無論如何’同樣地’其不 可能解凍部分細胞而不破壞其餘的細胞。 因此，本發明之目的爲提供上述問題之解決之道。尤 其是提供一種用於收集及儲存血液特別是腰帶血液及/或 3 本紙張尺度適用中國國家標準（CNS)A4規格（210 x 297公釐） 477696 A7 __B7______ 五、發明說明（Y) 來自胎盤之血液的袋囊系統，其設計成使僅解凍部分之儲 存血液成爲可能。 本發明係有關一種如申請專利範圍第1項所界定之用 於收集及儲存血液之袋囊系統，一種如申請專利範圍第4 項所界定之用於收集及儲存血液之袋囊系統結合一混合袋 囊，及一種如申請專利範圍第5項所界定之用於收集、混 合及儲存血液之袋囊系統。 依據本發明之袋囊系統可包含一只有儲存室之系統， 僅設有一接收血液之開口，或用於接收血液之開口可包括 一進口通道。此進口通道可爲一小導管’其連接至一套有 例如一彈簧鎖，一夾子或便於操作以閉合裝置之相似件的 混合室。 本發明之另一觀點係一種結合一混合袋囊用於收集及 儲存血液之袋囊系統，該混合袋囊包括至少一混合室、一 用於接收血液之開口及一用於排放血液之開口。就混合袋 囊而言，用於接收血液之開口及用於排放血液的開口可爲 相同。用於排放血液之開口係適以連接至用於收集及儲存 血液之袋囊系統中之接收血液用之開口，例如藉由使用適 當之接頭。 本發明之進一步觀點係一種包括一混合室之用於收集 及儲存血液之袋囊系統，藉由閉合例如一彈簧鎖或使用一 夾子或以熔接方式’混合室可自儲存室被密封開。爲使被 儲存之供應墓最小’其較佳爲該混合室被安排成連接至儲 存室之方式係使其可於儲存前自儲存室密封開並移除。 4 ------------裝--------訂--------- ί靖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><297公釐)" 477696 A7 ___B7___ 五、發明說明（\)) 一種依據本發明之袋囊系統之混合室應具有一容積， 其符合或大於初級及次級儲存室之總合容積。爲使用混合 室以混合血液及抗凝血劑及/或保存劑，混合袋囊之容積 較佳爲至少係初級及次級儲存室容積和之兩倍。混合室之 容積範圍可爲例如100至500ml，較佳爲225至400ml，更 佳爲250至300ml。於一較佳實施例中，混合室之容積範 圍可例如爲100至500ml，較佳爲125至400ml，更佳爲 150 至 250πύ。 混合室可進一步包括至少一通口，用於注入抗凝血劑 及/或保存劑，及/或包括至少一通口，用於抽出血液以 進行測試，例如以檢測病毒引起之污染。 於所有上述之袋囊中，初級及次級儲存室皆彼此爲液 體相連通方式。此種液體相連通方式，較佳可設置以長度 範圍爲10至20 mm，較佳爲12至15 mm之連接管。於另一 種實施例中，連接管之長度範圍爲10至300 mm，較佳爲約 100 mm 〇 該等連接管之內徑可於2至10 mm之範圍內，較佳爲3 至8 nun範圍內，當連接管於非洩放皺縮之狀態下，更佳爲 4至6 mm範圍內。 於密封各儲存室之過程中，例如藉由熔接（熱熔接、 脉衝焊或其他）或藉由閉合一彈簧鎖或一夾子之密封過程 ，較佳係緊接於塡充完成之後，確保僅極小量所得之血液 被破壞是很重要的。依據本發明之袋囊系統，設置有僅含 有一極少量血液之上述連接管，以確保藉由例如加熱以閉 5 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) ▼裝 訂---------- 477696 A7 ____B7__ 五、發明說明（f ) 合此些儲存室有關所破壞之血液’僅係佔總血量相當少之 百分比。+ 藉由使用依據本發明之一袋囊系統，用以儲存臍帶血 液，其係有可能得到至少二個’較佳爲至少五個初級儲存 室，更佳爲至少八個初級儲存室，且最佳爲至少十個初級 儲存室，全部含帶有血液。當然塡注有血液之儲存室的數 目是依據自臍帶及胎盤所可能抽出之血液的多少及血液袋 囊之設計而決定的。 初級儲存室之容積範圍通常係於10至40ml之範圍’ 較佳爲25至35ml，更佳爲25至30ml。於另一實施例中， 初級儲室之容積範圍爲10至80mi，較佳爲25至70ml，更 佳爲25至50ml。 然而愈多儲存室愈好，因爲此可提供病患在使用儲存 血液上最大的彈性。由於任何數目之充塡有血液之儲存室 可自袋囊被移開，其便有可能只解凍打算處理所需之血液 量° 儲存室系統亦包括一些次級儲存室，較佳爲相當至少 初級儲存室之數目，所有之次級儲存室皆如初級儲存室可 被獨立地密封或移開。此些次級儲存室之目的係提供少量 .用爲測試目的之血液。因此，初級和次級儲存室之容積比 較佳爲介於40 : 1及60 : 1之間，更佳爲約50 : 1。於另一 實施例中，初級和次級儲室間之容積比係介於40 ·· 1及 150 : 1之間，較佳爲介於50 : 1至80 : 1之間。 具有次級儲存室，其容積範圍爲0.2至1.5ml之間，較 6 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） -----------裝--------訂---------丨 (請先閱讀背面之注意事項再填寫本頁) 477696 A7 B7 五、發明說明（t： 佳爲0.3至0.7ml之間，更佳爲0.4至0.6ml之間，除開解 凍所需量，需要多於一或二個次級儲存室以得到例如0.5ml 之所需血液量，以測試其或查看其是否適用。此種特別之 特徵係相當重要的，因爲其基本上決定了血液之品質，以 找出處理所需血液之正確量，以檢測血液之污染（例如細 菌），或進行一基因測試。 於一較佳實施例中，所有初級儲存室皆有標註，或可 適以個別標註，各有至少一個相對應之次級儲存室。再者 ’袋囊系統本身最好有標註，或可適以標註有日期及/或 一號碼，以便能辨識該袋囊。 初級儲存室可有各種形狀，然而較佳之實施例爲當袋 囊系統於浅放皺縮之狀態下大致係方形或大致係圓形者。 由於長時間儲存血液典型地包括將袋囊系統置於_17〇 °〇之溫度下，袋囊系統以合適之材料製成係相當重要的， 例如以醫療或藥學之等級的材料。適用之材料之範例如聚 乙烯、乙烯-乙酸乙烯酯共聚物、氟樹脂、聚亞胺矽酮、 ABS聚合物（丙嫌腈/丁二烯/苯乙烯聚合物）或聚碳酸 衣囊系統可包括一或多摺層，例如藉由焊接連結，而 於多於-麵之龍下，衫_可選自上述之材料中， 且可爲彼此相同或相異。 * 、、於-依據本發明之較佳實麵中，袋囊系統包括以上 述之材料所製成之痛存室，_囊系統被配置 或可被配讎第二賴巾，例__簡料製成之第二 -----------裝--------訂--------- (請先閱讀背面之注意事項再填寫本頁) 477696 A7 ___B7__；_ 五、發明說明（I ) 袋囊包覆袋囊系統。第二袋囊可被分成數個隔室。 本發明亦有關用於收集及儲存臍帶血液及7或來自脃 盤之血液的方法，其包括下列步驟： a) 自臍帶及/或胎盤抽出血液， b) 將血液引導至一混合室，例如以注入之方式， c) 將血液和保存劑及/或抗凝血劑混合， d) 選擇性地儲存血液不超過24小時， e) 選擇性地加入其他化合物以準備血液進行冷凍儲存 f) 於混合室和數個儲存室之間提供一液體相連通機制 ，.以使血液混合物流入該等儲存室， g) 以夾子關閉袋囊系統，並選擇性地移開混合室， h) 關閉不同室之間的通道，例如藉由熔接或藉由關閉 一彈簧鎖或一夾子，因而提供了數個彼此互相密封開之初 級及次級儲存室，及 i) 迅速將該袋囊系統置於一冷凍室，將溫度設在低於 約-7(TC， 其中，該初級及該次級儲存室被設置成一袋囊系統’ 其中通道彼此相連且有中間密封，而初級儲存室之容積係 .大於次級儲存室之容積。 可查覺出步驟e)至i)可在儲存血液未超過24小時’於 未有細菌滋長的情況下進行，例如在冷藏室中。 自臍帶抽出血液及引導其進入一混合室可以任何習知 的方式進行。較佳地，抽血須以習於該項技術者所接受的 8 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） -----------裝--------訂--------- (請先閱讀背面之注意事項再填寫本頁) 477696 A7 ____B7__ 五、發明說明（9 ) 方式進行。 抗凝血劑芨7或葆荐I可_霞_ ^ ，然而，其較佳爲在引導血液時，抗凝血劑等已經存在於 該混合室中，而由於混合室可事先準備待用，其便簡化了 方法。 然而，於特殊情況下抽出之血液量少，其較佳可在收 集血液後加入抗凝血劑及/或保存劑，以確保血液及上述 藥劑間之比例係於最佳之可能範圍內。因此，於一較佳之 實施例中，混合室提供有至少一額外通口，以便於添加抗 凝血劑及/或保存劑。 .在將血液和上述用劑混合後，混合室轉成和依據本發 明之袋囊系統之儲存室相流通。依照被使用袋囊之種類， 連接可以管或接頭之方式製成，或者於一本發明之較佳實 施例中，可簡易地藉由打開一介於混合室及儲存室間之彈 簧鎖製成。 此可使血液流入初級及次級儲存室，且在將血液充塡 於儘可能最多之儲存室後，用於收納血液之開口被閉合， 例如以一夾子或彈簧鎖閉合。 由於不需儲存附接著的空混合室，較佳地，係將混合 ,室移開，例如將其切開，或將使用之管或接頭移除。 爲得到可被分別獨立地移除的數個混合室，混合室間 之流通部分被密封起來。此較佳地係可採用加熱方式達成 〇 最後，袋囊系統被冷凍至低於約-70°C之溫度，以確保 9 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） -----------裝--------訂--------- (請先閱讀背面之注意事項再填寫本頁) 477696 A7 __B7_ 五、發明說明（t ) 血液可被保存至需要使用的時候。 圖式簡單說明 本發明之各種實施例將參考所附圖式做一說明。 圖1顯示一種依據本發明之袋囊系統之一較佳實施例 ，其包括一混合室。 圖2顯示依據本發明之一種袋囊系統其可用於連接一 混合袋囊。 圖3顯示依據本發明之一種結合一混合袋囊之袋囊系 統。 圖4顯示依據本發明之一種袋囊系統，其包括一混合 室。 圖5顯示依據本發明之一種袋囊系統之一部分的儲存 室之另一實施例。 圖號簡單說明 (請先閱讀背面之注意事項再填寫本頁) ▼裝 ^ ·11111 1 混合室 2 彈簧鎖 3 管 4 接頭 5 雙重熔接 6 彈簧鎖 7 夾子 8 初級儲存室 9 次級儲存室 10 連接管 10 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） 477696 A7 _ B7 五、發明說明（9 ) 11 入口 12 岀□ 13 儲存袋囊 21 開口 22 彈簧鎖 23 夾子 24 初級儲存室 25 次級儲存室 26 連接管 31 混合袋囊 32 混合室 33 雙重熔接 34 接頭 35 儲存袋囊 36 開口 37 彈簧鎖 38 夾子 39 初級儲存室 40 次級儲存室 41 連接管 42 開口 43 通口 45 接頭 46 連接管 11 -----------裝—----訂--------- (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 X 297公釐） 477696 A7477696 A7 _______B7___ 5. Description of the Invention (I) The present invention relates to a pouch system for collecting and storing blood and a method for collecting and storing blood. (Please read the precautions on the back before filling out this page.) It is widely known that blood is drawn from the human body and stored in a frozen or refrigerated state for later use during surgery, blood transfusions, and the like. For this purpose, a number of different blood pouches have been provided. In the past few years, blood-containing stem cells derived from the umbilical cord and placenta at birth have been known. Such cells exist in the blood only at this specific time in a person's life. These cells show considerable potential therapeutic value, such as bone marrow transplantation procedures used in cancer treatment and other immunodeficiency diseases. To preserve these cells, blood from the umbilical cord and / or placenta is no longer discarded, but collected and stored at low temperature. The container used in this procedure is a conventional blood pouch known as described above. However, in order to take samples from frozen blood sacs, the whole bag of blood must be thawed, and once it is thawed, it must be quickly used or discarded afterwards because it can no longer be frozen. Therefore, the problem with the conventional bag and method is that the chance of using stem cells to treat patients is limited to one time. Japanese patent IP 10000224 A discloses a pouch system that isolates stem cells and previous cells from umbilical cord blood by centrifugation. This system is composed of 6 sacs, which are provided with a connector and a catheter for guiding blood from the sac to the sac. The sac includes a sac, and the white blood cell component containing the cells is frozen. The problem with this pouch is that 'anyhow' the same 'it is not possible to thaw some cells without destroying the remaining cells. It is therefore an object of the present invention to provide a solution to the above problems. In particular, it provides a method for collecting and storing blood, especially belt blood, and / or 3 paper sizes applicable to Chinese National Standard (CNS) A4 (210 x 297 mm) 477696 A7 __B7______ 5. Description of the invention (Y) The blood pouch system is designed to make it possible to store only the thawed part of the blood. The present invention relates to a pouch system for collecting and storing blood as defined in the scope of patent application item 1 and a pouch system for collecting and storing blood as defined in the scope of patent application item 4 combined with a hybrid A pouch, and a pouch system for collecting, mixing, and storing blood as defined in item 5 of the patent application. The pouch system according to the present invention may include a storage-only system provided with only one opening for receiving blood, or the opening for receiving blood may include an inlet channel. This inlet channel may be a small conduit ' which is connected to a set of mixing chambers with, for example, a snap lock, a clip, or the like which is convenient to operate to close the device. Another aspect of the present invention is a pouch system for collecting and storing blood in combination with a hybrid pouch including at least a mixing chamber, an opening for receiving blood, and an opening for draining blood. In the case of a mixed pouch, the openings for receiving blood and the openings for discharging blood may be the same. The opening for draining blood is adapted to be connected to an opening for receiving blood in a pouch system for collecting and storing blood, for example by using a suitable connector. A further aspect of the present invention is a pouch system for collecting and storing blood including a mixing chamber, which can be sealed from the storage chamber by closing, for example, a snap lock or using a clip or by welding. To minimize the stored supply tomb, it is preferred that the mixing chamber is arranged to be connected to the storage chamber in such a way that it can be sealed and removed from the storage chamber before storage. 4 ------------ install -------- order --------- ί Jing first read the precautions on the back before filling out this page) This paper size applies to China National Standard (CNS) A4 Specification (210 > < 297 mm) " 477696 A7 ___B7___ V. Description of the Invention (\)) A mixing chamber of a bag system according to the present invention should have a volume that meets or exceeds the primary And the total volume of the secondary storage room. To use a mixing chamber to mix blood and anticoagulant and / or preservative, the volume of the mixing pouch is preferably at least twice the volume of the primary and secondary storage chambers. The volume of the mixing chamber may be, for example, 100 to 500 ml, preferably 225 to 400 ml, and more preferably 250 to 300 ml. In a preferred embodiment, the volume range of the mixing chamber may be, for example, 100 to 500 ml, preferably 125 to 400 ml, and more preferably 150 to 250πύ. The mixing chamber may further include at least one port for injecting anticoagulant and / or preservative, and / or at least one port for withdrawing blood for testing, such as to detect virus-induced contamination. In all the aforementioned bags, the primary and secondary storage chambers are in fluid communication with each other. This liquid communication method can preferably be provided with a connecting pipe having a length ranging from 10 to 20 mm, preferably 12 to 15 mm. In another embodiment, the length of the connecting pipe is 10 to 300 mm, preferably about 100 mm. The inner diameter of the connecting pipes may be in the range of 2 to 10 mm, preferably 3 to 8 nun. Inside, when the connecting tube is in a non-bleeding and shrinking state, it is more preferably within the range of 4 to 6 mm. In the process of sealing each storage chamber, for example, by welding (thermal welding, pulse welding or other) or by closing a snap lock or a clip, it is preferable to ensure that only after the filling is completed, only It is important that very small amounts of blood are destroyed. According to the bag system of the present invention, the above-mentioned connection tube containing only a very small amount of blood is provided to ensure that, for example, heating is used to close 5 paper sizes to apply Chinese National Standard (CNS) A4 specifications < 210 X 297 mm) (Please read the precautions on the back before filling this page) ▼ Binding ---------- 477696 A7 ____B7__ V. Description of the Invention (f) The damage to the blood in these storage rooms is only the total Quite a small percentage of blood. + By using a pouch system according to the present invention for storing umbilical cord blood, it is possible to obtain at least two 'preferably at least five primary storage chambers, more preferably at least eight primary storage chambers, and most Preferably there are at least ten primary storage compartments, all containing blood. Of course, the number of blood-filled storage rooms is determined by the amount of blood that can be drawn from the umbilical cord and placenta and the design of the blood bag. The volume of the primary storage compartment is usually in the range of 10 to 40 ml ', preferably 25 to 35 ml, and more preferably 25 to 30 ml. In another embodiment, the volume of the primary storage compartment is in the range of 10 to 80 mi, preferably 25 to 70 ml, and more preferably 25 to 50 ml. However, more storage rooms are better because this provides the patient with the greatest flexibility in using stored blood. Since any number of blood-filled storage chambers can be removed from the pouch, it is possible to thaw only the amount of blood that is intended to be processed. The storage chamber system also includes some secondary storage chambers, preferably at least primary The number of storage compartments, all secondary storage compartments, like the primary storage compartment, can be independently sealed or removed. The purpose of these secondary storage rooms is to provide small amounts of blood for testing purposes. Therefore, the volume ratio of the primary and secondary storage chambers is preferably between 40: 1 and 60: 1, and more preferably about 50: 1. In another embodiment, the volume ratio between the primary and secondary storage compartments is between 40 ·· 1 and 150: 1, preferably between 50: 1 and 80: 1. It has a secondary storage room with a volume ranging from 0.2 to 1.5ml. Compared with 6 paper sizes, it conforms to the Chinese National Standard (CNS) A4 specification (210 X 297 mm). -------- Order --------- 丨 (Please read the notes on the back before filling this page) 477696 A7 B7 V. Description of the invention (t: preferably between 0.3 and 0.7ml , More preferably between 0.4 and 0.6ml, in addition to the amount required for thawing, more than one or two secondary storage compartments are needed to obtain, for example, the required blood volume of 0.5ml to test it or see if it applies. The special characteristics are very important, because they basically determine the quality of the blood, to find the correct amount of blood for processing, to detect blood contamination (such as bacteria), or to perform a genetic test. In the example, all primary storage rooms are labeled, or they can be labeled individually, and each has at least one corresponding secondary storage room. Furthermore, the bag system itself is preferably labeled, or it can be labeled with a date and And / or a number so that the pouch can be identified. The primary storage chamber can have various shapes, but the preferred embodiment is When the pouch system is generally square or round in a shallowly collapsed state. Since long-term storage of blood typically includes placing the pouch system at a temperature of -17 ° C, the pouch system is suitable for The material made is very important, such as medical or pharmaceutical grade materials. Examples of suitable materials are polyethylene, ethylene-vinyl acetate copolymer, fluororesin, polyimide silicone, ABS polymer (c (Nitrile / butadiene / styrene polymer) or polycarbonate capping system can include one or more layers, such as by welding, and under more than-face of the dragon, the shirt can be selected from the above materials In the preferred embodiment of the present invention, the pouch system includes a pain storage chamber made of the above materials, and the pouch system is configured or can be With the second Lai towel, for example __ the second made of simple materials ----------- installed -------- order --------- (please first Read the notes on the back and fill out this page) 477696 A7 ___B7__; _ V. Description of the invention (I) The bag covers the bag system. The second bag can be divided into several compartments. The present invention also relates to a method for collecting and storing umbilical cord blood and 7 or blood from the pancreas, comprising the following steps: a) drawing blood from the umbilical cord and / or placenta, b) directing the blood to a mixing chamber, such as Method of injection, c) mixing blood with preservative and / or anticoagulant, d) selectively storing blood for no more than 24 hours, e) selectively adding other compounds to prepare blood for frozen storage f) mixing A liquid communication mechanism is provided between the chamber and several storage chambers to allow the blood mixture to flow into the storage chambers, g) the pouch system is closed with a clip, and the mixing chamber is selectively removed, h) the different chambers are closed Passages, such as by welding or by closing a snap lock or a clip, thus providing several primary and secondary storage compartments sealed from each other, and i) quickly placing the pouch system in a freezer compartment , Set the temperature below about -7 (TC, where the primary and secondary storage chambers are set up as a pouch system 'where the channels are connected to each other with an intermediate seal, and the volume of the primary storage chamber is greater than the secondary Store The volume of the room. It can be detected that steps e) to i) can be performed without storing the blood for more than 24 hours' without the growth of bacteria, such as in a refrigerator. Withdrawing blood from the umbilical cord and directing it into a mixing chamber can be performed in any conventional manner. Preferably, the blood drawing should be in accordance with the Chinese National Standard (CNS) A4 specification (210 X 297 mm) in 8 paper sizes accepted by those skilled in the art. ------- Order --------- (Please read the notes on the back before filling out this page) 477696 A7 ____B7__ V. Description of Invention (9). The anticoagulant 芨 7 or I recommend I 可 _ 霞 _ ^, however, it is preferable that anticoagulant and the like already exist in the mixing chamber when guiding blood, and since the mixing chamber can be prepared for use in advance, This simplifies the method. However, under special circumstances, the amount of blood drawn is small. It is preferable to add anticoagulants and / or preservatives after collecting blood to ensure that the ratio between blood and the above-mentioned agents is within the best possible range. Therefore, in a preferred embodiment, the mixing chamber is provided with at least one additional port to facilitate the addition of anticoagulants and / or preservatives. After the blood and the above-mentioned agents are mixed, the mixing chamber is transferred to the storage chamber of the pouch system according to the present invention. Depending on the type of pouch being used, the connection can be made in the form of a tube or joint, or in a preferred embodiment of the invention, it can simply be made by opening a spring lock between the mixing chamber and the storage chamber. This allows blood to flow into the primary and secondary storage chambers, and after filling the blood with as many storage chambers as possible, the opening for receiving blood is closed, for example with a clip or a snap lock. Since there is no need to store the attached empty mixing chamber, it is preferable to remove the mixing chamber, for example, to cut it open, or to remove the used tube or joint. In order to obtain several mixing chambers which can be removed independently, the flow-through portions between the mixing chambers are sealed. This is best achieved by heating. Finally, the pouch system is frozen to a temperature below about -70 ° C to ensure that 9 paper sizes are compatible with Chinese National Standard (CNS) A4 (210 X 297 mm). ) ----------- Installation -------- Order --------- (Please read the notes on the back before filling this page) 477696 A7 __B7_ V. Invention Note (t) Blood can be stored until needed. BRIEF DESCRIPTION OF THE DRAWINGS Various embodiments of the present invention will be described with reference to the drawings. FIG. 1 shows a preferred embodiment of a pouch system according to the present invention, which includes a mixing chamber. Figure 2 shows a bag system according to the present invention which can be used to connect a hybrid bag. Figure 3 shows a pouch system incorporating a hybrid pouch according to the present invention. Fig. 4 shows a pouch system according to the present invention, which includes a mixing chamber. Fig. 5 shows another embodiment of a storage chamber as part of a pouch system according to the present invention. Brief description of the drawing number (please read the precautions on the back before filling this page) ▼ Installation ^ · 11111 1 Mixing chamber 2 Spring lock 3 Pipe 4 Connector 5 Double welding 6 Spring lock 7 Clip 8 Primary storage room 9 Secondary storage room 10 Connection tube 10 This paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) 477696 A7 _ B7 V. Description of the invention (9) 11 Inlet 12 岀 □ 13 Storage bag 21 Opening 22 Spring lock 23 Clip 24 Primary storage chamber 25 Secondary storage chamber 26 Connecting tube 31 Mixing pouch 32 Mixing chamber 33 Double welding 34 Connector 35 Storage pouch 36 Opening 37 Spring lock 38 Clip 39 Primary storage chamber 40 Secondary storage chamber 41 Connecting tube 42 Opening 43 Mouth 45 Connector 46 Connection tube 11 ----------- Installation ----- Order --------- (Please read the precautions on the back before filling this page) This paper size Applicable to China National Standard (CNS) A4 (210 X 297 mm) 477696 A7
五、發明說明（p) 48 初級儲存室 49 接頭 5〇 次級儲存室 51 機構 βΐ 初級儲存室 63 接頭 64 夾子 65 次級儲存室 圖1顯示依據本發明之一種袋囊系統，其包括一具有 一雙重熔接(5)之混合室（1)，以及一具備有一管⑶之入口 (11)，管(3)之一端設置有一接頭(4) ’以和用於收集血液之 針管連接。二彈簧鎖⑵和⑹設置於混合室⑴之入口（11)及 出口（12)處。儲存袋囊（13)經由具備有—夾子⑺之管（14)而 和混合室（1)相連接，儲存袋囊（13)包括十個初級儲存室(8) 及十個次級儲存室(9)，彼此以連接管（1〇)至相流通。虛線 顯示袋囊系統熔接處，熔接係用於在袋囊系統塡滿血液後 密封各儲存室。 當使用一依據圖1之袋囊系統時，血液被導入混合室 (1)，於該處前述必要之用劑較佳地係已經存在了，然而彈 ^簧鎖(2)被閉合，袋囊系統被上下倒置或被搖晃以恰當地混 合各成分。然後打開彈簧鎖(6)，血液混合物流入儲存袋囊 (13) ’塡充至最大數目之初級⑻及次級⑼儲存室。爲確保 血液混合物可恰當地流入儲存室，處理袋囊系統者較佳地 係可稍微擠壓或搖晃袋囊，以使血液混合物較易流動。 12 本紙張尺度適用中國國家標準（CNS)A4規格（21〇 X 297公楚） -------------------^--------- (請先閱讀背面之注意事項再填寫本頁) 477696 A7 __B7 _ 五、發明說明（（I) 當所有包容於混合室（1)之血液混合物已流入儲存袋囊 (13)，夾子(7)已閉合，且混合室⑴被切除。然後，在緊接 袋囊系統已被塡滿或至少在即將冷凍袋囊之前連接管（10) 例如以熔接方式閉合。若有合適的熔接設備，或是袋囊系 統可置於一大致24小時內無細菌繁殖之溫度時，且於該段 時間被運送至執行熔接之設備，則熔接可於該處執行。 圖1顯示依據本發明之一袋囊系統之較佳實施例，其 中混合室構成該袋囊系統之部分。於依據本發明之如此之 袋囊系統中，混合室係包含爲袋囊系統之一部分，由於不 需和周圍環境接觸，例如一當血液被輸入袋囊系統後，將 血液自一袋囊傳送至另一袋囊，因此感染之危險性被減至 最小。此種袋囊系統亦確保在收集了儲存血液之過程中， 僅最少量之血液損失或破壞掉。在取自臍帶及胎盤之血液 量極少之情況中，此一特徵是極爲重要的。 如圖1所示，初級儲存室及連接管構成一特定的形式 。然而，此僅只一種範例形式，其當尙有多種適當之形式 ，例如圖2及圖3中所顯示之形式。而重要之觀念在於該 形式係設計成使其可儘量地塡滿最多之儲存室’即使僅有 少量之血液可被取得。 圖2顯示一種依據本發明之儲存袋囊，其具有一用於 接收血液而配置一彈簧鎖(22)及一夾子(23)之開口（21)。該 袋囊包括十二個初級儲存室(24)及十二個次級儲室(25) ’彼 此經由連接管(26)相互流通。虛線顯示袋囊在塡注血液後 ，被熔接以密封各儲存室之處。 13 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） -----------裝--------訂--------- (請先閱讀背面之注意事項再填寫本頁) 477696 A7 ______Β7__ _ 五、發明說明（卜) 此袋囊可用於和混合袋囊相連接，其中被抽取之血液 和前述之劑液相混合。一一—一---------------------------------------------------------------------------------------------- 圖3顯示依據本發明之一種混合袋囊(31)及一種儲存 袋囊(35)。該混合袋囊(31)包括一混合室(32)，其由雙重熔 接（33)所環繞，且具有用以和儲存袋囊（35)相連接之接頭 (34)。儲存袋囊（35)具有一用於接收血液而配置一彈簧鎖 (37)及一夾子(38)之開口（36)。該袋囊(35)包括十個初級儲存 室(39)及十個次級儲存室(40)，彼此經由連接管(41)相互流 通。虛線顯示袋囊在塡注血液後，被熔接以密封各儲存室 之處。 圖4顯示依據本發明之一種袋囊系統，其包括一混合 室(41)，混合室(41)具有用於將混合室吊掛於一適當之支架 或相似裝置之機構(51)、一用於接收及排放血液之開口， 及包括一用於注入添加物及/或抽出測試用血液之另一通 口（43)。該袋囊系統進一步包括四個初級儲存室(48)，彼此 相流通，並經由連接管(46)及接頭(45、49)和混合室相流通 ，而各初級儲存室相連接有二個次級儲存室(50)。各初級 儲存室可以夾子(47)彼此密封開，或自混合袋囊密封開。 當使用一種依據圖2、3及4之袋囊時，血液被引導入 _一混合袋囊，且如上述處理，不同處在於混合室並不構成 儲存袋囊之部分，而是提供爲一單獨之袋囊。在單獨之混 合袋囊連結至儲存袋囊後，血液如已說明過地流入初級及 次級儲存室。在儲存室塡注完畢後，混合袋囊便和儲存袋 囊分離，而儲存袋囊則以前述方式處理。 14 本紙張尺度適用中國國家標準<CNS)A4規格<210 X 297公釐） -----------·裝--------訂---------^9 (請先閱讀背面之注意事項再填寫本頁) 477696 A7 B7 _____ ----. " 一 " ' 五、發明說明（1$) f請先閱讀背面之注意事項再填寫本頁) 當使用依照圖4之袋囊系統時’初級和次級儲存室在 和混合室分離後，最好設置於一單獨之袋囊中，且可選擇 性地藉由切離的方式和連接管分離。此袋囊可包括一或多 個隔室，各適於包容一或多個初級儲存室及相連之次級儲 存室。隔室可藉由熔接給予分隔。 於所有四個圖式中，次級儲存室大致皆爲矩形。然而 此僅爲一種範例，其他的形狀亦可適用。 即使由各圖式顯示一袋囊中之初級及次級儲存室，各 自具有相同的尺寸及形狀，應可了解’一袋囊中初級及次 級儲存室之尺寸及形狀係可各不相同的。 .如圖1及圖3所示，混合室較佳地是提供有雙重熔接 ，然而其他之實施例，例如三重熔接，或雙摺層單熔接亦 爲適當之方式。 圖5顯示儲存室之另一種實施例，其中初級儲存室 (61)經由一接頭(63)連接至次級儲存室(65)，次級儲存室在 塡注完血液後以束帶(talurites)(62)和其他次級儲存室及初 級儲存室相互密封開。夾子(64)用以將儲存室和連接管相 密封開。 15 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐）V. Description of the invention (p) 48 Primary storage chamber 49 Joint 50 Secondary storage chamber 51 Mechanism βΐ Primary storage chamber 63 Joint 64 Clip 65 Secondary storage chamber Figure 1 shows a bag system according to the present invention, which includes a bag system A double-welding (5) mixing chamber (1), and an inlet (11) having a tube (3), one end of the tube (3) is provided with a connector (4) 'for connection with a needle tube for collecting blood. Two spring locks ⑵ and ⑹ are arranged at the entrance (11) and the exit (12) of the mixing chamber ⑴. The storage bag (13) is connected to the mixing chamber (1) through a tube (14) provided with a clip. The storage bag (13) includes ten primary storage chambers (8) and ten secondary storage chambers ( 9). Connect the tubes (10) to each other. The dotted line shows where the pouch system is welded, which is used to seal the storage compartments after the pouch system is full of blood. When a pouch system according to Fig. 1 is used, blood is introduced into the mixing chamber (1), where the previously necessary agents are preferably already present, but the spring lock (2) is closed and the pouch The system is upside down or shaken to properly mix the ingredients. Then, the snap lock (6) is opened, and the blood mixture flows into the storage bag (13) 'to fill the maximum number of primary and secondary storage chambers. To ensure that the blood mixture can properly flow into the storage chamber, the person handling the pouch system preferably squeezes or shakes the pouch slightly to make the blood mixture flow more easily. 12 This paper size is applicable to China National Standard (CNS) A4 (21〇X 297). ------------------- ^ --------- (Please read the precautions on the back before filling this page) 477696 A7 __B7 _ V. Description of the invention ((I) When all the blood mixture contained in the mixing chamber (1) has flowed into the storage bag (13), clip (7) Is closed and the mixing chamber ⑴ has been removed. Then, the connecting tube (10) is closed, for example by welding, immediately before the bag system has been filled or at least immediately before freezing the bag. If suitable welding equipment is available, or The bag system can be placed at a temperature where no bacteria multiply within approximately 24 hours and transported to the equipment performing the welding during that time, and the welding can be performed there. Figure 1 shows a bag system according to the present invention. In a preferred embodiment, the mixing chamber constitutes a part of the bag system. In such a bag system according to the present invention, the mixing chamber is included as a part of the bag system. After the blood is introduced into the pouch system, the blood is transferred from one pouch to another pouch. The risk is minimized. This pouch system also ensures that only a minimal amount of blood is lost or destroyed during the collection of stored blood. This is the case when there is very little blood from the umbilical cord and placenta. The characteristics are extremely important. As shown in Figure 1, the primary storage chamber and the connecting pipe constitute a specific form. However, this is only an exemplary form, and there are many suitable forms, such as shown in Figures 2 and 3 The important idea is that the form is designed so that it can fill as many storage compartments as possible, even if only a small amount of blood can be obtained. Figure 2 shows a storage bag according to the present invention, which has a An opening (21) for receiving blood is provided with a snap lock (22) and a clip (23). The pouch includes twelve primary storage chambers (24) and twelve secondary storage chambers (25) They communicate with each other through the connecting tube (26). The dotted line shows where the pouches are welded to seal each storage room after being filled with blood. 13 This paper size applies to China National Standard (CNS) A4 (210 X 297 mm)- ---------- Install -------- Order --- ------ (Please read the notes on the back before filling out this page) 477696 A7 ______ Β7__ _ 5. Description of the invention (b) This bag can be used to connect with the mixed bag, the blood drawn and the aforementioned Agent liquid phase mixing. One by one----------------------------------------- -------------------------------------------------- --- FIG. 3 shows a hybrid pouch (31) and a storage pouch (35) according to the present invention. The mixing bag (31) includes a mixing chamber (32) surrounded by a double welding (33), and has a joint (34) for connecting with the storage bag (35). The storage bag (35) has an opening (36) for receiving blood, which is provided with a snap lock (37) and a clip (38). The pouch (35) includes ten primary storage chambers (39) and ten secondary storage chambers (40), which communicate with each other through a connecting pipe (41). The dotted line shows where the pouch is welded to seal the storage compartments after the blood is injected. FIG. 4 shows a pouch system according to the present invention, which includes a mixing chamber (41), the mixing chamber (41) has a mechanism (51) for hanging the mixing chamber on a suitable bracket or similar device, An opening for receiving and discharging blood, and including another port (43) for injecting additives and / or withdrawing blood for testing. The pouch system further includes four primary storage chambers (48), which communicate with each other, and communicate with the mixing chambers through the connecting pipe (46) and the joints (45, 49), and each primary storage chamber is connected two times. Class storage room (50). Each of the primary storage compartments may be sealed to each other by clips (47), or sealed from the mixing bag. When using a pouch according to Figures 2, 3 and 4, blood is guided into a mixed pouch and processed as described above, except that the mixing chamber does not form part of the storage pouch, but is provided as a separate pouch. Bag. After a separate hybrid pouch is attached to the storage pouch, blood flows into the primary and secondary storage compartments as described. After the storage chamber has been filled, the mixing bag is separated from the storage bag, and the storage bag is processed in the manner described above. 14 This paper size applies to Chinese National Standards < CNS) A4 Specifications < 210 X 297 mm) ----------- · Installation -------- Order ------ --- ^ 9 (Please read the precautions on the back before filling this page) 477696 A7 B7 _____ ----. &Quot; 一 " 'V. Description of the invention (1 $) f Please read the precautions on the back before (Fill in this page) When using the bag system according to Figure 4, the 'primary and secondary storage chambers are separated from the mixing chamber, preferably in a separate bag, and can optionally be cut off Separate from the connection tube. The pouch may include one or more compartments, each adapted to contain one or more primary storage compartments and connected secondary storage compartments. The compartment can be partitioned by welding. In all four drawings, the secondary storage chamber is generally rectangular. However, this is only an example, and other shapes are applicable. Even though the drawings show that the primary and secondary storage chambers in a pouch have the same size and shape, it should be understood that the sizes and shapes of the primary and secondary storage chambers in a pouch can be different . As shown in Figures 1 and 3, the mixing chamber is preferably provided with double welding, but other embodiments, such as triple welding, or double-fold single welding are also appropriate. FIG. 5 shows another embodiment of the storage chamber, wherein the primary storage chamber (61) is connected to the secondary storage chamber (65) via a connector (63), and the secondary storage chamber is talurites after blood injection. (62) Sealed from other secondary storage rooms and primary storage rooms. The clip (64) is used to seal the storage chamber and the connection pipe. 15 This paper size applies to China National Standard (CNS) A4 (210 X 297 mm)