JP2021504003A - 血漿処理システムの流体回路をプライミングするシステムおよび方法 - Google Patents
血漿処理システムの流体回路をプライミングするシステムおよび方法 Download PDFInfo
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Abstract
Description
本出願は、優先権について、「動脈プラークの退行を引き起こすシステムおよび方法」と題する、2017年11月22日に出願された米国仮特許出願第62/589,919号に依拠している。
・1つまたは複数の流体投入部:
・流体投入部からの流体および溶媒投入部からの溶媒を混合するのに用いることができる、1つまたは複数の混合デバイス;
・流体、溶媒、または流体−溶媒混合物の流れを制御するのに用いることができる、1つまたは複数の弁;
・流体投入部からの流体の流れを制御し、また、溶媒投入部からの溶媒の流れを制御するのに用いることができる、1つまたは複数の弁;
・チューブを通って分離器へ向かう流体−溶媒混合物の流れを制御するのに用いることができる、1つまたは複数の弁;
・バルク溶媒の分離を実行するための1つまたは複数の分離器およびそれに関連する弁;
・フローストリーム内に配置して溶媒抽出デバイスへの第2の層の流れを制御する、1つまたは複数の圧力センサおよび/または弁;
・1つまたは複数のグルコース投入部およびそれに関連する弁;
・1つまたは複数の生理食塩水投入部およびそれに関連する弁;
・1つまたは複数の溶媒抽出デバイス;および/または
・蠕動ポンプ、ローラポンプ、または回転ポンプとすることができる、1つまたは複数のポンプ、が含まれる。
1.プライミング:システムをプライミングしてプロセスで利用できるように、該システムがプライミングに対応できるかどうか。
2.連続的または断続的な流れ:システムが本質的に連続的である(血漿を連続的に分離し、並行して代わりの流体を投入する)必要があるか、または、離散的な量の流体(バッチフロー)を処理できるかどうか。
3.閉ループ制御:システムを監視する必要があるか、またはプロセスによって検証することができるかどうか。
4.可変流量:システムが様々な範囲の流量に対応できるかどうか。
5.ホールドアップ容積:これは、プロセスが完了した後に回路内に残る流体または血液の量である。患者に戻される血漿が過剰に希釈されないように、患者の体外に置く血液または流体を常時できるだけ少なくすることが望ましい。
6.混合制御:システムが、混合のレベル、速度または程度を制御できるかどうか。
7.血漿範囲:システムが、異なる種類の血漿(正常な血漿、高LDL血漿、高トリグリセリド血漿、およびその他の種類の血漿を含む)に対応できるかどうか。
8.パッケージ要件:病院または血液バンクが、システムおよびその関連する構成要素(使い捨て品およびハードウェアを含む)の設置面積に対応できるかどうか。
9.環境要件:システムが、動作時の騒音/振動およびハードウェアの耐久性に関して様々な設定で展開できるかどうか(例えば、血液バンクまたは病院で展開できるかどうか)。
10.費用:システムを費用対効果の高い方法で製造できるかどうか(例えば、高コストでなく、高精度コネクタを有する)。
、実験的な脱脂プロセスを実験室で行った。図4の表400に示した結果について、簡単に説明する。表400を参照すると、第1の列402には、行ごとに異なる実施形態が列挙されている。各実施形態は、脱脂の程度に影響するパラメータの固有の組合せに対応している。第2の列404には、各実施形態で用いられた血漿の種類が列挙されている。血漿の種類は、ヒトまたはウシの血漿から選択された。列406には、各実施形態で用いられた血漿量(ミリリットル)が列挙されている。列408には、用いた溶媒の種類が列挙されている。ほとんどの実施形態において、溶媒の種類は、n−ブタノールおよびDiPeのいずれかである。列410には、使用されたn−ブタノールの割合が列挙されており、これは、溶媒比の指標としても推論され得るものである。列412には、各実施形態で用いられた溶媒対血漿比が列挙されている。列414には、各実施形態で用いられた混合方法の種類が列挙されている。列416には、混合プロセスが実施された時間が列挙されている。列418には、血漿と溶媒とを分離するために選択された方法が列挙されている。列420には、各実施形態において分離プロセスが実行された時間が列挙されている。列422には、各実施形態で適用された遠心力の大きさが列挙されている。最後に、列424には、処理された血漿中の残存脂質の割合における、各実施形態の変化を示す結果が列挙されている。
ヒト由来の血漿約10ミリリットル(ml)を使用した。この血漿を、n−ブタノール/DiPE溶媒と混合した。溶媒対血漿比は、2:1であった。ロッカーテーブルを使用して、混合操作を約5分間実行した。563XGの遠心力を約2分間加え、脱脂された血漿を溶媒から分離した。溶媒中のn−ブタノールの割合を0%〜40%の範囲で変化させることの効果は、溶媒中のn−ブタノールの量の増加に伴い、残存脂質が次第に減少することである。
別の同様の実験では、ウシ血漿10mlを、n−ブタノールを25%含有するn−ブタノール/DiPE溶媒と混合した。ロッカーテーブルを使用して、約5分間、混合物を混合した。563XGの遠心力を約2分間加え、脱脂された血漿を溶媒から分離した。溶媒対血漿比を0.25〜10の範囲で変化させることの効果は、比が小さいほど、具体的には1〜2の範囲で、脱脂溶液中の脂質濃度が最も低くなることである。
別の同様の実験では、ヒト血漿10mlを、n−ブタノールを25%含有するn−ブタノール/DiPE溶媒と混合した。溶媒対血漿比は、2:1であった。ロッカーテーブルとボルテックスを使用して、混合物の異なるサンプルを混合した。重力分離を約5分間行い一部のサンプルを分離し、さらに563XGの遠心力を約2分間加え、脱脂された血漿を残りのサンプルの溶媒から分離した。異なる混合方法を用いること、および分離に用いる両方の方法(重力および遠心分離)の混合時間を変化させることによる効果は、脱脂された血漿の残存脂質の濃度にばらつきがあることである。
さらに別の同様の実験では、ヒト血漿10mlを、n−ブタノールを25%含有するn−ブタノール/DiPE溶媒と混合した。溶媒対血漿比は、2:1であった。ロッカーテーブルを用いて、約5分間、混合物を混合した。ある範囲の遠心力を約2分間加え、脱脂された血漿を溶媒から分離した。分離に用いる遠心力を変化させることによる効果は、脱脂された血漿中に残存する脂質の濃度である。
Claims (20)
- 少なくとも第1の流体流路、第2の流体流路、第3の流体流路、および第4の流体流路を含む、血漿処理システムをプライミングする方法であって:
第1の流体回路を洗い流すステップであって、当該第1の流体回路が、第1の流体の供給源、当該第1の流体の供給源と前記第1の流体流路との間に配置された第1の弁、前記第1の流体流路と前記第2の流体流路との間に配置された第2の弁、前記第2の流体流路と前記第3の流体流路との間に配置された第1のポンプ、ならびに前記第3の流体流路と流体接続する第1の廃棄物容器によって定義される、第1の流体回路を洗い流すステップと;
前記第2の弁を閉じ、それにより、前記第2の流体流路、第3の流体流路、および第1の廃棄物容器への流体の流れを阻止するステップと;
前記第1の弁を閉じ、それにより、前記第1の流体の供給源から前記第1の流体流路への前記第1の流体の流れを阻止するステップと;
前記第1の流体流路と前記第4の流体流路との間に配置された第3の弁を開くステップと;
第2の流体の供給源と前記第1の流体流路との間に配置された第4の弁を開くステップと;
前記第2の弁を開き、それにより、前記第2の流体流路、第3の流体流路、および第1の廃棄物容器への流体の流れを可能にするステップと、を含む方法。 - 前記第1の流体が生理食塩水である、請求項1に記載の方法。
- 前記第2の流体が生理食塩水である、請求項1に記載の方法。
- 前記第1の流体回路が、血漿の供給源、溶媒の供給源、または生成血漿容器と流体接続しない、請求項1に記載の方法。
- 前記血漿処理システムが、前記第2の流体流路に沿って配置されたコネクタチューブをさらに含む、請求項1に記載の方法。
- 前記第2の弁を開いた後、前記第2の流体流路をクランプし、前記コネクタチューブを取り外すステップをさらに含む、請求項5に記載の方法。
- 前記コネクタチューブを取り外した後、当該コネクタチューブの代わりに溶媒抽出デバイスを挿入するステップをさらに含む、請求項6に記載の方法。
- 前記溶媒抽出デバイスが木炭カラムである、請求項7に記載の方法。
- 前記血漿処理システムが、前記第3の流体流路と前記第1の廃棄物容器との間に配置された第5の弁をさらに含む、請求項1に記載の方法。
- 前記第4の流体流路が分離器と流体接続する、請求項1に記載の方法。
- 少なくとも第1の流体流路、第2の流体流路、第3の流体流路、および第4の流体流路を含む、血漿処理システムをプライミングする方法であって:
第1の流体回路を洗い流すステップであって、当該第1の流体回路が、第1の流体の供給源、当該第1の流体の供給源と前記第1の流体流路との間に配置された第1の弁、前記第1の流体流路と前記第2の流体流路との間に配置された第2の弁、前記第2の流体流路と前記第3の流体流路との間に配置された第1のポンプ、ならびに前記第3の流体流路と流体接続する第1の廃棄物容器によって定義される、第1の流体回路を洗い流すステップと;
第2の流体回路を洗い流すステップであって、当該第2の流体回路が、第2の流体の供給源、前記第1の流体流路と前記第4の流体流路との間に配置された第3の弁、および前記第2の流体の供給源と前記第1の流体流路との間に配置された第4の弁によって定義され、前記第2の弁を閉じ、それにより、前記第2の流体流路、第3の流体流路、および第1の廃棄物容器への流体の流れを阻止し、前記第1の弁を閉じ、それにより、前記第1の流体の供給源から前記第1の流体流路への前記第1の流体の流れを阻止し、前記第3の弁を開き、かつ前記第4の弁を開く、第2の流体回路を洗い流すステップと、を含む方法。 - 前記第1の流体が生理食塩水であり、前記第2の流体が生理食塩水である、請求項11に記載の方法。
- 前記第1の流体回路が、血漿の供給源、溶媒の供給源、または生成血漿容器と流体接続しない、請求項11に記載の方法。
- 前記血漿処理システムが、前記第2の流体流路に沿って配置されたコネクタチューブをさらに含む、請求項11に記載の方法。
- 前記第2の弁を閉じた後、一定時間待機してから前記第2の弁を開き、それにより、前記第2の流体流路、第3の流体流路、および第1の廃棄物容器への流体の流れを可能にすることをさらに含む、請求項11に記載の方法。
- 前記第2の弁を開いた後、前記第2の流体流路をクランプし、前記コネクタチューブを取り外すことをさらに含む、請求項14に記載の方法。
- 前記コネクタチューブを取り外した後、当該コネクタチューブの代わりに溶媒抽出デバイスを挿入する、請求項16に記載の方法。
- 前記溶媒抽出デバイスが木炭カラムである、請求項17に記載の方法。
- 前記第3の流体流路と前記第1の廃棄物容器との間に配置された第5の弁をさらに含む請求項11の記載の方法。
- 前記第4の流体流路が分離器と流体接続する、請求項11に記載の方法。
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