JP6450767B2 - 血漿アフェレーシスデバイス - Google Patents
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Description
本発明は、ある程度の割合の循環ガレクチン−3(gal-3)を血液から選択的に除去することを含む、哺乳動物血液のアフェレーシスを実行するためのデバイスに関する。デバイスは、血液からガレクチン−3(又は他のガレクチン)だけでなく、他の潜在的に有害な因子を除去し、哺乳動物患者への血液の還流の際に治療に効果的であるか又は有益である追加的な因子を血液に導入する能力を有する。
ガレクチン−3は、哺乳類において炎症、繊維増多、及び様々な形態の癌を引き起こす機構を説明するために目を向ける種々の研究の焦点になっている。本出願における「哺乳類」によって、出願人は、当然、ヒトを説明しようとするが、イヌ及びネコのようなペット哺乳類、並びにウシ、ウマ、ヤギ、及びブタのような市販の哺乳類を含む、それらの健康に投資するに値する十分な価値の哺乳類もまた説明しようとする。サルなどの高次の哺乳類は、研究モデル並びにペットとなり得るが、同様に、この用語に含まれる。本発明は、当然、ヒトに焦点を合わせる。
本出願は、2011年6月6日に出願された米国特許出願第13/153,648号に関連する。この出願もまた、2013年4月23日に発行された米国特許第8,426,567号に基づく優先権を主張する。両方のこれらの親文書の内容が、参照により本明細書に明白に組み込まれる。米国特許出願第13/153,648号(米国特許公開第US−2011−0294755 A1号)において、改質シトラスペクチン(MCP)、20,000ダルトン以下、好ましくは10,000ダルトンほど、の減少した分子量を有したシトラスペクチンなどの循環Gal-3を結合することができる薬剤の投与を伴う細胞増殖状態、炎症、及び悪化した繊維増多を処理する方法が開示される。MCPは、サンタローザ(カリフォルニア州)のEcoNugenicsから市販され、米国特許第6,274,566号及び第6,462,029号に言及される。
gal-3は、ほぼ30kDaで、すべてのガレクチンのように、β−ガラクトシドの特異的結合を可能にする約130のアミノ酸の炭水化物−認識−結合ドメイン(CRD)を含有する。gal-3は、14番染色体、座q21〜q22に位置する単一の遺伝子LGALS3によってコードされる。このタンパク質は、多数の生物学的プロセスに関与すると示されている。本明細書に記載されるリストは、最近の状況としてのみ例示的であり、gal-3が果たす役割は絶えず明らかにされている。少なくとも部分的に、gal-3がかかわると示されている細胞レベルでの生物学的プロセスとしては、細胞接着、細胞移動、細胞侵入、細胞活性化及び化学誘引、細胞成長及び分化、脈管形成及びアポトーシスが挙げられる。
血漿アフェレーシスのための装置の初期の形態は、米国特許第3,625,212号に記載され、適切なドナーへの処理された血漿及び分離された血液細胞の還流を確実にするための尺度を説明する。米国特許第4,531,932号は、遠心分離によって血漿アフェレーシスに対処し、方法は、迅速かつほぼ連続的なベース上に赤血球細胞を分離するために使用される。米国特許第6,245,038号及び第6,627,151号は、一般に、高分子量タンパク質の除去によって血液粘度を減少させるために、血漿分を分離して、赤血球細胞を最初に除去した後に、患者に処理された血漿を還流する種々の方法を各々説明する。本発明、すなわち本出願の主題は、高分子量タンパク質ではなく、gal-3レベルなどの、ガレクチン循環レベルの減少に焦点を合わせ、又は粘度に直接対処しないが、これらの4つの特許の開示は、本発明において一般的に利用されてもよい利用可能な血漿アフェレーシス技術及び装置のそれらの開示のために、参照により本明細書に組み込まれる。一般的に血漿アフェレーシスを含む、アフェレーシスの進歩は、Asahi MedicalからのPlasmaflo AP-05H及び限外濾過モードの標準的な透析装置のような、高透過性膜を使用した血液透析機器の使用の有効性を実証している。これは、血液吸着応用時に対しても同様である。
本発明の血漿アフェレーシスデバイスは、活性gal-3低減を必要とする、哺乳類の全血から分離された血漿からのgal-3の選択的な除去を提供することによって、技術を進歩させる。同時係属中の、2012年9月28日に出願された米国特許出願第13/863,989号、及び2013年12月27日に出願された第14/141,509号に参照されるように、哺乳類の血流からの活性gal-3の除去は、不必要な炎症に対処する、繊維増多、特に心臓繊維増多によって引き起こされる危険を減少させる、種々の癌の危険又は広がりを減少させる、治療を強化するなどのために遂行され得る。したがって、該血漿アフェレーシスデバイスの重要な条件は、gal-3の選択的な除去である。gal-3を選択的に結合するコンポーネントを通過するように分離された血漿を導くことが、これに影響を与える。このコンポーネントは、gal-3の抗体などのgal-3を確実に結合する材料が物理的に保持された、カラム、容器、又は類似したプラットホームであり得、結果として、血漿が通過する際に、そこに引き込まれるgal-3の有意の画分がカラムに結合される。他の実施形態では、選択的なgal-3除去は、gal-3に結合し、次いで特有の抗体によって、又は、磁荷の選択的な適用により引き離され得る固着された磁粉などの、二次的な手段によって、それ自体容易に除去される材料と機械の導管内の血漿の流れを組み合わせることによって遂行される。
本発明の血漿アフェレーシスデバイスが、図1に一般に描かれる。血液は、通常、末梢又は中心静脈周辺の、静脈カテーテルの挿入によって、哺乳動物患者1002から引き出される。中心静脈は、高い流量を許容し、反復処置には好都合だが、合併症、特に細菌感染の、部位となる場合がある。カテーテルは、それ自体、本発明のデバイスの一部ではなく、通常、操作者、例えば診療所又は病院、によって提供される。カテーテルは、デバイス1000の導管に接続され、正流が、ポンプ1006に支援されて、システムに血液を流通させる。
Claims (14)
- 血漿アフェレーシスを実行するデバイスであり、
哺乳動物患者から引き出された血液がポンプの影響下で移動する第1の導管と、
前記血液の細胞成分を血漿から分離する分離器と、
前記血漿が流れるカラムデバイスであって、処理された血漿を提供するために前記血漿からガレクチン−3(gal-3)を選択的に除去するカラムデバイスと、
前記カラムデバイスの通路に続く前記処理された血漿を受ける第2の導管であって、前記処理された血漿が、前記患者への還流前に、前記分離器において分離された血液細胞と組み合わせられる、第2の導管と、を含むデバイスであって、
前記第1及び第2の導管が、前記患者からの及び前記哺乳動物患者へ戻る前記血液及び血漿の実質的な連続流を提供し、
ガレクチン−3(gal-3)以外の血漿成分の除去のために、少なくとも1つの追加的なカラムデバイスを含む、デバイス。 - 前記患者に戻る前に、前記処理された血漿、分離された血液、又はその両者に治療薬剤を添加することができる少なくとも1つのポートを含む、請求項1に記載のデバイス。
- 前記血漿アフェレーシスの監視及び制御を可能にするために、監視ステーションを更に含む、請求項1に記載のデバイス。
- 前記監視ステーションが、前記分離器及び前記カラムデバイスの自動制御を提供して、脈拍数、酸素飽和度、ECGリズム、及び血圧からなる群から選択される患者インジケータの監視を更に提供する、請求項3に記載のデバイス。
- 前記分離器が、遠心分離機を含む、請求項1に記載のデバイス。
- 前記遠心分離機が、連続流遠心分離機である、請求項5に記載のデバイス。
- 前記分離器が、不連続流分離機である、請求項5に記載のデバイス。
- 前記分離器が、膜血漿分離機である、請求項1に記載のデバイス。
- 前記導管を通過して前記細胞成分を前進させるために、少なくとも1つのポンプを更に含む、請求項1に記載のデバイス。
- B細胞、T細胞、血小板、幹細胞、及びそれらの混合物からなる群から選択される血液成分が改質のために収集されて、次いで前記導管を介して前記患者に還流され得る少なくとも1つのポートを更に含む、請求項1に記載のデバイス。
- 前記カラムデバイスが、内部が提供されたチューブを含み、補助内部が、ガレクチン−3(gal-3)を結合する薬剤を支持する組成物を有し、前記チューブ内の前記血漿が、前記薬剤が見いだされる前記チューブのエリアを通過する、請求項1に記載のデバイス。
- 前記薬剤が、ガレクチン−3(gal-3)を結合するリガンドを含む、請求項10に記載のデバイス。
- 腫瘍壊死因子αを除去するカラムデバイス及び腫瘍増殖因子βを除去するカラムデバイスを含む、請求項1に記載のデバイス。
- 抗凝固剤の添加のために前記分離器の上流にポートを含む、請求項9に記載のデバイス。
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CA2932902A1 (en) | 2015-07-02 |
ES2713388T3 (es) | 2019-05-21 |
EP3086870A1 (en) | 2016-11-02 |
BR112016013876B1 (pt) | 2022-03-22 |
AU2014370393A1 (en) | 2016-06-23 |
JP2017507683A (ja) | 2017-03-23 |
KR20160102440A (ko) | 2016-08-30 |
SG11201604881TA (en) | 2016-08-30 |
MY184230A (en) | 2021-03-29 |
EP3086870B1 (en) | 2019-01-02 |
WO2015099826A1 (en) | 2015-07-02 |
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