JP2019510238A - 血液染色パッチ、それを使用する血液検査のための方法及びデバイス - Google Patents
血液染色パッチ、それを使用する血液検査のための方法及びデバイス Download PDFInfo
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Abstract
【選択図】 なし
Description
本開示の一態様は、物質を保管する能力があるパッチを提供することである。
本開示の一態様によれば、血液中に存在する染色標的を染色するために構成された染色試薬、並びに、染色試薬が含有されたマイクロキャビティを形成するメッシュ構造で提供され、血液が配置される反応領域と接触し、含有される染色試薬の一部が反応領域に送達されるように構成されたメッシュ構造体を含む、染色パッチが提供される。
1.1 パッチの意味
本出願において、液体物質を管理するためのパッチが開示される。
1.2.1 配置
図1及び図2は、本出願によるパッチの一例を示す図である。本出願によるパッチを、図1及び図2を参照して、以下に説明する。
上記の説明のように、本出願によるパッチPAは、メッシュ構造体NSを含むことができる。パッチPAは、メッシュ構造体NSによって、液体物質SBを管理することができる。パッチPAは、パッチPAに捕捉された液体物質SBが、その固有の特性の少なくともいくつかを維持することを、可能にし得る。
上述の特性に起因して、本出願によるパッチは、いくつかの有用な機能を有し得る。言い換えれば、液体物質SBを捕捉することによって、パッチは、液体物質SBの挙動に関与するようになり得る。
2.1.1 意味
上記で説明するように、本出願によるパッチPAは、液体物質SBを捕捉することができる。言い換えれば、パッチPAは、リザーバーとしての機能を果たすことができる。
本出願において、パッチPAは、上述の特性に起因して、標的物質を捕捉することができる。パッチPAは、所定の範囲内で、外部環境の変化に対する抵抗性を有していてもよい。この方法において、パッチPAは、物質が捕捉された状態を維持することができる。捕捉される標的である液体物質SBは、三次元メッシュ構造体NSを占めていてもよい。
図3及び図4は、本出願によるパッチの機能の一例として、反応空間を提供することを示す図である。
2.2.1 意味
物質の移動は、パッチPA及び外部領域の間で生じてもよい。物質は、パッチPAからパッチPAの外部領域に移動してもよく、又は外部領域からパッチPAに移動してもよい。
物質が移動可能な状態において、パッチPAに捕捉された液体物質SB及び/又は外部領域に配置された物質の間で、流れが生じてもよい。物質が移動可能な状態において、パッチPAに捕捉された液体物質SB及び外部領域の間で、物質の移動が生じてもよい。
物質が移動不可能な状態において、パッチPAに捕捉された液体物質SB及び外部領域の間で、物質の移動は生じなくてもよい。しかしながら、物質の移動は、パッチPAに捕捉された液体物質SBにおいて、及び外部領域に配置された外部物質において、それぞれ、生じてもよい。
2.2.4.1 送達
本出願において、上述の特性に起因して、パッチPAは、パッチPAに捕捉された液体物質SBの少なくとも一部を、所望の外部領域に送達することができる。物質の送達は、満足された所定の条件に起因する、パッチPAからの、パッチPAに捕捉された液体物質SBの一部の分離を指してもよい。液体物質SBの一部の分離は、パッチPAによって影響を受ける領域から、物質の一部の抽出、放出又は解放を指してもよい。これは、パッチPAの上述のチャネリング機能に従属する概念であり、パッチPAの外部へのパッチPAに配置された物質の移動(送達)を定義するものとして理解することができる。
説明の前に、本出願によるパッチPAの機能の中で、「吸収」は、いくつかの実施形態において、上述の「送達」と同様に使用し得ることに留意すべきである。例えば、物質が、物質間の濃度の相違に起因して移動する場合において、「吸収」は、液体物質SBの濃度、特に、添加物質ASの濃度を変化させて、物質が移動する方向を制御し得る点で「送達」と同様であり得る。「吸収」は、パッチPAとの物理的な接触の解放によって、物質の移動及び選択的な吸収を制御する点で、「送達」と同様であり得、これは、本出願が関連する当業者によって、明確に理解され得る。
上述の特性に起因して、本出願によるパッチPAは、所望の領域の環境条件を調整する機能を果たすことができる。パッチPAは、所望の領域に、パッチPAに起因する環境を提供することができる。
本出願によるパッチPAは、上述のパッチPAの機能を適切に適用することによって、実施して、様々な機能を果たすことができる。
パッチPAは、物質のために反応領域を提供することができる。言い換えれば、物質の反応は、パッチPAによって影響を受ける空間領域の少なくとも一部で起こり得る。この場合において、物質の反応は、パッチPAに捕捉された液体物質SBの間の反応並びに/又は捕捉された液体物質SB及びパッチPAの外側から提供された物質の間の反応であってもよい。物質のための反応領域の提供は、物質の反応を活性化又は促進することができる。
本明細書の以下において、パッチPAへの吸収の機能及び反応空間の提供の機能(本明細書の以下において、「機能の提供」と称する)が、単一のパッチPAによって果たされると仮定することによって、説明を行う。この場合において、吸収機能及び機能の提供は、同時に果たされる機能、異なる時点で果たされる機能、又は連続して果たされて、別の機能を果たす機能であってもよい。吸収及び機能の提供に加えて他の機能をさらに含むパッチPAは、本実施形態に属するものとして考えることもできる。
本明細書の以下において、少なくとも所定の時間で、パッチPAの含有する機能及び物質のための反応空間の提供の機能が一緒に果たされる実施態様を説明する。より詳細には、パッチPAは、パッチPAに含有される液体物質SBの少なくとも一部が反応するための空間を提供する機能を果たすことができる。
本明細書の以下において、物質の移動経路を提供する機能を果たすパッチPAを説明する。より詳細には、上記で説明するように、パッチPAは、流動性を有する物質を、捕捉、吸収、放出及び/又は含有することができる。物質の移動経路を提供する機能を果たすパッチPAの様々な実施形態は、上述のパッチPAの機能のそれぞれ、又はこれらの組み合わせによって実施することができる。しかしながら、いくつかの実施形態を、よりよい理解のために開示する。
パッチPAは、上述のパッチPAの機能の中で、2.2.4.1項(すなわち、送達に関する項)及び2.2.4.2項(すなわち、吸収に関する項)に説明された機能を果たすために実施され得る。この場合において、吸収機能及び送達機能は、一緒に提供されてもよく、又は連続して提供されてもよい。
パッチPAは、パッチPAの上述の機能の中で、物質の吸収及び放出、並びに、同時に、物質のための反応空間の提供を果たすことができる。この場合において、物質の吸収及び放出、並びに反応空間の提供は、同時に又は連続して行われてもよい。
パッチPAは、単独で使用されてもよく、又は複数のパッチPAが一緒に使用されてもよい。この場合において、一緒に使用することが可能な複数のパッチPAは、複数のパッチPAが連続的に使用される場合、及び複数のパッチPAが同時に使用される場合を含む。
複数のパッチPAが使用される場合、複数のパッチPAは、単一の標的領域TAと接触してもよい。複数のパッチPAは、単一の標的領域TAと接触し、所望の機能を果たすことができる。
複数のパッチPAは、複数の機能を果たすことができる。上記で説明するように、パッチPAは、複数の機能を同時に果たすことができ、パッチPAは、異なる機能を同時に果たすこともできる。しかしながら、実施形態は、上記に限定されず、機能を、組み合わせることもでき、複数のパッチPA中で果たすこともできる。
複数のパッチPAが使用される場合、上記で説明するように、複数のパッチPAは、複数の機能を果たすことができる。最初に、パッチPAは、物質の含有、放出及び吸収を同時に行ってもよい。或いは、パッチPAはまた、物質の含有、放出及び吸収を、別々に行ってもよい。しかしながら、実施形態は、これらに限定されず、機能を、組み合わせることもでき、複数のパッチPA中で果たすこともできる。
複数のパッチPAが使用される場合、パッチPAは、物質の含有及び放出、並びに環境の提供を、同時に行ってもよい。或いは、パッチPAは、物質の含有及び放出、並びに環境の提供を、別々に行ってもよい。しかしながら、実施形態は、これらに限定されず、機能は、複数のパッチPAを組み合わせて、果たすこともできる。
4.1 意味
本出願のパッチは、血液検査において使用することができる。血液検査は、被験者の健康状態、疾病又は疾患の存在、疾病又は疾患の進行などを診断するために、血液学的手法に従った、血液についての試験を指す。
4.2.1 全血球算定(CBC)
血液検査の典型例として、CBC(全血球算定)を挙げることができる。CBSは、血球、すなわち、赤血球、白血球及び血小板についての数の情報又は形態の情報を使用する、最も基本的な血液検査の1つであり、疾患の診断、処置及び監視を含む、様々な臨床的適応を有する。
血液検査の別の典型例として、末梢血塗抹標本検査を挙げることができる。末梢血塗抹標本検査は、採取した血液を、スライドガラスに塗抹し、次いで、染色して、顕微鏡によって、血球の数若しくは形態の情報を検査するか、又は血液中の細菌若しくは寄生生物を発見する、検査である。例えば、赤血球は、貧血の識別及び貧血の原因を確定するのに使用されてもよく、白血球は、骨髄異形成症候群、白血病、感染症又は炎症の原因及び巨赤芽球性貧血を確定するのに有益であり得る。また、血小板は、骨髄増殖性疾患、血小板衛星現象などを確定するのに有益である。加えて、血小板は、結核菌などの細菌性病原体、又は血液中に存在する細菌を含む、様々な寄生生物を検出するために使用することもできる。
本出願において、血液検査は、主に、スライドガラスなどのプレートPLに血液を塗抹すること、血液を染色すること、次いで、染色された血液を観察することによって、行うことができる。ここで、様々な染色法を、必要により、使用することができる。例えば、ギムザ染色法、ライト染色法及びギムザ−ライト染色法などのロマノフスキー染色法を、血液の染色において使用することができる。加えて、単染色法、グラム染色法又は細菌学的検査に付随するAFB(チール−ネールゼン)染色法などの染色法、及び子宮頸がん検査において主に使用されるパパニコロウ染色法を、本出願の血液検査において使用することができる。
4.4.1 試料の調製
ここで、血液検査において使用される試料、すなわち、血液の調製を説明する。
本出願において血液検査を行うにあたり、上述のパッチPAを使用することができる。
ここで、本出願の上述のパッチPA及びプレートPLを使用する血液検査を行う方法のいくつかの典型例を説明する。
プレートPLへの血液の塗抹は、様々な方法によって行うことができる。ここで、血液は、単層、又は必要により多層に塗抹されてもよい。
血液の染色は、パッチPAに、プレートPLに塗抹された血液と接触する染色試薬を含ませることによって行ってもよい。塗抹された血液及びパッチPAが接触すると、パッチPAに含まれる染色試薬は、血液に移動し、血液中の、細胞質の内部に存在する顆粒、核、白血球などを染色することができる。
血液についての検査は、染色された血液に関する画像を取得すること及び取得した画像を解析することによって行うことができる。
図40は、本出願による血液検査方法の一例を説明するためのフローチャートを示す。
本出願の一実施形態による血液検査は、プレートPL及びパッチPAを使用する単染色法によって行うことができる。
本出願の血液検査は、染色試薬を含有する染色パッチPAを使用して行うことができる。言い換えれば、パッチPAは、血液中の標的物質と反応し、標的物質を染色する染色試薬を含有することができ、プレートPLに染色試薬を送達することができる。
本実施形態による血液検査方法は、残留物を吸収するために構成された洗浄パッチPAを使用して行うことができる。言い換えれば、本実施形態による血液検査方法において、残留物は、プレートPLと接触し、プレートPLから分離される洗浄パッチPAによって吸収され得る。残留物は、それぞれのパッチに吸収されない残留物を指し、上述の染色パッチPAが、プレートPLと接触し、次いでプレートPLから分離されるときに、除去され得る。
本実施形態による血液検査方法は、緩衝パッチを使用して行うことができる。言い換えれば、緩衝パッチPAは、緩衝液を含有することができ、プレートPLに所定の環境を提供することができる。緩衝パッチPAは、血液検査のそれぞれのステップを容易にする緩衝液を含有することができる。緩衝液は、主に、所望の塩基性の反応に必要な最適のpHを有する緩衝液であってもよい。
本出願の実施形態による血液検査は、プレートPL及びパッチPAを使用するロマノフスキー染色法によって行うことができる。
本出願の実施形態による血液検査は、プレートPL及びパッチPAを使用するグラム染色法によって行うことができる。
本出願の血液検査は、血液検査デバイスを使用して行うことができる。
Claims (20)
- 血液中に存在する染色標的を染色するために構成された染色試薬;並びに
前記染色試薬が含有されたマイクロキャビティを形成するメッシュ構造で提供され、前記血液が配置される反応領域と接触し、含有される染色試薬の一部が前記反応領域に送達されるように構成されたメッシュ構造体
を含む、染色パッチ。 - 前記染色標的を染色するために構成された前記染色試薬が、酸性染色試薬、塩基性染色試薬及び中性染色試薬のうちの少なくとも1つを含む、請求項1に記載の染色パッチ。
- 前記染色試薬が、前記染色標的が蛍光色を発するように構成された蛍光染色試薬を含む、請求項1に記載の染色パッチ。
- 前記染色標的が、血液中に存在する、血球、細菌及び寄生生物のうちの少なくとも1つを含み;
前記染色試薬が、前記染色標的の、細胞質、核及び顆粒のうちの少なくとも1つを染色する、
請求項1に記載の染色パッチ。 - 複数の染色標的が存在し;
前記染色試薬が、前記染色標的の第1の染色標的を染色するために構成された第1の染色試薬、及び前記染色標的の第2の染色標的を染色するために構成された第2の染色試薬を含む、
請求項1に記載の染色パッチ。 - マイクロキャビティを形成し、前記マイクロキャビティに、血液中に存在する染色標的を染色するための染色試薬を含有するように構成されたメッシュ構造体を含むパッチが、前記染色標的の染色による血液検査を行うために使用された、血液検査方法であって、
反応領域に血液を配置するステップ;及び
前記染色試薬を含有するように構成された前記パッチを使用して、前記反応領域に前記染色試薬を提供するステップ
を含む、血液検査方法。 - 前記提供された染色試薬によって染色された前記血液の画像を取得するステップをさらに含む、請求項6に記載の血液検査方法。
- 前記染色標的が、血液中の血球であり;
前記血液検査方法が、画像に基づいて、前記血球の種類の情報、前記血球の数の情報、及び前記血球の形態の情報のうちの少なくとも1つを取得するステップをさらに含む、請求項7に記載の血液検査方法。 - 前記取得された情報に基づいて、全血球算定(CBC)を行うステップをさらに含む、請求項8に記載の血液検査方法。
- 前記染色標的が、血液中の寄生生物又は細菌であり;
前記血液検査方法が、前記寄生生物又は細菌の存在に関する情報、前記寄生生物又は細菌の種類に関する情報、前記寄生生物又は細菌の数に関する情報、及び前記寄生生物又は細菌についての形態の情報のうちの少なくとも1つを取得するステップをさらに含む、請求項6に記載の血液検査方法。 - 前記取得された情報に基づいて、末梢血塗抹標本検査を行うステップをさらに含む、請求項10に記載の血液検査方法。
- 前記血液を配置するステップが、血液をプレートに固定する方法、試料をプレートに塗抹する方法、又は試料をプレートに塗抹し、前記試料を前記プレートに固定する方法のうちのいずれか1つによって行われる、請求項6に記載の血液検査方法。
- 前記パッチを使用して、前記反応領域に前記染色試薬を提供するステップが、
前記パッチを前記反応領域と接触させて、前記染色試薬が前記反応領域に移動可能にすること;及び
前記反応領域から前記パッチを分離すること
を含み、
前記パッチが、前記反応領域から分離されたときに、前記染色標的と反応していない残留染色試薬が、前記反応領域から除去される、
請求項6に記載の血液検査方法。 - 洗浄液を含有するように構成された洗浄パッチを使用して、前記反応領域から、前記反応領域に残留した前記残留染色試薬及び外来物質を吸収するステップをさらに含む、請求項6に記載の血液検査方法。
- 前記パッチを使用して、前記反応領域に前記染色試薬を提供するステップが、
前記染色標的における細胞質及び核のうちのいずれか1つを染色するための第1の染色試薬を含有するように構成された第1のパッチを使用すること、及び前記反応領域に前記第1の染色試薬を提供すること;並びに、
前記染色標的における細胞質及び核のうちの他の1つを染色するための第2の染色試薬を含有するように構成された第2のパッチを使用すること、及び前記反応領域に前記第2の染色試薬を提供すること
を含む、請求項6に記載の血液検査方法。 - 緩衝液を含有するように構成された第1の緩衝パッチを使用して、前記反応領域に最適なpHを提供するステップをさらに含む、請求項15に記載の血液検査方法。
- 前記最適なpHを提供するステップが、前記第1の染色試薬の提供及び前記第2の染色試薬の提供の間の時点、並びに前記第2の染色試薬の提供の後の時点のうちの少なくとも1つの時点の間に行われる、請求項16に記載の血液検査方法。
- 前記染色パッチが、前記染色標的の細胞質を染色するために構成された前記第1の染色試薬、及び前記染色標的の核を染色するために構成された前記第2の染色試薬を含有し;
前記パッチを使用して、反応領域に染色試薬を提供するステップが、前記染色パッチが、前記染色標的の細胞質及び核の両方を染色するように、前記反応領域に前記第1の染色試薬及び前記第2の染色試薬を提供することを含む、請求項6に記載の血液検査方法。 - 前記第1の染色試薬及び第2の染色試薬を提供するステップの後、緩衝液を含有するように構成された緩衝パッチを使用して、前記反応領域に最適なpHを提供するステップをさらに含む、請求項18に記載の血液検査方法。
- マイクロキャビティを形成するメッシュ構造体を含む、パッチを使用する血液検査デバイスであって、染色標的の染色によって血液検査を行うために、前記マイクロキャビティに、血液中に存在する前記染色標的を染色するための染色試薬を含有するように構成された、血液検査デバイスであって、
血液が配置される反応領域が配置された、プレートをサポートするために構成されたプレートサポーターと;
前記染色試薬が前記反応領域に提供されるように、前記染色試薬を含有及び前記反応領域に対して前記パッチの相対的な位置を制御するために構成された、前記パッチを使用するために構成されたパッチコントローラーと;
血液を検査するために、前記血液中に存在する前記染色標的の染色の結果を検出するために構成された反応検出器と
を備える、血液検査デバイス。
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