JP6854929B2 - 水中運動選手からの汗の捕集および分析のための表皮マイクロ流体センサ - Google Patents
水中運動選手からの汗の捕集および分析のための表皮マイクロ流体センサ Download PDFInfo
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Description
本出願は、本明細書と矛盾しない範囲で、参照により明確に組み込まれている、2017年6月2日に出願された、米国仮特許出願第62/514,468号の優先権の利益を主張するものである。
水中運動選手、または高湿度環境内の運動選手からの汗捕捉および分析は、乾燥陸上の運動選手には存在しない固有の問題のあることを明らかにする。水の表面より下に沈めることで、従来のマイクロ流体汗センサを逆充填し、結果として汗分析を中断する十分な圧力をもたらし得る。高湿度環境は、従来の水に敏感な物質中で水分感知に対する偽陽性も引き起こし得るが、それは、液体水にのみ選択性を有し水蒸気によってトリガーされるからである。本明細書において提供されるのは、高湿度または水域環境から偽陽性なしで汗捕集を行うことを円滑にするデバイス、システム、方法、および材料である。含まれるのは、環境からの逆充填を防ぎ、水蒸気に対する水分センサの感度を下げ、それによって、全体的感度を高め、読み取り誤りまたは偽陽性の危険性を最小限度に抑えるように構成されている設計である。
この例示的なデバイスは、水域環境および乾燥陸上環境における、汗の捕捉、貯蔵、および化学分析のために、および皮膚温度のデジタル測定のために、皮膚に結合される皮膚様または「表皮」マイクロ流体(エピフルイディック)および電子システムの防水加工した組合せからなる。このプラットフォームは、マイクロチャネル、比色化学試薬を収納するチャンバー、ワイヤレス通信および高精度温度感知のための電子機器、参照色マーカーのセット、および皮膚に安全な接着剤を組み込んでいる(図4A)。SISの薄いフラットシートに結合されたポリ(スチレン-イソプレン-スチレン)(SIS)の成形層は、封止されたマイクロ流体システムを画成し、また色マーカーをカプセル封入する(図4B)。本明細書において報告されている設計では、マイクロチャネルは、40巻きを有する円形蛇行幾何学的形状で深さが約220μmであり、各巻きは約60μLの全容積に対して1.5μLの容量を有する。比色試薬は、マイクロチャネルへの汗の充填の程度の視覚的評価を円滑にするための食用色素、または塩化物の濃度を決定するためのクロラニル酸銀懸濁液のいずれかからなる。この試薬は、流入口の近くに構成されているチャンバー内に位置し、汗捕捉中にチャネル内に運ばれる(図4D)。食用色素は、異なる溶解速度を有する赤色および青色の水溶性粒子を含み、デバイスに汗が充填されるときに体積依存の色変化を生み出し、視覚化を円滑にするための手段となる(図4F)。
可撓性磁気ループアンテナ、近距離無線通信(NFC)コンポーネントのセット、およびLEDがデジタル識別コードおよび皮膚温度の読み取り値を伝送するワイヤレスインターフェースからNFC対応デバイス(スマートフォン、タブレットなど)へのユーザ通知のための一モードとして備えられる。NFCコイルを加工するためのプロセスおよび回路設計の詳細は、これらの方法および図15に示されている。SISのコーティングはNFC電子機器をカプセル封入し、これにより、水中に完全に沈められたときでも長期間にわたって堅牢な動作が可能である(図14)。図4Eは、湿潤環境内のNFC電子機器のワイヤレス動作を例示し、光を放射してマイクロ流体層に通すときのLEDを示している。
この実施例において説明されているデバイス構成は、システムのマイクロ流体コンポーネントを介して累積損失、汗の発汗速度および塩化物濃度の測定を可能にする。NFCコンポーネントは、皮膚温度の測定を可能にする。水泳および自転車漕ぎでデバイスを身に着けている2人の被検体の写真は、それぞれ、図16Aおよび図16Bである。ここで、デバイスは、肘の先端部から約7cm離れて前腕腹側正中線上にある。レーザーパターン化された皮膚に安全なアクリル接着剤により、デバイスを皮膚に結合する(これ以降、タイプ1接着剤と称する)(図16C)。パターン化された開口部は、閉塞した汗腺の領域を約25%縮小し、それによって、典型的にはパターン化されていない接着剤層で観察される、隣接する汗腺の閉塞により局所的発汗速度を高める汗放出における代償効果を大部分排除する。この結果、汗捕集の信頼性および再現性が改善される。パターン化された(タイプ1)およびパターン化されていない(タイプ2)で捕集された汗の体積の比較が図12に示されている。タイプ1の接着剤によるデバイスからの結果と発泡体吸収剤パッドで得られた結果および%体重損失の測定結果との比較は、それぞれ、局所的汗体積損失および大域的汗体積損失を測定するための2つの最も一般的な方法と突き合わせてなされる妥当性確認として使用される。このエピフルイディックデータは、水泳および自転車漕ぎに携わっている被検体に対する吸収剤パッドで得られた結果とのよい相関関係(R2=0.74)を示している(図16D)。エピフルイディックデバイスで捕集された汗体積も、%全体重損失と十分に妥当な相関を有している(R2=0.63、図16E)。実際問題として、水泳中の重量損失の信頼性の高い測定は、水(飲料水など)の増加および損失が不注意で、制御されることなく生じるので可能でない。
本出願全体を通してのすべての参考文献、たとえば、発行されたもしくは付与された特許または同等の文書を含む特許文書、特許出願公開、および非特許文献または他の資料は、それぞれの参照が本出願の開示と少なくとも部分的に矛盾していない範囲で、参照により個別に組み込まれているかのように、全体が参照により本明細書に組み込まれる(たとえば、部分的に矛盾している参照は、参照の部分的に矛盾する部分を除いて参照によって組み込まれる)。
110 接着剤層
120 キャップ層
130 マイクロ流体流入口導管ネットワーク
140 マイクロ流体流出口ネットワーク
150 生体液流入口
160 比色センサ
170 リザーバ
200 温度センサ
210 LED
220 NFCコイル
Claims (14)
- 湿潤環境内で使用するための表皮マイクロ流体システムであって、
可撓性基板と、
前記可撓性基板内に少なくとも部分的に埋め込まれるか、または前記可撓性基板によって支持されるマイクロ流体流入口導管ネットワークと、
使用時に皮膚表面から生体液を前記マイクロ流体流入口導管ネットワークに供給するために前記マイクロ流体流入口導管ネットワークに流体的に接続される生体液流入口と、
前記マイクロ流体流入口導管ネットワークに流体的に接続され、前記マイクロ流体流入口導管ネットワークからガス逆圧を逃すように構成され、使用時に前記湿潤環境から前記表皮マイクロ流体システムの液体完全性を維持するサイズを有するマイクロ流体流出口導管ネットワークと、
各リザーバチャンバーが前記マイクロ流体流入口導管ネットワークと流体的に接続される、複数のリザーバチャンバーと、
前記マイクロ流体流入口導管ネットワークと流体的に連通するように位置決めされた複数の比色センサであって、前記複数の比色センサの各々は、生体液特性を測定するために固有のリザーバチャンバー内に位置決めされる、複数の比色センサと、
を備える表皮マイクロ流体システム。 - キャップ層および接着剤層をさらに備え、
前記キャップ層は、前記可撓性基板の皮膚対向または外向き表面を覆い、
および、接着剤層は、前記キャップ層の露出した表面の少なくとも一部上に位置決めされ、前記接着剤層は、前記生体液流入口と流体的に整列された第2の補助流入口を備える、請求項1に記載のシステム。 - 前記可撓性基板および前記キャップ層の各々は、ポリジメチルシロキサン(PDMS)、ポリウレタン、セルロース紙、セルローススポンジ、ポリウレタンスポンジ、ポリビニルアルコールスポンジ、シリコーンスポンジ、ポリスチレン、ポリイミド、SU-8、ワックス、オレフィンコポリマー、ポリメチルメタクリレート(PMMA)、ポリカーボネート、ポリ塩化ビニル、ポリ(スチレン-イソプレン-スチレン)、キトサン、およびこれらの任意の組合せからなる群から選択される物質を独立して含み、および/または、前記接着剤層は、医療グレードのアクリルを含む、請求項2に記載のシステム。
- 前記可撓性基板は第1の直径を有し、前記キャップ層は前記可撓性基板の前記第1の直径と異なる第2の直径を有し、前記キャップ層の前記第2の直径は、前記可撓性基板の前記第1の直径より小さい、請求項2に記載のシステム。
- 前記可撓性基板は、500μmから2mmの範囲から選択された平均厚さを有し、
および/または、前記キャップ層は、50μmから1mmの範囲から選択された平均厚さを有し、
および/または、前記接着剤層は、10μmから100μmの範囲から選択された平均厚さを有する、請求項2に記載のシステム。 - 前記少なくとも1つの比色センサは、前記マイクロ流体流入口導管ネットワークと流体的に連通する色素であり、前記色素の少なくとも一部は、前記生体液が前記マイクロ流体流入口導管ネットワークに入ったときに前記生体液と混合され、それによって前記マイクロ流体流入口導管ネットワークを通る流体流れの視覚的指示をもたらす、請求項1から5のいずれか一項に記載のシステム。
- 前記複数の比色センサの各々は、前記複数のリザーバチャンバーまたは前記マイクロ流体流入口導管ネットワーク内の前記生体液の存在を示す色素を含み、
および/または、前記複数の比色センサの各々は、生体液の体積もしくは量、流量、組成、またはこれらの任意の組合せの定量化のための1つまたは複数の呈色応答試薬を含み、
前記1つまたは複数の呈色応答試薬は、液体水、または前記生体液中の1つもしくは複数の検体と反応する指示試薬であり、
および/または、前記呈色応答試薬は湿度に対して敏感でなく、
および/または、前記1つまたは複数の呈色応答試薬は、前記複数のリザーバチャンバーのうちのそれぞれのリザーバチャンバー内に固定化され、
および/または、前記1つまたは複数の呈色応答試薬のうちの少なくとも1つは、クロラニル酸銀懸濁液であり、
および/または、前記1つまたは複数の呈色応答試薬は、色素、CoCl2、グルコースオキシダーゼ、ペルオキシダーゼ、ヨウ化カリウム、乳酸デヒドロゲナーゼ、ジアフォラーゼ、ホルマザン色素、水銀イオンもしくは鉄イオンとの2,4,6-トリ(2-ピリジル)-s-トリアジン(TPTZ)錯体、2,2'-ビシンコニン酸、1,10-フェナントロリン、pH指示薬、クロラニル酸銀、およびこれらの任意の組合せからなる群から選択される、請求項1に記載のシステム。 - 前記マイクロ流体流出口導管ネットワークは、周囲の前記湿潤環境からの液体逆充填を防ぐように選択された特性寸法を有する生体液流出口を備え、前記生体液流出口は、0.6mm2以下の断面積を有し、
および/または、前記生体液流入口は、前記マイクロ流体流出口導管ネットワークへの生体液の進入を円滑にするように構成されている特性寸法を有し、前記生体液流入口は、1mm2以上の断面積を有する、請求項1から7のいずれか一項に記載のシステム。 - 前記マイクロ流体流出口導管ネットワークの1つまたは複数の断面積の各々は、0.1mm2から0.3mm2の範囲から選択され、
および/または、前記マイクロ流体流入口導管ネットワークは、500μm以下の深さおよび100μmから800μmの範囲から選択された幅を有する、請求項1から8のいずれか一項に記載のシステム。 - 前記マイクロ流体流入口導管ネットワークは、時間に依存した、前記生体液の捕集、分析、または貯蔵を可能にするように構成されている1つもしくは複数の受動的弁または1つもしくは複数の能動的弁をさらに備え、
前記受動的弁または能動的弁の少なくとも一部は、方向選択弁、選択性を有する超吸収性ポリマー(SAP)弁、疎水性弁、またはこれらの組合せであり、
および/または、前記受動的弁または能動的弁の少なくとも一部は、リザーバまたはチャネルに前記生体液が充填された後に閉じるように構成され、それによって、前記充填されたリザーバもしくはチャネルから前記生体液の損失もしくは放出を防ぐ、請求項1から9のいずれか一項に記載のシステム。 - 前記複数のリザーバチャンバーは、直列構成の前記マイクロ流体流入口導管ネットワークの長さに沿って均等に分布する、請求項1から10のいずれか一項に記載のシステム。
- 前記マイクロ流体流入口導管ネットワークは、前記複数のリザーバチャンバーの各々を共通の流入口導管に単一の接続点において流体的に接続する複数の流入口チャンバー導管と共通の流入口導管を備え、
および、前記マイクロ流体流出口導管ネットワークは、前記複数のリザーバチャンバーの各々を周上の共通の流出口に複数の流出口接続点において流体的に接続する複数のチャンバー導管を有する周上の共通の流出口導管をさらに備え、前記複数のチャンバー導管の各々は、チャンバー狭窄接続部においてリザーバチャンバーに接続し、
および、前記共通の流入口導管は、前記可撓性基板の内部領域内に位置決めされ、前記周上の共通の流出口導管は、前記可撓性基板の外部領域内に位置決めされ、前記複数のリザーバチャンバーは前記共通の流入口導管と前記周上の共通の流出口導管との間に延在する、請求項1から11のいずれか一項に記載のシステム。 - 温度センサ、ワイヤレスデバイス、および少なくとも1つの発光ダイオード(LED)のうちの少なくとも1つをさらに備える、請求項1から12のいずれか一項に記載のシステム。
- 前記温度センサは、前記可撓性基板内に埋め込まれるか、または前記可撓性基板によって支持され、前記システムの着用者の体温を提示し、
および/または、前記ワイヤレスデバイスは、送信機、受信機、またはその両方であり、
および/または、前記ワイヤレスデバイスは、近距離通信(NFC)コイルであり、
および/または、前記ワイヤレスデバイスは、ワイヤレス給電され、
および/または、前記発光ダイオード(LED)は、前記生体液に関するフィードバックを前記システムの着用者に提供する、請求項13に記載のシステム。
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