JP7413582B2 - サンプル採取のための装置、システム及び方法 - Google Patents
サンプル採取のための装置、システム及び方法 Download PDFInfo
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- JP7413582B2 JP7413582B2 JP2023042278A JP2023042278A JP7413582B2 JP 7413582 B2 JP7413582 B2 JP 7413582B2 JP 2023042278 A JP2023042278 A JP 2023042278A JP 2023042278 A JP2023042278 A JP 2023042278A JP 7413582 B2 JP7413582 B2 JP 7413582B2
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Description
[0001] 本願は、2017年1月10日に出願された米国仮特許出願第62/444,764号、及び2017年3月8日に出願された米国仮特許出願第62/468,906号の利益を主張し、両方とも、参照によりその全体が本明細書に組み込まれる。
[0058] 本明細書中で言及されるすべての刊行物、特許、及び特許出願は、あたかもそれぞれの個々の刊行物、特許、又は特許出願が具体的かつ個別に参照により組み込まれることが示されるのと同程度に参照により本明細書に組み込まれる。
一部の実施形態では、真空チャンバの容積V1は好ましくは約10cm3であり、堆積チャンバの容積V2は好ましくは約6cm3である。真空チャンバ及び堆積チャンバの容積は、2つのチャンバを分離している分離界面、例えば箔が穿刺されたときに両方のチャンバ内の圧力が所望の値に等しくなるように設計することができる。例えば、真空チャンバは、約-12psigの初期開始真空圧力を有することができ、V1対V2の比は、箔が穿刺された後に両方のチャンバ内の均等化圧力が約-4psigになるように構成することができる。例えば1:1、1:2、1:3など、任意の比のV1:V2が考えられ得る。
無線通信チャネルの例は、ブルートゥース(登録商標)、WiFi、近距離無線通信(NFC)、3G、及び/又は4Gネットワークを含むことができる。真空及び/又は穿刺要素を作動させるための信号は、1つ以上の通信チャネルを介してユーザ端末から装置100に遠隔で送信することができる。
表1:全体真空局所吸引採血法の吸引時間
Claims (72)
- 対象から血液を採取し保存する装置であって、
開口部を有する凹部を含むハウジングと、
前記ハウジング内の真空チャンバであって、前記真空チャンバが、真空の初期状態を有し、前記真空の作動によって前記真空チャンバと前記凹部の間に流体連通を確立して、前記対象の皮膚を前記凹部内に引き込むように構成され、前記凹部が、前記皮膚を引き込むための吸引空洞として機能し、真空下で前記凹部によって囲まれた前記皮膚の体積が、約0.4cm3から約4.0cm3の範囲であり、前記凹部と接触している前記皮膚の表面積が、約3.2cm2~約7.2cm2の範囲であり、前記凹部が、増大した毛管圧差の下で、増加した体積の前記血液を採取させることを可能にするように構成されたサイズ又は形状を有し、前記血液の前記増加した体積が、前記凹部に引き込まれる前記皮膚の体積及び/又は表面積に依存する、真空チャンバと、
前記対象の前記皮膚を貫通するために前記開口部を通って延びることができ、前記皮膚が前記凹部に引き込まれている間に前記血液を採取することを可能にする、1つ以上の穿刺要素と、
前記血液を採取及び保存するための1つ以上のマトリックスを保持するように構成されたカートリッジを受容するように構成されたカートリッジチャンバと
を備え、
前記カートリッジが、カートリッジポートを介して前記カートリッジチャンバ内の出力ポートに取り外し可能に結合され、
前記真空が、前記真空チャンバの壁に設けられた流体バリアを破断することによって作動し、前記流体バリアが破断すると、前記真空チャンバと前記凹部の間に前記流体連通が確立される、装置。 - 前記真空チャンバ内の前記真空の前記初期状態が、-27.6kPaから-103.4kPaの範囲の圧力を有する、請求項1に記載の装置。
- 前記装置が、前記1つ以上の穿刺要素による穿刺後に、前記対象から前記血液を少なくとも30μL/分の平均流量で引き込んで採取するように構成される、請求項1に記載の装置。
- 前記装置が、前記血液を少なくとも150μL/分の平均流量で引き込んで採取し、前記平均流量を、少なくとも150~300μLの前記血液が採取されるまで維持するように構成される、請求項1に記載の装置。
- 前記真空チャンバからの前記真空の作動時に、(1)前記真空の圧力と、(2)前記サイズ又は形状を有する前記凹部とが、前記皮膚が前記凹部に実質的に一致することを可能にするように構成され、その結果、前記凹部の表面が、前記凹部内に引き込まれる前記皮膚と実質的に接触する、請求項1に記載の装置。
- 前記凹部の表面積が、前記開口部の面積の少なくとも10倍である、請求項1に記載の装置。
- 前記凹部の前記表面積が約75mm2~約2900mm2の範囲であり、前記開口部の前記面積が約1.5mm2~約30mm2の範囲である、請求項6に記載の装置。
- 前記開口部の直下の前記皮膚の面積が、前記凹部内に引き込まれる前記皮膚の総面積の少なくとも3分の2である、請求項1に記載の装置。
- 前記開口部の直下の前記皮膚の前記面積が、前記凹部内に引き込まれる前記皮膚の前記総面積の少なくとも5分の1である、請求項8に記載の装置。
- 前記凹部が、約1.0cm3~約5.0cm3の範囲の容積を有する凹状の空洞を含む、請求項1に記載の装置。
- 前記凹部が、約10mmから約60mmの範囲の基部直径、及び約3mmから約30mmの範囲の高さを有する球形キャップの形状である、請求項1に記載の装置。
- 前記開口部が、前記球形キャップの頂点にある、請求項11に記載の装置。
- 前記凹部が、前記皮膚への真空吸引力を向上させ、かつ真空漏れを減らすように構成された1つ以上のフィレットを含む、請求項1に記載の装置。
- 前記1つ以上のフィレットが前記凹部の周囲に沿って連続的に延びる、請求項13に記載の装置。
- 前記1つ以上のフィレットが、前記皮膚が前記凹部に引き込まれるときに前記皮膚と接触する、請求項13に記載の装置。
- 前記皮膚が前記真空によって前記凹部内に引き込まれ、1秒未満で前記凹部を完全に満たす、請求項1に記載の装置。
- 前記装置が、接着剤及び前記真空を使用して前記対象の前記皮膚上の所定の位置に支持され保持される、請求項1に記載の装置。
- 前記装置が、(a)前記凹部の前記サイズ又は形状及び/又は(b)真空圧力に応じた速度で前記血液を採取するように構成される、請求項1に記載の装置。
- 前記装置が、3分未満で前記対象から175μL~300μLの血液を採取することができる、請求項1に記載の装置。
- 前記装置が、重力を使用して前記血液の前記採取を強化する位置又は向きで、前記対象の腕の上部に使用するように構成される、請求項1に記載の装置。
- 前記真空チャンバが、前記真空の前記作動の前には前記凹部と流体連通しない、請求項1に記載の装置。
- 前記真空チャンバが隔壁を含み、前記隔壁を通って空気が前記真空チャンバから引き出されて前記真空の初期状態をもたらす、請求項1に記載の装置。
- 前記隔壁が、気密性の可撓性材料を含む、請求項22に記載の装置。
- 前記ハウジングが、前記カートリッジチャンバを含む、請求項1に記載の装置。
- 前記カートリッジが前記カートリッジチャンバ内に受容されると、封止が前記カートリッジを封止する、請求項1に記載の装置。
- 対象から血液を採取し保存する装置であって、
開口部を有する凹部を含むハウジングと、
前記ハウジング内の真空チャンバであって、前記真空チャンバが、真空の初期状態を有し、前記真空の作動によって前記真空チャンバと前記凹部の間に流体連通を確立して、前記対象の皮膚を前記凹部内に引き込むように構成され、前記凹部が、前記皮膚を引き込むための吸引空洞として機能し、真空下で前記凹部によって囲まれた前記皮膚の体積が、約0.4cm 3 から約4.0cm 3 の範囲であり、前記凹部と接触している前記皮膚の表面積が、約3.2cm 2 ~約7.2cm 2 の範囲であり、前記凹部が、増大した毛管圧差の下で、増加した体積の前記血液を採取させることを可能にするように構成されたサイズ又は形状を有し、前記血液の前記増加した体積が、前記凹部に引き込まれる前記皮膚の体積及び/又は表面積に依存する、真空チャンバと、
前記対象の前記皮膚を貫通するために前記開口部を通って延びることができ、前記皮膚が前記凹部に引き込まれている間に前記血液を採取することを可能にする、1つ以上の穿刺要素と、
前記血液を採取及び保存するための1つ以上のマトリックスを保持するように構成されたカートリッジを受容するように構成されたカートリッジチャンバと
を備え、
前記カートリッジが、カートリッジポートを介して前記カートリッジチャンバ内の出力ポートに取り外し可能に結合され、
前記カートリッジが、前記血液を採取及び保存するための前記1つ以上のマトリックスと、
前記1つ以上のマトリックスと流体連通するように構成された1つ以上の吸収パッドとを含み、
前記1つ以上の吸収パッドが、過剰な血液を保持するように構成される、装置。 - 対象から血液を採取し保存する装置であって、
開口部を有する凹部を含むハウジングと、
前記ハウジング内の真空チャンバであって、前記真空チャンバが、真空の初期状態を有し、前記真空の作動によって前記真空チャンバと前記凹部の間に流体連通を確立して、前記対象の皮膚を前記凹部内に引き込むように構成され、前記凹部が、前記皮膚を引き込むための吸引空洞として機能し、真空下で前記凹部によって囲まれた前記皮膚の体積が、約0.4cm 3 から約4.0cm 3 の範囲であり、前記凹部と接触している前記皮膚の表面積が、約3.2cm 2 ~約7.2cm 2 の範囲であり、前記凹部が、増大した毛管圧差の下で、増加した体積の前記血液を採取させることを可能にするように構成されたサイズ又は形状を有し、前記血液の前記増加した体積が、前記凹部に引き込まれる前記皮膚の体積及び/又は表面積に依存する、真空チャンバと、
前記対象の前記皮膚を貫通するために前記開口部を通って延びることができ、前記皮膚が前記凹部に引き込まれている間に前記血液を採取することを可能にする、1つ以上の穿刺要素と、
前記血液を採取及び保存するための1つ以上のマトリックスを保持するように構成されたカートリッジを受容するように構成されたカートリッジチャンバと
を備え、
前記カートリッジが、カートリッジポートを介して前記カートリッジチャンバ内の出力ポートに取り外し可能に結合され、
前記カートリッジが、前記血液を採取及び保存するための2つ以上のマトリックスを含み、
前記2つ以上のマトリックスが、2つ以上のスペーサによって分離される、装置。 - 前記カートリッジが、前記血液を採取及び保存するための2つのマトリックスを有する、請求項1に記載の装置。
- 前記2つ以上のマトリックスが、前記血液が前記2つ以上のマトリックスの間及びそれに沿って吸い上がることを可能にする構成で配置される、請求項27に記載の装置。
- 前記2つ以上のマトリックスが互いに実質的に平行に配置される、請求項27に記載の装置。
- 前記2つ以上のマトリックスが、間隙によって隔てられている、請求項27に記載の装置。
- 前記間隙が約0.5mmである、請求項31に記載の装置。
- 前記2つ以上のマトリックスのそれぞれが、少なくとも60μLの血液を採取することができる、請求項27に記載の装置。
- 前記2つ以上のスペーサが、前記2つ以上のマトリックスの間に配置されて、毛細管現象及び吸上げを介して血液が流れることができるチャネルを形成する、請求項27に記載の装置。
- 前記2つ以上のマトリックスのそれぞれが、約75μLの血液を保持及び維持するように構成される、請求項27に記載の装置。
- 前記カートリッジが、前記2つ以上のマトリックスと流体連通するように構成された1つ以上の吸収パッドを含み、前記1つ以上の吸収パッドが、少なくとも100μLの過剰な血液を保持するように構成される、請求項27に記載の装置。
- 前記カートリッジが、対象又はユーザによって、前記カートリッジを前記カートリッジチャンバ内に挿入するか、又は前記カートリッジを前記カートリッジチャンバから取り外すように使用されるように構成された、前記カートリッジを支持するカートリッジホルダに設けられたカートリッジタブを含む、請求項1に記載の装置。
- 前記1つ以上のマトリックスが紙を含む、請求項1に記載の装置。
- 前記紙がセルロースを含む、請求項38に記載の装置。
- 前記血液が前記カートリッジ内に流入して採取されるときに、対象又はユーザが採血の進行を監視することを可能にするように構成された窓をさらに含む、請求項1に記載の装置。
- 前記ハウジングが、前記カートリッジを受容するように構成された前記カートリッジチャンバを含み、前記窓が、前記カートリッジチャンバの長手方向軸と平行である、請求項40に記載の装置。
- 対象から血液を採取し保存する装置であって、
開口部を有する凹部を含むハウジングと、
前記ハウジング内の真空チャンバであって、前記真空チャンバが、真空の初期状態を有し、前記真空の作動によって前記真空チャンバと前記凹部の間に流体連通を確立して、前記対象の皮膚を前記凹部内に引き込むように構成され、前記凹部が、前記皮膚を引き込むための吸引空洞として機能し、真空下で前記凹部によって囲まれた前記皮膚の体積が、約0.4cm3から約4.0cm3の範囲であり、前記凹部と接触している前記皮膚の表面積が、約3.2cm2~約7.2cm2の範囲であり、前記凹部が、増大した毛管圧差の下で、増加した体積の前記血液を採取させることを可能にするように構成されたサイズ又は形状を有し、前記血液の前記増加した体積が、前記凹部に引き込まれる前記皮膚の体積及び/又は表面積に依存する、真空チャンバと、
前記対象の前記皮膚を貫通するために前記開口部を通って延びることができ、前記皮膚が前記凹部に引き込まれている間に前記血液を採取することを可能にする、1つ以上の穿刺要素と、
カートリッジを受容するように構成された、前記ハウジング内のカートリッジチャンバと、
カートリッジであって、
前記カートリッジチャンバに取り外し可能に結合されたカートリッジポート、
前記血液を採取及び保存するための、互いに実質的に平行に配置された2つの紙マトリックスであって、毛細管現象及び吸上げを介して前記血液が流れることができるチャネルを形成する1つ以上のスペーサによって分離された、2つの紙マトリックス、
前記1つ以上の紙マトリックスと流体連通するように構成され、かつ過剰な血液を保持するように構成された1つ以上の吸収パッド、及び
対象又はユーザによって、前記カートリッジを前記カートリッジチャンバ内に挿入するか、又は前記カートリッジを前記カートリッジチャンバから取り外すように使用されるように構成された、前記カートリッジを支持するカートリッジホルダに設けられたカートリッジタブ
を含む、カートリッジと、
前記カートリッジが前記カートリッジチャンバ内にあるときに前記カートリッジを封止する、封止と、
前記血液が前記カートリッジ内に流入して採取されるときに、対象又はユーザが採血の進行を監視することを可能にするように構成された窓であって、前記カートリッジチャンバの長手方向軸と平行な窓と
を備える、装置。 - 前記真空チャンバ内の前記真空の前記初期状態が、-27.6kPaから-103.4kPaの範囲の圧力を有する、請求項42に記載の装置。
- 前記装置が、前記1つ以上の穿刺要素による穿刺後に、前記対象から前記血液を少なくとも30μL/分の平均流量で引き込んで採取するように構成される、請求項42に記載の装置。
- 前記装置が、前記血液を少なくとも150μL/分の平均流量で引き込んで採取し、前記平均流量を、少なくとも150~300μLの前記血液が採取されるまで維持するように構成される、請求項42に記載の装置。
- 前記真空チャンバからの前記真空の作動時に、(1)前記真空の圧力と、(2)前記サイズ又は形状を有する前記凹部とが、前記皮膚が前記凹部に実質的に一致することを可能にするように構成され、その結果、前記凹部の表面が、前記凹部内に引き込まれる前記皮膚と実質的に接触する、請求項42に記載の装置。
- 前記凹部の表面積が、前記開口部の面積の少なくとも10倍である、請求項42に記載の装置。
- 前記凹部の前記表面積が約75mm2~約2900mm2の範囲であり、前記開口部の前記面積が約1.5mm2~約30mm2の範囲である、請求項47に記載の装置。
- 前記開口部の直下の前記皮膚の面積が、前記凹部内に引き込まれる前記皮膚の総面積の少なくとも3分の2である、請求項42に記載の装置。
- 前記開口部の直下の前記皮膚の前記面積が、前記凹部内に引き込まれる前記皮膚の前記総面積の少なくとも5分の1である、請求項49に記載の装置。
- 前記凹部が、約1.0cm3~約5.0cm3の範囲の容積を有する凹状の空洞を含む、請求項42に記載の装置。
- 前記凹部が、約10mmから約60mmの範囲の基部直径、及び約3mmから約30mmの範囲の高さを有する球形キャップの形状である、請求項42に記載の装置。
- 前記開口部が、前記球形キャップの頂点にある、請求項52に記載の装置。
- 前記凹部が、前記皮膚への真空吸引力を向上させ、かつ真空漏れを減らすように構成された1つ以上のフィレットを含む、請求項42に記載の装置。
- 前記1つ以上のフィレットが前記凹部の周囲に沿って連続的に延びる、請求項54に記載の装置。
- 前記1つ以上のフィレットが、前記皮膚が前記凹部に引き込まれるときに前記皮膚と接触する、請求項54に記載の装置。
- 前記皮膚が前記真空によって前記凹部内に引き込まれ、1秒未満で前記凹部を完全に満たす、請求項42に記載の装置。
- 前記装置が、接着剤及び前記真空を使用して前記対象の前記皮膚上の所定の位置に支持され保持される、請求項42に記載の装置。
- 前記装置が、(a)前記凹部の前記サイズ又は形状及び/又は(b)真空圧力に応じた速度で前記血液を採取するように構成される、請求項42に記載の装置。
- 前記装置が、3分未満で前記対象から175μL~300μLの血液を採取することができる、請求項42に記載の装置。
- 前記装置が、重力を使用して前記血液の前記採取を強化する位置又は向きで、前記対象の腕の上部に使用するように構成される、請求項42に記載の装置。
- 前記真空チャンバが、前記真空の前記作動の前には前記凹部と流体連通しない、請求項42に記載の装置。
- 前記真空が、前記真空チャンバの壁に設けられた流体バリアを破断することによって作動し、前記流体バリアが破断すると、前記真空チャンバと前記凹部の間に前記流体連通が確立される、請求項42に記載の装置。
- 前記真空チャンバが隔壁を含み、前記隔壁を通って空気が前記真空チャンバから引き出されて前記真空の初期状態をもたらす、請求項42に記載の装置。
- 前記隔壁が、気密性の可撓性材料を含む、請求項64に記載の装置。
- 前記カートリッジが前記カートリッジチャンバ内に受容されると、封止が前記カートリッジを封止する、請求項42に記載の装置。
- 前記2つの紙マトリックスが、前記1つ以上のスペーサを使用して間隙によって隔てられている、請求項42に記載の装置。
- 前記間隙が約0.5mmである、請求項67に記載の装置。
- 前記2つの紙マトリックスのそれぞれが、少なくとも60μLの血液を採取することができる、請求項42に記載の装置。
- 前記2つの紙マトリックスのそれぞれが、約75μLの血液を保持及び維持するように構成される、請求項42に記載の装置。
- 前記1つ以上の吸収パッドが、少なくとも100μLの前記過剰な血液を保持するように構成される、請求項42に記載の装置。
- 前記2つの紙マトリックスがセルロースを含む、請求項42に記載の装置。
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