JP2020121167A - 体液採取用流体分流機構 - Google Patents
体液採取用流体分流機構 Download PDFInfo
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Abstract
Description
Claims (39)
- 患者から体液サンプルを獲得するデバイスであって、
近位端部分及び遠位端部分を含み、かつ、前記近位端部分及び前記遠位端部分の間に内部空間を規定するハウジングであって、前記患者に流体的に結合されるように構成された入口ポートと、サンプルリザーバに流体的に結合されるように構成された出口ポートと、を有するハウジングと、
前記内部空間内に配置され、前記患者から抜き取られる第1体積の体液を受け取りかつ隔離するように構成された体液リザーバと、
前記ハウジング内に配置され、第1内腔及び第2内腔を規定する流れ制御機構であって、前記入口ポートが前記体液リザーバに流体連通するように配置されて体液が前記入口ポートから前記第1内腔を通り前記体液リザーバまで流れることができる第1形態から、前記入口ポートが前記出口ポートに流体連通するように配置されて前記体液が前記入口から前記第2内腔を通り前記出口ポートまで流れることができる第2形態まで、回転移動するように構成された流れ制御機構と、
前記流れ制御機構に動作可能に結合され、使用者によって駆動されると前記体液リザーバ内に負圧を発生させるように構成されたアクチュエータであって、前記第1体積の体液が前記患者から前記体液リザーバ内に受け取られた後、前記流れ制御機構を前記第1形態から前記第2形態まで回転させるようにさらに構成されたアクチュエータと、を備えるデバイス。 - 前記アクチュエータが、使用者によって駆動されると前記体液リザーバ内に前記負圧を発生させるように第1距離移動するようにさらに構成される、請求項1に記載のデバイス。
- 前記アクチュエータが、前記流れ制御機構を前記第1形態から前記第2形態まで回転させるように第2距離移動するようにさらに構成される、請求項2に記載のデバイス。
- 前記アクチュエータが、第1方向に移動して前記体液リザーバ内に前記負圧を発生させるように、かつ、第2方向に移動して、前記第1方向の移動によって前記体液リザーバ内で発生した前記負圧を低減させるように構成される、請求項1に記載のデバイス。
- 前記アクチュエータが、前記体液リザーバ内で発生した前記負圧を前記使用者が調整することを可能にするように構成される、請求項1に記載のデバイス。
- 患者から体液サンプルを獲得するデバイスであって、
近位端部分及び遠位端部分を含み、かつ、前記近位端部分及び前記遠位端部分の間に内部空間を規定するハウジングと、
前記ハウジング内に移動可能に配置されたアクチュエータであって、封止部材と、前記封止部材によって少なくとも部分的に規定された体液リザーバと、を含み、使用者によって駆動されると前記体液リザーバ内に負圧を発生させるように構成されたアクチュエータと、
前記ハウジング内に配置された分流器であって、前記患者に流体的に結合されるように構成された入口ポートと、前記体液リザーバに流体的に結合可能であるように構成された第1出口ポートと、サンプルリザーバに流体的に結合されるように構成された第2出口ポートと、を有する分流器と、
前記分流器内に配置され、第1内腔及び第2内腔を規定する流れ制御機構であって、前記入口ポートが前記第1出口ポートに流体連通するように配置されて体液が前記入口ポートから前記第1内腔を通り前記第1出口ポートまで流れることができる第1形態と、前記入口ポートが前記第2出口ポートに流体連通するように配置されて前記体液が前記入口から前記第2内腔を通り前記第2出口ポートまで流れることができる第2形態との間で、回転移動するように構成された流れ制御機構と、を備えるデバイス。 - 前記アクチュエータが、第1体積の体液が前記患者から前記体液リザーバ内に受け取られた後、前記流れ制御機構を前記第1形態から前記第2形態まで回転させるようにさらに構成される、請求項6に記載のデバイス。
- 前記アクチュエータが、使用者によって駆動されると、前記体液リザーバ内に前記負圧を発生させるように第1距離移動し、かつ、前記流れ制御機構を前記第1形態から前記第2形態まで回転させるように第2距離移動するように構成される、請求項7に記載のデバイス。
- 前記アクチュエータが、第1方向に移動して前記体液リザーバ内に前記負圧を発生させるように、かつ、第2方向に移動して、前記第1方向の移動によって前記体液リザーバ内で発生した前記負圧を低減させるように構成される、請求項6に記載のデバイス。
- 前記アクチュエータが、前記封止部材に動作可能に結合されたプランジャをさらに含む、請求項6に記載のデバイス。
- 前記アクチュエータが、前記プランジャに動作可能に結合されたばねをさらに含み、前記ばねが、前記アクチュエータが使用者によって駆動された時に起動力に応じて圧縮するように構成される、請求項10に記載のデバイス。
- 前記ばねが、前記起動力が取り除かれた時に伸張して反作用力を及ぼすように構成される、請求項11に記載のデバイス。
- 前記ばねが、前記体液リザーバ内に発生した前記負圧を前記使用者が調整することを可能にするように構成される、請求項12に記載のデバイス。
- 患者から体液サンプルを獲得するデバイスであって、
近位端部分及び遠位端部分を含み、かつ、前記近位端部分及び前記遠位端部分の間に内部空間を規定するハウジングであって、前記患者に流体的に結合されるように構成された入口ポートと、サンプルリザーバに流体的に結合されるように構成された出口ポートと、を有するハウジングと、
前記ハウジング内に配置され、第1内腔及び第2内腔を規定する流れ制御機構であって、前記入口ポートが前記ハウジングによって少なくとも部分的に規定された体液リザーバに流体連通するように配置されて体液が前記入口ポートから前記第1内腔を通り前記体液リザーバまで流れることができる第1形態と、前記入口ポートが前記出口ポートに流体連通するように配置されて前記体液が前記入口から前記第2内腔を通り前記出口ポートまで流れることができる第2形態との間で、回転移動するように構成された流れ制御機構と、
前記ハウジング内に移動可能に配置され、前記流れ制御機構に動作可能に結合されたアクチュエータであって、使用者によって駆動されると前記体液リザーバ内に負圧を発生させるように構成され、前記第1体積の体液が前記患者から前記体液リザーバ内に受け取られた後、前記流れ制御機構を前記第1形態から前記第2形態まで回転させるようにさらに構成されたアクチュエータと、を備えるデバイス。 - 前記アクチュエータが、前記流れ制御機構を前記第1形態から前記第2形態まで回転させるように構成された起動機構を含む、請求項14に記載のデバイス。
- 前記起動機構が第1組の突起を含み、前記流れ制御機構が第2組の突起を含み、前記第1組の突起が、前記流れ制御機構を前記第1形態から前記第2形態まで回転させるように前記第2組の突起と動作可能に係合するように構成される、請求項15に記載のデバイス。
- 前記アクチュエータが、前記使用者が前記アクチュエータを第1位置から第2位置まで移動させた時、前記体液リザーバ内に前記負圧を発生させるようにさらに構成されている、請求項14に記載のデバイス。
- 前記アクチュエータが、前記使用者が前記アクチュエータを前記第2位置から第3位置まで移動させた時、前記流れ制御機構を前記第1形態から前記第2形態まで回転させるようにさらに構成される、請求項17に記載のデバイス。
- 前記アクチュエータが起動機構を含み、前記流れ制御機構が一組の突起を含み、前記起動機構が、前記使用者が前記アクチュエータを前記第2位置から第3位置まで移動させた時、前記流れ制御機構を前記第1形態から前記第2形態まで回転させるように前記突起の組と動作可能に係合するように構成される、請求項18に記載のデバイス。
- 患者から体液サンプルを獲得するデバイスであって、
近位端部分及び遠位端部分を含み、かつ、前記近位端部分及び前記遠位端部分の間に内部空間を規定するハウジングであって、前記患者に流体的に結合されるように構成された入口ポートを有するハウジングと、
前記内部空間内に移動可能に配置されたシール部材と、
前記内部空間内に配置されかつ前記シール部材によって少なくとも部分的に規定された体液リザーバであって、前記患者から抜き取られる第1体積の体液を受け取りかつ隔離するように構成された体液リザーバと、
前記ハウジング内に移動可能に配置された流れ制御機構であって、前記体液が前記入口ポートから前記流れ制御機構を通り前記体液リザーバまで流れることができる第1形態と、前記体液リザーバが前記入口ポートから流体的に隔離される第2形態との間で移動するように構成された流れ制御機構と、
前記シール部材にかつ前記流れ制御機構に動作可能に結合されたアクチュエータであって、前記シール部材を第1位置から第2位置まで移動させて前記体液リザーバ内に負圧を発生させるように構成されたばねを含み、前記第1体積の体液が前記患者から前記体液リザーバ内に受け取られた後、前記流れ制御機構を前記第1形態から前記第2形態まで移動させるようにさらに構成されているアクチュエータと、を備えるデバイス。 - 前記アクチュエータに動作可能に結合された絞りボタンであって、前記絞りボタンの使用者による操作に基づき、前記ばねが前記シール部材を前記第1位置から前記第2位置まで移動させる速度を変更するように構成された絞りボタンをさらに備える、請求項20に記載のデバイス。
- 前記流れ制御機構が第1制御部材及び第2制御部材を含み、前記第2制御部材が第1内腔及び第2内腔を規定し、前記流れ制御機構が、前記入口ポートが前記体液リザーバに流体連通するように配置されて体液が前記入口ポートから前記第1内腔を通り前記体液リザーバまで流れることができる第1形態と、前記入口ポートがサンプルリザーバに流体連通するように配置されて前記体液が前記入口から前記第2内腔を通り前記サンプルリザーバまで流れることができる第2形態との間で、回転移動するように構成される、請求項20に記載のデバイス。
- 前記第1制御部材が、前記第2制御部材によって規定された溝内に移動可能に配置された突起を含み、前記突起が、前記ばねが前記シール部材を前記第1位置から前記第2位置まで移動させる際に前記溝内で移動するように構成される、請求項22に記載のデバイス。
- 前記突起が、前記ばねが前記シール部材を前記第2位置から第3位置まで移動させる時に前記第2制御部材を回転させるように構成される、請求項23に記載のデバイス。
- 患者から体液サンプルを獲得するデバイスであって、
近位端部分及び遠位端部分を含み、かつ、前記近位端部分及び前記遠位端部分の間に内部空間を規定するハウジングであって、前記患者に流体的に結合されるように構成された入口ポートと、サンプルリザーバに流体的に結合されるように構成された出口ポートと、を有するハウジングと、
前記ハウジング内に配置された流れ制御機構であって、第1制御部材及び第2制御部材を含み、前記第2制御部材が第1内腔及び第2内腔を規定し、前記ハウジングによって少なくとも部分的に規定された体液リザーバに前記入口ポートが流体連通するように配置されて体液が前記入口ポートから前記第1内腔を通り前記体液リザーバまで流れることができる第1形態と、前記入口ポートが前記出口ポートに流体連通するように配置されて前記体液が前記入口から前記第2内腔を通り前記出口ポートまで流れることができる第2形態との間で、回転移動するように構成される、流れ制御機構と、
前記ハウジング内に移動可能に配置されかつ前記第1制御部材に動作可能に結合されたアクチュエータであって、使用者によって駆動されると前記体液リザーバ内に負圧を発生させるように構成され、第1体積の体液が前記患者から前記体液リザーバ内に受け取られた後、前記第2制御部材を前記第1形態から前記第2形態まで回転させるようにさらに構成されたアクチュエータと、を備えるデバイス。 - 前記アクチュエータが、前記第1制御部材に動作可能に結合されかつ前記第2制御部材を前記第1形態から前記第2形態まで回転させるように構成された起動機構を含む、請求項25に記載のデバイス。
- 前記アクチュエータが、前記使用者が前記アクチュエータを第1位置から第2位置まで移動させた時、前記体液リザーバ内に前記負圧を発生させるようにさらに構成される、請求項25に記載のデバイス。
- 前記アクチュエータが、前記使用者が前記アクチュエータを前記第2位置から第3位置まで移動させた時、前記第2制御部材を前記第1形態から前記第2形態まで回転させるようにさらに構成される、請求項27に記載のデバイス。
- 前記第1制御部材に結合された起動機構であって、前記使用者が前記アクチュエータを前記第2位置から第3位置まで移動させた時、前記アクチュエータと動作可能に係合するように構成された突起を含む起動機構をさらに備える、請求項28に記載のデバイス。
- 非経口的採取デバイスを用いて体液サンプルを獲得する方法であって、前記デバイスが、前記患者の体内に挿入されるように構成された内腔を有する針と、前記針に流体的に結合可能な体液リザーバと、を含む、方法であり、
前記患者の体内に前記デバイスの針を挿入するステップと、
前記針と前記体液リザーバとの間に流体連結を確立するステップと、
アクチュエータを第1距離移動させて、前記体液リザーバ内に負圧を発生させかつ所定体積の体液を抜き取るステップと、
前記アクチュエータを第2距離移動させて、流れ制御機構と係合させかつ前記流れ制御機構を第1形態から第2形態まで回転させるステップであって、前記第1形態が、体液が前記針から第1流路を通って前記体液リザーバまで流れることを可能にするように動作可能であり、前記第2形態が、体液が前記針から第2流路を通ってサンプルリザーバまで流れることを可能にするように動作可能である、ステップと、を含む方法。 - 前記アクチュエータを前記第1距離移動させるステップが、前記アクチュエータに対して第1方向に起動力を加えることを含む、請求項30に記載の方法。
- 前記起動力を解除することにより、前記アクチュエータが、前記第1方向とは反対の第2方向に移動し、前記体液リザーバ内で発生する前記負圧を低減させることができる、請求項31に記載の方法。
- 前記第2形態で、前記アクチュエータを第3距離移動させて、前記第2流路を通る前記サンプルリザーバまでの体液の流量を低減させるステップをさらに含む、請求項30に記載の方法。
- 前記第2形態で、前記アクチュエータを第3距離移動させて、制御部材と係合させかつ前記第2流路を変形させて、前記第2流路を通る前記サンプルリザーバまでの体液の流量を低減させるステップをさらに含む、請求項33に記載の方法。
- 非経口的採取デバイスを用いて体液サンプルを獲得する方法であって、前記デバイスが、前記患者の体内に挿入されるように構成された内腔を有する針と、前記針に流体的に結合可能な体液リザーバと、を含む、方法であり、
前記患者の体内に前記デバイスの針を挿入するステップと、
前記針と前記体液リザーバとの間に流体連通を確立するステップと、
アクチュエータに第1起動力を加えて、前記体液リザーバ内に負圧を発生させかつ所定体積の体液を抜き取るステップと、
前記アクチュエータに加えられる前記第1起動力を低減させて、前記体液リザーバ内で発生する前記負圧を低減させるステップと、
前記アクチュエータに第2起動力を加えて、前記流れ制御機構と係合させ、前記流れ制御機構を第1形態から第2形態に移動させるステップであって、前記第1形態が、体液が前記針から第1流路を通って前記体液リザーバまで流れることを可能にするように動作可能であり、前記第2形態が、体液が前記針から第2流路を通ってサンプルリザーバまで流れることを可能にするように動作可能である、ステップと、を含む方法。 - 前記第1起動力が、前記アクチュエータを第1距離第1方向に移動させて前記体液リザーバ内に前記負圧を発生させる、請求項35に記載の方法。
- 前記第1起動力を低減させることにより、前記アクチュエータが前記第1方向とは反対の第2方向に移動して、前記体液リザーバ内で発生する前記負圧を低減させることができる、請求項36に記載の方法。
- 前記第2起動力が、前記アクチュエータを第2距離前記第1方向に移動させて前記流れ制御機構を前記第1形態から前記第2形態まで移動させる、請求項35に記載の方法。
- 前記第2形態で、第3起動力を加えて、前記第2流路を通る前記サンプルリザーバへの体液の流量を低減させるステップをさらに含む、請求項35に記載の方法。
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