JP2016510670A - 医療用流体カセット漏れ検出方法およびデバイス - Google Patents
医療用流体カセット漏れ検出方法およびデバイス Download PDFInfo
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Abstract
Description
血液透析(「HD」)時に、患者の血液を透析装置のダイアライザーに通しながら透析液もダイアライザーに通す。ダイアライザー内の半透膜は、血液をダイアライザー内の透析液から分離し、透析液と血流との間で拡散および浸透交換を行わせることができる。膜一面にわたるこれらの交換の結果、尿およびクレアチニンのような溶質を含む老廃物が血液から除去される。これらの交換は、血液中のナトリウムおよび水等の他の物質の濃度も調節し、この方法で、透析装置は血液を洗浄するための人工腎臓として働く。
いくつかの実施態様では、医療用流体カセット(例えば、PD流体カセット)が漏れているか判定する方法は、力を医療用流体カセットに加えるステップと、医療用流体カセットの第1の圧力を測定するステップと、その後加えられた力を医療用流体カセットから抜くステップを含む。所定の時間の後、力が医療用流体カセットに加えられ、医療用流体カセットの第2の圧力を測定する。第1の圧力と第2の圧力の測定の比較に基づいて、医療用流体カセットの可撓性膜に漏れが存在するか判定することができる。この方法は、加えられた力を複数回の圧力測定の間は医療用流体カセットから抜くため、いくつかの従来の漏れ検出方法よりも有利である。特に、医療用流体ポンピングマシン(例えば、PDサイクラー)のピストンを使用して力が医療用流体カセットに加えられ、医療用流体カセットの膜においてポンプチャンバの近傍、特にポンプチャンバの中央に漏れが位置する場合、ピストン自体が漏れを塞ぎ、連続的に加えられる力を用いて行われる試験間の膜の完全性に誤った信頼性が与えられる。圧力測定間は(例えば、ピストンを後退させることにより)加えられた力を取り除くことによって、加えられる力近傍での膜の漏れが塞がれず、(例えば、ポンプチャンバの上を覆う膜における)加えられた力近傍での漏れの検出が可能となるため、検出測定の精度が向上する。
PD流体カセット112は上述のようにして、例えば、通常使用と同じように、PDサイクラー102内に配置される。その後、ドア108を閉じ、掛け金をかける(ステップ200)。
いくつかの実施態様では、PD流体カセット112内の漏れを検出する最小体積法は、正確かつ信頼性が高い漏れ検出を提供しながらも簡略化することが可能である。例えば、システム真空作動前に行われるステップ412(カセット中に空気を再分配するために膨張可能パッド135を収縮させる)およびシステム真空作動後に行われるステップ418〜ステップ420(力の再印加および第2の圧力測定の準備のためにシステム真空を換気し、膨張可能パッド135を膨張させる)は省略できる。そうすることによって、本方法を実行する全体の所要時間を短くすることができる。加えて、特にピストンヘッド領域における漏れを検出するために非流路領域にはアクセスしないこの「簡略化された最小体積試験」をまず実行し、特に非流路領域における漏れを検出するために最小体積試験等の別の試験を実行して、限界3に対する126mbar(12.6kPa)の値を顕著に小さくできる。いくつかの実施態様では、2種類以上の試験を実行することによって、どの試験結果により漏れの検出が得られるかに基づいて漏れの大まかな位置(例えば、流路領域内または流路領域内)を特定することが可能になり得る。
上述の特定のPDサイクラーはタッチスクリーンおよび関連するボタンを備えるものとして説明されたが、PDサイクラーは、他の種類のスクリーンおよびユーザデータ入力システムを備えることができる。ある種の実施態様では、例えばサイクラーは、ディスプレイスクリーンに隣接するコンソールに配置されたボタン(例えば、フェザータッチボタン)を有するディスプレイスクリーンを備える。特定のボタンは、使用者が操作オプションと並んだボタンを押して所望の操作オプションを選択することができるように、使用中にスクリーンに表示される操作オプションと並んで配置され得る。種々のディスプレイスクリーンおよび特定のスクリーン、あるいは種々のディスプレイスクリーンまたは特定のスクリーンに表示される種々のアイテムを通して使用者が操作できるように、矢印ボタンの形態の追加のボタンがさらに提供され得る。その他のボタンは、使用者が、例えば操作パラメータを入力するために数値を入力できるように、テンキーの形態であることができる。使用者が矢印キーを使用して操作可能な操作オプションを選択できるように、および使用者がテンキーを使用して入力される値を入力できるように、あるいは使用者が矢印キーを使用して操作可能な操作オプションを選択できるように、または使用者がテンキーを使用して入力される値を入力できるように、選択または入力ボタンがさらに提供され得る。
Claims (30)
- 使い捨て医療用流体カセットの漏れを検出する方法であって、前記医療用流体カセットは、基部および可撓性膜が協働して少なくとも部分的に流体通路を形成するように、前記基部および前記基部に取り付けられる前記可撓性膜を備え、該方法は、
第1の力を前記可撓性膜に加えるステップと、
前記第1の力が前記可撓性膜に加えられている間、前記医療用流体カセットおよび医療用流体ポンピングマシンを備えるシステムの第1の物理的性質を測定するステップと、
前記可撓性膜から前記第1の力を取り除くステップと、
第2の力を前記可撓性膜に加えるステップと、
前記第2の力が前記可撓性膜に加えられている間、前記医療用流体カセットおよび前記医療用流体ポンピングマシンを備える前記システムの第2の物理的性質を測定するステップと、
前記第1の物理的性質と前記第2の物理的性質との比較に基づいて前記医療用流体カセットが漏れているか判定するステップと
を備える方法。 - 前記第1の物理的性質は前記医療用流体カセット内の第1の圧力を含み、前記第2の物理的性質は前記医療用流体カセット内の第2の圧力を含む、請求項1に記載の方法。
- 前記第2の圧力が前記第1の圧力より大きく、
前記第2の圧力と前記第1の圧力との差が所定の差分値以上である場合、前記医療用流体カセットが漏れを有すると判定される、請求項2に記載の方法。 - 前記第2の圧力が前記第1の圧力より小さく、
前記第1の圧力と前記第2の圧力との差が所定の差分値以上である場合、前記医療用流体カセットが漏れを有すると判定される、請求項2に記載の方法。 - 前記医療用流体ポンピングマシンは前記可撓性膜に向かって進められ前記可撓性膜から後退されるように構成されるピストンを備え、
前記第1の力を前記可撓性膜に加えるステップは、前記医療用流体カセットにおいて所定の圧力が得られるまで前記ピストンを前記可撓性膜に向かって進めることを含み、
前記第2の力を前記可撓性膜に加えるステップは、前記医療用流体カセットにおいて所定の圧力が得られるまで前記ピストンを前記可撓性膜に向かって進めることを含み、
前記第1の物理的性質は、前記第1の力を加える間、前記所定の圧力が得られているときの前記ピストンの位置に対応する前記ピストンの第1の位置を含み、
前記第2の物理的性質は、前記第2の力を加える間、前記所定の圧力が得られているときの前記ピストンの位置に対応する前記ピストンの第2の位置を含む、
請求項1〜4のいずれか一項に記載の方法。 - 前記第1の物理的性質と前記第2の物理的性質との比較は、前記第1の位置と前記第2の位置との差分を計算することを含む、請求項5に記載の方法。
- 前記第1の力は前記第2の力と同じである、請求項1〜6のいずれか一項に記載の方法。
- 前記医療用流体カセットは、前記流体通路と前記医療用流体カセットの外部との連通をもたらす流体入口ポートおよび流体出口ポートを備え、
前記第1の力を加えるステップは、前記流体入口ポートおよび前記流体出口ポートを開いて行われる、請求項1〜7のいずれか一項に記載の方法。 - 前記第1の力を前記可撓性膜から取り除く前に、前記流体入口ポートおよび前記流体出口ポートは閉鎖される、請求項8に記載の方法。
- 前記医療用流体カセットは、前記流体通路と前記医療用流体カセットの外部との連通をもたらす流体入口ポートおよび流体出口ポートを備え、前記第1の力を加えるステップは、前記流体入口ポートおよび前記流体出口ポートを閉じて行われる、請求項1〜9のいずれか一項に記載の方法。
- 前記第1の力を前記可撓性膜から取り除くステップから
前記第2の力を前記可撓性膜に加えるステップまでに、所定の時間経過させて待つステップをさらに含む、請求項1〜10のいずれか一項に記載の方法。 - 前記所定の時間は15秒から60秒の範囲である、請求項11に記載の方法。
- 前記医療用流体カセットは、前記流体通路と前記医療用流体カセットの外部との連通をもたらす流体入口ポートおよび流体出口ポートを備え、
前記第1の力を可撓性膜に加えるステップと前記システムの前記第1の物理的性質を測定するステップの間に、該方法は、流体が前記医療用流体カセット内に捕捉されるように前記流体入口ポートおよび前記流体出口ポートを閉鎖するステップを含む、請求項1〜12のいずれか一項に記載の方法。 - 該方法は、前記第1の力を前記可撓性膜から取り除くステップから前記第2の力を前記可撓性膜に加えるステップまでの間に、真空を前記可撓性膜の外側表面に加えるステップを含む、請求項13に記載の方法。
- 前記医療用流体カセットは、前記流体通路と前記医療用流体カセットの外部との連通をもたらす流体入口ポートおよび流体出口ポートを備え、
前記第1の力を前記可撓性膜に加えるステップの前に、該方法は、流体が前記医療用流体カセット内に捕捉されるように前記流体入口ポートおよび前記流体出口ポートを閉鎖するステップを含む、請求項1〜14のいずれか一項に記載の方法。 - 流体が前記医療用流体カセット内に捕捉されるように前記流体入口ポートおよび前記流体出口ポートを閉鎖するステップから前記第1の力を前記可撓性膜に加えるステップまでの間に、前記医療用流体カセット内の前記流体が再分配される、請求項15に記載の方法。
- 前記第1の力を前記可撓性膜に加えるステップは、前記可撓性膜の少なくとも一部が前記基部に接触するまで前記第1の力を加えるステップを含む、請求項1〜16のいずれか一項に記載の方法。
- 前記医療用流体ポンピングマシンはピストンを備え、
前記第1の力を前記可撓性膜に加えるステップは、前記可撓性膜と前記基部の間の空間が所定量を有するように前記ピストンを前記医療用流体カセットに向かって所定の位置まで進めることを含む、請求項1〜17のいずれか一項に記載の方法。 - 前記第2の力を前記可撓性膜に加えるステップは、前記ピストンを前記第1の物理的性質に対応する位置まで進めることを含む、請求項18に記載の方法。
- 前記方法は、前記第1の力を前記可撓性膜から取り除くステップから前記第2の力を前記可撓性膜に加えるステップまでの間に、真空を前記可撓性膜の外側表面に加えるステップを含む、請求項1〜19のいずれか一項に記載の方法。
- 使い捨て医療用流体カセットを収納するように構成された医療用流体ポンピングマシンであって、前記医療用流体カセットは、基部および可撓性膜が協働して少なくとも部分的に流体通路を形成するように、前記基部および前記基部に取り付けられる前記可撓性膜を備え、
前記医療用流体ポンピングマシンが、
前記医療用流体カセットを収納するコンパートメントと、
前記医療用流体カセットが前記コンパートメント内に配置されているときに前記医療用流体カセットに力を加えるように構成される圧力アプリケータと、
プロセッサであって、
前記医療用流体カセットが前記コンパートメント内に配置されているときに第1の力を前記可撓性膜に加えるように前記圧力アプリケータを制御し、
前記第1の力が前記可撓性膜に加えられている間、前記コンパートメント内に配置された前記医療用流体カセットを有する前記医療用流体ポンピングマシンを備えるシステムの第1の物理的性質を測定し、
前記医療用流体カセットが前記コンパートメント内に配置されているときに前記第1の力を前記可撓性膜から取り除くように前記圧力アプリケータを制御し、
前記医療用流体カセットが前記コンパートメント内に配置されているときに第2の力を前記可撓性膜に加えるように前記圧力アプリケータを制御し、
前記第2の力が前記可撓性膜に加えられている間、前記コンパートメント内に配置された前記医療用流体カセットを有する前記医療用流体ポンピングマシンを備える前記システムの第2の物理的性質を測定し、
前記第1の物理的性質と前記第2の物理的性質との比較に基づいて前記医療用流体カセットが漏れているか判定するように構成されている前記プロセッサとを備える、医療用流体ポンピングマシン。 - 前記プロセッサにより制御可能かつ前記医療用流体カセットが前記コンパートメント内にある間作動されたときに真空供給源が力を前記可撓性膜に加えることができるように前記コンパートメント内に配置される前記真空供給源を備え、
前記プロセッサは前記真空供給源を作動させることにより前記可撓性膜と前記基部との間隔を変えるように構成されている請求項21に記載の医療用流体ポンピングマシン。 - 前記プロセッサは、前記第1の力が前記可撓性膜から取り除かれるように前記圧力アプリケータを制御するステップから、前記第2の力が前記可撓性膜に加えられるように前記圧力アプリケータを制御するステップまでの間隔を変えるように構成されている、請求項22に記載の医療用流体ポンピングマシン。
- 前記真空供給源は前記可撓性膜の外側表面に力を加えることができる、請求項22または23に記載の医療用流体ポンピングマシン。
- 選択的に前記コンパートメントを閉鎖し、前記医療用流体カセットを前記コンパートメント内に保持するように構成されるドアと、
前記ドアの内部表面に配置され、前記医療用流体カセットが前記コンパートメント内にある間に膨張されると、膨張可能バッグが前記医療用流体カセットを圧縮するように構成され、
前記医療用流体カセットが前記コンパートメント内にある間に収縮されると、前記膨張可能バッグが前記ドアの内部表面に対して収縮し前記膨張可能バッグと前記医療用流体カセットとの間に空間を作るように構成される
ように構成される前記膨張可能バッグとを備え
前記プロセッサは、前記第1の力が前記可撓性膜から取り除かれるように前記圧力アプリケータを制御するステップから、前記第2の力が前記可撓性膜に加えられるように前記圧力アプリケータを制御するステップまでの間、前記ドアの前記膨張可能バッグを収縮させるように構成されている、請求項21〜24のいずれか一項に記載の医療用流体ポンピングマシン。 - 前記第1の力が前記可撓性膜に加えられるように前記圧力アプリケータを制御するステップは、前記可撓性膜が前記基部に対して圧縮されるように前記圧力アプリケータを制御することを含む、請求項21〜25のいずれか一項に記載の医療用流体ポンピングマシン。
- 前記圧力アプリケータは、前記コンパートメント内に進められ前記コンパートメントから後退されるように構成されるピストンを備える、請求項21〜26のいずれか一項に記載の医療用流体ポンピングマシン。
- 前記医療用流体カセットは、前記流体通路と前記医療用流体カセットの外部との連通をもたらす流体入口ポートおよび流体出口ポートを備え、
前記第1の力が前記可撓性膜に加えられるように前記圧力アプリケータを制御するステップは、前記流体入口ポートおよび前記流体出口ポートを開いて行われる、請求項21〜27のいずれか一項に記載の医療用流体ポンピングマシン。 - 前記医療用流体カセットは、前記流体通路と前記医療用流体カセットの外部との連通をもたらす流体入口ポートおよび流体出口ポートを備え、
前記プロセッサは、前記第1の力が前記可撓性膜に加えられるように前記圧力アプリケータを制御するステップから前記医療用流体カセット内の前記第1の圧力を測定するステップまでの間、前記流体入口ポートおよび前記流体出口ポートを閉鎖するように構成される、請求項21〜28のいずれか一項に記載の医療用流体ポンピングマシン。 - 前記医療用流体カセットは、前記流体通路と前記医療用流体カセットの外部との連通をもたらす流体入口ポートおよび流体出口ポートを備え、
前記第1の力が前記可撓性膜に加えられるように前記圧力アプリケータを制御するステップは、前記流体入口ポートおよび前記流体出口ポートを閉じて行われる、請求項21〜29のいずれか一項に記載の医療用流体ポンピングマシン。
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AU2014241932A1 (en) | 2015-07-02 |
US11262270B2 (en) | 2022-03-01 |
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AU2014241932B2 (en) | 2018-07-12 |
EP2968721A1 (en) | 2016-01-20 |
EP2968721B1 (en) | 2016-12-21 |
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CN105007960B (zh) | 2017-10-24 |
US20200191682A1 (en) | 2020-06-18 |
MX2015012574A (es) | 2016-01-12 |
US12061135B2 (en) | 2024-08-13 |
US20140276421A1 (en) | 2014-09-18 |
JP6419769B2 (ja) | 2018-11-07 |
US20220268661A1 (en) | 2022-08-25 |
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