JP2008531192A - 腹膜透析療法用ポータブル装置 - Google Patents
腹膜透析療法用ポータブル装置 Download PDFInfo
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Abstract
Description
血液透析では、患者の血液を人工腎臓透析機に通す。透析機の膜は血液を浄化するための人工腎臓としての役割を果たす。この治療は体外で行われるので、特殊な機械装置や、病院など治療を実施するセンターへの通院を必要とする。
合が良いとは限らない。多くの場合、PD装置に最適な場所は、患者とほぼ同じ高さにあり得るベッドに隣接するナイトテーブル上である。
図1を見ると、本発明のポータブルPD装置が示されている。ハウジング20は、患者が操作する制御ボタン26が付いたタッチスクリーン22を保持している。このカセットホルダは、ヒンジで取り付けられたドア24とカセット支持領域26とを有する。図4に示すカセット28は、このカセット支持領域26にぴったり収まる。後で説明するように、カセットを支持領域26に挿入し、カセットの上にドア24を閉めてラッチ固定する。
くラッチする。ドアは、容易に「カチッと」閉じるが、この閉じ方ではきちんと封止されない。カセット28を確実に基部30とドア24に密着封止するために、本発明のPD装置は、図3Aに示すインフレータブルパッド47を利用する。カセットを、それぞれ図3Aおよび2に示すプレート58とカセットエンクロージャ60との間の適切な位置に保持する。患者がドアを軽く閉めてラッチすると、システムはスイッチ42からその趣旨の信号を受信し、パッド47に空気がポンピングされ、すべての必要な封止が正しく行われるようにドア24と基部30をカセット(図4に示す)に押し付ける。少なくとも約2.758MPa(約400lb./sq.in)、好ましくは少なくとも約5.516MPa(800lb./sq.in)以上の真空圧を用いるが、通常、約2.758MPa(約400lb./sq.in)で十分である。これは、後で説明するように、正確な圧力検出には特に重要である。それにもかかわらず、患者はドアを閉めるのにドアまたはラッチに力を加える必要がない。
ポンプ44(図3Bで最も良く分る)はステッピングモータ45によって制御される。ステッピングモータ制御装置の詳細は後で説明する。本発明のPD装置は、同時および交互の2種のポンピングモードを使用する。交互法の場合、一方のポンプが突出している間、他方のポンプは引っ込んでいる。同時ポンピングでは、両方のポンプヘッドが同時に同方向に伸び、両方が同時に引っ込む。
ているポンプが引っ込むと、患者からの流体はチャンバB内に引き込まれる。この動作が完了すると、チャンバAに結合しているポンプは引っ込んで、患者から流体を汲み上げ、一方、ポンプBは突き出して、流体を排液ラインに移動させる。このプロセスは、所要量の患者からの流体が処理されるまで続く。
本発明のPD装置のエレクトロニクスボード101を図6に示す。本発明のPD装置の各ポンプを駆動するステッピングモータ100は、通常、ステッピングモータドライバ108に向け信号を送信するファームウエアを用いて制御する。ファームウエアは2つのフラッシュメモリ102および104内にある。フラッシュメモリ102内に格納されているファームウエアは、ブリッジフィールドプログラマブルゲートアレイ(FPGA)106のプログラミングに用いる。フラッシュメモリ104に格納されているファームウエアは、MPC823 PowerPC(登録商標)マイクロプロセッサ112のプログラミングに用いる。
図2を見ると、本発明の装置はさらに、当該技術では周知の空気圧システムを備えており、このシステムは、バルブを作動させ、インフレータブルパッド47を膨らませてドアを密閉するために液圧を供給する。対応リザーバへの空気または真空の供給にはコンプレッサーポンプ(図示せず)を用いる。連続ポンピングの間、この空気および真空源は、バルーンバルブ48を膨らませたり、しぼませたりするのに用いる。バルーンバルブは、膨らんでいるときには、流体が、選択されたバルーンバルブ48と係合するカセットのチャンネル1〜16(図4)の特定チャンネルを通って移動するのをブロックするであろう。バルーンバルブがしぼんでいるとき、流体は、そのバルーンバルブによって制御される特定チャンネルを通って自由に移動することができる。
図2および4を見ると、本発明のPD装置の極めて重要な要件は、流体リザーバと患者
との間の圧力の正確な測定と制御である。患者に連通する患者ラインへの圧力がアラームリミット上限を超えると、患者に深刻な被害が生じ得る。PDシステム自体はこのリミット上限をはるかに超える圧力で動作する必要がある。このような高い圧力は、圧力センサ、バルーンバルブおよびカセットの他の機能を操作するのに必要である。したがって、このような圧力は、患者が受ける圧力から独立して維持する必要がある。このような高い圧力を患者に近づけないようにするためには適切かつ確実な封止およびバルビングの使用を必要とする。
Pstat=静液圧(+1メートル = +100ミリバール、−1メートル =
−100ミリバール)
Ppatmax = −100ミリバール
Pvac = 真空チャンバの目標真空度
Pvac = Ppatmax + Pstat。
差圧 = +100ミリバール;
Pvac = −100ミリバール + 100ミリバール = 0ミリバール。
差圧 = 0ミリバール;
Pvac = −100ミリバール + 0ミリバール = −100ミリバール。
差圧 = −100ミリバール;
Pvac = −100ミリバール + −100ミリバール = −200ミリバール。
1. 患者ラインが開放されている;
2. 患者ラインが閉鎖されている;または
3. 患者ラインが完全には開放されていないために、(例えば、患者がライン上に横たわっていることに起因する)好ましくない流れ抵抗が生じている。
1. ポンプBが規定長値に達するまで突出しているとき患者ラインが開いており、患者への圧力が増大してない;
2. 患者ラインが閉鎖しており、患者圧力が規定アラームリミット上限まで増大しているためにポンプが突出し得ない;
3. ポンプは突出して患者圧力が増大しているが、圧力が徐々に低下している。
使い捨て装置を通過する流体流れを図5A〜5Lに示す。本発明のPD機は、フラッシュ、プライミング、排液、注液、中断および貯留という6つの流体処理シーケンスを利用する。フラッシュシーケンスの目的は、(患者ラインを除く)すべてのラインおよびカセットから空気を除去することである。これは、フラッシュすべきラインに透析液をポンピングすることにより達成される。
図5Aは、ヒータバッグからの溶液が患者から空気を押し出すプライミングシーケンスと、ヒータバッグからの溶液が患者にポンピングされる注液シーケンスとを示している。図5Jは、溶液が患者から流出して排液ラインにポンピングされる排液シーケンスを示している。
図5D、5F、5Hおよび5Lは、患者が未だPD機に接続されている間に、溶液バッグの溶液がヒータバッグにポンピングされる貯留シーケンスを示している。
患者管理PD機の1つの重要な部分は、図7に示すユーザインターフェースである。従来の機械に係わる共通問題は、機械がいまどのモードで作動しているか、患者が分らなくなることである。本発明では、タッチスクリーンディスプレイが、一方はモード指示部80、他方は操作説明部82という少なくとも2つの部分を有する。
、患者のデータを表示する患者データモード90と、患者の過去の治療を表示する治療歴モード92とを含むが、それらには限定されない。
Claims (7)
- 患者に腹膜透析を実施するために腹膜透析機と患者との間で流体をポンピングする装置であって、
それぞれ、可変ストロークを有し、患者の腹膜と流体収容チャンバとの間で接続するように構成されている1対のダイヤフラムポンプと、
患者からの排液を受容するチャンバと患者にポンピングする流体を収容するチャンバとを含む流体収容チャンバと、
ポンプを双方向作動させるために各ダイヤフラムポンプに連結されているステッピングモータと、
ポンプを所定増分および所定速度で正確にストロークさせて、患者と装置との間で所定時間内に正確な量の流体を流すように各ポンプのピストンの可変ストロークを制御する、1対のポンプを直列方向または反対方向に作動させ得るデジタルステッピングモータ制御装置と、からなる装置。 - 患者に腹膜透析を実施するために腹膜透析機と患者との間で流体をポンピングする装置であって、
カセットエンクロージャを含むことと、
カセットエンクロージャは、
少なくとも部分的に柔軟であり、かつ所定の流路を有するカセットを受容して保持するように構成された2つの実質的に平らな表面と、カセットはこれら2つの表面と整列し、実質的に平らな表面の一方は固定され、他方はヒンジで固定表面に取り付けられているため、ヒンジで取り付けられた表面を閉じるとカセットは平らな表面と整列した状態で保持されることと、
ヒンジで取り付けられた表面を閉じたときに、間にカセットを挟んで整列かつ確実に係合した状態で2つの表面を互いに圧迫するために2つの表面と整列して配置されたインフレータブルパッドを含むクランプ機構と、クランプ機構は2つの表面とカセットとを密着係合状態に維持するべく液圧で膨らませることと、を含むことと、
からなる装置。 - クランプ機構はヒンジで取り付けられた表面内に位置する請求項2に記載の装置。
- モード指示部と操作説明部とを含むタッチスクリーンディスプレイを有する腹膜透析ユニットの操作方法であって、
モード指示部は、それぞれ透析機が作動可能な複数のモードのうちの1つを表示する複数のタッチセンサ式表示ボタンを有し、ディスプレイは、治療、診断およびデータモードを含めた3種以上の操作モードのうちのどのモードで透析機が作動しているかを絶えず患者に通知するのに用いられ、操作説明部は、1つのモード内で実施されている特定の操作の詳細を表示するように変化し、3種の操作モードそれぞれの表示ボタンは、透析機が作動している間、常に患者に見えており、操作モードは患者がスクリーン上の表示ボタンの1つにタッチして選択し、
表示ボタンの1つにタッチして、透析機が作動している現在の操作モードを選択し、選択されたモードの表示ボタンをモードの選択に応答して強調表示する工程と、
操作説明部において、3種の操作モードそれぞれの表示ボタンの表示を変えること、または選択されたモードの表示ボタンの強調表示を変えることなく、選択された操作モード内の透析機の操作に関する表示情報を表示する工程と、
別の表示ボタンを選択して透析機の操作モードを変えることによって、別の表示ボタンを強調表示すると同時に、先に選択した前の操作モードの表示ボタンの強調表示を元に戻す工程と、からなる方法。 - 腹膜透析機内の圧力を測定する装置であって、
透析機作動時に流体を収容する柔軟な流体収容エンクロージャを有する着脱可能カセットと、
透析機内の所定位置にカセットを固定する保持機構と、
エンクロージャ内の圧力のどのような変化をも検出するように、カセットが透析機内に保持されているとき流体収容エンクロージャに密着して装着されている圧力センサと、
圧力センサで検出された圧力の変化に応じて透析機の操作を変更可能であるように、圧力センサと透析機の電子制御装置とを連結する部分と、からなる装置。 - 腹膜透析を受けている患者との間で流体をやりとりするための使い捨てカセットであって、
流体を収容するように構成された柔軟なエンクロージャと、
柔軟なエンクロージャから患者へ、また患者からエンクロージャへと流体を導くためにエンクロージャに接続された出入り通路と、
柔軟なエンクロージャは使い捨てカセットの外側に位置する表面を有することと、同表面は、エンクロージャ内に収容されている流体の圧力を測定するために圧力検出装置と係合するように構成されていることと、からなる使い捨てカセット。 - エンクロージャの表面は丸い請求項6に記載の使い捨てカセット。
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Also Published As
Publication number | Publication date |
---|---|
CA2599271A1 (en) | 2006-09-08 |
BRPI0609163A2 (pt) | 2010-02-23 |
EA200701834A1 (ru) | 2008-02-28 |
JP2010188164A (ja) | 2010-09-02 |
NZ560533A (en) | 2010-03-26 |
US20060195064A1 (en) | 2006-08-31 |
EP1855736A4 (en) | 2014-01-22 |
WO2006093620A2 (en) | 2006-09-08 |
JP5242626B2 (ja) | 2013-07-24 |
JP4777367B2 (ja) | 2011-09-21 |
IL185177A0 (en) | 2008-01-20 |
US20100222735A1 (en) | 2010-09-02 |
AU2006219068B2 (en) | 2011-09-08 |
CN101175514B (zh) | 2013-02-13 |
ZA200706923B (en) | 2008-09-25 |
WO2006093620A3 (en) | 2007-12-13 |
CN101175514A (zh) | 2008-05-07 |
KR20070107801A (ko) | 2007-11-07 |
AU2006219068A1 (en) | 2006-09-08 |
EA013511B1 (ru) | 2010-06-30 |
EP1855736A2 (en) | 2007-11-21 |
KR101254530B1 (ko) | 2013-04-19 |
IL185177A (en) | 2011-10-31 |
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