JP2010532234A - 供給容器自動接続を有する透析システム - Google Patents
供給容器自動接続を有する透析システム Download PDFInfo
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Abstract
Description
(Pl/Pl'−1)
この比率は、気体体積VgasをタンクVtankの既知の体積Vtankに加算して乗算されて、ポンプで送られた流体のリアルタイム体積Vfluid=(Pl/Pl'−1)(Vtank+Vgas)を生成する。Plは、最初は、Pl'に同等であるため、ポンプで送られた流体の初期リアルタイム体積は、ゼロに等しくなる。Pl'は、経時的にP1よりも徐々に小さくなるため、(Pl/Pl'−1)は、経時的に徐々に大きくなり、Vfluidも同様に大きくなる。
ここで、図面、具体的には図1から図3を参照すると、自動腹膜透析(APD)システム10等の透析システムが図示される。システム10が、上述のシステムのいずれか等の他の種類の腎不全療法システムと使用可能であることを理解されたい。
次に図4から図9を参照すると、透析システム10のバック管理システム30のある実施形態が示される。図示するように、バック管理システム30は、機器または循環器20に接続されるか、またはそれと一体的に作製される。図示するバック管理システム30は、4つの、例えば、6リットル供給バック40aから40d(本明細書において総称して供給バック40と呼ぶか、または概して、個別に供給バック40と呼ぶ)のために構成される。システム30は、代替として、より多いまたは少ない6リットルバック40を保持するように構成される。また、図4から図9は、循環器20が、ヒンジ付きディスプレイ24を含むことを示し、ヒンジ付きディスプレイ24は、別個の制御部22および/またはタッチスクリーンオーバーレイで動作することが可能である。
次に図10および図11を参照すると、システム10の使い捨てセット50のある実施形態が示される。図10は、使い捨てセット50が、使い捨てカセット28および上述の供給バック40を含むことを示す。ある実施形態におけるバック40の各々は、溶液ラインまたはピグテール46aから46d(本明細書において総称してピグテール46と呼ぶか、または概して、個別にピグテール46と呼ぶ)であって、第1の組48aの供給ラインに接続する溶液ラインまたはピグテール46aから46dを含む。一実施形態における溶液ラインまたはピグテール46は、先端保護具66aによって保護される雌型コネクタ56で終端となる。一実施形態におけるコネクタ56は、穿刺可能なカバーにより保護される雌型コネクタである。使い捨てセット50は、後述する大容量療法のための第2の組の供給ライン48bを含むことが可能である。第1および第2の供給ライン組の各々は、先端保護具66bにより保護されるコネクタ58で終端となる複数のラインを含む。コネクタ58は、バックライン46の雌型コネクタ56の保護カバーを通ってスパイクする雄型のスパイク状コネクタであることが可能である。
次に図12を参照すると、ある実施形態における機器20は、ピンチクランプまたはピンチ弁68aから68d(本明細書において総称して弁68と呼ぶか、または概して、個別に弁68と呼ぶ)を含み、供給バック40aから40dのそれぞれのピグテール46aから46d毎に、(または、4−1マニホールド60のマニホールドライン64のために)弁68が1つある。クランプ68aから68dは、(i)ピグテール46の端部におけるコネクタ56が、固定式コネクタホルダ70に取り付けられる場合、および(ii)各コネクタ56を保護する先端保護具66aが、自動接続機構の先端保護具取り外しキャリッジ72に最初に取り付けられる場合に、ピグテール46aから46dをそれぞれ保持および閉塞するために配置される。また、先端保護具取り外しキャリッジ72は、以下に示すように、スパイク状コネクタ58の先端保護具66bを取り外すようにも構成される。ピンチクランプまたは弁68は、流体が供給バック40から順に引き込み可能になるように、例えば、順に開放される。ある実施形態におけるクランプ68は、供給バック40の接続後にカセット28を再装填する必要がある場合に、自動的に閉鎖される。固定式ホルダ70は、供給バックのピグテールのコネクタ56を自動接続工程中に固定して保持する。
図14は、自動識別システムの一実施形態を示す。システムは、カラーキャプチャ素子(CCD)カメラ80を含み、カメラ80は、電荷結合素子画像センサおよびリンクコンデンサ、結合コンデンサ、または感光性コンデンサの配列を含む集積回路を使用する。図14に示す接続範囲の3次元画像を生成する他のカメラを、代替として使用し得る。自動識別システムは、カメラ80からの画像を使用して、溶液バック40の特徴を判断し、かつ正確で無傷のコネクタ56および58が機構に装填されるかを検証する。
ある実施形態では、2重管腔型患者ライン52(図10)を使用する。一方の管腔は、使い捨てカセット28のポンプチャンバを介して、患者用排液ポートに接続される。他方の管腔は、使い捨てカセット28の異なるポンプチャンバを介して、患者用充填ポートに接続される。患者ラインのプライミング中、患者ラインの2つの管腔は、一緒に接続される。循環器20によって、カセット28の隔膜ポンプのうちの1つが、使い捨てカセット28上の患者用充填ポートから未使用の流体をポンプで送出するか押圧し、患者ラインの端部に到達するまで患者ライン52の管腔を下降する。次いで、未使用の流体は、患者用排液ポートを介してカセット28の別の隔膜ポンプまで、患者ライン52の他方の管腔を上昇して、カセット28に戻るようにポンプで送入され、これによって、患者ライン52を介して流体が押圧する空気が除去される。流体が第2のポンプチャンバを充填する場合に、患者ラインは完全にプライミングされている。
プライミング済み2重管腔型患者ライン(充填用管腔52aおよび排液用管腔52bが接続されている)および移送セット82(充填ライン84および排液ライン86が接続される)は、図15Aから図15Eに示す患者ライン自動接続デバイス90に装填される。デバイス90は、機器20から分離可能であるか、または機器20に一体化可能である。ある実施形態における機器20またはカート12は、デバイス90を保管する範囲および装置を提供する。デバイス90は、手動操作または手動/自動操作のために電力供給されるかまたは構成されることが可能である。デバイス90は、固定部分92と、固定部分92に対して回転可能および並進可能な部分94とを含む。
患者の排液中、システム10は、2重管腔型患者ライン52の戻し管腔52bを介して、患者から廃液を除去する。排液が完了し、システム10が充填サイクルに進むと、システム10は、2重管腔型患者ライン52の充填管腔52aを介して未使用の流体を患者に送達する。ここで、患者に戻って「再循環」される廃液は、移送セット82の充填ライン82および患者のカテーテルにおける小量の廃液だけである。2重管腔型カテーテルおよび移送セットを使用する場合、この量ですら、患者に再循環される必要はない。さらに、2重管腔型カテーテルおよび2重管腔型移送セットをシステム10と使用する場合、システム10は、多重経路連続流腹膜透析(CFPD)療法を実行することが可能である。多重経路CFPD療法は、長い再循環流滞留を伴う単一充填を用いることが可能であるか、またはCFPD療法は、タイダルの類であって、滞留時間のうちの少なくとも1つの時間中に流れを再循環することが可能である。
次に図16を参照すると、カセット100は、カセットおよびそれを作製する方法に関する一実施形態を示し、カセット100において、カセットの硬質プラスチック部分110は、カセットシート102内に封入される。しかしながら、シート102は、剛体部分110の両側面に溶接されておらず、代わりに、シート102は、それ自体に溶接される。一実施形態におけるプラスチック部分110は、剛性であり、アクリロニトリルブタジエンスチレン(ABS)、アクリル、ポリオレフィン、ポリカーボネート、ポリエチレン、またはポリプロピレンから作製される。一実施形態におけるシート102は、例えば、液体をポンプで送るように湾曲し、かつ弁チャンバを開放および閉鎖するために可撓性である。シート102は、ポリ塩化ビニル(PVC)、ポリエチレン、クレイトン、またはポリオレフィンから作製可能である。また、2つ以上の積層の異なるまたは同じ材料を使用することが可能であり、この場合、積層の粒子は、相互に垂直に流動し、強度を増加させ、スリット、穴、および断裂の可能性を最小化することが可能である。例えば、カセットの各外側は、優れた摩耗、穿刺、および裂傷抵抗を有し、中央の層は、優れた強度特性を有することが可能である。
次に図19から図22を参照すると、空気圧システム150は、本開示の使い捨てカセットポンプインターフェースの一実施形態を示す。システム150は、使い捨てカセット140を含む。使い捨てカセット140は、上述のカセット100および130と類似し、同一の番号を有する多くの同一構成要素を含む。カセット140は、剛体ハウジングまたは部分110を含む。可撓性シート104aおよび104b(図19には図示されない)は、剛体部分110に溶接または接着される。代替として、シート104aおよび104bは、カセット100に関連して上述したように、単一の折り畳まれたシート102から形成される。カセット140は、カセット100について図16に示した側の裏側から示される。本図面において、ポンプチャンバ112aおよび112bは、外側に膨張し、図16に示すポンプチャンバ112の裏側を示す。カセット140は、代替として、カセット130に関連して上述したように、第3のポンプチャンバ112cを含むことが可能である。
次に図27を参照すると、システム250は、本明細書に説明する透析システム10の空気圧式制御に関する一実施形態を示す。システム250の上部は、図19から図24、図25A、図25B、図26Aおよび図26Bに関連して上述した構成要素を表す。LP、LS、LH、LF、LD、RP、RS、RH、RF、RDは、膜ガスケットの弁ウェルおよび使い捨てカセットの弁チャンバを表す。10個の弁について本図面および図19から図24、図25A、図25B、図26Aおよび図26Bにおいて説明しているが、混合に対応するか否か、またはインラインもしくはバッチ加熱を使用するか否かに関わらず、供給バック能力等の多くの要因に基づいて設けられる弁の数は増減し得る。
式中、Pref,finalは、薬液ポンプが体積参照チャンバ(例えば、VSL)を加圧可能になった後の、体積参照チャンバ(例えば、VSL)における最終圧力であり、本例では2.4psig。
次いで、図28Bおよび図28Cの測定時間の間にポンプで送られた体積は、移動した流体Vfluid=空のチャンバの空気体積Vgas,empty−充填したチャンバの空気体積Vgas,fullであり、これは、24.75ミリリットル−8.6ミリリットル=16.15ミリリットルになる。
デキストロースでは、(20ミリリットル+1.2ミリリットル)/2−1.2=9.4ミリリットル、
重炭酸塩では、(20ミリリットル+1.2ミリリットル)/2−0=10.6ミリリットル、
であるように計算される。標的組のポンプストローク体積は、最大20ミリリットルまで増加し、累積デキストロース体積が重炭酸塩の累積体積と同等になるように、デキストロースの累積体積を補正する。
次に図32および図33を参照すると、システム500は、システム10の1つの可能な流体温度測定装置および方法を示す。温度測定システム500は、非侵襲性であるため有利である。システム500は、使い捨てセット50の一部分を流動する流体の温度を測定する。例えば、システム500は、使い捨てカセット28、100、130、140を流動する流体、例えば、インライン加熱とともに使用するカセットの流体加熱通路の上流、下流、またはその通路に直接の流体の温度を測定し得る。または、流体は、流体加熱器の上流および/または下流に直接等の、流体ラインのうちの1つを流動する間に検知され得る。さらに代替として、流体は、バッチ加熱とともに使用する温かいバック等の、バックまたは容器内に存在する間に検知され得る。
TCALC=1.047*TRTD−0.0303
であることが分かる。
次に図35および図36を参照すると、誘導的検知システム530は、(i)単一チャンバ供給バック40(概して、上述の供給バック40aから40dを言及する)または多重チャンバ供給バック540が、棚32、34、36、および38のうちの特定の棚上に存在するか否か、および(ii)供給バックが多重チャンバ供給バック540であれば、関連の壊れ易い密封部542が破壊されて、別々のチャンバ546aおよび546bからの2つ以上の濃縮液544aおよび544bがそれぞれ混合可能であるか否かを検出するための一実施形態を示す。
Claims (20)
- 少なくとも1つのポンプアクチュエータを含む透析機器と、
該少なくとも1つのポンプアクチュエータと動作可能である使い捨てカセットであって、複数の供給ラインが、該使い捨てカセットに接続され、各供給ラインは、供給ラインコネクタおよび供給ライン先端保護具を含む、使い捨てカセットと、
複数の透析液容器であって、該透析液容器の各々は、溶液ラインコネクタおよび溶液ライン先端保護具を有する溶液ラインを含む、複数の透析液容器と、
自動接続機構であって、
溶液ラインコネクタホルダと供給ラインコネクタホルダであって、該ホルダのうちの一方は固定され、該ホルダのうちの他方は可動である溶液ラインコネクタホルダと供給ラインコネクタホルダ、および
可動先端保護具取り外し部
を含む、自動接続機構と
を備える、透析システム。 - 前記先端保護具取り外し部は、前記溶液ラインコネクタおよび前記供給ラインコネクタの両方から先端保護具を取り外すために、前記溶液ラインコネクタホルダと前記供給ラインコネクタホルダとの間で並進可能である、請求項1に記載の透析システム。
- 前記先端保護具取り外し部は、前記溶液ラインおよび供給ラインの先端保護具のうちの一方を保持するように構成され、該先端保護具の他方は、該先端保護具取り外し部により保持される該先端保護具による取り外しのために保持されるように構成される、請求項1に記載の透析システム。
- 前記先端保護具取り外し部は、前記溶液ラインの先端保護具を把持および保持するように構成され、該溶液ラインの先端保護具は、前記供給ラインの先端保護具を把持および保持するように構成される、請求項3に記載の透析システム。
- 前記先端保護具取り外し部は、前記溶液ラインコネクタホルダに向かって第1の方向に並進可能であり、前記供給ラインコネクタホルダに向かって第2の方向に並進可能である、請求項1に記載の透析システム。
- 前記先端保護具取り外し部は、前記溶液ラインコネクタホルダと前記供給ラインコネクタホルダとの間の経路から離れるように並進可能であり、これによって、該コネクタホルダが嵌合可能になる、請求項1に記載の透析システム。
- 前記溶液ラインコネクタホルダは固定され、前記供給ラインコネクタホルダは、該溶液ラインコネクタホルダに対して並進可能である、請求項1に記載の透析システム。
- 前記溶液ラインコネクタまたは供給ラインコネクタからの先端保護具の取り外し前に閉鎖するドアと、該ドアの後方から露出したコネクタを飽和するように配置される超純空気源とを含む、請求項1に記載の透析システム。
- 前記溶液ラインおよび前記供給ラインのうちの少なくとも1つを閉鎖するように配置されるピンチクランプを含む、請求項1に記載の透析システム。
- 前記溶液ラインコネクタおよび前記供給ラインコネクタのうちの少なくとも1つは、編成具に保持され、該編成具によって、該コネクタは、前記溶液ラインコネクタホルダまたは前記供給ラインコネクタホルダに一度に装填可能になる、請求項1に記載の透析システム。
- 前記自動接続機構は、機器制御部とともに、前記透析機器の正面に位置する、請求項1に記載の透析システム。
- 前記溶液ラインコネクタが前記溶液ラインコネクタホルダに装填される際に、該溶液ラインコネクタのうちの少なくとも1つに配置された情報を読み取るように位置決めされるカメラを含む、請求項1に記載の透析システム。
- 前記情報は、前記透析液容器のうちの1つにおける溶液の種類および体積のうちの少なくとも1つを標示する、請求項12に記載の透析システム。
- 少なくとも1つのポンプアクチュエータを含む透析機器と、
該透析機器上に配置される第1の組のラインおよび第1のライン組ホルダと、
該透析機器上に配置される第2の組のラインおよび第2のライン組ホルダと、
該透析機器上に配置される先端保護具取り外し部と、
少なくとも1つのプロセッサであって、
(i)該先端保護具取り外し部に、該第1の組のラインおよび該第2の組のラインから先端保護具を取り外させ、
(ii)該先端保護具取り外し部に、該第1のライン組ホルダと該第2のライン組ホルダとの間の経路から離れるように移動させ、
(iii)該第1のライン組ホルダおよび該第2のライン組ホルダに、該第1の組のラインおよび該第2の組のラインを接続するように該通路に沿って移動させる
ように構成される少なくとも1つのプロセッサと
を備える、透析システム。 - 前記少なくとも1つのプロセッサは、前記先端保護具取り外し部および前記ライン組ホルダのうちの少なくとも1つを取り外すために、複数のステッピングモータと動作可能である、請求項14に記載の透析システム。
- 前記第1のライン組ホルダおよび前記第2のライン組ホルダは、前記第1の組のラインの端部および前記第2の組のラインの端部においてコネクタを保持するように構成される、請求項14に記載の透析システム。
- 前記プロセッサは、前記先端保護具取り外し部に、前記先端保護具の取り外しを容易にするために前記機器から離れるように延びさせるようにさらに構成される、請求項14に記載の透析システム。
- 前記プロセッサは、前記先端保護具取り外し部に、前記第1のライン組ホルダおよび前記第2のライン組ホルダから前記組のラインを取り外す前に、該組のラインに前記先端保護具を再接続させるようにさらに構成される、請求項14に記載の透析システム。
- 使い捨てカセットと、
該使い捨てカセットに接続される複数の供給ラインと、
各供給ラインの端部に位置する供給コネクタと、
複数の透析液容器と、
各透析液容器に接続される溶液ラインと、
各溶液ラインの端部に位置する溶液コネクタと、
供給コネクタホルダと、
溶液コネクタホルダと、
先端保護具取り外し部と、
複数のモータと
を備え、
該ホルダ、先端保護具取り外し部、およびモータは、(i)該ホルダのうちの少なくとも1つに向かって該先端保護具取り外し部を移動させ、(ii)互に向かいおよび互に離れるように該ホルダを移動させるように構成および配置される、
透析システム。 - 少なくとも1つのポンプアクチュエータを有する透析機器をさらに含み、前記ホルダおよび先端保護具取り外し部は、該透析機器に接続される、請求項19に記載の透析システム。
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US11/773,750 US7736328B2 (en) | 2007-07-05 | 2007-07-05 | Dialysis system having supply container autoconnection |
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PCT/US2008/068908 WO2009006471A2 (en) | 2007-07-05 | 2008-07-01 | Dialysis system having supply container autoconnection |
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US20120089085A1 (en) | 2012-04-12 |
JP5396383B2 (ja) | 2014-01-22 |
US20140027380A1 (en) | 2014-01-30 |
JP6246275B2 (ja) | 2017-12-13 |
JP5973611B2 (ja) | 2016-08-23 |
US20220211926A1 (en) | 2022-07-07 |
US11311657B2 (en) | 2022-04-26 |
US8257299B2 (en) | 2012-09-04 |
JP2016195812A (ja) | 2016-11-24 |
JP2013144145A (ja) | 2013-07-25 |
MX348969B (es) | 2017-07-05 |
US20100229366A1 (en) | 2010-09-16 |
US11931497B2 (en) | 2024-03-19 |
US8083709B2 (en) | 2011-12-27 |
US20090012455A1 (en) | 2009-01-08 |
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US20190298906A1 (en) | 2019-10-03 |
US20120067805A1 (en) | 2012-03-22 |
WO2009006471A3 (en) | 2009-05-22 |
WO2009006471A2 (en) | 2009-01-08 |
JP6860133B2 (ja) | 2021-04-14 |
MX2010000287A (es) | 2010-04-27 |
JP2018047270A (ja) | 2018-03-29 |
US7736328B2 (en) | 2010-06-15 |
EP2167160A2 (en) | 2010-03-31 |
JP5726938B2 (ja) | 2015-06-03 |
JP2015144858A (ja) | 2015-08-13 |
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US10335532B2 (en) | 2019-07-02 |
MX2020011138A (es) | 2021-02-09 |
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