JP2015097901A - 血液透析システム - Google Patents
血液透析システム Download PDFInfo
- Publication number
- JP2015097901A JP2015097901A JP2015040184A JP2015040184A JP2015097901A JP 2015097901 A JP2015097901 A JP 2015097901A JP 2015040184 A JP2015040184 A JP 2015040184A JP 2015040184 A JP2015040184 A JP 2015040184A JP 2015097901 A JP2015097901 A JP 2015097901A
- Authority
- JP
- Japan
- Prior art keywords
- dialysate
- cassette
- fluid
- pump
- blood
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
- A61M1/156—Constructional details of the cassette, e.g. specific details on material or shape
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- A—HUMAN NECESSITIES
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- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
- A61M1/153—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit the cassette being adapted for heating or cooling the treating fluid, e.g. the dialysate or the treating gas
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
- A61M1/154—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit with sensing means or components thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
- A61M1/155—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit with treatment-fluid pumping means or components thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
- A61M1/156—Constructional details of the cassette, e.g. specific details on material or shape
- A61M1/1562—Details of incorporated reservoirs
- A61M1/15625—Details of incorporated reservoirs the reservoirs acting as balance chambers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
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Abstract
【解決手段】透析装置を通じて透析液供給体から透析液が通過して流れる透析液流路を含むカセットシステムと、これとは別体の血流路とを備える血液透析システム。透析液流路は、1つのカセットアセンブリに組み合わされた平衡流体回路、混合流体回路、及び配向流体回路を含み、平衡流体回路が第1のカセットにより、混合流体回路が、第2のカセットにより、配向流体回路が、第3のカセットにより形成され、血流路において、血液は内部に患者からくみ出されるとともに透析装置内を通過する。
【選択図】 図1
Description
図36A乃至36Eに、底部プレート1100を示す。図36A及び36Bに、底部プレート1100の内側表面を示す。内側表面は図34Eに示すミッドプレート(ここには図示しない)の底面に接触する側である。底部プレート1100はエアライン(図示しない)に取り付けられる。図34Eに示すポッドポンプ820,928及び弁(ここには図示しない)を駆動させる空気のための対応する入口の穴1106はミッドプレートに設けられる。穴1108,1110は図34Cに示す、第2の流体入口824、及び第2の流体出口826にそれぞれ対応する。流路のための溝1112のように、ポッドポンプ820,828及び平衡ポッド812,822の対応する半分を更に示す。頂部プレートとは異なり、ポッドポンプ820,828及び平衡ポッド812,822に対応する底部プレートの半分はポッドポンプ820,828及び平衡ポッド812、822間の違いを明瞭にする。ポッドポンプ820,828は底部プレートに第2の半分に空気の通路を備え、平衡ポッド812,822は頂部プレートで半分と同一の構造を備える。更に、平衡ポッド812,822は流体の平衡を保持し、これにより図示しない隔壁の両側は液体の流路を含み、ポッドポンプ820,828は液体をくみ出す圧力ポンプであり、これにより一方の側は液体流路を含み、底部プレート1100に示す他方の側は空気駆動のチャンバ又は空気流体路を含む。
powerHeater=massFlow*((tankPGain*errorTank)+(UFPGain*errorUF)
PowerHeater=ヒータの使用率命令(0乃至100%);
MassFlow=流体質量流速度;
TankPGain=タンク又は入口の温度センサのための比例ゲイン;
ErrorTank=タンク又は入口の温度センサ及び望ましい温度の間の差異;
UFPGain=限外濾過膜又は出口の温度センサのための比例ゲイン;
ErrorUF=uf又は出口の温度センサ及び望ましい温度の間の差異。
透析液は更に例えば限外濾過膜を使用して汚染物、感染性の生物、病原体、発熱物質、残骸等を取除くべく濾過される。フィルタは図3Aに示すように配向回路と平衡回路の間にて、透析液流路の好適な位置に配置され、且つ/又は限外濾過膜は配向回路か平衡回路に組み込まれる。限外濾過膜が使用される場合に、フィルタを通して上記タイプを防止する網寸法を有すべく選択される。例えば、網寸法は約0.3マイクロメートル以下、約0.2マイクロメートル以下、約0.1マイクロメートル以下、或いは約0.05マイクロメートル以下等である。当業者は限外濾過膜のようなフィルタは、多くの場合、市場にて容易に入手可能であることを認識するだろう。
上述したように、図11Aの空気の駆動システム110の正の供給弁117、及び負の供給弁118は二通りのオンオフ弁に対して好適に可変的な制限弁である。可変的な弁の使用によって、駆動チャンバ112及び隔壁109に作用される圧力は、隔壁に完全なタンク圧力を作用させることに代えてタンク121,122の僅かな圧力により容易に制御することができる。従ってポッドポンプを駆動させるための圧力がポッドポンプにより異なっても、異なるポッドポンプに対して、同じタンクやタンクの組が使用可能である。タンク圧力は様々なポッドポンプの隔壁に作用される好適な圧力と比較してより大きい必要があるが、1つのポッドポンプは半分のタンク圧力により駆動され、別のポッドポンプは同じタンクにより駆動されるが、四分の一のタンク圧力により駆動する。従って、透析システムの別のポッドが異なった圧力にて駆動するように設計されても、これらのポッドポンプは全て同じタンクか同じ組のタンクを共有するが、様々な弁を使用して異なった圧力にて駆動される。ポッドポンプにて使用される圧力は透析の工程において生じるか、或いは変化する状況に応じて変化する。例えば管が歪むことによりシステムの管が圧縮された場合に、ポッドポンプにおいて使用される正又は負の圧力、或いはその両者が制限の上昇を補うために高められる。
「冷たい」セクションの内である部品の例をとしては、電源、電子工学部品、送電線、空気制御部品、等が挙げられる。実施例において、「熱い」セクションに出入する流体の少なくとも数種は「冷たい」セクション内を通過する。但し、他の実施例では、流体は「冷たい」セクションを通らないで「熱い」セクションのみを通過する。
部品を「熱い」セクションと、「冷たい」セクションとに分けることには複数の利点がある。電装品の使用寿命、信頼性、又は使用効率が挙げられる。例えば、部品を「熱い」セクションと「冷たい」セクションに分けることによって、ホットボックス全体が加熱される。これにより、より優れたエネルギー有効システムを実現するために熱が有効的に使用される。これは熱のよりエネルギー効率が良いシステムをもたらすより有効な使用を可能にする。これはまた低価格に実現すための標準的な、在庫中の電子部品の使用を可能にする。
図57においてコネクタ4401が基盤4301に示される。頂部プレート4302はコネクタ4303と共に示されている。センサプローブ4501は流路4503に頂部プレート4302を介して伸びる。センサプローブ4501は本明細書中でも述べたセンサプローブを含む様々な形状のセンサである。
一連の実施例において、停電時には、可能な限り多くの血液を患者に戻すことが好ましい。血液透析システムの一実施例では、使用される様々なポンプや弁を駆動させるために圧縮された気体を使用するため、他の実施例では、このような圧縮された気体を利用して、停電時にシステムの血液を患者へ戻すことができる。この方法に従うと共に、図29Aを参照して、透析装置14を横切って透析液を注入して、血流回路19内の血液を浄化して患者に戻す。圧縮空気を使用して透析液を透析装置14内へ注入する。弁77が圧縮空気を解放するとこの機能を始動する。この方法は、停電や他の障害によって、透析装置が処置の終わりに通常行う方法で患者の血液を浄化して戻すことが妨げられた場合に、使用することが可能である。
これらの実施例の何れかにおいて、システムの操作又は方法は、処置の合間に透析液装置のプログラムを実行することによって、周期的に検査される。検査中は、ユーザ・インタフェースによって、使用者は浄化−戻し処置を実行するように促され、装置は、操作が正常に行われるように、透析液回路の圧力を監視する。
システム及び方法の一実施例の実施は、図29Aに示されており、使用される材料の親水性を利用して透析装置14内に細い管を形成する。この材料が湿潤していると、透析液は通過できるが、空気は通過できない。図29Aに示す実施例を実行する場合には、空気は透析装置14に進入できるが、血流回路10を越えて通過しない。
Methods);2007年4月13日に出願された米国特許出願第11/787,213号、発明の名称「熱交換システム、装置及び方法(Heat Exchange Systems,Devices and Methods)」;2007年4月13日に出願された米国特許出願第11/787,212号、発明の名称「流体ポンプシステム、装置及び方法(Fluid Pumping Sytems,Devices and
Methods)」;2007年4月13日に出願された米国特許出願第11/787,112号、発明の名称「熱及び伝導度感知システム、装置及び方法(Thermal and Conductivity Sensing Systems,Devices
and Methods)」;2007年10月12日に出願された米国特許出願第11/871,680号、発明の名称「ポンプカセット(Pumping Cassette)」;2007年10月12日に出願された米国特許出願第11/871,712号、発明の名称「ポンプカセット(Pumping Cassette)」;2007年10月12日に出願された米国特許出願第11/871,787号、発明の名称「ポンプカセット(Pumping Cassette)」;2007年10月12日に出願された米国特許出願第11/871,793号、発明の名称「ポンプカセット(Pumping Cassette)」;及び2007年10月12日に出願された米国特許出願第11/871,803号、発明の名称「カセットシステム統合装置(Cassette System Integrated Apparatus)」。更に、以下は、全体を参照によって本明細書に組み込まれるものである:1989年2月28日に特許付与された米国特許第4,808,161号、発明の名称「圧力測定フロー制御システム(Pressure−Measurement Flow Control System)」;1989年5月2日に特許付与された米国特許第4,826,482号、発明の名称「強化された圧力測定フロー制御システム(Enhanced Pressure−Measurement Flow Control System)」;1990年12月11日に特許付与された米国特許第4,976,162号、発明の名称「強化された圧力測定フロー制御システム(Enhanced Pressure−Measurement Flow Control System)」;1992年2月18日に特許付与された米国特許第5,088,515号、発明の名称「取り外し可能な流体インターフェースを備えた弁システム(Valve System with Removable Fluid Interface)」;1994年9月27日に特許付与された米国特許第5,350,357号、発明の名称「重力流に逆らう流体の配分及びポンプカセットを用いる腹膜透析システム(Peritoneal Dialysis Systems Employing a Liquid Distribution and Pumping Cassette that Emulates Gravity Flow)」。更に、全体を参照によって本明細書に組み込まれるものは、本願と同日付けで出願された米国特許出願、発明の名称「センサ装置システム、デバイス及び方法(Sensor Apparatus Systems, Devices and Methods)」(整理番号F63、米国特許出願第12/038,474号)、及び本願と同日付けで出願された米国特許出願、発明の名称「カセットシステム統合装置(Cassette System
Integrated Apparatus)」(整理番号F62)である。
but not both)」を示すと解釈されるべきである。請求項において使用される場合、「実質上〜を含む(consisting essentially of)」は、特許法の分野において使用されるような通常の意味を有する。
least one of A or B)」や、同等に「A及び/又はBの少なくとも1つ(at least one of A and/or B)」)は、一実施例において、少なくとも1つとは、1つ以上、Aを含み、Bは存在しない(及び任意でB以外の要素を含む)ことを示し;他の実施例において、少なくとも1つとは、任意で1つ以上、Bを含み、Aは存在しない(及び任意でA以外の要素を含む)ことを示し;更に他の実施例において、少なくとも1つとは、1つ以上、Aを含み、及び少なくとも1つ、任意で1つ以上、Bを含む(及び任意で他の要素を含む)こと;等を示す。
Claims (15)
- 血流回路(10)と、流体平衡または内側透析液回路(143)と、流体配向または外側透析液回路(142)と、透析液混合回路(25)とを備える血液透析システムであって、
前記血流回路は、透析装置を通じて血液をくみ出すための2つの隔壁ポンプ(13)を有する血流カセット(22)を含み、該流体平衡回路は、2つ以上の隔壁ポンプ(161,162)、2つ以上の流体平衡チャンバ(342,342;706,708)、および前記透析装置を通じて前記血液からの流体を透析液と交換するための限外濾過ポンプ(35)を含む平衡カセット(700)を含み、前記流体配向回路は、前記平衡カセットに透析液をくみ出すための2つ以上の隔壁ポンプ(159,602/604)を含む配向カセット(600)を含み、前記透析液混合回路は、透析液を混合するとともに透析液容器(1502)に透析液を送るための2つ以上の隔壁ポンプ、混合チャンバ(189; 504)、および2つ以上の定量ポンプ(183,184; 8030,8032)含み、
前記混合カセット、平衡カセット、および配向カセットは、一体的カセットアセンブリ内へと剛性を備えた流体導管によって相互に連通するとともに連結されることを特徴とする血液透析システム。 - 前記システムは、水を重炭酸と混合して重炭酸混合物を形成し、酸性溶液を前記重炭酸混合物と混合して透析液を形成し、かつ前記透析液を前記透析液容器に送るべく前記混合カセットを制御するように構成されることを特徴とする請求項1に記載の血液透析システム。
- 前記システムは、前記透析液容器から透析液を受承するとともに前記平衡カセットに前記透析液を送るべく前記流体配向カセットを制御するように構成されることを特徴とする請求項1または2に記載の血液透析システム。
- 前記システムは、前記平衡カセットに先だってヒータ(1506)に透析液を送るべく前記流体配向カセットを制御するように構成されることを特徴とする請求項3に記載の血液透析システム。
- 前記システムは、前記平衡カセットに先だって限外濾過装置(1508)に前記透析液を送るべく前記流体配向カセットを制御するように構成されることを特徴とする請求項4に記載の血液透析システム。
- 前記システムは、新鮮な透析液が透析装置に送られると、使用済みの透析液を前記新鮮な透析液と交換するべく前記平衡カセットを制御するとともに、前記透析装置を通じて前記血流カセットによってくみ出される前記血液から流体を抽出するべく限外濾過ポンプを制御するように構成されることを特徴とする請求項1乃至5のうちのいずれか一項に記載の血液透析システム。
- 前記システムは、前記混合カセットと連通する導電性カセット(1504)をさらに備え、前記導電性カセットは、伝導性センサおよび温度センサが位置される1つ以上の流体路を含み、前記システムは、重炭酸混合物を前記混合カセットから前記導電性カセットに送るとともに、前記混合カセットに戻すべく前記混合カセットを制御するように構成されるとともに、前記重炭酸混合物が前記導電性カセットにおける予め設定された閾値を満たす場合に、酸性溶液を前記重炭酸混合物と混合して透析液を形成するように構成されることを特徴とする請求項1乃至6のうちのいずれか一項に記載の血液透析システム。
- 前記システムは、前記重炭酸混合物が前記導電性カセットにおける予め設定された閾値を満たさない場合に、前記重炭酸混合物を排液路に送るべく前記混合カセットを制御するように構成されることを特徴とする請求項7に記載の血液透析システム。
- 前記システムは、重炭酸混合物を生成するために外部重炭酸容器に水を送るべく前記混合カセットを制御するように構成され、前記重炭酸混合物は、前記伝導性カセットにおけるさらなる混合または導電性試験のために前記混合カセットに続いて送られることを特徴とする請求項1乃至8のうちのいずれか一項に記載の血液透析システム。
- 前記システムは、透析溶液を前記導電性カセットに送るとともに前記混合カセットに戻すべく前記混合カセットを制御するように構成されるとともに、前記透析液が前記導電性カセットにおける予め設定された閾値を満たす場合に、前記透析液を前記透析液容器に送るように構成されることを特徴とする請求項1乃至9のうちのいずれか一項に記載の血液透析システム。
- 前記システムは、透析液が前記導電性カセットにおける予め設定された閾値を満たさない場合に、前記透析液を排液路に送るべく前記混合カセットを制御するように構成されることを特徴とする請求項10に記載の血液透析システム。
- 前記システムは、透析液の温度が前記導電性カセットにおける予め設定された閾値を満たさない場合に、前記透析液を透析液ヒータ(1506)から排液路に送るべく前記配向カセットを制御するように構成されることを特徴とする請求項1乃至11のうちのいずれか一項に記載の血液透析システム。
- 前記システムは、透析液の導電性が前記導電性カセットにおける予め設定された閾値を満たさない場合に、前記透析液を透析液限外濾過装置(1508)から排液路に送るべく前記配向カセットを制御するように構成されることを特徴とする請求項1乃至12のうちのいずれか一項に記載の血液透析システム。
- 前記配向カセットと連通する動脈接続ポートおよび静脈接続ポートをさらに備え、これらの前記ポートは、前記血流回路の動脈血液管および静脈血液管を備えた前記配向カセットに接続されるように構成され、前記システムは、前記血流回路からエアトラップからなる再循環流路を通じて前記血流回路に流体を戻すべく前記配向カセットを制御するように構成され、該エアトラップは、排液路に接続され、前記システムは、前記血流回路内で殺菌流体を再循環させるとともに空気を前記エアトラップを通じて排出するように構成されることを特徴とする請求項1乃至13のうちのいずれか一項に記載の血液透析システム。
- 前記再循環流路は、前記血流回路において再循環する流体の導電性の測定用の導電性センサを含むことを特徴とする請求項14に記載の血液透析システム。
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