JP5054073B2 - 腹膜透析を実施するためのシステムおよび方法 - Google Patents
腹膜透析を実施するためのシステムおよび方法 Download PDFInfo
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- JP5054073B2 JP5054073B2 JP2009179279A JP2009179279A JP5054073B2 JP 5054073 B2 JP5054073 B2 JP 5054073B2 JP 2009179279 A JP2009179279 A JP 2009179279A JP 2009179279 A JP2009179279 A JP 2009179279A JP 5054073 B2 JP5054073 B2 JP 5054073B2
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- A61M1/156—Constructional details of the cassette, e.g. specific details on material or shape
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Description
本発明は、全体として透析システムに関する。より具体的には、本発明は、再生透析システムおよび持続注入透析システムに関する。本発明はまた、透析治療を行う方法にも関する。
全体として、本発明は、改善された透析システムおよび透析を行う改善された方法を提供する。より詳細には、本発明は、持続注入透析(「CFD」)および再生型透析、ならびに組み合わせられた持続注入再生型透析(「CFRD」)用のシステムおよび方法を提供する。本発明はまた、血液透析を行うための改善されたシステムおよび方法をも含む。
本発明は、例えば、以下の項目を提供する。
(項目1)
透析を提供するシステムであって、
第1のポンプおよび複数の患者管腔を含む患者流体ループと、
第2のポンプおよび医療用流体再生装置を含む第2の流体ループと、
該患者流体ループ内の該流体の少なくとも1つの選択された成分が該第2の流体ループへ移動することを可能にする、該患者流体ループおよび該第2の流体ループと流体接触し且つそれらを分離する膜装置とを備え、
該第2のループは、該膜装置を介する該選択された成分の移動を除いて閉鎖されており、
該第1のポンプと第2のポンプを作動させて該患者ループおよび該第2のループ内に流体を再循環させる制御装置と、
を備えるシステム。
(項目2)
前記膜装置は透析器である、項目1に記載の透析システム。
(項目3)
前記膜装置の両側に圧力勾配が存在する、項目1に記載の透析システム。
(項目4)
前記患者ループは、前記膜装置を介する前記選択された成分の移動を除いて閉鎖されている、項目1に記載の透析システム。
(項目5)
前記膜装置は、尿素が前記患者流体ループから前記第2の流体ループへ通過することを可能にするナノフィルタを含む、項目1に記載の透析システム。
(項目6)
前記医療用流体再生装置は、尿毒症毒素吸収剤を含む、項目1に記載の透析システム。
(項目7)
前記医療用流体再生装置は、ウレアーゼ、リン酸ジルコニウム、酸化ジルコニウム、および炭素のうちの少なくとも1つを含む、項目1に記載の透析システム。
(項目8)
前記患者流体ループおよび第2の流体ループのうちの少なくとも1つからガスを除去するガス分離器を含む、項目1に記載の透析システム。
(項目9)
前記ガス分離器および前記医療用流体再生装置が、単一の装置内に備えられている、項目8に記載の透析システム。
(項目10)
前記患者流体ループおよび第2の流体ループからガスを排気するガス排気口を含む、項目1に記載の透析システム。
(項目11)
前記第2の流体ループは、前記医療用流体内の電解質の濃度を監視する多検体センサを含む、項目1に記載の透析システム。
(項目12)
腹膜透析用流体が前記患者流体ループを通って循環する、項目1に記載の透析システム。
(項目13)
血液が前記患者流体ループを通って循環する、項目1に記載の透析システム。
(項目14)
前記患者流体ループおよび前記第2の流体ループの少なくとも部分が使い捨て装置内に備えられる、項目1に記載の透析システム。
(項目15)
前記第2の流体ループは、前記第2の流体ループ内の流れのバランスをとるバランスチャンバを含む、項目1に記載の透析システム。
(項目16)
前記制御装置は、流体が前記複数の患者を通って反対方向に流れることを可能にする、項目1に記載の透析システム。
(項目17)
前記複数の患者管腔を規定する二重管腔カテーテルを含む、項目1に記載の透析システム。
(項目18)
前記患者流体ループおよび前記第2の流体ループのうちの少なくとも1つは、インライン流体ヒータを含む、項目1に記載の透析システム。
(項目19)
前記インライン流体ヒータは、放射ヒータおよびプレートヒータを含む、項目18に記載の透析システム。
(項目20)
アンモニア、アンモニウムおよびpHからなる群から選択される少なくとも1つの指標を感知する少なくとも1つの医療用流体センサを含む、項目1に記載の透析システム。
(項目21)
前記患者流体ループおよび第2の流体ループのうちの少なくとも1つに流体量センサを含む、項目1に記載の透析システム。
(項目22)
前記流体量センサは、前記少なくとも1つの流体ループと流体連通するチャンバを用いるキャパシタンス流体量センサを含む、項目21に記載の透析システム。
(項目23)
前記チャンバは、ポンプチャンバである、項目22に記載の透析システム。
(項目24)
前記患者流体ループおよび第2の流体ループのうちの少なくとも1つと流体連通する限外濾過液容器を含む、項目1に記載の透析システム。
(項目25)
前記患者流体ループおよび第2の流体ループのうちの少なくとも1つと流体連通する流体濃縮液容器を含む、項目1に記載の透析システム。
(項目26)
前記制御装置は、前記第1のポンプを作動させて患者の内外へ持続的に流体をポンプ輸送する、項目1に記載のシステム。
(項目27)
使い捨て透析カセットであって、以下:
患者ポンプチャンバおよび再生ポンプチャンバを覆う可撓性の膜と、
該患者ポンプチャンバを閉鎖ループ患者流体経路に流体接続する手段と、
該再生ポンプチャンバを閉鎖ループ再生流体経路へ流体接続する手段であって、ここで、該患者経路は、透析器を介して該再生経路と流体接続する、手段
を備える、使い捨て透析カセット。
(項目28)
透析物吸収剤カートリッジと流体連通する流体経路を規定する、項目27に記載の使い捨て透析カセット。
(項目29)
ガス分離器と流体連通する流体経路を規定する、項目27に記載の使い捨て透析カセット。
(項目30)
透析濃縮液容器と流体連通する流体経路を規定する、項目27に記載の使い捨て透析カセット。
(項目31)
透析液の最終バッグと流体連通する流体経路を規定する、項目27に記載の使い捨て透析カセット。
(項目32)
透析液バッグと流体連通する流体経路を規定する、項目27に記載の使い捨て透析カセット。
(項目33)
排液容器と流体連通する流体経路を規定する、項目27に記載の使い捨て透析カセット。
(項目34)
患者流体コネクタと流体連通する流体経路を規定する、項目27に記載の使い捨て透析カセット。
(項目35)
使い捨てカセットと共に用いるための透析治療装置であって、以下:
該使い捨てカセットを受け入れる部分を有するハウジングと、
少なくとも一部分が該使い捨てカセットによって規定される患者経路を通して流体をポンプ輸送する、該ハウジング内の患者ポンプ作動装置と、
少なくとも一部分が該使い捨てカセットによって規定される再生経路を通して流体をポンプ輸送する、該ハウジング内の再生ポンプ作動装置
を備える、透析治療装置。
(項目36)
前記患者ポンプ作動装置および前記再生ポンプ作動装置のうちの少なくとも1つと協働する少なくとも1つの流体量測定センサ構成要素を含む、項目35に記載の透析治療装置。
(項目37)
前記ハウジングは、流体ヒータを格納する、項目35に記載の透析治療装置。
(項目38)
前記ハウジングは、アンモニアセンサ、アンモニウムセンサおよびpHセンサからなる群から選択される少なくとも1つのセンサを格納する、項目35に記載の透析治療装置。
(項目39)
前記ハウジングは、前記使い捨てカセットと共に作動する少なくとも1つのバルブ作動装置を格納する、項目35に記載の透析治療装置。
(項目40)
透析システム内の流体を移動させる方法であって、
患者ループを通して第1の流体を持続的に再循環させる工程と、
再生ループを通して第2の流体を持続的に再循環させる工程と、
該患者ループから該再生ループへ、両方のループによって共有される装置を通して少なくとも1つの老廃成分を移送する工程であって、該ループは、該装置を通る該移送を除き閉鎖されている工程と、
該再生ループから少なくとも1つの老廃成分を除去する工程を含む、
方法。
(項目41)
前記第1の流体と第2の流体が、透析液を含む、項目40に記載の方法。
(項目42)
前記第1の流体は血液を含み、前記第2の流体は透析液を含む、項目40に記載の方法。
(項目43)
前記老廃成分を除去する工程が、前記再生ループ内の前記第2の流体を老廃物吸収剤を通して流し、前記老廃成分のうちの少なくとも一部を吸収する工程を包含する、項目40に記載の方法。
(項目44)
前記第1の流体と第2の流体のうちの少なくとも1つを加熱する工程を含む、項目40に記載の方法。
(項目45)
前記第1の流体と第2の流体のうちの少なくとも1つから限外濾過液を除去する工程を含む、項目40に記載の方法。
(項目46)
前記第1の流体と第2の流体のうちの少なくとも1つに透析液を加える工程を含む、項目40に記載の方法。
(項目47)
前記第1の流体と第2の流体のうちの少なくとも1つに濃縮液を加える工程を含む、項目40に記載の方法。
(項目48)
前記第1の流体と第2の流体のうちの少なくとも1つからガスを除去する工程を含む、項目40に記載の方法。
(項目49)
前記患者ループおよび前記再生ループのうちの少なくとも1つの中の流体の流れのバランスをとる工程を含む、項目40に記載の方法。
(項目50)
前記患者ループおよび前記再生ループのうちの少なくとも1つの中の流体の流れの量を感知する工程を含む、項目40に記載の方法。
(項目51)
腹膜透析システムにおいて流体を移動させる方法であって、以下の工程:
患者ループ内の容器を通して透析液を持続的に再循環させる工程と、
再生ループ内の該容器を通して透析液を持続的に再循環させる工程と、
両方のループによって共有される該容器を通して該患者ループから該再生ループへ少なくとも1つの老廃成分を持続的に移動させる工程とを含み、該ループは、該容器を通る移送を除き閉鎖されている、
方法。
(項目52)
透析液が前記患者ループを通じて再循環される速度と異なる速度で前記再生ループを通じて透析液を再循環させる工程を含む、項目51に記載の方法。
(項目53)
持続注入腹膜透析を行う方法であって、以下の工程:
閉鎖患者ループを通じて透析流体を持続的に再循環させる工程と、
閉鎖再生ループを通じて再生流体を持続的に再循環させる工程と、
該透析流体および該再生流体を透析器の膜の反対側へ通過させる工程と、
該再生流体が該透析器を出た後に該再生流体を再生する工程と、
を含む、方法。
(項目54)
前記閉鎖患者ループを通じて透析液流体を再循環させる工程は、患者の一部位を通して前記流体を通過させる工程を含む、項目53に記載の方法。
(項目55)
前記閉鎖患者ループを通じて透析液流体を再循環させる工程は、眠っている患者を通して前記流体を通過させる工程を含む、項目53に記載の方法。
(項目56)
前記閉鎖患者ループを通じて透析液流体を再循環させる工程は、夜間に患者を通して前記流体を通過させる工程を含む、項目53に記載の方法。
(項目57)
持続注入透析を行う方法であって、以下の工程:
第1の時点で閉鎖ループ透析装置で持続注入腹膜透析を行う工程と、
第2の時点で同一の閉鎖ループ透析装置を介して持続注入血液透析を行う工程
を含む、方法。
(項目58)
前記持続注入腹膜透析および前記持続注入血液透析は、同一の患者に対して行われる、項目57に記載の方法。
(項目59)
前記装置と共に使用された使い捨てカセットを除去して新しい使い捨てカセットを前記装置に連結する中間工程を含む、項目57に記載の方法。
(項目60)
二重管腔腹膜透析カテーテルを除去して該カテーテルを血液透析針と交換する中間工程を含む、項目57に記載の方法。
(項目61)
血液透析針を除去して該針を二重管腔腹膜透析カテーテルと交換する中間工程を含む、項目57に記載の方法。
全体として、本発明は、透析システムおよび透析を行う方法に関する。一実施形態では、本発明は、持続注入再生腹膜透析システムおよび方法に関する。別の実施形態では、本発明は、非持続注入再生腹膜透析、および持続注入型であり且つ非持続注入型の両方である再生血液透析に関する。
透析システムは、例えば患者が眠っている夜間に患者に対して透析治療を自動的に行う。本発明は、真の持続注入透析治療法(流体が患者の身体の内部および外部へ同時に流れる)を提供し得、且つ使用済み透析液を、透析治療に再度用いられる新鮮な透析液に自動的に再生することができる。透析液の持続注入は、腹膜の両側の浸透勾配を最大化するかまたは最大浸透勾配を維持することによって治療の効率を向上させがちである。本発明による透析液の再生は、治療に要する透析液の量を大幅に減少させる。例えば、既存のサイクラによって行われる場合、透析液流体の量を、CFPD治療に対する約50リットルから、本発明を用いる治療に対する約6リットル〜約8リットルにまで減少させることができる。
ここで図面、特に図1を参照すると、透析治療を必要とする患者にそれを提供するシステム10が示されている。図1に示すように、2つのループ、すなわち患者ループ(患者の流体流路を再循環する)12および再生ループ14(透析液流体の流路を再循環する)が提供されている。しかしながら、本発明は、1つのみまたは2つより多いループを含むシステムに用いることができることに留意されたい。患者ループ12は、腹膜透析の実施形態において患者16を透析液で透析するために用いられる。再生ループ14も透析液を含んでおり、患者ループ12内の透析液を再生するために用いられる。血液透析の実施形態では、患者ループ12が患者の血液を搬送し、再生ループ14が血液を透析し且つループ14内の透析液を再生する。
ここで図2を参照すると、本発明の二重管腔患者流体コネクタ20の一実施形態が、さらに詳細に説明されている。上述したように、二重管腔コネクタ20は、患者管腔に流体を供給するための管腔72および患者から流体を除去するための別個の管腔74を有するハウジング70を含む。各々が管腔72および74のうちの1つを有する別個のハウジングを提供してもよい。患者流入管腔72は、患者ループ12の患者流入チューブ76に接続している。同様に、患者流出管腔74は、患者ループ12の患者流出チューブ78に接続している。ハウジング70によって規定されるキャビティ82を密封するために、除去可能なエンドキャップ80が提供されている。キャビティ82は、管腔72および74を取り囲むかまたはそれらに隣接しており、二重管腔カテーテル22(図1)がキャビティ82内に入って管腔72および74と結合するための接続領域を提供する。
ここで図3を参照すると、患者に透析治療を施すためのシステム100が示されている。図3のシステム100は、図1のシステム10と同じ多くの構成要素を含む。例えば、システム100は、2つのループ、患者ループ12および再生ループ14を含む。患者ループ12は、医療用流体、透析液または血液を患者16を往復して送る。腹膜透析の実施形態では、患者ループ12および再生ループ14は、最初に透析液バッグ18からの透析液で充填ならびにプライミングされる。患者ループ12は、図2に関連して上述した多管腔患者流体コネクタ20によって患者16に流体接続する。腹膜透析の実施形態では、多管腔コネクタ20は、二重管腔カテーテル22に接続する。血液透析の実施形態では、患者ループ12は、多管腔血液透析針または他の患者血液アクセス装置に流体接続する。
ここで図4を参照すると、本発明のシステム110が示されている。図4のシステム110は図3のシステム100に類似しており、閉鎖ループシステムである。システム110は、前述したシステム100の種々の構成要素を含む。システム110は、ポンプ30と共に作動する一対のチャンバ75によって作り出される一対のバランスのとれた(balanced)透析液流体ポンプを有する再生ループ14を有する。各バランスチャンバ75は、膜で分離された一対のチャンバを含む。ポンプ30のうちの1つがバランスチャンバ75の一方のチャンバに医療用流体を充填する場合、膜が他方のチャンバに向けて押され、それにより流体がそのチャンバの外に押し出される。このようにして、膜が再生ループ14内の透析液流体の流れのバランスをとる働きをし、その結果、限外濾過液ポンプ19によって除去される流体と入れ代わるために必要な流れを除き、透析器の膜を通過する流体の正味の流れがなくなる。
ここで図5を参照すると、本発明に従う使い捨てカセット120を有する透析システムが示されている。図3のシステム100のこのバリエーションでは、システム120のポンプ30が、アキュムレータA4およびA6から流体を吸引し、アキュムレータA3およびA5内に排出する。アキュムレータA3〜A6は、ポンピング中の圧力変動を抑制することによって透析液の流れをスムーズにする。一実施形態では、上述した多くの流れの論理および流れ装置の少なくとも幾つかの部分が使い捨てカセット120に備えられている。一実施形態では、カセット120は、種々の流体流チャネルを有する硬質プラスチックの本体122および本体122内に規定された流体チャンバを有する。可撓性の膜が、図5に示すカセット本体122の正面に結合されている。膜は、流体チャネルおよび流体チャンバを覆いかつチャネルおよびチャンバの周りで本体122に密封されている。従って、膜は、流体流経路および流体チャンバの壁を形成している。同様に、カセット本体122の背面も膜で覆うことができる。
ここで図8を参照すると、代替的閉鎖ループ再生システム160が示されている。システム160は概略的に示されているが、システム160は、使い捨てカセット、流体ポンプ、種々のセンサ、バルブおよび制御装置などの上述した使い捨てセットを採用することができる。システム160は、患者流体ループ12および再生ループ14を含む。
ここで図9を参照すると、システム170が示されている。先の図1、図3および図4のシステム10、100および110の各々はそれぞれ、腹膜透析または血液透析に用いることができる。しかしながら、上述のシステムの各々は、主として腹膜透析を使用し説明および図示してきた。すなわち、透析溶液を使用する患者ループを示してきた。システム170は、二重管腔カテーテルまたは2つの単管腔カテーテルを、患者16の腕(もしくは他の適した部位)に接続して血液透析針171を通じて血液を吸引する血液透析針171に代えることができることを示している。
ここで図10を参照すると、一体型の吸収剤カートリッジ、ポンプおよびバルブのシステムが、1つの容器、例えばキャニスタ、カートリッジまたはカセット190内に収納されている。一体型容器190は特に図9のシステム170で説明した構成要素を収容した状態で示されている。しかしながら、一体型容器190は、上述のシステム、すなわちシステム10、100および110のいずれの構成要素の収容に対しても適応可能である。キャニスタ、カートリッジまたはカセットは、プラスチックもしくは金属などの任意の材料から製造するのに適応可能である。容器190は、上述したように構成された吸収剤カートリッジ32を含む。代替的に、容器は、吸収剤カートリッジ32およびガス分離器50を備える一体型装置102を含む。
Claims (13)
- 透析システムと一緒に使用するための使い捨て透析カセットであって、該使い捨てカセットは、以下:
患者ポンプチャンバおよび再生ポンプチャンバを覆う可撓性の膜と、
該患者ポンプチャンバを閉鎖ループ患者流体経路に流体接続する手段と、
該再生ポンプチャンバを閉鎖ループ再生流体経路へ流体接続する手段であって、ここで、該患者経路は、透析器を介して該再生経路と流体連通する、手段
を備える、使い捨て透析カセット。 - 透析物吸収剤カートリッジと流体連通する流体経路を規定する、請求項1に記載の使い捨て透析カセット。
- ガス分離器と流体連通する流体経路を規定する、請求項1に記載の使い捨て透析カセット。
- 透析濃縮液容器と流体連通する流体経路を規定する、請求項1に記載の使い捨て透析カセット。
- 透析液の最終バッグと流体連通する流体経路を規定する、請求項1に記載の使い捨て透析カセット。
- 透析液バッグと流体連通する流体経路を規定する、請求項1に記載の使い捨て透析カセット。
- 排液容器と流体連通する流体経路を規定する、請求項1に記載の使い捨て透析カセット。
- 患者流体コネクタと流体連通する流体経路を規定する、請求項1に記載の使い捨て透析カセット。
- 請求項1に記載の使い捨て透析カセットと共に用いるための透析治療装置であって、以下:
該使い捨て透析カセットを受け入れる部分を有するハウジングと、
該ハウジング内に保持される患者ポンプ作動装置であって、該患者ポンプ作動装置は、前記患者ポンプチャンバにおいて前記可撓性の膜を押圧することにより、前記閉鎖ループ患者流体経路を通して流体を押し進めるように構成される、患者ポンプ作動装置と、
該ハウジング内に保持される再生ポンプ作動装置であって、該再生ポンプ作動装置は、前記再生ポンプチャンバにおいて前記可撓性の膜を押圧することにより、前記閉鎖ループ再生流体経路を通して流体を押し進めるように構成される、再生ポンプ作動装置
を備える、透析治療装置であって、
該装置は、請求項1の透析システムを構成する、透析治療装置。 - 前記患者ポンプ作動装置および前記再生ポンプ作動装置のうちの少なくとも1つと協働する少なくとも1つの流体量測定センサ構成要素を含む、請求項9に記載の透析治療装置。
- 前記ハウジングは、流体ヒータを格納する、請求項9に記載の透析治療装置。
- 前記ハウジングは、アンモニアセンサ、アンモニウムセンサおよびpHセンサからなる群から選択される少なくとも1つのセンサを格納する、請求項9に記載の透析治療装置。
- 前記ハウジングは、前記使い捨て透析カセットと共に作動する少なくとも1つのバルブ作動装置を格納する、請求項9に記載の透析治療装置。
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