JP2013059678A - 可撓性シートの使い捨てユニットを有する医療用流体システム - Google Patents
可撓性シートの使い捨てユニットを有する医療用流体システム Download PDFInfo
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- JP2013059678A JP2013059678A JP2013000322A JP2013000322A JP2013059678A JP 2013059678 A JP2013059678 A JP 2013059678A JP 2013000322 A JP2013000322 A JP 2013000322A JP 2013000322 A JP2013000322 A JP 2013000322A JP 2013059678 A JP2013059678 A JP 2013059678A
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- cassette
- pump
- fluid
- blood
- dialysate
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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
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- A61M1/1621—Constructional aspects thereof
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- A61M1/1639—Constructional aspects thereof with volume chamber balancing devices between used and fresh dialysis fluid linked by membranes
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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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3368—Temperature
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
- A61M2205/502—User interfaces, e.g. screens or keyboards
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
Abstract
【解決手段】上記血液透析システムは、透析装置と、透析液供給源と、透析液ポンプと、透析液ポンプに動作するように接続された透析液カセットであって、それにより、透析液カセットが透析液供給源と流体連通している場合、透析液ポンプは、透析液カセットを通して透析液を送り出し得る、透析液カセットと、血液ポンプと、血液ポンプに動作するように接続された血液カセットであって、それにより、血液ポンプは、血液カセットを通して血液を送り出し得、血液カセットは、剛性筐体と、剛性筐体に取り付けられた可撓性膜とを含み、筐体は、患者からのチューブコネクタと、患者へのチューブコネクタと、透析装置へのチューブコネクタと、透析装置からのチューブコネクタとを含み、可撓性膜は、血液カセットの患者へのラインを開閉するための弁座を画定する、血液カセットとを含む。
【選択図】図26A
Description
本出願は、米国特許出願第10/982,170号(2004年11月4日出願、名称「High Convection Home Hemodialysis/Hemofiltration And Sorbent System」)の優先権および一部係属出願としての利益を主張するものである。
以下に考察される実施例は、概して、医療用流体送達に関する。特に、実施例は、腎不全治療システムにおける流量の制御のためのシステム、方法、および装置を開示する。
例えば、本発明は以下の項目を提供する。
(項目1)
透析液供給源と、
少なくとも1つの弁作動装置と、
少なくとも1つのポンプ作動装置と、
(i)該透析液供給源と流体連通して設置され、かつ、該少なくとも1つの弁作動装置で動作するように構成される、少なくとも1つの流路と、(ii)該少なくとも1つのポンプ作動装置で動作するように構成される、少なくとも1つのポンプ部分とを形成するように、共に密閉される第1および第2の可撓性シートとを含む、使い捨てユニットと
を備える、腎不全治療システム。
(項目2)
前記透析液供給源は、新鮮な透析液の容器およびオンライン透析液生成システムのうちの少なくとも1つを含む、項目1に記載の腎不全治療システム。
(項目3)
前記ポンプ作動装置は、蠕動ポンプおよび膜ポンプから成る群から選択される種類のものである、項目1に記載の腎不全治療システム。
(項目4)
ヒータを含み、前記可撓性シートは、(i)該ヒータと動作可能に連通して配置されるように構成される、加熱経路、または(ii)該ヒータと動作可能に連通して配置される加温バッグと流体連通するように構成される、前記少なくとも1つの流路を形成するように共に密閉される、項目1に記載の腎不全治療システム。
(項目5)
前記少なくとも1つの流路は、前記第1および第2の可撓性シートの間に密閉される、少なくとも1つのポートと連通しており、該ポートは、外部の透析液導管との流体連通を可能にする、項目1に記載の腎不全治療システム。
(項目6)
前記ポンプ部分は、蠕動ポンプ作動装置の少なくとも1つのローラヘッドで動作するように構成される、少なくとも実質的に円形の流体経路を含む、項目1に記載の腎不全治療システム。
(項目7)
前記ポンプ部分は、前記第1および第2のシートが、ダイアフラムポンプ作動装置の空洞へと外側に開くことができるように構成される、項目1に記載の腎不全治療システム。
(項目8)
前記流路は、少なくとも1つの弁座を画定し、該少なくとも1つの弁座は、前記少なくとも1つの弁作動装置で動作するように構成される、項目1に記載の腎不全治療システム。
(項目9)
少なくとも1つのセンサを含み、前記第1および第2のシートは、該少なくとも1つのセンサで動作するように構成される少なくとも1つの感知領域を形成するようにさらに協働する、項目1に記載の腎不全治療システム。
(項目10)
前記少なくとも1つの流路は、負の動作圧を受けると、その形状を少なくとも実質的に維持するように構成される、項目1に記載の腎不全治療システム。
(項目11)
前記少なくとも1つの流路は、前記第1および第2のシートを共に密閉する前に、該第1および第2のシートのうちの少なくとも1つに該流路を熱成形することを介して構成される、項目1に記載の腎不全治療システム。
(項目12)
前記第1および第2のシートは、(i)熱シール、(ii)超音波シール、(iii)高周波シール、(iv)溶剤結合、および(v)機械的締め付けから成る群から選択される、少なくとも1つのプロセスを介して共に密閉される、項目1に記載の腎不全治療システム。
(項目13)
前記第1および第2のシートは、血流経路を形成するように密閉される、項目1に記載の腎不全治療システム。
(項目14)
前記第1および第2のシートは、(i)少なくとも1つの透析液供給源の流入経路と、(ii)ポンプへの経路と、(iii)ポンプからの経路と、(iv)少なくとも1つのヒータ経路と、(v)少なくとも1つの患者経路を形成するように密閉される、項目1に記載の腎不全治療システム。
(項目15)
前記使い捨てユニットは、第3のシートを含み、前記3つのシートは、少なくとも1つのバランスチャンバ部分を形成するように密閉される、項目1に記載の腎不全治療システム。
(項目16)
前記バランスチャンバ部分の区画は、前記使い捨てユニットの前記ポンプ部分と流体連通している、項目15に記載の腎不全治療システム。
(項目17)
前記使い捨てユニットは、前記第1および第2のシートと動作可能に連通している、マニホールドまたはフレームを含む、項目15に記載の腎不全治療システム。
(項目18)
透析液供給源と、
少なくとも1つの弁作動装置と、
少なくとも1つのポンプ作動装置と、
(i)該透析液供給源と流体連通して設置され、かつ、該少なくとも1つの弁作動装置で動作するように構成される少なくとも1つの流路と、(ii)該少なくとも1つのポンプ作動装置で動作するように構成される少なくとも1つのポンプ部分とを形成するように、共に密閉される、第1、第2、および第3の可撓性シートとを含む、使い捨てユニットと
を備える、腎不全治療システム。
(項目19)
前記ポンプは、蠕動ポンプおよび膜ポンプから成る群から選択される種類である、項目18に記載の腎不全治療システム。
(項目20)
ヒータを含み、前記可撓性シートは、(i)該ヒータと動作可能に連通して配置されるように構成される加熱経路、または(ii)該ヒータと動作可能に連通して配置される加温バッグと流体連通するように構成される前記少なくとも1つの流路を形成するように、共に密閉される、項目18に記載の腎不全治療システム。
(項目21)
前記少なくとも1つの流路は、前記第1および第2の可撓性シートの間に密閉される、少なくとも1つのポートと連通しており、該ポートは、返りの透析液導管との流体連通を可能にする、項目18に記載の腎不全治療システム。
(項目22)
前記流路は、少なくとも1つの弁座を含み、前記少なくとも1つの弁座は、前記少なくとも1つの弁作動装置で動作するように構成される、項目18に記載の腎不全治療システム。
(項目23)
少なくとも1つのセンサを含み、前記第1、第2、および第3のシートは、前記少なくとも1つのセンサで動作するように構成される、少なくとも1つの感知領域を形成するようにさらに協働する、項目18に記載の腎不全治療システム。
(項目24)
前記3つのシートのうちの少なくとも2つは、血流経路を形成するように密閉される、項目18に記載の腎不全治療システム。
(項目25)
前記第1、第2、および第3のシートは、少なくとも1つのバランスチャンバ部分を形成するように密閉され、該第1および第3のシートは、第1および第2のバランスチャンバ壁に向かって外側に引かれるように構成され、該第2のシートは、該第1および第3のシートの間に維持され、かつ、該引き離された第1および第3のシートに向かって、前後に押されるように構成される、項目18に記載の腎不全治療システム。
(項目26)
前記ポンプ作動装置と弁作動装置とを収納する筺体を含み、該筺体は、前記第1および第2のチャンバ壁を含む、項目25に記載の腎不全治療システム。
(項目27)
前記第1および第2のシートは、該第1および第2のシートの間に形成される第1の区画と流体連通している、少なくとも1つの流入経路と少なくとも1つの流出経路とを画定するように密閉される、項目25に記載の腎不全治療システム。
(項目28)
前記第2および第3のシートは、該第2および第3のシートの間に形成される第2の区画と流体連通している、少なくとも1つの流入経路と少なくとも1つの流出経路とを画定するように密閉される、項目27に記載の腎不全治療システム。
(項目29)
前記少なくとも1つの流入経路および前記少なくとも1つの流出経路に動作可能に連結される、少なくとも1つの弁作動装置を含む、項目27に記載の腎不全治療システム。
(項目30)
前記使い捨てユニットの前記ポンプ部分は、該使い捨てユニットの前記バランスチャンバ部分と流体連通している、項目25に記載の腎不全治療システム。
(項目31)
前記第2のシートは、前記第1および第3のシートの間に位置し、前記少なくとも1つの流体路は、該第1および第2のシートの間に形成される第1の部分と、該第2および第3のシートの間に形成される第2の部分とを有し、該第2のシートは、該少なくとも1つの流路の該第1および第2の部分の間の流体連通を可能にする開口を画定する、項目18に記載の腎不全治療システム。
(項目32)
前記第1、第2、および第3のシートは、(i)熱シール、(ii)超音波シール、(iii)高周波シール、(iv)溶剤結合、(v)接着結合、および(vi)機械的締め付けから成る群から選択される、少なくとも1つのプロセスを介して共に密閉される、項目18に記載の腎不全治療システム。
(項目33)
前記第1、第2、および第3のシートの少なくとも一部は、該第1、第2、および第3のシートのうちの1つに提供される接着剤を活性化することによって共に密閉される、項目18に記載の腎不全治療システム。
(項目34)
前記第2のシートは、前記第1および第3のシートの間に位置し、前記活性化された接着剤は、該第1および第2のシートの間の前記流路の第1の部分と、該第2および第3のシートの間の該流路の第2の部分とを形成し、該第3のシートは、該第1および第2の部分の間の流体連通を可能にする開口を画定する、項目33に記載の腎不全治療システム。
(項目35)
前記第2のシートは、前記第1および第3のシートの間に位置し、該第1のシートは、該第2のシートが、そのような密閉を達成するために利用される密閉プロセス中に使用されるエネルギー量を制御することを介して、該第3のシートに対応して密閉されることなく、該第2のシートに密閉される、項目25に記載の腎不全治療システム。
(項目36)
前記第1、第2、および第3のシートは、前記使い捨てユニットの第1の部分を形成し、該第1および第2のシートは、該使い捨てユニットの第2の部分のみを形成する、項目35に記載の腎不全治療システム。
(項目37)
3つのシートすべての間の少なくとも1つのシールは、機械的締め付けを介して形成され、該シートのうちの2つの間の少なくとも1つのシールは、別の方法を使用して形成される、項目35に記載の腎不全治療システム。
(項目38)
透析液供給源と、
少なくとも1つの弁作動装置と、
少なくとも1つのポンプ作動装置と、
(i)該透析液供給源と流体連通して設置され、かつ、該少なくとも1つの弁作動装置で動作するように構成される少なくとも1つの流路と、(ii)該少なくとも1つのポンプ作動装置で動作するように構成される少なくとも1つのポンプ部分とを形成するように、共に密閉される剛性部材と、第1および第2の可撓性シートとを含む、使い捨てユニットと
を備える、腎不全治療システム。
(項目39)
ヒータを含み、前記可撓性シートおよび剛性部材は、(i)該ヒータと動作可能に連通して配置されるように構成される、加熱経路、または(ii)該ヒータと動作可能に連通して配置される加温バッグと流体連通するように構成される、前記少なくとも1つの流路、を形成するように共に密閉される、項目38に記載の腎不全治療システム。
(項目40)
前記使い捨てユニットは、透析液ユニットであり、かつ、別個の使い捨て血液ユニットを含む、項目38に記載の腎不全治療システム。
(項目41)
前記剛性部材は、前記少なくとも1つの流路を画定し、前記第1および第2のシートは、前記ポンプ部分を形成する、項目38に記載の腎不全治療システム。
(項目42)
前記可撓性シートは、流体の加熱経路をさらに形成する、項目41に記載の腎不全治療システム。
(項目43)
前記使い捨てユニットは、前記少なくとも1つのポンプ部分と流体連通している、少なくとも1つのバランスチャンバ部分を含む、項目38に記載の腎不全治療システム。
(項目44)
前記バランスチャンバ部分は、前記剛性部材と前記第1および第2のシートとを使用して形成される、項目43に記載の腎不全治療システム。
(項目45)
前記バランスチャンバ部分を前記ポンプ部分に接続する、少なくとも1つのチューブを含む、項目43に記載の腎不全治療システム。
(項目46)
体外回路と、
少なくとも1つの弁作動装置と、
少なくとも1つのポンプ作動装置と、
(i)該体外回路と流体連通して設置され、かつ、該少なくとも1つの弁作動装置で動作するように構成される少なくとも1つの流路と、(ii)該少なくとも1つのポンプ作動装置で動作するように構成される少なくとも1つのポンプ部分とを形成するように、共に密閉される第1および第2の可撓性シートを含む、使い捨てユニットと
を備える、腎不全治療システム。
(項目47)
前記ポンプ部分は、蠕動ポンプ作動装置の少なくとも1つのローラヘッドで動作するように構成される、少なくとも実質的に円形の流体経路を含む、項目46に記載の腎不全治療システム。
(項目48)
前記第1および第2のシートは、(i)少なくとも1つの血液流入経路と、(ii)ポンプへの経路と、(iii)ポンプからの経路と、(iv)少なくとも1つのヒータ経路と、(v)少なくとも1つの患者経路とを形成するように密閉される、項目46に記載の腎不全治療システム。
(項目49)
前記使い捨てユニットは、第3のシートを含み、前記3つのシートは、少なくとも1つのバランスチャンバ部分を形成するように密閉される、項目46に記載の腎不全治療システム。
(項目50)
前記使い捨てユニットは、前記第1および第2のシートと動作可能に連通している、マニホールドまたはフレームを含む、項目46に記載の腎不全治療システム。
(項目51)
透析液供給源と、
少なくとも1つの弁作動装置と、
少なくとも1つの電磁バランスチャンバ作動装置と、
(i)該透析液供給源と流体連通して設置され、かつ、該少なくとも1つの弁作動装置で動作するように構成される少なくとも1つの流路と、(ii)該少なくとも1つの電磁的に作動したバランスチャンバ作動装置で動作するように構成される、少なくとも1つのバランスチャンバ部分とを形成するように、共に密閉される第1、第2、および第3の可撓性シートを含む、使い捨てユニットと
を備える、腎不全治療システム。
(項目52)
前記シートのうちの少なくとも1つは、強磁性体を含む、項目51に記載の腎不全治療システム。
(項目53)
前記バランスチャンバ作動装置は、前記膜のうちの少なくとも1つを動かすように選択的に電力供給される、第1および第2の電磁石を含む、項目51に記載の腎不全治療システム。
PVC、ポリブタジエン(「PB」)、エチレン酢酸ビニル(「EVA」)、ポリプロピレン(「PP」)ブレンド、ポリエチレン(「PE」)ブレンド、Kratonブレンド、およびポリオレフィンブレンド等の任意の好適な医療グレード配管材料であることができる。流体経路42aを含む外部流体ヒータバッグ40に使用される材料は、PVC、PP/kratonブレンドを含む。
Claims (23)
- 血液透析システムであって、該血液透析システムは、
透析装置と、
透析液供給源と、
透析液ポンプと、
該透析液ポンプに動作するように接続された透析液カセットであって、それにより、該透析液カセットが該透析液供給源と流体連通している場合、該透析液ポンプは、該透析液カセットを通して透析液を送り出し得、該透析液カセットは、該透析装置と流体連通している、透析液カセットと、
血液ポンプと、
該血液ポンプに動作するように接続された血液カセットであって、それにより、該血液ポンプは、該血液カセットを通して血液を送り出し得、該血液カセットは、剛性筐体と、該剛性筐体に取り付けられた可撓性膜とを含み、該筐体は、患者からのチューブコネクタと、患者へのチューブコネクタと、透析装置へのチューブコネクタと、透析装置からのチューブコネクタとを含み、該可撓性膜は、該血液カセットの患者へのラインを開閉するための弁座を画定し、該患者へのラインは、該患者へのチューブコネクタと流体連通している、血液カセットと
を含む、血液透析システム。 - 前記透析装置からのチューブコネクタと前記患者へのチューブコネクタとに流体的に接続された内部空気分離チャンバを含む、請求項1に記載の血液透析システム。
- 前記血液カセットをプライミングするためのチューブコネクタをさらに含む、請求項1に記載の血液透析システム。
- 前記血液カセットは、前記剛性筐体の外側に延在する血液ポンピングチューブを介して前記血液ポンプに動作可能に接続されており、該血液ポンピングチューブは、前記患者からのチューブコネクタと前記透析装置へのチューブコネクタとに流体的に接続されている、請求項1に記載の血液透析システム。
- 前記複数のチューブコネクタのうちの少なくとも1つは、チュープポートである、請求項1に記載の血液透析システム。
- 前記透析装置へのチューブコネクタは、動作中、前記患者へのチューブコネクタの上方に位置している、請求項1に記載の血液透析システム。
- 前記透析装置へのチューブコネクタは、動作中、前記患者からのチューブコネクタの上方に位置している、請求項1に記載の血液透析システム。
- 前記透析装置へのチューブコネクタは、動作中、前記血液カセットの頂部の上方に位置している、請求項1に記載の血液透析システム。
- 前記患者からのチューブコネクタと、前記患者へのチューブコネクタと、前記透析装置へのチューブコネクタと、前記透析装置からのチューブコネクタとのうちの少なくとも1つは、それぞれのチューブを受容するために、前記筐体の外壁から外側へ延在する、請求項1に記載の血液透析システム。
- 前記血液カセットは、前記血液ポンプへの動作可能な接続のためのポンピングチューブをさらに含む、請求項1に記載の血液透析システム。
- 血液ポンピングチューブは、線形蠕動血液ポンピングチューブである、請求項10に記載の血液透析システム。
- 少なくとも1つの圧力センサを含み、前記血液カセットは、該少なくとも1つの圧力センサとの動作可能な係合のために位置決定および配列された少なくとも1つの圧力感知領域をさらに含む、請求項1に記載の血液透析システム。
- 動脈および静脈圧力センサ、係合動脈、および前記血液カセット上の静脈圧力感知領域を含む、請求項12に記載の血液透析システム。
- 前記血液カセットの前記筐体の内部のラインが、弁で調整される、請求項1に記載の血液透析システム。
- 血液透析システムであって、該血液透析システムは、
透析装置と、
血液ポンプと、
新鮮および使用済み透析液ポンプと、
剛性筐体と、該剛性筐体に取り付けられた可撓性膜とを含むカセットと
を含み、
該剛性筐体は、該カセットを通して血液を送り出すために、該血液ポンプに動作するように接続された血液ポンピングチューブを含み、該筐体は、患者からのチューブコネクタと、患者へのチューブコネクタと、透析装置へのチューブコネクタと、透析装置からのチューブコネクタと、該カセットの患者へのラインを開閉するための、該可撓性膜によって画定された弁座と、該患者へのチューブコネクタと流体連通している該患者へのラインと、該新鮮透析液ポンプに動作するように接続可能な新鮮透析液ポンピングチューブと、該使用済み透析液ポンプに動作するように接続可能な使用済み透析液ポンピングチューブとをさらに含む、血液透析システム。 - 前記複数のチューブコネクタのうちの少なくとも1つは、チュープポートである、請求項15に記載の血液透析システム。
- 前記カセットは、該血液カセット内の血液から除去された空気を排出するための通気孔をさらに含む、請求項15に記載の血液透析システム。
- 前記カセットは、前記筐体内において形成された空気分離チャンバを含む、請求項15に記載の血液透析システム。
- 血液透析システムであって、該血液透析システムは、
透析装置と、
血液ポンプと、
筐体を含む血液カセットと
を含み、
該筐体は、該筐体の第1の側に沿って延在するポンピングチューブを含み、該ポンピングチューブは、該血液カセットを通して血液を送り出すために、該血液ポンプに動作するように接続されており、該筐体は、患者からのチューブコネクタと、患者へのチューブコネクタと、生理食塩水/プライミングチューブコネクタと、透析装置へのチューブコネクタと、透析装置からのチューブコネクタとをさらに含み、該複数のコネクタの各々は、該筐体の該第1の側と異なる該筐体の側に沿って延在する、血液透析システム。 - 前記複数のチューブコネクタの各々は、前記筐体の前記第1の側に対向する該筐体の側に沿って延在する、請求項19に記載の血液透析システム。
- 前記複数のチューブコネクタのうちの少なくとも1つは、チュープポートである、請求項19に記載の血液透析システム。
- 前記血液カセットおよび前記透析液カセットは、単一のカセット内に一体化されている、請求項1に記載の血液透析システム。
- 前記血液ポンピングチューブ、前記新鮮透析液ポンピングチューブ、および前記使用済み透析液ポンピングチューブは、各々、線形蠕動ポンピングチューブである、請求項15に記載の血液透析システム。
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