JP5349310B2 - 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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- JP5349310B2 JP5349310B2 JP2009527618A JP2009527618A JP5349310B2 JP 5349310 B2 JP5349310 B2 JP 5349310B2 JP 2009527618 A JP2009527618 A JP 2009527618A JP 2009527618 A JP2009527618 A JP 2009527618A JP 5349310 B2 JP5349310 B2 JP 5349310B2
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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
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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
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
- A61M2205/502—User interfaces, e.g. screens or keyboards
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- 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
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- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Urology & Nephrology (AREA)
- Hematology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Emergency Medicine (AREA)
- Cardiology (AREA)
- External Artificial Organs (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
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。
本発明は、さらに以下の手段を提供する。
(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)
上記透析液供給源は、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)
上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、上記可撓性シートは、(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、上記少なくとも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)
上記少なくとも1つの流路は、上記第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)
上記ポンプ部分は、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)
上記ポンプ部分は、上記第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)
上記流路は、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、上記少なくとも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、上記第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)
上記少なくとも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)
上記少なくとも1つの流路は、上記第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)
上記第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)
上記第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)
上記第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)
上記使い捨てユニットは、第3のシートを含み、上記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)
上記バランスチャンバ部分の区画は、上記使い捨てユニットの上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)
上記使い捨てユニットは、上記第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)
上記ポンプは、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、上記可撓性シートは、(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上記少なくとも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)
上記少なくとも1つの流路は、上記第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)
上記流路は、少なくとも1つの弁座を含み、上記少なくとも1つの弁座は、上記少なくとも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、上記第1、第2、および第3のシートは、上記少なくとも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)
上記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)
上記第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)
上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、上記第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)
上記第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)
上記第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)
上記少なくとも1つの流入経路および上記少なくとも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)
上記使い捨てユニットの上記ポンプ部分は、該使い捨てユニットの上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)
上記第2のシートは、上記第1および第3のシートの間に位置し、上記少なくとも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)
上記第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)
上記第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)
上記第2のシートは、上記第1および第3のシートの間に位置し、上記活性化された接着剤は、該第1および第2のシートの間の上記流路の第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)
上記第2のシートは、上記第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)
上記第1、第2、および第3のシートは、上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、上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、上記少なくとも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)
上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)
上記剛性部材は、上記少なくとも1つの流路を画定し、上記第1および第2のシートは、上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)
上記可撓性シートは、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)
上記使い捨てユニットは、上記少なくとも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)
上記バランスチャンバ部分は、上記剛性部材と上記第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)
上記バランスチャンバ部分を上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)
上記ポンプ部分は、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)
上記第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) 上記使い捨てユニットは、第3のシートを含み、上記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)
上記使い捨てユニットは、上記第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)
上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)
上記バランスチャンバ作動装置は、上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。
Claims (15)
- 透析液供給ラインと、
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)該透析液供給ライン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の可撓性シートと第2の可撓性シートとを含む、使い捨てユニットであって、該使い捨てユニットは、剛性フレームがなく、該少なくとも1つの弁作動装置と該少なくとも1つのポンプ作動装置とは、該使い捨てユニットの外部表面に作用することにより、バルビングとポンピングとを実行するように構成される、使い捨てユニットと、
該少なくとも1つの弁作動装置および該少なくとも1つのポンプ作動装置の筐体であって、該筐体は、該使い捨てユニットを受容するように構成される、筐体と
を備える、腎不全治療システム。 - 前記使い捨てユニットは、第3の可撓性シートをさらに含み、該第3の可撓性シートは、前記少なくとも1つのポンプ部分またはバランスチャンバを形成するように、前記第1および第2の可撓性シートのうちの少なくとも1つに密閉される、請求項1に記載の腎不全治療システム。
- 前記使い捨てユニットは、腹膜透析、血液透析、血液濾過または血液透析濾過のために構成され、ポートに対する複数のコネクタ本体をさらに備え、該コネクタ本体は、前記可撓性シートのうちの2つの可撓性シートの間に密閉される、請求項1または2に記載の腎不全治療システム。
- 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、請求項1〜3のいずれか一項に記載の腎不全治療システム。
- ヒータをさらに含み、前記可撓性シートは、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、加熱経路を形成するように共に密閉される、請求項1〜4のいずれか一項に記載の腎不全治療システム。
- 前記少なくとも1つのポンプ作動装置は、(i)蠕動ポンプ作動装置であって、前記少なくとも1つのポンプ部分は、該蠕動ポンプ作動装置のローラヘッドで動作するように構成される、実質的に円形の流体経路を含む、蠕動ポンプ作動装置と、(ii)膜ポンプ作動装置であって、該少なくとも1つのポンプ部分は、膜ポンプとして構成される、膜ポンプ作動装置とのうちの1つである、請求項1〜5のいずれか一項に記載の腎不全治療システム。
- 前記使い捨てユニットは、前記筐体の可動扉と固定部分との間に受容される、請求項1〜6のいずれか一項に記載の腎不全治療システム。
- 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、請求項1〜7のいずれか一項に記載の腎不全治療システム。
- バランスチャンバ、弁座および流路のうちの少なくとも1つを形成する剛性部分をさらに含む、請求項1〜8のいずれか一項に記載の腎不全治療システム。
- 前記使い捨てユニットは、血液カセットであり、前記剛性部分は、空気分離チャンバを含む、請求項9に記載の腎不全治療システム。
- 前記腎不全治療システムは、血液透析のために構成され、前記使い捨てユニットは、透析液をポンピングするように構成され、
少なくとも1つの血流経路と少なくとも1つの血液ポンプ部分とを形成するように共に密閉される少なくとも2つの可撓性シートから構成される血液カセットをさらに備える、請求項1〜10のいずれか一項に記載の腎不全治療システム。 - 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、請求項1〜11のいずれか一項に記載の腎不全治療システム。
- 前記可撓性シートは、(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、請求項1〜12のいずれか一項に記載の腎不全治療システム。
- 前記第2および第3の可撓性シートは、該第2および第3の可撓性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、請求項2に記載の腎不全治療システム。
- 前記可撓性シートのうちの少なくとも2つの可撓性シートの間の少なくとも1つのシールは、機械的締め付けを介して形成され、該可撓性シートのうちの2つの可撓性シートの間の少なくとも1つのシールは、別の方法を使用して形成される、請求項2に記載の腎不全治療システム。
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