JP2010519006A - 腹膜透析センサ装置システム、機器、及び方法 - Google Patents
腹膜透析センサ装置システム、機器、及び方法 Download PDFInfo
- Publication number
- JP2010519006A JP2010519006A JP2009551804A JP2009551804A JP2010519006A JP 2010519006 A JP2010519006 A JP 2010519006A JP 2009551804 A JP2009551804 A JP 2009551804A JP 2009551804 A JP2009551804 A JP 2009551804A JP 2010519006 A JP2010519006 A JP 2010519006A
- Authority
- JP
- Japan
- Prior art keywords
- cassette
- thermal well
- conductivity
- dialysate
- sensing probe
- 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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Images
Classifications
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
- F04B43/00—Machines, pumps, or pumping installations having flexible working members
- F04B43/02—Machines, pumps, or pumping installations having flexible working members having plate-like flexible members, e.g. diaphragms
- F04B43/025—Machines, pumps, or pumping installations having flexible working members having plate-like flexible members, e.g. diaphragms two or more plate-like pumping members in parallel
- F04B43/026—Machines, pumps, or pumping installations having flexible working members having plate-like flexible members, e.g. diaphragms two or more plate-like pumping members in parallel each plate-like pumping flexible member working in its own pumping chamber
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Abstract
Description
サ装置システムを含む腹膜透析実行システムが提供される。システムは、腹膜透析サイクラと、感知端及びコネクタ端を有する前記サイクラ内の温度センサと、前記温度センサの感知端に熱的に結合されると共に、前記サイクラに取り付けられるプローブチップと、プローブチップは、カセットに装着されたウェルの内面と熱的に結合するように適応させられ、前記温度センサのコネクタ端に結合される少なくとも2個のリードとを含むことにより、熱エネルギは、前記ウェルから前記温度センサへ伝達され、且つ温度情報は、前記リードを通り運ばれる。様々な代替実施形態において、感知プローブは更に、1個のプローブハウジングに取り付けられる第3リードと、温度センサと、伝導率感知を許容するプローブチップとを含んでよい。或いは、感知プローブは更に、1個のプローブハウジングに取り付けられる伝導率センサと、温度センサと、伝導率感知を許容するプローブチップと、伝導率情報を伝達するために伝導率センサに取り付けられる第3リードとを含んでよい。ウレタン樹脂が、前記プローブチップ及び前記プローブハウジングの間に含まれてもよい。プローブチップは、ハウジングと係合するためのフランジを含んでよい。
本発明の一態様によれば、ウェルは、熱伝導性材料の中空ハウジングを含む。ハウジングは、外面及び内面を有する。内面は、感知プローブと係合関係をつくるように、所定の形状をなす。係合は、内面を感知プローブと熱的に結合させる。
本発明の一態様によれば、カセット内の透析液の温度、及び/又は伝導率を決定する方法が開示される。本方法は、以下の工程を含む:少なくとも1個のウェルを、カセットに装着する工程;温度及び伝導率が決定され得るように、ウェル及び感知プローブを熱的に結合させる工程;温度及び伝導率信号を、感知プローブから少なくとも3個のリードを通じて伝達する工程;及び信号を使用して、温度及び伝導率を決定する工程。
或いは、ウェルは、例えば、圧入接続、可撓性タブ、接着剤、超音波溶接、及び保持板と固定具の少なくとも1つを使用して、カセットに結合されてよい、Oリングが、ウェル及び第3導管の間に載置されてもよい。Oリングは、円形断面、正方形断面、及びX形状断面の中の1つを含んでよい。導管と接触するウェルの一部は、導管を変形させるように可撓性を有してよく、またこの可撓性をもたらすために、複数の切れ目を含んでよい。
1.カセット式システムを利用する腹膜透析
図1は、例証カセット式自動化腹膜透析システム10を示す。システム10は、3個の主要構成部品を含む。これらは、セット12(カセットを含む)、液体を汲み上げるために、カセットと相互作用するサイクラ14(図1及び図2に示される)、及び選択されたAPD手順を実行するために相互作用を制御する制御装置16である。例示される好適な実施形態において、サイクラ及び制御装置は、共通のハウジング82内に位置させられる。
カセット24は、典型的なAPD処置が必要とする液体流を、多数の液体源及び行き先の中へ向けるために、サイクラ14及び制御装置16と関連して作用する。後に更に詳細に説明されるように、カセット24は、選択されたAPD治療を実行する際に、集中化させられたバルブ機能及びポンプ機能をもたらす。
向くカセット24の側面である。
カセット24は好適には、剛性医療グレードプラスチック材料から作られる。ダイアフラム59/61は好適には、医療グレードプラスチックの可撓性シートから作られる。ダイアフラム59/61は、それらの外周周りで、カセット24の前側及び後側58/60の周縁に密封される。
典型的なAPD治療セッションは通常、5個の液体源/行先を必要とする。本発明の特徴を具体化したカセット24は、5個の外部液体ライン(即ち、可撓性管26から32)、2個のポンプ室P1及びP2、9個の内部液路F1からF9、及び10個のバルブステーションV1からV10とのこれらの接続をもたらす。
液路F1からF9は、カセット24の後側60で開放する長手状導管として形成される。直立縁62は、カセット24の後側60で、開放導管を円周方向に包囲する。
F1からF9に沿って、円周方向シールを形成する。作動に際して、サイクラ14はまた、まさにこの目的のために、ダイアフラム61へ正の力を付与する。
2.代替透析システム及び方法
予め混合された袋(図1において、20及び22として示されるもの等)に入れられた透析液は、多様な調合物を含んでよい。これらの調合物の特定のものは、ことによると他の点では望ましいが、安定していなくてよく、或いは他のあまり好ましくない溶液ほど安定していなくてもよい。例えば、幾つかの調合物において、二酸化炭素は、袋材料を通過し得、次に残りの炭酸カルシウムは、水溶液から落ちるかもしれない。透析液調合物が安定しておらず、或いは他の水溶液ほど安定していない状況では、透析液の袋は安定していない時には、透析液の調合物が変わったか否か、及び/又は透析液がPD治療への使用に安全であるか否かに関する重要な情報は、溶液の伝導率に基づいて決定されてよい。
か否かに関する大切な情報は、水溶液の伝導率に基づいて決定されてよい。
3.腹膜透析用センサ装置を備えたカセット
図7A〜図7Cは、概して上述されたものと同様な種類の可撓性膜カセットの別の例証実施形態を示す。図7A〜図7Cは、例証カセット2300の後面図、側面図、及び前面図である。図7A〜図7Cに示すように、カセット2300は、図7に示される後側2310、及び図7Cに示される前側2311を有する射出成形体を含む。可撓性ダイアフラム(その一つが、図24において、59として示される)は、カセット2300の前側及び後側の上に重なる。
センサの種類に応じて、使用されてもよい。
それ故、これらの実施形態において、中間領域5404及び下側領域5406は、単一の領域であってよい。しかしながら、例証実施形態において、下側領域5406は、サーマルウェルを流体ラインの領域に圧入するのを助けるように整形され、またサーマルウェル5100を、流体ライン5108に配置及び/又は固定してもよい。他の実施形態において、領域5406は、様々な結合方法(図19A〜図19J、図19L〜図19Sを参照)を容易にするように形成されてよい。
施形態において、感知プローブは、感知ポート2305及び2306(図7A〜図7C及び24に示されるような感知ポート2305及び2306)に直接的に装着されてよい。可撓性膜と合わせて使用されるセンサ装置及びセンサ装置システムの更なる実施形態において、感知プローブは、サーマルウェルと共に使用されてよい。
感知装置の多くの異なる実施形態は、以下に説明されるものと同様の実施形態を含み、可撓性カセットに装着されるサーマルウェルと関連して使用されてよい。幾つかの寸法が説明されているが、多くの他のものも、所望の性能特性を得るために示され得る。
、感知プローブを付勢する他のあらゆる装置が、使用されてよい。
ート2305及び2306の間に配置される透析液の伝導率を感知するために使用され得る。しかしながら、他の実施形態において、一方のセンサのみが、センサ装置の実施形態の一つ、又は感知プローブの実施形態のひとつであり、また第2センサは、当該技術分野で周知の電気式センサである。従って、本明細書で説明されるシステムにおいて、伝導率及び温度は、本明細書で説明されるセンサ装置の一つ又はセンサプローブの一つのいずれかと、第2の静電容量センサ、或いは本明細書で説明されるセンサ装置の一つ又はセンサプローブの一つと、電気式センサを使用することにより感知され得る。
路で、或いはカセット内の全ての流路で測定されてよい。
4代替サーマルウェル実施形態
サーマルウェルの代替実施形態は、しばしば流体ラインと関連して説明される。殆どの実施形態において、流体ラインは、上述される例示カセット2300の流路等、カセットの流路であり得る。或いは、以下に説明される原則は、本明細書で説明されるいずれのカセットの実施形態のいずれにも適用可能であり得る。
る。しかしながら、サーマルウェル5100の形状は、他の変動要素と同様に、センサ装置の使用目的に基づいて、一部が決定される。説明のために、例証実施形態が本明細書で説明される。しかしながら、例証実施形態における形状は、限定するものであると意味されない。
る断面形状を有し得る。
5.感知プローブ実施形態
直接センサ接触、サーマルウェルの使用を介するセンサインタフェース、又は様々な使い捨て及び再利用可能な構成部品を伴う他の方法を含むセンサインタフェース用システム、機器、及び方法の様々な実施形態が説明される。このセンサインタフェース用システム、機器、及び方法は、多様なセンサと共に、且つ多様な用途で使用され得る。このセンサインタフェース用システム、機器、及び方法は、多様なセンサ実施形態と共に使用するように、或いは特定の状況での使用に、決して限定されるものではない。
6018は含まない代替実施形態を示す。
6.センサ装置及びセンサ装置システム
センサ装置の説明のために、センサ装置は、例証実施形態に関して説明される。例証実施形態は、図26,図27,及び図30に、図28及び図29の代替例証実施形態と共に示されている。センサ装置の代替実施形態において、感知プローブは、サーマルウェルの外側で使用され得る。しかしながら、センサ装置は既に、本明細書に単独で説明されている。従って、以下の説明は、本目的のために、感知プローブ及びサーマルウェルを含むセンサ装置の例証実施形態の一実施形態を説明する。
、リード6018は、透析液の伝導率を決定し得る機器と連通する。透析液の伝導率決定に関して、リード6018に加えて、第2の電気リード/接触子(図示なし)も使用され得る。第2リードは、図30に示されるような第2センサ装置であり、或いはそれに代えて、図30に示されるセンサ装置と必ずしも同じではない第2プローブ熱エポキシ又は熱グリース6022の使用によりであり得るが、むしろ電気接触子を含む透析液の静電容量を感知できるプローブ又は装置であり得る。
次に図28及び図29を参照すると、代替例証実施形態において、感知プローブ5800がサーマルウェル5100と結合される一方、図示される寸法を有するチップ5802は、サーマルウェル5100及びチップ5802の内部領域5404及び5406の間に、空気間隙6402を形成する。空気間隙6402は、5802の感知チップの上端のみが、サーマルウェル5100の上側領域5402と連通するように、絶縁障壁をもたらす。
次に図31を参照すると、サーマルウェル5100と結合された感知プローブ6602を示す代替実施形態が示されている。この説明のために、感知プローブ6602のある実施形態及びサーマルウェル5100のある実施形態が使用され得る。本実施形態において、感知プローブ6602のチップ及びサーマルウェル5100の間の熱的に結合を高めるために、熱グリース6604は、感知プローブ6602のチップとサーマルウェル5100の内側領域5402の境界部に存在する。一実施形態において、熱グリース6604の量は、もっぱら領域5402に存在するのに十分な量である。しかし代替実施形態において、より多量又はより少量の熱グリースが使用され得る。
00及び感知プローブ6000は、ハウジング6708に配置される。ハウジング6708は、いかなる機械、容器、機器、又はその他のものの中にあってもよい。ばね6700は、円錐形、コイルばね、ウェーブスプリング、又はウレタンばねであり得る。
いる。これらの実施形態において、ばね、即ち可撓性部材6900の代替実施形態は、感知プローブ6000のハウジング6708内での垂直方向の移動を許容するために、感知プローブ6000と一体化されている。保持板6902は、可撓性部材6900及び感知プローブ6000を保持するために、可撓性部材6900を捕らえる。一実施形態において、保持板6902は、ねじを使用して、ハウジング6708に取り付けられる。しかし代替実施形態において、保持板6902は、接着剤、可撓性タブ、圧入、及び超音波溶接を限定することなく含むあらゆる固定方法を使用して、ハウジング6708に取り付けられる。感知プローブ6000の横方向への移動は、ハウジング6708の領域6908における間隙によって規定される。ワイヤ6710が示されている。ワイヤはリードを入れている。幾つかの実施形態において、2個のリードが存在する。これら実施形態のいくつかは、温度感知である。他の実施形態において、ワイヤは3個又はそれ以上のリードを入れている。これら実施形態のいくつかは、温度及び伝導率感知のためである。
Claims (11)
- 腹膜透析を行うためのカセットであって、
透析液用流路と、
前記流路内に延出するサーマルウェルとを含み、該サーマルウェルは、
熱伝導性材料よりなる中空ハウジングを含み、該ハウジングは外面及び内面を有し、該内面は、感知プローブとの係合関係をつくるように、所定形状を有しており、該係合は前記内面を感知プローブと、ひいてはサーマルウェルと熱的に結合させる
ことを特徴とするカセット。 - 前記カセットはまた、少なくとも1個のポンプ室を含むことを特徴とする請求項1に係るカセット。
- 前記カセットはまた、少なくとも1個のバルブステーションを含むことを特徴とする請求項1に係るカセット。
- 前記カセットはまた、少なくとも1個のポンプ室及び1個のバルブステーションを含むことを特徴とする請求項1に係るカセット。
- 腹膜透析に使用される透析液の温度及び伝導率を決定する方法であって、
少なくとも1個のサーマルウェルを入れているカセットを供給する工程と、
温度及び伝導率が決定され得るように、前記サーマルウェル及び感知プローブを熱的に結合させる工程と、
温及び伝導率信号を、前記感知プローブから少なくとも3個のリードを介して伝達する工程と、
前記信号を使用して、温度及び伝導率を決定する工程と
を含むことを特徴とする方法。 - 腹膜透析に使用される透析液の温度及び伝導率を、透析液の温度及び伝導率を得るために決定する方法であって、
少なくとも1個のサーマルウェルを入れているカセットを供給する工程と、
温度及び伝導率が決定され得るように、サーマルウェル及び感知プローブを熱的に結合させる工程と、
温度及び伝導率信号を、前記感知プローブから、少なくとも3個のリードを介して伝達する工程と、
前記信号を使用して、温度及び伝導率を決定する工程と、
前記決定された伝導率を、所定の伝導率レベルと比較する工程と
を含むことを特徴とする方法。 - 前記方法は更に、前記決定された伝導率が、前記所定の伝導率レベルの特定範囲内にないならば、腹膜透析実行機器に信号を送る工程を含むことを特徴とする請求項6に係る方法。
- 前記方法は更に、前記決定された伝導率が、前記所定の伝導率レベルの特定範囲内にないならば、腹膜透析治療を一時中止する工程を含むことを特徴とする請求項7に係る方法。
- カセット内に透析液用流路を含む腹膜透析装置であって、導管を通過する透析液の温度伝達及び伝導率感知許可の少なくとも一方のためのサーマルウェルを含み、該サーマルウェルは、センサとの相互接続に適応させられることを特徴とする装置。
- 前記ウェルの一部が、前記流路の流体と接触するように構成されることを特徴とする請求項9に係る装置。
- 前記ウェルは、圧入接続、可撓性タブ、接着剤、超音波溶接、及び保持板と固定具の少なくとも1つを使用して、前記カセットに連結されることを特徴とする請求項9に係る装置。
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US (21) | US8317492B2 (ja) |
EP (11) | EP4302818A3 (ja) |
JP (25) | JP5174044B2 (ja) |
KR (17) | KR102061802B1 (ja) |
CN (4) | CN101678159B (ja) |
AU (7) | AU2008221455B2 (ja) |
BR (3) | BRPI0808038B8 (ja) |
CA (10) | CA2681914C (ja) |
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WO (2) | WO2008106440A1 (ja) |
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