JP7009347B2 - センサ装置システム、機器及び方法 - Google Patents
センサ装置システム、機器及び方法 Download PDFInfo
- Publication number
- JP7009347B2 JP7009347B2 JP2018213006A JP2018213006A JP7009347B2 JP 7009347 B2 JP7009347 B2 JP 7009347B2 JP 2018213006 A JP2018213006 A JP 2018213006A JP 2018213006 A JP2018213006 A JP 2018213006A JP 7009347 B2 JP7009347 B2 JP 7009347B2
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- sensor
- cassette
- fluid
- thermal
- thermal well
- Prior art date
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Images
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Landscapes
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- Investigating Or Analyzing Materials Using Thermal Means (AREA)
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Description
本願発明の一つの態様に従って、ウェルは、熱伝導性材料の中空のハウジングを含む。ハウジングは外面と内面とを有する。内面は、検出プローブと嵌め合い関係を形成するような所定の形状である。この嵌め合いは、内面と検出プローブとを熱的に結合する。
本願発明の一つの態様に従って、カセット内の対象媒体の温度及び導電性を判定する方法が記載される。この方法は、カセット内に少なくとも一つのウェルを設置する工程と、温度と導電性とが判定できるようにウェルと検出プローブとを熱的に結合する工程と、検出プローブから少なくとも三つのリード線を通じて熱及び導電性信号を転送する工程と、この信号を使用して温度と導電性とを判定する工程を含む。
あるいはまた、ウェルはカセットに、例えば圧入連結と、可撓性タブと、接着剤と、超音波溶接と、保持プレート及び締結具と、のうちの少なくとも一つを使用して結合される。オーリングがウェルと流体導管との間に配置され得る。オーリングは円形断面、四角形断面、及びX形状の断面の一つを含み得る。ウェルは、オーリングの一部を受容するための溝を含み得る。導管と接触するウェルの一部は、導管を変形させるために可撓性を有し、上記可撓性を提供するために複数の切込み部を含み得る。
上述の図面及び図面に記載された構成要素は、必ずしも一貫した尺度又は寸法で描かれていないことに留意されたい。文脈が他に示唆しない限り、同様な構成要素が同様な符号によって示される。
この明細書の説明及び添付の特許請求の範囲において使用されるように、以下の用語は、文脈が他に要求しない限り、ここで示された意味を有する。
「球形」は、一般的な球形を意味する。
「流体」は、例えば流動路を通って送られることが可能な物質、液体を意味する。血液は流体の特定の例示である。
「対象媒体」は、検出プローブと直接的に、又はサーマルウェル、センサ伸長ピン、及び一つ以上のセンサにそのような対象媒体の特性に関する情報を転送するための他の機器等を介して間接的に接触する、任意の流体、固体、液体又はガスを含む任意の材料である。
一つの例示の実施形態において、サーマルウェルは、温度検出プローブ等のセンサプローブを収容するために使用される。サーマルウェルは対象媒体(例えば血液又は透析液等の液体)と直接接触し、検出プローブは対象媒体と直接接触しない。サーマルウェルと検出プローブ構造との熱力学的特性によって大部分が決定される熱伝導に基づいて、検出プローブは、対象媒体と直接接触すること無しに対象媒体の特性を判定できる。センサ装置構成の正確性及び効率性が、構造、材料及びプローブとサーマルウェルの両方の形状を含む多くの要因に依存するが、これらの要因に制限されない。
図7Mを参照すると、流体路5108にインサート成形されるサーマルウェル5100が示される。ゾーン5406は、周囲を覆う流体路5108におけるプラスチックに適したフランジである。この実施形態に示されるように、フランジは平坦であるが、他の実施形態では、フランジはベル形または他の形状となり得る。
直接センサ接触、サーマルウェルの使用を通じたセンサインターフェースを含む、システム、機器、及びセンサインターフェースのための方法の様々な実施形態、又は様々な使い捨ての及び再利用される構成要素を有する他の実施形態が記載される。このようなシステム、機器及びセンサインターフェースのための方法が多様なセンサと共に使用され、広範の用途に使用される。このようなシステム、機器、及びセンサインターフェースのための方法は、様々なセンサの実施形態と共に使用する又は任意の特定の状況において使用することを決して制限しない。
3.1 流体路に接続して使用される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、例示の実施形態におけるセンサ装置が説明される。例示の実施形態は、図14A,14Bに示される別の例示の実施形態とともに、図13A,13B及び図15に示される。センサ装置の別の実施形態においては、センサプローブはサーマルウェルの外側で使用される。しかしながら、センサ装置は既に本明細書において単独で説明されている。従って、後の説明においては、この目的のために、センサプローブとサーマルウェルとを含んだセンサ装置の例示の実施形態の一実施形態について説明する。
図14A,14Bに示すように、別の例示の実施形態においては、センサプローブ5800はサーマルウェル5100に結合され、図示されたような形状を有する先端5802はサーマルウェル5100の内側領域5404,5406と先端5802との間にエアギャップ6402を形成する。エアギャップ6402は、5802の検知先端の上部のみがサーマルウェル5100の上部領域5402に接続するように断熱障壁を供する。
図16に示すように、サーマルウェル5100に結合したセンサプローブ6602を示す別の例示の実施形態が示される。この説明のために、センサプローブ6602の任意の実施形態及びサーマルウェル5100の任意の実施形態が使用される。本実施形態において、センサプローブ6602の先端とサーマルウェル5100との間の熱的な結合を高めるために、センサプローブ6602とサーマルウェル5100の内側領域5402との接触領域には熱グリース6604が配置されている。一実施形態において、熱グリース6604の量は前記領域5402に対して配置されているだけで十分である。しかしながら、別の実施形態においては、熱グリースの量を多くしても少なくしてもよい。
この記載で示され、かつ説明されるカセットの実施形態は、例示のまたはいくつかの別の実施形態を含む。しかしながら、同様なまたは付加的な機能性を含んだ様々なカセットが意図されている。その上で、可変な流体路及び/またはバルブ位置を有し、またはポンプ機能、バルブ機能、及び/またはその他のカセット機能を利用するものであってもよい。全ての実施形態は本願発明の範囲内にある。
1994年9月27日に発行された米国特許第5350357号の「腹膜の透析システム及び液体分配を採用する方法及び重力流を模倣したポンプカセット」、1998年5月26日に発行された第5755683号の「静脈ライン流制御システム用カセット」、2001年4月24日に発行された第6223130号の「流体流制御システムの膜の漏れを検出する装置及び方法」、2001年5月22日に発行された第6234997号の「静注薬物を混合及び搬送する装置及び方法」、2005年6月14日に発行された第6905479号の「集積化フィルタを備えたポンプカートリッジ及びカートリッジで流体を濾過する方法」、2003年4月10日出願の米国特許出願第10412658号の「流体の目標量を配分するシステム及び方法」、2003年10月30日出願の米国特許出願第10/696990号の「ポンプカセット貯蔵物」に記載された種類の可撓性膜流体カセットを含む、流体カセットは、その出願の全ての内容が参照されて盛り込まれ、ここで記載されたセンサ装置及びセンサ装置システムに関連して使用される。
例示のカセット2300はウェル及びチャネルの形状をなす内部空洞の配列を形成している。例示のカセット2300においては、内部空洞は、流体経路2303のような、液体(図23Aに示す)を運ぶための多数の流体路を形成している。例示のカセット2300において、内部空洞はまた、ポンプチャンバー2301,2302(図23Cに示す)のようなポンプチャンバー及びバルブステーション2304(図23Cに示す)のような多数のバルブステーションを形成する。例示のカセット2300において、バルブステーション2304のようなバルブステーションは、流体経路2303のような多数の流体経路とポンプチャンバー2301,2302と、及びポンプチャンバー2301,2302同士を相互に連結させている。
センサ装置の多くの異なった実施形態は可撓性カセット内に設置されたサーマルウェルに接続されて使用され、図14A~B、図15及び図16に示した、及び、上述したものと同様な実施形態を含む。
特定の実施形態において、例示のカセット2300は、バルブステーション及びポンプチャンバーを覆う隔膜領域上で、米国特許第5350357号及び他の特許及び上記した特許出願に記載された正又は負の流圧を含む、局所的に正圧及び負圧を供給する機器(図示しない)とともに使用されてもよい。カセット2300が圧力供給装置(図示しない)とともに使用される場合、カセット2300は多くの異なった方法及び多くの異なった位置で装置に接続している。好ましくは、特定の実施形態において、カセット2300は装置に垂直又は実質的に垂直方向といったように水平方向以外の方向に装着されている。垂直又は実質的に垂直な方向へのカセットの配置は、空気の閉じ込めを回避し、正圧及び負圧の供給を最適化するというカセットの形状に応じた利点を提供し、米国特許第5350357号及び他の特許及び上記した特許出願に記載された、カセットに対する、正又は負の流圧を含む。
上述した可撓性膜カセット以外のカセットはここで上述したセンサ装置及びセンサ装置システムとともに使用されてもよい。2007年4月13日(E77)に出願された特許出願第11/787213号の「熱交換システム、装置及び方法」、2007年4月13日(E79)に出願された特許出願第11/787213号の「導電性センサシステム、装置及び方法」に記載の種類のカセットは、その出願の全ての内容が参照されて盛り込まれ、ここで記載されたセンサ装置及びセンサ装置システムに関連して使用される。また、カセット、カセットアッセンブリ及び以下の出願に記載された種類のマニホールドがここで記載されたセンサ装置及びセンサ装置システムとともに使用される。以下の出願とは、2007年10月12日に出願された米国特許出願第11/871680号の「ポンプカセット」(代理人整理番号DEKA-019XX)、2007年10月12日に出願された米国特許出願第11/871712号の「ポンプカセット」(代理人整理番号DEKA-020XX)、2007年10月12日に出願された米国特許出願第11/871787号の「ポンプカセット」(代理人整理番号DEKA-021XX)、2007年10月12日に出願された米国特許出願第11/871793号の「ポンプカセット」(代理人整理番号DEKA-022XX)、2007年10月12日に出願された米国特許出願第11/871803号の「カセットシステム集積化装置」(代理人整理番号DEKA-023XX)。さらに、「血液透析システム及び方法」と題する米国特許出願(代理人整理番号D0570/70019US00)、及び「カセットシステム集積化装置」と題する米国特許出願(代理人整理番号F62)ばかりでなく、2007年10月12日に出願された米国特許出願第11/871680号の「ポンプカセット」(代理人整理番号DEKA-019XX)に記載された血液透析システム及び方法といった医療機器を含む多くの機器は、その出願の全ての内容が参照されて盛り込まれる。
図34は本発明の例示の実施形態に従ったシステム10を示す。システム10はベースユニット11及びマニホールドを含む使い捨てユニット16を含んでいる。使い捨てユニット16は一般に、患者の治療の後に破棄されるという点で「使い捨て」という意味である。一方、ベースユニット11は新規の使い捨てユニット16を単に装着することで繰り返し再使用することはが可能である。
ここに記載される本発明の様々な実施形態において、センサ装置システムは、センサマニホールドを含んで利用される。センサマニホールドは、対象媒体が一つの環境からセンサ読込みを得るためにより高い導電性を有する別の環境に移動されることを可能とする。例えば、カセットマニホールドは、検出プローブ等のセンサ装置により好ましくない、温度及び/又は湿度等の環境状態の様々な様式に影響を受けない領域に含まれ得る。あるいはまた、検出装置及び検出装置システムは、繊細であり、システムの他の構成要素より故障し易いプローブを有する。センサマニホールドを使用してシステムの残り部分からセンサ装置とセンサ装置システムとを分離することによって、検出装置と検出装置システムとが、最小限の影響で修理又はシステムの残り部分と取り替えられることが可能となる。あるいはまた、センサマニホールドは、システムの他の構成要素より多く又は少ない頻度のいずれかで取り替えられ得る。
検出装置の多くの異なる実施形態が、上述の図14A~14B、図15及び図16に示される同様な実施形態を含む、可撓性カセットマニホールドに設置されたサーマルウェルと接続して使用され得る。
ある実施形態において、検出装置は、カセットの流体ライン内の対象媒体の導電性を検出するために使用される。ある実施形態において、これはさらに温度検出にも使用される。これらの実施形態において、温度及び導電性の両方の検出が所望される場合であって、リード線の2つが温度検出のために使用され、第三のリード線が導電性検出のために使用され得る時は、検出プローブは一般的に少なくとも三つのリード線を含む。
ここで記述される発明の様々な実施形態において、センサマニホールドを備えるセンサ装置を備える、流体処理のためのシステム及び方法が利用される。このような実施形態の例は、様々な形態の透析、心臓バイパス、及び他の体外治療及び療法のような様々な体液及び/又は治療薬のポンピング、測定、計量、制御、及び/又は分析を伴うシステム及び方法の実施形態を含む様々な医学的状態の診断、治療、又は改善のためのシステム及び方法を含むであろう。更なる例は、水処理システム、水分蒸留システム、及び透析液のような診断、治療、又は改善に利用される流体を含む流体を準備するためのシステムを含む流体処理及び準備を含む。
Claims (6)
- センサマニホールドとセンサ装置とを有する血液透析装置のための検出システムであって、
前記センサマニホールドは、互いに独立した2つ以上の流体通路を包囲するハウジングを有し、前記流体通路の各々は、
前記検出システムの使用中には、前記血液透析装置の透析液流体通路または血液流体通路に連結されるとともに、
前記透析液流体通路または前記血液流体通路からの流体流を受領し、同流体流を前記透析液流体通路または前記血液流体通路へと通過させるための流体流入口と流体流出口とを有し、
前記センサ装置は、前記センサマニホールドと関連するとともに、前記流体通路の各々における温度及び導電性の少なくとも一つを検出するように構成され、
前記センサ装置は、検出プローブを有する複数のセンサを有し、少なくとも一つのセンサは温度検出が可能な検出プローブを有し、少なくとも一つのセンサは導電性検出が可能な検出プローブを有し、
前記流体通路の各々は、前記センサマニホールドの前記ハウジング内において、前記流体通路に延びる少なくとも一つのウェルを有し、前記ウェルの各々は、前記流体通路と関連するセンサを形成するように、前記センサ装置の各検出プローブと相互連結するように適合され、
導電性検出をするように構成された前記流体通路の各々は、互いに離間した少なくとも二つのウェルを有し、同少なくとも二つのウェルは、導電性検出が可能な各検出プローブと相互連結するように適合され、
前記センサマニホールドは弁及びポンプ機構を備えておらず、前記血液透析装置の他の構成要素から分けられており、前記センサ装置の前記検出プローブと相互連結されると、前記検出システムを、前記血液透析装置のために流体の導電性と温度とを検出可能にする、検出システム。 - 導電性検出用の前記検出プローブはサーミスタを有する、請求項1に記載の検出システム。
- 前記センサ装置はプリント回路基板を有し、前記検出プローブは同プリント回路基板に連結されるとともに、前記流体通路に延びる、請求項1に記載の検出システム。
- 前記プリント回路基板はエッジコネクタを有し、対応するエッジコネクタレシーバに接続するように構成される、請求項3に記載の検出システム。
- 前記血液透析装置の使用時に、各流体通路は異なる組成又は特性の液体を含む対象媒体を収容する請求項1に記載の検出システム。
- 前記液体は透析液に用いられる重炭酸塩溶液及び酸溶液を含む請求項5に記載の検出システム。
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EP (11) | EP2131886B1 (ja) |
JP (25) | JP5174044B2 (ja) |
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CN (4) | CN101678159B (ja) |
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