JP2014121641A - 流体送達のためのシステムおよび方法 - Google Patents
流体送達のためのシステムおよび方法 Download PDFInfo
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Abstract
【解決手段】医療的状態の少なくとも部分的な閉ループ制御のためのシステムを開示する。システムは、少なくとも1つの医療用流体ポンプを含む。ポンプによって送出される流体の体積を決定するためのセンサを含む、医療用流体ポンプ。また、少なくとも1つの連続的検体モニタ、およびコントローラ。コントローラは、医療用流体ポンプおよび少なくとも1つの連続的検体モニタと通信している。コントローラは、プロセッサを含む。プロセッサは、少なくとも1つの連続的検体モニタから受信されるデータに少なくとも基づく、医療用流体の送達のための命令を含む。
【選択図】図6
Description
本願は、米国仮特許出願第61/097,021号(名称「Systems and Methods for Fluid Delivery(F72)」、2008年9月15日出願)、米国仮特許出願第61/101,053号(名称「Infusion Pump Assembly with a Switch Assembly(F73)」、2008年9月29日出願)、米国仮特許出願第61/101,077号(名称「Infusion Pump Assembly with Tubing Storage(F74)」、2008年9月29日出願)、米国仮特許出願第61/101,105号(名称「Improved Infusion Pump Assembly (F75)」、2008年9月29日出願)、米国仮特許出願第61/101,115号(名称「Filling Apparatus and Methods for an Infusion Pump Assembly(G08)」、2008年9月28日出願)米国仮特許出願第61/141,996号(名称「Acoustic Volume Sensing Methods,Systems and Apparatus (G07)」、2008年12月31日出願)および米国仮特許出願第61/141,781号(名称「Split Ring Resonator Antenna Adapted
for Use in Wirelessly Controlled Medical Device(G81)」、2008年12月31日出願)の優先権を主張する非仮特許出願であり、これらの出願のすべてはその全体が本明細書に参考として援用される。
本発明は、流体の送達に関し、より具体的には、流体送達のためのシステムおよび方法に関する。
(項目1)
医療的状態の少なくとも部分的な閉ループ制御のためのシステムであって、該システムは、
少なくとも1つの医療用流体ポンプであって、該医療用流体ポンプは、該ポンプによって送出される流体の体積を決定するセンサを備える、医療用流体ポンプと、
少なくとも1つの連続的検体モニタと、
コントローラであって、該コントローラは、該医療用流体ポンプおよび該少なくとも1つの連続的検体モニタと通信しており、該コントローラは、プロセッサを備え、該プロセッサは、該少なくとも1つの連続的検体モニタから受信されるデータに少なくとも基づく医療用流体の送達のための命令を備える、コントローラと
を備える、システム。
(項目2)
前記センサは、音響体積センサをさらに備える、項目1に記載のシステム。
(項目3)
ネットワーク操作センターであって、前記プロセッサと通信しているネットワーク操作センターをさらに備える、項目1に記載のシステム。
(項目4)
前記ポンプは、
流体源との流体連通を提供するように接続可能な入口、およびポンプ出口を有する送出チャンバと、
該送出チャンバに圧縮ストロークを提供するように適合される加力アセンブリと
をさらに備え、
該圧縮ストロークは、該送出チャンバからポンプ出口に流体を押し進めながら、該送出チャンバから該入口を通る流体の逆流の制限を引き起こす、項目1に記載のシステム。
(項目5)
前記加力アセンブリは、入口弁アクチュエータおよびポンプアクチュエータに連結され、それにより、該ポンプアクチュエータが、流体を前記送出チャンバから前記ポンプ出口まで押し進めるようにすると、前記圧縮ストロークが、前記入口と前記流体源との間に連結された入口弁を作動させて該弁を閉鎖する、項目4に記載のシステム。
(項目6)
前記加力アセンブリは、前記弁アクチュエータおよび前記ポンプアクチュエータの協調動作のためのモータをさらに備え、該モータは、少なくとも1つの形状記憶アクチュエータを含む、項目5に記載のシステム。
(項目7)
前記連続的検体モニタのうちの少なくとも1つは、連続的グルコースモニタである、項目1に記載のシステム。
(項目8)
少なくとも1つの加速度計をさらに備える、項目1に記載のシステム。
(項目9)
少なくとも1つの血中酸素センサをさらに備える、項目1に記載のシステム。
(項目10)
少なくとも1つの加速度計と、少なくとも1つのジャイロスコープとを備える、少なくとも1つの慣性計測装置をさらに備える、項目1に記載のシステム。
(項目11)
少なくとも1つの温度センサをさらに備える、項目1に記載のシステム。
(項目12)
医療的状態の少なくとも部分的な閉ループ制御のための方法であって、該方法は、
時間枠または事象中のグルコースデータを受信することと、
該グルコースデータを以前の同様の時間枠または事象と比較することと、
該時間枠または該事象中の予期しない結果を決定することと、
予期しない結果を示すために警告信号を送信することと
を含む、方法。
(項目13)
前記警告信号を送信することは、前記予期しない結果についてユーザに警告することをさらに含む、項目12に記載の方法。
(項目14)
前記予期しない結果に関する情報を入力するように前記ユーザを促すことをさらに含む、項目13に記載の方法。
(項目15)
前記システムは、前記ユーザから前記予期しない結果に関する情報を受信せず、該システムをシャットダウンすることをさらに含む、項目14に記載の方法。
(項目16)
前記システムをシャットダウンすることは、一連のアラームを介して、該シャットダウンについて前記ユーザに警告することをさらに含む、項目15に記載の方法。
(項目17)
一連のアラームを介して、前記シャットダウンについて前記ユーザに警告することは、一連の増大するアラームを介して、該シャットダウンについて該ユーザに警告することをさらに含む、項目16に記載の方法。
(項目18)
医療的状態の少なくとも部分的な閉ループ制御のための方法であって、該方法は、
時間枠または事象中の医療用流体送達データを受信することと、
該医療用流体送達データを以前の同様の時間枠または事象と比較することと、
該時間枠または該事象中の予期しない結果を決定することと、
予期しない結果を示すために警告信号を送信することと
を含む、方法。
(項目19)
警告信号を送信することは、前記予期しない結果についてユーザに警告することをさらに含む、項目18に記載の方法。
(項目20)
前記予期しない結果に関する情報を入力するように前記ユーザを促すことをさらに含む、項目19に記載の方法。
(項目21)
前記システムは、前記ユーザから前記予期しない結果に関する情報を受信せず、該システムをシャットダウンすることをさらに含む、項目20に記載の方法。
(項目22)
前記システムをシャットダウンすることは、一連のアラームを介して、該シャットダウンについて前記ユーザに警告することをさらに含む、項目21に記載の方法。
(項目23)
一連のアラームを介して、前記シャットダウンについて前記ユーザに警告することは、一連の増大するアラームを介して、該シャットダウンについて該ユーザに警告することをさらに含む、項目22に記載の方法。
(項目24)
検体センサの完全性を監視するための方法であって、該方法は、
検体に対する連続的検体センサにごく近接して、所定の濃度を有する該検体の体積を注射することと、
該連続的検体センサからデータを受信することと、
該検体センサが該検体の注射体積に応答するか否かを決定するために、該データを分析することと
を含む、方法。
(項目25)
さらに、前記検体は、グルコースである、項目24に記載の方法。
本発明のこれらの側面は、排他的となるように意図されておらず、添付の請求項および添付図面と併せて読むと、本発明の他の特徴、側面、および利点が、当業者にとって容易に明白となるであろう。
Apparatus(G34)と題された米国出願公開第US−2009−0099522号で説明されているようないずれかであってもよい。
Delivery Systems and Methods(E72)と題された前述の米国出願公開第US−2007−0219480号、2007年12月11日に発行され、Loading Mechanism for Infusion Pump(C54)と題された前述の米国特許第7,306,578号、2009年3月3日に発行され、Optical Displacement Sensor for Infusion Devices(D78)と題された前述の米国特許第7,498,563号、または2007年10月4日に公開され、Fluid Delivery Systems
and Methods(E70)と題された前述の米国出願公開第US−2007−0228071号で説明されているポンプは、1つ以上の付加的な貯留部を組み込むようにわずかに改変されてもよい。これらの貯留部は、同じカニューレ、または別個のカニューレに流体的に接続されてもよい。加えて、上記のカニューレの全てについては、その全体で参照することにより本明細書に組み込まれる、2009年4月16日に公開され、Microneedle Systems and Apparatus(G34)と題された米国出願公開第US−2009−0099522号で説明されているもの等のカニューレである。
されなくてもよく、再較正(すなわち、指先穿刺による)が必要とされる。プロセッサが1つのセンサから信号を受信しなければ、プロセッサは、そのセンサを無視するようにプログラムされてもよい。全ての冗長センサが同一または同様の値(再度、事前にプログラムされてもよい、または所定であってもよい割合以内)を読み取る場合には、システムに確信があるほど、値が正確に近い。
1つ以上のホルモンに対する検体センサ、
患者体温を監視するサーミスタ、
医療用流体温度を監視する温度センサ
加速度計、
ジャイロスコープ、
慣性計測装置(「IMU」)、
呼吸数モニタ、
カルボックスシメトリセンサ、
ガルバニック皮膚、
アドレナリンセンサ、
酸素飽和センサ、
水和センサ、
白血球数センサ、および/または
信号伝達ホルモンセンサ。
。いくつかのアラームは、いくつかの実施形態では、進行性アラームであってもよく、すなわち、アラームの種類に応じて、アラームが次第により大きく、または活発になる。アラームは、高血糖、低下する血糖または低い血糖、閉塞、空またはほぼ空の貯留部、取り外されたカニューレ、取り外されたセンサ、または患者が認識することを希望し得る任意の他の状態を含むが、それらに限定されない、無数の状態のうちのいずれかを示すために使用されてもよい。
れてもよい。このプロファイルは、いくつかの実施形態では、予測または感知された低血糖発作を治療するように、ある種類の間食をユーザに推奨するために使用されてもよい。
Products Limited Partnershipに譲渡された米国特許第5,575,310号および第5,755,683号、ならびに米国特許出願公開第US2007/0228071A1号、第US2007/0219496A1号、第US2007/0219480A1号、第US2007/0219597A1の主題である。例えば、ドップラーベースの方法、羽根またはフラッパ弁と組み合わせたホール効果センサの使用、ひずみビームの使用(例えば、可撓性部材の偏向を感知するように、流体貯留部上の可撓性部材に関係付けられる)、プレートを用いた容量性感知の使用、または熱的飛行時間方法といった、流体流量を測定するための他の代替技法も使用されてもよい。1つのそのような代替技法は、その開示全体が参照することによって本明細書に組み込まれる、2007年2月9日出願のFluid Delivery Systems and Methodsと題された米国特許出願第11/704,899で開示されている。注入ポンプアセンブリ100は、容量センサアセンブリ148によって生成される容量測定が、フィードバックループを通して、ユーザに注入される注入可能な流体の量を測定するために使用されてもよいように、構成されてもよい。
式中、Kは、システムの初期条件によって定義される定数である。
この方程式を微分することにより、以下の式をもたらし得る。
音響ポートは、剛体シリンダが軸方向に往復運動するにつれて、ポートの中の流体の全てが本質的に移動することを仮定して、モデル化されてもよい。チャネルの中の流体の全てが同じ速度で移動すると仮定され、チャネルが一定の断面であると仮定され、チャネルに進入し、退出する流体に起因する「末端効果」が無視される。
音響ポートの両側の2つの容量の間の関係は、ポート間伝達関数と呼ばれてもよい。この関係は、以下の通りであり、
圧力は、スピーカの両側からも測定されてもよい。これは、スピーカ間伝達関数と呼ばれ、
共振の質は、共振周波数によって増加させられる電力損失に対する貯蔵されるエネルギーの比である。純粋な二次系について、品質係数は、減衰比の関数として表され得る。
(ポート間位相を使用する容量推定)
可変容量(すなわち、容量センサチャンバ620内)もまた、ポート間位相を使用して推定されてもよい。共振ポートにわたる圧力比の伝達関数は、以下の通りであってもよい。
システムの共振周波数は、掃引正弦波系識別を使用して推定されてもよい。この方法では、正弦波圧力変動へのシステムの応答が、多数の異なる周波数において求められてもよい。次いで、この周波数応答データは、線形回帰を使用してシステム伝達関数を推定するために使用され得る。
式中、yはk×1であり、xはk×(m+n−1)であり、cは(m+n−1)×1である。次いで、係数は、最小二乗法を使用して求められてもよい。誤差関数は、以下のように書かれてもよい。
最小化される関数は、誤差関数の加重二乗である。Wはk×k対角行列である。
(周波数応答データの収集および複素応答の計算)
容量センサアセンブリ148を実装するために、容量センサアセンブリ148は、スピーカアセンブリ622によって設定される音波に対する参照マイクロホン626および不変容量マイクロホン630の相対応答を判定するべきである。これは、既知の周波数における正弦波出力でスピーカアセンブリ622を駆動することによって達成されてもよい。次いで、マイクロホン626、630の複素応答が、その駆動周波数において見出されてもよい。最終的に、マイクロホン626、630の相対応答が見出され、例えば、アナログ/デジタル変換器(すなわち、ADC)によって、交互サンプリングのために補正されてもよい。
マイクロホンからの信号は、1つの波長について固定数の点Nが取られるように、スピーカアセンブリ622への出力と同期してサンプリングされてもよい。波長の各点における測定された信号は、整数の数の波長Mにわたって合計され、その周波数に対する全てのデータが収集された後に処理するために、ISRによって配列xに記憶されてもよい。
信号の疑似分散は、以下の関係式を使用して計算されてもよい。
マイクロホン626、630の相対応答(G)は、個々のマイクロホンの複素応答から計算され得る。
マイクロホン626、630からの信号は、同時にサンプリングされなくてもよい。A/D ISRは、マイクロホン626、630を繰り返し、マイクロホン626、630のそれぞれに対する波長について合計N個のサンプルを取る。結果は、
(二次および高次モデル)
容量センサチャンバ620のシール(例えば、シールアセンブリ1404)を通る漏出は、外部容量(例えば、外部容量1506、図23)に接続される第2の共振ポート(例えば、ポート1504、図23)としてモデル化され得る。
上記で導出される、容量センサアセンブリ148の方程式は、圧力が音響容量中のいずれの場所においても同じであると仮定する。容量を通る音波の伝搬と関連する時間遅延があるため、これは近似式にすぎない。この状況は、マイクロホンおよびスピーカの相対位置に基づく、時間遅延または時間前進のように見える場合がある。
容量センサアセンブリ148はまた、別個の共振ポート(例えば、ポート1510、図26)に接続される第3の参照容量(例えば、参照容量1508、図26)を使用して、構成されてもよい。この構成は、温度非依存性容量推定を可能にし得る。
流動抵抗を通る流出が、以下の形態であると仮定する。
モデル適合は、ポートの共振周波数が正弦波掃引データから抽出されることを可能にする。次のステップは、この値を送達容量に関連付けることである。共振周波数と送達容量との間の理想的な関係は、以下のように表される。
(末端効果)
ポート(例えば、ポートアセンブリ624)の中で共振する空気は、各振動の終わりにおいて、音響容量の中まで延在し得る。空気が延在する距離は、基本容量センサアセンブリ方程式に基づいて推定され得る。所与の音響容量について、空気が容量の中へ延在する距離は、圧力およびポート断面積の関数として表され得る。
V1(例えば、固定容量1500)のサイズ決定は、極の相対位置および伝達関数におけるゼロとの、音響容量のトレードオフを必要とし得る。V1およびV2(例えば、可変容量1502)の両方の伝達関数を、スピーカアセンブリ622の容量変位に対して以下に示す。
・スピーカアセンブリ622が、固定容量1500内で時間変動圧力を生成してもよい。・共振塊(図示せず)が、時間変動電圧/電流に反応する圧電材料であってもよい。
・共振塊(図示せず)が、時間変動電圧/電流に反応する音声コイルであってもよい。
・固定容量中の圧力を測定する。
・共振塊(図示せず)が、圧電材料であってもよい。
・ひずみゲージが、ダイヤフラム(図示せず)、または共振塊(図示せず)を支持する他の構造部材に接続されてもよい。
・圧電センサを介する。
・容量センサを介する。
・光学センサを介する。
・ホール効果センサを介する。
・電位差計(時間変動インピーダンス)センサを介する。
・誘導型センサを介する。
・線形可変差動変圧器(LVDT)を介する。
例示的実施形態において、図50および図46を参照すると、SRRアンテナ2508の1つの用途は、ユーザ/患者2524に流体薬剤を送達することが可能な装着型注入装置2514への統合であってもよい。そのような用途において、ユーザ/患者の安全性は、これらの電気構成要素間の流体動作に依存し、したがって、制御ユニット2522を往復する確実な無線伝送が大いに重要である。
Claims (14)
- 医療的状態の少なくとも部分的な閉ループ制御のための方法であって、該方法は、
時間枠または事象中のグルコースデータを受信することと、
該グルコースデータを以前の同様の時間枠または事象と比較することと、
該時間枠または該事象中の予期しない結果を決定することと、
予期しない結果を示すために警告信号を送信することと
を含む、方法。 - 前記警告信号を送信することは、前記予期しない結果についてユーザに警告することを含む、請求項1に記載の方法。
- 前記予期しない結果に関する情報を入力するように前記ユーザを促すことをさらに含む、請求項2に記載の方法。
- 前記システムは、前記ユーザから前記予期しない結果に関する情報を受信せず、該システムをシャットダウンすることをさらに含む、請求項3に記載の方法。
- 前記システムをシャットダウンすることは、一連のアラームを介して、該シャットダウンについて前記ユーザに警告することを含む、請求項4に記載の方法。
- 一連のアラームを介して、前記シャットダウンについて前記ユーザに警告することは、一連の増大するアラームを介して、該シャットダウンについて該ユーザに警告することを含む、請求項5に記載の方法。
- 医療的状態の少なくとも部分的な閉ループ制御のための方法であって、該方法は、
時間枠または事象中の医療用流体送達データを受信することと、
該医療用流体送達データを以前の同様の時間枠または事象と比較することと、
該時間枠または該事象中の予期しない結果を決定することと、
予期しない結果を示すために警告信号を送信することと
を含む、方法。 - 警告信号を送信することは、前記予期しない結果についてユーザに警告することを含む、請求項7に記載の方法。
- 前記予期しない結果に関する情報を入力するように前記ユーザを促すことをさらに含む、請求項8に記載の方法。
- 前記システムは、前記ユーザから前記予期しない結果に関する情報を受信せず、該システムをシャットダウンすることをさらに含む、請求項9に記載の方法。
- 前記システムをシャットダウンすることは、一連のアラームを介して、該シャットダウンについて前記ユーザに警告することを含む、請求項10に記載の方法。
- 一連のアラームを介して、前記シャットダウンについて前記ユーザに警告することは、一連の増大するアラームを介して、該シャットダウンについて該ユーザに警告することを含む、請求項11に記載の方法。
- 検体センサの完全性を監視するための方法であって、該方法は、
検体に対する連続的検体センサにごく近接して、所定の濃度を有する該検体の体積を注射することと、
該連続的検体センサからデータを受信することと、
該検体センサが該検体の注射体積に応答するか否かを決定するために、該データを分析することと
を含む、方法。 - 前記検体は、グルコースである、請求項13に記載の方法。
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