JP2016535607A - 知的制御を有する薬剤送達ポンプ - Google Patents
知的制御を有する薬剤送達ポンプ Download PDFInfo
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Abstract
Description
本願は、2013年9月24日に出願された、米国出願第14/035,702号および第14/035,835号に対する優先権および利益を主張するものであり、その開示の全体は、参照により本明細書中に援用される。
図1は、本発明の種々の実施形態による、薬剤ポンプデバイス100の主要な機能的構成要素をブロック図形態で図示する。一般に、ポンプデバイス100は、変位可能部材106を介して電解ポンプ104と連動する薬剤貯留部102を含む。変位可能部材106は、例えば、ピストン、ダイヤフラム、ブラダ、またはプランジャであってもよい。使用中に、薬剤貯留部102は、液体形態の薬剤で充填され、ポンプ104によって生成される圧力は、貯留部102から液体薬剤を押し出すよう、変位可能部材106を移動させるか、または拡張する。薬剤貯留部102の出口に接続されるカニューレ、針、または他の出口部材108は、液体を注入セット109へ伝導する。注入セット109は、薬剤を皮下組織領域に送達するためにカニューレ108に流体的に接続されるカテーテルを含んでもよい。ランセットおよび関連挿入機構が、皮膚を通してカテーテルを駆動するために使用されてもよい。代替として、注入セット109は、別の種類の薬剤送達媒介物、例えば、皮膚表面を通した薬剤吸収を促進するスポンジまたは他の手段を含んでもよい。
本明細書による閉ループフィードバック制御は、駆動式ポンプ内の正確な薬剤送達を確実にする。ある送達方式では、ポンプシステムは、薬剤を離散用量またはパルスとして送達し、ポンプの連続送達能力をはるかに下回る流動率をもたらす。そのような低流動率におけるプランジャおよびカートリッジのガラス壁の吸着に及ぼす影響に起因して、薬剤の各小離散用量は、プランジャが吸着力を克服するように押動された後に発生される。各離散送達は、標的流動率より高い流動率まで超過された後、プランジャ移動の急停止が続き、流動率を、ある間隔の間、中止させてもよい。これらの反復交互パルスおよび非送達周期の組み合わせは、理論上、標的流動率に等しい平均流動率と、連続送達モードから得られる体積に等しい用量体積の量とをもたらす。本アプローチは、パルス毎のピーク流動率が、500nL/分、パルス毎の持続時間が、4分、連続一定送達モードを表す平均流動率が、33.3nL/分である、離散用量モードを示す、図3に図示される。
Claims (31)
- 薬剤ポンプデバイスであって、
薬剤貯留部と、
前記貯留部を薬剤注射部位と流体的に接続するための出口部材と、
センサと、
介在変位部材を介して前記薬剤貯留部と機械的に連通しているポンプチャンバを備える、電解ポンプであって、圧力を付与して、前記出口部材に向かって前記変位部材を駆動し、それによって、それを通して前記薬剤チャンバ内の流体を押勢するように動作可能である、電解ポンプと、
(i)1つまたはそれを上回る送達パラメータおよびそのための標的値を記憶し、(ii)プライミング段階において、前記電解ポンプを動作させ、前記薬剤貯留部から前記出口部材の中に、但し、実質的に、任意の流体を前記出口部材から流出させずに、流体の体積を押勢し、(iii)前記センサから受信された信号に基づいて、1つまたはそれを上回る送達パラメータの標的値とその測定された値との間の逸脱を判定し、(iv)少なくとも部分的に、前記判定された逸脱に基づいて、送達段階において、前記ポンプを動作させ、前記薬剤貯留部から前記出口部材を通して前記流体の標的体積を押勢するための制御回路と
を備える、デバイス。 - 前記センサは、少なくとも1つの圧力センサである、請求項1に記載のデバイス。
- 前記センサは、少なくとも1つの流量センサである、請求項1に記載のデバイス。
- 前記センサは、少なくとも1つの流量センサおよび少なくとも1つの圧力センサを備える、請求項1に記載のデバイス。
- 前記1つまたはそれを上回る送達パラメータは、流動体積または流動率のうちの少なくとも1つである、請求項1に記載のデバイス。
- 前記測定された値は、直接または間接的に、前記センサ信号から得られる、請求項1に記載のデバイス。
- 前記電解ポンプは、圧送が開始するポンプ開始時間と、前記ポンプがシャットオフされるポンプ停止時間とによって定義される時間窓を有するパルスとして、前記薬剤貯留部から前記出口部材の中に流体を押勢するように動作可能であり、前記時間窓は、前記予期される流動率における前記標的送達体積に対応し、前記制御回路は、前記薬剤貯留部から前記出口部材を通して前記流体の標的体積を押勢するために、少なくとも部分的に、前記判定された逸脱に基づいて、前記パルスを調節する、請求項1に記載のデバイス。
- 少なくとも1つのパルスは、非治療用用量に対応する、請求項7に記載のデバイス。
- 前記1つまたはそれを上回る送達パラメータは、流動体積であり、前記流動体積は、前記パルスの間に排出されるパルス体積と、前記パルス後に排出される付加的追随量体積とを含み、前記パルス調節は、前記測定されたパルス体積および追随量体積に基づく、請求項7に記載のデバイス。
- 前記制御回路は、前記送達段階の間、単一のボーラスの送達を生じさせる、請求項1に記載のデバイス。
- 前記標的送達体積は、ある時間間隔にかけて生じる時間的に分離されたパルスのシーケンスにわたって、前記出口部材を通して分注される、請求項1に記載のデバイス。
- 薬剤貯留部と、前記貯留部を薬剤注射部位と流体的に接続するための出口部材と、圧力を付与し、前記変位部材を前記出口部材に向かって駆動させ、それによって、それを通して前記薬剤チャンバ内の流体を押勢するように動作可能な電解ポンプとを備える、薬剤ポンプデバイスにおいて、流体の実際の送達体積を標的送達体積に一致させるように制御する方法であって、
プライミング段階において、前記電解ポンプを動作させ、前記薬剤貯留部から前記出口部材の中に、但し、実質的に、任意の流体を前記出口部材から流出させずに、流体を押勢するステップと、
前記プライミング段階の間、1つまたはそれを上回る送達パラメータの予期される値とその測定された値との間の逸脱を判定するステップと、
少なくとも部分的に、前記判定された逸脱に基づいて、送達段階において、前記ポンプを動作させ、前記薬剤貯留部から前記出口部材を通して前記流体の標的体積を押勢するステップと
を含む、方法。 - 前記1つまたはそれを上回る送達パラメータは、流動体積または流動率のうちの少なくとも1つである、請求項12に記載の方法。
- 流体は、圧送が開始するポンプ開始時間と、前記ポンプがシャットオフされるポンプ停止時間とによって定義される時間窓を有するパルスとして、前記薬剤貯留部から前記出口部材の中に押勢され、前記時間窓は、前記予期される流動率における前記標的送達体積に対応し、前記ポンプは、前記流体の標的体積を前記薬剤貯留部から前記出口部材を通して押勢するために、少なくとも部分的に、前記判定された逸脱に基づいて、前記送達段階中の調節されたパルス時間の間、動作される、請求項12に記載の方法。
- 前記1つまたはそれを上回る送達パラメータは、流動体積であり、前記流動体積は、前記パルスの間に排出されるパルス体積と、前記パルス後に排出される付加的追随量体積とを含み、前記調節されたパルス時間は、前記測定されたパルス体積および追随量体積に基づく、請求項13に記載の方法。
- 単一のボーラスが、前記送達段階の間、排出される、請求項12に記載の方法。
- 前記標的送達体積は、ある時間間隔にかけて生じる時間的に分離されたパルスのシーケンスにわたって、前記出口部材を通して分注される、請求項12に記載の方法。
- 少なくとも1つのパルスは、非治療用用量に対応する、請求項14に記載の方法。
- 薬剤ポンプデバイスであって、
薬剤貯留部と、
前記貯留部を薬剤注射部位と流体的に接続するための出口部材と、
センサと、
介在変位部材を介して前記薬剤貯留部と機械的に連通しているポンプチャンバを備える、電解ポンプであって、圧力を付与して、前記出口部材に向かって前記変位部材を駆動し、それによって、それを通して前記薬剤チャンバ内の流体を押勢するように動作可能である、電解ポンプと、
(i)規定された時間にかけて、標的送達体積を貯蔵し、(ii)前記電解ポンプを動作させ、圧送が開始するポンプ開始時間と、前記ポンプがシャットオフされるポンプ停止時間とによって定義される時間窓を有するパルスとして、前記薬剤貯留部から前記出口部材の中に流体を押勢し、前記時間窓は、所定の流動率における前記標的送達体積に対応し、(iii)前記センサから受信された信号に基づいて、パルスから生じる前記出口部材を通る流体の体積を測定し、前記測定された体積は、前記パルスの間に前記出口部材を通るパルス体積と、前記パルス後に前記出口部材を通る付加的追随量体積とを含み、(iv)前記測定されたパルス体積および追随量体積に基づいて、前記パルス時間窓を調節し、集合的に、前記標的送達体積に一致させるための制御回路と
を備える、デバイス。 - 前記センサは、少なくとも1つの圧力センサである、請求項19に記載のデバイス。
- 前記センサは、少なくとも1つの流量センサである、請求項19に記載のデバイス。
- 前記センサは、少なくとも1つの流量センサおよび少なくとも1つの圧力センサを備える、請求項19に記載のデバイス。
- 前記標的送達体積は、単一のボーラスに対応し、前記制御回路は、プライミング段階の間、測定を生じさせ、送達段階の間、調節を生じさせる、請求項19に記載のデバイス。
- 前記制御回路は、ある時間間隔にかけて生じる時間的に分離されたパルスのシーケンスにわたって、前記標的送達体積を前記出口部材を通して分注させ、前記制御回路は、第1の時間間隔の間、測定を生じさせ、前記第1の時間間隔に続く第2の時間間隔の間、調節を生じさせる、請求項19に記載のデバイス。
- 前記調節は、複数のパルスからの測定されたパルス体積および追随量体積に基づく、請求項24に記載のデバイス。
- 薬剤貯留部と、前記貯留部を薬剤注射部位と流体的に接続するための出口部材と、前記薬剤貯留部から前記出口部材の中に、それぞれ、ポンプが開始するポンプ開始時間と、前記ポンプがシャットオフされるポンプ停止時間とによって定義される時間窓を有する、パルスとして、流体を押勢するように動作可能な電解ポンプとを備え、前記時間窓は、所定の流動率における標的送達体積に対応する、薬剤ポンプデバイスにおいて、流体の実際の送達体積を標的送達体積に一致させるように制御する方法であって、
パルスから生じる前記出口部材を通る流体の体積を測定するステップであって、前記測定された体積は、(i)前記パルスの間に前記出口部材を通るパルス体積と、(ii)前記パルス後に前記出口部材を通る付加的追随量体積とを含む、ステップと、
前記測定されたパルス体積および追随量体積に基づいて、前記パルス時間窓を調節し、集合的に、前記標的送達体積に一致させるステップと
を含む、方法。 - 前記測定は、少なくとも1つの圧力センサを用いて行われる、請求項26に記載の方法。
- 前記センサは、少なくとも1つの流量センサである、請求項26に記載の方法。
- 前記標的送達体積は、単一のボーラスに対応し、前記調節ステップは、プライミング段階の間に生じ、前記調節ステップは、送達段階の間に生じる、請求項26に記載の方法。
- 前記標的送達体積は、ある時間間隔にかけて生じる時間的に分離されたパルスのシーケンスにわたって、前記出口部材を通して分注され、前記測定ステップは、第1の時間間隔の間に生じ、前記調節ステップは、前記第1の時間間隔に続く第2の時間間隔の間に生じる、請求項26に記載の方法。
- 前記調節ステップは、複数のパルスからの測定されたパルス体積および追随量体積に基づく、請求項30に記載の方法。
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US9849238B2 (en) | 2017-12-26 |
US20140094770A1 (en) | 2014-04-03 |
WO2015048093A2 (en) | 2015-04-02 |
EP3049129A2 (en) | 2016-08-03 |
US20140094771A1 (en) | 2014-04-03 |
US9333297B2 (en) | 2016-05-10 |
WO2015048093A3 (en) | 2015-06-18 |
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