JP5349053B2 - 薬物保存および分配装置、ならびにそれらを含むシステム - Google Patents
薬物保存および分配装置、ならびにそれらを含むシステム Download PDFInfo
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- JP5349053B2 JP5349053B2 JP2008549610A JP2008549610A JP5349053B2 JP 5349053 B2 JP5349053 B2 JP 5349053B2 JP 2008549610 A JP2008549610 A JP 2008549610A JP 2008549610 A JP2008549610 A JP 2008549610A JP 5349053 B2 JP5349053 B2 JP 5349053B2
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Description
本願は、2006年1月6日に出願された米国仮特許出願第60/756,937号の優先権の利益を請求し、その開示はその全体が本明細書中に参考として援用される。
本発明は、薬物投与形態の投与のための分配装置、およびそれらを含むシステムに関する。さらに本発明は、患者の身元を検出するための手段、ロックアウト特徴、および保存された薬剤への許可されていないアクセスを防止するための手段を提供する分配装置を含む。
現在、投与の経路、調合物、および投与管理を含め、入院患者および外来患者の両方における反復される薬物の治療的投与のための標準的な医療装置は、効能および毒性の両方に関して、明らかな限界を有している。
本発明は、患者へ薬物投与形態を分配するための分配装置であって、一度に複数の用量、単独の用量を分配するための手段を有する装置を提供する。
以下の開示は、本発明を構成する分配装置、システム、および方法を説明する。本明細書において、薬物を投与するための本発明の装置、システム、および方法について、詳細な開示が以下に提示される。本発明は、概して、(1)薬物分配装置、(2)薬物分配装置および薬物投与形態を含むシステム、ならびに(3)分配装置およびシステムを動作させるための方法を包含する。
本明細書において使用されるとき、用語「調合物」および「薬物調合物」あるいは「薬物投与形態」は、対象へと届けるためにいくつかある投薬形態にて提供されうる少なくとも1つの治療薬を含んでいる物質的な組成物を指す。投薬形態を、薬用舐剤、錠剤、カプセル、膜、ストリップ、液体、パッチ、フィルム、ガム、ゲル、スプレー、または他の形態として、患者へと提供することができる。
院外の急性の状況
分配装置の例示的な1つの用途は、治療効果を迅速に生み出し、安全かつ便利に使用することができ、適切な時間期間にわたって治療効果をもたらす迅速作用の投与形態を提供することにある。本発明の分配装置を、院外の状況において使用することが可能である。院外の状況において、本発明の分配装置の一実施形態は、以下の構造的および機能的特徴を呈することができる。すなわち、分配装置は、単独の可搬性様式であってよい。分配装置は、数週間にものぼる治療が可能であってよい。分配装置は、使い捨てかつ/または再充填不可能であってよい。分配装置は、子供にとって操作できないものであってよい。分配装置は、投薬の間の固定のロックアウトを有してよい。分配装置は、固定の時間期間の後に停止を呈することができる。分配装置は、分配ボタン、音または音色、ならびにLEDに限定されたインターフェイスを有することができる。分配装置は、温度を監視することができ、薬物投与が安全限界を超える場合に停止することができる。ディスプレイ。分配装置は、用量カウンタを備えることができる。
本発明の分配装置の他の使用は、院内の状況において生じる。例えば、急性痛の迅速な治療の必要性が、術後の回復、関節リウマチ、術後腰下肢痛(failed back)、末期がん、など、病院の状況における多数のさまざまな臨床の状況において生じる。例えば、術後に患者は、最初の数日にわたって深刻な痛みに苦しみ、その後に軽度から中程度レベルの痛みの日々が続く。
本発明の分配装置のさらに別の実施形態は、慢性症状を抱える患者のために慢性投与が必要である院外の状況にある。
費用効果的であり、誤りの危険を最小にし、偶発的および意図的な誤用および転用に抗し、薬剤を取り扱う必要性をなくし、かつ労働集約的でないやり方で、所与の薬剤を正しい患者へと正確に分配することができる薬物分配装置について、未だ満たされていない要望が絶えず存在している。
本発明の分配装置の所望の使用が完了し、分配装置がもはや必要とされないとき、完全に使い捨てることができ、一部を使い捨てて一部を再使用することができるか、あるいは全体を再使用することができる。1つの例示的な適用においては、分配装置を用いて、舌下錠剤を患者の舌の下方に配置することができ、したがって、投薬の間に安全なロックアウト期間が経過するまで患者の自己投与での次の舌下錠剤の投与をロックする手段、投薬履歴を記録する手段、およびこの履歴をユーザ、コンピュータ、別の電子装置、またはネットワークへと通信する手段を与えることができる。
図8Aは、小容量経口経粘膜薬物投与形態を送達するための分配装置100の例示的な分配機構の概略図であり、カラム方分配機構が休止位置にある。分配機構が、1つ以上のカートリッジアセンブリ102、作動ボタン104、モータ106、カム108、乾燥剤110、1つ以上のシール112、送達センサ114、ばねクリップ116、およびばね118を含んでいる。本発明の分配装置100は、積層にもとづいた投与形態あるいは管状のカートリッジまたはマガジン102に収容された複数の投与形態48の分配をもたらし、ばね120が一端に位置して投与形態のスタックへと装填力を加えている。図8Bは、図8Aの分配装置の概略図であり、分配機構、モータ、およびカムの位置は、休止位置にある。アセンブリ102および投与形態のスタック48が、投与形態のスタック48の軸に対して直角に可動性スライダ124に当接している。スライダ124は、単一の投与形態の投与形態のスタックの軸上での厚さ以下の厚さを有する薄いブレードである。スライダ124は、ばね120がスタックを押すことによって最初の投与量48がスライダ124の反対側の固体面に対して配置されるように、投与形態カートリッジ102の端部と固体面との間をスライドする。スライダ124は、最初の投与量48を受け入れるように寸法付けられた収容部128をカムの反対側に備えている。典型的なカートリッジ分配機構として、カラム型、リボン/テープ型、ディスク型、らせん型、バレル型、インデックス/ばね荷重型、ホッパー型、コンベア型、連続錠剤型、シュリンクラップ型、スナップアウト型、トラック型、バレルロック型、接着テープ、ポケットテープ型、単一用量アプリケータ、またはスタック付きフォイル型が挙げられる。
本発明の薬物分配装置を使用して患者へと投与形態を投与するためのシステムは、薬物分配装置、薬物投与形態、および患者を含む。システムに含まれることができるさらなる特徴は、ドッキングステーションまたは他のドッキング手段、現場または遠方のコンピュータシステムとの双方向通信リンク(有線または無線)などのコンピュータネットワークとの通信手段、装置を監視および制御する薬剤ネットワーク、装置からの薬物の送達についての情報を保存、記録、および伝達するコンピュータネットワーク、ならびに1つ以上のユーザインターフェイスである。
経口経粘膜の薬物送入は、効果的であり、送達が容易であり、非侵襲性であり、最小限の不快にて介護士または患者によって投与することができる。一般に、調合薬の経口経粘膜の送達は、舐剤などの固形の投与形態または投与形態を使用して達成されるが、液体、スプレー、ゲル、粉末、ガム、発泡体、パッチ、およびフィルムも、使用可能である。本発明の薬物分配装置は、口腔粘膜経由の薬物の送達に適合された小容量薬物投与形態を送達するための手段を提供する。
本発明の薬物分配装置に適合する投与形態にて投与できる任意の薬物を、本発明の方法およびシステムにおいて使用することができる。
単一の投与形態の送達を、本発明の薬物分配装置を使用して、以下に説明される図に詳述されるとおりに達成できる。
医師が、患者が急性痛の管理の治療を必要としていると判断する。薬剤師が、所望の強度の投与形態を含んでいるカートリッジを薬物分配装置に装填する。それぞれのカートリッジは、分配される最初の2つの投与形態となるように配置された2色の偽薬投与形態を有している。装置は、安全であって許可されていないユーザがアクセスすることができないポート、ハッチ、または扉であるカートリッジを装填するための手段を有している。薬剤師は、ひとたびカートリッジを装置へと装填すると、装置のアクセスポート、ハッチ、または扉をロックする。次いで、薬剤師は、分配装置をパーソナルまたは他のコンピュータへと接続されたドックへとドッキングコネクタを使用して初めてドッキングさせ、装置をプログラムする。プログラミングは、投与形態の投与強度、装置内に装填された投与形態の数、処方による投与形態の使用頻度、1日当たりに使用すべき投与形態の数、現在の日付および時刻、好ましい言語、患者を識別するための有効な拇印または他の身分証明になるもの、ならびに装置が失われて発見された場合の医師の識別情報のアップロードを含む。
患者がより直接的な監督のもとにある病院の状況においては、薬物分配装置のアクセスおよび識別は、RFIDキーの検出のみに限定され、拇印またはPINの提示は要求されない。術後または他の理由で不自由である患者が、過度な身体活動を必要とせずに装置を動作させることができる。あるいは、付き添いの看護士または医師が、患者へと用量を分配することができる。RFIDキーを使用することで、装置が偶発的または意図的に別の患者と入れ替わる可能性が防止される。
Claims (15)
- 被験体へ個々の小容量錠剤を舌下投与するための分配装置であって、
(a)複数の個々の錠剤を含むカートリッジ;
(b)被験体の舌下領域に該複数の錠剤のうちの第1の錠剤を分配するための分配端を有するハウジングであって、該分配端は、該第1の錠剤が通過させられることが可能な送達経路の少なくとも一部分を規定し、該送達経路の少なくとも一部分は、該ハウジングの中への水分の進入を抑制するように構成された非直線形状を有する、ハウジング;
(c)該第1の錠剤が分配された後に、所定のロックアウト期間の間に、第2の錠剤の分配を防止するように構成されたロックアウト特徴;および
(d)押し棒であって、該押し棒の少なくとも一部分は、該送達経路内に移動可能に配置され、該押し棒は、該押し棒が該送達経路内を移動させられる場合に、該送達経路の非直線形状をとるように十分に可撓性である、押し棒
を備える、分配装置。 - 前記分配端が、シール、ワイパー、吸収剤、吸着剤、乾燥剤、およびエアギャップのうちの1つ以上を備える、前記第1の錠剤の舌下投与の間に前記送達経路の中への唾液の進入を防止するかまたは遅らせる手段を備える、請求項1に記載の分配装置。
- 前記所定のロックアウト期間が、あらかじめプログラムされている、請求項1または2に記載の分配装置。
- 前記所定のロックアウト期間が、固定の時間間隔、所定の時間間隔、所定の可変の時間間隔、アルゴリズムによって決定される時間間隔、または、遠隔コンピュータから前記装置に通信される可変の時間間隔のうちの少なくとも1つである、請求項1〜3のいずれか1項に記載の分配装置。
- 前記第1の錠剤がスフェンタニルを含む、請求項1〜3のいずれか1項に記載の分配装置。
- 分配カートリッジは、前記カートリッジ上の物理的なキーの特徴(physical keyed feature)、該カートリッジ上のバーコード、該カートリッジ上の磁気タグ、該カートリッジ上の無線識別(RFID)タグ、該カートリッジ上の電子マイクロチップ、またはこれらの組み合わせのうちの少なくとも1つを含むカートリッジ認識システムを含む、請求項1に記載の分配装置。
- 患者識別手段をさらに備え、該患者識別手段は、指紋読み取り器、光学網膜読み取り器、音声認識、無線識別(RFID)読み取り器、Wi−Fi、またはこれらの組み合わせのうちの少なくとも1つを含む、請求項1に記載の分配装置。
- 前記患者識別手段が、識別される被験体の一致するRFIDタグと結び付けられるように構成されたRFID読み取り器である、請求項7に記載の分配装置。
- (a)前記分配装置の前記RFID読み取り器が前記被験体の前記一致するRFIDタグを検出する場合、および(b)前記所定のロックアウト期間が経過した場合に、該分配装置のロックが解除される、請求項8に記載の分配装置。
- 前記押し棒は、該押し棒の端部が該送達経路内にある第1の位置と、該端部が前記ハウジングの前記分配端において該送達経路の出口ポートから延びている第2の位置との間で、該送達経路内で移動可能である、請求項1に記載の分配装置。
- 前記ロックアウト特徴は、前記押し棒の、その第1の位置からその第2の位置までの移動を抑制するように構成されている、請求項10に記載の分配装置。
- 前記出口ポートをカバーするように配置されたシールをさらに備え、
前記押し棒は、該押し棒がその第2の位置にある場合に、該シールを通って延びるように構成されている、請求項10に記載の分配装置。 - 前記ハウジングの前記分配端は、前記シールの少なくとも一部分の周囲に、および、該シールから離れて配置された分配チップを含み、
該分配チップは、前記出口ポートが、前記第1の錠剤を分配するために、前記被験体の口内にある場合に、該被験体の口が該シールと係合することを防止するように構成されている、請求項12に記載の分配装置。 - 疼痛の処置において使用するための、請求項1〜13のいずれか1項に記載の分配装置。
- 前記疼痛が急性痛、術後痛、または突出痛である、請求項14に記載の分配装置。
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PCT/US2007/000527 WO2007081947A2 (en) | 2006-01-06 | 2007-01-08 | Drug storage and dispensing devices and systems comprising the same |
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WO2007081947A2 (en) | 2007-07-19 |
US8905964B2 (en) | 2014-12-09 |
US8357114B2 (en) | 2013-01-22 |
EP1973593B1 (en) | 2013-04-10 |
JP2009526553A (ja) | 2009-07-23 |
US20130131586A1 (en) | 2013-05-23 |
CA2636115C (en) | 2014-06-03 |
US20070186923A1 (en) | 2007-08-16 |
EP2612645B1 (en) | 2020-03-18 |
CA2848274A1 (en) | 2007-07-19 |
EP1973593A4 (en) | 2011-05-04 |
KR20080090505A (ko) | 2008-10-08 |
DK2612645T3 (da) | 2020-04-06 |
CA2636115A1 (en) | 2007-07-19 |
KR101354872B1 (ko) | 2014-02-18 |
WO2007081947A3 (en) | 2009-04-02 |
CA2848274C (en) | 2016-09-20 |
EP2612645A3 (en) | 2014-03-12 |
EP3730120A1 (en) | 2020-10-28 |
CN103585021A (zh) | 2014-02-19 |
EP1973593A2 (en) | 2008-10-01 |
EP2612645A2 (en) | 2013-07-10 |
ES2408323T3 (es) | 2013-06-20 |
ES2785300T3 (es) | 2020-10-06 |
PT2612645T (pt) | 2020-09-17 |
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