JP2005525873A - 鎮静および鎮痛システムの無菌操作を可能にするシステムおよび方法 - Google Patents
鎮静および鎮痛システムの無菌操作を可能にするシステムおよび方法 Download PDFInfo
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Abstract
Description
発明の分野
本発明は、包括的には医療システムの無菌操作に関し、特に、鎮静および鎮痛システムの無菌操作に関する。
本願は、米国特許法第119条(e)項に基づき、2002年5月16日付で出願された米国仮特許出願第60/378,045号明細書「System and Method for Permitting Sterile Operation of a Sedation and Analgesia System」(参照により本明細書中に援用される)の優先権を主張する。
痛みを伴う、不快なあるいは怖い(不安をかき立てる)医療または外科的処置を受ける患者に、鎮静、鎮痛、および/または記憶消失(amnestic)薬を安全に、免許を受けた麻酔担当者(anesthesia provider)がいるか否かに関わらず過剰投薬の危険性を減らす方法で受け取る手段を供給するために鎮静および鎮痛システムが開発されてきた。技術の大きな発展を利用して、鎮静および鎮痛システムは、病院および外来環境で安全に使用されるように設計されてきており、例えば有資格の麻酔看護婦(certified registered nurse anesthetist)(CRNA)、麻酔助手、訓練を受けた医師、または他の訓練を受けたオペレータといった訓練を受けた麻酔科医以外の個人が操作することができる。鎮静および鎮痛システムは、安全で効果的な鎮静および鎮痛が恐れや痛みの作用を実質的に軽減できる全ての処置に麻酔担当者の予定を組むことができない開業医の要求に応えるところまできた。これらの目的を専用とする鎮静および鎮痛システムの出現が、これらの個人に、麻酔機器の操作に必要な認知的および手作業の負担を減らしながら、尚も臨床医が常に患者管理を支配することを可能にする患者モニタリングシステムと一体化された薬剤送出(drug delivery)システムを提供する。臨床医は、「臨床医が最も良く知っている」という方針に則って最終的な意思決定責任を持ち続ける。この技術の進化により、鎮静および鎮痛システムを、麻酔担当者がいなくても全身麻酔未満の薬剤レベル効果で操作することが可能になり、費用に対し効果の高い、容易に利用できる鎮静、記憶消失(amnesia)、および/または鎮痛手段を患者に提供することができる。
本発明は、無菌領域において、無菌領域(sterile area)を汚染したり無菌状態(aseptic condition)を壊したりせずに、鎮静および鎮痛システムを操作することを可能にする鎮静および鎮痛システムのためのデバイスおよび方法を提供することによって、上述の自動薬剤注入デバイスの欠点を解決する。本発明を用いれば、医療処置に参加している臨床医でさえも、無菌領域、操作している臨床医自身、あるいは患者を汚染せずに、鎮静および鎮痛システムをユーザインタフェースにより操作することができる。
図1は、ユーザインタフェース12、ソフトウェア制御のコントローラ14、周辺機器15、電源16、外部通信10、リモート出力11、患者インタフェース17、および薬剤送出部(drug delivery)19を有する鎮静および鎮痛システム22を含む本発明の1実施形態を示すブロック図を示し、鎮静および鎮痛システム22はユーザ13によって、患者18に鎮静および/または鎮痛をもたらすように操作される。鎮静および鎮痛システム22は、1999年6月3日付で出願された同一出願人に譲渡される(commonly assigned)同時係属中の米国特許出願第09/324,759号明細書(その全体が参照により本明細書中に援用される)において開示され実施可能にされている。ユーザインタフェース12の実施形態は、2002年11月1日付で出願された同一出願人に譲渡された同時係属中の米国特許出願第10/285,689号明細書(その全体が参照により本明細書中に援用される)において開示され実現可能にされている。
Claims (35)
- 患者に結合されて、前記患者の少なくとも1つの生理的状態を反映する信号を生成するようになっている患者健康モニタデバイスと、
ユーザが入力を行うことを可能にするユーザインタフェースであって、前記入力は、無菌状態を壊さずに行われる、ユーザインタフェースと、
1つまたは複数の薬剤を前記患者に供給する薬剤送出コントローラと、
少なくとも1つのモニタされる患者の生理的状態の安全なおよび望ましくないパラメータを反映する安全データセットを格納するメモリデバイスと、
前記患者健康モニタ、前記薬剤送出コントローラ、および前記安全データセットを格納する前記メモリデバイス間で相互接続される電子コントローラであって、前記信号を受信し、それに応答して、前記安全データセットに従って前記薬剤の投与を管理する、電子コントローラと
を備える鎮静および鎮痛システム。 - 前記ユーザインタフェースは、無菌領域において医療処置を行っている臨床医によって使用される請求項1に記載の鎮静および鎮痛システム。
- 前記ユーザインタフェースは無菌ユーザインタフェースである請求項1に記載の鎮静および鎮痛システム。
- 前記ユーザインタフェースは耐汚染性である請求項3に記載の鎮静および鎮痛システム。
- 前記無菌ユーザインタフェースは、モニタ、モニタスクリーン、キーパッド、およびキーパッドスクリーンを備え、
前記スクリーンはそれぞれ、前記ユーザインタフェースの操作中に通常接触される表面を覆う
請求項3に記載の鎮静および鎮痛システム。 - 前記スクリーンの少なくとも一部は透明である請求項5に記載の鎮静および鎮痛システム。
- 前記スクリーンは、ポリエチレンおよびポリプロピレンのうちの少なくとも1つで作られる請求項6に記載の鎮静および鎮痛システム。
- 前記スクリーンの少なくとも一部は半透明である請求項5に記載の鎮静および鎮痛システム。
- 前記スクリーンは、ポリエチレンおよびポリプロピレンのうちの少なくとも1つで作られる請求項8に記載の鎮静および鎮痛システム。
- 前記スクリーンはそれぞれ別個の縁を備え、
前記縁はそれぞれ、前記スクリーンよりも硬く、前記スクリーンを所定の向きで支持するようになっている
請求項5に記載の鎮静および鎮痛システム。 - 前記モニタスクリーンおよび前記キーパッドスクリーンは1つの連続した無菌スクリーンを構成する請求項5に記載の鎮静および鎮痛システム。
- 前記無菌ユーザインタフェースを前記鎮静および鎮痛システムに取り外し可能に結合する接着面をさらに備える請求項5に記載の鎮静および鎮痛システム。
- 前記モニタスクリーンを前記モニタに、および前記キーパッドスクリーンを前記キーパッドに、取り外し可能に結合する接着面をさらに備える請求項5に記載の鎮静および鎮痛システム。
- 前記スクリーンは、医療処置の終了後に取り外されて廃棄される請求項13に記載の鎮静および鎮痛システム。
- 前記スクリーンは、前記スクリーンの洗浄を試みた場合に劣化する材料で作られる請求項14に記載の鎮静および鎮痛システム。
- 前記スクリーンは、医療処置の終了後に取り外されて再び殺菌される請求項13に記載の鎮静および鎮痛システム。
- 前記モニタスクリーンおよび前記キーパッドスクリーンは抗菌剤を含浸される請求項5に記載の鎮静および鎮痛システム。
- 前記ユーザインタフェースはリモートインタフェースおよび無菌スリーブを備える請求項1に記載の鎮静および鎮痛システム。
- 前記無菌スリーブは透明であり、周囲にシールを備えて内部にポケットを形成するようになっている請求項18に記載の鎮静および鎮痛システム。
- 前記リモートインタフェースは、警報コマンド、薬剤コマンド、statコマンド、およびデータ入力および操作コマンドのうちの少なくとも1つを備える請求項19に記載の鎮静および鎮痛システム。
- 前記スリーブは、医療処置の終了後に取り外されて廃棄される請求項19に記載の鎮静および鎮痛システム。
- 前記ユーザインタフェースは、前記鎮静および鎮痛システムの適切な部分を覆って、前記ユーザおよび前記患者に接触することによる汚染の可能性を防ぐようにすることができる無菌シートを備える請求項1に記載の鎮静および鎮痛システム。
- 前記無菌シートは、前記鎮静および鎮痛システムを完全に封入する請求項22に記載の鎮静および鎮痛システム。
- 鎮静および鎮痛システムを操作する方法であって、
1つまたは複数の薬剤を供給する薬剤送出コントローラを有する薬剤送出デバイスを患者に接続するステップであって、前記薬剤送出コントローラは、前記患者への前記薬剤の送出を制御する電子コントローラに結合される、接続するステップと、
少なくとも1つの患者健康モニタデバイスを患者に取り付けるステップであって、前記患者健康モニタデバイスは、患者の少なくとも1つの生理的状態を反映する値を生成するとともに、前記電子コントローラに結合される、取り付けるステップと、
前記鎮静および鎮痛システムのユーザインタフェースの少なくとも一部を無菌カバーで覆うステップと、
前記ユーザインタフェースおよび無菌カバーを介して前記鎮静および鎮痛システムを操作するステップと、
少なくとも1つの患者の生理的状態のパラメータを反映する安全データセットを格納するメモリデバイスにアクセスするステップと、
前記安全データセットに従って前記薬剤を前記患者に送出するステップと
を含む、鎮静および鎮痛システムを操作する方法。 - 前記ユーザインタフェースは、ユーザが前記ユーザインタフェースの操作中にそれぞれ通常接触するディスプレイおよびキーパッドを備える請求項24に記載の鎮静および鎮痛システムを操作する方法。
- 前記無菌カバーの少なくとも一部は透明である請求項25に記載の鎮静および鎮痛システムを操作する方法。
- 前記無菌カバーは、前記カバーを前記ユーザインタフェースに取り外し可能に結合する接着面を含む請求項25に記載の鎮静および鎮痛システムを操作する方法。
- 医療処置の終了後に前記無菌カバーを取り外して廃棄することをさらに含む請求項25に記載の鎮静および鎮痛システムを操作する方法。
- 前記無菌カバーは抗菌剤で含浸される請求項25に記載の鎮静および鎮痛システムを操作する方法。
- ユーザが、患者に対して行われる医療処置中に無菌領域を維持しながら、鎮静および鎮痛システムにアクセスする方法であって、
ユーザインタフェース、患者インタフェース、薬剤送出システム、および電源を有する鎮静および鎮痛システムを提供するステップと、
前記ユーザインタフェースを無菌スクリーンに包むステップであって、無菌領域における前記鎮静および鎮痛システムの使用を可能にするようにする、包むステップと、
前記鎮静および鎮痛システムを無菌領域において操作するステップと、
前記鎮静および鎮痛システムを伴う処置を終了するステップであって、前記患者インタフェースを取り外すことおよび前記薬剤送出システムを取り外すことを含む、終了するステップと、
前記無菌スクリーンを取り外すステップであって、前記ユーザが、前記鎮静および鎮痛システム、前記患者、および前記ユーザ自身をいずれも汚染しないようにする、取り外すステップと
を含む、鎮静および鎮痛システムにアクセスする方法。 - 前記ユーザインタフェースは、リモートインタフェース、LCDディスプレイ、キーパッド、または前記鎮静および鎮痛システムの閲覧および/または操作に適した他の手段のうちの1つである請求項30に記載の鎮静および鎮痛システムにアクセスする方法。
- 前記無菌スクリーンは、無菌ユーザインタフェース、無菌スリーブ、および無菌カバーのうちの少なくとも1つである請求項30に記載の鎮静および鎮痛システムにアクセスする方法。
- 前記鎮静および鎮痛システムに関連付けられた全ての特徴を覆うかまたは他の方法でそれが無菌であることを保証するステップをさらに含む請求項30に記載の鎮静および鎮痛システムにアクセスする方法。
- 前記無菌スクリーンを廃棄するステップをさらに含む請求項30に記載の鎮静および鎮痛システムにアクセスする方法。
- 前記無菌スクリーンを再び殺菌して、前記スクリーンを将来の使用に利用できるようにするステップをさらに含む請求項30に記載の鎮静および鎮痛システムにアクセスする方法。
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US20040034287A1 (en) | 2004-02-19 |
EP1531892A4 (en) | 2007-09-12 |
JP2010094541A (ja) | 2010-04-30 |
WO2003097111A3 (en) | 2004-09-16 |
MXPA04011420A (es) | 2005-02-17 |
CA2486123A1 (en) | 2003-11-27 |
AU2003241479A1 (en) | 2003-12-02 |
AU2003241479B2 (en) | 2008-08-28 |
WO2003097111A2 (en) | 2003-11-27 |
EP1531892A2 (en) | 2005-05-25 |
CN1668357A (zh) | 2005-09-14 |
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