JP2020521540A - 薬液の移送および注射装置およびコンプライアンス監視を伴う方法 - Google Patents
薬液の移送および注射装置およびコンプライアンス監視を伴う方法 Download PDFInfo
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- JP2020521540A JP2020521540A JP2019564830A JP2019564830A JP2020521540A JP 2020521540 A JP2020521540 A JP 2020521540A JP 2019564830 A JP2019564830 A JP 2019564830A JP 2019564830 A JP2019564830 A JP 2019564830A JP 2020521540 A JP2020521540 A JP 2020521540A
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Abstract
Description
本出願は、2017年5月25日に出願された米国仮出願第62/511,088号の優先権および利益を主張する。本出願は、参照により、上記出願のそれぞれの明細書、図面および特許請求の範囲全体を、あたかもそれらが本明細書で完全に繰り返されているかのように組み込む。
図40〜42を参照すると、滅菌注射装置7は、覆われたトレイ132内の移送装置3に取り付けられ、充填バイアルを有する別個に包装されたバイアルホルダー2がカートン131に設けられる。使用者は、カートン131を清潔で平らな表面に置く。使用者は、蓋133をカートン131に開けて、移送装置3およびバイアルホルダーアセンブリ2を露出させる。使用者は、移送装置3のトレイからカバー132を取り外して、移送装置3および注射装置7を露出させる。使用者は、移送装置3をカートン131に残し、指示された場合にのみ注射装置7を取り外すように指示される。
本主題は、部分的には、好ましくは、使用者の開始時に、1つ以上の標準シリンジの注射可能内容物を注射装置に移送し、好ましくは対象者へのその後の自動注射のために注射装置を同時に加圧するための使い捨て1回使用の装置および方法に関する。本明細書で説明される装置および方法は、任意の適切な詳細な構成のものであってもよいが、シリンジの内容物を注射装置に移すように構成されることが好ましい。装置および方法は、単独で、または以下に記載され、および/または添付の図に示される特徴または態様と組み合わせて、上記の特徴または態様のいずれかを採用してもよい。また、装置は、使用者が注射装置に移送され、その後対象に送達される投与量を選択できるように構成されてもよい。装置は、注射装置に移す前に粒子または薬物粒子を除去するために内容物を濾過するようにさらに構成され、1つまたは複数のシリンジに捕捉された置換空気を濾過する滅菌フィルターを含み得る。装置は、シリンジから注射装置に注射剤を移すことのみを使用者に許可するために、さらに一方向弁を備えて構成されてもよい。また、装置は、注射装置で加圧された注射剤が充填ポートで装置に逆流するのを防ぐために、さらに一方向弁を備えて構成されてもよい。装置はまた、薬物移送の前に使用者が注射装置を取り外すことを防ぐため、または装置が移送装置から取り外されるまで注射装置を作動させないようにするロックアウトを含んでもよい。
注射可能な生物医薬品のかなりの部分は、長期安定性のために冷蔵条件(通常2〜8℃)を必要とする。これらの薬物は、使用時までこの低い温度に維持しなければ、効力の欠如による治療の失敗のリスクがある。現在、使用時に、患者は薬剤を冷蔵庫から取り出し、投与前に周囲温度または室温(通常は約15〜約32℃の範囲)まで自然に温めることが必要である。薬剤容器、例えば、包装されたまたは包装されていないバイアル、または事前に充填されたシリンジに応じて、この工程は最大30分以上かかる場合がある。薬物/装置を温めることが許可されていない場合、いくつかの潜在的な問題がある。まず、溶液の温度が低いため、薬物の粘度が3倍以上に増加し、小さな針から患者に液体を注入するのが難しくなる。第二に、装置が電子的に駆動される場合、冷たい電池のエネルギーは大幅に低下する可能性があり、期待どおりに機能しない場合がある。第三に、冷たい薬物は、注射された患者にとって非常により大きい痛みを伴う。また、使用者または患者は、子どもの安全の懸念、使用者が忘れる可能性の懸念、および/または、家を出るまで30分間待ちたくないときに仕事に出かける要求のために、加温のために注射装置を長時間、開けた場所に置いておくことが快適でない場合がある。
患者情報および教育に関する全国協議会(NCPIE)によれば、「薬物療法の遵守の欠如は、アメリカの他の薬物問題である」。患者の服薬アドヒアランス(時間通りの処方の補充/再補充)とコンプライアンス(処方を時間通りに、または処方に従って服用する)がないと、正常な健康状態に戻る通常の進行を複雑にする。さらに、服薬アドヒアランスとコンプライアンスの欠如は、追加の医療費と医師の診察、長期入院を伴う既に負担のかかった医療システムに多大な費用を追加する。したがって、状態の治療における薬剤の成功は、処方箋が満たされ、指示どおりに定期的に服用されるかどうかに依存する。現在、これは患者のみの責任である。しかし、十分に意図した患者でさえ、誤って薬の服用を忘れたり、症状が改善し始めたときに意図的に服薬を停止したりする場合がある。したがって、非コンプライアンスまたは非アドヒアランスが発生しているときに、患者、処方者、医療提供者、または別の第三者の参加者に警告する機構は、上記の理由で介入または備忘通知を許可するために非常に有益である。
Claims (20)
- a.ハウジングと、
b.前記ハウジング内に設けられた薬剤の貯蔵部と、
c.前記ハウジング内において、分注前位置と、前記貯蔵部と流体連通している分注位置との間で移動可能な注射カニューレと、
d.前記ハウジング上または内部に設置されたマイクロプロセッサと、
e.前記注射カニューレが前記分注前位置にある時と前記注射カニューレが前記分注位置にある時を検知するように構成された、前記マイクロプロセッサと通信するセンサシステムと、
f.前記カニューレの位置を示す遠隔受信機にデータを送信するように構成された、前記マイクロプロセッサと通信する送信機
を備える、注射装置。 - 前記ハウジング内に配置され、前記カニューレを前記分注前位置と前記分注位置との間で移動させるように構成された機構をさらに備え、前記センサシステムが前記機構に動作可能に接続される、請求項1に記載の注射装置。
- 前記機構は押しボタンを含み、前記押しボタンは、前記押しボタンが押されると前記カニューレが前記分注前位置から前記分注位置に移動されるように構成され、前記センサは前記押しボタンに動作可能に接続される、請求項2に記載の注射装置。
- 前記センサシステムは、前記押しボタンに取り付けられた赤外線送信機および赤外線受信機と、前記押しボタンの位置に対して固定されるように前記ハウジングに取り付けられた反射部材とを含む、請求項3に記載の注射装置。
- 前記赤外線送信機および前記赤外線受信機は、前記押しボタンの下側に取り付けられている、請求項4に記載の注射装置。
- 前記押しボタンは、前記カニューレが前記分注前位置にあるときの前記ハウジングに対する伸長位置と、前記カニューレが前記分注位置にあるときの前記ハウジングに対する後退位置との間を移動する、請求項4または請求項5のいずれか1項に記載の注射装置。
- 前記機構は、薬物の分注が完了すると、前記押しボタンを前記伸長位置に自動的に戻すように構成されている、請求項6に記載の注射装置。
- f.マイクロプロセッサ、電池、および接点を含む電子チップであって、前記電池と前記接点との間に電気的接触が行われると、前記電池はマイクロプロセッサに電力を供給する電子チップと、
g.前記電池と前記接点の間の電気的接触が回避されるように、前記電池と前記接点の間に取り外し可能に配置されるプルタブ
とをさらに含む、請求項1に記載の注射装置。 - 前記マイクロプロセッサおよび前記送信機が単一の構成要素に組み合わされる、請求項1に記載の注射装置。
- 前記送信機はブルートゥース送信機である、請求項1に記載の注射装置。
- 移送装置および注射装置を含み、
前記移送装置は、注射装置ドッキングステーションを含み、
移送装置および/または注射装置によって担持される無線信号送信ユニットを含む、
注射可能な液体薬物を対象に移送および投与するための薬剤の送達システム。 - 前記送信ユニットは、前記システムを識別するデータを含む無線周波数タグをさらに備え、前記無線周波数タグは、前記注射装置の起動および前記注射装置による注射の完了を知らせるように構成されるアクティブ無線周波数タグである、請求項11に記載の送達システム。
- 前記無線信号送信ユニットは、ブルートゥース低エネルギー(BLE)仕様に従う低電力送信用に構成される、請求項11に記載の送達システム。
- コインセル電池と、前記コインセル電池が前記無線信号送信ユニットに電力を供給するように構成された回路とをさらに備える、請求項11に記載の送達システム。
- 前記注射装置は、前記注射装置を起動させるための押しボタンを含み、前記無線信号送信ユニットは、前記押しボタン内に配置される、請求項11に記載の送達システム。
- 前記無線信号送信ユニットはマイクロプロセッサを含む、請求項11に記載の送達システム。
- 前記無線信号送信ユニットは、直径が約3/8インチまたは約9.5mm未満である、請求項11に記載の送達システム。
- ステップa.注射装置のカニューレの位置を感知するステップと、
ステップb.前記カニューレの位置を示すデータを遠隔受信機に送信するステップとを含む、注射装置の使用を監視する方法。 - 前記注射装置の回路に電力が供給されたことを検出するステップをさらに含み、前記回路はマイクロプロセッサおよび送信機を含む、請求項18に記載の方法。
- 前記ステップaは、前記注射装置の前記カニューレを作動させるために使用される押しボタンの位置を監視することを含む、請求項18に記載の方法。
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