JP2018008096A - アンチセプティックアプリケーターおよびパッケージング技術 - Google Patents
アンチセプティックアプリケーターおよびパッケージング技術 Download PDFInfo
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- JP2018008096A JP2018008096A JP2017171461A JP2017171461A JP2018008096A JP 2018008096 A JP2018008096 A JP 2018008096A JP 2017171461 A JP2017171461 A JP 2017171461A JP 2017171461 A JP2017171461 A JP 2017171461A JP 2018008096 A JP2018008096 A JP 2018008096A
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- applicator
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- applicators
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Images
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Abstract
Description
本出願は、「アンチセプティックアプリケーターおよび防御デバイス(Antiseptic Applicators and Protective Devices)」と題された2012年2月6日出願の米国特許仮出願第61/595,635号に対して優先権を主張する「アンチセプティックアプリケーターおよびパッケージング技術(Antiseptic Applicators and Packaging Techniques)」と題された2013年2月1日出願の米国特許仮出願第13/757,318号に対して優先権を主張し、両方ともその全体が参照により本明細書に組み込まれる。
本開示は、感染を低減および/または防止するように設計された医療用アプリケーターを記載する。一実施形態では、本開示は、浸透性の吸収性および/または吸着性の底部層に結合された不浸透性層を有する例示的なアプリケーターまたはワイプを記載する。このアプリケーターまたはワイプの無菌性パッケージは、開口されたとき使用者に対して不浸透性層を露出し、従って、使用者の手が既存の感染性因子を浸透性の底部層および患者または表面に移行することを防ぐように設計されている。いくつかの実施形態では、このアプリケーターまたはワイプは、静脈内(IV)ラインポート、他のIV構成要素(例えば、シリンジ、管腔、弁など)、感染部位、血液吸引部位(例えば、静脈、動脈または毛細血管から)、医療用具(例えば、デジタル体温計または聴診器)、創傷部位、切開部位、腹膜透析液部位、排出部位、または感染を受けやすい任意の他の部位もしくは表面を、清浄化、衛生化および/または消毒するために単独で、または1つ以上の洗浄剤、抗菌剤または消毒剤と組み合わせて用いられ得る抗菌組成物を含む。
1つの例示的な実行では、本明細書に記載のアプローチと組み合わせて用いられ得る抗菌組成物は、例えば、参照により本明細書に組み込まれる、Tennicanらに対する2011年1月21日出願の国際特許出願番号PCT/US2011/022150、およびTennicanに対する2012年11月28日出願の米国特許本出願第13/688,078号に記載される組成物を含んでもよい。例えば、抗菌組成物は、水(H2O)、強力かつ非毒性のキレート剤、例えば、エチレンジアミン四酢酸(EDTA)(例えば、EDTA二ナトリウム、EDTAカルシウム二ナトリウム、EDTAマグネシウム、EDTAカリウム、EDTAガリウム)またはクエン酸ナトリウム(またはEDTAの他の酸、塩、誘導体もしくは他の形態、またはクエン酸ナトリウム)、短鎖一価アルコール(例えば、C2H5OHの分子式およびC2H6Oの実験式を有するエタノール)および強力な、低分子酸化剤、例えば、過酸化水素(H2O2)を含んでもよい。1つの特定の実施例では、この組成物は、水、EDTA、エタノールおよび過酸化水素から本質的に構成され得る。追加の成分としては、増粘剤、ゲル化剤、界面活性剤、発泡剤および/または泡安定剤を挙げることができる。しかし、他の実施例では、他の抗菌組成物が、本開示に記載されるアプリケーターおよびデバイスと組み合わせて用いられてもよい。
種々の医療用アプリケーターが本明細書で記載される。例示的なアンチセプティックアプリケーターは、一般に図1および図2に関して記載される。
上記の任意の種々のアプリケーターは、種々のパッケージにおいて、個々にパッケージングされても、または複数のアプリケーターのキットに無菌的にパッケージングされてもよい。さらに、このアプリケーター自体が、洗浄剤、抗菌剤または消毒剤の破壊を阻害するためのUV防御材料を含むパッケージング内に追加してまたは代わりに収容されてもよい。
図4は、例示的なアンチセプティックアプリケーターを作動するという上記の技術の遂行のための例示的プロセス400を図示する。このプロセス400は、論理的フロー図として図示される。操作を記載する順序は、限定と解釈されることは意図せず、任意の多数の記載された操作を、任意の順序でおよび/または並行に組み合わせて、そのプロセスを実行してもよい。
本開示は、特定の構造的特徴および/または方法論的な作用を有する実施形態を記載するが、特許請求の範囲は、記載される特定の特徴にも作用にも必ずしも限定されないことが理解されるべきである。そうではなく、特定の特徴および作用は単に、開示の特許請求の範囲内におさまるいくつかの実施形態を例示するに過ぎない。
本発明は以下の実施の態様を含むものである。
1.不浸透性層であって、使用者とインターフェースするように構成された外面を有している、不浸透性層と;
前記不浸透性層に結合された上面と、表面とインターフェースするための底面とを有する、浸透性の吸収層と;
前記浸透性の吸収層内に配置され、かつそれによって担持される洗浄剤、抗菌剤または消毒剤と、
を有する、医療用アプリケーター。
2.前記不浸透性層が、ポリエチレン、シリコン酸化物でコーティングされたポリマーフィルム、ポリプロピレン、ポリシリコーン、ポリテトラフルオロエチレン、ポリ塩化ビニル、マイラー、またはそれらの混合物を含む、前記1に記載の医療用アプリケーター。
3.前記不浸透性層の前記外面が、リジッド構造、裏地付き構造、ドット付き構造、網状構造またはそれらの組み合わせを有する、前記2に記載の医療用アプリケーター。
4.前記浸透性の吸収層が、デンプンポリマー、セルロースゲル、ポリエチレン発泡体、ポリウレタン発泡体、シリコーンオープンセル発泡体、またはそれらの混合物を含む、前記1に記載の医療用アプリケーター。
5.前記浸透性の吸収層の前記底面が、材料を磨くように構成された、荒い構造、粗い構造、平滑な構造、マイクロ構造、ナノ構造、またはそれらの組み合わせを有する、前記1に記載の医療用アプリケーター。
6.前記洗浄剤、抗菌剤または消毒剤が、界面活性剤、水、低分子量アルコール、過酸化物または過酸化物発生剤またはキレート剤を含む、前記1に記載の医療用アプリケーター。
7.前記抗菌剤または消毒剤が、
約5〜約50mg/mlのエチレンジアミン四酢酸(EDTA)と;
多くとも約70容積%のエタノールと;
多くとも約7.5容積%の過酸化水素と;
水と;
を含む、前記1に記載の医療用アプリケーター。
8.前記医療用アプリケーターを保管するための無菌性パッケージングをさらに備え、前記パッケージングは、開口された場合、前記不浸透性層の前記外面を露出するように構成されている、前記1に記載の医療用アプリケーター。
9.前記無菌性パッケージングが、複数の医療用アプリケーターを別々におよび連続してストリップで保管するように構成されており、ここで前記医療用アプリケーターの各々が独立して前記ストリップ中に含まれており、かつ同じまたは異なる洗浄剤、抗菌剤または消毒剤を、前記ストリップ内の隣接する医療用アプリケーターとして含んでもよい、前記8に記載の医療用アプリケーター。
10.前記無菌性パッケージングが、複数の医療用アプリケーターを別々におよび連続して一連で保管するように構成されており、
前記一連の各々の医療用アプリケーターは、抗菌剤も消毒剤も含まないか、または医療手順における特定の工程に対応する、特定の洗浄剤、抗菌剤、または消毒剤を含み、かつ
前記パッケージングが、前記医療手順における前記工程に基づいて開口されるようにさらに構成されている、前記8に記載の医療用アプリケーター。
11.清浄化、衛生化または消毒すべき表面を特定するステップ;
前記表面に対して医療用アプリケーターを適用するステップであって、前記医療用アプリケーターが、
使用者とインターフェースするための外面を有する不浸透性の裏打ちと;
前記不浸透性の裏打ちに連結された第一の層と、前記表面とインターフェースするように構成された第二の層とを有する浸透性の表面と;
前記浸透性の表面内に配置された洗浄剤、抗菌剤または消毒剤であって、前記洗浄剤、抗菌剤または消毒剤が、少なくとも1つ以上の界面活性剤、水、低分子量アルコール、過酸化物または過酸化物発生剤またはキレート剤を含む、洗浄剤、抗菌剤または消毒剤と;
を含むステップ;
を含む、感染性因子の伝播を妨げる方法。
12.前記清浄化、衛生化または消毒すべき表面が、有機組織の領域、または不活性材料の領域である、前記11に記載の方法。
13.前記清浄化、衛生化または消毒すべき表面に対して前記医療用アプリケーターを適用するステップ:
前記医療用アプリケーターの前記不浸透性の裏打ちの前記外面を露出するように構成された無菌性パッケージングを開口するステップ;
前記医療用アプリケーターの前記不浸透性の裏打ちの前記外面を把持することによって前記医療用アプリケーターを取り外すステップ;
前記特定された表面に対して前記洗浄剤、抗菌剤または消毒剤を含んでいる前記浸透性の表面の前記第二の層をふき取るステップ;
前記洗浄剤、抗菌剤または消毒剤が1つ以上の細菌、1つ以上の芽胞、1つ以上の寄生生物、1つ以上のウイルス、1つ以上の体液、またはそれらの混合物と接触する視覚的な指標を、ふき取りに少なくとも部分的に応答して、受容するステップ;
をさらに含む、前記11に記載の方法。
14.前記無菌性パッケージングが、複数の医療用アプリケーターを独立して保管するように構成されており、
前記医療用アプリケーターの各々が、連続してストリップで保管されており、
前記ストリップ中の前記医療用アプリケーターの各々が、種々の濃度の洗浄剤、抗菌剤または消毒剤を含む、
前記13に記載の方法。
15.前記不浸透性の裏打ちの前記外面が、リジッド、裏地付き、ドット付き、粘着性または網状の構造で構成されている、前記13に記載の方法。
16.浸透性の吸収材であって、表面と相互作用するように構成された外側基部を有する浸透性の吸収材と;
前記浸透性の吸収材中に配置された抗菌剤または消毒剤であって、水、過酸化水素、過酸化カルバミド、エチレンジアミン四酢酸(EDTA)、EDTAの塩、クエン酸ナトリウム、または他の生体適合性キレーター、またはアルコールのうちの少なくとも1つを含む、抗菌剤または消毒剤と;
前記浸透性の吸収材を保管するための無菌性パッケージと;
を備える、医療用アプリケーター。
17.前記浸透性の吸収材が、デンプンポリマー、セルロースゲル、ポリエチレン発泡体、および/またはシリコーンオープンセル発泡体を含む、前記16に記載の医療用アプリケーター。
18.前記抗菌剤または消毒剤が:
約5〜約50mg/mlのエチレンジアミン四酢酸(EDTA)と;
多くとも約70容積%のエタノールと;
多くとも約7.5容積%の過酸化水素と;
水と;
を含む、前記16に記載の医療用アプリケーター。
19.前記無菌性パッケージングによって、複数の医療用アプリケーターを、別々にかつ連続して保管することが可能である、前記16に記載の医療用アプリケーター。
20.前記浸透性の吸収材の外側頂部に連結される可塑性の不浸透性の材料であって、無菌性パッケージングが開口されると、使用者に提示される可塑性の不浸透性の材料をさらに備える、前記16に記載の医療用アプリケーター。
Claims (1)
- 外面を有している、不浸透性層と、
前記不浸透性層に結合された上面と、表面とインターフェースするための底面とを有する、浸透性の吸収層と、
前記浸透性の吸収層内に配置され、かつそれによって担持される洗浄剤、抗菌剤または消毒剤と、
開口されると、前記不浸透性層の前記外面を露出するように構成されている、無菌性パッケージングと、
を有する、無菌性パッケージングに保管された医療用アプリケーター。
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