JP4790982B2 - バンデージを通して領域を滅菌または消毒する方法および器具 - Google Patents
バンデージを通して領域を滅菌または消毒する方法および器具 Download PDFInfo
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Description
本明細書は、35U.S.C.§119(e)の元で、2001年6月15日に出願された米国仮出願番号60/298,790、名称「カテーテルおよび挿入部位の消毒方法および器具」;2001年6月25日に出願された米国仮出願番号60/300,803、名称「カテーテルおよび挿入部位の消毒方法および器具」;2001年8月31日に出願された米国仮出願番号60/316,744、「外傷部位の消毒方法および器具」;および2001年10月31日に出願された米国仮出願番号60/334,722、名称「包帯付きカテーテル挿入部位の消毒方法および器具」の権利を主張し、これら明細書はすべて本明細書中に参照により組み込まれる。
ある用途においては、対象の減菌または消毒に紫外線照射が用いられているが、紫外線は昔から、皮膚癌や日焼け、および他の有害な皮膚への影響と関連する。一般の常識および慣習によれば、皮膚を紫外線照射にさらさないことが推奨される。
本発明の一つの態様は、患者のバンデージの下にある領域を滅菌または消毒する方法である。該方法は、バンデージを通して紫外線を該領域に照射する行為を含む。
本発明の他の態様は、患者の組織の領域を滅菌または消毒するための器具である。該器具は、紫外線発光ランプおよび、該ランプから発光される紫外線の少なくとも一部を透過するために用いられるバンデージを含む。該バンデージは、前記組織の領域の少なくとも一部を被覆する。
本発明のさらなる態様は、紫外線透過バンデージの使用方法である。該方法は、患者の皮膚にバンデージを適用すること、および該バンデージを通して皮膚に紫外線を照射することを含む。
上述のように、紫外線は皮膚に対して潜在的に有害である。そのため、多くの人々は紫外線にさらされることに対して予防措置を取る。この認知された危険な特徴のため、紫外線は、傷のある皮膚や健康な皮膚またはカテーテルの挿入部位を含む皮膚の滅菌または消毒用として、考慮されていなかった。
図1は、本発明の一つの態様により、患者の皮膚または組織の領域を、滅菌光または消毒光を用いて滅菌または消毒する方法を示す。滅菌光または消毒光は光源7から発光され、外傷1および/または周辺組織5を照射する。組織5は、皮膚3および皮膚3の表面下の組織を含む。滅菌または消毒光は皮膚3により大幅に弱められはするが、光の一部は皮膚3の下の組織に浸透する可能性があり、例えば皮膚3の孔を照射する。反射板9は光源7の近傍に配置され、光源7から発光される光を外傷1および周辺の皮膚3に向けるのを補助する。反射板9は光源7の上部に配置して示されているが、光源7のどちら側に位置してもよく、またなくてもよい。さらに、本発明にしたがって、さらなる反射板を光源7の周辺に含んでもよい。
図3および4A〜4Eは、本発明の一つの態様による、1または2回以上の閃光を発生するために用いられる瞬間滅菌/消毒ユニット16aを示す。図3に示すように、ハウジング17は閃光源7aおよび反射板9を取り囲んでいる。反射板9は、閃光源7aの傍に配置され、閃光源7aから発光された光がある範囲の角度に反射されるように働き、それによってカテーテル15の影になる皮膚の面積を最小化する。
図5A〜5Cは、本発明の一つの態様による、一定の時間連続照射を発生するために用いられる連続プロセス滅菌/消毒ユニット16bを示す。連続プロセス滅菌/消毒ユニット16bは、連続光源7bからより低い強度の光がより長い時間発生されることを除き、瞬間滅菌/消毒ユニット16aと同じ原理に基づいて作動する。
挿入部位11近くのカテーテル15の完全滅菌のため、挿入部位11近くのカテーテル15上の全ての部分が、適切な用量の滅菌光にさらされることが望ましい。さらに、微生物が挿入部位11から体内に入るのを防ぐため、挿入部位11および周辺の皮膚3が滅菌または消毒されることが望ましい。幾つかのカテーテル要素の形態が、挿入部位11近くのカテーテル15および皮膚3上の全ての部分(カテーテルが皮膚上に配置されている部分)に光が到達することを困難にしている。カテーテルは、他の領域に比べて受け取る光が少なく部分的に影になる領域を作り出し得る。この影の効果は、滅菌光の総用量が十分高ければ緩和できる。しかし、高い用量は、より出力の高いUV光源および/またはより長い照射時間を必要とし、皮膚へのUV照射が所望の量より大きくなる可能性がある。したがって、本発明の一つの態様においては、カテーテル要素の形態を影を減らすようなものにするか、および/または、光を反射あるいは屈折する要素を含んで、それがなければ部分的あるいは完全に影になる領域に光を導くようにする。
上述の滅菌/消毒ユニットは、素肌に適用すると有効な効果を有するようにもデザインされており、滅菌光の照射のために一時的に取り外すのであれば、従来のバンデージと共に用いることもできる。しかし、本発明の態様によれば、本明細書の滅菌または消毒方法は、滅菌/殺菌すべき領域上に置かれたUV透過バンデージと共に使用することもできる。用語「バンデージ」は、任意の包帯、医療用テープ、パッド、ガーゼ、フィルム、軟膏、またはペイント・オン外傷被覆剤(paint-on wound covering)、またはこれらの特性の任意の組合せを含むことを意図している。
図12は、UV透過バンデージ51と共に使用される図3および4の瞬間滅菌/消毒ユニット16aを示す。図示目的のため、バンデージ51は外傷1を覆っているように示されている。しかし、バンデージ51は代替的に、または付加的に、カテーテル、カテーテル挿入部位、または健康な皮膚を覆ってもよい。図13は、バンデージ51と共に使用される図5A、5B、および5Cの連続プロセス滅菌/消毒ユニット16bを示す。先と同様に、バンデージ51は外傷1を覆っているように示されているが、代替的に、または付加的に、カテーテル、カテーテル挿入部位、または健康な皮膚を覆ってもよい。
図14A、14Bおよび14Cは、バンデージ51と共に使用する、光誘導要素41ならびに図7A、7Bおよび7Cの瞬間滅菌/消毒ユニット16aを示す。瞬間滅菌/消毒ユニット16aが図示されているが、他の滅菌/消毒デバイス、例えば連続プロセス滅菌/消毒ユニット16bもまた、代替的にこの態様において使用できることが理解される。バンデージ51と共に使用する場合、光誘導要素41は、カテーテル15のチューブ12およびバンデージ51と共に気密シールを形成し、空気により伝播される外部の微生物による、挿入部位11の汚染を防ぐことができる。光誘導要素41は、図14Cに示すように、カテーテル15の上に滑らかな凸状の表面を提供し、その上にバンデージ51が容易に接着することにより、この気密シールの形成を支援する。光誘導要素41がなければ、バンデージ51が皮膚3とカテーテル15のチューブ12の底面との間に完全なシールを形成するのは困難である。
完全な気密シールを形成するために、光誘導要素41は、カテーテル15のチューブ12と緊密に接触するようデザインされている。これは種々の方法によって達成することができ、その例としては、エラストマーからモールディングにより、チューブ12の上に堅固に適合するよう光誘導要素41を形成する、光誘導要素41に溝を形成し、光誘導要素41にはその溝の少なくとも一部を満たすようなヒンジまたは分離した構成要素を付ける、エラストマーのシールを挿入された堅固な光誘導要素41を用いる、カテーテル15のエラストマーの特性を、堅固な光誘導要素41に対するシールとして用いる、または、カテーテル15のチューブ12の周りに接着材料を付加したシールを形成する、などがある。
本明細書に記載の滅菌/消毒ユニットは、専門医療環境において複数の患者に使用することができる。滅菌/消毒ユニットそれ自体は、一人の患者から他の患者へ微生物を運ぶベクター(媒介物)となり得る。特に、光シール19の底面48は、通常はUV光にさらされず、患者、カテーテル、またはバンデージに接触させられる。
本発明のある態様により、瞬間滅菌/消毒ユニット16aの閃光ランプに付随する電気回路を、図16の電気回路65に示すように組み込むこともできる。電気回路65は、上述の任意の態様に記載の滅菌/消毒ユニットにおいて使用することができる。電気回路65は、閃光ランプ67の電源供給に必要なエネルギーを貯蔵するコンデンサを含む高電圧電源69を用いる。電源71はAC電源または電池であり、使用する閃光ランプの特性に応じて、一般に200V〜1000Vの範囲の電圧を供給するが、供給電圧は200Vより少ない場合も、また1000Vより大きい場合もある。小さな線形閃光ランプは、一般に200V〜500Vの電圧で作動し、小さな閃光短アークランプ(small short-arc flash lamps)は1000V以上の電圧が必要となる場合もある。電圧は、閃光ランプの特性、すなわち1閃光に所望される総エネルギーおよび所望の最大閃光電流に基づいて選択される。高い電圧は、同じエネルギーでも高い閃光電流を提供し、その結果紫外線スペクトルにおける閃光出力のパーセンテージが高くなる。1閃光当たりのエネルギーは式1により決定できる:
E=1/2CV2 [1]
式中、Eはジュール単位の1閃光当たりのエネルギー、CはFarad単位のエネルギー貯蔵コンデンサの値、およびVはV単位の電圧である。滅菌/消毒用途には、閃光ランプが最大量の紫外線を生成するよう、選択された電圧はできるだけ高いことが望ましい。次にコンデンサの値は、1閃光当たりの所望のエネルギーを提供するよう選択する。滅菌/消毒を実施する閃光に必要なエネルギーは、照明する面積、所望の最少滅菌光用量、照明の均一性、および閃光ランプ67のスペクトルによって決定される。例えば、UVガラスで作られた閃光ランプが25平方cm(約4平方インチ)の面積を照明するために使用されると、総閃光入力エネルギーが約20Jで、約20mJ/cm2のUVCエネルギー強度を発生する。
Claims (20)
- 患者の組織の領域を滅菌または消毒するシステムであって、
滅菌または消毒用に構成された紫外線発光ランプ、および
該ランプから発光された紫外線の少なくとも一部を透過するよう調節されたバンデージ、
を含み、該バンデージが前記組織の領域の少なくとも一部を覆っており、該バンデージが、該バンデージの紫外線透過率を示すコードを含む、前記システム。 - バンデージが、紫外線発光ランプから発光された光スペクトルの選択された部分をフィルタリングする光フィルターを含む、請求項1に記載のシステム。
- バンデージが、患者の紫外線に照射される領域全体を覆っている、請求項1に記載のシステム。
- バンデージが可動ファスナーによってフィルムに取り付けられたパッドを含む、請求項1に記載のシステム。
- 組織の領域がカテーテル挿入部位を含む、請求項1に記載のシステム。
- 組織の領域が外傷部位を含む、請求項1に記載のシステム。
- 滅菌または消毒に必要な、バンデージの透過率および予め決定された紫外線照射量に基づき、請求項1〜6のいずれかに記載のシステムのバンデージの少なくとも一部の紫外線に対する透過率を決定する行為、および
該バンデージの少なくとも一部を通して照射すべき請求項1〜6のいずれかに記載のシステムの紫外線の強度を選択する行為、
を含み、前記行為がいずれも前記システムによって行われる、方法。 - バンデージの少なくとも一部における紫外線の透過率を決定する行為が、該バンデージ上の可視的インジケータを読み取ることを含む、請求項7に記載の方法。
- バンデージの少なくとも一部における紫外線の透過率を決定する行為が、該バンデージ上のバーコードを読み取ることを含む、請求項8に記載の方法。
- バンデージが、紫外線透過フィルム、および
該フィルムに連結され、フィルムが紫外線にさらされたことを表示する色変化材料、
を含む、請求項1に記載のシステム。 - フィルムに連結された接着剤が色変化材料を含む、請求項10に記載のシステム。
- 色変化材料が、該色変化材料を紫外線を照射する前の状態に戻すのに必要とする時間が、紫外線を照射する所望の間隔に対応するように選択される、請求項10に記載のシステム。
- 色変化材料がフィルムに埋めこまれている、請求項10に記載のシステム。
- カテーテルを保持し挿入部位付近の患者の皮膚とカテーテルの間のスペースを取るための導管を有する要素であって、皮膚と前記要素の少なくとも一部に接着しているバンデージとの間に、気密シールを形成するのを支援するよう、配置され形づくられている、前記要素、
を含み、挿入部位から患者の皮膚を通して挿入されるカテーテルと共に用いるデバイスをさらに含む、請求項1に記載のシステム。 - カテーテルを保持し挿入部位付近の患者の皮膚とカテーテルの間のスペースを取るための導管を有する要素であって、皮膚と前記要素の少なくとも一部に接着しているバンデージとの間に、光遮断シールを形成するのを支援するよう、配置され形づくられている、前記要素、
を含み、挿入部位から患者の皮膚を通して挿入されるカテーテルと共に用いるデバイスをさらに含む、請求項1に記載のシステム。 - 要素の少なくとも一部が、皮膚とバンデージの間に配置されている、請求項14に記載のシステム。
- 要素が、皮膚を通る挿入部位とバンデージの間に気密シールを形成するのを支援するよう、配置され形づくられている、請求項14に記載のシステム。
- 要素の少なくとも一部が、皮膚とバンデージの間に配置されている、請求項15に記載のシステム。
- 要素が、皮膚を通る挿入部位とバンデージの間に光遮断シールを形成するのを支援するよう、配置され形づくられている、請求項15に記載のシステム。
- 紫外線発光ランプが閃光ランプである、請求項1に記載のシステム。
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-
2002
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- 2002-06-17 JP JP2003505004A patent/JP4790982B2/ja not_active Expired - Fee Related
- 2002-06-17 WO PCT/US2002/019147 patent/WO2002102419A2/en active Application Filing
- 2002-06-17 EP EP10180227A patent/EP2295112A1/en not_active Withdrawn
- 2002-06-17 CN CNA028115201A patent/CN1531449A/zh active Pending
- 2002-06-17 EP EP02744387A patent/EP1395338B1/en not_active Expired - Lifetime
- 2002-06-17 AU AU2002344752A patent/AU2002344752A1/en not_active Abandoned
- 2002-06-17 DE DE60238677T patent/DE60238677D1/de not_active Expired - Lifetime
- 2002-06-17 CA CA2447881A patent/CA2447881C/en not_active Expired - Fee Related
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2003
- 2003-08-15 US US10/641,894 patent/US20040034398A1/en not_active Abandoned
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JP2005508664A (ja) | 2005-04-07 |
US20030031586A1 (en) | 2003-02-13 |
EP1395338A4 (en) | 2005-09-21 |
CA2447881A1 (en) | 2002-12-27 |
JP2009261957A (ja) | 2009-11-12 |
EP1395338A2 (en) | 2004-03-10 |
WO2002102418A2 (en) | 2002-12-27 |
DE60238677D1 (de) | 2011-02-03 |
WO2002102418A3 (en) | 2003-10-30 |
US20040034398A1 (en) | 2004-02-19 |
CN1531449A (zh) | 2004-09-22 |
WO2002102419A2 (en) | 2002-12-27 |
JP5148560B2 (ja) | 2013-02-20 |
WO2002102419A3 (en) | 2003-07-31 |
US20030018373A1 (en) | 2003-01-23 |
EP2295112A1 (en) | 2011-03-16 |
US6730113B2 (en) | 2004-05-04 |
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