JP6555885B2 - 埋込型カテーテルの電気化学的殺菌 - Google Patents
埋込型カテーテルの電気化学的殺菌 Download PDFInfo
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Description
本出願は、米国特許法第119条第e項第1節の下で、それらの全ての開示が本明細書に参照して組み込まれる、2011年6月20日に出願された米国仮特許出願第61/499,066号明細書、2011年6月21日に出願された同第61/499,529号明細書、および2012年5月17日に出願された同第61/648,484号明細書に対する優先権を主張するものである。 本発明は、概して埋込型の「留置」カテーテルに関する。より詳細には、本発明は、カテーテル表面上のバイオフィルムの存在を検出し、患者の身体から該カテーテルを抜去することなく該バイオフィルム内の微生物を殺滅するためのシステムおよび方法に関する。
カテーテル、例えば、動脈カテーテル、中心静脈カテーテル、透析チュービング、気管内チューブ、経腸栄養チューブ、胃瘻チューブ、血液透析カテーテル、鼻腔栄養チューブ、腎瘻チューブ、肺動脈カテーテル、気管切開チューブ、臍帯カテーテル、および導尿カテーテル、
インプラント、例えば、動静脈シャント、乳房インプラント、心臓およびその他のモニタ、人工内耳、除細動器、歯科インプラント、顎顔面インプラント、人工中耳、神経刺激器、矯正器具、ペースメーカおよびリード、人工ペニス、補綴器具、人工関節、脊椎インプラント、および発声プロテーゼ、ならびに
その他の埋込型器具、例えば人工心臓、コンタクトレンズ、骨折固定器具、注入ポンプ、インスリンポンプ、頭蓋内圧器具、眼内レンズ、子宮内避妊器具、人工関節、心臓機械弁、オマヤレザバ、縫合材料、尿管ステント、血管支援器具、血管グラフト、血管シャント、および血管ステントが含まれる。
他に特に規定しない限り、本明細書で使用する全ての技術用語および科学用語は、本発明が関与する分野の当業者によって一般に理解されている意味を有する。以下では、本発明の説明にとって特に重要である特定の用語について規定する。
そこで本発明の埋込型カテーテルは、その外面および/または内面上に存在するバイオフィルム内の感染微生物を殺滅するため、および/またはその上のバイオフィルム増殖を防止するために電気化学的に活性化できる埋込型カテーテルである。該バイオフィルム内の感染微生物は、典型的には細菌細胞であるが、さらに酵母、真菌、糸状菌、または該バイオフィルム内の他のコロニー形成微生物のコロニーであってよい。
本発明の埋込型カテーテルを製造するためには様々な技術を使用できる。適切な製造技術には、無電解めっき(化学めっきもしくは自己触媒めっきとしても公知である)、押出、化学蒸着(CVD)、および印刷が含まれる。外部電極を提供するためには上記の技術の全てを使用できるが、無電解めっきおよび押出は、内部および外部両方の電極を有する埋込型カテーテルを製造するための選択法である。
本発明を実施するために適切な操作パラメータは、対象とする使用方法および電圧印加レジメンに依存して変動するであろう。つまり、本発明の方法を使用すると、埋込型カテーテル表面上に存在するバイオフィルム内の微生物を殺滅する、該埋込型カテーテル表面上のバイオフィルムの増殖を防止する、または該埋込型カテーテル表面上のバイオフィルムの形成を感知することができる。さらに、該カテーテル表面上で生成された電場は、間欠的もしくは連続的いずれかで電圧源によって印加することができる。
本発明の埋込型カテーテルは、カテーテルが患者の体内に埋め込まれる様々な多数の状況において利用される。一般に、本発明の方法および埋込型カテーテルは、広範囲のカテーテルタイプ、例えば動脈カテーテル、中心静脈カテーテル、透析チュービング、気管内チューブ、経腸栄養チューブ、フォーリ(Foley)カテーテル、胃瘻チューブ、血液透析カテーテル、経鼻胃チューブ、腎瘻チューブ、肺動脈カテーテル、気管切開チューブ、中耳腔換気用チューブ、シャント、臍帯カテーテル、導尿カテーテルなどと結び付けて利用できる。一般に好ましいカテーテルタイプは、短期および長期留置カテーテルであり、短期カテーテルは30日間未満にわたり適所に留置され、長期カテーテル法は30日間を超えて埋込を必要とすると規定されている。
材料および方法
菌株および増殖条件:全試験を通して緑色蛍光タンパク質(Gfp)で標識され、表1に記載した特徴を備える緑膿菌(PAO1)を使用した。少数の実験では、同様に表1に列挙した大腸菌および黄色ブドウ球菌の菌株を使用した。菌株は、1mMのMgCl2、0.1mMのCaCl2、および0.01mMのFeCl3が添加されたM9培地中で増殖させた。培地は、0.9%の生理学的/血流中NaClの濃度で調製した。さらに、1mMのグルコースをバッチ実験のために単独炭素源として加え、フローチャンバ実験のためには0.01mMのグルコースを加えた。黄色ブドウ球菌のためにはトリプチカーゼソイブロス(TSB)を増殖培地を使用した。必要な場合は、抗生物質を100μg/mLのアンピシリンおよび20μg/mLのゲンタマイシンの最終濃度で加えた。生細胞および死細胞の視認は、生細胞を緑色蛍光によって、死細胞を赤色蛍光によって示す、Molecular Probes社(米国オレゴン州ユージーン)からのBaclight生死染色を用いて染色することによって実施した。Gfpが細胞(例、PAO1について)中で構成的に発現した場合は、生細胞はGfpからの緑色蛍光によって提示される。
共焦点顕微鏡を使用して入手し、図7〜15および17に示した画像は、バイオフィルム増殖を阻害することにおける本発明の本電気化学方法およびシステムの有効性を微生物の殺滅およびバイオフィルム増殖の防止の両方に関して確証している。
Claims (7)
- 患者の身体から抜去することなくバイオフィルム阻害濃度の酸化剤を作り出すことにより電気化学的に殺菌できる埋込型カテーテルであって:
誘電材料を含む細長いカテーテル本体であって、近位端、遠位端、カテーテル本体を通して伸長していて前記近位端から前記遠位端まで流体を輸送するために適応する1つのルーメン、前記カテーテル本体の外部上の外面、および前記ルーメンの内部上の内面を有するカテーテル本体、および
前記カテーテルの外面上にありそれと一体である少なくとも2つの外部電極であって、前記外部電極は細長く前記カテーテル本体の外面に沿って前記近位端から前記遠位端へ長手方向に伸長している外部電極、
を含み、
前記2つの外部電極は、前記外面から前記カテーテル本体の壁を通して前記内面に向かって半径方向内向きに伸長し、それにより付加的に内部電極として機能し、
前記2つの外部電極は、一対の間隙によって分離されており、
前記間隙は、前記カテーテル本体の誘電材料を含み、前記カテーテル本体の外面から内面に半径方向内向きに伸長し、及び、前記近位端から前記遠位端に長手方向に伸長しており、
前記カテーテルは、加えられる殺生物剤の非存在下で、患者の身体に埋め込まれた前記カテーテルを患者の身体から抜去することなく、前記患者の身体に存在する内因性化合物からバイオフィルム阻害濃度の酸化剤を作り出すために有効である大きさの電圧であって、前記外部電極に電圧源から印加される該電圧を受け取るための手段をさらに有する、
該埋込型カテーテル。 - 前記外部電極が、作用電極および対電極として機能するアノードおよびカソードを含み、参照電極として機能する第3電極をさらに含む、請求項1に記載のカテーテル。
- 前記カテーテル本体は、シリコーン、ポリウレタン、ポリ塩化ビニル、ポリエチレン、またはラテックスを含む柔軟性エラストマ材料から構成される、請求項1又は2に記載のカテーテル。
- 前記電極は、炭素−ポリマー複合体から構成される、請求項1〜3のいずれか1に記載のカテーテル。
- 前記電極が、
(a)金属製であるか、または炭素粒子および熱硬化性もしくは熱可塑性ポリマーを含む炭素−ポリマー複合体から構成され、
(b)1,000Å〜2μm、または10μm〜200μmの範囲内の間隙によって分離され、または
(c)500Å〜30μmの厚さを有する、
請求項1〜4のいずれか1に記載のカテーテル。 - 前記カテーテルが、
(a)複数のアノードおよび同数のカソードを含む複数の外部電極を有し、
(b)静脈に埋め込まれた中心静脈カテーテルであり、または
(c)前記カテーテルの少なくとも前記外面上に存在する、または形成されるバイオフィルムであって、前記バイオフィルム内の微生物を殺滅する工程を行われた、バイオフィルムを含む、
請求項1〜5のいずれか1に記載のカテーテル。 - (a)前記電圧が、直流電源、交流電源、およびパルス電圧源から選択される電圧源により供給され、前記電圧源は前記電極と電気通信しており、
(b)前記電圧が、交流電源である電圧源により供給され、
(c)前記電圧が、直流電源である電圧源により供給され、極性は、各電極がアノードとして機能することとカソードとして機能することの間で交替するように長期間を通して交替し、
(d)前記電圧が、直流電源である電圧源により供給され、極性は、各電極がアノードとして機能することとカソードとして機能することの間で交替するように長期間を通して交替し、ここで、前記極性は5〜30分毎に交替し、
(e)前記電圧が、ポータブル型電池パックの形態にある直流電源である電圧源により供給され、
(f)前記電圧が、15分間〜6時間、または30分間〜3時間の範囲内の期間にわたりほぼ一定間隔で間欠的に印加され、
(g)前記電圧が、少なくとも72時間の長期間にわたって連続的に印加され、
(h)前記電圧の大きさが、0.3V〜1.3V、0.3V〜0.7V、0.2V〜1.0V、0.5V〜1.5V、0.6V〜1.2V、または0.8V〜1.2Vの範囲内であり、または
(i)印加された前記電圧は、前記カテーテル本体の少なくとも前記外面上で5μA/cm2〜50μA/cm2、5μA/cm2〜200μA/cm2、10μA/cm2〜200μA/cm2、または20μA/cm2〜200μA/cm2の範囲内の電流密度を生じさせる、
請求項1〜6のいずれか1に記載のカテーテル。
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2016
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AU2012272993B2 (en) | 2016-02-04 |
US9320832B2 (en) | 2016-04-26 |
JP2015507481A (ja) | 2015-03-12 |
US20160193388A1 (en) | 2016-07-07 |
CA2837726A1 (en) | 2012-12-27 |
EP2720727B1 (en) | 2019-06-19 |
US9381276B1 (en) | 2016-07-05 |
CA2837726C (en) | 2016-09-20 |
AU2012272993A1 (en) | 2013-12-19 |
EP2720727A1 (en) | 2014-04-23 |
US20130041238A1 (en) | 2013-02-14 |
WO2012177807A1 (en) | 2012-12-27 |
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