JP5777609B2 - ナノ銀を用いた骨接合 - Google Patents
ナノ銀を用いた骨接合 Download PDFInfo
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- JP5777609B2 JP5777609B2 JP2012513507A JP2012513507A JP5777609B2 JP 5777609 B2 JP5777609 B2 JP 5777609B2 JP 2012513507 A JP2012513507 A JP 2012513507A JP 2012513507 A JP2012513507 A JP 2012513507A JP 5777609 B2 JP5777609 B2 JP 5777609B2
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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Description
コロイド分散系を準備する工程と、
処理対象の医療用デバイスの表面が前記コロイド分散系に浸漬するように、該医療用デバイスを該コロイド分散系に曝す工程と、
前記コロイド分散系に配置される第一電極及び/又は第二電極として前記医療用デバイスの間で、好ましくは非対称若しくは対称の、又は非対称と対称との組合せのAC電圧差を発生させる工程と、
を含み、プラズマ電解酸化により浸漬した表面を酸化物膜へと変換させ、該変換された表面が前記コロイド分散系のコロイド分散粒子で形成される島に一部覆われている、好ましくは非生分解性材料の医療用デバイス、特に金属製の医療用デバイスの表面を処理する方法を提唱する。
コロイド分散系を含有する槽と、
好ましくは前記槽中でコロイド分散系を混合する手段と、
処理対象の医療用デバイスの表面がコロイド分散系に浸漬するように医療用デバイスを保持する手段であって、医療用デバイスが第一電極を与える、手段と、
前記槽中に含有されるコロイド分散系に第二電極を与える手段と、
前記第一電極及び/又は前記第二電極に供給されるAC電圧を発生させる電源ユニットと、
前記第一電極及び/又は前記第二電極を前記電源ユニットに接続する手段と、
を備え、前記第一電極を接続する手段を、断面積比が0.1〜10の範囲になるように浸漬した医療用デバイスに適合させる、装置も提唱している。好ましくは、断面積比は0.75〜4の範囲である。
皮膚への常在(Primary occupant)、
補綴デバイスの表面へのコロニー形成、
バイオフィルム形成→患者の免疫系に対する遮断→抗生物質の使用の必要性、
抗生物質耐性株の蔓延(ドイツにおける全ての表皮ブドウ球菌株に対するMRSEの実際の割合:約70%)。
陰性対照:HDPEロッド(指数関数的な成長を示すものとする)、
中程度の成長対照:マイクロタイタープレートの幾つかのウェルに、最適な条件下で細菌成長を制御するためにコンタミネーションした栄養溶液を充填した、
滅菌対照:ブランクウェル及びコンタミネーションしていないサンプルは全く細菌成長を示さないものとする、
陽性対照:純Agロッド(成長が検出不可能なものとする)。
ブランクサンプル:TiAl6V4 Eli合金ロッド、
ナノ銀コーティングを有するサンプル:Ag−TiO2コーティング(5%処方)を有するTiAl6V4 Eli合金ロッド。
ブランクサンプル:TiAl6V4 Eli合金板、
ナノ銀コーティングを有するサンプル:Ag−TiO2コーティング(5%処方)を有するTiAl6V4 Eli合金板、
陰性対照:ポリスチレン表面(或る特定数の細菌が生存しなければ、試験を取りやめる必要がある)。
試験シリーズA(仮動的モデル):
サンプルを1mlのPBSに浸漬させ、
1日20℃でゆっくりと振盪した後、サンプルを新たなPBSの入った次のバイアルに移す。
試験シリーズB(静的モデル):
サンプルを10mlのPBSに浸漬させ、
或る特定間隔の37℃でのゆっくりとした浸盪の後、アリコート(0.5ml)を新たなバイアルに移す。
PBSにおけるAg含有量を硝酸の添加後に分析し、
黒鉛炉原子吸光分析法(GF−AAS)により銀分析を行う。
ブランクサンプル:TiAl6V4 Eli合金ロッド(Tiロッド)、
ナノ銀コーティングを有するサンプル:Ag−TiO2コーティングを有するTiAl6V4 Eli合金ロッド、
陽性対照:純銀ロッド(Agロッド)。
試験シリーズA:ナノ銀コーティングは、純銀ロッドと酷似した銀放出を示す。
純銀ロッドからの1日の放出は1日目の減少後、一定のままである。
ナノ銀ロッドからの1日の放出は一定であり、
15日間の浸出の間に浸出したAg量の合計:6.3μg。
Ag+ aq⇔Ag+ solid[酸化Ag(AgCl、Ag2O...)由来]
この場合、平衡時の銀放出は約0.4ng/g/mm2である。
装置:Bruker D8 GADDS XRD(電圧:40KV及び電流の強さ:40mA)
測定範囲:角度θ:17°〜93.7°、増分:0.02°、及びステップ時間:60秒
測定点:チタンスクリューの最上部。
Claims (40)
- 医療用デバイスの表面を処理する方法であって、
コロイド分散系を準備する工程と、
処理対象の医療用デバイスの表面が前記コロイド分散系に浸漬するように、該医療用デバイスを該コロイド分散系に曝す工程と、
前記コロイド分散系に配置される第一電極及び/又は第二電極として前記医療用デバイスの間でAC電圧差を発生させる工程と、
を含み、プラズマ電解酸化により浸漬した表面を酸化物膜へと変換させ、該変換された表面が前記コロイド分散系のコロイド分散粒子で形成される島に一部覆われており、前記コロイド分散粒子が30nm以下の平均径を有するAg粒子として与えられ、
均一な電場分布が、接続される医療用デバイスの断面に応じて適合させた低減断面積又は適合させた増大断面積を有する第一電極を接続する手段により達成されるように、AC電位差は電源ユニットにより発生し、第一電極及び/又は第二電極に供給され、および
前記医療用デバイスの断面積を前記第一電極を接続する手段の断面積で除算した商で示される断面積比が0.75〜4の範囲である、医療用デバイスの表面を処理する方法。 - 前記AC電圧差の最大値が0.1V〜4800Vの範囲で与えられる、請求項1に記載の方法。
- 前記AC電圧が0.01Hz〜1200Hzの周波数で与えられる、請求項1又は2に記載の方法。
- 前記AC電圧が非対称のAC電圧として与えられる、請求項1〜3のいずれか一項に記載の方法。
- 前記AC電圧の負の成分が−1200V〜−0.1Vの範囲の振幅で与えられ、かつ/又は該AC電圧の正の成分が0.1V〜4800Vの範囲の振幅で与えられる、請求項4に記載の方法。
- 前記正の振幅を前記負の振幅で除算した商を1超から4までの範囲の商の絶対値に調整する、請求項4又は5に記載の方法。
- 前記AC電圧が対称のAC電圧として与えられる、請求項1〜3のいずれか一項に記載の方法。
- 前記AC電圧の負の成分が−2400V〜−0.1Vの範囲の振幅で与えられ、かつ/又は該AC電圧の正の成分が+0.1V〜+2400Vの範囲の振幅で与えられる、請求項7に記載の方法。
- 0.0001A/dm2〜500A/dm2の電流密度が与えられる、請求項1〜8のいずれか一項に記載の方法。
- 前記コロイド分散系の温度が−20℃〜+150℃の範囲で与えられる、請求項1〜9のいずれか一項に記載の方法。
- 前記コロイド分散系が0リットル/分〜5000リットル/分の循環速度で循環する、請求項1〜10のいずれか一項に記載の方法。
- 前記コロイド分散系が水性分散液である、請求項1〜11のいずれか一項に記載の方法。
- 前記医療用デバイスの材料の少なくとも1つの構成要素である少なくとも1つの電解質が、前記コロイド分散系中で与えられる、請求項1〜12のいずれか一項に記載の方法。
- 堆積速度が0.01μm/秒〜1μm/秒の範囲にある、請求項1〜13のいずれか一項に記載の方法。
- 堆積時間が1秒〜1200秒の範囲にある、請求項1〜14のいずれか一項に記載の方法。
- 前記粒子がアパタイト粒子として与えられる、請求項1〜15のいずれか一項に記載の方法。
- 前記粒子がCu粒子及び/又はZn粒子として与えられる、請求項1〜15のいずれか一項に記載の方法。
- 前記粒子が前記医療用デバイスの材料の少なくとも1つの構成要素により与えられる、請求項1〜17のいずれか一項に記載の方法。
- 前記粒子が添加剤として与えられ、該添加剤が金属、酸化物、土類鉱物及びホスフェートからなる群から選択される少なくとも1つの材料である、請求項1〜18のいずれか一項に記載の方法。
- 前記粒子が100mg/l以下の濃度で与えられる、請求項1〜19のいずれか一項に記載の方法。
- ガスが前記コロイド分散系において与えられる、請求項1〜20のいずれか一項に記載の方法。
- 請求項1〜21のいずれか一項に記載の方法で作製される医療用デバイス。
- 被処理表面を有する非生分解性の金属又は金属合金を含む医療用デバイスであって、
前記被処理表面を少なくとも一部、コロイド分散粒子を有するコロイド分散系を用いたプラズマ電解酸化により酸化物膜へと変換させ、ここで、前記コロイド分散粒子が30nm以下の平均径を有するAg粒子を含み、
前記変換された表面が前記コロイド分散系の前記コロイド分散Ag粒子で形成される島に一部覆われており、
ステレオ型光学顕微鏡検査及びトポグラフィ造影モードの走査型電子顕微鏡検査で検査したコーティング表面のトポグラフィが、表面の均一でかつ均質なコーティングを示す、
被処理表面を有する非生分解性の金属又は金属合金を備える医療用デバイス。 - 前記粒子がCu粒子及び/又はZn粒子として与えられる、請求項23に記載の医療用デバイス。
- 前記粒子が前記医療用デバイスの材料の少なくとも1つの構成要素である構成要素により与えられる、請求項23又は24に記載の医療用デバイス。
- 前記粒子がアパタイト粒子を含む、請求項23、24及び25のいずれか一項に記載の医療用デバイス。
- 前記粒子が添加剤を含み、該添加剤が金属、酸化物、土類鉱物及びホスフェートからなる群から選択される少なくとも1つの材料である、請求項23〜26のいずれか一項に記載の医療用デバイス。
- 前記島の平均領域サイズが1000nm未満である、請求項23〜27のいずれか一項に記載の医療用デバイス。
- 前記島の平均厚さが1nm〜1000nmである、請求項23〜28のいずれか一項に記載の医療用デバイス。
- 前記酸化物膜の厚さが1μm〜100μmである、請求項23〜29のいずれか一項に記載の医療用デバイス。
- 前記被処理表面の島の被覆平均量が20%未満である、請求項23〜30のいずれか一項に記載の医療用デバイス。
- 前記被処理表面のAg浸出速度が120ng/cm2/日未満である、請求項23〜31のいずれか一項に記載の医療用デバイス。
- 前記インプラントが、チタン、チタン合金、クロム合金、コバルト合金及びステンレス鋼からなる群から選択される少なくとも1つの金属を含む、請求項23〜32のいずれか一項に記載の医療用デバイス。
- プラズマ電解酸化により医療用デバイスの表面を処理する装置であって、以下の構成要素:
コロイド分散系を含有する槽と、
前記槽中でコロイド分散系を混合する手段と、
処理対象の医療用デバイスの表面がコロイド分散系に浸漬するように医療用デバイスを保持する手段であって、医療用デバイスが第一電極を与える、手段と、
前記槽中に含有されるコロイド分散系に第二電極を与える手段と、
前記第一電極及び/又は前記第二電極に供給されるAC電圧を発生させる電源ユニットと、
前記第一電極及び/又は前記第二電極を前記電源ユニットに接続する手段と、
を備え、前記第一電極を接続する手段を、前記医療用デバイスの断面積を前記第一電極を接続する手段の断面積で除算した商で示される断面積比が0.75〜4の範囲になるように浸漬した医療用デバイスに接続させる、装置。 - 前記第一電極を接続する手段が、接続される医療用デバイスと同じ材料で与えられる、請求項34に記載の装置。
- 前記第一電極を接続する手段が、平均直径が5mm未満の円形の断面を有する、請求項34又は35に記載の装置。
- 前記第一電極を接続する手段がワイヤーとして与えられる、請求項34〜36のいずれか一項に記載の装置。
- 前記第一電極を接続する手段が少なくとも一部、スレッドで与えられる、請求項34〜37のいずれか一項に記載の装置。
- 好ましくはキャップとして具現化される電場を適合させる手段が与えられる、請求項34〜38のいずれか一項に記載の装置。
- 前記コロイド分散系へのガス供給が与えられる、請求項34〜39のいずれか一項に記載の装置。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US18326109P | 2009-06-02 | 2009-06-02 | |
DE102009023459.4 | 2009-06-02 | ||
US61/183,261 | 2009-06-02 | ||
DE102009023459.4A DE102009023459B4 (de) | 2009-06-02 | 2009-06-02 | Osteosynthese mit Nanosilber |
PCT/EP2010/003308 WO2010139451A2 (en) | 2009-06-02 | 2010-06-01 | Osteosynthesis with nano-silver |
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EP (1) | EP2437798B1 (ja) |
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CN (1) | CN102497892B (ja) |
AU (1) | AU2010255982B2 (ja) |
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CA (1) | CA2763946C (ja) |
DE (1) | DE102009023459B4 (ja) |
ES (1) | ES2536781T3 (ja) |
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DE102011121687A1 (de) | 2011-12-14 | 2013-06-20 | Gmbu E.V., Fachsektion Dresden | Verfahren zur Abscheidung von Silber und danach abgeschiedenes Silber |
SI24094B (sl) | 2012-06-15 | 2021-07-30 | Institut "Jožef Stefan" | Kompozitni materiali na osnovi keramične faze in kovine s funkcionalizirano površino, kot okolju prijazni materiali z antibakterijskim delovanjem, metoda priprave in njihova uporaba |
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DE102015115878B4 (de) * | 2015-09-21 | 2018-03-29 | Aap Implantate Ag | Verfahren zur Behandlung einer metallischen Oberfläche und Körper mit einer behandelten metallischen Oberfläche |
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DE102009023459B4 (de) | 2017-08-31 |
RU2011153237A (ru) | 2013-07-20 |
US8652645B2 (en) | 2014-02-18 |
WO2010139451A2 (en) | 2010-12-09 |
BRPI1013015A2 (pt) | 2016-03-29 |
RU2557938C2 (ru) | 2015-07-27 |
CA2763946A1 (en) | 2010-12-09 |
CN102497892A (zh) | 2012-06-13 |
EP2437798A2 (en) | 2012-04-11 |
BRPI1013015B1 (pt) | 2018-09-04 |
US20140332394A2 (en) | 2014-11-13 |
JP2012528612A (ja) | 2012-11-15 |
US20100316686A1 (en) | 2010-12-16 |
PL2437798T3 (pl) | 2015-08-31 |
US20140166493A1 (en) | 2014-06-19 |
ES2536781T3 (es) | 2015-05-28 |
AU2010255982A1 (en) | 2012-01-19 |
AU2010255982B2 (en) | 2014-04-03 |
CA2763946C (en) | 2018-08-21 |
CN102497892B (zh) | 2015-11-25 |
DE102009023459A1 (de) | 2010-12-09 |
WO2010139451A3 (en) | 2011-05-26 |
US20150114840A2 (en) | 2015-04-30 |
EP2437798B1 (en) | 2015-03-18 |
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