JP2019531843A - 医用装置を滅菌する方法 - Google Patents
医用装置を滅菌する方法 Download PDFInfo
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Abstract
Description
・プロピレングリコールを没食子酸プロピルに添加し、ついで、食塩水または蒸留水を添加すること:高速反応(没食子酸プロピルの高速溶解)
・ 食塩水/蒸留水を没食子酸プロピルに添加し、ついで、プロピレングリコールを添加すること:低速反応(没食子酸プロピルの低速溶解)
・プロピレングリコールを食塩水/蒸留水に添加し、ついで、没食子酸プロピルを添加すること:高速反応(没食子酸プロピルの高速溶解)
・プロピレングリコールの代わりにグリセロールを使用すること:低速反応(没食子酸プロピルの低速溶解)。
・医用装置を設けること;
・医用装置を少なくとも部分的に機能的コーティング剤で被覆すること;
・ 機能的コーティング剤の劣化を防止するか遅延させる組成物に医用装置を接触させることによって、医用装置の機能的コーティング剤を活性化させること;
・医用装置および組成物を耐蒸発性の包装容器に包装すること。
a.締付け力=300g
b.テスト速度=180mm/分
c.テスト距離=60mm
d.繰り返す摩擦テストサイクル=25
e.速度=3cm/秒
Na−CMC=カルボキシメチルセルロースナトリウム
PPG=プロピレングリコール
DW=蒸留水
・濃度が0.2wt%のPGは十分な安定度だけをもたらす(試料2)。
・超音波撹拌によって、PG溶解能が向上する(試料1および3)。
・比較的低比率である1:1のPG対Na−CMCは、十分なコーティング安定性を発揮する(試料4)。
Claims (20)
- 機能的コーティング剤を備えたすぐに使える医用装置を製造する方法であって、
・ 少なくともその機能的コーティング剤を備えた医用装置を、その機能的コーティング剤の劣化を防ぐか遅延させる組成物と接触させるステップと、
・ 前記医用装置および前記組成物を放射線によって滅菌するステップと、を含み、
前記組成物は、カルボキシメチルセルロースあるいはその誘導体または塩、および/または没食子酸またはその誘導体から選択される酸化防止剤を備える、方法。 - 前記組成物の没食子酸の誘導体が、没食子酸のエステル誘導体、アミド誘導体、またはオキサジアゾール誘導体である、請求項1に記載の方法。
- 没食子酸またはその誘導体が前記組成物にあり、前記組成物の全重量を基準として、0.001〜5重量パーセントである、請求項1または2に記載の方法。
- 前記組成物が、カルボキシメチルセルロースのナトリウム塩を含む、請求項1に記載の方法。
- カルボキシメチルセルロースまたはその誘導体またはその塩が、前記組成物の全重量を基準として、0.1〜10重量パーセントである、請求項1または4に記載の方法。
- 前記組成物が、カルボキシメチルセルロース、あるいはその誘導体または塩、および、没食子酸、または没食子酸のエステル誘導体、アミド誘導体、またはオキサジアゾール誘導体から選択されるその誘導体で、より好ましくは没食子酸プロピルである、請求項1、4、または5に記載の方法。
- 没食子酸またはその誘導体が、前記組成物の全重量を基準として、0.001〜1重量パーセントである、請求項6に記載の方法。
- 前記組成物が、エンハンサ溶液を含む、請求項1から7のいずれかに記載の方法。
- 前記組成物が、水または油を基剤とした基礎液、または、脂質媒質、またはその組み合わせをさらに含む、請求項1から8のいずれかに記載の方法。
- 前記組成物の水性溶液が、蒸留水、脱イオン水、逆浸透水、濾水、または食塩水から選択される、請求項9に記載の方法。
- 水性溶液が、組成物中に、組成物の全重量を基準として、50〜99.9重量パーセントの量で存在する、請求項9または10に記載の方法。
- 前記組成物が、安定剤および/または緩衝液を含む、請求項1から11のいずれかに記載の方法。
- 前記エンハンサ溶液がエチレングリコール、ジエチレングリコール、プロピレングリコール、またはグリセロールから選択され、前記組成物の全重量を基準として、0.1〜49。8重量パーセントの量で存在する、請求項8から11のいずれかに記載の方法。
- 前記緩衝液のpHが2.0〜7.4である、請求項12または13に記載の方法。
- 放射線滅菌中の放射線のエネルギ線量が、1〜50kGy、好ましくは15〜45kGy、より好ましくは25〜45kGyの範囲内にある、請求項1から14のいずれかに記載の方法。
- 以下のステップを含む、請求項1から15のいずれかに記載の方法:
・医用装置を設けること;
・医用装置を少なくとも部分的に機能的コーティング剤で被覆すること;
・ 機能的コーティング剤の劣化を防止するか遅延させる組成物に医用装置を接触させることによって、医用装置の機能的コーティング剤を活性化させること;
・医用装置および組成物を耐蒸発性の包装容器に包装すること。 - 前記医用装置が、カテーテル(1;21)を含む、請求項1から16のいずれかに記載の方法。
- 前記機能的コーティング剤が、親水性コーティング剤である、請求項1から17のいずれかに記載の方法。
- 前記カテーテル(1;21)が、カテーテル・シャフト(2;22)を含み、カテーテル・シャフト(2;22)は少なくともその挿入可能な長さ部に沿って親水性コーティング剤で被覆されており、伸縮式スリーブ(7;27)によって堅固に包囲されており、伸縮式スリーブ(7;27)および/またはカテーテル(1;21)は液密の閉止部が遠位端(5;25)と近位端(6;26)にあるので、前記伸縮式スリーブ(7;27)またはカテーテル・シャフト(2;22)にある任意の液体は、液密の閉止部が破壊されない限り、伸縮式スリーブ(7;27)およびカテーテルに残存する、請求項17または18に記載の方法。
- 請求項1から19に記載の方法における、カルボキシメチルセルロースあるいはその誘導体または塩、および/または没食子酸またはその誘導体から選択される酸化防止剤を備える組成物を含む湿潤剤の使用。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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EP16001766.1A EP3281649A1 (en) | 2016-08-09 | 2016-08-09 | Wetting agent formulation |
EP16001766.1 | 2016-08-09 | ||
PCT/EP2017/070249 WO2018029279A1 (en) | 2016-08-09 | 2017-08-09 | Method for sterilizing a medical device |
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JP2019531843A true JP2019531843A (ja) | 2019-11-07 |
JP6886021B2 JP6886021B2 (ja) | 2021-06-16 |
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Application Number | Title | Priority Date | Filing Date |
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JP2019529691A Active JP6886021B2 (ja) | 2016-08-09 | 2017-08-09 | 医用装置を滅菌する方法 |
JP2019529313A Active JP6893557B2 (ja) | 2016-08-09 | 2017-08-09 | 医用装置コーティング剤の平滑潤滑性劣化防止用組成物、医用装置コーティング剤の平滑潤滑性劣化防止用組成物の使用、および医用装置コーティング剤の平滑潤滑性劣化防止用湿潤剤 |
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JP2019529313A Active JP6893557B2 (ja) | 2016-08-09 | 2017-08-09 | 医用装置コーティング剤の平滑潤滑性劣化防止用組成物、医用装置コーティング剤の平滑潤滑性劣化防止用組成物の使用、および医用装置コーティング剤の平滑潤滑性劣化防止用湿潤剤 |
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US (3) | US20190216985A1 (ja) |
EP (3) | EP3281649A1 (ja) |
JP (2) | JP6886021B2 (ja) |
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WO (2) | WO2018028831A1 (ja) |
Families Citing this family (4)
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EP4176908A1 (en) | 2018-05-17 | 2023-05-10 | Hollister Incorporated | Methods of making sleeved hydrophilic catheter assemblies |
US11819590B2 (en) * | 2019-05-13 | 2023-11-21 | Surmodics, Inc. | Apparatus and methods for coating medical devices |
EP4185360A1 (en) * | 2020-08-03 | 2023-05-31 | C. R. Bard, Inc. | Intermittent-catheter assemblies |
EP4349390A2 (en) * | 2021-03-23 | 2024-04-10 | Wellspect AB | Reusable hydrophilic urinary catheter assembly |
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Also Published As
Publication number | Publication date |
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JP6893557B2 (ja) | 2021-06-23 |
EP3496773A1 (en) | 2019-06-19 |
JP6886021B2 (ja) | 2021-06-16 |
AU2020204093A1 (en) | 2020-07-09 |
EP3496772A1 (en) | 2019-06-19 |
AU2017309310B2 (en) | 2019-10-31 |
US20190216985A1 (en) | 2019-07-18 |
US11524096B2 (en) | 2022-12-13 |
US20230105383A1 (en) | 2023-04-06 |
AU2017309310A1 (en) | 2019-02-21 |
AU2017309652A1 (en) | 2019-02-28 |
JP2019526403A (ja) | 2019-09-19 |
US20190167849A1 (en) | 2019-06-06 |
WO2018029279A1 (en) | 2018-02-15 |
EP3281649A1 (en) | 2018-02-14 |
WO2018028831A1 (en) | 2018-02-15 |
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