JP6333291B2 - 医療機器用部材のための焼結多孔質ポリマーのキャップ - Google Patents
医療機器用部材のための焼結多孔質ポリマーのキャップ Download PDFInfo
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- JP6333291B2 JP6333291B2 JP2015550798A JP2015550798A JP6333291B2 JP 6333291 B2 JP6333291 B2 JP 6333291B2 JP 2015550798 A JP2015550798 A JP 2015550798A JP 2015550798 A JP2015550798 A JP 2015550798A JP 6333291 B2 JP6333291 B2 JP 6333291B2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/20—Gaseous substances, e.g. vapours
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- 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
- A61L31/04—Macromolecular materials
- A61L31/048—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- 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
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/146—Porous materials, e.g. foams or sponges
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/20—Closure caps or plugs for connectors or open ends of tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/3146—Priming, e.g. purging, reducing backlash or clearance
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3202—Devices for protection of the needle before use, e.g. caps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M2005/1401—Functional features
- A61M2005/1403—Flushing or purging
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M2005/3123—Details having air entrapping or venting means, e.g. purging channels in pistons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M2039/0036—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/20—Closure caps or plugs for connectors or open ends of tubes
- A61M2039/205—Closure caps or plugs for connectors or open ends of tubes comprising air venting means
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- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- Vascular Medicine (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Pulmonology (AREA)
- General Chemical & Material Sciences (AREA)
- Surgery (AREA)
- Environmental & Geological Engineering (AREA)
- Dispersion Chemistry (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Materials For Medical Uses (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
Description
本出願は、2012年12月28日に提出した米国仮特許出願第61/746,677号、2012年12月28日に提出した米国仮特許出願第61/746,695号、及び、2013年6月17日に提出した米国仮特許出願第61/835,883号の優先権を主張するものであり、に基づく優先権を享受するものであり、該仮出願は、参照によりその全体が本明細書に取り込まれる。
例えば、蓄尿バッグの中にはバッグ内に通気体を備えたものがあり、また輸液バッグはその一端に通気体を備えている。通気体でバッグの内側と外側の圧力バランスがとれるとともに、液体の流れ抵抗が少なくなるようにしている。しかしながら、バッグに設けられたこれらの通気体の多くは満足のいくものではない。ある場合には、細いチューブ内で液体流をよくしたい場所からはかけ離れた場所に通気体が位置している。このような通気体では、チューブ又はルアーにトラップされた気泡の除去も行われない。現在利用可能な輸液バッグ又は容器には通気体が必要なものがあり、多くの発展途上国では、看護婦らが輸液バッグに針を刺して通気しなければならない。しかし、この操作を行うと空気による汚染の可能性が大きくなる。さらに、通気が要らないバッグであっても、通気をすることで、よりよい液体流が得られる可能性がある。
そのような医療機器には、無針アクセスポート、蓄尿バッグ、及び輸液バッグが挙げられるが、これらに限定されない。多孔質通気体は、その用途の要件に応じて可撓性又は剛性であってよい。
多孔質キャップ材料
多孔質キャップの実施形態
多孔質通気体
多孔質通気体の構造及び材料
多孔質キャップ及び多孔質通気体のための焼結多孔質可塑性媒体に使用可能な熱可塑性材料
多孔質キャップ及び多孔質通気体のための焼結多孔質エラストマー媒体に使用してよいエラストマー材料
多孔質キャップ及び多孔質通気体のための、プラスチック粒子とエラストマー粒子とを含む焼結多孔質媒体
多孔質キャップ及び多孔質通気体のための焼結多孔質プラスチック及びエラストマー媒体に組み込んでよい抗菌物質
多孔質キャップ又は多孔質通気体の作製方法
キャップ又は通気体に使用される焼結多孔質媒体の特性
指示薬
吸収性添加剤
機能及び用途
多孔質通気体の機能
実施例1
キャップ及び通気体に使用するための各種焼結多孔質媒体の空気流(Gurley)及び細菌ろ過効率(BFE)
添加剤クロルヘキシジン(CHX)を含む焼結多孔質媒体の抗菌特性
エチレンオキサイド抵抗性比較試験
調製段階の設定値:
温度:54.0°C
初期負圧:1.3重量ポンド毎平方インチ絶対圧力(psia)
相対湿度(RH):50%
湿度設定値:2.4psia
蒸気膨張時間:60分
暴露段階設定値:
温度:54.0°C
滅菌剤設定値:7.8psia
EO濃度:600mg/L
ガス滞留時間:5分、15分、30分、60分、90分、及び180分
Claims (17)
- 医療機器の開口部をカバーするためのデバイスであって、
該デバイスは、多孔質閉鎖端と一体化しているデバイス共同端を有する焼結多孔質キャ
ップ本体を含み、
該焼結多孔質キャップ本体の全体が、該キャップ本体の形状の型で焼結される実質的に
均一な混合物を生成するプラスチック粒子およびエラストマー粒子の組み合わせを含み、
該多孔質キャップは、滅菌ガスが該多孔質キャップを通過することができるように焼結
した後、10%〜約90%の空隙率を有し、
多孔質閉鎖端は、使用時に医療機器の開口部の物理的カバーとなり、
該多孔質キャップは、ASTMの試験法2101に基づく95%超の細菌ろ過効率を有
し、そして、
空気流が、TAPPIのT460試験法を用いて測定したときガーレー秒数200秒未
満である、該デバイス。 - 抗菌添加剤、変色指示薬、防腐性材料、吸収性材料、又はこれらの組み合わせをさらに
含む、請求項1に記載のデバイス。 - 前記多孔質キャップを、アクセスポートへねじ止めする、延伸させてアクセスポートに
被せる、又は摩擦力で嵌合させてアクセスポートへ差し込むよう構成する、請求項1に記
載のデバイス。 - 前記多孔質キャップは、該多孔質キャップを介して滅菌ガスが通過し、前記医療機器の
前記一部に接触することを可能にする、請求項1に記載のデバイス。 - 前記医療機器が液体アクセスポートである、請求項1に記載のデバイス。
- 前記液体アクセスポートがルアー取付具又はコネクターを有する、請求項5に記載のデ
バイス。 - 前記液体アクセスポートを血管内ライン、脳血管ライン、消化器ライン、末梢挿入型中
心カテーテル、尿道カテーテル、ドレナージチューブ、シャント、PEGチューブ、PE
G−Jチューブ、経鼻胃管若しくは気管チューブ又は別のチューブに接続する、請求項5
に記載のデバイス。 - 前記多孔質キャップが前記医療機器への微生物の侵入を阻止し、
それにより前記医療機器の微生物汚染を遅らせる又は阻止する、先行する請求項1〜7の
いずれかに記載のデバイス。 - 焼結プラスチック粒子、焼結エラストマー粒子または両者の平均細孔径が約1μm〜約
200μmの範囲である、請求項1に記載のデバイス。 - 焼結プラスチック粒子、焼結エラストマー粒子または両者の密度が約0.1g/cm3
〜約1g/cm3の範囲である、請求項1に記載のデバイス。 - 前記焼結プラスチック粒子がポリオレフィンを含有する、請求項1に記載のデバイス。
- 前記ポリオレフィンが、ポリエチレン、超高分子量ポリエチレン又は高密度ポリエチレ
ンを含む、請求項11に記載のデバイス。 - 請求項1に記載のデバイスを前記医療機器の少なくとも一部に適用することを含
む、医療機器を微生物汚染から保護する方法。 - 医療機器の消毒方法であって、
請求項1〜12いずれかに記載のデバイスを、前記医療機器の少なくとも一部
に被せる又は挿入し、
前記多孔質キャップを介して防腐剤を吸い上げ、
前記防腐剤を前記医療機器の外面又は内面に送達すること
を含む、消毒方法。 - 請求項1に記載のデバイスを前記医療機器に適用し、前記医療機器を包装体内部に置き
、前記医療機器を滅菌ガスで滅菌することを含む、医療機器の微生物汚染を阻止する又は
遅らせる方法。 - 前記デバイスをアクセス所望時に前記医療機器から取り外すこと、前記医療機器にアク
セスすること、及び前記デバイスを前記医療機器に戻すこと、をさらに含む、請求項13
に記載の方法。 - 前記医療機器が、液体アクセスポート、コネクター、ライン、カテーテル、又は、血管
内ライン、脳室用ライン、消化器ライン、末梢挿入型中心カテーテル、尿道カテーテル、
ドレナージチューブ、シャント、PEGチューブ、PEG−Jチューブ、経鼻胃管、及び
気管内チューブからなる群から選択されるチューブである、先行する請求項1〜12のい
ずれかに記載のデバイス。
Applications Claiming Priority (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201261746695P | 2012-12-28 | 2012-12-28 | |
US201261746677P | 2012-12-28 | 2012-12-28 | |
US61/746,695 | 2012-12-28 | ||
US61/746,677 | 2012-12-28 | ||
US201361835883P | 2013-06-17 | 2013-06-17 | |
US61/835,883 | 2013-06-17 | ||
PCT/US2013/077984 WO2014106047A1 (en) | 2012-12-28 | 2013-12-27 | Sintered porous polymeric caps and vents for components of medical devices |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2018035359A Division JP2018108430A (ja) | 2012-12-28 | 2018-02-28 | 医療機器用部材のための焼結多孔質ポリマーのキャップ |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2016507278A JP2016507278A (ja) | 2016-03-10 |
JP2016507278A5 JP2016507278A5 (ja) | 2017-02-09 |
JP6333291B2 true JP6333291B2 (ja) | 2018-05-30 |
Family
ID=50029224
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
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JP2015550798A Expired - Fee Related JP6333291B2 (ja) | 2012-12-28 | 2013-12-27 | 医療機器用部材のための焼結多孔質ポリマーのキャップ |
JP2018035359A Pending JP2018108430A (ja) | 2012-12-28 | 2018-02-28 | 医療機器用部材のための焼結多孔質ポリマーのキャップ |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
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JP2018035359A Pending JP2018108430A (ja) | 2012-12-28 | 2018-02-28 | 医療機器用部材のための焼結多孔質ポリマーのキャップ |
Country Status (5)
Country | Link |
---|---|
US (1) | US9533136B2 (ja) |
EP (1) | EP2938374B1 (ja) |
JP (2) | JP6333291B2 (ja) |
CN (1) | CN105142699A (ja) |
WO (1) | WO2014106047A1 (ja) |
Families Citing this family (42)
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US8252247B2 (en) | 2008-05-06 | 2012-08-28 | Ferlic Michael J | Universal sterilizing tool |
US9572904B2 (en) | 2008-05-06 | 2017-02-21 | Michael J. Ferlic | Sterilizing device with pinch actuated cap and housing |
US10220419B2 (en) | 2012-02-17 | 2019-03-05 | Rymed Technologies, Llc | Integrated cleaning and disinfection device, system and method |
JP6333291B2 (ja) * | 2012-12-28 | 2018-05-30 | ポレックス コーポレーション | 医療機器用部材のための焼結多孔質ポリマーのキャップ |
WO2014160911A1 (en) * | 2013-03-28 | 2014-10-02 | Bayer Medical Care Inc. | Sterility enhanced closure for a fluid path |
US9170205B2 (en) * | 2013-09-18 | 2015-10-27 | Metrex Research, LLC | Disinfection and cleaning confirmation system |
US20150090030A1 (en) * | 2013-09-27 | 2015-04-02 | Infineon Technologies Ag | Transducer arrangement comprising a transducer die and method of covering a transducer die |
EP3114158A1 (en) | 2014-03-07 | 2017-01-11 | Ticona LLC | Sintered polymeric particles having narrow particle size distribution for porous structures |
US9427691B2 (en) * | 2014-03-14 | 2016-08-30 | Pti Technologies, Inc. | Antimicrobial air filter |
ES2749925T3 (es) | 2014-04-24 | 2020-03-24 | Lucira Health Inc | Detección colorimétrica de amplificación de ácido nucleico |
CA164922S (en) * | 2015-04-21 | 2016-06-07 | Bayer Pharma AG | Tamper evident cap for prefilled syringe |
EP3305229A4 (en) | 2015-06-01 | 2019-02-20 | Olympus Corporation | MEDICAL MANIPULATOR |
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WO2014106047A1 (en) | 2014-07-03 |
CN105142699A (zh) | 2015-12-09 |
EP2938374B1 (en) | 2018-10-03 |
EP2938374A1 (en) | 2015-11-04 |
US20140188089A1 (en) | 2014-07-03 |
US9533136B2 (en) | 2017-01-03 |
JP2016507278A (ja) | 2016-03-10 |
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