JP6084772B2 - 薬液送達用ペンニードルアセンブリ - Google Patents
薬液送達用ペンニードルアセンブリ Download PDFInfo
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- JP6084772B2 JP6084772B2 JP2011553096A JP2011553096A JP6084772B2 JP 6084772 B2 JP6084772 B2 JP 6084772B2 JP 2011553096 A JP2011553096 A JP 2011553096A JP 2011553096 A JP2011553096 A JP 2011553096A JP 6084772 B2 JP6084772 B2 JP 6084772B2
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- 238000012377 drug delivery Methods 0.000 title 1
- 238000010254 subcutaneous injection Methods 0.000 claims description 22
- 239000007929 subcutaneous injection Substances 0.000 claims description 22
- 239000003814 drug Substances 0.000 claims description 20
- 229940079593 drug Drugs 0.000 claims description 19
- 229940090048 pen injector Drugs 0.000 claims description 14
- 230000000717 retained effect Effects 0.000 claims description 4
- 230000004888 barrier function Effects 0.000 claims description 3
- 230000004927 fusion Effects 0.000 claims description 3
- 239000000356 contaminant Substances 0.000 claims description 2
- 239000002131 composite material Substances 0.000 claims 7
- 230000014759 maintenance of location Effects 0.000 claims 1
- 210000003491 skin Anatomy 0.000 description 47
- 238000002347 injection Methods 0.000 description 22
- 239000007924 injection Substances 0.000 description 22
- 210000004207 dermis Anatomy 0.000 description 6
- 210000002615 epidermis Anatomy 0.000 description 5
- 238000000034 method Methods 0.000 description 5
- 238000007920 subcutaneous administration Methods 0.000 description 5
- 239000000725 suspension Substances 0.000 description 5
- 230000000712 assembly Effects 0.000 description 4
- 238000000429 assembly Methods 0.000 description 4
- 239000002245 particle Substances 0.000 description 3
- 230000002776 aggregation Effects 0.000 description 2
- 230000035515 penetration Effects 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 230000000452 restraining effect Effects 0.000 description 2
- 230000036558 skin tension Effects 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 230000005236 sound signal Effects 0.000 description 2
- 241000282887 Suidae Species 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 238000005054 agglomeration Methods 0.000 description 1
- 238000004220 aggregation Methods 0.000 description 1
- 238000010171 animal model Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000011259 mixed solution Substances 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 230000037452 priming Effects 0.000 description 1
- 238000010079 rubber tapping Methods 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 229920001169 thermoplastic Polymers 0.000 description 1
- 239000004416 thermosoftening plastic Substances 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3494—Trocars; Puncturing needles with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors
- A61B17/3496—Protecting sleeves or inner probes; Retractable tips
-
- 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
- A61M5/329—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 characterised by features of the needle shaft
-
- 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
- A61M5/3293—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 characterised by features of the needle hub
-
- 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
- A61M5/46—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 having means for controlling depth of insertion
-
- 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
- A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
-
- 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
- A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
- A61M5/347—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub rotatable, e.g. bayonet or screw
-
- 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
- A61M5/42—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 having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
- A61M5/425—Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49815—Disassembling
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Hematology (AREA)
- Vascular Medicine (AREA)
- Anesthesiology (AREA)
- Surgery (AREA)
- Pathology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Description
Claims (19)
- ハブと、
前記ハブに固定された針であって、近位端と遠位端を有し、それらの間にルーメンが延びる針と、
を備えるペンニードルアセンブリであって、
前記針は前記ハブから遠位方向に延びて、前記針の前記遠位端と前記ハブの間に、皮下注射を容易にする約5.0から9.0mmの範囲の露出部長さが画定され、かつ前記針は、前記遠位端から近位方向に延びる刃状面を有し、前記ルーメンは前記刃状面に画成された遠位側開口部で終結し、前記針の内の前記刃状面に対応する長さは前記露出部長さの30%から60%の範囲であり、
前記ハブには、前記針の周囲に形成された支柱が画成され、前記支柱は遠位側に面する第一の皮膚係合面を有し、前記針の前記露出部長さは前記第一の皮膚係合面から遠位方向に延び、
前記ハブには、前記第一の皮膚係合面を少なくとも部分的に取り囲む、遠位側に面する第二の皮膚係合面が画成され、前記第二の皮膚係合面は前記第一の皮膚係合面の近位側に位置付けられ、
前記第二の皮膚係合面は、複数の放射状のフィンによって画成され、前記複数のフィンは前記支柱から半径方向の外側に延びて、互いに連結されない外側自由端を有することを特徴とするペンニードルアセンブリ。 - 前記針の大きさが25ゲージまたはそれより大きいことを特徴とする請求項1に記載のペンニードルアセンブリ。
- 前記針の大きさが20から25ゲージの範囲であること特徴とする請求項1に記載のペンニードルアセンブリ。
- 前記第二の皮膚係合面は不連続的であることを特徴とする請求項1に記載のペンニードルアセンブリ。
- 前記第二の皮膚係合面は、前記第一の皮膚係合面の0.07インチから0.10インチの範囲だけ近位側に位置付けられていることを特徴とする請求項1に記載のペンニードルアセンブリ。
- 前記第一の皮膚係合面は、前記針から半径方向に外側に伸び、第一の直径で終結することを特徴とする請求項1に記載のペンニードルアセンブリ。
- 前記第二の皮膚係合面は第二の直径を画定し、前記第一の直径と前記第二の直径の比は0.25から0.58の範囲であることを特徴とする請求項6に記載のペンニードルアセンブリ。
- 前記第一の直径と前記第二の直径の比は0.36であることを特徴とする請求項7に記載のペンニードルアセンブリ。
- 前記第二の皮膚係合面の外側縁辺は前記第二の直径を画定することを特徴とする請求項7に記載のペンニードルアセンブリ。
- 患者に投与するために、内部に収容された薬剤を調製するために振動する必要のある医用ペン型注射器と共に使用する複合体であって、
ハブと、前記ハブに固定された針であって、近位端と遠位端を有し、それらの間にルーメンが延びる針と、を備えるペンニードルアセンブリと、
前記ハブに解放可能に保持されるように構成されたシェルと、
を備え、
前記針は前記ハブから遠位方向に延びて、前記針の前記遠位端と前記ハブの間に、皮下注射を容易にする約5.0から9.0mmの範囲の露出部長さが画定され、かつ前記針は、前記遠位端から近位方向に延びる刃状面を有し、前記ルーメンは前記刃状面に画成された遠位側開口部で終結し、前記針の内の前記刃状面に対応する長さは前記露出部長さの30%から60%の範囲であり、
前記ハブには、前記針の周囲に形成された支柱が画成され、前記支柱は遠位側に面する第一の皮膚係合面を有し、前記針の前記露出部長さは前記第一の皮膚係合面から遠位方向に延び、
前記ハブには、前記第一の皮膚係合面を少なくとも部分的に取り囲む、遠位側に面する第二の皮膚係合面が画成され、前記第二の皮膚係合面は前記第一の皮膚係合面の近位側に位置付けられ、
前記第二の皮膚係合面は、複数の放射状のフィンによって画成され、前記複数のフィンは前記支柱から半径方向の外側に延びて、互いに連結されない外側自由端を有し、
前記シェルは、前記ハブに、前記シェルが前記針の少なくとも一部を覆うように保持され、前記保持の力は、前記ペンニードルアセンブリが医用ペン型注射器に取り付けられて、患者に投与するために、内部に収容された薬剤を調製するために医用ペン型注射器が振動される際に、前記ハブに前記シェルが保持されたままの状態とするのに十分に大きいことを特徴とする複合体。 - 前記解放可能な保持は、摩擦係合、破砕型結合、機械的結合、融着および接着からなる集合の内の1つまたは1つ以上によって得られることを特徴とする請求項10に記載の複合体。
- 前記シェルは、前記ペンニードルアセンブリを収容するように形成された内部を有するカップ型胴体を含むことを特徴とする請求項10に記載の複合体。
- 前記カップ型胴体は、前記ペンニードルアセンブリが前記胴体の中に挿入される範囲を限定するように構成された、直径の小さい領域を前記内部の中に画成する肩部を含むことを特徴とする請求項12に記載の複合体。
- 前記肩部は、前記ハブの一部との間隙が最小限となり、前記肩部からの汚染物質の進入を制限するように構成されることを特徴とする請求項13に記載の複合体。
- 前記胴体は遠位端を有し、前記遠位端は、前記ペンニードルアセンブリが前記胴体の中に収容されたときに、前記針から離間されることを特徴とする請求項12に記載の複合体。
- 前記シェルに取り外し可能に固定され、前記シェルで前記ペンニードルアセンブリの全体を取り囲むようにするバリアシートまたはフィルムをさらに備えることを特徴とする請求項10に記載の複合体。
- 第一および第二の皮膚係合面を有するハブであって、前記第二の皮膚係合面は、前記第一の皮膚係合面を少なくとも部分的に取り囲み、かつ前記第一の皮膚係合面の近位端に位置付けられる、ハブと、
前記ハブに固定された針であって、近位端と遠位端を有し、それらの間にルーメンが延びる針と、
を備えるペンニードルアセンブリであって、
前記針は前記ハブから遠位方向に延びて、前記針の前記遠位端と前記ハブの間に、皮下注射を容易にする約5.0から9.0mmの露出部長さが画定され、
前記針は、前記遠位端から近位方向に延びる刃状面を有し、前記ルーメンは前記刃状面に画成された遠位側開口部で終結し、前記針の内、前記刃状面に対応する長さは、前記露出部長さの30%から60%の範囲であり、
前記第二の皮膚係合面は、複数の放射状のフィンによって画成され、前記複数のフィンは、前記ハブに画成されて前記針の周囲に形成された支柱から半径方向の外側に延びて、互いに連結されない外側自由端を有することを特徴とするペンニードルアセンブリ。 - 前記針の大きさが25ゲージまたはそれより大きいことを特徴とする請求項17に記載のペンニードルアセンブリ。
- 前記針の大きさが20から25ゲージの範囲であることを特徴とする請求項17に記載のペンニードルアセンブリ。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US20905009P | 2009-03-03 | 2009-03-03 | |
US61/209,050 | 2009-03-03 | ||
PCT/US2010/026129 WO2010102067A2 (en) | 2009-03-03 | 2010-03-03 | Pen needle assembly for delivering drug solutions |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
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JP2015181188A Division JP6272281B2 (ja) | 2009-03-03 | 2015-09-14 | 薬液送達用ペンニードルアセンブリ |
Publications (3)
Publication Number | Publication Date |
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JP2012519546A JP2012519546A (ja) | 2012-08-30 |
JP2012519546A5 JP2012519546A5 (ja) | 2013-04-18 |
JP6084772B2 true JP6084772B2 (ja) | 2017-02-22 |
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JP2011553096A Active JP6084772B2 (ja) | 2009-03-03 | 2010-03-03 | 薬液送達用ペンニードルアセンブリ |
JP2015181188A Active JP6272281B2 (ja) | 2009-03-03 | 2015-09-14 | 薬液送達用ペンニードルアセンブリ |
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JP2015181188A Active JP6272281B2 (ja) | 2009-03-03 | 2015-09-14 | 薬液送達用ペンニードルアセンブリ |
Country Status (6)
Country | Link |
---|---|
US (3) | US9445838B2 (ja) |
EP (3) | EP3488885B1 (ja) |
JP (2) | JP6084772B2 (ja) |
CN (1) | CN102413858B (ja) |
ES (2) | ES2718828T3 (ja) |
WO (1) | WO2010102067A2 (ja) |
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CN202822353U (zh) * | 2009-12-22 | 2013-03-27 | 贝克顿·迪金森公司 | 具有能够移动的锁定舌的安全针组件 |
EP2552521A1 (en) * | 2010-03-26 | 2013-02-06 | Sanofi-Aventis Deutschland GmbH | Dedicated needle assembly |
EP3881876A1 (en) | 2011-08-01 | 2021-09-22 | Alcyone Lifesciences, Inc. | Microfluidic drug delivery devices |
US9224945B2 (en) | 2012-08-30 | 2015-12-29 | Micron Technology, Inc. | Resistive memory devices |
US9919129B2 (en) | 2012-12-18 | 2018-03-20 | Alcyone Lifesciences, Inc. | Systems and methods for reducing or preventing backflow in a delivery system |
ES2712691T3 (es) | 2012-12-26 | 2019-05-14 | Becton Dickinson Co | Envase de aguja de pluma |
JP6599771B2 (ja) | 2012-12-26 | 2019-10-30 | ベクトン・ディキンソン・アンド・カンパニー | ペン針アセンブリ |
EP2783721A1 (en) * | 2013-03-26 | 2014-10-01 | Sanofi-Aventis Deutschland GmbH | Needle assembly retainer |
US10456533B2 (en) | 2013-06-17 | 2019-10-29 | Alcyone Lifesciences, Inc. | Methods and devices for protecting catheter tips and stereotactic fixtures for microcatheters |
AU2014296183B2 (en) | 2013-07-31 | 2019-03-14 | Alcyone Therapeutics, Inc. | Systems and methods for drug delivery, treatment, and monitoring |
CN110420368B (zh) * | 2013-10-18 | 2021-10-08 | 赛诺菲-安万特德国有限公司 | 注射装置 |
USD770043S1 (en) * | 2013-10-29 | 2016-10-25 | Htl-Strefa Spolka Akcyjna | Needle hub |
USD768850S1 (en) * | 2013-10-29 | 2016-10-11 | Htl-Strefa Spolka Akcyjna | Needle shield |
US11577030B2 (en) * | 2013-12-04 | 2023-02-14 | Embecta Corp. | Pen needle attachment mechanisms |
WO2015085031A1 (en) * | 2013-12-04 | 2015-06-11 | Becton, Dickinson And Company | Pen needle attachment mechanisms |
USD751192S1 (en) * | 2014-05-14 | 2016-03-08 | Health Line International Corp. | Medical device |
US10806396B2 (en) | 2015-01-26 | 2020-10-20 | Alcyone Lifesciences, Inc. | Drug delivery methods with tracer |
ES2937021T3 (es) | 2015-01-30 | 2023-03-23 | Embecta Corp | Concentrador de aguja de pluma con una superficie de contacto con el paciente |
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CN102413858A (zh) | 2012-04-11 |
ES2877190T3 (es) | 2021-11-16 |
EP3488885A3 (en) | 2019-08-21 |
EP2403572A2 (en) | 2012-01-11 |
JP2016005725A (ja) | 2016-01-14 |
WO2010102067A2 (en) | 2010-09-10 |
CN102413858B (zh) | 2017-03-01 |
US9445838B2 (en) | 2016-09-20 |
EP3488885A2 (en) | 2019-05-29 |
WO2010102067A3 (en) | 2011-01-13 |
EP3488885B1 (en) | 2021-04-28 |
JP6272281B2 (ja) | 2018-01-31 |
US20190117261A1 (en) | 2019-04-25 |
US20140188046A1 (en) | 2014-07-03 |
EP2403572B1 (en) | 2019-01-16 |
US10441730B2 (en) | 2019-10-15 |
US20120109052A1 (en) | 2012-05-03 |
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