JP6058063B2 - 試料採取デバイスインタフェース - Google Patents

試料採取デバイスインタフェース Download PDF

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Publication number
JP6058063B2
JP6058063B2 JP2015085864A JP2015085864A JP6058063B2 JP 6058063 B2 JP6058063 B2 JP 6058063B2 JP 2015085864 A JP2015085864 A JP 2015085864A JP 2015085864 A JP2015085864 A JP 2015085864A JP 6058063 B2 JP6058063 B2 JP 6058063B2
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JP
Japan
Prior art keywords
fluid
skin
article
subject
vacuum
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Expired - Fee Related
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JP2015085864A
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English (en)
Japanese (ja)
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JP2015154966A5 (enExample
JP2015154966A (ja
Inventor
イー. チッカーリング ザ サード ドナルド
イー. チッカーリング ザ サード ドナルド
デイビス ショーン
デイビス ショーン
ハグーイ ラミン
ハグーイ ラミン
バーンスタイン ハワード
バーンスタイン ハワード
エー. レビンソン ダグラス
エー. レビンソン ダグラス
Original Assignee
セブンス センス バイオシステムズ,インコーポレーテッド
セブンス センス バイオシステムズ,インコーポレーテッド
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Publication of JP2015154966A publication Critical patent/JP2015154966A/ja
Publication of JP2015154966A5 publication Critical patent/JP2015154966A5/ja
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848Needles
    • A61B5/6849Needles in combination with a needle set
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14532Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/150022Source of blood for capillary blood or interstitial fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150053Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150061Means for enhancing collection
    • A61B5/150099Means for enhancing collection by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150221Valves
    • AHUMAN NECESSITIES
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    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150229Pumps for assisting the blood sampling
    • AHUMAN NECESSITIES
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    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150236Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
    • AHUMAN NECESSITIES
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    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150244Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
    • AHUMAN NECESSITIES
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    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150274Manufacture or production processes or steps for blood sampling devices
    • A61B5/150297Manufacture or production processes or steps for blood sampling devices for piercing devices, i.e. devices ready to be used for lancing or piercing
    • AHUMAN NECESSITIES
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    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150389Hollow piercing elements, e.g. canulas, needles, for piercing the skin
    • AHUMAN NECESSITIES
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    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150412Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • AHUMAN NECESSITIES
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    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150503Single-ended needles
    • AHUMAN NECESSITIES
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    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150755Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
    • AHUMAN NECESSITIES
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    • A61B5/15Devices for taking samples of blood
    • A61B5/150969Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150977Arrays of piercing elements for simultaneous piercing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150977Arrays of piercing elements for simultaneous piercing
    • A61B5/150984Microneedles or microblades
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101Details
    • A61B5/15103Piercing procedure
    • A61B5/15105Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101Details
    • A61B5/15103Piercing procedure
    • A61B5/15107Piercing being assisted by a triggering mechanism
    • A61B5/15113Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101Details
    • A61B5/15115Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
    • A61B5/15117Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101Details
    • A61B5/15115Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
    • A61B5/15125Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising a vacuum or compressed fluids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15142Devices intended for single use, i.e. disposable
    • A61B5/15144Devices intended for single use, i.e. disposable comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/157Devices characterised by integrated means for measuring characteristics of blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/685Microneedles

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Pathology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Hematology (AREA)
  • Manufacturing & Machinery (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Emergency Medicine (AREA)
  • Optics & Photonics (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • External Artificial Organs (AREA)
  • Surgical Instruments (AREA)
JP2015085864A 2010-01-13 2015-04-20 試料採取デバイスインタフェース Expired - Fee Related JP6058063B2 (ja)

Applications Claiming Priority (12)

Application Number Priority Date Filing Date Title
US29454310P 2010-01-13 2010-01-13
US61/294,543 2010-01-13
US33452910P 2010-05-13 2010-05-13
US33453310P 2010-05-13 2010-05-13
US61/334,529 2010-05-13
US61/334,533 2010-05-13
US35758210P 2010-06-23 2010-06-23
US61/357,582 2010-06-23
US36760710P 2010-07-26 2010-07-26
US61/367,607 2010-07-26
US37376410P 2010-08-13 2010-08-13
US61/373,764 2010-08-13

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
JP2012549079A Division JP5826766B2 (ja) 2010-01-13 2011-01-13 試料採取デバイスインタフェース

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2015218347A Division JP2016039972A (ja) 2010-01-13 2015-11-06 試料採取デバイスインタフェース

Publications (3)

Publication Number Publication Date
JP2015154966A JP2015154966A (ja) 2015-08-27
JP2015154966A5 JP2015154966A5 (enExample) 2015-12-24
JP6058063B2 true JP6058063B2 (ja) 2017-01-11

Family

ID=54262469

Family Applications (5)

Application Number Title Priority Date Filing Date
JP2015085864A Expired - Fee Related JP6058063B2 (ja) 2010-01-13 2015-04-20 試料採取デバイスインタフェース
JP2015094065A Expired - Fee Related JP6254545B2 (ja) 2010-01-13 2015-05-01 流体の急速送達および/また採取
JP2015185244A Pending JP2016027878A (ja) 2010-01-13 2015-09-18 流体の急速送達および/また採取
JP2015218347A Pending JP2016039972A (ja) 2010-01-13 2015-11-06 試料採取デバイスインタフェース
JP2017172050A Pending JP2018011975A (ja) 2010-01-13 2017-09-07 流体の急速送達および/また採取

Family Applications After (4)

Application Number Title Priority Date Filing Date
JP2015094065A Expired - Fee Related JP6254545B2 (ja) 2010-01-13 2015-05-01 流体の急速送達および/また採取
JP2015185244A Pending JP2016027878A (ja) 2010-01-13 2015-09-18 流体の急速送達および/また採取
JP2015218347A Pending JP2016039972A (ja) 2010-01-13 2015-11-06 試料採取デバイスインタフェース
JP2017172050A Pending JP2018011975A (ja) 2010-01-13 2017-09-07 流体の急速送達および/また採取

Country Status (4)

Country Link
US (6) US20180242890A1 (enExample)
EP (1) EP3243435A1 (enExample)
JP (5) JP6058063B2 (enExample)
CN (1) CN107115115B (enExample)

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US10638963B2 (en) 2017-01-10 2020-05-05 Drawbridge Health, Inc. Devices, systems, and methods for sample collection
US11266337B2 (en) 2015-09-09 2022-03-08 Drawbridge Health, Inc. Systems, methods, and devices for sample collection, stabilization and preservation

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US9295417B2 (en) 2011-04-29 2016-03-29 Seventh Sense Biosystems, Inc. Systems and methods for collecting fluid from a subject
EP2408372B1 (en) 2009-03-02 2019-01-09 Seventh Sense Biosystems, Inc. Devices associated with blood sampling
US20130158482A1 (en) 2010-07-26 2013-06-20 Seventh Sense Biosystems, Inc. Rapid delivery and/or receiving of fluids
US20120039809A1 (en) 2010-08-13 2012-02-16 Seventh Sense Biosystems, Inc. Systems and techniques for monitoring subjects
ES2565805T3 (es) 2010-11-09 2016-04-07 Seventh Sense Biosystems, Inc. Sistemas e interfaces para el muestreo de sangre
AU2012249683A1 (en) 2011-04-29 2013-11-14 Seventh Sense Biosystems, Inc. Devices and methods for collection and/or manipulation of blood spots or other bodily fluids
US20130158468A1 (en) 2011-12-19 2013-06-20 Seventh Sense Biosystems, Inc. Delivering and/or receiving material with respect to a subject surface
KR102237667B1 (ko) 2011-04-29 2021-04-12 세븐쓰 센스 바이오시스템즈, 인크. 유체들의 전달 및/또는 수용
US8535241B2 (en) 2011-10-13 2013-09-17 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
US9060724B2 (en) 2012-05-30 2015-06-23 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
US9022950B2 (en) 2012-05-30 2015-05-05 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
WO2014022275A1 (en) 2012-08-01 2014-02-06 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
ES2878047T3 (es) 2012-10-11 2021-11-18 Magnolia Medical Technologies Inc Sistema para administrar un fluido a un paciente con contaminación reducida
US10772548B2 (en) 2012-12-04 2020-09-15 Magnolia Medical Technologies, Inc. Sterile bodily-fluid collection device and methods
CN104981203B (zh) 2012-12-04 2017-12-08 木兰医药技术股份有限公司 无菌体液采集装置和方法
EP4218574A3 (en) 2016-11-18 2023-09-06 Magnolia Medical Technologies, Inc. Systems and methods for sample collection with reduced hemolysis
JP7273807B2 (ja) 2017-06-09 2023-05-15 マグノリア メディカル テクノロジーズ,インコーポレイテッド 流体制御デバイス及びそれを使用する方法
JP7204742B2 (ja) 2017-09-12 2023-01-16 マグノリア メディカル テクノロジーズ,インコーポレイテッド 流体制御デバイス及び流体制御デバイスを使用する方法
CN118986346A (zh) * 2018-05-01 2024-11-22 贝克顿·迪金森公司 收集生物流体样品的方法和生物流体收集装置
CN109199400B (zh) * 2018-09-10 2021-08-31 中山大学 基于微针阵列的血糖电化学传感器
US20220221405A1 (en) * 2019-05-28 2022-07-14 Robert A. Levine Apparatus and method for transferring and analyzing suspended particles in a liquid sample
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US20210059588A1 (en) * 2019-08-30 2021-03-04 Tasso, Inc. Bodily fluid collection devices and related methods
FR3108837B1 (fr) * 2020-04-06 2022-03-11 Pkvitality Dispositif de mesure d’analyte comprenant un patch adhesif
CN115734798A (zh) 2020-04-28 2023-03-03 提克纳有限责任公司 微针组件
CA3203391A1 (en) * 2020-12-30 2022-07-07 Song Li Methods and devices for inducement of sweat for medical diagnostics
US12214346B2 (en) 2021-10-13 2025-02-04 Satio, Inc. Dermal patch with a diagnostic test strip
US11452474B1 (en) * 2021-04-14 2022-09-27 Satio, Inc. Dual lever dermal patch system
US11510602B1 (en) * 2021-11-08 2022-11-29 Satio, Inc. Dermal patch for collecting a physiological sample
US11964121B2 (en) 2021-10-13 2024-04-23 Satio, Inc. Mono dose dermal patch for pharmaceutical delivery
US11877848B2 (en) * 2021-11-08 2024-01-23 Satio, Inc. Dermal patch for collecting a physiological sample
US12053284B2 (en) * 2021-11-08 2024-08-06 Satio, Inc. Dermal patch for collecting a physiological sample
US12178979B2 (en) 2021-10-13 2024-12-31 Satio, Inc. Dermal patch for delivering a pharmaceutical
US12023156B2 (en) 2021-10-13 2024-07-02 Satio, Inc. Dermal patch for collecting a physiological sample
US12048543B2 (en) * 2021-11-08 2024-07-30 Satio, Inc. Dermal patch for collecting a physiological sample with removable vial
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US20230320662A1 (en) 2023-10-12
US20180310884A1 (en) 2018-11-01
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US20180242890A1 (en) 2018-08-30
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JP2016039972A (ja) 2016-03-24
CN107115115A (zh) 2017-09-01
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