CA2993316A1 - Systems, devices, and methods for bodily fluid sample collection, transport, and handling - Google Patents

Systems, devices, and methods for bodily fluid sample collection, transport, and handling Download PDF

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Publication number
CA2993316A1
CA2993316A1 CA2993316A CA2993316A CA2993316A1 CA 2993316 A1 CA2993316 A1 CA 2993316A1 CA 2993316 A CA2993316 A CA 2993316A CA 2993316 A CA2993316 A CA 2993316A CA 2993316 A1 CA2993316 A1 CA 2993316A1
Authority
CA
Canada
Prior art keywords
sample
vessels
location
channels
vessel
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
CA2993316A
Other languages
English (en)
French (fr)
Inventor
Elizabeth Holmes
Clarissa LUI
Michael Chen
Daniel Young
Samartha ANEKAL
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Theranos Inc
Original Assignee
Theranos Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Theranos Inc filed Critical Theranos Inc
Publication of CA2993316A1 publication Critical patent/CA2993316A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/49Blood
    • G01N33/491Blood by separating the blood components
    • 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
    • A61B5/150015Source of blood
    • A61B5/15003Source of blood for venous or arterial blood
    • 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
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • 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
    • A61B5/150251Collection chamber divided into at least two compartments, e.g. for division of samples
    • 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
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150305Packages specially adapted for piercing devices or blood sampling 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
    • A61B5/150007Details
    • A61B5/150351Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel
    • 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
    • A61B5/150755Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
    • 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
    • A61B5/150763Details with identification means
    • A61B5/150793Electrical or magnetic identification means
    • 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
    • A61B5/150992Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; Blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings or valves
    • 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
    • A61B5/15109Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
    • 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
    • A61B5/15111Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
    • 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
    • A61B5/153Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A61B5/154Devices using pre-evacuated means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5021Test tubes specially adapted for centrifugation purposes
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • G01N1/28Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G01N1/40Concentrating samples
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • G01N1/28Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G01N1/40Concentrating samples
    • G01N1/4077Concentrating samples by other techniques involving separation of suspended solids
    • 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
    • A61B5/150374Details 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
    • 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
    • A61B5/150374Details 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
    • 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
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150572Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
    • 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
    • A61B5/150732Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube
    • 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
    • A61B5/150801Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming
    • A61B5/150824Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming by visual feedback
    • 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
    • A61B5/150954Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
    • 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
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L9/00Supporting devices; Holding devices
    • B01L9/06Test-tube stands; Test-tube holders
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • G01N1/28Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G01N1/40Concentrating samples
    • G01N1/4077Concentrating samples by other techniques involving separation of suspended solids
    • G01N2001/4083Concentrating samples by other techniques involving separation of suspended solids sedimentation

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pathology (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Medical Informatics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Clinical Laboratory Science (AREA)
  • Manufacturing & Machinery (AREA)
  • Pain & Pain Management (AREA)
  • Dermatology (AREA)
  • Diabetes (AREA)
  • Ecology (AREA)
  • Urology & Nephrology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
CA2993316A 2015-07-21 2016-07-21 Systems, devices, and methods for bodily fluid sample collection, transport, and handling Abandoned CA2993316A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562195287P 2015-07-21 2015-07-21
US62/195,287 2015-07-21
PCT/US2016/043435 WO2017015517A1 (en) 2015-07-21 2016-07-21 Systems, devices, and methods for bodily fluid sample collection, transport, and handling

Publications (1)

Publication Number Publication Date
CA2993316A1 true CA2993316A1 (en) 2017-01-26

Family

ID=57834733

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2993316A Abandoned CA2993316A1 (en) 2015-07-21 2016-07-21 Systems, devices, and methods for bodily fluid sample collection, transport, and handling

Country Status (6)

Country Link
EP (1) EP3325160A4 (enExample)
JP (2) JP2018528411A (enExample)
CN (1) CN108025308A (enExample)
CA (1) CA2993316A1 (enExample)
MX (1) MX2018000944A (enExample)
WO (1) WO2017015517A1 (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2025083614A1 (en) * 2023-10-19 2025-04-24 Vital Biosciences Inc. Devices, systems, and methods for optical analysis of biological samples

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20200182862A1 (en) * 2017-06-16 2020-06-11 DRK-Blutspendedienst Baden-Württemberg-Hessen gGmbH Method and apparatus for single tube blood donor screening
EP3673449A1 (en) * 2018-02-15 2020-07-01 Smart4Diagnostics Gmbh Smart system for sample surveillance and management
CN111939994A (zh) * 2019-05-14 2020-11-17 重庆好德译信息技术有限公司 一种保温式内分泌科用积液送检试管及其保温方法
CN111289601B (zh) * 2020-02-20 2020-12-01 四川大学 一种提高水体中溶解气体浓度测量准确性的方法
CN111760608B (zh) * 2020-06-25 2022-04-15 杭州慈平医疗器械有限公司 一种检验科用检验后血液样本处理装置
JP7461646B2 (ja) * 2020-07-17 2024-04-04 株式会社アラクス 検査器具
CN113262164B (zh) * 2021-06-07 2022-05-17 吉林大学 一种输血袋血型确认装置
US20230397856A1 (en) * 2022-06-06 2023-12-14 Rhinostics Inc. Automation compatible collection device for biological fluids

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US3679129A (en) * 1970-09-08 1972-07-25 Technicon Instr Blood sample tray apparatus
WO2000061256A1 (en) * 1999-04-12 2000-10-19 Harvest Technologies Corporation Method and apparatus for producing platelet rich plasma and/or platelet concentrate
US6905612B2 (en) * 2003-03-21 2005-06-14 Hanuman Llc Plasma concentrate apparatus and method
US7845499B2 (en) * 2002-05-24 2010-12-07 Biomet Biologics, Llc Apparatus and method for separating and concentrating fluids containing multiple components
EP1662987B1 (en) 2003-09-11 2011-11-09 Theranos, Inc. Medical device for analyte monitoring and drug delivery
EP3756767B1 (en) 2007-10-02 2024-05-01 Labrador Diagnostics LLC Modular point-of-care devices and uses thereof
CN103906429B (zh) * 2011-05-03 2015-09-02 汾沃有限公司 血小板的重悬浮方法和装置
US8380541B1 (en) 2011-09-25 2013-02-19 Theranos, Inc. Systems and methods for collecting and transmitting assay results
US10012664B2 (en) * 2011-09-25 2018-07-03 Theranos Ip Company, Llc Systems and methods for fluid and component handling
BR112015005028B1 (pt) * 2012-09-06 2020-12-15 Theranos Ip Company, Llc Sistema, dispositivos e métodos para a coleta de amostras de fluídos corporais
CN104968269B (zh) * 2012-12-05 2019-02-15 赛拉诺斯知识产权有限责任公司 用于体液样品收集、运输和处理的系统、装置和方法
US9386948B2 (en) * 2012-12-05 2016-07-12 Theranos, Inc. Systems, devices, and methods for bodily fluid sample transport

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2025083614A1 (en) * 2023-10-19 2025-04-24 Vital Biosciences Inc. Devices, systems, and methods for optical analysis of biological samples

Also Published As

Publication number Publication date
EP3325160A4 (en) 2019-04-03
JP2021099372A (ja) 2021-07-01
EP3325160A1 (en) 2018-05-30
CN108025308A (zh) 2018-05-11
WO2017015517A1 (en) 2017-01-26
MX2018000944A (es) 2018-08-29
JP2018528411A (ja) 2018-09-27

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