WO2014088606A8 - Systems, devices, and methods for bodily fluid sample collection and transport - Google Patents

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

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Publication number
WO2014088606A8
WO2014088606A8 PCT/US2013/000268 US2013000268W WO2014088606A8 WO 2014088606 A8 WO2014088606 A8 WO 2014088606A8 US 2013000268 W US2013000268 W US 2013000268W WO 2014088606 A8 WO2014088606 A8 WO 2014088606A8
Authority
WO
WIPO (PCT)
Prior art keywords
sample collection
sample
bodily fluid
fluid sample
devices
Prior art date
Application number
PCT/US2013/000268
Other languages
French (fr)
Other versions
WO2014088606A3 (en
WO2014088606A2 (en
Inventor
Elizabeth A. Holmes
Clarissa LUI
Michael Chen
Daniel Young
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
Priority claimed from US29/466,443 external-priority patent/USD733316S1/en
Priority claimed from US29/466,441 external-priority patent/USD733314S1/en
Priority claimed from US29/466,440 external-priority patent/USD732686S1/en
Priority claimed from US29/466,442 external-priority patent/USD733315S1/en
Priority claimed from US29/466,710 external-priority patent/USD733317S1/en
Priority claimed from US29/466,739 external-priority patent/USD733318S1/en
Priority to EP13860491.3A priority Critical patent/EP2928374B1/en
Priority to AU2013356680A priority patent/AU2013356680A1/en
Priority to JP2015546443A priority patent/JP2016505302A/en
Priority to KR1020157017793A priority patent/KR20150092265A/en
Priority to BR112015012944A priority patent/BR112015012944A2/en
Priority to CN201380072120.6A priority patent/CN104968269B/en
Priority to SG11201504233RA priority patent/SG11201504233RA/en
Application filed by Theranos, Inc. filed Critical Theranos, Inc.
Priority to MX2015007134A priority patent/MX2015007134A/en
Priority to CA2891513A priority patent/CA2891513A1/en
Priority to EP19182034.9A priority patent/EP3666188A1/en
Publication of WO2014088606A2 publication Critical patent/WO2014088606A2/en
Priority to US14/446,080 priority patent/US20140342371A1/en
Priority to US14/447,099 priority patent/US20140358036A1/en
Publication of WO2014088606A3 publication Critical patent/WO2014088606A3/en
Priority to IL239062A priority patent/IL239062A0/en
Priority to US14/737,412 priority patent/US10248765B1/en
Publication of WO2014088606A8 publication Critical patent/WO2014088606A8/en
Priority to HK16103780.0A priority patent/HK1215848A1/en
Priority to AU2018220026A priority patent/AU2018220026A1/en
Priority to US16/275,220 priority patent/US20190287657A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150053—Details 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
    • A61B5/150061—Means for enhancing collection
    • A61B5/150099—Means for enhancing collection by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
    • A61B5/1405—Devices for taking blood samples
    • A61B5/1411—Devices for taking blood samples by percutaneous method, e.g. by lancet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/15003—Source of blood for venous or arterial blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150251—Collection chamber divided into at least two compartments, e.g. for division of samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150305—Packages specially adapted for piercing devices or blood sampling devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150755—Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150977—Arrays of piercing elements for simultaneous piercing
    • A61B5/150984—Microneedles or microblades
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150992—Blood 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, valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A61B5/154—Devices using pre-evacuated means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A61B90/94—Identification means for patients or instruments, e.g. tags coded with symbols, e.g. text
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A61B90/98—Identification means for patients or instruments, e.g. tags using electromagnetic means, e.g. transponders
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • G01N33/491—Blood by separating the blood components
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B10/0051—Devices for taking samples of body liquids for taking saliva or sputum samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90—Identification means for patients or instruments, e.g. tags

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Physics & Mathematics (AREA)
  • Hematology (AREA)
  • Pathology (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Biophysics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medical Informatics (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Manufacturing & Machinery (AREA)
  • Urology & Nephrology (AREA)
  • Medicinal Chemistry (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Ecology (AREA)
  • General Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Food Science & Technology (AREA)
  • Analytical Chemistry (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Electromagnetism (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

Bodily fluid sample collection systems, devices, and method are provided. The device may comprise a first portion comprising at least a sample collection channel configured to draw the fluid sample into the sample collection channel via a first type of motive force. The sample collection device may include a second portion comprising a sample vessel for receiving the bodily fluid sample collected in the sample collection channel, the sample vessel operably engagable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the vessel and/or another source provides a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channel into the vessel.
PCT/US2013/000268 2012-12-05 2013-12-05 Systems, devices, and methods for bodily fluid sample collection and transport WO2014088606A2 (en)

Priority Applications (17)

Application Number Priority Date Filing Date Title
EP19182034.9A EP3666188A1 (en) 2012-12-05 2013-12-05 Systems, devices, and methods for bodily fluid sample collection and transport
CA2891513A CA2891513A1 (en) 2012-12-05 2013-12-05 Systems devices, and methods for bodily fluid sample collection, transport, and handling
MX2015007134A MX2015007134A (en) 2012-12-05 2013-12-05 Systems, devices, and methods for bodily fluid sample collection and transport.
EP13860491.3A EP2928374B1 (en) 2012-12-05 2013-12-05 Device for bodily fluid sample collection
SG11201504233RA SG11201504233RA (en) 2012-12-05 2013-12-05 Systems, devices, and methods for bodily fluid sample collection and transport
CN201380072120.6A CN104968269B (en) 2012-12-05 2013-12-05 For body fluid sample collection, transport and the systems, devices and methods of processing
AU2013356680A AU2013356680A1 (en) 2012-12-05 2013-12-05 Systems, devices, and methods for bodily fluid sample collection and transport
JP2015546443A JP2016505302A (en) 2012-12-05 2013-12-05 Systems, devices, and methods for collecting, transporting and handling bodily fluid samples
KR1020157017793A KR20150092265A (en) 2012-12-05 2013-12-05 Systems, devices, and methods for bodily fluid sample collection and transport
BR112015012944A BR112015012944A2 (en) 2012-12-05 2013-12-05 systems, devices and methods for body fluid sample collection and transport
US14/446,080 US20140342371A1 (en) 2012-12-05 2014-07-29 Bodily Fluid Sample Collection and Transport
US14/447,099 US20140358036A1 (en) 2012-12-05 2014-07-30 Bodily Fluid Sample Collection and Transport
IL239062A IL239062A0 (en) 2012-12-05 2015-05-28 Systems, devices, and methods for bodily fluid sample transport
US14/737,412 US10248765B1 (en) 2012-12-05 2015-06-11 Systems, devices, and methods for bodily fluid sample collection, transport, and handling
HK16103780.0A HK1215848A1 (en) 2012-12-05 2016-04-01 Systems, devices, and methods for bodily fluid sample collection and transport
AU2018220026A AU2018220026A1 (en) 2012-12-05 2018-08-21 Systems, devices, and methods for bodily fluid sample collection and transport
US16/275,220 US20190287657A1 (en) 2012-12-05 2019-02-13 Systems, devices, and methods for bodily fluid sample collection, transport, and handling

Applications Claiming Priority (23)

Application Number Priority Date Filing Date Title
US201261733886P 2012-12-05 2012-12-05
US61/733,886 2012-12-05
US201361852489P 2013-03-15 2013-03-15
US201361786351P 2013-03-15 2013-03-15
US61/852,489 2013-03-15
US61/786,351 2013-03-15
US201361875030P 2013-09-07 2013-09-07
US61/875,030 2013-09-07
US201361875107P 2013-09-08 2013-09-08
US29/466,442 2013-09-08
US29/466,443 USD733316S1 (en) 2013-09-08 2013-09-08 Shipping container
US29/466,443 2013-09-08
US61/875,107 2013-09-08
US29/466,441 USD733314S1 (en) 2013-09-08 2013-09-08 Shipping container
US29/466,440 USD732686S1 (en) 2013-09-08 2013-09-08 Shipping container
US29/466,440 2013-09-08
US29/466,441 2013-09-08
UA29/466,441 2013-09-08
US29/466,442 USD733315S1 (en) 2013-09-08 2013-09-08 Shipping container
US29/466,710 USD733317S1 (en) 2013-09-08 2013-09-10 Shipping container
US29/466,710 2013-09-10
US29/466,739 USD733318S1 (en) 2013-09-08 2013-09-11 Shipping container
US29/466,739 2013-09-11

Related Parent Applications (2)

Application Number Title Priority Date Filing Date
US29/466,440 Continuation-In-Part USD732686S1 (en) 2012-12-05 2013-09-08 Shipping container
US29/466,739 Continuation-In-Part USD733318S1 (en) 2012-12-05 2013-09-11 Shipping container

Related Child Applications (3)

Application Number Title Priority Date Filing Date
US14/446,080 Continuation US20140342371A1 (en) 2012-12-05 2014-07-29 Bodily Fluid Sample Collection and Transport
US14/447,099 Continuation US20140358036A1 (en) 2012-12-05 2014-07-30 Bodily Fluid Sample Collection and Transport
US14/447,099 Continuation-In-Part US20140358036A1 (en) 2012-12-05 2014-07-30 Bodily Fluid Sample Collection and Transport

Publications (3)

Publication Number Publication Date
WO2014088606A2 WO2014088606A2 (en) 2014-06-12
WO2014088606A3 WO2014088606A3 (en) 2014-08-07
WO2014088606A8 true WO2014088606A8 (en) 2015-07-09

Family

ID=50884116

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2013/000268 WO2014088606A2 (en) 2012-12-05 2013-12-05 Systems, devices, and methods for bodily fluid sample collection and transport

Country Status (11)

Country Link
JP (3) JP2016505302A (en)
KR (1) KR20150092265A (en)
CN (2) CN104968269B (en)
AU (2) AU2013356680A1 (en)
BR (1) BR112015012944A2 (en)
CA (1) CA2891513A1 (en)
HK (1) HK1215848A1 (en)
IL (1) IL239062A0 (en)
MX (1) MX2015007134A (en)
SG (1) SG11201504233RA (en)
WO (1) WO2014088606A2 (en)

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AU2013356680A1 (en) 2015-05-28
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