WO2011113114A1 - Diagnostic system - Google Patents

Diagnostic system Download PDF

Info

Publication number
WO2011113114A1
WO2011113114A1 PCT/AU2011/000315 AU2011000315W WO2011113114A1 WO 2011113114 A1 WO2011113114 A1 WO 2011113114A1 AU 2011000315 W AU2011000315 W AU 2011000315W WO 2011113114 A1 WO2011113114 A1 WO 2011113114A1
Authority
WO
WIPO (PCT)
Prior art keywords
diagnostic system
lancet
composite diagnostic
test material
composite
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.)
Ceased
Application number
PCT/AU2011/000315
Other languages
English (en)
French (fr)
Inventor
John Michael Kelly
Eric Siu
Alison Ruth Norcott
Christopher David Dunn
Ian Frederick Johnson
Ernesto Monis Hueso
Richard Sokolov
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.)
Atomo Diagnostics Ltd
Original Assignee
Atomo Diagnostics Ltd
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 AU2010901175A external-priority patent/AU2010901175A0/en
Priority to AU2011229159A priority Critical patent/AU2011229159C1/en
Priority to PL11755574T priority patent/PL2547259T3/pl
Priority to CN201180024714.0A priority patent/CN103002805B/zh
Priority to SG2012068318A priority patent/SG184077A1/en
Priority to RU2012142139A priority patent/RU2606110C2/ru
Priority to KR1020127027179A priority patent/KR101821557B1/ko
Priority to NZ602912A priority patent/NZ602912A/en
Priority to BR112012023562-1A priority patent/BR112012023562B1/pt
Application filed by Atomo Diagnostics Ltd filed Critical Atomo Diagnostics Ltd
Priority to US13/635,903 priority patent/US20130131479A1/en
Priority to JP2013500285A priority patent/JP6104792B2/ja
Priority to ES11755574.8T priority patent/ES2553251T7/es
Priority to EP11755574.8A priority patent/EP2547259B3/en
Priority to CA2793554A priority patent/CA2793554C/en
Publication of WO2011113114A1 publication Critical patent/WO2011113114A1/en
Anticipated expiration legal-status Critical
Priority to US13/838,145 priority patent/US9295987B2/en
Priority to ZA2013/04196A priority patent/ZA201304196B/en
Priority to US15/083,839 priority patent/US10525463B2/en
Ceased legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5023—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
    • 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
    • A61B5/145—Measuring 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
    • 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
    • A61B5/150206—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
    • A61B5/150343—Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes
    • 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
    • A61B5/150358—Strips for collecting blood, e.g. absorbent
    • 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
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • 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
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150503—Single-ended needles
    • 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
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150541—Breakable protectors, e.g. caps, shields or sleeves, i.e. protectors separated destructively, e.g. by breaking a connecting area
    • A61B5/150549—Protectors removed by rotational movement, e.g. torsion or screwing
    • 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
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/15058—Joining techniques used for protective means
    • A61B5/150618—Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
    • 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
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150694—Procedure for removing protection means at the time of piercing
    • A61B5/150717—Procedure for removing protection means at the time of piercing manually removed
    • 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
    • A61B5/150007—Details
    • A61B5/150801—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming
    • A61B5/150824—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming by visual feedback
    • 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
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15103—Piercing procedure
    • A61B5/15107—Piercing being assisted by a triggering mechanism
    • A61B5/15111—Semi-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
    • 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
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15103—Piercing procedure
    • A61B5/15107—Piercing being assisted by a triggering mechanism
    • A61B5/15113—Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
    • 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
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15115—Driving 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
    • A61B5/15117—Driving 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
    • 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
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15142—Devices intended for single use, i.e. disposable
    • A61B5/15144—Devices intended for single use, i.e. disposable comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
    • 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
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186—Devices 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
    • 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
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186—Devices 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
    • A61B5/15188—Constructional features of reusable driving devices
    • A61B5/15192—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0295—Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring 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
    • A61B5/14532—Measuring 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
    • 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
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/06—Fluid handling related problems
    • B01L2200/0605—Metering of fluids
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/16—Reagents, handling or storing thereof
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/14—Means for pressure control
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0475—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure

Definitions

  • physiologically acceptable solution is brought into contact with the test material along with the bodily fluid.
  • system further comprises an adhesive bandage feature located on a surface or within the support member, adapted, for associating an adhesive bandage with the system.
  • adhesive bandage feature comprises a depression or recessed enclosure to house and retain the bandage.
  • system is sized to be hand-held. In one form the system is adapted to be held in a single hand. In one form the system is adapted for self testing.
  • a composite diagnostic system further comprising an interface element adapted to - allow the system to interface with diagnostic equipment.
  • the interface element comprises a removable portion of the system adapted to engage with diagnostic equipment .
  • Figure 3 shows a second side view of the embodiment of figure 1;
  • Figure 8 shows an isometric view of a third embodiment of the present system
  • Figure 9 shows a side view of the embodiment of figure 8.
  • Figure 12 shows a fourth side view of the embodiment of figure 8;
  • Figure 13 shows a top view of a fourth embodiment of the present system;
  • Figure 14 shows a side view of the embodiment of figure 13
  • Figure 16 shows a .top view of a fifth embodiment of the present system
  • Figure 19 shows a top view of a sixth embodiment of the present system
  • Figure 20 shows a perspective view of the embodiment of figure 19
  • a fluid sample retention material incorporating a fluid sample retention material, an assay, a test strip or an integrated electrical circuit or any material adapted for retaining a sample and allowing a diagnostic test to be performed thereon.
  • the sampling section (183) comprises a sampling body (186) .
  • the sampling body (186) is adapted to be held in one hand, although the body (186) could alternatively be rested on a surface.
  • a membrane penetration element (not illustrated in this form) in the form of a lancet is largely enclosed in the body (186) .
  • a lancet tip (not illustrated) is positioned to extend from the body through a lancet opening (187) in an actuated position and retract back into the body thereafter . Actuation. of the lancet occurs through pressure on a lancet actuation element (188) .
  • test material (not illustrated) is positioned within the body (193) such that fluid from the sampling section (183) interacts with the test material.
  • indicia (72) are incorporated onto the system to visibly cue a user to perform a sequence of steps in order.
  • the indicia are in the form of numbers, however it will be clear that graphic, pictorial,' text or alternative indicia could effectively present the sequence of steps to cue a user.
  • the indicia (72) instruct the user to first perform the step on the side labeled "1", that is, clean and dry the area of skin in preparation for lancing. The user then rotates the system to find step "2", in which the user inserts a finger into the finger pad aperture (29) for lancing. The user then activates the lancet (28) .
  • the diagnostic system is modular, comprising a body incorporating the membrane penetration element and a cartridge, the cartridge incorporating the fluid collection element and test material and, in some forms, a physiologicall . acceptable solution such as a buffer and a test results window.
  • manufacture comprises separately manufacturing the body incorporating, for example, a lancet and the cartridge. Separate manufacture ' allows selection of specific cartridges for use in a given order.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Hematology (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pathology (AREA)
  • Biophysics (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Dermatology (AREA)
  • Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Manufacturing & Machinery (AREA)
  • Analytical Chemistry (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Optics & Photonics (AREA)
  • Emergency Medicine (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)
PCT/AU2011/000315 2010-03-19 2011-03-18 Diagnostic system Ceased WO2011113114A1 (en)

Priority Applications (16)

Application Number Priority Date Filing Date Title
CA2793554A CA2793554C (en) 2010-03-19 2011-03-18 Bodily fluid diagnostic system
PL11755574T PL2547259T3 (pl) 2010-03-19 2011-03-18 Układ diagnostyczny
CN201180024714.0A CN103002805B (zh) 2010-03-19 2011-03-18 诊断系统
SG2012068318A SG184077A1 (en) 2010-03-19 2011-03-18 Diagnostic system
RU2012142139A RU2606110C2 (ru) 2010-03-19 2011-03-18 Диагностическая система
KR1020127027179A KR101821557B1 (ko) 2010-03-19 2011-03-18 진단 시스템
NZ602912A NZ602912A (en) 2010-03-19 2011-03-18 Diagnostic system
BR112012023562-1A BR112012023562B1 (pt) 2010-03-19 2011-03-18 sistema compósito de diagnóstico descartável
US13/635,903 US20130131479A1 (en) 2010-03-19 2011-03-18 Diagnostic system
AU2011229159A AU2011229159C1 (en) 2010-03-19 2011-03-18 Diagnostic system
EP11755574.8A EP2547259B3 (en) 2010-03-19 2011-03-18 Diagnostic system
ES11755574.8T ES2553251T7 (es) 2010-03-19 2011-03-18 Sistema de diagnóstico
JP2013500285A JP6104792B2 (ja) 2010-03-19 2011-03-18 診断システム
US13/838,145 US9295987B2 (en) 2010-03-19 2013-03-15 Integrated testing device
ZA2013/04196A ZA201304196B (en) 2010-03-19 2013-06-07 Diagnostic system
US15/083,839 US10525463B2 (en) 2010-03-19 2016-03-29 Integrated testing device

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AU2010901175 2010-03-19
AU2010901175A AU2010901175A0 (en) 2010-03-19 Diagnostic System

Related Parent Applications (3)

Application Number Title Priority Date Filing Date
PCT/AU2011/000315 Continuation WO2011113114A1 (en) 2010-03-19 2011-03-18 Diagnostic system
US13/635,903 Continuation US20130131479A1 (en) 2010-03-19 2011-03-18 Diagnostic system
PCT/AU2011/001321 Continuation WO2012048388A1 (en) 2010-03-19 2011-10-17 Sampling assembly

Related Child Applications (6)

Application Number Title Priority Date Filing Date
PCT/AU2011/000315 Continuation WO2011113114A1 (en) 2010-03-19 2011-03-18 Diagnostic system
US13/635,903 A-371-Of-International US20130131479A1 (en) 2010-03-19 2011-03-18 Diagnostic system
US13838145 A-371-Of-International 2011-03-18
US13838145 Continuation 2011-03-18
US13/838,145 Continuation US9295987B2 (en) 2010-03-19 2013-03-15 Integrated testing device
US15/083,839 Continuation US10525463B2 (en) 2010-03-19 2016-03-29 Integrated testing device

Publications (1)

Publication Number Publication Date
WO2011113114A1 true WO2011113114A1 (en) 2011-09-22

Family

ID=44648366

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/AU2011/000315 Ceased WO2011113114A1 (en) 2010-03-19 2011-03-18 Diagnostic system

Country Status (18)

Country Link
US (3) US20130131479A1 (https=)
EP (1) EP2547259B3 (https=)
JP (1) JP6104792B2 (https=)
KR (1) KR101821557B1 (https=)
CN (1) CN103002805B (https=)
AU (1) AU2011229159C1 (https=)
BR (1) BR112012023562B1 (https=)
CA (1) CA2793554C (https=)
ES (1) ES2553251T7 (https=)
HU (1) HUE026294T2 (https=)
MY (1) MY174486A (https=)
NZ (1) NZ602912A (https=)
PL (1) PL2547259T3 (https=)
PT (1) PT2547259E (https=)
RU (1) RU2606110C2 (https=)
SG (1) SG184077A1 (https=)
WO (1) WO2011113114A1 (https=)
ZA (1) ZA201304196B (https=)

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019071323A1 (en) 2017-10-12 2019-04-18 Atomo Diagnostics Pty Limited INTEGRATED BLOOD TEST DEVICE
US10595763B2 (en) 2013-11-21 2020-03-24 Atomo Diagnostics Pty Limited Integrated testing devices with control vessel for fluid control
WO2021228819A1 (en) * 2020-05-14 2021-11-18 Owen Mumford Limited Test device
EP3648670B1 (en) * 2017-07-06 2023-01-25 Becton, Dickinson and Company Biological fluid collection device
CN116761550A (zh) * 2020-08-03 2023-09-15 雷纳加德生物公共福利公司 用于采集和测试生物样品的系统和方法
US11877848B2 (en) 2021-11-08 2024-01-23 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
US12023156B2 (en) 2021-10-13 2024-07-02 Satio, Inc. Dermal patch for collecting a physiological sample
US12029562B2 (en) 2021-04-14 2024-07-09 Satio, Inc. Dermal patch system
US12048543B2 (en) 2021-11-08 2024-07-30 Satio, Inc. Dermal patch for collecting a physiological sample with removable vial
US12053284B2 (en) 2021-11-08 2024-08-06 Satio, Inc. Dermal patch for collecting a physiological sample
EP4188220A4 (en) * 2020-08-03 2024-08-14 RenegadeXBio, PBC Systems and methods for acquisition and testing of biological samples
US12178979B2 (en) 2021-10-13 2024-12-31 Satio, Inc. Dermal patch for delivering a pharmaceutical
US12214346B2 (en) 2021-10-13 2025-02-04 Satio, Inc. Dermal patch with a diagnostic test strip
US12611664B2 (en) 2020-05-14 2026-04-28 Owen Mumford Limited Test device

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009197039A (ja) * 2006-08-09 2009-09-03 Asahi Glass Co Ltd 含フッ素共重合体組成物および塗料組成物
JP6695285B2 (ja) * 2014-06-10 2020-05-20 ディクステリティー ダイアグノスティクス インコーポレイテッド 生物学的試料を採取して安定化するためのデバイス及び方法
ES2864412T3 (es) * 2014-07-18 2021-10-13 Becton Dickinson Co Dispositivo de lanceta con retirada de la primera gota
US20170354380A1 (en) * 2016-06-10 2017-12-14 Carydean Enterprises LLC Portable electronic devices and systems for analyzing an analyte
JP6735161B2 (ja) * 2016-06-21 2020-08-05 株式会社日立ハイテク 採血装置および採血装置の作動方法
BR102019009125A2 (pt) * 2019-05-03 2020-11-10 Orangelife Comércio E Indústria Ltda - Me dispositivo cassete para teste rápido de diagnóstico, método para detecção de um ligante em uma amostra biológica e kit
FR3133922B1 (fr) 2022-03-25 2025-07-18 Belmont Diagnostics Dispositif microfluidique d’obtention d’un mélange plasma-réactif et procédé de mise en œuvre
WO2025227193A1 (en) * 2024-04-30 2025-11-06 Ha Tech Pty Ltd Integrated blood testing device

Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4637403A (en) * 1985-04-08 1987-01-20 Garid, Inc. Glucose medical monitoring system
WO1988000812A1 (en) * 1986-07-25 1988-02-11 Garid, Inc. Glucose medical monitoring system
US5249584A (en) * 1990-05-18 1993-10-05 Karkar Maurice N Syringe for hematocrit and oxygen saturation blood analyzer
US5714390A (en) * 1996-10-15 1998-02-03 Bio-Tech Imaging, Inc. Cartridge test system for the collection and testing of blood in a single step
US6264619B1 (en) * 1999-09-01 2001-07-24 Becton, Dickinson And Company Kit for drawing a blood sample
WO2002078533A2 (en) * 2001-03-29 2002-10-10 Inverness Medical Limited Integrated sample testing meter
US20030013121A1 (en) * 2001-07-12 2003-01-16 Khan Waheed N. Diagnostic test kit
WO2004078232A2 (en) * 2003-03-04 2004-09-16 Becton Dickinson And Company Collection device adapted to accept cartridge for point of care system
US20080149333A1 (en) 2006-12-21 2008-06-26 Donald Edward Putzig Process for stabilized zirconium triethanolamine complex and uses in oil field applications
WO2008085052A2 (en) * 2007-01-11 2008-07-17 Arnoldus Huibert Klapwijk Testing device
US20080319347A1 (en) 2007-06-21 2008-12-25 Tomer Keren Diagnostic thimble

Family Cites Families (32)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS594234B2 (ja) 1974-08-31 1984-01-28 三菱重工業株式会社 デンシビ−ムヨウセツホウホウ
US4661319A (en) 1984-04-06 1987-04-28 Boehringer Mannheim Diagnostics, Inc. Blood transfer assembly
JPS61286738A (ja) * 1985-06-14 1986-12-17 オ−デイオバイオニクス　インコ−ポレイテツド 医療用システム
US5096669A (en) * 1988-09-15 1992-03-17 I-Stat Corporation Disposable sensing device for real time fluid analysis
EP1579814A3 (en) * 1996-05-17 2006-06-14 Roche Diagnostics Operations, Inc. Methods and apparatus for sampling and analyzing body fluid
US9155496B2 (en) 1997-03-04 2015-10-13 Dexcom, Inc. Low oxygen in vivo analyte sensor
US6319209B1 (en) 1999-08-23 2001-11-20 European Institute Of Science Disposable test vial with sample delivery device for dispensing sample into a reagent
JP3985022B2 (ja) 1999-11-08 2007-10-03 アークレイ株式会社 体液測定装置、およびこの体液測定装置に挿着して使用する挿着体
US20030028125A1 (en) 2001-08-06 2003-02-06 Yuzhakov Vadim V. Physiological sample collection devices and methods of using the same
JP2003102710A (ja) * 2001-09-30 2003-04-08 Hiroshi Otsuka 血液の分析方法ならびに分析装置
US7303726B2 (en) * 2002-05-09 2007-12-04 Lifescan, Inc. Minimal procedure analyte test system
US20030223906A1 (en) * 2002-06-03 2003-12-04 Mcallister Devin Test strip container system
NZ526334A (en) 2002-06-25 2003-10-31 Bayer Healthcare Llc Sensor with integrated lancet for monitoring blood by colorometric or electrochemical test method
US20040138688A1 (en) * 2002-10-09 2004-07-15 Jean Pierre Giraud Lancet system including test strips and cassettes for drawing and sampling bodily material
US8275437B2 (en) 2003-08-01 2012-09-25 Dexcom, Inc. Transcutaneous analyte sensor
JP2005218855A (ja) * 2004-01-09 2005-08-18 Sysmex Corp 経皮的分析物抽出キット、経皮的分析物抽出装置、血糖値測定装置、経皮的分析物抽出方法及び血糖値測定方法
US7588724B2 (en) * 2004-03-05 2009-09-15 Bayer Healthcare Llc Mechanical device for mixing a fluid sample with a treatment solution
US7766845B2 (en) 2004-06-21 2010-08-03 Roche Diagnostics Operations, Inc. Disposable lancet and lancing cap combination for increased hygiene
US8989833B2 (en) 2004-07-13 2015-03-24 Dexcom, Inc. Transcutaneous analyte sensor
JP2006068384A (ja) * 2004-09-03 2006-03-16 Advance Co Ltd 体液移送具及び体液移送具を用いた体液検査システム
US7488298B2 (en) 2004-10-08 2009-02-10 Roche Diagnostics Operations, Inc. Integrated lancing test strip with capillary transfer sheet
US20070100213A1 (en) * 2005-10-27 2007-05-03 Dossas Vasilios D Emergency medical diagnosis and communications device
CA2657086A1 (en) * 2006-07-06 2008-12-11 Rapidx Ltd Intergrated blood sampling and testing device and method of use thereof
EP2079828A4 (en) * 2006-11-09 2010-03-10 Sense Ltd G SYSTEM AND METHOD FOR PSEUDO-CONTINUOUS MEASUREMENT OF METABOLITE CONCENTRATIONS IN A MAMMALIAN BODY
EP1929937A1 (de) * 2006-12-07 2008-06-11 F. Hoffmann-Roche AG Vorrichtung und Verfahren zum Untersuchen von Körperflüssigkeiten
US7938786B2 (en) 2006-12-13 2011-05-10 Devicor Medical Products, Inc. Vacuum timing algorithm for biopsy device
EP1938756A1 (en) 2006-12-29 2008-07-02 Qiagen GmbH Method and materials for triggered release of a biological sample
EP1970006A1 (de) 2007-03-14 2008-09-17 Roche Diagnostics GmbH Analysesystem zur Bestimmung eines Analyten in einer Körperflüssigkeit und disposibles integriertes Probengewinnungs- und Analyseelement
GB0714351D0 (en) 2007-07-24 2007-09-05 Home Office A Sampling device
US20110152653A1 (en) * 2008-06-05 2011-06-23 G-Sense Ltd. Systems and methods for implementing rapid response monitoring of blood concentration of a metabolite
CN102186590A (zh) 2008-10-17 2011-09-14 布鲁塞尔自由大学 用于用试剂使生物样品脉动和稳定如此脉动的样品的装置、试剂盒和方法
US20110105951A1 (en) * 2009-10-30 2011-05-05 Seventh Sense Biosystems, Inc. Systems and methods for treating, sanitizing, and/or shielding the skin or devices applied to the skin

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4637403A (en) * 1985-04-08 1987-01-20 Garid, Inc. Glucose medical monitoring system
WO1988000812A1 (en) * 1986-07-25 1988-02-11 Garid, Inc. Glucose medical monitoring system
US5249584A (en) * 1990-05-18 1993-10-05 Karkar Maurice N Syringe for hematocrit and oxygen saturation blood analyzer
US5714390A (en) * 1996-10-15 1998-02-03 Bio-Tech Imaging, Inc. Cartridge test system for the collection and testing of blood in a single step
US6264619B1 (en) * 1999-09-01 2001-07-24 Becton, Dickinson And Company Kit for drawing a blood sample
WO2002078533A2 (en) * 2001-03-29 2002-10-10 Inverness Medical Limited Integrated sample testing meter
US20030013121A1 (en) * 2001-07-12 2003-01-16 Khan Waheed N. Diagnostic test kit
WO2004078232A2 (en) * 2003-03-04 2004-09-16 Becton Dickinson And Company Collection device adapted to accept cartridge for point of care system
US20080149333A1 (en) 2006-12-21 2008-06-26 Donald Edward Putzig Process for stabilized zirconium triethanolamine complex and uses in oil field applications
WO2008085052A2 (en) * 2007-01-11 2008-07-17 Arnoldus Huibert Klapwijk Testing device
US20080319347A1 (en) 2007-06-21 2008-12-25 Tomer Keren Diagnostic thimble

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP2547259A4

Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10595763B2 (en) 2013-11-21 2020-03-24 Atomo Diagnostics Pty Limited Integrated testing devices with control vessel for fluid control
EP3648670B1 (en) * 2017-07-06 2023-01-25 Becton, Dickinson and Company Biological fluid collection device
WO2019071323A1 (en) 2017-10-12 2019-04-18 Atomo Diagnostics Pty Limited INTEGRATED BLOOD TEST DEVICE
WO2021228819A1 (en) * 2020-05-14 2021-11-18 Owen Mumford Limited Test device
US12611664B2 (en) 2020-05-14 2026-04-28 Owen Mumford Limited Test device
CN116761550A (zh) * 2020-08-03 2023-09-15 雷纳加德生物公共福利公司 用于采集和测试生物样品的系统和方法
EP4188220A4 (en) * 2020-08-03 2024-08-14 RenegadeXBio, PBC Systems and methods for acquisition and testing of biological samples
US12029562B2 (en) 2021-04-14 2024-07-09 Satio, Inc. Dermal patch system
US12023156B2 (en) 2021-10-13 2024-07-02 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
US12178979B2 (en) 2021-10-13 2024-12-31 Satio, Inc. Dermal patch for delivering a pharmaceutical
US12214346B2 (en) 2021-10-13 2025-02-04 Satio, Inc. Dermal patch with a diagnostic test strip
US12048543B2 (en) 2021-11-08 2024-07-30 Satio, Inc. Dermal patch for collecting a physiological sample with removable vial
US12053284B2 (en) 2021-11-08 2024-08-06 Satio, Inc. Dermal patch for collecting a physiological sample
US12440133B2 (en) 2021-11-08 2025-10-14 Satio, Inc. Dermal patch for collecting a physiological sample
US12446810B2 (en) 2021-11-08 2025-10-21 Satio, Inc. Dermal patch for collecting a physiological sample
US11877848B2 (en) 2021-11-08 2024-01-23 Satio, Inc. Dermal patch for collecting a physiological sample

Also Published As

Publication number Publication date
CA2793554A1 (en) 2011-09-22
AU2011229159A1 (en) 2012-08-16
NZ602912A (en) 2014-07-25
RU2606110C2 (ru) 2017-01-10
EP2547259A1 (en) 2013-01-23
US20130323123A1 (en) 2013-12-05
MY174486A (en) 2020-04-22
ZA201304196B (en) 2015-10-28
US20170001192A1 (en) 2017-01-05
CN103002805A (zh) 2013-03-27
HUE026294T2 (en) 2016-05-30
AU2011229159C1 (en) 2018-01-04
JP2013521953A (ja) 2013-06-13
BR112012023562B1 (pt) 2021-07-06
RU2012142139A (ru) 2014-04-27
CN103002805B (zh) 2015-05-27
US20130131479A1 (en) 2013-05-23
US9295987B2 (en) 2016-03-29
AU2011229159B2 (en) 2012-12-13
ES2553251T3 (es) 2015-12-07
KR101821557B1 (ko) 2018-01-25
CA2793554C (en) 2018-04-03
JP6104792B2 (ja) 2017-03-29
PL2547259T3 (pl) 2016-04-29
EP2547259A4 (en) 2014-03-12
US10525463B2 (en) 2020-01-07
EP2547259B3 (en) 2018-03-21
PT2547259E (pt) 2015-12-01
KR20130057985A (ko) 2013-06-03
ES2553251T7 (es) 2018-04-26
EP2547259B1 (en) 2015-08-19
SG184077A1 (en) 2012-10-30
BR112012023562A2 (pt) 2016-08-02

Similar Documents

Publication Publication Date Title
CA2793554C (en) Bodily fluid diagnostic system
US12082931B2 (en) Blood sampling transfer device
CA2909183C (en) Blood sampling transfer device
EP2627255B1 (en) Sampling assembly
US8628724B2 (en) Integrated needle and test strip with aspiration apparatus and method of use
CA2435439A1 (en) Lancet device having capillary action
JP2009542304A (ja) 統合型採血及び試験器具及びその使用方法
GB2331936A (en) System and method for sampling blood
WO2011026169A1 (en) Sample collecting device
US20240081703A1 (en) Blood collection devices and methods

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 11755574

Country of ref document: EP

Kind code of ref document: A1

DPE1 Request for preliminary examination filed after expiration of 19th month from priority date (pct application filed from 20040101)
WWE Wipo information: entry into national phase

Ref document number: 2011229159

Country of ref document: AU

ENP Entry into the national phase

Ref document number: 2011229159

Country of ref document: AU

Date of ref document: 20110318

Kind code of ref document: A

ENP Entry into the national phase

Ref document number: 2793554

Country of ref document: CA

NENP Non-entry into the national phase

Ref country code: DE

WWE Wipo information: entry into national phase

Ref document number: 1201004801

Country of ref document: TH

Ref document number: 2013500285

Country of ref document: JP

WWE Wipo information: entry into national phase

Ref document number: 2359/MUMNP/2012

Country of ref document: IN

WWE Wipo information: entry into national phase

Ref document number: 2011755574

Country of ref document: EP

ENP Entry into the national phase

Ref document number: 20127027179

Country of ref document: KR

Kind code of ref document: A

WWE Wipo information: entry into national phase

Ref document number: 2012142139

Country of ref document: RU

WWE Wipo information: entry into national phase

Ref document number: 13635903

Country of ref document: US

REG Reference to national code

Ref country code: BR

Ref legal event code: B01A

Ref document number: 112012023562

Country of ref document: BR

ENP Entry into the national phase

Ref document number: 112012023562

Country of ref document: BR

Kind code of ref document: A2

Effective date: 20120918