WO1998058260A1 - Device for determination of an analyte in a body fluid - Google Patents

Device for determination of an analyte in a body fluid Download PDF

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Publication number
WO1998058260A1
WO1998058260A1 PCT/US1998/011407 US9811407W WO9858260A1 WO 1998058260 A1 WO1998058260 A1 WO 1998058260A1 US 9811407 W US9811407 W US 9811407W WO 9858260 A1 WO9858260 A1 WO 9858260A1
Authority
WO
WIPO (PCT)
Prior art keywords
layer
reagent
support member
spreading layer
spreading
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/US1998/011407
Other languages
English (en)
French (fr)
Inventor
Joel S. Douglas
Ryszard Radwanski
Brent G. Duchon
John H. Priest
David A. Hasker
John M. Gleisner
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.)
Mercury Diagnostics Inc
Original Assignee
Mercury Diagnostics 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 Mercury Diagnostics Inc filed Critical Mercury Diagnostics Inc
Priority to JP50448299A priority Critical patent/JP2002510392A/ja
Priority to AU82530/98A priority patent/AU8253098A/en
Priority to DE69836272T priority patent/DE69836272T2/de
Priority to EP98932712A priority patent/EP0993614B1/en
Publication of WO1998058260A1 publication Critical patent/WO1998058260A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • G01N33/521—Single-layer analytical elements
    • 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
    • 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
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • G01N33/525—Multi-layer analytical elements
    • 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
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/026—Fluid interfacing between devices or objects, e.g. connectors, inlet details
    • 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
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0825—Test strips
    • 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
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0887—Laminated structure
    • 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
    • B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
    • B01L2400/0406—Moving fluids with specific forces or mechanical means specific forces capillary forces
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/805—Test papers
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/81—Packaged device or kit
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/97—Test strip or test slide
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S436/00—Chemistry: analytical and immunological testing
    • Y10S436/805—Optical property
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S436/00—Chemistry: analytical and immunological testing
    • Y10S436/807—Apparatus included in process claim, e.g. physical support structures
    • Y10S436/81—Tube, bottle, or dipstick

Definitions

  • reagent strip containing a dry chemistry reagent system, that is, a system in which the wet chemistries are imbibed into an absorbent or bibulous medium, dried, and later reconstituted by fluid from the test sample.
  • the reagent strips contain an indicator which changes color, depending on the presence or concentration of a particular analyte in a biological fluid applied to the strip. These strips may be read visually by reference to a color standard or colorimetrically by instrument calibrated or programmed to detect a certain color.
  • strips use reduction chemistries, more commonly they involve an oxidizable dye or dye couple.
  • Some of the strips include an enzyme, such as glucose oxidase, which is capable of oxidizing glucose to gluconic acid and hydrogen peroxide. They also contain an oxidizable dye and a substance having peroxidative activity, which is capable of selectively catalyzing oxidation of the oxidizable dye in the presence of hydrogen peroxide.
  • 3,607,093 discloses a membrane for testing blood where the membrane has a skin permeable to solutions but impermeable to solids such as red blood cells and to macromolecules such as proteins. This membrane is disclosed as being used by applying a blood sample then wiping away the red blood cells from the skin in order to reach die test indication through the skin.
  • Phillips et al. U.S. Pat. No. 4,935,346 discloses a system wherein a whole blood sample is applied to the device and indicator development occurs in the presence of the colored components of the sample. Measurements of the color change in indicator are made at two distinct wavelengths to eliminate the interferences from the presence of colored blood components.
  • Terminello et al. U.S. Pat. No. 4,774,192, disclose a system in which the matrix is formed of an asymmetric material used to filter the red blood cells in the sample.
  • the asymmetric material has a density gradient from one side to the other to progressively separate red blood cells from the fluids.
  • Daffern et al. U.S. Pat. No. 4,994,238, disclose a test device that comprises an asymmetric reagent layer that has progressively finer filtration with increased distance from one surface toward the other surface.
  • this invention provides a method of testing body fluids for the presence or concentration of an analyte by using a porous matrix.
  • International patent application WO 97/38126 published October 16, 1997 describes the use of microporous matrix material and the concept of microtitration which are well suited for use in this invention, the disclosure of which application is incorporated herein by reference.
  • this invention provides a device that contains body fluids during testing that eliminates the problems of meter contamination, and it's simple colorimetric design greatly reduces the difficulties of manufacturing and cost.
  • this invention uses the concept of microtitration to limit the volume of the sample thereby improving the accuracy of the test.
  • the capillary wick and/or the membrane is bounded to the injection molded capillary and handle thereby creating a defined volume for the absorption of the sample.
  • the user applies a blood sample to the capillary by placing the capillary tube in communication with the sample and allowing it to wick up the tube and wet out the membrane.
  • the fluid passes through the capillary spreading layer/filter onto the membrane.
  • the reading or measuring for the presence/concentration of the analyte being tested is accomplished by detecting the change in reflectance of the reagents which are imbibed into the membrane.
  • the embodiments of the devices of the invention with the appropriate dry chemistry system in the matrix member can be used in test strips which may be read or measured in an electronic meter.
  • this invention provides a method of testing a fluid for the presence or concentration of an analyte comprising providing a test strip comprising a support member; a spreading layer on the first side of the support member; a reagent layer on the spreading layer which comprises a reagent selected for the analyte of interest; and a capillary tube on the opposite side of the support member communicating through an aperture in the support member with the spreading layer, whereby a fluid containing an analyte introduced into the tube flows through the tube and the spreading layer to contact the reagent; introducing sufficient fluid containing an analyte into the capillary tube to flow onto the reagent layer; and observing or measuring the indication of the reagent.
  • the method includes preassembling the carrier layer, the reagent layer and the spreading layer; and mounting the preassembled layer on the support member.
  • Figure 1 is a perspective view of the capillary tube test strip assembly of this invention.
  • Figure 2 is a perspective view of the injection molded capillary tube and support member including a handle.
  • Figure 3 is a perspective view of the spreading/filtering layer.
  • Figure 4 is a perspective view of the reagent bearing membrane and carrier member.
  • Figure 7 is a perspective bottom view of an alternate capillary tube and support member, including handle, which provides barriers to define a specific volume for the microtitration.
  • Figure 8 is a perspective view of a compressed embossed spreading/filtering layer which fits into Figure 7.
  • Figure 9 is a perspective view of the capillary tube test strip assembly of this invention with sensors molded into the capillary tube for detection of the presence of and sequential flow of liquid through the tube.
  • the devices of the present invention are simpler to use and are easier and less costly to manufacture than most devices previously available.
  • the simplicity of use is especially important for diabetics who rely on blood glucose testing multiple times per day to keep their disease under control.
  • the costs associated with blood glucose monitoring are also important, especially elderly diabetics on fixed incomes.
  • Devices of various configurations and various uses based on the embodiments of the invention disclosed herein can be delivered to the diabetic, in a more cost effective manner.
  • the ease of use and ability to capture the blood sample provide a means to use non traditional sites on the body from which to extract a sample. This eliminates the need for the patient to continually use the finger tips as a sampling site.
  • One membrane used in the invention is preferably a polyethersulfone polymer, which is cast to inherently have a microporous skin on one side and a porous matrix on the other side, such as the Gelman membrane.
  • a matrix layer or membrane having uniform porosity but no barrier skin on either side by laminating to one side of such a matrix a microporous barrier film to form the required barrier skin on one side of the matrix may also employ a matrix layer or membrane having uniform porosity but no barrier skin on either side by laminating to one side of such a matrix a microporous barrier film to form the required barrier skin on one side of the matrix.
  • the invention provides different mechanisms for using the dry chemistry reagent systems with or without microtitration volume control.
  • the dry chemistry components and microtitration principles which are described below and in the above referenced International patent application WO 97/38126, are well suited for this application, and are independent of the device embodiments which follow.
  • the preferred method for controlling the test area geometry is to emboss or compress the capillary wick or spreading layer and membrane or reagent layer into the molded part, deforming a portion of the capillary wick and membrane into openings in the molded part and leaving the test area uncompressed.
  • the molded part comprises the capillary tube, support member, optional handle, and preferably a recessed area molded to receive the capillary wick and the membrane.
  • the compressed areas are fastened to the molded part with adhesive such as 3-M grade 415 acrylic pressure sensitive adhesive, creating a test area which is completely bounded on the sides, preventing any flow outside the area.
  • the capillary tube and capillary wick or spreading layer are embossed into the molded part by bringing both pieces together and pressing them together which pushes a portion of the capillary wick and membrane into the gasket openings and deforms the material outside of the openings by compressing it so that the thickness is reduced by 80 to 95 % in the compressed portion.
  • a preferred material is dimethylsiloxane ethylene oxide, part number PS073 from United Chemical Technologies.
  • the same effect may be achieved through the use of patterned hydrophilic printing inks, BSI Corporation PhotolinkTM hydrophilic surface treatment or by using a Cellulosic injection molded part. These materials work equally well. Selection of a polymer having hydrophilic surface properties may eliminate need for any wetting agents.
  • the above reagents will create a chemistry which can be read with a meter.
  • the separation reagents, indicator reagents, oxidase enzymes, peroxidase enzymes, hematocrit adjuster, buffers, and chelators together with the dye system are impregnated in the membrane matrix forming the reagent layer.
  • the issue of hematocrit level affecting the accuracy of test results is a substantial one for a test device.
  • the following embodiment of this invention can be used to compensate for the hematocrit variation of whole blood.
  • the instrument can be designed with additional sensors. These sensors can either be electrical contacts or light sources and receivers (sensors) connected to analog signaling/conditioning circuit. These additional sensors can be implemented so that they inspect the capillary tubes in the test device, one sensor at the beginning of the capillary channel and one at the end.
  • Whole blood is applied to the capillary.
  • the entry flow of whole blood is timed as it moves between sensors.
  • the time that the blood takes to travel the length of the tube capillary is an indication of the hematocrit of the blood. That information is used to correct any shift in reflectance readings of the instrument caused by the hematocrit level.
  • the capillary test strip 1 is shown in Figure 1 and comprises of five components.
  • the first part is the injection molded capillary tube 2 and support member 3 which comprises capillary tube 2, handle portion 15, vent holes 8 and 9, and slot or recess 16.
  • the second component is the spreading/filtering layer 4 which is in communication with the membrane or reagent layer 5.
  • the reagent layer membrane 5 is attached to a carrier layer 6 by adhesive layer 7.
  • the adhesive layer 7 also attaches the carrier layer 6 to the support member 3.
  • Figure 2 shows a detail perspective view of the injection molded capillary tube 2 and support member 3 which has capillary mbe 2, handle area 15, vent holes 8 and 9, and slot 16 molded therein.
  • the sample is wicked into the capillary tube 2.
  • the materials which can be used to mold capillary tube 2 and support member 3 are selected for their wetability (hydrophilic) properties. These materials include polycarbonate, cellulosics and combinations of these with incorporated or added wetting agents such as polydimethylsiloxanes prepared as copolymers with alkene oxides. These materials are sold by United Chemical Technologies, Inc. Bristol, PA USA.
  • the capillary tube inside diameter dimensions are selected such mat adequate sample is drawn by capillary action into the device and can range from less than 0.001 inches to 0.100 inches in diameter depending on the type of sample fluid and the inside diameter appropriate for capillary drawing of a particular sample fluid.
  • Figure 3 shows the spreading layer/ filter layer 4.
  • This layer has high capillary action to draw the liquid sample into the device, transferring the sample to reagent layer membrane 5.
  • the material of layer 4 is selected so that it can provide three beneficial purposes. The first is to provide capillary action to help draw the sample through the capillary tube 2. This provides the mechanism to empty the tube of the collected sample and disperse it onto the reagent layer membrane 5.
  • a secondary function is to provide a filtering mechanism or pretreatment for the sample. Materials which have been proven to provide adequate capillary action are Ahlstrom 1281, 1660 and 1661. These materials are sold by Ahlstrom Filtration of Mt. Holly Springs, PA USA.
  • the third benefit of the spreading layer 4 is it provides a light filter, i.e.
  • FIG. 4 shows the reagent layer membrane 5 which is attached to the carrier layer 6 by adhesive layer 7. This subassembly is used to support the membrane reagent layer 5 during manufacture and provide protection for me fragile membrane 5.
  • the membrane 5 has a reagent indicator system mixture applied to it to facilitate the indication of the presence or concentration of an analyte.
  • the membrane which is preferred is Pall Gelman Sciences Supor 200, a polyethersulfone.
  • the carrier layer 6 is preferably made from 0.005 inch thick polystyrene. However, any appropriate membrane or reagent layer material 5 can be used and the carrier layer or material 6 can be fashioned from a wide range of polymers or sheet material.
  • Figure 5 shows the carrier layer 6 and membrane 5 subassembly from the opposite side illustrating an embodiment with a test window or aperture 10.
  • Figure 6 is an exploded view showing all the components in Figures 2 through 5 and how they are assembled to form the device of Figure 1.
  • the adhesive 7 is used to attach the carrier 6 and membrane 5 to the support member 3.
  • Figure 8 shows spreading layer/filter 17 after it has been deformed into the shape conforming to the barrier members 11 and 12.
  • This layer can include both spreading layer 4 laminated with reagent layer 5 to form element 17.
  • the reagent layer 5 can be smaller in size so it fits between barrier members 11 and 12 so it is not deformed with spreading layer 4.
  • Figure 9 shows the capillary test strip with sensors 19 and 20 molded into the capillary tube for use as explained above.
  • the membrane material or reagent layer, 5 such as illustrated in Figure 6, will generally be in the ranges of about 0.003" to 0.007" in thickness. In most test devices a thickness of about 0.004" to 0.005" is preferred.
  • the carrier layer 6 in Figure 6 will generally be a_ polymeric strip having a thickness from about 0.005" to about 0.012" in most applications and depending on the type of polymeric strip employed a thickness of about 0.007" to 0.008" is preferred.
  • the carrier layer 6 is preferable a transparent layer so the reagent layer 5 can be read by a meter through carrier layer 6 without possibility of contamination of the meter.
  • the mbe 2 can be any desired shape, cylindrical, rectangular, square, elliptical, etc., and can be positioned at any position in or on the support member or strip from embedded in same with the mbe end opening at the end or side of the support member or strip to preferably extending from the surface of the support member or strip, for example at an angle from about 15° through 90° relative to the surface of the support member, so long as it functions with layers 4 and 5 (or 17) to wick the desired volume of sample fluid into the device and to the reagent layer.
  • the tube will typically be 0.2" in length with an inside diameter to provide a sample size of less than about 7 microlitre ( ⁇ L), preferably about 1 to 5 ⁇ L, more preferably about 2 to 4 ⁇ L and most preferably about 3 ⁇ L.
  • ⁇ L microlitre
  • the overall thickness of the assembled test strip devices according to this invention may vary according to the desired use.
  • the overall thickness of the assembled devices can range from about 0.006" to about 0.040". Due to the strength provided by laminating the various layers thinner layered materials may be used and provide sufficient strength.
  • the overall thickness of a test strip device according to this invention will be determined also by the necessary and desired thickness of the matrix member to provide sufficient volume absorption.
  • the shape need not be flat, but may be other shape desired for manufacturing efficiency, e.g. , cylindrical, or for ease of handling by the user.
  • the typical composite material having a thickness of about 0.005" to about 0.012" will be compressed at the barrier members 11 and 12 to a thickness of about 0.001" or less and typically less than about 0.0005".
  • the portion of the matrix layer which protrudes into the volumetric opening will remain at or near its full original thickness.
  • the devices of this invention are conveniently made into test strips of convenient size and configuration for use by individuals and in instruments or meters which are adapted to measure the color or other indication provided by the test strips.
  • a material useful for transfer of fluid containing analyte and blocking transfer of solids is a composite cellulose and glass fiber matrix, such as that available from Ahlstrom as part number 1661 or 1662, especially to separate the whole blood into red blood cells and substantially clear fluid.
  • the whole blood is applied to the capillary and wicks into the matrix material.
  • the use of a capillary tube to collect the sample permits the patient to collect a sample from a non finger tip location thereby increasing the number of possible sampling sites from which to extract a sample of body fluid.
  • citric acid (a buffering agent). Adjust the pH of the citric acid solution with NaOH to a value of 4.25.
  • a piece of polyethersulfone membrane is uniformly coated with reagent la; the excess is squeegied off and the material is dried.
  • the membrane is then coated with reagent 2a in the same fashion and dried.
  • the membrane is then assembled into a test device as shown in Figure 1. Whole blood is applied to the capillary opening and the glucose level is read from the front based on the indicator response in the test zone.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • General Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Food Science & Technology (AREA)
  • General Physics & Mathematics (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Cell Biology (AREA)
  • Biochemistry (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Pathology (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Investigating Or Analyzing Non-Biological Materials By The Use Of Chemical Means (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
PCT/US1998/011407 1997-06-17 1998-06-15 Device for determination of an analyte in a body fluid Ceased WO1998058260A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
JP50448299A JP2002510392A (ja) 1997-06-17 1998-06-15 体液内分析物測定装置
AU82530/98A AU8253098A (en) 1997-06-17 1998-06-15 Device for determination of an analyte in a body fluid
DE69836272T DE69836272T2 (de) 1997-06-17 1998-06-15 Versuchsanordnung zur bestimmung von analyten in körperflüssigkeiten
EP98932712A EP0993614B1 (en) 1997-06-17 1998-06-15 Device for determination of an analyte in a body fluid

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/874,468 US5948695A (en) 1997-06-17 1997-06-17 Device for determination of an analyte in a body fluid
US08/874,468 1997-06-17

Publications (1)

Publication Number Publication Date
WO1998058260A1 true WO1998058260A1 (en) 1998-12-23

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PCT/US1998/011407 Ceased WO1998058260A1 (en) 1997-06-17 1998-06-15 Device for determination of an analyte in a body fluid

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US (3) US5948695A (enExample)
EP (1) EP0993614B1 (enExample)
JP (1) JP2002510392A (enExample)
AU (1) AU8253098A (enExample)
DE (3) DE69836272T2 (enExample)
GB (1) GB2323666B (enExample)
WO (1) WO1998058260A1 (enExample)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7670300B2 (en) 2003-07-28 2010-03-02 Bayer Healthcare Llc Swing lance with integrated sensor
US9480981B2 (en) 2014-07-25 2016-11-01 General Electric Company Sample collection and transfer device
US9901922B2 (en) 2014-07-25 2018-02-27 General Electric Company Sample collection and transfer device

Families Citing this family (158)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020010406A1 (en) 1996-05-17 2002-01-24 Douglas Joel S. Methods and apparatus for expressing body fluid from an incision
US7828749B2 (en) 1996-05-17 2010-11-09 Roche Diagnostics Operations, Inc. Blood and interstitial fluid sampling device
US7235056B2 (en) 1996-05-17 2007-06-26 Amira Medical Body fluid sampling device and methods of use
EP1579814A3 (en) 1996-05-17 2006-06-14 Roche Diagnostics Operations, Inc. Methods and apparatus for sampling and analyzing body fluid
US5948695A (en) * 1997-06-17 1999-09-07 Mercury Diagnostics, Inc. Device for determination of an analyte in a body fluid
AU2005399A (en) * 1997-12-19 1999-07-12 Amira Medical Embossed test strip system
US6656697B1 (en) * 1998-09-28 2003-12-02 Lifescan, Inc. Diagnostics based on tetrazolium compounds
US6036659A (en) 1998-10-09 2000-03-14 Flexsite Diagnostics, Inc. Collection device for biological samples and methods of use
FR2792333B1 (fr) * 1999-04-14 2003-01-24 Labonord Dispositif de depot de cellules sur une plaque d'analyse
ATE418387T1 (de) * 1999-10-22 2009-01-15 Ngk Insulators Ltd Flüssigkeitsspender und verfahren zur herstellung von dna chip
US6696240B1 (en) * 1999-10-26 2004-02-24 Micronix, Inc. Capillary test strip to separate particulates
GB2357143A (en) * 1999-12-10 2001-06-13 Surescreen Diagnostics Ltd Analytical test device
US6627057B1 (en) 1999-12-23 2003-09-30 Roche Diagnostic Corporation Microsphere containing sensor
BR0114778A (pt) * 2000-10-18 2005-02-09 Clarity Technologies Inc Processo e dispositivo para diluir um fluido e detectar analitos em um fluido diluìdo
US6540890B1 (en) * 2000-11-01 2003-04-01 Roche Diagnostics Corporation Biosensor
US6583722B2 (en) 2000-12-12 2003-06-24 Kimberly-Clark Worldwide, Inc. Wetness signaling device
US6603403B2 (en) 2000-12-12 2003-08-05 Kimberly-Clark Worldwide, Inc. Remote, wetness signaling system
US6833111B2 (en) * 2001-04-13 2004-12-21 Varian, Inc. Multiple analyte assaying device with a multiple sample introduction system
US6565808B2 (en) 2001-05-18 2003-05-20 Acon Laboratories Line test device and methods of use
US6890484B2 (en) 2001-05-18 2005-05-10 Acon Laboratories, Inc. In line test device and methods of use
EP2290358B1 (en) * 2001-07-27 2015-11-11 ARKRAY, Inc. Analyzing instrument
KR100550707B1 (ko) * 2001-08-09 2006-02-08 마츠시타 덴끼 산교 가부시키가이샤 바이오센서 및 측정방법
US20040229347A1 (en) * 2001-09-17 2004-11-18 Perez Edward P. Embossed test strip system
WO2003026721A2 (en) * 2001-09-24 2003-04-03 Fukunaga Atsuo F Breathing circuits having unconventional respiratory conduits and systems and methods for optimising utilisation of fresh gases
CA2461370A1 (en) 2001-09-26 2003-05-15 F. Hoffmann-La Roche Ag Method and apparatus for sampling bodily fluid
USD467665S1 (en) 2001-09-28 2002-12-24 Orasure Technologies, Inc. Test device
USD631553S1 (en) 2001-09-28 2011-01-25 Orasure Technologies, Inc. Test device
US6989891B2 (en) 2001-11-08 2006-01-24 Optiscan Biomedical Corporation Device and method for in vitro determination of analyte concentrations within body fluids
US7244393B2 (en) * 2001-12-21 2007-07-17 Kimberly-Clark Worldwide, Inc. Diagnostic device and system
US7004928B2 (en) 2002-02-08 2006-02-28 Rosedale Medical, Inc. Autonomous, ambulatory analyte monitor or drug delivery device
EP1492448A4 (en) * 2002-04-05 2008-03-19 Eyelab Group Llc MONITORING OF BLOOD SUBSTANCES USING SELF-COLLECTED TISSUES
US6759190B2 (en) * 2002-06-15 2004-07-06 Acon Laboratories, Inc. Test strip for detection of analyte and methods of use
US7501053B2 (en) * 2002-10-23 2009-03-10 Abbott Laboratories Biosensor having improved hematocrit and oxygen biases
DE10251669B3 (de) * 2002-11-06 2004-06-17 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Kapillarsubstrat zur Tieftemperaturspeicherung von Suspensionsproben
US7560272B2 (en) 2003-01-04 2009-07-14 Inverness Medical Switzerland Gmbh Specimen collection and assay container
US6983177B2 (en) * 2003-01-06 2006-01-03 Optiscan Biomedical Corporation Layered spectroscopic sample element with microporous membrane
US20040131088A1 (en) * 2003-01-08 2004-07-08 Adtran, Inc. Shared T1/E1 signaling bit processor
EP1447665B1 (en) * 2003-02-11 2016-06-29 Bayer HealthCare LLC Method for reducing effect of hematocrit on measurement of an analyte in whole blood
US6900058B2 (en) * 2003-03-11 2005-05-31 Bionostics, Inc. Control solution for photometric analysis
US7052652B2 (en) * 2003-03-24 2006-05-30 Rosedale Medical, Inc. Analyte concentration detection devices and methods
BRPI0415886A (pt) * 2003-10-29 2007-01-09 Mec Dynamics Corp tiras descartáveis e método de determinação da porcentagem de hbalc na hemoglobina
CA2545125A1 (en) * 2003-11-14 2005-06-02 Oakville Hong Kong Co., Limited Rapid sample collection and analysis device and methods of use
US7510849B2 (en) * 2004-01-29 2009-03-31 Glucolight Corporation OCT based method for diagnosis and therapy
US20070207554A1 (en) * 2004-02-26 2007-09-06 Lin Alex C C Medical System and Method for Determining Parameters
WO2005111580A1 (en) * 2004-05-07 2005-11-24 Optiscan Biomedical Corporation Sample element with fringing-reduction capabilities
JP5065013B2 (ja) * 2004-05-14 2012-10-31 バイエル・ヘルスケア・エルエルシー グルコースアッセイにおいてヘマトクリットの調整を行う方法、およびそのための装置
US7695676B2 (en) * 2004-08-11 2010-04-13 Hans Kloepfer Methods and apparatus for analyzing an analysis fluid
US7254429B2 (en) 2004-08-11 2007-08-07 Glucolight Corporation Method and apparatus for monitoring glucose levels in a biological tissue
US8036727B2 (en) 2004-08-11 2011-10-11 Glt Acquisition Corp. Methods for noninvasively measuring analyte levels in a subject
WO2006034102A2 (en) * 2004-09-20 2006-03-30 Bayer Healthcare Llc Biological test strip
US7442557B1 (en) 2004-10-22 2008-10-28 Idexx Laboratories, Inc. Bi-directional flow assay device with reagent bridge
US8475735B2 (en) * 2004-11-01 2013-07-02 Uma Mahesh Babu Disposable immunodiagnostic test system
US7387890B2 (en) * 2004-12-16 2008-06-17 Chembio Diagnostic Systems, Inc. Immunoassay devices and use thereof
US7432111B2 (en) * 2005-02-02 2008-10-07 Standard Diagnostics, Inc. Non-continuous immunoassay device and immunoassay method using the same
US20060195058A1 (en) 2005-02-14 2006-08-31 Gable Jennifer H Methods and apparatus for extracting and analyzing a bodily fluid
US7189522B2 (en) 2005-03-11 2007-03-13 Chembio Diagnostic Systems, Inc. Dual path immunoassay device
WO2006098804A2 (en) 2005-03-11 2006-09-21 Chembio Diagnostic Systems, Inc. Dual path immunoassay device
WO2006110859A2 (en) 2005-04-13 2006-10-19 Glucolight Corporation Method for data reduction and calibration of an oct-based blood glucose monitor
US20060281187A1 (en) 2005-06-13 2006-12-14 Rosedale Medical, Inc. Analyte detection devices and methods with hematocrit/volume correction and feedback control
US7887494B2 (en) * 2005-09-30 2011-02-15 Intuity Medical, Inc. Fluid sample transport devices and methods
US8801631B2 (en) 2005-09-30 2014-08-12 Intuity Medical, Inc. Devices and methods for facilitating fluid transport
EP1928316B1 (en) 2005-09-30 2014-02-26 Intuity Medical, Inc. Multi-site body fluid sampling and analysis cartridge
US9561001B2 (en) 2005-10-06 2017-02-07 Optiscan Biomedical Corporation Fluid handling cassette system for body fluid analyzer
US8133741B2 (en) 2005-10-26 2012-03-13 General Electric Company Methods and systems for delivery of fluidic samples to sensor arrays
US7723120B2 (en) * 2005-10-26 2010-05-25 General Electric Company Optical sensor array system and method for parallel processing of chemical and biochemical information
WO2007062575A1 (en) * 2005-11-30 2007-06-07 Inverness Medical Switzerland Gmbh A device for detecting the presence or amount of an analyte in a fluid sample and method thereof
JP4681052B2 (ja) * 2006-06-26 2011-05-11 日本電信電話株式会社 フローセルおよびその製造方法
WO2008014709A1 (en) * 2006-07-26 2008-02-07 Abon Biopharm (Hangzhou) Co., Ltd. Analysis device for biologicla sample
US8797644B2 (en) * 2006-08-11 2014-08-05 The Regents Of The University Of California Capillary-based cell and tissue acquisition system (CTAS)
WO2008049011A2 (en) * 2006-10-18 2008-04-24 Research Development Foundation Alpha-msh therapies for treatment of autoimmune disease
ES2453379T3 (es) * 2007-04-25 2014-04-07 3M Innovative Properties Company Reactivos soportados, métodos y dispositivos
WO2008134466A1 (en) * 2007-04-25 2008-11-06 3M Innovative Properties Company Chemical component and processing device assembly
US7883898B2 (en) * 2007-05-07 2011-02-08 General Electric Company Method and apparatus for measuring pH of low alkalinity solutions
US8417311B2 (en) 2008-09-12 2013-04-09 Optiscan Biomedical Corporation Fluid component analysis system and method for glucose monitoring and control
KR101067803B1 (ko) * 2007-07-20 2011-09-27 아크레이 가부시키가이샤 검체 공급 툴 및 이를 이용한 검체 분석용 툴
EP3868284A1 (en) 2007-10-10 2021-08-25 Optiscan Biomedical Corporation Fluid component analysis system and method for glucose monitoring and control
US20100209927A1 (en) * 2007-11-06 2010-08-19 Menon Vinod P Processing device tablet
US8571617B2 (en) 2008-03-04 2013-10-29 Glt Acquisition Corp. Flowometry in optical coherence tomography for analyte level estimation
EP2293719B1 (en) 2008-05-30 2015-09-09 Intuity Medical, Inc. Body fluid sampling device -- sampling site interface
CA3095014A1 (en) 2008-06-06 2009-12-10 Intuity Medical, Inc. Detection meter and mode of operation
EP2299904B1 (en) 2008-06-06 2019-09-11 Intuity Medical, Inc. Medical measurement method
US20100022916A1 (en) 2008-07-24 2010-01-28 Javanbakhsh Esfandiari Method and Apparatus for Collecting and Preparing Biological Samples for Testing
US7959598B2 (en) 2008-08-20 2011-06-14 Asante Solutions, Inc. Infusion pump systems and methods
CN102422164B (zh) * 2009-05-15 2015-12-16 柯尼卡美能达株式会社 微芯片
EP2456355B1 (en) 2009-07-20 2016-09-14 Optiscan Biomedical Corporation Adjustable connector and dead space reduction
US9554742B2 (en) 2009-07-20 2017-01-31 Optiscan Biomedical Corporation Fluid analysis system
US8012770B2 (en) 2009-07-31 2011-09-06 Invisible Sentinel, Inc. Device for detection of antigens and uses thereof
WO2011044574A1 (en) 2009-10-09 2011-04-14 Invisible Sentinel Device for detection of antigens and uses thereof
EP2496941B1 (en) 2009-11-04 2016-07-13 Thomas M. Buchanan Methods and devices to enhance sensitivity and evaluate sample adequacy and reagent reactivity in rapid lateral flow immunoassays
US8919605B2 (en) 2009-11-30 2014-12-30 Intuity Medical, Inc. Calibration material delivery devices and methods
CN105044320B (zh) 2010-03-25 2017-02-22 艾博生物医药(杭州)有限公司 测试液体样本中被分析物的检测装置
WO2011156522A1 (en) 2010-06-09 2011-12-15 Optiscan Biomedical Corporation Measuring analytes in a fluid sample drawn from a patient
CA2803797A1 (en) 2010-06-25 2011-12-29 Intuity Medical, Inc. Analyte monitoring methods and systems
AU2012211141B2 (en) 2011-01-27 2016-11-03 Invisible Sentinel, Inc. Analyte detection devices, multiplex and tabletop devices for detection of analytes, and uses thereof
US8603835B2 (en) 2011-02-10 2013-12-10 Chembio Diagnostic Systems, Inc. Reduced step dual path immunoassay device and method
WO2013006716A1 (en) 2011-07-06 2013-01-10 Optiscan Biomedical Corporation Sample cell for fluid analysis system
CA2843945C (en) 2011-08-03 2022-06-21 Intuity Medical, Inc. Devices and methods for body fluid sampling and analysis
JP2015508493A (ja) * 2011-12-22 2015-03-19 ディーエスエム アイピー アセッツ ビー．ブイ． 多層織物製品および乾燥マトリックススポット用途用担体としての多層織物製品の使用
US9451914B2 (en) * 2012-01-03 2016-09-27 Charleston Area Medical Center, Inc. Integrated needle and test strip assembly and method of use
CN104160277B (zh) * 2012-01-11 2017-05-17 嘉泉大学校产学协力团 用于测量血糖水平的单元、包含该单元的系统以及用于测量血糖水平的方法
AU2013230917C1 (en) 2012-03-09 2021-09-16 Invisible Sentinel, Inc. Methods and compositions for detecting multiple analytes with a single signal
USD713973S1 (en) * 2012-09-25 2014-09-23 PDx BioTech Diagnostic test device
CN105283757B (zh) 2013-03-15 2019-04-23 豪夫迈·罗氏有限公司 对分析物的电化学测量进行防故障的方法以及结合该方法的设备、装置和系统
CA2900572C (en) 2013-03-15 2018-02-13 F. Hoffmann-La Roche Ag Methods of detecting high antioxidant levels during electrochemical measurements and failsafing an analyte concentration therefrom as well as devices, apparatuses and systems incorporting the same
WO2014140164A1 (en) 2013-03-15 2014-09-18 Roche Diagnostics Gmbh Methods of using information from recovery pulses in electrochemical analyte measurements as well as devices, apparatuses and systems incorporating the same
EP3385706A1 (en) 2013-03-15 2018-10-10 Roche Diabetes Care GmbH Methods of scaling data used to construct biosensor algorithms as well as devices, apparatuses and systems incorporating the same
EP3011544A4 (en) 2013-06-21 2017-02-22 Intuity Medical, Inc. Analyte monitoring system with audible feedback
WO2015005504A1 (ko) * 2013-07-08 2015-01-15 가천대학교 산학협력단 혈당측정용 바이오칩 및 그를 포함하는 스마트폰용 혈당측정기
US9561324B2 (en) 2013-07-19 2017-02-07 Bigfoot Biomedical, Inc. Infusion pump system and method
GB2523989B (en) 2014-01-30 2020-07-29 Insulet Netherlands B V Therapeutic product delivery system and method of pairing
BR112016022829B1 (pt) 2014-04-02 2022-03-03 Chembio Diagnostic Systems, Inc Dispositivo de teste para determinar a presença de um primeiro ligante em uma amostra líquida, e método para testar uma amostra quanto à presença de um primeiro ligante
JP6359348B2 (ja) * 2014-06-06 2018-07-18 キヤノンメディカルシステムズ株式会社 センサチップ及びセンサチップへの液体供給方法
WO2016054030A1 (en) * 2014-09-30 2016-04-07 Siemens Healthcare Diagnostics Inc. Hemolysis detection device, system and method
US20160116466A1 (en) 2014-10-27 2016-04-28 Chembio Diagnostic Systems, Inc. Rapid Screening Assay for Qualitative Detection of Multiple Febrile Illnesses
CN111905188B (zh) 2015-02-18 2022-07-22 英赛罗公司 流体输送和输注装置及其使用方法
WO2017123525A1 (en) 2016-01-13 2017-07-20 Bigfoot Biomedical, Inc. User interface for diabetes management system
EP3402548B1 (en) 2016-01-14 2025-03-12 Insulet Corporation Occlusion resolution in medication delivery devices, systems, and methods
JP6876046B2 (ja) 2016-01-14 2021-05-26 ビッグフット バイオメディカル インコーポレイテッドＢｉｇｆｏｏｔ Ｂｉｏｍｅｄｉｃａｌ， Ｉｎｃ． インスリン・デリバリ量の調節
US12383166B2 (en) 2016-05-23 2025-08-12 Insulet Corporation Insulin delivery system and methods with risk-based set points
US10765807B2 (en) 2016-09-23 2020-09-08 Insulet Corporation Fluid delivery device with sensor
PL3523639T3 (pl) 2016-10-05 2025-03-17 F. Hoffmann-La Roche Ag Odczynniki wykrywające i układy elektrod do elementów diagnostycznych testów wieloanalitowych oraz sposoby ich zastosowania
CA3041623A1 (en) 2016-10-24 2018-05-03 F. Hoffmann-La Roche Ag Methods of correcting for uncompensated resistances in the conductive elements of biosensors, as well as devices and systems
CA3037432A1 (en) 2016-12-12 2018-06-21 Bigfoot Biomedical, Inc. Alarms and alerts for medication delivery devices and related systems and methods
US10500334B2 (en) 2017-01-13 2019-12-10 Bigfoot Biomedical, Inc. System and method for adjusting insulin delivery
US10758675B2 (en) 2017-01-13 2020-09-01 Bigfoot Biomedical, Inc. System and method for adjusting insulin delivery
EP3568860B1 (en) 2017-01-13 2025-12-10 Insulet Corporation Insulin delivery methods, systems and devices
WO2018132754A1 (en) 2017-01-13 2018-07-19 Mazlish Bryan System and method for adjusting insulin delivery
EP3568859B1 (en) 2017-01-13 2025-12-10 Insulet Corporation Insulin delivery methods, systems and devices
USD928199S1 (en) 2018-04-02 2021-08-17 Bigfoot Biomedical, Inc. Medication delivery device with icons
US11565043B2 (en) 2018-05-04 2023-01-31 Insulet Corporation Safety constraints for a control algorithm based drug delivery system
CN112789070A (zh) 2018-09-28 2021-05-11 英赛罗公司 人造胰腺系统的活动模式
US11565039B2 (en) 2018-10-11 2023-01-31 Insulet Corporation Event detection for drug delivery system
USD920343S1 (en) 2019-01-09 2021-05-25 Bigfoot Biomedical, Inc. Display screen or portion thereof with graphical user interface associated with insulin delivery
KR102079783B1 (ko) * 2019-07-03 2020-02-21 주식회사 원드롭 생체 물질을 측정하기 위한 스트립
US11801344B2 (en) 2019-09-13 2023-10-31 Insulet Corporation Blood glucose rate of change modulation of meal and correction insulin bolus quantity
US11935637B2 (en) 2019-09-27 2024-03-19 Insulet Corporation Onboarding and total daily insulin adaptivity
KR102168919B1 (ko) 2019-10-25 2020-10-22 주식회사 원드롭 정량 채취가 가능한 시료 수집 장치
EP4354455B1 (en) 2019-12-06 2025-10-29 Insulet Corporation Techniques and devices providing adaptivity and personalization in diabetes treatment
US11833329B2 (en) 2019-12-20 2023-12-05 Insulet Corporation Techniques for improved automatic drug delivery performance using delivery tendencies from past delivery history and use patterns
EP4088286A1 (en) 2020-01-06 2022-11-16 Insulet Corporation Prediction of meal and/or exercise events based on persistent residuals
EP4100958A1 (en) 2020-02-03 2022-12-14 Insulet Corporation Use of fuzzy logic in predicting user behavior affecting blood glucose concentration
US11551802B2 (en) 2020-02-11 2023-01-10 Insulet Corporation Early meal detection and calorie intake detection
US11547800B2 (en) 2020-02-12 2023-01-10 Insulet Corporation User parameter dependent cost function for personalized reduction of hypoglycemia and/or hyperglycemia in a closed loop artificial pancreas system
US11986630B2 (en) 2020-02-12 2024-05-21 Insulet Corporation Dual hormone delivery system for reducing impending hypoglycemia and/or hyperglycemia risk
US11324889B2 (en) 2020-02-14 2022-05-10 Insulet Corporation Compensation for missing readings from a glucose monitor in an automated insulin delivery system
US11607493B2 (en) 2020-04-06 2023-03-21 Insulet Corporation Initial total daily insulin setting for user onboarding
WO2022020197A1 (en) 2020-07-22 2022-01-27 Insulet Corporation Open-loop insulin delivery basal parameters based on insulin delivery records
US11684716B2 (en) 2020-07-31 2023-06-27 Insulet Corporation Techniques to reduce risk of occlusions in drug delivery systems
GB202013085D0 (en) * 2020-08-21 2020-10-07 Vidya Holdings Ltd Improvements in or relating to a device for analysing a sample
US12128215B2 (en) 2020-09-30 2024-10-29 Insulet Corporation Drug delivery device with integrated optical-based glucose monitor
WO2022072618A1 (en) 2020-09-30 2022-04-07 Insulet Corporation Secure wireless communications between a glucose monitor and other devices
US11160925B1 (en) 2021-01-29 2021-11-02 Insulet Corporation Automatic drug delivery system for delivery of a GLP-1 therapeutic
US11904140B2 (en) 2021-03-10 2024-02-20 Insulet Corporation Adaptable asymmetric medicament cost component in a control system for medicament delivery
US12431229B2 (en) 2021-03-10 2025-09-30 Insulet Corporation Medicament delivery device with an adjustable and piecewise analyte level cost component to address persistent positive analyte level excursions
US12406760B2 (en) 2021-06-07 2025-09-02 Insulet Corporation Exercise safety prediction based on physiological conditions
WO2023049900A1 (en) 2021-09-27 2023-03-30 Insulet Corporation Techniques enabling adaptation of parameters in aid systems by user input
US11439754B1 (en) 2021-12-01 2022-09-13 Insulet Corporation Optimizing embedded formulations for drug delivery
CA3275991A1 (en) 2023-01-06 2024-07-11 Insulet Corp Automatic or manual administration of meal boluses with subsequent automatic relaxation of safety constraints

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4839296A (en) * 1985-10-18 1989-06-13 Chem-Elec, Inc. Blood plasma test method

Family Cites Families (132)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3092465A (en) * 1960-03-25 1963-06-04 Miles Lab Diagnostic test device for blood sugar
US3298789A (en) * 1964-12-14 1967-01-17 Miles Lab Test article for the detection of glucose
DE1598153C3 (de) * 1966-11-22 1973-11-22 Boehringer Mannheim Gmbh, 6800 Mannheim Diagnostisches Mittel zum Nach weis der Inhaltsstoffe von Korperflus sigkeiten
US3552928A (en) * 1967-07-19 1971-01-05 Miles Lab Whole blood separation means and test system using same
US3607093A (en) * 1968-02-15 1971-09-21 Schering Corp Devices for testing biological liquids
US3992158A (en) * 1973-08-16 1976-11-16 Eastman Kodak Company Integral analytical element
US4042335A (en) * 1975-07-23 1977-08-16 Eastman Kodak Company Integral element for analysis of liquids
DE2611721B2 (de) * 1976-03-19 1978-10-26 R. Geerd Dr.Med. 6108 Weiterstadt Hamer Vakuum-Sauggerät zum Absaugen von Gewebeserum
CA1095819A (en) * 1977-01-14 1981-02-17 Eastman Kodak Company Element for analysis of liquids
DD137384B1 (de) * 1977-11-04 1981-07-29 Kallies Karl Heinz Indikator-kapillar-roehrchen zur harnstoff-bestimmung
USD254444S (en) * 1977-09-01 1980-03-11 Levine Robert A Blood sampling needle
US4258001A (en) * 1978-12-27 1981-03-24 Eastman Kodak Company Element, structure and method for the analysis or transport of liquids
US4360016A (en) * 1980-07-01 1982-11-23 Transidyne General Corp. Blood collecting device
DE3029579C2 (de) * 1980-08-05 1985-12-12 Boehringer Mannheim Gmbh, 6800 Mannheim Verfahren und Mittel zur Abtrennung von Plasma oder Serum aus Vollblut
GB2090659A (en) * 1981-01-02 1982-07-14 Instrumentation Labor Inc Analytical device
US4503856A (en) * 1981-06-29 1985-03-12 Sherwood Medical Company Lancet injector
US5073484A (en) * 1982-03-09 1991-12-17 Bio-Metric Systems, Inc. Quantitative analysis apparatus and method
CA1205731A (en) * 1982-11-01 1986-06-10 Roger C. Phillips Test device and method for measurement of analyte levels in colored aqueous fluids
US4517978A (en) * 1983-01-13 1985-05-21 Levin Paul D Blood sampling instrument
CA1226036A (en) * 1983-05-05 1987-08-25 Irving J. Higgins Analytical equipment and sensor electrodes therefor
US4900666A (en) * 1983-07-12 1990-02-13 Lifescan, Inc. Colorimetric ethanol analysis method and test device
US4734360A (en) * 1983-07-12 1988-03-29 Lifescan, Inc. Colorimetric ethanol analysis method and test device
AU3552284A (en) * 1983-10-17 1985-05-07 Inomedix Inc. Device for rapid quantitative analysis of a fluid
US4637978A (en) * 1983-10-28 1987-01-20 Eastman Kodak Company Assay for analysis of whole blood
DE3407359A1 (de) * 1984-02-29 1985-08-29 Bayer Ag, 5090 Leverkusen Testvorrichtung und methode zum nachweis einer komponente einer fluessigen probe
US4622974A (en) * 1984-03-07 1986-11-18 University Of Tennessee Research Corporation Apparatus and method for in-vivo measurements of chemical concentrations
GB8406154D0 (en) 1984-03-09 1984-04-11 Palmer G C Sampling fluid
NL8401536A (nl) * 1984-05-11 1985-12-02 Medscan B V I O Bloedbemonsteringseenheid.
US4826759A (en) * 1984-10-04 1989-05-02 Bio-Metric Systems, Inc. Field assay for ligands
US4653511A (en) * 1984-10-05 1987-03-31 Goch Thomas A Microsample blood collecting device
US5279294A (en) * 1985-04-08 1994-01-18 Cascade Medical, Inc. Medical diagnostic system
US4627445A (en) * 1985-04-08 1986-12-09 Garid, Inc. Glucose medical monitoring system
US4787398A (en) * 1985-04-08 1988-11-29 Garid, Inc. Glucose medical monitoring system
US4678757A (en) * 1985-04-11 1987-07-07 Smithkline Diagnostics, Inc. Device and method for whole blood separation and analysis
US4653513A (en) * 1985-08-09 1987-03-31 Dombrowski Mitchell P Blood sampler
US4658821A (en) * 1986-01-08 1987-04-21 Packaging Corporation International A/K/A/ Medicore Ejector for an automatic lancet arm
DE3708031A1 (de) 1986-03-20 1987-11-12 Wolfgang Dr Med Wagner Messeinrichtung oder induktionseinrichtung mit messeinrichtung oder vorrichtung zur materialgewinnung fuer eine messvorrichtung fuer stoffwechselzustaende im blut mittels punktion unter anwendung von unterdruck innerhalb einer saugglocke bei verlagerung der messzone ausserhalb des spitzenbereiches des punktionsgeraetes
US4906439A (en) * 1986-03-25 1990-03-06 Pb Diagnostic Systems, Inc. Biological diagnostic device and method of use
US4685463A (en) * 1986-04-03 1987-08-11 Williams R Bruce Device for continuous in vivo measurement of blood glucose concentrations
US4994167A (en) * 1986-04-15 1991-02-19 Markwell Medical Institute, Inc. Biological fluid measuring device
US5029583A (en) * 1986-07-22 1991-07-09 Personal Diagnostics, Inc. Optical analyzer
US4873993A (en) * 1986-07-22 1989-10-17 Personal Diagnostics, Inc. Cuvette
US5049487A (en) * 1986-08-13 1991-09-17 Lifescan, Inc. Automated initiation of timing of reflectance readings
US4935346A (en) * 1986-08-13 1990-06-19 Lifescan, Inc. Minimum procedure system for the determination of analytes
US4790979A (en) * 1986-08-29 1988-12-13 Technimed Corporation Test strip and fixture
US5178831A (en) * 1986-10-08 1993-01-12 Dai Nippon Insatsu Kab Ushiki Kaisha Device for testing body fluids
US4774192A (en) * 1987-01-28 1988-09-27 Technimed Corporation A dry reagent delivery system with membrane having porosity gradient
US5002054A (en) * 1987-02-25 1991-03-26 Ash Medical Systems, Inc. Interstitial filtration and collection device and method for long-term monitoring of physiological constituents of the body
US4999287A (en) * 1988-05-19 1991-03-12 Chemtrak Corporation Direct measuring assay strip and method of use thereof
US4805623A (en) * 1987-09-04 1989-02-21 Vander Corporation Spectrophotometric method for quantitatively determining the concentration of a dilute component in a light- or other radiation-scattering environment
US4850973A (en) * 1987-10-16 1989-07-25 Pavel Jordon & Associates Plastic device for injection and obtaining blood samples
US4818677A (en) * 1987-12-03 1989-04-04 Monoclonal Antibodies, Inc. Membrane assay using focused sample application
US5014718A (en) * 1988-01-22 1991-05-14 Safety Diagnostics, Inc. Blood collection and testing method
US5070886A (en) * 1988-01-22 1991-12-10 Safety Diagnostice, Inc. Blood collection and testing means
US4883068A (en) * 1988-03-14 1989-11-28 Dec In Tech, Inc. Blood sampling device and method
US5164294A (en) * 1988-05-17 1992-11-17 Syntex (U.S.A.) Inc. Method for immunochromatographic analysis
US4994238A (en) * 1988-06-09 1991-02-19 Daffern George M Constant volume chemical analysis test device
US4924879A (en) * 1988-10-07 1990-05-15 Brien Walter J O Blood lancet device
US4995402A (en) * 1988-10-12 1991-02-26 Thorne, Smith, Astill Technologies, Inc. Medical droplet whole blood and like monitoring
US4920977A (en) * 1988-10-25 1990-05-01 Becton, Dickinson And Company Blood collection assembly with lancet and microcollection tube
US5202268A (en) * 1988-12-30 1993-04-13 Environmental Diagnostics, Inc. Multi-layered test card for the determination of substances in liquids
US5035704A (en) * 1989-03-07 1991-07-30 Lambert Robert D Blood sampling mechanism
US5054499A (en) * 1989-03-27 1991-10-08 Swierczek Remi D Disposable skin perforator and blood testing device
US4953552A (en) * 1989-04-21 1990-09-04 Demarzo Arthur P Blood glucose monitoring system
US5100620A (en) * 1989-05-15 1992-03-31 Miles, Inc. Capillary tube/gap reagent format
ATE117804T1 (de) * 1989-06-05 1995-02-15 Janssen Pharmaceutica Nv Festphasen-test zur verwendung mit einem physikalischen entwickler.
US4976724A (en) * 1989-08-25 1990-12-11 Lifescan, Inc. Lancet ejector mechanism
US5306623A (en) * 1989-08-28 1994-04-26 Lifescan, Inc. Visual blood glucose concentration test strip
AU640162B2 (en) * 1989-08-28 1993-08-19 Lifescan, Inc. Blood separation and analyte detection techniques
US5620863A (en) * 1989-08-28 1997-04-15 Lifescan, Inc. Blood glucose strip having reduced side reactions
US4994068A (en) * 1989-11-24 1991-02-19 Unidex, Inc. Combination sterile pad support and lancet containing lancet disposal element
US5252496A (en) * 1989-12-18 1993-10-12 Princeton Biomeditech Corporation Carbon black immunochemical label
US5223220A (en) * 1990-03-27 1993-06-29 Pacific Biotech, Inc. Solid phase immunoassay device and method of making same
US5161532A (en) * 1990-04-19 1992-11-10 Teknekron Sensor Development Corporation Integral interstitial fluid sensor
DE4015590A1 (de) * 1990-05-15 1991-11-21 Boehringer Mannheim Gmbh Testtraeger zur bestimmung von ionen
US5066859A (en) * 1990-05-18 1991-11-19 Karkar Maurice N Hematocrit and oxygen saturation blood analyzer
US5096833A (en) * 1990-05-29 1992-03-17 Miles Inc. Method and device for determining protein using carrier matrix composed of urethane, water insouble inorganic compound and insoluble organic compound and method of making the device
US5187100A (en) * 1990-05-29 1993-02-16 Lifescan, Inc. Dispersion to limit penetration of aqueous solutions into a membrane
US5208163A (en) * 1990-08-06 1993-05-04 Miles Inc. Self-metering fluid analysis device
US5147606A (en) * 1990-08-06 1992-09-15 Miles Inc. Self-metering fluid analysis device
US5565170A (en) * 1990-08-30 1996-10-15 Kyoto Daiichi Kagaku Co., Ltd. Multilayer analytical element for assaying fructosamine
JPH06500174A (ja) * 1990-10-30 1994-01-06 ハイポガード（ユーケイ）リミテッド 収集及び表示装置
DE4117847A1 (de) * 1991-05-31 1992-12-03 Lre Relais & Elektronik Gmbh Verfahren zum auswerten binaerer informationen
US5402798A (en) * 1991-07-18 1995-04-04 Swierczek; Remi Disposable skin perforator and blood testing device
US5163442A (en) * 1991-07-30 1992-11-17 Harry Ono Finger tip blood collector
FR2688311B1 (fr) * 1991-11-12 1995-03-10 Boy Inst Jacques Procede pour la mise en evidence d'agglutinats erythrocytaires.
US5231993A (en) * 1991-11-20 1993-08-03 Habley Medical Technology Corporation Blood sampler and component tester with guide member
US5334502A (en) * 1991-11-27 1994-08-02 Osborn Laboratories, Inc. Method of collecting, identifying, and quantifying saliva
DE4202850A1 (de) * 1992-01-31 1993-08-05 Boehringer Mannheim Gmbh Analysenelement fuer immunoassays
JP2572823Y2 (ja) * 1992-02-13 1998-05-25 株式会社アドバンス 簡易採血器
US5165418B1 (en) * 1992-03-02 1999-12-14 Nikola I Tankovich Blood sampling device and method using a laser
DE4212315A1 (de) * 1992-04-13 1993-10-14 Boehringer Mannheim Gmbh Blutlanzettenvorrichtung zur Entnahme von Blut für Diagnosezwecke
US5318583A (en) * 1992-05-05 1994-06-07 Ryder International Corporation Lancet actuator mechanism
DE4217733A1 (de) * 1992-05-29 1993-12-02 Boehringer Mannheim Gmbh Testträger zur Analytbestimmung sowie Verfahren zu dessen Herstellung
US5217480A (en) * 1992-06-09 1993-06-08 Habley Medical Technology Corporation Capillary blood drawing device
US5277198A (en) * 1992-07-27 1994-01-11 Ryder International Corporation Blood sampling syringe
US5354692A (en) * 1992-09-08 1994-10-11 Pacific Biotech, Inc. Analyte detection device including a hydrophobic barrier for improved fluid flow
US5569212A (en) * 1994-07-22 1996-10-29 Raya Systems, Inc. Apparatus for electrically determining injection doses in syringes
US5395387A (en) * 1993-02-26 1995-03-07 Becton Dickinson And Company Lancet blade designed for reduced pain
JP2630197B2 (ja) * 1993-04-28 1997-07-16 株式会社ニッショー 血液吸出器具
US5843691A (en) 1993-05-15 1998-12-01 Lifescan, Inc. Visually-readable reagent test strip
CA2127172C (en) * 1993-08-05 1998-07-14 Amy H. Chu Analyte detection device and process
AU7563294A (en) * 1993-08-24 1995-03-21 Metrika Laboratories, Inc. Novel disposable electronic assay device
US5522255A (en) * 1993-08-31 1996-06-04 Boehringer Mannheim Corporation Fluid dose, flow and coagulation sensor for medical instrument
US5582184A (en) * 1993-10-13 1996-12-10 Integ Incorporated Interstitial fluid collection and constituent measurement
CA2175056A1 (en) * 1993-10-28 1995-05-04 Imants R. Lauks Fluid sample collection and introduction device
US5456835A (en) * 1993-11-08 1995-10-10 Hemasure, Inc. Device and process for removing free hemoglobin from blood
US5725831A (en) * 1994-03-14 1998-03-10 Becton Dickinson And Company Nucleic acid amplification apparatus
US5556761A (en) * 1994-04-26 1996-09-17 Phillips; Kevin J. Test strip for blood glucose testing
DE4415896A1 (de) * 1994-05-05 1995-11-09 Boehringer Mannheim Gmbh Analysesystem zur Überwachung der Konzentration eines Analyten im Blut eines Patienten
US5700695A (en) * 1994-06-30 1997-12-23 Zia Yassinzadeh Sample collection and manipulation method
US5547702A (en) * 1994-07-08 1996-08-20 Polymer Technology International Corporation Method for continuous manufacture of diagnostic test strips
US5518006A (en) * 1994-08-09 1996-05-21 International Technidyne Corp. Blood sampling device
US5515170A (en) * 1994-09-08 1996-05-07 Lifescan, Inc. Analyte detection device having a serpentine passageway for indicator strips
US5563031A (en) * 1994-09-08 1996-10-08 Lifescan, Inc. Highly stable oxidative coupling dye for spectrophotometric determination of analytes
US5526120A (en) * 1994-09-08 1996-06-11 Lifescan, Inc. Test strip with an asymmetrical end insuring correct insertion for measuring
US5597532A (en) * 1994-10-20 1997-01-28 Connolly; James Apparatus for determining substances contained in a body fluid
US5668017A (en) * 1995-02-10 1997-09-16 Path Radial absorption device
US5628764A (en) * 1995-03-21 1997-05-13 Schraga; Steven Collar lancet device
AU706456B2 (en) * 1995-03-27 1999-06-17 Lifescan, Inc. Chemical timer for a direct-reading reagent test strip
US5712172A (en) * 1995-05-18 1998-01-27 Wyntek Diagnostics, Inc. One step immunochromatographic device and method of use
NZ299104A (en) * 1995-08-03 1998-04-27 Lifescan Inc Reagent test strip
US5682233A (en) * 1995-09-08 1997-10-28 Integ, Inc. Interstitial fluid sampler
AU722471B2 (en) * 1995-10-17 2000-08-03 Lifescan, Inc. Blood glucose strip having reduced sensitivity to hematocrit
US5628309A (en) 1996-01-25 1997-05-13 Raya Systems, Inc. Meter for electrically measuring and recording injection syringe doses
IL120587A (en) * 1996-04-04 2000-10-31 Lifescan Inc Reagent test strip for determination of blood glucose
US5962215A (en) * 1996-04-05 1999-10-05 Mercury Diagnostics, Inc. Methods for testing the concentration of an analyte in a body fluid
WO1997042888A1 (en) * 1996-05-17 1997-11-20 Mercury Diagnostics Inc. Blood and interstitial fluid sampling device
WO1997043962A1 (en) 1996-05-17 1997-11-27 Mercury Diagnostics, Inc. Methods and apparatus for expressing body fluid from an incision
WO1998019159A1 (en) * 1996-10-30 1998-05-07 Mercury Diagnostics, Inc. Synchronized analyte testing system
US5948695A (en) * 1997-06-17 1999-09-07 Mercury Diagnostics, Inc. Device for determination of an analyte in a body fluid
AU2005399A (en) * 1997-12-19 1999-07-12 Amira Medical Embossed test strip system

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4839296A (en) * 1985-10-18 1989-06-13 Chem-Elec, Inc. Blood plasma test method

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP0993614A4 *

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7670300B2 (en) 2003-07-28 2010-03-02 Bayer Healthcare Llc Swing lance with integrated sensor
US8251920B2 (en) 2003-07-28 2012-08-28 Bayer Healthcare Llc Swing lance with integrated sensor
US9480981B2 (en) 2014-07-25 2016-11-01 General Electric Company Sample collection and transfer device
US9901922B2 (en) 2014-07-25 2018-02-27 General Electric Company Sample collection and transfer device

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GB2323666B (en) 1999-09-22
JP2002510392A (ja) 2002-04-02
US5948695A (en) 1999-09-07
GB2323666A (en) 1998-09-30
US6780651B2 (en) 2004-08-24
DE29810858U1 (de) 1998-09-24
US20020052050A1 (en) 2002-05-02
EP0993614B1 (en) 2006-10-25
AU8253098A (en) 1999-01-04
DE69836272T2 (de) 2007-02-15
EP0993614A4 (en) 2004-10-13
DE19826957C2 (de) 2001-11-08
DE19826957A1 (de) 1998-12-24
GB9813023D0 (en) 1998-08-12
EP0993614A1 (en) 2000-04-19
DE69836272D1 (de) 2006-12-07
US6271045B1 (en) 2001-08-07

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