CA2423077A1 - Micro-invasive method for painless detection of analytes in extracellular space - Google Patents

Micro-invasive method for painless detection of analytes in extracellular space Download PDF

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Publication number
CA2423077A1
CA2423077A1 CA002423077A CA2423077A CA2423077A1 CA 2423077 A1 CA2423077 A1 CA 2423077A1 CA 002423077 A CA002423077 A CA 002423077A CA 2423077 A CA2423077 A CA 2423077A CA 2423077 A1 CA2423077 A1 CA 2423077A1
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CA
Canada
Prior art keywords
microprobe
analyte
interstitial fluid
set forth
extra
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.)
Granted
Application number
CA002423077A
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French (fr)
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CA2423077C (en
Inventor
Eric Jules Raskas
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Becton Dickinson and Co
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Individual
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Publication of CA2423077A1 publication Critical patent/CA2423077A1/en
Application granted granted Critical
Publication of CA2423077C publication Critical patent/CA2423077C/en
Anticipated expiration legal-status Critical
Expired - Lifetime 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
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84—Systems specially adapted for particular applications
    • G01N21/85—Investigating moving fluids or granular solids
    • G01N21/8507—Probe photometers, i.e. with optical measuring part dipped into fluid sample
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • 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, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14507—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
    • A61B5/1451—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid
    • A61B5/14514—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
    • 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, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, 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
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14546—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • 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, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • 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, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/1459—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6825—Hand
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B2010/008—Interstitial fluid
    • 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
    • A61B2562/12—Manufacturing methods specially adapted for producing sensors for in-vivo measurements
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y80/00—Products made by additive manufacturing

Abstract

A method of detecting at least one analyte in extra-cellular spaces includes the step of inserting a microprobe through the stratum corneum toward the stratum basale of the skin of a subject into extra-cellular spaces containin g interstitial fluid having at least one analyte to be detected, said micropro be having a diameter at its tip no larger than approximately 10-50 microns. The method further includes optically testing for a predetermined analyte in the extra-cellular space adjacent the distal end of the microprobe without drawi ng a sample of the interstitial fluid. Preferably the microprobe body includes a sensor layer covering the distal optical tip of the microprobe body, the sensor layer being adapted to interact with a predetermined analyte to be detected in the interstitial fluid, and an optical detector responsive to interaction of the sensor layer with the predetermined analyte to signal detection of said predetermined analyte.

Claims (11)

1. An optical microprobe system for detecting at least one analyte in extra-cellular spaces comprising:
a microprobe body terminating in a distal optical tip adapted to enter the stratum corneum of the skin of a subject and extend toward the stratum basale of the skin terminating in extra-cellular spaces containing interstitial fluid, the microprobe body being shaped to cause the microprobe tip to stop in the extra cellular spaces of the skin;
a sensor layer covering the distal optical tip of the microprobe body, said sensor layer being adapted to interact with a predetermined analyte to be detected in the interstitial fluid;
an optical detector responsive to interaction of the sensor layer with the predetermined analyte to signal detection of said predetermined analyte.
2. The system as set forth in claim 1 wherein the microprobe body distal optical tip has a diameter no larger than approximately 10-50 microns.
3. The microprobe system as set forth in claim 1 further including a computer for analyzing the signal from the optical detector to determine the concentration of said analyte.
4. The microprobe system as set forth in claim 1 further including an electrically conductive member disposed in and extending to the exterior of the distal tip, said electrically conductive member being connected to a circuit for obtaining electrochemical measurements of an analyte in the interstitial fluid.
5. The microprobe system as set forth in claim 1 further including a plurality of optical distal tips for insertion into but not through the stratum basale of the subject, each optical distal tip its own sensor layer to provide multiple tests of analyte in the interstitial fluid.
6. The microprobe system as set forth in claim 1 wherein the sensor layer is sensitive to an analyte inherently fond in biological systems.
7. The microprobe system as set forth in claim 1 wherein the sensor layer is sensitive to an environmental analyte not commonly found in biological systems.
8. A method of detecting at least one analyte in extra-cellular spaces comprising:
inserting a microprobe through the stratum corneum toward but not through the stratum basale of the skin of a subject into extra-cellular spaces containing interstitial fluid having at least one analyte to be detected, optically testing for a predetermined analyte in the extra-cellular space adjacent the distal end of the microprobe without drawing a sample of the interstitial fluid.
9. The method as set forth in claim 8 wherein said microprobe has a diameter no larger than approximately 10-50 microns.
10. The method as set forth in claim 8 wherein the microprobe is held in place with the distal end thereof in the interstitial fluid for a predetermined time, further including the step of monitoring the concentration of the analyte a plurality of times while the microprobe is held in place.
11. The method as set forth in claim 10 wherein the concentration of the analyte is continuously monitored during the time the microprobe is held in place with the distal end thereof in the interstitial fluid.
CA2423077A 2000-09-22 2001-09-13 Micro-invasive method for painless detection of analytes in extracellular space Expired - Lifetime CA2423077C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/668,703 US6535753B1 (en) 1998-08-20 2000-09-22 Micro-invasive method for painless detection of analytes in extra-cellular space
US09/668,703 2000-09-22
PCT/US2001/028516 WO2002025275A2 (en) 2000-09-22 2001-09-13 Micro-invasive method for painless detection of analytes in extracellular space

Publications (2)

Publication Number Publication Date
CA2423077A1 true CA2423077A1 (en) 2002-03-28
CA2423077C CA2423077C (en) 2011-11-01

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA2423077A Expired - Lifetime CA2423077C (en) 2000-09-22 2001-09-13 Micro-invasive method for painless detection of analytes in extracellular space

Country Status (6)

Country Link
US (4) US6535753B1 (en)
EP (1) EP1319180A2 (en)
JP (1) JP2004526469A (en)
AU (1) AU2001290818A1 (en)
CA (1) CA2423077C (en)
WO (1) WO2002025275A2 (en)

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US20050283057A1 (en) 2005-12-22
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