CA2446637A1 - Portable interstitial fluid monitoring system - Google Patents

Portable interstitial fluid monitoring system Download PDF

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Publication number
CA2446637A1
CA2446637A1 CA002446637A CA2446637A CA2446637A1 CA 2446637 A1 CA2446637 A1 CA 2446637A1 CA 002446637 A CA002446637 A CA 002446637A CA 2446637 A CA2446637 A CA 2446637A CA 2446637 A1 CA2446637 A1 CA 2446637A1
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CA
Canada
Prior art keywords
microneedles
fluid
sampling apparatus
fluid sampling
electrode
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
CA002446637A
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French (fr)
Other versions
CA2446637C (en
Inventor
Faiz Feisal Sherman
Francisco Arias
Vladimir Gartstein
Grover David Owens
Milan Marcel Jevtitch
Chow-Chi Huang
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Corium Inc
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Individual
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Publication of CA2446637A1 publication Critical patent/CA2446637A1/en
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Publication of CA2446637C publication Critical patent/CA2446637C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • 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
    • A61B5/1486—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 enzyme electrodes, e.g. with immobilised oxidase
    • 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
    • A61B5/1455—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
    • A61B5/15—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
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150061—Means for enhancing collection
    • A61B5/150076—Means for enhancing collection by heating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150061—Means for enhancing collection
    • A61B5/150099—Means for enhancing collection by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61B5/150221—Valves
    • A—HUMAN NECESSITIES
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    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150229—Pumps for assisting the blood sampling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
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    • A61B5/150007—Details
    • A61B5/150358—Strips for collecting blood, e.g. absorbent
    • A—HUMAN NECESSITIES
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    • 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
    • A61B5/150389—Hollow piercing elements, e.g. canulas, needles, for piercing the skin
    • A—HUMAN NECESSITIES
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    • A61B5/150503—Single-ended needles
    • A—HUMAN NECESSITIES
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    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150885—Preventing re-use
    • A61B5/150923—Preventing re-use by means for destroying components or parts, e.g. by cutting or piercing
    • A61B5/150938—Preventing re-use by means for destroying components or parts, e.g. by cutting or piercing by blunting or disabling needle
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    • A61B5/15—Devices for taking samples of blood
    • A61B5/150969—Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/15—Devices for taking samples of blood
    • A61B5/150977—Arrays of piercing elements for simultaneous piercing
    • A61B5/150984—Microneedles or microblades
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15103—Piercing procedure
    • A61B5/15105—Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving 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
    • A61B5/151—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
    • A61B5/15125—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 a vacuum or compressed fluids
    • 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
    • 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
    • A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
    • A61B5/15149—Arrangement of piercing elements relative to each other
    • A61B5/15153—Multiple piercing elements stocked in a single compartment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
    • A61B5/15157—Geometry of stocking means or arrangement of piercing elements therein
    • A61B5/15159—Piercing elements stocked in or on a disc
    • A61B5/15163—Characterized by propelling the piercing element in an axial direction relative to the disc
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
    • A61B5/15157—Geometry of stocking means or arrangement of piercing elements therein
    • A61B5/15165—Piercing elements stocked in or on a strip
    • A61B5/15169—Characterized by a rolled strip
    • A—HUMAN NECESSITIES
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    • 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
    • A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
    • A61B5/15157—Geometry of stocking means or arrangement of piercing elements therein
    • A61B5/15165—Piercing elements stocked in or on a strip
    • A61B5/15171—Characterized by propelling the piercing element perpendicular to the direction of movement of the strip
    • A—HUMAN NECESSITIES
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    • A61B5/15—Devices for taking samples of blood
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    • A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
    • A61B5/15178—Stocking means comprising separate compartments or units for new and for used piercing elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61B5/155—Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
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    • 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, 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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A61M2230/201—Glucose concentration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles

Abstract

A strip-like microneedle device is provided that includes an array of hollow microneedles, a diaphragm pump to extract interstitial fluid from skin, and a sensor that detects the concentration of the fluid. The microneedle device c an be interfaced to an external sensor to produce a reading, or can be self- contained. One version uses an attachable/detachable microneedle array as a single-use, disposable unit. The device is portable, and is used by placing one finger on the microneedle array, and actuating the diaphragm pump with another finger, thereby obtaining the fluid sample. Solid coated or transparent microneedles could instead be used as an in-situ sensor, with either electrodes or an optical sensor.

Claims (10)

  1. What is claimed is:

    I . A fluid sampling apparatus characterized by:

    (a) a plurality of microneedles accessible on a first surface of said fluid sampling apparatus;

    (b) a manually-operated pumping apparatus accessible on a second surface of said fluid sampling apparatus; and (c) a reservoir that is in hydraulic communication with both said plurality of microneedles and said pumping apparatus;
    wherein said reservoir receives fluid that flows through said plurality of microneedles upon manual actuation of said pumping apparatus.
  2. 2. The fluid sampling apparatus as recited in claim 1, further comprising: a fluidic passageway that is in hydraulic communication with said plurality of microneedles and said reservoir; and wherein said first surface is located on a first end of said fluid sampling apparatus, and said second surface is located on a second end of said fluid sampling apparatus that is distal from said first end.
  3. 3. The fluid sampling apparatus as recited in claim 1, wherein said first surface is located on a first side of said fluid sampling apparatus, and said second surface is located on a second side of said fluid sampling apparatus, in which said first side is opposite from said second side.
  4. 4. The fluid sampling apparatus as recited in claim 3, further comprising: (a) a member having a first end proximal to said reservoir and extending to a second end distal from said reservoir, (b) at least one electrode positioned on said extending member, and (c) a sensor pad that is in hydraulic communication with said reservoir; and wherein said at least one electrode is in communication with said sensor pad.
  5. 5. The fluid sampling apparatus as recited in claim 4, further comprising: an electrical interface that converts an output of said sensor pad into an electrical signal; a processing circuit that detects a value of said electrical signal and generates an output signal; and a display device that indicates a value representative of said output signal.
  6. 6. A fluid sensing apparatus characterized by:

    (a) a plurality of solid microneedles accessible on a first surface of said fluid sensing apparatus, said solid microneedles being coated on an exterior surface; whereupon said solid microneedles making contact with a biological barrier, said coating on said microneedles acting as an transducer responsive to a property of a fluid of said biological barrier, and thereby generating an electrical signal in response to said fluid property;
    (b) a member having a first end proximal to said coated microneedles and extending to a second end distal from said coated microneedles; and (c) at least one electrode positioned on said extending member, wherein said at least one electrode is in communication with said coated microneedles.
  7. 7. The fluid sensing apparatus as recited in claim 6, further comprising: an electrical interface that converts an output of said at least one electrode into an electrical signal; a processing circuit that detects a value of said electrical signal and generates an output signal; and a display device that indicates a value of said output signal.
  8. 8. A fluid sampling apparatus characterized by:

    (a) an attachableldetachable portion that includes a plurality of microneedles, a reservoir, an electrochemical sensor pad, and at least one electrode in communication with said sensor pad; and (b) a main body portion that includes a receptacle to receive said attachable/detachable portion such that, when in position, the at least one electrode faces said main body portion arid the plurality of microneedles are accessible; an electrical sensor; and a manually-operated pumping apparatus accessible on a surface of said main body portion;
    wherein said reservoir receives fluid that flows through said plurality of microneedles upon manual actuation of said pumping apparatus, and said electrochemical sensor pad exhibits a change in a physical property that is detected by said at least one electrode which outputs an electrical signal, and said electrical sensor is in communication with said at least one electrode and generates an output signal in response to said electrical signal.
  9. 9. The fluid sampling apparatus as recited in claim 8, wherein said manually-operated pumping apparatus comprises a pushbutton-like device, which: (a) is actuated at least once to cause a pressure differential that withdraws fluid through said microneedles, or (b) is pre-cocked in a first position, and then released by said manual actuation to move to a second position that causes a pressure differential that withdraws fluid through said microneedles.
  10. 10. A replaceable cartridge characterized by:
    a plurality of microneedle strips attached to a movable substrate of material, each of said microneedle strips including: a plurality of microneedles accessible to a user, a sensor that is in communication with a fluid that flows through said microneedles, and a signal transducer that is in communication with said sensor;

    wherein said signal transducer of a first of the plurality of microneedle strips generates an electrical signal that is communicated to an output port, and wherein said movable substrate of material is indexable to a next position that will make a second of the plurality of microneedle strips accessible to a user.
CA2446637A 2001-05-11 2002-05-09 Portable interstitial fluid monitoring system Expired - Lifetime CA2446637C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/853,442 2001-05-11
US09/853,442 US6591124B2 (en) 2001-05-11 2001-05-11 Portable interstitial fluid monitoring system
PCT/US2002/014624 WO2002091922A1 (en) 2001-05-11 2002-05-09 Portable interstitial fluid monitoring system

Publications (2)

Publication Number Publication Date
CA2446637A1 true CA2446637A1 (en) 2002-11-21
CA2446637C CA2446637C (en) 2012-01-03

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CA2446637A Expired - Lifetime CA2446637C (en) 2001-05-11 2002-05-09 Portable interstitial fluid monitoring system

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US (1) US6591124B2 (en)
EP (1) EP1385427B1 (en)
JP (2) JP4257123B2 (en)
AT (1) ATE429854T1 (en)
CA (1) CA2446637C (en)
DE (1) DE60232144D1 (en)
WO (1) WO2002091922A1 (en)

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