WO2003066128A3 - Autonomous, ambulatory analyte monitor or drug delivery device - Google Patents

Autonomous, ambulatory analyte monitor or drug delivery device Download PDF

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Publication number
WO2003066128A3
WO2003066128A3 PCT/US2003/003536 US0303536W WO03066128A3 WO 2003066128 A3 WO2003066128 A3 WO 2003066128A3 US 0303536 W US0303536 W US 0303536W WO 03066128 A3 WO03066128 A3 WO 03066128A3
Authority
WO
WIPO (PCT)
Prior art keywords
microneedle
delivery device
ambulatory
autonomous
drug delivery
Prior art date
Application number
PCT/US2003/003536
Other languages
French (fr)
Other versions
WO2003066128A2 (en
Inventor
John Gregory Aceti
Sterling Eduard Mcbride
Richard Morgan Moroney Iii
Christopher Carter Gregory
Peter John Zanzucchi
Original Assignee
Rosedale Medical Inc
John Gregory Aceti
Sterling Eduard Mcbride
Richard Morgan Moroney Iii
Christopher Carter Gregory
Peter John Zanzucchi
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 Rosedale Medical Inc, John Gregory Aceti, Sterling Eduard Mcbride, Richard Morgan Moroney Iii, Christopher Carter Gregory, Peter John Zanzucchi filed Critical Rosedale Medical Inc
Priority to CA2476308A priority Critical patent/CA2476308C/en
Priority to EP11195415.2A priority patent/EP2471570B1/en
Priority to AU2003215064A priority patent/AU2003215064A1/en
Priority to EP03710880.0A priority patent/EP1480710B1/en
Priority to DK03710880.0T priority patent/DK1480710T3/en
Priority to JP2003565550A priority patent/JP4856849B2/en
Publication of WO2003066128A2 publication Critical patent/WO2003066128A2/en
Publication of WO2003066128A3 publication Critical patent/WO2003066128A3/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532Measuring 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150977Arrays of piercing elements for simultaneous piercing
    • A61B5/150984Microneedles or microblades
    • AHUMAN NECESSITIES
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    • A61B5/14Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
    • A61B5/1405Devices for taking blood samples
    • A61B5/1411Devices for taking blood samples by percutaneous method, e.g. by lancet
    • AHUMAN NECESSITIES
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    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14507Measuring 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
    • A61B5/1451Measuring 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
    • A61B5/14514Measuring 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
    • AHUMAN NECESSITIES
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    • A61B5/14546Measuring 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
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    • A61B5/1455Measuring 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
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    • A61B5/150022Source of blood for capillary blood or interstitial fluid
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    • A61B5/150061Means for enhancing collection
    • A61B5/150076Means for enhancing collection by heating
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    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150213Venting means
    • AHUMAN NECESSITIES
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    • A61B5/150389Hollow piercing elements, e.g. canulas, needles, for piercing the skin
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    • A61B5/150007Details
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    • A61B5/15087Communication to or from blood sampling device short range, e.g. between console and disposable
    • AHUMAN NECESSITIES
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    • A61B5/150969Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101Details
    • A61B5/15103Piercing procedure
    • A61B5/15107Piercing being assisted by a triggering mechanism
    • A61B5/15109Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101Details
    • A61B5/15115Driving 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
    • A61B5/15119Driving 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 shape memory alloys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/00Measuring for diagnostic purposes; Identification of persons
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    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101Details
    • A61B5/15115Driving 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
    • A61B5/15123Driving 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 magnets or solenoids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15146Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • AHUMAN NECESSITIES
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    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15146Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/15148Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
    • A61B5/15149Arrangement of piercing elements relative to each other
    • A61B5/15153Multiple piercing elements stocked in a single compartment
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    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15146Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/15148Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
    • A61B5/15157Geometry of stocking means or arrangement of piercing elements therein
    • A61B5/15159Piercing elements stocked in or on a disc
    • A61B5/15163Characterized by propelling the piercing element in an axial direction relative to the disc
    • AHUMAN NECESSITIES
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    • A61B5/15Devices for taking samples of blood
    • A61B5/155Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals
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    • A61B5/157Devices characterised by integrated means for measuring characteristics of blood
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    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements 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
    • A61B5/6802Sensor mounted on worn items
    • A61B5/681Wristwatch-type devices
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    • A61B5/6801Arrangements 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
    • A61B5/683Means for maintaining contact with the body
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    • A61B5/6833Adhesive patches
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    • A61MDEVICES 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
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/49Blood
    • G01N33/491Blood by separating the blood components
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    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0023Drug applicators using microneedles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0038Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a channel at the side surface
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M2209/00Ancillary equipment
    • A61M2209/08Supports for equipment
    • A61M2209/088Supports for equipment on the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2230/00Measuring parameters of the user
    • A61M2230/20Blood composition characteristics
    • A61M2230/201Glucose concentration

Abstract

The invention relates to analyte monitoring/drug (pharmaceutical agent) delivery device (10). The invention is suited for monitoring various blood constituents such as glucose. The device has a housing (12) that at least partially encloses a plurality of microneedles (14) disposed on a carrier (16) and an electronics portion (18). Each microneedle (14) is in fluid communication with a corresponding microchannel (20). Each microneedle (14) is individually addressable. That is, each microneedle (14) can be extended and retracted individually via an actuator (22). The electronics portion (18) includes a processor (30) and associated circuitry (e.g., memory, supporting electronics and the like), a motor (32) or the like, a sensor (34), a power supply (e.g., battery) (36) and optionally an interface (38). In general, the processor (30) controls the operation of the device (10) and is data communication with the actuator (22), motor (34) and interface.
PCT/US2003/003536 2002-02-08 2003-02-07 Autonomous, ambulatory analyte monitor or drug delivery device WO2003066128A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
CA2476308A CA2476308C (en) 2002-02-08 2003-02-07 Autonomous, ambulatory analyte monitor or drug delivery device
EP11195415.2A EP2471570B1 (en) 2002-02-08 2003-02-07 Autonomous, ambulatory analyte monitor
AU2003215064A AU2003215064A1 (en) 2002-02-08 2003-02-07 Autonomous, ambulatory analyte monitor or drug delivery device
EP03710880.0A EP1480710B1 (en) 2002-02-08 2003-02-07 Autonomous, ambulatory analyte monitor
DK03710880.0T DK1480710T3 (en) 2002-02-08 2003-02-07 AUTONOMY, AMBULANT ANALYTICAL MONITOR
JP2003565550A JP4856849B2 (en) 2002-02-08 2003-02-07 Autonomous portable sample monitoring device or drug delivery device

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US35519502P 2002-02-08 2002-02-08
US60/355,195 2002-02-08
US10/131,268 US7004928B2 (en) 2002-02-08 2002-04-23 Autonomous, ambulatory analyte monitor or drug delivery device
US10/131,268 2002-04-23

Publications (2)

Publication Number Publication Date
WO2003066128A2 WO2003066128A2 (en) 2003-08-14
WO2003066128A3 true WO2003066128A3 (en) 2003-12-11

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2003/003536 WO2003066128A2 (en) 2002-02-08 2003-02-07 Autonomous, ambulatory analyte monitor or drug delivery device

Country Status (7)

Country Link
US (4) US7004928B2 (en)
EP (3) EP2471570B1 (en)
JP (2) JP4856849B2 (en)
AU (1) AU2003215064A1 (en)
CA (1) CA2476308C (en)
DK (1) DK1480710T3 (en)
WO (1) WO2003066128A2 (en)

Cited By (26)

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US7648468B2 (en) 2002-04-19 2010-01-19 Pelikon Technologies, Inc. Method and apparatus for penetrating tissue
US7674232B2 (en) 2002-04-19 2010-03-09 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7708701B2 (en) 2002-04-19 2010-05-04 Pelikan Technologies, Inc. Method and apparatus for a multi-use body fluid sampling device
US7717863B2 (en) 2002-04-19 2010-05-18 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7888125B2 (en) 2005-05-09 2011-02-15 Theranos, Inc. Calibration of fluidic devices
US7901362B2 (en) 2002-04-19 2011-03-08 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US8007999B2 (en) 2006-05-10 2011-08-30 Theranos, Inc. Real-time detection of influenza virus
US8158430B1 (en) 2007-08-06 2012-04-17 Theranos, Inc. Systems and methods of fluidic sample processing
US8690796B2 (en) 2002-04-19 2014-04-08 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8741230B2 (en) 2006-03-24 2014-06-03 Theranos, Inc. Systems and methods of sample processing and fluid control in a fluidic system
US8778665B2 (en) 2006-11-14 2014-07-15 Theranos, Inc. Detection and quantification of analytes in bodily fluids
US8795201B2 (en) 2005-09-30 2014-08-05 Intuity Medical, Inc. Catalysts for body fluid sample extraction
US8845549B2 (en) 2002-04-19 2014-09-30 Sanofi-Aventis Deutschland Gmbh Method for penetrating tissue
US8845550B2 (en) 2001-06-12 2014-09-30 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US8905945B2 (en) 2002-04-19 2014-12-09 Dominique M. Freeman Method and apparatus for penetrating tissue
US8919605B2 (en) 2009-11-30 2014-12-30 Intuity Medical, Inc. Calibration material delivery devices and methods
US8945910B2 (en) 2003-09-29 2015-02-03 Sanofi-Aventis Deutschland Gmbh Method and apparatus for an improved sample capture device
US8965476B2 (en) 2010-04-16 2015-02-24 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US8969097B2 (en) 2005-06-13 2015-03-03 Intuity Medical, Inc. Analyte detection devices and methods with hematocrit-volume correction and feedback control
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US7004928B2 (en) 2006-02-28
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US10772550B2 (en) 2020-09-15
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US20130158430A1 (en) 2013-06-20
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AU2003215064A8 (en) 2003-09-02

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