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WO2006050033B1 - System and method for analyte sampling and analysis - Google Patents

System and method for analyte sampling and analysis

Info

Publication number
WO2006050033B1
WO2006050033B1 PCT/US2005/038786 US2005038786W WO2006050033B1 WO 2006050033 B1 WO2006050033 B1 WO 2006050033B1 US 2005038786 W US2005038786 W US 2005038786W WO 2006050033 B1 WO2006050033 B1 WO 2006050033B1
Authority
WO
WIPO (PCT)
Prior art keywords
monitoring system
analyte
biological membrane
transdermal
analyte monitoring
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/US2005/038786
Other languages
French (fr)
Other versions
WO2006050033A2 (en
WO2006050033A3 (en
WO2006050033A9 (en
Inventor
Scott C Kellogg
Han Chuang
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.)
Sontra Medical Corp
Original Assignee
Sontra Medical Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US11/223,960 external-priority patent/US20060094945A1/en
Application filed by Sontra Medical Corp filed Critical Sontra Medical Corp
Publication of WO2006050033A2 publication Critical patent/WO2006050033A2/en
Publication of WO2006050033A3 publication Critical patent/WO2006050033A3/en
Publication of WO2006050033B1 publication Critical patent/WO2006050033B1/en
Publication of WO2006050033A9 publication Critical patent/WO2006050033A9/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61B5/6802—Sensor mounted on worn items
    • A61B5/681—Wristwatch-type devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or 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 or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14507—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
    • A61B5/1451—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue 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 or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or 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 or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means 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
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150053—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
    • A61B5/150083—Means for enhancing collection by vibration, e.g. ultrasound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150358—Strips for collecting blood, e.g. absorbent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150969—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
    • 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
    • A61B5/15134—Bladeless capillary blood sampling devices, i.e. devices for perforating the skin in order to obtain a blood sample but not using a blade, needle, canula, or lancet, e.g. by laser perforation, suction or pressurized 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
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B2010/0003—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements including means for analysis by an unskilled person

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biophysics (AREA)
  • Hematology (AREA)
  • Dermatology (AREA)
  • Optics & Photonics (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pain & Pain Management (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

The invention relates to a transdermal analyte monitoring system comprising a medium adapted to interface with a biological membrane and to receive an analyte from the biological membrane and an electrode assembly comprising a plurality of electrodes, wherein the medium is adapted to react continuously with the analyte, an electrical signal is detected by the electrode assembly, and the electrical signal correlates to an analyte value. The analyte value may be the flux of the analyte through the biological membrane or the concentration of the analyte in a body fluid of a subject. The medium may comprise a vinyl acetate based hydrogel, an agarose based hydrogel, or a polyethylene glycol diacrylate (PEG-DA) based hydrogel, for example. The surface region of the electrode may comprise pure platinum. The system may include an interference filter located between the biological membrane and the electrode assembly for reducing interference in the system. The system may comprise a processor programmed to implement an error correction method that corrects for sensor drift.

Claims

AMENDED CLAIMS Received by the International Bureau on 19 September 2006 (19.09.2006)
1. A transdermal analyte monitoring system comprising: a medium adapted to interface with a biological membrane and to receive an analyte from the biological membrane; and an substantially planar electrode assembly comprising a plurality of electrodes, wherein a surface region of at least one of the electrode consists essentially of pure platinum; wherein the medium is adapted to react continuously with the analyte; and wherein an electrical signal is detected by the electrode assembly, and the electrical signal correlates to an analyte value.
2. The transdermal analyte monitoring system of claim 1, wherein the analyte value is the flux of the analyte through the biological membrane.
3. The transdermal analyte monitoring system of claim 1, wherein the analyte value is the concentration of the analyte in a body fluid of a subject.
4. The transdermal analyte monitoring system of claim 1, further comprising a sensor body that supports the electrode assembly and the medium.
5. The transdermal analyte monitoring system of claim 1, wherein the analyte comprises glucose.
6. The transdermal analyte monitoring system of claim 5, wherein the medium comprises a hydrogel.
7. The transdermal analyte monitoring system of claim 6, wherein the medium further comprises glucose oxidase.
8. The transdermal analyte monitoring system of claim 5, wherein the surface region consisting essentially of pure platinum provides an increased signal representative of glucose concentration as compared with a signal from a surface region comprising platinized carbon.
9. The transdermal analyte monitoring system of claim 5, wherein the surface region consisting essentially of pure platinum provides an increased signal representative of a rate of production of hydrogen peroxide as compared with a signal from a surface region comprising platinized carbon.
10. The transdermal analyte monitoring system of claim 1, further comprising an interference filter located between the biological membrane and the electrode for reducing interference in the transdermal analyte monitoring system.
11. The transdermal analyte monitoring system of claim 10, wherein the interference filter comprises a biocompatible anionic fiuoropolymer.
46
12. The transdermal analyte monitoring system of claim 1, wherein the biological membrane comprises skin.
13. The transdermal analyte monitoring system of claim 1, wherein the electrode assembly comprises a working electrode, a counter electrode, and a reference electrode.
14. A transdermal analyte monitoring system comprising: a medium adapted to interface with a biological membrane and to receive an analyte from the biological membrane; an electrode assembly; and an interference filter located between the biological membrane and the electrode assembly for reducing interference from non-target biological moieties in the transdermal analyte monitoring system.
15. The transdermal analyte monitoring system of claim 14, wherein the medium is adapted to react continuously with the analyte, an electrical signal is detected by the electrode assembly, and the electrical signal correlates to an analyte value.
16. The transdermal analyte monitoring system of claim 14, wherein the interference filter comprises a biocompatible anionic fluoropolymer.
17. The transdermal analyte monitoring system of claim 14, wherein the interference filter comprises Nafion.
18. The transdermal analyte monitoring system of claim 14, wherein the interference filter is selected from the group consisting of: (3-mercaptopropyi)trimethylsilane, cellulose acetate, 1,8- diaminonapthaline, phenylenediamine, and a PTFE membrane., a hydrophobic membrane. Nylon and a hydrophylic mombrano.
19. The transdermal analyte monitoring system of claim 14, wherein the interference filter located between the electrode assembly and the medium.
20. The transdermal analyte monitoring system of claim 14, where the interference filter is disposed on a surface of an electrode in the electrode assembly.
21. The transdermal analyte monitoring system of claim 14, where the interference filter is disposed on an outer surface of the electrode assembly that contacts the biological membrane in operation.
22. The transdermal analyte monitoring system of claim 15, wherein the analyte value is the flux of the analyte through the biological membrane.
23. The transdermal analyte monitoring system of claim 15, wherein the analyte value is the concentration of the analyte in a body fluid of a subject.
47
24. The transdermal analyte monitoring system of claim 14, wherein the analyte comprises glucose.
25. The transdermal analyte monitoring system of claim 24, wherein the medium comprises a hydrogel and glucose oxidase.
26. The transdermal analyte monitoring system of claim 14, wherein the interference filter reduces interference effects from unwanted electrochemical oxidation.
27. The transdermal analyte monitoring system of claim 14, wherein the interference filter reduces an anodic signal produced by electrochemical oxidation of ascorbic acid, uric acide, or acetaminophen.
28. The transdermal analyte monitoring system of claim 14, wherein the interference filter reduces biofouling.
29. A method for monitoring an analyte comprising: positioning a medium with respect to a biological membrane such that the medium can receive an analyte from the biological membrane, wherein as substantially planar electrode assembly is coupled to the medium, the electrode assembly comprises a plurality of electrodes, and at least one of the electrodes comprises a surface region consisting essentially of pure platinum; continuously reacting the analyte with the medium; and detecting an electrical signal with the electrode assembly, wherein the electrical signal correlates to an analyte value.
30. The method of claim 29, further comprising pretreating the biological membrane to increase a permeability of the biological membrane.
31. The method of claim 30, wherein the pretreating step comprises applying low frequency ultrasound to the biological membrane.
32. The method of claim 29, wherein the surface region consisting essentially of pure platinum provides an increased signal representative of glucose concentration as compared with a signal from a surface region comprising platinized carbon.
33. The method of claim 29, wherein the surface region consisting essentially of pure platinum provides an increased signal representative of a rate of production of hydrogen peroxide as compared with a signal from a surface region comprising platinized carbon.
34. A method for monitoring an analyte comprising: positioning a medium with respect to a biological membrane such that the medium can receive an analyte from the biological membrane, wherein aa substantially planar electrode
48 assembly is coupled to the medium and an interference filter is positioned between an electrode in the electrode assembly and the biological membrane; continuously reacting the analyte with the medium; and detecting an electrical signal with the electrode assembly, wherein the electrical signal correlates to an analyte value.
35. The method of claim 34, further comprising pretreating the biological membrane to increase a permeability of the biological membrane.
36. The method of claim 35, wherein the pretreating step comprises applying low frequency ultrasound to the biological membrane.
37. The method of claim 34, wherein the interference filter comprises Nafion.
38. The method of claim 34, wherein the interference filter is selected from the group consisting of: (3-mercaptopropyl)trimethylsilane, cellulose acetate, 1,8-diaminonapthaline, phenyl enediamine, and a PTFE membrane., a hydrophobic membrane. Nylon and a hydrophylic membrane..
39. The method of claim 34, wherein the interference filter reduces interference effects from unwanted electrochemical oxidation.
40. The method of claim 34, wherein the interference filter reduces an anodic signal produced by electrochemical oxidation of ascorbic acid, uric acide, or acetaminophen.
41. The method of claim 34, wherein the interference filter reduces biofouling.
PCT/US2005/038786 2004-10-28 2005-10-27 System and method for analyte sampling and analysis Ceased WO2006050033A2 (en)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US97496304A 2004-10-28 2004-10-28
US10/974,963 2004-10-28
US20133405A 2005-08-11 2005-08-11
US11/201,334 2005-08-11
US11/223,960 2005-09-13
US11/223,960 US20060094945A1 (en) 2004-10-28 2005-09-13 System and method for analyte sampling and analysis
US11/223,971 US8224414B2 (en) 2004-10-28 2005-09-13 System and method for analyte sampling and analysis with hydrogel
US11/223,957 US20060094944A1 (en) 2004-10-28 2005-09-13 System and method for analyte sampling and analysis with error correction

Publications (4)

Publication Number Publication Date
WO2006050033A2 WO2006050033A2 (en) 2006-05-11
WO2006050033A3 WO2006050033A3 (en) 2006-11-02
WO2006050033B1 true WO2006050033B1 (en) 2006-12-14
WO2006050033A9 WO2006050033A9 (en) 2007-02-01

Family

ID=38441686

Family Applications (3)

Application Number Title Priority Date Filing Date
PCT/US2005/038784 Ceased WO2006050031A2 (en) 2004-10-28 2005-10-27 System and method for analyte sampling and analysis with error correction
PCT/US2005/038785 Ceased WO2006050032A2 (en) 2004-10-28 2005-10-27 System and method for analyte sampling and analysis with hydrogel
PCT/US2005/038786 Ceased WO2006050033A2 (en) 2004-10-28 2005-10-27 System and method for analyte sampling and analysis

Family Applications Before (2)

Application Number Title Priority Date Filing Date
PCT/US2005/038784 Ceased WO2006050031A2 (en) 2004-10-28 2005-10-27 System and method for analyte sampling and analysis with error correction
PCT/US2005/038785 Ceased WO2006050032A2 (en) 2004-10-28 2005-10-27 System and method for analyte sampling and analysis with hydrogel

Country Status (4)

Country Link
EP (1) EP1819283A4 (en)
AU (1) AU2005302584B2 (en)
CA (1) CA2584699C (en)
WO (3) WO2006050031A2 (en)

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US9216188B2 (en) 2008-09-04 2015-12-22 The General Hospital Corporation Hydrogels for vocal cord and soft tissue augmentation and repair
US9198568B2 (en) 2010-03-04 2015-12-01 The General Hospital Corporation Methods and systems of matching voice deficits with a tunable mucosal implant to restore and enhance individualized human sound and voice production

Also Published As

Publication number Publication date
CA2584699C (en) 2015-12-08
WO2006050033A2 (en) 2006-05-11
WO2006050032A3 (en) 2006-09-08
WO2006050032A9 (en) 2006-11-02
WO2006050033A3 (en) 2006-11-02
WO2006050031A2 (en) 2006-05-11
AU2005302584B2 (en) 2011-08-11
WO2006050031A3 (en) 2007-05-18
EP1819283A2 (en) 2007-08-22
WO2006050033A9 (en) 2007-02-01
EP1819283A4 (en) 2011-08-10
WO2006050031A9 (en) 2006-06-15
WO2006050032A2 (en) 2006-05-11
AU2005302584A1 (en) 2006-05-11
CA2584699A1 (en) 2006-05-11

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