WO1995002357A1 - Noninvasive glucose monitor - Google Patents
Noninvasive glucose monitor Download PDFInfo
- Publication number
- WO1995002357A1 WO1995002357A1 PCT/US1994/006684 US9406684W WO9502357A1 WO 1995002357 A1 WO1995002357 A1 WO 1995002357A1 US 9406684 W US9406684 W US 9406684W WO 9502357 A1 WO9502357 A1 WO 9502357A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- glucose
- patient
- skin
- collection medium
- reservoir
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—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
Definitions
- This invention relates generally to methods and apparatus for glucose collection and concentration measurement.
- the invention is directed to a method and apparatus for monitoring blood glucose levels noninvasively through a patient's skin.
- U.S. Patent No. 5,036,861 describes a glucose monitor that collects the patient's sweat through a skin patch attached to the patient's wrist. Iontophoresis is used to transdermally introduce a gel into the patient's skin. The gel contains a cholinergic agent for stimulating the secretion mechanism of the eccrine sweat gland and agents that minimize or prevent loss of glucose from the sweat as it travels from the sweat gland to the skin patch. As in the '532 patent, the device described in the '861 patent measures the glucose level in the collected sweat using electrodes.
- U.S. Patent No. 5,139,023 describes yet another "noninvasive" apparatus and method for monitoring blood glucose.
- the monitor includes a glucose receiving medium such as water enclosed in a housing that holds the receiving medium against the patient's epithelial membrane.
- the glucose receiving medium includes a permeation enhancing chemical such as a natural bile salt that enhances glucose permeability from interstitial fluid across the epithelial membrane into the monitor.
- published European Patent Application EP 0 304 304 discloses a transdermal glucose detection system in which the detector contains a porous carrier saturated with detector chemicals.
- the detector adhesively attaches to the patient's skin.
- a membrane serves as a barrier to prevent migration of the detector chemicals out of the detector while permitting glucose to migrate into the detector. Interaction between glucose and the detector chemicals causes a perceivable color change over a six to twelve hour period.
- the device only detects the presence of glucose; it does not measure the actual amount of glucose in the detector.
- This invention provides a truly noninvasive glucose monitoring apparatus and method that does not rely upon heat, electricity or chemicals to collect glucose from interstitial fluid across the patient's skin. Moreover, the method and apparatus of this invention monitor blood glucose in real time, that is to say, in a time period short enough to enable a diabetic to take appropriate action to correct blood glucose levels.
- a collection device comprising a reservoir containing a glucose collection medium such as water is placed against the stratum corneum of the patient's skin for a predetermined period of time. At least a portion of the glucose collection medium is removed from the reservoir at the end of the predetermined time and analyzed for glucose concentration.
- a glucose collection medium such as water
- Figure 1 is a side cross-sectional view of a glucose collection device according to the preferred embodiment of this invention.
- Figure 2 is a bottom elevational view of the preferred glucose collection device.
- Figure 3 is a cross-sectional view of a sensor for use with a glucose analysis method for use with this invention.
- FIG. 4 is a schematic representation of a glucose monitoring system according to this invention.
- This invention presents a simple and noninvasive method for monitoring blood glucose levels. It is well-known that glucose can be found in a patient's interstitial fluid and in a patient's sweat. Heretofore, however, it had been thought that glucose could not cross the patient's skin in a detectable amount in real time without the use of a permeability enhancer. See, e.g., U.S. Patent No. 5,139,023 at col. 7, line 3. It had also been thought that even when sweat or interstitial fluid is actively extracted from the patient, active pharmacological agents are needed to preserve the presence of glucose in the extracted sample. See, e.g., U.S. Patent No. 5,036,861, col. 3, lines 1-10.
- This invention is a method and apparatus for detecting blood glucose in a truly noninvasive manner without actively extracting interstitial fluid from the patient and without the use of sweat inducers, glucose preservers or permeability enhancers.
- glucose is collected through the stratum corneum of the patient's skin by a reservoir containing a glucose collection medium. After the passage of a predetermined time period, the glucose collection medium is analyzed to measure the quantity of glucose present.
- a preferred collection device for practicing this invention is shown in Figures 1 and 2.
- the device 10 comprises a reservoir 12 bordered by a cover 14, adhesive layer 16, and the stratum corneum of the patient's skin 18.
- the device is formed by attaching the plastic cover 14 to a double-sided adhesive 16 in which an oval or other-shaped hole has been formed.
- cover 14 is formed from cellophane plastic and adhesive layer 16 is Avery double-sided adhesive, part no. MED 3044.
- the preferred glucose collection medium is distilled deionized water.
- the distilled deionized water is injected into reservoir 12 through a hypodermic needle and syringe 20.
- glucose will migrate from the patient's interstitial fluid through the skin 18 and into the water within reservoir 12. After the water has rested against the patient's skin for a predetermined period of time, the water is withdrawn for analysis.
- This glucose collection device and method can collect glucose from the patient without the use of chemicals or mechanical extraction.
- hydrogel may be used as a collection medium. Suitable hydrogels are described in U.S. Patent No. 5,139,023.
- Water (or other collection medium) from the reservoir may be extracted at periodic intervals (preferably in the range of 5 to 10 minutes) and analyzed to determine its glucose content.
- a preferred glucose analysis method is described by LaCourse et al. in "Optimization of Waveforms for Pulsed Amperometric Detection of Carbohydrates Based on Pulsed Voltammetry, " 65 Analytical Chemistry 50-55 (1 January 1993) , although other analysis methods may be used.
- the preferred pulse amperometric voltammetry (PAD) analysis method combines high performance liquid chromatography with electrochemical detection using bi-directional voltage waveforms. Specifically, water extracted from the reservoir is diffused onto a chromatography column. The column is washed with a high pressure solvent such as a NaOH solution.
- a stepped voltage waveform is applied across two electrodes in the solution, one of which is a gold rotating disk electrode.
- the voltage waveform has three parts: a detection potential in the range of -200 to +400 mV for greater than 40 ms detection period, an oxidation potential in the range of 300 to 800 mV for greater than approximately 60 ms, and a reduction potential in the range of -800 to +100 mV for greater than approximately 60 ms.
- a plot of electrode current at the gold electrode versus applied voltage yields a curve with signature peaks at specific voltage values for certain solutes such as glucose. The peak amplitude or peak area are measures of the concentration of that solute.
- An alternative glucose concentration analysis method is shown schematically in Figures 3 and 4.
- the glucose measurement technique of this embodiment is similar to the enzymatic technique described in U.S. Patent No. 5,165,407 and does not require the glucose collection medium to be extracted from the collection device.
- a glucose sensor 30 is shown in detail in Figure 3.
- a sensor body 32 is received within a stainless steel hollow tubular needle 34.
- the sensor body includes a Teflon-coated platinum-iridium wire 36
- a glucose oxidase layer 40 is immobilized within the cavity 38, and comprises a cellulose acetate polymer layer attached to the surface of the Pt-Ir wire, with glucose oxidase crosslinked through glutaraldehyde onto the cellulose acetate to form an indicating electrode.
- the procedure is described in more detail in U.S. Patent No. 5,165,407.
- the entirety of the indicating electrode is covered by a membrane 42 of polyurethane, also as described in U.S. Patent No.
- FIG. 4 is a schematic representation of a glucose collection and measurement system using this alternative glucose analysis method.
- the sensor 30 described above with reference to Figure 3 is inserted into a glucose collection device attached to the patient's skin 18 as described with reference to Figures 1 and 2 above so that the sensor's aperture 44 is exposed to the glucose collection medium 12.
- a conductor 60 leads from the indicating electrode of sensor 30 to a glucose measurement instrument 62.
- a second conductor 64 leads from a reference electrode 66 attached to the patient's skin 18. Instrument 62 applies a voltage across conductors 60 and 64; the current measured across the electrodes is related to the concentration of glucose in the collection medium in a manner known in the art.
- Glucose was collected from an adult human using an apparatus substantially similar to the apparatus shown in Figures 1 and 2.
- the device was attached to the stratum corneum of the skin on the patient's forearm, and the device's reservoir was initially filled with a sample consisting of 0.5 ml. of distilled deionized water via a hypodermic needle and syringe.
- the sample was withdrawn from the reservoir after five minutes and was replaced with a fresh sample of distilled deionized water at five minute intervals for a total of 30 minutes.
- the final sample remained in the reservoir for 30 minutes before being withdrawn and analyzed.
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP7504544A JPH09503924A (en) | 1993-07-16 | 1994-06-14 | Non-invasive glucose monitor |
EP94920190A EP0708615A4 (en) | 1993-07-16 | 1994-06-14 | Noninvasive glucose monitor |
AU71073/94A AU7107394A (en) | 1993-07-16 | 1994-06-14 | Noninvasive glucose monitor |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US9297593A | 1993-07-16 | 1993-07-16 | |
US08/092,975 | 1993-07-16 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1995002357A1 true WO1995002357A1 (en) | 1995-01-26 |
Family
ID=22236062
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1994/006684 WO1995002357A1 (en) | 1993-07-16 | 1994-06-14 | Noninvasive glucose monitor |
Country Status (5)
Country | Link |
---|---|
EP (1) | EP0708615A4 (en) |
JP (1) | JPH09503924A (en) |
AU (1) | AU7107394A (en) |
CA (1) | CA2167393A1 (en) |
WO (1) | WO1995002357A1 (en) |
Cited By (37)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1998004190A3 (en) * | 1996-07-30 | 1998-06-25 | Dtr Dermal Therapy Inc | Method and apparatus for non-invasive determination of glucose in body fluids |
US5954685A (en) * | 1996-05-24 | 1999-09-21 | Cygnus, Inc. | Electrochemical sensor with dual purpose electrode |
US6144869A (en) * | 1998-05-13 | 2000-11-07 | Cygnus, Inc. | Monitoring of physiological analytes |
US6180416B1 (en) | 1998-09-30 | 2001-01-30 | Cygnus, Inc. | Method and device for predicting physiological values |
US6233471B1 (en) | 1998-05-13 | 2001-05-15 | Cygnus, Inc. | Signal processing for measurement of physiological analysis |
US6251083B1 (en) | 1999-09-07 | 2001-06-26 | Amira Medical | Interstitial fluid methods and devices for determination of an analyte in the body |
US6272364B1 (en) | 1998-05-13 | 2001-08-07 | Cygnus, Inc. | Method and device for predicting physiological values |
US6284126B1 (en) | 1997-03-25 | 2001-09-04 | Cygnus, Inc. | Electrode with improved signal to noise ratio |
US6326160B1 (en) | 1998-09-30 | 2001-12-04 | Cygnus, Inc. | Microprocessors for use in a device for predicting physiological values |
US6341232B1 (en) | 1998-05-13 | 2002-01-22 | Cygnus, Inc. | Methods of producing collection assemblies, laminates, and autosensor assemblies for use in transdermal sampling systems |
US6391643B1 (en) | 1998-10-28 | 2002-05-21 | Cygnus, Inc. | Kit and method for quality control testing of an iontophoretic sampling system |
US6561978B1 (en) | 1999-02-12 | 2003-05-13 | Cygnus, Inc. | Devices and methods for frequent measurement of an analyte present in a biological system |
US6587705B1 (en) | 1998-03-13 | 2003-07-01 | Lynn Kim | Biosensor, iontophoretic sampling system, and methods of use thereof |
US6615078B1 (en) | 1999-04-22 | 2003-09-02 | Cygnus, Inc. | Methods and devices for removing interfering species |
US7150975B2 (en) | 2002-08-19 | 2006-12-19 | Animas Technologies, Llc | Hydrogel composition for measuring glucose flux |
US7497940B2 (en) | 2003-09-02 | 2009-03-03 | Koji Sode | Glucose sensor and glucose level measuring apparatus |
US7699775B2 (en) | 2001-06-22 | 2010-04-20 | Animas Technologies, Llc | Methods for estimating analyte-related signals, microprocessors comprising programming to control performance of the methods, and analyte monitoring devices employing the methods |
WO2010052849A1 (en) | 2008-11-04 | 2010-05-14 | パナソニック株式会社 | Measurement device, insulin infusion device, measurement method, method for controlling insulin infusion device, and program |
EP2255724A1 (en) | 2009-05-25 | 2010-12-01 | Sysmex Corporation | Method for analyzing analyte in tissue fluid, analyzer for analyzing analyte in tissue fluid, cartridge for analyzing analyte in tissue fluid, and kit for analyzing analyte in tissue fluid |
EP2329771A3 (en) * | 2004-07-13 | 2011-06-22 | DexCom, Inc. | Transcutaneous analyte sensor |
US8690775B2 (en) | 2004-07-13 | 2014-04-08 | Dexcom, Inc. | Transcutaneous analyte sensor |
US8747316B2 (en) | 2008-07-31 | 2014-06-10 | Sysmex Corporation | In vivo component measurement method, data processing method for in vivo component measurement, in vivo component measurement apparatus and collection member |
US8870810B2 (en) | 1998-12-18 | 2014-10-28 | Echo Therapeutics, Inc. | Method and apparatus for enhancement of transdermal transport |
US8886272B2 (en) | 2004-07-13 | 2014-11-11 | Dexcom, Inc. | Analyte sensor |
US9247901B2 (en) | 2003-08-22 | 2016-02-02 | Dexcom, Inc. | Systems and methods for replacing signal artifacts in a glucose sensor data stream |
US9247900B2 (en) | 2004-07-13 | 2016-02-02 | Dexcom, Inc. | Analyte sensor |
EP2998731A1 (en) * | 2014-09-17 | 2016-03-23 | i-Sens, Inc. | Apparatus and method for measuring concentration of an analyte in whole blood samples |
US9504413B2 (en) | 2006-10-04 | 2016-11-29 | Dexcom, Inc. | Dual electrode system for a continuous analyte sensor |
US9572527B2 (en) | 2007-04-27 | 2017-02-21 | Echo Therapeutics, Inc. | Skin permeation device for analyte sensing or transdermal drug delivery |
US9579053B2 (en) | 2003-12-05 | 2017-02-28 | Dexcom, Inc. | Dual electrode system for a continuous analyte sensor |
US9833143B2 (en) | 2004-05-03 | 2017-12-05 | Dexcom, Inc. | Transcutaneous analyte sensor |
US9986942B2 (en) | 2004-07-13 | 2018-06-05 | Dexcom, Inc. | Analyte sensor |
US10610137B2 (en) | 2005-03-10 | 2020-04-07 | Dexcom, Inc. | System and methods for processing analyte sensor data for sensor calibration |
US11432772B2 (en) | 2006-08-02 | 2022-09-06 | Dexcom, Inc. | Systems and methods for replacing signal artifacts in a glucose sensor data stream |
US11559260B2 (en) | 2003-08-22 | 2023-01-24 | Dexcom, Inc. | Systems and methods for processing analyte sensor data |
US11589823B2 (en) | 2003-08-22 | 2023-02-28 | Dexcom, Inc. | Systems and methods for replacing signal artifacts in a glucose sensor data stream |
US11633133B2 (en) | 2003-12-05 | 2023-04-25 | Dexcom, Inc. | Dual electrode system for a continuous analyte sensor |
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US8287483B2 (en) | 1998-01-08 | 2012-10-16 | Echo Therapeutics, Inc. | Method and apparatus for enhancement of transdermal transport |
US20060094945A1 (en) | 2004-10-28 | 2006-05-04 | Sontra Medical Corporation | System and method for analyte sampling and analysis |
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- 1994-06-14 WO PCT/US1994/006684 patent/WO1995002357A1/en not_active Application Discontinuation
- 1994-06-14 EP EP94920190A patent/EP0708615A4/en not_active Withdrawn
- 1994-06-14 JP JP7504544A patent/JPH09503924A/en active Pending
- 1994-06-14 CA CA 2167393 patent/CA2167393A1/en not_active Abandoned
- 1994-06-14 AU AU71073/94A patent/AU7107394A/en not_active Abandoned
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Cited By (127)
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US5890489A (en) * | 1996-04-23 | 1999-04-06 | Dermal Therapy (Barbados) Inc. | Method for non-invasive determination of glucose in body fluids |
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WO1998004190A3 (en) * | 1996-07-30 | 1998-06-25 | Dtr Dermal Therapy Inc | Method and apparatus for non-invasive determination of glucose in body fluids |
USRE38681E1 (en) * | 1997-03-25 | 2005-01-04 | Cygnus, Inc. | Electrode with improved signal to noise ratio |
US6284126B1 (en) | 1997-03-25 | 2001-09-04 | Cygnus, Inc. | Electrode with improved signal to noise ratio |
US6587705B1 (en) | 1998-03-13 | 2003-07-01 | Lynn Kim | Biosensor, iontophoretic sampling system, and methods of use thereof |
US6999810B2 (en) | 1998-03-13 | 2006-02-14 | Animas Technologies Llc | Biosensor and methods of use thereof |
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US8870810B2 (en) | 1998-12-18 | 2014-10-28 | Echo Therapeutics, Inc. | Method and apparatus for enhancement of transdermal transport |
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Also Published As
Publication number | Publication date |
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CA2167393A1 (en) | 1995-01-26 |
EP0708615A4 (en) | 1996-10-16 |
EP0708615A1 (en) | 1996-05-01 |
AU7107394A (en) | 1995-02-13 |
JPH09503924A (en) | 1997-04-22 |
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