CA2535394C - Method of constructing a biosensor - Google Patents

Method of constructing a biosensor Download PDF

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Publication number
CA2535394C
CA2535394C CA2535394A CA2535394A CA2535394C CA 2535394 C CA2535394 C CA 2535394C CA 2535394 A CA2535394 A CA 2535394A CA 2535394 A CA2535394 A CA 2535394A CA 2535394 C CA2535394 C CA 2535394C
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CA
Canada
Prior art keywords
sensor
electrochemically active
active surface
membrane system
nubs
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.)
Expired - Fee Related
Application number
CA2535394A
Other languages
French (fr)
Other versions
CA2535394A1 (en
Inventor
Lawrence B. Jansen
Kenneth W. Ward
Ellen M. Anderson
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.)
Bayer Healthcare LLC
Original Assignee
Isense 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
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=34136237&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2535394(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Isense Corp filed Critical Isense Corp
Publication of CA2535394A1 publication Critical patent/CA2535394A1/en
Application granted granted Critical
Publication of CA2535394C publication Critical patent/CA2535394C/en
Expired - Fee Related legal-status Critical Current
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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
    • A61B5/1486Measuring 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
    • A61B5/14865Measuring 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 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • 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
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/12Manufacturing methods specially adapted for producing sensors for in-vivo measurements
    • A61B2562/125Manufacturing methods specially adapted for producing sensors for in-vivo measurements characterised by the manufacture of electrodes
    • 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
    • A61B5/1468Measuring 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 chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1473Measuring 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 chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter

Abstract

A method of creating an analyte sensor (10). The method starts with the step of providing an electrochemically active surface (24). Then, at least one nub (22) made of dielectric material and extending transversely outwardly from the electrochemically active surface (24) is created. A curable liquid is applied to the electrochemically active surface and the nub (22) and is then cured. In this process, the nub (22), which could be one of several nubs (22), serves to support the liquid before and during the curing.

Description

METHOD OF CONSTRUCTING A BIOSENSOR
FIELD OF THE INVENTION
The invention is generally related to the field of percutaneous analyte sensors.
BACKGROUND ART
In the design and manufacture of an indwelling glucose sensor, a problem has been encountered in the application of viscous liquid layers of material, which are then cured, over the electrochemically active (platinum) surface. It is desirable to have an active surface area that is on the order of about a square millimeter.
Unfortunately, when dip coating viscous liquids onto this relatively large area, it has been quite difficult to construct a coating having a thickness sufficient to produce an adequate response to the presence of glucose.
DISCLOSURE OF THE INVENTION
In a first separate aspect, the present invention is an indwelling analyte sensor that has an active sensing region. This sensing region includes an electrochemically active surface and a membrane system that adheres to the electrochemically active surface. In addition, at least one nub of dielectric material extends outwardly from the electrochemically active surface and serves as a supportive structure to the membrane system.
In a second separate aspect, the present invention is a method of creating an analyte sensor. The method starts with the step of providing an electrochemically active surface. Then, at least one nub made of dielectric material and extending transversely outwardly from the electrochemically active surface is created. A curable liquid is applied to the electrochemically active surface and is then cured. In this process, the nub, which could be one of several nubs, serves to support the liquid before and during the curing.
The foregoing and other objectives, features and advantages of the invention will be more readily understood upon consideration of the following detailed description of the preferred embodiment(s), taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side view of a work piece formed as part of the construction of a biosensor using the method of the present invention.
FIG. 2 is a side view of a sensor constructed from the work piece of FIG. 1.
BEST MODE OF CARRYING OUT THE INVENTION
In a preferred embodiment of an analyte (typically glucose) sensor 10 (FIG.2) a 178 micron thick platinum wire 12 is coated with a 25 micron thick polyimide layer 14. A silver wire 16 is wrapped about a portion of layer 14. In addition, a stainless steel retractor lead 18 forms a portion of sensor 10.
Three cavities 20, each 2 mm long, are formed by laser ablating polyimide layer 14 to form a work piece 8 (FIG. 1). The polyimide between the cavities 20, forms a set of annular plates 22, that are supported by the adherence of the polyimide 14 onto wire 12. After this laser machining operation the work piece is ready to be dip coated with the material 24 that permits it to detect glucose. Typically, material 24 is comprised of a set of layers that are constructed through a sequence of dip coating operations interspersed with curing operations.
These layers typically include an interferent excluding layer, a glucose oxidase layer and a permselective layer.
The surface of each viscous fluid tends to form a shape somewhat like a catenary curve between plates 22.
Accordingly a greater portion of viscous fluid adheres than would adhere without the presence of plates 22. This greater thickness, especially for glucose oxidase layer is very important in the creation of a robust response to the presence of glucose and oxygen.
INDUSTRIAL APPLICABILITY
The invention generally finds industrial applicability in the production and providing of percutaneous analyte sensors.
The terms and expressions that have been employed in the foregoing specification are used as terms of description and not of limitation. There is no intention, in the use of such terms and expressions, of excluding equivalents of the features shown and described or portions thereof.

Claims (15)

1. An indwelling analyte sensor, comprising:
an electrochemically active surface;
a plurality of annular nubs of dielectric material extending outwardly from said electrochemically active surface; and a membrane system comprising an enzyme layer adhering to, and substantially covering, said electrochemically active surface and said plurality of annular nubs, wherein the plurality of annular nubs serves as a supportive structure for the membrane system.
2. The sensor of claim 1, wherein at least one of said plurality of annular nubs is in the form of a plate.
3. The sensor of claim 1, wherein said electrochemically active surface is defined as part of a lengthwise body.
4. The sensor of claim 3, wherein said lengthwise body is circular in cross-section.
5. The sensor of claim 1, wherein at least one of said plurality of annular nubs is displaced longitudinally from said electrochemically active surface.
6. The sensor of claim 1, wherein said membrane system includes multiple membranes.
7. The sensor of claim 1, wherein said membrane system includes an enzyme layer.
8. The sensor of claim 1, wherein said electrochemically active surface extends through at least two of said plurality of annular nubs.
9. The sensor of claim 1, wherein said membrane system defines a catenary curve-shaped surface between at least two of said plurality of annular nubs.
10. The sensor of claim 1, wherein said membrane has an outer surface and said outer surface defines a concave curve curving toward said electrochemically active surface between at least two of said plurality of annular nubs.
11. The sensor of claim 1, wherein said membrane system defines an external surface of said sensor.
12. The sensor of claim 1, wherein said electrochemically active surface comprises platinum.
13. The sensor of claim 1, wherein said plurality of annular nubs comprises polyimide.
14. The sensor of claim 7, wherein said membrane system further comprises a permselective layer.
15. The sensor of claim 7, wherein said membrane system further comprises an interferent excluding layer.
CA2535394A 2003-08-14 2004-08-11 Method of constructing a biosensor Expired - Fee Related CA2535394C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/640,980 2003-08-14
US10/640,980 US7529574B2 (en) 2003-08-14 2003-08-14 Method of constructing a biosensor
PCT/US2004/025957 WO2005018420A2 (en) 2003-08-14 2004-08-11 Method of constructing a biosensor

Publications (2)

Publication Number Publication Date
CA2535394A1 CA2535394A1 (en) 2005-03-03
CA2535394C true CA2535394C (en) 2014-03-25

Family

ID=34136237

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2535394A Expired - Fee Related CA2535394C (en) 2003-08-14 2004-08-11 Method of constructing a biosensor

Country Status (6)

Country Link
US (1) US7529574B2 (en)
EP (2) EP1659933A4 (en)
JP (1) JP4790612B2 (en)
CN (1) CN100479739C (en)
CA (1) CA2535394C (en)
WO (1) WO2005018420A2 (en)

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Also Published As

Publication number Publication date
EP1659933A4 (en) 2009-03-11
EP1659933A2 (en) 2006-05-31
CN100479739C (en) 2009-04-22
WO2005018420A2 (en) 2005-03-03
US20050038330A1 (en) 2005-02-17
JP2007502162A (en) 2007-02-08
WO2005018420A3 (en) 2005-08-04
US7529574B2 (en) 2009-05-05
CA2535394A1 (en) 2005-03-03
CN1856270A (en) 2006-11-01
EP2564768A1 (en) 2013-03-06
JP4790612B2 (en) 2011-10-12

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