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US20040096959A1 - Analyte measurement - Google Patents

Analyte measurement Download PDF

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Publication number
US20040096959A1
US20040096959A1 US10/432,827 US43282703A US2004096959A1 US 20040096959 A1 US20040096959 A1 US 20040096959A1 US 43282703 A US43282703 A US 43282703A US 2004096959 A1 US2004096959 A1 US 2004096959A1
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Prior art keywords
fluid
channel
analyte
skin
measuring
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Abandoned
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US10/432,827
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English (en)
Inventor
Matthias Stiene
Tanja Richter
John Allen
Jerome McAleer
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Cilag GmbH International
LifeScan Scotland Ltd
Lifescan IP Holdings LLC
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Individual
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Assigned to INVERNESS MEDICAL LIMITED reassignment INVERNESS MEDICAL LIMITED ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MCALEER, JERRY, RICHTER, TANJA, STIENE, MATTHIAS, ALLEN, JOHN
Publication of US20040096959A1 publication Critical patent/US20040096959A1/en
Assigned to LIFESCAN IP HOLDINGS, LLC reassignment LIFESCAN IP HOLDINGS, LLC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CILAG GMBH INTERNATIONAL
Assigned to CILAG GMBH INTERNATIONAL reassignment CILAG GMBH INTERNATIONAL ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: LIFESCAN SCOTLAND LTD.
Assigned to CILAG GMBH INTERNATIONAL reassignment CILAG GMBH INTERNATIONAL CORRECTIVE ASSIGNMENT TO CORRECT THE DELETING PROPERTY NUMBER 6990849, 7169116, 7351770, 7462265,7468125, 7572356, 8093903, 8486245, 8066866 AND ADD 10431140 PREVIOUSLY RECORDED AT REEL: 050839 FRAME: 0634. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Assignors: LIFESCAN SCOTLAND LTD.
Abandoned legal-status Critical Current

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    • 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
    • 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
    • A61B5/1468—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
    • A61B5/1473—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 invasive, e.g. introduced into the body by a catheter
    • 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
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150213—Venting means
    • 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
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • A61B5/150419—Pointed piercing elements, e.g. needles, lancets for piercing the skin comprising means for capillary action
    • 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
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150442—Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
    • A61B5/15045—Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin comprising means for capillary action
    • 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
    • A61B5/150755—Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
    • 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
    • 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
    • A61B2010/008—Interstitial fluid

Definitions

  • This invention relates to apparatus for and methods of measuring certain properties of a fluid particularly although not exclusively, bodily fluids and the concentrations of certain analytes therein. At least some aspects of the invention relate particularly to the measurement of glucose levels in blood and other body fluids such as cutaneous (interstitial) and sub-cutaneous fluid.
  • test simplification allows the assay to be performed by relatively untrained personnel in a “non-laboratory” setting.
  • cardiac marker tests configured in a lateral flow immunoassay format with labelled antibody allow for early assessment of potential myocardial infarct.
  • the invention provides a device for measuring the concentration of an analyte in a fluid, comprising a support member, analyte sensing means provided thereon for measuring said concentration and a microchannel in fluid communication with said analyte sensing means for conveying said fluid to said sensing means.
  • a microchannel is used to convey the sample fluid to the sensing means.
  • microchannel refers to a channel, of any suitable cross-section, whose lateral dimension is between approximately 10-500 ⁇ m.
  • microchannels are beneficial for a number of reasons in the context of an analyte sensing device.
  • a small sample volume is beneficial since it means that it is easier to provide a sufficient volume for a valid test.
  • the volume of fluid required to carry out an assay is correspondingly small, in addition the microchannel allows to handle flow rates between 10 and 500 nL/min with a high resolution of the measurement over time, due to the low channel volume.
  • the analyte sensing means can be arranged in any suitable configuration depending on the type of sensing means used (electrochemical, optochemical etc.).
  • the analyte sensing means comprises one or more reagents to react with said analyte and thereby give a measurable output.
  • a reagent may be located anywhere, but preferably the reagent or at least one of the reagents is provided on a wall of the microchannel. This arrangement is beneficial since it means that no additional volume is required in order for the sample liquid to be brought fully into contact with the reagent—i.e. the contact area is optimised.
  • the invention provides a device for measuring the concentration of an analyte in a fluid, comprising a support member and a microchannel provided on said support member for conveying said fluid across the support member, wherein one or more reagents for reacting with said analyte is coated on a wall of the microchannel.
  • such a device further comprises means for sensing the analyte—for example an electrochemical or a photometric detector.
  • the devices set out hereinabove may be used for measuring any suitable analyte in any suitable fluid.
  • the invention finds particularly beneficial application in the measurement of analytes in human or animal bodily fluids.
  • a suitable sample of bodily fluid may be applied to the device.
  • the device is integrated with means for extracting the fluid.
  • this comprises means for penetrating the skin—in the case where the sample fluid is blood or interstitial fluid.
  • a skin penetration member such as hollow needle, solid lance or the like.
  • the device can be used both to collect the sample fluid and to measure the concentration of the target analyte—or at least give an output from which the concentration can be measured.
  • the present invention provides a device for measuring the concentration of an analyte in a fluid, comprising a support member, means provided on the support member for sensing said analyte, wherein said support member further comprises fluid extraction means arranged to direct fluid to said analyte sensing means via a conduit on the support member.
  • a fluid extraction means preferably a skin penetration means, most preferably a needle, lance or the like, is provided on a support member of a device for measuring analyte concentration.
  • skin penetration means e.g. needle
  • support member e.g. test strip
  • the preferred embodiments require a user merely to puncture their skin with a needle or the like and then blood or interstitial fluid may be conducted automatically onto or into the test member.
  • Devices for extracting interstitial fluid are shown in the afore-mentioned Integ patents and International patent application PCT/US01/09673 (International Publication WO 01/72220 published 4 Oct. 2001).
  • the combined needle/test member would normally be used in conjunction with a separate, non-disposable, measuring device for measuring the analyte concentration e.g. by means of the output of an analyte-reagent reaction, where appropriate.
  • the dimensions of the needle, lance or the like may be suited to the particular application.
  • any mechanism for extracting interstitial fluid may be used with the present invention. While the present invention will be described with reference to a shallow penetration needle, the invention is application to any technique for obtaining a body fluid.
  • a standard hypodermic needle several centimetres in length may be employed. Whilst the device may be used to sample interstitial fluid or blood from the cutaneous and/or the subcutaneous layers, in preferred embodiments however, the penetration member is of such a length that it penetrates substantially the cutaneous layer of skin.
  • substantially the cutaneous layer it means that whilst it is the intention to sample fluid from the cutaneous layer, it cannot be ruled out that some sampling from the sub-cutaneous may occur.
  • the cutaneous layer has a high density of blood capillaries which helps to ensure that the levels of analytes in interstitial fluid reliably reflect those in the blood.
  • the actual length of the penetration means will depend on the angle at which it is intended to be inserted.
  • the length may by of the order of several millimetres e.g. up to approximately 7 to 10 millimetres.
  • substantially perpendicular insertion is intended and the length is less than 2 mm, preferably less than 1.5 mm.
  • a length of approximately 1.4 mm is appropriate.
  • a length as short as 0.5 mm may be preferred
  • test member may have just one skin penetration member, or alternatively a plurality may be provided.
  • the penetration means may comprise a sufficiently short standard needle, possibly shortened if necessary. More preferably the penetration means comprises a microneedle.
  • a microneedle is hereby defined as a needle with a length sufficient to penetrate the cutaneous layer of human skin without substantially penetrating the subcutaneous layer. Such a needle typically has length less than 2 mm, preferably between 0.4 and 1.6 mm.
  • the outer diameter is preferably less than 0.5 mm, most preferably between 0.1 and 0.3 mm.
  • the penetration means need not be integrated with the support member, but preferably is.
  • the comments above regarding this arrangement apply, with the additional benefit noted here that preferred embodiments of this arrangement can provide a compact disposable device which gives rise to substantially no pain, in use and obviates the need for a user to come into contact with or even see the bodily fluid concerned.
  • Preferred embodiments of the invention use a reagent-based measurement.
  • Many different reagent-based analyte measurements are available to those skilled in the art, allowing the principles of the invention to find wide application.
  • an optochemical i.e. either fluorescent or luminescent—or an electrochemical technique could be used.
  • One preferred embodiment comprises analyte sensing means comprising a mediated amperometric enzyme electrode.
  • a ferrocene-mediated electron transfer from a glucose-oxidase catalysed reaction is a suitable means for detecting the level of glucose in a body fluid.
  • Other enzymes such as lactate oxidase or lactate dehydrogenase and cholesterol oxidase dehydrogenase may be used to measure lactate and cholesterol levels respectively.
  • use of the above electron-transfer mediator is a non-limiting example and that other electron transfer mediators well known in the art could be used, for example, hexa-cyanoferrate (ferricyanide), oxygen or components of the respiratory chain (i.e. cytochromes).
  • the embodiment will comprise an analyte sensing means which operates in conjunction with a test meter to give the measurement.
  • the member may comprise the appropriate reagent or dye for performing a calorimetric test in association with light sensitive means in the test meter. It will be seen that such arrangements are consistent with the test device being disposable since the costly elements of the sensing mechanism, such as the light sensitive means, electronic circuity etc., can be placed in a non-disposable test meter.
  • a plurality of conduits direct fluid to be measured to respective analyte sensing means.
  • the sensing means may be different so as to measure or test for different analytes in the fluid. Preferably however they are the same or at least are for measuring the same analyte.
  • the invention provides a device for measuring the concentration of an analyte in a fluid, comprising a support member and a plurality of analyte sensing means provided thereon for measuring said concentration, wherein said device further comprises a plurality of conduits such that each of said sensing means has a conduit associated therewith, said conduits serving in use to direct said fluid to respective sensing means.
  • the device whether it comprises a single or a plurality of conduit/analyte sensors, may be used to continuously measure the concentration of the analyte over a period of time. Periodic measurements may be taken i.e. the fluid is “sampled” at various periods over time, for example every 30 minutes.
  • Fluid may continuously flow through the device or may be temporarily stopped by, for example, hydrophobic gates.
  • the sensors may be of the single measurement type, after which the device is discarded or fluid is diverted to another conduit to perform another measurement.
  • the total time taken to complete a measurement cycle or the time taken between measurements could vary and would depend upon the degree of monitoring or the analyte of interest.
  • the plurality of conduits would allow for switching from sensor to another after a particular period of time, by diverting fluid flow from one conduit to another. Switching enables measurements to be performed without interruption to the fluid extraction or without having to recalibrate the sensors, which are known to drift after a period of time due to factors such as electrode fouling etc.
  • analyte monitoring may be made on a truly continuous basis, without the user having to recalibrate or interact with the system.
  • An advantage of performing a single measurement either in the case of a device with a single or plurality of microchannels is that drifting of the signal over time is no longer an issue that has to be considered and consequently simpler reagent chemistries may be employed in the analyte sensors. For example in the case of an electrochemical detection system, results may be obtained in as little as five seconds or less. Furthermore, such devices would not require storage reservoirs for collection of the waste fluid, since the waste fluid would be stored in the microchannel conduits themselves.
  • the sensing means may be electrochemical or non-electrochemical in nature—e.g. of the fluorescent or chemi-luminescent calorimetric sort.
  • the sensing means may comprises an enzyme-coated electrode in the case of electrochemical measurement, or in the case of fluorescent colorimetric sensing the sensing means would comprise a suitable reagent dye.
  • the term ‘sensing means’ does not necessarily refer to a complete assembly for giving a final reading, but rather to a means on the support member which yields an output which may be read to give a measure of the analyte concentration, e.g. by a separate test meter.
  • Such devices according to embodiments of the invention as set out above could be arranged to be used in a mode similar to conventional test strips i.e. where a single fluid sample is placed on the device and is measured.
  • devices of the sort set out above may be arranged to measure the concentration of any suitable analyte.
  • the analyte's concentration may simply be an indirect indication of the property of the sample fluid which it is desired to monitor.
  • a detection reagent e.g. an enzyme substrate or an antigen
  • the added detection reagent or the product of the enzyme-catalysed reaction comprises the analyte.
  • Devices in accordance with the invention can therefore be arranged to measure such analytes—i.e. it will be seen that such devices may be used to measure the activity of enzymes in a body fluid sample, or test whether antibodies to a particular antigen are present in the body fluid.
  • the device is arranged to measure an analyte concentration directly—i.e. it is the concentration itself which is being monitored.
  • concentration itself which is being monitored.
  • An example of such a measurement would be glucose in blood, the concentration of which is an important parameter for those suffering from diabetes.
  • the measuring device is suitable for measuring the concentration of an analyte, e.g. glucose, in blood or interstitial fluid.
  • the device is preferably suitable for attachment to the skin of the subject who is to be measured.
  • the subject may be an animal but,is preferably human.
  • measurements of the concentration of the substance in the subject's blood or interstitial fluid can be carried out repeatedly over a period of time.
  • the devices comprise a penetration member with a sufficiently length substantially to penetrate the cutaneous layer of skin, most preferably integrally formed with the support member. It is further preferred that such devices comprises at least one microchannel for conveying the interstitial fluid to one or more of the sensing means.
  • the present invention provides a device for measuring the concentration of a given analyte in a bodily fluid comprising means for attaching the device to the skin of a subject and a plurality of sensing means for making a plurality of measurements of said concentration over a period of time.
  • this aspect of the invention provides a device which can perform a plurality of measurements in situ, that is without user intervention being required. This has clear benefits in removing some constraints on the number, frequency and regularity with which measurements can be performed.
  • Each sensing element in the device is designed to be used for a certain predetermined time during which the signal will not significantly drift over time. In this sense “significantly” represents the amount of drift permitted such the measurement result would not be affected by an clinically unacceptable amount.
  • fluid is then switched to a new sensor and the process repeated.
  • the device is provided with flow control means for influencing the flow of fluid to the sensing means. Any suitable flow control method may be employed with corresponding means to affect such a control method. For example Piezo-electric pumping, electrokinetic or mechanical methods such as ‘unblocking’ the flow along a selected conduit.—e.g. by allowing a gas bubble to escape or by opening a valve.
  • the flow control means comprises a hydrophobic gate situated within the conduit/microchannel.
  • a hydrophobic gate as herein disclosed refers to a hydrophobic surface region within a hydrophilic channel such that the flow of fluid is interrupted. By changing the hydrophobic nature of the gate, i.e. by making the hydrophobic region more hydrophilic, fluid may then be allowed to flow along the channel. Hydrophobic gates may be used to control the flow of fluid within a single microchannel or may be used to switch or redirect flow from one microchannel to another.
  • the hydrophobic nature of the gate may be maintained as it is and a increased pumping force (e.g. provided by a mechanical or electro-osmotic pump) may be applied in order for the fluid to breach the hydrophobic gate.
  • a pumping force e.g. provided by a mechanical or electro-osmotic pump
  • the device is arranged to direct fluid sequentially to each of the sensing means.
  • the timing of the direction of the fluid to the sensing means could be pre-configured for example by software within the meter, such that the fluid is switched after a predetermined period of time.
  • the device comprises, or is adapted to interface with, control means to control said direction of the fluid to the sensing means. Such control is preferably automatic.
  • control means may be such as to allow a user to specify when a measurement is to be made. This is beneficial as it allows measurement on demand which is useful for example in the case of blood glucose monitoring, as it allows the user to determine the effect on blood glucose of eating a particular snack or to determine how much insulin it is necessary to inject prior to eating or the user may simply want to carry out a check for reassurance. This enables the device to make periodic measurements of fluid from the body of the subject using fresh fluid for each measurement, thereby facilitating the desired object of monitoring the concentration of the substance in question over a period of time.
  • each microchannel or other conduit is associated with a respective flow control means, each may be individually addressable by a suitable control means. This gives significant flexibility in how such a device may be used.
  • the device comprises a common fluid collection region in fluid communication with the bodily fluid to be measured—e.g. via a needle—each sensing means preferably being in selective fluid communication with said common collection region.
  • each sensing means preferably being in selective fluid communication with said common collection region.
  • any suitable conduit may be provided for conveying the fluid to be measured to the sensing means, but preferred arrangements comprise microchannels as defined herein.
  • the provision of microchannels allows many test elements to be positioned in close proximity thereby enabling even devices comprising a large number of sensing means to be made relatively small. This is beneficial in applications where the size and weight of the device is an important consideration, such as when it is attached to the user's body.
  • a very low sample volume means that rather than conduct the usual reaction rate measurement as in known electrochemical devices e.g. for detecting blood analytes such as glucose, where electron transfer is measured as a function of time to determine the rate of transfer, an end-point test can be carried out in which the total amount of analyte in the sample volume is measured, thereby consuming substantially all of the analyte.
  • the present invention provides a method of measuring the amount of an analyte in a sample of liquid comprising providing an electrochemical measuring device having a sensor electrode within a microchannel, introducing said sample liquid into said microchannel, and measuring an aggregate current passed by said electrode to give an indication of said amount of analyte in the sample.
  • This aspect of the invention also extends to an electrochemical device for measuring the amount of an analyte in a sample of liquid comprising a sensor electrode dispos d within a microchannel and means for measuring an aggregate current passed by said electrode in use to give an indication of said amount of analyte in the sample.
  • the invention also extends to an equivalent arrangement using a non-electrochemical sensing means—e.g. a calorimetric one.
  • a non-electrochemical sensing means e.g. a calorimetric one.
  • any suitable transfer means for transferring the fluid from the user's body to the device may be employed.
  • methods such as suction, ultra-sound or iontophoresis may be used.
  • the transfer means comprises a needle.
  • the needle is a microneedle as defined hereinabove.
  • the needle is preferably shaped to aid skin penetration.
  • the tip region of the needle is preferably substantially conical.
  • the tip region has a reduced cross-section—preferably less than 0.2 mm in width, most preferably less than 0.05 mm in width.
  • the needle is preferably arranged to minimise the risk of blockage upon insertion into skin.
  • the aperture of the needle may be provided on a side surface of the needle, rather than at the tip as is conventional.
  • the aperture of the needle is recessed, thereby avoiding contact with the skin upon penetration and thus potential blocking and/or damage
  • the needle preferably has a bore such that the sample fluid is drawn up by capillary action.
  • Suitable needle bore sizes range preferably from 21-30 most preferably 25. Any suitable inert and biocompatible material for the needle may be employed.
  • inert materials include but are not limited to stainless steel, gold, platinum and metal-coated plastics
  • microneedles is employed as defined hereinabove.
  • the methods above may be supplemented by applying pressure to the user's skin around the site at which it is penetrated.
  • pressure could be applied purely manually, but preferably the device comprises means—e.g. suitably configured resilient means—to apply the pressure.
  • the device may have skin pressurising means as explained in more detail below and as shown in the figures. Examples of skin pressurising means are set out in copending application US09/877,514 filed Jun. 8, 2001.
  • the devices of the preferred embodiments comprise display means to display the concentration of the analyte being measured such as blood glucose.
  • display means may be coupled directly to the measuring device, but preferably it is separate from the device and receives data therefrom by telemetry.
  • This approach has the advantage that the measuring device can be very light and thus comfortable to wear.
  • the measuring device may be worn under clothing but monitored on a display means kept, say, in a pocket or for example in the form of a watch worn on the arm of the user, without the user having to disturb their clothing in order to view it.
  • the device comprises or is coupled to means for administering a substance to a user on the device on the basis of the measured concentration.
  • a substance to a user on the device on the basis of the measured concentration.
  • the insulin pump could be a separate device or alternatively could be integrated within the analyte sensing device per se. Controlling means present for example within the meter could control the amount of insulin administered by the insulin pump in response to the level of glucose measured by the device.
  • preferred embodiments of this inventive feature can allow a diabetic, to maintain control of his/her glucose levels with a minimum of intervention i.e. only to replace consumable items such as a sensor/insulin patch.
  • the present invention provides an apparatus for administering a substance to a user comprising a measuring device for measuring the concentration of an analyte in a bodily fluid from said user, said measuring device comprising a plurality of analyte sensing means and at least one conduit, preferably a microchannel, for conveying said bodily fluid to at least one of the sensing means; the apparatus further comprising means to administer said substance to said user on the basis of said measurement of concentration.
  • the measuring device preferably comprises a means for attachment to the skin of a user, for example in the form of a self-adhesive patch. This can provide a secure but comfortable arrangement for use over prolonged periods of time, and can be relatively unobtrusive.
  • the means for administering the substance may be entirely separate from the measuring device or integrated therewith.
  • an integrated administering means comprises a reservoir on or in the measuring device for dispensing the substance.
  • the substance, such as insulin is contained within a reservoir on an adhesive patch.
  • the actual means for getting the substance from such a reservoir could comprises anything suitable such as a pressurised supply in conjunction with a flow control means such as a valve.
  • a pump is used.
  • a single pump may be used both to administer the substance, such as insulin, to a user's body and also to draw out blood or preferably interstitial fluid, to a sensing means for making an analyte concentration measurement e.g. of glucose.
  • a suitable device may comprise an adhesive patch comprising a microneedle (as defined herein) coupled to or in fluid communication with an array of microchannels and a separate needle for injecting insulin.
  • a single pump e.g. a silicon micro-pump, may be used to inject insulin from a reservoir on the patch and to draw interstitial fluid over a glucose sensing means to a waste reservoir.
  • control and/or data processing means these will generally comprise electronic means such as an integrated circuit or the like.
  • a power supply is then also required.
  • control/processing means are portable. It or they may be provided in an integral package with the device e.g. the adhesive patch. Alternatively the control/processing means and/or power source may be provided separately and communicate with measuring device via a wire or wireless telemetry link as mentioned above.
  • the power source may be a battery or may be a ‘renewable’ source such as a solar cell or a dynamo energised by movement of the user. Of course a combination of these could be employed.
  • Measuring devices in accordance with the present invention may be fabricated using any suitable technique.
  • the microchannels may be made using any suitable micro-fabrication technique such as but not limited to embossing, plasma etching or injection moulding
  • electrodes are provided on opposing sides of a fluid channel by forming a first channel which is filled with a conductive material, and forming a second channel for conveying the test fluid, the second channel cutting across the first thereby thereby forming two conductive portions within respective opposite sides of the second channel.
  • the conductive portions formed in accordance with the invention could be utilised for an electrochemical sensor arrangement.
  • Micromachining techniques for making the abovementioned intersecting channels are preferred since they can be used to fabricate microchannels which can be formed close to one another, permitting dense arrays thereof.
  • the driving electrodes are preferably positioned in close proximity to one another. This allows high electric fields to be achieved without applying unnecessarily high voltages.
  • driving electrodes are provided substantially on one side of a channel. In one embodiment the driving electrodes extend around the wall of the channel.
  • one or more electrodes may be formed on a second substrate which is then laminated to the main support member of the device.
  • Methods used to deposit the electrodes onto the second substrate may be chosen preferably from a printing method, more preferably a screen-printing method.
  • chemical or physical vapour deposition techniques could be employed.
  • the electrodes according to all embodiments of the invention may be formed of any suitable inert material such as carbon, gold, platinum, etc.
  • carbon electrodes optionally coated with reagents are provided on the second substrate by screen-printing, which is then laminated onto the support member thus closing the channel or channels and two gold electrodes are provided adjacent one another on a substrate laminated onto the support member for an electro-osmotic pump.
  • a second substrate is provided, preferably it is arranged to close the channel provided on the support member. This allows a very straightforward fabrication method in which electrodes are formed within a closed channel.
  • Lamination of one substrate to another will normally be carried out such that both laminates are perfectly aligned and that no further trimming or cutting is necessary.
  • the device could be fabricated for example by firstly a lamination step followed by a cutting step whereby the second substrate may be trimmed to the shape of the support member.
  • Lamination may be carried out by various methods such as ultrasonic or thermal welding or bonding, or by the use of an adhesive.
  • the support member is formed with an integral needle at one end and the second substrate is then laminated onto the support forming a channel and leaving the penetration member exposed.
  • the integrated skin penetration member is provided is open on one side. The penetration member is arranged so that upon insertion into skin, the skin itself effectively forms a wall of the member to that it can act like a hollow needle. Most preferably this is achieved by forming the penetration member with walls tapering away from the open side—e.g. a V shape.
  • the invention provides an apparatus for obtaining and measuring fluid , comprising a skin penetration member having at least one longitudinal side open, the other sides being arranged so as effectively to cause the penetrated skin to act as the remaining longitudinal side of the member when the penetration member is inserted into the skin.
  • the present invention provides a method of fabricating a device for measuring the concentration of an analyte in a fluid comprising providing a support member, forming an open channel on a surface of the support member and laminating a second layer onto said support member so as to close said channel.
  • the invention also extends to a device fabricated using such a method.
  • a light sensing means will, in general, be required.
  • a light source may also be required, but is not always the case, for example in the case of chemiluminescent measurement.
  • Any such light sensing means and/or the light source may be provided integrally with the non-disposable measuring device e.g. a test-meter. According to one embodiment it or they are provided separately of the part of the device which is brought into contact with the sample fluid—e.g. a skin patch. This means that the device itself can be made disposable while the relatively more expensive light sensing means and associated electronics for example could be provided in a separate test meter.
  • the test device comprises means for optimising the light transfer from the sensing means to the optically sensitive means.
  • such means comprises a lens, e.g. integrally moulded as part of the support member for the test device.
  • the device may be arranged such that the light sensitive means views the sensing means along the conduit, e.g. microchannel, along which the sample fluid passes.
  • the conduit preferably a microchannel, acts as a light pipe.
  • the path length and therefore the optical density may be increased for a minimal sample volume. , thereby making its measurement easier and more accurate.
  • the material from which the conduit is formed is preferably chosen so to maximise light throughput at the frequencies of interest.
  • the arrangement described above is beneficial in its own right in enhancing the signal that may be measured from a minimal sample volume and thus when viewed from a yet further aspect the present invention provides an apparatus for measuring the light from an assay comprising an elongate conduit portion along which a sample fluid is drawn in use and a light sensitive means arranged to be sensitive to light coming substantially from the longitudinal axis of said conduit portion.
  • a disposable skin patch is provided with a moulded plastics lens over the analyte sensing means.
  • a corresponding test meter is designed to be placed over the patch and comprises a light sensitive element which sits over the lens when the meter is placed over the patch.
  • FIG. 1 shows a first embodiment of the invention, in the form of a skin patch, in cross section;
  • FIG. 2 a shows an alternative microchannel arrangement
  • FIG. 2 b shows a multiple channel/sensor arrangement
  • FIG. 3 depicts a cross section view of the skin patch of FIGS. 1 , and 2 attached to the skin of the user with a controller unit attached to the skin patch;
  • FIG. 4 depicts a display unit
  • FIG. 5 depicts another embodiment of the invention, showing schematically a skin patch integrated with a needle, which also acts as an electrode, in cross section;
  • FIG. 6 a depicts a microchannel and optochemical sensor in plan view
  • FIG. 6 b depicts a microchannel and electrochemical sensor in plan view
  • FIGS. 6 c to e are cross sections of the microchannel of FIG. 6 b with fluid progressively entering the channel;
  • FIG. 8 a shows a further embodiment of the invention, in the form of a single-use device with an integrated puncturing means
  • FIG. 8 b is a cross section through a user's skin having the device of FIG. 8 a therein;
  • FIGS. 8 c and 8 d depict the construction of a device similar to that in FIG. 8 a;
  • FIG. 8 e is an alternative embodiment, shown in perspective view, of a puncturing means
  • FIG. 8 f is a still further embodiment of an alternative puncturing means shown in perspective view
  • FIG. 8 g is a side-sectional view of the embodiment of FIG. 8 f taken along line X-X in FIG. 8 f;
  • FIG. 8 h is a cross-sectional view of the lance of FIG. 8 e in tissue
  • FIG. 8 i shows an integrally formed base member and lance showing a vent and a capillary sensing channel, but with upper laminate removed for clarity;
  • FIG. 12 a is a perspective view of a microchannel
  • FIG. 12 b is a close-up, partial, perspective view of a microchannel; whereby electrodes are provided on opposing sides of a fluid channel by forming a first channel which is filled with a conductive material, and forming a second channel for conveying the test fluid, the second channel cutting across the first thereby thereby forming two conductive portions within respective opposite sides of the second channel.
  • FIG. 17 a is top view, taken in perspective, of a first preferred embodiment of a chip for extracting and distributing a fluid sample and having a meander shaped waste reservoir;
  • FIG. 17 b is the view of the embodiment of FIG. 17 a modified to illustrate a column shaped waste reservoir
  • FIG. 18 is a bottom view, taken in perspective, of the chip of FIG. 17 a;
  • FIG. 19 is a plan view of a measurement channel of the chip of FIG. 17 a;
  • FIG. 20 a is a plan view of the meander shaped waste reservoir of the embodiment of FIG. 17 a;
  • FIG. 20 b is a plan view of the column shaped waste reservoir of the embodiment of FIG. 17 b ;
  • FIG. 21 is a plan view of the switching mechanism shown in FIG. 20 a.
  • FIG. 1 there is shown a skin patch 2 suitable for measuring the level of blood glucose in a user.
  • Patch 2 is made up of two layers 3 a and 3 b
  • the lowermost layer 3 a is made of an suitable microfabricated plastic such as polyester, polycarbonate, polystyrene, polyimide, or other suitable microfabricatable polymers of suitable dimensions to allow it to be worn comfortably for a prolonged period of time, and optionally has an adhesive on its underside to allow the patch to be securely attached to the skin of a user.
  • An optional pressure ring ( 5 ) is designed to apply pressure to the surface of the skin to enhance the flow of fluid from the body of the patient into the device.
  • the pressure means may also be integrally formed and of the same material as that of 3 a .
  • the drawing is not to scale and thus the various features may be of a different relative thickness dimension than illustrated. It is understood that FIG.
  • a penetration device ( 4 ) e.g. a needle, lancet or cannula is attached to the lowermost layer 3 a , through which fluid passes into the collection and fluid collection and distribution port ( 7 ) formed in the upper surface of layer 3 a .
  • Layer 3 a has on its upper surface microfabricated channels.
  • Port ( 7 ) is also formed by the same microfabrication process as the microchannels.
  • a substrate layer 3 b Laminated to the lowermost layer is a substrate layer 3 b , preferably formed of the same material as that of the lowermost layer. This serves to close the microchannel.
  • the microchannel and penetration member may optionally be coated with a hydrophilic material and/or an anti-coagulant such as a heparin attached to the inner surface such that during use it will not diffuse away.
  • the microchannel system 8 corresponding electrochemical detectors 11 and optionally the electro-osmotic pump systems 10 and the hydrophobic gates 12
  • Each of the electrochemical detectors 12 and electro-osmotic pump systems 10 are electrically connected via conductive tracks (not shown) to respective terminals (not shown) at the edge of the patch. Not shown in FIG. 1 are the fluid reservoirs.
  • FIG. 2 a shows another embodiment whereby hydrophobic gates are present on either side of the sensor.
  • a controller unit 102 is brought into contact with these terminals so as to make electrical contact in use in order to transmit the measurement output signals between the patch and a display unit 103 (see FIGS. 3 and 4).
  • a control unit 102 for the patch 2 is shown in FIG. 3. As may be seen, this sits on top of the patch 2 and is secured to upper side of the patch in a suitable manner(not shown).
  • the control unit serves to control the fluid pumping mechanism, hydrophobic gates, fluid switching means and analyte sensors.
  • the control unit is also provided with means such that radio frequency communication may be made, for example with the meter, for transmission and receipt of data.
  • the control unit would also determine when all the microchannel/sensors had been used and transmit a signal accordingly.
  • the control unit would also have means to detect any malfunctioning of the device and to also transmit this information.
  • the control unit 102 is preferably battery operated and is capable of transmitting signals to a wireless display unit (FIG. 4) for example a radio frequency communication.
  • a wireless display unit for example a radio frequency communication.
  • FIG. 2 b shows a multichannel arrangement with the proximal end of the needle 4 is in fluid communication with a fluid collection and distribution port ( 7 ) formed in the substrate layer 3 b of the patch. Radiating out from the manifold 6 are eighteen of the microchannel systems 8 . Not shown is the fluid switching means.
  • microchannel system 8 is shown in greater detail in FIG. 6 b .
  • the microchannel 608 is in direct communication with the port 607 into which the fluid flows from the needle 4 .
  • Downstream of the port 607 is an electrode system comprising a pair of inert electrodes 610 providing electrosmotic flow.
  • the electrodes are formed on a second substrate layer 3 b (omitted from this figure for clarity).
  • the second substrate layer is then laminated onto the first substrate layer 3 b thereby closing the microchannel 126 and bringing the electrodes 610 into contact with it.
  • the electrodes 610 are positioned adjacent to each other, together forming an electro-osmotic pump system. By applying a voltage difference across the electrodes, an electric field is generated which drives fluid along the microchannel 608 .
  • hydrophobic gates 612 Positioned along the microchannel 608 is one or more hydrophobic gates 612 which prevents the flow of fluid by capillary action along the microchannel. Downstream of the hydrophobic gate 128 is an electrochemical sensor 611 comprising at least two electrodes also formed on the upper substrate layer 3 b . At least one further hydrophobic gate similar to the first, is optionally provided downstream of the sensor 12 . This serves to stop the flow of fluid past the electrodes to allow the possibility for an end-point detection of the analyte.
  • hydrophobic gates may be constructed of any suitable material, including, but not limited to, PTFE, polycarbonate, polyisobutelene, PMMA, dodecyl acetate, silicon rubber, synthetic way, octadocyl mercaptane, dodecyl mercaptane, and/or octa decyltrichloro silane.
  • the controller unit 102 is provided with control means or means to initiate the flow of interstitial fluid sequentially to each of the microchannels ( 8 ) after a predetermined period of time. Once all the tests on the patch 2 have been performed, the controller 102 transmits a signal to the display means 103 to alert the user so that the patch 2 can be discarded and a fresh one applied.
  • FIG. 6 a An alternative form of microchannel 126 is shown in FIG. 6 a .
  • the optical sensor comprises a reaction chamber 616 which for example contains Glucose oxidase (GOD) Horseradish Peroxidase (POD) and a leuco-dye, (a colourless precursor of the dye molecule).
  • GOD Glucose oxidase
  • POD Horseradish Peroxidase
  • leuco-dye a colourless precursor of the dye molecule.
  • 2,2-Azino-di-[3-ethylbenzthiazoline-sulfonate The optical system is not limited to the above example and could comprise any suitable enzyme-dye combinations.
  • the reaction which takes place is as below:
  • the chamber 129 has an optically transparent upper surface. This arranged is to be aligned with the tip of an optical fibre in a modified control unit (not shown) so that the fibre is approximately 2 to 3 mm above the dye spot. The other end of the fibre is in optical contact with a light source and light sensitive diode sensor which is sensitive to a particular wavelength of light (for example 438 nm in the case of ABTS) emitted by the transformed dye. The degree of absorption therefore gives a measure of the amount of transformed dye and thus the amount of glucose present.
  • a light source and light sensitive diode sensor which is sensitive to a particular wavelength of light (for example 438 nm in the case of ABTS) emitted by the transformed dye.
  • glucose present in the fluid acts as a substrate for GOD, which breaks the glucose down into glucono-1,5-lactone and hydrogen peroxide. POD subsequently catalyses the oxidation of the leuco-dye using the hydrogen peroxide, resulting in the production of a coloured dye which is subsequently detected.
  • any suitable leuco-dye may be used, e.g. Tetramethylbenzidine-Hydrochloride, or 3-Methyl-2-Benzothiazoline-Hydrazone in conjunction with 3-Dimethylamino-Benzoicacide.
  • microchannels described as hereinbefore use electrochemical or colorimetric means to detect glucose.
  • detection means such as infra red detection, filter photometry or Kromoscopy may be used.
  • FIG. 5 shows schematically a further preferred embodiment of the invention. Similar construction to that of the previous embodiments and thus it has a hollow needle 106 , for example but not limited to 1.4 mm long and 0.3 mm wide which penetrates substantially the cutaneous layer of the skin 113 of the user.
  • the needle 106 also acts as an electrode which serves to extract fluid from the skin. At least one electrode 108 is provided such it makes contact with the skin. As shown in FIG. 5, the needle is poised at a positive potential. By applying a voltage difference across the electrodes 106 and 108 an electric field is generated along the needle 106 and manifold 111 which stimulates the skin and increases the perfusion of interstitial fluid out of the skin.
  • FIGS. 8 a to 8 d show two further embodiments of the invention.
  • these are both single-use strips suitable for measuring blood glucose of a user. They are therefore used in a similar way to conventional test strips. However a principle difference is that each has an integrated lance 119 at one end.
  • the device 115 shown in FIG. 8 a is made essentially of a layer 116 onto which a second layer is attached or laminated (not shown).
  • the lowermost substrate layer 116 comprises a moulded or stamped microchannel 118 , as well as the integrally formed lance 119 arranged in close proximity with the entrance 103 of the microchannel.
  • the microchannel 118 maybe coated with suitable reagents, such as glucose oxidase in the case of glucose detection, which can be applied by any conventional means, such as printing for example screen-printing or ink-jet printing, or spray coating during manufacture.
  • the microchannel may be free of enzyme, the reagents being provided on the electrode system ( 121 ) located on the underside of the uppermost layer ( 117 ).
  • the uppermost layer 117 may also be a conventional biosensor test-strip which could be attached to the lower surface such that the electrodes are positioned on the underside of the formed channel.
  • This particular electrode system 121 comprises three electrodes 221 of which at least one is covered with layers of enzyme and electron mediator such as glucose oxidase and ferricyanide to form a working electrode for detecting glucose, as is well known in the art, the other two being a counter and reference electrode.
  • the electrode system may comprise two working electrodes which serve to compare currents at each and measure the channel filling speed of the blood or interstitial fluid. Alternatively the electrode system could comprise just two electrodes, a working and counter/reference. Not shown in FIGS.
  • 1 - 21 is a venting device such that air may be displaced upon uptake of fluid into the microchannel.
  • a vent or vents may be provided at any convenient location.
  • Corresponding tracks 321 allow electrical connection to be made to the electrodes at the distal end of the strip when it has been inserted into a suitable test meter.
  • the upper layer 117 may be slightly longer than the lower one 116 to allow access to the tracks 321 for this purpose.
  • the lance 119 of the strip 115 in FIG. 8 a is essentially V shaped in cross section and tapers towards its tip. This means that when it is used to puncture a user's skin 123 , as is shown in FIG. 8 b , the two sides of the V force back a portion of the skin 123 , forcing the epidermis to form the remaining wall 123 of an enclosed channel 124 .
  • an open channel is effectively transformed into a closed one when it is inserted into skin.
  • the microchannel 118 may also be formed with a V shaped profile for convenience of fabrication, but this is not essential as may be seen from the slightly modified embodiment of FIGS. 8 c and 8 d in which the microchannel 118 ′ has a rectangular profile.
  • the user pierces their skin with the lance 119 and interstitial fluid or blood is made to flow, by means of capillary action, through channel 124 formed by the lance ( 119 ) and the skin 122 , into the microchannel 118 and thus over the electrochemical detector 121 .
  • the user then withdraws the strip 115 and inserts the opposite end into a conventional style test meter which makes electrical connection to the three conductive tracks 321 .
  • the meter is an integral part of the lancing system such that the user does not need to insert the strip into the meter and is automatically provided with the measurement result.
  • FIGS. 8 e through 8 h show alternative embodiments of lances for penetrating into a body-fluid laden layer of skin as an alternative to the embodiment of the lance 119 of FIGS. 8 a and 8 b .
  • the lance 119 a is an integrally formed pointed protrusion from the device 115 (not shown in FIGS. 8 e but identical to that in Fog. 8 a ) with a longitudinal capillary channel 121 a cut completely through the thickness of the lance 119 a .
  • the lance 119 a is provided with an enlarged area 123 a of the channel 121 a .
  • the enlarged area 123 a also is cut completely through the thickness of the lance 119 a .
  • the capillary channel connects with the microchannel 118 of the device 115 of FIG. 8 a.
  • FIG. 8 h the embodiment of FIG. 8 e permits fluid to enter into the capillary channel 121 a from opposite sides of the lance 119 a and with the wall of the skin cooperating with the walls of the lance 119 a to define an enclosed channel 121 a . Fluid then can accumulate in the pooling area 123 a and flow from the pooling area 123 a into the capillary channel 121 a as well as flow directly from the skin into the capillary channel 121 a for passage to the microchannel 118 .
  • a lance 119 b is of a design similar to that of FIG. 8 e is shown but excluding the large pooling area 123 a . Elimination of the pooling area 123 a permits a narrower transverse dimension to the lance 119 b.
  • the base member 116 and lances 119 , 119 a , 119 b can be stamped from electrically conductive material.
  • the base member may be an electrode.
  • An electrically conductive base member and lance can be stamped from metal as described or formed in any other acceptable manner (e.g., photochemically etching a metal stock material, machining or other fabricating technique).
  • the electrically conductive base member can be made of stainless steel it can be also be plated with a second metal such as for example gold platinum or silver.
  • the electrically conductive base material may also be used as a counter electrode.
  • FIG. 8 i shows an integrally formed base member and lance stamped from preferably one piece of sheet metal.
  • the metal is preferably, but not limited to, stainless steel optionally coated with a noble metal such as gold or silver.
  • a microchannel 84 onto which a second layer such as a test-strip could be attached. It is intended that such a device as illustrated in FIG. 8 i would be incorporated into a lancet firing device such that the device could be fired into the skin.
  • the individual devices may be loaded and stored in a cassette comprising individually sealed pouches. Such a cassette could also be stored within the lancet firing device.
  • the stamped penetration member with a rectangular vent 81 which also serves as a capillary break ensuring that once fluid is taken up by the lance 83 into the sensing zone 82 , the flow of fluid is halted.
  • the vent may be of any suitable size or shape.
  • FIGS. 17 a - 21 the present invention will now be described with reference to a most preferred embodiment of the invention in an ex vivo continuous monitoring system.
  • the ex vivo continuous monitoring system consists of several major subsystems including sample extraction, sample fluid distribution, and electrochemical detection. As will be more fully described below, a body fluid sample can be extracted from the skin and guided into a channel for the electrochemical determination of glucose concentration.
  • the body fluid is directed into a different, previously unused channel. This process avoids false results otherwise arising from fouled electrodes or denaturant enzymes. Since the channels into which the fluid is re-directed are not filled with a sample solution or any other liquid, the electrochemical system in the channel will not show aging effects.
  • FIGS. 17 a , 17 b show embodiments of such a chip 400 , 400 a .
  • each chip 400 , 400 a has for example, but not limited to, twelve measurement channels 402 , 402 a with switching mechanism 404 and 404 a and waste reservoirs 406 , 406 a .
  • Differences in the embodiments of chips 400 , 400 a will be described below with initial description being limited to a discussion of chip 400 . It will be appreciated that chip 400 a is identical to chip 400 except as will be described. Similarly elements are numbered similarly with the addition of an “a” to distinguish embodiments.
  • the chip 400 has an edge connector 401 for electrically connecting electrodes (as will be described) to a controller (not shown).
  • a controller can contain logic, memory and processors for controlling the electronics of the chip 400 and optionally displaying any outputs (as, for example, the function and operation of controller 102 in FIG. 3).
  • the measurement results are transmitted by radio frequency by the controller to a remote control allowing the user to view the result and optionally to communicate or interact with the controller of the monitoring system.
  • the sampling chip 400 extracts body fluid from the skin.
  • the chip 400 extracts interstitial fluid (ISF) from substantially the cutaneous layer of a patient.
  • ISF interstitial fluid
  • the chip 400 includes a suitable cannula or needle 410 , a spring-loaded hub 412 to pressurize the skin and means such as an adhesive 414 to fix the chip 400 to the skin.
  • Sampling modules with needles and spring-loaded hubs are shown in U.S. Pat. Nos. 6,203,504 and 5,746,217. It will be appreciated the foregoing description is a preferred embodiment. Any technique for obtaining a sample of body fluid may be used in combination with the teachings of the present invention.
  • the needle 410 discharges the body fluid into a common distribution depression 416 shown best in FIG. 19).
  • the distribution depression 416 is in fluid flow with the micro-channels 402 .
  • the shape and the volume to the distribution depression 416 is preferably a disk shaped void with 1 mm diameter and 100 ⁇ m depth. These dimensions and shape may vary depending upon the size, number and flow rate of individual channels.
  • a portion of the micro-channel 402 between the distribution depression 416 and a ground or reference electrode 420 may be restricted in size to reduce flow rate variability and therefore control the rate of flow.
  • Means may be provided within the device for the removal of undesirable gas-bubbles from the fluid sample.
  • Such means could comprise a filter positioned between the needle and the common reservoir.
  • the electrochemical detection system consists of an electrode system shown best in FIG. 19.
  • the electrode system includes at least one working electrode 418 (by way of non-limiting example, gold or carbon) and a reference electrode 420 (e.g., silver/silver-chloride).
  • the reference electrode 420 is circular to serve as a common electrode for each channel 402 , thus reducing the number of contacts necessary.
  • each channel can be provided with a unique reference electrode.
  • Each channel 402 has a unique dedicated working electrode 418 .
  • a counter electrode (not shown) may be added.
  • the electrodes 418 , 420 are disposed to contact fluid in the channel 402 .
  • the channels 402 are formed as open channels in a substrate layer.
  • the electrodes 420 , 418 are screen-printed on an overlying laminate layer which also serves to seal the channels 402 .
  • the working electrode material is dependent on the enzyme ink being used. For example, one can distinguish between a redox-mediated system for the carbon working electrodes and an oxygen mediated system for the gold or platinum electrodes.
  • an organo-metal-complex (which is linked to polymers forming the ink body) acts as a conductor and electron acceptor for the enzyme.
  • the electrons are transported by the redox-mediator directly or by an electron hopping mechanism from redox-center to redox-center to the working electrode.
  • the mediator is finally recycled to its original redox-state before it can react with the enzyme protein in a new cycle.
  • glucose oxidase from aspergillus niger (GOD EC 1.1.3.4) and PQQ dependent glucose dehydrogenase (GDH EC 1.1.99.17).
  • the enzyme ink is a cross-linked hydrophilic gel allowing the penetration of sample fluid but restricting the movement of the enzyme thus it is fixed to the electrode. This is an important property of the enzyme ink because the concentration of the enzyme has an effect upon the total response of the sensor. The same effect can be observed with the redox-mediator, due to the small molecular weight it cannot be entrapped in the same way as enzymes. Therefore, in the preferred embodiment, it is preferred to link the redox-mediator molecule to the large molecules such as the enzymes, proteins, or to the polymers of the ink material directly. In case of oxygen-mediated systems the situation is simpler.
  • the enzyme ink needs only to contain enzyme as active component, the oxygen itself is dissolved in the sample fluid and is transferred to the sensor from the sample stream in the same instance as glucose.
  • the oxygen-mediated system can be created with GOD based on the ability of the enzyme to build hydrogen peroxide from oxygen and glucose.
  • Ox oxidized mediator species e.g. K 3 [Fe(CN) 6 ], p-benzoquinon, Ferrocinium
  • Red reduced mediator species e.g. K 4 [Fe(CN) 6 ], hydroquinone, Ferrocene
  • Hydrogen peroxide is a very reactive molecule, which can function as mediator to transport electrons for the enzyme to the electrode surface.
  • the electrodes are deposited on a film such as polystyrene or polycarbonate of about 10-200 ⁇ m and, more preferably, about 30 to 75 ⁇ m) using screen-printing technology. Subsequently to this print step the working electrode is coated with ink containing enzyme and in the case of carbon working electrodes with an ink containing enzyme and mediator.
  • a film such as polystyrene or polycarbonate of about 10-200 ⁇ m and, more preferably, about 30 to 75 ⁇ m
  • This coating step could be accomplished with the same printing methods as used for the electrode material. Thus the production could be done in one machine with different print heads or stations on a continuous web. Such a process is described in “Continuous Process for Manufacture of Disposable Electrochemical Sensor”, U.S. patent application Ser. No. 09/537599.
  • FIG. 19 A schematic diagram of one measurement channel 402 is shown in FIG. 19.
  • the channel 402 extents from the needle 410 and distribution depression 416 and through the main channel 402 (of dimensions for example of 200 ⁇ m ⁇ 100 ⁇ m) containing the electrodes 418 , 420 .
  • a flow restricted portion of the channel 402 namely a small cross section (e.g., 30 ⁇ m ⁇ 30 ⁇ m) may be provided between the distribution depression 416 and the common electrode 420 .
  • a flow restriction levels out different flow rates during the extraction of the body fluid. These flow rate differences are caused due to the changing physiological conditions during the extraction. In general, one could observe a higher flow rate at the beginning of a sampling period compared to the extraction rate at the end. A thin capillary can counter-act this behavior.
  • the electrodes 418 , 420 are not part of the injection molded base plate of the chip 400 . Instead, they are placed on top of the open U-shaped or rectangular channel 402 of the base plate of the chip 400 in a separate lamination step.
  • the waste reservoir 406 stores the sample solution after its evaluation by the electrochemical sensing in channel 402 .
  • the size of the waste reservoir 406 defines the amount of time one channel can theoretically be used.
  • the controller can activate the next channel to continue with the detection of glucose in the body fluid of a patient.
  • the reservoir 406 is large enough to support more then a two-hour measurement.
  • a chip 400 with twelve channels 402 can run for 24 to 28 hours allowing the patient a convenient change to a new chip (e.g. during his daily morning routines).
  • reservoirs 406 larger then 5 ⁇ L (which is enough to support the flow for more then two hours with a flow rate of 30 nL/min) could allow longer runtimes.
  • the entire chip 400 could last for more than one day.
  • the number of channels in a device is not limited and may vary depending upon the measurement technique, the length of monitoring period and the size of the device and could exceed 100 .
  • FIGS. 20 a , 20 b show two different representative embodiments of the waste reservoir 406 , 406 a .
  • Waste reservoir 406 is a meander-shaped extension of the channel 402 . While easy to manufacture, such a design can build up high back pressure in the system, due to the weaker capillary force, then the design of waste reservoir 406 a and is not as space efficient.
  • the column filled reservoir 406 a has advantages compared to the meander-shaped reservoir 406 regarding the size and the integration into a 12-channel chip 400 a . It could be deeper than the reservoir 406 while producing a higher capillary force to take up the extracted and evaluated sample fluid from channel 402 a .
  • waste channel 406 a resembles a plurality of capillaries with a cross-section for example of 400 ⁇ m ⁇ 400 ⁇ m compared to only one-capillary with the same cross-section in the design of waste reservoir 406 .
  • the shape of the columns is not limited to simple squares. They could be formed as circles, pentagons, hexagons, octagons or the like. Concerning the flow characteristics inside a column field the hexagon shaped columns shown are the most preferred version.
  • the size and geometry of the channels and reservoirs may vary.
  • the base plate of the chip 400 can be produced in a molding process, which is optimized for the small features and structures.
  • plastics can be used for the base plate of the chip 400 (e.g. polystyrene, polycarbonate, polymethymethacrylate, polyester, and others).
  • Preferred polymers are polycarbonates. These allow a subsequent laser finishing to generate a secondary micro- or nano-structure (e.g., any desired patterns or other finishing can be formed in the micro-channel).
  • Polystyrene shows preferable characteristics in the lamination process. Thus polycarbonate could be used as the lower laminate and polystyrene used as the upper.
  • the chip 400 itself consists of three major part a) the chip base plate with all the fluidic elements described above, b) the electrochemical detection system screen printed on a polymer foil, and c) the sampling hub with extraction needle. These elements are described in the foregoing sections.
  • the most advantageous process is an adhesive-free thermal bonding process of the pre-printed foil to the chip base plate.
  • the bonding happens at an elevated temperature with a stamping tool or a hot roller press.
  • the temperature is close to the glass transition temperature (T g ) of the polymer thus the low molecular weight portion of the polymer will become mobile and tacky while the high molecular weight portion of the polymer still supports the integrity of the foil or film.
  • T g glass transition temperature
  • the low molecular weight portion of the polymer will bond both pieces (base plate and foil with electrodes) together, additionally it will follow the shape of the printed electrodes, which can be between 5 and 30 ⁇ m thick.
  • the switching mechanism 404 allows the replacement of a used electrochemical system after a predetermined period of time.
  • an electrochemical system is prone to fouling due to precipitation or adsorption of proteins or other species on the electrode surface.
  • a different strategy is the protection of the electrode by a semi permeable membrane, which allows the analyte to pass through to the electrode but not a large protein (or a red blood cell). This concept is adopted in classical oxygen electrodes.
  • the chip 400 uses a mixture of both concepts: a plurality of electrodes in diff rent channels as well as an electrode protected by screen printable membrane (see German patent DE10052066.9 and related International patent application PCT/EP01/12073). This allows the sensor electrodes to operate for several hours before the fouling shows a significant effect on the results and before the controller is switching to the next channel.
  • FIG. 21 shows a schematic diagram of the switching mechanism 404 .
  • the switching system 404 includes electrodes 422 separate from the electrochemical detector electrodes 418 , 420 .
  • the switching electrodes 404 allow local heating of a very small area on the thin foil such as polystyrene 424 overlying a well 426 .
  • the well 426 is in fluid flow communication with the end of the reservoir 406 except that the fluid flow is normally blocked by the foil 424 . Due to this blockage, air cannot escape from the channel 402 and fluid from the distribution depression 416 cannot flow into the channel 402 . Upon heating of the foil, this blockage is removed thus allowing the fluid to enter the channel.
  • the temperature at the center point of the overlying electrodes 422 i.e., overlying the foil 424 above the well 426 ) very quickly rises over the glass transition temperature (T g ) of the foil in response to an application of a small current in the range of some ⁇ fraction (1/1000) ⁇ Ampere with the effect that the foil 424 forms an opening above the hydrophobic well 426 allowing air in the channel 402 and reservoir 406 to vent into the well 426 .
  • the gas pressure in the channel 402 is relieved and fluid can flow from the distribution depression 416 and into the channel 402 .
  • the hydrophobicity of the well 426 prevents the sample fluid from flowing into the well 426 and leaking out of an opening formed in the film by reason of the energized electrodes 404 .
  • the controller opens a subsequent channel 402 by energizing its switching electrodes 422 to permit air to escape from the channel 402 and for the subsequent channel 402 to fill with body fluid. It should be appreciated that other methods for switching between channels and controlling fluid flow could be used and the invention is not limited by the above method
  • the controller determine if the waste reservoir 406 is filled, is still filling at a constant rate, or if the needle 410 has dislodged from the cutaneous layer of the patient and the continuous sample stream has stopped.
  • the waste reservoir 406 can be equipped with two electrodes (not shown) at the top and the bottom of the reservoir. Not in electrical contact with the sample fluid, these electrodes could measure the change in capacitance while the air inside the structure is slowly exchanged with sample fluid. The rate of the capacitance change will be directly proportional to the flow rate of the sample fluid and allow a close monitoring of the ongoing extraction.
  • devices in accordance with the invention may measure the concentration of analytes other than those in bodily fluids.

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US7005857B2 (en) 2006-02-28
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