WO2006059241A2 - Dispositif de detection d'analytes monte sur un substrat flexible - Google Patents

Dispositif de detection d'analytes monte sur un substrat flexible Download PDF

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Publication number
WO2006059241A2
WO2006059241A2 PCT/IB2005/004101 IB2005004101W WO2006059241A2 WO 2006059241 A2 WO2006059241 A2 WO 2006059241A2 IB 2005004101 W IB2005004101 W IB 2005004101W WO 2006059241 A2 WO2006059241 A2 WO 2006059241A2
Authority
WO
WIPO (PCT)
Prior art keywords
container
film
analyte sensing
sensing devices
analyte
Prior art date
Application number
PCT/IB2005/004101
Other languages
English (en)
Other versions
WO2006059241A3 (fr
Inventor
Norbert Bartetzko
Original Assignee
Albatros Technologies Gmbh & Co. Kg
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Albatros Technologies Gmbh & Co. Kg filed Critical Albatros Technologies Gmbh & Co. Kg
Publication of WO2006059241A2 publication Critical patent/WO2006059241A2/fr
Publication of WO2006059241A3 publication Critical patent/WO2006059241A3/fr

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/4875—Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method
    • G01N33/48764—Test tape taken off a spool

Definitions

  • the technical field relates to analyte detecting devices, and more specifically, to sample capture and the use of analyte detecting devices.
  • Test strips are known in the medical health-care products industry for analyzing analyte levels such as but not limited to, glucose levels in blood.
  • a drop of blood is typically obtained by making a small incision in the fingertip, creating a small wound, which generates a small blood droplet on the surface of the skin.
  • a test strip is brought by the user to the blood droplet at the wound and engaged in a manner to bring blood to an analysis site on the test strip.
  • the test strip is then coupled to a metering device which typically uses an electrochemical technique to determine the amount of glucose in the blood.
  • a further impediment to patient compliance is the amount of time that it takes for a glucose measurement to be completed.
  • Known devices can take a substantial amount of time to arrive at a glucose level. The more time it takes to arrive at a measurement, the less the likely that the user will stay with their testing regime.
  • a further impediment to patient compliance is the amount of time that at lower volumes, it becomes even more important that blood or other fluid sample be directed to a measurement device without being wasted or spilled along the way.
  • Known devices do not effectively handle the low sample volumes in an efficient manner. Accordingly, improved sensing devices are desired to increase user compliance and reduce the hurdles associated with analyte measurement.
  • the present invention provides solutions for at least some of the drawbacks discussed above. Specifically, some embodiments of the present invention provide an improved apparatus for measuring analyte levels in a body fluid. The present invention also provided improved techniques for sample capture used with such analyte detecting devices. Some embodiments may present an orthogonal arrangement of penetrating and sensing module including sample capture. At least some of these and other objectives described herein will be met by embodiments of the present invention.
  • Figure 1 shows one embodiment of the present invention.
  • Figure 2 shows a top down cross-sectional view of the device of Figure 1.
  • Figure 3 is a perspective view of a device according the present invention used with a cartridge containing a plurality of penetrating members.
  • Figure 4 is an exploded perspective view of another embodiment of the present invention with a housing with a display.
  • Figures 5 and 6 show a plurality of testing devices arranged in linear configurations.
  • Figure 7 shows one embodiment of a flexible substrate having a plurality of testing devices.
  • Figure 8 shows another embodiment of a flexible substrate having a plurality of testing devices. DESCRIPTION OF THE SPECIFIC EMBODIMENTS
  • Optional or “optionally” means that the subsequently described circumstance may or may not occur, so that the description includes instances where the circumstance occurs and instances where it does not.
  • a device optionally contains a feature for analyzing a blood sample, this means that the analysis feature may or may not be present, and, thus, the description includes structures wherein a device possesses the analysis feature and structures wherein the analysis feature is not present.
  • integration is at the level of the device rather that on the disposable.
  • the contamination/hygiene issue is resolved because the finger touches only a new front end for each testing event. In a sense, this has disintegrated the integrated M2 disposable. Packaging and desiccant issues are solved.
  • a vial with a cap containing desiccant may be used.
  • Embodiments of the present invention may get around the problem of having to individually seal the analyte sensing devices and open them at the same time as the penetrating member chambers are opened.
  • the invention comprises of a canister 10 having a plurality of analyte sensing devices 12 on a film 14 instead of a disk.
  • the analyte sensing devices may be linearly spaced and may be coupled to a mesh for improved sample capture. After (or before) each use, the film is advanced to present a fresh unused analyte sensing device 12 and mesh combination.
  • analyte sensing devices 12 may be spaced on a film such that at any point only one analyte sensing device 12 is exposed to the open environment or available for use.
  • New, unused analyte sensing devices 12 may be housed in a storage container 16 and used analyte sensing devices 12 may be placed in another container 18.
  • the containers 16 and 18 may each or both have seals mounted at the openings to keep their interior environment in a sealed condition.
  • the film 14 may also include holes 20 along the edges of the film.
  • these holes 20 may be used to act as guides for the film. In other embodiments, they may be used as tractor holes to advance the film.
  • the holes may be round, square, triangular, other shaped, or combination of any of the above. Still other embodiments may use the holes for indexing to determine position of the film and whether an analyte sensing device 12 is properly positioned.
  • Figure 2 shows a top down, cross-sectional view of the embodiment of Figure 1.
  • the film 14 may support an analyte sensing device 12.
  • the film 14 may rolled inside the containers 16 and 18 to maximize the number of analyte sensing devices 12 that may be held in each container 16 or 18.
  • seal elements 19 shown in phantom
  • These may be rubber flaps or polymer elements.
  • Figure 3 shows the canister 10 positioned so that a penetrating member 22 from the radial cartridge 24 will pass through an opening on the analyte sensing device 12 and pierce tissue to sample body fluid.
  • the tip of the penetrating member 22 extends through the plane of the sensing device 12 without having to pierce it. In other embodiments, the tip will pierce a mesh placed in the opening to facilitate sample capture.
  • the radial cartridge 24 may contain a plurality of penetrating members 22 so that a plurality of analyte sensing devices 10 may be mated with a plurality of penetrating members 22. This allows for multiple lancing and analyte measurement events.
  • the radial cartridge 24 may rotate to bring a new, unused penetrating member into an active position for lancing. This may occur as the user readies the device for a new lancing event. In other embodiments, this may occur immediately after a lancing event.
  • the canister 10 may also be configured to advance the film 14 in a manner coordinated with the rotation of the radial cartridge 24 so that an unused analyte sensing device is presented when an unused penetrating member is brought to the active position, m some embodiments, the movement of the radial cartridge 24 and the film 14 in canister 10 are not linked. Both the canister 10 and the radial cartridge 24 may be enclosed in one device with one housing, thus creating an integrated device for lancing and for measurement of analytes. In other embodiments, the canister 10 may be in a separate housing that is mated to another housing that contains the radial cartridge 24 with its penetrating members. The penetrating members in the cartridge 24 may be bare lancets without any molded parts which increase manufacturing cost.
  • Figure 4 shows an exploded perspective view of another embodiment of the present invention.
  • the canister 10 is contained in a separate housing 30.
  • the housing 30 may include a window 32 that allows for an analyte sensing device 12 to be accessible to the user. A new, unused analyte sensing device 12 positioned in the window 32 is considered to be in an active position.
  • the housing 30 may also include a display 34 for showing analyte measurements. Some embodiments may also show other information such as but not limited to battery status, date/time, number of unused analyte sensing devices 12 remaining in the canister, number of used analyte sensing devices 12, error signals, or other information to the user.
  • the housing 30 may also include buttons to control the device.
  • a lever 40 may also be on the housing to allow the user to mechanically advance the film 14 that supports the device 12. In other embodiments, an electric motor or other powered actuator may be used to advance the film 14.
  • a gear 42 in or on the container 10 may be used to rotate a spool 44 of the film 12. Some embodiments may have only one spool of the container 10 that is driven to advance the film, while others may have both spools driven.
  • the housing 30 may be designed to mate with the housing of a penetrating member driver. This penetrating member drive may contain one, two, or two or more penetrating members. Having multiple penetrating members allows the same device to be used for multiple testing events without reloading.
  • the device includes a hole or opening 50 through which a penetrating member can pass.
  • Body fluid drawn from a patient will be captured and spread over the electrodes 52 on the device.
  • the electrodes 52 are connected by conductive lines to contact pads 54 which can carry electrical signals from the electrodes to a meter that measures the analyte levels in the fluid over the electrodes 52.
  • FIG. 5 shows that the analyte sensing devices 12 may be manufactured one next to another and then separated into individual members 12.
  • the device may include three electrodes 52, each used for a test event.
  • the electrodes 52 may be a working electrode, a reference electrode, and a counter electrode.
  • only the working electrode includes enzymes or reagents for reacting with the analyte.
  • hydrophilic film 53 covers all three electrodes.
  • Other embodiments may have a film 55 that only covers two electrodes.
  • FIG. 6 shows that the individual analyte sensing devices may then be placed on a film or other flexible substrate 14 which may then be placed inside canister 10.
  • a film or other flexible substrate 14 which may then be placed inside canister 10.
  • each analyte sensing device 12 may have an opening 56.
  • the opening may be a true opening or include a mesh 60.
  • Figure 7 shows that in one embodiment, the analyte sensing devices 12 may be mounted on a film 14 that includes holes 20 which may be used for indexing, tractoring, or other functions, depending on the device using the film. Some embodiments may have the sensing devices 12 mounted flush with the film 14.
  • Figures 8A-8E show one embodiment where a mesh 60 may be placed in the opening 50 of the analyte sensing device 12. Blood or body fluid delivery can be aided via a mesh lollipop that may be entirely fill the opening 50 or partially fill the opening 50.
  • Figure 8A shows that the film 14 and member 12 may be mounted to be on a front end of a penetrating member driving device 62. The device 62 may use an electromechanical driver to advance the penetrating member such as that described in US application 10/127,395 fully incorporated by reference herein for all purposes. U.S. Provisional Application 60/625,500 is also fully incorporated herein by reference for all purposes.
  • Figure 8B shows that the device may be arranged in a film canister type configuration.
  • Figure 8C shows three electrodes 52 mounted on a sensing device.
  • Figure 8D dhows that the hole 56 may include a mesh to improve sample capture.
  • the tractor holes 20 may also be used to align the film and the contact pads 63.
  • Figure 8E also shows the contact pads 63.
  • the advantages of the present design include reduced contamination problem, easy packaging & humidity control, and low blood sample volume. Prevention of air-borne contamination into new detecting members cap may be an issue however.
  • the device desires to have low humidity over 60 days. Detecting-member-to-detecting-member isolation and detecting-member-to-penetrating-member isolation is implicit in the design therefore simplifying sterilization. In addition, no air vent is needed, nor is an additional disposable front end.
  • low production costs (5 x 5 mm analyte sensing devices) can be achieved by using high density printing of analyte sensing devices 12 which are then placed in the film 14 in a separated manner allowing sample capture without contamination of the nearest neighbor.
  • High volume production may be possible by drawing from electronic and semi-conductor industry: pick and place, robotics, etc.
  • the desiccant will be easy to add.
  • the present invention may be configured to individually seal each analyte sensing device with desiccant in a blister or in the cap.
  • the electrical contact to the meter should be straightforward.
  • the sensing devices may be located at the instrument front end. In some embodiments, there is no physical connection between lancing and sensing module.
  • the present invention may include a method of manufacturing of placing the sensing devices 12 onto the film or flexible substrate 14 and then having at least a portion wound into a container to maintain sterility. Desiccant may also be included in the container 16 or 18.
  • the low volume analyte sensing device may be used with any of the cartridges disclosed herein or in related patent applications.
  • the publications discussed or cited herein are provided solely for their disclosure prior to the filing date of the present application. None herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed. All publications mentioned herein are incorporated herein by reference to disclose and describe the structures and/or methods in connection with which the publications are cited.

Abstract

La présente invention a trait à un dispositif destiné à être utilisé avec un compteur pour la mesure de niveaux d'analyte. Dans un mode de réalisation, le dispositif comporte un film et une pluralité de dispositifs de détection d'analyte monté sur le film. Le dispositif peut également inclure un premier réceptacle renfermant un film présentant des dispositifs de détection d'analyte non utilisé et un deuxième réceptacle conformé pour contenir un film avec des dispositifs de détection d'analyte utilisé, dans lequel le film s'étend depuis le premier réceptacle jusqu'au deuxième réceptacle pour le transport de dispositifs de détection d'analyte utilisé entre les réceptacles. Les dispositifs de détection d'analyte peuvent comporter une pluralité d'électrodes en liaison électrique avec des plages de contact agencées pour la transmission du signal au compteur.
PCT/IB2005/004101 2004-11-05 2005-11-07 Dispositif de detection d'analytes monte sur un substrat flexible WO2006059241A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US62550004P 2004-11-05 2004-11-05
US60/625,500 2004-11-05

Publications (2)

Publication Number Publication Date
WO2006059241A2 true WO2006059241A2 (fr) 2006-06-08
WO2006059241A3 WO2006059241A3 (fr) 2006-08-03

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1815785A1 (fr) * 2006-02-02 2007-08-08 Bioception B.V.i.o. Dispositif en forme d'une cassette pour le diagnostic de fluides
EP1852699A1 (fr) * 2006-05-06 2007-11-07 F.Hoffmann-La Roche Ag Unité d'analyse diagnostique avec un réservoir de supports d'essai
EP2213230A1 (fr) * 2009-02-03 2010-08-04 Roche Diagnostics GmbH Système de connexion et cassette à bande pour un appareil de connexion
GB2469070A (en) * 2009-03-31 2010-10-06 Diamatrix Ltd Test material and cassette for bio-sensing
EP2345368A1 (fr) * 2010-01-19 2011-07-20 Becton, Dickinson and Company Mécanisme de positionnement d'une bandelette de détection
JP2011147776A (ja) * 2010-01-19 2011-08-04 Becton Dickinson & Co 血液検査センサストリップのための電極配置

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5320734A (en) * 1989-12-05 1994-06-14 Daikin Industries, Ltd. Test apparatus for measuring concentration of test substance in liquid
DE19819407A1 (de) * 1998-04-30 1999-11-11 Hendrik Priebs Teststreifenbehälter für Messgeräte, die mit Einwegteststreifen arbeiten
DE19849539A1 (de) * 1998-10-27 2000-05-04 Simons Hans Juergen Portables Blutzuckermeßgerät
WO2000028068A1 (fr) * 1998-11-11 2000-05-18 Cambridge Sensors Limited Bandes electrodes permettant de tester des petits volumes
WO2001023885A1 (fr) * 1999-09-27 2001-04-05 Hypoguard Limited Dispositif d'analyse
WO2001073109A2 (fr) * 2000-03-28 2001-10-04 Diabetes Diagnostics, Inc. Procede de fabrication en continu de capteur electrochimque jetable
DE10032042A1 (de) * 2000-07-05 2002-01-24 Inventus Biotec Gesellschaft Fuer Innovative Bioanalytik, Biosensoren Und Diagnostika Mbh & Co. Kg Elektrochemischer Einwegbiosensor für die quantitative Bestimmung von Analytkonzentrationen in Flüssigkeiten
WO2002100274A1 (fr) * 2001-06-08 2002-12-19 Hoffmann-La Roche Ag Dispositif de prelevement de liquide corporel et cassette a support d'essai destinee a etre utilisee avec ledit dispositif
EP1360935A1 (fr) * 2002-05-09 2003-11-12 Lifescan, Inc. Band contenant des appareils pour la collecte et l'analyse d'échantillons de fluid et méthodes pour la produire, l'utiliser et l'emballer

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5320734A (en) * 1989-12-05 1994-06-14 Daikin Industries, Ltd. Test apparatus for measuring concentration of test substance in liquid
DE19819407A1 (de) * 1998-04-30 1999-11-11 Hendrik Priebs Teststreifenbehälter für Messgeräte, die mit Einwegteststreifen arbeiten
DE19849539A1 (de) * 1998-10-27 2000-05-04 Simons Hans Juergen Portables Blutzuckermeßgerät
WO2000028068A1 (fr) * 1998-11-11 2000-05-18 Cambridge Sensors Limited Bandes electrodes permettant de tester des petits volumes
WO2001023885A1 (fr) * 1999-09-27 2001-04-05 Hypoguard Limited Dispositif d'analyse
WO2001073109A2 (fr) * 2000-03-28 2001-10-04 Diabetes Diagnostics, Inc. Procede de fabrication en continu de capteur electrochimque jetable
DE10032042A1 (de) * 2000-07-05 2002-01-24 Inventus Biotec Gesellschaft Fuer Innovative Bioanalytik, Biosensoren Und Diagnostika Mbh & Co. Kg Elektrochemischer Einwegbiosensor für die quantitative Bestimmung von Analytkonzentrationen in Flüssigkeiten
WO2002100274A1 (fr) * 2001-06-08 2002-12-19 Hoffmann-La Roche Ag Dispositif de prelevement de liquide corporel et cassette a support d'essai destinee a etre utilisee avec ledit dispositif
EP1360935A1 (fr) * 2002-05-09 2003-11-12 Lifescan, Inc. Band contenant des appareils pour la collecte et l'analyse d'échantillons de fluid et méthodes pour la produire, l'utiliser et l'emballer

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1815785A1 (fr) * 2006-02-02 2007-08-08 Bioception B.V.i.o. Dispositif en forme d'une cassette pour le diagnostic de fluides
US8187537B2 (en) 2006-05-06 2012-05-29 Roche Diagnostics Operations, Inc. Diagnostic test unit with a container for test carriers
EP1852699A1 (fr) * 2006-05-06 2007-11-07 F.Hoffmann-La Roche Ag Unité d'analyse diagnostique avec un réservoir de supports d'essai
WO2007128758A1 (fr) * 2006-05-06 2007-11-15 F. Hoffmann-La Roche Ag Unité de test de diagnostic
US8870789B2 (en) 2009-02-03 2014-10-28 Roche Diagnostics Operations, Inc. Lancing system and tape cassette for a lancing device
WO2010088948A1 (fr) * 2009-02-03 2010-08-12 Roche Diagnostics Gmbh Système à lancettes, et cassette à bande pour un appareil à lancettes
EP2213230A1 (fr) * 2009-02-03 2010-08-04 Roche Diagnostics GmbH Système de connexion et cassette à bande pour un appareil de connexion
GB2469070A (en) * 2009-03-31 2010-10-06 Diamatrix Ltd Test material and cassette for bio-sensing
WO2010112834A1 (fr) 2009-03-31 2010-10-07 Diamatrix Limited Matériau d'examen, cassette et compteur utilisant le matériau d'examen
US20120094369A1 (en) * 2009-03-31 2012-04-19 James Richard Jackson Test Material, Cassette and Meter for Using the Test Material
EP2345368A1 (fr) * 2010-01-19 2011-07-20 Becton, Dickinson and Company Mécanisme de positionnement d'une bandelette de détection
JP2011147776A (ja) * 2010-01-19 2011-08-04 Becton Dickinson & Co 血液検査センサストリップのための電極配置
JP2011149940A (ja) * 2010-01-19 2011-08-04 Becton Dickinson & Co センサストリップ位置決め機構
JP2014222255A (ja) * 2010-01-19 2014-11-27 ベクトン・ディキンソン・アンド・カンパニーＢｅｃｔｏｎ， Ｄｉｃｋｉｎｓｏｎ Ａｎｄ Ｃｏｍｐａｎｙ 血液サンプルの検査装置
US8956309B2 (en) 2010-01-19 2015-02-17 Becton, Dickinson And Company Sensor strip positioning mechanism
US10203296B2 (en) 2010-01-19 2019-02-12 Becton, Dickinson And Company Electrode layout for blood test sensor strip

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