WO2005054846A1 - Ameliorations apportees a des dispositifs portables d'analyse - Google Patents

Ameliorations apportees a des dispositifs portables d'analyse Download PDF

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Publication number
WO2005054846A1
WO2005054846A1 PCT/GB2004/005094 GB2004005094W WO2005054846A1 WO 2005054846 A1 WO2005054846 A1 WO 2005054846A1 GB 2004005094 W GB2004005094 W GB 2004005094W WO 2005054846 A1 WO2005054846 A1 WO 2005054846A1
Authority
WO
WIPO (PCT)
Prior art keywords
meter
connector
electrostatic discharge
casing
programmable chip
Prior art date
Application number
PCT/GB2004/005094
Other languages
English (en)
Inventor
Steven Alexander Syme
Raymond John Welsh
Original Assignee
Lifescan Scotland Limited
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 Lifescan Scotland Limited filed Critical Lifescan Scotland Limited
Priority to AU2004294513A priority Critical patent/AU2004294513A1/en
Priority to CA002549288A priority patent/CA2549288A1/fr
Publication of WO2005054846A1 publication Critical patent/WO2005054846A1/fr
Priority to IL176096A priority patent/IL176096A0/en

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
    • G01N33/48785—Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply

Definitions

  • the present invention relates to a hand held analytical device and, more particularly, to an electronic discharge cover for use in such a device.
  • Hand held meters that are used for analysis of body fluids, for example, blood, interstitial fluid, urine etc can be adversely affected by electrostatic discharge. Such meters, which are often based on the principles of electro-chemical or photometric detection, may make use of disposable test sensors in the form of test strips. Test sensors can be inserted through a small aperture in the case or housing of the meter in order to form a physical and electrical connection with the electronic measuring system of the meter. Such hand held meters can be used to detect analytes or other indicators such as glucose, HbAlc, ketones and hematocrit in body fluids such as blood, interstitial fluid or urine etc.
  • analytes or other indicators such as glucose, HbAlc, ketones and hematocrit in body fluids such as blood, interstitial fluid or urine etc.
  • Such meters typically include a printed circuit board upon which electronic circuit components of the meter, and connections between these components, are provided as would be understood by someone skilled in the art.
  • a special connector called a strip port connector is mounted opposite the aperture in the meter for receipt of the disposable test sensor such as a test strip.
  • a data port with a jack socket can be provided for uploading information to the meter controller, typically a central processing unit, or memory, or for downloading information from the CPU or memory of the meter.
  • a simple hole in the case of the meter is provided to access one or more connection points on the PCB for uploading information to the meter memory or CPU, such as calibration information. Sometimes two or more holes can be so provided.
  • a relatively rigid flexible sticker with adhesive backing is placed over the hole or holes to prevent mechanical or electrical access to the inside of the meter via the case once the information has been uploaded to the meter.
  • a relatively rigid flexible panel is attached to the meter casing by separate adhesive to completely cover the hole or holes.
  • Such a sticker or flexible pad prevents access to the connection points on the PCB lying beneath the holes in the casing.
  • Static electricity can build up in the body of a human particularly when, for example, walking on a nylon carpet or vinyl floor or sitting on a stool made of a manmade material. It is not uncommon for static charges exceeding 30kV to be developed depending upon the temperature and relative humidity of the environment. Static will discharge from a body when it approaches or contacts material of differing potentials. Often the material of differing potential is connected to ground. Static discharge will typically follow the easiest route to this differing potential such as ground. Thus, for example, lightning is conducted to ground through a pointed lightning conductor attached to a building in preference to discharging through the building itself.
  • the internal components of the analytical device are vulnerable to static discharge to them via any openings in the meter casing such as the aperture for inserting a disposable test sensor or data port or any holes in the casing for accessing the PCB.
  • the present invention is directed to a meter for the detection of glucose, the meter including a programmable chip, an external opening through the meter housing, a connector for programming the programmable chip, wherein the connector is accessible through the external opening, and an electrostatic discharge cover adapted to protect the meter from electrostatic discharge by covering the connector.
  • the present invention may further include a meter wherein the connector includes a plurality of connector pins, the electrostatic discharge cover includes a plurality of protrusions including indentations, the protrusions being adapted to fit over the connector pins.
  • the present invention may further include a meter wherein the cover is removable.
  • the present invention may further include a meter wherein the programmable chip is an ASIC chip.
  • the present invention may further include a meter wherein the programmable chip is a memory chip.
  • a further embodiment of the present invention is directed to a method of programming a meter for the detection of glucose, wherein the meter comprises a programmable chip, an external opening through the meter housing, a connector for programming the programmable chip, and an electrostatic discharge cover adapted to protect the meter from electrostatic discharge by covering the connector.
  • the method comprises the steps of assembling the meter such that the connector extends through the meter casing, covering the connector with the electrostatic discharge cover, completing assembly of the meter, removing the electrostatic discharge cover to expose the connector, connecting to the exposed connector, programming the meter through the connector, replacing the electrostatic discharge cover.
  • Figure 1 is a perspective view of the front of a hand held meter for testing glucose according to the present invention.
  • Figure 1 A is a perspective views of the rear of a hand held meter for testing glucose according to the present invention.
  • Figure 2 is a plan view of the rear of the meter of Figure 1 according to an exemplary embodiment of the present invention.
  • Figure 3 is an elevation view of the rear half of the meter casing of the meter of Figures 1 and 2 along line A-A'.
  • Figure 4 is a plan view of the rear face of an internal printed circuit board of the meter of Figures 1 and 2.
  • Figure 5 is a plan view of an insert plug according to an exemplary embodiment of the present invention.
  • Figure 6 is a cross section along line B-B' of the insert of Figure 5.
  • Figure 7 is a plan view of a flexible second insert in the form of a flexible pad or sticker or label according to an exemplary embodiment of the present invention for use with the meter shown in Figures 1-3.
  • Figure 8 is a flow diagram illustrating a method of assembling a meter according to the present invention. Detailed Description of the Figures
  • Figure 1 shows a meter 2 having an aperture 4 at an end 5 of meter 2 for receiving a test sensor such as a disposable test strip such as, for example, the One Touch Ultra test strip available from LifeScan Inc., Milpitas, California, USA.
  • a test sensor such as a disposable test strip such as, for example, the One Touch Ultra test strip available from LifeScan Inc., Milpitas, California, USA.
  • a number of sloping lands 6 help guide a test strip on its approach to the meter and onwards into aperture 4.
  • a display 8 is provided to indicate the on/off status of the meter, the results of any test and test instructions.
  • a button 10 can be used to control the calibration code or enter memory mode. The strip insertion/retraction automatically controls the on/off status of the meter.
  • the meter casing is in two shaped halves 14 and 16 (as seen in Figure 3) which are snap fitted and/or ultrasonically welded together to provide a complete casing. Overlapping inter-engagement snapfit features are provided around the rim of first portion 14 of casing 12 along with corresponding features on the rim of second portion 16 of casing 12.
  • Such a meter is typically used for testing for glucose in blood, for example.
  • the user pricks their finger using a commercially available lancet such as the PenletPlus available from LifeScan Inc., Milpitas, California, USA.
  • the user deposits a drop of blood on a disposable strip which has been pre-inserted into aperture 4, guided by lands 6, to make connection with meter electronics inside casing 12.
  • the meter electronics then controls a test measurement of the blood on the strip to determine the concentration of glucose in the blood.
  • FIG 2 shows rear portion 16 in plan view and Figure 3 shows rear portion 16 in cross sectional view along line A-A'.
  • Casing portions 14 and 16 are formed by injection molding or other methods as understood by those skilled in the art. These are made from grey colored dielectric resin or plastic such as ABS type material available from DuPont or such as cycolac available from General Electric, USA.
  • a specially shaped clip 18 is made from the same material as portion 16 and is attached to casing 16.
  • Clip 18 can either be manufactured separately or integral with casing half 16.
  • Clip 18 has two large radius concave shaped edges 19 and one smaller radius convex shaped edge 21.
  • Clip 18 is slightly resiliently mounted with respect to casing 16 so that when the clip is placed over material of a pocket, the material is securely gripped between clip 18 and meter 16.
  • clip 18 abuts case half 16 near edge 21 so that clip 18 must be bent away from case 16 slightly when the fabric of a pocket is passed between clip 18 and casing half 16. This means that clip 18 is under tension and grips the fabric securely.
  • the shaped edges 19 and 21 of clip 18 facilitate easy insertion of clip 18 over the fabric of a pocket. Such an arrangement facilitates the easy storage of the hand held analytical device about a person.
  • the width of clip 18 is relatively large compared to the width of meter casing 16. At its widest point clip 18 is 24 mm, while at its narrowest point clip 18 may be 15 mm. Typically clip 18 is around 50 mm in length. Therefore, a relatively large region is provided in the centre of clip 18. This central region can be used for example for providing a label 23 with additional information for a user such as helpline number or an individual name tag to be written upon by a user.
  • a first relatively shallow four-sided rebate 20 is provided in rear portion 16 of meter casing 12. Rebate 20 can be seen clearly in Figures 2 and 3. The depth of rebate 20 is typically around 0.5 mm from the outline of the casing. Rebate 20 is shaped to correspond more or less with the outer edge of meter casing portion 16. A second rebate 25 is provided inwardly of rebate 20. Rebate 25 is a rectangular shape and is of relatively greater depth than the depth of rebate 20. Rebate 25 has a total depth of approximately 1 mm (typically 0.95 mm from the outline of the casing). A number of access holes 22, of diameter around 2mm, situated at the bottom of rebate 20, extend right through casing 12. Typically the casing and holes are 1.75mm in this region.
  • holes 22 are provided in the rear-casing portion 16 rather than the front casing portion 14, they may be provided in one or both portions.
  • Ten holes are provided in this particular embodiment, although differing numbers such as one or more, two or more and so on or greater than 10 holes can be provided as would be understood by someone skilled in the art.
  • FIG. 4 a plan view of the inside of meter 2, as if casing portion 16 were removed, is shown.
  • the rim of casing portion 14 can be seen.
  • the rear 7 of one of lands 6 can be seen at end 5 of meter 2.
  • a PCB 27 is also provided to which various components are attached as will be understood by those skilled in the art.
  • a number of contact points 24 are provided on PCB 27 at locations to correspond with the locations of holes 22 in casing portion 16.
  • a battery 28 is situated on PCB 27.
  • contact pads 24 are printed along with other similar components and contact pads for PCB 27 during the manufacture of the PCB. Thus, no additional processing steps are required at this stage.
  • Pads 24 typically comprise a gold layer (10 to 100 ⁇ m thick) that is electroplated onto the copper track of the PCB, revealed by etching of the PCB layout that is printed on the PCB blank. Pads 24 are electrically connected to components on the PCB 27 via the PCB, such as the ASIC 26 or to a separate CPU or memory.
  • insert plug 30 can be seen.
  • insert plug 30 is made from rigid plastic material. It may be made of grey colored resin or polymer material such as ABS type material available from DuPont or such as cycolac from General Electric, USA.
  • a number of spigots or upstanding protrusions or pegs 34 are provided in a layout to correspond to the layout of holes 22 in casing portion 16.
  • the size and shape of pegs 34 are sized and shaped to closely fit within holes 22.
  • the pegs 34 may be an interference fit with holes 22. While all holes 22 and pegs 34 are of the same size and shape in this embodiment, this needs not necessarily be the case. Indeed larger and/or smaller holes and/or holes of different shapes can be provided depending upon the requirements for electrical contact with PCB 27 via contact pads 24.
  • base 32 and/or pegs 34 may be made from an elastomeric material such as rubber or flexible plastic.
  • sticker pad 36 is provided.
  • Sticker 36 is typically made from a dielectric plastic such as Mylar. It may be in the form of a stickable label containing information such as a manufacturers details or calibration codes etc.
  • sticker 36 may have apre-applied layer of adhesive on one side to facilitate adhesion of sticker 36 within rebate 20, although it may do in another example . embodiment.
  • the size and shape of edge 38 of pad 36 corresponds to the size and shape of rebate 20.
  • the thickness of pad 36 is arranged to correspond to the thickness of the depth of rebate 20.
  • pad 36 may be flexible or rigid and may be an interference fit in rebate 20.
  • the outer edge 33 of insert plug 30 is sized and shaped to correspond closely to that of rebate 25.
  • insert 30 may be an interference fit in rebate 25.
  • the height of rigid base panel 32 is arranged to correspond to the depth of rebate 25. Such arrangements mean that when fully assembled the outer casing 16 is more or less flush with the outermost surface of flexible pad 36 and further the base of rebate 20 is substantially flat to receive sticker 36.
  • Adhesive 29 is provided around the outer edge of rebate 25 to fix pad 36 to casing 16. The adhesive may be provided in a continuous or discrete manner on casing 16.
  • PCB 27 is fixed within casing portion 14 and casing portion 16 is snap fitted and/or stuck onto casing portion 14 for example by ultrasonic welding.
  • plug 30 is optionally placed in rebate 25.
  • pegs 34 pass through and effectively close holes 22. This minimizes the width of any air gap in holes 22. Thus, the possibility of electrostatic discharge via these holes is reduced.
  • insert 30 is added to protect the meter from ESD during manufacture then prior to the following step it is removed. Contact is made to the PCB from outside the casing via pads 24 using electrical contact pins which access pads 24 via holes 22. Once uploading of information such as manufacturing parameters, and/or software and/or calibration information has taken place, insert 30 is replaced or added to casing portion 16. Thus, control software and/or calibration information and/or other information can be uploaded to the meter via holes 22 in casing 16. Insert 30 is placed in rebate 25, closing holes 22 in this example embodiment substantially entirely closing holes 22 so as to virtually eliminate an air gap.
  • insert 30 can be bonded to casing 16 by adhesive or otherwise.
  • insert 30 is removably attached to casing 16 for example using adhesive.
  • adhesive is applied either to casing 16 such as at regions 29 and/or to the rear surface of flexible pad 36 if it is not already provided with adhesive.
  • flexible pad 36 is attached to meter casing 16 within rebate 20 completely covering insert 30, which itself completely covers holes 22.
  • Removable insert 30 may optionally be fixed to casing 16 by adhesive or other means.
  • Pad 36 may be removable by breaking adhesive 29 and either wholly or partially removing adhesive 29 and replacing it with further adhesive or using a type of adhesive 29 that allows removal and replacement of pad 36 with no or little detriment to the adhesive effect between pad 36 and casing portion 16.
  • insert 30 provides a fallback arrangement to prevent ESD entering into the inside of meter casing 12.
  • insert 30 virtually eliminates any air gaps by the provision of pegs 34 which correspond to holes 22 in size and shape.
  • flexible pad 36 provides additional protection increasing the length of the air gap and therefore the length of travel of any electrostatic discharge.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Food Science & Technology (AREA)
  • Human Computer Interaction (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

Un mètre (2) pour la détection de glucose comprend une puce programmable (26) et un connecteur externe, comprenant des broches s'étendant à travers le boîtier du mètre, et programmant la puce programmable. Un mètre selon l'invention comprend en outre un couvercle de décharge électrostatique susceptible d'être retiré (30) apte à protéger le mètre d'une décharge électrostatique par la couverture des broches du connecteur.
PCT/GB2004/005094 2003-12-03 2004-12-02 Ameliorations apportees a des dispositifs portables d'analyse WO2005054846A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
AU2004294513A AU2004294513A1 (en) 2003-12-03 2004-12-02 Improvements relating to hand held anaytical devices
CA002549288A CA2549288A1 (fr) 2003-12-03 2004-12-02 Ameliorations apportees a des dispositifs portables d'analyse
IL176096A IL176096A0 (en) 2003-12-03 2006-06-04 Improvements relating to hand held anaytical devices

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US52708803P 2003-12-03 2003-12-03
US60/527,088 2003-12-03

Publications (1)

Publication Number Publication Date
WO2005054846A1 true WO2005054846A1 (fr) 2005-06-16

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Application Number Title Priority Date Filing Date
PCT/GB2004/005094 WO2005054846A1 (fr) 2003-12-03 2004-12-02 Ameliorations apportees a des dispositifs portables d'analyse

Country Status (4)

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AU (1) AU2004294513A1 (fr)
CA (1) CA2549288A1 (fr)
IL (1) IL176096A0 (fr)
WO (1) WO2005054846A1 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1783486A1 (fr) * 2005-10-17 2007-05-09 Lifescan, Inc. Méthode de mesure des fluides physiologiques
WO2008059336A2 (fr) * 2006-11-13 2008-05-22 Inverness Medical Switzerland Gmbh Dispositif et procédé de test
US7468125B2 (en) 2005-10-17 2008-12-23 Lifescan, Inc. System and method of processing a current sample for calculating a glucose concentration
EP2256712A1 (fr) * 2008-03-21 2010-12-01 ARKRAY, Inc. Dispositif médical
US7946171B2 (en) * 2007-03-28 2011-05-24 Roche Diagnostics Operations, Inc. Analysis device with housing lock mechanism
US8994395B2 (en) 2008-10-27 2015-03-31 Lifescan Scotland Limited Methods and devices for mitigating ESD events

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5366609A (en) * 1993-06-08 1994-11-22 Boehringer Mannheim Corporation Biosensing meter with pluggable memory key
EP0998176A2 (fr) * 1998-10-29 2000-05-03 Robert Bosch Gmbh Programmation d'unités de commande en boítier fermé
WO2000044213A1 (fr) * 1999-01-22 2000-07-27 Telefonaktiebolaget Lm Ericsson (Publ) Carte de circuit electronique, montage comprenant un materiau isolant et une carte de circuit electronique
WO2002078512A2 (fr) * 2001-04-02 2002-10-10 Therasense, Inc. Dispositif et procede de recherche de glucose dans le sang
US20020170823A1 (en) * 2001-05-18 2002-11-21 Housefield T. Scott Body fluid test apparatus with detachably mounted portable tester
US20030203498A1 (en) * 2002-04-25 2003-10-30 Home Diagnostics, Inc. System and methods for blood glucose sensing

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5366609A (en) * 1993-06-08 1994-11-22 Boehringer Mannheim Corporation Biosensing meter with pluggable memory key
EP0998176A2 (fr) * 1998-10-29 2000-05-03 Robert Bosch Gmbh Programmation d'unités de commande en boítier fermé
WO2000044213A1 (fr) * 1999-01-22 2000-07-27 Telefonaktiebolaget Lm Ericsson (Publ) Carte de circuit electronique, montage comprenant un materiau isolant et une carte de circuit electronique
WO2002078512A2 (fr) * 2001-04-02 2002-10-10 Therasense, Inc. Dispositif et procede de recherche de glucose dans le sang
US20020170823A1 (en) * 2001-05-18 2002-11-21 Housefield T. Scott Body fluid test apparatus with detachably mounted portable tester
US20030203498A1 (en) * 2002-04-25 2003-10-30 Home Diagnostics, Inc. System and methods for blood glucose sensing

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1783486A1 (fr) * 2005-10-17 2007-05-09 Lifescan, Inc. Méthode de mesure des fluides physiologiques
US7468125B2 (en) 2005-10-17 2008-12-23 Lifescan, Inc. System and method of processing a current sample for calculating a glucose concentration
EP2261651A1 (fr) * 2005-10-17 2010-12-15 LifeScan, Inc. Méthode de mesure des fluides physiologiques
US8066866B2 (en) 2005-10-17 2011-11-29 Lifescan, Inc. Methods for measuring physiological fluids
US8093903B2 (en) 2005-10-17 2012-01-10 Lifescan, Inc. System and method of processing a current sample for calculating a glucose concentration
US8486245B2 (en) 2005-10-17 2013-07-16 Lifescan, Inc. Methods for measuring physiological fluids
WO2008059336A2 (fr) * 2006-11-13 2008-05-22 Inverness Medical Switzerland Gmbh Dispositif et procédé de test
WO2008059336A3 (fr) * 2006-11-13 2008-11-27 Inverness Medical Switzerland Dispositif et procédé de test
US7946171B2 (en) * 2007-03-28 2011-05-24 Roche Diagnostics Operations, Inc. Analysis device with housing lock mechanism
EP2256712A1 (fr) * 2008-03-21 2010-12-01 ARKRAY, Inc. Dispositif médical
EP2256712A4 (fr) * 2008-03-21 2015-04-08 Arkray Inc Dispositif médical
US8994395B2 (en) 2008-10-27 2015-03-31 Lifescan Scotland Limited Methods and devices for mitigating ESD events

Also Published As

Publication number Publication date
AU2004294513A1 (en) 2005-06-16
IL176096A0 (en) 2006-10-05
CA2549288A1 (fr) 2005-06-16

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