WO2006070199A1 - An analyte test meter having a test sensor port - Google Patents

An analyte test meter having a test sensor port Download PDF

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Publication number
WO2006070199A1
WO2006070199A1 PCT/GB2005/005105 GB2005005105W WO2006070199A1 WO 2006070199 A1 WO2006070199 A1 WO 2006070199A1 GB 2005005105 W GB2005005105 W GB 2005005105W WO 2006070199 A1 WO2006070199 A1 WO 2006070199A1
Authority
WO
WIPO (PCT)
Prior art keywords
test sensor
meter
housing
sensor port
strip
Prior art date
Application number
PCT/GB2005/005105
Other languages
French (fr)
Inventor
Steven Alexander Syme
James Raymond Parent
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
Priority to US64041504P priority Critical
Priority to US60/640,415 priority
Application filed by Lifescan Scotland Limited filed Critical Lifescan Scotland Limited
Publication of WO2006070199A1 publication Critical patent/WO2006070199A1/en

Links

Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/48785Electrical 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement

Abstract

A meter or system (100) having a housing (102) : a test sensor port in the housing; an upper edge in the test sensor port and a lower adge in the test sensor port wherein a test sensor can be inserted into the test sensor port between the upper and lower edges and further wherein at least one of the upper and lower edges is located inwardly of the other of the upper and lower edged towards the centre of the housing. The lower edge may be located inwardly with respect to the upper edge in a direction towards the centre of the housing. The distance by which the one edge extends beyond the other may be between o.5 and 1.5mm or between 0.9 and 1.1mm or around 0.95mm. The test sensor may be substantially rectangular, square, oval, circular, polygonal or the like.

Description

AN ANALYTE TEST METER HAVING A TEST SENSOR PORT

BACKGROUND OF INVENTION

1. Field of the Invention

The invention relates to a meter or system and a method of using such a meter or system for measuring an analyte or indicator in a body fluid for example the concentration of glucose in body fluid, such as blood, urine, plasma or interstitial fluid.

2. Background to the Invention

Meters or devices for measuring an analyte or indicator, e.g. glucose, HbAIc, lactate, cholesterol, in a fluid such as a body fluid, e.g. blood, plasma, interstitial fluid (ISF), urine, typically make use of disposable test sensors. A test sensor that is specific for the analyte or indicator of interest may be inserted within a connector in the meter or system, or be delivered to a test location from within the meter or system. The test sensor becomes physically and electrically connected with a measuring circuit. A sample, for example blood, plasma, interstitial fluid (ISF) or urine, will typically contain numerous soluble or solubilised components, one of which will be the analyte or indicator of interest. An example user group that might benefit from the use of such a meter or system is those affected with diabetes and their health care providers.

3. Summary of the Invention

Many aspects of the invention will be apparent from the following paragraphs and detailed description some of which are as follows. In one embodiment of the present invention there is provided a meter or system having a housing: a test senor port in the housing; an upper edge in the test sensor port and a lower edge in the test sensor port wherein a test sensor can be inserted into the test sensor port between the upper and lower edges and further wherein at least one or the upper and lower edges is located inwardly of the other of the upper and lower edges towards the centre of the housing. The lower edge may be located inwardly with respect to the upper edge in a direction towards the centre of the housing. In a further embodiment of the present invention there is provided a meter having a housing: a test sensor port in the housing; an upper edge in the test sensor port; a lower edge in the test sensor port, wherein the portion of the housing leading to the upper edge in the test sensor port overlaps and extends beyond a portion of the housing leading to a lower edge of the test sensor port. The distance by which the one edge extends beyond the other may be between around 0.5 and 1.5mm or between around 0.9 and 1.1mm or around 0.95mm. In a further embodiment of the present invention, the test sensor port may be substantially rectangular, square, oval, circular, polygonal or the like. In a further embodiment of the present invention, an upper edge of the test sensor port has a chamfered lead-in surface. In a further embodiment of the present invention, the chamfered lead- in surface is substantially arcuate in cross section.

4. Brief Description of the Drawings

A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, by way of example only, in which the principles of the invention are utilized, and in the accompanying drawings of which:

Figure 1 shows a schematic view of a system incorporating for example a meter and strip according to an embodiment of the invention.

Figure 2 shows a perspective exploded view from above of a meter or system for use, for example, as a blood glucose meter or system;

Figure 3 shows a perspective exploded view from below of a meter or system for use, for example, as a blood glucose meter or system;

Figure 4 shows an external perspective view of an upper housing for use in the meter or system of Figures 2 and 3;

Figure 5 shows an internal perspective view of the upper housing of Figure 4, for use in the meter or system of Figures 2 and 3;

Figure 6 shows an external plan view of the upper housing of Figure 4, for use in the meter or system of Figures 2 and 3;

Figure 7 shows a side elevation view of the upper housing of Figures 4, 5 and 6, for use in the meter or system of Figures 2 and 3; Figure 8 shows an internal plan view of the upper housing of Figure 5, for use in the meter or system of Figures 2 and 3;

Figure 9 shows an end on elevation view of the upper housing of Figures 4 to 8, for use in the meter or system of Figures 2 and 3;

Figure 10 shows an external plan view of an upper housing for use in the meter or system of Figures 2 and 3;

Figure 11 shows an external perspective view of upper housing of Figure 10, for use in the meter or system of Figures 2 and 3;

Figure 12 shows a close-up elevation view of one end of housing of Figures 10 and 11, for use in the meter or system of Figures 2 and 3;

Figure 13 shows a close-up perspective view of one end of housing of Figures 10 to 12, for use in the meter or system of Figures 2 and 3.

Detailed Description of the Drawings

Figure 1 shows a meter 100, housing 102, buttons 104, serial port 106, display 108, test sensor e.g. a strip 110, strip reaction zone 112, sample droplet e.g. interstitial fluid, plasma, blood or control solution 114, personal or network computer 116. A system comprising a meter 100 plus strips 110 is used for the quantitative determination of an analyte e.g. glucose in a body fluid e.g. capillary blood by health care professionals or lay persons in the home e.g. for the self monitoring of blood glucose. Results are expressed in mg/dl or mmol/1 on display 108. Here, the system comprises at least one disposable reagent strip 110 and the hand-held meter 100, 102, optionally including a computer 116. The user inserts one end of a strip 110 into meter 100, 102 and places a small (approx. lμl) blood sample on the other end. By applying a small voltage across the blood sample and measuring the resulting electric current versus time, the meter is able to determine the glucose concentration. The result is displayed on the meter's liquid crystal display 108. The meter logs each glucose measurement typically along with a date and time stamp in a memory (not shown). The user is able to recall these measurements and using suitable internal or external software, the user may view glucose measurements on the display 108 or download glucose measurements to a PC or networked computer for further analysis. An example strip port connector 1032 is that found in the One Touch Ultra meter available from LifeScan Inc., Milpitas, California.

Figure 2 shows an exploded view of meter 200. Meter 200 includes a housing cover 202, a clear viewing portion 204, an opaque portion 205, an upper housing 206, a housing cover recess 208, a button module 210, a PCB with components 212, an LCD module 214, a serial jack 228, battery identification and removal ribbons 230, a lower housing 232, batteries 234, a battery door 240, a battery door clip 236, a battery door hinge 238 and a battery door sticker 242.

Printed circuit board with components 212 is approximately oval, and includes a serial port connector 228 and a liquid crystal display (LCD) module 214. Strip port connector module 216 is mounted at one end of PCB 212, opposite strip delivery notch 220. LCD module 214 optionally comprises a substantially planar LCD behind which is located a substantially planar light guide of translucent plastic. Optionally, the light guide can be used to provide a backlight to the LCD within LCD module 214. LCD display module 214 is mounted to PCB 211 by means of LCD module mounting clips 224 and a number of locating pins (not shown). LCD module mounting clips 224 clip onto PCB 211 at LCD module mounting notches 222. Three button contact pads 226 are also located on PCB 21 1. A serial port connector in the form of a data jack 228 is at one end of PCB 21 1. Two battery cages 215 are on the rear side of PCB 211. LCD module 214 may be powered by a 6-way ribbon cable for example (not shown).

Figure 3 shows a meter 200, a housing cover 202, a housing cover notch 235, an upper housing 206, a strip guide and viewing notch 207, a strip delivery land 209, a button module 210, button module contact pads 213, a PCB including components 212, a PCB 211, an LCD module mounting clip 224, a serial port connector 228, battery identification and removal ribbons 230, a lower housing 232, batteries 234, a battery door 240, a battery door clip 236 and a battery door sticker 242.

Housing cover 202 is curved to match substantially the curve of upper housing 206. Housing cover 202 fits within correspondingly shaped and curved housing cover recess 208 and is primarily to cover and optionally protect the housing and the LCD module 214 when in place. Housing cover 202 has a clear viewing area 204. Typically clear viewing area 204 is sized and shaped to allow viewing access of LCD module 214 when LCD module 214 is mounted on PCB 211 within the upper housing 206.

In one example embodiment housing cover notch 235 is sized and shaped (optionally, arcuate) to correspond to the top of strip guide and viewing notch 207 in upper housing 206. Housing cover 202 is made from polycarbonate and has an opaque design imprinted on a correspondingly sized and shaped sticker (not shown) on the surface facing the inner concave surface of the housing cover prior to mounting in housing cover recess 208 on upper housing 206. The outer outline of the opaque design is sized and shaped substantially to match to outer outline of housing cover 202.

Two aspects of the invention will now be described in connection with firstly Figures 4 to 9, and secondly Figures 10 to 13. These aspects of the invention may be used independently or in conjunction with one another. In one aspect of the invention, Figures 4, 5, 6, 7, 8 and 9 show upper housing 206, a strip port 203, a housing cover recess 208, button holes 221, an LCD module viewing hole 219, a strip guide and viewing notch 207, a strip delivery land 209, a strip receiving gap 223, a strip receiving gap viewed from above 227 and PCB mounting features 225. In this arrangement LCD module 214 is opposite LCD module viewing hole 219 and clear viewing area 204 of housing cover 202. Similarly, button module 210 is mounted within upper housing 206 so that buttons 104 fit within button mounting holes 221. In this position button contact pads 213 are opposite the three button contact pads 226 on PCB 211.

In one example embodiment, PCB strip delivery notch 220 is arcuate in shape. Optionally, PCB strip delivery notch 220 may be sized and shaped as in this example embodiment to correspond to the size and/or shape of strip delivery land 209 of upper housing 206 (as seen in more detail in Figures 3, 5, 6 and 13). Optionally, one may be the inverse of the other so that these match in shape or size. Indeed optionally, PCB strip delivery notch 220 may be concave and strip delivery land 209 is concave in shape. Optionally, PCB strip delivery notch 220 may protrude beyond the natural outline, herein oval outline, of PCB 21 1 for example as shown. PCB strip delivery notch 220 and strip delivery land 209 are both arcuate in this embodiment, these may be differently sized and/or shaped for example square, rectangular, castellated, saw tooth, circular, oval and so on. Optionally, PCB strip delivery notch 220 and strip delivery land 209 are sized and shaped so that these substantially abut one another over part or all of the width of strip port 203. In such a case it is less likely that a strip may inadvertently be pushed under PCB 211 when it is inserted into strip receiving gap 223. If there is a minimal gap between PCB strip delivery notch 220 and strip delivery land 209 of upper housing 206, there is a reduced chance of electro-static discharge reaching the rear of PCB 211. Optionally, PCB strip delivery notch 220 and strip delivery land 209 are substantially co-planer so as to provide a smooth surface over which a test sensor such as a strip can slide.

The second aspect of the invention is seen in Figures 10, 11, 12 and 13. Figure 10 shows a plan view of an upper housing 206 in which, the strip-receiving gap 223 is hidden from view when viewed from above because strip-receiving land 209 extends inwardly into the meter.

Figure 10 shows an upper housing 206, a strip guide and viewing notch 207, a strip delivery land 209, a strip receiving gap 223, an angled side wall 229, angle 231 of angled side wall 229, an opaque portion 205 of housing lens cover 202 and a clear portion 204 of housing lens cover 202.

Figure 11 shows the perspective view of the alternative upper housing 206 of Figure 10 comprising button holes 221, an LCD module viewing hole 219, a strip delivery land 209, a strip guide and viewing notch 207, a strip receiving gap 223, a strip delivery land 209, a chamfered upper edge 233, an angled side wall 229, angle 231 of angled wall 229 and a lowermost surface 217 of housing cover recess 208.

Here it can be seen that the edge of strip delivery land 209 extends inwardly into upper housing 206 beyond the upper edge of strip receiving gap 223 by a distance d2 of between around 0.5 and 1.5mm and optionally around 0.9 to 1.lmm or around 0.95mm. Strip-receiving gap 223 of strip port 203 has angled sidewalls 229 with a change of angle 231. Because of the arcuate shape of strip guide and viewing notch 207 this means that initially a strip entering the housing encounters a broader gap at the start of strip delivery land 209 than towards the inner edge of strip delivery land 209. This may help guide the strip into the meter. Extension of strip delivery land 209 into the meter may optionally be combined with provision of a convex shape to minimise the distance from PCB 211 (not shown), as previously described. Further, optional changes are the increase in length and/or radius of curvature of the chamfered upper edge 233 of the strip port further helping to guide the strip into the meter.

Figures 12 and 13 show a strip port connector module 216, an upper housing 206, a housing cover recess 208, a strip guide and viewing notch 207, a strip receiving land 209, a strip delivery gap 223, a housing cover 202, a housing cover notch 235 and lower housing 232. In one example embodiment strip delivery land 209 has a convex shape and is sized and shaped to fit neatly against concave strip delivery notch 220 of PCB 211. Strip delivery gap 223 is a slightly arcuate, approximately rectangular gap opposite strip port connector 216. Strip delivery land 209 and strip delivery notch 220 of PCB 211 meet one another adjacent a lower elongate edge of strip delivery gap 223 for example. Typically, strip delivery land 209 is of approximately the same thickness as PCB 211 although this need not necessarily be the case. Thus, optionally when the meter is fully constructed there is a substantially planar, substantially continuous surface along which a strip can pass before being received into the strip port connector 216. This surface is provided by strip delivery land 209 and PCB strip delivery region 218 of PCB 211. PCB strip delivery region 218 is immediately in front of strip port connector 216 between strip port connector 216 and strip delivery notch 220 in PCB 211.

It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of at least one aspect of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

1. A meter or system or a meter or system according to any preceding claim having a housing:
a test sensor port in the housing; an upper edge in the test sensor port and a lower edge in the test sensor port wherein a test sensor can be inserted into the test sensor port between the upper and lower edges and further wherein at least one of the upper and lower edges is located inwardly of the other of the upper and lower edges towards the centre of the housing.
2. A meter or system according to any preceding claim in which the lower edge is located inwardly with respect to the upper edge in a direction towards the centre of the housing.
3. A meter or system having a housing: a test sensor port in the housing; an upper edge in the test sensor port; a lower edge in the test sensor port; and further wherein the portion of the housing leading to the upper edge in the test sensor port overlaps and extends beyond a portion of the housing leading to a lower edge of the test sensor port or vice versa.
4. A meter or system according to any preceding claim in which the test sensor port is substantially rectangular, square, oval, circular, polygonal or the like.
5. A meter or system according to any preceding claim in which an upper edge of the test sensor port has a chamfered lead-in surface.
6. A meter or system according to any preceding claim in which the chamfered lead-in surface is substantially arcuate in cross section.
7. A meter or system according to any preceding claim in which the distance by which one edge extends beyond the other is between around 0.5 and 1.5mm or between around 0.9 and 1.1mm or around 0.95mm.
PCT/GB2005/005105 2004-12-29 2005-12-29 An analyte test meter having a test sensor port WO2006070199A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US64041504P true 2004-12-29 2004-12-29
US60/640,415 2004-12-29

Publications (1)

Publication Number Publication Date
WO2006070199A1 true WO2006070199A1 (en) 2006-07-06

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9500616B2 (en) 2013-12-23 2016-11-22 Cilag Gmbh International Multi-orientation test strip
US9575051B2 (en) 2013-12-23 2017-02-21 Cilag Gmbh International Test strip connector contact protection

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5507288A (en) * 1994-05-05 1996-04-16 Boehringer Mannheim Gmbh Analytical system for monitoring a substance to be analyzed in patient-blood
WO2000007013A2 (en) * 1998-07-31 2000-02-10 Abbott Laboratories Analyte test instrument system including data management system
WO2001033214A2 (en) * 1999-10-29 2001-05-10 Roche Diagnostics Gmbh Test element analysis system with an infrared detector
US6377894B1 (en) * 1998-11-30 2002-04-23 Abbott Laboratories Analyte test instrument having improved calibration and communication processes
WO2002078512A2 (en) * 2001-04-02 2002-10-10 Therasense, Inc. Blood glucose tracking apparatus and methods
US20020170823A1 (en) * 2001-05-18 2002-11-21 Housefield T. Scott Body fluid test apparatus with detachably mounted portable tester
US20040094433A1 (en) * 2002-04-25 2004-05-20 Home Diagnostics, Inc. Systems and methods for blood glucose sensing

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5507288A (en) * 1994-05-05 1996-04-16 Boehringer Mannheim Gmbh Analytical system for monitoring a substance to be analyzed in patient-blood
US5507288B1 (en) * 1994-05-05 1997-07-08 Boehringer Mannheim Gmbh Analytical system for monitoring a substance to be analyzed in patient-blood
WO2000007013A2 (en) * 1998-07-31 2000-02-10 Abbott Laboratories Analyte test instrument system including data management system
US6377894B1 (en) * 1998-11-30 2002-04-23 Abbott Laboratories Analyte test instrument having improved calibration and communication processes
WO2001033214A2 (en) * 1999-10-29 2001-05-10 Roche Diagnostics Gmbh Test element analysis system with an infrared detector
WO2002078512A2 (en) * 2001-04-02 2002-10-10 Therasense, Inc. Blood glucose tracking apparatus and methods
US20020170823A1 (en) * 2001-05-18 2002-11-21 Housefield T. Scott Body fluid test apparatus with detachably mounted portable tester
US20040094433A1 (en) * 2002-04-25 2004-05-20 Home Diagnostics, Inc. Systems and methods for blood glucose sensing

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9500616B2 (en) 2013-12-23 2016-11-22 Cilag Gmbh International Multi-orientation test strip
US9575051B2 (en) 2013-12-23 2017-02-21 Cilag Gmbh International Test strip connector contact protection

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