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US20020110486A1 - Analyte test strip with two controls - Google Patents

Analyte test strip with two controls
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Publication number
US20020110486A1
US20020110486A1US10/121,636US12163602AUS2002110486A1US 20020110486 A1US20020110486 A1US 20020110486A1US 12163602 AUS12163602 AUS 12163602AUS 2002110486 A1US2002110486 A1US 2002110486A1
Authority
US
United States
Prior art keywords
measurement area
sample
channel
bladder
layer
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US10/121,636
Inventor
Robert Shartle
Herbert Chow
Christa Hartmann
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
LifeScan Inc
Original Assignee
LifeScan Inc
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 IncfiledCriticalLifeScan Inc
Priority to US10/121,636priorityCriticalpatent/US20020110486A1/en
Assigned to LIFESCAN, INC.reassignmentLIFESCAN, INC.ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS).Assignors: SHARTLE, ROBERT JUSTICE, CHOW, HERBERT, HARTMANN, CHRISTA
Publication of US20020110486A1publicationCriticalpatent/US20020110486A1/en
Abandonedlegal-statusCriticalCurrent

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Abstract

A fluidic medical diagnostic device permits measurement of analyte concentration or a property of a biological fluid, particularly the coagulation time of blood. The device has at one-end a sample port for introducing a sample and at the other end a bladder for drawing the sample to a measurement area. A channel carries the sample from the sample port to the measurement area, and a stop junction, between the measurement area and bladder, halts the sample flow. The desired measurement can be made by placing the device into a meter which measures a physical property of the sample—typically, optical transmittance—after it has interacted with a reagent in the measurement area.

Description

Claims (21)

We claim:
1. A fluidic diagnostic device for measuring an analyte concentration or property of a biological fluid, comprising
a first layer and second layer, at least one of which has a resilient region over at least a part of its area, separated by an intermediate layer, in which cutouts in the intermediate layer form, with the first and second go layers,
a) a sample port for introducing a sample of the biological fluid into the device;
b) a first measurement area, in which a physical parameter of the sample is measured and related to the analyte concentration or property of the fluid;
c) a first channel, having a first end and a second end, to provide a fluidic path from the sample port at the first end through the first measurement area;
d) a first bladder, at the second end of the first channel, comprising at least a part of the resilient region in at least the first or second layer and having a volume that is at least about equal to the combined volume of the first measurement area and first channel; and
e) a first stop junction in the first channel between the first measurement area and first bladder that comprises a co-aligned through hole in the first or second layer, the through hole overlaid with a third layer.
2. The device ofclaim 1 in which the sample port comprises co-aligned through holes in the first and intermediate layers.
3. The device ofclaim 1 in which the first stop junction further comprises a second through hole aligned with the first through hole, the second through hole being overlaid with a fourth layer.
4. The device ofclaim 1, further comprising a bypass channel, to provide an additional path from the first channel to the bladder, without traversing the first measurement area and first stop junction.
5. The device ofclaim 1 in which at least the first or second layer is substantially transparent adjoining the first measurement area, and the physical parameter that is measured is optical transmission.
6. The device ofclaim 5 further comprising a reflective surface adjoining the first measurement area.
7. The device ofclaim 1 in which the physical parameter of the sample undergoes a change in the measurement area.
8. The device ofclaim 7 in which the first measurement area contains a composition that facilitates blood clotting, the biological fluid is whole blood, and the property being measured is prothrombin time.
9. The device ofclaim 8 in which the composition comprises thromboplastin.
10. The device ofclaim 1 further comprising a filter adjoining the sample port for filtering the biological fluid being introduced into the sample port.
11. The device ofclaim 10 in which the filter comprises an anisotropic membrane.
12. The device ofclaim 11 in which the filter material is polysulfone.
13. The device ofclaim 1 further comprising at least one additional measurement area between the first measurement area and the stop junction.
14. The device ofclaim 1 further comprising at least one alternate fluidic path from the first channel to the bladder, each such alternate path including a corresponding measurement area and stop junction.
15. The device ofclaim 4 in which the first measurement area contains a composition that facilitates blood. clotting, the biological fluid is whole blood, and the property being measured is prothrombin time.
16. The device ofclaim 15 further comprising at least one alternate fluidic path from the first channel to the bladder, each such alternate path including a corresponding measurement area and stop junction.
17. The device ofclaim 16 in which a first alternate path is to a measurement area that overcomes the effect of an anticoagulant and a second alternate path is to a measurement area that partially overcomes the effect of an anticoagulant.
18. The device ofclaim 17 in which the measurement area in the first alternate path comprises thromboplastin, bovine eluate, and recombinant Factor VIIa and the measurement area in the second alternate path comprises thromboplastin and bovine eluate.
19. The device ofclaim 13 further comprising at least one set of channel, measurement area, and stop junction between the first stop junction and first bladder and, adjoining the first bladder, an additional bladder for each such set.
20. The device ofclaim 19 further comprising a bypass channel from the first channel to the first bladder and an additional bypass channel from the channel of each additional set to the corresponding additional bladder.
21. A fluidic diagnostic device for measuring an analyte concentration or property of a biological fluid, comprising
a first layer, which has a resilient region over at least a part of its area, and a second layer, separated by an intermediate layer, in which recesses in a first surface of the intermediate layer form, with the first layer,
a) a sample port for introducing a sample of the biological fluid into the device;
b) a measurement area, in which the sample undergoes a change in a physical property that is to measured and related to the analyte concentration or property of the fluid;
c) a channel, having a first end and a second end, to provide a fluidic path from the sample port at the first end through the measurement area; and
d) a bladder, at the second end of the channel, comprising the resilient region in the first layer and having a volume that is at least about equal to the combined volume of the measurement area and channel; and
a stop junction in the channel between the measurement area and bladder that comprises two passages substantially normal to the first surface of the intermediate layer, each passage having a first end in fluid communication with the channel and a second end in fluid communication with a recess in a second surface of the intermediate layer, which recess provides fluid communication between the second ends of the passages.
US10/121,6361998-07-202002-04-11Analyte test strip with two controlsAbandonedUS20020110486A1 (en)

Priority Applications (1)

Application NumberPriority DateFiling DateTitle
US10/121,636US20020110486A1 (en)1998-07-202002-04-11Analyte test strip with two controls

Applications Claiming Priority (3)

Application NumberPriority DateFiling DateTitle
US9342198P1998-07-201998-07-20
US09/333,765US6521182B1 (en)1998-07-201999-06-15Fluidic device for medical diagnostics
US10/121,636US20020110486A1 (en)1998-07-202002-04-11Analyte test strip with two controls

Related Parent Applications (1)

Application NumberTitlePriority DateFiling Date
US09/333,765ContinuationUS6521182B1 (en)1998-07-201999-06-15Fluidic device for medical diagnostics

Publications (1)

Publication NumberPublication Date
US20020110486A1true US20020110486A1 (en)2002-08-15

Family

ID=26787520

Family Applications (8)

Application NumberTitlePriority DateFiling Date
US09/333,765Expired - LifetimeUS6521182B1 (en)1998-07-201999-06-15Fluidic device for medical diagnostics
US10/052,447AbandonedUS20020064480A1 (en)1998-07-202002-01-17Fluidic device for medical diagnostics
US10/121,636AbandonedUS20020110486A1 (en)1998-07-202002-04-11Analyte test strip with two controls
US10/121,425AbandonedUS20020110922A1 (en)1998-07-202002-04-11Vacuum loaded test strip and method of use
US10/264,662AbandonedUS20030031594A1 (en)1998-07-202002-10-03Vacuum loaded test strip with stop junction and bypass channel
US10/330,790Expired - LifetimeUS7022286B2 (en)1998-07-202002-12-26Fluidic device for medical diagnostics
US10/330,456AbandonedUS20030156983A1 (en)1998-07-202002-12-26Fluidic device for medical diagnostics
US10/666,846AbandonedUS20040109790A1 (en)1998-07-202003-09-18Vacuum loaded test strip with stop junction and bypass channel

Family Applications Before (2)

Application NumberTitlePriority DateFiling Date
US09/333,765Expired - LifetimeUS6521182B1 (en)1998-07-201999-06-15Fluidic device for medical diagnostics
US10/052,447AbandonedUS20020064480A1 (en)1998-07-202002-01-17Fluidic device for medical diagnostics

Family Applications After (5)

Application NumberTitlePriority DateFiling Date
US10/121,425AbandonedUS20020110922A1 (en)1998-07-202002-04-11Vacuum loaded test strip and method of use
US10/264,662AbandonedUS20030031594A1 (en)1998-07-202002-10-03Vacuum loaded test strip with stop junction and bypass channel
US10/330,790Expired - LifetimeUS7022286B2 (en)1998-07-202002-12-26Fluidic device for medical diagnostics
US10/330,456AbandonedUS20030156983A1 (en)1998-07-202002-12-26Fluidic device for medical diagnostics
US10/666,846AbandonedUS20040109790A1 (en)1998-07-202003-09-18Vacuum loaded test strip with stop junction and bypass channel

Country Status (13)

CountryLink
US (8)US6521182B1 (en)
EP (1)EP0974840B1 (en)
JP (1)JP2000055911A (en)
KR (1)KR100634714B1 (en)
CN (1)CN1199038C (en)
AT (1)ATE229649T1 (en)
CA (1)CA2277639A1 (en)
DE (1)DE69904403T2 (en)
DK (1)DK0974840T3 (en)
ES (1)ES2189353T3 (en)
IL (1)IL130807A (en)
NO (1)NO993536L (en)
TW (1)TW411268B (en)

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IL130807A0 (en)2001-01-28
US20030156983A1 (en)2003-08-21
KR20000011826A (en)2000-02-25
EP0974840A2 (en)2000-01-26
US20020064480A1 (en)2002-05-30
US7022286B2 (en)2006-04-04
ATE229649T1 (en)2002-12-15
DE69904403D1 (en)2003-01-23
CA2277639A1 (en)2000-01-20
US20030156984A1 (en)2003-08-21
NO993536L (en)2000-01-21
NO993536D0 (en)1999-07-19
EP0974840A3 (en)2000-03-08
CN1250160A (en)2000-04-12
DK0974840T3 (en)2003-03-31
CN1199038C (en)2005-04-27
KR100634714B1 (en)2006-10-17
US20040109790A1 (en)2004-06-10
IL130807A (en)2003-11-23
ES2189353T3 (en)2003-07-01
JP2000055911A (en)2000-02-25
US20020110922A1 (en)2002-08-15
TW411268B (en)2000-11-11
EP0974840B1 (en)2002-12-11
DE69904403T2 (en)2003-10-30
US20030031594A1 (en)2003-02-13
US6521182B1 (en)2003-02-18

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