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US5951492A Expired / Lapsed US ⏱️ 0.0 years remaining

Methods and apparatus for sampling and analyzing body fluid

Assignee: Roche Diabetes Care Inc
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Filing: 1997-05-16
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Granted: 1999-09-14
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Expires: 2017-05-16
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Abstract

Abstract A sampling device for sampling body fluid includes a lancet for making an incision, a capillary tube for drawing-up body fluid from the incision, and a test strip affixed to an upper end of the capillary tube for receiving the fluid. An absorbent pad can be disposed between the test strip and capillary tube for spreading-out the fluid being transferred to the test strip. An on-site analyzer such as an optical analyzer and/or an electrochemical analyzer can be mounted in the device for analyzing the fluid. Alternatively, a test strip can be slid through a slot formed in the bottom end of the device so that by passing the device against the skin after an incision has been formed, the test strip will directly contact body fluid emanating from the incision.

Inventors

  • 👤 Joel S. Douglas
  • 👤 Jeffrey N. Roe
  • 👤 Ryszard Radwanski
  • 👤 Brent G. Duchon

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-30 23:26
CPC Classifications
A; A61; A61B; A61B5/00; A61B5/15; A61B5/157; A61B10/00; A61B10/0045; A61B5/145; A61B5/14532; A61B5/150007; A61B5/150015; A61B5/150022; A61B5/150343; A61B5/150358; A61B5/150374; A61B5/150381; A61B5/150412; A61B5/151; A61B5/15101; A61B5/15103; A61B5/15107; A61B5/15109; A61B5/15115; A61B5/15117; A61B5/15186; A61B5/15188; A61B5/15192; A61B5/15194; A61B2010/0003; A61B2010/008; A61B17/00; A61B2017/00743; A61B2017/00747; A61B2017/00765; A61B2562/00; A61B2562/02; A61B2562/0295

Claims Analysis

Total Claims: 43
Claim 1
Independent Claim 145 words
A sampling device for sampling body fluid, comprising: a housing; a lancet carrier mounted in the housing and adapted for supporting a disposable lancet; a mechanism disposed in the housing for displacing the lancet carrier toward a lower end of the housing for forming an incision through the skin of a user; a body fluid sampling member mounted in the housing for conducting body fluid from the incision, comprising a capillary member including an elongated stem having a capillary passage extending longitudinally therethrough for conducting body fluid upwardly by capillary action, and a test strip affixed to the capillary member at an upper end thereof and in communication with the capillary passage for receiving a sample of body fluid therefrom; and a drop detecting mechanism disposed adjacent a lower end of the device for detecting a drop of body fluid disposed on the user's skin.
Claim 2
Dependent Claim 145 words
A sampling device for sampling body fluid, comprising: a housing; a lancet carrier mounted in the housing and adapted for supporting a disposable lancet; a mechanism disposed in the housing for displacing the lancet carrier toward a lower end of the housing for forming an incision through the skin of a user; a body fluid sampling member mounted in the housing for conducting body fluid from the incision, comprising a capillary member including an elongated stem having a capillary passage extending longitudinally therethrough for conducting body fluid upwardly by capillary action, and a test strip affixed to the capillary member at an upper end thereof and in communication with the capillary passage for receiving a sample of body fluid therefrom; and a drop detecting mechanism disposed adjacent a lower end of the device for detecting a drop of body fluid disposed on the user's skin.
Claim 3
Dependent Claim 15 words
The sampling device according to claim 1 wherein the test strip comprises a microporous membrane.
Claim 4
Dependent Claim 40 words
The sampling device according to claim 1 wherein the sampling member further comprises an absorbent pad disposed between the test strip and the upper end of the capillary passage for wicking body fluid from the passage to the test strip.
Claim 5
Dependent Claim 27 words
The sampling device according to claim 3 wherein the pad is affixed directly to the capillary member, and the test strip is affixed directly to the pad.
Claim 6
Dependent Claim 22 words
The sampling device according to claim 1 wherein the disposable element includes a body, the sampling member being mounted in the body.
Claim 7
Dependent Claim 30 words
The sampling device according to claim 5 wherein the sampling member is slidable relative to the body, the housing including a manually actuable pusher for pushing the sampling member downwardly.
Claim 8
Dependent Claim 28 words
The sampling device according to claim 6, further including an optical analyzing mechanism disposed in the housing and arranged to analyze body fluid disposed on the test strip.
Claim 9
Dependent Claim 38 words
The sample device according to claim 7 wherein the optical analyzing mechanism comprises a light emitter for directing light toward body fluid disposed on the test strip, and a light receiver for receiving light reflected off the sample.
Claim 10
Dependent Claim 45 words
The sampling device according to claim 6, further including an electrochemical analyzing mechanism mounted in the housing, the pusher carrying electrical leads arranged for making electrical connection with a body fluid sample on the test strip, the leads being electrically connected to the analyzing mechanism.
Claim 11
Dependent Claim 37 words
The sampling device according to claim 1, further including an electrochemical analyzing meter mounted in the housing, a manually movable element mounted in the housing and carrying electrical leads arranged to make electrical connection with the meter.
Claim 12
Dependent Claim 31 words
The sampling device according to claim 1 wherein the drop detecting mechanism includes a pair of spaced apart electrodes arranged to contact the drop and provide a signal to an indicator.
Claim 13
Dependent Claim 34 words
The sampling device according to claim 1 wherein the drop detecting mechanism comprises a light emitter and light receiver disposed adjacent a lower end of the device and provide a signal to an indicator.
Claim 14
Dependent Claim 139 words
A sampling device for sampling body fluid, comprising: a housing; a lancet carrier mounted in the housing and adapted for supporting a disposable lancet; a mechanism for displacing the lancet carrier toward a lower end of the housing for forming an incision through the skin of a user; and a strip-holding mechanism mounted at a lower end of the housing for supporting a test strip across the lower end of the housing to enable the test strip to pick-up body fluid from the incision, the strip-holding mechanism comprises at least one sleeve surrounding the lancet carrier and including slots for receiving the test strip, said at least one sleeve being longitudinally slidable relative to said housing such that by pushing down on said housing body one or more times fluid is expressed through an incision formed by said lancet.
Claim 15
Dependent Claim 139 words
A sampling device for sampling body fluid, comprising: a housing; a lancet carrier mounted in the housing and adapted for supporting a disposable lancet; a mechanism for displacing the lancet carrier toward a lower end of the housing for forming an incision through the skin of a user; and a strip-holding mechanism mounted at a lower end of the housing for supporting a test strip across the lower end of the housing to enable the test strip to pick-up body fluid from the incision, the strip-holding mechanism comprises at least one sleeve surrounding the lancet carrier and including slots for receiving the test strip, said at least one sleeve being longitudinally slidable relative to said housing such that by pushing down on said housing body one or more times fluid is expressed through an incision formed by said lancet.
Claim 16
Dependent Claim 96 words
The sampling device according to claim 13 wherein the sleeve constitutes a first sleeve, the strip-holding mechanism further including a second sleeve surrounding the first sleeve and including slots radially aligned with the slots of the first sleeve, the second sleeve being slidable longitudinally relative to both the housing and the first sleeve and being spring biased downwardly, the slots formed in the second sleeve being elongated in a direction parallel to a longitudinal axis of the housing to enable the second sleeve to move longitudinally relative to a test strip mounted in the first sleeve.
Claim 17
Dependent Claim 48 words
A sampling device for sampling body fluid, comprising: a housing; means in the housing for forming an incision through the skin of a user; and a drop-detecting mechanism disposed adjacent a lower end of the device for detecting a drop of body fluid disposed on the user's skin.
Claim 18
Dependent Claim 48 words
A sampling device for sampling body fluid, comprising: a housing; means in the housing for forming an incision through the skin of a user; and a drop-detecting mechanism disposed adjacent a lower end of the device for detecting a drop of body fluid disposed on the user's skin.
Claim 19
Dependent Claim 36 words
The sampling device according to claim 15, further including an indicator mounted on the housing and connected to the drop-detecting mechanism for providing an indication to a user when a detected drop is of predetermined size.
Claim 20
Dependent Claim 24 words
The sampling device according to claim 15 wherein the drop detecting mechanism includes a pair of spaced apart electrodes arranged to contact the drop.
Claim 21
Dependent Claim 27 words
The sampling device according to claim 15 wherein the drop detecting mechanism comprises a light emitter and light receiver disposed adjacent a lower end of the device.
Claim 22
Dependent Claim 96 words
A body fluid sampling member adapted to be mounted in a device for sampling body fluid, comprising: a capillary member including an elongated stem having a capillary passage extending longitudinally therethrough and constructed such that said passage conducts body fluid upwardly by capillary action without the assistance of a vacuum applied from outside said passage, said capillary member further including an upper end having an enlarged head portion; and a test strip affixed to the capillary member at the upper end thereof and in communication with the capillary passage for receiving a sample of body fluid.
Claim 23
Dependent Claim 96 words
A body fluid sampling member adapted to be mounted in a device for sampling body fluid, comprising: a capillary member including an elongated stem having a capillary passage extending longitudinally therethrough and constructed such that said passage conducts body fluid upwardly by capillary action without the assistance of a vacuum applied from outside said passage, said capillary member further including an upper end having an enlarged head portion; and a test strip affixed to the capillary member at the upper end thereof and in communication with the capillary passage for receiving a sample of body fluid.
Claim 24
Dependent Claim 17 words
The body fluid sampling member according to claim 19 wherein the test strip comprises a microporous membrane.
Claim 25
Dependent Claim 44 words
The body fluid sampling member according to claim 20 further comprising an absorbent pad disposed between the test strip and the upper end of the capillary member and arranged over the capillary passage for wicking body fluid from the passage to the test strip.
Claim 26
Dependent Claim 31 words
The body fluid sampling member according to claim 21 wherein the absorbent pad is affixed directly to the capillary member, and the test strip is affixed directly to the absorbent pad.
Claim 27
Dependent Claim 45 words
The body fluid sampling member according to claim 21 further including a covering structure covering portions of the absorbent pad not covered by the membrane; the covering structure being vented by at least one air vent opening having a smaller cross section than the passage.
Claim 28
Dependent Claim 37 words
The body fluid sampling member according to claim 23 wherein the covering structure includes a flange projecting laterally outwardly from an upper end of the stem, a lower surface of the pad being seated on the flange.
Claim 29
Dependent Claim 26 words
The body fluid sampling member according to claim 24 wherein the covering structure further includes a side cover extending around a side surface of the pad.
Claim 30
Dependent Claim 19 words
the body fluid sampling member according to claim 25 wherein the air vent opening is disposed in the flange.
Claim 31
Dependent Claim 139 words
A sampling device for sampling body fluid, comprising: a housing; a disposable lancet; a mechanism disposed in the housing for displacing the lancet toward a lower end of the housing for forming an incision through the skin of a user; a body fluid sampling member mounted in the housing for conducting body fluid from the incision, comprising a capillary member including an elongated stem having a capillary passage extending longitudinally therethrough for conducting body fluid upwardly by capillary action, and a test strip affixed to the capillary member at an upper end thereof and in communication with the capillary passage for receiving a sample of body fluid therefrom; a body disposed within said housing, said lancet and said capillary member being carried by said body; and a pusher member for pushing the capillary member downwardly relative to said body.
Claim 32
Dependent Claim 139 words
A sampling device for sampling body fluid, comprising: a housing; a disposable lancet; a mechanism disposed in the housing for displacing the lancet toward a lower end of the housing for forming an incision through the skin of a user; a body fluid sampling member mounted in the housing for conducting body fluid from the incision, comprising a capillary member including an elongated stem having a capillary passage extending longitudinally therethrough for conducting body fluid upwardly by capillary action, and a test strip affixed to the capillary member at an upper end thereof and in communication with the capillary passage for receiving a sample of body fluid therefrom; a body disposed within said housing, said lancet and said capillary member being carried by said body; and a pusher member for pushing the capillary member downwardly relative to said body.
Claim 33
Dependent Claim 28 words
The sampling device according to claim 27, further including an optical analyzing mechanism disposed in the housing and arranged to analyze body fluid disposed on the test strip.
Claim 34
Dependent Claim 45 words
The sampling device according to claim 27, further including an electrochemical analyzing mechanism mounted in the housing, the pusher carrying electrical leads arranged for making electrical connection with a body fluid sample on the test strip, the leads being electrically connected to the analyzing mechanism.
Claim 35
Dependent Claim 37 words
The sampling device according to claim 27, further including an electrochemical analyzing meter mounted in the housing, a manually movable element mounted in the housing and carrying electrical leads arranged to make electrical connection with the meter.
Claim 36
Dependent Claim 33 words
The sampling device according to claim 27, further including a drop detecting mechanism disposed adjacent a lower end of the device for detecting a drop of body fluid disposed on the user's skin.
Claim 37
Dependent Claim 15 words
The sampling device according to claim 27, wherein the test strip comprises a microporous membrane.
Claim 38
Dependent Claim 42 words
The sampling device according to claim 32, further comprising an absorbent pad disposed between the test strip and the upper end of the capillary member and arranged over the capillary passage for wicking body fluid from the passage to the test strip.
Claim 39
Dependent Claim 29 words
The sampling device according to claim 33, wherein the absorbent pad is affixed directly to the capillary member, and the test strip is affixed directly to the absorbent pad.
Claim 40
Dependent Claim 43 words
The sampling device according to claim 33, further including a covering structure covering portions of the absorbent pad not covered by the membrane; the covering structure being vented by at least one air vent opening having a smaller cross section than the passage.
Claim 41
Dependent Claim 35 words
The sampling device according to claim 35, wherein the covering structure includes a flange projecting laterally outwardly from an upper end of the stem, a lower surface of the pad being seated on the flange.
Claim 42
Dependent Claim 24 words
The sampling device according to claim 36, wherein the covering structure further includes a side cover extending around a side surface of the pad.
Claim 43
Dependent Claim 17 words
The sampling device according to claim 37, wherein the air vent opening is disposed in the flange.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2002-09-13 2003-03-15 2003-09-14 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2006-09-13 2007-03-15 2007-09-14 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2010-09-13 2011-03-15 2011-09-14 $7700.00 Window Closed / Lapsed

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