Methods and apparatus for sampling and analyzing body fluid

• US 5,951,492 A
• Filed: 05/16/1997
• Issued: 09/14/1999
• Est. Priority Date: 05/17/1996
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Mercury Diagnostics, Inc.
• Inventors: Duchon, Brent G., Roe, Jeffrey N., Radwanski, Ryszard, Douglas, Joel S.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US08/858,042
• Time in Patent Office: 851 Days
• Field of Search: 600/573, 600/576, 600/583, 600/584, 606/181, 606/182
• US Class Current: 600/583
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2010/0003 including means for analysis by an unskilled person
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 2017/00765 Decreasing the barrier function of skin tissue by radiated energy, e.g. using ultrasound, using laser for skin perforation
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/15109 Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

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.

Claims

1. 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.

2. The sampling device according to claim 1 wherein the test strip comprises a microporous membrane.

3. 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.

4. 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.

5. The sampling device according to claim 1 wherein the disposable element includes a body, the sampling member being mounted in the body.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

17. The sampling device according to claim 15 wherein the drop detecting mechanism includes a pair of spaced apart electrodes arranged to contact the drop.

18. 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.

19. 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.

20. The body fluid sampling member according to claim 19 wherein the test strip comprises a microporous membrane.

21. 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.

22. 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.

23. 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.

24. 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.

25. 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.

26. the body fluid sampling member according to claim 25 wherein the air vent opening is disposed in the flange.

27. 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.

28. 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.

29. 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.

30. 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.

31. 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.

32. The sampling device according to claim 27, wherein the test strip comprises a microporous membrane.

33. 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.

34. 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.

35. 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.

36. 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.

37. The sampling device according to claim 36, wherein the covering structure further includes a side cover extending around a side surface of the pad.

38. The sampling device according to claim 37, wherein the air vent opening is disposed in the flange.