INTEGRATED DISPOSABLE FOR AUTOMATIC OR MANUAL BLOOD DOSING

• US 20080161724A1
• Filed: 12/05/2007
• Published: 07/03/2008
• Est. Priority Date: 05/07/2004
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Jeffrey N.
• Granted Patent: US 7,670,301 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 5/150213 Venting means
• 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 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• CPC Class Codes: A61B 5/150534 Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable

Abstract

An integrated sampling device defines a first opening and a second opening. The first opening is connected to a channel for drawing fluid automatically towards a test media upon incision by an incision portion. The second opening is positioned over the test media allowing manual sampling of fluid if the channel fails to draw a sufficient amount of fluid onto the test media.

Claims

1. An integrated sampling device for analyzing body fluid, comprising:

a sampling portion defining a channel with a first opening;

a test media positioned along said channel for analyzing the body fluid;

wherein said sampling portion defines a second opening that is positioned closer to said test media than said first opening for dosing the body fluid onto said test media via said second opening when dosing of the body fluid via said first opening is unsuccessful;

a lancet with a blade that extends from said first opening; and

at least two spacers on said lancet defining opposite sides of said channel, wherein said second opening is defined in at least one of said two spacers.

3. The device of claim 1, further comprising a hydrophilic sheet extending proximal to said first opening for drawing the body fluid into said first opening.

4. The device of claim 1, wherein said second opening opens partially over said test media.

5. The device of claim 1, wherein said second opening opens directly over said test media.

6. The device of claim 1, wherein said second opening opens to the side of said test media.

7. The device of claim 1, further comprising a collection sheet extending proximal to said first opening for drawing the body fluid into said first opening.

8. The device of claim 1, wherein said sampling portion is generally flat.

9. The device of claim 1, wherein said sampling portion and said test media are incorporated into a cassette.

10. The device of claim 1, wherein said sampling portion includes:

a collection sheet covering said two spacers, said collection sheet having a portion extending from said first opening for drawing fluid into said first opening.

11. The device of claim 10, wherein said collection sheet is transparent to allow determination of sufficiency of the body fluid in said channel.

12. The device of claim 10, wherein said channel is sized to draw the body fluid via capillary action.

13. The device of claim 1, wherein said sampling portion includes:

a collection sheet covering said two spacers, said collection sheet having a portion extending from said first opening for drawing fluid into said first opening.

27. The device of claim 1, wherein said sampling portion defines a vent at an end of the channel that is opposite the first opening.

2. (canceled)

14. A method, comprising:

forming an incision with a blade that extends from a sampling device;

drawing body fluid from the incision into a first opening of the sampling device, wherein the sampling device includes a channel to transport the body fluid onto test media;

determining that the body fluid drawn into the first opening is insufficient; and

collecting the body fluid with a second opening of the sampling device that is positioned closer to the test media than the first opening, wherein the second opening is defined in a spacer located on one side of the sampling device, wherein said collecting includes facing the one side of the sampling device with the second opening towards the incision.

15. The method of claim 14, further comprising testing the body fluid with the test media.

19. The method of claim 14, wherein said drawing includes drawing the body fluid into the channel via capillary action.

20. The method of claim 14, wherein said determining includes visually determining that the body fluid drawn into the first opening is insufficient.

21. The method of claim 14, wherein said determining includes automatically determining that the body fluid drawn into the first opening is insufficient with a sensor in the sampling device.

16. (canceled)

17. The method of claim 16, further comprising expressing the body fluid from the incision before said collecting.

18. The method of claim 17, wherein said expressing includes pressing the sampling device against the skin.

22-26. -26. (canceled)

28. A method, comprising:

securing at least two spacers to a lancet to at least in part define a capillary channel with a first opening for collecting body fluid;

securing test media along the capillary channel; and

forming a second opening for collecting body fluid with the at least two spacers.

29. The method of claim 28, further comprising:

forming a vent opening with the spacers at an end of the capillary channel that is opposite the first opening.

30. The method of claim 28, further comprising:

securing a fluid collection sheet to the at least two spacers.

31. The method of claim 28, in which said securing the at least two spacers includes fixing the at least two spacers to the lancet with adhesive.