Integrated disposable for automatic or manual blood dosing

• US 20050251064A1
• Filed: 05/07/2004
• Published: 11/10/2005
• 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 7,322,942 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
• 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; and

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.

2. The device of claim 1, further comprising an incision forming member extending proximal to said first opening for forming an incision.

3. The device of claim 2, 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 lancet with a blade that extends from said first opening, said second opening being defined in said lancet;

at least two spacers on said lancet defining opposite sides of said channel; and

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 lancet with a blade that extends from said first opening;

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; and

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.

14. A method, comprising:

drawing body fluid into a first opening of a 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.

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

16. The method of claim 14, further comprising:

forming an incision with a blade that extends proximal to the first opening of the sampling device; and

wherein said drawing includes drawing the body fluid from the incision.

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.

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.

22. An integrated sampling device, comprising:

means for forming an incision in skin;

means for collecting body fluid automatically from the incision;

means for collecting the body fluid manually from the incision upon failure to collect the body fluid automatically; and

means for analyzing the body fluid that is collected.

23. The device of claim 22, wherein:

said means for forming the incision in the skin includes a lancet;

said means for collecting the body fluid automatically from the incision includes a first opening positioned proximal to said lancet;

said means for collecting body fluid manually from the incision upon failure to collect the body fluid automatically includes a second opening disposed near said means for analyzing the body fluid that is collected; and

said means for analyzing the body fluid that is collected includes a test strip.

24. The device of claim 23, wherein said second opening is defined in said lancet.

25. The device of claim 23, further comprising a spacer that defines said second opening.

26. The device of claim 23, wherein said means for collecting the body fluid automatically from the incision further includes a collection sheet extending from the first opening to draw fluid into the first opening.