Integrated disposable for automatic or manual blood dosing

• US 7,670,301 B2
• Filed: 12/05/2007
• Issued: 03/02/2010
• Est. Priority Date: 05/07/2004
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Jeffrey N.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): NGUYEN, HUONG Q
• Application Number:
  US11/950,457
• Publication Number:
  US 20080161724A1
• Time in Patent Office: 818 Days
• Field of Search: 600/583, 600/584, 600/573, 606/181, 606/182
• 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;

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

wherein said at least two spacers are sandwiched between said lancet and said test media;

wherein said test media covers one side of said second opening so that said second opening opens along said lateral side of said channel at said test media;

said sampling portion defining a vent opening at an end of the channel that is opposite the first opening; and

the first opening, the second opening, and the vent opening are separate and distinct from one another.

2. 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.

3. The device of claim 2, wherein said hydrophilic sheet at the first opening has a trapezoidal shape.

4. 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.

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

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

7. 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.

8. The device of claim 7, wherein said collection sheet is transparent to allow determination of sufficiency of the body fluid in said channel.

9. The device of claim 7, wherein said channel is sized to draw the body fluid via capillary action.

10. The device of claim 1, wherein said second opening has tapered sides to minimize dose hesitation.

11. 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.

12. The method of claim 11, further comprising testing the body fluid with the test media.

13. The method of claim 11, further comprising expressing the body fluid from the incision before said collecting.

14. The method of claim 13, wherein said expressing includes pressing the sampling device against the skin.

15. The method of claim 11, wherein said drawing includes drawing the body fluid into the channel via capillary action.

16. The method of claim 11, wherein said determining includes visually determining that the body fluid drawn into the first opening is insufficient.

17. The method of claim 11, wherein said determining includes automatically determining that the body fluid drawn into the first opening is insufficient with a sensor in the sampling device.

18. The method of claim 11, further comprising:

wherein the sampling device has opposing lateral side edges; and

wherein the second opening opens at one of the lateral side edges.

19. 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;

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;

wherein said sampling portion defines a vent opening at an end of the channel that is opposite the first opening; and

wherein the first opening, the second opening and the vent opening are separate and distinct from one another.

20. The device of claim 19, further comprising a hydrophilic sheet extending proximal to said first opening for drawing the body fluid into said first opening.

21. The device of claim 20, wherein said hydrophilic sheet at the first opening has a trapezoidal shape.

22. The device of claim 20, wherein said hydrophilic sheet is transparent to allow determination of sufficiency of the body fluid in said channel.

23. The device of claim 19, wherein said second opening has tapered sides to minimize dose hesitation.

24. The device of claim 19, further comprising:

wherein said at least two spacers are sandwiched between said lancet and said test media; and

wherein said test media defines one side of said second opening so that said second opening opens along said channel at said test media.