Integrated disposable for automatic or manual blood dosing

• US 8,636,674 B2
• Filed: 01/13/2010
• Issued: 01/28/2014
• 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.
• Primary Examiner(s): Szmal, Brian
• Assistant Examiner(s): NGUYEN, HUONG Q
• Application Number:
  US12/686,716
• Publication Number:
  US 20100113977A1
• Time in Patent Office: 1,476 Days
• Field of Search: 600/583, 600/584, 600/573, 600/576, 606181-183
• 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. A method, comprising:

creating a capillary channel along a lancet, wherein the capillary channel has a first opening for collecting body fluid and a vent opening at an end of the capillary channel that is opposite the first opening, wherein the capillary channel fluidly connects the first opening to the vent opening;

positioning a test media along the capillary channel between the first opening and the vent opening;

forming a second opening along the capillary between the first opening and the vent opening, wherein the second opening is located closer to the test media than the first opening, wherein the first opening, the second opening, and the vent opening are separate and distinct from one another;

wherein said forming the second opening includes forming the second opening in the lancet; and

wherein said forming the second opening in the lancet includes locating the second opening directly over the test media in which the second opening faces the test media.

2. The method of claim 1, wherein said forming the second opening in the lancet includes machining the second opening in the lancet.

3. The method of claim 1, wherein said forming the second opening in the lancet includes photo-etching the second opening in the lancet.

4. The method of claim 1, wherein said creating the capillary channel includes covering the capillary channel with a hydrophilic fluid collection sheet that extends from the first opening.

5. A method, comprising:

forming an opening in a lancet;

securing the lancet to a test media with the opening in the lancet being positioned directly over the test media, wherein the test media and the lancet are sandwiched together so that the opening faces the test media during said securing, wherein the opening is configured to allow body fluid to be directly deposited onto the test media;

wherein the lancet has a blade for forming an incision;

creating a capillary channel along the lancet, wherein the capillary channel has a fluid collection opening for collecting body fluid, wherein the fluid collection opening is located at the blade;

wherein said creating the capillary channel includes securing at least two spacers to the lancet to at least define in part the capillary channel; and

wherein said securing the lancet to the test media includes securing the lancet to the spacers in which the opening in the lancet is spaced apart from the test media by the spacers.

6. The method of claim 5, wherein said forming the opening in the lancet includes machining the opening in the lancet.

7. The method of claim 5, wherein said forming the opening in the lancet includes photo-etching the opening in the lancet.

8. The method of claim 5, further comprising:

wherein the lancet has a blade for forming an incision; and

creating a capillary channel along a lancet, wherein the capillary channel has a fluid collection opening for collecting body fluid, wherein the fluid collection opening is located at the blade.

9. The method of claim 8, wherein said creating the capillary channel includes covering the capillary channel with a hydrophilic fluid collection sheet that extends from the fluid collection opening of the capillary channel.

10. The method of claim 8, wherein said creating the capillary channel includes creating a vent opening at an end of the capillary channel that is opposite the fluid collection opening.

11. The method of claim 8, further comprising:

wherein the lancet and the test media form an integrated device; and

coupling multiple integrated devices to form a belt of the integrated devices.

12. The method of claim 11, wherein said coupling the multiple integrated devices includes coupling the integrated devices together with a flexible tape.

13. The method of claim 11, further comprising:

storing the belt of the integrated devices in a reel-to-reel type cassette.

14. A method, comprising:

penetrating skin with a lancet to form an incision, wherein the lancet is secured to a test media to form an integrated device, wherein the lancet has an opening directly positioned over the test media, wherein the test media has a sample application surface that faces the opening in the lancet, wherein the integrated device has a capillary channel that extends along the length of the lancet, wherein the opening in the lancet and the sample application surface are located on opposite sides of the capillary channel;

collecting body fluid from the incision by drawing the body fluid into the capillary channel of the integrated device;

determining an insufficient volume of fluid was collected in the capillary channel;

positioning the incision in the skin at the opening in the lancet;

depositing the body fluid from the incision directly onto the sample application surface of the test media through the opening in the lancet; and

wherein said collecting and said determining occur before said depositing the body fluid.

15. The method of claim 14, wherein said collecting the body fluid includes drawing the body fluid into the capillary channel with a fluid collection sheet that extends from the integrated device.

16. The method of claim 15, wherein said determining includes detecting the insufficient volume with electrodes in the capillary channel.

17. The method of claim 15, wherein said determining includes visually detecting the insufficient volume.

18. The method of claim 14, wherein said penetrating the skin includes firing the lancet with a body fluid sampling device.

19. The method of claim 14, further comprising:

analyzing the body fluid with the test media.

20. An apparatus, comprising:

an integrated device including

a lancet having an opening, the lancet having a body portion and a blade portion extending from the body portion, wherein the opening is defined in the body portion, the lancet having the blade for forming an incision, the lancet defining one side of a capillary channel that extends along the length of the lancet,

spacers defining opposing sides of the capillary channel,

the capillary channel having a fluid collection opening for collecting body fluid from the incision, wherein the fluid collection opening is located at the blade,

a test media secured to the lancet via the spacers, wherein the test media and the lancet are disposed along opposite sides of the capillary channel, and

wherein the opening in the lancet is positioned directly over the test media, wherein the opening in the lancet is configured to allow body fluid to be directly deposited onto the test media.

21. The apparatus of claim 20, further comprising:

the lancet having a blade for forming an incision;

the integrated device including a capillary channel that extends along a lancet; and

the capillary channel having a fluid collection opening for collecting body fluid from the incision, wherein the fluid collection opening is located at the blade.

22. The apparatus of claim 21, further comprising:

a hydrophilic fluid collection sheet extending from the fluid collection opening of the capillary channel.

23. The apparatus of claim 20, wherein the opening has a circular shape.

24. The apparatus of claim 20, wherein the lancet is fixed in position with respect to the integrated device.

25. The apparatus of claim 20, wherein the lancet is moveable with respect to the integrated device.

26. The apparatus of claim 20, further comprising:

a body fluid sampling device in which the integrated device is installed, the body fluid sampling device being configured to fire the integrated device to form an incision.

27. The apparatus of claim 20, further comprising:

the lancet having a blade for forming an incision; and

a protective cap covering the blade.

28. The apparatus of claim 20, wherein the lancet includes a connection loop defining a registration opening for securing the integrated device.

29. The apparatus of claim 28, wherein the connection loop is defined in part by notches in the lancet.