INTEGRATED DISPOSABLE FOR AUTOMATIC OR MANUAL BLOOD DOSING

• US 20100113977A1
• Filed: 01/13/2010
• Published: 05/06/2010
• 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 8,636,674 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. 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.

2. The method of claim 1, further comprising:

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

3. The method of claim 1, further comprising:

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

4. The method of claim 1, in which said securing the at least two spacers includes fixing the at least two spacers to the lancet with adhesive.

5. 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;

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

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.

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

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

8. The method of claim 6, wherein said forming the second opening in the lancet includes photo-etching the second opening in the lancet.

9. The method of claim 6, wherein said forming the second opening in the lancet includes locating the second opening directly over the test media.

10. The method of claim 5, further comprising:

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

wherein said forming the second opening includes forming the second opening in at least one of the at least two spacers.

11. The method of claim 10, further comprising:

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

12. The method of claim 10, wherein said forming the second opening includes tapering the second opening to reduce dose hesitation.

13. The method of claim 5, wherein said creating the capillary channel includes covering the capillary channel with a hydrophilic fluid collection sheet that extends from the first opening.

14. The method of claim 5, further comprising

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

wherein said forming the second opening in the lancet includes locating the second opening directly over the test media; and

wherein said creating the capillary channel includes covering the capillary channel with a hydrophilic fluid collection sheet that extends from the first opening.

15. The method of claim 5, further comprising:

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

wherein said forming the second opening includes forming the second opening in at least one of the at least two spacers;

securing a hydrophilic fluid collection sheet to the at least two spacers; and

wherein said forming the second opening includes tapering the second opening to reduce dose hesitation.