Dual blade lancing test strip

• US 7,625,457 B2
• Filed: 01/03/2007
• Issued: 12/01/2009
• Est. Priority Date: 12/03/2002
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Steven N., Roe, Jeffrey N.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US11/619,439
• Publication Number:
  US 20070106178A1
• Time in Patent Office: 1,063 Days
• Field of Search: 600/573, 600/583, 600/584, 738/640.1, 606181-183, 204/403.01, 204/403.04, 204/290.11, 204/290.15, 204/403.11, 422/82.01, 156/145
• US Class Current: 156/145
• 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 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable

Abstract

An integrated lancing test strip includes a pair of blade members that each have a lancing tip that are configured to lance skin. A pair of spacer members connect the blade members together such that the blade members define an internal capillary. A test strip is positioned along the internal capillary, and the test strip is configured to test analyte levels in the bodily fluid. During use, the lancing tips form one or more incisions in the skin. The fluid from the incisions is drawn via capillary action through the internal capillary and onto the test strip.

Claims

1. A method, comprising:

providing a device with at least two spacer members that define an internal capillary for drawing body fluid, wherein a vent member spans across the at least two spacer members; and

laying a strip across the at least two spacer members and the internal capillary to define a vent slot that vents air from the internal capillary, wherein said laying the strip includes spacing the strip from the vent member to form the vent slot between the strip and the vent member.

2. The method of claim 1, wherein the strip includes a test strip that analyzes the body fluid.

3. The method of claim 1, further comprising:

creating the internal capillary by joining a first blade member and a second blade member together with the at least two spacer members.

4. The method of claim 3, further comprising:

wherein the first blade member and the second blade member each have a lancing tip; and

positioning the first blade member and the second blade member at a position where the lancing tips are angled towards one another.

5. The method of claim 4, wherein during said positioning the lancing tips are spaced apart.

6. The method of claim 2, further comprising:

sterilizing the device before said laying the strip across the at least two spacer members and the internal capillary.

7. The method of claim 2, further comprising:

wherein the internal capillary has an opening through which the body fluid is introduced; and

said laying the strip across the at least two spacer members and the internal capillary includes locating the vent slot distally away from the opening of the internal capillary to ensure the body fluid covers the test strip before reaching the vent slot.

8. The method of claim 1, wherein the vent member is a vent block that encloses one end of the internal capillary.

9. The method of claim 1, further comprising

wherein the strip includes a test strip that analyzes the body fluid;

wherein the internal capillary has an opening through which the body fluid is introduced;

wherein the opening of the internal capillary is located at an end of the device that is opposite the vent member; and

wherein said laying the strip includes positioning the test strip along the internal capillary between the vent member and the opening of the internal capillary with the vent slot located between the test strip and the vent member to ensure body fluid covers the test strip before reaching the vent slot.

10. A method, comprising:

providing a device with at least two spacer members that define an internal capillary for drawing body fluid;

laying a strip across the at least two spacer members and the internal capillary to define a vent slot that vents air from the internal capillary;

creating the internal capillary by joining a first blade member and a second blade member together with the at least two spacer members, wherein the first blade member and the second blade member each have a lancing tip;

positioning the first blade member and the second blade member at a position where the lancing tips are angled towards one another; and

wherein during said positioning the lancing tips contact one another.

11. A method, comprising:

joining a first blade member and a second blade member together to form an internal capillary;

wherein the first blade member has a first lancing tip;

wherein the second blade member has a second lancing tip;

wherein said joining includes angling the first lancing tip and the second lancing tip towards one another; and

wherein when the first lancing tip and the second lancing tip are angled towards one another with the first lancing tip is bent relative to the rest of the first blade member and the second lancing tip is bent relative to the rest of the second blade member such that the first lancing tip and the second lancing tip are in closer proximity than the rest of the first and second blade members.

12. The method of claim 11, further comprising:

creating a vent slot by laying a test strip across the internal capillary.

13. The method of claim 12, further comprising:

sterilizing the first blade member and the second blade member; and

said creating the vent slot occurs after said sterilizing.

14. The method of claim 11, wherein said joining includes adhering the first blade member to the second blade member with an adhesive bead.

15. The method of claim 11, wherein said joining includes adhering the first blade member to the second blade member with adhesive tape.

16. The method of claim 11, wherein during said joining the first and second lancing tips contact one another.

17. A method, comprising:

joining a first blade member and a second blade member together to form an internal capillary;

wherein the first blade member has a first lancing tip;

wherein the second blade member has a second lancing tip;

wherein said joining includes angling the first lancing tip and the second lancing tip towards one another;

creating a vent slot by laying a test strip across the internal capillary; and

wherein said creating the vent slot includes positioning the test strip along the internal capillary between the vent slot and the first lancing tip to ensure body fluid covers the test strip before reaching the vent slot.