Dual blade lancing test strip

• US 8,016,775 B2
• Filed: 10/19/2009
• Issued: 09/13/2011
• 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:
  US12/581,477
• Publication Number:
  US 20100042017A1
• Time in Patent Office: 694 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: 600/584
• 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 lancing device that includes at least a pair of blade members that define an internal capillary and a test strip positioned along the internal capillary, wherein the blade members each have a lancing tip, wherein the lancing tips are angled towards one another with the lancing tips being bent relative to the rest of the blade members such that the lancing tips are in closer proximity than the rest of the blade members;

lancing one or more incisions in skin with the lancing tips angled towards one another such that the lancing tips are in closer proximity than the rest of the blade members; and

drawing via capillary action between the pair blade members bodily fluid from the one or more incisions onto the test strip through the internal capillary defined by the blade members.

2. The method of claim 1, wherein said drawing the fluid includes touching a drop of the bodily fluid from the one or more incisions in the skin with the blade members.

3. The method of claim 2, wherein said lancing includes removing the blade members from the one or more incisions in the skin before said touching.

4. The method of claim 1, further comprising:

wherein the lancing tips are spaced apart before said lancing; and

supporting the lancing tips by contacting the lancing tips together as the lancing tips deflect during said lancing.

5. The method of claim 1, wherein the lancing tips contact one another before said lancing.

6. The method of claim 1, wherein the lancing tips are spaced apart from one another during said lancing.

7. The method of claim 1, wherein the lancing tips contact one another during said lancing.

8. The method of claim 1, further comprising:

venting air from the internal capillary through a vent slot located past the test strip along the internal capillary to ensure the bodily fluid covers the test strip before reaching the vent slot during said drawing.

9. The method of claim 8, wherein the vent slot is defined between the test strip and a vent block in which the test strip extends across at least two spacer members.

10. The method of claim 1, further comprising:

analyzing the bodily fluid with the test strip.

11. The method of claim 1, further comprising:

wherein said drawing the fluid includes touching a drop of the bodily fluid from the one or more incisions in the skin with the blade members;

wherein said lancing includes removing the blade members from the one or more incisions in the skin before said touching;

wherein the lancing tips are spaced apart before said lancing;

supporting the lancing tips by contacting the lancing tips together as the lancing tips deflect during said lancing;

venting air from the internal capillary through a vent slot located past the test strip along the internal capillary to ensure the body fluid covers the test strip before reaching the vent slot during said drawing;

wherein the vent slot is defined between the test strip and a vent block in which the test strip extends across at least two spacer members; and

analyzing the bodily fluid with the test strip.

12. A method, comprising:

lancing one or more incisions in tissue with a lancing device that includes a first blade member with a first lancing tip and a second blade member with a second lancing tip, wherein the first blade member and the second blade member are joined together to form an internal capillary, 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;

drawing via capillary action bodily fluid from the one or more incisions into the internal capillary defined between the first and second blade members; and

depositing the bodily fluid onto a test strip disposed along the internal capillary.

13. The method of claim 12, wherein said drawing the fluid includes touching a drop of the bodily fluid from the one or more incisions in the skin with the first and second blade members.

14. The method of claim 13, wherein said lancing includes removing the first and second tips from the one or more incisions in the skin before said touching.

15. The method of claim 12, further comprising:

wherein the first and second lancing tips are spaced apart before said lancing; and

contacting the first and second lancing tips together during said lancing.

16. The method of claim 12, further comprising:

venting air from the internal capillary through a vent slot located past the test strip along the internal capillary to ensure the bodily fluid covers the test strip before reaching the vent slot during said depositing.

17. The method of claim 12, further comprising:

analyzing the bodily fluid with the test strip.

18. The method of claim 12, further comprising:

wherein said drawing the fluid includes touching a drop of the bodily fluid from the one or more incisions in the skin with the first and second blade members;

wherein said lancing includes removing the first and second tips from the one or more incisions in the skin before said touching;

wherein the first and second lancing tips are spaced apart before said lancing;

contacting the first and second lancing tips together during said lancing;

venting air from the internal capillary through a vent slot located past the test strip along the internal capillary to ensure the bodily fluid covers the test strip before reaching the vent slot during said depositing; and

analyzing the bodily fluid with the test strip.