Diagnostic test strip having fluid transport features

• US 8,337,422 B2
• Filed: 07/14/2009
• Issued: 12/25/2012
• Est. Priority Date: 07/14/2009
• Status: Active Grant

• Current Assignee: Embecta Corporation
• Original Assignee: Becton, Dickinson & Co
• Inventors: Mondro, Jason
• Primary Examiner(s): HOEKSTRA, JEFFREY GERBEN
• Application Number:
  US12/502,585
• Publication Number:
  US 20110015545A1
• Time in Patent Office: 1,260 Days
• Field of Search: 600/583, 600/584
• US Class Current: 600/583
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0672 Integrated piercing tool
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• CPC Class Codes: G01N 33/559 through a gel, e.g. Ouchterlony technique
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose

Abstract

A test strip for testing a blood sample is provided with a fluid transport feature to facilitate transport of a blood sample obtained from a lancing operation through a capillary channel to a measurement site. A fluid transport path is defined on the major face of the strip terminating at the mouth of the capillary channel. The fluid transport path includes a depending portion at one end opposite the mouth of the channel. The depending portion extends away from the strip on the side facing the fluid sample, such that a droplet of fluid sample contacting the depending portion is directed toward the mouth of the capillary channel. Thereafter the sample moves by capillary action to the measurement site.

Claims

1. A test strip for testing a fluid sample, comprising:

a strip with a first major side for positioning facing a the fluid sample;

a capillary channel having a mouth and having a measurement site;

a raised fluid transport path on the strip terminating at the mouth of the capillary channel;

a raised depending portion that is integral to the raised fluid transport path and positioned at an end of the raised fluid transport path opposite the mouth of the capillary channel, whereby a droplet of the fluid sample contacting the raised depending portion is directed to the raised fluid transport path; and

a lancet hole through the strip that is positioned laterally adjacent to the raised depending portion.

2. The test strip according to claim 1, wherein the raised depending portion is formed by two slits in the strip extending from the lancet hole in a direction toward the capillary channel.

3. The test strip according to claim 1, wherein the strip is bent, causing the raised depending portion to extend away from the first major side of the test strip by at least about 100 μ

m.

4. The test strip according to claim 1, wherein the lancet hole has a widest dimension of about 1 mm to about 2 mm.

5. The test strip according to claim 2, wherein the two slits have an approximately equal length of greater than about 1 mm forming the raised depending portion at the side of the lancet hole.

6. The test strip according to claim 1, wherein a portion of the strip is in a bent state, and moves along the strip during use in a direction opposite to the direction of fluid sample on the strip.

7. The test strip according to claim 1, wherein the measurement site comprises wells containing reagent for an electrochemical detection of glucose in a blood sample.

8. The test strip according to claim 1, wherein a surface of the capillary channel is hydrophilic.

9. The test strip according to claim 1, wherein a surface of the raised fluid transport path is hydrophobic.

10. The test strip according to claim 8, wherein the surface of the capillary channel has sufficient hydrophilicity so that a droplet of blood thereon forms a contact angle of less than about 50 degrees.

11. The test strip according to claim 9, wherein the surface of the raised fluid transport path has sufficient hydrophobicity so that a droplet of blood thereon forms a contact angle of greater than about 50 degrees.

12. The test strip according to claim 1, comprising a plurality of patterned polymeric structural layers that are configured to form when successively stacked the strip, the raised fluid transport path and integral raised depending portion, and the capillary channel.

13. The test strip according to claim 1, wherein the volume of the capillary channel is less than about 1.0 μ

L.

14. The test strip according to claim 1, further comprising two recesses respectively adjacent to each lateral side of the raised fluid transport path, each recess extending substantially the entire length of the raised fluid transport path, from near the raised depending portion to near the mouth of the capillary channel.

15. A test strip for testing a fluid sample, comprising:

a strip with a first major side for positioning the fluid sample;

a capillary channel having a mouth and having a measurement site;

a raised fluid transport path on the strip having sides and an end at the mouth of the capillary channel;

at least one recess adjacent a side of the raised fluid transport path, whereby the fluid sample contacting the raised fluid transport path is preferentially directed to the mouth of the capillary channel; and

a lancet hole through the strip that is positioned adjacent to a raised depending portion, the raised depending portion being integral to the raised fluid transport path and positioned at an end of the raised fluid transport path opposite the mouth of the capillary channel.

16. The test strip according to claim 15, wherein the at least one recess comprises two recesses respectively positioned on opposite sides of the raised fluid transport path, such that the raised fluid transport path has a width narrower than the lancet hole at its widest point.