Test strip with a shaped tip for skin straightening

• US 9,475,044 B2
• Filed: 10/14/2011
• Issued: 10/25/2016
• Est. Priority Date: 08/20/2009
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Keil, Michael
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): FISHER, BRITTANY I
• Application Number:
  US13/273,409
• Publication Number:
  US 20120035506A1
• Time in Patent Office: 1,838 Days
• Field of Search: 422/404
• US Class Current: 1/1
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• 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 5/150435 Specific design of proximal end
• 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 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: Y10T 156/1052 with cutting, punching, tearing or severing
• CPC Class Codes: Y10T 29/49789 Obtaining plural product pieces from unitary workpiece
• CPC Class Codes: Y10T 29/49798 Dividing sequentially from leading end, e.g., by cutting or breaking
• CPC Class Codes: Y10T 29/49885 with coating before or during assembling

Abstract

The test strip stabilizes skin prior to incision by a lancet tip. The innovative test strip includes a pair of skin contacting tabs that apply pressure linearly to the skin to stretch the skin taut. Beneficially an incision by a lancet tip to an accurate depth can be formed on the taut skin. Moreover, pressure from the tabs is applied linearly to the skin which results in a higher ratio of pressure to surface that can be reached as compared to applying pressure laminarily to skin. Some manufacturing techniques of the skin contacting tabs include cutting or stamping through all of the layers and test area of the test strip to form these tabs. These techniques increase the manufacturing efficiency and cost savings associated with test strips and integrated lancet testing devices. Contamination from other sampling events is eliminated since the test strips are disposed of after each use.

Claims

1. A test strip, comprising:

a body including a front edge, said body defining a passageway open at the front edge and extending from the front edge in a first, inward direction to a test area;

a reagent located in the test area;

a first skin contacting tab configured to contact skin near an incision site, said first skin contacting tab being substantially flat and extending from the front edge in a second, outward direction opposite to the inward direction; and

a second skin contacting tab configured to contact skin near an incision site, said second skin contacting tab being substantially flat and extending from the front edge in the second, outward direction opposite to the inward direction, the front edge extending between the first and second skin contacting tabs, said second skin contacting tab being coplanar with said first skin contacting tab, wherein said first skin contacting tab and said second skin contacting tab are spaced from each other a distance sufficient to stretch the skin between said first skin contacting tab and said second skin contacting tab when the test strip is pressed against the skin,

said body comprising a first panel overlying a second panel, the passageway extending between the first and second panels in the first direction from the front edge to the test area, each of the first and second panels including substantially flat, first and second skin contacting tabs extending from the front edge in the second, outward direction.

2. The test strip of claim 1, wherein:

said first skin contacting tab includes a first skin contacting portion connected to a first leg portion,

said second skin contacting tab includes a second skin contacting portion connected to a second leg portion,

said first skin contacting portion and said second skin contacting portion are configured to stretch the skin positioned between said first skin contacting tab and said second skin contacting tab.

3. The test strip of claim 2, wherein said first skin contacting portion and said second skin contacting portion have mutually-facing rounded shapes positioned away from said body.

4. The test strip of claim 3, wherein the mutually-facing rounded shapes of said first and second skin contacting portions have an approximate radius of 1.6 millimeters.

5. The test strip of claim 4, wherein said test area and the front edge each have a width of approximately 2.5 millimeters.

6. The test strip of claim 2, wherein said first skin contacting portion and said second skin contacting portion have mutually-facing portions positioned away from said body and angled inwardly in the direction of the body.

7. The test strip of claim 1, further comprising:

a lancet coupled to said test strip to form an integrated lancet test strip, the lancet having a first position extending outwardly in the second direction from the front edge of said body between said first and second skin contacting tabs a distance sufficient to lance skin pressed against and stretched by said skin contacting tabs, and a second position withdrawn into said body.

8. The test strip of claim 7 further comprising a housing coupled to said test strip.

9. A method of using the test strip of claim 1, comprising:

positioning the first skin contacting tab and the second skin contacting tab of said test strip over an incision site on skin;

pressing said first skin contacting tab and said second skin contacting tab of said test strip against the skin to cause the skin to bulge towards the test area on said test strip; and

stretching the skin between said first skin contacting tab and said second skin contacting tab of said test strip.

10. The method of claim 9, further comprising forming an incision in skin with a lancet.

11. The test strip of claim 1 in which said body and said first and second skin contacting tabs comprise a single, integral layer.

12. The test strip of claim 7 in which said body and said first and second skin contacting tabs comprise a single, integral layer.