Method of manufacturing a test strip

• US 8,061,004 B2
• Filed: 08/20/2009
• Issued: 11/22/2011
• 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): COZART, JERMIE E
• Application Number:
  US12/544,296
• Publication Number:
  US 20110046453A1
• Time in Patent Office: 824 Days
• Field of Search: 294/12, 294/17, 294/58, 295/57, 600/583
• US Class Current: 29/412
• 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 method of manufacturing a test strip, comprising:

assembling said test strip having a test area including a test chemistry, said test area configured to collect a body fluid sample via capillary action and analyze said body fluid sample, and

cutting through said test strip to form a first skin contacting tab and a second skin contacting tab after said assembling.

2. The method of claim 1, wherein said assembling includes:

disposing said test area onto either a first panel or a second panel; and

laminating said first panel to said second panel.

3. The method of claim 1, wherein said cutting includes stamping the test strip.

4. The method of claim 1, wherein said cutting includes cutting through said test area.

5. The method of claim 1, further comprising:

attaching a lancet to said test strip to form an integrated lancet test strip.

6. A method of manufacturing a plurality of test strips, comprising:

providing a first panel and a second panel wherein each of said first panel and said second panel includes a continuous sheet of material;

disposing a test area having a reagent onto either said first panel or said second panel;

assembling said first panel with said second panel;

cutting through said first panel and said second panel to form a plurality of test strips after said assembling; and

cutting through said plurality of test strips to form a first skin contacting tab and a second skin contacting tab for each of said plurality of test strips.

7. The method of claim 6, wherein said cutting includes cutting through said test area.