Diagnostic patch

• US 20080300508A1
• Filed: 05/30/2007
• Published: 12/04/2008
• Est. Priority Date: 05/30/2007
• Status: Abandoned Application

• Current Assignee: Alere Switzerland GmbH (Abbott Laboratories)
• Original Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories)
• Inventors: Tomer, Keren
• Application Number:
  US11/806,170
• Publication Number:
  US 20080300508A1
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• 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 5/150564 Protectors removed by pulling or pushing
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing

Abstract

The Present invention generally relates to medical diagnostics devices and more specifically to a diagnostic patch attachable to a subject'"'"'s skin for performing a rapid blood test.

A well-known format for performing assays where a sample is applied to a test strip impregnated with assay specific reagents.

Claims

1. A diagnostic device for performing a diagnostic blood test of a subject comprising a flexible patch attachable to the subject'"'"'s skin, a puncturing unit for producing a blood sample of the subject, and an at least one test element embedded in said patch in a flow communication with said blood sample.

2. The diagnostic device of claim 1 wherein the device comprises a display window through which test results can be read.

3. The diagnostic device of claim 2 wherein said test results are visibly read.

4. The diagnostic device of claim 1 wherein said patch comprises a first flexible sheet comprising an aperture located opposite the puncturing unit and a second flexible sheet overlaying said first flexible sheet and wherein said test element is sandwiched between said first and second flexible sheets in a fluid communication with said aperture.

5. The diagnostic device of claim 1 wherein the puncturing unit comprises a lancing element mounted within a flexible housing.

6. The diagnostic device of claim 1 wherein said at least one test element is a diagnostic strip adapted for a lateral flow assay of a whole blood sample.

7. The diagnostic device of claim 5 wherein said assay is an immunoassay, or an enzymatic assay, or a biochemical assay or a chemical assay.

8. The diagnostic device of claim 5 wherein said assay is a positive/negative assay.

9. The diagnostic device of claim 6 wherein said diagnostic strip is configured for detecting the presence and/or concentration of an analyte in a sample applied thereto.

10. The diagnostic strip of claim 9 wherein said analyte is a blood borne pathogen.

11. The device of claim 9 wherein said diagnostic strip is impregnated with one or more reagents disposed along the strip, said reagents are selected to provide a visible signal when said analyte is present in said sample.

12. The diagnostic device of claim 6 wherein said diagnostic strip comprises a whole blood separation zone for entrapping and retaining red blood cells.

13. The diagnostic device of claim 6 wherein said diagnostic strip comprises a sample receiving zone, a reaction zone and a detection zone.

14. The device of claim 1 further comprising a reservoir of a releasable reagent solution adapted to release the reagent solution to facilitate running the diagnostic test.

15. The device according to claim 14 wherein said reservoir of a releasable reagent solution comprises a blister made of liquid impermeable film encapsulating said reagent solution.

16. The device according to claim 15 wherein said blister is accommodated within the puncturing unit.

17. The device according to claim 15 wherein said blister is accommodated within a second puncturing unit located upstream the puncturing unit for producing the blood sample of the subject and wherein the patch comprises a channel connecting between said two puncturing units to form a flow communication between the reagent solution released from said blister and the blood sample.

18. The device of claim 1 further comprising a safety means to prevent premature activation of the puncturing unit.