Diagnostic thimble

• US 7,591,791 B2
• Filed: 06/21/2007
• Issued: 09/22/2009
• Est. Priority Date: 06/21/2007
• Status: Active Grant

• Current Assignee: Alere Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories Incorporated)
• Inventors: Keren, Tomer
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US11/766,203
• Publication Number:
  US 20080319347A1
• Time in Patent Office: 824 Days
• Field of Search: 600/300, 600/301, 600/309, 600/500, 600/509, 600/583, 600/584, 128/920, 422/100, 422/101, 422 55- 58, 422/61, 422/68.1, 435/7.1, 435/286.4, 435/287.1, 435/287.2, 435/287.9, 606181-183
• US Class Current: 600/584
• 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 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• 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
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/6838 Clamps or clips

Abstract

A diagnostic device for performing a diagnostic blood test of a subject comprising a thimble-like element adapted to be engaged with the subject'"'"'s finger, a puncturing unit for producing a blood sample from the subject'"'"'s finger, and an at least one test element in flow communication with said blood sample.

Claims

1. A diagnostic device for performing a diagnostic blood test of a subject, the device comprising a tubular body mountable on the subject'"'"'s fingertip, wherein said tubular body comprises:

an open end adapted to receive the subject'"'"'s fingertip;

a transparent window in said tubular body;

a puncturing unit attached to said tubular body, the puncturing unit comprising a retractable lancing element for producing a blood sample from the subject'"'"'s fingertip; and

at least one diagnostic strip impregnated with assay specific reagents positioned inside said tubular body, the diagnostic strip comprising a sample receiving zone and a detection zone where a visible signal indicative of test results is formed, the diagnostic strip is positioned inside said tubular body such that said sample receiving zone is in fluid communication with the blood sample produced by said puncturing unit and said detection zone is visible through said transparent window.

2. The diagnostic device of claim 1 wherein said diagnostic strip is adapted for a lateral flow assay of a whole blood sample.

3. The diagnostic device of claim 2 wherein said assay is an immunoassay, an enzymatic assay, a biochemical assay or a chemical assay.

4. The diagnostic device of claim 2 wherein said assay is a positive/negative assay.

5. The diagnostic device of claim 1 wherein said diagnostic strip is configured for detecting the presence and/or concentration of an analyte in said blood sample.

6. The diagnostic device of claim 5 wherein the assay specific reagents include one or more reagents disposed along the diagnostic strip, said reagents are selected to provide a visible signal when said analyte is present in said sample.

7. The diagnostic device of claim 6 wherein said analyte is a blood borne pathogen.

8. The diagnostic device of claim 1 wherein said diagnostic strip comprises a whole blood separation zone for entrapping and retaining red blood cells.

9. The diagnostic device of claim 1 wherein said diagnostic strip comprises a reaction zone interposed between said sample receiving zone and said detection zone.

10. The diagnostic 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.

11. The diagnostic device according to claim 10 wherein said reservoir of the releasable reagent solution comprises a blister made of liquid impermeable film encapsulating said reagent solution.

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

13. The diagnostic device of claim 1 wherein the retractable lancing element is a solid pointed element and wherein the blood sample is drawn away from the retractable lancing element into the diagnostic strip.

14. The diagnostic device of claim 1 wherein the retractable lancing element is configured to penetrate through said tubular body.

15. The diagnostic device of claim 1 wherein the retractable lancing element is configured to penetrate through a blood sample absorbent member in fluid communication with the detection zone of said diagnostic strip.

16. The diagnostic device of claim 1 wherein the tubular body is made of a plastic material.

17. The diagnostic device of claim 1 wherein the tubular body comprises means to limit the extent of penetration of the finger into said tubular body such that in use the subject'"'"'s fingertip is positioned over a sample absorbent member in fluidic connection with the detection zone of the diagnostic strip.

18. A method for conducting a diagnostic blood test of a subject comprising:

providing the diagnostic device of claim 1;

mounting said diagnostic device on a fingertip of said subject;

activating the puncturing unit to puncture said subject'"'"'s fingertip to produce a blood sample;

allowing the blood sample to be drawn from the subject'"'"'s fingertip into the diagnostic strip; and

detecting appearance of a signal in the detection zone of said diagnostic strip through the transparent window.

19. The method of claim 18, further comprising a step of puncturing a reservoir of a releasable reagent solution to be drawn into said diagnostic strip.