Self-contained hand-held test device for single-use

• US 9,211,087 B2
• Filed: 10/18/2012
• Issued: 12/15/2015
• Est. Priority Date: 10/18/2012
• Status: Active Grant

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Animas Corporation (Johnson & Johnson)
• Inventors: Hutchinson, Michael
• Primary Examiner(s): Ball, J. Christopher
• Application Number:
  US13/654,428
• Publication Number:
  US 20140114155A1
• Time in Patent Office: 1,153 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1477 non-invasive
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• 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 5/150549 Protectors removed by rotational movement, e.g. torsion or screwing
• CPC Class Codes: A61B 5/150717 manually removed
• 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 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A self-contained hand-held test device for the single-use determination of an analyte (such as glucose) in a bodily fluid sample (for example, a whole blood sample) includes a housing with proximal and distal ends, a housing cap configured for removable attachment to the distal end of the housing, a single analytical test strip (e.g., a single electrochemical-based analytical test strip) disposed partially in the housing and extending from the distal end thereof, a meter module disposed in the housing, and a lancing module attached to the proximal end of the housing. The lancing module is configured to lance a user'"'"'s target site (such as a fingertip or other suitable site) for the expression of a bodily fluid sample. In addition, the single analytical test strip has a bodily fluid sample application portion and a meter module contact portion and is operably connected to the meter module in user irreplaceable manner.

Claims

1. A self-contained hand-held test device for the single-use determination of an analyte in a bodily fluid sample, the self-contained test device comprising:

a housing with;

a proximal end;

a distal end; and

a housing cap configured for removable attachment to the distal end of the housing;

a single analytical test strip disposed partially in the housing and extending from the distal end thereof, the single analytical test strip having;

a bodily fluid sample application portion; and

a meter module contact portion;

a meter module disposed in the housing; and

a lancing module attached to the proximal end of the housing and configured to lance a user'"'"'s target site for the expression of a bodily fluid sample, and

wherein the single analytical test strip is operably connected to the meter module in a user irreplaceable manner.

2. The self-contained hand-held test device of claim 1 wherein from the housing, housing cap and meter module are configured such that removal of the housing cap from the housing results in automatic activation of the self-contained hand-held test device and exposes the bodily fluid sample application portion of the single analytical test strip.

3. The self-contained hand-held test device of claim 1 further comprising an outer package enclosing the housing, housing cap, single analytical test strip, meter module, and lancing module.

4. The self-contained hand-held test device of claim 1 wherein the lancing module includes:

a lancet;

a lancet retainer;

a lancet spring;

a height adjustment cap; and

a lancet guard,

and wherein the lancet is user moveable, against a force generated by the lancet spring, between a staged position within the lancet guard and a lancing position extending from the lancet guard, and

wherein the lancet guard is configured for placement against a target site.

5. The self-contained hand-held test device of claim 4 wherein the lancing module further includes a lancet protective disk, and

wherein the lancet spring is configured to position the lancet guard, upon removal of the lancet protective disk, such that the lancet guard shields the lancet.

6. The self-contained hand-held test device of claim 1 wherein the housing further includes an ambient light opening and the meter module further includes an ambient light sensor, and

wherein the ambient light opening and the ambient light sensor are configured to activate the self-contained hand-held test meter when the housing cap is removed and ambient light enter the housing through the ambient light opening.

7. The self-contained hand-held test device of claim 1 wherein the meter module includes a non-rechargeable battery permanently sealed within the housing.

8. The self-contained hand-held device of claim 6 wherein the non-rechargeable battery stores an electrical charge sufficient to power the self-contained hand-held device following activation for less than 24 hours.

9. The self-contained test hand-held device of claim 1 wherein the meter module is configured for the determination of glucose in a whole blood sample.

10. The self-contained hand-held test device of claim 1 wherein the distal end of the housing is configured to prevent removal and replacement of the single analytical test strip by a user.

11. The self-contained hand-held test device of claim 1 further including a Universal Serial Bus (USB) interface.

12. The self-contained hand-held test device of claim 1 further including a Radio Frequency (RF) communication module.

13. A method for the determination of an analyte in a bodily fluid sample, the method comprising:

removing a housing cap of a self-contained hand-held test device from a distal end of the self-contained hand-held test device, thus exposing a bodily fluid sample application portion of a single analytical test strip of the self-contained hand-held test device;

enabling a lancet module of the self-contained hand-held test device;

lancing a target site to express a bodily fluid sample therefrom using a lancet of the lancing module;

applying the expressed bodily fluid sample to the bodily fluid sample application portion of the single analytical test strip;

measuring an electrochemical response of the single analytical test strip using a meter module of the self-contained hand-held test device;

determining, using the meter module, the analyte based on the measured electrochemical response; and

discarding the hand-held self-contained test device after a single determining step,

wherein the single analytical test strip is operably connected to the meter module in a user irreplaceable manner.

14. The method of claim 13 wherein the removing step also activates the meter module of the self-contained hand-held test device.

15. The method of claim 14 wherein the activating of the meter module occurs due to ambient light striking a light sensor of the meter module upon removal of the housing cap.

16. The method of claim 13 wherein the bodily fluid sample is a whole blood sample.

17. The method of claim 16 wherein the analyte is glucose.

18. The method of claim 13 wherein the single analytical test strip is an electrochemical-based analytical test strip.

19. The method of claim 13 wherein the enabling step involves removing a lancet protective disk from the lancet module.

20. The method of claim 13 further including adjusting a lancing depth by rotating a height adjustment cap of the lancing module prior to lancing the target site.

21. The method of claim 13 wherein the lancing of the target site occurs against a force generated by a lancet spring of the lancing module.

22. The method of claim 13 further including removing an outer package of the self-contained hand-held test device prior to the removing of the housing cap.