Automatic biological analyte testing meter with integrated lancing device and methods of use

• US 9,060,727 B2
• Filed: 12/06/2011
• Issued: 06/23/2015
• Est. Priority Date: 11/06/2002
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Saikley, Charles R., Hamerton-Kelly, Paul R., Sia, Sophia, Kennedy, Daniel F., Peterson, Matthew W., Tsang, Sammy Cheuksang, Lortz, W. Mark, Vivolo, Joseph A.
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US13/312,275
• Publication Number:
  US 20120083679A1
• Time in Patent Office: 1,295 Days
• Field of Search: 600/583, 600/584, 600/585, 600/587, 600/573
• 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 5/150022 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 5/150114 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/15019 Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism mechanisms using distal end caps A61B5/150183, mechanisms at the piercing element carrier proximal end A61B5/150198
• 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 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150549 Protectors removed by rotational movement, e.g. torsion or screwing
• CPC Class Codes: A61B 5/150618 Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/150732 Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube,
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 2205/0266 : Shape memory materials

Abstract

The invention is directed to an integrated device for sampling and testing an analyte. The device generally comprises a housing, a lancing device for sampling an analyte, a test strip for substantially capturing at least a portion of the analyte, and a display unit for displaying a result corresponding to the captured portion of the analyte. The invention is further directed to methods for sampling and testing. For example, one method comprises performing a single operation to sample an analyte, to capture the sampled analyte, to perform testing on the sampled analyte, and to display a result corresponding to the performed test. A method such as this can be carried out using an integrated sampling and testing device of the invention, for example, by placing the device the device on a test site of a subject, such as a patient, and performing the single operation to obtain a test result. The invention has particular application in the sampling and testing of analytes in blood, such as the blood of a diabetic patient.

Claims

1. A method for sampling and testing an analyte comprising:

placing a testing device on a test site of a patient; and

performing analyte testing on a sample by performing a single operation comprising depressing a button of the testing device to thereby pierce the skin of a patient to express blood therefrom, contact the expressed blood with a test strip by advancing the test strip in an arcuate trajectory within the testing device, and display a result corresponding to the analyte testing.

2. The method of claim 1, wherein performing analyte testing comprises holding the testing device at the test site while the expressed blood is contacted with the test strip.

3. The method of claim 1, wherein the testing device comprises a housing and a lancet and the analyte is sampled from a test site by piercing the test site with the lancet and moving the test strip within the housing to the pierced test site to capture the analyte.

4. The method of claim 1, wherein said analyte is contained in blood.

5. The method of claim 1, further comprising displaying on a display of the testing device instructions guiding a subject through a method of testing of analyte concentration using the device.

6. The method of claim 1, wherein performing analyte testing comprises determining one or more characteristics of an analyte in the sample.

7. The method of claim 6, wherein the one or more characteristics of an analyte comprises a glucose level;

a carbohydrate level;

a hemoglobin level;

or a glycated hemoglobin level.

8. The method of claim 1, wherein depressing the button of the testing device expresses blood at the test site without application of a vacuum to the test site.

9. The method of claim 1, wherein the testing device comprises a strip movement mechanism and advancing the test strip comprises moving at least a portion of a strip movement mechanism in an arcuate trajectory.

10. The method of claim 1, wherein the sample is a submicroliter sample of blood.

11. The method of claim 1, wherein the testing device comprises a lancet, a housing, and a cap removably attached to the housing, wherein the cap comprises an aperture configured to receive at least a sharp portion of the lancet therethrough.

12. The method of claim 11, wherein performing analyte testing by depressing a button of the testing device comprises advancing the test strip to a blood sample contacting position on the skin of the patient through the aperture.

13. The method of claim 11, wherein the cap comprises an arcuate cap guide channel and advancing the test strip in an arcuate trajectory within the testing device comprises moving the test strip along the cap guide channel in a radius arc.

14. The method of claim 11, wherein the housing comprises a slot comprising a mating connector and the method further comprises inserting the test strip into the slot before performing analyte testing and ejecting the test strip from the slot after performing analyte testing.

15. The method of claim 11, wherein the lancet is spring biased.

16. The method of claim 15, wherein the lancet comprises a driving spring for driving the lancet.

17. The method of claim 15, wherein the lancet further comprises a retracting spring for retracting the lancet.

18. The method of claim 1, wherein performing analyte testing by depressing a button of the testing device comprises squeegeeing the test strip along the skin of the patient at a blood sample contacting position.

19. The method of claim 1, wherein the analyte is glucose.

20. The method of claim 1, further comprising cocking the lancet for piercing by pulling on a mechanism of the testing device.