Automatic Biological Analyte Testing Meter with Integrated Lancing Device and Methods of Use

• US 20120083679A1
• Filed: 12/06/2011
• Published: 04/05/2012
• Est. Priority Date: 11/06/2002
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Hamerton-Kelly, Paul R., Sia, Sophia, Kennedy, Daniel F., Peterson, Matthew W., Tsang, Sammy Cheuksang, Vivolo, Joseph A., Saikley, Charles R., Lortz, W. Mark
• Granted Patent: US 9,060,727 B2
• Time in Patent Office: Days
• US Class Current: 600/365
• 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. An integrated device for sampling and testing an analyte comprising:

a housing;

a lancing device operatively coupled to said housing for sampling an analyte;

a test strip operatively coupled to said housing for substantially capturing at least a portion of the analyte; and

a display unit mounted to said housing for displaying a result corresponding to the captured portion of the analyte.

2. The device of claim 1, wherein the lancing device includes a cutting edge substantially aligned with said test strip.

3. The device of claim 1, wherein the lancing device is operatively coupled to said housing by a spring mechanism.

4. The device of claim 1, wherein the lancing device includes body having a first axis and a sharp mounted to the body, wherein the sharp has a second axis, said second axis being substantially perpendicular to said first axis.

5. The device of claim 1, wherein the lancing device includes a sharp, said sharp having a least two points, each configured for sampling the analyte.

6. The device of claim 1, wherein said lancing device is configured to draw the analyte through a test site of a patient by piercing the tissue thereof.

7. The device of claim 1, wherein said test strip is physically displaced relative to said housing to contact the analyte.

8. The device of claim 7, wherein a fill channel of said test strip is substantially aligned with the analyte.

9. The device of claim 1, wherein the result displayed on said display unit corresponds with a physiological property of the captured portion of the analyte.

10. The device of claim 9, wherein the physiological property of the captured portion of the analyte includes at least one of:

a glucose level;

a carbohydrate level;

a hemoglobin level; and

a glycated hemoglobin level.

11. The device of claim 1, further including a controller operatively coupled to said housing for controlling the operation of said lancing device.

12. The device of claim 1, further including a controller operatively coupled to said housing for controlling a movement of said test strip.

13. The device of claim 1, further including a controller operatively coupled to said housing for controlling the display on said display unit.

14. The device of claim 1, further including an input unit mounted to said housing for operating the lancing device.

15. A method for sampling and testing comprising:

placing an integrated sampling and testing device on a test site of a patient; and

performing a single operation of the device to sample an analyte from the test site, to perform analyte testing on the sample, and to display a result corresponding to the analyte testing.

16. The method of claim 15, wherein the performing a single operation includes depressing an input button.

17. The method of claim 15, wherein the analyte is sampled from the test site by displacing a test strip to contact the analyte.

18. The method of claim 15, wherein the analyte is sampled from the test site by piercing the test site with a lancing device, moving a test strip to the pierced test site to capture the analyte.

19. A method of integrating sampling and testing of an analyte comprising:

performing a single operation to sample an analyte, to capture said sampled analyte, to perform testing on said sampled analyte, and to display a result corresponding to the performed test.

20. The method of claim 19, wherein said analyte is blood.