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

• US 8,079,961 B2
• Filed: 06/23/2009
• Issued: 12/20/2011
• Est. Priority Date: 11/06/2002
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Saikley, Charles R., Hamerton-Kelly, Paul R., Sia, Sophia, Kennedy, Daniel F., Peterson, Matthew W., Lortz, W. Mark, Vivolo, Joseph A., Tsang, Sammy Cheuksang
• Primary Examiner(s): HOEKSTRA, JEFFREY GERBEN
• Application Number:
  US12/490,218
• Publication Number:
  US 20090259147A1
• Time in Patent Office: 910 Days
• Field of Search: 600/300, 600/322, 600/573, 600/576, 600/577, 600/578, 600/579, 600/580, 600/582, 600/583, 600/584, 606/167, 606/181, 606/182, 606/183
• US Class Current: 600/583
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• 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 an integrated sampling and testing device on a test site of a patient, wherein the integrated device comprises;

a housing defining at least a first aperture;

a lancing device comprising a lancet; and

a test strip;

performing a single operation of the integrated device to;

advance and withdraw the lancet through the first aperture to pierce skin of the patient to express blood at the test site without application of a vacuum to the test site through the first aperture; and

advance the test strip from a first position to a blood sample contacting position wherein the advancing of the test strip comprises moving at least a portion of a strip movement mechanism in an arcuate trajectory;

contacting the test strip to the expressed blood at the test site to receive a submicroliter sample of the blood to perform analyte testing on the blood sample; and

displaying a result corresponding to the analyte testing.

2. The method of claim 1, wherein the performing the single operation comprises depressing a button of the device.

3. The method of claim 1, wherein the submicroliter sample is of about ⅓

microliter in volume.

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

5. The method of claim 1, wherein the analyte is a ketone.

6. The method of claim 1 further comprising cocking the lancet for piercing.

7. The method of claim 6, wherein the cocking comprises pulling on a mechanism of the device.

8. The method of claim 1, wherein the test strip is moved along an axis substantially perpendicular to the test site.

9. The method of claim 1, wherein the test strip is moved along an axis substantially parallel to the lancet.

10. The method of claim 1, wherein the lancet is spring biased.

11. The method of claim 1, wherein the lancing device comprises a driving spring for driving the lancet.

12. The method of claim 11, wherein the lancing device further comprises a retracting spring for retracting the lancet.

13. The method of claim 12, wherein the driving spring and retracting spring are concentrically positioned about the lancet.

14. The method of claim 10, wherein the spring-biasing is accomplished with a torsion spring.

15. The method of claim 1, wherein the lancet and the test strip are displaced from the device in parallel axes.

16. The method of claim 1, wherein the housing further defines a second aperture, and the test strip advances to the blood sample contacting position through the second aperture.