Marker for readings taken from alternative site tests

• US 8,444,575 B2
• Filed: 12/12/2005
• Issued: 05/21/2013
• Est. Priority Date: 12/13/2004
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Lok, Hoi-Wak Derek, Trzybinski, Robert, Kheiri, Mohammad A.
• Primary Examiner(s): Szmal, Brian
• Assistant Examiner(s): LLOYD, EMILY M
• Application Number:
  US11/792,322
• Publication Number:
  US 20080119760A1
• Time in Patent Office: 2,717 Days
• Field of Search: 600/573, 600/574, 600/583, 600/584, 606/181
• US Class Current: 600/584
• 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 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• 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 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• 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 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 27/26 by investigating electrochemical variables; by using electrolysis or electrophoresis
• CPC Class Codes: G01N 33/48792 Data management, e.g. communication with processing unit for in vivo diagnostics A61B5/0002; transmission systems for measured values G08C

Abstract

A meter for determining the concentration of an analyte in a fluid sample comprises a memory device, electrical circuitry and a detection device for distinguishing between an alternative site test and a standard site test. The memory device is adapted to store information. The electrical circuitry is adapted to determine the analyte concentration of the fluid sample located on a test sensor. The electrical circuitry is in electronic communication with the memory device. The electrical circuitry communicates the determined analyte concentration to the memory device for storage.

Claims

1. A meter for determining the concentration of an analyte in a fluid sample, the meter comprising:

a memory device adapted to store information;

an electrical circuitry adapted to determine the analyte concentration of the fluid sample located on a test sensor, the electrical circuitry being in electronic communication with the memory device, the electrical circuitry communicating the determined analyte concentration to the memory device for storage; and

a detection device adapted to determine when the meter is being used for an alternative site test, the detection device being in electronic communication with the memory device and electrical circuitry, wherein the meter is adapted to be used with a lancing mechanism, and the detection device detects a distance that a lance extends from a portion of the lancing mechanism and determines whether the detected distance exceeds a threshold to determine whether an alternative test site is being lanced, the detection device distinguishing the alternative test site from a standard test site according to whether the distance exceeds the threshold,

wherein, in response to the detection device determining that the alternative test site is being lanced, the determined analyte concentration is stored in the memory device along with a marker indicating whether the fluid sample was obtained from the alternative test site.

2. The meter of claim 1, wherein the electrical circuitry includes a read-head for optically determining the concentration of the analyte.

3. The meter of claim 1, wherein the electrical circuitry electrochemically determines the concentration of the analyte.

4. The meter of claim 1, wherein the detection device communicates to one or more of the electrical circuitry and memory device when a standard site test has been detected.

5. The meter of claim 1, wherein the lancing mechanism includes a removably attachable AST (alternative site test) endcap, the AST endcap configuring the lancing mechanism to collect the fluid sample from the alternative test site, the detection device detecting a distance the lance extends from the end cap to determine whether an alternative test site is being lanced.

6. The meter of claim 5, wherein the detection device further detects when the AST endcap has been removably attached to the lancing mechanism.

7. The meter of claim 6, wherein the detection device detects the AST endcap by detecting at least one electrical contact provided with the AST endcap.

8. The meter of claim 6, wherein the detection device detects the AST endcap by detecting when the AST endcap is applied to an alternative-site seat on the lancing mechanism.

9. The meter of claim 5, wherein the AST endcap is formed from an optically clear material.

10. The meter of claim 1, wherein the detection device of the meter is in communication with an external detection device, the external detection device being located in a lancing mechanism, the external detection device being adapted to communicate to the detection device of the meter when the lancing mechanism is being used to obtain a fluid sample from an alternative test site.

11. The meter of claim 1, wherein the electrical circuitry includes a communication interface adapted to communicate information provided by one or more of the electrical circuitry and memory device to an external device.

12. The meter of claim 1, wherein the detection device further detects when an AST (alternative site test) lance has been removably attached to the lancing mechanism, the AST lance configuring the lancing mechanism to collect the fluid sample from the alternative test site.

13. The meter of claim 1, wherein the detection device further detects when an SST (standard site test) lance has been removably attached to the lancing mechanism, the SST lance configuring the lancing mechanism to collect the fluid sample from a standard test site, the standard test site being different from the alternative test site.

14. The meter of claim 1, wherein the lancing mechanism includes an adjustment mechanism for adjusting the distance the lance extends from the lancing mechanism.

15. An integrated meter for determining the concentration of an analyte in a fluid sample, the integrated meter comprising:

a lancing mechanism adapted to assist in the collection of the fluid sample, the lancing mechanism including an endcap and a removably attachable lance disposed at least partially therein;

a memory device adapted to store information;

an electrical circuitry adapted to determine the analyte concentration of the fluid sample located on a test sensor, the electrical circuitry being in electronic communication with the memory device, the electrical circuitry communicating the determined analyte concentration to the memory device for storage; and

a detection device adapted to determine when the lancing device is being used to assist in the collection of the fluid sample from an alternative test site, the detection device being in electronic communication with the memory device and electrical circuitry, wherein the detection device detects a distance that the lance extends from a portion of the lancing mechanism and determines whether the detected distance exceeds a threshold to determine whether an alternative test site is being lanced, the detection device distinguishing the alternative test site from a standard test site according to whether the distance exceeds the threshold,

wherein, in response to the detection device determining that the alternative test site is being lanced, the determined analyte concentration is stored in the memory device along with a marker indicating that the fluid sample was obtained from the alternative test site.

16. A method for determining an analyte concentration in a fluid sample, the method comprising the acts of:

providing a meter adapted to determine the analyte concentration in the fluid sample after the fluid sample has been applied to a test sensor, the meter having a memory device adapted to store information and a display adapted to display information to a user;

providing a lancing mechanism including at least one removeably attachable endcap;

attaching the at least one endcap to the lancing mechanism;

collecting the fluid sample by lancing the skin of a test subject with a lance removably attached to the lancing mechanism;

determining whether an alternative test site is being lanced by the lancing mechanism by detecting a distance the lance extends from a portion of the lancing mechanism and determining whether the detected distance exceeds a threshold, the alternative test site being distinguishable from a standard test site according to whether the distance exceeds the threshold;

applying the collected fluid sample to the test sensor;

determining the analyte concentration in the applied fluid sample;

storing the determined analyte concentration in the memory device; and

in response to determining that the alternative test site is being lanced, marking the determined analyte concentration as being collected from the alternative test site, the marker being linked to the determined analyte concentration, and displaying, on the display of the meter, an indication that the determined analyte concentration is collected from the alternative test site.

17. The method of claim 16, further comprising the act of downloading the stored determined analyte concentration to a separate device via a communication interface provided with the meter.

18. The method of claim 16, wherein the determining of the lancing of the alternative test site further includes detecting whether an AST (alternative site test) endcap has been removably attached to the lancing mechanism, the AST endcap configuring the lancing mechanism to collect the fluid sample from the alternative test site.

19. The method of claim 18, wherein the detecting of the AST endcap is performed by detecting at least one electrical contact provided with the AST endcap.

20. The method of claim 18, wherein the detecting of the AST endcap is performed by detecting when the AST endcap is applied to an alternative-site seat on the lancing mechanism.

21. The method of claim 16, wherein the lancing mechanism is separate from the meter.

22. The method of claim 16, wherein the determination of the analyte concentration in the applied fluid sample is performed optically.

23. The method of claim 16, wherein the determination of the analyte concentration in the applied fluid sample is performed electrochemically.

24. The method of claim 16, wherein the lancing mechanism includes a removably attachable AST (alternative site test) endcap, the AST endcap configuring the lancing mechanism to collect the fluid sample from the alternative test site, and the detecting of the distance includes detecting a distance that the lance extends from the endcap.

25. The method of claim 24, wherein the AST endcap is formed from an optically clear material.

26. The method of claim 16, wherein the determining of the lancing of the alternative test site further includes detecting when an AST (alternative site test) lance has been removably attached to the lancing mechanism, the AST lance configuring the lancing mechanism to collect the fluid sample from the alternative test site.

27. The method of claim 16, wherein the determining of the lancing of the alternative test site further includes detecting when an SST (standard site test) lance has been removably attached to the lancing mechanism, the SST lance configuring the lancing mechanism to collect the fluid sample from a standard test site, the standard test site being different from the alternative test site.

28. The method of claim 16, further comprising adjusting the distance that the lance extends from the lancing mechanism.

29. A method for determining an analyte concentration in a fluid sample, the method comprising the acts of:

providing a meter having

(i) a memory device adapted to store information,

(ii) an electrical circuitry adapted to determine the analyte concentration of the fluid sample located on a test sensor, the electrical circuitry being in electronic communication with the memory device, the electrical circuitry communicating the determined analyte concentration to the memory device for storage,

(iii) a display adapted to display information to a user, and

(iv) a detection device adapted to determine when the meter is being used for an alternative site test, the detection device being in electronic communication with the memory device and electrical circuitry, wherein the meter is adapted to be used with a lancing mechanism, and the detection device detects a distance that a lance extends from a portion of the lancing mechanism and determines whether the detected distance exceeds a threshold to determine whether an alternative test site is being lanced, the detection device distinguishing the alternative test site from a standard test site according to whether the distance exceeds the threshold;

marking the determined analyte concentration with a marker, the marker being linked to the determined analyte concentration, the marker distinguishing the determined analyte concentration as being from the fluid sample collected from either the alternative test site or the standard test site; and

displaying, on the display of the meter, an indication that the determined analyte concentration is collected from the alternative test site.