Marker For Readings Taken From Alternative Site Tests

• US 20080119760A1
• Filed: 12/12/2005
• Published: 05/22/2008
• 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: Trzybinski, Robert, Kheiri, Mohammad A., Lok, Hoi-Wak Derek
• Granted Patent: US 8,444,575 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• 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:

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

means for distinguishing an alternative site test from a standard site test.

2. The meter of claim 1, wherein the determined analyte concentration is marked with an AST marker when the fluid sample is obtained from an alternative test site.

3. The meter of claim 1, wherein the determined analyte concentration is marked with a marker when the fluid sample is obtained from a standard test site.

4. The meter of claim 1, further comprising a button set adapted to allow a test subject to distinguish an alternative site test from a standard site test.

6. The meter of claim 1, further comprising a communications interface in communication with at least one of the electrical circuitry and the memory device, the communications interface adapted to communicate information provided by at least one of the electrical circuitry and the memory device to an external device.

10. The meter of claim 1, wherein a detection device distinguishes an alternative site test from a standard site test.

11. The meter of claim 10, further comprising at least one endcap docking station formed in the meter, the endcap docking station being adapted to seat at least one endcap for storage therein.

12. The meter of claim 11, wherein the detection device detects when an AST endcap has been removed from the at least one endcap docking station.

14. The meter of claim 11, wherein the detection device detects when a SST endcap has been removed from the at least one endcap docking station.

5. (canceled)

7-9. -9. (canceled)

13. (canceled)

15. (canceled)

16. 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 detect 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 determined analyte concentration is stored in the memory device along with a marker indicating whether the fluid sample was obtained from an alternative test site.

17. The meter of claim 16, wherein the electrical circuitry includes a read-head for optically determining the concentration of the analyte.

18. The meter of claim 16, wherein the electrical circuitry electrochemically determines the concentration of the analyte.

20. The meter of claim 16, wherein the detection device communicates to one or more of the electrical circuitry and memory device when a standard site test has been detected.

21. The meter of claim 16, wherein the meter is adapted to be used with a lancing mechanism, the detection device detecting when an AST endcap has been removably attached to the lancing mechanism.

22. The meter of claim 16, wherein the meter is adapted to be used with a lancing mechanism, the detection device detecting the distance a lance extends from the lancing mechanism to determine whether an alternative test site is being lanced.

23. The meter of claim 16, 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.

28. The meter of claim 16, 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.

29. The meter of claim 16, wherein the meter is adapted to be used with a lancing mechanism, the detection device detecting when an AST lance has been removably attached to the lancing mechanism.

30. The meter of claim 16, wherein the meter is adapted to be used with a lancing mechanism, the detection device detecting when an SST lance has been removably attached to the lancing mechanism.

31. The meter of claim 16, wherein the meter is adapted to be used with a lancing mechanism adapted to removeably attach to a lance, the lancing mechanism including an adjustment mechanism for adjusting the puncture depth of the lance, the detection device detecting when an AST puncture depth has been selected.

19. (canceled)

24-27. -27. (canceled)

32. 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 detect 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 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.

33-40. -40. (canceled)

41. 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;

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;

detecting whether an alternative test site is being lanced by the lancing mechanism;

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

marking the determined analyte concentration as being collected from the alternative test site, the marker being linked to the determined analyte concentration.

42. The method of claim 41, further comprising the act of downloading the stored, determined analyte concentration to a separate device via a communication interface provided with the meter.

43. The method of claim 41, wherein the detecting of the lancing of the alternative test site is performed by detecting whether an AST endcap has been removeably attached to the lancing mechanism.

44. The method of claim 43, wherein the detecting of the AST endcap is performed by detecting at least one electrical contact provided with the AST endcap.

45. The method of claim 43, 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.

46. The method of claim 41, wherein the detecting of the lancing of the alternative test site is performed by detecting the depth of lancing of the test subject'"'"'s skin.

47. The method of claim 41, wherein the lancing mechanism is separate from the meter.

50. The method of claim 41, wherein the determination of the analyte concentration in the applied fluid sample is performed optically.

51. The method of claim 41, wherein the determination of the analyte concentration in the applied fluid sample is performed electrochemically.

48-49. -49. (canceled)

52. (canceled)

53. 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, and

(iii) means for distinguishing an alternative site test from a standard site test;

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 an alternative test site or a standard test site.

54-60. -60. (canceled)