Marker for readings taken from alternative site tests

• US 9,448,197 B2
• Filed: 03/14/2013
• Issued: 09/20/2016
• Est. Priority Date: 12/13/2004
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Inventors: Lok, Hoi-Wah Derek, Trzybinski, Robert, Kheiri, Mohammad A.
• Primary Examiner(s): Dvorak, Linda
• Assistant Examiner(s): LLOYD, EMILY M
• Application Number:
  US13/826,105
• Publication Number:
  US 20130196421A1
• Time in Patent Office: 1,286 Days
• Field of Search: 600/573, 600/583, 600/584, 606/181
• US Class Current: 1/1
• 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. An integrated meter for determining a concentration of an analyte in a fluid sample located on a test sensor, the meter comprising:

a housing;

a memory device coupled to the housing and adapted to store information;

a sample collection system coupled to the housing and including a sample collection mechanism and a detection device, the sample collection mechanism being configured to obtain the fluid sample, and the detection device including a sensor connected to the sample collection mechanism and adapted to detect a characteristic of the sample collection mechanism; and

an electrical circuitry coupled to the housing and adapted to operatively connect to the test sensor and determine the analyte concentration of the fluid sample located on the test sensor, the electrical circuitry being in electronic communication with the memory device, the electrical circuitry being further adapted to communicate the determined analyte concentration to the memory device for storage, the electrical circuitry including a first communication interface adapted to communicate with the sample collection system,

wherein the sample collection mechanism is adapted to obtain the fluid sample from a first test site or a second test site on a test subject, the sample collection system including a second communication interface, the detection device being adapted to determine, from the characteristic of the sample collection mechanism detected by the sensor, whether the sample collection system is being used to obtain the fluid sample from the first test site or the second test site, the second communication interface being adapted to communicate the determined test site to the first communication interface,

wherein the memory device is configured to store, in association with the analyte concentration, a marker indicating whether the fluid sample was obtained from the first test site or the second test site.

2. The meter of claim 1, wherein the first communication interface is adapted to communicate information provided by at least one of the electrical circuitry and the memory device to an external device.

3. The meter of claim 2, wherein the first communication interface is adapted to include with the information communicated to the external device at least one determined analyte concentration.

4. The meter of claim 3, wherein the first communication interface is adapted to include with the information communicated to the external device an indication of whether the fluid sample for the determined analyte concentration was obtained from the first test site or the second test site.

5. The meter of claim 3, wherein the first communication interface is adapted to include with the information communicated to the external device a date and time stamp linked to each of the at least one determined analyte concentration.

6. The meter of claim 1, wherein the second communication interface is configured to communicate the determined test site via radio frequency.

7. The meter of claim 1, wherein the second communication interface is configured to communicate the determined test site via infra-red.

8. A sample collection system for obtaining a fluid sample, the sample collection system comprising:

a sample collection mechanism configured to selectively obtain the fluid sample;

a detection device with a sensor operatively connected to the sample collection mechanism and adapted to detect a characteristic of the sample collection mechanism, the detection device being adapted to determine, from the detected characteristic, whether the sample collection system is being used to obtain the fluid sample from a first test site or a second test site; and

a communication interface adapted to communicate wirelessly with a meter, the meter being adapted to determine an analyte concentration from the fluid sample, the communication interface being adapted to wirelessly communicate, from the sensor to the meter, whether the fluid sample was obtained from the first test site or the second test site, the meter including a memory device that is configured to store, in association with the analyte concentration, a marker indicating whether the fluid sample was obtained from the first test site or the second test site.

9. The sample collection system of claim 8, wherein the wireless communication interface is configured to communicate the determined test site wirelessly via radio frequency.

10. The sample collection system of claim 8, wherein the wireless communication interface is configured to communicate the determined test site wirelessly via infra-red.

11. The sample collection system of claim 8, wherein the sample collection mechanism includes a lancing mechanism with an endcap, a lance partially disposed in the endcap, and an adjustment mechanism for the lance, the adjustment mechanism being configured to adjust the depth that the lance extends from a face of the endcap, and wherein the detection device is configured to determine whether the fluid sample is from the first test site or the second test site by the sensor monitoring the adjustment mechanism.

12. The sample collection system of claim 8, wherein the sample collection mechanism includes a lancing mechanism with a lance, and the detection device is configured to determine whether the fluid sample is from the first test site or the second test site by the sensor detecting a distance that the lance extends from the lancing mechanism.

13. The sample collection system of claim 8, wherein the sample collection mechanism includes a lancing mechanism with first and second removable endcaps configured to obtain fluid samples from the first and second test sites, respectively, and the detection device is configured to determine whether the fluid sample is from the first test site or the second test site according to the sensor detecting whether the first removable endcap or the second removable endcap is attached to the lancing mechanism.

14. The sample collection system of claim 8, wherein the meter includes an input device configured to receive a manual entry from a user, the meter being configured to mark the analyte concentration as being from the first test site or the second test site according to the manual entry from the user.

15. A system for determining a concentration of an analyte in a fluid sample located on a test sensor, the system comprising:

a meter, including;

a memory device adapted to store information;

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

a first communication interface; and

a sample collection system adapted to obtain the fluid sample from a first test site or a second test site on a test subject, the sample collection system including;

a sample collection mechanism configured to selectively obtain the fluid sample;

a detection device with a sensor operatively connected to the sample collection mechanism and adapted to detect a characteristic of the sample collection mechanism, the detection device being adapted to determine whether the sample collection system is being used to obtain a fluid sample from the first test site or the second test site; and

a second communication interface adapted to communicate with the first communication interface of the meter, the second communication interface being configured to communicate, from the detection device to the first communication interface, whether the fluid sample was obtained from the first test site or the second test site,

wherein the memory device of the meter is configured to store, in association with the analyte concentration, a marker indicating whether the fluid sample was obtained from the first test site or the second test site.

16. The system of claim 15, wherein the second communication interface is configured to communicate the determined test site wirelessly via radio frequency.

17. The system of claim 15, wherein the second communication interface is configured to communicate the determined test site wirelessly via infra-red.

18. The system claim 15, wherein the first communication interface is adapted to communicate information provided by at least one of the electrical circuitry and the memory device to an external device.

19. The system of claim 18, wherein the first communication interface is adapted to include with the information communicated to the external device at least one determined analyte concentration.

20. The system of claim 19, wherein the first communication interface is adapted to include with the information communicated to the external device an indication of whether the fluid sample for the at least one determined analyte concentration was obtained from the first test site or the second test site.