Blood glucose measurement for small blood volume

• US 9,326,718 B2
• Filed: 07/28/2010
• Issued: 05/03/2016
• Est. Priority Date: 01/28/2008
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Petrich, Wolfgang, Vrancic, Christian, Wong, Daniel, Patel, Paul
• Primary Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US12/845,512
• Publication Number:
  US 20110125059A1
• Time in Patent Office: 2,106 Days
• Field of Search: 600/583, 600/584, 606/181, 606/182
• 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 5/150022 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 5/150152 by an adequate mechanical impact on the puncturing location
• 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 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• 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 5/150816 by tactile feedback, e.g. vibration
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150954 Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
• CPC Class Codes: A61B 5/15109 Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• 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 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A system is proposed for detection of at least one analyte in a body fluid, in particular for detection of blood glucose. The system is designed to generate a sample of the body fluid and to transfer at least some of the sample to at least one test element, in particular a test panel. The system is designed such that a time period between the generation of the sample and the application to the test element is less than 1 second, preferably less than 500 ms.

Claims

1. A system for detecting at least one analyte in a body fluid, the system comprising:

at least one test element comprising a test panel configured to detect the at least one analyte;

at least one lancet configured to generate a body fluid sample of less than 1 μ

l;

an actuator configured to incite the at least one lancet;

at least one transfer device configured to transfer a whole or partial volume of the body fluid sample generated by the at least one lancet to the at least one test element in a transfer time of less than 1 second; and

a measurement device configured to detect the at least one analyte, configured to detect an actual sample volume of the body fluid sample generated by the at least one lancet including a volume of the body fluid sample transferred to the at least one test element, configured to correct a measured value of the at least one analyte taking into account the actual sample volume, and configured to at least partially compensate changes in concentration to the measured value of the at least one analyte taking into account evaporation effects dependent on sample volume, wherein the measurement device comprises at least one sensor for detecting the actual sample volume.

2. The system of claim 1, wherein the transfer device comprises at least one capillary, the at least one lancet comprising at least partially a capillary, the at least one lancet comprising a partially opened capillary, or the at least one lancet comprising a wholly or partially integrated capillary and a wholly or partially integrated at least one test element.

3. The system of claim 2, wherein the transfer device is the at least one lancet comprising the wholly or partially integrated capillary and the wholly or partially integrated at least one test element.

4. The system of claim 2, wherein the transfer device comprises at least one hydrophilic coating.

11. The system of claim 1, wherein the transfer device is configured such that the transfer time between the generation of the body fluid sample and the application to the at least one test element is selected to be one of less than 800 ms, less than 500 ms, less than 200 ms, and 100 ms.

13. The system of claim 1, wherein the at least one test element is connected to the at least one transfer device, and wherein the transfer time includes a collection time for pickup of the body fluid sample by the at least one transfer device and a transport time for transfer of the body fluid sample to the at least one test element.

5. A system for detecting at least one analyte in a body fluid, the system comprising:

at least one test element comprising a test panel configured to detect the at least one analyte;

at least one lancet configured to generate a body fluid sample of less than 1 μ

l;

an actuator configured to incite the at least one lancet;

at least one capillary configured to transfer a whole or partial volume of the body fluid sample generated by the at least one lancet to the at least one test element in a transfer time of less than 1 second, wherein the at least one capillary has a ratio of fillable capillary length to capillary diameter of less than 100; and

a measurement device configured to detect the at least one analyte, configured to detect an actual sample volume of the body fluid sample generated by the at least one lancet including a volume of the body fluid sample transferred to the at least one test element, configured to correct a measured value of the at least one analyte taking into account the actual sample volume, and configured to at least partially compensate changes in concentration to the measured value of the at least one analyte taking into account evaporation effects dependent on the actual sample volume, wherein the measurement device comprises at least one sensor for detecting the actual sample volume.

6. The system of claim 5, wherein the sample the sample volume of the body fluid sample is greater than 10 nl but less than 500 nl.

7. The system of claim 6, wherein the sample volume of the body fluid sample is selected to be one of less than 300 nl, less than 200 nl, and less than 100 nl.

14. The system of claim 5, wherein the at least one test element is connected to the at least one capillary, and wherein the transfer time includes a collection time for pickup of the body fluid sample by the at least one capillary and a transport time for transfer of the body fluid sample to the at least one test element.

8. A system for detecting at least one analyte in a body fluid, the system comprising:

at least one test element comprising a test panel configured to detect the at least one analyte;

at least one lancet configured to generate a body fluid sample of less than 1 μ

l;

an actuator configured to incite the at least one lancet;

at least one transfer device configured to transfer a whole or partial volume of the body fluid sample generated by the at least one lancet to the at least one test element in a transfer time of less than 1 second;

a measurement device configured to detect the at least one analyte and configured to at least partially compensate changes in concentration to a measured value of the at least one analyte taking into account sample evaporation effects on the volume of the body fluid sample, wherein the measurement device comprises at least one sensor for detecting moisture during body fluid sample generating and transferring; and

a housing having an interior and at least one opening, wherein the at least one test element, at least one lancet, the actuator, the at least one transfer device and the measurement device are within the interior of the housing, wherein a skin part can be placed wholly or partially in the opening to at least partially close the opening, and wherein the body fluid sample is generated in the skin part placed in the at least one opening.

9. The system of claim 8, wherein the measurement device is further configured to at least temporarily interrupt the detection of the at least one analyte and/or generate a warning when a predefined minimum humidity is undershot.

10. The system of claim 8, wherein the measurement device is further configured to detect at least one further parameter within the housing during the generation of the body fluid sample and transfer to the at least one test element, and to take the at least one further parameter into account in the detection of the at least one analyte in the body fluid sample.

12. The system of claim 8, wherein the ait least one transfer device is at least one capillary having a ratio of fillable capillary length to capillary diameter of less than 100.

15. The system of claim 8, wherein the at least one test element is connected to the at least one transfer device, and wherein the transfer time includes a collection time for pickup of the body fluid sample by the at least one transfer device and a transport time for transfer of the body fluid sample to the at least one test element.