Detection meter and mode of operation

• US 9,636,051 B2
• Filed: 06/08/2009
• Issued: 05/02/2017
• Est. Priority Date: 06/06/2008
• Status: Active Grant

• Current Assignee: Intuity Medical, Inc.
• Original Assignee: Intuity Medical, Inc.
• Inventors: Emery, Jeffrey L., Tomasco, Michael F., Hu, Charles
• Primary Examiner(s): SIEFKE, SAMUEL P
• Application Number:
  US12/457,331
• Publication Number:
  US 20100021947A1
• Time in Patent Office: 2,885 Days
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• 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 5/150396 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150809 by audible feedback
• 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 5/15163 Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A method for performing an assay to determine the presence or concentration of an analyte contained in a sample of body fluid by using a device comprising at least one analyte quantification member and a sensor associated therewith, the method includes: applying a first sample to the analyte quantification member; and detecting the presence or absence of an adequate sample volume; wherein upon detection of the absence of an adequate sample volume, initiating a finite timed period, and signaling the user to introduce a second sample of body fluid to the analyte quantification member. Associated arrangements and devices are also disclosed.

Claims

1. A device for performing an assay to determine the presence or concentration of an analyte contained in a sample of body fluid, the device comprising:

at least a first analyte quantification member;

at least one passageway in fluid communication with the first analyte quantification member;

a sensor configured to interrogate at least the first analyte quantification member and to detect the presence or absence of an adequate sample volume;

a vacuum source configured to assist in the expression of body fluid from a wound;

a non-transitory memory device programmed with instructions to;

activate the vacuum source;

initiate a first time period and interrogate the first analyte quantification member using the sensor to detect the presence or absence of an adequate sample volume applied to the first analyte quantification member within the first time period; and

upon the detection of the absence of an adequate sample volume, initiate a second time period and signal a user to manually milk the wound and introduce an additional sample of body fluid into the at least one passageway to increase the sample volume applied to the first analyte quantification member; and

a processor programmed to carry out the instructions on the non-transitory memory device.

2. The device of claim 1, wherein the non-transitory memory device further comprises programmed instructions to interrogate the first analyte quantification member using the sensor during the second time period to detect the presence or absence of an adequate sample volume.

3. The device of claim 2, wherein the non-transitory memory device further comprises programmed instructions to signal the user that the assay is being terminated upon detection of the absence of an adequate sample volume within the second time period.

4. The device of claim 2, wherein the non-transitory memory device further comprises programmed instructions to continue with the assay upon detection of an adequate sample volume during the second time period.

5. The device of claim 4, wherein the non-transitory memory device further comprises programmed instructions to interrogate the first analyte quantification member using the sensor subsequent to the second time period to ascertain the presence or concentration of the analyte.

6. The device of claim 1, wherein the analyte comprises glucose and the body fluid comprises blood.

7. The device of claim 1, wherein the first analyte quantification member comprises an assay pad containing a chemical reagent formulated to produce a color change upon reaction with the analyte.

8. The device of claim 1, wherein the device comprises a plurality of the analyte quantification members.

9. The device of claim 8, wherein the device comprises a removable cartridge containing the plurality of the analyte quantification members.

10. The device of claim 7, wherein the sensor comprises an optical sensor configured to produce signals indicative of the color change.

11. The device of claim 1, wherein the second time period is less than 1 minute.

12. The device of claim 11, wherein the second time period is 45 seconds or less.

13. The device of claim 1, wherein the signal comprises at least one of a visual signal and an audible signal.

14. The device of claim 1, further comprising at least one skin-penetration member.

15. The device of claim 8, further comprising a plurality of skin-penetration members, wherein each of the plurality of analyte quantification members has a respective skin-penetration member associated therewith.

16. The device of claim 14, wherein the at least one skin-penetration member comprises a needle having an inner lumen, and the at least one passageway comprises the inner lumen of the needle.

17. The device of claim 15, further comprising a removable cartridge containing the plurality of analyte quantification members and the plurality of skin-penetration members.

18. The device of claim 14, wherein the non-transitory memory device further comprises programmed instructions to activate the vacuum source prior to, during, or subsequent to piercing the skin with the at least one skin-penetration member.

19. The device of claim 1, wherein an anticoagulant material is provided on at least a portion of the passageway.

20. The device of claim 16, wherein an anticoagulant material is provided on at least a portion of the inner lumen.

21. The device of claim 1, further comprising a skin interface member and a skin-penetration member, wherein at least one of the skin interface member and the skin-penetration member comprises a guide element configured to guide a flow of body fluid in a desired direction toward a desired location.

22. The device of claim 21, wherein both the skin interface member and the skin-penetration member comprise a guide element.

23. The device of claim 18, wherein the non-transitory memory device comprises programmed instructions to activate the vacuum source prior to piercing the skin with the at least one skin-penetration member.

24. The device of claim 14, wherein the non-transitory memory device further comprises programmed instructions to drive the skin-penetration member into skin of the user to form the wound.

25. The device of claim 1, wherein the non-transitory memory device further comprises instructions to deactivate the vacuum source.