Fluid handling methods

• US 20060000710A1
• Filed: 06/30/2004
• Published: 01/05/2006
• Est. Priority Date: 06/30/2004
• Status: Abandoned Application

• Current Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: Bohm, Sebastian, Moffat, James, Weidenhaupt, Klaus Peter
• Application Number:
  US10/883,477
• Publication Number:
  US 20060000710A1
• Time in Patent Office: Days
• US Class Current: 204/403.10
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• 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 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150274 Manufacture or production processes or steps for blood sampling devices
• 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 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• 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 5/150862 intermediate range, e.g. within room or building
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• 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 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6824 : Arm or wrist
• CPC Class Codes: B01L 2200/10 : Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/0645 : Electrodes
• CPC Class Codes: B01L 2400/0481 : squeezing of channels or chambers
• CPC Class Codes: B01L 3/502715 : characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/50273 : characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: F04B 43/043 : Micropumps
• CPC Class Codes: F04B 43/14 : having plate-like flexible members

Abstract

Devices for determining the concentration of an analyte in a fluid are provided. Also provided are systems and kits for use in practicing the subject methods.

Claims

1. A method of determining the concentration of an analyte in fluid, said method comprising:

contacting a device with a skin surface of a subject, wherein said device comprises;

at least one analyte sensing chamber,

a pumping chamber having a deflectable membrane, and

a skin piercing element;

introducing a volume of fluid from said subject, through said skin piercing element, to said pumping chamber; and

deflecting said membrane of said pumping chamber to transport said volume of fluid from said pumping chamber to said at least one analyte sensing chamber of said device to determine the concentration of an analyte in said volume of fluid.

2. The method of claim 1, wherein further comprising stopping the flow of said fluid at said at least one analyte sensing chamber.

3. The method of claim 2, wherein said analyte concentration determination is performed when said fluid is stopped.

4. The method of claim 1, wherein said analyte concentration determination is performed when said fluid is flowing.

5. The method of claim 1, wherein said analyte is glucose.

6. The method of claim 1, wherein said at least one sensing chamber is an electrochemical cell.

7. The method of claim 6, wherein said electrochemical cell comprises a redox reagent system.

8. The method of claim 1, wherein said at least one sensing chamber is an optical sensing chamber.

9. The method of claim 8, wherein said optical sensing chamber comprises a signal producing system.

10. The method of claim 1, further comprising receiving said device in a housing to provide electrical communication between said housing and said device.

11. The method of claim 10, wherein said housing is a user-retainable housing.

12. The method of claim 10, wherein said housing comprises an indicator, and said method comprises communicating results of said analyte concentration determination to said subject using said indicator.

13. The method of claim 10, wherein said housing comprises a controller for controlling said device.

14. The method of claim 13, further comprising providing communication between said controller and a remote controller.

15. The method of claim 19, wherein said communication is accomplished using a physical connection.

16. The method of claim 19, wherein said communication is accomplished wirelessly.

17. The method of claim 16, further comprising wirelessly communicating the results of said analyte concentration determination from said controller to said remote controller.

18. The method of claim 1, further comprising introducing an additional volume of fluid, from said subject, to said pumping chamber.

19. The method of claim 18, further comprising deflecting said membrane of said pumping chamber to transport said additional volume of fluid from said pumping chamber to said at least one analyte sensing chamber of said device to determine the concentration of an analyte in said additional volume of fluid.

20. The method of claim 19, wherein further comprising stopping the flow of said fluid at said at least one analyte sensing chamber.

21. The method of claim 20, wherein said analyte concentration determination is performed on said stopped fluid.

22. The method of claim 19, wherein said analyte concentration determination is performed on flowing fluid.

23. The method of claim 19, wherein said analyte is glucose.

24. A method of determining the concentration of an analyte in fluid, said method comprising:

maintaining a user-retainable housing comprising at least one analyte sensing chamber, a pumping chamber having a deflectable membrane, and a skin piercing element, in contact with a body part of a subject;

collecting fluid in said pumping chamber by drawing said fluid through said skin piercing element; and

deflecting said membrane of said pumping chamber to transport said collected fluid from said pumping chamber to said at least one analyte sensing chamber of said device to determine the concentration of an analyte in said volume of fluid.

25. The method of claim 24, wherein said fluid is continuously collected from said subject while said user-retainable housing is maintained in contact with said subject.

26. The method of claim 24, wherein said fluid is periodically collected from said subject while said user-retainable housing is maintained in contact with said subject.

27. The method of claim 24, further comprising communicating the results of said analyte concentration determination to remote location.

28. The method of claim 27, wherein said communicating is accomplished using a physical connection.

29. The method of claim 27, wherein said communicating is accomplished wirelessly.