Body fluid sampling device

• US 8,369,918 B2
• Filed: 06/23/2011
• Issued: 02/05/2013
• Est. Priority Date: 03/06/2004
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Calasso, Irio G., Griss, Patrick, Sarofim, Emad, Jaeggi, Rainer, Kraemer, Uwe, Hasker, David, Zimmer, Volker
• Primary Examiner(s): D'ANGELO, MICHAEL J
• Application Number:
  US13/167,243
• Publication Number:
  US 20110257493A1
• Time in Patent Office: 593 Days
• Field of Search: 600325-327, 600/345, 600/347, 600/348, 600/354, 600/573, 600/575, 600/576, 600/577, 600/578, 600583-584
• US Class Current: 600/345
• 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 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• CPC Class Codes: A61B 5/150297 for piercing devices, i.e. devices ready to be used for lancing or piercing for piercing elements A61B5/150282, for driving devices A61B5/15029
• 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 5/150435 Specific design of proximal end
• 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 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap

Abstract

Body fluid sampling device comprising a sampling element having a fluid pathway (11) for receiving body fluid, at least a portion of the fluid pathway is open to the environment and further comprising a fluid receiving means (40) being spaced from the fluid pathway so that fluid in the pathway will not contact the fluid receiving means initially. The fluid receiving means has two or more test zones (45) for performing analytical reactions. Fluid from the channel is contacted with the fluid receiving means either by bringing the fluid receiving means and the fluid into mechanical contact or by electrically transporting fluid from the channel onto the fluid receiving means.

Claims

1. A method for determining an analyte concentration in body fluid comprising the steps of:

a) receiving body fluid in a fluid pathway of a sampling element,

b) providing a fluid receiving means having two or more test zones,

c) moving at least one of the sampling element and the fluid receiving means after said receiving body fluid so that the sampling element and the fluid receiving means contact one another and body fluid from the fluid pathway of the sampling element contacts said two or more test zones while a fluid bolus first entering the fluid pathway is not contacted with the test zones,

d) receiving signals from said at least one test zone which are characteristic for an analyte concentration, and

e) providing a detection unit for processing said signals to determine an analyte concentration.

2. The method according to claim 1, wherein a time period beginning with step c) is monitored and determination of analyte concentration is initiated based on the time passed.

3. The method according to claim 1, wherein step c) initiates a monitoring of signals and the change of signal over time is employed to determine a point in time for concentration determination.

4. The method according to claim 1, comprising pricking skin with said skin piercing element.

12. The method according to claim 1, wherein said contacting includes contacting the two or more test zones with the fluid pathway in a tilted manner.

5. A method for determining an analyte concentration in body fluid comprising the steps of:

a) receiving body fluid in a fluid pathway of a sampling element,

b) moving at least one of the sampling element or a first test zone to contact the sampling element with the first test zone so that body fluid from the fluid pathway of the sampling element contacts the first test zone, wherein said contacting occurs at an intermediate portion of the fluid pathway so that a fluid bolus first entering the fluid pathway is not contacted with the first test zone,

c) simultaneously contacting the sampling element with a second test zone so that body fluid from the fluid pathway of the sampling element simultaneously contacts the second test zone,

d) receiving signals from the two test zones, and

e) providing a detection unit for processing said signals to determine analyte concentrations.

6. A body fluid testing device, comprising:

a sampling element defining a fluid channel, the fluid channel including a laterally open portion with a length, the laterally open portion having an open side along its length;

a test section with at least two test zones for testing body fluid; and

a moveable section connected to the sampling element and the test section, the moveable section being moveable from a first condition with the laterally open portion of the fluid channel and the test section being out of fluidic contact with one another wherein the laterally open portion of the fluid channel cannot contact the test section to a second condition with the laterally open portion of the fluid channel and the test section being in fluidic contact with one another wherein the laterally open portion of the fluid channel contacts the test section.

7. The body fluid testing device of claim 6, with the sampling element further including a skin piercing tip in fluidic contact with the fluid channel.

8. The body fluid testing device of claim 7, with the fluid channel having a fluid introduction region near said skin piercing tip and upstream from the laterally open portion, and a discharge region downstream from the laterally open portion.

9. The body fluid testing device of claim 6, further comprising a bendable portion attached to the moveable section, the bendable portion being configured and adapted to bend as the moveable section moves from the first condition to the second condition.

10. The body fluid testing device of claim 6, wherein the fluid channel and the test section contact one another in an angled manner when the moveable section is in the second condition.

11. The body fluid testing device of claim 6, wherein the moveable section is moveable to simultaneously place the two test zones in fluidic contact with the laterally open portion of the fluid channel when moving from the first condition to the second condition.