Sample capture in one step for test strips

• US 20120238841A1
• Filed: 04/14/2011
• Published: 09/20/2012
• Est. Priority Date: 04/15/2010
• Status: Abandoned Application

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Perry, Jeffrey, Shoup, Thomas, Castle, Mark, Kugizaki, Rodney
• Application Number:
  US13/086,453
• Publication Number:
  US 20120238841A1
• Time in Patent Office: Days
• US Class Current: 600/316
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• 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 5/14546 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 5/150167 Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150213 Venting means
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• 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 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• 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 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15161 : Characterized by propelling the piercing element in a radial direction relative to the disc
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood

Abstract

A test strip is provided with sample capture that provides for a one step process to achieve a lancing event, sample capture and sample transport in a sensor design that supports one step testing. In various embodiments, the present invention provides for one step testing by, (i) analyte sample capture layout; (ii) analyte sample capture and transport configurations; (iii) structures of sample capture; (iv) processes for forming sample transport, and the like.

Claims

1. A test strip device, comprising:

a first substrate with a first electrode;

a second substrate with a second electrode, with a fluid passage way between the first and second substrates;

a spacer layer that includes an aperture coupled to the fluid passage way and positioned between the first and second electrodes;

a reaction zone/sensor formed between the first and second electrodes; and

a hydrophilic sample collection structure.

2. The strip device of claim 1, wherein the sample collection structure includes, at least one of, a micro sponge, a hydrophilic layer, an annular capillary surrounding the lancing needle/wound;

and a hydrophobic coating on the outside facing surface of the cover film, with the sample capture structure surrounds the lancing wound site.

3. A test strip device for testing a biologic analyte obtained by lancing a finger, comprising:

an aperture in the test strip providing a path for a penetrating member;

a sample-capture feature;

a sample-collection feature, and a transport pathway to move the analyte to a specified portion of the test strip for reaction with a reagent and measurement of the reaction products.

4. The device of claim 3, wherein the sample-capture feature includes an aperture providing a penetrating member path, a structure which substantially surrounds the penetrating member wound in close proximity to the wound, and a hydrophobic area to prevent unwanted wetting by the analyte.

5. The device of claim 4, wherein the sample-capture feature is shaped in a non-planar way to maximize the ratio of the area of the sample-capture feature to the area of the skin surrounded by the sample-capture feature.

6. The device of claim 3, wherein the sample-collection feature includes a micro-fluidic micro-sponge which is hydrophilic for the analyte and substantially surrounds the penetrating member wound in close proximity to the wound, and a hydrophobic area to prevent unwanted wetting by the analyte.

7. The device of claim 6, wherein the sample-collection feature can capture a sample of analyte between 100 nano liters and 5,000 nano liters.

8. The device of claim 3, wherein the transport pathway includes a micro-fluidic channel from the sample-collection and sample-capture features to a specified portion of the strip.

9. The device of claim 3, further comprising:

a detection mechanism is integrated into one or more of the sample collection, sample capture and sample transport features to detect the proper and/or improper supplying of sample to the test strip in which the sample-collection and sample-capture features substantially surround said indentation.

10. A test strip device, comprising:

an aperture in the test strip providing a path for a penetrating member;

a sample-capture feature;

a sample-collection feature; and

a transport pathway created by covering the substrate of the test strip with a cover layer which provides a two-dimensional capillary area over which the analyte spreads automatically by means of capillary forces and in which reagent exists within said capillary area which reacts with the analyte such that the optical properties of the two-dimensional capillary area are changed in proportion to the concentration of the analyte and measurement of said concentration is by optical reflectance, transmission, or fluorescence.

11. A test strip device, comprising:

an aperture in the test strip providing a path for the penetrating member;

a sample-capture feature; and

a sample-collection feature in which the sample-collection feature is at least one of, a micro-fluidic hydrophilic structure containing reagent which reacts with an analyte.

12. The device of claim 11, wherein products of the reaction are measured optically.

13. The device of claim 11, wherein products of the reaction are measured electrically by at least one of, voltage, charge, and current.