Test element magazine having covered test fields

• US 8,734,365 B2
• Filed: 08/18/2011
• Issued: 05/27/2014
• Est. Priority Date: 02/19/2009
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Hoenes, Joachim
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US13/212,737
• Publication Number:
  US 20120039772A1
• Time in Patent Office: 1,013 Days
• Field of Search: 600/573, 600/575, 600/583, 600/584, 606/181, 606/182
• US Class Current: 600/584
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 2562/242 Packaging, i.e. for packaging the sensor or apparatus before use
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/15 Devices for taking samples of blood hypodermic syringes A61M5/178
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150503 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15115 Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
• 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 5/15151 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 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: B01L 2200/141 Preventing contamination, tampering
• CPC Class Codes: B01L 2300/0672 Integrated piercing tool
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

An analytic magazine is proposed, which comprises at least one chamber with at least one analytic aid. The analytic aid comprises at least one test element for detecting at least one analyte in a sample of a bodily fluid. The test element has at least one test field with at least one test chemical. The test field is at least partly arranged within the chamber, wherein at least one wall of the chamber at least partly covers the test field and at least partly delimits a test-field surface that is accessible from the chamber.

Claims

1. An analytic magazine, comprising at least one chamber with at least one analytic aid, wherein the analytic aid has at least one lancet, wherein the analytic aid furthermore comprises at least one test element for detecting at least one analyte in a sample of a bodily fluid, wherein the test element comprises at least one test field with at least one test chemical, wherein the test field is partly arranged within the chamber and is accessible for the sample of at least one of the bodily fluid and components of the sample from the chamber, wherein at least one wall of the chamber partly covers the test field and thereby delimits a test-field surface of the at least one test field having the at least one test chemical for placing the sample, which test-field surface is accessible from the chamber, wherein the test-field surface is delimited by virtue of the fact that the wall of the chamber lies directly on the test-field surface along one or more delimitation lines or lies in the vicinity of the test-field surface such that a region of the test-field surface that is not covered by the wall is accessible to the sample, but, by contrast, a region covered by the wall is not.

2. The analytic magazine according to claim 1, wherein the test field has at least one cutting edge, wherein the wall of the chamber at least partly covers the cutting edge.

3. The analytic magazine according to claim 1, wherein the wall of the chamber has at least one opening which provides limited access to the test field from the interior of the chamber.

4. The analytic magazine according to claim 1, wherein the lancet is at least partly held in the chamber, wherein the lancet is operable to hold a sample of a bodily fluid, wherein the analytic magazine is designed such that the lancet can transfer the held sample to the test field in at least one position.

5. The analytic magazine according to claim 4, wherein the lancet is movably mounted in the chamber, wherein the lancet describes an arced path during movement in the chamber, is subjected to a change in shape, or both.

6. The analytic magazine according to claim 4, wherein the lancet is mounted in a storage position within the chamber in a rest state, which storage position differs from the at least one position in which the held sample can be transferred to the test field.

7. An analytic magazine, comprising at least one chamber with at least one analytic aid, wherein the analytic aid comprises at least one test element for detecting at least one analyte in a sample of a bodily fluid, wherein the test element comprises at least one test field with at least one test chemical, wherein at least one membrane is arranged between the test field and an interior space of the chamber, wherein the membrane is at least partly permeable to the sample, wherein the membrane furthermore is at least partly impermeable to the test chemical such that an ingress of components of the test chemical into the chamber is substantially prevented, wherein solid chemical components with a size of more than 10 micrometers are held back, wherein the membrane is wholly or partly embodied as a porous material that is permeable to at least one of the sample and components of the sample, wherein the membrane lies directly on the test field such that no interspace, or an interspace of 5 μ

m or less, is produced between the test field and the membrane.

8. The analytic magazine according to claim 7, wherein the test field is at least partly covered by the membrane.

9. The analytic magazine according to claim 7, wherein the membrane has a mean pore dimension of between 1 μ

m and 10 μ

m.

10. The analytic magazine according to claim 7, wherein the membrane has a thickness of between 30 μ

m and 150 μ

m.

11. The analytic magazine according to claim 7, wherein the membrane has one or more of the following materials:

a cellulose, a polysulfone, a nylon, a polyvinylidene fluoride, a regenerated cellulose, and a hydrophilic polyurethane.

12. The analytic magazine according to claim 7, wherein the membrane has at least one structuring with at least one passage area, which is at least partly permeable to the sample of the bodily fluid, and with at least one impermeable area that is at least partly impermeable to the sample of the bodily fluid.

13. The analytic magazine according to claim 12, wherein the analytic magazine has a plurality of chambers, wherein the membrane has a common form for a number of chambers, and in each case provides at least one passage area for the number of chambers.

14. The analytic magazine according to claim 7, wherein the analytic magazine has a housing with at least one opening facing the chamber, wherein the membrane is applied to the opening from the outside and is accessible from the chamber through the opening.

15. The analytic magazine according to claim 14, wherein the membrane is connected to the housing by at least one connection, which comprises one or more of the following connections:

a welded joint or a connection produced by heat staking, an ultrasound welded joint, or a laser welded joint; and

a bonded connection.

16. The analytic magazine according to claim 14, wherein the test field is connected to the housing by at least one of a force-fit and an interlocking connection.

17. A method for producing an analytic magazine, wherein the analytic magazine comprises at least one chamber with at least one analytic aid, wherein the analytic aid comprises at least one test element for detecting at least one analyte in a sample of a bodily fluid, wherein the test element comprises at least one test field with at least one test chemical, wherein at least one lancet is introduced into the chamber, wherein the method furthermore comprises the following steps:

at least one housing part of a housing of the analytic magazine is produced;

the test field is produced; and

at least one of the test field and the test element is connected to the housing part such that the test field is partly accessible from the chamber for placing a sample, wherein at least one wall of the chamber partly covers the test field and thereby delimits a test-field surface of the at least one test field having the at least one test chemical that is accessible from the chamber, wherein the test-field surface is delimited by virtue of the fact that the wall of the chamber lies directly on the test-field surface along one or more delimitation lines or lies in the vicinity of the test-field surface such that a region of the test-field surface that is not covered by the wall is accessible to the sample, but, by contrast, a region covered by the wall is not.