Test strip device and method for analyzing a body fluid

• US 8,920,341 B2
• Filed: 04/09/2010
• Issued: 12/30/2014
• Est. Priority Date: 10/12/2007
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: List, Hans, Leichner, Wilhelm, Zimmer, Volker, Greuter, Matthias
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): DANEGA, RENEE A
• Application Number:
  US12/757,069
• Publication Number:
  US 20100286561A1
• Time in Patent Office: 1,726 Days
• Field of Search: 600/583, 436/44
• US Class Current: 600/583
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/15115 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 5/15169 Characterized by a rolled strip
• CPC Class Codes: A61B 5/15173 Characterized by propelling the piercing element parallel to the direction of movement of the strip
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: Y10T 436/110833 Utilizing a moving indicator strip or tape

Abstract

The invention concerns a test tape device for analyzing a body fluid having a carrier tape, a plurality of lancing elements arranged on the carrier tape which are provided with a tip that can puncture a body part and a collecting structure that takes up the body fluid obtained during the puncture, and test fields mounted on the carrier tape each being associated with a lancing element and can have body fluid applied thereto. According to the invention it is proposed that the lancing elements are each movably attached to the carrier tape by a coupling member and that a used lancing element can be brought into contact with a test field by a transfer movement from a usage position distant from a test field into a contact position so that body fluid can be transferred from the collecting structure onto the test field.

Claims

1. A test tape device for analyzing a body fluid for blood sugar tests having a carrier tape that can be wound onto or is wound onto a spool, a plurality of lancing elements arranged on the carrier tape which are provided with a tip that can puncture a body part and a collecting structure that takes up the body fluid obtained by the puncture, and test fields mounted on the carrier tape each being associated with a lancing element and can have body fluid applied thereto, characterized in that the lancing elements are each movably attached to the carrier tape by a coupling member, and that a used lancing element can be brought into fluidic connection with a test field by a transfer movement executed by the lancing element from a usage position distant from a test field into a contact position, so that body fluid is transferred directly from the collecting structure onto the test field, wherein each lancing element is covered in a sterile manner by a cover foil connected to the carrier tape to form a foil bag around each lancing element, wherein the lancing element is configured to puncture the cover foil, characterized in that the test fields have a reagent layer which is designed to detect an analyte in the body fluid.

2. The test tape device according to claim 1, characterized in that the orientation of the lancing elements relative to the carrier tape can be reversed by the transfer movement.

3. The test tape device according to claim 1, characterized in that the elongate lancing elements can be oriented in the longitudinal direction of the carrier tape at least in the contact position.

4. The test tape device according to claim 1, characterized in that the lancing elements can be contacted with an associated test field by a pivoting movement and in particular a folding movement.

5. The test tape device according to claim 1, characterized in that the lancing elements remain permanently connected to the tape by means of the coupling member during the transfer movement.

6. The test tape device according to claim 1, characterized in that the lancing elements are hinged on the carrier tape in a proximal region that is spaced apart from the tip by means of a joint or hinge as a coupling member.

7. The test tape device according to claim 1, characterized in that the lancing elements are pivotally connected to the carrier tape by means of a bending joint and in particular a film joint.

8. The test tape device according to claim 1, characterized in that the transfer movement of a lancing element can be triggered by advancing the carrier tape.

9. The test tape device according to claim 1, characterized in that the carrier tape is guided laterally past a retaining member and that the retaining member forms a stop obstacle for a lancing element which starts up during the tape transport preferably for folding down the lancing element.

10. The test tape device according to claim 9, characterized in that the retaining member is located in the area of a deflection point for the carrier tape and the tip of the lancing elements can be lifted from the carrier tape at the deflection point.

11. The test tape device according to claim 1, characterized in that the lancing elements are held at a deflection point for the carrier tape by a gripper in order to execute a lancing movement.

12. The test tape device according to claim 11, characterized in that the deflection point is arranged on a carriage that is also moved during the lancing movement.

13. The test tape device according to claim 1, characterized in that the carrier tape is guided past a holding-down device which is formed in particular by a leaf spring, wherein the holding-down device presses a lancing element which passes through against a test field.

14. The test tape device according to claim 1, characterized in that the carrier tape can be replaced as a single-use article preferably in the form of a tape cassette.

15. The test tape for insertion into a test tape device according to claim 1 preferably in the form of a replaceable tape cassette.

16. A method for analyzing a body fluid for blood sugar tests, comprising:

providing a plurality of lancing elements and associated test fields on a windable carrier tape, wherein the lancing elements are provided with a collecting structure, wherein the lancing element is covered by a foil holding each of the lancing elements in a movable manner on the carrier tape by means of a coupling member;

exposing the lancing element by piercing the foil with a tip of the lancing element, wherein said exposing includes deflecting the carrier tape at an acute angle on a deflection roller;

taking up the body fluid with the collecting structure of the lacing elements;

bringing one of the lancing elements into contact with one of the test fields by a transfer movement from a usage position that is distant from the test field into a contact position so that the body fluid is transferred directly from the collecting structure onto the test field; and

detecting an analyte in the body fluid with the test field.

17. The method of claim 16, further comprising:

wherein the collecting structure includes a capillary channel;

wherein the transfer movement includes folding down the lancing element to transfer the body fluid from the capillary channel onto the test field;

wherein the orientation of the lancing element relative to the carrier tape is reversed by the transfer movement; and

controlling the transfer movement by advancing the carrier tape.

18. The method of claim 17, further comprising:

pressing the lancing element against the carrier tape with a holding down device to intensify contact between the lancing element and the test field when at the contact position.

19. A test tape device for analyzing a body fluid for blood sugar tests having a carrier tape that can be wound onto or is wound onto a spool, a plurality of lancing elements arranged on the carrier tape which are provided with a tip that can puncture a body part and a collecting structure that takes up the body fluid obtained by the puncture, and test fields mounted on the carrier tape each being associated with a lancing element and can have body fluid applied thereto, characterized in that the lancing elements are each movably attached to the carrier tape by a coupling member, and that a used lancing element can be brought into fluidic connection with a test field by a transfer movement executed by the lancing element from a usage position distant from a test field into a contact position, so that body fluid is transferred directly from the collecting structure onto the test field, wherein each lancing element is covered in a sterile manner by a cover foil connected to the carrier tape to form a foil bag around each lancing element, wherein the lancing element is configured to puncture the cover foil, wherein a rear area of the foil bag is joined to a shaft of the lancing element and the carrier tape to form the coupling member, wherein the foil bag acts as a film joint to allow the lancing element to be folded against the test field.