TEST STRIP DEVICE AND METHOD FOR ANALYZING A BODY FLUID

• US 20110282244A9
• Filed: 04/09/2010
• Published: 11/17/2011
• Est. Priority Date: 10/12/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Greuter, Matthias, List, Hans, Leichner, Wilhelm, Zimmer, Volker
• Granted Patent: US 8,920,341 B2
• Time in Patent Office: Days
• 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 (36), a plurality of lancing elements (12) arranged on the carrier tape (36) which are provided with a tip (40) that can puncture a body part and a collecting structure (44) that takes up the body fluid obtained during the puncture, and test fields (14) mounted on the carrier tape (36) each being associated with a lancing element (12) and can have body fluid applied thereto. According to the invention it is proposed that the lancing elements (12) are each movably attached to the carrier tape (36) by a coupling member (38) and that a used lancing element (12) can be brought into contact with a test field (14) by a transfer movement from a usage position distant from a test field (14) into a contact position so that body fluid can be transferred from the collecting structure (44) onto the test field (14).

Claims

1. Test tape device for analyzing a body fluid especially for blood sugar tests having a carrier tape (36) that can be wound onto or is wound onto a spool (18, 20), a plurality of lancing elements (12) arranged on the carrier tape (36) which are provided with a tip (40) that can puncture a body part and a collecting structure (44) that takes up the body fluid obtained by the puncture, and test fields (14) mounted on the carrier tape (36) each being associated with a lancing element (12) and can have body fluid applied thereto, characterized in that the lancing elements (12) are each movably attached to the carrier tape (36) by a coupling member (38), and that a used lancing element (12) can be brought into fluidic connection with a test field (14) by a transfer movement executed by the lancing element from a usage position distant from a test field (14) into a contact position, so that body fluid is transferred directly from the collecting structure (44) onto the test field (14).

2. Test tape device according to claim 1, characterized in that the orientation of the lancing elements (12) relative to the carrier tape (36) can be reversed by the transfer movement.

3. Test tape device according to claim 1 or 2, characterized in that the elongate lancing elements (12) can be oriented in the longitudinal direction of the carrier tape (36) at least in the contact position.

4. Test tape device according to one of the claims 1 or 3, characterized in that the lancing elements (12) can be contacted with an associated test field (14) by a pivoting movement and in particular a folding movement.

5. Test tape device according to one of the claims 1 to 4, characterized in that the lancing elements (12) remain permanently connected to the tape by means of the coupling member (38) during the transfer movement.

6. Test tape device according to one of the claims 1 to 5, characterized in that the lancing elements (12) are hinged on the carrier tape (36) in a proximal region that is spaced apart from the tip (40) by means of a joint or hinge as a coupling member (38).

7. Test tape device according to one of the claims 1 to 6, characterized in that the lancing elements (12) are pivotally connected to the carrier tape (36) by means of a bending joint and in particular a film joint.

8. Test tape device according to one of the claims 1 to 7, characterized in that the lancing elements (12) are covered in a preferably sterile manner on the carrier tape (36) by a foil or foil bag (46) where the foil or foil bag is peii ianently connected to the carrier tape (36) and to a proximal section of the respective lancing element (12).

9. Test tape device according to one of the claims 1 to 8, characterized in that the test fields (14) have a reagent layer which is designed to detect an analyte in the body fluid.

10. Test tape device according to one of the claims 1 to 9, characterized in that the transfer movement of a lancing element (12) can be triggered by advancing the carrier tape (36).

11. Test tape device according to one of the claims 1 to 10, characterized in that the carrier tape (36) is guided laterally past a retaining member (48) and that the retaining member (48) forms a stop obstacle for a lancing element (12) which starts up during the tape transport preferably for folding down the lancing element.

12. Test tape device according to one of the claims 1 to 11, characterized in that the retaining member (48) is located in the area of a deflection point (22) for the carrier tape (36) and the tip (40) of the lancing elements (12) can be lifted from the carrier tape (36) at the deflection point (22).

13. Test tape device according to one of the claims 1 to 12, characterized in that the lancing elements (12) are held at a deflection point (22) for the carrier tape (36) by a gripper (32) in order to execute a lancing movement.

14. Test tape device according to one of the claims 1 to 13, characterized in that the deflection point (22) is arranged on a carriage (30) that is also moved during the lancing movement.

15. Test tape device according to one of the claims 1 to 14, characterized in that the carrier tape (36) is guided past a holding-down device (50) which is formed in particular by a leaf spring, wherein the holding-down device (50) presses a lancing element (12) which passes through against a test field (14).

16. Test tape device according to one of the claims 1 to 15, characterized in that the carrier tape (36) can be replaced as a single-use article preferably in the form of a tape cassette (24).

17. Test tape (16) for insertion into a test tape device according to one of the previous claims preferably in the form of a replaceable tape cassette (24).

18. Method for analyzing a body fluid in particular for blood sugar tests in which a plurality of collecting elements (12) and associated test fields (14) are provided on a windable carrier tape (36) wherein the collecting elements (12) are provided with a collecting structure (44) which takes up a body fluid and body fluid from the collecting structure (44) is applied to the test fields in order to detect an analyte in the body fluid, characterized in that the lancing elements (12) are each held in a movable manner on the carrier tape (36) by means of a coupling member (38), and that the collecting elements (12) are brought into contact with a test field (14) by a transfer movement from a usage position that is distant from a test field (14) into a contact position so that body fluid is transferred from the collecting structure (44) onto the test field (14).