Analysis System and Method for Determining an Analyte in a Body Fluid With a Magazine Comprising Integrated Sample Acquisition and Analyzing Elements

• US 20110060246A1
• Filed: 02/25/2010
• Published: 03/10/2011
• Est. Priority Date: 08/31/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Frey, Stephan-Michael, Fluegge, Kai, List, Hans
• Granted Patent: US 8,888,715 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/1405 Devices for taking blood samples devices for taking samples of other body liquids A61B10/0045
• 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 5/150435 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 5/150572 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 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• 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 5/15174 Piercing elements stocked in the form of a stack or pile
• CPC Class Codes: A61B 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

Analysis system for determining an analyte in a body fluid is presented. The system comprises a reusable analysis instrument and a magazine having a plurality of integrated sample acquisition and analyzing elements. Each element comprises a puncturing element and an analyzing element. A coupling unit couples the integrated sample acquisition and analyzing element to a drive. The magazine comprises a housing having a plurality of elongate neighboring chambers separated by two side walls running in a longitudinal. The chambers contain the integrated sample acquisition and analyzing element. The chambers have an exit opening allowing for the at least partial exiting of the puncturing element. The chambers of the magazine are accessible to a coupling element that can be formfitting coupled to the coupling structure of the puncturing element, when the puncturing element is in the chamber of the magazine and the magazine is located in a holder.

Claims

1. An analysis system for determining an analyte in a body fluid, the system comprising

a magazine comprising a plurality of integrated sample acquisition and analyzing elements, each element comprises a puncturing element, an analyzing element and two major surfaces, the magazine comprising,

a plurality of elongate neighboring chambers separated by side walls running in a longitudinal direction of the plurality of elongate neighboring chambers having a height and length greater than their width, wherein the width is defined as the distance between two neighboring side walls, wherein the plurality of elongate neighboring have two major sides delimited by the side walls and two long sides and two short minor sides extending between the side walls, wherein each chamber contains an integrated sample acquisition and analyzing element, wherein the puncturing element of the integrated sample acquisition and analyzing element has a coupling structure movable on a movement path of a puncture movement in a puncturing direction, and wherein each chamber has an exit opening on one of its minor sides for an at least partial exiting of the chamber by the puncturing element moving on the movement path;

and

a reusable analysis instrument, the analysis instrument comprises,

a drive for driving the puncturing element in the movement path of the puncture movement, wherein the puncture movement includes a propulsion phase in the puncturing direction and, after reaching a reversal point, a retraction phase opposite to the puncturing direction,

a coupling unit coupling the integrated sample acquisition and analyzing element to the drive, wherein the coupling unit has a coupling element

a measuring and evaluation unit for measuring a measurement variable characteristic of the analyte and for deriving therefrom a desired analysis result;

a magazine holder for holding the magazine;

wherein the plurality of elongate neighboring are accessible by the coupling element on one of their long minor sides such that the coupling element can be formfitting coupled to the coupling structure of the puncturing element, when the puncturing element is positioned in the chamber and the magazine is located in the holder.

2. The analysis system according to claim 1, wherein the measuring and evaluation unit comprises an optical measuring apparatus for measuring an optically measurable measuring variable characteristic of the analyte.

3. The analysis system according to claim 1, wherein the analysis instrument further comprises a contact pressure unit that presses the puncturing element against the analyzing element.

4. The analysis system according to claim 3, wherein the magazine is advanced using the contact pressure unit.

5. The analysis system according to claim 1, wherein the plurality of elongate neighboring chambers are covered with a film on the long minor side on which the elongate neighboring chambers are accessible and/or on the short minor side in which the exit openings of the elongate neighboring chambers are located.

6. The analysis system or magazine according to claim 1, wherein the analyzing element of the integrated sample acquisition and analyzing element has a second coupling structure to which the coupling unit of the analysis instrument can be formfitting coupled.

7. The analysis system according to claim 6, wherein the coupling structure of the puncturing element and/or the second coupling structure of the analyzing element are located on an elongated minor side of the puncturing element and/or the analyzing element, respectively, such that the coupling unit of the analysis instrument can be formfitting coupled to the coupling structure and such that the puncturing element and the analyzing element are movable relative to another.

8. The analysis system according to claim 1, wherein,

the analyzing element has a test field zone,

the puncturing element has a capillary channel having at least one sample inlet and one sample outlet, and

the movement path of the puncturing element has a transfer position, in which the puncturing element is located relative to the analyzing element in such a position that the sample outlet of the capillary channel of the puncturing element neighbors the test field zone of the analyzing element so that a transfer of a body fluid from the capillary channel onto the test field zone can take place.

9. The analysis system according to claim 1, wherein the integrated sample acquisition and analyzing element comprises a spacer element located between the analyzing element and the puncturing element such that the puncturing element on its movement path at least in the puncturing direction passes a test field zone of the analyzing element without contacting the test field zone.

10. The analysis system according to claim 1, wherein the integrated sample acquisition and analyzing element is movable in the puncturing direction into an operational position such that the integrated sample acquisition and analyzing element at least partially extends out of the exit opening and that a test field zone of the analyzing element is positioned outside the chamber.

11. The analysis system according to claim 1, wherein the puncturing element is enclosed by a protective envelope, the protective envelope is connected to the puncturing element and to the analyzing element and is telescoped upon a relative movement of the puncturing element relative to the analyzing element in the puncturing direction, wherein a tip of the puncturing element penetrates the protective envelope and extends out of the protective envelope.

19. Integrated sample acquisition and analyzing element, as a component of an analysis system according to claim 1, having two flat sides and comprising an analyzing element and a puncturing element having a tip, wherein,

the puncturing element is movable on a movement path of a puncture movement in the puncturing direction and in relation to the analyzing element, the puncturing element is enclosed by a protective envelope, the protective envelope is connected to the puncturing element and the analyzing element and is telescoped upon a relative movement of the puncturing element in relation to the analyzing element in the puncturing direction, wherein the tip of the puncturing element penetrates the protective envelope and extending out of the protective envelope.

20. Integrated sample acquisition and analyzing element according to claim 19, wherein the puncturing element has a coupling structure to which a coupling unit of the analysis instrument can be coupled for moving the puncturing element on its movement path relative to the analyzing element.

12. A magazine for an analysis instrument, the magazine comprises:

a plurality of flat, elongate, disposable integrated sample acquisition and analyzing elements, wherein each flat, elongate, disposable integrated sample acquisition and analyzing element comprises a puncturing element and an analyzing element and have two flat sides, wherein

a housing comprising a plurality of elongate neighboring chambers, wherein the plurality of elongate neighboring chambers are separated by two side walls running in a longitudinal direction of the plurality of elongate neighboring chambers having a height and length greater than the distance of two neighboring side walls, wherein the plurality of elongate neighboring chambers have two major sides delimited by the side walls and two long and two short minor sides extending between the side walls, wherein each chamber comprises an integrated sample acquisition and analyzing element, wherein the puncturing element of the integrated sample acquisition and analyzing element has a coupling structure movable on a movement path of a puncture movement in a puncturing direction, and wherein each chamber has an exit opening on one of its minor sides for an at least partial exiting of the chamber by the puncturing element moving on the movement path and wherein analyzing element of the integrated sample acquisition and analyzing element has a second coupling structure, wherein each chamber has an exit opening on one of its minor sides for an at least partial exiting of the chamber by the puncturing element moving on the movement path, wherein the plurality of elongate neighboring chambers are accessible by the coupling element on one of their long minor sides such that the coupling element of a coupling unit of the analysis instrument can be formfitting coupled to the coupling structure of the puncturing element and that another coupling unit can be formfitting coupled to the coupling structure of the analyzing element, wherein the puncturing element and the analyzing element are movable relative to another such that the puncturing element is movable in a transfer position relative to the analyzing element to transfer body fluid.

13. A magazine for an analysis instrument having a plurality of flat, elongate, disposable integrated sample acquisition and analyzing elements, wherein the plurality of flat, elongate, disposable integrated sample acquisition and analyzing elements comprise a puncturing element and an analyzing element and having two flat sides, wherein

the magazine includes a plurality of neighboring chambers,

each chamber contains an integrated sample acquisition and analyzing element, wherein the puncturing element of the integrated sample acquisition and analyzing element is enclosed by a protective envelope and is movable on a movement path of a puncture movement in a puncturing direction,

each chamber has an exit opening allowing an at least partial exiting of the chamber by of the integrated sample acquisition and analyzing element, and

the plurality of neighboring chambers are covered with a film on at least one of their sides such that the plurality of neighboring chambers are completely closed.

14. The magazine according to claim 13, wherein the plurality of neighboring chambers, are elongated,

are separated by two side walls running in a longitudinal direction of the plurality of neighboring chambers having a height and length greater than the distance of two neighboring side walls,

have two major sides delimited by the side walls and two long and two short minor sides extending between the side walls, wherein the exit opening is positioned on one of their minor sides, and

are covered with a film on the long minor side, on one of their minor sides, on the short minor side, on the major side, or combinations thereof.

15. The magazine according to claim 14, wherein the film covering the plurality of neighboring chambers on their long minor side can be penetrated by a coupling element of a coupling unit of the analysis instrument.

16. The magazine according to claim 13, wherein the puncturing element has a coupling structure, wherein the plurality of neighboring chambers are accessible on one of their long minor side such that a coupling element of a coupling unit of the analysis instrument can be formfitting coupled to the coupling structure of the puncturing element.

17. The magazine according to claim 13, wherein the film for covering the minor sides of the plurality of neighboring chambers is at least partially metallic.

18. The magazine according to claim 13, wherein the film covering the exit opening can be penetrated by the integrated sample acquisition and analyzing element and/or by the puncturing element on the movement path in the puncturing direction.

21. A method for generating a wound in a body part and for analyzing a body fluid exiting from the wound, the method comprising:

using an analysis system, the analysis system comprising,

a magazine that includes a plurality of flat, disposable, integrated sample acquisition and analyzing elements, each element comprises a puncturing element, an analyzing element and two major surfaces, wherein the magazine comprises,

a housing having a plurality of elongate neighboring chambers, wherein each chamber contains the integrated sample acquisition and analyzing element, the analyzing element of the integrated sample acquisition and analyzing element has a test field zone and a coupling structure, and wherein the chambers are accessible such that a coupling element of a coupling unit of the analysis instrument can be formfitting coupled to the analyzing element, and

a reusable analysis instrument, the analysis instrument comprising a drive, the coupling unit having the coupling element for coupling the analyzing element of an integrated sample acquisition and analyzing element to the drive, a measuring and evaluation unit for optical measurement of a measuring variable characteristic for the determination of an analyte and for deriving a desired analysis result, and a holder for holding the magazine;

formfitting coupling of the coupling element to the coupling structure of the analyzing element;

moving the analyzing element in a puncturing direction into an operational position, in which the analyzing element extends at least partially out of the chamber such that the test field zone of the analyzing element is positioned outside the magazine; and

measuring a measurement variable characteristic of an analyte on the test field zone.

22. The method according to claim 21, wherein the coupling unit has a second coupling element, wherein the puncturing element has a coupling structure and a capillary channel having at least one sample inlet and one sample outlet, further comprising:

moving the puncturing element synchronously to the analyzing element in the puncturing direction until they reach the operational position together such that the test field zone of the analyzing element is positioned in front of the measuring and evaluation unit.

23. The method according to claim 22, further comprising,

moving the puncturing element in relation to the analyzing element on the movement path in the puncturing direction in such a position that a tip of the puncturing element projects beyond the analyzing element in the puncturing direction to generate a wound in a body part located in front of the analyzing element in the puncturing direction and to receive a body fluid from the wound through the sample inlet in the capillary channel;

positioning the puncturing element relative to the analyzing element in a transfer position in such a position that the sample outlet of the capillary channel of the puncturing element neighbors the test field zone; and

pressing the puncturing element against the analyzing element by means of a contact pressure unit of the analysis instrument such that the sample outlet of the capillary channel contacts the test field zone and body fluid is transferred from the capillary channel onto the test field zone.

24. The method according to claim 21, further comprising:

moving the integrated sample acquisition and analyzing element opposite to the puncturing direction out of the operational position until the integrated sample acquisition and analyzing element is positioned completely inside the chamber.