Analysis system and method for determining an analyte in a body fluid with a magazine comprising integrated sample acquisition and analyzing elements

• US 8,888,715 B2
• Filed: 02/25/2010
• Issued: 11/18/2014
• Est. Priority Date: 08/31/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: List, Hans, Frey, Stephan-Michael, Fluegge, Kai
• Primary Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US12/712,236
• Publication Number:
  US 20110060246A1
• Time in Patent Office: 1,727 Days
• Field of Search: 600/573, 600/583, 600/584, 606181-183
• 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 chambers have two major sides delimited by the side walls and two long minor 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 comprising;

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 contact pressure unit located in front of the magazine in the puncture direction that is configured to apply force to a major surface of the puncturing element to bring the puncturing element into contact with the analyzing element;

a magazine holder for holding the magazine; and

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 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 magazine is advanced using the contact pressure unit.

4. 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.

5. 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.

6. The analysis system according to claim 5, 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.

7. 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.

8. 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.

9. 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 chambers have two major sides delimited by the side walls and two long minor 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 comprising;

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 chambers 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; and

wherein the analyzing element includes a test field zone and in an initial configuration of the integrated sample acquisition and analyzing element, the test field zone is positioned forward of a tip of the puncturing element in the puncturing direction and 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 the test field zone of the analyzing element without contacting the test field zone.

10. 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 chambers have two major sides delimited by the side walls and two long minor 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 comprising;

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 chambers 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; and

wherein the puncturing element is enclosed by a protective envelope, the protective envelope is connected to the puncturing element at a first location on the protective envelope and is connected to the analyzing element at a second location on the protective envelope and is telescoped upon a relative movement of the puncturing element relative to the analyzing element in the puncturing direction whereby the distance in the puncture direction between the first and second locations on the protective envelope is reduced, and wherein a tip of the puncturing element penetrates the protective envelope and extends out of the protective envelope.

11. An analysis system for determining an analyte in a body fluid, the system comprising a magazine and an analysis instrument;

the magazine comprising;

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 has two flat sides; and

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 minor 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 the 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;

the analysis instrument comprising;

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; and

a magazine holder for holding the magazine.

12. An analysis system for determining an analyte in a body fluid, the system comprising a magazine and an analysis instrument;

the magazine comprising;

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 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;

the analysis instrument comprising;

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; and

a magazine holder for holding the magazine.

13. The analysis system according to claim 12, 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 minor 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.

14. The analysis system according to claim 13, 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.

15. The analysis system according to claim 12, 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.

16. The analysis system according to claim 12, wherein the film for covering the minor sides of the plurality of neighboring chambers is at least partially metallic.

17. The analysis system according to claim 12, 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.

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

an analysis instrument; and

a magazine comprising a plurality of integrated sample acquisition and analyzing elements, each element 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 at a first location on the protective envelope and is connected to the analyzing element at a second location on the protective envelope and is telescoped upon a relative movement of the puncturing element in relation to the analyzing element in the puncturing direction whereby the distance in the puncture direction between the first and second locations on the protective envelope is reduced, and wherein the tip of the puncturing element penetrates the protective envelope and extending out of the protective envelope;

the magazine having 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 chambers have two major sides delimited by the side walls and two long minor sides and two short minor sides extending between the side walls, wherein each chamber contains one of the plurality of integrated sample acquisition and analyzing elements; and

the analysis instrument comprising;

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 contact pressure unit located in front of the magazine in the puncture direction that is configured to apply force to a major surface of the puncturing element to bring the puncturing element into contact with the analyzing element;

a magazine holder for holding the magazine; and

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 can be formfitting coupled to the coupling structure of the puncturing element, when the puncturing element is position in the chamber and the magazine is located in the holder.

19. The analysis system according to claim 18, 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.

20. Analysis system for determining an analyte in a body fluid, the system comprising:

a reusable analysis instrument; and

a magazine including a plurality of flat, disposable, integrated sample acquisition and analyzing elements, each comprising a puncturing element and an analyzing element and having two major surfaces;

the analysis instrument comprising;

a drive, by which a puncture movement of the puncturing element is driven, for movement on a movement path, the puncture movement including a propulsion phase in the puncturing direction and, after reaching a reversal point, a retraction phase opposite to the puncturing direction;

a coupling unit, adapted for coupling an integrated sample acquisition and analyzing element to the drive;

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

a magazine holder for holding the magazine;

the magazine comprising;

a plurality of elongate chambers located neighboring one another, the chambers being separated by side walls running in the longitudinal direction of the chambers, and having a height and length greater than its width, which is defined by the distance of two neighboring side walls; and

wherein the chambers have two major sides delimited by the side walls and two long and two short minor sides extending between the side walls;

the chambers contain an integrated sample acquisition and analyzing element, whose puncturing element has a coupling structure and is movable on the movement path of the puncture movement in the puncturing direction, and whose analyzing element has a second coupling structure;

the chambers have an exit opening on one of their minor sides for allowing at least partial exiting out of the chamber of a puncturing element moved on the movement path;

the coupling unit has a coupling element and another coupling element;

the chambers of the magazine are accessible for the coupling element on one of their long minor sides such that the coupling element can be coupled to the coupling structure of the puncturing element and that the another coupling element can be coupled to the coupling structure of the analyzing element when the puncturing element and the analyzing element are positioned in the chamber of the magazine and the magazine is located in the holder.