ANALYSIS SYSTEM AND METHOD FOR DETERMINING AN ANALYTE IN A BODY FLUID
First Claim
1. An analysis system for determining an analyte in a body fluid sample acquired through a prick in the skin, including:
- a magazine having a plurality of chambers, containinga plurality of analysis elements, each analysis element having a sample contact zone and a reagent system containing at least one reagent, whose reaction with the sample results in a measurable change of a measuring variable, anda plurality of puncturing elements, each puncturing element having a tip for piercing into the skin, the tip having a capillary channel which forms a fluid connection between the tip and a sample transfer zone of the puncturing element,a reusable analysis instrument havinga puncturing drive for driving a puncture movement of a puncturing element on a movement path, which comprises a propulsion phase in the puncturing direction and, after reaching a reversal point of the puncture movement, a retraction phase opposite to the puncturing direction,a mounting for receiving the magazine in such a manner that one chamber of the magazine at a time is located in a functional position, in which a puncturing element in the chamber can be moved by the puncturing drive, anda measuring and evaluation apparatus for measuring the measurable change of the measuring variable and for determining a desired analysis result,whereinthe magazine further includes two partial magazines, includinga puncturing element partial magazine having puncturing element chambers, which each contain one puncturing element, andan analysis element partial magazine having analysis element chambers, which each contain one analysis element, andwhereinin the functional position of the magazine, both partial magazines can be brought into a relative position, in which a puncturing element exit opening of a puncturing element chamber and a puncturing element entry opening of an analysis element chamber are adjacent to one another aligned in such a manner that a puncturing element can be moved from the puncturing element chamber through its puncturing element exit opening and through the puncturing element entry opening of the adjacent analysis element chamber into the analysis element chamber, andthe puncturing element entry opening of the analysis element chamber is sealed by means of a sealing film which is opened before or during the puncture movement of the puncturing element from the puncturing element chamber into the analysis element chamber.
3 Assignments
0 Petitions
Accused Products
Abstract
A system for determining an analyte in a body fluid includes a magazine comprising two partial magazines, one including chambers containing analysis elements having a sample contact zone and a reagent system containing a reagent, whose reaction with the body fluid results in a change of a variable, and another including chambers containing puncturing elements having a tip having a capillary channel, which forms a fluid connection between the tip and a sample transfer zone of the puncturing element. The system may also include an analysis instrument having a puncturing drive for driving a puncturing element on a movement path, a mounting for receiving the magazine such that one chamber of the magazine at a time is located in a functional position, in which a puncturing element in the chamber can be moved by the puncturing drive, and a measuring and evaluation apparatus for measuring the change of the variable.
20 Citations
36 Claims
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1. An analysis system for determining an analyte in a body fluid sample acquired through a prick in the skin, including:
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a magazine having a plurality of chambers, containing a plurality of analysis elements, each analysis element having a sample contact zone and a reagent system containing at least one reagent, whose reaction with the sample results in a measurable change of a measuring variable, and a plurality of puncturing elements, each puncturing element having a tip for piercing into the skin, the tip having a capillary channel which forms a fluid connection between the tip and a sample transfer zone of the puncturing element, a reusable analysis instrument having a puncturing drive for driving a puncture movement of a puncturing element on a movement path, which comprises a propulsion phase in the puncturing direction and, after reaching a reversal point of the puncture movement, a retraction phase opposite to the puncturing direction, a mounting for receiving the magazine in such a manner that one chamber of the magazine at a time is located in a functional position, in which a puncturing element in the chamber can be moved by the puncturing drive, and a measuring and evaluation apparatus for measuring the measurable change of the measuring variable and for determining a desired analysis result, wherein the magazine further includes two partial magazines, including a puncturing element partial magazine having puncturing element chambers, which each contain one puncturing element, and an analysis element partial magazine having analysis element chambers, which each contain one analysis element, and wherein in the functional position of the magazine, both partial magazines can be brought into a relative position, in which a puncturing element exit opening of a puncturing element chamber and a puncturing element entry opening of an analysis element chamber are adjacent to one another aligned in such a manner that a puncturing element can be moved from the puncturing element chamber through its puncturing element exit opening and through the puncturing element entry opening of the adjacent analysis element chamber into the analysis element chamber, and the puncturing element entry opening of the analysis element chamber is sealed by means of a sealing film which is opened before or during the puncture movement of the puncturing element from the puncturing element chamber into the analysis element chamber. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. A magazine for an analysis instrument, including:
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a plurality of chambers, including a plurality of analysis elements, each analysis element having a sample contact zone and a reagent system containing at least one reagent, whose reaction with a body fluid results in a measurable change of a measuring variable, and a plurality of puncturing elements, each puncturing element having a tip for piercing into the skin having a capillary channel which forms a fluid connection between the tip and a sample transfer zone of the puncturing element, wherein the magazine is configured to be received in a mounting of an analysis instrument such that one puncturing element at a time in one of the chambers of the magazine can be moved by a puncturing drive of the analysis instrument on a movement path, which comprises a propulsion phase in the puncturing direction, in order to execute a puncture movement, and wherein the magazine further includes two partial magazines, including a puncturing element partial magazine having a plurality of puncturing element chambers, which each contain one puncturing element, and an analysis element partial magazine having a plurality of analysis element chambers, which each contain one analysis element, wherein both partial magazines being movable relative to one another so that a puncturing element exit opening of a puncturing element chamber and a puncturing element entry opening of an analysis element chamber are adjacent and aligned, the analysis element partial magazine further including a transparent area, the analysis element being positioned in the analysis element partial magazine relative to the transparent area in such a manner that a change of a measuring variable in the analysis element can be measured by means of a photoelectric measuring unit, which is positioned outside the magazine. - View Dependent Claims (23, 24)
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25. A method for producing a two-part magazine from two separate partial magazines including a puncturing element partial magazine having a plurality of puncturing element chambers, each containing one puncturing element, and an analysis element partial magazine having a plurality of analysis element chambers, each containing one analysis element, including the steps of:
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a) equipping the puncturing element partial magazine with puncturing elements; b) sealing a puncturing element exit opening of each puncturing element chamber with a film; c) sealing a connection element entry opening of each puncturing element chamber with a film; d) sterilizing the puncturing elements in the puncturing element partial magazine; e) connecting the two partial magazines; f) sealing a puncturing element entry opening of each analysis element chamber of the analysis element partial magazine with a film; g) equipping the analysis element partial magazine with analysis elements; and h) sealing a magazine outlet opening of each analysis element chamber of the analysis element partial magazine with a film. - View Dependent Claims (26, 27)
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28. A magazine for an analysis instrument, including:
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a plurality of chambers, including a plurality of analysis elements, each analysis element having a sample contact zone and a reagent system containing at least one reagent, whose reaction with a body fluid sample results in a measurable change of a measuring variable, and a plurality of puncturing elements, each puncturing element having a tip for piercing into the skin, the tip having a capillary channel, which forms a fluid connection between the tip and a sample transfer zone of the puncturing element, wherein the magazine is implemented for being received in a mounting of an analysis instrument in such a manner that one puncturing element at a time in one of the chambers of the magazine can be moved by a puncturing drive of the analysis instrument on a movement path, which comprises a propulsion phase in the puncturing direction, in order to execute a puncture movement, the magazine further including two partial magazines, including a puncturing element partial magazine having a plurality of puncturing element chambers, which each contain one puncturing element, and an analysis element partial magazine having a plurality of analysis element chambers, which each contain one analysis element, wherein both partial magazines being movable relative to one another so that a puncturing element exit opening of a puncturing element chamber and a puncturing element entry opening of an analysis element chamber are adjacent to one another aligned in such a manner that one puncturing element can be moved from the puncturing element chamber through its puncturing element exit opening and through the puncturing element entry opening of the adjacent analysis element chamber into the analysis element chamber, and the puncturing element entry opening of the analysis element chamber is sealed by means of a sealing film, which is positioned and implemented to be opened before or during the puncture movement of the puncturing element from the puncturing element chamber into the analysis element chamber. - View Dependent Claims (29, 30, 31, 32, 33, 34, 35, 36)
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Specification