Analysis system for determining an analyte in a body fluid and disposable integrated sample acquisition and analysis element
First Claim
1. An analysis system for determining an analyte in a body fluid, comprising:
- a disposable integrated sample acquisition and analysis element comprising,a flat test strip having a front end and a sample receiving zone to receive a body fluid sample for analysis, wherein the sample receiving zone is located on a flat side of the test strip to form a sample contact side, wherein the sample receiving zone is adjacent to the front end of the test strip in a puncture direction, anda piercing element located parallel to the test strip and adjacent to the sample contact side of the test strip, the piercing element comprising,a tip for generating a bodily puncture wound, anda capillary channel comprising,a sample inlet for body fluid entry after the piercing into the capillary channel, anda sample outlet for body fluid exit from the capillary channel,wherein the piercing element is movable relative to the test strip on a movement path during at least a part of a puncture movement and is positioned in the puncture direction behind the sample receiving zone in such a manner that the sample receiving zone is located between the piercing element and the front end of the test strip,a reusable analysis instrument comprising,a coupling unit adapted to couple the integrated sample acquisition and analysis element to a drive for driving the piercing element in a piercing movement, wherein the piercing movement comprising,a propulsion phase in which the piercing element is moved on a puncture path in the puncture direction,a retraction phase in which the piercing element is moved opposite to the puncture direction after reaching a reversal point of the piercing movement, anda sample transfer position, wherein the sample outlet is adjacent to the sample receiving zone of the test strip such that body fluid may be transferred from the capillary channel through the sample outlet to the sample receiving zone, anda measuring and analysis unit for measuring a measurement variable characteristic for the determination of the analyte and for determining a desired analysis result on the basis of the measurement.
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Accused Products
Abstract
An analyte determination analysis system with a disposable integrated sample acquisition and analysis element is disclosed. A piercing element has a tip for generating a bodily puncture wound and a test strip having a body fluid sample receiving zone to perform an analysis on a body fluid sample. A reusable analysis instrument comprises a coupling unit that couples the integrated sample acquisition and analysis element to a drive that drives a piercing element in a piercing movement comprising two phases: a propulsion phase wherein the piercing element moves on a puncture path in a puncture direction and a retraction phase wherein the piercing element moves opposite to the puncture direction after reaching a reversal point. A measuring and analysis unit measures a variable characteristic for the determination of the analyte and determines a desired analysis result on the basis of the measurement. The sample receiving zone of the test strip forms a sample contact. The piercing element, located parallel to the test strip, moves on a movement path relative to the test strip a puncture path. The piercing element, located adjacent to the sample contact, has a capillary channel with a sample inlet for body fluid entry after the piercing and a sample outlet for body fluid exit. The piercing element movement has a sample transfer position wherein the sample outlet is adjacent to the sample receiving zone such that the body fluid may be transferred from the capillary channel through the sample outlet to the sample receiving zone.
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Citations
17 Claims
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1. An analysis system for determining an analyte in a body fluid, comprising:
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a disposable integrated sample acquisition and analysis element comprising, a flat test strip having a front end and a sample receiving zone to receive a body fluid sample for analysis, wherein the sample receiving zone is located on a flat side of the test strip to form a sample contact side, wherein the sample receiving zone is adjacent to the front end of the test strip in a puncture direction, and a piercing element located parallel to the test strip and adjacent to the sample contact side of the test strip, the piercing element comprising, a tip for generating a bodily puncture wound, and a capillary channel comprising, a sample inlet for body fluid entry after the piercing into the capillary channel, and a sample outlet for body fluid exit from the capillary channel, wherein the piercing element is movable relative to the test strip on a movement path during at least a part of a puncture movement and is positioned in the puncture direction behind the sample receiving zone in such a manner that the sample receiving zone is located between the piercing element and the front end of the test strip, a reusable analysis instrument comprising, a coupling unit adapted to couple the integrated sample acquisition and analysis element to a drive for driving the piercing element in a piercing movement, wherein the piercing movement comprising, a propulsion phase in which the piercing element is moved on a puncture path in the puncture direction, a retraction phase in which the piercing element is moved opposite to the puncture direction after reaching a reversal point of the piercing movement, and a sample transfer position, wherein the sample outlet is adjacent to the sample receiving zone of the test strip such that body fluid may be transferred from the capillary channel through the sample outlet to the sample receiving zone, and a measuring and analysis unit for measuring a measurement variable characteristic for the determination of the analyte and for determining a desired analysis result on the basis of the measurement. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A disposable integrated sample acquisition and analysis element of an analysis system comprising:
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a flat test strip having a front end and a sample receiving zone to receive a body fluid sample for analysis, wherein the sample receiving zone is located on a flat side of the test strip to form a sample contact side, wherein the sample receiving zone is adjacent to the front end of the test strip in a puncture direction, and a piercing element located parallel to the test strip and adjacent to the sample contact side of the test strip, the piercing element comprising, a tip for generating a bodily puncture wound, and a capillary channel comprising, a sample inlet for body fluid entry after the piercing into the capillary channel, and a sample outlet for body fluid exit from the capillary channel, wherein the piercing element is movable relative to the test strip on a movement path during at least a part of a puncture movement and is positioned in the puncture direction behind the sample receiving zone in such a manner that the sample receiving zone is located between the piercing element and the front end of the test strip. - View Dependent Claims (13, 14, 15, 16, 17)
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Specification