Method and apparatus for measuring an analyte in a body fluid
First Claim
1. An apparatus for lancing the skin of a test subject, collecting a body fluid sample from the lanced site on the skin of the test subject, the apparatus comprising:
- a body having an open end;
a hollow lancet having a tip adapted to puncture skin and to collect a body fluid sample, the interior of the hollow lancet forming a channel for moving a fluid sample from the tip to a reaction area;
a lancing mechanism disposed within the body, the lancing mechanism coupled to the lancet at an end of the lancet opposite the tip, the lancing mechanism being adapted to move the lancet between a retracted position, a lancing position for puncturing the skin of a test subject, and a collection position for collecting the body fluid sample;
an outer end cap having a first end coupled to the open end of the body and a second end for contacting the skin of the test subject, the outer end cap forming a first aperture therein that the tip of the lancet enters when in the lancing position, the outer end cap having a wall extending to the second end thereof; and
an inner end cap disposed within the outer end cap, the inner end cap having a first end coupled to the open end of the body and a second end forming a second aperture therein that the tip of the lancet enters when in the lancing position, the second end being adapted to contact the skin of the test subject when the lancet is in the collecting position, the inner end cap having a wall extending to the second end thereof, the wall of the outer end cap extending farther towards the skin than the wall of the inner end cap during lancing such that the skin of the test subject is drawn inside of the outer end cap and contacts the inner end cap,wherein the second end of the outer end cap and the second end of the inner end cap remain in contact with the skin in the lancing position to assist in sample formation and collection.
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Accused Products
Abstract
An apparatus and method for analyzing an analyte in a body fluid sample using a lancing device (10) having a hollow lancet are disclosed. According to one embodiment of the present invention, the method comprises the acts of lancing the skin of a test subject with the hollow lancet (18) having an interior of the hollow lancet (18) that forms a capillary channel, collecting a body fluid sample from the lanced skin in the capillary channel of the hollow lancet (18), and analyzing the body fluid sample for determining the analyte concentration in the body fluid sample while the collected body fluid sample remains in the lancet (18).
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Citations
33 Claims
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1. An apparatus for lancing the skin of a test subject, collecting a body fluid sample from the lanced site on the skin of the test subject, the apparatus comprising:
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a body having an open end; a hollow lancet having a tip adapted to puncture skin and to collect a body fluid sample, the interior of the hollow lancet forming a channel for moving a fluid sample from the tip to a reaction area; a lancing mechanism disposed within the body, the lancing mechanism coupled to the lancet at an end of the lancet opposite the tip, the lancing mechanism being adapted to move the lancet between a retracted position, a lancing position for puncturing the skin of a test subject, and a collection position for collecting the body fluid sample; an outer end cap having a first end coupled to the open end of the body and a second end for contacting the skin of the test subject, the outer end cap forming a first aperture therein that the tip of the lancet enters when in the lancing position, the outer end cap having a wall extending to the second end thereof; and an inner end cap disposed within the outer end cap, the inner end cap having a first end coupled to the open end of the body and a second end forming a second aperture therein that the tip of the lancet enters when in the lancing position, the second end being adapted to contact the skin of the test subject when the lancet is in the collecting position, the inner end cap having a wall extending to the second end thereof, the wall of the outer end cap extending farther towards the skin than the wall of the inner end cap during lancing such that the skin of the test subject is drawn inside of the outer end cap and contacts the inner end cap, wherein the second end of the outer end cap and the second end of the inner end cap remain in contact with the skin in the lancing position to assist in sample formation and collection. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A method for lancing the skin of a test subject and collecting a produced body fluid sample from the lanced site on the skin of the test subject for determining the concentration of an analyte in the body fluid sample with a lancing and collection device, the lancing and collection device including a substantially optically clear, hollow lancet having a tip for puncturing skin, the method comprising the acts of:
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placing an outer end cap of the device against the skin of a test subject; puncturing the skin with the lancet in a lancing position; positioning the punctured skin against an edge of an inner end cap of the device, the inner end cap being disposed within the outer end cap, the outer end cap extending farther towards the skin than the inner end cap during lancing such that the skin of the test subject is drawn inside the outer end cap and contacts the inner end cap; disposing the tip of the lancet a predetermined distance from the skin pulled against the edge of the inner end cap; and collecting the body fluid sample from the puncture skin with the tip of the lancet in a collecting position; wherein the outer end cap and the inner end cap remain in contact with the skin in the lancing position to assist in sample formation and collection. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33)
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Specification