Biosensor and methods for manufacturing
First Claim
1. A biosensor adapted to detect an analyte in a body fluid sample, comprising:
- a single-piece, electrically-insulating, elongated body having a uniform, alignment-selective, cross-sectional shape throughout its length, and having a first orthogonal end surface at a first end of the body and a second orthogonal end surface at the second end of the body, the alignment-selective, cross-sectional shape constituting a body registration feature for orienting said body in a predetermined position relative to a receptacle in which said body is placed;
at least two electrical conductors embedded and electrically insulated completely along their length within the single-piece body and extending between the first and second end surfaces of the body, the at least two electrical conductors having exposed first end surfaces flush and coplanar with the first end surface of the body and exposed second end surfaces flush and coplanar with the second end surface of the body; and
a reagent disposed on the exposed first end surfaces of the at least two electrical conductors, the reagent being configured to electrochemically react with a body fluid sample applied to the reagent, and wherein the reagent is in electrical communication with the electrical conductors when the body fluid is applied to the reagent.
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Accused Products
Abstract
A biosensor for detecting an analyte in a sample of body fluid and methods for manufacturing the biosensor are disclosed. In one embodiment, a biosensor includes at least two electrical conductors embedded within an electrically insulating test element body. The electrical conductors are exposed at two ends of the test element body and a reagent, for example a reagent adapted to test for blood glucose, is applied to one end. In one form, the test element body is cylindrical with a circular or non-circular cross-sectional shape. In other embodiments, the test elements are manufactured by a resin pultrusion process in which resin embedded with electrical conductors is dried or cured, shaped and cut into segments, and reagent applied to one end of each segment.
44 Citations
27 Claims
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1. A biosensor adapted to detect an analyte in a body fluid sample, comprising:
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a single-piece, electrically-insulating, elongated body having a uniform, alignment-selective, cross-sectional shape throughout its length, and having a first orthogonal end surface at a first end of the body and a second orthogonal end surface at the second end of the body, the alignment-selective, cross-sectional shape constituting a body registration feature for orienting said body in a predetermined position relative to a receptacle in which said body is placed; at least two electrical conductors embedded and electrically insulated completely along their length within the single-piece body and extending between the first and second end surfaces of the body, the at least two electrical conductors having exposed first end surfaces flush and coplanar with the first end surface of the body and exposed second end surfaces flush and coplanar with the second end surface of the body; and a reagent disposed on the exposed first end surfaces of the at least two electrical conductors, the reagent being configured to electrochemically react with a body fluid sample applied to the reagent, and wherein the reagent is in electrical communication with the electrical conductors when the body fluid is applied to the reagent. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A system for detecting an analyte in a sample of body fluid, comprising:
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a biosensor comprising a single-piece, electrically-insulating, elongated body having a uniform, alignment-selective, cross-sectional shape throughout its length, and having a first orthogonal end surface at a first end of the body and a second orthogonal end surface at the second end of the body, the alignment-selective, cross-sectional shape constituting a body registration feature for orienting said body in a predetermined position relative to a receptacle in which said body is received, at least two electrical conductors embedded and electrically insulated completely along their length within the body and extending between the first and second end surfaces of the body, the at least two electrical conductors having exposed first end surfaces flush and coplanar with the first end surface of the body and exposed second end surfaces flush and coplanar with the second end surface of the body, a reagent being disposed on the exposed first end surfaces of the at least two electrical conductors; and a test meter comprising a receptacle configured to receive the bio sensor, the receptacle defining an opening shaped complementary with the cross-sectional shape of the body, the body being received within the opening of the receptacle and thereby being oriented in a predetermined position relative to the receptacle, the receptacle further including at least two electrical connectors adapted to electrically connect with the second end surfaces of the electrical conductors when the second end of the body is inserted into the receptacle. - View Dependent Claims (9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
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25. A bio sensor adapted to detect an analyte in a body fluid sample, consisting of:
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a single-piece, electrically-insulating, elongated body having a uniform, alignment-selective, cross-sectional shape throughout its length, and having a first orthogonal end surface at a first end of the body and a second orthogonal end surface at the second end of the body, the alignment-selective, cross-sectional shape constituting a body registration feature for orienting said body in a predetermined position relative to a receptacle in which said body is placed; at least two electrical conductors embedded and electrically insulated completely along their length within the single-piece body and extending between the first and second end surfaces of the body, the at least two electrical conductors having exposed first end surfaces flush and coplanar with the first end surface of the body and exposed second end surfaces flush and coplanar with the second end surface of the body; and a reagent disposed on the exposed first end surfaces of the at least two electrical conductors, the reagent being configured to electrochemically react with a body fluid sample applied to the reagent, and wherein the reagent is in electrical communication with the electrical conductors when the body fluid is applied to the reagent. - View Dependent Claims (26, 27)
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Specification