Integrated lancing and measurement device and analyte measuring methods
First Claim
1. A device for determining the concentration of an analyte in a biological fluid from a patient, comprising:
- a piercing member sufficient to cause the fluid to flow from a site on the patient;
a sensor sufficient to generate an electrical signal indicative of the concentration of the analyte in the fluid, the sensor comprising;
a working electrode;
a sensing layer;
a counter electrode; and
a measurement zone sized to contain a volume of less than about 1 μ
l; and
an analyzer operatively connected to the sensor, andwherein the piercing member and the sensor are mechanically attached together to form an integrated unit that is disconnectable from said analyzer as said integrated unit.
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Accused Products
Abstract
An integrated lancing and measurement device is provided comprising a sensor designed to determine the amount and/or concentration of analyte in a biological fluid having a volume of less than about 1 μL. A piercing member is adapted to pierce and retract from a site on the patient to cause the fluid to flow therefrom, and the sensor is positioned adjacent to the site on the patient so as to receive the fluid flowing from the site to generate an electrical signal indicative of the concentration of the analyte in the fluid. The sensor is comprised of a working electrode comprising an analyte-responsive enzyme and a redox mediator, and a counter electrode. An analyte monitor is operatively connected to the sensor and adapted to measure the signal generated by the sensor. Also provided are analyte measuring methods that optionally employ the integrated lancing and measurement device.
841 Citations
65 Claims
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1. A device for determining the concentration of an analyte in a biological fluid from a patient, comprising:
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a piercing member sufficient to cause the fluid to flow from a site on the patient; a sensor sufficient to generate an electrical signal indicative of the concentration of the analyte in the fluid, the sensor comprising;
a working electrode;
a sensing layer;
a counter electrode; and
a measurement zone sized to contain a volume of less than about 1 μ
l; andan analyzer operatively connected to the sensor, and wherein the piercing member and the sensor are mechanically attached together to form an integrated unit that is disconnectable from said analyzer as said integrated unit. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29)
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30. The device for determining a concentration of an analyte in a fluid from a site on a subject, comprising:
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a piercing member sufficient to pierce the site such that the fluid flows therefrom; and a sensor sufficient to generate a signal indicative of the concentration of the analyte in the fluid, the sensor comprising;
a working electrode;
a sensing layer;
a counter electrode; and
a measurement zone size to contain a volume of less than about 1 μ
l;wherein the sensor is adapted so that a signal generated by the sensor in connection with electrolysis of a buffer solution with 10 mM glucose is greater than a signal generated by the sensor in connection with electrolysis of a buffer solution with no glucose, and wherein the piercing member and the sensor are mechanically attached together to form an integrated unit that is disconnectable from said analyzer as said integrated unit. - View Dependent Claims (31, 32, 33, 34, 35, 36, 37, 38, 39)
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40. A method for determining the concentration of an analyte in a fluid from a site on a subject, the method comprising:
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providing a piercing member, a sensor for generating a signal, and an analyzer for measuring the signal, wherein the sensor comprises;
a working electrode;
a sensing layer;
a counter electrode; and
a measurement zone, and wherein the piercing member and the sensor are mechanically attached together to form an integrated unit that is disconnectable from said analyzer as said integrated unit;piercing the site via the piercing member such that fluid flows from the site to the measurement zone; generating a signal indicative of the concentration of the analyte in the fluid using less than about 1 μ
l of the fluid in the measurement zone via the sensor,measuring the signal via the analyzer; and disconnecting said integrated unit from said analyzer. - View Dependent Claims (41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65)
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Specification