Analyte monitoring device and methods of use
First Claim
1. An analyte sensor unit comprising:
- a housing adapted for placement on the surface of skin having a bottom surface for contacting with the skin and wherein the housing comprises;
an electrochemical sensor comprising a plurality of electrodes including a working electrode, wherein the sensor comprises a portion within the housing and a portion exterior to the housing to permit insertion of the electrochemical sensor to a depth of about 2 to about 7 mm beneath the surface of the skin, wherein the electrochemical sensor comprises a substrate comprising all of the plurality of electrodes;
sensor electronics comprising an RF communication unit for communicating data obtained by the electrochemical sensor, the sensor electronics coupled to the electrochemical sensor through the electrical contacts, wherein the sensor electronics comprise electrical contacts that are positioned between at least a portion of the electrochemical sensor and the bottom surface of the housing; and
a readable or readable/writable memory for storing factory determined calibration information for calibrating the electrochemical sensor, wherein the electrochemical sensor does not require user-implemented calibration following insertion of a portion of the sensor beneath the surface of the skin; and
an adhesive disposed on the bottom surface of the housing to attach the housing to the surface of the skin.
3 Assignments
0 Petitions
Accused Products
Abstract
An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte. The analyte monitor may also be part of a drug delivery system to alter the level of the analyte based on the data obtained using the sensor.
-
Citations
115 Claims
-
1. An analyte sensor unit comprising:
-
a housing adapted for placement on the surface of skin having a bottom surface for contacting with the skin and wherein the housing comprises; an electrochemical sensor comprising a plurality of electrodes including a working electrode, wherein the sensor comprises a portion within the housing and a portion exterior to the housing to permit insertion of the electrochemical sensor to a depth of about 2 to about 7 mm beneath the surface of the skin, wherein the electrochemical sensor comprises a substrate comprising all of the plurality of electrodes; sensor electronics comprising an RF communication unit for communicating data obtained by the electrochemical sensor, the sensor electronics coupled to the electrochemical sensor through the electrical contacts, wherein the sensor electronics comprise electrical contacts that are positioned between at least a portion of the electrochemical sensor and the bottom surface of the housing; and a readable or readable/writable memory for storing factory determined calibration information for calibrating the electrochemical sensor, wherein the electrochemical sensor does not require user-implemented calibration following insertion of a portion of the sensor beneath the surface of the skin; and an adhesive disposed on the bottom surface of the housing to attach the housing to the surface of the skin. - 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, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 109, 110, 111, 112)
-
-
43. An analyte monitoring system for determining the concentration of an analyte comprising:
-
an analyte sensor unit comprising; a housing adapted for placement on the surface of skin having a bottom surface for contacting with the skin and wherein the housing comprises; an electrochemical sensor comprising a plurality of electrodes including a working electrode, wherein the sensor comprises a portion within the housing and a portion exterior to the housing to permit insertion of the electrochemical sensor to a depth of about 2 to about 7 mm beneath the surface of the skin, wherein the electrochemical sensor comprises a substrate comprising all of the plurality of electrodes; sensor electronics comprising an RF communication unit for communicating data obtained by the electrochemical sensor, the sensor electronics coupled to the electrochemical sensor through the electrical contacts, wherein the sensor electronics comprise electrical contacts that are positioned between at least a portion of the electrochemical sensor and the bottom surface of the housing; and a readable or readable/writable memory for storing factory determined calibration information for calibrating the electrochemical sensor, wherein the electrochemical sensor does not require user-implemented calibration following insertion of a portion of the sensor beneath the surface of the skin; and an adhesive disposed on the bottom surface of the housing to attach the housing to the surface of the skin; and a display unit comprising a housing, wherein the housing comprises; a second RF communication unit for communicating with the first wireless communication unit; and a display to display the concentration of an analyte. - View Dependent Claims (44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 113)
-
-
59. An analyte monitoring system for determining the concentration of an analyte comprising:
-
an analyte sensor unit comprising; a housing adapted for placement on the surface of skin having a bottom surface for contacting with the skin and wherein the housing comprises; an electrochemical sensor comprising a plurality of electrodes including a working electrode, wherein the sensor comprises a portion within the housing and a portion exterior to the housing to permit insertion of the electrochemical sensor to a depth of about 2 to about 7 mm beneath the surface of the skin, wherein the electrochemical sensor comprises a substrate comprising all of the plurality of electrodes; sensor electronics comprising an RF communication unit for communicating data obtained by the electrochemical sensor, the sensor electronics coupled to the electrochemical sensor through the electrical contacts, wherein the sensor electronics comprise electrical contacts that are positioned between at least a portion of the electrochemical sensor and the bottom surface of the housing; and a readable or readable/writable memory for storing factory determined calibration information for calibrating the electrochemical sensor, wherein the electrochemical sensor does not require user-implemented calibration following insertion of a portion of the sensor beneath the surface of the skin; and an adhesive disposed on the bottom surface of the housing to attach the housing to the surface of the skin; and a display unit comprising a housing, wherein the housing comprises; a second RF communication unit to communicate with the first wireless communication unit; a display for displaying the concentration of an analyte; and a test port to receive an in-vitro analyte sensor. - View Dependent Claims (60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 114)
-
-
75. A method for attaching an analyte sensor unit to the skin of a patient, the method comprising:
-
contacting an insertion device coupled with an analyte sensor unit to the skin of a patient;
the analyte sensor unit comprising;a housing adapted for placement on the surface of skin having a bottom surface for contacting with the skin and wherein the housing comprises; an electrochemical sensor comprising a plurality of electrodes including a working electrode, wherein the sensor comprises a portion within the housing and a portion exterior to the housing to permit insertion of the electrochemical sensor to a depth of about 2 to about 7 mm beneath the surface of the skin, wherein the electrochemical sensor comprises a substrate comprising all of the plurality of electrodes; sensor electronics comprising an RF communication unit for communicating data obtained by the electrochemical sensor, the sensor electronics coupled to the electrochemical sensor through the electrical contacts, wherein the sensor electronics comprise electrical contacts that are positioned between at least a portion of the electrochemical sensor and the bottom surface of the housing; and a readable or readable/writable memory for storing factory determined calibration information for calibrating the electrochemical sensor, wherein the electrochemical sensor does not require user-implemented calibration following insertion of a portion of the sensor beneath the surface of the skin; and an adhesive disposed on the bottom surface of the housing to attach the housing to the surface of the skin; applying manual pressure to the insertion device coupled with the analyte sensor unit to attach the analyte sensor unit to the skin using the adhesive; inserting at least a portion of the electrochemical sensor to a depth of about 2.0 to about 7 mm beneath the surface of the skin; and decoupling the insertion device from the sensor control unit. - View Dependent Claims (76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 115)
-
-
92. A method for monitoring the concentration of an analyte, the method comprising:
-
contacting an insertion device coupled with an analyte sensor unit to the skin of a patient;
the analyte sensor unit comprising;a housing adapted for placement on the surface of skin having a bottom surface for contacting with the skin and wherein the housing comprises; an electrochemical sensor comprising a plurality of electrodes including a working electrode, wherein the sensor comprises a portion within the housing and a portion exterior to the housing to permit insertion of the electrochemical sensor to a depth of about 2 to about 7 mm beneath the surface of the skin, wherein the electrochemical sensor comprises a substrate comprising all of the plurality of electrodes; sensor electronics comprising an RF communication unit for communicating data obtained by the electrochemical sensor, the sensor electronics coupled to the electrochemical sensor through the electrical contacts, wherein the sensor electronics comprise electrical contacts that are positioned between at least a portion of the electrochemical sensor and the bottom surface of the housing; and a readable or readable/writable memory for storing factory determined calibration information for calibrating the electrochemical sensor, wherein the electrochemical sensor does not require user-implemented calibration following insertion of a portion of the sensor beneath the surface of the skin; and an adhesive disposed on the bottom surface of the housing to attach the housing to the surface of the skin; applying manual pressure to the insertion device coupled with the analyte sensor unit to attach the analyte sensor unit to the skin using the adhesive; inserting at least a portion of the electrochemical sensor to a depth of about 2 to about 7 mm beneath the surface of the skin; decoupling the insertion device from the sensor control unit; collecting data from the electrochemical sensor corresponding to the analyte; communicating the data to a display unit comprising a second RF communication unit and a display unit; and displaying a concentration of the analyte on the display unit. - View Dependent Claims (93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108)
-
Specification