Analyte Monitoring Device and Methods of Use
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.
1 - 120 . (canceled)
121 . 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 having a length of about 0.3 to about 5 cm within the housing so that a distal end of the electrochemical sensor is inserted to a depth of about 2.0 to about 7 mm beneath the surface of the skin substantially beneath the housing and is bent so that a portion of the sensor is in a plane substantially perpendicular to electrical contacts within the housing, wherein the electrochemical sensor comprises a working electrode comprising an analyte-responsive enzyme and a mediator and wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode;
a RF communication unit for communicating data obtained by the electrochemical sensor; and
a data storage unit for storing analyte data obtained by the electrochemical sensor; and
an adhesive disposed on the bottom surface of the housing to attach the housing to the surface of the skin.
122 . The analyte sensor unit of claim 121 , wherein the electrochemical sensor comprises a proximal end that is in contact with electrical contacts within the housing and a distal end that extends through an opening at the bottom of the housing.
123 . The analyte sensor unit of claim 121 , wherein the distal end of the electrochemical sensor has a length of up to about 6 mm.
124 . The analyte sensor unit of claim 121 , wherein the electrochemical sensor has a length of up to about 2 cm.
125 . The analyte sensor unit of claim 121 , wherein the housing further comprises factory determined calibration information for the electrochemical sensor accessible on a readable or readable/writable memory 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.
126 . The analyte sensor unit of claim 121 , wherein the analyte sensor unit is configured to automatically detect use following insertion by transitioning from a sleep mode to an active mode.
127 . The analyte sensor unit of claim 126 , wherein automatically detecting use comprises detecting a change in resistance in the electrochemical sensor.
128 . The analyte sensor unit of claim 127 , wherein automatically detecting use further comprises activating the analyte sensor unit.
129 . The analyte sensor unit of claim 121 , wherein the RF communication unit receives data from a second RF communication unit of a display unit.
130 . The analyte sensor unit of claim 129 , wherein data received by the RF communication unit comprises an activation signal.
131 . The analyte sensor unit of claim 122 , wherein the electrical contacts are disposed on an interior surface of the housing.
132 . The analyte sensor unit of claim 121 , further comprising a processor to determine the rate of change of the glucose.
133 . The analyte sensor unit of claim 121 , further comprising a processing circuit disposed in the housing for determining a level of an analyte from a signal generated by the electrochemical sensor.
134 . The analyte sensor unit of claim 133 , wherein the processing circuit adjusts the data for temperature using a signal from a temperature probe of the sensor.
135 . The analyte sensor unit of claim 121 , wherein at least one of the analyte-responsive enzyme and the mediator is covalently bonded to the polymer.
136 . The analyte sensor unit of claim 135 , wherein at least one of the analyte-responsive enzyme and the mediator forms one or more of carbon-carbon, carbon-nitrogen, or metal-carbon covalent bonds with the polymer.
137 . The analyte sensor unit of claim 135 , wherein at least one of the analyte-responsive enzyme and the mediator is covalently bonded to the polymer through a linker moiety.
138 . The analyte sensor unit of claim 135 , wherein the mediator is covalently bonded to the polymer through one or more ligands of the mediator.
139 . The analyte sensor unit of claim 138 , wherein the one or more ligands comprises a substituted or unsubstituted heterocyclic nitrogen-containing moiety.
140 . The analyte sensor unit of claim 135 , wherein one or more ligands of the mediator are substituents of the polymer backbone.
141 . The analyte sensor unit of claim 135 , wherein the analyte-responsive enzyme is covalently bonded to the polymer through one or more side chains of the enzyme.
142 . The analyte sensor unit of claim 141 , wherein the one or more side chains of the analyte-responsive enzyme is selected from the group consisting of substituted or unsubstituted amines, alcohols, thiols, phenols, imidazoles, indols, and carboxylic acids.
143 . The analyte sensor unit of claim 135 , wherein one or more side chains of the analyte-responsive enzyme are substituents of the polymer backbone.
144 . The analyte sensor unit of claim 121 , wherein the polymer is crosslinked.
145 . The analyte sensor unit of claim 135 , wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.
146 . The analyte sensor unit of claim 145 , wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer through one or more cros slinking agents.
147 . The analyte sensor unit of claim 146 , wherein the one or more crosslinking agents is selected from the group consisting of substituted or unsubstituted epoxides, aldehydes, imidoesters, N-hydroxysuccinimide esters, carbodiimides, cyanuric chloride, tetrachlorobenzoquinone, benzoquinone and tetracyanoquinodimethane.
148 . The analyte sensor unit of claim 145 , wherein one or more ligands of the mediator are crosslinkers of the polymer.
149 . The analyte sensor unit of claim 145 , wherein one or more side chains of the analyte-responsive enzyme are crosslinkers of the polymer.
150 . The analyte sensor unit of claim 121 , wherein the polymer forms a coordination complex with the mediator.
151 . The analyte sensor unit of claim 150 , wherein one or more nitrogen-containing moieties of the polymer forms a coordination complex with a metal of the mediator.
152 . The analyte sensor unit of claim 121 , wherein the mediator is ionically bonded to the polymer.
153 . The analyte sensor unit of claim 152 , wherein the polymer comprises at least one positively charged moiety and the mediator comprises at least one negatively charged moiety.
154 . The analyte sensor unit of claim 152 , wherein the polymer comprises at least one negatively charged moiety and the mediator comprises at least one positively charged moiety.
155 . The analyte sensor unit of claim 121 , wherein the polymer is chemically bonded to the surface of the working electrode.
156 . The analyte sensor unit of claim 121 , wherein the sensing layer membrane is formed in situ on the working electrode.
157 . The analyte sensor unit of claim 156 , wherein the sensing layer membrane is formed in situ on the working electrode by crosslinking the polymer on the working electrode.
158 . The analyte sensor unit of claim 156 , wherein the working electrode further comprises a mass transport limiting membrane disposed over the sensing layer membrane.
159 . The analyte sensor unit of claim 121 , wherein the analyte-responsive enzyme is a glucose-responsive enzyme.
160 . The analyte sensor unit of claim 121 , wherein the analyte-responsive enzyme is glucose dehydrogenase (GDH) or glucose oxidase (GOx).
161 . The analyte sensor unit of claim 121 , wherein the analyte-responsive enzyme further comprises an enzyme cofactor.
162 . The analyte sensor unit of claim 161 , wherein the enzyme cofactor is flavin adenine dinucleotide.
163 . The analyte sensor unit of claim 121 , wherein the mediator comprises ruthenium or osmium.
164 . 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 having a length of about 0.3 to about 5 cm within the housing so that a distal end of the electrochemical sensor is inserted to a depth of about 2.0 to about 7 mm beneath the surface of the skin substantially beneath the housing and is bent so that a portion of the sensor is in a plane substantially perpendicular to electrical contacts within the housing, wherein the electrochemical sensor comprises a working electrode comprising an analyte-responsive enzyme and a mediator and wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode;
a first RF communication unit for communicating data obtained by the electrochemical sensor;
a data storage unit for storing analyte data obtained by the electrochemical sensor; 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 RF communication unit; and
a display for displaying the concentration of an analyte.
165 . The analyte monitoring system of claim 164 , wherein the electrochemical sensor comprises a proximal end that is in contact with electrical contacts within the housing and a distal end that extends through an opening at the bottom of the housing.
166 . The analyte monitoring system of claim 164 , wherein the distal end of the electrochemical sensor has a length of up to about 6 mm.
167 . The analyte monitoring system of claim 164 , wherein the electrochemical sensor has a length of up to about 2 cm.
168 . The analyte monitoring system of claim 164 , wherein the housing further comprises factory determined calibration information for the electrochemical sensor accessible on a readable or readable/writable memory 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.
169 . The analyte monitoring system of claim 164 , wherein the analyte sensor unit automatically detects use following insertion by transitioning from a sleep mode to an active mode.
170 . The analyte monitoring system of claim 169 , wherein automatically detecting use comprises detecting a change in resistance in the electrochemical sensor.
171 . The analyte monitoring system of claim 169 , wherein automatically detecting use further comprises activating the analyte sensor unit.
172 . The analyte monitoring system of claim 165 , wherein the first RF communication unit receives data from a second RF communication unit of a display unit.
173 . The analyte monitoring system of claim 172 , wherein data received by the RF communication unit comprises an activation signal.
174 . The analyte monitoring system of claim 165 , wherein the electrical contacts are disposed on an interior surface of the housing.
175 . The analyte monitoring system of claim 164 , further comprising a processing circuit disposed in the housing for determining a level of an analyte from a signal generated by the electrochemical sensor.
176 . The analyte monitoring system of claim 164 , wherein at least one of the analyte-responsive enzyme and the mediator is covalently bonded to the polymer.
177 . The analyte monitoring system of claim 176 , wherein at least one of the analyte-responsive enzyme and the mediator is covalently bonded to the polymer through a linker moiety.
178 . The analyte monitoring system of claim 176 , wherein the mediator is covalently bonded to the polymer through one or more ligands of the mediator.
179 . The analyte monitoring system of claim 164 , wherein the polymer is crosslinked.
180 . The analyte monitoring system of claim 179 , wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.
181 . 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 having a length of about 0.3 to about 5 cm within the housing so that a distal end of the electrochemical sensor is inserted to a depth of about 2.0 to about 7 mm beneath the surface of the skin substantially beneath the housing and is bent so that a portion of the sensor is in a plane substantially perpendicular to electrical contacts within the housing, wherein the electrochemical sensor comprises a working electrode comprising an analyte-responsive enzyme and a mediator and wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode;
a first RF communication unit for communicating data obtained by the electrochemical sensor; and
a data storage unit for storing analyte data obtained by the electrochemical sensor; 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;
a display for displaying the concentration of an analyte; and
a test port for receiving an in-vitro analyte sensor.
182 . The analyte monitoring system of claim 181 , wherein the electrochemical sensor comprises a proximal end that is in contact with electrical contacts within the housing and a distal end that extends through an opening at the bottom of the housing.
183 . The analyte monitoring system of claim 181 , wherein the distal end of the electrochemical sensor has a length of up to about 6 mm.
184 . The analyte monitoring system of claim 181 , wherein the electrochemical sensor has a length of up to about 2 cm.
185 . The analyte monitoring system of claim 181 , wherein the housing further comprises factory determined calibration information for the electrochemical sensor accessible on a readable or readable/writable memory 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.
186 . The analyte monitoring system of claim 181 , wherein the analyte sensor unit is automatically detects use following insertion by transitioning from a sleep mode to an active mode.
187 . The analyte monitoring system of claim 186 , wherein automatically detecting use comprises detecting a change in resistance in the electrochemical sensor.
188 . The analyte monitoring system of claim 187 , wherein automatically detecting use further comprises activating the analyte sensor unit.
189 . The analyte monitoring system of claim 181 , wherein the first RF communication unit to receives data from a second RF communication unit of a display unit.
190 . The analyte monitoring system of claim 189 , wherein data received by the first RF communication unit comprises an activation signal.
191 . The analyte monitoring system of claim 182 , wherein the electrical contacts are disposed on an interior surface of the housing.
192 . The analyte monitoring system of claim 181 , further comprising a processing circuit disposed in the housing for determining a level of an analyte from a signal generated by the electrochemical sensor.
193 . The analyte monitoring system of claim 181 , wherein at least one of the analyte-responsive enzyme and the mediator is covalently bonded to the polymer.
194 . The analyte monitoring system of claim 193 , wherein at least one of the analyte-responsive enzyme and the mediator is covalently bonded to the polymer through a linker moiety.
195 . The analyte monitoring system of claim 193 , wherein the mediator is covalently bonded to the polymer through one or more ligands of the mediator.
196 . The analyte monitoring system of claim 181 , wherein the polymer is crosslinked.
197 . The analyte monitoring system of claim 196 , wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.
198 . A method for attaching a sensor control 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 having a length of about 0.3 to about 5 cm within the housing so that a distal end of the electrochemical sensor is inserted to a depth of about 2.0 to about 7 mm beneath the surface of the skin substantially beneath the housing and is bent so that a portion of the sensor is in a plane substantially perpendicular to electrical contacts within the housing, wherein the electrochemical sensor comprises a working electrode comprising an analyte-responsive enzyme and a mediator and wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode;
a first RF communication unit for communicating data obtained by the electrochemical sensor; and
a data storage unit for storing analyte data obtained by the electrochemical sensor; and
an adhesive disposed on the bottom surface of the housing to attach the housing to the surface of the skin; and
applying manual pressure to the analyte sensor unit to attach the analyte sensor unit to the skin using an 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.
199 . The method of claim 198 , wherein the inserter is U-shaped or V-shaped.
200 . The method of claim 198 , wherein the electrochemical sensor comprises a proximal end that is in contact with electrical contacts within the housing and a distal end that extends through an opening at the bottom of the housing.
201 . The method of claim 198 , wherein the distal end of the electrochemical sensor has a length of up to about 6 mm.
202 . The method of claim 198 , wherein the electrochemical sensor has a length of up to about 2 cm.
203 . The method of claim 198 , wherein the housing further comprises factory determined calibration information for the electrochemical sensor accessible on a readable or readable/writable memory 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.
204 . The method of claim 198 , wherein the analyte sensor unit automatically detects use following insertion by transitioning from a sleep mode to an active mode.
205 . The method of claim 204 , wherein automatically detecting use comprises detecting a change in resistance in the electrochemical sensor.
206 . The method of claim 205 , wherein automatically detecting use further comprises activating the analyte sensor unit.
207 . The method of claim 205 , wherein the RF communication unit receives data from a second RF communication unit of a display unit.
208 . The method of claim 207 , wherein data received by the RF communication unit comprises an activation signal.
209 . The method of claim 200 , wherein the electrical contacts are disposed on an interior surface of the housing.
210 . The method of claim 198 , further comprising a processing circuit disposed in the housing for determining a level of an analyte from a signal generated by the electrochemical sensor.
211 . The method of claim 198 , wherein at least one of the analyte-responsive enzyme and the mediator is covalently bonded to the polymer.
212 . The method of claim 211 , wherein at least one of the analyte-responsive enzyme and the mediator is covalently bonded to the polymer through a linker moiety.
213 . The method of claim 211 , wherein the mediator is covalently bonded to the polymer through one or more ligands of the mediator.
214 . The method of claim 198 , wherein the polymer is crosslinked.
215 . 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 having a length of about 0.3 to about 5 cm within the housing so that a distal end of the electrochemical sensor is inserted to a depth of about 2.0 to about 7 mm beneath the surface of the skin substantially beneath the housing and is bent so that a portion of the sensor is in a plane substantially perpendicular to electrical contacts within the housing, wherein the electrochemical sensor comprises a working electrode comprising an analyte-responsive enzyme and a mediator and wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode;
a first RF communication unit for communicating data obtained by the electrochemical sensor; and
a data storage unit for storing analyte data obtained by the electrochemical sensor; and
an adhesive disposed on the bottom surface of the housing to attach the housing to the surface of the skin; and
applying manual pressure to the analyte sensor unit to attach the analyte sensor unit to the skin using an 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 using a cocked spring of the insertion device;
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.
216 . The method of claim 215 , wherein the inserter is U-shaped or V-shaped.
217 . The method of claim 215 , wherein the electrochemical sensor comprises a proximal end that is in contact with electrical contacts within the housing and a distal end that extends through an opening at the bottom of the housing.
218 . The method of claim 215 , wherein the distal end of the electrochemical sensor has a length of up to about 6 mm.
219 . The method of claim 215 , wherein the electrochemical sensor has a length of up to about 2 cm.
220 . The method of claim 215 , wherein the housing further comprises factory determined calibration information for the electrochemical sensor accessible on a readable or readable/writable memory 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.
221 . The method of claim 215 , wherein the analyte sensor unit automatically detects use following insertion by transitioning from a sleep mode to an active mode.
222 . The method of claim 221 , wherein automatically detecting use comprises detecting a change in resistance in the electrochemical sensor.
223 . The method of claim 222 , wherein automatically detecting use further comprises activating the analyte sensor unit.
224 . The method of claim 215 , wherein the RF communication unit receives data from a second RF communication unit of a display unit.
225 . The method of claim 224 , wherein data received by the RF communication unit comprises an activation signal.
226 . The metho of claim 217 , wherein the electrical contacts are disposed on an interior surface of the housing.
227 . The method of claim 215 , further comprising a processing circuit disposed in the housing for determining a level of an analyte from a signal generated by the electrochemical sensor.
228 . The method of claim 215 , wherein at least one of the analyte-responsive enzyme and the mediator is covalently bonded to the polymer.
229 . The method of claim 228 , wherein at least one of the analyte-responsive enzyme and the mediator is covalently bonded to the polymer through a linker moiety.
230 . The method of claim 229 , wherein the mediator is covalently bonded to the polymer through one or more ligands of the mediator.
231 . The method of claim 215 , wherein the polymer is crosslinked.