SENSORS FOR CONTINUOUS ANALYTE MONITORING, AND RELATED METHODS
Sensor devices including dissolvable tissue-piercing tips are provided. The sensor devices can be used in conjunction with dissolvable needles configured for inserting the sensor devices into a host. Hardening agents for strengthening membranes on sensor devices are also provided. Methods of using and fabricating sensor devices are also provided.
1 . A sensor device for measuring an analyte concentration in a host, the sensor device being configured for implantation in the host without use of an inserter, comprising:
a sensor unit comprising a sensor body, at least one electrode, and a membrane covering at least a portion of the at least one electrode;
a piercing element at a distal end of the sensor unit, the piercing element being configured for piercing skin and/or tissue of the host;
a mounting unit spaced from the sensor tip and configured to support the sensor device on an exterior surface of the host's skin; and
a retractable introducer sheath configured to cover at least a portion of the membrane during insertion of the sensor device.
2 . The sensor device of claim 1 , wherein a proximal end of the tissue piercing element has a diameter greater than a diameter of the sensor body.
3 . The sensor device of claim 2 , wherein a diameter of the introducer sheath is substantially equal to or less than the diameter of the proximal end of the tissue piercing element.
4 . A sensor device for measuring an analyte concentration in a host, the sensor device being configured for implantation in the host without use of an inserter, comprising:
a sensor unit comprising a sensor body, at least one electrode, and a membrane covering at least a portion of the at least one electrode; and
a piercing element at a distal end of the sensor unit, the piercing element being configured for piercing skin and/or tissue of the host;
a mounting unit spaced from the sensor tip and configured to support the sensor device on an exterior surface of the host's skin;
wherein the sensor body includes a cross-section that defines at least one trough that extends along a length of the sensor body.
5 . The sensor device of claim 4 , wherein the cross-section of the sensor body defines a plus sign with four evenly spaced troughs.
6 . The sensor device of claim 4 , wherein the cross-section of the sensor body defines a circle with a single trough.
7 . The sensor device of claim 4 , wherein the at least one electrode is located in the at least one trough.
8 . The sensor device of claim 7 , wherein the at least one electrode and the at least one membrane are flush with or recessed beneath an outer perimeter of the sensor body.
9 . A sensor device for measuring an analyte concentration in a host, the sensor device being configured for implantation in the host without use of an inserter, comprising:
a sensor unit comprising a sensor body, at least one electrode, and a membrane covering at least a portion of the at least one electrode;
a piercing element at a distal end of the sensor unit, the piercing element being configured for piercing skin and/or tissue of the host; and
a mounting unit spaced from the sensor tip and configured to support the sensor device on an exterior surface of the host's skin;
wherein the sensor body includes a plurality of depressions.
10 . The sensor device of claim 9 , wherein the membrane is disposed within at least one of the depressions.
11 . The sensor device of claim 10 , wherein the membrane is flush with an outer surface of the sensor body, or recessed beneath the outer surface of the sensor body.
12 . The sensor device of claim 9 , wherein the depressions are randomly arranged.
13 . A sensor device for measuring an analyte concentration in a host, the sensor device being configured for implantation in the host without use of an inserter, comprising:
a sensor unit comprising a sensor body, at least one electrode, and a membrane covering at least a portion of the at least one electrode;
a piercing element at a distal end of the sensor unit, the piercing element being configured for piercing skin and/or tissue of the host;
a mounting unit spaced from the sensor tip and configured to support the sensor device on an exterior surface of the host's skin; and
a plurality of axially spaced depressions in the sensor body.
14 . The sensor device of claim 13 , wherein the membrane is disposed within the depressions.
15 . The sensor device of claim 14 , further comprising an outer layer of a material that is permeable to one or more selected analytes.