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, 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, the sensor body having a blunt tip;
a piercing element comprising a material configured to rapidly dissolve upon insertion into a host, the piercing element abutting the sensor tip and configured for piercing tissue; 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.
2 . The sensor device of claim 1 , wherein the piercing element is secured to the sensor tip.
3 . The sensor device of claim 2 , wherein the piercing element is adhered to the sensor tip.
4 . The sensor device of claim 1 , wherein the piercing element is not secured to the sensor tip, but is maintained in abutting contact therewith.
5 . The sensor device of claim 4 , wherein a sleeve surrounding the sensor tip and the piercing element maintains the abutting contact.
6 . The sensor device of claim 1 , wherein the piercing element comprises a coating that covers at least a portion of the sensor body including the sensor tip.
7 . The sensor device of claim 6 , wherein the coating comprises a sharp coating tip.
8 . The sensor device of claim 1 , wherein the material of the piercing element comprises a material configured to suppress wounding.
9 . The sensor device of claim 1 , wherein the material of the piercing element comprises a material configured to promote rapid wound healing.
10 . The sensor device of claim 1 , wherein the material of the piercing element comprises a material configured to induce osmotic pressure or oncotic pressure.
11 . The sensor device of claim 1 , wherein the material of the piercing element comprises one or more drugs.
12 . The sensor device of claim 1 , wherein the material of the piercing element comprises a vascular endothelial growth factor.
13 . The sensor device of claim 1 , wherein the material of the piercing element comprises at least one material selected from the group consisting of a salt, a metallic salt, a sugar, a synthetic polymer, polylactic acid, polyglycolic acid, and a polyphosphazene.
14 . The sensor device of claim 1 , wherein the material of the piercing element biodegrades or dissolves within a first day after insertion into the host.
15 . The sensor device of claim 14 , wherein the material of the piercing element biodegrades or dissolves within three hours after insertion into the host.
16 . The sensor device of claim 1 , wherein the piercing element does not extend past the sensor tip in the direction of the mounting unit, or extends only a nominal amount in said direction.
17 . The sensor device of claim 1 , wherein the piercing element extends past the sensor tip in the direction of the mounting unit, but stops short of the electrode.
18 . The sensor device of claim 1 , wherein the mounting unit comprises a guiding portion configured to guide insertion of the sensor unit through the host's skin and to support a column strength of the sensor body such that the sensor unit is configured for insertion through the host's skin without substantial buckling.
19 . The sensor device of claim 1 , wherein the at least one electrode comprises a working electrode and a reference electrode.
20 . The sensor device of claim 1 , wherein the sensor body further comprises a support member configured to protect the membrane from damage during insertion of the sensor unit.
21 . The sensor device of claim 20 , wherein the at least one electrode is the support member.
22 . The sensor device of claim 20 , wherein the support member is configured to support at least a portion of the at least one electrode.
23 . The sensor device of claim 20 , wherein the support member is configured to substantially surround the at least one electrode.
24 . The sensor device of claim 1 , wherein the mounting unit comprises a sensor electronics unit operatively and detachably connected to the sensor body.
25 . The sensor device of claim 24 , wherein the sensor electronics unit is configured to be located over a sensor insertion site.