Analyte Sensor
An analyte sensor configured to be implanted in the body of the user unassisted by an introducer sharp.
1 . An analyte sensor configured to detect an analyte of interest in a biological fluid, the analyte sensor comprising:
a sensor body including a proximal portion and a distal end, wherein the distal end includes a downward taper to define a substantially pointed tip, and further wherein the substantially pointed tip is configured to pierce through a skin layer to at least partially insert the sensor under the skin of a user;
one or more electrodes disposed on at least one surface of the sensor body; and
a polymer coating disposed over at least a portion of the distal end of the sensor body.
2 . The analyte sensor of claim 1 , wherein at least a portion of the sensor body includes a flexible material.
3 . The analyte sensor of claim 1 , wherein the portion of the distal end of the sensor with the polymer coating disposed thereon includes at least the tip of the distal end.
4 . The analyte sensor of claim 3 , wherein the polymer coating applied to the tip provides sufficient rigidity to the tip to pierce the skin of a user.
5 . The analyte sensor of claim 4 , wherein at least the distal tip of the sensor is configured to pierce through the skin layer without the use of a separate introducer sharp.
6 . The analyte sensor of claim 1 , wherein the sensor body includes two opposing lateral sides, and wherein the polymer coating is applied to at least one of the opposing lateral sides.
7 . The analyte sensor of claim 6 , wherein the polymer coating is applied to both of the opposing lateral sides.
8 . The analyte sensor of claim 1 , wherein a plurality of polymer coatings is applied to the sensor body.
9 . The analyte sensor of claim 8 , wherein the plurality of polymer coatings include polymer coatings having different durometers.
10 . The analyte sensor of claim 8 , wherein the plurality of polymer coatings applied to the sensor substrate define a sensor having varied flexibility along a length thereof.
11 . The analyte sensor of claim 8 , wherein the plurality of polymer coatings include one polymer coating applied in a plurality of layers along a surface of the sensor body.
12 . The analyte sensor of claim 11 , wherein the plurality of layers define a varied thickness along a surface of the sensor body.
13 . The analyte sensor of claim 1 , wherein the polymer coating includes a biocompatible, bio-absorbable or bioresorbable polymer.
14 . The analyte sensor of claim 13 , wherein the polymer coating includes a lactic acid polymer coating.
15 . The analyte sensor of claim 14 , wherein the polymer coating includes polylactic acid.
16 . The analyte sensor of claim 13 , wherein the polymer coating dissolves in the body of the user during implantation of the sensor.
17 . The analyte sensor of claim 1 , wherein the polymer coating includes a polyamide, polycarbonate, polyurethane, crosslinked polymer, or block copolymer.
18 . The analyte sensor of claim 1 , wherein the polymer coating is applied to the sensor body by one or more techniques including spin coating, drip coating, dip coating, spray coating, direct coating or immersion.
19 . The analyte sensor of claim 1 , wherein at least a portion of one or more of the electrodes disposed on the sensor body include a sensing layer disposed thereon.
20 . The analyte sensor of claim 19 , wherein the polymer coating is not applied to the portion of the one or more electrodes including the sensing layer.
21 . An analyte sensor configured to detect an analyte of interest in a biological fluid, the analyte sensor comprising:
an injection molded sensor body including a proximal portion and a distal end;
one or more electrodes disposed on the distal end of the sensor body, the one or more electrodes including at least one working electrode; and
a polymer coating disposed over at least a portion of the distal end of the sensor body;
wherein the distal end includes a downward taper to define a substantially pointed tip, wherein the tip is configured to pierce through a skin layer of a user to at least partially insert the sensor through the skin layer without the requirement of an introducer sharp.
22 . The analyte sensor of claim 21 , wherein the sensor includes one or more protrusions extending from one or more surfaces of the sensor body.
23 . The analyte sensor of claim 22 , wherein the one or more protrusions are configured to engage a carrier of an inserter device.
24 . The analyte sensor of claim 23 , wherein the carrier has a body including at least one flange along a surface, wherein the one or more protrusions are configured to engage the at least one flange of the carrier.
25 . The analyte sensor of claim 23 , wherein the carrier includes a stopper configured to abut the proximal portion of the sensor body during engagement.
26 . The analyte sensor of claim 21 , wherein the sensor is a unitary structure.
27 . The analyte sensor of claim 21 , wherein the sensor body is formed by a micro-molding technique.
28 . The analyte sensor of claim 21 , wherein at least the tip includes a lubricious coating.
29 . The analyte sensor of claim 21 , wherein the one or more electrodes comprise gold.
30 . The analyte sensor of claim 28 , wherein the gold electrodes are formed by laser ablation.
31 . The analyte sensor of claim 21 , wherein the polymer coating includes a biocompatible, bio-absorbable or bioresorbable polymer.
32 . The analyte sensor of claim 30 , wherein the polymer coating dissolves in the body of the user during implantation of the sensor.