Analyte monitoring device and methods of use

A method of detecting a level of an analyte in a bodily fluid, comprising:

• inserting a portion of a sensor transcutaneously, the sensor comprising a substrate, a transmitter and a working electrode, the substrate having the transmitter and the working electrode disposed upon it, the working electrode being configured and arranged to produce a signal representative of a level of an analyte in a bodily fluid;
• holding a portion of the sensor in a fixed orientation relative to skin through which the portion of the sensor is trancutaneously inserted;
• and
• transmitting a signal representing the level of the analyte to a receiver.

A method of manufacturing a population of analyte monitoring devices, each analyte monitoring device comprising an electrochemical sensor and a transmitter, the method comprising:

• assigning a first set of spreading codes to a first transmitter within a first subset of the population of analyte monitoring devices;
• assigning a second set of spreading codes to a second transmitter within a second subset of the population of analyte monitoring devices, wherein the second set of spreading codes excludes the first set of spreading codes;
• and
• coupling the first transmitter to the electrochemical sensor, so as to provide the first transmitter with a conductive path to receive from the electrochemical sensor a signal representative of an analyte level in a bodily fluid.

An analyte monitoring device comprising:

• an electrochemical sensor, at least a portion of which is adapted for implantation and intimate contact with bodily fluid, the electrochemical sensor producing a signal representative of a level of an analyte in the bodily fluid;
• and
• a transmitter coupled to the electrochemical sensor, the transmitter being configured and arranged to:
• convert the signal representative of the level of the analyte in the bodily fluid into a digital signal representing the level of the analyte in the bodily fluid;
• assemble a plurality of data words into a data message, at least one of the data words containing data derived from the digital signal representing the level of the analyte in the bodily fluid, each of the data words comprising a set of bits, wherein for at least two of the data words, the set of bits are organized into a set of data bits and a set of error correction bits;
• and
• transmit the data message, such that the bits comprising one of the plurality of data words assembled into the data message are not transmitted contiguously.

An analyte monitoring device comprising:

• an electrochemical sensor, at least a portion of which is adapted for transcutaneous implantation and intimate contact with bodily fluid, the electrochemical sensor producing a signal representative of a level of an analyte in the bodily fluid
• a non-implanted temperature sensor oriented, adapted, and arranged to produce a signal representative of skin surface temperature;
• and
• a transmitter coupled to the temperature sensor and to the electrochemical sensor, the transmitter being configured and arranged to transmit a data message derived at least in part from the signal representative of the level of the analyte in the bodily fluid.

An insertion kit for inserting a portion of an electrochemical sensor into a patient, the insertion kit comprising:

• an insertion device comprising a portion having a sharp, rigid structure adapted to support the sensor during insertion of the electrochemical sensor into a site of implantation and to facilitate insertion of a portion of the electrochemical sensor into the patient;
• an insertion gun having a port configured to pass the electrochemical sensor and the insertion device, a driving mechanism for driving the insertion device and electrochemical sensor into the patient, and a retraction mechanism for removing the insertion device from the patient while leaving the sensor within the patient;
• an electrochemical sensor, a portion of which is configured and arranged to be inserted into the patient using the insertion device and insertion gun;
• and
• a mounting unit.

A method of disposing an electrochemical sensor into a patient transcutaneously, comprising:

• unpackaging an insertion kit, wherein the insertion kit comprises:
• an insertion device comprising a portion having a sharp, rigid structure adapted to support the sensor during insertion of the electrochemical sensor into a site of implantation and to facilitate insertion of a portion of the electrochemical sensor into the patient;
• an insertion gun having a port configured to pass the electrochemical sensor and the insertion device, a driving mechanism for driving the insertion device and electrochemical sensor into the patient, and a retraction mechanism for removing the insertion device from the patient while leaving the sensor within the patient;
• an electrochemical sensor, a portion of which is configured and arranged to be inserted into the patient using the insertion device and insertion gun;
• and
• a mounting unit, with at least a portion of at least one surface having an adhesive disposed thereon, the adhesive being protected by a removable shield;
• wherein, the insertion device is mated with the sensor, the mated insertion device and sensor are loaded in the insertion gun, and the mounting unit is mated with insertion gun;
• removing the shield from the mounting unit, thereby exposing the adhesive disposed upon the portion of the at least one surface of the mounting unit;
• applying the mouniting unit to a skin surface, such that the adhesive comes in contact with the skin surface;
• activating the driving mechanism, thereby driving the insertion device and electrochemical sensor into the patient;
• withdrawing the insertion gun, such that the mounting base is left adhered to the skin surface and the electrochemical sensor is left driven into the patient.