# US 8,275,439 B2 · Analyte monitoring device and methods of use > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,275,439 B2 - Document ID: US8275439B2 - Status: Granted - Kind: B2 - Application number: 12/614,974 - Filed: 2009-11-09 - Published: 2010-03-04 - Granted: 2012-09-25 - Earliest claimed: 1998-04-30 - Assignees: Abbott Diabetes Care Inc. - Inventors: James Say; Michael F. Tomasco; Adam Heller; Yoram Gal; Behrad Aria; Ephraim Heller; Phillip John Plante; Mark S. Vreeke; Keith A. Friedman; Fredric C. Colman - Web page: https://patentgrep.com/patent/US8275439B2 ## CPC - A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement} - A61B 5/01: Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20) - A61B 5/14503: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors (A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence)} - A61B 5/1451: {for interstitial fluid} - A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes} - A61B 5/1486: using enzyme electrodes, e.g. with immobilised oxidase - A61B 5/14865: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors} - A61B 5/1495: Calibrating or testing of in-vivo probes - A61B 5/4839: {combined with drug delivery} - A61B 5/72: {Signal processing specially adapted for physiological signals or for diagnostic purposes} - A61B 5/7278: {Artificial waveform generation or derivation, e.g. synthesizing signals from measured signals} - A61B 5/7282: {Event detection, e.g. detecting unique waveforms indicative of a medical condition (cough events A61B5/0823; seizures A61B5/4094; sleep apnoea A61B5/4818)} - A61B 5/7405: {using sound} - A61B 5/743: {Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots} - A61B 5/7445: {Display arrangements, e.g. multiple display units} - A61B 5/7455: {characterised by tactile indication, e.g. vibration or electrical stimulation} - A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure} - C12Q 1/54: involving glucose or galactose - G16H 10/40: for data related to laboratory analysis, e.g. patient specimen analysis - G16H 20/17: delivered via infusion or injection - H10W 70/424: {Cross-sectional shapes (H10W70/481 takes precedence)} - H10W 74/111: {the semiconductor body being completely enclosed} - A61B 5/0002: {Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network (endoradiosondes A61B5/07)} - A61B 5/002: {Monitoring the patient using a local or closed circuit, e.g. in a room or building (A61B5/0017 takes precedence)} - A61B 5/1473: invasive, e.g. introduced into the body by a catheter - A61B 2560/0252: using ambient temperature - Y10S 128/903: Radio telemetry - Y10T 29/49: Method of mechanical manufacture - Y10T 29/49124: On flat or curved insulated base, e.g., printed circuit, etc. - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA - H10W: GENERIC PACKAGES, INTERCONNECTIONS, CONNECTORS OR OTHER CONSTRUCTIONAL DETAILS OF DEVICES COVERED BY CLASS H10 - Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS - Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION ## Abstract 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. ## Claims ### Claim 1 A sensor control unit comprising: an electrochemical sensor configured for partial implantation through the skin of a subject, comprising: a substrate having a narrow distal region for partial implantation through a skin surface and a wider proximal region, the substrate including at least a first surface and a second surface; at least one working electrode disposed on the narrow distal region of the substrate and in fluid contact with interstitial fluid under the skin surface, the at least one working electrode formed on the first surface of the substrate; at least one reference electrode disposed on the narrow distal region of the substrate, the at least one reference electrode formed on the first surface of the substrate; at least one counter electrode disposed on the narrow distal region of the substrate, the at least one counter electrode formed on the second surface of the substrate; a plurality of first conductive contacts disposed on the wider proximal region of the substrate and on the first surface of the substrate, wherein a first one of the plurality of first conductive contacts is in electrical communication with the working electrode, a second one of the plurality of first conductive contacts is in electrical communication with the reference electrode, and a third one of the plurality of first conductive contacts is in electrical communication with the counter electrode; and at least one via formed through the substrate that electrically connects the counter electrode to the third one of the plurality of first conductive contacts; a housing adapted for placement on the skin of the subject and comprising a second conductive contact adapted to couple to the wider proximal portion of the sensor without intervening wires between the first conductive contact and the second conductive contact; and an rf transmitter disposed in the housing for transmitting data obtained from the sensor. ### Claim 2 (depends on 1) The sensor control unit of claim 1, further comprising adhesive for adhering the sensor control unit to skin. ### Claim 3 (depends on 1) The sensor control unit of claim 1, wherein the housing is adapted for placement substantially over an insertion site of the sensor. ### Claim 4 (depends on 1) The sensor control unit of claim 1, wherein the first conductive contact and the second conductive contact are adapted to couple by physical proximity. ### Claim 5 (depends on 1) The sensor control unit of claim 1, wherein the second conductive contact is provided on an exterior portion of the housing. ### Claim 6 (depends on 1) The sensor control unit of claim 1, wherein the second conductive contact is provided on an interior portion of the housing. ### Claim 7 (depends on 1) The sensor control unit of claim 1, wherein the sensor is flexible. ### Claim 8 (depends on 1) The sensor control unit of claim 1, wherein the sensor comprises a body. ### Claim 9 (depends on 8) The sensor control unit of claim 8, wherein the body includes the substrate. ### Claim 10 (depends on 9) The sensor control unit of claim 9, wherein the substrate is fabricated from a polymeric or plastic material. ### Claim 11 (depends on 9) The sensor control unit of claim 9, wherein the substrate is fabricated from polyimide. ### Claim 12 (depends on 9) The sensor control unit of claim 9, wherein the first conductive contact is disposed on the substrate. ### Claim 13 (depends on 8) The sensor control unit of claim 8, wherein the working electrode is fabricated from a wire. ### Claim 14 (depends on 1) The sensor control unit of claim 1, wherein the first conductive contact comprises at least one contact pad. ### Claim 15 (depends on 1) The sensor control unit of claim 1, further comprising a data storage unit disposed in the housing for holding data relating to sensor measurements. ### Claim 16 (depends on 15) The sensor control unit of claim 15, wherein the data storage unit holds data relating to sensor measurements permanently. ### Claim 17 (depends on 15) The sensor control unit of claim 15, wherein the data storage unit holds data relating to sensor measurements temporarily. ### Claim 18 (depends on 15) The sensor control unit of claim 15, wherein the data storage unit comprises a readable/writeable memory storage device. ### Claim 19 A sensor control unit comprising: an electrochemical sensor configured for at least partial implantation through the skin of a subject, comprising: a substrate having a narrow distal region for partial implantation through a skin surface and a wider proximal region, the substrate including at least a first surface and a second surface; at least one working electrode disposed on the narrow distal region of the substrate and in fluid contact with interstitial fluid under the skin surface, the at least one working electrode formed on the first surface of the substrate; at least one reference electrode disposed on the narrow distal region of the substrate, the at least one reference electrode formed on the first surface of the substrate; at least one counter electrode disposed on the narrow distal region of the substrate, the at least one counter electrode formed on the second surface of the substrate; a plurality of first conductive contacts disposed on the wider proximal region of the substrate and on the first surface of the substrate, wherein a first one of the plurality of first conductive contacts is in electrical communication with the working electrode, a second one of the plurality of first conductive contacts is in electrical communication with the reference electrode, and a third one of the plurality of first conductive contacts is in electrical communication with the counter electrode; and at least one via formed through the substrate that electrically connects the counter electrode to the third one of the plurality of first conductive contacts; a housing adapted for placement on the skin of the subject and comprising a second conductive contact, wherein the housing is adapted to couple the second conductive contact to the first conductive contact, the housing further comprising a support which holds a portion of the sensor in a fixed position relative to the housing; and an rf transmitter disposed in the housing for transmitting data obtained from the sensor. ### Claim 20 (depends on 19) The sensor control unit of claim 19, wherein the support is configured to align the first conductive contact with the second conductive contact. ### Claim 21 (depends on 19) The sensor control unit of claim 19, further comprising an opening in the housing for guiding insertion of the electrochemical sensor into the skin. ### Claim 22 (depends on 19) The sensor control unit of claim 19, wherein the opening in the housing overlies an insertion site of the sensor when the housing is placed on the skin. ### Claim 23 (depends on 19) The sensor control unit of claim 19, wherein the support holds the sensor in a bent position with respect to the housing. ### Claim 24 (depends on 19) The sensor control unit of claim 19, further comprising a support disposed on the housing for aligning the first conductive contact with the second conductive contact. ### Claim 25 (depends on 19) The sensor control unit of claim 19, wherein the portion of the electrochemical sensor is maintained by the housing in a fixed position by a structure which obstructs the sliding of the sensor with respect to the housing.