US20080119703A1 - Analyte sensor - Google Patents

Analyte sensor Download PDF

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Publication number
US20080119703A1
US20080119703A1 US11/543,396 US54339606A US2008119703A1 US 20080119703 A1 US20080119703 A1 US 20080119703A1 US 54339606 A US54339606 A US 54339606A US 2008119703 A1 US2008119703 A1 US 2008119703A1
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US
United States
Prior art keywords
sensor
analyte
analyte sensor
host
catheter
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US11/543,396
Other languages
English (en)
Inventor
Mark Brister
Sean Saint
Vance Swanson
James R. Petisce
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Dexcom Inc
Original Assignee
Dexcom Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Dexcom Inc filed Critical Dexcom Inc
Priority to US11/543,396 priority Critical patent/US20080119703A1/en
Priority to US11/543,404 priority patent/US8532730B2/en
Priority to US11/543,490 priority patent/US8774886B2/en
Priority to US11/691,466 priority patent/US7615007B2/en
Priority to US11/691,432 priority patent/US7775975B2/en
Priority to US11/691,426 priority patent/US20080108942A1/en
Priority to US11/691,424 priority patent/US8911367B2/en
Priority to CNA2007800446434A priority patent/CN101547633A/zh
Priority to EP14177544.5A priority patent/EP2796090A1/de
Priority to AU2007305002A priority patent/AU2007305002B2/en
Priority to EP07843011.3A priority patent/EP2091409B1/de
Priority to CA002664426A priority patent/CA2664426A1/en
Priority to JP2009531522A priority patent/JP2010505534A/ja
Priority to PCT/US2007/079220 priority patent/WO2008042625A2/en
Priority to US12/055,149 priority patent/US20080200788A1/en
Priority to US12/055,227 priority patent/US8364230B2/en
Priority to US12/055,114 priority patent/US8364231B2/en
Priority to US12/055,203 priority patent/US8425416B2/en
Priority to US12/055,078 priority patent/US20080197024A1/en
Publication of US20080119703A1 publication Critical patent/US20080119703A1/en
Priority to US12/267,494 priority patent/US8425417B2/en
Priority to US12/267,531 priority patent/US8447376B2/en
Priority to US12/267,544 priority patent/US8478377B2/en
Priority to US12/267,545 priority patent/US8275438B2/en
Priority to US12/267,518 priority patent/US8287453B2/en
Priority to US12/267,548 priority patent/US8562528B2/en
Priority to US12/267,525 priority patent/US8626257B2/en
Priority to US12/267,547 priority patent/US8298142B2/en
Priority to US12/267,542 priority patent/US8886273B2/en
Priority to US12/267,546 priority patent/US8449464B2/en
Assigned to DEXCOM, INC. reassignment DEXCOM, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SWANSON, VANCE, SAINT, SEAN, PETISCE, JAMES R., BRISTER, MARK
Priority to US12/535,620 priority patent/US20090287074A1/en
Priority to US12/630,628 priority patent/US20100081910A1/en
Priority to US12/713,607 priority patent/US20100298684A1/en
Priority to US13/720,227 priority patent/US9451908B2/en
Priority to US13/743,452 priority patent/US9037210B2/en
Priority to US14/059,237 priority patent/US20140088391A1/en
Priority to US14/072,659 priority patent/US10052055B2/en
Priority to US14/256,716 priority patent/US20140213869A1/en
Priority to US15/140,307 priority patent/US10349873B2/en
Priority to US16/036,808 priority patent/US20180325437A1/en
Priority to US16/431,607 priority patent/US20190282143A1/en
Priority to US16/526,910 priority patent/US20190357827A1/en
Priority to US16/599,535 priority patent/US11382539B2/en
Priority to US17/316,228 priority patent/US20210259587A1/en
Priority to US18/087,171 priority patent/US20230414140A1/en
Priority to US18/232,794 priority patent/US20230380729A1/en
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
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    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14546—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1473—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
    • A61B5/14865—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1495—Calibrating or testing of in-vivo probes
    • A—HUMAN NECESSITIES
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B5/41—Detecting, measuring or recording for evaluating the immune or lymphatic systems
    • A61B5/412—Detecting or monitoring sepsis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848—Needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848—Needles
    • A61B5/6849—Needles in combination with a needle set
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0223—Operational features of calibration, e.g. protocols for calibrating sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14542—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring blood gases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A61M2230/201—Glucose concentration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16804—Flow controllers

Definitions

  • the preferred embodiments relate generally to systems and methods for measuring an analyte in a host.
  • Diabetes mellitus is a disorder in which the pancreas cannot create sufficient insulin (Type I or insulin dependent) and/or in which insulin is not effective (Type 2 or non-insulin dependent).
  • Type I or insulin dependent in which the pancreas cannot create sufficient insulin
  • Type 2 or non-insulin dependent in which insulin is not effective
  • a hypoglycemic reaction low blood sugar
  • SMBG self-monitoring blood glucose
  • a variety of sensors are known that use an electrochemical cell to provide output signals by which the presence or absence of an analyte, such as glucose, in a sample can be determined.
  • an analyte or a species derived from it that is electro-active generates a detectable signal at an electrode, and this signal can be used to detect or measure the presence and/or amount within a biological sample.
  • an enzyme is provided that reacts with the analyte to be measured, and the byproduct of the reaction is qualified or quantified at the electrode.
  • An enzyme has the advantage that it can be very specific to an analyte and also, when the analyte itself is not sufficiently electro-active, can be used to interact with the analyte to generate another species which is electro-active and to which the sensor can produce a desired output.
  • immobilized glucose oxidase catalyses the oxidation of glucose to form hydrogen peroxide, which is then quantified by amperometric measurement (for example, change in electrical current) through a polarized electrode.
  • a system for measuring an analyte comprising a vascular access device in communication with a vascular system of a host; and an analyte sensor configured to extend within the vascular access device, wherein the analyte sensor is configured to measure a concentration of an analyte within the vascular system.
  • the analyte sensor is configured to extend through the vascular access device and into a blood stream of the host.
  • the vascular access device is a catheter.
  • the vascular access device is configured for insertion into a vein of the host.
  • the vascular access device is configured for insertion into an artery of the host.
  • the vascular access device is configured to operatively couple to a pressure transducer for measurement of a blood pressure of the host.
  • the vascular access device is configured to operatively couple to a blood chemistry analysis device for measuring a blood chemistry of the host.
  • the analyte sensor is a glucose sensor.
  • the system further comprises a sheath configured to protect the analyte sensor during insertion of the analyte sensor into the catheter.
  • the sheath can comprise a slot configured to allow the release of the analyte sensor therefrom.
  • the system further comprises a fluid coupler having first end and second end, wherein the fluid coupler is configured to mate with the vascular access device on the first end, and wherein at least a portion of the analyte sensor extends through the fluid coupler or is housed within the fluid coupler.
  • the fluid coupler can comprise sensor electronics formed thereon.
  • the sensor electronics can a potentiostat.
  • the fluid coupler can be configured to mate with a medical device on the second end.
  • the medical device can comprise at least one device selected from the group consisting of a blood pressure monitor, a blood chemistry device, and a dialysis bypass machine.
  • the analyte sensor is configured to extend through the vascular access device and into a blood stream of the host by from about 0.010 inches to about 1 inch.
  • the vascular access device and the analyte sensor are configured to indwell within a blood stream of the host in vivo.
  • the analyte sensor comprises at least one working electrode configured to measure a first signal.
  • the first signal can be substantially analyte related.
  • the analyte sensor further comprises a second working electrode configured to measure a second signal.
  • the second signal can be substantially non-analyte related.
  • the sensor electronics are configured to process the second signal and the first signal to determine a concentration of an analyte.
  • the senor further comprises a reference electrode.
  • the reference electrode is located at a position remote from the working electrode.
  • the senor further comprises a fluid coupler having first end and a second end, wherein the fluid coupler is configured to mate with the catheter on the first end, wherein at least a portion of the analyte sensor extends through the fluid coupler or is housed within the fluid coupler, and wherein the reference electrode is located at a position proximal to the fluid coupler or within the fluid coupler.
  • an end of the analyte sensor that extends into a blood stream of the host comprises an enlarged area.
  • a substantial portion of the analyte sensor has a diameter of less than about 0.008 inches.
  • a substantial portion of the analyte sensor has a diameter of less than about 0.004 inches.
  • the analyte sensor further comprises a bioinert material or a bioactive agent incorporated therein or thereon.
  • the bioactive agent can comprise at least one agent selected from the group consisting of vitamin K antagonists, heparin group anticoagulants, platelet aggregation inhibitors, enzymes, direct thrombin inhibitors, Dabigatran, Defibrotide, Dermatan sulfate, Fondaparinux, and Rivaroxaban.
  • the analyte sensor comprises a working electrode and a reference electrode, wherein at least one of the working electrode and the reference electrode comprises a wire.
  • the analyte sensor comprises a working electrode and a reference electrode, wherein the working electrode and the reference electrode are both wires, and wherein the wires are coaxial.
  • the analyte sensor comprises a working electrode and a reference electrode, wherein the working electrode and the reference electrode are both wires, and wherein the wires are juxtapositioned.
  • the analyte sensor comprises a working electrode and a reference electrode, wherein the working electrode and the reference electrode are both wires, and wherein the reference electrode is helically wound around the working electrode.
  • the analyte sensor comprises a working electrode, and wherein the working electrode is flexible.
  • the analyte sensor comprises a working electrode, and wherein the working electrode has a variable stiffness.
  • the analyte sensor comprises at least one wire having a helical configuration, wherein a variable stiffness in the helical wire is provided by at least one of a variable pitch of the helical wire and a variable cross-section of the helical wire.
  • a method for measuring an analyte in a blood stream of a host comprising inserting a vascular access device into communication with a blood stream of a host; and inserting an analyte sensor into the vascular access device, wherein the analyte sensor measures a concentration of an analyte within the blood stream of the host.
  • the analyte sensor extends through the vascular access device and into the blood stream.
  • the vascular access device is a catheter.
  • the vascular access device is inserted into a vein of the host.
  • the vascular access device is inserted into an artery of the host.
  • the method further comprises coupling a pressure transducer to the analyte sensor.
  • the method further comprises coupling a blood chemistry analysis device to the analyte sensor.
  • the analyte sensor measures glucose
  • the analyte sensor comprises a fluid coupler for housing the analyte sensor or supporting the analyte sensor, and wherein the method further comprises mating the fluid coupler with the vascular access device on a first end of the fluid coupler.
  • the method further comprises mating the fluid coupler with a medical device on a second end of the fluid coupler.
  • the method further comprises measuring at least one other parameter with the medical device, wherein the parameter is selected from the group consisting of blood pressure and blood chemistry.
  • the step of inserting the analyte sensor comprises inserting the analyte sensor beyond an in vivo end of the vascular access device by from about 0.010 inches to about 1 inch.
  • the vascular access device and the analyte sensor are configured to indwell within a blood stream of the host in vivo.
  • sensor electronics are operatively connected to the analyte sensor, and wherein the method further comprises utilizing sensor electronics to measure a concentration of an analyte within the host.
  • the analyte sensor comprises at least one working electrode, and wherein the method further comprises measuring a first signal at the working electrode, and wherein the first signal is substantially analyte-related.
  • the analyte sensor further comprises a second working electrode, and wherein the method further comprises measuring a second signal at the second working electrode.
  • the second signal can be substantially non-analyte-related.
  • the method further comprises processing the second signal and the first signal to determine a concentration of an analyte.
  • the method further comprises avoiding piercing of a blood vessel during sensor insertion into the blood vessel by providing an enlarged area at an insertion end of the analyte sensor.
  • the method further comprises substantially preventing clotting or thrombosis proximal to or on the analyte sensor within the blood stream.
  • a system for measuring an analyte comprising a vascular access device configured for insertion communication with a vascular system of a host, wherein the vascular access device comprises an analyte sensor at least partially integrally incorporated therewith; and sensor electronics operatively connected to the analyte sensor, wherein the sensor electronics are configured to measure a concentration of an analyte within the vascular system.
  • the sensor electronics are configured to substantially continuously measure the analyte concentration.
  • the analyte is glucose
  • the vascular access device is configured to operatively couple to a blood chemistry analysis device for measuring a blood chemistry of the host.
  • the analyte sensor comprises at least one working electrode configured measure a first signal.
  • the first signal is substantially analyte related.
  • the analyte sensor further comprises a second working electrode configured measure a second signal.
  • the second signal is substantially non-analyte related.
  • the sensor electronics are configured to process the second signal and the first signal to determine a concentration of an analyte.
  • the analyte sensor further comprises a reference electrode.
  • the reference electrode is located at a position remote from the reference electrode.
  • the reference electrode is configured to be located outside of a blood stream of the host.
  • the analyte sensor further comprises a counter electrode.
  • the analyte sensor is configured to at least partially contact an in vivo blood stream of the host when the vascular access device is inserted therein.
  • the analyte sensor is deposited on an exterior surface of the vascular access device.
  • the analyte sensor is electroplated onto the exterior surface of the vascular access device.
  • the analyte sensor is wired to at least a portion of the sensor electronics.
  • the analyte sensor is wirelessly connected to at least a portion of the sensor electronics.
  • the vascular access device is a catheter.
  • the analyte sensor further comprises a bioinert material or a bioactive agent incorporated therewith.
  • the bioactive agent can comprise at least one agent selected from the group consisting of vitamin K antagonists, heparin group anticoagulants, platelet aggregation inhibitors, enzymes, direct thrombin inhibitors, Dabigatran, Defibrotide, Dermatan sulfate, Fondaparinux, and Rivaroxaban.
  • the analyte sensor comprises a working electrode and a reference electrode, and wherein at least one of the working electrode and the reference electrode comprises a wire.
  • the analyte sensor comprises a working electrode and a reference electrode, wherein the working electrode and the reference electrode are both wires, and wherein the wires are coaxial.
  • the analyte sensor comprises a working electrode and a reference electrode, wherein the working electrode and the reference electrode are both wires, and wherein the wires are juxtapositioned.
  • the analyte sensor comprises a working electrode and a reference electrode, wherein the working electrode and the reference electrode are both wires, and wherein the reference electrode is helically wound around the working electrode.
  • the analyte sensor comprises a working electrode, and wherein the working electrode is flexible.
  • the analyte sensor comprises a working electrode, and wherein the working electrode has a variable stiffness.
  • the analyte sensor comprises at least one wire having a helical configuration, and wherein a variable stiffness in the helical wire is provided by at least one of a variable pitch of the helical wire and a variable cross-section of the helical wire.
  • a method for measuring an analyte in a blood stream of a host comprising inserting a vascular access device into communication with a blood stream of a host, wherein the vascular access device comprises an analyte sensor at least partially integrally incorporated therewith; operatively connecting the analyte sensor to sensor electronics; and measuring an analyte concentration in the host.
  • the method further comprises substantially continuously measuring an analyte concentration.
  • the step of measuring an analyte concentration comprises measuring a glucose concentration.
  • the analyte sensor comprises at least one working electrode, wherein the measuring step comprises measuring a first signal at the working electrode, wherein the first signal is substantially analyte-related.
  • the analyte sensor further comprises a second working electrode
  • the measuring step further comprises measuring a second signal at the second working electrode, wherein the second signal is substantially non-analyte related.
  • the method further comprises processing the second signal and the first signal to determine a concentration of an analyte.
  • the measuring step comprises measuring an analyte concentration in an in vivo blood stream of the host.
  • the operatively connecting step comprises connecting the analyte sensor to at least a portion of the sensor electronics via a wired connection.
  • the operatively connecting step comprises connecting the analyte sensor to at least a portion of the sensor electronics via a wireless connection.
  • a method for manufacturing an analyte sensor configured for measuring an analyte in a vascular system of a host is provided, the method comprising providing a vascular access device; and at least partially integrally incorporating an analyte sensor in the vascular access device or on a surface of the vascular access device.
  • the step of at least partially integrally incorporating an analyte sensor comprises depositing at least one working electrode on an interior surface of the vascular access device or on an exterior surface of the vascular access device.
  • the depositing step further comprises electroplating the working electrode onto the exterior surface of the vascular access device.
  • the step of at least partially integrally incorporating an analyte sensor further comprises depositing a second working electrode on an interior surface of the vascular access device or on an exterior surface of the vascular access device.
  • the step of at least partially integrally incorporating an analyte sensor further comprises depositing a reference electrode on an interior surface of the vascular access device or on an exterior surface of the vascular access device.
  • the step of at least partially integrally incorporating an analyte sensor further comprises depositing a counter electrode on an interior surface of the vascular access device or on an exterior surface of the vascular access device.
  • the surface of the vascular access device is selected from the group consisting of an exterior surface, an interior surface, and a tip surface.
  • the step of at least partially integrally incorporating an analyte sensor further comprises forming a reference electrode at a location remote from the working electrode.
  • a method for calibrating a continuous analyte sensor in a host comprising inserting a continuous analyte sensor into a host; contacting a calibration solution with at least a portion of the continuous analyte sensor; and calibrating the continuous analyte sensor to provide calibrated analyte sensor data comprising at least one calibrated sensor data point.
  • the continuous analyte sensor is configured to indwell within a blood stream of a host.
  • the continuous analyte sensor is configured to measure a glucose concentration in the host.
  • the calibration solution comprises a predetermined amount of glucose.
  • the method further comprises displaying the calibrated analyte sensor data.
  • the method further comprises contacting an additional calibration solution with at least a portion of the continuous analyte sensor.
  • the method further comprises calibrating or re-calibrating the continuous analyte sensor to provide calibrated analyte sensor data comprising at least one calibrated sensor data point.
  • the step of contacting an additional calibration solution is repeated.
  • the step of contacting an additional calibration solution is performed automatically.
  • the step of contacting an additional calibration solution is performed manually.
  • the method further comprises contacting a non-analyte solution with at least a portion of the continuous analyte sensor to flush the sensor.
  • the step of contacting a non-analyte solution is performed prior to the step of contacting a calibration solution with at least a portion of the continuous analyte sensor.
  • a method for calibrating a continuous analyte sensor in a host comprising inserting a continuous analyte sensor system into a host; withdrawing at least one blood sample from the host; measuring a reference analyte value from the blood sample; and calibrating the continuous analyte sensor to provide calibrated analyte sensor data comprising at least one calibrated sensor data point.
  • the continuous analyte sensor is configured to indwell within a blood stream of the host.
  • the continuous analyte sensor is configured to measure a glucose concentration of the host.
  • the step of withdrawing at least one blood sample from the host is performed automatically.
  • the step of inserting a continuous analyte sensor comprises inserting a vascular access device into communication with a vascular system of the host, wherein the sensor is integrally incorporated with the vascular access device.
  • the step of withdrawing comprises withdrawing a blood sample through the vascular access device.
  • the method further comprises inserting a vascular access device into communication with a vascular system of the host, wherein the sensor is inserted through the vascular access device.
  • the step of withdrawing comprises withdrawing a blood sample through the vascular access device.
  • the method further comprises displaying the calibrated sensor data.
  • the method further comprises coupling a blood chemistry device to the continuous analyte sensor system.
  • the blood chemistry device performs the step of analyzing at least one blood sample from the host.
  • the blood chemistry device performs the step of measuring a reference analyte value from the blood sample.
  • a continuous analyte sensor system comprising a continuous analyte sensor configured for insertion into a host; and a computer system operatively connected to the continuous analyte sensor, wherein the computer system is configured to receive analyte sensor data from the continuous analyte sensor, the analyte sensor data comprising at least one sensor data point and calibration information, and wherein the computer system is configured to calibrate the analyte sensor data from the calibration information.
  • the analyte sensor is a glucose sensor.
  • the continuous analyte sensor comprises a vascular access device configured for communication with a vascular system of the host, and wherein the continuous analyte sensor is configured to extend through the vascular access device, wherein the analyte sensor is configured to measure a concentration of an analyte within a vascular system of the host.
  • the vascular access device is configured to operatively couple to a blood chemistry analysis device for measuring a blood chemistry of the host.
  • the blood chemistry device is configured to withdraw a blood sample through the vascular access device, and wherein the calibration information comprises the blood sample or a measurement associated therewith.
  • the blood chemistry device is configured to measure a reference analyte value from the host, and wherein the calibration information comprises the reference analyte value.
  • system further comprises a device configured to automatically obtain the calibration information, wherein the device is operatively coupled to the sensor system.
  • the continuous analyte sensor comprises a vascular access device configured for communication with a vascular system of the host, wherein the vascular access device comprises an analyte sensor at least partially integrally incorporated on an exterior surface the vascular access device and further comprises sensor electronics operatively connected to the analyte sensor, wherein the sensor electronics are configured to measure a concentration of an analyte within a blood stream of the host.
  • the vascular access device is configured to operatively couple to a blood chemistry analysis device for measuring a blood chemistry of the host.
  • the blood chemistry device is configured to withdraw a blood sample through the vascular access device, and wherein the calibration information comprises the blood sample or a measurement associated therewith.
  • the blood chemistry device is configured to measure a reference analyte value from the host, and wherein the calibration information comprises the reference analyte value.
  • system further comprises a device configured to automatically obtain the calibration information, wherein the device is operatively coupled to the sensor system.
  • the analyte sensor comprises a working electrode and a reference electrode, and wherein at least one of the working electrode and the reference electrode comprises a wire.
  • the analyte sensor comprises a working electrode and a reference electrode, wherein the working electrode and the reference electrode are both wires, and wherein the wires are coaxial.
  • the analyte sensor comprises a working electrode and a reference electrode, wherein the working electrode and the reference electrode are both wires, and wherein the wires are juxtapositioned.
  • the analyte sensor comprises a working electrode and a reference electrode, wherein the working electrode and the reference electrode are both wires, and wherein the reference electrode is helically wound around the working electrode.
  • the analyte sensor comprises a working electrode, and wherein the working electrode is flexible.
  • the analyte sensor comprises a working electrode, and wherein the working electrode has a variable stiffness.
  • the analyte sensor comprises at least one wire having a helical configuration, and wherein a variable stiffness in the helical wire is provided by at least one of a variable pitch of the helical wire and a variable cross-section of the helical wire.
  • FIG. 1A is a perspective view of one embodiment of an analyte sensor system, including a vascular access device (e.g., a catheter), a sensor, a fluid connector, and a protective sheath.
  • a vascular access device e.g., a catheter
  • sensor e.g., a sensor
  • fluid connector e.g., a fluid connector
  • protective sheath e.g., a sheath
  • FIG. 1B is a side view of the analyte sensor system of FIG. 1A , showing the protective sheath removed.
  • FIG. 1 C 1 is a close-up cut away view of a portion of the analyte sensor system of FIG. 1A .
  • FIG. 1 C 2 is a close-up cut away view of a portion of the analyte sensor system of FIG. 1A .
  • FIG. 1D is a close-up cut away view of a portion of the analyte sensor system of FIG. 1A .
  • FIG. 1E is a close-up cut away view of a portion of the analyte sensor system of FIG. 1A .
  • FIG. 2A is a perspective view of another embodiment of the analyte sensor system, including a catheter with a sensor integrally formed thereon.
  • FIG. 2B is a perspective view of the analyte sensor system of FIG. 2A .
  • FIG. 2C is a close-up view of a portion of the analyte sensor system of FIG. 2A in an alternative configuration of an embodiment having three electrodes disposed on the catheter.
  • FIG. 2D is a close-up view of a portion of the analyte sensor system of FIG. 2A in an alternative configuration of an embodiment having three electrodes disposed on the catheter.
  • FIG. 2E is a close-up view of a portion of the analyte sensor system of FIG. 2A in an alternative embodiment having two electrodes disposed on the catheter.
  • FIG. 2F is a close-up view of a portion of the analyte sensor system of FIG. 2A in an alternative embodiment having one electrode disposed on the catheter.
  • FIG. 3A is a perspective view of a first portion of one embodiment of an analyte sensor.
  • FIG. 3B is a perspective view of a second portion of the analyte sensor of FIG. 3A .
  • FIG. 3C is a cross section of the analyte sensor of FIG. 3B , taken on line C-C.
  • FIG. 4 is a graph illustrating in vivo function of an analyte sensor system of the embodiment shown in FIG. 1A .
  • FIG. 5 is a graph illustrating in vivo function of an analyte sensor system of the embodiment shown in FIG. 1A .
  • analyte as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a substance or chemical constituent in a biological fluid (for example, blood, interstitial fluid, cerebral spinal fluid, lymph fluid or urine) that can be analyzed. Analytes can include naturally occurring substances, artificial substances, metabolites, and/or reaction products. In some embodiments, the analyte for measurement by the sensing regions, devices, and methods is glucose.
  • analytes are contemplated as well, including but not limited to acarboxyprothrombin; acylcarnitine; adenine phosphoribosyl transferase; adenosine deaminase; albumin; alpha-fetoprotein; amino acid profiles (arginine (Krebs cycle), histidine/urocanic acid, homocysteine, phenylalanine/tyrosine, tryptophan); andrenostenedione; antipyrine; arabinitol enantiomers; arginase; benzoylecgonine (cocaine); biotinidase; biopterin; c-reactive protein; camitine; camosinase; CD4; ceruloplasmin; chenodeoxycholic acid; chloroquine; cholesterol; cholinesterase; conjugated 1- ⁇ hydroxy-cholic acid; cortisol; creatine kinase; creatine kinase MM
  • Salts, sugar, protein, fat, vitamins, and hormones naturally occurring in blood or interstitial fluids can also constitute analytes in certain embodiments.
  • the analyte can be naturally present in the biological fluid, for example, a metabolic product, a hormone, an antigen, an antibody, and the like.
  • the analyte can be introduced into the body, for example, a contrast agent for imaging, a radioisotope, a chemical agent, a fluorocarbon-based synthetic blood, or a drug or pharmaceutical composition, including but not limited to insulin; ethanol; cannabis (marijuana, tetrahydrocannabinol, hashish); inhalants (nitrous oxide, amyl nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons); cocaine (crack cocaine); stimulants (amphetamines, methamphetamines, Ritalin, Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine); depressants (barbituates, methaqualone, tranquilizers such as Valium, Librium, Miltown, Serax, Equanil, Tranxene); hallucinogens (phencyclidine, lysergic acid, mescaline, peyote, p
  • Analytes such as neurochemicals and other chemicals generated within the body can also be analyzed, such as, for example, ascorbic acid, uric acid, dopamine, noradrenaline, 3-methoxytyramine (3MT), 3,4-dihydroxyphenylacetic acid (DOPAC), homovanillic acid (HVA), 5-hydroxytryptamine (5HT), histamine, Advanced Glycation End Products (AGEs) and 5-hydroxyindoleacetic acid (FHIAA).
  • ascorbic acid uric acid
  • dopamine dopamine
  • noradrenaline 3-methoxytyramine (3MT)
  • 3-methoxytyramine (3MT) 3,4-dihydroxyphenylacetic acid
  • DOPAC 3,4-dihydroxyphenylacetic acid
  • HVA homovanillic acid
  • 5HT 5-hydroxytryptamine
  • histamine histamine
  • AGEs Advanced Glycation End Products
  • FHIAA 5-hydroxyindoleacetic acid
  • host as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to animals or plants, for example humans.
  • continuous (or continual) analyte sensing is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to the period in which monitoring of analyte concentration is continuously, continually, and or intermittently (regularly or irregularly) performed, for example, about every 5 to 10 minutes.
  • electrochemically reactive surface is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a surface where an electrochemical reaction takes place.
  • a working electrode measures hydrogen peroxide produced by the enzyme-catalyzed reaction of the analyte detected, which reacts to create an electric current.
  • Glucose analyte can be detected utilizing glucose oxidase, which produces H 2 O 2 as a byproduct.
  • H 2 O 2 reacts with the surface of the working electrode, producing two protons (2H + ), two electrons (2 e ⁇ ) and one molecule of oxygen (O 2 ), which produces the electronic current being detected.
  • Electrode connection is broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refer without limitation to any connection between two electrical conductors known to those in the art.
  • electrodes are in electrical connection with the electronic circuitry of a device.
  • sensing region is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to the region of a monitoring device responsible for the detection of a particular analyte.
  • the sensing region generally comprises a non-conductive body, a working electrode (anode), and can include a reference electrode (optional), and/or a counter electrode (cathode) forming electrochemically reactive surfaces on the body.
  • domain is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a region of the membrane system that can be a layer, a uniform or non-uniform gradient (for example, an anisotropic region of a membrane), or a portion of a membrane.
  • distal to is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to the spatial relationship between various elements in comparison to a particular point of reference. In general, the term indicates an element is located relatively far from the reference point than another element.
  • proximal to is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to the spatial relationship between various elements in comparison to a particular point of reference. In general, the term indicates an element is located relatively near to the reference point than another element.
  • in vivo portion is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a portion of a device (for example, a sensor) adapted for insertion into and/or existence within a living body of a host.
  • a device for example, a sensor
  • ex vivo portion is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a portion of a device (for example, a sensor) adapted to remain and/or exist outside of a living body of a host.
  • raw data is broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to an analog or digital signal from the analyte sensor directly related to the measured analyte.
  • the raw data stream is digital data in “counts” converted by an A/D converter from an analog signal (for example, voltage or amps) representative of an analyte concentration.
  • the terms can include a plurality of time spaced data points from a substantially continuous analyte sensor, each of which comprises individual measurements taken at time intervals ranging from fractions of a second up to, for example, 1, 2, or 5 minutes or longer.
  • the terms can refer to data that has been integrated or averaged over a time period (e.g., 5 minutes).
  • count is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a unit of measurement of a digital signal.
  • a raw data stream or raw data signal measured in counts is directly related to a voltage (for example, converted by an A/D converter), which is directly related to current from the working electrode.
  • the terms can refer to data that has been integrated or averaged over a time period (e.g., 5 minutes).
  • sensor and “sensor system” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to a device, component, or region of a device by which an analyte can be quantified.
  • needle as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a slender hollow instrument for introducing material into or removing material from the body.
  • operatively connected operatively linked
  • operably connected operatively linked
  • operably linked refers without limitation to one or more components linked to one or more other components.
  • the terms can refer to a mechanical connection, an electrical connection, or any connection that allows transmission of signals between the components.
  • one or more electrodes can be used to detect the amount of analyte in a sample and to convert that information into a signal; the signal can then be transmitted to a circuit.
  • the electrode is “operably linked” to the electronic circuitry.
  • the terms include wired and wireless connections.
  • membrane and “membrane system” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to a permeable or semi-permeable membrane that can be comprised of one or more domains and is typically constructed of materials of one or more microns in thickness, which is permeable to oxygen and to an analyte, e.g., glucose or another analyte.
  • the membrane system comprises an immobilized glucose oxidase enzyme, which enables a reaction to occur between glucose and oxygen whereby a concentration of glucose can be measured.
  • processor module and “microprocessor” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to a computer system, state machine, processor, and the like designed to perform arithmetic or logic operations using logic circuitry that responds to and processes the basic instructions that drive a computer.
  • calibration is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to the relationship and/or process of determining the relationship between the sensor data and the corresponding reference data, which can be used to convert sensor data into values substantially equivalent to the reference data.
  • calibration can be updated or recalibrated over time if changes in the relationship between the sensor data and reference data occur, for example, due to changes in sensitivity, baseline, transport, metabolism, and the like.
  • interferents and “interfering species” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to effects and/or species that interfere with the measurement of an analyte of interest in a sensor to produce a signal that does not accurately represent the analyte concentration.
  • interfering species are compounds with an oxidation potential that substantially overlaps that of the analyte to be measured, thereby producing a false positive signal.
  • single point glucose monitor is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a device that can be used to measure a glucose concentration within a host at a single point in time, for example, some embodiments utilize a small volume in vitro glucose monitor that includes an enzyme membrane such as described with reference to U.S. Pat. No. 4,994,167 and U.S. Pat. No. 4,757,022. It should be understood that single point glucose monitors can measure multiple samples (for example, blood, or interstitial fluid); however only one sample is measured at a time and typically requires some user initiation and/or interaction.
  • biological sample as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to sample of a host body, for example blood, interstitial fluid, spinal fluid, saliva, urine, tears, sweat, tissue, fat, and the like.
  • casting is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a process where a fluid material is applied to a surface or surfaces and allowed to cure or dry.
  • the term is broad enough to encompass a variety of coating techniques, for example, using a draw-down machine (i.e., drawing-down), dip coating, spray coating, spin coating, and the like.
  • dip coating is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to coating, which involves dipping an object or material into a liquid coating substance.
  • spray coating is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to coating, which involves spraying a liquid coating substance onto an object or material.
  • spin coating is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a coating process in which a thin film is created by dropping a raw material solution onto a substrate while it is rotating.
  • solvent and “solvent system” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to substances (e.g., liquids) capable of dissolving or dispersing one or more other substances.
  • Solvents and solvent systems can include compounds and/or solutions that include components in addition to the solvent itself.
  • baseline is composed substantially of signal contribution due to factors other than glucose (for example, interfering species, non-reaction-related hydrogen peroxide, or other electroactive species with an oxidation potential that overlaps with hydrogen peroxide).
  • sensitivity and “slope” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to an amount of electrical current produced by a predetermined amount (unit) of the measured analyte.
  • a glucose sensor has a sensitivity (or slope) of about 3.5 to about 7.5 picoAmps of current for every 1 mg/dL of glucose.
  • baseline and/or sensitivity shift baseline and/or sensitivity drift
  • shift baseline and/or sensitivity drift
  • drift drift
  • drift drift
  • hypoglycemia is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refers without limitation to a condition in which a limited or low amount of glucose exists in a host.
  • Hypoglycemia can produce a variety of symptoms and effects but the principal problems arise from an inadequate supply of glucose as fuel to the brain, resulting in impairment of function (neuroglycopenia). Derangements of function can range from vaguely “feeling bad” to coma, and (rarely) permanent brain damage or death.
  • hyperglycemia is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refers without limitation to a condition in which an excessive or high amount of glucose exists in a host.
  • Hyperglycemia is one of the classic symptoms of diabetes mellitus. Non-diabetic hyperglycemia is associated with obesity and certain eating disorders, such as bulimia nervosa. Hyperglycemia is also associated with other diseases (or medications) affecting pancreatic function, such as pancreatic cancer. Hyperglycemia is also associated with poor medical outcomes in a variety of clinical settings, such as intensive or critical care settings.
  • potentiostat as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to an electronic instrument that controls the electrical potential between the working and reference electrodes at one or more preset values.
  • a potentiostat works to keep the potential constant by noticing changes in the resistance of the system and compensating inversely with a change in the current. As a result, a change to a higher resistance would cause the current to decrease to keep the voltage constant in the system.
  • a potentiostat forces whatever current is necessary to flow between the working and counter electrodes to keep the desired potential, as long as the needed cell voltage and current do not exceed the compliance limits of the potentiostat.
  • the terms “electronics” and “sensor electronics” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to electronics operatively coupled to the sensor and configured to measure, process, receive, and/or transmit data associated with a sensor.
  • the electronics include at least a potentiostat that provides a bias to the electrodes and measures a current to provide the raw data signal.
  • the electronics are configured to calculate at least one analyte sensor data point.
  • the electronics can include a potentiostat, A/D converter, RAM, ROM, and/or transmitter.
  • the potentiostat converts the raw data (e.g., raw counts) collected from the sensor and converts it to a value familiar to the host and/or medical personnel.
  • the raw counts from a glucose sensor can be converted to milligrams of glucose per deciliter of blood (e.g., mg/dl).
  • the sensor electronics include a transmitter that transmits the signals from the potentiostat to a receiver, where additional data analysis and glucose concentration determination can occur.
  • Coupled and “operatively coupling” as used herein are broad terms, and are to be given their ordinary and customary meanings to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to a joining or linking together of two or more things, such as two parts of a device or two devices, such that the things can function together.
  • two containers can be operatively coupled by tubing, such that fluid can flow from one container to another. Coupling does not imply a physical connection.
  • a transmitter and a receiver can be operatively coupled by radio frequency (RF) transmission/communication.
  • RF radio frequency
  • fluid communication is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refers without limitation to two or more components (e.g., things such as parts of a body or parts of a device) functionally linked such that fluid can move from one component to another. These terms do not imply directionality.
  • continuous and “continuously” as used herein are broad terms, and are to be given their ordinary and customary meanings to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to the condition of being marked by substantially uninterrupted extension in space, time or sequence.
  • an analyte concentration is measured continuously or continually, for example at time intervals ranging from fractions of a second up to, for example, 1, 2, or 5 minutes, or longer.
  • continuous glucose sensors generally continually measure glucose concentration without required user initiation and/or interaction for each measurement, such as described with reference to U.S. Pat. No. 6,001,067, for example. These terms include situations wherein data gaps can exist (e.g., when a continuous glucose sensor is temporarily not providing data).
  • medical device as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refers without limitation to an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals.
  • Medical devices that can be used in conjunction with various embodiments of the analyte sensor system include any monitoring device requiring placement in a human vessel, duct or body cavity, a dialysis machine, a heart-lung bypass machine, blood collection equipment, a blood pressure monitor, an automated blood chemistry analysis device and the like.
  • blood pressure monitor is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refers without limitation to an instrument for monitoring the blood pressure of a human or other animal.
  • a blood pressure monitor can be an invasive blood pressure monitor, which periodically monitors the host's blood pressure via a peripheral artery, using a blood pressure transducer, such as but not limited to a disposable blood pressure transducer.
  • Utah Medical Products Inc. (Midvale, Utah, USA) produces a variety of Deltran® Brand disposable blood pressure transducers that are suitable for use with various embodiments disclosed herein.
  • pressure transducer as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refers without limitation to a component of an intra-arterial blood pressure monitor that measures the host's blood pressure.
  • blood chemistry analysis device is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refers without limitation to a device that measures a variety of blood components, characteristics or analytes therein.
  • a blood chemistry analysis device periodically withdraws an aliquot of blood from the host, measures glucose, O 2 , CO 2 , PCO 2 , PO 2 , potassium, sodium, pH, lactate, urea, bilirubin, creatinine, hematocrit, various minerals, and/or various metabolites, and the linke, and returns the blood to the host's circulatory system.
  • vascular access device as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refers without limitation to any device that is in communication with the vascular system of a host.
  • Vascular access devices include but are not limited to catheters, shunts, blood withdrawal devices and the like.
  • catheter as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refers without limitation to a tube that can be inserted into a host's body (e.g., cavity, duct or vessel). In some circumstances, catheters allow drainage or injection of fluids or access by medical instruments or devices.
  • a catheter is a thin, flexible tube (e.g., a “soft” catheter). In alternative embodiments, the catheter can be a larger, solid tube (e.g., a “hard” catheter).
  • cannula is interchangeable with the term “catheter” herein.
  • indwell is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refers without limitation to reside within a host's body.
  • Some medical devices can indwell within a host's body for various lengths of time, depending upon the purpose of the medical device, such as but not limited to a few hours, days, weeks, to months, years, or even the host's entire lifetime.
  • an arterial catheter may indwell within the host's artery for a few hours, days, a week, or longer, such as but not limited to the host's perioperative period (e.g., from the time the host is admitted to the hospital to the time he is discharged).
  • sheath as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refers without limitation to a covering or supporting structure that fits closely around something, for example, in the way that a sheath covers a blade.
  • a sheath is a slender, flexible, polymer tube that covers and supports a wire-type sensor prior to and during insertion of the sensor into a catheter.
  • slot is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refers without limitation to a relatively narrow opening.
  • Intensive care medicine or critical care medicine is concerned with providing greater than ordinary medical care and/or observation to people in a critical or unstable condition.
  • People requiring intensive care include those recovering after major surgery, with severe head trauma, life-threatening acute illness, respiratory insufficiency, coma, haemodynamic insufficiency, severe fluid imbalance or with the failure of one or more of the major organ systems (life-critical systems or others).
  • ICUs intensive care units
  • CCUs critical care units
  • Intensive care is generally the most expensive, high technology and resource intensive area of medical care. In the United States estimates of the year 2000 expenditure for critical care medicine ranged from $15-55 billion accounting for about 0.5% of GDP and about 13% of national health care expenditure. As the U.S. population ages, these costs will increase substantially. Accordingly, there is an urgent need to reducing costs while at the same time reducing ICU/CCU mortality rates by improving care.
  • Some embodiments disclosed herein are suitable for use in an intensive care or critical care unit of a medical care facility for substantially continuously measuring a host's analyte concentration.
  • Hyperglycemia is a medical condition in which an excessive amount of glucose circulates in a host. Medical studies suggest a relationship between hyperglycemia and host outcome in intensive/critical care settings. For example, perioperative hyperglycemia is associated with increased rates and severity of myocardial infarction (MI) and stroke, while tight glucose control with intravenous (IV) insulin therapy is linked to a 30% reduction in mortality one year after admission for acute MI. Furthermore, strict in-hospital glucose control is associated with 40% reductions of morbidity, mortality, sepsis, dialysis, blood transfusions, as well as reduced length of stay, reduced costs and the like.
  • MI myocardial infarction
  • IV intravenous
  • Hyperglycemia can also be an issue in non-critical care settings, such as in the general hospital population, such as for diabetes hosts admitted for non-glucose-related medical conditions, or in clinical settings, such as the doctor's office, such as during glucose challenge tests, or treatment of the elderly or the very young, or others who may have difficulty with glucose control.
  • hypoglycemia can cause shock and death (immediate problems)
  • the clinical staff rigorously avoids it, often by maintaining the host at elevated blood glucose concentrations (which can degrade the clinical outcome in the long run) and causes the problems of hyperglycemia discussed above.
  • Hyperglycemia can be managed in a variety of ways.
  • hyperglycemia is managed with sliding-scale IV insulin, that stops insulin delivery at about 150 to 200 mg/dl. This generally requires monitoring by a nurse (using a hand-held clinical glucose meter) and insulin administration at least every six hours. Maintaining tight glucose control within the normal range (e.g., 80-110 mg/dl) currently requires hourly or even more frequent monitoring and insulin administration. This places an undue burden on the nursing staff.
  • the preferred embodiments provide devices and methods for automated, continuous glucose monitoring (e.g., indwelling in the circulatory system), to enable tight glucose control.
  • the in vivo continuous analyte monitoring system of the preferred embodiments can be used in clinical settings, such as in the hospital, the doctor's office, long-term nursing facilities, or even in the home.
  • the present device can be used in any setting in which frequent or continuous analyte monitoring is desirable.
  • hosts are often recovering from serious illness, disease, or surgery, and control of host glucose levels is important for host recovery.
  • Use of an in-dwelling continuous glucose monitor allows tight control of host glucose concentration and improved host care, while reducing hypoglycemic episodes and reducing the ICU staff work load.
  • the system can be used for the entire hospital stay or for only a part of the hospital stay.
  • the in-dwelling continuous glucose monitor can be used in an ER setting.
  • a host may be unable to communicate with the staff.
  • Routine use of a continuous analyte monitor e.g., glucose, creatinine, phosphate, electrolytes, or drugs
  • analyte concentration changes indicative of the host's condition e.g., the host's glucose concentration
  • a continuous analyte monitor can be used in the general hospital population to monitor host analyte concentrations, for various lengths of time, such as during the entire hospital stay or for a portion of the hospital stay (e.g., only during surgery).
  • a diabetic host's glucose concentration can be monitored during his entire stay.
  • a cardiac host's glucose can be monitored during surgery and while in the ICU, but not after being moved to the general host population.
  • a jaundiced newborn infant can have his bilirubin concentration continuously monitored by an in-dwelling continuous analyte monitor until the condition has receded.
  • the analyte sensor of the preferred embodiments can be used in other body locations.
  • the sensor is used subcutaneously.
  • the sensor can be used intracranially.
  • the sensor can be used within the spinal compartment, such as but not limited to the epidural space.
  • the sensor of the preferred embodiments can be used with or without a catheter.
  • One aspect of the preferred embodiments provides a system for in vivo continuous analyte monitoring (e.g., glucose, O 2 , CO 2 , PCO 2 , PO 2 , potassium, sodium, pH, lactate, urea, bilirubin, creatinine, hematocrit, various minerals, various metabolites, and the like) that can be operatively coupled to a catheter to measure analyte concentration within the host's blood stream.
  • the system includes an analyte sensor that extends a short distance into the blood stream (e.g., out of the catheter) without substantially occluding the catheter or the host's blood stream.
  • the catheter can be fluidly coupled to additional IV and diagnostic devices, such as a saline bag, an automated blood pressure monitor, or a blood chemistry monitor device.
  • additional IV and diagnostic devices such as a saline bag, an automated blood pressure monitor, or a blood chemistry monitor device.
  • blood samples can be removed from the host via the sensor system, as described elsewhere herein.
  • the sensor is a glucose sensor, and the medical staff monitors the host's glucose level.
  • FIGS. 1A to 1E illustrate one embodiment of an exemplary analyte sensor system 10 for measuring an analyte (e.g., glucose, urea, potassium, pH, proteins, etc.) that includes a catheter 12 configured to be inserted or pre-inserted into a host's blood stream.
  • analyte e.g., glucose, urea, potassium, pH, proteins, etc.
  • catheters are often inserted into hosts to allow direct access to the circulatory system without frequent needle insertion (e.g., venipuncture).
  • Suitable catheters can be sized as is known and appreciated by one skilled in the art, such as but not limited to from about 1 French (0.33 mm) or less to about 30 French (10 mm) or more; and can be, for example, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 French (3 French is equivalent to about 1 mm).
  • the catheter can be manufactured of any medical grade material known in the art, such as but not limited to polymers and glass as described herein.
  • a catheter can include a single lumen or multiple lumens.
  • a catheter can include one or more perforations, to allow the passage of host fluid through the lumen of the catheter.
  • inserted or “pre-inserted” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to insertion of one thing into another thing.
  • a catheter can be inserted into a host's blood stream.
  • a catheter is “pre-inserted,” meaning inserted before another action is taken (e.g., insertion of a catheter into a host's blood stream prior to insertion of a sensor into the catheter).
  • a sensor is coupled to a pre-inserted catheter, namely, one that has been previously inserted (or pre-inserted) into the host's circulatory system.
  • the catheter 12 is a thin, flexible tube having a lumen 12 a, such as is known in the art.
  • the catheter can be rigid; in other embodiments, the catheter can be custom manufactured to desired specifications (e.g., rigidity, dimensions, etc).
  • the catheter can be a single-lumen catheter or a multi-lumen catheter.
  • a small orifice 12 b for fluid connection of the catheter to the blood stream.
  • a connector 18 such as a leur connector or other fluid connector known in the art.
  • FIGS. 1A to 1E show one exemplary embodiment of the connector 18 including a flange 18 a and a duct 18 b.
  • the flange 18 a is configured to enable connection of the catheter to other medical equipment (e.g., saline bag, pressure transducer, blood chemistry device, and the like) or capping (e.g., with a bung and the like).
  • other medical equipment e.g., saline bag, pressure transducer, blood chemistry device, and the like
  • capping e.g., with a bung and the like.
  • the duct 18 b is in fluid communication with the catheter lumen and terminates in a connector orifice 18 c.
  • the catheter is inserted into the host's blood stream, such as into a vein or artery by any useful method known in the art.
  • the catheter is supported by a hollow needle or trochar (not shown).
  • the supported catheter can be inserted into a peripheral vein or artery, such as in the host's arm, leg, hand, or foot.
  • the supporting needle is removed (e.g., pulled out of the connector) and the catheter is connected (e.g., via the connector 18 ) to IV tubing and a saline drip, for example.
  • the catheter is configured to operatively couple to medical equipment, such as but not limited to a sensor system of the preferred embodiments.
  • the catheter can be configured to operatively couple to another medical device, such as a pressure transducer, for measurement of the host's blood pressure.
  • the catheter and the analyte sensor are configured to indwell within the host's blood stream in vivo.
  • An indwelling medical device such as a catheter or implant, is disposed within a portion of the body for a period of time, from a few minutes or hours to a few days, months, or even years.
  • An indwelling catheter is typically inserted within a host's vein or artery for a period of time, often 2 or more days, a month, or even a few months.
  • the catheter can indwell in a host's artery or vein for the length of a perioperative period (e.g., the entire hospital stay) or for shorter or longer periods.
  • an indwelling catheter permits continuous access of an analyte sensor to a blood stream while simultaneously allowing continuous access to the host's blood stream for other purposes, for example, the administration of therapeutics (e.g., fluids, drugs, etc.), measurement of physiologic properties (e.g., blood pressure), fluid removal, and the like.
  • therapeutics e.g., fluids, drugs, etc.
  • measurement of physiologic properties e.g., blood pressure
  • fluid removal e.g., and the like.
  • the system 10 also includes an analyte sensor 14 configured to extend through the catheter lumen 12 a (see FIG. 1E ), out of the catheter orifice 12 b and into the host's blood stream by about 0.010 inches to about 1 inch, or shorter or longer lengths.
  • the sensor may not extend out of the catheter, for example, can reside just inside the catheter tip.
  • the sensor can extend through the catheter in any functional manner.
  • the sensor is configured to be held on an inner surface (e.g., the lumen) or outer surface of the catheter, while in other embodiments, the sensor is configured to “free float” within the lumen of the catheter.
  • the senor 14 is configured to measure the concentration of an analyte (e.g., glucose, O 2 , CO 2 , PCO 2 , PO 2 , potassium, sodium, pH, lactate, urea, bilirubin, creatinine, hematocrit, various minerals, various metabolites, and the like) within the host's blood stream.
  • an analyte e.g., glucose, O 2 , CO 2 , PCO 2 , PO 2
  • potassium sodium, pH, lactate, urea, bilirubin, creatinine, hematocrit, various minerals, various metabolites, and the like
  • the sensor includes at least one electrode (see, e.g., FIG. 3B ), for example a working electrode; however any combination of working electrode(s), reference electrode(s), and/or counter electrode(s) can be implemented as is appreciated by one skilled in the art.
  • the senor 14 includes at least one exposed electroactive area (e.g., working electrode), a membrane system (e.g., including an enzyme), a reference electrode (proximal to or remote from the working electrode), and an insulator material.
  • a membrane system e.g., including an enzyme
  • a reference electrode proximal to or remote from the working electrode
  • an insulator material e.g., a senor material.
  • the senor is a needle-type continuous analyte sensor, configured as disclosed in U.S. publication US 2006-0020192 and/or U.S. publication US 2006-0036143, both of which are incorporated herein by reference in their entirety.
  • the sensor is configured to measure glucose concentration. Exemplary sensor configurations are discussed in more detail, elsewhere herein.
  • the senor has a proximal end 14 a and a distal end 14 b. At its distal end 14 b, the sensor 14 is associated with (e.g., connected to, held by, extends through, and the like) a fluid coupler 20 having first and second sides ( 20 a and 20 b, respectively). The fluid coupler is configured to mate (via its first side 20 a ) to the catheter connector 18 .
  • a skirt 20 c is located at the fluid coupler's first side and includes an interior surface 20 d with threads 20 e (see FIGS. 1D and 1E ).
  • the fluid coupler is configured to mate with the connector flange 18 a, which is screwed into the fluid coupler via the screw threads.
  • the fluid coupler is configured to mate with the connector using any known mating configuration, for example, a snap-fit, a press-fit, an interference-fit, and the like, and can include a locking mechanism to prevent separation of the connector and fluid coupler.
  • the fluid coupler 20 includes a lumen 20 f extending from a first orifice 20 h on its first side 20 a to a second orifice 20 i located on the fluid coupler's second side 20 b (FIGS. 1 C 1 to 1 E). When the catheter connector is mated with the fluid coupler, the catheter's lumen 12 a is in fluid communication with the fluid coupler's lumen 20 f via orifices 18 c and 20 h.
  • FIGS. 1A to 1D show one embodiment of a fluid coupler 20 , namely, a Y-coupler; however, any known coupler configuration can be used, including but not limited to a straight coupler, a T-coupler, a cross-coupler, a custom configured coupler, and the like.
  • the fluid coupler includes at least one valve (e.g., a septum, a 3-way valve, a stop-cock valve), which can be used for a variety of purposes (e.g., injection of drugs).
  • the fluid coupler can be made of any convenient material, such as but not limited to plastic, glass, metal or combinations thereof and can be configured to withstand known sterilization techniques.
  • the second side 20 b of the fluid coupler 20 is configured to be operably connected to IV equipment, another medical device or to be capped, and can use any known mating configuration, for example, a snap-fit, a press-fit, an interference-fit, and the like.
  • the second side 20 b is configured to mate with a saline drip, for delivery of saline to the host.
  • the saline flows from an elevated bag of sterile saline via tubing, through the fluid coupler, through the catheter and into the host's blood system (e.g., vein or artery).
  • a syringe can be mated to the fluid coupler, for example, to withdraw blood from the host, via the catheter.
  • Additional connection devices e.g., a three-way valve
  • a blood pressure transducer can be operably connected to the fluid coupler, to support additional functionality and connection of various devices, such as but not limited to a blood pressure transducer.
  • the senor 14 passes through the fluid coupler 20 (e.g., the fluid coupler lumen 20 f ) and is operatively connected to sensor electronics (not shown) via a hardwire 24 .
  • the sensor electronics can be disposed in part or in whole with the fluid coupler (e.g., integrally with or proximal to) or can be disposed in part or in whole remotely from the fluid coupler (e.g., on a stand or at the bed side). Connections between the sensor and sensor electronics (in part or in whole) can be accomplished using known wired or wireless technology.
  • the senor is hardwired to the electronics located substantially wholly remote from the fluid coupler (e.g., disposed on a stand or near the bedside); one advantage of remote electronics includes enabling a smaller sized fluid coupler design.
  • a portion of the sensor electronics, such as a potentiostat is disposed on the fluid coupler and the remaining electronics (e.g., electronics for receiving, data processing, printing, connection to a nurses' station, etc.) are disposed remotely from the fluid coupler (e.g., on a stand or near the bedside).
  • One advantage of this design can include more reliable electrical connection with the sensor in some circumstances.
  • the potentiostat can be hardwired directly to the remaining electronics or a transmitter can be disposed on or proximal to the fluid coupler, for remotely connecting the potentiostat to the remaining electronics (e.g., by radio frequency (RF)).
  • RF radio frequency
  • all of the sensor electronics can be disposed on the fluid coupler.
  • the sensor electronics disposed on the fluid coupler include a potentiostat.
  • a protective sheath 26 is configured to cover at least a portion of the sensor 14 during insertion, and includes hub 28 and slot 30 .
  • the protective sheath protects and supports the sensor prior to and during insertion into the catheter 12 via the connector 18 .
  • the protective sheath can be made of biocompatible polymers known in the art, such as but not limited to polyethylene (PE), polyurethane (PE), polyvinyl chloride (PVC), polycarbonate (PC), nylon, polyamides, polyimide, polytetrafluoroethylene (PTFE), Teflon, nylon and the like.
  • the protective sheath includes a hub 28 , for grasping the sheath (e.g., while maintaining sterilization of the sheath).
  • the hub additionally provides for mating with the second side 20 b of the fluid coupler 20 , prior to and during sensor insertion into the catheter.
  • the slot of the protective sheath is configured to facilitate release of the sensor therefrom.
  • the hub is grasped and pulled from the second side of the fluid coupler. This action peels the protective sheath from the sensor (e.g., the sensor slides through the slot as the sheath is removed), leaving the sensor within the catheter.
  • the second side of the fluid coupler can be connected to other medical devices (e.g., a blood pressure monitor) or an IV drip (e.g., a saline drip), or capped.
  • the sheath can fold (e.g., fold back or concertinas) or retract (e.g., telescope) during insertion, to expose the sensor.
  • the sheath can be configured to tear away from the sensor before, during, or after insertion of the sensor.
  • the sheath can include an outlet hole 30 a, to allow protrusion of the sensor from the back end of the sheath (e.g., near the hub 28 ).
  • additional configurations can be used, to separate the sensor 14 from the sheath 26 .
  • the sheath 26 can be optional, depending upon the sensor design.
  • the sensor can be inserted into a catheter or other vascular access device with or without the use of a protective sheath).
  • the sensor can be disposed on the outer surface of a catheter (as described elsewhere herein) or on the inner surface of a catheter; and no sheath is provided.
  • a multi-lumen catheter can be provided with a sensor already disposed within one of the lumens; wherein the catheter is inserted into the host's vein or artery with the sensor already disposed in one of the lumens.
  • an analyte sensor is integrally formed on a catheter.
  • the catheter can be placed into a host's vein or artery in the usual way a catheter is inserted, as is known by one skilled in the art, and the host's analyte concentration measured substantially continuously.
  • the sensor system can be coupled to one or more additional devices, such as a saline bag, an automated blood pressure monitor, a blood chemistry monitor device, and the like.
  • the integrally formed analyte sensor is a glucose sensor.
  • FIGS. 2A to 2B illustrate one exemplary embodiment of an analyte sensor integrally formed on a catheter.
  • the system 210 is configured to measure an analyte (e.g., glucose, O 2 , CO 2 , PCO 2 , PO 2 , potassium, sodium, pH, lactate, urea, bilirubin, creatinine, hematocrit, various minerals, various metabolites, and the like) and generally includes a catheter 212 configured for insertion into a host's blood stream (e.g., via a vein or artery) and a sensor at least partially integrally formed on the catheter's exterior surface 232 .
  • analyte e.g., glucose, O 2 , CO 2 , PCO 2 , PO 2 , potassium, sodium, pH, lactate, urea, bilirubin, creatinine, hematocrit, various minerals, various metabolites, and the like
  • a catheter 212 configured for insertion into a host'
  • the senor 214 includes at least one exposed electroactive area 240 (e.g., a working electrode), a membrane system (e.g., including an enzyme), a reference electrode (proximal to or remote from the working electrode), and an insulator.
  • exposed electroactive area 240 e.g., a working electrode
  • membrane system e.g., including an enzyme
  • reference electrode proximal to or remote from the working electrode
  • the catheter includes a lumen 212 a and an orifice 212 b at its proximal end, for providing fluid connection from the catheter's lumen to the host's blood stream (see FIG. 2A ).
  • the catheter is inserted into a vein, as described elsewhere herein. In other embodiments, the catheter is inserted into an artery, as described elsewhere herein.
  • the catheter can be any type of venous or arterial catheter commonly used in the art (e.g., peripheral catheter, central catheter, Swan-Gantz catheter, etc.).
  • the catheter can be made of any useful medical grade material (e.g., polymers and/or glass) and can be of any size, such as but not limited to from about 1 French (0.33 mm) or less to about 30 French (10 mm) or more; for example, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 French (3 French is equivalent to about 1 mm).
  • the catheter can be a single lumen catheter or a multi-lumen catheter.
  • the catheter can include one or more perforations, to allow the passage of host fluid through the lumen of the catheter.
  • the catheter 212 includes (e.g., in fluid communication) a connector 218 .
  • the connector can be of any known type, such as a leur lock, a T-connector, a Y-connector, a cross-connector or a custom configuration, for example.
  • the connector includes at least one valve.
  • the connector 218 can be operatively connected to a saline system (e.g., saline bag and tubing), other medical devices (e.g., automatic blood chemistry machine, dialysis machine, a blood bag for collecting donated blood, etc.), or capped.
  • a saline system e.g., saline bag and tubing
  • other medical devices e.g., automatic blood chemistry machine, dialysis machine, a blood bag for collecting donated blood, etc.
  • the system 210 includes sensor electronics (not shown) operatively connected to the analyte sensor, wherein the sensor electronics are generally configured to measure and/or process the sensor data as described in more detail elsewhere herein.
  • the sensor electronics can be partially or wholly disposed with (e.g., integral with, disposed on, or proximal to) the connector 218 at the distal end of the catheter or partially or wholly remote from the catheter (e.g., on a stand or on the bedside).
  • the sensor electronics disposed with the connector include a potentiostat.
  • the sensor electronics are configured to measure the host's analyte concentration substantially continuously. For example, the sensor can measure the analyte concentration continuously or at time intervals ranging from fractions of a second up to, for example, 1, 2, or 5 minutes or longer.
  • FIGS. 2C to 2F illustrate additional embodiments of the sensor shown in FIGS. 2A to 2B .
  • the catheter 212 is shown with an integral sensor 214 having at least one electrode 240 formed on its exterior surface 232 (e.g., FIG. 2F ).
  • the sensor can be designed with 1, 2, 3, 4 or more electrodes and can be connected by traces (or the like) to electrical contacts 218 d (or the like) at the second end of the connector 218 (e.g., FIGS. 2A to 2F ).
  • the sensor is hard-wired to the sensor electronics; alternatively, any operable connection can be used.
  • the sensor includes at least one working electrode and at least one reference or counter electrode.
  • the reference electrode is located proximal to the at least one working electrode (e.g., adjacent to or near to the working electrode). In some alternative embodiments, the reference electrode is located remotely from the working electrode (e.g., away from the working electrode, such as but not limited to within the lumen of the catheter 212 (or connector 218 ), on the exterior of the sensor system, in contact with the patient (e.g., on the skin), or the like). In some embodiments, the reference electrode is located proximal to or within the fluid connector, such as but not limited to coiled about the catheter adjacent to the fluid connector or coiled within the fluid connector and in contact with fluid flowing through the fluid coupler, such as saline or blood.
  • the senor can also include one or more additional working electrodes (e.g., for measuring baseline, for measuring a second analyte, or for measuring a substantially non-analyte related signal, and the like, such as described in more detail in co-pending U.S. Publication No. US-2005-0143635-A1, and U.S. patent application Ser. No. ______ filed on even date herewith and entitled “DUAL ELECTRODE SYSTEM FOR A CONTINUOUS ANALYTE SENSOR,” which are incorporated herein by reference in their entirety.
  • one or more counter electrodes can be provided on a surface of the catheter or within or on the fluid connector.
  • the catheter is designed to indwell within a host's blood flow (e.g., a peripheral vein or artery) and remain in the blood flow for a period of time (e.g., the catheter is not immediately removed).
  • a host's blood flow e.g., a peripheral vein or artery
  • the indwelling catheter can be inserted into the blood flow for example, for a few minutes or more, between about 1 and 24 hours, between about 1 and 10 days, or even longer.
  • the catheter can indwell in the host's blood stream during an entire perioperative period (e.g., from host admittance, through an operation, and to release from the hospital).
  • the catheter is configured as an intravenous catheter (e.g., configured to be inserted into a vein).
  • the catheter can be inserted into any commonly used vein, such as in a peripheral vein (e.g., one of the metacarpal veins of the arm); in some embodiments (e.g., such as described with reference to FIGS. 1A to 1E ) the analyte sensor inserted into a catheter.
  • the sensor is integrally formed on a catheter such as described in more detail with reference to FIGS. 2A to 2F , for example.
  • Other veins such as leg or foot veins, hand veins, or even scalp or umbilical veins, can also be used.
  • the intravenous catheter can be used for delivery of fluids and/or drugs to the host's circulatory system.
  • the catheter can be configured to be coupled to other medical devices or functions, for example, saline, blood products, total parenteral feeding or medications can be given to the host via the indwelling intravenous catheter.
  • the catheter can be operatively connected to a pump, such as an infusion pump, to facilitate flow of the fluids into the host and a desired rate.
  • a pump such as an infusion pump
  • an infusion pump can pump saline into the host at a rate of 1 cc per minute, or at higher or lower rates.
  • the rate of infusion can be changed (increased or decreased).
  • an infusion can be temporarily stopped, to permit injection of pain medication into the IV system, followed by increasing the infusion rate (e.g., for 5 minutes) to rapidly deliver the pain medication to the host's circulatory system.
  • the catheter is configured as an arterial catheter (e.g., configured to be inserted into an arterial line or as part of an arterial line).
  • an arterial catheter is inserted in the wrist (radial artery), armpit (axillary artery), groin (femoral artery), or foot (pedal artery).
  • arterial catheters provide access to the host's blood stream (arterial side) for removal of blood samples and/or application of test devices, such as but not limited to a pressure transducer (for measuring blood pressure automatically), however, arterial catheters can also be used for delivery of fluids or medications.
  • a catheter is inserted into an arterial line and the sensor inserted into the catheter (e.g., functionally coupled) as described elsewhere herein.
  • Saline filled non-compressible tubing is then coupled to the sensor, followed by a pressure transducer.
  • An automatic flushing system e.g., saline
  • Electronics are generally operatively coupled to the pressure transducer for calculating and displaying a variety of parameters including blood pressure.
  • Other medical devices can also be connected to the arterial catheter, to measure various blood components, such as but not limited to O 2 , CO 2 , PCO 2 , PO 2 , potassium, sodium, pH, lactate, urea, bilirubin, creatinine, hematocrit, various minerals, various metabolites, and the like.
  • a blood pressure measurement system is inserted into the host and can be used as is known in the art.
  • the analyte sensor e.g., glucose sensor
  • the pre-inserted catheter e.g., already in-dwelling catheter
  • the pressure transducer is temporarily disabled by disconnecting from the pre-inserted catheter.
  • a cap covers the protective slotted sheath and can be removed so as to enable the sensor to be grasped at the fluid coupler.
  • the sheath which is generally more rigid than the sensor but less flexible than a needle, is then threaded through the pre-inserted catheter so as to extend beyond the catheter into the blood stream (e.g., by about 0.001 inches to about 1 inches).
  • the sheath is then removed by sliding the sensor through a small outlet hole and/or slot in the sheath.
  • the sensor remains within the pre-inserted catheter and the fluid coupler, which supports the distal portion of the sensor, is coupled to the catheter itself.
  • Saline filled non-compressible tubing is then coupled to the second side (e.g., back end) of the fluid coupler.
  • the sensor electronics are then operatively connected (e.g., wired or wirelessly) to the sensor to initiate sensor function.
  • a portion of the sensor system can be configured to allow removal of blood samples from the host's blood stream (e.g., artery or vein).
  • Sample removal can be done using any systems and methods known in the art, for example, as is practiced for removing a blood sample from an arterial catheter (e.g., and arterial line).
  • any tubing or equipment coupled to the second side of the fluid coupler is disconnected.
  • a syringe is then be coupled to the second side and blood removed via the catheter by pulling back on the syringe plunger.
  • saline can be flushed through the fluid coupler and catheter.
  • the fluid coupler can be configured with a side valve, to allow coupling of a syringe, for removal of blood samples or delivery of fluids, such as medications, without disconnecting attached tubing of equipment, and the like.
  • a valve or diaphragm for access to the system by a syringe, can be coupled into the tubing at a short distance from the fluid coupler.
  • the sensor is integrally formed on the arterial catheter, such as the embodiment shown in FIGS. 2A-2B , and tubing can be disconnected from the connector, a syringe operably associated with the connector, and blood removed with the syringe. After blood collection, the syringe is removed and the tubing reconnected to the connector.
  • the analyte sensor can be functionally coupled to an extracorporeal blood flow device.
  • a variety of devices exist for testing various blood properties/analytes at the bedside such as but not limited to the blood gas and chemistry devices manufactured by Via Medical, Austin, Tex., USA. These devices generally withdraw a blood sample from the host, test the blood sample, and then return it to the host.
  • Such a device can be connected in series to the arterial catheter, with the sensor in-between, and using systems and methods known in the art.
  • a sensor such as the embodiment shown in FIGS.
  • the extracorporeal blood flow device is connected to the second side of the fluid coupler.
  • the sensor is integrally formed on the arterial catheter, such as the embodiment shown in FIGS. 2A-2F , and the extracorporeal blood flow device is functionally connected to the connector 218 .
  • Other devices such as but not limited to dialysis machines, heart-lung bypass machines or blood collection bags, or other vascular access devices, can be functionally coupled to the analyte sensor.
  • the analyte sensor system of the preferred embodiments can be designed with a variety of alternative configurations.
  • the sensor is connected to a fluid connection device.
  • the fluid connection device in these embodiments can be any standard fluid connection device known in the art, such as a fluid coupler, or a fluid coupler custom manufactured to preferred specifications.
  • the fluid coupler is configured to couple to an existing catheter or cannula (as described with reference to FIGS. 1A-1E ).
  • the catheter (or cannula) is typically inserted into a vascular access device and/or into a hospital host during a hospital stay.
  • the catheter can be inserted into an arterial line (e.g., for removing blood samples or for measuring blood pressure using a pressure transducer) or a venous line (e.g., for intravenous delivery of drugs and other fluids).
  • the catheter is inserted into the host's blood vessel, for example, and maintained there for a period of time during the host's hospital stay, such as part of the stay or during the entire stay (e.g., perioperatively).
  • another vascular access device e.g., other than a catheter
  • the sensor system of the preferred embodiments can be inserted into a vascular access device (e.g., rather than the vascular system directly).
  • vascular access devices include but are not limited to, catheters, shunts, automated blood withdrawal devices and the like.
  • the system 10 is configured such that the sensor is inserted into a vascular access device, such as but not limited to a catheter 12 (e.g., a catheter that has been inserted into the host's blood stream prior to sensor insertion).
  • a catheter 12 e.g., a catheter that has been inserted into the host's blood stream prior to sensor insertion.
  • catheters are small, flexible tubes (e.g., soft catheter) but they can also be larger, rigid tubes.
  • Catheters are inserted into a host's body cavity, vessel, or duct to provide access for fluid removal or insertion, or for access to medical equipment.
  • Catheters can also be inserted into extracorporeal devices, such as but not limed to an arterio-venous shunt for the transfer of blood from an artery to a vein.
  • Some catheters are used to direct access to the circulatory system (e.g., venous or arterial catheters, Swan Gantz catheters) to allow removal of blood samples, the infusion of fluids (e.g., saline, medications, blood or total parenteral feeding) or access by medical devices (e.g., stents, extracorporeal blood chemistry analysis devices, invasive blood pressure monitors, etc.).
  • fluids e.g., saline, medications, blood or total parenteral feeding
  • medical devices e.g., stents, extracorporeal blood chemistry analysis devices, invasive blood pressure monitors, etc.
  • the senor is designed to include a protective cap, as illustrated in FIGS. 1A-1E .
  • FIG. 1A and 1B illustrates the catheter (the catheter cap having been removed prior to insertion), well known to those skilled in the art, which can be inserted into the host's blood vessel using standard methods.
  • the sensor 14 is configured for measurement of an analyte (e.g., glucose) in the host's body, and is in fluid connection within the catheter lumen, which is in fluid connection with the fluid coupler 20 of the sensor.
  • the first side 20 a of the fluid coupler 20 of the sensor is designed to couple to the catheter, e.g., by screwing or snapping thereon, and can also couple (on its second side 20 b ) with other medical devices.
  • One advantage of the fluid coupler is that it provides for a small amount of bleed back, to prevent air bubbles in the host's blood stream.
  • the exemplary sensor system 10 of FIG. 1A and 1B further includes a slotted protective sheath 26 that supports and protects the sensor during sensor insertion, for example, the sheath increases the sensor visibility (e.g., the sensor is so thin that it can be difficult for some people to see without the protective sheath) and provides for ease of sliding the sensor into the catheter.
  • the slotted protective sheath is configured to fit within the fluid coupler and houses the sensor during insertion of the sensor into the catheter (e.g., an indwelling catheter within the host's blood flow).
  • the protective sheath is substantially more rigid than the sensor and at the same time substantially more flexible that a standard syringe needle, however other designs are possible.
  • a slot 30 is provided with an optional outlet hole 30 a, which is described in more detail with reference to FIG. 1C , and a hub 28 .
  • the user e.g., health care professional
  • the user can withdraw the protective sheath after coupling the fluid coupler to the catheter.
  • a cap Prior to insertion of the sensor, a cap is provided, to cover the protective sheath, for example, to keep the sheath and sensor sterile, and to prevent damage to the components during shipping and/or handling.
  • the sensor system is configured with a potentiostat and/or sensor electronics that are operatively coupled to the sensor.
  • a portion of the sensor electronics such as the potentiostat, can be disposed directly on the fluid coupler.
  • some or all of the sensor electronics can be disposed remotely from the fluid coupler (e.g., on the bedside or on a stand) and can be functionally coupled (e.g., wired or wireless), as is generally known to those skilled in the art.
  • FIGS. 1 C 1 and 1 C 2 are cross-sectional views (not to scale) of the fluid coupler, including a protective sheath 26 , a sensor 14 , and a cap 32 (cap to be removed prior to insertion) in one embodiment.
  • the protective sheath 26 extends through the fluid coupler and houses the sensor, for sensor insertion into a catheter.
  • the protective sheath includes an optional outlet hole 30 a, through which the sensor extends and a slot 30 along a length of the protective sheath that communicates with the outlet hole and enables the protective sheath to be removed after the sensor has been inserted into the host's body.
  • the protective sheath includes a hub 28 for ease of handling.
  • the glucose sensor is utilized in combination with another medical device (e.g., a medical device or access port that is already coupled to, applied to, or connected to the host) in a hospital or similar clinical setting.
  • a catheter can be inserted into the host's vein or artery, wherein the catheter can is connected to additional medical equipment.
  • the catheter is placed in the host to provide quick access to the host's circulatory system (in the event of a need arising) and is simply capped.
  • a dialysis machine can be connected to the host's circulatory system.
  • a central line can be connected to the host, for insertion of medical equipment at the heart (e.g., the medical equipment reaches the heart through the vascular system, from a peripheral location such as a leg or arm pit).
  • the access port is opened.
  • the cap is removed and the sensor inserted into the catheter.
  • the back end of the sensor system can be capped or attached to additional medical equipment (e.g., saline drip, blood pressure transducer, dialysis machine, blood chemistry analysis device, etc.).
  • additional medical equipment e.g., saline drip, blood pressure transducer, dialysis machine, blood chemistry analysis device, etc.
  • medical equipment e.g., saline drip, blood pressure transducer, dialysis machine, blood chemistry analysis device, etc.
  • the medical equipment is disconnected from the catheter, the sensor inserted into (and coupled to) the catheter and then the medical equipment reconnected (e.g., coupled to the back end of the sensor system).
  • the senor is inserted directly into the host's circulatory system without a catheter or other medical device.
  • the sheath covering the sensor is relatively rigid and supports the sensor during insertion. After the sensor has been inserted into the host's vein or artery, the supportive sheath is removed, leaving the exposed sensor in the host's vein or artery.
  • the sensor is inserted into a vascular access device (e.g., with or without a catheter) and the sheath removed, to leave the sensor in the host's vein or artery (e.g., through the vascular access device).
  • the cap 32 over the protective sheath is removed as the health care professional holds the glucose sensor by the fluid coupler 20 .
  • the protective sheath 26 which is generally more rigid than the sensor but more flexible than a needle, is then threaded through the catheter so as to extend beyond the catheter into the blood flow (e.g., by about 0.010 inches to about 1 inches).
  • the protective sheath is then removed by sliding the sensor through the (optional) outlet hole 30 a and slotted portion 30 of the sheath (e.g., by withdrawing the protective sheath by pulling the hub 28 ).
  • the sensor remains within the catheter; and the fluid coupler 20 , which holds the sensor 14 , is coupled to the catheter itself (via its connector 18 ).
  • the sensor electronics e.g., adjacent to the fluid coupler or otherwise coupled to the fluid coupler
  • the sensor electronics are then operatively connected (e.g., wired or wirelessly) to the sensor for proper sensor function as is known in the art.
  • the catheter 12 includes a plurality of perforations (e.g., holes) that allow the host's fluid (e.g., blood) to flow through the lumen 12 a of the catheter.
  • the fluid flowing through the catheter can make contact with a sensor 14 inserted therein.
  • the sensor does not protrude out of the catheter's tip 12 b and the host's blood flowing through the perforated catheter's lumen contacts the sensor's electroactive surfaces.
  • the catheter 12 includes at least a first lumen and a second lumen.
  • the sensor 14 is configured for insertion into the catheter's first lumen.
  • the second lumen can be used for infusions into the host's circulatory system or sample removal without disturbing the sensor within the first lumen.
  • FIGS. 2A-2F are schematic views of a sensor integrally formed (integrally incorporated) onto a surface of a catheter, in some exemplary embodiments.
  • the sensor can be integrally formed on an exterior surface 232 of the catheter.
  • the sensor can be integrally formed on an interior surface of the catheter (e.g., on a lumenal surface).
  • the sensor can be integrally formed on the sensor's tip (e.g., as indicated by 214 a ).
  • the sensor can be integrally incorporated with the catheter, for example by bonding a sensor of the type described in FIGS. 3A to 3C into an inner or outer surface of the catheter.
  • the sensor system is provided with a cap that covers the catheter and in vivo portion of the integral sensor.
  • a needle or trochar that runs the length of the catheter supports the device during insertion into the host's blood stream.
  • medical caregiver holds the device by the fluid connector 218 and removes the cap to expose the in vivo portion of the device (e.g., the catheter).
  • the caregiver inserts the in vivo portion of the device into one of the host's veins or arteries (depending upon whether the catheter is an intravenous catheter or an arterial catheter). After insertion, the needle is withdrawn from the device.
  • the device is then capped or connected to other medical equipment (e.g., saline bag, pressure transducer, blood collection bag, total parenteral feeding, dialysis equipment, automated blood chemistry equipment, etc.).
  • other medical equipment e.g., saline bag, pressure transducer, blood collection bag, total parenteral feeding, dialysis equipment, automated blood chemistry equipment, etc.
  • the sensor-integrated catheter can be in communication (e.g., fluid communication) with the host's vascular system through a vascular access device.
  • a glucose sensor system includes a sensing mechanism substantially similar to that described in U.S. Publication 2006-0020187, which is incorporated herein by reference in its entirety; for example, with platinum working electrode and silver reference electrode coiled there around.
  • the reference electrode can be located remote from the working electrode so as not to be inserted into the host, and can be located, for example, within the fluid coupler, thereby allowing a smaller footprint in the portion of the sensor adapted for insertion into the body (e.g., blood stream); for example, without a coiled or otherwise configured reference electrode proximal to the working electrode.
  • a platinum working electrode is discussed, a variety of known working electrode materials can be utilized (e.g., Platinum-Iridium or Iridium).
  • the reference electrode can be located away from the working electrode (e.g., the electroactive portion) at any location and with any configuration so as to maintain bodily and/or in fluid communication therewith as is appreciated by one skilled in the art.
  • the sensor tip 14 a includes an enlarged, atraumatic area, for example a dull or bulbous portion about two times the diameter of the sensor or larger.
  • the enlarged portion is created by heating, welding, crushing or bonding a substantially rounded structure onto the tip of the sensor (e.g., polymer or metal).
  • the tip of the sensor is heated (e.g., arc welded or flash-butt resistance welded) to cause the tip to enlarge (e.g., by melting).
  • the enlarged portion can be of any atraumatic shape, such as but not limited to oval, round, cone-shaped, cylindrical, teardrop, etc.
  • an atraumatic or enlarged area enables enhanced stability of a small diameter sensor in the blood flow and ensures that the sensor remains within the blood flow (e.g., to avoid piercing a vessel wall and/or becoming inserted subluminally.)
  • a second working electrode can be provided on the sensor for measuring baseline, and thereby subtracting the baseline from the first working electrode to obtain a glucose-only signal, as disclosed in copending U.S. Publication No. US-2005-0143635-A1 and co-pending U.S. patent application Ser. No. ______ filed on even date herewith and entitled “DUAL ELECTRODE SYSTEM FOR A CONTINUOUS ANALYTE SENSOR,” herein incorporated by reference in its entirety.
  • some embodiments of the analyte sensor system include a catheter 212 adapted for inserting into a host in a hospital or clinical setting, wherein the analyte sensor 214 is built integrally with the catheter 212 .
  • a glucose sensor can be integrally formed on the catheter itself.
  • FIGS. 2A-2B illustrate one embodiment, wherein the catheter 212 is configured both for insertion into a host, and can be configured to couple to other medical devices on its ex vivo end. However, coupling to other medical devices is not necessary.
  • the catheter includes a connector 218 configured for connection to tubing or other medical devices, as described herein. The embodiment shown in FIGS.
  • 2A-2B includes two or three electrodes 240 on the outer surface of the in vivo portion of the catheter 212 .
  • the catheter is perforated (as described elsewhere herein) and at least one electrode is disposed within the lumen (not shown) of the perforated catheter.
  • the catheter includes a single lumen. In other embodiment, the catheter includes two or more lumens.
  • At least one working electrode 240 is disposed on the exterior surface of the in vivo portion of the catheter.
  • the at least one working electrode can be disposed on an interior surface of the catheter, the tip of the catheter, extend from the catheter, and the like.
  • the preferred embodiments can be designed with any number of electrodes, including one or more counter electrodes, one or more reference electrodes, and/or one or more auxiliary working electrodes.
  • the electrodes can be of relatively larger or smaller surface area, depending upon their uses.
  • a sensor includes a working electrode and a reference electrode that has a larger surface area (relative to the surface area of the working electrode) on the surface of the catheter.
  • a sensor in another example, includes a working electrode, a counter electrode, and a reference electrode sized to have an increased surface area as compared to the working and/or counter electrode.
  • the reference electrode is disposed at a location remote from the working electrode, such as within the connector (e.g., coiled within the connector). In some embodiments, the reference electrode is located on the host's body (e.g., in body contact).
  • the electrodes 240 can be deposited on the catheter using any suitable techniques known in the art, for example, thick or thin film deposition techniques.
  • the electrodes can be formed of any advantageous electrode materials known in the art (e.g., platinum, platinum-iridium, palladium, graphite, gold, carbon, silver, silver-silver chloride, conductive polymer, alloys, combinations thereof, and the like).
  • one or more of the electrodes is formed from an electrically conductive material (e.g., wire or foil comprising platinum, platinum-iridium, palladium, graphite, gold, carbon, silver, silver-silver chloride, conductive polymer, alloys, combinations thereof, and the like) applied to the exterior surface of the catheter, such as but not limited twisting, coiling, rolling or adhering.
  • an electrically conductive material e.g., wire or foil comprising platinum, platinum-iridium, palladium, graphite, gold, carbon, silver, silver-silver chloride, conductive polymer, alloys, combinations thereof, and the like
  • the catheter is (wired or wirelessly) connected to sensor electronics (not shown, disposed on the catheter's connector and/or remote from the catheter) so as to electrically connect the electrodes on the catheter with the sensor electronics.
  • sensor electronics not shown, disposed on the catheter's connector and/or remote from the catheter
  • the inserted catheter can be utilized by other medical devices for a variety of functions (e.g., blood pressure monitor, drug delivery, etc).
  • an analyte sensor to be disposed in communication with the host's blood
  • transcutaneous e.g., transdermal
  • wholly implantable analyte sensor devices e.g., the sensor could be integrally formed on the in vivo portion of a subcutaneous device or a wholly implantable device.
  • an enlarged surface area e.g., bulbous end
  • the senor can be configured similarly to the continuous analyte sensors disclosed in co-pending U.S. patent application Ser. No. 11/360,250 filed Feb. 22, 2006 and entitled “ANALYTE SENSOR,” herein incorporated by reference in its entirety.
  • the sensor includes a distal portion 342 , also referred to as the in vivo portion, adapted for insertion into the catheter as described above, and a proximal portion 340 , also referred to as an ex vivo portion, adapted to operably connect to the sensor electronics.
  • the senor includes two or more electrodes: a working electrode 344 and at least one additional electrode, which can function as a counter electrode and/or reference electrode, hereinafter referred to as the reference electrode 346 .
  • a membrane system is preferably deposited over the electrodes, such as described in more detail with reference to FIGS. 3A to 3C , below.
  • FIG. 3B is an expanded cutaway view of a distal portion of the sensor in one embodiment, showing working and reference electrodes.
  • the sensor is formed from a working electrode 344 (e.g., a wire) and a reference electrode 346 helically wound around the working electrode 344 .
  • An insulator 345 is disposed between the working and reference electrodes to provide electrical insulation therebetween. Certain portions of the electrodes are exposed to enable electrochemical reaction thereon, for example, a window 343 can be formed in the insulator to expose a portion of the working electrode 344 for electrochemical reaction.
  • each electrode is formed from a fine wire with a diameter of from about 0.001 inches or less to about 0.010 inches or more, for example, and is formed from, e.g., a plated insulator, a plated wire, or bulk electrically conductive material.
  • a variety of known sensor configurations can be employed with the analyte sensor system of the preferred embodiments, such as U.S. Pat. No. 5,711,861 to Ward et al., U.S. Pat. No. 6,642,015 to Vachon et al., U.S. Pat. No. 6,654,625 to Say et al., U.S. Pat. No.
  • the working electrode comprises a wire formed from a conductive material, such as platinum, platinum-iridium, palladium, graphite, gold, carbon, conductive polymer, alloys, and the like.
  • a conductive material such as platinum, platinum-iridium, palladium, graphite, gold, carbon, conductive polymer, alloys, and the like.
  • the electrodes can by formed by a variety of manufacturing techniques (bulk metal processing, deposition of metal onto a substrate, and the like), it can be advantageous to form the electrodes from plated wire (e.g., platinum on steel wire) or bulk metal (e.g., platinum wire).
  • electrodes formed from bulk metal wire provide superior performance (e.g., in contrast to deposited electrodes), including increased stability of assay, simplified manufacturability, resistance to contamination (e.g., which can be introduced in deposition processes), and improved surface reaction (e.g., due to purity of material) without peeling or delamination.
  • the working electrode is formed of platinum-iridium or iridium wire.
  • platinum-iridium and iridium materials are generally stronger (e.g., more resilient and less likely to fail due to stress or strain fracture or fatigue). It is believed that platinum-iridium and/or iridium materials can facilitate a wire with a smaller diameter to further decrease the maximum diameter (size) of the sensor (e.g., in vivo portion).
  • a smaller sensor diameter both reduces the risk of clot or thrombus formation (or other foreign body response) and allows the use of smaller catheters.
  • the electroactive window 343 of the working electrode 344 is configured to measure the concentration of an analyte.
  • the working electrode measures the hydrogen peroxide produced by an enzyme catalyzed reaction of the analyte being detected and creates a measurable electronic current
  • glucose oxidase produces hydrogen peroxide as a byproduct
  • hydrogen peroxide reacts with the surface of the working electrode producing two protons (2H + ), two electrons (2 e ⁇ ) and one molecule of oxygen (O 2 ), which produces the electronic current being detected.
  • the working electrode 344 is covered with an insulating material 345 , for example, a non-conductive polymer. Dip-coating, spray-coating, vapor-deposition, or other coating or deposition techniques can be used to deposit the insulating material on the working electrode.
  • the insulating material comprises parylene, which can be an advantageous polymer coating for its strength, lubricity, and electrical insulation properties. Generally, parylene is produced by vapor deposition and polymerization of para-xylylene (or its substituted derivatives).
  • the lubricious (e.g., smooth) coating (e.g., parylene) on the sensors of some embodiments contributes to minimal trauma and extended sensor life.
  • any suitable insulating material can be used, for example, fluorinated polymers, polyethyleneterephthalate, polyurethane, polyiride, other nonconducting polymers, and the like. Glass or ceramic materials can also be employed. Other materials suitable for use include surface energy modified coating systems such as are marketed under the trade names AMC18, AMC148, AMC141, and AMC321 by Advanced Materials Components Express of Bellafonte, Pa.
  • the working electrode may not require a coating of insulator.
  • the reference electrode 346 which can function as a reference electrode alone, or as a dual reference and counter electrode, is formed from silver, silver/silver chloride, and the like. In some embodiments, the reference electrode 346 is juxtapositioned and/or twisted with or around the working electrode 344 ; however other configurations are also possible (e.g., coiled within the fluid connector, or an intradermal or on-skin reference electrode). In the illustrated embodiments, the reference electrode 346 is helically wound around the working electrode 344 . The assembly of wires is then optionally coated or adhered together with an insulating material, similar to that described above, so as to provide an insulating attachment.
  • a silver wire is formed onto the sensor as described above, and subsequently chloridized to form silver/silver chloride reference electrode.
  • chloridizing the silver wire as described herein enables the manufacture of a reference electrode with optimal in vivo performance. Namely, by controlling the quantity and amount of chloridization of the silver to form silver/silver chloride, improved break-in time, stability of the reference electrode, and extended life has been shown with some embodiments. Additionally, use of silver chloride as described above allows for relatively inexpensive and simple manufacture of the reference electrode.
  • a portion of the coated assembly structure can be stripped or otherwise removed, for example, by hand, excimer lasing, chemical etching, laser ablation, grit-blasting (e.g., with sodium bicarbonate or other suitable grit), and the like, to expose the electroactive surfaces.
  • grit blasting is implemented to expose the electroactive surfaces, preferably utilizing a grit material that is sufficiently hard to ablate the polymer material, while being sufficiently soft so as to minimize or avoid damage to the underlying metal electrode (e.g., a platinum electrode).
  • sodium bicarbonate is an advantageous grit-material because it is sufficiently hard to ablate, e.g., a parylene coating, without damaging, e.g., an underlying platinum conductor.
  • One additional advantage of sodium bicarbonate blasting includes its polishing action on the metal as it strips the polymer layer, thereby eliminating a cleaning step that might otherwise be necessary.
  • a radial window 343 is formed through the insulating material 345 to expose a circumferential electroactive surface of the working electrode. Additionally, sections of electroactive surface of the reference electrode are exposed. For example, the sections of electroactive surface can be masked during deposition of an outer insulating layer or etched after deposition of an outer insulating layer.
  • cellular attack or migration of cells to the sensor can cause reduced sensitivity and/or function of the device, particularly after the first day of implantation.
  • the exposed electroactive surface is distributed circumferentially about the sensor (e.g., as in a radial window)
  • the available surface area for reaction can be sufficiently distributed so as to minimize the effect of local cellular invasion of the sensor on the sensor signal.
  • a tangential exposed electroactive window can be formed, for example, by stripping only one side of the coated assembly structure.
  • the window can be provided at the tip of the coated assembly structure such that the electroactive surfaces are exposed at the tip of the sensor.
  • Other methods and configurations for exposing electroactive surfaces can also be employed.
  • the working electrode has a diameter of from about 0.001 inches or less to about 0.010 inches or more, preferably from about 0.002 inches to about 0.008 inches, and more preferably from about 0.004 inches to about 0.005 inches.
  • the length of the window can be from about 0.1 mm (about 0.004 inches) or less to about 2 mm (about 0.078 inches) or more, and preferably from about 0.25 mm (about 0.01 inches) to about 0.375 mm (about 0.015 inches).
  • the exposed surface area of the working electrode is preferably from about 0.000013 in 2 (0.0000839 cm 2 ) or less to about 0.0025 in 2 (0.016129 cm 2 ) or more (assuming a diameter of from about 0.001 inches to about 0.010 inches and a length of from about 0.004 inches to about 0.078 inches).
  • the preferred exposed surface area of the working electrode is selected to produce an analyte signal with a current in the picoAmp range, such as is described in more detail elsewhere herein.
  • a current in the picoAmp range can be dependent upon a variety of factors, for example the electronic circuitry design (e.g., sample rate, current draw, A/D converter bit resolution, etc.), the membrane system (e.g., permeability of the analyte through the membrane system), and the exposed surface area of the working electrode.
  • the exposed electroactive working electrode surface area can be selected to have a value greater than or less than the above-described ranges taking into consideration alterations in the membrane system and/or electronic circuitry.
  • it can be advantageous to minimize the surface area of the working electrode while maximizing the diffusivity of glucose in order to optimize the signal-to-noise ratio while maintaining sensor performance in both high and low glucose concentration ranges.
  • the exposed surface area of the working (and/or other) electrode can be increased by altering the cross-section of the electrode itself.
  • the cross-section of the working electrode can be defined by a cross, star, cloverleaf, ribbed, dimpled, ridged, irregular, or other non-circular configuration; thus, for any predetermined length of electrode, a specific increased surface area can be achieved (as compared to the area achieved by a circular cross-section).
  • Increasing the surface area of the working electrode can be advantageous in providing an increased signal responsive to the analyte concentration, which in turn can be helpful in improving the signal-to-noise ratio, for example.
  • additional electrodes can be included within the assembly, for example, a three-electrode system (working, reference, and counter electrodes) and/or an additional working electrode (e.g., an electrode which can be used to generate oxygen, which is configured as a baseline subtracting electrode, or which is configured for measuring additional analytes).
  • a three-electrode system working, reference, and counter electrodes
  • an additional working electrode e.g., an electrode which can be used to generate oxygen, which is configured as a baseline subtracting electrode, or which is configured for measuring additional analytes.
  • U.S. Publication No. US-2005-0161346-A1 U.S. Publication No. US-2005-0143635-A1
  • co-pending U.S. patent application Ser. No. ______ filed on even date herewith and entitled “DUAL ELECTRODE SYSTEM FOR A CONTINUOUS ANALYTE SENSOR” describe some systems and methods for implementing and using additional working, counter, and/or reference electrodes.
  • the two working electrodes are juxtapositioned (e.g., extend parallel to each other), around which the reference electrode is disposed (e.g., helically wound).
  • the working electrodes can be formed in a double-, triple-, quad-, etc. helix configuration along the length of the sensor (for example, surrounding a reference electrode, insulated rod, or other support structure).
  • the resulting electrode system can be configured with an appropriate membrane system, wherein the first working electrode is configured to measure a first signal comprising glucose and baseline (e.g., background noise) and the additional working electrode is configured to measure a baseline signal consisting of baseline only (e.g., configured to be substantially similar to the first working electrode without an enzyme disposed thereon).
  • the baseline signal can be subtracted from the first signal to produce a glucose-only signal that is substantially not subject to fluctuations in the baseline and/or interfering species on the signal.
  • the working electrode comprises a tube with a reference electrode disposed or coiled inside, including an insulator therebetween.
  • the reference electrode comprises a tube with a working electrode disposed or coiled inside, including an insulator therebetween.
  • a polymer (e.g., insulating) rod is provided, wherein the electrodes are deposited (e.g., electro-plated) thereon.
  • a metallic (e.g., steel) rod is provided, coated with an insulating material, onto which the working and reference electrodes are deposited.
  • one or more working electrodes are helically wound around a reference electrode.
  • the electrodes and membrane systems of the preferred embodiments are coaxially formed, namely, the electrodes and/or membrane system all share the same central axis.
  • a coaxial design of the sensor enables a symmetrical design without a preferred bend radius.
  • the coaxial design of the preferred embodiments do not have a preferred bend radius and therefore are not subject to regular bending about a particular plane (which can cause fatigue failures and the like).
  • non-coaxial sensors can be implemented with the sensor system of the preferred embodiments.
  • the coaxial sensor design of the preferred embodiments enables the diameter of the connecting end of the sensor (proximal portion) to be substantially the same as that of the sensing end (distal portion) such that the protective slotted sheath is able to insert the sensor into the catheter and subsequently slide back over the sensor and release the sensor from the protective slotted sheath, without complex multi-component designs.
  • the two wires of the sensor are held apart and configured for insertion into the catheter in proximal but separate locations.
  • the separation of the working and reference electrodes in such an embodiment can provide additional electrochemical stability with simplified manufacture and electrical connectivity.
  • One skilled in the art will appreciate that a variety of electrode configurations can be implemented with the preferred embodiments.
  • the reference electrode can be separated from the working electrode, and coiled within a portion of the fluid connector, in some embodiments.
  • the reference electrode is coiled within the fluid connector and adjacent to its first side.
  • the reference electrode is coiled within the fluid connector and adjacent to its second side.
  • the reference electrode is in contact with fluid, such as saline from a saline drip that is flowing into the host, or such as blood that is being withdrawn from the host. While not wishing to be bound by theory, this configuration is believed to be advantageous because the sensor is thinner, allowing the use of smaller catheters and/or a reduced likelihood to thrombus production.
  • the reference electrode 346 can be disposed farther away from the electroactive portion of the working electrode 343 (e.g., closer to the fluid connector).
  • the reference electrode is located proximal to or within the fluid coupler, such as but not limited to coiled about the catheter adjacent to the fluid coupler or coiled within the fluid coupler and in contact with fluid flowing through the fluid coupler, such as saline. These configurations can also minimize at least a portion of the sensor diameter and thereby allow the use of smaller catheters and reduce the risk of clots.
  • the senor can be configured with additional working electrodes as described in U.S. Publication No. US-2005-0143635-A1, U.S. Pat. No. 7,081,195, and U.S. patent application Ser. No. ______ filed on even date herewith and entitled “DUAL ELECTRODE SYSTEM FOR CONTINUOUS ANALYTE SENSOR,” herein incorporated by reference in their entirety.
  • the auxiliary working electrode comprises a wire formed from a conductive material, such as described with reference to the glucose-measuring working electrode above.
  • the reference electrode which can function as a reference electrode alone, or as a dual reference and counter electrode, is formed from silver, Silver/Silver chloride, and the like.
  • the electrodes are juxtapositioned and/or twisted with or around each other; however other configurations are also possible.
  • the auxiliary working electrode and reference electrode can be helically wound around the glucose-measuring working electrode.
  • the auxiliary working electrode and reference electrode can be formed as a double helix around a length of the glucose-measuring working electrode.
  • the assembly of wires can then be optionally coated together with an insulating material, similar to that described above, in order to provide an insulating attachment. Some portion of the coated assembly structure is then stripped, for example using an excimer laser, chemical etching, and the like, to expose the necessary electroactive surfaces.
  • additional electrodes can be included within the assembly, for example, a three-electrode system (including separate reference and counter electrodes) as is appreciated by one skilled in the art.
  • the senor is configured as a dual-electrode system.
  • a first electrode functions as a hydrogen peroxide sensor including a membrane system containing glucose-oxidase disposed thereon, which operates as described herein.
  • a second electrode is a hydrogen peroxide sensor that is configured similar to the first electrode, but with a modified membrane system (without active enzyme, for example). This second electrode provides a signal composed mostly of the baseline signal, b.
  • U.S. Publication No. US-2005-0143635-A1 describes systems and methods for subtracting the baseline from a sensor signal.
  • the analyte sensor is configured to transmit signals obtained from each electrode separately (e.g., without subtraction of the baseline signal).
  • the receiver can process these signals to determine additional information about the sensor and/or analyte concentration. For example, by comparing the signals from the first and second electrodes, changes in baseline and/or sensitivity can be detected and/or measured and used to update calibration (e.g., without the use of a reference analyte value). In one such example, by monitoring the corresponding first and second signals over time, an amount of signal contributed by baseline can be measured. In another such example, by comparing fluctuations in the correlating signals over time, changes in sensitivity can be detected and/or measured.
  • the reference electrode can be disposed remotely from the working electrode.
  • the reference electrode remains within the fluid flow, but is disposed within the fluid coupler.
  • the reference electrode can be coiled within the fluid coupler such that it is contact with saline flowing into the host, but it is not in physical contact with the host's blood (except when blood is withdrawn from the catheter).
  • the reference electrode is removed from fluid flow, but still maintains bodily fluid contact.
  • the reference electrode can be wired to an adhesive patch that is adhered to the host, such that the reference electrode is in contact with the host's skin.
  • the reference electrode can be external from the system, such as but not limited to in contact with the exterior of the ex vivo portion of the system, in fluid or electrical contact with a connected saline drip or other medical device, or in bodily contact, such as is generally done with EKG electrical contacts. While not wishing to be bound by theory, it is believed to locating the reference electrode remotely from the working electrode permits manufacture of a smaller sensor footprint (e.g., diameter) that will have relatively less affect on the host's blood flow, such as less thrombosis, than a sensor having a relatively larger footprint (e.g., wherein both the working electrode and the reference electrode are adjacent to each other and within the blood path).
  • a smaller sensor footprint e.g., diameter
  • in vivo portion of the sensor (e.g., the tip 14 a) has an enlarged area (e.g., a bulbous, nail head-shaped, football-shaped, cone-shaped, cylindrical, etc. portion) as compared a substantial portion of the sensor (e.g., diameter of the in vivo portion of the sensor).
  • the sensor tip can be made bulbous by any convenient systems and methods known in the art, such as but not limited to arc welding, crimping, smashing, welding, molding, heating, and plasma arc welding. While not wishing to be bound by theory, it is believed that an enlarged sensor tip (e.g., bulbous) will prevent vessel piercing as the sensor is pushed forward into the vessel.
  • the sensor of the preferred embodiments is designed with a minimally invasive architecture so as to minimize reactions or effects on the blood flow (or on the sensor in the blood flow). Accordingly, the sensor designs described herein, consider minimization of dimensions and arrangement of the electrodes and other components of the sensor system, particularly the in vivo portion of the sensor (or any portion of the sensor in fluid contact with the blood flow).
  • a substantial portion of the in vivo portion of the sensor is designed with at least one dimension less than about 0.015, 0.012, 0.010, 0.008, 0.006, 0.005, 0.004 inches.
  • a substantial portion of the sensor that is in fluid contact with the blood flow is designed with at least one dimension less than about 0.015, 0.012, 0.010, 0.008, 0.006, 0.005, 0.004, 0.003, 0.002, 0.001 inches.
  • a sensor such as described in more detail with reference to FIGS.
  • 1A to 1C is formed from a 0.004-inch conductive wire (e.g., platinum) for a diameter of about 0.004 inches along a substantial portion of the sensor (e.g., in vivo portion or fluid contact portion).
  • a sensor such as described in more detail with reference to FIGS. 1A to 1C is formed from a 0.004 inch conductive wire and vapor deposited with an insulator material for a diameter of about 0.005 inches along a substantial portion of the sensor (e.g., in vivo portion or fluid contact portion), after which a desired electroactive surface area can be exposed.
  • the reference electrode can be located remote from the working electrode (e.g., formed from the conductive wire).
  • FIG. 3C is a cross section of the sensor shown in FIG. 3B , taken at line C-C.
  • a membrane system (see FIG. 3C ) is deposited over the electroactive surfaces of the sensor and includes a plurality of domains or layers, such as described in more detail below, with reference to FIGS. 3B and 3C .
  • the membrane system can be deposited on the exposed electroactive surfaces using known thin film techniques (for example, spraying, electro-depositing, dipping, and the like).
  • each domain is deposited by dipping the sensor into a solution and drawing out the sensor at a speed that provides the appropriate domain thickness.
  • the membrane system can be disposed over (deposited on) the electroactive surfaces using methods appreciated by one skilled in the art.
  • the membrane system includes a plurality of domains, for example, an electrode domain 347 , an interference domain 348 , an enzyme domain 349 (for example, including glucose oxidase), and a resistance domain 350 , as shown in FIG. 3C , and can include a high oxygen solubility domain, and/or a bioprotective domain (not shown), such as is described in more detail in U.S. Publication No. US-2005-0245799-A1, and such as is described in more detail below.
  • the membrane system can be deposited on the exposed electroactive surfaces using known thin film techniques (for example, vapor deposition, spraying, electro-depositing, dipping, and the like).
  • vapor deposition processes e.g., physical and/or chemical vapor deposition processes
  • other vapor deposition processes can be useful for providing one or more of the insulating and/or membrane layers, including ultrasonic vapor deposition, electrostatic deposition, evaporative deposition, deposition by sputtering, pulsed laser deposition, high velocity oxygen fuel deposition, thermal evaporator deposition, electron beam evaporator deposition, deposition by reactive sputtering molecular beam epitaxy, atmospheric pressure chemical vapor deposition (CVD), atomic layer CVD, hot wire CVD, low-pressure CVD, microwave plasma-assisted CVD, plasma-enhanced CVD, rapid thermal CVD, remote plasma-enhanced CVD, and ultra-high vacuum CVD, for example.
  • the membrane system can be disposed over (or deposited on) the electroactive surfaces using any known method, as will be appreciated by one skilled in the art.
  • one or more domains of the membrane systems are formed from materials such as described above in connection with the porous layer, such as silicone, polytetrafluoroethylene, polyethylene-co-tetrafluoroethylene, polyolefin, polyester, polycarbonate, biostable polytetrafluoroethylene, homopolymers, copolymers, terpolymers of polyurethanes, polypropylene (PP), polyvinylchloride (PVC), polyvinylidene fluoride (PVDF), polybutylene terephthalate (PBT), polymethylmethacrylate (PMMA), polyether ether ketone (PEEK), polyurethanes, cellulosic polymers, polysulfones and block copolymers thereof including, for example, di-block, tri-block, alternating, random and graft copolymers.
  • silicone polytetrafluoroethylene, polyethylene-co-tetrafluoroethylene, polyolefin, polyester, polycarbonate,
  • the membrane system comprises an electrode domain.
  • the electrode domain 347 is provided to ensure that an electrochemical reaction occurs between the electroactive surfaces of the working electrode and the reference electrode, and thus the electrode domain 347 is preferably situated more proximal to the electroactive surfaces than the interference and/or enzyme domain.
  • the electrode domain includes a coating that maintains a layer of water at the electrochemically reactive surfaces of the sensor.
  • the electrode domain is present to provide an environment between the surfaces of the working electrode and the reference electrode, which facilitates an electrochemical reaction between the electrodes.
  • a humectant in a binder material can be employed as an electrode domain; this allows for the full transport of ions in the aqueous environment.
  • the electrode domain can also assist in stabilizing the operation of the sensor by accelerating electrode start-up and drifting problems caused by inadequate electrolyte.
  • the material that forms the electrode domain can also provide an environment that protects against pH-mediated damage that can result from the formation of a large pH gradient due to the electrochemical activity of the electrodes.
  • the electrode domain 347 includes a flexible, water-swellable, hydrogel film having a “dry film” thickness of from about 0.05 micron or less to about 20 microns or more, more preferably from about 0.05, 0.1, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 1, 1.5, 2, 2.5, 3, or 3.5 microns to about 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 19.5 microns, and more preferably still from about 2, 2.5 or 3 microns to about 3.5, 4, 4.5, or 5 microns.
  • “Dry film” thickness refers to the thickness of a cured film cast from a coating formulation by standard coating techniques.
  • the electrode domain 347 is formed of a curable mixture of a urethane polymer and a hydrophilic polymer.
  • Particularly preferred coatings are formed of a polyurethane polymer having carboxylate or hydroxyl functional groups and non-ionic hydrophilic polyether segments, wherein the polyurethane polymer is crosslinked with a water-soluble carbodiimide (e.g., 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide (EDC)) in the presence of polyvinylpyrnolidone and cured at a moderate temperature of about 50° C.
  • a water-soluble carbodiimide e.g., 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide (EDC)
  • the electrode domain 347 is formed from a hydrophilic polymer such as polyvinylpyrrolidone (PVP).
  • PVP polyvinylpyrrolidone
  • An electrode domain formed from PVP has been shown to reduce break-in time of analyte sensors; for example, a glucose sensor utilizing a cellulosic-based interference domain such as described in more detail below.
  • the electrode domain is deposited by vapor deposition, spray coating, dip coating, or other thin film techniques on the electroactive surfaces of the sensor.
  • the electrode domain is formed by dip-coating the electroactive surfaces in an electrode layer solution and curing the domain for a time of from about 15 minutes to about 30 minutes at a temperature of from about 40° C. to about 55° C. (and can be accomplished under vacuum (e.g., 20 to 30 mmHg)).
  • a preferred insertion rate of from about 1 to about 3 inches per minute into the electrode layer solution, with a preferred dwell time of from about 0.5 to about 2 minutes in the electrode layer solution, and a preferred withdrawal rate of from about 0.25 to about 2 inches per minute from the electrode layer solution provide a functional coating.
  • values outside of those set forth above can be acceptable or even desirable in certain embodiments, for example, depending upon solution viscosity and solution surface tension, as is appreciated by one skilled in the art.
  • the electroactive surfaces of the electrode system are dip-coated one time (one layer) and cured at 50° C. under vacuum for 20 minutes.
  • an independent electrode domain 347 is described herein, in some embodiments sufficient hydrophilicity can be provided in the interference domain and/or enzyme domain (the domain adjacent to the electroactive surfaces) so as to provide for the full transport of ions in the aqueous environment (e.g. without a distinct electrode domain). In these embodiments, an electrode domain is not necessary.
  • Interferents are molecules or other species that are reduced or oxidized at the electrochemically reactive surfaces of the sensor, either directly or via an electron transfer agent, to produce a false positive analyte signal.
  • an interference domain 348 is provided that substantially restricts, resists, or blocks the flow of one or more interfering species.
  • Some known interfering species for a glucose sensor include acetaminophen, ascorbic acid, bilirubin, cholesterol, creatinine, dopamine, ephedrine, ibuprofen, L-dopa, methyl dopa, salicylate, tetracycline, tolazamide, tolbutamide, triglycerides, and uric acid.
  • the interference domain of the preferred embodiments is less permeable to one or more of the interfering species than to the analyte, e.g., glucose.
  • the interference domain 348 is formed from one or more cellulosic derivatives.
  • cellulosic derivatives include polymers such as cellulose acetate, cellulose acetate butyrate, 2-hydroxyethyl cellulose, cellulose acetate phthalate, cellulose acetate propionate, cellulose acetate trimellitate, and the like.
  • the interference domain 348 is formed from cellulose acetate butyrate.
  • a casting solution or dispersion of cellulose acetate butyrate at a weight percent of about 15% to about 25%, preferably from about 15%, 16%, 17%, 18%, 19% to about 20%, 21%, 22%, 23%, 24% or 25%, and more preferably about 18% is preferred.
  • the casting solution includes a solvent or solvent system, for example an acetone:ethanol solvent system. Higher or lower concentrations can be preferred in certain embodiments.
  • a plurality of layers of cellulose acetate butyrate can be advantageously combined to form the interference domain in some embodiments, for example, three layers can be employed.
  • cellulose acetate butyrate components with different molecular weights in a single solution, or to deposit multiple layers of cellulose acetate butyrate from different solutions comprising cellulose acetate butyrate of different molecular weights, different concentrations, and/or different chemistries (e.g., functional groups). It can also be desirable to include additional substances in the casting solutions or dispersions, e.g., functionalizing agents, crosslinking agents, other polymeric substances, substances capable of modifying the hydrophilicity/hydrophobicity of the resulting layer, and the like.
  • additional substances in the casting solutions or dispersions e.g., functionalizing agents, crosslinking agents, other polymeric substances, substances capable of modifying the hydrophilicity/hydrophobicity of the resulting layer, and the like.
  • the interference domain 348 is formed from cellulose acetate.
  • Cellulose acetate with a molecular weight of about 30,000 daltons or less to about 100,000 daltons or more, preferably from about 35,000, 40,000, or 45,000 daltons to about 55,000, 60,000, 65,000, 70,000, 75,000, 80,000, 85,000, 90,000, or 95,000 daltons, and more preferably about 50,000 daltons is preferred.
  • a casting solution or dispersion of cellulose acetate at a weight percent of about 3% to about 10%, preferably from about 3.5%, 4.0%, 4.5%, 5.0%, 5.5%, 6.0%, or 6.5% to about 7.5%, 8.0%, 8.5%, 9.0%, or 9.5%, and more preferably about 8% is preferred.
  • higher or lower molecular weights and/or cellulose acetate weight percentages can be preferred. It can be desirable to employ a mixture of cellulose acetates with molecular weights in a single solution, or to deposit multiple layers of cellulose acetate from different solutions comprising cellulose acetates of different molecular weights, different concentrations, or different chemistries (e.g., functional groups). It can also be desirable to include additional substances in the casting solutions or dispersions such as described in more detail above.
  • Layer(s) prepared from combinations of cellulose acetate and cellulose acetate butyrate, or combinations of layer(s) of cellulose acetate and layer(s) of cellulose acetate butyrate can also be employed to form the interference domain 348 .
  • additional polymers such as Nafione
  • cellulosic derivatives can be used in combination with cellulosic derivatives to provide equivalent and/or enhanced function of the interference domain 348 .
  • a 5 wt % Nafion® casting solution or dispersion can be used in combination with a 8 wt % cellulose acetate casting solution or dispersion, e.g., by dip coating at least one layer of cellulose acetate and subsequently dip coating at least one layer Nafion® onto a needle-type sensor such as described with reference to the preferred embodiments. Any number of coatings or layers formed in any order may be suitable for forming the interference domain of the preferred embodiments.
  • more than one cellulosic derivative can be used to form the interference domain 348 of the preferred embodiments.
  • the formation of the interference domain on a surface utilizes a solvent or solvent system in order to solvate the cellulosic derivative (or other polymer) prior to film formation thereon.
  • acetone and ethanol are used as solvents for cellulose acetate; however one skilled in the art appreciates the numerous solvents that are suitable for use with cellulosic derivatives (and other polymers).
  • the preferred relative amounts of solvent can be dependent upon the cellulosic derivative (or other polymer) used, its molecular weight, its method of deposition, its desired thickness, and the like.
  • a percent solute of from about 1% to about 25% is preferably used to form the interference domain solution so as to yield an interference domain having the desired properties.
  • the cellulosic derivative (or other polymer) used, its molecular weight, method of deposition, and desired thickness can be adjusted, depending upon one or more other of the parameters, and can be varied accordingly as is appreciated by one skilled in the art.
  • the interference domain 348 includes a thin, hydrophobic membrane that is non-swellable and restricts diffusion of low molecular weight species.
  • the interference domain 348 is permeable to relatively low molecular weight substances, such as hydrogen peroxide, but restricts the passage of higher molecular weight substances, including glucose and ascorbic acid.
  • the interference domain 348 is deposited directly onto the electroactive surfaces of the sensor for a domain thickness of from about 0.05 micron or less to about 20 microns or more, more preferably from about 0.05, 0.1, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 1, 1.5, 2, 2.5, 3, or 3.5 microns to about 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 19.5 microns, and more preferably still from about 1, 1.5 or 2 microns to about 2.5 or 3 microns.
  • Thicker membranes can also be desirable in certain embodiments, but thinner membranes are generally preferred because they can have a lower impact on the rate of diffusion of hydrogen peroxide from the enzyme membrane to the electrodes.
  • the membrane systems of the preferred embodiments can be formed and/or deposited on the exposed electroactive surfaces (e.g., one or more of the working and reference electrodes) using known thin film techniques (for example, casting, spray coating, drawing down, electro-depositing, dip coating, and the like), however casting or other known application techniques can also be utilized.
  • the interference domain is deposited by vapor deposition, spray coating, or dip coating.
  • the interference domain is formed by dip coating the sensor into an interference domain solution using an insertion rate of from about 20 inches/min to about 60 inches/min, preferably 40 inches/min, a dwell time of from about 0 minute to about 5 seconds, preferably 0 seconds, and a withdrawal rate of from about 20 inches/minute to about 60 inches/minute, preferably about 40 inches/minute, and curing (drying) the domain from about 1 minute to about 30 minutes, preferably from about 3 minutes to about 15 minutes (and can be accomplished at room temperature or under vacuum (e.g., 20 to 30 mmHg)).
  • a 3-minute cure (i.e., dry) time is preferred between each layer applied.
  • a 15 minute cure (i.e., dry) time is preferred between each layer applied.
  • the dip process can be repeated at least one time and up to 10 times or more.
  • the preferred number of repeated dip processes depends upon the cellulosic derivative(s) used, their concentration, conditions during deposition (e.g., dipping) and the desired thickness (e.g., sufficient thickness to provide functional blocking of (or resistance to) certain interferents), and the like.
  • 1 to 3 microns may be preferred for the interference domain thickness; however, values outside of these can be acceptable or even desirable in certain embodiments, for example, depending upon viscosity and surface tension, as is appreciated by one skilled in the art.
  • an interference domain is formed from three layers of cellulose acetate butyrate.
  • an interference domain is formed from 10 layers of cellulose acetate.
  • the interference domain can be formed using any known method and combination of cellulose acetate and cellulose acetate butyrate, as will be appreciated by one skilled in the art.
  • the electroactive surface can be cleaned prior to application of the interference domain 348 .
  • the interference domain 348 of the preferred embodiments can be useful as a bioprotective or biocompatible domain, namely, a domain that interfaces with host tissue when implanted in an animal (e.g., a human) due to its stability and biocompatibility.
  • the membrane system further includes an enzyme domain 349 disposed more distally from the electroactive surfaces than the interference domain 348 ; however other configurations can be desirable.
  • the enzyme domain provides an enzyme to catalyze the reaction of the analyte and its co-reactant, as described in more detail below.
  • the enzyme domain includes glucose oxidase; however other oxidases, for example, galactose oxidase or uricase oxidase, can also be used.
  • the sensor's response is preferably limited by neither enzyme activity nor co-reactant concentration. Because enzymes, including glucose oxidase, are subject to deactivation as a function of time even in ambient conditions, this behavior is compensated for in forming the enzyme domain.
  • the enzyme domain is constructed of aqueous dispersions of colloidal polyurethane polymers including the enzyme.
  • the enzyme domain is constructed from an oxygen enhancing material, for example, silicone, or fluorocarbon, in order to provide a supply of excess oxygen during transient ischemia.
  • the enzyme is immobilized within the domain. See, e.g., U.S. Publication No. US-2005-0054909-A1.
  • the enzyme domain is deposited onto the interference domain for a domain thickness of from about 0.05 micron or less to about 20 microns or more, more preferably from about 0.05, 0.1, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 1, 1.5, 2, 2.5, 3, or 3.5 microns to about 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 19.5 microns, and more preferably still from about 2, 2.5 or 3 microns to about 3.5, 4, 4.5, or 5 microns.
  • the enzyme domain can be deposited directly onto the electroactive surfaces.
  • the enzyme domain is deposited by spray or dip coating.
  • the enzyme domain is formed by dip coating the interference domain coated sensor into an enzyme domain solution and curing the domain for from about 15 to about 30 minutes at a temperature of from about 40° C. to about 55° C. (and can be accomplished under vacuum (e.g., 20 to 30 mmHg)).
  • a preferred insertion rate of from about 0.25 inch per minute to about 3 inches per minute, with a preferred dwell time of from about 0.5 minutes to about 2 minutes, and a preferred withdrawal rate of from about 0.25 inch per minute to about 2 inches per minute provides a functional coating.
  • the enzyme domain is formed by dip coating two times (namely, forming two layers) in an enzyme domain solution and curing at 50° C. under vacuum for 20 minutes.
  • the enzyme domain can be formed by dip coating and/or spray coating one or more layers at a predetermined concentration of the coating solution, insertion rate, dwell time, withdrawal rate, and/or desired thickness.
  • the membrane system includes a resistance domain 350 disposed more distal from the electroactive surfaces than the enzyme domain.
  • a resistance domain 350 disposed more distal from the electroactive surfaces than the enzyme domain.
  • an immobilized enzyme-based glucose sensor employing oxygen as co-reactant is preferably supplied with oxygen in non-rate-limiting excess in order for the sensor to respond linearly to changes in glucose concentration, while not responding to changes in oxygen concentration. Specifically, when a glucose-monitoring reaction is oxygen limited, linearity is not achieved above minimal concentrations of glucose.
  • a linear response to glucose levels can be obtained only for glucose concentrations of up to about 40 mg/dL. However, in a clinical setting, a linear response to glucose levels is desirable up to at least about 400 mg/dL.
  • the resistance domain includes a semipermeable membrane that controls the flux of oxygen and glucose to the underlying enzyme domain, preferably rendering oxygen in a non-rate-limiting excess.
  • the resistance domain exhibits an oxygen to glucose permeability ratio of from about 50:1 or less to about 400:1 or more, preferably about 200:1.
  • one-dimensional reactant diffusion is adequate to provide excess oxygen at all reasonable glucose and oxygen concentrations found in the subcutaneous matrix (See Rhodes et al., Anal. Chem., 66:1520-1529 (1994)).
  • a lower ratio of oxygen-to-glucose can be sufficient to provide excess oxygen by using a high oxygen solubility domain (for example, a silicone or fluorocarbon-based material or domain) to enhance the supply/transport of oxygen to the enzyme domain. If more oxygen is supplied to the enzyme, then more glucose can also be supplied to the enzyme without creating an oxygen rate-limiting excess.
  • the resistance domain is formed from a silicone composition, such as is described in U.S. Publication No. US-2005-0090607-A1.
  • the resistance domain includes a polyurethane membrane with both hydrophilic and hydrophobic regions to control the diffusion of glucose and oxygen to an analyte sensor, the membrane being fabricated easily and reproducibly from commercially available materials.
  • a suitable hydrophobic polymer component is a polyurethane, or polyetherurethaneurea.
  • Polyurethane is a polymer produced by the condensation reaction of a diisocyanate and a difunctional hydroxyl-containing material.
  • a polyurethaneurea is a polymer produced by the condensation reaction of a diisocyanate and a difunctional amine-containing material.
  • Preferred diisocyanates include aliphatic diisocyanates containing from about 4 to about 8 methylene units.
  • Diisocyanates containing cycloaliphatic moieties can also be useful in the preparation of the polymer and copolymer components of the membranes of preferred embodiments.
  • the material that forms the basis of the hydrophobic matrix of the resistance domain can be any of those known in the art as appropriate for use as membranes in sensor devices and as having sufficient permeability to allow relevant compounds to pass through it, for example, to allow an oxygen molecule to pass through the membrane from the sample under examination in order to reach the active enzyme or electrochemical electrodes.
  • non-polyurethane type membranes examples include vinyl polymers, polyethers, polyesters, polyamides, inorganic polymers such as polysiloxanes and polycarbosiloxanes, natural polymers such as cellulosic and protein based materials, and mixtures or combinations thereof.
  • the hydrophilic polymer component is polyethylene oxide.
  • one useful hydrophobic-hydrophilic copolymer component is a polyurethane polymer that includes about 20% hydrophilic polyethylene oxide.
  • the polyethylene oxide portions of the copolymer are thermodynamically driven to separate from the hydrophobic portions of the copolymer and the hydrophobic polymer component.
  • the 20% polyethylene oxide-based soft segment portion of the copolymer used to form the final blend affects the water pick-up and subsequent glucose permeability of the membrane.
  • the resistance domain is formed from a silicone polymer modified to allow analyte (e.g., glucose) transport.
  • analyte e.g., glucose
  • the resistance domain is formed from a silicone polymer/hydrophobic-hydrophilic polymer blend.
  • the hydrophobic-hydrophilic polymer for use in the blend may be any suitable hydrophobic-hydrophilic polymer, including but not limited to components such as polyvinylpyrrolidone (PVP), polyhydroxyethyl methacrylate, polyvinylalcohol, polyacrylic acid, polyethers such as polyethylene glycol or polypropylene oxide, and copolymers thereof, including, for example, di-block, tri-block, alternating, random, comb, star, dendritic, and graft copolymers (block copolymers are discussed in U.S. Pat. Nos.
  • the hydrophobic-hydrophilic polymer is a copolymer of poly(ethylene oxide) (PEO) and poly(propylene oxide) (PPO). Suitable such polymers include, but are not limited to, PEO-PPO diblock copolymers, PPO-PEO-PPO triblock copolymers, PEO-PPO-PEO triblock copolymers, alternating block copolymers of PEO-PPO, random copolymers of ethylene oxide and propylene oxide, and blends thereof. In some embodiments, the copolymers may be optionally substituted with hydroxy substituents.
  • PEO and PPO copolymers include the PLURONIC® brand of polymers available from BASF®. In one embodiment, PLURONIC® F-127 is used. Other PLURONIC® polymers include PPO-PEO-PPO triblock copolymers (e.g., PLURONIC® R products). Other suitable commercial polymers include, but are not limited to, SYNPERONICS® products available from UNIQEMA®. Co-pending U.S. patent application Ser. No.
  • the resistance domain is deposited onto the enzyme domain to yield a domain thickness of from about 0.05 microns or less to about 20 microns or more, more preferably from about 0.05, 0.1, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 1, 1.5, 2, 2.5, 3, or 3.5 microns to about 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 19.5 microns, and more preferably still from about 2, 2.5 or 3 microns to about 3.5, 4, 4.5, or 5 microns.
  • the resistance domain is deposited onto the enzyme domain by vapor deposition, spray coating, or dip coating.
  • spray coating is the preferred deposition technique. The spraying process atomizes and mists the solution, and therefore most or all of the solvent is evaporated prior to the coating material settling on the underlying domain, thereby minimizing contact of the solvent with the enzyme.
  • physical vapor deposition e.g., ultrasonic vapor deposition
  • the vapor deposition apparatus and process include an ultrasonic nozzle that produces a mist of micro-droplets in a vacuum chamber.
  • the micro-droplets move turbulently within the vacuum chamber, isotropically impacting and adhering to the surface of the substrate.
  • vapor deposition as described above can be implemented to provide high production throughput of membrane deposition processes (e.g., at least about 20 to about 200 or more electrodes per chamber), greater consistency of the membrane on each sensor, and increased uniformity of sensor performance, for example, as described below.
  • depositing the resistance domain includes formation of a membrane system that substantially blocks or resists ascorbate (a known electrochemical interferant in hydrogen peroxide-measuring glucose sensors). While not wishing to be bound by theory, it is believed that during the process of depositing the resistance domain as described in the preferred embodiments, a structural morphology is formed that is characterized in that ascorbate does not substantially permeate therethrough.
  • ascorbate a known electrochemical interferant in hydrogen peroxide-measuring glucose sensors
  • the resistance domain is deposited on the enzyme domain by spray coating a solution of from about 1 wt. % to about 5 wt. % polymer and from about 95 wt. % to about 99 wt. % solvent.
  • a solution of resistance domain material including a solvent
  • Tetrahydrofuran (THF) is one solvent that minimally or negligibly affects the enzyme of the enzyme domain upon spraying.
  • Other solvents can also be suitable for use, as is appreciated by one skilled in the art.
  • spraying the resistance domain material and rotating the sensor at least one time by 180° can typically provide adequate coverage by the resistance domain.
  • Spraying the resistance domain material and rotating the sensor at least two times by 120° provides even greater coverage (one layer of 360° coverage), thereby ensuring resistivity to glucose, such as is described in more detail above.
  • the resistance domain is spray coated and subsequently cured for a time of from about 15 minutes to about 90 minutes at a temperature of from about 40° C. to about 60° C. (and can be accomplished under vacuum (e.g., from 20 to 30 mmHg)).
  • a cure time of up to about 90 minutes or more can be advantageous to ensure complete drying of the resistance domain.
  • the resistance domain is formed by spray coating at least six layers (namely, rotating the sensor seventeen times by 1200 for at least six layers of 360° coverage) and curing at 50° C. under vacuum for 60 minutes.
  • the resistance domain can be formed by dip coating or spray coating any layer or plurality of layers, depending upon the concentration of the solution, insertion rate, dwell time, withdrawal rate, and/or the desired thickness of the resulting film. Additionally, curing in a convention oven can also be employed.
  • a variable frequency microwave oven can be used to cure the membrane domains/layers.
  • microwave ovens directly excite the rotational mode of solvents. Consequently, microwave ovens cure coatings from the inside out rather than from the outside in as with conventional convection ovens. This direct rotational mode excitation is responsible for the typically observed “fast” curing within a microwave oven.
  • VFM Variable Frequency Microwave
  • VFM curing can increase the rate and completeness of solvent evaporation from a liquid membrane solution applied to a sensor, as compared to the rate and completeness of solvent evaporation observed for curing in conventional convection ovens.
  • VFM is can be used together with convection oven curing to further accelerate cure time.
  • conventional microwave ovens e.g., fixed frequency microwave ovens
  • the preferred embodiments further include an additional treatment step, which can be performed directly after the formation of the interference domain and/or some time after the formation of the entire membrane system (or anytime in between).
  • the additional treatment step is performed during (or in combination with) sterilization of the sensor.
  • the membrane system (or interference domain) is treated by exposure to ionizing radiation, for example, electron beam radiation, UV radiation, X-ray radiation, gamma radiation, and the like.
  • ionizing radiation for example, electron beam radiation, UV radiation, X-ray radiation, gamma radiation, and the like.
  • the membrane can be exposed to visible light when suitable photoinitiators are incorporated into the interference domain. While not wishing to be bound by theory, it is believed that exposing the interference domain to ionizing radiation substantially crosslinks the interference domain and thereby creates a tighter, less permeable network than an interference domain that has not been exposed to ionizing radiation.
  • the membrane system (or interference domain) is crosslinked by forming free radicals, which may include the use of ionizing radiation, thermal initiators, chemical initiators, photoinitiators (e.g., UV and visible light), and the like.
  • Any suitable initiator or any suitable initiator system can be employed, for example, ⁇ -hydroxyketone, ⁇ -aminoketone, ammonium persulfate (APS), redox systems such as APS/bisulfite, or potassium permanganate.
  • Suitable thermal initiators include but are not limited to potassium persulfate, ammonium persulfate, sodium persulfate, and mixtures thereof.
  • a preferred exposure time is from about 6 k or 12 kGy to about 25 or 50 kGy, more preferably about 25 kGy.
  • the exposure is sufficient for substantially crosslinking the interference domain to form free radicals, but does not destroy or significantly break down the membrane or does not significantly damage the underlying electroactive surfaces.
  • UV radiation is employed to treat the membrane
  • UV rays from about 200 nm to about 400 nm are preferred; however values outside of this range can be employed in certain embodiments, dependent upon the cellulosic derivative and/or other polymer used.
  • one or more additional domains can be provided adjacent to the interference domain for preventing delamination that may be caused by the crosslinking treatment.
  • These additional domains can be “tie layers” (i.e., film layers that enhance adhesion of the interference domain to other domains of the membrane system).
  • a membrane system is formed that includes the following domains: resistance domain, enzyme domain, electrode domain, and cellulosic-based interference domain, wherein the electrode domain is configured to ensure adhesion between the enzyme domain and the interference domain.
  • UV radiation of greater than about 290 nm is preferred.
  • photoinitiator from about 0.01 to about 1 wt % photoinitiator is preferred weight-to-weight with a preselected cellulosic polymer (e.g., cellulose acetate); however values outside of this range can be desirable dependent upon the cellulosic polymer selected.
  • a preselected cellulosic polymer e.g., cellulose acetate
  • sterilization of the transcutaneous sensor can be completed after final assembly, utilizing methods such as electron beam radiation, gamma radiation, glutaraldehyde treatment, and the like.
  • the sensor can be sterilized prior to or after packaging.
  • one or more sensors can be sterilized using variable frequency microwave chamber(s), which can increase the speed and reduce the cost of the sterilization process.
  • one or more sensors can be sterilized using ethylene oxide (EtO) gas sterilization, for example, by treating with 100% ethylene oxide, which can be used when the sensor electronics are not detachably connected to the sensor and/or when the sensor electronics must undergo a sterilization process.
  • one or more packaged sets of transcutaneous sensors e.g., 1, 2, 3, 4, or 5 sensors or more are sterilized simultaneously.
  • the therapeutic agent is an anticoagulant.
  • anticoagulant as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a substance the prevents coagulation (e.g., minimizes, reduces, or stops clotting of blood).
  • an anticoagulant is included in the analyte sensor system to prevent coagulation within or on the sensor (e.g., within or on the catheter or within or on the sensor).
  • Suitable anticoagulants for incorporation into the sensor system include, but are not limited to, vitamin K antagonists (e.g., Acenocoumarol, Clorindione, Dicumarol (Dicoumarol), Diphenadione, Ethyl biscoumacetate, Phenprocoumon, Phenindione, Tioclomarol, or Warfarin), heparin group anticoagulants (e.g., Platelet aggregation inhibitors: Antithrombin III, Bemiparin, Dalteparin, Danaparoid, Enoxaparin, Heparin, Nadroparin, Parnaparin, Reviparin, Sulodexide, Tinzaparin), other platelet aggregation inhibitors (e.g., Abciximab, Acetylsalicylic acid
  • heparin is incorporated into the analyte sensor system.
  • heparin is coated on the catheter and/or sensor by dipping or spraying. While not wishing to be bound by theory, it is believed that heparin coated on the catheter and/or sensor prevents aggregation and clotting of blood on the analyte sensor system, thereby preventing thromboembolization (e.g., prevention of blood flow by the thrombus or clot) and/or subsequent complications.
  • the membrane system of the preferred embodiments preferably include a bioactive agent, which is incorporated into at least a portion of the membrane system, or which is incorporated into the device and adapted to diffuse through the membrane.
  • the bioactive agent is incorporated into the membrane of the preferred embodiments.
  • the bioactive agent is incorporated at the time of manufacture of the membrane system.
  • the bioactive agent can be blended prior to curing the membrane system, or subsequent to membrane system manufacture, for example, by coating, imbibing, solvent-casting, or sorption of the bioactive agent into the membrane system.
  • the bioactive agent is preferably incorporated into the membrane system, in some embodiments the bioactive agent can be administered concurrently with, prior to, or after insertion of the device intravascularly, for example, by oral administration, or locally, for example, by subcutaneous injection near the implantation site.
  • a combination of bioactive agent incorporated in the membrane system and bioactive agent administration locally and/or systemically can be preferred in certain embodiments.
  • a bioactive agent can be incorporated into the membrane system, and/or incorporated into the device and adapted to diffuse therefrom, in order to modify the tissue response of the host to the membrane.
  • the bioactive agent is incorporated only into a portion of the membrane system adjacent to the sensing region of the device, over the entire surface of the device except over the sensing region, or any combination thereof, which can be helpful in controlling different mechanisms and/or stages of thrombus formation.
  • the bioactive agent is incorporated into the device proximal to the membrane system, such that the bioactive agent diffuses through the membrane system to the host circulatory system.
  • the bioactive agent can include a carrier matrix, wherein the matrix includes one or more of collagen, a particulate matrix, a resorbable or non-resorbable matrix, a controlled-release matrix, and/or a gel.
  • the carrier matrix includes a reservoir, wherein a bioactive agent is encapsulated within a microcapsule.
  • the carrier matrix can include a system in which a bioactive agent is physically entrapped within a polymer network.
  • the bioactive agent is cross-linked with the membrane system, while in others the bioactive agent is sorbed into the membrane system, for example, by adsorption, absorption, or imbibing.
  • the bioactive agent can be deposited in or on the membrane system, for example, by coating, filling, or solvent casting.
  • ionic and nonionic surfactants ionic and nonionic surfactants, detergents, micelles, emulsifiers, demulsifiers, stabilizers, aqueous and oleaginous carriers, solvents, preservatives, antioxidants, or buffering agents are used to incorporate the bioactive agent into the membrane system.
  • the bioactive agent can be incorporated into a polymer using techniques such as described above, and the polymer can be used to form the membrane system, coatings on the membrane system, portions of the membrane system, and/or any portion of the sensor system.
  • the membrane system can be manufactured using techniques known in the art.
  • the bioactive agent can be sorbed into the membrane system, for example, by soaking the membrane system for a length of time (for example, from about an hour or less to about a week or more, preferably from about 4, 8, 12, 16, or 20 hours to about 1, 2, 3, 4, 5, or 7 days).
  • the bioactive agent can be blended into uncured polymer prior to forming the membrane system.
  • the membrane system is then cured and the bioactive agent thereby cross-linked and/or encapsulated within the polymer that forms the membrane system.
  • microspheres are used to encapsulate the bioactive agent.
  • the microspheres can be formed of biodegradable polymers, most preferably synthetic polymers or natural polymers such as proteins and polysaccharides.
  • polymer is used to refer to both to synthetic polymers and proteins.
  • bioactive agents can be incorporated in (1) the polymer matrix forming the microspheres, (2) microparticle(s) surrounded by the polymer which forms the microspheres, (3) a polymer core within a protein microsphere, (4) a polymer coating around a polymer microsphere, (5) mixed in with microspheres aggregated into a larger form, or (6) a combination thereof.
  • Bioactive agents can be incorporated as particulates or by co-dissolving the factors with the polymer.
  • Stabilizers can be incorporated by addition of the stabilizers to the factor solution prior to formation of the microspheres.
  • the bioactive agent can be incorporated into a hydrogel and coated or otherwise deposited in or on the membrane system.
  • Some hydrogels suitable for use in the preferred embodiments include cross-linked, hydrophilic, three-dimensional polymer networks that are highly permeable to the bioactive agent and are triggered to release the bioactive agent based on a stimulus.
  • the bioactive agent can be incorporated into the membrane system by solvent casting, wherein a solution including dissolved bioactive agent is disposed on the surface of the membrane system, after which the solvent is removed to form a coating on the membrane surface.
  • the bioactive agent can be compounded into a plug of material, which is placed within the device, such as is described in U.S. Pat. Nos. 4,506,680 and 5,282,844, which are incorporated herein by reference in their entirety.
  • bioactive agents of the preferred embodiments can be optimized for short- and/or long-term release.
  • the bioactive agents of the preferred embodiments are designed to aid or overcome factors associated with short-term effects (e.g., acute inflammation and/or thrombosis) of sensor insertion.
  • the bioactive agents of the preferred embodiments are designed to aid or overcome factors associated with long-term effects, for example, chronic inflammation or build-up of fibrotic tissue and/or plaque material.
  • the bioactive agents of the preferred embodiments combine short- and long-term release to exploit the benefits of both.
  • controlled,” “sustained,” or “extended” release of the factors can be continuous or discontinuous, linear or non-linear. This can be accomplished using one or more types of polymer compositions, drug loadings, selections of excipients or degradation enhancers, or other modifications, administered alone, in combination or sequentially to produce the desired effect.
  • Short-term release of the bioactive agent in the preferred embodiments generally refers to release over a period of from about a few minutes or hours to about 2, 3, 4, 5, 6, or 7 days or more.
  • the amount of loading of the bioactive agent into the membrane system can depend upon several factors.
  • the bioactive agent dosage and duration can vary with the intended use of the membrane system, for example, the intended length of use of the device and the like; differences among patients in the effective dose of bioactive agent; location and methods of loading the bioactive agent; and release rates associated with bioactive agents and optionally their carrier matrix. Therefore, one skilled in the art will appreciate the variability in the levels of loading the bioactive agent, for the reasons described above.
  • the preferred level of loading of the bioactive agent into the membrane system can vary depending upon the nature of the bioactive agent.
  • the level of loading of the bioactive agent is preferably sufficiently high such that a biological effect (e.g., thrombosis prevention) is observed. Above this threshold, bioactive agent can be loaded into the membrane system so as to imbibe up to 100% of the solid portions, cover all accessible surfaces of the membrane, and/or fill up to 100% of the accessible cavity space.
  • the level of loading (based on the weight of bioactive agent(s), membrane system, and other substances present) is from about 1 ppm or less to about 1000 ppm or more, preferably from about 2, 3, 4, or 5 ppm up to about 10, 25, 50, 75, 100, 200, 300, 400, 500, 600, 700, 800, or 900 ppm.
  • the level of loading can be 1 wt. % or less up to about 50 wt. % or more, preferably from about 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, or 20 wt. % up to about 25, 30, 35, 40, or 45 wt. %.
  • the gel concentration can be optimized, for example, loaded with one or more test loadings of the bioactive agent. It is generally preferred that the gel contain from about 0.1 or less to about 50 wt. % or more of the bioactive agent(s), preferably from about 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, or 0.9 wt. % to about 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, or 45 wt. % or more bioactive agent(s), more preferably from about 1, 2, or 3 wt. % to about 4 or 5 wt. % of the bioactive agent(s). Substances that are not bioactive can also be incorporated into the matrix.
  • the bioactive agent can be released by diffusion through aqueous filled channels generated in the dosage form by the dissolution of the agent or by voids created by the removal of the polymer solvent or a pore forming agent during the original micro-encapsulation.
  • release can be enhanced due to the degradation of the encapsulating polymer. With time, the polymer erodes and generates increased porosity and microstructure within the device. This creates additional pathways for release of the bioactive agent.
  • the senor is designed to be bioinert, e.g., by the use of bioinert materials.
  • Bioinert materials do not substantially cause any response from the host. As a result, cells can live adjacent to the material but do not form a bond with it.
  • Bioinert materials include but are not limited to alumina, zirconia, titanium oxide or other bioinert materials generally used in the “catheter/catheterization” art. While not wishing to be bound by theory, it is believed that inclusion of a bioinert material in or on the sensor can reduce attachment of blood cells or proteins to the sensor, thrombosis or other host reactions to the sensor.
  • the analyte sensor system has electronics, also referred to as a “computer system” that can include hardware, firmware, and/or software that enable measurement and processing of data associated with analyte levels in the host.
  • the electronics include a potentiostat, a power source for providing power to the sensor, and other components useful for signal processing.
  • the electronics include an RF module for transmitting data from sensor electronics to a receiver remote from the sensor.
  • the sensor electronics are wired to a receiver, which records the data and optionally transmits the data to a remote location, such as but not limited to a nurse's station, for tracking the host's progress and to alarm the staff is a hypoglycemic episode occurs.
  • Various components of the electronics of the sensor system can be disposed on or proximal to the analyte sensor, such as but not limited to disposed on the fluid coupler 20 of the system, such as the embodiment shown in FIG. 1A .
  • the sensor is integrally formed on the catheter (e.g., see FIG. 2A ) and the electronics are disposed on or proximal to the connector 218 .
  • only a portion of the electronics e.g., the potentiostat
  • the device e.g., proximal to the sensor
  • the remaining electronics are disposed remotely from the device, such as on a stand or by the bedside.
  • a portion of the electronics can be disposed in a central location, such as a nurse's station.
  • some or all of the electronics can be in wired or wireless communication with the sensor and/or other portions of the electronics.
  • a potentiostat disposed on the device can be wired to the remaining electronics (e.g., a processor, a recorder, a transmitter, a receiver, etc.), which reside on the bedside.
  • some portion of the electronics is wirelessly connected to another portion of the electronics, such as by infrared (IR) or RF.
  • IR infrared
  • a potentiostat resides on the fluid coupler and is connected to a receiver by RF; accordingly, a battery, RF transmitter, and/or other minimally necessary electronics are provided with the fluid coupler and the receiver includes an RF receiver.
  • the potentiostat is operably connected to the electrode(s) (such as described above), which biases the sensor to enable measurement of a current signal indicative of the analyte concentration in the host (also referred to as the analog portion).
  • the potentiostat includes a resistor that translates the current into voltage.
  • a current to frequency converter is provided that is configured to continuously integrate the measured current, for example, using a charge counting device.
  • the electronics include an A/D converter that digitizes the analog signal into a digital signal, also referred to as “counts” for processing. Accordingly, the resulting raw data stream in counts, also referred to as raw sensor data, is directly related to the current measured by the potentiostat.
  • the electronics include a processor module that includes the central control unit that controls the processing of the sensor system.
  • the processor module includes a microprocessor, however a computer system other than a microprocessor can be used to process data as described herein, for example an ASIC can be used for some or all of the sensor's central processing.
  • the processor typically provides semi-permanent storage of data, for example, storing data such as sensor identifier (ID) and programming to process data streams (for example, programming for data smoothing and/or replacement of signal artifacts such as is described in U.S. Publication No. US-2005-0043598-A1).
  • the processor additionally can be used for the system's cache memory, for example for temporarily storing recent sensor data.
  • the processor module comprises memory storage components such as ROM, RAM, dynamic-RAM, static-RAM, non-static RAM, EEPROM, rewritable ROMs, flash memory, and the like.
  • the processor module comprises a digital filter, for example, an infinite impulse response (IIR) or finite impulse response (FIR) filter, configured to smooth the raw data stream from the A/D converter.
  • digital filters are programmed to filter data sampled at a predetermined time interval (also referred to as a sample rate).
  • time intervals also referred to as a sample rate.
  • the processor module can be programmed to request a digital value from the A/D converter at a predetermined time interval, also referred to as the acquisition time.
  • the values obtained by the processor are advantageously averaged over the acquisition time due the continuity of the current measurement. Accordingly, the acquisition time determines the sample rate of the digital filter.
  • the processor module is configured with a programmable acquisition time, namely, the predetermined time interval for requesting the digital value from the A/D converter is programmable by a user within the digital circuitry of the processor module. An acquisition time of from about 2 seconds to about 512 seconds is preferred; however any acquisition time can be programmed into the processor module.
  • a programmable acquisition time is advantageous in optimizing noise filtration, time lag, and processing/battery power.
  • the processor module is configured to build the data packet for transmission to an outside source, for example, an RF transmission to a receiver.
  • the data packet comprises a plurality of bits that can include a preamble, a unique identifier identifying the electronics unit, the receiver, or both, (e.g., sensor ID code), data (e.g., raw data, filtered data, and/or an integrated value) and/or error detection or correction.
  • the data (transmission) packet has a length of from about 8 bits to about 128 bits, preferably about 48 bits; however, larger or smaller packets can be desirable in certain embodiments.
  • the processor module can be configured to transmit any combination of raw and/or filtered data.
  • the transmission packet contains a fixed preamble, a unique ID of the electronics unit, a single five-minute average (e.g., integrated) sensor data value, and a cyclic redundancy code (CRC).
  • CRC cyclic redundancy code
  • the processor module further comprises a transmitter portion that determines the transmission interval of the sensor data to a receiver, and the like.
  • the transmitter portion which determines the interval of transmission, is configured to be programmable.
  • a coefficient can be chosen (e.g., a number of from about 1 to about 100, or more), wherein the coefficient is multiplied by the acquisition time (or sampling rate), such as described above, to define the transmission interval of the data packet.
  • the transmission interval is programmable from about 2 seconds to about 850 minutes, more preferably from about 30 second to about 5 minutes; however, any transmission interval can be programmable or programmed into the processor module.
  • a variety of alternative systems and methods for providing a programmable transmission interval can also be employed.
  • data transmission can be customized to meet a variety of design criteria (e.g., reduced battery consumption, timeliness of reporting sensor values, etc.)
  • the processor further performs the processing, such as storing data, analyzing data streams, calibrating analyte sensor data, estimating analyte values, comparing estimated analyte values with time corresponding measured analyte values, analyzing a variation of estimated analyte values, downloading data, and controlling the user interface by providing analyte values, prompts, messages, warnings, alarms, and the like.
  • the processor includes hardware and software that performs the processing described herein, for example flash memory provides permanent or semi-permanent storage of data, storing data such as sensor ID, receiver ID, and programming to process data streams (for example, programming for performing estimation and other algorithms described elsewhere herein) and random access memory (RAM) stores the system's cache memory and is helpful in data processing.
  • flash memory provides permanent or semi-permanent storage of data, storing data such as sensor ID, receiver ID, and programming to process data streams (for example, programming for performing estimation and other algorithms described elsewhere herein) and random access memory (RAM) stores the system's cache memory and is helpful in data processing.
  • RAM random access memory
  • some portion of the data processing can be accomplished at another (e.g., remote) processor and can be configured to be in wired or wireless connection therewith.
  • an output module which is integral with and/or operatively connected with the processor, includes programming for generating output based on the data stream received from the sensor system and it's processing incurred in the processor. In some embodiments, output is generated via a user interface.
  • a user interface is provided integral with (e.g., on the patient inserted medical device), proximal to (e.g., a receiver near the medical device including bedside or on a stand), or remote from the sensor electronics (e.g., at a central station such as a nurse's station), wherein the user interface comprises a keyboard, speaker, vibrator, backlight, liquid crystal display (LCD) screen, and one or more buttons.
  • the components that comprise the user interface include controls to allow interaction of the user with the sensor system.
  • the keyboard can allow, for example, input of user information, such as mealtime, exercise, insulin administration, customized therapy recommendations, and reference analyte values.
  • the speaker can produce, for example, audible signals or alerts for conditions such as present and/or estimated hyperglycemic or hypoglycemic conditions.
  • the vibrator can provide, for example, tactile signals or alerts for reasons such as described with reference to the speaker, above.
  • the backlight can be provided, for example, to aid a user in reading the LCD in low light conditions.
  • the LCD can be provided, for example, to provide the user with visual data output, such as is described in U.S. Publication No. US-2005-0203360-A1.
  • the LCD is a touch-activated screen, enabling each selection by a user, for example, from a menu on the screen.
  • the buttons can provide for toggle, menu selection, option selection, mode selection, and reset, for example.
  • a microphone can be provided to allow for voice-activated control.
  • prompts or messages can be displayed on the user interface to convey information to the user, such as reference outlier values, requests for reference analyte values, therapy recommendations, deviation of the measured analyte values from the estimated analyte values, and the like. Additionally, prompts can be displayed to guide the user through calibration or trouble-shooting of the calibration.
  • data output from the output module can provide wired or wireless, one- or two-way communication between the user interface and an external device.
  • the external device can be any device that wherein interfaces or communicates with the user interface.
  • the external device is a computer, and the system is able to download historical data for retrospective analysis by the patient or physician, for example.
  • the external device is a modem or other telecommunications station, and the system is able to send alerts, warnings, emergency messages, and the like, via telecommunication lines to another party, such as a doctor or family member.
  • the external device is an insulin pen, and the system is able to communicate therapy recommendations, such as insulin amount and time to the insulin pen.
  • the external device is an insulin pump, and the system is able to communicate therapy recommendations, such as insulin amount and time to the insulin pump.
  • the external device can include other technology or medical devices, for example pacemakers, implanted analyte sensor patches, other infusion devices, telemetry devices, and the like.
  • the user interface including keyboard, buttons, a microphone (not shown), and optionally the external device, can be configured to allow input of data.
  • Data input can be helpful in obtaining information about the patient (for example, meal time, insulin administration, and the like), receiving instructions from a physician (for example, customized therapy recommendations, targets, and the like), and downloading software updates, for example.
  • Keyboard, buttons, touch-screen, and microphone are all examples of mechanisms by which a user can input data directly into the receiver.
  • a server, personal computer, personal digital assistant, insulin pump, and insulin pen are examples of external devices that can provide useful information to the receiver.
  • Other devices internal or external to the sensor that measure other aspects of a patient's body can be used to provide input helpful in data processing.
  • the user interface can prompt the patient to select an activity most closely related to their present activity, such as medication taken, surgical procedures, and the like, which can be helpful in linking to an individual's physiological patterns, or other data processing.
  • a temperature sensor and/or heart rate monitor can provide information helpful in linking activity, metabolism, and glucose excursions of an individual. While a few examples of data input have been provided here, a variety of information can be input, which can be helpful in data processing.
  • calibration of an analyte sensor can be required, which includes data processing that converts sensor data signal into an estimated analyte measurement that is meaningful to a user.
  • the sensor system has a computer system (e.g., within the electronics) that receives sensor data (e.g., a data stream), including one or more time-spaced sensor data points, measured by the sensor.
  • the sensor data point(s) can be smoothed (filtered) in certain embodiments using a filter, for example, a finite impulse response (FIR) or infinite impulse response (IIR) filter.
  • FIR finite impulse response
  • IIR infinite impulse response
  • the system can receive and store uncalibrated sensor data, however it can be configured to not display any data to the user until initial calibration and, optionally, stabilization of the sensor has been established.
  • the data stream can be evaluated to determine sensor break-in (equilibration of the sensor in vitro or in vivo).
  • the system is configured to receive reference data from a reference analyte monitor, including one or more reference data points, also referred to as calibration information in some embodiments.
  • the monitor can be of any suitable configuration.
  • the reference analyte points can comprise results from a self-monitored blood analyte test (e.g., from a finger stick test), such as those described in U.S. Pat. Nos. 6,045,567; 6,156,051; 6,197,040; 6,284,125; 6,413,410; and 6,733,655.
  • the user can administer a self-monitored blood analyte test to obtain an analyte value (e.g., point) using any suitable analyte sensor, and then enter the numeric analyte value into the computer system.
  • a self-monitored blood analyte test comprises a wired or wireless connection to the computer system so that the user simply initiates a connection between the two devices, and the reference analyte data is passed or downloaded between the self-monitored blood analyte test and the system.
  • the self-monitored analyte test is integral with the receiver so that the user simply provides a blood sample to the receiver, and the receiver runs the analyte test to determine a reference analyte value.
  • the reference data is based on sensor data from another substantially continuous analyte sensor such as described herein, or another type of suitable continuous analyte sensor.
  • the sensors can be employed so that they provide sensor data in discrete or overlapping periods.
  • the sensor data from one continuous sensor can be used to calibrate another continuous sensor, or be used to confirm the validity of a subsequently employed continuous sensor.
  • the sensor system is coupled to a blood analysis device that periodically or intermittently collects a sample of the host's blood (e.g., through the sensor system) and measures the host's glucose concentration.
  • the blood analysis device collects a blood sample from the host about every 30 minutes, every hour, or every few hours (e.g., 2, 3, 4, 5, 6, 8, 9 or 10 hours or longer).
  • the blood analysis device can be activated manually (e.g., by a healthcare worker) to collect and analyze a blood sample from the host.
  • the glucose concentration data generated by the blood analysis device can be used by the sensor system for calibration data.
  • the sensor system can electronically receive (either wired or wirelessly) these calibration data (from the blood analysis device).
  • these calibration data can be entered into the sensor system (e.g., sensor system electronics) by hand (e.g., manually entered by a healthcare worker).
  • the sensor system is provided with one or more calibration solutions (e.g., glucose solutions).
  • the sensor is shipped in a calibration solution (e.g., soaked). The sensor is activated to calibrate itself (using the calibration solution in which it was shipped) before insertion into the host.
  • the sensor is shipped (e.g., soaked or dry) with one or more vials of calibration solution. The sensor can be soaked (e.g., sequentially) in the vial(s) of calibration solution; calibration data points collected and the sensor calibrated using those calibration points, before inserting the sensor into the host.
  • the senor is a glucose sensor, and it is shipped soaking in a sterile 50-mg/dl glucose solution with two accompanying calibration solutions (e.g., 100-mg/dl and 200-mg/dl sterile glucose solutions). Prior to insertion into the host, calibration data points are collected with the sensor in the 50-mg/dl, 100-mg/dl and 200-mg/dl glucose solutions respectively. The sensor system can be calibrated using the collected calibration data points (e.g., using regression as described in more detail elsewhere herein).
  • the sensor is shipped dry (e.g., not soaking in a solution or buffer) with at least one calibration solution, for calibrating the sensor prior to insertion into the host.
  • a hand held glucose monitor e.g., SMBG device described herein
  • a data matching module also referred to as the processor module, matches reference data (e.g., one or more reference analyte data points) with substantially time corresponding sensor data (e.g., one or more sensor data points) to provide one or more matched data pairs.
  • reference data e.g., one or more reference analyte data points
  • sensor data e.g., one or more sensor data points
  • One reference data point can be matched to one time corresponding sensor data point to form a matched data pair.
  • a plurality of reference data points can be averaged (e.g., equally or non-equally weighted average, mean-value, median, and the like) and matched to one time corresponding sensor data point to form a matched data pair, one reference data point can be matched to a plurality of time corresponding sensor data points averaged to form a matched data pair, or a plurality of reference data points can be averaged and matched to a plurality of time corresponding sensor data points averaged to form a matched data pair.
  • a calibration set module forms an initial calibration set from a set of one or more matched data pairs, which are used to determine the relationship between the reference analyte data and the sensor analyte data.
  • the matched data pairs, which make up the initial calibration set can be selected according to predetermined criteria.
  • the criteria for the initial calibration set can be the same as, or different from, the criteria for the updated calibration sets.
  • the number (n) of data pair(s) selected for the initial calibration set is one.
  • n data pairs are selected for the initial calibration set wherein n is a function of the frequency of the received reference data points.
  • two data pairs make up the initial calibration set or six data pairs make up the initial calibration set.
  • a substantially continuous analyte sensor provides reference data
  • numerous data points are used to provide reference data from more than 6 data pairs (e.g., dozens or even hundreds of data pairs).
  • a substantially continuous analyte sensor provides 288 reference data points per day (every five minutes for twenty-four hours), thereby providing an opportunity for a matched data pair 288 times per day, for example. While specific numbers of matched data pairs are referred to in the preferred embodiments, any suitable number of matched data pairs per a given time period can be employed.
  • a conversion function module also referred to as the conversion module or processor module, uses the calibration set to create a conversion function.
  • the conversion function substantially defines the relationship between the reference analyte data and the analyte sensor data.
  • a variety of known methods can be used with the preferred embodiments to create the conversion function from the calibration set.
  • a variety of regression or other conversion schemes can be implemented herein.
  • the senor is a dual-electrode system.
  • a first electrode functions as a hydrogen peroxide sensor including a membrane system containing glucose-oxidase disposed thereon, which operates as described herein.
  • a second electrode is a hydrogen peroxide sensor that is configured similar to the first electrode, but with a modified membrane system (with the enzyme domain removed, for example). This second electrode provides a signal composed mostly of the baseline signal, b.
  • U.S. Publication No. US-2005-0143635-A1 describes systems and methods for subtracting the baseline from a sensor signal.
  • the analyte sensor is configured to transmit signals obtained from each electrode separately (e.g., without subtraction of the baseline signal).
  • the receiver can process these signals to determine additional information about the sensor and/or analyte concentration. For example, by comparing the signals from the first and second electrodes, changes in baseline and/or sensitivity can be detected and/or measured and used to update calibration (e.g., without the use of a reference analyte value). In one such example, by monitoring the corresponding first and second signals over time, an amount of signal contributed by baseline can be measured. In another such example, by comparing fluctuations in the correlating signals over time, changes in sensitivity can be detected and/or measured.
  • prior information e.g., obtained from in vivo or in vitro tests
  • prior information can be provided to guide or validate the baseline (b) and/or sensitivity (m) determined from the regression analysis.
  • boundaries can be set for the regression line that defines the conversion function such that working sensors are calibrated accurately and easily (with two points), and non-working sensors are prevented from being calibrated. If the boundaries are drawn too tightly, a working sensor may not enter into calibration. Likewise, if the boundaries are drawn too loosely, the scheme can result in inaccurate calibration or can permit non-working sensors to enter into calibration. For example, subsequent to performing regression, the resulting slope and/or baseline are tested to determine whether they fall within a predetermined acceptable threshold (boundaries). These predetermined acceptable boundaries can be obtained from in vivo or in vitro tests (e.g., by a retrospective analysis of sensor sensitivities and/or baselines collected from a set of sensors/patients, assuming that the set is representative of future data).
  • the senor system does not require initial and/or update calibration by the host; in these alternative embodiments, also referred to as “zero-point calibration” embodiments, use of the sensor system without requiring a reference analyte measurement for initial and/or update calibration is enabled.
  • the systems and methods of the preferred embodiments provide for stable and repeatable sensor manufacture, particularly when tightly controlled manufacturing processes are utilized. Namely, a batch of sensors of the preferred embodiments can be designed with substantially the same baseline (b) and/or sensitivity (m) ( ⁇ 10%) when tested in vitro. Additionally, the sensor of the preferred embodiments can be designed for repeatable m and b in vivo.
  • an initial calibration factor (conversion function) can be programmed into the sensor (sensor electronics and/or receiver electronics) that enables conversion of raw sensor data into calibrated sensor data solely using information obtained prior to implantation (namely, initial calibration does not require a reference analyte value).
  • the sensor is designed to minimize drift of the sensitivity and/or baseline over time in vivo. Accordingly, the preferred embodiments can be manufactured for zero point calibration.
  • a sensor data transformation module also referred to as the calibration module, conversion module, or processor module, uses the conversion function to transform sensor data into substantially real-time analyte value estimates, also referred to as calibrated data, or converted sensor data, as sensor data is continuously (or intermittently) received from the sensor.
  • the sensor data which can be provided to the receiver in “counts,” is translated in to estimate analyte value(s) in mg/dL.
  • the offset value at any given point in time can be subtracted from the raw value (e.g., in counts) and divided by the slope to obtain the estimate analyte value:
  • an output module provides output to the user via the user interface.
  • the output is representative of the estimated analyte value, which is determined by converting the sensor data into a meaningful analyte value.
  • User output can be in the form of a numeric estimated analyte value, an indication of directional trend of analyte concentration, and/or a graphical representation of the estimated analyte data over a period of time, for example.
  • Other representations of the estimated analyte values are also possible, for example audio and tactile.
  • annotations are provided on the graph; for example, bitmap images are displayed thereon, which represent events experienced by the host. For example, information about meals, medications, insulin, exercise, sensor insertion, sleep, and the like, can be obtained by the receiver (by user input or receipt of a transmission from another device) and displayed on the graphical representation of the host's glucose over time. It is believed that illustrating a host's life events matched with a host's glucose concentration over time can be helpful in educating the host to his or her metabolic response to the various events.
  • the senor utilizes one or more additional electrodes to measure an additional analyte.
  • additional electrodes can provide a baseline or sensitivity measurement for use in calibrating the sensor.
  • baseline and/or sensitivity measurements can be used to trigger events such as digital filtering of data or suspending display of data, all of which are described in more detail in U.S. Publication No. US-2005-0143635-A1.
  • the saline drip can be changed to a known IV glucose or dextrose solution (e.g., D50—a 50% dextrose solution, or D5W—a 5% dextrose solution).
  • a known volume of D 5 W is infused into the host at a known rate over a predetermined period of time (e.g., 5, 10, 15 or 20 minutes, or for shorter or longer periods).
  • the senor measures the signal at the analyte-measuring working electrode.
  • the system knowing the specifications of the infused calibration solution (also referred to as a calibration information in some embodiments), can calibrate the signal to obtain host's glucose concentration as is appreciated by one skilled in the art.
  • two or more glucose or dextrose solutions can be infused, with a corresponding signal being measured during each infusion, to provide additional data for sensor calibration.
  • Calibration can be performed after the sensor has first been inserted into the host, after a break-in time, at two or more different levels (high/low), regularly, intermittently, in response to sensor drift/shift, automatically or any other time when calibration is required.
  • catheters are flushed with saline.
  • the analyte sensor system of the preferred embodiments can be flushed with saline prior to application of control solutions, after which a predetermined amount of glucose solution is flushed by the sensor, as described above, and the sensor is calibrated there from.
  • a blood sample can be withdrawn from an artery or vein, and used to calibrate the sensor, for example, by using a hand-held glucose meter, by an automatic extracorporeal glucose sensor such as but not limited to in conjunction with an automated bedside clinical chemistry device, or by sending the blood sample to the clinical laboratory for glucose analysis, after which the data is input (e.g., into the electronics associated with the sensor system).
  • the senor can be calibrated (and/or re-calibrated) during use (after initial calibration), for example, by withdrawing one or more blood samples (also referred to as calibration information in some embodiments), through the catheter (see FIGS. 1 and 2 ) and used for calibration of the sensor, such as by measuring the glucose concentration of the blood sample with an additional system, such as but not limited to a hand-held glucose meter, optical methods or additional electrochemical methods.
  • Blood samples can be withdrawn manually or automatically; additionally or alternatively, blood samples are withdrawn at regular intervals or at selected times, for example, using an extracorporeal blood analysis device as described herein.
  • a calibration solution e.g., 40 mg/dL equivalent glucose, D540 or D5W
  • a calibration solution can be flushed through or by the sensor to enable calibration of the sensor (e.g., at one time, intermittently, or continuously), such as described in more detail above.
  • calibration solution can be flushed manually or automatically through the system; additionally or alternatively, calibration solution can be flushed at regular intervals or at selected times.
  • the system can be provided with a dual lumen, one for saline and another for the control solution. Additionally, the system is configured to automatically switch from the saline to control solution and perform the real-time system calibration, and then switch back to the saline solution.
  • Glucose sensor systems of the embodiment shown in FIG. 1 were tested in dogs.
  • the glucose sensors were built according to the preferred embodiments described herein. Namely, a first sensor (Test 1) was built by providing a platinum wire, vapor-depositing the platinum with Parylene to form an insulating coating, helically winding a silver wire around the insulated platinum wire (to form a “twisted pair”), masking sections of the electroactive surface of the silver wire, vapor-depositing Parylene on the twisted pair, chloridizing the silver electrode to form a silver chloride reference electrode, and removing a radial window on the insulated platinum wire to expose a circumferential electroactive working electrode surface area thereon, this assembly also referred to as a “parylene-coated twisted pair assembly.”
  • An electrode domain was formed over the electroactive surface areas of the working and reference electrodes by dip coating the assembly in an electrode solution (comprising BAYHYDROL® 123, an aliphatic polycarbonate urethane resin) and drying.
  • An enzyme domain was formed over the electrode domain by subsequently dip coating the assembly in an enzyme solution (comprising BAYHYDROL® 140AQ, an aliphatic polyester urethane resin, and glucose oxidase) and drying.
  • a resistance domain was formed over the enzyme domain by spraying the resistance domain solution (comprising a blend of CHRONOTHANE®-1020 (a polyetherurethaneurea based on polytetramethylene glycol, methylene diisocyanate and organic amines) and CHRONOTHANE®-H (a polyetherurethaneurea based on polytetramethylene glycol, polyethylene glycol, methylene diisocyanate, and organic amines)) on the sensor construct.
  • CHRONOTHANE®-1020 a polyetherurethaneurea based on polytetramethylene glycol, methylene diisocyanate and organic amines
  • CHRONOTHANE®-H a polyetherurethaneurea based on polytetramethylene glycol, polyethylene glycol, methylene diisocyanate, and organic amines
  • the senor After the sensor was constructed, it was placed in the protective sheath and then threaded through and attached to the fluid coupler.
  • a second sensor was constructed in the same manner as the first, except that the silver wire was disposed within (e.g., coiled within) the fluid coupler. Accordingly, only the platinum working electrode (a single wire) was inserted into the catheter during the experiment.
  • the sensors Prior to use, the sensors were sterilized using electron beam.
  • the forelimb of an anesthetized dog (2 years old, ⁇ 40 pounds) was cut down to the femoral artery and vein.
  • An arterio-venous shunt was placed from the femoral artery to the femoral vein using 14 gauge catheters and 1 ⁇ 8-inch IV tubing.
  • a pressurized arterial fluid line was connected to the sensor systems at all times.
  • the test sensor systems (test 1 and test 2) included a 20 gauge ⁇ 1.25-inch catheter and took measurements every 30 seconds.
  • the catheter was aseptically inserted into the shunt, followed by insertion of the sensor into the catheter.
  • a transcutaneous glucose sensor (control) of the type disclosed in U.S. Publ. No. US-2006-0155180-A1 was built and placed in the dog's abdomen according to recommended procedures.
  • the dog was challenged with continuous incremental IV infusion of a 10% dextrose solution (“glucose challenge”) until the blood glucose concentration reached about 400 mg/dL.
  • glucose challenge a 10% dextrose
  • FIG. 4 shows the experimental results.
  • the thick line represents data collected from the Test 1 sensor.
  • the thin line represents data collected from the Test 2 sensor.
  • Diamonds represent data collected from a hand-held blood glucose meter (SMBG) sampled from the dog's abdomen.
  • Raw glucose test data (counts) are shown on the left-hand Y-axis
  • glucose concentrations for the “SMBG” controls are shown on the right-hand y-axis
  • time is shown on the X-axis.
  • Each time interval on the X-axis represents 29-minutes (e.g., 10:04 to 10:33 equals 29 minutes).
  • each test sensor began collecting data with substantially no sensor equilibration time (e.g., break-in time).
  • Each test sensor responded to the glucose challenge substantially similarly to the control sensor. For example, each device shows the glucose signal increasing from about 3200 counts at 10:33 to about 6000-6700 counts at 11:31. Then, each device showed a rapid decrease in glucose signal, to about 4700 counts at 12:00. Additionally, the response of the test sensors and the control sensor were substantially similar (e.g., the majority of the test data was substantially equivalent to the SMBG data at each time point). From these experimental show that an indwelling glucose sensor system (as described herein) in contact with the circulatory system can provide substantially continuous glucose monitoring in a clinical setting.
  • FIG. 5 shows the experimental results. Lines indicated the data from the four sensors (Test 1 through Test 4). Diamonds represent control measurements made with a hand-held glucose meter (SMBG).
  • SMBG hand-held glucose meter
  • Raw glucose test data (counts) are shown on the left-hand Y-axis, glucose concentrations for the “SMBG” controls are shown on the right-hand y-axis, and time is shown on the X-axis.
  • Test results show that though the sensors varied in sensitivity, each test sensor responded to glucose challenge substantially similarly to the control sensor (SMBG). These experimental results show that an indwelling glucose sensor system (of the preferred embodiments) in contact with the circulatory system can substantially continuously track glucose in a clinical setting.

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US11/543,396 US20080119703A1 (en) 2006-10-04 2006-10-04 Analyte sensor
US11/543,404 US8532730B2 (en) 2006-10-04 2006-10-04 Analyte sensor
US11/543,490 US8774886B2 (en) 2006-10-04 2006-10-04 Analyte sensor
US11/691,466 US7615007B2 (en) 2006-10-04 2007-03-26 Analyte sensor
US11/691,432 US7775975B2 (en) 2006-10-04 2007-03-26 Analyte sensor
US11/691,426 US20080108942A1 (en) 2006-10-04 2007-03-26 Analyte sensor
US11/691,424 US8911367B2 (en) 2006-10-04 2007-03-26 Analyte sensor
CNA2007800446434A CN101547633A (zh) 2006-10-04 2007-09-21 分析物传感器
EP14177544.5A EP2796090A1 (de) 2006-10-04 2007-09-21 Analytsensor
AU2007305002A AU2007305002B2 (en) 2006-10-04 2007-09-21 Analyte sensor
EP07843011.3A EP2091409B1 (de) 2006-10-04 2007-09-21 Analytsensor
CA002664426A CA2664426A1 (en) 2006-10-04 2007-09-21 Analyte sensor
JP2009531522A JP2010505534A (ja) 2006-10-04 2007-09-21 分析対象センサー
PCT/US2007/079220 WO2008042625A2 (en) 2006-10-04 2007-09-21 Analyte sensor
US12/055,149 US20080200788A1 (en) 2006-10-04 2008-03-25 Analyte sensor
US12/055,227 US8364230B2 (en) 2006-10-04 2008-03-25 Analyte sensor
US12/055,114 US8364231B2 (en) 2006-10-04 2008-03-25 Analyte sensor
US12/055,203 US8425416B2 (en) 2006-10-04 2008-03-25 Analyte sensor
US12/055,078 US20080197024A1 (en) 2003-12-05 2008-03-25 Analyte sensor
US12/267,547 US8298142B2 (en) 2006-10-04 2008-11-07 Analyte sensor
US12/267,545 US8275438B2 (en) 2006-10-04 2008-11-07 Analyte sensor
US12/267,546 US8449464B2 (en) 2006-10-04 2008-11-07 Analyte sensor
US12/267,544 US8478377B2 (en) 2006-10-04 2008-11-07 Analyte sensor
US12/267,494 US8425417B2 (en) 2003-12-05 2008-11-07 Integrated device for continuous in vivo analyte detection and simultaneous control of an infusion device
US12/267,518 US8287453B2 (en) 2003-12-05 2008-11-07 Analyte sensor
US12/267,548 US8562528B2 (en) 2006-10-04 2008-11-07 Analyte sensor
US12/267,525 US8626257B2 (en) 2003-08-01 2008-11-07 Analyte sensor
US12/267,531 US8447376B2 (en) 2006-10-04 2008-11-07 Analyte sensor
US12/267,542 US8886273B2 (en) 2003-08-01 2008-11-07 Analyte sensor
US12/535,620 US20090287074A1 (en) 2006-10-04 2009-08-04 Analyte sensor
US12/630,628 US20100081910A1 (en) 2006-10-04 2009-12-03 Analyte sensor
US12/713,607 US20100298684A1 (en) 2006-10-04 2010-02-26 Analyte sensor
US13/720,227 US9451908B2 (en) 2006-10-04 2012-12-19 Analyte sensor
US13/743,452 US9037210B2 (en) 2006-10-04 2013-01-17 Analyte sensor
US14/059,237 US20140088391A1 (en) 2006-10-04 2013-10-21 Analyte Sensor
US14/072,659 US10052055B2 (en) 2003-08-01 2013-11-05 Analyte sensor
US14/256,716 US20140213869A1 (en) 2006-10-04 2014-04-18 Analyte sensor
US15/140,307 US10349873B2 (en) 2006-10-04 2016-04-27 Analyte sensor
US16/036,808 US20180325437A1 (en) 2003-08-01 2018-07-16 Analyte sensor
US16/431,607 US20190282143A1 (en) 2006-10-04 2019-06-04 Analyte sensor
US16/526,910 US20190357827A1 (en) 2003-08-01 2019-07-30 Analyte sensor
US16/599,535 US11382539B2 (en) 2006-10-04 2019-10-11 Analyte sensor
US17/316,228 US20210259587A1 (en) 2003-08-01 2021-05-10 Analyte sensor
US18/087,171 US20230414140A1 (en) 2003-08-01 2022-12-22 Analyte sensor
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US11/543,404 Continuation-In-Part US8532730B2 (en) 2003-12-05 2006-10-04 Analyte sensor
US11/691,424 Continuation-In-Part US8911367B2 (en) 2003-12-05 2007-03-26 Analyte sensor
US11/691,466 Continuation-In-Part US7615007B2 (en) 2003-12-05 2007-03-26 Analyte sensor
US11/691,432 Continuation-In-Part US7775975B2 (en) 2003-12-05 2007-03-26 Analyte sensor
US11/691,426 Continuation-In-Part US20080108942A1 (en) 2003-12-05 2007-03-26 Analyte sensor
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US20100081910A1 (en) 2010-04-01
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US20080086044A1 (en) 2008-04-10
CA2664426A1 (en) 2008-04-10
US20140213869A1 (en) 2014-07-31
US20090287074A1 (en) 2009-11-19
US8911367B2 (en) 2014-12-16
CN101547633A (zh) 2009-09-30
US8532730B2 (en) 2013-09-10
AU2007305002A1 (en) 2008-04-10
US7775975B2 (en) 2010-08-17
US20080086273A1 (en) 2008-04-10
EP2091409B1 (de) 2014-08-27
US11382539B2 (en) 2022-07-12

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