Patent Grant
11564602
The present invention relates generally to systems and methods for monitoring glucose in a host. Particularly, a device for continuous glucose sensing is provided with an integrated receiver for single point glucose measurement and subsequent calibration of the continuous glucose sensor within the device.
A variety of continual and continuous glucose sensors have been developed for detecting and/or quantifying analytes in a biological fluid sample, for example, glucose sensors that continually or continuously measure glucose concentration in a host. Typically, these glucose sensors require a reference glucose measurement with which to calibrate the sensor-measured glucose values. Additionally, long-term implantable glucose sensors typically request regular updates of calibration, for example new reference glucose values every day, week, or month. Accordingly, a user has typically been required to keep track of and even stay close to (for example, carry) a device associated with the continuous glucose sensor that receives and processes data from the continuous glucose sensor. Additionally, a user has typically been required to carry a separate device that provides a reference glucose value for calibration of the continuous glucose sensor. Many times additional hardware, such as cables, test strips, and other auxiliary devices are necessary to connect, test, and otherwise use the devices. Therefore, the use of a continuous device can be cumbersome, particularly when the user is away from home.
Furthermore, continuous sensors have conventionally been calibrated using a reference glucose monitor that uses different measurement technology than that of the continuous sensor, which can increase the error within the calibrated sensor values. For example, an implantable glucose sensor that contains a membrane containing glucose oxidase is typically calibrated using self-monitoring blood glucose (SMBG) test strip-based measurement values. Unfortunately, such SMBG tests have an error of ±20% and additionally cannot be calibrated by the user. Furthermore, because the reference measurement device (for example, SMBG) is independent from the continuous glucose sensor, the possibility of accuracy in reporting time of SMGB can be prone to human error.
A continuous glucose sensor that includes simpler or fewer components than prior art sensors, that is user friendly, that exhibits reduced error within the calibrated sensor values, and/or is less prone to human error is desirable.
Accordingly, in a first embodiment, a device for monitoring glucose concentration in a biological sample of a host is provided, the device comprising a continuous glucose sensor that produces a data stream indicative of a host's glucose concentration; an integrated receiver that receives the data stream from the continuous glucose sensor, wherein the integrated receiver comprises a microprocessor comprising programming to process the data stream received from glucose sensor; and a single point glucose monitor adapted to receive a biological sample from the host and measure the concentration of glucose in the sample; wherein the microprocessor further comprises programming to calibrate the data stream using the glucose concentration measured by the single point glucose monitor.
In an aspect of the first embodiment, the continuous glucose sensor comprises a sensing membrane comprising an enzyme; and an electrochemical cell that measures the glucose concentration.
In an aspect of the first embodiment, the single point glucose monitor comprises a sensing membrane comprising an enzyme; and an electrochemical cell that measures a concentration of glucose in the sample.
In an aspect of the first embodiment, the integrated receiver further comprises a user interface for displaying glucose concentration data from at least one of the continuous glucose sensor and the single point glucose monitor.
In a second embodiment, a method for calibrating a continuous glucose sensor in an integrated receiver is provided, the method comprising continually receiving a data stream in the integrated receiver from a continuous glucose sensor; measuring a glucose concentration of a biological sample using a single point glucose monitor integral with the integrated receiver; and calibrating the data stream within the integrated receiver using the glucose concentration measured by the single point glucose monitor.
In an aspect of the second embodiment, the method further comprises the step of displaying the glucose concentration measured by the single point glucose monitor.
In an aspect of the second embodiment, the method further comprises the step of displaying a calibrated data stream.
In a third embodiment, a device for calibrating continuous glucose sensor data is provided, the device comprising a single point glucose monitor adapted to measure a glucose concentration in a biological sample; a receiver for receiving a data stream from a continuous glucose sensor; a microprocessor comprising programming to calibrate the data stream from the continuous glucose sensor using the glucose concentration measured from the single point glucose monitor.
In an aspect of the third embodiment, the continuous glucose sensor comprises a sensing membrane comprising an enzyme; and an electrochemical cell that measures the glucose concentration.
In an aspect of the third embodiment, the single point glucose monitor comprises a sensing membrane comprising an enzyme; and an electrochemical cell that measures the glucose concentration in the biological sample.
In an aspect of the third embodiment, the device further comprises a user interface adapted to display glucose data from at least one of the continuous glucose sensor and the single point glucose monitor.
In an aspect of the third embodiment, the glucose monitor comprises a sensing region comprising a sensing membrane and at least two electrodes, wherein the sensing region is located within the integrated receiver.
In an aspect of the third embodiment, the integrated receiver comprises a removable cartridge, and wherein the sensing region is located within the removable cartridge.
In an aspect of the third embodiment, the integrated receiver comprises a housing, and wherein the glucose monitor comprises a sensing region movably mounted to the integrated receiver housing.
In an aspect of the third embodiment, the device further comprises a stylus movably mounted to the integrated receiver housing, and wherein the sensing region is located on the stylus.
In an aspect of the third embodiment, the device further comprises a receiving chamber located within the integrated receiver housing, and wherein the stylus is received within the receiving chamber for storage.
In an aspect of the third embodiment, the device further comprises a sterile solution chamber located at an end of the receiving chamber such that the sensing region is operably associated with the sterile solution chamber when the stylus is received within the receiving chamber for storage.
In an aspect of the third embodiment, the device further comprises a sterile solution port configured for refilling the sterile solution chamber with a sterile solution.
In an aspect of the third embodiment, the device further comprises a dispensing chamber located in the integrated receiver housing, the dispensing chamber adapted to dispense at least one disposable bioprotective film onto the sensing region.
In an aspect of the third embodiment, the device further comprises a storage chamber located in the integrated receiver housing, the storage chamber adapted to store the disposable bioprotective film.
In an aspect of the third embodiment, the device further comprises a shuttle mechanism located on the integrated receiver housing, the shuttle mechanism adapted to load the disposable bioprotective film into the dispensing chamber.
In an aspect of the third embodiment, the device further comprises at least one bioprotective film that is adapted to stretch or stick onto the sensing region to protect the sensing region from damage, clogging, or contamination from a biological fluid.
In an aspect of the third embodiment, the bioprotective film further comprises a sensing membrane comprising an enzyme.
In an aspect of the third embodiment, the sensing region comprises a sensing membrane and at least two electrodes, wherein the sensing membrane is disposed over the electrodes adapted for measuring a glucose concentration in a biological sample.
In an aspect of the third embodiment, the single point glucose monitor comprises a sensor port that houses a sensing region adapted for measuring a glucose concentration in the biological sample.
In an aspect of the third embodiment, the device further comprises a disposable capillary tube, wherein the capillary tube is configured to create a capillary action capable of drawing a liquid biological sample from a first end of the tube to a second end of the tube.
In an aspect of the third embodiment, the capillary tube comprises a filter configured to permit passage of glucose, but to filter or block passage of an undesired species or a contaminating species in the biological sample.
In an aspect of the third embodiment, the capillary tube further comprises a vent configured to allow displaced air within the capillary tube to escape therefrom.
In an aspect of the third embodiment, n the sensor port comprises a cover adapted for protecting the sensing region.
In an aspect of the third embodiment, the disposable capillary tube comprises a sensing membrane, wherein the sensing membrane comprises a resistance domain, an enzyme domain, an interference domain, and an electrolyte domain.
In an aspect of the third embodiment, the single point glucose monitor and the receiver are detachably connected to each other.
In an aspect of the third embodiment, the single point glucose monitor and the receiver each comprise at least one contact adapted for operable connection when detachably connected to each other.
In an aspect of the third embodiment, the microprocessor is located within the receiver.
In an aspect of the third embodiment, the device further comprises a microprocessor located within the single point glucose monitor, wherein the microprocessor is adapted for communication between the single point glucose monitor and the receiver when the single point glucose monitor contact and the receiver contact are operably connected.
In a fourth embodiment, a device for monitoring a glucose concentration in a biological sample in a host is provided, the device comprising a continuous glucose sensor configured to produce a data stream indicative of a glucose concentration in a biological sample of a host, wherein the glucose sensor comprises a sensing membrane comprising a catalyst, wherein the membrane is operably associated with at least two electrodes that are operably connected to an electrical circuit adapted for continuous glucose sensing; a single point glucose monitor configured to produce a glucose concentration measurement from a biological sample obtained from a host, wherein the glucose monitor comprises a sensing membrane comprising a catalyst, wherein the membrane is operably associated with at least two electrodes that are operably connected to an electrical circuit adapted for measuring the glucose concentration in the biological sample; a receiver integral with the single point glucose monitor adapted to receive a data stream from the continuous glucose sensor; and a microprocessor integral with the single point glucose monitor that comprises programming to calibrate the data stream from the continuous glucose sensor using the glucose concentration measurement from the single point glucose monitor.
The following description and examples illustrate some exemplary embodiments of the disclosed invention in detail. Those of skill in the art will recognize that there are numerous variations and modifications of this invention that are encompassed by its scope. Accordingly, the description of a certain exemplary embodiment should not be deemed to limit the scope of the present invention.
In order to facilitate an understanding of the preferred embodiments, a number of terms are defined below.
The term “continuous glucose sensor,” as used herein, is a broad term and are used in its ordinary sense, including, without limitation, a device that continuously or continually measures glucose concentration, for example, at time intervals ranging from fractions of a second up to, for example, 1, 2, or 5 minutes, or longer. It should be understood that continuous glucose sensors can continually or continuously measure glucose concentration without requiring user initiation and/or interaction for each measurement, such as described with reference to U.S. Pat. No. 6,001,067, for example.
The phrase “continuous glucose sensing,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, the period in which monitoring of plasma glucose concentration is continuously or continually performed, for example, at time intervals ranging from fractions of a second up to, for example, 1, 2, or 5 minutes, or longer.
The term “single point glucose monitor,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, 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. Nos. 4,994,167 and 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.
The term “capillary action,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, the phenomenon of a liquid, such as water or blood, spontaneously creeping up a thin tube or fiber due to adhesive or cohesive forces or surface tension.
The term “biological sample,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, sample of a host body, for example blood, interstitial fluid, spinal fluid, saliva, urine, tears, sweat, or the like.
The term “host,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, mammals such as humans.
The term “biointerface membrane,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, a permeable or semi-permeable membrane that can include two or more domains and is typically constructed of materials of a few microns thickness or more, which can be placed over the sensing region to keep host cells (for example, macrophages) from gaining proximity to, and thereby damaging the sensing membrane or forming a barrier cell layer and interfering with the transport of glucose across the tissue-device interface.
The term “sensing membrane,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, a permeable or semi-permeable membrane that can be comprised of two or more domains and is typically constructed of materials of a few microns thickness or more, which are permeable to oxygen and are optionally permeable to glucose. In one example, the sensing membrane comprises an immobilized glucose oxidase enzyme, which enables an electrochemical reaction to occur to measure a concentration of glucose.
The term “domain,” as used herein is a broad term and is used in its ordinary sense, including, without limitation, regions of a membrane that can be layers, uniform or non-uniform gradients (for example, anisotropic), functional aspects of a material, or provided as portions of the membrane.
As used herein, the term “copolymer,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, polymers having two or more different repeat units and includes copolymers, terpolymers, tetrapolymers, etc.
The term “sensing region,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, the region of a monitoring device responsible for the detection of glucose. In one embodiment, the sensing region generally comprises a non-conductive body, a working electrode (anode), a reference electrode and a counter electrode (cathode) passing through and secured within the body forming an electrochemically reactive surface at one location on the body and an electronic connection at another location on the body, and a sensing membrane affixed to the body and covering the electrochemically reactive surface. During general operation of the sensor a biological sample (for example, blood or interstitial fluid) or a portion thereof contacts (for example, directly or after passage through one or more domains of the sensing membrane) an enzyme (for example, glucose oxidase); the reaction of the biological sample (or portion thereof) results in the formation of reaction products that allow a determination of the glucose level in the biological sample.
The term “electrochemically reactive surface,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, the surface of an electrode where an electrochemical reaction takes place. In the case of an electrochemical glucose sensor, hydrogen peroxide produced by an enzyme catalyzed reaction of the glucose being detected reacts at a working electrode creating a measurable electronic current (for example, detection of glucose utilizing glucose oxidase produces H2O2 as a by product, H2O2 reacts with the surface of the working electrode producing two protons (2H+), two electrons (2e−) and one molecule of oxygen (O2) which produces the electronic current being detected). In the case of the counter electrode, a reducible species (for example, O2) is reduced at the electrode surface in order to balance the current being generated by the working electrode.
The term “electrochemical cell,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, a device in which chemical energy is converted to electrical energy. Such a cell typically consists of two or more electrodes held apart from each other and in contact with an electrolyte solution. Connection of the electrodes to a source of direct electric current renders one of them negatively charged and the other positively charged. Positive ions in the electrolyte migrate to the negative electrode (cathode) and there combine with one or more electrons, losing part or all of their charge and becoming new ions having lower charge or neutral atoms or molecules; at the same time, negative ions migrate to the positive electrode (anode) and transfer one or more electrons to it, also becoming new ions or neutral particles. The overall effect of the two processes is the transfer of electrons from the negative ions to the positive ions, a chemical reaction.
The term “proximal” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, near to a point of reference such as an origin or a point of attachment. For example, in some embodiments of a sensing membrane that covers an electrochemically reactive surface, the electrolyte domain is located more proximal to the electrochemically reactive surface than the interference domain.
The term “distal” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, spaced relatively far from a point of reference, such as an origin or a point of attachment. For example, in some embodiments of a sensing membrane that covers an electrochemically reactive surface, a resistance domain is located more distal to the electrochemically reactive surfaces than the enzyme domain.
The term “substantially” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, being largely but not necessarily wholly that which is specified.
The terms “microprocessor” and “processor,” as used herein, are broad terms and are used in their ordinary sense, including, without limitation, a computer system or state machine designed to perform arithmetic and logic operations using logic circuitry that responds to and processes the basic instructions that drive a computer.
The term “EEPROM,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, electrically erasable programmable read-only memory, which is user-modifiable read-only memory (ROM) that can be erased and reprogrammed (for example, written to) repeatedly through the application of higher than normal electrical voltage.
The term “SRAM,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, static random access memory (RAM) that retains data bits in its memory as long as power is being supplied.
The term “A/D Converter,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, hardware and/or software that converts analog electrical signals into corresponding digital signals.
The term “RF transceiver,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, a radio frequency transmitter and/or receiver for transmitting and/or receiving signals.
The terms “raw data stream” and “data stream,” as used herein, are broad terms and are used in their ordinary sense, including, without limitation, an analog or digital signal directly related to the measured glucose from the glucose sensor. In one example, 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 a glucose concentration. The terms broadly encompass a plurality of time spaced data points from a substantially continuous glucose sensor, 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 term “counts,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, a unit of measurement of a digital signal. In one example, a raw data stream 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. In another example, counter electrode voltage measured in counts is directly related to a voltage.
The term “electronic circuitry,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, the components (for example, hardware and/or software) of a device configured to process data. In the case of a glucose-measuring device, the data includes biological information obtained by a sensor regarding a particular glucose in a biological fluid, thereby providing data regarding the amount of that glucose in the fluid. U.S. Pat. Nos. 4,757,022, 5,497,772 and 4,787,398, which are hereby incorporated by reference, describe suitable electronic circuits that can be utilized with devices of the preferred embodiments.
The term “potentiostat,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, an electrical system that applies a potential between the working and reference electrodes of a two- or three-electrode cell at a preset value and measures the current flow through the working electrode. The potentiostat forces whatever current is necessary to flow between the working and reference (2 electrode) or counter (3 electrode) 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 term “electrical potential,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, the electrical potential difference between two points in a circuit which is the cause of the flow of a current.
The terms “operably connected” and “operably linked,” as used herein, are broad terms and are used in their ordinary sense, including, without limitation, one or more components being linked to another component(s) in a manner that allows transmission of signals between the components. For example, one or more electrodes can be used to detect the amount of glucose in a sample and convert that information into a signal. The signal can then be transmitted to an electronic circuit. In this case, the electrode is “operably linked” to the electronic circuit. These terms are broad enough to include wireless connectivity.
The term “linear regression,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, finding a line in which a set of data has a minimal measurement from that line. Byproducts of this algorithm include a slope, a y-intercept, and an R-Squared value that determine how well the measurement data fits the line.
The term “non-linear regression,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, fitting a set of data to describe the relationship between a response variable and one or more explanatory variables in a non-linear fashion.
Overview
Continuous Glucose Sensor
The preferred embodiments provide a continuous glucose sensor that measures a concentration of glucose or a substance indicative of the concentration or presence of the glucose. In some embodiments, the glucose sensor is an invasive, minimally-invasive, or non-invasive device, for example a subcutaneous, transdermal, or intravascular device. In some embodiments, the device can analyze a plurality of intermittent biological samples. The glucose sensor can use any method of glucose-measurement, including enzymatic, chemical, physical, electrochemical, spectrophotometric, polarimetric, calorimetric, radiometric, or the like. In alternative embodiments, the sensor can be any sensor capable of determining the level of an analyte in the body, for example oxygen, lactase, hormones, cholesterol, medicaments, viruses, or the like.
The glucose sensor uses any known method to provide an output signal indicative of the concentration of the glucose. The output signal is typically a raw data stream that is used to provide a useful value of the measured glucose concentration to a patient or doctor, for example.
One exemplary embodiment is described in detail below, which utilizes an implantable glucose sensor. However, it should be understood that the devices and methods described herein can be applied to any device capable of continually or continuously detecting a concentration of analyte of interest and providing an output signal that represents the concentration of that analyte.
In one embodiment, the three electrodes 22 include a platinum working electrode, a platinum counter electrode, and a silver/silver chloride reference electrode. The top ends of the electrodes are in contact with an electrolyte phase (not shown), which is a free-flowing fluid phase disposed between the sensing membrane 23 and the electrodes 22. The sensing membrane 23 includes an enzyme, for example, glucose oxidase, and covers the electrolyte phase. The biointerface membrane 24 covers the sensing membrane 23 and serves, at least in part, to protect the sensor 10a from external forces that can result in environmental stress cracking of the sensing membrane 23. Copending U.S. patent application Ser. No. 10/647,065, entitled, “POROUS MEMBRANES FOR USE WITH IMPLANTABLE DEVICES,” describes a biointerface membrane that can be used in conjunction with the preferred embodiments, and is incorporated herein by reference in its entirety.
In one embodiment, the biointerface membrane 24 generally includes a cell disruptive domain most distal from the electrochemically reactive surfaces and a cell impermeable domain less distal from the electrochemically reactive surfaces than the cell disruptive domain. The cell disruptive domain is preferably designed to support tissue ingrowth, disrupt contractile forces typically found in a foreign body response, encourage vascularity within the membrane, and disrupt the formation of a barrier cell layer. The cell impermeable domain is preferably resistant to cellular attachment, impermeable to cells, and composed of a biostable material.
In one embodiment, the sensing membrane 23 generally provides one or more of the following functions: 1) protection of the exposed electrode surface from the biological environment, 2) diffusion resistance (limitation) of the analyte, 3) a catalyst for enabling an enzymatic reaction, 4) limitation or blocking of interfering species, and 5) hydrophilicity at the electrochemically reactive surfaces of the sensor interface, such as described in U.S. patent application Ser. No. 10/838,912, filed May 3, 2004 and entitled “IMPLANTABLE ANALYTE SENSOR,” which is incorporated herein by reference in its entirety. Accordingly, the sensing membrane 23 preferably includes a plurality of domains or layers, for example, an electrolyte domain, an interference domain, an enzyme domain (for example, glucose oxidase), a resistance domain, and can additionally include an oxygen domain (not shown), and/or a bioprotective domain (not shown), such as described in more detail in the above-cited U.S. patent application Ser. No. 10/838,912. However, it is understood that a sensing membrane modified for other devices, for example, by including fewer or additional domains is within the scope of the preferred embodiments.
In some embodiments, the domains of the biointerface and sensing membranes are formed from materials 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. U. S. patent application Ser. No. 10/838,912, which is incorporated herein by reference in its entirety, describes biointerface and sensing membrane configurations and materials that can be applied to the preferred embodiments.
In the illustrated embodiment, the counter electrode is provided to balance the current generated by the species being measured at the working electrode. In the case of a glucose oxidase based glucose sensor, the species being measured at the working electrode is H2O2. Glucose oxidase catalyzes the conversion of oxygen and glucose to hydrogen peroxide and gluconate according to the following reaction:
Glucose+O2→Gluconate+H2O2
The change in H2O2 can be monitored to determine glucose concentration because for each glucose molecule metabolized, there is a proportional change in the product H2O2. Oxidation of H2O2 by the working electrode is balanced by reduction of ambient oxygen, enzyme generated H2O2, or other reducible species at the counter electrode. The H2O2 produced from the glucose oxidase reaction further reacts at the surface of working electrode and produces two protons (2H+), two electrons (2e−), and one oxygen molecule (O2).
In one embodiment, a potentiostat is employed to monitor the electrochemical reaction at the electrochemical cell. The potentiostat applies a constant potential to the working and reference electrodes to determine a current value. The current that is produced at the working electrode (and flows through the circuitry to the counter electrode) is substantially proportional to the amount of H2O2 that diffuses to the working electrode. Accordingly, a raw signal can be produced that is representative of the concentration of glucose in the user's body, and therefore can be utilized to estimate a meaningful glucose value, such as described herein.
In this embodiment, the in vivo portion of the sensor 10b is the portion adapted for insertion under the host's skin, while an ex vivo portion of the sensor 10b is the portion that remains above the host's skin after sensor insertion and operably connects to an electronics unit (not shown). The sensor 10b two or more electrodes: a working electrode 26 and at least one additional electrode 28, which can function as a counter and/or reference electrode, hereinafter referred to as the reference electrode. Each electrode is formed from a fine wire, with a diameter in the range of 0.001 to 0.010 inches, for example, and can be formed from plated wire or bulk material.
In one embodiment, the working electrode 26 comprises a wire formed from a conductive material, such as platinum, palladium, graphite, gold, carbon, conductive polymer, or the like. The working electrode 26 is configured and arranged to measure the concentration of an analyte. The working electrode 20 is covered with an insulating material, for example a non-conductive polymer. Dip-coating, spray-coating, or other coating or deposition techniques can be used to deposit the insulating material on the working electrode, for example. In one preferred embodiment, the insulating material comprises Parylene, which can be an advantageous conformal coating for its strength, lubricity, and electrical insulation properties, however, a variety of other insulating materials can be used, for example, fluorinated polymers, polyethyleneterephthalate, polyurethane, polyimide, or the like.
The reference electrode 28, which can function as a reference electrode alone, or as a dual reference and counter electrode, is formed from silver, Silver/Silver chloride, or the like. In one embodiment, the reference electrode 28 is formed from a flat wire with rounded edges in order to decrease sharp edges and increase host comfort. Preferably, the reference electrode 28 is juxtapositioned and/or twisted with or around the working electrode 26; however other configurations are also possible. In some embodiments, the reference electrode 28 is helically wound around the working electrode 26 (see
A sensing membrane (not shown) is deposited over the electroactive surfaces of the sensor 10b (working electrode and optionally reference electrode) and includes a plurality of domains or layers, such as described above, with reference to
In the illustrated embodiment, the sensor glucose oxidase electrochemical sensor, wherein the working electrode 26 measures the hydrogen peroxide produced by an enzyme catalyzed reaction of the analyte being detected and creates a measurable electronic current (for example, detection of glucose utilizing glucose oxidase produces H2O2 peroxide as a by product, H2O2 reacts with the surface of the working electrode producing two protons (2H+), two electrons (2e−) and one molecule of oxygen (O2) which produces the electronic current being detected), such as described in more detail above and as is appreciated by one skilled in the art.
A microprocessor 34 is the central control unit that houses EEPROM 36 and SRAM 38, and controls the processing of the sensor electronics. Certain alternative embodiments can utilize a computer system other than a microprocessor to process data as described herein. In other alternative embodiments, an application-specific integrated circuit (ASIC) can be used for some or all the sensor's central processing. The EEPROM 36 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 described in U.S. patent application entitled, “SYSTEMS AND METHODS FOR REPLACING SIGNAL ARTIFACTS IN A GLUCOSE SENSOR DATA STREAM,” filed Aug. 22, 2003). The SRAM 38 can be used for the system's cache memory, for example for temporarily storing recent sensor data. In some alternative embodiments, memory storage components comparable to EEPROM and SRAM can be used instead of or in addition to the preferred hardware, such as dynamic RAM, non-static RAM, rewritable ROMs, flash memory, or the like.
A battery 40 is operably connected to the microprocessor 34 and provides the necessary power for the sensor 10. In one embodiment, the battery is a Lithium Manganese Dioxide battery, however any appropriately sized and powered battery can be used (for example, AAA, Nickel-cadmium, Zinc-carbon, Alkaline, Lithium, Nickel-metal hydride, Lithium-ion, Zinc-air, Zinc-mercury oxide, Silver-zinc, and/or hermetically-sealed). In some embodiments the battery is rechargeable. In some embodiments, a plurality of batteries can be used to power the system. A Quartz Crystal 42 is operably connected to the microprocessor 34 and maintains system time for the computer system as a whole.
An RF Transceiver 44 is operably connected to the microprocessor 34 and transmits the sensor data from the sensor 10 to a receiver (see
In one alternative embodiment, the continuous glucose sensor comprises a transcutaneous sensor such as described in U.S. Pat. No. 6,565,509 to Say et al. In another alternative embodiment, the continuous glucose sensor comprises a subcutaneous sensor such as described with reference to U.S. Pat. No. 6,579,690 to Bonnecaze et al. or U.S. Pat. No. 6,484,046 to Say et al. In another alternative embodiment, the continuous glucose sensor comprises a refillable subcutaneous sensor such as described with reference to U.S. Pat. No. 6,512,939 to Colvin et al. In another alternative embodiment, the continuous glucose sensor comprises an intravascular sensor such as described with reference to U.S. Pat. No. 6,477,395 to Schulman et al. In another alternative embodiment, the continuous glucose sensor comprises an intravascular sensor such as described with reference to U.S. Pat. No. 6,424,847 to Mastrototaro et al. All of the above patents are incorporated in their entirety herein by reference.
Although a few exemplary embodiments of continuous glucose sensors are illustrated and described herein, it should be understood that the disclosed embodiments are applicable to a variety of continuous glucose sensor configurations.
Integrated Receiver
The integrated receiver provides an integrated housing that includes a single point glucose monitor, electronics (for example, hardware and software) useful to receive and process data from the continuous glucose sensor and the single point glucose monitor, and a user interface that displays processed data to a user (for example, patient or doctor).
In the illustrated embodiments, the single point glucose monitor includes a meter for measuring glucose within a biological sample including a sensing region that has a sensing membrane impregnated with an enzyme, similar to the sensing membrane described with reference to
The integrated receiver 12 includes a main housing 62 and a cartridge 64 that is removably mounted on the housing 62, which permits the cartridge 64 to be disposable and replaceable as needed. The housing 62 includes a case 66 having an upper portion 68 and a lower portion 70. The upper portion 68 and lower portion 70 are connected together by any particular fastening means such as several screws (not shown).
The main housing 62 also includes electronic circuitry operably connected to at least two electrodes (not shown). The electrodes are preferably mounted within a sensing region 72 that supports the electrodes as they extend upwardly therein. A sensing membrane (not shown) overlays the electrodes on the sensing region 72 and is operably associated with the electrodes when the cartridge is removably mounted on the housing. The cartridge 64 also includes means for protecting the sensing membrane when not in use. The protection means is preferably a cover 74 that is movably mounted on a body portion 76 of the cartridge 64. Alternatively, the cover 74 can be mounted on the case 66. In the illustrated embodiment, a hinge assembly 78 movably mounts the cover 74 on the body portion 76.
Generally, the cover 74 has a first position such as shown in
The housing 62 preferably defines a well 80 having a bottom 82. In practice, the biological fluid sample is placed on the sensing region 72 in the well 80 for analysis. Generally, the well 80 defines an opening of less than 4 millimeters in diameter and less than 2 millimeters in depth. As a result, the well has a volume of less than about 0.1 to 0.2 cubic centimeters. These dimensions substantially minimize the size of the biological fluid sample necessary for analysis down to the sample sizes as small as about five microliters. Because the size of the sample can be particularly small, compensation for temperature changes during analysis that was often necessary with previous devices can be avoided.
The protection means of the cartridge 64 preferably also includes means for sealing the well 80 and hence the sensing region including the sensing membrane, which is disposed at the bottom of the well 80, from the ambient surroundings.
A retaining means is also provided for releasably retaining the cartridge 64 and its body portion 76 on the housing 62. The retaining means preferably includes a detent 84 on the cartridge 64, which is received in a recess defined by the upper portion 68 of the case 66. The retaining means also preferably includes at least one, preferably two wings 86 on the body portion 76 of the cartridge 64 which are received in one or more slots 88 on the case 66. The slots 88 are generally perpendicular to the cover 74 so that opening the cover will not disengage the wings 86 from the slots 88.
The sensing region 72, in which the electrodes are disposed, is preferably generally annular in design with the interior portion thereof filled with an electrically nonconductive support material such as a hardened polyepoxide-containing resin. The electrically nonconductive support material and the top (electrochemically reactive) surfaces of the electrodes define a sensing membrane contact surface. Namely, the sensing membrane can be stretched over the contact surface to more effectively place the membrane in operative association with the electrodes (not shown). In an alternative embodiment of the sensing region 72, the electrodes can be deposited onto a ceramic surface, and an electrically nonconductive material can be applied as a coating over the electrodes to form an insulating barrier. A portion of each electrode, however, is not coated to form a membrane contact surface so that a membrane can be applied over the electrodes in operative contact therewith.
Generally, the sensing membrane can be constructed substantially similar to the sensing membrane described with reference to
In some embodiments, the domains of the sensing membrane are formed from materials 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.
The cover 74 is preferably provided with a closure means (not shown) such as one or more latches that engage the body portion 76. Generally, the force necessary to disengage the closure means from the body portion should be less than that necessary to disengage the wings 86 from the slots 88. In this manner, an operator can easily open the cover 74 without accidentally disengaging the cartridge 64 from the main housing 62.
The sensing region 72, including the electrodes and sensing membrane, contacts the body fluid sample for analysis. The sensing region 72 is operably associated with the electronic circuitry (see
In one embodiment, the electrode configuration includes a three-electrode electrochemical cell, which in combination with the chemical reactions occurring in the sensing membrane and on the electrochemically reactive surfaces, makes possible consistent electrode behavior and, in particular, performance of a reference electrode that is stable with time. However, in alternative embodiments, wherein the electrode configuration includes a two-electrode electrochemical cell with a reference cathodic, chloride ions will be lost from the reference electrode that eventually leads to unstable electrode behavior. According to the preferred embodiments, permanent stable reference electrode behavior is achieved when the hydrogen peroxide produced in the membrane oxidizes the silver metal to silver oxide which is then converted to silver chloride by chloride ion. Advantages include ease of manufacturing of the electrode, self-forming and self-maintaining electrode behavior, and long-term reference electrode stability.
In general, the glucose measurement technique of the integrated receiver 12 is similar to that described with reference to
The single point glucose monitor described with reference to
Additionally, the similarity of the sensing membranes used for the continuous glucose sensor and the single point glucose sensor provides an internal control that creates increased reliability by nature of consistency and decreased error potential that can otherwise be increased due to combining dissimilar measurement techniques. Additionally, the disclosed membrane system is known to provide longevity, repeatability, and cost effectiveness, for example as compared to single use strips, or the like.
During the data processing, prompts or messages can be displayed on the user interface 16 to guide the user through the calibration and sample measurement procedures. In addition, prompts can be displayed to inform the user about necessary maintenance procedures, such as “Replace Sensor” or “Replace Battery.” An on/off button 90 preferably initiates the operation and calibration sequences.
Methods and devices that can be suitable for use in conjunction with aspects of the above-described preferred embodiments are disclosed in applications including U.S. Pat. Nos. 4,994,167 and 4,757,022. The integrated receiver electronics and its integration with the continuous glucose sensor are described in more detail below with reference to
In this embodiment, the integrated receiver provides 92 a housing that integrates a single point glucose monitor 94 and electronics (see
The single point glucose monitor 94 includes a stylus 98 that is movably mounted to the integrated receiver housing 92 via a connector 93. The connector 93 can be a cord, bar, hinge, or any such connection means that allows the stylus to move from a first (storage) position (
The stylus 98 includes a sensing region 100 on one end that is operably connected to the integrated receiver's electronics (
In order to maintain a preferred wetness of the sensing region 100, and particularly of the sensing membrane, the integrated receiver housing 92 includes a sterile solution chamber (not shown) located at the end of the receiving chamber 104 that receives the stylus for storage, such that when the stylus is in its storage position (
Typically, when a biological sample 106 (
In some alternative embodiments, the bioprotective film 109 further comprises a sensing membrane formed as a part of the film (for example, laminated to the film), instead of (or in addition to) a sensing membrane disposed on the sensing region. This alternative embodiment is particularly advantageous in that it provides a disposable sensing membrane that requires no cleaning step, for example.
Because the stylus 98 can be put into direct contact with the biological sample 106 (for example, on a finger or arm), no transfer mechanism is required, and therefore the sample size can be smaller than conventionally required. Additionally, sensing region 100 does not require a separate cleaning step, because the disposable film 109 fully protects the sensing region 100 from contamination, and should be disposed of after use.
The integrated receiver 92 housing further allows for storage and dispensing of the disposable films 109. A shuttle mechanism 110 is provided that preferably feeds the films 109 into a spring-loaded storage chamber (not shown) beneath the shuttle mechanism 110, or the like. The shuttle mechanism 110 can be used to load the disposable films 109, one at a time, into a dispensing chamber 111 for dispensing onto the sensing region. In alternative embodiments, other storage and dispensing mechanisms can be configured as a part of the integrated receiver housing 12 or separate therefrom.
In practice, the stylus 98 is held in its storage position within the receiving chamber 104 where it is protected and maintained with a preferred wetness (
In this embodiment, the sensing region measures the glucose concentration of the biological sample in a manner such as described with reference to
In this embodiment, the integrated receiver provides a housing 112 that integrates a single point glucose monitor 114 and electronics (see
The single point glucose monitor 114 includes a sensor port 120 configured to receive a biological fluid and measure its glucose concentration therefrom. As best illustrated in
Typically, when a biological sample is placed in on a surface (e.g., the sensing membrane 124), there is a concern about contamination of the surface from the biological sample. Therefore, a single-use disposable capillary tube 132 can be provided to transport and filter the biological sample, for example from a blood sample of a finger or arm, to the sensing region 122. The disposable capillary tube 132 uses capillary action to draw the biological sample from a first end 134 to a second end 136 of the capillary tube 132. A filter 140 is provided within the capillary tube 132, which is designed to allow the passage of glucose, but filter or block the passage of undesired species in the biological sample that could damage or contaminate the sensing membrane and/or cause inaccurate measurements (for example, the filter can be formed from a membrane of very low molecular weight cutoff to prevent the transport of proteins, viruses, etc). Because the filter 140 protects the sensing region 122 from contamination, the sensing region does not require a separate cleaning step, and the filter should be disposed of after use.
Referring now to
Referring now to
The capillary tubes 132 can be manufactured using materials such as plastic, glass, silicon, or the like. In one embodiment, the preferred manufacturing material is plastic because of its low cost and the availability of numerous manufacturing processes. The inner capillary tube 144 can be molded or embossed to form the capillary structure. In some alternative embodiments, such as shown
In some embodiments, it can be advantageous to place a means of detecting a proper fill of the capillary. This can be accomplished for example by electrical means, optical means, or the like. In some embodiments (not shown), the integrated receiver housing 112 can be designed with a means for storing and dispensing capillary tubes 132. In alternative embodiments, other storage and/or dispensing means can be configured separate from the integrated receiver housing 112.
In practice, a user obtains a biological sample from a source, such as a finger or forearm (in some alternative embodiments, the single point glucose monitor can by designed to measure biological fluids other than blood, such as urine, sweat, or the like). The user then grasps a disposable capillary tube 132 (e.g., tab or outer surface) and contacts the source with the capillary inlet 142. Because of the design of the inner capillary tube 144, capillary action causes the biological sample to be drawn towards the capillary outlet 146. The biological sample is filtered as it passes through the filter 140, which is permeable to glucose but impermeable to large molecules and species in the blood that can clog, damage, or contaminate the sensing membrane 124, and/or cause inaccurate measurements. Therefore, the biological sample permeates the filter 140 and into the sensing membrane 124 (for example, fluid contact between the capillary tube and sensing membrane enables the transfer of the filtered biological sample), where it enyzmatically reacts with the catalyst (e.g., glucose oxidase) and produces hydrogen peroxide. Hydrogen peroxide is detected by the electrochemical sensor, wherein the electrical signal is converted into glucose value, such as described in more detail elsewhere herein.
The sensing membrane 124 is a reusable component of the single point glucose monitor, which advantageously provides a low cost associated with each glucose measurement as compared to conventional glucose measuring test strips. Additionally, the disposable capillary tube 132 simplifies the cleanup of the device, as compared to conventional single point glucose monitors that utilize similar enzyme membrane technology. Furthermore, because the blood remains within the capillary tube 144, which can be disposed of without contaminating the integrated receiver housing 112 or the sensing membrane 124, the risk of human contact with blood is reduced.
In this embodiment, the integrated receiver 150 provides a receiver housing 152 and a single point glucose monitor 154, which are detachably connectable to each other. The receiver housing 152 includes electronics (hardware and software) useful to receive, process, and display data from the continuous glucose sensor and/or the single point glucose sensor on a user interface 156, such as described in more detail with reference to
In general, this embodiment provides for a modular configuration between a receiver housing 152 and a single point glucose monitor 154, wherein the single point glucose monitor can be detached when a user prefers to carry a smaller, simpler, or lighter device (for example, during exercise). However, when a user is ready to perform a single point glucose test, the glucose monitor 154 can be easily attached to the receiver 152 to form an integrated receiver 150 with its numerous associated advantages. In one embodiment, electrical contacts (not shown) on the receiver housing 152 and the single point glucose monitor 154 allow an electrical connection to be established in its attached position. In another embodiment, a wireless connection between the receiver housing 152 and the single point glucose monitor 154 can be provided, wherein the integration is advantageous for its convenient one-piece system (for example, fewer loose parts), its similar measurement technologies (for example, enzyme membrane-based electrochemical measurement), and its added versatility to function even when the modular device is detached.
While not required, it is preferred in this embodiment that the single point glucose monitor 154 be dependent upon the integrated receiver 152 for at least a portion of its operation. For example, at least some of the electronics and/or user interface for the single point glucose monitor 154 are located within the receiver 152. Numerous advantages associated with the integrated receiver 150, such as ensuring accurate time stamping of the single point glucose test at the receiver and other advantages described herein, can be provided by an integrated continuous glucose receiver and single point glucose monitor, such as described herein.
Additionally, the integrated receiver housing configurations of the preferred embodiments are advantageous in that they can be calibrated by the user and can be designed with a measurement technique consistent with that of the continuous glucose sensor. These and other advantages can be seen in alternative embodiments of the device of the preferred embodiments, which are described in more detail elsewhere herein.
In one alternative embodiment, the single point glucose monitor comprises an integrated lancing and measurement device such as described in U.S. Pat. No. 6,607,658 to Heller et al. In another alternative embodiment, the single point glucose monitor comprises a near infrared device such as described in U.S. Pat. No. 5,068,536 to Rosenthal et al. In another alternative embodiment, the single point glucose monitor comprises an integrated lancer, blood-monitoring device, and medication delivery pen, such as described in U.S. Pat. No. 6,192,891 to Gravel et al. In another alternative embodiment, the single point glucose monitor comprises a reflectance reading apparatus such as described in U.S. Pat. No. 5,426,032 to Phillips et al. In another alternative embodiment, the single point glucose monitor comprises a spectroscopic transflectance device such as described in U.S. Pat. No. 6,309,884 to Cooper et al. Other integrations that can be combined with the integrated receiver are described in U.S. patent application Ser. No. 10/789,359, filed Feb. 26, 2004. All of the above patents and patent applications are incorporated in their entirety herein by reference.
A quartz crystal 160 is operably connected to an RF transceiver 162, which together function to receive and synchronize data streams 164 via an antenna 166 (for example, transmission 46 from the RF transceiver 44 shown in
The microprocessor 168 is the central control unit that provides the processing, such as storing data, analyzing continuous glucose sensor data stream, analyzing single point glucose values, accuracy checking, checking clinical acceptability, calibrating sensor data, downloading data, and controlling the user interface by providing prompts, messages, warnings and alarms, or the like. The EEPROM 170 is operably connected to the microprocessor 168 and provides semi-permanent storage of data, storing data such as receiver ID and programming to process data streams (for example, programming for performing calibration and other algorithms described elsewhere herein). SRAM 172 is used for the system's cache memory and is helpful in data processing. For example, the SRAM stores information from the continuous glucose sensor and the single point glucose monitor for later recall by the user or a doctor; a user or doctor can transcribe the stored information at a later time to determine compliance with the medical regimen or a comparison of glucose concentration to medication administration (for example, this can be accomplished by downloading the information through the pc com port 174). In addition, the SRAM 172 can also store updated program instructions and/or patient specific information.
A battery 176 is operably connected to the microprocessor 168 and provides power for the receiver. In one embodiment, the battery is a standard AAA alkaline battery, however any appropriately sized and powered battery can be used. In some embodiments, a plurality of batteries can be used to power the system. In some embodiments, a power port (not shown) is provided permit recharging of rechargeable batteries. A quartz crystal 178 is operably connected to the microprocessor 168 and maintains system time for the computer system as a whole.
A PC communication (com) port 174 can be provided to enable communication with systems, for example, a serial communications port, allows for communicating with another computer system (for example, PC, PDA, server, or the like). In one exemplary embodiment, the receiver is able to download historical data to a physician's PC for retrospective analysis by the physician. The PC communication port 174 can also be used to interface with other medical devices, for example pacemakers, implanted analyte sensor patches, infusion devices, telemetry devices, or the like.
Electronics associated with the single point glucose monitor 180 are operably connected to the microprocessor 168 and include a potentiostat 181 in one embodiment that measures a current flow produced at the working electrode when a biological sample is placed on the sensing membrane, such as described with reference to
A user interface 184 comprises a keyboard 186, speaker 188, vibrator 190, backlight 192, liquid crystal display (LCD) 194, and one or more buttons 196. The components that comprise the user interface 184 provide controls to interact with the user. The keyboard 186 can allow, for example, input of user information about an individual, such as mealtime, exercise, insulin administration, and reference glucose values. The speaker 188 can provide, for example, audible signals or alerts for conditions such as present and/or predicted hyper- and hypoglycemic conditions. The vibrator 190 can provide, for example, tactile signals or alerts for reasons such as described with reference to the speaker, above. The backlight 192 can be provided, for example, to aid the user in reading the LCD in low light conditions. The LCD 194 can be provided, for example, to provide the user with visual data output. In some embodiments, the LCD is a touch-activated screen. The buttons 196 can provide for toggle, menu selection, option selection, mode selection, and reset, for example. In some alternative embodiments, a microphone can be provided to allow for voice-activated control.
The user interface 184, which is operably connected to the microprocessor 168 serves to provide data input and output for both the continuous glucose sensor (for example,
In some embodiments, prompts or messages can be displayed on the user interface to guide the user through the initial calibration and sample measurement procedures for the single point glucose monitor. Additionally, prompts can be displayed to inform the user about necessary maintenance procedures, such as “Replace Sensing Membrane” or “Replace Battery.” Even more, the glucose concentration value measured from the single point glucose monitor can be individually displayed.
In some embodiments, prompts or messages can be displayed on the user interface to convey information to the user, such as malfunction, outlier values, missed data transmissions, or the like, for the continuous glucose sensor. Additionally, prompts can be displayed to guide the user through calibration of the continuous glucose sensor. Even more, calibrated sensor glucose data, which is described in more detail with reference to
Reference is now made to
At block 200, a sensor data receiving module, also referred to as the sensor data module, receives sensor data (for example, a data stream), including one or more time-spaced sensor data points, hereinafter referred to as “sensor data” or “sensor glucose data.” The integrated receiver receives the sensor data from a continuous glucose sensor, which can be in wired or wireless communication with the integrated receiver. Some or all of the sensor data point(s) can be smoothed or replaced by estimated signal values such as described with reference to U.S. patent application entitled, “SYSTEMS AND METHODS FOR REPLACING SIGNAL ARTIFACTS IN A GLUCOSE SENSOR DATA STREAM,” filed Aug. 22, 2003. During the initialization of the sensor, prior to initial calibration, the integrated receiver (for example,
At block 202 a single point glucose module, also referred to as the reference input module, receives glucose data from the integrated single point glucose monitor, including one or more reference glucose data points, hereinafter referred as “reference data” or “reference glucose data.” Namely, the single point glucose monitor, such as described in more detail with reference to
In some embodiments, the microprocessor 168 monitors the continuous glucose sensor data stream to determine a preferable time for capturing glucose concentration values using the single point glucose monitor electronics 180 for calibration of the continuous sensor data stream. For example, when sensor glucose data (for example, observed from the data stream) changes too rapidly, a single point glucose monitor reading may not be sufficiently reliable for calibration during unstable glucose changes in the host; in contrast, when sensor glucose data are relatively stable (for example, relatively low rate of change), a single point glucose monitor reading can be taken for a reliable calibration. In some additional embodiments, the microprocessor can prompt the user via the user interface to obtain a single point glucose value for calibration at predetermined intervals. In some additional embodiments, the user interface can prompt the user to obtain a single point glucose monitor value for calibration based upon certain events, such as meals, exercise, large excursions in glucose levels, faulty or interrupted data readings, or the like. In some embodiments, certain acceptability parameters can be set for reference values received from the single point glucose monitor. For example, in one embodiment, the receiver only accepts reference glucose data between about 40 and about 400 mg/dL.
At block 204, a data matching module, matches reference data (for example, one or more reference glucose data points) with substantially time corresponding sensor data (for example, one or more sensor data points) to provide one or more matched data pairs. In one embodiment, one reference data point is matched to one time corresponding sensor data point to form a matched data pair. In another embodiment, a plurality of reference data points are averaged (for example, equally or non-equally weighted average, mean-value, median, or the like) and matched to one time corresponding sensor data point to form a matched data pair. In another embodiment, one reference data point is matched to a plurality of time corresponding sensor data points averaged to form a matched data pair. In yet another embodiment, a plurality of reference data points are averaged and matched to a plurality of time corresponding sensor data points averaged to form a matched data pair.
In one embodiment, time corresponding sensor data comprises one or more sensor data points that occur, for example, 15±5 min after the reference glucose data timestamp (for example, the time that the reference glucose data is obtained). In this embodiment, the 15 minute time delay has been chosen to account for an approximately 10 minute delay introduced by the filter used in data smoothing and an approximately 5 minute physiological time-lag (for example, the time necessary for the glucose to diffusion through a membrane(s) of a glucose sensor). In alternative embodiments, the time corresponding sensor value can be more or less than in the above-described embodiment, for example ±60 minutes. Variability in time correspondence of sensor and reference data can be attributed to, for example, a longer or shorter time delay introduced during signal estimation, or if the configuration of the glucose sensor 10 incurs a greater or lesser physiological time lag.
One advantage of integrated receiver of the preferred embodiments can be seen in the time stamp of the reference glucose data. Namely, typical implementations of the continuous glucose sensor 10, wherein the single point glucose monitor is not integral with the receiver, the reference glucose data can be obtained at a time that is different from the time that the data is input into the receiver 30. Thus, the user may not accurately input the “time stamp” of the reference glucose (for example, the time at which the reference glucose value was actually obtained) at the time of reference data input into the receiver. Therefore, the accuracy of the calibration is subject to human error (for example, due to inconsistencies in entering the actual time of the single point glucose test). In contrast, the preferred embodiments of the integrated receiver advantageously do no suffer from this potential inaccuracy in that the time stamp is automatically and accurately obtained at the time of single point glucose test. Additionally, the process of obtaining reference data is simplified and made convenient using the integrated receiver because of fewer loose parts (for example, cables, test strips, or the like) and less required data entry (for example, time of testing).
In some embodiments, tests are used to evaluate the best-matched pair using a reference data point against individual sensor values over a predetermined time period (for example, about 30 minutes). In one such embodiment, the reference data point is matched with sensor data points at 5-minute intervals and each matched pair is evaluated. The matched pair with the best correlation can be selected as the matched pair for data processing. In some alternative embodiments, matching a reference data point with an average of a plurality of sensor data points over a predetermined time period can be used to form a matched pair.
At block 206, 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 glucose data and the sensor glucose data, such as described in more detail with reference to block 208, below.
The matched data pairs, which make up the initial calibration set, can be selected according to predetermined criteria. In some embodiments, the number (n) of data pair(s) selected for the initial calibration set is one. In other embodiments, n data pairs are selected for the initial calibration set wherein n is a function of the frequency of the received reference glucose data points. In one exemplary embodiment, six data pairs make up the initial calibration set. In another embodiment, the calibration set includes only one data pair.
In some embodiments, the data pairs are selected only within a certain glucose value threshold, for example wherein the reference glucose value is between about 40 and about 400 mg/dL. In some embodiments, the data pairs that form the initial calibration set are selected according to their time stamp.
At block 208, a conversion function module creates a conversion function using the calibration set. The conversion function substantially defines the relationship between the reference glucose data and the sensor glucose data. A variety of known methods can be used with the preferred embodiments to create the conversion function from the calibration set. In one embodiment, wherein a plurality of matched data points form the initial calibration set, a linear least squares regression is performed on the initial calibration set such as described in more detail with reference to
At block 210, a sensor data transformation module uses the conversion function to transform sensor data into substantially real-time glucose value estimates, also referred to as calibrated data, as sensor data is continuously (or intermittently) received from the sensor. In other words, the offset value at any given point in time can be subtracted from the raw value (for example, in counts) and divided by the slope to obtain the estimated glucose value:
In some alternative embodiments, the sensor and/or reference glucose data are stored in a database for retrospective analysis.
At block 212, an output module provides output to the user via the user interface. The output is representative of the estimated glucose value, which is determined by converting the sensor data into a meaningful glucose value such as described in more detail with reference to block 210, above. User output can be in the form of a numeric estimated glucose value, an indication of directional trend of glucose concentration, and/or a graphical representation of the estimated glucose data over a period of time, for example. Other representations of the estimated glucose values are also possible, for example audio and tactile.
In one embodiment, the estimated glucose value is represented by a numeric value. In other exemplary embodiments, the user interface graphically represents the estimated glucose data trend over a predetermined time period (for example, one, three, and nine hours, respectively). In alternative embodiments, other time periods can be represented. In alternative embodiments, pictures, animation, charts, graphs, and numeric data can be selectively displayed.
Accordingly, after initial calibration of the sensor, real-time continuous glucose information can be displayed on the user interface so that the user can regularly and proactively care for his/her diabetic condition within the bounds set by his/her physician. Both the calibrated reference glucose data from the single point glucose monitor and the sensor glucose data from the continuous glucose sensor can be displayed to the user. In an embodiment wherein the continuous glucose sensor functions as an adjunctive device to the single point glucose monitor, the user interface can display numeric reference glucose data, while showing the sensor glucose data only in a graphical representation so that the user can see the historical and present sensor trend information as well as the most recent reference glucose data value. In an embodiment wherein the continuous glucose sensor functions as a non-adjunctive device to the single point glucose monitor, the user interface can display the reference glucose data and/or the sensor glucose data. The user can toggle through menus and screens using the buttons in order to view alternate data and/or screen formats, for example.
In alternative embodiments, the conversion function is used to predict glucose values at future points in time. These predicted values can be used to alert the user of upcoming hypoglycemic or hyperglycemic events. Additionally, predicted values can be used to compensate for the time lag (for example, 15 minute time lag such as described elsewhere herein), so that an estimated glucose value displayed to the user represents the instant time, rather than a time delayed estimated value.
In some embodiments, the substantially real-time estimated glucose value, a predicted future estimated glucose value, a rate of change, and/or a directional trend of the glucose concentration is used to control the administration of a constituent to the user, including an appropriate amount and time, in order to control an aspect of the user's biological system. One such example is a closed loop glucose sensor and insulin pump, wherein the glucose data (for example, estimated glucose value, rate of change, and/or directional trend) from the glucose sensor is used to determine the amount of insulin, and time of administration, that can be given to a diabetic user to evade hyper- and hypoglycemic conditions.
In alternative embodiments, other algorithms could be used to determine the conversion function, for example forms of linear and non-linear regression, for example fuzzy logic, neural networks, piece-wise linear regression, polynomial fit, genetic algorithms, and other pattern recognition and signal estimation techniques.
In yet other alternative embodiments, the conversion function can comprise two or more different optimal conversions because an optimal conversion at any time is dependent on one or more parameters, such as time of day, calories consumed, exercise, or glucose concentration above or below a set threshold, for example. In one such exemplary embodiment, the conversion function is adapted for the estimated glucose concentration (for example, high vs. low). For example in an implantable glucose sensor it has been observed that the cells surrounding the implant will consume at least a small amount of glucose as it diffuses toward the glucose sensor. Assuming the cells consume substantially the same amount of glucose whether the glucose concentration is low or high, this phenomenon will have a greater effect on the concentration of glucose during low blood sugar episodes than the effect on the concentration of glucose during relatively higher blood sugar episodes. Accordingly, the conversion function can be adapted to compensate for the sensitivity differences in blood sugar level. In one implementation, the conversion function comprises two different regression lines, wherein a first regression line is applied when the estimated glucose concentration is at or below a certain threshold (for example, 150 mg/dL) and a second regression line is applied when the estimated glucose concentration is at or above a certain threshold (for example, 150 mg/dL). In one alternative implementation, a predetermined pivot of the regression line that forms the conversion function can be applied when the estimated blood is above or below a set threshold (for example, 150 mg/dL), wherein the pivot and threshold are determined from a retrospective analysis of the performance of a conversion function and its performance at a range of glucose concentrations. In another implementation, the regression line that forms the conversion function is pivoted about a point in order to comply with clinical acceptability standards (for example, Clarke Error Grid, Consensus Grid, mean absolute relative difference, or other clinical cost function) and/or physiological parameters. Although only a few example implementations are described, other embodiments include numerous implementations wherein the conversion function is adaptively applied based on one or more parameters that can affect the sensitivity of the sensor data over time.
The preferred embodiments described a continuous glucose sensor and integrated receiver with single point glucose calibration that is more cost effective than conventional reference glucose monitors (for example, more cost effective than test strips). Additionally, the consistency between the similar measurement technologies used both for the continuous sensor and the single point glucose monitor increases the consistency and decreases the cause for error between the two measurements devices, yielding a more reliable, accurate device.
In some alternative embodiments similarly advantageous results can be provided that by combined continuous glucose sensor and integrated receiver configurations wherein the measurement technologies are consistent between the continuous glucose sensor and single point glucose monitor. For example, an optical, non-invasive, “continuous or quasi-continuous” glucose measurement device such as described by U.S. Pat. No. 6,049,727, which is incorporated by reference herein in its entirety, can be implanted in the body. An integrated receiver can be provided that processes sensor data and includes an optical non-invasive single point glucose monitor such as described with reference to U.S. Pat. No. 6,309,884, which is incorporated by reference herein in its entirety. Accordingly, when optical-based technology is used both for the continuous sensor and the single point glucose monitor, increased consistency and decreased cause for error between the two measurements devices exist, yielding a more reliable, accurate device. Other embodiments can be provided that utilize consistent measurement technologies between a continuous analyte sensor and a single point analyte monitor useful for calibration such as described herein and are within the spirit of the preferred embodiments.
Methods and devices that are suitable for use in conjunction with aspects of the preferred embodiments are disclosed in U.S. patent application Ser. No. 10/885,476 filed Jul. 6, 2004, and entitled “SYSTEMS AND METHODS FOR MANUFACTURE OF AN ANALYTE-MEASURING DEVICE INCLUDING A MEMBRANE SYSTEM”; U.S. patent application Ser. No. 10/842,716, filed May 10, 2004, and entitled, “MEMBRANE SYSTEMS INCORPORATING BIOACTIVE AGENTS”; U.S. patent application Ser. No. 10/838,912 filed May 3, 2004, and entitled, “IMPLANTABLE ANALYTE SENSOR”; U.S. patent application Ser. No. 10/789,359 filed Feb. 26, 2004, and entitled, “INTEGRATED DELIVERY DEVICE FOR A CONTINUOUS GLUCOSE SENSOR”; U.S. application Ser. No. 10/685,636 filed Oct. 28, 2003, and entitled, “SILICONE COMPOSITION FOR MEMBRANE SYSTEM”; U.S. application Ser. No. 10/648,849 filed Aug. 22, 2003, and entitled, “SYSTEMS AND METHODS FOR REPLACING SIGNAL ARTIFACTS IN A GLUCOSE SENSOR DATA STREAM”; U.S. application Ser. No. 10/646,333 filed Aug. 22, 2003, entitled, “OPTIMIZED SENSOR GEOMETRY FOR AN IMPLANTABLE GLUCOSE SENSOR”; U.S. application Ser. No. 10/647,065 filed Aug. 22, 2003, entitled, “POROUS MEMBRANES FOR USE WITH IMPLANTABLE DEVICES”; U.S. application Ser. No. 10/633,367 filed Aug. 1, 2003, entitled, “SYSTEM AND METHODS FOR PROCESSING ANALYTE SENSOR DATA”; U.S. Pat. No. 6,702,857 entitled “MEMBRANE FOR USE WITH IMPLANTABLE DEVICES”; U.S. application Ser. No. 09/916,711 filed Jul. 27, 2001, and entitled “SENSOR HEAD FOR USE WITH IMPLANTABLE DEVICE”; U.S. application Ser. No. 09/447,227 filed Nov. 22, 1999, and entitled “DEVICE AND METHOD FOR DETERMINING ANALYTE LEVELS”; U.S. application Ser. No. 10/153,356 filed May 22, 2002, and entitled “TECHNIQUES TO IMPROVE POLYURETHANE MEMBRANES FOR IMPLANTABLE GLUCOSE SENSORS”; U.S. application Ser. No. 09/489,588 filed Jan. 21, 2000, and entitled “DEVICE AND METHOD FOR DETERMINING ANALYTE LEVELS”; U.S. application Ser. No. 09/636,369 filed Aug. 11, 2000, and entitled “SYSTEMS AND METHODS FOR REMOTE MONITORING AND MODULATION OF MEDICAL DEVICES”; and U.S. application Ser. No. 09/916,858 filed Jul. 27, 2001, and entitled “DEVICE AND METHOD FOR DETERMINING ANALYTE LEVELS,” as well as issued patents including U.S. Pat. No. 6,001,067 issued Dec. 14, 1999, and entitled “DEVICE AND METHOD FOR DETERMINING ANALYTE LEVELS”; U.S. Pat. No. 4,994,167 issued Feb. 19, 1991, and entitled “BIOLOGICAL FLUID MEASURING DEVICE”; and U.S. Pat. No. 4,757,022 filed Jul. 12, 1988, and entitled “BIOLOGICAL FLUID MEASURING DEVICE”; U.S. Appl. No. 60/489,615 filed Jul. 23, 2003, and entitled “ROLLED ELECTRODE ARRAY AND ITS METHOD FOR MANUFACTURE”; U.S. Appl. No. 60/490,010 filed Jul. 25, 2003, and entitled “INCREASING BIAS FOR OXYGEN PRODUCTION IN AN ELECTRODE ASSEMBLY”; U.S. Appl. No. 60/490,009 filed Jul. 25, 2003, and entitled “OXYGEN ENHANCING ENZYME MEMBRANE FOR ELECTROCHEMICAL SENSORS”; U.S. application Ser. No. 10/896,312 filed Jul. 21, 2004, and entitled “OXYGEN-GENERATING ELECTRODE FOR USE IN ELECTROCHEMICAL SENSORS”; U.S. application Ser. No. 10/896,637 filed Jul. 21, 2004, and entitled “ROLLED ELECTRODE ARRAY AND ITS METHOD FOR MANUFACTURE”; U.S. application Ser. No. 10/896,772 filed Jul. 21, 2004, and entitled “INCREASING BIAS FOR OXYGEN PRODUCTION IN AN ELECTRODE ASSEMBLY”; U.S. application Ser. No. 10/896,639 filed Jul. 21, 2004, and entitled “OXYGEN ENHANCING ENZYME MEMBRANE FOR ELECTROCHEMICAL SENSORS”; U.S. application Ser. No. 10/897,377 filed Jul. 21, 2004, and entitled “ELECTROCHEMICAL SENSORS INCLUDING ELECTRODE SYSTEMS WITH INCREASED OXYGEN GENERATION”. The foregoing patent applications and patents are incorporated herein by reference in their entireties.
All references cited herein are incorporated herein by reference in their entireties. To the extent publications and patents or patent applications incorporated by reference contradict the disclosure contained in the specification, the specification is intended to supersede and/or take precedence over any such contradictory material.
The term “comprising” as used herein is synonymous with “including,” “containing,” or “characterized by,” and is inclusive or open-ended and does not exclude additional, unrecited elements or method steps.
All numbers expressing quantities of ingredients, reaction conditions, and so forth used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by the present invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should be construed in light of the number of significant digits and ordinary rounding approaches.
The above description discloses several methods and materials of the present invention. This invention is susceptible to modifications in the methods and materials, as well as alterations in the fabrication methods and equipment. Such modifications will become apparent to those skilled in the art from a consideration of this disclosure or practice of the invention disclosed herein. Consequently, it is not intended that this invention be limited to the specific embodiments disclosed herein, but that it cover all modifications and alternatives coming within the true scope and spirit of the invention as embodied in the attached claims.
Any and all priority claims identified in the Application Data Sheet, or any correction thereto, are hereby incorporated by reference under 37 CFR 1.57. This application is a continuation of U.S. application Ser. No. 12/731,965, filed Mar. 25, 2010, which is a continuation of U.S. application Ser. No. 12/182,073, filed Jul. 29, 2008, now abandoned, which is a continuation of U.S. application Ser. No. 10/991,966, filed Nov. 17, 2004, now U.S. Pat. No. 7,519,408, which claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 60/523,840, filed Nov. 19, 2003, U.S. Provisional Application 60/587,787, filed Jul. 13, 2004, and U.S. Provisional Application No. 60/614,683, filed Sep. 30, 2004, Each of the aforementioned applications is incorporated by reference herein in its entirety, and each is hereby expressly made a part of this specification.
| Number | Name | Date | Kind |
|---|---|---|---|
| 2719797 | Rosenblatt et al. | Oct 1955 | A |
| 3210578 | Sherer | Oct 1965 | A |
| 3219533 | Mullins | Nov 1965 | A |
| 3381371 | Russell | May 1968 | A |
| 3775182 | Patton et al. | Nov 1973 | A |
| 3780727 | King | Dec 1973 | A |
| 3826244 | Salcman et al. | Jul 1974 | A |
| 3837339 | Aisenberg et al. | Sep 1974 | A |
| 3898984 | Mandel et al. | Aug 1975 | A |
| 3929971 | Roy | Dec 1975 | A |
| 3943918 | Lewis | Mar 1976 | A |
| 3957613 | Macur | May 1976 | A |
| 3964974 | Banauch et al. | Jun 1976 | A |
| 3979274 | Newman | Sep 1976 | A |
| 4024312 | Korpman | May 1977 | A |
| 4040908 | Clark, Jr. | Aug 1977 | A |
| 4052754 | Homsy | Oct 1977 | A |
| 4073713 | Newman | Feb 1978 | A |
| 4076656 | White et al. | Feb 1978 | A |
| 4172770 | Semersky et al. | Oct 1979 | A |
| 4197840 | Beck et al. | Apr 1980 | A |
| 4215703 | Willson | Aug 1980 | A |
| 4240438 | Updike et al. | Dec 1980 | A |
| 4240889 | Yoda et al. | Dec 1980 | A |
| 4245634 | Albisser et al. | Jan 1981 | A |
| 4253469 | Aslan | Mar 1981 | A |
| 4255500 | Hooke | Mar 1981 | A |
| 4259540 | Sabia | Mar 1981 | A |
| 4374013 | Enfors | Feb 1983 | A |
| 4388166 | Suzuki et al. | Jun 1983 | A |
| 4403984 | Ash et al. | Sep 1983 | A |
| 4415666 | D'Orazio et al. | Nov 1983 | A |
| 4431004 | Bessman et al. | Feb 1984 | A |
| 4436094 | Cerami | Mar 1984 | A |
| 4442841 | Uehara et al. | Apr 1984 | A |
| 4454295 | Wittmann et al. | Jun 1984 | A |
| 4477314 | Richter et al. | Oct 1984 | A |
| 4494950 | Fischell | Jan 1985 | A |
| 4506680 | Stokes | Mar 1985 | A |
| RE31916 | Oswin et al. | Jun 1985 | E |
| 4535786 | Kater | Aug 1985 | A |
| 4554927 | Fussell | Nov 1985 | A |
| 4577642 | Stokes | Mar 1986 | A |
| 4583976 | Ferguson | Apr 1986 | A |
| RE32361 | Duggan | Feb 1987 | E |
| 4655880 | Liu | Apr 1987 | A |
| 4663824 | Kenmochi | May 1987 | A |
| 4671288 | Gough | Jun 1987 | A |
| 4680268 | Clark, Jr. | Jul 1987 | A |
| 4703756 | Gough et al. | Nov 1987 | A |
| 4711251 | Stokes | Dec 1987 | A |
| 4721677 | Clark, Jr. | Jan 1988 | A |
| 4731726 | Allen, III | Mar 1988 | A |
| 4750496 | Reinhart et al. | Jun 1988 | A |
| 4753652 | Langer et al. | Jun 1988 | A |
| 4757022 | Shults et al. | Jul 1988 | A |
| 4759828 | Young et al. | Jul 1988 | A |
| 4781798 | Gough | Nov 1988 | A |
| 4787398 | Garcia et al. | Nov 1988 | A |
| 4805624 | Yao et al. | Feb 1989 | A |
| 4805625 | Wyler | Feb 1989 | A |
| 4807632 | Liess et al. | Feb 1989 | A |
| 4810470 | Burkhardt et al. | Mar 1989 | A |
| 4831070 | McInally et al. | May 1989 | A |
| 4832034 | Pizziconi et al. | May 1989 | A |
| 4841974 | Gumbrecht et al. | Jun 1989 | A |
| 4849458 | Reed et al. | Jul 1989 | A |
| 4852573 | Kennedy | Aug 1989 | A |
| 4858615 | Meinema | Aug 1989 | A |
| 4871440 | Nagata et al. | Oct 1989 | A |
| 4883057 | Broderick | Nov 1989 | A |
| 4889744 | Quaid | Dec 1989 | A |
| 4890620 | Gough | Jan 1990 | A |
| 4890621 | Hakky | Jan 1990 | A |
| 4902294 | Gosserez | Feb 1990 | A |
| 4907857 | Giuliani et al. | Mar 1990 | A |
| 4919141 | Zier et al. | Apr 1990 | A |
| 4927407 | Dorman | May 1990 | A |
| 4927516 | Yamaguchi et al. | May 1990 | A |
| 4944299 | Silvian | Jul 1990 | A |
| 4953552 | DeMarzo | Sep 1990 | A |
| 4974592 | Branco | Dec 1990 | A |
| 4974929 | Curry | Dec 1990 | A |
| 4975636 | Desautels | Dec 1990 | A |
| 4984929 | Rock et al. | Jan 1991 | A |
| 4986671 | Sun et al. | Jan 1991 | A |
| 4988341 | Columbus et al. | Jan 1991 | A |
| 4992794 | Brouwers | Feb 1991 | A |
| 4994167 | Shults et al. | Feb 1991 | A |
| 5002572 | Picha | Mar 1991 | A |
| 5007929 | Quaid | Apr 1991 | A |
| 5030333 | Clark, Jr. | Jul 1991 | A |
| 5034112 | Murase et al. | Jul 1991 | A |
| 5050612 | Matsumura | Sep 1991 | A |
| 5059654 | Hou et al. | Oct 1991 | A |
| 5067491 | Taylor, II et al. | Nov 1991 | A |
| 5068536 | Rosenthal | Nov 1991 | A |
| 5077476 | Rosenthal | Dec 1991 | A |
| 5097834 | Skrabal | Mar 1992 | A |
| 5101814 | Palti | Apr 1992 | A |
| 5108819 | Heller et al. | Apr 1992 | A |
| 5137028 | Nishimura | Aug 1992 | A |
| 5140985 | Schroeder et al. | Aug 1992 | A |
| 5160418 | Mullen | Nov 1992 | A |
| 5165407 | Wilson et al. | Nov 1992 | A |
| 5190041 | Palti | Mar 1993 | A |
| 5198771 | Fidler et al. | Mar 1993 | A |
| 5208147 | Kagenow et al. | May 1993 | A |
| 5235003 | Ward et al. | Aug 1993 | A |
| 5243983 | Tarr et al. | Sep 1993 | A |
| 5249576 | Goldberger et al. | Oct 1993 | A |
| 5262305 | Heller et al. | Nov 1993 | A |
| 5264104 | Gregg et al. | Nov 1993 | A |
| 5266179 | Nankai et al. | Nov 1993 | A |
| 5269891 | Colin | Dec 1993 | A |
| 5271736 | Picha | Dec 1993 | A |
| 5279294 | Anderson et al. | Jan 1994 | A |
| 5281319 | Kaneko et al. | Jan 1994 | A |
| 5282848 | Schmitt | Feb 1994 | A |
| 5284140 | Allen et al. | Feb 1994 | A |
| 5284570 | Savage et al. | Feb 1994 | A |
| 5285513 | Kaufman et al. | Feb 1994 | A |
| 5287753 | Routh et al. | Feb 1994 | A |
| 5299571 | Mastrototaro | Apr 1994 | A |
| 5304468 | Phillips et al. | Apr 1994 | A |
| 5307263 | Brown | Apr 1994 | A |
| 5310469 | Cunningham | May 1994 | A |
| 5312361 | Zadini et al. | May 1994 | A |
| 5314471 | Brauker et al. | May 1994 | A |
| 5316008 | Suga et al. | May 1994 | A |
| 5322063 | Allen et al. | Jun 1994 | A |
| 5324322 | Grill, Jr. et al. | Jun 1994 | A |
| 5326356 | Della Valle et al. | Jul 1994 | A |
| 5330521 | Cohen | Jul 1994 | A |
| 5330634 | Wong et al. | Jul 1994 | A |
| 5331555 | Hashimoto et al. | Jul 1994 | A |
| 5337747 | Neftel | Aug 1994 | A |
| 5342409 | Mullett | Aug 1994 | A |
| 5343869 | Pross et al. | Sep 1994 | A |
| 5344454 | Clarke et al. | Sep 1994 | A |
| 5348788 | White | Sep 1994 | A |
| 5352351 | White et al. | Oct 1994 | A |
| 5354449 | Band et al. | Oct 1994 | A |
| 5356786 | Heller et al. | Oct 1994 | A |
| 5368224 | Richardson et al. | Nov 1994 | A |
| 5372133 | Hogen Esch | Dec 1994 | A |
| 5376070 | Purvis et al. | Dec 1994 | A |
| 5380536 | Hubbell et al. | Jan 1995 | A |
| 5384028 | Ito | Jan 1995 | A |
| 5390671 | Lord et al. | Feb 1995 | A |
| 5391250 | Cheney, II et al. | Feb 1995 | A |
| 5397848 | Yang et al. | Mar 1995 | A |
| 5411647 | Johnson et al. | May 1995 | A |
| 5411866 | Luong et al. | May 1995 | A |
| 5421923 | Clarke et al. | Jun 1995 | A |
| 5426032 | Phillips et al. | Jun 1995 | A |
| 5429735 | Johnson et al. | Jul 1995 | A |
| 5431160 | Wilkins | Jul 1995 | A |
| 5434412 | Sodickson et al. | Jul 1995 | A |
| 5448992 | Kupershmidt | Sep 1995 | A |
| 5453278 | Chan et al. | Sep 1995 | A |
| 5462051 | Oka et al. | Oct 1995 | A |
| 5462064 | DAngelo et al. | Oct 1995 | A |
| 5466356 | Schneider et al. | Nov 1995 | A |
| 5469846 | Khan | Nov 1995 | A |
| 5474552 | Palti | Dec 1995 | A |
| 5476776 | Wilkins | Dec 1995 | A |
| 5482008 | Stafford et al. | Jan 1996 | A |
| 5482473 | Lord et al. | Jan 1996 | A |
| 5484404 | Schulman et al. | Jan 1996 | A |
| 5491474 | Suni et al. | Feb 1996 | A |
| 5494562 | Maley et al. | Feb 1996 | A |
| 5496453 | Uenoyama et al. | Mar 1996 | A |
| 5497772 | Schulman et al. | Mar 1996 | A |
| 5502396 | Desarzens et al. | Mar 1996 | A |
| 5507288 | Booker et al. | Apr 1996 | A |
| 5508203 | Fuller et al. | Apr 1996 | A |
| 5513636 | Palti | May 1996 | A |
| 5518601 | Foos et al. | May 1996 | A |
| 5527288 | Gross et al. | Jun 1996 | A |
| 5531679 | Schulman et al. | Jul 1996 | A |
| 5531878 | Vadgama et al. | Jul 1996 | A |
| 5540828 | Yacynych | Jul 1996 | A |
| 5545220 | Andrews et al. | Aug 1996 | A |
| 5553616 | Ham et al. | Sep 1996 | A |
| 5568806 | Cheney, II et al. | Oct 1996 | A |
| 5569186 | Lord et al. | Oct 1996 | A |
| 5575930 | Tietje-Girault et al. | Nov 1996 | A |
| 5582184 | Erickson et al. | Dec 1996 | A |
| 5584813 | Livingston et al. | Dec 1996 | A |
| 5584876 | Bruchman et al. | Dec 1996 | A |
| 5586553 | Halili et al. | Dec 1996 | A |
| 5589133 | Suzuki | Dec 1996 | A |
| 5590651 | Shaffer et al. | Jan 1997 | A |
| 5593440 | Brauker et al. | Jan 1997 | A |
| 5611900 | Worden et al. | Mar 1997 | A |
| 5628890 | Carter et al. | May 1997 | A |
| 5640470 | Iyer et al. | Jun 1997 | A |
| 5653756 | Clarke et al. | Aug 1997 | A |
| 5653863 | Genshaw et al. | Aug 1997 | A |
| 5660163 | Schulman et al. | Aug 1997 | A |
| 5665065 | Colman et al. | Sep 1997 | A |
| 5676820 | Wang et al. | Oct 1997 | A |
| 5682884 | Hill et al. | Nov 1997 | A |
| 5683562 | Schaffar et al. | Nov 1997 | A |
| 5686829 | Girault | Nov 1997 | A |
| 5695623 | Michel et al. | Dec 1997 | A |
| 5696314 | McCaffrey et al. | Dec 1997 | A |
| 5711861 | Ward et al. | Jan 1998 | A |
| 5714123 | Sohrab | Feb 1998 | A |
| 5730654 | Brown | Mar 1998 | A |
| 5743262 | Lepper, Jr. et al. | Apr 1998 | A |
| 5749832 | Vadgama et al. | May 1998 | A |
| 5749907 | Mann | May 1998 | A |
| 5771890 | Tamada | Jun 1998 | A |
| 5781455 | Hyodo et al. | Jul 1998 | A |
| 5782912 | Brauker et al. | Jul 1998 | A |
| 5787900 | Butler et al. | Aug 1998 | A |
| 5791344 | Schulman et al. | Aug 1998 | A |
| 5795774 | Matsumoto et al. | Aug 1998 | A |
| 5798065 | Picha | Aug 1998 | A |
| 5800420 | Gross et al. | Sep 1998 | A |
| 5800529 | Brauker et al. | Sep 1998 | A |
| 5806517 | Gerhardt et al. | Sep 1998 | A |
| 5807375 | Gross et al. | Sep 1998 | A |
| 5807406 | Brauker et al. | Sep 1998 | A |
| 5811487 | Schulz, Jr. et al. | Sep 1998 | A |
| 5814599 | Mitragotri et al. | Sep 1998 | A |
| 5820622 | Gross et al. | Oct 1998 | A |
| 5822715 | Worthington et al. | Oct 1998 | A |
| 5836887 | Oka et al. | Nov 1998 | A |
| 5836989 | Shelton | Nov 1998 | A |
| 5840148 | Campbell et al. | Nov 1998 | A |
| 5848991 | Gross et al. | Dec 1998 | A |
| 5851197 | Marano et al. | Dec 1998 | A |
| 5861019 | Sun et al. | Jan 1999 | A |
| 5863400 | Drummond et al. | Jan 1999 | A |
| 5871514 | Wiklund et al. | Feb 1999 | A |
| 5882494 | Van Antwerp | Mar 1999 | A |
| 5895235 | Droz | Apr 1999 | A |
| 5897578 | Wiklund et al. | Apr 1999 | A |
| 5899855 | Brown | May 1999 | A |
| 5904708 | Goedeke | May 1999 | A |
| 5913998 | Butler et al. | Jun 1999 | A |
| 5914026 | Blubaugh, Jr. et al. | Jun 1999 | A |
| 5917346 | Gord | Jun 1999 | A |
| 5919215 | Wiklund et al. | Jul 1999 | A |
| 5928155 | Eggers et al. | Jul 1999 | A |
| 5931814 | Alex et al. | Aug 1999 | A |
| 5933136 | Brown | Aug 1999 | A |
| 5944661 | Swette et al. | Aug 1999 | A |
| 5954643 | Vanantwerp et al. | Sep 1999 | A |
| 5954954 | Houck et al. | Sep 1999 | A |
| 5957854 | Besson et al. | Sep 1999 | A |
| 5957903 | Mirzaee et al. | Sep 1999 | A |
| 5961451 | Reber et al. | Oct 1999 | A |
| 5963132 | Yoakum | Oct 1999 | A |
| 5964993 | Blubaugh et al. | Oct 1999 | A |
| 5965380 | Heller et al. | Oct 1999 | A |
| 5971922 | Arita et al. | Oct 1999 | A |
| 5976085 | Kimball et al. | Nov 1999 | A |
| 5995860 | Sun et al. | Nov 1999 | A |
| 5997501 | Gross et al. | Dec 1999 | A |
| 5999848 | Gord et al. | Dec 1999 | A |
| 6001067 | Shults et al. | Dec 1999 | A |
| 6001471 | Bries et al. | Dec 1999 | A |
| 6011984 | Van Antwerp et al. | Jan 2000 | A |
| 6016448 | Busacker et al. | Jan 2000 | A |
| 6023629 | Tamada | Feb 2000 | A |
| 6027445 | Von Bahr | Feb 2000 | A |
| 6036924 | Simons et al. | Mar 2000 | A |
| 6049727 | Crothall | Apr 2000 | A |
| 6059946 | Yukawa et al. | May 2000 | A |
| 6063637 | Arnold et al. | May 2000 | A |
| 6081735 | Diab et al. | Jun 2000 | A |
| 6081736 | Colvin et al. | Jun 2000 | A |
| 6083523 | Dionne et al. | Jul 2000 | A |
| 6083710 | Heller et al. | Jul 2000 | A |
| 6088608 | Schulman et al. | Jul 2000 | A |
| 6091975 | Daddona et al. | Jul 2000 | A |
| 6093156 | Cunningham et al. | Jul 2000 | A |
| 6093172 | Funderburk et al. | Jul 2000 | A |
| 6103033 | Say et al. | Aug 2000 | A |
| 6107083 | Collins et al. | Aug 2000 | A |
| 6115634 | Donders et al. | Sep 2000 | A |
| 6117290 | Say et al. | Sep 2000 | A |
| 6120676 | Heller et al. | Sep 2000 | A |
| 6121009 | Heller et al. | Sep 2000 | A |
| 6122536 | Sun et al. | Sep 2000 | A |
| 6123827 | Wong et al. | Sep 2000 | A |
| 6127154 | Mosbach et al. | Oct 2000 | A |
| 6134461 | Say et al. | Oct 2000 | A |
| 6135978 | Houben et al. | Oct 2000 | A |
| 6142939 | Eppstein et al. | Nov 2000 | A |
| 6144869 | Berner et al. | Nov 2000 | A |
| 6162611 | Heller et al. | Dec 2000 | A |
| 6167614 | Tuttle et al. | Jan 2001 | B1 |
| 6168568 | Gavriely | Jan 2001 | B1 |
| 6169155 | Alvarez et al. | Jan 2001 | B1 |
| 6175752 | Say et al. | Jan 2001 | B1 |
| 6180416 | Kurnik et al. | Jan 2001 | B1 |
| 6187062 | Oweis et al. | Feb 2001 | B1 |
| 6189536 | Martinez et al. | Feb 2001 | B1 |
| 6192891 | Gravel et al. | Feb 2001 | B1 |
| 6201980 | Darrow et al. | Mar 2001 | B1 |
| 6201993 | Kruse et al. | Mar 2001 | B1 |
| 6206856 | Mahurkar | Mar 2001 | B1 |
| 6208894 | Schulman et al. | Mar 2001 | B1 |
| 6212416 | Ward et al. | Apr 2001 | B1 |
| 6212424 | Robinson | Apr 2001 | B1 |
| 6214185 | Offenbacher et al. | Apr 2001 | B1 |
| 6223083 | Rosar | Apr 2001 | B1 |
| 6230059 | Duffin | May 2001 | B1 |
| 6231879 | Li et al. | May 2001 | B1 |
| 6233080 | Brenner et al. | May 2001 | B1 |
| 6233471 | Berner et al. | May 2001 | B1 |
| 6241863 | Monbouquette | Jun 2001 | B1 |
| 6248067 | Causey, III et al. | Jun 2001 | B1 |
| 6256522 | Schultz | Jul 2001 | B1 |
| 6259937 | Schulman et al. | Jul 2001 | B1 |
| 6272364 | Kurnik | Aug 2001 | B1 |
| 6272480 | Tresp et al. | Aug 2001 | B1 |
| 6274285 | Gries et al. | Aug 2001 | B1 |
| 6275717 | Gross et al. | Aug 2001 | B1 |
| 6284478 | Heller et al. | Sep 2001 | B1 |
| 6298254 | Tamada | Oct 2001 | B2 |
| 6299578 | Kurnik et al. | Oct 2001 | B1 |
| 6299583 | Eggers et al. | Oct 2001 | B1 |
| 6300002 | Webb et al. | Oct 2001 | B1 |
| 6302855 | Knobbe et al. | Oct 2001 | B1 |
| 6309351 | Kurnik et al. | Oct 2001 | B1 |
| 6309884 | Cooper et al. | Oct 2001 | B1 |
| 6315738 | Nishikawa et al. | Nov 2001 | B1 |
| 6325978 | Labuda et al. | Dec 2001 | B1 |
| 6326160 | Dunn et al. | Dec 2001 | B1 |
| 6329161 | Heller et al. | Dec 2001 | B1 |
| 6329929 | Weijand et al. | Dec 2001 | B1 |
| 6330464 | Colvin, Jr. et al. | Dec 2001 | B1 |
| 6343225 | Clark, Jr. | Jan 2002 | B1 |
| 6356776 | Berner et al. | Mar 2002 | B1 |
| 6365670 | Fry | Apr 2002 | B1 |
| 6366794 | Moussy et al. | Apr 2002 | B1 |
| 6370941 | Nakamura et al. | Apr 2002 | B2 |
| 6379301 | Worthington et al. | Apr 2002 | B1 |
| 6379317 | Kintzig et al. | Apr 2002 | B1 |
| 6387709 | Mason et al. | May 2002 | B1 |
| 6406066 | Uegane | Jun 2002 | B1 |
| 6406426 | Reuss et al. | Jun 2002 | B1 |
| 6413393 | Van Antwerp et al. | Jul 2002 | B1 |
| 6416651 | Miller | Jul 2002 | B1 |
| 6424847 | Mastrototaro et al. | Jul 2002 | B1 |
| 6447448 | Ishikawa et al. | Sep 2002 | B1 |
| 6447542 | Weadock | Sep 2002 | B1 |
| 6461496 | Feldman et al. | Oct 2002 | B1 |
| 6464849 | Say et al. | Oct 2002 | B1 |
| 6466810 | Ward et al. | Oct 2002 | B1 |
| 6471689 | Joseph et al. | Oct 2002 | B1 |
| 6475750 | Han et al. | Nov 2002 | B1 |
| 6477392 | Honigs et al. | Nov 2002 | B1 |
| 6477395 | Schulman et al. | Nov 2002 | B2 |
| 6481440 | Gielen et al. | Nov 2002 | B2 |
| 6484046 | Say et al. | Nov 2002 | B1 |
| 6494830 | Wessel | Dec 2002 | B1 |
| 6498043 | Schulman et al. | Dec 2002 | B1 |
| 6510329 | Heckel | Jan 2003 | B2 |
| 6512939 | Colvin, Jr. et al. | Jan 2003 | B1 |
| 6520997 | Pekkarinen et al. | Feb 2003 | B1 |
| 6526298 | Khalil et al. | Feb 2003 | B1 |
| 6527729 | Turcott | Mar 2003 | B1 |
| 6534711 | Pollack | Mar 2003 | B1 |
| 6537318 | Ita et al. | Mar 2003 | B1 |
| 6541266 | Modzelewski et al. | Apr 2003 | B2 |
| 6544212 | Galley et al. | Apr 2003 | B2 |
| 6545085 | Kilgour et al. | Apr 2003 | B2 |
| 6546268 | Ishikawa et al. | Apr 2003 | B1 |
| 6546269 | Kurnik | Apr 2003 | B1 |
| 6551496 | Moles et al. | Apr 2003 | B1 |
| 6553241 | Mannheimer et al. | Apr 2003 | B2 |
| 6553244 | Lesho et al. | Apr 2003 | B2 |
| 6558320 | Causey et al. | May 2003 | B1 |
| 6558321 | Burd et al. | May 2003 | B1 |
| 6558351 | Steil et al. | May 2003 | B1 |
| 6560471 | Heller et al. | May 2003 | B1 |
| 6561978 | Conn et al. | May 2003 | B1 |
| 6563244 | Yamauchi et al. | May 2003 | B1 |
| 6565509 | Say et al. | May 2003 | B1 |
| 6569521 | Sheridan et al. | May 2003 | B1 |
| 6572545 | Knobbe et al. | Jun 2003 | B2 |
| 6574490 | Abbink et al. | Jun 2003 | B2 |
| 6575905 | Knobbe et al. | Jun 2003 | B2 |
| 6579498 | Eglise | Jun 2003 | B1 |
| 6579690 | Bonnecaze et al. | Jun 2003 | B1 |
| 6585644 | Lebel et al. | Jul 2003 | B2 |
| 6585763 | Keilman et al. | Jul 2003 | B1 |
| 6589229 | Connelly et al. | Jul 2003 | B1 |
| 6591125 | Buse et al. | Jul 2003 | B1 |
| 6595919 | Berner et al. | Jul 2003 | B2 |
| 6605072 | Struys et al. | Aug 2003 | B2 |
| 6607509 | Bobroff et al. | Aug 2003 | B2 |
| 6607658 | Heller et al. | Aug 2003 | B1 |
| 6612984 | Kerr, II | Sep 2003 | B1 |
| 6613379 | Ward et al. | Sep 2003 | B2 |
| 6618934 | Feldman et al. | Sep 2003 | B1 |
| 6633772 | Ford et al. | Oct 2003 | B2 |
| 6641533 | Causey et al. | Nov 2003 | B2 |
| 6642015 | Vachon et al. | Nov 2003 | B2 |
| 6645181 | Lavi et al. | Nov 2003 | B1 |
| 6648821 | Lebel et al. | Nov 2003 | B2 |
| 6653091 | Dunn et al. | Nov 2003 | B1 |
| 6654625 | Say et al. | Nov 2003 | B1 |
| 6673022 | Bobo et al. | Jan 2004 | B1 |
| 6673596 | Sayler et al. | Jan 2004 | B1 |
| 6683535 | Utke | Jan 2004 | B1 |
| 6687522 | Tamada | Feb 2004 | B2 |
| 6694191 | Starkweather et al. | Feb 2004 | B2 |
| 6695860 | Ward et al. | Feb 2004 | B1 |
| 6699188 | Wessel | Mar 2004 | B2 |
| 6699218 | Flaherty et al. | Mar 2004 | B2 |
| 6699383 | Lemire et al. | Mar 2004 | B2 |
| 6702857 | Brauker et al. | Mar 2004 | B2 |
| 6702972 | Markle | Mar 2004 | B1 |
| 6721587 | Gough | Apr 2004 | B2 |
| 6731976 | Penn et al. | May 2004 | B2 |
| 6740075 | Lebel et al. | May 2004 | B2 |
| 6741877 | Shults et al. | May 2004 | B1 |
| 6742635 | Hirshberg | Jun 2004 | B2 |
| 6743635 | Neel et al. | Jun 2004 | B2 |
| 6773565 | Kunimoto et al. | Aug 2004 | B2 |
| 6802957 | Jung et al. | Oct 2004 | B2 |
| 6809653 | Mann et al. | Oct 2004 | B1 |
| 6810290 | Lebel et al. | Oct 2004 | B2 |
| 6813519 | Lebel et al. | Nov 2004 | B2 |
| 6862465 | Shults et al. | Mar 2005 | B2 |
| 6869413 | Langley et al. | Mar 2005 | B2 |
| 6893552 | Wang et al. | May 2005 | B1 |
| 6895263 | Shin et al. | May 2005 | B2 |
| 6925393 | Kalatz et al. | Aug 2005 | B1 |
| 6931327 | Goode, Jr. et al. | Aug 2005 | B2 |
| 6936006 | Sabra | Aug 2005 | B2 |
| 6952604 | DeNuzzio et al. | Oct 2005 | B2 |
| 6965791 | Hitchcock et al. | Nov 2005 | B1 |
| 6998247 | Monfre et al. | Feb 2006 | B2 |
| 7011630 | Desai et al. | Mar 2006 | B2 |
| 7016713 | Gardner et al. | Mar 2006 | B2 |
| 7022072 | Fox et al. | Apr 2006 | B2 |
| 7025743 | Mann et al. | Apr 2006 | B2 |
| 7027848 | Robinson et al. | Apr 2006 | B2 |
| 7029444 | Shin et al. | Apr 2006 | B2 |
| 7058437 | Buse et al. | Jun 2006 | B2 |
| 7060059 | Keith et al. | Jun 2006 | B2 |
| 7074307 | Simpson et al. | Jul 2006 | B2 |
| 7081195 | Simpson et al. | Jul 2006 | B2 |
| 7098803 | Mann et al. | Aug 2006 | B2 |
| 7108778 | Simpson et al. | Sep 2006 | B2 |
| 7134999 | Brauker et al. | Nov 2006 | B2 |
| 7162290 | Levin | Jan 2007 | B1 |
| 7169289 | Schulein et al. | Jan 2007 | B2 |
| 7183102 | Monfre et al. | Feb 2007 | B2 |
| 7225535 | Feldman et al. | Jun 2007 | B2 |
| 7229288 | Stuart et al. | Jun 2007 | B2 |
| 7261690 | Teller et al. | Aug 2007 | B2 |
| 7267665 | Steil et al. | Sep 2007 | B2 |
| 7276029 | Goode et al. | Oct 2007 | B2 |
| 7278983 | Ireland et al. | Oct 2007 | B2 |
| 7295867 | Berner et al. | Nov 2007 | B2 |
| 7299082 | Feldman et al. | Nov 2007 | B2 |
| 7354420 | Steil et al. | Apr 2008 | B2 |
| 7359723 | Jones | Apr 2008 | B2 |
| 7367942 | Grage et al. | May 2008 | B2 |
| 7399277 | Saidara et al. | Jul 2008 | B2 |
| 7402153 | Steil et al. | Jul 2008 | B2 |
| 7417164 | Suri | Aug 2008 | B2 |
| 7426408 | DeNuzzio et al. | Sep 2008 | B2 |
| 7433727 | Ward et al. | Oct 2008 | B2 |
| 7519408 | Rasdal et al. | Apr 2009 | B2 |
| 7519478 | Bartkowiak et al. | Apr 2009 | B2 |
| 7523004 | Bartkowiak et al. | Apr 2009 | B2 |
| 7583990 | Goode, Jr. et al. | Sep 2009 | B2 |
| 7587287 | Connolly et al. | Sep 2009 | B2 |
| 7591801 | Brauker et al. | Sep 2009 | B2 |
| 7599726 | Goode, Jr. et al. | Oct 2009 | B2 |
| 7604593 | Parris et al. | Oct 2009 | B2 |
| 7618368 | Brown | Nov 2009 | B2 |
| 7618369 | Hayter et al. | Nov 2009 | B2 |
| 7624028 | Brown | Nov 2009 | B1 |
| 7636602 | Baru Fassio et al. | Dec 2009 | B2 |
| 7640032 | Jones | Dec 2009 | B2 |
| 7640048 | Dobbles et al. | Dec 2009 | B2 |
| 7647237 | Malave et al. | Jan 2010 | B2 |
| 7657297 | Simpson et al. | Feb 2010 | B2 |
| 7695434 | Malecha | Apr 2010 | B2 |
| 7711402 | Shults et al. | May 2010 | B2 |
| 7731659 | Malecha | Jun 2010 | B2 |
| 7761126 | Gardner et al. | Jul 2010 | B2 |
| 7766830 | Fox et al. | Aug 2010 | B2 |
| 7771352 | Shults et al. | Aug 2010 | B2 |
| 7774145 | Brauker et al. | Aug 2010 | B2 |
| 7792562 | Shults et al. | Sep 2010 | B2 |
| 7927274 | Rasdal et al. | Apr 2011 | B2 |
| 8005524 | Brauker et al. | Aug 2011 | B2 |
| 8005525 | Goode et al. | Aug 2011 | B2 |
| 8010174 | Goode, Jr. et al. | Aug 2011 | B2 |
| 8282550 | Rasdal et al. | Oct 2012 | B2 |
| 8673598 | Schroder et al. | Mar 2014 | B2 |
| 9538946 | Rasdal et al. | Jan 2017 | B2 |
| 20010016682 | Berner et al. | Aug 2001 | A1 |
| 20010041830 | Varalli et al. | Nov 2001 | A1 |
| 20010051768 | Schulman et al. | Dec 2001 | A1 |
| 20020002326 | Causey, III | Jan 2002 | A1 |
| 20020016535 | Martin et al. | Feb 2002 | A1 |
| 20020019022 | Dunn et al. | Feb 2002 | A1 |
| 20020022883 | Burg | Feb 2002 | A1 |
| 20020026110 | Parris et al. | Feb 2002 | A1 |
| 20020026111 | Ackerman | Feb 2002 | A1 |
| 20020042090 | Heller et al. | Apr 2002 | A1 |
| 20020042561 | Schulman et al. | Apr 2002 | A1 |
| 20020043471 | Ikeda et al. | Apr 2002 | A1 |
| 20020045808 | Ford et al. | Apr 2002 | A1 |
| 20020065453 | Lesho et al. | May 2002 | A1 |
| 20020068860 | Clark, Jr. | Jun 2002 | A1 |
| 20020084196 | Liamos et al. | Jul 2002 | A1 |
| 20020099282 | Knobbe et al. | Jul 2002 | A1 |
| 20020099997 | Piret | Jul 2002 | A1 |
| 20020111547 | Knobbe et al. | Aug 2002 | A1 |
| 20020119711 | Van Antwerp et al. | Aug 2002 | A1 |
| 20020151796 | Koulik | Oct 2002 | A1 |
| 20020155615 | Novikov et al. | Oct 2002 | A1 |
| 20020161288 | Shin | Oct 2002 | A1 |
| 20020182241 | Borenstein et al. | Dec 2002 | A1 |
| 20020188185 | Sohrab | Dec 2002 | A1 |
| 20020193885 | Legeay et al. | Dec 2002 | A1 |
| 20020198513 | Lebel et al. | Dec 2002 | A1 |
| 20030004432 | Assenheimer | Jan 2003 | A1 |
| 20030006669 | Pei et al. | Jan 2003 | A1 |
| 20030023171 | Sato et al. | Jan 2003 | A1 |
| 20030023317 | Brauker et al. | Jan 2003 | A1 |
| 20030028089 | Galley et al. | Feb 2003 | A1 |
| 20030032874 | Rhodes et al. | Feb 2003 | A1 |
| 20030050537 | Wessel | Mar 2003 | A1 |
| 20030050546 | Desai et al. | Mar 2003 | A1 |
| 20030054428 | Monfre et al. | Mar 2003 | A1 |
| 20030060765 | Campbell et al. | Mar 2003 | A1 |
| 20030070548 | Clausen | Apr 2003 | A1 |
| 20030076082 | Morgan et al. | Apr 2003 | A1 |
| 20030078481 | McIvor et al. | Apr 2003 | A1 |
| 20030078560 | Miller et al. | Apr 2003 | A1 |
| 20030091433 | Tam et al. | May 2003 | A1 |
| 20030097082 | Purdy et al. | May 2003 | A1 |
| 20030100040 | Bonnecaze et al. | May 2003 | A1 |
| 20030100821 | Heller et al. | May 2003 | A1 |
| 20030114836 | Estes | Jun 2003 | A1 |
| 20030117296 | Seely | Jun 2003 | A1 |
| 20030120152 | Omiya | Jun 2003 | A1 |
| 20030125612 | Fox et al. | Jul 2003 | A1 |
| 20030125613 | Enegren et al. | Jul 2003 | A1 |
| 20030130616 | Steil et al. | Jul 2003 | A1 |
| 20030134347 | Heller et al. | Jul 2003 | A1 |
| 20030176183 | Drucker et al. | Sep 2003 | A1 |
| 20030187338 | Say et al. | Oct 2003 | A1 |
| 20030188427 | Say et al. | Oct 2003 | A1 |
| 20030199744 | Buse et al. | Oct 2003 | A1 |
| 20030208113 | Mault et al. | Nov 2003 | A1 |
| 20030211625 | Cohan | Nov 2003 | A1 |
| 20030212317 | Kovatchev et al. | Nov 2003 | A1 |
| 20030212346 | Yuzhakov | Nov 2003 | A1 |
| 20030212347 | Sohrab | Nov 2003 | A1 |
| 20030235817 | Bartkowiak et al. | Dec 2003 | A1 |
| 20040010207 | Flaherty et al. | Jan 2004 | A1 |
| 20040011671 | Shults et al. | Jan 2004 | A1 |
| 20040015063 | DeNuzzio et al. | Jan 2004 | A1 |
| 20040015134 | Lavi et al. | Jan 2004 | A1 |
| 20040024327 | Brodnick | Feb 2004 | A1 |
| 20040030285 | Lavi et al. | Feb 2004 | A1 |
| 20040030294 | Mahurkar | Feb 2004 | A1 |
| 20040039298 | Abreu | Feb 2004 | A1 |
| 20040039406 | Jessen | Feb 2004 | A1 |
| 20040040840 | Mao et al. | Mar 2004 | A1 |
| 20040045879 | Shults et al. | Mar 2004 | A1 |
| 20040068230 | Estes et al. | Apr 2004 | A1 |
| 20040073095 | Causey et al. | Apr 2004 | A1 |
| 20040074785 | Holker et al. | Apr 2004 | A1 |
| 20040078219 | Kaylor | Apr 2004 | A1 |
| 20040106857 | Gough | Jun 2004 | A1 |
| 20040143173 | Reghabi et al. | Jul 2004 | A1 |
| 20040146909 | Duong et al. | Jul 2004 | A1 |
| 20040152187 | Haight et al. | Aug 2004 | A1 |
| 20040152622 | Keith et al. | Aug 2004 | A1 |
| 20040167801 | Say et al. | Aug 2004 | A1 |
| 20040173472 | Jung et al. | Sep 2004 | A1 |
| 20040186362 | Brauker et al. | Sep 2004 | A1 |
| 20040186365 | Jin et al. | Sep 2004 | A1 |
| 20040199059 | Brauker et al. | Oct 2004 | A1 |
| 20040204687 | Morgensen | Oct 2004 | A1 |
| 20040219664 | Heller et al. | Nov 2004 | A1 |
| 20040220517 | Starkweather et al. | Nov 2004 | A1 |
| 20040254433 | Bandis et al. | Dec 2004 | A1 |
| 20050010265 | Baru Fassio et al. | Jan 2005 | A1 |
| 20050020887 | Goldberg | Jan 2005 | A1 |
| 20050026689 | Marks | Feb 2005 | A1 |
| 20050027180 | Goode et al. | Feb 2005 | A1 |
| 20050027181 | Goode et al. | Feb 2005 | A1 |
| 20050027182 | Siddiqui et al. | Feb 2005 | A1 |
| 20050027462 | Goode et al. | Feb 2005 | A1 |
| 20050027463 | Goode et al. | Feb 2005 | A1 |
| 20050031689 | Shults et al. | Feb 2005 | A1 |
| 20050033132 | Shults et al. | Feb 2005 | A1 |
| 20050038332 | Saidara et al. | Feb 2005 | A1 |
| 20050043598 | Goode et al. | Feb 2005 | A1 |
| 20050049472 | Manda et al. | Mar 2005 | A1 |
| 20050049473 | Desai et al. | Mar 2005 | A1 |
| 20050051427 | Brauker et al. | Mar 2005 | A1 |
| 20050051440 | Simpson et al. | Mar 2005 | A1 |
| 20050054909 | Petisce et al. | Mar 2005 | A1 |
| 20050056552 | Simpson et al. | Mar 2005 | A1 |
| 20050090607 | Tapsak et al. | Apr 2005 | A1 |
| 20050096519 | DeNuzzio et al. | May 2005 | A1 |
| 20050101847 | Routt et al. | May 2005 | A1 |
| 20050112169 | Brauker et al. | May 2005 | A1 |
| 20050113653 | Fox et al. | May 2005 | A1 |
| 20050115832 | Simpson et al. | Jun 2005 | A1 |
| 20050121322 | Say et al. | Jun 2005 | A1 |
| 20050139489 | Davies et al. | Jun 2005 | A1 |
| 20050143635 | Kamath et al. | Jun 2005 | A1 |
| 20050143675 | Neel et al. | Jun 2005 | A1 |
| 20050154271 | Rasdal et al. | Jul 2005 | A1 |
| 20050177398 | Watanabe et al. | Aug 2005 | A1 |
| 20050182451 | Griffin et al. | Aug 2005 | A1 |
| 20050187720 | Goode, Jr. et al. | Aug 2005 | A1 |
| 20050192557 | Brauker et al. | Sep 2005 | A1 |
| 20050203360 | Brauker et al. | Sep 2005 | A1 |
| 20050211571 | Schulein et al. | Sep 2005 | A1 |
| 20050215872 | Berner et al. | Sep 2005 | A1 |
| 20050239154 | Feldman et al. | Oct 2005 | A1 |
| 20050242479 | Petisce et al. | Nov 2005 | A1 |
| 20050245795 | Goode et al. | Nov 2005 | A1 |
| 20050245799 | Brauker et al. | Nov 2005 | A1 |
| 20050261563 | Zhou et al. | Nov 2005 | A1 |
| 20060015020 | Neale et al. | Jan 2006 | A1 |
| 20060015024 | Brister et al. | Jan 2006 | A1 |
| 20060016700 | Brister et al. | Jan 2006 | A1 |
| 20060019327 | Brister et al. | Jan 2006 | A1 |
| 20060020186 | Brister et al. | Jan 2006 | A1 |
| 20060020187 | Brister et al. | Jan 2006 | A1 |
| 20060020188 | Kamath et al. | Jan 2006 | A1 |
| 20060020189 | Brister et al. | Jan 2006 | A1 |
| 20060020190 | Kamath et al. | Jan 2006 | A1 |
| 20060020191 | Brister et al. | Jan 2006 | A1 |
| 20060020192 | Brister et al. | Jan 2006 | A1 |
| 20060036139 | Brister et al. | Feb 2006 | A1 |
| 20060036140 | Brister et al. | Feb 2006 | A1 |
| 20060036141 | Kamath et al. | Feb 2006 | A1 |
| 20060036142 | Brister et al. | Feb 2006 | A1 |
| 20060036143 | Brister et al. | Feb 2006 | A1 |
| 20060036144 | Brister et al. | Feb 2006 | A1 |
| 20060036145 | Brister et al. | Feb 2006 | A1 |
| 20060040402 | Brauker et al. | Feb 2006 | A1 |
| 20060079809 | Goldberger et al. | Apr 2006 | A1 |
| 20060094947 | Kovatchev | May 2006 | A1 |
| 20060100588 | Brunnberg et al. | May 2006 | A1 |
| 20060148096 | Jina | Jul 2006 | A1 |
| 20060183984 | Dobbles et al. | Aug 2006 | A1 |
| 20060183985 | Brister et al. | Aug 2006 | A1 |
| 20060195029 | Shults et al. | Aug 2006 | A1 |
| 20060222566 | Brauker et al. | Oct 2006 | A1 |
| 20060258929 | Goode et al. | Nov 2006 | A1 |
| 20060281985 | Ward et al. | Dec 2006 | A1 |
| 20070016381 | Kamath et al. | Jan 2007 | A1 |
| 20070027385 | Brister et al. | Feb 2007 | A1 |
| 20070032706 | Kamath et al. | Feb 2007 | A1 |
| 20070038044 | Dobbles et al. | Feb 2007 | A1 |
| 20070049873 | Hansen et al. | Mar 2007 | A1 |
| 20070066873 | Kamath et al. | Mar 2007 | A1 |
| 20070203410 | Say et al. | Aug 2007 | A1 |
| 20070203966 | Brauker et al. | Aug 2007 | A1 |
| 20070208244 | Brauker et al. | Sep 2007 | A1 |
| 20070208245 | Brauker et al. | Sep 2007 | A1 |
| 20070208246 | Brauker et al. | Sep 2007 | A1 |
| 20070213610 | Say et al. | Sep 2007 | A1 |
| 20070225579 | Lucassen et al. | Sep 2007 | A1 |
| 20070232876 | Otto et al. | Oct 2007 | A1 |
| 20070235331 | Simpson et al. | Oct 2007 | A1 |
| 20080021666 | Goode et al. | Jan 2008 | A1 |
| 20080033254 | Kamath et al. | Feb 2008 | A1 |
| 20080071157 | Mcgarraugh et al. | Mar 2008 | A1 |
| 20080071158 | Mcgarraugh et al. | Mar 2008 | A1 |
| 20080072663 | Keenan et al. | Mar 2008 | A1 |
| 20080119709 | Wang et al. | May 2008 | A1 |
| 20080154101 | Jain et al. | Jun 2008 | A1 |
| 20080183061 | Goode et al. | Jul 2008 | A1 |
| 20080183399 | Goode et al. | Jul 2008 | A1 |
| 20080187655 | Markle et al. | Aug 2008 | A1 |
| 20080188722 | Markle et al. | Aug 2008 | A1 |
| 20080188725 | Markle et al. | Aug 2008 | A1 |
| 20080188731 | Brister et al. | Aug 2008 | A1 |
| 20080188796 | Steil et al. | Aug 2008 | A1 |
| 20080189051 | Goode et al. | Aug 2008 | A1 |
| 20080193936 | Squirrell | Aug 2008 | A1 |
| 20080194837 | Kim et al. | Aug 2008 | A1 |
| 20080194935 | Brister et al. | Aug 2008 | A1 |
| 20080194936 | Goode, Jr. et al. | Aug 2008 | A1 |
| 20080194937 | Goode et al. | Aug 2008 | A1 |
| 20080195967 | Goode et al. | Aug 2008 | A1 |
| 20080208025 | Shults et al. | Aug 2008 | A1 |
| 20080210557 | Heller et al. | Sep 2008 | A1 |
| 20080214915 | Brister et al. | Sep 2008 | A1 |
| 20080255438 | Saidara et al. | Oct 2008 | A1 |
| 20080262469 | Brister et al. | Oct 2008 | A1 |
| 20080287764 | Rasdal et al. | Nov 2008 | A1 |
| 20080287765 | Rasdal et al. | Nov 2008 | A1 |
| 20080287766 | Rasdal et al. | Nov 2008 | A1 |
| 20080296155 | Shults et al. | Dec 2008 | A1 |
| 20080305009 | Gamsey et al. | Dec 2008 | A1 |
| 20080305506 | Suri | Dec 2008 | A1 |
| 20080306368 | Goode, Jr. et al. | Dec 2008 | A1 |
| 20080306433 | Dobbles et al. | Dec 2008 | A1 |
| 20080306434 | Dobbles et al. | Dec 2008 | A1 |
| 20080306435 | Kamath et al. | Dec 2008 | A1 |
| 20080306444 | Brister et al. | Dec 2008 | A1 |
| 20090005666 | Shin et al. | Jan 2009 | A1 |
| 20090012379 | Goode et al. | Jan 2009 | A1 |
| 20090018418 | Markle et al. | Jan 2009 | A1 |
| 20090018426 | Markle et al. | Jan 2009 | A1 |
| 20090036758 | Brauker et al. | Feb 2009 | A1 |
| 20090043181 | Brauker et al. | Feb 2009 | A1 |
| 20090043182 | Brauker et al. | Feb 2009 | A1 |
| 20090043525 | Brauker et al. | Feb 2009 | A1 |
| 20090043541 | Brauker et al. | Feb 2009 | A1 |
| 20090043542 | Brauker et al. | Feb 2009 | A1 |
| 20090061528 | Suri | Mar 2009 | A1 |
| 20090062635 | Brauker et al. | Mar 2009 | A1 |
| 20090062645 | Fehre et al. | Mar 2009 | A1 |
| 20090076356 | Simpson et al. | Mar 2009 | A1 |
| 20090076360 | Brister et al. | Mar 2009 | A1 |
| 20090076361 | Kamath et al. | Mar 2009 | A1 |
| 20090081803 | Gamsey et al. | Mar 2009 | A1 |
| 20090099434 | Liu et al. | Apr 2009 | A1 |
| 20090124877 | Goode, Jr. et al. | May 2009 | A1 |
| 20090124878 | Goode, Jr. et al. | May 2009 | A1 |
| 20090156924 | Shariati et al. | Jun 2009 | A1 |
| 20090177143 | Markle et al. | Jul 2009 | A1 |
| 20090182217 | Li et al. | Jul 2009 | A1 |
| 20090192366 | Mensinger et al. | Jul 2009 | A1 |
| 20090192380 | Shariati et al. | Jul 2009 | A1 |
| 20090192722 | Shariati et al. | Jul 2009 | A1 |
| 20090192724 | Brauker et al. | Jul 2009 | A1 |
| 20090192745 | Kamath et al. | Jul 2009 | A1 |
| 20090192751 | Kamath et al. | Jul 2009 | A1 |
| 20090203981 | Brauker et al. | Aug 2009 | A1 |
| 20090204341 | Brauker et al. | Aug 2009 | A1 |
| 20090216103 | Brister et al. | Aug 2009 | A1 |
| 20090240120 | Mensinger et al. | Sep 2009 | A1 |
| 20090240128 | Mensinger et al. | Sep 2009 | A1 |
| 20090240193 | Mensinger et al. | Sep 2009 | A1 |
| 20090242399 | Kamath et al. | Oct 2009 | A1 |
| 20090242425 | Kamath et al. | Oct 2009 | A1 |
| 20090247857 | Harper et al. | Oct 2009 | A1 |
| 20090264719 | Markle et al. | Oct 2009 | A1 |
| 20090264856 | Lebel et al. | Oct 2009 | A1 |
| 20090287074 | Shults et al. | Nov 2009 | A1 |
| 20090299155 | Yang et al. | Dec 2009 | A1 |
| 20090299156 | Simpson et al. | Dec 2009 | A1 |
| 20090299162 | Brauker et al. | Dec 2009 | A1 |
| 20090299276 | Brauker et al. | Dec 2009 | A1 |
| 20100010324 | Brauker et al. | Jan 2010 | A1 |
| 20100010331 | Brauker et al. | Jan 2010 | A1 |
| 20100010332 | Brauker et al. | Jan 2010 | A1 |
| 20100016687 | Brauker et al. | Jan 2010 | A1 |
| 20100016698 | Rasdal et al. | Jan 2010 | A1 |
| 20100022855 | Brauker et al. | Jan 2010 | A1 |
| 20100030053 | Goode, Jr. et al. | Feb 2010 | A1 |
| 20100030484 | Brauker et al. | Feb 2010 | A1 |
| 20100030485 | Brauker et al. | Feb 2010 | A1 |
| 20100036215 | Goode, Jr. et al. | Feb 2010 | A1 |
| 20100036216 | Goode, Jr. et al. | Feb 2010 | A1 |
| 20100036222 | Goode, Jr. et al. | Feb 2010 | A1 |
| 20100036223 | Goode, Jr. et al. | Feb 2010 | A1 |
| 20100036224 | Goode, Jr. et al. | Feb 2010 | A1 |
| 20100036225 | Goode, Jr. et al. | Feb 2010 | A1 |
| 20100041971 | Goode, Jr. et al. | Feb 2010 | A1 |
| 20100045465 | Brauker et al. | Feb 2010 | A1 |
| 20100049024 | Saint et al. | Feb 2010 | A1 |
| 20100076283 | Simpson et al. | Mar 2010 | A1 |
| 20100081908 | Dobbles et al. | Apr 2010 | A1 |
| 20100161269 | Kamath et al. | Jun 2010 | A1 |
| 20100174158 | Kamath et al. | Jul 2010 | A1 |
| 20100174167 | Kamath et al. | Jul 2010 | A1 |
| 20100174168 | Goode et al. | Jul 2010 | A1 |
| 20100179399 | Goode et al. | Jul 2010 | A1 |
| 20100179401 | Rasdal et al. | Jul 2010 | A1 |
| 20100179405 | Goode et al. | Jul 2010 | A1 |
| 20100179406 | Goode et al. | Jul 2010 | A1 |
| 20100179407 | Goode, Jr. et al. | Jul 2010 | A1 |
| 20100179408 | Kamath et al. | Jul 2010 | A1 |
| 20100179409 | Kamath et al. | Jul 2010 | A1 |
| 20100185065 | Goode et al. | Jul 2010 | A1 |
| 20100185072 | Goode et al. | Jul 2010 | A1 |
| 20100185073 | Goode et al. | Jul 2010 | A1 |
| 20100185074 | Goode et al. | Jul 2010 | A1 |
| 20100204555 | Shults et al. | Aug 2010 | A1 |
| 20100214104 | Goode et al. | Aug 2010 | A1 |
| 20100217106 | Goode et al. | Aug 2010 | A1 |
| 20100217555 | Goode, Jr. et al. | Aug 2010 | A1 |
| 20100234707 | Goode, Jr. et al. | Sep 2010 | A1 |
| 20100234796 | Kamath et al. | Sep 2010 | A1 |
| 20100235106 | Goode, Jr. et al. | Sep 2010 | A1 |
| 20100240975 | Goode, Jr. et al. | Sep 2010 | A1 |
| 20100240976 | Goode, Jr. et al. | Sep 2010 | A1 |
| 20110118579 | Goode, Jr. et al. | May 2011 | A1 |
| 20110124997 | Goode, Jr. et al. | May 2011 | A1 |
| 20110130970 | Goode, Jr. et al. | Jun 2011 | A1 |
| 20110137601 | Goode, Jr. et al. | Jun 2011 | A1 |
| 20110201910 | Rasdal et al. | Aug 2011 | A1 |
| 20110218414 | Kamath et al. | Sep 2011 | A1 |
| 20110231140 | Goode, Jr. et al. | Sep 2011 | A1 |
| 20110231141 | Goode, Jr. et al. | Sep 2011 | A1 |
| 20110231142 | Goode, Jr. et al. | Sep 2011 | A1 |
| Number | Date | Country |
|---|---|---|
| 2127172 | Jul 1998 | CA |
| 0 098 592 | Jan 1984 | EP |
| 0 107 634 | May 1984 | EP |
| 0 127 958 | Dec 1984 | EP |
| 0 286 118 | Oct 1988 | EP |
| 0 288 793 | Nov 1988 | EP |
| 0 320 109 | Jun 1989 | EP |
| 0 352 610 | Jan 1990 | EP |
| 0 352 631 | Jan 1990 | EP |
| 0 353 328 | Feb 1990 | EP |
| 0 390 390 | Oct 1990 | EP |
| 0396788 | Nov 1990 | EP |
| 0 406 473 | Jan 1991 | EP |
| 0 440 044 | Aug 1991 | EP |
| 0 441 252 | Aug 1991 | EP |
| 0 441 394 | Aug 1991 | EP |
| 0 467 078 | Jan 1992 | EP |
| 0534074 | Mar 1993 | EP |
| 0 563 795 | Oct 1993 | EP |
| 0 323 605 | Jan 1994 | EP |
| 0 647 849 | Apr 1995 | EP |
| 0 424 633 | Jan 1996 | EP |
| 0 776 628 | Jun 1997 | EP |
| 0817809 | Jan 1998 | EP |
| 0 838 230 | Apr 1998 | EP |
| 0 880 936 | Dec 1998 | EP |
| 0 885 932 | Dec 1998 | EP |
| 0967788 | Dec 1999 | EP |
| 0995805 | Apr 2000 | EP |
| 1 077 634 | Feb 2001 | EP |
| 1 078 258 | Feb 2001 | EP |
| 1 153 571 | Nov 2001 | EP |
| 0 817 809 | Jul 2002 | EP |
| 1 266 607 | Dec 2002 | EP |
| 2 226 086 | Aug 2010 | EP |
| 2 223 710 | Sep 2010 | EP |
| 2656423 | Jun 1991 | FR |
| 2760962 | Sep 1998 | FR |
| 1 442 303 | Jul 1976 | GB |
| 2 149 918 | Jun 1985 | GB |
| S6283649 | Apr 1987 | JP |
| S6283849 | Apr 1987 | JP |
| 04-215739 | Aug 1992 | JP |
| H0783871 | Mar 1995 | JP |
| 2002-513602 | May 2002 | JP |
| 2002189015 | Jul 2002 | JP |
| WO 1989002720 | Apr 1989 | WO |
| WO 1990000738 | Jan 1990 | WO |
| WO 1990010861 | Sep 1990 | WO |
| WO 1992013271 | Aug 1992 | WO |
| WO 1993014693 | Aug 1993 | WO |
| WO 1994022367 | Oct 1994 | WO |
| WO 1995007109 | Mar 1995 | WO |
| WO 1995013838 | May 1995 | WO |
| WO 1996014026 | May 1996 | WO |
| WO 1996025089 | Aug 1996 | WO |
| WO 1996030431 | Oct 1996 | WO |
| WO 1997001986 | Jan 1997 | WO |
| WO 1997006727 | Feb 1997 | WO |
| WO 1997028737 | Aug 1997 | WO |
| WO 1998024358 | Jun 1998 | WO |
| WO-9838906 | Sep 1998 | WO |
| WO 1999056613 | Apr 1999 | WO |
| WO 1999048419 | Sep 1999 | WO |
| WO 1999058051 | Nov 1999 | WO |
| WO 1999058973 | Nov 1999 | WO |
| WO 2000012720 | Mar 2000 | WO |
| WO 2000013002 | Mar 2000 | WO |
| WO 2000013003 | Mar 2000 | WO |
| WO 2000019887 | Apr 2000 | WO |
| WO 2000032098 | Jun 2000 | WO |
| WO 2000033065 | Jun 2000 | WO |
| WO 2000049941 | Aug 2000 | WO |
| WO 2000059373 | Oct 2000 | WO |
| WO 2000074753 | Dec 2000 | WO |
| WO 2000078210 | Dec 2000 | WO |
| WO-0112158 | Feb 2001 | WO |
| WO 2001016579 | Mar 2001 | WO |
| WO 2001020019 | Mar 2001 | WO |
| WO 2001020334 | Mar 2001 | WO |
| WO 2001034243 | May 2001 | WO |
| WO 2001052727 | Jul 2001 | WO |
| WO 2001058348 | Aug 2001 | WO |
| WO 2001068901 | Sep 2001 | WO |
| WO 2001069222 | Sep 2001 | WO |
| WO 2001088524 | Nov 2001 | WO |
| WO 2001088534 | Nov 2001 | WO |
| WO 2002005702 | Jan 2002 | WO |
| WO 2002024065 | Mar 2002 | WO |
| WO-0078210 | May 2002 | WO |
| WO 2002082989 | Oct 2002 | WO |
| WO 2002089666 | Nov 2002 | WO |
| WO 2002100266 | Dec 2002 | WO |
| WO 2003000127 | Jan 2003 | WO |
| WO-03063700 | Aug 2003 | WO |
| WO 2003101862 | Dec 2003 | WO |
| WO 2004110256 | Dec 2004 | WO |
| WO 2005011489 | Feb 2005 | WO |
| WO 2005012873 | Feb 2005 | WO |
| WO 2005026689 | Mar 2005 | WO |
| WO 2005032400 | Apr 2005 | WO |
| WO 2005057168 | Jun 2005 | WO |
| WO 2005057175 | Jun 2005 | WO |
| WO 2005078424 | Aug 2005 | WO |
| WO-2005026689 | Oct 2005 | WO |
| WO-2006017358 | Feb 2006 | WO |
| WO 2006050405 | May 2006 | WO |
| WO 2006105146 | Oct 2006 | WO |
| WO 2006118713 | Nov 2006 | WO |
| WO 2006131288 | Dec 2006 | WO |
| WO 2007002579 | Jan 2007 | WO |
| WO 2007065285 | Jun 2007 | WO |
| WO 2007097754 | Aug 2007 | WO |
| WO 2007114943 | Oct 2007 | WO |
| WO 2007127606 | Nov 2007 | WO |
| WO 2007143225 | Dec 2007 | WO |
| WO 2008076868 | Jun 2008 | WO |
| Entry |
|---|
| US 7,530,950 B2, 05/2009, Brister et al. (withdrawn) |
| Abel et al. 1984. Experience with an implantable glucose sensor as a prerequisite of an artificial beta cell. Biomed Biochim Acta 43(5):577-584. |
| Abel et al. 2002. Biosensors for in vivo glucose measurement: can we cross the experimental stage. Biosensors & Bioelectronics 17:1059-1070. |
| Adilman, Glenn, Dec. 1983. Videogames: Knowing the Score, Creative Computing 9:224 (5 pages), Dialog: File 148, Acc# 01891055. |
| Alcock & Turner 1994. Continuous Analyte Monitoring to Aid Clinical Practice. IEEE Engineering in Med & Biol Mag 13:319-325. |
| American Heritage Dictionary, 4th Edition. 2000. Houghton Mifflin Company, p. 82. |
| Amin et al. 2003. Hypoglycemia prevalence in prepubertal children with type 1 diabetes on standard insulin regimen: Use of continuous glucose monitoring system. Diabetes Care 26(3):662-667. |
| Answers.com. 2006. “xenogenic.” The American Heritage Stedman's Medical Dictionary. Houghton Mifflin Company, 2002. Answers.com Nov. 7, 2006 http://www.Answers.com/topic/xenogenic. |
| Armour et al. Dec. 1990. Application of Chronic Intravascular Blood Glucose Sensor in Dogs. Diabetes 39:1519-1526. |
| Atanasov et al. 1994. Biosensor for continuous glucose monitoring. Biotechnology and Bioengineering 43:262-266. |
| Atanasov et al. 1997. Implantation of a refillable glucose monitoring-telemetry device. Biosensors & Bioelectronics 12:669-680. |
| Aussedat et al. 1997. A user-friendly method for calibrating a subcutaneous glucose sensor-based hypoglycaemic alarm. Biosensors & Bioelectronics 12(11): 1061-1071. |
| Bailey et al. 2007. Reduction in hemoglobin A 1 c with real-time continuous glucose monitoring: results from a 12-week observational study. Diabetes Technology & Therapeutics 9(3):203-210. |
| Baker et al. 1996. Dynamic delay and maximal dynamic error in continuous biosensors. Analytical Chemistry 68(8):1292-1297. |
| Bani Amer, M. M. 2002. An accurate amperometric glucose sensor based glucometer with eliminated cross-sensitivity. J Med Eng Technol 26(5):208-213. |
| Bard et al. 1980. Electrochemical Methods. John Wiley & Sons, pp. 173-175. |
| Beach et al. 1999. Subminiature implantable potentiostat and modified commercial telemetry device for remote glucose monitoring. IEEE Transactions on Instrumentation and Measurement 48(6):1239-1245. |
| Bellucci et al. Jan. 1986. Electrochemical behaviour of graphite-epoxy composite materials (GECM) in aqueous salt solutions. J Applied Electrochemistry 16( 1):15-22. |
| Bessman et al. 1973. Progress toward a glucose sensor for the artificial pancreas. Proceedings of a Workshop on Ion-Selective Microelectrodes, Jun. 4-5, 1973, Boston, MA, pp. 189-197. |
| Biermann et al. 2008. How would patients behave if they were continually informed of their blood glucose levels? A simulation study using a “virtual” patient. Diabetes Technology & Therapeutics 10:178-187. |
| Bindra et al. 1991. Design and In Vitro Studies of a Needle-Type Glucose Sensor for Subcutaneous Monitoring. Analytical Chemistry 63: 1692-1696. |
| Bisenberger et al. 1995. A triple-step potential waveform at enzyme multisensors with thick-film gold electrodes for detection of glucose and sucrose. Sensors and Actuators B 28:181-189. |
| Bland et al. 1986. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1:307-310. |
| Bland et al. 1990. A note on the use of the intraclass correlation coefficient in the evaluation of agreement between two methods of measurement. Comput Biol Med 20(5):337-340. |
| Bobbioni-Harsch et al. 1993. Lifespan of subcutaneous glucose sensors and their performances during dynamic glycaemia changes in rats. J Biomed Eng 15:457-463. |
| Bode et al. 1999. Continuous glucose monitoring used to adjust diabetes therapy improves glycosylated hemoglobin: A pilot study. Diabetes Research and Clinical Practice 46:183-190. |
| Bode et al. 2000. Using the continuous glucose monitoring system to improve the management of type 1 diabetes. Diabetes Technology & Therapeutics 2(Suppl 1):S43-S48. |
| Bode, B. W. 2000. Clinical utility of the continuous glucose monitoring system. Diabetes Technology & Therapeutics (Suppl 1):S35-s41. |
| Boedeker Plastics, Inc. 2009. Polyethylene Specifications Data Sheet, http://www.boedeker.com/polye_p.htm [Aug. 19, 2009 3:36:33 PM]. |
| Boland et al. 2001. Limitations of conventional methods of self-monitoring of blood glucose. Diabetes Care 24(11):1858-1862. |
| Bolinder et al. 1992. Microdialysis measurement of the absolute glucose concentration in subcutaneous adipose tissue allowing glucose monitoring in diabetic patients. Diabetologia 35:1177-1180. |
| Bolinder et al. 1997. Self-monitoring of blood glucose in type 1 diabetic patients: Comparison with continuous microdialysis measurements of glucose in subcutaneous adipose tissue during ordinary life conditions. Diabetes Care 20(1):64-70. |
| Bott, A. 1998. Electrochemical methods for the determination of glucose. Current Separations 17(1 ):25-31. |
| Bott, A. W. 1997. A Comparison of Cyclic Voltammetry and Cyclic Staircase Voltammetry. Current Separations 16(1):23-26. |
| Bowman et al. 1986. The packaging of implantable integrated sensors. IEEE Trans Biomed Eng (BME) 33(2):248-255. |
| Brauker et al. Jun. 27, 1996. Local Inflammatory Response Around Diffusion Chambers Containing Xeongrafts. Transplantation 61(12):1671-1677. |
| Braunwald, 2008. Biomarkers in heart farlure. NEJM 358: 2148-2159. |
| Bremer et al. 1999. Is blood glucose predictable from previous values? A solicitation for data. Diabetes 48:445-451. |
| Bremer et al. 2001. Benchmark data from the literature for evaluation of new glucose sensing technologies, Diabetes Technology & Therapeutics 3(3):409-418. |
| Brooks et al. 1987/88. Development of an on-line glucose sensor for fermentation momtoring. Biosensors, 3:45-56 (1987/88). |
| Bruckel et al. 1989. In vivo measurement of subcutaneous glucose concentrations with an enzymatic glucose sensor and a wick method. Klin Wochenschr 67:491-495. |
| Brunstein et al. 1989. Preparation and validation of implantable electrodes for the measurement of oxygen and glucose. Biomed Biochim. Acta 48(11/12):911-917. |
| Cai et al. 2004. A wireless, remote query glucose biosensor based on a pH-sensitive polymer, Analytical Chemistry 76(4):4038-4043. |
| Cameron et al. 1997. Micromodular Implants to provide electrical stimulation of paralyzed muscles and limbs. IEEE Trans Biomed Eng (BME) 44(9):781-790. |
| Campanella et al. 1993. Biosensor for direct determination of glucose and lactate in undiluted biological fluids. Biosensors & Bioelectronics 8:307-314. |
| Candas et al. 1994. An adaptive plasma glucose controller based on a nonlinear insulin/glucose model. . IEEE Trans Biomed Eng (BME) 41(2): 116-124. |
| Cass et al. 1984. Ferrocene-mediated enzyme electrodes for amperometric determination of glucose. Analytical Chemistry 36:667-671. |
| Cassidy et al., Apr. 1993. Novel electrochemical device for the detection of cholesterol or glucose. Analyst 118:415-418. |
| Chase et al. 2001. Continuous subcutaneous glucose monitoring in children with type 1 diabetes. Pediatrics 107:222-226. |
| Chen et al. 2002. Defining the period of recovery of the glucose concentration after its local perturbation by the implantation of a miniature sensor. Clin Chem Lab Med 40:786-789. |
| Chia et al. 2004. Glucose sensors: toward closed loop insulin delivery. Endocrinol Metab Clin North Am 33:175-95. |
| Choleau et al. 2002. Calibration of a subcutaneous amperometric glucose sensor implanted for 7 days in diabetic patients. Part 1. Effect of measurement uncertainties on the determination of sensor sensitivity and background current. Biosensors and Bioelectronics 17:641-646. |
| Choleau et al. 2002. Calibration of a subcutaneous amperometric glucose sensor implanted for 7 days in diabetic patients. Part 2. Superiority of the one-point calibration method. Biosensors and Bioelectronics 17:647-654. |
| Ciba Speciality Chemicals, Incs. 1998. Ciba® Irgacure® 2959 Photoinitiator, Product Description. Apr. 2, 1998, Basel, Switzerland (3 pages). |
| Claremont et al. 1986. Subcutaneous implantation of a ferrocene-mediated glucose sensor in pigs. Diabetologia 29:817-821. |
| Claremont et al. Jul. 1986. Potentially-implantable, ferrocene-mediated glucose sensor. J Biomed Eng 8: 272-274. |
| Clark et al. 1981. One-minute electrochemical enzymic assay for cholesterol in biological materials. Clin Chem 27(12):1978-1982. |
| Clark et al. 1987. Configurational cyclic voltammetry: increasing the specificity and reliability of implanted electrodes. IEEE/Ninth Annual Conference of the Engineering in Medicine and Biology Society, pp. 0782-0783. |
| Clark et al. 1988. Long-term stability of electroenzymatic glucose sensors implanted in mice. Trans Am Soc Artif Intern Organs 34:259-265. |
| Clarke et al. Sep.-Oct. 1987. Evaluating Clinical Accuracy of Systems for Self-Monitoring of Blood Glucose. Diabetes Care 10(5):622-628. |
| CLSI. 2008. Performance metrics for continuous interstitial glucose monitoring; approved guideline, CLSI document POCT05-A. Wayne, PA: Clinical and Laboratory Standards Institute. 28(33) (72 pages). |
| Colangelo et al. 1967. Corrosion rate measurements in vivo. J Biomed Matls Res 1:405-414. |
| Colowick et al. 1976. Methods in Enzymology, vol. XLIV, Immobilized Enzymes. New York: Academic Press (11 pages). |
| Cox et al. 1985. Accuracy of perceiving blood glucose in IDDM. Diabetes Care 8(6):529-536. |
| Csoregi et al. 1994. Amperometric microbiosensors for detection of hydrogen peroxide and glucose based on peroxidase-modified carbon fibers. Electroanalysis 6:925-933. |
| Csoregi et al., 1994. Design, characterization, and one-point in vivo calibration of a subcutaneously implanted glucose electrode. Analytical Chemistry 66(19):3131-3138. |
| Currie et al. 2004. Novel non-intrusive trans-dermal remote wireless micro-fluidic monitoring systme applied to continuous glucose and lactate assays for casualty care and combat readiness assessment. RTO HFM Symposium, St. Pete Beach, RTO-MP-HFM-109, Aug. 16-18, 2004 (18 pages). |
| Danielsson et al. 1988. Enzyme thermistors. Methods in Enzymology 137:181-197. |
| Dassau et al. 2009. In silico evaluation platform for artificial pancreatic (3-cell development—a dynamic simulator for closed loop control with hardware-in-the-loop. Diabetes Technology & Therapeutics 11(3):1-8. |
| Davieset al. 1992. Polymer membranes in clinical sensor applications. I. An overview of membrane function. Biomaterials 13(14):971-978. |
| Davis et al. 1983. Bioelectrochemical fuel cell and sensor based on a quinoprotein, alcohol dehydrogenase. Enzyme Microb Technol 5:383-388. |
| Deutsch et al. 1994. Time series analysis and control of blood glucose levels in diabetic patients. Computer Methods and Programs in Biomedicine 41:167-182. |
| Dixon et al. 2002. Characterization in vitro and in vivo of the oxygen dependence of an enzyme/polymer biosensor for monitoring brain glucose. J Neuroscience Methods 119:135-142. |
| DuPont1 Dimension AR®. 1998. The chemistry analyzer that makes the most of your time, money and effort. Catalog. Dade International, Chemistry Systems. Newark, DE (18 pages). |
| Durliat et al. 1976. Spectrophotometric and electrochemical determinations of L(+)-lactate in blood by use of lactate dehydrogenase from yeast. Clin Chem 22(11): 1802-1805. |
| Edwards Lifesciences. 2002. Accuracy for you and your patients. Marketing materials (4 pages). |
| El Degheidy et al. 1986. Optimization of an implantable coated wire glucose sensor. J Biomed Eng 8:121-129. |
| El-Khatib et al. 2007. Adaptive closed-loop control provides blood-glucose regulation using dual subcutaneous insulin and glucagon infusion in diabetic swine. J Diabetes Science and Technology 1(2):181-192. |
| El-Sa'ad et al. 1990. Moisture Absorption by Epoxy Resins: the Reverse Thermal Effect. J Materials Science 25:3577-3582. |
| Ernst et al. 2002. Reliable glucose monitoring through the use of microsystem technology. Analytical Bioanalytical Chemistry 373:758-761. |
| Fabietti et al. 2007. Clinical validation of a new control-oriented model of insulin and glucose dynamos in subjects with type 1 diabetes. Diabetes Technology & Therapeutics 9(4):327-338. |
| Fahy et al. Mar. 2008. An analysis: hyperglycemic intensive care patients need continuous glucose monitoring—easier said than done. J Diabetes Science and Technology 2(2):201-204. |
| Fare et al. 1998. Functional characterization of a conducting polymer-based immunoassay system. Biosensors & Bioelectronics 13(3-4):459-470. |
| Feldman et al. 2003. A continuous glucose sensor based on wired enzyme technology—results from a 3-day trial in patients with type 1 diabetes. Diabetes Technology & Therapeutics 5(5):769-779. |
| Fischer et al. 1987. Assessment of subcutaneous glucose concentration: validation of the wick technique as a reference for implanted electrochemical sensors in normal and diabetic dogs. Diabetologia 30:940-945. |
| Fischer et al. 1989. Oxygen Tension at the Subcutaneous Implantation Site of Glucose Sensors. Biomed Biochem 11/12:965-972. |
| Fischer et al. 1995. (Abstract) Hypoglycaemia-warning by means of subcutaneous electrochemical glucose sensors: an animal study. Horm Metab Rese 27:53. |
| Freedman et al. 1991. Statistics, Second Edition, W.W. Norton & Company, p. 74. |
| Freiberger, Paul, 1992. Video Game Takes on Diabetes Superhero ‘Captain Novolin’Offers Treatment Tips, San Francisco Examiner, Jun. 26, 1992, Fourth Edition, Business Sec. B1. |
| Frohnauer et al. 2001. Graphical human insulin time-activity profiles using standardized definitions. Diabetes Technology & Therapeutics 3(3):419-429. |
| Frost et al. 2002. Implantable chemical sensors for real-time clinical monitoring: Progress and challenges. Current Opinion in Chemical Biology 6:633-641. |
| Gabbay et al. 2008. Optical coherence tomography-based continuous noninvasive glucose monitoring in patients with diabetes. Diabetes Technology & Therapeutics 10:188-193. |
| Ganesan et al. 2005. Gold layer-based dual crosslinking procedure of glucose oxidase with ferrocene monocarboxylic acid provides a stable biosensor. Analytical Biochemistry 343:188-191. |
| Ganesh et al. Mar. 2008. Evaluation of the VIA® blood chemistry monitor for glucose in healthy and diabetic volunteers, J Diabetes Science and Technology 2(2):182-193. |
| Garg et al. 1999. Correlation of fingerstick blood glucose measurements with GlucoWatch biographer glucose results in young subjects with type 1 diabetes. D iabetes Care 22(10):1708-1714. |
| Garg et al. 2004. Improved Glucose Excursions Using an Implantable Real-Time continuous Glucose Sensor in Adults with Type I Diabetes. Diabetes Care 27:734-738. |
| Gerritsen et al. 1999. Performance of subcutaneously implanted glucose sensors for continuous monitoring. The Netherlands Journal of Medicine 54:167-179. |
| Gerritsen, M. 2000. Problems associated with subcutaneously implanted glucose sensors. Diabetes Care 23(2):143-145. |
| Gilligan et al. 1994. Evaluation of a subcutaneous glucose sensor out to 3 months in a dog model. Diabetes Care 17(8):882-887. |
| Gilligan et al. 2004. Feasibility of continuous long-term glucose monitoring from a subcutaneous glucose sensor in humans. Diabetes Technology & Therapeutics 6:378-386. |
| Godsland et al. 2001. Maximizing the Success Rate of Minimal Model Insulin Sensitivity Measurement in Humans: The Importance of Basal Glucose Levels. Clinical Science 110:1-9. |
| Gouda et al., Jul. 4, 2003. Thermal inactivation of glucose oxidase. The Journal of Biological Chemistry 278(27):24324-24333. |
| Gough 2001. The implantable glucose sensor: An example of bioengineering design. Introduction to Bioengineering, Chapter 3, pp. 57-66. |
| Gough et al. 2000. Immobilized glucose oxidase in implantable glucose sensor technology. Diabetes Technology & Therapeutics 2(3):377-380. |
| Gough et al. 2003. Frequency characterization of blood glucose dynamics. Annals of Biomedical Engineering 31:91-97. |
| Gross et al. 2000. Efficacy and reliability of the continuous glucose monitoring system. Diabetes Technology & Therapeutics 2(Suppl 1):S19-S26. |
| Gross et al. 2000. Performance evaluation of the MiniMed® continuous glucose monitoring system during patient home use. Diabetes Technology & Therapeutics 2(1):49-56. |
| Guerci et al., 2003. Clinical performance of CGMS in type 1 diabetic patients treated by continuous subcutaneous insulin infusion using insulin analogs. Diabetes Care 26:582-589. |
| Hall et al. 1998. Electrochemical oxidation of hydrogen peroxide at platinum electrodes. Part I: An adsorption-controlled mechanism. Electrochimica Acta 43(5-6):579-588. |
| Hall et al. 1998. Electrochemical oxidation of hydrogen peroxide at platinum electrodes. Part II: Effect of potential. Electrochimica Acta 43(14-15):2015-2024. |
| Hall et al. 1999. Electrochemical oxidation of hydrogen peroxide at platinum electrodes. Part III: Effect of temperature. Electrochimica Acta, 44:2455-2462. |
| Hall et al. 1999. Electrochemical oxidation of hydrogen peroxide at platinum electrodes. Part IV: Phosphate buffer dependence. Electrochimica Acta, 44:4573-4582. |
| Hall et al. 2000. Electrochemical oxidation of hydrogen peroxide at platinum electrodes. Part V: Inhibition by chloride. Electrochimica Acta, 45:3573-3579. |
| Hamilton Syringe Selection Guide. 2006. Syringe Selection, www.hamiltoncompany.com. |
| Hashiguchi et al. 1994. Development of a miniaturized glucose monitoring system by combining a needle-type glucose sensor with microdialysis sampling method: Long-term subcutaneous tissue glucose monitoring in ambulatory diabetic patients. Diabetes Care 17(5):387-396. |
| Heise et al. 2003. Hypoglycemia warning signal and glucose sensors: Requirements and concepts. Diabetes Technology & Therapeutics 5:563-571. |
| Heller 1990. Electrical wiring of redox enzymes. Acc. Chem. Res. 23:128-134. |
| Heller, A. 1992. Electrical Connection of Enzyme Redox Centers to Electrodes. J. Phys. Chem. 96:3579-3587. |
| Heller, A. 1999. Implanted electrochemical glucose sensors for the management of diabetes. Annu Rev Biomed Eng 1:153-175. |
| Heller A. 2003. Plugging metal connectors into enzymes. Nature Biotechnology 21:631-632. |
| Hicks, 1985. In Situ Monitoring. Clinical Chemistry 31(12):1931-1935. |
| Hitchman, M. L. 1978. Measurement of Dissolved Oxygen. In Elving et al. (Eds.). . New York: John Wiley & Sons, Chemical Analysis, vol. 49, Chap. 3, pp. 34-49, 59-123. |
| Hoel, Paul G. 1976. Elementary Statisics, Fourth Edition. John Wiley & Sons, Inc.. pp. 113-114. |
| Hrapovic et al. 2003. Picoamperometric detection of glucose at ultrasmall platinum-based biosensors: preparation and characterization. Analytical Chemistry 75:3308-3315. |
| http://www.merriam-webster.com/dictionary, definition for “aberrant,” Aug. 19, 2008, p. 1. |
| Huang et al. Aug. 1975. Electrochemical Generation of Oxygen. 1. The Effects of Anions and Cations on Hydrogen Chemisorption and Anodic Oxide Film Formation on Platinum Electrode. 2: The Effects of Anions and Cations on Oxygen Generation on Platinum Electrode. U.S. Department of Commerce/NTIS, pp. 1-116. |
| Huang et al., Sep. 1997. A 0.5mW Passive Telemetry IC for Biomedical Applications. Proceedings of the 23rd European Solid-State Circuits Conference (ESSCIRC '97), pp. 172-175, Southampton, UK. |
| Huet al. 1993. A needle-type enzyme-based lactate sensor for in vivo monitoring. Analytica Chimica Acta, 281:503-511. |
| Hunter et al. Mar. 31, 2000. Minimally Invasive Glucose Sensor and Insulin Delivery System. MIT Home Automation and Healthcare Consortium. Progress Report No. 2-5. 17 pages. |
| Ishikawa et al. 1998. Initial evaluation of a 290-mm diameter subcutaneous glucose sensor: Glucose monitoring with a biocompatible, flexible-wire, enzyme-based amperometric microsensor in diabetic and nondiabetic humans. J of Diabetes and Its Complications 12:295-301. |
| Jablecki et al. 2000. Simulations of the frequency response of implantable glucose sensors. Analytical Chemistry 72:1853-1859. |
| Jaffari et al. 1995. Recent advances in amperometric glucose biosensors for in vivo monitoring. Physiol. Meas. 16: 1-15. |
| Jaremko et al. 1998. Advances toward the implantable artificial pancreas for treatment of diabetes. Diabetes Care 21(3):444-450. |
| Jensen et al. 1997. Fast wave forms for pulsed electrochemical detection of glucose by incorporation of reductive desorption of oxidation products. Analytical Chemistry 69(9):1776-1781. |
| Jeong et al. 2003. In vivo calibration of the subcutaneous amperometric glucose sensors using a nonenzyme electrode. Biosensors and Bioelectronics 19:313-319. |
| Jeutter et al. 1993. Design of a radio-linked implantable cochlear prosthesis using surface acoustic wave devices. IEEE Transactions on Ultrasonics, Ferroelectrics and Frequency Control 40(5):469-477. |
| Jeutter, D. C. 1982. A transcutaneous implanted battery recharging and biotelemeter power switching system. IEEE Trans Biomed Eng (BME) 29:314-321. |
| Jobst et al. 1996. Thin-Film Microbiosensors for Glucose-Lactate Monitoring. Analytical Chemistry 8(18): 3173-3179. |
| Johnson 1991. Reproducible electrodeposition of biomolecules for the fabrication of miniature electroenzymatic biosensors. Sensors and Actuators B 5:85-89. |
| Johnson et al. 1992. In vivo evaluation of an electroenzymatic glucose sensor implanted in subcutaneous tissue. Biosensors & Bioelectronics 7:709-714. |
| Joung et al. 1998. An energy transmission system for an artificial heart using leakage inductance compensation of transcutaneous transformer. IEEE Transactions on Power Electronics 13(6):1013-1022. |
| Jovanovic, L. 2000. The role of continuous glucose monitoring in gestational diabetes meliitus. Diabetes Technology & Therapeutics (Suppl 1):S67-S71. |
| Kacaniklic et al. May-Jun. 1994. Amperometric Biosensors for Detection of L- and D-Amino Acids Based on Coimmoblized Peroxidase and L- and D-Amino Acid Oxidases in Carbon Paste Electrodes. Electroanalysis, 6(5-6): 381-390. |
| Kamath et al. Nov. 13-15, 2008. (Abstract) Calibration of a continuous glucose monitor: effect of glucose rate of change. Eighth Annual Diabetes Technology Meeting, p. A88. |
| Kang et al. 2003. In vitro and short-term in vivo characteristics of a Kel-F thin film modified glucose sensor. Anal Sci 19:1481-1486. |
| Kaufman et al. 2001. A pilot study of the continuous glucose monitoring system. D iabetes Care 24(12):2030-2034. |
| Kaufman. 2000. Role of the continuous glucose monitoring system in pediatric patients. Diabetes Technology & Therapeutics 2(1):S-49-S-52. |
| Kawagoe et al. 1991. Enzyme-modified organic conducting salt microelectrode. Analytical Chemistry 63:2961-2965. |
| Keedy et al. 1991. Determination of urate in undiluted whole blood by enzyme electrode. Biosensors & Bioelectronics 6:491-499. |
| Kerner et al. 1988. A potentially implantable enzyme electrode for amperometric measurement of glucose. Horm Metab Res Suppl. 20:8-13. |
| Kerner et al. 1993. The function of a hydrogen peroxide-detecting electroenzymatic glucose electrode is markedly impaired in human sub-cutaneous tissue and plasma. Biosensors & Bioelectronics 8:473-482. |
| Kerner, W. 2001. Implantable glucose sensors: Present status and future developments. Exp. Clin. Endocrinol. Diabetes 109(Suppl 2):S341-S346. |
| Klueh et al. 2003. Use of Vascular Endothelial Cell Growth Factor Gene Transfer to Enhance Implantable Sensor Function in Vivo, Biosensor Function and Vegf Gene Transfer. J Biomed Matls Res 67A:1072-1086. |
| Kondo et al. 1982. A miniature glucose sensor, implantable in the blood stream. Diabetes Care. 5(3):218-221. |
| Koschinsky et al. 1988. New approach to technical and clinical evaluaton of devices for self-monitoring of blood glucose. Diabetes Care 11(8): 619-619. |
| Koschinsky et al. 2001. Sensors for glucose monitoring: Technical and clinical aspects. Diabetes Metab Res Rev 17:113-123. |
| Kost et al. 1985. Glucose-sensitive membranes containing glucose oxidase: activity, swelling, and permeability studies. J Biomed Matls Res 19:1117-1133. |
| Koudelka et al. 1989. In vivo response of microfabricated glucose sensors to glycemia changes in normal rats. Biomed Biochim Acta 48(11-12):953-956. |
| Koudelka et al. 1991. In-vivo behaviour of hypodermically implanted microfabricated glucose sensors. Biosensors & Bioelectronics 6:31-36. |
| Kovatchev et al. Aug. 2004. Evaluating the accuracy of continuous glucose-monitoring sensors: continuous glucose-error grid analysis illustrated by TheraSense Freestyle Navigator data. Diabetes Care 27(8): 1922-1928. |
| Kraver et al. 2001. A mixed-signal sensor interface microinstrument. Sensors and Actuators A 91:266-277. |
| Krouwer, J. S. 2002. Setting performance goals and evaluating total analytical error for diagnostic assays. Clinical Chemistry 48(6):919-927. |
| Kruger et al. 2000. Psychological motivation and patient education: A role for continuous glucose monitoring. Diabetes Technology & Therapeutics 2(Suppl 1):S93-S97. |
| Kulys et al., 1994. Carbon-paste biosensors array for long-term glucose measurement. Biosensors & Bioelectronics 9:491-500. |
| Kunjan et al. Mar. 2008. Automated blood sampling and glucose sensing in critical care settings. J Diabetes Science and Technology 2(3):194-200. |
| Kurnik et al. 1999. Application of the mixtures of experts algorithm for signal processing in a noninvasive glucose monitoring system. Sensors and Actuators B 60:19-26. |
| Kurtz et al. 2005. Recommendations for blood pressure measurement in humans and experimental animals, Part 2: Blood pressure measurement in experimental animals, a statement for professionals from the subcommittee of professional and public education of the American Heart Association Council on High Blood Pressure Research. Hypertension 45:299-310. |
| LaCourse et al. 1993. Optimization of waveforms for pulsed amperometric detection of carbohydrates based on pulsed voltammetry. Analytical Chemistry 65:50-52. |
| Ladd et al. 1996. Structure Determination by X-ray Crystallography, 3rd ed. Plenum, 1996, Ch. 1, pp. xxi-xxiv and 1-58. |
| Lehmann et al. May 1994. Retrospective validation of a physiological model of glucose-insulin interaction in type 1 diabetes mellitus. Med Eng Phys 16:193-202. |
| Lerner et al. 1984. An implantable electrochemical glucose sensor. Ann. N. Y. Acad. Sci. 428:263-278. |
| Lewandowski et al. 1988. Evaluation of a miniature blood glucose sensor. Trans Am Soc Artif Intern Organs 34:255-258. |
| Leypoldt et al. 1984. Model of a two-substrate enzyme electrode for glucose. Analytical Chemistry 56:2896-2904. |
| Linke et al. 1994. Amperometric biosensor for in vivo glucose sensing based on glucose oxidase immobilized in a redox hydrogel. Biosensors & Bioelectronics 9:151-158. |
| Lohn et al. 1999. A knowledge-based system for real-time validation of calibrations and measurements. Chemometrics and Intelligent Laboratory Systems 46:57-66. |
| Lowe, 1984. Biosensors. Trends in Biotechnology 2(3):59-65. |
| Luong et al. 2004. Solubilization of Multiwall Carbon Nanotubes by 3-Aminopropyltriethoxysilane Towards the Fabrication of Electrochemical Biosensors with Promoted Electron Transfer. Electronanalysis 16(1-2):132-139. |
| Lyandres et al. 2008. Progress toward an in vivo surface-enhanced raman spectroscopy glucose sensor. Diabetes Technology & Therapeutics 10(4):257-265. |
| Lynch et al. 2001. Estimation-based model predictive control of blood glucose in type I diabetics; A simulation study. Proceedings of the IEEE 27th Annual Northeast Bioengineering Conference, pp. 79-80. |
| Lynn, P. A. 1971. Recursive digital filters for biological signals. Med & Biol Eng 9:37-43. |
| Maidan et al. 1992. Elimination of Electrooxidizable Interferent-Produced Currents in Amperometric Biosensors. Analytical Chemistry 64:2889-2896. |
| Makale et al. 2003. Tissue window chamber system for validation of implanted oxygen sensors. Am. J. Physiol. Heart Circ. Physiol. 284:H2288-2294. |
| Malin et al. 1999. Noninvasive Prediction of Glucose by Near-Infrared Diffuse Reflectance Spectroscopy. Clinical Chemistry 45(9):1651-1658. |
| Mancy et al. 1962. A galvanic cell oxygen analyzer. J Electroanalytical Chemistry 4:65-92. |
| Maran et al. 2002. Continuous subcutaneous glucose monitoring in diabetic patients: A multicenter analysis. Diabetes Care 25(2):347-352. |
| March, W. F. 2002. D ealing with the delay. Diabetes Technology & Therapeutics 4(1):49-50. |
| Marena et al. 1993. The artificial endocrine pancreas in clinical practice and research. Panminerva Medica 35(2): 67-74. |
| Markwell Medical 1990. Direct 30/30® Blood Glucose Sensor, ELCO Diagnostics Company (1 page). |
| Martin, R. F. 2000. General Deming regression for estimating systematic bias and its confidence interval in method-comparison studies. Clinical Chemistry 46(1):100-104. |
| Mascini et al. 1989. Glucose electrochemical probe with extended linearity for whole blood. J Pharm Biomed Anal 7(12):1507-1512. |
| Mastrototaro et al. 1991. An electroenzymatic glucose sensor fabricated on a flexible substrate. Sensors and Actuators B 5:139-144. |
| Mastrototaro et al. 2003. Reproducibility of the continuous glucose monitoring system matches previous reports and the intended use of the product. Diabetes Care 26:256: author reply p. 257. |
| Mastrototaro, J. J. 2000. The MiniMed continuous glucose monitoring system. Diabetes Technology & Therapeutics 2(Suppl 1):S13-S18. |
| Matsuki. 1994. Energy transfer system utilizing amorphous wires for implantable medical devices. IEEE Trans on Magnetics 31 (2):1276-1282. |
| Matsumoto et al. 1998. A micro-planar amperometric glucose sensor unsusceptible to interference species. Sensors and Actuators B 49:68-72. |
| Matthews et al. 1988. An amperometric needle-type glucose sensor testing in rats and man. Diabetic Medicine 5:248-252. |
| Mazze et al. 2008. Characterizing glucose exposure for individuals with normal glucose tolerance using continuous glucose monitoring and ambulatory glucose profile analysis. Diabetes Technology & Therapeutics 10:149-159. |
| Mazzola et al., Oct. 1983. Video Diabetes: A Teaching Tool for Children with Insulin-Dependent Diabetes, Proceedings—7th Annual Symposium on Computer Applications in Medical Care; Washington, D.C.; Dialog:, File 8, Acc# 01624462, 1 page Abstract. |
| McCartney et al. 2001. Near-infrared fluorescence lifetime assay for serum glucose based on allophycocyanin-labeled concanavalin A. Anal Biochem 292:216-221. |
| McGrath et al. 1995. The use of differential measurements with a glucose biosensor for interference compensation during glucose determinations by flow injection analysis. Biosensors & Bioelectronics 10:937-943. |
| McKean et al. Jul. 7, 1988. A Telemetry Instrumentation System for Chronically Implanted Glucose and Oxygen Sensors. Trans Biomed Eng (BME) 35:526-532. |
| Memoli et al. 2002. A comparison between different immobilised glucoseoxidase-based electrodes. J Pharm Biomed Anal 29:1045-1052. |
| Merriam-Webster Online Dictionary. Jan. 11, 2010. Definition of “acceleration”. http://www.merriam-webster.com/dictionary/Acceleration. |
| Merriam-Webster Online Dictionary. Jan. 11, 2010. Definition of “system”. http://www.merriam-webster.com/dictionary/System. |
| Merriam-Webster Online Dictionary. Apr. 23, 2007. Definition of “nominal”. http://www.merriam-webster.com/dictionary/nominal. |
| Metzger et al. Jul. 2002. Reproducibility of glucose measurements using the glucose sensor. Diabetes Care 25(6):1185-1191. |
| Meyerhoff et al. 1992. On line continuous monitoring of subcutaneous tissue glucose in men by combining portable glucosensor with microdialysis. Diabetologia 35:1087-1092. |
| Miller et al. 1993. Development of an autotuned transcutaneous energy transfer system. Asaio J 39:M706-M710. |
| Moatti-Sirat et al. 1992. Evaluating in vitro and in vivo the interference of ascorbate and acetaminophen on glucose detection by a needle-type glucose sensor. Biosensors & Bioelectronics 7:345-352. |
| Moatti-Sirat et al. 1992. Towards continuous glucose monitoring: in vivo evaluation of a miniaturized glucose sensor implanted for several days in rat subcutaneous tissue. Diabetologia 35:224-230. |
| Moatti-Sirat et al. Jun. 1994. Reduction of acetaminophen interference in glucose sensors by a composite Nation membrane: demonstration in rats and man. Diabetologia 37(6):610-616. |
| Monsod et al. 2002. Do sensor glucose levels accurately predict plasma glucose concentrations during hypoglycemia and hyperinsulinemia? Diabetes Care 25(5):889-893. |
| Morff et al. 1990. Microfabrication of reproducible, economical, electroenzymatic glucose sensors. Annual International Conference of the IEEE Engineering in Medicine and Biology Society 12(2):0483-0484. |
| Mosbach et al. 1975. Determination of heat changes in the proximity of immobilized enzymes with an enzyme thermistor and its use for the assay of metabolites. Biochim Biophys Acta 403:256-265. |
| Motonaka et al. 1993. Determination of cholesterol and cholesterol ester with novel enzyme microsensors. Analytical Chemistry 65:3258-3261. |
| Moussy et al. 1993. Performance of subcutaneously implanted needle-type glucose sensors employing a novel trilayer coating. Analytical Chemistry 85: 2072-2077. |
| Moussy et al. 1994. A miniaturized Nafion-based glucose sensor: In vitro and in vivo evaluation in dogs. Int J Artif Organs 17(2):88-94. |
| Moussy, Francis, Nov. 2002. Implantable Glucose Sensor: Progress and Problems. Sensors 1:270-273. |
| Muslu. 1991. Trickling filter performance. Applied Biochem Biotech 37:211-224. |
| Neuburger et al. 1987. Pulsed amperometric detection of carbohydrates at gold electrodes with a two-step potential waveform. Analytical Chemistry 59:150-154. |
| Nintendo Healthcare, Wired, Dec. 1993. |
| Novo Nordisk 1994. Diabetes Educational Video Game Recognized by Software Publishers Association, Press Release, Novo Nordisk, Mar. 14, 1994. |
| Ohara et al. 1994. “Wired” enzyme electrodes for amperometric determination of glucose or lactate in the presence of interfering substances. Analytical Chemistry 66:2451-2457. |
| Oharaet al. Dec. 1993. Glucose electrodes based on cross-linked bis(2,2′-bipyridine)chloroosmium(+/2+) complexed poly(l-vinylimidazole) films. Analytical Chemistry 65:3512-3517. |
| Okuda et al. 1971. Mutarotase effect on micro deteminations of D-glucose and its anomers with (3-D-glucose oxidase. Anal Biochem 43:312-315. |
| Oxford English Dictionary Online. Jan. 11, 2010. Definition of “impending”. http://www.askoxford.com/results/?view=dev dict&field-12668446 lmpending&branch=. |
| Palmisano et al. 2000. Simultaneous monitoring of glucose and lactate by an interference and cross-talk free dual electrode amperometric biosensor based on electropolymerized thin films. Biosensors & Bioelectronics 15:531-539. |
| Panteleon et al. 2003. The role of the independent variable to glucose sensor calibration. Diabetes Technology & Therapeutics 5(3):401-410. |
| Parker et al. 1999. A model-based algorithm for blood glucose control in type I diabetic patients. IEEE Trans Biomed Eng (BME) 46(2):148-157. |
| Patel et al. 2003. Amperometric glucose sensors based on ferrocene containing polymeric electron transfer systems—a preliminary report. Biosensors & Bioelectronics 18:1073-1076. |
| Peacock et al. 2008. Cardiac troponin and outcome in acute heart failure. NEJM 358:2117-2126. |
| Pfeiffer et al. 1992. On line continuous monitoring of subcutaneous tissue glucose is feasible by combining portable glucosensor with microdialysis. Horm Metab Res 25:121-124. |
| Pfeiffer, E.F. 1990. The glucose sensor: the missing link in diabetes therapy. Horm Metab Res Suppl. 24:154-164. |
| Phillips. 1995. A high capacity transcutaneous energy transmission system. Asaio Journal 41:M259-M262. |
| Pichert et al. 2000. Issues for the coming age of continuous glucose monitoring. Diabetes Educ 26(6):969-980. |
| Pickup et al. 1987/88. Implantable glucose sensors: choosing the appropriate sensing strategy. Biosensors 3:335-346. |
| Pickup et al. 1989. In vivo molecular sensing in diabetes meliitus: an implantable glucose sensor with direct electron transfer. Diabetologia 32:213-217. |
| Pickup et al. 1989. Potentially-implantable, amperometric glucose sensors with mediated electron transfer: improving the operating stability. Biosensors 4:109-119. |
| Pickup et al. 1993. Responses and Calibration of Amperometric Glucose Sensors Implanted in the Subcutaneous Tissue of Man. ACTA Diabetol 30:143-148. |
| Pinner et al. Oct. 1959. Cross-linking of cellulose acetate by ionizing radiation. Nature 184:1303-1304. |
| Pishko et al. 1991. “Amperometric glucose microelectrodes prepared through immobilization of glucose oxidase in redox hydrogels,” Analytical Chemistry, 63:2268-72. |
| Pitzer et al. 2001. Detection of hypoglycemia with the GlucoWatch biographer. Diabetes Care 24(5):881-885. |
| Poirier et al. 1998. Clinical and statistical evaluation of self-monitoring blood glucose meters. Diabetes Care 21(11):1919-1924. |
| Poitout et al. 1991. In Vitro and In Vivo Evaluation in Dogs of a Miniaturized Glucose Sensor. Asaio Transactions 37:M298-M300. |
| Poitout et al. 1993. A glucose monitoring system for on line estimation in man of blood glucose concentration using a miniaturized glucose sensor implanted in the subcutaneous tissue and a wearable control unit. Diabetologia 36:658-663. |
| Poitout et al. 1994. Development of a glucose sensor for glucose monitoring in man: the disposable implant concept. Clinical Materials 15:241-246. |
| Postlethwaite et al. 1996. Interdigitated array electrode as an alternative to the rotated ring-disk electrode for determination of the reaction products of dioxygen reduction. Analytical Chemistry 68:2951-2958. |
| Prabhu et al. 1981. Electrochemical studies of hydrogen peroxide at a platinum disc electrode. Electrochimica Acta 26(6):725-729. |
| Quinn et al. 1995. Kinetics of glucose delivery to subcutaneous tissue in rats measured with 0.3-mm amperometric microsensors. The American Physiological Society E155-E161. |
| Quinn et al. 1997. Biocompatible, glucose-permeable hydrogel for in situ coating of implantable biosensors. Biomaterials 18:1665-1670. |
| Rabah et al. 1991. Electrochemical wear of graphite anodes during electrolysis of brine. Carbon 29(2):165-171. |
| Raya Systems Pioneers Healihy Video Games, PlayRight, Nov. 1993 (pp. 14-15). |
| Reach et al. 1986. A Method for Evaluating in vivo the Functional Characteristics of Glucose Sensors. Biosensors 2:211-220. |
| Reach et al. 1992. Can continuous glucose monitoring be used for the treatment of diabetes? Analytical Chemistry 64(5):381-386. |
| Reach, G. 2001. Which threshold to detect hypoglycemia? Value of receiver-operator curve analysis to find a compromise between sensitivity and specificity. Diabetes Care 24(5):803-804. |
| Reach, Gerard. 2001. Letters to the Editor Re: Diabetes Technology & Therapeutics (2000) 2:49-56. Diabetes Technology & Therapeutics 3(1): 129-130. |
| Rebrin et al. 1989. Automated feedback control of subcutaneous glucose concentration in diabetic dogs. Diabetologia 32:573-576. |
| Rebrin et al. 1992. Subcutaneous glucose monitoring by means of electrochemical sensors: fiction or reality? J Biomed Eng 14:33-40. |
| Rebrin et al. 1999. Subcutaneous glucose predicts plasma glucose independent of insulin: Implications for continuous monitoring. Am J Physiol 277:E561-E571. |
| Reusch 2004. Chemical Reactivity. Organometallic Compounds. Virtual Textbook of Organic Chem. pp. 1-16, http://www.cem.msu.edu/˜reusch/VirtualText/orgmetal.htm. |
| Rhodes et al. 1994. Prediction of pocket-portable and implantable glucose enzyme electrode performance from combined species permeability and digital simulation analysis. Analytical Chemistry. 66(9):1520-1529. |
| Rigla et al. 2008. Real-time continuous glucose monitoring together with telemedical assistance improves glycemic control and glucose stability in pump-treated patients. Diabetes Technology & Therapeutics 10(3):194-199. |
| Rinken et al. 1998. Calibration of glucose biosensors by using pre-steady state kinetic data. Biosensors & Bioelectronics 13:801-807. |
| Rivers et al. 2001. Central venous oxygen saturation monitoring in the critically ill patient. Current Opinion in Critical Care 7:204-211. |
| Sakakida et al. 1992. Development of Ferrocene-Mediated Needle-Type Glucose Sensor as a Measure of True Subcutaneous Tissue Glucose Concentrations. Artif Organs Today 2(2):145-158. |
| Sakakida et al. 1993. Ferrocene-Mediated Needle Type Glucose Sensor Covered with Newly Designed Biocompatible Membran. Sensors and Actuators B 13-14:319-322. |
| Salardi et al. 2002. The glucose area under the profiles obtained with continuous glucose monitoring system relationships with HbA1c in pediatric type 1 diabetic patients. Diabetes Care 25(10): 1840-1844. |
| Samuels, M.P. 2004. The effects of flight and altitude. Arch Dis Chil. 89 448-455. |
| San Diego Plastics, Inc. 2009. Polyethylene Data Sheet, http://www.sdplastics.com/polyeth.html. |
| Sansen et al., 1985. Glucose sensor with telemetry system. Chapter 12, pp. 167-175 in Ko, W. H. (Ed.). Implantable Sensors for Closed Loop Prosthetic Systems, Mount Kisco, NY: Futura Publishing Co. |
| Sansen et al. 1990. A smart sensor for the voltammetric measurement of oxygen or glucose concentrations. Sensors and Actuators B 1:298-302. |
| Schmidt et al. 1992. Calibration of a wearable glucose sensor. The International Journal of Artificial Organs 15(1 ):55-61. |
| Schmidt et al. 1993. Glucose concentration in subcutaneous extracellular space. Diabetes Care 16(5):695-700. |
| Schmidtke et al. Jan. 1998. Measurement and modeling of the transient difference between blood and subcutaneous glucose concentrations in the rat after injection of insulin. PNAS USA 95:294-299. |
| Schmidtke et al. May 1998. Accuracy of the one-point in vivo calibration of “wired” glucose oxidase electrodes implanted in jugular veins of rats in periods of rapid rise and decline of the glucose concentration. Analytical Chemistry 70(10):2149-2155. |
| Schoemaker et al. 2003. The SCGM1 system: Subcutaneous continuous glucose monitoring based on microdialysis technique. Diabetes Technology & Therapeutics 5(4):599-608. |
| Schoonen et al. 1990 Development of a potentially wearable glucose sensor for patients with diabetes meliitus: design and in-vitro evaluation. Biosensors & Bioelectronics 5:37-46. |
| Service et al. 1970. Mean amplitude of glycemic excursions, a measure of diabetic instability. Diabetes 19: 644-655. |
| Service et al. 1987. Measurements or glucose control. Diabetes Care 10:225-237. |
| Service, R. F. 2002. Can sensors make a home in the body? 29:962-963. |
| Sharkawy et al. 1997. Engineering the tissue which encapsulates subcutaneous implants. 1. Diffusion properties. J Biomed Mater Res 37:401-412. |
| Shaw et al. 1991. In vitro testing of a simply constructed, highly stable glucose sensor suitable for implantation in diabetic patients. Biosensors & Bioelectronics 6:401-406. |
| Shichiri et al. 1982. Wearable artificial endocrine pancreas with needle-type glucose sensor. Lancet 2:1129-1131. |
| Shichiri et al. 1985. Needle Type Glucose Sensor for Wearable Artificial Endocrine Pancreas. Chapter 15, pp. 197-210 in Implantable Sensors for Closed-Loop Prosthetic Systems, Ko (Ed), Futura Publishing Co., Mt. Kisko. NY. |
| Shichiri et al. 1985. Needle-Type Glucose Sensor for Wearable Artificial Endocrine Pancreas. Chapter 15, pp. 197-210 in Ko, Wen H. 1985. Implantable Sensors for Closed-Loop Prosthetic Systems, Futura Pub. Co., Inc., Mt. Kisco, NY. |
| Shichiri et al. 1986. Telemetry Glucose Monitoring Device with Needle-Type Glucose Sensor: A Useful Tool for Blood Glucose Monitoring in Diabetic Individuals. Diabetes Care, Inc. 9(3):298-301. |
| Shults et al. 1994. A telemetry-instrumentation system for monitoring multiple subcutaneously implanted glucose sensors. IEEE Trans Biomed Eng (BME) 41(10):937-942. |
| Sigma-Aldrich Corp., 2005. Nation® 117 Solution Product Description, Product No. 70160, Sigma-Aldrich Corp., St. Louis, MO. Downloaded from https://www.signaaldrich.com/cgi-bin/hsrun/Suite7/Suite/HAHTpage/Suite.HsExternal Prod . . . on Apr. 7, 2005. |
| Skyler, J. S. 2000. The economic burden of diabetes and the benefits of improved glycemic control: The potential role of a continuous glucose monitoring system. Diabetes Technology & Therapeutics 2(Suppl 1):S7-S12. |
| Slater-Maclean et al. 2008. Accuracy of glycemic measurements in the critically ill. Diabetes Technology & Therapeutics 10:169-177. |
| Smith et al. 1998. An externally powered, multichannel, implantable stimulator-telemeter for control of paralyzed muscle. IEEE Trans Biomed Eng (BME) 45(4):463-475. |
| Sokol et al. 1980. Immobilized-enzyme rate-determination method for glucose analysis. Clin Chem 26(1 ):89-92. |
| Sokolov et al. 1995. Metrological opportunities of the dynamic mode of operating an enzyme amperometric biosensor. Med Eng Phys 17(6):471-476. |
| Sparacino et al. 2008. Continuous glucose monitoring time series and hypo/hyperglycemia prevention: requirements, methods, open problems. Current Diabetes Review, 4:181-192. |
| Sproule et al. 2002. Fuzzy pharmacology: Theory and applications. Trends in Pharmacological Sciences 23(9):412-417. |
| Sriyudthsak et al. 1996. Enzyme-epoxy membrane based glucose analyzing system and medical applications. Biosensors & Bioelectronics 11:735-742. |
| Steil et al. 2003. Determination of plasma glucose during rapid glucose excursions with a subcutaneous glucose sensor. Diabetes Technology & Therapeutics 5(1 ):27-31. |
| Stern et al., 1957. Electrochemical polarization: 1. A theoretical analysis of the shape of polarization curves. J Electrochemical Soc.104(1):56-63. |
| Sternberg et al. 1996. Does fall in tissue glucose precede fall in blood glucose? Diabetologia 39:609-612. |
| Street et al. 1988. A note on computing robust regression extimates via iteratively reweighted least squares. The American Statistician 42(2):152-154. |
| Sumino, T. et al. 1998. Preliminary study of continuous glucose monitoring with a microdialysis technique. Proceedings of the IEEE, 20(4):1775-1778. |
| Takegami et al. 1992. Pervaporation of ethanol water mixtures using novel hydrophobic membranes containing polydimethylsiloxane. J Membrane Sci 75:93-105. |
| Tamura, T. et al. 2000. Preliminary study of continuous glucose monitoring with a microdialysis technique and a null method—a numerical analysis. Frontiers Med Biol Eng 10(2):147-156. |
| Tanenberg et al. 2000. Continuous glucose monitoring system: A new approach to the diagnosis of diabetic gastroparesis. Diabetes Technology & Therapeutics 2(Suppl 1):S73-S80. |
| Tatsuma et al. 1991. Oxidase/peroxidase bilayer-modified electrodes as sensors for lactate, pyruvate, cholesterol and uric acid. Analytica Chimica Acta 242:85-89. |
| TheraSense, Inc. 2002. Freestyle—Blood Glucose Monitoring System, Owner's Booklet, p. 68. |
| Thijssen et al. 1984. A Kalman Filter for Calibration, Evaluation of Unknown Samples and Quality Control in Drifting Systems, Part 1. Theory and Simulations. Anal Chim Acta 156:87-101. |
| Thijssen et al. 1985. A Kalman Filter for Calibration, Evaluation of Unknown Samples and Quality Control in Drifting Systems, Part 3. Variance Reduction. Anal Chim Acta 173:265-272. |
| Thijssen et al. 1985. A Kalman Filter for Calibration, Evaluation of Unknown Samples and Quality Control in Drifting Systems, Part 4. Flow Injection Analysis. Anal Chim Acta 174:27-40. |
| Thijssen, P.C. 1984. A Kalman Filder for Calibration, Evaluation of Unknown Samples and Quality Control in Drifting Systems, Part 2. Optimal Designs. Anal Chim Acta 162:253-262. |
| Thome et al. 1995. (Abstract) Can the decrease in subcutaneous glucose concentration precede the decrease in blood glucose level? Proposition for a push-pull kinetics hypothesis. Horm Metab Res 27:53. |
| Thome-Duret et al. 1996. Modification of the sensitivity of glucose sensor implanted into subcutaneous tissue. D iabetes Metabolism 22:174-178. |
| Thome-Duret et al. 1996. Use of a subcutaneous glucose sensor to detect decreases in glucose concentration prior to observation in blood. Analytical Chemistry 68:3822-3826. |
| Thome-Duret et al. 1998. Continuous glucose monitoring in the free-moving rat. Metabolism 47:799-803. |
| Thompson et al. 1986. In Vivo Probes: Problems and Perspectives, Department of Chemistry, University of Toronoto, Canada, pp. 255-261. |
| Tierney et al. 2000. Effect of acetaminophen on the accuracy of glucose measurements obtained with the GlucoWatch biographer. Diabetes Technology & Therapeutics 2(2):199-207. |
| Tierney et al. 2000. The GlucoWatch® biographer: A frequent, automatic and noninvasive glucose monitor. Ann Med 32:632-641. |
| Tilbury et al. 2000. Receiver operating characteristic analysis for intelligent medical systems—A new approach for finding confidence intervals. IEEE Trans Biomed Eng (BME) 47(7):952-963. |
| Torjman et al. Mar. 2008. Glucose monitoring in acute care: technologies on the horizon. J Diabetes Science and Technology 2(2):178-181. |
| Trajanoski et al. 1998. Neural predictive controller for insulin delivery using the subcutaneous route. IEEE Trans Biomed Eng (BME) 45(9):1122-1134. |
| Trecroci, D. 2002. A Glimpse into the Future-Continuous Monitoring of Glucose with a Microfiber. Diabetes Interview 42-43. |
| Tse and Gough. 1987. Time-Dependent Inactivation of Immobilized Glucose Oxidase and Catalase. Biotechnol Bioeng 29:705-713. |
| Turner and Pickup 1985. Diabetes mellitus: biosensors for research and management. Biosensors 1:85-115. |
| Turner et al. 1984. Carbon Monoxide: Acceptor Oxidoreductase from Pseudomonas Thermocarboxydovorans Strain C2 and its use in a Carbon Monoxide Sensor. Analytica Chimica Acta 163:161-174. |
| Unger et al. 2004. Glucose control in the hospitalized patient. Emerg Med 36(9):12-18. |
| Updike et al. 1967. The enzyme electrode. Nature 214:986-988. |
| Updike et al. 1979. Continuous glucose monitor based on an immobilized enzyme electrode detector. J Lab Clin Med 93(4):518-527. |
| Updike et al. 1982. Implanting the glucose enzyme electrode: Problems, progress, and alternative solutions. Diabetes Care 5(3):207-212. |
| Updike et al. 1988. Laboratory Evaluation of New Reusable Blood Glucose Sensor. Diabetes Care 11:801-807. |
| Updike et al. 1994. Enzymatic glucose sensor: Improved long-term performance in vitro and in vivo. Asaio Journal 40(2):157-163. |
| Updike et al. 1997. Principles of long-term fully implanted sensors with emphasis on radiotelemetric monitoring of blood glucose form inside a subcutaneous foreign body capsule (FBC). Fraser, D.M. (Ed.), Biosensors in the Body. New York. John Wiley & Sons Ltd., pp. 117-137. |
| Updike et al. 2000. A subcutaneous glucose sensor with improved longevity, dynamic range, and stability of calibration. Diabetes Care 23(2):208-214. |
| Utah Medical Products Inc., 2003. Blood Pressure Transducers product specifications 2003-2006 (6 pages). |
| Vadgama, P. Nov. 1981. Enzyme electrodes as practical biosensors. J Med Eng Tech 5(6):293-298. |
| Vadgama. 1988. Diffusion limited enzyme electrodes. NATO ASI Series: Series C, Math and Phys. Sci. 226:359-377. |
| Valdes et al. 2000. In vitro and in vivo degradation of glucose oxidase enzyme used for an implantable glucose biosensor. Diabetes Technology & Therapeutics 2:367-376. |
| Van den Berghe 2004. Tight blood glucose control with insulin in “real-life” intensive care. Mayo Clin Proc 79(8):977-978. |
| Velho et al. 1989. In vitro and in vivo stability of electrode potentials in needle-type glucose sensors. Influence of needle material. Diabetes 38:164-171. |
| Velho et al. 1989. Strategies for calibrating a subcutaneous glucose sensor. Biomed Biochim Acta 48(11/12):957-964. |
| Von Woedtke et al. 1989. In situ calibration of implanted electrochemical glucose sensors. Biomed Biochim. Acta 48(11/12):943-952. |
| Wagner et al. 1998. Continuous amperometric monitoring of glucose in a brittle diabetic chimpanzee with a miniature subcutaneous electrode. PNAS USA 95:6379-6382. |
| Wang et al. 1994. Highly Selective Membrane-Free, Mediator-Free Glucose Biosensor, Analytical Chemistry 66:3600-3603. |
| Wang et al. 1997. Improved ruggedness for membrane-based amperometric sensors using a pulsed amperometric method. Analytical Chemistry 69:4482-4489. |
| Ward et al. 1999. Assessment of chronically implanted subcutaneous glucose sensors in dogs: The effect of surrounding fluid masses. ASAIO Journal 45:555-561. |
| Ward et al. 2000. Rise in background current overtime in a subcutaneous glucose sensor in the rabbit: Relevance to calibration and accuracy. Biosensors & Bioelectronics 15:53-61. |
| Ward et al. 2000. Understanding Spontaneous Output Fluctuations of an Amperometric Glucose Sensor: Effect of Inhalation Anesthesia and use of a Nonenzyme Containing Electrode. Asaio Journal 46:540-546. |
| Ward et al. 2002. A new amperometric glucose microsensor: In vitro and short-term in vivo evaluation. Biosensors & Bioelectronics 17:181-189. |
| Ward et al. 2004. A wire-based dual-analyte sensor for Glucose and Lactate: In Vitro and In Vivo Evaluation. Diabetes Technology & Therapeutics 6(3):389-401. |
| Wientjes, K. J. C. 2000. Development of a glucose sensor for diabetic patients (Ph.D. Thesis). |
| Wikinedia 2006. “Intravenous therapy,” http://en.wikipedia.org/wiki/Intravenous_therapy, Aug. 15, 2006 (6 pages). |
| Wiley Electrical and Electronics Engineering Dictionary. 2004. John Wiley & Sons, Inc. pp. 141, 142, 548, 549. |
| Wilkins et al. 1988. The coated wire electrode glucose sensor. Horm Metab Res Suppl 20:50-55. |
| Wilkins et al. 1995. Integrated implantable device for long-term glucose monitoring. Biosensors & Bioelectronics 10:485-494. |
| Wilkins et al. 1996. Glucose monitoring: state of the art and future possibilities. Med Eng Phys 18:273-288. |
| Wilson et al. 1992. Progress toward the development of an implantable sensor for glucose. Ciin Chem 38(9):1613-1617. |
| Wilson et al. 2000. Enzyme-based biosensors for in vivo measurements. Chem Rev 100:2693-2704. |
| Wood, W. et al. Mar. 1990. Hermetic Sealing with Epoxy. Mechanical Engineering 1-3. |
| Woodward. 1982. How Fibroblasts and Giant Cells Encapsulate Implants: Considerations in Design of Glucose Sensor. Diabetes Care 5:278-281. |
| Worsley et al. Mar. 2008. Measurement of glucose in blood with a phenylboronic acid optical sensor. J Diabetes Science and Technology 2(2):213-220. |
| Wright et al. 1999. Bioelectrochemical dehalogenations via direct electrochemistry of poly(ethylene oxide)-modified myoglobin. Electrochemistry Communications 1:603-611. |
| Wu et al. 1999. In situ electrochemical oxygen generation with an immunoisolation device. Annals New York Academy of Sciences, pp. 105-125. |
| Yamasaki et al. 1989. Direct measurement of whole blood glucose by a needle-type sensor. Clinica Chimica Acta 93:93-98. |
| Yamasaki, Yoshimitsu, Sep. 1984. The development of a needle-type glucose sensor for wearable artificial endocrine pancreas. Medical Journal of Osaka University 35(1-2):25-34. |
| Yang et al 1996. A glucose biosensor based on an oxygen electrode: In-vitro performances in a model buffer solution and in blood plasma. Biomedical Instrumentation & Technology 30:55-61. |
| Yang et al. 1998. Development of needle-type glucose sensor with high selectivity. Science and Actuators B 46:249-256. |
| Yanget al. 2004. A Comparison of Physical Properties and Fuel Cell Performance of Nafion® and Zirconium Phosphate/Nafion® Composite Membranes, J Membrane Science 237:145-161. |
| Ye et al. 1993. High Current Density Wired' Quinoprotein Glucose Dehydrogenase Electrode. Analytical Chemistry 65:238-241. |
| Zamzow et al. 1990. Development and evaluation of a wearable blood glucose monitor. Asaio Transactions 36(3):M588-M591. |
| Zavalkoff et al. 2002. Evaluation of conventional blood glucose monitoring as an indicator of integrated glucose values using a continuous subcutaneous sensor. Diabetes Care 25(9):1603-1606. |
| Zethelius et al. 2008. Use of multiple biomarkers to improve the prediction of death from cardiovascular causes. NEJM 358:2107-2116. |
| Zhang et al 1993. Electrochemical oxidation of H202 on Pt and Pt + Ir electrodes in physiological buffer and its applicability to H202-based biosensors. J. ElectroAnalytical Chemistry 345:253-271. |
| Zhang et al. 1993. In vitro and in vivo evaluation or oxygen effects on a glucose oxidase based implantable glucose sensor. Analytica Chimica Acta 281:513-520. |
| Zhang et al. 1994. Elimination of the acetaminophen interference in an implantable glucose sensor. Analytical Chemistry 66(7):1183-1188. |
| Zhu et al. 1994. Fabrication and characterization of glucose sensors based on a microarray H202 electrode. Biosensors & Bioelectronics 9: 295-300. |
| Zhu et al. 2002. Planar amperometric glucose sensor based on glucose oxidase immobilized by chitosan film on prussian blue layer. Sensors 2:127-136. |
| Ziaie et al. 1997. A single-channel implantable microstimulator for functional neuromuscular stimulation. IEEE Trans Biomed Eng (BME) 44(10):909-920. |
| EP 05723951.9 [037VEP]: EPO Communication dated Sep. 7, 2010. |
| EP 05723951.9 [037VEP]: EPO Communication dated Nov. 21, 2007. |
| EP 05771646.6, filed Jul. 13, 2005: EPO Communication dated Jun. 2, 2010. |
| EP 05771646.6, filed Jul. 13, 2005: EPO Communication dated Aug. 17, 2011. |
| EP 05771646.6, filed Jul. 13, 2005: EPO Communication dated Aug. 19, 2009. |
| EP 98908875.2, filed Mar. 3, 1998: European Search Report dated Apr. 29, 2004. |
| JP 2006-522016, filed Jul. 27, 2004: JIPO Office action dated Jun. 28, 2011. |
| JP 2006-522016, filed Jul. 27, 2004: JIPO Office action dated Aug. 31, 2010. |
| PCT/US2001/023850, filed Jul. 30, 2001: Written Opinion. |
| PCT/US2001/023850, filed Jul. 30, 2001: International Search Report dated Jan. 16, 2002. |
| PCT/US2001/023850, filed Jul. 30, 2001: International Preliminary Examination Report dated Jun. 4, 2003. |
| PCT/US2004/024263, filed Jul. 27, 2004: International Preliminary Report on Patentability dated Feb. 6, 2006. |
| PCT/US2004/024263, filed Jul. 27, 2004: International Search Report and Written Opinion dated Nov. 29, 2004. |
| PCT/US2004/038724, filed Nov. 17, 2004: International Preliminary Report on Patentability dated Mar. 5, 2009. |
| PCT/US2004/038724, filed Nov. 17, 2004: International Search Report and Written Opinion dated Jan. 9, 2006. |
| PCT/US2004/041095, filed Dec. 8, 2004: International Preliminary Report on Patentability. |
| PCT/US2005/006301, filed Feb. 24, 2005: International Preliminary Report on Patentability. |
| PCT/US2005/006301, filed Feb. 24, 2005: International Search Report and Written Opinion. |
| PCT/US2005/024993, filed Jul. 13, 2005: International Preliminary Report on Patentability dated Jan. 16, 2007. |
| PCT/US2005/024993, filed Jul. 13, 2005: International Search Report and Written Opinion dated Nov. 4, 2005. |
| PCT/US2006/024132, filed Jun. 20, 2006: International Preliminary Report on Patentability dated Dec. 24, 2007. |
| PCT/US2006/024132, filed Jun. 20, 2006: International Search Report and Written Opinion. |
| PCT/US2006/034284, filed Sep. 1, 2006: International Preliminary Report on Patentability. |
| PCT/US2006/034284, filed Sep. 1, 2006: International Search Report and Written Opinion. |
| PCT/US2008/058158, filed Mar. 25, 2008: International Preliminary Report on Patentability. |
| PCT/US2008/058158, filed Mar. 25, 2008: International Search Report and Written Opinion. |
| PCT/US2008/066600, filed Jun. 11, 2008: International Preliminary Report on Patentability dated Dec. 17, 2009. |
| PCT/US2008/066600, filed Jun. 11, 2008: International Search Report and Written Opinion dated Oct. 7, 2008. |
| PCT/US2004/041095, filed Dec. 8, 2004: International Search Report and Written Opinion dated Jun. 1, 2005. |
| U.S. Reexamination Control No. 95/001038 [025AX]: Office Action dated Jun. 17, 2008. |
| U.S. Reexamination Control No. 95/001038 [025AX]: Office Action dated May 28, 2010. |
| U.S. Reexamination Control No. 95/001038 [024AX]: Office Action dated May 29, 2008. |
| U.S. Appl. No. 11/077,740 [051A11]: Office Action dated Jul. 25, 2008. |
| U.S. Appl. No. 09/636,369 [008DP1]: Office Action dated Sep. 30, 2002. |
| U.S. Appl. No. 10/632,537 [024A]: Office Action dated Oct. 20, 2004. |
| U.S. Appl. No. 10/632,537 [024A]: Office Action dated Dec. 21, 2004. |
| U.S. Appl. No. 10/633,329 [026A]: Office Action dated Feb. 4, 2008. |
| U.S. Appl. No. 10/633,329 [026A]: Office Action dated Oct. 5, 2006. |
| U.S. Appl. No. 10/633,329 [026A]: Office Action dated Jun. 11, 2009. |
| U.S. Appl. No. 10/633,329 [026A]: Office Action dated Jun. 12, 2008. |
| U.S. Appl. No. 10/633,329 [026A]: Office Action dated Dec. 18, 2008. |
| U.S. Appl. No. 10/633,329 [026A]: Office Action dated Mar. 26, 2007. |
| U.S. Appl. No. 10/633,329 [026A]: Office Action dated Apr. 27, 2010. |
| U.S. Appl. No. 10/633,329 [026A]: Office Action dated Jul. 30, 2007. |
| U.S. Appl. No. 10/633,367 [016A]: Office Action dated Jun. 11, 2009. |
| U.S. Appl. No. 10/633,404 [025A]: Office Action dated Feb. 12, 2007. |
| U.S. Appl. No. 10/633,67 [016A]: Office Action dated Jul. 15, 2008. |
| U.S. Appl. No. 10/648,849 [027A]: Office Action dated Jun. 23, 2009. |
| U.S. Appl. No. 10/789,359 [037A]: Office Action dated Oct. 3, 2008. |
| U.S. Appl. No. 10/789,359 [037A]: Office Action dated Mar. 20, 2008. |
| U.S. Appl. No. 10/789,359 [037A]: Office Action dated Nov. 27, 2006. |
| U.S. Appl. No. 10/838,909 [044A]: Office Action dated Jun. 5, 2008. |
| U.S. Appl. No. 10/838,909 [044A]: Office Action dated Mar. 16, 2009. |
| U.S. Appl. No. 10/842,716 [012P1]: Office Action dated Jul. 9, 2010. |
| U.S. Appl. No. 10/991,966 [032A]: Office Action dated Jul. 22, 2008. |
| U.S. Appl. No. 10/991,966 [032A]: Office Action dated Nov. 28, 2007. |
| U.S. Appl. No. 10/991,966, filed Nov. 17, 2004 granted Apr. 14, 2009 as U.S. Pat. No. 7,519,408 [032A]: Partial Electronic File History, including Office Actions dated Nov. 28, 2007, Apr. 15, 2008, Jul. 22, 2008, Nov. 20, 2008, and Jan. 13, 2009, and Responses filed Jan. 28, 2008, Apr. 23, 2008, May 28, 2008, Sep. 22, 2008 and Dec. 9, 2008. |
| U.S. Appl. No. 11/007,920 [029A]: Office Action dated Jun. 24, 2008. |
| U.S. Appl. No. 11/038,340 [024C1]: Office Action dated Feb. 2, 2010. |
| U.S. Appl. No. 11/038,340 [024C1]: Office Action dated Jan. 5, 2009. |
| U.S. Appl. No. 11/038,340 [024C1]: Office Action dated Jun. 7, 2010. |
| U.S. Appl. No. 11/038,340 [029C1]: Office Action dated Nov. 9, 2009. |
| U.S. Appl. No. 11/038,340 [024C1]: Office Action dated Jun. 17, 2008. |
| U.S. Appl. No. 11/038,340 [024C1]: Office Action dated May 19, 2009. |
| U.S. Appl. No. 11/077,739 [051A10]: Office Action dated Mar. 1, 2010. |
| U.S. Appl. No. 11/077,739 [051A10]: Office Action dated Jul. 21, 2009. |
| U.S. Appl. No. 11/077,739 [051A10]: Office Action dated Dec. 29, 2009. |
| U.S. Appl. No. 11/077,740 [051A11]: Office Action dated Jun. 1, 2007. |
| U.S. Appl. No. 11/077,740 [051A11]: Office Action dated Nov. 1, 2007. |
| U.S. Appl. No. 11/077,740 [051A11]: Office Action dated Feb. 7, 2008. |
| U.S. Appl. No. 11/077,740 [051A11]: Office Action dated Apr. 28, 2009. |
| U.S. Appl. No. 11/077,759 [050A]: Office Action dated Jul. 10, 2008. |
| U.S. Appl. No. 11/077,759 [050A]: Office Action dated May 26, 2009. |
| U.S. Appl. No. 11/077,759 [050A]: Office Action dated Mar. 31, 2008. |
| U.S. Appl. No. 11/077,765 [051A12]: Office Action dated Feb. 3, 2010. |
| U.S. Appl. No. 11/077,765 [051A12]: Office Action dated May 16, 2008. |
| U.S. Appl. No. 11/077,765 [051A12]: Office Action dated Sep. 19, 2008. |
| U.S. Appl. No. 11/077,765 [051A12]: Office Action dated Jan. 23, 2009. |
| U.S. Appl. No. 11/077,765 [051A12]: Office Action dated Dec. 31, 2007. |
| U.S. Appl. No. 11/157,365 [061A1]: Office Action dated Jan. 7, 2009. |
| U.S. Appl. No. 11/157,365 [061A1]: Office Action dated Jan. 21, 2010. |
| U.S. Appl. No. 11/157,365 [061A1]: Office Action dated Jun. 26, 2008. |
| U.S. Appl. No. 11/157,365 [061A1]: Office Action dated Jul. 21, 2009. |
| U.S. Appl. No. 11/028,672 [010D1]: Office Action dated Oct. 29, 2009. |
| U.S. Appl. No. 11/334,876 [061P2]: Office Action dated May 2, 2008. |
| U.S. Appl. No. 11/334,876 [061P2]: Office Action dated Oct. 4, 2006. |
| U.S. Appl. No. 11/334,876 [061P2]: Office Action dated Aug. 24, 2009. |
| U.S. Appl. No. 11/334,876 [061P2]: Office Action dated Sep. 25, 2007. |
| U.S. Appl. No. 11/334,876 [061P2]: Office Action dated Aug. 26, 2008. |
| U.S. Appl. No. 11/360,252 [061P3]: Office Action dated Jan. 29, 2009. |
| U.S. Appl. No. 11/360,252 [061P3]: Office Action dated Jun. 30, 2008. |
| U.S. Appl. No. 11/360,252 [061P3]: Office Action dated Jul. 23, 2009. |
| U.S. Appl. No. 11/360,819 [061P4]: Office Action dated Sep. 2, 2010. |
| U.S. Appl. No. 11/360,819 [061P4]: Office Action dated Apr. 7, 2010. |
| U.S. Appl. No. 11/360,819 [061P4]: Office Action dated Aug. 11, 2008. |
| U.S. Appl. No. 11/360,819 [061P4]: Office Action dated Dec. 26, 2008. |
| U.S. Appl. No. 11/360,819 [061P4]: Office Action dated Oct. 29, 2009. |
| U.S. Appl. No. 11/373,628 [053A]: Office Action dated Aug. 10, 2010. |
| U.S. Appl. No. 12/055,098 [106A]: Office Action dated Oct. 5, 2010. |
| U.S. Appl. No. 12/098,353 [024C1D2]: Office Action dated Aug. 26, 2008. |
| U.S. Appl. No. 12/098,353, filed Apr. 4, 2008 [024C1D2]: Partial Electronic File History, including Office Actions dated Aug. 26, 2010 and May 4, 2010, and Applicant Responses filed Nov. 24, 2001 and Jun. 3, 2011. |
| U.S. Appl. No. 12/098,359 [024C1D1]: Office Action dated Jul. 7, 2010. |
| U.S. Appl. No. 12/102,654 [016D1]: Office Action dated Mar. 10, 2010. |
| U.S. Appl. No. 12/102,745 [016D3]: Office Action dated Dec. 23, 2008. |
| U.S. Appl. No. 12/133,738 [094A2]: Office Action dated Sep. 10, 2010. |
| U.S. Appl. No. 12/133,761 [094A3]: Office Action dated Sep. 7, 2010. |
| U.S. Appl. No. 12/182,008 [032D2]: Office Action dated Aug. 24, 2010. |
| U.S. Appl. No. 12/182,008, filed Jul. 29, 2008 [032D2]: Partial Electronic File History, including Office Actions dated May 3, 2010, Aug. 24, 2010, Jan. 25, 2011, Apr. 29, 2011 and Applicant Responses filed Jun. 2, 2010, Nov. 5, 2010, Mar. 23, 2011 and Jul. 28, 2011. |
| U.S. Appl. No. 12/182,073 [032C1]: Office Action dated Jun. 28, 2010. |
| U.S. Appl. No. 12/182,073, filed Jul. 29, 2008: Partial Electronic File History, Office Actions dated Jun. 28, 2010, Oct. 28, 2010, Jan. 14, 2011, and responses filed Oct. 9, 2009, Aug. 10, 2010, Dec. 22, 2010 and Feb. 28, 2011. |
| U.S. Appl. No. 12/182,083 [032D3]: Office Action dated Jun. 24, 2010. |
| U.S. Appl. No. 12/182,083, filed Jul. 29, 2008, granted Apr. 19, 2011 as U.S. Pat. No. 7,927,274 [032D3]: Partial Electronic File History, including Office Actions dated Jun. 24, 2010 and Oct. 20, 2010, and Applicant Responses filed Aug. 4, 2010 and Sep. 30, 2010. |
| U.S. Appl. No. 12/353,787 [027D1]: Office Action dated Aug. 6, 2010. |
| U.S. Appl. No. 12/353,799 [027D2]: Office Action dated Aug. 6, 2010. |
| U.S. Appl. No. 12/364,786 [061P2C3]: Office Action dated Jul. 29, 2010. |
| U.S. Appl. No. 12/536,852 [037D1]: Office Action dated Oct. 18, 2010. |
| U.S. Appl. No. 12/536,852 [037D1]: Office Action dated Jun. 25, 2010. |
| U.S. Appl. No. 12/579,385 [027C4]: Office Action dated Aug. 23, 2010. |
| U.S. Appl. No. 12/619,502 [038C1]: Office Action dated Sep. 7, 2010. |
| U.S. Appl. No. 12/731,965, filed Mar. 25, 2010 [032C1C1]: Partial Electronic File History, including Office Action dated Jun. 20, 2011 and Reponse filed Oct. 20, 2011. |
| U.S. Appl. No. 12/756,205, filed Sep. 23, 2009 [032D1D1]: Partial Electronic File History, including Office Action dated Jun. 13, 2011 and reponse filed Sep. 16, 2011. |
| Aalders, et al., “Development of a Wearable Glucose Sensor; Studies in Healthy Volunteers and in Diabetic Patients,” The International Journal of Artificial Organs, 1991, vol. 14, No. 2, pp. 102-108. |
| Abe, et al., “Characterization of Glucose Microsensors for Intracellular Measurements,” Analytical Chemistry, 1992, vol. 64, No. 18, pp. 2160-2163. |
| Baker D.A., et al., “Dynamic Concentration Challenges for Biosensor Characterization,” Biosensors & Bioelectronics, vol. 8, 1993, pp. 433-441. |
| Bindra D.S., et al., “Pulsed Amperometric Detection of Glucose in Biological Fluids at a Surface-Modified Gold Electrode,” Analytical Chemistry, vol. 61 (22), Nov. 15, 1989, pp. 2566-2570. |
| File History of U.S. Appl. No. 09/447,227, filed Nov. 22, 1999, 1184 pages. |
| File History of U.S. Appl. No. 10/838,658, filed May 3, 2004, 748 pages. |
| File History of U.S. Appl. No. 10/838,909, filed May 3, 2004, 356 pages. |
| File History of U.S. Appl. No. 10/838,912, filed May 3, 2004, 1288 pages. |
| File History of U.S. Appl. No. 10/885,476, filed Jul. 6, 2004, 226 pages. |
| File History of U.S. Appl. No. 10/896,312, filed Jul. 20, 2004, 237 pages. |
| File History of U.S. Appl. No. 12/133,738, filed Jun. 5, 2008, 557 pages. |
| File History of U.S. Appl. No. 12/133,761, filed Jun. 5, 2008, 585 pages. |
| File History of U.S. Appl. No. 12/133,786, filed Jun. 5, 2008, 814 pages. |
| File History of U.S. Appl. No. 12/536,852, filed Aug. 6, 2009, 480 pages. |
| File History of U.S. Appl. No. 12/579,385, filed Oct. 14, 2009, 558 pages. |
| Kiechle F.L., “The Impact of Continuous Glucose Monitoring on Hospital Point-of-Care Testing Programs,” Diabetes Technology and Therapeutics, vol. 3 (4), 2001, pp. 647-649. |
| Murphy S.M., et al., “Polymer Membranes in Clinical Sensor Applications, II. The Design and Fabrication of Permselective Hydrogels for Electrochemical Devices,” Biomaterials, 1992, vol. 13 (14), pp. 979-990. |
| Office Action for European Application No. 05723951.9, dated Jan. 28, 2011, 6 pages. |
| Office Action for U.S. Appl. No. 10/896,772, dated Dec. 14, 2005, 10 pages. |
| Office Action for U.S. Appl. No. 10/896,772, dated Jan. 11, 2005, 16 pages. |
| Office Action for U.S. Appl. No. 10/896,772, dated Jul. 19, 2005, 17 pages. |
| Office Action for U.S. Appl. No. 10/896,772, dated May 22, 2006, 31 pages. |
| Office Action for U.S. Appl. No. 11/007,635, dated Jan. 27, 2006, 9 pages. |
| Office Action for U.S. Appl. No. 11/034,344, dated Jan. 15, 2008, 5 pages. |
| Office Action for U.S. Appl. No. 11/077,714, dated Apr. 10, 2007, 16 pages. |
| Office Action for U.S. Appl. No. 11/077,714, dated Apr. 16, 2009, 12 pages. |
| Office Action for U.S. Appl. No. 11/077,714, dated Dec. 31, 2009, 8 pages. |
| Office Action for U.S. Appl. No. 11/077,714, dated Jan. 10, 2008, 18 pages. |
| Office Action for U.S. Appl. No. 11/077,714, dated Jan. 27, 2010, 9 pages. |
| Office Action for U.S. Appl. No. 11/077,714, dated Jul. 27, 2007, 13 pages. |
| Office Action for U.S. Appl. No. 11/077,714, dated Oct. 11, 2006, 9 pages. |
| Office Action for U.S. Appl. No. 11/077,714, dated Sep. 16, 2008, 16 pages. |
| Office Action for U.S. Appl. No. 11/077,759, dated May 17, 2007, 13 pages. |
| Office Action for U.S. Appl. No. 11/078,072, dated Feb. 18, 2010, 6 pages. |
| Office Action for U.S. Appl. No. 11/078,072, dated Jun. 10, 2010, 8 pages. |
| Office Action for U.S. Appl. No. 11/078,072, dated Sep. 2, 2009, 13 pages. |
| Office Action for U.S. Appl. No. 11/078,232, dated Apr. 27, 2010, 18 pages. |
| Office Action for U.S. Appl. No. 11/078,232, dated Jan. 5, 2010, 15 pages. |
| Office Action for U.S. Appl. No. 11/078,232, dated Jul. 21, 2009, 13 pages. |
| Office Action for U.S. Appl. No. 11/078,232, dated Mar. 5, 2009, 14 pages. |
| Office Action for U.S. Appl. No. 11/078,232, dated May 5, 2008, 21 pages. |
| Office Action for U.S. Appl. No. 11/078,232, dated Nov. 12, 2008, 28 pages. |
| Office Action for U.S. Appl. No. 11/333,837, dated Apr. 12, 2010, 10 pages. |
| Office Action for U.S. Appl. No. 11/333,837, dated Jul. 2, 2010, 7 pages. |
| Office Action for U.S. Appl. No. 11/333,837, dated Jun. 29, 2009, 13 pages. |
| Office Action for U.S. Appl. No. 11/333,837, dated Nov. 28, 2008, 11 pages. |
| Office Action for U.S. Appl. No. 12/102,654, dated Jul. 30, 2009, 9 pages. |
| Office Action for U.S. Appl. No. 12/102,729, dated Jul. 7, 2009, 7 pages. |
| Office Action for U.S. Appl. No. 12/113,508, dated Feb. 23, 2010, 9 pages. |
| Office Action for U.S. Appl. No. 12/113,724, dated Jun. 24, 2010, 12 pages. |
| Office Action for U.S. Appl. No. 12/133,786, dated Sep. 8, 2010, 12 pages. |
| Office Action for U.S. Appl. No. 12/264,160, dated Jun. 3, 2010, 5 pages. |
| Pickup J.C., et al., “Developing Glucose Sensors for In Vivo Use,” Elsevier Science Publishers Ltd (UK), Tibtech, vol. 11, 1993, pp. 285-291. |
| Selam J.L., “Management of Diabetes with Glucose Sensors and Implantable Insulin Pumps,” From the Dream of the 60s to the Realities of the 90s, Asaio Journal 1997, vol. 43, pp. 137-142. |
| Shichiri M., et al., “Glycaemic Control in Pancreatectomized Dogs with a Wearable Artificial Endocrine Pancreas,” Diabetologia, vol. 24, 1983, pp. 179-184. |
| Shichiri M., et al., “Membrane Design for Extending the Long-Life of an Implantable Glucose Sensor,” Diabetes Nutrition & Metabolism, vol. 2 (4), 1989, pp. 309-313. |
| Sternberg R., et al., “Study and Development of Multilayer Needle-type Enzyme Based Glucose Microsensors,” Biosensors, vol. 4, 1988, pp. 27-40. |
| U.S. Appl. No. 10/950,226, filed Sep. 23, 2004, 24 pages. |
| U.S. Appl. No. 11/618,706, filed Dec. 29, 2006, 35 pages. |
| U.S. Pat. No. 7,530,950, May 12, 2009, Brister et al. (withdrawn). |
| Number | Date | Country | |
|---|---|---|---|
| 20170055889 A1 | Mar 2017 | US |
| Number | Date | Country | |
|---|---|---|---|
| 60614683 | Sep 2004 | US | |
| 60587787 | Jul 2004 | US | |
| 60523840 | Nov 2003 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 12731965 | Mar 2010 | US |
| Child | 15347687 | US | |
| Parent | 12182073 | Jul 2008 | US |
| Child | 12731965 | US | |
| Parent | 10991966 | Nov 2004 | US |
| Child | 12182073 | US |
