An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte. The analyte monitor may also be part of a drug delivery system to alter the level of the analyte based on the data obtained using the sensor.

Analyte Monitoring Device And Methods Of Use

A small diameter flexible electrode designed for subcutaneous in vivo amperometric monitoring of glucose is described. The electrode is designed to allow “one-point” in vivo calibration, i.e., to have zero output current at zero glucose concentration, even in the presence of other electroreactive species of serum or blood. The electrode is preferably three or four-layered, with the layers serially deposited within a recess upon the tip of a polyamide insulated gold wire. A first glucose concentration-to-current transducing layer is overcoated with an electrically insulating and glucose flux limiting layer (second layer) on which, optionally, an immobilized interference-eliminating horseradish peroxidase based film is deposited (third layer). An outer (fourth) layer is biocompatible.

Subcutaneous glucose electrode

Microneedle devices are provided for transport of therapeutic and biological molecules across tissue barriers and for use as microflameholders. In a preferred embodiment for transport across tissue, the microneedles are formed of a biodegradable polymer. Methods of making these devices, which can include hollow and/or porous microneedles, are also provided. A preferred method for making a microneedle includes forming a micromold having sidewalls which define the outer surface of the microneedle, electroplating the sidewalls to form the hollow microneedle, and then removing the micromold from the microneedle. In a preferred method of use, the microneedle device is used to deliver fluid material into or across a biological barrier from one or more chambers in fluid connection with at least one of the microneedles. The device preferably further includes a means for controlling the flow of material through the microneedles. Representative examples of these means include the use of permeable membranes, fracturable impermeable membranes, valves, and pumps.

Microneedle devices and methods of manufacture and use thereof

A sensor designed to determine the amount and concentration of analyte in a sample having a volume of less than about 1 μL. The sensor has a working electrode coated with a non-leachable redox mediator. The redox mediator acts as an electron transfer agent between the analyte and the electrode. In addition, a second electron transfer agent, such as an enzyme, can be added to facilitate the electrooxidation or electroreduction of the analyte. The redox mediator is typically a redox compound bound to a polymer. The preferred redox mediators are air-oxidizable. The amount of analyte can be determined by coulometry. One particular coulometric technique includes the measurement of the current between the working electrode and a counter or reference electrode at two or more times. The charge passed by this current to or from the analyte is correlated with the amount of analyte in the sample. Other electrochemical detection methods, such as amperometric, voltammetric, and potentiometric techniques, can also be used. The invention can be used to determine the concentration of a biomolecule, such as glucose or lactate, in a biological fluid, such as blood or serum. An enzyme capable of catalyzing the electrooxidation or electroreduction of the biomolecule is provided as a second electron transfer agent.

Small volume in vitro analyte sensor

Microneedle devices and methods of use thereof are provided for the enhanced transport of molecules, including drugs and biological molecules, across tissue by improving the interaction of microneedles and a deformable, elastic biological barrier, such as human skin. The devices and methods act to (1) limit the elasticity, (2) adapt to the elasticity, (3) utilize alternate ways of creating the holes for the microneedles to penetrate the biological barrier, other than the simply direct pressure of the microneedle substrate to the barrier surface, or (4) any combination of these methods. In preferred embodiments for limiting the elasticity of skin, the microneedle device includes features suitable for stretching, pulling, or pinching the skin to present a more rigid, less deformable, surface in the area to which the microneedles are applied (i.e. penetrate). In a preferred embodiments for adapting the device to the elasticity of skin, the device comprising one or more extensions interposed between the substrate and the base end of at least a portion of the microneedles.

Devices and methods for enhanced microneedle penetration of biological barriers

The electrode array is a device for making multiple electrical contacts with cellular tissue or organs. The electrode array includes a base (1), a two dimensional array of conducting protuberances (2) arising from the base and serving as electrodes, and conductors (3) embedded onto the base and connected to such protuberances for transmitting electrical signals to and/or from the protuberances. The protuberances may also include an insulating layer (15) which covers either the entire protuberance or which leaves the tips exposed for making focused electrical contact. Electrode arrays may be used used singly or in combination with a second electrode array so as to form a sandwich around a target tissue. The sandwich electrode array (16, 17) may employ indexing cones for aligning the opposing electrode arrays and for limiting their vertical proximity. The conductors of the electrode array may be electronically connected or coupled to processing circuitry which amplifies and analyzes the signal received from the tissue and/or which generates signals which are sent to the target tissue and possibly coordinates the generated signals with signals which originate with the tissue.

Electrode array for use in connection with a living body and method of manufacture

A very small electrode array is disclosed, having numerous, small, sharp, conductive protuberances (needles) which penetrate nerves, organs, muscle or other body part for sensing the electrical activity therein or to provide electrical stimulation. The protuberances are carried on a base and there is included electrical conductors connecting the protuberances to terminals, such as bonding pads, for connection to other electrical circuits. Thus, a method of connecting to living tissue is disclosed. Also, a method of manufacture of an electrode array and associated circuitry is disclosed.

Method of making an electrode array

The electrode array is a device for making multiple electrical contacts with cellular tissue or organs. The electrode array includes a base (1), a two dimensional array of conducting protuberances (2) arising from the base and serving as electrodes, and conductors (3) embedded onto the base and connected to such protuberances for transmitting electrical signals to and/or from the protuberances. The protuberances may also include an insulating layer (15) which covers either the entire protuberance or which leaves the tips exposed for making focused electrical contact. Electrode arrays may be used singly or in combination with a second electrode array so as to form a sandwich around a target tissue. The sandwich electrode array (16, 17) may employ indexing cones for aligning the opposing electrode arrays and for limiting their vertical proximity. The conductors of the electrode array may be electronically connected or coupled to processing circuitry which amplifies and analyzes the signal received from the tissue and/or which generates signals which are sent to the target tissue and possibly coordinates the generated signals with signals which originate with the tissue.

Electrode array and method of manufacture.

Le reseau d'electrodes est un dispositif permettant de realiser des contacts electriques multiples avec des organes ou tissus cellulaires. Le reseau d'electrodes comprend une base (1), un reseau bidimensionnel de protuberances conductrices (2) faisant saillie depuis la base et servant d'electrodes, et des conducteurs (3) noyes sur la base et connectes a ces protuberances pour transmettre des signaux electriques vers les protuberances et/ou provenant des protuberances. Les protuberances peuvent egalement inclure une couche isolante (15) qui soit recouvre toute la protuberance soit laisse les pointes exposees pour realiser un contact electrique focalise. Les reseaux d'electrodes peuvent etre utilises seuls ou en combinaison avec un second reseau d'electrodes de maniere a former un sandwich autour d'un tissu cible. Le reseau d'electrodes sandwich (16, 17) peut utiliser des cones d'indexation pour aligner les reseaux d'electrodes opposes et pour limiter leur proximite verticale. Les conducteurs du reseau d'electrodes peuvent etre connectes ou couples electroniquement a un circuit de traitement qui amplifie et analyse le signal recu du tissu et/ou qui genere des signaux lesquels sont envoyes au tissu cible, ce circuit de traitement pouvant aussi assurer une coordination entre les signaux generes et les signaux emanant du tissu.

Charles L. Byers

Papers

Electrode array for use in connection with a living body and method of manufacture

Method of making an electrode array

Electrode array and method of manufacture.

Reseau d'electrodes et procede de fabrication