Abstract: A biosensor including an external surface, and an accessory material in close proximity to the external surface. The accessory material includes a coating containing a hydrophilic material and/or a fiber modified to deliver a therapeutic agent. The biosensor modifies a biological response to the biosensor upon contact with a tissue, such as upon implantation into the skin of a subject, thereby reducing biofouling, inflammation and other undesirable tissue responses that interfere with biosensor performance. The biosensor can be any biocompatible sensor, suitable for short- or long-term use. Preferably, the biosensor is an enzymatic or electrochemical sensor, such as a glucose sensor. Also provided are a method of producing a biosensor and a method of delivering a biologically active substance to a subject.

Abstract: Methods and apparatuses for electrically connecting a medical glucose monitor to a glucose sensor set, as well as for testing the operation of the glucose monitor, monitor cable and glucose sensor set are provided. In one embodiment, an electric cable comprises a cable member, a first connector and a second connector. The cable member in turn comprises at least one insulated conductor, a conductive shielding layer disposed around the at least one insulated conductor; and an insulating layer disposed around the conductive shielding layer. A glucose monitoring system test plug provides for a releasable electrical connection with the electric cable. In one embodiment, the test plug comprises a housing and a fitting affixed thereto which is adapted to electrically couple the test plug with the electric cable.

Abstract: A system to assist an individual in developing a therapy in diabetes treatment of a patient includes a user interface control module, a simulation engine, a charting and display module. The user interface control module receives an input related to the patient and captures a current time of the simulation. The simulation engine receives the input, generates a plurality of blood glucose readings for the patient up to the current time of the simulation based on the input, and to transfers the plurality of blood glucose readings. The charting and display module receives the plurality of blood glucose readings and display the plurality of blood glucose readings. The simulation engine receives patient parameters from a patient parameter library based on a selected patient model.

Abstract: A multilayer circuit substrate for multi-chip modules or hybrid circuits includes a dielectric base substrate, conductors formed on the base substrate and a vacuum deposited dielectric thin film formed over the conductors and the base substrate. The vacuum deposited dielectric thin film is patterned using sacrificial structures formed by shadow mask techniques. Substrates formed in this manner enable significant increases in interconnect density and significant reduction of over-all substrate thickness.

Abstract: A drive mechanism for delivery of infusion medium. A coil surrounds a piston channel. An armature is located adjacent the coil. The armature is moveable toward a forward position in response to the electromagnetic field produced by activation of the coil. A piston located within the piston channel is moveable within the channel to a forward position in response to movement of the armature. The armature and piston are moved toward a retracted position when the coil is not energized. In the retracted position, a piston chamber formed between the piston and a valve member is filled with infusion medium. As the piston is moved to its forward position, piston chamber volume is reduced and pressure within the piston chamber increases and moves the valve member into an open position. Medium from the piston chamber is then discharged into an outlet chamber.

Abstract: An introducer is provided for introducing a cannula for subcutaneous administration of fluid into a patient. The fluid is generally a medication, for example, insulin. The cannula is in fluid communication with a fluid passageway surrounded by a projection on the cannula housing that includes one or more rail-like extensions acting as connection guides. The introducer includes an introducer needle and one or more guide arms that slide over the rail-like extensions to guide the needle into the self-sealing septum. The introducer includes one or more locking arms, with barbs at the end, to connect with one or more recesses that are provided in the cannula housing.

Abstract: A system and method for multiple antennas on a single core. The system may include a first core, a first winding wound about the first core for transmitting/receiving electromagnetic signals, and a second winding for transmitting/receiving electromagnetic signals wound about the first core and the first winding. The first winding and the second winding may be wound such that a direction of a first magnetic field generated by the first winding is different than a direction of a second magnetic field generated by the second winding. The system may also include activation circuitry connected to the first winding and the second winding. The activation circuitry may activate the first winding separately from the second winding. The system may be expanded to three or more coils/antennas disposed on a single core.

Abstract: An infusion system for infusing a liquid into a body includes an external infusion device and a remote commander. The external infusion device includes a housing, a receiver, a processor and an indication device. The receiver is coupled to the housing and for receiving remotely generated commands. The processor is coupled to the housing and the receiver to receive remotely generated commands and to control the external infusion device in accordance with the commands. The indication device indicates when a command has been received and indicates when the command is being utilized to control the external infusion device so that the external infusion device is capable of being concealed from view when being remotely commanded. The remote commander includes a commander housing, a keypad for transmitting commands, and a transmitter for transmitting commands to the receiver of the external infusion device.

Abstract: A telemetered characteristic monitor system includes a remotely located data receiving device, a sensor for producing signal indicative of a characteristic of a user, and a transmitter device. The transmitter device includes a housing, a sensor connector, a processor, and a transmitter. The transmitter receives the signals from the sensor and Tirelessly transmits the processed signals to the remotely located data receiving device. The processor coupled to the sensor processes the signals from the sensor for transmission to the remotely located data receiving device. The data receiving device may be a characteristic monitor, a data receiver that provides data to another device, an RF programmer for a medical device, a medication delivery device (such as an infusion pump), or the like.

Abstract: A pump for dispensing a fluid from a reservoir provides a drive system seal within the pump. The pump includes a reservoir cavity adapted to receive the reservoir, and a drive system. The pump also includes at least one plunger slider having one end coupled to the drive system and the other end coupled to the reservoir. The plunger slider is adapted to translate from a retracted position to an extended position to dispense the fluid from the reservoir in response to actuation by the drive system. The pump further includes a sealing ring mounted around the plunger slider, and a spring disposed within the sealing ring. The sealing ring with the spring disposed therein is adapted to allow the plunger slider to translate from the retracted position to the extended position, and to prevent entry of fluid from the reservoir cavity into the drive system.

Abstract: Apparatuses and methods for pumping fluid are disclosed. An exemplary apparatus is a miniature pump that includes a shape memory wire that obtains a plastic condition below a transformation temperature and has a memorized shape such that the shape memory wire produces a work stroke by returning to the memorize shape at least at the transformation temperature. A spring biased against the shape memory wire is deflected by the work stroke to deform the shape memory wire from the memorized shape below the transformation temperature. A fluid pump is coupled to the shape memory wire and driven by the biased spring and shape memory wire to produce a fluid flow. The miniature pump can be incorporated into a self-contained infusion device in the form of a compact self-adhesive patch including a fluid reservoir, control electronics and power supply that is place directly at the infusion site of a user.

Abstract: Fluorescent biosensor molecules, fluorescent biosensors and systems, as well as methods of making and using these biosensor molecules and systems are described. These biosensor molecules address the problem of obtaining fluorescence emission at wavelengths greater than about 500 nm. Biosensor molecules generally include an (1) an acridine-based fluorophore, (2) a linker moiety and (3) a boronate substrate recognition/binding moiety, which binds polyhydroxylate analytes, such as glucose. These biosensor molecules further include a “switch” element that is drawn from the electronic interactions among these submolecular components. This fluorescent switch is generally “off” in the absence of bound polyhydroxylate analyte and is generally “on” in the presence of bound polyhydroxylate analyte. Thus, the reversible binding of a polyhydroxylate analyte essentially turns the fluorescent switch “on” and “off”.

Abstract: A method of calibrating glucose monitor data includes collecting the glucose monitor data over a period of time at predetermined intervals. It also includes obtaining at least two reference glucose values from a reference source that temporally correspond with the glucose monitor data obtained at the predetermined intervals. Also included is calculating the calibration characteristics using the reference glucose values and the corresponding glucose monitor data to regress the obtained glucose monitor data. And calibrating the obtained glucose monitor data using the calibration characteristics is included. In preferred embodiments, the reference source is a blood glucose meter, and the at least two reference glucose values are obtained from blood tests. In additional embodiments, the calculation of the calibration characteristics is obtained using linear regression and in particular embodiments, least squares linear regression.

Abstract: An infusion system for infusing a liquid into a body includes an external infusion device and a remote commander. The external infusion device includes a housing, a receiver, a processor and an indication device. The receiver is coupled to the housing and for receiving remotely generated commands. The processor is coupled to the housing and the receiver to receive remotely generated commands and to control the external infusion device in accordance with the commands. The indication device indicates when a command has been received and indicates when the command is being utilized to control the external infusion device so that the external infusion device is capable of being concealed from view when being remotely commanded. The remote commander includes a commander housing, a keypad for transmitting commands, and a transmitter for transmitting commands to the receiver of the external infusion device.

Abstract: A method and system for non-vascular sensor implantation. An implant unit is implanted in an area of a body and a foreign body capsule is allowed to form around the area of the implant unit. The sensor may be directed into a body cavity such as, for example, the peritoneal space, subcutaneous tissues, the foreign body capsule, or other area of the body. A subcutaneous area of the body may be tunneled to place the sensor. The system may include an implant unit such as, for example, for delivering drug to a human body and a sensor for detecting a physiological parameter. The sensor may be separate from and connectable to the implant unit and may be placed in a non-vascular area of the human body.

Abstract: Apparatuses and methods for medical monitoring physiological characteristics values such as blood glucose levels for the treatment of diabetes, are presented. The apparatuses and methods provide dynamic glucose monitoring functions that perform predictive analysis to anticipate harmful conditions, such as glucose crash and hyperglycemic incidents for a patient. The dynamic functions can also be used to maximize athletic performance and warn of inadequate nocturnal basal rate. Other aspects include advanced alarm and reminder functions, as well as advanced data presentation tools to further facilitate convenient and efficient management of various physiological conditions.

Abstract: An implanted medical device (e.g. infusion pump) and external device communicate with one another via telemetry wherein messages are transmitted under a robust communication protocol. The communication protocol gives enhanced assurance concerning the integrity of messages that impact medical operations of the implantable device. Messages are transmitted using a multipart format that includes a preamble, a frame sync, a telemetry ID, data, and a validation code. The data portion of the message includes an op-code that dictates various other elements that form part of the message. The data portion may also include additional elements such as sequence numbers, bolus numbers, and duplicate data elements. A telemetry ID for the transmitting device may be implicitly embedded in the message as part of the validation code that is sent with the message and that must be pre-known by the receiver to confirm the integrity of the received message.

Abstract: A apparatus and method for cleaning a sensor tip of an implantable sensor includes a flush sleeve directed towards the sensor tip, a fluid conduit in fluid communication with the flush sleeve, where fluid injected into a first end of a flush sleeve surrounding the sensor sprays off the sensor tip through at least one orifice located at the second end of the flush sleeve. The first end of the flush sleeve contains a fluid conduit and a septum, where a needle is used to pierce the septum to inject the fluid into the fluid conduit.

Abstract: A sensor and method of making the same for implantation in a body that includes a substrate with notches cut in the substrate to form a necked down region in the substrate; and at least one sensor electrode formed from one or more conductive layers. Preferably, the thickness of the substrate ranges from approximately 25? to 350?, but the thickness of the substrate can range from 5? to 750?. The sensor may be incorporated in to a sensor assembly includes a slotted needle having a slot. The notches creating the necked down region allow the substrate to slide into the slotted needle, which that has the slot narrow enough to permit passage of the necked down region. However, a non-necked down region of the substrate is prevented from pulling out of the slotted needle through the slot. The slot of the slotted needle may also permit the necked down region of the substrate to slide down the slot.

Abstract: An insertion set for insertion through the skin of a patient includes at least one piercing member adapted to be secured to an insertion device and a set housing to be removable from the insertion device while maintaining installation of the insertion set. At least a portion of the at least one piercing member is insertable through the skin. The set housing is coupled to the at least one piercing member and is adapted so that it is shaped to fit an insertion device to orient the at least one piercing member for placement through the skin of at least a portion of the at least one piercing member at a predetermined angle relative to the skin to install the insertion set. The at least one piercing member is adapted to be retainable by the insertion device during removal from the insertion set.