Abstract: A glucose sensor package system that includes a glucose sensor and a protective package that indicates exposure to temperature changes to indicate proper temperature control. Also covered are methods of transporting and sterilizing the package. In addition, glucose sensors directed to various sizing and positioning of the electrodes on the glucose sensor are covered.

Abstract: An improved medication infusion set is provided of the type having a soft cannula for subcutaneous delivery of a selected medication to a patient. The infusion set comprises a cannula housing having a soft cannula protruding therefrom and a self-sealing septum mounted at an upstream end of the cannula. The cannula housing is initially assembled with an insertion hub having an elongated insertion needle extending through the septum and cannula for transcutaneously placing the cannula followed by separation of the insertion hub from the cannula housing. An infusion hub is then assembled with the cannula housing and includes a short infusion needle for coupling the cannula with the selected medication supplied from a source via a length of infusion tubing.

Abstract: Embodiments of implantable infusion pumps are provided that use a process of converting a first substance to a second gaseous substance (e.g. by electrolysis) to provide a motivating force to expel a desired fluid (e.g. drug or medication) from the pump into the body of a patient. An expandable sack may be provided around a gas producing electrolytic cell, such that as the gas expands it displaces a portion of the volume originally allocated to the desired fluid, and thereby forces the fluid from the pump. Pumps may be provided with a double septum to allow refilling of the desired fluid while simultaneously allowing removal of the generated gas from the system while using a single needle. Recharging of pump batteries may occur by direct electrical conduction through one or more needles and/or by r.f. energy transfer. Programming of the pump may occur by way of conductive paths provided by one or more needles or by means of r.f. transfer.

Abstract: Embodiments of the invention provide polymer coated implantable medical devices having a bioactive material posited in or on at least a portion of the coating layer, wherein the coating layer provides for the controlled release of the bioactive material from the coating layer. Preferably, the medical device is an intravascular stent.

Abstract: Improved implantable monitoring systems suitable for long-term in vivo use to measure the concentration of one or more prescribed substances, such as glucose, are described herein. In particular, an implantable enzyme-based glucose monitoring system is described that includes at least one of the following: means for replenishing the enzyme solution as it is consumed by the enzymatic reaction; means for replenishing the electrolyte solution bathing the electrode assembly; and microprocessing means proximal the electrode assembly. In preferred embodiments, a microprocessor assembly is hermetically associated with the substrate to which the electrode assembly is affixed. Further, the monitoring systems employ one or more reservoir systems in fluid communication with enzyme and electrolyte chambers wherein the enzyme and electrolyte solutions are used.

Abstract: In a fluid delivery system for delivering a fluid into an individual's body, a leak detection system indicates that the fluid has leaked outside a normal fluid path of the fluid delivery system, such as near an infusion site or a fluid-filled reservoir. Preferably, the leak detection system includes a chemical positioned near the infusion site that reacts with preservatives in the leaking fluid to generate a highly visible, brightly colored, chemical complex. Alternatively, mechanical, electro-optical, electrochemical, electrical or other chemical systems may be used to detect the presence of fluid that is leaking near the infusion site. Further, the leak detection systems may be used to detect the presence of fluid that is leaking from or near other locations within the fluid delivery system, such as on or near a fluid-filled reservoir, or a flexible tube coupled between the reservoir and the infusion site.

Abstract: A communication station is for use with a medical device (such as an infusion pump) and a processing device (such as a computer). The communication station includes a housing, a medical device interface coupled to the housing, a processing device interface coupled to the housing and a processor coupled to the housing. The device interface interfaces with the medical device, and the processing device interface interfaces with the processing device. The processor provides a communication path between the medical device and the processing device such that programming and instructions may be communicated from the processing device to the medical device and data may be transferred from the medical device to the processing device. The communication station may be combined with a system that is capable of generating reports either locally or remotely. In addition, the medical device interface may be a cradle that is configurable to attach to different shaped medical devices.

Abstract: A transfer guard for use by an individual for transferring contents from a supply container into a receiver container includes a supply adapter, a receiver adapter, a support structure and a fluid conducting element. The supply adapter connects the supply container to the transfer guard, and the receiver adapter connects the receiver container to the transfer guard. The support structure couples the supply adapter with the receiver adapter, and supports the fluid conducting element which, passes through the supply adapter and the receiver adapter. The fluid conducting element provides a passage for the contents to transfer from the supply container into the receiver container. The fluid conducting element also includes at least one pointed end that is substantially protected by the transfer guard from contact with the individual.

Abstract: An occlusion detection system detects an occlusion in a fluid path of an infusion pump. The infusion pump is for delivering fluid to a user. The infusion pump includes a housing, a motor, a reservoir, one or more drive train components, a sensor, and an electronics system. The motor is contained within the housing. The reservoir contains the fluid to be delivered. The one or more drive train components react to stimulus from the motor to force the fluid from the reservoir into the user. The sensor is positioned to measure a parameter associated with the motor or a drive train component, and the sensor produces three or more output levels across a range of measurements. The electronics system processes the senor output levels to declare when an occlusion exists.

Abstract: A selectively protected electrical system includes or operates with a power source, a load, a power driver circuit for controllably transferring power from the power source to the load, the power driver circuit being encapsulated in a potting material, and a controller for enabling and disabling the power driver circuit, the controller being un-encapsulated by the potting material. If a contaminant induced electrical fault occurs in the selectively protected electrical system, the electrical fault is more likely to occur in the un-encapsulated controller, such that the selectively protected electrical system is disabled. The contaminant is inhibited from contacting and inducing an electrical fault in the power driver circuit, thus providing for a controlled failure of the selectively protected electrical system.

Abstract: A method of making a sensor includes the steps of providing a preformed self-supporting flexible substrate; sputter-depositing a metal layer on the substrate; etching the sputter-deposited metal layers to form a sensor electrode having a proximal segment and a distal segment; plating a metal layer on the sensor electrode; and separating the sensor electrode and at least a portion of the substrate underlying the sensor electrode from the remainder of the substrate. Sensors prepared according to the inventive methods, and sensor sets including the sensors, are also provided.

Abstract: An implantable enzyme-based monitoring system suitable for long term in vivo use to measure the concentration of prescribed substances such as glucose is provided. In one embodiment, the implantable enzyme-based monitoring system includes at least one sensor assembly, an outer membrane surrounding the sensor assembly and having a window therein, and a polymeric window cover affixed to the outer membrane and covering the window. Preferably, the outer membrane of the monitoring system is silicone and the window cover is a polymer of 2-hydroxyethyl methacrylate (HEMA), N,N,-dimethylaminoethyl methacrylate (DMAEMA) and methacrylic acid (MA). Also provided herein is an implantable enzyme-based monitoring system having at least one sensor assembly, an outer membrane surrounding the sensor assembly and a coating affixed to the exterior surface of the outer membrane, wherein the coating resists blood coagulation and protein binding to the exterior surface of the outer membrane.

Abstract: Provided is an infusion cannula modified to incorporate one of more medicinal agents. The infusion cannula has a tube having an inner lumen and an external surface, and is made of a flexible, biologically compatible elastomeric material, with a coating adhered to the external surface of the tube. The coating contains a medicinal agent in a polymer matrix. Preferably, the polymer is capable of sustained release of the medicinal agent. The infusion cannula can be produced by coating a tube with a medicinal agent in a polymer matrix. In some embodiments, the coating involves dipping the tube into the polymer matrix, or spraying or painting the polymer matrix onto the tube. Additionally provided is a method for infusing a substance into a subject by inserting the cannula into subcutaneous tissue of the subject and delivering the substance into the cannula, thereby infusing the substance into the subject through the cannula.

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: A protective, biocompatible coating or encapsulation material protects and insulates a component or device intended to be implanted in living tissue. The coating or encapsulation material comprises a thin layer or layers of alumina, zerconia, or other ceramic, less than 25 microns thick, e.g., 5-10 microns thick. The alumina layer(s) may be applied at relatively low temperature. Once applied, the layer provides excellent hermeticity, and prevents electrical leakage. Even though very thin, the alumina layer retains excellent insulating characteristics. In one embodiment, an alumina layer less than about 6 microns thick provides an insulative coating that exhibits less than 10 pA of leakage current over an area 75 mils by 25 mils area while soaking in a saline solution at temperatures up to 80° C. over a three month period.

Abstract: Stabilizing catheters for delivery of one or more protein drugs to a patient. The stabilizing catheter embodiments of the invention maintain or preserve a biologically/pharmacologically active form of the protein drug for delivery to a site within the body. Particular embodiments include a tubing layered with a hydrophilic and mobile polymer that aids in the maintenance or preservation of an active conformer of the protein drug. These embodiments of the stabilizing catheter prevent site loss of protein drugs, such as insulin. Other embodiments include a tubing that is layered with a material that substantially prevents diffusion of small, insulin formulation-stabilizing molecules out from the catheter, as well as substantially prevents the diffusion of small, insulin formulation-destabilizing molecules into the catheter, during a period of insulin infusion.

Abstract: An infusion leak detection system indicates that a fluid to be delivered into an individual's body has leaked near an infusion site. The infusion site is at a location where a delivery element, such as a cannula, needle, or the like, penetrates an individual's body. Preferably, one end of the delivery element is attached to a delivery device and the other end is inserted through an individual's skin terminating in an individual's subcutaneous tissue. The delivery element establishes fluid communication between the delivery device and the individual's subcutaneous tissue. In alternative embodiments, the delivery element may terminate in an other tissue such as, muscle, organ, inter-peritoneal, intra-peritoneal, or the like. The delivery device is attached to the surface of the individual's skin.

Abstract: Methods for reducing the electrode impedance of implantable biosensors by coating the surface of the biosensor with a uniform hydrogel which allows unimpeded water movement around the sensor are provided. The surface coatings are compositions which are biocompatible and are capable of water uptake of at least 120% of their weight, more preferably at least 200% of their weight. Upon the uptake of water, the hydrogels used in the present invention will also swell and provide a layer of water around the electrodes to which the hydrogels are attached. The hydrogels can be prepared from (a) a diisocyanate, (b) a hydrophilic polymer which is a hydrophilic diol, a hydrophilic diamine, or a combination thereof, and optionally, (c) a chain extender.

Abstract: A medication delivery device for delivering a small molecule insulin mimetic material to a body of an individual includes a housing, a reservoir and a controller. The housing contains a driving mechanism, and the reservoir is coupled to the driving mechanism in the housing for holding the small molecule insulin mimetic material to be infused into the body of the individual. The controller controls the driving mechanism to expel the small molecule insulin mimetic material from the reservoir into the body of the individual. Preferably, the medication delivery device is an infusion pump. In particular, the driving mechanism is a syringe type drive actuator, or a gas generator. The driving mechanism may also utilize iontophoresis or passive trans-dermal delivery. In addition, the driving mechanism is controlled to infuse the small molecule insulin mimetic material in a continuous, near-continuous, intermittent and pulsatile manner.