Abstract: A device to determine the level of a substance of interest in a patient's body and provide a therapeutic amount of medicament is disclosed. The level of a substance of interest in the patient's body is determined by iontopheretically sampling the patient's blood and then analyzing the resulting sample to determine the level of the substance of interest. The information about the level of a substance of interest is transmitted to an implanted drug pump in the patient's body. In the preferred embodiment, the substance of interest sensor is an external sensor applied to the user's skin. In an alternate embodiment, the sensor may be implanted. The preferred method of transmitting information about the level of a substance of interest determined by the sensor is transmitted to an implanted drug pump in the patient's body is via a so called “body bus”. The “body bus” is a telemetry system where the patient's own body provides the interconnection between the iontopheretic device and the implanted drug pump.

Abstract: A diabetes data management system selects variable threshold parameters to that are utilized in a report. A first low threshold glucose reading and a first high threshold glucose reading for a before meal event timeframe are selected. A second low threshold glucose reading and a second high threshold glucose reading are selected for an after meal event timeframe. The threshold readings are stored in a database. The diabetes data management system analyzes glucose behavior around meal events. The system receives a plurality of glucose readings for a time period, receives a first time range as a pre-meal analysis period for the first meal event and receives a second time range as a post-meal analysis period for the first meal event. The system creates a graph which highlights the pre-meal analysis period, the post-meal analysis period, and displays the plurality of glucose readings for the time period.

Abstract: A diabetes data management system selects variable threshold parameters to that are utilized in a report. A first low threshold glucose reading and a first high threshold glucose reading for a before meal event timeframe are selected. A second low threshold glucose reading and a second high threshold glucose reading are selected for an after meal event timeframe. The threshold readings are stored in a database. The diabetes data management system analyzes glucose behavior around meal events. The system receives a plurality of glucose readings for a time period, receives a first time range as a pre-meal analysis period for the first meal event and receives a second time range as a post-meal analysis period for the first meal event. The system creates a graph which highlights the pre-meal analysis period, the post-meal analysis period, and displays the plurality of glucose readings for the time period.

Abstract: A thin film sensor, such as a glucose sensor, is provided for transcutaneous placement at a selected site within the body of a patient. The sensor includes several sensor layers that include conductive layers and includes a proximal segment defining conductive contacts adapted for electrical connection to a suitable monitor, and a distal segment with sensor electrodes for transcutaneous placement. The sensor electrode layers are disposed generally above each other, for example with the reference electrode above the working electrode and the working electrode above the counter electrode. The electrode layers are separated by dielectric layer.

Abstract: The invention provides methods and apparatus for detecting an analyte in blood. The apparatus is particularly suited for bringing a sensor into direct contact with blood in vivo. The apparatus comprises a sensor that detects the presence of an analyte and an assembly means. The assembly means has a sensor end, wherein the sensor end of the assembly means is affixed to the sensor, and the assembly means is adapted for coupling with a venous flow device. By coupling with a venous flow device, the assembly means brings the sensor into direct contact with blood flowing through the venous flow device. Examples of venous flow devices that bring the sensor into direct contact with the blood of a subject include, but are not limited to, intravenous catheters and external blood loops, such as are used in extra corporeal membrane oxygenation or hemodialysis.

Abstract: A monitor device for a fluid infusion system and its operating, display, and data processing characteristics are described herein. One embodiment of the monitor device is used in an insulin infusion system having an insulin infusion pump and a continuous glucose sensor transmitter. The monitor device is configured as a wireless bedside monitor that wirelessly receives status data from a device in the fluid infusion system, such as the infusion pump or the sensor transmitter. The monitor device supports a number of user interface features, alarm/alert features, and graphical display features, where such features enhance the overall operation and user-friendliness of the monitor device. For example, the monitor device can generate status icons that graphically indicate the time remaining for an exhaustible operating quantity of a device in the infusion system (e.g., a battery charge, a fluid reservoir volume, or a calibration or replacement period).

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: An infusion medium delivery system, device and method for delivering an infusion medium to a patient-user, includes a needle inserter device and method for inserting a needle and/or cannula into a patient-user to convey the infusion medium to the patient-user. The needle inserter device and method operate to insert a needle and cannula into a patient-user's skin and automatically withdraw the needle from the patient-user, leaving the cannula in place and in fluid flow communication with a reservoir. The delivery device may include a base portion and a durable portion connectable to the base portion, and wherein the base portion can be separated from the durable portion and disposed of after one or more specified number of uses. The base portion supports the reservoir and the needle inserter device, while the durable portion supports a drive device for selectively driving the infusion medium out of the reservoir and into the needle and/or cannula.

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: Apparatuses and methods for medical monitoring physiological characteristic values such as blood glucose levels for the treatment of diabetes, are presented. The apparatuses and methods provide for preventing any negative consequence in the operation of a monitor and/or infusion device as a result of disorientation that may occur from waking from slumber with a low blood glucose level. In addition, a graphical display is disclosed incorporating a variety of enhancements which readily conveys to the user historical as well as real time information regarding the measured characteristic value.

Abstract: A method for formulating and immobilizing a protein and a protein matrix formed by the method. The protein matrix preparation method results in a physically and chemically stable protein matrix that has low swelling, non-leaching, high activity, and high mechanical strength properties. The method includes cross-linking and hardening the protein mixture and using a mold to form a protein into a desired shape and size.

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 packaging system for hydrating sterile devices without comprising the integrity of the sterilization. The packaging system may include an enclosure for enclosing a device requiring hydration, a container containing a hydrate, a base located within the interior of the enclosure and an activating member located within the interior of the enclosure. The container and the device may be located within a receptacle. The receptacle may rest on the base and the activating member may be affixed on top of the receptacle. A force may be exerted on an exterior portion of the enclosure such that the activating member pushes on the receptacle and crushes or ruptures the container. The hydrate located within the container is then released to the device, thereby hydrating the device without breaking the seal of the enclosure. The sterilized environment is therefore maintained and the device is hydrated.

Abstract: A closed loop infusion system controls the rate that fluid is infused into the body of a user. The closed loop infusion system includes a sensor system, a controller, and a delivery system. The sensor system includes a sensor for monitoring a condition of the user. The sensor produces a sensor signal, which is representative of the condition of the user. The sensor signal is used to generate a controller input. The controller uses the controller input to generate commands to operate the delivery system. The delivery system infuses a liquid into the user at a rate dictated by the commands from the controller. Preferably, the sensor system monitors the glucose concentration in the body of the user, and the liquid infused by the delivery system into the body of the user includes insulin.

Abstract: A closed loop infusion system controls the rate that fluid is infused into the body of a user. The closed loop infusion system includes a sensor system, a controller, and a delivery system. The sensor system includes a sensor for monitoring a condition of the user. The sensor produces a sensor signal, which is representative of the condition of the user. The sensor signal is used to generate a controller input. The controller uses the controller input to generate commands to operate the delivery system. The delivery system infuses a liquid into the user at a rate dictated by the commands from the controller. Preferably, the sensor system monitors the glucose concentration in the body of the user, and the liquid infused by the delivery system into the body of the user includes insulin.

Abstract: Apparatuses and methods for medical monitoring physiological characteristic values such as blood glucose levels for the treatment of diabetes, are presented. The apparatuses and methods provide for preventing any negative consequence in the operation of a monitor and/or infusion device as a result of disorientation that may occur from waking from slumber with a low blood glucose level. In addition, a graphical display is disclosed incorporating a variety of enhancements which readily conveys to the user historical as well as real time information regarding the measured characteristic value.

Abstract: A drive mechanism for delivery of infusion medium a coil capable of being electrically activated to provide an electromagnetic field. The coil surrounds a piston channel extending in an axial direction. The piston channel provides a passage for communication of infusion medium to an outlet chamber located at one end of the piston channel. An armature is located adjacent the coil, on one side of the axial channel. The armature is moveable toward a forward position, in response to the electromagnetic field produced by activation of the coil. A piston is located within the piston channel and is moveable axially within the channel to a forward position, in response to movement of the armature to its forward position. The armature and piston are moved toward a retracted position, when the coil is not energized. In the retracted position of the piston, a piston chamber is formed between the piston and a valve member and is filled with infusion medium.

Abstract: A closed loop system or semi-closed loop system for infusing insulin using sensor values applies a redundant sensor system as a fail-safe method against sensor failure. The redundant glucose sensors are used corroborate each other and a failing sensor is detected if the sensors no longer corroborate each other. The use of redundant sensors has the additional benefit of producing better sensor signals compared to the use of a single sensor.

Abstract: According to an embodiment of the invention, a method of determining hydration of a sensor having a plurality of electrodes is disclosed. In particular embodiments, the method couples a sensor electronics device to the sensor and measures the open circuit potential between at least two of the plurality of electrodes. Then, the open circuit potential measurement is compared to a predetermined value. In some embodiments, the plurality of electrodes includes a working electrode, a reference electrode, and a counter electrode. In still further embodiments, the open circuit potential between the working electrode and the reference electrode is measured. In other embodiments, the open circuit potential between the working electrode and the counter electrode is measured. In still other embodiments, the open circuit potential between the counter electrode and the reference electrode is measured.

Abstract: An improved reservoir is provided for use in a medication infusion device for operating the reservoir to administer a fluid to a patient. The reservoir comprises a hollow barrel adapted to receive a supply of fluid for delivery through infusion tubing or the like to the patient, in combination with a reservoir plunger. The reservoir plunger is designed to engage a motor-driven lead screw of the medication infusion device. The reservoir plunger has an integral split nut connector formed on the end of the plunger, which is in co-axial alignment with the lead screw whereby the split nut connector can be engaged directly to the lead screw.