Abstract: Embodiments of the invention provide a dual insertion set for supplying a fluid to a body of a patient and for monitoring a body characteristic of the patient. Typical embodiments of the invention include a base, an infusion portion coupled to a first piercing member and a sensor portion coupled to a second piercing member. The infusion portion includes a cannula coupled to the first piercing member for supplying the fluid to a placement site. The sensor portion includes a sensor coupled to and extending from the base having at least one sensor electrode formed on a substrate and is coupled to the second piercing member in a manner that allows the sensor to be inserted at the placement site. The base is arranged to secure the dual insertion set to skin of the patient.

Abstract: An apparatus for sensing multiple parameters includes an implantable housing and a plurality of implantable sensors disposed within the implantable housing. The plurality of implantable sensors sense parameters in a patient, such as biological or physiological parameters, for example, and each responds to an analyte in the patient. The plurality of implantable sensors may include, but is not limited to, electrochemical, potentiometric, current and optical sensors.

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: A delivery device includes first and second housing portions that selectively engage and disengage. A reservoir on one housing portion operatively engages a drive device and/or a needle inserting device on the other housing portion. Upon proper engagement of the housing portions, the reservoir operatively couples to the drive device and/or the needle inserting device. A first magnet on the first housing portion and a second magnet (or a magnetically-attractive material) on the second housing portion are positioned to magnetically interact with each other, upon operative engagement of the housing portions. A third magnet on the second housing portion may be opposed to the first magnet to help align the housing portions for connection. A magnet-responsive device may be on one or both housing portions to detect alignment and/or connection of the housing portions.

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 delivery device includes a durable housing portion and a separable disposable portion that selectively engage and disengage from each other. The disposable housing portion secures to the patient-user and may be disposed of after it has been in use for a prescribed period. Components that normally come into contact with a patient-user or with infusion medium are supported by the disposable housing portion, while the durable housing portion supports other components such as electronics and a drive device. A reservoir is supported by the disposable housing portion and has a moveable plunger that operatively couples to the drive device, when the disposable and durable housing portions are engaged.

Abstract: An automobile monitoring system to monitor user body characteristics, includes at least one sensor to monitor at least one user body characteristic. The at least one sensor is operatively coupled to a body of a user to monitor the at least one user body characteristic while the user is operating an automobile. The at least one user body characteristic is at least a glucose level of the user's body. At least one transmitter is operatively coupled to the at least one sensor to communicate sensor data obtained from the at least one sensor while the user is operating the automobile. Automobile electronics are operatively coupled to the at least one transmitter to receive sensor data from the at least one sensor while the user is operating the automobile. The automobile electronics provide the sensor data to the user while the user is operating the automobile.

Abstract: An automobile monitoring system to monitor user body characteristics includes at least one sensor to monitor at least one user body characteristic. The at least one sensor is operatively coupled to a body of a user to monitor the at least one user body characteristic while the user is operating an automobile. The at least one user body characteristic is at least a glucose level of the user's body. At least one transmitter is operatively coupled to the at least one sensor to communicate sensor data obtained from the at least one sensor while the user is operating the automobile. Automobile electronics are operatively coupled to the at least one transmitter to receive sensor data from the at least one sensor while the user is operating the automobile. The automobile electronics provide the sensor data to the user while the user is operating the automobile. A global positioning system (GPS) is operatively coupled to the automobile electronics to determine a current location of the user.

Abstract: A multilumen catheter having tubings extending into lumens within the catheter. The lumens may be used for blood, drugs or other medicants. The lumens may also be used for sensors. The junction element, external to the patient, connects the tubings to the lumens. The tubings, also external to the patient, connect to infusion members, to which one or more infusion systems may be connected to deliver blood, drugs and other medicants to the patient. A sensor having a sensing element may extend through the sensor lumen and be positioned internal to the patient for physiological parameter sensing. An external portion of the sensor may be connected to associated electronics to provide automatic monitoring of the physiological parameters and automatic delivery and control of the infusants.

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: A multilumen catheter having tubings extending into lumens within the catheter. The lumens may be used for blood, drugs or other medicants. The lumens may also be used for sensors. The junction element, external to the patient, connects the tubings to the lumens. The tubings, also external to the patient, connect to infusion members, to which one or more infusion systems may be connected to deliver blood, drugs and other medicants to the patient. A sensor having a sensing element may extend through the sensor lumen and be positioned internal to the patient for physiological parameter sensing. An external portion of the sensor may be connected to associated electronics to provide automatic monitoring of the physiological parameters and automatic delivery and control of the infusants.

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: A delivery device includes first and second housing portions that selectively engage and disengage. A reservoir on one housing portion operatively engages a drive device and/or a needle inserting device on the other housing portion. Upon proper engagement of the housing portions, the reservoir operatively couples to the drive device and/or the needle inserting device. A first magnet on the first housing portion and a second magnet (or a magnetically-attractive material) on the second housing portion are positioned to magnetically interact with each other, upon operative engagement of the housing portions. A third magnet on the second housing portion may be opposed to the first magnet to help align the housing portions for connection. A magnet-responsive device may be on one or both housing portions to detect alignment and/or connection of the housing portions.

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: An automobile monitoring system to monitor user body characteristics, includes at least one sensor to monitor at least one user body characteristic. The at least one sensor is operatively coupled to a body of a user to monitor the at least one user body characteristic while the user is operating an automobile. The at least one user body characteristic is at least a glucose level of the user's body. At least one transmitter is operatively coupled to the at least one sensor to communicate sensor data obtained from the at least one sensor while the user is operating the automobile. Automobile electronics are operatively coupled to the at least one transmitter to receive sensor data from the at least one sensor while the user is operating the automobile. The automobile electronics provide the sensor data to the user while the user is operating the automobile.

Abstract: An automobile monitoring system to monitor user body characteristics includes at least one sensor to monitor at least one user body characteristic. The at least one sensor is operatively coupled to a body of a user to monitor the at least one user body characteristic while the user is operating an automobile. The at least one user body characteristic is at least a glucose level of the user's body. At least one transmitter is operatively coupled to the at least one sensor to communicate sensor data obtained from the at least one sensor while the user is operating the automobile. Automobile electronics are operatively coupled to the at least one transmitter to receive sensor data from the at least one sensor while the user is operating the automobile. The automobile electronics provide the sensor data to the user while the user is operating the automobile. A global positioning system (GPS) is operatively coupled to the automobile electronics to determine a current location of the user.

Abstract: An automobile monitoring system to monitor user body characteristics includes at least one sensor to monitor at least one user body characteristic. The at least one sensor is operatively coupled to a body of a user to monitor the at least one user body characteristic while the user is operating an automobile. The at least one user body characteristic is at least a glucose level of the user's body. At least one transmitter is operatively coupled to the at least one sensor to communicate sensor data obtained from the at least one sensor while the user is operating the automobile. Automobile electronics are operatively coupled to the at least one transmitter to receive sensor data from the at least one sensor while the user is operating the automobile. The automobile electronics provide the sensor data to the user while the user is operating the automobile. A global positioning system (GPS) is operatively coupled to the automobile electronics to determine a current location of the user.

Abstract: According to one embodiment, a programmable medical device includes a storage means for storing a plurality of software modules operable to control one or more medical functions of the device. The device is configured to receive a plurality of commands. An operational state of each of the software modules is configured to be controlled according to a respective one of the commands.

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 multilumen catheter having tubings extending into lumens within the catheter. The lumens may be used for blood, drugs or other medicants. The lumens may also be used for sensors. The junction element, external to the patient, connects the tubings to the lumens. The tubings, also external to the patient, connect to infusion members, to which one or more infusion systems may be connected to deliver blood, drugs and other medicants to the patient. A sensor having a sensing element may extend through the sensor lumen and be positioned internal to the patient for physiological parameter sensing. An external portion of the sensor may be connected to associated electronics to provide automatic monitoring of the physiological parameters and automatic delivery and control of the infusants.