Abstract: Embodiments of the invention provide a dual insertion set for supplying a fluid to the 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 piercing member for supplying a 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 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 the skin of a patient.

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 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 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 external infusion device comprising a housing, a motor contained within the housing, programmable electronics, a fluid reservoir, and a reservoir sleeve, where the fluid reservoir is encapsulated by the reservoir sleeve. The reservoir sleeve may be made of rubber, neoprene, or the like, and may be supported by a metal mesh-like frame support structure that is infused within the material. Additionally, the fluid reservoir may be made of plastic or glass, and contain insulin or other fluids for administering to humans.

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 media are supported by the disposable housing portion for disposal after the prescribed use, while the durable housing portion supports other components such as electronics for controlling delivery of infusion media from the reservoir and a drive device and drive linkage.

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 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 reusable analyte sensor site for use with a replaceable analyte sensor for determining a level of an analyte includes a site housing material and a resealable insertion site coupled to one end of the site housing material. Preferably, the site housing material is formed to have an interior cavity with an opening. The site housing material is selected to promote tissue ingrowth and vascularization, and yet be free of tissue ingress. Also, the site housing material permits the analyte to pass through the site housing material to the interior cavity to permit measurement by the replaceable analyte sensor. The resealable insertion site provides a for inserting the replaceable analyte sensor into the interior cavity of the site housing material.

Abstract: A reusable analyte sensor site for use with a replaceable analyte sensor for determining a level of an analyte includes a site housing and a resealable insertion site coupled to one end of the site housing. Preferably, the site housing is formed to have an interior cavity, and includes an outer membrane made of a material selected to promote vascularization and having a first pore size, and an inner membrane made of a material selected to be free of tissue ingress. Also, the site housing permits the analyte to pass through the site housing to the interior cavity to permit measurement by the replaceable analyte sensor. The resealable insertion site is provided for inserting the replaceable analyte sensor into the interior cavity of the site housing.

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: An improved pump, reservoir and reservoir piston are provided for controlled delivery of fluids. A motor is operably coupled to a drive member, such as a drive screw, which is adapted to advance a plunger slide in response to operation of the motor. The plunger slide is removably coupled to the piston. The piston comprises a first member and a second member. The first member has an external proximate side and an external distal side. The external proximate side is adapted to contact the fluid and is made of a material having a first stiffness. The second member has a first side and a second side and is at least partially disposed within the first member. The first side of the second member is adjacent to the external proximate side of the first member and is made of a material having a stiffness which is greater than the first stiffness.

Abstract: A reusable analyte sensor site for use with a replaceable analyte sensor for determining a level of an analyte includes a site housing and a resealable insertion site coupled to one end of the site housing. Preferably, the site housing is formed to have an interior cavity, and includes an outer membrane made of a material selected to promote vascularization and having a first pore size, and an inner membrane made of a material selected to be free of tissue ingress. Also, the site housing permits the analyte to pass through the site housing to the interior cavity to permit measurement by the replaceable analyte sensor. The resealable insertion site is provided for inserting the replaceable analyte sensor into the interior cavity of the site housing.

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: A reusable analyte sensor site for use with a replaceable analyte sensor for determining a level of an analyte includes a site housing material and a resealable insertion site coupled to one end of the site housing material. Preferably, the site housing material is formed to have an interior cavity with an opening. The site housing material is selected to promote tissue ingrowth and vascularization, and yet be free of tissue ingress. Also, the site housing material permits the analyte to pass through the site housing material to the interior cavity to permit measurement by the replaceable analyte sensor. The resealable insertion site provides a for inserting the replaceable analyte sensor into the interior cavity of the site housing material.

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: An improved pump, reservoir and reservoir piston are provided for controlled delivery of fluids. A motor is operably coupled to a drive member, such as a drive screw, which is adapted to advance a plunger slide in response to operation of the motor. The plunger slide is removably coupled to the piston. The piston comprises a first member and a second member. The first member has an external proximate side and an external distal side. The external proximate side is adapted to contact the fluid and is made of a material having a first stiffness. The second member has a first side and a second side and is at least partially disposed within the first member. The first side of the second member is adjacent to the external proximate side of the first member and is made of a material having a stiffness which is greater than the first stiffness.

Abstract: An implantable infusion device includes a housing having opposite first and second walls and a relatively large blind passage extending into the housing from the first wall toward the second wall. A first self-sealing septum blocks the passage at the first wall and a second self-sealing septum blocks the passage at a location therein spaced from the first septum thereby defining an infusate chamber between the first and second septa and a blind chamber between the second septum and the housing second wall. A fluid pathway containing a normally closed valve extends from the infusate chamber to the exterior of the housing and a lever connected to the valve is located in the blind chamber. That lever may be depressed to open the valve only by a needle inserted through the two septa into the blind chamber which needle has a side opening aligned with the infusate chamber when such depression occurs.

Abstract: A dual access infusion or monitoring system comprises implantable apparatus and an injection needle. This system enables one to introduce into or withdraw from the apparatus, after it is implanted, a plurality of fluids simultaneously with only a single penetration of the patient's skin. The implantable apparatus includes a sealed housing with an inlet passage extending into the housing which passage has an outer end adjacent to the housing surface and an inner end located inside the housing. A needle stop is positioned at the inner end of that passage and self-sealing septa are mounted at different locations along the passage at selected spacings from the needle stop so as to divide the passage into aligned compartments or segments each of which has its own fluid outlet. The injection needle includes a plurality of lumens, the number of same corresponding to the number of different compartments in the apparatus housing.