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: Apparatus are provided for sensor assemblies and related medical devices. An embodiment of a sensor assembly includes a beam and a sensing element disposed on the beam. The sensor assembly also includes a structure to prevent deflection of the beam when a force applied to the sensor assembly is greater than a threshold value.

Abstract: A device for delivering fluid to a user includes a housing, a drive motor assembly in the housing, a force sensor, and an electronics module. The drive motor assembly regulates delivery of fluid by actuating a piston of a fluid reservoir, and the force sensor generates output levels in response to force imparted thereto during, for example, fluid delivery operations. The electronics module processes the output levels of the force sensor to assess the operating health of the force sensor, to check for occlusions in the fluid delivery path, and to monitor the seating status of the fluid reservoir.

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: The present invention provides a reservoir compartment adapter for use with a fluid delivery device. The adapter includes a first end adapted for coupling with a fluid delivery device, a second end adapted for coupling with a connector, and a structure between the first end and the second end including an interior space for receiving the reservoir, wherein an extended reservoir compartment for accommodating the reservoir is adapted to be formed when the first end is coupled to the fluid delivery device, and the reservoir is adapted to be secured in the extended reservoir compartment when the connector is coupled to the second end. The adapter allows a user of a delivery device accommodating reservoirs of a certain size to manage periods where increased medication dosage is needed without the burden of carrying a larger delivery device for accommodating reservoirs filled with the increased dosage.

Abstract: Embodiments of the invention provide compositions which are effective to inhibit the development of biofilms on a surface of a medical device having the composition applied thereto, to medical devices having the composition applied to a surface thereof and to methods for using the compositions to coat medical devices.

Abstract: A closed loop/semi-closed loop infusion system provides therapy modification and safeguards against the over-delivery or under-delivery of insulin. A glucose sensor system is configured to obtain a measured blood glucose value. A controller is operationally connected with the glucose sensor system and configured to trigger an alarm based on a measured blood glucose value or amount of insulin delivered, selectively perform calibration of the glucose sensor system when the alarm is triggered, and adjust a therapy delivery parameter when the alarm is triggered, wherein the adjusted therapy delivery parameter is limited to be within a boundary. Thereafter, a delivery system delivers therapy at the adjusted therapy delivery parameter.

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 medical device includes a first housing portion (FHP) and a second housing portion (SHP) configured to be to be movable relative to each other from a first position to operatively engage at a second position to couple at least one of a drive device and a needle-inserting device supported by one of the FHP and the SHP to a reservoir supported by the other of the FHP and the SHP. Electronic circuitry configured to detect at least one of a first magnetic interaction between a magnet and at least one of a first magnetically attractive material and a first magnet-responsive device and a second magnetic interaction between the magnet and at least one of a second magnetically attractive material and a second magnet-responsive device, and to provide a signal or a change in state in response to detecting at least one of the interactions.

Abstract: Systems and methods allow for limiting a presence of air bubbles in a fluidic medium filled into a reservoir. A fluidic medium may be forced from a vial into a reservoir. A vial may be degassed prior to being used to fill a reservoir. A filling process may be automated and a membrane may be located in a fluid flow path to trap air bubbles in a fluidic medium being filled into a reservoir.

Abstract: Disclosed are methods, apparatuses, etc. for providing a visual expression of the performance of one or more blood glucose sensors. In one particular example, a relative comparison of a rate of change sensor blood glucose and a rate of change in reference blood glucose may be expressed in a polar plot or graph. The polar plot or graph may then be generated onto a visual medium.

Abstract: Subject matter disclosed herein relates to monitoring and/or controlling levels of an analyte in bodily fluid. In particular, estimation of a concentration of the analyte in a first physiological compartment based upon observations of a concentration of the analyte in a second physiological compartment may account for a latency in transporting the analyte between the first and second physiological compartments.

Abstract: A system for identifying a reservoir used with a fluid delivery device. The system includes a reservoir comprising a housing for holding fluid and a colored marking located on a surface of the housing. A fluid delivery device includes a compartment for receiving and operatively coupling with the reservoir. A light source shines light on the colored marking of the reservoir. A color sensor detects wavelengths reflected and/or refracted from the colored marking due to the light shined on the colored marking. A processor of the delivery device determines a color of the colored marking from the detected wavelengths and ascertains information related to the reservoir or the fluid in the reservoir corresponding to the determined color, wherein the processor operates the fluid delivery device according to the ascertained information, wherein the information may include a reservoir type and/or medication type.

Abstract: The disclosure provides methods for fabricating a long-term analyte sensor for measuring at least one analyte in the body of a user. The analyte sensors made by these methods include a plurality of analyte contacting sensor elements and at least one structure for relaying information to and from the sensor. The analyte sensor so fabricated further includes at least one sensor protection membrane that is controllable in a manner such that sensor elements may be activated (e.g. exposed to the external environment) at different times so as to extend the useful life of the sensor. In illustrative analyte sensors, the analyte is glucose.

Abstract: A modular external infusion device that controls the rate a fluid is infused into an individual's body, which includes a first module and a second module. More particularly, the first module may be a pumping module that delivers a fluid, such as a medication, to a patient while the second module may be a programming module that allows a user to select pump flow commands. The second module is removably attachable to the first module.

Abstract: An insertion device, generally used with an infusion set, including a needle being adapted for puncturing at one end and including at the opposite end a hub. The hub includes a handle part and a guard part that are capable of securing the needle through the use of locks. Locking structures are used to secure the insertion device in a position where the needle is covered in a locked position, avoiding unintended contact with the needle.

Abstract: An injection apparatus for making an injection at a predetermined depth in skin comprises: a first skin positioning member, a second skin positioning member, wherein the first and second skin positioning members lie or are moveable to lie in an injection arrangement; an injection needle; and an injection needle movement guide to guide the injection needle for movement from a parking position above the skin, through the lower surface of the second skin positioning member to slide beneath the first skin positioning member to an injection position. A further injection apparatus comprises: an injection needle; a plunger within the injection needle; and a retractor to retract the injection needle such that material to be injected is expelled from the injection needle by the plunger.

Abstract: Systems and methods for non-vascular sensor implantation and for measuring physiological parameters in areas of a body where the physiological parameters are heterogeneous. An implant unit is implanted in an area of a body and a foreign body capsule is allowed to form around the implant unit area. A sensor may be directed into a body cavity such as, for example, the peritoneal space, subcutaneous tissues, the foreign body capsule, or other area. A subcutaneous area of the body may be tunneled for sensor placement. Spatially separated sensing elements may be used for detecting individual amounts of the physiological parameter. An overall amount of the physiological parameter may be determined by calculating a statistical measurement of the individual sensed amounts in the area. Another embodiment of the invention, a multi-analyte measuring device, may include a substrate having an electrode array on one side and an integrated circuit on another side.

Abstract: Embodiments of the invention provide methods of crosslinking various compounds and materials made by these methods. Materials made by embodiments of the invention include glucose sensors used in the management of diabetes.

Abstract: An insertion device, generally used with an infusion set, including a needle being adapted for puncturing at one end and including at the opposite end a hub. The hub includes a handle part and a guard part that are capable of securing the needle through the use of locks. Locking structures are used to secure the insertion device in a position where the needle is covered in a locked position, avoiding unintended contact with the needle.