Abstract: An on-body injector and method of use including an on-body injector for use with an injection device. The on-body injector includes a bolus reservoir; a bolus injection needle in fluid communication with the bolus reservoir, the bolus injection needle having a bolus injection needle tip aligned with the injection port, the bolus injection needle being slideably biased away from the injection port to define a gap between the bolus injection needle tip and the injection port; and a button operably connected to the bolus injection needle to slide the bolus injection needle along the injection axis. The button is operable to advance the bolus injection needle tip to close the gap and advance the bolus injection needle tip into the injection port. The button is further operable to advance a plunger through the bolus reservoir to deliver a predetermined bolus volume to the patient through the injection flow path.

Abstract: An electronic injector including an electronic on-body injector for use with a patient to deliver a fluid through an injection device. The electronic on-body injector includes a fluid reservoir; a MEMS pump; a bolus injection needle, the bolus injection needle having a bolus injection needle tip aligned with the injection port, the bolus injection needle being slideably biased away from the injection port to define a gap; and a bolus needle button operably connected to the bolus injection needle to slide the bolus injection needle along the injection axis. The bolus needle button is operable to advance the bolus injection needle tip to close the gap and advance the bolus injection needle tip into the injection port to form a bolus injection flow path. The bolus needle button is further operable to activate the MEMS pump to deliver a predetermined bolus volume.

Abstract: A portable electronic device, such as a fluid infusion device, obtains its operating power from a primary battery and a secondary battery. The primary battery may be a replaceable battery, and the secondary battery may be a rechargeable battery that can be charged with the primary battery under certain conditions. The device utilizes a power management scheme that transitions between the primary battery and/or the secondary battery to prolong the useful life of the primary battery. The device may also generate an intelligent battery life indicator that displays an accurate representation of the remaining life of the primary battery.

Abstract: Disclosed are embodiments that relate to algorithms and methods for calibrating an analyte sensor, and more particularly, to algorithms for calibrating an optical glucose sensor comprising an equilibrium fluorescent chemical indicator system. In particular, a method of detecting an analyte concentration is disclosed where a modified Michaelis-Menten equation comprising Michaelis-Menten parameters is used to characterize the signal generated by the analyte sensor.

Abstract: Apparatus are provided for sensor assemblies and related medical devices. An embodiment of a sensor assembly includes a rigid structure and a beam structure having an outer portion in contact with the rigid structure and an inner portion. The beam structure includes one or more beams extending between the outer portion and the inner portion of the beam structure and a cantilevered portion extending from the inner portion to inhibit displacement of the inner portion toward the rigid structure. Each beam has a sensing element disposed thereon.

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 advanced alarm and reminder functions, as well as advanced data presentation tools to further facilitate convenient and efficient management of various physiological conditions. For example, an alarm repeat delay can be used to prevent redundant alarms for a specified period and an alarm snooze function can be used to prevent alarms generally for a specified period.

Abstract: Disclosed herein is a fluid infusion device of the type that delivers medication fluid to the body of a patient. The device includes or cooperates with a fluid reservoir, and the device has a sealing assembly to receive and form a fluid seal with the fluid reservoir. A retractable sealing element surrounding a hollow fluid delivery needle may be used to seal a port of the fluid reservoir. The port may include a pressure vent that is sealed by the retractable sealing element. In one variation, the reservoir includes a moving valve sleeve that holds a septum. The septum moves to allow the reservoir to vent, and to form a seal with the port when the needle pierces the septum. In another variation, the device includes a needleless sealing assembly. In yet other variations, the device uses a needled fluid reservoir.

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 apparatus for delivering a fluid includes a housing, an inlet in the housing for receiving the fluid, and an outlet in the housing for discharging the fluid. A piston channel is provided within the housing through which the fluid flows from the inlet to the outlet. An actuator is positioned within the housing and is moveable between a retracted position and a forward position, the actuator defining a piston chamber for storing fluid received through the inlet when the actuator is in the retracted position and for driving the fluid stored in the piston chamber toward the outlet when the actuator transitions from the retracted position to the forward position. The actuator includes an armature and a piston coupled to the armature and moveable within the piston channel. The piston channel wall is provided with a groove for conducting fluid from the inlet to the outlet.

Abstract: Analyte sensors having antioxidant protection are disclosed. By combining antioxidant and/or scavenger agents into polymer matrices that contain sensor moieties, the sensor moieties are protected from reactive oxygen species. Also disclosed are methods of making analyte sensors and methods of inhibiting oxidative degradation of sensing components in hydrated, polymerized analyte sensor systems.

Abstract: An implantable infusion pump possesses operational functionality that is, at least in part, controlled by software operating in two processor ICs which are configured to perform some different and some duplicate functions. The pump exchanges messages with an external device via telemetry. Each processor controls a different part of the drug infusion mechanism such that both processors must agree on the appropriateness of drug delivery for infusion to occur. Delivery accumulators are incremented and decremented with delivery requests and with deliveries made. When accumulated amounts reach or exceed, quantized deliverable amounts, infusion is made to occur. The accumulators are capable of being incremented by two or more independent types of delivery requests. Operational modes of the infusion device are changed automatically in view of various system errors that are trapped, various system alarm conditions that are detected, and when excess periods of time lapse between pump and external device interactions.

Abstract: An infusion system to administer a fluid includes an infusion pump with a pump processor, a pump memory to store a plurality of configurable alarms and a pump radio to enable bi-directional communication. The infusion system further includes a controller that has a controller processor, a controller memory, a controller radio to transmit and receive communication from the pump radio. The controller further has a graphical user interface shown on a display along with controls to manipulate the graphical user interface. Furthermore, the bi-directional communication between the infusion pump and the controller establish an infusion pump relative proximity between the infusion pump and the controller such that when the infusion pump relative proximity exceeds a pump threshold distance at least one of the plurality of configurable alarm conditions of the infusion pump is modified.

Abstract: An insertion device may include a device housing configured to be operatively engaged with and disengaged from a base, and engageable with an actuation device, the device housing having a carrier body supporting a piercing member. The carrier body moveable by a carrier body of the actuation device at least between a retracted position and an advanced position. The device housing having a section for supporting a portion of the carrier body of the device housing, the section moveable relative to the carrier body of the device housing to provide sufficient clearance to allow the carrier body of the device housing to be moved by the carrier body of the actuation device.

Abstract: A method and apparatus for a connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump is provided. A base is provided which is adapted to receive a reservoir. The base has a base engagement member, such as a detent, projecting therefrom. A cap is provided which is adapted to receive the base. The cap includes a first cap engagement member, such as a detent opening, which is adapted to removably engage the base detent. The cap further includes a second cap detent opening which is adapted to removably engage the base detent. A piercing member, such as a needle, is disposed in the interior of the cap in such a manner that the needle is separated from the reservoir septum when the base detent is in the first cap detent opening, and the needle pierces the reservoir septum when the base detent is in the second cap detent opening.

Abstract: Disclosed are a system and method for determining a metric and/or indicator of a reliability of a blood glucose sensor in providing glucose measurements. In one aspect, the metric and/or indicator may be computed based, at least in part, on an observed trend associated with signals generated by the blood glucose sensor.

Abstract: A medical device system includes at least one controllable patient-worn or patient-carried medical device, and a plurality of controller devices that are capable of independently controlling features or functions of the patient medical device. Control commands and other data is wirelessly communicated among the patient medical device and the multiple controller devices. A number of techniques, protocols, and other measures are provided to coordinate wireless communication between the various devices in a medical device system. These control command coordination processes address situations where conflicting, redundant, or concurrent control commands might be independently issued by the multiple controller devices.

Abstract: An infusion set for use with a fluid infusion device is provided. The infusion set can include a mount including a projection having a bore. The projection can be surrounded at least partially by a recess defined through a surface of the mount, and the mount can include at least one rib that spans the recess. The infusion set can include a fluid outlet coupled to at least a portion of the bore of the projection and a coupling device to couple the infusion set to a user. The coupling device can be coupled to the surface and the at least one rib of the mount.

Abstract: A first device housing may be configured to be operatively engaged with and disengaged from a base carried by a user and may include a first carrier body arranged for movement at least between a refracted position and an advanced position. The first carrier body may support a piercing member for insertion through skin of the patient. A second device housing may be configured to be operatively engaged with and disengaged from the first device housing and may include a second carrier body operatively connectable with the first carrier body and arranged for movement at least between a retracted position and an advanced position. A driver in the second device housing may be arranged to move the first carrier body toward the advanced position to insert at least a portion of the piercing member through skin of the patient.

Abstract: Disclosed herein is a fluid infusion device of the type that delivers medication fluid to the body of a patient. The device includes or cooperates with a fluid reservoir, and the device has a sealing assembly to receive and form a fluid seal with the fluid reservoir. A retractable sealing element surrounding a hollow fluid delivery needle may be used to seal a port of the fluid reservoir. The port may include a pressure vent that is sealed by the retractable sealing element. In one variation, the reservoir includes a moving valve sleeve that holds a septum. The septum moves to allow the reservoir to vent, and to form a seal with the port when the needle pierces the septum. In another variation, the device includes a needleless sealing assembly. In yet other variations, the device uses a needled fluid reservoir.

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.