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 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: 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 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: A fluid infusion device that delivers medication fluid to a user includes a removable fluid reservoir having a reservoir port and a hollow fluid reservoir needle, a base plate having a reservoir port receptacle for the reservoir port and the reservoir needle, and an inlet structure in the reservoir port receptacle to define at least a portion of a fluid chamber. The fluid infusion device also includes a needle sealing element having a base section, an end section opposite the base section, a neck section between the base section and the end section, and a needle opening extending through the base section, the neck section, and the end section. A compression element is coupled around the neck section to impart an inward biasing force near the needle opening.

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: A method of making a system for transferring fluidic media may include placing a reservoir body in an aseptic environment; filling an interior volume of the reservoir body with fluidic media; placing a plunger head into the reservoir body, the plunger head adapted to be movable in an axial direction within the reservoir body; removing the reservoir body from the aseptic environment; and attaching a casing adjacent to at least a portion of the reservoir body with the reservoir body outside the aseptic environment, the casing configured to envelope at least a portion of a plunger arm operatively connected to the plunger head, the casing further configured to allow the plunger arm to move in the axial direction relative to the reservoir body and at least partially within the reservoir body.

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 optical glucose sensor may include an optical fiber and a glucose-permeable membrane having a hollow interior and being coupled to the optical fiber's distal end. The membrane's hollow interior provides a compartment to house a competitive glucose binding affinity assay. The assay may include a glucose analog that may be labeled with a dye, and a glucose receptor that may be labeled with a fluorophore. The optical fiber may include a compound parabolic concentrator tip, and the compartment may additionally house a reflector disposed so as to face the optical fiber's tip. A fluorophore-labeled assay may be interrogated by an optical interrogating system including a light source and a filter substrate having one or more coatings to effect, e.g., an excitation filter and/or an emission filter. The interrogating system may be manufactured as a stacked planar integrated optical system and diced into smaller units.

Abstract: A continuous glucose monitoring system may include a hand-held monitor, a transmitter, an insulin pump, and an orthogonally redundant glucose sensor, which may comprise an optical glucose sensor and a non-optical glucose sensor. The former may be a fiber optical sensor, including a competitive glucose binding affinity assay with a glucose analog and a fluorophore-labeled glucose receptor, which is interrogated by an optical interrogating system, e.g., a stacked planar integrated optical system. The non-optical sensor may be an electrochemical sensor having a plurality of electrodes distributed along the length thereof. Proximal portions of the optical and electrochemical sensors may be housed inside the transmitter and operationally coupled with instrumentation for, e.g., receiving signals from the sensors, converting to respective glucose values, and communicating the glucose values.

Abstract: A portable medical device is provided with an internal accelerometer device. The medical device includes a circuit board, the accelerometer device, and a response module coupled to the accelerometer device. The accelerometer device is mechanically and electrically coupled to the circuit board, and it includes a plurality of mass-supporting arms for a plurality of electrically distinct sensor electrodes, piezoelectric material for the mass-supporting arm, and a proof mass supported by the mass-supporting arms. Each of the mass-supporting arms has one of the sensor electrodes located thereon. Acceleration of the proof mass causes deflection of the piezoelectric material, which generates respective sensor signals at one or more of the sensor electrodes. The response module is configured to initiate an acceleration-dependent operation of the portable medical device in response to generated sensor signals present at the sensor electrodes.

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: A sealing assembly is utilized for a fluid infusion device that cooperates with a fluid reservoir having a reservoir port and a hollow fluid reservoir needle at least partially located within the reservoir port. The sealing assembly has a reservoir port receptacle with a proximal end, a distal end extending from the proximal end, and a needle opening formed in the distal end to receive the hollow fluid reservoir needle. The sealing assembly also has a fluid chamber located at least partially in the reservoir port receptacle, and a needle sealing element having a self-sealing needle opening formed therein. The needle sealing element is located within the reservoir port receptacle between the distal end and the fluid chamber. The the self-sealing needle opening accommodates the hollow fluid reservoir needle when the reservoir port engages the reservoir port receptacle.

Abstract: A medical device system may include a set of housing portions, which includes a first housing portion and a second housing portion, and a third housing portion configured to be selectively operatively engaged with and disengaged from each of the first housing portion and the second housing portion. Each of one or more fluid conduits may provide a fluid path between a user and one or more reservoirs, for containing fluidic media, supported by at least one of the third housing portion and a selected one of the first housing portion and the second housing portion. A drive device supported by the third housing portion may be configured to transfer fluidic media between one of the one or more reservoirs and the user via the fluid conduit in a case where the third housing portion is operatively engaged with one of the first housing portion and the second housing portion.

Abstract: Embodiments of the invention provide to apparatuses and media used in drug elution studies and methods for making and using them. One embodiment of the invention is a drug elution method that can be used for in-vitro studies of a matrix impregnated with a compound such as a drug blended polymer matrix. Such methods and materials can be used for example to assess and control the manufacturing process variability of drug eluting implantable devices such as cardiac leads.

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: Various embodiments of the present invention are directed to equalizing pressure in a reservoir containing fluidic media, possibly due to imperfect installation of the reservoir or an external influence such as an altitude or a temperature change. In various embodiments, fluidic media may be expelled from the reservoir through a needle and contained in an interior volume of a pierceable member before the needle pierces the pierceable member to establish a flow path to a user. In other embodiments, fluidic media may be expelled through a port of the reservoir into a chamber. In further embodiments, fluidic media may be expelled through a channel in a plunger head and out a passage in the reservoir when the channel and passage are aligned. In other embodiments, fluidic media may be expelled through a valve, and the valve may be pierceable by a needle to establish a flow path to the user.

Abstract: A transfer guard may provide a fluid path from a vial to a reservoir containing a plunger head connected to a plunger arm operatively engagable with a handle that at least partially covers a casing configured to allow the handle to operatively engage the plunger arm to move the plunger head to transfer fluidic media from the vial to the reservoir. A support structure may have a chamber, a first adapter for mating with a vial containing fluidic media, and a second adapter for mating with a reservoir containing a plunger head moveable within the reservoir. A first needle may provide a fluid path from the vial to the reservoir and a second needle may connect the vial and the chamber containing an air flow control mechanism for allowing air to flow in one direction.