Abstract: A fluid pathway assembly includes a needle insertion mechanism, a fluid conduit, and a fluid pathway connection. The fluid pathway assembly may further include a drug container to hold a drug fluid prior to initiation of the injection. The assembly may include a carrier disposed along at least a portion of the fluid pathway assembly, and/or a drug container. The fill-finish cartridge functions to retain the components of the fluid pathway assembly in a sterile condition, while allowing for easy integration of the fluid pathway assembly and the drug container into a standard fill-finish process. Methods of constructing a cartridge, filling a drug container included in a cartridge, and incorporating the same into a drug delivery device are disclosed.

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 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 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 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. A method, system, and an article of manufacture for automatically detecting an occlusion in a medication infusion pump is provided. The electrical current to an infusion pump is measured. Based on a series of measurements of one or more variables, the infusion pump detects whether there is an occlusion in the system.

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: 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 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 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: A user-initiated fluid pathway connection includes: a connection hub, a piercing member, a sterile sleeve, and a drug container having a cap, a pierceable seal, a barrel, and a plunger seal, wherein the piercing member is initially retained within the sterile sleeve between the connection hub and the pierceable seal of the drug container. The connection hub may include an internal aperture within the connection hub which functions as a flow restrictor and wherein a piercing member is connected to one end of the internal aperture and a fluid conduit is connected to another end of the internal aperture. A drug delivery pump with integrated sterility maintenance features includes a housing, upon which an activation mechanism, an insertion mechanism, a fluid pathway connection as described above, a power and control system, and a drive mechanism connected to a drug container are mounted. Methods of assembly and operation are also provided.

Abstract: An insertion mechanism for a drug pump includes an insertion mechanism housing; a manifold guide; an insertion biasing members initially held in an energized state; a retraction biasing member and a hub connected to a proximal end of a needle, wherein the retraction biasing member is held initially in an energized state between the hub and the manifold guide; and a manifold having a septum and a cannula, wherein the annular space between the septum and the cannula defines a manifold header. The needle and cannula are inserted into the body of a user by the insertion biasing member(s), after which only the needle is retracted. Retraction of the needle may open a fluid pathway from the manifold header to the body through the cannula. A drug delivery pump includes an activation mechanism, a drive mechanism, a fluid pathway connection, and the insertion mechanism. Assembly and operation methods are provided.

Abstract: A drive mechanism having integrated status indication includes a drive housing, a status switch interconnect, a drive biasing member, a piston, and a drug container having a cap, a pierceable seal, a barrel, and a plunger seal, wherein the drive biasing member is configured to bear upon an interface surface of the piston. Drive mechanism may include an incremental status stem having a stem interconnect, wherein the stem resides within the drive housing and the piston, and wherein the stem has an interconnect which engages one or more contacts on the piston to provide incremental feedback. A drug delivery pump with integrated status indication includes a housing and an assembly platform, upon which an activation mechanism, an insertion mechanism, a fluid pathway connection, a power and control system, and the drive mechanism having a drug container may be mounted.

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: 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: A fluid infusion system as described herein includes a number of local “body network” devices, such as an infusion pump, a handheld monitor or controller, a physiological sensor, and a bedside or hospital monitor. The body network devices can be configured to support communication of status data, physiological information, alerts, control signals, and other information between one another. In addition, the body network devices can be configured to support networked communication of status data, physiological information, alerts, control signals, and other information between the body network devices and “external” devices, systems, or communication networks. Such external communication allows the infusion system to be extended beyond the traditional short-range user environment.

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 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. A method, system, and an article of manufacture for automatically detecting an occlusion in a medication infusion pump is provided. The electrical current to an infusion pump is measured. Based on a series of measurements of one or more variables, the infusion pump detects whether there is an occlusion in the system.

Abstract: A delivery system for delivering fluidic media may include a second housing configured to be selectively operatively engaged with and disengaged from a first housing portion adapted to be carried by a user. One of the housing portions may support a reservoir for containing fluidic media and a plunger head moveable within the reservoir. A drive device may be supported by the other of the housing portions for coupling with the reservoir upon the housing portions being operatively engaged. A first interactive element may be supported on the first housing portion for interacting with a second interactive element supported on the second housing portion. Circuitry may be configured to detect an interaction between the interactive elements and configured to provide a signal or a change in state in response to the housing portions being operatively engaged and an interaction between the interactive elements being detected.

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.