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: A fluidic media detection system for detecting a presence of fluidic media includes a first housing portion adapted to be carried by a user; a second housing portion configured to be selectively operatively engaged with and disengaged from the first housing portion, the second housing portion for supporting a reservoir having an interior volume for containing fluidic media; a fluid conduit supported by one of the first housing portion and the second housing portion for providing fluid communication between the reservoir and the user when the first housing portion and the second housing portion are operatively engaged; and at least one interactive element, positioned near a portion of the fluid conduit, that interacts with the fluidic media when the fluidic media is present in the fluid conduit.

Abstract: A method and apparatus for a connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump is provided. The reservoir, a base and a cap are connected to form an integrated unit that is capable of being inserted and secured in an infusion pump housing. The cap and the infusion pump are each provided with at least one sensor or at least one detectable feature, arranged to interact with at least one corresponding detectable feature or sensor on the other of the cap and infusion pump device, to detect one or more of the presence, position or other characteristic of the cap when the cap is aligned or coupled with the infusion pump housing. The detectable feature and sensor may be magnetic, RF, mechanical, optical or any combination.

Abstract: Medical devices are typically sterilized in processes used to manufacture such products and their sterilization by exposure to radiation is a common practice. Radiation has a number of advantages over other sterilization processes including a high penetrating ability, relatively low chemical reactivity, and instantaneous effects without the need to control temperature, pressure, vacuum, or humidity. Unfortunately, radiation sterilization can compromise the function of certain components of medical devices. For example, radiation sterilization can lead to loss of protein activity and/or lead to bleaching of various dye compounds. Embodiments of the invention provide methods and materials that can be used to protect medical devices from unwanted effects of radiation sterilization.

Abstract: Systems and methods for alignment and detection of a consumable component are disclosed herein. For example, a method for determining if a consumable component is coupled to a durable component to enable dispersion of a medicine is provided. The method includes determining if a signal from an electrical contact coupled to a durable component has changed an electrical state, and comparing the signal to a reference signal from a second electrical component coupled to the durable component. The method includes sampling a sensor coupled to the durable component to acquire sensor data indicative of a magnetic field observed by the sensor, and outputting data that a consumable component is coupled to the durable component if the signal is different than the reference signal, and the sensor data is within an acceptable range.

Abstract: A reservoir may be filled with fluidic media in a first type of environment, a plunger head may be placed within the reservoir in the first type of environment, and a casing that may be configured to envelop at least a portion of a plunger arm operatively connected to the plunger head may be attached adjacent to at least a portion of the reservoir in a second type of environment. A reservoir may be provided having a first and second portion for respectively containing fluidic media, the second portion may be adapted to be removable, the reservoir may be selectively filled with a first volume or a second volume of fluidic media, a seal member may be placed in the reservoir, and the second portion may be removed in a case where the reservoir contains the first volume of fluidic media.

Abstract: The disclosure provides a sensor including a sensor having an external surface and a cannula. The cannula comprises a substantially cylindrical wall encircling a lumen, at least one aperture and a distal end. The sensor is positioned within the lumen and the distal end of the cannula extends beyond the sensor. This configuration functions for example to stabilize chemical reactions associated with the sensor by creating a buffer zone between the sensor and the surrounding tissues at the site of implantation. In certain embodiments, the sensor can further comprise an accessory material in proximity to the external surface, wherein the accessory material modifies the biological response of a tissue that is in contact with the sensor. The sensor can also comprise anchors that keeps the sensor in contact with subcutaneous tissue of a subject upon insertion of the sensor into the body of the subject.

Abstract: The invention disclosed herein includes sensors having three dimensional configurations that allow expansive “360°” sensing (i.e. sensing analyte from multiple directions) in the environments in which such sensors are disposed. Embodiments of the invention provide analyte sensors having foldable substrates adapted to produce optimized configurations of electrode elements as well as methods for making and using such sensors. Typical embodiments of the invention include glucose sensors used in the management of diabetes.

Abstract: The disclosures made herein relate to an infusion device specifically adapted for syringe injections. In one embodiment of the disclosures made herein, an infusion device comprises a body including an accessible surface having a single inlet port therein, an engagement surface having a single outlet port therein, a medication delivery channel extending between the single inlet port and the single outlet port, and an identification feature on the accessible surface of the body adjacent to the single inlet port. The single inlet port of the medication delivery channel is tapered thereby forming a funnel-shaped entry into the medication delivery channel. A cannula is coupled to the body at the single outlet port and is adapted for receiving medication from the single outlet port and transmitting the medication therethrough.

Abstract: A system and method for providing closed loop infusion formulation delivery which accurately calculates a delivery amount based on a sensed biological state by adjusting an algorithm's programmable control parameters. The algorithm calculates a delivery amount having proportional, derivative, and basal rate components. The control parameters may be adjusted in real time to compensate for changes in a sensed biological state that may result from daily events. Safety limits on the delivery amount may be included in the algorithm. The algorithm may be executed by a computing element within a process controller for controlling closed loop infusion formulation delivery. The biological state is sensed by a sensing device which provides a signal to the controller. The controller calculates an infusion formulation delivery amount based on the signal and sends commands to an infusion formulation delivery device which delivers an amount of infusion formulation determined by the commands.

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 self-sealing needle opening accommodates the hollow fluid reservoir needle when the reservoir port engages the reservoir port receptacle.

Abstract: A method and apparatus for a connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump is provided. The reservoir, a base and a cap are connected to form an integrated unit that is capable of being inserted and secured in an infusion pump housing. The cap and the infusion pump are each provided with at least one sensor or at least one detectable feature, arranged to interact with at least one corresponding detectable feature or sensor on the other of the cap and infusion pump device, to detect one or more of the presence, position or other characteristic of the cap when the cap is aligned or coupled with the infusion pump housing. The detectable feature and sensor may be magnetic, RF, mechanical, optical or any combination.

Abstract: A method and apparatus for a connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump is provided. The reservoir, a base and a cap are connected to form an integrated unit that is capable of being inserted and secured in an infusion pump housing. The cap and the infusion pump are each provided with at least one sensor or at least one detectable feature, arranged to interact with at least one corresponding detectable feature or sensor on the other of the cap and infusion pump device, to detect one or more of the presence, position or other characteristic of the cap when the cap is aligned or coupled with the infusion pump housing. The detectable feature and sensor may be magnetic, RF, mechanical, optical or any combination.

Abstract: Disclosed are methods, apparatuses, etc. for determination and application of a unidimensional metric for assessing a patient's glycemic health. In one particular implementation, a computed metric may be used to balance short-term and long-term risks associated with a particular therapy. In another implementation, a computed unidimensional metric may be used to balance risks of hyperglycemia and hypoglycemia.

Abstract: An infusion system, which may be a closed loop infusion system or “semi-closed-loop” system, uses state variable feedback to control the rate that fluid is infused into the body of a user. The closed loop infusion system includes a sensor system, a controller, and a delivery system. The “semi-closed-loop” system further includes prompts that are displayed or sounded or otherwise provide indications to the user prior to fluid delivery. The sensor system includes a sensor for monitoring a condition of the user. The sensor produces a sensor signal, which is representative of the condition of the user. The delivery system infuses a fluid into the user at a rate dictated by the commands from the controller. The system may use three state variables, subcutaneous insulin concentration, plasma insulin concentration, and insulin effect, and corresponding gains, to calculate an additional amount of fluid to be infused as a bolus and to be removed from the basal delivery of the fluid.

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 measurements of one or more variables, the infusion pump detects whether there is an occlusion in the system. The methods of detecting occlusions may be dynamic.

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 measurements of one or more variables, the infusion pump detects whether there is an occlusion in the system. The methods of detecting occlusions may be dynamic.

Abstract: Apparatus are provided for infusion devices and related systems and operating methods. An exemplary system includes a motor, a sensing arrangement coupled to the motor to provide output indicative of a detected characteristic of the motor when the sensing arrangement is enabled, and a module coupled to the sensing arrangement to periodically enable the sensing arrangement while the motor is idle and detect potential unintended motion of the motor based on the output from the sensing arrangement while periodically enabling the sensing arrangement. In some embodiments, the motor includes a rotor configured such that its rotation provides translational displacement of a plunger in a fluid reservoir, and the sensing arrangement includes one or more sensors configured to provide output indicative of a detected magnetic field of the rotor magnet.

Abstract: Medical devices are typically sterilized in processes used to manufacture such products and their sterilization by exposure to radiation is a common practice. Radiation has a number of advantages over other sterilization processes including a high penetrating ability, relatively low chemical reactivity, and instantaneous effects without the need to control temperature, pressure, vacuum, or humidity. Unfortunately, radiation sterilization can compromise the function of certain components of medical devices. For example, radiation sterilization can lead to loss of protein activity and/or lead to bleaching of various dye compounds. Embodiments of the invention provide methods and materials that can be used to protect medical devices from unwanted effects of radiation sterilization.

Abstract: A delivery system for delivering fluidic media to a user having a second housing portion configured to be selectively operatively engaged with and disengaged from a first housing portion, the first housing portion and the second housing portion configured to be slidable relative to each other to operatively engage each other; and a fluid connector supported by one the housing portions in a position to engage a reservoir supported by an other of the housing portions in a case where the first housing portion and the second housing portion are slid relative to each other to operatively engage each other.