Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device involves obtaining one or more measurement values of a physiological condition in the body of a user during an initial monitoring period and determining a fasting reference value for a metric based on the one or more measurement values. After the initial monitoring period, the method continues by obtaining an updated measurement value during a fasting period, determining a current value for the metric based at least in part on the updated measurement value, and generating a notification in response to a deviation between the current value and the fasting reference value exceeding a threshold indicative of insertion site loss or other loss of effectiveness.

Abstract: A physiological characteristic sensor, a method for forming a physiological characteristic sensor, and a method for forming a platinum deposit having a rough surface are presented here. The method for forming a physiological characteristic sensor includes immersing a sensor electrode in a platinum electrolytic bath. Further, the method includes performing an electrodeposition process by sequentially applying a pulsed signal to the sensor electrode, wherein the pulsed signal includes a repeated cycle of a first current and a second current different from the first current, and applying a non-pulsed continuous signal to the sensor electrode, wherein the non-pulsed continuous signal includes a non-repeated application of a third current, to form a platinum deposit on the sensor electrode.

Abstract: A therapeutic agent injection device including an injection device for delivering a therapeutic agent to a patient having a body, the body having a patient face and a port face opposite the patient face, the port face having an introducer port including an introducer channel and an injection port including an injection channel, the introducer channel being in fluid communication with the injection channel through a cross channel, the injection channel defining an injection axis; a delivery tube for subcutaneous delivery of the therapeutic agent to the patient, the delivery tube projecting from and being generally perpendicular to the patient face, the delivery tube defining an introducer axis and being in fluid communication with the injection port; and a patch, the patch being attached to the patient face and being operable to adhesively attach to the patient; wherein the injection axis is parallel to the introducer axis.

Abstract: Ambulatory infusion pumps, pump assemblies, and disposable assemblies, including cartridges, baseplates, cannulas, inserters, and related components therefor, as well as component combinations and related methods.

Abstract: An infusion set for use with a fluid infusion device having a fluid reservoir includes a cannula that provides a fluid flow path and a first housing. The first housing includes an articulation member coupled to the cannula. The articulation member is pivotable relative to the first housing to move the cannula relative to the first housing. The first housing is coupled to a fluid supply line to provide a fluid to the cannula, and the fluid supply line is to be coupled to the fluid reservoir to receive the fluid. The infusion set includes a second housing uncoupled from the first housing that surrounds the first housing and receives a portion of the fluid supply line.

Abstract: A method for determining a volume of fluid dispensed into a test housing includes creating an electrical potential across at least one input electrode of a plurality of input electrodes and at least one output electrode of a plurality of output electrodes. The input electrodes and the output electrodes are each coupled to the test housing. The method includes receiving at least one signal from the at least one output electrode based on the fluid dispensed into the test housing. The method includes calculating the volume of fluid dispensed into the test housing based on the at least one signal received from the at least one output electrode, a dimension associated with an internal channel defined within the test housing, and a distance between two input electrodes of the plurality of input electrodes.

Abstract: A sensor set is provided for sensing of a body characteristic, such as glucose. The sensor set includes a mounting base for the sensor and a connector to connect to the mounting base and has an improved structure for connecting the mounting base to the connector. The connector may contain sensor electronics for wired or wireless communication to an external monitor or display. The mounting base includes latch arms and the connector adapted to fit and lock into latch recesses on the connector and includes anti-rotation arms adapted to fit into anti-rotation arm recesses on the connector.

Abstract: A sensor set is provided for sensing of a body characteristic, such as glucose. The sensor set includes a mounting base for the sensor including a shim adapted to prevent pull up of the sensor and a connector to connect to the mounting base and has an improved structure for connecting the mounting base to the connector. The connector may contain sensor electronics for wired or wireless communication to an external monitor or display. The mounting base includes latch arms and the connector adapted to fit and lock into latch recesses on the connector and includes anti-rotation arms adapted to fit into anti-rotation arm recesses on the connector.

Abstract: Embodiments relate to a cannula that is provided for delivering a substance, such as a medicine (e.g., insulin) to a patient, where the cannula has reduced likelihood of kinking or occlusions when implanted in a patient. The cannula may have a reduced number of stress concentrations along its length, an angled tip and/or a curve in its length. The cannula may include other designs to reduce kinking, such as internal ribbing and/or a slit along its wall.

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 physiological sensor history backfill system and method including a method of sensor history backfill for a local base device operable to wirelessly communicate with a physiological sensor connected to a patient, the method including: obtaining physiological readings for the patient at a predetermined interval; storing the physiological readings at the physiological sensor as sensor physiological readings; storing the physiological readings at the local base device as historic physiological readings; obtaining a current physiological reading for the patient; transmitting the current physiological reading to the local base device in a current reading message; detecting a record gap in the historic physiological readings between the current physiological reading and the historic physiological readings; and filling the record gap in the historic physiological readings with sensor physiological readings from the physiological sensor when the current reading message does not include the sensor physiological read

Abstract: The invention includes method and materials designed to measure the material properties (e.g. thickness) of layers of material in a sensor using non-Faradaic EIS (Electrochemical Impedance Spectroscopy) methods. The methods are non-destructive, very sensitive and rapid. Typically in these methods, an AC voltage is applied to the desired material layer while the output current and therefore impedance is measured. This voltage can be applied in multiple frequencies in sweep mode in order to detect both the material and, for example, the thickness of the target material. In this way, EIS allows the characterization of properties of various layers of material disposed in devices such as electrochemical glucose sensors.

Abstract: The invention is directed to a competitive glucose binding affinity assay comprising a glucose receptor (typically mannan binding lectin) labeled with an assay fluorophore and a modified glucose analog (typically dextran) labeled with a reference fluorophore. In certain embodiments, the glucose analog is dextran and is coupled to both a reference fluorophore and a quencher dye (e.g. hexamethoxy crystalviolet-1). Optionally the reference fluorophore is blue shifted relative to the assay fluorophore.

Abstract: A sensing device monitors and tracks food intake events and details. A processor, appropriately programmed, controls aspects of the sensing device to capture data, store data, analyze data and provide suitable feedback related to food intake. More generally, the methods might include detecting, identifying, analyzing, quantifying, tracking, processing and/or influencing, related to the intake of food, eating habits, eating patterns, and/or triggers for food intake events, eating habits, or eating patterns. Feedback might be targeted for influencing the intake of food, eating habits, or eating patterns, and/or triggers for those. The sensing device can also be used to track and provide feedback beyond food-related behaviors and more generally track behavior events, detect behavior event triggers and behavior event patterns and provide suitable feedback.

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: Ambulatory infusion pumps, medicament reservoirs, and medicament sealing assemblies, including a variety of trocar seal assemblies and fill plug seal assemblies, plus related components, as well as component combinations and related methods.

Abstract: Various embodiments of the present invention are directed to transferring fluidic media from a vial to a reservoir. In various embodiments, fluidic media may be transferred from the vial to the reservoir by moving a housing portion to move a plunger head located in the reservoir to draw fluidic media from the vial to the reservoir. In other embodiments, fluidic media may be transferred from the vial to the reservoir while the reservoir is held by a holding unit and vibrated by a vibrator to remove air from the fluidic media. In some embodiments, fluidic media may be transferred from the vial to the reservoir by moving a handle operatively connected to a bias member for assisting with the transfer of fluidic media. In other embodiments, the transfer of fluidic media may be assisted by a bias member and a needle connecting atmosphere and the vial.

Abstract: Embodiments of the invention provide analyte sensors having optimized electrodes and/or 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: An infusion system to administer fluid is disclosed. The infusion system includes an infusion pump having a pump processor, a pump memory and a pump radio to enable bi-directional communication. The pump memory stores a plurality of fingerprint tokens and security conditions. The infusion system includes a controller with a processor, a controller memory and a controller radio to transmit and receive communication from the pump radio. The controller includes a fingerprint scanner and a graphical user interface (GUI) and controls to manipulate the GUI. The GUI and fingerprint scanner enable the controller to scan and determine tokens based on scanned fingerprints. Additionally, communication between the infusion pump and the controller establish relative proximity between the infusion pump and the controller such that when the relative proximity exceeds a threshold distance at least one of the plurality of security conditions is automatically matched.