Abstract: Subject matter disclosed herein relates to monitoring and/or controlling blood glucose levels in patients. In particular, one or more substances may be delivered to a patient at a particular infusion rate while the patient's estimated glucose level is within a predetermined range. A different insulin infusion rate may then be applied if the patient's estimated blood glucose level deviates outside of the predetermined range.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device capable of delivering fluid to a user involves a control system associated with the infusion device obtaining a first measurement indicative of a physiological condition of the user from a first sensing arrangement, obtaining one or more measurements from a second sensing arrangement indicative of a second condition of the user. The control system classifies the second condition as corresponding to one of a plurality of intensity levels based at least in part on the one or more measurements, and thereafter operates the infusion device to deliver the fluid to the user based on the first measurement of the physiological condition in a manner that is influenced by the intensity level classification.

Abstract: Infusion systems including infusion devices and consumables and related operating methods are provided. An exemplary consumable component includes a housing, a reservoir contained within the housing, a pumping mechanism for dispensing a fluid from the reservoir, and a readable element associated with the housing. The readable element maintains calibration data characterizing a relationship between delivery of the fluid and actuation of the pumping mechanism.

Abstract: Medical devices and related patient management systems and parameter modeling methods are provided. An exemplary method involves obtaining, by a computing device, historical measurements of a condition in a body of the patient previously provided by a sensing device, obtaining, by the computing device, historical operational context information associated with preceding operation of one or more of an infusion device and the sensing device, obtaining, by the computing device, historical values for a parameter from one or more of the infusion device and the sensing device, determining, by the computing device a patient-specific model of the parameter based on relationships between the historical measurements, the historical operational context information and the historical values, and providing, by the computing device via a network, the patient-specific model to one of the infusion device, the sensing device or a client device.

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 fluid reservoir for a fluid infusion device is provided. The fluid reservoir includes a first portion that has a first end and a second end. The first end includes a fluid delivery port and at least one bubble retaining feature adjacent to the fluid delivery port. The fluid reservoir includes a second portion received in the second end of the first portion and movable within the first portion from the first end to the second end. The fluid reservoir defines a fluid chamber between the first portion and the second portion.

Abstract: An insertion device for use with an insertion set is provided. The insertion device includes a first housing having a rail. The insertion device includes a hub having a first end coupled to the rail and a second end including a projection. The hub is movable relative to the first housing along the rail. The insertion device includes a locking carrier in the first housing and movable between a first position and a second position. The locking carrier is coupled to the projection in the first position and the projection is released in the second position. The insertion device includes a second housing coupled to the insertion set and surrounding at least a portion of the first housing to define a gap. The locking carrier is received in the gap in the second position to release the projection of the hub and to enable the insertion set to be uncoupled.

Abstract: Microneedle arrays, methods for fabricating microneedle arrays, medical devices, and methods for operating medical devices are provided. A method for fabricating a microneedle array includes providing a sheet blank of material. Further, the method includes stamping the sheet blank of material with a progression of dies, wherein the material is displaced into the microneedle array. A medical device includes a microneedle array, a base member having a first surface supporting the microneedle array and a second surface, and a flexible wall enclosing a chamber between the flexible wall and the second surface of the base member. The flexible wall is biased toward an extended configuration enclosing a first volume in the chamber. Further, the flexible wall is movable to a depressed configuration enclosing a second volume in the chamber less than the first volume.

Abstract: Microneedle arrays, methods for fabricating microneedle arrays, medical devices, and methods for operating medical devices are provided. A method for fabricating a microneedle array includes providing a sheet blank of material. Further, the method includes stamping the sheet blank of material with a progression of dies, wherein the material is displaced into the microneedle array. A medical device includes a microneedle array, a base member having a first surface supporting the microneedle array and a second surface, and a flexible wall enclosing a chamber between the flexible wall and the second surface of the base member. The flexible wall is biased toward an extended configuration enclosing a first volume in the chamber. Further, the flexible wall is movable to a depressed configuration enclosing a second volume in the chamber less than the first volume.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device capable of delivering fluid to a user involves obtaining a sequence of measurements indicative of a condition of the user that is influenced by the fluid and modifying one or more unusable measurements in the sequence using one or more other usable measurements in the sequence to obtain a modified sequence of measurements. The method continues by determining a predicted value for the condition of the user at a time in the future based at least in part on the modified sequence of measurements and operating the infusion device in a manner that is influenced by the predicted value.

Abstract: A system for filling a fluid reservoir of a fluid infusion device with a fluid is provided. The system includes the fluid reservoir having a first portion and a second portion. A fluid chamber is defined between the first portion and the second portion. The second portion is movable within the first portion and includes an interface. The system includes a transfer guard having a first end and a second end. The first end to be coupled to a source of the fluid and the second end having at least one locking member that couples to the interface. The transfer guard defines a fluid flow path for the fluid from the source, and the transfer guard is movable relative to the first portion to fill the fluid chamber with the fluid.

Abstract: A method of controlling an insulin infusion device is presented here. The method can be implemented in a suitably configured electronic device, on an electronic storage medium, or the like. In accordance with certain embodiments, the method evaluates the operational integrity of a glucose sensor that measures sensor glucose values for a user of the insulin infusion device, and calculates a sensor integrity metric based on the evaluation. The calculated sensor integrity metric is used to adjust the aggressiveness of a closed-loop therapy algorithm that is used to control a closed-loop operating mode of the insulin infusion device. The insulin infusion device is operated in the closed-loop operating mode in accordance with the adjusted therapy setting.

Abstract: A pump clip for a fluid infusion device is provided. The pump clip includes a clip base having a first end opposite a second end. The clip base defines an aperture through the clip base between the first end and the second end. The clip base is pivotable between a first position and a second position along a first pivot axis. The pump clip includes a clip pivot base coupled to the clip base along the first pivot axis. At least a portion of the clip pivot base is received within the aperture in the first position. The pump clip includes a clip coupled to the clip pivot base along a second pivot axis and the clip cooperates with the clip pivot base to receive an article.

Abstract: Medical devices and related patient management systems and parameter modeling methods are provided. An exemplary method of operating a sensing device associated with a patient involves obtaining current operational context information associated with the sensing device, obtaining a parameter model associated with the patient, calculating a current parameter value based on the parameter model and the current operational context information, obtaining one or more signals from a sensing element configured to measure a condition in a body of the patient, and providing an output that is influenced by the calculated current parameter value and the one or more signals.

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: The subject matter disclosed herein relates to systems, methods and/or devices for calibrating sensor data to be used in estimating a blood glucose concentration. A relationship between sensor measurements and reference readings may be used to estimate a relationship between sensor measurements and blood glucose concentration. Such sensor measurements may be weighted according to a decreasing function of uncertainty associated with sensor values.

Abstract: Medical devices and related patient management systems and event detection methods are provided. An exemplary method of detecting events pertaining to operation of a medical device, such as an infusion device, involves obtaining measurements indicative of a condition in a body of a patient, determining statistics for an analysis interval based on the measurements, and determining an event probability associated with the analysis interval based on historical event data associated with the patient. An event detection model associated with the patient is obtained and applied to the statistics and the event probability to identify occurrence of the event using the event detection model, and in response, an indication of the event associated with the analysis interval is provided, for example, by tagging or marking data in a database, displaying graphical indicia of the event, or the like.

Abstract: A fluid reservoir system is provided. The fluid reservoir system includes a fluid reservoir that defines a chamber to receive a fluid, and the fluid reservoir includes an outlet. The fluid reservoir system includes a source of pressure to draw the fluid into the outlet and a wicking membrane is coupled to the fluid reservoir that covers the outlet.

Abstract: Fluid injection devices and related systems and operating methods are provided. An exemplary injection device includes an actuation arrangement to facilitate delivering fluid from a container, a user interface element coupled to the actuation arrangement, a data storage element to maintain one or more patient-specific parameter values and historical bolus data, and a control module coupled to the actuation arrangement and the data storage element. The control module of the injection device determines a bolus amount of the fluid to be delivered based at least in part on the one or more patient-specific parameter values and the historical bolus data in response to receiving a user input indicative of a desire to administer a bolus, and the control module configures the actuation arrangement to automatically deliver the bolus amount in response to manual actuation of the user interface element.

Abstract: A protocol translation device for use with a first apparatus having a battery compartment and communicating over a first wireless protocol, and for use with a second apparatus communicating over a second wireless protocol. The protocol translation device can include a battery casing sized to fit within the battery compartment, the battery casing defining an interior volume; a translator having a first antenna operable to communicate with the first apparatus, a second antenna operable to communicate with the second apparatus, and a translator circuit operably connected between the first antenna and the second antenna; and a battery operably connected to power the translator. The translator circuit is operable to translate between the first wireless protocol and the second wireless protocol. The translator and the battery are disposed within the interior volume.