Abstract: A sensor for the detection or measurement of a carbohydrate analyte in fluid comprises components of a competitive binding assay the readout of which is a detectable or measurable optical signal retained by a material that permits diffusion of the analyte but not the assay components, the assay components comprising: a carbohydrate binding molecule labelled with one of a proximity based signal generating/modulating moiety pair; and a carbohydrate analogue capable of competing with the analyte for binding to the carbohydrate binding molecule, the carbohydrate analogue being a flexible water-soluble polymer comprising: polymerized or co-polymerised residues of monomer units, the monomer unit residues bearing pendant carbohydrate or carbohydrate mimetic moieties and pendant moieties which are the other of the proximity based signal generating/modulating moiety pair.

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: An insertion device and insertion set. The insertion device for inserting at least a portion of at least one piercing member of an insertion set through the skin of a patient includes a device housing, a carrier body and a driver. The carrier body is slidably received within the device housing for movement between an advanced position and a retracted position. The carrier body also includes a receiving structure to support the insertion set in a position with the at least one piercing member oriented for insertion through the skin of the patient at a predetermined or variable angle relative to the skin of the patient upon movement of the carrier body from the retracted position to the advanced position.

Abstract: Apparatus are provided for infusion devices and related control systems and methods. In one embodiment, an infusion device includes a voided portion adapted to receive a shaft portion that includes a shaft coupled to a plunger of a reservoir. The shaft portion includes a detectable feature having an optically detectable pattern such as gray code, and the infusion device includes a sensing arrangement having an optical sensor proximate the voided portion to sense the detectable feature. In some embodiments, a control module is coupled to the sensing arrangement to determine a remaining amount of fluid in the reservoir based at least in part on the sensed position of the detectable feature. In embodiments, the optical sensor detects the sensed position of the shaft based on the detectable feature only when the reservoir is replaced and/or after each delivery of fluid to reduce power consumption.

Abstract: A closed loop system or semi-closed loop system for infusing insulin using sensor values applies a redundant sensor system as a fail-safe method against sensor failure. The redundant glucose sensors are used corroborate each other and a failing sensor is detected if the sensors no longer corroborate each other. The use of redundant sensors has the additional benefit of producing better sensor signals compared to the use of a single sensor.

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 motor may be configured to drive a drive shaft and an engagement member supported on the drive shaft. A detectable feature comprising a rotary member may be supported on the drive shaft such that movement of the drive shaft by the motor changes a state of the detectable feature. At least one sensor may be arranged to detect the state of the detectable feature. Circuitry may be configured to provide a signal in response to a change in the state of the detectable feature detected by the at least one sensor.

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. Methods, systems, and articles of manufacture for automatically detecting an occlusion in a medication infusion pump are provided. The electrical current to an infusion pump may be measured. Based on measurements of one or more variables, such as force, the infusion pump detects whether there is an occlusion in the system. The methods of detecting occlusions may be dynamic.

Abstract: A controller for an insulin infusion device includes a processor device and a memory element that cooperate to provide a processor-implemented closed-loop insulin limit module. The insulin limit module is operated to obtain: a fasting blood glucose value of a user; a total daily insulin value of the user; and fasting insulin delivery data that is indicative of insulin delivered to the user during a fasting period. The insulin limit module calculates a maximum insulin infusion rate for the user based on the fasting blood glucose value, the total daily insulin value, and the fasting insulin delivery data. The maximum insulin infusion rate is applicable during a period of closed-loop operation of the insulin infusion device.

Abstract: A device for delivering fluid to a user includes a housing, a drive motor assembly in the housing, other internal components in the housing, and a keypad external to the housing. The device includes a number of features and elements that enhance its operation, manufacturability, reliability, and user-friendliness. These features and elements include a shock absorbing element for a battery of the device, a keypad actuator layer that overlies a keypad assembly and forms a water resistant seal with the housing, and an offset element for a piezoelectric speaker that is located inside the housing.

Abstract: An electronic device includes a processor architecture and a memory element that stores instructions that, when executed by the processor architecture, perform a method of controlling an insulin infusion device for a user. The method operates the device in a closed-loop mode to deliver insulin to the user, obtains current insulin-delivered data and current glucose sensor data for the user, and processes historical insulin-delivered data and historical sensor data, to obtain predicted sensor glucose values for a historical time period. The method continues by calculating a difference between the current sensor glucose value and a predicted current sensor glucose value for the most recent sampling period. An alert is generated when the difference exceeds a threshold error amount.

Abstract: Processor-implemented methods of controlling an insulin infusion device for a user are provided here. A first method obtains a current insulin on board (IOB) value that estimates active insulin in the user, and compensates a calculated insulin infusion rate in response to the obtained IOB value. A second method supervises the operation of a glucose sensor by obtaining and processing insulin-delivered data and glucose sensor data for the user. An alert is generated if the second method determines that a current glucose sensor value has deviated from a predicted sensor glucose value by at least a threshold amount.

Abstract: An electronic controller for an insulin infusion device includes at least one processor device and at least one memory element that cooperate to provide a processor-implemented closed-loop initiation module. The initiation module is operated to obtain a most recent calibration factor for a continuous glucose sensor, the most recent calibration factor representing a first conversion value applicable to convert a first sensor value to a first blood glucose value. The initiation module also obtains a prior calibration factor for the sensor, and calibration timestamp data for the most recent calibration factor and the prior calibration factor. The initiation module regulates entry into a closed-loop operating mode of the insulin infusion device, based on the most recent calibration factor, the prior calibration factor, and the calibration timestamp data.

Abstract: An electronic controller for an insulin infusion device includes a processor architecture and at least one memory element. The memory element stores executable instructions that, when executed by the processor architecture, provide an insulin on board (IOB) compensation module to estimate a current IOB value that indicates an amount of active insulin in the body of the user, calculate an IOB rate based at least in part on the estimated current IOB value, determine an adjusted insulin infusion rate based at least in part on the calculated IOB rate and an uncompensated insulin infusion rate, select a final insulin infusion rate for the device, and provide the selected final insulin infusion rate to regulate delivery of insulin by the device.

Abstract: A controller for an insulin infusion device includes at least one processor device and at least one memory element that cooperate to provide a processor-implemented closed-loop start-up module. The start-up module is operated to initiate a closed-loop mode of the infusion device and to obtain a most recent sensor glucose value for the user. The start-up module also calculates a difference between the most recent sensor glucose value and a target glucose setpoint value. When the difference is less than or equal to a threshold value, the closed-loop insulin infusion rate is adjusted over time, based on a fixed final target glucose value that is derived from the target glucose setpoint value. When the difference is greater than the threshold, the infusion rate is adjusted over time, based on a dynamic final target glucose value that decreases over time toward the target glucose setpoint value.

Abstract: Processor-implemented methods of controlling an insulin infusion device for a user are provided here. A first method obtains and analyzes calibration factors (and corresponding timestamp data) for a continuous glucose sensor, and regulates entry into a closed-loop operating mode of the infusion device based on the calibration factors and timestamp data. A second method obtains a most recent sensor glucose value and a target glucose setpoint value for the user at the outset of the closed-loop mode. The second method adjusts the closed-loop insulin infusion rate over time, in response to the sensor glucose value and the setpoint value. A third method calculates an upper insulin limit that applies to the insulin infusion rate during the closed-loop mode. The insulin limit is calculated based on a fasting blood glucose value of the user, a total daily insulin value of the user, and fasting insulin delivery data for the user.

Abstract: An infusion system that includes a controller device and a communication system to provide for two-way communication between the controller device and an infusion device that controls delivery of fluids to a user's body. Either the controller device or the infusion device may be integrated with a characteristic determining device in a single housing. The housing, in turn, may include a test-strip receptacle and an illuminator disposed so as to illuminate an area covering the receptacle and a test-strip inserted therein. The illuminator may be configured to be activated automatically when a test strip is inserted into the receptacle, selectively by the user via a button, key, or similar mechanism, and/or when the ambient light level, measured, e.g., with a light sensor, falls below a predetermined intensity. The illuminator may be a LED emitting white light, and may provide illumination at various levels of intensity.

Abstract: Apparatus are provided for motor control systems and related medical devices. In one embodiment, a control system includes a motor having a rotor, a sensor to obtain a measured displacement that is influenced by rotation of the rotor, and a control module coupled to the sensor. The control module adjusts a duty cycle for a modulated voltage applied to the motor in response to a difference between an expected displacement and the measured displacement. The expected displacement is influenced by or otherwise corresponds to a commanded rotation of the rotor.

Abstract: Apparatus are provided for infusion devices and related control systems and methods. In one embodiment, an infusion device includes a voided portion adapted to receive a shaft portion that includes a shaft coupled to a plunger of a reservoir. The shaft portion includes a detectable feature, and the infusion device includes a sensing arrangement proximate the voided portion to sense the detectable feature. In some embodiments, a control module is coupled to the sensing arrangement to determine a remaining amount of fluid in the reservoir based at least in part on the sensed position of the detectable feature. In other embodiments, the control module identifies an anomalous condition based at least in part on the sensed position of the detectable feature.

Abstract: Apparatus are provided for motor control systems and related medical devices. In one embodiment, a control system includes a motor having a rotor, a modulation module coupled to the motor, and a control module coupled to the modulation module. The modulation module generates a modulated voltage that is applied to the motor and rotates the rotor to deliver fluid via a fluid path. The control module adjusts a duty cycle of the modulated voltage to achieve a commanded rotation of the rotor and detects an occlusion condition in the fluid path based on the duty cycle.