Abstract: Embodiments of the invention provide analyte sensors having elements designed to modulate their chemical reactions as well as methods for making and using such sensors. In certain embodiments of the invention, the sensor includes an analyte modulating membrane that comprises a blended mixture of a linear polyurethane/polyurea polymer, and a branched acrylate polymer.

Abstract: Disclosed are methods, apparatuses, etc. for glucose sensor signal purity analysis. In certain example embodiments, a series of samples of at least one sensor signal that is responsive to a blood glucose level of a patient may be obtained. Based at least partly on the series of samples, at least one metric may be determined to characterize one or more non-physiological anomalies of a representation of the blood glucose level of the patient by the at least one sensor signal. A reliability of the at least one sensor signal to represent the blood glucose level of the patient may be assessed based at least partly on the at least one metric. Other example embodiments are disclosed herein.

Abstract: A portable electronic device, such as a fluid infusion device, obtains its operating power from a primary battery and a secondary battery. The primary battery may be a replaceable battery, and the secondary battery may be a rechargeable battery that can be charged with the primary battery under certain conditions. The device utilizes a power management scheme that transitions between the primary battery and/or the secondary battery to prolong the useful life of the primary battery. The device may also generate an intelligent battery life indicator that displays an accurate representation of the remaining life of the primary battery.

Abstract: A sensor system includes a sensor and a sensor electronics device. The sensor includes a plurality of electrodes. The sensor electronics device includes a connection detection device, a power source, and a delay circuit. The connection detection device determines if the sensor electronics device is connected to the sensor and transmits a connection signal. The delay circuit receives the connection signal, waits a preset hydration time, and couples the regulated voltage from the power source to an electrode in the sensor after the preset hydration time has elapsed. Alternatively, the sensor electronics device may include an electrical detection circuit and a microcontroller. The electrical detection circuit determines if the plurality of electrodes are hydrated and generates an interrupt if the electrodes are hydrated. A microcontroller receives the interrupt and transmits a signal representative of a voltage to an electrode of the plurality of electrodes.

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: 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: A sensor system includes a sensor and a sensor electronics device. The sensor includes a plurality of electrodes. The sensor electronics device includes a connection detection device, a power source, and a delay circuit. The connection detection device determines if the sensor electronics device is connected to the sensor and transmits a connection signal. The delay circuit receives the connection signal, waits a preset hydration time, and couples the regulated voltage from the power source to an electrode in the sensor after the preset hydration time has elapsed. Alternatively, the sensor electronics device may include an electrical detection circuit and a microcontroller. The electrical detection circuit determines if the plurality of electrodes are hydrated and generates an interrupt if the electrodes are hydrated. A microcontroller receives the interrupt and transmits a signal representative of a voltage to an electrode of the plurality of electrodes.

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: A fluid syringe of the type used with fluid infusion devices is presented here. The fluid syringe generally includes a barrel, a piston, and a check valve seal. The barrel has an interior wall and a sealed main fluid chamber. The piston is slidably coupled within the barrel, and the piston has a piston seal forming an interference fluid seal against the interior wall. The check valve seal is coupled to the piston, and it is located between the piston seal and the main fluid chamber. The check valve seal forms an interference fluid seal against the interior wall when the piston is unloaded, and it disengages the interior wall to allow gas flow from the main fluid chamber toward the piston seal when the piston is loaded.

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: 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 apparatus for delivering a fluid includes a housing, an inlet in the housing for receiving the fluid, and an outlet in the housing for discharging the fluid. A piston channel is provided within the housing through which the fluid flows from the inlet to the outlet. An actuator is positioned within the housing and is moveable between a retracted position and a forward position, the actuator defining a piston chamber for storing fluid received through the inlet when the actuator is in the retracted position and for driving the fluid stored in the piston chamber toward the outlet when the actuator transitions from the retracted position to the forward position. The actuator includes an armature and a piston coupled to the armature and moveable within the piston channel. The piston is provided with a groove in an outer surface for conducting fluid from the inlet to the outlet.

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 angle relative to the skin of the patient upon movement of the carrier body from the retracted position to the advanced position.

Abstract: Embodiments of the invention provide methods and materials for making analyte sensors having a plurality of layered elements such as amperometric glucose sensors that are used by diabetic individuals to monitor blood sugar concentrations. Embodiments of the invention utilize plasma deposition technologies to form thin films of adhesion promoting compositions useful in such sensors. Sensors that incorporate the thin film compositions formed by these processes exhibit a number of desirable characteristics.

Abstract: An ambulatory medical device for detecting acceleration, temperature, and/or humidity conditions in or around the medical device is provided. The medical device includes one or more acceleration, thermal, and/or humidity sensors which detect acceleration, temperature, and/or humidity conditions in or around the medical device. In response to detected conditions, the medical device may, among other things, alter the operation of the device, provide an alarm or warning to the user, or transmit data about the detected conditions to another device.

Abstract: A relay device transfers information between a sensor system, which measures a physiological characteristic level of a user, and a fluid delivery system, which infuses a fluid into a user. The relay device includes a sensor system receiver for receiving communications from the sensor system in a sensor system format. The relay device also includes a processor for processing the communications from the sensor system and converting the communications for transmission in a delivery system format. The relay device further includes a delivery system transmitter for transmitting the converted communications in the delivery system format to the fluid delivery system. The sensor system and delivery system formats may utilize different frequencies and/or different communication protocols for communications transmitted between the sensor system and the fluid delivery system through the relay device.

Abstract: Disclosed are methods, apparatuses, etc. for glucose sensor signal stability analysis. In certain example embodiments, a series of samples of at least one sensor signal that is responsive to a blood glucose level of a patient may be obtained. Based at least partly on the series of samples, at least one metric may be determined to assess an underlying trend of a change in responsiveness of the at least one sensor signal to the blood glucose level of the patient over time. A reliability of the at least one sensor signal to respond to the blood glucose level of the patient may be assessed based at least partly on the at least one metric assessing an underlying trend. Other example embodiments are disclosed herein.

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 fluid infusion device, for delivery of a medication fluid to the body of a user, includes a housing, a fluid reservoir for the medication fluid, a dosing mechanism, an infusion component, and a mechanical actuator. The fluid reservoir and the dosing mechanism are located in the housing, and the dosing mechanism is coupled to receive the medication fluid from the fluid reservoir. The dosing mechanism has an adjustable fluid chamber that defines a variable dosage volume. The infusion component is coupled to the dosing mechanism to receive the medication fluid from the adjustable fluid chamber. The mechanical actuator is coupled to the dosing mechanism such that operation of the mechanical actuator causes the medication fluid to be expelled from the adjustable fluid chamber to the infusion component.

Abstract: A method of managing use of an insulin infusion device is presented here. The method identifies bolus calculator event data from glucose data for a user of the infusion device. The bolus calculator event data corresponds to use of a bolus calculator that calculates bolus dosage recommendations based on a user entered carbohydrate consumption value, a user entered current blood glucose value, a user specific carbohydrate ratio value, and a user specific insulin sensitivity value. The method filters the bolus calculator event data to remove glucose data associated with certain conditions, and analyzes the filtered data to detect an event occurrence that is indicative of potential maladjustment of the carbohydrate ratio value or the insulin sensitivity value. The method outputs a recommendation to adjust the carbohydrate ratio value or the insulin sensitivity value, based on characteristics of the detected event occurrence.