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 disease management system, methods, and devices are shown and described. In one embodiment, the system includes an infusion pump and a remote controller with the ability to be paired to each other. A method to verify a wireless connection between an infusion pump and a remote controller is shown and described herein. In a further embodiment, a method to verify a wireless connection between an infusion pump and a remote controller is provided. In addition, a method of operating a diabetes management system is provided in which the system includes an infusion pump and at least a remote controller.

Abstract: Some embodiments of a portable infusion pump system can be configured to can be configured to adjust the sensitivity of particular detectors or alert systems based (at least in part) on information received from a monitoring device. For example, a glucose monitoring device can communication with an infusion pump assembly used to supply insulin or another medication to a user. In such circumstances, the data received from the monitoring device can be used to adjust the sensitivity of an occlusion detection system.

Abstract: Some embodiments an infusion pump system can be used to determine a user's total insulin load (TIL) that provides an accurate indication of the insulin previously delivered to the user's body which has not yet acted. In particular embodiments, the TIL can account for both the bolus deliveries and the basal deliveries that have occurred over a period of time. Such information may be useful, for example, when the infusion pump is operated in conjunction with a continuous glucose monitoring device.

Abstract: In one embodiment, an ambulatory insulin infusion system may include an administration module for insulin administration, a data collection module for collecting data relevant for the bolus amount, and a delay module. The administration module may administer insulin continuously according to a basal profile and a bolus on demand. The bolus has a bolus amount. The data collection module may be operatively coupled to the administration module. The delay module may trigger administration of the bolus a therapeutically significant delay interval after the data is collected.

Abstract: In example methods and systems described, a medical device can store information locally and in a separate database on a server, for example. If the device fails, or a patient is moved to a second device, information may be transferred to the second device such that the second device can resume a complex therapy at a point where the initial medical device left off. The data necessary to restart the complex therapy system may include certain underlying patient-specific parameters according to a model capturing the patient's physiological response to the medication in question. As a result, it is not necessary for the second device to restart the complex therapy or regress to an initial set of baseline assumptions.

Abstract: Some embodiments an infusion pump system can be used to determine a user's total insulin load (TIL) that provides an accurate indication of the insulin previously delivered to the user's body which has not yet acted. In particular embodiments, the TIL can account for both the bolus deliveries and the basal deliveries that have occurred over a period of time. Such information may be useful, for example, when the infusion pump is operated in conjunction with a continuous glucose monitoring device.

Abstract: Methods, systems and devices for sustained medical infusion of fluids are described. Some implementations describe portable infusion methods, systems and devices for selecting a pattern of fluid delivery. Some implementations describe skin securable insulin dispensing methods, systems and devices for selecting a delivery pattern according to the nutritional characteristics (e.g. glycemic index, GI, fat content, etc.) of caloric intake of the user.

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 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: Some embodiments of a portable infusion pump system can be configured to can be configured to adjust the sensitivity of particular detectors or alert systems based (at least in part) on information received from a monitoring device. For example, a glucose monitoring device can communication with an infusion pump assembly used to supply insulin or another medication to a user. In such circumstances, the data received from the monitoring device can be used to adjust the sensitivity of an occlusion detection system.

Abstract: Embodiments of the present disclosure include methods, systems and devices for selecting a bolus configuration and may include one or more of providing a user interface for selection of one or more user interface elements, where each element corresponds to a bolus configuration of a drug, each element is spatially positioned within a multi-dimensional space corresponding to at least three dimensions and the element's position corresponding to each dimension.

Abstract: An augmented, adaptive algorithm utilizing model predictive control (MPC) is developed for closed-loop glucose control in type 1 diabetes. A linear empirical input-output subject model is used with an MPC algorithm to regulate blood glucose online, where the subject model is recursively adapted, and the control signal for delivery of insulin and a counter-regulatory agent such as glucagon is based solely on online glucose concentration measurements. The MPC signal is synthesized by optimizing an augmented objective function that minimizes local insulin accumulation in the subcutaneous depot and control signal aggressiveness, while simultaneously regulating glucose concentration to a preset reference set point. The mathematical formulation governing the subcutaneous accumulation of administered insulin is derived based on nominal temporal values pertaining to the pharmacokinetics (time-course of activity) of insulin in human, in terms of its absorption rate, peak absorption time, and overall time of action.

Abstract: A method of programming an infusion device includes receiving an infusion rate for a time period, wherein the time period overlaps with a predefined start of a predefined period of the infusion device. The time period is converted into (1) a first converted time period extending from a start of the time period to the predefined start of the predefined period, and (2) a second converted time period extending from the predefined start of the predefined period to an end of the time period. The infusion device is programmed with the infusion rate for the first converted time period and the second converted time period.

Abstract: A system and methods are described for improving the management of ischemic cardiac tissue during acute coronary syndromes or other ischemic conditions. A method and apparatus is described that allows mitigation of oxygen-related injury by precisely modulating the level of oxygen re-exposure during reoxygenation by a controlled feedback loop based on parameters of the tissue measured by a real-time tissue sensor or probe.

Abstract: Methods and apparatuses for calculating and transmitting medication dosage or bolus information are provided. A blood glucose meter receives a test strip with a sample of the user's blood and measures the user's blood glucose level with a sensor. The meter then calculates a bolus amount that is transmitted to a medication infusion pump using a radio frequency transmitter or transceiver. The infusion pump receives the bolus amount data and then delivers a bolus of medication to the user based on the calculated bolus estimate. The meter may also transmit commands to, and be used to remotely control, the infusion pump.

Abstract: A device that delivers one or more substances into a vaginal lumen according to one of a plurality of release patterns. The device comprises a supporting structure, substance dispensers, and/or coupling elements which are configured to release one or more substances, for example, drugs, in manner designed to optimize treatment of one or more medical conditions.

Abstract: Method and apparatus for providing multiple data receiver units in a data monitoring and management system such as analyte monitoring system where a first data receiver includes all of the functionalities for the data monitoring and management system receiver unit, and a second data receiver unit is configured with a limited functions to provide application specific convenience to the user or patient is disclosed.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte.

Abstract: A medical device system includes a portable (patient-worn or patient-carried) medical device that can automatically initiate certain e-commerce and/or advertisement presentation features in response to the detection of one or more triggering events. A triggering even may, for example, be associated with the monitoring of the operation or status of the medical device, the operation or status of the medical device system, a medical condition of the patient, treatment of the patient, and/or the preferences of the patient or user. In one application, the medical device is an insulin infusion pump and the user is automatically prompted to purchase, order, or otherwise obtain replaceable or replenishable items associated with the operation of the insulin infusion pump, such as a continuous glucose sensor, an infusion set, or an insulin reservoir.

Abstract: A combination glucose measuring and insulin pumping device is described. The two major components, a glucose measuring module and an insulin pump, are held together by a quick attach and release mechanism. Communication between the glucose measuring module and the insulin pump is by a wireless modality. The glucose measuring module determines the glucose level in a sample, and wirelessly transmits the data to the insulin pump, where the data are stored in a memory, and are available for visual display on the insulin pump, and for incorporation into selection of appropriate protocols for the rate of insulin infusion by the pump into the patient.

Abstract: An infusion system, which may be a closed loop, or “semi-closed-loop”, infusion system, uses state variable feedback to control the rate at which fluid is infused into a user's body. The closed loop system includes a sensor system, a controller, and a delivery system. The “semi-closed-loop” system further includes prompts that provide indications to the user prior to fluid delivery. The sensor system includes a sensor for monitoring a condition of the user and produces a sensor signal which is representative of the user's condition. 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, e.g., subcutaneous insulin concentration, plasma insulin concentration, and insulin effect, and corresponding gains, to calculate an additional amount of fluid to be infused with a bolus and to be removed from the basal delivery of the fluid.

Abstract: Embodiments of the present disclosure present systems, devices and methods for ISF glucose monitoring that more accurately reflects the blood glucose levels by introducing a treatment element allowing stable and accurate prediction of blood glucose levels based measured glucose levels from interstitial fluid.

Abstract: Methods and apparatuses providing accessibility options for the blind and poorly sighted for use with insulin therapy systems. A remote control device, with speech output capability and comprehensive speech menu system, may monitor or intercept data generated by a blood glucose meter, and delay, modify and retransmit said data to an insulin pump. The remote control device may also be used to program and set operating parameters of an insulin pump and also record data received from an insulin pump. The remote control device may also be used in conjunction with a personal computing device.

Abstract: An exemplary includes acquiring an electroneurogram of the right carotid sinus nerve or the left carotid sinus nerve, analyzing the electroneurogram for at least one of chemosensory information and barosensory information and calling for one or more therapeutic actions based at least in part on the analyzing. Therapeutic actions may aim to treat conditions such as sleep apnea, an increase in metabolic demand, hypoglycemia, hypertension, renal failure, and corgestive heart failure. Other exemplary methods, devices, systems, etc., are also disclosed.

Abstract: Disclosed are methods, devices, systems and computer program products for communicating between at least one unit of a therapeutic fluid dispensing device and at least another unit of the dispensing device. The method includes performing a determination whether a first frequency can be used to transmit a message related to operations of the dispensing device, and transmitting the message based on the determination.

Abstract: Method and system for providing basal profile modification in insulin therapy for use with infusion devices includes periodically monitoring the analyte levels of a patient for a predetermined period of time in order to determine, based on the monitored analyte levels, an appropriate modification factor to be incorporated into the underlying basal profile which was running at the time the periodic monitoring of the analyte levels were performed.

Abstract: A modular external infusion device that controls the rate a fluid is infused into an individual's body, which includes a first module and a second module. More particularly, the first module may be a pumping module that delivers a fluid, such as a medication, to a patient while the second module may be a programming module that allows a user to select pump flow commands. The second module is removably attachable to the first module.

Abstract: A system and method for providing optimal insulin injections to a subject, using a controller, a continuous glucose monitor, and an insulin delivery unit is disclosed. The controller possesses a discrete-time, linear model predictive control law, means for sending information to the insulin delivery unit, and means for receiving information from the CGM. The control law implemented is derived from a discrete-time model of glucose insulin dynamics and an aggressiveness parameter. The result is that using only glucose measurements obtained from sensor readings and, prior values of external insulin infusion and meal and exercise announcement the optimal insulin injection necessary to safely regulate blood glucose can be calculated.

Abstract: A sensor is provided that is appropriate for transcutaneous detection of tissue or blood constituents. A sensor for tissue constituent detection may include a gas collection chamber with a conduit to a sensing component and a conduit from the sensing component to the chamber. A sensor as provided may also include a barrier layer to prevent water from infiltrating the sensor.

Abstract: Disclosed is a skin adherable device for delivering therapeutic fluid into a body of a patient. The device includes a monitoring apparatus, a dispensing apparatus, and a tip for delivering the therapeutic fluid into the body of the patient and for monitoring bodily analyte in the body of the patient. The dispensing apparatus may continuously deliver the therapeutic fluid to the body of the patient and the monitoring apparatus may continuously monitor bodily analytes of the patient.

Abstract: An infusion system, which may be a closed loop, or “semi-closed-loop”, infusion system, uses state variable feedback to control the rate at which fluid is infused into a user's body. The closed loop system includes a sensor system, a controller, and a delivery system. The “semi-closed-loop” system further includes prompts that provide indications to the user prior to fluid delivery. The sensor system includes a sensor for monitoring a condition of the user and produces a sensor signal which is representative of the user's condition. 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, e.g., subcutaneous insulin concentration, plasma insulin concentration, and insulin effect, and corresponding gains, to calculate an additional amount of fluid to be infused with a bolus and to be removed from the basal delivery of the fluid.

Abstract: A system for at least partial closed-loop control of a medical condition is disclosed. The system includes at least one medical fluid pump. The medical fluid pump including a sensor for determining the volume of fluid pumped by the pump. Also, at least one continuous analyte monitor, and a controller. The controller is in communication with the medical fluid pump and the at least one continuous analyte monitor. The controller includes a processor. The processor includes instructions for delivery of medical fluid based at least on data received from the at least one continuous analyte monitor.

Abstract: Some embodiments an infusion pump system can provide a suggested bolus dosage based on particular parameters (e.g., the user's recent blood glucose characteristics, food intake data, an amount of insulin already delivered to the user which has not yet acted on the user, or other factors). In some circumstances, the infusion pump system can receive information indicative of the user's blood glucose level and suggest an insulin bolus dosage that is at least partially dependent upon the recent rate of change in the user's blood glucose level. Such a feature can be helpful to a user when the infusion pump is operated in conjunction with a glucose monitoring device because the suggested bolus dosage can be at least partially based on recent data indicative of the user's blood glucose level.

Abstract: A method and system for the localized delivery of therapeutic agents to internal body tissues, especially the brain. In one aspect the invention is a method of delivering a therapeutic agent to a target location within an internal body tissue, the method comprising: charging the therapeutic agent; providing a plurality of polarizable microcatheters surrounding the target location; delivering the charged therapeutic agent between the microcatheters; and polarizing the microcatheters thereby generating an electrical field between the microcatheters that moves the charged therapeutic agent throughout the target location. In another aspect the invention is a system for carrying out the method.

Abstract: Some embodiments an infusion pump system can be configured to modify alarm limit parameters as the user's insulin load increases or decreases. Moreover, in particular embodiments, the infusion pump system can be configured to provide a “missed bolus” or “missed meal” alarm in response to the user's blood glucose characteristics, the user's insulin load information, or the like.

Abstract: The present invention is a method for delivering insulin to a subject to improve impaired hepatic glucose processing. The method delivers a series of pulses of insulin to the subject over a period of time accompanied by ingestion of glucose in the form of a carbohydrate containing meal. The amount of insulin in each pulse, the interval between pulses and the amount of time to deliver each pulse to the subject are selected so that the hepatic processing of glucose is restored in the subject. In subjects whose hepatic glucose processing has been restored there is a subsequent fall in circulating blood glucose levels of 50 mg/dl or more directly as a result of improved hepatic glucose processing.

Abstract: Methods, system and devices for monitoring a plurality of parameters associated with a closed loop control operation including continuously monitoring a physiological condition and automatic administration of a medication, detecting an impending administration of the medication level exceeding a predetermined threshold level, retrieving one or more signals associated with the monitored physiological condition, determining an accuracy indication of the retrieved one or more signals associated with the monitored physiological condition, and executing the administration of the medication level based on the accuracy indication are provided.

Abstract: Methods, system and devices for monitoring control parameters in a closed loop control operation including continuously monitoring glucose level and automatic administration of a medication, detecting a condition associated with hypoglycemia, determining whether a probability of the detected condition associated with hypoglycemia exceeding a threshold level, and outputting a notification based upon the determination are provided.

Abstract: A method, system, and computer program product related to the detection of physical activity using changes in heart rate. The method, system, and computer program product evaluates short term glucose demand and long term insulin action due to physical activity. The method, system, and computer program product is further related to the improvement of open and closed loop control of diabetes by accounting for the metabolic changes due to physical activity. The method, system, and computer program product is directed to detecting in real time the short and long term effects of physical activity on insulin action via heart rate analysis, and recommending changes in insulin dosing to compensate for the effects of physical activity. With these recommendations, the open and closed loop control of diabetes can be improved and steps can be taken to prevent hypoglycemia that may result from increased insulin sensitivity due to physical activity.

Abstract: Methods, system and devices for monitoring a closed loop control operation including signal levels received from an analyte sensor and automatic delivery of medication at least in part in response to the received analyte sensor signals, determining whether the signal level received from the analyte sensor is associated with one of a fault condition or a potential fault condition, and dynamically adjusting a current infusion rate executed by the closed loop control operation when it is determined that the signal level from the analyte sensor is associated with one of the fault condition or potential fault condition, where medication delivery rate is adjusted to a first predetermined range when the signal level is associated with the fault condition, and adjusted to a second predetermined range when the signal level is associated with a potential fault condition, and where the first predetermined range is narrower compared to the second predetermined range are provided.

Abstract: Methods, system and devices for monitoring a closed loop control operation including signal levels received from an analyte sensor and automatic delivery of medication at least in part in response to the received analyte sensor signals, determining whether the signal level received from the analyte sensor is associated with one of a fault condition or a potential fault condition, and dynamically adjusting a current infusion rate executed by the closed loop control operation when it is determined that the signal level from the analyte sensor is associated with one of the fault condition or potential fault condition, where medication delivery rate is adjusted to a first predetermined range when the signal level is associated with the fault condition, and adjusted to a second predetermined range when the signal level is associated with a potential fault condition, and where the first predetermined range is narrower compared to the second predetermined range are provided.

Abstract: Some embodiments an infusion pump system can be used to determine a user's total insulin load (TIL) that provides an accurate indication of the insulin previously delivered to the user's body which has not yet acted. In particular embodiments, the TIL can account for both the bolus deliveries and the basal deliveries that have occurred over a period of time. Such information may be useful, for example, when the infusion pump is operated in conjunction with a continuous glucose monitoring device.

Abstract: An automated method and system of diabetes control. The method includes establishing a blood glucose target for an insulin user, measuring an existing blood glucose level for the insulin user, and inputting the existing blood glucose level into a computer processor formed to execute an algorithm designed to calculate a corrective amount of insulin to be administered intravenously in an integrated basal-bolus manner to the insulin user if the existing blood glucose level exceeds the blood glucose target. The algorithm is based on a plurality of factors that contribute to a non-linear glucose response. The method further includes automatically delivering the corrective amount of insulin to the insulin user, and further repeating the measuring, inputting, and delivering steps one or more times to maintain the insulin user within the blood glucose target range.

Abstract: A system and process for providing safety limits on the delivery of an infusion formulation by an infusion pump system in response to a sensed biological state. The safety limits may comprise user-initiated event signals corresponding to events that may significantly affect the biological state. The safety limits may further comprise user-initiated event ranking signals for respective events which specify a degree, quantity, or measure for the respective event. The user-initiated event and event ranking signals may be communicated to a computing element associated with the infusion pump by an associated communication device having a user interface which comprises a plurality of user-selectable operators for entering information about the events and event rankings.

Abstract: A method of calculating doses of insulin for a person with diabetes and administering the calculated doses to the person with diabetes is presented. Blood glucose values are provided to an insulin dosing calculator which implements a Treat to Target protocol to calculate appropriate doses of insulin. An insulin dispenser is also provided to fill an insulin administration device with the calculated dose.

Abstract: An infusion system is for infusing a fluid into the body of a patient. The infusion system includes at least one sensor for monitoring blood glucose concentration of the patient and an infusion device for delivering fluid to the patient. The sensor produces at least one sensor signal input. The infusion device uses the at least one sensor signal input and a derivative predicted algorithm to determine future blood glucose levels. The infusion device delivers fluid to the patient when future blood glucose levels are in a patient's target range. The infusion device is capable of suspending and resuming fluid delivery based on future blood glucose levels and a patient's low shutoff threshold. The infusion device suspends fluid delivery when future blood glucose levels falls below the low shutoff threshold. The infusion device resumes fluid delivery when a future blood glucose level is above the low shutoff threshold.

Abstract: The present invention provides an electrochemical sensor having a sensing chemistry that operates substantially free of any “oxygen effect”. The electrochemical sensors are useful in determining the level of an analyte in a biological sample from a subject. The present invention also provides sensor assemblies including the electrochemical sensors as well as methods of using the same.

Abstract: A combination glucose measuring and insulin pumping device is described. The two major components, a glucose measuring module and an insulin pump, are held together by a quick attach and release mechanism. Communication between the glucose measuring module and the insulin pump is by a wireless modality. The glucose measuring module determines the glucose level in a sample, and wirelessly transmits the data to the insulin pump, where the data are stored in a memory, and are available for visual display on the insulin pump, and for incorporation into selection of appropriate protocols for the rate of insulin infusion by the pump into the patient.

Abstract: A blood glucose maintenance system for use by hyperglycemic individuals measures their blood glucose level and calculates an appropriate glucose or insulin dosage based on the measurement. Recheck intervals responsive to dosage history are determined. Warning or alert messages or signals are produced if certain measurements or calculations fall outside established normal ranges. It is particularly useful for patients in a hospital or in-patient environment.