Abstract: Described and illustrated is a system for management of diabetes that includes an infusion pump, glucose sensor and controller with a method programmed into the controller. The infusion pump is configured to deliver insulin to a subject. The glucose sensor is configured to sense glucose levels in the subject and provide output signals representative of the glucose levels in the subject. The controller is programmed to switchover from one mode of MPC control based on a predetermined range of blood glucose values to another MPC mode based on a predetermined target.

Abstract: Methods and systems for controlling an insulin pump in response to glucose measurements are responsive to a base insulin delivery profile and a temporary insulin delivery profile. These can be used, e.g., to control blood glucose level of a subject using a continuous glucose monitor and an insulin infusion pump. During a selected time range, an insulin amount for the pump to supply is determined using the temporary insulin delivery profile. Outside that time range, the insulin amount is determined using the base insulin delivery profile. The temporary insulin delivery profile can specify an exact amount to be supplied (a “hard” profile), a nominal amount to be supplied if doing so does not drive glucose out of a desired zone (“soft”), or a soft profile with a minimum amount of insulin to be delivered (“semi-soft”).

Abstract: Described and illustrated is a diabetes management system that includes an infusion pump, glucose sensor and controller with a method programmed into the controller. The infusion pump is configured to deliver insulin to a subject. The glucose sensor is configured to sense glucose levels in the subject and provide output signals representative of the glucose levels in the subject. The controller is programmed to receive signals from at least one of the glucose sensor and the pump and configured to issue signals to the pump to deliver an amount of insulin determined by a feedback controller that utilizes a model predictive control and also configured to deliver at least the basal amount of insulin whenever the subject has initiated a manual bolus of insulin and a sensed or measured glucose level is at least a first threshold within a first duration of time.

Abstract: Described is drug infusion device and lineset for delivering medication. The novel pump and lineset described herein eliminate the ability of the pump and lineset from being primed when the cartridge reservoir is in fluid communication with the drug-delivering cannula, through which medication is delivered, is inserted into the skin of a patient. The system and method of the invention include a lineset having a plurality of electrical leads for allowing electrical communication between the infusion pump and the infusion set and for allowing the pump to determine whether the lineset is connected to the infusion set when a priming operation is initiated.

Abstract: Described is a drive mechanism for a drug infusion pump. In one embodiment, an in-line drive mechanism is provided that includes a motor operatively coupled to a lead screw, which is configured to engage a piston. The piston includes a cavity to receive the motor and the lead screw such that the lead screw and at least a portion of the motor are substantially contained within the piston cavity when the piston is in a retracted position. In one embodiment, the motor rotates a drive shaft is configured to turn a mechanism comprising a piston, a lead screw, and a housing that cooperate to extend telescopically to drive a plunger into a medicament cartridge, thereby expelling fluid.

Abstract: A local extremum of a function ƒ is determined by computing a Jacobian of ƒ at a test point x by adding an imaginary part to x and a Hessian of ƒ by adding two imaginary parts to a multicomplex copy of x and extracting a third imaginary part. Solving a system of equations defined by the Jacobian and Hessian yields a delta; the process is repeated until convergence. This method is used in each of a series of time intervals to compute an insulin-delivery amount for an insulin pump. ƒ is a model-predictive-control cost function; x is a set of successive candidate insulin delivery amounts beginning from a selected time interval. A system includes a glucose monitor and a controller using glucose measurement data therefrom to determine an insulin delivery amount for a time interval by minimizing ƒ; an insulin pump provides insulin corresponding to the delivery amount.

Abstract: Described and illustrated is a system for management of diabetes that includes an infusion pump, glucose sensor and controller with a method programmed into the controller. The infusion pump is configured to deliver insulin to a subject. The glucose sensor is configured to sense glucose levels in the subject and provide output signals representative of the glucose levels in the subject. The controller is programmed receives signals from at least one of the glucose sensor and the pump and configured to issue signals to the pump to deliver an amount of insulin determined by a feedback controller that utilizes a model predictive control of the subject based on desired glucose levels, insulin amount delivered and measured glucose levels of the subject. The controller is also configured to deliver insulin using a tuning factor based on either one of an omission index module or a calibration index module.

Abstract: A glucose measurement system includes a display and a biosensor that provides a signal representative of a glucose level of a fluid sample. A processor determines glucose data values and a rate of change of blood glucose using the signal. The processor can determine a state band and a rate band using the values and rate, and display a state icon colored per the state band and a rate icon colored and shaped per the rate band. The processor does not display any other indication of the determined rate of change or of any of the stored glucose data values. The processor can also display a unified icon shaped per the rate of change, with a prevailing color determined using the values. The processor does not display any other indication of the determined rate of change or of any of the stored glucose data values. Corresponding methods are also described.

Abstract: Described and illustrated is a system for management of diabetes that includes an infusion pump, glucose sensor and controller with a method programmed in the controller. The infusion pump is configured to deliver insulin. The glucose sensor senses glucose levels in the subject and provide output signals representative of the glucose levels in the subject. The controller is programmed receives signals from at least one of the glucose sensor and the pump and configured to issue signals to the pump to deliver an amount of insulin determined by a feedback controller that utilizes a model predictive control based on desired glucose levels, insulin amount delivered and measured glucose levels of the subject. The controller is also configured to deliver insulin using a tuning factor (R) for a model predictive controller in the microcontroller as a conservative setting otherwise the system maintains a current tuning factor (R) for the controller.

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 and to confirm the authenticity of instructions sent to the infusion device from the remote controller. A method to verify a wireless connection between an infusion pump and a remote controller is shown and described herein. 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: A self-contained hand-held test device for the single-use determination of an analyte (such as glucose) in a bodily fluid sample (for example, a whole blood sample) includes a housing with proximal and distal ends, a housing cap configured for removable attachment to the distal end of the housing, a single analytical test strip (e.g., a single electrochemical-based analytical test strip) disposed partially in the housing and extending from the distal end thereof, a meter module disposed in the housing, and a lancing module attached to the proximal end of the housing. The lancing module is configured to lance a user's target site (such as a fingertip or other suitable site) for the expression of a bodily fluid sample. In addition, the single analytical test strip has a bodily fluid sample application portion and a meter module contact portion and is operably connected to the meter module in user irreplaceable manner.

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: Described and illustrated is a system for management of diabetes that includes an infusion pump, glucose sensor and controller with a method programmed in the controller. The infusion pump is configured to deliver insulin. The glucose sensor senses glucose levels in the subject and provide output signals representative of the glucose levels in the subject. The controller is programmed receives signals from at least one of the glucose sensor and the pump and configured to issue signals to the pump to deliver an amount of insulin determined by a feedback controller that utilizes a model predictive control based on desired glucose levels, insulin amount delivered and measured glucose levels of the subject. The controller is also configured to deliver insulin using a tuning factor (R) for a model predictive controller in the microcontroller as a conservative setting otherwise the system maintains a current tuning factor (R) for the controller.

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: Described is novel system for delivering medication to a patient via an infusion pump. The infusion pump includes mechanical means for delivering medication that are locked and unlocked via a remote control device. The remote control device is configured to be programmed with a desired dosage of medication and to unlock the infusion device to permit the patient, user, or healthcare provider to mechanically deliver only the desired amount of medication by turning a dial. Once the desired dosage of medication has been manually delivered, the remote control locks the infusion device.

Abstract: Described is drug infusion device with one or more vents that permit the passage of gas between the exterior and interior of the device's housing. In one embodiment the device may include multiple interior chambers of differing volume and pressure sensors placed between them, while vents to ambient pressure are included in each chamber. According to this exemplary structure, the readings from the pressure sensor may be used to determine malfunctions in the venting of the device and/or changes in pressure that could cause the unintended delivery of medication.

Abstract: The invention is generally directed toward a novel fluid cartridge for medical infusion devices. The disclosed invention describes a medicament cartridge having an internal vent structure and hydrophobic venting material to permit the equilibration of pressure between an infusion device's reservoir chamber and the external environment, without the need for a costly, difficult to maintain vent located in the housing of the infusion device.

Abstract: An infusion device for delivering discrete boluses of medication to a patient, using a mechanically actuated piston. The infusion pump employs a near-field communication system to convey the occurrence of an actuation, the amount of medicament remaining in the pump, and other information to a nearby near-field receiver device. The disclosed drive system and nearer-field communications system provides an infusion device capable of accurately delivering medication and providing a means for tracking and logging data while eliminating the need for a power source within the device, thereby minimizing weight and size.

Abstract: The invention provides an insertion device for insertion of conduits into a body that, before and following deployment of the conduit into the body, has no components that require insertion into or removal from the device. Additionally, the device includes a component that not only prevents re-use or reopening of the device once it is activated, but also provides feedback to the user in the form of a resistance force to activation that must be overcome by the user to deploy the conduit.

Abstract: A local extremum of a function ƒ is determined by computing a Jacobian of ƒ at a test point x by adding an imaginary part to x and a Hessian of ƒ by adding two imaginary parts to a multicomplex copy of x and extracting a third imaginary part. Solving a system of equations defined by the Jacobian and Hessian yields a delta; the process is repeated until convergence. This method is used in each of a series of time intervals to compute an insulin-delivery amount for an insulin pump. ƒ is a model-predictive-control cost function; x is a set of successive candidate insulin delivery amounts beginning from a selected time interval. A system includes a glucose monitor and a controller using glucose measurement data therefrom to determine an insulin delivery amount for a time interval by minimizing ƒ; an insulin pump provides insulin corresponding to the delivery amount.