Abstract: Embodiments of the invention provide a dual insertion set for supplying a fluid to the body of a patient and for monitoring a body characteristic of the patient. Typical embodiments of the invention include a base, an infusion portion coupled to a first piercing member and a sensor portion coupled to a second piercing member. The infusion portion includes a cannula coupled to the piercing member for supplying a fluid to a placement site. The sensor portion includes a sensor coupled to and extending from the base having at least one sensor electrode formed on a substrate and is coupled to the piercing member in a manner that allows the sensor to be inserted at the placement site. The base is arranged to secure the dual insertion set to the skin of a patient.

Abstract: An apparatus for monitoring a patient's blood glucose level. The apparatus includes an implantable medical device having a controller and an implantable heart sounds sensor configured to transmit signals to the controller of the implantable medical device. The controller is configured to determine if a patient is hypoglycemic or hyperglycemic based on the signals from the heart sounds sensor. A method is also disclosed that includes sensing the patient's heart sounds, determining the amplitude of the S2 heart sound, determining the length of the interval from the S1 heart sound to the S2max heart sound, determining the length of the interval from the S1 heart sound to the S2end heart sound, and determining the patient's blood glucose status based on the patient's heart sounds.

Abstract: Present invention is a system of blood glucose monitoring and intensive insulin therapy in a ICU for strict maintenance of normoglycemia which reduces intensive care and hospital mortality and morbidity of critically ill adult patients. The findings of present study also reveal factors determining insulin doses needed to maintain normoglycemia as well as the impact of insulin dose versus blood glucose level on the observed outcome benefits have been established. The invention provides a control system that adapts the flow of the insulin infusion based on insulin requirement calculated by blood glucose levels and clinical parameters such as history of diabetes, Body Mass Index, blood glucose level on admission, reason of ICU admission, time in the ICU, type and severity of illness, caloric intake, obesity, drugs affecting insulin sensitivity). This automated insulin monitoring systems significantly reduces the workload and human resource management problems for intensive insulin therapy in patients in the ICU.

Abstract: A device and a method are provided that can be used for prevention of hypoglycemia. In one aspect, a device and a method for prevention of hypoglycemia can comprise receiving a target blood glucose (TBG) level corresponding to a desired level of glucose in a patient's body during a fasting time period; receiving a bedtime blood glucose (BBG) level corresponding to the level of glucose in the patient's body substantially at the beginning of the fasting time period; receiving a first set of parameters corresponding to a medical state of the patient; providing the levels of the TBG, BBG and the medical state of the patent to a therapeutic course of action determining means; and, providing means for administering the therapeutic course of action to the patient.

Abstract: A protein is provided, including a glucose binding site, cyan fluorescent protein (CFP), and yellow fluorescent protein (YFP). The protein is configured such that binding of glucose to the glucose binding site causes a reduction in a distance between the CFP and the YFP. Substance monitoring apparatus (210) is also provided, including a semi-permeable barrier (212), adapted to be implanted in a body of a subject and to allow passage therethrough of a substance, while inhibiting passage therethrough of immune cells; and microorganisms (214), disposed within the semi-permeable barrier (212) so as to produce a measurable response to a level of the substance. A sensor (220) is adapted to measure the measurable response and not to measure a response of any mammalian cells that may be disposed within the semi-permeable barrier (212).

Abstract: A monitor device for a fluid infusion system and its operating, display, and data processing characteristics are described herein. One embodiment of the monitor device is used in an insulin infusion system having an insulin infusion pump and a continuous glucose sensor transmitter. The monitor device is configured as a wireless bedside monitor that wirelessly receives status data from a device in the fluid infusion system, such as the infusion pump or the sensor transmitter. The monitor device supports a number of user interface features, alarm/alert features, and graphical display features, where such features enhance the overall operation and user-friendliness of the monitor device. For example, the monitor device can generate status icons that graphically indicate the time remaining for an exhaustible operating quantity of a device in the infusion system (e.g., a battery charge, a fluid reservoir volume, or a calibration or replacement period).

Abstract: A volume of an analyte-enriched fluid can be withdrawn out of a user's subcutaneous compartment using a patch unit that includes a reversible pumping mechanism. The volume can be withdrawn out of the body and into the patch unit through a cannula inserted into the subcutaneous compartment so that an analyte concentration in the volume can be measured using a sensing element within the patch unit. After analyte concentration analysis, at least the volume can be delivered back into the subcutaneous compartment by operating the pumping mechanism in a forward direction. biologically compatible fluid can optionally be pumped into the subcutaneous compartment from a reservoir in the patch unit and then allowed to partially or completely equilibrate with the analyte concentration in the interstitial fluid of the subcutaneous compartment via a permeable or semi-permeable cannula surface before being drawn back into the patch unit for analysis. Related systems, apparatus, methods, and/or articles are also described.

Abstract: A process for the manufacture of small sensors with reproducible surfaces, including electrochemical sensors. One process includes forming channels in the surface of a substrate and disposing a conductive material in the channels to form an electrode. The conductive material can also be formed on the substrate by other impact and non-impact methods. In a preferred embodiment, the method includes cutting the substrate to form a sensor having a connector portion and a transcutaneous portion, the two portions having edges that define one continuous straight line.

Abstract: A closed loop/semi-closed loop infusion system provides therapy modification and safeguards against the over-delivery or under-delivery of insulin. A glucose sensor system is configured to obtain a measured blood glucose value. A controller is operationally connected with the glucose sensor system and configured to trigger an alarm based on a measured blood glucose value or amount of insulin delivered, selectively perform calibration of the glucose sensor system when the alarm is triggered, and adjust a therapy delivery parameter when the alarm is triggered, wherein the adjusted therapy delivery parameter is limited to be within a boundary. Thereafter, a delivery system delivers therapy at the adjusted therapy delivery parameter.

Abstract: An integrated system for the monitoring and treating diabetes is provided, including an integrated receiver/hand-held medicament injection pen, including electronics, for use with a continuous glucose sensor. In some embodiments, the receiver is configured to receive continuous glucose sensor data, to calculate a medicament therapy (e.g., via the integrated system electronics) and to automatically set a bolus dose of the integrated hand-held medicament injection pen, whereby the user can manually inject the bolus dose of medicament into the host. In some embodiments, the integrated receiver and hand-held medicament injection pen are integrally formed, while in other embodiments they are detachably connected and communicated via mutually engaging electrical contacts and/or via wireless communication.

Abstract: A four-part method for analyzing data of a patient's blood glucose (BG) tests or other parameters e.g. carbohydrate intakes and discrete insulin doses (boluses): 1. An LCD-button on the portable glucose meter or insulin pump, that allows flagging or assigning a category to each blood glucose test at test-time. Examples of categories: pre-meal BG tests, post-meal BG tests. 2. In the computer-based downloading program, features for changing the boundaries of the meal-oriented time-intervals by the faster methods of: a) mouse-dragging the time-boundary lines on a scatter chart, b) placing stretchable rectangles around the data points of interest. 3. Features in the computer-based downloading program, for digitally identifying the time of the meal and digitally assigning the category to the pre-meal BG tests and to the post-meal BG tests. 4.

Abstract: Methods and systems for providing modular components in an integrated infusion device and analyte monitoring system where the components are independently replaceable are provided.

Abstract: A closed loop infusion system controls the rate that fluid is infused into the body of a user. The closed loop infusion system includes a sensor system, a controller, and a delivery system. The sensor system includes a sensor for monitoring a condition of the user. The sensor produces a sensor signal, which is representative of the condition of the user. The sensor signal is used to generate a controller input. The controller uses the controller input to generate commands to operate the delivery system. The delivery system infuses a liquid into the user at a rate dictated by the commands from the controller. Preferably, the sensor system monitors the glucose concentration in the body of the user, and the liquid infused by the delivery system into the body of the user includes insulin.

Abstract: A disposable high density optically readable polydeoxynucleotide array with integral fluorescence excitation and fluorescence emission channels is described. The compact array size allows integration into several types of interventional devices such as catheters, guidewires, needles, trocars and may be used intraoperatively. Highly sensitive monitoring of the metabolic and disease pathways of cells in vivo under varying chemical, genetic and environmental conditions is afforded.

Abstract: The present invention comprises methods and apparatuses that can provide measurement of glucose and other analytes with a variety of sensors without many of the performance-degrading problems of conventional approaches. As apparatus according to the present invention comprises a blood access system, adapted to remove blood from a body and infuse at least a portion of the removed blood back into the body. Such an apparatus also comprises an analyte sensor, mounted with the blood access system such that the analyte sensor measures the analyte in the blood that has been removed from the body by the blood access system. A method according to the present invention comprises removing blood from a body, using an analyte sensor to measure an analyte in the removed blood, and infusing at least a portion of the removed blood back into the body. The use of a non-contact sensor with a closed system creates a system will minimal infection risk.

Abstract: A closed loop infusion system controls the rate that fluid is infused into the body of a user. The closed loop infusion system includes a sensor system, a controller, and a delivery system. The sensor system includes a sensor for monitoring a condition of the user. The sensor produces a sensor signal, which is representative of the condition of the user. The sensor signal is used to generate a controller input. The controller uses the controller input to generate commands to operate the delivery system. The delivery system infuses a liquid into the user at a rate dictated by the commands from the controller. Preferably, the sensor system monitors the glucose concentration in the body of the user, and the liquid infused by the delivery system into the body of the user includes insulin.

Abstract: A method and apparatus for reducing the workload of titrating drug to effect while leaving clinician users in control of a related procedure is described. A drug delivery device is controlled to achieve a target drug concentration at a selected site in the patient or a predetermined infusion rate waveform. The time profile of the target drug concentration or a predetermined infusion rate waveform is controlled by a drug state model that uses clinical heuristics to implement safe, pre-defined changes in the target drug concentration or infusion rate and user-commanded changes in target drug concentration or infusion rate. The invention allows time to assess the response of the patient to changes in drug level by making small incremental and conservative changes in drug level over time.

Abstract: A closed loop therapy system for controlling a concentration of a substance, such as blood glucose concentration, in the body of a user. The system and method employ a sensor system that measures a glucose level in the body, a controller that uses the measured glucose levels to generate an output that can be used to automatically or manually control an intradermal insulin infusion system to set a constant or time-varying profile of target blood glucose concentrations in a user, and then infuse an appropriate amount of insulin into the body of the user so as to reach and maintain the target values of the blood glucose concentration.

Abstract: Disclosed is a portable automatic insulin syringe device adapted to enable an injection of liquid medicine for a prolonged time, including a syringe pump having a pump housing, further including a blood sugar measuring unit mounted at one side of the pump housing and adapted to measure a blood sugar level of a user, a control unit for controlling the blood sugar measuring unit and the syringe pump, and a display unit for simultaneously displaying the quantity of insulin dispensed to a user and the blood sugar level measured by the blood sugar measuring unit.

Abstract: An apparatus for delivering a bolus of a medical agent to a patient. The apparatus comprises a pump mechanism, a data input device, and a processor in data communication with the keypad and arranged to control the pump mechanism. The processor is programmed to receive data specifying a bolus amount through the data port, receive data regarding duration through the data port, receive a percentage through the data port, the percentage defining a portion of the bolus amount to deliver immediately upon executing a deliver command and a remainder of the bolus amount to deliver over the duration upon executing a deliver command, and execute the deliver command thereby controlling the pump mechanism to deliver the bolus. Also a method of temporarily adjusting the delivery rate of an infusion pump. The infusion pump is programmed to deliver a basal rate.

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: Devices, systems and methods are provided for remotely controlling medication delivery to a patient by means of a medication infusion pump, such as a subcutaneous infusion pump, and for remotely controlling the monitoring of one or more physiological fluid analytes such as by a percutaneous measurement device. The systems of the present invention include a medication infusion pump and a hand-held “fob” for the remote control of the infusion pump and/or measurement device. In addition to remotely controlling the insulin pump and the measurement device, the fob provides for the consolidation of blood chemistry data and insulin delivery data over a period of time and maintains such consolidated data for immediate and later retrieval by the user or a physician. The methods of the present invention allow a user to customize and optimize an insulin bolus delivery protocol, i.e.

Abstract: A system is provided that enables glycemic control for a subject. The system includes an insulin delivery unit, a glucose sensor, and a control unit. The control unit includes a processor unit that receives glucose value readings from the glucose sensor, executes an algorithm that predicts a glucose value at a predetermined time in the future, compares that predicted glucose value to a pre-determined glucose value range, and determines a corrective amount of insulin to be administered when the predictive glucose value lies outside of the predetermined glucose value range. The control unit also includes a communication unit that transmits the corrective amount to the delivery unit.

Abstract: A system, including catheter apparatus, and related method for performing site specific therapy. The catheter apparatus can include one or more semipermeable microcatheters (preferably in the form of hollow fibers) for use in performing site specific microdialysis. The system and method are particularly suited for use in addressing cerebral edema by affecting the osmolar relationship between fluids making up the brain tissue. Also disclosed is an apparatus having a delivery/recovery mechanism in the form of a pump reservoir and one or more catheters in the form of semipermeable microcatheters, for use in delivering and/or recovering fluid to and/or from a tissue site or for performing tissue engineering outside of the body. The apparatus can be used in a method to perform site specific microtherapy, including for the treatment of compartment syndrome or cerebral edema.

Abstract: A pump assembly for ambulatory peritoneal dialysis transfer procedures includes a portable power supply geared to drive a high-volume peristaltic pump. A cassette of the pump comprises an encasement; tubing including an inner portion positioned within the encasement, a patient-side portion for connection to an indwelling peritoneal dialysis catheter and an opposing portion connectable to a system for containment and communication of a peritoneal dialysis solution which may be one single-compartment bag assembly; a safety valve for selectively occluding and permitting the communication of the solution through the inner portion; and a filter preferably interposed along the patient-side portion which filters air and particles from peritoneal dialysate that is flowing toward a patient and which allows peritoneal dialysate to flow substantially freely and unfiltered away from the patient.