Abstract: Systems and methods are provided which enable communications to be initiated locally relative to an individual's developing physiological condition and remotely as the condition requires. Physiological sensors and associated medical delivery systems can be coupled to a unit wearable by an individual which can provide various audible or visual outputs and one or more manual inputs indicative of the individual's condition. A global positioning unit can be incorporated so that condition information as well as location information can automatically be provided, wirelessly, to a remote monitoring system for follow up as needed.

Abstract: Devices and systems for injecting fluids and/or other materials into a targeted anatomical location, in particular, a joint or intra-articular space, include a handpiece assembly having a needle extending from its distal end, a fluid delivery module comprising a cassette and a fluid transfer device. A conduit is generally configured to place the fluid delivery module in fluid communication with the handpiece assembly. Medicaments, formulations and/or other fluids or materials contained within vials that are secured to a cassette or other portion of the fluid delivery module can be selectively delivered into an anatomy through a needle located at the distal end of the handpiece assembly. In some embodiments, ultrasound or other imaging technologies can be used to locate a joint or other targeted anatomical location.

Abstract: An improved diagnostic analyte monitoring device has partially retractable hollow guide needles for the intradermal placement of diagnostic elements fixedly connected to measuring means within this device obviating the need to remove the guide needle and to connect the diagnostic elements to measuring means after placement into the skin. A flexible surface adhering to the skin serves for the subcutaneous implantation of the diagnostic elements within the guide needles and partial retraction of the guide needles exposes the active surface to body fluid, actuated by means designed for easy handling and safe operation. Concentration-time profiles of endogenous and exogenous analytes measured with the device are used to improve drug treatment modalities on an individualized basis.

Abstract: Systems and methods for processing sensor data are provided. In some embodiments, systems and methods are provided for calibration of a continuous analyte sensor. In some embodiments, systems and methods are provided for classification of a level of noise on a sensor signal. In some embodiments, systems and methods are provided for determining a rate of change for analyte concentration based on a continuous sensor signal. In some embodiments, systems and methods for alerting or alarming a patient based on prediction of glucose concentration are provided.

Abstract: Methods and apparatuses for monitoring and regulating physiological states and functions are disclosed. Several embodiments include application of one or more microelectrode arrays to a dorsal root ganglion for measurement of sensory neuron activity, or stimulation of sensory reflex circuits. The methods and apparatuses can be used, for example, for monitoring or controlling bladder function in a patient.

Abstract: Apparatus and method support the configuration and testing of therapy parameters for a medical device system in the treatment of nervous system disorders. With the embodiment, the medical device system operates in a manual treatment therapy mode, in which the medical device system evaluates a set of information that is indicative of a system configuration. The medical device system determines if the set of information is acceptable. During the manual treatment therapy mode, the medical device system applies therapeutic treatment to a patient in accordance with the set of information. If the patient cannot tolerate the therapeutic treatment, the user indicates so through a user interface. The medical device system may associate the patient's intolerance to therapeutic treatments that equal or exceed the patient's level of tolerance. Moreover, the medical device system may use this information to prevent a delivery of therapeutic treatment that exceeds the patient's level of tolerance during a run mode.

Abstract: The subject matter disclosed herein provides a response to a dose of a substance and/or controls the administration of the dose. In one aspect, there is provided a system. The system may include a processor and at least one memory configured to provide a response determinator. The response determinator may receive therapeutic and wellness data. Moreover, the response determinator may determine a response based on the received therapeutic and wellness data. The response may represent a reaction to a substance integrated with an ingestible event marker. The determined response may be provided to, for example, a therapy controller. Related systems, methods, and articles of manufacture are also described.

Abstract: Disclosed is a drug injection device, comprising a drug delivery module and an analyte measurement module, such as a blood glucose meter. The injection device may include a support for receiving a reservoir or a cartridge, a drive means for expelling the fluid from the reservoir or cartridge, and an injection means fluidically coupled to the reservoir or cartridge. Additionally, the injection device comprises an analyte measurement module. Medical systems including embodiments of the injection device are also disclosed.

Abstract: Tools and techniques for the rapid, continuous, invasive and/or noninvasive measurement, estimation, and/or prediction of a patient's intracranial pressure. In an aspect, some tools and techniques can predict the onset of conditions such as herniation and/or can recommend (and, in some cases, administer) a therapeutic treatment for the patient's condition. In another aspect, some techniques employ high speed software technology that enables active, long term learning from extremely large, continually changing datasets. In some cases, this technology utilizes feature extraction, state-of-the-art machine learning and/or statistical methods to autonomously build and apply relevant models in real-time.

Abstract: Techniques are used for adaptation of drug-administration parameters that control insulin delivery in a blood glucose control system. One technique provides long-term adaptation of a nominal basal infusion rate, adapting to longer-term changes in a patient's needs due to growth, illness, hormonal fluctuations, physical activity, aging, etc. Another technique provides adaptation of priming dose size at mealtimes for overall better glycemic control and also adapting to longer-term changes in a patient's needs. Adaptation calculations use a receding-horizon window of recent values of the adapted parameter. Doses of a counter-regulatory agent (e.g., glucagon) may also be delivered in response to information about estimated accumulation of exogenously infused insulin (subcutaneously, intramuscularly, intraperitoneally, or intravenously) and/or the effect insulin might have on glucose levels (blood glucose concentration or interstitial fluid glucose concentration).

Abstract: A functional adhesive bandage includes an adhesive layer and a cover layer. A sensor for measuring a vital parameter, a control unit, an energy storage device, and an actuator are arranged between the adhesive layer and the cover layer. The control unit is configured to evaluate the vital parameter measured by the sensor. The control unit is further configured to regulate the actuator based on the evaluation.

Abstract: A method for achieving tight glycemic control in a patient in need thereof is disclosed. The method comprises deploying an equilibrium glucose sensor within a blood vessel in the patient, coupling the sensor to a monitor that displays the blood glucose concentration, and administering a blood glucose regulator when the blood glucose concentration varies outside of the predetermined concentration range. The blood glucose regulator is administered in an amount sufficient to return the blood glucose concentration to within the predetermined concentration range, thereby achieving tight glycemic control.

Abstract: A system for administering a therapeutic agent to a subject; for administering a first pharmaceutically-acceptable taggant to the subject at least substantially concurrent with the therapeutic agent, the first pharmaceutically-acceptable taggant having a pharmacokinetic profile; and for administering a second pharmaceutically-acceptable taggant to the subject with the first pharmaceutically-acceptable taggant, the second pharmaceutically-acceptable taggant having a pharmacokinetic profile different from the pharmacokinetic profile of the first pharmaceutically-acceptable taggant.

Abstract: A medical device system and method that includes sensing a heart sound signal from a first external sensor, determining whether a pulmonary hypertension signature is detected in response to the sensed heart sound signal, sensing a lung sound signal from a second external sensor, determining whether a heart failure signature is detected in response to the sensed lung sound signal, and determining therapy parameters in response to determining whether a pulmonary hypertension signature is detected and determining whether a heart failure signature is detected.

Abstract: A metabolite monitoring system comprising a microdialysis probe including a semi-permeable membrane and a probe flow path passing from an inlet through a sensing volume adjacent to said semi-permeable membrane to an outlet, a fluid delivery device for delivering dialysate to said inlet; and a metabolite monitoring system associated with said outlet for monitoring a concentration of at least one metabolite in said dialysate from said microdialysis probe, wherein said fluid delivery device is configured to deliver a pulsed flow of said dialysate to said inlet.

Abstract: An apparatus and a system for controlling and/or managing administration of a drug to a body of a patient. The apparatus includes a drug infusion device configured to deliver drug at a predetermined location in the body of the patient, at least one sensor disposed in the drug infusion device and configured to measure a, corresponding property related to the patient and selected from the group consisting of physiological properties, biochemical properties, environmental properties and drug-related properties, a controller disposed in the drug infusion device and configured to receive from the at least one sensor data representative of the measured corresponding property and based on the received data, determine a drug delivery rate. The drug delivery device is configured to deliver the drug to the body of the patient based on the determined drug delivery rate.

Abstract: Various embodiments relating to a method of controlling the blood pressure of a subject is provided, the method includes generating blood pressure data indicating the blood pressure of the subject, controlling a plurality of pumps to infuse, in dependence on the blood pressure data, drugs into the subject, wherein each of the plurality of pumps is adapted to infuse one out of a plurality of different drugs into the subject, and wherein each of the plurality of different drugs has a particular influence on the blood pressure of the subject, wherein the plurality of pumps is controlled such that, in dependence on the blood pressure data, a mix of drugs is infused into the subject which stabilizes the blood pressure of the subject.

Abstract: The health state of a subject is automatically evaluated or predicted using at least one implantable device. In varying examples, the health state is determined by sensing or receiving information about at least one physiological process having a circadian rhythm whose presence, absence, or baseline change is associated with impending disease, and comparing such rhythm to baseline circadian rhythm prediction criteria. Other chronobiological rhythms beside circadian may also be used. The baseline prediction criteria may be derived using one or more past physiological process observation of the subject or population of subjects in a non-disease health state. The prediction processing may be performed by the at least one implantable device or by an external device in communication with the implantable device. Systems and methods for invoking a therapy in response to the health state, such as to prevent or minimize the consequences of predicted impending heart failure, are also discussed.

Abstract: A system for delivering or withdrawing a fluid to or from the body of a patient in a manner that permits delivery to be controlled based upon feedback from the patient, the system including a syringe assembly providing a syringe operably coupled to one or more sensors adapted to determine one or more corresponding parameters associated with fluid delivery and/or withdrawal, and a monitor adapted to be communicably associated with the one or more sensors of the syringe assembly, and optionally with other sensors or inputs providing additional parameters as well, the monitor comprising one or more read out mechanisms either directly or indirectly corresponding to the one or more fluid delivery/withdrawal parameters, and optionally with one or more of the additional parameters as well.

Abstract: Embodiments provide a continuous monitor of a patient's oxygenation and/or respiration coupled to a device configured to stimulate the patient's respiratory drive and/or summon medical assistance. In embodiments, there are provided systems, devices, and methods to assist in preventing patients from overdosing themselves with narcotics post-surgery. In embodiments, an apnea prevention device (APD) may utilize a commercially available pulse oximeter and/or a respiratory monitor to continuously monitor a patient's level of oxygenation/respiration. Should a patient develop respiratory depression or apnea and begin to desaturate, an APD may, using a proprietary method, trigger a sequence of staged responses to reverse worsening hypoxia.

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 adverse condition associated with the monitored physiological condition or the medication administration deviating from a predetermined safety level of the closed loop control operation, and initiating a non-zero pre-programmed medication delivery rate are provided.

Abstract: A glucose measuring system includes a glucose meter that incorporates wireless communication capabilities. The meter can advantageously be a low cost meter by eliminating expensive components, such as the display. The user nevertheless is able to retrieve and view his or her glucose values by referring to displays within the glucose measuring local area network. Feedback via these displays can advantageously be used by the diabetic to create a higher level of confidence and safety.

Abstract: A fluid injection system includes: a first apparatus which is attached to a human body and injects a fluid into the human body; and a second apparatus which is attached to a wrist of the human body and remotely controls the first apparatus, wherein the second apparatus includes an entry section accepting an entry of an operation command to the first apparatus and a first communicating section transmitting the operation command to the first apparatus, and the first apparatus includes a second communicating section receiving the operation command, a storing section storing the fluid, and a transporting section transporting the fluid from the storing section and injecting the fluid into the human body based on the operation command.

Abstract: A method of programming an ambulatory infusion pump from a computer. The ambulatory infusion pump is programmed to execute a delivery program, and the delivery program is driven by operating parameters. The method comprises generating a table on the computer, the table containing a row, the row having a plurality of cells, each cell in the row relating to a different operating parameter for the delivery program; entering an operating parameter into at least one of the cells; and downloading the operating parameters into the pump.

Abstract: The present disclosure involves a system for monitoring patients, and more specifically post-operative patients receiving narcotics/sedatives/opioids, and a novel apparatus for automatically delivering one or more substances such as a reversing agent, including but not limited to the agent commonly known as naloxone, in response to dangerous respiratory conditions such as respiratory depression or other undesired consequences caused by reaction to another dosage being delivered to the subject.

Abstract: Systems and methods for using physiological data in a medical device are disclosed. The physiological data may be measured by a vital sign reader and received by a processing circuit associated with the medical device. The processing circuit may automatically adjust the operation of the medical device during a medical procedure based on the physiological data. In some implementations, the processing circuit may mirror a memory partition to a redundant storage device, allowing for uninterrupted execution of the medical procedure in the event of a memory failure condition.

Abstract: A system for controlling an environment of a patient undergoing an surgical procedure is provided. The system includes a conduit configured to channel fluids towards the patient, a sensor configured to measure at least one operating parameter of the fluid being channeled to the patient, an effector configured to change the operating parameter of the fluid, and a controller configured to selectively activate the effector based on a signal received from the sensor.

Abstract: The present invention relates to a device for detecting the potential formation of a thrombus in a patient on a ventricular assist device. The device uses an energy source and sensor to detect changes in rheology of the patient.

Abstract: Systems and methods are disclosed for adjusting the delivery times of an insulin delivery profile of an insulin pump, wherein the insulin pump is operable to automatically deliver insulin to a person having diabetes based on an operating time of the internal clock and a delivery time of an insulin delivery profile. The method may comprise receiving a local time zone time from an external local clock, determining whether the operating time of the internal clock differs from the local time zone time by at least a first predetermined amount of time, requesting the person provide a time adjustment value when the operating time of the internal clock differs from the local time zone time by at least the first predetermined amount of time, receiving the time adjustment value from the person, and adjusting the delivery times of the insulin delivery profile based on the time adjustment value when received.

Abstract: Inhalation measurement systems and methods enable, during inhalant exposure, substantially real-time respiratory measurements of a test subject using techniques that obtain measurements of respiration directly from that test subject, instead of from inhalation chamber parameter measurements. Direct test subject respiratory measurements may be, by way of example only, impedance measurements. These respiratory measurements taken directly from the test subject may be transmitted, wirelessly for example, for processing during the course of the test to a processing system to determine a cumulative volume of inhalant inspired by the test subject. From that, a cumulative amount of inhalant (or dose) inspired by the test subject may be determined during the course of the inhalation compound test.

Abstract: A system and method for introducing one or more stimulating drugs and/or applying electrical stimulation to the brain to treat mood and/or anxiety disorders uses an implantable system control unit (SCU), specifically an implantable signal/pulse generator (IPG) or microstimulator with one or more electrodes in the case of electrical stimulation, and an implantable pump with one or more catheters in the case of drug infusion. In cases requiring both electrical and drug stimulation, one or more SCUs are used. Alternatively and preferably, when needed, an SCU provides both electrical stimulation and one or more stimulating drugs. In a preferred embodiment, the system is capable of open- and closed-loop operation. In closed-loop operation, at least one SCU includes a sensor, and the sensed condition is used to adjust stimulation parameters.

Abstract: An apparatus comprises one or more physiological sensing circuits that generate a sensed physiological signal and at least one of the physiological sensing circuits is implantable, a measurement circuit configured to recurrently measure one or more physiological parameters that indicate a status of heart failure of the subject, a comparison circuit configured to compare the one or more physiological parameter measurements to one or more physiological parameter target values, a therapy circuit configured to control delivery of one or more drugs to treat heart failure, and a control circuit in electrical communication with the comparison circuit and the therapy circuit and configured to recurrently adjust delivery of drug therapy according to the comparison of the measured physiological parameters to the physiological parameter targets.

Abstract: The present invention generally relates to radio-enabled devices for detection and remedy of biological and chemical warfare attack. More particularly, this invention relates to an on-body apparatus that provides a means of treatment which is innocuous to the wearer, but capable of injecting antidotes within seconds and preferably also combines multiple means of sensing chemical and biological agents as well as monitoring user's physiological response to the antidotes thereby to enable tailored and continuous infusion of antidotes while minimizing the side effect of the antidotes themselves. A key embodiment of this invention is the incorporation of an electronically-controlled needle or cannula that will deploy only when commanded to. When not deployed, the device sits inertly against the patient's skin, affixed by adhesive and or elastic materials.

Abstract: The subject matter disclosed herein provides a response to a dose of a substance and/or controls the administration of the dose. In one aspect, there is provided a system. The system may include a processor and at least one memory configured to provide a response determinator. The response determinator may receive therapeutic and wellness data. Moreover, the response determinator may determine a response based on the received therapeutic and wellness data. The response may represent a reaction to a substance integrated with an ingestible event marker. The determined response may be provided to, for example, a therapy controller. Related systems, methods, and articles of manufacture are also described.

Abstract: An automated therapy system having an infusion catheter; a sensor adapted to sense a patient parameter; and a controller communicating with the sensor and programmed to control flow output from the infusion catheter into a patient based on the patient parameter without removing fluid from the patient. The invention also includes a method of controlling infusion of a fluid to a patient. The method includes the following steps: monitoring a patient parameter with a sensor to generate a sensor signal; providing the sensor signal to a controller; and adjusting fluid flow to the patient based on the sensor signal without removing fluid from the patient.

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: A medical infusion system which increases adenosine triphosphate from carbohydrates by a pump delivering precisely timed and calculated boluses of hormones such as insulin resulting in oscillations of hormones in whole blood sufficient to cover a carbohydrate load equal to no less than forty percent (40%) of the minimum daily allowance for carbohydrates where the blood glucose is from 60 mg/dl to 300 mg/dl. The system comprises a pump and optimally a cassette or cartridge where the plunger rotates as it advances in reference to the cartridge to provide additional accuracy and overcome the forces of inertia and slip-stick as well as eliminate backlash. The system can also use an encoded area and an opening for connection to an infusion tube with an in-line sensor area where sampling probes can be located to optimized adenosine triphosphate production from the mitochondria in the cells.

Abstract: The present invention provides a system and method for controlling resuscitation in a patient. In at least one embodiment, the invention includes a fluid rate measurer, a controller electrically coupled to the fluid rate measurer, and a pump. The controller is adapted to receive signals from a physiological monitor and controls the pump.

Abstract: A handheld diabetes manager has a flight mode that cooperatively interacts with an external medical device and includes a port configured to receive a test strip for blood glucose measurement, a blood glucose measurement module operable with the test strip, a communications module and a user interface module. The communications module selectively communicates wirelessly with an external medical device. The user interface module communicates with the blood glucose measurement module and the communications module and operates to provide a graphical user interface on a display of the diabetes manager. The graphical user interface includes a screen with a flight mode option. When the flight mode option is enabled and the external medical device is paired and currently communicating with the diabetes manager, the user interface module interacts with the communication module to send a command to the external medical device to turn off wireless communication of the external medical device.

Abstract: Described is an infusion pump comprising electronic infusion regulating means with wired or wireless communication means and a power source, a medicament bag (7) and an infusion device, said infusion device being in fluid communication with said medicament bag (7) and comprising two valves (1, 2), a pressure cavity (4) provided between said two valves (1, 2) and a membrane (3) covering said cavity (4), wherein said infusion device comprises at least two active actuators, preferably either made of electroactive polymer so as to form a self actuating membrane (3) or made of shape memory alloy wire, one of said actuators being adapted to apply pressure to said membrane (3) for fluid displacement in said cavity (4), and the other of said actuators being adapted to operate one of said valves which is adapted to passively close in the flow direction of a fluid from said medicament bag (7) through the cavity (4), wherein the other of said valves is adapted to, in particular passively, close in a direction opposite t

Abstract: A balloon catheter for delivering a therapeutic and/or diagnostic agent to tissue is described including an outer balloon having a wall with an opening therethrough and an inner surface, an inner balloon disposed in the outer balloon, enclosing an inflation chamber and having an outer surface defining a space between the outer surface of the inner balloon and the inner surface of the outer balloon, a catheter having a first lumen in fluid communication with the space between the inner balloon and the outer balloon for supplying the agent thereto, and a second lumen through which fluid is supplied to the inflation chamber for inflating the inner balloon to urge the agent out of the opening in the outer balloon, wherein the outer balloon and/or the inner balloon comprise at least one protrusion for directing the agent formed by an inner balloon wall and/or the outer balloon wall.

Abstract: Disclosed are methods and apparatus for determining analyte concentration in a sample such as bodily fluid. Systems and methods disclosed herein can also include a treatment dosing system to infuse or inject a treatment drug (e.g., insulin or glucose) and provide glycemic control. The dose of the treatment drug may be based on the concentration of the analyte or the average value for the concentration of the analyte and/or the rate of change of the value of the concentration of the analyte.

Abstract: Receivers, which may be external or implantable, are provided. Aspects of receivers of the invention include the presence of one or more of: a high power-low power module; an intermediary module; a power supply module configured to activate and deactivate one or more power supplies to a high power processing block; a serial peripheral interface bus connecting master and slave blocks; and a multi-purpose connector. Receivers of the invention may be configured to receive a conductively transmitted signal. Also provided are systems that include the receivers, as well as methods of using the same. Additionally systems and methods are disclosed for using a receiver for coordinating with dosage delivery systems.

Abstract: A system and method for monitoring and delivering medication to a patient includes a controller that has a control algorithm and a closed loop control that monitors the control algorithm. A sensor is in communication with the controller and monitors a medical condition. A rule base application in the controller receives data from the sensor and the closed loop control and compares the data to predetermined medical information to determine the risk of automation of therapy to the patient. The controller then provides a predetermined risk threshold where below the predetermined risk threshold automated closed loop medication therapy is provided. If the predetermined risk threshold is met or exceeded, automated therapy adjustments may not occur and user/clinician intervention is requested.

Abstract: A naso/orogastric device having backflow blocking means and comprises a naso/orogastric tube sized and shaped for being disposed within the esophagus so that at least a distal end thereof being placed in the stomach lumen of a patient, at least one elastic esophageal body, positioned along the naso/orogastric tube, having a pressure dependent volume, at least one esophageal sensor that detects fluid around at least one segment of the naso/orogastric tube, and a pressure regulator that regulates a pressure within the elastic esophageal body according to the detection.

Abstract: An infusion system, which may be a closed loop infusion system or “semi-closed-loop” system, uses state variable feedback to control 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 “semi-closed-loop” system further includes prompts that are displayed or sounded or otherwise provide indications to the user prior to fluid delivery. 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 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, subcutaneous insulin concentration, plasma insulin concentration, and insulin effect, and corresponding gains, to calculate an additional amount of fluid to be infused as a bolus and to be removed from the basal delivery of the fluid.

Abstract: Disclosed are a universal adapter for the personal health device (PHD) standardization of a non-standardized healthcare device and an operating method thereof. The universal adapter includes: an adapter interface device communicating with a non-standardized healthcare device, which does not follow PHD standardization, to collect measurement data measured by the non-standardized healthcare device; and a universal adapter device receiving the measurement data from the adapter interface device, generating a PHD standard message including the received measurement data, and transmitting the PHD standard message to a PHD gateway according to a PHD standard communication scheme.

Abstract: Some embodiments of an infusion pump system can include a controller in which one or more features sets to be provided by the controller are enabled or disabled based upon the particular pump device that is connected to the controller. For example, in some embodiments, one or more advanced features of the controller are available to the user only when a first type of pump device (e.g., having predefined settings stored therein) is connected to the controller, and those advanced features of the controller are disabled when a second type of pump device is connected to the controller.

Abstract: A medical device, such as an infusion pump, obtains a contextual awareness of its operation by communicating with centralized patient records and or other medical equipment communicating with a common patient, and/or provides real time advisory information, at care point or remotely. A protocol obtained by the medical device from a protocol server provides context-aware protocols and necessary predicate information for those protocols. This predicate information may be discovered by the medical device communicating with electronic medical records and the associated medical equipment.

Abstract: Systems, devices, and methods for monitoring an analyte in a subject.