Abstract: The present invention provides a system and method for determining and maintaining a concentration level of medication in a patient sufficient to achieve and maintain a desired effect on that patient. Generally speaking, in accordance with one embodiment of the invention, a medication delivery controller uses a patient response profile to determine a concentration of medication in the patient that will achieve the desired effect on the patient. The patient response profile is a graphical, tabular or analytical expression of the relationship between the concentration of a medication and the effect of the medication at the specific concentration. Using this information, the medication delivery controller provides instructions to a medication delivery unit such as, for example, an infusion pump or inhalation device, to deliver the medication to the patient at a rate that will achieve the desired concentration level of the medication in the patient.

Abstract: Computerized oral prescription administration (COPA) devices, systems, and methods are provided. In one embodiment, a substance dispensing apparatus includes a mouthpiece having a recess sized and shaped to mate with an intended user's dentition; a sensing element coupled to the mouthpiece and configured to determine whether the intended user's dentition is positioned within the recess; and an actuator coupled to the mouthpiece and in communication with the sensing element, the actuator configured to dispense a substance from a reservoir coupled to the mouthpiece in response to the sensing element determining that the intended user's dentition is positioned within the recess.

Abstract: A system and method for monitoring and delivering medication to a patient. The system 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 based 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. A system monitor is also in communication with the controller to monitor system, remote system, and network activity and conditions. 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 digital electronic fetal heart rate and uterine contraction monitoring system with an electronic fetal monitor, a contraction monitoring sensor and a fetal heart rate sensor. A controller configured to receive fetal heart rate data and uterine contraction pressure, identify a contraction start time and end time, and calculate each rest interval in seconds between contractions. The system compares rest intervals to a safe preset limit for rest intervals, calculates a median rest interval and an average rest interval for each fifteen-minute period of labor, and presents a contraction and rest interval graph to a display. The system can activate an alarm on an electronic fetal monitor display or a third party display and can pause a pump that is delivering a drug to increase uterine contractions when a significant criteria of excessive uterine activity is detected outside preset limits to assure adequate blood flow to the fetal brain.

Abstract: A method and apparatus are provided for automatically detecting the type of replacement fluid loaded by the operator during a therapeutic exchange procedure and to provide a warning alarm if an incorrect fluid is used. After the operator connects the container of replacement fluid to the replacement fluid line of a single-use kit and enters into the controller an identification of the exchange procedure to be performed, the replacement fluid is flowed through a segment of the kit in proximity to a sensor associated with the hardware component that detects the type of fluid flowing through the segment. The controller verifies whether the replacement fluid detected in the segment corresponds to that appropriate for the selected exchange procedure, and notifies the operator in the event that an incorrect replacement fluid has been loaded.

Abstract: Systems and methods for epicardial electrophysiology and other procedures are provided in which the location of an access needle may be inferred according to the detection of different pressure frequencies in separate organs, or different locations, in the body of a subject. Methods may include inserting a needle including a first sensor into a body of a subject, and receiving pressure frequency information from the first sensor. A second sensor may be used to provide cardiac waveform information of the subject. A current location of the needle may be distinguished from another location based on an algorithm including the pressure frequency information and the cardiac waveform information.

Abstract: In embodiments, devices, computer-readable media, and methods for personal health device transcoding may be described. A transcoding module may serve as an interface between a manager device implementing an IEEE 11073-20601 (“IEEE 11073”) standard and a personal health device that does not implement the standard. The transcoding module may be configured to interact with one or more models of an IEEE 11073 stack implemented by the manager device. The transcoding device may be configured to redirect requests from the models and emulate responses from the personal health device such that the personal health device appears, to the manager device, to implement the IEEE 11073 standard. The transcoding module may perform the emulation asynchronously, through transcoding of communications with the personal health device, or may synchronously generate responses on behalf of the personal health device. Other embodiments may be described.

Abstract: In the present invention, a method and accompanying system for evaluating alarm events generated by patient monitors includes the steps of receiving a plurality of alarm events and associated alarm event data from one or more patient monitors at a central control unit, storing the alarm event data in an electronic storage medium, calculating an acuity score for the patient monitor from the alarm event data and a customizable rule set input into and stored in the control unit, the rule set applied to the alarm event data and comparing the calculated acuity score to a threshold value for the acuity score.

Abstract: Method of monitoring a control operation of a medication delivery system, determining whether a signal level received from an analyte sensor is associated with a fault condition and a potential fault condition, and adjusting a medication delivery rate executed by the control operation when it is determined that the signal level from the analyte sensor is associated with one of the fault condition or the potential fault condition, where the 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 the potential fault condition is provided. Devices, systems and kits for implementing the afore-mentioned method are also provided.

Abstract: An ECG monitoring system for ambulatory patients includes a battery-powered ECG monitor which attaches to a patient to receive patient electrical signals. A processor continuously processes received ECG signals and stores the signals in memory in the monitor. A wireless transceiver in the ECG monitor transmits the processed ECG signals to a cellphone handset. The battery of the monitor is recharged when the monitor is properly positioned in a charging dock, during which time the ECG signals are sent to the cellphone handset. Preferably the cellphone handset is recharged by the charging dock at the same time. At the conclusion of recharging and data transfer the monitor performs a self-test. A light on the charging dock is illuminated if any of the operations performed while the monitor is docked is unsuccessful.

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 method and apparatus for injecting saline into an open cavity of a patient's body, and, alternatively, vacuuming fluids from said cavity, during laparoscopic surgery that provides constant feed and amplified pressure to provide a steady fluid output, in a disposable, single use handheld surgical device.

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: Devices, systems and methods for controlling, regulating, altering, transforming or otherwise modulating the delivery of a substance to a delivery site. The devices, systems and methods optimize the delivery of the substance to an intended site, such as a vessel, vascular bed, organ and/or other corporeal structures, while reducing inadvertent introduction or reflux substance to other vessels, vascular beds, organs, and/or other structures, including systemic introduction.

Abstract: A phacoemulsificator for the removal of lens tissue, wherein the phacoemulsificator contains: a power source configured to provide pulsed electrical power, and a pump configured to provide vacuum, characterized in that the phacoemulsificator contains at least one eye ring connectable to the pump wherein the proximal end of said eye ring is suitable to be applied onto an ocular globe and means to generate ultrasound beam connectable to the power source wherein said means are fixed on the distal end of the eye ring.

Abstract: In embodiments, devices, computer-readable media, and methods for personal health device transcoding may be described. A transcoding module may serve as an interface between a manager device implementing an IEEE 11073-20601 (“IEEE 11073”) standard and a personal health device that does not implement the standard. The transcoding module may be configured to interact with one or more models of an IEEE 11073 stack implemented by the manager device. The transcoding device may be configured to redirect requests from the models and emulate responses from the personal health device such that the personal health device appears, to the manager device, to implement the IEEE 11073 standard. The transcoding module may perform the emulation asynchronously, through transcoding of communications with the personal health device, or may synchronously generate responses on behalf of the personal health device. Other embodiments may be described.

Abstract: A method for organizing care for a patient undergoing a peritoneal dialysis therapy under a system including at least one display device, at least one memory device, at least one processor and at least one peritoneal dialysis instrument for performing the peritoneal dialysis therapy, the method comprising: organizing information for presentation in a plurality of screens using the at least one display device, the at least one memory device, and the at least one processor, wherein each screen presents information pertinent to a particular aspect of the peritoneal dialysis therapy; and displaying in the plurality of screens information about the patient's prescription for the peritoneal dialysis therapy, information about medication the patient is taking in connection with the peritoneal dialysis therapy, and information about the patient's compliance with the peritoneal dialysis therapy.

Abstract: Apparatuses and methods for training users of ambulatory medical devices. The methods relate to improving user interactions with the touchscreens of devices. In one embodiment there is an operating mode that records all user interactions along with various device parameters and allows the clinician to review the patient's performance for the initial use period. Automated analysis software may be employed to analyze the data generated by the device. The results of the analysis may be used by the clinician to improve the patient and device interaction.

Abstract: A measurement system may comprise a sensor wire and a transceiver unit. The sensor wire may comprise an insertable portion configured to be inserted in a blood vessel of a patient's body and a sensor disposed within the insertable portion at a distal end of the senior wire. The sensor is configured to measure a parameter when inserted inside the patient. The transceiver unit may comprise: a housing adapted to be connected to a proximal end of the sensor wire; and a first communication module within the housing adapted to wirelessly communicate by a communication signal with an external second communication module in order to transfer information to the external second communication module.

Abstract: The present invention provides systems and methods for supporting encrypted communications with a medical device, such as an implantable device, through a relay device to a remote server, and may employ cloud computing technologies. An implantable medical device is generally constrained to employ a low power transceiver, which supports short distance digital communications. A relay device, such as a smartphone or WiFi access point, acts as a conduit for the communications to the internet or other network, which need not be private or secure. The medical device supports encrypted secure communications, such as a virtual private network technology. The medical device negotiates a secure channel through a smartphone or router, for example, which provides application support for the communication, but may be isolated from the content.

Abstract: A hydration monitoring device and system for recording and controlling an individual's hydration includes an improved fluid flow sensor configured to measure a quantity of fluid transferring from a reservoir to a user in a first fluid flow direction only.

Abstract: The present invention provides compositions useful for cardiac therapy comprising a cyclin-associated agent. The present invention also provides kits for use in delivering a cyclin-associated agent to cardiac cells in a subject, comprising the composition of the present invention and a catheter. The present invention additionally provides a methods for enhancing cardiac function; promoting regeneration of cardiac tissue; inducing endogenous myocardial regeneration; and preventing or treating heart failure in a subject in need thereof by augmenting cyclin in cells.

Abstract: A medical device module for use in a system with a remote programmer and/or a personal data assistant (PDA) with at least one medical device includes a housing, at least one medical device and a processor. The housing is adapted to couple with the PDA. The at least one medical device interface is coupled to the housing for interfacing with the at least one medical device. The processor is coupled to the at least one medical device interface to process data from the at least one medical device. The processor is also capable of interfacing with the PDA.

Abstract: The invention provides methods and systems for evaluating a fluid transfer event between a parenteral fluid delivery and a patient. The evaluation of the fluid transfer event can be prospective real-time and/or historic, as desired, and take a variety of different formats.

Abstract: The subject invention provides an improved bypass circuit for use in adult and especially pediatric cardiac surgery. The auto regulating capability of this circuit design simplifies its operation and combines the benefits of both VAVD and KAVD systems while eliminating the need for multiple blood pumps. Advantageously, this system occupies less space than existing systems, requires the use of less blood, reduces the contact between blood and tubing, reduces damage to blood cells, eliminates the need for multiple blood pumps and also reduces the incidence of gaseous emboli.

Abstract: Methods and systems for controlling analyte levels are described. An example method may include receiving a sensor measurement relating to an eye-mountable device. The method also may include determining an analyte concentration based on the one or more sensor measurements, and comparing the analyte concentration to a target analyte concentration. Based on the comparing, the method further may include providing instructions to a drug delivery device, where the instructions are configured to control a drug delivery rate by the drug delivery device.

Abstract: The present invention relates to a device for detecting a state of true perception loss of a human, the device including processing means operable to detect from information on electrical signals sensed adjacent to the scalp of the human the activity of oscillations present in the electrical signals as a marker for the state of true perception loss of the human.

Abstract: A system for treating heart disease, such as pulmonary hypertension or right heart failure, including an implantable component and external components for monitoring the implantable component is provided. The implantable component may include a compliant member, e.g., balloon, coupled to a reservoir via a conduit. Preferably, the compliant member is adapted to be implanted in a pulmonary artery and the reservoir is adapted to be implanted subcutaneously. The external components may include a clinical controller component, monitoring software configured to run a clinician's computer, a patient monitoring device, and a mobile application configured to run on a patient's mobile device.

Abstract: The invention is about a next-generation blood pump that provides pulsatile blood flow, and has been developed for cardiopulmonary by-pass devices used for maintaining extracorporeal blood circulation during heart surgeries and the supportive devices of circulation system. This device is technically a sort of synchronous power-assisted motor employing direct driver technology. The mentioned blood pump contains a rotor rotating on a magnetic bearing without a shaft and through the helical wings placed into the rotor it provides pulsatile blood supply adequate for the body requirement synchronous with the ECG signals received from the patients. It provides a patient safer and controlled pulsatile blood flow while running at high efficiency.

Abstract: Novel tools and techniques for assessing, predicting and/or estimating effectiveness of fluid resuscitation of a patient and/or an amount of fluid needed for effective resuscitation of the patient, in some cases, noninvasively.

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: 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: A patient data capture and processing system comprises: a programmable, platform medical device comprising at least one patient sensor interface; a processor coupled to said sensor interface and to a communications interface; programmable memory, coupled to said processor. The memory is programmable via the communications interface to define a plurality of different patient sensing functions to implement, in software, a plurality of different medical devices. A patient medical device controller comprises a further communications interface coupled to the communications connection; a processor; memory, coupled to said processor, storing signal processing code to retrieve the medical device data from one or more of the programmable platform medical devices via the communications connection, to filter clinically significant events from said retrieved medical device data to detect clinically significant events, and to output the filtered data for one or both of storage and review by a physician.

Abstract: Injection systems powered, controlled and network-enabled by a mobile device, and methods for powering and controlling an injection system using a mobile device, are disclosed. An injection device includes a fluid container having a fluid container exit port, an injection driving element adapted to displace fluid from the fluid container through the fluid container exit port, and a connection module connected to the injection driving element, connectable to a mobile device, and adapted to receive electrical power or injection input data from the mobile device.

Abstract: A method, computer program product, and infusion pump assembly for determining a first rate-of-change force reading that corresponds to the delivery of a first dose of an infusible fluid via an infusion pump assembly. At least a second rate-of-change force reading is determined that corresponds to the delivery of at least a second dose of the infusible fluid via the infusion pump assembly. An average rate-of-change force reading is determined based, at least in part upon the first rate-of-change force reading and the at least a second rate-of-change force reading.

Abstract: In one embodiment, an IDDC system utilizes an intelligent therapeutic agent delivery system comprised of one, but more likely an array of “cells” containing therapeutic agent(s) and/or diagnostic agents(s); an integrated bio-sensing system designed to sample and analyze biological materials using multiple sensors that include both hardware and software components. The software component involves biomedical signal processing to analyze complex liquid mixtures and a microcontrollers) acts as interface to the biosensors, to the therapeutic delivery elements, and to a communications system(s) for the purpose of controlling the amount of therapeutic agent to deliver and also to provide information in a useful form to interested parties on the progress of therapy and compliance thereto.

Abstract: A system and method for patient-adaptive hemodynamic management is described. One embodiment includes a system for hemodynamic management including transfusion, volume resuscitation with intravenous fluids, and medications, utilizing monitored hemodynamic parameters including the described dynamic predictors of fluid responsiveness, and including an intelligent algorithm capable of adaptation of the function of the device to specific patients.

Abstract: The present invention is directed to an electrochemical sensor involving an electrode and a coating that surrounds the electrode, the coating comprising a structural component, a water immiscible solvent, a resistance decreasing component, and an ion exchange component, wherein the coating selectively partitions an electrochemically active drug from a fluid or vapor sample whereby an electrochemical signal within the coating can be measured using the electrode. Devices and methods for using this electrochemical sensor are also disclosed.

Abstract: Wireless systems and methods include a plurality of peripheral electronic devices each having a wireless communication system. A processor is configured to establish an association confidence level indicative of a likelihood that a peripheral electronic device is associated to a monitored subject for each peripheral electronic device based on association criteria. Indicators are configured to communicate the association the association confidence level.

Abstract: A device for regulating cerebrospinal fluid in a cerebrospinal fluid space includes a cerebrospinal conduit having a distal end for insertion into the cerebrospinal fluid space in fluid communication with the cerebrospinal fluid. An actively oscillatably changeable sealed fluid volume can be in fluid communication with the cerebrospinal conduit. The changeable sealed fluid volume can be in a sealed fluid path extending to the distal end of the cerebrospinal conduit and is capable of actively oscillating in a changing fluid volume size for oscillating the cerebrospinal fluid in and out of the distal end of the cerebrospinal conduit and cerebrospinal fluid space.

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: System, devices and methods are presented that integrate stretchable or flexible circuitry, including arrays of active devices for enhanced sensing, diagnostic, and therapeutic capabilities. The invention enables conformal sensing contact with tissues of interest, such as the inner wall of a lumen, a nerve bundle, or the surface of the heart. Such direct, conformal contact increases accuracy of measurement and delivery of therapy.

Abstract: Methods of regulating blood glucose levels using an insulin pump are disclosed. A method includes receiving a current blood glucose level, and determining whether the current blood glucose level is above a threshold value. The method also includes calculating a correction bolus value based upon the current blood glucose.

Abstract: A needle-free transdermal transport device for transferring a substance across a surface of a biological body includes a reservoir for storing the substance, a nozzle in fluid communication with the reservoir and a controllable electromagnetic actuator in communication with the reservoir. The actuator, referred to as a Lorentz force actuator, includes a stationary magnet assembly and a moving coil assembly. The coil assembly moves a piston having an end portion positioned within the reservoir. The actuator receives an electrical input and generates in response a corresponding force acting on the piston and causing a needle-free transfer of the substance between the reservoir and the biological body. The magnitude, direction and duration of the force are dynamically controlled (e.g., servo-controlled) by the electrical input and can be altered during the course of an actuation cycle. Beneficially, the actuator can be moved in different directions according to the electrical input.

Abstract: An apparatus and system diabetes management.

Abstract: The invention discloses a detection and therapeutic device and remote monitoring shoes. The detection and therapeutic device comprises a power supply module (a) which is connected with modules with electricity needs and used for powering the modules, a main processor module (b) which is used for collecting and processing signals from sensors and controlling working status of an automatic injection module (d), a detection sensor module (c) which comprises a plurality of sensors in connection with the main processor module (b) and is used for examining nerves, organs or secretions and sending back the results to the main processor module (b), an automatic injection module (d) which comprises a plurality of automatic injectors in connection with the main processor module (b) and is used for administrating according to signals for controlling from the main processor module automatically. The detection and therapeutic device can be used independently or can be paired with daily goods, such as shoes and the like.

Abstract: The present invention provides a system, a method, devices and a computer implemented with a method for the monitoring and the control of a subject's organ perfusion. The present invention further provides for the use of a system, a method, devices and a computer implemented with a method for the monitoring and the control of a subject's organ perfusion.

Abstract: Some embodiments of a wearable infusion pump system can include a pump device having a drive system to dispense a medicine to a user, an activity sensor that detects a possible change in an activity level of the user, and a controller to activate the drive system to dispense the medicine to the user. The controller device can query the user to indicate whether a detected activity level of the user represents an actual change in the activity level of the user. The controller device can alter the medicine dispensing schedule based on the user indicated changes in activity level.

Abstract: A method for monitoring blood glucose concentration in a patient in need thereof is disclosed. The method comprises deploying an equilibrium glucose sensor within interstitial fluid in the patient in need and coupling the equilibrium glucose sensor to a monitor configured to detect a signal and configured to display the blood glucose concentration.

Abstract: A portable infusion pump can communicate with glucose monitor, such as a continuous glucose monitor (CGM), to receive continuous feedback relating to a user's blood glucose level during insulin or other medicament therapy and can automatically deliver insulin to a user when the CGM data indicates a need for additional insulin. Due to potential unreliability in the correlation of the CGM data to the user's actual blood glucose level, risk mitigation can be employed to limit the amount of extra insulin that can be delivered by the pump in response to the CGM data.