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: The medication delivery device is designed to receive a replaceable medication container and to determine an adjusted medication dose AD before each delivery of the medication contained in the medication container if the current content of the medication container is not a multiple of a prescribed dose D and is greater than the prescribed dose D. The adjusted medication dose AD is the dose to be delivered instead of the prescribed dose D during said medication delivery. The adjusted medication dose AD is determined by selecting one of a first dose, to that is higher than the prescribed dose D, and of a second dose, that is lower than the prescribed dose D, as a function of a variable B that cumulates the values (AD?D).

Abstract: Described herein are devices, systems, and methods for determining the composition of liquids, including the identity of one or more drugs in the liquid, the concentration of the drug, and the type of diluent using immittance spectroscopy. These devices, systems and methods are particularly useful for describing the identity and, in some variations, concentration of one or more components of a medical liquid such as intravenous fluid. In particular, described herein are devices, systems and methods that may operate in low ionic strength diluents. Also described are methods of recognizing complex immittance spectrograph patterns to determine the composition of a liquid by pattern recognition.

Abstract: This document discusses, among other things, an apparatus comprising a pump configured to deliver insulin, a processor, and a user interface including a bistable display. A display element of the bistable display is placed in one of two stable orientations upon application of a biasing voltage and stays in the stable orientation when the biasing voltage is removed. The processor includes a display module configured to display a non-blank reversion display screen on the bistable display when no input is received at the user interface after a specified time duration, and to recurrently change the reversion display screen until input is received at the user interface.

Abstract: An aspect of an embodiment or partial embodiment of the present invention (or combinations of various embodiments in whole or in part of the present invention) comprises, but not limited thereto, a method and system (and related computer program product) for continually assessing the risk of hypoglycemia for a patient and then determining what action to take based on that risk assessment. A further embodiment results in two outputs: (1) an attenuation factor to be applied to the insulin rate command sent to the pump (either via conventional therapy or via open or closed loop control) and/or (2) a red/yellow/green light hypoglycemia alarm providing to the patient an indication of the risk of hypoglycemia. The two outputs of the CPHS can be used in combination or individually.

Abstract: A method includes receiving measurements from a sensor associated with a patient at a portable medication delivery device. The method also includes controlling delivery of medication to the patient at the portable medication delivery device using a single input, single output (SISO) model predictive control technique. The SISO model predictive control technique includes predicting a characteristic of the patient using the measurements and a model associated with the patient. The SISO model predictive control technique also includes determining whether the characteristic of the patient is predicted to fall outside of a desired range. In addition, the SISO model predictive control technique includes, if the characteristic of the patient is predicted to fall outside of the desired range, determining an amount of medication to deliver to the patient and delivering the determined amount of medication to the patient.

Abstract: A therapy delivery system having an open architecture and method of providing thereof are disclosed. The present invention provides a therapy dosage module having a control algorithm that can be replaced with a predefined or independently defined control algorithm. The tools necessary to create and test such control algorithms in the therapy dosage module in a simulated environment before implementing it in a live therapy system are also disclosed.

Abstract: An implantable cardiac therapeutic device having at least one implantable sensor arranged to sense at least one physiologic characteristic of a patient, an implantable therapeutic agent delivery assembly wherein the delivery assembly and a therapeutic agent to be delivered are configured for placement in a patient's pericardial space, and a controller in communication with the at least one implantable sensor and with the therapeutic agent delivery assembly wherein the controller evaluates the at least one physiologic characteristic for indications of a condition indicating administration of the therapeutic agent and wherein, upon detection of such indications, induces the therapeutic agent delivery assembly to deliver the agent.

Abstract: The invention comprises an elongated device adapted for insertion, including self-insertion, through the body, especially the skull. The device has at least one effector or sensor and is configured to permit implantation of multiple functional components through a single entry site into the skull by directing the components at different angles. The device may be used to provide electrical, magnetic, and other stimulation therapy to a patient's brain. The lengths of the effectors, sensors, and other components may completely traverse skull thickness (at a diagonal angle) to barely protrude through to the brain's cortex. The components may directly contact the brain's cortex, but from there their signals can be directed to targets deeper within the brain. Effector lengths are directly proportional to their battery size and ability to store charge. Therefore, longer angled electrode effectors not limited by skull thickness permit longer-lasting batteries which expand treatment options.

Abstract: Activation of an enzyme in a bodily fluid is detected based on the amount of cleavage of a substrate for the enzyme. The substrate is tagged with two fluorescent dyes—a donor and an acceptor. The tagged substrate is presented to the bodily fluid. A device emits energy at a first wavelength into the bodily fluid, and detects energy at second and third wavelengths emitted by the dyes in response to the energy at the first wavelength. Prior to enzymatic cleavage of the substrate, the acceptor emits energy at the third wavelength in response to energy at the second wavelength received through fluorescent resonant energy transfer (FRET) from the donor. After enzymatic cleavage of the substrate, the donor emits energy at the second wavelength. The device can determine the concentration of activated enzyme within the bodily fluid based on the relative intensities of energy at the second and third wavelengths.

Abstract: A portable insulin injection pen and blood glucose monitoring device is integrated into a single unit for testing and treating diabetes symptoms. The device has a housing of a size suitable for transport in a user's clothing pocket or handbag. Within the housing is a blood glucose monitoring system for receiving a sample of the user's blood and detecting its glucose level, an insulin injection mechanism for administering an insulin injection, and a microprocessor that calculates an insulin dosage appropriate to the detected blood glucose level and sets the insulin injection mechanism to administer the calculated insulin dosage. A communication device automatically informs a remote emergency service provider, such as 911 or an emergency service to which the user has subscribed, if the microprocessor determines that the detected blood glucose level presents a potential danger to the user.

Abstract: An electronic device may be configured to prompt a user via an on-board display to measure user glucose via an on-board glucose meter, to compute a first drug bolus value based on the measured user glucose, to display the first drug bolus value on the display and prompt the user via the display to enter carbohydrate information into the device, to compute a second drug bolus value based on the entered carbohydrate information, to display the second drug bolus value on the display and prompt the user via the display to enter user health information into the device, to compute a third drug bolus value based on the entered health information and a total drug bolus value as a sum of the first, second and third drug bolus values, and to display the third and total drug bolus values on the display.

Abstract: A hand-held remote for a medical fluid injector includes a syringe and a conduit which may be coupled to a pressure transducer on a control circuit of the injector. Movement of a plunger within a syringe body on the syringe creates a pressure which is sensed by the pressure transducer and the control circuit responds to the sensed pressure by causing fluid to be ejected from, or drawn into, a syringe mounted to the injector. The pressure developed by the remote provides tactile feedback to an operator for improved control over injections.

Abstract: The present invention generally relates to systems and methods for monitoring and/or providing feedback for drugs or other pharmaceuticals taken by a subject. In one aspect, the present invention is directed to devices and methods for determining a species within the skin of a subject; and producing feedback to a subject based on the determination of the species. The feedback may be, for example, visual, audible, tactile, a change in temperature, etc. In some cases, information regarding the determination of the species may be transmitted to another entity, e.g., a health care provider, a computer, a relative, etc., which may then provide feedback to the subject in some fashion. In some cases, the feedback may be directly indicative of the species, e.g., whether the species is present, the concentration of the species, whether a by-product of a reaction involving the species is present, whether a compound affected by the species is present, etc. However, the feedback may also be indirect in some embodiments.

Abstract: A method and device for measuring and regulating pressure and flow in the spinal canal, in order to characterize individual patient's cerebrospinal fluid (CSF) dynamics. A unique disposable tube-set plate, with computer regulated automated solenoids is used to control flow pressure and the location of a small pressure sensor allows for fully automatic control of the analysis process.

Abstract: Various techniques for measuring cardiac cycle length and pressure metrics based on pulmonary artery pressures are described. One example method described includes identifying a point within a derivative signal of a cardiovascular pressure signal without reference to electrical activity of a heart, initiating a time window from the identified point in the derivative signal, identifying a point within the cardiovascular signal within the time window, and determining at least one of a systolic pressure or diastolic pressure based on the identified point.

Abstract: Various techniques for measuring cardiac cycle length and pressure metrics based on pulmonary artery pressures are described. One example method described includes identifying a point within a derivative signal of a cardiovascular pressure signal without reference to electrical activity of a heart, initiating a time window from the identified point in the derivative signal, identifying a point within the cardiovascular signal within the time window, and determining at least one of a systolic pressure or diastolic pressure based on the identified point.

Abstract: Drug delivery methods and systems that include a determination of whether a cardiac condition is normal or abnormal, so that a drug may be administered in accordance with that determination. In one implementation, a drug delivery device may be controlled to reduce or stop the drug administration when a normal cardiac condition is detected. In another implementation, a patient monitoring device determines the duration that a cardiac condition is normal and provides an output indicative of the determination so that the patient may alter a therapy accordingly.

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

Abstract: A device implantable into an eye of a patient for treatment of glaucoma. The device has an implantable dispenser. The dispenser includes an implantable reservoir configured to store a therapeutic agent. Additionally, the dispenser includes an implantable reservoir sensor configured to measure a pressure within the reservoir. The device also has an implantable processor coupled to the implantable reservoir sensor and configured to receive the measurement of the pressure within the reservoir and determine a dosage of therapeutic agent based on the measurement of the pressure within the reservoir. Furthermore, the implantable dispenser is configured to release the dosage of the therapeutic agent at a selectively variable rate from the implantable reservoir into the eye.

Abstract: An ambulatory medical device for detecting acceleration, temperature, and/or humidity conditions in or around the medical device is provided. The medical device includes one or more acceleration, thermal, and/or humidity sensors which detect acceleration, temperature, and/or humidity conditions in or around the medical device. In response to detected conditions, the medical device may, among other things, alter the operation of the device, provide an alarm or warning to the user, or transmit data about the detected conditions to another device.

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: In a pump infusion system comprising a pump adapted to be attached to a user and to cause infusion of pharmaceutical substances into the user's body, questions regarding the effects of administration of the pharmaceutical substances are provided, answers to said questions are transmitted to an attending staff, said answers are recorded, and said pump is controlled so as to adjust the dose of the pharmaceutical substances in accordance with said answers. Further, for a safe remote programming of such a pump infusion system, a predetermined program is assigned, a protocol to be programmed is compared with a protocol coming from the pump, possible errors of non-medically certified intervening devices and means are eliminated, and the programming is executed.

Abstract: A mechanism for optimizing insulin infusion rate of a CSII pump for each patient. A continuous subcutaneous insulin infusion therapy uses a continuous subcutaneous insulin pump, which includes: determining a circadian variation curve representing sympathetic nerve activity and that represents parasympathetic nerve activity of a target patient; acquiring an inflection point of each of the circadian variation curves representing the two types of nerve activity; detecting a time that corresponds to the inflection point; and employing the time as a point at which the insulin infusion rate of the continuous subcutaneous insulin infusion pump is changed.

Abstract: An infusion system that includes a controller device and a communication system to provide for two-way communication between the controller device and an infusion device that controls delivery of fluids to a user's body. Either the controller device or the infusion device may be integrated with a characteristic determining device in a single housing. The housing, in turn, may include a test-strip receptacle and an illuminator disposed so as to illuminate an area covering the receptacle and a test-strip inserted therein. The illuminator may be configured to be activated automatically when a test strip is inserted into the receptacle, selectively by the user via a button, key, or similar mechanism, and/or when the ambient light level, measured, e.g., with a light sensor, falls below a predetermined intensity. The illuminator may be a LED emitting white light, and may provide illumination at various levels of intensity.

Abstract: This system is characterized in that it includes means (2) for acquiring a signal representative of the electrocortical activity of the patient (1), means (3) for analyzing this signal in order to extract therefrom an anesthetic depth signal, means (4, 5, 6) for tracking the value and the time-dependent evolution of this anesthetic depth signal, associated with means (4, 5, 6) for computing control signals for controlling the injection means, in order to automatically bring the anesthetic depth signal to below a predetermined value during at least one predetermined period of time, in that the means for injecting anesthesia agents comprise first means (7) for injecting a hypnotic agent, and second means (8) for injecting a morphinomimetic agent, in that the means for computing control signals for controlling the injection means comprise means for inputting by an operator a type of anesthesia induction selected from a set of induction types which differ by the initial concentration of hypnotic agent and in that

Abstract: The system of the present invention includes an implantable device that can detect high and low frequency current signature. The implantable device can communicate with a communication device that includes a conductive element, an electronic component, and a partial power source in the form of dissimilar materials. Upon contact with a conducting fluid, the communication device is activated.

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: An injection device for injecting medication to a patient, comprising a surface (5) having a through hole (3) for passage of a needle, is characterised by further comprising a capacitive proximity sensor (12, 13, 30) for detecting proximity or contact of human skin to/with said surface (5).

Abstract: Certain embodiments disclosed herein include, but are not limited to, at least one of compositions, methods, devices, systems, kits, or products regarding rejuvenation or preservation of germ cells or gametes. Certain embodiments disclosed herein include, but are not limited to, methods of modifying germ cells or gametes, or methods of administering modified germ cells or gametes to at least one biological tissue.

Abstract: An infusion pump system is disclosed. The infusion pump system includes an infusion pump and a controller device in wireless communication with the infusion pump, wherein the controller including instructions for controlling the infusion pump, wherein the instructions may be synchronized with a secure web portal.

Abstract: Subject matter disclosed herein relates to monitoring and/or controlling blood glucose levels in patients. In particular, one or more substances may be delivered to a patient at a particular infusion rate while the patient's estimated glucose level is within a predetermined range. A different insulin infusion rate may then be applied if the patient's estimated blood glucose level deviates outside of the predetermined range.

Abstract: An outflow line is connected to an infusion pump that is programmed to run at a fixed rate. The outflow line has a bypass line that leads from the pump outlet back to the pump inlet. A line downstream of the entrance to the bypass line leads to the patient. The system has two valves. The fluid en route to the patient passes through the first valve. The bypass line passes through the second valve. When one valve is open, the other is closed. The valves' flow states are controlled by a signal from a control instrument. The system allows the pump output to be directed to the patient or to a bypass circuit that returns fluid leaving the pump back to the pump inlet. The system makes it possible to vary the amount of fluid delivered to a patient by an infusion pump set at a constant pumping rate by varying the open and closed state of valves in response to a signal from a patient monitoring instrument.

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: A method for monitoring and controlling biological substances found in the bloodstream include implanting in-vivo a pedestal such that a sensor mounted on the pedestal extends into the bone marrow for sensing the biological substance. A transmitter is included for transmitting signals from the sensor to a receiver. An apparatus that includes a monitoring device and a drug delivery device and components to communicate between the monitoring and drug delivery devices.

Abstract: An insulin pump and an infusion set adapter having a membrane which can be acted upon by a liquid flow path associated with the pump, wherein the pump comprises a sensor by which a change in shape or location of at least a portion of the membrane caused by a change in the liquid pressure in the flow path can be detected in a contact-free manner to identify an occlusion in the flow path.

Abstract: Apparatus, systems, and methods may operate to collect neuro data from an organ, such as a brain. Spikes may be detected using raw neuro data collected from the organ. The spikes may be sorted. Underlying neuronal firing rates may be estimated using the sorted spikes. The neuronal firing rates may be transmitted outside the organ for real time decoding.

Abstract: The present invention provides an indirect method and accompanying apparatus for supplying a high concentration of medicaments, particularly antibiotics, to the nasal sinuses by first loading the medicament into the cerebrospinal venous system (CVCS) via a Valsalva manuever. Because the CVCS is a valveless, three-dimensional closed system, traditional physiological dogma such as veins always draining tissues does not always apply. Instead, because in its closed-system blood can flow in any direction, the blood of the CVCS and any medicaments that it contains will be drawn to any portion of it where there is increased outflow, such as the copious venous-derived sinus fluid drainage present during nasal allergy or nasal infection. Thus, the very nasal congestion that impedes the effectiveness of direct medicament application, such as seen with nasal inhalers or systemic antibiotics, aids in applying the medicament indirectly to the nasal sinuses via the CVCS.

Abstract: The system for controlling body fluids overcomes the limitations of the prior art by automatically infusing diuretic and/or other drugs into a human patient. In one approach, the rate of infusion of the diuretic is adjusted based on the measured weight of the patient. For example, this weight can be transmitted wirelessly to a portable diuretic infusion device attached to the patient.

Abstract: Systems, devices, methods, and compositions are described for providing an actively controllable implant configured to, for example, monitor, treat, or prevent microbial growth or adherence to the implant.

Abstract: Methods and devices create an intestinal braking effect, are non-invasive or minimally invasive, and may be reversible. These methods and devices are accomplished via stabilized implantable systems and ingestible pills. In one embodiment, a method of producing satiety comprising the steps of accessing a gastrointestinal tract of a patient and implanting an intraintestinal therapeutic substance eluting implant. The implant is capable of eluting a satiety inducing substance selected from at least one of a nutrient, a specific satiety inducing bio-active substance, pancreatic polypeptides, free fatty acids, cholecystokinin, amino acids, glutamine, lipids, linoleic acid, or a combination thereof, from the implant into the gastrointestinal tract.

Abstract: A micromechanical pumping system is formed on a substrate surface. The pumping system uses a pumping element which pumps a fluid through valves which move in a plane substantially parallel to the substrate surface. An electromagnetic actuating mechanism may also be fabricated on the surface of the substrate. Magnetic flux produced by a coil around a permeable core may be coupled to a permeable member affixed to a pumping element. The permeable member and pumping element may be configured to move in a plane parallel to the substrate. The electromagnetic actuating mechanism gives the pumping system a large throw and substantial force, such that the fluid pumped by the pumping system may be pumped through a transdermal cannula to deliver a therapeutic substance to the tissue underlying the skin of a patient.

Abstract: A system comprising means for obtaining a signal representative of the electrocortical activity of the patient, means for analyzing this signal in order to derive from it a signal of depth of anaesthesia, means for monitoring the value and development over time of this signal of depth of anaesthesia, these means being associated with means for calculation of control commands of the injection means, in order to regulate automatically in closed loop the signal of depth of anaesthesia in a predetermined range around a target value, and in that the means for injection of anaesthetics comprise first means for injection of a hypnotic that receive control commands at a first frequency, and second means for injection of a morphinomimetic that receive control commands at a second frequency higher than the first frequency.

Abstract: A system and method to automatically initiate an injection procedure of a medicament into a patient. In the system, a delivery assembly includes an injector for infusing the medicament into the patient. Further, the system includes a monitor for detecting a parameter characteristic of the procedure, for instance, a pressure indicative of a partial vacuum between the injector and the injection site, a pressure exerted by the patient against the delivery assembly, a conductance, a capacitance, or an optical blood reading. Also, the system includes a timer for determining compliance of the parameter within a predetermined range during a first time interval. In response to the timer, an actuator initiates the injection procedure at the expiration of the first time interval. Further, the actuator may stop the injection procedure if the parameter is outside the predetermined range during a second time interval.

Abstract: Certain embodiments disclosed relate to compositions, including therapeutic compositions, methods, articles of manufacture, systems, and devices. Certain embodiments relate to anti-viral compositions, methods, articles of manufacture, systems and devices.

Abstract: During diastolic coronary perfusion, blood perfuses through the heart via the coronary arteries. Delivery of a therapeutic and/or diagnostic agent to the heart during diastolic coronary perfusion allows the therapeutic and/or diagnostic agent to efficiently perfuse through the heart. A medical device according to the invention detects closure of the aortic valve of a heart, and initiates delivery of a therapeutic and/or diagnostic agent upon detection of aortic valve closure. The medical device detects aortic valve closure by processing a signal.

Abstract: Methods, systems, and software for controlling infusion pressure, such as during a medical procedure, using systemic blood pressure are described. Systemic blood pressure, such as brachial arm blood pressure or radial artery blood pressure, may be used to estimate central retinal artery blood pressure to estimate critical closing pressure. Further, the disclosure relates to controlling infusion pressure to prevent an increase in intraocular pressure above the estimated critical closing pressure when such is not desired, and, when such is desired, using systemic blood pressure and infusion pressure to control an intentional increase in intraocular pressure above the estimated critical closing pressure to stop intraocular bleeding.

Abstract: A closed-loop system for insulin infusion overnight uses a model predictive control algorithm (“MPC”). Used with the MPC is a glucose measurement error model which was derived from actual glucose sensor error data. That sensor error data included both a sensor artifacts component, including dropouts, and a persistent error component, including calibration error, all of which was obtained experimentally from living subjects. The MPC algorithm advised on insulin infusion every fifteen minutes. Sensor glucose input to the MPC was obtained by combining model-calculated, noise-free interstitial glucose with experimentally-derived transient and persistent sensor artifacts associated with the FreeStyle Navigator® Continuous Glucose Monitor System (“FSN”).

Abstract: The invention relates to a device comprising an ingestible capsule which measures at least one body parameter and starts a drug release program upon predefined changes in the body parameter.

Abstract: In accordance with the invention apparatus is provided for monitoring the activity of a surgeon. The apparatus comprises a plurality of wireless sensing units for producing an output indicative of nerve stimulation. A receiver takes the output of the receiver units and produces at its output a plurality of signals each corresponding to the output of one of the plurality of wireless sensing units. An analyzer unit receives the plurality of signals each corresponding to the output of one of the plurality of wireless sensing units from the receiver. An indicator responds to the output of the analyzer unit.