Abstract: System and methods are provided for harvesting one or more organs, e.g., a lung from a donor body. In one embodiment, a distal end of a tubular member is introduced into the donor body's vasculature via a percutaneous access site, and the tubular member is manipulated until the distal end of the tubular member is disposed within the thoracic duct. Fluid is removed from the thoracic duct through the tubular member to a location exterior to the patient's body, and one or more organs are removed from the donor body. Optionally, one or more parameters within the thoracic duct or other parameters of the donor body may be monitored and fluid removal may be adjusted to reduce fluid accumulation within the one or more organs.

Abstract: An apparatus and method for detecting an occlusion in a downstream fluid line of a medical pump in relation to increased pressure in the downstream fluid line between the beginning and the end of each interval of a series of intervals of operation of the pump even if one or more intervals between the first and last intervals does not reflect such an increase in pressure in the downstream fluid line.

Abstract: Cerebral Catheter devices and methods for use are provided. The catheter devices provided may include an anti-thrombotic agent coating on the exterior surface. The catheter devices may include unique tip configurations to allow improved fluid delivery capabilities. Further, the catheter devices may also or alternatively include one or more sensor devices in communication with a controller that allow automatically adjusting the delivery of a therapeutic fluid, for example a vasodilator, in response to the condition sensed by the catheter device, such as increased pressure. Moreover, the catheter devices may also be used in conjunction with blood flow transducers to detect and timely prevent and treatment vasospasms or other conditions. Methods for preventing and treatment vasospasm, neoplasm, or other pathological conditions while prolonged using the catheter device are also provided.

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: Systems and methods for integrating a continuous glucose sensor, including a receiver, a medicament delivery device, and optionally a single point glucose monitor are provided. Manual integrations provide for a physical association between the devices wherein a user (for example, patient or doctor) manually selects the amount, type, and/or time of delivery. Semi-automated integration of the devices includes integrations wherein an operable connection between the integrated components aids the user (for example, patient or doctor) in selecting, inputting, calculating, or validating the amount, type, or time of medicament delivery of glucose values, for example, by transmitting data to another component and thereby reducing the amount of user input required. Automated integration between the devices includes integrations wherein an operable connection between the integrated components provides for full control of the system without required user interaction.

Abstract: Systems, devices, methods, and compositions are disclosed which include an actively-controllable implantable device configured to, for example, capture and/or release biochemical and/or biological cells in a subject.

Abstract: There is provided a method of reducing or preventing catheter reflux during infusion of a therapeutic agent into a brain of a subject comprising administering the therapeutic agent to a target area of the brain by intermittent infusion at a predetermined interval. There is provided a method of treating a CNS disorder comprising administering a therapeutic agent to a target area of a brain of a subject by intermittent infusion at a predetermined interval. There is also provided a system for reducing or preventing catheter reflux during infusion of a therapeutic agent into a target area of a brain of a subject comprising an infusion device, at least one chronically implanted intracranial catheter, a monitoring device configured to monitor the target area of the brain after each infusion, and a determination unit configured to determine whether a predetermined interval is acceptable.

Abstract: Disclosed is a patient monitoring and drug delivery system and associated methods for use during diagnostic, surgical or other medical procedures. The functionality of the invention enables many time consuming and laborious activities to be minimized or moved to a part in the procedure where time is not as critical. The invention is capable of increasing practice efficiency in patient care facilities through system architecture and design into two separate units. A patient unit receives input signals from patient monitoring connections and outputs the signals to a procedure unit. The procedure unit is operational during the medical procedure and controls the delivery of drugs to the patient.

Abstract: The present invention relates to a quantitative electroencephalogram (QEEG) monitor and system capable of monitoring and displaying simultaneously neuropathological characteristic and activity of both sides of a subject's brain. The methods include various indices and examination of differences in these indices by which neurophysiological conditions or problems can be identified and treated. These methods, and the systems and devices using these methods preferably can be used for identifying these neurophysiological conditions or brain dysfunction with monitors and methods for seizure detection, for sedation monitoring, for anesthesia monitoring, and the like. These bilateral brain monitoring methods and systems, and the devices using these methods can be used by individuals or clinicians with little or no training in signal analysis or processing. These bilateral monitoring methods can also be used in a range of applications.

Abstract: According to the present invention, a method for enhancing transdermal transport is disclosed. The method includes the steps of increasing a permeability an area of a membrane with a permeabilizing device. The membrane may be, inter alia, biologic skin or synthetic skin. The permeabilizing device may be an ultrasound-producing device. A substance is transported into and through the area the membrane. The substance may be a drug, a vaccine, or a component of interstitial fluid.

Abstract: An administration device for the administration of a liquid drug in adjustable doses may comprise an injection unit and an electronic indication unit. The injection unit may comprise a dosing mechanism and a manually operated dose setting component. The manually operated dose setting component may adjust the dosing mechanism to administer an administration dose amount of the liquid drug. The electronic indication unit may indicate a relationship between the administration dose amount and a target dose amount. A method for setting a dose of a liquid drug for administration may comprise providing an administration device, operating a manually operated dose setting component of the administration device, and continuing to operate the dose setting component until an electronic indication unit indicates that the administration dose amount is equal to the target dose amount.

Abstract: Apparatus and method detect a detection cluster that is associated with a neurological event, such as a seizure, of a nervous system disorder and update therapy parameters that are associated with a treatment therapy. The occurrence of the detection cluster is detected when the maximal ratio exceeds an intensity threshold. If the maximal ratio drops below the intensity threshold for a time interval that is less than a time threshold and subsequently rises above the intensity threshold, the subsequent time duration is considered as being associated with the detection cluster rather than being associated with a different detection cluster. Consequently, treatment of the nervous system disorder during the corresponding time period is in accordance with one detection cluster. Treatment therapy may be provided by providing electrical stimulation, drug infusion or a combination.

Abstract: Disclosed is a medical device to treat diabetes. The medical device includes a bolus calculator to determine an insulin bolus based on, at least in part, a glycemic index value associated with an intake to be consumed by a user, the bolus calculator further adapted to determine the insulin bolus using one or more inputs selected from the group consisting of a carbohydrate load of the intake, a current glucose level of the user, a residual insulin of the user, a carbohydrate to insulin ration, an insulin sensitivity of the user and a target glucose level of the user. The bolus calculator is housed in one or more of, for example, an insulin dispensing pump, a handheld remote control unit for the insulin dispensing pump and/or a handheld glucose monitor.

Abstract: We disclose methods and medical device systems for automated delivery of therapies for pain and determination of need for and safety of treatment. In one embodiment, such a medical device system may comprise a sensor configured to sense at least one body signal from a patient; and a medical device configured to receive a first sensed body signal from the sensor; determine a patient pain index based at least in part on said first sensed body signal; determine whether said patient pain index is above at least a first pain index threshold; determine a safety index based at least in part on a second sensed body signal; select a pain treatment regimen based on at least one of said safety index and or a determination that said pain index is above said first pain index threshold; and deliver said pain treatment regimen.

Abstract: We report a method of treating an epileptic seizure in a patient, comprising: detecting said epileptic seizure, based on body data from said patient; and reducing a flow of blood to a brain of said patient in response to said detected seizure; wherein said reducing is effected by at least one of: applying a pressure, applying a cooling, or administering a vasoconstrictive agent to a vessel supplying blood to at least a portion of the brain. We also report a medical device system configured to implement the method. We also report a non-transitory computer readable program storage unit encoded with instructions that, when executed by a computer, perform the method.

Abstract: This invention is a device and method for selectively and automatically reducing absorption of unhealthy food in a person's gastrointestinal tract, while allowing normal absorption of healthy food. In an example, such a device can comprise: a food-identifying sensor; an absorption-reducing substance; an implanted reservoir; and a release-control mechanism that selectively and automatically releases the substance into the person's gastrointestinal tract when the sensor detects that the person is consuming unhealthy food.

Abstract: The subject matter described herein relates to controlling and automating a delivery of one or boluses of a fluid medication to a patient. A user interface can display lists of parameters, such as a list of types of fluid in the fluid medication, a list of modes for delivery of the one or more boluses, a list of flow rates of each bolus delivery, a list of durations corresponding to each bolus, a list of initiation times of each bolus, and a list of initiation events for each bolus. In response, a clinician can select and/or specify parameters for the one or more boluses. Subsequently, the infusion device can deliver the one or more boluses based on the selected or specified parameters. Related apparatus, systems, techniques and articles are also described.

Abstract: Embodiments are directed to infusion devices, systems, and methods to detect a capacity of a collapsible fluid reservoir of an infusion cartridge and/or a volume of a fluid disposed in the collapsible fluid reservoir or some other parameters of the infusion cartridge, and setting corresponding therapeutic parameters of an infusion device. Embodiments may include, obtaining data on the volume of fluid in the collapsible fluid reservoir, analyzing the obtained data to determine the setting of therapeutic parameters, and setting one or more therapeutic parameters of an infusion device.

Abstract: A system for diagnosing and/or treating a patient comprising a patient information database for storing and retrieving patient health data related to the patient. The data includes one or more of real-time patient health information, at least one clinical practice guideline, at least one patient questionnaire and a patient medical history. At least one server is operative to access the patient information database. A computing device remotely located from the server, including a microprocessor, configured to store a computer application and is configured for communication with the server for retrieving of the patient health data. The computer application generates at least one of a patient diagnosis or a patient treatment recommendation using the retrieved patient health data.

Abstract: In various embodiments of the invention, a vacuum pump can be used as a stand alone unit to create, monitor and control a vacuum in a variety of surgical procedures. The vacuum pump can be controlled by a processor and automatically increases or decreases the vacuum based on monitoring of parameters selected from the group consisting of heart-rate of the fetus, heart rate of the mother, heart rate of patient, blood pressure of the fetus, blood pressure of the mother and blood pressure of the patient, position of the wound, position of the fetus, condition of the fetus, condition of the mother, condition of the patient. Visual or audio feedback is used to allow the care giver increased control of the pumping device while carrying out the procedure.

Abstract: We report a method of treating an epileptic seizure in a patient, comprising: detecting said epileptic seizure, based on body data from said patient; and reducing a flow of blood to a brain of said patient in response to said detected seizure; wherein said reducing is effected by: increasing the parasympathetic input to said patient's heart, such as by electrically stimulating a parasympathetic nervous structure, applying cooling energy to a sympathetic nervous structure, or administering a cholinergic or a sympatho-blocking agent to said patient. We also report a medical device system configured to implement the method. We also report a non-transitory computer readable program storage unit encoded with instructions that, when executed by a computer, perform the method.

Abstract: Systems and methods for intelligently delivering fluid to a targeted tissue. The systems and methods may include directing a pump to distribute fluid to a targeted tissue and receiving one or more signals from an intracorporeal sensing system, where the one or more signals correspond to one or more sensed feedback parameters at the targeted tissue. The systems and methods may also include determining whether the one or more sensed feedback parameters are within an acceptable range. If the one or more sensed feedback parameters are not within the acceptable range, the systems and methods may include determining an adjusted velocity for the plunger necessary to adjust the pressure of the fluid in the pump so that the one or more sensed feedback parameters move within the acceptable range and directing the pump to distribute the fluid at the adjusted velocity.

Abstract: Provided is a method for treating or preventing peritonitis by administering a therapeutically effective amount of an oxidative reduction potential (ORP) water solution that is stable for at least about twenty-four hours. The ORP water solution administered in accordance with the invention can be combined with one or more suitable carriers and can be administered in conjunction with one or more additional therapeutic agents. Further provided is a method for preventing peritoneal hemorrhage, adhesions and abscesses.

Abstract: A device for dispensing medication to the ear with a tympanic membrane sensor and medication dispenser which dispenses medication upon identification of the tympanic membrane by the sensor is provided. Also provided are methods for using the device to dispense medications to the ear.

Abstract: Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Many embodiments provide a swallowable device for delivering the agents. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade within the wall to release the drug to produce a therapeutic effect. The preparation can be coupled to an actuator having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the intestinal wall. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

Abstract: A method for delivering a target volume of fluid to a destination is provided. The method includes delivering a first volume of fluid to the destination in increments each having approximately a first incremental volume, the first volume of fluid being less than the target volume and delivering a second volume of fluid to the destination in increments each having approximately a second incremental volume, the second incremental volume being less than the first incremental volume, such that the sum of the first volume and the second volume is approximately equal to the target volume.

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

Abstract: The invention provides methods for diagnosing and treating deep vein thrombosis and other conditions associated with occluded or constricted vessels. According to certain aspects, methods of the invention involve inserting a sensing device into a vessel having a thrombus therein, assessing, with the sensing device, one or more functional parameters within the vessel, determining an interventional therapy for treating the thrombus based on the assessing step; and performing the interventional therapy.

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

Abstract: Systems for delivery of therapeutic agents and related methods are disclosed. A sensing system is configured to detect a chemical in the vicinity of a patient and transmit a signal to a controller upon detection. A controller is configured to release a therapeutic agent which is transported to the site of interest. The controller communicates with an electronic medical records database, an alarm and a nurse call system.

Abstract: Systems, apparatuses, and methods for delivery of an active agent in response to the changes in electrical activity of a subject's lower esophageal sphincter. Changes in electrical activity can be monitored by a monitoring unit containing a microprocessor. A reservoir and pump can be used to store and release the active agent. The active agent can be cholecystokinin, peptide YY, glucagon-like peptide 1 or 2, and ghrelin, or a combination thereof.

Abstract: Detection of fluid conditions in an administration set. A light source is positioned to transmit an infrared light through administration set tubing and any fluid therein. A light sensor senses the infrared light transmitted through the tubing and generates an output signal. A frequency of the output signal is a function of an intensity of the light transmitted through the tubing. A processor receives and determines the frequency of the output signal, and compares the determined frequency to threshold frequency values to determine whether fluid is in the tubing. The processor also monitors the generated output signal to determine if the frequency of the output signal changes over time, and determines whether fluid is flowing in the tubing as a function of the determined change in frequency.

Abstract: Methods, system and devices for monitoring a closed loop control operation including signal levels received from an analyte sensor and automatic delivery of medication at least in part in response to the received analyte sensor signals, determining whether the signal level received from the analyte sensor is associated with one of a fault condition or a potential fault condition, and dynamically adjusting a current infusion rate executed by the closed loop control operation when it is determined that the signal level from the analyte sensor is associated with one of the fault condition or potential fault condition, where 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 a potential fault condition, and where the first predetermined range is narrower compared to the second predetermined range are provided.

Abstract: The present invention relates to a device, system and a method for optimizing syringe based drug delivery profile with a treatment element and in particular, to such a device, system and method in which optimization is based on a plurality of data that directly and/or indirectly affect the optimization of the drug delivery profile. The device facilitating syringe based drug delivery, by optimizing drug delivery of the injected drug, records user's activity, and data relative to drug injections, comprising a disposable unit configured for a single use period and a rechargeable reusable unit having electronics comprising a sensor module.

Abstract: Optimized bio-synchronous drug delivery begins with establishing a bio-synchronous treatment protocol that incorporates individual temporal and innate biological characteristics into a pharmacological treatment plan. The bio-synchronous treatment protocol is thereafter initiated using bioactive agent delivery device. Bio-synchronous drug delivery includes continual collection of patient data such as physical, psychological, temporal and environmental characteristics. This data is analyzed so to not only determine an initial treatment protocol but to also determining whether modification to the ongoing bio-synchronous treatment protocol is required. And, responsive to determining a modification is required the system modifies the bio-synchronous treatment protocol and use of delivery device. These modifications and treatment protocols can include reactive and proactive psychological support supplied to the patient in a variety of formats.

Abstract: The present invention relates to a method for determining start timing of supply of drug to be given in which a peripheral circulatory function and an autonomic nervous function are activated through a stimulus applied to a stimulus application origin part of a body surface by an acupuncture needle or warm heating etc., and a drug conveyance system according to the method for determining start timing of supply of drug.

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: One embodiment enables detection of MI/I and emerging infarction in an implantable system. A plurality of devices may be used to gather and interpret data from within the heart, from the heart surface, and/or from the thoracic cavity. The apparatus may further alert the patient and/or communicate the condition to an external device or medical caregiver. Additionally, the implanted apparatus may initiate therapy of MI/I and emerging infarction.

Abstract: Bypass elements for medical valves and methods of using the same are disclosed. Embodiments of the invention include an insert having a tip that is adapted to displace a valve element without penetrating it, and a lumen that fluidly communicates with a lumen of a valve housing distal to the valve element when the bypass element is engaged. Bypass elements are used, in certain embodiments, to facilitate fluid pressure and ECG signal measurements through implanted medical devices including catheters.

Abstract: Devices, systems, or methods are disclosed herein for treatment of disease in a vertebrate subject. The device can include a quasi-planar substrate; and one or more laterally-mobile effector molecule types at least partially embedded within the quasi-planar substrate, wherein the one or more laterally-mobile effector molecule types is configured to interact with one or more cell types. The device can further include one or more sensors configured to detect at least one aspect of an interaction between the at least one of the one or more laterally-mobile effector molecule types and the one or more cell types; and a controller in communication with the one or more sensors, wherein the controller is configured to responsively initiate modification of at least one of the one or more laterally-mobile effector molecule types, the quasi-planar substrate, and the one or more cell types.

Abstract: A drug delivery device which includes a fluid drug reservoir, a catheter, a controllable fluid transfer device, e.g., a pump mechanism or valve, and a drug delivery control means. The drug delivery control means comprises a controller, e.g., a microprocessor or microcontroller which is operable to automatically reduce the rate of drug delivery over a certain reduction interval (e.g., multiple days) from an initial dosage value to a final dosage value.

Abstract: A method for injecting a substance through a biological body surface includes providing a needle-free transdermal transport device configured to inject the substance through the surface. The substance is injected into the biological body with the transport device while a parameter of the injection is sensed and a servo-controller is used to dynamically adjust at least one injection characteristic based on the sensed parameter. The substance is injected for (i) a first time period during which a first portion of a volume of the substance is injected at a first injection pressure, and (ii) a second time period during which a remainder of the volume of the substance is injected at a second injection pressure. A viscosity of the substance may be determined, and a pressure calculated for injecting the substance based on the viscosity. The substance may be injected with the transport device by using the calculated pressure.

Abstract: A system, method and apparatus for real time measurement and monitoring of various personal health parameters including controlled delivery of drugs/medications by intelligent pump appliances, intelligent inhalation appliances and intelligent skin patch appliances used in a standalone manner or in a wired or wireless networked configuration, in conjunction with various peripheral devices, other intelligent appliances, servers, RF ID Tags and stationary/mobile devices. The intelligent appliances relate to the measurement, monitoring and delivery of insulin/other drugs for the treatment of diabetes and other diseases. The method also additionally includes the application of intelligent appliances for pain management including visualization of organs and body locations exhibiting pain.

Abstract: A method for providing decision-assist to medical staff resuscitating a burn patient includes receiving patient information, calculating an infusion rate, outputting the infusion rate, obtaining a urinary output, calculating a new infusion rate using infusion rate model based constants, and outputting the new infusion rate. In some embodiments, the method includes notifying medical staff when problems arise, displaying information regarding the resuscitation, and setting limits regarding the infusion rates.

Abstract: A system is provided for testing whether an iontophoretic drug delivery device is in an appropriate state for administering a therapeutic agent into an animal body. An electrical characteristic of at least one electrical path associated with an electrode test point is used to determine whether the iontophoretic device is in an appropriate state. The measured electrical characteristic indicates that the iontophoretic device is in an appropriate state for administering the therapeutic agent into the animal body when the therapeutic agent is properly disposed with respect to the electrodes of the iontophoretic device.

Abstract: Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Some embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. The device comprises a capsule sized to be swallowed and pass through the intestinal tract. The capsule can include at least one guide tube, one or more tissue penetrating members positioned in the guide tube, a delivery member, an actuating mechanism and a release element. The release element degrades upon exposure to various conditions in the intestine so as to release and actuate the actuating mechanism. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

Abstract: One variation of a method for setting a blood transfusion parameter for a patient includes identifying a blood transfusion bag in a photographic image; extracting a color feature from a region of the photographic image corresponding to the blood transfusion bag; estimating a blood component content within the blood transfusion bag based on the color feature; and triggering transfusion from the blood transfusion bag based on the blood component content within the blood transfusion bag and an estimated volemic status of the patient.

Abstract: Methods and apparatus, including computer program products, are provided for processing analyte data. In some example implementations, a method may include generating glucose sensor data indicative of a host's glucose concentration using a glucose sensor; calculating a glycemic variability index (GVI) value based on the glucose sensor data; and providing output to a user responsive to the calculated glycemic variability index value. The GVI may be a ratio of a length of a line representative of the sensor data and an ideal length of the line. Related systems, methods, and articles of manufacture are also disclosed.

Abstract: A system, method and apparatus for real time measurement and monitoring of various personal health parameters including controlled delivery of drugs/medications by intelligent pump appliances, intelligent inhalation appliances and intelligent skin patch appliances used in a standalone manner or in a wired or wireless networked configuration, in conjunction with various peripheral devices, other intelligent appliances, servers, RF ID Tags and stationary/mobile devices. The intelligent appliances relate to the measurement, monitoring and delivery of insulin/other drugs for the treatment of diabetes and other diseases. The method also additionally includes the application of intelligent appliances for pain management including visualization of organs and body locations exhibiting pain.

Abstract: Methods and kits for delivering pharmaceutical agents to the adventitia and other regions outside the external elastic lamina (EEL) surrounding a blood vessel utilize a catheter having a needle. The needle is positioned in up to 5 mm beyond the EEL and delivers an amount of pharmaceutical agent sufficient to circumferentially permeate around the blood vessel and, in many cases, extend longitudinally and radially along the blood vessel. Confirmation that a delivery aperture of the needle lies beyond the EEL may be required before delivering the pharmaceutical agent.