Abstract: Disclosed is a mask-free system and method for inducing anesthesia in a pediatric patient. In a preferred embodiment, calming and then anesthetic gases are administered through a mouthpiece with a distraction device, such as an inflatable bag or balloon or an audible siren whistle. This system avoids the anxieties and trauma of the pediatric patient and their parents that have been associated with mask-based induction methods.

Abstract: Condensation or “rain-out” is a problem in breathing circuits and especially neonatal breathing circuits. The subject patent provides an improved breathing tube component for managing rain-out particularly in neonatal applications. In particular the breathing tube has a smooth inner bore, and an outer insulating layer containing stagnant gas and a heater wire.

Abstract: A ventilator with an integrated cough assist for use with a patient circuit in fluid communication with a patient connection of a patient, and operable in a ventilation mode and in a cough-assist mode. The ventilator includes a user input for switching operation from ventilation mode to cough-assist mode without disconnecting the ventilator from the patient, and a controller operable in response to the user input and controlling operation of the ventilator in cough-assist mode to provide for at least one cough assist to the patient having an insufflation phase followed by an exsufflation phase. A cough-assist valve in a first state for the insufflation phase communicates a positive pressure to the ventilator connection and in a second state for the exsufflation phase communicates a negative pressure to the ventilator connection.

Abstract: A system and method for controlling a flow is disclosed. The system includes an inlet channel (100, 310) and an outlet channel (200, 320). The inlet channel has an inlet port at a first end configured to be connected to a patient, and a second end with an at least part-annularly shaped aperture (314). The outlet channel has an outlet port at a first end, and an aperture (313) at a second end. The system further comprises a flow channel arranged concentrically outside the at least part-annularly shaped aperture. The flow channel is in fluid connection with the outlet channel. The at least part-annularly shaped aperture of the inlet channel and the aperture of the outlet channel are separated by a seating means (312). The at least part-annularly shaped aperture of the inlet channel and the flow channel are separated by the seating means.

Abstract: An active exhalation valve for use with a ventilator to control flow of patient exhaled gases. The valve includes a patient circuit connection port, a patient connection port, an exhaled gas port, a pilot pressure port, and a valve seat. The valve further has a movable poppet with inner and outer bellows members and a bellows poppet face. An activation pressure applied to the pilot pressure port extends the bellows members to move the poppet face into engagement with the valve seat and restrict flow of patient exhaled gases to the exhaled gas port, and the reduction of the activation pressure allows the bellows members to move the poppet face away from the valve seat and out of engagement with the valve seat to permit flow of patient exhaled gases to the exhaled gas port, thereby controlling the flow of patient exhaled gases from the valve.

Abstract: A passive valve for use as a fixed leak valve. The valve includes a body having an internal chamber, first and second body ports in fluid communication with the chamber with the first port configured for fluid communication with a patient connection and the second body port configured for fluid communication with a ventilator, a body passageway in fluid communication with the chamber and with ambient air exterior of the body, and a check valve seal positioned to seal the body passageway to permit the flow of gas within the chamber through the body passageway to the exterior of the body and to prevent the flow of ambient air exterior of the body through the body passageway into the chamber. In alternative embodiments, the valve is incorporated into the patient connection or constructed as a separate part connectable to the patient connection.

Abstract: Described herein are methods and devices for selectively applying fluids (particularly anesthetics) to a target tissue from within a blood vessel while minimizing the amount of fluid applied to non-target tissue. The injection catheters described herein may include an elongate body, a directional injector, and one or more holdfasts for securing the catheter before extending the injector. The methods of selectively applying anesthetic to a target structure generally include the steps of inserting an injection catheter into a body vessel, positioning the injection catheter within the body vessel near the target structure, anchoring the injection catheter before extending a directional injector from the injection catheter, and applying anesthetic from the injection catheter to the target structure.

Abstract: The invention discloses methods and systems for modulation of the central nervous system and more particularly for modulation of brain oscillatory activity and the brain networks that give rise to it. The methods involve using one or more non-invasive stimuli, either alone or in combination, to increase, decrease, or otherwise modulate neural oscillations, the rhythmic and/or repetitive electrical activity generated spontaneously and in response to stimuli by neural tissue in the central nervous system. Various embodiments concern methods and devices for detecting sub-optimal or pathological neural oscillatory patterns, developing treatment protocols to modify the neural oscillations in a desired manner, introducing a non-invasive stimulus or stimuli through one or more sensory pathways to treat the conditions, and for adjusting the treatment protocol to optimize the therapeutic effect of the stimulus or stimuli.

Abstract: A lamp turns on a bright light when a sleeper's pulse races during a night terror. The night terror lamp communicates wirelessly with a heart-rate monitor worn by the sleeper. The bright light helps to wake the sleeper and helps to alert others that the sleeper is having a night terror so they can help the sleeper. Other devices and methods are disclosed.

Abstract: In an example embodiment of the disclosed technology, a system can comprise a pain stimulator such as a thermal probe and a device for evaluating biological and/or neurological feedback that can provide data relating to a patient's physiological and/or neurological state. Embodiments of the disclosed technology may further comprise a computing device for implementing various aspects of the technology. Aspects of the disclosed technology can be used to reduce a patient's pain-related anxiety, thus reducing a patient's pain sensitization and pain perception, which can help a patient eliminate or lessen chronic pain symptoms.

Abstract: A catheter has excellent torque transmissivity and excellent flexibility, thus enabling easy insertion of the catheter into a blocked portion of a blood vessel. Additionally, the catheter easily restores to its original form even when the catheter is curved and deformed a large amount. Thus, a break at a border area between a catheter main body part and a distal end tip is prevented when the catheter is bent and deformed. This improves the operability of the catheter with a combination device such as a guide wire. The catheter includes a hollow coil body formed of at least one helically wound stranded wire. The at least stranded wire includes a plurality of wires wound into a helical structure.

Abstract: Methods and apparatus are provided for treatment of heart arrhythmia via renal neuromodulation. Such neuromodulation may effectuate irreversible electroporation or electrofusion, ablation, necrosis and/or inducement of apoptosis, alteration of gene expression, action potential attenuation or blockade, changes in cytokine up-regulation and other conditions in target neural fibers. In some embodiments, such neuromodulation is achieved through application of an electric field. In some embodiments, such neuromodulation is achieved through application of neuromodulatory agents, of thermal energy and/or of high intensity focused ultrasound. In some embodiments, such neuromodulation is performed in a bilateral fashion.

Abstract: A balloon catheter includes a balloon and an inner shaft. The inner shaft includes a marker member arranged on an outer periphery of a coil body having a sparsely wound portion in which gaps are formed between adjacent windings of the wire of the coil body. A distal end part and a proximal end part of the marker member are arranged at a position facing a void formed within one of the gaps between the adjacent windings of the wire of the coil body. The inner shaft of the balloon catheter therefore will not buckle, preventing damage to the balloon by contact with the marker member when the balloon catheter is passed through the inside of a curved blood vessel.

Abstract: An introducer (10) with a steerable distal tip section (17) is disclosed. The steerable distal tip section may comprise an articulation support member comprising a laser-cut pattern of symmetrical elongated apertures in which the shape of each aperture is defined by at least three radii, a central radii being the largest and two end radii being smaller. This pattern of apertures can minimize ovaling of the cross-sectional shape of introducer shaft over the length of the deflectable section. The introducer can articulate in multiple planes. A tension pull wire can allow the introducer to resist directional bias.

Abstract: A system for deploying an implantable medical device into a body lumen is disclosed. The system comprises a catheter having functional zones for stability, protection, flexibility, trackability and pushability. The system further comprises a device for deploying an implantable medical device with the catheter. A method for deploying an implantable medical device into a body lumen using the system is also disclosed.

Abstract: Articulation devices, systems, methods for articulation, and methods for fabricating articulation structures will often include simple balloon arrays, with inflation of the balloons interacting with elongate skeletal support structures so as to locally alter articulation of the skeleton. The balloons can be mounted to a substrate of the array, with the substrate having channels that can direct inflation fluid to a subset of the balloons. The articulation array structure may be formed using simple planar 3-D printing, extrusion, and/or laser micromachining techniques. The skeleton may comprise a simple helical coil or interlocking helical channels, and the array can be used to locally deflect or elongate an axis of the coil under control of a processor. Liquid inflation fluid may be directed to the balloons from an inflation fluid canister, and may vaporize within the channels or balloons of the articulation system, with the inflation system preferably including valves controlled by the processor.

Abstract: Some embodiments of an anchor device may include bendable anchor mechanism that is deployable in a subcutaneous layer to releasably secure the anchor device to a patient's body. Certain embodiments of the anchor mechanism may include one or more barbs that flexibly bend in response to an insertion or removal force. As such, the anchor mechanism may be inserted into a subcutaneous layer, and removed from the subcutaneous layer, without the need for a separate actuation device to extend or retract the barbs.

Abstract: Some embodiments of a medical device anchor system include an anchor device that secures a medical instrument (such as a catheter or the like) in place relative to a skin penetration point using subcutaneous anchors. In some implementations, the medical instrument can be coupled to the anchor device using a snap-lock cap mechanism.

Abstract: A bi-metal medical guidewire with a core wire having a stainless steel proximal section and Nitinol distal section offers performance enhancements compared to guidewires made from either alloy alone. A solid-state, frictional welding or frictional joining process for Nitinol and stainless steel wires ranging in diameter from 0.013? to 0.020?, without the need for tertiary metals, adhesive or ferrules is disclosed. The resulting frictional weld joint strength is approximately 80% of the tensile strength of the raw Nitinol wire with excellent bending properties.

Abstract: The present invention relates to a method of delivering drugs having e.g., anti-proliferative activity in the vascular, preferably, the cardiovascular, system locally or systematically using an at least partially drug-coated guidewire. The drug-coated guidewire, particularly an expansion member or portion thereof, is brought into contact with the target tissue or in circulation and the drugs are quickly released into the area surrounding the device in a short time after the contact step. Once the therapeutic drugs are released, they are quickly and effectively absorbed by the surrounding cells or circulation.

Abstract: A guidewire retrieval catheter includes a guidewire retrieval lumen extending lengthwise of a catheter body. An inflatable member at the distal end of the catheter body defines an inflation chamber for selectively receiving fluid to configure the inflatable member from deflated configuration to an inflated configuration. The inflatable member has an inner wall defining a guidewire retrieval cavity in communication with the guidewire retrieval lumen to facilitate insertion of the guidewire into the guidewire retrieval lumen when the inflatable member is in the inflated configuration. The guidewire retrieval catheter is used to retrieve a guidewire in a body lumen.

Abstract: A system for conducting denervation of the neural plexus adjacent the renal artery, comprises a pre-shaped ablative element operatively coupled to an elongate deployment member configured to be navigated into the renal artery, the pre-shaped ablative element comprising one or more RF electrodes disposed in an arcuate pattern; and an energy source operatively coupled to the one or more RF electrodes and being configured to cause current to flow from the pre-shaped ablative element and cause localized heating sufficient to denervate nearby neural tissue.

Abstract: An inflation device including a handle mechanism configured to selectively engage and disengage threads within the device. In some instances the threads are configured to couple a plunger to a syringe body. The handle mechanism may be configured to (1) provide a mechanical advantage and (2) change the location and direction of the input force, thereby making the device easier to use.

Abstract: Tools for determining and adjusting the setting of an adjustable valve are disclosed. These tools allow a medical professional to locate and non-invasively determine the setting of an implanted valve. After the valve has been located and the setting of the valve determined, the valve may be re-adjusted non-invasively. There are three tools: a locator tool, an indicator tool and an adjustment tool. The locator tool allows the physician to locate the adjustable valve of interest and align the locator tool with a specific orientation of the valve. The indicator tool indicates the current setting of the adjustable valve and confirms new settings of the valve after the new settings have been implemented. The adjustment tool interacts magnetically with the implanted adjustable valve to couple with a movable internal element to change the setting of the valve. The indicator tool and the adjustment tool physically cooperate with the locator tool to accomplish the respective functions of the tools.

Abstract: In various examples, an apparatus is configured for subcutaneously inserting an implantable device within a patient. The apparatus includes a dilator portion including a dilator including a dilator length. The dilator portion is configured to separate tissue to create a subcutaneous pocket within the patient sized and shaped to accommodate an implantable device within the subcutaneous pocket. A sheath portion includes a sheath sized and shaped to accommodate the dilator within a sheath lumen. The sheath is configured to accommodate an antenna of the implantable device with the dilator removed from within the sheath. The sheath includes a sheath length that is at least substantially as long as an antenna length. The sheath is configured to separate to allow removal of the sheath around the implantable device to remove the sheath from and leave the implantable device within the subcutaneous pocket within the patient.

Abstract: A dilation assembly includes a shaft and a dilator coupled with the distal end of the shaft. The dilator includes a proximal end, a distal end, and a center portion positioned between the proximal end and the distal end. The center portion dilates from a first configuration to a second configuration. The center portion has a larger diameter than the proximal end and the distal end when the center portion is in the second configuration. At least one gripping feature is positioned on at least a portion of the exterior surface of the center portion. The gripping feature provides friction between the center portion and a bodily lumen when the center portion is in the second configuration.

Abstract: Medical devices, kits, and methods are provided for delivering a fluid containing a drug to a patient. Devices (102, 402, 702) include a housing (104, 404, 704) defining a lumen and an osmotically-driven piston (420) moveable within the lumen. The housing may be elastically deformable between a first shape suitable for insertion through a patient's urethra and a second shape suitable for retention of the device in the patient's bladder.

Abstract: The present disclosure provides improved devices and methods to treat periprosthetic breast implant infections.

Abstract: A skin treatment device is provided including bioerodible polymeric microneedles which are designed to more effectively deliver beneficial agents to the skin. The device includes a flexible substrate and an arrangement, for example, an array, of microneedles projecting from the substrate.

Abstract: The invention includes catheters that have therapeutic agent- and therapeutic energy- delivery capability. In particular embodiments, the catheters include only a single therapeutic energy transducer that is configured to deliver energy to over half of the circumference of the catheter. The therapeutic catheters of the invention allow for faster and more effective thrombus removal because of the simultaneous delivery of therapeutic agents and energy.

Abstract: Fixation and protective components for use with implantable medical devices, such as access ports and catheters, are disclosed. In one embodiment, a protective sleeve is employed about a catheter so as to distribute compressive loads and ensure patency of the catheter lumen, even in areas prone to pinch-off. A catheter assembly in one embodiment thus comprises an elongate catheter tube that defines at least one lumen. A protective mesh sleeve is disposed about an external portion of the catheter tube so as to cover at least a portion of the longitudinal length of the catheter tube. The protective sleeve is configured to distribute a compressive load on the catheter tube so as to ensure patency of the at least one lumen of the catheter tube.

Abstract: A check valve for use in a fluid pathway. The check valve may have a diaphragm and a plurality of supports extending from the diaphragm. The check valve and supports have a line of symmetry, and deformation of the check valve as it moves from a closed position to an opened position can be generally along the line of symmetry.

Abstract: A system and method for aiding in the proper placement of ECG electrodes and other resuscitation parameters. The system includes motion sensors disposed on the ECG electrodes, and a defibrillator control system operable to interpret motion signals from the motions sensors to determine that an electrode is in motion, and thus being handled by rescuer setting up the system for use, and, based on this determination, prompt the rescuer to place the electrode in its intended location on the body of the patient.

Abstract: Treatment of an aneurysm or other vascular defect can be facilitated or enhanced by a galvanic cell formed by an implantable medical device configured to be implanted at or within the aneurysm or other vascular defect. The implantable medical device can include a primary structure including an anodic metal and a cathodic metal. The anodic metal and the cathodic metal each form a fraction of a total surface area of the primary structure. A galvanic cell formed by the anodic metal and the cathodic metal is configured to induce a galvanic voltage within blood for a duration of time to promote thrombosis. The thickness of the anodic metal can be less than or equal to 5 ?m, for example, to provide galvanic activity for between 5 and 30 minutes.

Abstract: A lead assembly includes a lead with a distal end and a proximal end. The had includes a plurality of electrodes disposed at the distal end and a plurality of terminals disposed at the proximal end. The lead also defines at least one central lumen and a plurality of outer lumens. The central and outer lumens extend from the proximal end to the distal end such that the plurality of outer lumens extend laterally from the at least one central lumen. The lead further includes a plurality of conductive wires. Each conductive wire couples at least one of the plurality of electrodes electrically to at least one of the plurality of terminals. At least two conductive wires are disposed in each of the plurality of outer lumens.

Abstract: Devices, systems and methods for reducing migration of leads, catheters and similar devices are provided. In particular, devices, systems and methods are provided for creating a slack anchor which assists in maintaining the lead or catheter in a desired position. In some embodiments, the slack anchor is created within the epidural space. When targeting nerve anatomy within the spinal column or in the vicinity of the epidural space, anchoring within the epidural space allows the associated lead or catheter to be anchored as close to the target therapy site as desired or possible. By anchoring close to the target therapy site, the risk of movement or migration is significantly reduced or eliminated.

Abstract: An electrical stimulation lead includes a lead body having a distal end, a proximal end, and a longitudinal length; electrodes disposed along the distal end of the lead body; terminals disposed along the proximal end of the lead body; a non-conducting core extending along lead body; and conductors extending along the lead body to electrically couple the electrodes to the terminals. The conductors include a first conductor and a second conductor arranged along the core with a non-conducting gap between the first and the second conductors. Each of the first and the second conductors includes an inner conductor portion with a first electrical resistivity and an outer conductor portion having a second electrical resistivity that is at least twice the first electrical resistivity. The outer conductor portion is disposed exclusively radially outward from the inner conductor portion.

Abstract: Devices, systems and methods are disclosed for treating a variety of diseases and disorders that are primarily or at least partially driven by an imbalance in neurotransmitters in the brain, such as asthma, COPD, depression, anxiety, epilepsy, fibromyalgia, and the like. The invention involves the use of an energy source comprising magnetic and/or electrical energy that is transmitted non-invasively to, or in close proximity to, a selected nerve to temporarily stimulate, block and/or modulate the signals in the selected nerve such that neural pathways are activated to release inhibitory neurotransmitters in the patient's brain.

Abstract: Delivery of peripheral nerve field stimulation (PNFS) in combination with one or more other therapies is described. The other therapy delivered in combination with PNFS may be, for example, a different type of neurostimulation, such as spinal cord stimulation (SCS), or a drug. PNFS and the other therapy may be delivered simultaneously, in an alternating fashion, according to a schedule, and/or selectively, e.g., in response to a request received from a patient or clinician. A combination therapy that includes PNFS may be able to more completely address complex or multifocal pain than would be possible through delivery of either PNFS or other therapies alone. Further, the combination of PNFS with one or more other therapies may reduce the likelihood that neural accommodation will impair the perceived effectiveness PNFS or the other therapies.

Abstract: A hearing signal processor processes an input sound signal and generates an electrical communications signal for an upper range of sound frequencies, and an acoustic communications signal for a lower range of sound frequencies. An implanted electrical stimulation subsystem includes an electrode array with one or more electrode contacts in an acoustically perceivable cochlear region retaining residual natural hearing. The electrical stimulation subsystem receives the electrical communications signal and delivers corresponding electrical stimulation signals to the electrode contacts for electrical stimulation of adjacent neural tissue. An external acoustic stimulation subsystem receives the acoustic communications signal and delivers corresponding amplified acoustic stimulation signals to the ear canal of the patient.

Abstract: A signal processing arrangement generates electrical stimulation signals to electrode contacts in an implanted cochlear implant array. An input sound signal is analyzed to determine characteristic frequency components. One or more stimulation events are requested based on the timing and amplitude of the frequency component. A frequency-specific stimulation sequence (FSSS) is generated for stimulation of a plurality of adjacent electrode contacts. The FSSS starts with a stimulation pulse to the highest-frequency, most-basal electrode contact of the adjacent electrode contacts, ends with a stimulation pulse to the lowest-frequency, most-apical electrode contact of the adjacent electrode contacts, and reaches a maximum stimulation amplitude at a frequency-specific location within the cochlea corresponding to a natural traveling wave maximum. The electrode stimulation signals are then generated from the FSSS for delivery by the electrode contacts to adjacent auditory neural tissue.

Abstract: A signal processing arrangement generates electrical stimulation signals to stimulation contacts in an implanted cochlear implant array. An input sound signal is decomposed into dominant psychophysically relevant frequency components, with each frequency component changing over time in frequency and level. Each frequency component is coded as a patient-specific, frequency-specific function of stimulation location, rate, and level to produce a sequence of requested stimulation events having an instantaneous frequency and level. And the electrical stimulation signals are generated from the requested stimulation events for delivery by the stimulation contacts to adjacent auditory neural tissue.

Abstract: The present invention is a new configuration for the external portion of a visual prosthesis in the form of a visor or glasses, including a frame supported by a user's nose and ears. The video processing unit is adapted to be connected by temple portions of the visor and rest on the user's upper back behind the user's neck, or behind the user's head. Controls for the video processor are on one or both temple portions of the visor.

Abstract: Methods and devices for verifying that proper visual stimulation is applied to the visual prostheses are described. In one of the methods, a visual stimulation system implanted on a subject is simulated externally. An external testing device is also discussed.

Abstract: A method for improving speech recognition, involving assessing a subject's speech recognition ability, selecting a set of speech sounds appropriate for speech recognition training, providing a paired training therapy, and repeating the paired training therapy. The paired training therapy involves selecting a speech sound from the set of speech sounds and introducing said speech sound while concurrently stimulating the subject's vagus nerve.

Abstract: The present invention provides a closed-loop system for real-time control of epidural and/or subdural electrical stimulation comprising: means for applying to a subject neuromodulation with adjustable stimulation parameters, said means being operatively connected with a real-time monitoring component comprising sensors continuously acquiring feedback signals from said subject, said signals being neural signals and/or signals providing features of motion of said subject, said system being operatively connected with a signal processing device receiving said feedback signals and operating real-time automatic control algorithms, said signal processing device being operatively connected with said means and providing said means with new stimulation parameters, with minimum delay. The system of the invention improves consistency of walking in a subject with a neuromotor impairment.

Abstract: An exemplary method for optimizing pacing configuration includes providing distances between electrodes of a series of three or more ventricular electrodes associated with a ventricle; selecting a ventricular electrode from the series; delivering energy to the ventricle via the selected ventricular electrode, the energy sufficient to cause an evoked response; acquiring signals of cardiac electrical activity associated with the evoked response via non-selected ventricular electrodes of the series; based on signals of cardiac electrical activity acquired via the non-selected ventricular electrodes and the distances, determining conduction velocities; based on the conduction velocities, deciding if the selected ventricular electrode is an optimal electrode for delivery of a cardiac pacing therapy; and, if the selected ventricular electrode comprises an optimal electrode for delivery of the cardiac pacing therapy, calling for delivery of the cardiac pacing therapy using the selected ventricular electrode.

Abstract: Disclosed are methods for regulating neurotrophin levels within a human body. The invention utilizes an implantable signal generator to deliver stimulation to neural tissue elements. Alternatively, an implantable pump may be utilized to delivery one or more drugs. The implanted device delivers treatment therapy to the neural tissue to thereby alter the level of neurotrophic factors such as BDNF expressed by the influenced neural tissue. A sensor may be used to detect various symptoms of a nervous system disorder. A microprocessor algorithm may then analyze the output from the sensor to regulate the treatment therapy delivered to the body. The invention describes a novel method to regulate the intrinsic levels of neurotrophins and may be used to treat patients with neurological and cognitive disorders.

Abstract: An implantable medical device (IMD) is disclosed having measurement circuitry for measuring one or more currents in the IMD, such as the currents drawn from various power supply voltages. Such currents are measured without disrupting normal IMD operation, and can be telemetered from the IMD for review. Switching circuitry in line with the current being measured is temporarily opened for a time period to disconnect the power supply voltage from the circuitry being powered. A voltage across a capacitance in parallel with the circuitry is measured when the switching circuitry is opened and again closed at the end of the time period, with the circuitry drawing power from the charged capacitance during this time period. The average current drawn by the power supply voltage is determined using the difference in the measured voltages, the known capacitance, and the time period between the measurements.

Abstract: According to an embodiment of a method for providing neural stimulation, activity is sensed, and neural stimulation is automatically controlled based on the sensed activity. An embodiment determines periods of rest and periods of exercise using the sensed activity, and applies neural stimulation during rest and withdrawing neural stimulation during exercise. Other embodiments are provided herein.