Abstract: A mask assembly is provided for delivering gas to a patient that includes a mask body and a breathing circuit interface. The mask body includes an opening for reception of the gas and includes a seal structure for sealingly engaging with the face of the patient and surrounding at least the nose and mouth of the patient. The breathing circuit interface includes a first portion rotatably connected with the mask body and a second portion that is constructed and arranged to releasably connect with a conduit for delivering the gas to the patient through the opening.

Abstract: A component useable with one or more tube comprises a body engageable with one or more external surface recesses of the one or more tubes. The component has a pair of jaws extending from the body for gripping an item. The component is configured, such that, in use, in a first orientation of the body relative to the respective tube(s) recesses, the component is movable along a length of the tube(s); and, in a second orientation of the body relative to the respective tube(s) recesses, the component is resistive to movement along a length of the tube(s).

Abstract: This disclosure relates to a portable oxygen concentrator system. The system includes a case containing a portable oxygen concentrator, a mask, and a button. The case is configured to be worn on a user's back. The mask is configured to deliver oxygen from the portable oxygen concentrator to the user. The button, when activated, is configured to cause the portable oxygen concentrator to deliver an increased flow of oxygen to the user for a period of time.

Abstract: A pressure support system for delivering a flow of breathing gas to an airway of a patient includes a base unit structured to generate the flow of breathing gas and including a heating control unit, a conduit coupled to the base unit and structured to carry the flow of breathing gas, a thermistor disposed in the conduit, and first and second resistive wires extending along the conduit from the base unit to the thermistor. The heating control unit is structured to selectively operate in a first mode to heat the conduit using the first and second resistive wires and a second mode to sense a temperature of airflow in the conduit with the thermistor via the first and second resistive wires.

Abstract: Methods and systems for using augmented reality (AR) technology in the mental health/developmental disorder treatment field. More particularly, methods and systems for providing a mental health/developmental disorder treatment service, process and system that introduces an input of a licensed healthcare professional into a patient's field of vision while he or she is utilizing a wearable medical device or wearable device.

Abstract: Disclosed is a method of enhancing exposure therapy including providing an exposure therapy to a patient and stimulating the patient's vagus nerve at the same time as the exposure therapy. Also disclosed is a post-traumatic stress disorder therapy method including providing an exposure event to a patient and stimulating the patient's vagus nerve during the exposure event. Also disclosed is a phobia disorder therapy method including providing an extinction event to a patient and stimulating the patient's vagus nerve during the exposure event. Also disclosed is an obsessive compulsive disorder therapy method including providing a therapy event to a patient and stimulating the patient's vagus nerve during the therapy event. Also disclosed is an addiction disorder therapy method including providing a therapy event to a patient and stimulating the patient's vagus nerve during the therapy event.

Abstract: In an exemplary embodiment, a body pillow 1 includes: a cushion part 10 of hollow construction made of a transparent and flexible material; leg parts 20 extending downward from the bottom face of the cushion part to create an air flow passage S underneath the bottom face; and affixing means 40 for affixing video playback devices 30 to the bottom face of the cushion part with their video display surfaces 31 facing up. The body pillow has video playback devices provided on the bottom face of a transparent cushion part, so the user can view a video in various postures such as lying face down, face up, or sideways.

Abstract: The present disclosure is directed to an over-the-needle (OTN) catheter assembly having a structural member configured therein. The OTN catheter assembly includes a catheter coaxially mounted onto a needle. In one embodiment, the structural member includes a coil insert that is embedded into an interior wall of the catheter, thereby preventing kinking of the catheter when being inserted within a patient. In another embodiment, the structural member may be a separate and removable coil insert that is inserted into the catheter after the OTN catheter assembly has been placed in a targeted site within the patient and the needle is removed. In a further embodiment, the structural member may be a separate and removable solid insert having a blunt distal end that is inserted into the catheter after the OTN catheter assembly has been placed in a targeted site within the patient and the needle is removed.

Abstract: A catheter assembly includes a flexible catheter having a lumen, a hub having a body including a proximal end and a distal end, the body defining a passageway extending from the proximal end to the distal end, the hub being coupled to one end of the catheter, and the passageway of the hub being in fluid communication with the lumen of the catheter, and a coupler including a base coupleable to and detachable from the hub, the base being coupled to at least one introducer assembly, each of the at least one introducer assembly including a port, a tubing and a hollow needle.

Abstract: A catheter having a catheter shaft and a tip. The catheter shaft includes an inner layer, a first reinforcing layer disposed around an outer periphery of the inner layer, an intermediate layer, a second reinforcing layer disposed around an outer periphery of the intermediate layer, and an outer layer that covers the second reinforcing layer. The tip includes a proximal end portion that extends in an axial direction of the catheter and is joined to at least the intermediate layer and the outer layer, between the first reinforcing layer and the second reinforcing layer. The proximal end portion increases the joining strength between the intermediate layer and the tip and the joining strength between the outer layer and the tip. As a result, it is possible to prevent the tip from easily detaching from the catheter shaft.

Abstract: Methods, apparatuses and systems are described for providing access to a body lumen. The access system may include an access catheter with a lumen extending from a proximal end to a distal end of the access catheter and a stylet configured to fit within the lumen of the access catheter. The stylet may include a lumen extending from a proximal end to a distal end of the stylet and a piercing tip at the distal end of the stylet configured to protrude from the distal end of the access catheter. The access system may be advanced adjacent to the body lumen and the piercing tip of the stylet may pierce the wall of the body lumen by advancing the stylet and the access catheter together.

Abstract: Provided is a system for advancing an article along a path. The system may include a head member; a dispatching member, and an eversion sleeve configured with an inverted portion having a sleeve end configured to be fixed to the dispatching member. The system may also include an everting portion configured for articulating to the head member and an un-inverted portion configured to extend from the everting portion towards the dispatching member, at least partially within the inverted portion.

Abstract: A deflectable catheter with biased deflection characteristics has an elongated catheter body having a micro-injection molded spine that is configured with a center core, outwardly extending opposing struts, and one or more sets of longitudinally-aligned and discrete fins, wherein the struts resist deflection of the spine in a first plane and bias deflection of the spine in a second plane, wherein parameters of the discrete fins define deflection characteristics of the spine in the second plane.

Abstract: Anchors for securing a medical device relative to a body portal, wherein the anchors may accommodate most any implantation trajectory through the portal. Such anchors may further secure the device along any such trajectory without imparting undesirable biasing forces that may shift the device from its intended implanted location. In some embodiments, the anchor is configured as a burr hole anchor including a spherical member contained in a socket of the anchor such that orientation of the spherical member is permitted about three mutually perpendicular axes.

Abstract: An apparatus comprising a first component; a second component; and a locking element adapted to selectively couple the first and second components together, wherein the locking element is rotatable between a first position and a second position, wherein the apparatus is adapted to secure a catheter between the first and second components when the locking element is in the first position, and wherein the catheter is removable from the apparatus when the locking element is in the second position.

Abstract: A low-profile universal passive protector is provided for an IV catheter comprising a hypodermic needle and a catheter. An elongate sheath defines a sheath cavity and a longitudinal axis. A slider is connected to the hypodermic needle and is movable along the sheath between first and second positions for withdrawing the needle into the sheath. A finger-press plate is coupled to the sheath and extends beyond the slider in a direction perpendicular to the longitudinal axis to define a plate height. A flashback body is coupled to the slider in a manner such that the flashback body and slider collectively define a cavity in fluid communication with the hypodermic needle. The flashback body is sized and configured to extend from the slider in a direction perpendicular to the longitudinal axis to define a flashback body height that is less than the plate height.

Abstract: An apparatus and method of manufacture includes a helical wire coil body having a proximal body end portion and a distal body end portion that extend along a longitudinal coil axis. The apparatus also includes a non-extensible, core wire assembly configured to inhibit longitudinal elongation of the helical wire coil body along the longitudinal coil axis. The core wire assembly has a first core wire and a second core wire respectively extending from the proximal body end portion toward the distal body end portion. The second core wire proximally terminates relative to the first core wire such that the distal body end portion is more flexible than the proximal body end portion. The first and second core wires transversely overlap to provide a collective column strength to the helical wire coil body along the longitudinal coil axis.

Abstract: Medical devices and methods for making and using a medical device are disclosed. An example medical device may include a guidewire for accessing and treating a region of the neural vasculature. The guidewire may include an elongate shaft having a distal end region. The elongate shaft may include an inner tubular member and an outer tubular member. The inner tubular member may have a plurality of openings formed therein. The outer tubular member may have a plurality of slots formed therein. An occlusive balloon may be coupled to the distal end region of the elongate shaft and disposed about at least some of the plurality of openings. The inner tubular member may define a lumen in fluid communication with the occlusive balloon through the plurality of openings. The tip member may be coupled to the distal end region of the elongate shaft.

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 to release the drug into the bloodstream to produce a therapeutic effect. The preparation can be operably coupled to delivery means 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: Provided herein is an implant for delivering a hydrophobic active agent to a target tissue. The implant may include a scaffold defining a first surface and a second surface opposite the first surface, wherein the scaffold is substantially impermeable to a hydrophobic active agent, and a silicone tubing having a wall permeable to the active agent, wherein a first length of the silicone tubing is affixed to the first surface of the scaffold, wherein the two ends of the silicone tubing extend from the first surface, and wherein a path outlined by a second length of the tubing within the first length is circuitous. Also provided is a method of using the implant to locally deliver a hydrophobic active agent to a target tissue, and kits that find use in performing the present method.

Abstract: A device used for applying an antiseptic preparation, such as an antibiotic solution or water, or all other substance deemed necessary in treating a wound prior to arrival at a hospital or other treatment facility or for continuing wound therapy and maintenance while hospitalized, in an out-patient facility or at home. A loose-fitting bag is provided which encloses the wound by securing the open end(s) to the patient by closing means. The bag further includes ports or resealable flaps that allow access to the wound for treatment and cleaning while containing all fluids resulting therefrom. A high friction scrub surface is provided in the bag. A method and apparatus are also provided for wound maintenance with a lavage system.

Abstract: In an aspect of the invention, an array of microprotrusions is formed by providing a mold with cavities corresponding to the negative of the microprotrusions, casting atop the mold a first solution comprising a biocompatible material and a solvent, removing the solvent, casting a second solution atop the first cast solution, removing the solvent from the second solution, and demolding the resulting array from the mold. The first solution preferably contains an active ingredient.

Abstract: Applicators for a microprojection array and methods of using the applicators are described.

Abstract: A microneedle patch includes: a patch layer which is a flat layer; and a microneedle which is disposed on one surface of the patch layer, includes an air-pocket therein, and formed of a polymer having at least one of swellability and solubility. The air-pocket is disposed in a lower end of the microneedle which is in contact with the patch layer. The patch layer includes a needle layer on one surface of the patch layer, and the microneedle is disposed on an opposite surface to one surface of the needle layer which is in contact with the patch layer.

Abstract: An adapter set that is attached to artery-side and vein-side shunt connectors-that are provided on a blood circuit. The adapter set includes: an artery-side adapter that has one end thereof connected to the artery-side shunt connector, has the other end thereof connected to a drainage port that is provided on the outside of the blood circuit, and thereby connects the artery-side shunt connector and the drainage port fluid tight; and a vein-side adapter that has one end thereof connected to the vein-side shunt connector, has the other end thereof connected to a supply port that is provided on the outside of the blood circuit, and thereby connects the vein-side shunt connector and the supply port fluid tight. The structure of the other end of the artery-side adapter and the structure of the other end of the vein-side adapter are different.

Abstract: A connector for fluidly coupling proximal and distal tubular segments of a fluid conduit is provided. In one embodiment, the connector can include a connector body having an outer surface defining a first outer perimeter and an inner surface defining a lumen. The connector can also include a connecting device having an open configuration and a plurality of closed configurations. The connecting device can include first and second members configured to engage each other to secure the fluid conduit to the connector. The connecting device can also include a plurality of closed configurations for securing fluid conduits of different sizes.

Abstract: A male connector is connectable to a female connector and includes: a flow path tubular member that has an opening at an end portion; a valve body that closes the opening; a housing main body; and a moving body that moves with respect to the housing main body and deforms the valve body so as to change a mode between a first mode in which the opening is closed by the valve body and a second mode in which the opening is open from the valve body. The moving body includes a locking portion that locks the female connector in a state in which the valve body and an elastic valve body of the female connector abut on each other.

Abstract: The present invention relates to electroporation (EP) devices that are able to generate an electroporation causing electrical field at the mucosal layer, and preferably in a tolerable manner. Further, it includes the generation of a protective immune response, cellular and/or humoral, using the oral EP device along with a genetic construct that encodes an immunogenic sequence.

Abstract: An apparatus (1) far the therapeutic treatment of a user's tissue injury comprising a control unit (2), to which aft applicator (3) is connected adapted to be positioned in proximity of the tissue injury to be treated is described, said control unit (2) being configured to generate at the applicator (3) an electric field adapted to be applied on the tissue injury. The control unit (2) is also configured, to generate an air or oxygen flow which is directed to the applicator (3), and to transform at the applicator (3) the air or oxygen flow into an ozone flow adapted to be diffused and applied on the tissue injury in combination with said electric field.

Abstract: An implantable electrode arrangement for a cochlear implant system is described. A retraction limiter fits around and securely engages a portion of the distal end of an electrode lead. The retraction limiter includes flexible retraction limiting projections longitudinally distributed along its outer surface. An insertion tube fits around the electrode array and the retraction limiter and engages against the outer surface of the patient cochlea at a cochlear opening. An insertion plunger fits within the insertion tube and engages against the proximal end of the retraction limiter. The insertion plunger slides within the insertion tube to push against the proximal end of the retraction limiter to push the electrode array through the cochlear opening into the patient cochlea.

Abstract: A method and apparatus for the concurrent treatment of multiple oral diseases and defects while promoting general oral hygiene utilizing direct current electricity and methods for manufacturing the same. Electrodes are used to deliver a direct current to the gingival tissues of a mouth in order to achieve a number of therapeutic, prophylactic, and regenerative benefits. These benefits include killing oral microbes, increasing oral vasodilation, reducing oral biofilm, improving oral blood circulation, reversing oral bone resorption, promoting oral osteogenesis, treating gum recession, and fostering gingival regeneration. Other benefits include the treatment of gingivitis, periodontitis, and oral malodor, and other systemic diseases correlated with oral pathogens.

Abstract: An electrical stimulation control circuit including a pulse generator, a processing circuit and an electrode is provided. The pulse generator is configured to generate a switching signal. The processing circuit generates an energy signal according to the switching signal. The electrode is configured to contact the skin of a living body and includes a first comb electrode and a second comb electrode. The first comb electrode receives the energy signal and includes a plurality of first electrodes. The first electrodes are electrically connected to each other and extended along a first direction. The second comb electrode receives a ground signal and includes a plurality of second electrodes. The second electrodes are electrically connected to each other and extended along a second direction opposite to the first direction. The first electrodes and the second electrodes are arranged in a staggered manner and electrically insulated from each other.

Abstract: A method of preventing infection resulting from implanting a medical device. The method includes installing a polymer device at least substantially within a subcutaneous pocket formed to contain a housing of the medical device, and installing the medical device housing in the subcutaneous pocket. The polymer device includes a bioresorbable polymer structure and an antimicrobial agent configured to elute from the polymer structure. The polymer device covers less than about 20% of the surface area of the medical device housing.

Abstract: Systems, devices, and methods are discussed herein for wirelessly transmitting power and/or data to an implanted device, such as an implanted electrostimulator device. In an example, the subject matter includes a layered transmitter device with multiple conductive planes and excitation features. The transmitter device can be tuned to identify and apply device parameters for efficient wireless communication with a deeply implanted device. The transmitter is generally configured for midfield powering applications by providing signals that give rise to propagating signals inside of body tissue.

Abstract: One aspect of the present disclosure relates to a system that can provide an incomplete nerve block to a patient. In some instances, the incomplete nerve block can be bi-directional. In other instances, the incomplete nerve block can be adjustable. The system can include a waveform generator that can provide temporary electrical nerve conduction block to a nerve using an electrode. The electrode can include at least one contact. The temporary electrical nerve conduction block can block conduction in less than 100% of the fibers within the nerve located in close proximity to or being surrounded by the electrode. The temporary electrical nerve conduction block does not cause intentional damage to neural tissue as mode of action to achieve the incomplete nerve block. A complete recovery of nerve conduction can be expected post application of the incomplete nerve block.

Abstract: This application describes a miniature implantable neurostimulator system for sciatic nerves and their branches. The implanted miniature neurostimulator is implanted in the leg and stimulates these nerves for the treatment of urinary or bowel incontinence. The miniature implantable neurostimulator has a low duty cycle permitting a small size with medically-acceptable longevity. The system includes a wireless programmer and patient-activated key fob.

Abstract: Devices, systems and methods are disclosed for treating or preventing gastroparesis, functional dyspepsia, and other functional gastrointestinal disorders. The methods comprise transmitting impulses of energy non-invasively to selected nerve fibers, particularly those in a vagus nerve. The methods provide damaged interstitial cells of Cajal (ICC) with trophic factors via vagal afferent nerve fibers, thereby reversing ICC damage, and as a consequence improving gastric motility. The methods also increase levels of inhibitory neurotransmitters in the brain so as to decrease neural activity within the area postrema, or they deactivate a resting state neural network containing parts of the anterior insula and anterior cingulate cortex, which will thereby reduce abnormal interoception and visceral hypersensitivity.

Abstract: Systems and methods for controlling a tissue of a subject using applied pulsed electric fields. The system includes an electrode assembly configured to engage a skin tissue of a subject to deliver a series of electric field pulses to the skin tissue and a user input configured to receive an operational instruction for the series of electric field pulses. The system also includes at least one processor configured to access the operational instruction received by the user input and, using the operational instruction, create an electric field profile to be generated by the electrode assembly about the skin tissue of the subject to control a fibroblast characteristic while preserving a vascular perfusion in at least a portion of the skin tissue. The processor is also caused to control the electrode assembly using the electric field profile to deliver the series of electric field pulses to control the fibroblast characteristic.

Abstract: Techniques are described for discriminating SVT and, in particular, rapidly conducting AF. The techniques include detecting an onset of a fast rate of ventricular events sensed from a cardiac electrical signal and detecting a pause in the fast rate of ventricular sensed events. A threshold number of ventricular event intervals required to detect a ventricular tachyarrhythmia is detected with each of the threshold number of ventricular event intervals being less than a tachyarrhythmia detection interval. Detection of the ventricular tachyarrhythmia and an electrical stimulation therapy for treating the ventricular tachyarrhythmia are withheld in response to at least the pause being detected.

Abstract: A method is provided for implanting, in an eye of a subject, an implantable retinal stimulator having (i) an electrode array including electrodes; (ii) a plurality of photosensors; and (iii) driving circuitry, configured to drive the electrodes to apply currents to a retina of the eye. A surface of the retina is contacted with a tissue-contact surface of an anchoring-element-receiving portion of a frame. Subsequently, the frame is anchored to the retina by penetrating scleral tissue of the subject by advancing an anchoring element through an opening defined by the anchoring-element-receiving portion of the frame and into the scleral tissue such that the anchoring element secures the frame to the retina. Subsequently, using the frame, the implantable retinal stimulator is positioned in an epi-retinal position such that the electrode array penetrates the retina. Other embodiments are also described.

Abstract: Systems, methods, and devices for neuromodulation are described herein. For example, a method for modulating inflammatory processes of a subject is described. The method can include stimulating the subject's vagus nerve to activate an efferent pathway, and stimulating the subject's vagus nerve to inhibit neural activity. Pairing activation of the efferent pathway and inhibition of neural activity can enhance an anti-inflammatory response of the subject.

Abstract: An external control device and method for programming an implantable neuromodulator coupled to an electrode array implanted adjacent tissue of a patient having a medical condition. Electrical modulation energy is conveyed to tissue of the patient in accordance with a series of modulation parameter sets. The patient perceives paresthesia in response to the conveyance of the electrical modulation energy to the tissue in accordance with at least one of the modulation parameter sets. One of the modulation parameter set(s) is identified based on the perceived paresthesia. Another modulation parameter set is derived from the identified modulation parameter set. Electrical modulation energy is conveyed to the tissue of the patient in accordance with the other modulation parameter set without causing the patient to perceive paresthesia.

Abstract: An external control device, neuromodulation system, and method of providing therapy to a patient using an implantable neuromodulator implanted within the patient. Electrical modulation energy is delivered from the neuromodulator to the patient in accordance with the pre-existing modulation program when in one of the super-threshold delivery mode and the sub-threshold delivery mode. Operation of the neuromodulator is switched to the other of the super-threshold delivery mode and the sub-threshold delivery mode. A new modulation program may be derived from a pre-existing modulation program, and the neuromodulator may deliver the electrical modulation energy to the patient in accordance with the pre-existing modulation program during the other of the super-threshold delivery mode and the sub-threshold delivery mode.

Abstract: An example of a system may include an electrode arrangement and a neuromodulation device configured to use electrodes in the electrode arrangement to generate a neuromodulation field. The neuromodulation device may include a neuromodulation generator, a neuromodulation control circuit and a storage. The storage may include a stochastically-modulated neuromodulation parameter set and the stochastically-modulated neuromodulation parameter set may include at least one stochastically-modulated parameter. The controller may be configured to control the neuromodulation generator using the stochastically-modulation parameter set to generate the neuromodulation field.

Abstract: A method and apparatus are disclosed for treating a variety of conditions include treating a disorder associated with neural activity near a region of a brain. In such condition, the method includes placing an electrode to create a field near said region, creating said field with parameters selected to at least partially block neural activity within said field. For treating a tissue sensation, the method includes identifying a target area of tissue to be treated and placing an electrode to create a field near the target area, and creating the field with parameters selected to at least partially block neural activity within the target area. For treating a condition associated with neural activity of a spinal cord, the method includes placing an electrode to create a field near a nerve associated with the spinal cord, and creating the field with parameters selected to at least partially block neural activity within the nerve.

Abstract: This document discusses, among other things, systems and methods for delivering electrostimulation to specific tissue of a patient. An example of a system can receive a three-dimensional voxelized model representing a plurality of regions each specified as a target region or an avoidance region. The system includes control circuitry to determine a metric value using the voxelized model. The metric value indicates a clinical effect of electrostimulation on the plurality of regions according to a stimulation current and a current fractionalization. The control circuitry can determine a desired stimulation current that results in a first metric value satisfying a clinical effect condition. The system can generate a stimulation configuration including the desired stimulation current and the current fractionalization corresponding to the first metric value, and deliver tissue stimulation according to the stimulation configuration.

Abstract: Modulation, preferably inhibition, of neurosignaling of a cardiac-related sympathetic nerve in the extracardiac intrathoracic neural circuit is effective in stabilizing cardiac electrical and/or mechanical function, thereby providing ways of treating or preventing cardiac dysfunction such as arrhythmias.

Abstract: One aspect of the present disclosure relates to a system that can prevent unintended signal components (noise) in an electric waveform that can be used for at least one of neural stimulation, block, and/or sensing. The system can include a signal generator to generate a waveform that includes an intended electric waveform and unintended noise. The system can also include a signal transformer device (e.g., a very long wire) comprising a first coil and a second coil. The first coil can be coupled to the signal generator to receive the waveform and remove the unintended noise from the electric waveform. The second coil can pass the electric waveform to an electrode. The second coil can be coupled to a capacitor that can prevent the waveform from developing noise at an electrode/electrolyte interface between an electrode and a nerve.

Abstract: A computer implemented system and method facilitates a cycle of generation, sharing, and refinement of volumes related to stimulation of anatomical tissue, such as brain or spinal cord stimulation. Such volumes can include target stimulation volumes, side effect volumes, and volumes of estimated activation. A computer system and method also facilitates analysis of groups of volumes, including analysis of differences and/or commonalities between different groups of volumes.

Abstract: A computer implemented system and method facilitates a cycle of generation, sharing, and refinement of volumes related to stimulation of anatomical tissue, such as brain or spinal cord stimulation. Such volumes can include target stimulation volumes, side effect volumes, and volumes of estimated activation. A computer system and method also facilitates analysis of groups of volumes, including analysis of differences and/or commonalities between different groups of volumes.