Abstract: An endotracheal tube comprising a tubular member including a distal portion and a distal end, a radiopaque stripe extending longitudinally along the distal portion of the tubular member, and a radiopaque ring encircling at least a portion of the tubular member at the distal end. The radiopaque ring may be a complete oval, a substantial arc of an oval, or a series of arcs of an oval.

Abstract: The present invention is a gel cushion that is placed on a user's nose bridge before putting on a ventilator mask. The gel cushion is composed of a tacky gel material, such as a viscoelastic polymer gel. The gel cushion is wider than the edges of the ventilator mask and remains in place even if the mask is repositioned. The gel cushion adapts to the user's face in the area on and around the nose bridge to cushion and seal the ventilator mask in that area.

Abstract: A patient interface device includes an elastomeric contacting portion that is structured to directly engage the skin of the user. The contacting portion has an engineered surface that includes a plurality of non-random, predesigned surface features designed to reduce friction and improve user comfort. In one implementation, the pitch between each immediately adjacent pair of the surface features is less than or equal to a predetermined maximum pitch value, and the height of each of the surface features is less than or equal to a predetermined maximum height value.

Abstract: A respiratory mask assembly for delivering breathable gas to a patient includes a frame and an elbow assembly. The frame has a front surface and a rear surface adapted in use to face the patient. The frame includes a main body providing an aperture therethrough for the introduction of breathable gas into a nasal breathing cavity. The elbow assembly is swivelably coupled to the front surface of the frame. The elbow assembly includes a swivel elbow that defines an intake port and an exhaust port separated from the intake port using a baffle. The elbow assembly includes an end portion that interfaces with the aperture of the frame.

Abstract: The accurate measurement of inspired and expired gas volume flow and gas composition are important in respiratory therapy. The invention provides a gas flow sensor for a ventilator comprising: a flow path extending between a first end that connects to a supply of gas and a second end that couples to a patient airway interface; and a constant temperature anemometer sensor arranged within the flow path between those ends. It further comprises a sampling port that may be coupled to a gas analyser device; and an orifice which is in fluid communication with the flow path and the sampling port so that, in use, gas may be drawn from the flow path for analysis, the gas being drawn from the flow path at a position located between the anemometer sensor and the first end.

Abstract: A combination positive airway pressure (PAP) or continuous positive airway pressure (CPAP) and resuscitation system and related methods. The systems can be well-suited for use in providing CPAP therapy for a neonate or infant patient, with the ability to also provide resuscitation therapy at a peak inspiratory pressure (PIP) as needed or desired without switching to another system or switching the patient interface. The system can include an expiratory pressure device capable of regulating a positive end expiration pressure (PEEP) of the system, which preferably can also induce pressure oscillations relative to a mean PEEP.

Abstract: A method and system for sound-induced sleep is provided. The method includes detecting brainwave signals of a subject. The method further includes analyzing the brainwave signals to determine a current sleepy state of the subject and selecting a sound in response to the current sleepy state based on a quantified association index between the brainwave signals and acoustical features of the sound. The method further more includes playing the sound to the subject.

Abstract: A user monitoring device system includes a user monitoring device with a microphone and sensors to determine air quality, sound level/quality, light quality and ambient temperature near the user. A movement detection device detects a user's movement information. The movement detection device and the monitoring system assist to determine user sleep information and sleep behavior information. The microphone records user movement sounds detected by the movement detection device. The movement detection device is configured to cause the microphone to stop recording user movement sounds when the movement sounds are not directed to a sleep related parameter. In response to determining user sleep information or sleep behavior information the system is used for treatment of sleep or psychiatric disorders.

Abstract: Tubular devices are provided that include a proximal end, a distal end sized for introduction into a patient's body, a central lumen, a conductor extending between the proximal and distal ends adjacent the central lumen, reinforcement members including windings extending helically around the central lumen, and an outer jacket. The tubular device includes a first portion in which the conductor extends helically around the central lumen, and a second portion in which the conductor extends longitudinally and either a) all of the windings surround the central lumen and the conductor remains outside the windings, b) at least some of the windings pass between the central lumen and the conductor and at least some of the windings surround both the central lumen and the conductor, and c) all of the windings surround both the central lumen and the conductor. Methods for making such tubular devices are also provided.

Abstract: A catheter that comprises a hub, an elongated conduit, and at least one lumen therein. The lumen includes a proximal lumen section, a distal lumen section, and an intermediate lumen section extending between the proximal and distal lumen sections. The cross-sectional dimension of the intermediate lumen section is less than the cross-sectional dimension of the distal lumen section. In one embodiment, the cross-sectional dimension of the intermediate lumen section is less than the cross-sectional dimension of the proximal lumen section. In certain embodiments, the lumen tapers from the dial and/or proximal lumen sections to the intermediate lumen section.

Abstract: A sphenocath including a sheath assembly including a sheath hub with a sheath tube extending therefrom with a passage extending from a proximal end of the sheath hub to a distal end of the sheath tube; a catheter assembly including a catheter hub with a catheter tube extending therefrom with a passage extending from a proximal end of the catheter hub to a distal end of the catheter tube; wherein the catheter assembly passes through the sheath assembly with a portion of the catheter hub engaging a portion of the sheath hub to limit relative rotation between the hubs while permitting relative axial movement such that in an initial non-extended position the distal end of the catheter tube is proximate to the distal end of the sheath tube. A system further including a guidewire is also provided.

Abstract: The present disclosure provides a strong, flexible catheter shaft for use in a catheter system. The flexible catheter shaft includes a nitinol tube having one or more sets of cuts therein in combination with one or more outer jacket layers. The flexible catheter shaft provides a shaft having sufficient stiffness and kink resistance to allow an operator to advance an electrode basket connected to the flexible catheter shaft through a guide catheter to a target ablation site without causing vessel trauma. The distal tip of the flexible catheter shaft is designed to have sufficient flexibility to reduce any risk of kicking out a guide catheter when tracking the electrode basket around turns in the vasculature of a patient.

Abstract: A catheter includes an inner layer, and a braid provided on an outer periphery of the inner layer. The braid includes a first wire and a second wire that are woven together. The catheter further includes a tip provided on a distal end of the inner layer and a distal end of the braid. A residual portion having a sharp shape formed at a distal end of the first wire when the first wire is cut is not left untreated, but is formed into a bulging portion.

Abstract: Disclosed herein are a method and a medical system for utilizing of an intravascular ECG signal for central venous catheter placement. The medical system is capable of detecting the position of a catheter tip and assessing its location relative to the cavoatrial junction. The detection and assessment are performed by a multiscale analysis of the complexity of the intravascular signal data points.

Abstract: Various embodiments enable an introducer for a catheter to be rotated around an axis and/or traversed backward and/or forward along the axis. In various embodiments, positioning of an introducer may be enabled by an introducer support configured to be rotated around an axis and/or extended or retracted along the axis. The introducer may be manually operated and/or operated by motors in a nose cone of a catheter positioning system. In various embodiments, a portion of the introducer support may be configured to flex. In other embodiment, positioning of an introducer may be enabled by an adjustable nose cone of a catheter positioning system.

Abstract: A suctioning and irrigating sinus balloon catheter is provided for treating a patient's paranasal sinus system, including dilating prepared openings, and natural ostia and ducts and excising sinus cavities and choana. The catheter has a number of fluid carrying conduits to provide irrigation, suction and inflation/deflation to the distally mounted balloon. The catheters have sufficient stiffness and column strength that the balloon carrying distal segment of the catheter can be pushed into the prepared opening, natural ostium or duct, choana or sinus to be excised. Some catheters can be hand bendable by the surgeon. Some catheters provide the capability of threading an endoscope through one of the conduits. The methods use the balloon catheters to dilate prepared openings to selected parts of the sinus system, to dilate natural ostia and ducts of the sinus system, choana, and/or to dilate sinus cavities to remove them.

Abstract: In one aspect, the present invention provides implantable or insertable urological medical devices, which are adapted to deliver one or more urologically beneficial agents in pharmaceutically effective amounts. In one aspect, the invention provides medical devices in which urologically beneficial agents are delivered using a porous membrane.

Abstract: Provided are methods, systems, and kits of properly delivering a biodegradable stent into a body lumen of a subject. More particularly, provided are methods, systems, and kits of properly delivering a biodegradable ureteral stent into the kidney and the bladder of a subject. Even more particularly, provided are methods, systems, and kits of properly delivering a chitosan based stent into a body lumen of a subject. Even more particularly, provided are methods, systems, and kits of properly delivering a chitosan based ureteral stent into the kidney and the bladder of a subject.

Abstract: The present invention provides a tissue expander (10) comprising a self-inflating core (12) having a non-inflated state and an inflated state and a coating (14) surrounding said core (12), wherein said core (12) comprises two or more segments (16) of dried compacted material of height H joined to each other by conformable linking portions (18) of height h where H is greater than h. the conformable linking portions (18) allow for the expander (10) to be conformed to a desired profile either before or after insertion under the skin of a patient.

Abstract: Systems and methods for delivering a gaseous contrast agent to the lungs of a subject.

Abstract: The invention relates to applicators for applying a solution or other composition (e.g., an antiseptic composition) to skin of a patient. The applicator may include a container body having a proximal end, a distal end, and a frangible member disposed at the distal end of the body. The applicator includes a first position where the container body and frangible member are a unitary piece (e.g., blow molded as a single piece), and a second position when the frangible member is rotated relative to the body to irreversibly break a weak point therebetween, releasing the composition in the hollow body through an opening. A porous applicator head may be positioned adjacent the distal end of the body and frangible member, so that the composition flows out the body, through the opening, and onto the head. The applicator may be formed in a blow-fill-seal process for improved sterility and ease of manufacture.

Abstract: An in-situ material delivery device for handheld, stereotactic table or MRI stage use may comprise a work element configured to selectively open and close at least one articulable beak configured to penetrate tissue to a target delivery site, or follow a central lumen of another device or other guiding modality, and then to deliver selected materials. Such a device may deliver a variety of materials such as markers, radio-active pellets, medications, other devices, and other materials of solid, liquid or gaseous form to a target site, and materials of similar nature may also be captured and removed from a target site. A single tube with or without coatings or an inner sheath and an outer sheath which may be co-axially disposed relative to a work element may be configured to actuate a beak or beaks and internal delivery mechanisms simultaneously. One embodiment of this device may be applicable to field use or one time use.

Abstract: The present invention is directed to linear surgical staplers for joining tissue layers comprising a disposable cartridge installed in a first jaw connected to an opposing second jaw, said cartridge containing a plurality of deployable staples in arrays separated by a tissue resection slot and a plurality of resorbable medicant-releasing microneedles, said microneedles comprising elongated rods having a sharp tissue-penetrating distal end and a proximal end; said microneedles are releasably disposed on or within a tissue-facing surface of the cartridge, wherein the proximal end of the microneedles is supported on the cartridge. The present invention is also directed to methods of use of such stapler assembly devices.

Abstract: A method for treatment of hyperproliferative tissue by injection of and subsequently exposing the hyperproliferative tissue to a frequency of ultrasound. The invention further includes purified bis [1-[6,7-bis [2-(sodium carbonate ethyl]-1,3,5,8,-tetramethyl-2-vinyl-porphin-4-yl]ethyl]ether (DVDMS) for use in sonodynamic treatment of hyperproliferative tissue including cancer and further includes a kit including a dosage controllable injection device charged with a biologically compatible fluid containing DVDMS.

Abstract: The present invention is a hemostatic plug for use with Extracorporeal Membrane Oxygenation (ECMO) cannulas that allow quick access to the blood vessel as well as maintaining a sterile environment to resume ECMO, if needed. It is designed to be a universal fit for use with adult ECMO circuits. The plug consists of a hemostatic membrane, a collection chamber and a cap. The membrane is designed to allow catheter delivery of up to a 19 French diameter through the ECMO cannula. The collection chamber allows the distribution of blood pressure over a broader surface, which allows additional hemostasis in addition to the membranes. The plug is then further reinforced with a cap that provides additional hemostasis, but when removed, allows hemostatic access into the blood vessel via the ECMO cannula.

Abstract: The invention relates to an apparatus for application of a pulsed radio frequency therapy in a vascular system or another cavity or tissue of the human or animal body comprising a catheter with at least one electrode disposed thereon for insertion into the vascular system or another cavity or the tissue of the human or animal body; a probe with at least one further electrode disposed thereon, wherein the probe is insertable via the catheter into the vascular system or the other cavity or the tissue of the human or animal body; and a generator electrically connected with the electrodes for generating a pulsed electro-magnetic field between the electrodes.

Abstract: Apparatus for neuromuscular electrical stimulation and methods for anchoring the same are provided. The apparatus may include an elongated member having one or more electrodes disposed at the distal region of the elongated member and at least one fixation element disposed at the distal region of the elongated member. The fixation element may be shaped and sized to be deployed between tissue layers, such as muscle layers, without damaging the tissue layers so as to secure the one or more electrodes in or adjacent to a desired anatomical site within a patient. An additional fixation element may be disposed at the distal region of the elongated member so that tissue, such as a muscle, may be sandwiched between the fixation elements without damaging the tissue.

Abstract: An implantable medical assist device includes a medical device. The medical device has a housing and electronics contained therein. A lead provides an electrical path to or from the electronics within the medical device. A resonance tuning module is located in the housing and is connected to the lead. The resonance tuning module includes a control circuit for determining a resonant frequency of the implantable medical assist device and an adjustable impedance circuit to change the combined resonant frequency of the medical device and lead.

Abstract: A surrogate implantable medical device includes a thermally conductive and electrically conductive housing. A header connector block includes a header block body, where the header block body is attached to the housing. At least one connector cavity is located within the header block body and configured to be attachable to an implantable lead. At least one conductive leadwire is disposed at least partially within the header block body having a first end and a second end. The at least one conductive leadwire's first end is electrically connected to the at least one connector cavity and the at least one conductive leadwire's second end is electrically connected to the housing. The housing does not contain active electronics.

Abstract: A device and method verifies the electrical output of a microcurrent therapy device. The current and/or voltage of an electrical pulse, being supplied to an electrode adapted to contact tissue, is measured by a control unit. The current and/or voltage is supplied by the control unit according to a predefined waveform. Any difference in the current or voltage of the electrical pulse being supplied with respect to the current or voltage of the predefined waveform is detected.

Abstract: System for generating a distally traveling synthetic esophageal motion within a subject's esophagus. Includes: elongated member sized and configured for nasal or oral placement into the esophagus; series of stimulators mounted/mountable on and distributed along a length of elongated member, for stimulating portions along an esophageal length spanning between esophagus LES and UES, and include at least two longitudinally spaced electrodes, chargeable to opposite polarities; and signal generator for generating and sending sequences of stimulating signals to stimulators, to evoke a plurality of local esophageal contractions as distally traveling synthetic esophageal motion along the esophageal length. Also disclosed is an implant suitable for use in generating a distally traveling synthetic esophageal motion within a subject's esophagus, for example, suitable for use in the disclosed system.

Abstract: A means for treating breathing disorders by stimulating respiratory muscles or nerves to entrain respiratory systems while leaving respiratory drive intact. Embodiments of the invention employ frequency analysis to determine if appropriate stimulation energy is being applied.

Abstract: Presented herein are excitation modeling and matching sound coding techniques that are configured to account for a recipient's estimated or predetermined neural response so as to improve a recipient's ability to perceive sound. More specifically, the techniques presented herein correlate a modeled excitation pattern with a target excitation pattern to generate a pattern of stimulation current configured to evoke an excitation pattern within the recipient's auditory system that approximates the target excitation pattern.

Abstract: A device including a cochlear implant electrode array and an apparatus configured to sense a phenomenon of fluid in a cochlea, wherein the apparatus and the electrode array are a single unit.

Abstract: Arrangements are described for assessing potential fitting processes for a cochlear implant patient. A test stimulation sequence at a given test frequency is delivered to the cochlear implant patient. The test stimulation sequence includes jittered stimulation periods when the test frequency varies due to a jitter variation component, and unjittered stimulation periods when the test frequency is constant without a jitter variation component. At least two different responses of the cochlear implant to the test stimulation sequence are measured in parallel. The different responses include an objective electrophysiological response, and a subjective psychophysical response. A correlation between the different responses is evaluated to determine an appropriate fitting process for the cochlear implant patient.

Abstract: A system and method for performing deep brain stimulation (DBS) therapy are provided. The method and system include pre-operatively acquiring at least one pre-operative image of the brain with at least one imaging sub-system and determining a location of a Nucleus Basalis of Meynert (NBM) for therapy in the at least one pre-operative image, and intra-operatively acquiring at least one intra-operative image of the brain after obtaining an access opening through the skull. The method and system further provide performing surgical planning based on the pre-operative image in the intra-operative image, advancing a lead having DBS electrodes on the lead to a target position proximate to or within the NBM area, and coupling the lead to an implantable pulse generator (IPG) configured to deliver DBS pulses through the DBS electrodes to the NBM. Further, the IPG is configured to deliver DBS pulses for treating symptoms associated with Alzheimer's disease.

Abstract: Multi-modal stimulation therapy may be utilized in which two or more stimulation therapies having different stimulation parameters may be delivered to a single patient. This can preferentially stimulate different nerve fiber types and drive different functional responses in the target organs. The stimulation parameters that may vary between the different stimulation therapies include, for example, pulse frequency, pulse width, pulse amplitude, and duty cycle.

Abstract: A medical device system is configured to sense a physiological signal by a first device and generate a control signal by the first device in response to the physiological signal. An optical transducer is controlled by the first device to emit an optical trigger signal in response to the control signal. A second device receives the optical trigger signal and delivers an automatic therapy to a patient in response to detecting the optical trigger signal.

Abstract: An implantable medical device system operates in an atrial synchronized ventricular pacing mode and switches to an atrial-asynchronous pacing mode when pacing mode switching criteria are met. A control circuit of the system detects a cycle length change between two atrial cycle lengths determined from a cardiac signal that includes far-field atrial events. If the cycle length change is greater than a change, threshold the control circuit determines if the pacing mode switching criteria are satisfied subsequent to detecting the cycle length change.

Abstract: A method includes a method implemented in a medical apparatus implanted in an animal and configured to at least one of transmit or receive a communication externally of the animal. The method includes receiving a communication. The method also includes detecting an indication of a malware in the received communication. The method further includes implementing in the implanted medical device a countermeasure responsive to the detected indication of malware in the received communication.

Abstract: One aspect generally relates to a composite, having a layer sequence. The layer sequence includes as layers a first layer, including a first ceramic, and first layer surface, a second layer, including a second ceramic, superimposing the first layer surface. The layer sequence includes a hole, connecting through each layer of the layer sequence; and a cermet. The cermet includes a first part and a second part. The first part is included by the hole. The second part is included between the first layer and the second layer. The cermet is in one piece.

Abstract: A cardiac defibrillator comprises electrical wires or terminals (24) connected with or configured to connect with defibrillation electrode pads (22), and an electrical circuit (32, 32a, 32b) including an electrical storage element (52) and a piezoelectric transformer (50) arranged to charge the electrical storage element to a voltage effective for delivering a cardiac defibrillation shock. The electrical circuit is configured to discharge the electrical storage element across the electrical wires or terminals to deliver a cardiac defibrillation shock to the electrical wires or terminals.

Abstract: Methods and apparatus are provided for applying low magnetic fields (<400 G) to mammalian cells, tissues and organs for protection from the damaging effects of ionizing radiation and other oxygen dependent injuries that involve the radical pair mechanism. The magnetic fields are generated by fixed magnets or active magnets and used to enhance the survival of healthy cells during radiation treatment for cancer, to protect workers from radiation within nuclear power plants, to protect astronauts from radiation during long space voyages, to increase working time in exposed environments, to provide a safe room in hazardous locations, and to protect normal tissue during radiation treatment and in medical imaging modalities that use ionizing radiation (X-ray, CT, mammography). The method described herein may also be used to mitigate the damaging effects of reperfusion, stroke, oxygen toxicity, inflammation, autoimmune disease, and the like by applying protective magnetic fields.

Abstract: Device and method for generating brief strong current pulses in a coil for generating magnetic field pulses which according to the electromagnetic induction principle induce stimulation currents in the body tissue triggering an action potential of the nerve and/or muscle cells, where the coil is positionable close to the body tissue to be stimulated so that its magnetic field passes through the body tissue, and where the device comprises a power generating unit that can generate a freely selectable temporal course of the current through the coil during the current pulse.

Abstract: One aspect of the present disclosure relates a system that can employ micromagnetic stimulation to activate and/or suppress conduction in at least a portion of a peripheral nerve. The system can include a stimulator to provide a time-varying stimulus. The system can also include a microcoil that can be operatively coupled to the stimulator to receive the time-varying stimulus. Based on the time-varying stimulus, the microcoil can provide an electromagnetic induction to the peripheral nerve to activate and/or suppress conduction.

Abstract: A system for sterilizing at least one surface of an object is provided. The system includes a set of ultraviolet radiation sources and a set of wave guiding structures configured to direct ultraviolet radiation having a set of target attributes to a desired location on at least one surface of the object. The set of wave guiding structures can include at least one ultraviolet reflective surface having an ultraviolet reflection coefficient of at least thirty percent. Furthermore, the system can include a computer system for operating the ultraviolet radiation sources to deliver a target dose of ultraviolet radiation to the at least one target surface of the object.

Abstract: Phototherapy systems comprising a therapeutic lamp platform for radiant lamps such as LEDs disposed in a holdable spot applicator assembly, the holdable spot applicator assembly including a reflective surface facing towards a patient and a plurality of LEDs for communicating lamp radiation from the lamps to a user. The lamps and associated circuitry are housed within a holdable elongated structure.

Abstract: A system (101) for treatment of an epithelial tissue layer (3) is provided. The system comprises a reservoir (107), for containing an amount of a flowable medium, arranged to enable the medium, when contained in the reservoir, to be in contact with a surface (5) of the epithelial tissue layer, a light source (109) for generating a laser beam (11) during at least a predetermined pulse time, and an optical system for focusing the laser beam into a focal spot (15), and for positioning the focal spot in a target position. The target position of the focal spot is within the reservoir and within the medium, when contained in the reservoir, and the dimension of the focal spot and the power of the generated laser beam are such that, in the focal spot, the laser beam has a power density, which is above the characteristic threshold value for the medium, above which, for the predetermined pulse time, a laser induced optical breakdown event occurs in the medium.

Abstract: Unactivated stem cells are activated by treating them with an amplitude modulated laser beam having a wavelength lying in the range of 405 to 980 nanometers. The laser beam is modulated within a range of 8 to 12 MHz. Using the activated stem cells, tissue can be repaired and regenerated by preparing the unactivated stem cells, treating the unactivated stem cells with an amplitude modulated laser beam having a pre-determined frequency for obtaining activated stem cells, administering the activated stem cells into a body containing the tissue, and using a homing beam to guide the activated stem cells within the body to the location of the tissue.

Abstract: A radiation emitting apparatus includes a radiation source to generate radiation, a first collimator to define a maximum radiation field of the radiation; a second collimator to regulate the radiation field and direction of irradiation; a swing portion that swings in two directions orthogonal to each other; a displacement detector to detect displacement of the second collimator relative to a reference point; a drive mechanism to drive the swing portion; a control unit to control the drive mechanism; and a storage unit included in the control unit to store one or more parameters related to mechanical movement of the swing portion. The control unit generates feedforward control information based on an inputted target swing angle, a detected displacement, and the one or more parameters stored in the storage unit, and outputs a drive signal containing the feedforward control information to the drive mechanism.