Abstract: An inhalation device includes a light source that emits light, a light sensor that senses an intensity of the light emitted from the light source and a processor or circuit configured to perform a metering process. The metering process may include when a signal indicating that a puff has been detected by the puff detecting element: extracting a predetermined known flow rate that is stored in the memory in advance, determining an amount of vaporized substance that have been produced, and accumulating the determined amount of vaporized substance that has been produced in the memory as a total amount produced. The metering method may also include when the accumulated total amount produced reaches a predetermined threshold: (i) shut off the heating element or (ii) send a signal to an indicator that the predetermined threshold amount of the vaporized substance has been consumed.

Abstract: An inhaler device configured to consume an accumulated capacity to contribute to generation of aerosol or aerosol imparted with flavor, a sensor configured to detect a predefined variable, an interface configured to make a notification to an inhaler of the aerosol, and a controller configured to cause the interface to function in a first mode when a detected or estimated capacity is smaller than a threshold and the variable satisfies a predefined condition for requesting the generation of the aerosol.

Abstract: An inhaler device configured to consume an accumulated capacity to contribute to generation of aerosol or aerosol imparted with flavor, a sensor configured to detect a predefined variable, an interface configured to make a notification to an inhaler of the aerosol, and a controller configured to cause the interface to function in a first mode when a detected or estimated capacity is smaller than a threshold and the variable satisfies a predefined condition for requesting the generation of the aerosol.

Abstract: A valve assembly attached to a capacitor such that pressurizing the capacitor to a first positive pressure threshold induces the valve assembly to open, the pressurized air is released to the patient, and then as the pressure in the capacitor drops to a second pressure threshold the valve closes and the capacitor begins to build pressure until the first positive pressure threshold is achieved and the process repeats. Relative to the valve assembly and integrated therein, is an incrementally adjustable index knob to vary the rate of a biasing force performing work against the actionable valve face of the diaphragm functional surface to set the performance of the valve assembly, thereby increasing the potential for correct operation across a range of oscillating rates supporting a broad spectrum of patient therapies and types.

Abstract: An interface for positive pressure therapy includes a mask assembly, a headgear assembly and a connection port assembly. The mask assembly comprises a seal member that has an upper portion movably connected to an integrated lower portion, wherein the upper portion rolls during hinging movement of the upper portion relative to the lower portion. The headgear assembly allows connection to the mask assembly in a direction substantially normal to a direction of strap tension. The connection port assembly includes a swivel elbow with a valve member that controls flow through a port that opens toward the user.

Abstract: A sedation device (1) comprises a housing (2) having a ventilator chamber (3) and an associated patient chamber (4) in communication with the ventilator chamber (3). A filter (5) is mounted between the ventilator chamber (3) and the patient chamber (4) and forms a common gas-permeable dividing wall between the ventilator chamber (3) and the patient chamber (4). An inlet port (6) is provided on the ventilator chamber (3) for connection via a Y-piece to a ventilator. An outlet port (9) of the patient chamber (4) connects via a patient breathing tube (10) with a patient. Means for varying the internal volume of the housing (2) comprises an associated pair of inserts, namely a first insert (14) fixedly mounted in the ventilator chamber (3) and a second insert (15) fixedly mounted in the patient chamber (4). One or both of these inserts (14, 15) are mounted within the housing (2) to vary the internal volume of the housing (2) as required to suit different patients.

Abstract: An endotracheal tube is provided having flexible tubing of a predetermined inner diameter and a predetermined length adapted for endotracheal intubation via a mouth or nasal passage of a patient and a separate curve stabilizer to which the flexible tubing may be attached and through which the flexible tubing extends. The curve stabilizer includes walls forming a hollow elbow which has distal and proximal ends and a curved section therebetween and being sufficiently rigid to retain a portion of the flexible tubing in a curved shape forming an anti-kink bend at any selected location along the predetermined length of the flexible tubing. A curve stabilizing device and a method of endotracheal intubation are also disclosed.

Abstract: An nCPAP device for assisting patient breathing includes a generator body forming an inlet, a chamber, and first and second flow circuits. The chamber directs pressurized gas from the inlet to the flow circuits. The flow circuits each include a nozzle, a channel, and at least one port. The nozzle emits a jet stream into the channel in a direction of a patient side thereof. The port fluidly connects the channel to ambient, and promotes entrainment of ambient air with the jet stream. In some embodiments, the channel forms a ramp feature directing exhaled air toward the jet stream in an angular fashion. The generator body requires reduced driving pressures to achieve target CPAP levels and reduces total imposed WOB as compared to conventional designs.

Abstract: A respiratory apparatus may employ ultrasonic welds. The ultrasonic welding may be used to join a variety of headgear, mask and accessory components. This process may enhance comfort, fit and/or performance of the joined components and/or overall mask assembly. A component may be a single layer component such as a textile or fabric, or a composite or multiple layer component such as fabric and foam composites, or outer fabric layers and inner spacer fabrics. Further, a component may be a strap, some other headgear component, a mask component, an accessory component or the like.

Abstract: A respiratory assembly is provided. The assembly includes at least one post having a nasal engaging portion on about a first end thereof for delivering treatment gases to the nasal cavity of a patient. A pair of tubes capable of receiving gas from a hose or fluid source are selectively engaged with the pair of posts for delivering treatment gases from the inlet through the receptacle and into the nasal cavity of the patient. A splitter may be positioned between the hose or fluid source and the pair of tubes. Ball and socket joints may provide enhanced flexibility of the assembly while in use.

Abstract: A vaporizer configured in such a way that integrates a user removable and replaceable filtering system in which vapor, aerosols, smoke, and or odors are reduced or eliminated upon use of the filtering system should the user wish to use it. The vaporizer may also integrate in some forms a valve system which restricts or eliminates the flow of air into or out of the device in order to mitigate and or eliminate the escape of smoke, aerosols, vapor, and or odor; of which a user may activate via electrical or mechanical means. The vaporizer integrates logic and control circuitry which controls the power displaced into an integrated or removable heating chamber, atomizer, cartomizer, cartridge, clearomizer and or any other such container in which materials or substances are vaporized or combusted. The logic and control circuitry also employs user input through various means, such as a electromechanical switches and or an accelerometer.

Abstract: An inhalator (1) comprising a first compartment (21) containing an active compound; a second chamber (31) containing a transporter and an activation part (40) configured for regulating an air flow through the inhalator (1), and arranged at a distal end the second compartment (31), characterized in that the first compartment (21) is arranged between a user interface part (10) and the second compartment (31) such that when a user sucks air through the inhalator (1), the transporter is drawn from the second compartment (31) through the first compartment (21), whereby the active compound is captured by the transporter and flows into the user interface part (10) and the user.

Abstract: A humidifier includes a heating element including a porous structure of electrically resistive and thermally conductive material configured to substantially vaporise liquid that is passed through the porous structure. The porous structure has a liquid inlet and a vapour outlet. The humidifier further includes an outer housing surrounding at least a portion of the porous structure for containing the liquid and vapour within the porous structure. The porous structure includes a first electrical connector and a second electrical connector, the first and second connectors being configured for receiving electrical power and applying a voltage across the porous structure to generate heat.

Abstract: A positive airway pressure (PAP) device for supplying a flow of breathable gas to a patient includes a flow generator configured to pressurize a flow of breathable gas and a humidifier configured to receive and humidify the pressurized flow of breathable gas from the flow generator. The PAP device also includes a power source. The flow generator, humidifier and power source are positioned so that heat generated by at least one of the flow generator and the power source is conveyed to water in the humidifier.

Abstract: A respiratory treatment device having an inlet configured to receive exhaled air into the device and an outlet configured to permit exhaled air to exit the device. A blocking member is moveable between a closed position where the flow of air through the device is restricted, and an open position where the flow of air through the device is less restricted. A biasing member is configured to bias the blocking member toward the closed position, wherein a level of bias decreases as the blocking member moves from the closed position to the open position.

Abstract: An infant calming/sleep-aid device that includes a moving platform and a sound generator, the sound and motion adapted to calm a fussy baby, induce sleep, and maintain sleep under normal conditions. The device makes a determination as to whether sound signals represent sound coming from inside the device or outside the device. If the sound signals are coming from the inside the device, then the signals are evaluated in a specified frequency band to determine whether the sound is a baby cry. If a determination is made that there is a baby cry, then a threshold analysis is performed to quantify the cry and compare it to a threshold value. If the cry is above a specified threshold, the device moves the platform and/or generates sound.

Abstract: A compact packaged intermittent urinary catheter having a longitudinally elongated intermittent urinary catheter retained within a longitudinally compacted elastic package. A method of using the catheter wherein at least a portion of the package is used as a drainage tube for the catheter. A package for an intermittent urinary catheter including a longitudinally compacted elastic package having a longitudinally extending receiving chamber containing a lubricating medium. The package having two longitudinal ends that may be removed to open the package and enable conversion of the package from a compacted state to an extended state. A method of using the package as a clean handling sleeve through which an intermittent urinary catheter may be passed to coat it with a lubricating medium.

Abstract: Ureteral catheters and assemblies are provided including: a drainage lumen including a proximal portion configured to be positioned in at least a portion of a patient's urethra and a distal portion configured to be positioned in a patient's ureter and/or kidney, the distal portion including a coiled retention portion including at least a first coil having a first diameter and a second coil having a second diameter, the first diameter being less than the second diameter; or wherein the retention portion extends radially outwardly from a portion of the distal end of the drainage lumen portion, the retention portion including a proximal end having a first diameter, a distal end having a second diameter, and a wall and/or surface extending therebetween, the retention portion having a second diameter is greater than the first diameter when deployed; or wherein the retention portion includes a plurality of drainage tubes.

Abstract: An example introducer and method of use is disclosed. The example introducer sheath includes a shaft including a tubular portion, an expandable portion coupled to the tubular portion and a longitudinal axis. Additionally, the expandable portion includes a first pair of leaflets and a second pair of leaflets and both the first pair of leaflets and the second pair of leaflets extend along the longitudinal axis. Additionally, the second pair of leaflets are spaced radially inward of an inner surface of the first pair of leaflets and the expandable portion is designed to shift between a first configuration and a second expanded configuration.

Abstract: A drainage or infusion catheter and methods of use are disclosed. In one embodiment, the catheter includes a tube body having a proximal end and a distal end, and a plurality of ports arranged along the tube body from the distal end to the proximal end. The distal end of the tube body is configured to deform around itself into a substantially spiral shape so as to cover at least one of the plurality of ports located near the proximal end of the tube body. In another embodiment, a flap is configured to erupt from apertures arranged in the tube and extend outwardly around the tube body so as to cover at least one of the plurality of ports located near the proximal end of the tube body.

Abstract: A method of manufacturing a catheter assembly including a proximal catheter assembly portion and a distal catheter assembly portion. The method of manufacturing comprises forming the proximal catheter assembly portion, creating a distal catheter assembly portion, and applying a polymeric coating to at least one of the proximal catheter assembly portion and the distal catheter assembly portion. The proximal catheter assembly portion can include a catheter hub and at least one cannula, the catheter hub including at least one fluid passageway in communication with a lumen of the at least one cannula. The distal catheter assembly portion can include a catheter tube defining at least one lumen designed to receive the at least one cannula. The polymeric coating is configured to provide a seal between the at least one cannula and the catheter tube when the proximal catheter assembly portion and the distal catheter assembly portion are connected.

Abstract: A kit including a sheath having a tubular body with proximal and distal ends, an axis extending between the ends and a wall defining a bore extending along the axis to the distal end of the body. A delivery tube having proximal and distal ends and a lumen is adapted for disposition within the bore of the sheath in sealing engagement with the sheath, the delivery tube being slideable distally relative to the sheath. An elongated cannula having proximal and distal ends and a lumen is adapted for disposition inside the lumen of the delivery tube and an elongated dilator is adapted to fit within the lumen of the cannula with a proximal portion of the dilator extending proximally beyond the proximal ends of the cannula and delivery tube and in sealing engagement with the delivery tube proximal to the cannula.

Abstract: A medical system is provided. The medical system includes a guidewire configured to guide a catheter to a target location within a body, the guidewire including a sensor configured to collect sensor data indicative of a location within the body, and an electrical conductor configured to conduct electrical signals representing the sensor data. The medical system further includes a wireless transmitter and a first antenna electrically coupled with the sensor via the electrical conductor and configured to: receive the electrical signals representing the sensor data; generate, from the electrical signals, first wireless signals representing the sensor data; and transmit, via the first antenna, first wireless signals.

Abstract: Guide extension catheters and related methods are disclosed. A guide extension catheter can comprise an elongate tube member, a push member, and a concave track. The elongate tube member can define a lumen and three distinct portions of different diameter. A distal portion can define a first diameter, a proximal portion can define a second diameter which is larger than the first diameter but smaller than a lumen of a guide catheter with which the guide extension catheter is used, and a tapered portion, positioned between the distal portion and the proximal portion, can have a variable diameter. The push member can be eccentrically coupled relative to the tube member and extends proximally therefrom for slidably positioning the tube member within and partially beyond a distal end of the guide catheter. The concave track forms a transition between the tube member and the push member, and defines a partially cylindrical opening leading into the tube member.

Abstract: Described herein are bend-limited catheters (e.g., apparatuses, including devices and systems) and methods of using them.

Abstract: Described herein are methods of using bend-limited catheters that are freely bendable at angles greater than the locking bend angle, e.g., when the bend radius is less than the locking bend radius. The device will limit or prevent bending beyond the locking bend angle.

Abstract: Described herein are bend-limited catheters (e.g., apparatuses, including devices and systems) and methods of using them. These apparatuses may include an elongate tubular body that has one or more cut-out kerfs forming a pattern of interlocking teeth that are arranged in rings (and/or one or more spiral patterns) around the perimeter of the elongate tubular body. The pattern of interlocking teeth is configured to provide the catheter with a high degree of flexibility in bending, while permitting the device to lock at a locking diameter when the catheter bends to a minimum locking angle, beyond which no further bending is permitted.

Abstract: A device for sealing and securing a catheter at its insertion site in order to provide for optimum safe catheter function, and to achieve maximum catheter longevity/dwell time is described. The sterile seal achieved by this device fully protects the catheter and its insertion site from external contamination. The unique sterile seal also functions to fully stabilize and secure the catheter, thereby minimizing traumatic catheter injury and loss. A means of continuously viewing the insertion site is also provided, as well as mechanisms for maintaining sterility of the sterile chamber that is formed around the catheter insertion site by the integrated sealing and securing device. Together these features allow for improved catheter safety and function, and allow catheters to safely remain in place for an extended period of time. The need to change catheter dressings at intervals is minimized or eliminated.

Abstract: A system for strain relieving intravenous (IV) assembly includes a dressing and an anchor portion for use with the dressing. In various embodiments, the dressing may cover an injection site into a portion of a patient's body for an intravenous (IV) assembly that provides fluid communication between the injection site and a fluid reservoir remote from the injection site through a flexible tube. In an illustrative example, the anchor portion may include a first member and a second member. The first member may be secured, for example, to the dressing and may, in some examples, wrap around the tubing so as to resist axial movement of the tubing relative to the dressing. The second member may be secured to the dressing and may wrap around the tubing and a portion of the patient's body so as to resist radial movement of the tubing relative to the body.

Abstract: A securement device for securing medical devices. The securement device includes a body member and is configured to conform to a patient when adhered to the patient. The body member can include a first surface and a second surface opposite the first surface, the first surface including an adhesive thereon. One or more pads can be positioned on the first surface of the body member, and a channel can be included in at least one pad of the one or more pads, between at least two pads of the one or more pads, or formed when a medical device is pressed into the one or more pads. The securement device can mitigate lateral and longitudinal motion of the medical device when the medical device is disposed in the channel.

Abstract: A catheter assembly includes a catheter, a catheter hub fixed to the proximal end portion of the catheter, a hollow inner needle removably located in the catheter and including a distal end portion at which is located a needlepoint to puncture skin of a patient, and a guide wire slidably positioned in the inner needle. The guide wire is longer than both the inner needle and the catheter. A wire operating member is connected to the guide wire and is displaceable in the forward direction relative to the inner needle and the catheter. A main body is detachably connected to the catheter hub and includes a finger-engaging projection at a distal portion of the main body that is engageable by a user's finger to advance the main body and the catheter in the forward direction. The wire operating member is superimposed on the main body.

Abstract: An introducer sheath for the insertion of a medical device into a blood vessel having an expandable sheath. The sheath has a length, a thickness, and proximal and distal ends. The expandable sheath has a frame extending longitudinally between the proximal end and the distal end, and having an exterior surface and an interior surface that forms an interior lumen along the length of the frame. The frame is configured to achieve an expanded state and a contracted state, the expanded state forming an expanded cross-section in the lumen for passing a medical device therethrough. The frame has a smooth coating about the exterior surface and protrusions extending into the lumen along the interior surface. The introducer sheath can be introduced into a patient in the contracted state, with the distal end of the introducer sheath prevented from moving in the proximal direction by an abutment against a dilator end surface.

Abstract: Devices and methods for the treatment of chronic total occlusions are provided. One disclosed embodiment comprises a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The method includes providing an intravascular device having a distal portion with a lumen extending therein; inserting the device into the vascular lumen; positioning the distal portion in the vascular wall; and directing the distal portion within the vascular wall.

Abstract: The disclosure provides a system and method for a programmable medical wire that can be preprogrammed, and controlled and reshaped upon command. The system can include a power supply, a controller, and a multilayered wire assembly. The wire assembly includes a core conductor, actuator conductors coupled to the core conductor, selective conductors formed adjacent the core conductor and the actuator conductors, and a protective biocompatible shield around the layers. The selective conductors can be energized to activate the actuator conductors and cause the actuator conductors to bend or twist in a preprogrammed manner. By selectively controlling the direction of movement of the actuator conductors, the wire assembly can be remotely guided through body passageways to the target. Auxiliary equipment such as sensors, micro cameras, detectors, cutters, and other equipment can also be coupled to the wire assembly, and controlled and communicated with through one or more of the selective conductors.

Abstract: Balloon catheters for, and related methods of, preventing contrast-associated nephropathy are disclosed. A method for preventing contrast-associated nephropathy can include inserting a catheter into a patient's coronary sinus and blocking blood flow from the coronary sinus into the patient's right atrium. The blood may contain a contrast agent. The method can further include draining the blood from the coronary sinus through a first lumen defined by the catheter while the blood flow is blocked, filtering the contrast agent from the blood which passes through the catheter, and returning contrast-free or contrast-reduced blood to the right atrium through a second lumen defined by the catheter, which terminates in a port proximal to the coronary sinus. Another method can include selectively draining blood from the coronary sinus into the right atrium through a first lumen defined by a catheter that includes a switchable valve while the blood flow is blocked.

Abstract: Expandable intubation assemblies and methods for using and making the same are provided.

Abstract: A device is provided for delivery of a therapeutic agent to the anal and perianal regions. The device includes a deployable internal anchor adapted to comfortably anchor the device in the anal canal, a shaft adapted to store and release the agent to the anal canal, and an external bumper adapted to store and release the agent to the perianal tissue and externally anchor the device.

Abstract: A remotely activatable capsule. The capsule includes a housing that can be swallowed by a subject, an electrical energy reservoir having a first terminal and a second terminal positioned in the housing, a remotely activatable switch positioned in the housing and configured to be remotely activated, and a function-specific mechanism positioned in the housing and electrically coupled to the remotely activatable switch and to the electrical energy reservoir and configured to perform a function when the remotely activatable switch is activated.

Abstract: Apparatus and methods to treat skin defects include a pump with reservoirs for a pressurization gas and a fluid. Upon activation, the pump generates a gas introduced into the gas reservoir, a movable wall of which displaces a movable wall of a fluid source, thus dispensing the fluid into the dressing to spread throughout irrespective of orientation of the dressing, maintaining a transport fluid (e.g. carrier) in the dressing and in contact with a skin defect being treated. The dressing may have a distribution network, and multiple members, dispensing the fluid into the dressing and in contact with a skin defect being treated.

Abstract: An applicator includes: a liquid medicine container having an opening, and a brush member arranged adjacently to the liquid medicine container to cover the opening. The brush member is made up of a plurality of fibers that are bundled together. The brush member has a tubular shape in a root portion located adjacently to the liquid medicine container, tapers from the root portion toward a top end portion located opposite to the liquid medicine container, and has a wedge shape in the top end portion.

Abstract: A soft tip applicator with flexible tendrils attaches to a syringe for spreading expressed liquid from the syringe onto a surface, such as skin. A detachable microneedle assembly supports microneedling treatment of the skin as the liquid is expressed.

Abstract: A multi-site injection system includes a plurality of medicament delivering needles/microprotrusions, a needle/microprotrusion support, a supply of medicament, and a mechanism for providing the medicament to the plurality of needles/microprotrusions in order to effect delivery into a stratum corneum of a user.

Abstract: A delivery system for delivering a drug depot to a site within a patient, the system comprising: a cannula; a delivery stylet configured and dimensioned to be receivable by and slidable forwardly and backwardly within the cannula including to a position wherein a distal portion of the stylet protrudes beyond the distal end of the cannula; a drug depot retainable by the stylet at the distal end of the stylet, the drug depot being visualizable by a diagnostic imaging beam or modality; and an actuator for ejecting the drug depot from the stylet to a site within the body using fluid pressure. Also disclosed are methods using, and uses of, the delivery system, including for treating scoliosis.

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: A venous access port assembly having a housing base with a discharge port, a septum, and a cap, with an interior reservoir. The housing base is provided with X-ray discernable indicia to identify an attribute of the assembly after its implantation and clearly appear on an X-ray of the patient in a manner informing the radiologist or technologist and the medical practitioner of that particular attribute. Such indicia can be depicted as cutouts through a disc of radiopaque material where the cutouts are in the form of alphabetical letters such as “CT”, or can be a set of discrete elements of radiopaque material, that are affixed along the bottom surface of the housing base or embedded within the thickness of the bottom housing wall.

Abstract: A luer connection device is disclosed having a housing including a side wall having an inside surface defining a lumen with a central axis, an proximal end, and a distal end including a male luer tip within the lumen having a central flow diverter extending outwardly from the central axis to direct a fluid to a circumferential dead space distal to the male luer tip. A luer connection device is also disclosed having a flow expansion channel disposed in the lumen tapering outward from the wall of tubular housing and partially extending along a longitudinal axis from the tip opening toward the base opening for increasing mixing and flow through a circumferential dead space in the fluid path distal to the male luer tip.

Abstract: A catheter system may include a luer adapter, which may include an outer surface having threading or a recess. The catheter system may also include a flow control plug, which may include a proximal end and a distal end. The proximal end of the flow control plug may include a filter element permeable to air and not to blood. The distal end of the flow control plug may include a cylinder and a taper-shaped luer tip spaced apart from the cylinder. An inner surface of the cylinder may include a protrusion engaged in a snap-fit with the recess or corresponding threading mated with the threading.

Abstract: An infusion coupling allows administration of IV drugs to a patient through an IV fluid line, and ensures that successive courses of medication are fully passed or flushed from the line to prevent mixing of incompatible drugs in the IV line. The infusion coupling includes a vessel body, and a plurality of branch inlets to receive medication through IV tubing connected to the inlets. The vessel body a generally cylindrical shape such that each of the branch inlets is in fluidic communication with the interior volume for receiving the IV fluids for transport. The inlets are angled on the body of the infusion coupling. A transverse bar or obstruction extends across an interior diameter of the infusion coupling for disrupting a circular flow that can result in a vortex. Formation of a vortex can retain the infused medication in the infusion coupling and result in mixing with successive medication courses.

Abstract: A frangible connector has a first side that forms a female luer when a second side is fractured at a predefined break line. The second side may be connected to a fluid circuit, for example, a source of medical treatment fluid such as dialysate.

Abstract: Methods for fabricating implantable cuff electrodes for contacting or at least partially surrounding internal body tissue such as, e.g., nerves, smooth muscles, striated muscles, arteries, veins, ligamental tissues, connective tissues, cartilage tissues, bones, or other similar body tissues, structures and organs are disclosed. An example method includes preparing a substrate including an implantable cuff electrode shape, applying a mold material to the substrate, curing the mold material to form a mold, releasing the mold from the substrate, inserting at least one conductor into the mold that penetrates through the channel of the mold, pressing a formable material into the channel of the mold to form a body of an implantable cuff electrode about the at least one conductor, curing the body of the implantable cuff electrode, and releasing the body of the implantable cuff electrode from the mold.