Abstract: A face mask for extended wear by a user including a customized, contoured facial mask portion constructed and configured to cover and matingly contact a corresponding contoured surface area of a human face, preferably formed by 3D printing methods and materials.

Abstract: A respiratory apparatus for delivering breathable gas to a patient includes a flow generator that generates a supply of pressurised gas to be delivered to the patient; a humidifier for vaporising water and delivering water vapor to humidify the gas; a gas flow path leading from the flow generator to the humidifier and from the humidifier to a patient interface; and a heater in thermal contact with the gas and/or the water, wherein the heater comprises an elongate heating filament in the form of a tape. A humidifier for respiratory apparatus includes a first respiratory gas passage for receiving gas from a flow generator, a humidifier chamber, a second respiratory gas passage for delivering humidified gas to a patient interface, and a heater in thermal contact with the gas and/or the water, wherein the heater comprises an elongate heating filament extending along at least part of both said first and second respiratory gas passages.

Abstract: A healthy gas generating system for generating healthy gas for inhalation by a user includes an electrolysis device, a gas mixing device, and a backfire barrier. The electrolysis device electrolyzes water to generate a gas with hydrogen. The gas mixing device includes a mixer and a vibrator for mixing the combination gas with an atomized gas to produce the healthy gas. The backfire barrier is configured on the output of the gas mixing device or the gas passage of receiving the combination gas to avoid the backflow of the gas.

Abstract: A respiratory mask arrangement that can be used in the framework of CPAP therapy for treating sleep-related disturbances, for example. The respiratory mask arrangement may include a sealing lip device to be placed on a facial surface of a mask user, a covering device which defines a mask interior in cooperation with the sealing lip device, and a respiratory gas conduit unit for delivering respiratory gas to the mask interior that is defined by the covering device and is connected to the nostril and/or oral opening of the mask user. At least some sections of the covering device may be embodied as an air-permeable structure.

Abstract: An air treatment device can include a pad having a front side and a back side that faces opposite the front side. An aromatic scent can be infused within the pad. Additionally, an adhesive layer can be disposed along the back side of the pad that can allow the pad to adhere to textile materials, such as pillow cases and clothing.

Abstract: The present disclosure provides a system and a method for relaxation and cultivation of attention. The method comprising: detecting a non-respiratory bodily action of a first person; determining based on comparing the non-respiratory bodily action of the first person with at least one predetermined threshold, whether or not the first person is voluntarily attending on the non-respiratory bodily action at the present time; and generating feedback to be perceived by the first person through at least one response system if the first person is voluntarily attending on the non-respiratory bodily action at the present time.

Abstract: A multilumen catheter shaft body includes a proximal end segment with a first durometer and a first longitudinal length dimension. A proximal intermediate segment is fixedly joined to a distal end of the proximal end segment and includes a second durometer and a second longitudinal length dimension. A distal intermediate segment is fixedly joined to a distal end of the proximal intermediate segment and includes a third durometer and a third longitudinal length dimension. A distal terminal end segment is fixedly joined to a distal end of the distal intermediate segment and includes a fourth durometer and a fourth longitudinal length dimension. The first durometer is greater than at least the second and third durometers. The fourth durometer is greater than at least the second and third durometers. A plurality of parallel longitudinal lumens extends through the body, providing a structure useful in a cholangioscope or other endoscopic applications.

Abstract: An intravascular device delivery system has an elongated member with a flexible hypotube. The hypotube can be rotationally keyed to a steerable catheter. The flexible hypotube includes one or more cuts to allow bending of the flexible hypotube within a first plane. The steerable catheter is steerable to bend the flexible hypotube within the first plane, and longitudinally movable relative to the flexible hypotube to allow distal movement of the steerable catheter relative to a distal end of the flexible hypotube.

Abstract: An insertion tool for inserting a catheter into a patient's body is disclosed. The insertion tool unifies needle insertion, guidewire advancement, and catheter insertion in a single device. In one embodiment, the insertion tool comprises a housing in which at least a portion of the catheter is initially disposed, a hollow needle distally extending from the housing with at least a portion of the catheter pre-disposed over the needle, and a guidewire pre-disposed within the needle. A guidewire advancement assembly is also included for selectively advancing the guidewire distally past a distal end of the needle in preparation for distal advancement of the catheter. In one embodiment a catheter advancement assembly is also included for selectively advancing the catheter into the patient. Each advancement assembly can include a slide or other actuator that enables a user to selectively advance the desired component. Guidewire and catheter locking systems are also disclosed.

Abstract: A robotic catheter procedure system includes a bedside system that has a percutaneous device, and an actuating mechanism configured to engage and to impart movement to the percutaneous device. The system also includes a workstation coupled to the bedside system. The workstation includes a user interface configured to receive a user input, ma display device configured to display an image, a control system operatively coupled to the user interface and the actuating mechanism. The control system is configured to generate a control signal and the actuating mechanism causes movement of the percutaneous device in response to the control signal. The control system is configured to slow movement of the percutaneous device via the actuating mechanism as an identified point on the percutaneous device approaches a structure requiring a change in direction of the percutaneous device.

Abstract: A method for controlling a magnetic catheter by using a magnetic-field-generated magnetic annulus is disclosed. The magnetic catheter has a free end provided with a magnetic member. A resultant magnetic field between at least two magnets generates a magnetic annulus. The magnetic catheter is placed into the magnetic annulus, so that the magnetic member is affected by the magnetic force from the magnetic annulus to guide the magnetic catheter to perform a preset motion. The magnetic catheter has a flexible front section, so that the flexible section can perform a bending motion when led by the magnetic member. The resultant magnetic field is generated by arranging the two magnets with their like poles facing each other, so that the magnetic member is thrust when entering the magnetic annulus. This facilitates the bending motion of the flexible section.

Abstract: A steerable-catheter handle includes an outer housing with a multilumen catheter body extending generally distally therefrom. An internal track, including at least one track-defining lateral edge element, is disposed between distal and proximal terminal ends of the outer housing, which also houses a manifold engaged with the catheter body, a working-channel port member in fluid and mechanical communication with at least a first catheter lumen, a vacuum channel port member in fluid communication with at least one catheter lumen via one or both of the working channel port member and the manifold, and a generally proximal catheter port open to the internal track, where a distal endmost portion of the catheter mechanically communicates with one or more control surfaces so that the distal endmost portion of the catheter is deflectable along at least two intersecting axes, and where a portion of the catheter body extends removably through the internal track.

Abstract: A secure attachment method and structure for a wire (including non-metallic fiber, yarn, cable, etc.) is provided within a steerable catheter that includes a proximal end, a distal end, and an intermediate catheter body length therebetween, with at least a first catheter lumen extending longitudinally through the catheter body, at least a first elongate wire disposed longitudinally through the first catheter lumen, and an adhesive substantially within, and securing the wire to, a dilated distalmost length of the first longitudinal lumen, where at least a lengthwise portion of the wire is frayed or otherwise at least partially disaggregated. The structure and method provides for robustly secure affixation that will allow steering/deflection control by manipulation of another portion of the wire.

Abstract: A spool and gear mechanism for tensioning and manipulating the steering/deflection control wires of a steerable catheter device provides for a desired level of tension that will allow operation of the device without too little or too much tension in those wires. In a wire-tensioning mechanism for a steerable catheter, the mechanism includes at least a first and second steering/deflection control wire each attached to the spool by winding around its own detent-engaged rotatable gear in the spool and extending out through a radial wall of the spool to engage into a steerable catheter body. In a multi-spool system, the wire-tensioning/winding gears of each spool preferably are accessible for adjustment via apertures of an adjacent spool.

Abstract: A secure attachment method and structure for a wire (including non-metallic fiber, yarn, cable, etc.) is provided within a steerable catheter that includes a proximal end, a distal end, and an intermediate catheter body length therebetween, with at least a first catheter lumen extending longitudinally through the catheter body, at least a first elongate wire disposed longitudinally through the first catheter lumen, and a first adhesive having a first viscosity, the first adhesive disposed substantially within, and securing the wire to, the first longitudinal catheter lumen, where at least a lengthwise portion of the wire is frayed or otherwise at least partially disaggregated. The structure and method provides for robustly secure affixation that will allow steering/deflection control by manipulation of another portion of the wire.

Abstract: A steerable catheter has a body with an outer surface and an inner surface defining a central lumen. The outer surface and inner surface define a wall of the body, which has a plurality of steering lumen and control lumen extending longitudinally therethrough. The body includes a body material. The steering lumen and control lumen have a control lumen lining and steering lumen lining, respectively, with a higher durometer than the body material. A steering wire is positioned within the steering lumen and a control wire is positioned within the control lumen.

Abstract: Intravenous access is achieved by introducing a catheter over an access needle which is initially present in the catheter. A tapered dilating element is positioned over the needle and provides a transition between the needle and a larger catheter lumen. The access needle is hollow and has a port which allows blood to flash back through a lumen of the catheter so that flashback can be observed on a catheter hub or the catheter itself.

Abstract: A catheter assembly comprises a collar assembly comprising a coupling portion proximate the second end and a first compression member configured to removably engage the coupling portion. The catheter assembly further comprises a wing assembly that includes a housing configured to at least partially receive a cannula. The wing assembly also comprises two or more wings extending radially from the housing and a second compression member configured to removably engage a coupling portion. A tube is configured to fluidly couple the collar assembly to the wing assembly, and wherein a portion of the tube is retained by the first and second compression members.

Abstract: The present invention provides a novel design for sheaths intended for medical procedures. The sheath includes structures that anchor the sheath in a cavity or space when deployed but are at the same time retractable such that the sheath can be removed without tearing the tissue defining the space.

Abstract: Balloon catheters, methods for preparing balloon catheters, and uses of balloon catheters are disclosed. The balloon catheter includes an elongate member, an expandable balloon, and a coating layer overlying an exterior surface of the expandable balloon. The coating layer includes a total drug load of a hydrophobic therapeutic agent and a combination of additives including a first additive and a second additive. The hydrophobic therapeutic agent is paclitaxel, rapamycin, or paclitaxel and rapamycin. The first additive is a surfactant. The second additive is a chemical compound having one or more hydroxyl, amino, carbonyl, carboxyl, acid, amide, or ester groups.

Abstract: A device and method for minimizing exposure of soft mucosa tissues to radiation, the device including a low-volume intracavity balloon catheter having multiple expansion portions, including an isometrically expanding portion and a substantially planar anterior portion.

Abstract: In at least one embodiment of the present invention a balloon catheter is provided. The balloon catheter comprises a shaft having a lumen formed therethrough. Connected to the shaft is an inflatable balloon. The inflatable balloon has a balloon wall defining a balloon interior surface and a balloon exterior surface that is opposite the interior surface. In fluid communication with the balloon wall is the lumen for inflating the balloon to define an inflated state and for collapsing the balloon to define a deflated state. The balloon wall is textured in the deflated state such that the balloon interior surface is spatially registered with the balloon exterior surface. The balloon in the inflated state is tensioned to have a surface roughness substantially less than a surface roughness of the balloon in the deflated state.

Abstract: Drainage systems for excess body fluids and associated methods are disclosed herein. A body fluid drainage system in accordance with an embodiment of the present technology, for example, can include a catheter that has an exterior surface, a proximal portion, and a distal portion opposite the proximal portion. The body fluid drainage system can further include a valve device, a pressure sensor, and a controller operatively coupled to the valve device and the pressure sensor. The valve device can include an actuator positioned over the exterior surface of the catheter. The actuator is movable between an open position that allows body fluid flow through the catheter, a closed position that at least substantially obstructs the body fluid flow through the catheter, and intermediate positions that partially obstruct the body fluid flow through the catheter. The controller can change the position of the actuator in response to a predetermined condition of the pressure sensor.

Abstract: Devices and methods can be used for the dilation of body conduits. For example, this document provides devices and methods for dilating a ureter using a dissolvable dilator element that is compatible with an ureteroscope system. Such a dissolvable dilator can be advanced into a patient's ureter via the urologic guidewire in front of the ureteroscope, giving immediate, one-step Cureteral access and offering less ureteral trauma at an economical price point.

Abstract: Provided is a novel delivery system for a percutaneous absorption drug preparation. The delivery system for a percutaneous absorption drug preparation is provided with: a solvent-impermeable first sheet; a solvent-impermeable second sheet that is bonded to the top surface of the first sheet and comprises a non-sealed area and a sealed area surrounding the non-sealed area, said non-sealed area and sealed area being formed between the first sheet and the second sheet, and a cutting part circularly extending along the outer peripheral edge of the non-sealed area; a percutaneous absorption drug preparation-holding member that is disposed between the first sheet and the second sheet in the non-sealed area and fixed to the second sheet inside the cutting part; and a pressure-sensitive adhesive third sheet that is removably bonded to the top surface of the second sheet.

Abstract: A method and a wash, clean and dry system are provided for washing, cleaning and drying a surface region of a human body. The system includes a toilet seat assembly with a bidet assembly having a spray canister device for spraying the surface region with a solution, such as a skin protecting barrier solution, a cleaning solution or a medicated solution. In one aspect, the spray canister device can be movably insert into and out of the toilet seat assembly and is easy to operate and use. In addition, the bidet assembly further includes a spray nozzle assembly and a drying nozzle assembly, which are adapted to wash, clean and dry the region of the human body in three dimensional moments. The removable spray canister device with the removable sleeved cover element is thus easy to carry and be re-filled with new solutions.

Abstract: An injection device for injecting a solid dose formulation into a human or animal body, the injection device comprising an actuator (10) having a cassette mounting portion (14); a cassette holder (20) having a cassette storage portion; and a cassette selectively movable between the cassette storage portion and the cassette mounting portion, wherein, the cassette (34) comprises a solid dose formulation and the actuator is receivable in the cassette holder to selectively move the cassette between the cassette storage portion and the cassette mounting portion.

Abstract: An apparatus includes cradle assemblies configured to respectively receive and support tattoo machines, in which the tattoo machines are configured to be electrically powered. A housing assembly is positioned relative to the cradle assemblies. The housing assembly is configured to selectively provide electrical power to the tattoo machines, in which the tattoo machines are to be respectively received and supported by the cradle assemblies. The housing assembly is configured to receive and support the cradle assemblies.

Abstract: An apparatus includes an introducer defining a lumen and a catheter movably disposed in the lumen. The introducer has a distal end portion configured to operably couple to an indwelling peripheral intravenous line at least partially disposed in a vein. The catheter is configured to be moved between a first position, in which the catheter is proximal to the peripheral intravenous line when the introducer is operably coupled thereto, and a second position, in which a distal surface of the catheter is distal to the introducer and disposed at a predetermined distance from a distal tip of the peripheral intravenous line. The predetermined distance defined between the distal surface of the catheter and the distal tip of the peripheral intravenous line is based at least in part on a venous anatomy associated with the vein.

Abstract: Drug delivery devices having integrated non-luer connectors are described. An exemplary drug delivery device includes a container with a non-luer connector that prevents connection of a standard female luer connector to the container. One or more embodiments pertain to a container with a non-luer connector that prevents the formation of a fluid-tight seal between a standard female luer connector and the container. A non-luer connector for attachment to a container having a non-luer element is also described.

Abstract: Disclosed is a dry electrode that electrically stimulates while contacting skin of a user, the dry electrode including a main body including a conductive body, and a nonconductive cover that surrounds the conductive body such that an area of the conductive body is exposed, and a patch detachably mounted on an area of the main body, in which the conductive body is exposed, one surface of the patch contacting the conductive body and an opposite surface of the patch contacting the skin of the user, the patch being configured to receive a current from the main body to electrically stimulate the skin of the user.

Abstract: A vestibular electrode is described that is for implantation into a vestibular semi-circular canal. An intra-labyrinthine electrode carrier with a C-shaped cross-section has an inner concave surface and an outer convex surface, and is configured to fit through an electrode opening in an outer surface of the bony labyrinth into the perilymph fluid without breaking the membranous labyrinth so as to fit the inner concave surface of the electrode carrier adjacent to the membranous labyrinth and the outer convex surface adjacent to the bony labyrinth. There are one or more electrode contacts on a surface of the electrode carrier that are configured for electrical interaction with adjacent neural tissue.

Abstract: An electrical stimulation lead includes a lead body; a terminal disposed along the proximal end portion of the lead body; a single electrode disposed at the distal end of the lead body; a conductor extending along the lead body and electrically coupling the terminal to the single electrode; and an adjustable sheath disposed over a portion of the lead body to cover a selected portion of the single electrode by displacing the sheath forwards or backwards relative to the single electrode to control a size of a portion of the electrode exposed for stimulation of tissue. Another electrical stimulation lead has a low-profile distal portion that has a smaller lateral width in at least one direction than a remainder of the lead body. Yet another arrangement includes a guidewire with a mapping electrode to map a region around a peripheral nerve prior to implantation of an electrical stimulation lead.

Abstract: In an interventional medical system, a delivery catheter for deploying a medical device of the system has a tethering assembly that includes a tether line, a grip member, and a release member, wherein the tether line extends through a longitudinal lumen of a base of the release member and is coupled to a base of the grip member, and the release member has legs extending though apertures formed through the base of the grip member. The device may be tethered to the catheter such that a proximal end of the device is held within a cavity defined by a plurality of elastic fingers of the grip member that extend distally from the base thereof; and the device may be deployed from the catheter by moving the legs of the release member within the grip member cavity to push the proximal end of the device out from the cavity.

Abstract: An orthosis having a first splint, which has a fastening device to fix the first splint to a first body part, an joint connected to a second splint, which in a donned/attached state of the orthosis bears on a second body part, and at least one electric stimulation device, which is adjustably fastened to the orthosis.

Abstract: This disclosure relates to using stereo-thermo-lesioning (STL) to create lesions at one or more locations in the patient's nervous system at the patient's bedside without general anesthesia. A method that uses STL to treat a patient's neurological condition includes: using a plurality of stereotactically-implanted thermo-coupled multi-contact electrodes to record conduction data within a predetermined theoretical zone of activity within the patient's neurological tissue; detecting abnormal neurological activity of a neurological condition within the conduction data and localize a portion of the predetermined theoretical zone of activity that is responsible for a primary organization of the abnormal neurological activity; creating a lesion at the portion of the predetermined theoretical zone of activity that is responsible for a primary organization of the abnormal neurological activity using at least one contact of the plurality of thermo-coupled multi-contact electrodes.

Abstract: Apparatus for providing transcutaneous electrical nerve stimulation (TENS) therapy to a user, the apparatus comprising: a housing; an application unit for providing mechanical coupling between the housing and the user's body; a stimulation unit for electrically stimulating at least one nerve of the user; a sensing unit for sensing the user's body movement and body orientation; and a reporting unit for providing the user with feedback based on the user's sensed body movement and body orientation.

Abstract: The present invention discloses neuro-stimulation systems and methods for affecting cardiovascular function, particularly for improving heart rate variability and treating arrhythmia.

Abstract: A system for controlling stimulation impulses, including at least one control unit and one item of clothing having a plurality of electrodes for electro-stimulation. The control unit is configured to carry out electro-stimulation with defined parameters at different electrodes and, during a training session, different parameters can be produced at different electrodes by said control unit.

Abstract: An implantable device, including an implantable module including a first functional component, the implantable module being configured to effectively differentiate between a plurality of different second modules respectively placeable into signal communication with the module. In an exemplary embodiment, the implantable module is configured to analyze respective signals from the plurality of different second modules and determine a respective functionality of the second modules based on the respective signals.

Abstract: Apparatus and methods for managing pain uses a single composite modulation/stimulation signal with variable characteristics to achieve the same results as separate varying electromagnetic signals. The composite signal is utilized for modulating the expression of genes involved in diverse pathways including inflammatory/immune system mediators, ion channels and neurotransmitters, in both the Spinal Cord (SC) and Dorsal Root Ganglion (DRG) where such expression modulation is caused by spinal cord stimulation or peripheral nerve stimulation using the disclosed apparatus and techniques.

Abstract: Systems and methods are disclosed for selectively reinforcing or weakening memory associations. At least one current generator provides an electrical current including a plurality of oscillating pulses with at least one predetermined frequency. A user interface includes at least one output device for delivering a sensory stimulus to a user and at least one user input device for registering a response to the stimulus. At least one processor determines from the response, based on at least one predetermined standard, whether an underlying memory association is desired or undesired and respectively sets the at least one predetermined frequency to be a beta or theta frequency. Consequently, the electrical current is generated and administered, via at least one electrode pair, thereby stimulating at least one specific portion of the user's brain so as to reinforce or weaken the underlying memory association.

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: An example of a system may include an electrode arrangement, a neural modulation generator configured to use electrodes in the electrode arrangement to generate a modulation field, a communication module configured to receive commands, a memory configured to store modulation field parameter data, and a controller configured to control the neural modulation generator to generate the modulation field. The controller may be configured to implement a trolling routine to troll the modulation field through neural tissue positions, and implement a marking routine multiple times as the modulation field is trolled through the neural tissue positions to identify when the modulation field provides patient-perceived modulation.

Abstract: Apparatus includes an implant and an introducer. The implant includes an injectable housing, an electrode disposed on an outer surface of the housing, and circuitry. The circuitry is configured to alternate between a first mode in which the circuitry drives the electrode to apply a first electrical current having a frequency of 1-100 Hz, and a second mode in which the implant applies a second electrical current having a frequency of 1-10 kHz. The introducer includes a tube that defines a lumen and is percutaneously-advanceable into tissue of the subject, the lumen being dimensioned to at least temporarily house the implant. The introducer is configured to deploy the implant from a distal end of the lumen by moving the implant and the distal end of the lumen relative to each other. Other embodiments are also described.

Abstract: Systems and methods are provided for delivering vagus nerve stimulation and carotid baroreceptor stimulation to patients for treating chronic heart failure and hypertension. The vagus nerve stimulation and carotid baroreceptor stimulation therapies may be provided using a single implantable pulse generator, which can coordinate delivery of the therapies.

Abstract: Presented herein are magnet arrangements for use with encapsulated implantable components. An implantable component comprises an implant body and a plurality of wire loops forming an internal coil that are encapsulated in a biocompatible overmolding. The implantable component also comprises a bone fixture positioned proximate to the plurality of wire loops and an implantable magnet attached to the bone fixture.

Abstract: An implantable medical device configured to be compatible with the environment inside an Mill machine. The implantable medical device includes a housing constructed of an electrically conductive material and pulse generation circuitry within the housing for generating electrical voltage pulses. The implantable medical device further includes a first conductor that is configured to transmit the electrical voltage pulses from the pulse generation circuitry to a patient's cardiac tissue and a second conductor that is configured to provide an electrically conductive path from the patient's cardiac tissue back to the pulse generation circuitry. The implantable medical device further includes a selectively interruptible electrically conductive path connecting the pulse generation circuitry with the housing.

Abstract: A connector assembly includes a connector housing having longitudinal axis and a port for receiving a proximal end of a lead having terminals electrically insulated from one another. A lumen extends along the longitudinal axis. Contacts are disposed in the housing and electrically insulated from one another. The contacts couple to the terminals when the proximal end is received within the lumen. The contact includes a contact ring and ball-spring assemblies distributed around the contact ring. Each ball-spring assembly includes a housing coupled to the contract ring, a biasing member disposed within the ball-spring housing, and a conductive ball disposed at least partially within the ball-spring housing. The ball-spring housing defines an opening that is smaller than a diameter of the ball and the biasing member urges the ball towards the opening so that a portion of the ball extends out of the opening in the ball-spring housing.

Abstract: An electromedical implant, having a housing with three housing segments A, B and C. Segment A is joined to segment B, and segment B is joined to segment C, so that segment B is disposed between segments A and C. Segment A and segment C are at least partially made of electrically conducting material. Furthermore, an electronics module is disposed within housing segment A and has an electric circuit arrangement for picking up and further processing electrical signals, and at least one first and one second electrical conductor for measuring electrical potentials and/or for delivering electric pulses. Each conductor has a conductor start and a conductor end, and each conductor start is connected to the electric circuit arrangement. An electrical feedthrough is at least partially made of electrically insulating material, and segment B is formed by portions of the feedthrough.