Abstract: The invention is a frameless, disposable cloth body for use with a respiratory mask, such as for continuous positive airway pressure therapy for those having sleep apnea. The cloth body is inflatable and moisture-vapor breathable and has an inner side having a nasal interface portion disposed on it and an outer side, and also has a circular aperture formed in a central location on the body, sized to sealingly receive an air delivery arrangement. The cloth body also has a pair of wings on opposite sides with slits arranged at optimal angles for receiving headgear straps.

Abstract: The invention relates to a pressure responsive respiratory valve apparatus for enabling positive pressure from a source of pressure to be applied to a user's airway, and allowing ingress of a breathable gas from an inlet port into a user's airway during inhalation and egress of expired tidal volume of air from the user's respiratory system to an exhalation port during exhalation. The invention minimises rebreathing of expired gas and optimizes delivery of pressurised breathable gas by venting gas only during exhalation, as well as addressing important user considerations including minimizing noise, pressure swing, and size.

Abstract: The invention relates to a breathing assistance device for a patient, the device including: a source of respiratory pressurised gas; a gas transmission duct comprising a distal end coupled to said source and a proximal end coupled to the patient; a gas regulating valve interposed in the gas transmission duct at a proximal location, comprising a leakage orifice and an obstruction means capable of varying the opening of the leakage orifice upon signal of controlling means and allowing a bidirectional gas flow through the leakage orifice in both expiration and inspiration phases.

Abstract: A device for crimping an collapsible device and loading the collapsible device into a delivery system, includes a crimping tool configured to radially crimp at least a portion of the collapsible device, a loading tool configured to load at least a portion of the collapsible device into a delivery system, and a housing that houses at least one of the crimping tool and loading tool, wherein the device is configured to crimp and load the collapsible device without requiring manual repositioning of the collapsible device. Methods of crimping an collapsible device and loading the collapsible device into a delivery system are also disclosed.

Abstract: A turbulator for promoting mixing of fluids passing through a body lumen includes an elongate flow perturbing component and an elongate shape controlling component freely slidable within the flow perturbing component. The turbulator is adjustable from a low profile, lumen access configuration to a deployed configuration via sliding the shape controlling component within the flow perturbing component. Adjusting the turbulator within a body lumen of a patient induces turbulence within a flow of fluid passing through the body lumen to increase mixing of a treatment fluid with the body fluid by way of the induced turbulence.

Abstract: Devices and methods for the effective clearing of artificial tubes, for example, in-situ clearing of artificial tubes in a living being are covered in this disclosure. The devices and methods provide a controller comprising at least one actuator for generating repetitive motion, and a stem coupled to the at least one actuator. The stem includes at least one fluid source, a conduit member in fluidic communication with the fluid source, and a reciprocating member at least partially disposed within the conduit member and configured to accept the repetitive motion. The fluid source includes a deformable reservoir and/or a port.

Abstract: A catheter actuation handle apparatus is disclosed that is designed and configured for manipulating one or more distally-extending members to achieve translation, articulation and/or rotation of these members using the actuation handle.

Abstract: An active catheter device is provided. At least one elongate catheter segment includes an elongate flexible tube member defining an axis, and a pair of ferrule members operably engaged with and spaced apart along the tube member. The ferrule members are not rotatable about the axis relative to each other. At least one articulation member is operably engaged with and extends at least between the ferrule members along the tube member. Each articulation member is configured to be actuatable to cause a change in a distance between the ferrule members so as to articulate the tube member. Associated systems and methods are also provided.

Abstract: A hemostasis component for an invasive medical device has an inflatable cylinder affixed to the medical device at a location aligned with an ingress point of a patient. An inflation source is in fluid communication with the inflatable cylinder and a flow control valve that is effective to regulate the flow of fluid from the inflation source to the inflatable cylinder is provided. The flexible cylinder is located on the proximal end of a tunneling catheter, where it exits the skin. A thin tube is provided to inflate the flexible cylinder. In the event of bleeding, the flexible cylinder is inflated for as long as is needed to achieve hemostasis, without having to place sutures. Inflation is a simple procedure that can be done by the patient, as opposed to having to place a suture, which must be performed by a physician or a physician's delegate, under sterile conditions.

Abstract: An IV catheter introducer assembly including a catheter hub defining a chamber; a tubular member extending distally from the catheter hub having a length and defining a lumen, the lumen being in fluid communication with the chamber and configured to removably receive an introducer needle. The device also including a retention member disposed within the chamber having a body having a central lumen having a longitudinal length extending along a lengthwise direction to the length of the tubular member and sized to seal against an introducer needle. The retention member including a venting channel having at least a portion formed as a conic helix traversing a surface of the retention member along a radial path to the lengthwise direction.

Abstract: A needle retraction apparatus comprising a body having a forwardly projecting needle, a needle retraction mechanism seated inside the body and biasing the needle rearwardly relative to the body, a slide member attachable to the body and having an opening communicating with a needle retraction cavity projecting away from the body, and an actuator rotatable relative to the slide member to reposition the slide member from a first position preventing needle retraction to a second position permitting needle retraction. An IV catheter introducer comprising the subject needle retraction apparatus is also disclosed.

Abstract: A safety needle system operable with a medical device includes: a housing with a needle mount having a needle; and a sheath telescopically engaged with the housing and surrounding the needle such that the sheath operates in a retracted position, in which the sheath exposes the needle, and an extended position, in which the sheath surrounds the needle. The sheath is coupleable to the medical device such that removal of the needle from the medical device draws the sheath over the needle, transitioning the sheath from the retracted position to the extended position. In one embodiment, the system includes a slider engaged with the sheath and/or housing and including a restraint that engages and disengages the sheath to respectively reinforce and weaken the coupling of the sheath and medical device. In another embodiment, the sheath includes a longitudinal track that slidingly engages a setting of the housing between sheath positions.

Abstract: Embodiments of the invention include apparatus and methods for coating drug eluting medical devices. In an embodiment, the invention includes a coating apparatus including a coating application unit comprising a movement restriction structure; a fluid applicator; and an air nozzle. The apparatus can further include a rotation mechanism and an axial motion mechanism, the axial motion mechanism configured to cause movement of at least one of the coating application unit and the rotation mechanism with respect to one another. Other embodiments are also included herein.

Abstract: Occlusion bypassing apparatuses are disclosed for re-entering the true lumen of a vessel after subintimally bypassing an occlusion in a vessel. The occlusion bypassing apparatuses include a shaft component and a needle component slidably disposed within the shaft component and having an angled configuration when deployed. In embodiments hereof, the needle component has an angled distal tip segment that may be utilized to selectively bend a flexible distal portion of the shaft component in order to extend the flexible distal portion towards the true lumen of the vessel. The needle component is distally advanced relative to the shaft component to pierce through the intima of the vessel and thereafter enter the true lumen.

Abstract: A cyst extractor allows a medical practitioner to retract, aspirate, ligate and amputate a cyst or cystic mass within a patient under regional anaesthesia and minimally invasive incision. A cyst extractor may include a transparent tubular member with a cap coupled to one end. The cap may have at least one view port that has a magnifying lens. The cap may also have a needle port through which a needle is inserted to puncture the cyst. A trap may be in fluid communication with the transparent tubular member. A suction post is in communication with the trap in order to pull the contents of an aspirated cyst into the trap. A light post containing a light source may be connected to the transparent tubular member in order to illuminate the interior of the extractor. A ligature deployer and a cutting wire may also be coupled to the tubular member.

Abstract: An implant device is configured to be implanted in a fistula to fluidly connect the lacrimal apparatus and a paranasal sinus. A surgical tool has an implant the implant device mounted on a carrier. Various methods involve a fistula between the lacrimal apparatus and a paranasal sinus. A kit includes an entry device for use to form a fistula and an implant tool for use to implant an implant device following formation of a fistula.

Abstract: A ureteral stent assembly includes a ureteral stent having a distal end portion, a proximal end portion, and a medial end portion. The ureteral stent assembly also includes an elongate positioner for positioning the ureteral stent within the body of the patient. The positioner includes a distal end portion, a proximal end portion, and a medial end portion. A coupling mechanism configured to removably or releasably couple the ureteral stent to the elongate positioner is located on at least one of the distal end portion of the ureteral stent, the medial portion of the ureteral stent, the distal end portion of the positioner, and the medial portion of the positioner. In one embodiment, the ureteral stent includes a lumen that is configured to receive the positioner, and the positioner includes a lumen that is configured to receive a guidewire.

Abstract: A cardiovascular prosthetic valve, the valve comprising an inflatable cuff comprising at least one inflatable channel that forms, at least in part, an inflatable structure, and a valve coupled to the inflatable cuff, the valve configured to permit flow in a first axial direction and to inhibit flow in a second axial direction opposite to the first axial direction, the valve comprising a plurality of tissue supports that extend generally in the axial direction and that are flexible and/or movable throughout a range in a radial direction.

Abstract: A method for treating ethmoid disease in human or non-human animal subjects includes inserting a sheath containing an implantable device having an expandable member. The sheath is removed from the implantable device causing the expandable member to expand, allowing for stability of the implantable device in the subject. Stenting, spacing, draining, ventilating and/or delivering drugs and other therapeutic or diagnostic substances to desired locations within the bodies of human or non-human animal subjects may also be involved.

Abstract: A male needleless connector includes a body having a male fitting with a distal port, a valve disposed within the body and having a first position wherein the valve seals the port and a second position wherein the valve does not seal the port, and a sliding seal disposed over a portion of the male fitting and having a first configuration wherein a first portion of the sliding seal is in sealing contact with the male fitting and a second configuration wherein the first portion is not in sealing contact with the male fitting. Moving the sliding seal to the second configuration opens the seal between the sliding seal and the male fitting and displaces the valve to the second position, thereby opening the seal between the valve and the port.

Abstract: Various aspects of this disclosure relate to a patch for treating a patient for chronic pain and for cosmetic treatment. As consistent with one or more embodiments, neurostimulation is carried out via stimulating electrodes and one or more reference electrodes applied externally to a region of pain (e.g., by applying current between 0.2 and 60 mA to skin). The area to be treated is located either by a stimulating device, or by using at least one of the stimulating electrodes on the device itself to locate the pain prior to treatment. The electrodes are applied to the patient's skin as located using firm pressure while a stimulating pulse is applied as treatment. This action produces a remarkable and unexpected level of pain relief over a wide area. Aspects of the disclosure extend to a method for the treatment of chronic pain using the above-mentioned parameters and procedures.

Abstract: A lead assembly includes an implantable lead. Electrodes are disposed along a distal end of the lead in an electrode array. Terminals are disposed along a proximal end of the lead in a proximal-most terminal array and a medial terminal array. A terminal extension electrically couples to the medial terminal array. A port is defined in a connector at a first end of the terminal extension. The port has a first end and an opposing second end and forms a continuous passageway therebetween. The port receives the medial terminal array. A contact array includes connector contacts that are disposed within the port and that couple electrically with a terminal array disposed along a second end of the terminal extension. The contact array couples electrically with terminals of the medial terminal array of the lead when the medial terminal array is received by the port.

Abstract: A detachable electrode and anchor utilized with electrode leads and leadless medical implants that enable explantation of the electrode while leaving the anchor in place. The detachable electrode and anchor utilizes a detachable mechanism that detachably couples the electrode to the anchor. Embodiments do not require removal of existing scar tissue before explantation, which minimize chances of internal bleeding at the extraction site. Embodiments also minimize impact on the vein in which the electrode lead travels by eliminating use of a necessarily larger diameter sheath that is utilized around the electrode lead to remove the electrode lead and attached anchor.

Abstract: Disclosed is apparatus 100 for the reduction or removal of smoke particles suspended in a local atmosphere A and resulting from a surgical procedure, the apparatus including or comprising two electrodes 140 and 150 each in electrical communication with or being electrically connectable to opposite poles of a source of high voltage dc electricity. A first of the electrodes 140 may be electrically connectable to a patient P. and a second 150 may be positionable within or adjacent a patient such that the two electrodes, when in communication with opposite poles of said high voltage, ionize said particles in use, for attracting said particles toward the patient or toward the second of the electrodes.

Abstract: Aspects of the present invention are generally directed to taking measurements in a hearing prosthesis. In an embodiment, a power circuit, which may be a switched mode power circuit, is shut down during performance of the measurements to reduce interference. Then, power capacitively stored by the power circuit is used to power the hearing prosthesis during performance of the measurements. In an embodiment, the power circuit increases its voltage just prior to performance of the measurements. This serves to increase the amount of energy capacitively stored by the power circuit and thus extends the period of time during which the measurements may be taken while the power circuit is shut off.

Abstract: A visual prosthesis must convey luminance information across a range of brightness levels to accurately represent a visual scene. Thus, the brightness of phosphenes produced by individual electrodes should scale appropriately with luminance, and the same luminance should produce equivalently bright phosphenes across the entire electrode array. Given that the function relating current to brightness varies across electrodes, it is necessary to develop a fitting procedure that will permit brightness to be equated across an entire array. A visual prosthesis that generates stimuli by performing a brightness fitting that normalizes brightness across electrodes is described.

Abstract: Spinal cord stimulation (SCS) system having a recharging system with self-alignment, a system for mapping current fields using a completely wireless system, multiple independent electrode stimulation outsource, and IPG control through software on Smartphone/mobile device and tablet hardware during trial and permanent implants. SCS system can include multiple electrodes, multiple, independently programmable, stimulation channels within an implantable pulse generator (IPG) providing concurrent, but unique stimulation fields. SCS system can include a replenishable power source, rechargeable using transcutaneous power transmissions between antenna coil pairs. An external charger unit, having its own rechargeable battery, can charge the IPG replenishable power source. A real-time clock can provide an auto-run schedule for daily stimulation. A bi-directional telemetry link informs the patient or clinician the status of the system, including the state of charge of the IPG battery.

Abstract: A method for controlling a position of a patient's tongue includes attaching at least one electrode to the patient's hypoglossal nerve, applying an electric signal through the electrode to the hypoglossal nerve to stimulate at least one muscle of the tongue at least until the number of obstructive sleep apnea occurrences are reduced from an initial level to a treatment level, and reducing the application of the electric signal while the number of obstructive sleep apnea occurrences remain generally at or below the treatment level.

Abstract: A current generation architecture for an implantable stimulator device such as an Implantable Pulse Generator (IPG) is disclosed. Current source and sink circuitry are both divided into coarse and fine portions, which respectively can provide coarse and fine current resolutions to a specified electrode on the IPG. The coarse portion is distributed across all of the electrodes and so can source or sink current to any of the electrodes. The coarse portion is divided into a plurality of stages, each of which is capable via an associated switch bank of sourcing or sinking a coarse amount of current to or from any one of the electrodes on the device. The fine portion of the current generation circuit preferably includes source and sink circuitry dedicated to each of the electrode on the device, which can comprise digital-to-analog current converters (DACs).

Abstract: A system and method for displaying a volume of activation (VOA) may include a processor that displays via a display device a model of a portion of a patient anatomy that includes anatomical structures, displays via the display device and overlying the display of the model a VOA associated by the processor with a set of anatomical stimulation parameter settings, the display of the VOA, and graphically identifies interactions between the displayed VOA and a first subset of the anatomical structures associated with one or more stimulation benefits and a second subset of the anatomical structures associated with one or more stimulation side effects, where the graphical identifications differ depending on whether the interaction is with the first subset or the second subset.

Abstract: A group select matrix is added to an implantable stimulator device to allow current sources to be dedicated to particular groups of electrodes at a given time. The group select matrix can time multiplex the current sources to the different groups of electrodes to allow therapy pulses to be delivered at the various groups of electrodes in an interleaved fashion. Each of the groups of electrodes may be confined to a particular electrode array implantable at a particular non-overlapping location in a patient's body. A switch matrix can be used in conjunction with the group select matrix to provide further flexibility to couple the current sources to any of the electrodes.

Abstract: Some embodiments of an electrical stimulation system employ wireless electrode assemblies to provide pacing therapy, defibrillation therapy, or other stimulation therapy. In certain embodiments, the wireless electrode assemblies may include a guide wire channel so that each electrode assembly can be advanced over a guide wire instrument through the endocardium. For example, a distal tip portion of a guide wire instrument can penetrate through the endocardium and into the myocardial wall of a heart chamber, and the electrode assembly may then be advanced over the guide wire and into the heart chamber wall. In such circumstances, the guide wire instrument (and other portions of the delivery system) can be retracted from the heart chamber wall, thereby leaving the electrode assembly embedded in the heart tissue.

Abstract: Methods and devices for classifying a cardiac pacing response involve using a first electrode combination for pacing and a second electrode combination for sensing a cardiac signal following pacing. The cardiac response to pacing may be classified using the sensed cardiac signal. One process involves using the sensed cardiac signal to detect the cardiac response as a fusion/pseudofusion beat. Another process involves using the sensed cardiac signal to classify the cardiac response to pacing as one of at least three cardiac response types.

Abstract: A method and apparatus for identifying loss of capture in a pacing device. While pacing pulses are being delivered, the device checks for emergence of a stable asynchronous underlying intrinsic rhythm in the presence of the delivered pacing pulses. The device determines that loss of capture has occurred responsive to emergence of the underlying rhythm. In response to determining that loss of capture has occurred, pacing provided by device is modified, for example by performing a threshold test and adjusting the energy levels of delivered pacing pulses in response thereto.

Abstract: A system for transmitting a signal through an imperfectly-conducting medium includes a transmitter station and a receiver station. The transmitter station has a transmitter and at least one conductor (electrode). The receiving station has at least one conductor (electrode) and a receiver. The transmitter causes a current to flow from the transmitter conductor to the receiver conductor through the imperfectly-conducting medium. Associated with the current flow is an electric field. Because the current flow varies with the signal, the electric field varies with the signal. The receiving conductor senses the electric field and provides a signal to the receiver which detects the signal to be transmitted. The receiving station then passes the signal to an output device to be output.

Abstract: Systems, methods, and devices for wireless recharging of an implanted device. In response to receiving identification information from an implanted device, a charger can set an electrical field to a first field strength and receive first field strength information from the implanted device. The charger can then set the electrical field to a second field strength and receive second field strength information from the implanted device. This information relating to the first and second field strengths can be used to determine whether to recharge the implanted device.

Abstract: A out-of-hospital cardiac treatment apparatus, comprising: a cardiac waveform monitor capable of sensing a physiological signal from a heart of a patient and wirelessly transmitting the sensed physiological signal to a remote medical provider, an electrical stimulator adapted to deliver a therapeutic dose of electrical energy to the heart of the patient, a medical provider transceiver adapted to receive the sensed physiological signal from the cardiac waveform monitor and also wirelessly transmit a command signal to control the electrical stimulator.

Abstract: An example includes an apparatus for use within a header of an implantable medical device, the apparatus including a substantially annular spring, sized and shaped to be disposed in the header, the spring defining a loop extending about a central axis, the spring including a plurality of elastically deformable switchback portions that both zigzag and curve transversely about the loop to define a surface that at least partially encompasses the loop.

Abstract: An implantable device is provided. The implantable device may include a flexible carrier configured for implantation in a subject, at least one pair of modulation electrodes associated with the carrier, an antenna configured to receive an electrical signal disposed on the flexible carrier, a circuit electrically coupling the antenna to the at least one pair of modulation electrodes; and a ceramic housing. At least one of the antenna and the circuit may be located within the ceramic housing.

Abstract: Improved assemblies, systems, and methods provide a stimulation system for prosthetic or therapeutic stimulation of muscles, nerves, or central nervous system tissue, or any combination. The stimulation system includes an implantable pulse generator and a lead sized and configured to be implanted subcutaneously in a tissue region. An external controller includes circuitry adapted for wireless telemetry and a charging coil for generating the radio frequency magnetic field to transcutaneously recharge a rechargeable battery in the pulse generator. Using wireless telemetry, the pulse generator is adapted to transmit status information back to the external controller to allow the external controller to automatically adjust up or down the magnitude of the radio frequency magnetic field and/or to instruct a user to reposition the charging coil, the status information adapted to allow optimal recharging of the pulse generator rechargeable battery.

Abstract: A method, apparatus and computer program for defibrillation delivery decision comprising the steps of: a) Determining a shockable rhythm with a first algorithm, whereby said first algorithm is adapted to analyze an ECG signal in the presence of chest compression; b) Determining a shockable rhythm with a second algorithm, whereby said second algorithm is adapted to analyze an ECG in the absence of chest compression; c) Determining with a third algorithm if the patient is undergoing chest compression.

Abstract: A medical device includes a display area that has a thin panel having a substantially flat front surface portion, a translucent layer on a back surface of the thin panel, a layer of text or graphics on a back surface of the translucent layer, and arranged so that the text or graphics is not visible to a user on the front side when light is not provided from inside the device housing. Also included is a switch to allow a user to select a first mode or a second mode for the device, and circuitry arranged to energize one or more light sources to provide light from behind the thin panel when the device is in the first mode, thereby making visible the text or graphics when the device is in the first mode.

Abstract: Repetitive Transcranial Magnetic Stimulation (rTMS) is administered at a pulse rate that is equal to or a harmonic of a biological metric of a patient. The purpose is to provide frequency coupling among different organs (e.g., heart, brain, breathing, and gastrointestinal movement) through rhythmic entrainment. The specific harmonic chosen is the one closest to a desired EEG frequency. The desired EEG frequency is chosen based on the cognitive element or symptom that is targeted.

Abstract: The inventive technique includes a system, method and device for treating a patient. The device includes a magnetic device having a core created by a binder process having a relatively low temperature. The device further includes a conductor in electrical communication with the core.

Abstract: Described are methods, devices, and systems for a novel, inexpensive, easy to use therapy for a number of disorders. Described are methods and devices to treat disorders that involves no medication. Methods and devices described herein use alternating magnetic fields to gently “tune” the brain and affect mood, focus, and cognition of subjects.

Abstract: Ceramic footbath boots, ceramic materials for manufacturing the ceramic footbath boots and application of the ceramic materials to the manufacture of the ceramic footbath boots are disclosed herein. The ceramic footbath boots include a pair of boot-like footbath containers (1). The footbath containers (1) are made of the ceramic materials, and the internal walls of the footbath containers are provided with net-like lines and papillary groups (2) corresponding to the reflex point zone of feet. The ceramic materials can: emit far infrared rays with wave length of 4-14 microns and the emitting rate of more than 0.92 at normal temperature; release negative ions automatically and permanently; continuously produce weak static current matching the bioelectric current of human bodies; and release mineral matters and trace elements needed by human bodies into water. The ceramic materials are preferably tourmaline-containing silicates.

Abstract: An extra-oral light therapy device comprises a support that registers against features of a patient's head. A light source is mounted to the support. The light source may comprise an array of light emitting diodes (“LEDs”). A controller controls the extra-oral light therapy device. The support may comprise a tray fitted to the patient's teeth or a head-set fitted to the patient's ears and the bridge of the patient's nose. An external light therapy device has a thin, molded substrate, at least one array of light emitters mounted onto the thin, molded substrate, an attaching means for removably attaching the device to an area of treatment, and a controller for controlling the external light therapy device. Methods for supporting light sources adjacent desired treatment locations and for treating jaw bone disorders and jaw osteonecrosis and biostimulating bone and soft tissue are also disclosed.

Abstract: A device for treating an area of skin by scanning radiation to form a pattern of treatment spots on the skin may include a radiation source that generates an input beam, and a scanning system that scans the input beam to provide a sequential series of reflected output beams that form a pattern of treatment spots on the skin. The scanning system may include a rotating scanning element including a plurality of reflection surfaces, each configured to reflect the input beam in an angular direction to provide one of the reflected output beams, such that as the rotating scanning element rotates about an axis, the input beam is sequentially reflected by different reflection surfaces to provide the sequential series of reflected output beams, wherein a first reflection surface is offset from a second reflection surface in a direction generally along the axis of rotation of the rotating scanning element.

Abstract: A self-contained, hand-held device for providing a dermatological treatment may include a device body configured to be handheld by a user, a radiation source including a beam source configured to generate an energy beam, an application end configured to be manually moved across the surface of the skin, a sensor configured to generate signals based on an interaction with the skin, and electronics configured to automatically identify a series of intrinsic skin features based on the sensor signals, and control at least one operational parameter of the radiation source based at least on the identification of such skin features.

Abstract: A variety of methods, devices, systems and arrangements are implemented for stimulation of the peripheral nervous system. Consistent with one embodiment of the present invention, method is implemented in which light-responsive channels or pumps are engineered in a set of motor units that includes motor units of differing physical volumes. Optical stimuli are also provided to the light-responsive channels or pumps at an optical intensity that is a function of the size of motor units to be recruited. In certain implementations, the intensity of the optical stimuli is increased so as to recruit increasingly larger motor units.