Abstract: A valve for an aerosol canister for containing medicaments is disclosed. The valve comprises a valve assembly, a ferrule for holding the valve assembly and a gasket for insertion into the ferrule. The ferrule has at least one ferrule interference surface and the gasket has at least one gasket interference surface, and the contact zone between the ferrule interference surface and the gasket interference surface comprises a plurality of relief portions. Preferably, the ferrule interference surface comprises a plurality of ferrule relief pockets and the gasket interference surface comprises a plurality of gasket relief pockets. Also disclosed is a method of manufacturing a valve for an aerosol canister.

Abstract: An inhalation training device and inhalation training system for practicing of an inhalation process of a patient. The inhalation training device has a that is housing attachable to and detachable from a mouthpiece of an inhaler designed to provide a drug to the patient and a microphone adapted to measure the airflow occurring in the mouthpiece of the inhaler during an inhalation process of the patient. The inhalation training system includes the inhalation training device, an inhaler and an electronic device configured for evaluation of a signal received from the inhalation training device and for visual and/or audio feedback to the patient.

Abstract: It is a support mask with a mounting strip to the head of the user. Inside the mask, the actuating mask is fixed with its vapor inlet tube connected, removable, with the injector tube of an external receptacle where a micro compact removable nebulizer is set up. The micro nebulizer has a micro ultrasonic cavitation microsystem capable of generating the vibrations necessary to vaporize the medicated liquid contained in a built-up tank. That ultrasonic mechanism is activated by a small electronic device with an activation button that is housed in a side enclosed area and is powered by batteries inside a similar battery enclosed area on the opposite side. The external surface of said support mask, presents, in strategic places, fixation means to enable an external party face mask of a laminar material molded similar to those characters admired by children.

Abstract: An apparatus for endotracheal intubation. The apparatus allows medical personnel to grip and stabilize a bougie inside the apparatus and maintain a curve position during intubation processes. The apparatus can be used for a solid bougie and/or a hollow bougie. The apparatus may further have a connector for connecting the apparatus to an external suction device or oxygen delivery device.

Abstract: A mask assembly for use as part of an apparatus for supplying a flow of respiratory gases to a user is disclosed. The mask assembly includes a mask body having an inlet through which said flow of respiratory gases are provided to the interior of said mask body. A mask seal assembly comprising a seal of flexible material and a clip of rigid material is attached to the body. The seal has a first side and a second side. The first side of the seal is shaped to approximately match the contours of a user's face and in use substantially seal against a user's face. The second side is attached to the clip. The clip provides an interface extending substantially the full perimeter or periphery of the mask seal assembly for releasably attaching the mask seal assembly to the mask body. The clip comprises a bridging portion spanning outwards from the perimeter or periphery of the mask body to space at least a portion of the second side of the seal outwards from the perimeter or periphery of the mask body.

Abstract: A system and method to control oxygen supply uses determinations whether physiological sensors and/or a subject interface appliance have been displaced in relation to a subject and/or there has been movement of the subject itself. Artifacts that may reduce the accuracy of measurements of physiological parameters, in particular related to a level of arterial oxygen saturation, may be detected through determinations pertaining to sensor displacement, displacement of the subject interface appliance and/or movement of the subject.

Abstract: An breathing or anesthesia apparatus and a process for operating a breathing or anesthesia apparatus are provided in which only a very low energy consumption occurs outside of the operating times. The breathing or anesthesia apparatus (1) is put into an energy-saving mode and a function pretest is performed before putting the apparatus into the energy-saving mode. A function self-test is carried out when the breathing or anesthesia apparatus is put into a standby mode.

Abstract: A low cost medical humidifier for adding moisture to a patient air flow is disclosed. The humidifier comprises a water reservoir, a disposable evaporative wick containing a heater, a lid containing electrical contacts to engage the heater in the wick and airway connections. The wick heater comprises a PET film with aluminum tracks and a cover layer of PTC resistive ink. The heater is covered with paper to provide a water pathway via capillary flow. There is a capillary path from the water reservoir to the wick. The wick and heater are manufactured with printing and calendaring processes in reel to reel processes.

Abstract: This invention relates to a treatment device (10) and method of use, and in particular to a treatment device adapted to assist the clearance of bronchial secretions in persons whose cough function is impaired. The invention provides a treatment device having a pump (12) with a negative pressure inlet side (22) and a positive pressure outlet side (24). The device has a breathing tube (14) for connection to a patient, and a pressure sensor (18) adapted to determine the pressure within the breathing tube. A valve (16) selectively connects the breathing tube to the inlet side or the outlet side of the pump whereby to provide cycles of positive and negative pressure within the breathing tube. A controller (26) is provided to control the valve. An indicator (20) alerts the patient to an operational status of the device so that the patient can breathe in time with the device and in particular can seek to cough at the same time as the pressure within the breathing tube is rapidly reduced.

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 minimizes rebreathing of expired gas and optimizes delivery of pressurized breathable gas by venting gas only during exhalation, as well as addressing important user considerations including minimizing noise, pressure swing, and size.

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: A gas delivery system including a gas delivery device, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gas are also described.

Abstract: A device for treating a patient suffering from obstructive sleep apnea or snoring can include an expiratory valve connected to a manifold. The expiratory valve can include a body portion including a feedback port configured to be connected to an air flow generator. The expiratory valve can include a plunger at least partially disposed in the body portion. The expiratory valve can include a pressurizing chamber positioned between an end of the plunger and an end of the expiratory valve. The pressurizing chamber can be configured to receive air from the air flow generator through the feedback port.

Abstract: A catheter assembly is disclosed, comprising a proximal catheter assembly portion and a distal catheter assembly portion. The proximal catheter assembly portion includes a bifurcating hub that defines at least one fluid passageway. The distal catheter assembly portion includes a catheter tube that defines at least one lumen and includes a polymeric material. A cannula assembly is also disclosed and includes at least one cannula that is operably connected with the fluid passageway of the birfurcating hub. The cannula is further configured to operably connect with the lumen of the catheter tube so as to provide fluid communication between the proximal and distal catheter assembly portions when the two portions are connected. A polymeric coating is included with the cannula and the catheter tube, and is configured to provide a seal between the cannula and the catheter tube when the proximal and distal catheter assembly portions are connected together.

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

Abstract: Embodiments of the present invention are directed to a rigid connector which joins an inflation lumen to an inflatable element in a medical device. The connector comprises a shaft fluidly connected to a crossbar. Preferably one embodiment provides a stable junction through which an inflation fluid may pass and inflate an inflatable element which is not co-linear with the axis of inflation. The junction maintains a generally rigid, fixed angle in relation to the axis of the inflation lumen, which in many embodiments is perpendicular to said axis. This fixed orientation creates a robust structure which is resistant to deflection when forces are encountered during its use within tubular and non-tubular structures within the human body. Such a structure maintains a rigid orientation between the inflatable element and the catheter body.

Abstract: Systems and methods for implanting an endovascular shunt in a patient is disclosed. The system having an expandable anchor configured for being deployed in a dural venous sinus of a patient at a location distal to a curved portion of a wall of an inferior petrosal sinus (IPS) of the patient; an elongate guide member coupled to, and extending proximally from, the anchor; a shunt delivery catheter having a first lumen configured to receive the guide member, and a second lumen extending between respective proximal and distal openings in the shunt delivery catheter, the shunt delivery catheter further having a penetrating element coupled to a distal end of the catheter; and the system further having a guard at least partially disposed over, and movable relative to, the penetrating element.

Abstract: Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The sheath is configured for use in the vascular system. The access route is through the inferior vena cava to the right atrium, where a trans-septal puncture, followed by advancement of the catheter is completed. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement through the atrial septum into the left atrium. The distal end of the sheath is expanded using a radial dilator. In one application, the sheath is utilized to provide access for a diagnostic or therapeutic procedure such as electrophysiological mapping of the heart, radio-frequency ablation of left atrial tissue, placement of atrial implants, valve repair, or the like.

Abstract: A fluid delivery system for delivering fluid to an inner ear of a subject includes a septum configured to be embedded in the inner ear or on a promontory bone of the subject, a spear connector having a needle for insertion into the septum, a catheter in fluid communication with the spear connector, a fixation device configured to secure the septum to the inner ear or the promontory bone.

Abstract: The present disclosure relates generally to microneedle devices and methods for fabricating microneedles from a biocompatible polymer using photolithography. More particularly, aspects of the present disclosure are directed to the fabrication of microneedle devices using a biocompatible polymer (biopolymer) by way of biocompatible, essentially biocompatible, or substantially biocompatible fabrication techniques.

Abstract: A barrel adapter for a syringe having a barrel and plunger. The adapter comprises a barrel tip and a needle retraction mechanism having a needle subassembly with a needle and a lumen, actuator subassembly, and biasing member. The needle subassembly moves from an injection to a retracted position within the barrel tip. The actuator subassembly includes a retainer connected to the barrel tip, a stylet held in a stylet disc, and a prong passing into the retainer. The stylet slides within the needle lumen and is spaced from the needle tip in the injection position. The biasing member biases the NOM from the retainer. A locking arrangement compresses the biasing member when locked and releases the biasing member when actuated by depression of the plunger, which moves the prong against the retainer. The biasing member moves the needle and stylet from the injection position to the retracted position when released.

Abstract: Various embodiments of a pelvic treatment system and method are provided. The present invention can include one or more drug eluting darts or barbs that are lodged into the wall and will elute the drug over a desired time period (weeks, months for example) to treat OAB, BPH, tissue weaknesses, or other disorders or diseases.

Abstract: The present invention comprises a deformable, implantable subcutaneous port for anchoring a transcutaneous treatment component. A port body portion having a normal area port footprint is adapted by means of a port orifice for receiving and anchoring the transcutaneous treatment component beneath the point of entry into the physiology of a patient and for routing the transcutaneous treatment component. The port body portion is produced from a deformable material and has structure and/or composition that provides deformability characteristics of the port such that collapsing, folding, stretching, elongating and/or twisting the port body portion into a modified port shape having a reduced-size port profile enables removal of the port body portion from the physiology of a patient through a relatively small transcutaneous opening.

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, a proximal end, and a distal end including a male luer tip having a central flow diverter extending outwardly from the central axis of the lumen 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: An electrode sheet attachable to living tissues is provided. The electrode sheet includes a hydrogel, a non-metallic conductive filler dispersed in the hydrogel, and a pharmaceutical or cosmetic transdermal component dispersed in the hydrogel.

Abstract: A method for implanting a wireless neural stimulator device, the method including: inserting a device through on a patient's skin on a posterior side of the patient's neck region, wherein the device includes a proximal end, a distal end, a first opening at the proximal end, a second opening at the distal end, and a lumen extending between the first opening and the second opening; after inserting the device through the patient's skin, advancing the distal end into the epidural space of the patient; inserting the wireless neural stimulator device through the first opening; advancing the wireless neural stimulator from the first opening through the lumen until the wireless neural stimulator exits the second opening and into the patient's epidural space; and advancing the wireless neural stimulator through the epidural space until a target site is reached.

Abstract: Disclosed herein are systems and methods for nerve conduction block. The systems and methods can utilize at least one renewable electrode. The methods can include delivering a first direct current with a first polarity to an electrode proximate nervous tissue sufficient to block conduction in the nervous tissue. Delivering the first direct current can place the nervous tissue in a hypersuppressed state at least partially preventing conduction of the nervous tissue after cessation of delivering of the first direct current. The nervous tissue can be maintained in the hypersuppressed state for a desired period, such as at least about 1 minute.

Abstract: The invention contemplates, inter alia, the use of remote ischemic conditioning in the treatment of cancer, neurodegenerative disorders, and gastrointestinal disorders, among others.

Abstract: The present specification discloses devices and methodologies for the treatment of GERD. Individuals with GERD may be treated by implanting a stimulation device within the patient's lower esophageal sphincter and applying electrical stimulation to the patient's lower esophageal sphincter, in accordance with certain predefined protocols. The presently disclosed devices have a simplified design because they do not require sensing systems capable of sensing when a person is engaged in a wet swallow, have improved energy storage requirements, enable improved LES function while concurrently delivering additional health benefits, and enable improved LES function post stimulation termination.

Abstract: A control device for an electrical stimulation apparatus according to the present disclosure includes a control section that adjusts an output of an electrode and communicates with an angular velocity detector, the electrode giving electrical stimulation to a predetermined part of a body doing a pedaling exercise by rotating a crank, the predetermined part being at least one of a leg and an arm, the angular velocity detector detecting an angular velocity of the predetermined part, the angular velocity being accompanied by an operation of the predetermined part during the pedaling exercise. The control section adjusts, according to a result of the detection in the angular velocity detector, an output timing of the electrical stimulation of the electrode such that the electrode gives electrical stimulation to the predetermined part when a state of the operation of the predetermined part during the pedaling exercise is a predetermined operation state.

Abstract: Apparatus is provided including an implantable retinal stimulator, for implantation on a retina of an eye, and including (i) an electrode array including electrodes; (ii) a plurality of photosensors; and (iii) driving circuitry, configured to drive the electrodes to apply currents to the retina. The apparatus further includes an interface member disposed at an outer surface of the implantable retinal stimulator, e.g., a peripheral member surrounding at least a portion of the implantable retinal stimulator. The apparatus additionally includes a frame, (i) shaped and sized to couple to the peripheral member and to surround the implantable retinal stimulator at least in part, and (ii) shaped to define at least a first anchoring element receiving portion. An anchoring element is shaped and sized to be positioned in the anchoring element receiving portion and to penetrate scleral tissue of the subject. Other applications are also described.

Abstract: A neural sensing method includes the steps of: configuring an array of sensing units on a retina of a user, each of the sensing units detecting a signal and generating a sensed signal; generating a control signal by a control signal generator and transmitting the control signal to at least one electrode installed in a periphery of each of the sensing units; isolating each of the sensed signals by the control signal, thereby suppressing the mutual interference between the sensed signals by the control signal; and generating and outputting a processed signal to at least one neuron via a signal processing module with reference to the control signal and the sensed signals. The control signal has a signal strength lower than the sensing threshold of the at least one neuron.

Abstract: Methods and apparatus are provided for renal neuromodulation using a pulsed electric field to effectuate electroporation or electrofusion. It is expected that renal neuromodulation (e.g., denervation) may, among other things, reduce expansion of an acute myocardial infarction, reduce or prevent the onset of morphological changes that are affiliated with congestive heart failure, and/or be efficacious in the treatment of end stage renal disease. Embodiments of the present invention are configured for extravascular delivery of pulsed electric fields to achieve such neuromodulation.

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

Abstract: In some examples, controlling delivery of CRT includes delivering ventricular pacing according to a sequence of different values of at least one of A-V delay or V-V delay, and acquiring one or more electrograms from respective vectors. For each of the different values of the at least one of A-V delay or V-V delay, at least one of a QRS amplitude or a QRS area may be determined based on the one or more electrograms, and a target change in QRS amplitude or QRS area between adjacent ones of the values of the at least one of A-V delay or V-V delay of the sequence may be identified. In response to the identification of the target change, the implantable medical device may deliver the ventricular pacing at a value of the at least one of A-V delay or V-V delay determined based on the identification to provide CRT.

Abstract: Computer implemented methods and systems are provided for automatically determining capture thresholds for an implantable medical device equipped for cardiac stimulus pacing using a multi-pole left ventricular (LV) lead. The methods and systems measures a base capture threshold for a base pacing vector utilizing stimulation pulses varied over at least a portion of an outer test range. The base pacing vector is defined by a first LV electrode provided on the LV lead and a second electrode located remote from an LV chamber. The methods and systems designate a secondary pacing vector that includes the first LV electrode and a neighbor LV electrode provided on the LV lead. The methods and systems further define an inner test range having secondary limits based on the base capture threshold, wherein at least one of the limits for the inner test range differs from a corresponding limit for the outer test range.

Abstract: A system and method for controlling non-paresthesia stimulation of neural tissue of a patient. The method delivers a non-paresthesia stimulation waveform, senses sensory action potential (SAP) signals from the neural tissue of interest, and analyzes the SAP signals to obtain SAP activity data for at least one of an SAP C-fiber component or an SAP A-delta fiber component. The method determines whether the SAP activity data satisfies a criteria of interest and adjusts at least one of the therapy parameters to change the non-paresthesia stimulation waveform when the SAP activity data does not satisfy the criteria of interest.

Abstract: A filtering algorithm implemented by a filtering module in an implantable medical device (IMD), or in an external device for communicating with an IMD, is disclosed which reviews blocks based on a number of rules. The filtering module preferably comprises both firewall and instruction analysis modules. The instruction analysis module analyzes the instructions and associated data (if present) in each block to determine whether such blocks would compromise operation of the IPG or injure a patient if executed. Instruction rules corresponding to an instruction identified in the block are retrieved by the instruction analysis module. The instruction analysis module reviews the block per the retrieved rules, and possibly also in light of current and historical IPG therapy setting or mode data, or other received but un-executed blocks. If a block is compliant, it is executed by the IMD or transmitted to the IMD.

Abstract: An insulative feedthrough attachable to an active implantable medical device includes a feedthrough body having a material which is both electrically insulative, biocompatible and separates a body fluid side from a device side. A passageway is disposed through the feedthrough body. A composite conductor is disposed within the passageway and has a body fluid side metallic wire electrically conductive to a device side metallic wire. The body fluid side metallic wire extends from a first end disposed inside the passageway to a second end on the body fluid side. The device side metallic wire extends from a first end disposed inside the passageway to a second end on the device side. The body fluid side metallic wire is hermetically sealed to the feedthrough body. The body fluid side metallic wire is biocompatible and is not the same material as the device side metallic wire.

Abstract: A feedthrough subassembly is attachable to an active implantable medical device. A via hole is disposed through an electrically insulative and biocompatible feedthrough body extending from a body fluid side to a device side. A composite fill partially disposed within the via hole extends between a first and a second composite fill end. The first composite fill end is disposed at or near the device side of the feedthrough body. The second composite fill end is disposed within the via hole recessed from the body fluid side. The composite fill includes a first portion of a ceramic reinforced metal composite including alumina and platinum and a second portion of a substantially pure platinum fill and/or a platinum wire. A via hole metallization covers a portion of the second composite fill end. A metallic leadwire is at least partially disposed within the via hole and gold brazed via hole metallization.

Abstract: Apparatus and methods which enable the stimulation of neurons oriented in all directions within a biological structure using applied magnetic fields.

Abstract: Provided is a negative ion emitting product and a method of forming the same. The negative ion emitting product comprises a silicone substrate and a separate silicone insert or patch material containing a negative ion emitting source. The separate silicone insert or patch material is attached to a surface of said substrate or inserted into a space defined by a wall of said substrate. The product is designed to be worn by a human or animal and preferably comprises a bracelet, necklace, collar, watch strap, shoe insole or the like. It particularly comprises a double molded silicone product containing in the patch or insert material, but not the substrate, nano-particles of negative ion radiating rare earth powder.

Abstract: Provided are methods and systems for treating or preventing dry eye syndrome in a subject. The methods involve applying light of a set of photomodulating parameters to the region of the eyelid. The light of these particular photomodulating parameters will increase the production of collagen, elastin or both thereby improving the tone of the eyelid. Improved eyelid tone will increase the level of meibum secreted through the meibomian duct thereby treating or preventing dry eye syndrome. Particular apparatuses are provided that emit and locate light of the necessary photomodulating parameters tailored for delivery to the eyelid areas activating fibroblasts specifically in this area and thereby improving eyelid tone and meibomian gland function.

Abstract: Disclosed is a therapeutic lamp platform inductive mask and charger. According to an exemplary embodiment of this disclosure, provided is a phototherapy system comprising a phototherapy device including a plurality of radiant lamps disposed to communicate radiant energy to a user treatment area, a rechargeable power source, and a controller operatively associated with controlling a delivery of the radiant energy to the user treatment area, wherein the plurality of radiant lamps, the rechargeable power source and controller are housed by a mask shaped therapeutic lamp platform wherein the phototherapy device is configured to inductively charge the rechargeable battery; and an inductive charger configured to charge the phototherapy device rechargeable battery.

Abstract: In one aspect, the present invention relates to a wound-care assembly The wound-care assembly includes a base layer. A film layer is operatively coupled to the base layer and a fluid conductor is in fluid communication with a wound and a vacuum source. The wound-care assembly further includes a fiber-optic patch comprising a plurality of fiber-optic strands. The fiber-optic strands are pressed into contact with an interior surface of the wound by the fluid conductor. The fiber-optic patch provides ultraviolet light to the wound and the relative vacuum is applied to the wound via the vacuum source and the fluid conductor.

Abstract: An apparatus to promote regrowth of eyebrow hair comprises a frame, and a set of temples to enable the apparatus to be worn on the forehead of a user. The apparatus includes a central member with a nosepiece, the central member being attached to one or more light hubs. Each light hub includes a plurality of light sources, and the light sources are configured to emit light onto a portion of a user's head. A head piece component attached to the central member top extends over the user's head. Light emitted by the light sources has a wavelength ranging from about 600 nanometers to about 1200 nanometers. The apparatus includes an adjustment mechanism that enables the interpupillary distance between the light hubs to be adjusted, and padding proximate the light hubs to provide a close fit between the light hubs and the user.

Abstract: Methods and devices for diagnosing, monitoring, and/or treating tissue through an opening or port through an airway wall. A passageway is created extending from the airway to the target tissue. The passageway provides local access to the target tissue for treatment instruments and for delivering agents.

Abstract: The invention provides a photodynamic therapy-based method for treating ocular glaucoma. A photosensitizer, for example, a benzoporphyrin derivative photosensitizer, is administered to a mammal either having or at risk of developing ocular glaucoma. The photosensitizer, when present in the ciliary body, is activated by light, for example, light from a laser. The treatment results in a reduction of intraocular pressure within the treated eye, which can persist for a prolonged period of time.

Abstract: A system and method for light stimulation within a medium. Products, compositions, systems, and methods for modifying a target structure which mediates or is associated with a biological activity, including treatment of conditions, disorders, or diseases mediated by or associated with a target structure, such as a virus, cell, subcellular structure or extracellular structure. The methods may be performed in situ in a non-invasive manner by application of an initiation energy to a subject thus producing an effect on or change to the target structure directly or via a modulation agent. The methods may further be performed by application of an initiation energy to a subject in situ to activate a pharmaceutical agent directly or via an energy modulation agent, thus producing an effect on or change to the target structure. Kits containing products or compositions formulated or configured and systems for use in practicing these methods.

Abstract: A device for delivery of a radiopharmaceutical and, in some embodiments, delivery of a pharmaceutical agent are described herein. Various other components for delivery systems including tubing management systems, primer caps, diffusion chambers, radiation shields and syringe shields, and other devices and methods are also described.