Abstract: A device for securing an oral airway device in place with a patient's oral cavity. The device comprises a V-clamp which is slid along its upper edge in the direction of the oral airway device. After making contact with the oral airway device with the V-clamp, the user may choose to manipulate a screw disposed on the device and bring its corresponding distal end into physical contact with the opposing surface or side of the oral airway device, thereby creating a compressive force on the oral airway device. Alternatively, the device may comprise a V-clamp on a first portion which is disposed on a sliding track. The first portion may be manipulated with the addition of a screw in order to create a compressive force on the oral airway device. Alternatively, the device may comprise two rotating portions coupled together via a pivot point.

Abstract: A medical tube holder, for securing a tube relative to a patient, comprises an elongate patient engaging portion for passing around at least a part of a neck and mouth region of a patient; a tube holding portion, connected to the patient engaging portion, for passing around at least a part of a medical tube; a tube-holding-portion securing arrangement for securing the tube holding portion around at least a part of the medical tube so that the medical tube can be securely positioned relative to the patient; and a patient-engaging-portion securing arrangement for securing the patient engaging portion around the patient's neck and mouth region to secure the medical tube holder to the patient. The patient-engaging-portion securing arrangement has a tightening arrangement to facilitate tightening of the patient engaging portion around the patient's neck and mouth region, and a locking arrangement that prevents loosening of the patient engaging portion while allowing further tightening.

Abstract: In one embodiment, a nasal cannula is shaped to fit within a user's nares, where the nasal cannula includes at least one prong allowing high flow delivery of humidified gases and creates positive airway pressure in the patient's airway. The prongs have angled ends such that, in use, gases flowing through the prongs are directed to the user's nasal passages. The nasal cannula body is partially swiveling and preferably has a ball joint connector. In another embodiment the nasal cannula may have at least one flared end prong that preferably seals within a patient's nare.

Abstract: Headgear for use with a respiratory mask is described. The headgear comprises a continuous and substantially curved elongate member extending in use below a user's nose and at least two headgear straps capable of attachment to the ends of the elongate member. A mask attachment on the elongate member is disposed to sit below or on one of said user's nose, mouth, upper lip and an inlet to the mask. The attachment is capable of receiving the mask.

Abstract: A patient interface has a single loop headstrap and a mask for covering at least the nostrils of the user. The single loop headstrap extends from the mask at either end. A short length of supple conduit is coupled to the mask by a swivel or ball joint to allow rotation of the conduit relative to the mask through different angles and orientations.

Abstract: A respiratory mask assembly for delivering breathable gas to a patient includes a frame and a headgear assembly removably attachable to the frame. The headgear assembly includes a pair of side portions and a rear portion that interconnects the pair of side portions. The pair of side portions includes at least one strap. The rear portion has at least one strap constructed of at least two layers of material. One of the layers of material has a more rigid construction than the other of the layers of material to resist compression of the at least one strap of the rear portion in a first direction which resists movement of the at least one strap of the pair of side straps in the first direction.

Abstract: An oxygen face mask and component system is provided, the mask is designed to cover a user's nose and at least partially cover a user's mouth, the mask having lateral ports. Systems and assemblies including such a face mask and additional components are further provided, including a colorimetric CO2 detector, a sealing cap with or without a resilient sealing flap, a capnography gas analysis unit, a non-rebreather valve, a pulmonary function module, nebulizer, a gas scavenging system, a gas reservoir system, a gas filter, sample lines that are either straight or at an angle, and an aerosol mask platform; and methods of making and using such a face mask are also provided.

Abstract: A system for generating nitric oxide can include an apparatus positioned in a trachea of a mammal, the apparatus including a respiration sensor for collecting information related to one or more triggering events associated with the trachea, an oxygen sensor for collecting information related to a concentration of oxygen in a gas, and one or more pairs of electrodes for initiating a series of electric arcs to generate nitric oxide, and the system for generating nitric oxide can also include a controller for determining one or more control parameters based on the information collected by the respiration sensor and the oxygen sensor, wherein the series of electric arcs is initiated based on the control parameters determined by the controller.

Abstract: An apparatus and method to reduce or eliminate stimming behavior by placing a viewing aperture in front of the user. This reduces visual stimulation by limiting what can be seen. After repeated use with the present invention and interactive mediums, new neural pathways are formed in the brain, which cause the reduction or elimination of stimming behavior.

Abstract: A sound generation system with two audio channels for treating psychological/psychiatric and neurological disorders, comprising means (G/M, MD, DC, M/G MX) for generating two first audio signals, one for each audio channel (Ch1, Ch2), wherein each first signal is a random noise, and wherein the two first signals are not correlated to each other and define a relative reference sound level. The generation system comprises means (G/M, MD, DC, MX) for adding to both the first signals a second signal at a sound level having amplitude between +/?12 dB with respect to the relative reference sound level.

Abstract: A catheter and package combination including a package having opposed front and rear panels that are sealed together to define a sealed interior cavity. The package also has top and bottom edges and opposed side edges. The cavity has a first height extending in a direction between the top and bottom edges. The front and rear panels are configured to tear adjacent to one of the side edges in the direction between the top and bottom edges to form an opening in communication with the cavity wherein the opening has a second height in the direction between the top and bottom edges that is smaller than the first height of the cavity. A urinary catheter in a compact configuration is disposed within the cavity.

Abstract: A catheter for delivering, a hyperthermic liquid to the interior of an organ of a patient includes an inflow lumen structured to be inserted into the organ and deliver the hyperthermic liquid to the interior of the organ, and an outflow lumen structured to be inserted into the organ and evacuate the hyperthermic liquid from the interior of the organ. The catheter includes a proximal portion that is structured to be received within the internal tissue structure of the patient, wherein at least a portion of the inflow lumen and the outflow lumen are insulated in a manner wherein a temperature on an outside surface of the proximal portion of the catheter will not be more than one degree Fahrenheit above normal body temperature when the hyperthermic liquid is passed through the catheter.

Abstract: A dialysis catheter including a first portion having an outer wall having a first diameter, an elongated distal portion having a second diameter smaller than the first diameter, and a transition region between the first portion and distal portion. A first longitudinally extending venous lumen is configured to deliver blood. First and second independent longitudinally extending arterial lumens are configured to withdraw blood from a patient. The venous lumen and arterial lumen have first and second regions each positioned a first distance from the outer wall of the catheter and a third region positioned a second shorter distance from the outer wall of the catheter to form an arch shaped wall portion progressively increasing in thickness from the third region toward the first region and from the third region to the second region.

Abstract: Methods and systems for regenerating damaged tissue rely on direct injection of selected therapeutic cells into a tissue at or near the site of tissue damage. Direct injection is accomplished using an intravascular catheter having a deployable needle, and injection is usually targeted into the adventitial and peri-adventitial tissues surrounding the blood vessel from which the needle is deployed.

Abstract: A compact catheter assembly (10) and methods of making such a catheter assembly are disclosed. The catheter assembly includes a receiver (14) and a catheter sub-assembly (16). The catheter sub-assembly includes a gripping member (18) and a catheter tube (20) carried by the gripping member.

Abstract: A medical device control handle or catheter includes deflection assembly and at least one of the following: a disk actuator, a lever actuator and a ring actuator for actuating additional puller wires in manipulation of multiple features of the medical device or catheter independently of each other. The disk actuator has a common rotational axis with but is rotationally independent of the deflection assembly. The lever actuator has a separate rotational axis. The ring is mounted outside of the control handle and rotatable relative to the control handle to actuate another puller wire for manipulating another feature of the catheter. Each of the disk, lever and ring actuators are of a design that allows existing control handles and catheters to be readily modified to include these actuators.

Abstract: Devices and methods for providing an elastically deforming guidewire tip, capable of withstanding the extreme forces of high-speed rotational atherectomy, in particular orbital motion induced by an eccentric abrasive head, are disclosed. In certain embodiments, the reformable tip comprises an inner nitinol support coil, wherein the reformable tip may be attached to a larger proximal core for improved kink resistance and support for delivering adjunctive devices. In other embodiments, an inner nitinol support coil may be wrapped with a braided coil and/or a polymer sleeve. The resulting tip is more flexible with reduced risk of perforation than known guidewire tips.

Abstract: An elongate flexible steerable guidewire for facilitating placement of a medical implement is described having a proximal section, an intermediate section, and a distal steerable section. In embodiments the distal steerable section comprises a rotatable swivel member, and an elongate directional tip extending distally from the swivel member. At least one manipulation wire is secured to the swivel member and extends proximally to the proximal section. Axial movement of manipulation wires rotates the swivel member, thereby deflecting the directional tip. An actuator or handle may be incorporated with the guidewire. Methods include placing medical implements in target regions. Exemplary applications include guiding and placement of electrical leads in the spine, and placement of angioplasty devices in the vasculature.

Abstract: A mechanism can include a step feature guidewire having a guidewire with a proximal end, a distal end, and a diameter. A self-expanding element can be disposed approximate to the distal end of the guidewire and can have at least two states which include a contracted diameter and an expanded diameter. The self-expanding element can be expandable under its inherent proprieties, based at least on its original shape and the nature of the materials that make up the element. Further, the expanded diameter can be approximately 70% to 280% of the guidewire diameter. While the guidewire is designed for passing through a body lumen while treating a patient, the expanded diameter is less than any body lumen diameter the guidewire is determined to pass through.

Abstract: The present disclosure provides a cutting edge cutting catheter and a method for treatment of peripheral chronic total occlusion (“CTO”) in a body vessel. The cutting edge cutting catheter has an arcuate cutting edge slidably disposed within an elongate member or catheter. A tension mechanism connects to the cutting edge and applies a tension to move the cutting edge between a bent state and a straight state. An expandable balloon surrounds the elongate member to dilate the occluded body vessel and ablate the occlusion.

Abstract: A catheter for treatment of sinusitis capable of causing a space in a further rear (distal side) of a posterior nasal aperture to communicate with external air is provided. The catheter comprises an anterior nasal aperture balloon 33, an anterior nasal aperture balloon air supply lumen 39b for inflating the anterior nasal aperture balloon 33, a posterior nasal aperture balloon 13, a posterior nasal aperture balloon air supply lumen 19b for inflating the posterior nasal aperture balloon 13, and a drainage lumen 39a having an opening 41 between the anterior nasal aperture balloon 33 and the posterior nasal aperture balloon 13, in which an external air communication lumen 19a having an opening 21 on a distal side from the posterior nasal aperture balloon 13 is further provided.

Abstract: A device and system for flushing a shunt catheter utilizes the available cerebrospinal fluid (CSF) to flush a blocked catheter. The CSF is pressurized to a predetermined amount and then allowed to suddenly, rapidly and forcefully purge any occlusions. The rapid release of CSF produces flow jets from the catheter pores into the ventricle. This impulse, or “cough”, will push and divert choroid plexus and/or other blockages away from the pores. The device and system may then be allowed to refill at a slow rate, thus reducing the possibility of rapid suction of fluid back into the system and the attendant possibility of drawing the choroid plexus back into the pores. The catheter at the proximal end may also include back-up pores that can be opened to restart flow from the ventricle should the primary pores remain blocked after a flushing attempt.

Abstract: A medication delivery device for treatment of a pulmonary disorder in a patient includes an elongate member, an expandable member is coupled to a distal end of the elongate member, and an agent delivery portion coupled to an external surface of the expandable member. The agent delivery portion includes an agent that disrupts nerve activity.

Abstract: A method of treating a sinus cavity of a subject includes advancing a distal portion of a light source through a drainage pathway of a sinus cavity and into the sinus cavity and visually observing a transdermal light emitted from the light source. A distal portion of a substantially rigid inner guide member of a balloon dilation catheter is advanced into the drainage pathway, the balloon dilation catheter including a movable shaft including a balloon that is slidably mounted on the substantially rigid inner guide member. The movable shaft and balloon are advanced distally over the substantially rigid inner guide member to place a portion of the balloon in the drainage pathway whereby the balloon is inflated.

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

Abstract: A device implantable in tissue of a prostate gland or a bladder is described. The device includes a device body, a retrieval portion, a medicament, and a medicament carrier. The device body includes a first end and a second end opposite of the first end. The first end has a sharp tip adapted for penetrating the tissue. The retrieval portion connected to the second end of the device body. The medicament is applied to the device to therapeutically treat the prostate gland or the bladder. The carrier is a hydrogel, a silicone based material, an elastomer, a proteinaceous material, a polyethylene glycol material, a carbohydrate material, or a polysaccharide carbohydrate material that provides controlled delivery of the medicament over a duration of time.

Abstract: A method for producing an acicular body having a support base and an acicular protrusion on one surface of the support base includes supplying an acicular body-forming liquid, in which an acicular body-forming material is dissolved or dispersed in a solvent, to an intaglio plate having a recess corresponding to a protrusion, under a first pressure environment of not more than 0.05 MPa, changing the first pressure environment of the acicular body-forming liquid supplied to the intaglio plate to a second pressure environment of higher than 0.05 MPa, drying the acicular body-forming liquid supplied to the intaglio plate such that an acicular body is formed, and peeling the acicular body from the intaglio plate.

Abstract: A valve for a needleless valve system. The valve includes a body configured to be disposed in the needleless valve system and controlling fluid flow through the needleless valve system and wherein the body is tail-less. The body includes a continuous top surface, and a compression feature configured to control how the body is compressed to allow fluid flow through the needleless valve system.

Abstract: The present invention relates to a reinforcement means (400) for a lead (300), especially a lead (300) for neural applications, preferably a lead (300) for a neurostimulation and/or neurorecording system, wherein the reinforcements means (400) has at least predetermined and/or customizable bending motion capabilities and/or is configured such that the minimum bending radius of the lead (300) is at least partially limited. Furthermore, the present invention relates to a lead, a neurostimulation and/or neurorecording system and an interlocking annular element for a reinforcement means.

Abstract: A stimulation lead includes a lead body having a longitudinal length, a distal portion, and a proximal portion; terminals disposed along the proximal portion of the lead body; an electrode carrier coupled to, or disposed along, the distal portion of the lead body; segmented electrodes disposed along the electrode carrier; and conductors extending along the lead body and coupling the segmented electrodes to the terminals. The electrode carrier includes a lattice region defining segmented electrode receiving openings. Each of the segmented electrodes extends around no more than 75% of a circumference of the lead and is disposed in a different one of the segmented electrode receiving openings of the electrode carrier.

Abstract: An implantable medical device assembly comprises a sealed housing; a motor including a rotating output shaft within the sealed housing; a first coaxial shaft within the sealed housing, the first coaxial shaft being mechanically coupled to the rotating output shaft such that rotation of the rotating output shaft drives rotation of the first coaxial shaft; a second coaxial shaft external to the sealed housing, the second coaxial shaft being in axial alignment with the first coaxial shaft; an oscillating component mechanically coupling the first coaxial shaft to the second coaxial shaft, wherein rotation of the rotating first coaxial shaft drives the oscillation of the oscillating component, wherein the oscillation of the oscillating component drives rotation of the second coaxial shaft; and a flexible seal including the oscillating component. The sealed housing and the flexible seal combine to form a substantially sealed enclosure encasing the motor and the first coaxial shaft.

Abstract: A method and apparatus for the concurrent treatment of multiple oral diseases and defects while promoting general oral hygiene utilizing direct current electricity. Electrodes are used to deliver a direct current to the gingival tissues of a mouth in order to achieve a number of therapeutic, prophylactic, and regenerative benefits. These benefits include killing oral microbes, increasing oral vasodilation, reducing oral biofilm, improving oral blood circulation, reversing oral bone resorption, promoting oral osteogenesis, treating gum recession, and fostering gingival regeneration. Other benefits include the treatment of gingivitis, periodontitis, and oral malodor, and other systemic diseases correlated with oral pathogens.

Abstract: An insulative body of a medical electrical lead electrode assembly includes a pre-formed channel having a section extending at an angle to a longitudinal axis of the body. An electrode portion of a conductive component has an electrode contact surface facing outward from a first side of the body and a coupling portion embedded in the body. A conductor, which is coupled to the coupling portion of the component, is disposed in the channel.

Abstract: An electro catheter for neurostimulation includes a stimulation end of essentially helical shape, suited to be wrapped around a nerve. The stimulation end is deformable, meaning that it has a helical shape that can be modified in diameter and/or pitch, according to the dimensions of the nerve to be wrapped, and can be modified even to the point of assuming an essentially rectilinear linear shape according to the profile of the nerve, so that it is suited to be positioned in proximity to the nerve, along its profile.

Abstract: The invention contemplates, inter alia, the use of remote ischemic conditioning in the treatment of a variety of disorders.

Abstract: The application relates to a hearing assistance system (a method and its use) for processing an input signal representative of sound according to a user's needs, the hearing assistance system comprising an implanted part adapted for being at least partially implanted in a user's head and comprising a sensing unit capable of measuring an endocochlear potential at one or more positions along the length of the cochlear partition. The hearing assistance system further comprises a decoder configured to receive said endocochlear potentials or signals derived therefrom and to transform the received signals into signals appropriately conditioned for use as control inputs to the signal processing unit, and wherein the signal processing unit is configured to process the electric input signal in dependence of said control inputs from said decoder. Thereby the processing of the audio signal of a hearing assistance device can be automatically adapted over time.

Abstract: A high channel count high-voltage neural stimulator provides an external circuit which communicates power and data to a neural stimulator implant circuit. Data from the external device, such as image data from a camera in an epiretinal application, are communicated to the implant. Multiple pixels circuits, within each implant demultiplex the digital signals, then output separate nerve stimulator outputs from multiple outputs, each configured for connection to a nerve, by sharing a single level conversion driver circuit. In at least one example, the implant circuits can be clustered in a master-slave configuration to increase the number of available neural stimulation outputs.

Abstract: Systems and methods for administering spinal cord stimulation (SCS) based on temporal patterns of electrical stimulation are disclosed. According to an aspect, a method includes using a computational model of a wide-dynamic range (WDR) neuron to determine one or more non-regular temporal patterns that results in predetermined WDR neuronal output and stimulation activity for one of efficacy optimization and efficiency optimization. The method also includes administering to a subject spinal cord stimulation based on the determined one or more of the non-regular temporal patterns.

Abstract: Some implementations provide a method for treating craniofacial pain in a patient, the method including: placing a wirelessly powered passive device through an opening into a target site in a head or neck region of the patient's body, the wirelessly powered passive device configured to receive an input signal non-inductively from an external antenna; positioning the wirelessly powered passive device adjacent to or near a nerve at the target site; and causing neural modulation to the nerve through one or more electrodes on the wirelessly powered passive device.

Abstract: Medical device systems and methods with multiple communication modes. An example medical device system may include a first medical device and a second medical device communicatively coupled to the first medical device. The first medical device may be configured to communicate information to the second medical device in a first communication mode. The first medical device may further be configured to communicate information to the second medical device in a second communication mode after determining that one or more of the communication pulses captured the heart of the patient.

Abstract: The present invention relates generally to the materials and methods for improving the wettability of an implantable medical device. More specifically, the invention relates to devices and methods for coating at least a portion of a medical device to improve wettability and reduce electrical impedance. Given the challenges of maintaining consistent and predictable electrical characteristics as implantable medical devices become smaller in size, there remains a continual need to improve wettability in an effort to improve medical outcomes.

Abstract: An implantable medical device (IMD) automatically determines at least a portion of the parameters and, in some instances all of the parameters, of an exposure operating mode based on stored information regarding sensed physiological events or therapy provided over a predetermined period of time. The IMD may configure itself to operate in accordance with the automatically determined parameters of the exposure operating mode in response to detecting a disruptive energy field. Alternatively, the IMD may provide the automatically determined parameters of the exposure operating mode to a physician as suggested or recommended parameters for the exposure operating mode. In other instances, the automatically determined parameters may be compared to parameters received manually via telemetry and, if differences exist or occur, a physician or patient may be notified and/or the manual parameters may be overridden by the automatically determined parameters.

Abstract: A system for treating chronic inflammation may include an implantable microstimulator, a wearable charger, and optionally an external controller. The implantable microstimulator may be implemented as a leadless neurostimulator implantable in communication with a cervical region of a vagus nerve. The microstimulator can address several types of stimulation including regular dose delivery. The wearable charger may be worn around the subject's neck to rapidly (<10 minutes per week) charge an implanted microstimulator. The external controller may be configured as a prescription pad that controls the dosing and activity of the microstimulator.

Abstract: Systems and methods for communicating between medical devices. In one example, an implantable medical device comprising may comprise one or more electrodes and a controller coupled to the electrodes. The controller may be configured to receive a first communication pulse at a first communication pulse time and a second communication pulse at a second communication pulse time via the one or more electrodes. The controller may further be configured to identify one of three or more symbols based at least in part on the time difference between the first communication pulse time and the second communication pulse time.

Abstract: Systems and methods for communicating between medical devices. In on example, a medical device comprises a communication module for communicating with an implantable leadless cardiac pacemaker through body tissue and a controller operatively coupled to the communications module. The controller may be configured to: identify intrinsic heartbeats; provide a blanking period after each occurrence of an intrinsic heartbeat; and communicate with the implantable leadless cardiac pacemaker via the communication module only during times between the blanking periods.

Abstract: Systems and methods for communicating between medical devices. In one example, a method for communicating between a plurality of medical devices in a medical device system comprises, with a first medical device, communicating a first message to a second medical device. The method further comprises, with the second medical device, receiving the first message, wherein the first message comprises a plurality of communication pulses. A first set of the plurality of communication pulses represent a synchronization portion of the first message. A second set of the plurality of communication pulses represent a relative device address portion of the first message. A third set of the plurality of communication pulses represent a command portion of the first message. A fourth set of the plurality of communication pulses represent a payload portion of the first message.

Abstract: Systems and methods for communicating between medical devices. In one example, an implantable medical device comprises a communication module configured to receive commands from other medical devices, wherein the commands include a relative address and a command payload; a memory unit that stores a relative address and a unique identifier of the implantable medical device; a processing module coupled to the communication module and the memory unit, the processing module configured to: determine whether the relative address of a received command matches the relative address stored in the memory unit of the implantable medical device; if the relative address of the received command matches the relative address stored in the memory unit of the implantable medical device, execute the received command; and if the relative address of the received command does not match the relative address stored in the memory unit of the implantable medical device, ignore the received command.

Abstract: A defibrillator includes: an impedance measuring section which is configured to obtain an impedance measurement value between a living body of a rescue target and electrodes; a controller which is configured to detect a kind of the electrodes, and which, based on the detected kind of the electrodes, is configured to perform determination of whether the impedance measurement value is to be output or not; and an outputting section which, based on the determination, is configured to output the impedance measurement value.

Abstract: Capacitor configuration for use in a subcutaneous implantable cardioverter defibrillator having a tubular shape, including a first plurality of high volumetric efficiency capacitors, each one of the first plurality of high volumetric efficiency capacitors having a disc shape, the first plurality of high volumetric efficiency capacitors being coupled in parallel and arranged in a stack as a first array of capacitors, thereby forming a cylindrically shaped capacitor.

Abstract: The present invention relates generally to the treatment of atherosclerosis and thrombosis. Specifically, the invention relates to a method for removing vascular deposits by locally heating plaque sites with micron size particles that are administered intravenously and are heated inductively.