Abstract: The present invention relates to a drug-eluting medical device, in particular a balloon for angioplasty catheters with drug elution to prevent the restenosis of the vessel subjected to angioplasty. More particularly, the present invention relates to a catheter balloon completely or partially coated with paclitaxel in hydrated crystalline form or in hydrated solvated crystalline form, having an immediate release and bioavailability of a therapeutically effective amount of paclitaxel at the site of intervention. The balloon can be made of a polyether-polyamide block copolymer, or a polyester amide, or polyamide-12.

Abstract: Various aspects of the present disclosure provide compositions, coatings and implantable devices including a drug and an excipient. In certain embodiments the excipient and the drug are present at a weight ratio of between 10 to 1 and 1 to 10 drug to excipient. In certain other embodiments, the excipient and the drug form particles in which the drug is encapsulated by the excipient. Other aspects of the disclosure provide methods of manufacturing and using such compositions, coatings and implantable devices.

Abstract: The present invention relates to drug-eluting articles with multiple polymeric coatings arranged and constructed to provide improved drug release profiles. Specifically, the present invention relates to drug-eluting articles that each comprises a substrate, a first polymeric layer over said substrate, and a second polymeric layer over said first polymeric layer. The first polymeric layer comprises at least a first biocompatible polymer and at least a first pharmacologically active compound that is encapsulated in the first biocompatible polymer. The second polymeric layer comprises at least a second biocompatible polymer having a degradability that is higher than that of the first biocompatible polymer.

Abstract: Disclosed is a system for the collection, processing and reuse of amniotic fluid and placental aspirate at a C-section site. The system includes a canister positioned along the vacuum line through which the amniotic fluid and placental aspirate is suctioned. The canister has a coil whereby the heavier cellular components, including stem cells, platelets and growth factors, are separated coincident with the surgical procedure. The canister has a port whereby the heavier cellular material can be removed from the canister. The heavier cellular material can be then applied to the wound site of the cesarean section patient. The system disclosed allows for the processing of the amniotic fluid and placental aspirate to take place in the same room as the surgical procedure. A kit and method are also provided.

Abstract: A body cavity drainage device placement tool for placing a body cavity drainage tube at least partially within a body cavity of a patient. The body cavity drainage device includes a shaft, a handle attached to or integral with a proximal end of the shaft, and a distal end of the shaft sized and configured for insertion through a lateral opening of the body cavity drainage tube and at least partially through a central lumen of the body cavity drainage tube to proximate a distal end of the body cavity drainage tube. Methods relate to using a body cavity drainage device placement tool.

Abstract: Sensors for catheter pumps are disclosed herein. The catheter pump can include a catheter assembly comprising a catheter and a cannula coupled to a distal portion of the catheter. The cannula can have a proximal port for permitting the flow of blood therethrough. The catheter assembly can include a sensor to be disposed near the proximal port. A processing unit can be programmed to process a signal detected by the sensor. The processing unit can comprise a computer-readable set of rules to evaluate the signal to determine a position of the cannula relative to an aortic valve of a patient.

Abstract: Blood pump devices having improved rotor design are provided herein. Such blood pump devices include rotors having cantilevered support through a sealed mechanical bearing disposed outside a blood flow path of the device so as to avoid thrombus formation caused by blood contact with the bearing. The bearing means can be rotatably coupled with a proximal portion of the rotor shaft extending outside the fluid path, while a stator drives rotation of the rotor shaft so that one or more rotor blades on a distal portion of the rotor force blood flow through the device. The bearing means may include one or more radial bearings on a proximal portion of the rotor shaft that are isolated from the blood flow path by one or more rotary seals.

Abstract: A blood pump system includes a first implantable housing, an implantable blood pump independent from the first implantable housing, and a percutaneous extension. The first implantable housing includes a rechargeable power storage device. The implantable blood pump supplements the pumping function of a heart. The rechargeable power storage device supplies electrical power to the implantable blood pump. The percutaneous extension is coupled to the rechargeable power storage device and adapted to traverse the skin. The percutaneous extension is configured to releasably connect to an external power supply adapted to provide power for recharging or supplementing the rechargeable power storage device to power the implantable blood pump.

Abstract: A blood pump, such as an axial flow pump, having a pump housing, the pump housing defining a flow path and having a tapered portion adjacent to an outlet, tapering toward the outlet, an outflow cannula connected to the outlet of the pump housing, and an impeller and diffuser, disposed in the pump housing, the diffuser having a tapered body corresponding to the tapered portion of the pump housing, the diffuser body having at least one vane extending therefrom, the vein tapering in the same direction as the diffuser body. The present invention also includes a method of manufacturing the blood pump and a method of implanting the blood pump.

Abstract: Provided is a filtration module for separating plasma from blood comprising a feeder channel lid, a feeder channel defined by a feeder channel laminating layer having a thickness of less than 5 mil, a filter element in fluid communication with the feeder channel and having a pore size of less than 2 microns and low surface area, and a filtrate take-off port having a dead volume of less than 10 ?I. Also provided is a method for filtering a blood sample comprising supplying the blood sample to a feeder channel of a filtration module and drawing the blood sample over a filter element of the filtration module in a single pass to provide a retentate and a plasma filtrate.

Abstract: A storage assembly is removably connectable to a drug delivery device. A first chamber is disposed in the housing. A plurality of penetrating members are stored in the first chamber. A second chamber is disposed in the housing for storing the plurality of penetrating members after being used in an injection. A transfer drum disposed in the housing transfers one of the penetrating members from the first chamber to an injection position and from the injection position to the second chamber following an injection.

Abstract: A system and method are provided for packaging and sterilizing analyte sensors. The packaging system provides a structure for securing the analyte sensors in a fixed position and fixed orientation within the package.

Abstract: An apparatus for treating a tennis elbow by percutaneous intervention, includes: a body having an actuating element, a fixing part arranged to fixably position the body, a positioning device connected to the body, including a positioning part moveable by the actuating element, a holder releasably connected to the positioning part, and including a top part for the releasable connection to the positioning part and a bottom part defining a support surface for supporting an elbow tendon region of a person to be treated, the support surface, the top and bottom parts being connected by one or more connecting members, the holder including a holder part with a number of penetration elements arranged thereon, wherein the top and bottom parts are spaced-apart at such a distance that, before penetration of the elbow tendon, the penetration tips of the penetration elements are covered by the bottom part.

Abstract: Ambulatory infusion pumps, pump assemblies, and baseplate assemblies, including cartridges, baseplates, cannulas, inserters, and related components and batteries therefor, as well as component combinations and related methods.

Abstract: A dosing device for an infusion system comprises a dosing unit having a variable volume and at least one opening in fluid connection with the variable volume, through which opening the variable volume can be filled with a substance or the substance can be dispensed from the variable volume. The dosing device is operable in a first state for filling the substance from a supply conduit, in a second state for preventing filling and dispensing, or in a third state for dispensing through a dispensing conduit. No direct fluid connection exists between the supply conduit and the dispensing conduit at any time. Methods for dosing a substance with the dosing device.

Abstract: Systems for use with a medical device for reducing medication errors are provided. In one aspect, a system includes a medical device that is configurable with operating limit parameters for providing medication to a patient, and a limiting system. The limiting system includes a memory that includes patient-specific information for the patient and a database includes acceptable operating parameters for providing the medication to the patient using the medical device, and a processor. The processor is configured to compare the acceptable operating parameters with the patient-specific information, and provide a modification of the operating limit parameters for providing the medication to the patient based on the comparison of the acceptable operating parameters with the patient-specific information. Methods and machine-readable media are also provided.

Abstract: Described herein are assisted syringes. The syringes provide a higher force to the plunger tip than the extrusion force applied to the plunger. The assisted syringes can be used to inject or extrude viscous materials.

Abstract: Embodiments of the shield assemblies include a shield that is pivotably secured to a needle hub. A ball-and-socket hinge secures the shield and the hub to one another. The assembly includes a reversible shield lock to hold the shield in the needle-protected position. The assembly further includes at least one stop piece to stop the shield from over-rotating.

Abstract: A process of manufacturing a sharps container and a method of storing needles are disclosed. The sharps container utilizes a blocking member which does not interfere with a needle being inserted into the sharps container, and a latch mechanism which does not require a protruding tab. The latch mechanism requires at least a dual action to open the sharps container, and limits the movement required for opening the sharps container.

Abstract: An infusion pump includes: a main body; a tube attachment section inside the main body; a liquid feed driving unit inside the main body; an access cover mounted on the main body and for covering the infusion tube when the infusion tube is attached to the tube attachment section when closed; and a bubble detection unit for detecting a bubble inside the infusion tube when the infusion tube is attached to the tube attachment section. The bubble detection unit includes a first member at the access cover and a second member at the main body.

Abstract: A self-contained apparatus and corresponding methods are provided for delivering viscous fluids in a controlled manner, such as delivering a viscous fluid in a surgical setting. The self-contained apparatus can include a motion following pressure regulator that allows for linear control of a regulated pressure. The regulated pressure can be used for dispensing a viscous fluid from a syringe that is coupled to the self-contained apparatus. The pressure regulator regulates a pressure derived from a pressurized fluid reservoir located at least partially within a housing of the apparatus. This allows the viscous fluid to be delivered using pressure to provide a driving force greater than a force easily delivered manually, while still allowing a surgeon to retain fine control over the rate of viscous fluid delivery.

Abstract: A nebulizer comprises a controller linked at its output to a nebulizer head, and at its input to a USB cable and USB plug for connection to a host system. The link between the USB plug and the controller is a USB cable with power and data channels. The controller comprises a boost circuit, a microcontroller 11, and a drive circuit. The latter provides power and control signals via a cable and proprietary plug to the nebulizer head. These signals provide power and control for a vibrating membrane receiving a liquid to be aerosolized. The controller has a housing with LED status lamps, and an ON/OFF button. The controller can be controlled via a host, either locally or remotely.

Abstract: A method of treatment for mixed carbon dioxide, carbonic acid, saline and optional active additives for treating lower body cavity ailments includes delivery of dosage of the treatment at specified flow rates, using a) main housing having a hollow central area containing the dosage; b) a dosage dispenser head located at the distal end of the main housing, and having at least one flow channel for movement of the dosage from the main housing through the dosage dispenser head and to external of the dosage dispenser head; c) a dosage release control component located between the main housing and the dosage dispenser head to permit flow of the dosage through the dosage dispenser head in response to increased pressure against the dosage; and d) a pressure-changing moveable component on the main housing.

Abstract: The traditions, studies and international practice, prove that the inhalation of hot steams with or without the impurity of a medicine, helps the prevention and treatment of respiratory system diseases in hospitalization or home treatment. The device of application of the therapy is simple, easy to use, safe and affordable cost. This invention concerns a system with: 1) A inventive pipe—conductor of air, with an embodied safe system of electric points and power connections—cables for the supply of the nebulizer device with air and power simultaneously. 2) A nebulizer device that permits the simultaneous heating of the solution and nebula at 35-40° C. via a temperature regulator. In addition it posses system which via the electromagnets or the mechanism opens and closes impellers or a silicone leaf and settles the provision of nebula towards the inhalation mask. 3) A mask of inhalations with conical channels that routes the expired air to the sensor and the inhaled nebula to the mouth and nasal cavity.

Abstract: A system and method suitable for monitoring user technique of an inhaler device configured for delivery of a medicament is provided. The system may include a microphone adapted for sensing sound made during operation of the inhaler device and processing circuitry operable to process a data signal obtained from the microphone, wherein the data signal includes acoustic information sensed. The processing circuitry is adapted to determine inhalation and exhalation breath characteristics that occur during use, by analyzing the temporal and spectral components of the acoustic information sensed and processed to differentiate between an inhalation and an exhalation, based on both the temporal and spectral components. This information can be processed to determine user technique adherence to inhaler or respiratory device protocol. The analysis of temporal and spectral components can determine the impact of user technique errors on the quantity and the deposition of medicament delivered into the user's airways.

Abstract: This disclosure describes systems and methods for providing novel back-up ventilation that allows the patient to trigger or initiate the delivery of breath. Further, this disclosure describes systems and methods for triggering ventilation when base flow is unknown or undeterminable by the ventilator.

Abstract: A control system (706) provides automated control of gas washout of a patient interface, such as a mask or nasal prongs. A gas washout vent assembly (60) of the system may include a variable exhaust area such as one defined by overlapping apertures of the assembly or a conduit having a variable gas passage channel. The vent assembly may be formed by nested structures, such as conic or cylindrical members, each having an opening of the overlapping apertures. The vent assembly may be attached substantially near or included with the patient interface. An actuator of the assembly, such as a solenoid or voice coil, manipulates an aperture of the vent assembly. The actuator may be configured for control by a controller to change the exhaust area of the vent assembly based on various methodologies including, for example, sleep detection, disordered breathing event detection, rebreathing volume calculation and/or leak detection.

Abstract: Disclosed is an apparatus for condensing water from respiratory gases. The apparatus has a heat exchange component having an inlet, an outlet and a condensation chamber, the inlet and outlet being connectable to a breathing system, such that respiratory gases are conveyed through the condensation chamber, in use, and a base unit adapted to aid removal of heat from the walls of the heat exchange component. The heat exchange component is releasably engageable with the base unit, such that the heat exchange component is replaceable.

Abstract: An oropharyngeal device positionable within an airway of a patient may include a hollow body having a proximal end positionable adjacent the patient's mouth and an opposite distal end positionable adjacent and spaced from the patient's epiglottis. The body includes a center channel extending from the proximal end to the distal end of the body. The oropharyngeal device may include a supply passage for delivering oxygen to the patient. The supply passage may include at least one of a discharge port fluidly connecting the supply passage to an exterior region of the oropharyngeal device and a discharge port fluidly connecting the supply passage to the center channel. The discharge ports may be positioned along a wall of the body between the distal and proximal ends. The oropharyngeal device may include a sensing passage for sampling a patient's respiratory composition positioned adjacent the distal end of the body.

Abstract: A method of providing a range of different sized masks for fitting to a patient includes providing a first mask having an upper lip engagement surface having a first concavity and a first nasal envelope and providing a second mask having an upper lip engagement surface having a second concavity different than the first concavity and a second nasal envelope.

Abstract: A conduit for delivering a supply of gas under a positive pressure includes a conduit wall having a first conduit end and a second conduit end. The first conduit end is adapted to be attached to the supply of gas. The conduit wall is deformable between (a) an open condition in which the conduit wall defines a conduit passage along which the supply of gas can travel between the first conduit end to the second conduit end, and (b) a collapsed condition in which the conduit wall substantially collapses the conduit passage.

Abstract: A patient interface system includes a nasal seal of flexible material to communicate with at least one airway of the patient, and a primary headgear from which the nasal seal is suspended, said primary headgear having at least one aperture though which at least a portion of the nasal seal is inserted with the primary headgear wrapping about at least one portion of the nasal seal in a sling-like fashion.

Abstract: Provided is an expansion-chamber muffler as a downsized sound muffler while keeping a function of noise reduction, comprising: a tube (A) which supplies and evacuates a gas having a noise, wherein the tube (A) in the midway has a cavity with a cross-sectional area larger than that of the tube (A); and at least two or more ports for inflow or outflow of the gas on the lateral side of a tube (B) extending from the expansion-chamber muffler, on the opposite side of the noise source generating the noise.

Abstract: The present invention relates to a system (100) for increasing a degree of relaxation of a person (10) using biofeedback. The system (100) comprises a first physiological parameter determining unit (20) for determining a first physiological parameter of the person (10), a reference parameter providing unit (60) for providing a reference parameter, a correlation determining unit (30) for determining a degree of correlation between the first physiological parameter and the reference parameter and a controller (40) for determining a control information based on the determined degree of correlation for controlling a light source unit (50), wherein in a mode of operation of the system the control information is adapted to control the light source unit (50) by dimming the light source unit and/or changing the color of the light from the light source unit to warmer color tones having a lower color temperature when the degree of correlation increases.

Abstract: Disclosed herein are an audio apparatus and method for inducing a brainwave using a binaural beat, including a frequency shift unit for receiving a first audio sound source signal and generating a second audio sound source signal by shifting some of the frequency band of the first audio sound source signal by a specific frequency, and an audio output unit connected to the frequency shift unit, for outputting first and second audio output signals corresponding to the first and the second audio sound source signals. Accordingly, a user can hear a music signal or an audio signal for learning without being aware of the distortion of a sound source and can change his or her brainwave state without resistance or monotonousness because a required brainwave state is changed by applying a binaural beat to a specific frequency band of an audio signal, in particular, a music signal.

Abstract: Exposure to stressors may be associated with the production of asymmetry in brain waves and can significantly affect a person's overall degree of wellbeing and conversely, asymmetry may influence a person's experience of stress. Through devices and methods that simultaneously look for asymmetries and in real time, one can create real time variable sequences of acoustical stimuli, and then one can effectively and efficiently support the brain to balance its activity between corresponding right and left lobes without one's mindful attention. Additionally various devices and methods can be used to identify condition states, including stress state conditions.

Abstract: Various embodiments are described herein to reduce sound sensitivities, improve state regulation, and/or reduce auditory processing and social engagement deficits in individuals with such deficiencies by recruiting the anti-masking functions of the middle ear muscles in order to optimize the transfer function of the middle ear for the processing of human speech. In certain embodiments, an individual may be subjected to a training protocol comprising one or more training sessions. During each training session, acoustic stimuli are provided to a subject for a period of time, with or without accompanying visual stimulation. A user response may be determined, for example, before beginning the protocol, during a session, after a session, and/or upon completion of the protocol. Such user response may be employed to adjust the acoustic stimulation, and the adjusted acoustic stimulation may be provided to the subject during a subsequent training session (or at a subsequent time within the same training session).

Abstract: Described herein are methods and devices for delivering a drug to the frontal sinus system. An inflatable implant is positioned within the frontal sinus system using an anchoring means secured within the frontal sinus cavity. A drug-containing fluid is released directly into the frontal sinus drainage system.

Abstract: An intravascular catheter is disclosed that includes an elongated shaft defined by a wall including at least one port extending through the wall into a lumen. At least one channel may be defined between layers of polymer making up the catheter shaft. The channel extends along at least a portion of the shaft and is in fluid communication with the port. Outer and inner diameters of the catheter may be substantially constant along the length of the catheter.

Abstract: A urinary catheter has a body and an outer layer surrounding at least a portion of the body. The structure of the body is varied and non-uniform so as to impart a varying flexibility along the length of the catheter. The frame may be injection molded, while the outer layer may be extruded. The frame may also, or alternatively, have selected regions or portions that include planar or spiral cuts or a coiled filament or corrugations or a multifilament braid or weave or mesh to impart a desired flexibility profile. The flexibility profile of a male urinary catheter may include alternating rigid and flexible regions, with proximal and distal rigid regions being configured to be positioned within the bladder and penis, with two flexible regions separated by a rigid region positioned between the penis and bladder when the catheter is deployed within a male urethra.

Abstract: A deflectable catheter including an outer member having a proximal portion and a distal portion, an elongated column member extending distally from the outer member and an inner member positioned coaxial with the outer member and attached to the column member. The inner member extends distally of the outer member and has a distal tip portion. A reinforcement member is positioned over the column member to restrict axial movement of the column member such that when one of the inner member or outer member is moved with respect to the other, axial compression of the column member is restricted by the reinforcement member causing the distal tip portion of the inner member to deflect laterally.

Abstract: A catheter configured for intraluminal delivery to a location in the body of a patient, the catheter comprising a steerable assembly comprising a first segment connected to a second segment; the first segment comprises first and second cylindrical elements connected to each other by a first revolute joint in a first single plane; the second segment comprises third and fourth cylindrical elements connected to each other by a second revolute joint in a second single plane, wherein the first single plane and the second single plane are offset by an angle from each other.

Abstract: An improved handle for a steerable catheter apparatus steerably manipulated by steering wires or rods, and including an elongated housing having one end thereof adapted for attachment to the proximal end of the steerable catheter; a steering actuator carried by the housing and including an elongated lever pivotally affixed to the housing and rotatable about an axis transverse to both the length of the housing and the length of the lever and further having an end thereof attached to the steering wires or rods of the catheter to cause deformation of at least a portion of the catheter; and a locking mechanism carried by the lever for selectively locking the steering actuator in place relative to the housing during at least a portion of the time of use of the catheter apparatus.

Abstract: A self-catheterization assistance apparatus is presented. The apparatus has a base, a penis retention element coupled to the base and a catheter retention member coupled to the base. A penis is inserted into and securedly attached to the penis retention element. A catheter housing is inserted into and securedly attached to the catheter retention member. An optional advancer advances the catheter through the catheter housing and into the penis.

Abstract: A guidewire for use in a medical procedure includes an elongate guide member dimensioned for insertion within a body vessel of a subject. The guide member defines a longitudinal axis and has trailing and leading end segments. The leading end segment has a reduced cross-sectional dimension relative to a cross-sectional dimension of the trailing end segment. The leading end segment includes a first core element comprising a first material and a second core element comprising a second material different from the first material and being forward of the first core element. The first material of the first core element has greater rigidity than the rigidity of the second material of the second core element, to thereby facilitate advancement of, and application of torque to, the leading end segment while minimizing deformation.

Abstract: An apparatus for applying a substance to internal mammalian tissue is provided. The apparatus includes a member having a flexible, absorbent, porous portion connected to a non-porous portion. The apparatus may be used to treat atrial fibrillation or other non-atrial fibrillation issues with internal mammalian tissue.

Abstract: Provided are a pancreas perfusion apparatus capable of administering a drug only to the pancreas and strictly suppressing a leakage of the drug outside the pancreas and a method for controlling the same. The apparatus includes: a first vein occlusion section occluding a vein through which a venous blood from the pancreas flows; a second vein occlusion section occluding a vein into which a venous blood from collateral pathways outside the pancreas flows; an artery occlusion section occluding sites where an artery that nourishes the pancreas is connected to arteries that nourish other tissues; a drug administration section recovering a liquid upstream of the first vein occlusion section and supplying the recovered liquid to the artery; a systemic circulation section recovering a liquid upstream of the second vein occlusion section and feeding the recovered liquid into a systemic circulation; and a control device controlling the systemic circulation pump.

Abstract: An endoscopic peripheral includes a first end including at least a camera and one or more lights. The endoscopic peripheral may also include a second end may include a plug to physical connect the endoscopic peripheral to a computing device or a wireless device. The endoscopic peripheral may also include a flexible cable for communicating content captured by the camera to the computing device or wireless device.

Abstract: Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Many embodiments provide a swallowable device for delivering the agents. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade to release the drug into the bloodstream to produce a therapeutic effect. The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the intestinal wall. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

Abstract: A molding compact for forming a transdermal absorption sheet on which a needle-shaped protruding part is arranged is a molding compact that is a laminate of: a first member having a needle-shaped recessed part formed on a front surface thereof, the needle-shaped recessed part being an inverse of the needle-shaped protruding part; a second member provided on a back surface of the first member, the second member being composed of a waterproof and moisture-permeable material; and a third member provided on a back surface of the second member, the third member being composed of a rigid body. Provided are a molding compact that makes it possible to prevent leakage of a drug-containing solution filled into the needle-shaped recessed part, and a manufacturing method for a transdermal absorption sheet using the molding compact.