Abstract: The present invention relates to a neural implant comprising a biomaterial having an outer surface with a stochastic nanoroughness (Rq), and the application of said stochastic nanoroughness in the diagnosis and/or treatment of a neurological disorder, such as, for example, Parkinson's disease, Alzheimer's disease, glioblastoma and/or for disrupting and/or preventing glial scars in the context of mammalian mechanosensing ion channels selected from the family of PIEZO-1 and PIEZO-2 ion channels.

Abstract: The present disclosure generally relates to a composite scaffold containing insulin-mimetic materials for healing bone defects (e.g., bone repair). In particular, the present disclosure relates to a fibrous composite containing a synthetic polymer, nanoceramic and a vanadium salt to improve the healing of bone defects.

Abstract: A scalable microfluidic based artificial skin covers a variety of wounds while also providing efficient healing of the wounds. The artificial skin comprises a plurality of microfluidic panels separated by semi-permeable membranes, and also comprising a plurality of micro-pumps and micro-channels for carrying healing fluids in proximity to the wound on the natural skin. The panels form detachable patches that are inert and biocompatible. The panels are fabricated from polydimethylsiloxane materials and impregnated with silver nanocrystalline powder. A first panel partially engages the natural skin, partially supported by micro-pillars. Large micro-channels carry contaminants from the wound. A second panel and an optional third panel having micro-channels that carry healing fluids to the wound. A first and second semi-permeable membrane regulate passage of fluids, cellular components, and debris between the panels. An inlet port enables passage of healing fluids to the wound.

Abstract: The present invention provides formulations comprising polymers and therapeutics and methods for their manufacture. The present invention also provides medical devices coated with such formulations and methods for their manufacture. The drug-loaded polymer formulations, solutions, and films tailor the drug release characteristics for medical devices.

Abstract: The present invention relates to a method for preparing a surgical anti-adhesion barrier film comprising the following steps: a°) a first solution, comprising an oxidized collagen is prepared, b) a polyphosphate compound is added to the solution of a) in a quantity so as to obtain a concentration of polyphosphate ranging from 0.007 to 0.7%, by weight, with respect to the total weight of the solution, c) the pH of the solution obtained in b) is adjusted to about 9 by addition of a base or to about 5.1 by addition of an acid, d) a diluted solution is prepared by adding water to solution of c), e) a first layer of solution obtained in c) is casted on an inert support, f) before complete gelation of the layer obtained in d), a second layer, of diluted solution obtained in d) is applied on top of said first layer and let to gelify, g) the gelified first and second layers are dried to obtain a film.

Abstract: A biocompatible membrane comprised of alginate and hyaluronate. The membrane may be used to prevent unwanted scarring after surgery. The tissue adherence and the rate of bioresorption of the membrane may be modified through an external stimulus comprising a sequestering agent and a viscosity modifier.

Abstract: The present invention provides an orthopaedic implant including a base device having a device surface and a fixation material attached to at least one portion of the device surface. The fixation material is configured to provide a minimally sufficient adhesive force to resist natural pull out caused by forces acting on the base device after implantation and bone growth. Also provided is a method of manufacturing an orthopaedic implant. A base device with a device surface is provided and a minimally sufficient adhesive force, that can resist natural pull out caused by forces acting on the base device after implantation and bone growth, is determined. A proper amount of fixation material sufficient to provide an adhesive force equal to the minimally sufficient adhesive force is determined and fixation material is applied to the device. When the proper amount of fixation material is applied to the device surface, application is stopped.

Abstract: Methods of treating with a biodegradable polymeric stent made from poly(L-lactide) and a low concentration of L-lactide monomer is disclosed. The concentration of L-lactide is adjusted to provide a degradation behavior that is suitable for different treatment applications including coronary, peripheral, and nasal.

Abstract: In some aspects, the present invention provides surgical procedures that comprise applying compositions into and/or onto tissue, including supporting tissues (e.g., ligaments, connective tissue, muscles, etc.) for pelvic organs, among other tissues. In other aspects, the present disclosure pertains to compositions that are useful for performing such procedures. In still other aspects, the present disclosure pertains to kits that are useful for performing such procedures.

Abstract: The present disclosure illustrates a sensor-controlled nasal aspirator including a distance sensing unit, a micro processing unit and an air pump. The distance sensing unit is configured to sense a distance between a target object and the distance sensing unit. The micro processing unit is configured to store a preset distance, and receive and process the distance transmitted from the distance sensing unit, and transmit an action command signal when the distance is not higher than the preset distance. The air pump is configured to receive the action command signal and performs a target action according to the action command signal.

Abstract: An apparatus for cleansing wounds, in which wound exudate is removed from a wound bed and selectively cleansed and returned to the wound. The cleansing means removes materials deleterious to wound healing, and the cleansed fluid, still containing materials that are beneficial in promoting wound healing, is returned to the wound bed. The associated wound dressing and cleansing means are conformable to the wound, and may have irrigant fluid circulated from a reservoir by a device for moving fluid through a flow path which passes through the dressing and a means for fluid cleansing and back to the dressing.

Abstract: A combination kidney and liver dialysis system and method provides a portable, lightweight hemodialysis device that removes uremic toxins, hepatic toxins, water, and impurities from the blood. The method comprises separating the blood into a plasma portion and a cellular portion, immediately returning the cellular portion to the body, providing large volumes of replacement fluids, diluting the plasma portion with replacement fluids, and then manipulating the plasma portion of the blood to pass through hemoperfusion membranes, hemodiafiltration membranes, and extracorporeal membrane oxygenation membranes. Dialysis is performed on the plasma portion of the blood with an albumin dialyzer against an albumin dialysate and a high molecular weight cut off membrane. Dialysis is performed on the plasma portion of blood with a lipid dialysate comprising 10-30% lipid composition, and a high flux dialyzer.

Abstract: A disposable cartridge for use in a hemodialysis machine has a blood flow path for carrying a volume of blood to be treated in a dialyser and a dialysate flow path, isolated from the blood flow path, for delivering a flow of dialysate solution through the dialyser. The cartridge is received in an engine section of the machine. The engine section has first and second platens which close when the cartridge is inserted to retain the cartridge. Actuators and sensors arranged on the second platen control operation of the cartridge.

Abstract: An extracorporeal blood treatment device for operation with a single patient connection, connected by an arterial and a venous blood line to an extracorporeal blood circuit, and a method for operating a blood treatment device with a single patient connection. The blood treatment device has two apparatuses for conveying blood in the arterial and venous blood lines. The second apparatus for conveying blood comprises means for collecting blood and means for establishing a pressure in the means for collecting blood, so that blood collected in the means for collecting blood flows to the patient connection. Furthermore, the blood treatment device has arterial and venous closure elements for interrupting the flow of liquid in the arterial and venous blood lines, as well as a control unit for actuating the two apparatuses for conveying blood and the arterial and venous closure elements.

Abstract: The present invention relates to the field of bio-artificial liver technology. Particularly, the invention provides an integrated hybrid bio-artificial liver support system that provides the features of artificial liver assist devices with that of bio-artificial liver support systems.

Abstract: An extracorporeal blood treatment apparatus (1) comprising a control unit (10) connectable to a blood warming device (200). The apparatus (1) comprises: an extracorporeal blood circuit (100) and at least one infusion line (15, 21, 25) connected to the extracorporeal blood circuit (100). A control unit (10) is configured to execute the following procedure: receiving a first value representative of a desired blood temperature (Tdes) at an end (70) of a blood return line (7) configured to be connected to a venous vascular access of a patient (P); receiving at least a first signal relating to at least a flow rate (QPBP, QREP1, QREP2) of an infusion fluid in the at least one infusion line (15, 21, 25); calculating a set point value of an operating parameter (TOUT; Pw) to be imposed on the warming device (200) configured to heat a blood heating zone (H) of the extracorporeal blood circuit (100) in order to maintain the desired blood temperature (Tdes) at the end (70) of the blood return line (7).

Abstract: Methods and devices are disclosed for the treatment of a subject suffering from drug intoxication by cleansing a contaminated sample from the subject with adsorption media. The adsorption media composition is selected for its antithrombogenic properties and for its ability to adhere to one or more drug targets to be reduced or eliminated. The media can further be held in a cartridge for use in extracorporeal treatments such as those of hemoperfusion. Contacting the contaminated sample from the subject with the absorption medium allows for the separation of a portion of the drug target from the sample, producing a cleansed sample that can be infused into the subject.

Abstract: An air trap for a blood circuit and method for removing air from blood in a dialysis unit. The air trap may include a blood inlet supply line, a blood outlet supply line, and a container having an approximately spherical internal wall, an inlet at a top end of the container connected to the blood inlet supply line, and an outlet at a bottom end of the container connected to the blood outlet supply line. The inlet may be offset from a vertical axis of the approximately spherical internal wall such that blood entering the container is directed to flow in a spiral-like path. The inlet port may be arranged to introduce blood into the container in a direction that is approximately tangential to the approximately spherical inner wall of the container and/or in a direction that is approximately perpendicular to the vertical axis of the container.

Abstract: A split-tip catheter and methods for deploying a split-tip catheter in a right atrium are provided. The catheter is configured with a distal potion including a first and a second distal end regions elastically divergable from alignment along a splitting plane to regain a relaxed configuration. The first distal end region terminates in a first tip having a first forward opening, and the second distal end region terminates in a second tip having a second forward opening. Catheter deployment may include directing the first forward opening generally towards an anterior right atrium wall portion and applying the first forward opening to withdraw blood from the right atrium.

Abstract: An oxygen supply unit for use with a blood oxygenator comprises an oxygen concentrator and a carbon dioxide scrubber. In an on-line operational mode, oxygen-rich gas from the oxygen concentrator is predominantly supplied to the blood oxygenator with a reduced flow of recycled gas from the concentrator. In an off-line operational mode where the oxygen supply unit is being powered by battery only, a larger flow of recycled gas from the blood oxygenator is passed through the carbon dioxide scrubber and combined with a lesser amount of oxygen-rich gas from the oxygen concentrator. The oxygen supply unit may be used in combination with a blood pump and oxygenator to provide ambulatory blood oxygenation to patients with compromised lung function.

Abstract: An anal irrigation system including a control unit (2) is provided. The control unit (2) is connected to an external tube (4) by an extension cord (9), so that pivoting of the control unit (2) with respect to the external tube (4) is possible.

Abstract: A packaging for a medical device and medicament comprising a packaging body having first and second regions. A medicament delivery device is received in the first region and a medicament container is received in the second region. The medicament delivery device includes a chamber configured to receive the medicament container. The packaging body includes a hinge between the first and second regions such that the first and second regions are pivotable about the hinge from a storage position in which the first and second regions are spaced apart to a loading position in which the first region lies adjacent the second region. The chamber and medicament container are equidistantly spaced from the hinge such that the medicament container is loaded into the chamber when the first and second regions are pivoted into the loading position.

Abstract: A device configured to deliver a medicament to a user by injection, comprising an injection feedback apparatus configured to apply temperature-based feedback to the user regarding the delivery of the medicament.

Abstract: A medicament delivery device comprises a housing containing a medicament delivery mechanism including an injection needle. The housing includes a contact surface having a first adhesive layer. The device further includes a sterilizing pad adhered to the housing. A second adhesive layer is formed proximate the sterilizing pad. A cover is detachably adhered over the sterilizing pad by the second adhesive layer and covers the sterilizing pad.

Abstract: A drug delivery device (100), including a body (104, 116) having a reservoir (164, 176) disposed therein for containing a medicament and an injection needle (152) for penetrating the skin of a patient, the needle (152) providing a path for the medicament between the reservoir (164, 176) and the patient. The device (100) also includes a needle cover (114) for selectively covering the injection needle (152), an adhesive (264) for selectively adhering the device to the patient, a release liner (500) for selectively covering a patient side of the adhesive (264), and a connecting means (112, 520, 512, 508, 524) for connecting the needle cover (114) and the release liner (500) such that removal of one of the needle cover (114) and the release liner (500) from the device (100) removes the other one of the needle cover (114) and the release liner (500).

Abstract: A valve for a tubing kit used provides a resilient element naturally moving to a closed state to reduce opportunity for inadvertent leakage of medicine and to reduce effort required by healthcare personnel to seal the fluid line. In one embodiment the resilient element is a spring serving to compress the walls of IV tube in the closure and in a second embodiment the resilient element is an elastomeric member that is deformed to provide an opening to allow passage of fluid through the fluid line.

Abstract: Processes for operating an infusion pump are provided for pumping fluid though an administration set at a constant flow rate. The pump includes a pumping mechanism for pumping fluid and operates at a pulse frequency, and a controller controls the pulse frequency. Additionally, the pump has one or more sensors configured for measuring at least one characteristic value relating to a status of the infusion pump. The controller is configured for causing the pumping mechanism to operate at a first pulse frequency, and the one or more sensors measure the characteristic value. When the measured characteristic value meets a threshold value, the controller causes the pumping mechanism to operate at a second pulse frequency different from the first pulse frequency.

Abstract: Methods and systems are disclosed for estimating a glucose level of a person having diabetes and selecting automatically open-loop and closed-loop control for a connected therapy delivery device. The method may comprise analyzing measured glucose results and corresponding impedance values received from a glucose sensor coupled to the person with a probability analysis tool implemented by a microcontroller to determine a total quality score that is based on the minimum constraint of a probability of glucose sensor accuracy determined measured glucose results and a probability of sensing quality determined from the impedance values. The microcontroller may estimate the glucose level of the person with a recursive filter based on the plurality of measured glucose results weighted with the total quality score and select automatically either open-loop control or closed-loop control for the connected therapy delivery device based on the value of the total quality score.

Abstract: Methods and devices involving using a bolus calculator for calculating a correction insulin dose accounting for continuous glucose monitoring noise. More specifically, methods and devices using an algorithm executed by a processor of the bolus calculator and using a glucose measurement and uncertainty of the glucose measurement to determine if a standard correction dose should be adjusted once calculations are performed for the standard correction dose and hypoglycemia-averse correction insulin dose and the two doses are compared.

Abstract: Methods and apparatus for the reproducible, consistent and efficacious delivery of a therapeutic agent to a patient. The invention comprises means for the controlled administration of the therapeutic agent through an orifice to the patient, a plurality of penetrating electrodes arranged with a predetermined spatial relationship relative to the orifice, and means for generating an electrical signal operatively connected to the electrodes.

Abstract: A syringe assembly includes a syringe barrel having a first end, a second end, and a sidewall extending between the first end and the second end. The syringe assembly further includes a stopper disposed within a chamber of the syringe barrel, a plunger adapter engaged with the stopper, and a plunger rod having first and second ends. The first end of the plunger rod is pivotally secured to the plunger adapter. The plunger rod has a pre-use position where the second end of the plunger rod is positioned adjacent to the syringe barrel, and a use position where the plunger rod is configured to displace the stopper relative to the syringe barrel. A recessed portion of the plunger adapter receives a portion of the first end of the plunger rod when the plunger rod is in the pre-use position and the use position.

Abstract: The present invention provides a sterile solution comprising leuprolide acetate in a pharmaceutically acceptable vehicle, wherein solution is present as a reservoir in a multiple dose pen injection device, the device being adapted to subcutaneously inject a portion of the said reservoir in a single daily dose and further being adapted to provide multiple portions of solution said while the reservoir remains sterile.

Abstract: Medicament delivery device comprising a movable guard (10) being movable between a proximal and a distal position and a locking mechanism (15) having a lever (16), the lever (16) restricting movement of an actuation locking member (24) until the movable guard is positioned in a distal position and the lever (16) restricting movement of the guard (10) in a proximal position after actuation of the device.

Abstract: A self-injection device (100, 200), including a pen body (108, 208) connectable to a pen needle (10), and a cap (104, 204) selectively connectable to the pen body (108, 208) in a first orientation with respect to the pen body (108, 208) to minimize the length or volume of the self injection device (100, 200), and in a second orientation to provide sufficient length or volume in an interior of the cap (104, 204) to house a pen needle (10) connected to the pen body (108, 208).

Abstract: The present disclosure relates, according to some embodiments, to a puncture needle that can prevent the occurrence of coring. A puncture needle according to the present disclosure includes a cannula provided with a lumen. The cannula has a blade surface. The blade surface has: a sharp region located on a tip side of the blade surface and provided with a sharp edge on inner and outer circumferences of the blade surface; and a blunt region located on a base end side of the blade surface and provided with a blunt edge on the inner and outer circumferences of the blade surface. A tip of the blade surface is provided with a thick portion formed by a boundary between two surfaces, and the boundary forms an edge.

Abstract: A system for positioning a distal end of a surgical device within a patient to conduct a surgical procedure or administer a fluid to the patient, or both, is disclosed. The system may use ultrasound to accurately position a surgical device within a patient while being as minimally invasive as possible. As such, the system may include first inserting a needle into a patient under guidance of ultrasound, inserting a guide wire into the needle, removing the needle and inserting a surgical device into the patient along the at least one guide wire. As such, the minimally intrusive needle is first inserted into the patient in a correct position before a larger medical device is inserted to prevent unnecessary intrusion into the patient. In at least one embodiment, the surgical device may be positioned within a patient using a drive handle removably attached to a portion of the surgical device.

Abstract: An infusion pump system is disclosed. The system includes at least one infusion pump, a companion device, the companion device in wireless communication with the infusion pump, and a user interface on the companion device, the user interface adapted to receive textual input.

Abstract: Methods, systems, and devices are described for sealing a nebulizer's liquid reservoir. A nebulizer liquid reservoir may be provided that is in fluid communication with an aerosol generator. The nebulizer liquid reservoir may have an open end and a headspace. A cap may be placed on the open end of the nebulizer liquid reservoir, wherein the cap partially fills the headspace of the nebulizer liquid reservoir. The cap can include a plunger that passes through the cap and allows for air to escape from the headspace of the nebulizer liquid reservoir through the cap. The cap can seal the nebulizer liquid reservoir by actuating the plunger to a locked position. The plunger may create an airtight seal with the cap when in the locked position. An ambient pressure may be maintained in the sealed nebulizer liquid reservoir until a portion of the liquid is dispensed.

Abstract: A valve (1, 11, 19) for an inhalation device comprising an interior volume that is delimited at least partially by a valve wall (4, 17, 21), a permanent opening (29) as well as a valve functional area (6), whereby the valve functional area (6) is configured to be at least almost closed below an opening pressure difference and to be open above an opening pressure difference such that above the opening pressure difference, a fluid can flow through the permanent opening (29) into the interior volume and out of the valve functional area (6), the valve comprising an inversion protector that is configured to impede or prevent inversion of the valve wall (4, 17, 21).

Abstract: The invention relates to a respiratory assistance apparatus (1) usable by a first responder, such as a doctor from the emergency ambulance service, a fire fighter, a nurse or the like, when this first responder is performing cardiac massage on an individual (20) in cardiopulmonary arrest, in order to ventilate the said individual while he or she is being subjected to chest compressions. According to the invention, the respiratory assistance apparatus (1) comprises signal processing means designed to supply the display means with a corrected frequency value (Fc) corresponding to the frequency value (F) determined immediately before the start of a time of duration (Dh, Db) considered, when the signal processing means do not detect a chest compression (CC) for part of the said duration (Dh, Db) considered.

Abstract: A surgical instrument system for use in a surgical procedure is disclosed. The surgical instrument system may include an instrument configured to puncture the tissue of a patient and detect when the instrument has entered a lumen of the patient's body. Liquid may be present in the lumen or the lumen may be devoid of liquid or tissue. The instrument is configured to determine when the needle tip is engaged with a portion of patient's tissue and determine when the needle tip has exited that portion of the patient's tissue by detecting changes in properties of the tissue, specifically, electrical resistance.

Abstract: The present invention relates to a device for delivering a supply of gases to a patient. The device includes a patient interface and connecting member. The connecting member is preferably a L-shaped swiveled connector that is capable of being fixed into one of two positions, a first position where the connector is freely rotatable within the patient interface, and a second position where an interference between the interface and connector prevents the free rotation of the connector within the patient interface, The present invention further relates to a connector that has outlet means, which includes at least one outlet vent and a funnel, which in use directs and passes a substantial portion gases expired from the patient through the outlet vent or vents.

Abstract: A respiratory mask assembly for delivering breathable gas to a patient includes a frame having a front surface and a rear surface adapted in use to face the patient. The frame includes a main body providing an aperture therethrough for the introduction of breathable gas into a nasal breathing cavity. An elbow assembly is swivelably coupled to the front surface of the frame. The elbow assembly includes a swivel elbow that defines an intake port and an exhaust port separated from the intake port using a baffle. The elbow assembly includes an end portion that interfaces with the aperture of the frame.

Abstract: A mask system and an air delivery conduit for use in the treatment of respiratory disorders. The air delivery conduit may comprise a textile having an airtight arrangement. A support structure may be provided to the conduit to provide form.

Abstract: The invention relates to an on-site medical gas production plant (100) comprising a unit (50) for purifying gas, such as air, a first compartment (A) for storing purified gas, and a main gas line (10) fluidically connecting the gas purification unit (50) to the said first storage compartment (A). It furthermore comprises a three-way actuated valve (VA) arranged on the main gas line (10) upstream of the first storage compartment (A), and furthermore connected to the atmosphere (at 12) via a vent line (11), as well as an operating device (4) which controls at least the three-way actuated valve (VA), and at least a first gas analysis device (D1) of which a first measurement line (29) is fluidically connected (at 28) to the main line (10), upstream of the three-way actuated valve (VA), and which is electrically connected to the said operating device (4).

Abstract: A humidification system for delivering humidified gases to a user can include a heater base, humidification chamber having an inlet, outlet, and associated fluid conduit, and breathing circuit including a supply conduit, inspiratory conduit, and optional expiratory conduit. The humidification system can include various features to help make set-up less difficult and time-consuming. For example, the supply conduit, inspiratory conduit, and optional expiratory conduit can be coupled into a one-piece circuit to aid set-up. Various components can be color-coded and can have corresponding structures to indicate which components should be connected to one another during set-up. Such features can also help make the set-up process more intuitive for an operator, which can reduce the need for specialized training and reduce the number of potential errors.

Abstract: Adverse effects of pain in a premature infant, especially a very or extremely premature infant may be ameliorated by exposing the infant to stimuli comprising one or more of vertical oscillating motion simulating breathing, skin contact with an interface that mimics human skin and exposure to sounds and/or vibrations that simulate heartbeats. A device including a movable platform provides such stimuli within a neonatal intensive care incubator. The device provides simulated maternal breathing through vertical movement at a rate and speed similar to that experienced by an infant lying upon its mother's chest. It further provides simulated maternal skin interface feel as well as heartbeat sound. These simulated sensory parameters appear to have an innate calming effect upon a preterm infant that reduces the duration and severity of the infant's response to a pain event. The same stimulations may reduce occurrence of below-baseline fluctuations of brain blood oxygen content.

Abstract: An eye mask for use to wake up and/or to go to sleep provides ease of cleaning or replacement without damaging electrical or optical components; different user selectable sunrise and sunset illumination modes respectively having blue-shifted and red-shifted spectra simulating natural sunrises and sunsets to assimilate the sleep/wake cycle to the natural rhythms of day and night; sunset and/or sunrise illumination modes that oscillate with fixed period or sequentially changing periods that correspond to brainwave frequencies that respectively facilitate going to sleep and/or waking and synergistically co-operate with corresponding sunset or sunrise light fields to help the user to fall into restful sleep or to awake refreshed and alert; and audio tone programming of illumination mode and treatment time and/or duration of therapy by a remote tone control generator.

Abstract: Preclinical and clinical studies have shown that the autonomic nervous system (parasympathetic and sympathetic nervous systems) show reliable changes across the sleep wake cycle. Most importantly, the parasympathetic nervous system shows increased activity during sleep consistent with its role in regulating rest. Further, patients with insomnia show reduced parasympathetic activity and/or increased sympathetic activity during sleep consistent with a neurobiological model of “hyperarousal”. Described herein are methods and apparatuses that activate the parasympathetic nervous system in response to a diving reflex; a sustained diving reflex may, surprisingly, lead to enhancing sleep. The apparatuses and methods described herein may specifically and/or selectively activate this reflex may play a therapeutic role in the modulation of sleep in insomnia patients.

Abstract: A catheter assembly includes a catheter body extending from a catheter proximal portion to a catheter distal portion. The catheter body includes an inner liner and an outer sleeve. A braid assembly is within the catheter body and between the inner liner and the outer sleeve. The braid assembly includes a first filar array including one or more first filars helically extending around the catheter body in a first direction. The braid assembly further includes a second filar array including one or more second filars helically extending around the catheter body in a second direction opposed to the first direction.