This invention serves to repurpose existing ethylene oxide sterilization chambers utilizing a novel chemical means of sterilization. Ethylene oxide is a longstanding gaseous sterilant for medical devices but has increasing problems associated with its hazards. Ethylene oxide is a carcinogenic and explosive chemical, and its emissions can be very harmful and cause serious health risks. Due to this, the FDA and many medical device manufacturers are trying to reduce or eliminate the use of the gas. Chlorine dioxide gas is a nearly identical alternative mode of sterilization that is non-carcinogenic and non-explosive. If firms choose to eliminate the use of ethylene oxide but do not want to waste the capital expenditure on existing sterilizers, they can instead utilize the ethylene oxide-to-chlorine dioxide conversion system of the present invention and use an effective and environmentally friendly form of sterilization in a system they already possess.

A sterilization apparatus for sterilizing a respiratory mask is described. The sterilization apparatus comprises a sterilization chamber, an articulating mask support disposed inside the sterilization chamber, a bi-directional fan system disposed inside the sterilization chamber and configured to move air through an air passage to simulate human breathing, and a sterilization agent generator coupled to the sterilization chamber. The bi-directional fan system pumps air that includes the sterilization agent back and forth through the oxygen mask via the air passage, to mimic normal breathing of an individual using the mask.

Systems and methods for cleaning and maintaining artificial airways sized for insertion within pediatric or neonatal patients (e.g., external diameters of less than 5 mm) are disclosed. The system includes a multi-port ventilator manifold configured to couple to a ventilation source, thereby forming a ventilator circuit with the patient. The manifold includes an occluder configured to advantageously reduce an amount of dead space in the manifold so as to prevent less of positive end expiratory pressure of the ventilator circuit and reduce the likelihood of broncho-pulmonary dysplasia of the patient, or even premature death.

The present invention provides a breathing assistance apparatus that has a convenient and effective method of cleaning internal conduits inside the apparatus. The breathing assistance apparatus is preferably a gases supply and humidification device. The cleaning method is a method of disinfection that is automated so minimal training is required to disinfect in particular an internal elbow conduit within the device. It is therefore not necessary to dismantle the gases supply and humidification device, therefore, inadvertent damage to the internal parts of the device is avoided. The present invention also provides a method of disinfecting a heated breathing conduit and a patient interface.

The disclosed technology provides thermoplastic polyurethane compositions having antimicrobial properties while still maintaining good physical properties and good non-fouling properties, methods of making the same, and articles, including medical devices, made from such compositions. The disclosed technology includes a process of making an antimicrobial polymer composition, where the process includes mixing an antimicrobial additive into a base polymer and further includes mixing in a non-fouling additive, where the antimicrobial additive is chemically held in the composition and the antimicrobial and non-fouling additives do not negatively impact each other's effectiveness.

A filter cartridge for a sterilizing cabinet includes a first gasket comprising a rigid or flexible edge portion and forming a frame defining a hollow center portion, a first filter comprising a porous material for maintaining a sterilized condition in the sterilizing cabinet and passing gaseous materials through the porous material, wherein the first filter is affixed to the first gasket, and a second filter comprising a porous material for maintaining a sterilized condition in the sterilizing cabinet and passing gaseous materials through the porous material, wherein the second filter is either affixed to the first filter or the first gasket opposite the first filter, and wherein the filter cartridge provides sufficient structural integrity to form a sealing interface with a confronting surface of the sterilizing cabinet.

A method of sanitizing at least a portion of a medical device with a sanitization system comprising a base comprising a sanitizing chamber, a sanitizing gas generator, a primary fan or pump, a secondary fan or pump, and a controller. The sanitizing operation comprising generating a sanitizing gas pulse including causing the sanitizing gas generator supplying a sanitizing gas and causing at least one of the primary fan or pump and the secondary fan or pump to operate for a pulse period, and conducting a dwell operation after the pulse period, the dwell operation comprising discontinuing supply of said sanitizing gas and slowing or stopping said primary fan or pump and said secondary fan or pump for a dwell time.

A method of sterilizing an article such as a flexible endoscope is performed in a sterilization chamber. A vacuum is applied in the sterilization chamber while the article is contained in the sterilization chamber. A sterilant is then introduced into the sterilization chamber. The pressure within the sterilization chamber is incrementally increased to provide a step-wise transition from a high vacuum state to atmospheric pressure. The article is thereby sterilized.

A barrier layer and corresponding method of making provide anti-inflammatory, non-inflammatory, and anti-adhesion functionality for a medical device implantable in a patient. The barrier layer can be combined with a medical device structure to provide anti-adhesion characteristics, in addition to improved healing, non-inflammatory, and anti-inflammatory response. The barrier layer is generally formed of a naturally occurring oil, or an oil composition formed in part of a naturally occurring oil, that is at least partially cured forming a cross-linked gel. In addition, the oil composition can include a therapeutic agent component, such as a drug or other bioactive agent.

Embodiments of the invention relate to a method and apparatus for self-sterilizing a surface or other portion of the apparatus and/or sterilizing other objects. Embodiments can utilize self-generated and/or remotely controlled plasma fields for the purpose of self-sterilization and/or sterilization of another object. Embodiments of the invention can have broad applications in procedures and equipment requiring the sterility of devices used for medical procedures, decontamination procedures, drug delivery, sterility of consumer products, and sterility of food preparation equipment and tools.