Abstract: Seal integrity indicators for sterilization containers are provided. For example, a seal indicator may indicate whether the container is sufficiently sealed to prevent an ingress of contaminants into the container. If the container is sufficiently sealed, the seal indicator is visible, but if not, the seal indicator is not visible. Thus, the seal indicator undergoes a change in state when the sterilization container transitions from unsealed to sealed, or vice versa, such that a user may ascertain whether the container is properly sealed to maintain the container's sterility. An exemplary seal indicator includes an invertible projection formed with the container gasket that is not visible from outside the container until inverted, due to force applied by the lid, to extend through an opening in the container body. Closure mechanisms for sterilization containers also are provided.

Abstract: A scatter radiation protection device is provided. The scatter radiation protection device includes a barrier that is movable in an x-direction, a y-direction, and a z direction; a skirt that is movable in an x-direction; and a sliding track having an upper surface and a lower surface. The barrier and the skirt are configured for connection to the sliding track, and the barrier and the skirt provide for at least 0.5 millimeters of lead (mmPb) equivalence.

Abstract: A protective guard is provided for sealing an interface. The protective guard includes a body having a fluid impervious material and proximal and distal segments that may comprise a superabsorbent or a non-superabsorbent material. The proximal and distal segments are positioned on first and second sides, respectively, of the interface. The protective guard extends about the interface to create a fluid barrier. In some embodiments, the non-superabsorbent material may be an elastic material, such as an elastic band, and in particular embodiments, the non-superabsorbent material may be nitrile. In further embodiments, the non-superabsorbent material may be an expandable material that expands upon contact or interaction with a fluid.

Abstract: A folded article formed from a protective garment, and a method of folding a protective garment to prepare the garment for donning, expose sleeve openings of the garment for ease of donning. The protective garment is folded into a folded article that is configured to be grasped by an inner surface of the garment and prevent touching the outer surface of the garment during donning. Thus, the sterility of the protective garment can be maintained during donning. The protective garment may further include a hood and visor, and the folded article formed from the protective garment may have the same size and shape as the visor.

Abstract: A multi-layer visor system for a surgical hood or garment is provided. The system includes a base film layer and one or more removable film layers that are coextruded at high temperature to form a sterile surface between each of the film layers should the surgeon elect to peel away a soiled or splattered removable film layer during the course of a surgical procedure so that an unobstructed view can be maintained. Thus, no separate sterilization step is required in order to sterilize the layers of the visor system. Each of the removable film layers can additionally include a tab having distinctive features in order to enable a wearer to easily distinguish between the tabs in order to make it easier for a wearer to know which tab to pull first to remove the outermost removable film layer.

Abstract: A multi-layer visor system for a surgical hood or garment is provided. The system includes a base film layer and one or more removable film layers that are coextruded at high temperature to form a sterile surface between each of the film layers should the surgeon elect to peel away a soiled or splattered removable film layer during the course of a surgical procedure so that an unobstructed view can be maintained. Thus, no separate sterilization step is required in order to sterilize the layers of the visor system. Each of the removable film layers can additionally include a tab having distinctive features in order to enable a wearer to easily distinguish between the tabs in order to make it easier for a wearer to know which tab to pull first to remove the outermost removable film layer.

Abstract: Seal integrity indicators for sterilization containers are provided. For example, a seal indicator may indicate whether the container is sufficiently sealed to prevent an ingress of contaminants into the container. If the container is sufficiently sealed, the seal indicator is visible, but if not, the seal indicator is not visible. Thus, the seal indicator undergoes a change in state when the sterilization container transitions from unsealed to sealed, or vice versa, such that a user may ascertain whether the container is properly sealed to maintain the container's sterility. An exemplary seal indicator includes an invertible projection formed with the container gasket that is not visible from outside the container until inverted, due to force applied by the lid, to extend through an opening in the container body. Closure mechanisms for sterilization containers also are provided.

Abstract: A personal protection and ventilation system is provided. The system includes a gown having front and rear panels, a hood, and visor; a fan; an air tube; and a helmet. The fan is positioned between the wearer and a body-facing surface of the rear panel. The front panel and at least a portion of the hood are formed from a first material including a first spunbond layer, a spunbond-meltblown-spunbond laminate, and a liquid impervious elastic film disposed therebetween. The first material has an air volumetric flow rate of less than about 1 standard cubic feet per minute (scfm). The rear panel is formed from a second material including a nonwoven laminate having an air volumetric flow rate of about 20 scfm to about 80 scfm. Therefore, the fan is able to intake a sufficient amount of air from the environment through the rear panel to provide cooling/ventilation to the hood.

Abstract: A personal protection and ventilation system is provided. The system includes a gown having front and rear panels, a hood, and visor; a fan; an air tube; and a helmet. The fan is positioned between the wearer and a body-facing surface of the rear panel. The front panel and at least a portion of the hood are formed from a first material including a first spunbond layer, a spunbond-meltblown-spunbond laminate, and a liquid impervious elastic film disposed therebetween. The first material has an air volumetric flow rate of less than about 1 standard cubic feet per minute (scfm). The rear panel is formed from a second material including a nonwoven laminate having an air volumetric flow rate of about 20 scfm to about 80 scfm. Therefore, the fan is able to intake a sufficient amount of air from the environment through the rear panel to provide cooling/ventilation to the hood.

Abstract: Seal integrity indicators for sterilization containers are provided. For example, a seal indicator may indicate whether the container is sufficiently sealed to prevent an ingress of contaminants into the container. If the container is sufficiently sealed, the seal indicator is visible, but if not, the seal indicator is not visible. Thus, the seal indicator undergoes a change in state when the sterilization container transitions from unsealed to sealed, or vice versa, such that a user may ascertain whether the container is properly sealed to maintain the container's sterility. An exemplary seal indicator includes an invertible projection formed with the container gasket that is not visible from outside the container until inverted, due to force applied by the lid, to extend through an opening in the container body. Closure mechanisms for sterilization containers also are provided.

Abstract: Closure mechanisms and seal integrity indicators for sterilization containers are provided. For example, a closure mechanism comprising at least one handle and at least two arms is provided with a sterilization container lid to apply a more uniform or evenly distributed force to a container gasket. A container body defines an inner lip on which the gasket and lid are received such that the sealing interface is recessed within the container. Further, a seal indicator may indicate whether the container is sufficiently sealed to prevent an ingress of contaminants into the container. If the container is sufficiently sealed, the seal indicator is visible, but if not, the seal indicator is not visible. Thus, the seal indicator undergoes a change in state when the sterilization container transitions from unsealed to sealed, or vice versa, such that a user may ascertain whether the container is properly sealed to maintain the container's sterility.

Abstract: A folded article formed from a protective garment, and a method of folding a protective garment to prepare the garment for donning, expose sleeve openings of the garment for ease of donning. The protective garment is folded into a folded article that is configured to be grasped by an inner surface of the garment and prevent touching the outer surface of the garment during donning. Thus, the sterility of the protective garment can be maintained during donning. The protective garment may further include a hood and visor, and the folded article formed from the protective garment may have the same size and shape as the visor.

Abstract: A multi-layer visor system for a surgical hood or garment is provided. The system includes a base film layer and one or more removable film layers that are coextruded at high temperature to form a sterile surface between each of the film layers should the surgeon elect to peel away a soiled or splattered removable film layer during the course of a surgical procedure so that an unobstructed view can be maintained. Thus, no separate sterilization step is required in order to sterilize the layers of the visor system. Each of the removable film layers can additionally include a tab having distinctive features in order to enable a wearer to easily distinguish between the tabs in order to make it easier for a wearer to know which tab to pull first to remove the outermost removable film layer.

Abstract: Sterilization packaging systems with features for sealing a volume against an ingress of contaminants are provided. Such features include a sealing assembly including a gasket and a sheet of filter material. The sealing assembly seals a lid to a seal rim of a base. The gasket has an upper surface, outer edge, and inner edge. The sheet of filter material extends from an inner edge of the gasket, and the gasket completely surrounds the sheet of filter material. The upper surface of the gasket comprises a plurality of indentations that define channels to facilitate delivery of a sterilization agent through the filter material. A sterilization assembly including a lid having a plurality of protrusions in its upper surface and a sliding-lock system for sealing and locking the lid to a container base is also provided.

Abstract: A pocket and drape system which provides one or more sterile fields, as well as the methodology for employing said pocket and drape system is provided. The pocket and drape system includes a base drape material having an upper edge, a lower edge, a first side edge, and a second side edge to define a perimeter. The base drape material further includes a first longitudinal fold line, a second longitudinal fold line, a first transverse fold line and a second transverse fold line, wherein the first and second transverse fold lines are generally perpendicular to the first and second longitudinal fold lines. The base drape material has a first surface and an opposing second surface. The system further includes a first row of pockets configured on the first surface of the flap, and a second row of pockets configured on the first surface of the base drape material. In addition, the system includes a flap configured to maintain at least one sterile field.

Abstract: Apparatus, systems, and methods for sealing an interface are provided. For example, a protective guard is provided for sealing an interface. The protective guard comprises a body comprising a fluid impervious material and proximal and distal segments that may comprise a superabsorbent or a non-superabsorbent material. The proximal and distal segments are positioned on first and second sides, respectively, of the interface. The protective guard extends about the interface to create a fluid barrier. In some embodiments, the non-superabsorbent material may be an elastic material, such as an elastic band, and in particular embodiments, the non-superabsorbent material may be nitrile. In further embodiments, the non-superabsorbent material may be an expandable material that expands upon contact or interaction with a fluid.

Abstract: Closure mechanisms and seal integrity indicators for sterilization containers are provided. For example, a closure mechanism comprising at least one handle and at least two arms is provided with a sterilization container lid to apply a more uniform or evenly distributed force to a container gasket. A container body defines an inner lip on which the gasket and lid are received such that the sealing interface is recessed within the container. Further, a seal indicator may indicate whether the container is sufficiently sealed to prevent an ingress of contaminants into the container. If the container is sufficiently sealed, the seal indicator is visible, but if not, the seal indicator is not visible. Thus, the seal indicator undergoes a change in state when the sterilization container transitions from unsealed to sealed, or vice versa, such that a user may ascertain whether the container is properly sealed to maintain the container's sterility.

Abstract: An accessory cuff is configured to reinforce a gown-glove interface to protect a wearer from exposure to potential pathogens or contaminants through vulnerabilities in the gown-glove interface. The accessory cuff includes a body extending from a proximal end to a distal end along a longitudinal axis. The body has a lumen extending therethrough from the proximal end to the distal end, and a wall surrounding the lumen. The accessory cuff is configured to create a fluid impervious barrier to prevent fluid from entering the lumen when the accessory cuff is sealed at the proximal end and the distal end.

Abstract: Sterilization packaging systems with features for sealing a volume against an ingress of contaminants are provided. Such features include a sealing assembly including a gasket and a sheet of filter material. The sealing assembly seals a lid to a seal rim of a base. The gasket has an upper surface, outer edge, and inner edge. The sheet of filter material extends from an inner edge of the gasket, and the gasket completely surrounds the sheet of filter material. The upper surface of the gasket comprises a plurality of indentations that define channels to facilitate delivery of a sterilization agent through the filter material. A sterilization assembly including a lid having a plurality of protrusions in its upper surface and a sliding-lock system for sealing and locking the lid to a container base is also provided.

Abstract: A sterilization packaging system with features for sealing a volume against an ingress of contaminants is provided. Such features include a sealing gasket and a sheet of filter material. The gasket seals a lid to a seal rim of a container base of the sterilization packaging system. The gasket can enable quick identification of punctures, holes, tears, etc. so that the user notices immediately that the seal has been breached and that the contents of the sterilization packaging have been exposed to the outside environment.