Abstract: A sterile environment system can include an enclosure and a support system. The enclosure can include a barrier separating a sterile environment inside of the enclosure from a non-sterile environment outside of the enclosure. The barrier can include an expandable portion configured to expand from an unexpanded state to an expanded state for working within the sterile environment, and a patient-interfacing portion including a fenestration configured for placement directly over an area of interest of a patient, the fenestration having a sealed state and an unsealed state for access to the area of interest from within the sterile environment. The support system can be coupled to the patient-interfacing portion of the barrier such that it is positioned on at least opposite sides of the fenestration.

Abstract: Disclosed are enclosures for establishing a sterile environment over a patient for a medical procedure, as well as systems and methods thereof. An enclosure can include an expandable portion of a barrier separating a sterile environment inside of the enclosure from a non-sterile environment outside of the enclosure and a patient-interfacing portion of the barrier. The enclosure can also include a support system coupled to the patient-interfacing portion of the barrier in some embodiments. The patient-interfacing portion of the barrier can include one or more fenestrations for placement directly over one or more areas of interest of the patient, as well as for access to the areas of interest from within the sterile environment. When present, the support system can flank the fenestration. The support system is configured to support the enclosure on a surface when placed over an appendage of the patient or a main body of the patient.

Abstract: Disclosed are enclosures for establishing a sterile environment over a patient for a medical procedure, as well as systems and methods thereof. An enclosure can include an expandable portion of a barrier separating a sterile environment inside of the enclosure from a non-sterile environment outside of the enclosure and a patient-interfacing portion of the barrier. The enclosure can also include a support system coupled to the patient-interfacing portion of the barrier in some embodiments. The patient-interfacing portion of the barrier can include one or more fenestrations for placement directly over one or more areas of interest of the patient, as well as for access to the areas of interest from within the sterile environment. When present, the support system can flank the fenestration. The support system is configured to support the enclosure on a surface when placed over an appendage of the patient or a main body of the patient.

Abstract: An insertion assembly and method of manufacturing an insertion assembly. The method includes forming a catheter assembly including a catheter hub and a catheter, inserting a needle into the catheter assembly such that a distal tip of the needle extends distal of a distal end of the catheter, and permanently adhering an interface pad to the catheter hub. The interface pad can include a foam material including a haemostatic agent. The haemostatic agent can include microdispersed oxidized cellulose. The foam material can further include an antimicrobial agent such as chlorhexidine gluconate.

Abstract: A valved sheath introducer for venous cannulation, including a valve, sheath, handle and cap. The valve is configured to permit safe introduction and removal of medical instruments through the sheath introducer. The valve may have one or more anchoring members and a thickened central portion through which a slit is formed. The central portion may have one or more concave surfaces and the slit can be angled with respect to the top surface of the valve. The cap is attached to the handle, compressing a portion of the valve therebetween.

Abstract: A valved sheath introducer for venous cannulation, including a valve, sheath, handle and cap. The valve is configured to permit safe introduction and removal of medical instruments through the sheath introducer. The valve may have one or more anchoring members and a thickened central portion through which a slit is formed. The central portion may have one or more concave surfaces and the slit can be angled with respect to the top surface of the valve. The cap is attached to the handle, compressing a portion of the valve therebetween.

Abstract: Tear-away sheath introducers for catheters, methods for making such introducers, and methods for using such introducers are described. A splittable sheath introducer may include a sheath, a hub disposed at a proximal end of the sheath, a valve included with the hub, and a valve actuator movable from a first position to a second position, the valve actuator opening the valve when in the second position. The valve actuator may include a retaining feature that interacts with the hub to connect the retaining member to the hub.

Abstract: A safety needle assembly of an infusion set is disclosed. The needle assembly is configured to prevent fluid/vapor escape therefrom so as to reduce or prevent fluid exposure to a clinician using the needle assembly. In one embodiment, the needle assembly comprises a handle portion including a needle extending therefrom, the needle defining a lumen for passage of a fluid therethrough. The needle assembly also includes a safety assembly defining a needle hole through which the needle initially extends. The safety assembly is selectively and axially slidable along the needle in order to shield a distal tip of the needle and prevent user contact therewith. A fluid isolation component is included in the safety assembly for isolating fluid escape from the needle. In another embodiment, an interface pad is included on the bottom of the needle assembly and includes an antimicrobial and/or haemostatic agent to protect the needle insertion site.

Abstract: Tear-away sheath introducers for catheters, methods for making such introducers, and methods for using such introducers are described. A splittable sheath introducer may include a sheath, a hub disposed at a proximal end of the sheath, a valve included with the hub, and a valve actuator movable from a first position to a second position, the valve actuator opening the valve when in the second position. The valve actuator may include a retaining feature that interacts with the hub to connect the retaining member to the hub.

Abstract: A valved sheath introducer for venous cannulation, including a valve, sheath, handle and cap. The valve is configured to permit safe introduction and removal of medical instruments through the sheath introducer. The valve may have one or more anchoring members and a thickened central portion through which a slit is formed. The central portion may have one or more concave surfaces and the slit can be angled with respect to the top surface of the valve. The cap is attached to the handle, compressing a portion of the valve therebetween.

Abstract: A valved sheath introducer for venous cannulation, including a valve, sheath, handle and cap. The valve is configured to permit safe introduction and removal of medical instruments through the sheath introducer. The valve may have one or more anchoring members and a thickened central portion through which a slit is formed. The central portion may have one or more concave surfaces and the slit can be angled with respect to the top surface of the valve. The cap is attached to the handle, compressing a portion of the valve therebetween.

Abstract: A valved sheath introducer for venous cannulation, including a valve, sheath, handle and cap. The valve is configured to permit safe introduction and removal of medical instruments through the sheath introducer. The valve may have one or more anchoring members and a thickened central portion through which a slit is formed. The central portion may have one or more concave surfaces and the slit can be angled with respect to the top surface of the valve. The cap is attached to the handle, compressing a portion of the valve therebetween.

Abstract: An introducer for providing intravascular access to a patient is disclosed, and includes a dilator and sheath that are configured to prevent peelback, or “fishmouthing,” of the sheath during introducer advancement. In one embodiment, the introducer comprises a dilator including a distal tapered region, and a sheath including an inner bore that receives the dilator such that a portion of the tapered region of the dilator extends from the sheath distal end. A distal outer surface of the sheath includes a first curved portion defined by a first radius and extending proximally from the distal end of the sheath to a first end point, and a second curved portion defined by a second radius and extending proximally from the first end point to a second end point. Additionally, an interference fit is established between the dilator tapered region and the sheath distal end to further prevent sheath end deformation.

Abstract: Tear-away sheath introducers for catheters, methods for making such introducers, and methods for using such introducers are described. The sheath introducers contain movable valves that are encapsulated in a movable housing that allows the valve to move along the axis of the introducer. As the movable valve and housing travel along the axis, a portion of the hub protrudes past the valve and is exposed. As well, the sheath introducers can also contain a stationary valve and housing that can be opened to expose a portion of the hub when a conduit penetrates the stationary valve. The conduit can include a one-way valve actuator that can penetrate and open the valve, yet remain attached to a portion of the introducer when the introducer is split for removal from a patient. In both instances, the protruding portion of the hub contains a friction-free pathway for a catheter into the sheath introducer.

Abstract: A valved sheath introducer for venous cannulation, including a valve, sheath, handle and cap. The valve is configured to permit safe introduction and removal of medical instruments through the sheath introducer. The valve may have one or more anchoring members and a thickened central portion through which a slit is formed. The central portion may have one or more concave surfaces and the slit can be angled with respect to the top surface of the valve. The cap is attached to the handle, compressing a portion of the valve therebetween.

Abstract: A valved sheath introducer for venous cannulation, including a valve, sheath, handle and cap. The valve is configured to permit safe introduction and removal of medical instruments through the sheath introducer. The valve may have one or more anchoring members and a thickened central portion through which a slit is formed. The central portion may have one or more concave surfaces and the slit can be angled with respect to the top surface of the valve. The cap is attached to the handle, compressing a portion of the valve therebetween.

Abstract: A valved sheath introducer for venous cannulation, including a valve, sheath, handle and cap. The valve is configured to permit safe introduction and removal of medical instruments through the sheath introducer. The valve may have one or more anchoring members and a thickened central portion through which a slit is formed. The central portion may have one or more concave surfaces and the slit can be angled with respect to the top surface of the valve. The cap is attached to the handle, compressing a portion of the valve therebetween.

Abstract: Tear-away sheath introducers for catheters, methods for making such introducers, and methods for using such introducers are described. The sheath introducers contain movable valves that are encapsulated in a movable housing that allows the valve to move along the axis of the introducer. As the movable valve and housing travel along the axis, a portion of the hub protrudes past the valve and is exposed. As well, the sheath introducers can also contain a stationary valve and housing that can be opened to expose a portion of the hub when a conduit penetrates the stationary valve. The conduit can include a one-way valve actuator that can penetrate and open the valve, yet remain attached to a portion of the introducer when the introducer is split for removal from a patient. In both instances, the protruding portion of the hub contains a friction-free pathway for a catheter into the sheath introducer.