Abstract: An information bearing septum viewable under radiographic imaging is formed by molding a septum base to have a depression with a given configuration and molding a one-piece solid radiopaque material insert having the same given configuration. The radiopaque insert is mounted to the cavity formed by the depression at the septum base. The top of the septum is then covered by a silicone layer that bonds to the septum. The finished septum is adapted to be fitted to a reservoir housing of a subcutaneous implantable portal. In place of the solid insert, the septum may be formed by placing on top of the septum base a one-piece top layer impregnated with a radiopaque material that has an integral hanging insert that fittingly mounts into the cavity formed by the depression at the septum base.

Abstract: Embodiments relate to systems, methods and devices for delivering a drug or other therapy to a patient with an ambulatory infusion pump configured to provide a series of tolerance-building steps leading up to a plateau delivery rate. The plateau delivery rate is maintained until the prescribed amount of drug or therapy fluid is delivered to the patient. Embodiments of the invention include providing the patient or other user with a mechanism to decrease, or step down, the therapy delivery rate if a tolerance was not achieved at a lower rate, and providing notifications prior to a step up in a dosage delivery rate.

Abstract: An access device for placing a medical article within a body space includes a syringe, a needle, and a sheath which are employed together with a guide wire. The sheath can be coaxially and slideably disposed about the needle. During insertion of the sheath over the needle, guide wire and into the body space, the syringe provides a negative pressure to ensure that any air located between the inside diameter of the sheath and the outside diameter of the needle is drawn into the needle rather than into the body space. In certain embodiments, a dilator is coaxially and slideably disposed about the needle and within the sheath.

Abstract: An implantable portal includes a septum that has embedded therein an indicia adapted to identify at least one characteristic of the portal. The indicia may be formed as an impression at a base layer of the septum, and is filled with a radiopaque material. The septum base layer is covered by liquid silicone, which bonds with the septum base layer when solidified, so that an integral one-piece septum, with the identifier indicia embedded therein, is effected. The indicia embedded septum is fitted to the reservoir housing of the portal for providing identification information for that portal. The septum embedded indicia is viewable visually and also by x-ray or computer tomography imaging.

Abstract: A needle assembly. The needle assembly enabling the analysis of fluid trapped in a flashback chamber after an insertion needle has been inserted into a patient's vein.

Abstract: A medication safety device and method can include an infusion pump and a drug library in communication with the infusion pump. The drug library can have upper hard and soft limits and lower hard and soft limits associated with at least one drug. A graphical user interface can display a bar chart showing upper and lower soft limit bars for the at least one drug. The upper and lower soft limit bars can be grabbed and dragged on the graphical user interface in touch-screen fashion to new positions associated with new upper and lower soft limits. The graphical user interface and associated hardware and software can be configurable to responsively re-analyze data and compare a particular infusion to the new upper and lower soft limits.

Abstract: A splittable sheath includes a splittable sheath body, a splittable sheath hub, and a valve element. The sheath body comprises a generally flexible tubular structure, a proximal end, and a distal end. The sheath body defines a longitudinal axis and is splittable into two halves along a pre-determined line generally parallel to the longitudinal axis. The sheath hub extends from the proximal end of the sheath body and defines a longitudinal axis generally aligned with the longitudinal axis of the sheath body. The sheath body and sheath hub form an inner cavity along their respective longitudinal axes. The valve element includes a resilient plate and a sealing element. The resilient plate includes a distal portion extending radially inwardly from a side of the inner cavity.

Abstract: An access device for placing a medical article within a body space includes a needle, a dilator, and a medical article. The needle can include an elongated needle body with a distal end and a hub from which the needle body extends. The elongated needle body can include at least one side fenestration and an outer diameter. The dilator can be slideably disposed on the needle body and include a dilator hub and an elongated dilator shaft that extends from the dilator hub. The dilator shaft can include at least one side fenestration in communication with the needle side fenestration. The dilator shaft can also include an inner diameter that is less than the outer diameter of the needle. The medical article can include a tubular section and a hub. The tubular section can be disposed on the dilator and define a space between the medical article and the dilator in communication with the needle side fenestration through the dilator side fenestration.

Abstract: Improved tip protector assemblies (TPAs) and catheter hubs are provided for use with I.V. catheters. An improved TPA includes an upstanding push tab configured to facilitate one-handed placement of the catheter. The disclosure also provides a hinging push tab usable to fluidically seal or at least cover the proximal fitment of a catheter hub once the catheter is placed and the TPA removed. Improved TPAs are disclosed that mitigate off-axis loading and accidental premature detachment from the catheter hub.

Abstract: A method of making a flexible medical article or tube, for example, a sheath for a vascular access device, is provided. The method can include extruding a polymer, for example, a polycarbonate-urethane copolymer, to form a tube and annealing the extruded polymer. The method can further include cutting the extruded tube to a desired length before or after annealing, flaring one end of the annealed tube and over-molding the flared portion onto a hub, and forming the other end of the tube into a tip. A sheath formed by such a method is also provided.

Abstract: A needle assembly for sampling fluid from a patient including a needle guard, an insertion needle, and a needle housing. The distal end of the needle guard includes a nose portion and a flexible nose extension defining a fluid collection reservoir. The proximal end of the needle guard includes a push feature. The insertion needle has a sharpened distal tip, a proximal needle end and a shaft defining a lumen extending therebetween. The needle housing is operably coupled to the proximal needle end and is slideably coupled to the needle guard. The needle housing includes a flash chamber including a wall defining a cavity. The cavity is in fluid communication with the lumen of the insertion needle and is sealed at one end by a gas permeable flash plug. The push feature selectively engages the flash plug to divert captured bodily fluids to the fluid collection reservoir for sampling.

Abstract: In various embodiments, an improved catheter insertion device is described that provides an improved flashback response and use for deep vein access. In various embodiments, the improved flashback response comprises two separate and distinct flash events, the first indicating insertion of a cannula in a blood vessel, and a second indicating insertion of a catheter in the blood vessel. The two flash responses are made possible by a combination of features provided on the cannula, such as including a view window in the cannula and a flat relief portion on the outer surface of the cannula at the distal opening.

Abstract: A catheter assembly includes a catheter hub defining an interior cavity and a catheter tube extending distally thereof. A rigid actuator is positioned to extend proximally in the interior cavity and support a seal member positioned thereon in the interior cavity. The seal member includes a central membrane, a distal portion, and a proximal portion. An hourglass shaped actuator cavity is formed in the distal portion and receives a barbed end of the actuator. The outer surface of the seal member is in partial circumferential engagement with the catheter hub to define an air path that allows fluid communication between areas of the interior cavity distal and proximal of the seal member. The seal member may be configured for multi-use and include a biasing member that moves the seal member to force the membrane back over the actuator to close the membrane.

Abstract: A fitting has a first end conventional connector and a second end non-conventional connector of a given configuration that is matable only to a counterpart non-conventional connector having a configuration complementary to the given configuration. The body of the fitting has two extending wings that merge with a partition that separates the conventional connector from the body. A label may be mounted about the neck extension of the male connector to convey information to the user. The portion along the fitting between the label and the partition provides a location whereat the user can position his fingers to grasp the fitting. The partition prevents the fingers of the user from coming into contact with and contaminating the conventional connector, while the label, in addition to conveying information to the user, also acts a barrier to prevent contamination of the non-conventional connector by the fingers of the user.

Abstract: A syringe pump configured to mechanically align a force sensor with an axis of a plunger of a syringe for a purpose of minimizing force measurement inaccuracies. The syringe pump includes a syringe pump housing that is configured to receive at least a portion of said syringe, wherein the syringe is selected from a plurality of syringes of different dimensions. A plunger retainer mechanism is pivotably coupled to the syringe pump housing and is configured to retain said plunger of said syringe. The plunger retainer mechanism pivots relative to the syringe pump housing based on a sensed dimension of the plunger to align a force sensor coupled to the plunger retainer mechanism with the axis of the plunger; and a syringe drive mechanism is operably coupled to the syringe pump housing and configured to shift the plunger relative to the portion of the syringe received by the syringe pump housing.

Abstract: The present disclosure provides for a safety catheter assembly comprising a needle hub, a catheter hub, a tip protector housing. Various embodiments can comprises a push-off tab extending radially from the tip protector housing or a portion thereof, and/or structure can be added or removed to affect compliance between a catheter assembly and a catheter insertion device.

Abstract: An intravenous catheter assembly that includes a catheter tube and an introducer needle that is disposed, at least in part, within the catheter tube when the introducer needle is in a ready for use position. The introducer needle includes a lateral surface that defines a relief that is positioned under the distal end of the catheter tube when the introducer is in the ready for use position to provide a flow path into a flash indication space.

Abstract: A medication safety device and method can include an infusion pump and a drug library in communication with the infusion pump. The drug library can have upper hard and soft limits and lower hard and soft limits associated with at least one drug. A graphical user interface can display a bar chart showing upper and lower soft limit bars for the at least one drug. The upper and lower soft limit bars can be grabbed and dragged on the graphical user interface in touch screen fashion to new positions associated with new upper and lower soft limits. The graphical user interface and associated hardware and software can be configurable to responsively re analyze data and compare a particular infusion to the new upper and lower soft limits.