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 device to assist in accessing an access port that has been subcutaneously implanted in the body of a patient is disclosed. The implanted access port is accessed by a needle of a needle assembly, such as a needle-based infusion set. The insertion device may include a body having a stabilizing portion and a guide portion. The stabilizing portion stabilizes a position of the implanted access port when the body is placed on the skin of the patient atop the implanted access port. The guide portion is designed to guide a needle of the needle assembly along a predetermined path such that the needle transcutaneously pierces a septum of the implanted access port.

Abstract: Guidewire-management devices and systems thereof are disclosed herein. A guidewire-management device can include a guidewire, a first sleeve, and a second sleeve. The first sleeve can be configured for distally feeding the guidewire out of the guidewire-management device. The first sleeve can also be configured for proximally feeding the guidewire into the guidewire-management device. The second sleeve can be proximal of the first sleeve in the guidewire-management device. The second sleeve can be configured for feeding the guidewire in concert with the first sleeve. At least a length of the guidewire extending between the first sleeve and the second sleeve can be disposed within a sterile barrier configured to maintain sterility of the guidewire.

Abstract: Guidewire-management devices and systems thereof are disclosed herein. A guidewire-management device can include a guidewire, a first sleeve, and a second sleeve. The first sleeve can be configured for distally feeding the guidewire out of the guidewire-management device. The first sleeve can also be configured for proximally feeding the guidewire into the guidewire-management device. The second sleeve can be proximal of the first sleeve in the guidewire-management device. The second sleeve can be configured for feeding the guidewire in concert with the first sleeve. At least a length of the guidewire extending between the first sleeve and the second sleeve can be disposed within a sterile barrier configured to maintain sterility of the guidewire.

Abstract: Disclosed is a two-step rapid insertion central catheter (“RICC”) system that can include an introducer placement system, a docking station and a catheter placement system. The introducer placement system can place an introducer within a vasculature, which is supported by a docking station that detaches from a distal end of the introducer placement system. A catheter placement system can be configured to couple with the docking station, and a catheter can be advanced through the introducer into the vasculature. The introducer can then be split and retracted before the catheter placement system disengages the docking station. The docking station can be configured to split and disengage from the catheter. The RICC system can include a guidewire hub to prevent guidewire embolisms, collapsible sterile barriers to prevent contamination, and locking features to prevent premature advancement of guidewires, dilators and the like.

Abstract: Rapidly insertable central catheters (“RICC”) and methods thereof are disclosed. For example, a RICC can include a catheter tube, a suture wing disposed over a medial portion of the catheter tube, a hub coupled to a proximal-end portion of the catheter tube, and a number of extension legs extending from the hub. The catheter tube can include a first section in a distal portion of the catheter tube and a second section proximal of the first section. The second section of the catheter tube can include an outer layer extruded over an inner layer such that an outer diameter of the catheter tube is larger in the second section than the first section of the catheter tube. The catheter tube can have a column strength sufficient to prevent buckling when the catheter tube is inserted into an insertion site and advanced through vasculature of a patient.

Abstract: Guidewire-management devices and methods thereof are disclosed herein. A guidewire-management device can include a guidewire, a first sleeve, and a second sleeve. The first sleeve can be configured for distally feeding the guidewire out of the guidewire-management device. The first sleeve can also be configured for proximally feeding the guidewire into the guidewire-management device. The second sleeve can be proximal of the first sleeve in the guidewire-management device. The second sleeve can be configured for feeding the guidewire in concert with the first sleeve. At least a length of the guidewire extending between the first sleeve and the second sleeve can be disposed within a sterile barrier configured to maintain sterility of the guidewire. Methods of the guidewire-management devices can include a method of using a guidewire-management device such as the foregoing guidewire-management device.

Abstract: Rapidly inserted central catheters (“RICC”) and methods thereof are disclosed. For example, a RICC can include a first section in a distal-end portion of a catheter tube, a second section in the distal-end portion of the catheter tube proximal of the first section of the catheter tube, and a junction joining the first and second sections of the catheter tube. The first section of the catheter tube can be formed of a first polymeric material having a first durometer. The second section of the catheter tube can be formed of a second polymeric material having a second durometer less than the first durometer. The first section of the catheter tube can have a proximal-end portion disposed in a receptacle of the junction and solvent bonded thereto. For example, a method can include a method of making or using a RICC.

Abstract: Rapidly insertable central catheters (“RICC”) and methods thereof are disclosed. In an example, a RICC includes a catheter tube, a suture wing disposed over a medial portion of the catheter tube, a hub coupled to a proximal-end portion of the catheter tube, and a number of extension legs extending from the hub. The catheter tube can include a first section in a distal portion of the catheter tube formed of a first polymeric material having a first durometer. The catheter tube can also include a second section proximal of the first section of the catheter tube formed of a second polymeric material having a second durometer less than the first durometer. The catheter tube can have a column strength sufficient to prevent buckling of the catheter tube when inserted into an insertion site and advanced through a vasculature of a patient without use of the Seldinger technique.

Abstract: A catheter assembly includes a peripheral intravenous (“PIV”) portion that provides expedited vascular access. The catheter assembly includes an elongate catheter body defining a first lumen and includes a CVC portion, a transition portion, and a PIV portion. The PIV portion defines a relatively smaller diameter, a tapered tip, and a lumen configured to receive a needle. The needle extends through a needle access aperture, disposed through a side wall of the catheter body, through the PIV lumen, to a point beyond a distal end of the catheter body. A clinician accesses a vasculature using the needle and the PIV portion. The needle is then removed and a guidewire advanced through the lumen of the catheter body and the PIV portion into the vasculature. The CVC portion is then advanced over the guidewire into the vasculature, self-dilating the insertion site as the transition portion enters the vasculature.

Abstract: Rapidly inserted central catheters (“RICC”), and methods thereof. A RICC can include a catheter tube including a first section in a distal-end portion of the catheter tube, a second section in the distal-end portion of the catheter tube proximal of the first section, and a junction between the first and second sections of the catheter tube. The first section of the catheter tube can be formed of a first material having a first durometer. The second section of the catheter tube can be formed of a second material having a second durometer less than the first durometer. The first and second sections of the catheter tube can have a column strength sufficient to prevent buckling of the catheter tube when inserted into an insertion site and advanced through a vasculature of a patient.

Abstract: Disclosed herein is a probe head-cover applicator and method for applying a probe-head cover to a probe head of an ultrasound probe. A probe head-cover applicator can include a tray including a cavity, an insert of a compressible material suspended over the cavity, and a probe-head cover adhered to the insert. The insert can include a first adhesive on an outward-facing surface of the insert facing away from the cavity. The probe-head cover can be adhered to the insert by the first adhesive. The probe-head cover can include a second adhesive on an outward-facing surface of the probe-head cover facing away from the insert. The second adhesive can be configured to adhere the probe-head cover to a probe head of an ultrasound probe when the probe head is inserted into the cavity.

Abstract: Medical device kits for use in placing, maintaining, altering, and/or removing medical devices in, on, and/or from the body of a patient are disclosed. Such medical device kits can include one or more wrap assemblies for use in the placement/maintenance procedure. In accordance with present embodiments, the one or more wrap assemblies of the medical device kit can include various features to assist the clinician performing the particular procedure. In one embodiment, a medical wrap assembly is disclosed, comprising a foldable wrap body that includes a front surface, wherein the front surface is configured to define a sterile field. A plurality of pockets is included on the front surface of the wrap body. The pockets are configured to contain therein a plurality of medical components. The medical components are arranged in the pockets in a predetermined order of use for the medical procedure.

Abstract: Embodiments disclosed herein are directed to a system including an intravenous (IV) pump, a vascular access device (VAD), securement devices, and methods thereof. The intravenous (IV) pump, vascular access device (VAD), and securement device can include a sensor, printed circuit board (PCB), communication module, and the like to determine the characteristics of the VAD device in use, the fluid being administered, and physiological characteristics of the patient. The pump unit can utilize this information to modify the flow characteristics of the fluid being administered. The VAD characteristics can be predetermined and stored on the VAD, derived from sensors, or derived from remote databases using a unique identifier. Fluid and physiological characteristics can be determined from sensors located on the pump, VAD, securement device or combinations thereof.

Abstract: A medical article, such as a catheter, is secured with respect to a patient with a securement device. The securement device may include a retainer and anchor pad. Certain devices may further include, for example, straps, flaps, dressings, slots, and recesses for securing the medical article to the patient. The retainer may include a recess and/or a channel. At least one surface of the retainer may be coated with an adhesive. A support member may be coupled to the retainer. The support member may include a channel configured to receive a proximally extending portion of the medical article.

Abstract: Embodiments disclosed herein are directed to a securement device including a retainer defining a channel and at least one mounting wing extending therefrom. The mounting wing extends distally of an insertion site a skin surface adjacent to the insertion site to prevent “rocking” or “pistoning.” The mounting wing further includes channels of reduced thickness configured to impart malleable properties on the mounting wing. This can allow the mounting wing to be shaped to fit different portions of the patient. The retainer further includes various locking and anti-rotational features to guide the catheter into position within the retainer and further prevent “rocking” or “pistoning.” The securement device also includes a protective pad to inhibit abrasions from a medical line, spin nuts, and the like, and includes a clasping feature to retain a portion of the release liner to prevent obstructing ingress/egress of the catheter.

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: Medical device kits for use in placing, maintaining, altering, and/or removing medical devices in, on, and/or from the body of a patient are disclosed. Such medical device kits can include one or more wrap assemblies for use in the placement/maintenance procedure. In accordance with present embodiments, the one or more wrap assemblies of the medical device kit can include various features to assist the clinician performing the particular procedure. In one embodiment, a medical wrap assembly is disclosed, comprising a foldable wrap body that includes a front surface, wherein the front surface is configured to define a sterile field. A plurality of pockets is included on the front surface of the wrap body. The pockets are configured to contain therein a plurality of medical components. The medical components are arranged in the pockets in a predetermined order of use for the medical procedure.

Abstract: A medical article, such as a catheter, is secured with respect to a patient with a securement device. The securement device may include a retainer and anchor pad. Certain devices may further include, for example, straps, flaps, dressings, slots, and recesses for securing the medical article to the patient. The retainer may include a recess and/or a channel. At least one surface of the retainer may be coated with an adhesive. A support member may be coupled to the retainer. The support member may include a channel configured to receive a proximally extending portion of the medical article.

Abstract: A guidance system for assisting with the insertion of a needle into a patient body utilizing ultrasound imaging or other suitable imaging technology. The guidance system can include an imaging device including a probe for producing an image of an internal body portion target, such as a blood vessel. One or more sensors can be included with the probe. The sensors can sense a detectable characteristic related to the needle, such as a magnetic field of a magnet included with the needle. The system can include a processor that uses data relating to the sensed characteristic to determine a 3-D position of the needle. The system can include a display for depicting the position of the needle. A needle assembly including a hub, cannula, and magnetic element is also disclosed, wherein a magnetic axis of the magnetic element is configured to be coaxially aligned with the needle cannula.