Abstract: Rapidly insertable central-catheter (“RICC”) insertion assemblies and associated methods include valve modules. For example, a RICC insertion assembly can include a RICC, an introducer needle, and an access guidewire coupled together by a coupler in which a valve module is disposed. The introducer needle includes a needle shaft having a longitudinal needle slot and a sheath over the needle shaft sealing the needle slot thereunder except for that under a sheath opening of the sheath. The valve module includes an elastomeric gasket encircling at least a portion of a valve-module compartment of the coupler housing. In a ready-to-deploy state of the RICC insertion assembly, the gasket is compressed in the valve-module compartment around both the introducer needle and the access guidewire where the access guidewire extends from the sheath opening, thereby creating a substantially air-tight space within the gasket around the introducer needle and the access guidewire.

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: A catheter containment device configured to retain a proximal portion of a catheter placement system, such as a catheter, hub, extension leg, luer lock, or guidewire. The device includes a handle configured to engage a digit of the clinician to couple the device and the proximal portion of a catheter placement system thereto. This allows the clinician to retain the proximal portion within the sterile field without reducing dexterity or obstructing the clinician's view of the insertion site or the catheter placement system. Further the device can allow the clinician to manipulate the proximal portion of the catheter system while mitigating dropping or tangling.

Abstract: A catheter containment system configured for securing a proximal portion of a catheter placement system within a sterile field. This relieves the clinician from holding the proximal portion to prevent them for falling outside of the sterile field. Further, the proximal portion can be secured out of the way from the insertion site providing a clear field of view. Embodiments include a body, having a channel configured to releasably engage an extension leg or guidewire, and a securement feature to secure the body to a portion of a drape or similar item of the sterile field. Exemplary securement features can include clips, clasps, pins, magnetic elements, adhesives, twist ties, zip ties, snap fasteners, hook and loop attachments, mechanical grasping devices or adhesive pads. The system can further include anchor tabs that can be adhered to the drape to provide an anchor point.

Abstract: Assemblies of guidewires for automatic withdrawal of stylets can include stylet and catheter assemblies. For example, a stylet assembly can include a guidewire disposed in a stylet. The guidewire can include a proximal portion having a first outer diameter, a distal portion including a dilated section having a second outer diameter greater than the first outer diameter, and a guidewire tip in the distal portion of the guidewire. The stylet can include a stylet tip and a stylet lumen therethrough with a stylet inner diameter commensurate with the first outer diameter of the guidewire. At least the proximal portion of the guidewire can be disposed in the stylet lumen of the stylet with a corresponding orientation. The dilated section of the guidewire can be configured to butt against the stylet tip when the guidewire is proximally withdrawn from a catheter for automatic withdrawal of the stylet from the catheter.

Abstract: A rapidly insertable central catheter (“RICC”) insertion assembly can include a RICC, an introducer needle, a coupler coupling the RICC and the introducer needle together, and a sheath-splitting means for splitting a sheath body of the introducer needle away from an access guidewire. The sheath-splitting means allows the access guidewire to escape from the sheath body and remain in a needle tract established with the introduce needle. The splitting of the sheath body by the sheath-splitting means can be initiated by withdrawing the sheath body by a pair of finger tabs extending from a sheath hub around the proximal portion of the sheath body, twisting the introducer needle or a needle hub around the proximal portion of the needle shaft, triggering one or more triggers disposed in the coupler housing, or pushing a catheter tip of the RICC into the sheath body.

Abstract: An introducer needle can include a needle shaft, a sheath over the needle shaft, and a needle hub around a proximal portion of each of the needle shaft and the sheath. The needle shaft can include a needle slot extending from the proximal portion of the needle shaft through a distal needle tip, which needle tip can include a bevel having a tip bevel and a heel. The needle shaft can include opposite needle-slot walls that either: a) face each other and are parallel or oblique to each other, or b) face toward or away from a bottom of the needle slot. Additionally or alternatively, opposite needle-shaft walls can be parallel to each other. The sheath over the needle shaft can seal the needle slot thereunder but for a sheath opening in a proximal portion of the sheath.

Abstract: Introducer needles can be used with rapidly insertable central catheters (“RICCs”) or even other central venous catheters (“CVCs”). An introducer needle can include a needle shaft, a sheath, and a needle hub. The needle shaft can include a needle slot extending from a proximal portion of the needle shaft through a distal needle tip. The sheath can be disposed over the needle shaft and fixed in location thereon. The sheath can seal the needle slot under the sheath but for a sheath opening in a proximal portion of the sheath. The needle hub can be around at least the proximal portion of the needle shaft. The introducer needle can be made by creating the needle slot in the needle shaft such as by cutting or grinding the needle slot therein, disposing the sheath over the needle shaft, and fixing the sheath on the needle shaft.

Abstract: An introducer assembly can include an introducer and an access guidewire disposed therein. An introducer needle of the introducer can include a needle shaft having a needle slot extending from a proximal portion of the needle shaft through a distal needle tip. An introducer sheath of the introducer can include a sheath body over the needle shaft sealing the needle slot thereunder but for a sheath-body opening in a proximal portion thereof. The access guidewire can include a distal-end portion disposed in the introducer having an outer diameter greater than a proximal-end portion of the needle slot such that the proximal-end portion of the needle slot catches the distal-end portion of the access guidewire preventing proximal withdrawal of the access guidewire from the needle shaft. A method can include inserting a rapidly insertable central catheter into a blood-vessel lumen of a patient with the introducer assembly.

Abstract: A rapidly insertable central catheter (“RICC”) insertion assembly having a sealing module can include a RICC, an introducer needle, an access guidewire, and a coupler coupling the RICC and the introducer needle together. A proximal portion of the access guidewire is disposed in a primary lumen of the RICC. A distal portion of the access guidewire is disposed in a needle shaft of the introducer needle through a needle slot thereof. A coupler housing of the coupler includes a sealing-module cavity of the sealing module. An elastomeric sealing-module insert of the sealing module is inserted into the sealing-module cavity. The sealing-module insert is configured to separately seal around a proximal portion of the introducer needle and the distal portion of the access guidewire when the sealing-module insert is compressed in the sealing-module cavity. A method can include inserting the foregoing RICC into a blood-vessel lumen of a patient.

Abstract: A guidewire stabilization mechanism for a catheter placement system can include an actuator button that can be actuated by the user to grip the guidewire in a locked position. With the guidewire locked relative to a housing of the stabilization mechanism a user can detach a needle hub from the housing and withdraw the needle proximally. A portion of the guidewire can pass through a needle slot to disengage the needle from the guidewire. The stabilization mechanism can prevent the guidewire from being dislodged from the vasculature as the needle is withdrawn. The stabilization mechanism can be biased towards the unlocked position, towards the locked position, can be bistable in both the locked and unlocked positions, or can be activated by the removal of the needle.

Abstract: Disclosed herein are couplers and assemblies thereof for rapidly insertable central catheters (“RICCs”). For example, an introducer-needle assembly for a RICC can include an introducer needle and a coupler coupled therewith. The introducer needle can include a needle having a longitudinal needle slot extending from a proximal portion of the needle shaft through a distal needle tip. A sheath can be over the needle shaft sealing the needle slot thereunder except for a portion of the needle slot under a sheath opening in a proximal portion of the sheath. A needle hub can include a distally extending needle-hub extension arm over the proximal portions of the needle shaft and sheath. The needle hub can also include a needle-hub portion of a RICC clip configured to hold a portion of the RICC therein. The coupler can include a complementary coupler portion of the RICC clip connected to a coupler housing.

Abstract: Disclosed are compact rapidly insertable central catheter (“RICC”) insertion assemblies and methods. For example, a RICC insertion assembly can include a RICC, an introducer assembly, an access guidewire, and a coupler coupling together the RICC and the introducer assembly. The RICC can include a catheter tube, a catheter hub, and one or more extension legs connected in the foregoing order. The introducer assembly can include an introducer needle coupled to a syringe. The introducer needle can include a needle-hub through hole passing through a needle hub and connecting to a needle-shaft lumen of a needle shaft. The access guidewire can include a proximal portion disposed in the RICC and a distal portion disposed in the needle-shaft lumen through the needle-hub through hole. The coupler can enforce a loop in the access guidewire over which the catheter tube follows, thereby compacting the RICC insertion assembly and making it easier to handle.

Abstract: Disclosed are insertion assemblies of rapidly insertable central catheters (“RICCs”) and methods thereof. For example, a RICC insertion assembly can include a RICC, an introducer needle, an access guidewire, and a coupler assembly coupling the foregoing together. The introducer needle can include a needle hub over both a sheath and a needle shaft. The sheath can seal a needle slot except for that under a sheath opening. A distal end of the access guidewire can be disposed in the introducer needle just proximal of a needle tip. The coupler assembly can include a nose piece and a tail piece coupled together. The tail piece can include an extension arm by which a proximal end of the access guidewire is held. The access guidewire can enforce a loop in the access guidewire over which the RICC is disposed, thereby keeping the RICC insertion assembly in a relatively compact form.

Abstract: Disclosed are splittable sealing modules for insertion assemblies of rapidly insertable central catheters (“RICCs”) and methods thereof. A RICC insertion assembly can include a RICC, an introducer needle, an access guidewire, and a coupler coupling the RICC and the introducer needle together. The introducer needle can include a proximal portion of a sealing-module insert coupled to a distal portion of a needle hub. The coupler can include a coupler housing including a sealing-module cavity and a distal portion of the sealing-module insert disposed in the sealing-module cavity. The sealing-module cavity and the proximal and distal portions of the sealing-module insert form a splittable sealing module of the RICC insertion assembly. The splittable sealing module can be configured to separately seal around the introducer needle and the access guidewire disposed therein when the proximal and distal portions of the sealing-module insert are compressed in the sealing-module cavity.

Abstract: Disclosed herein are couplers and assemblies thereof for rapidly insertable central catheters (“RICCs”). For example, a coupler assembly can include an introducer needle and a coupler coupled together. The introducer needle can include a needle hub over both a needle shaft and a sheath over the needle shaft. The needle shaft can include a longitudinal needle slot extending through a distal needle tip. The sheath can seal the needle slot thereunder except for the needle slot under a sheath opening in a proximal portion of the sheath. The needle hub can include a needle-hub clip. The coupler can include a coupler housing and an extension arm connected to the coupler housing. The needle-hub clip can be clipped onto the coupler housing in at least a ready-to-deploy state of the coupler assembly. The extension arm can be configured for attaching a proximal end of an access guidewire thereto.

Abstract: Disclosed are rapidly insertable central catheter (“RICC”) insertion assemblies and methods. For example, a RICC insertion assembly can include a RICC, an access guidewire, an introducer needle, and a coupler coupling the foregoing components together. The introducer needle can include a needle shaft and a sheath. The needle shaft can include a longitudinal needle slot. The sheath can seal the needle slot thereunder except for a sheath opening thereto in a proximal portion of the sheath. The coupler can include a coupler housing and a valve module disposed in the coupler housing. The valve module can seal the needle shaft and the sheath therein. The access guidewire can include a proximal end coupled to the coupler and a distal end disposed in the introducer needle, thereby enforcing a loop in the access guidewire. The RICC can be disposed over the loop in a ready-to-deploy state of the RICC insertion assembly.

Abstract: Rapidly insertable central catheters (“RICCs”), introducers, and insertion devices including combinations and methods thereof are disclosed. For example, a RICC system can include an introducer and a RICC insertion assembly including a RICC assembly disposed in a RICC insertion device. The RICC assembly can include a RICC, an access guidewire, and a splittable casing over a catheter tube of the RICC and the access guidewire forming a longitudinal composite. The RICC insertion device can include a frame and a nose cover forming a split channel that splits away from a through channel of a nose of the frame. The RICC insertion device can be configured for advancing the RICC assembly by rolling the longitudinal composite across roller wheels disposed in the frame. The through channel can be configured for advancing the catheter tube therethrough while the split channel can be configured for both splitting and passing the splittable casing therethrough.

Abstract: Embodiments of catheter placement systems described herein include a temporary splittable sheath anchor, disposed on an outer surface of a needle. The splittable anchor moves with respect to the needle when accessing the vessel, allowing for a temporary anchor to be created as soon as venous access is confirmed via flashback. The clinician can advance the anchor over the needle once vessel access has been confirmed by flashback. The needle can then be removed without further insertion into the vessel, mitigating accidental trauma. The guidewire can then be introduced through the anchor and advanced to a target location within the vasculature. The anchor can then be removed by splitting and withdrawing the anchor proximally. Embodiments further include a splittable advancement sheath including a guidewire and configured to be drawn thorough a housing and split to allow the guidewire to separate from the advancement sheath and advance into the vasculature.