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: Push activated intraosseous (IO) access devices include power sources such as battery packs or spring driven devices. Intraosseous access devices often require training to ensure correct placement of the access device. The disclosed devices include an intuitive operation with a unidirectional activation and drive force application. The trigger can be both activated and deactivated automatically to prevent premature activation and prevent “backwalling”. The device can include various indicators to further guide a user in placing the device correctly, with little or no training. Devices can further include replaceable battery packs to ensure a full charge is available when the device is used, and to provide a multi-use device that requires less storage.

Abstract: A guidance system for assisting with the insertion of a needle into a patient is disclosed. The guidance system utilizes 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 target, such as a vessel. One or more sensors can be included with the probe. The sensors 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, and a display for depicting the position of the needle. A needle assembly including a hub, cannula, and magnetic element is also disclosed, in which a magnetic axis of the magnetic element can be configured to be coaxially or otherwise aligned with the cannula axis.

Abstract: An ultrasound probe for sustained spatial attention. The ultrasound probe can include a display screen on a visible side of the ultrasound probe, the display screen coupled to ultrasound imaging components in the ultrasound probe, the ultrasound imaging components configured to capture live subcutaneous images and render the live subcutaneous images on the display screen. The ultrasound probe can further include one or more needle trajectories depicted on the display over the live subcutaneous images, the one or more needle trajectories configured to assist a user in guided insertion of a needle into an anatomical target under the ultrasound probe. The ultrasound probe can further include a light-pattern projector on the visible side of the ultrasound probe adjacent the display screen, the light-pattern projector configured to project a light pattern corresponding to a subcutaneous depth accessible by a needle.

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: An apparatus and method for a stepped needle for an intraosseous device that uses the outer surface of the bone cortex as a reference point. Since the thickness of the bone cortex does not vary significantly between patients, the accuracy of needle placement can be improved. The device includes a needle with a stepped increase in outer diameter disposed along the needle shaft. The abrupt change in outer diameter provides a substantial increase in insertion force. The stepped increase prevents any further insertion into the bone cortex. Embodiments can include a tapered needle lumen for medullary access confirmation and an overtube that is rotatably and slidably engaged to protect surrounding tissues and prevent needle stick injuries. Further, a needle hub can be rotatable or slidable, and can transition an overtube to an extended position to prevent accidental needle stick injuries.

Abstract: An intraosseous system and methods for accessing a medullary cavity. The intraosseous system can include an access assembly and an advancement assembly. The access assembly can include an obturator assembly coupled to a needle assembly. The advancement assembly can include a housing having an inner wall and a drive screw coupled to an energy source. The drive screw can include a threaded portion extending from a drive screw head. The threaded portion can extend into the housing. The advancement assembly can further include an advancement nut threadably engaged with the threaded portion of the drive screw. The advancement nut can include an outer surface configured to slide along the inner wall a predetermined distance without rotating. The advancement assembly can further include a socket configured for attachment to the access assembly.

Abstract: Advanced catheter placement systems require disengaging a needle from the guidewire without disturbing a position of the guidewire within the vasculature. Embodiments include withdrawing the needle proximally and drawing the needle over a splitter system that includes a splitter wedge. The splitter system separates the needle along a longitudinal axis. A portion of the guidewire can then pass between a first portion and a second portion of the needle, allowing the needle to disengage the guidewire. A catheter disposed on a proximal portion of the guidewire can then be advanced thereover into the vasculature. A needle safety system can adhere a puncture-resistant adhesive tape to the split portions of the needle. The tape can encapsulate the portions of the needle mitigating any damage or trauma caused by sharpened edges of the needle portions.

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: Disclosed herein is a catheter, which in some embodiments includes a distal section configured to enter a skin insertion site. The distal section can include a tapered junction having one or more dilation structures configured to dilate the skin insertion site. The distal section can further include a distal portion extending from a distal end of the tapered junction, the distal portion having a diameter smaller than a proximal portion of the catheter. In combination, the tapered junction, the one or more dilation structures, and the specific actions of the user urging the catheter into the insertion site can result in an improved fit of the catheter in the insertion site.

Abstract: An intraosseous access device can include a device body, a trocar needle coupled to the device body, and an intraosseous catheter removably disposed on the trocar needle. The device body can be configured to enable manual insertion of a distal tip of the trocar needle through a skin surface of a patient to an external surface of a bone of the patient. The intraosseous catheter can include a catheter hub and a cannula slidable with respect to the catheter hub to enable adjustment of a longitudinal length of the intraosseous catheter. The intraosseous access device can further include an advancement mechanism configured to advance the trocar needle and the intraosseous catheter into an internal portion of the bone after the distal tip of the trocar needle and the intraosseous catheter have been inserted through the skin surface of the patient to the external surface of the bone of the patient.

Abstract: A mechanical dilator is disclosed, which can include a first arm coupled to a second arm by a fulcrum, the first arm and the second arm cooperatively defining a lock and stop mechanism configured to limit lateral movement of the first arm with respect to the second arm. The mechanical dilator can further include a dilator body having a first side extending from the first arm and a second side extending from the second arm, where the fulcrum is configured to translate lateral movement of the first arm relative to the second arm to lateral movement of the first side relative to the second side.

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: Disclosed herein is a catheter, which in some embodiments includes a distal section configured to enter a skin insertion site. The distal section can include a tapered junction having one or more dilation structures configured to dilate the skin insertion site. The distal section can further include a distal portion extending from a distal end of the tapered junction, the distal portion having a diameter smaller than a proximal portion of the catheter. In combination, the tapered junction, the one or more dilation structures, and the specific actions of the user urging the catheter into the insertion site can result in an improved fit of the catheter in the insertion site.

Abstract: An intraosseous access device can include a constant-torque spring assembly disposed in a housing, a drive shaft extending from the housing, and an intraosseous needle coupled to the drive shaft configured to provide intraosseous access to a medullary cavity of a patient. A method of using an intraosseous access device can include inserting a distal end of the intraosseous needle through skin at an insertion site of a patient and applying a contacting force to a bone beneath the insertion site with the distal end of the intraosseous needle. The contacting force can initiate a winding of a ribbon of the constant-torque spring assembly from an output spool onto a storage spool, thereby initiating drilling rotation of the intraosseous needle. The method can further include drilling through the bone until the intraosseous needle enters a medullary cavity of the patient.

Abstract: A safety mechanism for an obturator having a sharp distal tip and a notch proximal to the sharp distal tip. The safety mechanism includes a sheath and clip combination configured to releasably couple to a needle hub. The clip is configured to transition between a coupled configuration and an uncoupled configuration. The clip can include a first arm including a first keyhole aperture and a second arm including a second keyhole aperture. The clip can further include a biasing member connecting the first arm to the second arm, the biasing member configured to bias the clip toward the uncoupled configuration. The first keyhole aperture and the second keyhole aperture are configured to slidingly receive the obturator. The clip can transition from the coupled configuration to the uncoupled configuration when the first keyhole aperture and the second keyhole aperture engage the notch.

Abstract: An insertion device includes a housing, a sheath, a guidewire, and a wheel assembly. The housing has a distal opening at a distal end and a proximal opening at a proximal end. The sheath is coupled to the proximal end of the housing and has an interior in communication with a proximal opening of the housing. The guidewire extends through the proximal opening and into the sheath. The guidewire includes a feature to limit distal advancement of the guidewire. The wheel assembly is rotatably coupled to the housing and connected to the guidewire such that rotation of the wheel assembly distally advances the guidewire through the distal opening of the housing.

Abstract: Push activated intraosseous (IO) access devices include power sources such as battery packs or spring driven devices. Intraosseous access devices often require training to ensure correct placement of the access device. The disclosed devices include an intuitive operation with a unidirectional activation and drive force application. The trigger can be both activated and deactivated automatically to prevent premature activation and prevent “backwalling”. The device can include various indicators to further guide a user in placing the device correctly, with little or no training. Devices can further include replaceable battery packs to ensure a full charge is available when the device is used, and to provide a multi-use device that requires less storage.