Abstract: Rapidly insertable central catheters (“RICCs”) including catheter assemblies and methods thereof reduce both steps and medical devices involved in introducing a catheter. A RICC assembly can include a RICC, an introducer, and a coupling system coupling the RICC and the introducer together. A catheter tube of the RICC can include a side aperture in a distal-end portion of the catheter tube, which opens into an introducing lumen extending from the side aperture to a distal end of the RICC. The introducer can include an introducer needle having a cannula. The coupling system can include a distal coupler slidably attached to the catheter tube. The cannula can extend through a longitudinal through hole of the distal coupler, through the side aperture of the catheter tube, along the introducing lumen of the catheter tube, and through the distal end of the RICC when the RICC assembly is in a ready-to-deploy state thereof.

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-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: 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: The ultrasound probe cover system comprises a cradle arm supporting an ultrasound probe in a predetermined position, a first applicator arm articulating relative to the cradle arm and housing a sterilizer applicator and a gel applicator for applying a sterilizing agent and a gel to the probe head, and a sheath arm with a sheath holder supporting an open sheath. The sheath arm articulates relative to the cradle arm to position the sheath opening over the probe head. The sheath includes a biasing member extending helically and configured to bias the sheath to an extended configuration to facilitate placing the sheath over the probe. The cover system provides a convenient and efficient solution for covering and preparing ultrasound probes for medical procedures, enhancing hygiene and usability in healthcare settings.

Abstract: With smaller gauge catheters, forming distal tip structures, termed “tipping,” can be increasingly challenging. The thin wall-thicknesses of these small gauge catheters provide a reduced cross-sectional surface area with which to couple the distal tip structure to. This increases the risk of failure of the device either during manufacture or during use. To address the foregoing, embodiments include forming and placing a spiral plug within a lumen of a proximal section of the catheter. The spiral plug co-operates with the catheter to provide an increased wall thickness and an increased cross-sectional surface area with which to couple a distal tip structure thereto. Further the spiral plug can align the lumen of the catheter body with a lumen of the distal tip structure. The spiral plug can be sacrificial and provide increased material across the joint, mitigating joint failure.

Abstract: Disclosed herein are portal-establishing devices and methods thereof for establishing portals in procedural barriers. For example, a portal-establishing device includes a portal and a breaching mechanism. The portal includes a portal barrier in a protruding-end portion thereof. The portal is configured to enable one or more functional connections such as an optical connection or an electrical connection across a procedural barrier between a single-use medical device on a clinician-facing side of the procedural barrier and another medical device on a patient-facing side of the procedural barrier. The breaching mechanism is configured to breach the procedural barrier and place the portal over a breach in the procedural barrier. Methods of the portal-establishing devices include methods of using the portal-establishing devices.

Abstract: A catheter placement system including a catheter, a needle for creating an insertion site, and a skin nicking device for enlarging the insertion site. A catheter placement device includes the skin nicking device slidably coupled with the needle, where the skin nicking device has one or more blades attached to a frame thereof. Distally displacing the skin nicking device along the needle causes the blade to nick the skin to enlarge the insertion site. A shield of the skin nicking device transitions between a safe configuration encapsulating the blade and a use configuration exposing the blade and the shield may be biased toward the safe configuration. A latch secures the shield in the safe configuration and an actuator releases the latch. A sheath of the skin nicking device includes the needle slidably disposed within a lumen thereof and a sharp tip of the blade embedded within a wall thereof.

Abstract: Embodiments disclosed herein are directed to a fiber-optically enabled medical device system including an optical fiber and one or more conductive elements. The optical fiber is configured to determine a shape of the medical device as the device negotiates tortuous vascular pathways. The one or more conductive elements can be configured to transmit electrical signals there along between the distal tip and a console coupled to a proximal end of the medical device. The electrical signals can determine a location of a tip of the medical device, detect an electrophysiological signal at a distal tip, and/or provide electro-stimulation or ablation energy to the distal tip of the medical device. The one or more conductive elements can be a wire extending linearly or helically about the optical fiber, or can be a tube, or tube section, extending annularly about the optical fiber, or combinations thereof.

Abstract: A medical ultrasound system and methods of using the system. The medical ultrasound system can include an ultrasound probe and one of a plurality of optional accessories attached to the ultrasound probe. The accessory can exchange data with the probe and receive power from the probe. The accessory can include processors and logic that governs its operation thereby adding functionality to the probe. The accessory can receive input and provide output via any of a number of communication mechanisms, i.e., wireless, electrical, optical, RFID, IR, and the like. The accessory can add functionality to the probe, such as fiber optic shape sensing, obtaining electrical signals, obtaining bio-impedance measurements, tracking a needle, and determining the orientation of the probe. The accessory may include a needle guide, a triphalangeal support structure, or an acoustically transparent cap.

Abstract: A tissue-cutting dilator can include an elongate dilator body, a dilator tip, a plurality of retractable blades, and a cap. The dilator body can include a plurality of longitudinal guide slots along a distal portion of the dilator body. The dilator tip can be formed in the distal portion of the dilator body or coupled to a distal end of the dilator body. The dilator tip can include a plurality of blade slots. The blades can be disposed in the dilator body. The blades can be configured to extend through the blade slots in a ready-to-dilate state of the dilator to cut tissue around an insertion site upon insertion into the insertion site. The cap can be slidably disposed over the dilator body. The cap can cover the dilator tip in at least the ready-to-dilate state of the dilator.

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: Disclosed herein are integrated catheter-placement devices and methods thereof. An exemplary device includes an intravascular catheter, a needle, an access guidewire, and a blood egress-mitigating means for mitigating blood egress from the device. The intravascular catheter includes a catheter tube and catheter hub. The catheter extends from a body of the device. The needle includes a needle shaft and a needle hub. The needle shaft extends through the catheter tube by way of a catheter-tube lumen thereof. The access guidewire is disposed in a needle lumen of the needle. The blood egress-mitigating means mitigates blood egress from the device by mitigating blood egress from an annular space within the needle shaft while still allowing the access guidewire to axially move within the needle lumen. The annular space is defined by a luminal surface of the needle shaft and a surface of the access guidewire.

Abstract: A shape-sensing system can include an optical-fiber probe and a vibration-assisted torsion-management means for managing torsion in the optical-fiber probe. The optical-fiber probe can be configured to be removably disposed in an elongate medical device. The optical-fiber probe can include an inner construction and an outer construction over the inner construction but detached therefrom over a majority of the optical-fiber probe. The inner construction can include one or more optical-fiber cores disposed in a cladding. The outer construction can include a mechanical layer. The vibration-assisted torsion-management means can be operably coupled to the optical-fiber probe for vibrating either the inner construction or the outer construction of the optical-fiber probe relative to the other, which mitigates or eliminates any optical signal-distorting torsion in the inner construction of the optical-fiber probe.

Abstract: A magnetic signature imprinting system includes an imprinting device and a medical device including ferrous elements. The imprinting device can include an active area having a magnet moving system, one or more sensors, and a console. The magnet moving system can be configured to change the location or orientation of one or more magnets to generate one or more magnetic fields to imprint a magnetic signature. The one or more sensors are configured to detect one or more characteristics of the medical device, and the console can be in communication with the magnet moving system and the one or more sensors.

Abstract: Medical device systems including an elongate medical device having a proximal end including one or more sensor connectors, a distal end including one or more sensors or emitters communicatively coupled to the one or more sensor connectors, and a quick-release drive connector including one or more sensor connector attachments configured to detachably couple to the one or more sensor connectors. The one or more sensor connector attachments can be configured to drive the one or more sensors or emitters of the elongate medical device.

Abstract: Blood vessel recognition and needle guidance systems, components, and methods thereof. A console can be configured to initiate a target recognition process for recognizing an anatomical target, such as a blood vessel, of a patient and a needle guidance process for guiding insertion of a needle into the anatomical target using ultrasound-imaging data received by the console. The system can perform target identification based on machine learning models which can be trained to recognize targets based on the ultrasound image. The ultrasound probe can be configured to provide to the console electrical signals corresponding to the ultrasound-imaging data. The ultrasound probe can include an array of transducers and, optionally, an array of magnetic sensors respectively configured to convert reflected ultrasound signals from the patient and magnetic signals from the needle, when magnetized, into the electrical signals.

Abstract: An elongate multi-core optical fiber instrument for insertion within a patient body includes a set of first optical fiber cores extending along a first sensing region of the multi-core optical fiber instrument, where each first optical fiber core includes a set of first sensors disposed along the first region and a set of second optical fiber cores extending along a second sensing region of the multi-core optical fiber instrument, where each second optical fiber core includes a set of second sensors disposed along the second sensing region. The first sensing region is located distal the second sensing region, and the first optical fiber cores extend along the second sensing region. Also disclosed is a console for providing an incident light signal to the multi-core optical fiber instrument, receiving reflected light signals from the sensors, and determining a parameter experienced by instrument in accordance with the reflected light signals.

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: A medical device-placing system including a medical-device tip-location sensor (“TLS”) configured for placement on a chest of a patient, an ultrasound probe, a console, and an alternative-reality headset. The ultrasound probe can be configured to emit ultrasound signals into the patient and receive echoed ultrasound signals from the patient. The console can be configured to transform the echoed ultrasound signals to produce ultrasound-image segments corresponding to anatomical structures of the patient, as well as transform TLS signals from the TLS into location information for a medical device within the patient. The alternative-reality headset can include a display screen through which a wearer of the alternative-reality headset can see the patient. The display screen can be configured to display over the patient a virtual medical per the location information for the medical device within objects of virtual anatomy corresponding to the ultrasound-image segments.