Abstract: Disclosed are systems and methods for automatically determining needle guides for establishing vascular access. For example, a system can include an ultrasound probe, a console operably coupled to the ultrasound probe, and a display screen integrated into the console. The console can include one or more processors and memory including instructions configured to instantiate one or more processes when executed by the one-or-more processors for automatic determination of a needle guide in accordance with ultrasound-imaging data, historical data, or a combination thereof. The automatic determination of such a needle guide can use logic, algorithms, machine learning, artificial intelligence, or a combination thereof. The display screen can be configured to display an ultrasound image including one or more blood vessels below a skin surface of a patient as well as the needle guide resulting from the automatic determination for establishing vascular access to the one-or-more blood vessels in the ultrasound image.

Abstract: Embodiments disclosed herein are directed to trackable medical device, e.g. a catheter placement system, having a needle formed of a magnetizable material, and magnetized to produce a magnetic field having a magnetic field strength or a magnetic field signature detectable by a sensor of a tracking system. The medical device further includes a spring formed of a non-magnetizable material, e.g. silver coated copper beryllium or the like, and configured to display the same mechanical performance properties as a spring formed of the magnetizable material. Also disclosed is a method of tracking a medical device including magnetizing the catheter placement system to produce a magnetic field having a strength or a magnetic field signature and detecting the magnetic field by a sensor of a tracking system.

Abstract: A catheter placement system that includes a catheter placement device having elongate body configured for insertion into a catheter lumen, where the elongate body includes a body lumen. A compartment at a proximal end of the body is in fluid communication with the body lumen. A saline solution disposed within the compartment and the body lumen defines an electrical path along the elongate body and an electrode at a distal end of the elongate body. A stylet extends along the elongate body, where the stylet includes a multi-core optical fiber extending along the stylet, and where the multi-core optical fiber includes a number of fiber Bragg gratings disposed along the optical fiber to enable shape sensing of the optical fiber. A system module optically and electrically coupled with the catheter placement device displays a shape of the elongate body and ECG waveform.

Abstract: Rapidly insertable central catheters (“RICCs”), RICC insertion assemblies, and methods are disclosed. For example, a RICC insertion assembly can include a RICC, an introducer, and an access guidewire. An introducer needle can include a needle shaft having a longitudinal gap extending from a proximal portion of the needle shaft through a needle tip. An introducer sheath can include a splittable sheath hub coupled to a splittable sheath body. The introducer sheath can be disposed over the introducer needle with the sheath body sealing the needle shaft for drawing a vacuum through the introducer needle. The access guidewire can extend along an entirety of a primary lumen of the RICC, through a splittable valved port of the sheath hub, along a sheath body-covered needle channel of the needle shaft, and to a location in the introducer proximal of the needle tip in a ready-to-operate state of the RICC insertion assembly.

Abstract: Disclosed herein are two-piece catheters and methods thereof. For example, a two-piece catheter can include a proximal catheter piece and a distal catheter piece. The proximal catheter piece includes a proximal catheter-hub piece and one or more extension legs respectively including one or more extension-leg lumens. Each extension leg of the one-or-more extension legs is coupled to the proximal catheter-hub piece by a distal-end portion of the extension leg. The distal catheter piece includes a distal catheter-hub piece and a catheter tube including one or more catheter-tube lumens. The catheter tube is coupled to the distal catheter-hub piece by a proximal-end portion of the catheter tube. The two-piece catheter has a connected state in which the proximal catheter-hub piece is connected to the distal catheter-hub piece such that the one-or-more catheter-tube lumens are respectively fluidly connected to the one-or-more extension-leg lumens across a two-piece catheter hub.

Abstract: Embodiments disclosed herein are directed to a non-uniform, targeted ultrasound image modification system. The system can image a target area using ultrasound and can determine one or more target locations within the target area. Further the system can determine a location and orientation of a medical device to overlay a trajectory onto the target area. A user can further modify the one or more target locations as needed. The user can then modify an image parameter for the target area, and can further modify an image parameter for one or more target locations independently of the target area. This allows a user to modify the image of the target location to suit the position, tissue structure, or a procedure taking place there without affecting the image quality of the rest of the target area, or other target locations.

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: Connection systems and methods for establishing optical and electrical connections through a drape are disclosed. A connection system can include a plug and a receptacle, the plug being configured to insert into the receptacle with the drape therebetween. The plug can include an optical terminal extending from a plug housing and an electrical terminal extending from the plug housing. The electrical terminal can be configured as a piercing element for piercing the drape. The receptacle can include an optical receiver within a receptacle housing and an electrical receiver within the receptacle housing. The optical receiver can be configured to form the optical connection with the optical terminal, and the electrical receiver can be configured to form the electrical connection with the electrical terminal when the plug is inserted into the receptacle with the drape therebetween.

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: Ultrasound probes, ultrasound systems, and ultrasound methods with pressure measurement capabilities for detecting and determining if bodily tissue is over-compressed during ultrasound imaging procedure. An ultrasound probe can include a probe body, an articulating probe head attached to the probe body, and a pressure-sensing device housed in an articulating area between the articulating probe head and the probe body. A method can include placing the articulating probe head of the ultrasound probe on a skin surface of a patient and moving the articulating probe head of the ultrasound probe over the patient while ultrasound signals are emitted into the patient from the articulating probe head. The method can also include monitoring for measured pressure values induced on the patient by the articulating probe head to determine whether a threshold pressure value has been exceeded.

Abstract: Disclosed herein is an ultrasound training system that according to various embodiments includes an ultrasound probe, a vascular access device, and a patient simulation block. Logic of the system tracks the location and orientation of the probe and the vascular access device via magnetic tracking, fiber optic shape sensing, inertia measurement or any combination thereof. The logic depicts the vascular access device in relation to the patient simulation block on a display along with a simulated ultrasound image. The patient simulation block may include artificial anatomical elements and the logic may depict simulated anatomic elements aligned with the artificial anatomical elements. The probe includes a load sensor and the logic depicts an anatomic element having a shape affected by the load. The vascular access device includes magnetic elements defining a magnetic signature and the logic depicts the type and/or size of the vascular access device based on the magnetic signature.

Abstract: Central catheters, central catheter assemblies, and methods thereof. A central catheter includes a catheter tube coupled with a number of extension legs, a needle hub coupled with the catheter tube, where the needle hub is configured to receive a needle therethrough so that the needle is disposed within a primary catheter tube lumen. The central catheter includes a manifold hub for coupling the number of extension legs with the catheter tube. The manifold hub may be integral to the needle hub. The needle hub includes a septum within a needle-hub lumen, where the septum is configured to define a fluid tight seal with the needle and to prevent fluid flow through a proximal portion of the needle-hub lumen when the needle is withdrawn from the needle-hub lumen. A method for introducing a central catheter into a blood vessel.

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.