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: 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 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 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.

Abstract: Apparatus and methods of manufacture for an intraosseous assembly. The intraosseous assembly includes a flexible obturator with relatively low columnar strength, relatively low shear strength, and/or relatively high compressive strength. When the flexible obturator is supported in a needle of the intraosseous assembly, it can prevent bone fragments and tissue from blocking the needle lumen. When removed from the needle, the flexible obturator can deform under a force to prevent accidental needle stick injuries. The flexible obturator can define a radially symmetrical profile and can conform to the inner profile of the needle lumen. The flexible obturator can extend beyond a distal tip of the needle and be trimmed flush to a beveled surface of the needle. This simplifies the manufacturing process, allowing a single size obturator to be fitted to multiple sizes of 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: Tissue-cutting devices and methods thereof, where a tissue-cutting device is coupleable with a catheter. The tissue-cutting device includes a blade that cuts the skin during insertion of the device in a needle track to enlarge to needle tract. The tissue-cutting device is configured for lateral separation from the catheter and/or a guidewire. The tissue-cutting device includes a channel for receiving the catheter and/or a guidewire. The channel can be configured to (i) retain the catheter/guidewire within the channel in the absence of a deliberate action by the clinician and (ii) facilitate lateral removal of the catheter/guidewire from the channel in response to the deliberate action. A catheter assembly includes a catheter coupled with the tissue-cutting device. The tissue-cutting device may include a sheath extending along a distal portion of the tissue-cutting device.

Abstract: Devices, systems, and methods for minimizing or preventing contamination of sterile medical devices during magnetization. A magnetizer cover can be used to maintain sterility of a medical device while magnetizing the medical device. The magnetizer cover can include a base and a protective portion. The magnetizer cover can also include a grip tab extending from the base. The protective portion can include a funnel and a funnel stem to protect a magnetizable portion of the medical device from contacting the magnetizer.

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: A magnetic-based tracking system for tracking an ultrasound probe. The tracking system can create a three-dimensional visualization. The tracking system can include a reference device including a reference magnet and an ultrasound probe including an ultrasound acoustic transducer or acoustic array that acquires ultrasound images. The reference device can include a magnetometer that detects a magnetic field generated by the reference magnet. The ultrasound probe can couple a first ultrasound image with a first magnetic field strength, wherein both of the first ultrasound image is received and the first magnetic field strength is detected at a first time.

Abstract: A needle-guidance system is disclosed including single-patient equipment, multi-patient equipment, and an RFID reader-writer. The single-patient equipment can include a vascular access device (“VAD”) having a needle and an RFID tag. The RFID tag can be incorporated into the VAD or packaging for the VAD. The console can be configured to automatically start needle tracking for a clinician on an integrated display screen of the console after receiving RFID-tag data from the RFID tag and processing with a processor of the console instructions of needle-tracking software provided by memory of the console for the needle tracking. The RFID reader-writer can be configured to read the RFID-tag data from the RFID tag and write additional RFID-tag data to the RFID tag. The RFID reader-writer can be provided with the packaging for the VAD or the multi-patient equipment. A method of the needle-guidance system is also disclosed.