Abstract: Disclosed herein is a system, apparatus and method directed to placing a medical instrument in a patient body, where the system includes the medical instrument having a first optical fiber, a console and an interconnect having a second optical fiber to receive incident light from the console and propagate the incident light to the medical instrument. The interconnect includes a predetermined bend along its length, such that logic of the console may determine a positioning and an orientation of the medical instrument relative to the predetermined bend. Additionally, the logic may generate a display of the medical instrument based on the reflected light signals and the determination of the positioning and the orientation of the medical instrument relative to the predetermined bend, where the display may be rendered as an overlay on an ultrasound image.

Abstract: A medical device operating as a stylet is described. The medical device can include an insulating layer (or sheath) encapsulating both a multi-core optical fiber and a conductive medium. The optical fiber can include a cladding and a plurality of core fibers spatially arranged within the cladding. Each of the core fibers can include a plurality of sensors distributed along a longitudinal length of that corresponding core fiber and each of these sensors can be configured to: (i) reflect a light signal of a different spectral width based on received incident light, and (ii) change a characteristic of the reflected light signal for use in determining a physical state of the multi-core optical fiber. The conductive medium can provide a pathway for electrical signals detected at a distal portion of the conductive medium. The conductive medium may be concentric to the cladding, but separate and adjust thereto.

Abstract: Portable ultrasound systems and methods, the portable ultrasound system can include a handheld computer, a case holding the handheld computer, a probe head coupled to the case, and a communicating means for communicating between the probe head and the handheld computer. The handheld computer can include a display. The case can include an anterior opening framing the display of the handheld computer. The case can include a rechargeable battery integrated into the case opposite the anterior opening. The probe head can include an array of ultrasonic transducers powered by the battery.

Abstract: A magnetizer system for use with a medical device including ferrous elements. The magnetizer can include a magnetizer body defining a cavity, the magnetizer body having a body opening in communication with the cavity, the magnetizer body including one or more magnets configured to generate a magnetic field configured to imprint a magnetic signature on ferrous elements within the cavity. The magnetizer can include one or more mechanisms configured to detect the presence of the medical device.

Abstract: A system for magnetic field direction detection when placing a catheter is disclosed, including a sensor configured to track a medical device, the sensor including a magnetic sensor printed circuit board including a plurality of magnetometers arranged in a magnetometer array. The system can include a console coupled to the sensor, including a processor and non-transitory computer-readable medium having stored a plurality of logic modules that when executed by the processor, are configured to perform operations including receiving detected magnetic field strength values detected by the plurality of magnetometers, determining a position on the sensor of each of the plurality of magnetometers, determining the magnetic field source direction based on the detected magnetic field strength values and the position on the sensor of each of the plurality of magnetometers, and displaying the magnetic field source direction on the display.

Abstract: A safety mechanism is disclosed configured for shielding a distal tip of an elongate medical device. The safety mechanism includes a sheath having a body defining a lumen extending axially and including a shroud extending axially and having one or more sheath apertures disposed therethrough. The safety mechanism further includes a clip, comprising one or more arms, each including a tab, a plate, and a grip, the tab including a keyhole aperture. The first arm and the second arm configured to transition between a first configuration and a second configuration, and an elongate biasing member extending from the first arm to the second arm and configured to bias the first arm and the second arm towards the second configuration. Transitioning from the first configuration to the second configuration disengages the sheath from a needle hub and engages the sheath with a tip of the elongate medical device.

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 metal 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: Disclosed herein are medical-device magnetizer systems and methods. In an example, a magnetizer system can be configured to impart one or more magnetic signatures to a medical device having ferrous elements for medical-device tracking. Such a magnetizer system can include, in some embodiments, a magnetizer. The magnetizer can have an elongate body with a single-dipole section, a multipole section, and a plurality of magnets configured to generate two or more magnetic fields. The single-dipole section can have a magnetizer body defining a cavity having a first magnetic field therein. The multipole section can have a second magnetic field therein. In another example, a method can include imparting a magnetic signature to a plurality of medical devices having ferrous elements using the magnetizer system.

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: Disclosed herein is a system, apparatus and method directed to placing a medical instrument in a vasculature of a patient body, where the medical instrument includes an optical fiber having one or more core fibers. The system also includes a console having non-transitory computer-readable medium storing logic that, when executed, causes operations of providing an incident light signal to the optical fiber, receiving a reflected light signal of the incident light, processing the reflected light signals associated with the optical fiber and determining a location of a distal tip of the medical instrument within the patient body. The medical instrument may be steerable in one of various methods including having a predetermined curvature, a distal tip that is magnetic, magnetized, metallic or ferrous and is steerable by an external magnetic device or a having a variable stiffness at a distal tip.

Abstract: Disclosed herein is a magnetic signature imprinting system including an imprinting device and a medical device including ferrous elements. The imprinting device includes an active area having a magnet moving system, one or more sensors, and a console. The magnet moving system is 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 is in communication with the magnet moving system and the one or more sensors.

Abstract: An ultrasound imaging system configured to generate a 3D ultrasound image of a target area is disclosed herein. The ultrasound imaging system includes a console including one or more processors and non-transitory computer readable medium having stored thereon one or more logic modules. The ultrasound imaging system further includes an ultrasound probe, configured to acquire a plurality of ultrasound images of a target area, the ultrasound probe coupled to the console by an ultrasound probe connector having optical fiber including one or more core fibers, the ultrasound probe being a point of reference for the console to generate a three-dimensional visualization by stitching together the plurality of ultrasound images, starting from the point of reference.

Abstract: Blood vessel recognition and needle guidance systems, components, and methods thereof are disclosed. A console can be configured to instantiate 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 artificial intelligence (AI), 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: Disclosed herein is an ultrasound imaging system used to place a catheter within a target vessel. The ultrasound imaging system includes an ultrasound probe having an ultrasound array configured to capture one or more ultrasound images of the target vessel and other anatomical targets within a target area. The ultrasound array is in communication with a console configured to automatically detect the target vessel within the one or more ultrasound images and determine a catheter purchase. The ultrasound imaging system further includes one or more sensors in communication with the console, the one or more sensors configured to detect and track one or more magnetic signatures of an elongate medical device within the target area.

Abstract: A magnetizing system for use in selectively magnetizing a needle of a medical device is disclosed. Once magnetized, the needle can be tracked by a needle guidance system, which assists the clinician placing the needle by visualizing on a display the position and orientation of the needle after its insertion into a body of a patient. An orientation key system is included with the magnetizing system to ensure the needle is positioned correctly in the magnetizing system. This in turn ensures that the needle is properly magnetized so as to be accurately tracked by the needle guidance system. In one embodiment a first key is included with the magnetizing system and configured to cooperatively mate with a second key included with the needle of the medical device. Various types of keys are disclosed herein.

Abstract: A magnetic-based tracking system for tracking an ultrasound probe to create a three-dimensional visualization. The 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 and a magnetometer that detects a magnetic field generated by the reference magnet. The ultrasound probe couples 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. The system can include a console including a processor and non-transitory computer-readable medium having stored thereon a plurality of processor executed logic modules that perform operations including receiving and recording a plurality of coupling of ultrasound images and detected magnetic field strengths, and generating a 3D visualization from the ultrasound images.

Abstract: Push activated intraosseous (IO) access devices include replaceable and rechargeable or non-rechargeable 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: According to one embodiment, a guidance system is described for assisting in an advancement of a medical component within a body of a patient. The guidance system features a probe and a console. The console is communicatively coupled to the probe and features AI-based visualization controls and AI-based guidance assistance logic. The AI-based visualization controls are configured to generate, position, and reposition a visualization area between the medical component and a targeted vasculature of the patient. The visualization area is a sub-region of a total imaging area rendered by the console. The AI-based guidance assistance logic is configured to monitor for a presence of the medical component within the visualization area, provide a feedback for generating a notification that the medical component is within the visualization area, and apply an imaging enhancement to at least a portion of imaged data within the visualization area to assist in the advancement.

Abstract: Guidewire-management devices and systems thereof are disclosed herein. A guidewire-management device can include a guidewire, a first sleeve, and a second sleeve. The first sleeve can be configured for distally feeding the guidewire out of the guidewire-management device. The first sleeve can also be configured for proximally feeding the guidewire into the guidewire-management device. The second sleeve can be proximal of the first sleeve in the guidewire-management device. The second sleeve can be configured for feeding the guidewire in concert with the first sleeve. At least a length of the guidewire extending between the first sleeve and the second sleeve can be disposed within a sterile barrier configured to maintain sterility of the guidewire.

Abstract: Guidewire-management devices and methods thereof are disclosed herein. A guidewire-management device can include a guidewire, a first sleeve, and a second sleeve. The first sleeve can be configured for distally feeding the guidewire out of the guidewire-management device. The first sleeve can also be configured for proximally feeding the guidewire into the guidewire-management device. The second sleeve can be proximal of the first sleeve in the guidewire-management device. The second sleeve can be configured for feeding the guidewire in concert with the first sleeve. At least a length of the guidewire extending between the first sleeve and the second sleeve can be disposed within a sterile barrier configured to maintain sterility of the guidewire. Methods of the guidewire-management devices can include a method of using a guidewire-management device such as the foregoing guidewire-management device.