Abstract: Shape-sensing systems and methods for medical devices. The shape-sensing system can include a medical device, an optical interrogator, a console, and a display screen. The medical device can include an integrated optical-fiber stylet having fiber Bragg grating (“FBG”) sensors along at least a distal-end portion thereof. The optical interrogator can be configured to send input optical signals into the optical-fiber stylet and receive FBG sensor-reflected optical signals therefrom. The console can be configured to convert the reflected optical signals with the aid of filtering algorithms of some optical signal-converter algorithms into plottable data for displaying plots thereof on the display screen. The plots can include a plot of curvature vs. time for each FBG sensor of a selection of the FBG sensors for identifying a distinctive change in strain of the optical-fiber stylet as a tip of the medical device is advanced into a superior vena cava of a patient.

Abstract: Devices and methods for an autovance intraosseous device. The autovance intraosseous device can include a trigger activated system or pressure activated system that causes a needle to advance distally for a predetermined distance. The predetermined distance ensures a needle tip extends through the bone cortex, to access the medullary cavity, without penetrating a far wall of the medullary cavity. The advancement can be driven by a spring based system or an electric motor.

Abstract: A catheter assembly includes a peripheral intravenous (“PIV”) portion that provides expedited vascular access. The catheter assembly includes an elongate catheter body defining a first lumen and includes a CVC portion, a transition portion, and a PIV portion. The PIV portion defines a relatively smaller diameter, a tapered tip, and a lumen configured to receive a needle. The needle extends through a needle access aperture, disposed through a side wall of the catheter body, through the PIV lumen, to a point beyond a distal end of the catheter body. A clinician accesses a vasculature using the needle and the PIV portion. The needle is then removed and a guidewire advanced through the lumen of the catheter body and the PIV portion into the vasculature. The CVC portion is then advanced over the guidewire into the vasculature, self-dilating the insertion site as the transition portion enters the vasculature.

Abstract: Disclosed herein is a probe head-cover applicator and method for applying a probe-head cover to a probe head of an ultrasound probe. A probe head-cover applicator can include a tray including a cavity, an insert of a compressible material suspended over the cavity, and a probe-head cover adhered to the insert. The insert can include a first adhesive on an outward-facing surface of the insert facing away from the cavity. The probe-head cover can be adhered to the insert by the first adhesive. The probe-head cover can include a second adhesive on an outward-facing surface of the probe-head cover facing away from the insert. The second adhesive can be configured to adhere the probe-head cover to a probe head of an ultrasound probe when the probe head is inserted into the cavity.

Abstract: Optical connection systems including electrical-and-optical connection systems and methods thereof are disclosed. An electrical-and-optical connection system can include an extension tube having a plug and a relay module having a receptacle. The plug can be formed of a metal piece around electrical wires, which, in turn, are around optical-fiber cores that extend along a length of the extension tube. The plug can be configured to pierce through at least a sterile barrier. The relay module can include electrical wires and optical-fiber cores within a housing of the relay module, as well as a receptacle disposed in the housing. The receptacle can be configured to simultaneously accept insertion of the plug therein and establish both electrical and optical connections between the plug and the receptacle from a sterile field to a non-sterile field set up by the sterile barrier. Shape-sensing systems including the optical connection systems are also disclosed.

Abstract: Embodiments disclosed herein are directed to a securement device including a retainer defining a channel and at least one mounting wing extending therefrom. The mounting wing extends distally of an insertion site a skin surface adjacent to the insertion site to prevent “rocking” or “pistoning.” The mounting wing further includes channels of reduced thickness configured to impart malleable properties on the mounting wing. This can allow the mounting wing to be shaped to fit different portions of the patient. The retainer further includes various locking and anti-rotational features to guide the catheter into position within the retainer and further prevent “rocking” or “pistoning.” The securement device also includes a protective pad to inhibit abrasions from a medical line, spin nuts, and the like, and includes a clasping feature to retain a portion of the release liner to prevent obstructing ingress/egress of the catheter.

Abstract: Devices and methods obtain and use endovascular electrograms (or electrocardiograms/ECGs) in a number of clinical applications and settings. In one embodiment, a method for locating an indwelling medical device within a vasculature of a patient includes identifying a P-wave segment in an endovascular ECG signal associated with the indwelling medical device, then calculating a positive energy value relating to an amount of energy of the P-wave segment above a baseline of the endovascular ECG signal and a negative energy value relating to an amount of energy of the P-wave segment below a baseline of the endovascular ECG signal. A position of the medical device within the vasculature can be determined using at least one of the positive energy value and the negative energy value in a graphical user interface.

Abstract: An ultrasound probe (“probe”) for use with an ultrasound imaging system is disclosed. In particular, the probe is sized and configured so as to be supported and readily used with as little as one finger on a single hand of a user of the imaging system. This configuration enables remaining fingers on the hand of the user to be employed for other purposes, such as skin traction and patient contact. In one embodiment, therefore, an ultrasound probe is disclosed, comprising a body, a lens included on head portion of the body, a stabilizing portion extending from the body and configured to stabilize the body on a skin surface of a patient without user assistance, and a finger grip portion configured to enable a user of the probe to grasp and maneuver the probe during use thereof with no more than two fingers on a single hand of the user.

Abstract: Embodiments of the present invention are directed to guidewire advancement and blood flashback systems. In particular, an insertion tool includes a frangible guidewire lever configured to break and prevent further movement of a guidewire if the guidewire becomes caught. Such a feature can prevent breakage of a distal portion of the guidewire which otherwise could undesirably lead to an embolism. The insertion tool can further include a blood flash indicator that has a simplified coupling with a needle. The insertion tool can further include a guidewire advancement assembly configured to allow a clinician to hold the insertion tool proximate a distal end and operate the guidewire advancement with one hand while providing increased control over the insertion tool. The insertion tool can further include a safety clip coupled with a catheter hub and configured to close about a tip of the needle when a catheter is detached from the insertion tool.

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: Connection systems are disclosed for establishing one or more electrical connections through a drape. An example connection system includes a first connector and a second connector configured to connect to each other. The first connector includes a first-connector housing, an electrical lead extending from the first-connector housing, and at least a first piercing element within the first-connector housing configured to pierce the drape. The first piercing element is orthogonally connected to the electrical lead. The second connector includes a second-connector housing and at least a first receptacle within the second-connector housing. The first receptacle is configured to form at least a first electrical connection of the one or more electrical connections with the first piercing element when the first connector is disposed over the second connector with the drape therebetween. Methods are also disclosed herein for establishing one or more electrical connections through a drape with the connection systems.

Abstract: Devices and systems for navigation and positioning a central venous catheter within a patient. In an exemplary embodiment of a system of the present disclosure, the system comprises a first pole and a second pole, the first pole and the second pole configured to generate an electric field within a mammalian body sufficient to obtain a plurality of field measurements therein, and an elongated body configured for at least partial insertion into a blood vessel of the mammalian body and advancement through a vasculature, said advancement dependent upon the plurality of field measurements indicative of one or more locations of a portion of the elongated body within the vasculature. In at least one embodiment, the elongated body is configured as a stylet.

Abstract: A new apparatus, algorithm, and method are introduced herein to support navigation and placement of an intravascular catheter using the electrical conduction system of the heart (ECSH) and control electrodes placed on the patient's skin.

Abstract: Devices and systems for navigation and positioning a central venous catheter within a patient. In an exemplary embodiment of a system of the present disclosure, the system comprises a first pole and a second pole, the first pole and the second pole configured to generate an electric field within a mammalian body sufficient to obtain a plurality of field measurements therein, and an elongated body configured for at least partial insertion into a blood vessel of the mammalian body and advancement through a vasculature, said advancement dependent upon the plurality of field measurements indicative of one or more locations of a portion of the elongated body within the vasculature. In at least one embodiment, the elongated body is configured as a stylet.

Abstract: Connection systems and methods thereof facilitate establishing electrical connections through a barrier such as a drape without compromising a sterile field established by the barrier. A connection system can include two connectors. A first connector can include a first-connector housing defining a cavity, a slideable end piece coupled to a distal-end portion of the first-connector housing, and at least a first piercing element connected to a first electrical lead. The first piercing element can be configured to enter the cavity and pierce a barrier disposed in the cavity when the slideable end piece is advanced toward a proximal-end portion of the first-connector housing. A second connector can include at least a first receptacle within a second-connector housing connected to a second electrical lead. The first receptacle can be configured to form at least a first electrical connection with the first piercing element after the first piercing element pierces the barrier.

Abstract: A connection system includes a first connector and a second connector configured for establishing one or more electrical connections through a drape. The first connector can include an alignment protrusion and a first piercing element having one or more electrical contacts configured to pierce the drape. The second connector can include an alignment notch, a channel, and a first receptacle configured to receive the first piercing element when inserted therein. The alignment notch can be configured to accept the alignment protrusion when the first connector is aligned with the second connector then disposed over the second connector. The channel can be configured to allow the alignment protrusion to slide along a length of the second connector. The first receptacle can have one or more electrical contacts configured to form at least a first electrical connection of the one or more electrical connections with the first connector.

Abstract: A system for facilitating vascular access is disclosed. The system includes an imaging device including a transducer configured for ultrasound image data acquisition, an ECG signal acquisition device configured to acquire ECG signal data via one or more leads, wherein a first lead is directly connected to skin of a patient, and a mobile application configured to render a graphical user interface to be displayed on a display screen of a mobile device, wherein the graphical user interface illustrates a representation of at least one of the ultrasound image data or the ECG signal data that is wireless transmitted to the mobile device.

Abstract: Devices and methods obtain and use endovascular electrograms in a number of clinical applications and settings. In one embodiment, methods for triggering analysis of an endovascular ECG waveform are based on the detection of a peak in a skin-based ECG waveform in order to determine a location of an indwelling medical device, such as a catheter. In another embodiment, the position of a catheter or other medical device within the vasculature can be determined by analysis of the energy profile of a detected P-wave. In yet other embodiments, magnetic connecting devices are used for establishing an operable connection through a sterile field.

Abstract: Graphical layouts, algorithms, and methods are introduced herein to implement user interfaces for mobile and/or wearable medical devices. In one aspect of the present invention, new graphical layouts are introduced for simplified presentation of time-dependent patient data. In another aspect of the invention, methods and algorithms are introduced to acquire, extract and present relevant features of patient data in real-time in order to simplify the graphical presentation and interpretation. In another aspect of the invention, elements of a multi-modal user interface are introduced in order to simplify and minimize the user's interaction with the medical wearable device. In yet another aspect of the invention, further methods are introduced for real-time interaction between a user or several users and a wearable or several wearable medical devices.