Abstract: Disclosed are systems and methods for automatic determination of one or more medical devices for vascular access prior to direct patient assessment. For example, a system can include a console and a display screen optionally integrated into the console. The console can include one or more processors and memory. The memory can include instructions configured to instantiate one or more processes when executed by the one-or-more processors for the automatic determination of the one-or-more medical devices for vascular access in accordance with a plurality of data inputs, various operating parameters, historical data, or a combination thereof. The automatic determination of the one-or-more medical devices can use at least logic, algorithms, machine learning including a machine-learning model trained with the historical data, artificial intelligence, or a combination thereof. The display screen can be configured to display the one-or-more medical devices recommended for vascular access.

Abstract: Disclosed herein are fiber-optic assemblies for insertion within a patient body, that include an optical fiber and a secondary mechanical layer extending around a circumference of the optical fiber along at least the distal portion of the optical fiber. A distal tip section of the optical fiber includes a portion of the optical fiber disposed within a circuitous path, or an expansion of the optical fiber. The optical fiber may be a shape sensing optical fiber. A medical device assembly includes the fiber-optic assembly coupled with a catheter, a stylet, a probe, or a guidewire. The secondary mechanical layer and/or the expansion may be formed of an electrically conductive material.

Abstract: Disclosed herein are medical systems, devices, and methods for identifying a blood vessel as a vein or as an artery. The system includes an optical fiber configured for insertion into a blood vessel coupled with a console having a light source, an optical receiver, processors, and logic stored in memory. The optical fiber includes sensors disposed along its length configured to determine a state or condition of the optical fiber, where the state or condition includes a strain, movement, pressure, or temperature. The logic analyzes reflected optical signals emanating from the sensors to determine that the optical fiber is inserted within an artery or within a vein. Logic may also determine a red-blue shift of a projected light to determine a blood flow direction with respect to the optical fiber.

Abstract: An optical tip-tracking system is disclosed including a light-emitting stylet, a light detector, and a console configured to operably connect to the light-emitting stylet and the light detector. The light-emitting stylet is configured to be disposed in a lumen of a catheter. The light-emitting stylet includes a light source in a distal-end portion of the light-emitting stylet configured to emit light. The light detector is configured to be placed over a patient. The light detector includes a plurality of photodetectors configured to detect the light emitted from the light source. The console is configured to instantiate an optical tip-tracking process for optically tracking the distal-end portion of the light-emitting stylet while the light-emitting stylet is disposed in a vasculature of the patient, the light source is emitting light, the light detector is disposed over the light-emitting stylet, and the photodetectors are detecting the light emitted from the light source.

Abstract: Disclosed are systems and methods for automatically recommending medical devices for 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 the automatic recommending of the medical device for vascular access. The automatic recommending of the medical device for vascular access can be in accordance with a plurality of data inputs, various operating parameters, 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. The display screen can also be configured to display the medical device recommended for vascular access of the one-or-more blood vessels in the ultrasound image.

Abstract: A medical ultrasound system that includes an ultrasound probe and one of number of optional accessories attached to the ultrasound probe. The accessory exchanges data with the probe and receives power from the probe. The accessory includes processors and logic that governs it operation thereby adding functionality to the probe. The accessory receives input and provides output via any of a number of communication mechanisms, i.e., wireless, electrical, optical, RFID, IR, and the like. The accessory adds 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 medical device guide system that includes an ultrasound probe is configured for imaging portions of a patient's body. The system is configured to automatically position and/or orient a needle guide with respect to the probe in accordance with a desired needle trajectory with respect to the target blood vessel. The system includes one or more of a blood vessel detection system, a probe orientation system and/or a needle tracking system to facilitate automatically positioning of the needle guide. Some needle guides include multiple channels that define different angles of needle insertion. The needle guide is selectively coupled with a needle guide connector that is operatively coupled with the probe via an electro-mechanical mechanism.

Abstract: Systems, medical devices, and methods for steering the medical devices are disclosed. For example, a system can include an elongate medical device and a pump station. The medical device can include a tubular body with a lumen. The lumen, which terminates proximal of a distal end of the medical device, can be configured to contain a fluid. The pump station can be configured to pressurize the fluid and, thereby, induce a curve in at least a distal portion of the medical device for steering the medical device through one or more anatomical lumens. Being as the tubular body of the medical device (e.g., a stylet) is configured to be disposed in another lumen of another elongate medical device (e.g., a catheter), any curvature in the medical device can be imparted to the other medical device when disposed therein for steering the other medical device through the one-or-more anatomical lumens.

Abstract: Systems, medical devices, and methods for controlling stiffness of the medical devices are disclosed. For example, a system can include an elongate medical device such as a stylet and a pneumatic or hydraulic pump station. The medical device can include a tubular body with a lumen. The lumen, which terminates proximal of a distal end of the medical device, can be configured to contain a fluid. The pump station can be configured to pressurize the fluid and, thereby, stiffen at least a distal portion of the medical device. Being as the tubular body of the medical device is configured to be disposed in another lumen of another elongate medical device such as an intravenous catheter, any stiffness in the medical device (e.g., the stylet) can be imparted to the other medical device (e.g., the catheter) when disposed therein.

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: Embodiments disclosed herein are directed to steerable devices configured to negotiate tortuous vascular pathways. The system can include a stylet having a shapeable portion formed of a shape-memory, super-elastic material such as Nitinol. The stylet can be placed within a catheter and can include a fiber-optic strain sensor (FOSS) system configured to determine a shape of the stylet. Passing a fluid of a predetermined temperature through a lumen of the catheter can modify temperature of the shapeable portion which in turn can modify a shape and/or flexibility state of the shapeable portion. Modifying the shape of the shapeable portion can modify an angle at which a distal tip of the stylet extends relative to the central longitudinal axis. A user can then rotate and advance the distal tip to negotiate tortuous vascular pathways. Similarly, modifying a flexibility of the shapeable portion can facilitate negotiating tortuous vascular pathways.

Abstract: Strain-sensing systems, indwelling medical devices, and methods for determining one or more physical attributes are disclosed. A strain-sensing system can include, for example, an indwelling medical device, an optical interrogator, and a console. The medical device can include an optical-fiber probe having fiber Bragg grating (“FBG”) sensors. The optical interrogator can be configured to send input optical signals into the optical-fiber probe and receive FBG sensor-reflected optical signals therefrom.

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: Disclosed herein are medical systems and devices that include an elongate probe configured for insertion into a patient and/or a catheter. The elongate probe includes an optical fiber and a number of electrical conductors extending along the elongate probe. The probe further includes a tip electrode and a number of band electrodes for obtaining an ECG signal and a bioimpedance, respectively. The optical fiber is configured for shape sensing and to detect strain and fluctuations of the probe. A system includes the probe, and a logic of the system is configured to determine a location of the probe along a vasculature and further determine a location of a catheter with respect to the probe via optical signals and/or electrical signals.

Abstract: Disclosed herein is an ultrasound imaging system having an ultrasound probe, one or more sensors and a feedback system all in communication with a console. The ultrasound probe includes an ultrasound transducer array configured to capture one or more ultrasound images of a target area. The one or more sensors are coupled to the ultrasound probe and to detect and track a magnetic signature of a needle in three-dimensional space within the target area. The feedback system is configured to provide two or more types of feedback to a user, including feedback related to each of identifying and distinguishing the target vessel from the other anatomical targets, tracking the needle along an optimal needle trajectory, or confirming the needle has accessed the target vessel. The console is configured to activate the feedback system, determine the target vessel, and determine an optimal needle trajectory to access the target vessel.

Abstract: Disclosed herein are medical systems and devices that include an elongate probe configured for insertion into a patient, where the elongate probe includes an electrically conductive (EC) medium extending along probe. The EC medium may take several forms, including a conductive cannula, an ionic solution, a flex circuit, wires, or platings. The probe includes a conductive tip for exchanging electrical signals with a patient. The probe includes optical fiber having shape sensing core fibers, illuminating core fibers and imaging core fibers. A console of the system includes logic executed by one or more processors to perform operations that include providing and/or receiving electrical signals to and from the patient. Operations further include shape sensing of the probe, projecting illuminating light, and receiving imaging light.

Abstract: A catheter placement system designed to establish a conductive pathway through a sterile barrier from a sterile field to a non-sterile field. The catheter placement system can include a stylet having a first connector including a piercing component, and a sensing component, and a data-receiving component having a second connector. The data-receiving component can be designed for positioning in the non-sterile field under the sterile barrier. The first connector can be designed to conductively connect to the second connector of the data-receiving component through the sterile barrier via the piercing component without compromising the sterile field.

Abstract: Disclosed herein are medical systems and devices that include an elongate probe configured for insertion into a patient, where a multi-core optical fiber extends along the elongate probe. The optical fiber can include sensing core fibers that extend distally along the probe. The optical fiber can further include illumining core fibers to facilitate projection of light away from the distal end in various illumination patterns. The system includes a console having processors and logic stored in memory. The logic can facilitate singly projecting the illumination light in the various pattens. The logic can also extract an image from returning light and compare wavelengths between the illuminating light and the returning light to determine a motion of body elements.

Abstract: Disclosed herein are medical systems and devices that include an elongate probe configured for insertion into a patient, where the elongate probe includes an atraumatic tip and where the atraumatic tip includes one or more of a loop, a curl, coil, a flexible distal tip section, a steerable distal tip section, a distal tip section configured to transition away from a first shape toward a second shape upon insertion of the elongate probe within the patient. The optical fiber includes sensing core fibers configured to facilitate a determination of a physical state of the elongate probe. The elongate probe is also configured to project illuminating light away from a distal end and receive imaging light at the distal end.

Abstract: An ultrasound imaging system configured to capture a plurality of ultrasound images and determine one or more optimal ultrasound images from the plurality of ultrasound images. The ultrasound imaging system includes an ultrasound probe having an ultrasound array configured to capture a plurality of ultrasound images of a target vessel and other anatomical targets within a target area. The ultrasound imaging system further includes a console in communication with the ultrasound array, the console configured to detect one or more vessel characteristics of the target vessel, determine one or more vessel characteristic values from the one or more vessel characteristics, and compare each vessel characteristic value with one or more vessel characteristic thresholds to determine one or more optimal ultrasound images from the plurality of ultrasound images.