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: Disclosed herein is a system, apparatus and method directed to detecting damage to an optical fiber of a medical device. The optical fiber includes core fibers including a plurality of sensors configured to (i) reflect a light signal based on received incident light, and (ii) change a characteristic of the reflected light signal based on experienced strain. The system also includes a console having memory storing logic that, when executed, causes operations of providing receiving reflected light signals of different spectral widths of the broadband incident light by one or more of the plurality of sensors, processing the reflected light signals to detect fluctuations of a portion of the optical fiber, and determining a location of the portion of the optical fiber or a defect affecting a vessel in which the portion is disposed based on the detected fluctuations. The portion may be a distal tip of the optical fiber.

Abstract: Disclosed herein is a system, apparatus and method directed to placing a medical device into a body of a patient, each performing or including operations of providing a broadband incident light signal to a plurality of core fibers of a multi-core optical fiber, receiving reflected light signals of different spectral width, processing the reflected light signals associated with the plurality of core fibers to determine (i) a physical state of the multi-core optical fiber relating to the medical device including the multi-core optical fiber, and (ii) an orientation of the multi-core optical fiber relative to a reference frame of the body. Additional operations include generating a display illustrating the physical state of the multi-core optical fiber based at least on the orientation determined during processing of the reflected light. Typically, the display is a two-dimensional representation of the multi-core optical fiber in accordance with the determined orientation.

Abstract: A method of positioning a catheter in a blood vessel. The method includes ultrasonically imaging the blood vessel using an ultrasound probe to generate an ultrasound image, communicating the ultrasound image to a console, and displaying the ultrasound image on the console. The method further includes coupling a stylet to the catheter, the stylet including a stylet control module including a timer circuit, and a coil assembly connected to the stylet control module. The method further includes introducing and advancing the catheter and the coil assembly in the blood vessel, sending an electric pulse signal from the timer circuit to the coil assembly at a pulse signal frequency, emitting an electromagnetic field from the coil assembly, and detecting the electromagnetic field by an external sensor. The method may further include synchronizing the pulse signal frequency, and determining a position of the coil assembly with respect to the external sensor.

Abstract: A system for tracking the position of one or more medical devices for insertion into the body of a patient is disclosed. The system may also be used to locate one or medical devices at a later time after placement thereof. The present system employs multiple radiating elements that can be simultaneously detected by a sensor unit of the system, wherein at least one of the radiating elements is included with the medical device. Another of the radiating elements may be placed at a predetermined point on the skin of the patient to serve as a landmark to help determine the location of the medical device with respect to the landmark. Detection of the radiating elements by the sensor unit enables the relative positions of the radiating elements to be ascertained and depicted on a display, to assist a clinician in accurately positioning the medical device, such as a catheter.

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: A system for tracking the position of one or more medical devices for insertion into the body of a patient is disclosed. The system may also be used to locate one or medical devices at a later time after placement thereof. The present system employs multiple radiating elements that can be simultaneously detected by a sensor unit of the system, wherein at least one of the radiating elements is included with the medical device. Another of the radiating elements may be placed at a predetermined point on the skin of the patient to serve as a landmark to help determine the location of the medical device with respect to the landmark. Detection of the radiating elements by the sensor unit enables the relative positions of the radiating elements to be ascertained and depicted on a display, to assist a clinician in accurately positioning the medical device, such as a catheter.

Abstract: Disclosed herein is a needle shield for an ultrasound probe. The needle shield fits closely with an ultrasound probe head, and any associated structures, and prevents accidental damage from needle punctures and the like. Further the needle shield includes a guide wedge that allows a user to stabilize the probe at an angle relative to the skin surface. This allows perpendicular needle access to the target vessel without the probe obstructing the needle. Further the needle shield includes an acoustic lens to modify the acoustic beam and compensate for the angle position of the probe head.

Abstract: A catheter placement system for positioning a catheter in a vasculature of a patient using at least two different modalities. The catheter placement system includes a console with a display, a stylet removably positionable within a lumen of the catheter, a tip location sensor, and an external electrode. The stylet may include an electrocardiogram (ECG) sensor assembly for detecting ECG signals of a node of a heart of the patient, and a first connector in communication with the ECG sensor assembly. The tip location sensor may be configured to detect the stylet when the catheter is disposed within the vasculature of the patient, and to communicate information of the stylet to the console. The console may be configured to receive at least one aspect of the ECG signal detected by the ECG sensor assembly indicative of proximity of the ECG sensor assembly to the node.

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 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 in the distal-end portion of the optical-fiber stylet 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: Optical-fiber connector modules are disclosed. In one example, an optical-fiber connector module can include a receptacle disposed in a housing, a cable extending from the housing, and an optical fiber within at least the cable. The receptacle can be configured to accept insertion of a first plug for establishing a first optical connection between the optical-fiber connector module and an optical-fiber stylet of a medical device. The cable can include a second plug for establishing a second optical connection between the optical-fiber connector module and an optical interrogator. The optical fiber extends from the receptacle through the cable to the second plug. The optical fiber can be configured to convey input optical signals from the optical interrogator to the optical-fiber stylet and reflected optical signals from the optical-fiber stylet to the optical interrogator. Shape-sensing systems including the optical-fiber connector modules and methods of the foregoing are also disclosed.

Abstract: A microintroducer system including an introducer sheath coupled to a handle, the handle and introducer sheath defining a channel therethrough, and an adapter. The adapter includes a receiver tube having a predetermined angled portion, the receiving tube providing a pathway from a proximal opening to the channel of the microintroducer. The adapter can be integral with the microintroducer or separately attached. A separately attached adapter can include a spin nut or other attachment mechanism to couple the adapter to the microintroducer. The predetermined angled portion can include a plurality of curved portions to form, for example, a helical pathway. The microintroducer system can include a shape sensing stylet system. The predetermined angled portion of the adapter can provide a fiduciary point for calibrating the shape sensing stylet. As the stylet passes through the predetermined angled portion, an external device coupled to the stylet calibrates the deflection.

Abstract: Disclosed herein are puncturing devices and puncturing systems including the puncturing devices. Such puncturing devices and systems include those that sense a difference between venous blood and arterial blood as a function of blood oxygen, impedance, or pressure. As a result, the puncturing devices and systems are able to differentiate between a venipuncture and an arterial puncture. Methods of the puncturing devices and systems for differentiating between a venipuncture and an arterial puncture for are also disclosed.

Abstract: An ultrasound imaging device including the ability to determine when a component, such as a removable probe cap, is attached to a portion of an ultrasound probe. Such a cap is employed in one embodiment to act as a spacer component to provide a standoff for the probe head. Detection of probe cap attachment to the ultrasound probe enables the resultant ultrasound image to be adjusted automatically by the ultrasound imaging system. In one embodiment, an ultrasound imaging system comprises an ultrasound probe, a cap or other component that is attachable to the probe, and a component attachment detection system for detecting attachment of the component to the probe. Once the cap is detected, an aspect of an ultrasound image produced by the imaging system is modified, such as cropping the image to remove undesired portions of the cap, such as the spacer component.

Abstract: A disinfection system for use in cleansing one or more medical devices or components that are placed on, in, or in proximity to a patient during a medical procedure is disclosed. Non-limiting examples of a medical component that may be cleansed by the disinfection system include an ultrasound probe or a chest sensor of a catheter placement system. In one embodiment, therefore, a disinfection system for a medical device is disclosed, comprising a container configured for proximate placement with respect to the medical device and an array of light sources included with the container. Each light source is configured to produce disinfecting light in a high energy visible light wavelength range. Further, the light sources are arranged to impinge the disinfecting light upon a portion of the medical device so as to disinfect the impinged surfaces of the medical device.

Abstract: A catheter placement system includes a catheter assembly, an external ultrasound probe, a tip location sensor, and a console. The catheter assembly includes a catheter, a magnetic component producing a magnetic field, and an electrocardiogram (ECG) sensor designed to measure an intravascular ECG signal. The external ultrasound probe includes user input controls. The tip location sensor is configured to detect the magnetic field of the magnetic component when the catheter is disposed in the patient, the magnetic field providing magnetic field information for locating the magnetic component relative to the tip location sensor, and to receive the intravascular ECG signal from the ECG sensor. The console is coupled to the tip location sensor and includes a processor and a display. The display is configured to show an image from the external ultrasound probe, a graphical representation of the magnetic component, and successive ECG waveforms detected by the ECG sensor.

Abstract: A guidance system for assisting with the insertion of a needle or other medical component into the body of a patient is disclosed. The guidance system utilizes ultrasound imaging or other suitable imaging technology. In one embodiment, the guidance system comprises an imaging device including a probe for producing an image of an internal body portion target, such as a vessel. One or more sensors are included with the probe. The sensors sense a detectable characteristic related to the needle, such as a magnetic field of a magnet included with the needle. The system includes a processor that uses data relating to the detectable characteristic sensed by the sensors to determine a position and/or orientation of the needle in three spatial dimensions. The system includes a display for depicting the position and/or orientation of the needle together with the image of the target.

Abstract: A method of positioning a catheter in a blood vessel. The method includes ultrasonically imaging the blood vessel using an ultrasound probe to generate an ultrasound image, communicating the ultrasound image to a console, and displaying the ultrasound image on the console. The method further includes coupling a stylet to the catheter, the stylet including a stylet control module including a timer circuit, and a coil assembly connected to the stylet control module. The method further includes introducing and advancing the catheter and the coil assembly in the blood vessel, sending an electric pulse signal from the timer circuit to the coil assembly at a pulse signal frequency, emitting an electromagnetic field from the coil assembly, and detecting the electromagnetic field by an external sensor. The method may further include synchronizing the pulse signal frequency, and determining a position of the coil assembly with respect to the external sensor.

Abstract: An integrated catheter placement system for accurately placing a catheter within a patient's vasculature is disclosed. In one embodiment, the integrated system comprises a system console, a tip location sensor for temporary placement on the patient's chest, and an ultrasound probe. The tip location sensor senses a magnetic field of a stylet disposed in a lumen of the catheter when the catheter is disposed in the vasculature. The ultrasound probe ultrasonically images a portion of the vasculature prior to intravascular introduction of the catheter. The ultrasound probe includes user input controls for controlling use of the ultrasound probe in an ultrasound mode and use of the tip location sensor in a tip location mode. In another embodiment, ECG signal-based catheter tip guidance is included in the integrated system to enable guidance of the catheter tip to a desired position with respect to a node of the patient's heart.

Abstract: A positioning system includes a console, an ultrasound probe, a stylet, a stylet control module, and an external sensor. The console includes a display. The ultrasound probe is designed to communicate imaging information to the console. The stylet includes a radiating element capable of producing an electromagnetic field, the electromagnetic field providing electromagnetic field information. The stylet control module includes a timer circuit designed to send electrical pulses at a pulse signal frequency to the radiating element. The external sensor is designed to detect the electromagnetic field and to determine a position of the radiating element with respect to the external sensor as the stylet is advanced in a vasculature of a patient, the external sensor designed to communicate the electromagnetic field information to the console. The system may include a circuit configured to synchronize at least one of the console and the external sensor with the pulse signal frequency.