Abstract: Disclosed are systems and methods for ultrasound-and-bioimpedance-based guidance of medical devices. A system can include an ultrasound probe, a needle, a console, and a display screen. The ultrasound probe is configured to emit ultrasound pulses and receive reflected ultrasound pulses reflected back through one or more tissues for producing ultrasound images. The needle can be configured to emit, detect, or alternately emit and detect electrical currents passed through the one-or-more tissues disposed between a pair or more of system electrodes for measuring bioimpedance. The console can be configured to instantiate one or more console processes for the ultrasound-and-bioimpedance-based guidance with the ultrasound probe and the needle.

Abstract: Disclosed herein are RFID enabled medical device systems including an RFID emitter configured to provide an interrogation signal that impinges on an RFID tag associated with a medical device to trigger a response signal. The response signal can indicate and presence or absence of the medical device proximate to the RFID emitter. A console communicatively coupled to the RFID emitter can determine, record, and analyze procedural or usage information about the medical device. Further information about the medical device can be encoded within the response signal and provided to the console. Console settings can be automatically updated based on the information within the response signal. Additional modalities are also contemplated including optical image recognition of medical device kits. Further AR viewers can provide image overlays to guide a user in correct procedure. Procedural compliance can be automatically recorded and monitored.

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: 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 placement system for tracking, placing, and monitoring a catheter assembly or other medical device inserted into a body of a patient is disclosed. The placement system utilizes optical fiber-based strain sensors to assist with catheter placement. In one embodiment, the placement system comprises a console including a processor and a plurality of optical fiber-based strain sensors included with the catheter. A light source is also included and configured to operably connect with the strain sensors and produce outgoing optical signals incident on the strain sensors. A photodetector is included and configured to operably connect with the strain sensors and receive return optical signals from the strain sensors. A processor is configured to process data from the return optical signals. The data relates to an aspect of the catheter. A user interface such as a display is configured to communicate information relating to the aspect of the catheter.

Abstract: A vascular access device (VAD) monitoring system includes a VAD with a catheter tube that is subcutaneously disposed and incorporates a fluorescent dye. An optical imaging system is also provided, comprising a light source emitting infrared (IR) excitation light and a camera capable of detecting signal light emitted by the fluorescent dye upon exposure to the excitation light. This enables real-time monitoring of the VAD, allowing for the detection of any potential complications or issues related to the vascular access device. The combination of the catheter tube with the fluorescent dye and the optical imaging system provides a non-invasive and efficient means of monitoring the VAD, enhancing patient safety and improving overall healthcare outcomes.

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: A shape-sensing system can include a stylet, an optical interrogator, a console, and a display screen. The stylet can include an optical fiber with fiber Bragg grating (“FBG”) sensors along a length of the optical fiber. The optical interrogator can be configured to send input optical signals into the optical fiber and receive FBG sensor-reflected optical signals from the optical fiber. 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 as the stylet is advanced into a superior vena cava of a patient.

Abstract: A vasculature assessment device includes an imaging probe configured to acquire raw image data of a blood vessel of a patient and a device module having a console coupled with the imaging probe. Logic stored in memory device module determines blood vessel data from the raw image data and applies a trained machine learning model to the blood vessel data to determine suggested catheter parameters for catheter to be inserted within the blood vessel. A vasculature assessment system includes a plurality of the vasculature assessment devices and a computing system coupled with the vasculature assessment devices. Machine learning logic of the computing system performs a machine learning algorithm on historical catheter placement data sets to define the trained machine learning model.

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: A system and method for determining a difficult venous access of a patient. Logic processes meta data acquired by a vasculature assessment device coupled with the patient. The meta data, e.g., vessel diameter, vessel depth, vessel wall thickness, vessel wall elasticity, tissue elasticity, tissue profusion, blood flow rate, or hydration level. The logic further determines a difficult venous access by performing an algorithm on the meta data. The algorithm is defined utilizing machine learning techniques applied to an ongoing collection data sets acquired from a plurality of systems across a plurality of patients undergoing catheter insertion events. The data set may also include patient data such as weight, age, etc. The vasculature assessment device may include ultrasound imaging, infrared imaging, molecular imaging, Raman spectroscopy, or optical coherence tomography to acquire one or both of three-dimensional imaging data and the meta data.

Abstract: A system, apparatus and method directed to placing a medical instrument in a vasculature of a patient body, the system including an optical fiber with one or more core fibers. The system can include 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, wherein the reflected light signal is reflected from at least one of red blood cells or tissue within the patient body, processing the reflected light signal to determine an oxygen level within the patient body near a distal tip of the optical fiber. The method can include determining a location of the distal tip of the optical fiber within the patient body at least based on the oxygen level.

Abstract: Imaging systems and methods for integrated vascular access device indwell assessment and data integration are provided. Such imaging systems and methods can be used to better assess and monitor the status of an indwelling integrated vascular access device and the overall viability of the vascular access in the acute care and alternate site setting and to reduce the patient complications and experience, clinician burden, and overall effectiveness of the patient's treatment and care. Such imaging systems and methods can also facilitate the use of imaging devices, such as ultrasound devices, to assess the current state of an indwelling vascular access device and compare it to a prior state or established clinical standard. This may facilitate predictive detection, identification, and/or diagnosis of an emerging risk of a catheter related complication or detection of an actual complication intermittently and consistently.

Abstract: A placement system for tracking, placing, and monitoring a catheter assembly or other medical device inserted into a body of a patient is disclosed. The placement system utilizes optical fiber-based strain sensors to assist with catheter placement. In one embodiment, the placement system comprises a console including a processor and a plurality of optical fiber-based strain sensors included with the catheter. A light source is also included and configured to operably connect with the strain sensors and produce outgoing optical signals incident on the strain sensors. A photodetector is included and configured to operably connect with the strain sensors and receive return optical signals from the strain sensors. A processor is configured to process data from the return optical signals. The data relates to an aspect of the catheter. A user interface such as a display is configured to communicate information relating to the aspect of the 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, apparatus and method directed to detecting damage to an optical fiber. 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 can include 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: Optical-fiber connector modules are disclosed. In one example, an optical-fiber connector module can include a receptacle, a cable, 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 can extend 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.

Abstract: Disclosed herein is a system, apparatus and method directed to placing a medical instrument in a vasculature of a patient body, including an optical fiber with one or more core fibers. The system can include 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, wherein the reflected light signal is reflected from at least one of red blood cells or tissue within the patient body, processing the reflected light signal to determine an oxygen level within the patient body near a distal tip of the optical fiber. The method may further include determining a location of the distal tip of the optical fiber within the patient body at least based on the oxygen level.

Abstract: A system, apparatus and method directed to detecting damage to an optical fiber. 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 can include 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: 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.