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 are also disclosed.

Abstract: A system, apparatus and method directed to placing a medical device into a body of a patient, including performing 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, and 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: 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: 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: 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: 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: 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: An integrated catheter placement system for placing a catheter in a vasculature of a patient. The system includes a system console with a tip location mode and an ultrasound mode viewable on a display, a magnetic assembly emanating a magnetic field, a tip location sensor designed to sense the magnetic field, and an ultrasound probe for ultrasonically imaging an internal portion of the patient. The magnetic field may provide magnetic field information for locating the magnetic assembly relative to the tip location sensor. The tip location sensor is designed to communicate the magnetic field information to the system console. The system console is designed to display an icon representative of a location of the magnetic assembly relative to the tip location sensor in the tip location mode.

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: 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: Disclosed herein are system and methods for monitoring a medical process. The system can include a plurality of electrodes coupled with a medical device, and a monitoring module electrically coupled with the plurality of electrodes, the module including logic stored in memory that, when executed by one or more processors, causes performance of operations including transmitting an electrical signal between a first electrode and a second electrode, determining an electrical impedance between the first electrode and the second electrode, and providing a notification to the operator when the determined electrical impedance is outside a predefined impedance range. The system can include logic stored in memory that, when executed by one or more processors, causes performance of operations including transmitting an electrical signal between a first distal electrode and a second proximal electrode and determining an electrical impedance between the electrodes.

Abstract: Disclosed herein is an ultrasound imaging system configured to guide medical device insertion. The ultrasound imaging system includes an ultrasound probe having an ultrasound generation device configured to detect one or more anatomical targets within a target area, and one or more projectors configured to project one or more icons within the target area. The ultrasound imaging system can also include a console configured to generate the one or more icons. The console can be coupled to the ultrasound probe, and be in communication with each of the ultrasound generation device and the one or more projectors.

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: Disclosed herein is a system and method directed to detecting placement of a medical device within a patient body, where the system includes a medical device including an optical fiber having core fibers, each of the one or more core fibers including a plurality of sensors each configured to (i) reflect a light signal having an altered characteristic due to strain experienced by the optical fiber. The system further includes logic configured to cause operations of providing an incident light signal to the optical fiber, receiving reflected light signals of different spectral widths of the incident light from the 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 based on the detected fluctuations. In some instances, the detected fluctuations are caused by anatomical movement of the patient body.

Abstract: A system for disinfecting a medical device is disclosed that includes an elongate instrument comprising a plurality of optical fibers extending along a length of the instrument to a disinfection zone, and a light source coupled with the instrument configured to propagate light distally along the optical fibers. The elongate instrument can be configured to redirect the light radially outward from the instrument. An elongate instrument for disinfecting a medical device can include a plurality of optical fibers extending along a length of the instrument from a proximal end to a disinfection zone at a distal end, the optical fibers configured to propagate a light along the instrument. One or more reflective surfaces can be located within the disinfection zone, and the reflective surfaces can be configured to direct the light radially outward from the instrument.

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: Systems and methods for assisting the placement of a catheter within the body of a patient through the use of an ultrasound imaging system are disclosed. In particular, the systems and methods described herein enable a clinician to determine, prior to insertion of the medical device, how much of the device will be disposed within the vessel, thus enabling the clinician to choose a catheter with suitable length. In one embodiment, an ultrasound imaging system for assisting with placement of the medical device comprises a console, a probe for producing an image of a target location, and a processor. The processor provides to a user proximity information relating to the anticipated proximity of the medical device to the target location prior to insertion of the medical device. A display is included for depicting the image, target location depth, and the proximity information of the medical device to the target location.

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 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: 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.