C. R. Bard, Inc.

Bard Access Systems, Inc.

Inceptio Medical Technologies, Lc

Shayne Messerly

Anthony K Misener

Eddie K Burnside

Steffan Sowards

William Robert McLaughlin

Jeremy B Cox

Kelly J Christian

Matthew W Bown

Chase Thompson

Jason R Stats

Amir Orome

Catherine C Breiter

Christian W Crook

Ryan R Lemon

Jeanette E Southard

Kelly B Powers

Robert N Golden

Jiaye Z Jho

Paul D Morgan

Rodney L Scruggs

Rand William Lee

Jay Allen Muse

Douglas A Christensen

Bret Hamatake

Bradley J Stringer

Benjamin A Cohen

Bruce M Wilcox

Glen E Southard

Tab Robbins

Kevin W Stinger

Cameron P Ford

Gary A Simmons

Robert W Evensen

Dylan K Robles

Robin Scott Urry

Anthony Kent Misener

Christian W Cook

Ben Cohen

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.

Anatomical oscillation and fluctuation sensing and confirmation system

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.

Automatic dimensional frame reference for fiber optic

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.

Probe shield

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.

RFID enabled medical devices and associated systems

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. The display screen is configured to display a graphical representation of the needle among anatomical features of the patient in the ultrasound images confirmed by the bioimpedance of the one-or-more tissues previously or instantly disposed between the pair-or-more of system electrodes.

Systems and methods for ultrasound-and-bioimpedance-based guidance of medical devices

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.

Fiber optic medical systems and methods for identifying blood vessels

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.

Ultrasound system with target and medical instrument awareness

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.

Systemized and method for optimized medical component insertion monitoring and imaging enhancement

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.

Optical fiber-based medical device tracking and monitoring system

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.

Shape-sensing systems with filters and methods thereof

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.

Fiber optics oximetry system for detection and confirmation

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.

Bragg grated fiber optic fluctuation sensing and monitoring system

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.

Optical-fiber connector modules including shape-sensing systems and methods thereof

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.

Shape-sensing system and methods for medical devices

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.

Growing community of inventors

Kaysville, UT, United States of America

Shayne Messerly