Ultrasound systems, probes, and methods provide the accuracy of tracking a needle's trajectory with in-plane visualization and the optimal views of anatomical structures associated with out-of-plane visualization. Such an ultrasound system for needle tracking and guidance can include an ultrasound probe having an imaging array and a linear tracking array perpendicular to the imaging array. A console of the ultrasound system can include memory having executable instructions that instantiate system processes for imaging with the imaging array as well as needle tracking with the tracking array when executed by one or more processors. An image-generating process generates ultrasound images of a target area or anatomical structure thereof from echoed ultrasound signals corresponding to the patient. A needle-tracking process generates needle-tracking data from the echoed ultrasound signals corresponding to a needle. A needle-guiding process provides on-screen guidance of the needle to the target area or anatomical structure thereof.
Ultrasound systems, probes, and methods provide the accuracy of tracking a needle's trajectory with in-plane visualization and the optimal views of anatomical structures associated with out-of-plane visualization. Such an ultrasound system for needle tracking and guidance can include an ultrasound probe having an imaging array and a linear tracking array perpendicular to the imaging array. A console of the ultrasound system can include memory having executable instructions that instantiate system processes for imaging with the imaging array as well as needle tracking with the tracking array when executed by one or more processors. An image-generating process generates ultrasound images of a target area or anatomical structure thereof from echoed ultrasound signals corresponding to the patient. A needle-tracking process generates needle-tracking data from the echoed ultrasound signals corresponding to a needle. A needle-guiding process provides on-screen guidance of the needle to the target area or anatomical structure thereof.
A fiber-optic assembly for insertion in a patient, includes a shape sensing optical fiber and a mechanical layer surrounding a distal section of the optical fiber. The distal section includes an optical fiber tip and an expansion configured to inhibit damage of the optical fiber tip. The expansion includes a proximal end proximal of the optical fiber tip, a distal end distal of the optical fiber tip, and a diameter greater than a diameter of the shape sensing optical fiber. The optical fiber can include a plurality of optical fiber cores. One or more of the plurality of optical fiber cores can include a plurality of sensors distributed along at least the distal portion of the optical fiber configured to project reflected light signals proximally along the optical fiber to indicate a shape of the optical fiber.
A61B 34/20 - Surgical navigation systemsDevices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
A61B 1/07 - Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopesIlluminating arrangements therefor with illuminating arrangements using light-conductive means, e.g. optical fibres
A61B 5/06 - Devices, other than using radiation, for detecting or locating foreign bodies
A rapidly inserted central catheter can include a catheter tube, a catheter hub, and one or more extension legs. The catheter tube can include a single-piece catheter tip coupled to a distal end portion of the catheter tube having a first section, a second section, and a third section. The first section of the catheter tip can have a uniform taper over an outer diameter thereof for dilating tissue around a needle tract from a size commensurate with an outer diameter of a needle shaft to a size commensurate with an outer diameter of the second section of the catheter tip. The third section of the catheter tip can have a non-uniform taper over an outer diameter thereof for dilating the tissue from the size commensurate with the outer diameter of the second section of the catheter tip to a size commensurate with an outer diameter of the catheter tube.
A medical device connector module, including a housing, a cable extending from the housing, and an optical fiber. The housing includes a receptacle configured to receive a first plug to establish an optical connection between a medical device and the medical device connector module. The housing further includes a plurality of sensors configured to provide sensor data for determining a reference plane for shape sensing. The plurality of sensors include a gyroscope and an accelerometer. The cable includes a second plug. The optical fiber extends from the receptacle through the cable to the second plug. The optical fiber is configured to convey input optical signals from the optical interrogator to the receptacle and reflected optical signals from the receptacle to the optical interrogator.
Systems, devices, and methods for performing vascular treatments and diagnoses. A vascular device includes an optical fiber including a single fiber core disposed offset from a central axis of the optical fiber. The single fiber enables logic of the system to determine multiple conditions of the device and the patient. The conditions may include one or more of blood flow parameters, infusate delivery parameters, location of the device within the patient, pH of the blood, oxygen level of the blood, damage to the optical fiber, or core temperature of the patient. The elongate medical device may be a catheter, a stylet, a guidewire, or a probe.
A61B 5/1459 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter
A61B 1/00 - Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopesIlluminating arrangements therefor
A61B 1/06 - Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopesIlluminating arrangements therefor with illuminating arrangements
A61B 1/07 - Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopesIlluminating arrangements therefor with illuminating arrangements using light-conductive means, e.g. optical fibres
A61B 1/12 - Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopesIlluminating arrangements therefor with cooling or rinsing arrangements
A61B 1/313 - Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopesIlluminating arrangements therefor for introducing through surgical openings, e.g. laparoscopes
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/0205 - Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1455 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using optical sensors, e.g. spectral photometrical oximeters
A61B 34/20 - Surgical navigation systemsDevices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
A retractable intraosseous access system configured to transition between an active state and one of a folded state or a retracted state. In the folded state, the access assembly can be pivoted relative to the driver to collapse the access assembly against a handle. In the retracted state, the access assembly is slidably received within a housing of the driver. Advantageously, the retractably intraosseous access system can provide an “all-in-one” design that does not require assembling separate components. Further the retractably intraosseous access system can provide a compact outer profile requiring reduced storage space.
Systems and methods for tracking medical devices such as needles and catheters. For example, an ultrasound-imaging system is configured to perform a set of operations for accessing a blood vessel, recommending a proper approach angle for approaching the blood vessel with the medical device, recommending a proper insertion angle for inserting the medical device in the blood vessel, ensuring a final placement of a sufficient length of the medical device within the blood vessel, and following, or tracking, a procedure for placing the medical device in the blood vessel. In addition, the ultrasound-imaging system is configured to perform a set of operations for optimizing an ultrasound image about the blood vessel or a targeted location of the blood vessel.
A blood vessel access system includes a vascular assessment device configured to acquire raw image data of a vasculature of the patient and a system module. The system module can include a console coupled with the vascular assessment device, the console including a processor and a memory having logic stored thereon that, when executed by the processor, performs operations including receiving the raw image data from the vascular assessment device, determining meta data for the vasculature from the raw image data, and applying a trained machine learning model to the meta data to determine a difficult venous access assessment for the vasculature. The blood vessel access system can perform a difficult venous access assessment, including applying a machine learning algorithm to a plurality of historical difficult venous access assessment data sets to train a machine learning model that relates meta data and three dimensional imaging data to corresponding assessments.
A catheter placement system for placing a catheter, the system including a stylet with an optical fiber (135) extending therethrough, a stylet body (290) extending between a proximal end and a distal tip (290). A console (20), equipped with optical logic, delivers broadband incidence light to the optical fiber and receives reflected light signals to determine positional information about the stylet body. The stylet body is configured to be separable at a point between the proximal end and distal tip to allow a catheter to be advanced over a distal portion of the stylet body. The distal portion is configured to be reattached to the proximal portion to reconfirm the position of the stylet body distal tip prior to removal of the stylet from the catheter. The system further includes a severing device that is easy to actuate and ensures a clean, perpendicular cut to facilitate reconnection between the proximal and distal portions.
A catheter placement system for placing a catheter, the system includes a stylet with an optical fiber extending therethrough, the stylet body extending between a proximal end and a distal tip. A console, equipped with optical logic, delivers broadband incidence light to the optical fiber and receives reflected light signals to determine positional information about the stylet body. The stylet body is configured to be separable at a point between the proximal end and distal tip to allow a catheter to be advanced over a distal portion of the stylet body. The distal portion is configured to be reattached to the proximal portion to reconfirm the position of the stylet body distal tip prior to removal of the stylet from the catheter. The system further includes a severing device that is easy to actuate and ensures a clean, perpendicular cut to facilitate reconnection between the proximal and distal portions.
An ultrasound imaging system configured to assess the impact of placement of a vascular access device on fluid flow through 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 a Doppler array configured to detect the fluid flow through a region of interest of the target vessel. The ultrasound imaging system further includes a console in communication with each of the ultrasound array and the Doppler array, the console configured to determine the region of interest of the target vessel.
An intrauterine device (IUD) may include a magnetic field source and/or a shape sensing optical fiber that enables positional tracking of the IUD during placement. An insertion device (ID) for the IUD may also include a magnetic field source and/or a shape sensing optical fiber. An IUD placement system includes logic that processes magnetic field sensing data and/or optical shape sensing data to determine a real-time position and/or an orientation of the IUD or the ID with respect to the uterus during placement of the IUD. Logic may render, on a display, visual representations of the uterus and/or ultrasound images of the uterus obtained by an ultrasound probe of the system. Logic further overlays, atop the visual representations of the uterus and/or ultrasound images of the uterus, visual representations of the IUD or the ID at the real-time position and/or orientation.
A tactile-feedback system (104) for a guidewire-containing medical device (100) includes a guidewire (108)and a rigid member (110) in vibratory communication with a handholdable portion (112) of the medical device. The guidewire includes interactive features (118) along its length. The interactive features of the guidewire interact with the rigid member to produce user-perceptible vibrations in the handholdable portion of the medical device as the guidewire moves against the rigid member while being advanced out of the medical device or retracted into the device. The user-perceptible vibrations provide tactile feedback to a user of the medical device indicating a status of the guidewire with respect to a patient or the medical device.
A tactile-feedback system and method for guidewire-containing medical devices facilitates locating a guidewire within both a medical device and a blood vessel of a patient. In an example, a tactile-feedback system for a guidewire-containing medical device includes a guidewire and a rigid member in vibratory communication with a handholdable portion of the medical device. The guidewire includes interactive features along its length. The interactive features of the guidewire interact with the rigid member to produce user-perceptible vibrations in the handholdable portion of the medical device as the guidewire moves against the rigid member while being advanced out of the medical device or retracted into the device. The user-perceptible vibrations provide tactile feedback to a user of the medical device indicating a status of the guidewire with respect to a patient or the medical device.
A medical device visualization system includes a stylet, a plurality of patient-wearable sensors, and a console. The stylet includes an optical fiber with a plurality of sensors distributed along a length thereof, and a field generator in a distal tip. The plurality of patient-wearable sensors are configured to sense a field generated by the field generator. The console is configured for visualizing the stylet as it is advanced in a patient. A visualization process can include a shape-sensing process, a registration process, and a reference-framing process. The shape-sensing process can utilize shape-sensing logic for determining a shape of the stylet in real-time from reflected optical signals reflected by the plurality of sensors. The registration process can utilize registration logic for registering the distal tip of the stylet. The reference-framing process can utilize reference-framing logic for placing the stylet in a reference frame.
A61B 5/06 - Devices, other than using radiation, for detecting or locating foreign bodies
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 34/10 - Computer-aided planning, simulation or modelling of surgical operations
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
18.
Anatomical Oscillation and Fluctuation Sensing and Confirmation System
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.
A61B 5/06 - Devices, other than using radiation, for detecting or locating foreign bodies
A61B 5/113 - Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb occurring during breathing
A61B 5/318 - Heart-related electrical modalities, e.g. electrocardiography [ECG]
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
The ultrasound probe cover system comprises a cradle arm supporting an ultrasound probe in a predetermined position, a first applicator arm articulating relative to the cradle arm and housing a sterilizer applicator and a gel applicator for applying a sterilizing agent and a gel to the probe head, and a sheath arm with a sheath holder supporting an open sheath. The sheath arm articulates relative to the cradle arm to position the sheath opening over the probe head. The sheath includes a biasing member extending helically and configured to bias the sheath to an extended configuration to facilitate placing the sheath over the probe. The cover system provides a convenient and efficient solution for covering and preparing ultrasound probes for medical procedures, enhancing hygiene and usability in healthcare settings.
The ultrasound probe cover system comprises a cradle arm supporting an ultrasound probe in a predetermined position, a first applicator arm articulating relative to the cradle arm and housing a sterilizer applicator and a gel applicator for applying a sterilizing agent and a gel to the probe head, and a sheath arm with a sheath holder supporting an open sheath. The sheath arm articulates relative to the cradle arm to position the sheath opening over the probe head. The sheath includes a biasing member extending helically and configured to bias the sheath to an extended configuration to facilitate placing the sheath over the probe. The cover system provides a convenient and efficient solution for covering and preparing ultrasound probes for medical procedures, enhancing hygiene and usability in healthcare settings.
A medical-device visualization system includes an elongate medical device having passive electromagnetoresponsive ("EMR") elements distributed along a length thereof, a magnetic interrogator having magnetic transducers for transducing responses of the EMR elements to an external magnetic field, and a console for visualizing a shape of the medical device as it is advanced through a vasculature of a patient within the external magnetic field. A registration process of the console registers the EMR elements including a distalmost EMR element of the medical device at various magnetic transducers. A shape-sensing process senses the shape of the medical device from time-dependent location data for the EMR elements from the magnetic interrogator. A reference-framing process places the shape of the medical device in a patient-based reference frame following conversion of the location data from a magnetic interrogator-based coordinate system to a patient-based coordinate system in the patient-based reference frame.
A medical system is disclosed that includes a medical device having an optical fiber, and an interchangeable connection component configured to provide a fiber optic connection between the medical device and capital equipment. The connection component is configured to facilitate cleaning and/or polishing of fiber optic interfaces include therewith. The connection component is also configured for replacement by a medical technician while the capital equipment is operational. The capital equipment may include one or more of an optical interrogator, a patch cable, a medical probe, an ultrasound machine, a display, a magnet sensor, or an electro-cardiogram (ECG) machine. The medical device may include an elongate member configured for insertion within the patient body, where the optical fiber core extends along a length of the elongate member.
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
23.
MEDICAL-DEVICE NAVIGATION SYSTEMS WITH ELECTROMAGNETORESPONSIVE ELEMENTS
A medical-device navigation system includes, in some embodiments, an electromagnetoresponsive ("EMR") element, a magnetic interrogator, and a console. The magnetic interrogator generates an external magnetic field, transduces resonance-based responses of the EMR element thereto, and provides response data for the EMR element as an elongate portion of a medical device including the EMR element moves through the external magnetic field. The console instantiates medical-device navigation processes including a data- acquisition process, a triangulation process, and a plotting process for navigating the elongate portion of the medical device as it is advanced through the external magnetic field to a target location. The data-acquisition process acquires the response data from the magnetic interrogator over time, the triangulation process triangulates the EMR element with respect to magnetic sensors of the magnetic interrogator over time, and the plotting process plots a location of the EMR element on a display screen of the console over time.
Guidewires include a distal section, a proximal section and a middle section disposed between the distal section and the proximal section, wherein the middle section has a flexural stiffness that is greater than a flexural stiffness of both of the distal section and the proximal section. The distal section is configured for insertion into a vasculature of a patient. A diameter of the middle section may be greater than a diameter of the distal section. The guidewires may include a tapered distal transition portion disposed between the distal section and the middle section and a solid core wire extending a length of the guidewires, the solid core wire including a first diameter extending along the distal section, a second diameter extending along the proximal section, and a third diameter extending along the middle section, wherein the third diameter is greater than the first diameter and the second diameter.
A medical-device navigation system includes, in some embodiments, an electromagnetoresponsive (“EMR”) element, a magnetic interrogator, and a console. The magnetic interrogator generates an external magnetic field, transduces resonance-based responses of the EMR element thereto, and provides response data for the EMR element as an elongate portion of a medical device including the EMR element moves through the external magnetic field. The console instantiates medical-device navigation processes including a data-acquisition process, a triangulation process, and a plotting process for navigating the elongate portion of the medical device as it is advanced through the external magnetic field to a target location. The data-acquisition process acquires the response data from the magnetic interrogator over time, the triangulation process triangulates the EMR element with respect to magnetic sensors of the magnetic interrogator over time, and the plotting process plots a location of the EMR element on a display screen of the console over time.
A tracking and steering system for medical devices comprises a magnetic element attached to a distal portion of the medical device, a sensor on the patient's external surface detecting the magnetic field strength of the medical device's magnetic element, and a steering magnet on the patient's external surface with an electromagnet attracting the medical device's magnetic element. A console with memory and processors receives sensor data to determine the medical device's distal tip position and controls the sensor and steering magnet activation. A display shows an image of the patient with an icon indicating the medical device's location relative to the patient, enhancing medical procedures with real-time tracking and steering capabilities.
Photoacoustic medical-device navigation systems and methods provide alternatives to those incorporating fluoroscopy for medical-device navigation in patient bodies. A medical-device navigation system can include an optical-fiber stylet, ultrasound transducers, and a console. The stylet can transmit light to an instant location of a distal tip of an elongate medical device in a patient's body and, thereby, irradiate endogenous chromophores to generate ultrasound-frequency photoacoustic pressure waves therefrom. The ultrasound transducers can detect ultrasound signals corresponding to the photoacoustic pressure waves. The console can instantiate medical-device navigation processes for navigating the elongate medical device via the stylet as the elongate medical device is advanced to the target location in the patient's body. The medical-device navigation processes can include acquiring ultrasound-signal data from the ultrasound transducers, reconstructing images from the ultrasound-signal data, and displaying reconstructed images on a display for navigating the elongate medical device to the target location in the patient's body.
A system, apparatus and method directed to determining a temperature within 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, processing the reflected light signal to determine a temperature within the patient body near a measurement region. The method may include determining a location of a distal tip of the optical fiber within the patient body at least based on the temperature.
Medical-device visualization systems and methods utilize patient-based reference framing to improve shape sensing for elongate medical devices. A medical-device visualization system includes, in some embodiments, a stylet, patient-wearable sensors, and a console. The stylet includes an optical fiber and a field generator. Each of the patient-wearable sensors senses a field generated by the field generator. The console instantiates medical-device visualization processes for visualizing the elongate medical devices by way of at least the stylet. The medical-device visualization processes include a shape-sensing process, a registration process, and a reference-framing process. The shape-sensing process determines a shape of the stylet in real-time from reflected optical signals from the optical fiber. The registration process registers the distal tip of the stylet in real-time at each sensor of the patient-wearable sensors. And the reference-framing process places the stylet with its shape in a patient-based reference frame established by the patient-wearable sensors.
A system, apparatus and method directed to determining a temperature within 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, processing the reflected light signal to determine a temperature within the patient body near a measurement region. The method may include determining a location of a distal tip of the optical fiber within the patient body at least based on the temperature.
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/1455 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using optical sensors, e.g. spectral photometrical oximeters
A tracking and steering system for medical devices comprises a magnetic element attached to a distal portion of the medical device, a sensor on the patient's external surface detecting the magnetic field strength of the medical device's magnetic element, and a steering magnet on the patient's external surface with an electromagnet attracting the medical device's magnetic element. A console with memory and processors receives sensor data to determine the medical device's distal tip position and controls the sensor and steering magnet activation. A display shows an image of the patient with an icon indicating the medical device's location relative to the patient, enhancing medical procedures with real-time tracking and steering capabilities.
A61B 34/20 - Surgical navigation systemsDevices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
A61B 5/06 - Devices, other than using radiation, for detecting or locating foreign bodies
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
32.
Photoacoustic Medical-Device Navigation System and Methods
Photoacoustic medical-device navigation systems and methods provide alternatives to those incorporating fluoroscopy for medical-device navigation in patient bodies. A medical-device navigation system can include an optical-fiber stylet, ultrasound transducers, and a console. The stylet can transmit light to an instant location of a distal tip of an elongate medical device in a patient's body and, thereby, irradiate endogenous chromophores to generate ultrasound-frequency photoacoustic pressure waves therefrom. The ultrasound transducers can detect ultrasound signals corresponding to the photoacoustic pressure waves. The console can instantiate medical-device navigation processes for navigating the elongate medical device via the stylet as the elongate medical device is advanced to the target location in the patient's body. The medical-device navigation processes can include acquiring ultrasound-signal data from the ultrasound transducers, reconstructing images from the ultrasound-signal data, and displaying reconstructed images on a display for navigating the elongate medical device to the target location in the patient's body.
A magnetic signature imprinting system includes an imprinting device and a medical device having ferrous elements. The imprinting device can include an active area configured to receive the medical device. The active area can include one or more electromagnets configured to generate one or more electromagnetic fields to imprint a magnetic signature. The imprinting device can further include one or more sensors or a user input mechanism configured to detect one or more characteristics of the medical device and a console in communication with each of the electromagnets and the sensors.
H01F 13/00 - Apparatus or processes for magnetising or demagnetising
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
34.
Rapidly Insertable Central Catheters, Introducers, and Insertion Devices Including Combinations and Methods Thereof
Rapidly insertable central catheters (“RICCs”), introducers, and insertion devices including combinations and methods thereof are disclosed. For example, a RICC system can include an introducer and a RICC insertion assembly including a RICC assembly disposed in a RICC insertion device. The RICC assembly can include a RICC, an access guidewire, and a splittable casing over a catheter tube of the RICC and the access guidewire forming a longitudinal composite. The RICC insertion device can include a frame and a nose cover forming a split channel that splits away from a through channel of a nose of the frame. The RICC insertion device can be configured for advancing the RICC assembly by rolling the longitudinal composite across roller wheels disposed in the frame. The through channel can be configured for advancing the catheter tube therethrough while the split channel can be configured for both splitting and passing the splittable casing therethrough.
A system and method directed to detecting placement of a medical device within a patient body, the system including a medical device including a multi-core optical fiber having a plurality of core fibers. Each of the plurality of core fibers can include a plurality of sensors each configured to reflect a light signal having an altered characteristic due to strain experienced by the multi-core optical fiber. The system can further include logic configured to determine a 3D shape of the medical device in accordance with the strain of the optical fiber. The logic can be configured to define a reference plane for the 3D shape and render an image of the 3D shape on a display of the system in accordance with the reference plane.
Catheter clips and catheter insertion assemblies including such catheter clips facilitate sterile catheterization technique, thereby reducing the risk of catheter-related bloodstream infections and increasing positive patient-centered outcomes. In an example, a catheter clip can include a pair of lever arms mated to each other. Each lever arm of the pair of lever arms can be bilaterally asymmetric but identical to the other lever arm of the pair of lever arms. An elastomeric band can be over a jaw end portion of the catheter clip. A catheter retainer can be coupled to a handle end portion of the catheter clip. The catheter retainer can be configured to hold a catheter connector of a catheter such that at least a proximal portion of the catheter remains in a sterile field when the catheter clip is clipped onto a sterile drape that establishes at least a portion of the sterile field.
Catheter clips (110) and catheter insertion assemblies including such catheter clips facilitate sterile catheterization, thereby reducing the risk of catheter-related bloodstream infections. A catheter clip (110) can include a pair of lever arms (142) mated to each other. Each lever arm of the pair of lever arms can be bilaterally asymmetric but identical to the other lever arm of the pair of lever arms. An elastomeric band (150) can be over a jaw end portion of the catheter clip. A catheter retainer (152) can be coupled to a handle end portion of the catheter clip. The catheter retainer can be configured to hold a catheter connector of a catheter such that at least a proximal portion of the catheter remains in a sterile field when the catheter clip is clipped onto a sterile drape that establishes at least a portion of the sterile field.
A medical system module configured to provide instructions to a user includes an input module configured to receive input pertaining to medical procedures to be performed on a patient by a user utilizing the medical system and an output module configured to provide to the user instructions for performing the medical procedures. Logic operations of the system include defining a set of the instructional steps to be followed during a performance of a selected medical procedure. A medical system can include magnetic tracking of a medical device and determining a shape of the medical device optical fiber shape sensing. Logic operations can include Artificial intelligence techniques. Providing user instructions can include pictorial illustrations as well as textual instructions. Pictorial illustrations can include historical image or other visual representations previously recorded and stored in memory. Logic determines completion of instructional steps by comparing a live visual representation with historical visual representations.
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 wavelengths, 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.
A61M 25/01 - Introducing, guiding, advancing, emplacing or holding catheters
A61B 1/07 - Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopesIlluminating arrangements therefor with illuminating arrangements using light-conductive means, e.g. optical fibres
A61B 5/06 - Devices, other than using radiation, for detecting or locating foreign bodies
A61B 34/20 - Surgical navigation systemsDevices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
An occlusive dressing and medical device system (100) includes a medical device (150) having a hub (160) featuring an occlusive surface (170). The occlusive surface can extend over a plane parallel to a patient's skin surface. A catheter tube (152) can extend through an insertion site in the skin surface and is supported at a proximal end by the hub. An extension leg (158) and/or connector (156) can extend from the occlusive surface. The system also includes a dressing with adhesive to attach to the hub and the skin surface. The dressing can include a fenestration (118) disposed within an outer perimeter of the dressing (116), which receives the extension leg and/ or connector therethrough and an edge of the fenestration engages and adheres to the occlusive surface along the entire circumference of the edge. The engagement between the fenestration and the hub can mitigate the formation of pathogen pathways underneath the dressing to reduce the risk of infection.
Disclosed herein is a catheter, which in some embodiments includes a distal section configured to enter a skin insertion site. The distal section can include a tapered junction having one or more dilation structures configured to dilate the skin insertion site. The distal section can further include a distal portion extending from a distal end of the tapered junction, the distal portion having a diameter smaller than a proximal portion of the catheter. In combination, the tapered junction, the one or more dilation structures, and the specific actions of the user urging the catheter into the insertion site can result in an improved fit of the catheter in the insertion site.
An introducer can include an introducer needle (134) and an introducer sheath (136) having a transition therebetween that eases tissue over a distal end of the introducer sheath without catching tissue thereon tissue despite an excised portion of the introducer needle. The introducer needle can include a needle shaft (140) having a longitudinal needle slot (146) extending from a proximal portion of the needle shaft through a distal needle tip (144), which results in an excised portion of a heel of a bevel (150) of the needle tip. The introducer sheath can include a sheath body (162) and a tapered sheath tip (170). The sheath body can be over the needle shaft sealing the needle slot thereunder but for a sheath-body opening (166) in a proximal portion of the sheath body for an access guidewire.
A system, apparatus and method directed to detecting malposition of a medical device within a vessel of a patient, such as an Azygos vein. The medical device can include a multi-core optical fiber including a plurality of core fibers, where each of the plurality of core fibers includes a plurality of sensors is configured to reflect a light signal based on received incident light, and change a characteristic of the reflected light signal for use in determining a physical state of the multi-core optical fiber. The system can include a console having non-transitory computer-readable medium storing logic that, when executed, causes operations of providing a broadband incident light signal to the multi-core optical fiber, receiving reflected light signals, processing the reflected light signals, and determining whether the medical device has entered the Azygos vein of the patient based on the reflected light signals.
A61B 34/20 - Surgical navigation systemsDevices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
A61B 5/06 - Devices, other than using radiation, for detecting or locating foreign bodies
G01D 5/353 - Mechanical means for transferring the output of a sensing memberMeans for converting the output of a sensing member to another variable where the form or nature of the sensing member does not constrain the means for convertingTransducers not specially adapted for a specific variable using optical means, i.e. using infrared, visible or ultraviolet light with attenuation or whole or partial obturation of beams of light the beams of light being detected by photocells influencing the transmission properties of an optical fibre
An introducer can include an introducer needle and an introducer sheath having a transition therebetween that eases tissue over a distal end of the introducer sheath without catching tissue thereon tissue despite an excised portion of the introducer needle. The introducer needle can include a needle shaft having a longitudinal needle slot extending from a proximal portion of the needle shaft through a distal needle tip, which results in an excised portion of a heel of a bevel of the needle tip. The introducer sheath can include a sheath body and a tapered sheath tip. The sheath body can be over the needle shaft sealing the needle slot thereunder but for a sheath-body opening in a proximal portion of the sheath body for an access guidewire. The introducer can include the transition from the bevel of the needle tip to at least the taper of the sheath tip.
Medical-device visualization systems and methods utilize patient-based reference framing to improve shape sensing for elongate medical devices. A medical-device visualization system includes, in some embodiments, a stylet, patient-wearable sensors, and a console. The stylet includes an optical fiber and a field generator. Each of the patient-wearable sensors senses a field generated by the field generator. The console instantiates medical-device visualization processes for visualizing the elongate medical devices by way of at least the stylet. The medical-device visualization processes include a shape-sensing process, a registration process, and a reference-framing process. The shape-sensing process determines a shape of the stylet in real-time from reflected optical signals from the optical fiber. The registration process registers the distal tip of the stylet in real-time at each sensor of the patient-wearable sensors. And the reference-framing process places the stylet with its shape in a patient-based reference frame established by the patient-wearable sensors.
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/06 - Devices, other than using radiation, for detecting or locating foreign bodies
A61B 34/10 - Computer-aided planning, simulation or modelling of surgical operations
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
46.
GUIDEWIRE SURFACE MODIFICATION TO REDUCE DRAG FORCE
A guidewire (150) having a modified surface to reduce drag force between the outer surface of the guidewire and an inner surface of the catheter lumen (114). Preloaded catheter systems (100) include a guidewire disposed within a lumen of the catheter (110). The guidewire is equal to, or slightly smaller than an inner diameter of the catheter lumen to impart columnar strength to the catheter during placement. However, due to increase contact surface area between the guidewire and the catheter lumen, the guidewire can stick within catheter lumen requiring increase force to slide the guidewire relative to the catheter. Surface modifications on the guidewire can reduce the contact surface are between the guidewire and catheter resulting in a reduced drag force therebetween. A plurality of longitudinal grooves (156), disposed in a regular or irregular pattern, and reduce drag force without affecting the flexible properties of the guidewire.
An intraosseous access system includes an intraosseous driver having socket configured to receive a shaft of an obturator assembly. An O-ring disposed within a groove of the shaft inhibits removal of the shaft from the socket. The O-ring can be compressed within the groove to define a frictional force between the socket and the shaft. The socket can include recesses and the O-ring may expand into the recesses to inhibit removal of the shaft from the socket. The driver can include a latch mechanism configured to selectively prevent removal of the shaft and allow removal of the shaft. An adapter can be positioned between the driver and obturator assembly where the adapter includes the latch mechanism. The latch mechanism include an actuator to selectively transition the latch mechanism between a retaining state and a releasing state.
An intraosseous access system includes an intraosseous driver having socket configured to receive a shaft of an obturator assembly. An O-ring disposed within a groove of the shaft inhibits removal of the shaft from the socket. The O-ring can be compressed within the groove to define a frictional force between the socket and the shaft. The socket can include recesses and the O-ring may expand into the recesses to inhibit removal of the shaft from the socket. The driver can include a latch mechanism configured to selectively prevent removal of the shaft and allow removal of the shaft. An adapter can be positioned between the driver and obturator assembly where the adapter includes the latch mechanism. The latch mechanism include an actuator to selectively transition the latch mechanism between a retaining state and a releasing state.
An ultrasound-imaging system includes an ultrasound probe coupled with a console. Operations of the system can include detecting one or more blood vessels within the ultrasound image and identifying each blood vessel as a vein, an artery or other anatomic element using doppler ultrasound functionality of the ultrasound probe. Operations can also include determining a confidence for the blood vessel identification and defining a window for doppler ultrasound operation. Operations can further include assessing a blood flow rate within blood vessels, and superimposing notifications atop the ultrasound image pertaining to the identity of the blood vessel including a confidence for the identity.
A clinical bedside system facilitates care for complex care patients. The system can include a medical device having a biosensor with an inert substrate and a working electrode, a counter electrode, and a reference electrode deposited thereon. The working electrode can have an antifouling membrane thereover to which a capture antibody is immobilized. The capture antibody can be configured to capture a biomarker between it and a detection antibody, thereby sandwiching the infection biomarker between the antibodies for a detectable redox reaction between an enzyme conjugated to the detection antibody and the working electrode. The counter electrode can complete completes an electrical circuit including the working electrode. The reference electrode can be operably connected to the electrical circuit. The reference electrode can be configured to provide a reference point against which changes in potential at the working electrode can be measured, for example, with a potentiostat.
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions
G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
51.
Guidewire Surface Modification to Reduce Drag Force
A guidewire having a modified surface to reduce drag force between the outer surface of the guidewire and an inner surface of the catheter lumen. Preloaded catheter systems include a guidewire disposed within a lumen of the catheter. The guidewire is equal to, or slightly smaller than an inner diameter of the catheter lumen to impart columnar strength to the catheter during placement. However, due to increase contact surface area between the guidewire and the catheter lumen, the guidewire can stick within catheter lumen requiring increase force to slide the guidewire relative to the catheter. Surface modifications on the guidewire can reduce the contact surface are between the guidewire and catheter resulting in a reduced drag force therebetween. A plurality of longitudinal grooves, disposed in a regular or irregular pattern, and reduce drag force without affecting the flexible properties of the guidewire.
A shape-sensing system includes electromagnetoresponsive elements along a length of an elongate medical device that respond to an external magnetic field generated by a magnetic interrogator. The magnetic interrogator transduces responses of the electromagnetoresponsive elements, thereby collecting location-dependent response data therefrom as they move through the external magnetic field. A console converts the location-dependent response data into raw 3D location data. The console can interpolate the raw 3D location data, thereby generating estimated 3D location data for one or more portions of the medical device between any two electromagnetoresponsive elements to provide plottable 3D location data. The console can further plot the plottable 3D location data on a display screen of the console in real-time as the medical device and the electromagnetoresponsive elements associated therewith move through the external magnetic field, thereby displaying a graphical representation of the medical device per its location, shape, and orientation in 3D space.
A clinical bedside system facilitates care for complex care patients. The system can include a medical device having a biosensor with an inert substrate and a working electrode, a counter electrode, and a reference electrode deposited thereon. The working electrode can have an antifouling membrane thereover to which a capture antibody is immobilized. The capture antibody can be configured to capture a biomarker between it and a detection antibody, thereby sandwiching the infection biomarker between the antibodies for a detectable redox reaction between an enzyme conjugated to the detection antibody and the working electrode. The counter electrode can complete completes an electrical circuit including the working electrode. The reference electrode can be operably connected to the electrical circuit. The reference electrode can be configured to provide a reference point against which changes in potential at the working electrode can be measured, for example, with a potentiostat.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
54.
SYSTEMS AND METHODS OF SHAPE SENSING MEDICAL DEVICES WITH ELECTROMAGNETORESPONSIVE ELEMENTS
A shape-sensing system includes electromagnetoresponsive elements along a length of an elongate medical device that respond to an external magnetic field generated by a magnetic interrogator. The magnetic interrogator transduces responses of the electromagnetoresponsive elements, thereby collecting location-dependent response data therefrom as they move through the external magnetic field. A console converts the location-dependent response data into raw 3D location data. The console can interpolate the raw 3D location data, thereby generating estimated 3D location data for one or more portions of the medical device between any two electromagnetoresponsive elements to provide plottable 3D location data. The console can further plot the plottable 3D location data on a display screen of the console in real-time as the medical device and the electromagnetoresponsive elements associated therewith move through the external magnetic field, thereby displaying a graphical representation of the medical device per its location, shape, and orientation in 3D space.
Needle-guiding systems and methods can facilitate establishing vascular access with a nonmagnetic needle. For example, a method of a needle-guiding system can include detecting and registering registration marks about a patient by patient-facing cameras of an alternative reality (“AR”) device, the AR device thereby establishing its location and orientation relative to a target area of the patient. The method can also include anchoring ultrasound images of the target area as viewed through a display screen of the AR device, the ultrasound images anchored about the patient relative to either an instant or previous location and orientation of the ultrasound probe; and providing an instant virtual needle trajectory of the needle as viewed through the display screen of the AR device, thereby indicating to a clinician whether the needle is properly oriented for establishing vascular access to a target vessel of the ultrasound images.
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
A medical imaging system including an optical identifier camera for imaging a medical device, a medical device packaging, a patient, or a technician. The system further includes an imaging probe for imaging of a target location, and a console with optical identifier logic to extract identifier markers or characteristics from the image of the medical device, packaging, patient or technician. A parameter logic determines the medical imaging parameters based on the identifiers or characteristics, and a medical imaging logic captures medical images of the medical device. The system enables efficient and accurate imaging of medical devices on the specific patient, by a specific technician, enhancing diagnostic capabilities and treatment planning in medical parameters.
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
A61B 90/98 - Identification means for patients or instruments, e.g. tags using electromagnetic means, e.g. transponders
57.
NEEDLE-GUIDING SYSTEMS AND METHODS FOR ESTABLISHING VASCULAR ACCESS
Needle-guiding systems and methods can facilitate establishing vascular access with a nonmagnetic needle. For example, a method of a needle-guiding system can include detecting and registering registration marks about a patient by patient-facing cameras of an alternative reality ("AR") device, the AR device thereby establishing its location and orientation relative to a target area of the patient. The method can also include anchoring ultrasound images of the target area as viewed through a display screen of the AR device, the ultrasound images anchored about the patient relative to either an instant or previous location and orientation of the ultrasound probe; and providing an instant virtual needle trajectory of the needle as viewed through the display screen of the AR device, thereby indicating to a clinician whether the needle is properly oriented for establishing vascular access to a target vessel of the ultrasound images.
A medical imaging system including an optical identifier camera for imaging a medical device, a medical device packaging, a patient, or a technician. The system further includes an imaging probe for imaging of a target location, and a console with optical identifier logic to extract identifier markers or characteristics from the image of the medical device, packaging, patient or technician. A parameter logic determines the medical imaging parameters based on the identifiers or characteristics, and a medical imaging logic captures medical images of the medical device. The system enables efficient and accurate imaging of medical devices on the specific patient, by a specific technician, enhancing diagnostic capabilities and treatment planning in medical parameters.
A medical method includes providing an interrogation signal from a radio frequency identification (RFID) emitter communicatively coupled to a console. The interrogation signal can impinge on a plurality of RFID tags in a medical device tray. Each of the plurality of RFID tags can be associated with a respective medical device of a plurality of medical devices. The method further includes receiving a response signal from each of the plurality of RFID tags. The response signal can include information pertaining to the respective medical device. The information can include an order of use in a medical procedure.
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
A61B 90/98 - Identification means for patients or instruments, e.g. tags using electromagnetic means, e.g. transponders
G06K 7/10 - Methods or arrangements for sensing record carriers by electromagnetic radiation, e.g. optical sensingMethods or arrangements for sensing record carriers by corpuscular radiation
60.
Fiber Optic Medical Systems and Methods for Identifying Blood Vessels
Medical systems, devices, and methods for determining whether a blood vessel is a vein or 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. The state or condition can include a strain, movement, pressure, and/or temperature. The logic is configured to analyze reflected signals from the sensors to determine whether the optical fiber is inserted within an artery or within a vein. The logic may also determine a red-blue shift of a projected light to determine a blood flow direction with respect to the optical fiber.
A method of providing sterile medical devices including placing medical devices within a container along with a source of sterilizing gas to define a kit at a kitting facility. Closing the container enables exposure of the medical devices to the sterilizing gas to sterilize the medical devices. The container is opened at a point of use location where the medical devices are removed from the container. The source of sterilizing gas includes a plastic material impregnated with iodine. The medical devices may be selected from a population of received at the kitting facility from one or more medical device companies based on a selected medical procedure. The source of sterilizing gas container and bulk packaging can be reusable. The kit can be provided to the point of use location in a just-in-time fashion.
B01J 20/00 - Solid sorbent compositions or filter aid compositionsSorbents for chromatographyProcesses for preparing, regenerating or reactivating thereof
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.
A needle assembly includes a needle (130) and a needle cap (124) configured to encapsulate a needle tip after use. The needle cap is transitionable between (i) an extended position with respect to the needle cap, where the needle extends through a distal opening of the needle cap such that a distal tip of the needle extends distally beyond the distal end of the needle cap; and (ii) a retracted position with respect to the needle cap, where the distal tip is disposed within the needle cap. An obstructor, rotationally disposed within the needle cap transitions from a non-obstructing state to an obstructing state to prevent the distal tip of the needle from extending distally beyond the distal end of the needle cap in the obstructing state. Tension in a tether extending between a needle hub and the needle cap, enables decoupling of a medical device (114) from the needle cap.
A61M 25/06 - Body-piercing guide needles or the like
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A guidance system for guiding insertion of a medical device toward a target within target area a patient utilizes ultrasound or other suitable technology. The guidance system can include a device guidance module (e.g., an ultrasound probe) for producing target data of the target area. The device guidance module provides sensory feedback including visual, haptic and/or audio feedback based on a determined position of the medical device. One or more sensors detect a magnetic field generated by the medical device. Providing the sensory feedback may include adjusting a variable characteristic of the sensory feedback based on determining a variable position of the medical device. The system may include a processor that can receive magnetic field data sensed by the at-least-one sensor to determine the position of the needle. The system specifically omits depicting an image of a target area of the patient on a display.
A medical system includes an elongate vascular device having an optical fiber and a sensor module configured to detect pressure pulses at the skin surface resulting light pulses projected from a distal tip of the optical fiber within the vasculature of a patient. Logic of a system console processes pressure pulse data using photo-acoustic imaging techniques to obtain an image the vasculature. The processing also can include determining properties of the vasculature, such as a cross-sectional size of the vasculature, and determines therefrom a location of the distal tip.
An ultrasound system can simultaneously disinfect skin of a patient while ultrasound imaging thereunder. The ultrasound system can include a console, an ultrasound probe operably connected to the console, and a stimuloresponsive antimicrobial ultrasound gel selected from at least a sonoresponsive antimicrobial ultrasound gel and a photoresponsive antimicrobial ultrasound gel. The ultrasound probe can include an ultrasound sensor array for both the ultrasound imaging and the disinfecting of the skin with the sonoresponsive antimicrobial ultrasound gel via one or more sonosensitizers thereof. The ultrasound probe can also include one or more light emitters configured to emit light toward the skin for the disinfecting of the skin with the photoresponsive antimicrobial ultrasound gel via one or more photosensitizers thereof.
A medical device system includes a stylet with an optical fiber and a console operatively coupled to the stylet. The optical fiber can include an electrically conductive concentric tube configured to transmit electrical signals and a plurality of core fibers within the concentric tube. Each of the plurality of core fibers can include a plurality of sensors, and each the plurality of sensors can be configured to reflect a light signal of a different spectral width based on received incident light and change a characteristic of the reflected light signal based on a condition experienced by the stylet. The console includes one or more processors and a non-transitory computer-readable medium with logic that causes operations including providing an incident light signal to the optical fiber and receiving reflected light signals of different spectral widths of the received incident light by the plurality of sensors.
A61B 34/20 - Surgical navigation systemsDevices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
A61B 1/00 - Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopesIlluminating arrangements therefor
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A connection system including a device connector coupled with an equipment connector through a sterile barrier to define an electrical and optical connection. The sterile barrier includes a tubular portion and when connected, a portion of the device connector is disposed in the tubular portion and the tubular portion is disposed within a cavity of the equipment connector. The optical connection and electrical connection are established with the cavity of the equipment connector, the tubular portion, and a cavity of the equipment connector. A detent mechanism secures the device connector to the equipment and provides haptic feedback upon connection. The connection system can be employed by a medical system configured to track the location of a distal tip of a medical device within a patent body.
A system and method including operations of generating an ultrasound image screen including an ultrasound image,, the ultrasound image screen including a first user selection element configured to receive a first user input for selecting a blood vessel for display in the ultrasound image. The system and method can further include generating a parameter input screen. The parameter input screen can include a second user selection element configured to receive a second user input for selecting an angle of insertion of a medical device, a third user selection element configured to receive a third user input for increasing or decreasing a minimum dwell length of the medical device, and a graphical representation of the medical device depicting a selected angle of insertion and a selected minimum dwell length of the medical device.
Optical-fiber stylet holders and methods for holding optical-fiber stylets in position in catheters or the like prevent breakage of optical fibers in the optical-fiber stylets and maintain functionality of the optical-fiber stylets. The holding of optical-fiber stylets in position in catheters or the like can be important for maintaining distal tips of intravascularly delivered optical-fiber stylets in their target anatomical locations during procedures.
A61M 25/01 - Introducing, guiding, advancing, emplacing or holding catheters
A61B 1/07 - Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopesIlluminating arrangements therefor with illuminating arrangements using light-conductive means, e.g. optical fibres
71.
Ultrasound Imaging System Having Near-Infrared/Infrared Detection
Disclosed herein is an ultrasound imaging system including an ultrasound probe and a blood vessel visualization device. The ultrasound probe includes an ultrasound generation device and is configured to detect one or more blood vessels. The blood vessel visualization device is configured to project a depiction of the blood vessel topography within a target area. The blood vessel visualization device can include one or more near-infrared/infrared emitters configured to generate infrared/near-infrared waves within the target area, one or more near-infrared/infrared sensors configured to detect the difference in reflective properties of tissue and blood vessels within the target area, and one or more visual light projectors configured to project a blood vessel visualization depiction of the blood vessel topography onto the target area.
A needle guidance system includes a patient imaging system, such as an ultrasound guidance system (UGS) combined with a needle tip location system (TLS). The UGS defines a needle pathway to access an epidural/ spinal space and overlays the pathway onto a live or frozen ultrasound image. The TLS magnetically determines a magnetic distal tip location of the needle including a depth with respect to a magnetic field sensor placed on the patient. A distal tip image overlayed atop the ultrasound image at a determined distal tip location. The UGS identifies the epidural/ spinal space including a depth thereof within the ultrasound image. The UGS determines that the distal tip is located within the epidural/ spinal space when the depth of the distal tip equals the depth of the epidural/ spinal space. A probe securing apparatus secures an ultrasound probe of the UGS to the patient.
An accessory device (100) for an ultrasound system (10) includes an inverted U-shaped clamp portion (210) configured to attach to an ultrasound probe connector (50) and a hook portion (250) configured to receive therein a portion of an ultrasound cable (30). The hook extends laterally beyond a right side of the system module. The hook portion is rotated and laterally positioned offset with respect to clamp portion. Left and right legs (224, 226) of the clamp portion include at least one of a longitudinal curve, a lateral curve, or one or more inward protrusions (334, 336). An ultrasound probe assembly may include the cable management device. The accessory device may be formed integrally with the ultrasound probe connector. Additional accessory devices include a probe holder (520) and cable spool (600). Combination accessory devices may include any combination of the hook, the probe holder or the cable spool coupled with the clamp. Ultrasound probe assemblies may include any of the accessory devices.
B65H 75/12 - Kinds or types of circular or polygonal cross-section with a single end flangeKinds or types of circular or polygonal cross-section formed with one end of greater diameter than the barrel
A61B 8/00 - Diagnosis using ultrasonic, sonic or infrasonic waves
B65H 75/14 - Kinds or types of circular or polygonal cross-section with two end flanges
B65H 75/28 - Arrangements for securing ends of material
A needle guidance system includes a patient imaging system, such as an ultrasound guidance system (UGS) combined with a needle tip location system (TLS). The UGS defines a needle pathway to access an epidural/ spinal space and overlays the pathway onto a live or frozen ultrasound image. The TLS magnetically determines a magnetic distal tip location of the needle including a depth with respect to a magnetic field sensor placed on the patient. A distal tip image overlayed atop the ultrasound image at a determined distal tip location. The UGS identifies the epidural/ spinal space including a depth thereof within the ultrasound image. The UGS determines that the distal tip is located within the epidural/ spinal space when the depth of the distal tip equals the depth of the epidural/ spinal space. A probe securing apparatus secures an ultrasound probe of the UGS to the patient.
Rapidly insertable central catheter (“RICC”) assemblies include a RICC and an introducer. The RICC can include a soft catheter tube having an introducing aperture that opens into a primary lumen of the RICC. The introducer can include an introducer catheter including a hard catheter tube having an introducing hole that opens into a single lumen of the introducer catheter. When the RICC assembly is in a ready-to-deploy state, the introducer catheter is disposed in the primary lumen of the RICC such that a distal end of the introducer catheter extends past a distal end of the RICC. An introducer needle of the introducer can be disposed in the introducer catheter through both the introducing aperture and the introducing hole such that a beveled tip of the introducer needle extends past the distal end of the introducer catheter.
An angled intraosseous access system includes a guide assembly including a guide block and a guide plate. The system can include a driver and a needle assembly rotatably coupled thereto. The guide assembly is configured to align the needle at a predetermined angle relative to the medullary cavity. Advantageously, the angled needle of the intraosseous access system can mitigate pain during infusion and mitigate backwalling.
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
77.
Continuous Fiber Optic Functionality Monitoring and Self-Diagnostic Reporting System
A system, apparatus and method directed to detecting damage to an optical fiber of a medical device. The optical fiber includes one or more core fibers each including a plurality of sensors configured to (i) reflect a light signal based on received incident light, and (ii) alter the reflected light signal for use in determining a physical state of the multi-core optical fiber. The system also includes a console having non-transitory computer-readable medium storing logic that, when executed, causes operations of providing a broadband incident light signal to the multi-core optical fiber, receiving reflected light signals, receiving reflected light signals of different spectral widths of the broadband incident light by one or more of the plurality of sensors, identifying at least one unexpected spectral width or a lack of an expected spectral width, and determining the damage has occurred to the optical fiber based on the identification.
A method of inserting a catheter into a vasculature of a patient can include disposing the catheter into a housing. The housing can include a blood flash indicator, having a syringe plunger fixed to the housing and a syringe barrel slidable relative to the syringe plunger. The method can further include positioning the housing adjacent the vasculature, inserting a needle into the housing and through a lumen of the catheter until a distal tip of the needle extends from a distal end of the catheter, and accessing the vasculature via the distal tip of the needle. The method can further include sliding the syringe barrel in a proximal direction relative to the syringe plunger to create a vacuum in a lumen of the needle to thereby draw blood through the lumen of the needle and into the syringe barrel.
An access needle system includes a body defining a bottom surface configured to engage a skin surface of a patient, a needle hub releasably coupled to the body, the needle hub supporting a transversely extending needle, and a left and right wing hingedly coupled to the needle hub. The left wing can include a left main hinge configured to pivot the left wing between a vertical position and a horizontal position, and a left sub-hinge configured to pivot a left outer leaf relative to a left inner leaf from an aligned position to a folded position. The right wing can include a right main hinge configured to pivot the right wing between a vertical position and a horizontal position, and a right sub-hinge configured to pivot a right outer leaf relative to a right inner leaf from an aligned position to a folded position.
A magnetizing method includes obtaining a tray having a needle in the tray, the tray including a first key feature and placing a magnetizer under the tray, the magnetizer including a second key feature. The method further includes aligning the first key feature of the tray with the second key feature of the magnetizer and positioning the tray on the magnetizer with the first key feature and the second key feature aligned. The method further includes magnetizing the needle with the tray inserted into the magnetizer.
A61B 34/20 - Surgical navigation systemsDevices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
81.
Ultrasound Probe with Pressure Measurement Capability
Ultrasound probes, ultrasound systems, and ultrasound methods with pressure measurement capabilities for detecting and determining if bodily tissue is over-compressed during ultrasound imaging procedure. An ultrasound probe can include a probe body, an articulating probe head attached to the probe body, and a pressure-sensing device housed in an articulating area between the articulating probe head and the probe body. A method can include placing the articulating probe head of the ultrasound probe on a skin surface of a patient and moving the articulating probe head of the ultrasound probe over the patient while ultrasound signals are emitted into the patient from the articulating probe head. The method can also include monitoring for measured pressure values induced on the patient by the articulating probe head to determine whether a threshold pressure value has been exceeded.
Portable ultrasound systems and methods, the portable ultrasound system can include a case holding a handheld computer, a probe head coupled to the case, and a needle guide. The handheld computer can include a display. The case can include a posterior opening configured to align with a camera of the handheld computer and an anterior opening configured to align with a display of the handheld computer. The case can include a rechargeable battery integrated into the case opposite the anterior opening. The probe head can include an array of ultrasonic transducers. The needle guide can be coupled to a needle guide holder included with the probe head.
A method of imparting a magnetic signature includes inserting a first medical device into a single-dipole section of a magnetizer and positioning a second medical device into a multipole section of the magnetizer. Inserting the first medical device into the single-dipole section can impart a single-dipole magnetic signature with a first magnetic field to the first medical device. Positioning the second medical device into the multipole section can impart a multipole magnetic signature with a second magnetic field to the second medical device.
An intraosseous access device can include a constant-torque spring assembly disposed in a housing, a drive shaft extending from the housing, and an intraosseous needle coupled to the drive shaft configured to provide intraosseous access to a medullary cavity of a patient. A method of using an intraosseous access device can include inserting a distal end of the intraosseous needle through skin at an insertion site of a patient and applying a contacting force to a bone beneath the insertion site with the distal end of the intraosseous needle. The contacting force can initiate a winding of a ribbon of the constant-torque spring assembly from an output spool onto a storage spool, thereby initiating drilling rotation of the intraosseous needle. The method can further include drilling through the bone until the intraosseous needle enters a medullary cavity of the patient.
A medical device operating as a stylet is described. The medical device can include an insulating layer (or sheath) encapsulating both a multi-core optical fiber and a conductive medium. The optical fiber can include a cladding and a plurality of core fibers spatially arranged within the cladding. Each of the core fibers can include a plurality of sensors distributed along a longitudinal length of that corresponding core fiber and each of these sensors can be configured to: (i) reflect a light signal of a different spectral width based on received incident light, and (ii) change a characteristic of the reflected light signal for use in determining a physical state of the multi-core optical fiber. The conductive medium can provide a pathway for electrical signals detected at a distal portion of the conductive medium. The conductive medium may be concentric to the cladding, but separate and adjust thereto.
G02B 6/12 - Light guidesStructural details of arrangements comprising light guides and other optical elements, e.g. couplings of the optical waveguide type of the integrated circuit kind
G02B 6/42 - Coupling light guides with opto-electronic elements
A system, apparatus and method directed to placing a medical instrument in a patient body, where the system includes the medical instrument having a first optical fiber, a console and an interconnect having a second optical fiber to receive incident light from the console and propagate the incident light to the medical instrument. The interconnect includes a predetermined bend along its length, such that logic of the console may determine a positioning and an orientation of the medical instrument relative to the predetermined bend. Additionally, the logic may generate a display of the medical instrument based on the reflected light signals and the determination of the positioning and the orientation of the medical instrument relative to the predetermined bend, where the display may be rendered as an overlay on an ultrasound image.
A61B 34/00 - Computer-aided surgeryManipulators or robots specially adapted for use in surgery
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
A magnetizer system for use with a medical device including ferrous elements. The magnetizer can include a magnetizer body defining a cavity, the magnetizer body having a body opening in communication with the cavity, the magnetizer body including one or more magnets configured to generate a magnetic field configured to imprint a magnetic signature on ferrous elements within the cavity. The magnetizer can include one or more mechanisms configured to detect the presence of the medical device.
A catheter placement system includes a location sensor configured for placement on a patient, a drape configured to cover the patient and the location sensor, and a connector tethered to a stylet. The location sensor can include an exterior channel having a channel length, an exterior alignment notch positioned above the exterior channel, the exterior alignment notch having a notch length less than the channel length, and an interior receptacle including an electrical contact. The connector can include an alignment protrusion and a piercing element having an electrical contact, the connector configured to couple to the location sensor through the drape. The alignment protrusion of the connector can be configured to move through the exterior alignment notch and into the exterior channel. The piercing element can be configured to pierce the drape and form an electrical connection with the electrical contact in the interior receptacle.
A61M 25/01 - Introducing, guiding, advancing, emplacing or holding catheters
H01R 4/2406 - Connections using contact members penetrating or cutting insulation or cable strands the contact members having teeth, prongs, pins or needles penetrating the insulation having needles or pins
H01R 13/04 - Pins or blades for co-operation with sockets
H01R 13/631 - Additional means for facilitating engagement or disengagement of coupling parts, e.g. aligning or guiding means, levers, gas pressure for engagement only
H01R 13/717 - Structural association with built-in electrical component with built-in light source
89.
Ultrasound system with target and medical instrument awareness
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.
Disclosed herein is a system, apparatus and method directed to placing a medical instrument in a vasculature of a patient body, where the medical instrument includes an optical fiber having one or more core fibers. The system also includes 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, processing the reflected light signals associated with the optical fiber and determining a location of a distal tip of the medical instrument within the patient body. The medical instrument may be steerable in one of various methods including having a predetermined curvature, a distal tip that is magnetic, magnetized, metallic or ferrous and is steerable by an external magnetic device or a having a variable stiffness at a distal tip.
A61B 5/06 - Devices, other than using radiation, for detecting or locating foreign bodies
A61B 1/00 - Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopesIlluminating arrangements therefor
A61B 1/05 - Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopesIlluminating arrangements therefor combined with photographic or television appliances characterised by the image sensor, e.g. camera, being in the distal end portion
A61B 1/07 - Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopesIlluminating arrangements therefor with illuminating arrangements using light-conductive means, e.g. optical fibres
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
Medical device systems including an elongate medical device having a proximal end including one or more sensor connectors, a distal end including one or more sensors or emitters communicatively coupled to the one or more sensor connectors, and a quick-release drive connector including one or more sensor connector attachments configured to detachably couple to the one or more sensor connectors. The one or more sensor connector attachments can be configured to drive the one or more sensors or emitters of the elongate medical device.
A61B 8/12 - Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
92.
Ultrasound Imaging System for Generation of a Three-Dimensional Ultrasound Image
An ultrasound imaging system configured to generate a three-dimensional (3D) ultrasound image of a target area. The ultrasound imaging system includes a console including one or more processors and non-transitory computer readable medium having stored thereon one or more logic modules, and an ultrasound probe configured to acquire a plurality of ultrasound images of a target area. The ultrasound probe can be coupled to the console by an ultrasound probe connector having optical fiber including one or more core fibers. The console is configured to generate the 3D ultrasound image by stitching together the plurality of ultrasound images, starting from a point of reference. The point of reference can be the ultrasound probe, one or more anatomical targets, an elongate medical device, a reference magnet, or one or more accelerometers.
A magnetic signature imprinting system includes an imprinting device and a medical device including ferrous elements. The imprinting device can include an active area having a magnet moving system, one or more sensors, and a console. The magnet moving system can be configured to change the location or orientation of one or more magnets to generate one or more magnetic fields to imprint a magnetic signature. The one or more sensors are configured to detect one or more characteristics of the medical device, and the console can be in communication with the magnet moving system and the one or more sensors.
H01F 13/00 - Apparatus or processes for magnetising or demagnetising
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
A safety mechanism for an obturator having a sharp distal tip and a notch proximal to the sharp distal tip. The safety mechanism includes a sheath and clip combination configured to releasably couple to a needle hub. The clip is configured to transition between a coupled configuration and an uncoupled configuration. The clip can include a first arm including a first keyhole aperture and a second arm including a second keyhole aperture. The clip can further include a biasing member connecting the first arm to the second arm, the biasing member configured to bias the clip toward the uncoupled configuration. The first keyhole aperture and the second keyhole aperture are configured to slidingly receive the obturator. The clip can transition from the coupled configuration to the uncoupled configuration when the first keyhole aperture and the second keyhole aperture engage the notch.
Therapeutic systems and methods for medical treatment use magnetoresponsive materials and structures. For example, a therapeutic system can include an elongate medical device and a magnetic-field generator. The elongate medical device can include a luminal coating, an abluminal coating, or both over at least a distal portion of the elongate medical device. Such a coating can include one or more magnetoresponsive submicron materials responsive to a magnetic field generated by the magnetic-field generator. When the magnetic field is directed toward the coating, the medical treatment can be administered. The medical treatment can be selected from local hypothermia, targeted delivery of one or more therapeutic agents, and combinations thereof for disrupting any thrombotic or non-thrombotic occlusions on the elongate medical device or another elongate medical device. Alternatives to the coating can include formation of the distal portion of the elongate medical device with a magnetoelastic material or magnetoresponsive structure thereon.
A magnetic-based tracking system for tracking an ultrasound probe. The tracking system can create a three-dimensional visualization. The tracking system can include a reference device including a reference magnet and an ultrasound probe including an ultrasound acoustic transducer or acoustic array that acquires ultrasound images. The reference device can include a magnetometer that detects a magnetic field generated by the reference magnet. The ultrasound probe can couple a first ultrasound image with a first magnetic field strength, wherein both of the first ultrasound image is received and the first magnetic field strength is detected at a first time. The system can include a console including a processor and non-transitory computer-readable medium having stored thereon a plurality of processor executed logic modules that perform operations including receiving and recording a plurality of coupling of ultrasound images and detected magnetic field strengths to generate a 3D visualization from the ultrasound images.
A61B 8/12 - Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
A61B 34/20 - Surgical navigation systemsDevices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
Push activated intraosseous (IO) access devices include power sources such as battery packs or spring driven devices. Intraosseous access devices often require training to ensure correct placement of the access device. The disclosed devices include an intuitive operation with a unidirectional activation and drive force application. The trigger can be both activated and deactivated automatically to prevent premature activation and prevent “backwalling”. The device can include various indicators to further guide a user in placing the device correctly, with little or no training. Devices can further include replaceable battery packs to ensure a full charge is available when the device is used, and to provide a multi-use device that requires less storage.
A61B 17/00 - Surgical instruments, devices or methods
A61B 17/16 - Instruments for performing osteoclasisDrills or chisels for bonesTrepans
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
An intraosseous system and methods for accessing a medullary cavity. The intraosseous system can include an access assembly and an advancement assembly. The access assembly can include an obturator assembly coupled to a needle assembly. The advancement assembly can include a housing having an inner wall and a drive screw coupled to an energy source. The drive screw can include a threaded portion extending from a drive screw head. The threaded portion can extend into the housing. The advancement assembly can further include an advancement nut threadably engaged with the threaded portion of the drive screw. The advancement nut can include an outer surface configured to slide along the inner wall a predetermined distance without rotating. The advancement assembly can further include a socket configured for attachment to the access assembly.
A61B 17/16 - Instruments for performing osteoclasisDrills or chisels for bonesTrepans
A61B 17/00 - Surgical instruments, devices or methods
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
Guidewire-management devices and systems. The guidewire-management device can include a guidewire, a first sleeve, and a second sleeve. The first sleeve can be configured for distally feeding the guidewire out of the guidewire-management device. The first sleeve can also be configured for proximally feeding the guidewire into the guidewire-management device. The second sleeve can be proximal of the first sleeve in the guidewire-management device. The second sleeve can be configured for feeding the guidewire in concert with the first sleeve. At least a length of the guidewire extending between the first sleeve and the second sleeve can be disposed within a sterile barrier configured to maintain sterility of the guidewire.
Guidewire-management devices including a guidewire, a first sleeve, and a second sleeve. The first sleeve can be configured for distally feeding the guidewire out of the guidewire-management device. The first sleeve can also be configured for proximally feeding the guidewire into the guidewire-management device. The second sleeve can be proximal of the first sleeve in the guidewire-management device. The second sleeve can be configured for feeding the guidewire in concert with the first sleeve. At least a length of the guidewire extending between the first sleeve and the second sleeve can be disposed within a sterile barrier configured to maintain sterility of the guidewire.
