Procedural barrier-breaching connectors and connection-establishing devices, and systems and methods thereof, for establishing portals in procedural barriers are disclosed. For example, a connection-establishing device can include a cap and an extension arm. The cap is configured to sit over a protruding portion of a first medical device with a procedural barrier between the connection-establishing device and the first medical device. The extension arm is configured to push a male connector of a second medical device through the procedural barrier and into a female connector of the first medical device with the extension arm, which establishes one or more functional connections across the procedural barrier between the second medical device and the first medical device. An exemplary method for the connection-establishing device includes a cap-placing step, an articulating step, and a functional connection-establishing step for establishing the one-or-more functional connections.
Methods for transferring a graphene-metal bilayer to form a laminate. The method can include selectively etching a first continuous polymer layer with a first etchant through a first discontinuous polymer layer, thereby removing a first sacrificial layer of the first continuous polymer layer and the first discontinuous polymer layer and exposing a face of a graphene layer a graphene-metal bilayer. The method can further include laminating the substrate by pressing the face of the graphene layer into a surface of the substrate. The method can further include selectively etching a second continuous polymer layer with a second etchant through a second discontinuous polymer layer, thereby removing a second sacrificial layer of the second continuous polymer layer and the second discontinuous polymer layer, exposing a face of a metal layer of the graphene-metal bilayer, and transferring the graphene-metal bilayer to the substrate.
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 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.
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
16.
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.
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
19.
Medical-Device Navigation Systems and Methods 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 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
23.
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
25.
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.
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
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 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.
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
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
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 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
38.
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.
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
40.
RFID Enabled Medical Devices and Associated Systems
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
41.
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.
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 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 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
46.
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.
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
49.
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.
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
52.
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
60.
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
63.
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.
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.
An ultrasound imaging system includes an ultrasound probe configured to acquire ultrasound images, a processor, and a non-transitory computer-readable medium having stored thereon logic that, when executed by one or more processors, cause the one or more processors to perform operations including receiving ultrasound imaging data from the ultrasound images, identifying a blood vessel from the ultrasound imaging data, tracking a position of a needle tip with respect to the blood vessel, and generating an alert if the blood vessel is an artery and the needle tip is within a perimeter threshold of the artery.
Apparatus and methods of manufacture for an intraosseous assembly. The intraosseous assembly includes a flexible obturator with relatively low columnar strength, relatively low shear strength, and/or relatively high compressive strength. When the flexible obturator is supported in a needle of the intraosseous assembly, it can prevent bone fragments and tissue from blocking the needle lumen. When removed from the needle, the flexible obturator can deform under a force to prevent accidental needle stick injuries. The flexible obturator can define a radially symmetrical profile and can conform to the inner profile of the needle lumen. The flexible obturator can extend beyond a distal tip of the needle and be trimmed flush to a beveled surface of the needle. This simplifies the manufacturing process, allowing a single size obturator to be fitted to multiple sizes of needle.
Rapidly insertable central catheters (“RICCs”) including catheter assemblies and methods thereof are disclosed. A RICC assembly can include a RICC, an introducer, and a coupling system configured to couple the RICC and the introducer together. A catheter tube of the RICC includes a side aperture in a distal-end portion of the catheter tube, which opens into an introducing lumen extending to a distal end of the RICC. The introducer includes an introducer needle extending through the distal end of the RICC when the RICC assembly is in at least a ready-to-deploy state thereof. The introducer is configured to be actuated with a single finger of a hand while holding a distal-end portion of the introducer between a thumb and another finger or fingers of the hand. The coupling system includes a distal coupler slidably attached to the catheter tube proximal of the side aperture.
A self-disinfecting system can include a cladding having a flexible body that conforms to a substrate. The system can further include a disinfection means for disinfecting an exterior surface of the cladding. The disinfection means can be selected from a germicidal irradiation means, a photocatalytic disinfection means, or a chemical disinfection means for disinfecting the exterior surface of the cladding. The germicidal irradiation means can employ germicidal radiation from one or more locations within the body or the substrate to disinfect the cladding. The photocatalytic disinfection means can employ excitation radiation to produce reactive oxygen species using a photosensitizer incorporated into one or more polymeric layers of the body or a coating thereover to disinfect the cladding. The chemical disinfection means can employ a chemical disinfectant incorporated into the one-or-more polymeric layers of the body to disinfect the cladding.
A medical device-placing system including a medical-device tip-location sensor (“TLS”) configured for placement on a chest of a patient, an ultrasound probe, a console, and an alternative-reality headset. The ultrasound probe can be configured to emit ultrasound signals into the patient and receive echoed ultrasound signals from the patient. The console can be configured to transform the echoed ultrasound signals to produce ultrasound-image segments corresponding to anatomical structures of the patient, as well as transform TLS signals from the TLS into location information for a medical device within the patient. The alternative-reality headset can include a display screen through which a wearer of the alternative-reality headset can see the patient. The display screen can be configured to display over the patient a virtual medical per the location information for the medical device within objects of virtual anatomy corresponding to the ultrasound-image segments.
Rapidly insertable central catheters (“RICCs”), RICC assemblies, and methods thereof. A RICC can include a catheter tube, a suture wing disposed over a medial portion of the catheter tube, a hub coupled to a proximal portion of the catheter tube, and a number of extension legs extending from the hub. The catheter tube can include a first section in a distal portion of the catheter tube and a second section proximal of the first section. The suture wing can include a projection opposite a patient-facing side of the suture wing and a needle through hole through the projection. The needle through hole can be configured to accept a needle therethrough for insertion of the needle into a primary lumen of the catheter tube, which passes through a catheter-tube through hole through the suture wing.
A placement system for tracking, placing, and monitoring a catheter assembly or other medical device inserted into a body of a patient is disclosed. The placement system utilizes optical fiber-based strain sensors to assist with catheter placement. In one embodiment, the placement system comprises a console including a processor and a plurality of optical fiber-based strain sensors included with the catheter. A light source is also included and configured to operably connect with the strain sensors and produce outgoing optical signals incident on the strain sensors. A photodetector is included and configured to operably connect with the strain sensors and receive return optical signals from the strain sensors. A processor is configured to process data from the return optical signals. The data relates to an aspect of the catheter. A user interface such as a display is configured to communicate information relating to the aspect of the catheter.
G01L 5/161 - Apparatus for, or methods of, measuring force, work, mechanical power, or torque, specially adapted for specific purposes for measuring several components of force using variations in ohmic resistance
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61M 25/01 - Introducing, guiding, advancing, emplacing or holding catheters
G01L 1/24 - Measuring force or stress, in general by measuring variations of optical properties of material when it is stressed, e.g. by photoelastic stress analysis
Disclosed herein is an ultrasound system for accessing a vasculature of a patient. The ultrasound system is configured to depict an enhanced ultrasound image of a subcutaneous portion of the patient including an icon surrounding a target vessel depicted on the display. The icon indicates to a clinician the target vessel is within range of a percentage vessel occupancy or vessel purchase length depending on a size of cannula or angle of insertion. The icon can also indicate blood flow strength, vessel type, or vessel deformation. The enhanced image can further include cannula trajectory guidelines and visual alerts for the clinician if the cannula tip can potentially backwall the vessel. Additional icons can indicate obstructions disposed on the cannula trajectory.
An ultrasound probe for sustained spatial attention. The ultrasound probe can include a display screen on a visible side of the ultrasound probe, the display screen coupled to ultrasound imaging components in the ultrasound probe, the ultrasound imaging components configured to capture live subcutaneous images and render the live subcutaneous images on the display screen. The ultrasound probe can further include one or more needle trajectories depicted on the display over the live subcutaneous images, the one or more needle trajectories configured to assist a user in guided insertion of a needle into an anatomical target under the ultrasound probe. The ultrasound probe can further include a light-pattern projector on the visible side of the ultrasound probe adjacent the display screen, the light-pattern projector configured to project a light pattern corresponding to a subcutaneous depth accessible by a needle.
A vascular access device (VAD) monitoring system includes a VAD with a catheter tube that is subcutaneously disposed and incorporates a fluorescent dye. An optical imaging system is also provided, comprising a light source emitting infrared (IR) excitation light and a camera capable of detecting signal light emitted by the fluorescent dye upon exposure to the excitation light. This enables real-time monitoring of the VAD, allowing for the detection of any potential complications or issues related to the vascular access device. The combination of the catheter tube with the fluorescent dye and the optical imaging system provides a non-invasive and efficient means of monitoring the VAD, enhancing patient safety and improving overall healthcare outcomes.
Microcirculation assessment systems and methods for determining a systemic response of a patient which may be related to sepsis. A microcirculation assessment device coupled with a patient obtains a microcirculation assessment of the patient. System logic applies an algorithm to the microcirculation assessment to indirectly determine the systemic response. Artificial intelligence and/or machine learning logic collects microcirculation assessment data and corresponding actual systemic responses to define the algorithm that correlates microcirculation assessment with systemic response. System logic may recommend a therapy based the systemic response. System logic may also govern the operation of therapy equipment to deliver a therapy. The microcirculation assessment device may utilize any suitable technology to obtain the microcirculation assessment, such as ultrasound, video capillaroscopy, or thermal imaging, for example. The microcirculation assessment device may be a wearable device or incorporated into hospital bed. Therapy may include body temperature modulation, oxygenation, or infusate delivery.
An ultrasound probe includes a light source configured to project a visual indication onto a skin surface of the patient. The visual indication includes different visual characteristics that are based on characteristics of the anatomical target such as a location with respect to the probe and/or an identification of an anatomical target as a vein or as an anatomical element other than a vein, such as an artery. Visual characteristics include shapes, locations, and/or colors of the projected visual indication. Logic of the probe performs location and/or identification processes on ultrasound image data that may include applying trained machine-learning models to the ultrasound image data. Some embodiments, include a virtual/augmented reality headset and/or a needle tracking system. An ultrasound system includes machine-learning logic that generates the trained machine-learning models from historical ultrasound image data sets and actual anatomical target location/identification data sets.
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
84.
Shape-Sensing Systems with Filters and Methods Thereof
A shape-sensing system can include a stylet, an optical interrogator, a console, and a display screen. The stylet can include an optical fiber with fiber Bragg grating (“FBG”) sensors along a length of the optical fiber. The optical interrogator can be configured to send input optical signals into the optical fiber and receive FBG sensor-reflected optical signals from the optical fiber. The console can be configured to convert the reflected optical signals with the aid of filtering algorithms of some optical signal-converter algorithms into plottable data for displaying plots thereof on the display screen. The plots can include a plot of curvature vs. time for each FBG sensor of a selection of the FBG sensors for identifying a distinctive change in strain of the optical fiber as the stylet is advanced into a superior vena cava of a patient.
A vasculature assessment device includes an imaging probe configured to acquire raw image data of a blood vessel of a patient and a device module having a console coupled with the imaging probe. Logic stored in memory device module determines blood vessel data from the raw image data and applies a trained machine learning model to the blood vessel data to determine suggested catheter parameters for catheter to be inserted within the blood vessel. A vasculature assessment system includes a plurality of the vasculature assessment devices and a computing system coupled with the vasculature assessment devices. Machine learning logic of the computing system performs a machine learning algorithm on historical catheter placement data sets to define the trained machine learning model.
A61B 8/00 - Diagnosis using ultrasonic, sonic or infrasonic waves
A61B 8/12 - Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
G16H 10/60 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
A medical ultrasound system and methods of using the system. The medical ultrasound system can include an ultrasound probe and one of a plurality of optional accessories attached to the ultrasound probe. The accessory can exchange data with the probe and receive power from the probe. The accessory can include processors and logic that governs its operation thereby adding functionality to the probe. The accessory can receive input and provide output via any of a number of communication mechanisms, i.e., wireless, electrical, optical, RFID, IR, and the like. The accessory can add functionality to the probe, such as fiber optic shape sensing, obtaining electrical signals, obtaining bio-impedance measurements, tracking a needle, and determining the orientation of the probe. The accessory may include a needle guide, a triphalangeal support structure, or an acoustically transparent cap.
A blood vessel detection device includes a pair of light sources that project lights having different wavelengths through the skin into a detection area of a patient and a photodetector that receives reflected lights originating from the light sources. Logic of a microcontroller of the device processes the intensity data related to the reflected lights having the different wavelengths to determine the presence of a blood vessel within the detection area and/or the identity of the blood vessel as a vein or an artery. The wavelengths are chosen such that hemoglobin within a blood vessel reduces the reflected light intensity different amounts according to an oxygen content of the hemoglobin. The intensities of one or both reflected lights is used to detect the presence of a blood vessel and a difference or a ratio of the intensities is used to identify the blood vessel as a vein vs an artery.
An apparatus and method for a stepped needle for an intraosseous device that uses the outer surface of the bone cortex as a reference point. Since the thickness of the bone cortex does not vary significantly between patients, the accuracy of needle placement can be improved. The device includes a needle with a stepped increase in outer diameter disposed along the needle shaft. The abrupt change in outer diameter provides a substantial increase in insertion force. The stepped increase prevents any further insertion into the bone cortex. Embodiments can include a tapered needle lumen for medullary access confirmation and an overtube that is rotatably and slidably engaged to protect surrounding tissues and prevent needle stick injuries. Further, a needle hub can be rotatable or slidable, and can transition an overtube to an extended position to prevent accidental needle stick injuries.
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
89.
Fiber Optic Medical Systems and Devices with Atraumatic Tip
Medical systems and devices include an elongate probe configured for insertion into a patient, where the elongate probe includes an atraumatic tip and where the atraumatic tip can include one or more of a loop, a curl, coil, a flexible distal region, and a steerable distal region. The distal region can be configured to transition away from a first shape toward a second shape upon insertion of the elongate probe within the patient. The optical fiber can include sensing core fibers configured to facilitate a determination of a physical state of the elongate probe. The elongate probe can also be configured to project illuminating light away from a distal end and receive imaging light at the distal end. The elongate probe can include 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 1/07 - 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
An antimicrobial catheter can include one or more polymeric inserts of a filled polymer in a catheter tube, a catheter hub, one or more extension legs, one or more extension-leg fittings or a combination thereof. Each polymeric insert of the one-or-more polymeric inserts can provide a portion of a luminal surface in a catheter component selected from the catheter tube, the catheter hub, the one-or-more extension legs, and the one-or-more extension-leg fittings. Further, each polymeric insert of the one-or-more polymeric inserts can elute one or more antimicrobial metal species therefrom upon contact with a liquid. A method of making such an antimicrobial catheter can include a polymeric insert-molding operation of molding a plurality of the polymeric inserts as well as a catheter component-molding operation of molding a plurality of at least one catheter component selected from the catheter tube, the catheter hub, an extension leg, and an extension-leg fitting.
A system and method for determining a difficult venous access of a patient. Logic processes meta data acquired by a vasculature assessment device coupled with the patient. The meta data, e.g., vessel diameter, vessel depth, vessel wall thickness, vessel wall elasticity, tissue elasticity, tissue profusion, blood flow rate, or hydration level. The logic further determines a difficult venous access by performing an algorithm on the meta data. The algorithm is defined utilizing machine learning techniques applied to an ongoing collection data sets acquired from a plurality of systems across a plurality of patients undergoing catheter insertion events. The data set may also include patient data such as weight, age, etc. The vasculature assessment device may include ultrasound imaging, infrared imaging, molecular imaging, Raman spectroscopy, or optical coherence tomography to acquire one or both of three-dimensional imaging data and the meta data.
A catheter assembly can include a catheter, a controller, and an internal power source. The catheter can include a catheter tube and a catheter hub, wherein a proximal-end portion of the catheter tube can be disposed in the catheter hub. The catheter tube can incorporate a plurality of piezoelectric transducers into a length of the catheter tube. The plurality of piezoelectric transducers can be configured as a plurality of vibrators for vibrating and, thereby, inhibiting buildup of biomaterial on a luminal or abluminal surface of the catheter tube by way of vibrations along the length of the catheter tube when the catheter tube is placed in a vasculature. The controller can include a processor and memory, wherein the controller can be configured to control at least the plurality of piezoelectric transducers. The internal power source can be configured to power the controller and the plurality of piezoelectric transducers.
An insertion tool for inserting a catheter into a patient's body is disclosed. The insertion tool unifies needle insertion, guidewire advancement, and catheter insertion in a single device. In one embodiment, the insertion tool comprises a housing in which at least a portion of the catheter is initially disposed, a hollow needle distally extending from the housing with at least a portion of the catheter pre-disposed over the needle, and a guidewire pre-disposed within the needle. A guidewire advancement assembly is also included for selectively advancing the guidewire distally past a distal end of the needle in preparation for distal advancement of the catheter. A catheter advancement assembly is also included for selectively advancing the catheter into the patient. The catheter advancement assembly includes a mechanical advantage mechanism coupled between the slide of the insertion tool and the catheter.
A system, apparatus and method directed to placing a medical instrument in a vasculature of a patient body, the system including an optical fiber with one or more core fibers. The system can include a console having non-transitory computer-readable medium storing logic that, when executed, causes operations of providing an incident light signal to the optical fiber, receiving a reflected light signal of the incident light, wherein the reflected light signal is reflected from at least one of red blood cells or tissue within the patient body, processing the reflected light signal to determine an oxygen level within the patient body near a distal tip of the optical fiber. The method can include determining a location of the distal tip of the optical fiber within the patient body at least based on the oxygen level.
Devices, systems, and methods for minimizing or preventing contamination of sterile medical devices during magnetization. A magnetizer cover can be used to maintain sterility of a medical device while magnetizing the medical device. The magnetizer cover can include a base and a protective portion. The magnetizer cover can also include a grip tab extending from the base. The protective portion can include a funnel and a funnel stem to protect a magnetizable portion of the medical device from contacting the magnetizer.
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
A61B 8/00 - Diagnosis using ultrasonic, sonic or infrasonic waves
A61B 17/00 - Surgical instruments, devices or methods
A system, apparatus and method are directed to a magnetizer comprising at least one magnetizing element and an irradiation source. The housing defines a cavity that communicates with an opening. By placing a medical device, e.g. a needle, through the opening and into the cavity exposes the needle to the irradiation source while being magnetized to imprint a magnetic signature. Optionally, a switching mechanism can be actuated when the needle passes through/engages the opening and actuates the irradiation source and/or magnetizing element. Advantageously, the needle can be sterilized while being magnetized. Further, the cavity can be sterilized to prevent contaminating the needle during magnetization.
Catheter placement assemblies having automatic guidewire disengagement can include a handle and seal housing assembly defining a needle lumen and guidewire lumen. Once the vasculature is accessed, the guidewire advances through the handle guidewire lumen to a target location. The needle is withdrawn proximally through the handle needle lumen with a first force. When the needle tip is withdrawn into the seal housing, the seal housing locks to the needle tip. Applying a second, greater force urges the seal housing to disengage the handle. The seal housing is retained in place by a detent and/or timing lock mechanism. As the seal housing is urged proximally, a support pin retains the guidewire in place causing the guidewire to automatically disengage the seal housing. The seal housing mitigates needle stick injuries and allows the needle and seal housing assembly to be removed, allowing for unobstructed advancement of the catheter over the guidewire.
Connection systems and methods for establishing optical and electrical connections through a drape are disclosed. A connection system can include a plug and a receptacle, the plug being configured to insert into the receptacle with the drape therebetween. The plug can include an optical terminal extending from a plug housing and an electrical terminal extending from the plug housing. The electrical terminal can be configured as a piercing element for piercing the drape. The receptacle can include an optical receiver within a receptacle housing and an electrical receiver within the receptacle housing. The optical receiver can be configured to form the optical connection with the optical terminal, and the electrical receiver can be configured to form the electrical connection with the electrical terminal when the plug is inserted into the receptacle with the drape therebetween.
A triphalangeal stabilization feature for an ultrasound probe includes a stationary member, a manipulation member, and a locking member. The stationary member has a shape conforming to an outer surface of the ultrasound probe. The manipulation member is slidingly coupled to the stationary member and extends away from the stationary member to provide a surface for one or more of a user's fingers. The locking member is configured to prevent movement of the manipulation member with respect to the stationary member at one or more different positions along the stationary member.
A system and method for monitoring sepsis in a patient. Logic processes ultrasound image data acquired by one or more pads applied to the patient. The logic determines vascular parameters values, such as blood vessel size or shape, and the logic further determines a sepsis status and/or progression from the vascular parameter values by performing an algorithm on the vascular parameter values. The algorithm is defined utilizing artificial intelligence techniques applied to an ongoing collection data sets acquired from a plurality of sepsis monitoring systems across a plurality of patients undergoing sepsis events, where each data set includes one or more vascular parameter values and a corresponding independently acquired sepsis status for the sepsis event. The data set may also include patient data such as weight, age, etc. The pads may be wirelessly coupled with a system module. The vascular parameters may include multiple vascular sites on the patient.
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