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 catheter placement system for placing a catheter, the system including a stylet with an optical fiber (135) extending therethrough, a stylet body (290) extending between a proximal end and a distal tip (290). A console (20), equipped with optical logic, delivers broadband incidence light to the optical fiber and receives reflected light signals to determine positional information about the stylet body. The stylet body is configured to be separable at a point between the proximal end and distal tip to allow a catheter to be advanced over a distal portion of the stylet body. The distal portion is configured to be reattached to the proximal portion to reconfirm the position of the stylet body distal tip prior to removal of the stylet from the catheter. The system further includes a severing device that is easy to actuate and ensures a clean, perpendicular cut to facilitate reconnection between the proximal and distal portions.
An intrauterine device (IUD) may include a magnetic field source and/or a shape sensing optical fiber that enables positional tracking of the IUD during placement. An insertion device (ID) for the IUD may also include a magnetic field source and/or a shape sensing optical fiber. An IUD placement system includes logic that processes magnetic field sensing data and/or optical shape sensing data to determine a real-time position and/or an orientation of the IUD or the ID with respect to the uterus during placement of the IUD. Logic may render, on a display, visual representations of the uterus and/or ultrasound images of the uterus obtained by an ultrasound probe of the system. Logic further overlays, atop the visual representations of the uterus and/or ultrasound images of the uterus, visual representations of the IUD or the ID at the real-time position and/or orientation.
A tactile-feedback system (104) for a guidewire-containing medical device (100) includes a guidewire (108)and a rigid member (110) in vibratory communication with a handholdable portion (112) of the medical device. The guidewire includes interactive features (118) along its length. The interactive features of the guidewire interact with the rigid member to produce user-perceptible vibrations in the handholdable portion of the medical device as the guidewire moves against the rigid member while being advanced out of the medical device or retracted into the device. The user-perceptible vibrations provide tactile feedback to a user of the medical device indicating a status of the guidewire with respect to a patient or the medical device.
The ultrasound probe cover system comprises a cradle arm supporting an ultrasound probe in a predetermined position, a first applicator arm articulating relative to the cradle arm and housing a sterilizer applicator and a gel applicator for applying a sterilizing agent and a gel to the probe head, and a sheath arm with a sheath holder supporting an open sheath. The sheath arm articulates relative to the cradle arm to position the sheath opening over the probe head. The sheath includes a biasing member extending helically and configured to bias the sheath to an extended configuration to facilitate placing the sheath over the probe. The cover system provides a convenient and efficient solution for covering and preparing ultrasound probes for medical procedures, enhancing hygiene and usability in healthcare settings.
A medical-device visualization system includes an elongate medical device having passive electromagnetoresponsive ("EMR") elements distributed along a length thereof, a magnetic interrogator having magnetic transducers for transducing responses of the EMR elements to an external magnetic field, and a console for visualizing a shape of the medical device as it is advanced through a vasculature of a patient within the external magnetic field. A registration process of the console registers the EMR elements including a distalmost EMR element of the medical device at various magnetic transducers. A shape-sensing process senses the shape of the medical device from time-dependent location data for the EMR elements from the magnetic interrogator. A reference-framing process places the shape of the medical device in a patient-based reference frame following conversion of the location data from a magnetic interrogator-based coordinate system to a patient-based coordinate system in the patient-based reference frame.
A medical-device navigation system includes, in some embodiments, an electromagnetoresponsive ("EMR") element, a magnetic interrogator, and a console. The magnetic interrogator generates an external magnetic field, transduces resonance-based responses of the EMR element thereto, and provides response data for the EMR element as an elongate portion of a medical device including the EMR element moves through the external magnetic field. The console instantiates medical-device navigation processes including a data- acquisition process, a triangulation process, and a plotting process for navigating the elongate portion of the medical device as it is advanced through the external magnetic field to a target location. The data-acquisition process acquires the response data from the magnetic interrogator over time, the triangulation process triangulates the EMR element with respect to magnetic sensors of the magnetic interrogator over time, and the plotting process plots a location of the EMR element on a display screen of the console over time.
A tracking and steering system for medical devices comprises a magnetic element attached to a distal portion of the medical device, a sensor on the patient's external surface detecting the magnetic field strength of the medical device's magnetic element, and a steering magnet on the patient's external surface with an electromagnet attracting the medical device's magnetic element. A console with memory and processors receives sensor data to determine the medical device's distal tip position and controls the sensor and steering magnet activation. A display shows an image of the patient with an icon indicating the medical device's location relative to the patient, enhancing medical procedures with real-time tracking and steering capabilities.
Photoacoustic medical-device navigation systems and methods provide alternatives to those incorporating fluoroscopy for medical-device navigation in patient bodies. A medical-device navigation system can include an optical-fiber stylet, ultrasound transducers, and a console. The stylet can transmit light to an instant location of a distal tip of an elongate medical device in a patient's body and, thereby, irradiate endogenous chromophores to generate ultrasound-frequency photoacoustic pressure waves therefrom. The ultrasound transducers can detect ultrasound signals corresponding to the photoacoustic pressure waves. The console can instantiate medical-device navigation processes for navigating the elongate medical device via the stylet as the elongate medical device is advanced to the target location in the patient's body. The medical-device navigation processes can include acquiring ultrasound-signal data from the ultrasound transducers, reconstructing images from the ultrasound-signal data, and displaying reconstructed images on a display for navigating the elongate medical device to the target location in the patient's body.
A system, apparatus and method directed to determining a temperature within a patient body, including an optical fiber with one or more core fibers. The system can include a console having non-transitory computer-readable medium storing logic that, when executed, causes operations of providing an incident light signal to the optical fiber, receiving a reflected light signal of the incident light, processing the reflected light signal to determine a temperature within the patient body near a measurement region. The method may include determining a location of a distal tip of the optical fiber within the patient body at least based on the temperature.
Medical-device visualization systems and methods utilize patient-based reference framing to improve shape sensing for elongate medical devices. A medical-device visualization system includes, in some embodiments, a stylet, patient-wearable sensors, and a console. The stylet includes an optical fiber and a field generator. Each of the patient-wearable sensors senses a field generated by the field generator. The console instantiates medical-device visualization processes for visualizing the elongate medical devices by way of at least the stylet. The medical-device visualization processes include a shape-sensing process, a registration process, and a reference-framing process. The shape-sensing process determines a shape of the stylet in real-time from reflected optical signals from the optical fiber. The registration process registers the distal tip of the stylet in real-time at each sensor of the patient-wearable sensors. And the reference-framing process places the stylet with its shape in a patient-based reference frame established by the patient-wearable sensors.
Catheter clips (110) and catheter insertion assemblies including such catheter clips facilitate sterile catheterization, thereby reducing the risk of catheter-related bloodstream infections. A catheter clip (110) can include a pair of lever arms (142) mated to each other. Each lever arm of the pair of lever arms can be bilaterally asymmetric but identical to the other lever arm of the pair of lever arms. An elastomeric band (150) can be over a jaw end portion of the catheter clip. A catheter retainer (152) can be coupled to a handle end portion of the catheter clip. The catheter retainer can be configured to hold a catheter connector of a catheter such that at least a proximal portion of the catheter remains in a sterile field when the catheter clip is clipped onto a sterile drape that establishes at least a portion of the sterile field.
A medical system module configured to provide instructions to a user includes an input module configured to receive input pertaining to medical procedures to be performed on a patient by a user utilizing the medical system and an output module configured to provide to the user instructions for performing the medical procedures. Logic operations of the system include defining a set of the instructional steps to be followed during a performance of a selected medical procedure. A medical system can include magnetic tracking of a medical device and determining a shape of the medical device optical fiber shape sensing. Logic operations can include Artificial intelligence techniques. Providing user instructions can include pictorial illustrations as well as textual instructions. Pictorial illustrations can include historical image or other visual representations previously recorded and stored in memory. Logic determines completion of instructional steps by comparing a live visual representation with historical visual representations.
An occlusive dressing and medical device system (100) includes a medical device (150) having a hub (160) featuring an occlusive surface (170). The occlusive surface can extend over a plane parallel to a patient's skin surface. A catheter tube (152) can extend through an insertion site in the skin surface and is supported at a proximal end by the hub. An extension leg (158) and/or connector (156) can extend from the occlusive surface. The system also includes a dressing with adhesive to attach to the hub and the skin surface. The dressing can include a fenestration (118) disposed within an outer perimeter of the dressing (116), which receives the extension leg and/ or connector therethrough and an edge of the fenestration engages and adheres to the occlusive surface along the entire circumference of the edge. The engagement between the fenestration and the hub can mitigate the formation of pathogen pathways underneath the dressing to reduce the risk of infection.
An introducer can include an introducer needle (134) and an introducer sheath (136) having a transition therebetween that eases tissue over a distal end of the introducer sheath without catching tissue thereon tissue despite an excised portion of the introducer needle. The introducer needle can include a needle shaft (140) having a longitudinal needle slot (146) extending from a proximal portion of the needle shaft through a distal needle tip (144), which results in an excised portion of a heel of a bevel (150) of the needle tip. The introducer sheath can include a sheath body (162) and a tapered sheath tip (170). The sheath body can be over the needle shaft sealing the needle slot thereunder but for a sheath-body opening (166) in a proximal portion of the sheath body for an access guidewire.
A guidewire (150) having a modified surface to reduce drag force between the outer surface of the guidewire and an inner surface of the catheter lumen (114). Preloaded catheter systems (100) include a guidewire disposed within a lumen of the catheter (110). The guidewire is equal to, or slightly smaller than an inner diameter of the catheter lumen to impart columnar strength to the catheter during placement. However, due to increase contact surface area between the guidewire and the catheter lumen, the guidewire can stick within catheter lumen requiring increase force to slide the guidewire relative to the catheter. Surface modifications on the guidewire can reduce the contact surface are between the guidewire and catheter resulting in a reduced drag force therebetween. A plurality of longitudinal grooves (156), disposed in a regular or irregular pattern, and reduce drag force without affecting the flexible properties of the guidewire.
An intraosseous access system includes an intraosseous driver having socket configured to receive a shaft of an obturator assembly. An O-ring disposed within a groove of the shaft inhibits removal of the shaft from the socket. The O-ring can be compressed within the groove to define a frictional force between the socket and the shaft. The socket can include recesses and the O-ring may expand into the recesses to inhibit removal of the shaft from the socket. The driver can include a latch mechanism configured to selectively prevent removal of the shaft and allow removal of the shaft. An adapter can be positioned between the driver and obturator assembly where the adapter includes the latch mechanism. The latch mechanism include an actuator to selectively transition the latch mechanism between a retaining state and a releasing state.
A clinical bedside system facilitates care for complex care patients. The system can include a medical device having a biosensor with an inert substrate and a working electrode, a counter electrode, and a reference electrode deposited thereon. The working electrode can have an antifouling membrane thereover to which a capture antibody is immobilized. The capture antibody can be configured to capture a biomarker between it and a detection antibody, thereby sandwiching the infection biomarker between the antibodies for a detectable redox reaction between an enzyme conjugated to the detection antibody and the working electrode. The counter electrode can complete completes an electrical circuit including the working electrode. The reference electrode can be operably connected to the electrical circuit. The reference electrode can be configured to provide a reference point against which changes in potential at the working electrode can be measured, for example, with a potentiostat.
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions
G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
19.
SYSTEMS AND METHODS OF SHAPE SENSING MEDICAL DEVICES WITH ELECTROMAGNETORESPONSIVE ELEMENTS
A shape-sensing system includes electromagnetoresponsive elements along a length of an elongate medical device that respond to an external magnetic field generated by a magnetic interrogator. The magnetic interrogator transduces responses of the electromagnetoresponsive elements, thereby collecting location-dependent response data therefrom as they move through the external magnetic field. A console converts the location-dependent response data into raw 3D location data. The console can interpolate the raw 3D location data, thereby generating estimated 3D location data for one or more portions of the medical device between any two electromagnetoresponsive elements to provide plottable 3D location data. The console can further plot the plottable 3D location data on a display screen of the console in real-time as the medical device and the electromagnetoresponsive elements associated therewith move through the external magnetic field, thereby displaying a graphical representation of the medical device per its location, shape, and orientation in 3D space.
Needle-guiding systems and methods can facilitate establishing vascular access with a nonmagnetic needle. For example, a method of a needle-guiding system can include detecting and registering registration marks about a patient by patient-facing cameras of an alternative reality ("AR") device, the AR device thereby establishing its location and orientation relative to a target area of the patient. The method can also include anchoring ultrasound images of the target area as viewed through a display screen of the AR device, the ultrasound images anchored about the patient relative to either an instant or previous location and orientation of the ultrasound probe; and providing an instant virtual needle trajectory of the needle as viewed through the display screen of the AR device, thereby indicating to a clinician whether the needle is properly oriented for establishing vascular access to a target vessel of the ultrasound images.
A medical imaging system including an optical identifier camera for imaging a medical device, a medical device packaging, a patient, or a technician. The system further includes an imaging probe for imaging of a target location, and a console with optical identifier logic to extract identifier markers or characteristics from the image of the medical device, packaging, patient or technician. A parameter logic determines the medical imaging parameters based on the identifiers or characteristics, and a medical imaging logic captures medical images of the medical device. The system enables efficient and accurate imaging of medical devices on the specific patient, by a specific technician, enhancing diagnostic capabilities and treatment planning in medical parameters.
A method of providing sterile medical devices including placing medical devices within a container along with a source of sterilizing gas to define a kit at a kitting facility. Closing the container enables exposure of the medical devices to the sterilizing gas to sterilize the medical devices. The container is opened at a point of use location where the medical devices are removed from the container. The source of sterilizing gas includes a plastic material impregnated with iodine. The medical devices may be selected from a population of received at the kitting facility from one or more medical device companies based on a selected medical procedure. The source of sterilizing gas container and bulk packaging can be reusable. The kit can be provided to the point of use location in a just-in-time fashion.
B01J 20/00 - Solid sorbent compositions or filter aid compositionsSorbents for chromatographyProcesses for preparing, regenerating or reactivating thereof
A needle assembly includes a needle (130) and a needle cap (124) configured to encapsulate a needle tip after use. The needle cap is transitionable between (i) an extended position with respect to the needle cap, where the needle extends through a distal opening of the needle cap such that a distal tip of the needle extends distally beyond the distal end of the needle cap; and (ii) a retracted position with respect to the needle cap, where the distal tip is disposed within the needle cap. An obstructor, rotationally disposed within the needle cap transitions from a non-obstructing state to an obstructing state to prevent the distal tip of the needle from extending distally beyond the distal end of the needle cap in the obstructing state. Tension in a tether extending between a needle hub and the needle cap, enables decoupling of a medical device (114) from the needle cap.
A61M 25/06 - Body-piercing guide needles or the like
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A guidance system for guiding insertion of a medical device toward a target within target area a patient utilizes ultrasound or other suitable technology. The guidance system can include a device guidance module (e.g., an ultrasound probe) for producing target data of the target area. The device guidance module provides sensory feedback including visual, haptic and/or audio feedback based on a determined position of the medical device. One or more sensors detect a magnetic field generated by the medical device. Providing the sensory feedback may include adjusting a variable characteristic of the sensory feedback based on determining a variable position of the medical device. The system may include a processor that can receive magnetic field data sensed by the at-least-one sensor to determine the position of the needle. The system specifically omits depicting an image of a target area of the patient on a display.
A medical system includes an elongate vascular device having an optical fiber and a sensor module configured to detect pressure pulses at the skin surface resulting light pulses projected from a distal tip of the optical fiber within the vasculature of a patient. Logic of a system console processes pressure pulse data using photo-acoustic imaging techniques to obtain an image the vasculature. The processing also can include determining properties of the vasculature, such as a cross-sectional size of the vasculature, and determines therefrom a location of the distal tip.
An ultrasound system can simultaneously disinfect skin of a patient while ultrasound imaging thereunder. The ultrasound system can include a console, an ultrasound probe operably connected to the console, and a stimuloresponsive antimicrobial ultrasound gel selected from at least a sonoresponsive antimicrobial ultrasound gel and a photoresponsive antimicrobial ultrasound gel. The ultrasound probe can include an ultrasound sensor array for both the ultrasound imaging and the disinfecting of the skin with the sonoresponsive antimicrobial ultrasound gel via one or more sonosensitizers thereof. The ultrasound probe can also include one or more light emitters configured to emit light toward the skin for the disinfecting of the skin with the photoresponsive antimicrobial ultrasound gel via one or more photosensitizers thereof.
A connection system including a device connector coupled with an equipment connector through a sterile barrier to define an electrical and optical connection. The sterile barrier includes a tubular portion and when connected, a portion of the device connector is disposed in the tubular portion and the tubular portion is disposed within a cavity of the equipment connector. The optical connection and electrical connection are established with the cavity of the equipment connector, the tubular portion, and a cavity of the equipment connector. A detent mechanism secures the device connector to the equipment and provides haptic feedback upon connection. The connection system can be employed by a medical system configured to track the location of a distal tip of a medical device within a patent body.
A needle guidance system includes a patient imaging system, such as an ultrasound guidance system (UGS) combined with a needle tip location system (TLS). The UGS defines a needle pathway to access an epidural/ spinal space and overlays the pathway onto a live or frozen ultrasound image. The TLS magnetically determines a magnetic distal tip location of the needle including a depth with respect to a magnetic field sensor placed on the patient. A distal tip image overlayed atop the ultrasound image at a determined distal tip location. The UGS identifies the epidural/ spinal space including a depth thereof within the ultrasound image. The UGS determines that the distal tip is located within the epidural/ spinal space when the depth of the distal tip equals the depth of the epidural/ spinal space. A probe securing apparatus secures an ultrasound probe of the UGS to the patient.
An accessory device (100) for an ultrasound system (10) includes an inverted U-shaped clamp portion (210) configured to attach to an ultrasound probe connector (50) and a hook portion (250) configured to receive therein a portion of an ultrasound cable (30). The hook extends laterally beyond a right side of the system module. The hook portion is rotated and laterally positioned offset with respect to clamp portion. Left and right legs (224, 226) of the clamp portion include at least one of a longitudinal curve, a lateral curve, or one or more inward protrusions (334, 336). An ultrasound probe assembly may include the cable management device. The accessory device may be formed integrally with the ultrasound probe connector. Additional accessory devices include a probe holder (520) and cable spool (600). Combination accessory devices may include any combination of the hook, the probe holder or the cable spool coupled with the clamp. Ultrasound probe assemblies may include any of the accessory devices.
B65H 75/12 - Kinds or types of circular or polygonal cross-section with a single end flangeKinds or types of circular or polygonal cross-section formed with one end of greater diameter than the barrel
A61B 8/00 - Diagnosis using ultrasonic, sonic or infrasonic waves
B65H 75/14 - Kinds or types of circular or polygonal cross-section with two end flanges
B65H 75/28 - Arrangements for securing ends of material
An access needle system includes a body defining a bottom surface configured to engage a skin surface of a patient, a needle hub releasably coupled to the body, the needle hub supporting a transversely extending needle, and a left and right wing hingedly coupled to the needle hub. The left wing can include a left main hinge configured to pivot the left wing between a vertical position and a horizontal position, and a left sub-hinge configured to pivot a left outer leaf relative to a left inner leaf from an aligned position to a folded position. The right wing can include a right main hinge configured to pivot the right wing between a vertical position and a horizontal position, and a right sub-hinge configured to pivot a right outer leaf relative to a right inner leaf from an aligned position to a folded position.
Therapeutic systems and methods for medical treatment use magnetoresponsive materials and structures. For example, a therapeutic system can include an elongate medical device and a magnetic-field generator. The elongate medical device can include a luminal coating, an abluminal coating, or both over at least a distal portion of the elongate medical device. Such a coating can include one or more magnetoresponsive submicron materials responsive to a magnetic field generated by the magnetic-field generator. When the magnetic field is directed toward the coating, the medical treatment can be administered. The medical treatment can be selected from local hypothermia, targeted delivery of one or more therapeutic agents, and combinations thereof for disrupting any thrombotic or non-thrombotic occlusions on the elongate medical device or another elongate medical device. Alternatives to the coating can include formation of the distal portion of the elongate medical device with a magnetoelastic material or magnetoresponsive structure thereon.
An access assembly for use with an intraosseous access device includes a safety mechanism to prevent needle stick injuries. In an example, the access assembly includes a needle supported by a needle hub, and a stylet supported by a stylet hub, wherein the stylet engages the needle lumen and includes a recess disposed a longitudinal length from a distal tip of the stylet. The access assembly further includes a plate shield comprising a housing slidably engaged with the needle hub, and a plate with an aperture and a plurality of fingers angled towards the distal end of the housing. The plate shield provides protection and stability during insertion and removal of the intraosseous access device, thereby ensuring safe and efficient access to the bone marrow without any needle stick injuries.
Ultrasound probes that include vibration transducers configured to vibrate skin or other tissue during a vascular access procedure. A first subset of the vibration transducers can cause ultrasonic vibrations of a first patient interface surface of the probe to obtain an ultrasound image. A second subset of the vibration transducers can cause vibrations of a second patient interface surface of the probe at a frequency different from the ultrasonic frequency to reduce a pain associated with the vascular access procedure. The second patient interface surface may extend laterally away from the ultrasound probe toward an insertion site. The second patient interface surface may include a vascular access device.
Sanitary articles of manufacture can include a portion up to an entirety of each sanitary article formed of polyurethane, incorporating the polyurethane, or covered with one or more layers of the polyurethane. The polyurethane can include a hard segment including hard-segment residues of a diisocyanate and a chain extender; a soft segment including soft-segment residues of a polyglycol; a cationic modifier incorporated into main chains of the polyurethane, side chains of the polyurethane, or both; and an anionic active agent ionically bonded to the cationic modifier, which anionic active agent provides antimicrobial or antifouling properties to the sanitary article. Optionally, the sanitary article can include an odorant dispersed in the polyurethane. The sanitary article can be configured for fixing to a physical location or remaining removable from the physical location. Such a physical location can include a bathroom or kitchen.
C08G 18/12 - Prepolymer processes involving reaction of isocyanates or isothiocyanates with compounds having active hydrogen in a first reaction step using two or more compounds having active hydrogen in the first polymerisation step
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 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.
An infection-sensing medical system can include an indwelling medical device and a dedicated computing device. The indwelling medical device can include an intracorporeal conduit configured to be percutaneously inserted into a blood vessel of a patient and a microcontroller integrated into a portion of the indwelling medical device. The microcontroller can include a chemical-sensor module and one or more chemical sensors configured to generate electrical signals in response to interactions with one or more volatile organic chemicals ("VOCs") associated with the patient. The microcontroller can also include a microcontroller processor configured to generate chemical-sensor data from the electrical signals. The dedicated computing device can include a computing-device processor configured to generate one or more observed chemical signatures from the chemical-sensor data as well as determine whether the patient has a microbial infection by comparison of the one-or-more observed chemical signatures to known chemical signatures for microbial infections.
A61B 5/08 - Measuring devices for evaluating the respiratory organs
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
40.
SYSTEM AND METHOD FOR SUGGESTING CATHETER PARAMETERS
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 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
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.
A61M 5/42 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
42.
SYSTEM AND METHOD FOR EARLY IDENTIFICATION OF DIFFICULT VENOUS ACCESS OF A PATIENT
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 set 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.
G16H 20/40 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
An antimicrobial catheter (100) can include one or more polymeric inserts (110) of a filled polymer in a catheter tube (102), a catheter hub (104), one or more extension legs (106), one or more extension- leg fittings (108) or a combination thereof. Each polymeric insert of the one-or-more polymeric inserts can provide a portion of a luminal surface (112) 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 (116) 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 catheter assembly can include a catheter (100), a controller (104), and an internal power source (106). The catheter can include a catheter tube (108) and a catheter hub (102), 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 (112) 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 (54) in which at least a portion of the catheter (42) is initially disposed, a hollow needle (16) distally extending from the housing with at least a portion of the catheter pre-disposed over the needle, and a guidewire (22) pre-disposed within the needle. A guidewire advancement assembly (20) 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 (140) is also included for selectively advancing the catheter into the patient. The catheter advancement assembly includes a mechanical advantage mechanism (1200) coupled between the slide of the insertion tool and the catheter.
Catheter placement assemblies 100 having automatic guidewire disengagement can include a handle 170 and seal housing 180 assembly defining a needle lumen 172 and guidewire lumen 174. Once the vasculature is accessed, the guidewire 130 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 178 and/or timing lock mechanism 190. 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.
A system, apparatus and method are directed to a magnetizer comprising at least one magnetizing element and an irradiation ssoouurrccee.. 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.
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.
G16H 50/30 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indicesICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for individual health risk assessment
A medical needle assembly includes a stylet having non-circular cross-sectional shape disposed within the needle lumen. The needle and the stylet each define respective electrodes that enable ascertainment of an electrical property of a body substance adjacent the distal tip of the needle. An electrically insulative coating having a uniform thickness covers the stylet. Wire leads enable connection of the electrodes to a measurement module configured to measure an electrical property of a body substance adjacent a distal end of the needle during insertion. Electrical property measurement enables identification of the location of the needle tip within the patient based on the measurement value. A major diameter of the non-circular cross- sectional shape extends across the needle lumen to create first and second flow paths extending along the lumen on opposite sides of non-circular cross-sectional shape. The first and second flow paths enable blood to flow along the lumen during use.
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
50.
SYSTEM AND METHOD FOR PLACEMENT OF A CENTRAL CATHETER TIP
A medical system includes a vascular device operatively coupled with a system module. The vascular device includes a pressure measurement capability as the distal end thereof. Logic of the system module acquires and pressure measurements during downstream advancement of the vascular device along a venous vasculature. The logic determines that the distal end of the vascular device is advanced to a defined location, such as the cavoatrial junction, for example, based on a minimum average pressure and/or maximum pressure variation. The vascular device may include a pressure sensor located at the distal end. The pressure sensor may include fiber optic Bragg grating of an optical fiber extending along the vascular device. The vascular device may be central catheter.
Ultrasound gel-treating stations, systems, and methods enable at least germicidal ultraviolet ("UV")-light treatment of ultrasound gel. For example, an ultrasound gel-treating station can include a housing, a cavity within the housing, and one or more UV-light sources disposed in the cavity or the housing about the cavity. The cavity within the housing can be configured to hold one or more bottles of ultrasound gel. The one-or-more UV-light sources can be configured for irradiating the one-or-more bottles of ultrasound gel with germicidal radiation when the one-or-more bottles of ultrasound gel are disposed in the cavity. Heat dissipated by the one-or-more UV-light sources can warm the one-or-more bottles of ultrasound gel. Additionally or alternatively, the ultrasound gel -treating station can further include one or more heating elements disposed in the cavity or the housing about the cavity for warming the one-or-more bottles of ultrasound gel.
A medical network system is communicatively coupled with a number medical device tracking systems that utilize magnetic systems to track elongate medical devices along anatomical pathways within patients having differing physical attributes, such as height and weight. The medical network system collects tracking records from the medical device tracking systems and applies machine learning and/or artificial intelligence technics to the tracking record data to correlate recorded anatomical pathways with the differing physical attributes. The medical network system receives a patient value set of physical attributes for a specific patient from a medical device tracking system and provides a predicted anatomical pathway based on the correlation and the patient value set. The medical device tracking systems tracts the elongate medical device with respect to the predicted anatomical pathway during placement. The medical device tracking systems may also utilize fiber optic shape sensing systems to track the placement of elongate medical.
Ultraviolet light disinfection systems expose medical devices, surfaces, patients and healthcare clinicians to UV light having wavelengths consist with killing microorganisms. UV light systems may use logic to govern the operation of UV light sources so as to apply a disinfecting dose of the UV light. UV detectors measure UV light exposure. Enclosures contain medical devices and flood the medical devices with the UV light. Some enclosures accommodate a person. Some UV systems project UV light onto high-touch surfaces of a healthcare environment. Some systems may be deployed within a patient transport vehicle. Some UV systems may be incorporated into medical devices.
A catheter-disinfecting system can include, in some embodiments, an introducer sheath and a germicidal irradiation means for irradiating a catheter tube of a catheter with germicidal radiation. The introducer sheath can include a sheath body configured to be percutaneously inserted into an insertion site of a patient. The germicidal irradiation means can be configured for irradiating the catheter tube as the catheter tube is inserted into a lumen of the introducer sheath, thereby disinfecting the catheter tube immediately before insertion into the insertion site. A method of disinfecting a catheter such as the foregoing catheter can include inserting the catheter tube into the introducer sheath while the introducer sheath, itself, is percutaneously inserted into the insertion site of the patient; and irradiating the catheter tube with the germicidal radiation while inserting the catheter tube into the introducer sheath.
Coated medical devices include coated catheters. For example, a coated catheter can include a catheter tube of a tubular substrate and a coating thereover. The tubular substrate can be of a first polymeric material transparent to electromagnetic radiation in a range of visible light. The coating can be of a second polymeric material anchored to the tubular substrate by chain ends of the second polymeric material impregnated in the first polymeric material by way of a spent visible-light photoinitiator. Methods of coating can include methods of coating medical devices such as the coated catheter. For example, a method of coating can include irradiating a tubular substrate impregnated with a visible-light photoinitiator with the foregoing electromagnetic radiation while the tubular substrate is disposed in an aqueous solution of a monomer, thereby initiating a radical polymerization of the monomer and coating the tubular substrate with the coating of the second polymer material.
A catheter system includes a vascular catheter having a catheter tube configured for placement within a patient body. A system module incorporated into the catheter tube adjacent to the distal tip includes first and second electrodes disposed within the lumen and coupled with the luminal wall adjacent the distal tip. A console coupled with the first and second electrodes includes logic that determines an electrical impedance between the first and second electrodes, where the impedance is related to thrombus formation and/or the bacterial adhesion within the lumen. The system module provides a wireless notification when the impedance exceeds a defined limit. A secondary system includes a light activated surface coating applied to an inside luminal wall surface. Energizing a light source activates the surface coating to release an agent (e.g., an active pharmaceutical ingredient or an anti-coagulant agent) to reduce effects of the thrombus formation and/or the bacterial adhesion.
A61B 5/0538 - Measuring electrical impedance or conductance of a portion of the body invasively, e.g. using a catheter
A61B 18/00 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
A61B 18/12 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
An infusion system for in-line disinfection of a prepared infusate with UV light can include a vascular access device ("VAD") and a UV light ring. The VAD can include an intracorporeal conduit, one or more extracorporeal conduits fluidly connected to the intracorporeal conduit, a hub between a proximal portion of the intracorporeal conduit and one or more respective distal portions of the one-or-more extracorporeal conduits, and one or more respective connectors of the one-or-more extracorporeal conduits. The intracorporeal conduit is configured to be percutaneously inserted into a patient, and the extracorporeal conduit is configured to remain outside a body of the patient. The UV light ring can be configured to encircle a portion of an infusion lumen of the VAD and irradiate the prepared infusate within the infusion lumen with the UV light for infusing a disinfected infusate into the patient during an infusion of the patient.
A61M 5/00 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests
Various embodiments of an intraosseous port configured for subcutaneous placement within a patient. Some embodiments include a pair of cavities, each cavity including a septum for receiving a needle. Other embodiments include a graft extending between the cavities. Each cavity is coupled with a lumen extending into a cavity of a bone during use, e.g., a medullary cavity. A method includes extracting a bodily liquid from the bone cavity and returning the bodily liquid back to the bone cavity. Some methods include performing hemodialysis via the intraosseous port.
A disinfection system can include a console and an operably connected disinfection unit. The console can have electronic circuitry including memory with executable instructions configured to cause the console to perform various processes when executed by one or more processors of the console. The various processes can include characterizing with medical¬ device characterization logic characteristics of at least an elongate portion of a medical device for establishing or maintaining vascular access in a patient. The various processes can also include determining with disinfection logic a disinfection profile for disinfecting at least the elongate portion of the medical device with ultraviolet ("UV") light. The disinfection unit can include a disinfection compartment suitably sized to enclose the medical device therein. A UV- light source disposed in the disinfection compartment can be for disinfecting at least the elongate portion of the medical device with the UV light in accordance with the disinfection profile.
A rapidly insertable central catheter (RICC) insertion assembly (100) includes a RICC, an introducer needle (106) and a coupler (108) for coupling them together. The needle (1069 includes a needle hub and a composite shaft including a sheath over a needle shaft sealing a needle slot of the needle shaft thereunder. The coupler (108) includes a housing and a valve module disposed within. The composite shaft passes through an introducer-needle passageway defined by a valve¬ module housing such that the valve module forms a seal over a sheath opening of the sheath in a ready-to-deploy state of the RICC insertion assembly. The valve module includes a needle-stick-injury protection mechanism configured to capture a distal needle tip of the needle shaft within the valve module when the introducer needle is withdrawn from the coupler in a proximal direction.
A disinfection device for disinfecting a hub of a medical device includes a housing having a first end and a second end, a power source, an ultraviolet light source, and a connection mechanism located at the first end of the housing, wherein connection of the hub of the medical device to the disinfection device initiates a disinfection process configured to disinfect the hub. the ultraviolet source may be a light emitting diode with a peak of wavelength within the range of 100-400nm (specific implementations being 225-264 nm) and the connection mechanism includes one or more of a screw thread, a channel, ridge, a friction fit connector, a magnet, or a ferromagnetic material. The disinfection device may include a port located on the second end, wherein the one or more port is configured for coupling to an external device and receiving a charge or power supply from the external device.
A disinfecting device having a housing and an ultraviolet source located in the housing. The disinfecting device may include a tube that includes a first end connected to the housing and a second end free of the housing. An end cap may be located at the second end of the tube. In use, ultraviolet light may be emitted from the ultraviolet source and propagated to the end cap in order to disinfect a portion of a medical device.
A catheter placement system includes a stylet disposed within a lumen of a catheter. The stylet includes an optical fiber configured for shape sensing. A device handle is selectively coupled with the stylet and selectively locked to the stylet to fix the position of the device handle along the stylet. A system module is operatively coupled with the stylet and logic of the system determines a shape of the stylet and depicts the shape on a display. The device handle is coupled with the stylet such that the optical fiber detects the position of the device handle along the stylet and the logic depicts a device handle icon together with the stylet shape. In accordance with temperature differences detected by the optical fiber, the logic determines the position of the insertion site along the stylet. The logic further depicts an insertion site icon together with the stylet shape.
A system includes a catheter (10) and one or more fillers, or plugs (400, 500, 600, 702, 704), configured to block a lumen (14) of the catheter. The catheter may include an elongate tube (12) having a distal end (12B) and defining a plurality of lumens (14). A distal tip structure (170) may be located adjacent to the distal end. A plug may be configured to be positioned within a first portion of a first lumen of the plurality of lumens proximal the distal tip. The plug includes an oval cross-sectional shape and may be formed of a biocompatible polymeric material such as silicone, nylon, polyurethane, polyethylene terephthalate, latex, a plastic, a thermoset, or a thermoplastic elastomer. The oval cross-sectional shape has a first and a second vertices, where the first plug is configured such that either of the vertices may be positioned near an upper side of the first lumen without causing bulging of a wall of the lumen.
A system for treating infections in patients that includes an elongate probe configured for insertion into the patient body and a system module coupled with the probe. Sensors are disposed along the probe that detect infectious substances or physiological symptoms of the patient. The probe also includes light disseminating devices configured to expose the infectious substances to a light capable of disrupting the infectious substances, such as light within the ultraviolet spectrum. System logic may activate the light disseminating devices in response to sensor signals. A wireless connection enables clinician interaction with the system via external computing devices. The sensors may be disposed on external surfaces or internal luminal surfaces of the probe. The light disseminating devices may project the light away from the external surfaces or within a lumen of the probe. The light disseminating devices may include optical fibers.
A catheter placement system that includes a catheter placement device having elongate body configured for insertion into a catheter lumen, where the elongate body includes a body lumen. A compartment at a proximal end of the body is in fluid communication with the body lumen. A saline solution disposed within the compartment and the body lumen defines an electrical path along the elongate body and an electrode at a distal end of the elongate body. A stylet extends along the elongate body, where the stylet includes a multi-core optical fiber extending along the stylet, and where the multi-core optical fiber includes a number of fiber Bragg gratings disposed along the optical fiber to enable shape sensing of the optical fiber. A system module optically and electrically coupled with the catheter placement device displays a shape of the elongate body and ECG waveform.
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 5/06 - Devices, other than using radiation, for detecting or locating foreign bodies
A61B 5/287 - Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
67.
CATHETER TIPS FOR RAPIDLY INSERTABLE CENTRAL CATHETERS AND METHODS THEREOF
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 system and method for disinfecting medical devices includes a covering for a medical cart that exposes medical devices disposed on the cart to a disinfecting ultraviolet light. The covering includes a light emitting system that includes a number of UV light sources, such as LEDs, configured to define an ultraviolet light environment beneath the covering. The light emitting system may include one or more light pipes and/or optical fibers, systems and methods. An opaque layer of the covering contains the ultraviolet light environment beneath the covering. Portions of the light emitting system suspend from the covering so as to emit UV light between adjacent medical devices on the cart.
A61G 12/00 - Accommodation for nursing, e.g. in hospitals, not covered by groups , e.g. trolleys for transport of medicaments or foodPrescription lists
Cut-to-length sensing catheters retain their sensing capabilities and methods thereof. For example, a sensing catheter can include a catheter tube having temperature sensors along an initial length thereof. Each temperature sensor is independently electronically addressed, thereby enabling a temperature-sensing capability of the sensing catheter to be maintained despite excising any one or more temperature sensors with a distal length of the catheter tube upon cutting the catheter tube to a working length. Such a sensing catheter can further include strain sensors respectively paired with the temperature sensors along the initial length of the catheter tube, thereby enabling correction of temperature-measurement uncertainty in any temperature sensor by way of a local strain measurement. Such a sensing catheter can further include lactate sensors respectively paired with the temperature sensors, thereby enabling enzyme activity and, thus, lactate concentration, associated with any lactate sensor to be normalized by way of at least local-temperature compensation.
A system for preventing or treating vascular access device (" VAD")-related thrombosis can include an ultrasound transducer configured to emit thrombus-fragmenting ultrasound into a patient about a VAD. The ultrasound transducer can include a securing means for securing the ultrasound transducer to the patient over the VAD. A method of such a system can include an ultrasound-emitting step. The ultrasound-emitting step can include emitting thrombus- fragmenting ultrasound from the ultrasound transducer into the patient about the VAD.
Systems and methods for disinfecting ultrasound probes including a disinfection module operably and physically coupled with an ultrasound-imaging system including an ultrasound probe. The disinfection module is configured to expose the external surface of the ultrasound probe to UV light to define a high-level disinfection process. Sensors determine when the ultrasound probe is disposed within a disinfecting cavity of the disinfection module and logic governs the operation of UV light sources. Logic determines a contamination level of the probe and defines an appropriate disinfection level. Exposing the probe to hydrogen peroxide is an alternative to the UV light. Logic may activate the high-level disinfection process upon placement of the probe within the cavity.
A sterile sheath configured to enshroud a non-sterile medical device. Certain non- sterile medical equipment, e.g., consoles, computing devices, etc. are not easily sterilizable without damaging the device itself. As such, these non-sterile medical devices remain outside of the sterile field. Engaging sterile medical devices that are within the sterile field with these non-sterile medical devices can compromise the sterility of the sterile field. Disclosed herein is a sheath configured to enshroud a portion of the non-sterile medical device. Further the sheath can include an access port to allow one or more sterile medical devices to engage the non-sterile medical device disposed within the sheath.
Connection systems and methods establish safe, routine, functional connections between sterile single patient-use ("SPU") medical devices and multiple patient-use ("MPU") medical devices. For example, a connection system can include a male connector associated with an SPU medical device and a female connector associated with an MPU medical device. The male connector can include a flexible member therearound but proximal of a plug of the male connector. The female connector can include a rigid member around an opening of a receptacle of the female connector. The flexible member can conform to the rigid member with a procedural barrier therebetween when the plug of the male connector is inserted into the receptacle of the female connector. Upon insertion of the plug of the male connector into the receptacle of the female connector, one or more functional connections can be established across the procedural barrier between the SPU and MPU medical devices.
Embodiments described herein are directed to an automatic catheter measurement system for determining a length of a catheter required to extend between an insertion site and a target location, prior to placement of the catheter. The system can include a measurement device that can be aligned with, and map, a three-dimensional arrangement of one or more external landmarks. The measurement device can include magnetic and/or fiber optic systems to map the external landmarks. The system then determines a framework to provide a predicted catheter length required to extend between the insertion site and target location. The measurement device can also be included with the catheter during placement to confirm the actual catheter length and improve the accuracy of future predicted frameworks.
An intravascular medical device (100) assembly, including a tubular member (101) or catheter defining a lumen (102), an elongate medical device (105) disposed within the lumen, and a cap (110) attached to and covering the distal end of the tubular member, where the cap is configured to prevent contamination and damage of the elongate medical device. The elongate medical device includes an optical fiber (106) for shape sensing and magnetic elements (131) for magnetic tracking of the device assembly during advancement along a patient vasculature. The cap is configured to form a fluid tight seal with the tubular member.
Disclosed are medical systems, devices, and methods that support landmarking of a medical device pathway within a patient. A landmarking device that is placed on the patient and coupled with a system module, includes magnetic elements and/or a shape sensing optical fiber to enable determining a position and shape of a landmarking pathway by logic of the system module. A medical device correspondingly includes magnetic elements and/or a shape sensing optical fiber that enable determining an actual pathway of the medical device by logic of the system module during insertion of the medical device. An image of the landmarking pathway combined with an image of the actual pathway are depicted on a display. The logic compares the actual pathway with the landmarking pathway and provides an alert accordingly.
Rapidly insertable central-catheter ("RICC") insertion assemblies and associated methods include valve modules. For example, a RICC insertion assembly can include a RICC, an introducer needle, and an access guidewire coupled together by a coupler in which a valve module is disposed. The introducer needle includes a needle shaft having a longitudinal needle slot and a sheath over the needle shaft sealing the needle slot thereunder except for that under a sheath opening of the sheath. The valve module includes an elastomeric gasket encircling at least a portion of a valve-module compartment of the coupler housing. In a ready-to-deploy state of the RICC insertion assembly, the gasket is compressed in the valve-module compartment around both the introducer needle and the access guidewire where the access guidewire extends from the sheath opening, thereby creating a substantially air-tight space within the gasket around the introducer needle and the access guidewire.
Ultrasound probe assemblies include a probe, a sheath, and an accessory implement that may be selectively attached to and detached form the probe. The implement includes an attachment surface for attaching accessories thereto. The attachment surface can include a defined angle with respect to the head of the probe so that accessories attached thereto are disposed in a defined alignment with the probe. The implement can include a circumferential wall defining a cavity configure to receive the probe head therein. The cavity can include a bottom opening to expose a patient coupling surface of the probe. The assembly can include an ultrasound gel disposed within the opening. The sheath can include a stretchable band to secure the sheath to the probe. The sheath defines a sterile barrier and may be attached to the implement.
A medical ultrasound system that includes an ultrasound probe and an accessory interface apparatus configured to optionally couple with any medical device or system to enhance the functionality of the ultrasound system. The accessory apparatus exchanges data with the probe and receives power from the probe. The accessory apparatus includes processors and logic that governs its operation thereby adding functionality to the probe. The accessory apparatus receives input and provides output via any of a number of communication mechanisms, i.e., wireless, electrical, optical, inductive, RFID, IR, and the like. The optional accessories may 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. Additional accessories may include a needle guide, a triphalangeal support structure, or an acoustically transparent cap.
An ultrasound-imaging system is disclosed that includes an ultrasound probe and a console. The ultrasound probe includes an array of ultrasonic transducers configured to emit generated ultrasound signals into a patient, receive reflected ultrasound signals, and convert the reflected ultrasound signals into corresponding electrical signals of the ultrasound signals for processing into an ultrasound image, and a component configured to obtain positional- tracking data as the ultrasound probe moves along the patient from a starting position to an end position. The console includes one or more processors and a computer-readable medium storing logic that, when executed, causes operations including: receiving and processing the electrical signals to generate the ultrasound image, receiving the positional-tracking data, determining metrics of a path traveled by the ultrasound probe, and providing insertion recommendations corresponding to a medical device to be inserted into the patient based on the metrics of the path traveled by the ultrasound probe.
Disclosed herein is an ultrasound training system that according to various embodiments includes an ultrasound probe, a vascular access device, and a patient simulation block. Logic of the system tracks the location and orientation of the probe and the vascular access device via magnetic tracking, fiber optic shape sensing, inertia measurement or any combination thereof. The logic depicts the vascular access device in relation to the patient simulation block on a display along with a simulated ultrasound image. The patient simulation block may include artificial anatomical elements and the logic may depict simulated anatomic elements aligned with the artificial anatomical elements. The probe includes a load sensor and the logic depicts an anatomic element having a shape affected by the load. The vascular access device includes magnetic elements defining a magnetic signature and the logic depicts the type and/or size of the vascular access device based on the magnetic signature.
A shape-sensing system can include an optical-fiber probe and a vibration-assisted torsion-management means for managing torsion in the optical-fiber probe. The optical-fiber probe can be configured to be removably disposed in an elongate medical device. The optical- fiber probe can include an inner construction and an outer construction over the inner construction but detached therefrom over a majority of the optical-fiber probe. The inner construction can include one or more optical-fiber cores disposed in a cladding. The outer construction can include a mechanical layer. The vibration-assisted torsion-management means can be operably coupled to the optical-fiber probe for vibrating either the inner construction or the outer construction of the optical-fiber probe relative to the other, which mitigates or eliminates any optical signal-distorting torsion in the inner construction of the optical-fiber probe. A method of the shape-sensing system can include managing torsion of the optical-fiber probe with the vibration-assisted torsion-management means.
Disclosed herein are medical systems, devices, and methods for performing vascular treatments and diagnoses. A vascular device include 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 perform 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.
An ultrasound probe including an array of ultrasonic transducers and an orientation system, wherein the orientation system obtains orientation information of the ultrasound probe. In addition, a console for communicating with the ultrasound probe, the console including one or more processors and non-transitory computer-readable medium having stored thereon logic, when executed by the one or more processors, causes operations including: obtaining the orientation information, performing an identification process on the ultrasound signals to identify an anatomical target (target vessel), determining, based on the orientation information, a direction of movement required by the ultrasound probe to place the ultrasound probe at a position relative to the ultrasound probe over the anatomical target, and initiating provision of feedback of the ultrasound probe indicating the direction of movement required by the ultrasound probe to place the ultrasound probe at a position relative to the ultrasound probe over the anatomical target.
Systems and methods include those for automatically determining needle guides for establishing vascular access. For example, a system can include an ultrasound probe, a console operably coupled to the ultrasound probe, and a display screen integrated into the console. The console can include one or more processors and memory including instructions configured to instantiate one or more processes when executed by the one-or-more processors for automatic determination of a needle guide in accordance with ultrasound-imaging data, historical data, or a combination thereof. The automatic determination of such a needle guide can use logic, algorithms, machine learning, artificial intelligence, or a combination thereof. The display screen can be configured to display an ultrasound image including one or more blood vessels below a skin surface of a patient as well as the needle guide resulting from the automatic determination for establishing vascular access to the one-or-more blood vessels in the ultrasound image.
Disclosed herein are medical systems, devices, and methods for identifying a blood vessel as a vein or as an artery. The system includes an optical fiber configured for insertion into a blood vessel coupled with a console having a light source, an optical receiver, processors, and logic stored in memory. The optical fiber includes sensors disposed along its length configured to determine a state or condition of the optical fiber, where the state or condition includes a strain, movement, pressure, or temperature. The logic analyzes reflected optical signals emanating from the sensors to determine that the optical fiber is inserted within an artery or within a vein. Logic may also determine a red-blue shift of a projected light to determine a blood flow direction with respect to the optical fiber.
Disclosed herein is a system, apparatus and method directed to obtaining first data indicative of a first location within the patient vasculature, obtaining second data that is indicative of a second location within the patient vasculature, performing a confirmation process that includes determining whether the second location corresponds to the first location within a predetermined threshold, and when the second location is determined to correspond to the first location within the predetermined threshold, determining the first location accurately indicates the current location of the distal tip of the medical device. The first modality may be any of a fiber optic modality, a magnetically-based tip location system modality, or an electrocardiogram monitoring system modality and the second data may represent fluctuations of the distal tip of the medical device. The medical device may be an introducer wire, a guidewire, a stylet, a stylet within a needle, a needle, or a catheter.
Disclosed are systems and methods for automatic determination of one or more medical devices for vascular access prior to direct patient assessment. For example, a system can include a console and a display screen optionally integrated into the console. The console can include one or more processors and memory. The memory can include instructions configured to instantiate one or more processes when executed by the one-or-more processors for the automatic determination of the one-or-more medical devices for vascular access in accordance with a plurality of data inputs, various operating parameters, historical data, or a combination thereof. The automatic determination of the one-or-more medical devices can use at least logic, algorithms, machine learning including a machine-learning model trained with the historical data, artificial intelligence, or a combination thereof. The display screen can be configured to display the one-or-more medical devices recommended for vascular access.
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
G16H 20/40 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
G16H 40/40 - 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 management of medical equipment or devices, e.g. scheduling maintenance or upgrades
G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
89.
SHAPE SENSING FIBER OPTIC TIP PROTECTION SYSTEMS AND DEVICES
Fiber-optic assemblies for insertion within a patient body include an optical fiber and a secondary mechanical layer extending around a circumference of the optical fiber along at least the distal portion of the optical fiber. A distal tip section of the optical fiber includes a portion of the optical fiber disposed within a circuitous path, or an expansion of the optical fiber. The optical fiber may be a shape sensing optical fiber. A medical device assembly includes the fiber-optic assembly coupled with a catheter, a stylet, a probe, or a guidewire. The secondary mechanical layer and/or the expansion may be formed of an electrically conductive material.
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/103 - Measuring devices for testing the shape, pattern, size or movement of the body or parts thereof, for diagnostic purposes
A61B 5/107 - Measuring physical dimensions, e.g. size of the entire body or parts thereof
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
90.
SYSTEMS AND METHODS FOR AUTOMATICALLY RECOMMENDING A MEDICAL DEVICE FOR VASCULAR ACCESS
Disclosed are systems and methods for automatically recommending medical devices for vascular access. For example, a system can include an ultrasound probe, a console operably coupled to the ultrasound probe, and a display screen integrated into the console. The console can include one or more processors and memory including instructions configured to instantiate one or more processes when executed by the one-or-more processors for the automatic recommending of the medical device for vascular access. The automatic recommending of the medical device for vascular access can be in accordance with a plurality of data inputs, various operating parameters, or a combination thereof. The display screen can be configured to display an ultrasound image including one or more blood vessels below a skin surface of a patient. The display screen can also be configured to display the medical device recommended for vascular access of the one-or-more blood vessels in the ultrasound image.
A medical ultrasound system can include an ultrasound probe and one of a number of optional accessories attached to the ultrasound probe. An accessory can exchange data with the probe and receive power from the probe. The accessory can include processors and logic that govern its operation, thereby adding functionality to the probe. The accessory can receive input and provide output via any of a number of communication mechanisms, e.g., wireless, electrical, optical, RFID, IR, or the like. The accessory can add functionality to the probe, such as shape sensing via fiber optic shape sensing, obtaining electrical signals, obtaining bio-impedance measurements, tracking a needle, or determining an orientation of the probe. The accessory can include a needle guide, a triphalangeal support structure, or an acoustically transparent cap.
A medical device guide system that includes an ultrasound probe is configured for imaging portions of a patient's body. The system is configured to automatically position and/or orient a needle guide with respect to the probe in accordance with a desired needle trajectory with respect to the target blood vessel. The system includes one or more of a blood vessel detection system, a probe orientation system and/or a needle tracking system to facilitate automatically positioning of the needle guide. Some needle guides include multiple channels that define different angles of needle insertion. The needle guide is selectively coupled with a needle guide connector that is operatively coupled with the probe via an electro-mechanical mechanism.
Controlling stiffness of medical devices is enabled through systems (100), same or different medical devices (104), and methods. For example, a system (100) can include an elongate medical device (102, 104) such as a stylet and a pneumatic or hydraulic pump station (110). The medical device can include a tubular body (116) with a lumen (118). The lumen, which terminates proximal of a distal end of the medical device, can be configured to contain a fluid. The pump station can be configured to pressurize the fluid and, thereby, stiffen at least a distal portion of the medical device. Being as the tubular body of the medical device is configured to be disposed in another lumen (120, 122, 124) of another elongate medical device (106, 108) such as an intravenous catheter, any stiffness in the medical device (e.g., the stylet) can be imparted to the other medical device (e.g., the catheter) when disposed therein.
Steering medical devices is enabled through systems, same or different medical devices, and methods. For example, a system can include an elongate medical device (102) and a pump station (110). The medical device can include a tubular body (116) with a lumen (118). The lumen, which terminates proximal of a distal end of the medical device, can be configured to contain a fluid. The pump station can be configured to pressurize the fluid and, thereby, induce a curve in at least a distal portion of the medical device for steering the medical device through one or more anatomical lumens. Being as the tubular body of the medical device (e.g., a stylet) can be disposed in another lumen of another elongate medical device (e.g., a catheter), any curvature in the medical device can be imparted to the other medical device when disposed therein for steering the other medical device through the one-or-more anatomical lumens.
Placing elongate medical devices (195) with tortuous vascular pathways can be challenging. The system (100) and methods disclosed include a stylet (130) having a shapeable portion (630) formed of a shape-memory, super-elastic material such as Nitinol. The stylet (130) can be placed within a catheter (195) and includes a fiber-optic strain sensor (FOSS) system configured to determine a shape of the stylet (130). Passing a fluid of a predetermined temperature through a lumen (310) of the catheter (195) modifies the temperature of the shapeable portion (630) which in turn modifies a shape and/or flexibility state of the shapeable portion (630). Modifying the shape of the shapeable portion (630) can modify an angle at which a distal tip of the stylet extends relative to the central longitudinal axis. A user can then rotate and advance the distal tip to negotiate tortuous vascular pathways. Similarly, modifying a flexibility of the shapeable portion (630) can facilitate negotiating tortuous vascular pathways.
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
Fiber-optically enabled medical device systems, and associated methods, include an elongate medical device having an optical fiber and one or more conductive elements. The optical fiber is configured to determine a shape of the medical device as the device negotiates tortuous vascular pathways. The one or more conductive elements can be configured to transmit electrical signals there along between the distal tip and a console coupled to a proximal end of the medical device. The electrical signals can determine a location of a tip of the medical device, detect an electrophysiological signal at a distal tip, and/or provide electro-stimulation or ablation energy to the distal tip of the medical device. The one or more conductive elements can be a wire extending linearly or helically about the optical fiber, or can be a tube, or tube section, extending annularly about the optical fiber, or combinations thereof.
Strain-sensing systems, indwelling medical devices, and methods for determining one or more physical attributes are disclosed. A strain-sensing system can include, for example, an indwelling medical device, an optical interrogator, and a console. The medical device can include an optical-fiber probe having fiber Bragg grating ("FBG") sensors. The optical interrogator can be configured to send input optical signals into the optical-fiber probe and receive FBG sensor-reflected optical signals therefrom. The console can include one or more processors, memory, and executable instructions that cause the console to perform a set of operations including: receiving the FBG sensor-reflected optical signals from the optical interrogator; converting the FBG sensor-reflected optical signals into converted electrical signals with optical signal-converter logic; and determining in a real-time determination the one-or-more physical attributes associated with a heart, lungs, or both the heart and lungs from at least the converted electrical signals with physical attribute-determination logic.
An ultrasound imaging system having an ultrasound probe, one or more sensors, and a feedback system are all in communication with a console. The ultrasound probe includes an ultrasound transducer array configured to capture one or more ultrasound images of a target area. The one or more sensors are coupled to the ultrasound probe and to detect and track a magnetic signature of a needle in three-dimensional space within the target area. The feedback system provides two or more types of feedback to a user, including feedback related to each of identifying and distinguishing the target vessel from the other anatomical targets, tracking the needle along a needle trajectory, or confirming the needle has accessed the target vessel. The console is configured to activate the feedback system, determine the target vessel, and determine a needle trajectory to access the target vessel.
Tracking elongate medical devices within the body of a patient can be challenging. Medical systems and devices to address the foregoing include an elongate probe configured for insertion into a patient and/or a catheter. The elongate probe includes an optical fiber and a number of electrical conductors extending along the elongate probe. The probe further includes a tip electrode and a number of band electrodes for obtaining an ECG signal and a bioimpedance, respectively. The optical fiber is configured for shape sensing and to detect strain and fluctuations of the probe. A system includes the probe, and a logic of the system is configured to determine a location of the probe along a vasculature and further determine a location of a catheter with respect to the probe via optical signals and/or electrical signals.
An ultrasound imaging system is used to place a catheter within 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 other anatomical targets within a target area. The ultrasound array is in communication with a console configured to automatically detect the target vessel within the one or more ultrasound images and determine a catheter purchase. The ultrasound imaging system further includes one or more sensors in communication with the console, the one or more sensors configured to detect and track one or more magnetic signatures of an elongate medical device within the target area.
patents
