Abstract: System 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.

Abstract: 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.

Abstract: 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.

Abstract: An intravascular medical device assembly, including a tubular member or catheter defining a lumen, an elongate medical device disposed within the lumen, and a cap 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 for shape sensing and magnetic elements 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.

Abstract: Optical-and-electrical medical systems and methods thereof are disclosed. Such a medical system can include a console, an optical shape-sensing (“OSS”) medical device including an optical-fiber stylet, one or more electrical medical devices, and a relay module for establishing one or more optical or electrical relay connections between the relay module and a remainder of the medical system including the console. The console can be configured for converting reflected optical signals from the optical-fiber stylet into shapes thereof for display. The relay module can include a primary receptacle configured to accept insertion of a medical barrier-piercing plug of the OSS medical device and establish a through-barrier optical connection therebetween. The relay module also can include one or more secondary receptacles configured to accept insertion of a corresponding number of electrical plugs of the one-or-more electrical medical devices and establish one or more under-barrier electrical connections therebetween.

Abstract: Disclosed herein are ultrasound probe assemblies that include the 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 includes 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 includes a circumferential wall defining a cavity configure to receive the probe head therein. The cavity includes a bottom opening to expose a patient coupling surface of the probe. The assembly may include an ultrasound gel disposed within the opening. The sheath may include a stretchable band to secure the sheath to the probe. The sheath defines a sterile barrier and may be attached to the implement.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: Systems and methods for navigation and positioning a central venous catheter within a patient. The system may include a first pole and a second pole designed to generate an electric field sufficient to obtain a plurality of field measurements. The system may include a stylet inserted into a medical device. The stylet may include a magnetic assembly configured to produce a magnetic field positioned along a distal portion of the stylet, and a stylet electrode positioned distal of the magnetic assembly. The stylet electrode may be designed to function as both an interior excitation electrode and an interior detection electrode. Advancement of the medical device in the patient may include using a conductance curve generated from the plurality of field measurements to identify an obstruction or malposition in the patient.

Abstract: 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.

Abstract: Disclosed is an ultrasound probe including an array of ultrasonic transducers and an orientation system, wherein the orientation system obtains orientation information of the ultrasound probe.

Abstract: Disclosed are systems and methods 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.

Abstract: 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.

Abstract: 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.

Abstract: Disclosed herein are medical systems, devices, and methods for identifying a blood vessel as a vein or as an artery. The system includes an optical fiber configured for insertion into a blood vessel coupled with a console having a light source, an optical receiver, processors, and logic stored in memory. The optical fiber includes sensors disposed along its length configured to determine a state or condition of the optical fiber, where the state or condition includes a strain, movement, pressure, or temperature. The logic analyzes reflected optical signals emanating from the sensors to determine that the optical fiber is inserted within an artery or within a vein. Logic may also determine a red-blue shift of a projected light to determine a blood flow direction with respect to the optical fiber.

Abstract: Disclosed herein are fiber-optic assemblies for insertion within a patient body, that 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.

Abstract: 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.

Abstract: Connection systems and methods for establishing optical and electrical connections through a drape are disclosed. A connection system can include a plug and a receptacle, the plug being configured to insert into the receptacle with the drape therebetween. The plug can include an optical terminal extending from a plug housing and an electrical terminal extending from the plug housing. The electrical terminal can be configured as a piercing element for piercing the drape. The receptacle can include an optical receiver within a receptacle housing and an electrical receiver within the receptacle housing. The optical receiver can be configured to form the optical connection with the optical terminal, and the electrical receiver can be configured to form the electrical connection with the electrical terminal when the plug is inserted into the receptacle with the drape therebetween.