Abstract: A catheter assembly including one or more conductive pathways to assist with placement of the catheter assembly into a patient's vasculature by enabling ECG signals emanating from the patient's heart to be detected, and a method for reconfirming an initial position of a distal end of a catheter tube of the catheter assembly. The conductive pathways can be configured to reconfirm via ECG signal detection proper placement of the catheter tube at a time subsequent to initial catheter placement into the vasculature. The catheter assembly can include an outer conductive pathway deposited on an outer surface of the catheter tube. The outer conductive pathway can have a distal end located distal to a portion of the catheter tube at a skin insertion site when the catheter tube is inserted into a patient.

Abstract: A catheter assembly including one or more conductive pathways to assist with placement of the catheter assembly into a patient's vasculature by enabling ECG signals emanating from the patient's heart to be detected. The conductive pathways can be configured to reconfirm via ECG signal detection proper placement of the catheter assembly at a time subsequent to initial catheter placement into the vasculature. The catheter assembly can include a catheter hub, a catheter tube coupled to the catheter hub, the catheter tube including at least one lumen, and an outer conductive pathway disposed on an outer surface of the catheter tube and the hub. The outer conductive pathway can have a distal end located distal to a portion of the catheter tube at a skin insertion site when the catheter tube is inserted into a patient.

Abstract: A method of positioning a catheter in a blood vessel. The method includes ultrasonically imaging the blood vessel using an ultrasound probe to generate an ultrasound image, communicating the ultrasound image to a console, and displaying the ultrasound image on the console. The method further includes coupling a stylet to the catheter, the stylet including a stylet control module including a timer circuit, and a coil assembly connected to the stylet control module. The method further includes introducing and advancing the catheter and the coil assembly in the blood vessel, sending an electric pulse signal from the timer circuit to the coil assembly at a pulse signal frequency, emitting an electromagnetic field from the coil assembly, and detecting the electromagnetic field by an external sensor. The method may further include synchronizing the pulse signal frequency, and determining a position of the coil assembly with respect to the external sensor.

Abstract: A probe cap for use with an ultrasound probe including a head portion and an acoustic surface is disclosed. In one embodiment, the probe cap includes a body that defines a cavity sized for releasably receiving the head portion of the probe therein. The probe cap body further defines a hole that is proximate the acoustic surface of the head portion. A compliant spacer component is disposed in the hole. The spacer component can include a hydrogel and provides an acoustic path between the acoustic surface and a tissue surface of a patient. The spacer component includes a skin contact surface that defines a concavity and is deformable against the tissue surface.

Abstract: A system for tracking the position of one or more medical devices for insertion into the body of a patient is disclosed. The system may also be used to locate one or medical devices at a later time after placement thereof. The present system employs multiple radiating elements that can be simultaneously detected by a sensor unit of the system, wherein at least one of the radiating elements is included with the medical device. Another of the radiating elements may be placed at a predetermined point on the skin of the patient to serve as a landmark to help determine the location of the medical device with respect to the landmark. Detection of the radiating elements by the sensor unit enables the relative positions of the radiating elements to be ascertained and depicted on a display, to assist a clinician in accurately positioning the medical device, such as a catheter.

Abstract: A system for tracking the position of one or more medical devices for insertion into the body of a patient is disclosed. The system may also be used to locate one or medical devices at a later time after placement thereof. The present system employs multiple radiating elements that can be simultaneously detected by a sensor unit of the system, wherein at least one of the radiating elements is included with the medical device. Another of the radiating elements may be placed at a predetermined point on the skin of the patient to serve as a landmark to help determine the location of the medical device with respect to the landmark. Detection of the radiating elements by the sensor unit enables the relative positions of the radiating elements to be ascertained and depicted on a display, to assist a clinician in accurately positioning the medical device, such as a catheter.

Abstract: A catheter placement system for positioning a catheter in a vasculature of a patient using at least two different modalities. The catheter placement system includes a console with a display, a stylet removably positionable within a lumen of the catheter, a tip location sensor, and an external electrode. The stylet may include an electrocardiogram (ECG) sensor assembly for detecting ECG signals of a node of a heart of the patient, and a first connector in communication with the ECG sensor assembly. The tip location sensor may be configured to detect the stylet when the catheter is disposed within the vasculature of the patient, and to communicate information of the stylet to the console. The console may be configured to receive at least one aspect of the ECG signal detected by the ECG sensor assembly indicative of proximity of the ECG sensor assembly to the node.

Abstract: A catheter placement system designed to establish a conductive pathway through a sterile barrier from a sterile field to a non-sterile field. The catheter placement system can include a stylet having a first connector including a piercing component, and a sensing component, and a data-receiving component having a second connector. The data-receiving component can be designed for positioning in the non-sterile field under the sterile barrier. The first connector can be designed to conductively connect to the second connector of the data-receiving component through the sterile barrier via the piercing component without compromising the sterile field.

Abstract: A guidance system for guiding insertion of a needle into a body of a patient utilizes ultrasound imaging or other suitable imaging technology. The guidance system can include an imaging device including a probe for producing an image of the internal body portion target, such as a blood vessel. The imaging device can be configured to provide at least one indication of status via sensory feedback based on a determined position of the needle, for example via a plurality of light-emitting diodes located on the device. One or more sensors can be included with the probe that can sense a magnetic field associated with the needle. 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 can also include a display that depicts the determined position of the needle.

Abstract: An integrated catheter placement system for accurately placing a catheter within a patient's vasculature is disclosed. In one embodiment, the integrated system comprises a system console, a tip location sensor for temporary placement on the patient's chest, and an ultrasound probe. The tip location sensor senses a magnetic field of a stylet disposed in a lumen of the catheter when the catheter is disposed in the vasculature. The ultrasound probe ultrasonically images a portion of the vasculature prior to introduction of the catheter. ECG signal-based catheter tip guidance is included in the integrated system to enable guidance of the catheter tip to a desired position with respect to a node of the patient's heart. Various methods for establishing a conductive pathway between a sterile field of the patient and a non-sterile field are also disclosed.

Abstract: An ultrasound probe assembly includes an ultrasound probe, an ultrasound cap, a solid hydrogel component, and a cover. The ultrasound probe can include a probe head and an orientation indicator. The probe head includes an acoustic surface. The ultrasound cap can include an opening defined by an opening perimeter, and a base configured to support a removable needle guide. The base can be aligned with the orientation indicator. The solid hydrogel component can include a probe-contacting side contacting the acoustic surface, a skin-contacting side extending through the opening, and an outer perimeter larger than the opening perimeter. The cover can be configured to cover the hydrogel component and at least a portion of the ultrasound cap.

Abstract: An access port for subcutaneous implantation is disclosed. Such an access port may comprise a body for capturing a septum for repeatedly inserting a needle therethrough into a cavity defined within the body. Further, the access port may include at least one feature structured and configured for identification of the access port subsequent to subcutaneous implantation. Methods of identifying a subcutaneously implanted access port are also disclosed. For example, a subcutaneously implanted access port may be provided and at least one feature of the subcutaneously implanted access port may be perceived. Further, the subcutaneously implanted access port may be identified in response to perceiving the at least one feature.

Abstract: A guidance system for assisting with the insertion of a needle into a patient body utilizing ultrasound imaging or other suitable imaging technology. The guidance system can include an imaging device including a probe for producing an image of an internal body portion target, such as a blood vessel. One or more sensors can be included with the probe. The sensors can sense a detectable characteristic related to the needle, such as a magnetic field of a magnet included with the needle. The system can include a processor that uses data relating to the sensed characteristic to determine a 3-D position of the needle. The system can include a display for depicting the position of the needle. A needle assembly including a hub, cannula, and magnetic element is also disclosed, wherein a magnetic axis of the magnetic element is configured to be coaxially aligned with the needle cannula.

Abstract: A probe cap for use with an ultrasound probe including a head portion and an acoustic surface is disclosed. In one embodiment, the probe cap includes a body that defines a cavity sized for releasably receiving the head portion of the probe therein. The probe cap body further defines a hole that is proximate the acoustic surface of the head portion. A compliant spacer component is disposed in the hole. The spacer component can include a hydrogel and provides an acoustic path between the acoustic surface and a tissue surface of a patient. The spacer component includes a skin contact surface that defines a concavity and is deformable against the tissue surface. Additional embodiments disclose various probe cap and accompanying needle guide designs for use in assisting a clinician with ultrasound probe use and needle insertion into a patient.

Abstract: A procedure kit that removably retains components to be used during a medical procedure, such as the insertion of a catheter into a patient, is disclosed. The procedure kit is securable to a surface or structure such that the kit is positioned as desired by the clinician, thus minimizing chances that the kit will fall to the ground or undesirably move. In one embodiment, the procedure kit comprises a body defining a plurality of pockets that are sized to removably receive therein components for use in the medical procedure, an openable flap that covers at least a portion of the pockets; and an adhesive portion included on a portion of the body to enable the procedure kit to be secured to a structure or surface proximate to the patient, such as the sterile drape covering the patient.

Abstract: A catheter assembly including one or more conductive pathways to assist with placement of the catheter assembly into a patient's vasculature by enabling ECG signals emanating from the patient's heart to be detected. The conductive pathways can be configured to reconfirm via ECG signal detection proper placement of the catheter assembly at a time subsequent to initial catheter placement into the vasculature. The catheter assembly can include a catheter hub, a catheter tube coupled to the catheter hub, the catheter tube including at least one lumen, and an outer conductive pathway disposed on an outer surface of the catheter tube and the hub. The outer conductive pathway can have a distal end located distal to a portion of the catheter tube at a skin insertion site when the catheter tube is inserted into a patient.

Abstract: A guidance system for assisting with the insertion of a needle into a patient body is disclosed. The guidance system utilizes ultrasound imaging or other suitable imaging technology. In one embodiment, the guidance system comprises an imaging device including a probe for producing an image of an internal body portion target, such as a vessel. One or more sensors are included with the probe. The sensors sense a detectable characteristic related to the needle, such as a magnetic field of a magnet included with the needle. The system includes a processor that uses data relating to the sensed characteristic to determine a 3-D position of the needle. The system includes a display for depicting the position of the needle. The needle can include a donut-shaped magnet disposed about the needle cannula, or a removable stylet with a magnetic element and a strain gauge for detection of the needle distal tip.

Abstract: A medical device-placing system includes an ultrasound probe, a medical-device detector, a console, and an alternative-reality headset. The ultrasound probe is configured to emit ultrasound signals into a patient's limb and receive echoed ultrasound signals from the patient's limb. The medical-device detector is configured for placement about the patient's limb. The console is configured to transform the echoed ultrasound signals to produce ultrasound-image segments corresponding to anatomical structures of the patient's limb, as well as transform magnetic-sensor signals from the medical-device detector into location information for a magnetized medical device within the patient's limb. The alternative-reality headset includes a display screen through which a wearer of the alternative-reality headset can see the patient's limb.

Abstract: A catheter placement system includes a catheter assembly, an external ultrasound probe, a tip location sensor, and a console. The catheter assembly includes a catheter, a magnetic component producing a magnetic field, and an electrocardiogram (ECG) sensor designed to measure an intravascular ECG signal. The external ultrasound probe includes user input controls. The tip location sensor is configured to detect the magnetic field of the magnetic component when the catheter is disposed in the patient, the magnetic field providing magnetic field information for locating the magnetic component relative to the tip location sensor, and to receive the intravascular ECG signal from the ECG sensor. The console is coupled to the tip location sensor and includes a processor and a display. The display is configured to show an image from the external ultrasound probe, a graphical representation of the magnetic component, and successive ECG waveforms detected by the ECG sensor.

Abstract: A guidance system for assisting with the insertion of a needle or other medical component into the body of a patient is disclosed. The guidance system utilizes ultrasound imaging or other suitable imaging technology. In one embodiment, the guidance system comprises an imaging device including a probe for producing an image of an internal body portion target, such as a vessel. One or more sensors are included with the probe. The sensors sense a detectable characteristic related to the needle, such as a magnetic field of a magnet included with the needle. The system includes a processor that uses data relating to the detectable characteristic sensed by the sensors to determine a position and/or orientation of the needle in three spatial dimensions. The system includes a display for depicting the position and/or orientation of the needle together with the image of the target.