Abstract: A method for making a catheter. The method includes forming a catheter tube including an outer wall circumscribing at least one lumen and having a closed distal end, and creating a slit valve in a distal segment of the catheter tube proximal of the closed distal end. The slit valve includes a slit through the outer wall and a compliant segment designed to facilitate inward deflection of a portion of the outer wall along the slit when negative pressure is applied to the at least one lumen. The compliant segment is circumferentially spaced apart from the slit.

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: An ultrasound imaging system includes an interventional medical device having a first tracking element that generates tip location data based on a locator field. An ultrasound probe has an ultrasound transducer mechanism and a second tracking element. The ultrasound transducer mechanism has an active ultrasound transducer array that generates two-dimensional ultrasound slice data at any of a plurality of discrete imaging locations within a three-dimensional imaging volume. The second tracking element generates probe location data based on the locator field. A processor circuit is configured to execute program instructions to generate an ultrasound image for display, and is configured to generate a positioning signal based on the tip location data and the probe location data to dynamically position the active ultrasound transducer array so that the two-dimensional ultrasound slice data includes the distal tip of the interventional medical device.

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 method of generating a 3D ultrasound image includes acquiring a 3D volumetric data set corresponding to a 3D imaging volume of an ultrasound probe in a 3D detection volume; acquiring a position of the ultrasound probe with respect to the 3D detection volume; acquiring a position of an interventional medical device with respect to the 3D detection volume; determining a position of the interventional medical device relative to the 3D imaging volume of the ultrasound probe; determining an interventional medical device-aligned plane that intersects with a longitudinal axis of the interventional medical device; extracting a texture slice from the 3D imaging volume for a corresponding interventional medical device-aligned plane positional and rotational orientation; mapping the texture slice onto the interventional medical device-aligned plane; and rendering the interventional medical device-aligned plane as a 3D ultrasound image and displaying the rendered 3D ultrasound image on a display screen.

Abstract: An access port for subcutaneous implantation is typically connected to a catheter, a distal portion of which is disposed within a vein or other vessel of the patient. The access port described herein is configured with enhanced fluid handling features to improve fluid flow therethrough while reducing the likelihood of clotting or occlusions in the attached catheter, thus improving system patency. The access port includes a body defining a reservoir, a needle-penetrable septum covering the top opening of the reservoir, a stem including a lumen in fluid communication with the reservoir, and a volume control device positioned in the reservoir. The volume control device includes a floor designed to move from a first position below the side opening to a second position adjacent the bottom surface, and a spring element positioned between the floor and the bottom surface, the spring element biasing the floor in the first position.

Abstract: A low-profile access port for subcutaneous implantation within a patient. The access port can include a set of receiving cups which can be placed in fluid communication with a catheter. The set of receiving cups can provide a greater skin surface with which to access the port to avoid repeated penetrations at a single locus, such as during consecutive dialysis treatments. The access port can alternatively include needle penetrable arms or elongate chambers that also have a slim, low profile. The access port can include a needle guide to direct subsequent needle access to different insertion points to permit healing at the previous insertion points. The access port can be formed of a modular construction with a first conduit, a second conduit, and an outer shell. The outer shell can include a proximal portion and a distal portion. The access port can include a stem assembly and a locking member.

Abstract: Provided herein is a system including, in some embodiments, a streamlined port and a port tunneler. The port includes a septum and a stabilizing element. The septum is disposed over a cavity in a body of the port, and the septum is configured to accept a needle therethrough. The stabilizing element is configured to stabilize the port in vivo and maintain needle access to the septum. The port tunneler includes an adapter and a release mechanism. The adapter is in a distal end portion of the port tunneler, and the adapter is configured to securely hold the port while subcutaneously tunneling the port from an incision site to an implantation site for the port. The release mechanism is configured to release the port from the adapter at the implantation site for the port.

Abstract: A low-profile access port for subcutaneous implantation within a patient. The access port can include a set of receiving cups which can be placed in fluid communication with a catheter. The set of receiving cups can provide a greater skin surface with which to access the port to avoid repeated penetrations at a single locus, such as during consecutive dialysis treatments. The access port can alternatively include needle penetrable arms or elongate chambers that also have a slim, low profile. The access port can include a needle guide to direct subsequent needle access to different insertion points to permit healing at the previous insertion points. The access port can be formed of a modular construction with a first conduit, a second conduit, and an outer shell. The outer shell can include a proximal portion and a distal portion. The access port can include a stem assembly and a locking member.

Abstract: In one aspect, a system for endovascular treatment of a blood vessel includes a control unit, an ultrasound device, an actuator, and a catheter having a treatment portion. The ultrasound device is communicatively coupled to the control unit. The ultrasound device includes an ultrasound probe having a subject contact surface. The actuator is coupled to the ultrasound probe and is operable to move the subject contact surface of the ultrasound prove relative to a treatment zone of a subject. The control unit is configured to determine a position of the treatment portion of the catheter as the catheter is advanced through the blood vessel, and move the subject contact surface of the ultrasound probe relative to the treatment zone of the subject with the actuator to follow the position of the catheter as the catheter is advanced through the blood vessel.

Abstract: Systems and methods for assisting the placement of a catheter within the body of a patient through the use of an ultrasound imaging system are disclosed. In particular, the systems and methods described herein enable a clinician to determine, prior to insertion of the medical device, how much of the device will be disposed within the vessel, thus enabling the clinician to choose a catheter with suitable length. In one embodiment, an ultrasound imaging system for assisting with placement of the medical device comprises a console, a probe for producing an image of a target location, and a processor. The processor provides to a user proximity information relating to the anticipated proximity of the medical device to the target location prior to insertion of the medical device. A display is included for depicting the image, target location depth, and the proximity information of the medical device to the target location.

Abstract: A guidance system utilizes ultrasound imaging or other suitable imaging technology. In one embodiment, the guidance system includes an imaging device including a probe for producing an image of an internal body portion target, such as a vessel. One or more sensors may be associated with the probe. The system may include a medical device, such as a needle, separate from the probe, the medical device having a magnetic field associated therewith. The system may include a processor that uses data relating to the magnetic field sensed by the one or more sensors to determine a position and/or orientation of the medical device. The system may also include a display that shows an image of the internal body portion target taken by the ultrasound imaging probe and a depiction of the medical device positioned and/or oriented with respect to the image.

Abstract: An insertion device to assist in accessing an access port that has been subcutaneously implanted in the body of a patient is disclosed. The implanted access port is accessed by a needle of a needle assembly, such as a needle-based infusion set. The insertion device may include a body having a stabilizing portion and a guide portion. The stabilizing portion stabilizes a position of the implanted access port when the body is placed on the skin of the patient atop the implanted access port. The guide portion is designed to guide a needle of the needle assembly along a predetermined path such that the needle transcutaneously pierces a septum of the implanted access port.

Abstract: A guidance system utilizes ultrasound imaging or other suitable imaging technology. In one embodiment, the guidance system includes an imaging device including a probe for producing an image of an internal body portion target, such as a vessel. One or more sensors may be associated with the probe. The system may include a medical device, such as a needle, separate from the probe, the medical device having a magnetic field associated therewith. The system may include a processor that uses data relating to the magnetic field sensed by the one or more sensors to determine a position and/or orientation of the medical device. The system may also include a display that shows an image of the internal body portion target taken by the ultrasound imaging probe and a depiction of the medical device positioned and/or oriented with respect to the image.

Abstract: Disclosed herein is an implantable port and an implantable port-detecting device (“IPDD”). The implantable port includes a housing and a septum over a portion of the housing. At least one of the housing or the septum incorporates a contrast agent for locating the septum of the implantable port when the implantable port is implanted in a patient. The IPDD includes a light source, a light detector, and a display configured to display a presence of the implantable port. The light source is configured to emit light in a near-infrared (“NIR”) range of wavelengths as incident light for absorption by the contrast agent. The light detector is configured to detect light in the NIR range of wavelengths including luminescent light emitted by the contrast agent. The display is configured to display a presence of the implantable port when the luminescent light from the contrast agent is detected by the light detector.

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: An ultrasound imaging system includes an interventional medical device having a first tracking element that generates tip location data based on an EM locator field. An ultrasound probe has an ultrasound transducer mechanism and a second tracking element. The ultrasound transducer mechanism has an active ultrasound transducer array that generates two-dimensional ultrasound slice data at any of a plurality of discrete imaging locations within a three-dimensional imaging volume. The second tracking element generates probe location data based on the EM locator field. A processor circuit is configured to execute program instructions to generate an ultrasound image for display, and is configured to generate a positioning signal based on the tip location data and the probe location data to dynamically position the active ultrasound transducer array so that the two-dimensional ultrasound slice data includes the distal tip of the interventional medical device.

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: An access port for subcutaneous implantation is typically connected to a catheter, a distal portion of which is disposed within a vein or other vessel of the patient. The access port described herein is configured with enhanced fluid handling features to improve fluid flow therethrough while reducing the likelihood of clotting or occlusions in the attached catheter, thus improving system patency. The access port includes a body defining a reservoir, a needle-penetrable septum covering the top opening of the reservoir, a stem including a lumen in fluid communication with the reservoir, and a volume control device positioned in the reservoir. The volume control device includes a floor designed to move from a first position below the side opening to a second position adjacent the bottom surface, and a spring element positioned between the floor and the bottom surface, the spring element biasing the floor in the first position.