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: 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: 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: 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: An ultrasound imaging device including the ability to determine when a component, such as a removable probe cap, is attached to a portion of an ultrasound probe. Such a cap is employed in one embodiment to act as a spacer component to provide a standoff for the probe head. Detection of probe cap attachment to the ultrasound probe enables the resultant ultrasound image to be adjusted automatically by the ultrasound imaging system. In one embodiment, an ultrasound imaging system comprises an ultrasound probe, a cap or other component that is attachable to the probe, and a component attachment detection system for detecting attachment of the component to the probe. Once the cap is detected, an aspect of an ultrasound image produced by the imaging system is modified, such as cropping the image to remove undesired portions of the cap, such as the spacer component.

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 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 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: A bi-directional valve assembly, including valves for use in closed-ended catheters or other elongate tubular devices, is disclosed. In one embodiment, a catheter assembly for insertion into a body of a patient is disclosed and comprises an elongate catheter tube including an outer wall that at least partially defines at least one lumen that extends between a proximal end and a closed distal end thereof. The catheter tube includes a valve assembly that in turn includes a linear slit valve defined through the outer wall of a distal segment of the catheter tube, and a deformation region. The deformation region includes a compliant segment disposed in the outer wall of the catheter tube and a thinned portion of the outer wall. The compliant segment and thinned portion of the deformation region cooperate to preferentially deform the outer wall and open the slit valve during aspiration through the catheter tube.

Abstract: An apparatus and 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: 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 system for identifying an attribute of an implanted medical device, such as an access port. In one embodiment, the identification system comprises a marker included with the implanted medical device, the marker relating to an attribute of the implanted medical device. An external detection device is also included, comprising a signal source that emits an incident electromagnetic signal for impingement on the marker of the implanted medical device, a detector that detects a return signal from the marker resulting from impingement of the incident electromagnetic signal, and a user interface for conveying information relating to the attribute based on detection of the return signal. In the case of an implantable access port, for instance, the described system enables information, such as the ability of the port to withstand power injection of fluids therethrough, to be ascertained even after the port has been subcutaneously implanted within the patient.

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 system for identifying an attribute of an implanted medical device, such as an access port. In one embodiment, the identification system comprises a marker included with the implanted medical device, the marker relating to an attribute of the implanted medical device. An external detection device is also included, comprising a signal source that emits an incident electromagnetic signal for impingement on the marker of the implanted medical device, a detector that detects a return signal from the marker resulting from impingement of the incident electromagnetic signal, and a user interface for conveying information relating to the attribute based on detection of the return signal. In the case of an implantable access port, for instance, the described system enables information, such as the ability of the port to withstand power injection of fluids therethrough, to be ascertained even after the port has been subcutaneously implanted within the patient.

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. In one embodiment, the insertion device comprises a body that includes 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 guides 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 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: 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: An integrated catheter placement system and method for placing a catheter in a patient body. The system may include a system console having a display, a tip location sensor operably connected to the system console and placed onto a body of a patient. The tip location sensor may be designed to sense a magnetic field of a first medical device. The system may also include an ECG tip confirmation component operably connected to the system console via the tip location sensor, and an ultrasound probe operably connected to the system console, the ultrasound probe including one or more magnetic sensors designed to sense a magnetic field of a second medical device different from the first medical device. The system may further include a processor associated with the console designed to utilize data relating to the magnetic field of the second medical device to determine a position and/or orientation thereof.

Abstract: An access port for subcutaneous implantation into a body of a patient is disclosed. The port is typically subcutaneously connected to a catheter, a distal portion of which is disposed within a vein or other vessel of the patient. The port 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. In one embodiment, for instance, an implantable access port is disclosed and comprises a body defining a reservoir, a needle-penetrable septum covering an opening to the reservoir, a stem defining an outlet to the reservoir, and a deformable element included in the reservoir. The deformable element is operably connected to a main portion of the septum and deforms in response to displacement of the septum to counteract a change in volume within the reservoir and prevent blood ingress into the catheter.

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.