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.

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: In one aspect, a hydroformylation reaction process comprises contacting an olefin, hydrogen, and CO in the presence of a homogeneous catalyst in a cylindrical reactor to provide a reaction fluid, wherein the reactor has a fixed height, and wherein a total mixing energy of at least 0.5 kW/m3 is delivered to the fluid in the reactor; removing a portion of the reaction fluid from the reactor; and returning at least a portion of the removed reaction fluid to the reactor, wherein the returning reaction fluid is introduced in at least two return locations positioned at a height that is less than 80% of the fixed height, wherein the at least two return locations are positioned above a location in the reactor where hydrogen and carbon monoxide are introduced to the reactor, and wherein at least 15% of the mixing energy is provided by the returning reaction fluid.

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: A valve assembly for a fuel pump is provided. The valve assembly may include an inlet valve limited to a first range of travel extending between a fully closed position and a fully opened position of the inlet valve, a valve pin coupled to the inlet valve, an armature pin selectively engaging the valve pin, and an armature coupled to the armature pin and limited to a second range of travel extending between an engaged position and a disengaged position that is less than the first range of travel.

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.