Abstract: A balloon for medical treatments such as percutaneous transluminal coronary angioplasty (PTCA), delivery of a vascular stents or stent grafts, employs reinforcement materials that are patterned so as to promote consistent folding of the balloon. Also disclosed are methods and apparatus for biocidal treatment using a balloon, including balloons with fiber fabric reinforcements.

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: Invasive medical devices including a substantially non-eluting antimicrobial treatment are disclosed. One or more external and/or internal surfaces of the medical device include a substantially non-eluting copper-coated surface that assists in preventing microbial colonization of the coated surface. This in turn reduces the incidence of infection to the patient originating from the medical device. In one embodiment, a catheter assembly is disclosed and comprises an elongate catheter tube that defines at least one lumen, at least one extension leg including a luer connector, and a bifurcation hub including at least one fluid passageway that provides fluid communication between the extension leg and the lumen. A substantially non-eluting copper coating is disposed on a surface of at least one of the lumen, the extension leg, the luer connector, and the fluid passageway. The coating is applied via an electroless deposition process. A water-shed coating is disposed on the copper coating.

Abstract: A fluid control component configured for controlling fluid flow through the hub of a catheter assembly during and after placement into the patient is disclosed. In one embodiment, the fluid control component comprises a body disposed within a cavity of the hub, the body being movable between a first position and a second position, wherein the body does not pierce a valve disposed in the hub when in the first position and wherein the body pierces the valve when in the second position. The body includes a conduit to enable fluid flow through an internal portion of the body when the body is in the second position, and a plurality of longitudinally extending ribs disposed on an exterior surface of the body. The ribs provide at least one fluid flow channel between the valve and an external portion of the body when the body is in the second position.

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: An apparatus for performing a medical procedure and, in particular, an aortic valvuloplasty, in a vessel for transmitting a flow of fluid includes a first inflatable balloon, such a perfusion balloon with a plurality of cells in a single cross-section of the balloon for permitting the fluid flow in the vessel. An inflatable valve, which may take the form of a second inflatable balloon, may be provided for controlling the fluid, flow through the first balloon when inflated. Through selective movement of the second balloon when inflated via the flow rhythms created by the beating heart, a one way valve results that can be used to mimic the natural flow created by the valve under treatment.

Abstract: Surgical instruments and their methods of use are described. In one embodiment, a surgical instrument includes a power transmission including a trigger and a fastener driver operatively coupled to the trigger. Actuation of the trigger from a first configuration to a second configuration moves the fastener driver between at least a first position and a second position. Additionally, an actuation lockout system operatively associated with the power transmission is moveable between a locked configuration and an unlocked configuration. The actuation lockout system prevents movement of the fastener driver from the first position to the second position when the actuation lockout system is in the locked configuration. Actuation of the trigger from the first configuration towards the second configuration moves the actuation lockout system from the locked configuration to the unlocked configuration.

Abstract: A vascular occlusion treatment system includes an ultrasound imaging system having an imaging control circuit communicatively coupled to an ultrasound imaging probe and to a display screen, and an ultrasonic vibration system having an ultrasonic generator operatively coupled to a medical ultrasonic object, such as an ultrasonic catheter. The ultrasonic catheter has a corewire with a distal tip. The ultrasonic generator has a generator control circuit that alternatingly switches between an ultrasonic work frequency and a tracking frequency. The generator control circuit sends a notification to the imaging control circuit when the generator control circuit has switched from the ultrasonic work frequency to the tracking frequency. The imaging control circuit responds by initiating a search in an ultrasound imaging space to locate the distal tip that is vibrating at the tracking frequency, and indicating a location of the distal tip in the ultrasound image displayed on the display screen.

Abstract: Packaging for a medical implant such as a hernia repair prosthetic material includes a carrier and a stiffener. The hernia repair prosthetic material is placed adjacent to the stiffener within the carrier. The carrier assembly is sealed within an outer pouch, such as a foil pouch, and sterilized. When the carrier is being removed from the pouch in preparation for surgery, the stiffener helps prevent the carrier assembly from contacting non-sterile portions of the pouch.

Abstract: An improved medical procedure or catheterization tray included in an improved medical procedure or catheterization package. The improved medical procedure or catheterization tray is intuitively arranged and includes instructions printed thereon to improve the medical procedure or catheterization implementation and results. In one example, a catheterization package and catheterization tray has a layout and/or arrangement of components that may help reduce CAUTI rates by facilitating ease of use and aiding in proper aseptic technique during insertion. The medical procedure or catheterization package and/or medical procedure or catheterization tray may include various implements, compartments, and components necessary and/or helpful to the medical procedure or catheterization, including, for example, improved swabs and an improved compartment for holding the swabs.

Abstract: An apparatus for performing a medical procedure includes a balloon comprising an inflatable body. A first releasable or frangible connection is provided to maintain the body at a first diameter up to a first inflation pressure, and to release, such as by disconnecting, and thus allow the body to assume a second diameter, such as at a second inflation pressure greater than the first inflation pressure or upon a manual release of the connection by a clinician. Multiple releasable or frangible connections may be provided, including between portions (folds) of the inflatable body of the balloon. This disclosure also pertains to a non-compliant or semi-compliant balloon having a first inflation diameter corresponding to a first range of inflation pressures and a second inflation diameter corresponding to a second inflation pressure greater than the first range of inflation pressures.

Abstract: An antimicrobial catheter assembly can include a hub, a catheter tube connected to the hub, at least one extension leg connected to the hub, and a non-eluting antimicrobial coating on an internal or external surface of the catheter assembly. The hub includes at least one hub lumen defining a corresponding hub portion of a fluid pathway through the catheter assembly. The catheter tube includes at least one catheter-tube lumen defining a corresponding catheter-tube portion of the fluid pathway through the catheter assembly. The extension leg can include an extension-leg lumen defining a corresponding extension-leg portion of the fluid pathway through the catheter assembly. The antimicrobial coating can include a copper-based layer between a corrosion-preventing layer and the internal or external surface of the catheter assembly, an adhesion-promoting layer between the copper-based layer and the internal or external surface of the catheter assembly, or a combination thereof.

Abstract: Provided herein is a catheter assembly including, in some embodiments, a core wire configured for linear actuation and a damping mechanism around the core wire. The core wire includes a proximal end with a sonic connector configured to couple to an ultrasound-producing mechanism. The core wire includes a distal end configured to modify intravascular lesions with vibrational energy from the ultrasound-producing mechanism. The damping mechanism includes a gasket system and a retainer to retain the gasket system in a damping-mechanism bore of the catheter assembly. The damping mechanism is around a proximal-end portion of the core wire, where the damping system can provide a compressive force sufficient to dampen transverse wave-producing vibrational energy in the proximal-end portion of the core wire without restricting the linear actuation of the core wire through the damping mechanism including extension and retraction of the core wire through the damping mechanism.

Abstract: A catheter assembly including, in some embodiments, a sonic connector at a proximal end of a core wire, a damping mechanism around a proximal end portion of the core wire, and a heat sink connected to the damping mechanism. The sonic connector is configured to couple to an ultrasound-producing mechanism and transmit vibrational energy to the proximal end of the core wire, which core wire includes a distal end portion configured to modify intravascular lesions. The damping mechanism includes a gasket system around the proximal end portion of the core wire in a damping-mechanism bore of the catheter assembly. The damping mechanism is configured to damp the vibrational energy. A system including, in some embodiments, the catheter assembly and the ultrasound-producing mechanism is also disclosed.

Abstract: An integrated catheter placement system for placing a catheter in a vasculature of a patient. The system includes a system console with a tip location mode and an ultrasound mode viewable on a display, a magnetic assembly emanating a magnetic field, a tip location sensor designed to sense the magnetic field, and an ultrasound probe for ultrasonically imaging an internal portion of the patient. The magnetic field may provide magnetic field information for locating the magnetic assembly relative to the tip location sensor. The tip location sensor is designed to communicate the magnetic field information to the system console. The system console is designed to display an icon representative of a location of the magnetic assembly relative to the tip location sensor in the tip location mode.

Abstract: A repair prosthetic for repairing a hernia is disclosed. In some embodiments, the repair prosthetic includes a patch body, a frame that assists in spreading the patch body from a reduced configuration to an expanded configuration, and a plurality of tethers attached to the patch body at locations between the frame and a periphery of the patch body. In various embodiments, the tethers can be tensioned to mitigate curling or creasing in the patch body to flatten the patch to facilitate attachment to tissue.

Abstract: A medical balloon with a variable diameter that is reinforced with continuous fibers woven to form a fabric with a varying number of layers and fiber densities. Portions of the balloon having a relatively smaller diameter are reinforced with a fabric having a reduced fiber density and an increased number of layers to facilitate the placement of the layers. The fabric also includes a braiding pattern that facilitates the transition from a single layer fabric to a multiple layer fabric. Also described is a manufacturing method for the braiding and layering.

Abstract: Embodiments disclosed herein are directed to apparatus and methods for automatic fluid flow system connectors. The system generally includes a load cell interface coupled to a console and a ring connector coupled to a fluid collection system. The ring connector can be releasably engaged with the load cell using a push-button actuated locking mechanism. Embodiments of the locking mechanism can include a latch and aperture engagement, a shelf and ledge engagement, or a track and channel engagement, or combinations thereof. The ring connector and load cell can include electrical contacts configured to engage along an axis that extends perpendicular to a surface on which the electrical contacts are disposed. This is believed to reduce wear on the electrical contacts, thereby extending the usable life of the system.

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.