Abstract: A balloon protector is disclosed for use with a balloon catheter including a shaft and a drug-coated balloon. The balloon protector includes a balloon-covering section configured to cover the drug-coated balloon with a running clearance fit, and a shaft-covering section coupled to the balloon-covering section. The shaft-covering section is configured to contact at least a portion of the shaft in a sliding or location clearance fit. The shaft-covering section is configured to separate from the shaft without separating from the balloon-covering section to permit translation of the balloon-covering section from a first position over the drug-coated balloon to a second position over the shaft-covering section. A catheter assembly with the balloon protector and methods of use are also disclosed.

Abstract: Devices and methods for delivery or retrieval of a distal protection device. A distal protection assembly may comprise an outer sheath, an inner shaft disposed within a lumen of the outer sheath, a distal protection device disposed at a distal end of the inner shaft; and a manifold coupled to a proximal end of the outer sheath that is adapted for moving the outer sheath relative to the inner shaft.

Abstract: Disclosed is a manifold including a housing having multiple ports and multiple bores networking the ports. An actuatable valve, such as a slidable valve, including one or more bores may be positioned in the housing such that the valve is actuatable between a first position and a second position. Actuation of the valve may selectively establish a desired fluid pathway through the manifold. One or more seals may be interposed between the valve and the housing. The seal includes at least a first sealing element, a second sealing element, and a land extending between the sealing elements. The sealing elements are configured to provide a fluid tight seal between the housing and the valve when the valve is in either the first or second position, and the land is configured to provide a fluid tight seal between the housing and the valve when the valve is in an intermediate position.

Abstract: Embolic protection sheath and method of using the same. In some embodiments, the present invention includes an elongate shaft, an embolic protection filter coupled to the shaft, and a sheath disposed over at least a portion of the shaft.

Abstract: The present invention relates generally to the field of embolic protection and, more particularly, to systems for locking a shaft relative to a hub assembly. In addition, a method for securing a shaft relative to a hub assembly is disclosed.

Abstract: A fluid injection system is disclosed The system is adapted to employ first and second injectors which may sequentially, or simultaneously, inject first and second fluids into a patient via a catheter. The first and second injectors may be power actuated. The actuation of the injectors may be controlled via a controller of the system. The user may be provided with an operator interface module to enable the control of the system to be affected during operation. A separate waste line may be provided to drain the system effectively and efficiently. A pressure sensor may be provided proximate the catheter to reduce pressure signal wave dampening and fluid waste.

Abstract: A pressure relief mechanism is incorporated into a modified syringe-type inflation device that may be coupled to a balloon catheter for inflating and deflating the balloon. An engagement mechanism selectively engages and disengages from a threaded shaft for advancing or withdrawing a plunger placed in slidable, yet sealing fit within a cylindrical chamber. In a first engaging position, the threaded shaft may be forcibly advanced or withdrawn in the cylindrical chamber, while in a second disengaged position, the plunger may be quickly pulled back.

Abstract: A number of devices are illustrated for providing a manifold that can simply and selectively couple a number of different therapeutic and diagnostic elements to a catheter or other medical device. Some examples include devices having sliding actuators, rotary actuators, button actuators, or combinations thereof, for easily changing the valve scheme and fluid pathways within a manifold.

Abstract: Medical devices for removing gasses, such as gas bubbles and/or dissolved gasses, from a liquid to be delivered to a patient, and methods of use and making of such devices. In at least some embodiments, a gas permeable membrane material is used in the construction of the gas removal devices. In some embodiments, layers of gas permeable membrane material are used to construct a filter structure for removing gas from the liquid. In other embodiments, hollow tubes and/or fibers of the gas permeable membrane material are used to construct a filter structure for removing gas from the liquid. The gas removal devices may be used in any of a broad variety of liquid delivery systems and/or configurations.

Abstract: A fluid injection apparatus and method of injecting fluid are disclosed. The apparatus includes a control syringe electrically connected to a power-actuated syringe. A sensor is provided proximate the control syringe to monitor the position of the plunger therein, with a signal representative of plunger position then being communicated to a processor for calculation of a corresponding control signal. The control signal is received by an actuator of the power-actuated syringe to move the plunger of the power-actuated syringe in a manner related to movement of the control syringe. The control syringe is provided with a feedback device to provide the operator with an indication as to the pressure of the fluid being injected into a patient.

Abstract: A pressure activated valve for a three-way connection between a catheter, an injector and a pressure transducer is disclosed. The valve includes a body that has an inlet for connection to an injector, an outlet for connection to a catheter and a secondary connection for connection to a pressure transducer. The body also includes a seal seat disposed between the secondary connection in both the inlet and the outlet. The body is flexibly connected to a plug seal. The plug seal is disposed between the seal seat in both the inlet and the outlet. The plug seal is movable between an open position spaced apart from the seal seat and biased towards the inlet and the outlet and a closed position against the seal seat thereby isolating the secondary connection from both the inlet and the outlet.

Abstract: The present invention is drawn to a valve control accessory for use with a dual balloon stent delivery catheter. The accessory device includes a bifurcated fluid line adapted to connect to an inflation device using a proximal luer connector. Additional luer connectors at the distal ends of the main fluid line and branched fluid line are engaged to connect to the proximal ends of a bifurcated catheter shaft, allowing the fluid lines to be in fluid communication with a parent and sidebranch balloon respectively. In one embodiment, stopcocks are formed in both the main and sidebranch fluid lines to allow independent or simultaneous expansion of each balloon. A pressure indicator may be placed on either fluid line to indicate which line is under pressure.

Abstract: A pressure activated valve for a three-way connection between a catheter, an injector and a pressure transducer is disclosed. The valve includes a body that has an inlet for connection to an injector, an outlet for connection to a catheter and a secondary connection for connection to a pressure transducer. The body also includes a seal seat disposed between the secondary connection in both the inlet and the outlet. The body is flexibly connected to a plug seal. The plug seal is disposed between the seal seat in both the inlet and the outlet. The plug seal is movable between an open position spaced apart from the seal seat and biased towards the inlet and the outlet and a closed position against the seal seat thereby isolating the secondary connection from both the inlet and the outlet.

Abstract: An apparatus and method for manually injecting fluid into a patient with improved contrast visualization are disclosed. The apparatus includes a syringe having a cylinder in which a plunger is reciprocatingly mounted. The syringe is connected to a manifold which itself is connected to a source of radiopaque contrast. Retraction of the plunger within the cylinder draws contrast into the cylinder, and depression of the plunger forces the contrast through the manifold and into a patient through a catheter. In order to increase the speed of injection and thus the visualization of the contrast, an improved visualization device is provided which may be provided in the form of a heater or, alternatively, in the form of an expandible catheter. The heater may be positioned anywhere within the apparatus to elevate the temperature of the contrast material, which in turn reduces its viscosity and thereby increases the speed with which fluid may be injected.

Abstract: Embolic protection sheath and method of using the same. In some embodiments, the present invention includes an elongate shaft, an embolic protection filter coupled to the shaft, and a sheath disposed over at least a portion of the shaft.

Abstract: A pressure relief mechanism is incorporated into a modified syringe-type inflation device that may be coupled to a balloon catheter for inflating and deflating the balloon. An engagement mechanism selectively engages and disengages from a threaded shaft for advancing or withdrawing a plunger placed in slidable, yet sealing fit within a cylindrical chamber. In a first engaging position, the threaded shaft may be forcibly advanced or withdrawn in the cylindrical chamber, while in a second disengaged position, the plunger may be quickly pulled back.

Abstract: The present invention generally relates to a medical device and procedure for accurately positioning a catheter across a desired region within a patient's vasculature. In particular, the present invention provides a hub assembly unit that allows a physician to precisely position a stent within a vessel utilizing a stent delivery catheter. The hub assembly unit includes a fine adjustment mechanism. The fine adjustment mechanism extends or contracts the length of the hub assembly unit in controlled incremental units. These controlled fine displacements are then translated directly to the stent delivery or balloon dilation catheter.

Abstract: An apparatus and method for manually injecting fluid into a patient with improved contrast visualization are disclosed. The apparatus includes a syringe having a cylinder in which a plunger is reciprocatingly mounted. The syringe is connected to a manifold which itself is connected to a source of radiopaque contrast. Retraction of the plunger within the cylinder draws contrast into the cylinder, and depression of the plunger forces the contrast through the manifold and into a patient through a catheter. In order to increase the speed of injection and thus the visualization of the contrast, an improved visualization device is provided which may be provided in the form of a heater or, alternatively, in the form of an expandible catheter. The heater may be positioned anywhere within the apparatus to elevate the temperature of the contrast material, which in turn reduces its viscosity and thereby increases the speed with which fluid may be injected.

Abstract: A fluid injection system is disclosed. The system is adapted to employ first and second injectors which may sequentially, or simultaneously, inject first and second fluids into a patient via a catheter. The first and second injectors may be power actuated. The actuation of the injectors may be controlled via a controller of the system. The user may be provided with an operator interface module to enable the control of the system to be affected during operation. A separate waste line may be provided to drain the system effectively and efficiently. A pressure sensor may be provided proximate the catheter to reduce pressure signal wave dampening and fluid waste.

Abstract: The present invention relates generally to the field of embolic protection and, more particularly, to systems for locking a shaft relative to a hub assembly. In addition, a method for securing a shaft relative to a hub assembly is disclosed.