Abstract: Methods and apparatus useful for monitoring fluid flow past a gastric restriction device using noninvasive means are described. Some methods involve the use of acoustic energy, e.g., Doppler ultrasound, to monitor the passage of fluid past the restriction device, and apparatus to detect the acoustic energy. In some embodiments the method detects a sound-producing fluid using a microphone, stethoscope, or ultrasound probe and detector combination. In some embodiments, there are described methods of using Doppler ultrasound to monitor the flow of a fluid through a stomal opening, allowing a flow condition, e.g., a flow rate, to be determined, so that a physician can accurately adjust the gastric restriction device.

Abstract: A gastrointestinal implant system includes an adjustable restriction device having a contact surface configured for at least partially engaging a surface of a gastrointestinal tract of a mammal. The implant system further includes an implantable interface including a first driving element, the first driving element being moveable and operatively coupled to the adjustable restriction device by an actuator configured to change the dimension or configuration of the contact surface in response to movement of the first driving element. The system also includes an external adjustment device having a second driving element configured to non-invasively engage the first driving element of the implantable interface from a location external to the mammal. In the system, actuation of the second driving element of the external adjustment device produces movement in the first driving element of the implantable interface and results in a change in the dimension or configuration of the contact surface.

Abstract: A liquid embolic delivery system is provided for trapping an injected liquid embolic composition to prevent the liquid embolic from solidifying or otherwise passing outside of an embolization area. The delivery system includes a catheter for delivery of a liquid embolic composition and a containment member positioned at a distal end of the catheter which is shaped to trap the liquid embolic composition delivered through the lumen of the catheter. The containment member is formed as a brush, nest, sponge, swab, flexible sack, or other shape into and around which the liquid embolic composition is injected. The liquid embolic composition is trapped or meshes with the containment member during solidification containing the liquid embolic and preventing the embolic composition from passing into the blood stream.

Abstract: A hand-operated intracardiac echocardiography (ICE) catheter is described for flexed and rotational steering is described for improved catheter operation, control and less trauma on patients. The disclosed catheter assembly includes ultrasound transducers mounted upon a rotatable tip mounted on a distal end of a flexible elongate shaft. A set of steering lines are controlled by a steering actuator to articulate bidirectionally a distal segment of the catheter. Another steering actuator controls rotation of a torque member that, in turn is coupled to the rotatable tip. A user, through the steering actuators, affects repositioning the ultrasonic transducers by repositioning exposed control surfaces of the steering actuators lengthwise along the housing of the handle.

Abstract: A method and system are disclosed for creating, in a coordinated manner, graphical images of a body including vascular features from a combination of image data sources. The method includes initially creating an angiographic image of a vessel segment. The angiographic image is, for example, either a two or three dimensional image representation. Next, a vessel image data set is acquired that is distinct from the angiographic image data. The vessel image data set comprises information acquired at a series of positions along the vessel segment. An example of such vessel image data is a set of intravascular ultrasound frames corresponding to circumferential cross-section slices taken at various positions along the vessel segment. The angiographic image and the vessel image data set are correlated by comparing a characteristic rendered independently from both the angiographic image and the vessel image data at positions along the vessel segment.

Abstract: The present invention provides for pleated bags used with interventional pullback systems, including imaging catheters such as IVUS catheters, as well as for use with other catheters. An exemplary pleated bag of the present invention may be an elongate, sterile bag, having a plurality of pleats near the distal end, and including an orifice proximal to the pleats designed to allow passage of a catheter into the bag. The present invention also provides for a system that includes a pullback device, catheter, and pleated bag. The present invention allows for improved imaging catheter procedures at reduced costs.

Abstract: An ultrasound catheter is described herein for insertion into a cavity such as a blood vessel to facilitate imaging within a vasculature. The catheter comprises an elongate flexible shaft, a capacitive microfabricated ultrasonic transducer, and a sonic reflector. The elongate flexible shaft has a proximate end and a distal end. A capacitive microfabricated ultrasonic transducer (cMUT) is mounted to the shaft near the distal end. The reflector is positioned such that a reflective surface redirects ultrasonic waves to and from the transducer. In other embodiments, the catheter comprises a plurality of cMUT elements and operates without the use of reflectors. In further embodiments, integrated circuitry is incorporated into the design.

Abstract: A system and method for providing a vascular image are disclosed wherein a single composite display simultaneously provides a first view of a patient including an angiogram image and a second view including an intravascular image rendered from information provided by an imaging probe mounted on a distal end of a flexible elongate member. A cursor, having a position derived from image information provided by a radiopaque marker proximate the imaging probe, is displayed within the angiogram image to correlate the position of the imaging probe to a presently displayed intravascular image and thus provide an easily discernable identification of a position within a patient corresponding to a currently displayed intravascular image. The resulting composite display simultaneously provides: an intravascular image that includes information about a vessel that is not available from an angiogram and a current location within a vessel of a source of intravascular image data from which the intravascular image is rendered.

Abstract: The present invention provides for an improved combination sensor tip that includes a pressure sensor and a second sensor other than a pressure sensor, both disposed at or in close proximity to the distal end of the combination sensor tip. The present invention also provides for an improved connector to couple a guide wire to a physiology monitor that reduces torsional resistance when maneuvering the guide wire.

Abstract: The present invention provides for an improved combination sensor tip that includes an ultrasound transducer and a pressure sensor both disposed at or in close proximity to the distal end of the combination sensor tip. The present invention also provides for an improved connector to couple a guide wire to a physiology monitor that reduces torsional resistance when maneuvering the guide wire.

Abstract: A catheter according to the present invention includes a multiple lumen catheter for delivery of a liquid embolic composition through a first lumen and delivery of a solidification agent through a second lumen. The catheter allows adjustment of the relative longitudinal position of the two lumens to control the solidification of the embolic composition within a blood vessel. The multiple lumen catheter system is used by inserting the catheter endovascularly into an aneurysm site and injecting a liquid embolic composition through the first lumen while injecting a solidification agent through the second lumen to wash the area of the aneurysm of blood which has become saturated with solvent, while replacing it with a fresh solidification agent.

Abstract: A catheter is adapted to exchange heat with a body fluid, such as blood, flowing in a body conduit, such as a blood vessel. The catheter includes a shaft with a heat exchange region disposed at its distal end. This region may include hollow fibers which are adapted to receive a remotely cooled heat exchange fluid preferably flowing in a direction counter to that of the body fluid. The hollow fibers enhance the surface area of contact, as well as the mixing of both the heat exchange fluid and the body fluid. The catheter can be positioned to produce hypothermia in a selective area of the body or alternatively positioned to systemically cool the entire body system.

Abstract: An indwelling heat exchange catheter with integrated temperature sensor includes a catheter tube. A closed loop heat exchanger extends from the catheter tube. A temperature sensor can be integrally formed with the catheter tube such that it is insulated from the closed loop heat exchanger. The indwelling heat exchange catheter can further include a guide-wire tube that extends from the catheter tube and in such a case, the temperature sensor can be affixed to the guide-wire tube. Alternatively, a wire can extend through the catheter tube and the temperature sensor can be affixed to the wire.

Abstract: A flexible thermography catheter which includes an elongated body having a proximal end, a distal end, and a distal section, an expandable body comprising at least one independently movable support arm located at the distal section of the elongated body, at least one support arm retainer positioned on the distal section of the elongated body, and at least one sensor positioned on at least one of the distal section, the expandable body, and the at least one support arm. The at least one support arm retainer is configured to independently secure at least one section of the at least one support arm to the distal section of the elongated body in independently movable relation to each of the at least one support arm and the elongated body.

Abstract: A catheter according to the present invention includes a multiple lumen catheter for delivery of a liquid embolic composition through a first lumen and delivery of a solidification agent through a second lumen. The catheter allows adjustment of the relative longitudinal position of the two lumens to control the solidification of the embolic composition within a blood vessel. The multiple lumen catheter system is used by inserting the catheter endovascularly into an aneurysm site and injecting a liquid embolic composition through the first lumen while injecting a solidification agent through the second lumen to wash the area of the aneurysm of blood which has become saturated with solvent, while replacing it with a fresh solidification agent.

Abstract: A catheter according to the present invention includes a multiple lumen catheter for delivery of a liquid embolic composition through a first lumen and delivery of a solidification agent through a second lumen. The catheter allows adjustment of the relative longitudinal position of the two lumens to control the solidification of the embolic composition within a blood vessel. The multiple lumen catheter system is used by inserting the catheter endovascularly into an aneurysm site and injecting a liquid embolic composition through the first lumen while injecting a solidification agent through the second lumen to wash the area of the aneurysm of blood which has become saturated with solvent, while replacing it with a fresh solidification agent.

Abstract: A catheter and a method of using the catheter are disclosed that serve to create an efficient and rapid controlled manner of regulating a patient's body temperature. The catheter is a heat exchange catheter insertable into a blood vessel of a patient, circulating a heat exchange fluid therein, and including a spiral-shaped inflatable balloon that mixes laminar layers of the heat exchange fluid flowing inside the balloon.

Abstract: A heat exchange catheter has a catheter body with an inflow lumen, an outflow lumen, and an infusion lumen. A first heat exchange balloon helically wraps around at least a portion of the catheter body in fluid communication with the inflow lumen. A second heat exchange balloon helically wraps around at least a portion of the catheter body in fluid communication with the outflow lumen. The first and second balloons form a gap there between to facilitate infusion of fluid into the blood stream of the patient via an infusion port formed within the gap.

Abstract: A heat exchange catheter has a catheter body with an inflow lumen, an outflow lumen, and an infusion lumen. A first heat exchange balloon helically wraps around at least a portion of the catheter body in fluid communication with the inflow lumen. A second heat exchange balloon helically wraps around at least a portion of the catheter body in fluid communication with the outflow lumen. The first and second balloons form a gap there between to facilitate infusion of fluid into the blood stream of the patient via an infusion port formed within the gap.

Abstract: Catheters including a rugged, reusable proximal body and a disposable distal body attached by a releasable connection are provided. The reusable proximal body is constructed from resterilizable materials such as glass, metal alloys and engineering plastics. The disposable distal body, designed for one-time use, is made from reliable but inexpensive materials. The catheters may be dilatation catheters and may be manufactured in any configuration, including rapid exchange, balloon-on-a-wire, and over-the-wire designs with single or multiple lumens. The modular construction of the catheter and releasable connection provides for rapid and easy changes in the configuration and balloon size depending on the needs of the medical procedure.