Abstract: A method is disclosed for treating calcified lesions within a wall of a blood vessel. The first step includes breaking apart a calcified lesion using a plurality of shockwaves generated in an angioplasty balloon of an angioplasty catheter device. The angioplasty balloon is dilated via a fluid to a first extent to fit against at least a portion of the wall of the blood vessel. A plurality of electrical pulses are delivered to a pair of electrodes disposed within the fluid inside the balloon. The electrical pulses have an amplitude sufficient to create plasma arcs in the fluid to generate shockwaves that are conducted through the fluid and through the balloon to the blood vessel, to crack the calcified lesion. After breaking apart the calcified lesion, the angioplasty balloon is allowed to further expand to a second extent greater than the first extent, thereby expanding an opening in the blood vessel.

Abstract: An integrated therapeutic and imaging device that uses at least two balloons to provide a guarded zone that can be evacuated and replaced with a fluid that is sufficiently clear to permit optical coherence tomography (or even high resolution ultrasound) imaging that would otherwise be of poor quality or impossible. Methods of making and operating the imaging device to obtain clear, high quality images, as well as treating a patient's tissue with the device within a living body in association with obtaining an image of the patient's tissue, are included.

Abstract: Methods for placing a stent in a branched vessel include stretching the stent, aligning the stent within a target location at a branched vessel and releasing it for expansion at the target location.

Abstract: A catheter based medical device is provided for a percutaneous surgical procedure that provides forward-looking visualization and delivery of a medical device. The catheter includes a carriage at its distal end and an ultrasonic transducer is supported by the carriage. A conduit that has its proximal end disposed within the catheter and the conduit passes through the sidewall of the catheter proximate to the distal end of the catheter so that the distal end of the conduit is disposed on an exterior of the sidewall of the catheter. A medical device is deliverable through the lumen of the conduit and the ultrasonic transducer provides visualization of the medical device distally of the transducer.

Abstract: A device for the transfer of radiopaque material within the body comprises a valvuloplasty or other balloon coated with the radiopaque material. The balloon is inflated in the aortic valve for marking the site of an aortic annulus to enable accurate placement of prosthetic valves under fluoroscopic imaging.

Abstract: An integrated therapeutic and imaging device that uses at least two balloons to provide a guarded zone that can be evacuated and replaced with a fluid that is sufficiently clear to permit optical coherence tomography (or even high resolution ultrasound) imaging that would otherwise be of poor quality or impossible. Methods of making and operating the imaging device to obtain clear, high quality images, as well as treating a patient's tissue with the device within a living body in association with obtaining an image of the patient's tissue, are included.

Abstract: Catheters having expandable members, e.g., balloons, incorporating heating elements and temperature sensors for controlled delivering of energy to tissues, i.e., to treat diseases, especially hypertension. The invention also describes methods for monitoring and controlling the amount of energy delivered to the tissue.

Abstract: Disclosed herein is an integrated therapeutic and imaging catheter. The catheter comprises an inner member defining a guidewire lumen, a balloon assembly, a treatment device mounted about the balloon assembly, and an imaging device. The balloon assembly comprises an inner sleeve surrounding the inner member and a connection medium, wherein the connection medium is disposed between the balloon inner sleeve and the inner member, and an outer sleeve surrounding the inner sleeve. The imaging device is disposed distal to the balloon assembly and is coupled to the connection medium.

Abstract: At the present time, physicians often treat patients with atrial fibrillation (AF) using radiofrequency (RF) catheter systems to ablate conducting tissue in the wall of the Left Atrium of the heart around the ostium of the pulmonary veins. These systems are expensive and take time consuming to use. The present invention circular ablation system CAS includes a multiplicity of expandable needles that can be expanded around a central axis and positioned to inject a fluid like ethanol to ablate conductive tissue in a ring around the ostium of a pulmonary vein quickly and without the need for expensive capital equipment. The expansion of the needles is accomplished by self-expanding or balloon expandable structures. The invention includes centering means so that the needles will be situated in a pattern surrounding the outside of the ostium of a vein. Also included are members that limit the distance of penetration of the needles into the wall of the left atrium.

Abstract: A system and method for positioning a pill to be ingested by a user in a field of view of an image acquisition camera. The method includes the steps of determining a desired location of the mouth of a user in a field of view of an image acquisition camera, determining a current position of a pill to be ingested by the user in the field of view of the image acquisition apparatus, and indicating on a display a movement to be made by the user to move the pill towards mouth of the user.

Abstract: Described herein is an apparatus that includes an endotracheal tube or airway device having a proximal end and a distal end and an occlusion cuff. The occlusion cuff includes a sensor for helping determine proper endotracheal or airway device placement.

Abstract: The invention relates to a catheter device for treating a blockage of a vessel, with the catheter device featuring a treatment catheter for treating the vessel blockage which is embodied as an integrated unit with front-mounted stent.

Abstract: The invention relates to a medical system for introducing a catheter into a blood vessel of a patient, having a computer and control unit, a means for creating a transparent general view of the position of the vessel, a catheter with a reversible inflatable balloon located in the front area, to the outside of which a stent can be fitted for implanting into the vessel, a position locating system for the catheter with position and location sensors that can determine the position and location of the catheter, the system with at least one OCT (optical coherence tomography) sensor at a catheter end for the close-up area, with at least one IVUS (intravascular ultrasound) imaging sensor at a catheter end for the remote area and the computer and control unit having image processing and image display functions for the image sensors.

Abstract: A method and system for ultrasound treatment utilizing a multi-directional transducer to facilitate treatment, such as therapy and/or imaging or other tissue parameter monitoring, in two or more directions. In accordance with an exemplary embodiment, a multi-directional transducer comprises at least two transduction elements configured to provide for ultrasound energy, such as radiation, acoustical energy, heat energy, imaging, positional information and/or tissue parameter monitoring signals in two or more directions. The transduction elements can comprise various materials for providing ultrasound energy or radiation, such as piezoelectric materials, with and without matching layers. In addition, the transduction elements can be configured for substantially uniform, focused and/or defocused radiation patterns, as well as for single, multiple-element and/or multiple-element array configurations.

Abstract: Devices and methods for assessing the orientation and shape of vessel lumens and hollow portions of organs are described. The devices and methods are particularly adapted for determining the orientation and shape of the native heart valves to facilitate the later implantation of a prosthetic heart valve. The devices are typically catheter-based having an expandable member fixed to a distal end of the catheter. Located within the expandable member is an ultrasonic imaging probe and an acoustic reflective material. The methods typically comprise deploying the balloon percutaneously to a target location, expanding the balloon, and determining the orientation and shape of a lumen, particularly a cardiac valve.

Abstract: Devices and methods for assessing the size, shape, and topography of vessel lumens and hollow portions of organs are described. The devices and methods are particularly adapted for determining the size, shape, topography, and compliance of the native heart valves to facilitate the later implantation of a prosthetic heart valve. The devices are typically catheter-based having an assessment mechanism fixed to a distal end of the catheter. The assessment mechanism generally includes an expandable member, such as a balloon. The assessment mechanism may also include an imaging member, a physical assessment member, an electronic mapping construction, an alignment mechanism, a valvuloplasty balloon, or any combinations thereof. The methods typically comprise deploying the balloon percutaneously to a target location, expanding the balloon, and determining one or more physical parameters associated with the target location.

Abstract: An intravascular ultrasonic imaging catheter is provided with a flexible circuit electrically coupled to a transducer array mounted on the distal end of the catheter, a portion of the flexible circuit being helically wound about the catheter in order to enhance the flexibility of the circuit. The catheter may be a balloon catheter which is also provided with a stent mounted on the balloon, the stent carrying one or more drugs designed to be eluted or washed into a patient's blood stream after the stent has been delivered, by a the balloon catheter, into a target area within the patient's vascular system.

Abstract: The invention provides techniques for the diagnosis and treatment of a narrowing lumen with a smart balloon catheter. The smart balloon catheter includes pressure and diameter sensing features along with a feedback system to control the dilation of the balloon. Ambient pressure of the lumen is detected with multiple pressure sensors located on the distal end of the catheter and displayed on a monitoring device. Ambient pressure results are used to position the distal end of the catheter within the narrowing lumen. A controlled gradual, or stepwise, dilation of the balloon occurs. The pressure sensors detect the ambient pressure of the lumen outside the of the balloon, and the pressure within the balloon. Distances sensors measure the distance between the center of the catheter and the expanded balloon surface. The diameter of the balloon at different cross-sections is determined and displayed on the monitoring device. The volume of the balloon, and the waist of the narrowing lumen, are determined.

Abstract: A probe for detecting at least one property of a chronic total occlusion in a lumen. The probe includes an elongated member having a distal end configured to be inserted into the lumen, and an ultrasound transducer mounted at the distal end of the elongated member. The ultrasound transducer is configured to emit an ultrasonic signal and to receive a reflected signal from the chronic total occlusion. The probe also includes a processor configured to receive the reflected signal from the ultrasound transducer and convert the reflected signal to at least one property of the chronic total occlusion.

Abstract: Catheter device for insertion into a vessel of a human or animal body, comprising a guide catheter and, incorporated in same, an OCT catheter with an OCT imaging device, the guide catheter having a balloon inflatable via a supply line for occluding the vessel, as well as a device for delivering a liquid or gas to the vascular region to be recorded by means of the OCT imaging device, in particular the vascular region located distally to the balloon, wherein there is provided on the guide catheter a second inflatable balloon spaced apart from the first balloon for occluding the vessel, wherein the section of the guide catheter between the two balloons is transparent, at least in sections, to the OCT radiation emittable by the OCT imaging device disposed inside the guide catheter.

Abstract: Intravascular device for matching impedances of portions of an intravascular circuit and limiting RF signal-induced heating of intravascular conductors. An intravascular device includes alternating conductive and dielectric layers and an electrically conductive coil in a configuration that effects an impedance-matching circuit. Another embodiment of an intravascular device has cylindrical inner and outer walls formed of an expandable, electrically conductive material, the inner and outer walls being separated by a compressible dielectric material. Varying the pressure in the lumen defined by the inner wall changes the spacing between the inner and outer walls, thereby changing the capacitance between the inner and outer wall. Another embodiment of an intravascular device includes one or more coaxial chokes for limiting heating caused by currents induced by RF signals. A conductive shield of the choke is formed of a conductive polymer to further reduce heating effects.

Abstract: The invention provides a nested tubing cannula which comprises outer and inner elongate tubular members, both having a proximal end, a distal end, and a lumen therebetween. The inner tubular member is sealed at its distal end and is nested substantially coaxially within the lumen of the outer tubular member, so that the gap between the inner and the outer tubular member defines a second lumen whereas the first lumen is the lumen of the inner tubular member. A tubular sleeve is disposed coaxially between the inner and outer tubular members. A balloon is mounted on a distal region of the outer tubular member and is in communication with the first lumen. The cannula further comprises a port proximal or distal the balloon occluder and is in communication with the second lumen. Methods for making the devices herein are disclosed.

Abstract: An aid in the percutaneous navigation through chronic total occlusions by imaging of the vasa vasorum is provided. A cavity is established in a vessel proximal to the occlusion of interest. Once the cavity is established, fluid is introduced into the cavity. The fluid is introduced under a pressure that is sufficient enough to drive the fluid into the vasa vasorum that is accessible from the cavity. An image is taken with an imaging means of the fluid filled cavity and vasa vasorum. This image is used as a visual aid for a physician to visualize the path/curvature of the vessel. With this visualization, the physician would be able to navigate a medical instrument through an occlusion. In addition, this visualization would aid the physician to open the occlusion and therewith promote blood flow in vessel, for instance, by expanding open, stenting open, or cutting away part of the occlusion.

Abstract: A collapsible ultrasonic reflector incorporates a gas-filled reflector balloon, a liquid-filled structural balloon an ultrasonic transducer disposed within the structural balloon. Acoustic energy emitted by the transducer is reflected by a highly reflective interface between the balloons. In a cardiac ablation procedure, the ultrasonic energy is focused into an annular focal region to ablate cardiac tissue extending in an annular path along the wall. Devices for stabilizing the balloon structure and for facilitating collapse and withdrawal of the balloon structure are also disclosed.

Abstract: The invention provides a nested tubing cannula which comprises outer and inner elongate tubular members, both having a proximal end, a distal end, and a lumen therebetween. The inner tubular member is sealed at its distal end and is nested substantially coaxially within the lumen of the outer tubular member, so that the gap between the inner and the outer tubular member defines a second lumen whereas the first lumen is the lumen of the inner tubular member. A tubular sleeve is disposed coaxially between the inner and outer tubular members. A balloon is mounted on a distal region of the outer tubular member and is in communication with the first lumen. The cannula further comprises a port proximal or distal the balloon occluder and is in communication with the second lumen. Methods for making the devices herein are disclosed.

Abstract: A thrombolysis catheter system having a fixed length infusion zone is disclosed. The invention contemplates apparatus, method and kit aspects. The apparatus, which has the capability to track a guidewire, uses a multilumen catheter to deliver radially thrombolytic agent to an infusion zone defined by one or more balloon means. In one aspect, with an occluder means, a primary lumen of the catheter is used both for catheter placement and delivery of fluid. The method discloses utilization of radiopaque indicia to place the catheter in proximity to the occlusion or diseased tissue to be treated. The kit includes a catheter of the invention in conjunction with a steerable guidewire and a tip occluder wire, either or both of the tip occluder wire and the guidewire having an enlargement on their distal tip which cooperates with a reduced diameter portion of the catheter lumen.

Abstract: The present invention is directed to a polymeric balloon for an intracorporeal catheter having a plurality of spaced apart, remotely imageable layers which facilitate the folding of the balloon. The imageable layer may facilitate imaging the balloon or a portion thereof preferably by fluoroscopic or magnetic resonance based remote imaging systems.

Abstract: A temporary balloon-type electrode for insertion and temporary fixation in a blood vessel of a heart, for determining a suitable place therein for a subsequently inserted and fixed permanent electrode, has a catheter and an inflatable and deflatable balloon member disposed at a distal end portion of the catheter. The balloon member has at least one radially expandable hollow body. At least one electrode surface contact member is disposed at a peripheral portion of the hollow body, and flow passages are provided for allowing a blood flow to pass the balloon member when inflated. The temporary balloon-type electrode is particularly suited for use in coronary sinus and peripheral coronary veins of the heart.

Abstract: Methods and apparatus for creating and delivering a medical agent into an isolated vein segment, the isolated vein segment not having any communicating vein branches, the apparatus comprising a catheter having at least expandable vein occlusion devices to engage and expand the inside wall of a vein, thereby blocking the interior of the vein and preventing fluid located in the isolated segment from flowing between the occlusion devices and the wall of the vein at a pressure within the isolated vein segment of at least 100, and preferably 200, millimeters of mercury, the catheter including one or more lumens for directing a fluid into the isolated vein segment at a pressure of at least 100 millimeters of mercury.

Abstract: A radially expandable device having a body constructed of a generally inelastic, expanded fluoropolymer material is described. The body is deployable upon application of a radial expansion force from a reduced diameter, collapsed configuration to an expanded configuration having a pre-defined and fixed increased diameter. The body has a singular, unitary construction of generally homogenous material that is characterized by a seamless construction of expanded fluoropolymer material, such as expanded polytetrafluoroethylene (ePTFE), and is preferably constructed through an extrusion and expansion process. The body is further characterized by a microstructure of nodes interconnected by fibrils in which substantially all the nodes of the body are oriented generally perpendicularly to the longitudinal axis of the body.

Abstract: A catheter for insertion into an artery having deposits of plaque and/or thrombus includes, at its distal end an ultrasonic transducer and a dilatation balloon surrounding the transducer such that when the balloon is positioned in the artery adjacent the deposits and inflated, energizing of the ultrasonic transducer will focus the ultrasonic energy against the deposits to cause dissolution of the thrombus into microscopic particles and cause cracking and softening of the plaque. Other embodiments include the provision of a second ultrasonic transducer as a means for viewing the treatment site, and a second balloon to cooperate with the first balloon to define a chamber between the balloons and with a lumen and a port connected to the chamber to remove any debris of larger than microscopic size which might otherwise tend to move downstream and cause further obstructions. Also described is the use of an expandable filtering device distal of the dilatation balloon for trapping such particles.

Abstract: A local and site-specific drug delivery apparatus for delivering a drug to a specific site is characterized by the combination of a carrier material which reflects or absorbs or emits electromagnetic or mechanical (e.g. ultrasonic) vibrations enabling the monitoring of the material, a drug associated with the carrier material, and a local-delivery mechanism for delivering the carrier material and the drug to a specific site. The local-delivery mechanism may comprise a local-delivery catheter, such as a balloon-type catheter, and the drug delivery apparatus may additionally include a monitor for monitoring the delivery of the drug to the specific site, such as an ultrasonic imaging system. The drug delivery apparatus may also include a vibration generator for inducing release of the drug from the carrier material when the carrier material is at the specific site, such as a generator of ultrasonic energy.

Abstract: An intravascular device such as an introducer sheath or a balloon catheter, and methods for use thereof, comprising an elongate member having a proximal end and a distal end and a first lumen and a second lumen. The first lumen communicates with a first proximal opening at the proximal end of the elongate member and with a distal opening at the distal end of the elongate member. The second lumen terminates distally and communicates with the first lumen at a location proximal of the first distal opening and has a proximal opening located proximally therefrom. One or more perfusion openings may be located in the device to allow blood flow therethrough. The proximal opening of the second lumen may be located distally of the proximal opening of the first lumen. A balloon may be located on a distal portion of the elongate shaft.

Abstract: An ultrasound system is disclosed having a catheter including an elongate flexible catheter body having at least one lumen extending longitudinally therethrough. The catheter further includes an ultrasound transmission member extending longitudinally through the lumen of the catheter body, the ultrasound transmission member having a proximal end connectable to an ultrasound transducer. The catheter also includes a distal head positioned on the distal end of the ultrasound transmission member. The catheter also has a coil with a proximal end connected to the distal end of the catheter body, and a distal end connected to the distal head. The coil defines a lumen communicating with the lumen of the catheter body. The ultrasound system also includes a sonic connector for coupling the ultrasound transmission member to the transducer. Different configurations are disclosed for the distal head and the ultrasound transmission member.

Abstract: The cuff on the patient end of a tracheal tube is attached at one end to the inside of the tube and at the opposite end to the outside of the tube. The cuff encloses an axial sleeve that is slidably mounted within the patient end of the tube and is urged forwardly by a resilient collar. The sleeve can be retracted by applying vacuum to the cuff and, when released, extends forwards to prevent the cuff occluding the patient end of the tube.

Abstract: An expandable ablation electrode is provided on a catheter constructed to access the heart. When the electrode is introduced to the heart, it is small and suitably flexible to maneuver through the torturous path. However, when the catheter is in place in the heart, the electrode is expansible in diameter to a substantially larger dimension, and is relatively rigid, enabling a large conductive surface to press against the heart tissue with the desired contact pressure. When RF energy is then applied to the electrode it produces a burn lesion of desired large size and depth. This overcomes the limitations to size that have been encountered using conventional rigid electrodes.