Abstract: A robotic medical system and method of performing a medical procedure are provided. The robotic medical system comprises a user interface configured for receiving commands, an electromechanical driver configured for being coupled to outer and inner catheters having proximal and distal balloons, a balloon controller configured for being coupled to the proximal and distal balloons, and an electric controller configured for directing the electromechanical driver to linearly translate the outer and inner catheters relative to each other and for directing the balloon controller to inflate and deflate the proximal and distal balloons in response to the command(s). The method may comprise inflating and deflating the proximal and distal balloons, and linearly translating the inner and outer catheters relative to each other in a specified sequence to move the inner and outer catheters along the anatomical vessel.

Abstract: Devices for enhancing minimally invasive cardiac surgery include a visualization device including an inflatable balloon at or near the distal end. Some visualization devices also include one or more lumens for allowing the introduction of one or more devices to a surgical site through the visualization device. Systems of the invention involve a visualization device which has at least one lumen for allowing introduction of an ablation device and/or other devices. A visualization device with an inflatable balloon may be positioned to create a space between a heart and pericardium when the balloon is inflated.

Abstract: A catheter assembly may comprise a guide catheter, a balloon catheter with a steering balloon and a stabilizing balloon and a guide wire. The stabilizing balloon secures the balloon catheter to the guide catheter while the steering balloon secures the catheter assembly to the vessel wall. In another embodiment, the balloon catheter has three balloons engaged to the exterior surface, a steering balloon, a stabilizing balloon and an anchoring balloon.

Abstract: A catheter system comprising a guidewire, an endovascular catheter, and an aspiration catheter. The guidewire has an expandable occluder mounted on a distal end. The guidewire and the endovascular catheter are insertable into a lumen of the aspiration catheter. The aspiration catheter also includes infusion and aspiration lumen(s) and port(s). Methods of using the catheter system for treating a vascular lesion and removing embolic material during the procedure are also disclosed.

Abstract: A first balloon is fitted to an insertion portion of an endoscope and a second balloon is fitted to an insertion aid member. An end connector of a tube is connected to a balloon control device that supplies and sucks air into and from the first balloon and the second balloon. A duct that communicates with the first balloon, a duct that communicates with the second balloon, and a duct that communicates with a clearance between the insertion portion and the insertion aid member are formed in the end connector.

Abstract: Composite fiber reinforced balloons for medical devices prepared by applying a web of fibers to the exterior of a preformed underlying balloon and encasing the web with a matrix material to form a composite balloon. The fiber web is applied to at least the cone portion of the underlying balloon form. Either the cone portion of the underlying balloon form, or the web fibers applied to said cone portion, or both, have a friction-enhancing material coated thereon.

Abstract: Systems for treating a vessel bifurcation comprise a bifurcated catheter having a first branch and a second branch. Each branch defining an exchange region that extends from the distal end of the shaft to the guidewire port of the shaft. The catheter has a radial alignment mechanism which provides improved radial alignment characteristics of at least the exchange region of the branches.

Abstract: Apparatus and methods for ablating tissue surrounding a tubular anatomical structure such as the wall of a blood vessel or prostatic tissue surrounding the urethra. The apparatus includes an ultrasonic emitter such as a cylindrical emitter and an inflatable annular lens balloon surrounding the ultrasonic emitter. The lens balloon is inflated with a liquid having acoustic velocity different than that of the surrounding medium, so as to form an annular refracting surface. The acoustic energy from the emitter is focused into an annular focal region.

Abstract: A catheter, in particular for endovascular applications, including a long and flexible, hollow, tubular body having an insertion end and a connection end intended to remain outside the body. The catheter includes in the insertion end at least two elements which are expandable/contractible by means of external operations. Those elements are located at a distance from each other, one upstream and the other downstream of a given section of a vessel. With the catheter it is possible to operate in the section between the two expandable elements and, if necessary, in the intermediate arterial branch which, on account of the two elements upstream and downstream, will have a zero flow.

Abstract: A method for maintaining clear passageways in an extracorporeal blood flow system. The method comprises intermittently providing one or more anti-clotting agents to a passageway of the extracorporeal blood flow system. Also disclosed is an extracorporeal blood flow system. The system comprises a passageway, and a device operatively connected to provide one or more anti-clotting agents to a least a portion of said passageway.

Abstract: Embodiments of the present invention are directed to a method and apparatus for accurate positioning of a dual balloon catheter. In one embodiment of the present invention, a first balloon provides an anchoring point. In one embodiment, the first balloon has protrusions to help secure its position. In one embodiment, once the first balloon is inflated, it provides a fixed position relative to which a second balloon is accurately positioned in the treatment region. In another embodiment, a second balloon imparts a radial force. In another embodiment, a second balloon imparts an axial force, using the first balloon as an anchor against which the force is applied. The force may be applied in a forward or a backward direction. In yet another embodiment, a second balloon imparts a rotational force, using the first balloon as an anchor against which the force is applied.

Abstract: Apparatus and methods for treatment of stroke are provided. In a preferred embodiment, the present invention disposes at least one catheter having a distal occlusive member in either the common carotid artery (CCA) or both the vertebral artery (VA) and the CCA on the hemisphere of the cerebral occlusion. Blood flow in the opposing carotid and/or vertebral arteries may be inhibited. Retrograde or antegrade flow may be provided through either catheter independently to effectively control cerebral flow characteristics. Under such controlled flow conditions, a thrombectomy device may be used to treat the occlusion, and any emboli generated are directed into the catheter(s).

Abstract: Clot disruption and dissolution are achieved using a catheter having the ability to infuse a thrombolytic agent, agitate the clot and agent, and aspirate broken-up clot from the blood vessel. A flow resistor in the catheter provides for infusion and/or aspiration to be concentrated primarily at a clot treatment area in a blood vessel while also providing optional infusion and/or aspiration distal to the treatment area. In some embodiments, infusion, aspiration and guidewire passage occur through a common lumen. The thrombolytic agent, such as tPA, streptokinase, or urokinase, is directly released into the clot at the point where the agitator is engaging the clot. In this way, the thrombolytic activity of the agent is enhanced and the dissolution of the clot is improved.

Abstract: Patients having diminished circulation in the cerebral vasculature as a result of cardiac arrest or from other causes are treated by flowing an oxygenated medium through an arterial access site into the cerebral vasculature and collecting the medium through an access site in the venous site of the cerebral vasculature. In addition to oxygenation, the recirculating blood may also be cooled to hypothermically treat and preserve brain tissue. Isolation and cooling of cerebral vasculature in patients undergoing aortic and other procedures is achieved by internally occluding at least the right common carotid artery above the aortic arch. Blood or other oxygenated medium is perfused through the occluded common carotid artery(ies) and into the arterial cerebral vasculature. Usually, oxygen depleted blood or other medium leaving the cerebral vasculature is collected, oxygenated, and cooled in an extracorporeal circuit so that it may be returned to the patient.

Abstract: Devices and methods for their use in increasing the aortic valve flow of a stenotic aortic valve are provided. The subject devices include an aortic valve isolation element and an aortic valve flushing element. The aortic valve isolation element is made up of a ventricular side aortic valve occlusion element, coronary ostia occlusion elements and an ascending aorta occlusion element. The aortic valve flushing element is made up of a dissolution fluid introducing element and a fluid removal element. In practicing the subject methods, a stenotic aortic valve is first isolated. Next, the isolated valve is flushed with a dissolution fluid, e.g., an acidic dissolution fluid, for a period of time sufficient for the aortic valve flow of the treated valve to be increased. In certain embodiments, the valve is also contacted with a dissolution fluid attenuating fluid, e.g., a buffer, during the flushing step in order to limit the contact of non-valve tissue with the dissolution fluid.

Abstract: A cardioplegia occluder and methods of using the device during cardiac surgery are disclosed. The system typically includes a substantially rigid cannula with an occluder mounted on the distal region of the cannula that expands upon activation to occlude the aorta downstream of an infusion port which delivers cardioplegia solution to arrest the heart. Systems including cutting blades, blade guards, flanges, radiopaque markers and occluder aligners are also disclosed. In use, the distal end of the cannula is inserted through an incision into the aorta, the occluder is expanded and cardioplegia solution is infused upstream of the aorta to arrest the heart. The infusion port can alternately be used to aspirate cardioplegia or embolic debris or other unwanted material from the aorta.

Abstract: A catheter, in particular for endovascular applications, including a long and flexible, hollow, tubular body having an insertion end and a connection end intended to remain outside the body. The catheter includes in the insertion end at least two elements which are expandable/contractible by means of external operations. Those elements are located at a distance from each other, one upstream and the other downstream of a given section of a vessel. With the catheter it is possible to operate in the section between the two expandable elements and, if necessary, in the intermediate arterial branch which, on account of the two elements upstream and downstream, will have a zero flow.

Abstract: A vascular catheter assembly includes an over-the-wire stent deployment catheter and a flow-by-channel assembly. The stent deployment catheter is positioned just below the occluded artery in accordance with standard procedures. The flow-by-channel then shunts blood, and thus all friable plaque, from the high pressure carotid occlusion to the negative pressure extremity to effectively reverse the flow of blood through the occluded artery. The stent is then advanced into the narrowed artery and deployed. Thus, the vascular catheter assembly takes advantage of the collateral blood flow to solve the problem of stroke during endovascular procedures.

Abstract: Clot disruption and dissolution are achieved using a catheter having both an agitator and the ability to deliver a thrombolytic agent. The catheter is introduced to a target region with a blood vessel and the agitator manipulated to engage and disrupt a region of clot therein. The thrombolytic agent, such as tPA, streptokinase, or urokinase, is directly released into the clot at the point where the agitator is engaging the clot. In this way, the thrombolytic activity of the agent is enhanced and the dissolution of the clot is improved.

Abstract: Catheter systems and methods for their use in enhancing fluid flow through a vascular site occupied by a vascular occlusion are provided. The subject catheter systems include at least an aspiration catheter and at least one of a total occlusion insert catheter and a partial occlusion insert catheter, where the insert catheters are capable of being slidably moved in the lumen of the aspiration catheter. In practicing the subject methods, a surface of the vascular occlusion is flushed with an acidic dissolution fluid using the subject catheter systems for a period of time sufficient for fluid flow through the vascular site to be enhanced, e.g. increased or established. The subject catheter systems and methods find use in the treatment of a variety of different vascular diseases characterized by the presence of calcified vascular occlusions, including peripheral and coronary vascular diseases.

Abstract: A therapeutic interventional device such as a balloon catheter is provided with a nozzle to induce a retrograde flow in the vessel by injecting fluid through the nozzle into the vessel. The retrograde flow can be used to clear debris from a distal protection device such as a filter or balloon and may additionally be used to clear the vessel of clot prior to the intervention.

Abstract: The present invention is directed to apparatus and methods for treating a vascular occlusion by providing an infusion catheter having an atraumatic tip and at least one delivery port configured to infuse fluid into the occlusion. The fluid that is infused dilutes the occlusion and reduces adhesion of the occlusion to an intima of the vessel wall, thereby causing the occlusion to dislodge. Emboli generated in the process are directed into an emboli removal catheter for removal.

Abstract: An intra pelvic cancer therapeutic agent perfusion apparatus and method for administering a cancer therapeutic agent to and recovering same from a cancer tissue site within the pelvis. The tip of a first sheath is percutaneously inserted into the femoral artery and the tip of a second sheath is inserted into the femoral vein. A first balloon catheter is inserted into the aorta through the femoral artery and a second balloon catheter is inserted into the vena cava through the femoral vein. The first balloon catheter is used to block the blood flow and the second balloon is inflated to form an intravenous closed region between the site of insertion in the vena cava and a lower limb side venous site. A body fluid containing a cancer therapeutic agent is administered to the intra arterial closed region through the first sheath and is removed therefrom through the second sheath.

Abstract: Vascular access systems, devices and methods for facilitating repeated access to a blood vessel. These systems, devices and methods can be used in external blood treatment, such as dialysis, and in intra-venous administration of medicines, such as heparin, for extended periods of time, while avoiding deleterious effects such as those derived from repeated puncturing of the blood vessel tissues or exposure of such tissues to abnormal fluid flows. The vascular access systems comprise an anastomosis graft vessel, an occlusal device, such as an occlusal balloon, and a port device for accessing the occlusal device. Occlusal devices can be self-contained, they can rely on osmosis, and they can serve as the support of an agent to which the blood stream is exposed, either by transport or by mere contact. In addition, occlusal devices can adopt a distended and a collapsed configuration, the latter allowing for blood flow through the anastomosis graft vessel.

Abstract: A balloon arterial cannula and methods for filtering blood. The devices generally include a mesh for filtering blood flowing within a blood vessel, particularly within an artery such as the aorta, a structure adapted to open and close the mesh within the blood vessel, a means to actuate the structure, and a balloon occluder which typically includes a flexible material enclosing a chamber. The methods generally include the steps of introducing a mesh into a blood vessel to capture embolic material, adjusting the mesh, if necessary, during the course of filtration, inflating the balloon occluder to occlude the vessel upstream of the mesh, and thereafter deflating the balloon occluder and removing the mesh and the captured foreign matter from the blood vessel. Additionally, visualization techniques are used to ensure effective filtration.

Abstract: Methods and apparatus are provided for removing emboli during an angioplasty, stenting, or surgical procedure comprising apparatus for occluding the external carotid artery to prevent reversal of flow into the internal carotid artery during carotid stenting, the apparatus further comprising a wedge or capsule configured to reduce the risk of potentially dangerous interaction with the stent during retrieval.

Abstract: A multi-catheter emboli containment system is disclosed which is adapted to provide at least one pair of optimized paths for irrigation and aspiration fluid flow. Through careful design of the cross-sectional area of these paths, the present system is able to be compactly utilized in even the smaller size blood vessels. The catheter system itself is provided with occlusive devices to form an emboli containment chamber in which irrigation and aspiration occur. The catheter system of the present invention provides an improved emboli containment and removal system which can be utilized in a wide range of vessel diameters. The system is easy to use and can quickly and efficiently evacuate the containment chamber.

Abstract: Apparatus and methods for treatment of stroke are provided. In a preferred embodiment, the present invention disposes at least one catheter having a distal occlusive member in either the common carotid artery (CCA) or both the vertebral artery (VA) and the CCA on the hemisphere of the cerebral occlusion. Blood flow in the opposing carotid and/or vertebral arteries may be inhibited. Retrograde or antegrade flow may be provided through either catheter independently to effectively control cerebral flow characteristics. Under such controlled flow conditions, a thrombectomy device may be used to treat the occlusion, and any emboli generated are directed into the catheter(s).

Abstract: Multi-lumen balloons for use as or in conjunction with balloon dilation catheters, and methods for making such balloons, are disclosed.

Abstract: A passive perfusion sleeve/placement catheter assembly for performing coronary angioplasty allows prolonged dilatations without blocking blood flow. The perfusion sleeve comprise an elongated shaft with a distally mounted composite balloon including a semi-rigid inner material surrounded by a more flexible and expandable outer material which can extend radially from the catheter and engage the vessel wall and atheroma. The semi-rigid inner material requires more pressure to cause distention than the outer expandable material thereby defining a blood flow channel. The perfusion sleeve/placement catheter assembly of the present invention includes a perfusion sleeve apparatus having a multiple lumen shaft and an expanding balloon connected to a distal end of the shaft. A placement catheter is employed to assist in delivery and retraction of the sleeve.

Abstract: An atrial isolator comprising two tubular members, two lumens, drainage ports, and expandable occluders. The expandable occluders are adapted to engage an opening of the superior vena cava into the right atrium or the inferior vena cava and right tricuspid valve into the right atrium. The second tubular member is inserted into the lumen of the first tubular member to provide a displacement between the first expandable occluder and the second expandable occluder which is adjustable. A cardioplegia port is located between the two expandable occluders and in communication with a cardioplegic lumen. Methods of using such an atrial isolator are also disclosed, particularly to provide circulatory isolation of the heart and coronary blood vessels, and cardioplegia delivery.

Abstract: An apparatus and method for treating Barrett's tissue by removal of the mucosa through PhotoDynamic Therapy(PDT) is provided. A viscous gel is the medium used to carry the photosensitizer to the treatment site and allow sufficient time to transfer to the tissue. The gel's viscosity will allow it to adhere to the tissue for a sufficient amount of time to transfer the photosensitizer or sufficient time for a mechanical device such as an expanding balloon to press the gel into the tissue. The photosensitizer within the gel is activated by the corresponding wavelength of radiation. An extended multi-balloon system limits the area of treatment and localizes the spread of the gel. An endoscope with fiber optics may be used to view the operation. A preferred embodiment of the apparatus contains a catheter with at least two balloons, one to block drainage of the photosensitizer into the stomach and one to limit the height of the treatment area and to press the gel into the tissue.

Abstract: Aspiration catheters and methods for the treatment of an occlusion in a blood vessel. These catheters and methods are especially useful in the removal of occlusions from saphenous vein grafts, the coronary and carotid arteries, arteries above the aortic arch and even smaller vessels. The catheters of the present invention are provided in either over-the-wire or in single operator form. Radiopaque markers are preferably incorporated into distal ends of the catheters, and visual markers are incorporated into the proximal end of the catheters, to facilitate their positioning within the body. The catheters are provided with varying flexibility along the length of the shaft, such that they are soft and flexible enough to be navigated through the vasculature of a patient without causing damage, but are stiff enough to sustain the axial push required to position the catheter properly and to sustain the aspiration pressures.

Abstract: A multi-catheter emboli containment system is disclosed which is adapted to provide at least one pair of optimized paths for irrigation and aspiration fluid flow. Through careful design of the cross-sectional area of these paths, the present system is able to be compactly utilized in even the smaller size blood vessels. The catheter system itself is provided with occlusive devices to form an emboli containment chamber in which irrigation and aspiration occur. The catheter system of the present invention provides an improved emboli containment and removal system which can be utilized in a wide range of vessel diameters. The system is easy to use and can quickly and efficiently evacuate the containment chamber.

Abstract: A preferred apparatus for delivering an intravascular drug such as a sclerosing agent (or a microfoam sclerosing agent) to a varicose vein includes a catheter having three concentric tubes. The innermost tube has a guide wire lumen and an inflation lumen. The distal end of the innermost tube has an integral inflatable occlusion balloon in fluid communication with the inflation lumen. The intermediate tube has a lumen through which the innermost tube extends. The distal end of the intermediate tube has a self-expanding balloon with a plurality of fluid pores in fluid communication with the intermediate tube lumen. The outer tube has a lumen through which the intermediate tube extends. Sclerosing agent is dispensed through the intermediate tube to pores located at the distal end of the intermediate tube or in the self-expanding balloon. Veins are sclerosed as the self-expanding balloon is pulled through and ultimately out of the vein.

Abstract: A method of performing an operation including angioplasty of the internal carotid artery includes blocking blood flow in the internal carotid artery, performing the angioplasty while the blood flow is blocked in the internal carotid artery, and reversing flow in the internal carotid artery after the angioplasty has been performed to wash material loosened during the angioplasty out of the internal carotid artery. Normal flow in the internal carotid artery is restored after the loosened material is washed out of the internal carotid artery.

Abstract: A method and apparatus for pressurizing the right atrium or right ventricle of a beating heart during surgery to assist cardiac function. The apparatus has an intake tube for insertion in the inferior or superior vena cava, a return tube for insertion in the right atrium or right ventricle, and a pump (e.g., a peristaltic pump). In operation, blood is pumped from the vena cava into an intake port of the intake tube, from the intake tube through the pump to the return tube, and from the return tube to the right atrium or right ventricle. Optionally, a balloon mounted around the intake tube's distal end is inflated to center the intake port in the vena cava and provide a pressure bulkhead. The pump preferably pumps blood in one direction from an input port to an output port.

Abstract: Enabled or activated closure and sealing devices in the form of closure balloons, and related methods, are disclosed, which substantially preclude entry and clotting of blood at the distal end of a lumen of an indwelling catheter tube during times when flow therein is not occurring. The closure and sealing balloon is disabled or deactivated to accommodate flow, without clotting, through the lumen of the catheter tube when flow therein is resumed.

Abstract: A catheter system is provided for accessing the coronary ostia transluminally from a peripheral arterial access site, such as the femoral artery, and for inducing cardioplegic arrest by direct infusion of cardioplegic solution into the coronary arteries. In a first embodiment, the catheter system is in the form of a single perfusion catheter with multiple distal branches for engaging the coronary ostia. In a second embodiment, multiple perfusion catheters are delivered to the coronary ostia through a single arterial cannula. In a third embodiment, multiple perfusion catheters are delivered to the coronary ostia through a single guiding catheter. In a fourth embodiment, multiple catheters are delivered to the coronary ostia through a single guiding catheter which has distal exit ports that are arranged to direct the perfusion catheters into the coronary ostia.

Abstract: An improved catheter for delivery of a saline solution to a fallopian tube to be examined by ultrasonic energy and for filling the uterus with a saline solution simultaneously in a sealed position. The device uses first and second expandable balloon sealing elements, one for the fallopian tube opening, the other for the cervix opening to completely seal the fallopian tube and the uterus. The distance between the balloons is adjustable, and a catheterization tip is insertable through a lumen into the fallopian tube. Liquid is provided to the balloons through separate lumens that include cutoff valves for holding the liquid in the balloons. The method employed involves inserting the distal end of the device into the uterus opening while positioning the balloon within the cervical opening and positioning a second balloon in the fallopian tube. The method then includes expanding both balloons so that the cervix and then the fallopian tube are sealed tightly.

Abstract: A catheter for isolating a segment of blood vessel has a guiding catheter (10) with proximal and distal ends. The guiding catheter (10) has major and minor lumens (12, 14). A first balloon (16) is attached to the guiding catheter (10) at the distal end thereof. The first balloon (16) is connected via the minor lumen (14) to a first inflation port (18) such that as fluid is injected into the first inflation port (18) the first balloon (16) expands. A proximal assembly (20) connected to the major lumen (12) at the proximal end of the guiding catheter (10) has an aspiration port (24) for evacuating the major lumen (12). A guidewire (30) extending through the major lumen includes a hollow tube (32) having proximal and distal ends. A wire (34) with a shapeable core is attached to the distal end of the hollow tube (32) forming a seal therewith. A plug (52) is selectively inserted into the proximal end of the hollow tube (32) forming a seal therewith.