Abstract: Extremely hydrophobic nitric oxide (NO) releasing polymers are disclosed. The extremely hydrophobic NO-releasing polymers provided are extensively cross-linked polyamine-derivatized divinylbenzene diazeniumdiolates. These polymers can be loaded with extremely high NO levels and designed to release NO in manners than mimic natural biological systems. The NO-releasing extremely hydrophobic polymers provided can maintain a sustained NO release for periods exceeding nine months. Also provided are related medical devices made using these NO-releasing extremely hydrophobic polymers.

Abstract: A catheter shaft for a balloon catheter includes a centrally-located guidewire lumen. A body portion of the catheter shaft includes arc-shaped nodes that define a guidewire track within the guidewire lumen. Each node provides a single contact point for a guidewire within the guidewire lumen, thereby limiting frictional contact due to “rolling” friction, rather than “sliding” friction, between the catheter shaft and an inserted guidewire. The nodes include a crown region that includes the contact point. The crown region may be formed of a material having a lower coefficient of friction than the remaining portion of the catheter shaft. At least one node has an inflation lumen extending therethrough. The inflation lumen is in fluid communication with an interior of an inflatable balloon.

Abstract: The invention is an intraluminal therapy catheter having a least two treatment members disposed near the distal end of the catheter, the members being independently inflatable to perform angioplasty and/or fluid-sourced brachytherapy. A first treatment member is helically mounted about the shaft of the catheter, and forms a helical perfusion channel when inflated into contact with the vessel being treated. In a first embodiment of the invention, the second treatment member is also helically mounted about the catheter shaft and capable of forming a helical perfusion channel when inflated into contact with the vessel. The first and second treatment members are intertwined to form a double helix configuration wherein each member is capable of being inflated to generally fill the helical perfusion channel created by simultaneous inflation of the other member.

Abstract: A bifurcated endoluminal prosthesis is provided that includes a valve or gate in one of the bifurcated branches. The valve or gate prevents flow of blood through the branch when it is closed and permits the flow of blood when it is open. In one variation, the valve comprises a spring member attached to a graft material substantially impermeable to the flow of blood. The spring member holds the graft material over the opening that forms a lumen in the bifurcated portion. The spring member may be flipped from a closed position in which it is initially deployed, to an open position whereby the graft material forms an opening continuous with lumen in the bifurcated portion permitting the flow of blood therethrough. The invention may be used in bifurcated or branched tubular grafts for endoluminal placement within a body lumen, including blood vessels, and for the treatment of abdominal and other aneurysms.

Abstract: A device for sensing aneurysmal pressure in a body cavity includes a housing including at least one chamber formed therein. A first fluid is positioned in a first portion of the chamber. A second fluid is positioned in a second portion of the chamber. A compressible fluid is positioned in the second portion of the chamber. A divider is positioned between the first and second fluids. A pressure membrane is in communication with the first portion of the chamber. The aneurysmal pressure is transmitted through the membrane and the first fluid to position the divider within the chamber. A method for determining aneurysmal pressure in a body cavity includes deploying a sensing device including radiopaque substance adjacent an aneurysm. The radiopaque substance is moved within the device in response to the aneurysmal pressure. The sensing device is imaged and pressure and/or relative pressure is read directly.

Abstract: Disclosed herein is an improved core wire for use in a medical catheter. In one aspect, a tapering core wire is incorporated into the distal end of a catheter. The catheter has a tubular body. Both ends of an inflatable balloon are mounted to the tubular body. The core wire extends from the distal end of the tubular body. In one embodiment, substantially all of the taper of the core wire occurs in the extending portion of the core wire over a length of at least 15 mm but no more than 60 mm. In another aspect, a core wire with a shapeable tip and method of manufacturing the same are provided. A core wire previously made superelastic is subject to additional processing to remove its superelasticity thereby allowing the material to be shapeable to aid in advancing the core wire through a blood vessel or other body cavities. In another aspect of the present invention, a method is provided for securing the core wire to the distal end of an elongated catheter tubular body.

Abstract: An endovascular support device for treatment of chronic restenosis or other vascular narrowing is disclosed together with a method of manufacture and a method for delivering a plurality of such devices to an affected area of a vessel. In a preferred embodiment, the endovascular support device comprises a unitary wire-like structure configured to form a plurality of upper and lower peaks which may be compressed for delivery to an affected area of a coronary or peripheral vessel in a human, and then expanded to maintain a passageway through the vessel.

Abstract: A tubular prosthesis is implanted at a target location within a body lumen by transluminally placing and embedding an expansible prosthesis body within a sealing layer. The sealing layer occludes at least a circumferential band within an interface region between the prosthesis body and the inner wall of the body lumen, thus providing for blockage of body lumen flow past the prosthesis. The sealing layer may be introduced prior to or simultaneously with the prosthesis body. A tubular prosthesis may be implanted in blood vessels, particularly to protect aneurysms.

Abstract: A method for reducing distal embolization during insertion of devices to treat plaque, thrombi and other intravascular occlusions. Using a guide catheter, a guidewire is delivered to a site proximal to the lesion. An aspiration catheter is then introduced over the guidewire, and the two are moved together in a distal to proximal direction across the occlusion. The aspiration catheter is then moved in a proximal to distal direction while continuously aspirating, which prevents embolization of any particles which may be created during the crossing of the guidewire.

Abstract: An expandable stent and stent graft having a small initial diameter, flexibility along its longitudinal axis prior to expansion and a large expanded and rigid Local stain on the stent material is minimized, as and after the balloon is expanded. More particularly, the stent has rotation joints having minimal strain during stent expansion. The stent is substantially the same length before and after expansion and being flexible longitudinally when constrained, it is easy to locate. A method of manufacturing stents is described comprising rotation of a tube beneath a moving film, with light passing through the film onto the tube, at selected locations. A laser scanning system for stent manufacture is also disclosed.

Abstract: A prosthesis for implantation in a blood vessel includes struts with a cross-section having a flat base with angled edges on the inner surface and chamfered edges on the outer or exterior surface. The base angled edge is substantially a right angle, while the outer or exterior surface has edges that are chamfered with either round or angled chamfers. The chamfers could be manufactured by either machining the chamfer into the stock material, or by tumbling the stent in a tumbler to abrasively wear the edges to form a chamfer.

Abstract: Balloons and balloon catheters with a superior overall combination of distensibility, elastic stress response and strength. The improved properties of the balloons result from the method or process used to form the balloons, as well as the polymeric materials used in said balloon forming process. Additionally, the enhanced combination of properties of the balloons will not be adversely affected by the novel sterilization process contemplated by this invention.

Abstract: A temporarily implantable brachyherapy assembly is adapted to locally deliver acute doses of radiation to tissue at or adjacent to a body lumen wall. The assembly includes a radiation source which is stored in a housing in radioactive isolation. A first delivery member is adapted to removably engage the radiation source and remove it from storage for delivery to an injured or stenosed region of a vessel. The first delivery member is adapted to be delivered to the site through a lumen extending through a second delivery member. The second delivery member is also a shielding device with a shielded region of substantially radiopaque material, and also with an unshielded region made of substantially radioluscent material and which is distal to the shielded region. A third delivery member or centering device has a lumen through which the second delivery member may be delivered to the treatment site.

Abstract: A method for the treatment of a stenosis or an occlusion in a blood vessel is disclosed in which a main catheter is first delivered to a site proximal to the occlusion. The main catheter may include an occlusive device at its distal end. An inner catheter or elongate member (e.g., a guidewire) having an occlusive device at its distal end is delivered to the site of the occlusion, and the occlusive device is activated at a site distal to the occlusion. A therapy catheter is then introduced to treat the occlusion. Next, a catheter is delivered just proximal to the occlusive device, and this catheter is used to aspirate and/or irrigate the area removing particles and debris. The aspiration and irrigation steps are preferably repeated until the particles and debris are removed. Perfusion may be performed by using a perfusion-filter distal of the lesion to be treated or a hypotube which extends beyond the occlusive device attached to the guidewire.

Abstract: The invention is a dilation catheter which comprises an elongated catheter shaft, a guide wire tube, and an angioplasty balloon. The distal end of the balloon is attached to the distal portion of the guide wire tube, and the proximal portion of the balloon is attached to the distal portion of the catheter shaft. A stiffening wire is attached to the inner wall of the catheter shaft at a plurality of points along its length. The distal extremity of the guide wire tube is decreased in size relative to the proximal portion of the guide wire tube. A fluid is contained within the guide wire lumen.

Abstract: The present invention is a collapsible blood filter for use during a vascular procedure, such as angioplasty or stent deployment. A filter made of braided filaments is located on the distal end of a delivery member, and the filter is deployed downstream of the vascular treatment site to capture emboli released during and immediately after the procedure. Optimal braid geometry of the filter ensures that captured emboli will be retained during collapse and removal of the filter following the procedure.

Abstract: The present invention provides controlled expansion endoluminal prostheses and methods for their deployment and expansion. The present stent-grafts generally comprise a radially expansible tubular frame and a plastically expansible liner on the frame. Either the frame or the liner includes a reinforcing element which limits expansion of the stent-graft at a predetermined expanded size. In some embodiments, the reinforcing element restrains the frame, for example, by limiting the circumferential diagonals of perforations on a perforate frame structure. Generally, however, the reinforcing element is included in the liner as circumferentially oriented yarn. A particularly advantageous liner includes composite circumferential yarns having inexpansible fibers wrapped around an expansible fiber, such as a partially oriented yarn, PTFE, or the like.

Abstract: A stent delivery catheter includes an extendable shaft portion, a tubular balloon mounted thereon, a stent and a pair of elastic retaining caps. The balloon is mounted onto the catheter at a mounted length that is shorter than the formed length of the balloon to generate excess balloon material which is gathered into circumferential folds. The extendable portion of the catheter shaft elongates in response to tension applied by the balloon as the folds open during inflation. Elongation of the catheter shaft drives the retaining caps apart to uncover the ends of the stent.

Abstract: A delivery, deployment and retrieval device for a stent made from a phase-change material includes a balloon catheter modified to allow the stent to be secured on the outside of the balloon without the need for a sheath. A temperature-controlled fluid to effect a phase change to expand the stent is injected through an inflation lumen to maintain the selected temperature and to inflate the balloon. The balloon maintains intimate physical and thermal contact with the stent during deployment. One or more exit apertures are provided for the fluid to escape from the inflation lumen and enhance the phase change by bathing the stent with the fluid.

Abstract: The present invention provides modular bifurcated intraluminal tubular prostheses, particularly stents and stent-grafts, for the treatment of disease conditions, particularly aneurysms. Modular sections of the prostheses, or “prosthetic modules,” may be selectively assembled to form a prosthesis having characteristics which are tailored to the specific requirements of the patient, including branch angle and branch lumen sizes which match the patients vascular geometry. A Y-connector prosthetic module structure provides support and separation for each of the adjacent branching lumens. Radiopaque markers on the prostheses promote alignment between prosthetic modules and with the body lumen system.