Abstract: Methods and apparatuses for testing the compliance of stents and stented grafts, including pre-testing them in a pre-tester tube prior to accelerated fatigue testing. The pre-tester tube is a simulated human vessel that may be made of animal tissue having approximately the same size as the human target vessel. The pre-test involves pressurizing the pre-tester tube at various normal and abnormal physiologic pulsed pressures with the stent or stented graft in place. By measuring the expansion of the pre-tester tube, the proper expansion rate of the stent or stented graft is determined. Those data are then used in a feedback loop to control the amount of expansion of a synthetic tester tube in the accelerated fatigue tests. The tester regulates the pressure in the tester tube to attain the proper expansion magnitude during the test. The animal tissue may be porcine tissue, in particular a porcine aorta to simulate the human abdominal aorta. Any side branches of the porcine aorta are tied off.

Abstract: Methods and apparatus for placing a bifurcated aortic graft, with extensions, into a body lumen. An aortic graft is provided with a unique combination of self-expanding a balloon expandable wires. The aortic graft is bifurcated and includes ipsilateral and contralateral legs. Two extension grafts are provided for frictional engagement with the legs of the aortic graft. For placement of the bifurcated aortic graft with extensions, an introducer assembly including a dilator and a sheath assembly provides access for the introduction of a main catheter and a directional catheter. The main catheter is provided for deployment of the bifurcated aortic graft within the lumen of a vessel. A balloon is provided on the main catheter for expanding the balloon-expandable wires of the aortic graft. The directional catheter, which includes a deflecting spring portion, permits placement of a guidewire through the ipsilateral leg and into the contralateral leg of the aortic graft.

Abstract: A hemostasis valve for sealing around elongate medical instruments inserted into the body. The valve has an elastomeric valve body adapted to be received with a rigid introducer housing and seal thereagainst. The valve body has a distal end and a proximal end, and a cavity opening at the proximal end to receive the medical instruments. A pair of duckbill walls extends in the distal direction and converges and meets at a slit opening. The slit opening has an H-shape that effectively seals around multiple sizes of medical instruments, from the smallest catheter to the largest bore catheters. The duckbill walls may be planar or curvilinear, and may be reinforced with one or more ribs extending outward therefrom.

Abstract: A generally tubular intraluminal vascular graft having a linear shape that may be radially expanded from a compressed state to an expanded state within a body vessel is disclosed. The graft includes a plurality of stent portions which take the form of undulating filaments extending circumferentially along the tubular body and forming a generally ring-shaped configuration. The graft may further be equipped with a plurality of specifically-configured engagement members disposed on the outer surface of the graft which are configured to frictionally engage an inner wall of a vessel so as to inhibit longitudinal movement of the tubular body without piercing the vessel wall.

Abstract: Methods and apparatus for placing a bifurcated aortic graft, with extensions, into a body lumen. An aortic graft is provided with a unique combination of self-expanding a balloon expandable wires. The aortic graft is bifurcated and includes ipsilateral and contralateral legs. Two extension grafts are provided for frictional engagement with the legs of the aortic graft. For placement of the bifurcated aortic graft with extensions, an introducer assembly including a dilator and a sheath assembly provides access for the introduction of a main catheter and a directional catheter. The main catheter is provided for deployment of the bifurcated aortic graft within the lumen of a vessel. A balloon is provided on the main catheter for expanding the balloon-expandable wires of the aortic graft. The directional catheter, which includes a deflecting spring portion, permits placement of a guidewire through the ipsilateral leg and into the contralateral leg of the aortic graft.

Abstract: Novel intraluminal devices that include a plurality of engagement members to minimize graft migration and vessel wall damage are described. Applications of the instant teachings for AAA and TAA issues wherein proximal neck attachments are critical are featured, in addition to general usages with stenotic disease. Further, an enhanced engagement member is described for preventing the migration of a prosthetic device through a body lumen.

Abstract: A woven vascular graft having a texturized outer surface to promote tissue ingrowth into the graft. The outer surface of the graft is equipped with a plurality of threads that are woven into, and extend from, the outer surface. The threads may be arranged in rows, lines or a geometric pattern. Alternatively, the threads may be towel-like. Such towel-like threads may be arranged in the form of a cuff at each end of the graft, or may cover larger portions of the exterior of the graft. The graft may be equipped with only one texture, or with a plurality of different textures.

Abstract: A system for delivering and implanting a radially expandable endoluminal prosthesis within a body lumen (e.g., blood vessel). The system comprises a) an introducer/dilator assembly, and b) a delivery catheter/loader assembly. The introducer/dilator assembly comprises an elongate tubular introducer sheath which may be provided with a valving assembly mounted on the proximal end thereof. Such valving assembly may incorporate i) a hemostatic valve, ii) a first sealing valve and iii) a second sealing valve, positioned in series, to prevent leakage of body fluid out of the proximal end of the introducer and to permit two or more elongate members (e.g., catheters, guidewires) having differing outer diameters to be inserted through the introducer without leakage of body fluid therefrom. A dilator, which has regionalized differences in stiffness, is initially deployable within the lumen of the introducer to facilitate advancement of the introducer to its desired location within the body.

Abstract: Methods and apparatus for placing a bifurcated aortic graft, with extensions, into a body lumen. An aortic graft is provided with a unique combination of self-expanding a balloon expandable wires. The aortic graft is bifurcated and includes ipsilateral and contralateral legs. Two extension grafts are provided for frictional engagement with the legs of the aortic graft. For placement of the bifurcated aortic graft with extensions, an introducer assembly including a dilator and a sheath assembly provides access for the introduction of a main catheter and a directional catheter. The main catheter is provided for deployment of the bifurcated aortic graft within the lumen of a vessel. A balloon is provided on the main catheter for expanding the balloon-expandable wires of the aortic graft. The directional catheter, which includes a deflecting spring portion, permits placement of a guidewire through the ipsilateral leg and into the contralateral leg of the aortic graft.

Abstract: Methods and apparatus for placing a bifurcated aortic graft, with extensions, into a body lumen. An aortic graft is provided with a unique combination of self-expanding a balloon expandable wires. The aortic graft is bifurcated and includes ipsilateral and contralateral legs. Two extension grafts are provided for frictional engagement with the legs of the aortic graft. For placement of the bifurcated aortic graft with extensions, an introducer assembly including a dilator and a sheath assembly provides access for the introduction of a main catheter and a directional catheter. The main catheter is provided for deployment of the bifurcated aortic graft within the lumen of a vessel. A balloon is provided on the main catheter for expanding the balloon-expandable wires of the aortic graft. The directional catheter, which includes a deflecting spring portion, permits placement of a guidewire through the ipsilateral leg and into the contralateral leg of the aortic graft.

Abstract: Methods and apparatus for placing a bifurcated aortic graft, with extensions, into a body lumen. An aortic graft is provided with a unique combination of self-expanding a balloon expandable wires. The aortic graft is bifurcated and includes ipsilateral and contralateral legs. Two extension grafts are provided for frictional engagement with the legs of the aortic graft. For placement of the bifurcated aortic graft with extensions, an introducer assembly including a dilator and a sheath assembly provides access for the introduction of a main catheter and a directional catheter. The main catheter is provided for deployment of the bifurcated aortic graft within the lumen of a vessel. A balloon is provided on the main catheter for expanding the balloon-expandable wires of the aortic graft. The directional catheter, which includes a deflecting spring portion, permits placement of a guidewire through the ipsilateral leg and into the contralateral leg of the aortic graft.

Abstract: A vascular graft for a primary vessel adapted to bridge a side branch. The graft is especially useful for providing a support tube for a primary graft in the primary vessel on one side of the side branch. The graft includes first and second tubular sections separated by a gap. A bridging member connects the first and second tubular sections across the gap and may include a relatively rigid strut to prohibit relative axial movement of the two sections. There may be one, two or more bridging members to define one, two or more apertures through which blood can flow from within the graft through to the vessel side branch. The graft may include a flexible, desirably fabric, body supported by a wireform stent that is either self- or balloon-expandable. The graft may be deployed within the abdominal aorta on both sides of the renal arteries and have two apertures for blood to flow from the aorta to the renals.

Abstract: Methods and apparatus for placing a bifurcated aortic graft, with extensions, into a body lumen. An aortic graft is provided with a unique combination of self-expanding a balloon expandable wires. The aortic graft is bifurcated and includes ipsilateral and contralateral legs. Two extension grafts are provided for frictional engagement with the legs of the aortic graft. For placement of the bifurcated aortic graft with extensions, an introducer assembly including a dilator and a sheath assembly provides access for the introduction of a main catheter and a directional catheter. The main catheter is provided for deployment of the bifurcated aortic graft within the lumen of a vessel. A balloon is provided on the main catheter for expanding the balloon-expandable wires of the aortic graft. The directional catheter, which includes a deflecting spring portion, permits placement of a guidewire through the ipsilateral leg and into the contralateral leg of the aortic graft.

Abstract: An intraluminal catheter for directing a guidewire and/or catheter in a desired direction within a bodily vessel or cavity. The intraluminal catheter has a first elongate tubular member and a support means which can comprise a second elongate tubular member that can pass over a main support guidewire. The catheter acts as a platform as the guidewire is passed through the first elongate tubular member and is deflected transversely outwardly by an angled surface through an aperture. A second intraluminal catheter has a first elongate tubular member and a support means comprising a second elongate tubular member. The first elongate tubular member has a main portion and an end portion, with the end portion being deflectable relative to the locus of the main portion so as to direct the guidewire passing through the end portion in a desired direction in the bodily vessel.

Abstract: A system for delivering and implanting a radially expandable endoluminal prosthesis within a body lumen (e.g., blood vessel). The system comprises a) an introducer/dilator assembly, and b) a delivery catheter/loader assembly. The introducer/dilator assembly comprises an elongate tubular introducer sheath which may be provided with a valving assembly mounted on the proximal end thereof. Such valving assembly may incorporate i) a hemostatic valve, ii) a first sealing valve and iii) a second sealing valve, positioned in series, to prevent leakage of body fluid out of the proximal end of the introducer and to permit two or more elongate members (e.g., catheters, guidewires) having differing outer diameters to be inserted through the introducer without leakage of body fluid therefrom. A dilator, which has regionalized differences in stiffness, is initially deployable within the lumen of the introducer to facilitate advancement of the introducer to its desired location within the body.

Abstract: A system for delivering and implanting a radially expandable endoluminal prosthesis within a body lumen (e.g., blood vessel). The system comprises a) an introducer/dilator assembly, and b) a delivery catheter/loader assembly. The introducer/dilator assembly comprises an elongate tubular introducer sheath which may be provided with a valving assembly mounted on the proximal end thereof. Such valving assembly may incorporate i) a hemostatic valve, ii) a first sealing valve and iii) a second sealing valve, positioned in series, to prevent leakage of body fluid out of the proximal end of the introducer and to permit two or more elongate members (e.g., catheters, guidewires) having differing outer diameters to be inserted through the introducer without leakage of body fluid therefrom. A dilator, which has regionalized differences in stiffness, is initially deployable within the lumen of the introducer to facilitate advancement of the introducer to its desired location within the body.

Abstract: A hemostasis valve assembly adapted for use within a catheter introducer is disclosed. The valve assembly includes first, second and third sealing members wherein the second sealing member comprises a guide wire seal. The guide wire seal includes a plurality of lip members defining two pairs of diametrically opposed slits and an aperture intersecting at least one of the slits. The aperture is adapted to sealing engage a small diameter guide wire for preventing fluid flow out of the catheter introducer through the valve assembly, while the slits allow for the passage of a large diameter elongated member or catheter. Two pairs of diametrically opposed pre-load ribs extend radially towards the aperture for pressing the lip members together in sealing engagement. A substantially spherical inner surface is provided for guiding the guide wire to the aperture.

Abstract: Methods for folding a catheter mounted balloon, and delivery catheter systems which incorporate radially expandable intraluminal devices (e.g., stents, grafts and stented grafts) which are mounted on a balloon folded in accordance with this method. The method comprises generally folding the balloon at least twice, in opposite directions, so that any rotational forces created by the unfolding of the balloon as it is inflated will counteract each other, and will thus avoid substantial rotational movement of the intraluminal device during its radial expansion.

Abstract: A system for delivering and implanting a radially expandable endoluminal prosthesis within a body lumen (e.g., blood vessel). The system comprises a) an introducer/dilator assembly, and b) a delivery catheter/loader assembly. The introducer/dilator assembly comprises an elongate tubular introducer sheath which may be provided with a valving assembly mounted on the proximal end thereof. Such valving assembly may incorporate i) a hemostatic valve, ii) a first sealing valve and iii) a second sealing valve, positioned in series, to prevent leakage of body fluid out of the proximal end of the introducer and to permit two or more elongate members (e.g., catheters, guidewires) having differing outer diameters to be inserted through the introducer without leakage of body fluid therefrom. A dilator, which has regionalized differences in stiffness, is initially deployable within the lumen of the introducer to facilitate advancement of the introducer to its desired location within the body.

Abstract: A balloon catheter includes a flexible small-diameter guide wire provided with an enlarged-diameter distal end portion, and a flexible elongated tubular shaft with at least one dual-function fluid-conducting lumen adapted to both receive the guide wire extending therethrough, and to communicate pressurized inflation fluid to a distal balloon of the catheter. A distal orifice of the catheter communicates with the balloon and is provided with selective valving means for releasably engaging sealingly with the enlarged distal end portion of the guide wire. Apparatus is disclosed for axially moving the guide wire to effect engagement and disengagement of the enlarged distal end portion with the selective valving means of the catheter shaft. A torquer device is also provided by means of which the guide wire may be rotated relative to the catheter shaft for steering of the guide wire along a vascular pathway.