Abstract: A device and a method for preparing foam are provided. The device includes a first housing having a first chamber therein and a first movable member positioned at least partially within the first housing. The device also includes a second housing having a second chamber therein, the second chamber being selectively and operably connectable to the first chamber. The second housing further includes a biasing member and a second movable member therein, the biasing member biasing the movable member toward a first end portion of the second housing. The device includes a valve operably connected to the first chamber and the second chamber and movably positionable to selectively control the connection between the first chamber and the second chamber and a handle operably connected to the first movable member and movable to bias the first movable member toward a first end portion of the first housing.

Abstract: A stent graft introducer (1) has a distally opening capsule (5) on a nose cone dilator (3) and a plug device (17; 53) in the capsule. The plug device (17; 53) is movable longitudinally within the capsule (5) to move to a distal end (7) of the capsule (5) to extend from the capsule (5) whereby to provide a smooth transition from the otherwise distal opening (7) of the capsule (5) to enable retraction of the nose cone dilator (3) through a deployed stent graft (35). The capsule (5) includes an in-turned distal end (7) and the plug device (17; 53) has a proximal shoulder (25) whereby to prevent the plug device (17; 53) from being completely as withdrawn from the capsule (5). The plug device (17; 53) has a distal linearly tapered surface (27) or a distally facing bullet shaped surface (57). There can be an arrangement (72; 80) to prevent subsequent retraction of the plug device (53; 17).

Abstract: An introducer assembly (10) includes a balloon catheter (12) for deploying a medical device (19) in a body lumen or for dilating a body lumen at a range of diameters from a minimum deployment diameter to a maximum deployment diameter. The balloon catheter includes an outer balloon (42) and an inner balloon (40) located within the outer balloon (42). The outer balloon (42) has an unstretched diameter equivalent to the minimum deployment diameter and the inner balloon (40) has an unstretched diameter equivalent to the maximum deployment diameter. The outer balloon (42) is made of an elastic material able to stretch from the minimum deployment diameter to the maximum deployment diameter, while the inner balloon (40) is preferably of an non-compliant material.

Abstract: A stent graft (40) for treating Type-A dissections in the ascending aorta (22) is provided with a plurality of diameter reducing suture loops (56-60) operable to constrain the stent graft during deployment thereof in a patient's aorta. The diameter reducing loops (56-60) allow the stent graft (40) to be partially deployed, in such a manner that its location can be precisely adjusted in the patient's lumen. In this manner, the stent graft can be placed just by the coronary arteries (26, 28) with confidence that these will not be blocked. The stent graft (40) is also provided with proximal and distal bare stents (44,52) for anchoring purposes.

Abstract: An apparatus for an improved high pressure medicinal dispenser is disclosed. The high pressure dispenser may include a handle (26), a chamber (18), a threaded region, a threaded rod (14), and a knob (20). The high pressure dispenser may have at least one insert-molded component. A threaded insert providing the threaded region may be insert-molded into the handle or the threaded rod may be insert-molded into the knob, or both. The dispenser may have a handle made of hard plastic and overmolded soft rubber material. The dispenser also may have a ribbed knob having at least one longitudinal rectangular cavity. Furthermore, the dispenser may have a chamber that has an interior concave surface and an interior convex surface between the interior cylindrical surface of the chamber and a nozzle. The chamber may have at least one tab or notch dimensioned to engage with at least one corresponding notch or tab on the handle.

Abstract: A catheter device including an elongate tubular shaft having a consistent material composition for a substantial proportion of its length. The device includes a proximal shaft portion having a first flexibility and a distal shaft portion having a second flexibility, wherein the second flexibility is greater than the first flexibility and wherein at least the distal shaft portion comprises at least one score in a surface thereof. The device includes a wholly external wire guide structure secured to the tubular shaft by a figure-eight polymer sleeve.

Abstract: A nickel-titanium-rare earth (Ni—Ti-RE) alloy comprises nickel at a concentration of from about 35 at. % to about 65 at. %, a rare earth element at a concentration of from about 1.5 at. % to about 15 at. %, boron at a concentration of up to about 0.1 at. %, with the balance of the alloy being titanium. In addition to enhanced radiopacity compared to binary Ni—Ti alloys and improved workability, the Ni—Ti-RE alloy preferably exhibits superelastic behavior. A method of processing a Ni—Ti-RE alloy includes providing a nickel-titanium-rare earth alloy comprising nickel at a concentration of from about 35 at. % to about 65 at. %, a rare earth element at a concentration of from about 1.5 at. % to about 15 at. %, the balance being titanium; heating the alloy in a homogenization temperature range below a critical temperature; and forming spheroids of a rare earth-rich second phase in the alloy while in the homogenization temperature range.

Abstract: A stent graft (40) for treating Type-A dissections in the ascending aorta (22) is provided with a plurality of diameter reducing suture loops (56-60) operable to constrain the stent graft during deployment thereof in a patient's aorta. The diameter reducing loops (56-60) allow the stent graft (40) to be partially deployed, in such a manner that its location can be precisely adjusted in the patient's lumen. In this manner, the stent graft can be placed just by the coronary arteries (26, 28) with confidence that these will not be blocked. The stent graft (40) is also provided with proximal and distal bare stents (44,52) for anchoring purposes.

Abstract: Various stents and stent-graft systems for treatment of medical conditions are disclosed. In one embodiment, an exemplary stent-graft system may be used for endovascular treatment of a thoracic aortic aneurysm. The stent-graft system may comprise proximal and distal components, each comprising a graft having proximal and distal ends, where upon deployment the proximal and distal components at least partially overlap with one another to provide a fluid passageway therebetween. The proximal component may comprise a proximal stent having a plurality of proximal and distal apices connected by a plurality of generally straight portions, where a radius of curvature of at least one of the proximal apices may be greater than the radius of curvature of at least one of the distal apices. The distal component may comprise a proximal z-stent coupled to the graft, where the proximal end of the graft comprises at least scallop formed therein that generally follows the shape of the proximal z-stent.

Abstract: A magnetically opaque medical device is disclosed wherein a contrast agent is incorporated into the actual device. The medical device is generally comprised of a base material forming the structure of the device and a contrast agent, such as tocopherol and tocopherol derivative solutions or suspensions, gadolinium, or nickel sulfate integrated into the base material itself or posited on a substantial portion of an exterior surface of the device. The device may include other additional functional agents and layers.

Abstract: This disclosure relates to implantable medical devices coated with a taxane therapeutic agent, such as paclitaxel, in one or more solid form(s) having varying dissolution rates. Particularly preferred coatings comprise amorphous and/or solvated solid forms of taxane therapeutic agents that provide durable coatings that release the taxane over a desired period of time, which can be varied in the absence of a polymer by selecting the type and amount of solid forms of the taxane therapeutic agent in the coating. Other preferred embodiments relate to methods of coating medical devices and methods of treatment. The coatings can provide a sustained release of the taxane therapeutic agent within a body vessel without containing a polymer to achieve the desired rate of paclitaxel elution.

Abstract: A stent graft (10) has a tubular body (12) of a biocompatible material and at least one fenestration (18, 20). The or each fenestration has a tubular side branch stitched into it with a portion of the tubular side branch extending within the tubular body and a portion of the tubular side branch extending exteriorly of the tubular body. The stitching by which the tubular side branch is mounted into the fenestration extends circumferentially and diagonally from one end of the tubular side branch to the other such that the tubular side branch extends from the tubular body at an angle thereto. The tubular side branch has a resilient ring around at least one and preferably both ends thereof and a self expanding stent in between them. The tubular side branch can have a circumferential linear portion (46) at an inner end to engage against the inner wall (58) of the tubular body.

Abstract: A stent tissue graft prosthesis (20) for repairing, excluding and/or reinforcing a vessel, duct and the like in a patient. The prosthesis includes an inner expandable stent (21) of which a tissue graft (24) and preferably a multilayered tissue construct (33) is disposed thereon for application to the host tissue of a vessel, duct and the like. The tissue construct includes an extracellular matrix material (36) such as small intestine submucosa (37) for remodeling the host tissue into the prosthesis. The prosthesis further includes an outer tubular member (25) such as an outer expandable stent (44) for retaining the tissue graft on the inner stent. The ends of the inner and outer stents are coincident with or extend beyond the ends of the tissue graft to prevent eversion or fold back of the tissue graft during withdrawal of a delivery catheter in a placement procedure.

Abstract: An embolization system having a high packing fraction of embolic particles for use in occluding the flow of body fluid through a body vessel and a method for using such an embolization system are described. The embolic particles, which are made from a shape memory material, exhibit both a collapsed state and an expanded state. The embolic particles exhibit at least a bimodal particle diameter distribution in the collapsed state and expanded state with a particle packing fraction of at least about 0.85. The mixture of embolic particles is delivered into the body vessel in the collapsed state. The particle packing fraction of the mixture in its expanded state causes the occlusion of the flow of body fluid through the body vessel.

Abstract: A stent graft (10) is retained on an introducer (38) by retention of an exposed stent (16) of the stent graft to the introducer with trigger wires (44). The introducer has a trigger wire catheter (40) and four trigger wires and each trigger wire extending in a loop from the trigger wire catheter. The stent graft has a tubular body (12) of a graft material and an exposed stent joined to and extending from one end of the tubular body. The exposed stent is a self expanding Z stent with struts (20) and bends (22, 28, 30) between them. A pair of struts and a bend between define an apex a selected distance to the bend away from the tubular body. Adjacent apices of the exposed stent are different distances to the bends from the tubular body so that they stack under the trigger wires in an neat fashion. Distally extending barbs (26) on alternate struts of the exposed stent are spaced selected distances from their respective apices to prevent tangling during deployment.

Abstract: Medical devices, and methods of use therewith, suitable for at least partial implantation within the gastrointestinal portions of a body and having at least one anti-gastric distress agent are provided. The anti-gastric distress agent can include antacids, H2 blockers, proton pump inhibitors, or any combination thereof. The medical device can also include one or more sections having one or more anti-gastric distress agent or antimicrobial agents. The medical device has a length such that when the device is at least partially implanted the first section is accessible to the gastrointestinal portion of the patient's body. A second section having an antimicrobial agent may be external to the gastrointestinal portion. Preferably, device includes a first and second anti-gastric distress agent each having a different controlled release rate. The therapeutic agents can be disposed on one or more surfaces of the medical device and/or impregnated with the material of the medical device.

Abstract: A stent constructed from at least two individual monolithic stent units is provided. The stent includes at least two individual stent units. Each individual stent unit has, as a monolithic structure, a first strut, a second strut, and a third strut. A first apex adjoins the first and second struts, and a second apex adjoining the second and third struts, where the second apex is disposed in a direction generally opposite the first apex. The monolithic stent unit includes an attachment mechanism at the end of at least the first strut. The first strut of each monolithic stent unit is joined at an attachment point to the third strut of an adjacent monolithic stent unit. The attachment mechanism is bent to form an angle relative to the attachment point. A method of manufacturing the same stent also is provided.

Abstract: This invention relates in one aspect to the treatment of a vascular vessel with a biomaterial. The biomaterial can be a remodelable material that strengthens and/or supports the vessel walls. Additionally the biomaterial can include a variety of naturally occurring or added bioactive agents and/or viable cellular populations.

Abstract: There is disclosed a drug eluting balloon catheter assembly provided with a balloon formed of an inner balloon member of non-compliant material and an outer balloon member of a compliant material and which is provided with holes therein for eluting a drug or other fluid. In use, the outer balloon member is biased by contraction onto the inner balloon member thereby keeping the holes therein normally sealed closed and minimizing dead space in the device.

Abstract: A flexible stent having a waveform pattern formed from a sheet of biocompatible material and into a tubular shape for maintaining the patency of a lumen such as in a coronary vessel. The waveform pattern of the stent is formed from a flat sheet of malleable, biocompatible material by, for example, photochemically etching the sheet biocompatible material and leaving a framework or plurality of closed cells. The waveform pattern is formed into a tubular shape around a deflated, delivery catheter balloon with segments of the closed cells being interposed only overlapping a reinforcing member extending longitudinally along the stent. The stent material is treated to reduce the coefficient of friction of the material and to aid in the radial expansion of the stent with the balloon. Radiopaque markers are positioned at the ends of the stent to aid the physician in positioning the stent at an occlusion site.