Abstract: A multiple lumen catheter having a soft, tapered multiple lumen distal tip for insertion into a body vessel. One of the lumens is sized to pass over a guidewire such that the catheter can be inserted into the body vessel using the Seldinger technique. At least one medical implement lumen is used for placement or positioning of a biomedical sensor or other medical implement. For example, at least one optical fiber passing through the medical implement lumen may transmit and receive light at the distal tip for measuring oxygen saturation of the blood. The catheter may have a cylindrical catheter body to which the soft distal tip attaches. The soft tip reduces the possibility of vessel or tissue puncture and abrasion. The tip is constructed of a soft plastic or pliable material that yields easily when force is applied.

Abstract: An introducer having an elongate tubular member and a device connector releasably attached to a proximal end of the tubular member. The introducer allows exchange of medical instruments, such as a blood filter and cardioplegia catheter, through a single lumen. An obturator having a retractable blade for making incision on a tissue is insertable through the lumen of the introducer. Methods of using the obturator and the introducer for introducing medical device(s) into body cavity, such as a vessel or cardiac tissue, are also disclosed.

Abstract: A medical device comprising a tubular member having a proximal end, a distal end, and a lumen extending therebetween. An adjustable filter is provided having a frame and a mesh disposed about the frame. The frame is generally circular when deployed and has a first point, a first arc extending 180° from the first point to a second point on the circular frame that is opposite the first point, and a second arc extending 180° from the first point to the second point. The filter is deployed by advancing the frame distally through the tubular member with the second point leading and the first point trailing.

Abstract: Devices and methods for filtering blood. The devices generally comprise 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, and a means to actuate the structure. The methods generally include the steps of introducing a mesh into a blood vessel to entrap embolic material, and removing the mesh and the entrapped foreign matter from the blood vessel.

Abstract: A multiple lumen catheter having a soft, tapered multiple lumen distal tip for insertion into a body vessel. One of the lumens is sized to pass over a guidewire such that the catheter can be inserted into the body vessel using the Seldinger technique. At least one medical implement lumen is used for placement or positioning of a biomedical sensor or other medical implement. For example, at least one optical fiber passing through the medical implement lumen may transmit and receive light at the distal tip for measuring oxygen saturation of the blood. The catheter may have a cylindrical catheter body to which the soft distal tip attaches. The soft tip reduces the possibility of vessel or tissue puncture and abrasion. The tip is constructed of a soft plastic or pliable material that yields easily when force is applied.

Abstract: The invention provides methods for treating injuries to one or more internal structures of a subject by administering a drug delivery vehicle to an external surface of the injured structure. The drug delivery vehicle substantially adheres to the site of administration and provides for the release of a bioactive agent that reduces or prevents further injury to the internal structure by disease processes, such as hyperplasia.

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 medical device for filtering embolic material. The device comprises a cannula having a lumen, the lumen communicating with a port at the distal end. A port is located on an outer surface of the cannula adjacent a distal region of the cannula, the port having a passage extending distally and communicating with a distal opening in the port. A filter is removably insertable through the passage of the port, the filter comprising a flexible tubular member, a flexible shaft extending through the tubular member, and an expansion frame mounted on the distal end of the shaft. A filter mesh attached to the expansion frame. The expansion frame may optionally include a cantilever beam to support the far end of the frame, and in certain cases the cantilever beam is flexible to avoid scraping the vessel wall during use. Methods of use are also described.

Abstract: A method of making a cannula includes providing a plurality of polymer reservoirs with each reservoir containing a polymer material and providing a nozzle mounted within each reservoir of the plurality of reservoirs. The method further includes one or more of preheating the mandrel, generating a polymer material wave from each nozzle, rotating the mandrel over the nozzles to form an initial coat on the mandrel, curing the initial coat, depositing a reinforcing material around a selected section of the mandrel and ensuring that the reinforcing material is held in place at the selected section of the mandrel. The method further includes rotating each section of the mandrel over a selected nozzle to form an additional coat, curing the additional coat, and removing the tubular structure from the mandrel.

Abstract: A method of making a cannula utilizing dispense molding includes providing at least one dispense nozzle that dispenses a polymer material, providing a mandrel, moving at least one of the mandrel and at least one dispense nozzle relative to one another to produce an alternating pattern of polymer material along a longitudinal axis of the mandrel to form a tubular structure, and removing the tubular structure from the mandrel.

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: A multiple lumen access device for use in providing a single entry port into the human body for selectively introducing medical implements therethrough and for providing simultaneous auxiliary access into the body. The multiple lumen access device includes a multi-lumen sheath which may have an outer tube and structure defining a device lumen located therein. The inner structure may be an inner wall or inner tube. The outer tube and inner structure are located so as to define at least one auxiliary lumen. Some embodiments include flexible inner walls which can be flexed between relaxed and expanded/contracted positions wherein the relative cross-sectional areas of the device lumen and auxiliary lumens are varied. The access device further includes a valve which provides sealing of the device lumen. The valve may be provided in a lumen junction housing or separate from the housing either permanently or removably connected with the device lumen.

Abstract: An intravascular device for venting an inflatable chamber and methods for using the device are disclosed. The intravascular device generally includes three components, namely a catheter or cannula, an inflatable member, and a selective degassing element. The inflatable member is typically a balloon. The catheter or cannula is typically hollow with a first lumen extending between an inflation port and the interior of the inflatable member and a second lumen extending between the interior of the inflatable member and an exhaust port. The selective degassing element is typically positioned between the inflatable member and the exhaust port and occupies the entire cross-sectional area of the second lumen. When in a closed position, the selective element prevents the passage of liquid from the interior of the inflatable member, through the exhaust port. When in an open position, the selective element permits gas entrained within the inflatable member to be expelled from the device, via the exhaust port.

Abstract: The invention provides methods for treating injuries to one or more internal structures of a subject by administering a drug delivery vehicle to an external surface of the injured structure. The drug delivery vehicle substantially adheres to the site of administration and provides for the release of a bioactive agent that reduces or prevents further injury to the internal structure by disease processes, such as hyperplasia.

Abstract: A catheter-based material removal device includes an elongated tube having a distal material removal tip thereon. The material removal tip includes a one- or two-piece housing affixed to the tube, and a rotating member therein. The rotating member includes a screw thread for coarsely chopping material received within the housing and an outwardly projecting flange for finely chopping the material. The housing includes at least one shearing member located axially adjacent the outwardly projecting flange. The shearing member has a relatively small circumferential size and a shearing edge that removes any material buildup on the axially-facing surface of the flange. Two shearing members may be provided, one each on both the proximal and distal sides of the flange. There may be three flanges restrained within a groove formed with the housing.

Abstract: A controlled advancement laser ablation device is provided for precise ablation of body matter. The laser ablation device includes a laser energy transmission mechanism such as, e.g. a fiber optic fiber mounted for controlled translational longitudinal movement relative to a housing structure. A laser energy generator is optically connected to the laser energy transmission mechanism. A controlled advancement mechanism is provided in engagement with the laser energy transmission mechanism for advancing the mechanism through the housing structure at a controlled rated coordinated with the laser energy generator output to ablate body tissue. Controlled advancement mechanisms include constant and/or variable rate springs, motors, and other mechanisms which can be coordinated with the laser energy generator to advance the laser energy transmission mechanism as the targeted substance is ablated. The device is particularly suitable for use in transmyocardial revascularization (TMR) and angioplasty procedures.

Abstract: A graft forming apparatus and method including a plurality of mandrels for receiving tubular grafts thereon and an adjacent cutting instrument for forming regular and repeated patterns of small holes therein and for severing the ends of the graft. The cutting instrument is preferably a low-powered laser to form clean and non-frayed holes and lines in fabric grafts. The mandrel are mounted for rotation about an axis underneath the cutting instrument which is movable along the axis. By computer control, the motion of the cutting instrument and mandrel can be accurately and precisely choreographed. The mandrel may be a straight cylinder for forming straight grafts, or may be a bifurcated mandrel formed of several components. The bifurcated mandrel includes a trunk portion and pair of detachable leg portions. Adapter disks are provided so that the bifurcated mandrel can be rotated either about the axis of the trunk portion, or about the axis of one of the leg portions.

Abstract: A catheter-based material removal device includes an elongated tube having a distal material removal tip thereon. The material removal tip includes a one- or two-piece housing affixed to the tube, and a rotating member therein. The rotating member includes a screw thread for coarsely chopping material received within the housing and an outwardly projecting flange for finely chopping the material. The housing includes at least one shearing member located axially adjacent the outwardly projecting flange. The shearing member has a relatively small circumferential size and a shearing edge that removes any material buildup on the axially-facing surface of the flange. Two shearing members may be provided, one each on both the proximal and distal sides of the flange. There may be three flanges restrained within a groove formed with the housing.

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 method for positioning an intraluminal graft within a branching vessel in a patient's body is described. The method is particularly applicable to the appropriate positioning of a trouser graft so that it bridges an aneurism which extends from a single vessel, such as the aorta, into one or more divergent vessels, for example, an iliac artery. The method can comprise the steps a of placing a first graft (10), that bifurcates in a pair of tubular sections (19a, 19b) into the pre-branching portion of a vessel (11) through one of the post-branching portions of the vessel (12, 13), positioning a second tubular graft (10b) into one of the post-branching portions (12) and connecting it to one of the tubular sections of the first graft (19a), and positioning a third tubular graft (10a) into the other of the post-branching portions (11) and connecting it to the other of the tubular sections of the first graft (19b).