Abstract: Medical devices for implantation in a body vessel are provided. A medical device according to the invention comprises a support structure and one or more graft members comprising a valve portion and a constraining portion. The support structure has a first, unexpanded configuration and a second, expanded configuration. The constraining portion is adapted to substantially prevent the support structure from achieving the second, expanded configuration. The valve portion is adapted to permit fluid flow through a body vessel in a first direction and substantially prevent fluid flow through the vessel in a second, opposite direction.

Abstract: A system and method for occluding an aneurysm formed in a dilatation area of a body vessel are disclosed. The system comprises a wire guide, a core wire, and an occlusion device. The wire guide comprises a proximal end and a distal end, and has a passageway that extends from the proximal end to the distal end. The core wire comprises a distal end and a proximal end, and is disposed through the passageway so that the proximal end of the core wire proximally extends beyond the proximal end of the wire guide. The occlusion device comprises a distal end and a proximal end, and has a deployed state and an undeployed state. The occlusion device has a pre-set spiraled coil shape when in the deployed state in the vessel. The occlusion device is disposed distally from the core wire in the passageway.

Abstract: A device and method for opening a substantially flat external flange of an indwelling catheter. The device is a one-piece elongated member having configured ends formed by bending the elongated member so that one configured end is positioned slightly above the other configured end by passing the second configured end through an aperture formed inside of the member. In addition, an apparatus comprising at least the opening device and an indwelling catheter having a flat external flange is disclosed. Other embodiments of opening devices constructed and arranged to open the external flange of an indwelling catheter are also contemplated. The device is used to maintain the low profile of the external flange of the indwelling catheter and to prevent damage to the skin or body tissue surrounding the catheter flange.

Abstract: A high performance wire guide is disclosed, having a core wire and an outer member disposed about the core wire for enhanced torque transmission along a longitudinal length of the core wire. The outer member may be an outer coil wrapped around the core wire in an interference fit.

Abstract: A thrombi removal device includes a shaft with a distal end and a proximal end and a helical coil attached at one end to the distal end of the shaft and extending in the distal direction from the shaft. The coil has a plurality of body portions with turns or winding spaced apart longitudinally and laterally to facilitate screwing the coil into the thrombus and to provide a sufficient open area into which the thrombus can be captured. The distal end of the coil is provided with a loop. The angle of the loop relative to a longitudinal axis extending through the helical coil is about the same as the angle of at least one body portion.

Abstract: Disclosed is a stent graft prosthesis comprising a graft portion that includes a main body portion and an cuff portion, the cuff portion generally located at or near the proximal end of the main body portion and extending circumferentially therealong. Stents comprising the graft supporting structure are also attached to graft portion about the proximal end. In one embodiment, the cuff portion comprises material that is folded over the outside surface of the main body portion with an anchoring stent being attached over the cuff and main body portions, extending proximally therefrom. In another series of embodiments, the cuff portion comprises an external sealing zone that extends around the outer main body portion to help prevent leakage of fluids. In one example, the material of the second edge of the cuff portion is frayed to better engage the vessel walls and promote thrombus and/or tissue growth.

Abstract: An iris-type valve assembly comprises a base, a rotatable member, and an elongated elastomeric valve sheath. The distal end of the valve sheath is secured to the base, and the proximal end of the valve sheath is secured to the rotatable member. At least one of the valve sheath ends includes a flange that is secured to a valve-receiving surface of the base or the rotatable member. The base and the rotatable member are aligned to define a passageway therethrough for passage of an interventional device. The valve sheath is disposed along the passageway and has a longitudinal opening therethrough for passage of the interventional device. Upon rotation of the rotatable member relative to the base, the longitudinal opening of the valve sheath is selectively constrictable to comprise a seal around the interventional device.

Abstract: The present invention involves a removable filter for capturing thrombi in a blood vessel. The filter comprises a plurality of primary struts and a plurality of secondary struts. The plurality of primary struts has first ends attached together along a longitudinal axis. Each primary strut has an arcuate segment extending from the first end to an anchoring hook. The primary struts are configured to move between an expanded state for engaging the anchoring hooks with the blood vessel and a collapsed state for filter retrieval or delivery. Each primary strut is configured to cross another primary strut along the longitudinal axis in the collapsed state such that each anchoring hook faces the longitudinal axis away from the blood vessel for filter retrieval or delivery. The plurality of secondary struts has connected ends attached together along the longitudinal axis. The secondary struts extend therefrom to free ends to centralize the filter in the expanded in the blood vessel.

Abstract: Delivery systems for self-expanding devices are provided having a system proximal portion with a handle, an elongate middle section delivery device with an outer sheath and inner compression member, and a system distal portion including an outer guide channel member with first and second end portions defining a guide channel that slidably receives an inner guide channel member having a guide channel, the guide channels being substantially aligned. A mounting region for self-expanding devices is disposed radially between the inner and outer guide channel members. The outer guide channel member has a stepped profile from a first outer diameter to a second smaller outer diameter located near a transition region having a breech position opening for passage of a wire guide, catheter, or other medical instrument. The outer member is axially slideable relative to the inner member to deploy a self-expanding device. Methods of using and manufacturing are also provided.

Abstract: Medical devices for implantation in a body vessel are provided. A medical device according to the invention comprises a support structure and one or more graft members comprising a valve portion and a constraining portion. The support structure has a first, unexpanded configuration and a second, expanded configuration. The constraining portion is adapted to substantially prevent the support structure from achieving the second, expanded configuration. The valve portion is adapted to permit fluid flow through a body vessel in a first direction and substantially prevent fluid flow through the vessel in a second, opposite direction.

Abstract: A prosthetic valve device, a method for making a valve device, and a method for implanting a valve device into a recipient are provided. The valve device includes at least one flexible member formed at least partially from a woven layer. The woven layer includes a first material and a second material being at least partially woven together. The at least one flexible member is movable between a first position that permits fluid flow in a first direction and a second position that substantially prevents fluid flow in a second direction. The valve has a first, unexpanded configuration and a second, expanded configuration.

Abstract: Prosthetic valve devices for implantation in body vessels are provided. The prosthetic valve device includes at least one flexible member that permits fluid flow in a first direction and substantially prevents fluid flow in a second. The valve device also includes an inflatable chamber at least partially attached to the flexible member. The inflatable chamber is adapted to receive inflating media and is adapted to contact the body vessel. A delivery system is also provided that includes a valve device and a delivery apparatus. The delivery apparatus includes a member adapted for filling the chamber of the valve device with inflating media. A related method of making the valve device is also provided.

Abstract: Described are vascular valve devices having valve elements formed of flexible material and at least one removable frame element. Also described are methods for using such devices in the vascular system and in particular in the venous system to treat venous insufficiency.

Abstract: An introducer sheath has an inner fluorocarbon liner, a reinforcing member disposed radially outwardly from the liner, and a polymeric intermediate layer positioned longitudinally over the reinforcing member and inner liner. A heat shrink layer formed of a block copolymer having cross-linked and non-cross-linked functional groups comprises an outer layer of the sheath. During for of the introducer sheath, the intermediate layer is melted and compressed in the heat shrink layer in a manner such that the inner surface of the intermediate layer bonds to the outer surface of the inner liner through spacings of the reinforcing member, and the outer surface of the intermediate layer bonds with non-cross-linked active functional groups of the heat shrink layer.

Abstract: An embolic protection device generally includes an elongated hub and at least one projection. The projection defines a tortuous pathway between the hub and the vessel wall to prevent emboli from following the pathway and passing beyond the device. The tortuous pathway is structured to permit the bodily fluid to follow the pathway and pass beyond the device.

Abstract: A barbed medical prosthesis is disclosed in which the barb includes a basal portion comprising a point of union with the substrate of origin (such as a strut), an anchoring portion adapted to embed into tissue, and a stress-dispersing portion located between the basal and anchoring portions. In one embodiment the stress-dispersing portion comprises a helical coil having a free winding that is unattached to the strut from which the barb extends. In another embodiment, the stress-dispersing portion comprises a series of bends or curves formed in the barb proximate to the point of union with the strut. The barb can be mechanically attached and/or soldered to the prosthesis, or integrally formed therefrom. A second barb portion and stress-dispersing portion, may also extend from the basal portion.

Abstract: A multiple-sided medical device comprises a frame comprising wire or other resilient material and having a series of bends and interconnecting sides. The device has both a flat configuration and a second, folded configuration which a generally serpentine shape. The device is pushed from a delivery catheter into the lumen of a duct or vessel and may include one or more barbs for anchoring purposes. A full or partial covering of fabric or other flexible material such as DACRON, PTFE, or a collagen-based material such as small intestinal submucosa (SIS), may be sutured or attached to the frame using heat or pressure welding crimping, adhesive, or other techniques to form an occlusion device, a stent graft, or an implantable, intraluminal valve such as for correcting incompetent veins in the lower legs and feet.

Abstract: A delivery system, including a balloon catheter having a balloon with distal and proximal ends and a guide catheter for delivering the balloon catheter to a treatment site, is disclosed. The balloon tapers from at least one of the distal and proximal ends of the balloon to an active region on the surface of the balloon. The active region has a diameter D1 which is greater than a diameter of the balloon at one or more of the distal and proximal ends of the balloon. Preferably, one or more of the lengths L1, which is the distance from the proximal end of the balloon to the active region, and L2, which is the distance from the distal end of the balloon to the active region, are between three to thirty times the diameter D1.

Abstract: Medical devices with one or more bioactive agents are provided for regulating fluid flow through a body vessel. Medical devices according to the invention can comprise prosthetic valves that include a bioactive agent.

Abstract: An apparatus for providing percutaneous access to a vessel of a patient over a wire guide. An outer sleeve of the apparatus has proximal and distal open ends, and has a lumen extending longitudinally therethrough. An inner sleeve has proximal and distal open ends, and has a lumen extending longitudinally therethrough. The inner sleeve is sized to be received within the lumen of the outer sleeve. The inner sleeve has a main body portion having a distal portion that tapers toward its distal open end. The tapered distal portion extends distal to the distal open end of the outer sleeve to provide a generally smooth diametrical transition between the outer sleeve and the wire guide. A more rigid stiffening cannula has proximal and distal open ends, and has a lumen extending longitudinally therethrough. The lumen of the stiffening cannula is sized to receive the wire guide therethrough.