Abstract: Described are methods and systems for modifying vascular valves in order to reduce retrograde blood flow through the valves. Preferred methods include connecting vascular valve leaflets with at least one remodelable material, such that the valve leaflets become fused by the ingrowth of the patient's native tissue. Preferred remodelable materials include collagenous extracellular matrix material, such as small intestine submucosa.

Abstract: Valvulotome devices and methods are provided. Valvulotome devices include one or more valvulotome arms that have a u-shaped curved body with opposing arms and a base portion that extends between the arms. The valvulotome arm defines a notch open at one end on one of the arms and extending into the base portion of the u-shaped curved body. The notch defines an angled surface that provides a cutting edge. Methods of making valvulotome devices are also described.

Abstract: Medical devices for implantation in a body vessel, and methods of using and making the same, are provided. A medical device includes a support frame having struts and a weakened frame portion, and a remodelable material tensionably attached to the support frame. The weakened frame portion has a first configuration in which the support frame has a first outward radial force and a second configuration in which the support frame has a second, lesser outward radial force. The remodellable material restricts expansion of the frame from a radially compressed configuration to a radially expanded configuration when the weakened frame portion is in the first configuration. The remodelable material can form one or more valve leaflets adapted to regulate fluid flow in a body vessel, such as a vein.

Abstract: Described are devices, methods and systems useful for achieving occlusion of vascular vessels. Percutaneous procedures can be used to occlude and obliterate the greater saphenous vein, for example in the treatment of varicose vein condition caused by venous reflux. Certain embodiments encompass the deployment and filling of an inflatable occlusion device via a percutaneous procedure, so as to occlude or obliterate a portion of a vascular vessel.

Abstract: An expandable venous valve having a support structure configured to enlarge the area adjacent the valve structure. The enlarged pocket areas can be created by forming an artificial sinus adjacent the valve structure in an unsupported section of vessel wall between two support frame sections.

Abstract: A universal needle guide is disclosed comprising a body, a first needle aperture and a second needle aperture. The body includes an upper support portion and at least one attachment portion. The first needle aperture defines a first diameter disposed in the upper support portion. The second needle aperture defines a second diameter that is selectively alignable with the first needle aperture. The second diameter is smaller than the first diameter.

Abstract: Valvulotome devices comprising a cutting edge are provided. Some valvulotome devices incisably engage a venous valve leaflet within a body vessel while at least a portion of the cutting edge is oriented substantially parallel to the longitudinal axis of the valvulotome device. Valvulotome devices are preferably configured to slidably engage a venous valve leaflet upon translation of the valvulotome device along the longitudinal axis of a body vessel. A valvulotome device can further comprise one or more valvulotome arms of variable lengths and dimensions. In some embodiments, the valvulotome device can be self expanding. Embodiments of the invention also provide delivery systems comprising a valvulotome device. The present invention also provides for methods of using a valvulotome device. Kits comprising a valvulotome device are also provided.

Abstract: Delivery systems, methods of making delivery systems, and methods of treatment are provided. A delivery system according to the invention facilitates a visual inspection of an intraluminal medical device included in the delivery system.

Abstract: An introducer assembly is disclosed. The introducer assembly comprises an introducer cannula, an introducer hub and an introducer stylet body. The introducer cannula is defined by a distal end and a proximal end and has a lumen extending therebetween. The introducer hub is operatively connected to the introducer cannula, and wherein the introducer hub is configured for selective connection with multiple medical devices. The introducer stylet body is defined by a proximal end and a distal end and is removably disposed within the introducer cannula. The introducer stylet body may further comprise an imagable feature having a predetermined size disposed on a distal end thereof.

Abstract: Implantable frames for use in body passages are provided herein. The implantable frames can include a plurality of hoop members joined by a plurality of longitudinal connecting members to form a tubular frame defining a cylindrical lumen. The plurality of longitudinal connecting members may include first and second longitudinal connecting members joining a first hoop member to a second hoop member such that the first and second longitudinal connecting members extend across an entire space separating the first and second hoop members.

Abstract: Prosthetic valves for implantation in a body vessel are provided. Prosthetic valves according to the invention comprise first and second frame members and a graft member at least partially disposed between the first and second frame members. The graft member forms a valve that permits fluid flow through the body vessel in a first direction and substantially prevents fluid flow through the body vessel in a second, opposite direction.

Abstract: Methods of implanting a prosthetic valve in a body vessel are provided. A first expandable frame member is delivered to and deployed at a point of treatment in a body vessel. A second expandable frame member is delivered to the point of treatment. The second expandable frame member has an attached graft member that forms a valve adapted to permit fluid flow through the body vessel in a first direction and to substantially prevent fluid flow through the body vessel in a second, opposite direction. After deployment of the first expandable frame member, the second expandable frame member is deployed at the point of treatment such that the second frame member is positioned radially inward of the first frame member within said body vessel to form a prosthetic valve.

Abstract: An valve prosthesis, such as an artificial venous valve, having a support frame and leaf structure comprising one or more leaflets in which the outer edge of each leaflet engages the inner circumference of the bodily passageway along a serpentine path urged against the passageway by an expandable frame, while the inner edges move in response to fluid to restrict retrograde flow. Optionally, one or more elements can extend from the support frame/leaf structure to provide centering support and/or protection from the leaflet adhering to the vessel wall. In one embodiment, the centering support structure comprises a second or third expandable frames attached to and extending from the proximal and/or distal ends of main valve structure and support frame. In another embodiment, one or more support elements extend outward from the valve support frame to engage the vessel wall to provide greater longitudinal stability.

Abstract: Medical devices for implantation in a body vessel are provided. Each medical device comprises a main body, a valve, and a vessel engaging member. The vessel engaging member is disposed on an outer surface of the main body. Kits including a plurality of vessel engaging members for use with one or more valve members are also provided. The vessel engaging members have varying radial dimensions, allowing assembly of medical devices having varying radial dimensions. Methods of treating a patient using medical devices according to the invention are also provided.

Abstract: Implantable medical devices comprising a support frame and a graft member attached to the support frame. The support frame can define one or more structural features that substantially prevent migration of the graft member along the support frame.

Abstract: Implantable frames for use in body passages are provided herein. The implantable frames comprise one or more of certain preferred structural features that are generally applicable to frames comprising a plurality of curved and straight member portions that together define an interior lumen extending along a longitudinal axis between a proximal end and a distal end. The implantable frames have an exterior surface comprising a plurality of openings between the interior lumen and the exterior surface, and preferably include one or more undulating hoop members attached to one or more longitudinal connecting members. The implantable frames can be formed from any suitable material, but preferably comprise material permitting the frame to radially self-expand from a radially compressed configuration to a radially expanded configuration. The implantable frames are useful for endolumenal implantation within a body vessel, for example as a stent or as a support frame of an implantable valve.

Abstract: Implantable medical devices comprising a support frame and a graft member attached to the support frame. The support frame can define one or more structural features that substantially prevent migration of the graft member along the support frame.

Abstract: Medical devices for implantation in a body vessel, and methods of using and making the same, are provided. Embodiments of the invention relate to medical devices comprising a frame having cross-section that can substantially conform to body vessel shapes that have elliptical or circular cross-sections, and dynamically respond to changes in the cross-section of a body vessel. Frames with directionally-dependent radial compressibility or expandability characteristics are also provided. Medical devices comprising a frame and one or more valve members adapted to regulate fluid flow in a body vessel, such as a vein, are also provided.

Abstract: Medical devices for implantation in a body vessel are provided. Each medical device comprises a main body, a valve, and a vessel engaging member. The vessel engaging member is disposed on an outer surface of the main body. Kits including a plurality of vessel engaging members for use with one or more valve members are also provided. The vessel engaging members have varying radial dimensions, allowing assembly of medical devices having varying radial dimensions. Methods of treating a patient using medical devices according to the invention are also provided.

Abstract: An valve prosthesis, such as an artificial venous valve, having a support frame and leaf structure comprising one or more leaflets in which the outer edge of each leaflet engages the inner circumference of the bodily passageway along a serpentine path urged against the passageway by an expandable frame, while the inner edges move in response to fluid to restrict retrograde flow. Optionally, one or more elements can extend from the support frame/leaf structure to provide centering support and/or protection from the leaflet adhering to the vessel wall. In one embodiment, the centering support structure comprises a second or third expandable frames attached to and extending from the proximal and/or distal ends of main valve structure and support frame. In another embodiment, one or more support elements extend outward from the valve support frame to engage the vessel wall to provide greater longitudinal stability.