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 percutaneous delivery of an occlusion device inverted within a cannula, its deployment and filling, so as to occlude or obliterate a portion of a vascular vessel.

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: 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: A pressure injection syringe with an actuator that includes a plunger for pressurizing viscous fluid material within a chamber. The plunger distal tip includes a high pressure seal defined by a seal member within a seal seat. The high pressure seal is viscoselective to permit air passage therepast for aspiration, and to prohibit viscous material passage therepast during actuation of the actuator wherein high pressure is applied to the material within the chamber. The viscoselective seal may be defined for example by small axial openings in the seal seat that permit aspiration of air therepast during initial plunger insertion into the chamber, but fluid escape is prohibited by the seal member when the seal member is pressed firmly against a collar of the plunger proximally adjacent the seal seat by initial engagement of the seal member with the viscous material, thus completely sealing the chamber at the proximal end thereof.

Abstract: This invention relates in one aspect to the treatment of a valve-associated region 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: Delivery systems and methods of making delivery systems are provided. A delivery system according to the invention facilitates delivery of an intraluminal medical device to a point of treatment in a body vessel. A dilator includes a means for resisting relative movement between an associated intraluminal medical device and the dilator during relative movement between the dilator and an associated tubular member disposed about the dilator.

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: 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 a compliance that can change upon implantation of the medical device within the lumen of a body vessel. Controlled fracture or bioabsorption of frame material can, in some embodiments, increase the compliance of a frame after implantation. 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: A delivery system (10) for implanting a medical device (30) such as a venous valve into the vasculature of a patient. The delivery system includes a delivery catheter (11) having a device-containing portion (15) adjacent to the distal end (14) thereof, and an inner member (16) extending through the catheter and beyond the distal end thereof, to an atraumatic distal tip portion (17) forward of the catheter distal end. Delivery catheter (11) includes inner tube (122), flat wire coil (123) compression fitted therearound, and outer tube (112) mechanically connected to roughened outer surface (126) of the inner tube through the spacing of the coil. Delivery catheter (11) can be provided with a window (184) to allow fluoroscopic visualization of a stent valve within the delivery system.

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: 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: A venous valve prosthesis having a substantially non-expandable, valve portion comprising a valve-closing mechanism, such as a pair of opposing leaflets; and an anchoring portion, such as one or more self-expanding frames or stents that are expandable to anchor the prosthesis at the implantation site. In one embodiment, the rigid valve portion includes a deposition of material such as pyrolitic carbon to reduce the thrombogenecity of the blood-contacting surfaces. The anchoring portions preferably include a covering, such as a tubular construct of synthetic or collagen-derived material (such as a bioremodelable ECM material), which attaches about the support structure such that blood flow is directed through the valve mechanism as it transitions from the larger diameter anchoring portion to the intermediate, smaller-diameter portion of the prosthesis.

Abstract: A pressure injection syringe (10) with an actuator (100) that includes a plunger (102) for pressurizing viscous fluid material within a chamber (14). The plunger distal tip (112) includes a high pressure seal (110) defined by a seal member (118) within a seal seat (116). The high pressure seal (110) is viscoselective to permit air passage therepast for aspiration, and to prohibit viscous material passage therepast during actuation of the actuator wherein high pressure is applied to the material within the chamber (14).

Abstract: A guidewire with a flexible tip is provided. The flexible tip comprises a portion of a coating that axially extends beyond a distal end of an elongate member of the guidewire. The length of the flexible tip can be defined in relation to a diameter of the elongate member of the guidewire. Also, the length of the flexible tip can be defined in relation to a length of a distal tip portion of the elongate member of the guidewire. The flexible tip may include agents that facilitate visualization, such as an opacifying agent in the coating and/or a radiopaque marker disposed in the flexible tip.

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: Prosthetic valve devices for implantation in body vessels, and methods of making same, are provided. The device has a main body with first and second ends and defining a lumen, with the second end being inverted into the lumen. A valve is disposed at the second end. In multiple valve devices, valves are disposed at the first and second ends, and individually may be inverted into the lumen. The prosthetic valve devices may further include a support structure such as a stent. Methods of making a prosthetic valve device include providing a main body having first and second ends and defining a lumen, forming a valve at the second end, and inverting the second end into the lumen. Methods may further comprise forming multiple valves and may also include attaching a support structure.

Abstract: An expandable venous valve having a support structure that configured to enlarge the area adjacent to the valve structure such that the flow patterns of retrograde flow are modified in a way that facilitates the flushing of the pockets at the base of the valve area to prevent stagnation of bodily fluid, which in the venous system, can lead to thrombus formation. 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 section or the support frame can comprise an expanded-diameter intermediate or proximal section that forms an artificial sinus adjacent the valve structure.

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: 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: Methods and devices for delivering and deploying expandable intraluminal medical devices at a desired point of treatment within a body vessel are provided. A portion of a delivery device is spaced from an interior wall surface of the body vessel prior to deployment of the expandable intraluminal device.