Abstract: A device and method for repair of a patient's aorta is disclosed. The device includes a first component including an outer diameter equal to a first diameter, a second component attached to a distal end of the first component, and a plurality of third components positioned in a chamber defined in the second component. The second component includes a proximal surface extending outwardly from the distal end of the first component, and a plurality of openings defined in the proximal surface. Each third component includes a passageway extending inwardly from an opening of the plurality of openings defined in the proximal surface. Each passageway is sized to receive a tubular conduit, and the proximal surface has an outer edge that defines a second diameter greater than the first diameter.

Abstract: Methods of declotting vascular access technologies, such as vascular access assemblies that facilitate hemodialysis, are provided. The methods can include disposing a catheter within a patient to access a vascular access assembly within the heart of the patient. The catheter can be coupled to the vascular access assembly such that a clot can be evacuated from within the vascular access assembly via the catheter.

Abstract: A prosthesis implanting system includes a delivery sheath for receiving the prosthesis and delivering it to the treatment site and an alignment device on the sheath visible to a user for indicating a rotational and an axial position of the sheath with respect to the treatment site. The alignment device is part of a delivery assembly slidably disposed in a handle.

Abstract: A device for treating disease along a main vessel and at least one branch vessel extending from the main vessel includes a branch member for deployment in the branch vessel, the branch member having a branch lumen; and a main body for deployment in the main vessel. The main body has a generally tubular wall extending generally longitudinally between opposite first and second ends. The wall has an internal surface defining a main lumen and an opposite outer surface. The wall has a recessed portion that is recessed relative to the outer surface of the wall and positioned between the first and second ends of the main body. The main body has an opening formed in the recessed portion of the wall for receiving the branch member therethrough such that the branch lumen is in fluid communication with the main lumen.

Abstract: An endograft is provided for a blood vessel having a branch extending from said blood vessel, including a body having a wall defining a lumen and an exterior surface. The endograft body includes a first portion defining or being made to define a non-circular cross-sectional dimension, and a second portion defining a circular cross-sectional dimension. Modular systems including the endograft and methods for creating endografts according to the disclosure are described also.

Abstract: An endovascular delivery system includes a bifurcated and inflatable prosthesis including a main tubular body having an open end and opposed ipsilateral and contralateral legs defining a graft wall therein between. A tether is disposed securably disposed to the contralateral leg, and the contralateral leg is releasably restrained towards the ipsilateral leg tether to prevent undesirable movement of the contralateral leg. A release wire within the endovascular delivery system releasably retains the tether near the ipsilateral leg.

Abstract: The present invention provides a modular stent-graft system. In one embodiment, a prosthesis comprises a first tubular graft comprising a layer of graft material, one lumen extending therein, and a first fenestration extending through the layer of graft material. A layer of fenestration covering material attaches to the layer of graft material. The layer of fenestration covering material is disposed in the lumen of the first tubular graft and partitions the first fenestration from the lumen of the first tubular graft. A first non-stented opening is disposed proximal to the first fenestration and communicates with the first fenestration between the layer of graft material and the fenestration covering material. In use, a proximal end of a second tubular graft sealably engages the first non-stented opening, and the second tubular graft further extends through the first fenestration and into a branch vessel.

Abstract: A dual lumen catheter may be provided with one or more stents in a stent-deployment lumen and a wire guide disposed through a wire guide lumen. The wire guide may be directed to a target site in a patient body such as a biliary stricture. The catheter may be directed along the wire guide until it is in or adjacent the target site. A distalmost stent may be advanced out a distal side-facing aperture of the stent-deployment lumen into the target site by a pusher member that advances the stent or that holds the stent in place while the catheter is proximally withdrawn from around the stent. With the wire guide remaining substantially in place, the stent-deployment lumen can be reoriented and the steps repeated to place a second (and, if desired, subsequent) stent(s) next to—and generally parallel with—the first stent.

Abstract: A delivery system assembly includes an outer tube, an inner member, extending within a lumen of the outer tube, and a deflectable shaft, extending within the outer tube lumen and around the inner member; the tube and inner member are longitudinally moveable with respect to the shaft, and a distal end of the inner member is located distal to the shaft within the tube lumen. A medical device can be loaded into the tube lumen, along a distal-most portion of the tube, and contained between the inner member and a distal opening of the tube lumen. Deflecting the shaft orients the distal-most portion for navigation of the assembly, and, when the distal end of the inner member is engaged within the tube lumen, distal movement of the tube, with respect to the shaft, causes similar distal movement of the inner member and the loaded medical device toward an implant site.

Abstract: Embodiments provide methods and systems for treating aneurysms using filling structures filled with a curable medium. An embodiment of a method comprises positioning at least one double-walled filling structure across the aneurysm and filling the structure(s) with a filling medium so that an outer wall conforms to the inside of the aneurysm and an inner wall forms a generally tubular lumen to provide for blood flow. The lumen is supported with a balloon or other expandable device while and/or after filling. The pressure within the structure and/or in the space between an external wall of the structure and the aneurysm wall is monitored and a flow of the medium into the structure is controlled responsive to the pressure. The pressure can also be used to determine a filling endpoint. The medium is hardened while the lumen remains supported by the balloon. The balloon is then removed after the medium hardens.

Abstract: Aneurysms are treated by filling at least one double-walled filling structure with a curable medium within the aneurysm. The filling structures may be delivered over balloon deployment mechanisms in order to shape and open tubular lumens therethrough. Scaffolds are placed into the tubular lumens in order to help maintain the shape, anchor the filling structures in place, and provide improved blood flow transition into and out of the tubular lumens.

Abstract: Disclosed is an intraluminal gastrointestinal (GI) device that is placed at the time of surgery to protect a freshly constructed GI anastomosis, GI staple-line, or the like. For the esophagus and stomach, the device covers the esophagus, stomach, and anastomosis/staple-line. For the pancreas or biliary duct, the device covers the biliary duct, pancreatic duct, and small bowel. For the colon and rectum, the device is a self expanding protective barrier that covers the anal canal, the anus, and the colon or rectum, approximately 18 cm proximal to the anus. These devices provide a waterproof barrier between the gastrointestinal content and the mucosa of the GI tract and the newly constructed anastomosis. Additionally, the design of the device is made to prevent migration within the gastrointestinal tract and facilitate removal of the device.

Abstract: A catheter assembly may include a main balloon arranged to reside within the main vessel, and a branch balloon configured to extend from the main vessel into the branch vessel. A stent may be situated around the main balloon and may include a branch aperture at a location between proximal and distal open ends of the stent. The branch balloon may extend from within the stent, through the branch aperture, and into the branch vessel. The branch balloon, when inflated, may extend into the branch vessel. The main balloon, when inflated, may also expand the stent within the main vessel. In some arrangements, the branch balloon, when inflated, can function as an anchor within the branch vessel that resists radial and axial movement of the stent relative to the branch vessel and main vessel during expansion of the stent by the main balloon.

Abstract: The invention provides method of fabricating a scaffold comprising a fluidic network, including the steps of: (a) generating an initial vascular layer for enclosing the chamber and providing fluid to the cells, the initial vascular layer having a network of channels for fluid; (b) translating the initial vascular layer into a model for fluid dynamics analysis; (c) analyzing the initial vascular layer based on desired parameters selected from the group consisting of a characteristic of a specific fluid, an input pressure, an output pressure, an overall flow rate and combinations thereof to determine sheer stress and velocity within the network of channels; (d) measuring the sheer stress and the velocity and comparing the obtained values to predetermined values; (e) determining if either of the shear stress or the velocity are greater than or less than the predetermined values, and (f) optionally modifying the initial vascular layer and repeating steps (b)-(e).

Abstract: Scaffold-supported metal or pseudometallic film covers suitable for use as medical devices are disclosed together with methods of fabricating the devices. Methods for making the medical devices consist of either providing or forming a scaffold, then depositing a metallic or pseudometallic film cover onto the scaffold in such a manner as to form an integral, substantially monolithic junction between the deposited cover material and the scaffold.

Abstract: A catheter assembly configured for treatment of a vessel bifurcation. The catheter assembly includes a catheter shaft and first and second balloons. The second balloon extends radially outward relative to the first balloon when expanded. A valve arrangement controls expansion of the second balloon. Portions of the valve arrangement can be positioned at proximal and distal end portions of the catheter shaft. Typically, the first balloon is expanded followed by expansion of the second balloon. A stent having a lateral branch opening is operatively mounted to the first balloon. The second balloon is configured to extend through the lateral branch opening when the second balloon is expanded.

Abstract: Systems and methods for producing scaffolds are disclosed. The system includes a polymer solution and a non-solvent, which are sprayed into receiving portions of support elements. After scaffolds are formed on the support elements, the support elements permit elongation of the scaffolds. Composites formed from a plurality of scaffolds are also disclosed.

Abstract: Various embodiments of methods and apparatus for treating defective heart valve are disclosed herein. In one exemplary embodiment, a transcatheter heart valve is disclosed that includes an expandable shape memory stent and a valve member supported by the stent. A plurality of micro-anchors can be disposed along an outer surface of the stent for engaging native tissue. The transcatheter heart valve can be configured to be advanced into a dilated valve annulus via a balloon catheter. The balloon can be inflated to expand the transcatheter heart valve from a collapsed diameter to an over-expanded diameter such that the micro-anchors engage tissue along the surrounding valve annulus. After engaging the tissue, the balloon can be deflated and the shape memory stent can retract or recoil toward its predetermined recoil diameter. As the stent recoils, the surrounding tissue is pulled inward by the stent such that the diameter of the valve annulus is reduced.

Abstract: An endoprosthesis (e.g., a sleeve) can be used to deliver therapeutic agents to lesion sites. In some embodiments, one or more sleeves can be delivered to one or more body lumen sites in relatively few intervention procedures. The sleeve can be used to deliver therapeutic agents to a de novo site or the site of a previously deployed stent, or a stent may be co-administered along with one or more sleeves.

Abstract: A prosthetic device for creating a vascular bypass from an arterial vessel has at least one prosthetic tube joined to an orifice of a flexible collar. The prosthetic tube extends from an outer face of the collar. The collar has an inner face surface for attachment to the arterial vessel. The collar has a connection zone has an annular cavity extending around and away from the orifice. The annular cavity is suitable for receiving an injected glue or bioabsorable haemostatic product so as to attach to the arterial vessel.

Abstract: A method of forming a stent includes the steps of forming an elongated composite member or plurality of elongated composite members into a stent pattern having struts interconnected by crowns, the composite member including an outer member and a core member. Openings are formed through the outer member of the composite member. The composite member is processed to remove the core member from at least a plurality of the struts of the stent without adversely affecting the outer member and such that the core member is not removed from at least a plurality of the crowns of the stent, thereby leaving the outer member with a lumen in at least a plurality of the struts and the outer member with the core member in at least a plurality of the crowns. The lumens may then be filled with a biologically or pharmacologically active substance.

Abstract: Methods for treatment of aneurysms using a sequential manifold console to deploy multiple filling structures are provided herein. In one aspect, aneurysms are treated by simultaneously filling two double-walled filling structure using a sequential manifold console to guide a user in the steps to be followed in the procedure and to reliably achieve a consistent and durable aneurysmal treatment using a curable medium. The structures may be delivered over balloon deployment mechanisms in order to shape and open tubular lumens therethrough. Pairs of filling structures delivered to the aneurysm from different access openings of a patient can be simultaneously prepared and pressurized from a single treatment console when treating abdominal aortic aneurysms using the described systems and methods.

Abstract: A collapsible stent graft for aortic aneurysms includes a collapsible inner tubular member (26) and an outer layer (24) fused or adhered thereto such as to provide a spiral inflatable member (22) therebetween. The stent graft is inserted into an artery in the collapsed state and then expanded into position by introducing a liquid into the inflatable member and sealing the member. The graft is held in place by an expandable stent (40).

Abstract: A method for making an encapsulated stent includes providing a first seamless unsintered ePTFE tube, providing a second seamless sintered ePTFE tube, positioning a self-expanding stent between the first and second ePTFE tubes to form an assembly, disposing an ePTFE interlayer member between the first and second ePTFE tubes, and joining the first ePTFE tube to the second ePTFE tube through openings in a wall of the stent by applying first pressure, and then heat, to the assembly.

Abstract: The present invention consists of an implantable structural element for in vivo delivery of bioactive active agents to a situs in a body. The implantable structural element may be configured as an implantable prosthesis, such as an endoluminal stent, cardiac valve, osteal implant or the like, which serves a dual function of being prosthetic and a carrier for a bioactive agent. Alternatively, the implantable structural element may simply be an implantable article that serves the single function of acting as a time-release carrier for the bioactive agent.

Abstract: A stenting system for insertion into the lumen of a body duct or vessel for delivering a therapeutic agent to a treatment site on the duct or vessel. The stenting system includes an a tubular stent member having a lumen there through to allow the passage of material, an outer membrane attached to the stent at least a portion of which is porous to the therapeutic agent to allow the agent to pass to the treatment site, an inner membrane attached to the stent which is nonporous to the therapeutic agent to prevent the agent from entering the lumen of the stent, and a chamber located between the inner and outer membranes for holding the therapeutic agent. The therapeutic agent in the chamber may diffuse through the porous portion of the membrane and be deposited directly on the body site.

Abstract: A stent is adapted to be implanted in a duct of a human body to maintain an open lumen at the implant site, and to allow viewing body tissue and fluids by magnetic resonance imaging (MRI) energy applied external to the body. The stent constitutes a metal scaffold. An electrical circuit resonant at the resonance frequency of the MRI energy is fabricated integral with the scaffold structure of the stent to promote viewing body properties within the lumen of the stent.

Abstract: A method for making an encapsulated stent includes providing a first seamless unsintered ePTFE tube, providing a second seamless sintered ePTFE tube, positioning a self-expanding stent between the first and second ePTFE tubes to form an assembly, and joining the first ePTFE tube to the second ePTFE tube through openings in a wall of the stent by applying first pressure, and then heat, to the assembly.

Abstract: A stent is adapted to be implanted in a duct of a human body to maintain an open lumen at the implant site, and to allow viewing body tissue and fluids by magnetic resonance imaging (MRI) energy applied external to the body. The stent constitutes a metal scaffold. An electrical circuit resonant at the resonance frequency of the MRI energy is fabricated integral with the scaffold structure of the stent to promote viewing body properties within the lumen of the stent.

Abstract: A self-sealing vascular graft with kink resistance is described. The vascular graft includes a substrate that can be a PTFE, having a self-sealing region that may include several layers of material. The central section of the vascular graft may be constructed differently from surrounding self-sealing regions, in order to provide kink resistance following the clamping of the graft. Also described is a graft with a flared cuff attached to one or both ends, the attachment or transition region including reinforcement beading.

Abstract: Scaffold-supported metal or pseudometallic film covers suitable for use as medical devices are disclosed together with methods of fabricating the devices. Methods for making the medical devices consist of either providing or forming a scaffold, then depositing a metallic or pseudometallic film cover onto the scaffold in such a manner as to form an integral, substantially monolithic junction between the deposited cover material and the scaffold.

Abstract: In one aspect, the invention provides methods for forming a target tissue substitute. The methods of the invention comprise the following steps: (a) providing a scaffold comprising one or more layers of one or more arrays of microfibers, wherein one or more of the arrays of microfibers is designed to mimic the configuration of one or more structural elements in a target tissue; and (b) culturing cells on the scaffold to form a target tissue substitute. In another aspect, the invention provides implantable medical devices. The implantable medical devices of the invention comprise a scaffold comprising one or more layers of one or more arrays of microfibers, wherein one or more of the arrays of microfibers is arranged to mimic the configuration of one or more structural elements in a target tissue. Typically, cells are cultured on the scaffold to form a target tissue substitute.

Abstract: There is disclosed medical devices, such as stents, guidewires and embolic filters, comprising a binary alloy of titanium and one binary element selected from platinum, palladium, rhodium, and gold. There is also disclosed a radiopaque marker comprising the disclosed binary alloy, as well as medical devices having the radiopaque marker attached thereto. Methods of attaching the radiopaque marker to the medical devices, such as by welding, are also disclosure also disclosed.

Abstract: An arteriovenous graft system is described. The arteriovenous graft system includes an arteriovenous graft that is well suited for use during hemodialysis. In order to minimize or prevent arterial steal, at least one valve device is positioned at the arterial end of the arteriovenous graft. In one embodiment, a subcutaneous arteriovenous graft system is described. The system includes an arteriovenous graft having an arterial end and an opposite venous end with a first valve device positioned at the arterial end of the arteriovenous graft and a second valve device positioned at the venous end of the arteriovenous graft. The system also includes an actuator having an accumulator. The actuator is in communication with both the first valve device and the second valve device and is configured to cause each valve device to open or close simultaneously. The accumulator assists in maintaining a generally constant pressure when the actuator causes each valve device to close.

Abstract: A multilayer braided luminal self-expanding stent (4) for an anatomical conduit (8) comprising a outer braided peripheral stent (10) which is permanently linked to an inner, braided, hemodynamic flow deflector (2) by at least a pair of filaments (12) that make part of a common braided structure.

Abstract: A vascular graft device includes a semipermeable inner wall surrounding a passage. A nonpermeable outer wall surrounds the inner wall. A biological agent is disposed between the inner and outer walls for release through the inner wall.

Abstract: A stent is adapted to be implanted in a duct of a human body to maintain an open lumen at the implant site, and to allow viewing body tissue and fluids by magnetic resonance imaging (MRI) energy applied external to the body. The stent constitutes a metal scaffold. An electrical circuit resonant at the resonance frequency of the MRI energy is fabricated integral with the scaffold structure of the stent to promote viewing body properties within the lumen of the stent.

Abstract: A prosthesis for large blood vessels includes a main conduit. At least one tract of the main conduit is subdivided into a plurality of smaller conduits located parallel to one another.

Abstract: An endoluminal device for affixation to a wall of a body lumen having a neck region defined by a relatively narrow width and a shoulder region that diverges from the neck region to a relatively wider width. The device comprises a shoulder portion, which may be part of a bulbous portion, having a diameter profile that conforms to the shoulder region, and, in some embodiments, a plurality of affixation members in an area of the device that typically extends from a distal end of the device through the shoulder portion. In one embodiment, the device comprises an endograft for repair of an aneurysm, such as an abdominal aortic aneurysm (AAA). Methods of using the endograft to inhibit continued diametric expansion of the aneurysm and to inhibit endoleak formation and migration of the endograft are also described.

Abstract: A grafted network including one or more graft segments for use in coronary bypass procedures and which are configured to operably transport bypass blood flow from a singular supply location to one or more delivery locations, and which is provided in combination with one or more multiple channel blood flow connectors for directing such bypass blood flow in the grafted network to one or more vascular members requiring restorative blood flow thereto. The grafted network also preferably includes one or more devices for operably maintaining the grafted network under relatively high internal fluid pressure so as to continuously supply selective vascular members with adequate bypass blood flow.

Abstract: A grafted network including one or more graft segments for use in coronary bypass procedures and which are configured to operably transport bypass blood flow from a singular supply location to one or more delivery locations in the grafted network is provided in combination with one or more multiple channel blood flow connectors for directing such bypass blood flow in the grafted network to one or more vascular members requiring restorative blood flow thereto. The grafted network also preferably includes one or more devices for operably maintaining the grafted network under relatively high internal fluid pressure so as to continuously supply selective vascular members with adequate bypass blood flow.

Abstract: The present invention is a system, apparatus, and method for treating, repairing, and/or replacing an aneurysm, preferably an aortic aneurysm, the most preferably, an abdominal aortic aneurysm. The systems, devices, and methods of the present invention include a first prosthesis or stent gasket, and at least one second prosthesis for bypassing the aneurysm, and at least one third prosthesis for establishing a fluid flow channel from the abdominal aorta into another artery, such as a renal artery.

Abstract: A stenting system for insertion into the lumen of a body duct or vessel for delivering a therapeutic agent to a treatment site on the duct or vessel. The stenting system includes an a tubular stent member having a lumen there through to allow the passage of material, an outer membrane attached to the stent at least a portion of which is porous to the therapeutic agent to allow the agent to pass to the treatment site, an inner membrane attached to the stent which is nonporous to the therapeutic agent to prevent the agent from entering the lumen of the stent, and a chamber located between the inner and outer membranes for holding the therapeutic agent. The therapeutic agent in the chamber may diffuse through the porous portion of the membrane and be deposited directly on the body site.

Abstract: The present invention provides an implantable graft, including a primary tubular body having a first outer wall surface and a first inner wall surface defining a primary blood contacting lumen, and a secondary tubular body having a second outer wall surface and a second inner wall surface. The secondary tubular body is located about the primary tubular body to form a space therebetween. The primary and secondary tubular bodies are joined by at least one rib.

Abstract: The present invention provides modular bifurcated intraluminal tubular prostheses, particularly stents and stent-grafts, for the treatment of disease conditions, particularly aneurysms. Modular sections of the prostheses, or “prosthetic modules,” may be selectively assembled to form a prosthesis having characteristics which are tailored to the specific requirements of the patient, including branch angle and branch lumen sizes which match the patients vascular geometry. A Y-connector prosthetic module structure provides support and separation for each of the adjacent branching lumens. Radiopaque markers on the prostheses promote alignment between prosthetic modules and with the body lumen system.

Abstract: A system and method for treating and repairing complex anatomy characterized by a plurality of vessel portions oriented at various angles relative to each other. The system including a graft device that is capable of being assembled in situ and has associated therewith a method that avoids the cessation of blood flow to vital organs.

Abstract: An implant for use in direct left ventricle to coronary vessel revascularization is disclosed. The implant includes a sleeve sized to pass through a heart wall. The sleeve is sufficiently rigid to remain open during contraction of the heart. The implant also includes a plurality of conduits at least partially mounted in the sleeve.

Abstract: A stent is adapted to be implanted in a duct of a human body to maintain an open lumen at the implant site, and to allow viewing body tissue and fluids by magnetic resonance imaging (MRI) energy applied external to the body. The stent constitutes a metal scaffold. An electrical circuit resonant at the resonance frequency of the MRI energy is fabricated integral with the scaffold structure of the stent to promote viewing body properties within the lumen of the stent.

Abstract: The present invention provides an implantable graft, including a primary tubular body having a first outer wall surface and a first inner wall surface defining a primary blood contacting lumen, and a secondary tubular body having a second outer wall surface and a second inner wall surface. The secondary tubular body is located about the primary tubular body to form a space therebetween. The primary and secondary tubular bodies are joined by at least one rib.

Abstract: Disclosed is a tubular endoluminal vascular prosthesis, useful in treating, for example, an abdominal aortic aneurysm. The prosthesis comprises a self-expandable wire support structure having a tubular main body support and first and second branch supports. The support structure may include sliding links to permit flexibility while maintaining patency of the central lumen. The branch supports may articulate with the main body to permit the branches to pivot laterally from the axis of the main body throughout a substantial range of motion. Exoskeleton components or barbs may be provided to resist migration and endoleaks.