Abstract: Various endograft assemblies and methods for using the same. In at least one embodiment of an endograft assembly of the present disclosure, the endograft assembly comprises an endograft and a tube defining one or more tube openings coupled to said endograft. In another embodiment of an endograft assembly of the present disclosure, the endograft assembly comprises an endograft, a sponge sheath coupled to the endograft, and a reservoir bag coupled to the sponge sheath, said reservoir bag capable of receiving fluid from the sponge sheath.

Abstract: Anchored cardiovascular valves having a support member with at least one leaflet formed therein that is sized and configured to selectively restrict regurgitating blood through the valve, and at least one anchoring mechanism. In a preferred embodiment of the invention, the anchored valves have two anchoring mechanisms, i.e. proximal and distal anchoring mechanisms.

Abstract: An endovascular stent-graft is provided that is configured to assume a radially-compressed delivery state and a radially-expanded deployment state. The endovascular stent-graft comprises a flexible stent member; and a tubular fluid flow guide, which comprises a graft material, and which is attached to the stent member. The stent member includes a generally circumferential section that is shaped so as to define at least one fixation member having a sharp tip. When the stent-graft is in the radially-expanded deployment state, the fixation member protrudes radially outward. When the stent-graft is in the radially-compressed delivery state, at least a portion of the fixation member is convex as viewed from outside the stent-graft, such that the sharp tip points radially inward.

Abstract: A stent graft (10) for deployment into the aorta of a patient has a tubular body (12) with a proximal portion (14) of a selected diameter and a portion (16) of a reduced diameter less than the selected diameter distal of the proximal portion and a tapered portion (18) extending between the proximal portion and the portion of reduced diameter. Low profile side arms (26, 28, 30, 32) are provided in the portion of reduced diameter and/or the tapered portion. The side arms are for connection of an arm extension to an aortic branch vessel. A paraplegia prevention vent tube (34) is provided in fluid communication with the main lumen and open to external of the tubular body in the region defined by the portion of reduced diameter and the tapered portion.

Abstract: An arrangement for temporarily retaining a side arm (36) of a stent graft (30) in a selected position during loading thereof onto a deployment device, the side arm extending from an ostium (38) in the tubular body (32) and substantially helically around and along the tubular body to an open end (40). A first tie down wire (48) is stitched through the tubular body and through the side arm and then through the biocompatible graft material of the tubular body at the open end of the side arm. The stent graft can then be loaded into a sheath of a deployment device for the stent graft. There can be a second tie down wire (50) stitched through the biocompatible graft material of the tubular body and through the side arm and then through the biocompatible graft material of the tubular body at the ostium end of the side arm. The first and/or second tie down wires can be withdrawn after the stent graft is loaded into the sheath or left in place until delivery.

Abstract: The current invention comprises tubes that can be constrained and expanded by either axial or torsional strain. By torsionally displacing the tube in a direction counter to the biased helices and angularly displacing the lower angle helix to an angle equal to, but opposite, the starting angle, the tube is expanded diametrically with no significant change in length after expansion of the tube. These tubes find utility in medical and non medical applications.

Abstract: A stent may be inserted and placed in a lesion portion that is being stenosed or has been stenosed in a blood vessel or a lumen in the body to expand the lesion portion that is being stenosed or has been stenosed. Further, the stent and the artificial blood vessel layers are integrally formed with each other without floating between the stent and the artificial blood vessel layers. Accordingly, foods or other contents travelling through the pathway of a lumen in the body or blood in the vessel may be prevented from contacting the lesion portion, and the progress of the stenosis of the lesion portion may be prevented that may occur as the lesion portion grows toward the inside of the hollow cylindrical body of the stent.

Abstract: The stent graft (10) comprises a cylinder comprising a graft material in the form of a film and a stent that supports the cylinder. Further, the stent graft (10) is inserted within a region from the ascending aorta to the sinus of valsalva, and the stent graft comprises cylindrical body section (11) arranged in the ascending aorta and the sinus of valsalva section (12) arranged in the sinus of valsalva and having an inner diameter larger than that of the body section (11).

Abstract: Endovascular devices are provided. The endovascular devices include a conformable scaffold with one or more outpocketings. The outpocketing in the endovascular device creates a corresponding outpocketing of a vessel wall, thereby altering local fluid dynamics.

Abstract: The present invention provides a valved stent that can provide a valve function without blocking a branch blood vessel, and also can provide a valve function with minimum covering of blood vessel tissue in a stent indwelling section. Specifically, a cylindrical stent body 4 is provided. A leaflet 5 that can open/close a blood vessel 2 in a blood flow direction is provided. The leaflet 5 is composed of connective tissue and protrudes radially inward from the stent body 4. An inside and an outside of the stent body 4 radially communicate with each other. The stent does not block a branch blood vessel 8. An area of the blood vessel covered with the stent is reduced.

Abstract: A method of affixing a stent jacket to a stent, comprising aligning the stent jacket coaxially with the stent, placing a portion of the stent within a portion of the stent jacket, wherein a central axis of the stent is aligned with a central axis of the stent jacket, and affixing the stent jacket to the stent with a plurality of stitches, wherein the plurality of stitches form a plurality of consecutive loops that pass through one or more holes in the stent jacket and through an outer surface of the stent.

Abstract: The method for surface inclusions detection, enhancement of endothelial and osteoblast cells adhesion and proliferation and sterilization of electropolished and magnetoelectropolished Nitinol implantable medical device surfaces uses an aqueous solution of chemical compounds containing halogenous oxyanions as hypochlorite (ClO?) and hypobromite (BrO?) preferentially 6% sodium hypochlorite (NaClO).

Abstract: A stent graft (1) including a tubular wall (3) with at least one fenestration (40) including a peripheral (37) reinforcement around at least part of the fenestration. There can also be a tubular extension (15). The side arm includes a stent (19) and a cover (17) and extends from and is in fluid communication with the fenestration and the stent graft. The stent may be a self expanding stent. The ring and/or tubular extension provides better support and sealing for an extension arm. The fenestration (40) can be circular or if towards the ends of the stent graft may be in the form of a U-shape (50) with an open end.

Abstract: A segmented balloon expandable stent graft includes a graft material and a plurality of cylindrical stent elements coupled to the graft material. The plurality of cylindrical stent elements are plastically deformable when expanded from a radially compressed configuration to a radially expanded configuration. The plurality of cylindrical stent elements includes a first end stent element, a second end stent element, and a plurality of middle stent elements. The first and second end stent elements are independent of the plurality of middle stent elements. The first and second end stent elements are more resistant to radial expansion than the plurality of middle stent elements such that the plurality of middle stent elements plastically deform from the radially compressed configuration to the radially expanded configuration when inflated by a balloon prior the first and second end stent elements.

Abstract: Vascular scaffolds and methods of fabricating the same are disclosed for tissue engineering of vascular constructs. By combining electrospun matrices with cell sheet technologies, vascular constructs with more mature cell layers can be obtained for reconstruction of blood vessels, heart valves and the like. A engineered smooth muscle cell sheet, wrapped around an electrospun vascular scaffold, is able to provide a mature SMC layer that expresses strong cell-to-cell junction markers and contractile proteins. In addition, preconditioning of the cell sheet covered vascular scaffold maintained cell viability and infiltration into the scaffold.

Abstract: A stent graft has a tubular side arm which can be angled proximally and distally and from side to side. The wall of the stent graft in the vicinity of the side arm has a loose fold of the graft material and the side arm is fastened to the loose fold of graft material. The tubular side arm has an inner end and an outer end and is fastened into the loose fold of graft material by a circumferential fastening around the tubular side arm between the inner end and the outer end so that the tubular side arm extends partially within the tubular body of the stent graft and partially outside the tubular body of the stent graft. The loose fold of graft material can be formed by the graft material defining a recess in the wall of the stent graft. To enable movement or angulation proximally and distally and from side to side the loose fold of graft material is provided both proximally and distally of the tubular side arm and circumferentially to each side of the tubular side arm.

Abstract: A multi-component stent-graft system includes a first stent-graft, and second, third, and fourth branching stent-grafts. The first stent-graft is shaped so as to define, when in a radially-expanded state, proximal and distal superior first lateral openings facing in a first radial direction, and a distal inferior first lateral opening facing a second radial direction generally opposite the first radial direction.

Abstract: A stent assembly includes support rings each having interconnected circumferentially alternating inner prongs and outer prongs. The inner prongs define an inner diameter around a longitudinal axis. The outer prongs define an outer diameter greater than the inner diameter. A graft engages the support rings and follows a waving peripheral path. The graft may be a billowing graft. A second graft may surround the first graft such that tunnels are defined between the first graft and second graft. A method of making a stent assembly includes diametrically expanding the support rings onto a mandrel, engaging a graft with the support rings, and removing the support rings and graft from the mandrel permitting the stent assembly to contract to a neutral state.

Abstract: An endoprosthesis comprising a stent, a cover fully covering the stent wherein the cover has variable porosity in the radial direction; and an adhesion layer connecting the stent to the cover. Another aspect of the invention is a method of implanting an endoprosthesis which includes a stent, providing a cover with variable porosity in the radial direction, connecting the stent to the cover with an adhesion layer to form a covered stent, and implanting the covered stent within a body lumen of a patient.

Abstract: A medical device and method for closure of a puncture in a body lumen are disclosed. The device has an aggregate (10) of a support structure (20) and a substantially fluid tight patch member (30) attached thereto at an attachment unit (40). The aggregate has a first, temporary delivery shape, for delivery to an interior of said body lumen and to be subsequently subjected to a change of shape to a second shape, which is a tubular shape. When delivered in said body lumen, the patch member is arranged radially outside of said tubular support structure and arranged towards an inner tissue wall of the body lumen. The aggregate is the detached from a delivery device and said puncture is intraluminally closed in a leakage tight manner, advantageously supported by a physiological pressure of a body fluid in said body lumen. The device may biodegrade over time.

Abstract: A thoracic arch stent graft (1) has a tubular body of a biocompatible graft material (3) and at least one fenestration (13, 15) in the wall on one side thereof. A combination guide and tubular side arm assembly (20, 22) is mounted into the or each fenestration. The combination guide and tubular side arm assembly comprises a tubular portion (24) and a funnel portion (26) extending from a distal end of the tubular portion. The funnel portion has an angled open end. The tubular portion and the funnel portion are formed from a biocompatible graft material wall and have a lightweight space frame (38 40) formed from a resilient wire and supporting the graft material and defining the combination guide and tubular side arm assembly.

Abstract: A device and method for endovascular repair of a patient's aorta is disclosed. The device includes a frame component that has a balloon-expandable frame and a self-expanding frame secured to the balloon-expandable frame. The device also includes a valve element positioned at the proximal end of the frame component. The device may include another prosthetic component that may be secured to the frame component. The prosthetic component may include at least one conduit configured to receive a covered stent.

Abstract: An endoprosthesis for deployment within a body passage includes a framework and a metallic film, which can circumferentially surround the framework or be surrounded by the framework. The framework and metallic film can be attached without using a third material, e.g., without sewing. The framework can define a circumferential recess along at least a portion of its length and circumference. The recess accommodates at least a portion of the metallic film therein.

Abstract: A stent graft is provided which has two stent sections having different functions on, for example, a tubular graft. One stent section preferably comprises a plurality of circumferential reinforcing hoops and the other a Z-stent. The two sections are preferably separated by a spacer section and the tubular graft preferably increases in diameter from the Z-stent section to the hooped section. This enables the stent graft to be compressed radially so that it can be inserted in a catheter for later delivery to a body lumen.

Abstract: Vascular grafts for treating, reconstructing and replacing damaged or diseased cardiovascular vessels that are formed from decellularized extracellular matrix (ECM). The vascular grafts include outer or outer and inner coatings that provide structural reinforcement.

Abstract: Some embodiments relate in part to endovascular prostheses and methods of deploying same. Embodiments may be directed more specifically to stent grafts and methods of making and deploying same within the body of a patient. Stent embodiments may include tapered struts for an even distribution of strain. Stent embodiments may also include portions which are enlarged in a circumferential direction which may be configured to stabilize the stent in a constrained state.

Abstract: An endoprosthesis for deployment within a body passage includes an external tubular framework disposed about a tubular member, e.g., a metallic film having a thickness of about 50 ?m or less. The tubular member may be sandwiched between the external tubular framework and an internal tubular framework located internally of the external tubular framework and the tubular member. Whether or not the internal tubular framework is included, the endoprosthesis can be self-expanding. During deployment of the endoprosthesis using a deployment device, the external tubular framework prevents substantial frictional contact between the deployment device and the tubular member.

Abstract: A tubular graft device is provided comprising a tubular member and a fiber matrix of one or more polymers about a circumference of the tubular member. The matrix may be electrospun onto the tubular tissue. In one embodiment, the tubular tissue is from a vein, such as a harvested saphenous vein, useful as an arterial graft, for example and without limitation, in a coronary artery bypass procedure. Also provided is method of preparing a tubular graft and connecting the graft between a first body space and a second body space, such as the aorta and a location on an occluded coronary artery, distal to the occlusion.

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 vascular graft incorporating a stent into a portion of its length. While various materials may be used for the vascular graft, the graft is preferably an ePTFE graft. The stent is preferably a self-expanding stent, although it may alternatively be a balloon expandable stent. The vascular graft preferably has a continuous inner tubular liner that extends between the opposing ends of the graft and provides a continuous luminal surface for blood contact that is uninterrupted by seams or joints. The length portion of the graft that does not include the stent has a greater wall thickness than does the portion including the stent.

Abstract: A synthetic construct suitable for implantation into a biological organism that includes at least one polymer scaffold; wherein the at least one polymer scaffold includes at least one layer of polymer fibers that have been deposited by electrospinning; wherein the orientation of the fibers in the at least one polymer scaffold relative to one another is generally parallel, random, or both; and wherein the at least one polymer scaffold has been adapted to function as at least one of a substantially two-dimensional implantable structure and a substantially three-dimensional implantable tubular structure.

Abstract: Vascular grafts for treating, reconstructing and replacing damaged or diseased cardiovascular vessels that are formed from decellularized extracellular matrix (ECM). The vascular grafts include structural reinforcement means, such as a strand of wound biodegradable polymeric material disposed proximate the outer surface of the graft.

Abstract: Devices and methods for reducing or eliminating endoleaks by isolating feeder vessels from an aneurysm of a patient. In some cases, a tubular isolation sleeve may be deployed in a patient's aneurysm prior to deployment of an endograft such as a modular bifurcated endograft.

Abstract: An endoprosthesis, such as a stent, having anti-migration features. The endoprosthesis includes an expandable tubular framework including a plurality of strut rows and a plurality of connectors extending across interstices between adjacent strut rows and interconnecting adjacent strut rows. The strut rows have an outer diameter in an expanded state and the connectors extend radially outward beyond the outer diameter of the strut rows in the expanded state. The connectors are configured to engage a wall of a body lumen in the expanded state to inhibit migration of the endoprosthesis in the body lumen. The endoprosthesis may include a polymeric cover covering the strut rows and spanning the interstices between adjacent strut rows, while a space between the connectors and the strut rows to which the connectors are interconnected with is devoid of the polymeric cover to permit tissue ingrowth around the connectors.

Abstract: A method of deploying an eversible branch stent-graft includes deploying the eversible branch stent-graft into a main vessel such that a collateral opening in a main stent-graft of the eversible branch stent-graft is aligned with an ostium of a branch vessel emanating from the main vessel. A branch stent ring suture threaded though outer exposed crowns of an outer stent ring of the branch stent-graft is grasped and pulled through the collateral opening to evert the branch stent-graft into the branch vessel as a branch anchor suture is removed to release a protruding end of a branch stent-graft from a proximal end of the main stent-graft.

Abstract: A stentless support structure capable of being at least partly assembled in situ. The support structure comprises a braided tube that is very flexible and, when elongated, becomes very long and very small in diameter, thereby being capable of placement within a small diameter catheter. The support structure is preferably constructed of one or more thin strands of a super-elastic or shape memory material such as Nitinol. When released from the catheter, the support structure folds itself into a longitudinally compact configuration. The support structure thus gains significant strength as the number of folds increase. This radial strength obviates the need for a support stent. The support structure may include attachment points for a prosthetic valve.

Abstract: A medical device consists of a stent having a first surface and a second surface parallel to the first surface; a single expanded polytetrafluoroethylene (ePTFE) layer contacting the first surface of the stent; and an elastomeric layer applied to at least one surface of the stent. In at least one embodiment, the elastomeric layer is silicone. In at least one embodiment, the medical device is manufactured by positioning the ePTFE layer such that a first surface of the ePTFE layer contacts a first surface of the stent to form a stent-ePTFE assembly; and applying an elastomeric solution to the first surface of the ePTFE layer and at least one surface of the stent.

Abstract: Methods of manufacturing polymeric intraluminal prostheses include annealing the polymeric material to selectively modify the crystallinity thereof. Annealing may be utilized to selectively modify various properties of the polymeric material of an intraluminal prosthesis, including: selectively increasing the modulus of the polymeric material; selectively increasing the hoop strength of the intraluminal prosthesis; selectively modifying the elution rate (increase or decrease) of a pharmacological agent subsequently disposed on or within the annealed polymeric material; selectively increasing/decreasing stress in the intraluminal prosthesis; and selectively modifying the polymeric material such that it erodes at a different rate.

Abstract: The present invention relates to covered endoprosthetic devices. Covered endoprosthetic devices comprise an endoprosthesis and a sheath. The sheath comprises a central portion and outer portions, wherein the central portion preferentially restricts or causes a restriction of blood flow. Blood flow can be reduced by the central portion of the sheath by varying the permeability of the sheath or by having projections on the sheath that slow blood flow. Permeability may be provided by perforations or holes in the material of the sheath or by varying the polymer structure that makes up the sheath itself. The outer portions of the sheath do not substantially reduce blood flow. Methods of using sheath-covered endoprosthetic devices of the invention to treat aneurysms, especially aneurysms in proximity to small perforator vessels or arteries, are also encompassed.

Abstract: A circumferentially constraining suture for an endovascular prosthesis having a tubular body and a plurality of stents coupled to the tubular body includes a first thread coupled at a first end to one of the stents and a first thread loop disposed opposite the first end. The first thread extends only partially around a circumference of the tubular body in a radially expanded configuration. A second thread having a second thread loop is interlocked with the first thread loop and extends from the first thread loop around a remainder of the circumference of the tubular body. Pulling the second thread causes the first thread to circumferentially constrain the tubular body to a reduced diameter configuration. A trigger wire inserted through the first thread loop retains the first thread such that the tubular body is in the reduced diameter configuration after removal of the second thread.

Abstract: This invention relates generally to an endoluminal prosthesis, and more particularly, to a stent graft assembly and method for treating branched vessels. The assembly includes a first pr sthesis, such as an iliac branch device (IBD), comprising a tubular main body, a first leg extending from a distal end of the main body and at least one fenestration formed in the main body. An internal tubular side branch extends proximally from the fenestration into the lumen of the main body, resulting in an iliac branch device having an overall reduced proximal length. The assembly further includes a second prosthesis, or a bridging limb, having a distal end with a scalloped fenestration formed therein to accommodate sealing with the proximal end of the iliac branch device without interfering with the internal branch. A connecting stent graft adapted for placement in the internal iliac artery may be sealingly connected to the internal branch.

Abstract: A catheter assembly for endoluminal delivery of a device to a treatment site utilizing a single motion deployment for opening and removal of a flexible protective sleeve or constraining sleeve.

Abstract: A branched stent graft comprises a main body portion and a branch portion. Each of the main body portion and the branch portion includes a stent and a tubular graft. The stent of the main body portion includes a plurality of stent segments, at least one of which is a varying-height stent segment (102). The stent of the branch portion includes one or more stent segments, at least one of which is a varying-height stent segment (103). The distance between the proximal-most stent segment of the branch portion and the main body portion is in the range of 2-8 mm. A positioning ring (105) may be used at a side opening which connects the branch portion and the main body portion, and the positioning ring (105) can be sutured inside the graft of the main body, between the graft of the main body and the graft of the branch, or outside the graft of the branch.

Abstract: An endoprosthesis has an expanded state and a contracted state, the endoprosthesis includes a stent having an inner surface defining a lumen, having an outer surface, and defining a plurality of apertures through the outer surface, wherein the apertures are arranged in a micropattern; and a coating (e.g., polymeric coating) attached to the outer surface of the stent. The coating includes a base and a tissue engagement portion including a second surface facing outwardly from the stent, the tissue engagement portion including a structure that defines a plurality of holes extending inwardly from the second surface toward the base. The holes are arranged in a micropattern. When the endoprosthesis is expanded to the expanded state in a lumen defined by a vessel wall, the structure applies a force that may reduce stent migration by creating an interlock between the vessel wall and the endoprosthesis.

Abstract: This invention relates generally to an endoluminal prosthesis, and more particularly, to a stent graft assembly and method for treating branched vessels. The assembly comprises a first prosthesis having an overall shortened length comprising a main body formed of biocompatible graft material having a tapered proximal end. A bifurcated portion extends distally from the main body. The bifurcated portion comprises a first tubular portion defining a first lumen and a second tubular portion defining a second lumen. The assembly further comprises a second prosthesis having a tubular body of biocompatible graft material with a flared distal end portion. The flared distal end portion of the second prosthesis is configured to sealingly engage with the tapered main body of the first prosthesis.

Abstract: Articles comprising an expanded polytetrafluoroethylene membrane having serpentine fibrils and having a discontinuous coating of a fluoropolymer thereon are provided. The fluoropolymer may be located at least partially in the pores of the expanded fluoropolymer membrane. In exemplary embodiments, the fluoropolymer is fluorinated ethylene propylene. The application of a tensile force at least partially straightens the serpentine fibrils, thereby elongating the article. The expanded polytetrafluoroethylene membrane may include a microstructure of substantially only fibrils. The articles can be elongated to a predetermined point at which further elongation is inhibited by a dramatic increase in stiffness. In one embodiment, the articles are used to form a covered stent device that requires little force to distend in the radial direction to a first diameter but is highly resistant to further distension to a second diameter (stop point).

Abstract: A lumbar occluding device or patch is disclosed for reducing Type II endoleaks in connection with endovascular aneurysm repair (EVAR) of aortic aneurisms. The lumbar occluding patch can be applied to a vessel wall and, more particularly, the posterior wall of the aortic artery in the location of the abdominal aneurysm to block or occlude an array of lumbar artery ostia concurrent with or following a stent graft deployment in an EVAR procedure.

Abstract: A multi-component endovascular stent-graft system (10) includes a body portion (16), which includes a plurality of stent-grafts (20), which include: (a) respective stent members (22), which are shaped, when the stent-grafts (20) are in respective radially-expanded states, so as to define respective tubes, each of which is circumferentially complete at at least one longitudinal location therealong; and (b) respective graft members (24), which circumscribe respective circumferential arcs (40) of the respective stent members (22). The circumferential arcs (40) have respective extents that are less than entire circumferences of the respective stent members (22) at least partially along respective axial lengths of the stent members (22).

Abstract: Some embodiments of the present disclosure are directed to endoluminal prostheses having one or more reinforced fenestrations therein. The one or more reinforced fenestrations can have improved sealing capabilities with respect to branch grafts deployed within the fenestrations, improved tear resistance and expandability, and improved pull-out resistance for branch grafts. In some embodiments, the endoluminal prosthesis can have a main graft body defining a flow lumen therethrough, a first opening passing through a wall of the main graft body, and a first support member supported by the main graft body and overlapping an edge of the first opening, the first support member being configured to at least increase the tear resistance of the main graft body adjacent to the first opening. The support member can be stitched or otherwise attached to the main graft adjacent to the fenestration.

Abstract: A stent graft (1) including a tubular wall (3) with at least one fenestration (40) including a peripheral (37) reinforcement around at least part of the fenestration. There can also be a tubular extension (15). The side arm includes a stent (19) and a cover (17) and extends from and is in fluid communication with the fenestration and the stent graft. The stent may be a self expanding stent. The ring and/or tubular extension provides better support and sealing for an extension arm. The fenestration (40) can be circular or if towards the ends of the stent graft may be in the form of a U-shape (50) with an open end.