Abstract: At least some embodiments of the disclosure may advantageously limit bleeding and the occurrence of blood leaks after heart pump implantation. In some embodiments, a base may be provided that includes a flexible layer mechanically coupled with a conduit. The flexible layer may be coupled with the proximal end of the conduit. The conduit may be configured to receive a cannula of the heart pump therethrough. The outer surface of the conduit may be configured to engage a surface of the heart formed after coring the heart. The conduit may be metal and may have a flared and/or beveled distal end. The conduit may be a flexible material. A distal flexible layer may be provided at a distal end of the conduit that is configured to engage with an inner surface of the heart.

Abstract: A system for providing instillation fluid to a deep abdominal wound includes an instillation module and a connection structure. The instillation module defines a first surface and a second, abdominal contents-facing surface. The instillation module includes a distribution hub configured to receive instillation fluid from an instillation fluid source. The connection structure includes a first surface, a second, abdominal contents-facing surface; and a flow path extending between the first surface and the second surface. The flow path includes an inlet configured to receive an instillation fluid conduit engaged with the instillation fluid source and an outlet in fluid communication with the instillation module. The flow path defines an axis extending between the inlet and the outlet. The flow path is configured to compress in a direction defined by the axis.

Abstract: Devices and methods for treating a sinus venosus atrial septal defect. A treatment device may have a tubular shape and may be configured to be arranged to provide a conduit between an upper right pulmonary vein (PV) and a left atrium (LA). The device may have a proximal portion comprising a flexible mesh configured to anchor within the LA, a distal portion comprising a flexible mesh configured to anchor within the target PV, and a central portion having a plurality of elongate parallel bars. A method for treating a sinus venosus atrial septal defect may include percutaneously advancing the device through the femoral vein and inferior vena cava (IVC), and into the right atrium (RA). The method may include creating a trans-septal opening, passing the device through the opening into the LA, and toward the upper right PV to treat the defect.

Abstract: Tissue anchors comprise a woven filament braid body having an elongated tubular configuration and a foreshortened configuration where proximal and distal ends of the body expand radially into double-walled flange structures while leaving a cylindrical saddle region therebetween. The tissue anchors are deployed through penetrations between adjacent tissue layers, where the flanges engage the outer surfaces of the tissue layers and the saddle region resides within the tissue penetrations.

Abstract: Tissue anchors comprise a woven filament braid body having an elongated tubular configuration and a foreshortened configuration where proximal and distal ends of the body expand radially into double-walled flange structures while leaving a cylindrical saddle region therebetween. The tissue anchors are deployed through penetrations between adjacent tissue layers, where the flanges engage the outer surfaces of the tissue layers and the saddle region resides within the tissue penetrations.

Abstract: At least some embodiments of the disclosure may advantageously limit bleeding and the occurrence of blood leaks after heart pump implantation. In some embodiments, a base may be provided that includes a flexible layer mechanically coupled with a conduit. The flexible layer may be coupled with the proximal end of the conduit. The conduit may be configured to receive a cannula of the heart pump therethrough. The outer surface of the conduit may be configured to engage a surface of the heart formed after coring the heart. The conduit may be metal and may have a flared and/or beveled distal end. The conduit may be a flexible material. A distal flexible layer may be provided at a distal end of the conduit that is configured to engage with an inner surface of the heart.

Abstract: A coated coronary stent, comprising a stainless steel sent framework coated with a primer layer of Parylene C, and a rapamycin-polymer coating having substantially uniform thickness disposed on the stent framework, wherein the rapamycin-polymer coating comprises polybutyl methacrylate (PBMA), polyethylene-co-vinyl acetate (PEVA) and rapamycin, wherein substantially all of the rapamycin in the coating is in amorphous form and substantially uniformly dispersed within the rapamycin-polymer coating.

Abstract: A method of making a contoured internal limb including providing a flattened tubular segment of graft material, and a prosthesis including the contoured internal limb. The tubular segment includes a left lateral edge, a right lateral edge, a first length extending from the left lateral edge to the right lateral edge, and a second length extending from a proximal end to a distal end of the tubular segment. The method also includes contouring a proximal portion, a middle portion, and a distal portion of the contoured internal limb from the tubular segment. The method also includes closing a right lateral edge of the proximal portion and a right lateral edge of a first section of the middle portion. The method further includes removing the proximal, middle and distal portions of the contoured internal limb from the tubular segment and maintaining a second section of the middle portion as circumferentially continuous.

Abstract: A bifurcated stent graft includes a stent graft body that defines exactly one main body opening and at least two exit openings. The stent graft body includes at least one stent attached to a graft fabric material, and includes a dividing wall that divides a combined flow path, into a first flow path and a second flow path that each terminate at one of the respective exit openings. The dividing wall includes a thickness profile that terminates at a leading edge radius that extends across a width of the combined flow path.

Abstract: The sinus venosus atrial septal defect (“ASD”) treatment device includes has a generally tubular or funnel shaped configuration. A first end of the device can have a diameter that is less than a diameter of a second end of the device. The device can be inserted in the right upper right pulmonary vein PV. The second end of the device is configured to expand in a skirt-like configuration once the device is positioned in the right upper right pulmonary vein PV. In this manner, the device closes the upper sinus venosus hole and diverts anomalous pulmonary venous drainage into the left atrium.

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: The present disclosure provides medical devices, systems and methods and in particular to devices and methods useful for anchoring graft materials to bodily structures.

Abstract: An implantable device and method are disclosed for stenting an occlusion of an airway. The implantable device includes a cylindrical tube shaped proximal region, a flared distal region, and a non-bifurcated single lumen extending through the device. The proximal region defines a proximal portion of the lumen and the distal region defines a distal portion of the lumen. The distal region may flare outward laterally at a first angle and anteroposterior at a second angle, thereby forming an elliptically shaped distal opening to the lumen. The distal edge of distal opening may lie entirely in a plane orthogonal to a longitudinal axis of the device. Alternatively, the distal edge may be non-planar, such as concave or convex, when viewed in an anteroposterior direction. The implantable device may be formed of a scaffolding structure.

Abstract: A vascular prosthesis configured for direct connection to an artery. The vascular prosthesis may include a tube of material other than autologous vascular tissue, having an end formation, which is configured for surgical connection to an opening formed in the artery, and a narrower portion prior to commencement of the end formation. The end formation may have an enlarged chamber adapted to induce a concave section in the blood vessel upon attachment thereto.

Abstract: Vascular devices and methods for addressing aortic pathologies are provided that facilitate hemostasis at the junctions of the ends of the device with the native aorta or other vessels to minimize or eliminate the risk of endoleaks. One or both ends of the device may include inner and outer skirts that are configured to receive a section of native blood vessel therebetween. The outer skirt may be flared in some cases or rolled up prior to placement at and engagement with the blood vessel to provide clearance for joining the blood vessel to the inner skirt of the device, such as via sutures. Once engaged, the outer skirt is disposed such that the blood vessel is between the inner and outer skirts. Devices and associated methods are also described that allow endografts to be deployed and engaged with an end of the device in areas with insufficient landing zones.

Abstract: A stent (10) for use in a prosthetic heart valve has an annulus section (12) adapted for placement within the ? leaflets and annulus of the native heart valve. The annulus section has latch members (50) adapted to engage the leaflets of the native heart valve when prosthetic valve is implanted in the native valve. The latch members may hold the leaflets in engagement with the annulus section, and help to retain the prosthetic valve in position. The annulus section may have a non-circular cross-sectional shape.

Abstract: An anastomotic connector comprises a generally tubular access port having a first end and a second end and a main body portion in fluid communication with the second end of the access port that is structured to be deployed within a fluid passageway. The main body portion includes an expandable mesh frame defining a pair of flanges extending outwardly from the second end of the access port and a retention strap extending across the second end of the access port. The pair of flanges and the retention strap are structured to exert a radial force on an internal surface of a fluid passageway when the mesh frame of the main body portion is expanded within the fluid passageway. Furthermore, the pair of flanges and the retention strap allow the passage of fluid to the distal tissues that the native fluid passageway is supplying.

Abstract: A tubular side arm assembly configured for mounting onto a stent graft to provide an accessible side arm. The side arm includes a lightweight space frame comprising a resilient wire, and the space frame comprises a cylindrical portion and a funnel portion. The cylindrical portion includes first and second circular planar ring portions that are parallel to each other and spaced apart axially, and at least two longitudinal struts extending between the first and second circular ring portions. The frame also includes a funnel portion including a substantially circular ring portion to define a larger end of the funnel portion and a pair of spaced apart antis extending from the substantially circular ring portion towards the cylindrical portion. The lightweight space frame is configured to support a biocompatible graft material.

Abstract: A reperfusion system and method of perfusing a blood vessel using the reperfusion system are provided. The system includes an introducer sheath, a middle catheter extending through the introducer sheath, and a balloon microcatheter extending through the middle catheter. A connecting tube extends between a lumen of the introducer sheath and a valve at a proximal end of the microcatheter. A flow path is defined along a lumen of the introducer sheath, through the connecting tube, into the microcatheter, and out of a distal opening of the microcatheter. The balloon is disposed adjacent the exit point of the flow path to reduce reflux. Embolic material can be introduced into the microcatheter at the valve to exit at the same location as the blood flow.

Abstract: A prosthetic aortic conduit (1) for use during surgery on the aorta of a patient. The conduit includes an elongate tubular portion (10) extending along a longitudinal axis (11) between a first conduit terminal end (12) and a second conduit terminal end (13). The first conduit terminal end (12) is configured with two substantially U-shaped tongues (21, 22) extending away from the tubular portion (10) generally along the longitudinal axis (11). Each of the tongues (21, 22) is appropriately sized to together collectively approximate the shape of the scalloped bicuspid valve annulus. The second conduit terminal end (13) is configured with three substantially U-shaped tongues (31, 32, 33) extending away from the tubular portion (10) generally along the longitudinal axis (11). Each of the tongues (31, 32, 33) is appropriately sized to together collectively approximate the shape of the scalloped tricuspid valve annulus.

Abstract: A small vessel stent graft with a fixation coupling that has a hyperboloid shape positioned at or near the proximal end of the graft. The coupling may be deployed within the fenestration of a fenestrated graft to provide multi-directional movement without compromising the integrity of the sealing zone.

Abstract: A medical implant (20) includes first and second ring members (22, 24), each including a resilient framework (26) having a generally cylindrical form. A tubular sleeve (28) is fixed to the first and second ring members so as to hold the ring members in mutual longitudinal alignment, thereby defining a lumen (32) passing through the ring members. A constricting element (30) is fit around the sleeve at a location intermediate the first and second ring members so as to reduce a diameter of the lumen at the location.

Abstract: An abdominal aortic stent includes a first sub-stent and a second sub-stent each having a front end. The circumference of the front end of each sub-stent is half of the circumference of the abdominal aorta. When the circumference is gradually reduced to a rear end of each sub-stent, it has entered one side of the bilateral femoral arteries. The rear ends of the sub-stents with full circumference of the cross-sectional area of the femoral artery are included therein. The first and second sub-stents are coated with external removable membrane to compress the sub-stents to generate smaller circumferences. When the removable membrane has been removed, the sub-stents are fully extended to reconstruct the vascular flow path.

Abstract: A method of treating a native heart valve includes delivering a replacement valve to the native heart valve. The native heart valve can be any one of aortic, pulmonary, mitral and tricuspid valves. The replacement valve comprising an expandable frame and a valve body attached to the expandable frame. The method can also include expanding the frame at a patient's valve annulus, wherein expansion of the frame causes respective ends of both proximal anchors and distal anchors connected to the frame to draw closer together to grasp native tissue between the respective ends of the proximal anchors and distal anchors.

Abstract: A hybrid prosthesis for deployment in a body vessel includes a tubular stent body comprising a wire comprising a shape memory alloy, where the tubular stent body has a self-expanding portion comprising a distal portion of the wire and a balloon-expandable portion comprising a proximal portion of the wire. The shape memory alloy comprises an Af of less than 37° C. in the self-expanding portion and an As of greater than 37° C. in the balloon-expandable portion.

Abstract: The present disclosure relates to an endoluminal prosthesis, such as a stent graft that includes one or more fenestrations to accommodate endovascular disease, such as an aneurysm in cases where one or more side branches is involved. In one aspect, the prosthesis includes fenestrations that are pivotable to accommodate the dynamic geometry of the aortic branches. In another aspect, the pivotable fenestrations include a first perimeter, a band of flexible material attached and surrounding the first perimeter, and a second perimeter attached to and surrounding the band of flexible material. The first perimeter, band of flexible material, and second perimeter have a geometric shape. In one aspect, the prosthesis includes at least three pivotable fenestrations.

Abstract: An implant including a first tubular medical device and a second tubular medical device coaxially disposed within the first tubular medical device. Each of the first and second tubular medical devices including a tubular body having a plurality of slits extending through a sidewall to form a plurality of first and second sidewall segments respectively. The radial expansion of the first tubular medical device forms an alternating pattern of flared first side wall segments and slits disposed adjacent to a body vessel wall. The radial expansion of the second tubular medical device forms an alternating pattern of flared second sidewall segments and slits. The second tubular medical device is rotationally aligned with the first tubular medical device such that the flared second sidewall segments at least partially cover the slits disposed adjacent the body vessel wall of the first tubular medical device.

Abstract: Described is a prosthetic valve assembly comprising: a radially self-expandable stent configured to expand to bear against a wall of a native body lumen; and an implantable prosthetic valve, having a diameter, the valve being mounted inside the stent; wherein the diameter of the stent is greater than the diameter of the prosthetic valve.

Abstract: The present disclosure relates to an endoluminal prosthesis, such as a stent graft that includes one or more fenestrations to accommodate endovascular disease, such as an aneurysm in cases where one or more side branches is involved. In one aspect, the prosthesis includes fenestrations that are pivotable to accommodate the dynamic geometry of the aortic branches.

Abstract: An endoluminal prosthesis comprises a graft having a tubular body comprising proximal and distal ends, and a valve replacement disposed between the proximal and distal ends of the graft. At least one stent is coupled to the graft and has a contracted delivery state and an expanded state for maintaining patency within a portion of the graft. At least one fenestration is disposed in a sidewall of the graft at a location distal to the valve replacement. In one embodiment, the at least one fenestration is pivotable in any direction away from an axis perpendicular to a longitudinal axis of the prosthesis.

Abstract: A device and method for treating pathological narrowing of fluid-carrying conduits of the human body (such as blood vessels) in an area of a bifurcation is disclosed. In particular, a stent delivery system configured to carry one or more of a pair of dissimilar stents. At least one of the stents is particularly suited for treating a widened portion of a blood vessel immediately proximal to a bifurcation. The stent delivery system can also include a handpiece adapted to selectively deliver the stents.

Abstract: Various stents and stent-graft systems for treatment of medical conditions are disclosed. In one embodiment, an exemplary stent-graft comprises first and second stents, which each may comprise a series of distal apices disposed distal to a proximal end of the graft, and a series of proximal apices disposed proximally beyond the proximal end of the graft. In one example, the first stent comprises a first uniform segment, and the second stent comprises a second uniform wire segment, where the first uniform segment comprises portions disposed both internal and external to the second uniform wire segment.

Abstract: The present invention provides docking heads to be mounted on a graft so as to establish a vascular device that is coupled to a blood vessel with aneurysm, and dedicated delivery devices as well as methods of coupling. The vascular device comprises a graft having docking head at the proximal portion and another docking head at its distal portion, or two docking heads if the graft is bifurcated. The docking heads comprises a hollow truncated cone having a passage adapted to correspond the outer diameter of the graft and is provided with a plurality of outwardly pointing and inclined barbs. The vascular device is coupled to the blood vessel on both sides of the aneurysm while the docking heads act as guiding, anchoring and sealing means in a suture-less and rapid manner. The vascular device is modular and can be prepared according to the condition of the aneurysm and the dimensions of the blood vessels during operation.

Abstract: A stent graft includes at least one aperture extending through the main body thereof, into which an extension portion may be deployed for positioning within an adjacent branch flow lumen. The extension portions include self biasing features, wherein the extension is biased into engagement with the main body to seal the interface thereof. Additionally, the extension portion may be configured for tortuous or deviated anatomy, to enable sealing of the extension portion with the body while extending the extension portion in a substantially non-radial direction from the main body.

Abstract: The present disclosure relates to an endoluminal prosthesis, such as a stent graft that includes one or more fenestrations to accommodate endovascular disease, such as an aneurysm in cases where one or more side branches is involved. In one aspect, the prosthesis includes fenestrations that are pivotable to accommodate the dynamic geometry of the aortic branches. In another aspect, the pivotable fenestrations include a first perimeter, a band of flexible material attached and surrounding the first perimeter, and a second perimeter attached to and surrounding the band of flexible material. The first perimeter, band of flexible material, and second perimeter have a geometric shape.

Abstract: A method is provided for treating a cardiovascular disease, such as pulmonary arterial hypertension, an arrhythmia, or heart failure. One step of the method includes providing an apparatus. The apparatus includes an expandable support member having oppositely disposed proximal and distal end portions and a main body portion extending between the end portions. The proximal end portion includes a plurality of wing members extending from the main body portion. At least a portion of the expandable support member is treated with at least one therapeutic agent for eluting into a blood vessel. The expandable support member is inserted into the pulmonary vasculature and then advanced to a bifurcation in the pulmonary vasculature. The bifurcation includes the intersection of a first pulmonary vessel, a second pulmonary vessel, and a third pulmonary vessel. The expandable support member is secured at the bifurcation to treat pulmonary arterial hypertension, for example.

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: The intravascular stent is formed from a composite wire includes an inner core of radiopaque metal, a polymer layer coaxially disposed about the inner core, and an outer metal layer coaxially disposed about the polymer layer. The intermediary polymer layer acts as a barrier material between the inner core and the outer sheath, so that the inner core and outer sheath may be made of dissimilar metallic layers, and the intermediary polymer layer will prevent a galvanic reaction between the inner core and the peripheral metal layer. The intravascular stent has ends flared radially outwardly to prevent radially and longitudinally inward deformation of the ends of the stent when the stent is disposed in a desired location in a patient's vasculature.

Abstract: The intravascular stent is formed from a composite wire includes an inner core of radiopaque metal, a polymer layer coaxially disposed about the inner core, and an outer metal layer coaxially disposed about the polymer layer. The intermediary polymer layer acts as a barrier material between the inner core and the outer sheath, so that the inner core and outer sheath may be made of dissimilar metallic layers, and the intermediary polymer layer will prevent a galvanic reaction between the inner core and the peripheral metal layer. The intravascular stent has ends flared radially outwardly to prevent radially and longitudinally inward deformation of the ends of the stent when the stent is disposed in a desired location in a patient's vasculature.

Abstract: A leg extension (10) for a stent grafting system to connect between an aortic graft and an iliac graft. The leg extension is a tubular body (12) of a biocompatible graft material with self-expanding stents connected along the length of the tubular body and the tubular body having a distal end with a connection region. The connection region has a flared stent defining an external frusto-conical surface to provide a connection arrangement to engage within an internally flared portion of an iliac graft.

Abstract: A stent for positioning within a lumen is provided. The stent includes a stent region and a pair of transition regions extending from respective ends of the stent region, wherein each of the transition and stent regions define an aperture therethrough. At least a portion of at least one of the transition regions is configured in a helix including a plurality of turns, wherein the stent region is capable of expanding to conform to a stricture and each of the transition regions is capable of expanding to conform to the lumen proximally and distally of the stricture.

Abstract: A self-sealing vascular graft, including a substrate with a sealant layer and several optional additional layers, is described. The substrate can be ePTFE and the material used for the sealant and additional layers can be polyurethane. The sealant layer and additional layers may include one or more base layers, one or more foam layers, beading of different sizes and shapes, and ePTFE tape. A flared cuff may be integral to one or both ends of the substrate or may be attached to one or both ends. Various methods of making a self-sealing vascular graft are also described, including methods of disposition, methods of forming, methods of bonding and methods of attaching.

Abstract: A tubular vascular transplant (1, 1?, 1?, 1??) serves for connecting vessels in the human body. The transplant, in particular made of expanded polytetrafluoroethylene (ePTFE), can preferably be used for an arteriovenous shunt for carrying out a dialysis. The transplant is connected by its first, proximal end to a vessel, for example an artery (2), and by its distal end to another location of the same vessel or to a different vessel, for example a vein (3). The lumen of the transplant (1, 1?, 1?, and 1??) widens in a steadily conical manner in the region of its distal end and forms a diffuser (8) there. The cone angle (a) of the wall of the diffuser (8) with respect to the central flow direction of the blood in the transplant (1?, 1?, 1??) is preferably 6° to 7°. In the region of the diffuser (8), preferably at least one, preferably planar, dividing wall (11, 11?, 11a, and 11b) is provided, running in the central flow direction of the blood.

Abstract: An endoluminal prosthesis is disclosed and comprises a first generally tubular stent, a second generally tubular stent, and a generally tubular graft member concentrically disposed between the first and second stents. One or more of the first and second stents may have a body portion and a flaring portion. The first and second stents each may have a recoil force such that the combined application of the first and second recoil forces secures the graft member between the first and second stents.

Abstract: A generally tubular, cylindrical stent prosthesis has an unexpanded delivery configuration and an expanded configuration for contacting the vessel wall. The stent prosthesis has a plurality of adjacent stent struts, each stent strut having a wavelike or sinusoidal pattern of straight segments and crowns. A Y-shaped member is attached to one or more crowns to cause the crowns to flare outwardly at an angle from the cylindrical stent body when the stent is expanded. Upon expansion of the stent, the crown(s) having Y-shaped members attached thereto are angled with respect to the longitudinal axis and radially flare from the cylindrical stent body. The flared crowns anchor the stent within the vessel by protruding into the vessel wall and/or seating the stent within an ostium.

Abstract: A leg extension (10) for a stent grafting system to connect between an aortic graft and an iliac graft. The leg extension is a tubular body (12) of a biocompatible graft material with self-expanding stents connected along the length of the tubular body and the tubular body having a distal end with a connection region. The connection region has a flared stent defining an external frusto-conical surface to provide a connection arrangement to engage within an internally flared portion of an iliac graft.

Abstract: A stent in a non-expanded state has a first column expansion strut pair. A plurality of the first column expansion strut pair form a first expansion column. A plurality of second column expansion strut pair form a second expansion column. A plurality of first serial connecting struts form a first connecting strut column that couples the first expansion column to the second expansion column. The first expansion column, the second expansion column, and the first connecting strut column form a plurality of geometric cells. At least a portion of the plurality are asymmetrical geometric cells.

Abstract: An endovascular stent for vascular vessels which can be used to occlude the vessel or which can be used to bridge damaged areas in the vessel. The endovascular stent comprising a stent that can be permanently expanded from a first diameter to a larger second diameter. The stent can be a helically wound wire stent, each wire comprising at least two strands, the two strands being twisted. The twisted strands securing fibers to form a fabric pile extending outwardly from stent, and optionally extending inwardly into the stent. In a second embodiment, the stent is enclosed with a tubular-like expandable graft, the graft having an exterior fabric pile made up of individual fibers. In both embodiments, the fibers or the pile are optionally coated with a hydrophilic polymeric gel which expands upon being wetted.

Abstract: The present invention is directed to an implantable vascular prosthesis configured for use in a wide range of applications, such as treating aneurysms, maintaining patency in a vessel, and allowing for the controlled delivery of therapeutic agents to a vessel wall. The prosthesis comprises one or more helical sections coupled to one or more anchoring sections having a generally zig-zag or cell-like configuration. The prosthesis is configured to conform to a vessel wall without substantially remodeling the vessel, and further is configured to be precisely deployed in a vessel without shifting or foreshortening during deployment.

Abstract: An improved medical device for use in the treatment of stenosis of the ostium of tubular organs, such as, but not limited to blood vessels. The improved medical device includes a configuration and design that enables at least one end region of the improved medical device to flare outwardly.