Abstract: A vascular implant for an endoluminal stent or blood vessel, the stent or blood vessel defining a lumen for the passage of blood. The liner can comprise a flexible bladder arrangeable within the lumen, which can be fillable with a compressible fluid. The liner can define an inner lumen for the passage of blood. The liner and the fluid are conformable in response to a pulsatile pressure wave of the blood in the blood vessel such that the pressure within the blood vessel is reduced.

Abstract: A method of treating an aortic aneurysm of a patient with an endovascular graft system and mitigating post implant syndrome associated therewith comprises placing at least one prosthesis across an aneurysmal space. The prosthesis comprises a double-walled filling structure and a stent-graft. The stent graft is radially expanded at a first pressure and the filing structure is filled with a first filing agent to contact a thrombus in the aortic aneurysmal space. After the first filling agent is removed, the filling structure is filled with a second filling agent to contact the thrombus. Next the stent-graft is expanded at a second pressure causing the filing structure to place an effective amount of pressure on the thrombus and substantially mitigating the effects of post implant syndrome associated with the prosthesis.

Abstract: This invention relates to an aneurysm occluder, and more particularly but not exclusively, to an endovascular aneurysm occluder that can be inserted into an aneurysm cavity by using endovascular surgical procedures. The aneurysm occluder has a deformable housing and an absorber or material that causes blood clotting made of an absorbent material in or attached to the housing.

Abstract: A transcatheter prosthetic heart valve includes a stent frame and at least one sheet of leaflet material formed in to a tube, which includes a lower portion disposed on an exterior of the stent frame and an upper edge portion disposed within the stent frame. The upper edge portion includes at least a portion configured to wrap around a first portion of the top edge of the stent frame and fold towards an exterior of the stent frame. The upper edge portion also includes at least another portion configured to weave through the stent frame and fold towards the interior of the stent frame.

Abstract: A synthetic heart valve is made from a valve graft of synthetic material and more particularly expanded polytetrafluoroethylene (ePTFE). The valve graft has an upper portion defined by a first thickness and a lower portion defined by a second thickness which is greater than the first thickness. The valve graft is formed into a cylindrical sleeve having a diameter and a folded region. A flexible stent overlays the cylindrical sleeve, wherein a series of leaflets are formed in the lower portion of the sleeve, the leaflets defining a semicircular perimeter. The leaflets are sutured to the cylindrical sleeve and the cylindrical sleeve is sutured to the flexible stent, the stent having a plurality of bent cylindrical wire segments that are welded together and in which the sleeve is sutured to the wire, including the welded areas of the stent. The formed valve can be implanted using a balloon catheter.

Abstract: Some embodiments described herein include a heart valve replacement system that may be delivered to the targeted heart valve site via a delivery catheter. In some embodiments, the heart valve replacement system can assemble a valve device after the valve device is delivered to the heart. In some embodiments, heart valve replacement system includes two anterior flaps that are separate but overlap each other.

Abstract: A system includes an inner filling structure around a stent-structure and an outer filling structure around the inner filling structure. The inner filling structure can be configured to produce a proximal seal with a first portion of an artery at a proximal end and a distal seal with a second portion of an artery at a distal end when the inner filling structure is in an inflacted state. The outer filling structure can have an inner surface surrounding at least a portion of the inner filling structure. The outer filling structure can be configured to be inflatable to occupy a space within an aneurysm at a lower pressure than a pressure in the inner filling structure.

Abstract: A prosthetic heart valve for replacing a native valve includes a collapsible and expandable stent extending between a proximal end and a distal end. The stent includes an annulus section adjacent the proximal end and having a first diameter, a plurality of first struts forming cells, and a plurality of second struts connected to the annulus section and forming a plurality of deflecting cells expandable to define a second diameter larger than the first diameter. A valve assembly is disposed within the stent and a cuff is coupled to the stent and covers the plurality of deflecting cells.

Abstract: A graft having a tubular body having a first end configured for attachment to a first vessel having a first compliance and second end configured for attachment to a second vessel having a second compliance different from the first compliance, and having a plurality of compressible chambers in the wall of the tubular body in which the chamber adjacent the first end of the tubular body is less compressible than the chamber adjacent the second end of the tubular body such that first end of the tubular body substantially matches the first compliance and the second end of the tubular body substantially matches the second compliance.

Abstract: Devices and methods for the treatment of heart conditions are provided herein. For example, this document provides devices and methods for treating tricuspid valve regurgitation by percutaneously implanting a prosthetic tricuspid valve.

Abstract: The present disclosure relates generally to the field of stents for body lumen drainage. In particular, the present disclosure relates to systems and methods for forming a fluid channel between tissue walls of varying thickness using a stent.

Abstract: Methods and devices are disclosed for treating neurovascular venous outflow obstructions, with or without implantation of a prosthetic valve. The valve may be carried by a support, such as a stent, which may be self-expandable or balloon expandable. Both transvascular and direct surgical access is contemplated.

Abstract: Systems and methods for medical interventional procedures, including approaches to valve implantation. In one aspect, the methods and systems involve a modular approach to mitral valve therapy.

Abstract: A system for repairing a defective heart valve. The system includes a delivery device, a balloon and a prosthetic heart valve. The delivery device includes an inner shaft assembly and a delivery sheath assembly. The delivery sheath assembly provides a capsule terminating at a distal end. The prosthesis includes a stent carrying a prosthetic valve. In a delivery state, the capsule maintains the prosthesis in a collapsed condition over the inner shaft assembly, and the balloon is in a deflated arrangement radially between the prosthetic heart valve and the capsule. In a deployment state, at least a portion of the balloon and at least a portion of the prosthetic heart valve are distal the capsule. Further, the balloon is inflated and surrounds an exterior of at least a portion of the prosthetic heart valve. The balloon controls self-expansion of the prosthetic heart valve.

Abstract: This document provides devices and methods for the treatment of heart conditions such as valvular stenosis. For example, this document provides devices and methods by which a guide catheter can align itself with a blood flow stream to thereby help direct a guidewire or other elongate device transmitted from the guide catheter through an orifice of a heart valve.

Abstract: A method for performing a diagnostic or therapeutic procedure on a partial occlusion within a blood vessel, includes positioning a guide having a sensor configured and adapted to measure at least one of pressure, volume or flow within a blood vessel, advancing the guide through an at least partial occlusion within the blood vessel such that the sensor is downstream of the occlusion, measuring at least one of pressure, volume or flow downstream of the occlusion using the sensor and analyzing data obtained from the sensor to assist in determining the viability of tissue of the blood vessel downstream of the occlusion.

Abstract: A prosthetic valve assembly for implantation in a patient's circulatory system includes a stent, a valve member coupled to the stent and defining a preferred landing zone relative to anatomical structures in the patient's circulatory system, and at least one marker positioned in a predetermined relationship relative to the landing zone of the valve member, the marker being visually distinguishable from the stent using an imaging technique. By observing the marker, the prosthetic valve assembly may be implanted in the patient so that certain ones of the anatomical structures lie within the landing zone.

Abstract: This document provides devices and methods for the treatment of heart conditions such as valvular stenosis. For example, this document provides devices and methods by which a guide catheter can align itself with a blood flow stream to thereby help direct a guidewire or other elongate device transmitted from the guide catheter through an orifice of a heart valve.

Abstract: A valvuloplasty device comprises an expandable anchor and an expansion member mounted about an outer surface of the expandable anchor. The expansion member is either an annular balloon or a sleeve. The valvuloplasty device can be used for valvuloplasty and for valve implantation.

Abstract: An endovascular graft, which is configured to conform to the morphology of a vessel to be treated, includes a tubular ePTFE structure; an inflatable ePTFE structure disposed over at least a portion of the ePTFE tubular structure; and an injection port in fluid communication with the inflatable ePTFE structure for inflation of the inflatable ePTFE structure with an inflation medium. The inflatable ePTFE structure may be longitudinally disposed over the tubular ePTFE structure. The ePTFE structure may be a bifurcated structure having first and second bifurcated tubular structures, where the inflatable ePTFE structure is disposed over at least a portion of the first and second bifurcated tubular structures.

Abstract: A graft for inducing helical blood flow, including a tubular body with fluid inflow and fluid outflow ends, and with inner and outer sidewalls. A lumen extends between the fluid inflow end and fluid outflow end. A compressible chamber is disposed between the outer sidewall and the inner sidewall. The compressible chamber has an incompressible seam that follows a substantially helical path around a longitudinal axis of the tubular body. When internal (e.g., blood) pressure increases on the inner sidewall, a vane element is formed that follows the substantially helical path around the longitudinal axis of the tubular body. The vane element may induce helical blood flow. The width of the compressible chamber may decrease in a compressed state (e.g., systole). The chamber may be filled with a predetermined amount of at least one of a gas, liquid, or vapor. The graft may have a second incompressible seam/vane.

Abstract: A system and a method are provided for analyzing an image of an aortic valve structure to enable assessment of aortic valve calcifications. The system comprises an image interface for obtaining an image of an aortic valve structure, the aortic valve structure comprising aortic valve leaflets and an aortic bulbus. The system further comprises a segmentation subsystem for segmenting the aortic valve structure in the image to obtain a segmentation of the aortic valve structure. The system further comprises an identification subsystem for identifying a calcification on the aortic valve leaflets by analyzing the image of the aortic valve structure.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, the stent including a plurality of struts. The heart valve further includes a collapsible and expandable valve assembly including a cuff and a plurality of leaflets, the cuff being coupled to selected ones of the plurality of struts and having microspheres disposed therein. The microspheres are capable of expanding upon contact with blood.

Abstract: An anchoring device (1) designed for anchoring a prosthetic heart valve inside a heart, includes an extraventricular part (2) designed to be positioned inside an atrium or an artery and a ventricular part (3) designed to be positioned inside a ventricle, wherein the ventricular part includes a double wall composed of an outer wall (4) and an inner wall (5) spaced apart at the level where the prosthetic heart valve is intended to be inserted, and wherein the anchoring device further includes a predefined V-shaped groove (8) formed between the extraventricular part (2) and the ventricular part (3). The present invention also relates to an anchoring system (11) for anchoring a prosthetic heart valve inside a heart, including the anchoring device (1), a prosthetic heart valve support (12) and a prosthetic heart valve (13) connected to the prosthetic heart valve support (12).

Abstract: An endovascular graft, which is configured to conform to the morphology of a vessel to be treated, includes a tubular ePTFE structure; an inflatable ePTFE structure disposed over at least a portion of the ePTFE tubular structure; and an injection port in fluid communication with the inflatable ePTFE structure for inflation of the inflatable ePTFE structure with an inflation medium. The inflatable ePTFE structure may be longitudinally disposed over the tubular ePTFE structure. The ePTFE structure may be a bifurcated structure having first and second bifurcated tubular structures, where the inflatable ePTFE structure is disposed over at least a portion of the first and second bifurcated tubular structures.

Abstract: An occlusion device includes first and second crossing frame elements each of annular ring-shape, as well as first and second annular support elements connected to respective extremities of the crossing frame elements. The frame and support elements are provided with covers made of a substantially impervious material. The occluder may include a covering sleeve of stretchable material. The occluder substantially stops or reduces the flow of blood therethrough, creating blood statis and subsequent occlusion by clot formation within the occluder. The structure of the frame elements ensures good edge sealing and enhanced fixation of the occluder in a vessel as blood pressure impinges upon the covers of the occluder.

Abstract: Some embodiments relate in part to endovascular prostheses and delivery catheter systems and methods for deploying same. Embodiments may be directed more specifically to graft bodies having self-expanding members, including inflatable graft bodies, and catheters and methods for deploying same within the body of a patient.

Abstract: A cardiovascular prosthetic valve, the valve comprising an inflatable cuff comprising at least one inflatable channel that forms, at least in part, an inflatable structure, and a valve coupled to the inflatable cuff, the valve configured to permit flow in a first axial direction and to inhibit flow in a second axial direction opposite to the first axial direction, the valve comprising a plurality of tissue supports that extend generally in the axial direction and that are flexible and/or movable throughout a range in a radial direction.

Abstract: The present disclosure provides aortic valve prosthetic devices that are constructed in a non-axisymmetric shape, or are expandable to a non-axisymmetric shape for improved results in the repair of defective aortic valves. The devices can be surgically implanted, or they can be implanted percutaneously through an insertion catheter. The expandable devices can be self-expanding or expanded by an inflatable balloon to a non-axisymmetric cross-section geometry.

Abstract: Prosthetic valve devices for implantation in body vessels are provided. The prosthetic valve device includes at least one flexible member that permits fluid flow in a first direction and substantially prevents fluid flow in a second. The valve device also includes an inflatable chamber at least partially attached to the flexible member. The inflatable chamber is adapted to receive inflating media and is adapted to contact the body vessel. A delivery system is also provided that includes a valve device and a delivery apparatus. The delivery apparatus includes a member adapted for filling the chamber of the valve device with inflating media. A related method of making the valve device is also provided.

Abstract: A method and apparatus for suture-less placement of an occluding patch in which release of the device can be accelerated. In one embodiment, an inactive form of an adhesive is applied on the area of the patch that will come into contact with cardiac tissue; this allows for the introduction and necessary manipulation of the catheter system until activation of the adhesive occurs. In accordance with one aspect of the invention, the adhesive properties of certain polymeric materials are relied upon rather than their ability to cure or harden into a specific shape. In another embodiment, the patch is immediately released utilizing a detaching mechanism on the balloon or the balloon catheter which supports the patch; the patch along with the inflated balloon remain on the cardiac structure occluding the opening.

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: This invention is a system for the treatment of body passageways; in particular, vessels with vascular disease. The system includes an endovascular graft with a low-profile delivery configuration and a deployed configuration in which it conforms to the morphology of the vessel or body passageway to be treated as well as various connector members and stents. The graft is made from an inflatable graft body section and may be bifurcated. One or more inflatable cuffs may be disposed at either end of the graft body section. At least one inflatable channel is disposed between and in fluid communication with the inflatable cuffs.

Abstract: A device for occluding a septal defect is provided. In general, the occluding device has a contracted state that allows the occluding device to be received within a delivery device for deployment to the site of the defect and an expanded state that is achieved when the occluding device is deployed from the delivery device. The occluding device has a proximal portion, which may be substantially circular, a distal portion, which may be substantially ovaloid, and a connecting portion extending between the two. The distal portion may define first and second outer parts at opposite ends of the major axis, which may be bent or curved. The configuration of the proximal and distal portions allow the occluding device to securely engage the septal wall and be kept in position at the septal defect without causing substantial interference with the functioning of adjacent heart structures.

Abstract: An endovascular graft, which is configured to conform to the morphology of a vessel to be treated, includes a tubular ePTFE structure; an inflatable ePTFE structure disposed over at least a portion of the ePTFE tubular structure; and an injection port in fluid communication with the inflatable ePTFE structure for inflation of the inflatable ePTFE structure with an inflation medium. The inflatable ePTFE structure may be longitudinally disposed over the tubular ePTFE structure. The ePTFE structure may be a bifurcated structure having first and second bifurcated tubular structures, where the inflatable ePTFE structure is disposed over at least a portion of the first and second bifurcated tubular structures.

Abstract: A method for assembling a stent graft onto a balloon delivery catheter is disclosed. The method includes the steps of: assembling a graft over a stent with attached security rings and inserting the ends of the graft between the stent and the rings; placing the assembled stent graft on the delivery balloon of the delivery catheter; and crimping the stent graft onto the balloon. The stent may include a plurality of axially aligned belts that include a plurality of mid belts, and first and second end belts, where each of the mid belts includes a plurality of circumferentially spaced struts having first and second ends adjoining first sinusoidal-shaped elements, and each of the first and second end belts includes at least about twice the number of circumferentially spaced struts adjoining second sinusoidal-shaped elements. Also disclosed is a stent graft for use in practicing the method.

Abstract: An improved vascular graft having increased patency is disclosed herein. The graft may comprise a central or other stenosis. In addition, in some embodiments, the graft may comprise an internal reservoir and a collapsible portion configured to self-adjust the stenosis based on blood flow pressure. The graft may comprise an endothelial lining, one or more drug eluting materials, or both to increase patency by respectively reducing clots and preventing unwanted cellular or fibrin growth. The endothelial lining may be formed from one or more endothelial cells artificially grown or harvested from a patient's vascular system.

Abstract: A stent graft defining a main lumen bounded by a wall of graft material is disclosed. The stent graft has a valve portion between proximal and distal portions. The valve portion is formed by a wall portion having a part-circumferential double layer portion comprising an inner underlap portion and an outer overlap portion, the double layer portion forming a passageway parallel to the main lumen. The passageway has an entrance mouth and an exit mouth. The passageway has an open condition where the underlap and overlap portions are spaced apart to form a vent lumen. The wall portion is broken by a narrow cut. The cut is openable by relative radial movement between its edges. This allows re-perfusion of an aneurism and perfusion of blood from within the lumen out towards blood vessels such as intercostals and can assist in minimizing the chance of paraplegia.

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 prosthetic venous valve includes a self-expanding tubular body defining a fluid passageway and a pair of opposing leaflets biased in a closed configuration in which free edges of the leaflets form a scalloped commissure. The free edges may be pre-formed and/or reinforced in order to ensure sealing with each other in a consistent manner. In response to a pressure differential, the free edges of the leaflets are configured to diverge to form an elliptical outflow opening that allows flow through the tubular body. The valve leaflets may include longitudinal support wires to prevent collapse thereof.

Abstract: An endovascular conduit device and method for use during cardiac lead extraction and other vascular procedures is presented. The endovascular conduit device includes an outer-sheath, a conduit member, a lumen member, and an inflation member to control the flow of fluid within the conduit member. The endovascular conduit device may be positioned intravascularly as cardiac lead extraction or other procedures are performed. If necessary, as in the case of a vascular tear, the endovascular conduit device further includes expandable members that are activated to allow blood to be forced into the channel of the conduit member. Blood may then be contained and directed safely to bypass the area of vessel injury. In doing so, a catastrophic circulatory collapse or shock is prevented.

Abstract: An endovascular conduit device and method for use during cardiac lead extraction and other vascular procedures is presented. The endovascular conduit device includes an outer-sheath, a conduit member, a lumen member, and an inflation member to control the flow of fluid within the conduit member. The endovascular conduit device may be positioned intravascularly as cardiac lead extraction or other procedures are performed. If necessary, as in the case of a vascular tear, the endovascular conduit device further includes expandable members that are activated to allow blood to be forced into the channel of the conduit member. Blood may then be contained and directed safely to bypass the area of vessel injury. In doing so, a catastrophic circulatory collapse or shock is prevented.

Abstract: Devices, systems and methods are disclosed for the formation of an arteriovenous fistula in the limb of the patient. Embodiments include an apparatus for the creation, modification and maintenance of a fistula, including the modification of an existing dialysis fistula; and a method of supplying oxygenated blood to the venous circulation of a patient. A kit of anastomotic implants is described which supports a broad base of patient anatomies and fistula locations. The devices, systems and methods can be used to treat patients with one or more numerous ailments including chronic obstructive pulmonary disease, congestive heart failure, hypertension, hypotension, respiratory failure, pulmonary arterial hypertension, lung fibrosis and adult respiratory distress syndrome.

Abstract: An endovascular graft, which is configured to conform to the morphology of a vessel to be treated, includes a tubular ePTFE structure; an inflatable ePTFE structure disposed over at least a portion of the ePTFE tubular structure; and an injection port in fluid communication with the inflatable ePTFE structure for inflation of the inflatable ePTFE structure with an inflation medium. The inflatable ePTFE structure may be longitudinally disposed over the tubular ePTFE structure. The ePTFE structure may be a bifurcated structure having first and second bifurcated tubular structures, where the inflatable ePTFE structure is disposed over at least a portion of the first and second bifurcated tubular structures.

Abstract: Disclosed is a flow control device for a bronchial passageway. The device can includes a valve member that regulates fluid flow through the flow control device, a frame coupled to the valve member, and a membrane attached to the frame. At least a portion of the flow control device forms a seal with the interior wall of the bronchial passageway when the flow control device is implanted in the bronchial passageway. The membrane forms a fluid pathway from the seal into the valve member to direct fluid flowing through the bronchial passageway into the valve member.

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 treatment of COPD, hypertension, and left ventricular hypertrophy, and chronic hypoxia including creation of an artificial arterio-venous fistula and installation of a flow mediating device proximate the fistula. The flow mediating device is operated to limit flow as medically indicated to provide the optimum amount of bypass flow.

Abstract: The endovascular graft includes a dual chamber cuff structure. The endovascular graft includes a tubular structure having a first end and a second end. The tubular structure has a wall defining a lumen between the first and second ends. The endovascular graft includes a cuff circumferentially secured to the tubular structure. The cuff has an interior cavity which is bifurcated such that the interior cavity includes a circumferential outer chamber and a circumferential inner chamber. The method for forming the endovascular graft includes inserting an expansion substance into the inner chamber to resist a luminal intrusion of the tubular structure resulting from the insertion of the expansion substance into the outer chamber. The expansion substance within the outer chamber is stiffened. The expansion substance within the inner chamber is removed.

Abstract: A method for assembling a stent graft onto a balloon delivery catheter is disclosed. The method includes the steps of: assembling a graft over a stent with attached security rings and inserting the ends of the graft between the stent and the rings; placing the assembled stent graft on the delivery balloon of the delivery catheter; and crimping the stent graft onto the balloon. The stent may include a plurality of axially aligned belts that include a plurality of mid belts, and first and second end belts, where each of the mid belts includes a plurality of circumferentially spaced struts having first and second ends adjoining first sinusoidal-shaped elements, and each of the first and second end belts includes at least about twice the number of circumferentially spaced struts adjoining second sinusoidal-shaped elements. Also disclosed is a stent graft for use in practicing the method.

Abstract: Prosthetic valve devices for implantation in body vessels are provided. The prosthetic valve device includes at least one flexible member that permits fluid flow in a first direction and substantially prevents fluid flow in a second. The valve device also includes an inflatable chamber at least partially attached to the flexible member. The inflatable chamber is adapted to receive inflating media and is adapted to contact the body vessel. A delivery system is also provided that includes a valve device and a delivery apparatus. The delivery apparatus includes a member adapted for filling the chamber of the valve device with inflating media. A related method of making the valve device is also provided.