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: A temporary diameter reduction constraint arrangement for a stent graft is disclosed. The arrangement comprises: primary and secondary release wires extending along the graft; a plurality of loops of thread, each loop engaged with either the primary or secondary wire and engaged around a portion of the graft circumferentially spaced away from its release wire, and drawn tight to reduce the diameter of the graft; an end constraint arrangement comprising four of the plurality of loops of thread arranged into a first and second pairs engaged with respective primary and secondary wires; and an intermediate constraint arrangement comprising a fifth and sixth of the plurality of loops of thread arranged into a third pair, the third pair engaged with the primary release wire, the primary release wire deviating towards the secondary release wire so as to locate the intermediate constraint arrangement substantially in-line with the end constraint arrangement.

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: 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 stent graft includes a stent graft material of tubular shape and annular shaped stent elements coupled to the stent graft material. The stent graft further includes hooked fixation elements, having hook-end portions and coupling-end, circumferentially spaced about an annular shaped spring attachment element, and coupled to the stent graft at apexes of the spring attachment element. Before deployment the hook-end portions of the apexes of the attachment element and the hooked fixation elements attached thereto are compressed within the space bounded by the interior and exterior sides of the spring attachment element and angled laser cut strut inner surfaces under each apex of the spring attachment element are cut at an angle to cause apex and hook rotation at expansion and deployment.

Abstract: An implantable medical device includes a frame that includes at least one elongate member. The implantable medical device also includes a fixation member that has a first cuff, a second cuff, a tissue engagement member configured to anchor to tissue at an implant site to thereby hold the implantable medical device in a position at the implant site, and a cuff joining member that has an arcuate shape and that is connected at a first end to the first cuff and at a second end to the second cuff. The first cuff substantially surrounds a perimeter of a first portion of the at least one elongate member, the second cuff substantially surrounds a perimeter of a second portion of the at least one elongate member, and the cuff joining member does not substantially surround a perimeter of any portion of the at least one elongate member.

Abstract: A flexible low profile delivery system for delivery of an expandable intracorporeal device, specifically, an endovascular graft, which has at least one belt circumferentially disposed about the device in a constraining configuration. The belt is released by a release member, such as a release wire, by retracting the wire from looped ends of the belt. Multiple belts can be used and can be released sequentially so as to control the order of release and placement of the endovascular graft. An outer protective sheath may be disposed about the endovascular graft while in a constrained state which must first be refracted or otherwise removed prior to release of the graft from a constrained state. The delivery system can be configured for delivery over a guiding device such as a guidewire. The delivery system can also be configured for delivery of bifurcated intracorporeal devices.

Abstract: An endoluminal prosthesis that includes a support structure comprising a curvilinear portion having a first strut and a second strut that meet at an apex. Disposed on the support structure is an anchor with an anchor body and one or more barbs extending outwardly from the anchor body and where the anchor body comprises a multi-filar tube fits at least partially about, and conforms to the first strut, second strut, and the apex.

Abstract: A total aortic arch reconstruction graft, including a first, hollow cylindrical segment in the shape of an aortic arch, a second, hollow cylindrical segment having a first end joined to the second end of the first segment, and a second end adapted to be inserted into the descending aorta of a patient, the second segment having an expandable outer wall covered with an expandable stent, and a collar having a diameter larger than the diameter of said first segment, the collar located at a juncture where the first end of the second segment is joined to the second end of the first segment, with a plurality of separate, non-absorbable double-armed sutures pre-attached to the collar. A surgical procedure for total replacement of a patient's aortic arch is also disclosed.

Abstract: The present embodiments provide stents and stent-grafts for use in medical procedures. In one embodiment, a stent comprises a series of proximal apices, a series of distal apices, and at least one imaging element. A distal region of the stent, including the series of distal apices and a first suture bore, overlaps with the graft material, while a proximal region of the stent, including the series of proximal apices and at least one barb, is disposed proximally beyond the graft material. In an alternative embodiment, a stent-graft comprises a graft, a first stent and a second stent, in which a series of proximal apices of the first stent are each disposed distal to the proximal end of the graft, and a series of proximal apices of the second stent are each disposed proximally beyond the proximal end of the graft.

Abstract: The present embodiments provide a stent comprising a plurality of interconnected strut segments that enable expansion of the stent from a delivery state to a deployed state. A first strut segment and a second strut segment, of the plurality of strut segments, each comprise frontal surfaces facing radially inward in the deployed state and rear surfaces facing radially outward in the deployed state. The frontal surface of the first strut segment is at least partially stacked behind the rear surface of the second strut segment in the delivery state. A first barb coupled to at least a portion of the first strut segment. A sharpened tip of the first barb is aligned at least partially circumferentially behind at least one strut segment in the delivery state such that the sharpened tip is not radially exposed.

Abstract: An endoprosthesis has an expanded state and an unexpanded state, the endoprosthesis includes a stent, wherein the stent has a first end, a second end, an inner surface defining a lumen, an outer surface, and a thickness defined between the inner surface and the outer surface; and a stent end covering disposed at one of the first and second ends, the stent end covering including a polymeric coating that includes a base and a plurality of protrusions, the base including a first major surface facing the outer surface of the stent, the base further including a second major surface from which each of the plurality of protrusions extends outwardly, the first major surface opposing the second major surface, wherein the protrusions are arranged in a micropattern. Methods of making and using an endoprosthesis are provided.

Abstract: In embodiments there is described a cardiovascular tube-shaped lockable and expandable bioabsorbable scaffold having a low immunogenicity manufactured from a crystallizable bioabsorbable polymer composition or blend.

Abstract: A vascular device comprising a body movable from a collapsed insertion position to an expanded position having a larger cross-sectional dimension. The body includes a plurality of struts. At least two elongated struts extend distally from the body. A plurality of vessel engaging members extend outwardly from the body for engaging the internal wall of a vessel. A valve is movable between a collapsed delivery position and an expanded placement position, wherein at least a portion of the valve extends distally from the body in the delivery and placement positions and the elongated struts engage a distal portion of the valve in the placement position of the valve to retain the valve.

Abstract: The present invention provides apparatus and methods for a conduit, such as an implantable conduit for a vessel. The conduit may comprise a main member and a side-branch member. The conduit may be implanted with the side-branch member initially disposed within the main member. When positioned, the side-branch member may then be extended from within the main member and into a vessel side-branch. The materials for the conduit may include circumferentially distensible and/or low recoil materials. The materials for the conduit may be constructed by various techniques and may include materials with enhanced flexibility and kink resistance.

Abstract: A vascular prosthesis comprising a tubular shaped expandable ECM member and at least one anchoring mechanism. In one embodiment, the anchoring mechanism comprises proximal and distal single or dual-ring anchors. In one embodiment, the anchoring mechanism comprises a multiple-ring anchor. The anchors preferably comprise a biodegradable metal, such as magnesium. The anchors can also comprise a shape memory alloy, such as nitinol, and a cross-linked ECM material. In some embodiments, the ECM member includes a pharmacological agent.

Abstract: An apparatus is provided that includes a graft for coupling two vascular conduits within a patient. The graft includes: 1) an anchor system that forms an arc at one end of the conduits; and 2) a body element coupled to the anchor system. The anchor system comprises a biodegradable stent. In particular embodiments, portions of the graft are either self-expandable or balloon-expandable. In still other embodiments, anchor system includes NITINOL and the anchor system is substantially self-sealing at one end of the conduits. In one embodiment, the body element comprises polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (EPTFE). In yet other embodiments, the body element includes either a gelatinous or an elastomeric coating disposed on its surface.

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 stent system 1 has a stent 2 having a hole and at least an anchor 3 having an arm 33. The stent 2 has a cylindrical shape, in which a sheet is rolled, and a plurality of holes 13 are provided thereon. A grasping portion 33A at the distal end of the arm 33 of the anchor 3 can be inserted into the holes 13. A grasping force X of the grip 3 is greater than a drag R that the holes of the stent 2 yield. The grip 3 deforms the stent 2, easily grasps the stent 2 and a biological tissue, whereby it is possible to fix the stent 2. In accordance with the present invention, it is possible to reliably fix the stent in a hollow organ.

Abstract: An extracellular matrix (ECM) construct having a biodegradable support scaffold that includes a plurality of biodegradable microneedles that are capable of piercing tissue and anchoring therein, and at least a first layer of first ECM material disposed on the top surface of the support scaffold.

Abstract: Provided are methods, devices, and systems that can be used to deploy prosthetic devices within a bodily lumen of a patient. These methods and devices can include the securement of a prosthetic valve within a vascular lumen by driving one or more fasteners from a position on an expandable device through the valve and into or through a vascular wall.

Abstract: Embodiments of the present invention relate to methods and devices for the treatment of airway obstruction, such as obstructive sleep apnea, and devices and methods that facilitate insertion and retrieval of the same. In one embodiment, disclosed is a tissue tensioner that includes an elongate flexible tether having a first end and a second end, a bone anchor configured to be connected to a patient's mandible, a tissue ingrowth implant configured to be implanted in a patient's tongue and connected to the second end of the tether, and an adjustment mechanism configured to be held by the bone anchor adjacent the patient's mandible and configured to receive the first end of the tether and configured to adjust tension in the flexible tether between the patient's mandible and tongue. Various anchors, tethers, securement mechanisms, and adjustment mechanisms that can be used with glossal and palatal remodeling systems are also disclosed.

Abstract: A stent (10) has wrapped therearound a barb element (12) formed of a length of wire provided with first and second ends (14, 16) forming barb prongs. In intermediate zone (22), the barb element (12) is wrapped or coiled. The two pronged ends (14, 16) extend out of the graft element (26) to provide an anchoring function to the medical device. As well as being wrapped onto a strut of the stent (10), the barb element (12) is sutured to the stent (10) and to the graft material (26) by suture stitching (28). The turns of the coiling or wrapping in section (22) assist in fixing the barb element (12) relative to the suture (28) and thus to the stent graft (24). The barb elements (12) could be made of any suitable material, including Nitinol. This structure of barb elements provides an effective arrangement which is easy to manufacture, which provides strong barbs able to withstand the high processing temperatures required for setting shape memory elements of the device.

Abstract: An apparatus is provided in one example embodiment and includes a body section having an upper surface, a lower surface, and an inner edge circumferentially arranged around at least a portion of an open area. The apparatus also includes a tool extending from the body section into the open area for holding a graft vessel. The lower surface of the body section opposes a receiving vessel when the tool is positioned to transfer the graft vessel to the receiving vessel, such that the graft vessel is axially accessible through the open area to be attached to the receiving vessel. In more specific embodiments, the body section has first and second opposing ends defining a gap sized to permit the vessel to pass through.

Abstract: An implantable medical support frame (104) having a central longitudinally extending axis is expandable from a collapsed configuration having a first diameter to an expanded configuration having a second diameter. The frame also includes an anchoring mechanism with an elongate member (110). At least a portion of the elongate member is slidably disposed within a retaining structure when the frame is in the collapsed configuration. When the frame expands from the collapsed configuration to the expanded configuration, a portion of the elongate member is advanced out of the retaining structure such that the portion of the elongate member protrudes radially outward of the frame at an angle to the axis, thereby forming an anchor. A length of the protruding portion of the anchor increases as the frame expands from the collapsed configuration to the expanded configuration.

Abstract: An extracellular matrix (ECM) construct comprising a biodegradable support scaffold that includes a plurality of biodegradable microneedles that are capable of piercing tissue and anchoring therein, and at least a first layer of ECM material disposed on the top surface of the support scaffold. In some embodiments, the microneedles are capable of administering a pharmacological composition to the engaged tissue.

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 that includes a plurality of quill filaments. Each quill filament includes filament material, a surface, and a plurality of quills. Each quill has a tip, a body, and a base where the body extends from the base to the tip. The quill filaments can be interwoven to form the stent or the quill filaments can be engaged to the framework of a stent.

Abstract: A stent having an inner surface and an outer surface, at least a portion of the outer surface of the stent comprising a tacky biocompatible coating comprising a tacky polymer material and to methods of delivering and deploying a stent using a tacky biocompatible coating comprising a tacky polymer material.

Abstract: A stent graft device that requires an anchor setting procedure to prevent migration of the stent, such as an endovascular anchor stent device used for treatment of an abdominal aortic aneurism, can be anchored to a blood vessel by electrosurgically disrupting portions of the blood vessel in situ to affix struts of the stent graft device to the vessel wall, replacing barbs which have been used in such devices. The stent graft device can have a wire frame and struts or a cannula stent frame body with struts cut from the cannula. The struts can be provided with openings which are filled with extracellular matrix material, which encourages and speeds ingrowth of the struts in the vessel wall.

Abstract: A tracheal stent is an expandable tubular member having a proximal end, a distal end, an inner surface, and an outer surface. Circumferentially adjacent surface protrusions extend outwardly from the outer surface of the expandable tubular member. These surface protrusions have an outer surface, a first lateral surface and a second lateral surface. When the tracheal stent is deployed, the outer surface of the surface protrusion applies a radial force to a wall of the trachea to remove an airway constriction.

Abstract: A vascular graft with trim lines is described, the trim lines providing a guide for precision shaping of the cuff. The trim lines may be printed or otherwise disposed on a surface of the cuff or included on a template designed for disposition over the cuff. The trim lines may also be disposed on a side of a pocket into which the cuff is positioned for trimming. Also described is an apparatus and method for precise trimming of a vascular graft.

Abstract: An endovascular graft includes a tubular graft body section; a radially expandable stent extending from and affixed to the graft body section. The stent includes a proximal end, a distal end and a serpentine ring configuration having a plurality of struts and apices. The stent further includes at least one barb integrally formed as an extension of each strut extending distally from a position on the strut that is distal of an adjacent proximal apex, where the at least one integrally formed barb is formed as the extension of each strut with no joint or other connection thereat.

Abstract: There is provided a device to secure a prosthesis, such as a stent graft, to the internal wall of a body lumen. The device is formed from two elongate elements each comprising a central portion with at least one arm extending therefrom. The central portions of the elements abut. Optionally, the central portions are joined together, optionally by a joining element which can act as a hinge. The terminal end of each arm can be shaped for engagement with the inner surface of the body lumen. The device is reversibly interchangeable between a first folded configuration and a second deployed or open configuration. The device is preferably attached to the sleeve of a stent graft independent of the stents which are preferably ring stents. A stent graft comprising the device is also described.

Abstract: An endoluminal prosthesis includes a support structure including a curvilinear portion having a first strut and a second strut that meet at an apex. Disposed on the support structure is an anchor with an anchor body and one or more barbs extending outwardly from the anchor body. The anchor body can fit at least partially about, and can conform to the first strut, second strut, and the apex. A curved portion of the anchor and the curvilinear portion of the support structure can be co-formed, resulting in a secure interference fit so that welding, soldering, or other joining mechanisms can be avoided. Cutouts can be formed along the curved portion of the anchor to relieve stress or strain during the co-forming process.

Abstract: Apparatus for permanent placement across an ostium of a left atrial appendage in a patient, which includes a filtering membrane configured to extend across the ostium of the left atrial appendage. The filtering membrane has a permeable structure which allows blood to flow through but substantially inhibits thrombus from passing therethrough. The apparatus also includes a support structure attached to the filtering membrane which retains the filtering membrane in position across the ostium of the left atrial appendage by permanently engaging a portion of the interior wall of the left atrial appendage. The support structure may be radially expandable from a first configuration to a second configuration which engages the ostium or the interior wall of the left atrial appendage. The filtering membrane may define an opening therethrough that is configured to expand from a first size which inhibits the passage of thrombus therethrough to a second size which allows an interventional device, e.g.

Abstract: A vascular prosthesis comprising a tubular shaped expandable ECM member and at least one anchoring mechanism. In one embodiment, the anchoring mechanism comprises proximal and distal single or dual-ring anchors. In one embodiment, the anchoring mechanism comprises a multiple-ring anchor. The anchors preferably comprise a biodegradable metal, such as magnesium. The anchors can also comprise a shape memory alloy, such as nitinol, and a cross-linked ECM material. In some embodiments, the ECM member includes a pharmacological agent.

Abstract: An artificial blood vessel includes a flexible tube and a structure provided at one end portion of the tube and capable of being deformed to a first outside diameter and a second outside diameter greater than the first outside diameter, wherein the tube is provided with a lock part which is locked at a desired position when the tube is folded back from its other end portion to the inside.

Abstract: The present disclosure includes a securing device comprising one or more barbs. A barb may comprise a depth stop, which may itself comprise an apex portion coupled to a trough portion. A barb may be constructed, in various embodiments, from a length of shape memory wire. Thus, during deployment, a barb may spring away from a medical device to which the barb is coupled such that the barb makes contact with and punctures, to a limited depth, a body lumen wall. A barb may not, however, fully puncture a body lumen wall. Rather, a depth stop may limit a puncture depth to a depth that does not endanger and/or subject tissue surrounding or external to the lumen wall to damage and/or bleeding or leakage from within the lumen. In various embodiments, a pair of barbs may be coupled to from an integral two pronged barb.

Abstract: A medical stent comprising a coil formed by winding a wire around an axis, an outer layer formed substantially tubular made from a first resin material, provided on an outer peripheral side of said coil and coaxial to said coil, and an inner layer formed substantially tubular made from a second resin material, provided on an inner peripheral side of said coil and coaxial to said coil.

Abstract: A tubular prosthesis is radially deformable and includes a lattice that is deformable between a retracted state of small diameter and an expanded state of larger diameter. The prosthesis includes at least two outer hooks delimiting between them a clamp for engaging in an outer tissue. The two hooks are carried by the lattice and can be moved between a spaced-apart position in which the clamp is open and a closer-together position in which the clamp is closed. The prosthesis includes a guiding member for moving at least one of the hooks during deformation of the prosthesis. The guiding member delimits a guide passage in which at least one of the hooks is engaged.

Abstract: A stented valve including a stent structure having a generally tubular body portion, an interior area, a longitudinal axis, an first end, an second end, and an outer surface; at least one outflow barb extending from the outer surface of the stent adjacent to the first end of the stent structure and toward the second end of the stent structure; at least one inflow barb extending from the outer surface of the stent adjacent to the second end of the stent structure and toward the first end of the stent structure; and a valve structure attached within the interior area of the stent structure.

Abstract: An apparatus is provided in one example embodiment and includes a body section having an upper surface, a lower surface, and an inner edge circumferentially arranged around at least a portion of an open area. The apparatus also includes a tool extending from the body section into the open area for holding a graft vessel. The lower surface of the body section opposes a receiving vessel when the tool is positioned to transfer the graft vessel to the receiving vessel, such that the graft vessel is axially accessible through the open area to be attached to the receiving vessel. In more specific embodiments, the body section has first and second opposing ends defining a gap sized to permit the vessel to pass through.

Abstract: Disclosed herein is a stent for prostatic urethra expansion which does not generate bladder stones, is removable without causing injury on a urethra, and does not generate atrophy of a prostatic urethra even after removal. The stent for prostatic urethra expansion include a stent unit including a cylindrical body with space parts formed by knotting or crossing shape memory alloy wires and bending terminals formed at both ends of the cylindrical body, a pair of hook wires passing through the space parts and knotted to the shape memory alloy wires, both ends thereof being wound on the bending terminals and then being bent upwardly to produce hooks, and a pair of hanging strings arranged in opposite directions to form a hanging knot. The stent for prostatic urethra expansion does not move into the bladder, and expands and maintains a lumen of the stenosed prostatic urethra, thereby reducing post-operative recovery time.

Abstract: A stent graft for use in a medical procedure to treat a dissection of a patient's ascending thoracic aorta. The stent graft includes bare alignment stents at least at a proximal end, and often with a stent at both ends, each stent having opposing sets of curved apices, where the curved section of one broader set of apices has a radius of curvature that is greater than the curved section of the other narrower set of apices. The proximal stent is flared in a manner such that its broad apices occupy a larger circumference around the stent than do its narrower apices, where this flared feature provides for anchoring engagement near the aortic root in a manner not interfering with the coronary arteries or the aortic valve.

Abstract: A debranching visceral stent graft and methods for its use, where the stent graft comprises, a main body stent graft with a bifurcation defining a first leg and a second leg, the main body stent graft has a distal end and a proximal end, the main body stent graft's diameter at the proximal end ranges from about 18-22 mm, the first leg and the second leg each have a diameter that ranges from about 14-16 mm, the distance from the proximal end of the main body to the distal end of the first leg ranges from about 70-90 mm, the distance from the proximal end of the main body to the distal end of the second leg ranges from about 80-100 mm, and the second leg is at least about 10 mm longer than the first leg.

Abstract: A removable device such as a stent-graft, intended for applications where it may be desirable to remove the device at some time following implantation. The stent-graft of the present invention includes a helically-wound stent component provided with a covering of graft material. It is removable by gripping an end of the helically-wound stent component with a retrieval device and applying tension to the stent component in the direction in which it is intended to be withdrawn from the site of implantation. The use of such a retrieval device allows the stent-graft to be removed remotely, such as via a catheter inserted into the body at a different location from the implantation site. The design of the stent-graft is such that the stent component is extended axially while the adjacent portion of the graft separates between windings of the stent component.

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: Stents or scaffolds made from magnesium or magnesium alloys including additives or barrier coatings that modify the corrosion rate of the stent are disclosed. Methods of forming barrier coatings that modify the corrosion rate of the stent are disclosed.

Abstract: The present invention provides compositions and methods for shielding and directing agents to biological targets in cellular systems for therapeutic, prophylactic, and diagnostic uses. Vascular devices are also provided which have coated surfaces that contain proteomic antisense, as well as therapeutic and other biological agents attached thereto.