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.

Abstract: The present invention is directed at a removable stent for providing reinforcement to a selected region of a selected body lumen including a resilient cylindrical layer, including at least one bioresorbable extrusion exterior from the resilient cylindrical layer for resisting migration of the removable stent when the removable stent is positioned in the selected region of the selected body lumen. The present invention also includes a temporary implantable endoprosthesis which includes a tubular, radially compressible and axially flexible structure, including at least one bioresorbable extrusion exterior from the resilient cylindrical layer for resisting migration of the removable stent when the removable stent is positioned in the selected region of the selected body lumen.

Abstract: A method and system for providing detecting and classifying coronary stenoses in 3D CT image data is disclosed. Centerlines of coronary vessels are extracted from the CT image data. Non-vessel regions are detected and removed from the coronary vessel centerlines. The cross-section area of the lumen is estimated based on the coronary vessel centerlines using a trained regression function. Stenosis candidates are detected in the coronary vessels based on the estimated lumen cross-section area, and the significant stenosis candidates are automatically classified as calcified, non-calcified, or mixed.

Abstract: To provide a biological adhesive sheet which is reduced in the influence on living tissue and thus has improved safety. A biological adhesive sheet includes a substrate formed of a biocompatible material; and a plurality of projections that are formed of a biocompatible material and configured so as to protrude from the surface of the substrate. The biological adhesive sheet is bonded to living tissues by the van der Waals force by having the plurality of projections in contact with the living tissues.

Abstract: An aortic stent-graft may include a tubular graft extending from a proximal end to a distal end, the graft comprising a proximal sealing portion and an intermediate portion, wherein a proximal end of the intermediate portion abuts the distal end of the proximal sealing portion. At least one sealing stent may be attached to the proximal sealing portion. A first fenestration window is disposed in the intermediate portion. The first fenestration window has a length determined by the equation L=1.23*D?24 millimeters, where L is the length of the first fenestration window. D is between about 24 millimeters and 45 millimeters.

Abstract: Medical devices for implantation in a body vessel, and methods of using and making the same, are provided. A medical device can include a frame with one or more projections, each of which can be covered with a biocompatible, water-soluble removable material. The projections can be barbs positioned to engage the interior wall of a body vessel or to attach a material, such as a valve leaflet or graft, to the frame. The removable material can be dissolved within a body vessel upon implantation to expose the covered projection. Methods of making an implantable medical device and methods of treating a subject are also disclosed.

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: Expandable sealing means for endoluminal devices have been developed for controlled activation. The devices have the benefits of a low profile mechanism (for both self-expanding and balloon-expanding prostheses), contained, not open, release of the material, active conformation to the “leak sites” such that leakage areas are filled without disrupting the physical and functional integrity of the prosthesis, and on-demand, controlled activation, that may not be pressure activated.

Abstract: The invention relates a sheath that is affixed to a body lumen, proximal to an anastomosis site. The sheath includes a sleeve defining a passage. A grasping structure is positioned distally of the distal opening of the sheath to facilitate elongation of the sleeve from a first length to a second longer length. A method for using the sheath is also disclosed.

Abstract: A low profile support frame for use as an or in an expandable intraluminal medical device includes first and second wire members that define arcuate paths having opposing curves. Connectors join the wire members, and barbs can be disposed on the connectors. The support frame has radially compressed and radially expanded configurations. When the support frame is in the radially expanded configuration, substantially no portion of the support frame is disposed on a first transverse axis of the frame opposite one end of the frame and substantially no portion of the frame is disposed on a second transverse axis of the frame opposite the other end of the frame. The support frame can be used as an intraluminal medical device by itself or as a component in a medical device that includes other components, such as a stent, prosthetic valve, occluder, or filter.

Abstract: A stent for implantation in a body lumen for protecting from rupture a fibrous cap in order to treat vulnerable plaque. One embodiment of the stent achieves staged expansion through stronger and weaker circumferential regions, and includes optional anchors positioned at the circumferential transition between the stronger and weaker regions. During the first stage expansion, the weaker region expands moving the anchors laterally apart. The anchors straddle the fibrous cap and embed into the vessel wall. The second stage expansion of the stent exerts gentler stresses by the weaker region against the fibrous cap while the stronger region exerts greater stresses on the remainder of the vessel wall to open the vessel.

Abstract: A method is provided, including implanting at least a first tissue-engaging element in a first portion of tissue in a vicinity of a heart valve of a patient, implanting at least a second tissue-engaging element in a portion of a blood vessel that is in contact with an atrium of a heart of the patient, and drawing at least a first leaflet of the valve toward at least a second leaflet of the valve by adjusting a distance between the portion of the blood vessel and the first portion of tissue in the vicinity of the heart valve of the patient. Other applications are also described.

Abstract: Implantable splinting devices for supporting a passageway defect in a patient that is formed from one or more support structures comprising a polymer or a polymer and acellularized tissue matrix that define a structural component that substantially conforms to a defective passageway of the patient. The structural component also has a plurality of pores. The implantable splinting device is capable of being placed around a trachea, a bronchi, an esophagus and a blood vessel of a patient. The implantable splinting device may also be configured for placement between the trachea and the esophagus of a patient.

Abstract: An implant centering system includes a sensor connected to a hollow cylindrical anchor via at least two struts. The hollow cylindrical anchor is transformable between a radially compressed configuration for delivery and a radially expanded configuration for lodging against a vessel wall. The struts longitudinally relocate the sensor between a first position in which the sensor is longitudinally spaced apart from the radially compressed anchor, and a second position in which the sensor is at least partially within a lumen of the radially expanded anchor and radially centered within vessel. In one embodiment, the struts are heat-set into a curved configuration and an externally applied force longitudinally relocates the sensor until the struts lock over center into their heat-set configuration. In another embodiment, radial expansion of the anchor longitudinally relocates the sensor without an externally applied force.

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

Abstract: A stent-graft delivery system includes a stent-graft including a proximal anchor stent ring. The proximal anchor stent ring includes proximal apexes and anchor pin structures extending proximally from each of the proximal apexes. The anchor pin structures include anchor pin connecting arms and anchor pins. The anchor pin structures are tucked together to accommodate small catheter sizes. Further, the anchor pins reduce or eliminate migration of the stent-graft. Further still, the anchor pin connecting arms are long and flexible thus distributing stresses in a way that improves the load carrying capacity of the anchor pins and allows flowering of the graft material of the stent-graft prior to release of the anchor pins structures.

Abstract: The present invention is directed at a removable stent for providing reinforcement to a selected region of a selected body lumen including a resilient cylindrical layer, including at least one bioresorbable extrusion exterior from the resilient cylindrical layer for resisting migration of the removable stent when the removable stent is positioned in the selected region of the selected body lumen. The present invention also includes a temporary implantable endoprosthesis which includes a tubular, radially compressible and axially flexible structure, including at least one bioresorbable extrusion exterior from the resilient cylindrical layer for resisting migration of the removable stent when the removable stent is positioned in the selected region of the selected body lumen.

Abstract: A device includes a balloon and an interface. The balloon has an outer surface and a central lumen aligned on a longitudinal axis. The balloon is configured to receive a compressible fluid. The interface is coupled to the outer surface and has an external surface configured to bond with a tissue.

Abstract: An implantable medical device includes a frame that includes at least one elongate member. The implantable medical device also includes a fixation member comprising 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 comprising an arcuate shape and 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: 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 fits at least partially about, and conforms to the first strut, second strut, and the apex.

Abstract: A stent is provided for an endoprosthesis having a main body portion and two leg portions, particularly suitable for treatment of an abdominal aortic aneurism. The stent includes barbs that are twisted and shaped set to point radially outward. Each barb, as formed, points substantially perpendicular relative to the longitudinal axis of the stent, even when in a non-deployed configuration. The motion to move the barb into a deployed configuration for gripping tissue is a twisting motion which moves the barb from being substantially aligned with the circumference of the stent to extending radially outwards from the stent.

Abstract: A stent is provided for an endoprosthesis having a main body portion and two leg portions, particularly suitable for treatment of an abdominal aortic aneurism. The stent includes barbs that are twisted and shaped set to point radially outward. Each barb, as formed, points substantially perpendicular relative to the longitudinal axis of the stent, even when in a non-deployed configuration. The motion to move the barb into a deployed configuration for gripping tissue is a twisting motion which moves the barb from being substantially aligned with the circumference of the stent to extending radially outwards from the stent.

Abstract: A stent is provided for an endoprosthesis having a main body portion and two leg portions, particularly suitable for treatment of an abdominal aortic aneurism. The stent includes barbs that are twisted and shaped set to point radially outward. Each barb, as formed, points substantially perpendicular relative to the longitudinal axis of the stent, even when in a non-deployed configuration. The motion to move the barb into a deployed configuration for gripping tissue is a twisting motion which moves the barb from being substantially aligned with the circumference of the stent to extending radially outwards from the stent.

Abstract: A docking head of the present invention is provided to be mounted on a vascular graft having an outer diameter comparable with the inner diameter of the blood vessel so as to couple the vascular graft to a vessel wall in a suture-less manner. The docking head comprises a thin-walled hollow truncated cone having a passage sized to fit the outer diameter of the vascular graft wherein the cone is capable of connecting to the vascular graft while the hollow thin-walled truncated cone is provided with a plurality of outwardly pointing and inclined plurality of barbs. The docking head act as guiding, anchoring and sealing means between the vascular graft and the vessel.

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 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: The disclosure relates to an implantable woven graft for bridging a defect in a main vessel near one or more branch vessels. The graft includes a region of reduced density. Reduced density regions are alignable with at least one of the one or more branch vessels, and are suitable for in situ fenestration, for example by perforation. The disclosed examples are particularly suited for bridging abdominal aortic aneurysms.

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

Abstract: The present invention embodies an endovascular graft having an attachment frame connection mechanism that allows placement of the main body component in vasculature in combination with limb components. Various limb component-to-main body component attachment mechanisms are provided which ensure a reliable bond while facilitating a smaller delivery profile.

Abstract: Embodiments of a medical device and related methods of use are provided in the disclosure. The medical device includes an elongate member having a first end defining a first opening, a second end defining a second opening, and a tapered lumen extending between the first and second openings. The diameter of the first end may be smaller than that of the second end. The medical device also may include a securing mechanism protruding from one of the first or second ends to penetrate tissue.

Abstract: A stent is provided for an endoprosthesis having a main body portion and two leg portions, particularly suitable for treatment of an abdominal aortic aneurism. The stent includes barbs that are twisted and shaped set to point radially outward. Each barb, as formed, points substantially perpendicular relative to the longitudinal axis of the stent, even when in a non-deployed configuration. The motion to move the barb into a deployed configuration for gripping tissue is a twisting motion which moves the barb from being substantially aligned with the circumference of the stent to extending radially outwards from the stent.

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

Abstract: 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: A vascular connector includes a main tube having a channel for fluid flow therethrough and opposed ends adapted to be connected to a vascular structure; and at least one inlet tube having a channel for fluid flow therethrough, a proximal end intersecting the main tube, and a distal end adapted to be connected to a vascular structure.

Abstract: An endoluminal prosthesis including a radially expandable frame and an anchoring member. The anchoring member includes a first arm attached to a first strut of the frame and a second arm attached to a second adjacent strut of the frame. The first arm is joined to the second arm to form a vessel engaging end that, together with at least a portion of the first arm and second arm, is directed toward a central axis of the frame in the frame's collapsed configuration.

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: A scaffold is provided for managing access through tissue. The scaffold can support the tissue during medical procedures. The scaffold is placed around or proximate an opening in tissue. The scaffold can expand when medical devices are introduced through the scaffold and through the opening and retract when the medical devices are removed. When the medical devices are removed, the scaffold closes automatically to substantially close the opening.

Abstract: Described herein are implantable medical devices comprising a biocompatible polymer comprising a triggerable bioadhesive property that allows the device to adhere to body tissue. The triggerable bioadhesive property of the polymer can be triggered or activated by exposure to a stimulus. Also, the present invention pertains to methods of making an implantable medical device comprising a biocompatible polymer comprising a triggerable bioadhesive property that allows the device to adhere to body tissue.

Abstract: An endoluminal prosthesis is described and comprises a stent (40), At least one barb (42) secured to the stent, and a degradable barb guard (52) covering at least a portion of the barb and protecting the distal tip when the stent is in a compressed configuration. The barb guard (52) comprises a degradable structure that degrades to expose the distal tip of the barb when the stent is placed in a vessel.

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: The present invention provides a system and a method for forming in vivo a junction between a first and a second element of a modular endovascular prosthesis used for repairing defects in vessels and other lumens within the body of a patient. The first element is adapted to have a receiving element, and the second element is adapted to have a protruding element. In the final deployed configuration of the endovascular prosthesis, the protruding element of the second element is adapted to be engaged with the receiving element of the first element, substantially preventing axial separation of the elements relative to each other. The receiving element of the invention may have various forms, and may include a fold in the wall of the first element, an expandable framework having protruding struts, or a flexible thread.

Abstract: A valve stent includes a plurality of crown elements arranged coaxially one behind the other, each formed by several u-shaped bends with at least one base and two ends. The bases of one crown element are connected to the ends of another crown element via connection bars. To produce this valve stent, 3D droplet dosing technology is used to form a thin-walled sandwich structure. A device, suitable for application of a stent is provided with positioning wires having clamps at their ends which can be connected to the fixing hooks at the ends of the crown elements in force-locking manner.

Abstract: The present embodiments provide a stent for use in a medical procedure that comprises a series of proximal apices disposed at a proximal end of the stent and a series of distal apices disposed at a distal end of the stent. A trigger wire is adapted to be coupled to at least one of the proximal apices to restrain a proximal end of the stent during delivery. In a first embodiment, a first proximal apex comprises a bore for receiving the trigger wire, and a second proximal apex, disposed adjacent to the first proximal apex, comprises at least one barb. The trigger wire therefore is only coupled to selected ones of the proximal apices. In an alternative embodiment, a first proximal apex comprises a first bore and a second, adjacent proximal apex comprises a second bore, such that a single trigger wire may be disposed through the first and second bores to restrain the first and second proximal apices during delivery.

Abstract: A multi-sided intraluminal medical device having a self-expanding frame and a pair of guide bars located on opposite ends of the frame and adapted to enable the frame to be retracted for delivery or retrieval from either end is provided. The intraluminal device may further include a partial or full covering that is circumferentially attached to the frame. Such a medical device may be used as a stent to maintain an open lumen in a vessel (e.g., a vein, artery, or duct), as a valve, or as an occlusion device.

Abstract: A tack device for holding plaque against blood vessel walls in treating atherosclerotic occlusive disease can be formed as a thin, annular band of durable, flexible material. The tack device may also have a plurality of barbs or anchoring points on its outer annular periphery. The annular band can have a length in the axial direction of the blood vessel walls that is about equal to or less than its diameter as installed in the blood vessel. A preferred method is to perform angioplasty with a drug eluting balloon as a first step, and if there is any dissection to the blood vessel caused by the balloon angioplasty, one or more tack devices may be installed to tack down the dissected area of the blood vessel surface, in order to avoid the need to install a stent and thereby maintain a ‘stent-free’ environment.

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 implantable endoluminal prosthesis for replacing a damaged aortic valve is provided. In one embodiment, the prosthesis includes a balloon-expandable stent, a tubular conduit that extends into the ascending aorta, and a self-expanding stent. The tubular conduit extends across the balloon-expandable stent. The tubular conduit includes an artificial valve. The self-expanding stent extends across the tubular conduit into the ascending aorta. The balloon-expandable stent, the tubular conduit, and the self-expanding stent are coupled to provide unidirectional flow of fluid into the aorta and further into the coronary arteries. Also provided is a method for implanting the endoluminal prosthesis.

Abstract: Suturing elements for connecting a vascular prosthesis to a blood vessel include an internal, substantially annular body intended to be received in the blood vessel in addition to an external annular body intended to lie clampingly on an outer wall of the blood vessel at least practically at the location of the internal annular body. At least one of the two annular bodies is provided with suturing members which grip in the vessel wall so as to effect an adequate fixation of at least the internal annular body. The device for use with such suturing elements and a vascular prosthesis which is provided on at least one of its outer ends with at least a part of such suturing elements are disclosed. Different embodiments of such prostheses together form a modular vascular prosthesis system. A side vessel of a thus supported blood vessel can be preserved using branch elements.

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 tubular implant having an axial end to which is attached a ring of spoons of a material different from that of the implant. In another aspect, the invention provides a method of attaching elements to an axial end of a tubular implant comprising the steps of providing said elements on one end of a support tube having a radius substantially that of the implant in its unexpanded configuration, abutting the implant and elements end-to-end, fixing the elements to the implant; and parting the elements from the support tube. In a third aspect, the invention provides an implant carrying an element of another material, the element and implant having complementary tapered mating surfaces for achieving a taper form fit of the element onto the implant.