Abstract: A medical device having a coating of biologic macromolecules. The coating of biologic macromolecules is protected by a temporary protective layer disposed over the biologic macromolecules. The temporary protective layer serves to protect the structure (e.g., conformation) and/or function (e.g., target binding capacity) of the biologic macromolecules during processing, storage, handling, and/or delivery (e.g., implantation or insertion into a patient) of the medical device. Upon implantation or insertion into a patient's body, the temporary protective layer may dissolve to expose the biologic macromolecules to the physiologic environment.

Abstract: An improved hood provides for the attaching of endoluminal prosthesis within corporeal lumens. The hook is integrally formed with framing structure and is preset into an outward bend, but is resiliently flexible so as to form a substantially straight profile when compressed. The hook is capable of impinging upon the corporeal lumen and thereby securing the prosthesis. The hook may be configured for intraluminal delivery and deployment. A novel method of manufacturing said hook is also provided.

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: 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: A stent anastomosis comprises a stent segment reconfigurable between a deployment configuration and a shortened, transversely expanded deployed configuration having a transverse dimension larger than its longitudinal dimension. In the deployed configuration, the stent segment engages an inner surface of an intravascular graft, securing the end of the graft within a vessel and forming a seal between the graft and an endoluminal surface of the vessel. The stent segment includes at least one securing member that extends outward from the stent segment in the deployed configuration, that pierces and penetrates the graft, and that pierces the endoluminal surface of the vessel to secure the graft within the vessel. In the deployed configuration, the stent segment can compress the graft against the endoluminal surface of the vessel to form the seal.

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: A device for treatment of mitral annulus dilatation comprises an elongate body having two states. In a first of these states the elongate body is insertable into the coronary sinus and has a shape adapting to the shape of the coronary sinus. When positioned in the coronary sinus, the elongate body is transferable to the second state assuming a reduced radius of curvature, whereby the radius of curvature of the coronary sinus and the radius of curvature as well as the circumference of the mitral annulus is reduced.

Abstract: The present invention embodies an endovascular graft having various frame-to-main body component attachment mechanisms which provide a secured bond, reduced graft material wear, and reduced delivery profile.

Abstract: Percutaneous methods of forming a venous valve from autologous tissue are disclosed. The methods include percutaneously creating one or two subintimal dissections for forming one or two flaps of intimal tissue. In one method, a puncture element is delivered by a catheter based delivery system to a treatment site where a new venous valve is to be created. The puncture element is deployed to gain access to a subintimal layer of the vein wall. A dilation balloon is than positioned and inflated within the subintimal layer to create a flap and corresponding pocket/sinus in the vein, which than acts as a one-way monocuspid valve in the manner of a native venous valve. In a similar manner, methods of forming new bicuspid venous valves by subintimal dissections are also disclosed.

Abstract: An implantable valvular prosthesis is adapted for replacement of an anatomic valve that controls passage of blood flowing from an atrium to a ventricle in a patient's heart. The implantable valvular prosthesis includes a tubular stent body, at least one valve flap member, and a graft member. The tubular stent body includes a tubular trailing region and a tubular leading region. The valve flap member is disposed to associate with the tubular stent body. The graft member covers an abluminal surface of the tubular stent body.

Abstract: An improved hook provides for the attaching of endoluminal prosthesis within corporeal lumens. The hook is integrally formed with framing structure and is preset into an outward bend, but is resiliently flexible so as to form a substantially straight profile when compressed. The hook is capable of impinging upon the corporeal lumen and thereby securing the prosthesis. The hook may be configured for intraluminal delivery and deployment. A novel method of manufacturing said hook is also provided.

Abstract: The invention relates to a method for loading structured surfaces that are preferably made of a polymer material with the pharmacological agent paclitaxel as well as the coated medical products obtained by means of said method.

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: A vascular prosthesis comprising a hollow, tubular body (10) having suturing means (20..22) on at least a first outer end for suturing the body to a vessel wall of a bodily vessel of a user. The suturing means comprise a suturing ring (20), from which at least one suturing member (21) extends radially in order to penetrate the vessel wall. On at least the first outer end the tubular body (10) is double-walled, with an inner wall (11) and an outer wall (12) between which the suturing ring (20) lies enclosed. The suturing ring preferably comprises three such suturing members (21) and a closing ring (40) is arranged locally round the vessel.

Abstract: An anastomotic device includes a tube and anastomotic coupler rings having vessel openings attached to each end of the tube. In an embodiment, the diameters of the vessel openings are different.

Abstract: An anastomotic device includes a tube and anastomotic coupler rings having vessel openings attached to each end of the tube. In an embodiment, the diameters of the vessel openings are the same.

Abstract: An anastomotic device has a tube with three or more tube portions that are connected together. A first anastomotic coupler ring is attached to a first tube portion. A second anastomotic coupler ring is attached to a second tube portion. In an embodiment, a third anastomotic coupler ring is attached to a third tube portion.

Abstract: An apparatus for heating and setting elements of a stent. The apparatus is a mandrel having a central core cylinder with an outer surface including a plurality of raised forms and gaps in-between the raised forms. The mandrel also includes a first and second outer cylinder, each having a curved radial end with a cut-out design similar to the shape of the plurality of raised forms. Once a stent is placed on the central core cylinder, the first and second outer cylinders are positioned on the central core cylinder such that the curved radial ends of the first and second outer cylinders align with the plurality of raised forms, shaping the stent.

Abstract: The present invention embodies an endovascular graft having various frame-to-main body component attachment mechanisms which provide a secure bond, reduced graft material wear, and reduced delivery profile.

Abstract: A method and apparatus for anchoring a medical implant device after the device has been brought to rest at a desired position within a blood vessel or other body passageway. An anchor delivery system is provided which houses one or more uniquely configured expandable anchors which are connected to the medical implant device. The anchors remain housed in a non expanded configuration until after the medical implant device has come to rest in a desired position within the body, and then the anchors are positively propelled through a body wall from a first side to a second side where each anchor expands outwardly from an anchor shaft. In one configuration, the anchors are each formed in the shape of a compressible closed loop which extends outwardly from an anchor shaft and loops back to cross over and extend beyond the anchor shaft.

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: An valve prosthesis, such as an artificial venous valve, having a support frame and leaf structure comprising one or more leaflets in which the outer edge of each leaflet engages the inner circumference of the bodily passageway along a serpentine path urged against the passageway by an expandable frame, while the inner edges move in response to fluid to restrict retrograde flow. Optionally, one or more elements can extend from the support frame/leaf structure to provide centering support and/or protection from the leaflet adhering to the vessel wall. In one embodiment, the centering support structure comprises a second or third expandable frames attached to and extending from the proximal and/or distal ends of main valve structure and support frame. In another embodiment, one or more support elements extend outward from the valve support frame to engage the vessel wall to provide greater longitudinal stability.

Abstract: An intraluminal system for retrieving an implantable medical device from a body vessel includes, according to one embodiment, a grasping component including at least one deployable arm, where a proximal end of the arm is configured to extend away from a longitudinal axis of the system when deployed, and a first sheath disposed adjacent to the grasping component, where the first sheath includes a radially expandable portion at a distal end thereof. A second sheath overlies the first sheath and the grasping component. Relative motion between the second sheath and the grasping component allows the proximal end of the deployable arm to be deployed for grasping a distal portion of an implantable medical device, and relative motion between the second sheath and the first sheath allows the expandable portion of the first sheath to radially expand to receive a proximal portion of the implantable medical device.

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: A system for making anastomoses between hollow structures by mechanical means is provided with a device in the shape of an annular or tubular element comprising circumferentially provided means, such as pin-shaped elements, for joining the abutting walls of the hollow structures together. An applicator is intended for moving said annular or tubular element in position and activating the joining means thereof, so as to make the anastomosis. Possibly, intraluminal joining means can be inserted without using an annular or tubular element.

Abstract: The technology described herein generally relates to the field of tissue engineering and treatment of cardiovascular disease by endovascular repair. The technology more particularly relates to devices and methods to produce a tissue-based implant that can be used for abdominal aorta aneurysm, thoracic aorta aneurysm, or other cardiovascular repair.

Abstract: A total aortic arch reconstruction graft, including a) a first, hollow cylindrical segment in the shape of an aortic arch and adapted to be joined to a patient's ascending aorta, and including three side hollow cylindrical branches in communication therewith and adapted to be joined to a patient's left subclavian artery, left common carotid artery and innominate artery, respectively, and a fourth hollow cylindrical branch adapted to be joined to a heart-lung machine; b) a second, hollow cylindrical segment having a first end being 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 open-mesh stent having means for attaching the second segment to an internal surface of a patient's descending aorta, c) a collar having a diameter slightly larger than the diameter of said first segment, the collar located at a juncture where the first end of the second segment

Abstract: Implantable medical devices comprising a support frame and a graft member attached to the support frame. The support frame can define one or more structural features that substantially prevent migration of the graft member along the support frame.

Abstract: An aneurysmal repair system that utilizes a modified apex and delivery device is designed for accurate endoprosthesis delivery and deployment. The modified apex utilizes segments that overlap and hold one another down as well as the fixation barbs attached thereto. The delivery device holds or secures at least one section of the apex and may be easily released by retraction of a hold down member.

Abstract: Disclosed is an anchoring element for an implantable prosthesis that includes a barb, wherein the anchoring element, which includes a basal portion, comprises a thin layer of material, such as a cannula or sheet of metal, that extends or wraps at least partially around the strut of the prosthesis to which it is attached. The barb is configured to extend outward from the basal portion to penetrate adjacent tissue. The anchoring element is either permanently affixed to the strut, such as by laser or spot welding, crimping, or some other method of bonding, or allowed to slide longitudinally over the strut between two points or stops in order to relieve any excessive loads placed upon the barb that could cause fracture. The anchoring element and strut may be configured to limit axial rotation of the barb, while still allowing longitudinal movement. In another embodiment, the slidable anchoring element may be manipulated following initial deployment to reorient the barb toward the implantation site.

Abstract: An endovascular prosthesis has a prosthesis body that is sized and configured for introduction into a blood vessel lumen. The prosthesis body has a wall that defines an interior passage for blood. One or more connectors are distributed about the wall. A fastener is carried by at least one of the connectors. The fastener is sized and configured for advancement through the connector into tissue in the blood vessel lumen.

Abstract: The invention relates to an implantable device for local release of at least one drug at a predefined location in a natural cavity having a wall in the body of a mammal, characterized by at least one drug reservoirs, which can be affixed in the cavity, the drug reservoirs and/or a drug outlet being arranged at a distance from the wall, such that the at least one drug is released at a distance from the wall.

Abstract: A device (10) for maintaining fluid flow through at least one passage in a human or animal body, the device comprising two end portions (12, 14) for anchoring the device in position, and an intermediate portion (16) which allows movement of the end portions relative to each another, wherein the end portions and intermediate portion together define a pathway for fluid flow through the device. The device is particularly suitable for use in the treatment of coronary heart disease by minimally invasive surgery, and the invention extends to a method for diverting fluid flow from one passage to another.

Abstract: A prosthetic device is provided that is used in end-to-side, end-to-end, and side-to-side anastomosis without clamping and sutureless, or with expeditious clamping and sutureless, wide, single or multiple, at the same time, without the risk of kinking, where the graft is inserted in at least one of the intraluminal portions of the prosthesis tubular member. The tubular member is flangeless and comprises double holes or small external handles in its extension where wires pass to fix the prosthesis to the organ walls and/or the grafts to prosthesis.

Abstract: An endoluminal prosthesis including a tubular graft having a proximal end and a distal end; a suprarenal spring stent operably connected to the proximal end, the suprarenal spring stent having suprarenal positive apices and suprarenal negative apices connected in a sinusoidal ring pattern by suprarenal struts; and a sealing spring stent operably connected to the tubular graft, the sealing spring stent having sealing positive apices, sealing negative apices, and intermediate sealing negative apices connected in a ring pattern, the sealing negative apices alternating with the intermediate sealing negative apices between adjacent sealing positive apices, the sealing positive apices being connected to the sealing negative apices by sealing struts, and the sealing positive apices being connected to the intermediate sealing negative apices by intermediate sealing struts. The suprarenal positive apices are axially aligned with the intermediate sealing negative apices.

Abstract: A fixation band for affixing a prosthetic heart valve to tissue having proximal and distal annular portions positionable relative to one another, the proximal and distal annular portions each having a proximal and distal sides, the proximal side of the distal annular portion and the distal side of the proximal annular portion being oriented toward one another, and a prosthetic heart valve being attachable to one of the distal side of the distal annular portion and the proximal side of the proximal annular portion; staples configured between the distal side of the proximal annular portion and the proximal side of the distal annular portion; and a compression device operative between the proximal and distal annular portions for selectively positioning the proximal and distal annular members toward one another for compressing the staples therebetween and deploying the staples into tissue so as to affix the prosthetic heart valve to tissue.

Abstract: A stent fixation system 3 for fixation of a stent, comprising two retaining areas 10 which are connected by a connecting area 12 to form a fixation tubing. The retaining areas 10 provide a retaining structure which is designed to hold at least one stent strut 2 of the stent in the undilated state, such that the stent struts 2 are no longer in one of the retaining areas 10, at least in the dilated state of the stent.

Abstract: A stent graft fixation system and method of use includes a stent graft system for fixation to a vessel wall, the system having a helical anchor and a stent graft. The helical anchor has a number of coils with a point at one end and a helical anchor axis, and the stent graft has a stent graft axis. The coils are operable to sew the stent graft to the vessel wall with the helical anchor axis generally parallel to the stent graft axis.

Abstract: An endoluminal prosthesis for use in the ascending aorta is disclosed. The prosthesis includes a tubular graft material having an outer surface and an inner surface, a support structure coupled to the graft material, and a plurality of anchors extending from a proximal end of the support structure. Each anchor is curved outwardly such that a middle portion of the anchor extends further outwardly than a proximal portion of the anchor and a distal portion of the anchor such that the anchors conform to the shape of the aortic root. A hook extends outwardly from a proximal end of each anchor to engage the annulus of the aortic valve. The proximal end of the support structure and graft material is disposed adjacent the sinotubular junction.

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: An aneurysmal repair system that utilizes a modified apex and delivery device is designed for accurate endoprosthesis delivery and deployment. The modified apex utilizes segments that overlap and hold one another down as well as the fixation barbs attached thereto. The delivery device holds or secures at least one section of the apex and may be easily released by retraction of a hold down member.

Abstract: A branch vessel suture stent system and method including a branch vessel suture stent having a stent body having a first end, a second end, and a central axis, the first end having a first periphery; and shape memory hooks disposed about the first periphery, each of the shape memory hooks being attached to the first periphery at an attachment point, the shape memory hooks being elongated in a stressed state and looped in a parent state, each of the shape memory hooks defining a loop plane in the parent state. The shape memory hooks are substantially parallel to the central axis in the stressed state, and the first periphery at the attachment point for each of the shape memory hooks is substantially orthogonal to the loop plane for each of the shape memory hooks in the parent state. The delivery system allows the main body of the branch device to expand while maintaining the hooks in an undeployed configuration using individual hypotubes.

Abstract: Disclosed herein are medical devices, such as intravascular stents, for delivering a therapeutic agent to the body tissue of a patient, and a method for making such medical devices. More particularly, the medical devices have a coating that includes a polymer that adheres to the surface of the medical device so that the coating is able to resist damage during loading, deployment and implantation.

Abstract: The disclosure relates to medical devices for implantation in a body vessel, and methods of using and making the same. A medical device can include a frame with one or more projections each having at least one edge extending from the surface of the frame, and a biocompatible, water-soluble removable material coated over at least a portion of the at least one edge. 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, thereby exposing the at least one edge. Methods of making an implantable medical device and methods of treating a subject are also disclosed.

Abstract: As described herein, vascular anchoring systems are used to position an implant in a vascular area such as a bifurcated vasculature with relatively high fluid flow, for instance, in an area of a pulmonary artery with associated left and right pulmonary arteries. Implementations include an anchoring trunk member having a first anchoring trunk section and a second anchoring trunk section. Further implementations include a first anchoring branch member extending from the anchoring trunk member. Still further implementations include a second anchoring branch member extending from the anchoring trunk member.

Abstract: As described herein, vascular anchoring systems are used to position an implant in a vascular area such as a bifurcated vasculature with relatively high fluid flow, for instance, in an area of a pulmonary artery with associated left and right pulmonary arteries. Implementations include an anchoring trunk member having a first anchoring trunk section and a second anchoring trunk section. Further implementations include a first anchoring branch member extending from the anchoring trunk member. Still further implementations include a second anchoring branch member extending from the anchoring trunk member.

Abstract: As described herein vascular anchoring systems are used to position an implant in a vascular area such as a bifurcated vasculature with relatively high fluid flow, for instance, in an area of a pulmonary artery with associated left and right pulmonary arteries. Implementations include an anchoring trunk member having a first anchoring trunk section and a second anchoring trunk section. Further implementations include a first anchoring branch member extending from the anchoring trunk member. Still further implementations include a second anchoring branch member extending from the anchoring trunk member.

Abstract: As described herein, vascular anchoring systems are used to position an implant in a vascular area such as a bifurcated vasculature with relatively high fluid flow, for instance, in an area of a pulmonary artery with associated left and right pulmonary arteries. Implementations include an anchoring trunk member having a first anchoring trunk section and a second anchoring trunk section. Further implementations include a first anchoring branch member extending from the anchoring trunk member. Still further implementations include a second anchoring branch member extending from the anchoring trunk member.

Abstract: As described herein vascular anchoring systems are used to position an implant in a vascular area such as a bifurcated vasculature with relatively high fluid flow, for instance, in an area of a pulmonary artery with associated left and right pulmonary arteries. Implementations include an anchoring trunk member having a first anchoring trunk section and a second anchoring trunk section. Further implementations include a first anchoring branch member extending from the anchoring trunk member. Still further implementations include a second anchoring branch member extending from the anchoring trunk member.

Abstract: As described herein, vascular anchoring systems are used to position an implant in a vascular area such as a bifurcated vasculature with relatively high fluid flow, for instance, in an area of a pulmonary artery with associated left and right pulmonary arteries. Implementations include an anchoring trunk member having a first anchoring trunk section and a second anchoring trunk section. Further implementations include a first anchoring branch member extending from the anchoring trunk member. Still further implementations include a second anchoring branch member extending from the anchoring trunk member.