Abstract: A stent for a vessel implanted in the vessel of the living body including a main body portion of the stent formed into a tube by a yarn formed of a biodegradable polymer exhibiting a shape memory function. The main body portion of the stent is shape-memorized to a size that can be inplanted in the vessel. The main body portion of the stent is implanted in the vessel of the living body as it is contracted in diameter by an external force, and is enlarged in diameter by being heated with the temperature of the living body. The main body portion of the stent is formed by winding a yarn formed of a biodegradable polymer in a tube form as the yarn is bent in a zigzag design. The main body portion of the stent is enlarged or contracted in diameter with the bends of the yarn as the displacing portions.

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 body tissue graft for use in a patient includes a frame structure made of a first elastic material, a covering of a second elastic material on the frame structure, the covering substantially filling openings in the frame structure, and a connector connected to the frame structure. Projections are secured to the connector structure. The projections facilitate attachment of the tubular graft in a patient by securing the graft to the body tissue with which the graft is employed. The connector selectively circumferentially expands and the projections selectively circumferentially expand. This may be done using an inflatable balloon to circumferentially expand the projections. A restraining member may be provided to restrain the projections in a cone shape so that an end of the graft may be used to open an aperture through a side wall of existing body organ tubing and a portion of the projections may enter the aperture.

Abstract: The present invention provides implant devices configured to become anchored within tissue so that they do not migrate despite experiencing aggressive migration forces applied by the highly dynamic movement of muscle tissue that surrounds them. Additionally, methods for placing the devices so that they remain securely anchored within the tissue are provided. The devices are comprised of a flexible body, preferably formed from a helical wound spring. In a preferred embodiment the spring is wound from a ribbon-like filament having series of barbs or ridges formed along the proximal facing edge of the wound ribbon. The ribbon-like filament may be etched from a flat sheet of material, having barbs formed along one edge. The filament may then be wrapped into a helical coil shape to take the form of an implant having barbs formed along the proximally facing edge of each coil to resist migration.

Abstract: An intraluminal grafting system having a delivery catheter comprising a flexible elongate tubular member having proximal and distal extremities and a capsule mounted on the distal extremity of the tubular member and including a graft disposed within the capsule. The graft is comprised of a tubular body configured to be secured to a blood vessel by a self expanding attachment system. The attachment system comprises a generally sinusoidal wire frame having apices which extend longitudinally outward from the end of the tubular body apices which are secured within the tubular body. Both the protruding apices and the base apices are formed with helices which bias the attachment system radially outward. The attachment system further includes a plurality of lumen piercing members that are oriented in a responsive relationship to the radially outward bias of the attachment system.

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

Abstract: A polymer composition for use in forming a stent is described. The composition includes a monomer of an aliphatic ester of acrylic acid which has a glass transition temperature less than 25° C. and a second monomer that copolymerizes with the first monomer and which has a glass transition temperature greater than 25° C. The components in the composition are mixed in amounts suitable to give a copolymer having a glass transition temperature less than 25° C., or in case of block copolymers, having at least one glass transition temperature less than 25° C. A stent including polymer members formed from the described composition is also disclosed.

Abstract: A composite supported vascular graft comprising Vascular Endothelial Growth Factor (VEGF) and/or Platelet Derived Growth Factor (PDGF) for enhanced site-specific angiogenesis and methods thereof are disclosed. At least one VEGF, PDGF or angiogenesis factor is incorporated into the composite vascular graft to facilitate enhanced angiogenesis so as the cells are stimulated to migrate to environments having higher concentration of growth factors and start mitosis.

Abstract: An endovascular prosthesis (10) includes a first end (16) a furcated second end (18), and an anchoring means (20). The first end has a longitudinally extending central lumen (32) and means (40) for laterally supporting the first end. The furcated second end (18) includes at least two branches (64) that extend from an intersection of the furcated second end. Each of the branches (64) includes a longitudinal support means (84) and a branch lumen (78) in fluid communication with the central lumen (32) of the first end (16). The anchoring means (20) secures the first end (18) within a vasculature.

Abstract: The present invention provides anchoring mechanisms for tissue implants. The anchors are integrated as part of the structure of the implant and serve to resist migration of the implant from highly dynamic muscle tissue such as the myocardium of the heart. In implant devices configured as a flexible coil, various attributes of the coil may be altered to increase the anchoring capability of the device. The flexibility of the device may be increased to resist migration by changing the coil filament thickness, pitch or filament material. Alternatively, the end coil may be altered to have a broader cross-sectional profile in engagement with the tissue or may include an anchoring barb. Additionally, methods of implanting a tissue implant device are provided.

Abstract: An intraluminal grafting system having a delivery catheter comprising a flexible elongate tubular member having proximal and distal extremities and a capsule mounted on the distal extremity of the tubular member and including a graft disposed within the capsule. The graft is comprised of a tubular body configured to be secured to a blood vessel by a self expanding attachment system. The attachment system comprises a generally sinusoidal wire frame having apices which extend longitudinally outward from the end of the tubular body apices which are secured within the tubular body. Both the protruding apices and the base apices are formed with helices which bias the attachment system radially outward. The attachment system further includes a plurality of lumen piercing members that are oriented in a responsive relationship to the radially outward bias of the attachment system.

Abstract: An prosthesis for the repair of thoractic or abdominal aortic aneurysms (AAA) and a method for utilizing the prosthesis. Furthermore, an arrangement and method is provided for the repair of aortic aneurysms incorporating a device for the placement of the prosthesis in the corporeal lumen or body vessel of a patient, and wherein the prosthesis comprises a graft facilitating the exclusion of the aneurysm, and also provides for anastomotic structure for the attachment of the prosthesis in a laparoscopic surgical procedure.

Abstract: An intraluminal grafting system includes a hollow graft which has a proximal staple positioned proximate its proximal end and a distal staple adapted proximate its distal end. The system includes a capsule for transporting the graft through the lumen and for positioning the proximal end of the graft upstream in a lumen which may be a blood vessel or artery. A tube is connected to the capsule and extends to exterior the vessel for manipulation by the user. A catheter is positioned within the tube to extend from the cavity and through the graft to exterior the body. The catheter has an inflatable membrane or balloon proximate the distal end thereof which is in communication via a channel with inflation and deflation means located exterior the vessel. With the inflatable membrane deflated, the capsule is positioned in the lumen and manipulated to a desired location. The inflatable membrane is manipulated by the rod away from the graft.

Abstract: The present invention provides for reinforced and drug eluting stent-grafts and related methods of implanting and manufacturing the stent-grafts. A stent-graft of the present invention may include a tubular stent, a biocompatible covering surrounding the stent, and a supporting collar coupled to the proximal end of the stent-graft. A drug agent may be applied to a textured external surface layer of the biocompatible covering, or alternatively to a space between the textured external surface layer and a smooth luminal surface layer of the biocompatible covering, and allowed to elute over time into a wall of a body lumen after the stent-graft is deployed. The collar of the stent-graft absorbs pressure exerted on the stent-graft by fluid flow within the body lumen in order to minimize potential damage to the stent-graft, and may also include barbs to further secure the stent-graft to the body lumen.

Abstract: A vascular device comprising a plurality of vessel engaging members and a valve. The device is movable from a collapsed insertion position having a first diameter to a second expanded position having a second diameter larger than the first diameter. The plurality of vessel engaging members extend outwardly from the device for securely engaging the internal wall of a vessel upon expansion of the device to the second expanded position, wherein the vessel engaging members pull the internal wall of the vessel radially inwardly upon movement of the device from the second expanded position toward a first expanded position having a third diameter greater than the first diameter and less than the second diameter. In the first expanded position the valve is movable between an open position to allow blood flow therethrough to a closed position to prevent blood flow.

Abstract: The present invention provides a catheter apparatus, an improved introducer system, and a methodology for creating a bypass on-demand between an unobstructed blood vessel such as the aorta and an obstructed blood vessel such as an obstructed coronary artery in-vivo using a prepared shape-memory alloy cuff and a graft segment in tandem as a shunt. The invention allows the placement and creation of single or multiple bypass grafts without use of a heart-lung machine and without need for stopping the heart of the patient during the coronary artery bypass surgery.

Abstract: An intraluminal grafting system includes a hollow graft which has a proximal staple positioned proximate its proximal end and a distal staple adapted proximate its distal end. The system includes a capsule for transporting the graft through the lumen and for positioning the proximal end of the graft upstream in a lumen which may be a blood vessel or artery. A tube is connected to the capsule and extends to exterior the vessel for manipulation by the user. A catheter is positioned within the tube to extend from the cavity and through the graft to exterior the body. The catheter has an inflatable membrane or balloon proximate the distal end thereof which is in communication via a channel with inflation and deflation means located exterior the vessel. With the inflatable membrane deflated, the capsule is positioned in the lumen and manipulated to a desired location. The inflatable membrane is manipulated by the rod away from the graft.

Abstract: A body tissue graft for use in a patient includes a frame structure made of a first elastic material, a covering of a second elastic material on the frame structure, the covering substantially filling openings in the frame structure, and a connector connected to the frame structure. Projections are secured to the connector structure. The projections facilitate attachment of the tubular graft in a patient by securing the graft to the body tissue with which the graft is employed. The connector selectively circumferentially expands and the projections selectively circumferentially expand. This may be done using an inflatable balloon to circumferentially expand the projections. A restraining member may be provided to restrain the projections in a cone shape so that an end of the graft may be used to open an aperture through a side wall of existing body organ tubing and a portion of the projections may enter the aperture.

Abstract: A vascular device movable from a collapsed insertion position having a first diameter to a first expanded position and further movable to a second expanded position having a second diameter larger than the first diameter. A plurality of vessel engaging members extend outwardly from the device for securing the internal wall of a vessel upon expansion of the device to the second expanded position. The vessel engaging members pull the internal wall of the vessel radially inwardly upon movement of the device from the second expanded position toward the first expanded position having a third diameter greater than the first diameter and less than the second diameter.

Abstract: A stent includes a first turn made of a wire having a unit length. The first turn is formed having a plurality of first straight sections connected to each other by a plurality of bending points along a circumferential plane and a plurality of valleys and peaks formed by the bending points. The stent further includes a first intersection turn made of a wire having a unit length, the first intersection turn is formed having a plurality of straight sections intersecting the first straight sections to form a plurality of meshes, the straight sections of the intersection turn formed by a plurality of peaks and valleys.

Abstract: An apparatus for helping improve operation of a heart valve includes a generally arcuate base and a buttress extending generally from at least a portion of the base. The apparatus can be deformable to facilitate its implantation. When the apparatus is when implanted at an annulus of a heart valve, the buttress thereof cooperates with one or more leaflets of the heart valve to help control blood flow relative to the apparatus and heart valve.

Abstract: Extruded, stretched, sintered tubular PTFE materials are produced which are suited for use in the medical field as liners and covers for expandable stents. The PTFE materials have an unusually low REC (Radial Expansion Coefficient) and RER (Radial Expansion Ratio).

Abstract: The invention relates to an anchoring system for heart valve prostheses which can be implanted by introduction via the aorta without any major surgical operation. With the heart valve prosthesis according to the invention it shall be achieved that this can be safely and quickly guided through the aorta toward the heart, and can be fixed there. With this, hook-shaped elements are secured to the commissures of the heart valve prosthesis the hooks of which are guided in an outward direction through the heart valve prosthesis material.

Abstract: The present invention relates to an apparatus (300) for delivering an endovascular prosthesis within a blood vessel. The apparatus (300) includes a sheath (302) having a first end (310), a second end (308), an inner lumen (316) for receiving an endovascular prosthesis, and an outer lumen (322) for receiving a guide wire. The inner lumen (316) extends along a central axis (313) between the first end (310) and the second end (308). The outer lumen (322) is radially spaced from the inner lumen (316) and extends along an outer axis (323) between the ends (308 and 310).

Abstract: An endovascular prosthesis (10) includes a first end (16) a furcated second end (18), and an anchoring means (20). The first end has a longitudinally extending central lumen (32) and means (40) for laterally supporting the first end. The furcated second end (18) includes at least two branches (64) that extend from an intersection of the furcated second end. Each of the branches (64) includes a longitudinal support means (84) and a branch lumen (78) in fluid communication with the central lumen (32) of the first end (16). The anchoring means (20) secures the first end (18) within a vasculature.

Abstract: An intraluminal graft includes a tubular graft body extending along a cylindrical axis, a plurality of wires spaced apart from each other and arranged to circumferentially reinforce said tubular graft body along a substantial portion of its length, and a body surface including an inner surface region and an outer surface region. The body surface defines a plurality of apertures extending from an exterior space to an interior space, and a first portion of a first wire is in the interior space while a second portion of the first wire is in the exterior space.

Abstract: An expandable stent prosthesis is disclosed in which the apices of the bends located at at least one end of the stent are individually twisted at an angle to the circumference of the stent to form a fan blade-like arrangement when viewed from that end. The fan blade-like arrangement allows the stent to expand from the compressed condition during deployment such that likelihood of a strut or bend of the stent become entangled with a barb or adjacent strut or bend, is reduced. In one embodiment of the invention, the fan blade-like arrangement results from plastically deforming the individual apices, while in another embodiment, the apices are twisted into the fan blade-like arrangement during the loading process, such as by use of a suture thread to pull the apices into alignment.

Abstract: ENDOVASCULAR PROSTHESIS WITH SUTURE HOLDER. Said prosthesis comprises prosthetic body (b) on the internal surfaces (2) of which a number of connectors (4) are distributed and attached that, on the one hand, connect respective semi-flexible cables (b) ending in external rotary control ends (9′), while, on the other hand, they are passed through by respective spiral sutures (6) controlled by said semi-flexible cables (b). Once prosthetic body (b) is expanded, its external surfaces (3) are in contact with vascular walls (1). With this arrangement, the rotary actuation of semi-flexible cables (c) permits penetration ends (6′) of spirals (6) to pass through vascular walls (5). This penetration continues until anchoring ends (7) of above-cited spirals (6) stop against bases (4′) of respective connectors (4). In this manner, a firm union is created between vascular channel (a) and prosthetic body (b).

Abstract: A method and apparatus for performing coronary artery bypass surgery establishes a channel leading directly from a chamber of a heart into a coronary artery with said channel retained open during both diastole and systole. The coronary artery bypass procedure may be performed with or without cardiopulmonary bypass.

Abstract: A biocompatible carrier and a composition for forming the carrier are disclosed. The carrier is made from an ethylene vinyl alcohol copolymer which can serve as a reservoir, allowing for the local delivery and sustained release of actinomycin D. The carrier can be formed from the ethylene vinyl alcohol, copolymer, a dimethylsulfoxide solvent, and actinomycin D. Alternatively, the carrier can be formed from an ethylene vinyl alcohol copolymer, a dimethylsulfoxide solvent, actinornycin D, and a wetting fluid. The carrier can serve as a coating for a prosthesis, for example a stent. The composition is applied to a surface of the prosthesis and essentially all of the dimethylsulfoxide solvent or dimethylsulfoxide solvent/wetting fluid is removed or allowed to evaporate to form the coating.

Abstract: The present invention is directed to an expandable stent which is relatively flexible along its longitudinal axis to facilitate delivery through tortuous body lumens, but which is stiff and stable enough radially in an expanded condition to maintain the patency of a body lumen such as an artery when implanted therein. The struts of the present invention have a specific trapezoidal, triangular or a reduced radii configuration projecting radially outward that functions to reduce the forces necessary to penetrate the vessel wall thereby minimizing trauma or damage imparted to the wall during deployment. In addition, this design feature of the present invention helps secure the expanded stent so that it does not move once it is implanted and furthermore, minimizes projections into the blood stream. The invention generally includes a plurality of radially expandable loop elements which are relatively independent in their ability to expand and to flex relative to one another.

Abstract: Connector structures are provided for attaching elongated flexible tubular grafts to the body organ tubing of a patient. The connector structures are formed from wire. A first set of connector wires may be disposed around the periphery of one end of an elongated flexible tubular graft. A second set can be disposed around the periphery of the elongated flexible tubular graft spaced sufficiently from the first set of connector wires to define a gap. The portion of body organ tubing to which the elongated flexible tubular graft is to be attached is received in the gap and engaged by the first and second sets of connector wires. The wires may be formed in the shape of loops. If desired, hooks may be provided on the ends of the wires. The wires may be curved to accommodate attachment of the graft to tubular body organ tubing. The wires may also be formed in annular shapes. The connector structures may be formed as stand-alone ring-shaped connectors.

Abstract: Novel intraluminal devices that include a plurality of engagement members to minimize graft migration and vessel wall damage are described. Applications of the instant teachings for AAA and TAA issues wherein proximal neck attachments are critical are featured, in addition to general usages with stenotic disease. Further, an enhanced engagement member is described for preventing the migration of a prosthetic device through a body lumen.

Abstract: An implantable intraluminal prosthesis assembly is provided for use in repairing or replacing damaged or diseased portions of a blood vessel or other like vessel. The prosthesis includes an expandable stent/graft combination, with a pair of stents at either end of the graft, and further includes a plurality of struts extending between and interconnecting the stents, and radial spaced about the inner surface of the graft. As such, the implantable prosthesis is provided with internal support for the graft when in a compressed state during implantation and is further provided with radial support along the length of the graft after implantation.

Abstract: The invention consists of an endoluminal prosthesis adapted for placement at a bifurcation site within the body. The stent or stent-graft may be constructed to have segments of differing structural properties. A section of the stent-graft may be constructed to have a single-lumen tubular stent member covering a multilumen graft member. The stent-graft may comprise at least two modular components adapted for in situ assembly. An extended cylindrical interference fit may be used to seal the modular components.

Abstract: A coronary stent with one or more side ports that pierce the arterial wall to provide direct blood flow to the adjacent myocardium while simultaneously supporting the stented artery.

Abstract: An encapsulated stent having a stent or structural support layer sandwiched between two biocompatible flexible layers. One preferred embodiment has a stent cover which includes a tubular shaped stent that is concentrically retained between two tubular shaped grafts comprised of expanded polytetrafluoroethylene. Another preferred embodiment has a stent graft which includes at least one stent sandwiched between the ends of two tubular shaped grafts wherein at least a portion of the grafts are unsupported by the stent. Still another embodiment includes an articulating stented graft which includes a plurality of stents spaced apart from one another at a predetermined distance wherein each stent is contained between two elongated biocompatible tubular members. The graft/stent/graft assemblies all have inseparable layers.

Abstract: A heart valve prosthesis and method of implanting the prosthesis are disclosed. A valve is mounted within a support apparatus that is deformable between a first condition and a second condition. The prosthesis has a cross-sectional dimension in the second condition that is less than a cross-sectional dimension of the supported valve when in first condition. The prosthesis can be implanted into a patient's heart, such as during a direct vision procedure through a tubular implantation apparatus that maintains the prosthesis in its second condition until discharged from the tubular apparatus.

Abstract: Anastomotic stents for connecting a graft vessel to a target vessel, and methods of use thereof. The anastomotic stents of the invention are suitable for use in a variety of anastomosis procedures, including coronary artery bypass grafting. One embodiment of the invention comprises a large vessel anastomotic stent for use with large diameter target vessels such as the aorta or its major side branches. Another embodiment of the invention comprises a small vessel anastomotic stent for use on a target vessel which has a small diameter such as a coronary artery. Another aspect of the invention involves applicators for use with the stents of the invention.

Abstract: Methods and apparatus for making an anastomotic connection between tubular fluid conduits in a patient. A connector may provided having an annular structure configured for placement partially within one of the tubular fluid conduits and for annular enlargement by expansion of an expandable structure positioned within an interior portion of the connector. The connector may be configured for plastic annular enlargement, and have members with free end portions that are configured to penetrate a wall of the tubular fluid conduits at locations that are annularly spaced around the connection. A portion of the connector may be selectively deflected radially out from a remainder of the connector in response to expansion of the expandable structure disposed inside the connector.

Abstract: A bifurcated or straight intravascular folded tubular member is deliverable percutaneously or by small cutdown to the site of a vascular lesion. Its inserted state has a smaller nondeployed diameter and a shorter nondeployed length. The intravascular tubular member has a folded tubular section that is unfolded following insertion into the blood vessel. The length of the intravascular folded tubular member is sized in situ to the length of the vessel lesion without error associated with diagnostic estimation of lesion length. The folded tubular member is self-expandable or balloon-expandable to a larger deployed diameter following delivery to the lesion site. An attachment anchor can be positioned at the inlet or outlet ends of the intravascular folded tubular member to prevent leakage between the tubular member and the native vessel lumen and to prevent migration of the tubular member. The attachment anchor has a short axial length to provide a more focal line of attachment to the vessel wall.

Abstract: Anastomotic stents for connecting a graft vessel to a target vessel, and methods of use thereof. The anastomotic stents of the invention are suitable for use in a variety of anastomosis procedures, including coronary artery bypass grafting. One embodiment of the invention comprises a large vessel anastomotic stent for use with large diameter target vessels such as the aorta or its major side branches. Another embodiment of the invention comprises a small vessel anastomotic stent for use on a target vessel which has a small diameter such as a coronary artery. Another aspect of the invention involves applicators for use with the stents of the invention.