Abstract: The stent for angioplasty has a body in the form of a generally tubular casing capable of being dilated in use from a radially-contracted position to a radially-expanded position. The body includes a support structure made from a first material capable of withstanding this dilation without losing its structural integrity. A structure made from a second material which has been rendered radioactive following the exposure of the stent itself to a neutron flux is associated with at least a portion of the carrying structure.

Abstract: A stent or intraductal medical device manufactured from a tubular member having an inner tube tightly fitted into an outer tube is provided. Microdepots may be formed on the outer surface of the inner tube, and may contain radioactive, radiopaque or therapeutic substances. A method for manufacturing such a medical device or stent is also described. The material to be deposited on the inner tube may be deposited on the inner tube by dipping or immersion, or the material may be applied to the inner tube using micro-injection or electrodeposition. The material to be deposited may be applied to cavities or microdepots formed in the outer surface of the inner tube. Excess material may be removed from the inner tube by centrifugation or shaking, and the material to be deposited may be heated to bond the material to the surface of the microdepots on the inner tube.

Abstract: An endoprosthesis, such as a stent, having a layer that can enhance the biocompatibility of the endoprosthesis, and methods of making the endoprosthesis are disclosed.

Abstract: The stent (1) has surface sculpturing, preferably on its outer surface (2) only, constituted, for example, by microspheres (3), having the function of increasing the actual geometric surface area of the stent, of creating undercuts and roughness to encourage the application of coatings of active or activatable agents, as well as of improving the attachment of the stent (1) to the blood vessel wall.

Abstract: One aspect of the present invention provides implantable medical devices that comprise: (a) a device body; and (b) a surface layer attached to at least a portion of the device body, the surface layer comprising: (1) a surface layer body that defines an internal surface attached to the device body, and an external surface; and (2) a multiplicity of blood vessels disposed within the surface layer body, the blood vessels opening onto the external face of the surface layer body. The present invention also provides synthetic biocompatible materials, methods for making synthetic biocompatible materials, and methods for making implantable medical devices.

Abstract: A stent radially expandable from a radially contracted introduction state into a radially expanded position state, in which the final shape of the stent can be controlled by varying the amount and places energy is delivered onto the interior surfaces of the tubes from which the stent is fabricated, and means to seal the opening into the aneurysm, thereby causing the blood therein to clot and preventing the aneurysm from growing or rupturing.

Abstract: A method of making an tubular intraluminal graft in the form of a tubular diametrically adjustable stent having a tubular covering of porous expanded polytetrafluoroethylene which is less than 0.10 mm thick. The covering may be on the exterior surface of the stent, or on the interior surface of the stent, or both. The covering may be affixed to the stent by an adhesive which is preferably fluorinated ethylene propylene.

Abstract: A flexible covered stent includes a stent covered on a first surface by a first layer of biocompatible material and on a second surface by a second layer of biocompatible material, the first and second layers of biocompatible material being bonded to one another through a wall in the stent. The first layer of biocompatible material is longer than the second layer of biocompatible material such that at least a portion of the second surface of the stent is left uncovered, imparting flexibility to the stent. A mid portion of the second surface of the stent can be left uncovered to impart flexibility to the stent similar to that enjoyed by a bare stent.

Abstract: The invention is of the design for, and a method of use of, an improved surgical stent. The stent is coated with a slow-release calcium channel blocker agent which interrupts the accumulation or deposition of fibrotic tissue as occurs in the process of re-occlusion of the vessel, orifice, or conduit as attends the use of conventional stents.

Abstract: A device, which comprises a surface layer that has incorporated therein at least one radioactive nuclide. The surface layer is a self-assembled layer, particularly an anchored SAM that is selected from the group consisting of monolayers or films anchored by siloxane, thiol, amine or phosphonate. The surface layer may be formed of a radioactive material that has been activated to induce radioactivity therein after its final formation. The device may comprise a chemically functionalized SAM incorporating radionuclides attached at the surface of the device. The device may be a temporary or permanent therapeutic implant, such as a stent.

Abstract: In a process for producing a biocompatible stent, a tubular substrate of the stent adapted for diametric expansion has a layer of a noble metal oxide formed over at least the outer surface of greater diameter of the substrate, the substrate being composed of a metal or an alloy thereof that is non-noble or less-noble than the layer's noble metal. An interface region adapted to prevent corrosion and to provide a firm bond between the surface of the substrate and the noble metal oxide layer is established, at least in part, by forming the noble metal oxide layer with a progressively varying concentration of noble metal-to-oxide with depth of the layer such that a surface of pure noble metal and negligible oxide of the layer is in closest proximity to the surface of the substrate. In one embodiment of the process, the interface region is established by forming the surface of pure noble metal and negligible oxide thereof in direct contact with the metal or alloy of the substrate surface.

Abstract: A composite intraluminal prosthesis which is preferably used as a vascular prothesis includes a layer of ePTFE and a layer of textile material which are secured together by an elastomeric bonding agent. The ePTFE layer includes a porous microstructure defined by nodes interconnected by fibrils. The adhesive bonding agent is preferably applied in solution so that the bonding agent enters the pores of the microstructure of the ePTFE. This helps secure the textile layer to the ePTFE layer.

Abstract: A vascular implant includes a scaffold and a tubing in covering relating to the scaffold. Preferably, the tubing completely covers or encases the scaffold interior surface and exterior surface to leave no portion of the scaffold exposed. Methods for constructing includes pulling tubing through a scaffold and folding at least a portion of the tubing over at least one of the ends of the scaffold. Methods for using an implant include performing coronary vessel bypass procedures or forming blood flow paths in a blood vessel utilizing constructions described herein.

Abstract: A portion of a covered stent is encapsulated with ePTFE, so that the unencapsulated portion, which is covered by a single ePTFE covering, imparts an unimpaired flexibility to the stent. One surface of the stent, either the luminal or abluminal surface, is covered by a single continuous layer of ePTFE, while limited regions, preferably near the ends of the stent, of the other surface are also covered by ePTFE. The regions covered by ePTFE on both surfaces become encapsulated when the ePTFE of one layer becomes bonded to second layer. By leaving a middle region of the stent unencapsulated, the stent retains flexibility similar to a bare stent, thereby reducing the loading and deployment forces.

Abstract: An apparatus (10) for grafting of a blood vessel (12) and a method of forming the apparatus (10) is provided. The apparatus (10) comprises an expandable support member (16) having inner and outer surfaces (36 and 34). The outer surface (34) of the expandable support member (16) is for engaging and adhering to an inside surface (68) of the blood vessel (12). A layer of biological tissue (14) is attached to the inner surface (36) of the support member (16). The layer of biological tissue (14) has an uninterrupted inwardly facing surface (50) for extending confluently with the inside surface (68) of the blood vessel (12) to provide resistance to thrombosis and platelet deposition.

Abstract: An intravascular metal stent having a tubular wall and a biocompatible coating on at least a major part of the wall surface which coating has a thickness of less than 4 &mgr;m and contains a diamond like amorphous material, preferably DLN.

Abstract: The invention is directed to bioengineered vascular graft support prostheses prepared from cleaned tissue material derived from animal sources. The bioengineered graft prostheses of the invention are prepared using methods that preserve cell compatibility, strength, and bioremodelability of the processed tissue matrix. The bioengineered graft prostheses are used for implantation, repair, or for use in a mammalian host.

Abstract: A vascular graft comprising a traditional graft material and an electrospun fibrous layer. The solvent used to reduce the material for the electrospun layer is also capable of reducing the graft material to a liquid solution. The electrospun layer is chemically bonded to the graft material, without adhesives, by either spraying the graft with the solvent prior to electrospinning or by assuring that a sufficient amount of residual solvent reaches the graft while electrospinning.

Abstract: A stent-graft endoprosthesis is provided. The graft is a non-textile graft made from biocompatible polymers. The biocompatible compatible polymers include poly-para-xylylene polymeric material. The stent is also coated with a poly-para-xylylene polymeric material. The graft is formed by vacuum vapor deposition of diradicals forming the poly-para-xylylene material. The stent is also coated with the poly-para-xylylene material by vacuum vapor deposition.

Abstract: Percutaneous treatment of aortic aneurysms and like vascular anomalies by an apparatus and method wherein the apparatus is delivered via catheter and comprises a sleeve with at least one peripheral conduit which is caused to assume an expanded, rigid configuration by the introduction of a chemical or mechanical hardening means, whereby the sleeve is caused to assume an open cylindrical configuration for fluid flow therethrough.

Abstract: A tubular intraluminal graft in the form of a tubular diametrically adjustable stent having a tubular covering of porous expanded polytetrafluoroethylene which is less than 0.10 mm thick. The covering may be on the exterior surface of the stent, or on the interior surface of the stent, or both. The covering may be affixed to the stent by an adhesive which is preferably fluorinated ethylene propylene.

Abstract: A vascular prosthesis is constructed from a structure having interconnected, helically oriented channel-porosity to allow oriented ingrowth of connective tissue into a wall of the prosthesis. The prosthesis can have a small internal diameter of 6 mm or less. Several different methods can be used to produce the prosthesis, including a fiber winding and extraction technique, a melt extrusion technique, and a particle and fiber extraction technique using either a layered method or a continuous method. Furthermore, mechanical properties of the prosthesis are matched with mechanical properties of the host vessel, thereby overcoming problems of compliance mismatch.

Abstract: A method of providing a therapeutic, diagnostic or lubricious hydrophilic coating on an intracorporeal medical device and the coated device produced thereby, wherein the coating is durable. In one embodiment, the coating comprises a polymerized base coat and a top coat having a therapeutic, diagnostic or hydrophilic agent, where the base coat has a binding component which binds to the top coat, and a grafting component which binds to the binding component and adheres to the device. In another embodiment, the coating comprises a blend of an agent, a grafting component, and salt. In one embodiment, the therapeutic agent is superoxide dismutase or a superoxide dismutase mimic. The coating of the invention may be applied to a medical device with a polymeric surface such as a polymeric catheter, or a metal device such as a stent coated with a polymeric primer or without a primer.

Abstract: A vascular prosthesis is constructed of an inner porous tube which allows uninterrupted cellular growth and which is connected to an adventitial sock surrounding the porous tube. The adventitial sock produces a non-linear elastic response to stress-strain on the prosthesis to optimize compliance and prevent over dilatation.

Abstract: A silver implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one layer 18 of a bioactive material posited on one surface of structure 12; and at least one porous layer 20 posited over the bioactive material layer 18 posited on one surface of structure 12 and the bioactive-material-free surface. Also included is a layer or impregnation of silver 45. Preferably, the structure 12 is a coronary stent. The porous layer 20 is comprised of a polymer applied preferably by vapor or plasma deposition and provides a controlled release of the bioactive material. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative, which is deposited without solvents, heat or catalysts, merely by condensation of a monomer vapor. Silver is included as a base material, coating or included in a carrier, drug, medicament material utilized with the implantable stent.

Abstract: A multilayer device comprised of at least one layer of material which is capable of absorbing liquid to thereby increase the volume of the layer, i.e., liquid swellable, and when bound to at least one non-absorbing or lesser absorbing layer of material causes deformation of the device upon liquid absorption.

Abstract: An implantable appliance (1) comprises a front end wire ring (2), one or more intermediate wire rings (5) and a rear end wire ring (3) connected by a tubular cover (4). The wire rings (2), (3) and (5) are flexibly foldable. A front end portion (1a) of the appliance (1) is equally divided into four or an even number over four segments with dividing points (6a), (6b), (6c), (6d) between the segments, and a front hooking portion (8) for hauling the appliance (1) is formed at midpoints between the dividing points (6a), (6b), (6c), (6d) and the dividing points (6b), (6c), (6d), (6a). The invention includes a method in which the front end portion (1a) is collapsed into a wavy shape with every other dividing point (6a), (6c) forming forwardly directed peaks and other dividing points (6b), (6d) forming the bottoms of forwardly directed valleys, such that front hooking portions are located between adjacent peaks and valleys.

Abstract: A stent having an expandable inner layer and a channel thereon to direct blood flow and induce a rotational motion therein, thereby increasing the speed of blood flowing through the stent and reducing the likelihood of blood clotting, thrombosis, and restenosis.

Abstract: An apparatus (10) for grafting of a blood vessel (12) and a method of forming the apparatus (10) is provided. The apparatus (10) comprises an expandable support member (16) having inner and outer surfaces (36 and 34). The outer surface (34) of the expandable support member (16) is for engaging and adhering to an inside surface (68) of the blood vessel (12). A layer of biological tissue (14) is attached to the inner surface (36) of the support member (16). The layer of biological tissue (14) has an uninterrupted inwardly facing surface (50) for extending confluently with the inside surface (68) of the blood vessel (12) to provide resistance to thrombosis and platelet deposition.

Abstract: An implantable microporous ePTFE tubular vascular graft exhibits long term patency, superior radial tensile strength and suture hole elongation resistance. The graft includes a first ePTFE tube and a second ePTFE tube circumferentially disposed over the first tube. The first ePTFE tube exhibits a porosity sufficient to promote cell endothelization, tissue ingrowth and healing. The second ePTFE tube exhibits enhanced radial strength in excess of the radial tensile strength of the first tube.

Abstract: A stent structure includes a stent and one or more fibers disposed on the stent, the fiber adapted to provide a therapeutic agent. Nuclei containing therapeutic agents that impede restenosis may be included within the fiber or within separate particles that are contained within hollow core fibers. The fibers and the particles may be bioerodible. A permeable, biocompatible sheath may be interposed between the stent and the fiber. A kit including a stent, a fiber, and a delivery catheter is also described.

Abstract: A stent for use in a patient's blood vessel to maintain the patency of the vessel contains strategically located radiopaque material. The strategic placement of the radiopaque material in the core structure of the stent functions to enhance the resolution of the stent under fluoroscopy. The initial part of the process includes forming a groove in a piece of tube stock and securing radiopaque material into the groove by press fitting or diffusion bonding. After the securing method, a layer of material can be sputtered coated over the only radiopaque material or over the entire stent. Finally, a pattern of struts and splines is cut into the tube composite to form the stent.

Abstract: The present invention relates to a process for preparing surface modifications having an improved antithrombogenic activity, whereby the improvement is achieved by treating heparin at a temperature above 40° C. or a pH in the rage of 9-14 or in contact with nucleophilic catalysts before attaching said heparin to the surface to be modified.

Abstract: A new multiple component stent arrangement which allows for initial self-expansion and subsequent deformation to a final enlarged size. These tissue supporting devices are generally cylindrical or tubular. They have at least one component which is deformable, by an external force, to maintain further expansion.

Abstract: Shape memory alloy and elastically self-expanding endoluminal stents which are at least partially encapsulated in a substantially monolithic expanded polytetrafluoroethylene (“ePTFE”) covering. An endoluminal stent, which has a reduced diametric dimension for endoluminal delivery and a larger in vivo final diametric diameter, is encapsulated in an ePTFE covering which circumferentially covers both the luminal and abluminal walls along at least a portion of the longitudinal extent of the endoluminal stent. The shape memory endoluminal stent is fabricated from a shape memory alloy which exhibits either shape memory or pseudoelastic properties or from an elastic material having an inherent spring tension.

Abstract: The stent comprises a cylindrical wall formed by meshed wires and a covering layer of elastic material extending on a portion of its length, with an outer surface, and totally embracing the wire mesh.

Abstract: The present invention provides a method for preparing an implantable, medical device having at least one radioactive metallic surface. The method comprises the steps of depositing a radioactive metal layer onto the surface of the device. The metal layer comprises a radioactive metal that emits beta particles and that has a half-life of between 2 hours and 7 days and a maximum beta energy of between 0.7 and 2.3 MeV. In one embodiment, the radioactive layer is deposited by electroplating the radioactive metal and a carrier metal onto the metallic surface. In another embodiment, the method further comprises the step of electroplating a second metallic layer comprising a barrier metal onto the radioactive metal layer. The present invention also provides an implantable medical device comprising a surface having a metallic surface comprising a radioactive metallic coating thereon. The coating comprises a radioactive layer comprising a radioactive metal that emits beta-particles.

Abstract: A process and apparatus for dip-coating intermediate and/or discrete discontinuous portions of longitudinal devices, including medical devices such as catheters and guidewires. The apparatus provides a chamber in which both the desired portion(s) of the device and the coating solution can be controllably contacted. A controlled coating can be achieved within the chamber by providing and controlling one or more of the following relationships: a) the manner in which a chamber (containing solution) is itself moved with respect to a static device, b) the manner in which the device is moved with respect to a fixed chamber position containing a fixed volume of solution, and/or c) the manner in which both the chamber and device are fixed in position, and the coating is achieved by adding and removing a volume of solution from the chamber.

Abstract: Partially encapsulated stents are made using gaps cut into ePTFE covering material. Ring stents are placed over an inner ePTFE tube (e.g., supported on a mandrel) and are covered by a “lacey” graft sleeve, which is constructed by cutting apertures into an ePTFE tube so that a series of circumferential and longitudinal strips is created. This “lacey” sleeve is then laminated to the inner ePTFE tube to capture the stents. By selecting the size and position of the apertures in the ePTFE covering, it is possible to leave critical parts of the stent unencapsulated to facilitate flexibility and expansion. Alternatively, the gaps can consist of slits cut into the ePTFE covering material. These slits can be cut in any direction including longitudinally, radially, or diagonally. In addition, the slits can be spaced at varying intervals around the covering material to maximize flexibility and expandability.

Abstract: A prosthesis for replacing or strengthening a particular part of the body is coated with a biodegradable, resorbable and biocompatible surface coating. Biologically active microspheres which controllably release the biologically active agents are embedded in the surface coating. The biologically active microspheres include encapsulated PGE1 in a polyethylene glycol mix, which over a period of time dissolves and releases the PGE1 into the body part.

Abstract: A stent configuration wherein a radiopaque material is completely encapsulated in a skin of biocompatible material to prevent the exposure of radiopaque materials to living tissue and to prevent galvanic corrosion between disparate metals. The stent is initially formed and rendered radiopaque after which all surfaces are coated with the biocompatible material.

Abstract: A stent-graft composite intraluminal prosthetic device comprises an elongated radially adjustable tubular stent and a polyolefin stent cover positioned about an exterior surface and/or interior surface thereof. The composite device is formed heat melting a film-like layer of polyolefin material onto a stent placed on a mandrel. The film has opposed longitudinal edges which are joined to form a tubular structure. The stent has a plurality of open spaces extending between opposed interior and exterior surfaces to permit radial adjustability, and the stent and cover are secured together through the open spaces of the stent. When both an exterior stent surface and interior stent surface are to be covered, such layers may be adheringly secured through the spaces by an adhesive, or laminated together through the open spaces of the stent.

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: The stent comprises a cylindrical wall formed by meshed wires and a covering layer of elastic material extending on a portion of its length, with an outer surface, and totally embracing the wire mesh.

Abstract: Shape memory alloy and elastically self-expanding endoluminal stents which are at least partially encapsulated in a substantially monolithic expanded polytetrafluorethylene (“ePTFE”) covering. An endoluminal stent, which has a reduced diametric dimension for endoluminal delivery and a larger in vivo final diametric diameter is encapsulated in an ePTFE covering which circumferentially covers both the luminal and abluminal walls along at least a portion of the longitudinal extent of the endoluminal stent. The shape memory endoluminal stent is fabricated from a shape memory alloy which exhibits either shape memory or pseudoelastic properties or from an elastic material having an inherent spring tension.

Abstract: A tubular prosthesis device for use within the body. The device includes, a metal filament material formed of metal outer member having an exposed outer surface and a core within the extended outer member formed of a different metal than the outer member. The core is secured within and substantially enclosed by the outer member. The device can be reduced to a small size for introduction into the body lumen and expandable to a sufficiently large size to engage the wall of the body lumen. Stents formed of composite wires are shown.

Abstract: An easy-to-produce and mechanically strong tube of an implantable graft prosthesis has been developed which is manufactured in any desired length, wall thickness, or diameter. The construct produced by the method of the invention may be used as grafts for arteries, veins, ureters, urethras, shunts, or in any application where a compliant, tissue-compatible tube is needed. The manufacture of the graft prosthesis generally involves wrapping multiple sheets of a purified, collagen-based matrix structure around a mandrel, compressing and drying the tissue on the mandrel before removing the construct for eventual use.

Abstract: An endovascular support device adapted for local delivery of a therapeutic agent and for minimizing the rate of restinosis having a cylindrical support body with an inside surface and an opposite outside surface, and at least one layer of pericardial tissue covering at least a portion of at least a selected one of the inside surface or the outside surface of the cylindrical support body. At least one therapeutic agent is disposed on a portion of the support device.

Abstract: A endovascular graft having at least two thin wall graft members, with at least one of the thin wall graft members configured to be deployed within a lumen of another thin wall graft member. The thin wall graft members may be coupled or connected to each other so as to allow relative axial displacement of the sections, or they may be separate members that have dimensions and a configuration to allow coaxial deployment within inner lumens of each other. By having multiple thin wall graft member, the graft may be built up within a patient's vasculature in steps through a delivery catheter system that is smaller in profile and more flexible than a delivery catheter system configured to deliver a single component graft. The graft of the invention may be delivered percutaneously or intraoperatively.

Abstract: A endovascular graft having at least two thin wall graft members, with at least one of the thin wall graft members configured to be deployed within a lumen of another thin wall graft member. The thin wall graft members may be coupled or connected to each other so as to allow relative axial displacement of the sections, or they may be separate members that have dimensions and a configuration to allow coaxial deployment within inner lumens of each other. By having multiple thin wall graft member, the graft may be built up within a patient's vasculature in steps through a delivery catheter system that is smaller in profile and more flexible than a delivery catheter system configured to deliver a single component graft. The graft of the invention may be delivered percutaneously or intraoperatively.