Abstract: An improved inflow conduit for an implantable ventricular assist device comprising covering the flexible porous tubular graft body of the conduit with an attached non-porous polymer to produce a non-porous conduit. The flexible conduit has an upstream end and a downstream end, a ventricular attachment structure to which the upstream end of the body connects; and a coupling fitting on the downstream end of the body. Also taught is a combination of the improved inflow conduit with an implantable ventricular assist device. A method for the treatment of congestive heart failure, comprising implanting the implantable ventricular assist device in a patient in need of such treatment, as well as an article of manufacture, comprising packaging material and the implantable ventricular assist device contained within the packaging material are also provided.

Abstract: The invention is directed to methods of making bioremodelable graft 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 use in a mammalian host.

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: Methods for fabricating coatings for implantable medical devices are disclosed. The coatings include blends of hydrophilic and hydrophobic polymers. The methods provide for treatment of the coatings to cause enrichment a region close to the outer surface of the coating with the hydrophilic polymers.

Abstract: Coatings for implantable devices or endoluminal prosthesis, such as stents, are provided, including a method of forming the coatings. The coatings can be used for the delivery of an active ingredient or a combination of active ingredients.

Abstract: A coating for implantable medical devices including an interpenetrating polymer network serving as a rate limiting barrier.

Abstract: An endoluminal device, such as a stent or a vena cava filter, comprising at least one superelastic section and at least one plastically deformable section. The superelastic section may comprise, for example, a superelastic grade of nitinol, whereas the plastically deformable section may comprise, for example, gold, platinum, tantalum, titanium, stainless steel, tungsten, a nickel alloy, a cobalt ally, a titanium alloy, or a combination thereof. Each plastically deformable section may merely comprise a constrained portion of the superelastic section comprising a plastically deformable material, such as gold.

Abstract: A tape-reinforced tubular vascular graft formed of sintered fluoropolymer(s), such as expanded, sintered PTFE. The graft includes a base graft and a reinforcing tape applied thereto. The tape may be spirally wrapped about the graft or spirally wrapped into a tube about a cylindrical mandrel and then applied to the exterior of The graft. Radial shrinkage of the combined base graft and tape, or of the reinforcing tape tube, renders the vascular graft subsequently radially enlargeable by more than 5%, without tearing or breaking of the reinforcement tape layer of the graft. Radially enlargeable grafts of the present invention may be combined with various types of stents or anchoring systems, to form endovascular graft devices which are transluminally insertable and implantable within the lumen of a host blood vessel.

Abstract: Metal foils, wires, and seamless tubes with increased mechanical strength are provided. As opposed to wrought materials that are made of a single metal or alloy, these materials are made of two or more layers forming a laminate structure. Laminate structures are known to increase mechanical strength of sheet materials such as wood and paper products and are used in the area of thin films to increase film hardness, as well as toughness. Laminate metal foils have not been used or developed because the standard metal forming technologies, such as rolling and extrusion, for example, do not lend themselves to the production of laminate structures. Vacuum deposition technologies can be developed to yield laminate metal structures with improved mechanical properties. In addition, laminate structures can be designed to provide special qualities by including layers that have special properties such as superelasticity, shape memory, radio-opacity, corrosion resistance etc.

Abstract: An arterial prosthesis comprising biological inert polyester and polyurethane yarns, at last of portion of said yarns being agglutinated with gelatin/glycerin solution bonds.

Abstract: A stent to be implanted in a lumen in a living body comprises a stent main body, and a polymer layer provided on a surface of the stent main body, wherein the polymer layer comprises a first biologically/physiologically active substance, and nano- or micro-capsules composed of a first biodegradable polymer and comprising a second biologically/physically active substance therein, and the second biologically/physically active substance is released after the first biologically/physiologically active substance is released to the exterior of the stent.

Abstract: A bypass graft includes a tubular portion having an internal tubular diameter and a first end and a second end. The tubular portion has a central axis. A flared portion has an adjoining end, wherein the adjoining end of the flared portion is integrally formed on and is substantially concentric with the second end of the tubular portion, and a flared end, wherein the flared end has a flared end internal diameter, such that the internal flared end diameter is greater than the internal tubular diameter. The flared portion includes a circumferential skirt for surgical attachment of the graft to a patient's blood vessel.

Abstract: A medical device comprising a combination of one or more dynamic structural elements and one or more non-dynamic structural elements and having a first structural form immediately after deployment in a body, the device adapted to change in vivo to a second structural form due to a change induced in the one or more dynamic structural elements without releasing debris greater than a predetermined size. An exemplary device may comprise at least one biodegradable element contained radially between a first confining member and a second confining member.

Abstract: An encased stent that discourages restenosis by having a homogenous endothelial cell lining along the inner wall of the stent. The endothelial cell lining may be coated on the stent before the stent is placed in the artery, or the endothelial cell lining may be grown after placement by several factors that encourage such growth and discourage restenosis. The endothelial cells to coat the stent may be genetically modified to enhance the growth of the endothelial cells into a homogeneous lining. The stent has a continuous lining in the form of a multi-layer polymer coating, including a conducting biocorrosion inhibiting layer and a continuous film of polyurethane coupled by a coupling agent to polyethylene glycol. Various drugs and cell factors may be incorporated into the lining, such as anti-thrombin, anti-inflammatory and anti-coagulant drugs, cell cycle inhibitors, and vascular endothelial growth factors.

Abstract: The present invention provides a soft-tissue prosthesis which is formed from a tubular textile substrate and a liner. The liner is affixed to the intraluminal surface of the tubular textile portion of the soft-tissue prosthesis to form a fluid-tight barrier on the intraluminal surface of the prosthesis. The liner is preferably formed from a polymer. Thus, the soft-tissue prosthesis formed in accordance with the present invention provides the advantages of both a textile prosthesis and a polymer prosthesis.

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: The invention provides a self-sealing arteriovenous graft including a tube having a polymeric inner layer defining a lumen through which blood may flow and an outer textile layer. The outer textile layer is concentrically disposed about the inner layer. Furthermore, an intermediate self-sealing layer is concentrically positioned between the inner and outer layers. The self-sealing layer includes a biocompatible polymer.

Abstract: A flexible covered stent having a stent covered on a first surface by a first layer of biocompatible material and on a second surface by both a second and third layer of biocompatible material, the first and second layers and the first and third layers of biocompatible material being bonded to one another through openings in a wall in the stent. The first layer of biocompatible material is longer than both the second and third layers of biocompatible material such that at least a portion of the second surface of the stent is not covered by either second or third layer, imparting flexibility to the stent.

Abstract: An expandable stent designed to maintain a passageway through a body lumen of a patient is disclosed. The expandable stent is a tubular member that includes a thermoplastic material and woven or wound fibers at least partially in contact with the thermoplastic material, such that the thermoplastic material maintains the tubular member in at least one of an expanded state and a collapsed state.

Abstract: The present invention relates to a stent comprising a structural support and a polymeric film or sheet or tube. The structural support comprises an outer surface that is roughened patterned. The polymeric film or sheet or tube is retained to the structural support by the roughened or patterned outer surface of the structural support.

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 method of forming a composite textile and ePTFE implantable device includes the steps of (a) providing an ePTFE layer having opposed surfaces comprising a microporous structure of nodes interconnected by fibrils; (b) providing a textile layer having opposed surfaces; (c) applying a coating of an elastomeric bonding agent to one of the opposed surfaces of the ePTFE layer or the textile layer; (d) providing a hollow member having an open end and an opposed closed end defining a fluid passageway therebetween and having a wall portion with at least one hole extending therethrough, the hole being in fluid communication with the fluid passageway; (e) concentrically placing the ePTFE layer and the textile layer onto the hollow member and over the at least one hole of the hollow member to provide an interior composite layer and an exterior composite layer, thereby defining a composite assembly, wherein the interior composite layer is one of the ePTFE layer or the textile layer and the exterior composite layer is th

Abstract: Coatings for implantable devices or endoluminal prosthesis, such as stents, are provided, including a method of forming the coatings. The coatings can be used for the delivery of an active ingredient or a combination of active ingredients.

Abstract: Stented tubular grafts of expanded, sintered polytetrafluoroethylene (PTFE). The stented PTFE grafts of the present invention include an integrally stented embodiment, an externally stented embodiment, and an internally stented embodiment. In each embodiment, the stent may be either self-expanding or pressure-expandable. Also, in each embodiment, the stent may be coated or covered with a plastic material capable of being affixed (e.g., heat fused) to PTFE. Manufacturing methods are also disclosed by the individual components of the stented grafts are preassembled on a mandrel and are subsequently heated to facilitate attachment of the PTFE layer(s) to one another and/or to the stent Optionally, the stented graft may be post-flexed and post-expanded following it's removal from the mandrel to ensure that the stented graft will be freely radially expandable and/or radially contractible over it's full intended range of diameters.

Abstract: An aneurysm treatment device for in situ treatment of aneurysms comprising a collapsible member having a first shape wherein the first shape is an expanded geometric configuration, and a second shape, wherein the second shape is a collapsed configuration that is loadable into a catheter. The aneurysm treatment device is capable of returning to the first shape in the lumen of an aneurysm. Some aneurysm treatment devices comprise a spreadable portion and a projecting portion integral with the spreadable portion. The spreadable portion is capable of resting against and supporting an inner wall of an aneurysm, the projecting portion is capable of being gripped by a surgeon to facilitate insertion and positioning of the device. Other devices have relatively simple shapes and can be implanted to a site as a plurality. Treatment methods are also disclosed.

Abstract: A prosthesis, and method for forming same, are provided which includes expanded polytetrafluoroethylene (ePTFE) tubes having angularly offset node and fibril configurations. Also, the node and fibril configurations are angularly offset from the longitudinal axes of the respective tubes, providing resistance against failure in the longitudinal direction.

Abstract: A stent is adapted to be implanted in a duct of a human body to maintain an open lumen at the implant site, and to allow viewing body tissue and fluids by magnetic resonance imaging (MRI) energy applied external to the body. The stent constitutes a metal scaffold. An electrical circuit resonant at the resonance frequency of the MRI energy is fabricated integral with the scaffold structure of the stent to promote viewing body properties within the lumen of the stent.

Abstract: Medical devices, such as stents, stent-grafts, grafts, guidewires, and filters, having enhanced radiopacity are disclosed.

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 implantable stent prosthesis comprises a sidewall and at least one channel for containing a biologically active material. A method for making such stent prosthesis is also disclosed. In the method, at least one tube or mandrel is placed in contact with a covering material on a stent and surrounded by the covering material to form a channel. Alternatively, a channel can be formed by covering tube or mandrel with a channel material and exposing the covered tube or mandrel to an appropriate treatment. The channel can be attached to a sidewall of a stent or attached to a strut material to form a stent wire. A method of treating an afflicted area of a body lumen by implanting the stent prosthesis is also disclosed.

Abstract: A membrane that reduces the rate at which a therapeutic substance is released from an implantable medical device, such as a stent, is disclosed.

Abstract: The present invention includes biocompatible coatings and films for use on implantable medical devices and medical devices containing such coatings and films applied to a surface thereof, which coatings/films are present on the device in an amount effective to provide an inert surface to be in contact with body tissue of a mammal upon implantation of the device in the mammal, and contain a film-forming polyfluoro copolymer containing the polymerized residue of a moiety selected from the group consisting of vinylidenefluoride and tetrafluoroethylene copolymerized with a second moiety other than the first moiety, wherein the relative amounts of the polymerized residue of the first and second moieties are effective to provide the coating and films with properties effective for use in coating implantable med devices.

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: Medical devices including an organic-inorganic composite material, including methods of making the devices, are disclosed.

Abstract: A coated medical device (10) including a structure (12) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material (14) having a bioactive material layer (18) disposed thereon. The medical device is preferably an implantable stent or balloon (26) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material (58) positioned between the base and bioactive material layers of the balloon.

Abstract: A prosthesis, and method for forming same, are provided which includes expanded polytetrafluoroethylene (ePTFE) tubes having angularly offset node and fibril configurations. Also, the node and fibril configurations are angularly offset from the longitudinal axes of the respective tubes, providing resistance against failure in the longitudinal direction.

Abstract: Ablation of the pulmonary veins causes damage to the tissue which may affect the viability of the tissue. By placing a stent, a vascular endoprosthesis, within a target pulmonary vein it is possible to protect the functionality of the veins after the ablation procedure. Placement of a stent, endoprosthesis or mere circuit interrupting structure into a target pulmonary vein, without ablation, prevents aberrant electrical activity in the pulmonary veins from interfering with the electrical activity of the left atrium. The stent, endoprosthesis or circuit interrupting structure may also be coated or comprised of a drug-eluting compound, loaded with a drug which inhibits arrhythmia.

Abstract: A vascular prosthesis comprising a first layer having a predetermined first porosity and a second layer having a predetermined second porosity, wherein the first layer and the second layer are each made of first and second electrospun polymer fibers.

Abstract: Medical devices, medical device components, and methods of making the same. For example, one embodiment provides a method of shaping a reinforcing member through annealing. Another exemplary embodiment includes a method of making a medical device that includes such a shaped reinforcement member incorporated therein. Yet another exemplary embodiment provides a medical device including such a shaped reinforcing member therein.

Abstract: A stent having a multi-layered coating adhered to its surface which can prevent restenosis and thrombosis at the implant site. The stent coating is comprised of two layers. The first layer is a polymeric coating with one or more biologically active agent(s) dispersed therein. The second layer is comprised of a hydrophobic heparinized polymer that inhibits blood coagulation and provides a hydrophilic surface for reducing the friction between stent and lesion site. In preferred embodiments of the invention, the multi-layered stent is effective in deterring restenosis and thrombosis at the implant site. In these same preferred embodiments, the multi-layered stent is capable of reducing the burst release of the biologically active agents from the first layer and sustaining a release of an effective amount of these agents for a relatively extended period of time. Methods of applying the multi-layered coating to the stent surface are also part of this invention.

Abstract: The present invention relates to a support structure/membrane composite device which includes a support structure, such as a radially expandable stent, a porous non-textile polymeric membrane adjacent to said stent and a thermoplastic anchor means attaching said stent to said porous non-textile polymeric membrane. The porous non-textile polymeric membrane is preferably made from expandable fluoropolymer materials. The anchoring means is a thermoplastic material which is dissolvable at the interface between the support structure and membrane by a suitable solvent which wets the membrane surface and deposits the thermoplastic material within the pores of the membrane. Methods of preparing the device are also disclosed.

Abstract: A prosthesis for a blood vessel, which is an expanded porous polytetrafluoroethylene tube having a fine fibrous structure with nodes connected to each other by fibrils. The average fibril length is at least 40 &mgr;m, and the tube has a porosity of at least 70%. The load required for compressing the tube by 10% in its axial direction at a strain rate of 100%/min is at least 10 gf. The resistant force per unit sectional area of the tube produced upon the 10% compression is at least 1.0 gf/mm2.

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: The present invention is an improved endovascular device particularly useful for use in transjugular intrahepatic portosystemic shunt (TIPS) procedures. The device employs a two-part stent-graft construction that provides a low permeability membrane to line the shunt and an uncovered stent portion designed to reside in the portal vein. The device provides numerous benefits over previous stents and stent-grafts used in TIPS procedures, including being more compact to deliver, being easier to accurately deploy, a controlled compacted surface with tucked apices, an improved stent winding pattern, and being more flexible in delivery and use.

Abstract: A multilayer ingrowth matrix is constructed within well-defined porosity of a prosthetic material. The matrix consists of either proteinaceous or synthetic layers or gradients, or a combination of proteinaceous and synthetic layers or gradients. Each layer within the matrix is designed to achieve a specific function, such as facilitation of ingrowth of a particular cell type or release of a particular growth factor. The well-defined porosity is in the form of either helically oriented, interconnected transmural ingrowth channels, or a porous wall structure containing uniformly shaped pores (i.e. voids) in a very narrow size range, or a combination of channels and pores. This invention allows for uninterrupted ingrowth of connective tissue into walls of a synthetic graft prosthesis made from the prosthetic material. Furthermore, this invention can produce small diameter prostheses having an internal diameter of 6 mm or less.

Abstract: A method of making a stent includes providing a tubular member having a first layer, the first layer and the tubular member having different compositions, removing a portion of the tubular member, and removing a portion of the first layer from the tubular member.

Abstract: Disclosed is a stent having improved characteristics of its structural design and improved radiopacity characteristics. Specifically, the present invention is a stent that has circumferential sets of strut members at the ends of the stent and central sets of strut members that are longitudinally placed between the end sets of strut members. Optimal radiopacity is achieved when the end sets of strut members are more radiopaque as compared to the radiopacity of the central sets of strut members. Also disclosed is the concept of adjusting the strut width of the curved sections of the end and central sets of strut members so that equal strain in all curved sections is achieved as the stent is expanded even though the diagonals sections of the end sets of strut members are shorter than the diagonal sections of the central sets of strut members.

Abstract: A diffusion barrier for an implantable device, such as a stent, carrying a therapeutic or bioactive substance is disclosed. The diffusion barrier reduces the rate at which the therapeutic or bioactive substance is released from the device. The diffusion barrier can be made from a polymeric material impregnated with particles.

Abstract: Methods and devices are provided to facilitate the natural formation of a connection between tissue structures within the body. Certain of the subject methods provide for the formation on an anastomotic site between a graft vessel and a native vessel, such as vessels of the cardiovasculature, peripheral vasculature and neurovasculature, angiogenic, by means of facilitating angiogenic and/or arteriogenic processes at one or more selected points of contact or close proximity between the vessels. The subject devices include a mechanism for positioning or situating one vessel adjacent to another vessel, in situ, wherein a selected portion of each vessel is in contact or in close proximity with the other vessel such that a natural bond is formed between the outer tissue surfaces of the vessels at the point of contact or close proximity followed by the naturally occurring angiogenic and/or arteriogenic processes of the body.

Abstract: A collapsible stent graft for aortic aneurysms comprises a collapsible inner tubular member (26) and an outer layer (24) fused or adhered thereto such as to provide a spiral inflatable member (22) therebetween. The stent graft is inserted into an artery in the collapsed state and then expanded into position by introducing a liquid into the inflatable member and sealing the member. The graft is held in place by an expandable stent (40).