Abstract: A process for depositing an active substance on selected regions of the surface of a stent, comprising: (i) providing the active substance in at least one form selected from the group consisting of a powder and a paste; and (ii) depositing the active substance on the selected regions of the surface of the stent. Preferably, the active substance comprises or consists essentially of FK506, such as FK506 in the form of a powder with a grain size smaller than 15 micron or a paste with a base of FK506 with a viscosity not lower than 100,000 to 120,000 cps.

Abstract: A bioerodible endoprosthesis erodes by galvanic erosion that can provide, e.g., improved endothelialization and therapeutic effects.

Abstract: The present invention is generally directed to implantable medical devices for delivering therapeutic agents to the body tissue of a patient and methods for making such medical devices. In particular, the present invention is directed to implantable medical devices, such as intravascular stents, having a surface that includes a plurality of cavities and a plurality of pores and a composition disposed in the pores and/or cavities, as well as, implantable medical devices, such as intravascular stents, having a surface that has a coating composition disposed on the surface, wherein the coating composition includes a plurality of cavities and a plurality of pores and another coating composition disposed in the pores and/or cavities.

Abstract: A drug elution stent includes a stent framework and a drug elution portion disposed on the stent framework. The drug elution portion includes a first sugar layer disposed on the stent framework, at least one therapeutic agent layer disposed on the first sugar layer and a second sugar layer disposed on the at least one therapeutic agent layer. A method of manufacturing a drug elution stent includes the steps of providing a stent having a stent framework and coating at least a portion of the stent framework with a drug elution portion. The drug elution portion includes a first sugar layer disposed on the stent framework, at least one therapeutic agent layer disposed on the first sugar layer and a second sugar layer disposed on the at least one therapeutic agent layer.

Abstract: A vascular stent comprising a drug-eluting outer layer of a porous sputtered columnar metal having each column capped with a biocompatible carbon-containing material is described. This is done by placing the stent over a close-fitting mandrel and rotating the assembly in a sputter flux. The result is a coating that is evenly distributed over the outward-facing side of the stent's wire mesh while preventing the sputtered columnar coating from reaching the inward facing side where a smooth hemocompatible surface is required. The stent is then removed from the mandrel, exposing all surfaces, and finally coated with a layer of carbon such as amorphous carbon or diamond-like carbon. The carbonaceous coating enhances biocompatibility without preventing elutriation of a therapeutic drug provided in the porosity formed between the columnar structures. The result is a stent that is adapted to both the hemodynamic and the immune response requirements of its vascular environment.

Abstract: A prosthesis including a support structure for enhancing kink and/or crush resistance. The support structure is connected to an outer surface of the prosthesis and includes at least two components, one of which has a lower melting point than the other. The component with the lower melting point is used to connect the support structure to the outer surface of the prosthesis.

Abstract: Implantable medical devices may include at least one structural element having an abluminal side, luminal side, and sidewalls between the abluminal and luminal sides. The coating may include at least two continuous coating layers. In some embodiments, the luminal side, and all or a majority of the sidewalls are free of at least two of the coating layers.

Abstract: In embodiments, a stent comprises a biodegradable polymer functionalized with an adhesion-enhancing amino acid.

Abstract: A bioerodible endoprosthesis erodes to a desirable geometry that can provide, e.g., improved mechanical properties or degradation characteristics.

Abstract: A vascular stent comprising a drug-eluting outer layer of a porous sputtered columnar metal having each column capped with a biocompatible carbon-containing material is described. This is done by placing the stent over a close-fitting mandrel and rotating the assembly in a sputter flux. The result is a coating that is evenly distributed over the outward-facing side of the stent's wire mesh while preventing the sputtered columnar coating from reaching the inward facing side where a smooth hemocompatible surface is required. The stent is then removed from the mandrel, exposing all surfaces, and finally coated with a layer of carbon such as amorphous carbon or diamond-like carbon. The carbonaceous coating enhances biocompatibility without preventing elutriation of a therapeutic drug provided in the porosity formed between the columnar structures. The result is a stent that is adapted to both the hemodynamic and the immune response requirements of its vascular environment.

Abstract: An implant comprising an implant material forming a base made of one or more metallic elements; a diffusion layer covering the base made of at least one of the metallic elements of the implant material and at least magnesium; and, optionally, a metal layer covering the diffusion layer made of magnesium or a biocorrodible magnesium alloy.

Abstract: The invention provides an implantable medical device comprising a fibrous polymer body comprising a plurality of electrospun poly(urethane) fibers, a support filament wrapped around the body, an outer layer around the filament for adhering the filament to the body, the outer layer comprising a plurality of electrospun poly(urethane) fibers, and a polymer primer coating at least the fibers of the body. The polymer primer comprises poly(lactide) and is attached to a heparin residue through a link.

Abstract: A bioabsorbable stent including a stent scaffolding formed from polymer layers with different degradation rates is disclosed. The polymer layers include an abluminal layer, a luminal layer, and optionally one or more middle layers. A degradation rate of the layers increases from the luminal layer to the abluminal layer.

Abstract: An implantable flow restrictor plug is disclosed that is disposed within a deployed endoluminal prosthesis to initially restrict, then gradually restore blood flow through the prosthesis after an angioplasty procedure. Upon initial deployment, the plug has a tubular biodegradable body defining a blood flow lumen therethrough that is sized to effectively reduce the amount of blood flow exiting the prosthesis. An inner surface of the body erodes or biodegrades in vivo to enlarge the plug lumen, thereby gradually restoring blood flow through the prosthesis until blood flow is unimpeded through the prosthesis, i.e., blood flow through the vessel is fully restored. The flow restrictor plug may be attached to the endoluminal prosthesis to be delivered and deployed therewith, or may be formed within a previously deployed prosthesis.

Abstract: Medical devices, such as endoprostheses, and related methods are disclosed.

Abstract: Universal modular stented graft assemblies are assembled, on site, and often in a patient's parent artery, from at least two components; a first component and a second component. The first and second components each include a window, or fenestration. The second component couples with the first component by fitting at least partially in the first component to form the universal modular stent graft assembly with an adjustable collateral opening. As the first and second components are assembled, the first and second components are adjusted relative to each other so that the first and second component windows overlap to form a collateral opening whose size is selectable, depending on the overlap, with the desired position and dimensions in the universal modular stent graft assembly.

Abstract: A vascular stent comprising a drug-eluting outer layer of a porous sputtered columnar metal having each column capped with a biocompatible carbon-containing material is described. This is done by placing the stent over a close-fitting mandrel and rotating the assembly in a sputter flux. The result is a coating that is evenly distributed over the outward-facing side of the stent's wire mesh while preventing the sputtered columnar coating from reaching the inward facing side where a smooth hemocompatible surface is required. The stent is then removed from the mandrel, exposing all surfaces, and finally coated with a layer of carbon such as amorphous carbon or diamond-like carbon. The carbonaceous coating enhances biocompatibility without preventing elutriation of a therapeutic drug provided in the porosity formed between the columnar structures. The result is a stent that is adapted to both the hemodynamic and the immune response requirements of its vascular environment.

Abstract: A medical device may comprise a body portion and an outwardly deployable side branch structure, and may be formed from a first stent and a second stent. In some embodiments, the first stent and second stent may be connected by at least one connection. At least a portion of the second stent may be oriented within the first stent and may be coaxially aligned with the first stent. Either stent may include the side branch structure, and the stent not having side branch structure may include a side branch opening. The first and second stents may overlap at various locations to provide additional vessel support.

Abstract: A double-tube type stent is inserted into a hollow tubular organ such as a bile duct so as to relieve narrowing of the bile duct on, for instance, an anastomotic area of the intrahepatic bile duct of a liver transplant patient. A hollow cylindrical body has a plurality of rhombic spaces formed by weaving a superelastic shape-memory-alloy wire so as to be crossed. A silicon coating layer is coated on an outer surface of the cylindrical body using a silicon solution. A polytetrafluoroethylene (PTFE) tube is fixedly fitted around the cylindrical body having the silicon coating layer leaving a gap therebetween.

Abstract: A prosthetic implantable device that offers a reduction in fluid loss when the device is punctured, such as by a dialysis needle or suture needle, and the needle is subsequently removed. The device may be made to be thin and flexible, and with longitudinal stretch, in order that it also offers good handling and kink resistance to a surgeon. While the device is preferably of tubular form, flat sheets or other forms may also be made. The device includes inner and outer layers of a porous material having a microstructure of nodes interconnected by bent fibrils, and having void spaces between adjacent bent fibrils. The inner and outer layers are joined by an elastomeric adhesive that may interpenetrate the void spaces of the adjacent surfaces of the inner and outer layers, that is, the inner surface of the outer layer and the outer surface of the inner layer.

Abstract: Disclosed is a stent comprising a bioabsorbable polymeric scaffolding; and a plurality of depots in at least a portion of the scaffolding, wherein the plurality of depots comprise a bioabsorbable material, wherein the degradation rate of all or substantially all of the bioabsorbable polymer of the scaffolding is faster than the degradation rate of all or substantially all of the bioabsorbable material of the depots.

Abstract: A porous prosthesis for delivering a medication to the site of implantation. The prosthesis, such as a stent, includes a first porous region and a second porous region and is at least partially formed from a molybdenum-rhenium alloy. The porous regions can have different porosity. A stent includes first, second and third porous region, the first porous region being between the second and third porous regions, and a therapeutic agent is disposed in the first porous region. A stent can also include a solid core and inner and outer porous layers surrounding the core.

Abstract: Endoprostheses such as stents are disclosed that are, or that include portions that are, bioerodible.

Abstract: Medical devices, for example, implantable devices such as endoprostheses, include a composite material having a polymer.

Abstract: An implantable drainage device for treatment of a stricture of a body vessel is disclosed. The device comprises a drainage tube including an inlet and extending to an outlet to define a drainage lumen formed through the inlet and the outlet. The drainage tube includes a swell layer and a cast layer formed about the swell layer. The swell layer has a first agent dispersed thereabout for regulated drug elution through the cast layer. The cast layer has a second agent disposed thereabout for drug elution therefrom.

Abstract: Disclosed are implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particular, the invention discloses implantable or insertable medical devices that comprise at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and/or a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device. Also disclosed are methods of manufacturing such devices under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of the biocompatible matrix polymer and substantially prevent chemical modification of said bioactive agents.

Abstract: A method for modifying a polymeric coating on an implantable medical device, such as a stent, is disclosed. The method includes application of a fluid to a wet or dry polymeric coating with and without drugs.

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: An endoprosthesis includes a plurality of struts defining a flow passage. At least one strut includes (a) a body comprising a bioerodible material and having a thickness and (b) a coating overlying the body. The coating includes a plurality of regions that allow physiological fluids to contact a plurality of corresponding areas of the underlying body when the endoprosthesis is implanted in a physiological environment. The plurality of regions are sized and arranged so that the contacted areas of the body erode substantially through the body in the thickness direction while the coating remains on the body when the endoprosthesis is implanted in the physiological environment.

Abstract: A bioabsorbable blend comprising poly(L-lactide) (PLLA) and a phosphorylcholine group-containing copolymer (PPCP) capable of enduring the mechanical strength of blood vessel walls and applicable for fabricating cardiovascular devices was developed. The blend acts as a scaffold to support blood vessel walls during vascular healing and undergoes biodegradation in vivo after vascular healing is complete. Furthermore, the blend can prevent the formation and adsorption of thrombi.

Abstract: An endoprosthesis that includes a composite having a metal matrix and a plurality of stiffening particles in the matrix. The metal of the metal matrix can include titanium, niobium, tantalum, or alloys thereof. The stiffening particles can include a metal core and a thin surface layer. The thin surface layer can include oxides, carbides, nitrides, or combinations thereof.

Abstract: There is disclosed a method for introducing a helical formation (11) into a flexible tubular material (12). The material (12) is supported together with a surrounding helical former (13) so as to deform the material (12) to have a helical indentation (11) corresponding to the shape of the former (13). The material (12) is then set in that configuration and the former (13) is removed.

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: Medical devices, such as endoprostheses, and methods of making the devices are disclosed. The medical device can include a composite cover formed of a deposited metallic film. The cover may include one or more filaments, e.g., wires, which cooperate with the film to provide desirable mechanical properties. The wires may be integrated with the film by depositing the film over the wires.

Abstract: A stent is formed by encasing or encapsulating metallic rings in an inner polymeric layer and an outer polymeric layer. At least one polymer link connects adjacent metallic rings. The stent is drug loaded with one or more therapeutic agent or drug, for example, to reduce the likelihood of the development of restenosis in the coronary arteries. The inner and outer polymeric materials can be of the same polymer or different polymer to achieve different results, such as enhancing flexibility and providing a stent that is visible under MRI, computer tomography and x-ray fluoroscopy.

Abstract: A laminated stent encapsulated with a metal coating is provided. The metal coating may be a very thin metal coating. Portions of the metal coating may be removed such that the metal coating covers voids in the laminate, particularly in the area where the different layers of the laminated stent come together. The metal coating for the laminated stent may be provided by sputtering, such as vacuum deposition or ion beam sputtering, spraying, dipping, or other known methods.

Abstract: Various embodiments of stents with a bioabsorbable body having a coating with a radiopaque layer are disclosed.

Abstract: The present invention provides multilayered materials, such as films usable in particular in medical devices in the form of vascular grafts, biocompatible coverings, and/or inflatable bladders, prosthesis for the endoluminal treatment of aneurysms, particularly aortic aneurysms including both abdominal aortic aneurysms (AAA's) and thoracic aortic aneurysms (TAA's).

Abstract: Bioresorbable medical implants are designed to have different resorption rates over time or over the topography of the implants. The resorption of the medical implants are controlled by including layers having differing resorption rates. The layers resorb sequentially over time through sequential exposure to body fluids. A resorption-controllable medical implant includes a series of two or more layers. The first layer includes a first bioresorbable material. The second layer includes a second bioresorbable material and resorbable particles of a first kind dispersed within the second bioresorbable material. Additional layers of bioresorbable material alone or including resorbable particles may be added to slow or speed resorption and achieve desired control over the resorption of the implant. Resorbable particles can be added in differing amounts or kinds in various segments of the implant to provide topographically differing resorption rates.

Abstract: An artificial blood vessel includes an artificial blood vessel body layer and a silicone layer. The artificial blood vessel body layer comprises an injection section, and the silicone layer is covered and mounted on an outer surface of the injection section. The artificial blood vessel body layer and the silicone layer are formed integrally by injection-molding. The silicone layer covered and mounted on the injection section of the artificial blood vessel body layer enables the artificial blood vessel for repeated injections and effectively prevents puncture aneurysm from occurring.

Abstract: A porous prosthesis for delivering a medication to the site of implantation, and a method of making the same, is disclosed.

Abstract: A vascular prosthesis having a tubular structure is provided. The tubular structure is fabricated from at least two layers wherein at least one layer includes a thrombogenic agent.

Abstract: The present invention relates to a method for manufacturing an implant, in particular an intraluminal endoprosthesis, having a body containing metallic material, preferably iron. For controlling the degradation of the implant the method includes the following steps: (a) providing a first part of the implant body; and (b) performing heat treatment which alters the carbon content and/or the boron content and/or the nitrogen content in the structure of a near-surface boundary layer in the first part of the implant body in such a way that strain on the lattice or a lattice transformation, optionally following a subsequent mechanical load, is achieved in the near-surface boundary layer. Such an implant is also described.

Abstract: The invention relates generally to expandable medical implants for maintaining support of a body lumen and, in particular, to an axially nested, diametrically expandable, slide and lock vascular device for enlarging an occluded portion of a vessel. The axially nested vascular device desirably achieves both competitive crossing profiles while maintaining other key features, such as, for example, radial strength and luminal patency. The collapsed profile can also be made very thin without compromising radial strength. Thus, the vascular device can advantageously be deployed in small and difficult to reach areas or vessels. The axial nesting substantially eliminates radial overlap between mating structural elements thereby desirably allowing for a low, uniform profile.

Abstract: A stent-graft which is particularly useful for applications in biliary ducts. An expandable stent is provided with a covering of a material which is substantially impervious to body fluids and tissue ingrowth and has an increased resistance to bacterial attachment due to its lack of porosity and reduced surface texture. A preferred covering is porous PTFE film rendered substantially non-porous by a coating of a polymeric material such as FEP. The resulting stent has a thin wall for minimum pre-deployment diameter and for minimum interference with fluid flow through the device after implantation. It has good flexibility, allowing its use in curved ducts.

Abstract: Methods and compositions are disclosed for coating a biocompatible medical implant with a surface layer having antioxidant activity. In various embodiments, a surface layer described herein destroys the oxidative activity of a reactive oxygen species (ROS) upon contact. An ROS can be, for example, an ROS generated by neutrophils in vivo. In various embodiments, a surface layer comprises a titanium oxide layer that can comprise a rutile, an anatase or a perovskite crystal structure, and can include defects comprising Ti(III). In some embodiments, the oxide layer can further comprise a dopant such as niobium. In some embodiments, methods for forming a surface layer on a biocompatible medical implant having antioxidant activity are disclosed.

Abstract: An expandable medical device having a plurality of elongated struts, the plurality of elongated struts being joined together to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter, and the plurality of struts each having a strut width in a circumferential direction. At least one of the plurality of struts includes at least one opening extending at least partially through a thickness of the strut. A beneficial agent may be loaded into the opening within the strut. The expandable medical device may further include a plurality of ductile hinges formed between the elongated struts, the ductile hinges allowing the cylindrical device to be expanded or compressed from the first diameter to the second diameter by deformation of the ductile hinges.

Abstract: A stent includes a tubular stent body 11, a diamond-like carbon film 12 formed on the surface of the stent body 11 and having an activated surface, and a polymer layer 13 immobilized on the surface of the diamond-like carbon film. The polymer layer 13 contains a drug 14 having an effect to prevent restenosis, and the drug 14 is gradually released from the polymer layer 13.

Abstract: There is provided a thin-walled self-sealing vascular graft with a first tubular structure formed from ePTFE and having a wall thickness of 0.2 mm or less, and a resealable polymer layer, such as a styrene copolymer, located on one surface of said first tubular structure. A second tubular structure may also be present, so that the resealable polymer layer is disposed between said first and second tubular structure. The second tubular structure is preferably formed from a textile layer but can also be ePTFE. The graft can be used for replacing a defective portion of the vasculature in a patient in need thereof.

Abstract: Methods of fabricating a stent and a stent having selected morphology on abluminal and luminal surfaces of the stent are disclosed.