Abstract: According to an aspect of the present invention, implantable or insertable medical devices are provided which contain the following: (a) substrate having one or more depressions that contain at least one therapeutic agent and (b) a porous membrane disposed over the substrate and the one or more depressions, which regulate transport of chemical species between the therapeutic-agent-containing depressions and the exterior of the device. The substrate and the porous membrane are formed of different materials each with a different thermal expansion coefficient. Moreover, one of the substrate and the porous membrane at least partially surrounds the other. Other aspects of the present invention are directed to methods of making such medical devices, and methods of treatment using such medical devices.

Abstract: The present invention relates generally to the maintenance of blow flood using drug eluting stents and/or other coated medical devices to increased length of time of blood flow. Further, the present invention relates to drug-releasing coated devices for reducing smooth muscle cell proliferation and platelet activity to further limit restenosis utilizing resveratrol and quercetin, polyphenols that are linked to the cardioprotection of red wine consumption. The present invention also provides products and methods for treating or preventing atherosclerosis, stenosis, restenosis, smooth muscle cell proliferation, platelet cell activation and other clotting mechanisms, occlusive disease, or other abnormal lumenal cellular proliferation condition in a location within the body of a patient.

Abstract: A method of forming a stent includes the steps of forming an elongated composite member or plurality of elongated composite members into a stent pattern having struts interconnected by crowns, the composite member including an outer member and a core member. Openings are formed through the outer member of the composite member. The composite member is processed to remove the core member from at least a plurality of the struts of the stent without adversely affecting the outer member and such that the core member is not removed from at least a plurality of the crowns of the stent, thereby leaving the outer member with a lumen in at least a plurality of the struts and the outer member with the core member in at least a plurality of the crowns. The lumens may then be filled with a biologically or pharmacologically active substance.

Abstract: A tube which circumferentially distends from its initial circumference upon the application of a circumferentially distending force such as applied by an internal pressure, and which exhibits minimal recoil following the removal of the circumferentially distending force. The tube preferably has a second circumference larger than the initial circumference which remains substantially unchanged by further increasing force once it has been achieved. Because of the distensible circumference and minimal recoil of the tube, the tube is useful as a liner for pipes and vessels and particularly for pipes and vessels having irregular internal surfaces to which the tube can smoothly conform. The tube is preferably made from porous PTFE with thin walls, in which form it is particularly useful as a liner for both living and prosthetic blood vessels and to line anastomoses between living and prosthetic blood vessels.

Abstract: A mat having a highly uniform porosity distribution is produced by consolidating 15 or more layers of melt blown webs (or the like) having different orientations. Control over the porosity is provided by using webs that exhibit a narrow, unimodal distribution of fiber diameters over the bulk of its distribution, such as in the top 80%. A compliance of the mats can be chosen by selecting a number and orientation of the webs. It is thus possible to produce mats that are good candidates for vascular grafts, for example. The uniformity of the porosity within the range of 6 ?m to 30 ?m permits seeding of the vascular graft with endothelial and smooth muscle cells. The mats have the demonstrated ability to retain, and support growth of, smooth muscle cells and endothelial cells.

Abstract: Implantable medical grafts fabricated of metallic or pseudometallic films of biocompatible materials having a plurality of microperforations passing through the film in a pattern that imparts fabric-like qualities to the graft or permits the geometric deformation of the graft. The implantable graft is preferably fabricated by vacuum deposition of metallic and/or pseudometallic materials into either single or multi-layered structures with the plurality of microperforations either being formed during deposition or after deposition by selective removal of sections of the deposited film. The implantable medical grafts are suitable for use as endoluminal or surgical grafts and may be used as vascular grafts, stent-grafts, skin grafts, shunts, bone grafts, surgical patches, non-vascular conduits, valvular leaflets, filters, occlusion membranes, artificial sphincters, tendons and ligaments.

Abstract: A method for manufacturing a drug carrying stent includes applying at least a first therapeutic agent to at least an outer portion of a stent framework and applying a first magnesium coating on at least a first portion of the applied first therapeutic agent.

Abstract: The present invention provides inflatable porous implants, such as grafts, stent-grafts, and bladders, as well as methods and kits for drug delivery. In particular, the grafts and stent-grafts of the present invention provide for the delivery of a therapeutic agent into a flow conduit in the body. The inflatable porous implants provide for direct delivery of larger, more precise dosages of drugs over longer administration periods into the body. Moreover, these inflatable porous implants are often flexible when inserted and have a low profile delivery configuration for easy placement. The implants of the present invention further provide a mechanical or structural function in addition to drug delivery in a single integrated structure.

Abstract: A stent for facilitating flow between a branch of a bifurcated lumen and an interior region of the stent is provided. The stent includes proximal and distal ends and an interior region defined therethrough. The stent typically includes scaffolding having a cover applied thereto. The stent also includes at least one drainage region having at least one drainage hole defined between the scaffolding and through the cover such that fluid is capable of flowing through the drainage holes. The drainage region is typically offset from the proximal and/or distal end to facilitate fluid flow between the branch of the bifurcated lumen and the interior region of the stent.

Abstract: A drug eluting stent comprising a multilayer tubular structure which includes at least one intermediate layer having reservoirs therein for deposition of a drug, the intermediate layer eluting drug in a lateral direction, and methods of making the same.

Abstract: A stent for placement in a body lumen is fabricated by forming a tube having an un-deployed diameter sized for the tube to be placed on a deployment balloon and advanced through a body lumen to a deployment site. The tube is expandable upon inflation of the balloon to an enlarged diameter sized for the tube to be retained within the lumen at the site upon deflation and withdrawal of the balloon. The tube has a stent axis extending between first and second axial ends of the tube. The tube has an exterior surface and an interior surface. The tube is polished to polish the exterior surface to a smooth surface finish and with at least a portion of the interior surface having a rough surface finish rougher than the surface finish of the exterior surface.

Abstract: This invention is directed to graft materials for implanting, transplanting, replacing, or repairing a part of a patient and to methods of making the graft materials. The present invention is also directed to stent grafts and endoluminal prostheses formed of the graft materials. More specifically, the present invention is a graft material which includes porous polymeric sheet, extracellular matrix material (ECM) disposed on at least a portion of the porous polymeric sheet and at least one polymer layer disposed on at least a portion of the ECM. The ECM may be in a gel form. The polymeric sheet and the polymer layer may be made from foam material and may comprise a polyurethane urea and a surface modifying agent such as siloxane.

Abstract: A method of manufacturing a stent includes forming a stent blank including a predetermined alloy composition, the alloy composition including at least base element and at least one sacrificial element and forming a stent framework from the stent blank. The method further includes removing at least a portion of the sacrificial element and forming at least one pore based on the removal. A method of manufacturing a vascular treatment system includes forming a stent blank including a predetermined alloy composition including at least one base element and at least one sacrificial element. The method further includes forming a stent framework and removing at least a portion of the sacrificial element. The method also includes forming at least one pore based on the removal, bending the stent framework to a delivery shape, and attaching the bent stent framework including the formed pores to a catheter.

Abstract: An expandable medical device has elongated struts 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. At least one of the struts includes at least one opening extending at least partially through a thickness of the strut. A beneficial agent is loaded into the opening within the strut in layers to achieve desired temporal release kinetics of the agent. Alternatively, the beneficial agent is loaded in a shape which is configured to achieve the desired agent delivery profile. A wide variety of delivery profiles can be achieved including zero order, pulsatile, increasing, decrease, sinusoidal, and other delivery profiles.

Abstract: An expandable medical device having a plurality of elongated struts, the plurality of elongated struts being joined together by ductile hinges to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter. The plurality of struts and ductile hinges are arranged to improve the spatial distribution of the struts which is particularly important when delivering beneficial agents with the struts. The improved strut arrangement expands to a substantially parallelogram shape for improved beneficial agent distribution to the surrounding tissue. A beneficial agent may be loaded into openings within the struts or coated onto the struts for delivery to the tissue.

Abstract: Implants and methods of making same are provided for treatment or prophylaxis of coronary or peripheral vascular constrictions or vascular occlusions, and particularly, stenoses or restenoses, that comprise FK506 in chemically covalently bound, non-covalently bound or physically immobilized form.

Abstract: A drug eluting stent comprising a multilayer tubular structure which includes at least one intermediate layer having reservoirs therein for deposition of a drug, the intermediate layer eluting drug in a lateral direction, and methods of making the same.

Abstract: According to an aspect of the invention, medical devices are provided which include a substrate, at least one porous reservoir containing at least one therapeutic agent disposed over the substrate, at least one nanoporous layer disposed over the at least one porous reservoir, and at least one plugged aperture, which may be located within the substrate, within the nanoporous layer, or both. According to another aspect of the invention, a method of forming a medical device is provided which includes (a) forming a porous reservoir over a substrate, (b) forming a nanoporous layer over the porous reservoir, (c) forming an aperture within the substrate or the nanoporous layer, (d) filling the porous reservoir with therapeutic agent through the aperture, and (d) plugging the aperture.

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 prosthesis are matched with mechanical properties of the host vessel, thereby overcoming problems of compliance mismatch.

Abstract: The present invention relates generally to medical devices with therapy eluting components and methods for making same. More specifically, the invention relates to implantable medical devices having at least one porous layer, and methods for making such devices, and loading such devices with therapeutic agents. A mixture or alloy is placed on the surface of a medical device, then one component of the mixture or alloy is generally removed without generally removing the other components of the mixture or alloy. In some embodiments, a porous layer is adapted for bonding non-metallic coating, including drug eluting polymeric coatings. A porous layer may have a random pore structure or an oriented or directional grain porous structure. One embodiment of the invention relates to medical devices, including vascular stents, having at least one porous layer adapted to resist stenosis or cellular proliferation without requiring elution of therapeutic agents.

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

Abstract: A tracheal stent is an expandable tubular member having a proximal end, a distal end, an inner surface, and an outer surface. Circumferentially adjacent surface protrusions extend outwardly from the outer surface of the expandable tubular member. These surface protrusions have an outer surface, a first lateral surface and a second lateral surface. When the tracheal stent is deployed, the outer surface of the surface protrusion applies a radial force to a wall of the trachea to remove an airway constriction.

Abstract: The disclosure describes a coating for medical implants, in particular, vascular stents, said coating comprising silicon dioxide, towards medical implants with a coating containing silicon dioxide and towards a method for their production. The coating can contain additional admixtures and have functionalization coats. The substrate of the coating is produced from a durable material, preferably from a stainless steel.

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 medical device is provided with a porous region including a reservoir zone including a polymer and a protective zone between adjacent tissue and the reservoir zone that restricts the tissue from direct contact with the polymer.

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

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 method for bulk manufacture of a microporous sheet material from polyolefin fibers, where an average pore size in the material is controlled by calendering the material through low-energy rollers at a suitable temperature, pressure and speed. The material is useful to selectively pass or reject certain substances, and may be combined in a resilient, tube-shaped configuration to form a self-regenerating drug-delivering vascular stent that reduces inflammation at the stent site to prevent restenosis.

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: The present invention relates to a highly controlled method of preparation of a microporous biodegradable polymeric article. Firstly, at least one biodegradable polymer A, one polymer B, biodegradable or not, partially or totally immiscible with A, and a compatibilizer C for A and B are selected. Secondly, the selected polymers are melt-blended, thereby preparing a polymer blend, wherein said polymers A and B have an essentially continuous morphology. Thirdly, after cooling, polymer B and compatibilizer C are selectively extracted from the polymer blend by dissolution in a solvent that is a non-solvent of polymer A. The resulting polymeric article has an essentially continuous porosity with a void volume between 10 and 90% and a unimodal diameter distribution set to a predefined unimodal peak location. It can be used in tissue engineering, for controlled release applications or as an implantable medical device.

Abstract: An endoprosthesis such as a coronary stent includes a polymeric reservoir of drug and an over coating formed of ceramic or metal for controlling elution of drag from the reservoir.

Abstract: A medical implant that delivers therapeutic via microtubes and a method of making the same is provided. In one embodiment a biologically implantable structure adapted to fit within the body of a patient is provided. This structure may have a plurality of individual microtubes in physical communication with its outer surface, the microtubes containing or carrying a therapeutic. In another embodiment a method of manufacturing an implantable medical appliance is provided. This method includes placing a pliant stratum of microtubes onto a biologically implantable medical structure and then applying a therapeutic to the pliant stratum to cover or fill the microtubes.

Abstract: Expandable intraluminal stents are provided as well their method of manufacture. These stents are made of metal, the metal characterized by a desired porosity, with a drug compressed into the pores of the stent. The stents are formed by subjecting one or more powdered metals in a die cavity to a pressure treatment followed by a heat treatment. The metal may be cast directly in a stent-like form or cast into sheets or tubes from which the inventive stents are produced. The so-formed porous metal stent is then loaded with one or more drugs.

Abstract: A method and apparatus for reducing blood flow to an aneurysm proximate to a bifurcation having a source blood vessel a first branch vessel and a second branch vessel, the method comprising: providing a first mesh-like tube of bio-compatible material, the first mesh-like tube exhibiting a porosity index pre-selected to skew blood flow about the bifurcation away from the aneurysm; inserting the first mesh-like tube into the source blood vessel and the first branch vessel; and securing the first mesh-like tube to at least one of the source blood vessel and the first branch vessel, whereby blood flowing from the source blood vessel flows without undue impedance to the first branch vessel and the second branch vessel while being skewed away from the aneurysm.

Abstract: Amidine analogs that can inhibit the activity of sphingosine kinase 1 and sphingosine kinase 2 (SphK1 & SphK2) are provided. The compounds can prevent angiogenesis in tumor cells.

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

Abstract: A stent with strut bands and connectors, wherein the strut bands have long and short struts with a junction positioned between the short struts. Each junction defines a reservoir, wherein the reservoirs of a strut band are substantially circumferentially aligned. The connectors each have arms, wherein each arm includes an opposing U-shaped link. The opposing links have a shared portion disposed between a peak on one strut band and a longitudinally adjacent trough of an adjacent strut band.

Abstract: Disclosed herein are medical devices, such as stents, comprising a porous substrate, such as a porous ceramic. Also disclosed herein are methods for impregnating the porous substrate with a composition comprising at least one lipid and at least one pharmaceutically active agent, where the porous substrate is microporous and/or nanoporous.

Abstract: The present invention involves porous polymer membranes, suitable for use in medical implants, having controlled pore sizes, pore densities and mechanical properties. Methods of manufacturing such porous membranes are described in which a continuous fiber of polymer is extruded through a reciprocating extrusion head and deposited onto a substrate in a predetermined pattern. When cured, the polymeric material forms a stable, porous membrane suitable for a variety of applications, including reducing emboli release during and after stent delivery, and providing a source for release of bioactive substances to a vessel or organ and surrounding tissue.

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. The following manufacturing method is provided for promotion of the anti-inflammatory effect of the implant: (i) providing the body of the implant; (ii) producing an at least partially closed pore structure in a portion of the structure of the implant body close to the surface; and (iii) incorporating NOX into the cavities of the pore structure. Also described is an implant manufactured in this manner.

Abstract: Thermal spray processing and cold spray processing are utilized to manufacture porous starting materials (such as tube stock, wire and substrate sheets) from biocompatible metals, metal alloys, ceramics and polymers that may be further processed into porous medical devices, such as stents. The spray processes are also used to form porous coatings on consolidated biocompatible medical devices. The porous substrates and coatings may be used as a reservoir to hold a drug or therapeutic agent for elution in the body. The spray-formed porous substrates and coatings may be functionally graded to allow direct control of drug elution without an additional polymer topcoat. The spray processes are also used to apply the drug or agent to the porous substrate or coating when drug or agent is robust enough to withstand the temperatures and velocities of the spray process with minimal degradation.

Abstract: A machine and process useful for processing a delicate workpiece, e.g., an implantable medical device, includes a carrier having a mandrel and wheels. The work piece is positioned on the mandrel, which is free to roll by gravity on rails which cooperate with the wheels to self-align the travel of the carrier. The carrier can move the workpieces through a series of processing steps by gravity feed and without human intervention. A laterally movable carriage receives the rolling carriers and moves the carrier for processing, and returns the carrier to the rails to again roll by gravity to another processing substation for additional processing. An elevator, which can including processing units itself, is positioned along the rails to receive carriers and raise them so they can continue to roll for further processing.

Abstract: Textured surface having micro recesses such that the outer surface overhangs the micro recesses. Embodiments of the textured surface include sharp edges for promoting bone deposition and growth within the micro recesses, protrusions of varying depth from the surface that include overhangs, and micro recesses that are at least partially defined by complex ellipsoids.

Abstract: An endoprosthesis such as a coronary stent includes a luminal surface, at least a portion of which is covered with a first coating including a first drug, and an abluminal surface, at least a portion of which is covered with a second coating including a second drug. The first drug has a first eluting profile based on the first coating, and the second drug has a second eluting profile based on the second coating, the first eluting profile being different from the second eluting profile. Methods of making the same are also provided.

Abstract: The present invention consists of an implantable structural element for in vivo delivery of bioactive active agents to a situs in a body. The implantable structural element may be configured as an implantable prosthesis, such as an endoluminal stent, cardiac valve, osteal implant or the like, which serves a dual function of being prosthetic and a carrier for a bioactive agent. Alternatively, the implantable structural element may simply be an implantable article that serves the single function of acting as a time-release carrier for the bioactive agent.

Abstract: Implants with a calcium phosphate containing layer are disclosed. The implants, which can have a metallic character (e.g., made from a cobalt chromium alloy), can include a surface that is exposed to one or more formulations that results in a chemical and/or physical modification. In some instances, the modified surface is texturized so as to include a plurality of surface pits. The average pit size opening can range, for example, from 40 nm to about 10 ?m, and can include a plurality of average pit sizes in some cases. The modified surfaces can promote growth of a calcium phosphate layer, which can be accelerated relative to conventional techniques. Other variations of such implant surfaces, and methods of producing similar implant surfaces, are also discussed.

Abstract: This invention relates to biodurable, reticulated elastomeric matrices that are resiliently-compressible, their manufacture and uses including uses for implantable devices into or for topical treatment of patients, such as humans and other animals, for therapeutic, nutritional, or other useful purposes.

Abstract: An implant is proposed, in particular made from a base material including a biodegradable metal and/or a biodegradable metal alloy, wherein the implant includes a coating made of crystalline calcium phosphate and/or amorphous calcium phosphate.

Abstract: The present invention provides inflatable porous implants, such as grafts, stent-grafts, and bladders, as well as methods and kits for drug delivery. In particular, the grafts and stent-grafts of the present invention provide for the delivery of a therapeutic agent into a flow conduit in the body. The inflatable porous implants provide for direct delivery of larger, more precise dosages of drugs over longer administration periods into the body. Moreover, these inflatable porous implants are often flexible when inserted and have a low profile delivery configuration for easy placement. The implants of the present invention further provide a mechanical or structural function in addition to drug delivery in a single integrated structure.

Abstract: A hydrophilic ceramic coating is formed on an endoprosthesis preform. The hydrophilic ceramic coating is porous and can store nano-sized drug particles.