Abstract: A closable-tip fracture stent for tissue repair is disclosed. The device can be used to repair hard or soft tissue, such as bone or vertebral discs. A method of repairing tissue is also disclosed. The device comprises a flexible or semi-rigid wall, defining an interior cavity, and one or more closable tips to close the hollow cavity. A delivery tool is also provided for removably carrying the orthopedic device to the treatment site.

Abstract: Implantable medical devices adapted to erodibly release delivery media for local and regional treatment are disclosed.

Abstract: A vasoocclusive microcoil for therapeutic treatment of a patient's vasculature includes a surface with a plurality of voids or pores therein, and a therapeutic or bioactive material disposed within the plurality of voids or pores. The therapeutic or bioactive material within the plurality of voids or pores operates to accelerate a healing process in the patient's vasculature when the microcoil is introduced into the patient's vasculature.

Abstract: A method of making a drug eluting stent comprises forming a porous stent body surface layer by ion implantation, applying a layer of ceramic particles on the porous layer and compressing the layer of ceramic particles. The layer of ceramic particles can be compressed to successively higher densities. Drugs can be loaded into the layer of ceramic materials at a relatively low density before the layer of ceramic materials is compressed to a higher density to achieve a desired low drug release rate.

Abstract: The present invention relates to a process for manufacturing a porous coating with structures in the micro or nano-size domain characterized by the following steps: -providing a support having a surface, -depositing on said surface one mono-layer of temporary particles, -depositing a coating on said temporary particles in such a way that the thickness of said coating is less than the particle diameter, -eliminating said temporary particles and thereby obtaining a porous coating, the pores of said coating corresponding to the spaces previously occupied by the temporary particles and at least a part of the pores communicating with the external environment, -applying a coating fixation step, characterized by the fact that said temporary particles are deposited on said surface in such a way that, after particle deposition, more than 50% of the temporary particles are in contact with a maximum of two adjacent particles and otherwise are separated by an empty space.

Abstract: A method for treating a vascular condition includes delivering a magnesium alloy stent framework to a target region of a vessel, leaching at least a portion of magnesium from the magnesium alloy stent framework, and forming a plurality of pores within the stent framework of the stent based on the leaching.

Abstract: The invention relates to a medical device, such as an intravascular stent, useful for delivering two or more therapeutic agents to a body tissue of a patient at different rates, and methods for making and using such medical device. The medical device includes a substrate and/or coating having a plurality of pores, dispersed in said pores are a plurality of a first and second therapeutic agents, wherein said first therapeutic agent is bonded to one or more molecule(s) of a first material and the second therapeutic agent bonded to one or more molecule(s) of a second material, such that when the medical device, is in use (e.g., implanted into a body lumen such as a blood vessel), bonded first therapeutic agent is released from the medical device at a rate that is slower than the rate at which the bonded second therapeutic agent is released from the medical device.

Abstract: According to an aspect of the present invention, long term medical articles are provided which include the following: (a) first and second body contacting (e.g., tissue and/or body-fluid contacting) porous polymeric layers; (b) a polymeric barrier layer disposed between the first and second porous polymer layers; and (c) a reinforcement element. According to another aspect of the present invention, tubular medical articles for long term implantation are provided, which comprise: (a) a reinforcement element; (b) a blood contacting porous polymeric layer having a surface energy ranging between 20 and 30 dynes/cm disposed over an inner surface of the reinforcement element; and (c) an additional porous polymeric layer formed over an outer surface of the reinforcement element.

Abstract: Exemplary embodiments of the present invention relate to a stent having a supporting structure of a non-particulate inorganic carbon material.

Abstract: Exemplary embodiments of the present invention related to medical implants, such as e.g. stents are provided. For example, the implant can comprise at least one hollow space or lumen within the structural material or structure of the device, other than a pore or pore system, which may be used as a reservoir for a specific amount of active ingredient to be released after implantation into the body.

Abstract: There is described a synthetic aortic conduit formed from two tubular porous layers having a non-bioresorbable sealant, such as SEPs, interposed therebetween. The synthetic aortic conduit can be attached to an aortic valve, such as a xenograft valve, to form an aortic root replacement prosthesis. The synthetic aortic conduit has the advantage that it can be stored in the preservative solutions required for tissue valves without degradation.

Abstract: Devices, systems and methods for treating medical conditions using cell therapy via body lumens. Localized delivery is achieved with the use of a stent-like expandable body seeded with cells. The expandable body is expanded to contact at least a portion of the inner walls of the body lumen and the cells, cellular products and/or other therapeutic agents are delivered to the surrounding tissue. The therapeutic benefit provided is dependent on the type of cells used and the features of the expandable body.

Abstract: Various embodiments of the present invention provide a medical device comprising at least one blood-contacting surface comprising a porous hydrophobic polymer substrate, wherein at least a portion of the at least one blood-contacting surface comprises a hemocompatible polymer substrate. One embodiment of the present invention relates to the providing of expanded poly(tetrafluoroethylene) with one or more complexes of heparin, typically containing heparin in combination with a hydrophobic counter ion. The hemocompatible substance is dissolved in a mixture of solvents in which a first solvent wets the polymer substrate to be coated and the second solvent enhances the solubility of the hemocompatible substance material in the solvent mixture. Typical first solvents wetting a hydrophobic polymer substrate include non-polar such as hydrocholorofluorocarbons. Typical second solvents include polar solvents such as organic alcohols and ketones.

Abstract: Disclosed herein are medical devices, particularly lumen-supporting devices, which include a biocompatible nanostructured ceramic material configured to be disposed adjacent to a luminal surface and having an average grain size dimension of about 1 nanometer to about 1000 nanometers, a strain to failure of at least about 1 percent, and a cross-sectional hardness greater than or equal to about 350 kilograms per square millimeter. Also disclosed are methods of making and using the lumen-supporting devices.

Abstract: A stent has a porous surface having a repeating pattern generally in the shape of a “butterfly” comprising alternative concave and convex segments which give the stent good flexibility when unexpanded, and good shape retention once expanded.

Abstract: An expandable tissue supporting device of the present invention employs ductile hinges at selected points in the expandable device. When expansion forces are applied to the device as a whole, the ductile hinges concentrate expansion stresses and strains in-small well defined areas. The expandable medical device including ductile hinges provides the advantages of low expansion force requirements, relatively thick walls which are radio-opaque, improved crimping properties, high crush strength, reduced elastic recoil after implantation, and control of strain to a desired level. The expandable tissue supporting device includes a plurality of elongated beams arranged in a cylindrical device and connected together by a plurality of ductile hinges.

Abstract: A vasoocclusive microcoil for therapeutic treatment of a patient's vasculature includes a surface with a plurality of voids or pores therein, and a therapeutic or bioactive material disposed within the plurality of voids or pores. The therapeutic or bioactive material within the plurality of voids or pores operates to accelerate a healing process in the patient's vasculature when the microcoil is introduced into the patient's vasculature.

Abstract: Medical devices, such as endoprostheses, and methods of making the devices are described. In some implementations, the endoprostheses is a stent having a tubular body with an outer wall surface, and an inner wall surface defining a stent central lumen. One or more regions of the outer wall surface and the inner wall surfaces is formed by a porous, sintered metal layer. One or more regions of the porous, sintered metal layer provides a porous reservoir or media for drug material. The porous, sintered metal layer in one or more regions of the inner wall surface provides relatively decreased friction, increased hardness and lower tack, as compared to excipient polymeric coating material for stents, and are positioned to facilitate improved, relatively lower resistance withdrawal of a delivery balloon from the stent central lumen.

Abstract: In accordance with an aspect of the invention, implantable or insertable medical devices are provided in which a porous layer is disposed over a therapeutic-agent-containing region. In accordance with another aspect of the invention, medical devices are fabricated by a method in which a porous layer is deposited over a therapeutic-agent-containing region using a field-injection-based electrospray technique.

Abstract: A method to quantify the radial endoluminal irregularity of aortoiliac arteries is provided. Radial endoluminal outlines of a vessel of interest are determined. The cross sectional area is determined for the area outlined by each endoluminal outline. Using this cross sectional area a shape is selected that has substantially the same area as the endoluminal outline. Subsequently, the shape is fitted to the endoluminal outline. In one aspect, the irregularity index is calculated as the ratio of the endoluminal outline and the outline of the fitted shape. In another aspect, the irregularity index is calculated as the ratio of at least a part of the endoluminal outline and the outline of the fitted shape that corresponds to the same part of the endoluminal outline. The irregularity index is visualized using a color scheme, a range of numbers, or a set of labels.

Abstract: A method 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: Implantable medical endoprostheses, such as stents, are disclosed.

Abstract: The ePTFE structure includes an ePTFE structure which has a node and fibril micro-structure. The micro-structure includes specific nodes which are connected to the fibrils. One or more of the specific nodes are sintered and the fibrils are un-sintered. A method for making the ePTFE structure includes identifying and sintering one or more of the specific nodes.

Abstract: Methods for fabricating a medical device having at least one porous layer include providing a medical device having at least one alloy and removing at least one component of the alloy to form the porous layer. Although methods may be used to make stent devices with porous layers, any other suitable medical device may be made having one or more porous layers. An alloy may include any suitable combination of metals and sometimes a combination of metal and non-metal. In some embodiments, one or more of the most electrochemically active component(s) of an alloy are removed by the dissolving (or “dealloying”) process, to leave a porous matrix behind. The porous matrix layer may then be infused with one or more therapeutic agents for enhancing treatment of a patient.

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: A stent for use in animals including humans is disclosed which includes unprotected and protected regions, each protected regions including a bioactive or biopenetrating agent containing therein where the protected regions are protected by the unprotected regions when the stent is in its undeployed state which has a smaller cross-sectional dimension than the stent in its deployed state. And when the stent is in its deployed state the bioactive or biopenetrating agent(s) are brought into direct and intimate contact with a tissue or interior of a blood vessel of an animal including a human.

Abstract: An implantable stent having surface features adapted to promote an organized growth pattern of infiltrating cells when implanted in a tubular organ is provided. The surface features comprise depressions, pores, projections, pleats, channels or grooves in the stent body and are designed to increase turbulence or stagnation in the flow of a liquid, such as blood through the stent, and/or to promote the growth of infiltrating cells in an organized pattern. Alternatively, the invention stent can be populated with living cells prior to implant and can be heatable from an external source of energy, thereby inducing production of therapeutic bioactive agents from ingrowing cells. The invention also provides an implantable heatable stent for transcutaneously monitoring the flow of fluid through a lumen into which the stent is implanted by measuring the rate at which the heated stent cools in response to blood flow when the source of heat is removed.

Abstract: An improved prosthetic graft for the bypass, replacement or repair of vessels and organs that are in contact with blood flow is disclosed. The prosthetic graft includes a porous prosthetic implant and adherent cells adhered to the outer surface of the implant. The adherent cells are transfected with at least one recombinant nucleic acid molecule encoding at least one protein that enhances patency of the graft. The prosthetic graft has a long-term patency and success rate that is superior to other previously described prosthetic grafts designed for such use. Also disclosed are methods of making and using such a graft.

Abstract: Stents having struts with narrowed portions are described. The narrowed portions have a coating disposed thereon for the local delivery of a drug.

Abstract: A self-expanding endoluminal device comprising at least one tubular filamentary member having a hollow core for receiving a guidewire, the tubular member having a straightened configuration with the guidewire in the hollow core and a shape memory configuration without the guidewire in the hollow core. A delivery system includes the guidewire. The hollow core may contain a substance that is adapted to be eluted from the tubular member or permanently contained inside. The device may further comprise a graft. The device may also comprise a plurality of filamentary members, more than one of which may comprise tubular members. The device may also have a severable extension that extends outside of the body through which the substance may be periodically injected.

Abstract: A prosthesis for treating a body passage includes a micro-porous tubular element and a support element. The tubular element is formed from a thin-walled sheet having a wall thickness of 25 micrometers or less, preferably a coiled-sheet exhibiting temperature-activated shape memory properties. The mesh pattern includes a plurality of openings in the sheet having a maximum dimension of not more than about 200 micrometers, thereby acting as a filter trapping embolic material while facilitating endothelial growth therethrough. The support element includes a plurality of struts, preferably having a thickness of 100–150 micrometers. The support element is preferably an independent component from the tubular element. Alternatively, the support element may be attached to or integrally formed as part of the tubular element. The tubular and support elements are placed on a catheter in contracted conditions and advanced endoluminally to a treatment location within a body passage.

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 vascular graft prosthesis having ingrowth-permissive lumenal wall features with a thin film or layer of sealant-like material placed at a lumenal wall location to promote improved transmural tissue growth and healing.

Abstract: A method for constructing a metal wire with embedded filaments or cavities therein for biomedical applications. The method includes first drilling nonconcentric apertures in a symmetrical pattern in a metal rod and then embedding filaments in the apertures. The metal rod is then drawn and thermally-treated to form a metal wire with embedded filaments therein. The filaments may advantageously provide fatigue resistance, radiopacity, and electrical conductance to the metal wire. The method optionally provides an additional step for withdrawing or removing the filaments using various methods to create cavities for cavity access within the metal wire. The metal wire may be finished to provide access to the cavities or filaments embedded therein. The cavities may then be filled with a therapeutic drug for elution inside the human body or used for passage of body fluids.

Abstract: A vascular graft comprised of a tubular polytetrafluoroethylene (ePTFE) sheet is provided. The ePTFE sheet has a substantially uniform coating of bioresorbable gel material, for example gelatin, on a surface thereof. The coating minimises bleeding through suture holes in the ePTFE sheet and provides an increase in longitudinal extensibility.

Abstract: A prosthesis for use in preventing restenosis after angioplasty is formed of plastic or sheet metal, and is expandable and contractable for placement. The prosthesis can be inserted while in a collapsed position, then expanded and locked at the larger diameter. Spring force can be provided by the material itself, or metal springs can be embedded within the walls of the prosthesis. Preferably, the walls have holes therethrough to promote tissue growth; and, in one embodiment, the holes are in the form of slots so that the prosthesis is segmented and can bend longitudinally.

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: A porous polytetrafluoroethylene substrate is used in an endoprosthesis device. An elongate radially expandable tubular stent is also included with the porous PTFE substrate, and form the endoprosthetic device. A method of making the porous polytetrafluoroethylene entails a novel method including siloxane in PTFE and thereafter removing the siloxane to form the porous structure. The PTFE structure does not have nodes and fibrils.

Abstract: An expandable stent includes a tubular structure with an outer surface positionable adjacent to a vessel wall and an inner surface facing a lumen of a body passageway. The tubular structure further includes a plurality of expansion struts, connector struts and cells. The tubular structure has a first diameter which permits intraluminal delivery of the tubular structure into the body passageway, and a second expanded and deformed diameter which is achieved upon the application of a radially, outwardly extending force. A plurality of cavities are formed in the outer surface of the stent.

Abstract: A stent of variable surface area as determined by stent struts. The stent can have a variable surface area per unit length which accommodates a therapeutic agent. A patterned distribution of therapeutic agent can be provided throughout the stent. The stent can have an increased level of therapeutic agent near an end of the stent. A decreased level of therapeutic agent can be provided near an end of one embodiment of a stent. Indentations can be provided at the surface of the stent with therapeutic agent disposed therein. The stent can be cut with struts of variable thickness to provide the variable stent surface area.

Abstract: A two-layered fenestrated vascular graft is provided for repair of diseased, damaged or aneurismal blood vessels. The fenestrated vascular graft is configured to be delivered transluminally and implanted within the lumen of a native blood vessel using catheter-based minimally-invasive surgical techniques. The vascular graft is fenestrated or perforated to facilitate making a fluid connection or anastomosis with one or more of the sidebranches of the vessel into which it is implanted. The vascular graft is adapted for implantation into blood vessels, such as the aorta, having tributary vessels or sidebranches along the section of the blood vessel to be repaired without occluding or obscuring the sidebranches. Methods are described for implanting the vascular graft into a patient's aorta for repairing thoracic or abdominal aortic aneurysms and for making a fluid connection or anastomosis with the tributary vessels or sidebranches of the aorta, such as the renal, hepatic and mesenteric arteries.

Abstract: An implantable device for positioning about a blood vessel bifurcation zone to control flow of embolic material around said bifurcation. The device comprises an anchoring element extending within said zone of bifurcation to anchor said device therein, and a deflecting element, associated with said anchoring element, said deflecting element comprising a mesh having a mesh size sufficient to allow passage of blood without hindrance while occluding passage of embolic material exceeding a predetermined size.

Abstract: A endovascular prosthesis for implantation in a body passageway. The prosthesis comprises a tubular wall which is: (i) movable between a first longitudinal length and a second longitudinally length, and (ii) radially expandible for implantation of the prosthesis in the body passageway. In one embodiment, the tubular wall has a longitudinally length which is variable by an “accordian”-like action. In another embodiment, the tubular wall has a longitudinally length which is variable by an “telescoping”-like action. The longitudinal length of the tubular wall may be varied in vivo to optimize deployment of the endovascular prosthesis.

Abstract: An improved prosthetic graft for the bypass, replacement or repair of vessels and organs that are in contact with blood flow is disclosed. The prosthetic graft includes a porous prosthetic implant and adherent cells adhered to the outer surface of the implant. The adherent cells are transfected with at least one recombinant nucleic acid molecule encoding at least one protein that enhances patency of the graft. The prosthetic graft has a long-term patency and success rate that is superior to other previously described prosthetic grafts designed for such use. Also disclosed are methods of making and using such a graft.

Abstract: The invention relates to an implant and a method for the production of an implant. The implant has a covering layer that is preferably made of aluminium oxide and provided with uniform cavities and separate openings on the surface side of the covering layer in order to receive a therapeutic agent which can be released according to requirements when the implant is in place.

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: A vascular prosthesis is constructed from a well-defined pore structure to allow uninterrupted ingrowth of connective tissue into a wall of the prosthesis. Several different methods can be used to produce the prosthesis, including a vacuum impregnation technique, a paste molding technique, a paste extrusion technique, a dip coating technique, and a melt extrusion technique. Furthermore, mechanical properties of the prosthesis are matched with mechanical properties of the host vessel, thereby overcoming problems of compliance mismatch.

Abstract: A vascular or endoluminal stent is adapted to be implanted in a vessel, duct or tract of a human body to maintain an open lumen at the site of the implant. The sidewall of the open-ended tubular structure of the stent is a base layer of a metal biologically compatible with blood and tissue of the human body. An intermediate metal particle layer of substantially greater radiopacity overlies the base layer, with particles bonded to the base layer and to each other to leave interstices therebetween as a repository for retaining and dispensing drugs or other agents for time release therefrom after the stent is implanted, to assist the stent in maintaining the lumen open. The particles are composed primarily of a noble metal—an alloy of platinum-iridium. The sidewall has holes extending therethrough, and the particle layer resides along the outward facing and inward facing surfaces, and the edges of the through holes and open ends of the sidewall.

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: The expandable stent-graft generally defines a cylindrical lumen made from a stent having a discontinuous wall that is at least substantially covered with an expended polytetrafluoroethylene material. The expanded polytetrafluoroethylene covering may be a biaxially oriented, expanded polytetrafluoroethylene material having nodules and longitudinal and circumferential fibrils or a uniaxially oriented, expanded polytetrafluoroethylene material. The expandable stent-graft expands and compresses in association with the stent structure as it is contracted and expanded.