Abstract: Acceleration of the endothelialization process on implantable medical devices having at least one blood-contacting surface is achieved by a microscale pattern of sub-sections of EC-inductive coatings or EC-conductive coatings and nano/macro textured surfaces. The EC-inductive coating and EC-conductive coating can be applied either on the entire surface of the blood-contacting surface or selective placed on the blood-contacting surface, for example, in particular patterns. In this regard, the EC-conductive and EC-inductive coatings can be selectively placed relative to the textured surface to achieve a desired pattern of texture surface to coatings.

Abstract: An antimicrobial material is provided for use in forming textiles, medical devices, packaging materials, and the like, or coatings thereon. In some embodiments, the antimicrobial material may be utilized for bulk modification of an article. The antimicrobial material includes a furanone possessing vinyl and/or acrylate functional groups, optionally in combination with another monomer possessing vinyl and/or acrylate groups.

Abstract: The present disclosure is directed to a drug-eluting implantable medical devices that includes a tantalum-alloy body having a drug-eluting coating thereon for delivering a drug to treat, for example, restenosis. In an embodiment, an implantable medical device includes a body sized and configured to be implanted in a living subject. At least a portion of the body may comprise a tantalum alloy. The tantalum alloy includes a tantalum content of about 77 weight % (“wt %”) to about 92 wt %, a niobium content of about 7 wt % to about 13 wt %, and a tungsten content of about 1 wt % to about 10 wt %. The tantalum alloy exhibits at least one mechanical property modified by heat treatment thereof. The body has a drug-eluting coating thereon.

Abstract: A method and device for marking suture holes in a replacement heart valve leaflet are herein provided. The method includes providing a die having a plurality of posts, each post corresponding to suture location Ink is applied to the posts and the posts are brought into contact with the leaflet, thereby marking the locations of the suture holes on the leaflet.

Abstract: A biodegradable polymer stent with radiopacity and a method of making and using a stent with enhanced mechanical strength and/or controlled degradation for use in a bodily lumen is described.

Abstract: A stent or other prosthesis may be formed by coating a single continuous wire scaffold with a polymer coating. The polymer coating may consist of layers of electrospun polytetrafluoroethylene (PTFE). Electrospun PTFE of certain porosities may permit endothelial cell growth within the prosthesis.

Abstract: A stent includes a stent body of a cylindrical configuration having outer and inner surfaces, a first coated layer coating at least the outer surface, and a second coated layer coating substantially completely over the first coated layer. The first coated layer is prepared of a first composition comprising a polymer and a vascular intimal hyperplasia inhibitor (preferably argatroban) of a kind, which does not inhibit proliferation of endothelial cells, the weight compositional ratio of the polymer to the inhibitor being within the range of 8:2 to 3:7. On the other hand, the second coated layer is prepared of a polymer alone or a second composition comprising a polymer and a drug, the weight compositional ratio of the drug to 80% by weight of the polymer being less than 20% by weight.

Abstract: The invention relates to a medical device for delivering a therapeutic agent to a tissue. The medical device has a layer overlying the exterior surface of the medical device. The layer contains a therapeutic agent and an additive. The additive has a hydrophilic part and a hydrophobic part and the therapeutic agent is not enclosed in micelles or encapsulated in particles or controlled release carriers.

Abstract: A coating device for coating a medical device with a drug-eluting material uses an in-process drying station between coats to improve a drug release profile. The drying station includes a dryer having a telescoping plenum which provides a drying chamber for the stent or scaffold to reside while a heated gas is passed over the stent/scaffold. The drying chamber improves efficiency in drying, predictability or drug release rate, uniformity of coating material properties lengthwise over the stent/scaffold and provides a platform that can effectively support stents that are over 40 mm in length.

Abstract: A self-sealing vascular graft, including a substrate with a sealant layer and several optional additional layers, is described. The substrate can be ePTFE and the material used for the sealant and additional layers can be polyurethane. The sealant layer and additional layers may include one or more base layers, one or more foam layers, beading of different sizes and shapes, and ePTFE tape. A flared cuff may be integral to one or both ends of the substrate or may be attached to one or both ends. Various methods of making a self-sealing vascular graft are also described, including methods of disposition, methods of forming, methods of bonding and methods of attaching.

Abstract: A method of coating a stent comprises contacting a first axial portion of a stent with a support element, such that a second axial portion does not contact the support element or any other support element, applying a coating material to the second axial portion, and inhibiting or preventing application of the coating material on the first axial portion. A shuttle sheath can be used to push the stent off the support element.

Abstract: Methods of incorporating an antioxidant into a medical device including a polymer are described, and methods of packaging medical devices.

Abstract: The apparatus and method use an optical feedback system to align a brush assembly with a stent strut. Once alignment is achieved, a coating is dispensed onto the stent strut via the brush assembly and the brush assembly is moved along the stent strut to coat the stent strut.

Abstract: A flexible laminate composition and methods for manufacturing same are provided. The flexible laminate composition includes one or more discrete and separate layers of a radiopaque material wherein the radiopaque layer is applied via a solvent to a layer that is composed of a plastic material. The laminate composition can be formed into a radiopaque marker band that can be used with a medical device, such as a catheter, for radiographic imaging. The laminate composition as an alternative can also be utilized to form the catheter or other suitable medical device.

Abstract: The present invention relates to biocompatible non-woven fibrous materials having a nano-micro topography and methods for producing such materials. The materials may be used to cover implantable medical devices and to fabricate a three-dimensional drug-eluting fibrous matrix featuring accurate spatial positioning of the drug particles within the matrix.

Abstract: The invention relates to a preparation for restenosis prevention. The preparations for restenosis prevention known as yet do not reach sufficient active agent concentrations in the affected sections of the vascular walls as higher doses cause undesirable side effects. The present invention is a preparation to which at least one antihyperplastic agent is added that has a distribution ratio between butanol and water .gtoreq.0.5. The lipophilic active agent is absorbed by the vascular wall fast and in sufficient quantity. The preparation may be a liquid that can pass through capillaries and may contain a contrast agent so that the active agent is transferred into the vascular wall without any additional effort while the usually required contrast radiograms are taken. The preparation may also be applied to a catheter.

Abstract: A method for applying a coating to an implantable device is disclosed. The method includes positioning an implantable device relative to an ultrasonic material delivery apparatus. The implantable device is rotated at a relative speed. The relative speed may be more than 120 revolutions per minute. An application material is applied to the implantable device using the ultrasonic material delivery apparatus. The relative speed may be sufficient to reduce the size of at least a portion of droplets of the application material. A system for rotating an implantable device is disclosed. The system includes an implantable device and a rotation system configured to rotate the implantable device. A longitudinal axis of the implantable device and a longitudinal axis of a rotation member of the rotation system may be offset a desired dimension. An inside diameter of the implantable device may be larger than an outside diameter of a rotation member.

Abstract: A method of forming a coating on a medical device having a controlled morphology is described. A method of treating a disorder in a patient using the medical device is described.

Abstract: New ampholyte biomaterial compounds containing ampholyte moieties are synthesized and integrated into polymeric assemblies to provide hydrophilic polymers exhibiting improved biocompatibility, haemocompatibility, hydrophilicity non-thrombogenicity, anti-bacterial ability, and mechanical strength, as well as suitability as a drug delivery platform.

Abstract: A medical device having a polymer-free outer surface layer comprising a crystalline drug selected from the group consisting of everolimus, tacrolimus, sirolimus, zotarolimus, biolimus, and rapamycin. The device may be produced by a method comprising the steps of providing a medical device; applying a solution of the drug to said portion of the outer surface to form a coating of amorphous drug; and vapor annealing the drug with a solvent vapor to form crystalline drug; wherein a seed layer of a crystalline form of said drug having a maximum particle size of about 10 ?m or less is applied to at least said portion of the outer surface of the device before or after applying the drug solution, but before vapor annealing the amorphous coating.

Abstract: Coatings, devices and methods are provided, wherein the contacting surface of a medical device with at least one contacting surface for contacting a bodily fluid or tissue, wherein long-lasting and durable bioactive agents or functional groups are deposited on the contacting surface through a unique two-step plasma coating process with deposition of a thin layer of plasma coating using a silicon-containing monomer in the first step and plasma surface modification using a mixture of nitrogen-containing molecules and oxygen-containing molecules in the second step. The two-step plasma coating process enables the implantable medical device to prevent both restenosis and thrombosis under clinical conditions. The invention also relates to surface treatment of metallic and polymeric biomaterials used for making of medical devices with significantly improved clinical performance and durability.

Abstract: A method of forming a coating on a medical device having a controlled morphology is described. A medical device having a controlled morphology is described.

Abstract: A multiple stent structure including a plurality of stent bodies arranged end to end in which adjacent stent bodies of the structure are connected by a severable connecting portion disposed between the adjacent stent bodies is disclosed. A method of coating a plurality of stents including depositing a coating on the multiple stent structure and severing the severable connecting portions to disconnect the plurality of stent bodies is disclosed.

Abstract: A method of coating a stent may comprise applying a composition including a drug and a polymer to the stent to form a coating. The release rate of the drug from the coating gradually increases along a length of the stent which extends axially from opposite ends of the stent. The variable drug release rate can be accomplished by varying the coating thickness, by applying a barrier region over the drug-containing composition, and/or by having different polymers in the coating, the polymers having different drug permeabilities.

Abstract: Methods for making collagen based biocomposite constructs and related devices include: (a) winding at least one collagen fiber a number of revolutions about a length of a support member having a long axis, the winding having at least one defined pitch and/or fiber angle relative to the long axis of the support member to form an elongate construct; and (b) applying a fluid polymeric material, such as, for example, an acrylate emulsion and/or other thermoplastic material, onto the collagen fiber during the winding step. Optionally, the fluid polymeric material can include antibiotics and/or other therapeutic agents for additional function/utility.

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: Various embodiments of methods and devices for coating stents are described herein.

Abstract: An expandable medical device has a plurality of 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 plurality of 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: A drug-loaded microparticle is applied to a medical device for subsequent application to biological tissues. A method of formulating a drug-loaded microparticle and applying it to the surface of a medical device, such as a stent, is disclosed. The drug-loaded microparticle is formulated by combining a drug with various chemical solutions. Specified sizes of the microparticles and amounts of drug(s) contained within the microparticles may be varied by altering the proportions of the chemicals/solutions. In addition to various drugs, therapeutic substances and radioactive isotopes may also be loaded into the microparticles. The drug-loaded microparticle are suspended in a polymer solution forming a polymer matrix. The polymer matrix may be applied to the entire surface or only selected portions of the medical device via dipping, spraying or combinations thereof.

Abstract: A method for fixing antibody on the surface of medical instrument, mainly includes: 1) pre-treating the instrument surface; 2) preparing holes: preparing multicrystal phase structure which has same size holes in the surface of the instrument by chemical corrosion, electrochemical corrosion, anodic oxidation, micro-arc oxidation, micro-arc nitridation; 3) post-treating the instrument surface; 4) fixing the antibody: immerging the bare metal scaffold which has holes in surface into a buffer solution containing antibody, adjusting the pH value of the antibody buffer solution, fixing the antibody on the surface of the instrument by the attraction between positive and negative charge and hole effect; and 5) confirming the effectiveness of the fixed antibody by artificial simulation hemodynamics and detecting method of antibody activity in scaffold surface.

Abstract: Methods of making bioabsorbable stents with grooved lumenal surfaces for enhanced re-endothelialization are disclosed. Methods include molding grooves on the lumenal surface of coated bioresorbable and durable stents. Methods further include molding grooves on lumenal surfaces of a bioresorbable tube and forming a scaffold from the tube.

Abstract: A process for coating of implantable structures, such as stents, by using a composition which comprises at least one hydrophobin derivative (H), water and further components leads to long time usable implants.

Abstract: Medical articles with porous polymeric structures and methods of forming thereof are disclosed. The porous structure can have pores sizes that are nanoporous or greater than nanoporous. The porous structure can be a coating or layer of a medical device such as a stent, stent graft, catheter, or lead for pacemakers or implantable cardioverter defibrillators. Additionally, the body of the medical device can be a porous polymeric structure. The porous structure can be made from bioabsorbable polymers. The porous structures can be formed by contacting a polymer with a supercritical fluid.

Abstract: Medical articles with porous polymeric structures and methods of forming thereof are disclosed. The porous structure can have pores sizes that are nanoporous or greater than nanoporous. The porous structure can be a coating or layer of a medical device such as a stent, stent graft, catheter, or lead for pacemakers or implantable cardioverter defibrillators. Additionally, the body of the medical device can be a porous polymeric structure. The porous structure can be made from bioabsorbable polymers. The porous structures can be formed by contacting a polymer with a supercritical fluid.

Abstract: Medical devices, such as endoprostheses, and methods of making the devices are described. In one embodiment, a medical device having a body of interconnected bands and connectors forming an elongated tubular structure having an inner luminal wall surface, an outer abluminal wall surface and a side wall surface, and defining a central lumen or passageway, wherein said inner luminal wall surface and side wall surface of the bands and connectors form transverse passageways through the elongated tubular structure is described. One or more wall surfaces of the tubular structure can bear a coating whose selected regions define at least one depression. The coating can further include at least one biologically active substance.

Abstract: A system and method for coating an endoprosthesis involves an applicator capable of delivering a coating substance to the endoprosthesis without spraying. The applicator may have a tube or die through which a coating substance is moved upwards by capillary action or by means of a pump so as to form an accumulation of the coating substance at an upper portion of the applicator. The endoprosthesis can be lowered onto the accumulation, then axially translated or rotated in order to transfer the coating substance to selected portions of the endoprosthesis. The applicator is lowered and/or the endoprosthesis is raised in order to form gaps in the coating. Selective coating of abluminal or luminal surface of the endoprosthesis may also be performed by allowing the surface to skip on a liquid surface of a pool of the coating substance.

Abstract: A stent fixture for supporting a stent during the application of a coating substance is provided.

Abstract: A stent mounting device and a method of coating a stent using the device are provided. The mandrel is made from or is coated with a hydrophobic or hydrophilic material, depending on the type of coating composition that is employed.

Abstract: The present invention relates to method and apparatus for dispensing a beneficial agent into an expandable medical device. The method includes the step of placing an expandable medical device on a mandrel, the medical device forming a cylindrical device having a plurality of openings and dispensing a beneficial agent into the plurality of openings.

Abstract: A radially expandable prosthesis for implantation in a lumen comprises a tubular wall having an inner surface and an outer surface. The tubular wall is provided with cuts to form solid struts which have a thickness and which enables the prosthesis to expand. The solid struts have reservoirs made therethrough in the form of perforating holes for containing a therapeutic agent. The perforating holes each have an inner opening and an outer opening of substantially the same size. The prosthesis, including said perforating holes, has a smooth electrochemically polished surface.

Abstract: The invention relates to stents and catheter balloons having optimized coatings for eluting rapamycin as well as methods for manufacturing these coatings.

Abstract: A stent fixture for supporting a stent during formation of a coating is provided.

Abstract: Methods for modulating the release rate of a drug coated stent are disclosed.

Abstract: An improvement in drug-eluting stents, and method of their making, are disclosed. The surface of a metal stent is roughened to have a surface roughness of at least about 20 ?in (0.5 ?m) and a surface roughness range of between about 300-700 ?in (7.5-17.5 ?m). The roughened stent surface is covered with a polymer-free coating of a limus drug, to a coating thickness greater than the range of surface roughness of the roughened stent surface.

Abstract: The present invention proposes a method for manufacturing an implant, in particular an intraluminal endoprosthesis, having a body such that the body has metallic material. To control the degradation in a desired time window, e.g., between four weeks and six months, the following production method is performed: a) preparing the body of the implant, and b) plasma-chemical treatment of at least a portion of the surface of the body in an aqueous solution by applying a plasma-generating electric alternating voltage to the body (5) of the implant, said voltage having a frequency of at least approximately 1 kHz, to create a first layer. The invention also relates to an implant obtainable by such a method.

Abstract: The present invention relates to the regeneration, reconstruction, repair, augmentation or replacement of organs or tissue structures using scaffolds and autologous cells that are not derived from such organs or tissues.

Abstract: Provided herein is a device comprising: a. stent; b. a plurality of layers on said stent framework to form said device; wherein at least one of said layers comprises a bioabsorbable polymer and at least one of said layers comprises one or more active agents; wherein at least part of the active agent is in crystalline form.

Abstract: A method for electrostatic coating of medical devices such as stents and balloons is described. The method includes applying a composition to a polymeric component of a medical device which has little or no conductivity. The polymeric component could be a material from which the body or a strut of the stent is made or could be a polymeric coating pre-applied on the stent. The polymeric component could be the balloon wall. A charge can then be applied to the polymeric component or the polymeric component can be grounded. Charged particles of drugs, polymers, biobeneficial agents, or any combination of these can then be electrostatically deposited on the medical device or the coating on the medical device. One example of the composition is iodine, iodine, iodide, iodate, a complex or salt thereof which can also impart imaging capabilities to the medical device.

Abstract: The present invention provides a stent for implantation at a site within a human or animal body comprising: an expandable body having an inner surface and an outer surface; and treatment agents applied to the outer surface of the expandable body, the treatment agents comprising a combination of Paclitaxel and FK506 or their derivatives or analogues.

Abstract: A coated medical device and a method of providing a coating on an implantable medical device result in a medical device having a bio-absorbable coating. The coating includes a bio-absorbable carrier component. In addition to the bio-absorbable carrier component, a therapeutic agent component can also be provided. The coated medical device is implantable in a patient to effect controlled delivery of the coating, including the therapeutic agent, to the patient.