Abstract: One example embodiment of the present invention relates to an implant, particularly an intraluminal endoprosthesis, having a body that contains metallic material, preferably iron. The implant body has a first layer with at least one ionic compound that contains ions of at least one halogen, particularly chloride ions and/or bromide ions, on at least part of its surface. Furthermore, a method for the production of such an implant is described.

Abstract: Water-soluble polymeric adhesive compositions and their use as delivery vehicles for carrying therapeutic agents on implantable devices, such as vascular grafts, are disclosed. Use of drug-coated vascular grafts is demonstrated for delivery of the therapeutic agents in vivo, thereby inhibiting restenosis or neointimal hyperplasia of the vascular graft and inhibiting infection at the vascular graft site. Methods of forming the adhesive and making the coated vascular grafts are also disclosed.

Abstract: This invention relates to methods of including an oxygen-sensitive macrocyclic triene on an implantable medical device wherein the device includes separate antioxidant-containing layers above, below or both above and below the drug reservoir layer containing the macrocyclic triene.

Abstract: Stents with coatings comprising a combination of a restenosis inhibitor comprising an HMG-CoA reductase inhibitor and a carrier. Also provided are methods of coating stents with a combination of an HMG-CoA reductase inhibitor and a carrier. A preferred example of a restenosis inhibitor is cerivastatin. The stent coatings have been shown to release restenosis inhibitors in their active forms.

Abstract: The present invention relates to a catheter balloon with a coating containing rapamycin and shellac and to a method for coating catheter balloons preferably textured catheter balloons with the pharmacological agent rapamycin, shellac and optionally further components. Moreover, the present invention relates also to the use of catheter balloons coated in such a way for the release of the pharmaceutically active agent rapamycin for prophylaxis and treatment of restenosis, preferably restenosis caused by angioplasty. The coated catheter balloons can be used alone or in combination with a coated or uncoated stent, which is crimped on the catheter balloon before or after the coating with shellac and rapamycin.

Abstract: The present invention provides a coating comprising a reservoir layer comprising a terpolymer comprising caprolactone and glycolide and a primer layer comprising an amorphous polymer on an implantable device and methods of making and using the same.

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: Disclosed herein are biocompatible coatings for a substrate, the biocompatible coating including at least one polyanionic/polycationic bilayer including at least one nitric oxide generating moiety, wherein the polyanionic/polycationic bilayer has a layer of a polycationic polymeric material; and a layer of polyanionic material capable of non-covalently bonding to the polycationic polymeric material. Devices incorporating such coatings, and methods of making and using such coatings are also disclosed herein.

Abstract: The present invention provides a coating comprising a reservoir layer comprising a terpolymer comprising caprolactone and glycolide and a primer layer comprising an amorphous polymer on an implantable device and methods of making and using the same.

Abstract: Methods for coating medical devices for implantation within a body vessel are provided comprising providing a cylindrical container, placing a medical device inside the cylindrical container, and applying a polymer in liquid form inside the container.

Abstract: A method for fabricating an embodiment of a medical device comprising the steps of: preparing a biodegradable polymeric structure; coating the biodegradable polymeric structure with a polymeric coat including a pharmacological or biological agent; cutting the structure into patterns configured to allow for crimping of the cut structure and expansion of the cut structure after crimping into a deployed configuration.

Abstract: A method of a forming a hollow, drug-eluting medical device includes utilizing a hollow wire having an outer member and a lumen of the outer member, and filling the lumen with a fluid to form a supported hollow wire. The supported hollow wire is shaped into a stent pattern. Openings are formed through the outer member. The supported hollow wire is processed to remove the fluid from the lumen of the outer member without adversely affecting the outer member, leaving the hollow wire shaped into a stent pattern. The lumen is filled with a biologically or pharmacologically active substance.

Abstract: A coating method and a coating apparatus are used to apply coating material to struts of a medical device (e.g., stent) which bound openings. The method involves optically scanning the medical device to produce position information identifying positions of the struts, using the position information to calculate a predetermined position, setting an applying manner to apply the coating material based on the predetermined position, setting an applying path accommodating the applying manner, and relatively moving the medical device and an applicator head along the applying route and path while dispensing the coating material from the applicator head and applying the coating material to the struts.

Abstract: The present invention provides an absorbable coating for an implantable device and the methods of making and using the same.

Abstract: A coated stent (20) for use in a medical procedure and methods of manufacturing the coated stent (20) are described. A stent component (30) has an expanded state in which an inner diameter (ds) of the stent (30) is less than or equal to an outer diameter (dc2) of a coating (40), thereby causing an inner surface (35) of the stent (30) to engage the outer surface (42) of the coating (40). In one exemplary method of manufacture, the stent (30) is disposed over the coating (40) when the coating (40) is provided with a first, smaller outer diameter (dc1). The coating (40) then is radially expanded to a second, larger outer diameter (dC2), which is greater than or equal to the inner diameter (ds) of the stent (30), to cause the outer surface (42) of the coating (40) to engage the inner surface (35) of the stent (30).

Abstract: The present invention relates to the design and development of a drug delivery nanoplatform that consists of nanoporous, multi-layer biodegradable polymeric (BP) thin films for controlled release of its payload. The method is used notably to synthesize nanoporous BP coatings as drug delivery vehicles exhibiting uniform nanopores with tailored characteristics for control of drug delivery and release. It enables the multiplex delivery of drugs that can be eluted at desirable time intervals in line with each medical need. Atomic Force Microscopy and Spectroscopic Ellipsometry are applied for determining nanoporosity, thickness, drug loading, structural properties, and quality of the BP films ensuring the quality control of the final product. The complete degradation of the polymers minimizes the toxicity within the human body and such nanoplatform can be used in a wide range of drug eluting and other medical implants and biomedical devices.

Abstract: A stent, the stent comprising a first coating composition comprising at least one bioadhesive and a second coating composition disposed over the first coating composition, the second coating composition comprising at least one biodegradable polymer.

Abstract: The present disclosure is directed to a class of fluorinated copolymers, such as a PTFE copolymers, that can be dissolved in low toxicity solvents, such as Class III Solvents, and that enable the creation of stable water-in-solvent emulsions comprising the fluorinated copolymers dissolved in a low toxicity solvents and a hydrophilic agent (e.g., a therapeutic agent) dissolved in an aqueous solvent, such as water or saline.

Abstract: A bioabsorbable tracheal stent is provided. The bioabsorbable stent comprises a biodegradable polymer, wherein the “ biodegradable polymer comprises about 0 to 30 wt % glycerol, polyethylene glycol, triethyl citrate, or mixture thereof. A drug is dispersed within or dissolved in the biodegradable polymer. In a second and third aspect, the invention relates to methods of manufacturing a bioabsorbable tracheal stent. The first method includes forming a solution comprising a biodegradable polymer and a drug, the biodegradable polymer comprising about 0 to 30 wt % glycerol, polyethylene glycol, triethyl citrate, or mixture thereof. The method further comprises casting the solution to form the bioabsorbable tracheal stent.

Abstract: The present invention provides a coating comprising a reservoir layer comprising a semi-crystalline polymer and a primer layer comprising an amorphous polymer on an implantable device and methods of making and using the same.

Abstract: A coating and drying apparatus for the application of a coating substance to a stent and drying the stent is provided.

Abstract: A catheterization device that may be designed by use of an adaptive genetic algorithm computational fluid dynamics approach, as well as other Global Optimization methods that may include simulated annealing, multistart and interval methods, continuous branch and bound methods, evolutionary algorithms, and tabu search and scatter search methods, as well as other available Global Optimization methods that is able to maximize/optimize the dwell time of an infused agent in the vicinity of a vascular lesion. The device may have an internal by-pass channel that allows the blood upstream of the lesion to continue its pulsatile flow through the vessel in the part of it occluded by the lesion, while simultaneously allowing the disbursement and maximal dwell time of an antithrombolytic or other diagnostic or therapeutic agent needed to treat the lesion.

Abstract: Scaffold-supported metal or pseudometallic film covers suitable for use as medical devices are disclosed together with methods of fabricating the devices. Methods for making the medical devices consist of either providing or forming a scaffold, then depositing a metallic or pseudometallic film cover onto the scaffold in such a manner as to form an integral, substantially monolithic junction between the deposited cover material and the scaffold.

Abstract: A systems and method for reducing coating defects on a stent may involve a support apparatus comprising wire cage for carrying a stent. The support apparatus may have no structure that extends inside the stent. A support apparatus may include a plurality of wires that pass through the stent but do not pass through the midplane of the stent. A support apparatus may contact only the proximal ends of the stent. The method may involve keeping the stent in motion during a spray coating process to prevent the stent from having a point remain in continuous contact with a support apparatus.

Abstract: A method of manufacturing a stent includes applying a coating to the stent and changing an amount of the coating being applied to the stent by modifying the diameter of the stent.

Abstract: Methods of fabricating a bioresorbable polymer scaffold are disclosed including a step of inducing crystallization in a bioresorbable polymer construct through exposure to a liquid penetrant.

Abstract: Methods of coating a stent are disclosed. In one example, the method includes positioning the stent on a support element configured to support the stent while rotating the stent. The support element has at least three elongate elements converging inwardly from a proximal end to a distal end of each element to form a conical or frusto-conical shape. The support element can be configured to be positioned within an end of the stent. The stent can be pinched between the support element and a second support element. A coating composition is applied to the stent. The method can further include pulsing the support element and/or the second support element to change a contact position of the stent with respect to the support element or the second support element; rotating the support element and the second support element at two different rates; or translating the support element from a first point of contact with the stent to a second point of contact with the stent.

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

Abstract: The disclosure relates to a method for coating a target. The method includes providing a target and an electrospinning apparatus. The target comprises a first surface and an opposing second surface. The electrospinning apparatus comprises a mandrel, a mask including an aperture, a reservoir loaded with a solution, and an orifice fluidly coupled to the reservoir. The mandrel is located adjacent the target second surface. The orifice is located at a distance from the target first surface. The mask is located intermediate the orifice and the target first surface. The solution is electrospun through the mask aperture onto the target first surface. In one example the target is an endoluminal prosthesis.

Abstract: A cylindrical structure having a lumen to be implanted into a human body. The cylindrical structure has a coating layer formed on at least one part of an inner surface of either or both ends of the cylindrical structure, wherein the coating layer includes a polymer for drug release control and a bioactive material.

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: Various embodiments of methods for coating stents are described herein. Applying a composition including polymer component and solvent to a stent substrate followed by exposing the polymer component to a temperature equal to or greater than a Tg of the polymer component is disclosed. Repeating the applying and exposing one or more times to form a coating with the result that the solvent content of the coating after the final exposing step is at a level suitable for a finished stent is further disclosed.

Abstract: Methods and apparatus are disclosed for loading a therapeutic substance or drug within a lumenal space of a hollow wire having a plurality of side openings along a length thereof that forms a hollow drug-eluting stent with a plurality of side drug delivery openings. Loading a drug within the lumenal space of the hollow stent includes a drug filling step, in which the drug is mixed with a solvent or dispersion medium. The lumenal space may be filled with the drug solution or suspension in a reverse fill process and/or a forward fill process. After the drug filling step, a solvent or dispersion medium extracting step is performed to extract the solvent or dispersion medium from within the lumenal space such that only the drug remains within the hollow stent. A stent cleaning step may be performed to an exterior surface of the hollow stent.

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: The present disclosure relates to self-supporting films for delivery of a therapeutic agent containing at least one hydrophobic polymer and at least one therapeutic agent. Methods of forming the self-supporting films are also disclosed.

Abstract: A method for manufacturing a nerve regeneration-inducing tube with excellent pressure resistance, shape recovery property, anti-kink property, film exfoliation resistance, resistance to invasion of outer tissues, and leakage resistance. The tubular body is formed by weaving together fibers made up of biodegradable polymer. The outer surface of the tubular body is coated multiple times with a collagen solution. The lumen of the tubular body is filled with collagen. Viscosity of the collagen solution that is first applied to the outer surface of the tubular body is between 2 to 800 cps. Viscosity of the collagen solution that is subsequently applied is higher than viscosity of the first applied collagen solution.

Abstract: The invention provides methods and systems that control the application of a material onto micro-rough implant surfaces. Thus, the present invention provides method of applying crystalline nanoparticles onto the surface of an implant to produce an implant with a crystalline nanoparticle layer on its surface, the method comprising: providing an implant substrate body; applying crystalline nanoparticles onto the surface of the implant; and rotating the implant, to produce an implant with a crystalline nanoparticle layer on its surface. This method of nanoparticle application is designed to promote the integration of implants, such as dental and orthopedic screws, into living tissue, and offers the ability to control the thickness and uniformity of the nanoparticle layer, in one or several layers, while simultaneously retaining the microroughness of the implant.

Abstract: The invention relates to a method for modification of a biocompatible component comprising the steps of a) providing a biocompatible component at least partly covered by metallic oxide; and b) treating at least a part of said component, which part is covered by said metallic oxide, with an aqueous composition comprising oxalic acid; whereby a modified metallic oxide is obtained. The invention also relates to a biocompatible component comprising a substrate having a surface comprising a) a microstructure comprising pits separated by plateus and/or ridges; and b) a primary nanostructure being superimposed on said microstructure, said primary nanostructure comprising depressions arranged in a wave-like formation.

Abstract: A stent with at least one severable supporting device and methods of coating using the same are disclosed. The severable supporting device can be an end tube or a tab attached to some portion of the stent by at least one “gate” or attachment. The end tube or tab may be part of the design of the stent when it is originally manufactured, or it may be attached to the stent in a secondary process by a biocompatible glue or solder. The end tube or tab can be used to support a stent during a coating process eliminating the need for a mandrel which would otherwise contact the stent during the coating process.

Abstract: The present invention relates to a gene delivery stent using titanium oxide thin film coating and a method for fabricating the gene delivery stent. The gene delivery stent according to the present invention may be loaded with a drug having anti-inflammatory and anti-thrombotic effects and simultaneously deliver a gene capable of inhibiting proliferation of vascular smooth muscle cells. Accordingly, late thrombosis and metal allergy may be reduced, and vascular restenosis in the stent region may be prevented, thereby making it possible to increase treatment effects of the bare metal stent.

Abstract: This application is directed to a device comprising a covering attached to the device. A process of making a device with a specific covering attached is also disclosed. The application further discloses a method for the treatment of perforations, fistulas, ruptures, dehiscence and aneurisms in luminal vessels and organs of a subject.

Abstract: Coatings for medical devices, methods of making the coatings, and methods of using them are described.

Abstract: The invention is directed to an ion plasma deposition (IPD) method adapted to coat polymer surfaces with highly adherent antimicrobial films. A controlled ion plasma deposition (IPD) process is used to coat a metal or polymer with a selected metal/metal oxide. Exposing the coated surface to ultraviolet light significantly improves the antimicrobial properties of the deposited coatings.

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

Abstract: Medical devices, and in particular implantable medical devices, may be coated to minimize or substantially eliminate a biological organism's reaction to the introduction of the medical device to the organism. The medical devices may be coated with any number of biocompatible materials. Therapeutic drugs, agents or compounds may be mixed with the biocompatible materials and affixed to at least a portion of the medical device. These therapeutic agents or compounds may also further reduce a biological organism's reaction to the introduction of the medical device to the organism. In addition, these therapeutic drugs, agents and/or compounds may be utilized to promote healing, including the prevention of thrombosis. The drugs, agents, and/or compounds may also be utilized to treat specific disorders, including vulnerable plaque. Implantable coated medical devices may be processed through annealing to better control the elution characteristics of the therapeutic agents.

Abstract: Disclosed are devices, methods and systems for treatment of eye disease such as glaucoma. Implants are described herein that enhance aqueous flow through the normal outflow system of the eye with minimal to no complications. The implant can be reversibly deformed to a first shape, such as a generally linear shape conducive to insertion. Upon insertion, the implant can deform to a second shape, such as a generally non-linear shape conducive to retention within the eye. The shape also improves fluid flow from the anterior chamber and prevents or reduces clogging.

Abstract: An implantable prosthesis can comprise a passivating coating within a lumen of a strut and on an interior surface of a metal layer surrounding the lumen. A therapeutic agent is disposed in the lumen. A method for making an implantable prosthesis can comprise applying a passivating coating onto an interior surface of a metal layer surrounding a lumen of a strut, and followed by introducing a therapeutic agent into the lumen.

Abstract: An implantable prosthesis can comprise a strut having a lumen, and radiopaque particles within the lumen. The radiopaque particles placed within the lumen can improve visualization of the prosthesis during an implantation procedure. The radiopaque particles can be bonded to each other to prevent the radiopaque particles from escaping out of the strut.

Abstract: A method for manufacturing a degradation-inhibiting first layer on the surface of an implant body, in particular an intraluminal endoprosthesis, whereby the body has at least one metallic material, which is at least largely biodegradable, comprising the following steps: preparing the body of the implant, and applying the first layer to at least a portion of the body surface, whereby the first layer contains magnesium stearate. An implant obtainable by such a method.

Abstract: The device for placement in a hollow organ, in particular for holding open the hollow organ, comprises a placement body (12) having an inner side and an outer side (14). The device further comprises at least one layer (16) of biostable random-fiber fleece material arranged on said placement body (12) and being at least partially in abutment thereon.