Abstract: A method of making catheters is disclosed in which the wall of the catheter has a porous structure for carrying additional agents, such as therapeutic agents, diagnostic agents and/or device enhancements. The method includes applying a base polymer material and an inert material over the outer surface of a core, and curing or consolidating the base polymer material to form a catheter having a porous polymer layer with the inert material contained within the pores thereof. The inert material can be applied with the base polymer material or in a separate step after the base polymer material has been partially cured or consolidated to form the porous polymer layer. Additional agents can be mixed with the inert material before it is applied to the catheter, or can be applied to the porous polymer layer of the catheter in a separate step after the inert material is removed therefrom.

Abstract: Systems and methods for molding shells for fluid-filled prosthetic implants, including spinning and rotating dip- or spray-mandrels during a devolatilization step to ensure an even covering. The mandrels may be spun during the dipping or spraying step, and/or afterward while a solvent evaporates until a gum state is formed. The techniques are particularly useful for forming hollow shells from silicone dispersions for soft implants, such as breast implants.

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 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: A method for coating a stent can involve a device having a drying zone, a spray zone, and movable member for positioning a stent in the drying zone and another stent in the spray zone. Each stent can be on a support. A force can be applied to the outside surface of a stent to prevent rotation of the stent with respect to the support.

Abstract: The present invention is directed towards the holding of medical devices during manufacture to enable the application of therapeutic and/or protective coatings. More specifically, the present invention provides medical device holders that securely retain stents and other medical devices during the application of a coating while minimizing compressive and tensile forces applied to the stents. The invention avoids disruptions to coating quality due to holder blockage during coating deposition. The invention discloses an improved device containing a mandrel and frame that may improve coating uniformity by eliminating shadowing from the frame of the medical device holder when applying coatings to stents and other medical devices.

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 medical implant and/or device, which includes a biodegradable and cytocompatible magnesium-zinc-strontium alloy is disclosed. The implant and/or device can include a biodegradable and cytocompatible magnesium-zinc-strontium (Mg—Zn—Sr) alloy having a weight percent composition of Zn and Sr as follows: 0.01?Zn?6 wt %, 0.01?Sr?3 wt %. A method for manufacturing an implant in the form of a biodegradable and cytocompatible magnesium-zinc-strontium alloy is disclosed, which includes melting the biodegradable and cytocompatible magnesium-zinc-strontium alloy in an inert environment and molding the biodegradable magnesium-zinc-strontium alloy in a semi-solid state.

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: An implantable biocompatible material includes one or more vacuum deposited layers of biocompatible materials deposited upon a biocompatible base material. At least a top most vacuum deposited layer includes a homogeneous molecular pattern of distribution along the surface thereof and comprises a patterned array of geometric physiologically functional features.

Abstract: A method for producing a bioactive surface on an endoprosthesis, or on the balloon (3) of a balloon catheter (1) is described, wherein the surface (15) of the endoprosthesis, or the surface (4) of the balloon (3) is softened. The surface (15) of the endoprosthesis, or the surface (4) of the balloon (3) is moistened with a solution (6) of an active ingredient (7), and the solvent (8) is separated from the active ingredient (7). In addition, a balloon (3) of a balloon catheter (1) is disclosed, which comprises an uncoated surface (4), wherein an unencapsulated active ingredient (7) is embedded at least partially into the material of the surface (4). Furthermore, a balloon catheter (1) is described, which comprises a balloon (3) according to the invention. In addition, an endoprosthesis, particularly a polymer stent is described, which comprises an uncoated surface (15), wherein an active ingredient (7) is embedded at least partially into the material of the surface (15).

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: Described herein are foam-like materials having substantially the same physical structure of polyurethane foams but with properties that can be tailored for a particular application. Methods of forming these foam-like materials are also described.

Abstract: A substrate is modified by exposing the substrate to a densified fluid. The substrate may be a polymer or a metal alloy, and the densified fluid may be carbon dioxide. Uses of such substrate modification include impregnation of the substrate with one or more drugs, impregnation of microcellular particles, surface modification of the substrate, and formation of microcellular compositions.

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: 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: An implantable or insertable medical device can include a silicone substrate and a plasma-enhanced chemical vapor deposition coating on the silicone substrate. The coating may include a silicon-containing compound. A method of forming the coating is also provided.

Abstract: A process for forming a ceramic layer comprising a compound of a metal on a deposition surface of a workpiece comprises providing a reactive gas, selecting the amounts of a vapor of the metal and ions of the metal relative to each other, generating the metal vapor, and projecting an ion beam of the metal ions. The metal vapor, the metal ions, and the reactive gas form the ceramic layer with a desired structure. The process may include the step of controlling a deposition surface temperature. In one embodiment, the metal vapor comprises zirconium vapor and the ion beam comprises zirconium ions. The relative amounts of the zirconium vapor and the zirconium ions are selected to form a zirconia ceramic layer on the deposition surface. The zirconia may have multiple crystal phases that are formed according to a predetermined ratio.

Abstract: The present invention relates generally to an antibacterial coating which is composed of silver, to medical tools and to implants comprising such a coating and to a method as well to an apparatus for the production of such a coating. The medical tools or the dental or orthopaedic implant comprises a metal or metal alloy having a treated surface wherein the treated surface is at least partially converted to an oxide film by plasma electrolytic oxidation using a colloid-dispersed system and wherein the converted surface is partially covered by islands formed by colloid-dispersed silver-particles of the colloid-dispersed system. An Ag—TiO2 coating shows excellent properties in terms of antibacterial efficacy (even against multi-resistant strains), adhesion and biocompatibility. The life-time of an implant in a human body is increased. The antibacterial coating can be used in the field of traumatology, orthopaedic, osteosynthesis and/or endoprothesis, especially where high infection risk exists.

Abstract: A medical implant for drug delivery comprising an inner layer of polymer material including a drug dispersed therein and an outer layer which may then mediate the release of the drug in a controllable manner. The outer layer may adhere and/or penetrate the underlying layer and offer a protective coating along with improved mechanical strength along with the ability to hydrate and become permeable to water and allow for drug release.

Abstract: The present invention discloses vanadium-based insulin-mimetic agent composite coatings, application of these coatings onto implantable devices, and use of the implantable devices for accelerating osseous healing. The invention also encompasses methods of manufacturing implantable devices coated with vanadium-based insulin-mimetic agent composite coatings and the implantable devices so manufactured. The implantable devices have wide applications, including but not limited to treating bone fracture, bone trauma, arthrodesis, and other bone deficit conditions, as well as bone injuries incurred in military and sports activities.

Abstract: The present invention generally relates to the field of prostheses for surgical applications, to methods of their manufacturing and to methods of treating a patient by implanting them into a patient. More particularly, the present invention relates to prostheses having a multi-layered sheet structure and their use in hernia repair, the repair of anatomical defects of the abdominal wall, diaphragm, and chest wall, correction of defects in the genitourinary system, and repair of traumatically damaged organs such as the spleen, liver or kidney.

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 monolithic material including a first region having a first variability of strength and a second region joined to the first region, the second region having a second variability of strength, wherein the monolithic material has a variability of strength less than the first variability of strength of the first region and less than the second variability of strength of the second region.

Abstract: A based device for use as tissue repair includes a median part between two end parts. The median and end parts have a different tensile stiffness.

Abstract: A method of forming an implant to be implanted into living bone is disclosed. The method comprises the act of roughening at least a portion of the implant surface to produce a microscale roughened surface. The method further comprises the act of immersing the microscale roughened surface into a solution containing hydrogen peroxide and a basic solution to produce a nanoscale roughened surface consisting of nanopitting superimposed on the microscale roughened surface. The nanoscale roughened surface has a property that promotes osseointegration.

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: A prosthetic implant having a thermally treated ceramic coating and a method of producing a coated prosthetic implant. The ceramic coating is deposited onto the prosthetic implant such as by a plasma spray coating process. The prosthetic implant is thermally treated in a low oxygen environment to increase the hardness and wear-resistance of the ceramic coating for improved articulation of the prosthetic implant.

Abstract: A stent crimping and coating apparatus is disclosed. The apparatus includes a plurality of crimping blades positioned in a radial array and collectively forming a central crimping lumen, wherein the plurality of crimping blades radially movable to alter the diameter of the central crimping lumen. Each of the crimping blades includes a first surface configured to at least in part define the central crimping lumen. One or more of the crimping blades includes a fluid channel extending therein and a plurality of openings in fluid communication with the fluid channel. The plurality of openings are located at the first surface of the one or more crimping blades and adapted to discharge a fluid into the central crimping lumen.

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

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 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: 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: 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 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: 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 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 system and method for coating an expandable member of a medical device comprises providing a dispenser in fluid communication with a fluid source with the dispenser having at least one outlet to dispense fluid of the fluid source therefrom. The outlet(s) of the dispenser is positioned proximate a surface of an expandable member, with relative movement between the outlet(s) and the surface of the expandable member established along a coating path, and fluid is dispensed from the dispenser to form a substantially continuous bead of fluid between the at least one outlet and the surface of the expandable member along the coating path, and simultaneously drying the fluid while dispensing the fluid from the dispenser to control flow of fluid on the surface of the expandable member. The fluid source can include a variety of therapeutic agents.

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: 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: 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: Functionalized copolymers of isoolefins and conjugated diolefins, methods of preparing said copolymers, and their use as compatibilizers are disclosed. The diolefin monomer units of the co-polymer are modified at the C—C double bond along the backbone of the copolymer to include an oxygen containing functional group such as epoxide, ester or alcohol. The functionalized copolymers improve the wettabilty of a non-hydrophilic surface towards hydrophilic polymer and allows for the formation of homogenous layers of the hydrophilic polymers. In particular, the spreading of a hydrophilic polymer on a non-hydrophilic substrate is facilitated by applying the co-polymers as an interfacial layer between the two incompatible materials. The resulting coated substrates exhibit resistance to protein adsorption and cell growth after grafting. The co-polymers are especially suited in the coating of biomedical devices where a high degree of uniformity of the coated surface is required.

Abstract: A method of forming a coated medical device is described in which a coating including a therapeutic agent dispersed in a polymer or oligomer matrix is applied to an outer surface of the medical device. The coating is then post-processed to selectively remove a substantial portion of the polymer or oligomer matrix from the coating. The post-processed coating is then sterilized.

Abstract: The present invention relates to a method for preparing a drug-eluting implantable or insertable medical device comprising the steps of (i) providing a implantable or insertable medical device having a surface, (ii) depositing at least two oppositely charged polyelectrolyte layers on at least a portion of said surface to form a polyelectrolyte multilayer on the surface, and (iii) depositing one or more layers of particulate pharmaceutically active ingredient within said polyelectrolyte multilayer or on top of said polyelectrolyte multilayer. The invention also pertains to a drug-eluting implantable or insertable medical device obtained by such a method and the medical uses of such devices.

Abstract: A coating and a method of coating an implantable medical device, such as a stent, is disclosed. The coating compensates for regions of higher stress and resulting strain due to the geometry of the device. Certain embodiments may include a nonuniform coating on the device in which a strain on the nonuniform coating is less than a strain on a uniform coating when the device is placed under an applied stress during use. Other embodiments may include a coating with a greater resistance to strain on higher strain regions of the device.

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: A material derived from sea cucumber collagen fibrils is suitable for use in corneal replacements or as an implantable contact lens. To produce material, the collagen fibrils are centrifuged into orthogonal stacks of lamellae comprised of aligned fibrils. The resulting structure is a transparent film of arbitrary thickness very similar in structure to mammalian corneal tissue.

Abstract: Implantable medical devices, and methods of coating same, including a plurality of components disposed on a substrate, and a low surface energy layer deposited as a liquid over at least a first portion of the components and the substrate, the low surface energy layer becoming solidified after deposition and conforming to at least the first portion of the components. The devices further include a biocompatible hermetic coating conforming to and sealingly covering at least a portion of the low surface energy layer.