Abstract: A method of coating an implantable medical device, such as a stent, is disclosed. The method includes applying a formulation on a first polymer layer containing a therapeutic substance to form a second layer. The formulation can contain a highly hydrophobic polymer or a solvent which is a poor solvent for the drug or the polymer of the first layer. The formulation can have a low surface tension value or a high Weber number value.

Abstract: Described herein are implantable medical devices that can be coated with polymers and/or bioactive agents with the aid of supercritical fluids and methods for coating the devices. The medical devices described herein can have at least a portion of their surface made of or formed from a porous material. The supercritical fluids are used as a carrier for the bioactive agents described. Once the bioactive agents are carried to the medical device surface, they are sequestered there, preferably in the pores. The supercritical fluid is sprayed onto the medical devices achieving precipitation of the fluid. If appropriate conditions are used in the area of precipitation, bioactive agents can penetrate into the pores of the medical device before coming out of solution and expanding.

Abstract: A medical device having a contact surface exposed repeatedly to bodily tissue is disclosed. The contact surface is coated with a silicone polymer and one or more non-silicone hydrophobic polymers. The preferred medical device is a surgical needle, and the preferred coating is a polydimethylsiloxane and polypropylene wax hydrocarbon mixture. The incorporation of the non-silicone hydrophobic polymer increases the durability of the coating on the device without sacrificing lubricity.

Abstract: A coating can be applied to an endolumenal wall of a medical device by positioning an optical fiber within the lumen, providing a photo-activated chemical to contact the endolumenal wall, supplying the optical fiber with radiation capable of activating the chemical within the lumen, and withdrawing the optical fiber from the lumen at a controlled rate while the radiation is being emitted from the optical fiber to activate the chemical in close proximity to the endolumenal wall.

Abstract: Medical devices, such as stents, having a surface, a coating layer comprising a polymer disposed on at least a portion of the surface, and a composition comprising a biologically active material injected into or under the coating layer at one or more locations in the coating layer to form at least one pocket containing a biologically active material are disclosed. The composition may be injected using a nanometer- or micrometer-sized needle. Methods for making such medical devices are also disclosed. Using this method, a precise amount of the biologically active material may be disposed accurately and efficiently on the medical device at predefined locations.

Abstract: A method of forming a surface layer that includes a hydroxyl polymer on a substrate coating on a medical device is provided.

Abstract: A wire guide includes a mandrel that has a proximal portion and a distal portion. A first coating with a low coefficient of friction is disposed on the proximal portion of the mandrel. A second coating is disposed on the distal portion of the mandrel, where the second coating provides a sub-structure. A third coating is disposed on the second coating, where the third coating comprises a surface that allows for easy maneuverability of the wire guide. The first coating on the proximal portion provides enough lubricity to keep the wire guide from becoming bound or stuck in a catheter or medical device while still allowing a user to have a good grip of the wire guide. The second coating on the distal portion provides lubricity for the wire guide, which allows the user to easily maneuver the wire guide through a vascular anatomy.

Abstract: Methods are provided for preparation of a coating on one or more microprojections of a microprojection array using wetting agents either as a pretreatment of the microprojection surfaces or incorporated in the coating formulation along with the active agent.

Abstract: System and method for coating a medical appliance are provided. In accord with one embodiment, a system for applying a coating to a medical appliance having accessible patterned surfaces is provided. The system may include: a processor, an appliance support, and a solenoid type fluid dispensing head having an electromagnetically controlled valve. In the system, the appliance support may be adapted to hold the medical appliance and to provide direct access for a coating to contact the exposed external patterned surfaces of the medical appliance. The solenoid type fluid dispensing head in this system may move with respect to the medical appliance and may be in communication with a source of coating and with the processor. The processor in this system may contain commands that instruct the solenoid type fluid dispensing head to force coating onto the accessible patterned surfaces of the medical appliance in a pattern that correlates with the accessible patterned surfaces of the medical appliance.

Abstract: Methods for fabricating coatings for implantable medical devices are disclosed. The coatings include hydrophilic and hydrophobic components. The methods provide for treatment of the coatings to cause enrichment a region close to, at or on the outer surface of the coating with the hydrophilic component.

Abstract: Compositions, methods, devices and kits utilizing water-based hydrophilic coating formulations on medical implements. The composition for applying a coating comprises a sulfonated polyester, water, and a surface active agent. Methods for coating a medical implement comprise providing an aqueous dispersion comprising sulfonated polyester and surface active agent, contacting the medical implement with the aqueous dispersion, and drying the medical implement. Methods for acquiring a sample of bodily fluid from a patient comprise coating a needle with a sulfonated polyester, penetrating the needle into the patient, and drawing bodily fluid through the needle.

Abstract: An ultrasonic surgical blade includes a body having a proximal end, a distal end, and an outer surface. The distal end is movable relative to a longitudinal axis in accordance with ultrasonic vibrations applied to the proximal end. At least a portion of the outer surface of the body comprises a lubricious coating adhered thereto. The lubricious coating has a coefficient of friction that is less than the coefficient of friction of the outer surface of the body.

Abstract: A device (12) and method are provided for percutaneous transdermal delivery of a potent pharmacologically active agent. The agent is dissolved in water to form an aqueous coating solution having an appropriate viscosity for coating extremely tiny skin piercing elements (10). The coating solution is applied to the skin piercing elements (10) using known coating techniques and then dried. The device (12) is applied to the skin of a living animal (e.g., a human), causing the microprotrusions (10) to pierce the stratum corneum and deliver a therapeutically effect dose of the agent to the animal.

Abstract: This invention relates to a method of making an intraocular lens insertion device comprising a lubricious insertion tip assembly and to the device itself.

Abstract: The present invention concerns bio-compatible medical devices and process for preparation thereof. The process includes electrostatically forming a first layer on a structure. The first layer can include a combination of at least one active substance and at least one polymer and/or binder. A second layer is formed on the structure to cover the first layer. The second layer can be a solvent or a combination of solvents. The evaporation of the second layer causes the first layer to reflow and bind to the structure.

Abstract: The present invention provides a microneedle device having a coating, which is effective even with a low molecular weight active compound and can sustain the effect of the drug for a long period of time, and a transdermal drug administration apparatus with microneedles. The microneedle device (5) has, on a microneedle substrate (8), a plurality of microneedles (6) that can pierce the skin, wherein the surface of the microneedles (6) and/or the microneedle substrate (8) is partly or entirely coated in fixed state with a coating carrier containing polyvinyl alcohol. The polyvinyl alcohol preferably has a hydrolysis degree of 94.5 mol % or more. Furthermore, the coating carrier can contain a drug.

Abstract: The invention provides an apparatus for coating a device comprising a coating chamber and a device rotator having at least one device mount wherein the apparatus allows insertion and retraction of the device on the device mount into and out of the coating chamber. In another aspect, the invention provides a method of applying a substantially uniform coating on a device comprising the steps of providing an apparatus for coating a device, mounting the device onto the device mount, purging the coating chamber to reduce humidity in the coating chamber, maintaining a reduced humidity content in the coating chamber, inserting the device into the coating chamber, disposing a coating material on the device and rotating the device mounts about the device axis.

Abstract: A coating for a medical device, particularly for a drug eluting stent, is described. The coating includes a purified polymer such as a polyacrylate.

Abstract: Methods of fabricating a cannula are disclosed that include, among others, the steps of providing an elongated cannula body, applying a metallurgical-type coating to the cannula body, and forming a bevel on a distal end portion of the cannula body. In one embodiments the step of applying a metallurgical-type coating to the cannula body is performed prior to the step of forming the bevel on the distal end portion of the cannula body. In another embodiment, the step of applying a metallurgical-type coating to the cannula body is performed subsequent to the step of forming the bevel on the distal end portion of the cannula body. Both methods provide extremely sharp cutting edges that are harder and more durable than the underlying substrate.

Abstract: A method for immobilizing dyes and antimicrobial agents on a porous surface is disclosed and described. The surface may be that of a medical device, such as a catheter, a connector, a drug vial spike, a bag spike, a prosthetic device, an endoscope, and surfaces of an infusion pump. The surfaces may also be one or more of those associated with a dialysis treatment, such as peritoneal dialysis or hemodialysis, where it is important that working surface for the dialysis fluid be sterile. These surfaces include connectors for peritoneal dialysis sets or for hemodialysis sets, bag spikes, dialysis catheters, and so forth. A method for determining whether a surface has been sterilized, and a dye useful in so indicating, is also disclosed.

Abstract: A medical device comprising a substrate having a plasma polymerized functionality bonded to at least a portion of the substrate. A superoxide dismutase mimic agent having a complimentary functional group to the plasma polymerized functionality is bonded to the portion of the substrate by bonding to the plasma polymerized functionality. The functionalities can be carboxylate, amine, or sulfate groups and/or polyethylene glycol and can optionally include crosslinking groups.

Abstract: A method of manufacturing microneedles is provided, the method includes (i) depositing a substance onto a first surface and (ii) forming a solid needle-like shape from the substance. The substance may be deposited in non-solid form and subsequently solidified. A method provides an array of such microneedles.

Abstract: An apparatus comprises a dispenser, a coherent energy source and an beam steering system. The dispenser defines a path of a droplet. The beam steering system is coupled to the coherent energy source and is configured to define a beam path of the coherent energy source. The beam path of the coherent energy source is disposable across the dispenser path at an interaction location. The beam steering system and coherent energy source are collectively configured such that at least one of a direction, a velocity and an acceleration of the droplet is modified within the interaction location.

Abstract: A method for making an intravascular stent by applying to the body of a stent a solution which includes a solvent, a polymer dissolved in the solvent and a therapeutic substance dispersed in the solvent and then evaporating the solvent. The inclusion of a polymer in intimate contact with a drug on the stent allows the drug to be retained on the stent during expansion of the stent and also controls the administration of drug following implantation. The adhesion of the coating and the rate at which the drug is delivered can be controlled by the selection of an appropriate bioabsorbable or biostable polymer and the ratio of drug to polymer in the solution. By this method, drugs such as dexamethasone can be applied to a stent, retained on a stent during expansion of the stent and elute at a controlled rate.

Abstract: A multi-step method of manufacturing a medical device containing therapeutic agents that results in a lower maximum error in the amount of therapeutic agents actually disposed thereon and that allows for differential drug release kinetics along the length of the medical device.

Abstract: A support device for a stent and a method of coating a stent using the device are provided.

Abstract: A method for furnishing a therapeutic-agent-containing medical device is provided. The method comprises: (a) providing a reactive layer comprising a cross-linking agent on a medical device surface; and (b) subsequently applying a polymer-containing layer, which comprises a polymer and a therapeutic agent, over the reactive layer. The cross-linking agent interacts with the polymer to form a cross-linked polymeric region that comprises the therapeutic agent. Moreover, in certain embodiments, the polymer-containing layer does not comprise the cross-linking agent at the time the polymer-containing layer is applied over the reactive layer. Examples of medical devices include implantable or insertable medical devices, for example, catheters, balloon, cerebral aneurysm filler coils, arterio-venous shunts and stents.

Abstract: A method of impregnating an implantable device, such as a vasclar graft or a covering adapted to be disposed over a prosthesis, is provided. The substances may be impregnated within the implantable device as a passive coating or as a delivery matrix for a matrix for a therapeutic substance. Also provided is an implantable device having such substances impregnated therein.

Abstract: An elongate medical device including a coating extending over a portion of the elongate medical device having a plurality of apertures formed thereon and a method of applying a coating to such an elongate medical device are disclosed. Prior to applying a coating to the elongate medical device, a removable liquid is dispensed in the plurality of apertures. Subsequently, the removable liquid is removed from the plurality of apertures, leaving the plurality of apertures free of, unobstructed by, or otherwise not filled with the coating.

Abstract: Methods and apparatuses for coating surface of medical devices using coating heads are disclosed. In one embodiment, the invention includes a coating method using a coating head, wherein the coating head comprises at least one outlet orifice from which flows a coating material, to deposit at least one layer of coating material dispelled through the outlet orifice onto the surface of the medical device. In another embodiment, a slide coating head is used to deposit multiple layers of superposed coating materials. These methods are used to apply one or more coating materials, simultaneously or in sequence. In certain embodiments of the invention, the coating materials include therapeutic agents, polymers, sugars, waxes, or fats.

Abstract: The present invention relates to a coating assembly and methods that employ the coating assembly to control the thickness of therapeutic or other coatings delivered to a medical device during a coating process. In one embodiment the coating assembly may include a coating plate having a coating transfer surface and a shoulder having a first height, a mandrel moveable over the coating transfer surface, and a coating dispenser positioned in fluid communication with the coating transfer surface. The invention also includes a method of coating a medical device. This method may include placing a medical device on a mandrel, dispensing coating onto a coating transfer surface of a coating plate, moving the mandrel and the medical device over the coating transfer surface of the coating plate so that coating resident on the coating transfer surface transfers to an exposed surface of the medical device, and removing the medical device from the mandrel.

Abstract: A method of forming a coating for an implantable medical device, such as a stent, is provided which includes applying a composition to the device in an environment having a selected pressure.

Abstract: A medical device comprising a substrate having a plasma polymerized functionality bonded to at least a portion of the substrate. A superoxide dismutase mimic agent having a complimentary functional group to the plasma polymerized functionality is bonded to the portion of the substrate by bonding to the plasma polymerized functionality.

Abstract: An apparatus and method for improved control of low viscosity fluid flow during electrohydrodynamic spray deposition of the fluid to coat small targets, such as medical devices like stents. The apparatus includes a target holder which applies a first electrical potential to a target, a coating fluid transporter such as a wick, a siphon tube or a siphon tube with a wick therein along which the coating fluid flows from a reservoir to a dispensing end of the transporter, and an electrode which applied a second electrical potential to the coating fluid sufficient to cause the coating fluid to be attracted from the dispensing end of the transporter toward the target. This provides a target coating apparatus with highly self-regulating coating fluid flow characteristics despite the low viscosity of the coating fluid, while producing highly consistent and uniform target coatings.

Abstract: This invention is a method of forming a nitride layer on at least one metal or metal alloy biomedical device, comprising: providing a vacuum chamber with at least one biomedical device positioned thereon on a worktable within the vacuum chamber; reducing the pressure in the vacuum chamber; introducing nitrogen into the vacuum chamber so that the pressure in the vacuum chamber is about 0.01 to about 10 milli-Torr; generating electrons within the vacuum chamber to form positively charged nitrogen ions; providing a negative bias to the worktable so that the positively charged nitrogen ions contact the biomedical devices under conditions such that a nitride layer forms on the at least one prosthetic device.

Abstract: A stent mounting device and a method of coating a stent using the device are provided.

Abstract: A method for coating an implantable medical device that has the steps of applying a polymer composition onto the device, the polymer composition including a solution of a polymer in a solvent, and drying the polymer composition for a period of time at a drying temperature higher than the room temperature in an environment having relative humidity between about 20% and about 100%.

Abstract: A molecular plasma discharge deposition method for depositing colloidal suspensions of biomaterials such as amino acids or other carbon based substances onto metal or nonmetal surfaces without loss of biological activity and/or structure is described. The method is based on generating a charged corona plasma which is then introduced into a vacuum chamber to deposit the biomaterial onto a biased substrate. The deposited biomaterials can be selected for a variety of medical uses, including coated implants for in situ release of pharmaceuticals.

Abstract: The present invention relates to antimicrobial compositions, methods for the production of these compositions, and use of these compositions with medical devices, such as catheters, and implants. The compositions of the present invention advantageously provide varying release kinetics for the active ions in the compositions due to the different water solubilities of the ions, allowing antimicrobial release profiles to be tailored for a given application and providing for sustained antimicrobial activity over time. More particularly, the invention relates to polymer compositions containing colloids comprised of salts of one or more oligodynamic metal, such as silver. The process of the invention includes mixing a solution of one or more oligodynamic metal salts with a polymer solution or dispersion and precipitating a colloid of the salts by addition of other salts to the solution which react with some or all of the first metal salts.

Abstract: Bactericidal compositions are disclosed that comprise a polymeric compound immobilized on a material. Medical devices are also disclosed which comprise such a bactericidal composition. Methods are disclosed for covalently derivatizing the surfaces of common materials with an antibacterial polycation, e.g., poly(vinyl-N-pyridinium bromide); the first step of the methods involves coating the surface with a nanolayer of silica. Various commercial synthetic polymers derivatized in this manner are bactericidal, i.e., they kill on contact up to 99% of deposited Gram-positive and Gram-negative bacteria, whether deposited through air or water.

Abstract: A method for coating a medical appliance includes suspending the medical appliance with a fluidizing gas flow and directing a coating onto an ultrasonic nozzle. The ultrasonic nozzle is directed towards the medical appliance. The method also includes vibrating the ultrasonic nozzle at a rate sufficient to atomize the coating. A device for coating a medical appliance includes a fluidizing gas source adapted to suspend the medical appliance in a suspension area and an ultrasonic nozzle directed at the suspension area and adapted to vibrate. The device also includes a coating source adapted to direct coating onto the ultrasonic nozzle. A medical appliance is provided which has a coating applied by the method.

Abstract: The present invention is a method and device, which is suitable for use in an operating theater just prior to implantation, for selectively applying a medical coating to an implantable medical device, for example a stent. Disclosed is a device for use with a stent deployed on a catheter balloon. The device is configured to apply a medical coating of a desired thickness to the surface of a stent only. This is done by use of a drop-on-demand inkjet printing system in association with an optical scanning device. The device is further configured so as to, if necessary, apply a plurality of layered coats, each layered coat being of a different coating material, and if appropriate, different thickness. The section of the housing in which the stent is held during the coating procedure is detachable from the housing base. The detachable housing section may be easily cleaned and re-sterilized or simply disposed or simply disposed of.

Abstract: The invention discloses materials that adsorb readily to the surfaces of body tissues in situ and provide a steric barrier between such tissues, so that tissue adhesions, which typically form following surgical procedures, are minimized. These materials contain a polymer of hydrophilic molecules such as polyethylene glycol (PEG) bound to a polymer that spontaneously adsorbs to biological tissue such as phenylboronic acid (PBA). The PEG-PBA co-polymer can be formed in a variety of geometries. The materials can also be used to coat prosthetics and other implants.

Abstract: The invention is drawn to silane copolymers prepared from the reaction of one or more polyisocyanates with one or more lubricious polymers having at least two functional groups, which may be the same or different, that are reactive with an isocyanate functional group and with one or more organo-functional silanes having at least two functional groups, which may be the same or different, that are reactive with an isocyanate functional group and at least one functional group reactive with a silicone rubber substrate. The silane copolymers of the invention can be used as coatings that are elastic when dry, lubricious when wet, and resist wet abrasion. These copolymers are useful as coatings for polysiloxane (rubber) and other difficult to coat substrates, especially for medical devices, such as catheters. These silane copolymers can contain active agents such as antimicrobials, pharmaceuticals, herbicides, insecticides, algaecides, antifoulants, and antifogging agents.

Abstract: Compositions, methods, devices and kits utilizing water-based hydrophilic coating formulations on medical implements. The composition for applying a coating comprises a sulfonated polyester, water, and a surface active agent. Methods for coating a medical implement comprise providing an aqueous dispersion comprising sulfonated polyester and surface active agent, contacting the medical implement with the aqueous dispersion, and drying the medical implement. Methods for acquiring a sample of bodily fluid from a patient comprise coating a needle with a sulfonated polyester, penetrating the needle into the patient, and drawing bodily fluid through the needle.

Abstract: An improved method for high-volume production of coated stents with highly uniform stent coatings using a roll coating technique is provided. In a first embodiment, uncoated stents are placed onto rotating stent holders with automated stent handling equipment. The holders are mounted on an endless conveyer belt which advances the stents toward a stent coater. As the stents advance through the coater, the holders rotate, thereby rolling the stents about their longitudinal axes as coating material is sprayed toward them, ensuring the stents are uniformly coated on their exterior and interior surfaces. After the conveyer turns to carry the coated stents back toward the loading area, the rotating stents pass again through the coating spray, downstream of the initial coating location, thereby increasing the efficient utilization of the coating material. The conveyer then advances the coated stents to an unloading area for removal before the holders return to the stent loading area to receive new stents.

Abstract: A method for improving the wettability of a medical device involves: (a) providing a medical device formed from a monomer mixture comprising a hydrophilic device-forming monomer including a copolymerizable group and an electron donating moiety, and a second device-forming monomer including a copolymerizable group and a reactive functional group; and (b) contacting a surface of the medical device with a wetting agent including a proton donating moiety reactive with the functional group provided by the second lens-forming monomer and that complexes with the electron donating moiety provided by the hydrophilic lens-forming monomer.

Abstract: A siliconized surgical needle is provided which requires significantly less force to effect tissue penetration than a standard siliconized needle.

Abstract: Methods for fabricating coatings for implantable medical devices are disclosed. The coatings include blends of hydrophilic and hydrophobic polymers. The methods provide for treatment of the coatings to cause enrichment a region close to the outer surface of the coating with the hydrophilic polymers.

Abstract: A method for furnishing a therapeutic-agent-containing medical device is provided. The method comprises: (a) providing a reactive layer comprising a cross-linking agent on a medical device surface; and (b) subsequently applying a polymer-containing layer, which comprises a polymer and a therapeutic agent, over the reactive layer. The cross-linking agent interacts with the polymer to form a cross-linked polymeric region that comprises the therapeutic agent. Examples of medical devices include implantable or insertable medical devices, for example, catheters, balloon, cerebral aneurysm filler coils, arterio-venous shunts and stents.