Abstract: Provided are multi-layer antithrombic coatings comprising an outermost layer of an antithrombic agent, such as a heparin conjugate, bound to a penultimate polymeric layer comprising cationic polymer species that is bound alternating polymeric layers comprising anionic polymer species and cationic polymer species, and uses thereof.

Abstract: A one step method for drug coating an interventional device is disclosed by mixing a drug with a phosphorylcholine-linked methacrylate polymer in a liquid and applying the mixture to an interventional device, such as a stent, in a single step.

Abstract: This invention relates to an method of manufacture of an implantable medical device comprising an oxygen-sensitive rapamycin derivative that is protected by addition of an antioxidant during the manufacturing process where the amount of antioxidant added at the outset of the processing is such that when the device is fully fabricated, sterilized and packaged the amount of antioxidant has reduced to a minimal, preferably non-detect, amount.

Abstract: An implantable medical device includes a lead body having a distal end and a proximal end, a lumen and at least one lead wire extending through the lumen. The lead wire has an outer surface and a polymeric coating on at least a portion of the outer surface of the lead wire. The coating includes a first structure having a first end proximate the outer surface of the lead wire and a second end opposite the first end. The second end is movable relative to the first end and relative to the lead wire.

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

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: Biocompatible coatings and spin finishes that can be applied to polyhydroxyalkanoate (PHA) polymers, and medical devices made from PHA polymers, have been developed. The coatings impart good lubricity to PHA polymers, particularly to fibers and braids made from these materials, making the coatings ideal for use on medical devices such as PHA braided sutures. The spin finishes can be applied to PHA fibers to facilitate their manufacture, and also for their conversion to other products, including medical textiles. The spin finishes serve to protect multifilament fiber bundles, and keep them intact following extrusion, and also to impart lubricity to the fiber bundles and monofilament fibers so that they are not damaged in subsequent processing steps particularly in textile processing. The coating reduces tissue drag of, for example, braided sutures.

Abstract: An orthopedic implant has a prosthetic joint component made, for example, of polyethylene and another component made of a titanium or titanium alloy substrate. The substrate has a first bearing surface coated with a coating made of a cobalt-chromium molybdenum alloy. The bearing surface slidably receives a second bearing surface of the prosthetic joint component. The cobalt-chromium molybdenum alloy coating forming the first bearing surface is made up of hexagonal close packed (HCP) grains having a columnar structure with a length of about 1 ?m and a width of about 0.1 ?m with the length of each HCP grains being oriented generally perpendicular to the titanium substrate bearing surface.

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: A textured breast implant is provided which generally includes a fluid fillable elastomeric shell having a texture defined by struts, for example, hollow struts, defining interconnected open cells. Methods of making the texture include applying a silicone dispersion to a base material and removing the base material from the coating to form a silicone-based structure comprising struts defining interconnected open cells, said struts including internal surfaces defining cavities within the struts. The method may further include the step of contacting the silicone based structure having cavities with a silicone dispersion to cause the silicone to enter and fill the cavities.

Abstract: Polymeric composite stents reinforced with fibers for implantation into a bodily lumen are disclosed.

Abstract: Methods and devices for stabilizing ligaments of the canine stifle joint are described. In one embodiment, a device for promoting stability of the stifle joint in a canine subject is provided. The device includes a buttress comprising an intra-articular portion and an extra-articular portion, where the intra-articular portion of the buttress is fenestrated. The device also includes a keel coupled to the extra-articular portion of the buttress, and one or more fasteners configured to attach the device to the stifle joint.

Abstract: An implant and a process for preparing such an implant are disclosed. The implant includes a mesh including a biodegradable polymeric coating having glass transition temperature of about 26° C. to about 36° C. The polymeric coating includes a first polymeric component including a lactone and a second polymeric component including a polyether. The first polymeric component is present in an amount from about 90% to about 99% of the polymeric coating and the second polymeric component is present in an amount from about 1% to about 10% of the polymeric coating.

Abstract: A medical device having an antimicrobial coating. The device has a first coating layer having an antimicrobial agent over at least part of the outer surfaces of the device. The first coating has an outer surface. There is a second discontinuous polymeric coating containing an antimicrobial agent, which is on top of and covering part of the outer surface of the first coating. The second discontinuous coating has a microstructure.

Abstract: An inkjet printing method, system, and computer-usable tangible storage device to print cells and biomaterials for three-dimensional cellular scaffolds and engineered skin grafts are disclosed. The process simultaneously deposits living cells, nutrients, growth factors, therapeutic drugs along with biomaterial scaffolds at the right time and location. This technology can also be used for the microvasculature fabrication using appropriate human microvascular endothelial cells and fibrin to form the microvasculature. When printing human microvascular endothelial cells in conjunction with the fibrin, the cells aligned themselves inside the channels and proliferated to form confluent linings. The 3D tubular structure was also found in the printed patterns. Simultaneously printing biological materials to form a three-dimensional cellular scaffold promotes human microvascular endothelial cell proliferation and microvasculature formation.

Abstract: A preparation method for medical porous tantalum implant material is provided, which includes mixing polyethylene glycol aqueous solution and tantalum powder to form tantalum slurry, casting the tantalum slurry into an organic foam body through vibrant pressurization, and going through steps of drying, degreasing, vacuum sintering and thermal treatment to obtain the porous tantalum. The solution is a 2-8 wt % polyethylene glycol aqueous solution, the frequency of vibration is 20-80 times/min, the thermal treatment is performed under 10?4-10?3 Pa of vacuity and the temperature is increased to 800-900° C. at a rate of 10-20° C./min and keeping the temperature for 240-480 minutes, then decreased to 400° C. at a rate of 2-5° C./min and keeping the temperature for 120-300 minutes, and cooled down to the room temperature naturally in the furnace.

Abstract: A micro-alloyed porous metal is disclosed having an optimized chemical composition to achieve targeted mechanical properties for use as an orthopaedic implant and a cell/soft tissue receptor. The porous metal may achieve a targeted compressive strength and a targeted ductility, for example. These targeted mechanical properties may allow the porous metal to be densified to a low relative density.

Abstract: A method of modifying a medical device such as a stent with nano-constructs is disclosed. The method comprises applying a first fluid to the stent; immersing the stent being wet from the first fluid into a second fluid having a suspension of nano-constructs; and removing the stent from the second fluid and allowing the first and second fluid to be removed such that the nano-constructs are carried by the stent for in vivo application of the constructs to a target location of a mammalian subject. The nano-constructs can be attached to the surface of the stent, can be attached to a surface of the coating of the stent, can be embedded into the stent, or can be embedded into the coating.

Abstract: The gradient coated stent 150 of the present invention provides a coated stent having a continuous coating 130 disposed on the stent elements. The continuous coating 130 includes a first coating component and a second coating component. The concentration of the first coating component varies continuously over at least part of the thickness of the continuous coating 130. The concentration of the second coating component can also vary over at least part of the thickness of the continuous coating 130. In one embodiment, the concentration of the first coating component decreases in the direction from the stent element towards the outer edge of the continuous coating 130 and the concentration of the second coating component increases in the direction from the stent element towards the outer edge of the continuous coating 130.

Abstract: According to some embodiments, the present invention provides a modified silicone surface for interference to pathogen colonization comprising: an activated silicone layer; a plurality of cross-linking dendrimers adsorbed onto to the activated silicone layer; a plurality of ligand derivatives, each bound to at least one of the plurality of cross-linking dendrimers; and a benign biofilm adhered to the plurality of ligand derivatives. According to some embodiments, the present invention provides a method for making a modified silicone surface for interference to pathogen colonization comprising activating a silicone surface; adsorbing a plurality of cross-linking dendrimers to the silicone surface; binding a plurality of ligand derivatives to the plurality of cross-linking dendrimers; and adhering a benign biofilm to the plurality of ligand derivatives.

Abstract: A composite bone implant. In some embodiments, one or more features are provided, such as markers for passageways, axial engagement of bone screws, sliding support of bone screws and/or a cannulated channel for a guide wire.

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 heat nozzle configured for applying a uniform drying gas.

Abstract: This disclosure describes the application of a supplemental corona source to provide surface charge on submicrometer particles to enhance collection efficiency and micro-structural density during electrostatic collection.

Abstract: Provided are a polymer composition on a substrate and a surface modification method which is non-selective to substrate materials. Chemical vapor deposition polymerization is used to deposit a maleimide-functionalized poly-p-xylylene coating on a substrate. The substrate is readily available to perform a thiol-maleimide coupling reaction under mild conditions so as to modify the surface thereof. Furthermore, through a tailored thiol-terminal molecule, a designer surface can be created via thiol-maleimide coupling on a substrate, and the resulting surface can exhibit various desired biological functions for biotechnological applications. Therefore, this modification technique can be applied to biological fields extensively.

Abstract: Provided herein is an apparatus for printing cells which includes an electrospinning device and an inkjet printing device operatively associated therewith. Methods of making a biodegradable scaffold having cells seeded therein are also provided. Methods of forming microparticles containing one or more cells encapsulated by a substrate are also provided, as are methods of forming an array of said microparticles.

Abstract: Sterile micron-sized gold particles contained in capped vials, a kit of part including the vial and a liquid capable of suspending the particles, as well as their preparation, medical devices or medicaments prepared by their preparation as well as uses thereof in treating inflammation. Also, gold coated implants preferably for use in combination with the medical devices.

Abstract: The present invention relates to polymers and, specifically, to surface modification of polymers. In one exemplary embodiment, the present invention increases the bond strength of UHMWPE components to PMMA bone cement by creating a chemical bond between the UHMWPE components and the PMMA bone cement. Specifically, in one exemplary embodiment, a surface of the UHMWPE component that is to be bonded to PMMA bone cement is treated with an oxidizing agent, such as an aqueous solution of hydrogen peroxide. In one exemplary embodiment, the UHMWPE component is treated with hydrogen peroxide by swabbing the surface of the UHMWPE component with the hydrogen peroxide solution. The surface of the UHMWPE component may then be dried and PMMA bone cement applied to the surface of the UHMWPE component.

Abstract: An implant, in particular an intraluminal endoprosthesis, is provided having an implant body containing biodegradable metallic material, preferably iron. To accelerate the degradation, at least a portion of the surface of the implant body has a first coating formed from a composition containing at least one element selected from the group including strontium and calcium. An inexpensive method for manufacturing such an implant is also described.

Abstract: The present invention is directed to methods for producing a coated substrate, including dissolving at least one biomolecule to form a solution; nebulizing the solution to form a liquid aerosol; combining the liquid aerosol and a plasma to form a coating; and depositing, in the absence of reactive monomers, the coating onto a substrate surface. In an aspect, the substrate can be an implantable medical device.

Abstract: The invention generally relates to systems and methods for making gelatin shunts. In certain embodiments, the invention provides methods that may involve moving a wire through a bath including a bottom layer of liquid gelatin and a top layer of water, thereby coating the wire with gelatin, moving the gelatin coated wire through an aperture, and drying the gelatin on the wire in a humidity controlled space, thereby manufacturing a gelatin shunt. In other embodiments, the invention provides systems that may include a motor, a wire operable coupled to the motor for movement of the wire, a temperature controllable bath, an aperture plate situated in a top portion of the bath, and an ultrasonic fogger, in which the system is configured such that the wire moves through the bath, through the aperture plate, and into the ultrasonic fogger.

Abstract: The present invention provides a plasticized dehydrated or freeze-dried bone and/or soft tissue product that does not require special conditions of storage, for example refrigeration or freezing, exhibits materials properties that approximate those properties present in normal hydrated tissue, is not brittle, does not necessitate rehydration prior to clinical implantation and is not a potential source for disease transmission. The invention replaces water in the molecular structure of the bone or soft tissue matrix with one or more plasticizers allowing for dehydration of the tissue, yet not resulting in an increase in brittleness of the plasticized product, and resulting in compressive and/or tensile properties similar to those of normal hydrated bone. Replacement of the chemical plasticizers by water prior to implantation is not required and thus, the dehydrated bone or soft tissue plasticized product can be placed directly into an implant site without significant preparation in the operating room.

Abstract: Devices and methods are provided for making a variable textured breast implant when used in conjunction with a breast implant mandrel having a molding surface and a stem depending therefrom.

Abstract: A solventless method for forming a coating on a medical electrical lead is described. The method includes combining particles of a therapeutic agent with a polymeric material in a flowable form in the absence of a solvent to form a uniform suspension. A predetermined amount of the suspension is dispensed onto a portion of the lead and is then cured to form the therapeutic agent eluting layer. Additional layers such as a primer layer, fluoro-opaque layer and/or a topcoat layer can be formed using the solventless method. Employing a solventless method may avoid contraction of the layer being formed due to solvent evaporation during the curing process, and may facilitate greater control over the thickness of the therapeutic agent eluting coating.

Abstract: Methods for creating a foam-like texture on an implantable material are provided. More particularly, methods for creating foam-like texture on implantable silicone materials are provided.

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

Abstract: Methods of coating an implantable device, such as a stent, are provided.

Abstract: An apparatus is disclosed including a workspace for receiving a stent and a delivery device for the stent; a source for exposing the stent in the workspace to a plasticizing agent, vapor, or moisture, wherein the stent can be reduced in diameter in the workspace while under exposure of the plasticizing agent, vapor or moisture; and a device for reducing the diameter of the stent in the workspace to position the stent on or within the deliver device.

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: An implantable or insertable medical device is provided which contains the following: (a) a substrate, (b) a therapeutic agent-containable region disposed over the substrate, (c) a nanoporous polymeric layer disposed over the therapeutic agent-containable region and (d) a macroporous non-polymeric layer disposed over the nanoporous polymeric layer. The nanoporous polymeric layer largely regulates transport of species between the therapeutic agent-containable region and the exterior of the device. The macroporous non-polymeric layer has a larger pore size than the nanoporous polymeric layer and largely serves to isolate the polymeric material from surrounding tissue during in-situ delivery of the therapeutic agents.

Abstract: The invention relates to a ceramic implant, especially a dental implant, comprising a structured or porous surface for at least partially inserting into a bone. An especially advantageous surface is obtained when it is at least partially modified by a salt melt. These excellent osteointegration properties can be obtained by a method whereby the surface is modified in a salt melt at least in the regions exposed to the bones and/or soft tissue, optionally following a previous modification of the surface whereby material has been removed.

Abstract: Aspects of the disclosure relate to synthetic tissue or organ scaffolds and methods and compositions for promoting or maintaining their structural integrity. Aspects of the disclosure are useful to prevent scaffold damage (e.g., delamination) during or after implantation into a host. Aspects of the disclosure are useful to stabilize tissue or organ scaffolds that include electrospun fibers.

Abstract: A method of manufacturing an endoluminal implantable surface, stent, or graft includes the steps of providing an endoluminal implantable surface, stent, or graft having an inner wall surface, an outer wall surface, and a wall thickness and forming a pattern design into the endoluminal implantable surface, stent, or graft. At least one groove is created in the inner surface of the intravascular stent by applying a laser machining method to the inner surface.

Abstract: Provided according to embodiments of the invention are NO-releasing sol-gel coating formed from a sol precursor solution comprising a backbone alkoxysilane and a diazeniumdiolate-modified alkoxysilane. Further provided are methods of producing NO-releasing sol-gel coatings. Such methods may include (a) co-condensing a sol precursor solution comprising a backbone alkoxysilane and a diazeniumdiolate-modified alkoxysilane in a solvent to form a sol; (b) coating a substrate with the sol; and (c) drying the sol to form the NO-releasing sol-gel coating.

Abstract: Nanoparticles can be embedded into a medical device by accelerating them to a speed of between 100 m/s and 1,000 m/s and embedding the particles into a polymer surface of a medical device or a precursor thereof. In some cases, the nanoparticles can be embedded until the nanoparticles accumulate in sufficient number to adhere together to form a coating over the polymer surface. The nanoparticles can provide a conductive pathway, an abrasion resistant surface, a pro-healing surface, and/or an anti-bacterial surface.

Abstract: Methods and devices for the provision of a coating on an implantable medical device. 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 methods and devices provide a coating having improved uniformity and coverage which in turn allow for greater control of the amount and dosage of the coating.

Abstract: Implants having improved mechanical properties and/or degradation profiles, kits including such implants, and methods of producing and using the same.

Abstract: A coated implantable medical device and a method of coating an implantable medical device is disclosed, the method includes applying a composition onto the device and drying the composition at elevated temperature in an environment having increased relative humidity. A pre-screening method for a manufacturing lot of coated stents to determine the number of drug coating layers for a desired drug release rate is disclosed. The method including coating and testing small groups of stents, and applying the results of the tests to determine the number of drug coating layers to apply to the manufacturing lot of stents.

Abstract: Disclosed herein is an implantable medical device including an antimicrobial layer. The antimicrobial layer may include a first distinct size of silver nanoparticles, a second distinct size of silver nanoparticles, and a third distinct size of silver nanoparticles. The antimicrobial layer extends over a surface of the implantable medical device, and, in some instances, the surface of the implantable medical device may serve as a substrate on which the antimicrobial layer is deposited.

Abstract: An automated mandrel dip coating process assembly for RTV silicone dispersions is described, including an enclosure adapted to hold a moisture-cure ambient temperature curable medium for mandrel dip molding and at least one mandrel having a surface for contacting the moisture-cure ambient temperature curable medium. An automated motive drive assembly is arranged to removably translate one or more of the mandrel(s) into contact with the moisture-cure ambient temperature curable medium in the enclosure, and to subsequently translate at least one mandrel contacted with the moisture-cure ambient temperature curable medium into at least one of (A) contact with a bubble crusher in the enclosure, and (B) disengagement from the moisture-cure ambient temperature curable medium in the enclosure and rotation of the mandrel at a vertical displacement angle of from 70° to 110°.

Abstract: A medical device configured to be at least partially implanted within a host. The medical device includes an outer surface at least a portion of which is impermeable to cells but is permeable to molecules secreted by cells, the outer surface separating a space inside the medical device from a surrounding tissue of the host. The medical device also includes a diffusion sink positioned within the space and configured to cause molecules that are secreted into the tissue by immune cells during a foreign body response (FBR) to diffuse, through random motion, through the portion and into the diffusion sink.