Abstract: Methods for preparing a polymer-based stent assembly comprising an inflatable balloon catheter and a polymer-based stent resistant to relaxation-related negative recoil are provided.

Abstract: A system and method for treating a patient suffering from chronic hypertension. Electrical therapeutic energy is delivered to a nerve branch of a renal artery of the patient, thereby treating the chronic hypertension. Another system and method for treating a medical condition of a patient. Electrical stimulation energy is delivered to a stimulation site on the wall of a blood vessel, thereby evoking a compound action potential in a nerve branch associated with the blood vessel, sensing the evoked compound action potential at a sensing site on the wall of the blood vessel, identifying a circumferential location of the nerve branch as being adjacent the stimulation site or sensing site based on the sensed compound action potential(s), and delivering therapeutic energy to a therapeutic site on the wall of the blood vessel adjacent the circumferential location of the nerve branch, thereby modulating the nerve branch and treating the medical condition.

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

Abstract: Medical devices having a barrier layer comprising an inorganic material. The medical device has a reservoir containing a therapeutic agent and the barrier layer is disposed over the reservoir. In one aspect, the barrier layer has one permeability to the therapeutic agent at one portion of the medical device and a different permeability at another portion of the medical device. In another aspect, the dosage amount of the therapeutic agent in the reservoir at one portion of the medical device is different from the dosage amount of the therapeutic agent in the reservoir at another portion of the medical device. In another aspect, a bioresorbable layer is disposed over the barrier layer at one or more portions of the medical device, wherein the bioresorbable layer comprises a bioresorbable material. Also, methods of coating a medical device are disclosed, in which a barrier layer over a medical device is formed using a lithographic etching process where a plurality of particles serve as an etch mask.

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: Drug-delivery systems such as drug-delivery stents having an anti-proliferative agent such as everolimus and an anti-flammatory agent such as clobetasol are provided. Also disclosed are methods of treating a vascular impairment such as restenosis or vulnerable plaque.

Abstract: The present invention provides embodiments in which induced RF current heating along the length of a medical lead is reduced. Reduction of induced RF current heating in the medical lead is achieved by positioning a conductor about the exterior of an implantable medical device when the device is placed within an MRI environment. In one embodiment, an RF conductor is incorporated within a header assembly for connecting an implantable medical device to at least one conductor lead. The body of the RF conductor is positioned circumferentially around the implantable medical device. In another embodiment, the medical lead is positioned circumferentially around the exterior of the housing of the medical device. A series of clips or a sleeve holds the medical lead or RF conductor in place around the device.

Abstract: Disclosed are drug delivery systems comprising drugs admixed with polymers having drug solubility gradients and methods of making the polymers. Also disclosed are medical devices having coatings thereon comprising the drug solubility gradient-containing polymers and at least one drug.

Abstract: The invention relates to an endoprosthesis (1), in particular a vascular or cardiac endoprosthesis (1), having a body (2) and also one or more thrombogenic elements (3) that are fixed to the endoprosthesis (1) and that are able to extend a distance away from the body outside the latter. The endoprothesis comprises means (33) for selectively retaining the thrombogenic elements near the body (2). The release of the one or more thrombogenic elements, after the endoprosthesis has been fitted in place by a conventional method via a sheath, promotes thrombosis.

Abstract: A system for treating an aneurysm comprises at least a first double-walled filling structure having an outer wall and an inner wall and the filling structure is adapted to be filled with a hardenable fluid filling medium so that the outer wall conforms to the inside surface of the aneurysm and the inner surface forms a generally tubular lumen to provide blood flow. The first filling structure comprises a sealing feature which forms a fluid seal between the filling structure and the aneurysm or an adjacent endograft when the filling structure is filled with the hardenable fluid filling medium, thereby minimizing or preventing blood flow downstream of the seal.

Abstract: In accordance with certain embodiments of the present disclosure, a process of forming a prosthetic device is provided. The process includes forming a dispersion of polymeric nanofibers, a fiberizing polymer, and a solvent, the dispersion having a viscosity of at least about 50,000 cPs. A tubular frame is positioned over a tubular polymeric structure. Nanofibers from the dispersion are electrospun onto the tubular frame to form a prosthetic device. The prosthetic device is heated.

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

Abstract: The present invention relates to a process for reducing solvent contents in drug-containing polymeric compositions. Specifically, the solvent contents in the drug-containing polymeric compositions are first reduced by one or more conventional drying methods, to a range from about 0.5 wt % to about 10 wt % of the total weight of the polymeric composition. Subsequently, the drug-containing polymeric compositions are further treated by one or more low temperature (i.e., having processing temperatures of less than 60° C.) drying methods for further reduction of the solvent content to less than 10,000 ppm.

Abstract: The invention provides a stent made from a material operable to perform a stent's desired therapeutic functions, and also made from a material that has a radiopacity that substantially preserves the appearance of the stent when the stent is viewed under a CT imaging beam. Such a stent can allow for follow-up of the stent and the surrounding blood-vessel on CT.

Abstract: A drug-eluting stent, comprising a base body that is made of an implant material, the base body being partially or entirely covered on the abluminal side with an active ingredient-releasing coating that comprises or is made of a polymer and an active ingredient having an antiproliferative effect, characterized in that the stent's luminal surface and the abluminal surface carrying the active ingredient-releasing coating are covered by a biocorrodible protective layer in a form-fitting manner.

Abstract: An apparatus and system for delivering a lipophilic agent associated with a medical device including: a medical device, a first lipophilic agent capable of penetrating a body lumen, wherein the transfer coefficients of the first lipophilic agent is by an amount that is statistically significant of at least approximately 5,000, wherein the first lipophilic agent is associated with the medical device, wherein the first lipophilic agent/medical device is placed adjacent to said body lumen, and wherein a therapeutically effective amount of the first lipophilic agent is delivered to a desired area within a subject. Furthermore, the invention relates to a method for improving patency in a subject involving placement of a medical device in a body lumen for treating and/or preventing adjacent diseases or maintaining patency of the body lumen.

Abstract: A magnetic delivery system for delivering a magnetizable particle to a location in a body, the device includes a magnetizable object implanted in the body, wherein the magnetizable object includes a plurality of segments distributed throughout the magnetizable object and wherein the segments are configured to provide a magnetic gradient for attracting the magnetizable particle and an external source of a magnetic field capable of (i) magnetizing the magnetizable particle and (ii) increasing a degree of magnetization of the magnetizable object and thereby creating the magnetic gradient. A drug delivery system including the magnetic delivery system and a magnetizable particle associated with a therapeutic agent and/or a cell. A cell delivery system based on the magnetic delivery system and a magnetizable particle associated with a cell. A method of using the magnetic delivery system for delivery of a therapeutic agent and/or a cell to a targeted location in a body.

Abstract: A method for depositing a coating comprising a polymer and at least two pharmaceutical agents on a substrate, comprising the following steps: providing a stent framework; depositing on said stent framework a first layer comprising a first pharmaceutical agent; depositing a second layer comprising a second pharmaceutical agent; Wherein said first and second pharmaceutical agents are selected from two different classes of pharmaceutical agents.

Abstract: An implantable medical device (10) comprises reservoirs (30) for receiving a water-soluble active agent or medicament (36) in the form of a solid deposit; and at least one biocompatible and biodegradable protecting/retaining layer (38) for protecting the active agent or medicament (36) until it reaches its site of implantation, said biocompatible and biodegradable protecting layer (38) comprising at least one biocompatible and biodegradable film-forming agent, and at least one hydrophobic, biocompatible, agent for controlling the disintegration rate of the protecting/retaining layer. The invention provides better protection of the active agent or medicament and better control of the disintegration rate of the protecting/retaining layer.

Abstract: An endoprosthesis comprising a stent, a cover fully covering the stent wherein the cover has variable porosity in the radial direction; and an adhesion layer connecting the stent to the cover. Another aspect of the invention is a method of implanting an endoprosthesis which includes a stent, providing a cover with variable porosity in the radial direction, connecting the stent to the cover with an adhesion layer to form a covered stent, and implanting the covered stent within a body lumen of a patient.

Abstract: Stents and methods of fabricating stents with prohealing layers and drug-polymer layers are disclosed.

Abstract: Multi-sheet laminate structures having a first extracellular matrix (ECM) sheet member having a biomaterial composition disposed on first ECM sheet member top surface and a second ECM sheet member having a bottom surface, the second ECM sheet member being joined to the first ECM sheet member, wherein the first ECM sheet member top biomaterial composition surface is disposed proximate the second ECM sheet member bottom surface.

Abstract: A stent is formed from a wire having an outer member, a radiopaque member lining at least a portion of the outer member inner surface, and a lumen defined by the outer member inner surface or the radiopaque member inner surface. A substance is disposed in the lumen to be eluted through at least one opening disposed through the outer member to the lumen. The radiopaque member may be substantially continuous along the length of the wire or disposed only along portions of the wire such as crowns. In a method for making the stent, a composite wire including an outer member, a radiopaque intermediate member, and a core member is shaped into a stent pattern and processed to remove the core member and optionally portions of the radiopaque intermediate member, without damaging the outer member.

Abstract: Methods of treating the polymeric surfaces of a stent with a fluid including a solvent for the surface polymer are disclosed.

Abstract: The present invention relates generally to the maintenance of blow flood using drug eluting stents and/or other coated medical devices to increased length of time of blood flow. Further, the present invention relates to drug-releasing coated devices for reducing smooth muscle cell proliferation and platelet activity to further limit restenosis utilizing resveratrol and quercetin, polyphenols that are linked to the cardioprotection of red wine consumption. The present invention also provides products and methods for treating or preventing atherosclerosis, stenosis, restenosis, smooth muscle cell proliferation, platelet cell activation and other clotting mechanisms, occlusive disease, or other abnormal lumenal cellular proliferation condition in a location within the body of a patient.

Abstract: The present invention relates generally to the maintenance of blow flood using drug eluting stents and/or other coated medical devices to increased length of time of blood flow. Further, the present invention relates to drug-releasing coated devices for reducing smooth muscle cell proliferation and platelet activity to further limit restenosis utilizing resveratrol and quercetin, polyphenols that are linked to the cardioprotection of red wine consumption. The present invention also provides products and methods for treating or preventing atherosclerosis, stenosis, restenosis, smooth muscle cell proliferation, platelet cell activation and other clotting mechanisms, occlusive disease, or other abnormal lumenal cellular proliferation condition in a location within the body of a patient.

Abstract: In accordance with certain embodiments of the present disclosure, a process of forming a prosthetic device is provided. The process includes forming a dispersion of polymeric nanofibers, a fiberizing polymer, and a solvent, the dispersion having a viscosity of at least about 50,000 cPs. A tubular frame is positioned over a tubular polymeric structure. Nanofibers from the dispersion are electrospun onto the tubular frame to form a prosthetic device. The prosthetic device is heated.

Abstract: A synthetic construct suitable for implantation into a biological organism that includes at least one polymer scaffold; wherein the at least one polymer scaffold includes at least one layer of polymer fibers that have been deposited by electrospinning; wherein the orientation of the fibers in the at least one polymer scaffold relative to one another is generally parallel, random, or both; and wherein the at least one polymer scaffold has been adapted to function as at least one of a substantially two-dimensional implantable structure and a substantially three-dimensional implantable tubular structure.

Abstract: A drug-delivering insertable medical device for treating a medical condition associated with a body lumen is disclosed. The drug-delivering insertable medical device includes an outer surface coated with two or more nano-carriers having two or more average diameters. A nano-carrier of the two or more nano-carriers has an average diameter suitable for penetrating one or more layers of two or more layers of the body lumen. The nano-carrier includes a drug surrounded by an encapsulating medium. The encapsulating medium includes one or more of a biological agent, a blood excipient, and a phospholipid.

Abstract: A system for delivery of a beneficial agent in the form of a viscous liquid or paste allows holes in a medical device to be loaded in a single step process. The loading of a beneficial agent in a paste form also provides the ability to deliver large and potentially sensitive molecules including proteins, enzymes, antibodies, antisense, ribozymes, gene/vector constructs, and cells including endothelial cells.

Abstract: Coating methods and related devices are provided. Such devices can include stents. For example, the device can comprise a sidewall and a plurality of pores in the sidewall that are sized to inhibit flow of blood through the sidewall into an aneurysm to a degree sufficient to lead to thrombosis and healing of the aneurysm when the tubular member is positioned in a blood vessel and adjacent to the aneurysm. The device can also comprise an anti-thrombogenic coating distributed over at least a portion of the device such that the pores are substantially free of webs formed by the coating.

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: A biocompatible plasticizer useful for forming a coating composition with a biocompatible polymer is provided. The coating composition may also include a biobeneficial polymer and/or a bioactive agent. The coating composition can form a coating on an implantable device. The implantable device can be used to treat or prevent a disorder such as atherosclerosis, thrombosis, restenosis, hemorrhage, vascular dissection or perforation, vascular aneurysm, vulnerable plaque, chronic total occlusion, claudication, anastomotic proliferation for vein and artificial grafts, bile duct obstruction, ureter obstruction, tumor obstruction, or combinations thereof.

Abstract: The present invention is directed to a bio-functionalized stimulus-responsive dissolvable PEG-hydrogel. This inventive stimulus-responsive dissolvable PEG-hydrogel comprises a matrix of PEG-polymers, which are modified to contain at least one multifunctional fusion protein, the multifunctional fusion protein preferably comprising as components a substrate binding peptide (SBP), preferably a repetitive RGD-binding peptide and/or a ZZ-binding domain, preferably a tag for purification, and at least one N- and/or C-terminal linker. The present invention is furthermore directed to the use of such inventive stimulus-responsive dissolvable PEG-hydrogels in the treatment of lesions, in surgical dressings, for wound treating, for soft and hard tissue regeneration, for the treatment of wounds in the oral cavity, in the field of ophthalmology, in the field of periodontal defects, etc. The invention also describes a method of treatment for such diseases.

Abstract: Absorbable stents and absorbable stent coatings have been developed with improved properties. These devices preferably comprise biocompatible copolymers or homopolymers of 4-hydroxybutyrate, and optionally polylactic acid and other absorbable polymers and additives. Compositions of these materials can be used to make absorbable stents that provide advantageous radial strengths, resistance to recoil and creep, can be plastically expanded on a balloon catheter, and can be deployed rapidly in vivo. Stent coatings derived from these materials provide biocompatible, uniform coatings that are ductile, and can be expanded without the coating cracking and/or delaminating and can be used as a coating matrix for drug incorporation.

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: The invention provides a system, device and method for localized application of therapeutic substances within a biological conduit. In various embodiments, a dissolvable bag or bolus of at least one therapeutic agent is introduced and pressed and/or sealed against the wall of conduit. In other embodiments, dissolvable barbs formed from at least one therapeutic agent are ejected from a catheter by fluid pressure, embedding in the wall of conduit.

Abstract: The invention relates to a method for producing a bioactive surface on the balloon (3) of a balloon catheter (1). According to said method, the surface of the balloon (3) is at least partially wetted with a first solution of an active substance (8) and the section of the surface of the balloon (3) wetted with the first solution of an active substance (8) is then wetted with a second, saturated solution of the active substance (28). The invention further relates to a balloon (3) of a balloon catheter (1) the surface of which is at least partially coated with an active substance (11), the coating (11) being homogeneous and brittle in the entire coated region.

Abstract: An implant having a preferably hollow cylindrical main structure comprising a large number of continuous openings and a coating which releases at least one pharmaceutically active substance. To attain a better distribution of the pharmaceutically active substance, at least 20% of the cross-sectional area, preferably at least 50% of the cross-sectional area, of at least a portion of the openings in a predetermined section of the main structure is covered with the coating which releases at least one pharmaceutically active substance. Furthermore, a system composed of a catheter and such an implant, a simple method for manufacturing such an implant or such a system is provided.

Abstract: Described herein are methods and systems that can be used to induce immunologic tolerance to non-self antigens. The methods and systems comprise introducing a tolerogen comprising at least one immunogenic non-self antigen coupled to a carrier, wherein the immunogenic antigen can be a foreign or endogenous antigen or fragments thereof. The non-self antigen can be selected from the group consisting of carbohydrate antigens, full-length antigenic proteins, and fragments and combinations thereof, while the carrier can be selected from nanoparticles and stents. Tolerogen compositions are also provided and can be used to induce immunologic tolerance to non-self antigens. These methods, systems and compositions are particularly advantageous since they can be used to allow for the extension of the window of safety for immunologically-incompatible transplantations to patients who are growing past the age of infancy.

Abstract: The present invention relates to covered endoprosthetic devices. Covered endoprosthetic devices comprise an endoprosthesis and a sheath. The sheath comprises a central portion and outer portions, wherein the central portion preferentially restricts or causes a restriction of blood flow. Blood flow can be reduced by the central portion of the sheath by varying the permeability of the sheath or by having projections on the sheath that slow blood flow. Permeability may be provided by perforations or holes in the material of the sheath or by varying the polymer structure that makes up the sheath itself. The outer portions of the sheath do not substantially reduce blood flow. Methods of using sheath-covered endoprosthetic devices of the invention to treat aneurysms, especially aneurysms in proximity to small perforator vessels or arteries, are also encompassed.

Abstract: A coating composition for drug-eluting medical devices, which enables a medical device to be delivered to a target tissue for the purpose of treating an affected blood vessel part such as restenosis, without easy separation of a drug from the medical device during the delivery process is provided. The coating composition for drug-eluting medical devices contains a water-insoluble drug and at least one selected from the group consisting of ester compounds of amino acids, which have a hydropathy index of the amino acid of zero or less than zero, and salts thereof. A drug coating layer, a drug-eluting medical device and a method of treatment are also provided.

Abstract: A coating composition for drug eluting medical devices, which is capable of forming a drug coating layer that is not susceptible to peeling during delivery to a target tissue is provided. This coating composition contains: a water-insoluble drug; at least one selected from the group consisting of hyaluronic acid, alkanoyl hyaluronic acids obtained by substituting at least part of hydrogen atoms in the hydroxyl groups of hyaluronic acid with an alkanoyl group, and salts of hyaluronic acid and the alkanoyl hyaluronic acids; and at least one selected from the group consisting of amino-acid esters and salts thereof. A drug coating layer, a medical device and a method of treatment are also provided.

Abstract: The present invention relates to tubular stents that are implanted within a body lumen. The stent has a cylindrical shape defining a longitudinal axis and includes a proximal helical section, a distal helical section and an intermediate ring section there between. Each of the proximal and distal helical sections has of a plurality of longitudinally oriented strut members and a plurality of circumferentially oriented hinge members connecting circumferentially adjacent strut members to form a band, the band being wrapped about the longitudinal axis in a substantially helical manner to form a plurality of helical windings, wherein the distal helical section is wound about the longitudinal axis in the opposite direction from the proximal helical section. The intermediate ring section includes a plurality of longitudinally oriented strut members and a plurality of circumferentially oriented hinge members connecting circumferentially adjacent strut members to form an endless ring.

Abstract: The present invention relates to implantable medical devices coated with polymer having tunable hydrophobicity and their use in the treatment of vascular diseases.

Abstract: Absorbable stents and absorbable stent coatings have been developed with improved properties. These devices preferably comprise biocompatible copolymers or homopolymers of 4-hydroxybutyrate, and optionally poly-L-lactic acid and other absorbable polymers and additives. Compositions of these materials can be used to make absorbable stents that provide advantageous radial strengths, resistance to recoil and creep, can be plastically expanded on a balloon catheter, and can be deployed rapidly in vivo. Stent coatings derived from these materials provide biocompatible, uniform coatings that are ductile, and can be expanded without the coating cracking and/or delarmnating and can be used as a coating matrix for drug incorporation.

Abstract: A method of coating a stent is presented such that less than 50% of the total amount of 40-O-(2-hydroxyl)ethyl-rapamycin, or an analog or derivative thereof, is released in vivo in a 24 hour period, wherein the method comprises exposing the coating to sufficient temperature to modify the structure of the polymer.

Abstract: A medical implant includes a metallic base, a tie layer, and at least a first layer overlying an outer surface of the tie layer. The tie layer is bonded to at least a portion of a surface of the metallic base. The tie layer includes magnesium or a magnesium-based alloy. The tie layer can have an outer surface comprising dendritic grains. The tie layer can have a rough outer surface defined by pores, projecting grain structures, and/or projecting particles. A method of producing a tie layer on a medical device includes applying magnesium or a magnesium-based alloy to the medical device and cooling the magnesium or the magnesium-based alloy to produce a rough outer surface.

Abstract: The present invention relates to the regional delivery of therapeutic agents for the treatment of vascular diseases wherein regional delivery refers to delivery of a therapeutically effective amount of the therapeutic agent to an area of the vessel that includes not only afflicted tissue but non-afflicted tissue at the periphery of the afflicted tissue as well.

Abstract: Methods of making a coating on a medical device are disclosed, including associating a composition with at least a portion of the device to form a layer. In some embodiments, a composition may include a copolymer prepared from a room temperature melt of a plurality of monomer units that comprises a first monomer unit and a second monomer unit, wherein the second monomer unit has a glass transition temperature that is at least about 30 degrees Centigrade higher than the glass transition temperature of the first monomer unit, with a glass transition temperature of a monomer unit being defined as a glass transition temperature of a homopolymer of that monomer unit.