Abstract: The invention relates to surface modifying macromolecules (SMMs) having high degradation temperatures and their use in the manufacture of articles made from base polymers which require high temperature processing. The surface modifier is admixed with the base polymer to impart alcohol and water repellency properties.

Abstract: The present invention is generally directed to implantable medical devices for delivering therapeutic agents to the body tissue of a patient and methods for making such medical devices. In particular, the present invention is directed to implantable medical devices, such as intravascular stents, having a surface that includes a plurality of cavities and a plurality of pores and a composition disposed in the pores and/or cavities, as well as, implantable medical devices, such as intravascular stents, having a surface that has a coating composition disposed on the surface, wherein the coating composition includes a plurality of cavities and a plurality of pores and another coating composition disposed in the pores and/or cavities.

Abstract: A method for guiding stent deployment during an endovascular procedure includes providing a virtual stent model of a real stent that specifies a length, diameter, shape, and placement of the real stent. The method further includes projecting the virtual stent model onto a 2-dimensional (2D) DSA image of a target lesion, manipulating a stent deployment mechanism to navigate the stent to the target lesion while simultaneously acquiring real-time 2D fluoroscopic images of the stent navigation, and overlaying each fluoroscopic image on the 2D DSA image having the projected virtual stent model image, where the 2D fluoroscopic images are acquired from a C-arm mounted X-ray apparatus, and updating the projection of the virtual stent model onto the fluoroscopic images whenever a new fluoroscopic image is acquired or whenever the C-arm is moved, where the stent is aligned with the virtual stent model by aligning stent end markers with virtual end markers.

Abstract: Devices for assessing the size, shape, and topography of vessel lumens and hollow portions of organs are described. The devices are particularly adapted for determining the size, shape, topography, and compliance of the native heart valves to facilitate the later implantation of a prosthetic heart valve. The devices are typically catheter-based having an assessment mechanism fixed to a distal end of the catheter. The assessment mechanism generally includes an expandable member, such as a balloon. The assessment mechanism may also include an imaging member, a physical assessment member, an electronic mapping construction, an alignment mechanism, a valvuloplasty balloon, or any combination thereof.

Abstract: A device resonator for medical device is provided. The resonator device includes a helical structure and a capacitor structure. The resonator device can be used in conjunction with a medical device, including a stent.

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

Abstract: A sleeve device, system and method are provided for restricting and/or constricting aneurysms. More particularly, a sleeve and/or a double-walled sleeve is located in or on a vessel in the location of an aneurysm. When placed around the outside of a vessel, is used to constrict the aneurysm containing portion of the vessel. Optionally, a saddle portion can be disposed outside of the vessel to hold the sleeve in a desired location. When placed inside the vessel, the sleeve is provided to bypass blood flowing through the aneurysm. If desired, the sleeve may be constructed as a double-walled sleeve that can be inflated to apply pressure to and/or in the vessel.

Abstract: A generally tubular, cylindrical stent prosthesis has an unexpanded delivery configuration and an expanded configuration for contacting the vessel wall. The stent prosthesis has a plurality of adjacent stent struts, each stent strut having a wavelike or sinusoidal pattern of straight segments and crowns. A Y-shaped member is attached to one or more crowns to cause the crowns to flare outwardly at an angle from the cylindrical stent body when the stent is expanded. Upon expansion of the stent, the crown(s) having Y-shaped members attached thereto are angled with respect to the longitudinal axis and radially flare from the cylindrical stent body. The flared crowns anchor the stent within the vessel by protruding into the vessel wall and/or seating the stent within an ostium.

Abstract: Methods are provided for surface modifying a hydrophobic polymer substrate to increase wettability comprising the steps of pre-treating the hydrophobic polymer substrate with a radio frequency (RF)-generated first plasma and a RF-generated second plasma wherein the first plasma and the second plasma are applied sequentially, coating the hydrophobic polymer substrate with a hydrophilic coating; and polymerizing the hydrophilic coating on the hydrophobic polymer substrate by exposure to a RF-generated third plasma.

Abstract: An endoprosthesis such as a stent is composed of a metal or ceramic, such as Irox, embedded in the stent material.

Abstract: There is disclosed an insert (2) for a conduit (4) adapted to effect helical flow in the conduit (4) comprising a longitudinally extending member having a helical formation.

Abstract: The invention provides methods for stabilizing the femoral artery.

Abstract: A machine and process useful for processing a delicate workpiece, e.g., an implantable medical device, includes a carrier having a mandrel and wheels. The workpiece is positioned on the mandrel, which is free to roll by gravity on rails which cooperate with the wheels to self-align the travel of the carrier. The carrier can move the workpieces through a series of processing steps by gravity feed and without human intervention. A laterally movable carriage receives the rolling carriers and moves the carrier for processing, and returns the carrier to the rails to again roll by gravity to another processing substation for additional processing. An elevator, which can including processing units itself, is positioned along the rails to receive carriers and raise them so they can continue to roll for further processing.

Abstract: 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.

Abstract: A method of making a filter is disclosed including providing a mandrel, positioning a filter form on the mandrel, the filter form including a dissolvable compound, disposing a filter basket over the filter form, dissolving the filter form, and removing the mandrel from the filter basket.

Abstract: A medical implant for occluding a blood vessel. The medical implant comprises a cup shaped elastic blood impermeable membrane sized and shaped for substantially occluding a lumen of a blood vessel, at least one scaffolding element mounted, sized and shaped for being attached at least one blood clot forming in front of the elastic blood impermeable membrane, and at least one anchoring element having a tip directed outward from the center of the cup shaped elastic blood impermeable membrane.

Abstract: A wrap (20) for securing about a blood vessel (36) by encasing a section of the vessel. The wrap (20) being of thin flexible construction having two ends (22, 24) and two sides (26, 28). The wrap (20) is more elastic or stretchable at, near, or along at least some of its sides (22, 24) compared to at, near, or along its centre, to provide strain relief from wrapped to unwrapped aorta. The wrap (20) is not inelastic, so that loss of aortic compliance is minimised or enhanced. The wrap (20) is adapted to apply, in use, less compressive force at, near, or along at least some of its sides (22, 24) compared to at, near, or along its centre.

Abstract: The present invention provides methods of making covalently crosslinked vinyl polymer hydrogels having advantageous physical properties, and covalently crosslinked vinyl polymer hydrogel compositions made by such methods, as well as articles of manufacture comprising such covalently crosslinked vinyl polymer hydrogel compositions. The physical properties of the produced hydrogels can be adjusted by varying controlled parameters such as the proportion of physical associations, the concentration of polymer and the amount of radiation applied. Such covalently crosslinked vinyl polymer hydrogels can be made translucent, preferably transparent, or opaque depending on the processing conditions. The stability of the physical properties of the produced vinyl polymer hydrogel can be enhanced by controlling the amount of covalent crosslinks.

Abstract: A plaque tack device for treating atherosclerotic occlusive disease is formed as a thin, annular band made of thin, flexible wire formed in a mesh structure having a plurality of barbs on its outer periphery. It has a width that is small relative to its diameter, to minimize the amount of foreign structure placed in the blood vessel. One or more tacks may be applied in positions along a plaque accumulation site as needed to stabilize the site and/or hold pieces of plaque out of the way of blood flow. The barbs of the tack may be pressed into the plaque and/or blood vessel walls by balloon expansion. Related methods of deployment and delivery devices are provided for insertion of the plaque tack in a compressed state into the blood vessel and expanding it back to its annular shape for holding plaque against the blood vessel walls.

Abstract: It has been determined that gamma sterilization of biodegradable polymer stents does not cause significant polymer cross-linking and collapse. Using sufficient spacing can lead to stents that display little if any detrimental effects from the procedure. In certain embodiments, using structures in the general region of about 100 micron spacing between the struts leads to highly functional stents that do not fuse. Further, the resulting stent has radially homogenous mechanical properties. Therefore, the stent has a uniform expansion within the lumen.

Abstract: An implantable medical device is disclosed comprising a high-density lipoprotein (HDL), recombinant HDL, high-density lipoprotein mimics (HDLm), or a combination thereof. Method are also disclosed for local and systemic administration HDL, recombinant HDL or HDLm for the prevention, treatment, or amelioration of a vascular disorder, disease or occlusion such as restenosis or vulnerable plaque.

Abstract: The invention is directed to an expandable stent for implantating in a body lumen, such as a coronary artery, peripheral artery, or other body lumen. The invention provides for a an intravascular stent having a plurality of cylindrical rings connected by undulating links. The stent has a high degree of flexibility in the longitudinal direction, yet has adequate vessel wall coverage and radial strength sufficient to hold open an artery or other body lumen.

Abstract: In one aspect the present invention provides medical devices 10 that each include a plurality of fibers 22, substantially all of the plurality of fibers 22 each including a portion having a maximum diameter of at least five micrometers, wherein substantially all of fibers 22 form a layer on at least one external surface of medical device 10. In another aspect, the present invention provides methods of manufacturing medical devices 10, the methods including the steps of: (a) applying a layer comprising a plurality of fibers 22 to at least one surface of medical device 10; and (b) matching the value of the Young's modulus of the layer to +/?35% (in some embodiments to +/?20%) of the value of the Young's modulus of an animal tissue.

Abstract: A therapeutic medical article is provided which comprises a medical article, a precursor compound and an activator compound. The medical article is adapted, upon administration to a patient, to release the precursor compound and the activator compound such that the activator compound interacts with the precursor compound and converts the precursor compound into activated form for local delivery. Specific examples of precursor and activator compound pairs include: (a) a nitrosothiol precursor and a nitric oxide donor, (b) plasminogen and plasminogen activator, and (c) fibrinogen and thrombin.

Abstract: Described are percutaneous vascular valves free of attached support structures and deployment systems and methods for providing attachment of the valves within a vascular vessel.

Abstract: A prosthetic aortic conduit for replacing a root portion of an aorta is provided. The conduit comprises a continuous tubular conduit along a substantially common axis. A portion of the tubular conduit does not substantially deform in a longitudinal direction and has resilient means which allow said another portion of the conduit to be expandable in a lateral direction. The portion that is able to deform laterally mimics the function of the sinuses of Valsalva. The method of manufacturing such a conduit comprises the steps of having a continuous weave of rows of yarn or the equivalent with a change in tightness of the rows so that in some portion of the conduit it is expandable in the lateral direction and in some portion of the conduit it is expandable in the longitudinal direction.

Abstract: A stent with strut bands and connectors, wherein the strut bands have long and short struts with a junction positioned between the short struts. Each junction defines a reservoir, wherein the reservoirs of a strut band are substantially circumferentially aligned. The connectors each have arms, wherein each arm includes an opposing U-shaped link. The opposing links have a shared portion disposed between a peak on one strut band and a longitudinally adjacent trough of an adjacent strut band.

Abstract: Apparatus and methods are described, including identifying a subject as suffering from hypertension. In response to the identifying (a) a radius of curvature of a first set of at least three regions of an arterial wall of the subject is increased at a given longitudinal location, while (b) allowing the first set of regions of the arterial wall to pulsate. A device is implanted inside the artery at the longitudinal location such that the device applies pressure to the arterial wall at a second set of at least three regions of the artery, but does not contact the first set of regions, the first set of regions and the second set of regions alternating with each other. Other embodiments are also described.

Abstract: According to an aspect of the present invention, implantable or insertable medical devices are provided, which contain one or more polymeric regions. These polymeric regions, in turn, contain one or more polymers, at least one of which is a copolymer that includes a styrene monomer and an isobutylene monomer. Moreover, the styrene monomer content of the copolymer typically ranges from 25 to 50 mol %.

Abstract: Implantable devices (e.g., stent) having a protein patterning or bioactive patterning for accelerated healing and method of forming and using the same are provided.

Abstract: This disclosure provides a medical device and a method of forming the medical device. The medical device comprises a coating comprising a type-one polymer and a type-two polymer. The type-one polymer comprises at least two different blocks, at least one L1 block with the formula ; and at least one L2 block with the formula Medical devices comprising these polymers, mixtures of these polymers with therapeutic agents, and methods of making these polymers and mixtures are within the scope of this disclosure.

Abstract: An implant comprises a structure that may be implanted into tissue and that has a first material property at normal body temperature. The first material property is variable at elevated temperatures above normal body temperature. The implant also has a plurality of particles dispersed in the structure that are adapted to convert incident radiation into heat energy when irradiated with electromagnetic radiation. The particles are in thermal contact with the structure such that exposure of the particles to incident radiation raises the temperature of the structure thereby changing the first material property relative to the first material property at normal body temperature.

Abstract: This disclosure relates to endolumenal medical devices coated with a taxane therapeutic agent in one or more solid form(s) having varying dissolution rates. Particularly preferred coatings comprise amorphous paclitaxel, dihydrate paclitaxel, or combinations thereof that provide durable coatings that release paclitaxel over a desired period of time, which can be on the order of hours, days or weeks. Preferred embodiments relate to medical device coatings of paclitaxel, or paclitaxel analogs or derivatives, having one or more polymorph solid forms that provide a prolonged release of paclitaxel within a body vessel without requiring a polymer carrier or barrier layer to achieve the desired rate of paclitaxel elution.

Abstract: An adjustable stenosis provides a channel comprising an outer wall and an inner wall. The inner wall may comprise resiliently flexible material. A reservoir may be formed by the outer wall and inner wall. The flexibility of the inner wall allows the reservoir to expand into the channel to increase stenosis and to contract toward the outer wall to decrease stenosis. The reservoir may have a default expanded shape or a default contracted shape. The default shape may be maintained unless the pressure or amount of filler material in the reservoir is manipulated. The reservoir may have one or more chambers. The channel may be attached to a natural lumen or a graft or may be placed around the lumen or graft.

Abstract: Biocompatible phase invertable proteinaceous compositions and methods for making and using the same are provided. The subject phase invertable compositions are prepared by combining a proteinaceous substrate and a cross-linker. The proteinaceous substrate includes one or more proteins and an adhesion modifier, and may also include one or more of: a plasticizer, a carbohydrate, or other modification agent. In certain embodiments, the cross-linker is a heat-treated dialdehyde, e.g., heat-treated glutaraldehyde. Also provided are kits for use in preparing the subject compositions. The subject compositions, kits and systems find use in a variety of different applications.

Abstract: A system and method that minimizes plaque accumulation on a stent and thereby restenosis that could require a subsequent invasive medical procedure following implantation of the stent in a patient. A plurality of electrically-powered, biocompatible devices, implantable via injection, are positioned within the patient proximate to the stent and under control of a externally-placed controller are commanded to emit ultrasonic waves corresponding to the mechanical resonance of the stent. By controlling the frequency and the relative phases of the ultrasonic waves, the accumulation of plaque on the stent can thus be minimized.

Abstract: The present invention relates to an endoprosthesis having a plurality of web rings coupled by connectors, which include two or more essentially parallel struts and a foot extension protruding from one of the struts. An endoprosthesis constructed according to the principles of the present invention provides an elevated degree of scaffolding to a body lumen while retaining an acceptable degree of flexibility.

Abstract: Shunt devices and a method for continuously decompressing elevated intraocular pressure in eyes affected by glaucoma by diverting excess aqueous humor from the anterior chamber of the eye into Schlemm's canal where post-operative patency can be maintained with an indwelling shunt device which surgically connects the canal with the anterior chamber. The shunt devices provide uni- or bi-directional flow of aqueous humor into Schlemm's canal.

Abstract: Various embodiments of the present invention provide a conduit device including an attaching device configured for defining a helical pathway through a tissue wall and complementary ring in cooperation for securing the device within an aperture defined in the tissue wall. Some embodiments of the present invention further provide a system for implanting a conduit device in a tissue wall. More specifically, some embodiments provide a system including a coring device for defining an aperture in a tissue by removing and retaining a tissue core and securely implanting a conduit device therein so as to provide fluid communication between a first and second surface of the tissue wall via the conduit device.

Abstract: A joint and method for producing a joint in an endovascular graft. In one embodiment, a flap of a flexible material portion of an endovascular graft is folded about a portion of an expandable member to form a loop portion. The flap is secured in the loop configuration so that tensile force on the expandable member is transferred into a shear force on the fixed portion of the flap.

Abstract: A system for treating atherosclerotic cardiovascular disease and cardiac valve dysfunction comprises delivering one or more calcium chelating agents locally to a treatment site. One aspect of the invention provides a method including delivering a nano-particulate calcium chelating agent into a vascular wall. Another aspect of the invention provides a method and device for forming a sealed chamber around a cardiac valve, releasing one or more calcium chelating agents into the sealed chamber and decalcifying a cardiac valve in need thereof.

Abstract: The invention relates to materials comprising polymer network containing siloxanes or organic-based core structures, preferably the materials have thermal-responsive properties. In some embodiments, the invention relates to an organic core functionalized with polymers. In another embodiment, organic core-polymer conjugates comprise polylactone segments. The organic core-polymer conjugates may be crosslinked together to form a material, and these materials may be functionalized with bioactive compounds so that the materials have desirable biocompatibility or bioactivity when used in medical devices. In some embodiments, the invention relates to silsesquioxane groups functionalized with polymers. In another embodiment, silsequioxane-polymer conjugates comprise polylactone segments.

Abstract: The invention provides method of fabricating a scaffold comprising a fluidic network, including the steps of: (a) generating an initial vascular layer for enclosing the chamber and providing fluid to the cells, the initial vascular layer having a network of channels for fluid; (b) translating the initial vascular layer into a model for fluid dynamics analysis; (c) analyzing the initial vascular layer based on desired parameters selected from the group consisting of a characteristic of a specific fluid, an input pressure, an output pressure, an overall flow rate and combinations thereof to determine sheer stress and velocity within the network of channels; (d) measuring the sheer stress and the velocity and comparing the obtained values to predetermined values; (e) determining if either of the shear stress or the velocity are greater than or less than the predetermined values, and (f) optionally modifying the initial vascular layer and repeating steps (b)-(e).

Abstract: Disclosed herein are implantable medical devices comprising controlled release terpolymers and at least one drug releasable from said terpolymers coating. The terpolymers of the present invention are comprised of acrylate and/or vinyl monomers.

Abstract: Methods, apparatuses, computer program products, devices and systems are described that include accepting one or more blood vessel sleeve dimensions based on blood vessel data from an individual; and making a rapid-prototyped blood vessel sleeve at least partly based on the one or more blood vessel sleeve dimensions.

Abstract: A treatment assembly is positioned along an AV-fistula and couples therapeutic energy to an adjacent area due to a material response to an applied energy field from a remotely located energy source. The treatment assembly may be delivered into the fistula through a hemodialysis needle, or may be secured to the fistula graft itself and implanted therewith in a patient. A cover provides a shield between an anastomosis area and blood flow. Another AV-fistula includes a valved reservoir that receives a fluid agent from a hemodialysis needle while moving the needle into or from the fistula; the agent leaks from the reservoir into the fistula lumen. Another valved fistula is adjustable between an open condition and closed conditions during and between hemodialysis treatments, respectively. Another AV-fistula has a bladder reservoir coupled to a second refillable fluid reservoir and is adapted to locally deliver a therapeutic agent into the fistula lumen.

Abstract: A method of manufacturing an implantable medical device, such as a drug eluting stent, is disclosed. The method includes subjecting an implantable medical device that includes a polymer to a thermal condition. The thermal condition can result in reduction of the rate of release of an active agent from the device subsequent to the implantation of the device and/or improve the mechanical properties of a polymeric coating on the device.

Abstract: The present invention relate to a balloon expandable stent mounted on a balloon catheter, the entire assembly being overcoated with a coherent polymer coating, which is preferably substantially continuous over the circumference and, more preferably, axial length of the stent on the balloon. The polymer coating improves retention of the stent on the balloon during delivery and does not adversely effect the deployment characteristics, nor the balloon failure characteristics. The product is made by mounting the stent on the balloon and coating the assembly with a liquid coating composition containing a suitable polymer followed by curing of the coating. The polymer is biocompatible and preferably crosslinkable in the coating composition, and crosslinked in the final product. A suitable polymer is formed from monomers including a zwitterionic, preferably a phosphoryl choline, group, and monomers including a trialkoxysilyl group.

Abstract: The ePTFE structure includes an ePTFE tubular structure having opposite ends and a longitudinal axis. The ePTFE tubular structure is formed from rotating the opposite ends relative to one another in a direction of rotation about the longitudinal axis. The ePTFE tubular structure has a node and fibril micro-structure in which substantially all of the fibrils are oriented in the direction of rotation.

Abstract: An endovascular bypass graft includes a tubular member, a first expandable mesh stent attached to one end of the tubular member, and a second expandable mesh stent attached to an opposite end of the tubular member. The second stent is provided with a plurality of fenestrations. The graft is inserted into a principal blood vessel such as the aorta and positioned in the vessel so that the fenestrations are aligned with junctions with ancillary blood vessels. The graft is attached to the principal blood vessel so that the fenestrations remain aligned with the respective junctions, thereby allowing blood flow between the principal vessel and the auxiliary vessels through the respective junctions upon completion of the bypass operation.