Abstract: Coatings including adhesion factors for the surfaces of implantable medical articles are disclosed. The coatings are used to improve the function of the device by promoting a pro-healing response following implantation. The coatings can modulate endothelialization of the article surface to reduce the risk of adverse tissue responses that may reduce the functionality of the device.

Abstract: Coatings are provided in which surfaces may be activated by covalently bonding a silane derivative to the metal surface, covalently bonding a lactone polymer to the silane derivative by in situ ring opening polymerization, and depositing at least one layer of a polyester on the bonded lactone. Biologically active agents may be deposited with the polyester layers. Such coated surfaces may be useful in medical devices, in particular stents.

Abstract: According to an aspect of the present invention, long term medical articles are provided which include the following: (a) first and second body contacting (e.g., tissue and/or body-fluid contacting) porous polymeric layers; (b) a polymeric barrier layer disposed between the first and second porous polymer layers; and (c) a reinforcement element. According to another aspect of the present invention, tubular medical articles for long term implantation are provided, which comprise: (a) a reinforcement element; (b) a blood contacting porous polymeric layer having a surface energy ranging between 20 and 30 dynes/cm disposed over an inner surface of the reinforcement element; and (c) an additional porous polymeric layer formed over an outer surface of the reinforcement element.

Abstract: A vascular prosthesis having a tubular structure is provided. The tubular structure is fabricated from at least two layers wherein at least one layer includes a thrombogenic agent.

Abstract: A medical device for implantation in a vessel is disclosed. The medical device comprises at least one anastomotic member, at least partially interposing a non-woven liner of electrospun fibers and a non-woven cover of electrospun fibers. The at least one anastomotic member is designed for engaging at least one end of the medical device to a wall of the vessel upon implantation of the medical device within the vessel.

Abstract: An anti-restontic device is provided for repairing a tissue, particularly an arteriosclerosed blood vessel or a damaged wall of a luminal or chambered organ. In some embodiments, the device comprises a structure having a first surface and a second surface. A bioactive layer is disposed on the first surface, wherein the bioactive layer enhances growth of a type of cells thereon. And an anti-restenosis layer is disposed on the second surface, wherein the anti-restenosis layer inhibits growth of another type of cells thereon.

Abstract: A biocompatible non-memory expandable polymeric article selected from stents, implantable prostheses, catheters, other surgical articles and sealants for implantable prostheses, and which is at least in part biodegradable and includes a combination where hollow cylindrical element (2) is depicted in cutaway form to reveal helical element (4), terminated schematically at (6) and where a combination of at least one thermoplastic elastomeric component and at least one thermoplastic non-elastomeric component, the article being either porous articles or having the potential to become porous by action of body fluids in situ), the thermoplastic non-elastomeric component being present in such an amount as will provide mechanical strength and rigidity to the article when in an expanded mode.

Abstract: Implantable medical endoprostheses, as well as related systems and methods are disclosed.

Abstract: A stent for reducing the passage of emboli into body lumen once deployed includes a structural portion and a barrier portion. The structural portion, when expanded in a conduit, provides sufficient strength to maintain an open lumen in the conduit. The barrier portion reduces migration of emboli from the wall of the conduit through the structural portion and into the lumen. Stent delivery systems capable of delivering and deploying the stent are disclosed.

Abstract: The invention relates to a radially expandable multi-layer tubular structure which is intended to be used as a stent and to the production method thereof. The inventive structure comprises an outer layer (1) and an inner layer (2) which are solidly connected to one another. One of the aforementioned layers (2) is provided with hollow channels (3) through the thickness thereof while the other layer is provided with perforations (4). Said channels (3) can be used to alter the mechanical properties of the stent and to house a medicament for the local treatment of the vessel in which the stent is disposed.

Abstract: In a process for producing a biocompatible stent, a tubular substrate of the stent adapted for diametric expansion has a layer of a noble metal oxide formed over at least the outer surface of greater diameter of the substrate, the substrate being composed of a metal or an alloy thereof that is non-noble or less-noble than the layer's noble metal. An interface region adapted to prevent corrosion and to provide a firm bond between the surface of the substrate and the noble metal oxide layer is established, at least in part, by forming the noble metal oxide layer with a progressively varying concentration of noble metal-to-oxide with depth of the layer such that a surface of pure noble metal and negligible oxide of the layer is in closest proximity to the surface of the substrate. In one embodiment of the process, the interface region is established by forming the surface of pure noble metal and negligible oxide thereof in direct contact with the metal or alloy of the substrate surface.

Abstract: In an inventive stent (10), helical filaments (12, 13) are disposed on a first tubular layer (11). The helical filaments (12, 13) are mutually phase-shifted such that they do not touch and lie in one plane. The helical filaments (12, 13) are completely coated by a second elastic tubular layer (14) which is connected to the first elastic tubular layer (11). Further helical filaments may be disposed on the second elastic tubular layer (14). The inventive stent can be lengthened for introduction into a hollow organ and is self-expanding.

Abstract: An expandable stent suitable for implantation in a lumen is covered with a biological material. In one embodiment, biological fibers are interwoven to form a stent covering. The fibers are disposed at an angle with respect to the longitudinal axis of the stent so that when the stent is expanded, the angle increases. In another embodiment, a strip of pericardium is helically wound around a supporting stent while the stent is in a compressed state. When the stent is expanded, the strip unwinds, but maintains full coverage of the stent. Interlocking edges may be formed on the strip of pericardium to maintain full coverage of the stent.

Abstract: The present invention comprises a medical device having a support structure made from alternating layers. One or more layers may be made by direct metal laser sintering. One or more layers may be made by introducing nitrogen into a previously formed layer via excimer laser nitriding.

Abstract: A thread for forming a vascular stent implanted in vessels is provided. This thread is formed by melt-spinning a biodegradable polymer. On the surface of the thread, there is formed a layer of a drug-containing biodegradable polymer of the same sort as the biodegradable polymer constituting the thread.

Abstract: A stent is adapted to be implanted in a duct of a human body to maintain an open lumen at the implant site, and to allow viewing body tissue and fluids by magnetic resonance imaging (MRI) energy applied external to the body. The stent constitutes a metal scaffold. An electrical circuit resonant at the resonance frequency of the MRI energy is fabricated integral with the scaffold structure of the stent to promote viewing body properties within the lumen of the stent.

Abstract: A stent having a structure made of a biocorrodible metallic material, having multiple web sections connected to one another, with a support structure made of a number of first web sections connected to one another, designed to assume a function supporting the vascular wall or preserving the mechanical integrity of the stent for a predefinable time after expansion; and at least one second web section electrically connected directly to a first web section of the support structure, which does not assume a function supporting the vascular wall or preserving the mechanical integrity of the stent for the predefined time after the expansion, and whose electrode potential E2 is reduced by a mechanical strain of the second web section during or before the expansion so it is lower than an electrode potential E1 of the first web section after the expansion.

Abstract: A method to quantify the radial endoluminal irregularity of aortoiliac arteries is provided. Radial endoluminal outlines of a vessel of interest are determined. The cross sectional area is determined for the area outlined by each endoluminal outline. Using this cross sectional area a shape is selected that has substantially the same area as the endoluminal outline. Subsequently, the shape is fitted to the endoluminal outline. In one aspect, the irregularity index is calculated as the ratio of the endoluminal outline and the outline of the fitted shape. In another aspect, the irregularity index is calculated as the ratio of at least a part of the endoluminal outline and the outline of the fitted shape that corresponds to the same part of the endoluminal outline. The irregularity index is visualized using a color scheme, a range of numbers, or a set of labels.

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 encased stent that discourages restenosis by having a homogenous endothelial cell lining along the inner wall of the stent. The endothelial cell lining may be coated on the stent before the stent is placed in the artery, or the endothelial cell lining may be grown after placement by several factors that encourage such growth and discourage restenosis. The endothelial cells to coat the stent may be genetically modified to enhance the growth of the endothelial cells into a homogeneous lining. The stent has a continuous lining in the form of a multi-layer polymer coating, including a conducting biocorrosion inhibiting layer and a continuous film of polyurethane coupled by a coupling agent to polyethylene glycol. Various drugs and cell factors may be incorporated into the lining, such as anti-thrombin, anti-inflammatory and anti-coagulant drugs, cell cycle inhibitors, and vascular endothelial growth factors.

Abstract: A polymeric coating for a medical device that comprises poly(lactic acid) and a block copolymer including blocks of poly(ethylene glycol) and poly(butylene terephthalate) is provided.

Abstract: Provided herein is a medical device that includes RGD attached to the device via a spacer compound.

Abstract: The present invention provides multilayered materials, such as films usable in particular in medical devices in the form of vascular grafts, biocompatible coverings, and/or inflatable bladders, prosthesis for the endoluminal treatment of aneurysms, particularly aortic aneurysms including both abdominal aortic aneurysms (AAA's) and thoracic aortic aneurysms (TAA's).

Abstract: A stent is provided with a multi-layer structure, combining one or more mesh layers with one or more film layers. The film layer(s) are configured to substantially prevent growth of an inner lining of a blood vessel, where the stent is placed, through the mesh layer(s). The end-to-end length of the film layer(s) may be greater than the lengths of the mesh layer(s) by at least about 0.5 mm. The mesh and film layers include a radiopaque portion adjacent their ends to provide an X-ray indication of whether the mesh layer(s) have expanded beyond the ends of the film layer(s). If the stent includes inner and outer film layers and a middle mesh layer, the film layers may be sealed together adjacent the ends, encasing and fixing in place the middle layer. The mesh layer may be constructed to be more compliant adjacent its distal end and to expand more rapidly in response to expansion of a balloon catheter as compared to a middle portion of the mesh layer.

Abstract: A multilayer composite vascular access graft and a method of constructing such a graft are disclosed. The mcVAG has improved performance characteristics, which include desirable handling characteristics such as ease of suturing, kink resistance and the ability to serve as a cannulation route soon after the implant procedure.

Abstract: An endoprosthesis, such as a stent, having a layer that can enhance the biocompatibility of the endoprosthesis, and methods of making the endoprosthesis are disclosed.

Abstract: Bioresorbable medical implants are designed to have different resorption rates over time or over the topography of the implants. The resorption of the medical implants are controlled by including layers having differing resorption rates. The layers resorb sequentially over time through sequential exposure to body fluids. A resorption-controllable medical implant includes a series of two or more layers. The first layer includes a first bioresorbable material. The second layer includes a second bioresorbable material and resorbable particles of a first kind dispersed within the second bioresorbable material. Additional layers of bioresorbable material alone or including resorbable particles may be added to slow or speed resorption and achieve desired control over the resorption of the implant. Resorbable particles can be added in differing amounts or kinds in various segments of the implant to provide topographically differing resorption rates.

Abstract: Local drug delivery medical devices are utilized to deliver therapeutic dosages of drugs, agents or compounds directly to the site where needed. The local drug delivery medical devices utilize various materials and coating methodologies to maintain the drugs, agents or compounds on the medical device until delivered and positioned.

Abstract: A suture-less graft coupling system for anastamosis and bypass procedures comprising a first stent for insertion into a radially transected vessel being treated, a graft member overlapping the stented area of the transected vessel, and a second stent overlapping the graft and vessel in an area of the first stent wherein sealing pressure from the second stent can be applied to seal the vessel and graft in a leak-free arrangement.

Abstract: A medical device to protect and/or heal a diseased and/or injured area in the body passageway.

Abstract: An implantable medical device, such as a stent, is disclosed having a coating. The coating includes a poly(butylene terephthalate-co-ethylene glycol)polymer. The coating can also include a drug.

Abstract: An implantable microporous ePTFE tubular vascular graft exhibits long term patency, superior radial tensile strength and suture hole elongation resistance. The graft includes a first ePTFE tube and a second ePTFE tube circumferentially disposed over the first tube. The first ePTFE tube exhibits a porosity sufficient to promote cell endothelization, tissue ingrowth and healing. The second ePTFE tube exhibits enhanced radial strength in excess of the radial tensile strength of the first tube.

Abstract: A vascular prosthesis comprising a first layer having a predetermined first porosity and a second layer having a predetermined second porosity, wherein the first layer and the second layer are each made of first and second electrospun polymer fibers.

Abstract: One aspect of the invention relates to a graft, a surface of which is coated with an amphiphilic block copolymer that includes both hydrophobic and hydrophilic polymer chains. An amphiphilic block copolymer coating according to the invention can serve as a carrier for a very broad range of drugs, possibly including every drug presently used, being considered for use, or likely to be used in the future to inhibit stenosis. The release rates of the drugs can be controlled, for example, through the length of the polymer chains, through their ratio, or through the degree of cross-linking.

Abstract: The present invention relates to implantable medical devices for delivery of therapeutic agents, such as drugs, to a patient. More particularly, the invention relates to a device having therapeutic agents protected by a protective layer that prevents or retards processes that deactivate or degrade the active agents.

Abstract: An expandable medical device has a plurality of elongated struts joined together to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter. At least one of the plurality of struts includes at least one opening extending at least partially through a thickness of the strut. A beneficial agent is loaded into the opening within the strut in layers to achieve desired temporal release kinetics of the agent. Alternatively, the beneficial agent is loaded in a shape which is configured to achieve the desired agent delivery profile. A wide variety of delivery profiles can be achieved including zero order, pulsatile, increasing, decrease, sinusoidal, and other delivery profiles.

Abstract: Coatings are provided in which surfaces may be activated by covalently bonding a silane derivative to the metal surface, covalently bonding a lactone polymer to the silane derivative by in situ ring opening polymerization, and depositing at least one layer of a polyester on the bonded lactone. Biologically active agents may be deposited with the polyester layers. Such coated surfaces may be useful in medical devices, in particular stents.

Abstract: An apparatus (10) for grafting of a blood vessel (12) and a method of forming the apparatus (10) is provided. The apparatus (10) comprises an expandable support member (16) having inner and outer surfaces (36 and 34). The outer surface (34) of the expandable support member (16) is for engaging and adhering to an inside surface (68) of the blood vessel (12). A layer of biological tissue (14) is attached to the inner surface (36) of the support member (16). The layer of biological tissue (14) has an uninterrupted inwardly facing surface (50) for extending confluently with the inside surface (68) of the blood vessel (12) to provide resistance to thrombosis and platelet deposition.

Abstract: The invention is directed to bioengineered graft prostheses made from two or more superimposed, chemically bonded layers of processed tissue material prepared from cleaned tissue material derived from animal sources. The bioengineered graft prostheses of the invention are prepared using methods that preserve cell compatibility, strength, and bioremodelability of the processed tissue matrix. The bioengineered graft prostheses are used for implantation, repair, or for use in a mammalian host.

Abstract: A medical device and system capable of providing on-demand delivery of biologically active material to a body lumen patient, and a method of making such medical device. A first coating layer comprising a biologically active material and optionally a polymeric material is disposed on the surface of the medical device. A second coating layer comprising magnetic particles and a polymeric material is disposed on the first coating layer. The second coating layer, which is substantially free of a biologically active material, protects the biologically active material prior to delivery. The system includes the medical device and a source of energy, such as an electromagnetic or mechanical vibrational energy. When the patient is exposed to the energy source, the magnetic particles move out of the second coating layer and create channels therein through which the biologically active material can be released.

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 flexible covered stent having a stent covered on a first surface by a first layer of biocompatible material and on a second surface by both a second and third layer of biocompatible material, the first and second layers and the first and third layers of biocompatible material being bonded to one another through openings in a wall in the stent. The first layer of biocompatible material is longer than both the second and third layers of biocompatible material such that at least a portion of the second surface of the stent is not covered by either second or third layer, imparting flexibility to the stent.

Abstract: A stent comprising a coating layer is disclosed. The coating layer has a hydrophobic component and a hydrophilic component, wherein a region of the coating layer on or about the outermost surface of the coating layer has a higher content or concentration of the hydrophilic component than the hydrophobic component.

Abstract: A prosthesis, which, when implanted into a mammalian patient, serves as a functioning replacement for a body part, or tissue structure, and will undergo controlled biodegradation occurring concomitantly with bioremodeling by the patients living cells. The prosthesis is treated so that it is rendered non-antigenic so as not to elicit a significant humoral immune response. The prosthesis, in its various embodiments, thus has dual properties. First, it functions as a substitute body part, and second, it functions as bioremodeling template for the ingrowth of host cells.

Abstract: A medical implant made from multiple layers of non-synthetic, natural tissues is provided. The medical device includes openings that extend radially through the wall of the medical implant. One advantage of the medical implant is that a synthetic support structure is not needed. As a result, problems associated with implanting a foreign material into a body may be avoided.

Abstract: A prosthesis, and method for forming same, are provided which includes expanded polytetrafluoroethylene (ePTFE) tubes having angularly offset node and fibril configurations. Also, the node and fibril configurations are angularly offset from the longitudinal axes of the respective tubes, providing resistance against failure in the longitudinal direction.

Abstract: The present invention is an improved endovascular device particularly useful for use in transjugular intrahepatic portosystemic shunt (TIPS) procedures. The device employs a two-part stent-graft construction that provides a low permeability membrane to line the shunt and an uncovered stent portion designed to reside in the portal vein. The device provides numerous benefits over previous stents and stent-grafts used in TIPS procedures, including being more compact to deliver, being easier to accurately deploy, a controlled compacted surface with tucked apices, an improved stent winding pattern, and being more flexible in delivery and use.

Abstract: A flexible self-expandable stent has inside and outside stent bodies each fabricated by knitting first and second super-elastic shape memory alloy wires into a net-like structure with the first wire zigzagged with a diagonal length P interlocked with the second wire zigzagged with a diagonal length 2P at a plurality of interlocked points with intersecting points therebetween to allow the stent bodies to apply force against longitudinal contraction of the stent bodies. The interlocked points and the intersecting points form a plurality of diamond-shaped meshes in the net-like structure of each stent body. A hollow rubber tube is closely fitted between the inside and outside stent bodies, with each of the overlapped ends of the rubber tube and the stent bodies being integrating into a single structure.

Abstract: A vascular prosthesis is constructed from a structure having interconnected, helically oriented channel-porosity to allow oriented ingrowth of connective tissue into a wall of the prosthesis. The prosthesis can have a small internal diameter of 6 mm or less. Several different methods can be used to produce the prosthesis, including a fiber winding and extraction technique, a melt extrusion technique, and a particle and fiber extraction technique using either a layered method or a continuous method. Furthermore, mechanical properties of the prosthesis are matched with mechanical properties of the host vessel, thereby overcoming problems of compliance mismatch.

Abstract: A membrane that reduces the rate at which a therapeutic substance is released from an implantable medical device, such as a stent, is disclosed.