Abstract: A vascular graft for treatment of diseased or damaged blood vessels is disclosed. The graft comprises a sheet of acellular tissue matrix with an intact basement membrane. The graft is formed by wrapping the sheet into a tube and securing the edges of the sheet together. The acellular tissue matrix facilitates tissue ingrowth and remodeling of the graft with host cells.

Abstract: This invention is directed to a coating for a medical device, such as an intravascular stent, in which the coating, which comprises a first coating region comprising an adhesion promoter and a therapeutic agent. The coating can also include a second coating region which is substantially free of the adhesion promoter or any adhesion promoter. The invention is also directed to a method for manufacturing such a coated medical device.

Abstract: A block copolymer comprising a fluorinated block and a non-fluorinated block and method of making the block copolymer are provided. Also provided herein are a coating on an implantable device comprising the block copolymer and method of using the implantable device.

Abstract: A composite vascular graft is provided, which incorporates bioactive agents that can be controllably delivered to the implantation site to deliver therapeutic materials and/or to reduce infection of the implant. The vascular graft of the present invention includes a luminal layer of ePTFE; and a biodegradable polymer layer including a bioactive agent, such as an antimicrobial agent. The biodegradable polymer layer is posited on the external surface of the luminal ePTFE layer. The graft also includes a fabric layer, which is posited on the external surface of the biodegradable layer. The graft is particularly useful as an arterial-venous graft for hemodialysis procedures.

Abstract: One example embodiment of the present invention relates to an implant, particularly an intraluminal endoprosthesis, having a body that contains metallic material, preferably iron. The implant body has a first layer with at least one ionic compound that contains ions of at least one halogen, particularly chloride ions and/or bromide ions, on at least part of its surface. Furthermore, a method for the production of such an implant is described.

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, decreasing, sinusoidal, and other delivery profiles.

Abstract: A crack-resistant endoprosthesis for delivery in a body lumen can be comprised of a multilayered material. The multilayered material can include at least two layers having a boundary layer therebetween. The boundary layer is configured to inhibit cracks from propagating from a first layer-to a second layer. The different layers can be comprised of the same materials or different materials. It can be preferred that the multilayered material have layers that are comprised of resiliently-flexible materials, shape memory materials, and/or radiopaque materials.

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: This invention relates to medical devices and an angiotensin II type 2 (AT2) receptor antagonist compound, the medical device being adapted to release the AT2 receptor antagonist compound within a body of a patient. This invention also relates to medical devices and methods of treatment of disease, such as aneurysms and aortic dissection. Medical devices may include coated stents, grafts, stent grafts, balloons and catheters.

Abstract: Coatings for stents that include a polymer and a drug are provided. A method of forming the coatings is also provided.

Abstract: A wavily deformable stent includes a hollow cylindrical net body formed of elastically deformable wires interlaced with each other. The net body extends in a longitudinal direction and terminates at open opposite ends. The net body has at least one high-rigidity section and at least one low-rigidity section less rigid than the high-rigidity section. The high-rigidity section and the low-rigidity section are arranged continuously and alternately along the longitudinal direction. The stent is wavily deformed and held in place against unwanted displacement when situated inside a stenosed part of a bodily organ. Also provided is a method for producing the wavily deformable stent.

Abstract: A balloon expandable covered stent consists of a plurality of primary stent units, each having an undulating shape defined by a series of primary strut members converging to form peaks and valleys. The primary stent units are assembled into a single cylindrical structure of the stent by connecting corresponding peaks with secondary strut members. Generally, surfaces of the stent may then coated with a polymeric, hyper-elastic material, preferably Thoralon®, by pre-expanding the stent prior to coating.

Abstract: A stent includes a main body of a generally tubular shape for insertion into a lumen of a vessel of a living being. The tubular main body includes a substantially biodegradable matrix having collagen IV and laminin that enclose voids within the matrix. The tubular main body also includes a biodegradable strengthening material in contact with the matrix to strengthen the matrix. The tubular main body is essentially saturated with drugs.

Abstract: A graft, for example, an arterio-venous shunt graft, is provided, which in a first aspect of the subject invention, is formed with longitudinal ribs. With fibrotic tissue ingrowth between the ribs, a composite rib/tissue layer is formed about the graft. The ribs provide counteracting lateral force against the embedded tissue to seal punctures formed therethrough during hemodialysis procedures. To provide additional surface area for puncturing, the graft may be formed with a truncated cross-section. With a second aspect of the invention, the graft is mounted onto a strip to prevent kinking, twisting or bending during an implantation procedure.

Abstract: An intraluminal device with controlled biodegradation is provided. The intraluminal device comprises a biodegradable tubular main body. An outer photodegradable layer is disposed over at least a portion of the intraluminal device. The photodegradable outer layer is chemically inert to the body fluids of the implanted region, thereby preventing premature biodegradation of the stent. Degradation of the outer photodegradable layer after a predetermined time occurs by irradiating the layer with UV light waves. After removal of the outer photodegradable layer, the tubular main body becomes exposed to its in vivo environment, thereby allowing biodegradation of the tubular main body.

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: 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: 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 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 method of making a tubular intraluminal graft in the form of a tubular diametrically adjustable stent having a tubular covering of porous expanded polytetrafluoroethylene which is less than 0.10 mm thick. The covering may be on the exterior surface of the stent, or on the interior surface of the stent, or both. The covering may be affixed to the stent by an adhesive which is preferably fluorinated ethylene propylene.

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: There is described an artificial blood vessel for use in a region of a living body which needs to be repeatedly pierced with a needle. The artificial blood vessel includes a main section having a vessel wall which includes a laminated assembly comprising an inner layer, an outer layer, and an intermediate layer positioned therebetween, and a pair of anastomotic sections disposed on the respective opposite ends of the main section. Each of the anastomotic sections has an intermediate layer thinner than the intermediate layer of the main section or is free of an intermediate layer, so that the anastomotic section as a vessel wall thinner than the main section.

Abstract: Medical devices, such as endoprostheses, and methods of making the devices are disclosed. The medical device can include a composite cover formed of a deposited metallic film and one or more polymer layers. The polymer layers contribute to mechanical or biological properties of the endoprosthesis.

Abstract: This invention relates to stents having medicated multi-layer hybrid polymer coatings, useful for the treatment of stenosed vasculature or other body passages.

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 self-sealing vascular graft with kink resistance is described. The vascular graft includes a substrate that can be a PTFE, having a self-sealing region that may include several layers of material. The central section of the vascular graft may be constructed differently from surrounding self-sealing regions, in order to provide kink resistance following the clamping of the graft. Also described is a graft with a flared cuff attached to one or both ends, the attachment or transition region including reinforcement beading.

Abstract: An implant having a coating comprising a polymer matrix is swollen in a pharmaceutical solution whereby pharmaceutically active compound is imbibed into the polymer matrix. When the product is implanted, release of the pharmaceutically active compound from the coating takes place. The polymer is preferably formed from ethylenically unsaturated monomers including a zwitterionic monomer, most preferably 2-methacryloyloxyethyl-2?-trimethylammoniumethyl-phosphate inner salt. The monomers from which the polymer is formed may further include surface binding monomers, such as hydrophobic group containing monomers, and crosslinkable monomers, the content of which may be used to control the swellability. Preferably the implant is a stent and the coating of polymer on the exterior wall surface is thicker than the coating of polymer on the interior surface. Release of the drug may be controlled by selection of comonomers. The implant is suitably a stent for use in the cardiovascular system.

Abstract: Provided herein is a PEA polymer blend and coatings or implantable devices formed therefrom.

Abstract: A radio frequency antenna is provided for use with a medical device for implantation into an animal. The antenna comprises a coil formed by a wire that includes a core formed of a shape-memory material with an electrically conductive first layer applied to an outer surface of the core. A second layer, of an electrically insulating and biologically compatible material, extends around the first layer. If necessary to reduce friction a lubricant is place between the first and second layers. If second layer is formed of porous material or a non-biological compatible material, a biological compatible outer layer surrounds the second layer thereby providing a barrier that is impermeable to body fluids of the animal.

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 method of making an tubular intraluminal graft in the form of a tubular diametrically adjustable stent having a tubular covering of porous expanded polytetrafluoroethylene which is less than 0.10 mm thick. The covering may be on the exterior surface of the stent, or on the interior surface of the stent, or both. The covering may be affixed to the stent by an adhesive which is preferably fluorinated ethylene propylene.

Abstract: A modular elongated stent having an overlap region where two modular components fit together, the overlap region being relatively stiff as compared to another more flexible region of the stent when the stent is in an assembled configuration, the stent further comprising a mimic region that has a stiffness essentially equivalent to the stiffness of the overlap region, to provide kink resistance. A stent having such a mimic region or otherwise stiff region and a flexible region may have a transition region between the stiff and flexible regions, also to provide kink resistance. A stent may have relatively stiff regions and relatively flexible regions positioned to align the flexible regions with curved regions of a body lumen when deployed within the body lumen. The stiffness of the stiff, flexible, and transition regions may be controlled by varying the cross-sectional area of the stent components and/or by varying the stent architecture.

Abstract: Ureteral stents having at least a portion of a proximal end of the ureteral stent constructed with a material that dissolves after being exposed to a bodily fluid for a period of time are disclosed herein. At least a portion of the proximal end portion of the elongate member includes a dissolving portion configured to dissolve in response to being exposed to a bodily fluid for a period of time. The elongate member also includes a non-dissolving portion that includes the entire retention member of the distal end portion and is substantially stable in the bodily fluid of the urinary tract of the patient. In some embodiments, a medial portion of the ureteral stent is also constructed with one or more dissolving materials. In some implementations, the proximal and/or the medial portions of the ureteral stent are constructed using various combinations of dissolving and non-dissolving materials.

Abstract: A method of creating a porous carbon coating on a medical device by applying a precursor carbon material on the medical device and then pyrolysing the precursor carbon material by laser irradiation. The laser irradiation may be focused to carbonize only certain portions of the medical device and any uncarbonized areas can be removed by solvent washing. Also provided is a medical device having a carbonized coating created according to the method of the present invention.

Abstract: A stent includes a body, a layer of therapeutic agent over at least a section of the body, and a sealant layer over the layer of therapeutic agent. The sealant layer includes a through hole that allows release of the therapeutic agent of the therapeutic agent layer through the through hole when the stent is deployed in a blood vessel.

Abstract: A porous prosthesis for delivering a medication to the site of implantation, and a method of making the same, is disclosed.

Abstract: A endoprosthesis includes a body comprising a plurality of interconnected struts. The body includes a bioerodible metal. At least a first strut of the plurality of interconnected struts includes a stripe on the surface of the first strut. The stripe including a nitride of the bioerodible metal, a fluoride of the bioerodible metal, or a combination thereof. The stripe runs along the length of the first strut. The stripe is part of a continuous network of stripes on struts adjacent to the first strut.

Abstract: The present invention proposes a method for manufacturing an implant, in particular an intraluminal endoprosthesis, having a body such that the body has metallic material. To control the degradation in a desired time window, e.g., between four weeks and six months, the following production method is performed: a) preparing the body of the implant, and b) plasma-chemical treatment of at least a portion of the surface of the body in an aqueous solution by applying a plasma-generating electric alternating voltage to the body (5) of the implant, said voltage having a frequency of at least approximately 1 kHz, to create a first layer. The invention also relates to an implant obtainable by such a method.

Abstract: A stent is formed by encasing or encapsulating metallic rings in an inner polymeric layer and an outer polymeric layer. At least one polymer link connects adjacent metallic rings. The stent is drug loaded with one or more therapeutic agent or drug, for example, to reduce the likelihood of the development of restenosis in the coronary arteries. The inner and outer polymeric materials can be of the same polymer or different polymer to achieve different results, such as enhancing flexibility and providing a stent that is visible under MRI, computer tomography and x-ray fluoroscopy.

Abstract: A method is provided for forming a polymeric coating on a stent. The method can comprise applying a prepolymer or a combination of prepolymers to the stent and initiating polymerization to form a polymeric coating on the stent. The coating material can optionally contain a biologically active agent or combination of agents.

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: A stent is provided which has a relatively less porous support structure that includes a first set of consolidated particles and at least one relatively more porous reservoir that includes a second set of consolidated particles that differ in composition from the first set of consolidated particles.

Abstract: Embodiments of the present invention provide medical devices and methods for treating a target site within the body. For example, one embodiment provides a stent graft for treating a target site proximate to a bifurcated lumen, wherein the stent graft includes a first tubular structure having proximal and distal ends and a side wall extending therebetween. The first tubular structure includes an opening defined within the side wall and is configured to define a first portion having first and second ends and a second portion having first and second ends. The opening corresponds to the first ends of the first and second portions and the second ends of the first and second portions respectively correspond to the proximal and distal ends of the first tubular structure, and at least a portion of the first and second portions are configured to be positioned within respective branches of a bifurcated lumen.

Abstract: Endoprosthesis assemblies and methods of making endoprosthesis assemblies are disclosed. For example, endoprosthesis assemblies are described that include an endoprosthesis body and a polymeric coating about the endoprosthesis body. The polymeric coatings are engaged tightly to the endoprosthesis wall through engageable features created on the surface of the polymeric coatings and the surface of the endoprosthesis wall prior to engaging the surfaces.

Abstract: A biocompatible, bioerodable polyanhydride polymer having a Young's modulus between about 1.5 and 3 and a selected rate of surface degradation, and methods of forming and using the polymer, are disclosed. The polymer is formed of a polyester prepolymer having a preferred molecular weight of greater than 5 and less than 7.5 Kdaltons, and a selected number of anhydride linkages between 5 and about 30.

Abstract: Endoprostheses include an endoprosthesis wall that includes a surface layer that includes a metallic material and that defines a plurality of pores. A therapeutic agent fills one or more pores of the surface layer and a non-polymeric coating, covers the therapeutic agent in the one or more pores. The endoprostheses can, for example, deliver a therapeutic agent, such as a drug, in a controlled manner over an extended period of time.

Abstract: Composite stent structures having multi-axial flexibility are described where the composite stent may have one or more layers of bioabsorbable polymers fabricated with the desired characteristics for implantation within a vessel. A number of individual ring structures separated from one another may be encased between a base polymeric layer and an overlaid polymeric layer such that the rings are coupled to one another via elastomeric segments which enable the composite stent to flex axially and rotationally along with the vessel. Each layer may have a characteristic that individually provides a certain aspect of mechanical behavior to the composite stent such that the aggregate layers form a composite polymeric stent structure capable of withstanding complex, multi-axial loading conditions imparted by an anatomical environment such as the SFA.

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: A bioresorbable endoluminal prosthesis for placement in a body lumen having a stent substrate of a first metallic material that has a lower electrical potential than a standard reference electrode. The stent substrate is coated with a biodegradable polymer having a second metallic material dispersed therein, wherein the second metallic material has a higher electrical potential than the standard reference electrode. After implantation of the stent within the body lumen, the second metallic material is present in the polymeric coating in a sufficient concentration to cause galvanic corrosion of the first metallic material such that over time the stent substrate is bioresorbed.

Abstract: Methods of coating a stent subsequent to mounting or crimping of the stent on a balloon of a catheter assembly are disclosed. One method includes forming a sacrificial layer on a balloon of a catheter assembly; followed by mounting a stent on the balloon, the stent including struts separated by gaps; followed by forming a stent coating on the stent; and followed by removal of the sacrificial layer. Another method includes mounting a stent on a balloon, the stent including struts separated by gaps; followed by forming a sacrificial layer on the balloon in the areas of the gaps between struts of the stent; followed by forming a coating on the stent; and followed by removing the sacrificial layer, wherein the coating remains on an outer surface of the stent.