Abstract: An implantable device particularly useful for implantation in the common carotid artery at its bifurcation with the internal carotid artery and the external carotid artery for reducing the risk of a stroke, includes a base element for anchoring the device in the artery, and a deflector element for covering the inlet of the internal carotid artery. The deflector element is formed with openings of a size and configuration to deflect emboli in the blood to the external carotid artery without blocking blood flow through the external or internal carotid arteries. The deflector element is attached to a supporting portion of the base element to produce a composite construction. In one described embodiment, the base element is a coil having two opposing ends which overlap to permit expansion for deployment in the artery, and in a second described embodiment the base element is a tube expandable for deployment in the artery.

Abstract: A prosthesis for treating a body passage includes a micro-porous tubular element and a support element. The tubular element is formed from a thin-walled sheet having a wall thickness of 25 micrometers or less, preferably a coiled-sheet exhibiting temperature-activated shape memory properties. The mesh pattern includes a plurality of openings in the sheet having a maximum dimension of not more than about 200 micrometers, thereby acting as a filter trapping embolic material while facilitating endothelial growth therethrough. The support element includes a plurality of struts, preferably having a thickness of 100-150 micrometers. The support element is preferably an independent component from the tubular element. Alternatively, the support element may be attached to or integrally formed as part of the tubular element. The tubular and support elements are placed on a catheter in contracted conditions and advanced endoluminally to a treatment location within a body passage.

Abstract: A vascular prosthesis is constructed from a well-defined pore structure to allow uninterrupted ingrowth of connective tissue into a wall of the prosthesis. Several different methods can be used to produce the prosthesis, including a vacuum impregnation technique, a paste molding technique, a paste extrusion technique, a dip coating technique, and a melt extrusion technique. Furthermore, mechanical properties of the prosthesis are matched with mechanical properties of the host vessel, thereby overcoming problems of compliance mismatch.

Abstract: An implantable device for positioning in the vicinity of the bifurcation of the common carotid artery (CCA) into the internal carotid artery (ICA) and the external carotid artery (ECA) comprises a deflecting element suitable to deflect the flow of embolic material flowing in the CCA toward the ICA, into the ECA.

Abstract: The medical devices of the invention have a portion with a porous surface for release of at least one biologically active agent therefrom. The porous surface is made of a material such as a polymer having a plurality of voids. To load the porous surface with a biologically active agent or drug, an electrophoresis method is employed. In this method, a device having a porous surface is placed into a drug solution or suspension, along with an electrode. An electric current is applied to the device and electrode. Under such a current, the drug, which has a positive or negative charge, will be loaded into the pores or voids of the porous surface.

Abstract: A two-layered fenestrated vascular graft is provided for repair of diseased, damaged or aneurismal blood vessels. The fenestrated vascular graft is configured to be delivered transluminally and implanted within the lumen of a native blood vessel using catheter-based minimally-invasive surgical techniques. The vascular graft is fenestrated or perforated to facilitate making a fluid connection or anastomosis with one or more of the sidebranches of the vessel into which it is implanted. The vascular graft is adapted for implantation into blood vessels, such as the aorta, having tributary vessels or sidebranches along the section of the blood vessel to be repaired without occluding or obscuring the sidebranches. Methods are described for implanting the vascular graft into a patient's aorta for repairing thoracic or abdominal aortic aneurysms and for making a fluid connection or anastomosis with the tributary vessels or sidebranches of the aorta, such as the renal, hepatic and mesenteric arteries.

Abstract: A bioabsorbable implantable endoprosthesis having elongate elements including hollow, cavity or porous portions adapted to accumulate by-product from the degradation of the bioabsorbable material and shortening the diffusion distance for water absorption and thereby relatively increasing the degradation of the structure.

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: A method for forming a kink resistant, blood impermeable graft comprises the steps of: providing a crimped substrate of polymer fabric; coating the outer surface of the substrate with a first solution comprising a first polymer and a particulate in a first solvent; allowing the first solution to dry, thereby forming a first coat on the substrate; coating the first coat with a second solution comprising a second polymer in a second solvent; and immersing the coated substrate in a third solvent to precipitate the second polymer from solution, thereby forming a porous second coat. The third solvent also dissolves the salt in the first coat to form pores in the first coat. The first and second polymer solutions do not penetrate to the interior surface of the substrate of the graft. Vascular prostheses made by this method are blood impermeable and kink resistant and are particularly useful as outflow cannulas for ventricular assist devices.

Abstract: A stenting system for insertion into the lumen of a body duct or vessel for delivering a therapeutic agent to a treatment site on the duct or vessel. The stenting system includes an a tubular stent member having a lumen there through to allow the passage of material, an outer membrane attached to the stent at least a portion of which is porous to the therapeutic agent to allow the agent to pass to the treatment site, an inner membrane attached to the stent which is nonporous to the therapeutic agent to prevent the agent from entering the lumen of the stent, and a chamber located between the inner and outer membranes for holding the therapeutic agent. The therapeutic agent in the chamber may diffuse through the porous portion of the membrane and be deposited directly on the body site.

Abstract: A method for implanting cells onto a prosthesis includes the steps of: (a) providing a prosthesis including a porous tube, where at least 25% of the pores on the inner surface of the tube have diameters of more than about 40 &mgr;m, at least 25% of the pores on the outer surface of the tube have diameters of less than about 30 &mgr;m, and the tube includes a substantially continuous layer of a biocompatible material; (b) contacting the prosthesis with a suspension of cells; and (c) providing a pressure differential between the inner surface and the outer surface, whereby the cells are retained in the pores of the inner surface. A method for obtaining an endothelial cell culture from a blood sample involved:(a) obtaining a sample for mononuclear cells from a blood sample; and (b) culturing the sample of mononuclear cells, without further cell separation, on a cell adhesive polymer-coated solid support in the presence of endothelial growth factors.

Abstract: A prosthesis having an apertured structure is located in a chamber (11) which is taken to sub-atmospheric pressure. Once sub-atmospheric pressure has been reached, a liquid, optionally containing pharmacological agents, is introduced into the chamber. Drawn by the sub-atmospheric pressure, the liquid saturates the apertured structure of the prosthesis. In this way, the invention eliminates the risk of air being trapped in the apertured structure that could give rise to the formation of blood clots after implantation of the prosthesis. The liquid can contain drugs that penetrate the prosthesis, performing their therapeutic action locally and over time after implantation.

Abstract: A method of providing a therapeutic, diagnostic or lubricious hydrophilic coating on an intracorporeal medical device and the coated device produced thereby, wherein the coating is durable. In one embodiment, the coating comprises a polymerized base coat and a top coat having a therapeutic, diagnostic or hydrophilic agent, where the base coat has a binding component which binds to the top coat, and a grafting component which binds to the binding component and adheres to the device. In another embodiment, the coating comprises a blend of an agent, a grafting component, and salt. In one embodiment, the therapeutic agent is superoxide dismutase or a superoxide dismutase mimic. The coating of the invention may be applied to a medical device with a polymeric surface such as a polymeric catheter, or a metal device such as a stent coated with a polymeric primer or without a primer.

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 vascular prosthesis is constructed of an inner porous tube which allows uninterrupted cellular growth and which is connected to an adventitial sock surrounding the porous tube. The adventitial sock produces a non-linear elastic response to stress-strain on the prosthesis to optimize compliance and prevent over dilatation.

Abstract: A vascular graft prosthesis having ingrowth-permissive lumenal wall features with a thin film or layer of sealant-like material placed at a lumenal wall location to promote improved transmural tissue growth and healing.

Abstract: The expandable stent-graft generally defines a cylindrical lumen made from a stent having a discontinuous wail that is at least substantially covered with an expanded polytetrafluoroethylene material. The expanded polytetrafluoroethylene covering may be a biaxially oriented, expanded polytetrafluoroethylene material having nodules and longitudinal and circumferential fibrils or a uniaxially oriented. expanded polytetrafluoroethylene material. The expandable stent-graft expands and compresses in association with the stent structure as it is contracted and expanded.

Abstract: The invention relates to a process for producing an implant, with the implant possessing a textured foreign structure. A porous protein matrix is at least partially anchored in the textured foreign structure, with the porous protein matrix possessing a directional pore structure.

Abstract: A composite intraluminal prosthesis which is preferably used as a vascular prothesis includes a layer of ePTFE and a layer of textile material which are secured together by an elastomeric bonding agent. The ePTFE layer includes a porous microstructure defined by nodes interconnected by fibrils. The adhesive bonding agent is preferably applied in solution so that the bonding agent enters the pores of the microstructure of the ePTFE. This helps secure the textile layer to the ePTFE layer.

Abstract: The present invention provides methods of coating an implantable device, such as a stent or a graft, having a plurality of depots formed in a surface thereof. An exemplary method includes applying a composition including a polymer and a solvent to the implantable device proximate to the depots. Such application of the composition is performed at a first gas pressure. The method also includes applying a second gas pressure, which is greater than the first gas pressure, to the composition-coated device so that air pockets in the depots are eliminated, or at least reduced in size. The method also includes the act of removing the solvent from the composition to form a coating. An implantable device coated in accordance with the method is also provided.

Abstract: A stent-graft assembly having a thin-walled membrane and method of preparing the same are disclosed. In a first embodiment, the assembly comprises a stent, a coating and a porous membrane, wherein the membrane is less than 0.040 inch thick or less. Portions of the coating extend into the pores of the thin membrane to sealingly engage the membrane to achieve secure adhesion. In a second embodiment the coating and thin membrane bond to form a homogenous structure. In an alternative embodiment, the assembly comprises an inner and outer thin membrane bound to one another through the interstices of the support member and a coating at the proximal and distal regions. In any of the foregoing embodiments, the proximal and distal regions of the stent-graft assembly may comprise an additional coating, whereby layers of material are sealed, thereby minimizing thrombogenic potential of free ends of the assembly.

Abstract: In accordance with the present invention there is provided an improved stent graft for insertion into a body vessel of a patient. The stent graft includes a hollow substantially cylindrical stent comprising a plurality of interconnected struts. In addition, the stent graft includes a graft material attached to the stent, wherein the graft material is an open cell foam material having a multiplicity of cells having an average diameter ranging from about 100-500 micrometers, and a cell density on a surface thereof ranging from about 50-100 cells per inch.

Abstract: A multilayer ingrowth matrix is constructed within well-defined porosity of a prosthetic material. The matrix consists of either proteinaceous or synthetic layers or gradients, or a combination of proteinaceous and synthetic layers or gradients. Each layer within the matrix is designed to achieve a specific function, such as facilitation of ingrowth of a particular cell type or release of a particular growth factor. The well-defined porosity is in the form of either helically oriented, interconnected transmural ingrowth channels, or a porous wall structure containing uniformly shaped pores (i.e. voids) in a very narrow size range, or a combination of channels and pores. This invention allows for uninterrupted ingrowth of connective tissue into walls of a synthetic graft prosthesis made from the prosthetic material. Furthermore, this invention can produce small diameter prostheses having an internal diameter of 6 mm or less.

Abstract: A stent substantially completely encapsulated with a microporous polymeric membrane is provided. Encapsulation of the stent may be accomplished by an electrostatic deposition process. The microporous polymeric membrane may contain variable concentrations of one or more pharmacotherapeutic agents. After deployment to a site of interest, the stent and more specifically, the membrane, provides local delivery of sustained or controlled therapeutic dose of one or more of suitable pharmacotherapeutic agent.

Abstract: An implantable prosthesis includes a porous polymeric member having pores present in its wall structure wherein these pores contain a variety of therapeutically useful compositions including, collagen, genetically altered cells and piezoelectric materials. A process of preparing such a prosthesis is also disclosed.

Abstract: A prosthetic vascular graft with walls less than O.8B millimeters in thickness and formed of highly expanded polytetrafluoroethylene with a microscopic superstructure of nodes and interconnecting fibrils, which nodes are substantially uniformly separated by an average distance greater than a typical red cell. The superstructure of the graft controls transmural cellular ingrowth and assures the establishment and maintenance of a thin,viable neointima.

Abstract: Non-expanded porous PTFE materials and products are disclosed. More particularly, grafts and stent-grafts incorporating the non-porous PTFE materials are described.

Abstract: Medical devices and systems for the localized delivery of genetic information to a target location within a mammalian body. In one embodiment, the system comprises a medical device insertable into the body and a biostable coating over at least part of the medical device. Genetic information is incorporated into the biostable coating before the medical device is placed into the body, and is released from the biostable coating at a target location within the body. The invention also includes methods for the localized delivery of genetic information to target locations within a mammalian body using the medical devices and systems of the invention.

Abstract: A prosthesis for treating a body passage includes a micro-porous tubular element and a support element. The tubular element is formed from a thin-walled sheet having a wall thickness of 25 micrometers or less, preferably a coiled-sheet exhibiting temperature-activated shape memory properties. The mesh pattern includes a plurality of openings in the sheet having a maximum dimension of not more than about 200 micrometers, thereby acting as a filter trapping embolic material while facilitating endothelial growth therethrough. The support element includes a plurality of struts, preferably having a thickness of 100-150 micrometers. The support element is preferably an independent component from the tubular element. Alternatively, the support element may be attached to or integrally formed as part of the tubular element. The tubular and support elements are placed on a catheter in contracted conditions and advanced endoluminally to a treatment location within a body passage.

Abstract: A graft compatible with living animal tissue is disclosed. The graft has attachment regions with means for promoting growth of living animal tissue across the attachment regions to form a biological seal between the graft and the tissue. The means for promoting growth include locating pores in the attachment regions sized to favor growth of the tissue, increasing the surface area of the attachment regions by forming filamentary loops extending from the attachment regions, forming the attachment regions from textured filaments, forming the attachment regions from materials which elicit a healing reaction in living animal tissue or coating the attachment regions with a compound such as thrombin or collagen which promotes healing of the tissue.

Abstract: The present invention relates to a support structure/membrane composite device which includes a support structure, such as a radially expandable stent, a porous non-textile polymeric membrane adjacent to said stent and a thermoplastic anchor means attaching said stent to said porous non-textile polymeric membrane. The porous non-textile polymeric membrane is preferably made from expandable fluoropolymer materials. The anchoring means is a thermoplastic material which is dissolvable at the interface between the support structure and membrane by a suitable solvent which wets the membrane surface and deposits the thermoplastic material within the pores of the membrane. Methods of preparing the device are also disclosed.

Abstract: Shape memory alloy and elastically self-expanding endoluminal stents which are at least partially encapsulated in a substantially monolithic expanded polytetrafluorethylene (“ePTFE”) covering. An endoluminal stent, which has a reduced diametric dimension for endoluminal delivery and a larger in vivo final diametric diameter is encapsulated in an ePTFE covering which circumferentially covers both the luminal and abluminal walls along at least a portion of the longitudinal extent of the endoluminal stent. The shape memory endoluminal stent is fabricated from a shape memory alloy which exhibits either shape memory or pseudoelastic properties or from an elastic material having an inherent spring tension.

Abstract: An expandable stent includes a tubular structure with an outer surface positionable adjacent to a vessel wall and an inner surface facing a lumen of a body passageway. The tubular structure further includes a plurality of expansion struts, connector struts and cells. The tubular structure has a first diameter which permits intraluminal delivery of the tubular structure into the body passageway, and a second expanded and deformed diameter which is achieved upon the application of a radially, outwardly extending force. A plurality of cavities are formed in the outer surface of the stent.

Abstract: An endovascular support device adapted for local delivery of a therapeutic agent and for minimizing the rate of restinosis having a cylindrical support body with an inside surface and an opposite outside surface, and at least one layer of pericardial tissue covering at least a portion of at least a selected one of the inside surface or the outside surface of the cylindrical support body. At least one therapeutic agent is disposed on a portion of the support device.

Abstract: Disclosed herein is a method for implanting cells onto a prosthesis, including the steps of: (a) providing a prosthesis including a porous tube, where at least 25% of the pores on the inner surface of the tube have diameters of more than about 40 &mgr;m, at least 25% of the pores on the outer surface of the tube have diameters of less than about 30 &mgr;m, and the tube includes a substantially continuous layer of a biocompatible material; (b) contacting the prosthesis with a suspension of cells; and (c) providing a pressure differential between the inner surface and the outer surface, whereby the cells are retained in the pores of the inner surface. Also disclosed herein are methods for culturing cells for implantation.

Abstract: An improved prosthetic graft for the bypass, replacement or repair of vessels and organs that are in contact with blood flow is disclosed. The prosthetic graft includes a porous prosthetic implant and adherent cells adhered to the outer surface of the implant. The adherent cells are transfected with at least one recombinant nucleic acid molecule encoding at least one protein that enhances patency of the graft. The prosthetic graft has a long-term patency and success rate that is superior to other previously described prosthetic grafts designed for such use. Also disclosed are methods of making and using such a graft.

Abstract: A prosthesis for treating a body passage includes a micro-porous tubular element and a support element. The tubular element is formed from a thin-walled sheet having a wall thickness of 25 micrometers or less, preferably a coiled-sheet exhibiting temperature-activated shape memory properties. The mesh pattern includes a plurality of openings in the sheet having a maximum dimension of not more than about 200 micrometers, thereby acting as a filter trapping embolic material while facilitating endothelial growth therethrough. The support element includes a plurality of struts, preferably having a thickness of 100-150 micrometers. The support element is preferably an independent component from the tubular element. Alternatively, the support element may be attached to or integrally formed as part of the tubular element. The tubular and support elements are placed on a catheter in contracted conditions and advanced endoluminally to a treatment location within a body passage.

Abstract: An endoprosthesis is provided having an expandable, generally cylindrical body portion defining an inside surface and an outside surface. The inside surface is preferably regular and smooth to yield a low coefficient of friction, while the outside surface is modified to yield a relatively high coefficient of friction with a vessel surface, includes a macroscopic surface modification to engage the vessel surface, or includes an adhesive coating that bonds the stent to the vessel surface.

Abstract: A porous tube suitable for use as a vascular graft prosthesis and a method of making it is disclosed. It has a structure of porous polytetrafluoroethylene having a fibrous structure of nodes and fibers connecting the nodes together and an integrated intrawall circumferential support adjacent to areas of variable porosity. This invention provides a polytetrafluoroethylene polymer in a porous form useful as artificial internal organs for, for example vascular bypass, vascular access, and endovascular prosthesis. PTFE walls are found with radial zones of differing porosity are described.

Abstract: Medical devices including a substrate that are expandable from a compressed state to an expanded state; a coating on the substrate, the coating having a drug agent incorporated therein; and a sheath over the coating. The sheath is expandable from a compressed state to an expanded state and has at least one perforation therein. The medical devices are configured such that when the substrate is in a compressed state, the sheath is also in a compressed state and the perforation is substantially closed. When the substrate is in an expanded state, the sheath is also in an expanded state and the perforation is substantially open. The invention also includes a method of using the medical devices for the controlled, localized delivery of a drug agent to a target location within a mammalian body.

Abstract: Delivery of rapamycin locally, particularly from an intravascular stent, directly from micropores in the stent body or mixed or bound to a polymer coating applied on stent, to inhibit neointimal tissue proliferation and thereby prevent restenosis. This invention also facilitates the performance of the stent in inhibiting restenosis.

Abstract: Disclosed is a radioactive tubular prosthesis formed by rolling a flexible sheet around a longitudinal axis. Preferably, the prosthesis is self expandable under the radially outwardly directed spring bias of the rolled sheet. At least a portion of the sheet is provided with a coating comprising at least one radioisotope.

Abstract: The present invention is directed to devices and methods for diverting emboli away from the carotid arteries in the aorta. The devices are aortic diverters that generally comprise a hollow tube with a substantially cylindrical or conical wall, which is impermeable to emboli and which has open ends that allow blood to enter one end, flow through the tube and exit the other end. Additionally, snowshoe aortic diverters, which are planar rather than cylindrical are also disclosed. The methods of the invention generally include the steps of providing an aortic diverter carried by an intravascular catheter, introducing the intravascular catheter into the vascular system, advancing the intravascular catheter into the aortic arch to the region of the carotid arteries, and deploying the aortic diverter.

Abstract: A method of manufacturing a medicated prosthesis such as a stent. The method includes forming a stent out of porous metal and loading a therapeutic agent into the pores of the metal. In one embodiment the stent is formed from a sintered metal wire, sheet, or tube and can include adding a coating to the stent. When the stent is implanted into the vasculature of a patient, the therapeutic agent in the stent dissipates into the tissue of the vasculature proximate the stent.

Abstract: A vascular prosthesis is constructed from a well-defined pore structure to allow uninterrupted ingrowth of connective tissue into a wall of the prosthesis. Several different methods can be used to produce the prosthesis, including a vacuum impregnation technique, a paste molding technique, a paste extrusion technique, a dip coating technique, and a melt extrusion technique. Furthermore, mechanical properties of the prosthesis are matched with mechanical properties of the host vessel, thereby overcoming problems of compliance mismatch.

Abstract: An implantable prosthesis includes a porous polymeric member having pores present in its wall structure wherein these pores contain a variety of therapeutically useful compositions including, collagen, genetically altered cells and piezoelectric materials. A process of preparing such a prosthesis is also disclosed.

Abstract: Solid free-form fabrication (SFF) methods are used to manufacture devices for allowing tissue regeneration and for seeding and implanting cells to form organ and structural components, which can additionally provide controlled release of bioactive agents, wherein the matrix is characterized by a network of lumens functionally equivalent to the naturally occurring vasculature of the tissue formed by the implanted cells, and which can be lined with endothelial cells and coupled to blood vessels at the time of implantation to form a vascular network throughout the matrix. The SFF methods can be adapted for use with a variety of polymeric, inorganic and composite materials to create structures with defined compositions, strengths, and densities, using computer aided design (CAD). Examples of SFF methods include stereo-lithography (SLA), selective laser sintering (SLS), ballistic particle manufacturing (BPM), fusion deposition modeling (FDM), and three dimensional printing (3DP).