Abstract: An implantable device having a composite weave graft is disclosed. The device comprises a graft body forming a lumen defining a longitudinal axis and comprising proximal and distal ends. The graft body comprises a composite of low dernier yarns and polymeric yarns configured for low profile delivery and radial elongation relative to the longitudinal axis during use. The graft body has a first portion and a second portion extending from the first portion. The first portion comprises at least one expandable stent radially attached thereto for support and the second portion having corrugations for enhanced kink resistance.

Abstract: A stent for use in a medical procedure having opposing sets of curved apices, where the curved section of one set of apices has a radius of curvature that is greater than the curved section of the other set of apices. One or more such stents may be attached to a graft material for use in endovascular treatment of, for example, aneurysm, thoracic dissection, or other body vessel condition.

Abstract: An endoluminal device comprises a stent and a tubular graft supported by the stent. The graft has a proximal and a distal opening and comprises a synthetic material and a bioremodelable material. The bioremodelable material is disposed on an exterior surface in at least one band adjacent at least one of the proximal and distal openings.

Abstract: A method of bonding a first component of a medical device to a second component of the medical device, where at least one of the components comprises a shape memory material, includes positioning the components in close proximity to each other to obtain an assembled configuration, and heating the assembled configuration at a temperature in the range of from about 800° C. to about 1100° C. to obtain a diffusion bond at a region of contact between the two components. The assembled configuration is formed into a desired set shape and heat-set at a temperature in the range of from about 350° C. to about 550° C. to impart a memory of the desired set shape to the shape memory materials without substantially impairing the diffusion bond.

Abstract: A delivery and deployment device comprises a sheath having a proximal end, a distal end, and a lumen disposed therebetween; a dilator having a distal end slidingly disposed within the sheath lumen; a valve assembly comprising a valve housing affixed to the sheath and a valve disposed within the housing between the sheath and the dilator; and a valve lubrication mechanism disposed between the valve and the dilator.

Abstract: The disclosure relates to a method and apparatus for coating a medical device. The method includes providing an electrospinning apparatus and simultaneously electrospinning at least one solution onto a first surface and an opposing second surface. The apparatus comprises a first spinneret and a second spinneret. An energy source is electrically coupled to the first spinneret and the second spinneret. The first spinneret and second spinneret comprise a reservoir and an orifice fluidly coupled to the reservoir. The first spinneret orifice is located substantially opposite the second spinneret orifice.

Abstract: A stent includes a radially expandable tubular structure having a first end, a second end, and a primary strut arrangement extending over substantially an entire length thereof. The primary strut arrangement includes a plurality of rows of struts. The struts are interconnected within each row in a sinusoidal arrangement about a circumference of the tubular structure. Crests and troughs in the sinusoidal arrangement include connection points of the struts. A plurality of longitudinal struts connect neighboring rows of struts at the connection points. In each row, four circumferentially adjacent struts are disposed between every two longitudinal struts joined to the row. One of the two longitudinal struts extends in a direction of the first end to a first neighboring row, and the other of the two longitudinal struts extends in a direction of the second end to a second neighboring row.

Abstract: A motorized delivery system and method for deploying an endoluminal prosthesis is disclosed. The system comprises a delivery device and an electrical drive system. The prosthesis is disposed between an inner dilator and an elongate sheath. To deploy the prosthesis, the electrical drive system is actuated. One or more gear-pulley arrangements rotate to cause retraction of the sheath in relation to the inner dilator.

Abstract: Methods of coating a medical device are provided to improve coating uniformity and reduce coating irregularities while reducing direct coating of the luminal surface of the medical device. Preferably, methods of coating a tubular medical device include the steps of: positioning the tubular medical device around a mandrel coating assembly, mounting the tubular medical device on the mandrel coating assembly and spraying a coating solution including a therapeutic agent and a solvent onto the abluminal surface of the tubular medical device mounted on the mandrel coating assembly. The mandrel coating assembly may include an axial member of a diameter that is less than the diameter of the lumen of the tubular medical device and at least one annular projection extending from the axial member to an outer surface having a diameter greater than or substantially equal to the diameter of the lumen of the medical device.

Abstract: A device for delivering and deploying a prosthesis is described and comprises an elongate sheath having a sheath lumen and a delivery catheter slidably disposed within the sheath lumen. A deployment assist mechanism may be coupled to the delivery catheter and the sheath and configured to apply a retraction force to the delivery catheter and the sheath. Additional devices, systems, and methods of delivering and deploying a prosthesis are described.

Abstract: The present disclosure provides methods of measuring the release of a taxane therapeutic agent from a medical device as a function time in contact with a suitable elution medium. The method preferably comprises the step of contacting a coated medical device comprising a taxane therapeutic agent with an elution medium comprising a cyclodextrin to provide an elution profile indicative of the composition or configuration of a medical device coating comprising a taxane therapeutic agent. The elution profile can provide information about the medical device coating that is useful in lot release testing.

Abstract: Methods of making coated implantable medical devices are provided. The methods include positioning a first layer comprising a bioactive on at least a portion of a structure, and positioning at least one porous layer over the first layer. The at least one porous layer has a thickness adequate to provide a controlled release of the bioactive.

Abstract: A mixing system and method for forming bone cement by mixing liquid monomer methyl methacrylate (MMA) with a powder component comprising polymethyl methacrylate (PMMA). A container of MMA is received in a bag. The MMA is emptied from the container into the bag, and a syringe is connected to the bag in substantially leak-free manner to receive the MMA from the bag. The syringe is disconnected from the bag and thereafter connected to a receptacle housing the powder component. The MMA is then transferred into the receptacle in substantially leak-free manner.

Abstract: A device and method for delivering a bioactive to the uterine wall. In one embodiment, the device comprises a balloon having the bioactive present within the material of the balloon or on an outside surface of the balloon. Another embodiment provides a method comprising inserting the balloon into the uterus, inflating the balloon so that the outside surface of the balloon exerts pressure on uterine wall and delivering the bioactive to the uterine wall.

Abstract: A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer 16 posited on one surface of the structure; and at least one layer 18 of a bioactive material posited on at least a portion of the coating layer 16, wherein the coating layer 16 provides for the controlled release of the bioactive material from the coating layer. In addition, at least one porous layer 20 can be posited over the bioactive material layer 18, wherein the porous layer includes a polymer and provides for the controlled release of the bioactive material therethrough. Preferably, the structure 12 is a coronary stent. The porous layer 20 includes a polymer applied preferably by vapor or plasma deposition and provides for a controlled release of the bioactive material.

Abstract: A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer 16 posited on one surface of the structure; and at least one layer 18 of a bioactive material posited on at least a portion of the coating layer 16, where the coating layer 16 provides for the controlled release of the bioactive material from the coating layer. In addition, at least one porous layer 20 may be posited over the bioactive material layer 18, where the porous layer includes a polymer and provides for the controlled release of the bioactive material therethrough. Preferably, the structure 12 is a coronary stent. The porous layer 20 includes a polymer applied preferably by vapor or plasma deposition and provides for a controlled release of the bioactive material.

Abstract: Medical devices for implantation within a body vessel comprising a graft material and a releasable therapeutic agent are provided. The graft material preferably comprises a biocompatible polyurethane and a therapeutic agent. Preferably, the medical device is a stent graft formed by attaching a polyurethane graft material comprising an elutable taxane therapeutic agent to a radially expandable frame.

Abstract: A coated implantable medical device includes a structure adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer posited on one surface of the structure; and at least one layer of a bioactive material posited on at least a portion of the coating layer. Preferably, the structure is a stent graft.

Abstract: A delivery system for an intraluminal medical device is disclosed. The delivery system comprises an elongate tubular sheath and an elongate tubular pusher. The pusher is slidably disposed within a lumen of the sheath and comprises at least one generally helical score in an exterior surface thereof for providing enhanced flexibility to the pusher.

Abstract: An endovascular delivery device (2) for a stent graft which has a pusher catheter (4), a flexible sheath (10) over the pusher catheter and at least one auxiliary catheter (32) extending between the pusher catheter and the flexible sheath. The pusher catheter has one or more longitudinal grooves (30) on its outside surface and the auxiliary catheter or catheters extend along the longitudinal grooves. A guide wire in the auxiliary catheter can be used to pre-catheterise a fenestration in the stent graft and a branch stent or stent graft delivered through the auxiliary catheter.