Abstract: An implantable medical device, such as a stent or graft, having asperities on a designated region of its outer surface is disclosed. The asperities can serve to improve retention of one or more layers of a coating on the device and to increase the amount of coating that can be carried by the device. The asperities can be formed by using a stream of pressurized grit to roughen the surface. The asperities can also be formed by removing material from the outer surface, for example, by chemical etching with or without a patterned mask. Alternatively, the asperities can be formed by adding material to the outer surface, for example, by welding powder particles to the outer surface or sputtering.

Abstract: A mitral valve therapy device effects the condition of a mitral valve annulus of a heart. The device includes an elongated member dimensioned to be placed in the coronary sinus of the heart adjacent the mitral valve annulus. The elongated member is flexible when placed in the heart in a first orientation to position the device in the coronary sinus adjacent the mitral valve annulus and relatively inflexible when rotated into a second orientation after the device is positioned in the coronary sinus adjacent to the mitral valve annulus to substantially straighten and increase the radius of curvature of the mitral valve annulus.

Abstract: A blood vessel wall-defining device for repairing an abdominal aneurysm includes a percutaneously-insertable structural frame extending between first and second ends having an unexpanded diameter which is smaller than the diameter of the blood vessel to permit the structural frame to be placed into the blood vessel. The structural frame is expansible to form a cylindrical structural skeleton having a slightly larger diameter than the blood vessel to facilitate the securing of the skeleton in position in the blood vessel. The skeleton has a sheath of a tubular fabric. The structural frame has a plurality of spaced coiled stents prior to expansion which are uncoiled under the aegis of a balloon catheter and locked into position by ratchet means.

Abstract: Apparatus for reducing mitral regurgitation, including a bendable elongated body adapted to be inserted into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the elongated body being adjustable between a first configuration adapted to be delivered into the coronary sinus and a second configuration adapted to exert a force onto the posterior annulus. The body includes a flexible spine having a proximal end and a distal end, and a flexible wire mounted on the spine and having a distal end fixed to the spine proximate to the distal end of the spine, and having a proximal portion extending from the proximal end of the spine. Axial movement of the wire causes a change in the spine from the first configuration to the second configuration to exert the force on the posterior annulus and thereby reduce mitral regurgitation.

Abstract: An intraocular lens for use in a mammalian eye having a natural lens, the intraocular lens including a lens body sized and adapted for placement in the eye, and having a baseline optical power and at least one optical add power. The at least one optical add power is reduced relative to the corresponding optical power of a similar intraocular lens adapted for placement in a similar eye in which the natural lens has been removed.

Abstract: A process for removing contaminants and/or leachables from polymeric materials useful in the manufacture of biocompatible medical devices such as intraocular lenses, corneal inlays and contact lenses using continuous soxhlet extraction.

Abstract: An interbody device for use between a pair of adjacent vertebrae includes a body and at least one expansion member. The body has upper and lower walls that are joined by a rear wall that functions as a spring hinge. The walls have anterior ends that are supported in a non-expanded configuration by spaced feet that project out from the walls. The expansion member is elongate and has a threaded portion that is threadably received in the rear wall. Each expansion member also includes a head having a wedge portion that engages the anterior ends of the walls and forces the walls apart as the expansion member is screwed into the body. Preferably, the expansion member is only one of a plurality of expansion members found in a kit which vary with respect to the diameter of the expansion member head. Further, a support and connecting plate is preferably utilized subsequent to installation of the devices between vertebrae to connect the connected pair of the devices.

Abstract: A medical, bioresorbable implant, particularly for cruciate ligament augmentation, is constructed as a composite structure in textile construction from at least two biocompatible polymer materials, which differ in their chemical composition and/or polymer structure and which are degradable, the implant having a predetermined initial tensile stiffness and a different degradation behaviour of the polymers and/or the textile construction is selected in such a way that the tensile stiffness decreases during degradation.

Abstract: An implantable textile prosthesis which is anatomically curved to substantially match the natural curvature of the aortic arch in a human being or patient is provided. The first woven section is arched define an apical region and to conform generally to an aortic arch of a human patient. A plurality of elongate woven tubular extents extend vertically from a top wall portion at the apical region of the tubular main wall. These tubular extents are sutured to the first woven section to provide fluid communication between the tubular main wall and the tubular extents.

Abstract: A method for deploying an aortic valve prosthesis includes the steps of: making a first opening leading to the left atrium; passing the valve prosthesis through the opening and into a cardiac chamber of the left side of the heart using a first manipulation instrument; making a second opening in the arterial system and advancing one end of a second manipulation instrument through the arterial opening and into the cardiac chamber; securing the second manipulation instrument to the valve prosthesis; and using the second manipulation instrument to retract at least a portion of the valve prosthesis out of the cardiac chamber.

Abstract: The present design envisions a flexible connecting link used in conjunction with in-phase and half-phase circumferential sets of strut members. By increasing the total length and diagonality of the undulating connecting links, the present design is a stent that provides increased flexibility during delivery and enhanced conformability to the shape of a curved artery when the stent is deployed into a curved vessel such as a tortuous coronary artery. Also, unique balloon-stent interactions are described.

Abstract: A method for preparing a soft tissue xenograft includes the steps of removing at least a portion of a soft tissue from a non-human animal to provide a xenograft; washing the xenograft in saline and alcohol; subjecting the xenograft to cellular disruption treatment; and either digesting the xenograft with a glycosidase or glycosidase digestion followed by treatment for sialylation. A soft tissue xenograft for implantation into a human includes a portion of a soft tissue from a non-human animal, wherein the portion has extracellular matrix and substantially only dead cells. The matrix and dead cells have substantially no surface &agr;-galactosyl moieties and have sialic acid molecules linked to at least a portion of surface carbohydrate moieties. Each of the xenografts of the invention has substantially the same mechanical properties as a corresponding native soft tissue.

Abstract: A delivery apparatus for self-expanding stents may be utilized to safely deliver stents to a target site. The apparatus has an outer sheath forming an elongated tubular member having distal and proximal ends and an inside and outside diameter. The apparatus also includes an inner shaft located coaxially within the outer sheath. The inner shaft has a distal end, a proximal end and a longitudinal axis extending therebetween. At least a portion of the inner shaft is made from a flexible coiled member. The shaft preferably includes a stop attached thereto, the stop being proximal to the distal end of the sheath. Lastly, the apparatus includes a self-expanding stent located within the outer sheath, wherein the stent makes frictional contact with the outer sheath and the shaft is disposed coaxially within a lumen of the stent. During deployment of the stent, the stent makes contact with the stop.

Abstract: A low profile, abdominal aortic aneurysm exclusion device with iliac vessel extensions. A sectional, bifurcated stent forms part of an endoluminal prosthesis to eliminate or reduce the risk of rupture of aortic aneurysms. An apparatus and a method for introducing the bifurcated stent in sections into the vasculature and assembling the sections in situ to form a “scaffold” for introduction of material to re-endothelialize and/or occlude the aneurysm cavity. After trans-stent embolization of the aneurysm cavity with thrombogenic material, laminar flow stimulates endothelialization of the stent lumen. Subsequent organization and fibrosis of the persistent thrombus reinforces the wire-mesh or etched metal tubular scaffold comprising the stent and serves to stabilize and shrink the aneurysm. A single stent deployed with the same method may be used in non-bifurcated vessels.

Abstract: A knee prosthesis and method for use are provided, in which the knee prosthesis provides anterior and posterior stability and controlled femoral roll-back, while also providing rotational kinematics. The femoral component has a pair of convexly shaped condyles which are spaced apart to form an intercondylar notch. Anterior and posterior cams are provided within the notch. The tibial component comprises a platform upon which a tibial bearing is mounted to provide for rotational movement about the tibial axis. The tibial bearing is provided with surfaces to engage the condyles and has an upwardly extending spine which is positioned to engage the anterior and posterior femoral cams. At full extension, the spine engages the anterior femoral cam to provide a 3° hyperextension stop. Between full extension and approximately 50° of flexion, the spine is free to translate between the anterior and posterior femoral cams.

Abstract: A heart valve prosthesis for use as an aortic or pulmonary replacement valve, or as a mitral or tricuspid valve includes leaflets that are reinforced through the use of oriented fiber components in a laminated composite, in which the leaflets of the valve are reinforced with fiber-reinforcing materials oriented along lines of stress in the material, thus to provide a long-lived valve that provides strength at points of maximal stress that have hitherto been foci for material failure. In a preferred embodiment involving a stentless valve, the reinforcing materials are optimized in terms of the density and orientation of the fibers in the composite materials, thus to extend the life of a stentless valve, with the valve requiring no anti-coagulants as is the case with mechanical valves and exhibiting no hemolysis in which red cells are damaged by the action of mechanical valves. Longevity exceeds thirty five years in most cases, making replacement of such a valve a remote possibility.

Abstract: An iris-supported intraocular lens having an optic portion and a plurality of fixation members coupled thereto. Each fixation member has a pair of pincer arms that separate outward of the optic and converge toward one another at aligned end tips. One or both of the end tips are covered with a soft sleeve or cap. The IOL is fixed in the anterior chamber of the eye by pinching the iris tissue between the end tips of each pair of pincer arms. The soft sleeves eliminate damage to the iris tissue.

Abstract: Disclosed are a prosthesis configuration and method for treating acquired flatfoot. In an exemplary embodiment of the invention, a member is positioned between a first bone in the foot and a second bone in the foot, such that the first and second bones are separated by a third bone, and a maximum force in the member is a tension force when the foot is under a standing load. The member is longitudinal and flexible.

Abstract: Improved tools for visualizing, sizing and/or marking include a prosthesis template with a diameter approximately equal to the diameter of an aortic heart valve prosthesis. In preferred embodiments, the prosthesis template has an annulus end and a sinotubular junction end wherein the diameter at the annulus end is less than the diameter at the sinotubular junction end. The prosthesis template can include a marking element configured to mark tissue at particular positions relative to the prosthesis template. Marking can be performed with a variety of techniques.

Abstract: A catheter having a distal end for insertion into a lumen of a patient's body includes a deployable semi-permeable membrane for trapping debris dislodged by a stent while allowing perfusion of body fluid through the membrane, mounted distally on said catheter; a stent mounted proximally of the membrane on the catheter; and a deployment system on the catheter for deploying the membrane in advance of deploying the stent. The deployment system is common to both the membrane and the stent. It includes a respective deployment balloon for each of the membrane and the stent. Deployment of the membrane in advance of the stent is controlled by differences in pressure-diameter characteristics of the respective deployment balloons. The deployable semi-permeable membrane is a selectively controllable collapsible mechanism.