Abstract: A prosthetic mitral heart valve having four separate flexible leaflets. The heart valve includes a support frame that may be non-circular, for example elliptical or “D-shaped”. The support frame may have an undulating outflow edge defined by four inflow cusps and four outflow commissures to which each of the flexible leaflets attaches. The support frame may comprise an undulating wireform and a surrounding stent defining a structure having four cantilevered posts projecting in the outflow direction to support the four leaflets. The heart valve is designed to be secured in the annulus and function as a standalone unit without papillary muscle connections to the leaflets. The four leaflets may be arranged in two opposed pairs, one pair being smaller than the other pair. The larger pair of leaflets may be identical, or differently sized. Existing sizes of heart valve leaflets may be utilized with the smaller leaflets being at least two leaflet sizes smaller than the larger leaflets in odd millimeter increments.

Abstract: The present teachings provide for a graft fixation assembly including a base member, a compression member, and a fastener. The base member includes a bone engaging surface and a first graft engaging surface opposite to the bone engaging surface. A plurality of first fixation members extend from the bone engaging surface and are configured to be impacted into bone. The compression member includes a second graft engaging surface and an outer surface opposite to the second graft engaging surface. The fastener is configured to secure the compression member relative to the base member such that a graft between the base member and the compression member is compressed therebetween and secured to the graft fixation assembly.

Abstract: An apparatus for automatically fixing sutures used in the surgical replacement of a heart valve, including a first cylinder having a first end and a second end and an interior surface and an exterior surface, and first means for securing fixing suture formed on the exterior surface adjacent to the second end of the first cylinder. The apparatus also includes a second cylinder having second means for securing fixing suture formed on an interior surface of the second cylinder, such that the second means corresponds to and fixedly engages the first means for securing fixing suture, and the first means and the second means secure fixing sutures therebetween.

Abstract: Implantable medical devices may be utilized to locally delivery one or more drugs or therapeutic agents to treat a wide variety of conditions, including the treatment of the biological organism's reaction to the introduction of the implantable medical device. These therapeutic agents may be released under controlled and directional conditions from a stent so that the one or more therapeutic agents reach the correct target area, for example, the surrounding tissue.

Abstract: The ankle joint prosthesis adapted to involve the patient's distal tibia and talus has, according to the present invention, tibial, talar and mobile or semi-constrained bearing components that are laterally to medially implanted in the patient. The tibial component's top surface has convex curvature in its anterior to posterior plane and is configured so as to approximate and match with the curvature of a prepared portion of the distal tibia; its bottom surface being approximately flat. The talar component's top surface has saddle-shaped, convex curvature in its anterior to posterior plane, it's bottom surface has concave curvature and is configured so as to approximate and match with the curvature of a prepared portion of the talus. The mobile or semi-constrained bearing components have embodiments that comprise a wide variety of geometric shapes. A method for implanting such a prosthesis is also disclosed.

Abstract: A venous valve apparatus, system and method for valve replacement. The valve includes a valve frame, a valve leaflet joined to the valve frame, and a support frame. The valve leaflet includes surfaces defining a reversibly sealable opening for unidirectional flow of a liquid. The support frame meets the valve frame on an axis, where the valve frame and the support frame extend from the axis in an opposing direction. The system further includes a catheter, where the valve can be reversibly joined to the catheter at a location between a proximal end and a distal end of the catheter. The system can be used to deploy the valve from the catheter at a predetermined location.

Abstract: Apparatus and method for accessing the wall of a body lumen while simultaneously providing zone isolation and fluid bypass capability, the apparatus comprising: an erectable proximal isolation barrier capable of making a sealing engagement with the wall of the body lumen; an erectable distal isolation barrier capable of making a sealing engagement with the wall of the body lumen; a bypass channel secured to, and extending between, the proximal isolation barrier and the distal isolation barrier, the bypass channel comprising a lumen communicating with the region proximal to the proximal isolation barrier and with the region distal to the distal isolation barrier; and a working catheter passing through the proximal isolation barrier and terminating short of the distal isolation barrier, the working catheter providing a central lumen for providing access to the wall of the body lumen between the proximal isolation barrier and the distal isolation barrier.

Abstract: A method and system according to one embodiment may include a plurality of apparatus configured to percutaneously deliver a heart valve implant. The method and system may include an implant comprising an anchor configured to engage cardiac tissue, a shaft coupled to the anchor, and a valve body coupled to the shaft. The method and system may further include at least partially collapsing the heart valve implant and percutaneously inserting the heart valve implant into a heart. The percutaneously inserted implant may be secured within the heart and may then be expanded.

Abstract: A valve prosthesis device and methods for deployment is disclose. The device comprises an expandable support stent and a valve assembly comprising a flexible conduit having an inlet end and an outlet, made of pliant material attached to the support beams providing collapsible slack portions of the conduit at the outlet. Flow is allowed to pass through the valve prosthesis device from the inlet to the outlet, but reverse flow is prevented as the collapsible slack portions of the valve assembly collapse inwardly. The device is configured so that retrograde flow will be altered from laminar flow and directed towards the leaflets to effect closing. The device can be deployed in a native heart valve position using a deployment catheter advanced through a body lumen such as a blood vessel, including an aorta.

Abstract: A heart valve prosthesis configured for placement at a mitral valve in the heart is disclosed that includes a stent-like support structure for supporting a prosthetic mitral valve. The support structure is configured to have a low ventricular profile with only a short length thereof protruding into the left ventricle when deployed in vivo. The support structure includes an upstream section that is outwardly expandable to sit against the atrial wall so as to at least partially anchor the prosthesis therein and a downstream section to which the prosthetic mitral valve is coupled that extends between the left atria and ventricle through the native mitral valve. The low-ventricular profile of the prosthesis is achieved by shaping the support structure such that the downstream section extends within and overlaps with the upstream section at given regions around the circumference of the support structure in an expanded configuration.

Abstract: A generally spherical vascular remodeling device is permanently positionable at a junction of afferent and efferent vessels of a bifurcation having an aneurysm. After positioning the device at the junction to substantially conform the device to the shape of the junction, the device acts as a scaffolding to inhibit herniation of objects out of the aneurysm and the device permits perfusion to the efferent vessels. Positioning the device may include deployment and mechanical or electrolytic release from a catheter. Embolic material may be inserted in the aneurysm before or after positioning the device. The device may have a first end, a second end substantially opposite to the first end, and a plurality of filaments extending between and coupled at the first end and the second end. Such devices may be football shaped, pumpkin shaped, or twisted. The device may include a plurality of loops forming a generally spherical shape.

Abstract: Method and apparatus for mapping the shape and dimensions of a 3-dimensional body, by applying to the 3-dimensional body a stretchable covering configured and dimensioned such that in its stretched condition it tightly engages and conforms to the shape and dimensions of the 3-dimensional body to be mapped. The stretchable covering carries a plurality of reference devices, such as bands and/or markers which are at known or determinable reference locations in an initial condition of the covering, and which change their locations in the stretched condition of the stretchable covering according to the shape and dimensions of the 3-dimensional body covered thereby. The locations of the markers on the stretchable covering are determined after the stretchable covering has been applied to the 3-dimensional body, and are utilized to produce a map of the shape and dimensions of the 3-dimensional body.

Abstract: A flat sheet of woven material includes warp yarns and weft yarns interlaced at substantially right angles to each other. A graft material is cut from the flat sheet of woven material such that the graft material includes a graft material longitudinal axis and the warp yarns are disposed at an angle relative to the graft material longitudinal axis. The warp yarns and weft yarns are not parallel to or perpendicular to the graft material longitudinal axis. The graft material is formed into the shape of an endoluminal prosthesis, such as by rolling opposing edges towards each other and securing the opposing edges to each other. The endoluminal prosthesis thus includes warp yarns disposed at an angle relative to the prosthesis longitudinal axis.

Abstract: An interspinous implant. The interspinous implant includes a resilient S-shaped body having first and second saddle-shaped portions. First and second stirrup-shaped brackets extend in opposite directions from the first and second saddle-shaped portions for engaging first and second spinous processes.

Abstract: A method of implanting a lateral unicondylar knee prosthesis in a lateral articulating portion of a femur having a lateral condyle for engagement with a tibia, the method including the steps of: bending a patients knee such that the knee is not in full extension; making an incision through the skin, muscle, and other soft tissue until the damaged bone surfaces are exposed; resecting an end portion of the lateral tibia; resecting an end portion of the lateral femoral condyle; attaching a tibial prosthetic component to the resected end portion of the tibia; attaching a lateral femoral condyle prosthetic component to the resected end portion of the lateral femoral condyle; determining the thickness of a mobile bearing member with the knee in full extension; and inserting the mobile bearing member between the tibial prosthetic component and the femoral prosthetic component.

Abstract: A trial acetabular cup having a signal generating device located thereon.

Abstract: A biodegradable and/or bioabsorbable composite stent includes a bioabsorbable ceramic material dispersed and embedded in a biodegradable polymeric material. The bioabsorbable ceramic material is made of flakes that have a thin, flat shape. In one embodiment, the composite stent comprises a body of one or more layers of polymer alone coupled to layers of polymer in which the ceramic flakes are dispersed and embedded and the composite is coiled to form the stent.

Abstract: A stent assembly including a stent configured to be positioned in a body lumen, and a knitted stent jacket including an expansible mesh structure having a coverage area of less than 25%, having approximate aperture diameters greater than 20 micrometers, and surrounding an external surface of the stent and coaxially associated therewith, wherein the stent assembly elutes an amount of an active pharmaceutical agent.

Abstract: Instruments and methods for distracting an intervertebral space and inserting and impacting artificial intervertebral discs. A wedge distractor employing opposing ramps through which an inserter/impactor holding an artificial intervertebral disc is admitted, the passage of which through the distractor results in distraction of the intervertebral space simultaneous with insertion of the artificial intervertebral disc. A method of distracting an intervertebral space comprising the steps of inserting a distractor having opposing ramped surfaces into an intervertebral space and inserting an inserter/impactor holding an artificial intervertebral disc between the opposing ramped surfaces of the distractor to insert/impact the artificial intervertebral disc in the intervertebral space. A system for distracting an intervertebral space employing a wedge distractor, inserter/impactor and artificial intervertebral implant.

Abstract: A positioning anchor is provided for a stent-graft for implantation to treat a damaged body lumen. The positioning anchor is generally tubular surrounding a primary fluid conduit. Arms extend laterally from the generally tubular structure of the anchor surrounding lateral fluid conduits. The form of these arms is preferably custom configured to match a particular patient's luminal geometry. The anchor thus fits within the luminal geometry to remain in a desired fixed position for implantation of the anchor and any stent-graft coupled to the anchor. The anchor is most preferably formed with two walls having a void therebetween which can be filled with fixation media to further secure the anchor at the desired implantation site. A lumen shaper balloon and delivery catheter are also disclosed for proper delivery, expansion and inflation of the positioning anchor and stent-graft elements according to this invention.