Abstract: An apparatus for securing a marker wire relative to a lumen includes a hub to which the marker wire is secured. The hub includes a feature that secures the hub to an outer surface of the lumen. For example, the hub may include a base member secured to the marker wire and a separate fastener member which secures the hub to an outer surface of a lumen, where the base member includes a split tube segment that receives the lumen within an inner cylindrical opening. Alternatively, the hub may include a cylindrical slide lock collar member with a split tubular extension that receives the lumen within an inner cylindrical opening. Locking features may be included to help fix the two pieces of the hub in position relative to each other.

Abstract: An orthopedic anchoring system for attaching a spinal stabilization system and concomitantly fusing a sacroiliac joint is disclosed that includes a delivery tool and an implant assembly for insertion into a joint space of a sacroiliac joint. The implant assembly may be secured using anchors inserted through bores within the implant body and into the underlying sacrum and/or ilium. The implant body may also include an attachment fitting reversibly attached to a guide to provide attachment fittings for elements of the spinal stabilization system. The implant assembly may be releasably coupled to an implant arm of the delivery tool such that the implant arm is substantially aligned with the insertion element of the implant assembly. An anchor arm used to insert the anchor may be coupled to the implant arm in a fixed and nonadjustable arrangement such that the anchor is generally aligned with a bore within the implant assembly.

Abstract: Embodiments of the present invention relate to a therapeutic device (graft) comprising a collagen membrane having an aligned uniaxial or biaxial structure such that mammalian cells plated on the membrane align mainly along the direction of the collagen fibrils. In a further aspect, a graft comprising a substantially tubular body, wherein the body has an exterior surface, an interior surface, and at least one lumen extending therethrough such that a fluid flow through the lumen can direct mammalian cell migration. In a further aspect, mammalian cells or growth and angiogenic factors can be optionally attached to the exterior and/or interior surface of the substantially tubular body. In various aspects, the graft can be used as a vascular prosthesis, a stent, or a nerve regeneration scaffold. Methods of preparing and implanting same are also provided.

Abstract: A stented prosthetic heart valve including a stent assembly, a leaflet assembly, and mounting members. The stent assembly includes a stent post frame, a stent post frame covering, and a base frame. The stent post frame includes a continuous rail forming a closed-curved shape defining a longitudinal axis, and a plurality of circumferentially-spaced posts projecting from cusp segments in a direction of the longitudinal axis. The cloth covering encompasses the rail. The base frame supports the cusp segments. The valve leaflet assembly is attached to the stent assembly, and includes a leaflet clamped between one of the cusp segments and the base frame. The mounting members each directly pass through the stent post frame cloth covering, the first leaflet and the base frame. The rail can have a constant cross-sectional shape with a major axis dimension that is greater than a minor axis dimension.

Abstract: Methods and systems for introducing a delivery device, having a prosthesis, in the heart at or near the apex of the heart are provided. The methods include the steps of piercing the apex of the heart with a tissue piercing end of the delivery device, advancing the prosthesis to the target site and disengaging the prosthesis from the delivery device at the target site for implantation. The valve replacement systems are configured to deliver a replacement heart valve to a target site in or near a heart. The valve replacement system includes a trocar or other suitable device to penetrate the heart at or near the apex of the heart, a delivery member that is movably disposed within the trocar, and a replacement cardiac valve disposed on the delivery member. The delivery member optionally includes mechanical or inflatable expanding members for implantating the prosthetic valve at the target site.

Abstract: A method of making an implantable medical device includes extruding a first ePTFE tube and a second ePTFE tube, cutting a plurality of slits in the first ePTFE tube, positioning a radially expandable support layer between the first and second ePTFE tubes so that the slits span portions of the support layer, and laminating the first ePTFE tube to the second ePTFE tube through openings in the support layer.

Abstract: A bidirectional twistable stent is disclosed. The stent comprises a cylinder-shaped stent body having a plurality of axially arranged rows of struts encircling a central lumen and a plurality of flex connectors that connect at least two adjacent rows of struts in such a manner that allows the stent to be twisted clockwise or counter clockwise without causing deformation of any struts in the stent body. Also disclosed are the method of making the stent, method of using the stent, and a kit containing the stent.

Abstract: A stent graft includes a tubular graft element to which there are attached a plurality of stent rings. The stent rings are formed of a plurality of stent struts arranged in a zig-zag arrangement with alternating peaks and valleys. The end-most stent is located at the proximal end of the graft tube. Between adjacent peaks of the end most stent, there is provided a series of bridging elements. These are preferably formed of Nitinol wire and to be substantially more flexible than the stent struts. The bridging elements extend in the region of graft material between adjacent stent peaks and are attached to the graft material, for example by suturing. The bridging elements are substantially more flexible than the stent ring and therefore impart little opening force on the graft material in comparison to the force produced by the stent ring. However, the bridging elements impart enough force on the flaps of graft material between the peaks of the stent ring keep these flaps open, that is against the vessel wall.

Abstract: An annuloplasty ring having a three-dimensional discontinuous form generally arranged about an axis with two free ends that are axially offset. The ring is particularly suited for repair of the tricuspid valve, and more closely conforms to the annulus shape. The ring is more flexible in bending about radially extending axes than about the central axis. The ring may have an inner structural support covered by a pliable sleeve and/or a fabric tube. The structural support may have a varying cross-section, such as a C-shaped cross-section in a mid-section between two free ends and a rectangular cross-section at the free ends. A deliver template having a mounting ring with about the same shape as the ring facilitates implant, and may be releasably attached to a delivery handle. The deliver template may include a plurality of cutting guides for releasably attaching the annuloplasty ring thereto while presenting maximum outer surface area of the ring.

Abstract: A stent-graft, including a generally tubular vascular graft of biocompatible material, and a plurality of bio-resorbable discrete annular members spaced apart along a longitudinal axis of the vascular graft and attached thereto.

Abstract: A valve prosthesis device and methods for deployment is disclosed. 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 support structure includes strut members interconnected by rotatable joints to form a series of linked scissor mechanisms. The structure can be remotely actuated to compress or expand its shape by adjusting the scissor joints within a range of motion. In particular, the support structure can be repositioned within the body lumen or retrieved from the lumen. The support structure can be employed to introduce and support a prosthetic valve within a body lumen.

Abstract: A prosthetic mitral valve includes an anchor assembly, an annular strut frame, and a plurality of replacement leaflets secured to the annular strut frame. The anchor assembly includes a ventricular anchor, an atrial anchor, and a central portion therebetween. The annular strut frame is disposed radially within the anchor assembly. An atrial end of the annular strut frame is attached to the anchor assembly such that a ventricular end of the annular strut frame is spaced away from the anchor assembly.

Abstract: A method of treating vascular disease in a patient is disclosed that comprises deploying a bioabsorbable polymer scaffold composed of a plurality of struts at a stenotic segment of an artery of a patient, wherein after the scaffold supports the segment at an increased diameter for a period of time the polymer degrades and is progressively replaced by de novo formation of malleable provisional matrix comprising proteoglycan, wherein as the scaffold becomes more malleable and becomes disconnected as it degrades, wherein following coverage of the struts by a neointima layer and loss of mechanical support provided by the scaffold, the scaffold is pulled outward by positive remodeling of the vessel wall of the scaffolded segment.

Abstract: Apparatus and methods for preparing a bone socket, such as the glenoid of the scapula, to receive a prosthetic component. The apparatus is an orthopedic instrument (reamer) used for the preparation of bone surface for the insertion of an implant. The reamer includes an elongate shaft, a connecting system (for example, a quick connect system), and a cutting head having a specific configuration, i.e., in the shape of a Nautilus shell having a logarithmic spiral. The cutting head is provided with a plurality of spokes that have different radii or lengths (that confer a non-constant non-uniform radius to the overall cutting head).

Abstract: A stent includes a first section and a second section. The first section and the second section each include a plurality of expandable modules and a plurality of bridging modules. Each expandable module includes a plurality of strut elements that join together at a plurality of apices, and each bridging module includes bridging elements that connect an apex of a first module with an apex of a second module. In some aspects, the first section is more flexible along the longitudinal axis of the stent than the second section and is configured to be placed in a specific region of a vessel that requires flexibility to accommodate surrounding anatomy. In some aspects, the first section is more radially stiff than the second section and is configured to be placed in a specific region of the vessel that requires radial stiffness to counteract crushing force caused by surrounding anatomy.

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 method of stenting, comprises: implanting a stent assembly in a vessel of a subject, the stent assembly, including: a stent jacket, comprising an expansible mesh structure, formed of fibers of a diameter between about 7 micrometers and about 18 micrometers, the diameter having a property of forming a substantially stable layer of endothelial cells, covering the fibers, thus reducing platelet aggregation, and an expansible stent, operatively associated with the stent jacket. The method further comprises administering to the subject an active pharmaceutical ingredient (API) comprising a platelet aggregation reducer for a shortened time period, not exceeding six months, the shortened time period being a consequence of the property. In accordance with some embodiments, the administration of a platelet aggregation.

Abstract: A prosthetic heart valve configured to replace a native heart valve and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein is disclosed, together with methods of using same. The prosthetic heart valve may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace a native valve (or other prosthetic heart valve), but to assume a generally expanded form when subjected to an outward force such as that provided by a dilation balloon or other mechanical expander.

Abstract: The present invention comprises articles and methods for atraumatic removal of a chronically implanted medical device, such as a vascular graft. Specifically, the invention comprises a thin, lubricious and durable tubular cover that aids in protecting the indwelling implant during implantation while also acting as an atraumatic removal aid.