Abstract: Valve devices, methods of making valve devices, and methods of treating various venous-related conditions, disorders and/or diseases are described. In one embodiment, a valve device includes an expandable support frame and a bioprosthetic valve attached to the support frame. The bioprosthetic valve comprises a leaflet and a contiguous wall portion harvested from a multi-leaflet xenogeneic valve. The contiguous wall portion includes the attachment region where the leaflets attaches to the vessel wall and, in some embodiments, includes the natural margins of attachment between the leaflet and vessel wall.

Abstract: Prosthetic valved conduits are provided that include a leaflet construct coupled between two portions of a conduit. Each leaflet has a free edge and a leaflet attachment edge. The leaflet attachment edge is disposed between a first conduit distal end and a second conduit proximal end that are coaxial therebetween defining a junction.

Abstract: A cardiac valve prosthesis including an armature for anchorage of the valve prosthesis at an implantation site. The armature defining a lumen for the passage of the blood flow and having a longitudinal axis, and a set of prosthetic valve leaflets supported by said armature and configured to move, under the action of blood flow, in a radially divaricated condition to enable the flow of blood through said lumen in a first direction, and in a radially contracted condition, in which said valve leaflets co-operate with one another and block the flow of blood through the prosthesis in the direction opposite said first direction.

Abstract: A lumen stent preform is provided using a plasma nitriding technology, a preparation method thereof, a method for preparing a lumen stent by using the preform, and a lumen stent obtained according to the method. The preform is manufactured by using pure iron or an iron alloy containing no strong nitrogen compound, has a hardness of 160-250HV0.05/10, and has a microstructure that is a deformed structure having a grain size scale greater than or equal to 9 or a deformed structure after cold machining. Alternatively, the preform is an iron alloy containing a strong nitrogen compound, and has a microstructure that is a deformed structure having a grain size scale greater than or equal to 9 or a deformed structure after cold machining. The lumen stem preform meets the requirements of a conventional stent for radial strength and plasticity, so that plasma nitriding is applicable to commercial preparation of a lumen stent.

Abstract: Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve. In one embodiment, for instance, a support structure and an expandable prosthetic valve are advanced through the aortic arch of a patient using a delivery system. The support structure is delivered to a position on or adjacent to the surface of the outflow side of the aortic valve (the support structure defining a support-structure interior). The expandable prosthetic valve is delivered into the aortic valve and into the support-structure interior. The expandable prosthetic heart valve is expanded while the expandable prosthetic heart valve is in the support-structure interior and while the support structure is at the position on or adjacent to the surface of the outflow side of the aortic valve, thereby causing one or more native leaflets of the aortic valve to be frictionally secured between the support structure and the expanded prosthetic heart valve.

Abstract: Gluteal implants and gluteal implant systems are described herein, as are methods of manufacturing and implanting the same. In certain embodiments, the gluteal implant includes a body having a convex upper surface, a concave lower surface, and an edge, the edge being formed by the intersection between the convex upper surface and the concave lower surface. The body can take on various shapes, including a truncated ovoid shape, a truncated approximate ovoid shape, a truncated substantially ovoid shape, a truncated ellipsoid shape, a truncated approximate ellipsoid shape, or a truncated substantially ellipsoid shape, among others. In certain embodiments, the gluteal implant system includes first and second gluteal implants that have the same or different shaped bodies. In certain embodiments, the gluteal implants and gluteal implant systems are implanted in a buttock region.

Abstract: A method and system discloses a medical device comprising a pre-crimped stent mounted on an inflatable means for inflating the pre-crimped stent. The pre-crimped stent mounted on an inflatable means further includes a membrane with a centrally positioned opening with a second expandable diameter, wherein the membrane covers one end of the pre-crimped stent, thereby reducing pulmonary flow in a pulmonary artery.

Abstract: An implant includes: a sinusoidal container that includes: a plurality of projections; a plurality of troughs; and a plurality of smooth interfaces, wherein a smooth interface is interposed between a projection and an adjacent trough for the plurality of projections, troughs, and interfaces to provide a smooth continuous transition between adjacent projections and troughs. A process for making an implant includes: forming a sinusoidal container from a polymer, the sinusoidal container including: a plurality of projections; a plurality of troughs; and a plurality of smooth interfaces, wherein a smooth interface is interposed between a projection and an adjacent trough for the plurality of projections, troughs, and interfaces to provide a smooth continuous transition between adjacent projections and troughs; and providing a filling tube attached to the sinusoidal container to make the implant.

Abstract: An annuloplasty band and method of implantation. The band is shaped and sized to avoid the adjacent aortic valve structure and better protects against dehiscence along the muscular mitral annulus. The band is asymmetric and when implanted spans more around the side of the mitral annulus having the posterior commissure than the side with the anterior commissure. The band has a saddle shape with a posterior upward bow centered on a minor axis of the mitral annulus, and a span extending clockwise therefrom is longer than a span extending counter-clockwise. The longer span may be 150° while the shorter span extends 90°. A set of rings may have different saddle profiles and different plan view shapes for different sized bands. A method includes implanting so that the band extends over the posterior leaflet and a short distance past the posterior commissure outside of the anterior leaflet.

Abstract: A prosthetic heart valve has a frame including a plurality of strut members, an inflow end, and an outflow end. A leaflet structure is situated at least partially within the frame, and a covering is disposed around an exterior of the frame. The covering includes a cushioning layer, and a first strip member folded over an inflow circumferential edge portion of the cushioning layer to form a first protective portion. A second strip member is folded over an outflow circumferential edge portion of the cushioning layer to form a second protective portion. The first strip member and the second strip member are spaced apart from each other along a longitudinal axis of the prosthetic heart valve.

Abstract: The present invention comprises a novel and safer mechanism of deployment using a self-positioning, self-centering, and self-anchoring method. To embody the present invention, a disk-based valve apparatus allowing the repositioning and retrieval of the implantable valve while working on a dysfunctional valve structure is disclosed. The disk-based valve apparatus may comprise one or more disks, either proximal or distal, a valve-housing component and a valve component. The one or more disks may be either proximal or distal, may be either connected to each other or disconnected from each other and may either be symmetrical or have different shapes and dimensions. The disk-based valve apparatus may be self anchoring, such as anchored by pressure from the one or more disk, or may be anchored using any anchoring.

Abstract: A method of providing a Vertebral Body Replacement (VBR) device for placement into a cervical spine between two endplates of a single vertebra during the course of an anterior spinal surgical procedure upon the cervical spine, wherein the VBR device has been given a PLR product code from the Food and Drug Administration (FDA).

Abstract: A method of forming an implant having a porous tissue ingrowth structure and a bearing support structure. The method includes depositing a first layer of a metal powder onto a substrate, scanning a laser beam over the powder so as to sinter the metal powder at predetermined locations, depositing at least one layer of the metal powder onto the first layer and repeating the scanning of the laser beam.

Abstract: Disclosed herein are various embodiments of cardiac anchors configured to be inserted into a heart wall of a patient to anchor a suture as an artificial chordae under an appropriate tension for proper valve function. Such cardiac anchors are particularly suitable for use in intravascular, transcatheter procedures.

Abstract: A two-part joint replacement device for replacing damaged soft joint tissue, such as a meniscus or cartilage tissue. In one form, the device may include a free floating soft joint tissue replacement component comprising a first tissue-interface surface shaped to engage a first anatomical (bone and/or cartilage) structure of a joint having damaged soft tissue. The device may also include a free floating rigid base component comprising a second tissue-interface surface shaped to engage a second anatomical (bone and/or cartilage) structure of the joint. The free floating soft joint tissue replacement component may be shaped to slidably interface with the rigid base component. In another form, the free floating soft joint tissue replacement component and the rigid base component are fixed together.

Abstract: A replacement heart valve prosthesis is loaded onto a balloon mounted onto a balloon shaft of a catheter system. The balloon shaft is rotatably engaged with an actuator on the handle of the catheter system. Rotation of the actuator by a first amount in a first direction permits rotation of the heart valve prosthesis by a known amount during the procedure so that alignment of the commissures of the replacement valve with the commissures of the existing valve can be predictably achieved.

Abstract: A minimally invasively implanted anchor support for securing a medical prosthesis device with a tether to an implanted anchor. The anchor support includes a lock cap for connecting to the anchor, a tether swivel connected to the lock cap, a tock cone within the tether swivel and a tether collar on a proximal end of the tether swivel. An anchor support delivery system cooperates with the anchor support for securing to the lock cap.

Abstract: A prosthetic heart valve including a stent frame and a valve structure. The valve structure is disposed within a lumen of the stent frame. The stent frame is configured to self-expand from a compressed condition for transluminal delivery. The stent frame has a lattice structure forming a tubular shape defining a circumference and a plurality of closed cells arranged to define a band exhibiting a variable radial stiffness. The prosthesis can be deployed such that the band applies a minimal force on to anatomical locations relating to the heart's conductive pathways. A region of the band otherwise having low radial stiffness is located at or over a conductive pathway upon final implant.

Abstract: A prosthetic heart valve and delivery system adapted to facilitate transapical or transfemoral implantation of a prosthetic heart valve, the delivery system comprising an elongated sheath or shaft have one or more loop stabilization wires adapted to circumscribe and crimp a metallic stent, the loop stabilization wires releasable with retraction of an engagement pin to expand the metallic stent and anchor the same in native tissue within the circulatory system of a patient.

Abstract: A self-closing device for implantation within a patient's body includes base material including an inner surface area for securing the base material to a tissue structure, and a plurality of support elements surrounding or embedded in the base material. The support elements are separable laterally within a plane of the base material to accommodate creating an opening through the base material for receiving one or more instruments through the base material, and biased to return laterally towards a relaxed state for self-closing the opening after removing the one or more instruments. The device may be provided as a patch or integrally attached to a tubular graft or in various shapes.