Abstract: A prosthetic spacer assembly includes a spacer body, a first anchor, and a second anchor. The first anchor and the second anchor are each connected to the spacer body. The first anchor is configured to capture a first native valve leaflet between the first anchor and the spacer body. The second anchor is configured to capture a second native valve leaflet between the second anchor and the spacer body.

Abstract: A component of an artificial joint according to an exemplary aspect of the present disclosure includes, inter alia, a hollow tube including bone ingrowth material. Further, the hollow tube is selectively expandable. The bone ingrowth material allows the component to become biologically fixed to adjacent bone. Further, expansion of the hollow tube increases friction between the hollow tube and the adjacent bone, which increases stability.

Abstract: A method for transcatheter delivery to a native heart valve needing replacement. A first component is attached to the native annulus upstream of the native leaflets maintaining native leaflet function, and is held to the native annulus by barbs that are activated by a torus balloon after the first component is fully expanded. The torus balloon can be implanted along with the support frame. A limiting cable restricts further expansion of the first component and holds a second component that contains the replacement leaflets.

Abstract: The present invention relates to a raw material for a bio-3D printing support and, more specifically, to a novel type bio-3D printing support material for tissue engineering, a method for manufacturing a three-dimensional support by using the same, and a 3D-printing three-dimensional support manufactured thereby, the raw material: being non-toxic and implementing excellent biocompatibility and cell adhesion since a raw material for a tissue engineering support (scaffold) produced by bio-3D printing technology, a specific fatty acid and a fatty alcohol (phase change material) derived from a natural source having a low melting point and a low molecular weight are used; and, in particular, allowing a phase change to easily occur at a temperature similar to body temperature such that a process is simplified and cells or growth factors can be mixed.

Abstract: System, including apparatus and methods, for ankle fusion using a device for separating a first bone and a second bone of an ankle region. In some embodiments, the device may comprise an expandable spacer including first and second bone-contacting surface regions facing away from one another and configured to be abutted with the first and second bones, respectively. A distance between the first and second bone-contacting surface regions may be adjustable to change the separation of the first and second bones. The first bone-contacting surface region may correspond to a portion of a sphere and may be configured to be disposed at least partially in a concavity formed surgically in the first bone. The expandable spacer offers improved control over the length of the lower limb and the orientation of the foot during ankle fusion surgery.

Abstract: A pre-sutured allograft construct and method of manufacture for repairing, replacing, reconstructing, or augmenting a hip or shoulder labrum may include a folded tissue portion extending from a first end to a second end and forming top, middle, and bottom folds. A stitched pattern secures the folded tissue portion into a graft roll having an overall length extending from a first adjustable region, through a central region, and through a second adjustable region. A continuous series of whip stitches extends from the first adjustable region, through the central region, and through the second adjustable region. A series of triple circumferential stitches overlays the whip stitches in the first and the second adjustable regions, while a series of circumferential stitches alternates with the whip stitches in the central region. The construct is pre-manufactured as an allograft product, but is adjustable during the surgical procedure within the body. Other embodiments are also disclosed.

Abstract: Unicondylar tibia implant devices having a bone-facing, distal side that can be detailed with cement fixation features and may include any of or a plurality of grooves, pegs, fins, rails, cavities, and/or coating whereby the geometry of the implant device improves implant-to-cement or cement-to-bone fixation characteristics exceeding that of a traditional flat surface. The implant device may also include a proximal side facing away from the bone-facing, distal side and having a geometry that provides either articulation with (cartilage and meniscal substituting) or receipt of a secondary device coupleable to the implant device on the distal side of the secondary device that features an away-from-bone facing articulating feature. Additionally, the geometry of the implant device in anterior-posterior and medial-lateral directions, among other directions, provides a variety of improvements relative to currently available devices.

Abstract: A high-strength absorbable internal fixation bone screw for a fracture. The bone screw is made of a degradable oriented polylactic acid section. A raw material for the oriented polylactic acid section is a poly(L-lactic acid). The specific optical rotation of the poly(L-lactic acid) is ?155° to ?160°. The section is made of the poly(L-lactic acid) through the processes of making a billet, orientation strengthening and quenching in order. The method for making the billet is plastic injection molding. The method for orientation strengthening is forging and pressing or extrusion. The section is turned, finely milled, or directly molded into the bone screw. The bone screw has high strength and a low rate of mechanical strength loss, ensures mechanical support during bone healing and sufficient healing time for an injured bone, has good biocompatibility, and can be degraded and absorbed.

Abstract: This disclosure describes manufacturing of a device configured to guide bone and tissue regeneration for a bone defect. A method may include receiving a three-dimensional digital model or scan representing an anatomical feature to be repaired, generating a simulated membrane using the three-dimensional model, the simulated membrane being configured to cover the anatomical feature to be repaired, generating a digital two-dimensional flattened version of the simulated membrane, and generating code or instructions configured to cause a three-dimensional printer or milling device to produce a trimming guide that includes an opening corresponding to the flattened version of the simulated membrane and that further includes a cut-out configured to hold a premanufactured membrane. The trimming guide may be operative as a guide for marking or cutting the premanufactured membrane through the opening while the premanufactured membrane is held in the cut-out.

Abstract: A joint replacement system for repairing an articular surface of a first bone of a joint includes an anchor portion and an implant portion. The anchor portion includes an anchor to be secured to the bone, and an anchor fixation head including a bone-facing surface (BFS) extending radially outward from the anchor and an implant facing surface (IFS) extending from a periphery of the BFS. The implant portion is formed from a material (e.g., CoCr) more dense than the material of the anchor portion (e.g., Ti) and includes a fixation cavity to receive at least a portion of the anchor fixation head (AFH), the fixation cavity includes an anchor facing surface (AFS) configured to form a frictional connection with the IFS, and a load bearing surface having a contour for articulating against a cooperating articulating surface of a second bone of the joint.

Abstract: A system for treating a body lumen including a first stent configured to be positioned in a body lumen and a second stent configured to be positioned in the lumen of the first stent prior to removing the first stent from the body lumen. The first stent includes a liner disposed radially inward of the tubular scaffold of the first stent to permit tissue ingrowth within a tissue ingrowth region defined between the liner and the tubular scaffold. The retrieval stent is configured to be expanded within the previously implanted first stent to cause tissue to recede from the tissue ingrowth region to facilitate removal of the first stent from the body lumen.

Abstract: A prosthetic apparatus for implantation in a native heart valve includes a main body for placement within the native annulus. The main body is compressible to a radially compressed state for delivery into the heart and is self-expandable from the compressed state to a radially expanded state for implantation. A valve structure is mounted within a lumen of the main body and preferably forms three leaflets made of pericardium. Ventricular anchors are coupled to a ventricular end portion of the main body. The ventricular anchors are adapted to be straightened for delivery to the native heart valve and are biased to spring back to a pre-formed bent shape for capturing the native heart valve leaflets between the main body and the ventricular anchors. An atrial sealing member may be provided along an atrial portion of the main body for impeding the flow of blood between the main body and the native annulus.

Abstract: A bioprosthetic valve for repairing a deep venous insufficiency in a subject includes a single leaflet from a xenogeneic heart valve attached at natural margins of attachment to a patch of valve wall tissue. The patch may extend axially above and below the leaflet and circumferentially on either side of the leaflet to provide a region for attaching the patch to a fenestration in a host vein. A bioprosthetic valve may be manufactured by excising a portion of a xenogeneic heart valve including a single leaflet and contiguous wall tissue, and may further comprise shaving off excess leaflet tissue from adjacent leaflets. A method of replacing a malfunctioning venous valve in a subject includes providing a bioprosthetic valve as described above and inserting it to the host vein.

Abstract: A tibial implant may include a plurality of geometrically conformal implant subunits. The implant subunits may be configured for individual insertion within a wedge-shaped-void of the tibia. The implant subunits may further be configured for assembly in order to provide an implant substantially covering an exposed portion of cortical bone formed when performing a surgical osteotomy. In some embodiments, some or all of the plurality of subunits may be mechanically interlocked with each other. Methods and kits for insertion and assembly of implants are further described.

Abstract: A medical device comprising a substantially flexible porous structure. The porous structure comprises a plurality of interlocking units. Each of the plurality of interlocking units comprises a body and at least one arm. The plurality of interlocking units is configured to have space between adjacent interlocking units when the porous structure is in a neutral configuration. The plurality of interlocking units is configured to contact the respective body and arm of adjacent interlocking units when a compressive force is applied to the porous structure, thereby restricting compression of the porous structure. The plurality of interlocking units is configured to contact the respective arms of adjacent interlocking units when an extension force is applied to the porous structure, thereby restricting extension of the porous structure.

Abstract: A tendon repair suture tape comprising a flat braid of elastic, absorbable fibers and high strength fibers, the tape being at least 1 mm wide and 2 cm long, and less than 0.2 mm high. The suture tape includes at least 4 absorbable fibers and at least 4 high strength fibers. Further, the suture tape is capable of being stretched at least 10% from its shortest length to the length at which it breaks, presents an increasing resistance to further stretching as it is stretched, and is capable of withstanding a load of at least 260 Newtons before breaking.

Abstract: A system and method used to fabricate an implant from cartilage, where the implant can be used in reconstructive surgery. The system includes a thermoregulation device capable of maintaining a desired temperature range during milling operations. The milling machine is controlled by instructions generated from a digital model of the implant. The digital model can be a stock model or a custom model created from medical scans.

Abstract: The invention relates to a device for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation assistance element for implantation across the valve; a system including the coaptation assistance element and anchors for implantation; a system including the coaptation assistance element and delivery catheter; and a method for transcatheter implantation of a coaptation element across a heart valve.

Abstract: Devices and methods for assisting valve function, replacing venous valves, and predicting valve treatment successes. In an exemplary embodiment of an endograft body configured for expansion within a luminal organ, the endograft body comprises (a) a first portion having a proximal end defining a proximal end aperture and a distal end defining a distal end aperture, the first portion configured to increase a velocity of fluid flowing therethrough, (b) a second portion having a second portion proximal end defining a second portion proximal end aperture and a second portion distal end defining a second portion distal end aperture, wherein the distal end of the first portion is adjacent to the second portion proximal end, and (c) a valve portion positioned at or near the second portion proximal end, the valve portion configured to receive the fluid flowing through the distal end aperture of the first portion.

Abstract: Methods of modifying the luminal profile of a body vessel are described. An example method comprises advancing a cannula out of the distal end of a catheter disposed within the lumen of a body vessel of an animal and toward a target site on the wall of the body vessel; passing contrast dye through the cannula toward the target site; simultaneously continuing the advancing and passing until the distal end of the cannula punctures the inner layer of the wall of the body vessel at the target site; and passing a bulking agent through the cannula and into a space between connective tissue layers surrounding the vessel wall at the target site. Medical devices, medical device assemblies, and kits are also described.