Abstract: A heart valve prosthesis is provided having a self-expanding multi-level frame that supports a valve body comprising a skirt and plurality of coapting leaflets. The frame transitions between a contracted delivery configuration that enables percutaneous transluminal delivery, and an expanded deployed configuration having an asymmetric hourglass shape. The valve body skirt and leaflets are constructed so that the center of coaptation may be selected to reduce horizontal forces applied to the commissures of the valve, and to efficiently distribute and transmit forces along the leaflets and to the frame. Alternatively, the valve body may be used as a surgically implantable replacement valve prosthesis.

Abstract: A prosthetic heart valve comprises a biological tissue valve and a collapsible and expandable support frame having a longitudinal axis. The frame comprises an outflow circumferential structure defining an outflow end of the frame and consisting essentially of a single row of diamond-shaded expandable cells. The frame also comprises three V-shaped structures spaced apart from the outflow circumferential structure and three struts longitudinally aligned with the longitudinal axis of the frame. The three struts are configured to facilitate mounting the biological tissue valve to the frame and interconnect the outflow circumferential structure to the three V-shaped structures. The frame also includes three undulating structures, each of the three undulating structures interconnecting respective adjacent V-shaped structures of the three V-shaped structures.

Abstract: A burr hole plug includes a plug base configured for being mounted around a burr hole. The plug base includes an aperture through which an elongated medical device exiting the burr hole may pass. The plug base is configured to accommodate a variety of cranium forms without requiring deformation of the plug base. A plug base holding tool is used to secure the plug base to the cranium, wherein the tool aligns fasteners with the plug base for insertion through the plug base and into the cranium. The burr hole plug further includes a retainer configured for being mounted within the aperture of the plug base to secure the medical device. The retainer includes a clamping mechanism that secures the elongated medical device in the burr hole plug, wherein the movement of the clamping mechanism is controlled to prevent skewing of the clamping mechanism.

Abstract: The invention is direction to an alignment apparatus comprising a central sheath, an alignment sheath, and at least one stent. The central sheath and the alignment sheath each have a wall and a distal end where the wall of the alignment sheath is engaged to the wall of the central sheath. The wall of the central sheath defines a central lumen that has a central guide wire extending therethrough and the wall of the alignment sheath defines an alignment lumen that has an alignment guide wire extending therethrough. The distal end of the alignment sheath is positioned proximally to the distal end of the central sheath. The alignment apparatus has at least one stent disposed about one of the alignment guide wire or the central guide wire. The at least one stent has a pre-delivered state so that when the at least one stent is in the pre-delivered state, it is contained within at least one of the central sheath and the alignment sheath.

Abstract: A brace for supporting an exterior surface of a damaged bone including a plurality of elongated members interconnected at each of intermediate overlapping and end-to-end locations. An additional pair of end disposed supports is pivotally interconnected to outermost of the elongated interconnected members. A pair of elongated ties seating through apertures formed in the end disposed supports. The brace is adapted to being placed in encircling fashion over the damaged bone, following which the ties are displaced relative to at least one of the end disposed supports in order to cause the elongated members to inter-extend in scissor-like fashion in order to tighten the brace against the bone and to apply a preferred degree of compressive and immobilizing force around the damaged exterior bone.

Abstract: In accordance with certain embodiments of the present disclosure, a process of forming a prosthetic device is provided. The process includes forming a dispersion of polymeric nanofibers, a fiberizing polymer, and a solvent, the dispersion having a viscosity of at least about 50,000 cPs. A tubular frame is positioned over a tubular polymeric structure. Nanofibers from the dispersion are electrospun onto the tubular frame to form a prosthetic device. The prosthetic device is heated.

Abstract: An artificial heart valve consists of two or more valve members (10, 20) stacked one upon the other in a housing (40) and having blood flow passages (13, 23) that can be aligned with each other in order to open the valve and allow blood flow through the valve and that can be disaligned to close the valve. The valve members are maintained in continuous rotation and the alignment and disalignment of the valve members is achieved by slowing down and reaccelerating one or more of the valve members using a drive (18, 28) appropriately controlled by a control unit (C).

Abstract: A venous valve with a frame and a cover on the frame for unidirectional flow of a liquid through the valve.

Abstract: A system and method for correcting misshaped ears using a molding device having one or more braces supporting a scaphal mold. The one or more braces and the scaphal mold are adapted to retain the helix and the helical rim of a misshaped ear within a space defined between the one or more braces and the scaphal mold, and to maintain a substantially correct anatomical shape of the helix and the helical rim.

Abstract: A modular elbow prosthesis is disclosed, as well as a surgical approach and implantation technique, for using the prosthesis. The system is the first and only to allow for a, Biomechanically Anatomical, Nonconstrained, Compartmental (BANC) Elbow Arthroplasty. The modularity of the system allows it to be implanted as an unicompartmental or partial elbow replacement or a total elbow replacement. The modular elbow prosthesis for partial elbow replacement includes a cylindrical medial humeral component, a polyethylene ring thereon, and a semicircular medial ulnar component which mates with the polyethylene ring. Additionally, for total elbow replacement, the modular elbow prosthesis also includes a circular lateral humeral component, a polyethylene ring thereon, a semicircular lateral ulnar component, and a radial component. Implantation of the prosthesis is through a minimally invasive medial surgical approach with the aid of precision biomechanical guides.

Abstract: Prosthetic valve devices for implantation in body vessels are provided. The prosthetic valve device includes at least one flexible member that permits fluid flow in a first direction and substantially prevents fluid flow in a second. The valve device also includes an inflatable chamber at least partially attached to the flexible member. The inflatable chamber is adapted to receive inflating media and is adapted to contact the body vessel. A delivery system is also provided that includes a valve device and a delivery apparatus. The delivery apparatus includes a member adapted for filling the chamber of the valve device with inflating media. A related method of making the valve device is also provided.

Abstract: A prosthetic valve in the form of a flap valve which includes one or more flaps arranged to allow movement of liquid through the valve only in one direction, in which the or each flap is made of a flexible open work structure of a medically acceptable metal such as titanium or a titanium alloy.

Abstract: A drug-eluting stent, comprising a base body that is made of an implant material, the base body being partially or entirely covered on the abluminal side with an active ingredient-releasing coating that comprises or is made of a polymer and an active ingredient having an antiproliferative effect, characterized in that the stent's luminal surface and the abluminal surface carrying the active ingredient-releasing coating are covered by a biocorrodible protective layer in a form-fitting manner.

Abstract: A system for modifying a talocalcaneal spatial relationship in a foot in a body, including a subtalar spacer having an articulating surface and implanted in the sinus tarsi of the foot and a fastener that fastens the subtalar spacer to a bone surface in the foot, in which the articulating surface of the subtalar spacer directs relative movement between the calcaneus and the talus of the foot.

Abstract: The present disclosure relates to prosthetic knee implants (100), components (101,102,103,104,105) of prosthetic knee implants, and methods of fixating the components to one another and, especially fixation of the implants to bone.

Abstract: A stent graft is provided which has two stent sections having different functions on, for example, a tubular graft. One stent section preferably comprises a plurality of circumferential reinforcing hoops and the other a Z-stent. The two sections are preferably separated by a spacer section and the tubular graft preferably increases in diameter from the Z-stent section to the hooped section. This enables the stent graft to be compressed radially so that it can be inserted in a catheter for later delivery to a body lumen.

Abstract: A helical stent includes a central segment having a first tubular waveform and a first end segment having a second tubular waveform. The waveforms are defined by a plurality of struts and a plurality of crowns connecting adjacent struts together. The struts of the second tubular waveform have different lengths such that second tubular waveform includes a plurality of amplitudes. The second tubular waveform comprises a complete turn around a longitudinal axis of the stent. A first connector connects together the first tubular waveform first end, the second tubular waveform first end, and the second tubular waveform second end. Due to the configuration of the second tubular waveform of the first end segment, the stent end at the first end segment is substantially orthogonal to the longitudinal axis of the stent. A second end segment similar to the first end segment can be connected to a second end of the first tubular waveform.

Abstract: A prosthetic heart valve comprises a biological tissue valve and a collapsible and expandable support frame comprising a longitudinal axis. The frame comprises an outflow circumferential structure defining an outflow end of the frame and defining a similar row of expandable cells, and a circumferential undulating strut structure spaced apart from the outflow circumferential structure. The frame also comprises three struts longitudinally aligned with the longitudinal axis, configured to facilitate mounting the biological tissue valve to the frame, and interconnecting the outflow circumferential structure to the circumferential undulating structure. Each strut comprises a first end terminating at a respective junction between two adjacent expandable cells of the outflow circumferential structure, and a second end terminating at the circumferential undulating strut structure.

Abstract: In accordance with certain embodiments of the present disclosure, a process of forming a prosthetic device is provided. The process includes forming a dispersion of polymeric nanofibers, a fiberizing polymer, and a solvent, the dispersion having a viscosity of at least about 50,000 cPs. A tubular frame is positioned over a tubular polymeric structure. Nanofibers from the dispersion are electrospun onto the tubular frame to form a prosthetic device. The prosthetic device is heated.

Abstract: Biomedical valve devices, support frames for use in such devices, methods of making such devices, and methods of treating animals, including humans, for valve-related conditions are described. The biomedical valve devices can includes a native tissue valve attached to a support frame or a tissue attached to a support frame in a manner to form a valve. The tissue valve or tissue can be autogenous to the animal being treated.