Abstract: An implantable prosthetic valve can include an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. A leaflet structure can be positioned within the frame and secured thereto. An annular sealing member can be positioned around an outer surface of the frame, wherein the sealing member has a periodic, undulating shape. An outer skirt can be positioned around an outer surface of the sealing member and secured to the frame.

Abstract: A method for delivering a heart valve prosthesis to a native valve annulus comprises expanding an expandable frame at the native valve annulus and positioning a replacement heart valve within the expandable frame. The expandable frame preferably includes a first anchoring portion that is positioned on a first side of the native valve annulus and a second anchoring portion that is positioned on a second side of the native valve annulus. The first anchoring portion engages tissue on the first side of the native valve annulus and the second anchoring portion engages tissue on the second side of the native valve annulus for securing the expandable frame to the native valve annulus. The replacement heart valve comprises a plurality of leaflets for replacing the function of the native valve.

Abstract: A device for regulating blood pressure between a patient's left atrium and right atrium comprises an hourglass-shaped stent comprising a neck region and first and second flared end regions, the neck region disposed between the first and second end regions and configured to engage the fossa ovalis of the patient's atrial septum, and a drug-eluting biodegradable material that biodegrades over time to release a drug that limits tissue overgrowth. The inventive device also may include a biodegradable material that biodegrades to offset flow changes caused by tissue overgrowth. The inventive device may reduce left atrial pressure and left ventricular end diastolic pressure, and may increase cardiac output, increase ejection fraction, relieve pulmonary congestion, and lower pulmonary artery pressure, among other benefits.

Abstract: Provided herein is a mandrel for use in electrospinning prosthetic valve devices. Also provided are prosthetic valve devices for implantation in an animal or a human. Methods of making and using the valve devices are also provided herein.

Abstract: The present disclosure relates generally to apparatuses and methods for delivering an occlusion device to a paravalvular leak. In some embodiments, a paravalvular occlusion apparatus includes a catheter having main body including a proximal end and a distal end, a visualization element disposed in the distal end of the main body, and a working channel extending from the distal end of the main body. The catheter further includes an elongate shaft extendable from the working channel, wherein an occlusion device is coupled to the elongate shaft. In some embodiments, an occlusion device includes a leading end including a first section, and a trailing end opposite the leading end, the trailing end including a second section. The first section and the second section of the occlusion device are operable to be positioned along a perimeter of a prosthetic valve for blocking the paravalvular leak.

Abstract: The invention is a cardiac implant, and associated methods therefore, configured to repair and/or replace a native heart valve, and having a support frame configured to be reshaped into an expanded/changed form in order to receive and/or support an expandable prosthetic heart valve therein. The implant may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace/repair a native valve (or other prosthetic heart valve), but to assume a generally non-rigid and/or expanded/expandable form when subjected to an outward force such as that provided by a dilation balloon. The implant may be configured to have a generally D-shaped configuration when initially implanted, but to assume a generally circular form when subjected to an outward force such as that provided by a dilation balloon.

Abstract: An artificial valve (5; 10; 20; 30; 50) for implantation in a body, in or adjacent to a blood vessel, comprising a casing (12; 37; 61) and an opening and closing mechanism, at least part of said mechanism being a moving part (11; 21, 22; 31, 32, 33; 51) adapted to make an opening and a closing movement to assume an open and a closed position for opening and closing, of the blood through said blood vessel, and positions between said open and closed positions, said closing movement of the moving part (11; 21, 22; 31, 32, 33; 51) being initiated and carried out when a threshold value is reached by a parameter of the mammal or of a device (8) used by the mammal. The opening and closing mechanism is arranged to cause the moving part (51) to its closing movement by means of giving the moving part kinetic energy in a plurality of steps.

Abstract: An endovascular graft including a stent graft and a surgical graft is provided. The stent graft can include an elongated body having a collapsed and expanded configuration and include a frame structure covered by a compression sleeve that retains the elongated body in the collapsed configuration until deployment of the stent graft. The endovascular graft can include a first cuff member sized and dimensioned to extend into a lumen of an aortic arch branch vessel when the endovascular graft is implanted in a subject. The frame structure can include a backstop sized and dimensioned to extend into the first cuff member when the endovascular graft is implanted in the subject. The surgical graft can be partially attached to the stent graft at a proximal end portion thereof.

Abstract: Prosthetic heart valves are described. Prosthetic heart valves can include radially expandable and compressible inner and outer metal frames. The inner frame can be disposed within a lumen of the outer frame and can be coupled to the outer frame. An outflow end of the inner frame can be coupled to and/or located at an outflow end of the outer frame. An end portion of the inner frame can be spaced radially inwardly from an inner surface of the outer frame, such that a radial gap exists between the inner surface of the outer frame and an outer surface of the inner frame. Prosthetic heart valves can further include a plurality of leaflets disposed within and supported by the inner frame, such as by commissure posts of the inner frame.

Abstract: A high efficiency cardiac support system is suitable for chronic use in treating heart failure, wherein the system includes an implantable rotary blood pump, an implantable power module, a wireless power transfer subsystem, a patient monitor, and a programmer. In a cardiac support system, the cumulative efficiencies of the components of the system are capable of providing therapeutically effective blood flow for a typical day of awake hours using the energy from a single wireless recharge of an implanted rechargeable energy source. Moreover, the implantable rechargeable energy source may be recharged during a normal sleep period of 8 hours or less. The system may provide full or partial cardiac support without the need for external wearable batteries, controllers, or cables.

Abstract: An implant is disclosed for the first metatarsophalangeal joint between the proximal phalange and the first metatarsal, the phalange moving in a sagittal plane perpendicular to a transverse plane. The implant includes a metatarsal component for securing against the distal end of the first metatarsal, the metatarsal component having an interfacing surface with a plurality of ridges and valleys. The implant further includes a phalangeal component for securing against the proximal end of the proximal phalange, the phalangeal component having an interfacing surface with a plurality of ridges and valleys, wherein the ridges of the interfacing surface of the metatarsal component are received by the valleys of the interfacing surface of the phalangeal component to provide for a full range of motion in the sagittal plane but impede motion in the transverse plane.

Abstract: A prosthetic heart valve, and associated methods therefore, 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. 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 non-rigid and/or expanded/expandable form when subjected to an outward force such as that provided by a dilation balloon.

Abstract: An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration includes an annular frame having an inflow end, an outflow end, and a longitudinal axis. A leaflet structure is positioned within the frame and secured thereto, and a sealing element is secured to the frame. The sealing element includes a first woven portion extending circumferentially around the frame. The first woven portion includes a plurality of interwoven filaments. The sealing element further includes a second woven portion extending circumferentially around the frame and spaced apart from the first woven portion along the longitudinal axis of the frame. At least a portion of the filaments exit the weave of the first woven portion and form loops extending radially outwardly from the frame.

Abstract: An intra-vascular aneurysm-treatment stent and a method for lowering pressure within an aneurysm bubble in a blood vessel. A stent coil is insertable into a blood vessel, the coil made of a material sufficiently flexible to move around curves, loops, and corners in the blood vessel. The stent coil is positioned in the blood vessel with selected stent coil portions proximate an opening into either a saccular aneurysm or a fusiform aneurysm. Blood in the lumen of the blood vessel flows past the leading edges and both over the outer surfaces, and under the inner surfaces. A portion of the blood inside the aneurysm becomes entrained with the blood flowing over the outer surfaces. At the trailing edges, the converging blood flows create eddies.

Abstract: This disclosure is related to devices and related methods for isolating a treatment region in a human body from fluid pressure. In various embodiments, an implantable device for isolating a treatment region in a human body from fluid pressure comprises a first elongated segment, and a second elongated segment, and one or more branch segments in fluid communication with one of the first elongated segment and the second elongated segment. The elongated segments have a combined cross section that is substantially conformable to an intraluminal cross section of a body lumen into which they are implanted. A method of installing an implantable medical device into the body of a patient comprises deploying a first elongated segment, deploying a second elongated segment, and deploying one or more branch segments in a target region of a vasculature.

Abstract: A surgical implant assembly includes a surgical implant, a bone plate, and fixation devices. The surgical implant includes a top surface, a bottom surface disposed in opposed relation relative to the top surface, first and second surfaces interconnecting the top and bottom surfaces, and a front surface. First ends of the first and second side surfaces define a back surface extending across a first end of the surgical implant, and the front surface extends across a second end of the surgical implant and interconnects second ends of the first and second side surfaces. At least one cavity is defined in the surgical implant. The bone plate includes an elongate body extending between first and second end portions. The elongate body is positionable adjacent the front surface of the surgical implant. The fixation devices are configured to secure the surgical implant or the bone plate to osseous tissue.

Abstract: A device for measuring heart valve for sizing a heart valve reinforcement ring, includes a first handle having a first shaft an outer ring coupled to the first shaft, wherein the outer ring has an inner surface; and an inner ring having an outer surface, wherein the inner ring is removably couplable to the outer ring. The inner surface of the outer ring and the outer surface of the inner ring further have reciprocal mating surfaces configured and arranged to grip sutures therebetween when coupled together. The device may further have a second handle with a second shaft connected to the inner ring. Alternatively, the first handle may have a second shaft that is connected to a second outer ring.

Abstract: A prosthetic valve has fluoroscopic properties for precise placement of the prosthetic valve in a human stenosed aortic orifice. The prosthetic valve comprises a support frame having a distal and a proximal end, and three adjacently placed rows of hexagonal cells (namely an upper, middle and a lower row). The upper row occupies 50-55% of total length of the support frame. The support frame of the prosthetic valve under fluoroscopy comprises a plurality of light bands and dark bands alternating with each other along the length of the support frame. Further, a second dark band from the distal end of the support frame is bisected by aortic annular plane on placement in orthotopic position of a human stenosed aortic orifice. The prosthetic valve offers advantages such as minimal protrusion in left ventricle and minimal obstruction of prosthetic valve to ostia of coronary arteries.

Abstract: A prosthetic heart valve can include a frame, a valve component, and a sealing member. The frame can have an inflow end portion, an outflow end portion, an intermediate portion disposed between the inflow and outflow end portions, and a plurality of struts. The frame can be radially compressible and expandable between a radially-compressed configuration and a radially-expanded configuration. The valve component can be disposed within and coupled to the frame and have a plurality of leaflets. The sealing member can have a plurality of ribs and a plurality of drapes. The ribs can be coupled to and extend radially outwardly from the frame when the frame is in the radially-expanded configuration. The drapes can be coupled to and extend radially between the frame and the ribs. The sealing member can be configured to reduce or prevent perivalvular leakage around the prosthetic heart valve.

Abstract: A transcatheter valve prosthesis includes an expandable tubular stent, a prosthetic valve within the stent, and an anti-paravalvular leakage component coupled to and encircling the tubular stent. The anti-paravalvular leakage component includes a radially-compressible annular scaffold, which is a sinusoidal patterned ring of self-expanding material, and an impermeable membrane extending over the annular scaffold. The anti-paravalvular leakage component has an expanded configuration in which at least segments of the annular scaffold curve radially away from the tubular stent. Alternatively, the anti-paravalvular leakage component includes a plurality of self-expanding segments and an annular sealing element coupled to inner surfaces of the segments. The anti-paravalvular leakage component has an expanded configuration in which the segments curve radially away from the tubular stent and the annular sealing element is positioned between an outer surface of the tubular stent and inner surfaces of the segments.