Abstract: This application relates to a system, apparatus, and methods for renal dialysis training the patients, providers, and caretakers without harming or injuring an actual patient. The renal dialysis may be hemodialysis, peritoneal dialysis, or both. The system comprises at least one closed-loop apparatus with at least one of the following—artificial blood, cannulatable vascular system, heart, peritoneal membrane and cavity, vascular valves, artificial skin, and/or other artificial organs set inside a mannequin, humanoid, or any human-like machine. The artificial organ in the mannequin can be accessed through an opening in the chest, arm, abdominal cavity, thigh, groin, neck, and any combination thereof. The renal dialysis may be through catheter access, arterio-venous graft access, and peritoneal catheter access.

Abstract: In one embodiment, a prosthetic valve can comprise a radially expandable and compressible frame, which can include a plurality of struts which are pivotally joined together without requiring individual rivets. In some embodiments, the struts are interwoven, and can be joined using integral hinges formed in the struts, such as by performing alternate cuts on the struts, bending the struts to form stopper tabs adjacent to joints and/or drilling holes in the struts to facilitate interconnecting struts at joints, or otherwise forming integral hinges and corresponding holes at junction points between the struts. In another embodiment, the frame comprises a plurality of inner struts and outer struts which are connected by a plurality of chains of interconnected rivets, avoiding the need to provide individual rivets at each junction between struts. In still another embodiment, separate hinges or flanged rivets are provided to interconnect the struts.

Abstract: A prosthetic heart valve implant is provided including a frame shaped so as to define upstream and downstream openings at upstream and downstream ends of the frame, respectively, when the implant is in an expanded state for implantation at a heart native valve. A sheet is coupled to the frame. When the implant is in the expanded state, the frame is shaped so as to define the following longitudinal portions arranged along a central longitudinal axis of the prosthetic heart valve implant: a substantially cylindrical mid portion having a diameter greater than respective diameters of the upstream and the downstream ends of the frame; an upstream portion, extending upstream and radially inward from the mid portion; and a downstream portion, extending downstream and radially inward from the mid portion. Other embodiments are also described.

Abstract: A prosthetic heart valve includes a frame, a valve component, and an actuation mechanism. The frame has a plurality of struts interconnected by a plurality of joints and is movable between expanded and compressed configurations. The valve component is inside the frame and has a plurality of leaflets. The actuation mechanism has a first expansion element coupled to the frame at a first location and a second expansion element coupled to the frame at a second location. The actuation mechanism is configured such that moving the first expansion element and the second expansion element toward each other in a first direction results in the frame moving from the compressed configuration to the expanded configuration, and such that moving the first expansion element and the second expansion element away from each other in a second direction results in the frame moving from the expanded configuration to the compressed configuration.

Abstract: Described is a prosthetic valve, comprising: an expandable stent including an inner lumen and having a first and a second end; and a spring attached to the first end of the expandable stent; wherein the expandable stent and the spring can expand radially to a desired diametric configuration in order to anchor the prosthetic valve at an implantation position in a body lumen. Related systems and methods.

Abstract: An implantable prosthetic valve has an upper frame section and a lower frame section. The upper frame section has a plurality of struts and a first leaflet receiving surface at a lower portion of the upper frame section. The lower frame section has a second leaflet receiving surface at an upper portion of the lower frame section. An edge of a flexible leaflet is disposed between the first and second leaflet receiving surfaces to attach the leaflet to the upper and lower frame sections.

Abstract: A stented valve including a generally tubular stent structure that has a longitudinal axis, first and second opposite ends, a plurality of commissure support structures spaced from the first and second ends and extending generally parallel to the longitudinal axis, at least one structural wire positioned between each two adjacent commissure support structures, and at least one wing portion extending from two adjacent commissure support structures and toward one of the first and second ends of the stent structure. The stented valve further includes a valve structure attached within the generally tubular stent structure to the commissure support structures.

Abstract: A prosthetic heart valve comprises a radially collapsible and expandable annular frame and a leaflet structure comprising three leaflets. Each leaflet has an upper edge portion, a curved lower edge portion and two side flaps, wherein each side flap is connected to an adjacent side flap of another leaflet to form commissures of the leaflet structure, with each commissure being attached to the frame. An annular inner sleeve comprises three U-shaped portions positioned along the curved lower edge portions of the leaflets. An annular outer sleeve extends around are outer surface of the frame, wherein the outer sleeve is made of pericardium. The frame is made of Nitinol and the prosthetic valve can be radially crimped to a radially collapsed configuration inside a sheath for delivery into a patient's body and self-expand to a radially expanded configuration when released from the sheath inside the patient's body.

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.

Abstract: Aspects of the present invention provide apparatuses and methods for closing an apical hole in a heart of a subject, including a hole-closure device that includes a tissue-attachment portion configured to attach to cardiac tissue around the apical hole, and a collapsible portion coupled to the tissue-attachment portion and configured to close the hole by collapsing inwardly inside the apical hole.

Abstract: A prosthetic heart valve is designed to be circumferentially collapsible for less invasive delivery into the patient. At the implant site the valve re-expands to a larger circumferential size, i.e., the size that it has for operation as a replacement for one of the patient's native heart valves. The valve includes structures that, at the implant site, extend radially outwardly to engage tissue structures above and below the native heart valve annulus. These radially outwardly extending structures clamp the native tissue between them and thereby help to anchor the prosthetic valve at the desired location in the patient.

Abstract: Various embodiments of a ventricular assist system and a method of using such system are disclosed. The system includes a pump adapted to be connected to a heart of a patient, an outflow cannula including a first end adapted to be connected to an outlet of the pump and a second end adapted to be connected to an artery of the patient, and an electrode disposed on an outer surface of the outflow cannula and adapted to be disposed adjacent to an exterior wall of the heart. The system further includes a controller electrically connected to the pump and the electrode, where the controller is adapted to provide a pacing signal to the electrode.

Abstract: A prosthetic valve may be formed to direct flow out of the outflow orifice toward a posterior portion of a heart wall. The prosthetic valve includes an expandable frame which may be covered with a cover that is suturelessly attached to the frame. The prosthetic valve may also include an outflow orifice size which is controlled. Methods of using these devices are also disclosed.

Abstract: A medical implant may include an expandable anchor member having a lumen extending through the expandable anchor member from an inflow end to an outflow end; a plurality of valve leaflets disposed within the lumen extending through the expandable anchor member; a seal member disposed adjacent an exterior of the expandable anchor member; and a porous material extending from the seal member to the plurality of valve leaflets.

Abstract: An implantable valve prosthesis for preventing blood reflux from a cardiac atrium into a vein opening into the atrium, with a generally tubular stent (2), also a flexible tube (3) that can be closed by collapsing the tube (3) and which is arranged at least in a partial area of a second end section (9) of the stent (2) on the outer peripheral surface. The second end opening (11) of the flexible tube (3) is open in the pressureless state. As a result of this valve design, during a physiological flow out of the pulmonary vein in the direction of the left atrium or out of the caval vein in the direction of the right atrium, there is no rise or an only insubstantial rise in the resistance to flow.

Abstract: Support frames and medical devices are described. An example medical device comprises an expandable support frame with first and second leaflets attached to the support frame. Each of the first and second leaflets defines a domed radius that is equal to or less than the radius of the expandable support frame when the expandable support frame is in an expanded configuration and the leaflets are subjected to fluid pressure sufficient to affect closure of the valve orifice.

Abstract: A medical device including a valve member with an elongate tubular portion with at least one aperture disposed in a sidewall at a location between the proximal and distal ends, and a plurality of leaflets; a first endovascular graft coupled to the valve member; and a second endovascular graft coupled to the first endovascular graft; and an expandable anchor member coupled to the second endovascular graft.

Abstract: Prosthetic valves are provided with a leaflet assembly having at least one leaflet attached to a supporting element, which leaflet has a free margin that can move between a first position wherein the free margin is flexed away from a closure surface to allow body fluid to flow through the valve, and a second position wherein the free margin abuts the closure surface to close the valve, and wherein the leaflet, without pulsatile load on the valve, can form a coaptation height H of more than 0.1 mm along the length of the free margin. Such prosthetic valve provides good performance during prolonged time, and can be made using various materials for the leaflets.

Abstract: This invention relates to the design and function of a retrieval device for a prosthetic heart valve for re-positioning or removal of a previously implanted valve prosthesis from a beating heart without extracorporeal circulation using a transcatheter retrieval system.

Abstract: A prosthetic mitral valve may be anchored in a native mitral valve. The prosthetic mitral valve preferably has a large anterior prosthetic leaflet that spans the entire width of the native anterior leaflet and the anterior prosthetic leaflet moves away from left ventricular outflow tract during systole to create a clear unobstructed outflow path.

Abstract: The present technology relates to aneurysm devices with additional anchoring mechanisms, and associated systems and methods. The aneurysm device is endovascularly deliverable to a site proximate an aneurysm near a parent artery with bifurcating branches. The device can include a closure structure comprising a distal-facing aspect configured to at least partially occlude the aneurysm. The closure structure can be formed from a generally flat pattern and is transformable between a compressed configuration and a deployed configuration. The device can also have one or more lodging elements which fold to form loop elements configured for anchoring within at least one of the bifurcating branches. The struts of the lodging elements can include hinge points which bias the folding of the lodging elements. The devices further include a supplemental stabilizer connected to the closure structure and configured to reside in the parent artery.

Abstract: A prosthetic valve for implantation within a native mitral valve may be provided. The prosthetic valve may include an annular valve body, a plurality of atrial anchoring arms configured to extend radially outward from the annular valve body, and a plurality of ventricular anchoring legs configured to extend radially outward from the annular valve body. The arms may be configured to engage an atrial portion of the native mitral valve and the ventricular anchoring legs may be configured to engage a ventricular portion of the native mitral valve. The atrial anchoring arms and the ventricular anchoring legs may be positioned relative to each other such that when the atrial anchoring arms and ventricular anchoring legs engage the native mitral valve, a volume between the atrial anchoring arms and ventricular anchoring legs is configured to be substantially filled with tissue.

Abstract: Devices and methods for treating heart disease by increasing the pulmonary vascular compliance and thereby decreasing the right ventricular afterload are disclosed. Devices may include a means for reducing the cross-sectional area of the pulmonary artery during diastole and allowing the cross-sectional area to increase during systole.

Abstract: Devices and methods for treating tricuspid regurgitation (TR) are provided. A clasp or clamp is used to anchor a TR-treatment device to an existing lead of a pacemaker or an implantable cardioverter defibrillator (ICD) that passes through the tricuspid valve. The TR-treatment device can be a balloon occluder that is adjustable by filling or withdrawing filler material from the occluder through a proximal port implanted in the skin of the patient.

Abstract: A two-stage or component-based valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. If desired, the native leaflets may remain and the stent may be used to hold the native valve open. In this case, the stent may be balloon expandable and configured to resist the powerful recoil force of the native leaflets. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be a non-expandable type, or may be expandable from a compressed state to an expanded state.

Abstract: The present invention provides an apparatus for endovascularly replacing a patient's heart valve. In some embodiments, the apparatus includes an expandable anchor supporting a replacement valve, the anchor and replacement valve being adapted for percutaneous delivery and deployment to replace the patient's heart valve, the anchor having a braid having atraumatic grasping elements adapted to grasp tissue in a vicinity of the patient's heart valve.

Abstract: A prosthetic heart valve includes a frame, a valvular structure coupled to the frame, and a sealing member coupled to the frame. The frame has inflow and outflow ends and a lumen extending therebetween. The frame includes struts that form cells, and the cells are arranged in three rows. The frame is radially expandable from a collapsed state to an expanded state. The valvular structure includes a plurality of leaflets configured to allow blood flow through the lumen of the frame from the inflow end to the outflow end and to block blood flow through the lumen of the frame from the outflow end to the inflow end. The sealing skirt extends from an intermediate location of the frame disposed between the inflow and outflow ends to the inflow end of the frame. The sealing skirt covers two rows of cells to block blood flow through the cells.

Abstract: A frame for an implantable medical device, comprising: a first member, comprising a plurality of struts defining a plurality of cells, wherein the first member is annular and defines a longitudinal direction which is parallel to the axis of the first member, a radial direction, and a circumferential direction; a second member, comprising a plurality of struts and coupled to the first member at circumferentially distributed locations; wherein the second member overlaps a first end portion of the first member and extends beyond the first end portion of the first member.

Abstract: The present invention provides devices for treating functional mitral regurgitation and methods of use thereof. The devices translocate a subject's mitral valve in an apical direction. The devices thereby treat mitral regurgitation while preserving a subject's original mitral valve and chordae tendinae.

Abstract: A frame assembly (222) includes a tubular portion (32) that defines a lumen along an axis; a plurality of arms (46) coupled to the tubular portion at a first axial level, each of the arms extending radially outward from the tubular portion to a respective arm-tip; and a plurality of ventricular legs (50) that are coupled to the tubular portion at a second axial level, and that extend radially outward from the tubular portion. A first sheet (440) has a greater perimeter (446), and a smaller perimeter (448) that defines an opening. The first sheet is stitched onto the plurality of arms, with the opening aligned with the lumen. Subsequently, an outer perimeter (454) of a second sheet (450) is stitched to the greater perimeter of the first sheet. Subsequently, the second sheet is everted by passing an inner perimeter (452) of the second sheet around the arm-tips.

Abstract: A replacement heart valve system may include a delivery sheath and a replacement heart valve. The replacement heart valve may include a mesh anchor member disposed within the delivery sheath in an elongated delivery configuration, the mesh anchor member being expandable to a deployed configuration when unconstrained by the delivery sheath. The mesh anchor member may include an upstream chamber, a downstream chamber, and a tubular middle portion extending between the upstream chamber and the downstream chamber. The replacement heart valve may include a diaphragm disposed within the downstream chamber of the mesh anchor member, wherein the diaphragm is configured to selectively prevent fluid flow through the replacement heart valve.

Abstract: An embolic material blocking catheter includes a handle assembly, an elongated element having a lumen, and a deployable embolic material blocking element. The embolic material blocking catheter is configured to accommodate insertion of a treatment catheter into the lumen to position a treatment device distal to the embolic material blocking element for administering a treatment at a treatment site and/or convey embolic material blocked by the embolic material blocking element for extraction from the patient.

Abstract: This invention relates to the design and function of a compressible valve replacement prosthesis which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed focuses on the deployment of a device via a minimally invasive fashion and by way of example considers a minimally invasive surgical procedure preferably utilizing the intercostal or subxyphoid space for valve introduction. In order to accomplish this, the valve is formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the annulus of a target valve such as a mitral valve or tricuspid valve.

Abstract: A prosthetic valve comprising a conical shaped ribbon structure comprising an extracellular matrix (ECM) composition. The ribbon structure comprises a plurality of elongated ribbon members that are positioned proximate each other in a joined relationship, wherein the ribbon members are positioned adjacent each other and form a plurality of fluid flow modulating regions that open when fluid flow through the valve exhibits a negative flow pressure and open when fluid flow through the valve exhibits a positive flow pressure.

Abstract: A prosthetic valve comprising a conical shaped ribbon structure comprising a polymeric composition. The ribbon structure comprises a plurality of elongated ribbon members that are positioned proximate each other in a joined relationship, wherein the ribbon members are positioned adjacent each other and form a plurality of fluid flow modulating regions that open when fluid flow through the valve exhibits a negative flow pressure and open when fluid flow through the valve exhibits a positive flow pressure.

Abstract: A method of treating a defective heart valve includes inserting a delivery catheter through a small incision in a patient's groin, wherein the delivery catheter has a prosthetic device positioned along a distal end. The prosthetic device includes an insert member and an anchoring member. The insert member is positioned between the native heart valve and is allowed to self-expand. The anchoring member is preferably a stent connected to the insert member by at least one elongate member. The stent is deployed within an adjacent blood vessel for anchoring the insert member between the native leaflets. After deployment of the prosthetic device, the native leaflets of the heart valve form a tight seal against the insert member for preventing regurgitation through the native heart valve during ventricular systole.

Abstract: A mitral valve prosthesis includes an hourglass shaped inner frame and a bulbous outer frame. A valve body having a plurality of leaflets is positioned within an interior region of the inner frame. The leaflets are shaped to substantially conform to an interior surface of the inner frame when the leaflets are in an open position. As a result, the gap between the leaflets and the inner frame is decreased, thereby reducing the likelihood of thrombus formation. Ventricular anchors are preferably provided along a distal end of the inner frame. The anchors extend proximally for placement behind native mitral valve leaflets. A fabric skirt may extend along an inner or outer surface of the outer frame. In preferred embodiments, the fabric skirt extends distally beyond a distal end of the outer frame and is adapted for forming a seal along the mitral valve annulus.

Abstract: An implantable endoluminal prosthesis for replacing a damaged aortic valve is provided. In one embodiment, the prosthesis includes a balloon-expandable stent, a tubular conduit that extends into the ascending aorta, and a self-expanding stent. The tubular conduit extends across the balloon-expandable stent. The tubular conduit includes an artificial valve. The self-expanding stent extends across the tubular conduit into the ascending aorta. The balloon-expandable stent, the tubular conduit, and the self-expanding stent are coupled to provide unidirectional flow of fluid into the aorta and further into the coronary arteries. Also provided is a method for implanting the endoluminal prosthesis.

Abstract: A prosthetic heart valve includes a frame, a valvular structure coupled to the frame, and a sealing member coupled to the frame. The frame has inflow and outflow ends and a lumen extending therebetween. The frame includes struts that form cells, and the cells are arranged in three rows. The frame is radially expandable from a collapsed state to an expanded state. The valvular structure includes a plurality of leaflets configured to allow blood flow through the lumen of the frame from the inflow end to the outflow end and to block blood flow through the lumen of the frame from the outflow end to the inflow end. The sealing skirt extends from an intermediate location of the frame disposed between the inflow and outflow ends to the inflow end of the frame. The sealing skirt covers two rows of cells to block blood flow through the cells.

Abstract: A prosthetic vascular valve includes one or more continuous loops of frame material or one or more strands of material that do not form a continuous loop. The frame includes a plurality of longitudinal portions, wherein a membrane is attached to at least one of the longitudinal portions, and wherein the membrane is configured to open and close. During implantation, the frame engages the inner surface of the vein wall and is biased against the vein wall to remain stationary. In use, blood flows from an upstream end to a downstream end, wherein the membrane mitigates regurgitation of the blood as the blood is conveyed through the subject vein.

Abstract: A venous valve prosthesis includes a frame and a prosthetic valve coupled to the frame. With the venous valve prosthesis implanted in a vein, the prosthetic valve includes a closed configuration wherein an outer surface of the prosthetic valve is in contact with a wall of the vein around a circumference of the prosthetic valve to prevent blood from flowing past the prosthetic valve between the wall of the vein and the outer surface of the prosthetic valve. The prosthetic valve is configured to move to an open configuration such that at least a portion of an outer wall of the prosthetic valve partially collapses away from the wall of the vein in response to antegrade blood flow through the vein to enable blood flow between the outer surface of the prosthetic valve and the wall of the vein.

Abstract: A replacement heart valve device is disclosed. In some embodiments, the device includes a frame coupled to one or more leaflets that are moveable between open and closed configurations. In some embodiments, the frame comprises at least two frame sections that join at a pair of commissural posts. In some embodiments, the device may be geometrically accommodating to adapt to different vasculature shapes and sizes and/or to be able to change size while implanted within a growing patient.

Abstract: A prosthetic heart valve includes a collapsible and expandable annular frame. The frame includes a plurality of rows of hexagonal cells. Each of the hexagonal cells is defined by six struts, including: two opposing side struts extending parallel to each other, a first pair of angled struts extending from respective first ends of the side struts and converging to intersect with each other, and a second pair of angled struts extending from respective second ends of the side struts and converging to intersect with each other. The prosthetic heart valve can also include a valvular structure with a plurality of leaflets. The prosthetic heart valve can further include a sealing member.

Abstract: Venous endoluminal devices, in particular for the treatment of defects of the veins, are provided with a substantially tubular body which defines an inner lumen and support modules oriented longitudinally and joined, in a distal direction, by distal bridges and in a proximal direction, by proximal bridges. Each support module includes a distal section, extending in a distal direction beyond the distal bridges, wherein the distal section is at least partially projecting in a radial direction, internally in relation to the inner lumen of the body. Methods of treatment using such devices are also provided.

Abstract: A prosthetic valve comprising a conical shaped ribbon structure comprising an extracellular matrix (ECM) composition. The ribbon structure comprises a plurality of elongated ribbon members that are positioned proximate each other in a joined relationship, wherein the ribbon members are positioned adjacent each other and form a plurality of fluid flow modulating regions that open when fluid flow through the valve exhibits a negative flow pressure and open when fluid flow through the valve exhibits a positive flow pressure.

Abstract: The invention relates to a radially expandable stent (1) comprising a plurality of flexibly interconnected meandering ring elements (2, 3) defining a stent (1) having a proximal and a distal end and a longitudinal axis, wherein said ring elements (2, 3) being arranged side by side along the longitudinal axis of the stent and adjoining ring elements (2, 3) being attached to each other through connection elements (4), wherein connection elements (4) are arranged between at least two adjoining ring elements (2, 3), said connection elements each having at least one expandable expansion element with predetermined breaking point (10), wherein the expansion being possible in the longitudinal and/or transverse direction and the predetermined breaking points (10) only disrupting after the expansion element has been overstretched beyond its maximum expansion point.

Abstract: An example medical device is disclosed. An example medical device includes an expandable stent. The stent includes a tubular scaffold formed of one or more interwoven filament. The tubular scaffold includes an inner surface and a flexible valve extending radially inward from the inner surface of the scaffold. Further, the valve is configured to shift between a closed configuration and an open configuration and the one or more filaments of the scaffold bias the valve to the closed configuration while in a nominally deployed state.

Abstract: In an aspect, a device includes a body structure including a core and a sleeve disposed around at least a portion of the core, the core defining a channel through the core extending from a first end of the core to a second end of the core, the sleeve including a flange adjacent the second end of the core; and a deployable portion coupled to the body structure adjacent the first end of the core, the deployable portion having a wired structure transitionable between a retained configuration and a deployed configuration, wherein a top portion of the wired structure extends beyond the first end of the core in a longitudinal direction when the wired structure is in the retained configuration, and wherein first end of the core extends beyond the top portion of the wired structure when the wired structure is in the deployed configuration.

Abstract: Prosthetic mitral valves and their methods of manufacture and use.

Abstract: An implant device (V), such as a heart valve, for implantation in an animal body includes an annular structure and one or more elongated anchoring members deployable to a deployed condition for insertion into an animal body. The anchoring members are retractable from the deployed condition to a rolled up condition wherein the anchoring members protrude radially out from the annular structure of the device (V) to provide anchoring to a body structure (AS) of an animal. In the rolled up condition the anchoring members at least partly protrude axially of the annular structure of the device (V).