274 results about "Prosthetic heart" patented technology

A prosthetic heart valves including an annular frame and one or more detachable outer skirts and methods associated therewith are disclosed. The frame includes a plurality of interconnected struts and one or more outer skirts releasably attached to an exterior surface of the frame. In some examples, an outer skirt is attached to the frame via at least one retaining suture formed by a plurality of stitches looped around a pull suture. Removal of the pull suture from the suture line enables the outer skirt and frame to separate as the stitches are pulled through openings in the outer skirt and remain attached to the frame. Removability of the outer skirt can facilitate improvements in implant and explant procedures of the prosthetic valves, such as, for example, valve-in-valve procedures.

A prosthetic valve includes a radially expandable and compressible frame, a leaflet assembly comprising a plurality of leaflets coupled to the frame, and an outer skirt positioned around an outer surface of the frame. The outer skirt includes a tissue layer and a non-tissue layer. The tissue layer has a fibrous side and a smooth side. The non-tissue layer is coupled to the smooth side of the tissue layer. The outer skirt is positioned so that the fibrous side of the tissue layer faces away from the frame and the non-tissue layer faces towards the frame.

A delivery device for percutaneously delivering a stented prosthetic heart includes a sheath, a handle, and adjustment device including a fine adjustment mechanism, and an outer stability shaft. The sheath defines a lumen and is configured to compressively constrain the stented prosthetic heart valve. The handle is coupled to the proximal portion of the sheath and includes an actuator mechanism coupled to a proximal portion of the sheath that is configured to selectively move the sheath relative to the housing to release the stented prosthetic heat valve. The adjustment device is coupled to the handle and includes an adjustment lumen through which the sheath and the handle slidably extend. The outer stability shaft is coupled to the adjustment device. The fine adjustment mechanism is configured to selectively move the handle and the sheath relative to the adjustment device and the outer stability shaft.

This application relates to prosthetic heart valves. Disclosed are embodiments of a radially collapsible and expandable prosthetic heart valve. The valve frame can have a tapered profile when mounted on a delivery shaft, with a smaller diameter at the inflow end portion than at the outflow end portion. The valve can include generally V-shaped leaflets, reducing the amount of material in the inflow end of the frame. An outer skirt can be secured to the outside of the inflow end portion of the frame, with longitudinal slack when the valve is expanded and lying flat against the frame when the valve is collapsed. An angularly woven inner skirt can be axially elongated with the frame. Side tabs adjacent the leaflets can extend through and be secured to window frame portions of the frame to form commissures. The window frame portions can be recessed radially inward relative to the surrounding frame portions when the valve is crimped on a delivery shaft.

In some examples, a method of manufacturing a prosthetic heart valve includes providing a stent and a valve assembly, the valve assembly including at least one of an inner cuff and an outer cuff, and a plurality of leaflets, sputter coating a layer of one or more target materials onto a surface of at least one component selected from the plurality of leaflets, the inner cuff and the outer cuff, and coupling the valve assembly to the stent.

A prosthetic heart valve for the treatment of structural heart disease wherein the prosthetic heart valve includes an expandable frame that a) has an open cell geometry in the frame of the prosthetic heart valve that can be used to reduce delivery system size, b) has high radial strength, c) has improved restoration of the physiologic EOA, d) has lower recoil, e) has little or no longitudinal foreshortening, f) allows for proper placement of the bioprosthetic valve in relation to the native commissures of the valve, h) has symmetrical and cylindrical expansion of the prosthetic valve resulting in lower rates of leaflet thrombosis and structural valve deterioration, and / or i) prevents allergic response and restenosis associated with nickel content.

A collapsible and expandable prosthetic mitral valve stent is provided with improved recapture into a distal lumen of a delivery sheath. Various embodiments comprise a valve support within the interior of a stent frame and defining a flow channel therethrough, wherein the top or upstream of the valve support comprises a row, or a plurality, of stent cells that are bent radially inward at least partially over the flow channel. Some embodiments may comprise a recapture assist mechanism, such as an open paddle, attached to one or more of the inwardly bent stent cells and adapted to receive and / or engage a wire to aid in positioning, expansion, recapture and / or implanting the device in a patient's heart chamber.

Valve positioning structures for use in a prosthetic heart valve delivery apparatus and associated methods. The delivery apparatus can include a balloon coupled to a distal end portion of a shaft and a valve positioning structure can be disposed around the balloon, and a prosthetic heart valve can be crimped around the balloon and the valve positioning structure. The valve positioning structure can include a support structure, such as a frame or a braided wire mesh, which can be coated with a polymeric coating to protect the balloon and the prosthetic valve. In some examples, the polymeric coating is an open-cell polymeric coating. In some examples, the polymeric coating is a closed-cell polymeric coating. In some examples, a webbing portion of the closed-cell polymeric coating spanning across the cells of the support structure can be formed while the support structure is in an at least partially expanded state.

Packaging for prosthetic heart valves including an assembly for stabilizing dry prosthetic tissue implants such as heart valves during storage. The packaging assembly includes a primary sterile barrier that permits gas sterilization of the tissue implant, and a secondary sterile barrier that also prevents oxidation of the implant during long-term storage. Tissue heart valves may be placed or suspended within a cavity of an inner rigid tray with a gas-permeable lid sealed thereon, and a cap placed over the cavity to limit movement of the valve therein. The inner tray is placed within an outer sterile barrier, such as another rigid tray or a flexible pouch, and the assembly is then sterilized. The outer sterile barrier may include a double seal so that a first gas-permeable seal can be closed for sterilization, after which a second gas-impermeable seal can be closed to seal out any further oxygen contact with the tissue implant. Alternatively, the inner tray may be placed within a sterile pouch and the assembly gas-sterilized, and then the entire assembly is placed within another pouch that provides an impermeable barrier to the surrounding atmosphere to prevent oxidation of the tissue implant.

The invention relates to a heart valve docking device and a system for treating a native valve of a patient. In various embodiments, the device is configured to repair a native heart valve or to secure a prosthetic heart valve within a native valve of a patient's heart. An embodiment of the apparatus includes at least an upper coil and a lower coil, wherein the apparatus is configured to assume an axially expanded state in which the entire upper coil is positioned on a first side of the lower coil relative to the central axis and an axially compressed state in which at least a portion of the upper coil is positioned on a second side of at least a portion of the lower coil opposite the first side relative to the central axis.

The present invention provides a method for using prostheses, such as replacement heart valves, to be delivered and / or controlled to a desired location within the body. [Solution] A foldable and expandable frame comprising rows of cells may include a plurality of axial connecting portions extending between the top and bottom ends of the cells, each axial connecting portion being shaped to bend to accommodate transient changes in cell height during uneven compression of the replacement heart valve. The frame is advantageous when advancing the replacement heart valve through a funnel-shaped compression tool. The axial connecting portions are sufficiently flexible to accommodate changes in the frame shape during compression, while also being sufficiently resilient to reinforce the structural integrity of the frame in the fully deployed state. The replacement heart valve is preferably a double-frame heart valve, where the axial connecting portions form part of the inner frame, and the outer frame is provided to engage with tissue and form a seal.

A delivery system for delivering a prosthetic valve in a compressed condition over an inner shaft of a catheter. The delivery system includes a tip extending distally from the inner shaft. The tip has a proximal section and an opposite distal section extending to an end of the tip. The proximal section is configured to support an end of the prosthetic valve during loading and delivery of the prosthetic heart valve and includes a first portion, a second portion, and a third portion. The first portion is adjacent the distal section. The second portion is between the first portion and third portion. The third portion is adjacent a proximal end of the tip. An outer diameter of the first portion is greater than an outer diameter of the inner shaft, an outer diameter of the second portion, and an outer diameter of the third portion.

A delivery device for a collapsible prosthetic heart valve includes an inner shaft, an outer shaft, and a distal sheath. The distal sheath may be disposed distal to the outer shaft and about a portion of the inner shaft to form a compartment with the inner shaft. The compartment may be sized to receive the prosthetic heart valve. The inner shaft and the distal sheath may be movable relative to one another. A spine may extend along the outer shaft, the spine biasing the outer shaft so that the outer shaft tends to bend in a pre-determined direction.

A transfemoral delivery system for implanting a replacement heart valve is provided. The replacement heart valve includes an expandable frame and a plurality of distal anchors. The delivery device includes an outer sheath assembly, a mid-shaft assembly, and an inner assembly, wherein the outer sheath assembly and the mid shaft assembly retain the replacement heart valve in a radially compacted state. The outer sheath assembly is retracted relative to the mid-shaft assembly to release the distal anchors while a portion of the replacement heart valve remains retained by the mid shaft assembly. After the distal anchors engage leaflets of the native heart valve, the retained portion of the replacement heart valve is released from the mid-shaft assembly and is allowed to fully expand.

Off-balloon prosthetic valve delivery procedures involving valve positioning structures are disclosed. As one example, a delivery procedure can include crimping a prosthetic valve around a valve positioning structure of a delivery system, wherein the valve positioning structure can be in a first, off-balloon position relative to a balloon of the delivery system, and moving the valve positioning structure in an axial direction to a second, on-balloon position relative to the balloon. The second position can be axially spaced apart from the first position. In the second position, inflating the balloon can be effective to radially expand the valve positioning structure and the prosthetic valve. In this way, the prosthetic valve can be crimped around the valve positioning structure in the off-balloon position to further minimize the crimped profile of the prosthetic valve.

A prosthetic heart valve may include an expandable stent having a plurality of struts forming cells connected to one another in a plurality of annular rows around the stent, a cuff attached to an annulus section of the stent by cuff sutures that have a plurality of stitches extending through material of the cuff and looping around the struts, and a plurality of leaflets each having a belly attached to the cuff within an interior region of the stent. The leaflets may together have a coapted position occluding the interior region of the stent and an open position in which the interior region is not occluded. The belly of each leaflet may be attached to the cuff by leaflet sutures extending in a path that crosses some of the struts in overlap zones. Those struts may be devoid of the stitches within the overlap zones.

A radially compressible and expandable frame for a prosthetic heart valve assembly includes a plurality of interconnected frame elements forming a plurality of cells, which are arranged in a first circumferential row of cells defining an inflow end of the frame and a second circumferential row of cells defining an outflow end of the frame. An outflow portion of the second row of cells includes a circumferential row of angled frame elements interconnected to each other at a plurality of upper junctions and a plurality of lower junctions. The upper junctions define the outflow end of the frame and the lower junctions point toward the inflow end of the frame. The lower junctions are not connected to other portions of the frame.

Disclosed herein are delivery systems and methods for delivering a prosthetic heart valve to a native heart valve of a heart. An exemplary delivery system may include a shaft portion having at least one shaft, at least one steering wire, and at least one pull wire. The system may further include a handle portion coupled to a proximal end of the shaft portion and a capsule portion coupled to a distal end of the shaft portion. The capsule portion may be configured to house the prosthetic heart valve. At least one portion of the delivery system may be configured to be engaged with the prosthetic heart valve when the prosthetic heart valve is implanted in the native heart valve of the heart.

A prosthetic tricuspid heart valve system includes a collapsible anchor frame and a collapsible prosthetic heart valve. The anchor includes a support structure having a waisted central portion, and atrial and ventricular flared portions sized to clamp a native valve annulus. Atrial and ventricular sheets are coupled to the atrial and ventricular flared portions, and each include a central aperture. A generally cylindrical fabric valve-receiving member has an inflow end coupled to the atrial sheet and an outflow end coupled to the ventricular sheet to provide a conduit through the valve-receiving member between the atrial and ventricular sheet. The prosthetic heart valve may include a stent and a plurality of prosthetic leaflets, the prosthetic heart valve configured to be expanded into and received within the valve-receiving member of the anchor frame.

The present disclosure relates to prosthetic heart valves having elongated sealing members. As one example, a prosthetic heart valve includes an annular frame, a leaflet assembly including a plurality of leaflets, and a skirt assembly including an inner skirt, an outer skirt, and / or a third skirt. The frame is radially compressible and expandable between a radially compressed state and a radially expanded state, and includes a plurality of apices at an inflow end. The skirt assembly forms a pocket at the inflow end of the frame that creates additional space between the inflow end of the frame and the skirt assembly when the frame is in the radially expanded state. The pocket allows the apices at the inflow end of the frame to move toward the inflow end of the pocket without protruding through the skirt assembly when the frame is radially compressed to the radially compressed state.

A prosthetic heart valve delivery system may include a handle, an outer catheter extending distally from the handle, and a balloon mounted to a distal portion of the outer catheter. A prosthetic heart valve may be configured to be received on a balloon, and a balloon inflation system may be configured to inflate and deflate the balloon. The balloon may include a proximal balloon portion and a distal balloon portion positioned distal to the proximal balloon portion. The interior volume of the proximal balloon portion may be fluidly isolated from the interior volume of the distal balloon portion such that the proximal balloon portion and the distal balloon portion may be inflated independently of each other.

A surgical sutureless valve that is attached to a stent frame for delivery to a location in a patient using percutaneous implantation devices and methods.

A prosthetic heart valve includes an outer frame, an outer sealing skirt, an inner frame, an inner sealing skirt, a plurality of prosthetic leaflets mounted within the inner frame, and a plurality of connecting arms connecting the inner frame to the outer frame so that the inner frame is positioned radially inward of the outer frame. A bridging skirt extends from the outer sealing skirt to an inflow edge of the inner sealing skirt. The bridging skirt covers a gap between the inner frame and the outer frame. The inner sealing skirt may include at least one trench that interrupts an otherwise circular shape of the inflow edge of the inner sealing skirt, the trench extending in an outflow direction of the prosthetic heart valve.

A prosthetic heart valve with a collapsible and expandable outer frame which engages tissue of a native heart valve annulus. The outer frame has a narrowed waist portion between atrial and ventricular

Prosthetic valves are provided, e.g., for replacing a mitral or aortic valve of a patient, that includes an annular valve body including an inlet end, an outlet end, and one or more valve members for selectively opening and closing a passage between the inlet and outlet ends, a sewing cuff attached around an outer perimeter of the valve body, and a flexible skirt removably attached around the outer perimeter adjacent the sewing cuff. The prosthetic valve may be introduced into a patient's body, positioned adjacent a valve annulus, and the sewing cuff may be secured around a perimeter of the valve annulus. The skirt may be secured to tissue adjacent the valve annulus to further seal the prosthetic valve around the valve annulus, or the skirt may be removed from the valve body, e.g., if the annulus is sufficiently sealed by the sewing cuff.