934 results about "Prosthetic heart" patented technology

The present invention provides a prosthetic heart valve device with improved fit and / or apposition between the device frame and left atrial tissue and / or the device base and the annular tissue of the left atrium to improve shifting of the implanted device and / or mitigate paravalvular leakage. The improved fit and / or apposition arises in various embodiments by providing or allowing an asymmetrical frame and / or frame base and / or providing a lower lip to aid in conforming to the asymmetrical shape of the atrium and / or ensure firm positioning therein. An additional benefit of these arrangement(s) is mitigation of paravalvular leakage as a result of improved fit and seal. In certain embodiments, the asymmetry of the frame assists with delivery of the device into the atrium.

Loading systems for prosthetic heart valve devices are disclosed. A loading funnel is provided within a watertight interior space that is at least partially filled or fillable with biocompatible fluid. Funnel may have a cylindrical end to which is connected a delivery catheter having a lumen that will receive the collapsed prosthetic heart valve device. An expanded prosthetic heart valve device may be placed within the funnel and pushed or pulled into the funnel which provides a predictable, reliable and repeatable surface for collapsing the prosthetic heart valve device. Ultimately the prosthetic heart valve device is collapsed and translated into the lumen of the delivery catheter for further translation therealong and release into the heart chamber of interest.

A prosthetic heart valve may include a balloon-expandable frame extending between an inflow end and an outflow end, a plurality of prosthetic leaflets mounted within the frame, and an inner skirt positioned between the plurality of prosthetic leaflets and the frame. The frame may include a first row of diamond-shaped cells at the inflow end of the frame, a second row of diamond-shaped cells, and a row of outflow cells positioned at the outflow end of the frame. Each cell in the row of outflow cells may not be diamond-shaped, and, in an expanded condition of the frame, each cell in the row of outflow cells may have a larger area than that of each cell in the first and second rows of diamond-shaped cells. Each outflow cell may be at least partially defined by a commissure attachment feature, and each outflow cell may lack symmetry.

Prosthetic heart valves each includes a link extending along a link axis and an axial frame. The axial frame includes a plurality of struts comprising a plurality of inner struts pivotally attached to a plurality of outer struts at a plurality of pivot nodes. A first pivot node of the plurality of pivot can be attached to the link and a second pivot node of the plurality of pivot nodes can move relative to the link along the link axis. Methods of radially expanding a prosthetic heart valve can comprise radially expanding the radially expandable frame from a radially retracted orientation to a radially expanded orientation while the second pivot node axially translates relative to the link.

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 being sized to receive the prosthetic heart valve in a collapsed condition. The inner shaft and the distal sheath may be movable relative to one another. The delivery device may also include a tube member and an outer sleeve overlying the tube member. The tube member may be configured to rotate or twist upon axial movement of the outer sleeve with respect to the tube member, the rotation or twisting of the tube member configured to rotate the prosthetic heart valve when the prosthetic heart valve is received within the compartment in the collapsed condition.

A radially expandable prosthetic valve can comprise an annular frame, at least one expansion mechanism and a cord. The annular frame can be radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. The expansion mechanism can comprise a first member attached to the frame at a first location and a second member attached to the frame at a second location axially spaced from the first location. The cord can extend at least partially along the expansion mechanism in a first direction, be reeved around a portion of the second member, and extend at least partially along the expansion mechanism in a second direction opposite the first direction. Applying a proximally directed force to a first portion of the cord can cause the second member to move relative to the first member, which can cause the frame to foreshorten axially and expand radially.

The present invention relates to a radially collapsible frame (1) for a prosthetic valve, the frame (1) comprising an outflow end region (3) at a proximal end of the frame (1) and an inflow end region (2) at a distal end of the frame (1), opposite to the outflow end region (3). The frame (1) further includes at least two radially spaced commissure attachment regions 910, 10′, 10″) and a cell structure (30), composed of a plurality of lattice cells being arranged radially around a flow axis of the frame (1) and connecting the at least two commissure attachment regions (10, 10′, 10″). Finally, at least one anchoring / positioning arch (20, 20′, 20″) is provided, wherein said at least one anchoring / positioning arch (20, 20′, 20″) radially overlaps the cell structure (30) at least partially. In order to form the inventive frame from as a single piece, the invention further relates to a method comprising bending the at least one anchoring / positioning arch (20, 20′, 20″) towards the cell structure (30) of the frame (1).

An automated system that can be used for prosthetic heart valve manufacturing or suturing procedures. The system can include a first automated fixture that includes an articulating arm and a target device holder. The system can also include one or more additional automated fixtures, which can be configured as one or more suturing arms that include another articulating arm and a needle holder. The first automated fixture can be configured to rotate a target device held by the holder to allow the one or more additional automated fixtures to perform operations such as form sutures on the target device without intervention of a human operator. The system can include a display system configured to display status information of a suturing procedure.

A prosthetic aortic valve device, delivery system, interventional system, and related method are disclosed. The device includes an inner frame having relative compressed and expanded configurations; leaflets connected to the inner frame and cooperating with each other to control opening and closing of the blood flow passage; and a positioning mechanism arranged in a circumferential direction of the inner frame, the positioning mechanism including a fixed end connected to the inner frame and a free end extending towards the inflow end, the positioning mechanism being configured to be switchable among a loaded configuration, a transition configuration, and a released configuration.

In some embodiments, a prosthetic heart valve includes a collapsible and expandable stent comprising a plurality of commissure attachment features, a valve assembly coupled to the collapsible and expandable stent, the valve assembly comprising a cuff and a plurality of leaflets, and a suture pattern coupling at least one of the plurality of leaflets to at least one of the cuff and the collapsible and expandable stent, the suture pattern comprising a reverse-running stitch having a first leg and a second leg.

A system for delivering a prosthetic heart valve may include, a handle, an outer catheter, an inner catheter, a nose cone coupled to the inner catheter, and an inflatable balloon having a proximal leg coupled to the outer catheter and a distal leg coupled to the nose cone or the inner catheter. A first valve retainer may be coupled to the inner catheter and positioned within the balloon. In an assembled state of the first valve retainer, an inner stop is directly fixed to the inner catheter and an outer stop is positioned around and coupled to the inner stop. The inner stop has a maximum outer diameter that is smaller than a maximum inner diameter of the distal leg. In the assembled condition of the first valve retainer, the outer stop has a maximum outer diameter that is larger than the maximum inner diameter of the distal leg.

A prosthetic heart valve and associated methods for assembling a prosthetic heart valve including a plurality of leaflets is disclosed. As one example, a prosthetic heart valve includes a frame; a plurality of commissure support elements, each connected the frame and including two axially-extending members spaced apart from one another to form a window; and a plurality of leaflets, each leaflet comprising a body and two opposing commissure tabs, each commissure tab arranged adjacent to another commissure tab to form a pair of commissure tabs that are disposed in a commissure support element to form a commissure. Each commissure tab includes a series of overlapping layers that include a first set of two overlapping layers that extends through the window and a second set of two overlapping layers that extends away from the first set of two overlapping layers and over an outer side of a corresponding axially-extending member.

A delivery apparatus can include a handle, a first shaft extending from the handle and having a proximal end portion coupled to the handle and a distal end portion and a second shaft extending coaxially over the first shaft and having a proximal end portion coupled to the handle and a distal end portion. The delivery apparatus can further include a shoulder coupled to the distal end portion of the second shaft and having a flared end portion configured to abut a prosthetic valve positioned around the first shaft in a radially compressed state, an extension portion extending from the shoulder, and at least one radiopaque marker disposed on the extension portion at a location within the prosthetic valve when the prosthetic valve is in a radially compressed configuration on the first shaft.

The present disclosure relates to balloon assemblies designed to permit blood flow through a central perfusion channel, at least when blood flows in a proximally-oriented direction. Such a balloon assembly can include one or more toroid balloons, each defining a cavity that can be independently fed by one or more inflation tubes coupled thereto to inflate the balloon. When the toroid balloons are inflated within a patient lumen or a prosthetic device, such as a prosthetic heart valve, blood is allowed to flow through the perfusion lumen. A balloon assembly can further include a flexible valve configured to regulate blood flow when the balloon assembly is inflated, to allow proximally directed flow through a channel formed in a flexible funnel thereof, and prevent backflow in the opposite direction.

An assistance system that can be used for prosthetic heart valve manufacturing or suturing procedures includes an automated fixture that can comprise an articulation arm and a target device holder. The target device holder can be positioned and oriented to reduce operator strain during a manufacturing or inspection process. The assistance system includes a user input device enabling the operator to move between positions to assist in such processes. The assistance system can also be trained by capturing sequences of position data corresponding to a manufacturing or inspection process.

The present disclosure relates to the technical field of medical devices, and in particular to catheter implant systems and included associated device, prosthetic heart valves and method. The interventional delivery system included includes a catheter assembly and a control handle connected to the catheter assembly, the catheter assembly has opposing distal and proximal ends and includes an inner sheath and an outer sheath slidably engaged with each other, the outer sheath includes a loading section and a sheath section in sequence from the distal end to the proximal end, the loading section is configured to enclose and keep the interventional device in a compressed state; the control handle includes a main handle and an auxiliary handle slidably fitted over the inner sheath, the proximal end of the inner sheath is connected to the main handle and the proximal end of the outer sheath is connected to the auxiliary handle.

A high-performance near-pure zinc alloy, a preparation method therefor and a use thereof, relating to the technical field of zinc alloys. The alloy component is that the content of Zn is greater than or equal to 99.5%, and the remaining trace alloy elements include at least two of the following 14 elements: Mg, Mn, Li, Cu, Ag, Ca, Sr, Fe, Zr, Ti, Al, C, Ga, and Si. The alloy has the yield strength ≥ 250 MPa, the tensile strength ≥ 320 MPa, the elongation ≥ 25%, the mechanical property change during one year of room-temperature storage ≤ 5%, the maximum bending force ≥ 2 kN, the stress corrosion sensitivity factor ≤ 15%, the size of corrosion pits after 60 days of immersion ≤ 15 μm, and the standard deviation of the size of corrosion pits ≤ 3 μm. The alloy is suitable for the preparation of biodegradable stents, bone implant devices, medical staplers or anastomotic nails for intestines, blood vessels or nerves, vascular clamps, guided bone or tissue regeneration membranes, heart valve protheses, dura mater repair membranes, soluble bridge plugs and fracturing balls for oil drilling, zinc alloy die castings, electroplated zinc materials, building zinc materials, battery-grade zinc, printing-grade zinc, and zinc-based brazing alloys.

A prosthetic valve includes a frame with inflow and outflow ends and a longitudinal axis extending therebetween. The frame is in a radially expanded state defining a radially expanded diameter and is configured to define a partially radially compressed diameter when the frame is in a partially radially compressed state. A sealing skirt coupled to the frame includes inflow and outflow end portions, an inelastic skirt portion with weft and warp threads, and a tensioning element extending circumferentially along the outflow end portion. The sealing skirt includes a terminal outflow edge configured to define a skirt diameter greater or equal to the partially radially compressed diameter and less than the radially expanded diameter when the sealing skirt is in a relaxed state. The weft and warp threads are configured to be oriented at an approximately 45-degree angle to the longitudinal axis when the sealing skirt is in the relaxed state.

The present invention discloses a prosthetic heart valve comprising at least two valve components, a sealant covering the valve components, and an edge-sealing structure. A space is formed between the valve components covered with the sealant. The edge-sealing structure has a closed end face and connects the ends of the sealant to form a closed space within the space. The prosthetic heart valve provided by the present invention can reduce the risk of thrombosis between the valve components. Because the edge-sealing structure is flexible, it has little effect on the compression and gripping of the prosthetic valve, and the addition of the edge-sealing structure does not affect the normal function of the prosthetic valve.

Delivery systems are used for medical devices. For example, this document describes delivery systems for implantable medical devices such as, but not limited to, prosthetic heart valves that are deliverable in a minimally invasive manner using a system of catheters. The delivery systems may include a valve stop member that establishes the longitudinal position of the prosthetic heart valve on a balloon member. Such a valve stop member can be constructed as a braided wire body or cellular body to provide multiple advantages.

Prosthetic valves including a frame and a plurality of leaflets disposed within a lumen of the frame. The frame is radially compressible and expandable to transition the prosthetic valve between a compressed configuration and an expanded configuration. In some examples, the frame can include two rows of cells, each cell defining an aperture. The first, inflow row of cells can be generally diamond-shaped and the second, outflow row of cells can be generally chevon-shaped. In some examples, the frame including the two rows of cells is an outer frame and the prosthetic valve further includes an inner frame.

Delivery catheters for delivery of prosthetic heart valves are provided. The delivery catheters include brim recapture funnels configured for recapture of prosthetic heart valves. The brim recapture funnels are configured to recapture valve brims of partially deployed prosthetic heart valves to reduce or minimize damage to patient anatomy during a valve withdrawal procedure. Brim recapture funnels as described herein may be activated via suture control.

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 heart valve 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 is disclosed, together with methods of using same. 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 expanded form when subjected to an outward force such as that provided by a dilation balloon or other mechanical expander.

A prosthetic heart valve includes a collapsible and expandable outer frame, a collapsible and expandable inner frame, and a prosthetic valve assembly. The outer frame may be configured to engage tissue of a native heart valve, and may have (i) an atrial portion adapted to be positioned on an atrial side of the native heart valve; (ii) a ventricle portion adapted to be positioned on a ventricle side of the native heart valve; and (iii) a narrowed waist portion between the atrial portion and the ventricle portion. The inner frame may be positioned radially inward of the outer frame and may be coupled to the outer frame. A constraining band may extend around a circumference of the inner frame. The prosthetic valve assembly may be coupled to, and positioned radially inward of, the inner frame.

A device for treating a diseased native valve in a patient is provided, the device including a frame structure; a valve segment positioned radially within the frame structure, the valve segment comprising a plurality of leaflets, and a plurality of commissure attachment mechanisms coupling the leaflets to the frame structure, each commissure attachment mechanism extending radially inwards from an outflow end of the frame structure as to create a gap between an interior diameter of the outflow end and an outflow edge of the valve segment. Other embodiments and methods of use are also provided.

A prosthetic heart valve for treatment of a diseased heart valve having native anterior and posterior leaflets that move between an open configuration and a closed position to regulate blood flow through the heart valve during a cardiac cycle of a heart. The prosthetic heart valve having a crescent shaped stent, at least one prosthetic leaflet mounted on an inner surface of the stent, and at least one prong structure coupling a portion of the at least one prosthetic leaflet to a lower ventricular portion of the stent frame. The prosthetic heart valve further having systems for anchoring the upper flared portion of the stent to a posterior portion of the native valve annulus.

The invention relates to an anchor hook and methods of using the same for subannular anchoring of a transcatheter heart valve replacement, and in particular for an orthogonally delivered (side-delivered) transcatheter prosthetic heart valve having a annular support frame having compressible wire cells that facilitate rolling and folding the valve length-wise, or orthogonally to the central axis of the flow control component, allowing a very large diameter valve to be delivered and deployed to the mitral or tricuspid valve from the inferior vena cava or superior vena cava, or trans-septally to the mitral valve, the valve having a height of about 5-60 mm and a diameter of about 25-80 mm, without requiring an oversized diameter catheter and without requiring a delivery catheter to bend 90 degrees during deployment.

An implantable prosthetic device can include a radially expandable and compressible annular frame comprising an inflow end portion and an outflow end portion, and a plurality of leaflets arranged within the frame. Each leaflet can include one or more commissure tabs. The commissure tabs of two adjacent leaflets coupled to a commissure attachment member to form a commissure. The commissure can be secured to the frame via first and second sutures, each suture extending through a respective commissure tab, through the commissure attachment member, crossing over the other suture and being secured to the frame. The commissure can define a bending axis disposed radially inwardly of the frame such that a main body of each leaflet is prevented from contacting the frame when the valvular structure is in an open configuration.