648 results about "Prosthetic heart" patented technology

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 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.

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.

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.

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 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.

A prosthetic heart valve delivery system may include a delivery device having a balloon at a distal end thereof, a balloon-expandable prosthetic heart valve configured to be received on the balloon in a crimped condition, and a loader sheath configured to at least partially surround the crimped prosthetic heart valve while the crimped prosthetic heart valve is received on the balloon. The loader sheath may include a tube and a proximal hub. The loader sheath may include a first channel extending in an axial direction along a wall of the tube and a second channel extending parallel to the first channel. The first channel and the second channel may form weakened areas to promote tearing of the tube along the first channel and along the second channel.

A method of implanting a prosthetic heart valve within a patient can comprise inserting a distal end portion of a delivery apparatus and a prosthetic heart valve into the patient and advancing the prosthetic heart valve to a deployment location within the heart of the patient and inflating one or more of a plurality of differently-sized balloons in a balloon-assembly on the distal end portion of the delivery apparatus. The prosthetic heart valve can be mounted on the balloon assembly in a crimped state and the inflating of the one or more of the plurality of differently-sized balloons can expand the prosthetic heart valve from the crimped state to a radially expanded state having a non-cylindrical shape.

The invention discloses an artificial heart valve near-physiological pulsation fluid external evaluation device and method, and relates to the technical field of heart valve testing.The artificial heart valve near-physiological pulsation fluid external evaluation device comprises a supporting frame, a driving unit, a tested valve installation unit and an artery and peripheral loop unit, the driving unit provides power for liquid flowing, and the tested valve installation unit is used for fixing an artificial heart valve; and a liquid volume assembly and a resistance assembly of the artery and peripheral loop unit can simulate the compliance and resistance of aorta blood vessels and peripheral artery blood vessels, so that the pressure waveform simulation of the systemic circulation loop is more accurate. On the basis of the air cavity, the elastic corrugated pipes with different frequency responses are arranged, the compliance and rebound resilience of the aorta are simulated, a device for rapidly replacing the tested valve is designed, and the mechanical property of the simulated human body aorta is adjusted by adjusting the parameters such as the output frequency and the vibration amplitude of the driving unit; real pressure and flow waveforms under different physiological / pathological conditions are simulated, and a more accurate and convenient detection environment is realized.

A delivery apparatus including a measurement device to monitor the real-time diameter of a prosthetic heart valve can include a handle, at least one first actuator extending from the handle and being configured to apply a distally directed force to a proximal end portion of a prosthetic heart valve, at least one second actuator extending from the handle and being configured to apply a proximally directed force to a distal end portion of a prosthetic heart valve, a sensor, and first and second motion-transmitting members coupled to the first and second actuators, respectively, and having proximal ends coupled to the sensor, wherein the sensor senses relative movement between the motion-transmitting members upon actuation of the first and second actuators to determine the diameter of the prosthetic heart valve as it expands from a radially compressed configuration to a radially expanded configuration.

A prosthetic valve includes a frame and a flow control component. The frame has an aperture extending through the frame about a central axis. The flow control component is mounted within the aperture and is configured to permit blood flow in a first direction approximately parallel to the vertical axis from an inflow end to an outflow end of the flow control component and to block blood flow in a second direction, opposite the first direction. The frame has an expanded configuration with a first height along the central axis, a first lateral width along a lateral axis perpendicular to the central axis, and a first longitudinal length along a longitudinal axis perpendicular to the central axis and the lateral axis. The frame has a compressed configuration with a second height less than the first height and a second lateral width less than the first lateral width.

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.

Disclosed is a transcatheter delivery system including a catheter assembly and a control handle connected to the proximal end of the catheter assembly. Control handle includes a first handle and multiple sets of driving mechanisms, each set including: a driven member axially mounted to the first handle, slidable along the axial direction, and configured to connect to a corresponding tube; and a driving member rotationally mounted to the first handle, which is located at the periphery of driven member with internal threads. Driven member has driving teeth that engage with the internal threads. Control handle further includes indicator member connected to the driven member and an elastic member connected to the driven member. When elastic member moves axially with driven member to a position corresponding to indicator member, elastic member and indicator member engage with each other to provide a tactile response and / or a sound response.

A prosthetic heart valve can comprise a stent frame radially movable between a contracted configuration and a maximum expanded configuration. The stent assembly can comprise a plurality of longitudinally extending jack strut assemblies, wherein each jack strut assembly comprises a proximal jack strut comprising a distal surface, a distal jack strut comprising a proximal surface, and a jack screw connecting the proximal jack strut and the distal jack strut. The proximal surface of each distal jack strut does not contact the distal surface of each respective proximal jack strut when the stent assembly is in the contracted configuration. The proximal surface of each distal jack strut contacts the distal surface of each respective proximal jack strut when the stent assembly is in the maximum expanded configuration.

Coverings and / or skirts for prosthetic heart valves are disclosed. As an example, a prosthetic heart valve comprises a frame comprising three axially extending commissure support portions, a plurality of rows of angled struts including a first row defining an inflow end, a second row downstream of the first row, and a third row downstream of the second row and defining an outflow end, where downstream ends of the struts of the second row are connected to each other at junctions, and the commissure support portions extend from respective junctions to the third row of struts. The valve further comprises leaflets forming three commissures secured to respective commissure support portions, and an outer skirt comprising an outflow edge forming three circumferentially spaced projections aligned with the commissure support portions and covering respective junctions, the outflow edge comprising straight sections extending between adjacent projections upstream of the junctions.

To provide devices, systems, and methods for a collapsible and expandable heart valve assembly that is highly flexible, resilient, retractable, and replaceable.SOLUTION: Disclosed herein are systems and methods for a replacement heart-valve delivery system, comprising a replacement heart valve and a delivery component. The delivery component enables control of the replacement heart valve such that it can control collapsing and expanding the heart valve. Due to the nature of the flexible wire frame making up the heart valve, as well as its size, the delivery component allows for flexibility in the delivery catheter. The claimed invention thus allows for less traumatic delivery, more precise delivery, and a greater number of options on how to deliver.SELECTED DRAWING: Figure 1

A radially collapsible and expandable prosthetic heart valve is disclosed. A frame of the prosthetic valve can have radially offset commissure windows. In some examples, a plurality of commissure window elements includes at least one support post and a commissure window frame disposed radially inward from the adjacent cells of the valve frame.

A system for loading a delivery apparatus including a crimping device and a loading assembly. The crimping device having a housing including a funnel segment and an outlet in communication with the funnel segment, and an actuator configured to advance a radially expanded prosthetic device at least partially through the funnel segment and outlet thereby partially crimping the prosthetic device. The loading assembly including a support tube disposable over at least a portion of a capsule of a delivery apparatus, the loading assembly comprising an inlet end configured to be disposed adjacent the outlet of the crimping device such that the loading assembly can be axially advanced over the partially crimped prosthetic device to move the prosthetic device into a fully compressed configuration.

In some embodiments, a method includes providing a prosthetic heart valve including a collapsible and expandable stent having struts and a valve assembly coupled to the stent, the valve assembly having a plurality of leaflets and a cuff, providing a delivery device including a catheter extending between a proximal end and a distal end, an inflatable balloon, a handle coupled to the catheter, and a memory for storing data disposed within the handle, recording at least one of part-to-part noise factors and process variation factors and storing it in the memory, calculating an adjusted inflation parameter based on the at least one of part-to-part noise factor and process variation factor, advancing the delivery device to a native aortic valve of a patient while the prosthetic heart valve is disposed about the inflatable balloon, and inflating the balloon according to the adjusted inflation parameter.

Prosthetic heart valves and methods for assembling prosthetic heart valves are disclosed. As one example, a prosthetic heart valve includes a frame, commissure support elements, and leaflets, each leaflet comprising a body and opposing commissure tabs, each commissure tab folded over from a corresponding body to form a bend between the commissure tab and body and arranged adjacent to another folded commissure tab of an adjacent leaflet to form a pair of commissure tabs that is coupled to one commissure support element to form a commissure. Each commissure tab is secured to the commissure support element via a reinforcement member positioned against the commissure tab, adjacent to the bend, and secured to and / or at least partially wrapped around the commissure tab and the commissure support element, the reinforcement member comprising a flexible body and a more rigid, central portion, the central portion positioned along a height of the commissure tab.

A prosthetic valve includes an annular frame and a valvular structure mounted within the annular frame. The valvular structure comprises a plurality of leaflets and a plurality of offset elements. Each leaflet includes a leaflet free edge that is offset in an axial direction from the commissures by upper material portions that are unattached to the frame. Commissures are formed by primary tabs on the side edges of adjacent leaflets attached to secondary tabs on opposing ends of the offset elements. A bridge portion of the offset elements extends over an end portion of the leaflet free edges of the adjacent leaflets and is moveable between a neutral position and a radially outward shifted position. An articulation axis between the adjacent leaflets is offset greater distance from the frame when the bridge portion is in the neutral position relative to when the bridge portion is in the radially outward shifted position.

A medical assembly can include a radially expandable prosthetic heart valve and a delivery apparatus. The delivery apparatus can include a handle, an actuation member, and a force limiting mechanism within the handle including a pivot arm coupled to a base portion. The actuation member can apply a proximally directed force to the prosthetic valve to cause the valve to expand. The actuation member can be coupled to the pivot arm such that a force applied to the actuation member causes the pivot arm to pivot. The force limiting mechanism can pinch the actuation member between the pivot arm and the base portion when the force applied to the actuation member exceeds a predetermined force to prevent proximal movement of the actuation member and can allow proximal movement of the actuation member to produce radial expansion of the prosthetic valve when the force applied is less than the predetermined force.

A heart valve prosthesis is positioned within an index valve prosthesis. The heart valve prosthesis includes an annular frame extending along a valve axis between a first valve end and a second valve end. The annular frame includes a plurality of frame members and is adjustable between a radially-collapsed configuration and a radially- expanded configuration. The annular frame includes a central region including a folded segment that moves between a first configuration and a second configuration. The folded segment is biased toward the second configuration. The folded segment defines a channel on an outer radial side of the folded segment when the folded segment is in the second configuration. The channel receives at least one lacerated leaflet of the index valve prosthesis. Methods of implanting a heart valve prosthesis are provided.

A method of fracturing a previously-implanted prosthetic surgical heart valve may include advancing a non-compliant balloon of a balloon catheter through a patient's vasculature until the balloon is positioned at least partially within the previously-implanted prosthetic surgical heart valve. Inflation media may be advanced through an inflation lumen and into the balloon to inflate the balloon. A pressure within the inflation lumen may be measured during advancing the inflation media. A volume of inflation media advanced through the inflation lumen and into the balloon may be measured. A relationship between the measured pressure and the measured volume of inflation may be monitored, as the inflation media is advanced into the balloon, to identify distinct phases of balloon inflation.