25 results about "Paravalvular leak" patented technology

The present application discloses a paravalvular leak prevention material, a paravalvular leak prevention device, a paravalvular leak prevention skirt, a mold, a prosthetic heart valve, a prosthetic implant, and a related method. The prosthetic implant comprises: a stent having a radially-deformable cylindrical structure, the stent being provided with a through blood flow passage; a plurality of valve leaflets, each valve leaflet having a fixed edge and a free edge opposite to each other, wherein the fixed edge is fixed to the stent, and the free edge is used for controlling the blood flow passage; and a paravalvular leak prevention structure arranged in the circumferential direction of the stent, the paravalvular leak prevention structure being: a blocking component that at least partially radially protrudes (extends) out of the stent and uses a deformable structure; and / or an outer skirt wrapped around the outer periphery of the stent. The paravalvular leak prevention structure of the present application can make an inflow end of the stent have an adaptive blocking effect, thereby reducing paravalvular leak.

A prosthetic heart valve for replacing a native valve includes a stent extending between a proximal end and a distal end and including a plurality of struts forming cells, the stent having a collapsed condition and an expanded condition. At least one runner is coupled a cell, the at least one runner being configured to transition from a first configuration to a second configuration when the stent moves from the collapsed condition to the expanded condition, the at least one runner projecting radially outwardly from the cell in the second configuration. A valve assembly is disposed within the stent, the valve assembly including a plurality of leaflets, a cuff at least partially disposed on a luminal surface of the stent, and a covering material disposed on an abluminal surface of the stent and covering the at least one runner in the second configuration.

A prosthetic heart valve may include a collapsible and expandable stent extending in a flow direction between a proximal end and a distal end, a cuff attached to an annulus section of the stent and having an outer surface facing in a radial direction orthogonal to the flow direction, a plurality of prosthetic valve leaflets attached to the cuff, and a sealing structure attached to the annulus section of the stent at an inner edge of the sealing structure. The flow direction may be defined from the proximal end toward the distal end. The sealing structure may have an outer edge remote from the inner edge. The sealing structure may have a collapsed condition with the outer edge disposed adjacent the outer surface of the cuff and an expanded condition with the outer edge spaced apart from the outer surface of the cuff.

The present invention provides a series of new percutaneous concepts of paravalvular repairs including identifying the leak location, several repair techniques and finally built-in means for leak prevention, built on percutaneous valves. A catheter-delivered device locates cavities occurring between a prosthetic valve (250) and the wall of the body vessel where the valve is implanted, the cavities producing paravalvular leaks during diastole, the device comprising at least one of a plurality of flexible wires, the wire having attached to it a balloon, wherein the balloon is pulled by the leak through the cavity and wherein the wire then serves to mark the cavity location.

A prosthetic heart valve includes a collapsible stent and a valve assembly disposed within the stent. A first cuff is disposed adjacent the stent. A second cuff having a distal edge facing the outflow end of the stent is disposed about the stent radially outward of the first cuff and the stent. The stent may include a plurality of fingers each having a first end coupled to a corresponding cell of the stent and a free end adapted to extend radially outward of the corresponding cell. The distal edge of the second cuff may be coupled to the fingers at spaced locations around the circumference of the stent to position the distal edge radially outward from the corresponding cells at the spaced locations. Various stent struts may be tapered to reduce the stent circumference in the collapsed condition, and to improve the fatigue resistance and / or bendability of the stent.

A prosthetic heart valve may include a collapsible and expandable stent extending in a flow direction between a proximal end and a distal end, a cuff attached to an annulus section of the stent, a plurality of prosthetic valve leaflets each having a belly attached to the cuff between a first location and a second location downstream of the first location in a flow direction, and a sealing structure attached to the annulus section of the stent. The annulus section of the stent may be adjacent the proximal end. The stent may include a plurality of struts shaped to form a plurality of cells connected to one another in a plurality of annular rows around the stent. The sealing structure may have a deployed condition with a diameter greater than a diameter of the proximal end of the stent when the stent is in an expanded use condition.

A paravalvular leak resistant prosthetic heart valve system including a stent frame, a valve structure and a sealing mechanism. The stent frame has a surface. The valve structure is associated with the stent frame. The sealing mechanism at least partially extends over the surface of the stent frame. The sealing mechanism includes at least one semi-permeable membrane and an osmotic gradient driving material.

A prosthetic heart valve for replacing a native valve includes a collapsible and expandable stent having a proximal end and a distal end, and a valve assembly disposed within the stent, the valve assembly including a plurality of leaflets and a cuff annularly disposed about the stent. The cuff includes a surplus portion capable of forming a sealing structure having a diameter greater than a diameter of the proximal end of the stent when deployed.

A prosthetic heart valve for replacing a native valve includes a stent extending between a proximal end and a distal end and including a plurality of struts forming cells, the stent having a collapsed condition and an expanded condition. At least one runner is coupled a cell, the at least one runner being configured to transition from a first configuration to a second configuration when the stent moves from the collapsed condition to the expanded condition, the at least one runner projecting radially outwardly from the cell in the second configuration. A valve assembly is disposed within the stent, the valve assembly including a plurality of leaflets, a cuff at least partially disposed on a luminal surface of the stent, and a covering material disposed on an abluminal surface of the stent and covering the at least one runner in the second configuration.

A prosthetic heart valve for replacing a native valve includes a collapsible and expandable stent having a proximal end and a distal end, the stent being formed of a plurality of struts forming cells. A valve assembly is disposed within the stent, the valve assembly including a plurality of leaflets and a cuff. At least one runner is coupled to a cell and configured to transition from a first configuration to a second configuration when the stent moves from the collapsed condition to the expanded condition.

A system and method for restoring (e.g., replacing) a defective heart valve of a patient. A delivery system is manipulated to percutaneously deliver and implant a stented prosthetic heart valve to a native heart valve. A post-dilatation balloon is percutaneously delivered to the implantation site, and a compliant segment thereof is arranged within a region of the implanted prosthesis. The balloon is inflated such that the compliant segment expands and contacts the prosthesis, expanding a remodeling region of the prosthesis to a remodeled state. With these and related techniques, remodeling of an implanted, stented prosthetic heart valve to better match the native valve shape is possible, providing many benefits such as reducing the risk of paravalvular leaks.

Heart valve replacement often involves complications associated with paravalvular leaks. Vascular plug and occlusive devices, as well as heart valves particularly beneficial in treating the phenomenon of paravalvular leaks are described to address this issue.

The present invention provides a prosthetic heart valve device with improved fit, apposition and / or paravalvular leakage mitigation. Thus, the prosthetic device comprises an anchoring structure for supporting prosthetic valve leaflets, wherein the anchoring structure comprises and / or is formed at least partially from a hydrophilic material designed to swell when contacted by the water solute in the patient's blood. Locating the hydrophilic material to provide swelling to improve the fit and / or apposition of the device to the patient's tissues results in, inter alia, improved paravalvular leakage mitigation. Some of the methods and mechanisms described herein may also be used to provide a seal against the septal hole created during transseptal delivery of the device.

Heart valve replacement often involves complications associated with paravalvular leaks. Vascular plug and occlusive devices, as well as heart valves particularly beneficial in treating the phenomenon of paravalvular leaks are described to address this issue.

A prosthetic heart valve includes a stent frame with a first end portion, a second end portion, and a central portion extending between the first end portion and the second end portion. The stent frame extends in a first direction of a longitudinal axis of the prosthetic heart valve from the first end portion to the second end portion. The prosthetic heart valve further includes a support arm coupled to the stent frame, a valve structure associated with the stent frame, and a seal configured to expand to a swelled orientation by fluid passing into the seal.

A prosthetic heart valve may include a collapsible and expandable stent extending in a flow direction between a proximal end and a distal end, a cuff attached to an annulus section of the stent and having an outer surface facing in a radial direction orthogonal to the flow direction, a plurality of prosthetic valve leaflets attached to the cuff, and a sealing structure attached to the annulus section of the stent at an inner edge of the sealing structure. The flow direction may be defined from the proximal end toward the distal end. The sealing structure may have an outer edge remote from the inner edge. The sealing structure may have a collapsed condition with the outer edge disposed adjacent the outer surface of the cuff and an expanded condition with the outer edge spaced apart from the outer surface of the cuff.

A collapsible and expandable stent is described that is adapted to treat blood flow regurgitation in a mitral valve or a tricuspid valve of a heart by allowing downstream blood flow and preventing upstream blood flow. The stent comprises an outer section comprising a first stent cell pattern, and an inner valve support section extending radially upward into the outer section and comprising a second stent cell pattern. The inner valve support section supports prosthetic valve leaflets attached therein. The stent further comprises a transition section between the outer section and the inner valve support section comprising a third stent cell pattern that is different from the first stent cell pattern and the second stent cell pattern. The transition section turns radially inward to give rise to a radially upward extension of the inner valve support section within the outer section. The transition section further comprises a plurality of curvilinear struts comprising a degree of curvature and / or twist. A spacing between adjacent curvilinear struts defines the third stent cell pattern of the transition section. Adjacent curvilinear struts are configured to nest together when the stent is collapsed.

A device and method for anchoring or stabilizing a transcatheter bioprosthetic heart valve and treating or repairing paravalvular leaks following replacement of a patient's native cardiac valve, including the aortic, mitral, tricuspid, and pulmonary valves. The device includes a scaffold anchor that is placed through a native leaflet and into the adjacent annular region to anchor the transcatheter bio prosthetic heart valve due to lack of calcification, tissue asymmetry, or irregular annular morphology. The scaffold anchor may be delivered and positioned with standard transcatheter bioprosthetic heart valve delivery procedures, such as TAVR, TMVR, TTVR, and TPVR.

An apparatus includes multiple valvular plugs configured for deployment within one or more paravalvular leaks inside a heart of a patient and adjacent to a prosthetic heart valve. The apparatus also includes a valvular plug delivery catheter comprising a lumen. The valvular plugs are positioned proximate to one another inside the lumen, such that the valvular plug delivery catheter is configured to deploy a first valvular plug and a second valvular plug without the delivery catheter being removed from the body of the patient between deploying the first valvular plug and deploying the second valvular plug.

A prosthetic heart valve system includes a balloon expandable prosthetic heart valve and a delivery catheter. A prosthetic heart valve has an inflow end portion, an outflow end portion, and a central portion. The delivery catheter has a balloon assembly on a distal end portion of the delivery catheter, the balloon assembly having a proximal end portion, a distal end portion, and a central portion. In a delivery state of the system, the prosthetic heart valve crimps on the balloon while the balloon assembly is deflated. In a deployed state of the system, the balloon assembly is inflated such that the distal end portion of the balloon assembly has a diameter greater than a diameter of the central portion of the balloon assembly and such that the outflow end portion of the prosthetic heart valve flaps radially outward relative to the central portion of the prosthetic heart valve.

The present invention relates to a system, a method, a computer program and a computer program product for automatically assessing a risk of paravalvular leaks after a clinical intervention for implanting a prosthetic cardiac valve in a patient according to the independent claims. A system (100) for automatically assessing a risk of paravalvular leaks after a clinical intervention for implanting a prosthetic cardiac valve in a patient comprises an input interface (101) for obtaining data and a computing unit (102). The computing unit (102) is adapted to obtain first input data (201) acquired before the start of the clinical intervention via the input interface (101), the first input data comprising image data of a patient and comprising image data of a region of interest including the aortic root, preferably CT image data. The computing unit (102) is preferably adapted to pre-analyse the first input data. The computing unit (102) is adapted to classify the patient into one of two main classes of likelihood of paravalvular leaks on basis of the first input data.

A prosthetic heart valve (300) for replacing a native valve includes a collapsible and expandable stent (306) having a proximal end (302) and a distal end (304), and a valve assembly (308) including a plurality of leaflets (310), the valve assembly (308) being disposed within the stent. The heart valve (300) further includes a first plurality of elongated legs (320) coupled to the stent (306) and transitionable from an extended configuration to a relaxed configuration. A first sealing portion (322) connected to the first plurality of legs (320) forms a sealing structure (350) when the legs (320) transition to the relaxed configuration to reduce perivalvular leakage between the implanted valve and surrounding tissue.

The present invention relates to a system, a method, a computer program and a computer program product for automatically assessing a risk of paravalvular leaks after a clinical intervention for implanting a prosthetic cardiac valve in a patient according to the independent claims. A system (100) for automatically assessing a risk of paravalvular leaks after a clinical intervention for implanting a prosthetic cardiac valve in a patient comprises an input interface (101) for obtaining data and a computing unit (102). The computing unit (102) is adapted to obtain first input data (201) acquired before the start of the clinical intervention via the input interface (101), the first input data comprising image data of a patient and comprising image data of a region of interest including the aortic root, preferably CT image data. The computing unit (102) is preferably adapted to pre-analyse the first input data. The computing unit (102) is adapted to classify the patient into one of two main classes of likelihood of paravalvular leaks on basis of the first input data.