34 results about "Mitral heart valve" patented technology

A percutaneous heart valve prosthesis (1) has a valve body (2) with a passage (9) extending between the first and second ends (7, 8) of the valve body (2). The valve body (2) is collapsible about a longitudinal axis (10) of the passage (9) for delivery of the valve body (2) via a catheter (18). One or more flexible valve leaflets (3, 4) are secured to the valve body (2) and extend across the passage (9) for blocking bloodflow in one direction through the passage (9). An anchor device (5), which is also collapsible for delivery via catheter (18), is secured to the valve body (2) by way of an anchor line (6). A failed or failing mitral heart valve (101) is treated by percutaneously locating the valve body (2) in the mitral valve orifice (102) with the anchor device (5) located in the right atrium (107) and engaging the inter-atrial septum (103), such that the taught anchor line (6) acts to secure the valve body (2) within the mitral valve orifice (102).

A mitral heart valve annuloplasty ring having a posterior bow that conforms to an abnormal posterior aspect of the mitral annulus. The ring may be generally oval having a major axis and a minor axis, wherein the posterior bow may be centered along the minor axis or offset in a posterior section. The ring may be substantially planar, or may include upward bows on either side of the posterior bow. The ring may include a ring body surrounded by a suture-permeable fabric sheath, and the ring body may be formed of a plurality of concentric ring elements. The ring is semi-rigid and the posterior bow is stiff enough to withstand deformation once implanted and subjected to normal physiologic stresses. The ring elements may be bands of semi-rigid material. A method of repairing an abnormal mitral heart valve annulus having a depressed posterior aspect includes providing a ring with a posterior bow and implanting the ring to support the annulus without unduly stressing the attachment sutures.

A percutaneous heart valve prosthesis (1) has a valve body (2) with a passage (9) extending between the first and second ends (7, 8) of the valve body (2). The valve body (2) is collapsible about a longitudinal axis (10) of the passage (9) for delivery of the valve body (2) via a catheter (18). One or more flexible valve leaflets (3, 4) are secured to the valve body (2) and extend across the passage (9) for blocking bloodflow in one direction through the passage (9). An anchor device (5), which is also collapsible for delivery via catheter (18), is secured to the valve body (2) by way of an anchor line (6). A failed or failing mitral heart valve (101) is treated by percutaneously locating the valve body (2) in the mitral valve orifice (102) with the anchor device (5) located in the right atrium (107) and engaging the inter-atrial septum (103), such that the taught anchor line (6) acts to secure the valve body (2) within the mitral valve orifice (102).

An anatomically approximate prosthetic heart valve includes dissimilar flexible leaflets, dissimilar commissures and / or a non-circular flow orifice. The heart valve may be implanted in the mitral position and have one larger leaflet oriented along the anterior aspect so as to mimic the natural anterior leaflet. Two other smaller leaflets extend around the posterior aspect of the valve. A basic structure providing peripheral support for the leaflets includes two taller commissures on both sides of the larger leaflet, with a third, smaller commissure between the other two leaflets. The larger leaflet may be thicker and / or stronger than the other two leaflets. The base structure defines a flow orifice intended to simulate the shape of the mitral annulus during the systolic phase. For example, the flow orifice may be elliptical. A relatively wide sewing ring has a contoured inflow end and is attached to the base structure in such a way that the valve can be implanted in an intra-atrial position and the taller commissures do not extend too far into the left ventricle, therefore avoiding injury to the ventricle.

A percutaneous heart valve prosthesis (1) has a valve body (2) with a passage (9) extending between the first and second ends (7, 8) of the valve body (2). The valve body (2) is collapsible about a longitudinal axis (10) of the passage (9) for delivery of the valve body (2) via a catheter (18). One or more flexible valve leaflets (3, 4) are secured to the valve body (2) and extend across the passage (9) for blocking bloodflow in one direction through the passage (9). An anchor device (5), which is also collapsible for delivery via catheter (18), is secured to the valve body (2) by way of an anchor line (6). A failed or failing mitral heart valve (101) is treated by percutaneously locating the valve body (2) in the mitral valve orifice (102) with the anchor device (5) located in the right atrium (107) and engaging the inter-atrial septum (103), such that the taught anchor line (6) acts to secure the valve body (2) within the mitral valve orifice (102).

Prosthetic mitral heart valves and anchors for use with such valves are provided that allow for an improved implantation procedure. In various embodiments, a helical anchoring device is formed as a coiled or twisted anchor that includes one or more turns that twist or curve around a central axis. Curved arms attached to the frame of the valve guide the helical anchoring device into position beneath the valve leaflets and around the mitral valve annulus as it exits the delivery catheter, and the expandable prosthetic mitral valve is held within the coil of the anchoring device. The anchoring device and the valve can be delivered together, simplifying the valve replacement procedure.

An improved holder and method for implanting a tissue-type prosthetic mitral heart valve that prevents suture looping and may also constrict the commissure posts of the valve. An upstanding or shaft member axially positioned on the holder causes the lengths of attachment sutures to extend axially beyond the commissure post tips to create a tent and prevent looping of any of an array of pre-implanted sutures around the tips during deployment of the valve. The shaft member may be axially movable such that it can be initially retracted and then actuated just prior to valve deployment. The shaft member may have notches on its distal tip for capturing the attachment sutures, which are crossed over along the valve axis to ensure engagement by the notches. The attachment sutures may be strands or filaments, or may be wider bands of flexible biocompatible material. If bands are used, they desirably cover the commissure post tips to further help prevent suture looping thereover. The flexible lengths of material extend directly between commissures of the valve, or may extending radially inward from each commissure to a central upstanding member.

A mitral heart valve annuloplasty ring having a posterior bow that conforms to an abnormal posterior aspect of the mitral annulus. The ring may be generally oval having a major axis and a minor axis, wherein the posterior bow may be centered along the minor axis or offset in a posterior section. The ring may be substantially planar, or may include upward bows on either side of the posterior bow. The ring may include a ring body surrounded by a suture-permeable fabric sheath formed of a plurality of concentric ring elements or bands. The posterior bow is stiff enough to withstand deformation once implanted and subjected to normal physiologic stresses. A method of repairing an abnormal mitral heart valve annulus having a depressed posterior aspect includes providing a ring with a posterior bow and implanting the ring to support the annulus without unduly stressing the attachment sutures.

A prosthetic mitral heart valve having four separate flexible leaflets. The heart valve includes a support frame that may be non-circular, for example elliptical or “D-shaped”. The support frame may have an undulating outflow edge defined by four inflow cusps and four outflow commissures to which each of the flexible leaflets attaches. The support frame may comprise an undulating wireform and a surrounding stent defining a structure having four cantilevered posts projecting in the outflow direction to support the four leaflets. The heart valve is designed to be secured in the annulus and function as a standalone unit without papillary muscle connections to the leaflets. The four leaflets may be arranged in two opposed pairs, one pair being smaller than the other pair. The larger pair of leaflets may be identical, or differently sized. Existing sizes of heart valve leaflets may be utilized with the smaller leaflets being at least two leaflet sizes smaller than the larger leaflets in odd millimeter increments.

An improved holder, system and method for implanting a tissue-type prosthetic mitral heart valve that prevents suture looping and may also constrict the commissure posts of the valve. The holder may include two relatively movable plates, one of which attaches to the valve sewing on the inflow end of the valve ring and the other which attaches via sutures or similar expedient to the valve commissures on the outflow end. Separation of the plates places the sutures in tension and constricts the commissures. The sutures may be strands or filaments, or may be wider bands of flexible biocompatible material. If bands are used, they desirably cover the commissure post tips to further help prevent suture looping thereover. The flexible lengths of material extend directly between commissures of the valve, or may extending radially inward from each commissure to a central upstanding member. Desirably, a slide is created by the flexible lengths of material adjacent each commissure post, for example by crossing over suture filaments at or radially inward from the commissure posts. If an upstanding member is used, the lengths of suture extend axially beyond the commissure post tips to create a tent that wards off sutures that otherwise might loop around the tips during advancement of the valve along an array of pre-implanted sutures.

An anatomically approximate prosthetic heart valve includes dissimilar flexible leaflets, dissimilar commissures and / or a non-circular flow orifice. The heart valve may be implanted in the mitral position and have one larger leaflet oriented along the anterior aspect so as to mimic the natural anterior leaflet. Two other smaller leaflets extend around the posterior aspect of the valve. A basic structure providing peripheral support for the leaflets includes two taller commissures on both sides of the larger leaflet, with a third, smaller commissure between the other two leaflets. The larger leaflet may be thicker and / or stronger than the other two leaflets. The base structure defines a flow orifice intended to simulate the shape of the mitral annulus during the systolic phase. For example, the flow orifice may be elliptical. A relatively wide sewing ring has a contoured inflow end and is attached to the base structure in such a way that the valve can be implanted in an intra-atrial position and the taller commissures do not extend too far into the left ventricle, therefore avoiding injury to the ventricle.

Devices, systems, and methods employ a heart implant structure that is sized and configured to be positioned in a left atrium above the plane of a native mitral heart valve annulus to affect mitral heart valve function. The implant structure includes a portion sized and configured to engage a wall of the left atrium above the plane of the native mitral valve annulus and to extend across the left atrium along a minor axis of the annulus.

A holder for a prosthetic mitral heart valve that attaches to an inflow end of the valve and includes a simple tensioning mechanism that flexes the heart valve commissure posts inward to help prevent suture looping. The tensioning mechanism may include relatively movable rings of the holder or a generally unitary holder with a tensor, or rotatable knob. Connecting sutures thread through internal passages in the holder and travel in the outflow direction along valve commissure posts, emerging at the post tips and mutually crossing over the outflow side of the valve. A handle attaches off-center on the holder to increase visualization of and access to the heart valve through a central window. The holder is constructed of non-metallic materials so as to avoid interfering with imaging devices, and the handle is ergonomically curved and shaped to facilitate manipulation. The holder may be shaped as a ring with an open inner diameter for enhanced access to the commissure posts and leaflets.

A mitral heart valve annuloplasty ring having a posterior bow that conforms to an abnormal posterior aspect of the mitral annulus. The ring may be generally oval having a major axis and a minor axis, wherein the posterior bow may be centered along the minor axis or offset in a posterior section. The ring may be substantially planar, or may include upward bows on either side of the posterior bow. The ring may include a ring body surrounded by a suture-permeable fabric sheath, and the ring body may be formed of a plurality of concentric ring elements. The ring is semi-rigid and the posterior bow is stiff enough to withstand deformation once implanted and subjected to normal physiologic stresses. The ring elements may be bands of semi-rigid material. A method of repairing an abnormal mitral heart valve annulus having a depressed posterior aspect includes providing a ring with a posterior bow and implanting the ring to support the annulus without unduly stressing the attachment sutures.

The invention relates to a mitral heart valve prosthesis and a delivery catheter to carry and deploy such a prosthesis. The invention allows to effectively treat a pathology related to moderate to severe mitral regurgitation. Such a prosthesis implantable by catheterism includes mainly a docking station and a leaflet cooperating with the docking station. The leaflet is advantageously arranged in a configuration close to a posterior leaflet of a native mitral valve of a patient.

A prosthetic heart valve having an inflow end, an outflow end and a longitudinal axis extending from the inflow end to the outflow end includes a collapsible and expandable stent including a plurality of cells arranged in at least one row extending around a circumference of the stent. The stent further includes at least one engaging arm joined to one of the cells adjacent the outflow end and having a free end extending toward the inflow end, the engaging arm being movable between a loaded condition in which the engaging arm is oriented substantially parallel with the longitudinal axis of the stent, a partially-released condition in which the engaging arm forms a first angle with the longitudinal axis of the stent, and a fully-released condition in which the engaging arm forms a second angle with the longitudinal axis of the stent, the first angle being larger than the second angle.

A prosthetic mitral heart valve including a contoured sewing ring that better matches the mitral valve annulus. The sewing ring includes an inflow end and an outflow end, the outflow and having at least one raised portion. There may be two raised portions located approximately 120° apart from each other and designed to register with two anterior trigones of the mitral valve annulus. The sewing ring may be formed by a suture-permeable annular member surrounded by a fabric covering, the annular member desirably being molded of silicone. The raised portion(s) may gently curve upward to a height of about 2 mm above the adjacent portions of the outflow end of the sewing ring. The sewing ring may also be constructed so as to be more flexible around a posterior aspect than around an anterior aspect to accommodate calcified tissue more commonly found around the posterior annulus. The contoured sewing ring can be combined with various types of heart valve including bioprosthetic and mechanical valves. A bioprosthetic heart valve of the present invention may include a support stent having three outflow commissures alternating with three inflow cusps, with two of the commissures being located at the same place as two raised portions of the sewing ring. A method of implant includes tilting the prosthetic heart valve in the mitral annulus so that a posterior commissure angles away from the ventricular wall and reduces the chance of contact therebetween.

A prosthetic mitral heart valve including a contoured sewing ring that better matches the mitral valve annulus. The sewing ring includes an inflow end and an outflow end, the outflow and having at least one raised portion. There may be two raised portions located approximately 120° apart from each other and designed to register with two anterior trigones of the mitral valve annulus. The sewing ring may be formed by a suture-permeable annular member surrounded by a fabric covering, the annular member desirably being molded of silicone. The raised portion(s) may gently curve upward to a height of about 2 mm above the adjacent portions of the outflow end of the sewing ring. The sewing ring may also be constructed so as to be more flexible around a posterior aspect than around an anterior aspect to accommodate calcified tissue more commonly found around the posterior annulus. The contoured sewing ring can be combined with various types of heart valve including bioprosthetic and mechanical valves. A bioprosthetic heart valve of the present invention may include a support stent having three outflow commissures alternating with three inflow cusps, with two of the commissures being located at the same place as two raised portions of the sewing ring. A method of implant includes tilting the prosthetic heart valve in the mitral annulus so that a posterior commissure angles away from the ventricular wall and reduces the chance of contact therebetween.

A prosthetic heart valve having an inflow end and an outflow end includes a collapsible and expandable stent including a plurality of cells arranged in rows extending around a circumference of the stent, at least one of the rows forming a flared portion having a diameter that is larger than diameters of others of the rows. The stent further includes engaging arms disposed adjacent the outflow end and extending toward the inflow end, the engaging arms being configured to couple to heart tissue to anchor the stent. A collapsible and expandable valve assembly has a plurality of leaflets disposed within the stent.

Prosthetic mitral heart valves and anchors for use with such valves are provided that allow for an improved implantation procedure. In various embodiments, a helical anchoring device is formed as a coiled or twisted anchor that includes one or more turns that twist or curve around a central axis. Curved arms attached to the frame of the valve guide the helical anchoring device into position beneath the valve leaflets and around the mitral valve annulus as it exits the delivery catheter, and the expandable prosthetic mitral valve is held within the coil of the anchoring device. The anchoring device and the valve can be delivered together, simplifying the valve replacement procedure.

An improved holder and storage system for a tissue-type prosthetic mitral heart valve that constricts the commissure posts of the valve and prevents suture looping. A rod axially movable relative to the holder tensions lengths of attachment sutures that extend between the commissure post tips to create a tent and flex the tips inward, thus helping to prevent looping of any of an array of pre-implanted sutures around the leading tips during delivery of the valve. The holder has a safety mechanism that prevents valve delivery before the rod is deployed. One embodiment automatically deploys the rod upon opening a storage jar. One embodiment permits a delivery handle to directly deploy the rod, while another uses a separate worm screw and coupling. A holder clip that attaches to a packaging sleeve may be formed of flexible members meshed together from which the heart valve and holder are easily pulled free to eliminate a step of decoupling the clip from the sleeve.

A prosthetic heart valve having an inflow end and an outflow end includes a collapsible and expandable stent including a plurality of cells arranged in rows extending around a circumference of the stent, at least one of the rows forming a flared portion having a diameter that is larger than diameters of others of the rows. The stent further includes engaging arms disposed adjacent the outflow end and extending toward the inflow end, the engaging arms being configured to couple to heart tissue to anchor the stent. A collapsible and expandable valve assembly has a plurality of leaflets disposed within the stent.

A holder for a prosthetic mitral heart valve that attaches to an inflow end of the valve and includes a simple tensioning mechanism that flexes the heart valve commissure posts inward to help prevent suture looping. The tensioning mechanism may include relatively movable rings of the holder or a generally unitary holder with a tensor, or rotatable knob. Connecting sutures thread through internal passages in the holder and travel in the outflow direction along valve commissure posts, emerging at the post tips and mutually crossing over the outflow side of the valve. A handle attaches off-center on the holder to increase visualization of and access to the heart valve through a central window for enhanced access to the commissure posts and leaflets. The holder is constructed of non-metallic materials so as to avoid interfering with imaging devices, and the handle is ergonomically curved and shaped to facilitate manipulation.

A polymeric mitral heart valve, comprising: valve leaflets (3), a valve stent (1) and a valve ring (2), wherein the valve stent (1) is of a hollow columnar structure, the valve stent (1) comprises a first end (11) and a second end (12), the first end (11) is provided with three column peaks (13) spaced apart in the circumferential direction and column valleys (14) are correspondingly formed; the valve ring (2) is arranged at the periphery of the second end (12) of the valve stent (1), two protruding sections (21) extending towards the first end (11) in the axial direction are formed at the periphery of the valve ring (2) to be capable of corresponding to two of the column peaks (13), and a flat section (22) is formed at a position corresponding to the other column peak (13); the valve further comprises an insert (5), the insert (5) is of a hollow columnar structure matching the valve stent (1), and the insert (5) is suitable for being embedded in the valve stent (1) in the axial direction; the valve leaflets (3), the valve stent (1) and the valve ring (2) undergo one-time injection molding, and the insert (5) is embedded in the valve stent (1) during injection molding to form a whole. By optimizing the structures of the valve ring (2) and the valve stent (1), the adaptability of the valve ring (2) to a native valve ring is improved, the radial support force of the valve stent (1) is improved, and the valve performance is optimized.

An improved holder and storage system for a tissue-type prosthetic mitral heart valve that constricts the commissure posts of the valve and prevents suture looping. A rod axially movable relative to the holder tensions lengths of attachment sutures that extend between the commissure post tips to create a tent and flex the tips inward, thus helping to prevent looping of any of an array of pre-implanted sutures around the leading tips during delivery of the valve. The holder has a safety mechanism that prevents valve delivery before the rod is deployed. One embodiment automatically deploys the rod upon opening a storage jar. One embodiment permits a delivery handle to directly deploy the rod, while another uses a separate worm screw and coupling. A holder clip that attaches to a packaging sleeve may be formed of flexible members meshed together from which the heart valve and holder are easily pulled free to eliminate a step of decoupling the clip from the sleeve.

The invention relates to a prosthetic mitral heart valve consisting of a support housing (10) comprising a base ring (15) supporting two posts which point essentially in the direction of the ring axis and which are connected by arc-shaped walls (13, 14), these walls being used to fix two flexible leaflets. The free ends of said posts form an inner support for the leaflet. The base ring, as seen from above, has a closed, noncircular shape with a common longitudinal axis but two different-sized semi lateral axes. The posts lie on the longitudinal axis and form the transitional point from one half of the shape to the other. The invention provides that in order to avoid undercuts which can contribute to turbulence, the plane in which the connection line (17) between the tips of the posts (18, 19), and the common longitudinal axis of the post base ring shape lie is tilted at an angle (alpha) of 10° to 20°, preferably 15°, in relation to the plane that leads through the common longitudinal axis and lies vertically in relation to the surface (21) formed by the base ring; and the wall with the greater curvature supports the leaflet with the smaller surface (the mural leaflet), positioned at a greater angle to the surface formed by the base ring compared to the wall with the greater curvature.

A prosthetic heart valve includes a collapsible and expandable stent extending along a longitudinal axis and having an inflow end and an outflow end, the stent including a plurality of cells annularly arranged around the stent in at least one row, the plurality of cells having a first nesting cell adjacent the outflow end of the stent, a first engaging arm disposed within the first nesting cell and being pivotally movable between a loaded condition, a partially-released condition, and a fully-released condition, the first engaging arm and the first nesting cell having a synchronous pivoting movement, and a collapsible and expandable valve assembly disposed within the stent and having a plurality of leaflets.

An instrument for repairing an atrioventricular heart valve, mitral heart valve or tricuspid heart valve includes a first tube having a tube axis defining an axial direction. A leaflet grabbing structure is arranged at a distal part of the first tube and contiguous to the first tube. The leaflet grabbing structure has a main body and a jaw, the jaw being movable relative to the main body. The jaw has a first proximally facing abutment surface and the main body has a second, distally facing abutment surface. The instrument has a needle that is cannulated and forms an inner tube. The needle is releasable from the first tube and movable relative to the main body in axial directions. The leaflet grabbing structure clamps a leaflet of the heart valve between the first and second abutment surfaces, while the jaw allows the needle to extend therethrough.