CN116710027A - Systems, devices, and methods for a folded integrated heart valve stent - Google Patents

Systems, devices, and methods for a folded integrated heart valve stent Download PDF

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Publication number
CN116710027A
CN116710027A CN202180088000.XA CN202180088000A CN116710027A CN 116710027 A CN116710027 A CN 116710027A CN 202180088000 A CN202180088000 A CN 202180088000A CN 116710027 A CN116710027 A CN 116710027A
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China
Prior art keywords
wall
valve
region
stent
struts
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CN202180088000.XA
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Chinese (zh)
Inventor
D·T·华莱士
J·J·博耶特
P·W·格雷格
S·C·诺埃
E·N·海恩斯
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Kapstein Medical Co ltd
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Kapstein Medical Co ltd
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Priority claimed from PCT/US2021/056915 external-priority patent/WO2022094001A1/en
Publication of CN116710027A publication Critical patent/CN116710027A/en
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Abstract

The present application provides a replacement heart valve comprising a one-piece, folded double-walled stent having a stent covering, and a leaflet valve attached to a lumen of the stent. The heart valve is delivered using a multi-pulley, suture-based stent constraining assembly provided by a fixed guide opening or structure along the distal end of the delivery system, independently allowing expansion of the distal and proximal ends of the outer wall of the stent, and controlling expansion of the inner wall to occur simultaneously or separately from expansion of the outer wall.

Description

Systems, devices, and methods for a folded integrated heart valve stent
Background
The present application relates generally to treating valve disease, and more particularly to methods and devices for minimally invasive mitral valve replacement.
Valvular heart disease is a significant burden on patients and healthcare systems, with prevalence of 2-3% worldwide, and increasing prevalence in the elderly population. Valve disease may be caused by a variety of causes, including autoimmune, infectious, and degenerative causes. Epidemiology of valve disease also varies from valve to valve affected, with rheumatic heart disease being the cause of global primary mitral insufficiency and mitral stenosis, but in developed countries, mitral valve disease secondary to left ventricular dysfunction is more common.
Although surgical repair and valve replacement remain the primary means of many mitral valve therapies in the current clinical guidelines of the american heart association and american society of cardiology, the use of transcatheter mitral valve repair is recommended for certain patient populations. In guidelines for 2017 focus renewal and 2014 valve disease patient management, AHA/ACC suggests that percutaneous mitral valve saccule combined with capsulotomy treatment of severe mitral stenosis, transcatheter mitral valve repair treatment of some symptomatic primary severe and reasonably life-time mitral regurgitation patients who are candidates for non-surgical treatment due to complications.
Disclosure of Invention
The difficulties of mitral valve anatomy and physiology challenges further development of transcatheter mitral valve therapy compared to more mature transcatheter aortic valve therapy. For example, some developing mitral valve replacement therapies compromise between the sealing and anchoring properties of the outer portion of the replacement valve and the support of the leaflet valve. Other treatments attempt to address this challenge by two-part replacement valve structures, but these treatments may have a high failure rate of delivery or be too large for transcatheter delivery.
To address these issues, embodiments described herein relate to a replacement heart valve that includes a one-piece, folded double-wall stent having a stent cover and a leaflet valve attached to a lumen of the stent. The double-walled stent structure decouples or reduces the impact on the retention structure of the valve support (support) geometry. This includes external forces acting through the valve annulus during the cardiac cycle, as well as the effects of non-circular valve annulus shape. The double-walled stent structure also allows the valve support to have a different size and shape than the outer-ring support without conforming to the natural anatomy. By allowing the outer wall to have a shorter longitudinal length than the inner wall supporting the valve leaflets, this can reduce the risk of outflow tract obstruction and/or damage due to ventricular contractions. The unitary design may also allow for greater structural integrity by reducing the complexity associated with force concentrations between joined, welded or mechanically connected support members and/or their in-situ attachment.
In some variations, this allows the expandable valve to contract to a size less than 29F, for example less than 10 millimeters, or between 24F and 29F, or between 8 millimeters and 10 millimeters. The heart valve may be delivered using a multi-pulley, suture-based stent constraining assembly on a catheter or delivery tool. A fixed guide opening or structure along the distal end of the delivery system independently allows the distal and proximal ends of the outer wall of the stent to be expanded via sutures passing through the opening. Controlling the expansion of the inner wall may occur simultaneously or independently of the expansion of the outer wall. The double-wall integrated design reduces the complexity of a valve having a multipart structure while decoupling the geometry of the valve support from the retaining structure while still providing foldability suitable for transcatheter delivery.
In one example, a replacement heart valve is provided that includes an integrated stent frame having a folded double wall. The stent frame includes a collapsed configuration and an expanded configuration; an outer wall comprising an open expanded diameter region, a middle reduced diameter region, and a closed expanded diameter region; a tubular inner wall having a central lumen; and a transition wall between the outer wall and the inner wall; and a replacement leaflet valve positioned within the inner wall central lumen. The integrated stent frame may further comprise a first fold between the closed expanded diameter region and the tubular inner wall. The integrated stent frame may further include a second fold between the closed expanded diameter region and the open expanded diameter region. The outer wall may surround at least 70% of the inner wall in the expanded configuration. In the collapsed configuration, the outer wall and the transition wall may completely surround the inner wall. The tubular inner wall includes a non-foreshortened region surrounding the replacement valve when transitioning from the collapsed configuration to the expanded configuration. The inner wall may be a non-shortened inner wall and the outer wall may be a shortened outer wall. The radius of curvature at the first fold is smaller than the radius of curvature at the second fold. The integrated stent frame may further comprise a plurality of longitudinal struts, wherein each longitudinal strut is positioned continuously along the inner wall, transition wall and outer wall. In some variations, for at least one or all of the plurality of longitudinal struts, consecutive sections of the longitudinal struts in the inner, transition and outer walls are coplanar. The continuous section of the longitudinal strut is also coplanar with a central longitudinal axis of the integrated stent frame. The plurality of longitudinal struts may be integrally formed with the plurality of circumferential struts. In some examples, at least three circumferential struts are located in the outer wall. The valve may further comprise a stent cover comprising a first region on the outer surface of the outer wall, a second region on the open end of the outer wall, a third region on the outer surface of the transition wall, a fourth region on the inner surface of the inner wall, a fifth region on the open end of the inner wall, a sixth region on the outer surface of the inner wall, a seventh region on the inner surface of the outer wall, and an eighth region portion between the inner surface of the outer wall and the outer surface of the inner wall. The first, second, third and fourth regions may comprise a first textile structure, the fourth region and the fifth region may comprise a second textile structure, and the sixth, seventh and eighth regions may comprise a third textile structure. The first fabric structure and the third fabric structure may comprise a first fabric material and the second fabric structure may comprise a second fabric material different from the first fabric material. The first web material may be less permeable and thinner than the second web material. The plurality of longitudinal struts and the plurality of circumferential struts may comprise a segmented annular cross-sectional shape, and wherein an orientation of the segmented annular cross-sectional shape in the inner wall is opposite an orientation of the segmented annular cross-sectional shape in the outer wall.
In another embodiment, a replacement heart valve is provided that includes a unitary stent frame having a folded double wall, the stent frame including an outer wall including an open expanded diameter region, a middle reduced diameter region, and a closed expanded diameter region; a cylindrical inner wall having a central lumen, a transition wall between the outer wall and the inner wall; and a replacement leaflet valve positioned within the central lumen of the inner wall. The integrated stent frame may further comprise a plurality of longitudinal struts, wherein each longitudinal strut comprises a longitudinal outer wall section and a longitudinal inner wall section continuous with the transition surface section. For at least one of the plurality of longitudinal struts, the longitudinal outer wall section, the transition surface section, and the longitudinal inner wall section may be continuously coplanar. The integrated stent frame may include a central longitudinal axis, and wherein the continuous coplanar longitudinal outer wall section, transition surface section, longitudinal inner wall section of each of at least one of the plurality of longitudinal struts is also coplanar with the central longitudinal axis. In some examples, adjacent ones of the plurality of longitudinal struts may be formed with a plurality of chevron struts in a circumferential direction. Each of the plurality of longitudinal struts may include a longitudinal outer wall section, a transition surface section, and a continuous coplanar longitudinal inner wall section. The integral stent frame may have a relatively small radius of curvature at the transition junction between the outer wall and the transition surface and a relatively large radius of curvature at the transition junction between the transition surface and the inner wall.
In yet another example, a stent may be provided that includes an integrated double-walled expandable stent frame having a central opening and a central axis, and includes an expanded configuration and a contracted configuration. The stent frame may be a folded stent frame. The folded stent frame may be an everted or inverted stent frame. The stent frame may further comprise a circumferential inner wall comprising an open end, a transition end, and inner and outer surfaces therebetween; a circumferential outer wall including an open end, a transition end, and inner and outer surfaces therebetween; and a transition wall between the transition ends of the inner wall and the outer wall. The inner wall of the stent frame may be non-foreshortened in the expanded configuration relative to the contracted configuration. The stent frame may further comprise an annular cavity between the inner wall and the outer wall, the cavity comprising an annular closed end at the transition wall and an annular open end between the open ends of the inner wall and the outer wall. The outer wall may include an intermediate region having a reduced cross-sectional area relative to a cross-sectional area at an end region of the outer wall in the expanded configuration. The inner wall may comprise a cylindrical or frusto-conical shape. In the contracted configuration, the inner surface of the outer wall may be spaced closer to the outer surface of the inner wall, and wherein in the expanded configuration, the inner surface of the outer wall is longitudinally spaced distally of the outer surface of the inner wall relative to the contracted configuration. The stent frame may further comprise a first delivery configuration wherein the transition ends of the inner and outer walls are in a partially expanded configuration and the open ends of the inner and outer walls are in a partially contracted configuration. The transition wall may have a transverse orientation relative to the central axis in the expanded configuration, and a longitudinal orientation relative to the central longitudinal axis and a radially outward position relative to the inner wall in the contracted configuration. The stent frame may have a smaller radius of curvature at the transition end of the outer wall relative to a larger radius of curvature at the transition end of the inner wall, or may have a larger radius of curvature between the open end of the outer wall and the transition end relative to a smaller radius of curvature at the transition end of the outer wall. The stent frame includes a plurality of longitudinal struts, wherein each longitudinal strut includes a longitudinal outer wall section that is contiguous with and radially aligned with a longitudinal inner wall section by a transition wall section. Adjacent ones of the plurality of longitudinal struts may be circumferentially spaced apart via a plurality of chevron struts. Each of the plurality of chevron struts may include a first leg and a second leg, wherein each leg includes a base end integrally formed with one of the adjacent longitudinal struts and a distal end integrally formed with a distal end of the other leg. The integrally formed distal ends of the first and second legs may include a hairpin configuration. At least some of the plurality of chevron struts may be oriented in a tangential plane defined by adjacent longitudinal strut sections, each chevron strut being integrally formed around the adjacent longitudinal strut sections. At least one of the plurality of chevron struts may be oriented radially out of plane from the tangential plane. The out-of-plane chevron struts may be integrally formed with adjacent longitudinal struts in the outer wall, and wherein the hairpin formations protrude into the reduced diameter region of the stent frame and point toward the transition end of the outer wall. In some variations, the replacement heart valve may further comprise a leaflet valve sutured to the inner wall. The plurality of chevron struts may include a plurality of undulating circumferential struts. The stent may further comprise a first fabric cover comprising an outer cuff covering a portion of an outer surface of the outer wall, an open end of the outer wall, and a portion of the inner surface of the outer wall; and a second fabric covering a portion of an outer surface of the outer wall, the transition wall, and a portion of a surface of the inner wall. The open end of the inner wall may be offset from the open end of the outer wall along the central longitudinal axis.
In yet another embodiment, a replacement heart valve is provided that includes an integrated stent frame having a folded double-walled hourglass shape, the stent frame including an outer wall having an hourglass shape including an open expanded diameter region, a middle reduced diameter region, and a closed expanded diameter region; a non-shortened tubular inner wall having a central lumen; and a transition wall between the outer wall and the inner wall; and a replacement leaflet valve positioned within the central lumen of the inner wall.
In another example, a method of using a heart valve delivery system is provided, the method comprising: the method includes inserting a delivery catheter through a central opening of a valve and an integral folding double-walled valve frame, releasably attaching a first retaining assembly to an inner wall of the valve frame, releasably attaching a second retaining assembly to an outer wall of the valve frame, tensioning the first retaining assembly to fold the inner wall of the valve frame onto the delivery catheter, and tensioning the second retaining assembly to fold the outer wall of the valve frame onto the inner wall of the valve frame. Folding (collapsing ) of the outer wall of the valve frame may include distally tensioning, stretching, or pulling the outer wall of the valve frame toward the distal end of the catheter. The method may further comprise sliding a delivery sheath of the delivery catheter over the collapsed valve.
In another example, a method for performing mitral valve replacement is provided, the method comprising positioning a delivery device comprising a collapsed heart valve assembly in an orthogonal centered posture through a native mitral valve, wherein the heart valve assembly comprises an integral folding stent and attached valve leaflets; retracting the sheath of the delivery device to expose the collapsed heart valve; expanding an atrial end of an outer wall of the integrated folding support in the left atrium; expanding a ventricular end of an outer wall of the integrated folding stent in the left ventricle; the inner wall of the integrated folding bracket is expanded; releasing the integrated folded heart valve from the delivery device. The method may further comprise: into the femoral vein, inserting the transseptal puncturing device through the femoral vein and into the right atrium, puncturing the atrial septum, and inserting the delivery device with the collapsed heart valve assembly through the femoral vein and into the left atrium. In some further examples, the atrial end of the expanded outer wall and the ventricular end of the expanded outer wall may occur at least partially simultaneously. The atrial end of the expanding outer wall and the expanding inner wall may also occur at least partially simultaneously. The method may further comprise dilating the atrial septum. Alternatively, the method may further comprise accessing the left thoracic cavity through the chest wall, puncturing the heart tissue at the apex of the left ventricle, and inserting the delivery device with the collapsed heart valve assembly through the chest wall and transapically into the left ventricle. For the latter method, the transition end of the integral folding leg has a proximal position on the delivery device and the open end of the integral folding leg may have a distal position on the delivery device. In yet another embodiment, the method may further comprise accessing the femoral artery and inserting a delivery device having a collapsed heart valve assembly into the left ventricle through the femoral artery and aortic arch.
Drawings
FIGS. 1A and 1B are schematic side and top views of one embodiment of a heart valve stent; FIG. 1C is a partial cross-sectional view of the heart valve stent of FIG. 1A with a portion of the outer wall omitted; FIG. 1D is a schematic cross-sectional view of FIG. 1B; FIG. 1E is a schematic cross-sectional view of the inner wall (excluding the outer wall) of a heart valve stent; fig. 1F is a schematic cross-sectional view of an outer wall (excluding an inner wall) of a heart valve stent, and fig. 1F is a schematic cross-sectional view of fig. 1B; FIG. 1G is a schematic assembly view of two longitudinal struts from FIG. 1A;
FIGS. 2A and 2B schematically depict cross-sectional configurations of struts in an outer wall and an inner wall of an exemplary folded stent structure;
FIGS. 3A and 3B schematically depict cross-sectional configurations of struts in an outer wall and an inner wall of another exemplary folded stent structure;
FIGS. 4A-4C depict various exemplary strut configurations;
FIG. 5A is a schematic side view of another embodiment of a heart valve stent having attached leaflet valves and a skirt; FIGS. 5B and 5C are schematic bottom and top perspective views of the heart valve stent of FIG. 5A; FIG. 5D is a schematic top perspective view of a variation of the cuff structure of FIG. 5C;
Fig. 6A-6C are top perspective, top plan and side views of a skirt structure for a heart valve stent; FIG. 6D is a cross-sectional view of the skirt structure of FIGS. 6A-6C;
FIGS. 7A and 7B are atrial/top and ventricular/bottom views of an implanted heart valve; and
fig. 8A-8E are schematic cross-sectional views of exemplary views of a deployment procedure for a heart valve stent and delivery system.
Detailed Description
Embodiments herein relate to a double-walled folded stent structure having an inner wall that provides a tubular lumen for attachment to a leaflet valve assembly. The inner wall is spaced apart from a tubular outer wall configured to seal and/or anchor to surrounding native valve anatomy, but adjoining the inner wall via a transition wall. The transition wall may be created by folding, inverting, or everting a single tubular structure into a double-walled, unitary tubular stent frame or structure. The stent is configured to reversibly collapse into a reduced diameter or reduced cross-sectional shape for loading into a catheter and for delivery to a target anatomical site, and then re-expand at the implantation site.
In further embodiments, the folded scaffold structure may be shaped with a middle region of reduced cross-sectional dimensions in the outer wall, which may facilitate anchoring of the structure on a desired anatomical site. The intermediate region having a reduced diameter or size is configured to expand against the native valve leaflet and/or anatomical orifice, while the increased diameter or size of the end regions provides mechanical interference or resistance to displacement. The transition wall of the stent structure may be configured to promote fluid flow into the lumen and through the replacement valve leaflets while reducing turbulence and/or hemodynamic forces that may dislodge or dislodge the valve. For example, the transition wall may be angled or tapered radially inward from the outer wall to the inner wall as compared to a transition wall oriented orthogonally between the outer wall and the inner wall, or as compared to the longitudinal axis of the stent structure, to improve flow or reduce peak forces acting on the transition wall.
Although some of the exemplary embodiments described herein relate to transcatheter replacement of a mitral valve, the components and structures herein are not limited to any particular valve or delivery method, and may be adapted for implantation in tricuspid, pulmonary, aortic valve locations, as well as non-cardiac locations, such as the aortic, venous or cerebrospinal fluid systems, or natural or artificial catheters, tubes, or shunts. As used herein, spatial references to the first or upper end of the assembly may also be characterized by the anatomical space occupied by the assembly and/or the relative direction of fluid flow. For example, a first or upper end of a folded stent structure replacing a mitral valve may also be referred to as the atrial or upstream end of the valve, while the opposite end may be referred to as the ventricular or downstream end of the valve.
An exemplary embodiment of a stent structure 100 is depicted by fig. 1A-1G in its expanded configuration. The stent structure 100 includes a lumen 102 formed by an inner wall 104. The outer wall 106 is radially spaced from the inner wall 104 by a transition wall 108 and forms an annular cavity 110. The support structure 100 has a first closed end 112 at the transition wall 108 and a second open end 114 of the outer wall 106, wherein the annular cavity 110 is open and accessible.
The lumen 102 includes a first opening 116 surrounded by the transition wall 108 and a second opening 118 at the second open end 114 of the stent structure 100. The longitudinal axes 120, 320 of the lumens 102 generally coincide with the central axis of the stent structure 100, but in some variations the lumens may be positioned eccentrically with respect to the outer wall of the stent structure. The lumen 102 generally includes a circular cross-sectional shape having a generally cylindrical shape between the first opening 116 and the second opening 118, as shown in fig. 1A-1D. In other embodiments, the lumen may comprise a frustoconical, elliptical, or polygonal shape. In some variations, the stent structure may include a lumen, wherein the first opening and the second opening may be different in size and/or shape. The length of the lumen 102 may be in the range of 10 millimeters to 50 millimeters, 15 millimeters to 40 millimeters, or 20 millimeters to 25 millimeters, and the diameter or maximum cross-sectional dimension of the lumen along its longitudinal length may be in the range of 15 millimeters to 40 millimeters, 20 millimeters to 30 millimeters, or 25 millimeters 30 millimeters. In embodiments where the lumen includes a non-cylindrical shape, the difference between the diameters or cross-sectional dimensions of the first opening 116 and the second opening 118 may be in the range of 1 millimeter to 10 millimeters, 1 millimeter to 5 millimeters, or 1 millimeter to 3 millimeters.
The position of the first and second openings 116, 118 of the lumen 102 relative to the entire stent structure 100 may also vary. In some variations, the first opening 116 of the lumen 102 may be recessed relative to the first end 112, as shown in fig. 1A-1G. In other examples, the first opening may be substantially flush with the first end transition wall of the bracket structure. The position of the first opening 116 may also be characterized as recessed, flush, or protruding relative to the longitudinal position of the inner wall 104 or the inner junction 122 between the lumen 102 and the transition wall 108, or relative to the outer junction 124 between the transition wall 108 and the outer wall 106, as shown in fig. 1G. Likewise, the second opening 118 of the inner cavity 102 may also be characterized as recessed, flush, or protruding relative to the longitudinal position of the outer opening 126 of the outer wall 106. For example, with respect to the stent structure 100, the second opening 118 of the inner lumen 102 includes an offset or protruding position relative to the outer opening 126 of the outer wall 106. In some variations, the lumen may protrude relative to the second opening of the outer wall, with the smaller or shorter outer wall preferably to accommodate smaller sized native valve anatomy. However, the lumen size may remain relatively the same size between different dimensional variations to provide consistent valve geometry and/or hemodynamic characteristics.
The transition wall 108 of the stent structure 100 has a generally annular and slightly conical shape surrounding the lumen 102 in the expanded configuration, but may have different shapes and/or surface angles in other variations. Referring to fig. 1G, for example, the transition wall 108 in cross-section may include a generally linear shape between the inner joint 122 and the outer joint 124, but in other variations may include a curved shape, such as concave or convex. In other variations, the transition wall may have a generally orthogonal angle relative to the longitudinal axis of the lumen. Returning to fig. 1G, the transition wall 108 of the stent structure 100 may form an acute outer angle 128 with respect to the longitudinal axis 120 of the lumen 102. The angle 128 may range from +45 to +89 degrees, +75 to +89 degrees, or +81 to +85 degrees, with optional variations ranging from + -1 degrees, + -2 degrees, + -3 degrees, or + -4 degrees. In other variations, the transition wall angle may be in the range of-45 degrees to +45 degrees, -75 degrees to +75 degrees, or-85 degrees to +85 degrees.
As previously described, in some embodiments, the outer wall 106 of the stent structure 100 comprises a non-cylindrical shape when in the expanded configuration. The outer wall 106 may include a first end region 140, a second end region 142, the first end region 140 meeting the transition wall 108 and including an outer convex shape, the second end region 142 forming the outer opening 126. As shown, the inner joint 122 between the upper region of the inner wall 104 and the transition wall 108 may include a first or upper inner radius of curvature R along the curved inner curvature 1 A first or upper inner bend angle A 1 . The bending angle refers to an angle defined by the arc length of a bend, starting from the center of the radius of curvature, between the points where the bend transitions to a linear section or different bends. The outer junction 124 between the transition wall 308 and the upper region of the outer wall 106 may include a second or upper outer radius of curvature R 2 And a second or upper external bend angle A 2 . The intermediate region of the outer wall 108 includes a third or intermediate radius of curvature R 3 And a third or intermediate bending angle A 3 And a lower region of the outer wall 108 may include a fourth or lower radius of curvature R 4 And a fourth or lower bending angle A 4 。
As shown in FIG. 1G, a first radius of curvature R 1 Second radius of curvature R 2 May be located within the annular cavity 110 of the stent 100, with a third radius of curvature R 3 May be located outside of the outer wall 108 and a fourth radius of curvature R 4 May be in the ipsilateral annular chamber 110, the inner chamber 102, the contralateral annular chamber 110b, depending on the size.
The radius of curvature and the angle of curvature of the stent structure may be used to define the geometry of the stent in the expanded configuration, but also affect the geometry of the stent in its delivery or collapsed configuration. Regions or sections of the scaffold mayTo be configured with a smaller radius of curvature and/or a larger angle of curvature to facilitate folding the stent at that region or section as the stent collapses for delivery or collapsed configuration. A larger radius of curvature or smaller bend angle may be provided to facilitate straightening of the region or section for delivery or collapse configurations. For example, for the stent structure 100, the radius of curvature R is relatively small 1 Facilitating folding or collapsing of the stent structure at the internal junction 122 with a larger radius of curvature R 2 Facilitating planarization of the first end region 140 during transport or loading of the device into the transport system. Thus, in the collapsed configuration, the transition wall 108 is further curved at the interior junction 122 and collapses around the inner wall 104. The outer wall 106 also collapses around the inner wall 104, but not around the transition wall 108. Similarly, the intermediate region 142 and the second end region 144 of the outer wall 106 may also be provided with a larger radius of curvature R 3 And R is 4 This will result in a flattening of the concave shape in the intermediate region 142 and the convex shape of the second end region 144, also facilitating collapse of the outer wall 106. Thus, for the stent 100 in its collapsed configuration, the inner wall 104 will be radially closer to the outer wall 106 and the transition wall 108. The outer wall 106 and the transition wall 108 will be in contact with the sheath, capsule or outer wall of the delivery system, while the inner wall 104 may be in contact with the inner core or inner catheter wall. In other embodiments, the stent structure may be provided with a relatively large radius of curvature R 1 And a smaller radius of curvature R 2 Such that in the collapsed configuration, the transition wall will collapse against the delivery device recently, rather than the inner wall 104, and wherein the outer wall 106 collapses against the inner wall 104 and the transition wall 108.
In some variations, the stent geometry may be characterized by one or more opposing features of the stent in its expanded configuration. For example, the stent 100 may be characterized by a 3 >A 1 And A 3 >A 2 And A 3 >A 4 And/or R 1 <R 2 <R 3 <R 4 、R 1 <R 2 ≈R 3 ≤R 4 、R 1 <R 2 ≈R 3 ≈R 4 Or R 1 <R 2 ≤R 3 ≤R 4 。
Other stent variations may include:
1)R 2 <R 1 <R 3 <R 4 ；
2)R 2 <R 1 ≈R3<R 4 ；
3)R 2 <R 1 ≈R 3 ≈R 4 ；
4)R 4 >R 1 ≈R 2 ；
5)R 4 >R 1 ≈R 2 >R 3 ；
6)A 2 :A 1 in a ratio in the range of 1 to 3, 1.5 to 2.5, or 1.8 to 2.2;
7)A 3 :A 4 in a ratio in the range of 1 to 4, 1.5 to 3.0, or 2.2 to 2.4;
8)A 2 :A 4 in a ratio in the range of 2 to 4, 2.5 to 3.5, or 2.8 to 3.2;
the stent structure herein further comprises a plurality of integrally formed stent strut sections as shown in fig. 1A-1G. Some struts may be characterized as longitudinal strut sections 130a, 130b, 130c that generally lie in radial planes in which the longitudinal axis of the stent structure also lies; or lateral strut sections 134a, 134b, 134c integrally formed with the longitudinal struts 130a, 130b, 130c, 132a, 132b, 132c, wherein the two longitudinal struts 130, 132 respectively lie in different adjacent radially oriented planes. In embodiments having an even number of equally spaced longitudinal struts, as shown in fig. 1G, each radial plane 150 will include the longitudinal axis 120 of the stent structure 100, and two longitudinal struts 130, 136 on opposite sides of the stent structure 100. The longitudinal and lateral strut sections may be further grouped, with a set of longitudinal strut sections lying in the same radial plane to form continuous lengths of longitudinal struts 130, 132 in the inner wall 104, transition wall 108, and/or outer wall 106.
In some examples, a longitudinal strut comprising a plurality of consecutive longitudinal strut sections disposed in one wall may terminate or terminate at the junction of the next wall, but in some embodiments may span two or three walls. In some further embodiments, the longitudinal struts may be disposed along the entire folded length of the stent structure, between the openings of the inner lumen, along the length of the inner wall, and through the transition wall and the end of the outer wall to the outer wall, while still having each continuous strut section lying in the same radial plane 150, as the longitudinal struts 130, 152 depicted in fig. 1G. It can be seen that this arrangement of a plurality of consecutive longitudinal struts through a folded stent structure provides structural integrity to the stent structure which better redistributes forces acting on the stent structure, while less force concentrations are found in a stent structure comprising a plurality of welded or attached together components, both at the point of manufacture and at the point of use. In other examples, the continuous length of the longitudinal struts may span all three walls, but the stent may include different strut configurations, e.g., different orientations of circumferential struts or tissue anchors, at one or both of the inner and outer ends of the folded stent structure.
In the exemplary stent structure 100, the longitudinal strut sections along the lumen of the stent structure 100 comprise a linear configuration, and thus the longitudinal strut sections are substantially parallel in both their expanded and contracted configurations. With this arrangement, the lumen 102 does not exhibit any foreshortening when changing from a contracted configuration to an expanded configuration. This may reduce or eliminate any axial stretching of the valve structure attached to the lumen. This may also allow the lumen to be predictably positioned and deployed while reducing the risk of accidental positional misalignment.
While the non-cylindrical configuration of the outer wall 106 may exhibit some foreshortening with the outer wall 106, transitioning from a relatively straight orientation in the collapsed configuration to a convex/concave/convex orientation in its expanded configuration, the foreshortening effect or displacement of the region of the stent structure from the contracted configuration to the expanded configuration, or net displacement, may be controlled or limited by a change in the orientation of the transition wall 108, which transition wall 108 may displace the outer wall 106 toward the open end of the stent structure 100 and offset some other displacement of the outer wall, such that the reduced diameter intermediate portion of the outer wall generally remains in the contracted and expanded configurations. In some variations, the longitudinal offset in the reduced diameter intermediate portion of the outer wall when the stent structure expands may be less than 5 millimeters, 4 millimeters, 3 millimeters, 2 millimeters, or 1 millimeter.
The lateral strut sections may also feature a set of consecutive lateral strut sections that form part or all of a circumferential or perimeter strut around the wall of the stent structure. However, the lateral strut sections may vary more than just in their circumferential direction. To facilitate expansion and contraction of the entire stent structure, one or more lateral strut sections or all strut sections may include a pair of angled legs, each side end of each angled leg being formed continuously or integrally with the longitudinal strut section or strut, and wherein each angled leg is connected together centrally. While the curved configuration formed by the two angled legs may include a simple curve, in other examples, each leg may extend toward the center to form a hairpin-shaped curved region.
The leg angle formed between each leg and the longitudinal strut may vary in different regions of the brace structure and may vary depending on the leg length. In fig. 4A, an exemplary configuration of lateral strut sections in the inner wall of a stent structure is depicted. Due to the relatively low radial expansion exhibited by the inner wall as compared to the outer wall, the leg length of the inner wall is generally shorter than that found in the outer wall in the expanded configuration. Furthermore, due to the limited radial expansion, the legs in the inner wall may have a substantially linear configuration, as the structural strain created at the leg angle is limited. Referring to fig. 4B and 4C, in other regions of the stent structure, such as the outer wall and potentially the transition wall, where a greater amount of radial expansion is experienced, each leg may include a convex curvature along the acute leg and a concave curvature along the acute leg closer to the intermediate bend region.
In some embodiments, the lateral strut sections in the inner wall may include acute angle legs less than 50 degrees, 45 degrees, or 40 degrees, or in the range of 30-50 degrees, 35-45 degrees, or 35-40 degrees, while the acute angle legs in the outer wall may be in the range of 30-75 degrees, 30-60 degrees, 35-55 degrees, or 40-50 degrees. The longitudinal spacing between longitudinally adjacent lateral strut sections in the inner lumen may be less than the longitudinal spacing in the outer wall, for example, 2-8 mm, 3-7 mm, 4-6 mm, 2-6 mm or 3-5 mm, and 4-10 mm, 5-10 mm, 6-9 mm for the inner wall. The distance is also the length of the longitudinal strut sections in the respective wall regions.
Referring to fig. 1G, the orientations of the legs and intermediate bends of one or more sets of circumferential strut sections may also be offset radially outwardly relative to adjacent longitudinal struts to provide a barb-like or force concentrating structure to resist displacement of the strut structure relative to native valve tissue. The barbed lateral struts may be located anywhere along and/or around the outer wall of the stent structure, but in some variations may be located in the outer wall regions 142 and 144 between the reduced diameter region 142 and the outer opening 126 of the stent structure 100 and oriented toward the reduced diameter region 142. In some further examples, the radially outwardly displaced circumferential struts may be disposed at one or more circumferential struts closest to and directed toward the region of the outer wall having the smallest diameter. In a variation of a valve for mitral valve replacement, barbs may be formed in the struts to engage the sub-annular tissue on the ventricular side. In some examples, each lateral strut section in the circumferential strut is radially displaced, but in other examples, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or any range between any two of these numbers may be radially displaced, or every other or every third or every fourth lateral strut section may be radially displaced. The extent of projection from the outer wall shape defined by the plurality of longitudinal struts may be in the range of 2-10 mm, 2-6 mm or 2-4 mm. In some variations, the barb configuration is characterized by a ratio of a radial distance between the barb tip and the longitudinal axis of the stent structure to a radial distance between an adjacent longitudinal strut or outer wall section (excluding the barb) and the longitudinal axis of the stent structure. The ratio may be in the range of 1.1 to 1.5, 1.05 to 1.30, or 1.10 to 1.20.
In some further examples, control holes or attachment structures may be provided on the strut sections or at junctions between two or more strut sections. The control aperture may be used to releasably attach a tensioning member, including but not limited to sutures, wires, and hooks, which may be loosened or tensioned to control expansion, contraction, release, or loading of the stent structure during delivery of the prosthetic valve or loading of the prosthetic valve into its delivery system. Various embodiments of the delivery system and method are described in more detail below. Referring to the example in fig. 1E, control holes are optionally provided at the junction of the ends of each successive longitudinal strut in the outer and inner walls. Further, the control aperture may optionally be provided at an intermediate bend of one or both of the two circumferential struts closest to the outer opening 126 of the outer wall 106.
Fig. 4A schematically depicts one example of a strut configuration 400 that may be disposed on a region or wall of a stent structure. The strut configuration 400 includes longitudinal struts 402, 404 and lateral struts 406, 408. The longitudinal strut sections 402a, 404a and the lateral strut sections 406, 408 together form a closed perimeter of a stent opening or cell 410. For the purposes of characterizing the various geometric configurations of the strut configuration, longitudinal axis 410 and transverse axis 412 are described herein, but those skilled in the art will appreciate that other reference points or axes may be used. The longitudinal axis 410 is parallel to the longitudinal axis of the overall stent structure, while the transverse axis 412 is orthogonal to the longitudinal axis 410.
In the exemplary strut configuration 400 depicted in fig. 4A, the longitudinal struts 402, 404 may be parallel or non-parallel, depending on whether the lumen includes a cylindrical shape or a non-cylindrical shape, such as a frustoconical shape. In variations, where the longitudinal struts are non-parallel, the longitudinal struts 402, 404 may have a small radial angular orientation of about 1-5 degrees, 2-10 degrees, or 5-30 degrees with the longitudinal axis of the stent structure in order to provide a frustoconical shape. As shown in fig. 4A, the longitudinal and lateral struts 402, 404, 406, 408 may include strut sections 402a, 402b, 404A, 404b, 406a, 406b, 408a, 408b. In some variations, the inner wall 104 of the stent structure 100, the legs 406a, 406b, 408a, 408b of the lateral struts 406, 408 may comprise a generally linear or straight configuration, with deformation occurring primarily at the base 406c, 406d, 408c, 408d and the curved regions 406e, 408e of each lateral strut 406, 408. In some variations, where greater rigidity is required, the lateral struts are generally non-uniform along their length. This will be achieved by increasing the relative width near the base of the strut and decreasing the relative width in the middle portion of the strut. In this strut configuration 400, the acute angles 414a, 414b, 416a, 416b between the longitudinal struts 402, 404 and the legs 406a, 406b, 408a, 408b may be in the range of 1-45 degrees, 10-40 degrees, or 20-35 degrees. In some variations, the integrally formed intermediate regions of the paired legs may comprise a simple angular or curved configuration, but in other variations, curved regions 406e, 408e may be included, with the arch having a greater curvature 406f, 408f on the same side as the acute angle of the lateral strut, and a lesser curvature 406g, 408g found on the obtuse angle side of the lateral strut. The curved recess 406h, 408h of each curved region 406e, 408e includes a longitudinal length and a lateral width at a smaller curvature 406g, 408g. In some variations, these lengths and widths may be configured to assist in force distribution when the stent structure is contracted to its collapsed or delivery configuration. In some examples, the curved recess may include a longitudinal length in the range of 50-500 microns, 50-300 microns, or 50-250 microns, and a lateral width in the range of 50-500 microns, 50-350 microns, or 100-300 microns.
In some embodiments, the configuration of the orientation of the lateral struts with respect to the bending region and the relative configuration between the lateral struts and the longitudinal struts may vary. In the example strut configuration 400 in fig. 4A, both curved regions are toward the transition end or otherwise "pointed" toward the upstream end of the valve, but in other variations, the curved region or regions may be oriented toward the open or downstream end of the valve relative to the legs of the lateral struts.
Fig. 4B depicts another exemplary embodiment of a strut configuration 430 that includes longitudinal struts 432, 434 and lateral struts 436, 438. The longitudinal strut sections 432a, 434a and the lateral strut sections 436, 438 together form a closed perimeter of a stent opening or cell 440. Here, the legs 436a, 436b, 438a, 438b of the lateral struts 436, 438 may include a curved or curvilinear configuration in their expanded configuration. The legs 436, 438 have a generally convex configuration at their bases 436c, 436d, 438c, 438d and a concave configuration at their curved regions 436e, 438 e. In some variations, the male/female configuration allows for a greater amount of deployment from the delivery configuration to the expanded configuration, and/or more stress and strain may be distributed more along the entire length of the strut leg. The angle 444a, 444b, 446a, 446b between the longitudinal struts 432, 434 and the straight or intermediate portion of each leg 436i, 436j, 438i, 438j may be in the range of 25-135 degrees, 45-90 degrees, or 30-60 degrees. The bending region may also include bending recesses 436h, 438h having a longitudinal length and a lateral width, which may be configured to adjust the force and force distribution of the stent in its delivery and expanded configuration. One or more curved regions 436e, 438e of each lateral strut 436, 438 may also optionally include control apertures 436k, 438k as described elsewhere herein. In fig. 4B, the legs 436a, 436B, 438a, 438B and the curved regions 436e, 438e are also oriented in the same direction, but in fig. 4C, the legs 466a, 466B, 468a, 468B are oriented in opposite directions with the curved regions 466e, 468 e.
The continuous length of each strut section or of a longitudinal strut or lateral strut includes a lateral width or dimension, a radial height or dimension, and a cross-sectional shape. The shape may be generally square, rectangular, trapezoidal or other polygonal, circular or oval. The lateral width or dimension of each strut section may be configured to provide different levels of radial force, with a larger width providing a larger force and a smaller width providing a smaller force. In variations in which the stent structure is formed by laser cutting of a tubular base structure, the cross-sectional shape of the strut sections relative to their elongate length may comprise a segmented annular shape, as shown in fig. 2A-3B. In the particular exemplary embodiment of fig. 2A and 2B, struts 200a and 200B represent struts from the outer and inner walls, respectively, of the stent structure. The inner wall strut 200b comprises a segmented annular shape having a convex curvature 202b furthest from the longitudinal axis of the stent structure, i.e., a larger or longer curvature thereof, and a concave curvature 204b closer to the longitudinal axis of the stent structure, which is also a smaller or shorter curvature thereof, having side surfaces 206b, 208b that are generally linear in cross-section, but having angular axes 210b, 212b that are generally orthogonal to the longitudinal axis of the stent structure. The outer wall strut 200a may comprise the same or similar orientation as the inner wall strut 200b initially, but in embodiments where the outer wall is formed from eversion, the outer wall strut 200a will have an everting orientation such that its outer curvature 202a is concave relative to the longitudinal axis of the stent structure and is of a lesser curvature, while its inner curvature 204a, closer to the longitudinal axis of the stent structure, is convex and its greater curvature is concave (and is of a greater curvature). The side surfaces 206a and 208b have an angular orientation that is skewed relative to the longitudinal axis of the stent structure, e.g., the angular axes 210a, 212b of the side surfaces 206a, 208a do not intersect the longitudinal axis of the stent structure. These configurations are also notable in that they are located on different areas of the same longitudinal strut of the integrated folded stent structure formed by eversion. The corresponding transition wall struts will have a similar configuration in their deployed state as the outer wall struts 200a in the integrated folded stent structure formed by eversion.
Fig. 3A and 3B depict another embodiment of a folded stent structure in which there are a set of struts in the outer wall and inner wall that form lumens and walls due to the inversion of the laser cut tube, rather than the everting configuration depicted in fig. 2A and 2B. In fig. 3A and 3B, struts 300a and 300B represent struts from the outer and inner walls of the stent structure, respectively. The outer wall strut 300a includes a segmented annular shape having a convex curvature 302a furthest from the longitudinal axis of the stent structure, i.e., a larger or longer curvature thereof, and a concave curvature 304a closer to the longitudinal axis of the stent structure, also a smaller or shorter curvature thereof. The cross-section of the side surfaces 306a, 308a is generally linear, but has angular axes 310a, 312a that are generally oblique or non-intersecting with the longitudinal axis of the stent structure. The inner wall strut 300b may comprise the same or similar orientation as the outer wall strut 300a initially, but in embodiments where the inner wall is formed by inversion, the inner wall strut 300b will have an inverted orientation such that its outer curvature 302b is concave relative to the longitudinal axis of the stent structure and is of a lesser curvature, while its inner curvature 304b, which is closer to the longitudinal axis of the stent structure, is convex and its greater curvature is also concave. The side surfaces 306b and 308b have angular orientations that are skewed or non-intersecting with respect to the longitudinal axis of the stent structure. As with the everted configuration of the folded stent structure, these outer and inner wall configurations are located on different regions of the same longitudinal strut of the integrated folded stent structure formed by inversion. The corresponding transition wall struts will have a similar configuration in their deployed state as the outer wall struts 200a in the integrated folded stent structure formed by inversion. In some variations, the radial force generated in the outer wall by the inverted stent structure may be greater than by the everted stent structure, as the everting or inversion process may weaken or adversely affect the portion of the stent structure as compared to a portion that is not subjected to eversion or inversion.
The edges of the polygonal-shaped struts may be rounded, smooth or sharp. In fig. 2A and 2B, the corners 214a-220B include well-defined corner edges, while in fig. 3A and 3B, the corner edges 314a-320B include rounded corners. The rounded corners and edges may be formed using mechanical polishing, chemical polishing, electropolishing, or a multi-step combination thereof (e.g., mechanical polishing followed by chemical polishing or electropolishing). In some variations, the polishing may be performed prior to any inversion or eversion of the laser cut tube. The size and/or shape of the strut sections or struts may be uniform or may vary along their length. The radial thickness and/or circumferential width of the struts may be in the range of 300-500 microns, 360-460 microns, or 400-500 microns. The strut thickness and/or width may or may not be uniform along the length of the strut section. As previously described, in some examples, a relatively large width may be provided at the base of the circumferential strut section and a relatively small width may be provided around the intermediate bend region.
The spacing between adjacent longitudinal or circumferential struts may be equal throughout the folded stent structure or may vary along the folded stent structure. For longitudinal struts, the number of struts may be varied depending on the desired flexibility of the stent structure, or the desired radial deployment force, or based on the desired strut segment width, to achieve the desired radial deployment force or flexibility. For circumferential struts, a relatively larger spacing may be provided in areas where a larger radial deployment and/or a reduced deployment force is desired, and a smaller spacing may be provided in areas where a reduced radial deployment and/or a larger deployment force is desired.
The various stent structures described herein may include one or more of the following features
1) The net longitudinal stent length (i.e., the maximum distance spanned by the stent along the longitudinal axis) is in the range of 15-60 millimeters, 20-40 millimeters, or 25-35 millimeters;
2) The folded longitudinal support length (e.g., the longitudinal length of the end-to-end continuous longitudinal strut if fully straightened) is in the range of 40-100 millimeters; 50-90 mm; in the range of 60-80 mm;
3) The maximum stent diameter or transverse dimension in the expanded configuration is in the range of 20-80 millimeters, 30-60 millimeters, or 45-55 millimeters;
4) The maximum outer end diameter or transverse dimension in the expanded configuration is in the range of 25-75 millimeters, 35-65 millimeters, or 48-58 millimeters;
5) The maximum transition end diameter or maximum transition end transverse dimension in the expanded configuration is in the range of 20-80 millimeters, 25-55 millimeters, or 40-50 millimeters, and is optionally 0-20 millimeters, 1-15 millimeters, 2-10 millimeters, 2-8 millimeters, or 2-5 millimeters smaller than the maximum outer end or maximum stent diameter or transverse dimension;
6) The length of the inner cavity is in the range of 10-50 mm, 15-40 mm, or 20-26 mm;
7) The lumen diameter or maximum cross-sectional dimension is in the range of 10-40 millimeters, 15-35 millimeters, or 26-31 millimeters;
8) Radius of curvature R of the inner upper portion 1 In the range of 1-10 mm, 2-8 mm or 3-5 mm;
9) The inner upper bend angle is in the range of 0-180 degrees, 60-135 degrees, or 75-90 degrees, or 83 degrees;
10 A transition wall exterior angle relative to the longitudinal axis of the stent structure in the range of 0-180 degrees, 45-100 degrees, 75-90 degrees, or 90 degrees;
11 A transition wall radial width in the range of 5-30 millimeters, 5-20 millimeters, or 5-10 millimeters;
12 Radius of curvature R) of the outer upper portion 2 In the range of 0.5-6 mm, 1.5 to 5 mm or 2.5 to 4 mm;
13 Upper outer bending angle A) 2 In the range of 45-270 degrees, 90-235 degrees, 135-200 degrees, or 160-200 degrees;
14 A longitudinal length of the outer wall in the range of 10-40 mm, 20-35 mm or 25-30 mm;
15 The curve length of the outer wall is in the range of 10-50 mm, 20-50 mm or 30-40 mm;
16 A length of the outer wall longitudinal strut from the outer end to the transition wall in the range of 12-50 mm, 20-40 mm or 25-35 mm;
17 A radius of curvature of the intermediate region of the outer wall in the range of 1-15 mm, 3-12 mm, 4-8 mm or 3-6 mm;
18 The bending angle of the middle area of the outer wall is in the range of 10-180 degrees, 30-160 degrees, 60-160 degrees or 80-140 degrees;
19 Radius of curvature R of the open end region or lower region of the outer wall 4 In the range of 5-100 mm, 5-40 mm, mm or 10-20 mm;
20 Angle of curvature a of the open end region or lower region of the outer wall 4 In the range of 1-90 degrees, 10-90 degrees, 20-80 degrees, or 30-70 degrees;
21 A maximum radial difference between a minimum radius and a maximum radius in the same radial plane of the outer wall of the stent structure is in the range of about 6-15 millimeters, 8-12 millimeters, 9-11 millimeters, or about 10 millimeters;
22 A maximum radius of the first end/atrium/upper region of the outer wall in the range of 20-30 mm, 22-28 mm, or 24-27 mm;
23 A minimum radius of the middle region of the outer wall in the range of 10-30 mm, 12-25 mm or 15-20 mm;
24 A second end/ventricular/lower region of the outer wall having a maximum radius in the range of 20-35 mm, 25-30 mm, or 26-29 mm;
25 A ratio of longitudinal length to diameter in the range of 0.40 or 1.0, 0.45 to 0.80 or 0.50 to 0.60;
26 A plurality of longitudinal struts divisible by 3, for example selected from the group consisting of one or more of 3, 6, 9, 12, 15 longitudinal struts;
27 A ratio between a radial distance between the barb tip and the longitudinal axis of the stent structure and a radial distance between an adjacent longitudinal strut or outer wall section (excluding barbs) and the longitudinal axis of the stent structure is in the range of 1.1 to 1.5, 1.05 to 1.30, 1.05 to 1.20, or 1.05 to 1.15; and/or
28 An inner open position along the longitudinal axis relative to the outer open position that is positive (i.e., protruding from the outer opening), leveled (i.e., flush with the outer opening), negative (i.e., recessed from the outer opening), and/or within-4 mm to-12 mm, -5mm to-10 mm, -6mm to-9 mm, +1mm to +8mm, +2mm to +6mm, +3mm to +5mm, -3mm to +3mm; in the range of +0mm to +3mm, -12mm to +5mm, -6mm to +6mm, or-7 mm to +4 mm.
The scope of the scaffold described herein need not be limited so that each of the characteristics described above need to be selected, and individual characteristics or subsets of characteristics may also be considered. For example, in some variations, the stent structure, which may or may not be provided with valve and/or skirt material, may be:
1) A folded unitary stent structure having an everted outer wall strut configuration or an inverted inner wall strut configuration;
2) A folded one-piece stent structure and wherein the number of longitudinal struts is divisible by 3; having a non-shortened inner lumen, and optionally a shortened outer wall, having a radial strut thickness in the range of 400-450 microns, and a longitudinal length to diameter ratio in the range of 0.50-0.60;
3) The folding integral support structure comprises: an upper inner radius of curvature that is less than the upper outer radius of curvature; a lumen extending from 0 to 3 millimeters from the outer opening of the outer wall; and a ratio of the barb to the outer wall radius in the range of 1.1 to 1.2; or alternatively
4) The folded double-wall integrated stent structure has 12 longitudinal struts and 3-5 circumferential struts in the lumen, 1-2 circumferential struts in the transition wall and 3-5 circumferential struts in the outer wall.
In the fig. 1-1G embodiment, the stent structure 100 includes a plurality of end-to-end longitudinal struts and a plurality of circumferential lateral struts, each strut in turn including a set of consecutive longitudinal or lateral strut sections, respectively. In the specific example of the stent structure 100, twelve equally spaced end-to-end longitudinal struts are provided, as well as nine complete sets of circumferential struts along the folded stent structure 100. Four sets of closely spaced circumferential struts are provided along the inner wall with relatively straight or minimally curved legs, and their intermediate curved portions are oriented to point toward the upper or closed end of the stent structure. The transition wall 108 includes a set of circumferential struts having a relatively increasing base curvature in each leg and a relatively decreasing curvature about an intermediate bend oriented radially outwardly toward the outer wall 106. The outer wall 106 includes four sets of circumferential struts, the middle bends of which are oriented toward the closed end of the stent structure 100, except for the set of circumferential struts closest to the opening of the outer wall 106, which may be oriented toward the open end of the stent structure 100. The legs and intermediate bends in the third set of circumferential struts are also oriented to deviate radially outwardly relative to the adjacent longitudinal struts to provide a barb-like or force concentrating structure to resist displacement of the strut structure relative to the native valve tissue. Typically, these radially outwardly displaced circumferential struts may be disposed at one or more circumferential struts closest to the portion of the outer wall between the narrowest diameter and the downstream or open end of the stent structure and oriented toward the inlet/upstream end of the narrowest diameter or stent structure, as shown in fig. 1A and 1C.
As previously described, the control holes are also provided at the outer end of the stent structure 100 or at the junction of the longitudinal struts and the circumferential struts at the outer end of the stent structure 100 and at the inner end of the stent structure or at the junction of the longitudinal struts and the circumferential struts at the inner end of the stent structure, at the lumen. The control apertures are also provided at the intermediate bends of the two circumferential struts closest to the outer end of the stent structure 100.
For the stent structure 100, the net longitudinal stent length may be 25 to 35 millimeters, the folded longitudinal stent length may be 60-90 millimeters, the maximum stent diameter or lateral dimension in the expanded configuration may be 45-55 millimeters, the maximum outer end diameter or lateral dimension in the expanded configuration may be 45-55 millimeters, the maximum transition end diameter or lateral dimension in the expanded configuration may be 40-50 millimeters, and may be 1-5 millimeters less than the maximum outer end or maximum stent diameter or lateral dimension. The lumen length may be 20-25 millimeters, the lumen diameter or maximum cross-sectional dimension may be 20-30 millimeters, the inner upper radius of curvature may be 3-5 millimeters, the inner upper angle of curvature may be 90-105 degrees, the outer angle of the transition wall with respect to the longitudinal axis of the stent structure may be 75-90 degrees, the radial width of the transition wall may be 15-20 millimeters, the outer upper radius of curvature may be in the range of 1-4 millimeters, the outer upper angle of curvature may be 160-200 degrees, the outer wall longitudinal length may be 20-25 millimeters, the outer wall curvilinear length may be 25-40 millimeters, the length of the outer wall longitudinal strut from the outer end to the transition wall may be 25-35 millimeters, the radius of curvature of the outer wall intermediate region may be 3-6 millimeters, the outer wall intermediate region may be 60-120 degrees, the radius of curvature of the outer wall open end region or lower region may be 10-50 millimeters, 10-30 millimeters or 10-20 millimeters, the outer wall open end region or lower region may be 20-135 degrees, 30-70 degrees or 50-70 degrees. The maximum radial difference between the minimum radius and the maximum radius in the same radial plane of the stent structure may be 9-11 millimeters and/or the inner opening position along the longitudinal axis relative to the outer opening position may be negative-6 millimeters to-9 millimeters.
In fig. 1A-1F, the stent structure 100 also includes twelve continuous longitudinal struts and nine circumferential struts identical to the stent structure 100. The stent structure 100 includes four circumferential struts along the lumen 102, but in other variations there may be two, three, five, or six circumferential struts in the lumen. While the orientation of the circumferential struts in the inner wall 104 also points toward the closed end of the stent structure 100 and the circumferential struts of the transition wall 108 are oriented radially outward, in some variations one or more circumferential struts are oriented radially inward and/or toward the open end of the stent structure, e.g., the circumferential struts closest to the open end of the outer wall. Other alternative variations may include a transition wall having an orthogonal orientation relative to its longitudinal axis, while the transition wall 108 of the stent structure 100 is slight or substantially angled. The transition wall, which may be pushed out of the inward angle, may reduce turbulence or non-laminar flow into the opening of the lumen, or may reduce peak axial forces that move the stent structure away from the target site during atrial contraction.
In several embodiments described herein, the upper or transition end of the stent structure is configured to serve as the upstream end of the replacement valve, with blood flow received in the transition end of the inner lumen and passing through the valve structure attached to the inner lumen. The valve structure may be any of a variety of valve structures, including a valve, a balloon valve, or a leaflet valve. The leaflet valve material can include autologous, homologous or heterologous or artificial materials, such as natural materials or anatomical structures, e.g., porcine, bovine or equine pericardial tissue or valves, or biological materials derived from the patient's own cells, and can be immobilized with any of a variety of chemicals (e.g., glutaraldehyde) to reduce the antigenicity of the valve and/or alter the physiological and/or mechanical properties of the valve material. Where a leaflet valve is provided, the leaflet valve can be a bileaflet or trilobate valve structure. The attachment of the valve may be attached or sewn to the longitudinal and/or circumferential struts of the lumen, e.g., every fourth longitudinal strut of the stent structure 100 is provided with a tri-leaflet valve.
The replacement valve may also include one or more skirt materials leading to one or more regions of the stent structure. The skirt material may comprise a solid, tightly woven, or loosely woven autologous, homologous, or heterologous, or synthetic material, which may be the same as or different from the leaflet material of the valve. The skirt material may comprise Polytetrafluoroethylene (PTFE), polyester, or polyethylene terephthalate (PET) material. In variations including open cell materials, the average pore size may be in the size range of about 0.035 millimeters to 0.16 millimeters, or 0.05 millimeters to 0.10 millimeters, or 0.07 millimeters to 0.09 millimeters. The open cell material may provide greater elasticity or flexibility in regions of the scaffold structure that experience greater structural changes. Other areas of the stent may be provided with solid sheets without holes, which do not require elasticity or flexibility. The skirt material may comprise a single or multi-layer structure and include one or more coatings to regulate thrombosis, tissue ingrowth, and/or lubricity.
Fig. 5A-5C depict one example of a replacement valve 500 having a skirt 502 that includes two different materials attached to a stent structure 504. In this particular embodiment, a solid or tightly woven material is provided around the outer and inner surfaces of the downstream or lower region 508 of the outer wall 510 as the cuff structure 506. The same or different cuff structures of solid or tightly woven material are provided on the outer surface of the inner wall 512. Fig. 5C depicts a variation having a separate material for the inner wall 512, and fig. 5D depicts another variation having the same cuff structure spanning the annular cavity 522 and covering the outer surface of the inner wall 512. The porous knit material is used to surround the upper region 516 of the outer wall 510, the transition wall 518, and another cuff structure 514 to an upstream opening 520 of the inner wall 512 of the scaffold structure 504. Valve pockets and valve leaflets 516a-516c located in the interior chamber 512 can be formed using materials of artificial or animal origin. In addition to providing elasticity to expand as the stent structure expands, the porous knitted material may also provide cell migration and tissue ingrowth into the replacement valve. Such a dual material skirt 502 allows blood flowing into the annular cavity 522 to pass through the cuff structure 514 of the porous material, but the porous material may be provided with a porosity small enough to resist the passage of thrombus that may have formed.
In another variation depicted in fig. 6A-6D, skirt 600 comprises a tubular material. The shaped skirt 600 may provide a more consistent attachment of the skirt 600 to the stent structure with less potential for excess sheet material in the narrower stent region. In this particular variation, skirt 600 includes an inner central cavity 602 formed by an inner wall 604, and an inner annular cavity 606 between inner wall 604 and a shaped outer wall 608. The outer wall 606 may be shaped in a configuration complementary to the outer wall of the stent structure, such as an expanded upstream region 610, a reduced diameter intermediate region 612, and an expanded downstream region 614. The skirt 600 is placed over the closed end of the stent structure such that the stent structure is positioned in the annular cavity 606 and the inner wall 604 of the skirt 600 is positioned inside the lumen of the stent structure. In some variations, the inner wall 604 may be inverted into the lumen of the stent structure. A tapered annular skirt 616 may be provided to span the annular cavity 606 between the inner wall 604 and the shaped outer wall 608. The outer wall 608 of the skirt 602 may comprise a porous or knitted material that may be heat set into an expanded configuration and span the entire outer wall 606, transition wall 618 of the skirt 602, and optionally a portion of the inner wall 606, where it is stitched, adhered, and/or welded to a tubular tightly woven material configured to be arranged in the lumen of a stent structure. Tapered annular skirt 616 may also be stitched, adhesively welded or otherwise attached to the inner surface of outer wall 606 and the outer surface of inner wall 604 after outer wall 606 and inner wall 604 are initially assembled with the stent structure. Similarly, after the inner wall 604 is inserted into the lumen of the stent structure, the valve leaflet structure can be stitched, adhesively welded, or otherwise attached to the inner wall 604 of the skirt 600.
The skirt material may be sewn against the inner wall of the stent, the outer surface and/or the inner surface of the transition wall and/or the outer wall, and in some variations may be provided as a cuff or folded over the outer end, inner end or transition wall of the stent structure to span the inner and outer surfaces of the stent wall, or to transition from the inner or outer surface of one wall to the other wall, such as lining the annular cavity of the replacement valve, for example, to cover the inner surface of the outer wall, the inner surface of the transition wall, and the outer surface of the inner wall.
Fig. 7A and 7B are photographs of an exemplary replacement valve 700 with a dual material skirt as described above with respect to fig. 5A and 5B for use in mitral valve animal studies, implanted after 30 days. On the atrial side of the valve 700 shown in fig. 7A, tissue or cell ingrowth into the large pore knit fabric 702 and good ingrowth at the boundary or juncture between the large port knit fabric 702 and the tightly knit fabric is found, while on the ventricular side of the valve 700, which is primarily covered by the small pore tightly knit fabric 704 around the outer opening 706 and the inner opening 708, good tissue ingrowth is noted.
Manufacturing
In some variations, the stent structure may be fabricated using a superelastic nitinol tube that is laser cut with various slits and slots to obtain the initial tubular stent shape. Next, the tubular stent is expanded at least stepwise to the initial dimensions of the lumen of the stent structure during a series of cyclic deformation, heating and cooling steps. Then, the portions of the stent structure corresponding to the transition wall and the outer wall are further expanded stepwise to a desired diameter, and then turned stepwise outward using a mandrel to form the outer wall and gradually reduce the intermediate region of the outer wall, or further expansion of the upstream end region and the downstream end region of the outer wall is performed to obtain a diameter-reduced shape of the outer wall. In another step, one or more curved regions on the lateral struts surrounding the medial region are displaced radially outward to form a retention barb or structure.
In an alternative embodiment, after the initial cutting of the tube, the tube may undergo a series of cyclic deformation, heating and cooling steps to expand the tube in a stepwise manner at least to the initial dimensions of the outer lumen of the stent structure, and then the portions of the stent structure corresponding to the transition wall and the inner wall are turned into the outer wall to form the closed end and the inner wall. The outer wall may be further expanded or stepwise adjusted to the desired shape, for example by further expanding the open and closed end regions of the outer wall, or by reducing the cross-sectional size or diameter of the intermediate region. One or more curved regions on the lateral struts surrounding the medial region may also be displaced radially outward to form retention barbs or structures
Valve loading and delivery
As previously described, a plurality of control holes may be provided on the stent structure that may be used to attach one or more sutures to control the expansion and contraction of different regions on the stent structure, and/or one or more hooks to releasably retain the stent structure until final deployment at the treatment site. In other examples, instead of using control holes, sutures or wraps may be provided on the exterior of one or more regions of the stent structure.
In some embodiments, the suture may be tightened or cinched to collapse the outer and inner walls of the stent structure for loading onto the delivery catheter. The suture may be manipulated to first collapse the inner wall before the outer wall, or both may be collapsed at the same time. Similarly, one end of the inner or outer wall may collapse first, or both ends of the inner or outer wall may collapse simultaneously. This can be done at the point of use or at the point of manufacture at room temperature, or in a sterile cold or ice water bath. After collapsing, the sheath may extend distally over the distal catheter portion where the replacement valve is located. The valve may also be rinsed in sterile saline prior to loading to remove any preservative remaining on the valve.
In some variations, the transition wall of the stent structure is folded down at the inner junction such that in the collapsed configuration the transition wall is positioned directly over the delivery catheter or tool like the inner wall, but in other examples the outer wall is pulled distally during collapse and loading and the transition wall is unfolded at the outer junction, e.g., the transition wall is radially outward of the inner wall when collapsed to the folded configuration.
The retaining suture of the delivery system may be controlled proximally by a user using a pull ring, a sliding bar, and/or a rotating knob that is also configured to lock in place other than during movement by a biasing spring or a mechanical inter-fit locking arrangement as is known in the art. The proximal end of the delivery system may also be robotically controlled using any of a variety of robotic catheter guidance systems known in the art. In addition to any irrigation lumen, guidewire lumen, or steering wire lumen provided (including rapid exchange guidewire configurations), the suture may be slid along one or more lumens of the delivery catheter. The suture may exit at different locations around the distal region of the delivery catheter and may exit around the distal region of the catheter through a plurality of openings. The plurality of openings may be spaced around the circumference of the catheter body and/or longitudinally, depending on the region of the stent structure controlled by the suture.
In one exemplary method of delivering a replacement valve, a patient is positioned on an operating table and covered and sterilized in the usual manner. Anesthesia or sedation is achieved. Percutaneous access or access to the femoral vein is obtained and an introducer guidewire is inserted. The guidewire is maneuvered to the right atrium, and then a buckeybucco needle (Brockenbrough needle) is placed and used to puncture the atrial septum to access the left atrium. Alternatively, image guidance may be used to detect the presence of an patent foramen ovale septum or residual passage, and a guidewire may be passed through the pre-existing anatomical opening. Balloon catheters may also be used as needed to enlarge the opening through the atrial septum. Electrocautery catheters may also be used to create openings in the atrial septum. After entering the left atrium, the guidewire passes through the mitral valve and into the left ventricle. A preformed guide catheter or balloon catheter may be used to facilitate crossing of the mitral valve. After entering the left ventricle, a delivery catheter with a replacement valve is inserted over the guidewire.
Referring to fig. 8A, a delivery system 800 having a delivery catheter 802 and a valve 804 is positioned through a mitral valve opening 806. The delivery system 800 may be further manipulated to adjust the angle of entry through the mitral valve opening 806 such that it is generally orthogonal to the native valve opening and/or centered with the mitral valve opening 806. Once the desired catheter pose is reached, the delivery sheath 808 is proximally withdrawn to expose the collapsed valve 804.
In fig. 8B, a set of sutures at the downstream or ventricular end 810 of the outer wall 812 of the control release valve 804 are partially released, while the tensioning members of the control inner wall 816 remain tensioned. Next, in fig. 8C, the ventricular end 810 of the outer wall 812 of the valve 804 is further released, allowing the ventricular end, the middle region, and more atrial end 814 of the outer wall 812 to expand further, allowing the transition wall 816 of the valve 802 to expand at least partially outward. The partial expansion of the atrial end 814 and the ventricular end 810 of the valve 802 helps to further orthogonally center and orient the middle region 822 of the valve 802 prior to full release. While in this embodiment the initial expansion of the atrial end 814 of the outer wall 812 is a secondary effect of partially releasing the ventricular end 810 of the valve 802 as the longitudinal tension members are released, in other examples, separate tension members controlling the atrial end 814 may be provided.
In fig. 8D, the tension members of the ventricular end 810 and the atrial end 814 are further simultaneously or individually released in a stepwise manner, thereby further engaging the intermediate region 820 of the outer wall 812 against the valve opening 806. This further expansion of the outer wall 812 also exposes retention barbs or protrusions 822 on the outer wall 812. The correct centering and orientation of the valve is re-confirmed to ensure that the valve is not deployed in a skewed or partially disengaged position relative to the mitral valve annulus. In some variations, re-tensioning the tensioning members may be performed to re-collapse (fold) the valve 804, thereby facilitating repositioning and/or reorientation of the valve 804. Once confirmed, the tensioning member of the inner wall 818 may be released, as shown in fig. 8E, which also allows the outer wall 812 to achieve its unconstrained deployment against the mitral valve opening 806. The tensioning member may then be cut or otherwise released or detached from the valve, and the tensioning member may be withdrawn into the catheter and optionally out the proximal end of the catheter. The delivery catheter and guidewire may then be withdrawn from the patient and hemostasis achieved at the femoral vein site.
In one exemplary method of delivering a replacement valve, a patient is positioned on an operating table and covered and sterilized in the usual manner. Anesthesia or sedation is achieved. Percutaneous or severed access to the blood vessel or access site (e.g., at the femoral vein, femoral artery, radial artery, subclavian artery) is obtained and an introducer guidewire is inserted. The guidewire is maneuvered to reach the desired valve implantation site. A preformed guide catheter or balloon catheter may be used to facilitate crossing of the valve implantation site.
Referring to fig. 8A, a delivery system 800 having a delivery catheter 802 and a valve 804 is positioned through a valve opening 806. The delivery system 800 can be further manipulated to adjust the angle of entry through the valve opening 806 to be generally orthogonal to the native valve opening and/or centered with the valve opening 806. Once the desired catheter pose is reached, the delivery sheath 808 is proximally withdrawn to expose the collapsed valve 804.
In fig. 8B, a set of tensioning members controlling the downstream end 810 of the outer wall 812 of the release valve 804 are partially released, while the tensioning members controlling the inner wall 816 remain tensioned. Next, in fig. 8C, the downstream end 810 of the outer wall 812 of the valve 804 is further released, allowing the downstream end of the outer wall 812, the intermediate region, and more of the upstream end 814 to expand further, allowing the transition wall 816 of the valve 802 to expand at least partially outwardly. The partial expansion of the atrial end 814 and the ventricular end 810 of the valve 802 helps to further orthogonally center and orient the middle region 822 of the valve 802 prior to full release. While in this embodiment the initial expansion of the atrial end 814 of the outer wall 812 is a secondary effect of partially releasing the ventricular end 810 of the valve 802 as the longitudinal tension members are released, in other examples, separate tension members controlling the upstream end 814 may be provided.
In fig. 8D, the tensioning members of the downstream end 810 and the upstream end 814 are further simultaneously or individually released in a stepwise manner, thereby further engaging the intermediate region 820 of the outer wall 812 against the valve opening 806. This further expansion of the outer wall 812 also exposes retention barbs or protrusions 822 on the outer wall 812. The proper centering and orientation of the valve is reconfirmed to ensure that the valve is not deployed in a skewed or partially disengaged position relative to the valve annulus. Optionally, re-tensioning the tensioning members may be performed to re-collapse (fold) the valve 804, thereby facilitating repositioning and/or reorientation of the valve 804. Once confirmed, the tension members of the inner wall 818 are released, as shown in fig. 8E, which also allows the outer wall 812 to achieve its unconstrained deployment against the mitral valve opening 806. The tensioning member may then be detached from the valve 804 and withdrawn into the catheter and optionally out the proximal end of the catheter 802.
In yet another exemplary method of delivering a replacement valve, a patient is positioned on an operating table and covered and sterilized in the usual manner. Anesthesia or sedation is achieved, and the right lung and optionally the upper left lung lobe are selectively ventilated to allow collapse of the lower left lung She Shoukong. A purse string suture (purestrangsuture) is placed over the apex of the heart or other heart access site. The trocar is inserted through a cannula or introducer having a proximal hemostatic valve and the trocar assembly is inserted through a purse string suture to access the heart chamber and the target valve.
Referring to fig. 8A, a delivery system 800 having a delivery rigid tool 802 and a valve 804 is positioned over a valve opening 806. The delivery system 800 can be further manipulated to adjust the angle of entry through the valve opening 806 to be generally orthogonal to the native valve opening and/or centered with the valve opening 806. Once the desired tool pose is reached, the delivery sheath 808 (if any) is proximally withdrawn to expose the collapsed valve 804.
In fig. 8B, the tensioning member of the downstream end 810 of the outer wall 812 of the control release valve 804 is partially released, while the sutures of the control inner wall 816 remain tensioned. Next, in fig. 8C, the downstream end 810 of the outer wall 812 of the valve 804 is further released, allowing the downstream end of the outer wall 812, the intermediate region, and more of the upstream end 814 to expand further, allowing the transition wall 816 of the valve 802 to expand at least partially outwardly. The partial expansion of the atrial end 814 and the ventricular end 810 of the valve 802 helps to further orthogonally center and orient the middle region 822 of the valve 802 prior to full release. While in this embodiment the initial expansion of the atrial end 814 of the outer wall 812 is a secondary effect of partially releasing the ventricular end 810 of the valve 802 as the longitudinal tension members are released, in other examples, separate sutures may be provided to control the atrial end 814.
In fig. 8D, the tensioning members of the downstream end 810 and the upstream end 814 are further simultaneously or individually released in a stepwise manner, thereby further engaging the intermediate region 820 of the outer wall 812 against the valve opening 806. This further expansion of the outer wall 812 also exposes retention barbs or protrusions 822 on the outer wall 812. Optionally, re-tensioning the tensioning members may be performed to re-collapse (fold) the valve 804, thereby facilitating repositioning and/or reorientation of the valve 804. The proper centering and orientation of the valve is reconfirmed to ensure that the valve is not deployed in a skewed or partially disengaged position relative to the valve annulus. Once confirmed, the tension members of the inner wall 818 are released, as shown in fig. 8E, which also allows the outer wall 812 to achieve its unconstrained deployment against the mitral valve opening 806. The suture may then be cut and the cut end withdrawn into the catheter and optionally withdrawn from the proximal end of the delivery tool 802.
While embodiments herein have been particularly shown and described with reference to embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the embodiments. For all of the above embodiments, the steps of the method need not be performed sequentially.

Claims (18)

1. A replacement heart valve, comprising:
an integrated stent frame having folded double walls, the stent frame comprising:
a collapsed configuration and an expanded configuration;
an outer wall comprising an open expanded diameter region, a middle reduced diameter region, and a closed expanded diameter region;
a tubular inner wall having a central lumen; and
a transition wall between the outer wall and the inner wall; and
a replacement leaflet valve positioned within the central lumen of the inner wall.
2. The valve of claim 1, wherein the integrated stent frame further comprises a first fold between the enclosed expanded diameter region and the tubular inner wall.
3. The valve of claim 2, wherein the unitary stent frame comprises a second fold between the closed expanded diameter region and the open expanded diameter region.
4. The valve of claim 1, wherein the outer wall surrounds at least 70% of the inner wall in the expanded configuration.
5. The valve of claim 4, wherein the outer wall and the transition wall completely surround the inner wall in the collapsed configuration.
6. The valve of claim 1, wherein the tubular inner wall comprises a non-foreshortened region surrounding the replacement valve when transitioning from the collapsed configuration to the expanded configuration.
7. The valve of claim 1, wherein the inner wall is a non-foreshortened inner wall and the outer wall is a foreshortened outer wall.
8. The valve of claim 3, wherein a radius of curvature at the first fold is less than a radius of curvature at the second fold.
9. The valve of claim 1, wherein the integrated stent frame further comprises a plurality of longitudinal struts, wherein each longitudinal strut is positioned continuously along the inner wall, the transition wall, and the outer wall.
10. The valve of claim 9, wherein for at least one of the plurality of longitudinal struts, consecutive sections of the longitudinal struts in the inner wall, the transition wall, and the outer wall are coplanar.
11. The valve of claim 9, wherein the continuous section of the longitudinal struts are also coplanar with a central longitudinal axis of the unitary stent frame.
12. The valve of claim 9, wherein the plurality of longitudinal struts are integrally formed with a plurality of circumferential struts.
13. The valve of claim 12, wherein at least three circumferential struts are located in the outer wall.
14. The valve of claim 1, further comprising a stent cover comprising:
a first region on an outer surface of the outer wall;
a second region on the open end of the outer wall;
a third region on an outer surface of the transition wall;
a fourth region on the inner surface of the inner wall;
a fifth region on the open end of the inner wall;
a sixth region on the outer surface of the inner wall;
a seventh region on an inner surface of the outer wall; and
an eighth region portion between the inner surface of the outer wall and the outer surface of the inner wall.
15. The valve of claim 14, wherein:
a portion of the first, second, third, and fourth regions comprise a first textile structure;
a portion of the fourth region and the fifth region comprise a second textile structure; and
The sixth region, the seventh region, and the eighth region comprise a third textile structure.
16. The valve of claim 15, wherein the first and third fabric structures comprise a first fabric material and the second fabric structure comprises a second fabric material different from the first fabric material.
17. The valve of claim 16, wherein the first fabric material is less permeable and thinner than the second fabric material.
18. The valve of claim 12, wherein the plurality of longitudinal struts and the plurality of circumferential struts comprise a segmented annular cross-sectional shape, and wherein an orientation of the segmented annular cross-sectional shape in the inner wall is opposite an orientation of the segmented annular cross-sectional shape in the outer wall.
CN202180088000.XA 2020-10-28 2021-10-27 Systems, devices, and methods for a folded integrated heart valve stent Pending CN116710027A (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202063106871P 2020-10-28 2020-10-28
US63/106,871 2020-10-28
US17/083,266 2020-10-28
PCT/US2021/056915 WO2022094001A1 (en) 2020-10-28 2021-10-27 Systems, devices and methods for folded unibody heart valve stents

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CN116710027A true CN116710027A (en) 2023-09-05

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