Systems, devices, and methods of replacement valves including integral stent structures

Abstract

Embodiments herein relate to a replacement valve comprising a double-walled folded stent structure having an inner wall providing a lumen and a valve structure attached to the stent structure. The inner wall is spaced from the outer wall that is configured to seal and / or anchor to a surrounding native valve anatomy but is connected to the inner wall by a transition wall. The transition wall may be formed by folding, inverting or everting a single tubular structure into a double-wall integral tubular stent structure. The stent structure is configured to be reversibly folded into a contracted configuration exhibiting a reduced diameter or reduced cross-sectional shape for loading into a catheter and delivery to a target anatomical site, and an expanded configuration.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application obtains the benefit of U.S. Provisional Patent Application No. 63 / 350,207, filed on June 8, 2022, pursuant to the requirements of Section 119(e) of Title 35 of the United States Code, the entire contents of which are incorporated herein by reference. Background Art

[0003] The present patent application relates generally to the treatment of valvular disease and, more particularly, to methods and apparatus for minimally invasive tricuspid valve replacement.

[0004] Valvular heart disease is a significant burden on patients and healthcare systems, with a global prevalence of 2-3% and increasing prevalence in the elderly population. Valvular disease is usually caused by cardiovascular causes, such as myocardial infarction and heart failure, but can also be caused by a variety of etiologies, including autoimmune, infectious, and degenerative causes. The etiology of valvular disease also varies depending on the valve affected. For example, tricuspid regurgitation can be caused by congenital disease, infective endocarditis or rheumatic fever, iatrogenic events (such as injury from pacemaker leads or endomyocardial biopsy), Marfan syndrome, and other problems. Summary of the invention

[0005] The further development of transcatheter tricuspid valve therapy is challenged by the difficult anatomy and physiology of the tricuspid valve compared with the more established transcatheter aortic and mitral valve therapies. For example, the tricuspid valve and its surrounding anatomy are not as strong as those of the aortic and mitral valves, making it difficult to secure the replacement valve to the tricuspid valve.

[0006] To address these issues, embodiments described herein relate to a replacement heart valve comprising an integral, folded double-walled stent having a stent cover and a valve structure (e.g., a leaflet valve) attached to the stent lumen. The double-walled stent structure decouples or reduces the effects of the geometry of the valve support geometry retaining structure. This includes external forces acting through the valve annulus during the cardiac cycle, as well as the effects of non-circular valve annulus shapes. The double-walled stent structure also allows the valve support to have a different size and shape from the outer ring support, without the valve support having to expand or deform relative to the natural anatomical structure, or at least partially isolating the effects of the outer ring support expansion relative to the anatomical structure. The integral design can also achieve greater structural integrity by reducing the complexity associated with the force concentration between the joined, welded or mechanically connected support components and / or their in-situ connectors.

[0007] In one embodiment, a replacement heart valve is disclosed. The replacement heart valve includes an integrated stent structure. The stent structure includes a contracted configuration and an expanded configuration. The stent structure also includes an outer wall, which includes an area of ​​increased diameter and an area of ​​reduced diameter. In addition, the stent structure includes an inner wall defining an inner cavity and a transition wall between the outer wall and the inner wall. The replacement heart valve also includes a valve structure located in the inner cavity of the inner wall. The integrated stent structure also includes a plurality of longitudinal struts and a plurality of lateral struts formed together, each longitudinal strut being continuously positioned along the inner wall, the transition wall and a portion of the outer wall. The outer wall may have a generally open or frustoconical shape, wherein the diameter of the latter is located at an end opposite to the transition wall. The inner wall may have a generally cylindrical shape. For embodiments including a replacement tricuspid valve, the longitudinal struts may be provided in multiples of three, for example, a total of three, six, nine or twelve longitudinal struts. In some variations, the longitudinal struts extend along the entire length of the inner wall, the length of the transition wall and the entire length of the outer wall. However, in other variations, the longitudinal struts extend only partially along the length of the outer wall. The length of the longitudinal strut segments in the outer wall may be shorter, the same, or longer than the length of the longitudinal strut segments in the inner wall. When the inner wall and the transition wall may include longitudinally non-shortened structures, the outer wall may be partially longitudinally shortened and non-shortened, the non-shortened portion being connected to the transition wall and the shortened portion being located at the free end of the outer wall. Radially extending anchor struts may also be provided. The anchor struts may be curved radially outwardly and may be located at the shortened portion of the outer wall.

[0008] In one embodiment, a replacement heart valve is provided, comprising an integral support structure including a collapsed configuration and an expanded configuration, an outer wall including an area of ​​increased diameter and an area of ​​reduced diameter, an inner wall defining an inner cavity, a transition wall between the outer wall and the inner wall, and a valve structure located in the inner cavity of the inner wall, wherein the integral support further comprises a plurality of longitudinal struts and a plurality of lateral struts formed together, each longitudinal strut being continuously positioned along the inner wall, the transition wall, and a portion of the outer wall, wherein the ratio of the axial length of a portion of the outer wall without any of the plurality of longitudinal struts to the axial length of a portion of the outer wall with at least some of the plurality of longitudinal struts is in the range of 1:1 to 1:1.5. The valve may be a tricuspid replacement valve. The transition wall may be located downstream of the area of ​​increased diameter. The outer wall may include a first area extending from the transition wall and a second area extending from an open end of the outer wall, the first area including a plurality of longitudinal struts and the second area not having a plurality of longitudinal struts. The first area may include at least one of the plurality of lateral struts, the second area may include at least one of the plurality of lateral struts, the at least one of the plurality of lateral struts of the first area presenting a strut configuration different from at least one of the plurality of lateral struts of the second area. At least one of the plurality of lateral struts in the first region includes a leg in a generally linear relationship, and each leg is deformed near the end, and wherein at least one of the plurality of lateral struts in the second region includes a leg in a generally S-shaped or combined concave / convex shape. At least a portion of the first region of the outer wall can be configured to be disposed in a ventricle of the heart, and at least a portion of the second region of the outer wall can be configured to be disposed in an atrium of the heart. The second region of the outer wall can be configured to be softer than the first region of the outer wall. The outer wall can include a plurality of barbs extending therefrom. The outer wall can include a first region extending from a transition wall and a second region extending from an open end of the outer wall, the first region including a plurality of longitudinal struts, the second region not having a plurality of longitudinal struts, and wherein a plurality of barbs extend from the second region of the outer wall. The plurality of barbs can be more toward the outer opening of the outer wall than toward the transition wall. The plurality of longitudinal struts and the plurality of lateral struts can include nitinol. The replacement heart valve can also include a skirt material disposed on at least a portion of the outer wall, at least a portion of the inner wall, and at least a portion of the transition wall. The skirt material can include a first material and a second material different from the first material. The first material may include a weave material, and the second material may include a knit material. The weave material may be disposed on at least a portion of the inner wall and at least a portion of the outer wall extending from the outer opening of the outer wall, a portion of the weave material extends between the inner wall and the outer wall, and wherein the knit material is disposed on at least a portion of the transition wall and a portion of the outer wall extending from the transition wall. A portion of the weave material extending between the inner wall and the outer wall may extend through the outer opening. A portion of the weave material extending between the inner wall and the outer wall may extend through an intermediate position spaced apart from the outer opening.The outer wall may include a plurality of barbs extending therefrom, and the skirt material may include a plurality of openings formed therein, each of the plurality of openings being configured to receive one of the plurality of barbs. The skirt material may include one or more wire openings formed therein configured to allow one or more electrical wires to pass therethrough. A ratio of an axial length of a portion of the outer wall without any of the plurality of longitudinal struts to an axial length of a portion of the outer wall with at least some of the plurality of longitudinal struts may be in the range of 1:1.0 to 1:1.4. An inflow angle between an inlet of the outer wall and an inlet of the inner wall may be in the range of 5 degrees to 35 degrees, or in the range of 25 degrees to 35 degrees. A ratio between a diameter of the inner wall and a diameter of the outer wall at an end point of at least one of the plurality of longitudinal struts may be in the range of 1:1 to 1:2. A replacement heart valve according to claim 24, wherein a ratio between a diameter of the inner wall and a diameter of the outer wall at an end point of at least one of the plurality of longitudinal struts may be in the range of 1.4 to 1.6. The average radius of curvature of the transition wall may be in the range of about 1 mm to 5 mm, or in the range of about 1.5 mm to 3 mm. The ratio of the axial dimension of the inner wall and the transition wall combined to the axial dimension of the outer wall and the transition wall combined may be in the range of about 1:1 to 1:1.5, or in the range of about 1.1 to 1.3. The ratio of the axial dimension of the inner wall to the axial dimension of the outer wall may be in the range of about 1:05 to 1:1.4, or in the range of about 1.1 to 1.3. The ratio between the diameter of the outer wall including at least one end of the plurality of longitudinal struts and the maximum diameter of the outer wall may be in the range of 1:1 to 1:1.5, or in the range of 1:1.2 to 1:1.4. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1A is a partial schematic side view of an embodiment of a support structure, wherein the rear half of the support structure is omitted; Figure 1B is a schematic top plan view of the support structure; Figure 1C yes Figure 1A A partial cross-sectional view of an inner support structure without an outer wall; Figure 1D is a partial schematic side view of the outer wall of the support structure without the inner wall; and Figure 1E yes Figure 1A A schematic component diagram of two longitudinal struts; Figures 1F to 1I yes Figure 1A Isolated cross-sectional side profile views of a stent structure depicting various exemplary dimensions of the stent structure.

[0010] Figure 2A and 2B Various exemplary strut configurations are depicted;

[0011] Figure 3is a schematic cross-sectional view of a replacement valve having a skirt material attached to a stent structure according to an embodiment;

[0012] Figure 4 is a schematic cross-sectional view of a replacement valve having a skirt material attached to a stent structure according to an embodiment;

[0013] Figure 5 is a schematic isometric view of a replacement valve having a skirt material defining one or more guidewire openings according to an embodiment;

[0014] Figure 6 is a schematic isometric view of a replacement valve with a valve structure according to an embodiment; a side view of another embodiment of a heart valve stent with a leaflet valve and a skirt attached;

[0015] Fig. 7A and 7B is a schematic cross-sectional illustration of an exemplary view of a deployment procedure for a heart replacement valve and delivery system. DETAILED DESCRIPTION

[0016] Embodiments herein relate to a replacement valve comprising a double-walled folded stent structure having an inner wall providing an inner cavity and a valve structure attached to the stent structure. The inner wall is spaced apart from the outer wall, and the outer wall is configured to seal and / or anchor to the surrounding native valve anatomical structure, but is connected to the inner wall by a transition wall. The transition wall can be formed by folding, inverting or everting a single tubular structure into a double-walled one-piece tubular stent structure. The stent structure is configured to reversibly fold into a contracted configuration and an expanded configuration, and the contracted configuration presents a reduced diameter or a reduced cross-sectional shape for loading into a catheter and delivering to a target anatomical site.

[0017] In a further embodiment, the outer wall of the stent structure can be formed to have an area of ​​increased diameter and an area of ​​reduced diameter located downstream of the area of ​​increased diameter. The area of ​​increased diameter and the area of ​​reduced diameter can facilitate anchoring of the stent structure at a desired anatomical site. The area of ​​reduced diameter is configured to expand against the native valve leaflets and / or anatomical orifice, while the area of ​​increased diameter provides mechanical interference or resistance to displacement. Mechanical and / or frictional interference can anchor the stent structure to the anatomical structure and form a seal to prevent fluid from flowing between the stent structure and the anatomical structure. In one embodiment, the outer wall does not include an additional area of ​​increased diameter downstream of the area of ​​reduced diameter, as the additional area of ​​increased diameter may interfere with the chordae tendineae of the tricuspid valve or other anatomical structures.

[0018] Although some of the exemplary embodiments described herein relate to transcatheter replacement of the tricuspid valve, the components and structures herein are not limited to any particular valve or delivery method and may be suitable for implantation in the tricuspid valve, pulmonary artery, aortic valve locations, or in non-cardiac locations (e.g., the aorta, venous system, or cerebrospinal fluid system, or a natural or artificial catheter, conduit, or shunt). As used herein, spatial reference to the first or lower end of a component may also be characterized by the anatomical space occupied by the component and / or the relative direction of fluid flow. For example, the first or lower end of a replacement tricuspid valve stent structure may also be referred to as the ventricular end or downstream end of the valve, while the opposite end (e.g., the second or upper end) may be referred to as the atrial end or upstream end.

[0019] Figures 1A to 1E An exemplary embodiment of a stent structure 100 is shown in FIG. 1 , wherein the stent structure 100 is in its expanded configuration. For illustrative reasons, the stent structure 100 is omitted to simplify the description of the stent structure. Figure 1A , 1C 1D and the rear half of the stent structure 100 shown. The stent structure 100 includes an inner cavity 102 formed by an inner wall 104. The outer wall 106 is radially spaced from the inner wall 104 via a transition wall 108 and forms an annular cavity 110. The stent structure 100 has a first closed end 112 located 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 stent structure 100 can present a unitary structure (e.g., formed from a single piece), which provides structural integrity to the stent structure 100 and better redistributes forces acting on the stent structure 100, which are generally found to be less concentrated in stent structures including multiple components.

[0020] The lumen 102 includes a first opening 116 surrounded by a transition wall 108 and a second opening 118 located at the second open end 114 of the support structure 100. The longitudinal axis 120 of the lumen 102 generally coincides with the central axis of the support structure 100, but in some variations, the lumen 102 may be located off-center relative to the outer wall 106 of the support structure 100. 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, such as Figures 1A-1C In other examples, the inner cavity 102 may include a frustoconical, elliptical, or polygonal shape. In some variations, the support structure 100 may include an inner cavity in which the size and / or shape of the first opening 116 and the second opening 118 may be different. See Figure 1F, the length 150 of the inner cavity 102 can be measured from the first opening 116 to the second opening 118 and can be in the range of 10mm to 50mm, 15mm to 40mm, 20mm to 25mm, 15mm to 20mm, 17.5mm to 22.5mm, 20mm to 25mm, 22.5mm to 27.5mm, 25mm to 30mm, 27.5mm to 32.5mm, 30mm to 35mm, 32.5mm to 27.5mm, or about 35mm to 40mm, or 22 to 27mm, and the diameter 152 or maximum cross-sectional dimension of the inner cavity 102 can be in the range of 15mm to 40mm, 15mm to 25mm, 20mm to 30mm, 25mm to 35mm, or 27mm to 32mm. In embodiments where the lumen 102 comprises a non-cylindrical shape, the difference between the diameter or cross-sectional dimensions of the first opening 116 and the second opening 118 may be in a range of 1 mm to 10 mm, 1 mm to 5 mm, or 1 mm to 3 mm.

[0021] Maximum length L I The valve can be selected based on the size of the anatomy and is selected to be large enough to allow for the valve structure (for a more detailed discussion see Figure 6 ) to function within lumen 102. However, in some variations, it may be generally desirable to minimize maximum length 150 to limit the length of stent structure 100 when stent structure 100 is in the collapsed configuration, thereby making it easier to insert stent structure 100 into a desired anatomical structure. In addition, since the portion of stent structure 100 disposed in the ventricle may interfere with the ventricle, it may be desirable to minimize maximum length 150 to reduce the length of stent structure 100 disposed in the ventricle.

[0022] The positions of the first opening 116 and the second opening 118 of the lumen 102 relative to the overall 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, such as Figure 1A and 1EAs shown. In other examples, the first opening 116 can be substantially flush with the first end 112 of the transition wall 108 of the support structure 100. The position of the first opening 116 can also be characterized as being recessed, flush, or protruding relative to the longitudinal position of the inner wall 104 or the internal joint 122 between the inner cavity 102 and the transition wall 108, or relative to the external joint 124 between the transition wall 108 and the outer wall 106. Similarly, the second opening 118 of the inner cavity 102 can also be characterized as being recessed, flush, or protruding relative to the longitudinal position of the outer opening 126 of the outer wall 106. For example, the second opening 118 of the inner cavity 102 includes an offset or protruding position relative to the outer opening 126 of the outer wall 106. In some variations, the inner cavity 102 can protrude relative to the outer opening 126 of the outer wall 106, wherein a smaller or shorter outer wall 106 is preferred to accommodate a smaller size of the native valve anatomy. However, the dimensions of lumen 102 may remain relatively the same size between the different size variations to provide consistent valve geometry and / or hemodynamic characteristics.

[0023] The transition wall 108 of the stent structure 100 has a generally annular and circular shape (e.g., concave or convex) surrounding the lumen 102 in the expanded configuration, but may have different shapes and / or surface angles in other variations. For example, the transition wall 108 in cross-section may include a circular (e.g., semicircular) shape between the inner joint 122 and the outer joint 124, but may include a generally linear shape (e.g., at a generally orthogonal angle relative to the longitudinal axis 120 of the lumen 102) in other variations. See Figure 1E , the transition wall 108 of the support structure 100 may have an average curvature radius R T The average radius of curvature R T It may be in the range of 0.5mm to 1.5mm, 1mm to 2mm, 1.5mm to 2.5mm, 1.5mm to 2mm, 1.5mm to 3mm, 2mm to 3mm, 2.5mm to 3.5mm, 1mm to 5mm or 3mm to 4mm.

[0024] See also Figure 1F, without the barbs 146, the maximum diameter 160 of the outer wall 106 in its maximum expanded configuration, which is the diameter of the entrance or outer opening of the outer wall 106, can be in the range of 40mm to 80mm, 45mm to 70mm, 50mm to 70mm, 55mm to 65mm, or 58mm to 62mm. Including the distal ends of the barbs 146, the maximum diameter 162 of the outer wall 106 in its maximum expanded configuration can be in the range of 40mm to 80mm, 50mm to 75mm, 55mm to 65mm, 60mm to 65mm, or 60mm to 70mm. The minimum diameter 164 of the outer wall 106 in its maximum expanded configuration, which can also be the diameter of the junction of the outer wall 106 and the transition wall 108, can be in the range of 25mm to 60mm, 30mm to 50mm, 30mm to 45mm, or 35 to 40mm. Return to reference Figure 1E The diameter 166 of the outer wall 106 at the junction between the first and second regions 128, 130, which may also be the inflection point of the concave / convex shape of the outer wall 106, may be in the range of 25mm to 60mm, 30mm to 55mm, 35mm to 50mm, 40mm to 50mm, 45 to 50mm, 40mm to 45mm, or 42 to 47mm. The axial length 168 of the outer wall 106 may be in the range of 25mm to 30mm, 27mm to 32mm, 24mm to 35mm, or 26mm to 34mm. The axial length 174 of the transition wall 108 may be in the range of 2mm to 3mm, 2.0mm to 2.5mm, 1mm to 5mm, 2mm to 4mm, or 2mm to 8mm. However, in other variations, the cross-section of the outer wall 106 may include a generally straight wall configuration, i.e., cylindrical or frustoconical.

[0025] See also Figure 1GIn the embodiment of the present invention, the axial dimension of the first region 128 of the outer wall 106 and the axial dimension of the second region 130 of the outer wall 106 can vary depending on the desired relative implantation level of the valve 100 relative to the annulus. The axial dimension of the first region 128 of the outer wall 106 measured parallel to the longitudinal axis of the valve 100 can be in the range of 6 mm to 20 mm, 8 mm to 18 mm, 10 mm to 15 mm, or 12 mm to 15 mm. The axial dimension of the second region 130 of the outer wall 106 measured parallel to the longitudinal axis of the valve 100 can be in the range of 16 mm to 20 mm, 15 mm to 20 mm, 12 mm to 24 mm, or 10 mm to 28 mm. The ratio of the axial length of the second portion, or a portion of the outer wall without any of the plurality of longitudinal struts, to the axial length of the first portion, or a portion of the outer wall with at least some of the plurality of longitudinal struts, can be in the range of 1:1 to 1:1.5, 1:1.2 to 1:1.4, or 1:1.3 to 1:1.4. The ratio of the axial dimension of the inner wall 104 and the transition wall 108 combined to the axial dimension of the outer wall 106 and the transition wall 106 combined can be in the range of about 1:1 to 1:1.5, 1:05 to 1:1.4, 1:1.1 to 1:1.2, or 1:1.15 to 1.20, or 1:1.2 to 1:1.3. For example, the relative difference in the axial dimension of the outer wall 106 and the inner wall can be in the range of -5mm to +15mm, -2mm to +12mm, 0mm to +8mm, +1mm to +5mm, or +2mm to +4mm. For example, the wall length ratio of the inner wall 104 to the outer wall 106 (excluding the transition wall 108) can be in the range of 1:0.8 to 1:2, 1:1 to 1:1.8, 1:1 to 1:15, 1:1.1 to 1:1.4, 1:1.1 to 1:1.3, 1:1.2 to 1:1.4. The ratio between the diameter 166 of the outer wall 106 at the junction of the first and second portions of the outer wall 106 and the maximum diameter 160 of the outer wall 106 can be in the range of 1:1 to 1:1.5, 1:1.2 to 1:1.4, 1:1.3 to 1:1.4, or 1:1.2 to 1:1.3.

[0026] See also Figure 1H The inlet or inflow angle formed by the opening 126 of the outer wall 106 and the inlet 118 of the inner wall 104 or the longitudinal axis 120 of the stent 100 can be in the range of 15 to 20 degrees, 16 to 20 degrees, 14 to 22 degrees, 16 to 19 degrees, 5 to 35 degrees, 10 to 25 degrees, 12 to 25 degrees, 20 to 30 degrees, 25 to 35 degrees, or 25 to 30 degrees. Figure 1EIn the illustrated embodiment, where the cross-sectional configuration of the outer wall 106 is non-linear, the inflow angle of the outer wall 106 can be defined by a second region 130 of the outer wall 106, such as from a longitudinal midpoint or inflection point of the outer wall 106 to a lip or opening of the outer wall 106. In some variations, it may be beneficial for the second region 130 of the outer wall 106 to include a concave configuration relative to the inner wall 104, such that the immediate area of ​​the outer wall 106 surrounding the opening 126 is oriented relatively closer to the longitudinal axis 120 rather than transversely relative to the longitudinal axis 120. Referring to FIG. 1I , the axial length difference 172 between the opening 126 of the outer wall 106 and the inlet 118 of the inner wall 104 can be between 4 mm and 6 mm, 4 mm and 5 mm, 4 mm and 8 mm, or 3 mm and 6 mm. Return to FIG. Figure 1F At the junction of the first and second portions 128, 130 of the outer wall 106 (or at the terminal end of the longitudinal struts 154), the ratio between the diameter 152 of the inner wall 104 and the diameter 166 of the outer wall 106 can be in the range of 1:1 to 1:2, 1:1.4 to 1:1.6, 1:1.5 to 1:1.6, 1:1.3 to 1:1.7 or 1:1.2 to 1:1.8. For example, the ratio between the diameter 152 of the inner wall 104 and the maximum diameter 160 of the outer wall can be in the range of 1:1.5 to 1:3, 1:1.7 to 1.2.7, 1:1.8 to 1:2.5, 1:1.9 to 1:2.2 or 1.9 to 1:2.1.

[0027] As previously described, in some embodiments, the outer wall 106 of the support structure 100 includes a non-cylindrical shape when in the expanded configuration. This may include a flared or frustoconical shape. The outer wall 106 may include a first region 128 adjacent to the transition wall 108 and a second region 130 forming an outer opening 126. Relative to the outside of the support structure 100 adjacent to the outer wall 106 (e.g., a position not within the lumen 102 or the annular cavity 110), the first region 128 may present a concave curvature and the second region 130 may present a convex curvature. The first region 128 may include a region of reduced diameter of the support structure 100, thereby allowing at least a portion of the first region 128 to expand against the natural valve leaflet and / or anatomical orifice. The region of reduced diameter of the support structure 100 may be located at a portion of the outer wall 106, or extend from a portion of the outer wall 106 located at or near the outer joint 124, which may prevent or at least inhibit the support structure 100 from interfering with the anatomical structure downstream of the outer joint 124. The second region 130 can include an area of ​​increased diameter of the support structure 100, thereby allowing at least a portion of the second region 130 to provide a mechanical interference or resistance to displacement. The area of ​​increased diameter of the support structure 100 can be located at a portion of the outer wall 106, or extend from a portion of the outer wall 106 located at or near the outer opening 126. In one example, the second region 130 can be used to anchor the support structure 100 in the atrium above the tricuspid valve and form a seal in the atrium to prevent or at least inhibit blood from flowing back from the ventricle to the atrium. In one example, the boundary between the first region 128 and the second region 130 can be a nominal or expected location of a valve annulus, such as the tricuspid valve annulus.

[0028] In one embodiment, Figure 1E , the first region 128 may present a first average radius of curvature R1 and the second region 130 may present a second average radius of curvature R2. The average radii of curvature R1 and R2 may be independently selected to be 20 mm to 30 mm, 25 mm to 35 mm, 30 mm to 40 mm, 35 mm to 45 mm, 40 mm to 50 mm, 45 mm to 55 mm, 50 mm to 60 mm, 55 mm to 65 mm, or 60 mm to 70 mm. In one embodiment, at least one of the first region 128 or the second region 130 may be substantially linear.

[0029] The average radius of curvature of the stent structure 100 can be used to define the geometry of the stent in the expanded configuration, but can also affect the geometry of the stent in the delivery or collapsed configuration (eg, Fig. 7A). A region or segment of the stent may be configured to have a smaller average radius of curvature to facilitate folding the stent in that region or segment when the stent is folded to achieve a collapsed configuration. A region or segment of the stent may be configured to have a larger average radius of curvature to facilitate straightening the region or segment to achieve a collapsed configuration. For example, for stent structure 100, a relatively small radius of curvature R T The larger radii of curvature R1 and R2 facilitate folding or collapsing of the stent structure about the transition wall 108, while the larger radii of curvature R1 and R2 facilitate flattening of the first region 128 and the second region 130, respectively, during delivery or loading of the device into a delivery system.

[0030] The non-cylindrical configuration of the outer wall 106 may allow the outer wall 106 to exhibit more shortening than the inner wall 104 when transitioning from a relatively straight orientation in the collapsed configuration to a concave / convex orientation in the expanded configuration. In some variations, the longitudinal deflection when expanded of a portion of the first region 128 at or adjacent to (e.g., within 10 mm, within 5 mm, or within 3 mm) the region of reduced diameter of the outer wall 106 may be less than 5 mm, 4 mm, 3 mm, 2 mm, or 1 mm. In some variations, the longitudinal deflection when expanded of a portion of the second region 130 at or adjacent to (e.g., within 10 mm, within 5 mm, or within 3 mm) the region of increased diameter of the outer wall 106 may be less than 5 mm, 10 mm, 15 mm, or 20 mm.

[0031] It should be noted that the general funnel-shaped shape (e.g., non-hourglass-shaped) of the outer wall 106 formed by the first and second regions 128, 130 can facilitate attachment of the stent to an anatomical structure that is not in a plane, such as the tricuspid valve. For example, an outer wall presenting an hourglass shape can be used to anchor the stent to an anatomical structure that is in a plane, such as the mitral valve. However, anchoring an hourglass-shaped stent to a non-planar anatomical structure may cause the stent to tilt, which in turn may cause the stent to interfere with adjacent anatomical structures. At the same time, the funnel-shaped shape of the outer wall 106 is believed not to present such a problem.

[0032] The stent structure disclosed herein also includes a plurality of integrally formed stent strut segments, such as Figures 1A to 1D Some struts may be characterized as longitudinal strut segments 132 or lateral strut segments 134. The longitudinal strut segments 132 are generally located in the radial plane 135 (in Figure 1E 135 ), wherein the longitudinal axis 120 is also located therein, wherein the two longitudinal strut segments 132 are located in different adjacent radially oriented planes. The lateral strut segments 134 are formed integrally with the longitudinal strut segments 132. The lateral strut segments 134 are generally located in a tangential plane relative to the radial plane 135 (e.g., the lateral strut segments 132 generally extend within the curved surface of a cylinder or funnel). Figure 1EAs shown, in embodiments having an even number of equally spaced longitudinal struts, each radial plane 135 will include the longitudinal axis 120 of the stent structure 100 and two longitudinal strut segments 132 located on opposite sides of the stent structure 100 .

[0033] Continuous longitudinal strut segments 132 form longitudinal struts 154. Each longitudinal strut extends along at least a portion of at least one wall (e.g., at least one of the inner wall 104, the outer wall 106, or the transition wall 108). In one embodiment, each longitudinal strut extends along the entire inner wall 104 (e.g., from the first opening 116 to the inner joint 122), the entire transition wall 108 (e.g., from the inner joint 122 to the outer joint 124), and along a portion or the entire outer wall 106. In such an embodiment, the longitudinal struts provide structural integrity and better redistribute forces to the inner wall 104, the transition wall 108, and the portion of the outer wall 106 that constitutes the longitudinal struts. In some variations, the first region 128 of the outer wall 106 may also include a portion of the longitudinal struts 154 and the terminal end 156 in the outer wall 106, while the second region 130 of the outer wall 106 may lack any of the longitudinal struts. At the same time, a portion of the outer wall 106 that does not include the longitudinal struts may exhibit greater flexibility than a portion of the outer wall 106 that includes the longitudinal struts. A portion of the outer wall including and excluding longitudinal struts can also be characterized as including a longitudinal non-shortened portion connected to the transition wall and a shortened portion located at the free end of the outer wall. When the support structure 100 switches from a contracted configuration to an expanded configuration, the greater flexibility of a portion of the outer wall 106 that does not include longitudinal struts can facilitate greater expansion of this portion of the outer wall 106. In some embodiments, the length of the longitudinal strut segment in the outer wall can be shorter, the same, or longer than the length of the longitudinal strut segment in the inner wall. In other variations, the length of the longitudinal strut segment in the outer wall can be characterized as a percentage of the total longitudinal length of the outer wall, such as 25% to 100%, 30% to 75%, 40% to 60%, etc.

[0034] In one particular example, the first region 128 of the outer wall 106 includes a longitudinal strut, while the second region 130 of the outer wall 106 does not include a longitudinal strut. When the stent structure 100 is set in a valve, the location of the outer wall 106 where the longitudinal strut terminates can be the expected location of the valve ring (e.g., the tricuspid ring). In such an example, when the stent is expanded at the implantation site, the diameter of the second region 130 can increase more than the diameter of the first region 128. The greater flexibility of a portion of the outer wall 106 that does not include a longitudinal strut can make a portion of the outer wall 106 that does not include a longitudinal strut better conform to adjacent anatomical structures than a portion of the outer wall 106 that includes a longitudinal strut. In one embodiment, at least one longitudinal strut can be provided along the entire folded length of the stent structure 100 (e.g., along the length of the inner wall 104, through the transition wall 108, and along the length of the outer wall 106). In addition, the shortening of the first region 128 and the second region 130 depends at least in part on the presence of the longitudinal strut 132. For example, when switching from an expanded configuration to a collapsed configuration, the longitudinal strut causes the first region 128 to exhibit little or no shortening. When the stent structure 100 switches from the expanded configuration to the collapsed configuration, the limited shortening of the first region 128 prevents or at least minimizes the increase in length of the stent structure 100 (measured parallel to the longitudinal axis 120), which in turn makes the stent structure 100 easier to insert into the anatomical structure without interfering with the anatomical structure. When the stent structure 100 switches from the expanded configuration to the collapsed configuration, the lack of longitudinal strut segments 132 in the second region 130 causes the second region 30 to exhibit shortening. Notably, the shortening of the second region 130 is less likely to adversely interfere with the anatomical structure (e.g., the tricuspid valve) than the first region 128 because the second region 30 can be used to interact with the anatomical structure to anchor the stent structure 100.

[0035] In the exemplary stent structure 100, the longitudinal strut segments 132 along the lumen 102 of the stent structure 100 include a linear configuration, so the longitudinal strut segments 132 are generally parallel in their expanded and collapsed configurations. Due to this arrangement, the lumen 102 may not exhibit or may exhibit limited shortening when changing from the collapsed configuration to the expanded configuration. This can reduce or eliminate any axial stretching of the valve structure attached to the lumen 102. This can also allow the lumen 102 to be predictably positioned and deployed while reducing the risk of inadvertent positional displacement.

[0036] The support structure 100 can include any suitable number of longitudinal struts. In one example, the number of longitudinal struts is a multiple of the number of leaflets forming the valve. In such an example, the number of longitudinal struts allows each leaflet to be equally supported, thereby preventing or at least inhibiting uneven wear between the leaflets that may cause the valve structure to fail. For example, when the valve is a tricuspid valve, the valve including the support structure 100 can include three leaflets. In this case, the number of longitudinal struts is a multiple of 3 (e.g., the support structure 100 includes 3, 6, 9, 12, 15, 18, or 21 longitudinal struts).

[0037] At least some of the longitudinal strut segments 132 of the inner wall 104 may define one or more perforations 144 extending therethrough. The perforations 144 are configured to facilitate insertion of a leaflet (e.g., Figure 6 The leaflets 668 of the valve structure 664 shown are attached (e.g., sewn, patched, sutured, riveted, clamped, stapled) to the longitudinal struts. In one example, the longitudinal strut segment 132 defining the perforation 144 can be positioned closer to the first opening 116 of the lumen 102 than the second opening 118, because it has generally been found that it is more advantageous to position the leaflets closer to the first opening 116 than to the second opening 118. In one example, when the valve includes two leaflets, perforations are formed in every two longitudinal struts, when the valve includes three leaflets, perforations are formed in every three longitudinal struts, and so on, to prevent or at least inhibit uneven wear between the leaflets. In one example, each longitudinal strut segment 132 defining the perforation 144 includes a plurality of perforations 144. In one example, a portion of the longitudinal strut segment 132 defining the perforation 144 can present a greater width than the remainder of the longitudinal strut segment 132, thereby allowing the longitudinal strut segment 132 to accommodate a larger perforation 144.

[0038] The lateral struts may form a partial or complete circumference or perimeter around the wall of the support structure 100. To facilitate expansion and contraction of the entire support structure 100, one or more lateral strut segments 134 or all lateral strut segments 134 may include a pair of inclined legs. Each lateral end of each inclined leg is continuous or integrally formed with the longitudinal strut segment 132, and each inclined leg is joined together in the center to form a bending region. Although the curved configuration formed by the two inclined legs can include a simple bend, in other examples, each leg can extend in the center to form a hairpin bending region.

[0039] The support structure 100 can include any suitable number of lateral struts. In one embodiment, the number of lateral struts can depend on the flexibility required for the wall including the lateral struts and the length of the wall. For example, the first region 128 can include fewer lateral struts than the inner wall 104 of the adjacent portion because the first region 128 can expand more than the inner wall 104 when expanding from a collapsed configuration. In one embodiment, the number of lateral struts can depend on the support configuration of the lateral struts. For example, the support configuration of the lateral struts of the second region 130 allows greater flexibility than the support configuration of the lateral struts of the first region 128. Therefore, the second region 130 can include more lateral struts (e.g., three) than the first region 128 (e.g., one).

[0040] The lateral strut segments can form different stent configurations (e.g., different stent structures). Figure 2A , a portion of a support configuration 200a according to an embodiment is shown, which shows an exemplary configuration of a lateral support segment. In the illustrated embodiment, the support configuration 200a includes a first longitudinal support segment 232a and a second longitudinal support segment 232a'. The support configuration 200a also includes a first lateral support segment 234a and a second lateral support segment 234a'. The first lateral support segment 234a includes a first leg 236a extending from the first longitudinal support segment 232a and a second leg 238a extending from the second longitudinal support segment 232a'. The first and second legs 236a, 238a are joined together at the center of the bending area 240a. The second lateral support segment 234a' includes a first leg 236a' extending from the first longitudinal support segment 232a and a second leg 238a' extending from the second longitudinal support segment 232a'. The first and second legs 236a', 238a' are joined together at the center of the bending area 240a'. The longitudinal strut segments 232a, 232a' and the lateral strut segments 234a, 234a' together form a closed perimeter of the unit 242a.

[0041] In some variations, the legs 236a, 238a, 236a', 238a' may comprise a generally linear or straight configuration, with deformation occurring primarily at the intersections between the legs 236b, 238a, 236a', 238a' and the longitudinal strut segments 232a, 232a' and at the curved regions 240a, 240a'. In some variations, the legs 236a, 238a, 236a', 238a' may comprise a generally linear or straight configuration. In some variations, the legs 236a, 238a, 236a', 238a' may comprise a generally curved configuration.

[0042] The first and second lateral strut segments 234a, 234a' can include an acute leg angle θ measured between a linear or substantially linear portion of the legs 236a, 238a, 236a', 238a' and an adjacent longitudinal strut segment. For example, the acute leg angle θ can be measured between a linear or substantially linear portion of the first leg 236a of the first lateral strut segment 234a and the first longitudinal strut segment 232a. The acute leg angle θ can vary depending on whether the strut configuration 200a forms a portion of an inner wall or a portion of an outer wall, for example, because the outer wall exhibits more foreshortening than the inner wall. Typically, when the support configuration 200a forms a portion of an inner wall, the acute leg angle θ is less than when the support configuration 200a forms a portion of an outer wall. For example, when the support configuration 200a forms a portion of an inner wall, the acute leg angle θ can be 50° or less, 45° or less, 40° or less, 35° or less, 30° or less, 25° or less, 20° or less, 15° or less, or in the range of 10° to 20°, 15° to 25°, 20° to 30°, 25° to 35°, 30° to 40°, 35° to 45°, or 40° to 50°. When the support configuration 200a forms a portion of an outer wall, the acute leg angle θ can be 30° or greater, 35° or greater, 40° or greater, 45° or greater, 50° or greater, 55° or greater, 60° or greater, 65° or greater, 70° or greater, or in the range of 30° to 40°, 35° to 45°, 40° to 50°, 45° to 55°, 50° to 60°, 55° to 65° or 60° to 70°.

[0043] The first and second lateral strut segments 234a can be separated from each other by a maximum distance d, which is measured parallel to the longitudinal axis of the lumen ( Figure 2A ). The maximum distance d may be selected to be 3 mm to 5 mm, 4 mm to 6 mm, 5 mm to 7 mm, 6 mm to 8 mm, 7 mm to 9 mm, 8 mm to 10 mm, 9 mm to 11 mm, or 10 mm to 12 mm. In one embodiment, the maximum distance d may vary depending on whether the strut configuration 200a forms part of an inner wall or an outer wall, as the maximum distance d may affect the flexibility of the wall. Typically, when the strut configuration 200a forms part of an inner wall, the maximum distance d may be smaller than when the strut configuration 200a forms part of an outer wall, as the inner wall may exhibit less foreshortening than the outer wall.

[0044] exist Figure 2AIn the exemplary strut configuration 200a shown, the longitudinal strut segments 232a, 232a' can be parallel or non-parallel, depending on whether the wall comprising the longitudinal strut segments 232a, 232a' is cylindrical or non-cylindrical (e.g., frustoconical). In variations, when the longitudinal strut segments 232a, 232a' are non-parallel, the longitudinal struts 232a, 232a' can have a small radial angle orientation of 1° to 5°, 2° to 10°, or 5° to 30° to the longitudinal axis.

[0045] In some variations, when greater stiffness is desired, the lateral strut segments 234a, 234a' are generally non-uniform along their lengths. This can be accomplished by increasing the relative width of the lateral strut segments 234a, 234a' near the intersection between the legs 236a, 238a, 236a', 238a' and the adjacent longitudinal strut segments, and decreasing the relative width of the lateral strut segments 234a and 234a' at or near the bend regions 240a, 240a'.

[0046] In some variations, the curved regions 240a, 240a' may include a simple angle or curved configuration. In other variations, the curved regions 240a, 240a' may include an arcuate structure having a greater curvature on the same side of the lateral strut segment acute angle and a lesser curvature found on the side of the lateral strut segment obtuse angle.

[0047] In some embodiments, the orientation of the lateral strut segments 234a, 234a' may vary. Figure 2AAs shown in , the lateral strut segments 234a, 234a' can be oriented so that the lateral strut segments 234a, 234a' are roughly parallel. In such an example, the curved regions 240a, 240a' can be oriented in the same direction (e.g., pointing), and the unit 242a can present a herringbone shape. The curved regions 240a, 240a' can be oriented in an upstream or downstream direction. Orienting the lateral strut segments 134a, 234a' to be parallel can prevent the lateral strut segments 234a, 234a' from contacting each other when the support configuration 200a is in a collapsed configuration, because such contact can limit the extent to which the support configuration 200a can be collapsed. In one example, the lateral strut segments 234a, 234a' can be oriented so that the lateral strut segments 234a, 234a' are not parallel. In such an example, the curved regions 240a, 240a' can be oriented in different directions (e.g., pointing), and the unit 242a can present an hourglass or diamond shape. In one example, the lateral strut segments 234a, 234a' are oriented such that the bend regions 240a, 240a' point away from the terminal ends on the respective walls that are closest to the lateral strut segments 234a, 234a'. For example, when the stent configuration 200a forms a portion of an inner wall, the bend regions 240a, 240a' can be oriented to point away from the first opening or the second opening of the inner cavity (e.g., the first or second openings 116, 118), or when the stent configuration 200a forms a portion of an outer wall, the bend regions can be oriented away from the external joint or the outer opening. Orienting the bend regions 240a, 240a' to point away from the terminal ends of their respective walls can prevent the bend regions 240a, 240a' from protruding from the rest of the stent structure when in the collapsed configuration. It should be noted that in some embodiments, such as Figure 1D As shown, the lateral strut segments may be sufficiently offset from the terminal ends of the walls so that the lateral strut segments are less likely to protrude from the remainder of the stent.

[0048] Figure 2B Another exemplary embodiment of a support configuration 200b is depicted. Unless otherwise disclosed herein, support configuration 200b is the same or substantially similar to support configuration 200a. For example, support configuration 200b includes a first lateral support segment 234b and a second lateral support segment 234b'. The first lateral support segment 234b includes a first leg 236b and a second leg 238b, which are joined together at the center of the bending area 240b. The second lateral support segment 234b' includes a first leg 236b' and a second leg 238b', which are joined together at the center of the bending area 240b'. The lateral support segments 234a, 234b' together form a closed perimeter of a support opening or unit 242b. Support configuration 200b may not include a longitudinal support segment (as shown), or may include a longitudinal support segment.

[0049] The legs 236b, 238b', 236b', 238b' of the lateral strut segments 234b, 234b' in the expanded configuration may include a bent or curvilinear configuration. For example, each leg 236, 238 may have a generally S-shaped shape. The generally S-shaped shape of the legs 236b, 238b', 236b', 238b' may allow for a greater amount of expansion of the strut configuration 200b from the delivery configuration to the expanded configuration, and / or may distribute more stress and strain along the entire length of the strut configuration 200b.

[0050] Other examples of strut configurations are disclosed in U.S. Patent No. 11,197,755, issued on December 14, 2021, the entire contents of which are incorporated herein by reference.

[0051] Return to See Figures 1A to 1E , showing whether the lateral strut segment 134 presents Figure 2A The pillar configuration 200a in Figure 2B The support structure 200b in FIG. 100b, or any other support configuration, may depend on the position of the lateral support segment 134 on the support structure 100. For example, the lateral support segment 134 of the inner wall 104 may generally present Figure 2A The strut configuration 200a is preferably a linear configuration because the inner wall 104 exhibits a relatively low radial expansion. In other words, the lateral strut segments 134 of the inner wall 104 can exhibit a generally linear configuration, with deformation occurring primarily at the intersections between the lateral strut segments 132 and the adjacent longitudinal strut segments 132 and at their curved regions. The curved regions of the lateral strut segments 134 can point toward the nearest terminal away from the inner wall 104. Thus, the lateral strut segments 134 can form units that exhibit a herringbone, hourglass, or other suitable shape. The lateral strut segments 134 of the first region 128 can also generally exhibit a linear configuration. Figure 2A The strut configuration 200a in FIG. 1 is because the first region 128 exhibits a relatively low amount of radial expansion compared to the second region 130. The lateral strut segments 134 of the second region 130 may generally exhibit Figure 2B The strut configuration 200b in the embodiment allows the lateral strut segments 134 to remain interconnected even if the second region 130 does not include longitudinal struts. The lateral strut segments 134 of the second region 130 also allow the second region 130 to exhibit greater flexibility than the first region 128 of the inner wall 104 and the outer wall 106.

[0052] The greater flexibility of the second region 130 facilitates switching from the collapsed configuration of the stent structure 100 to its expanded configuration.

[0053] The greater flexibility of the second region 130 also facilitates the second region 130 to conform to its surrounding anatomical structure.

[0054] In one embodiment, the leg length of the lateral strut segments 134 of the inner wall 104 is generally shorter than the leg length of the lateral strut segments 134 of the outer wall 106 because the inner wall 104 exhibits a relatively lower amount of radial expansion compared to the outer wall 106 .

[0055] The spacing between adjacent longitudinal or lateral struts can be equal throughout the stent structure 100, or can vary along the folded stent structure. For longitudinal struts, the number of struts can vary depending on the flexibility or radial expansion force required for the stent structure 100, or based on the width of the strut segment required to achieve the desired radial expansion force or flexibility. For lateral struts, relatively larger spacing can be provided in areas where greater radial expansion and / or reduced expansion force is desired, and smaller spacing can be provided in areas where reduced radial expansion and / or greater expansion force is desired.

[0056] The support structure 100 may include one or more barbs 146 that deviate radially outward relative to adjacent struts. The barbs 146 are configured to penetrate or otherwise press into adjacent anatomical structures. Penetrating or otherwise pressing into the anatomical structure with the barbs 146 can help fix the support structure 100 to the anatomical structure. For example, as previously described, the area of ​​increased diameter of the outer wall 106 provides a mechanical interference or resistance to displacement. However, the area of ​​increased diameter of the outer wall 106 may only provide mechanical interference or resistance to displacement of the support structure 100 in the upstream direction. Therefore, when the pressure upstream of the support structure 100 increases (e.g., when the atrium receives blood from the superior vena cava), the area of ​​increased diameter of the outer wall 106 can prevent the displacement of the support structure 100. However, when the downstream pressure increases (e.g., when the ventricle delivers blood through the pulmonary valve pump), the area of ​​increased diameter of the outer wall 106 may not prevent or inhibit its displacement. Pressing the barbs 146 into the anatomy may provide mechanical interference or resistance to displacement of the stent structure 100 caused by increased pressure downstream of the stent structure 100 .

[0057] The barbs 146 may be located anywhere along and / or around the outer wall 106 of the stent structure 100. In one embodiment, at least some of the barbs 146 may be located in the second region 130 of the outer wall 106 because, at least due to the relative flexibility of the second region 130, the second region 130 is likely to contact the anatomical structure. In such an embodiment, the barbs 146 may extend outwardly from portions of the lateral strut segments 134 that intersect each other because such portions of the lateral strut segments 134 may exhibit greater stiffness and strength than other portions of the lateral strut segments 134. Alternatively or additionally, the barbs 146 may extend from portions of the lateral strut segments 134 that do not intersect with other lateral strut segments 134, such as at the curved regions of the lateral strut segments 134. It should be noted that shortening the second region 130 increases the number of barbs 146 that may be formed thereon. In one embodiment, at least some of the barbs 146 extend outwardly from the first region 128. The barb 146 may include a length 158 within the range of, for example, 1 mm to 10 mm, 2 mm to 8 mm, 3 mm to 6 mm, or 3 mm to 5 mm.

[0058] In one embodiment, barb 146 can be more toward outer opening 126 than external engagement portion 124. When the pressure of stent structure 100 downstream increases, this orientation of barb 146 can facilitate pressing barb 146 into anatomical structure. In one embodiment, barb 146 can extend 2-10mm, 3-9mm or 4-6mm outward from outer wall 106. In one embodiment, the number of barbs 146 formed in stent structure 100 can be 1-10, 5-15, 10-20, 15-25, 20-30, 25-35, 30-40, 35-45, 40-50, 45-55 or 50-60. It should be noted that, generally, increasing the number of barbs 146 allows barbs 146 to anchor stent structure 100 more firmly to anatomical structure. Barbs can include generally linear or arcuate shapes.

[0059] When in the expanded configuration, the support structure 100 may include one or more of the following features:

[0060] 1) The net longitudinal strut length (i.e., the maximum distance spanned by the stent along the longitudinal axis 120) is within the range of 15-55 mm, 20-50 mm, or 30-40 mm;

[0061] 2) the maximum stent diameter or transverse dimension is within the range of 40-80 mm, 50-70 mm, or 55-65 mm;

[0062] 3) a maximum stent diameter or transverse dimension measured at the outer junction 124 in the range of 15-60 mm, 20-50 mm, or 25-40 mm, and optionally 10-40 mm, 15-35 mm, or 20-30 mm smaller than the maximum stent diameter or transverse dimension;

[0063] 4) The inner cavity length is in the range of 10-50 mm, 15-40 mm or 20-30 mm;

[0064] 5) The inner lumen diameter or maximum cross-sectional dimension is within the range of 10-40 mm, 15-35 mm, or 26-31 mm;

[0065] 6) the radial width of the transition wall measured between the inner joint 122 and the outer joint 124 is in the range of 2-10 mm, 3-9 mm, 4-8 mm, or 5-7 mm;

[0066] 7) the longitudinal length of the outer wall measured from the outer joint 124 to the outer opening 126 parallel to the longitudinal axis 120 is in the range of 10-40 mm, 20-35 mm or 25-30 mm;

[0067] 8) the ratio of the longitudinal length of the outer wall to the maximum stent diameter (i.e., the longitudinal length of the outer wall / the maximum stent diameter) is in the range of 0.35 to 1.0, 0.45 to 0.80, or 0.50 to 0.60;

[0068] 9) the number of longitudinal struts is divisible by 3, for example, one or more of 3, 6, 9, 12, 15, 18 or 21 longitudinal struts;

[0069] 10) the ratio of the radial distance between the tip of the barb and the longitudinal axis of the stent structure to the radial distance between the adjacent longitudinal strut or outer wall segment (excluding the barb) 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

[0070] 11) The offset between the second inner opening 118 and the outer opening 126 is positive (i.e., protruding from the outer opening), neutral (i.e., flush with the outer opening), negative (i.e., recessed from the outer opening) and / or in the range of -4 to -12 mm, -5 to -10 mm, -6 to -9 mm, +1 to +8 mm, +2 to +6 mm, +3 to +5 mm, -3 to +3 mm, +0 to +3 mm, -12 to +5 mm, -6 to +6 mm or -7 mm to +4 mm.

[0071] The support structure 100 need not be limited to requiring selection of each of the above-mentioned features, and a single feature or a subset of features may also be considered.

[0072] exist Figures 1A to 1EIn the illustrated embodiment, the support structure 100 includes a plurality of longitudinal struts and a plurality of lateral struts, each of which includes a set of continuous longitudinal or lateral strut segments, respectively. In a particular example of the support structure 100, nine equally spaced longitudinal struts are provided, as well as seven complete sets of lateral struts along the folded support structure 100. Three sets of closely spaced lateral struts are provided along the inner wall 104, which have relatively straight or minimally curved legs and whose curved regions are oriented away from the nearest terminal end of the inner wall 104. The transition wall 108 does not include lateral struts having a relatively uniform radius of curvature. The outer wall 106 includes four sets of lateral struts.

[0073] The replacement valve can also include one or more skirt materials for one or more regions of the stent structure. The skirt material can include solid, tightly woven or loosely woven materials of autologous, homologous or heterologous or artificial materials, which can be the same or different from the leaflet material of the valve. The skirt material can include polytetrafluoroethylene (PTFE), polyester or polyethylene terephthalate (PET) materials. In the variation including the open-pored material, the average pore size can be within the size range of about 0.035mm to 0.16mm, or 0.05mm to 0.10mm, or 0.07mm to 0.09mm. The open-pored material can provide greater elasticity or flexibility in the region that undergoes a large configuration change in the stent structure. Other regions of the stent can provide a solid sheet without holes, and elasticity or flexibility is not required in these regions. The skirt material can include a single layer or multilayer structure, and include one or more coatings to regulate thrombosis, tissue ingrowth, and / or lubricity.

[0074] As previously described, the stent structure disclosed herein may include one or more barbs. In one embodiment, the skirt material initially does not define one or more holes corresponding to one or more barbs of the stent structure. In such an embodiment, the barbs may pierce the skirt material, forming a tear in the skirt material, and the barbs may extend through the tear. The tear in the skirt material formed by the barbs may include sharp or other jagged features that form pressure concentration points and weaken the skirt material. In one embodiment, the skirt material initially defines one or more holes corresponding to one or more barbs of the stent structure. These holes allow the barbs to extend through the skirt material without tearing the skirt material. Unlike tearing, the hole may be substantially free of sharp or jagged features that may form pressure concentration points, thereby significantly reducing the possibility of failure of the skirt material during use. In one embodiment, the skirt material initially does not define one or more holes corresponding to one or more barbs of the stent structure. In such an embodiment, as previously described, the barbs may form a tear in the skirt material. After the tear is formed, the portion of the skirt material defining the tear may be heated (e.g., melted) to reduce the number of pressure concentration points formed by the tear.

[0075] Figure 3 350 is a cross-sectional schematic diagram of a replacement valve 350 including a stent structure 300 and a skirt material 352 according to an embodiment. Unless otherwise disclosed herein, the replacement valve 350 is the same or substantially similar to any replacement valve disclosed herein. The skirt material 352 includes two different materials attached to the stent structure 300, namely a braided material 354 and a knitted material 356. The braided material 354 includes a solid or tightly woven material. The braided material 354 is disposed on the second end 330 of at least a portion of the inner wall 304 (e.g., all or most of the inner wall 306) and at least a portion of the outer wall 306 that define the inner cavity 302. The braided material 354 can also extend through the outer opening 326. The braided material 354 can be substantially impermeable to blood, or at least more impermeable to blood than the knitted material 356. In other words, the braided material 354 forms a barrier to blood flow. The braided material 354 extending through the outer opening 326 can guide blood from an upstream position through the first opening 316 of the inner cavity 302 and into the inner cavity 302. For example, the braided material 354 extending through the outer opening 326 can be angled relative to the longitudinal axis 320 to form a funnel that directs blood into the lumen 302. The braided material 354 disposed in the lumen 302 prevents or at least inhibits blood from flowing out of the lumen 302 except through the second opening 318 of the lumen 302. The braided material 354 disposed across the outer opening 326 and disposed on the second region 330 of the outer wall 306 substantially prevents blood from flowing back from a location downstream of the replacement valve 350 to a location upstream of the replacement valve 350 because the second region 330 is generally adjacent to the anatomical structure of the individual. Therefore, the braided material 354 can direct blood to flow through the replacement valve 350 and can prevent blood from flowing back through the replacement valve 350.

[0076] The knitted material 356 can be disposed on the remaining portion of the support structure 300 that is not covered by the braided material 354. For example, the knitted material 356 can be disposed on at least a portion of the first region 328 of the transition wall 308 and the outer wall 306. Optionally, the knitted material 356 can also be disposed near the portion of the inner wall 304 and the second region 330 that is not covered by the braided material 354, such as a portion of the inner wall 304 downstream of the valve structure (not shown). The blood permeability of the knitted material 356 is greater than that of the braided material 354. The increased blood permeability of the knitted material 356 provides cell migration and tissue ingrowth into the replacement valve 350. The increased blood permeability of the knitted material 356 can also allow blood to flow into the annular cavity 310, thereby inhibiting or at least reducing the pressure difference between the annular cavity 310 and the downstream position of the replacement valve 350, which may cause the support structure 300 to collapse. It should be noted that the knitted material 356 can present a sufficiently small porosity to resist the passage of a thrombus that may form in the annular cavity 310.

[0077] Knitted material 356 can exhibit greater flexibility than woven material 354. Thus, the inclusion of knitted material 356 in skirt material 354 facilitates expansion of support structure 300 from its collapsed configuration more than when skirt material 352 includes only woven material 354. However, woven material 354 is disposed on portions of support structure 300 (e.g., second region 330) that expand the most when support structure 300 expands from its collapsed configuration. In one embodiment, the portion of woven material 354 disposed on second region 330 can define one or more slits 358 (e.g., Figure 3 Schematically shown using small gaps). The slits 358 can extend at least partially through the cells formed in the support structure 300. The slits 358 extending through different cells can be continuous (i.e., a single slit 358 extends through multiple cells) or discontinuous (i.e., each slit 358 extends only through a single cell). The slits 358 allow the support structure 300 to contract and expand freely. For example, when the support structure 300 is in a contracted configuration, the cells of the support structure 300 can elongate vertically. The slits 358 prevent the relatively rigid braided material 354 from limiting such elongation of the cells because the slits 358 allow the braided material 354 to separate. The slits 358 can be configured to overlap or otherwise be substantially closed when the support structure 300 is expanded, thereby inhibiting blood flow through the slits 358.

[0078] Figure 4 4 is a cross-sectional schematic diagram of a replacement valve 450 including a support structure 400 and a skirt material 452 according to an embodiment. Unless otherwise disclosed herein, the replacement valve 450 is the same or substantially similar to any replacement valve disclosed herein. For example, the skirt material 452 can include a braided material 454 and a knitted material 456.

[0079] The braided material 454 may be disposed on the second region 430 defining at least a portion of the inner wall 404 and at least a portion of the outer wall 406 of the lumen 402. The braided material 454 does not extend through the outer opening 426. Instead, the braided material 454 extends between a portion of the inner wall 404 and a portion of the second region 430 at an intermediate position spaced apart from the second opening 418 and the outer opening 426. The braided material 454 extending through the intermediate position allows blood to flow from a position upstream of the replacement valve 450 into a portion of the annular cavity 410, thereby minimizing the pressure difference between the upstream position and the annular cavity 410, which may otherwise cause the braided material 454 to tear. It should be noted that the braided material 454 extending through the intermediate position may abut a portion of the second region 430, the opposite side of which has the braided material 454 disposed thereon, to prevent blood from flowing back. In one embodiment, the portion of the braided material 454 extending through the intermediate position may be angled relative to the longitudinal axis 420 to form a funnel that guides blood into the lumen 402. In such an embodiment, the portion of braided material 454 disposed within lumen 402 adjacent to the portion of braided material 454 extending through the intermediate location may define one or more apertures 460 to allow blood to flow from annular lumen 410 into lumen 402. Knitted material 456 may be disposed on portions of stent structure 400 not covered by braided material 454.

[0080] Figure 5 550 is an isometric view of a replacement valve 550 according to an embodiment. Unless otherwise disclosed herein, the replacement valve 550 is the same or substantially similar to any replacement valve 550 disclosed herein. For example, the replacement valve 550 can include a stent structure (not shown, obscured) and a skirt material 552.

[0081] The skirt material 552 can define one or more lead openings 562 configured to allow electrical leads (e.g., wires) to extend through the replacement valve 550. For example, depending on the location of the replacement valve 550, the replacement valve 550 can be positioned in a channel through which electrical leads from a pacemaker or other electrical leads extend in the heart. The lead openings 562 formed in the skirt material 552 can allow these electrical leads to pass through the replacement valve 550, thereby preventing the replacement valve 550 from interfering with the passage of such electrical leads.

[0082] The wire opening 562 may include any suitable opening. In one embodiment, the wire opening 562 may include a hinged door, a trap door, a permeable and / or pierceable membrane, or a duckbill port, as these structures may prevent or at least inhibit blood from flowing back through the wire opening 562. In one embodiment, the wire opening 562 may be formed in a portion of the skirt material 552, extend through the outer opening (as shown), be disposed on the inner wall of the support structure, be disposed on the transition wall of the support structure, be disposed on the outer wall of the support structure (e.g., the first or second region), or extend through at least one of an intermediate location spaced apart from the outer opening.

[0083] As previously mentioned, the replacement valves disclosed herein may include a valve structure. Figure 6 664 is an isometric view of a replacement valve 650 according to an embodiment including a valve structure 664. Unless otherwise disclosed herein, the replacement valve 650 is the same or substantially similar to any replacement valve disclosed herein. For example, the replacement valve 650 includes a stent structure (not shown, obscured) and a skirt material 652.

[0084] The replacement valve 650 can be configured so that blood flow can be received through the second opening 618, through the inner cavity 602, and out of the first opening (not shown, obscured). Therefore, the replacement valve 650 may include a valve structure 664 attached to the inner cavity 602. The valve structure 664 can be any of a variety of valve structures, including a flap valve, a cage ball valve, or a leaflet valve. In the case of a leaflet valve, the valve structure 664 includes a plurality of leaflets 668. The leaflets 668 may include autologous, homologous or heterologous or artificial materials, such as natural materials or anatomical structures, such as porcine, bovine or equine pericardial tissue or valves, or biological materials from the patient's own cells, and may be fixed with any of a variety of chemicals, such as glutaraldehyde, to reduce the antigenicity of the valve and / or change the physiological and / or mechanical properties of the valve material. The leaflet valve may be a bileaflet or trileaflet valve structure. As previously described, the leaflet valve 668 can be attached to the longitudinal and / or lateral struts of the lumen 602 using perforations or sutures.

[0085] manufacture

[0086] In some variations, the stent structure can be manufactured using a superelastic nitinol tube that is laser cut into various slits and slots to achieve the initial tubular stent shape. Next, in a series of cyclic deformation, heating and cooling steps, the tubular stent is gradually expanded to at least the initial size of the stent structure lumen. The portion of the stent structure corresponding to the transition wall and the outer wall is then further gradually expanded to the desired diameter and then gradually everted using a mandrel to form the outer wall to achieve the shape of the outer wall. In another step, one or more curved regions on the lateral struts surrounding the intermediate region are radially displaced outward to form barbs.

[0087] In another embodiment, after the initial cutting of the tube, the tube can undergo a series of cyclic deformation, heating and cooling steps to gradually expand the tube to the initial size of the outer cavity of the stent structure, and then invert the portion of the stent structure corresponding to the transition wall and the inner wall into the outer wall to form the closed end and inner wall. The outer wall can be further expanded or gradually 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 middle region. One or more curved regions on the lateral struts surrounding the middle region can also be radially displaced outward to form retaining hooks or structures.

[0088] Valve loading and delivery

[0089] In one embodiment, one or more sutures (e.g., tension members) can be attached to a replacement valve (e.g., a stent structure of a replacement valve) to control expansion and contraction of different regions on the stent structure until ultimately deployed at the treatment site. In other embodiments, sutures or wraps can be provided external to one or more regions of the stent structure.

[0090] In some examples, the sutures can be tensioned or tightened to shrink the outer and inner walls of the stent structure for loading onto the delivery catheter. The sutures can be manipulated to fold the inner wall first, then the outer wall, or both can be folded simultaneously. Similarly, one end of the inner or outer wall can be shrunk first, or both ends of the inner or outer wall can be shrunk simultaneously. This can be done at room temperature or in a sterile cold or ice water bath when in use or during manufacture. After shrinkage, the sheath can be extended distally over the distal catheter portion where the replacement valve is located. The valve can also be rinsed in sterile saline before loading to remove any preservatives remaining on the valve.

[0091] In some variations, the transition wall of the stent structure is folded downward at the inner joint so that in the collapsed configuration, the transition wall is directly above the delivery catheter or tool, just like the inner wall, but in other examples, the outer wall is pulled distally during the folding and loading process and the transition wall is deployed at the outer joint, such that when collapsed to the collapsed configuration, the transition wall is located radially outside the inner wall.

[0092] The fixed sutures of the delivery system can be controlled by the user at the proximal end by a pull ring, a sliding rod and / or a knob, and these fixed sutures are also configured to be locked in place unless during movement by a bias spring or a mechanical interlocking configuration known in the art. The proximal end of the delivery system can also be robotically controlled using any of the various robotic catheter guidance systems known in the art. In addition to any flush cavity, guidewire cavity or steering wire cavity provided (including rapid exchange guidewire configurations), the sutures can also slide along one or more internal lumens of the delivery catheter. The sutures can exit at different locations in the distal region of the delivery catheter and can exit through multiple openings in the distal region of the catheter. Multiple openings can be spaced apart and / or spaced apart longitudinally around the circumference of the catheter body, depending on the area of ​​the stent structure controlled by the sutures.

[0093] In one exemplary method of delivering a replacement valve, the patient is placed on an operating table and draped and sterilized in the usual manner. Anesthesia or sedation is achieved. The femoral vein is accessed percutaneously or open, and a guide wire is inserted. The guide wire is manipulated to reach the right atrium. Alternatively, image guidance may be used to detect if there is a patent foramen ovale or residual pathway, and the guide wire may be passed through a pre-existing anatomical opening. An electrocautery catheter may also be used to create an opening in the atrial septum. Once in the right atrium, the guide wire is passed through the tricuspid valve.

[0094] See also Fig. 7A , the delivery system 770 with the delivery catheter 772 and the valve 750 is located opposite the tricuspid valve opening 776. For clarity, Fig. 7A Only the stent structure of the valve 750 is shown. The delivery system 770 can also be further manipulated to adjust the angle of entry through the tricuspid valve opening 776 to be approximately perpendicular to the native valve opening and / or centered on the tricuspid valve opening 776. Once the desired catheter position is achieved, the delivery catheter 772 is withdrawn proximally to expose the contracted valve 750.

[0095] In one embodiment, the group of sutures (not shown) is removed, thereby allowing the folded valve 750 to expand. All groups of sutures can be removed simultaneously, or they can be removed or partially released in a predetermined order. In some variations, when the valve 750 is not positioned correctly, the sutures can be re-tensioned to re-contract the valve 750 to facilitate the repositioning and / or reorientation of the valve 750. After the valve 750 is correctly positioned and expanded, the sutures can be cut or otherwise released or separated from the valve, and the sutures can be withdrawn into the catheter and optionally withdrawn from the proximal end of the catheter. The delivery catheter and guidewire can then be removed from the patient's body and bleeding can be stopped at the femoral vein site.

[0096] Allowing the valve 750 to expand can include allowing the transition wall 708 and the outer wall 706 of the valve 750 to expand at least partially outward. The expansion of the transition wall 708 and the outer wall 706 helps to further center and orient the valve 750, for example, before full release. The expansion of the outer wall 706 can also expose the barbs extending from the outer wall 706 to contact the anatomical structure of the tricuspid valve 776. Allowing the valve 750 to expand can also include allowing the inner wall 704 to expand, which also allows the outer wall 706 to achieve its unconstrained expansion against the tricuspid valve opening 776. Figure 7B The valve 750 is shown fully expanded and properly positioned in the tricuspid valve opening 776 .

[0097] Although the embodiments herein have been specifically shown and described with reference to their embodiments, those skilled in the art will appreciate that various changes in form and detail 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 in order.

Claims

1. A replacement heart valve, characterized in that: include: Integrated bracket structure, including: contracted configuration and expanded configuration; an outer wall including a region of increased diameter and a region of reduced diameter; an inner wall defining the inner cavity; A transition wall between the outer wall and the inner wall; and a valve structure located in the lumen of the inner wall; The integrated support structure further comprises a plurality of longitudinal struts and a plurality of lateral struts formed integrally together, each longitudinal strut being continuously positioned along the inner wall, the transition wall and a portion of the outer wall; wherein a ratio of an axial length of a portion of the outer wall without any of the plurality of longitudinal struts to an axial length of a portion of the outer wall having at least some of the plurality of longitudinal struts is in a range of 1:1 to 1:1.

5.

2. The replacement heart valve according to claim 1, characterized in that: The replacement heart valve is a tricuspid replacement valve.

3. The replacement heart valve according to claim 1, characterized in that: The transition wall is located downstream of the region of increased diameter.

4. The replacement heart valve according to claim 1, characterized in that: The outer wall includes a first region extending from the transition wall and a second region extending from the open end of the outer wall, the first region including the plurality of longitudinal struts and the second region lacking the plurality of longitudinal struts.

5. The replacement heart valve according to claim 4, characterized in that: The first region includes at least one of the multiple lateral struts, and the second region includes at least one of the multiple lateral struts; at least one of the multiple lateral struts in the first region presents a strut configuration different from the strut configuration of at least one of the multiple lateral struts in the second region.

6. The replacement heart valve according to claim 5, characterized in that: At least one of the plurality of lateral struts in the first region includes legs in a generally linear relationship with each leg deformed near an end thereof, and wherein at least one of the plurality of lateral struts in the second region includes legs in a generally S-shaped relationship.

7. The replacement heart valve according to claim 4, characterized in that: At least a portion of the first region of the outer wall is configured to be disposed in a ventricle of a heart, and at least a portion of the second region of the outer wall is configured to be disposed in an atrium of the heart.

8. The replacement heart valve according to claim 4, characterized in that: The second region of the outer wall is configured to be more flexible than the first region of the outer wall.

9. The replacement heart valve according to claim 1, characterized in that: The outer wall includes a plurality of barbs extending therefrom.

10. The replacement heart valve according to claim 9, characterized in that: The outer wall includes a first region extending from the transition wall and a second region extending from the open end of the outer wall, the first region including the plurality of longitudinal struts and the second region being free of the plurality of longitudinal struts; and The plurality of barbs extend from a second region of the outer wall.

11. The replacement heart valve according to claim 9, characterized in that: The plurality of barbs are oriented toward the outer opening of the outer wall rather than toward the transition wall.

12. The replacement heart valve according to claim 1, wherein: The plurality of longitudinal struts and the plurality of lateral struts comprise Nitinol.

13. The replacement heart valve according to claim 1, wherein: Also included is a skirt material disposed on at least a portion of the outer wall, at least a portion of the inner wall, and at least a portion of the transition wall.

14. The replacement heart valve according to claim 13, characterized in that The skirt material includes a first material and a second material different from the first material.

15. The replacement heart valve according to claim 14, characterized in that The first material comprises a woven material and the second material comprises a knitted material.

16. The replacement heart valve according to claim 15, characterized in that The woven material is disposed on at least a portion of the inner wall and at least a portion of the outer wall extending from an outer opening of the outer wall, a portion of the woven material extends between the outer wall and the inner wall, and wherein the knitted material is disposed on at least a portion of the transition wall and a portion of the outer wall extending from the transition wall.

17. The replacement heart valve according to claim 16, characterized in that A portion of the braided material extending between the inner wall and the outer wall extends through the outer opening.

18. The replacement heart valve according to claim 16, characterized in that: A portion of the braided material extending between the inner wall and the outer wall extends through an intermediate location spaced from the outer opening.

19. The replacement heart valve of claim 13, wherein: The outer wall includes a plurality of barbs extending therefrom; and The skirt material includes a plurality of openings formed therein, each of the plurality of openings being configured to receive one of the plurality of barbs.

20. The replacement heart valve of claim 13, wherein: The skirt material defines one or more wire openings therein configured to allow one or more electrical wires to pass therethrough.

21. A replacement heart valve according to any one of the preceding claims, characterized in that: A ratio of an axial length of a portion of the outer wall without any of the plurality of longitudinal struts to an axial length of a portion of the outer wall with at least some of the plurality of longitudinal struts is in a range of 1:1 to 1:1.

4.

22. A replacement heart valve according to any one of the preceding claims, characterized in that An inflow angle between the inlet of the outer wall and the inlet of the inner wall is in a range of 5 degrees to 35 degrees.

23. The replacement heart valve according to claim 22, characterized in that The inflow angle is in the range of 25 degrees to 35 degrees.

24. A replacement heart valve according to any one of the preceding claims, characterized in that: A ratio between a diameter of the inner wall and a diameter of the outer wall at an end point of at least one of the plurality of longitudinal struts is in a range of 1:1 to 1:

2.

25. The replacement heart valve of claim 24, wherein: A ratio between a diameter of the inner wall and a diameter of the outer wall at an end point of at least one of the plurality of longitudinal struts is in a range of 1.4 to 1.

6.

26. A replacement heart valve according to any one of the preceding claims, characterized in that: The transition wall has an average radius of curvature in the range of about 1 mm to 5 mm.

27. The replacement heart valve of claim 26, wherein: The transition wall has an average radius of curvature in the range of about 1.5 mm to 3 mm.

28. A replacement heart valve according to any one of the preceding claims, characterized in that A ratio of an axial dimension of the inner wall and transition wall combination to an axial dimension of the outer wall and transition wall combination is in the range of about 1:1 to 1:1.

5.

29. The replacement heart valve of claim 28, wherein: A ratio of an axial dimension of the inner wall and transition wall combination to an axial dimension of the outer wall and transition wall combination is in a range of about 1.1 to 1.

3.

30. A replacement heart valve according to any one of the preceding claims, characterized in that A ratio of an axial dimension of the inner wall to an axial dimension of the outer wall is in a range of about 1:05 to 1:1.

4.

31. The replacement heart valve of claim 30, wherein: A ratio of an axial dimension of the inner wall to an axial dimension of the outer wall is in a range of about 1.1 to 1.

3.

32. A replacement heart valve according to any one of the preceding claims, characterized in that: A ratio between a diameter of the outer wall including at least one end of the plurality of longitudinal struts and a maximum diameter of the outer wall is in a range of 1:1 to 1:1.

5.

33. The replacement heart valve of claim 32, wherein: A ratio between a diameter of the outer wall including at least one end of the plurality of longitudinal struts and a maximum diameter of the outer wall is in a range of 1:1.2 to 1:1.4.

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