Systems, devices, and methods having stent frame features

Abstract

A replacement heart valve includes one or more stent framework features, including embedded barbs, ring attachment structures, or attachment plates.

Description

[0001] Related applications This application claims priority to U.S. Application No. 63 / 621,496, filed January 16, 2024, pursuant to 35 USC §119(e), which is incorporated herein by reference in its entirety for any purpose. Technical Field

[0002] This patent application generally relates to the treatment of valvular diseases, and more specifically to methods and devices for minimally invasive mitral valve replacement. Background Technology

[0003] Valvular heart disease poses a significant burden on patients and the healthcare system, with a global prevalence of 2-3%, and its prevalence is rising in older populations. Valvular disease can be caused by a variety of factors, including autoimmune, infectious, and degenerative causes. The epidemiology of valvular disease also varies depending on the valves involved; rheumatic heart disease is the leading cause of primary mitral regurgitation and mitral stenosis worldwide, while in developed countries, secondary mitral disease caused by left ventricular dysfunction is more common.

[0004] Although surgical repair and valve replacement remain the primary treatments for mitral valve disease in current clinical guidelines from the American Heart Association and the American College of Cardiology, transcatheter mitral valve repair is recommended for certain patient groups. In the 2017 key update and the 2014 Guidelines for the Management of Patients with Valvular Disease, the AHA / ACC recommended percutaneous mitral commissurotomy for severe mitral stenosis and transcatheter mitral valve repair for certain patients with severe symptoms, severe primary mitral regurgitation, reasonable life expectancy, and comorbidities predisposing them to surgery. Summary of the Invention

[0005] Compared to the more mature transcatheter aortic valve therapy, the anatomical and physiological complexity of the mitral valve poses a challenge to its further development. For example, some mitral valve replacement therapies under development compromise between the sealing and anchoring properties of the external portion of the replacement valve and the support of the valve leaflets. Other therapies attempt to address this challenge with two-piece replacement valve structures, but these may have higher delivery failure rates or be too large for transcatheter delivery.

[0006] To address these issues, the embodiments described herein relate to a replacement heart valve comprising a one-piece, folded, double-walled stent with a stent sheath and leaflet valves connected to the stent lumen. The double-walled stent structure decouples or reduces the influence of the retaining structure's geometry on the valve support geometry. This includes the effects of external forces acting through the valve annulus during the cardiac cycle, as well as the influence of non-circular annulus shapes. The double-walled stent structure also allows the valve support to have a different size and shape than the outer annulus support without conforming to natural anatomy. This reduces the risk of outflow tract obstruction and / or damage due to ventricular contraction by allowing the outer wall to have a shorter longitudinal length than the inner wall supporting the leaflet. The one-piece design also achieves greater structural integrity by reducing the complexity associated with the joints, welds, or mechanical connections between and / or their in-situ connections to the support components.

[0007] In some variations, this allows the expandable valve to shrink to a size smaller than 29F, such as less than 10 mm, or between 24F and 29F, or between 8 mm and 10 mm. The heart valve can be delivered using a multi-pulley, suture-based stent restraint assembly on a catheter or delivery tool. A fixed guide opening or structure at the distal end of the delivery system allows for independent expansion of the distal and proximal ends of the stent outer wall via sutures passing through the opening. Control of inner wall expansion can be performed simultaneously with or independently of outer wall expansion. This dual-wall integrated design reduces the complexity of valves with multi-component structures while decoupling the valve support geometry from the retaining structure, and still provides collapsibility suitable for transcatheter delivery.

[0008] In at least one example of this disclosure, a replacement heart valve is provided, comprising an integral stent frame. The integral stent frame includes a plurality of longitudinal struts and a plurality of circumferential struts forming a tubular inner wall having a central lumen and an outer wall surrounding the tubular inner wall. The replacement heart valve also includes a replacement leaflet valve located in the central lumen of the tubular inner wall and connected to the tubular inner wall. The replacement valve further includes a bracket connected to a junction between two adjacent leaflets of the replacement leaflet valve and connected to one of the longitudinal struts of the tubular inner wall. The integral stent frame of the replacement heart valve includes a collapsed configuration and an expanded configuration.

[0009] In one example, the bracket may be U-shaped, having a first arm and a second arm that slide across the two adjacent leaflets and the suture. A portion of each leaflet is disposed on the inner and outer surfaces of the first and second arms of the bracket. In one example, each arm of the bracket further includes multiple holes, and the longitudinal strut includes multiple holes, thereby enabling the bracket to be sutured to the adjacent leaflets and to the longitudinal strut of the tubular inner wall. In one example, each leaflet includes one layer located within the bracket and one layer located outside the bracket. In one example, each leaflet includes two layers located within the bracket and one layer located outside the bracket. In one example, each leaflet includes one layer located within the bracket and two layers located outside the bracket. In one example, the number of brackets for the replaced heart valve corresponds to the number of leaflets in the replaced leaflet valve. In one example, the replaced heart valve further includes a skirt disposed on the outer wall of the integrated stent frame. The skirt includes multiple incisions disposed on the lower edge of the skirt. In one example, the multiple incisions include an arcuate shape. In one example, each of the plurality of incisions is located between extensions of the skirt, and each extension is aligned with a longitudinal strut of the outer wall of the integrated stent frame. In one embodiment, the replacement heart valve further includes a plurality of ring structures coupled to the integrated stent frame. Each of the plurality of ring structures includes a ring and an extension extending from the ring. The extension includes a plurality of holes for securing the ring structure to the integrated stent frame. In one example, the plurality of ring structures are coupled to the atrial side of the integrated stent frame. In one example, the plurality of longitudinal struts transition from straight longitudinal struts in the tubular inner wall to curved longitudinal struts in the outer wall via a transition wall between the outer wall and the tubular inner wall. In one example, the transition wall tapers at a predetermined angle relative to the longitudinal axis of the integrated stent frame. In one example, the plurality of longitudinal struts of the outer wall include a compound curve that transitions from a concave curve to a convex curve, then back to a concave curve, then back to a convex curve, and then back to a concave curve. In one example, a first end region of the outer wall includes a circumferential strut projecting radially outward from the outer wall.

[0010] In at least one example of this disclosure, a replacement heart valve is provided, comprising an integral stent frame having a collapsed configuration and an expanded configuration. The integral stent frame includes an inner wall defining a central lumen, an outer wall radially spaced from the inner wall, and a plurality of longitudinal struts. The plurality of longitudinal struts transition from straight longitudinal struts in the inner wall to curved longitudinal struts in the outer wall via a transition wall between the outer wall and the inner wall. The integral stent frame also includes a plurality of inner circumferential struts forming the inner wall and a plurality of outer circumferential struts forming the outer wall. The integral stent frame also includes a plurality of lateral protrusions projecting radially outward from the outer wall and extending circumferentially around the outer wall of the integral stent frame. Each lateral protrusion includes a pair of angled legs joined at the apex of the lateral protrusion. Each lateral protrusion includes a compound curve with an inflection point that transitions each lateral protrusion from a concave curve at the longitudinal strut of the outer wall to a convex curve. The replacement heart valve also includes a replacement leaflet valve located in the central lumen of the inner wall.

[0011] In one example, the multiple longitudinal supports of the outer wall include a composite curve that transitions from a concave curve to a convex curve, then back to a concave curve, then back to a convex curve, and then back to a concave curve.

[0012] In one example of this disclosure, a method of laying sutures to collapse and replace a valve includes obtaining a replacement valve. The replacement valve includes an integral support frame having a plurality of longitudinal struts and a plurality of circumferential struts forming a tubular inner wall having a central lumen and an outer wall surrounding the tubular inner wall. The replacement valve also includes a replacement leaflet valve located in the central lumen of the tubular inner wall and connected to the tubular inner wall. The replacement valve further includes twelve rings connected to the integral support frame, the twelve rings being equally spaced around the circumference of the integral support frame and positioned at twelve hour positions on an analog clock. The method includes: attaching a first segment of the suture to a sixth ring; passing the first segment of the suture clockwise through a seventh, eighth, and ninth ring, skipping a tenth ring; passing the first segment of the suture clockwise through an eleventh, twelfth, and first ring; and attaching the first segment of the suture to a second ring. The method further includes: passing the second segment of the suture clockwise through the third, fourth, and fifth loops, skipping the sixth loop, passing the second segment of the suture clockwise through the seventh, eighth, and ninth loops, and tying the second segment of the suture to the tenth loop. The method further includes: passing the third segment of the suture clockwise through the eleventh, twelfth, and first loops, skipping the second loop, passing the third segment of the suture clockwise through the third, fourth, and fifth loops, and tying the third segment of the suture to the sixth loop.

[0013] In one example of this disclosure, a method of laying sutures to collapse and replace a valve includes obtaining a replacement valve. The replacement valve includes an integral support frame comprising a plurality of longitudinal struts and a plurality of circumferential struts forming a tubular inner wall having a central lumen and an outer wall surrounding the tubular inner wall. The replacement valve also includes a replacement leaflet located in the central lumen of the tubular inner wall and connected to the tubular inner wall. The replacement valve further includes twelve rings connected to the integral support frame, the twelve rings being equally spaced around the circumference of the integral support frame and positioned at twelve hour positions on an analog clock. The method includes: attaching a first segment of the suture to a fifth ring; passing the first segment of the suture clockwise through a sixth, seventh, eighth, and ninth ring, skipping a tenth ring; passing the first segment of the suture counterclockwise through an eleventh and tenth ring; and attaching the first segment of the suture to a ninth ring. The method further includes: passing the second segment of the suture clockwise through the tenth, eleventh, twelfth, and first loops, skipping the second loop; passing the second segment of the suture counterclockwise through the third and second loops; and tying the second segment of the suture to the first loop. The method further includes: passing the third segment of the suture clockwise through the second, third, fourth, and fifth loops, skipping the sixth loop; passing the third segment of the suture counterclockwise through the seventh and sixth loops; and tying the third segment of the suture to the fifth loop.

[0014] In one example, a replacement heart valve is provided, comprising: an integral stent frame including a plurality of longitudinal struts and a plurality of circumferential struts forming a tubular inner wall having a central lumen and an outer wall surrounding the tubular inner wall; a replacement leaflet valve located in the central lumen of the tubular inner wall and connected to the tubular inner wall; and a bracket connected to a junction between two adjacent leaflets of the replacement leaflet valve and to one of the longitudinal struts of the tubular inner wall, wherein the integral stent frame includes a collapsed configuration and an expanded configuration. The bracket may be U-shaped, having a first arm and a second arm that slide across the two adjacent leaflets and the junction, wherein a portion of each leaflet is disposed on the inner and outer surfaces of the first and second arms of the bracket. Each arm of the bracket may also include a plurality of holes, and the longitudinal struts include a plurality of holes, thereby enabling the bracket to be sutured to the adjacent leaflets and to the longitudinal struts of the tubular inner wall. Each leaflet may include one layer located within the support and one layer located outside the support, two layers located within the support and one layer located outside the support, and / or one layer located within the support and two layers located outside the support. The number of supports may correspond to the number of leaflets in the replacement valve. The replacement heart valve may also include a skirt disposed on the outer wall of the integrated stent frame, wherein the skirt includes a plurality of incisions disposed on the lower edge of the skirt. The plurality of incisions may include an arcuate or bow-shaped shape. Each of the plurality of incisions may be disposed between extensions of the skirt, and wherein each extension is aligned with a longitudinal strut of the outer wall of the integrated stent frame. The replacement heart valve may also include a plurality of ring structures coupled to the integrated stent frame, wherein each of the plurality of ring structures includes a ring and an extension extending from the ring, wherein the extension includes a plurality of holes for binding the ring structure to the integrated stent frame. The plurality of ring structures may be coupled to the atrial side of the integrated stent frame. The plurality of longitudinal supports may transition from straight longitudinal supports in the tubular inner wall to curved longitudinal supports in the outer wall via a transition wall between the outer wall and the tubular inner wall. The transition wall may taper at a predetermined angle relative to the longitudinal axis of the integral support frame. The plurality of longitudinal supports on the outer wall may include compound curves that transition from a concave curve to a convex curve, then back to a concave curve, then back to a convex curve, and then back to a concave curve. A first end region of the outer wall may include circumferential supports projecting radially outward from the outer wall.

[0015] In another example, a replacement heart valve may be provided, comprising: an integral stent frame having a collapsed configuration and an expanded configuration, the integral stent frame including an inner wall defining a central lumen, an outer wall radially spaced from the inner wall, a plurality of longitudinal struts, wherein the plurality of longitudinal struts transition from straight longitudinal struts in the inner wall to curved longitudinal struts in the outer wall via a transition wall between the outer wall and the inner wall, a plurality of inner circumferential struts forming the inner wall and a plurality of outer circumferential struts forming the outer wall, and a plurality of lateral protrusions projecting radially outward from the outer wall and extending circumferentially around the outer wall of the integral stent frame, wherein each lateral protrusion includes a pair of angled legs connected at the apex of the lateral protrusion, wherein the lateral protrusion includes a compound curve having an inflection point that transitions each lateral protrusion from a concave curve at each lateral protrusion connecting to a longitudinal strut of the outer wall to a convex curve; and a replacement leaflet valve located in the central lumen of the inner wall. The multiple longitudinal supports of the outer wall may include a composite curve, which transitions from a concave curve to a convex curve, then back to a concave curve, then back to a convex curve, and then back to a concave curve.

[0016] In another exemplary embodiment, a method for laying sutures to collapse and replace a valve may be provided, comprising obtaining a replacement valve, the valve including an integral support frame including a plurality of longitudinal struts and a plurality of circumferential struts forming a tubular inner wall having a central lumen and an outer wall surrounding the tubular inner wall, a replacement leaflet valve located in the central lumen of the tubular inner wall and connected to the tubular inner wall, and a plurality of rings connected to the integral support frame, the plurality of rings being equally spaced around the circumference of the integral support frame; attaching a first segment of the suture to a first anchoring ring; passing the first segment of the suture through a first subset of rings, the first subset of rings including at least one continuous ring immediately adjacent to the first attachment ring; skipping adjacent rings already attached to the first anchoring ring. The process involves threading a first segment of the thread through a second anchoring ring of a first loop subset; threading a first segment of the thread through a second loop subset, the second loop subset comprising at least one threaded continuous loop immediately adjacent to the second anchoring ring; attaching the first segment of the thread to a third anchoring ring immediately adjacent to the threaded second loop subset; threading a second segment of the thread through a third loop subset, the threaded third loop subset comprising at least one continuous loop immediately adjacent to the third anchoring ring; skipping the first anchoring ring; threading the second segment of the thread through the threaded first loop subset and attaching the second segment of the thread to the second anchoring ring; and threading a third segment of the thread through the second loop subset, skipping the third anchoring ring, threading the third segment of the thread through the third loop subset, and attaching the third segment of the thread to the first anchoring ring. The first, second, and third loop subsets may each contain the same number of loops. The plurality of rings may include twelve rings, wherein the first anchoring ring is the sixth ring of the plurality of rings, the first subset of rings includes the seventh, eighth, and ninth rings of the plurality of rings, the second anchoring ring is the tenth ring of the plurality of rings, the second subset of rings includes the eleventh, twelfth, and first rings of the plurality of rings, and the third anchoring ring is the second ring of the plurality of rings, the third subset of rings includes the third, fourth, and fifth rings of the plurality of rings. The plurality of rings may include N rings and X subsets of rings, where N is divisible by X+1. Each of the X subsets of rings may include Y rings. In some further embodiments, each of the X subsets of rings may not overlap with any other X subsets of rings. In some specific embodiments, Y=3 and N=12.

[0017] In another embodiment, a method of arranging sutures to collapse a replacement valve is provided, which comprises obtaining a replacement valve, the replacement valve comprising an integrated stent frame, the integrated stent frame comprising a plurality of longitudinal struts and a plurality of circumferential struts, the plurality of longitudinal struts and the plurality of circumferential struts forming a tubular inner wall having a central lumen and an outer wall surrounding the tubular inner wall, replacement valve leaflets located in the central lumen of the tubular inner wall and connected to the tubular inner wall, and a plurality of rings connected to the integrated stent frame, the plurality of rings being arranged at equal intervals around the circumference of the integrated stent, tying a first section of a suture to a first anchoring ring, passing the first section of the suture in a first direction through a first X consecutive rings immediately adjacent to the first anchoring ring, skipping a second anchoring ring immediately adjacent to the first subset of consecutive rings, passing the first section of the suture in a second direction through a first Y consecutive rings that are fewer in number than the X consecutive rings, and tying the first section of the suture to the ring of the first X consecutive rings that is closest to the second anchoring ring, passing a second section of the suture in the first direction through the second anchoring ring and a second X consecutive rings immediately adjacent to the second anchoring ring, skipping a third anchoring ring immediately adjacent to the second X consecutive rings, passing the second section of the suture in the second direction through a second Y consecutive rings that are fewer in number than the X consecutive rings, and tying the second section of the suture to the ring of the second X consecutive rings that is closest to the third anchoring ring, passing a third section of the suture in the first direction through the third anchoring ring and a third X consecutive rings immediately adjacent to the third anchoring ring, skipping a fourth anchoring ring immediately adjacent to the third X consecutive rings, passing the third section of the suture in the second direction through a third Y consecutive rings, wherein Y < X, and tying the third section to the first anchoring ring. The plurality of rings may include N rings, and wherein N may be divisible by X. In some further embodiments, Y=0, or Y=2 and X=4.

[0018] In another example, a method of arranging sutures to collapse a replacement valve is provided, which includes obtaining a replacement valve. The valve includes an integral stent frame, the integral stent frame comprising a plurality of longitudinal struts and a plurality of circumferential struts, the plurality of longitudinal struts and the plurality of circumferential struts forming a tubular inner wall with a central lumen and an outer wall surrounding the tubular inner wall, replacement leaflet valves located in the central lumen of the tubular inner wall and coupled to the tubular inner wall, and a plurality of rings coupled to the integral stent frame, the plurality of rings being equally spaced around the circumference of the integral stent, wherein the relative positions of the rings are defined by a positive direction and a negative direction, then tying a first segment of the suture to a first anchoring ring, passing the first segment of the suture through a first X consecutive rings adjacent to the first anchoring ring in a first direction, where X>0, skipping Y rings immediately adjacent to the first X consecutive rings in the first direction, passing through Z consecutive rings in a second direction, where Z is 0 or greater than 1, and Z<X, and if Z=0, tying the first segment of the suture to the next consecutive ring in the first direction, or if Z>0, tying it to the next consecutive ring in the second direction, passing a second segment of the suture through a second X consecutive rings in the first direction, skipping Y rings immediately adjacent to the second X consecutive rings in the first direction, passing through Z consecutive rings in the second direction, where Z is 0 or greater than 1, and Z<X, and if Z=0, tying the second segment of the suture to the next consecutive ring starting from the second X consecutive rings in the first direction, or if Z>0, tying it to the next consecutive ring in the second direction, passing a third segment of the suture through a third X consecutive rings in the first direction, skipping Y rings immediately adjacent to the third X consecutive rings in the first direction, passing through Z consecutive rings in the second direction, where Z is 0 or greater than 1, and Z<X, and if Z=0, tying the third segment of the suture to the next consecutive ring starting from the third X consecutive rings in the first direction, or if Z>0, tying it to the next consecutive ring in the second direction. In some further variants, the suture pattern may be configured such that X=3 and Y=1 and Z=0, where X=4 and Y=1 and Z=2, where X≥2, or where X-Z=2.

[0019] In one embodiment, a support assembly is provided, comprising: an expandable support including a strut arrangement forming an outer wall, the outer wall including a first end region, a second end region, and an intermediate region therebetween; a plurality of tethering retaining structures circumferentially arranged around the first end region of the support and defining a circumferential tethering path; a plurality of tethering path locations evenly spaced along the circumferential tethering path, wherein each of the tethering retaining structures may be located at one of the tethering path locations, and wherein each tethering path location includes; a plurality of tethers (tether lines), wherein each of the plurality of tethers may include a main region located on the circumferential tethering path and a loop formed between two tethering retaining structures away from (away from) the circumferential tethering path, and wherein each of the plurality of tethers overlaps with at least one other tether along the circumferential tethering path. The main region of each of the plurality of tethers may include a first end region having a first end, a second end region having a second end, and an intermediate region located between the two and including its loop. Each first and second end of each tether may be fixedly attached to one of the plurality of tether path locations, or directly attached to the outer wall, or attached to a tether retaining structure. Each tether path location may include at least one tether retaining structure, and at least one tether path location may include two tether retaining structures, wherein a middle region of one of the tethers may be configured to slidably pass through the two tether retaining structures, and a loop of the one tether forms a loop between the two tether retaining structures away from the circumferential tether path. The at least one tether path location including two tether retaining structures may include tether path locations having two tether retaining structures, the number corresponding to the plurality of tethers. Each first end region and each second end region of each tether may slidably pass through at least one first tether retaining structure, the first tether retaining structure may be located at a tether path location different from the corresponding first end and second end tether path location. Each of the plurality of tether path locations fixedly attached to the first or second end of one of the tethers may be unfixedly attached to any other tether. Each tether retaining structure, fixedly attached to a first or second end of one of the tethers, may also be slidably passed through by different tethers. Each of the plurality of tethers may be configured to: slidably pass through one of the plurality of tether retaining structures without any other first tether slidably passing through or attached thereto; slidably pass through one of the plurality of tether retaining structures while another tether slidably passes through; and be fixedly attached to two tether retaining structures, both of which are also slidably passed through by another first tether. The number of tether path locations may be a multiple of three, and the plurality of first tethers may include three tethers. The number of tether path locations may include twelve tether path locations.The twelve tether path positions can be consecutive, including the first, second, third, fourth, fifth, sixth, seventh, eighth, ninth, tenth, eleventh, and twelfth path positions. Each of the fourth, eighth, and twelfth tether path positions may include two first tether holding structures, and each of the first, second, third, fifth, sixth, seventh, ninth, tenth, and eleventh tether path positions may include one first tether holding structure. Each of the plurality of tethers may overlap with at least two other tethers along the circumferential tether path. The plurality of tethering structures may be a plurality of first tethering structures, and the circumferential tethering path may be a first circumferential tethering path. The plurality of tethering path positions are a plurality of first tethering path positions. The support assembly may also include a plurality of second tethering structures, which are circumferentially arranged around the second end region of the expandable support and define a second circumferential tethering path. The plurality of second tethering path positions are evenly spaced along the second circumferential tethering path. Each of the second tethering structures may be located at one of the first tethering path positions, and each second tethering path position may include no second tethering structure, one second tethering structure, or two second tethering structures. A plurality of second tethers may include a main region located on the circumferential tethering path and a loop formed between two tethering structures away from the circumferential tethering path. Each of the plurality of second tethers may overlap with at least one other second tether along the second circumferential tethering path. The main region of each of the plurality of tethers may include a first end region having a first end, a second end region having a second end, and an intermediate region located between the two and including its loop. Each first end and each second end of each second tether may be fixedly attached to one of the plurality of second tether path locations, or directly attached to a support of the outer wall, or attached to a second tether retaining structure. The plurality of second tethers may include a non-overlapping arrangement. The plurality of second tethers may include an overlapping arrangement. The relative configuration of the plurality of first tether retaining structures and the plurality of first tethers along the first circumferential tether path may be the same as the relative configuration of the plurality of second tether retaining structures and the plurality of second tethers along the second circumferential tether path. The support may also include an inner wall and a transition wall between the inner wall and the transition wall, wherein the transition wall may be located in the first end region of the support. Each of the plurality of tether retaining structures may include an opening having a lateral or tangential orientation relative to the outer wall of the support. Each of the plurality of tether retaining structures may include a loop, a ring, or a clamp. Each of the plurality of tethered retaining structures may be fixedly attached to or continuously formed with respect to the outer wall of the support. Each of the plurality of tethered retaining structures may be movably or pivotally attached to the outer wall of the support via stitches or threads.The support assembly may further include a support cover, and each of the plurality of first tether retention structures may be attached to the support cover via the stitching or thread. Each of the plurality of tether path locations may be located at a longitudinal post of the post arrangement. At least one of the first end regions and the second end region of each of the plurality of tethers may overlap with itself along the circumferential tether path. At least one of the plurality of tether path locations may lack a tether retention structure. The at least one of the plurality of tether path locations lacking a tether retention structure may correspond in number to the plurality of tethers. Each of the plurality of first tether retention structures may project radially outward from the outer wall of the support.

[0020] In another variation, a replacement heart valve is provided, comprising: an integral stent frame including a plurality of longitudinal struts and a plurality of circumferential struts forming a tubular inner wall having a central lumen and an outer wall surrounding the tubular inner wall; a replacement leaflet valve located in the central lumen of the tubular inner wall and connected to the tubular inner wall; and a bracket connected to a junction between two adjacent leaflets of the replacement leaflet valve and connected to the tubular inner wall. The integral stent frame may include a collapsed configuration and an expanded configuration. The bracket may be U-shaped, having a first arm and a second arm that slide across the two adjacent leaflets and the junction, wherein a portion of each leaflet may be disposed on the inner and outer surfaces of the first and second arms of the bracket. Each arm of the bracket may also include a plurality of holes, and the longitudinal struts of the plurality of longitudinal struts may include a plurality of holes, wherein the bracket is sutured to the adjacent leaflets and sutured to the longitudinal struts. The bracket can be sewn to the adjacent leaflets with at least one suture, wherein each of the at least one suture passes through one of the plurality of holes in the longitudinal pillars of the plurality of longitudinal supports, through the everted layer of one of the adjacent leaflets, through a corresponding hole in the first arm of the bracket, through the bonding layer of the adjacent leaflet, through a corresponding hole in the second arm of the bracket, through the everted layer of another adjacent leaflet, and back through the first hole in the plurality of holes in the longitudinal pillars of the plurality of longitudinal supports to form a loop. Each suture may also pass through an adjacent hole in the plurality of holes in the longitudinal pillars of the plurality of longitudinal supports, through the everted layer of one of the adjacent leaflets, through an adjacent corresponding hole in the first arm of the bracket, through the bonding layer of the adjacent leaflet, through an adjacent corresponding hole in the second arm of the bracket, through the everted layer of another adjacent leaflet, and back through the adjacent hole in the plurality of holes in the longitudinal pillars of the plurality of longitudinal supports. Each leaflet may include a layer located inside the bracket and a layer disposed outside the bracket. The replacement heart valve of claim 33, wherein each leaflet may include two layers located within the bracket and one layer located outside the bracket. Each leaflet may include one layer located within the bracket and two layers located outside the bracket. The number of brackets may correspond to the number of leaflets in the replacement leaflet valve. The leaflet valve may be a three-leaflet valve, and the number of brackets may be three. The replacement heart valve may also include a skirt disposed on the outer wall of the integrated stent frame, wherein the skirt may include a plurality of incisions disposed on the lower edge of the skirt. The plurality of incisions may include an arcuate shape. Each of the plurality of incisions may be disposed between extensions of the skirt, and wherein each extension may be aligned with a longitudinal strut of the outer wall of the integrated stent frame. The stent frame may also include a plurality of tissue barbs formed within the longitudinal struts and surrounded by an elongated cavity.The skirt may further include pre-formed elongated grooves corresponding to the locations of the plurality of tissue barbs. The replacement heart valve may also include a plurality of ring structures coupled to the integrated stent frame, each of the plurality of ring structures including a ring and an extension extending from the ring, wherein the extension may include a plurality of holes for binding the ring structure to the integrated stent frame. The plurality of ring structures may be coupled to the atrial side of the integrated stent frame. The plurality of longitudinal struts may transition from straight longitudinal struts in the tubular inner wall to curved longitudinal struts in the outer wall via a transition wall between the outer wall and the tubular inner wall. The transition wall may taper at a predetermined angle relative to the longitudinal axis of the integrated stent frame. The plurality of longitudinal struts of the outer wall may include compound curves that transition from a concave curve to a convex curve, then back to a concave curve, then back to a convex curve, and then back to a concave curve. A first end region of the outer wall may include circumferential struts projecting radially outward from the outer wall.

[0021] In another embodiment, a replacement heart valve may be provided, comprising: an integral stent frame including a plurality of longitudinal struts and a plurality of circumferential struts forming a tubular inner wall having a central lumen and an outer wall surrounding the tubular inner wall, a replacement leaflet valve located in the central lumen of the tubular inner wall and connected to the tubular inner wall, and a skirt disposed on the outer wall of the integral stent frame, wherein the skirt may include a plurality of incisions disposed on a lower edge of the skirt, wherein the integral stent frame may include a collapsed configuration and an expanded configuration. The plurality of incisions may include arcuate shapes. Each of the plurality of incisions may be disposed between extensions of the skirt, and wherein each extension may be aligned with a longitudinal strut of the outer wall of the integral stent frame. Each extension of the skirt may include a rectangular shape. The stent frame may also include a plurality of tissue barbs formed within the longitudinal struts and surrounded by elongated cavities. The skirt may also include pre-formed elongated grooves corresponding to the locations of the plurality of tissue barbs.

[0022] In another embodiment, a replacement heart valve is provided, comprising: an integrated stent frame including a plurality of longitudinal struts and a plurality of circumferential struts forming a tubular inner wall having a central lumen and an outer wall surrounding the tubular inner wall, and a replacement leaflet valve located in the central lumen of the tubular inner wall and connected to the tubular inner wall, wherein the integrated stent frame may include a collapsed configuration and an expanded configuration. The replacement heart valve may further include a plurality of ring structures connected to the integrated stent frame, wherein each of the plurality of ring structures may include a ring and an extension extending from the ring, wherein the extension may include a plurality of holes for securing the ring structure to the integrated stent frame. The plurality of ring structures may be connected to the atrial side of the integrated stent frame. The plurality of longitudinal struts may transition from straight longitudinal struts in the tubular inner wall to curved longitudinal struts in the outer wall via a transition wall between the outer wall and the tubular inner wall. The transition wall may taper at a predetermined angle relative to the longitudinal axis of the integrated stent frame. The multiple longitudinal supports of the outer wall may include a composite curve that transitions from a concave curve to a convex curve, then back to a concave curve, then back to a convex curve, and then back to a concave curve. The first end region of the outer wall may include a circumferential support that projects radially outward from the outer wall.

[0023] In another variation, a replacement heart valve is provided, comprising: an integral stent frame having a collapsed configuration and an expanded configuration, the integral stent frame including an inner wall defining a central lumen, an outer wall radially spaced from the inner wall, a plurality of longitudinal struts, wherein the plurality of longitudinal struts transition from straight longitudinal struts in the inner wall to curved longitudinal struts in the outer wall via a transition wall between the outer wall and the inner wall, a plurality of inner circumferential struts forming the inner wall and a plurality of outer circumferential struts forming the outer wall, a plurality of lateral protrusions projecting radially outward from the outer wall and extending circumferentially around the outer wall of the integral stent frame, wherein each lateral protrusion may include a pair of angled legs joined at the apex of the lateral protrusion, wherein the lateral protrusion may include a composite curve having an inflection point that transitions each lateral protrusion from a concave curve at each lateral protrusion's connection to a longitudinal strut of the outer wall to a convex curve; and a replacement leaflet valve located in the central lumen of the inner wall. The multiple longitudinal supports of the outer wall may include a composite curve, which transitions from a concave curve to a convex curve, then back to a concave curve, then back to a convex curve, and then back to a concave curve.

[0024] In another embodiment, a stent valve may be provided, comprising: an integrated stent frame including a plurality of longitudinal struts and a plurality of circumferential struts, the plurality of longitudinal struts and the plurality of circumferential struts forming a tubular inner wall having a central lumen and an outer wall surrounding the tubular inner wall, a replacement leaflet valve located in the central lumen of the tubular inner wall and connected to the tubular inner wall, and a plurality of rings connected to the integrated stent frame, the plurality of rings being equally spaced around the circumference of the integrated stent frame, the plurality of rings including a first anchoring ring, a first ring subset including at least one continuous ring adjacent to the first anchoring ring, a second anchoring ring adjacent to the first ring subset, and a ring including at least one continuous ring adjacent to the second anchoring ring. The ring comprises: a second subset of at least one continuous ring; a subset of continuous rings; a third anchoring ring adjacent to the second subset of rings; a third subset of rings including at least one continuous ring adjacent to the third anchoring ring; a first seam segment attached to the first anchoring ring and passing through the first subset of rings and the second subset of rings, skipping the second anchoring ring, and attached to the third anchoring ring; a second seam segment attached to the third anchoring ring and passing through the third subset of rings and the first subset of rings, skipping the first anchoring ring, and attached to the second anchoring ring; and a third seam segment attached to the second anchoring ring and passing through the second subset of rings and the third subset of rings, skipping the third anchoring ring, and attached to the first anchoring ring. The first, second, and third seam segments may comprise a continuous seam. The first, second, and third seam segments may comprise separate (independent) seams. The first, second, and third subsets of rings may each comprise the same number of rings. The plurality of rings may include twelve rings, wherein the first anchoring ring may be the sixth ring of the plurality of rings, the first subset of rings may include the seventh, eighth, and ninth rings of the plurality of rings, the second anchoring ring may be the tenth ring of the plurality of rings, the second subset of rings may include the eleventh, twelfth, and first rings of the plurality of rings, the third anchoring ring may be the second ring of the plurality of rings, and the third subset of rings may include the third, fourth, and fifth rings of the plurality of rings. The plurality of rings may include N rings and X subsets of rings, where N is divisible by X+1. Each of the X subsets of rings may include Y rings. Each of the X subsets of rings may not overlap with any other X subsets of rings. The value may be Y=3 and N=12.

[0025] In another embodiment, a stent valve is provided, comprising: a one-piece stent framework, the one-piece stent framework comprising a plurality of longitudinal struts and a plurality of circumferential struts, the plurality of longitudinal struts and the plurality of circumferential struts forming a tubular inner wall having a central lumen and an outer wall surrounding the tubular inner wall, a replacement leaflet valve located in the central lumen of the tubular inner wall and coupled to the tubular inner wall, a plurality of rings coupled to the one-piece stent framework, the plurality of rings being equally spaced around the circumference of the one-piece stent, wherein the relative positions of the rings are defined by a positive direction and a negative direction, a first suture segment attached to a first anchoring ring of the plurality of rings and passing through a first X consecutive rings of the plurality of rings immediately adjacent to the first anchoring ring along a first direction, wherein X>0, skipping Y rings immediately adjacent to the first X consecutive rings along the first direction, and passing through Z consecutive rings of the plurality of rings along a second direction, wherein Z can be 0 or greater than 1, and Z<X, and if Z=0, attached to the next consecutive ring of the plurality of rings in the first direction, or if Z>0, attached to the next consecutive ring of the plurality of rings in the second direction, a second suture segment attached to the same ring as the first segment of the suture and not being the first anchoring ring and passing through a second X consecutive rings of the plurality of rings along the first direction, skipping Y rings of the plurality of rings immediately adjacent to the second X consecutive rings along the first direction, passing through Z consecutive rings of the plurality of rings along the second direction, wherein Z can be 0 or greater than 1, and Z<X, and if Z=0, attached to the next consecutive ring of the plurality of rings starting from the second X consecutive rings in the first direction, or if Z>0, attached to the next consecutive ring of the plurality of rings in the second direction, and a third suture segment attached to the same ring as the second segment of the suture (corresponding to the next consecutive ring starting from the second X consecutive rings in the first direction if Z=0, or the next consecutive ring in the second direction if Z>0) and passing through a third X consecutive rings of the plurality of rings along the first direction, skipping Y rings immediately adjacent to the third X consecutive rings along the first direction, passing through Z consecutive rings of the plurality of rings along the second direction, wherein Z can be 0 or greater than 1, and Z<X, and if Z=0, attached to the next consecutive ring starting from the third X consecutive rings in the first direction, or if Z>0, attached to the next consecutive ring in the second direction. The values may be X=3, Y=1 and Z=0, or X=4, Y=1 and Z=2, or X≥2, or X-Z=2. The first suture segment, the second suture segment and the third suture segment may comprise sequentially connected continuous sections of one continuous suture. The first suture segment, the second suture segment and the third suture segment may comprise separate sutures.

[0026] In yet another embodiment, a stent valve is provided, comprising: a one-piece stent framework, said one-piece stent framework comprising a plurality of longitudinal struts and a plurality of circumferential struts, said plurality of longitudinal struts and said plurality of circumferential struts forming a tubular inner wall having a central lumen and an outer wall surrounding said tubular inner wall, replacement valve leaflets located in the central lumen of said tubular inner wall and coupled to said tubular inner wall, a plurality of rings coupled to said one-piece stent framework, said plurality of rings being arranged at equal intervals around the circumference of said one-piece stent, a first segment of a suture tied to a first anchoring ring among said plurality of rings, said first segment of the suture passing through a first X consecutive rings among said plurality of rings adjacent to said first anchoring ring in a first direction, skipping a second anchoring ring among said plurality of rings adjacent to said first consecutive rings, passing through a first Y consecutive rings among said plurality of rings that are fewer in number than the X consecutive rings in a second direction, and tied to the ring closest to said second anchoring ring among the first X consecutive rings of said plurality of rings, a second segment of the suture passing through said second anchoring ring and a second X consecutive rings among said plurality of rings adjacent to said second anchoring ring in said first direction, skipping a third anchoring ring among said plurality of rings adjacent to said second X consecutive rings, passing through a second Y consecutive rings among said plurality of rings that are fewer in number than the X consecutive rings in said second direction, and tied to the ring closest to said third anchoring ring among said second X consecutive rings, a third segment of the suture passing through said third anchoring ring and a third X consecutive rings adjacent to said third anchoring ring in said first direction, skipping a fourth anchoring ring among said plurality of rings adjacent to said third X consecutive rings, said third segment of the suture passing through a third Y consecutive rings among said plurality of rings in said second direction, wherein Y < X, and tying said third segment to said first anchoring ring. The plurality of rings may include N rings, and wherein N is divisible by X. The values may correspond to Y=0, or wherein Y=2 and X=4.

[0027] In another embodiment, a method for laying sutures to collapse and replace a valve is provided, comprising obtaining a replacement valve, the replacement valve including an integral support frame including a plurality of longitudinal struts and a plurality of circumferential struts, the plurality of longitudinal struts and the plurality of circumferential struts forming a tubular inner wall having a central lumen and an outer wall surrounding the tubular inner wall, a replacement leaflet valve located in the central lumen of the tubular inner wall and connected to the tubular inner wall, and a plurality of rings connected to the integral support frame, the plurality of rings being equally spaced around the circumference of the integral support frame, the plurality of rings including a first anchoring ring, a first ring subset, a second anchoring ring, a second ring subset, a third anchoring ring, and a third ring subset, attaching a first segment of a suture to the first anchoring ring, and passing the first segment of the suture through a tight The first set of rings, including at least one consecutive ring adjacent to the first anchoring ring, skips the second anchoring ring immediately adjacent to the first set of rings. A first segment of the thread is passed through the second set of rings, including at least one consecutive threaded ring immediately adjacent to the second anchoring ring, and the first segment of the thread is attached to a third anchoring ring immediately adjacent to the second set of rings. A second segment of the thread is passed through the third set of rings, including at least one consecutive ring immediately adjacent to the third anchoring ring, skips the first anchoring ring, passes through the first set of rings, and is attached to the second anchoring ring. A third segment of the thread is passed through the second set of rings, skips the third anchoring ring, passes through the third set of rings, and is attached to the first anchoring ring. Each of the first, second, and third set of rings contains the same number of rings. The plurality of rings may include twelve rings, wherein the first anchoring ring may be the sixth ring of the plurality of rings, the first subset of rings may include the seventh, eighth, and ninth rings of the plurality of rings, the second anchoring ring may be the tenth ring of the plurality of rings, the second subset of rings may include the eleventh, twelfth, and first rings of the plurality of rings, the third anchoring ring may be the second ring of the plurality of rings, and the third subset of rings may include the third, fourth, and fifth rings of the plurality of rings. The plurality of rings may include N rings and X subsets of rings, where N is divisible by X+1. Each of the X subsets of rings may include Y rings. Each of the X subsets of rings does not overlap with any other X subsets of rings. The value may be Y=3 and N=12.

[0028] In another variant, a method of arranging sutures to collapse a replacement valve is provided, comprising obtaining the replacement valve, the replacement valve including a one-piece stent frame, the one-piece stent frame including a plurality of longitudinal struts and a plurality of circumferential struts, the plurality of longitudinal struts and the plurality of circumferential struts forming a tubular inner wall having a central lumen and an outer wall surrounding the tubular inner wall, replacement valve leaflets located in the central lumen of the tubular inner wall and coupled to the tubular inner wall, a plurality of rings coupled to the one-piece stent frame, the plurality of rings being equally spaced around the circumference of the one-piece stent, tying a first segment of a suture to a first anchoring ring of the plurality of rings, threading the first segment of the suture in a first direction through a first X consecutive rings of the plurality of rings immediately adjacent to the first anchoring ring, skipping a second anchoring ring of the plurality of rings immediately adjacent to the first consecutive rings, threading the first segment of the suture in a second direction through a first Y consecutive rings of the plurality of rings that are fewer in number than X consecutive rings, and tying the first segment of the suture to the ring of the first X consecutive rings of the plurality of rings that is closest to the second anchoring ring, threading a second segment of the suture in the first direction through the second anchoring ring and a second X consecutive rings of the plurality of rings immediately adjacent to the second anchoring ring, skipping a third anchoring ring of the plurality of rings immediately adjacent to the second X consecutive rings, threading the second segment of the suture in the second direction through a second Y consecutive rings of the plurality of rings that are fewer in number than X consecutive rings, and tying the second segment of the suture to the ring of the second X consecutive rings that is closest to the third anchoring ring, threading a third segment of the suture in the first direction through the third anchoring ring and a third X consecutive rings of the plurality of rings immediately adjacent to the third anchoring ring, skipping a fourth anchoring ring of the plurality of rings immediately adjacent to the third X consecutive rings, threading the third segment of the suture in the second direction through a third Y consecutive rings of the plurality of rings, wherein Y < X, and tying the third segment to the first anchoring ring. The method of claim 95, wherein the plurality of rings may comprise N rings, and wherein N is divisible by X. The value may be Y=0, or wherein Y=2 and X=4.

[0029] In another embodiment, a method of arranging sutures to collapse a replacement valve is provided, which includes obtaining a replacement valve, the replacement valve comprising a one-piece stent frame, the one-piece stent frame comprising a plurality of longitudinal struts and a plurality of circumferential struts, the plurality of longitudinal struts and the plurality of circumferential struts forming a tubular inner wall having a central lumen and an outer wall surrounding the tubular inner wall, replacement valve leaflets located in the central lumen of the tubular inner wall and coupled to the tubular inner wall, and a plurality of rings coupled to the one-piece stent frame, the plurality of rings being equally spaced around the circumference of the one-piece stent, wherein the relative positions of the rings are defined by a positive direction and a negative direction, tying a first segment of a suture to a first anchoring ring, passing the first segment of the suture in a first direction through a first X consecutive rings immediately adjacent to the first anchoring ring, where X>0, skipping Y rings immediately adjacent to the first X consecutive rings in the first direction, passing through Z consecutive rings in a second direction, where Z may be 0 or greater than 1, and Z<X, and if Z=0, tying the first segment of the suture to the next consecutive ring in the first direction, or if Z>0, tying it to the next consecutive ring in the second direction, passing a second segment of the suture in the first direction through a second X consecutive rings, skipping Y rings immediately adjacent to the second X consecutive rings in the first direction, passing through Z consecutive rings in the second direction, where Z may be 0 or greater than 1, and Z<X, and if Z=0, tying the second segment of the suture to the next consecutive ring from the second X consecutive rings in the first direction, or if Z>0, tying it to the next consecutive ring in the second direction, passing a third segment of the suture in the first direction through a third X consecutive rings, skipping Y rings immediately adjacent to the third X consecutive rings in the first direction, passing through Z consecutive rings in the second direction, where Z may be 0 or greater than 1, and Z<X, and if Z=0, tying the third segment of the suture to the next consecutive ring from the third X consecutive rings in the first direction, or if Z>0, tying it to the next consecutive ring in the second direction. In some variants, X=3, Y=1 and Z=0, or where X=4, Y=1 and Z=2, or where X≥2, or where X-Z=2. Brief Description of the Drawings

[0030] Figure 1A and Figure 1B are a schematic side elevational view and a top plan view of one embodiment of a heart valve stent; Figure 1C is Figure 1A a partial cross-sectional view of the heart valve stent, with a portion of the outer wall omitted; Figure 1D is Figure 1B a schematic cross-sectional view; Figure 1E is a schematic cross-sectional view of the inner wall of the heart valve stent, without the outer wall; Figure 1F is a schematic cross-sectional view of the outer wall of the heart valve stent, without the inner wall, and Figure 1Fyes Figure 1B A schematic cross-sectional view; Figure 1G yes Figure 1A A schematic diagram of two longitudinal support columns; Figure 1H This is a schematic side elevation view of a variant of a heart valve stent with a shorter outer wall; Figure 2A and Figure 2B The cross-sectional configurations of the supports in the outer and inner walls of an exemplary folding support structure are schematically depicted. Figure 3A and Figure 3B The cross-sectional configuration of the struts in the outer and inner walls of another exemplary folding support structure is schematically depicted; Figures 4A to 4C Various exemplary pillar configurations are depicted; Figure 5A This is a schematic side elevation view of another embodiment of a cardiac valve stent with attached leaflets, valve body and skirt. Figure 5B and Figure 5C yes Figure 5A Schematic perspective views of a cardiac valve stent from below and above; Figure 5D yes Figure 5C A schematic top perspective view of the mid-sleeve cuff structural variation; Figures 6A to 6C These are top perspective views, top plan views, and side elevation views of the skirt structure used in heart valve stents; Figure 6D yes Figures 6A to 6C Cross-sectional view of the mid-skirt structure; Figure 7A and Figure 7B These are atrial side / top views and ventricular side / bottom views of the implanted heart valve; and Figures 8A to 8E This is an exemplary schematic cross-sectional view of the deployment process of a heart valve stent and delivery system.

[0031] Figures 9A to 9C Various attachment rings located in the openings of the support structure are depicted.

[0032] Figure 10 Other exemplary attachment rings that are attached to the support structure are depicted.

[0033] Figure 11A and Figure 11B This is a schematic diagram of a support structure with embedded barbs, shown in both the flat and extended positions. Figure 11C It has Figure 11A and Figure 11B Side elevation view of the barbed support frame. Figure 11 D is a schematic part diagram of a variant with attachment tabs.

[0034] Figure 12A and Figure 12B Another embodiment of the replacement valve and stent structure, including radially oriented orifices, is described.

[0035] Figure 13A and Figure 12B Another embodiment of the replacement valve and stent structure, including a partially rotating orifice, is described.

[0036] Figure 14A and Figure 14B An embodiment including holes and rings on the inner and outer walls is described.

[0037] Figure 15 Another variation of heart valve replacement is described, which includes embedded barbs, eyelets, and valve skirt openings or incisions.

[0038] Figure 16A A schematic perspective view depicting a stent structure for a replacement valve according to one embodiment of the present disclosure is shown.

[0039] Figure 16B Depicting Figure 16A Cross-sectional view of the support structure.

[0040] Figure 17A A schematic perspective view depicting a stent structure for a replacement valve according to one embodiment of the present disclosure is shown.

[0041] Figure 17B Depicting Figure 17A Cross-sectional view of the support structure.

[0042] Figure 18A A perspective view of the skirt of a replacement valve according to one embodiment of the present disclosure is depicted.

[0043] Figure 18B Depicting Figure 18A Side view of the skirt.

[0044] Figure 19A A perspective view of a replacement valve according to one embodiment of the present disclosure is depicted, the replacement valve comprising a valve assembly clipped to a stent structure.

[0045] Figure 19B Depicting Figure 19A A detailed perspective view of the clips connecting the valve assembly to the stent structure.

[0046] Figure 19C Depicting Figure 19A and Figure 19B A cross-sectional view of the clamp and valve assembly.

[0047] Figure 20AA perspective view of a replacement valve according to one embodiment of the present disclosure is depicted, the replacement valve including a valve assembly connected to a stent structure via clips.

[0048] Figure 20B Depicting Figure 20A Cross-sectional view of the clip and valve assembly.

[0049] Figure 21A A perspective view of a replacement valve according to one embodiment of the present disclosure is depicted, the replacement valve comprising a valve assembly attached to a stent structure by clips.

[0050] Figure 21B Depicting Figure 21A Cross-sectional view of the clip and valve assembly.

[0051] Figure 22A A perspective view of a replacement valve according to one embodiment of the present disclosure is depicted, the replacement valve including a plurality of ring structures connected to a stent structure of the replacement valve.

[0052] Figure 22B Depicting Figure 22A A detailed view of one of the ring structures.

[0053] Figure 22C Depicting Figure 22A A detailed view of one of the ring structures.

[0054] Figure 22D A detailed perspective view of a replacement valve according to one embodiment of the present disclosure is depicted, the replacement valve including a plurality of ring structures coupled to the atrial side of a stent structure.

[0055] Figure 23A A perspective view of the implant retention / release assembly of a catheter delivery system is depicted, which includes a rotor / stator assembly for collapsing replacement valves.

[0056] Figure 23B Depicting Figure 23A End view of the implant retention / release components and replacement valve.

[0057] Figure 24 A schematic end view depicts a suture placement process for a collapsed replacement valve according to one embodiment of the present disclosure.

[0058] Figure 25 A schematic end view depicts a suture placement process for a collapsed replacement valve according to one embodiment of the present disclosure.

[0059] Figure 26A This is a schematic diagram of an exemplary attachment area for a tethered retaining loop or structure in the ventricular and atrial regions. Figure 26B It is oriented towards Figure 26A A schematic close-up view of the tether retention loop at the ventricular end of the stent. Figure 26C Describing the use of Figure 26B An example of a tethered retaining loop is attached to a post via a stitched attachment. Figure 26D It is oriented towards Figure 26A A schematic close-up of the tether retention loop at the strut joint in the atrial region of the stent. Figure 26E Describing the use of Figure 26D An example of a stitched attachment where a tether retainer loop is attached to a post joint. Figure 26F and Figure 26G Depicted respectively Figure 26B and Figure 26D Double or paired tethers maintain the loop deformation.

[0060] Figure 27 This is a schematic diagram of an exemplary tether attachment and loop configuration that utilizes multiple separate tethers in a non-overlapping configuration.

[0061] Figure 28 This is a schematic diagram of another exemplary tether attachment and loop configuration that utilizes multiple separate tethers in an overlapping configuration.

[0062] Figure 29 This is a schematic diagram of another exemplary tether attachment and loop configuration.

[0063] Figure 30A and Figure 30B These are schematic diagrams of other exemplary tethering and loop configurations, utilizing multiple fully circumferential tethers in unattached and attached configurations, respectively. Detailed Implementation

[0064] This embodiment relates to a double-walled, folded stent structure having an inner wall providing a tubular lumen attached 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 valvular anatomy, but continuous with 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, integral 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 delivery to the target anatomical site, and then re-expand at the implantation site.

[0065] In a further embodiment, the folded stent structure may be shaped with an intermediate region having a reduced cross-sectional size in the outer wall, which facilitates anchoring of the stent structure across the desired anatomical site. The intermediate region with a reduced diameter or size is configured to abut against the expansion of 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 facilitate fluid inflow into the lumen and through the replacement valve leaflet, while reducing turbulent and / or hemodynamic forces that could cause valve displacement or dislocation. For example, compared to a transition wall orthogonally oriented between the outer and inner walls or relative to the longitudinal axis of the stent structure, the transition wall may be radially inwardly angled or tapered from the outer wall to the inner wall to improve flow or reduce peak forces acting on the transition wall.

[0066] While some exemplary embodiments described herein relate to transcatheter mitral valve replacement, the components and structures described herein are not limited to any particular valve or delivery method and are suitable for implantation in tricuspid, pulmonary, aortic, and non-cardiac locations (e.g., aortic, venous, or cerebrospinal fluid systems, or native or artificial catheters, conduits, or shunts). As used herein, spatial references to the first or upper 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 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.

[0067] Figures 1A to 1G An exemplary embodiment of a support structure 100 in an expanded configuration is depicted. The support structure 100 includes an inner cavity 102 formed by an inner wall 104. An outer wall 106 is radially spaced from the inner wall 104 via a transition wall 108 and forms an annular cavity 110. The support 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.

[0068] The inner cavity 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 inner cavity 102 is typically aligned with the central axis of the support structure 100, but in some variations, the inner cavity may be eccentrically positioned relative to the outer wall of the support structure. For example... Figures 1A to 1DAs shown, the cavity 102 typically comprises a circular cross-sectional shape and has a generally cylindrical shape between the first opening 116 and the second opening 118. In other examples, the cavity may comprise a truncated conical, elliptical, or polygonal shape. In some variations, the support structure may include a cavity in which the dimensions and / or shapes of the first and second openings may differ. The length of the cavity 102 may range from 10 mm to 50 mm, 15 mm to 40 mm, or 20 mm to 25 mm, and the diameter or maximum cross-sectional dimension of the cavity along its longitudinal length may range from 15 mm to 40 mm, 20 mm to 30 mm, or 25 mm to 30 mm. In embodiments where the cavity comprises a non-cylindrical shape, the difference in diameter or cross-sectional dimension between the first opening 116 and the second opening 118 may range from 1 mm to 10 mm, 1 mm to 5 mm, or 1 mm to 3 mm.

[0069] The positions of the first opening 116 and the second opening 118 of the inner cavity 102 relative to the entire support structure 100 can also vary. In some variations, such as Figures 1A to 1G As shown, the first opening 116 of the inner cavity 102 may be recessed relative to the first end 112. In other examples, the first opening may be substantially flush with the first end transition wall of the support 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 joint 122 between the inner wall 104 or the inner cavity 102 and the transition wall 108, or relative to the longitudinal position of the outer joint 124 between the transition wall 108 and the outer wall 106, such as... Figure 1G As shown. Similarly, the second opening 118 of the lumen 102 can 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, for the stent structure 100, the second opening 118 of the lumen 102 includes an offset or protruding position relative to the outer opening 126 of the outer wall 106. In some variations, in variations where a smaller or shorter outer wall is preferred to accommodate a smaller-sized native valve anatomy, the lumen may protrude relative to the second opening of the outer wall. However, the lumen size can remain relatively consistent across different size variations to provide consistent valve geometry and / or hemodynamic characteristics.

[0070] The transition wall 108 of the support structure 100 has a generally annular and slightly tapering shape around the inner cavity 102 in the expanded configuration, but may have different shapes and / or surface angles in other variations. See, for example, [reference needed]. Figure 1G The transition wall 108 may, in cross-section, comprise a generally linear shape between the inner joint 122 and the outer joint 124, but in other variations may comprise 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 cavity. (See again) Figure 1GThe transition wall 108 of the support structure 100 may form an external acute angle 128 relative to the longitudinal axis 120 of the inner cavity 102. The angle 128 may be in the range of +45 to +89 degrees, +75 to +89 degrees, or +81 to +85 degrees, and optionally vary within the range of ±1 degree, ±2 degrees, ±3 degrees, or ±4 degrees. In other variations, the transition wall angle may be in the range of -45 to +45 degrees, -75 to +75 degrees, or -85 to +85 degrees.

[0071] As previously described, in some embodiments, the outer wall 106 of the support structure 100 includes a non-cylindrical shape when in an expanded configuration. The outer wall 106 may include a first end region 140 (including an externally convex shape) continuous with the transition wall 108 and a second end region 142 forming an external 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 R1 along the inner curvature of the bend, and a first or upper inner bending angle A1. The bending angle is the angle defined by the arc length of the bend from the center of the radius of curvature, i.e., the angle between points where the bend transitions to a straight segment or different bends. The outer joint 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 R2 and a second or upper outer bending angle A2. The middle region of the outer wall 108 includes a third or intermediate radius of curvature R3 and a third or intermediate bending angle A3, while the lower region of the outer wall 108 may include a fourth or lower radius of curvature R4 and a fourth or lower bending angle A4.

[0072] like Figure 1G As shown, the center point of the first radius of curvature R1 and the second radius of curvature R2 can be located inside the annular cavity 110 of the support structure 100, while the third radius of curvature R3 can be outside the outer wall 108, and the fourth radius of curvature R4 can be located in the same-side annular cavity 110, the inner cavity 102, and the opposite-side annular cavity 110b, depending on the size.

[0073] The radius of curvature and bending angle of the stent structure can be used to define the geometry of the stent in an expanded configuration, but also affect the geometry of the stent when it is in its delivery or collapsed configuration. Regions or segments of the stent can be configured to have a smaller radius of curvature and / or a larger bending angle to facilitate folding of the stent at such regions or segments, so as to transition to the delivery or collapsed configuration. A larger radius of curvature or a smaller bending angle can be provided to facilitate straightening of such regions or segments for the delivery or collapsed configuration. For example, for the stent structure 100, a relatively small radius of curvature R1 facilitates folding or collapsing of the stent structure at the inner junction 122, while a larger radius of curvature R2 facilitates flattening of the first end region 140 during device delivery or loading into a delivery system. Thus, in the collapsed configuration, the transition wall 108 bends further at the inner junction 122 and collapses about the inner wall 104. The outer wall 106 also collapses about the inner wall 104, but does not collapse about 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 relatively large radii of curvature R3 and R4, which will cause the concave shape of the intermediate region 142 and the convex shape of the second end region 144 to flatten, likewise facilitating collapsing of the outer wall 106. Thus, for the stent structure 100 in its collapsed configuration, the inner wall 104 will be located radially inward relative to the outer wall 106 and the transition wall 108. The outer wall 106 and the transition wall 108 will contact the sheath, balloon or outer wall of the delivery system, while the inner wall 104 may contact the inner core or inner catheter wall. In other embodiments, the stent structure may be provided with a relatively large radius of curvature R1 and a relatively small radius of curvature R2, such that in the collapsed configuration, the transition wall collapses proximally against the delivery device rather than against the inner wall 104, and wherein the outer wall 106 collapses against both the inner wall 104 and the transition wall 108.

[0074] In some variations, the stent geometry may be characterized by one or more relative features when the stent is in its expanded configuration. For example, the stent structure 100 may be characterized as A3>A1 and A3>A2 and A3>A4, and / or R1<R2<R2<R4, R1<R2≈R3≤R4, R1<R2≈R3≈R4, or R1<R2≤R3≤R4.

[0075] Other stent variations may include: 1) R2<R1<R3<R4; 2) R2<R1≈R3<R4; 3) R2<R1≈R3≈R4; 4) R4>R1≈R2; 5) R4>R1≈R2>R3; 6) The ratio of A2:A1 is in the range of 1 to 3, 1.5 to 2.5, or 1.8 to 2.2; 7) The A3:A4 ratio is in the range of 1 to 4, 1.5 to 3.0, or 2.2 to 2.4; 8) The A2:A4 ratio is in the range of 2 to 4, 2.5 to 3.5, or 2.8 to 3.2; like Figures 1A to 1G As shown, the support structure of this paper also includes multiple integrally formed support column segments. Some columns can be characterized as longitudinal column segments 130a, 130b, 130c, which are typically located in a radial plane, in which the longitudinal axis of the support structure also lies, or as transverse column segments 134a, 134b, 134c, which are integrally formed with the longitudinal columns 130a, 130b, 130c, 132a, 132b, 132c, wherein two longitudinal columns 130 and 132 are located in different adjacent radial orientation planes. In embodiments with an even number of equally spaced longitudinal columns, such as Figure 1G As shown, each radial plane 150 will include the longitudinal axis 120 of the support structure 100 and two longitudinal struts 130, 136 located on opposite sides of the support structure 100. The longitudinal and transverse strut segments may be further grouped, wherein a group of longitudinal strut segments located in the same radial plane forms a continuous length of longitudinal struts 130, 132 in the inner wall 104, transition wall 108 and / or outer wall 106.

[0076] Figure 1H Another embodiment of the support structure 150 is depicted, similar to support structure 100, except that its outer wall 152 has a shorter longitudinal length, thus the inner wall 154 extends further relative to the open end 156 of the outer wall 152, and wherein the transverse strut 158 ​​located at the open end 156 of the outer wall 152 is radially outwardly curved relative to the adjacent longitudinal strut 160. In some variations, the radial distance from the center 162 of the transverse strut 158 ​​to a position 164 corresponding to the position of the center 162 of the transverse strut 158 ​​when it is not radially outwardly shifted (e.g., the midpoint between the two nearest positions of the two nearest longitudinal struts 160a, 160b) is in the range of 2 to 10 mm, or 3 to 8 mm, or 3 to 5 mm. This feature of the transverse struts increasing radially outwardly can also be provided in any other support structure embodiment herein.

[0077] In some examples, a longitudinal strut (comprising multiple consecutive longitudinal strut segments) positioned within one wall may terminate or be interrupted at the junction of the next wall, but in some embodiments, it may span two or three walls. In some further embodiments, the longitudinal strut may be positioned along the entire folded length of the support structure, between the inner cavity opening, along the length of the inner wall, and through the transition wall and outer wall to the end of the outer wall, while still ensuring that each consecutive strut segment lies within the same radial plane 150, such as... Figure 1GThe longitudinal struts 130 and 152 are shown. It is presumably that this arrangement of multiple continuous longitudinal struts throughout the folded support structure provides structural integrity and better redistributes forces acting on the support structure, resulting in less force concentration compared to support structures composed of multiple components welded or attached together during manufacturing or use. In some other examples, the continuous length of the longitudinal struts may span all three walls, but the support may include different strut configurations at one or both of the inner and outer ends of the folded support structure, such as different orientations of circumferential struts or tissue anchors.

[0078] In the exemplary stent structure 100, the longitudinal strut segments along the lumen of the stent structure 100 include a linear configuration, so that the longitudinal strut segments are generally parallel in their expansion and contraction configurations. Due to this arrangement, the lumen 102 does not exhibit any shortening when changing from a contraction configuration to an expansion configuration. This reduces or eliminates any axial stretching of the valve structures attached to the lumen. This also allows the lumen to be positioned and expanded predictably while reducing the risk of unintended displacement.

[0079] While the non-cylindrical configuration of the outer wall 106 may exhibit some shortening as it transitions from a relatively straight orientation in its contraction configuration to an hourglass shape or convex / concave / convex profile in its expansion configuration, the shortening effect may be uneven or asymmetrical, thus altering the relative positions of certain features of the outer wall 106. This can be mitigated by adjusting the angular orientation of the transition wall 108, which subsequently shifts the outer wall 106 toward or away from the inlet opening 116 of the stent structure 100 and counteracts some longitudinal displacement of the outer wall 106 due to shortening. This, for example, allows the reduced-diameter midsection of the outer wall 106 to maintain approximately the same relative longitudinal position relative to the entire length of the stent or relative to the valve position within the stent before and after expansion. This, in turn, can help maintain the intended implantation position during delivery. In some variations, the longitudinal offset of the reduced-diameter midsection of the outer wall during stent structure expansion may be less than 5 mm, 4 mm, 3 mm, 2 mm, or 1 mm.

[0080] A transverse strut segment can also be characterized by a set of continuous transverse strut segments that form partial or complete circumferential or perimeter struts around the walls of the support structure. However, the transverse strut segments can vary not only in their circumferential orientation. To facilitate the expansion and contraction of the entire support structure, one or more, or all, of the transverse strut segments may include a pair of angled legs, each lateral end of which is continuous or integral with a longitudinal strut segment or strut, and wherein each angled leg joins together centrally. While a curved configuration formed by two angled legs may include a simple bend, in other examples, each leg may extend centrally to form a hairpin bend region.

[0081] The leg angle formed between each leg and the longitudinal support can vary in different areas of the support structure and can vary depending on the leg length. Figure 4A The diagram illustrates an exemplary configuration of transverse support segments within the inner wall of a support structure. Because the inner wall exhibits a relatively small radial expansion relative to the outer wall, the leg length of the inner wall in the expanded configuration is typically shorter than that of the legs in the outer wall. Furthermore, due to the limited radial expansion, the legs in the inner wall can have a generally linear configuration because the structural strain generated at the leg angles is limited. (See reference...) Figure 4B and Figure 4C In other areas of the support structure, where a large amount of radial expansion occurs (e.g., the outer wall and potential transition walls), each leg may include a convex curvature along an acute leg angle and a concave curvature along an acute leg angle near the intermediate bend region.

[0082] In some embodiments, the transverse support segments in the inner wall may include acute leg angles less than 50 degrees, 45 degrees, or 40 degrees, or within the range of 30-50 degrees, 35-45 degrees, or 35-40 degrees, while the acute leg angles in the outer wall may be within the range of 30-75 degrees, 30-60 degrees, 35-55 degrees, or 40-50 degrees. The longitudinal spacing between adjacent transverse support segments in the inner cavity may be smaller 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 for the inner wall, and 4-10 mm, 5-10 mm, or 6-9 mm for the outer wall. This spacing is also the length of the longitudinal support segment in each wall region.

[0083] Reference Figure 1GThe orientation of the legs and intermediate bends of one or more sets of circumferential strut segments may also be radially outward relative to adjacent longitudinal struts to provide barbed or force-concentrating structures that resist displacement of the strut structure relative to the native valve tissue. The barbed transverse struts may be located anywhere on and / or around the outer wall of the stent structure, but in some variations, they may be located in outer wall regions 142 and 144, between the reduced diameter region 142 and the outer opening 126 of the stent structure 100, and oriented towards the reduced diameter region 142. In some further examples, radially outward-displaced circumferential struts may be positioned at one or more circumferential struts closest to and pointing towards the smallest diameter region of the outer wall. In valve variations used for mitral valve replacement, barbs may be formed in the struts to engage the subannular tissue on the ventricular side. In some examples, each transverse strut segment in the circumferential struts is radially displaced, but in other examples, any range of 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, or any two of these numbers may be radially displaced, or every other transverse strut segment, every three, or every four may be radially displaced. The degree of protrusion relative to the outer wall shape defined by the multiple longitudinal struts may range from 2-10 mm, 2-6 mm, or 2-4 mm. In some variations, the barb configuration may be characterized by the ratio of the radial distance between the barb tip and the longitudinal axis of the support structure to the radial distance between the adjacent longitudinal strut or outer wall segment (excluding the barb) and the longitudinal axis of the support structure. This ratio may range from 1.1 to 1.5, 1.05 to 1.30, or 1.10 to 1.20.

[0084] like Figure 1G As shown, barbs may include extensions of the transverse struts, which may be located at the centerline of the transverse struts. However, in other variations, barbs may be provided on the longitudinal struts or other struts of the support frame. For example, Figure 11A and Figure 11BA longitudinal barb 1114 is depicted, which may optionally be adapted to any support frame embodiment herein. The barb 1114 is located within an elongated cavity or opening 1116 of the support post 1110. The length of the barb 1114 may range from about 1 mm to 10 mm, 2 mm to 8 mm, or 3 mm to 6 mm, and the width may range from 0.05 mm to 3 mm, 0.1 mm to 1 mm, or 0.1 mm to 0.5 mm. The tip 1118 of the barb may be pointed or rounded. The orthogonal distance between the tip 1118 of the barb 1114 and the elongated opening 1116 may range from 1 mm to 10 mm, 2 mm to 8 mm, or 3 mm to 6 mm. The length of the elongated cavity may range from 3 mm to 15 mm, 4 mm to 12 mm, or 2 mm to 7 mm, and the width may range from 1 mm to 4 mm, 1 mm to 3 mm, or 0.4 mm to 2 mm. The lateral clearance between the side of the barb 1114 and the side of the opening 1116 can be in the range of 0.05 mm to 2 mm, 0.1 mm to 1 mm, or 0.1 mm to 0.5 mm. The distal clearance between the end 1118 of the barb 1114 and the opening 1116 can be in the range of 0.05 mm to 2 mm, 0.1 mm to 1 mm, or 0.1 mm to 0.5 mm. The width of the support 1110 can be increased in the segment or region where the barb 1114 and the opening 1116 are embedded, relative to the width of the support where the barb 1114 and the opening 1116 are not present. Figure 11A and Figure 11B The exemplary embodiment depicted is located at one end of the longitudinal strut 1110, at the junction between the two transverse struts 1112, but in other variations, the barb 1114 may be located along the longitudinal strut 1110 at a junction spaced apart from the end of the longitudinal strut 1110, or at a location spaced apart from the junction of the transverse struts 1112. Figure 11C A support structure 1120 is depicted, which has embedded barbs 1114 and elongated openings 1116 at each end of longitudinal struts 1110 on the outer wall 1122.

[0085] In some further examples, control holes or attachment structures may be provided on the strut segments or at the joints between two or more strut segments. Control holes may be used to releasably attach tension members, including but not limited to sutures, wires, and hooks, which can be relaxed or tensioned to control the expansion, contraction, release, or loading of the stent structure during valve prosthesis delivery or loading of the valve prosthesis into its delivery system. Various embodiments of the delivery system and method are described in more detail below. (Refer to...) Figure 1EIn the example, control holes are optionally located at the junction of the ends of each continuous longitudinal strut in the outer and inner walls. Additionally, control holes may optionally be located in the intermediate bend of one or both of the two circumferential struts closest to the outer opening 126 of the outer wall 106.

[0086] In another variation, such as Figure 11 As shown in Figure D, the end of the longitudinal strut 1110 includes an attachment 1130 projecting from the end of the strut 1110 via an attachment neck 1132. The attachment 1130 and neck 1132 can be disposed on one, two, three, four or more, or all of the longitudinal struts of the support frame, located on the inner and / or outer walls. The attachment 1130 and neck 1132 structure can be used to retain or otherwise engage the delivery system when rigid attachment is preferred over tension wire attachment. Here, the attachment 1130 includes a hemispherical shape, but in other variations, the head can be polygonal, square, rectangular, circular, elliptical, triangular, star-shaped, or other shapes. Figure 11 In the exemplary embodiment depicted in D, the head and neck structures 1130, 1132 are disposed on the strut 1110, which also includes embedded barbs 1114 and barb openings 1116, but these two features need not be included together; the head structure 1130 and neck structure 1132 may be incorporated into any support structure herein.

[0087] Figure 12A and Figure 12B Another embodiment of the stent structure or replacement valve 1200 is depicted, comprising an attachment structure disposed at one end of a longitudinal strut 1204 of the valve 1200, the attachment structure having an elliptical or circular orifice 1202 connected via an orifice extension or neck 1206, the orifice 1202 having a circular opening 1208. In this exemplary embodiment, the orifice 1202 is disposed on the strut 1204 of the inner wall 1210, and a ring 1212 is also attached to each orifice 1202. The ring 1212 may be used to facilitate the threading of a delivery line or a loop 1214, because the radially inward / outward orientation of the opening 1208 of the orifice 1202 may tension the delivery line 1214 to increase friction during valve 1200 collapse and / or loading.

[0088] Figure 13A and Figure 13B Another embodiment of the stent structure or replacement valve 1300 is depicted, which includes an attachment structure disposed at one end of a longitudinal strut 1304 on the inner wall 1310 of the valve 1300. This attachment structure also has a circular orifice 1302 connected via an extension or neck 1306, the orifice 1302 having a circular opening 1308. However, this exemplary embodiment is different from... Figure 12A and Figure 12BThe difference in the depicted valve 1200 is that the orifice 1302 is rotated by 30 to 45 degrees. This is achieved by twisting the neck 1306 of the orifice 1302. This rotation reorients the orifice opening 1308, making it partially circumferential or tangentially oriented towards other adjacent orifices, thereby reducing friction between the orifice 1302 and the delivery line or ring 1314, so that it is not needed or unlike the valve 1200 (as described in the image). Figure 12A and Figure 12B The ring is attached to each eyelet 1302 in the same manner as in the middle. In other variations, the eyelet neck 1306 can be twisted in the range of about 15 to 90 degrees, or 30 to 60 degrees, although a larger twist angle is expected to reduce the strength of the eyelet neck. A greater number of smaller heating / deformation steps can be used during manufacturing to increase the twist angle while minimizing the reduction in structural integrity.

[0089] exist Figures 12A to 13B In the exemplary valve embodiments 1200 and 1300, the orifices 1202 and 1302 are located only on the inner walls 1210 and 1310 of the valves 1200 and 1300, respectively. However, in other variations, such as Figure 14A and Figure 14B As shown, the replacement valve and stent structure 1400 may include orifices 1402, 1420 and rings 1404, 1424 located on both the inner wall 1410 and the outer wall 1422 of the valve 1400, or optionally, orifices 1402, 1420 and rings 1404, 1424 may be included only on the outer wall 1422. The orifices 1420 and rings 1424 of the outer wall 1422 may otherwise be configured with variations and configurations of the same range as those of the orifices 1202 and rings 1212 of the inner wall 1210. In such embodiments, a second or separate tension line or ring 1426 may be provided through the orifices 1420 or rings 1424 of the outer wall 1422 relative to the rings 1414 of the inner wall 1410. However, in the case of... Figure 14B In other depicted embodiments, a single ring 1430 may be provided, passing through the openings 1402, 1420 or rings 1404, 1424 of both the inner wall 1410 and the outer wall 1422. In this embodiment, the ring 1430 may or may not pass through each opening 1402, 1420 of the valve 1400. For example, in Figure 14B In this embodiment, while each of the orifices 1420 in the outer wall 1422 of the valve 1400 is looped or threaded, only every three (four in total) of the orifices 1402 in the inner wall 1410 are looped. In this type of embodiment, only three orifices 1402 may be provided on the inner wall 1410. Therefore, in this type of embodiment, the valve 1400 may only have orifices where it is used. In some variations, the number of outer wall orifices may be the same as, fewer than, or more than, the number of outer wall orifices looped with delivery rings relative to the number of inner wall orifices.

[0090] Figure 4A An example of a strut configuration 400 that can be mounted on a region or wall of a support structure is schematically depicted. The strut configuration 400 includes longitudinal struts 402, 404 and transverse struts 406, 408. The longitudinal strut segments 402a, 404a and the transverse strut segments 406, 408 together form the closed perimeter of the support opening or cell 410. To characterize the various geometric configurations of the strut configuration, the longitudinal axis 410 and the transverse axis 412 are described herein, but those skilled in the art will understand that other reference points or axes may also be used. The longitudinal axis 410 is parallel to the longitudinal axis of the entire support structure, while the transverse axis 412 is orthogonal to the longitudinal axis 410.

[0091] exist Figure 4A In the depicted schematic support configuration 400, the longitudinal supports 402 and 404 may be parallel or non-parallel, depending on whether the inner cavity includes a cylindrical or non-cylindrical shape, such as a truncated conical shape. In a variation where the longitudinal supports are not parallel, the longitudinal supports 402 and 404 may have a small radial angular orientation of approximately 1-5 degrees, 2-10 degrees, or 5 to 30 degrees relative to the longitudinal axis of the support structure to provide a truncated conical shape. Figure 4AAs shown, the longitudinal and transverse struts 402, 404, 406, and 408 may include strut segments 402a, 402b, 404a, 404b, 406a, 406b, 408a, and 408b. In some variations, within the inner wall 104 of the support structure 100, the legs 406a, 406b, 408a, and 408b of the transverse struts 406 and 408 may include a generally linear or straight configuration, with deformation primarily occurring at the bases 406c, 406d, 408c, and 408d of each transverse strut and at the bends 406e and 408e. In some variations, where greater rigidity is required, the transverse struts may be generally non-uniform along their length. This is achieved by increasing the relative width near the base of the strut and decreasing the relative width in the middle of the strut. In this support configuration 400, the acute angles 414a, 414b, 416a, 416b between the longitudinal supports 402, 404 and the legs 406a, 406b, 408a, 408b can be in the range of 1-45 degrees, 10-40 degrees, or 20-35 degrees. In some variations, the intermediate region formed integrally with the paired legs may include a simple angle or a curved configuration, but in other variations, it may include curved regions 406e, 408e with an arcuate structure, having a larger curvature 406f, 408f on the same side as the acute angle of the transverse support, and a smaller curvature 406g, 408g on the obtuse angle side of the transverse support. The curved recess 408h of each curved region 406e, 408e includes a longitudinal length and a transverse width at the smaller curvature 406g, 408g. In some variations, these lengths and widths may be configured to assist in the distribution of forces when the support structure contracts to its collapse or delivery configuration. In some examples, the curved recess may include a longitudinal length in the range of 50-500 micrometers, 50-300 micrometers, or 50-250 micrometers, and a lateral width in the range of 50-500 micrometers, 50-350 micrometers, or 100-300 micrometers.

[0092] In some implementations, the configuration of the transverse struts can vary regarding the orientation of the bend region and the relative configuration between the transverse and longitudinal struts. Figure 4A In the exemplary strut configuration 400, both bend regions are oriented toward the transition end or otherwise "point" toward the upstream end of the valve, but in other variations, one or more bend regions may be oriented toward the open or downstream end of the valve relative to the transverse strut leg.

[0093] Figure 4BAnother exemplary embodiment of the support configuration 430 is depicted, which includes longitudinal struts 432, 434 and transverse struts 436, 438. The longitudinal strut segments 432a, 434a and the transverse strut segments 436, 438 together form the closed perimeter of the support opening or cell 440. Here, the legs 436a, 436b, 438a, 438b of the transverse struts 436, 438 may include a curved or bent 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, 438e. In some variations, the convex / concave configuration allows for a greater amount of expansion from the delivery configuration to the expanded configuration, and / or allows for a more uniform distribution of stress and strain along the entire length of the strut legs. The angles 444a, 444b, 446a, 446b between the longitudinal struts 432, 434 and the straight or intermediate portions of each leg 436i, 436j, 438i, 438j can be in the range of 25-135 degrees, 45-90 degrees, or 30-60 degrees. The curved regions may also include curved recesses 436h, 438h having a longitudinal length and a transverse width, which can be configured to adjust the force and force distribution of the support in its delivery and expansion configuration. One or more curved regions 436e, 438e of each transverse strut 436, 438 may also optionally include control holes 436k, 438k as elsewhere herein. Figure 4B In the middle, the leg sections 436a, 436b, 438a, 438b and the curved areas 436e, 438e are also oriented in the same direction, but... Figure 4C In the middle, the leg bends 466a, 466b, 468a, and 468b are oriented in opposite directions.

[0094] Each support segment, or continuous length of a longitudinal or transverse support, is characterized by its transverse width or dimension, radial height or dimension, and cross-sectional shape. The shape can be approximately square, rectangular, trapezoidal, or other polygonal, circular, or oval. The transverse width or dimension of each support segment can be configured to provide different levels of radial force, with larger widths providing larger forces and smaller widths providing smaller forces. In variations where the support structure is laser-cut from a tubular foundation, the cross-sectional shape of the support segment relative to its elongated length can include segmented annular shapes, such as… Figures 2A to 3B As shown. In Figure 2A and Figure 2BIn a specific exemplary embodiment, supports 200a and 200b represent supports from the outer and inner walls of the support structure, respectively. The inner wall support 200b includes a segmented annular shape, having an outwardly convex curvature 202b furthest from the longitudinal axis of the support structure (this outward curvature is also its larger or longer curvature) and an inwardly concave curvature 204b closer to the longitudinal axis of the support structure (this inward curvature is also its smaller or shorter curvature). The side surfaces 206b and 208b are generally linear in cross-section, but their angular axes 210b and 212b are generally orthogonal to the longitudinal axis of the support structure. The outer wall support 200a may initially include the same or similar orientation as the inner wall support 200b, but in embodiments where the outer wall is formed by an outward flare, the outer wall support 200a will have an outward flare orientation such that its outward curvature 202a relative to the longitudinal axis of the support structure is concave and is also its smaller curvature, while the inward curvature 204a closer to the longitudinal axis of the support structure is convex and its larger curvature is concave. Side surfaces 206a and 208b have angular orientations that are inclined relative to the longitudinal axis of the support structure; for example, the angular axes 210a and 210b of side surfaces 206a and 208a do not intersect with the longitudinal axis of the support structure. A significant feature of these configurations is that they are located in different regions of the same longitudinal support column in the integrated folding support structure formed by the outward folding. In the integrated folding support structure formed by the outward folding, the corresponding transition wall support column, in its expanded state, will have a configuration similar to that of the outer wall support column 200a.

[0095] Figure 3A and Figure 3B Another embodiment of the folding support structure is depicted, which has a set of configurations of pillars in the outer and inner walls, which are generated by laser-cutting the tube inward to form the inner cavity and inner wall, rather than... Figure 2A and Figure 2B The depicted outward-flaring configuration. In Figure 3A and Figure 3BIn this design, supports 300a and 300b represent supports originating from the outer and inner walls of the support structure, respectively. The outer wall support 300a comprises a segmented annular shape, having an outwardly convex curvature 302a furthest from the longitudinal axis of the support structure (this outward curvature is also its larger or longer curvature) and an inwardly concave curvature 304a closer to the longitudinal axis of the support structure (this inwardly concave curvature is also its smaller or shorter curvature). Side surfaces 306a and 308a are generally linear in cross-section, but their angular axes 310a and 312a are generally inclined or do not intersect with the longitudinal axis of the support structure. The inner wall support 300b may initially include the same or similar orientation as the outer wall support 300a, but in embodiments where the inner wall is formed by inward turning, the inner wall support 300b will have an inwardly turned orientation such that its outward curvature 302b relative to the longitudinal axis of the support structure is concave and is also its smaller curvature, while its inward curvature 304b closer to the longitudinal axis of the support structure is convex and its larger curvature is concave. Side surfaces 306b and 308b have angular orientations that are inclined or non-intersecting with the longitudinal axis of the support structure. Similar to the outward-folding configuration of the folded support structure, these outer and inner wall configurations are located in different regions of the same longitudinal strut in the integral folded support structure formed by inward folding. In the integral folded support structure formed by inward folding, the corresponding transition wall strut will have a configuration similar to the outer wall strut 200a in its expanded state. In some variations, the radial force generated in the outer wall of the support structure of the inward-folding support structure may be greater than that of the outward-folding support structure, because the outward or inward folding process may weaken or adversely affect that part of the support structure (compared to parts that have not undergone outward or inward folding).

[0096] The edges of polygonal pillars can be rounded, smooth, or sharp. Figure 2A and Figure 2B In the middle, corners 214a-220b include clearly defined angular edges, while... Figure 3A and Figure 3B In the design, the corner edges 314a-320b include rounded corners. Rounded corners and edges can be formed using mechanical polishing, chemical electropolishing, or a multi-step combination thereof (e.g., mechanical polishing followed by chemical or electropolishing). In some variations, polishing may be performed prior to any inward or outward turning of the laser-cut tube. The size and / or shape of the support segment or support may be uniform or variable along its length. The radial thickness and / or circumferential width of the support may range from 300-500 micrometers, 360-460 micrometers, or 400-500 micrometers. The support thickness and / or width may be uniform or non-uniform along the length of the support segment. As previously mentioned, in some examples, a relatively larger width may be provided at the base of the circumferential support segment, and a relatively smaller width may be provided near the intermediate bend region.

[0097] The spacing between adjacent longitudinal or circumferential supports can be equal or varied throughout the folding support structure. For longitudinal supports, the number of supports can vary depending on the desired flexibility or radial expansion force of the support structure, or based on the desired support segment width to achieve the desired radial expansion force or flexibility. For circumferential supports, relatively larger spacing can be used in areas where greater radial expansion and / or less expansion force is desired, and smaller spacing can be used in areas where less radial expansion and / or greater expansion force is desired.

[0098] The various scaffold structures described herein may include one or more of the following features 1) The net longitudinal support length (i.e., the maximum distance the support spans along the longitudinal axis) is in the range of 15-60 mm, 20-40 mm, or 25 to 35 mm; 2) The length of the folded longitudinal support (e.g., the longitudinal length of a continuous longitudinal support end to end if fully straightened) is in the range of 40-100 mm, 50-90 mm, or 60-80 mm. 3) The maximum support diameter or lateral dimension in the expanded configuration is in the range of 20-80 mm, 30-60 mm, or 45-55 mm; 4) The maximum outer diameter or lateral dimension in the expanded configuration is in the range of 25-75 mm, 35-65 mm or 48-58 mm; 5) The diameter or lateral dimension of the maximum transition end in the expanded configuration is in the range of 20-80 mm, 25-55 mm or 40-50 mm, and optionally 0-20 mm, 1-15 mm, 2-10 mm, 2-8 mm or 2-5 mm smaller than the diameter or lateral dimension of the maximum outer end or the maximum support. 6) The inner cavity length is in the range of 10-50 mm, 15-40 mm, or 20-26 mm; 7) The inner cavity diameter or maximum cross-sectional dimension is within the range of 10-40 mm, 15-35 mm, or 26-31 mm; 8) The inner upper curvature radius R1 is in the range of 1-10 mm, 2-8 mm or 3-5 mm; 9) The inner upper bending angle is within the range of 0-180 degrees, 60-135 degrees, 75 to 90 degrees, or 83 degrees; 10) The external angle of the transition wall relative to the longitudinal axis of the support structure is within the range of 0-180 degrees, 45-100 degrees, 75-90 degrees, or 90 degrees; 11) The radial width of the transition wall is in the range of 5-30 mm, 5-20 mm, or 5-10 mm; 12) The outer upper curvature radius R2 is in the range of 0.5-6 mm, 1.5 to 5 mm, or 2.5 to 4 mm; 13) The outer upper bending angle A2 is within the range of 45-270 degrees, 90-235 degrees, 135-200 degrees, or 160 to 200 degrees; 14) The longitudinal length of the outer wall is in the range of 10-40 mm, 20-35 mm, or 25-30 mm; 15) The length of the outer wall curve is in the range of 10-50 mm, 20-50 mm or 30-40 mm; 16) The length of the longitudinal support column from the outer end to the transition wall is in the range of 12-50 mm, 20-40 mm or 25-35 mm; 17) The radius of curvature of the middle region of the outer wall is 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 within the range of 10-180 degrees, 30-160 degrees, 60-160 degrees or 80-140 degrees; 19) The radius of curvature R4 of the open end region or lower region of the outer wall is in the range of 5-100 mm, 5-40 mm, or 10-20 mm; 20) The bending angle A4 of the open end area or lower area of ​​the outer wall is within the range of 1-90 degrees, 10-90 degrees, 20-80 degrees or 30-70 degrees; 21) The maximum radial difference between the minimum and maximum radii in the same radial plane of the outer wall of the support structure is in the range of approximately 6-15 mm, 8-12 mm, 9-11 mm, or approximately 10 mm; 22) The maximum radius of the first end of the outer wall / atrium / superior region is within the range of 20-30 mm, 22-28 mm or 24-27 mm; 23) The minimum radius of the middle area of ​​the outer wall is in the range of 10-30 mm, 12-25 mm or 15-20 mm; 24) The maximum radius of the second end / ventricle / lower region of the lateral wall is in the range of 20-35 mm, 25-30 mm or 26-29 mm; 25) The ratio of longitudinal length to diameter is in the range of 0.40 or 1.0, 0.45 to 0.80, or 0.50 to 0.60; 26) The number of longitudinal supports is divisible by 3, for example, one or more selected from 3, 6, 9, 12, or 15 longitudinal supports; 27) The ratio of the radial distance between the barb tip and the longitudinal axis of the support structure to the radial distance between the adjacent longitudinal support or outer wall segment (excluding the barb) and the longitudinal axis of the support 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) The position of the inner opening relative to the outer opening along the longitudinal axis 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 within 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.

[0099] The scope of stent structures described in this article is not limited to requiring the selection of every feature mentioned above; single features or subsets of features are also envisioned. For example, in some variations, the stent structure (with or without valve and / or skirt material) may be: 1) A foldable integrated support structure with an outward-folding outer wall support configuration or an inward-folding inner wall support configuration; 2) A foldable integrated support structure, wherein the number of longitudinal supports is divisible by 3; having a non-shortened inner cavity and optionally a shortened outer wall, with radial support thickness in the range of 400-450 micrometers and longitudinal length to diameter ratio in the range of 0.50 to 0.60; 3) A foldable integrated support structure, comprising an inner upper curvature radius smaller than the outer upper curvature radius, an inner cavity extending 0 to 3 mm from the outer opening of the outer wall, and a barb-to-outer wall radius ratio in the range of 1.1 to 1.2; or 4) Folded double-wall integrated support structure, with 12 longitudinal supports and 3-5 circumferential supports in the inner cavity, 1-2 circumferential supports in the transition wall, and 3-5 circumferential supports in the outer wall.

[0100] exist Figures 1A to 1GIn the depicted embodiment, the support structure 100 includes a plurality of end-to-end longitudinal struts and a plurality of circumferential transverse struts, each of which includes a set of continuous longitudinal or transverse strut segments. In a specific example of the support structure 100, there are twelve equally spaced end-to-end longitudinal struts and nine complete sets of circumferential struts along the folded support structure 100. Four sets of closely spaced circumferential struts are provided along the inner wall, having relatively straight or minimally curved legs, with their intermediate bends oriented toward the upper or closed end of the support structure. The transition wall 108 includes a set of circumferential struts, each leg having a relatively increased base curvature and a relatively decreased curvature at the intermediate bend, oriented radially outward toward the outer wall 106. The outer wall 106 includes four sets of circumferential struts, with their intermediate bends oriented toward the closed end of the support 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 support structure 100. The orientation of the legs and mid-bend of the third group of circumferential struts is also radially outward relative to the adjacent longitudinal struts to provide barbed or force-concentrating structures, thereby resisting displacement of the strut structure relative to the native valve tissue. Typically, these radially outward-displaced circumferential struts are positioned at one or more circumferential struts closest to the narrowest diameter of the outer wall between the downstream or open end of the stent structure, and oriented towards the narrowest diameter of the stent structure or the inlet / upstream end, such as... Figure 1A and Figure 1C As shown.

[0101] As mentioned above, control holes are also provided at the outer end of the support structure 100, or at the junction of the longitudinal and circumferential supports at the outer end, and at the inner end of the support structure, or at the junction of the longitudinal and circumferential supports at the inner end, located within the inner cavity. Control holes are also provided at the middle bend of the two circumferential supports closest to the outer end of the support structure 100.

[0102] For the support structure 100, the net longitudinal support length can be 25 to 35 mm, the folded longitudinal support length can be 60 to 90 mm, the maximum support diameter or lateral dimension in the expanded configuration can be 45 to 55 mm, the maximum outer end diameter or lateral dimension in the expanded configuration can be 45 to 55 mm, the maximum transition end diameter or lateral dimension in the expanded configuration can be 40 to 50 mm, and can be 1 to 5 mm smaller than the maximum outer end or maximum support diameter or lateral dimension, the inner cavity length can be 20 to 25 mm, the inner cavity diameter or maximum cross-sectional dimension can be 20 to 30 mm, the inner upper curvature radius can be 3 to 5 mm, the inner upper bending angle can be 90 to 105 degrees, the outer angle of the transition wall relative to the longitudinal axis of the support structure can be 75 to 90 degrees, the radial width of the transition wall can be 15 to 20 mm, the outer upper curvature radius can be in the range of 1 to 4 mm, the outer upper bending angle can be 160 to 200 degrees, and the longitudinal length of the outer wall can be 20 to 25 mm. The outer wall curve length can be 25-40 mm, the length of the longitudinal support of the outer wall from the outer end to the transition wall can be 25-35 mm, the radius of curvature of the middle area of ​​the outer wall can be 3-6 mm, the bending angle of the middle area of ​​the outer wall can be 60-120 degrees, the radius of curvature of the open end area or lower area of ​​the outer wall can be 10-50 mm, 10-30 mm or 10-20 mm, the bending angle of the open end area or lower area of ​​the outer wall can be 20-135 degrees, 30-90 degrees or 50-70 degrees, the maximum radial difference between the minimum radius and the maximum radius in the same radial plane of the support structure can be 9-11 mm, and / or the position of the inner opening relative to the outer opening along the longitudinal axis can be -6 to -9 mm.

[0103] exist Figures 1A to 1F The stent structure 100 also includes twelve continuous longitudinal struts and nine circumferential struts, as is present in stent structure 100. Stent structure 100 includes four circumferential struts along the lumen 102, but in other variations, it may have two, three, five, or six circumferential struts within the lumen. While the orientation of the circumferential struts in the inner wall 104 also points towards the closed end of stent structure 100, and the circumferential struts of the transition wall 108 are oriented radially outward, in some variations, one or more circumferential struts may be oriented radially inward and / or toward the open end of the stent structure, such as the circumferential strut closest to the open end of the outer wall. Other optional variations may include a transition wall orthogonally oriented relative to its longitudinal axis, while the transition wall 108 of stent structure 100 is slightly or significantly angled. It is presumably that an inwardly angled transition wall can reduce turbulent or non-laminar flow into the lumen opening, or can reduce the peak axial force that displaces the stent structure from its target location during atrial contraction.

[0104] In several embodiments herein, the upper end or transition end of the stent structure is configured to serve as the upstream end of a replacement valve, with blood flow received in the lumen of the transition end and passed through the valve structure attached to the lumen. The valve structure can be any of a variety of valve structures, including winged valves, cage-ball valves, or leaflet valves. Leaflet valve materials can include autologous, allogeneic, xenogeneic, or artificial materials, such as natural materials or anatomical structures, such as pericardial tissue or valves from pigs, cattle, or horses, or biomaterials derived from the patient's own cells, and can be fixed with various chemicals (such as glutaraldehyde) to reduce the antigenicity of the valve and / or alter the physiological and / or mechanical properties of the valve material. In the case of a leaflet valve, the leaflet valve can be a bileaflet or trileaflet valve structure. The commissure of the valve can be attached or sutured to longitudinal and / or circumferential struts of the lumen; for example, stent structure 100 has trileaflet valves every four longitudinal struts.

[0105] The replacement valve may also include one or more skirt materials attached to one or more regions of the stent structure. The skirt material may include a solid, tightly woven, or loosely knitted woven sheet of autologous, allogeneic, xenogeneic, or artificial material, which may be the same as or different from the valve leaflet material. The skirt material may include polytetrafluoroethylene (PTFE), polyester, or polyethylene terephthalate (PET). In variations including open-pore materials, the average pore size may range from about 0.035 mm to 0.16 mm, or 0.05 mm to 0.10 mm, or 0.07 mm to 0.09 mm. Open-pore materials can provide greater elasticity or flexibility in regions of the stent structure undergoing significant configurational changes. Other regions of the stent may have a solid sheet lacking pores, where elasticity or flexibility is not required. The skirt material may include a single-layer or multi-layer structure and include one or more coatings to modulate thrombus formation, tissue ingrown growth, and / or lubrication.

[0106] Figure 5A and Figure 5B An example of a replacement valve 500 is depicted, having a skirt 502 comprising two different materials attached to a support structure 504. In this particular embodiment, a solid or tightly woven material is disposed as a sleeve structure 506 around the outer and inner surfaces of the downstream or lower region 508 of the outer wall 510. Sleeve structures of the same or different solid or tightly woven materials are disposed on the outer surface of the inner wall 512. Figure 5C A variation of the inner wall 512 using a single material is depicted. Figure 5DAnother variation is depicted, in which the same sleeve structure spans the annular cavity 522 and covers the outer surface of the inner wall 512. A porous knitted material is used for the upper region 516 of the outer wall 510, the transition wall 518, and another sleeve structure 514 around the upstream opening 520 of the inner wall 512 of the scaffold structure 504. Artificial or animal-derived materials may be used to form the valve pockets and valve leaflets 516a-c located within the lumen 512. In addition to providing elasticity to expand with the expansion of the scaffold structure, the porous knitted material also provides for cell migration and inward tissue growth to replace the valve. This dual-material skirt 502 allows blood flowing into the annular cavity 522 to pass through the porous material of the sleeve structure 514, but the porous material may be configured with a sufficiently small porosity to resist the passage of any thrombi that may have formed.

[0107] In such Figures 6A to 6D In another depicted variant, the skirt 600 comprises a tubular material. The shaped skirt 600 provides a more consistent attachment to the support structure, with fewer potential problems of excess sheet material in narrower support regions. In this particular variant, the skirt 600 includes an internal central cavity 602 formed by an inner wall 604 and an internal annular cavity 606 between the inner wall 604 and the shaped outer wall 608. The outer wall 608 may be shaped to complement the outer wall of the support structure, such as an expanded upstream region 610, a reduced-diameter intermediate region 612, and an increased-diameter downstream region 614. The skirt 600 is positioned on the closed end of the support structure such that the support structure is located within the annular cavity 606, and the inner wall 604 of the skirt 600 is positioned within the inner cavity of the support structure. In some variants, the inner wall 604 may be turned inward into the inner cavity of the support 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 600 may comprise a porous or knitted material that can be heat-set into an expanded configuration and spans the entire outer wall 608, the transition wall 618 of the skirt 600, and optionally a portion of the inner wall 604, where it is stitched, bonded, and / or welded to a tubular, tightly woven material configured to line the cavity of the support structure. A tapered annular skirt 616 may also be stitched, bonded, welded, or otherwise attached to the inner surface of the outer wall 608 and the outer surface of the inner wall 604 after initial assembly of the outer wall 608 and inner wall 604 with the support structure. Similarly, a valve leaflet structure may be stitched, bonded, welded, or otherwise attached to the inner wall 604 of the skirt 600 after the inner wall 604 is inserted into the cavity of the support structure.

[0108] The skirt material can be sewn against the inner wall, transition wall and / or outer surface and / or inner surface of the stent, and in some variations it can be set as a sleeve or fold structure on the outer end, inner end or transition wall of the stent structure to span the inner and outer surfaces of the stent wall, or transition from the inner or outer surface of one wall to another, for example, lining the annular cavity of the replacement valve to cover the inner surface of the outer wall, the inner surface of the transition wall and the outer surface of the inner wall.

[0109] Figure 15 Another exemplary embodiment of the replacement valve 1500 is depicted, which includes a support frame 1502 and a valve assembly 1504. For clarity, valve leaflets are omitted in the figures, and only the inner skirt 1506 and outer skirt 1508 of the valve assembly 1504 are depicted. In this embodiment, the inner skirt 1506 lining the inner wall 1510 and / or the outer skirt 1508 covering the outer surface of the outer wall 1512 comprises a polymer material as disclosed above and may be a knitted or woven fabric comprising PET or a PET / ultra-high molecular weight polyethylene blend. In some variations, woven materials may be used when reduced porosity or sealing material is desired, while knitted materials may be used when greater porosity or inward tissue growth is desired. In the specific embodiment depicted, the inner skirt 1506 also includes one or more cuts or openings 1514 located between the valve commissures. It is presumed that the retrograde blood flow into the open end of valve 1500 can fill the annular cavity 1516 between the inner and outer walls 1510, 1512 of valve 1500, and then be guided toward the valve leaflets (not shown) via the skirt opening 1514. This increased flow toward the valve leaflets can improve the force and velocity of valve closure, which can improve leaflet kinematics and valve hemodynamics. This particular embodiment is also depicted with exemplary embedded barbs 1518 and eyelets 1520, 1522 as elsewhere herein, although for simplicity, eyelets 1520, 1522 are depicted without any annulus.

[0110] Figure 7A and Figure 7B This is a photograph of an exemplary replacement valve 700, which has the features described above. Figure 5A and Figure 5B The dual-material skirt, used for mitral valve animal research, was removed after 30 days. Figure 7A On the atrial side of the valve 700, tissue or cell inward growth was observed in the macroporous knitted fabric 702, as well as good inward growth at the boundary or junction between the macroporous knitted fabric 702 and the tightly woven fabric, while good tissue ingrowth was noted on the ventricular side of the valve 700 (mainly covered by the microporous tightly woven fabric 704 surrounding the external and internal openings 706, 708).

[0111] Figure 16A and Figure 16BAn exemplary embodiment of a support structure or frame 1600 in an expanded configuration is depicted. Although not shown, the support structure 1600 may collapse into a collapsed configuration. In some embodiments, the support structure 1600 may self-expand when unconstrained. Figure 16A A perspective view of the support structure 1600 is shown. Figure 16B A cross-sectional view of the support structure 1600 is shown.

[0112] The support structure 1600 includes an inner cavity 1602 formed by an inner wall 1604. An outer wall 1606 is radially spaced from the inner wall 1604 via a transition wall 1608, forming an annular cavity 1610. The inner wall 1604 and the outer wall 1606 form a folded double wall. The transition wall 1608 can be created by folding, inward, or outward from a single tubular structure to form a double-walled integral tubular support frame or structure. In the illustrated embodiment, the transition wall 1608 can extend radially outward. The support structure 1600 has a first closed end 1612 located at the transition wall 1608 and a second open end 1614 at the outer wall 1606, wherein the annular cavity 1610 is open and accessible. The first closed end 1612 tapers due to the angle 1628 of the transition wall 1608.

[0113] The inner cavity 1602 includes a first opening 1616 surrounded by a transition wall 1608 and a second opening 1618 located at the second open end 1614 of the support structure 1600. In the illustrated embodiment, the longitudinal axis 1620 of the inner cavity 1602 coincides with the central axis of the support structure 1600. In some embodiments, the inner cavity 1602 may be eccentrically positioned relative to the outer wall 1606 of the support structure 1600. Figure 16A and Figure 16B As shown, the cavity 1602 typically includes a circular cross-sectional shape and has a generally cylindrical shape between the first opening 1616 and the second opening 1618. In other examples, the cavity 1602 may include a truncated conical, elliptical, or polygonal shape. In some variations, the support structure may include a cavity in which the first and second openings may have different sizes and / or shapes. In embodiments where the cavity includes a non-cylindrical shape...

[0114] The positions of the first opening 1616 and the second opening 1618 of the inner cavity 1602 relative to the entire support structure 1600 can also vary. In the illustrated embodiment, as... Figure 16A and Figure 16BAs shown, the first opening 1616 of the inner cavity 1602 is recessed relative to the first closed end 1612. As the first closed end 1612 tapers, the first opening 1616 also tapers as it extends away from the inner wall 1604. In other examples, the first opening 1616 may be approximately flush with the transition wall 1608 of the support structure 1600. The position of the first opening 1616 can also be characterized as being recessed, flush, or protruding relative to the longitudinal position of the inner joint 1622 between the inner wall 1604 or the inner cavity 1602 and the transition wall 1608, or relative to the longitudinal position of the outer joint 1624 between the transition wall 1608 and the outer wall 1606, such as... Figure 16B As shown. Similarly, the second opening 1618 of the lumen 1602 can also be characterized as recessed, flush, or protruding relative to the longitudinal position of the outer opening 1626 of the outer wall 1606. For example, for the stent structure 1600, the second opening 1618 of the lumen 1602 includes an offset or protruding position relative to the outer opening 1626 of the outer wall 1606. In some variations, where a smaller or shorter outer wall 1606 is preferred to accommodate a smaller-sized native valve anatomy, the lumen 1602 may protrude relative to the second opening 1614 of the outer wall 1606. However, the size of the lumen 1602 can remain relatively consistent across different size variations to provide consistent valve geometry and / or hemodynamic characteristics.

[0115] As discussed above, the transition wall 1608 of the support structure 1600 typically extends radially outward at a predetermined angle 1628 and surrounds the inner cavity 1602 in an expanded configuration, but may have different shapes and / or surface angles in other variations. In the illustrated embodiment, the transition wall 1608 also includes a curved shape, such as a concave or convex shape. In other variations, the transition wall 1608 may have a generally orthogonal angle relative to the longitudinal axis of the inner cavity 1602. Referring again... Figure 16B The transition wall 1608 of the support structure 1600 can form an external acute angle 1628 relative to the longitudinal axis 1620 of the inner cavity 1602. The angle 1628 can be within the range of +45 to +89 degrees, +75 to +89 degrees, or +81 to +85 degrees, with selectable variations within the range of ±1 degree, ±2 degrees, ±3 degrees, or ±4 degrees. In other variations, the transition wall angle can be within the range of -45 to +45 degrees, -75 to +75 degrees, or -85 to +85 degrees.

[0116] The stent structure 1600 includes a plurality of integrally formed stent struts, such as longitudinal struts 1630, 1632 and transverse struts 1634, 1636, 1638, 1639. The inner wall 1604 may include longitudinal struts 1630 along the lumen 1602 of the stent structure 1600, the longitudinal struts 1630 having a linear configuration such that they are generally parallel to each other in their expansion and contraction configurations. Due to this arrangement, the lumen 1602 does not exhibit any shortening when changing from a contraction configuration to an expansion configuration. This reduces or eliminates any axial stretching of the valve structures attached to the lumen. This also allows the lumen 1602 to be predictably positioned and deployed while reducing the risk of unintended displacement.

[0117] The outer wall 1606 may include longitudinal struts 1632 extending from a first closed end 1612 of the outer wall 1606 to a second open end 1614.

[0118] The transition wall 1608 of the support structure 1600 transitions from the longitudinal support 1630 of the inner wall 1604 to the longitudinal support 1632 of the outer wall 1606. For example... Figure 16B As shown, the transition wall 1608 can bend back from the longitudinal support 1630 of the inner wall 1604 to the longitudinal support 1632 of the outer wall 1606.

[0119] As previously stated, in some embodiments, the outer wall 1606 of the support structure 1600 includes a non-cylindrical shape when in an expanded configuration. The outer wall 1606 may include a first end region 1640 (including an externally convex shape) continuous with the transition wall 1608 and a second end region 1642 forming an external opening 1626. The shape and curvature of the outer wall 1606 may be related to... Figure 1G The parameters of the support structure 100 discussed and illustrated are similar to or fall within those parameters. For example, the outer wall 1606 may include a first end region 1640 continuous with the transition wall 1608. The outer wall 1606 may include a plurality of longitudinal struts 1632, each longitudinal strut including a compound curve. Figure 16B In the illustrated embodiment, each longitudinal strut 1630 transitions from a concave curve at the first closed end 1612 to a convex curve, and then to a concave curve at the second open end 1614. Each curve may have a different radius of curvature to form a composite curve of the outer wall 1606. In some variations, the support frame geometry may be characterized by the relative curvature of the longitudinal struts. The maximum curvature may be the concave curve R6 (relative to the annular cavity 1610) adjacent to the outer joint 1624, which is greater than the convex curve R7 at the intermediate region 1641, which is further greater than the concave curve R8 located in the first end region 1640 region of the outer wall 1606, followed by the concave curve R9 at the inner joint 1622, and then the concave curvature R of the second end region 1642. 10 Then there is the slight concave curvature R of the transition wall 1608. 11 .

[0120] While the non-cylindrical configuration of the outer wall 1606 may exhibit some shortening as it transitions from a relatively straight orientation in its contraction configuration to an hourglass shape or concave / convex / concave profile in its expansion configuration, the shortening effect may be uneven or asymmetrical, potentially altering the relative positions of certain features of the outer wall 1606. This can be mitigated by adjusting the angular orientation of the transition wall 1608, which can then shift the outer wall 1606 toward or away from the inlet opening 1616 of the stent structure 1600 and counteract some other longitudinal displacement of the outer wall 1606 due to shortening. This, for example, allows the reduced-diameter intermediate segment of the outer wall 1606 to maintain approximately the same relative longitudinal position relative to the entire length of the stent or relative to the valve position within the stent before and after expansion. This, in turn, can help maintain the intended implantation position during delivery.

[0121] The transverse struts 1634 of the inner wall 1604 can be characterized by a set of continuous transverse struts forming partial or complete circumferential or perimeter struts around the inner wall 1604 of the support structure 1600. However, the transverse struts 1634 can vary not only in their circumferential orientation. To facilitate the expansion and contraction of the entire support structure, one or more, or all, of the transverse struts may include a pair of angled legs 1634a, 1634b, wherein each lateral end of each angled leg is continuous or integrally formed with the longitudinal strut 1630, and wherein each angled leg joins together at a central tapering 1634c. The pair of angled legs 1634a, 1634b may be angled toward either the first closed end 1612 or the second open end 1614. The structure of the pair of angled legs 1634a, 1634b may be similar to that described above. Figures 4A-4C The horizontal supports discussed are similar.

[0122] The transverse struts 1636 in the second end region 1642 of the outer wall 1606 can also be characterized by a set of continuous transverse struts forming partial or complete circumferential or perimeter struts around the outer wall 1606 of the support structure 1600. However, the transverse struts 1636 can vary not only in their circumferential orientation. To facilitate the expansion and contraction of the entire support structure, one or more, or all, of the transverse struts may include a pair of angled legs 1636a, 1636b, wherein each lateral end of each angled leg is continuous or integrally formed with the longitudinal strut 1632, and wherein each angled leg joins together at a central taper 1636c. While the curved configuration formed by the two angled legs may include a simple bend, in other examples, each leg 1636a, 1636b may extend centrally to form a hairpin bend region 1636d. The structure of the pair of angled legs 1636a, 1636b may be similar to that described above. Figures 4A-4C The horizontal supports discussed are similar.

[0123] In the illustrated embodiment, the transverse struts 1638 in the intermediate region 1641 may project radially outward relative to the outer wall 1606. For example, in the intermediate region 1641 of the outer wall 1606, a pair of angled legs 1638a, 1638b project radially outward and are configured to act as barbs or anchors. Figure 16A and Figure 16B As shown, the orientation of the legs 1638a, 1638b and the intermediate bend 1638c of one or more sets of circumferential struts 1638 may also be radially outward relative to the adjacent longitudinal struts 1632 to provide barbed or force-concentrating structures to resist displacement of the strut structure relative to the native valve tissue.

[0124] In the illustrated embodiment, the transverse struts 1639 in the first end region 1640 may project radially outward relative to the outer wall 1606. For example, in the first end region 1640 of the outer wall 1606, a pair of angled legs 1639a, 1639b project radially outward and are configured to act as barbs or anchors. Figure 16A and Figure 16B As shown, the orientation of the legs 1639a, 1639b and the intermediate bend 1639c of one or more sets of circumferential struts 1639 may also be radially outward relative to the adjacent longitudinal struts 1632 to provide barbed or force-concentrating structures, thereby resisting displacement of the strut structure relative to the native valve tissue.

[0125] like Figure 16A As shown, the support structure 1600 may also include a plurality of longitudinal barbs 1654, which may optionally be adapted to any support frame embodiment herein. The barbs 1654 are located within the elongated cavities or openings 1656 of the longitudinal struts 1632. Structural details of the barbs 1654 may be found in relation to... Figure 11A-Figure 11 The longitudinal barbs discussed in B are similar to 1114. Figure 16A and Figure 16B The exemplary embodiment depicted is located at one end of the longitudinal strut 1632, at the junction between the two transverse struts 1636, but in other variations, the barb 1654 may be located along the longitudinal strut 1632 at a junction spaced apart from the end of the longitudinal strut 1632, or at a location away from the junction where the transverse struts 1636 are located.

[0126] Figure 17A and Figure 17B An exemplary embodiment of a support structure or frame 1700 in an expanded configuration is shown. Although not shown, the support structure 1700 may collapse into a collapsed configuration. In some embodiments, the support structure 1700 may self-expand when unconstrained. Figure 17A A perspective view of the support structure 1700 is shown. Figure 17BA cross-sectional view of the support structure 1700 is shown. The support structure 1700 may have similar features to the support structure 1600, which will not be repeated below.

[0127] The support structure 1700 includes an inner cavity 1702 formed by an inner wall 1704. An outer wall 1706 is radially spaced from the inner wall 1704 via a transition wall 1708, forming an annular cavity 1710. The transition wall 1708 can be created by folding, inward, or outward from a single tubular structure to form a double-walled integral tubular support frame or structure. The support structure 1700 has a first closed end 1712 located at the transition wall 1708 and a second open end 1714 at the outer wall 1706, wherein the annular cavity 1710 is open and accessible.

[0128] The inner cavity 1702 includes a first opening 1716 surrounded by a transition wall 1708 and a second opening 1718 located at the second open end 1714 of the support structure 1700. In the illustrated embodiment, the longitudinal axis 1720 of the inner cavity 1702 coincides with the central axis of the support structure 1700. In some embodiments, the inner cavity 1702 may be eccentrically positioned relative to the outer wall 1706 of the support structure 1700. Figure 17A and Figure 17B As shown, the cavity 1702 typically comprises a circular cross-sectional shape and has a generally cylindrical shape between the first opening 1716 and the second opening 1718. In other examples, the cavity 1702 may comprise a truncated conical, elliptical, or polygonal shape. In some variations, the support structure may comprise a cavity in which the dimensions and / or shapes of the first and second openings may differ. In embodiments where the cavity comprises a non-cylindrical shape, some shortening of the inner wall may occur.

[0129] The stent structure 1700 includes a plurality of integrally formed stent struts, such as longitudinal struts 1730, 1732 and transverse struts 1734, 1736. The inner wall 1704 may include longitudinal struts 1730 along the lumen 1702 of the stent structure 1700, having a linear configuration such that the longitudinal struts 1730 are generally parallel to each other in their expansion and contraction configurations. Due to this arrangement, the lumen 1702 does not exhibit any shortening when changing from a contraction configuration to an expansion configuration. This reduces or eliminates any axial stretching of the valve structures attached to the lumen. This also allows the lumen 1702 to be predictably positioned and deployed while reducing the risk of unintended displacement.

[0130] The outer wall 1706 may include a longitudinal strut 1732 extending from a first closed end 1712 of the outer wall 1706 to a second open end 1714.

[0131] The transition wall 1708 of the support structure 1700 transitions from the longitudinal support 1730 of the inner wall 1704 to the longitudinal support 1732 of the outer wall 1706. The transition wall 1708 can bend back from the longitudinal support 1730 of the inner wall 1704 to the longitudinal support 1732 of the outer wall 1706. In some embodiments, such as Figure 17B As shown, transition wall 1708 bends back approximately 180 degrees.

[0132] The outer wall 1706 of the support structure 1700, in its expanded configuration, includes a non-cylindrical shape. The outer wall 1706 of the support structure 1700 may include a first end region 1740, a middle portion 1741, and a second end portion 1742. The first end region 1740 of the outer wall 1706 may be continuous with a transition wall 1708. The outer wall 1706 may include longitudinal struts 1730 incorporating compound curves. Figure 17B In the illustrated embodiment, the longitudinal strut 1730 includes a straight segment 1703 having a free, straight inner end 1705 along the inner wall 1704, which transitions to a concave curve at a first closed end 1712 (relative to the annular cavity 1710 formed between the inner wall 1704 and the outer wall 1706), then to a convex curve 1707, then to a concave curve 1709, then to a convex curve 1711, then to a concave curve 1713, and terminates at a free-bending outer end 1715 around the second open end 1714 of the implant 1700. Each of these segments of the longitudinal strut 1730 lies in the same radial plane, and each curve may have a different radius of curvature to form a composite curve of the outer wall 1706. (Refer to...) Figure 17A Furthermore, the first end region 1740 and the second end portion 1742 of the outer wall 1706 also include transverse struts 1736 and 1738, wherein the transverse strut 1736 of the second end region 1742 has a generally convex curve profile (relative to the annular cavity 1710), while the transverse strut 1738 of the first end region 1740 has a generally convex shape (relative to the annular cavity 1710). In some variations, the relative degree of curvature is the concave curve (R) of the first closed end 1712. 12 The maximum value is at point 1741, followed by the convex curve 1711 (R) in the middle segment. 13 ), R 13 Furthermore, the concave curvature of the first end region 1740 is greater than that of 1709 (R). 14 The curvature of R 14 The convex curve 1707 (R) is larger than the first end portion 1740. 15 ), the concave curve of the transverse support 1738 (R) 16 ), the convex curve of the transverse support 1736 or the concave curve of the second end portion 1742 of the outer wall 1706 (R) 17 The slight curvature set in ).

[0133] While the non-cylindrical configuration of the outer wall 1706 may exhibit some shortening as it transitions from a relatively straight orientation in its contracting configuration to an hourglass shape or concave / convex / concave / convex / concave profile in its expanding configuration, the shortening effect may be uneven or asymmetrical, thus altering the relative positions of certain features of the outer wall 1706. This can be mitigated by adjusting the angular orientation of the transition wall 1708, which can shift the outer wall 1706 toward or away from the inlet opening 1716 of the scaffold structure 1700 and counteract the longitudinal displacement of the outer wall 1706 due to shortening. This, for example, allows the reduced-diameter intermediate segment of the outer wall 1706 to maintain approximately its relative longitudinal position relative to the scaffold before and after expansion. This, in turn, can help maintain the intended implantation position during delivery.

[0134] The transverse struts 1734 of the inner wall 1704 can be characterized by a set of continuous transverse struts forming partial or complete circumferential or perimeter struts around the inner wall 1704 of the support structure 1700. However, the transverse struts 1734 can vary not only in their circumferential orientation. To facilitate the expansion and contraction of the entire support structure, one or more, or all, of the transverse struts may include a pair of angled legs 1734a, 1734b, wherein each lateral end of each angled leg is continuous or integrally formed with the longitudinal strut 1730, and wherein each angled leg joins together at a central tapering 1734c. The pair of angled legs 1734a, 1734b may be angled toward either the first closed end 1712 or the second open end 1714. The structure of the pair of angled legs 1734a, 1734b may be similar to that described above. Figures 4A-4C The horizontal supports discussed are similar.

[0135] The transverse struts 1736 of the outer wall 1706 can also be characterized by a set of continuous transverse struts forming partial or complete circumferential or perimeter struts around the outer wall 1706 of the support structure 1700. However, the transverse struts 1736 are not only variable in their circumferential orientation. To facilitate the expansion and contraction of the entire support structure 1700, one or more, or all, of the transverse struts 1736 may include a pair of angled legs 1736a, 1736b, wherein each lateral end of each angled leg 1736a, 1736b is continuous or integrally formed with the longitudinal strut 1732, and wherein each angled leg 1736a, 1736b joins together at a central taper 1736c. While the curved configuration formed by the two angled legs 1736a, 1736b may include a simple bend, in other examples, each leg 1736a, 1736b may extend centrally to form a hairpin bend region 1736d. The structure of the pair of angled legs 1736a and 1736b is similar to that described above. Figures 4A-4C The horizontal supports discussed are similar.

[0136] In the illustrated embodiment, the transverse support 1738 in the first end region 1740 may project radially outward relative to the outer wall 1706 to form a plurality of lateral protrusions. The plurality of lateral protrusions may extend circumferentially around the outer wall of the support structure 1700. For example, in the first end region 1740 of the outer wall 1706, a pair of angled legs 1738a, 1738b connected at a central bend 1738c at the apex project radially outward and are configured to act as barbs or anchors. Figure 17B As shown, the orientation of the angled legs 1738a, 1738b and intermediate bend 1738c of one or more sets of circumferential struts 1738 may also be radially outward relative to the adjacent longitudinal struts 1732 to provide barbed or force-concentrating structures, thereby resisting displacement of the strut structure relative to the native valve tissue. A pair of angled legs 1738a, 1738b includes a composite curve with an inflection point that transitions the concave curve at the junction of the pair of angled legs 1738a, 1738b and the longitudinal strut 1732 to a convex curve.

[0137] like Figure 17A As depicted, the support structure 1700 may also include a plurality of longitudinal barbs 1754, which may optionally be adapted to any support frame embodiment herein. The barbs 1754 are located within the elongated cavities or openings 1756 of the longitudinal struts 1732. Structural details of the barbs 1754 may be found in relation to... Figure 11A-Figure 11 The longitudinal barbs discussed in B are similar to 1114. Figure 17A and Figure 17B The exemplary embodiment depicted is located at one end of the longitudinal strut 1732, at the junction between the two transverse struts 1736, but in other variations, the barb 1754 may be located along the longitudinal strut 1732 at a junction spaced apart from the end of the longitudinal strut 1732, or at a location spaced apart from the junction where the transverse struts 1736 are located.

[0138] Figures 18A-18B The skirt 1800 used for the support structure is shown. Figure 18A A perspective view of the skirt section 180° is shown. Figure 18B A side view of the skirt 1800 is shown. In some embodiments, the skirt 1800 is configured to conform to the shape of the support structure and / or pre-formed into an hourglass shape to facilitate the skirt 1800 conforming to the support structure, for example... Figure 11C and Figures 16A-17BThe support structures 1120, 1600, and 1700 are included. A skirt 1800 is configured to be fixed to the outer wall of the support structure, thus the skirt can have a shape similar to the outer wall of the support structure. The skirt 1800 includes an upper portion 1802, a middle portion 1804, and a lower portion 1806. The upper portion 1802 includes a first diameter, the middle portion 1804 includes a second diameter, and the lower portion 1806 includes a third diameter. The first and third diameters are larger than the second diameter, and the first diameter can be similar to the third diameter. Therefore, the skirt 1800 has an hourglass shape.

[0139] The lower portion 1806 of the skirt 1800 includes a plurality of slits 1810 disposed along the lower edge 1808 of the skirt 1800. The plurality of slits 1810 are disposed between extensions 1809 such that the lower edge 1808 alternates between extensions 1809 and slits 1810. In some embodiments, the extensions 1809 may be aligned with longitudinal supports of the support structure, similar to the description above. Figures 16A-17B The longitudinal struts 1630 and 1730 of the scaffold structures 1600 and 1700 discussed. Extension 1809 can provide additional suture or attachment surface area between the skirt 1800 and the longitudinal struts, and may include elongated shapes, such as rectangular or sheet-like shapes. It may also accommodate any tissue-engaging barbs (such as...) provided on the scaffold structure. Figures 11A to 11C The depicted barbs are provided with pre-formed holes or grooves 1816. Due to the longitudinal orientation of the barbs, the holes or grooves may have a vertical or longitudinal orientation or shape.

[0140] Multiple cutouts 1810 may include vertical edges 1812 connected by concave curves 1814. Concave curves 1824 may follow the transverse supports of the outer wall of the support structure, similar to those described above. Figures 16A-17B The lateral struts 1634 and 1734 of the stent structures 1600 and 1700 discussed. Among other benefits, the multiple incisions 1810 of the skirt 1800 improve the volumetric efficiency of the replacement valve and reduce sheath load. Figure 18A and Figure 18B The exemplary skirt / cover 1800 can be adapted for use with support structures 100, 150, 1600, 1700.

[0141] Figures 19A-19C The replacement valve 1900 is shown, which includes a stent frame 1910 and a valve assembly 1920. Figure 19AA perspective view of a replacement valve 1900 is shown, wherein a valve assembly 1920 is attached to a stent frame 1910. The valve assembly 1920 includes a plurality of leaflets 1922a-c located within a cavity 1912 of the stent frame 1910. The illustrated embodiment includes three leaflets 1922a-c; however, this disclosure is not limited thereto. The valve assembly 1922 may include more or fewer than three leaflets 1922a-c. The plurality of leaflets 1922a-c may be formed of artificial or animal-derived materials. The valve assembly 1920 also includes valve commissures 1924a-c, with the leaflets 1922a-c abutting at the commissure within the cavity 1912 of the stent frame 1910. The replacement valve 1900 may also include an inner skirt liner 1930 and an outer skirt liner (not shown). The outer skirt liner may be associated with... Figures 18A-18B The skirt is similar to the one in 1800.

[0142] The valve assembly 1920 can be attached to the stent frame 1910 using multiple brackets 1940. The number of brackets 1940 corresponds to the number of leaflets 1922a-c of the valve assembly 1920. Figure 19A In the illustrated embodiment, the replacement valve 1900 includes three brackets 1940, which correspond to the three leaflets 1922a-c of the valve assembly 1920.

[0143] Figure 19B A detailed perspective view of the replacement valve 1900 is shown, in which the valve assembly 1920 is attached to a support frame 1910 by a bracket 1940, wherein one of the brackets 1940 attaches a first leaflet 1922a and a second leaflet 1922b to the bracket 1940 and the support frame 1910. In the illustrated embodiment, the bracket 1940 is U-shaped, having a first arm 1942 and a second arm 1944, and a connecting portion 1946 for attaching the first arm 1942 and the second arm 1944. The bracket 1940 also includes an opening 1943 between the first arm 1942 and the second arm 1944. The bracket 1940 also includes a plurality of holes 1948 on the first arm 1942 and the second arm 1944. The support frame 1910 also includes a plurality of holes 1914 disposed along a longitudinal strut 1916.

[0144] Leaflets 1922a-b and connecting portion 1924a extend on the inner surface of bracket 1940 through opening 1943 of bracket 1940. Leaflet 1922a wraps around bracket 1940 to the outer surface of first arm 1942, and leaflet 1922b wraps around bracket 1940 to the outer surface of second arm 1944. A suture 1949 is used to connect leaflets 1922a-b and connecting portion 1924a to support frame 1910. The suture 1949 extends through hole 1914 in support frame 1910, hole 1948 in first arm 1942 and second arm 1944, and leaflets 1922a-b. In the illustrated embodiment, two adjacent sutures 1949 are used for illustration. Figure 19B The suture path is indicated by arrows (two arrows for each suture 1949). Each suture 1949 passes through the hole 1914 (bottom arrow) of the longitudinal strut 1916 toward the valve assembly 1920, enters one of the everted connecting wings 1922d of the leaflet 1922b, and enters the hole 1948 of the first arm 1944 of the bracket 1940, enters the gap or opening 1943 between the arms 1942 and 1944 of the bracket 1940, passes through the fitting leaflets 1922a and 1922b located in the opening 1943, exits through the opening 1948 on the other arm 1942 of the bracket 1940, and exits through the everted wing 1922c of the other leaflet 1922a, as shown. Figure 19C As shown. Then the suture 1949 loops back through the same hole 1914 of the longitudinal support 1916, and is then guided to the next adjacent hole 1914 of the support 1916, passing again through the flared flaps of leaflets 1922a and 1922b, the bracket hole 1948, and the fitting leaflets 1922a and 199b, and then back through the adjacent hole 1914 (second arrow from the bottom). Another suture 1949 takes a similar arrangement, passing through the next two adjacent holes, through the fitting leaflets 1922a and 1922, through the two inner layers of leaflets 1922a and 1922b between the arms 1942 and 1944 of the bracket 1940, through the fitting leaflets 1922a and 1922b located in the opening 1943, through the opening 1948 on the other arm 1942 of the bracket 1940, and through the flared flap 1922c of another leaflet 1922a.

[0145] Figure 19C A cross-sectional view is shown showing the leaflets 1922a-b and the connecting portion 1924a connected to the bracket 1940 by suture 1949. For ease of explanation, Figure 19C The support frame 1910 is not shown. The suture 1949 extends through one layer of leaflet 1922a, then through the hole 1948 of the first arm 1942, then through another layer of leaflet 1922a, then through one layer of leaflet 1922b, then through the hole 1948 of the second arm 1944, and then through another layer of leaflet 1922b.

[0146] Figure 20A and Figure 20B A replacement valve 2000 is shown, which includes a support frame 2010 and a valve assembly 2020, including another embodiment that attaches the leaflets to a bracket 2040. The replacement valve 2000 may include, with respect to Figure 19A All structural components discussed in the replacement valve 1900.

[0147] Figure 20AA detailed perspective view of the replacement valve 2000 is shown, in which the valve assembly 2020 is attached to the stent frame 2010 via a bracket 2040. The bracket 2040 attaches a first leaflet 2022a and a second leaflet 2022b to both the bracket 2040 and the stent frame 2010. The bracket 2040 and... Figures 19A-19C Similar to bracket 1940. Bracket 2040 is U-shaped, having a first arm 2042 and a second arm 2044, and a connecting portion 2046 for attaching the first arm 2042 and the second arm 2044. Bracket 2040 also includes an opening 2043 between the first arm 2042 and the second arm 2044. Bracket 2040 also includes a plurality of holes 2048 on the first arm 2042 and the second arm 2044. Support frame 2010 also includes a plurality of holes 2014 disposed along longitudinal support post 2016.

[0148] Leaflets 2022a-b and connecting portion 2024a extend entirely through opening 2043 of bracket 2040. Leaflets 2022a-b then fold back, forming two layers of each leaflet 2022a-b, and respectively join the inner surfaces of the first arm 2042 and the second arm 2044 of bracket 2040. Leaflet 2022a wraps around bracket 2040 to the outer surface of the first arm 2042, and leaflet 2022b wraps around bracket 2040 to the outer surface of the second arm 2044. A suture 2049 is used to connect leaflets 2022a-b and connecting portion 2024a to support frame 2010. The suture 2049 extends through hole 2014 in support frame 2010, hole 2048 in first arm 2042 and second arm 2044, and leaflets 2022a-b. In the illustrated embodiment, two sutures 2049 can be used, which can follow... Figure 20A The path indicated by the middle arrow.

[0149] Figure 20B A cross-sectional view is shown showing the leaflets 2022a-b and the connecting portion 2024a connected to the bracket 2040 by suture 2049. For ease of explanation, Figure 20B The support frame 2010 is not shown. The suture 2049 extends through one layer of leaflet 2022a, then through the hole 2048 of the first arm 2042, then through two layers of leaflet 2022a inside the opening 2043, then through two layers of leaflet 2022b inside the opening 2143, then through the hole 2048 of the second arm 2044, and then through another layer of leaflet 2022b.

[0150] Figure 21A and Figure 21B The replacement valve 2100 is shown, which includes a support frame 2110 and a valve assembly 2120, including another embodiment that attaches the leaflets to a bracket 2140. The replacement valve 2100 may include all the structural components discussed with respect to the replacement valve 1900 of FIG. 19.

[0151] Figure 21A A detailed perspective view of the replacement valve 2100 is shown, in which the valve assembly 2120 is attached to the stent frame 2110 via a bracket 2140. The bracket 2140 attaches the first leaflet 2122a and the second leaflet 2122b to both the bracket 2140 and the stent frame 2110. The bracket 2140 and... Figures 19A-19C Similar to bracket 1940. Bracket 2140 is U-shaped, having a first arm 2142 and a second arm 2144, and a connecting portion 2146 for attaching the first arm 2142 and the second arm 2144. Bracket 2140 also includes an opening 2143 between the first arm 2142 and the second arm 2144. Bracket 2140 also includes a plurality of holes 2148 on the first arm 2142 and the second arm 2144. Support frame 2110 also includes a plurality of holes 2114 disposed along longitudinal support post 2116.

[0152] Leaflets 2122a-b and connecting portion 2124a extend across the opening 2143 of the bracket 2140 on the inner surface of the bracket 2140. Leaflet 2122a wraps around the bracket 2140 to the outer surface of the first arm 2142 and folds back to form two layers of leaflet 2122a. Leaflet 2122b wraps around the bracket 2140 to the outer surface of the second arm 2144 and folds back to form two layers of leaflet 2122b. A suture 2149 is used to connect leaflets 2122a-b and connecting portion 2124a to the support frame 2110. The suture 2149 extends through the hole 2114 of the support frame 2110, the hole 2148 of the first arm 2142 and the second arm 2144, and the leaflets 2122a-b. In the illustrated embodiment, two sutures 2149 can be used, which can follow... Figure 21B The path indicated by the middle arrow.

[0153] Figure 21B A cross-sectional view is shown showing the leaflets 2122a-b and the connecting portion 2124a connected to the bracket 2140 by suture 2149. For ease of explanation, Figure 21B The support frame 2110 is not shown. The suture 2149 extends through two layers of leaflets 2122a, then through the hole in the first arm 2142, then through another layer of leaflets 2122a inside the opening 2143, then through one layer of leaflets 2122b inside the opening 2143, then through the hole in the second arm 2144, and then through two layers of leaflets 2122b.

[0154] Figures 22A-22DA replacement valve 2200 is shown, comprising a support frame 2210, a valve assembly 2220, a skirt 2230, and a plurality of ring structures 2240 coupled to the support frame 2210 to aid in the collapse and expansion of the replacement valve 2200. A first set 2250 of the plurality of ring structures 2240 is coupled to a first end region 2212 of the support frame 2210. A second set 2260 of the plurality of ring structures 2240 may be coupled to a second end region 2214 of the support frame 2210. A first suture 2202 may extend through a ring 2242 or loop of each ring 2242 of the first set 2250 of the plurality of ring structures 2240. A second suture 2204 may extend through a ring 2242 of each ring 2242 of the second set 2260 of the plurality of ring structures 2240. Tightening sutures 2202 and 2204 can collapse and constrain the replacement valve 2200, while loosening sutures 2202 and 2204 allows the replacement valve 2200 to expand on its own.

[0155] Figure 22B and Figure 22C A detailed view of one of a plurality of ring structures 2240 is shown. In the illustrated embodiment, the ring structure 2240 includes a ring 2242 and a protrusion 2244 integral with the ring 2242. The ring 2242 is a circular loop with an opening at each end. As described above, the ring 2242 is configured to receive a stitch 2202 or 2204. Figure 22B As shown, ring 2242 can receive more than one suture.

[0156] The protrusion 2244 of the ring structure 2240 includes a pair of holes 2246, which can be used to bind the ring structure 2240 to the support frame 2210. Figure 22C As shown, the support frame 2210 may include a pair of corresponding holes 2216 for binding the ring structure 2240 to the support frame 2210.

[0157] In some implementations, such as Figure 22D As shown, multiple ring structures 2240 can be connected to the atrial side of the stent frame 2210. In other words, the multiple ring structures 2240 are connected to the inner side of the stent frame 2210, rather than as shown in the diagram. Figure 22A It is connected to the outside of the support frame 2210 as shown.

[0158] Figure 23A and Figure 23B A side view of an implant retention / release assembly 2350 of a catheter delivery system is shown. The assembly includes a rotor / stator assembly for maintaining a replacement valve 2300 in a contracted or compressed configuration. A suture 2302 is used to guide the replacement valve 2300. An exemplary suture placement process is described below. Figure 24 and Figure 25 public.

[0159] Figure 24A schematic end view shows a suture placement process for collapsing and replacing the valve 2400 and maintaining the valve 2400 in a collapsed configuration. The valve 2400 may include a plurality of ring structures 2440, which can be connected with respect to... Figures 22A-22D The discussed ring structure 2240 is similar. In the schematic diagram shown, the replacement valve 2400 includes twelve ring structures 2240 evenly spaced around the circumference of the stent frame 2410. The twelve ring structures are positioned at the twelve-hour mark of an analog clock, including a first ring 2441, a second ring 2442, a third ring 2443, a fourth ring 2444, a fifth ring 2445, a sixth ring 2446, a seventh ring 2447, an eighth ring 2448, a ninth ring 2449, a tenth ring 2450, an eleventh ring 2451, and a twelfth ring 2452.

[0160] Figure 24 The stitching process begins with the first segment S1 of thread 2402 tied to the sixth loop 2446. In some embodiments, a slack portion of thread 2402 may be left for the stitching process. In some embodiments, the slack portion of thread 2402 may be six inches. The first segment S1 of thread 2402 passes clockwise through the seventh loop 2447, the eighth loop 2448, and the ninth loop 2449, skips the tenth loop 2450, passes through the eleventh loop 2451, the twelfth loop 2452, and the first loop 2441, and is knotted at the second loop 2442.

[0161] The stitching process continues with the second segment S2 of stitch 2402. The second segment S2 passes clockwise through the third loop 2443, the fourth loop 2444, and the fifth loop 2445, skips the sixth loop 2446, passes clockwise through the seventh loop 2447, the eighth loop 2448, and the ninth loop 2449, and is knotted at the tenth loop 2450.

[0162] The stitching process continues with the third segment S3 of stitch 2402. The third segment S3 passes clockwise through the eleventh loop 2451, the twelfth loop 2452, and the first loop 2441, skips the second loop 2442, and then clockwise through the third loop 2443, the fourth loop 2444, and the fifth loop 2445, before being knotted at the sixth loop 2446. In some embodiments, a slack portion of stitch 2402 may be left after tying to the sixth loop 2446. In some embodiments, the slack portion of stitch 2402 may be six inches.

[0163] The above-described suture placement process can be repeated for the second side (atrial or ventricular side) of the replaced valve 2400. The exemplary tether placement suture configuration described above is based on a stent structure including twelve longitudinal struts, and therefore includes an arrangement of twelve tether loops used with three tethers. However, this arrangement can be extended to stents with other numbers of struts or loops. For example, the relationship between the number of loops and the subset arrangement for the number of tethers X is that for X subsets of loops, the total number of N loops should be divisible by X+1. However, each subset of loops can be configured with any number Y loops. Therefore, in Figure 24 In the depicted implementation, there are N=12 loops, and for each X=3 tethers there are X=3 subsets, each subset comprising Y=3 loops. However, in other variations, the number of tethers can be two, requiring X=2 subsets, and the number of loops or longitudinal supports will need to be a multiple of three (X+1). Therefore, N can be 3, 6, 9, 12, 15, 18, etc., but since the number of subsets is even, available configurations will have 6, 12, or 18 loops, or the number of loops in a subset can be Y=3, Y=6, or Y=9. Figure 25 The configuration in Figure 25 A schematic end view is shown of a suture placement process for collapsing and replacing the valve 2500 and maintaining the valve 2500 in a collapsed configuration. The valve 2500 may include a plurality of ring structures 2540, which can be associated with... Figures 22A-22D The discussed ring structure 2240 is similar. In the schematic diagram shown, the replacement valve 2500 includes twelve ring structures 2540 evenly spaced around the circumference of the stent frame 2510. The twelve ring structures are positioned at the twelve-hour mark of an analog clock and include a first ring 2541, a second ring 2542, a third ring 2543, a fourth ring 2544, a fifth ring 2545, a sixth ring 2546, a seventh ring 2547, an eighth ring 2548, a ninth ring 2549, a tenth ring 2550, an eleventh ring 2551, and a twelfth ring 2552.

[0164] Figure 25 The suture laying process begins with the first segment S1 of suture 2502 tied to the fifth loop 2545. In some embodiments, a slack portion of suture 2502 may be left for the suture laying process. In some embodiments, the slack portion of suture 2502 may be six inches. The first segment S1 of suture 2502 passes clockwise through the sixth loop 2546, the seventh loop 2547, the eighth loop 2548, and the ninth loop 2549, skips the tenth loop 2550, passes counterclockwise from the distal side (as shown) through the eleventh loop 2551, passes counterclockwise through the tenth loop 2550, and is knotted at the ninth loop 2549.

[0165] The stitching process continues with the second segment S2 of stitch 2502. The second segment S2 passes clockwise through the tenth loop 2550, the eleventh loop 2551, the twelfth loop 2552, and the first loop 2541, skips the second loop 2542, and passes counterclockwise from the far side (as shown in the figure) through the third loop 2543, then through the second loop 2542, and is knotted at the first loop 2541.

[0166] The stitching process continues with the third segment S3 of stitch 2502. The third segment S3 passes clockwise through the second loop 2542, third loop 2543, fourth loop 2544, and fifth loop 2545, skips the sixth loop 2546, and passes counterclockwise from the distal side (as shown) through the seventh loop 2547, then counterclockwise through the sixth loop 2546, and is knotted at the fifth loop 2545. In some embodiments, a slack portion of stitch 2502 may be left after tying to the fifth loop 2545. In some embodiments, the slack portion of stitch 2502 may be six inches.

[0167] The above suture placement process can be repeated on the second side (atrial or ventricular side) of the 2500-degree valve replacement. Figure 24Like the shown stent configuration, the above exemplary tether deployment suture configuration is based on a stent structure comprising twelve longitudinal struts, and thus includes an arrangement of twelve tether rings for use with three tethers. However, this arrangement can be generalized to stents with other numbers of struts, rings or tethers, or varying degrees of overlap or ring skipping between or within tethers. For example, in an alternative embodiment, a first suture segment may be attached to a first anchoring ring of the plurality of rings, pass through the first X consecutive rings of the plurality of rings immediately adjacent to the first anchoring ring in a first direction, where X>0, skip Y rings immediately adjacent to the first X consecutive rings in the first direction, pass through Z consecutive rings of the plurality of rings in a second direction, where Z may be 0 or greater than 1 and Z<X, and attach to the next consecutive ring of the plurality of rings in the first direction if Z=0, or attach to the next consecutive ring of the plurality of rings in the second direction if Z>0. The second suture segment is attached to a ring that is the same as the first suture segment and is not the first anchoring ring, passes through the second X consecutive rings of the plurality of rings in the first direction, skips Y rings of the plurality of rings immediately adjacent to the second X consecutive rings in the first direction, passes through Z consecutive rings of the plurality of rings in the second direction, where Z may be 0 or greater than 1 and Z<X, and attaches to the next consecutive ring of the plurality of rings from the second X consecutive rings in the first direction if Z=0, or attaches to the next consecutive ring of the plurality of rings in the second direction if Z>0. The third suture segment is attached to the same ring as the second suture segment (corresponding to the next consecutive ring from the second X consecutive rings in the first direction if Z=0, or the next consecutive ring in the second direction if Z>0), passes through the third X consecutive rings of the plurality of rings, skips Y rings immediately adjacent to the third X consecutive rings in the first direction, passes through Z consecutive rings of the plurality of rings in the second direction, where Z may be 0 or greater than 1 and Z<X, and attaches to the next consecutive ring from the third X consecutive rings in the first direction if Z=0, or attaches to the next consecutive ring in the second direction if Z>0. Within this tether deployment suture framework, various tether configurations can be generated, for example: A) X=3, Y=1 and Z=0.

[0168] B) X=4, Y=1 and Z=2.

[0169] C) X≥2.

[0170] D) X-Z=2.

[0171] In the case of Figure 27In another depicted embodiment, the support 2700 includes a plurality of non-overlapping tethers 2702a-c, wherein the ends 2704a-f of each tether 2702a-c are attached to tether retaining structures or loops 2706d, h, m. Each tether 2702a-c has a nominal coverage length of one-third of the support circumference or a 120-degree arc. Each structure 2706d, h, m is attached by two tethers 2702a-c and is configured with paired or double loops 2706a-b, fg, jk to reinforce the tether loops 2708a-c being pulled out to engage the delivery system. Each tether 2702a-c may also slidably engage other loops 2702c, e, h, j, m, o located between the attached loops 2706d, h, m and the paired loops 2706a-b, fg, jk. The depicted tether configuration is applicable to any circumferential tether configuration location described herein, such as the ends and / or joints of inner walls, outer walls, and / or transition walls or other support pillars. In this specific example, the support 2700 has twelve longitudinal pillars corresponding to the clock hour positions 12 o'clock to 11 o'clock for each single loop or pair of loops 2706a-0. Three separate tethers 2704a-2704c are provided, wherein the first tether 2702a includes ends 2704a, 2704b respectively fixedly attached to loops 2706n and 2706d, slidably engaged to single loops 2706o and 2706c, and engaged to pairs of loops 2706a, 2706b, with a loop 2708a pulled out between them. Similarly, tether 2702b includes ends 2704c and 2704d fixedly attached to rings 2706d and 2706i, and slidably engaged to single rings 2706e and 2706h, and pairs of rings 2706f and 2706g, with loop 2708b pulled out between them. Finally, tether 2702c includes ends 2704e and 2704f fixedly attached to rings 2706i and 2706n, and slidably engaged to single rings 2706j and 2706m, and pairs of rings 2706k and 2706l, with loop 2708c pulled out or engaged between them. In other support structures with different numbers of tethered retaining rings or structures, if the number of tethered lines remains the same, each tether maintains the same relative configuration of the attachment structure and the paired retaining structure, but the individual retaining structure located between the attachment structure and the paired retaining structure will be absent or will include an additional slidable engagement retaining structure. In some further variations, with a greater number of longitudinal supports or tethered retaining structures, an even greater number of tethered lines can be provided to maintain a similar arrangement for each tether.

[0172] Figure 28One embodiment of the tethering configuration of the support 2800 is depicted, comprising a plurality of overlapping tethers 2802a-c, wherein each tether 2802a-c nominally encircles half, for example, 180 degrees, of the circumference of the support 2800. In the overlapping configuration, only the middle third of each tether 2802a-c containing the loops 2808a-c is non-overlapping, while the end third of each tether 2802a-c overlaps with the adjacent tether 2802a-c. Figure 27 Compared to the tether configuration (where each loop fixedly attached to a tether is attached by two tethers), in Figure 28In the depicted embodiment, the ends 2804a-f of the tethers 2802a-c are fixedly attached to the tether holding structure or loops 2806m, e, c, j, h, o, respectively. They are not fixedly attached to other tethers 2802a-c, but are slidably passed through or engaged by adjacent tethers 2802a-c due to the overlapping configuration. Paired loops or double loops 2806a-b, fg, jk are still provided to reinforce the position where the tether loops 2808a-c are pulled out to engage the delivery system. Each of the paired loops 2806a-b, fg, jk is slidably engaged by only one tether 2802a-c, but loops 2806d, i, n are each slidably engaged by two overlapping tethers 2802a-c. The depicted tether configuration can be applied to any circumferential tether configuration location herein, such as the ends and / or joints of inner walls, outer walls and / or transition walls or other support pillars. In this specific example, the support 2800 also has twelve longitudinal struts, each corresponding to a clock hour position from 12 o'clock to 11 o'clock at the location of a single ring or pair of rings 2806a-o. Three separate tethers 2804a-2804c are provided, wherein the first tether 2802a includes ends 2804a and 2804b fixedly attached to rings 2806m and 2806e, respectively, and slidably engaged to rings 2806n-o, cd, and the pair of rings 2806a-b, with a loop 2808a pulled out between them. Similarly, tether 2802b includes ends 2804c and 2804d fixedly attached to rings 2806c and 2806j, and slidably engaged to single rings 2806d-e, hi, and the pair of rings 2806f-g, with a loop 2808b pulled out between them. Finally, the tether 2802c includes ends 2804e and 2804f respectively fixedly attached to rings 2806h and 2806o, and slidably engaged to single rings 2806i-j and mn, and paired rings 2806k-l, with loops 2808c pulled out or engaged between them. In other support structures with different numbers of tether retaining rings or structures, if the number of tether lines remains the same, each tether maintains the same relative configuration of the attachment structure and the paired retaining structure, but the individual retaining structure located between the attachment structure and the paired retaining structure will be absent or include an additional slidably engaged retaining structure. In some further variations, with a greater number of longitudinal supports or tether retaining structures, a greater number of tether lines can be provided to maintain a similar arrangement for each tether.

[0173] Figure 29 One embodiment of the tethering configuration of the support 2900 is depicted, which includes... Figure 27The tie configuration of the middle support 2700 consists of multiple non-overlapping ties 2902a-c, differing in that paired tie-holding structures or loops are not provided or otherwise not used for tie-lay stitching. In this variant, the loops 2908a-c of the ties 2902a-c have a wider base that is pulled between two single loops 2906i-a, cd, fg spaced more than 5 or 10 degrees apart (e.g., 30 degrees or more, or 60 degrees or more). In this tie configuration, the ends 2904a-f of each tie 2902a-c are attached to tie-holding structures or loops 2906h, b, e. Each tie 2902a-c has a nominal coverage length of one-third of the support circumference or a 120-degree arc. Each tethered retaining structure 2906h, b, e is attached to two tethers 2902a-c, and single loops 2906i-a, cd, fg spaced 60 degrees apart are also supported and pulled out to engage tether loops 2908a-c of the delivery system. This depicted tether configuration is applicable to any circumferential tether configuration location described herein, such as the ends and / or joints of inner walls, outer walls, and / or transition walls or other support pillars. In this specific example, the support 2900 has twelve longitudinal pillars, corresponding to the clock hour positions 12 o'clock to 11 o'clock at each location. Positions 2910a-c spaced 120 degrees apart lack any tethered retaining structures or loops. Three separate tethers 2904ac are provided, wherein the first tether 2902a includes ends 2904a-b respectively fixedly attached to rings 2906h and 2906b, and slidably engaged to single rings 2906i and 2906a, with a loop 2908a pulled out between them. Similarly, tether 2902b includes ends 2904c-d fixedly attached to rings 2906b and 2906e, and slidably engaged to single rings 2906c-d, with a loop 2908b pulled out between them. Finally, tether 2902c includes ends 2904e-f respectively fixedly attached to rings 2906e and 2906h, and slidably engaged to single rings 2906f-g, with a loop 2908c pulled out or engaged between them. In other support structures with different numbers of tethered retaining rings or structures, if the number of tethered lines remains the same, each tether maintains the same relative configuration of the attachment structure and the paired retaining structure, but the individual retaining structure located between the attachment structure and the paired retaining structure will be absent or will include an additional slidable engagement retaining structure. In some further variations, with a greater number of longitudinal supports or tethered retaining structures, an even greater number of tethered lines can be provided to maintain a similar arrangement for each tether.

[0174] In yet another variation of the exemplary tether configuration that can be used with the support assembly, Figure 30AA support 3000 is depicted, comprising a plurality of tethering lines 3002a-c that are complete and form a closed shape, for example, without any ends or wherein the ends of the tethering lines are tied together to form a closed shape. Figure 30A In the depicted variant, each tether line 3002a-c slidably passes through each tether retaining structure 3006a-o. The loops 3008a-c of each tether line 3002a-c still have corresponding double tether retaining structures 3006a-b, 3006f-g, 3006k-l to support their loops 3008a-c. However, in other variants, no double tether retaining structures are provided at any path location, and each tether loop can be supported by separate single tether retaining structures located at uniformly circumferentially positioned locations along the circumferential tether path. In some variants, the closed loop tether 3002a-c allows the tether 3002a-c to slide about the circumferential tether path without any mechanical restriction, such as only the frictional resistance between the tether retaining structure and the tether. However, in other variants, such as Figure 30B As shown, the closed-shape tether 3002a-c can still be attached to one of the tether retaining structures 3006a-o. In this variation, each tether loop 3002a-c still has a double tether retaining structure or a pair of tether retaining structures 3006a-b, 3006f-g, 3006k-l to support its loop 3008a-c. Furthermore, each closed-shape tether loop 3002a-c is also attached to one or more other tether retaining structures 3006h-j, 3006m-o, 3006c-e. In some further variations, the tether retaining structures are located circumferentially opposite to the loops 3008a-c of the tether 3002a-c, such as tether retaining structures 3006i, 3006n, 3006d. Attachment can be made, for example, using adhesives, thermoplastic polymers, stitching, or clips. In some variations, one location of the closed-shape tether can be replaced by direct attachment to a support post. In other embodiments, one or more blocking structures can be attached to the tether to restrict its passage between two tether holding structures, but not directly attached to the tether (whether closed-shape or open-shape with two ends). Depending on the size of the blocking structure, some limited movement may be provided between the two tether holding structures.

[0175] In some embodiments of a stent assembly with two tether configurations, each tether configuration may have the same number of tethers, the same number of tether retention structures or loops at similar stent locations between the engagement position and the stent end position, the same relative tether attachment positions, and / or the same overlapping or non-overlapping arrangement. However, in other variations, the two tether configurations may differ. For example, the number of tethers may differ and / or the use of overlapping or non-overlapping tethers may differ. In some variations, the ventricular or outflow end of the stent assembly may utilize an overlapping tether configuration as described herein, while the atrial or inflow end of the stent assembly may utilize a non-overlapping tether configuration as described herein. In yet another variation, the ventricular or outflow end of the stent assembly may utilize a non-overlapping tether configuration as described herein, while the atrial or inflow end of the stent assembly may utilize an overlapping tether configuration as described herein.

[0176] The process of laying the stitches disclosed herein is not limited to... Figure 24 , Figure 25 and Figures 27 to 29 The suture placement process is discussed. In some embodiments of a stent assembly with two tether configurations, each tether configuration may have the same number of tethers, the same number of tether retention structures or loops at similar stent positions between the engagement position and the stent end position, the same relative tether attachment positions, and the same overlapping or non-overlapping arrangement. However, in other variations, the two tether configurations may differ. For example, the number of tethers may differ and / or the use of overlapping or non-overlapping tethers may differ. In some variations, the ventricular or outflow end of the stent assembly may utilize an overlapping tether configuration as described herein, while the atrial or inflow end of the stent assembly may utilize a non-overlapping tether configuration as described herein. In yet another variation, the ventricular or outflow end of the stent assembly may utilize a non-overlapping tether configuration as described herein, while the atrial or inflow end of the stent assembly may utilize an overlapping tether configuration as described herein.

[0177] In addition, Figure 24 and Figure 26 and Figures 27 to 29 In the specific example shown, the exemplary stent structure is configured with 12 longitudinal struts to provide uniform and distributed support for the tricuspid heart valve. The number of rings in the exemplary embodiment is also adapted to correspond to the number of struts, which in turn is related to the number of commissures of the tricuspid heart valve; for example, the number of longitudinal struts is four times the number of commissures. However, in other embodiments, different multiples can be used, such as 1, 2, 3, 5 times, or multiples in the range of 1 to 4 times, 2 to 5 times, or 3 to 5 times. Different numbers of tethers can also be used, such as two or four tethers at each stent end. Therefore, Figure 24 and Figure 25 The exemplary ring configuration shown can be adapted to other support configurations.

[0178] manufacture In some variations, the scaffold structure can be fabricated using a superelastic nitinol tube, which is laser-cut with various slits and slots to achieve the initial tubular scaffold shape. Then, in a series of cyclic deformation, heating, and cooling steps, the tubular scaffold is progressively expanded to at least the initial size of the scaffold structure's internal cavity. The portions of the scaffold structure corresponding to the transition wall and outer wall are then further progressively expanded to the desired diameter, followed by progressive outward turning using a mandrel to form the outer wall, and progressive reduction of the middle region of the outer wall, or further expansion of the upstream and downstream end regions of the outer wall, to achieve a reduced diameter shape for the outer wall. In another step, one or more curved regions on the transverse struts surrounding the middle region are radially displaced outward to form retaining barbs or structures.

[0179] 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 progressively expand the tube to at least the initial size of the outer cavity of the support structure. Then, portions of the support structure corresponding to the transition wall and inner wall are folded inward into the outer wall to form closed ends and an inner wall. The outer wall may be further progressively expanded or adjusted to a desired shape, for example, by further expanding the open and closed end regions of the outer wall, or by reducing the cross-sectional dimensions or diameter of the intermediate region. One or more curved regions on the transverse struts surrounding the intermediate region may also be radially displaced outward to form retaining barbs or structures.

[0180] Valve loading and delivery As previously described, multiple control holes can be provided on the stent structure, which can be used to attach one or more sutures to control the expansion and contraction of different areas on the stent structure, and / or one or more hooks to releasably retain the stent structure until it finally unfolds at the treatment site. In other examples, sutures or wrappings can be placed on the outside of one or more areas of the stent structure instead of using control holes.

[0181] In some examples, sutures can be tensioned or tightened to collapse the outer and inner walls of the stent structure for loading onto the delivery catheter. The sutures can be manipulated to collapse the inner wall first, then the outer wall, or both simultaneously. Similarly, one end of the inner or outer wall can collapse first, or both ends of the inner or outer wall can collapse simultaneously. This can be done at room temperature or in a sterile cold water or ice water bath during use or manufacturing. After collapse, the sheath can extend distally to the distal catheter portion where the replacement valve is located. The valve can also be flushed with sterile saline prior to loading to remove any residual preservatives.

[0182] In some variations, the transition wall of the support structure folds downward at the inner joint, such that in the collapsed configuration, the transition wall is directly above the delivery conduit or tool, just like the inner wall. However, in other examples, the outer wall is pulled distally during collapse and loading, and the transition wall unfolds at the outer joint, such that when contracted into the collapsed configuration, the transition wall is located radially outward from the inner wall.

[0183] The retention suture of the delivery system can be controlled by the user proximally via a pull ring, sliding bar, and / or rotary knob, which are also configured to lock in place via a bias spring or a mechanical interlocking locking configuration known in the art, except during movement. The proximity of the delivery system can also be robotically controlled using any of a variety of robotic catheter guidance systems known in the art. Except for any flushing lumen, guidewire lumen, or diversion line lumen provided (including quick-change guidewire configurations), the suture can slide along one or more lumens of the delivery catheter. The suture can exit at different locations around the distal region of the delivery catheter and can exit around the distal region of the catheter via multiple openings. The multiple openings can be circumferentially and / or longitudinally spaced around the catheter body, depending on the stent structure region controlled by the suture.

[0184] In an exemplary method of delivering a replacement valve, the patient is placed on an operating table and draped and disinfected in the usual manner. Anesthesia or sedation is administered. A percutaneous or incisional access to the femoral vein is established and a guidewire is inserted. The guidewire is manipulated to reach the right atrium, and then the interatrial septum is positioned and punctured using a Brockenbrough needle to obtain access to the left atrium. Alternatively, image guidance can be used to detect the presence of a patent foramen ovale or a residual access available, allowing the guidewire to pass through a pre-existing anatomical opening. A balloon catheter can also be used to enlarge the opening across the interatrial septum if necessary. An electrocautery catheter can also be used to create an opening in the interatrial septum. Once in the left atrium, the guidewire is passed through the mitral valve and into the left ventricle. A pre-shaped guiding catheter or a balloon catheter can be used to facilitate crossing the mitral valve. Once in the left ventricle, a delivery catheter with the replacement valve is inserted over the guidewire.

[0185] Reference Figure 8A A delivery system 800, comprising a delivery catheter 802 and a valve 804, is positioned across the mitral valve orifice 806. The delivery system 800 can be further manipulated to adjust the entry angle through the mitral valve orifice 806, making it approximately orthogonal to the native valve orifice and / or centrally aligned with the mitral valve orifice 806. Once the desired catheter orientation is achieved, the delivery sheath 808 is proximally withdrawn to expose the collapsed valve 804.

[0186] exist Figure 8B In this process, the set of sutures controlling the release downstream of the outer wall 812 of valve 804 or at the ventricular end 810 is partially released, while the tension members controlling the inner wall 816 remain taut. Next, in Figure 8CIn this embodiment, the ventricular end 810 of the outer wall 812 of valve 804 is further released, allowing the ventricular end, intermediate region, and further atrial end 814 of the outer wall 812 to expand further, thereby allowing the transition wall 816 of valve 804 to expand at least partially outward. The partial expansion of the atrial end 814 and ventricular end 810 of valve 804 helps to further center and orthogonally align the intermediate region 820 of valve 804 before full release. While the initial expansion of the atrial end 814 of the outer wall 812 in this embodiment is a secondary effect of the partial release from the ventricular end 810 of valve 804 with the release of longitudinal tension, in other examples, independent tension control of the atrial end 814 may be provided.

[0187] exist Figure 8D In this process, the tension members at the ventricular end 810 and the atrial end 814 are further released, simultaneously or individually in a stepwise manner, so that the intermediate region 820 of the outer wall 812 further abuts against the valve opening 806 for engagement. This further expansion of the outer wall 812 also exposes the retaining barbs or protrusions 822 on the outer wall 812. The proper centering and orientation of the valve are reconfirmed to ensure that the valve is not unfolded in a posture of skewness or partial disengagement relative to the mitral valve annulus. In some variations, the tension members can be re-tensioned to re-collapse the valve 804, thereby facilitating the repositioning and / or reorientation of the valve 804. Once confirmed, the tension members of the inner wall 818 can be released, such as Figure 8E As shown, this also allows the outer wall 812 to achieve tetherless dilation against the mitral valve orifice 806. The tension member can then be cut or otherwise released or detached from the valve, and the tension member can be withdrawn into the catheter and optionally the proximal end of the catheter can be withdrawn. The delivery catheter and guidewire can then be withdrawn from the patient, and hemostasis can be achieved at the femoral vein site.

[0188] In an exemplary method of delivering a replacement valve, the patient is placed on an operating table and draped and disinfected in the usual manner. Anesthesia or sedation is administered. A percutaneous or incisional access to the blood vessel or access site (e.g., femoral vein, femoral artery, radial artery, subclavian artery) is established, and a guidewire is inserted. The guidewire is manipulated to reach the desired valve implantation site. A pre-shaped guiding catheter or balloon catheter may be used to facilitate crossing the valve implantation site.

[0189] Reference Figure 8A A delivery system 800, comprising a delivery catheter 802 and a valve 804, is positioned across the valve orifice 806. The delivery system 800 can be further manipulated to adjust the entry angle through the valve orifice 806 to be approximately orthogonal to and / or centered with the native valve orifice 806. Once the desired catheter orientation is achieved, the delivery sheath 808 is proximally withdrawn to expose the collapsed valve 804.

[0190] exist Figure 8BIn the middle, the tension members controlling the release of the outer wall 812 downstream end 810 of the valve 804 are partially released, while the tension members controlling the inner wall 816 remain taut. Next, in Figure 8C In this embodiment, the downstream end 810 of the outer wall 812 of valve 804 is further released, allowing the downstream end 812, the intermediate region 820, and further upstream end 814 of the outer wall 812 to expand further, thereby allowing the transition wall 816 of valve 804 to expand at least partially outward. The partial expansion of the atrial end 814 and the ventricular end 810 of valve 804 helps to further center and orthogonally align the intermediate region 820 of valve 804 before full release. While the initial expansion of the atrial end 814 of the outer wall 812 in this embodiment is a secondary effect of the partial release from the ventricular end 810 of valve 804 with the release of longitudinal tension, in other examples, independent tension control of the upstream end 814 may be provided.

[0191] exist Figure 8D In the middle, the tension members at the downstream end 810 and the upstream end 814 are further released, simultaneously or individually in a stepwise manner, so that the intermediate region 820 of the outer wall 812 further abuts against the valve opening 806 for engagement. This further expansion of the outer wall 812 also exposes the retaining barbs or protrusions 822 on the outer wall 812. The proper centering and orientation of the valve are reconfirmed to ensure that the valve is not unfolded in a posture of skewness or partial disengagement relative to the valve annulus. The tension members may optionally be re-tensioned to re-collapse the valve 804, thereby facilitating the repositioning and / or reorientation of the valve 804. Once confirmed, the tension members of the inner wall 818 are released, such as Figure 8E As shown, this also allows the outer wall 812 to achieve tetherless dilation against the mitral valve orifice 806. The tension member can then be disengaged from the valve 804 and withdrawn from the catheter, and optionally the proximal end of the catheter 804 can be withdrawn.

[0192] In yet another exemplary method of delivering a replacement valve, the patient is placed on an operating table and draped and disinfected in the usual manner. Anesthesia or sedation is administered, with selective ventilation of the right lung and optionally ventilation of the upper lobe of the left lung to allow controlled collapse of the lower lobe of the left lung. A purse-string suture is placed at the apex or other cardiac access site. A cannula is inserted through a cannula or guide with a proximal hemostatic valve, and the cannula assembly is inserted through the purse-string suture to access the heart chamber and the target valve.

[0193] Reference Figure 8A A delivery system 800, comprising a delivery rigid tool 802 and a valve 804, is positioned across the valve orifice 806. The delivery system 800 can be further manipulated to adjust the entry angle through the valve orifice 806 to be approximately orthogonal to and / or centered with the native valve orifice 806. Once the desired tool orientation is achieved, a delivery sheath 808 (if any) is withdrawn proximally to expose the collapsed valve 804.

[0194] exist Figure 8B In the middle, the tension member controlling the release of the outer wall 812 downstream end 810 of the valve 804 is partially released, while the suture controlling the inner wall 816 remains taut. Next, in Figure 8C In this embodiment, the downstream end 810 of the outer wall 812 of valve 804 is further released, allowing the downstream end 812, the intermediate region 820, and further upstream end 814 of the outer wall 812 to expand further, thereby allowing the transition wall 816 of valve 804 to expand at least partially outward. The partial expansion of the atrial end 814 and the ventricular end 810 of valve 804 helps to further center and orthogonally align the intermediate region 820 of valve 804 before full release. While the initial expansion of the atrial end 814 of the outer wall 812 in this embodiment is a secondary effect of the partial release from the ventricular end 810 of valve 804 with the release of longitudinal tension, in other examples, independent suture control is used. exist Figure 8D In the middle, the tension members at the downstream end 810 and the upstream end 814 are further released, simultaneously or individually in a stepwise manner, so that the intermediate region 820 of the outer wall 812 further abuts against the valve opening 806 for engagement. This further expansion of the outer wall 812 also exposes the retaining barbs or protrusions 822 on the outer wall 812. Optionally, the tension members can be re-tensioned to re-collapse the valve 804, thereby facilitating the repositioning and / or reorientation of the valve 804. The proper centering and orientation of the valve are reconfirmed to ensure that the valve has not unfolded in a posture of skew or partial disengagement relative to the valve annulus. Once confirmed, the tension members of the inner wall 818 are released, such as Figure 8E As shown, this also allows the outer wall 812 to achieve tetherless dilation against the mitral valve orifice 806. The suture can then be cut and the severed end withdrawn into the catheter, and optionally the proximal end of the delivery tool 802 can be withdrawn.

[0195] In some further variations, one or more rings or coils may be attached to the support structure to facilitate the attachment of tension members. Compared to support struts, rings may include smoother surfaces through which tension members slide. Rings may be directly attached to the support structure or disposed within openings in the support structure. The latter configuration allows the rings to move or rotate within the openings, which can help orient the tension direction between the tension member and the strut attachment area. Figures 9A to 9C Various openings 904, 906, and 908 that can be disposed on the bracket 900 are depicted. In these specific examples, openings 904, 906, and 908 are located on the longitudinal struts 902 of the bracket 900, but in other variations, such as Figure 10 As depicted, opening 1002 may be located on the lateral or circumferential support 1004 of bracket 1000. Rings or coils 910, 1010 may include, for example... Figure 10The depicted circular shape, however, may be elliptical, square, rectangular, or other polygonal or curved closed shapes in other variations. The loop or coil may be formed from round wire with diameters ranging from, for example, 0.001” to 0.100”, 0.005” to 0.050”, or 0.007” to 0.020”, and may include loops or other shapes with diameters or maximum internal opening dimensions ranging from, for example, 0.010” to 0.5”, 0.010” to 0.3”, 0.10” to 0.1”, 0.010” to 0.080”, 0.015” to 0.075”, 0.020” to 0.70”, 0.25” to 0.65”. In some variations, the loops attached to the support structure may have different sizes, depending on the dimensional constraints of a particular location, to provide greater flexibility in the orientation of the tension member. The wire may include titanium, stainless steel, nitinol, cobalt-chromium alloy, or other biocompatible wires. The wire can be square-cut to provide flat end faces for joining them together, or beveled to increase the surface area for forming the joint. The wire can be crimped into the opening, and the ends of the wire can be joined by laser welding butt joints. The support structure and the ring can be further processed together, such as passivation. In some variations, the ring opening formed in the support structure can have the same or different shape as the cross-sectional shape of the ring, and the relative dimensions can be up to 110%, 120%, 130%, 140%, 150%, 200%, 250%, or 300% of the wire diameter or the maximum transverse cross-sectional dimension of the wire. The position of the ring opening relative to the end of the support can also be characterized relative to the wire diameter or the maximum transverse cross-sectional dimension of the wire, for example, up to 150%, 200%, 250%, 300%, 400%, or 500% or more from the end of the support or support segment.

[0196] Figure 10 Other embodiments of the support ring are schematically depicted, including a ring 1010 fixedly welded to the end 1006 of the longitudinal strut 1008 of the support 1000, a ring 1010 slidably positioned along the circumferential strut 1004, and a ring 1010 located in the opening 1002 of the circumferential strut 1004.

[0197] Figure 26A Another exemplary embodiment of a stitched or tethered retention structure 2602, 2604 that can be coupled to a bracket 2600 is depicted. In this particular embodiment, a tethered retention loop 2602 is disposed on the distal tip 2606 of the outer wall 2608 of the bracket 2600. (See also...) Figure 26B and Figure 26C The distal tip 2606 may include one or more openings or holes 2610a, 2610b to facilitate attachment of the ring 2602. However, in other variations, holes 2610a-b may be omitted, and alternatively, [other methods may be used]. Figure 26CThe ring 2602 is attached by a recess 2612 formed by a cavity surrounding the barbs 2614. Figure 26C The image depicts attaching a ring 2602 to a distal tip 2606 using a crisscross pattern of suture 2616. The suture 2616 passes through a hole 2610a, then diagonally through an opening 2618 of the ring 2602, then through another hole 2610b, then diagonally through the opening 2618 of the ring 2602 in the opposite direction, and then back through the first hole 2610a. This crisscross suture arrangement can be performed 2 to 8 times, 2 to 6 times, 2 to 5 times, 2 to 4 times, or 2 or 3 times, after which the suture is knotted and cut to secure the ring 2602. Depending on the mechanical properties of the suture and / or the number of suture arrangements used to attach the ring 2602, the ring 2602 may or may not be able to move, tilt, or pivot relative to the distal tip 2606.

[0198] Figure 26A Another tethered retaining structure or ring 2604 is also depicted at a different location on the outer wall 2608, closer to the transition wall 2620 of the support 2600. At this location, also as... Figure 26D As depicted, ring 2604 is located at the junction 2622 of the transverse support 2624 and the longitudinal support 2626 of the outer wall 2608. The stitch 2628 is installed using attachment holes (such as those provided in the support pillars) in the bracket. Figure 26B and Figure 26C (As depicted), if any. However, in Figure 26D and Figure 26E In this configuration, no attachment hole is provided; therefore, the cross-stitching of the seam 2628 between the joint 2622 and the opening 2630 of the ring 2618 can be replaced by utilizing the acute-angled groove 2632 formed between the angled transverse support 2624 and the longitudinal support 2626. The cross-stitching at this location can also be performed 2 to 8 times, 2 to 6 times, 2 to 5 times, 2 to 4 times, or 2 or 3 times, after which the seam is knotted and cut to secure the ring 2602. Furthermore, due to the availability of supports 2624, 2626 around the joint 2622, the seam 2628 can optionally be wrapped around one or more supports once or multiple times before, after, or between the cross-stitching pattern of the seam 2628. For example, in… Figure 26E In the illustrated exemplary embodiment, the suture 2628 is wrapped three times around the longitudinal post 2626, which is away from the two angled transverse posts 2624, before being laid in a cross pattern.

[0199] In some variations, a single ring 2602, 2604 may be attached to each distal tip 2606 or joint 2622 of the support structure 2600. However, depending on the arrangement or configuration of the tethering lines used with the rings 2602 of the support 2600, two rings 2602, 2604 may be provided in some locations instead of a single ring 2602, 2604, such as... Figure 26Fand Figure 26G As depicted. Alternatively, some distal tips 2606 or joints 2622 may be completely without loops. Two loops 2602, 2604 may be provided at a single distal tip 2606 or joint 2622, where the tether line loops away from the circumferential tether path, thus providing a narrower loop base. In other variations, if a wider loop base from two spaced loop locations is preferred, loops may be omitted or not used at all. Potential arrangements and configurations.

[0200] Although these embodiments have been specifically shown and described with reference to embodiments herein, those skilled in the art will understand that various changes in form and detail may be made therein without departing from the scope of these embodiments. For all embodiments described above, the steps of the method need not be performed sequentially.

Claims

1. A support assembly, characterized in that, include: An expandable support includes a strut arrangement forming an outer wall, the outer wall including a first end region, a second end region, and an intermediate region located between the two; Multiple tethered retaining structures are arranged circumferentially around a first end region of the support and define circumferential tethered paths; A plurality of tether path positions evenly spaced along the circumferential tether path, wherein each of the tether retaining structures is located at one of the tether path positions, and wherein each tether path position includes; A plurality of tethers, wherein each of the plurality of tethers includes a main region located on the circumferential tether path and a loop formed between two tether holding structures away from the circumferential tether path, and wherein each of the plurality of tethers overlaps with at least one other tether along the circumferential tether path.

2. The support assembly according to claim 1, characterized in that, The main region of each of the plurality of tethers includes a first end region having a first end, a second end region having a second end, and an intermediate region located between the two and containing a loop of the tether.

3. The support assembly according to claim 2, characterized in that, Each first and second end of each tether is fixedly attached to one of the plurality of tether path locations, or directly to the outer wall, or to the tether holding structure.

4. The support assembly according to claim 2, characterized in that, Each tether path location includes at least one tether holding structure, and at least one tether path location includes two tether holding structures, wherein a central region of one of the tethers is configured to slidably pass through the two tether holding structures, and a loop of a tether is formed between the two tether holding structures away from the circumferential tether path.

5. The support assembly according to claim 4, characterized in that, The at least one tether path position including two tether holding structures includes a plurality of tether path positions, each tether path position having two tether holding structures, the number of tether path positions corresponding to the number of the plurality of tethers.

6. The support assembly according to claim 2, characterized in that, Each first end region and each second end region of each tether can slide through at least one first tether holding structure at a tether path position different from the tether path position of the corresponding first end and second end.

7. The support assembly according to claim 2, characterized in that, Each of the plurality of said tether path locations, which is fixedly attached to the first or second end of one of the tethers, is not fixedly attached to any other tether.

8. The support assembly according to claim 2, characterized in that, Each tether retaining structure, which is fixedly attached to the first or second end of one of the tethers, is also slidably traversed by different tethers.

9. The support assembly according to claim 4, characterized in that, Each of the plurality of tethers is configured to: It can slide through one of the plurality of tethered retaining structures, without any other first tether sliding through or attached to the tethered retaining structure; A tether can slide through one of the plurality of tethered retaining structures, while another tether can also slide through; and It is fixedly attached to two tethered retaining structures, which are also slidably passed through by another first tether.

10. The support assembly according to claim 2, characterized in that, The number of tether path locations is a multiple of three, and the plurality of first tethers includes three tethers.

11. The support assembly according to claim 9, characterized in that, The number of tethering path locations includes twelve tethering path locations.

12. The support assembly according to claim 11, characterized in that, The twelve tethering path positions are consecutive tethering path positions, including the first, second, third, fourth, fifth, sixth, seventh, eighth, ninth, tenth, eleventh and twelfth path positions. The fourth, eighth and twelfth tethering path positions each include two first tethering retention structures, and the first, second, third, fifth, sixth, seventh, ninth, tenth and eleventh tethering path positions each include one first tethering retention structure.

13. The support assembly according to claim 1, characterized in that, Each of the plurality of tethers overlaps with at least two other tethers along the circumferential tether path.

14. The support assembly according to claim 2, characterized in that: The plurality of tethered retaining structures are a plurality of first tethered retaining structures, and the circumferential tethered path is a first circumferential tethered path; The multiple tethering path locations are multiple first tethering path locations; and The support assembly further includes: A plurality of second tether retention structures are arranged circumferentially around the second end region of the expandable support and define a second circumferential tether path; Multiple second tether path locations, the multiple second tether path locations being evenly spaced along the second circumferential tether path, wherein each of the second tether retaining structures is located at one of the first tether path locations, and wherein each second tether path location includes zero second tether retaining structures, one second tether retaining structure, or two second retaining structures; A plurality of second tethers, wherein each of the plurality of second tethers includes a main region located on the circumferential tether path and a loop forming a loop between two tether holding structures away from the circumferential tether path.

15. The support assembly according to claim 14, characterized in that, Each of the plurality of second tethers overlaps with at least one other second tether along the second circumferential tether path.

16. The support assembly according to claim 14, characterized in that, The main region of each of the plurality of tethers includes a first end region having a first end, a second end region having a second end, and an intermediate region located between the two and containing a loop of the tether.

17. The support assembly according to claim 16, characterized in that: Each first end and each second end of each second tether are fixedly attached to one of the plurality of second tether path locations, or directly to a support of the outer wall, or to a second tether retaining structure.

18. The support assembly according to claim 14, characterized in that, The plurality of second tethers are arranged in a non-overlapping manner.

19. The support assembly according to claim 14, characterized in that, The plurality of second tethers are arranged in an overlapping manner.

20. The support assembly according to claim 14, characterized in that, The relative configurations of the plurality of first tether holding structures and the plurality of first tethers along the first circumferential tether path are the same as the relative configurations of the plurality of second tether holding structures and the plurality of second tethers along the second circumferential tether path.

21. The support assembly according to claim 1, characterized in that, The support also includes an inner wall and a transition wall between the inner wall and the transition wall, wherein the transition wall is located in the first end region of the support.

22. The support assembly according to claim 1, characterized in that, Each of the plurality of tethered retaining structures includes an opening having a lateral or tangential orientation relative to the outer wall of the support.

23. The support assembly according to claim 1, characterized in that, Each of the plurality of tethered retaining structures includes a loop, hoop, or clamp.

24. The support assembly according to claim 1, characterized in that, Each of the plurality of tethered retaining structures is fixedly attached to or continuously formed with respect to the outer wall of the support.

25. The support assembly according to claim 1, characterized in that, Each of the plurality of tethered retaining structures is movably or pivotally attached to the outer wall of the support via stitches or wires.

26. The support assembly according to claim 1, characterized in that, The support assembly also includes a support cover, and each of the plurality of first tethered retaining structures is further attached to the support cover via the stitching or thread.

27. The support assembly according to claim 1, characterized in that, Each of the plurality of tethering path locations is located at a longitudinal support of the support arrangement.

28. The support assembly according to claim 2, characterized in that, At least one of the first and second end regions of each of the plurality of tethers overlaps with itself along the circumferential tether path.

29. The support assembly according to claim 1, characterized in that, At least one of the multiple tether path locations lacks a tether retention structure.

30. The support assembly according to claim 29, characterized in that, The at least one of the plurality of tether path locations lacking a tether retention structure corresponds in number to the plurality of tethers.

31. The support assembly according to claim 20, characterized in that, Each of the first plurality of tethered retaining structures protrudes radially outward from the outer wall of the support.

32. A replacement heart valve, characterized in that, include: An integrated support frame includes multiple longitudinal supports and multiple circumferential supports, the multiple longitudinal supports and multiple circumferential supports forming a tubular inner wall with a central cavity and an outer wall surrounding the tubular inner wall; Replacement leaflet valve, the replacement leaflet valve being located in the central lumen of the tubular inner wall and connected to the tubular inner wall; and A bracket, which is connected to the junction between two adjacent leaflets of the replacement leaflet and to the tubular inner wall; The integrated support frame includes a collapsed configuration and an expanded configuration.

33. The replacement heart valve according to claim 32, characterized in that, The bracket is U-shaped and has a first arm and a second arm that slide over the two adjacent leaflets and the connecting portion, wherein a portion of each leaflet is disposed on the inner and outer surfaces of the first and second arms of the bracket.

34. The replacement heart valve according to claim 33, characterized in that, Each arm of the bracket also includes multiple holes, and one of the multiple longitudinal struts includes multiple holes, wherein the bracket is sewn to the adjacent leaflet and sewn to the longitudinal strut.

35. The replacement heart valve according to claim 34, characterized in that, The bracket is sewn to the adjacent leaflets with at least one suture, wherein each of the at least one suture passes through one of the plurality of holes in the longitudinal pillar of the plurality of longitudinal supports, through the everted layer of one of the adjacent leaflets, through the corresponding hole in the first arm of the bracket, through the bonding layer of the adjacent leaflet, through the corresponding hole in the second arm of the bracket, through the everted layer of another adjacent leaflet, and back through the first hole in the plurality of holes in the longitudinal pillar of the plurality of longitudinal supports to form a loop.

36. The replacement heart valve according to claim 35, characterized in that, Each suture also passes through adjacent holes in the plurality of holes of the longitudinal struts, through the eversion layer of one of the adjacent leaflets, through adjacent corresponding holes in the first arm of the bracket, through the bonding layer of the adjacent leaflet, through adjacent corresponding holes in the second arm of the bracket, through the eversion layer of another adjacent leaflet, and back through adjacent holes in the plurality of holes of the longitudinal struts.

37. The replacement heart valve according to claim 33, characterized in that, Each leaflet comprises a layer located within the bracket and a layer disposed outside the bracket.

38. The replacement heart valve according to claim 33, characterized in that, Each leaflet comprises two layers located within the bracket and one layer located outside the bracket.

39. The replacement heart valve according to claim 33, characterized in that, Each leaflet comprises one layer located within the bracket and two layers located outside the bracket.

40. The replacement heart valve according to claim 32, characterized in that, The number of brackets corresponds to the number of leaflets in the replaced leaflet valve.

41. The replacement heart valve according to claim 32, characterized in that, The valve leaflet is a three-leaf valve, and the number of supports is three.

42. The replacement heart valve according to claim 32, characterized in that, It also includes a skirt portion disposed on the outer wall of the integrated support frame, wherein the skirt portion includes a plurality of cutouts disposed on the lower edge of the skirt portion.

43. The replacement heart valve according to claim 42, characterized in that, The plurality of cuts include arc-shaped cuts.

44. The replacement heart valve according to claim 42, characterized in that, Each of the plurality of cuts is disposed between the extensions of the skirt, and each extension is aligned with a longitudinal post of the outer wall of the integral support frame.

45. The replacement heart valve according to claim 42, characterized in that, The support frame also includes a plurality of tissue barbs formed within the longitudinal struts and surrounded by elongated cavities.

46. ​​The replacement heart valve according to claim 45, characterized in that, The skirt also includes pre-formed elongated grooves corresponding to the locations of the plurality of tissue barbs.

47. The replacement heart valve according to claim 32, characterized in that, It also includes a plurality of ring structures connected to the integrated support frame, wherein each of the plurality of ring structures comprises: Ring; and The extension extending from the ring, The extension includes a plurality of holes for securing the ring structure to the integral support frame.

48. The replacement heart valve according to claim 47, characterized in that, The multiple ring structures are connected to the atrial side of the integrated stent frame.

49. The replacement heart valve according to claim 32, characterized in that, The plurality of longitudinal struts transition from straight longitudinal struts in the tubular inner wall to curved longitudinal struts in the outer wall via a transition wall between the outer wall and the tubular inner wall.

50. The replacement heart valve according to claim 49, characterized in that, The transition wall tapers at a predetermined angle relative to the longitudinal axis of the integrated support frame.

51. The replacement heart valve according to claim 49, characterized in that, The multiple longitudinal supports of the outer wall include composite curves that transition from a concave curve to a convex curve, then back to a concave curve, then back to a convex curve, and then back to a concave curve.

52. The replacement heart valve according to claim 51, characterized in that, The first end region of the outer wall includes a circumferential strut projecting radially outward from the outer wall.

53. A replacement heart valve, characterized in that, include: An integrated support frame includes multiple longitudinal supports and multiple circumferential supports, the multiple longitudinal supports and multiple circumferential supports forming a tubular inner wall with a central cavity and an outer wall surrounding the tubular inner wall; Replacement leaflets and valves, which are located in the central lumen of the tubular inner wall and connected to the tubular inner wall; as well as A skirt portion is disposed on the outer wall of the integrated support frame, wherein the skirt portion includes a plurality of cutouts disposed on the lower edge of the skirt portion, and wherein the integrated support frame includes a collapsed configuration and an expanded configuration.

54. The replacement heart valve according to claim 53, characterized in that, The plurality of cuts include arc-shaped cuts.

55. The replacement heart valve according to claim 53, characterized in that, Each of the plurality of cuts is disposed between the extensions of the skirt, and Each extension is aligned with a longitudinal support column on the outer wall of the integrated support frame.

56. The replacement heart valve according to claim 55, characterized in that, Each extension of the skirt comprises a rectangular shape.

57. The replacement heart valve according to claim 55, characterized in that, The support frame also includes a plurality of tissue barbs formed within the longitudinal struts and surrounded by elongated cavities.

58. The replacement heart valve according to claim 57, characterized in that, The skirt also includes pre-formed elongated grooves corresponding to the locations of the plurality of tissue barbs.

59. A replacement heart valve, characterized in that, include: An integrated support frame includes multiple longitudinal supports and multiple circumferential supports, the multiple longitudinal supports and multiple circumferential supports forming a tubular inner wall with a central cavity and an outer wall surrounding the tubular inner wall; Replacement leaflets, which are located in the central lumen of the tubular inner wall and connected to the tubular inner wall; and The integrated support frame includes a collapsed configuration and an expanded configuration.

60. The replacement heart valve according to claim 59, characterized in that, It also includes a plurality of ring structures connected to the integrated support frame, wherein each of the plurality of ring structures comprises: Ring; and The extension extending from the ring, The extension includes a plurality of holes for securing the ring structure to the integral support frame.

61. The replacement heart valve according to claim 60, characterized in that, The multiple ring structures are connected to the atrial side of the integrated stent frame.

62. The replacement heart valve according to claim 59, characterized in that, The plurality of longitudinal struts transition from straight longitudinal struts in the tubular inner wall to curved longitudinal struts in the outer wall via a transition wall between the outer wall and the tubular inner wall.

63. The replacement heart valve according to claim 62, characterized in that, The transition wall tapers at a predetermined angle relative to the longitudinal axis of the integrated support frame.

64. The replacement heart valve according to claim 62, characterized in that, The multiple longitudinal supports of the outer wall include composite curves that transition from a concave curve to a convex curve, then back to a concave curve, then back to a convex curve, and then back to a concave curve.

65. The replacement heart valve according to claim 64, characterized in that, The first end region of the outer wall includes a circumferential strut projecting radially outward from the outer wall.

66. A replacement heart valve, characterized in that, include: An integrated support frame having a collapsed configuration and an expanded configuration, the integrated support frame comprising: The inner wall of the central cavity is defined; The outer wall is radially spaced from the inner wall; Multiple longitudinal struts, wherein the multiple longitudinal struts transition from straight longitudinal struts in the inner wall to curved longitudinal struts in the outer wall via a transition wall between the outer wall and the inner wall; A plurality of inner circumferential struts forming the inner wall and a plurality of outer circumferential struts forming the outer wall; Multiple lateral protrusions project radially outward from the outer wall and extend circumferentially around the outer wall of the integral support frame, wherein each lateral protrusion includes a pair of angled legs connected at the apex of the lateral protrusion, wherein the lateral protrusion includes a compound curve with an inflection point that transitions each lateral protrusion from a concave curve at the longitudinal support of the outer wall to a convex curve; and The replacement leaflet valve is located in the central cavity of the inner wall.

67. The replacement heart valve according to claim 66, characterized in that, The multiple longitudinal supports of the outer wall include composite curves that transition from a concave curve to a convex curve, then back to a concave curve, then back to a convex curve, and then back to a concave curve.

68. A stent valve, characterized in that, include: An integrated support frame includes multiple longitudinal supports and multiple circumferential supports, the multiple longitudinal supports and multiple circumferential supports forming a tubular inner wall with a central cavity and an outer wall surrounding the tubular inner wall; Replacement leaflet valve, wherein the replacement leaflet valve is located in the central cavity of the tubular inner wall and connected to the tubular inner wall; Multiple rings are connected to the integrated support frame, and the multiple rings are equally spaced around the circumference of the integrated support frame. The multiple rings include a first anchoring ring, a first ring subset including at least one continuous ring adjacent to the first anchoring ring, a second anchoring ring adjacent to the first ring subset, a second ring subset including at least one continuous ring adjacent to the second anchoring ring, a continuous ring subset, a third anchoring ring adjacent to the second ring subset, and a third ring subset including at least one continuous ring adjacent to the third anchoring ring. A first seam segment is attached to the first anchoring ring and passes through the first ring subset and the second ring subset, while skipping the second anchoring ring and attaching to the third anchoring ring; The second seam segment is attached to the third anchoring ring and passes through the third ring subset and the first ring subset, while skipping the first anchoring ring and attaching to the second anchoring ring; as well as The third seam segment is attached to the second anchoring ring and passes through the second ring subset and the third ring subset, while skipping the third anchoring ring and attaching to the first anchoring ring.

69. The stent valve according to claim 68, characterized in that, The first suture segment, the second suture segment, and the third suture segment each consist of a continuous suture.

70. The stent valve according to claim 68, characterized in that, The first, second, and third suture segments each consist of separate sutures.

71. The stent valve according to claim 68, characterized in that, The first ring subset, the second ring subset, and the third ring subset each contain the same number of rings.

72. The stent valve according to claim 68, characterized in that, The plurality of rings includes twelve rings, wherein: The first anchoring ring is the sixth ring among the plurality of rings; The first ring subset includes the seventh, eighth, and ninth rings among the plurality of rings; The second anchoring ring is the tenth ring among the plurality of rings; The second ring subset includes the eleventh ring, the twelfth ring, and the first ring among the plurality of rings; The third anchoring ring is the second ring among the plurality of rings; and The third ring subset includes the third ring, the fourth ring, and the fifth ring among the plurality of rings.

73. The stent valve according to claim 68, characterized in that, The plurality of rings includes N rings and X subsets of rings, where N is divisible by X+1.

74. The stent valve according to claim 73, characterized in that, Each of the X ring subsets includes Y rings.

75. The stent valve according to claim 73, characterized in that, Each of the X ring subsets does not overlap with any other X ring subsets.

76. The stent valve according to claim 74, characterized in that, Y=3 and N=12.

77. A stent valve, characterized in that, include: An integrated support frame includes multiple longitudinal supports and multiple circumferential supports, the multiple longitudinal supports and multiple circumferential supports forming a tubular inner wall with a central cavity and an outer wall surrounding the tubular inner wall; Replacement leaflet valve, wherein the replacement leaflet valve is located in the central cavity of the tubular inner wall and connected to the tubular inner wall; Multiple rings are connected to the integrated bracket frame, and the multiple rings are equally spaced around the circumference of the integrated bracket, wherein the relative positions of the rings are defined by positive and negative directions; a first suture segment attached to a first anchoring ring of the plurality of rings, passing through a first X consecutive rings of the plurality of rings adjacent to the first anchoring ring along a first direction, where X>0, skipping Y rings of the plurality of rings adjacent to the first X consecutive rings along the first direction, passing through Z consecutive rings of the plurality of rings along a second direction, where Z is 0 or greater than 1, and Z<X, and if Z=0, attached to the next consecutive ring of the plurality of rings in the first direction, or if Z>0, attached to the next consecutive ring of the plurality of rings in the second direction; a second suture segment attached to the same ring as the first suture segment which is not the first anchoring ring, passing through a second X consecutive rings of the plurality of rings along the first direction, skipping Y rings of the plurality of rings adjacent to the second X consecutive rings along the first direction, passing through Z consecutive rings of the plurality of rings along the second direction, where Z is 0 or greater than 1, and Z<X, and if Z=0, attached to the next consecutive ring of the plurality of rings starting from the second X consecutive rings in the first direction, or if Z>0, attached to the next consecutive ring of the plurality of rings in the second direction; and a third suture segment attached to the same ring as the second suture segment, which corresponds to the next consecutive ring starting from the second X consecutive rings in the first direction if Z=0, or the next consecutive ring in the second direction if Z>0, passing through a third X consecutive rings of the plurality of rings along the first direction, skipping Y rings of the plurality of rings adjacent to the third X consecutive rings along the first direction, passing through Z consecutive rings of the plurality of rings along the second direction, where Z is 0 or greater than 1, and Z<X, and if Z=0, attached to the next consecutive ring starting from the third X consecutive rings in the first direction, or if Z>0, attached to the next consecutive ring in the second direction.

78. The stent valve according to claim 77, characterized in that, X=3, Y=1 and Z=0.

79. The stent valve according to claim 77, characterized in that, X=4, Y=1 and Z=2.

80. The stent valve according to claim 77, characterized in that, X≥2。 81. The stent valve according to claim 78, characterized in that, X-Z=2.

82. The stent valve according to claim 77, characterized in that, The first suture segment, the second suture segment and the third suture segment comprise sequentially connected continuous sections of one continuous suture.

83. The stent valve according to claim 77, characterized in that, The first suture segment, the second suture segment and the third suture segment comprise separate sutures.

84. A stent valve, characterized in that, comprising: a one-piece stent frame comprising a plurality of longitudinal struts and a plurality of circumferential struts, the plurality of longitudinal struts and the plurality of circumferential struts forming a tubular inner wall with a central cavity and an outer wall surrounding the tubular inner wall; a replacement leaflet valve located in the central cavity of the tubular inner wall and coupled to the tubular inner wall; a plurality of rings coupled to the one-piece stent frame, the plurality of rings being equally spaced around the circumference of the one-piece stent; a first segment of a suture, the first segment of the suture is tied to a first anchoring ring of the plurality of rings, the first segment of the suture passes through a first X consecutive rings of the plurality of rings adjacent to the first anchoring ring in a first direction, skips a second anchoring ring of the plurality of rings adjacent to the first consecutive rings, passes through a first Y consecutive rings of the plurality of rings that are fewer in number than the X consecutive rings in a second direction, and is tied to a ring of the first X consecutive rings of the plurality of rings that is closest to the second anchoring ring; a second segment of the suture, the second segment of the suture passes through the second anchoring ring and a second X consecutive rings of the plurality of rings adjacent to the second anchoring ring in the first direction, skips a third anchoring ring of the plurality of rings adjacent to the second X consecutive rings, passes through a second Y consecutive rings of the plurality of rings that are fewer in number than the X consecutive rings in the second direction, and is tied to a ring of the second X consecutive rings that is closest to the third anchoring ring; a third segment of the suture, the third segment of the suture passes through the third anchoring ring and a third X consecutive rings adjacent to the third anchoring ring in the first direction, skips a fourth anchoring ring of the plurality of rings adjacent to the third X consecutive rings, the third segment of the suture is passed through a third Y consecutive rings of the plurality of rings in the second direction, wherein Y<X, and the third segment is tied to the first anchoring ring.

85. The method according to claim 84, characterized in that, The plurality of rings comprises N rings, and wherein N is divisible by X.

86. The method according to claim 84, characterized in that, Y=0。 87. The method according to claim 84, characterized in that, Y=2 and X=4.

88. A method for replacing a valve by collapsing a suture, characterized in that, comprising: obtaining a replacement valve, the replacement valve comprising: a one-piece stent frame, the one-piece stent frame comprising a plurality of longitudinal struts and a plurality of circumferential struts, the plurality of longitudinal struts and the plurality of circumferential struts forming a tubular inner wall having a central lumen and an outer wall surrounding the tubular inner wall; a replacement leaflet valve, the replacement leaflet valve being located in the central lumen of the tubular inner wall and coupled to the tubular inner wall; and a plurality of rings coupled to the one-piece stent frame, the plurality of rings being arranged at equal intervals around the circumference of the one-piece stent frame, the plurality of rings comprising a first anchoring ring, a first subset of rings, a second anchoring ring, a second subset of rings, a third anchoring ring, and a third subset of rings; attaching a first segment of a suture to the first anchoring ring, passing the first segment of the suture through the first subset of rings comprising at least one consecutive ring adjacent to the first anchoring ring, skipping the second anchoring ring adjacent to the first subset of rings, passing the first segment of the suture through the second subset of rings adjacent to the second anchoring ring comprising at least one threaded consecutive ring, and attaching the first segment of the suture to the third anchoring ring adjacent to the second subset of rings; passing a second segment of the suture through the third subset of rings comprising at least one consecutive ring adjacent to the third anchoring ring, skipping the first anchoring ring, passing the second segment of the suture through the first subset of rings, and tying the second segment of the suture to the second anchoring ring; passing a third segment of the suture through the second subset of rings, skipping the third anchoring ring, passing the third segment of the suture through the third subset of rings, and attaching the third segment of the suture to the first anchoring ring.

89. The method according to claim 88, characterized in that, The first subset of rings, the second subset of rings, and the third subset of rings each contain the same number of rings.

90. The method according to claim 89, characterized in that, The plurality of rings includes twelve rings, wherein: The first anchoring ring is the sixth ring of the plurality of rings; The first subset of rings includes the seventh ring, the eighth ring, and the ninth ring of the plurality of rings; The second anchoring ring is the tenth ring of the plurality of rings; The second subset of rings includes the eleventh ring, the twelfth ring, and the first ring of the plurality of rings; The third anchoring ring is the second ring of the plurality of rings; and The third subset of rings includes the third ring, the fourth ring, and the fifth ring of the plurality of rings.

91. The method according to claim 88, characterized in that, The plurality of rings includes N rings and X subsets of rings, wherein N is divisible by X+1.

92. The method according to claim 91, characterized in that, Each of the X subsets of rings includes Y rings.

93. The method according to claim 91, characterized in that, Each of the X subsets of rings does not overlap with any other of the X subsets of rings.

94. The method according to claim 92, characterized in that, Y=3 and N=12.

95. A method for replacing a valve by collapsing a suture, characterized in that, comprising: obtaining a replacement valve, the replacement valve comprising: a unitary stent framework, the unitary stent framework comprising a plurality of longitudinal struts and a plurality of circumferential struts, the plurality of longitudinal struts and the plurality of circumferential struts forming a tubular inner wall having a central lumen and an outer wall surrounding the tubular inner wall; replacement leaflet valves, the replacement leaflet valves being located in the central lumen of the tubular inner wall and coupled to the tubular inner wall; a plurality of rings coupled to the unitary stent framework at equal intervals around the circumference of the unitary stent; tying a first segment of a suture to a first anchoring ring of the plurality of rings, threading the first segment of the suture in a first direction through a first X consecutive rings of the plurality of rings that are immediately adjacent to the first anchoring ring, skipping a second anchoring ring of the plurality of rings that is immediately adjacent to the first consecutive rings, threading the first segment of the suture in a second direction through a first Y consecutive rings of the plurality of rings that are fewer in number than the X consecutive rings, and tying the first segment of the suture to the ring of the first X consecutive rings of the plurality of rings that is closest to the second anchoring ring; threading a second segment of the suture in the first direction through the second anchoring ring and a second X consecutive rings of the plurality of rings that are immediately adjacent to the second anchoring ring, skipping a third anchoring ring of the plurality of rings that is immediately adjacent to the second X consecutive rings, threading the second segment of the suture in the second direction through a second Y consecutive rings of the plurality of rings that are fewer in number than the X consecutive rings, and tying the second segment of the suture to the ring of the second X consecutive rings that is closest to the third anchoring ring; threading a third segment of the suture in the first direction through the third anchoring ring and a third X consecutive rings immediately adjacent to the third anchoring ring, skipping a fourth anchoring ring of the plurality of rings that is immediately adjacent to the third X consecutive rings, threading the third segment of the suture in the second direction through a third Y consecutive rings of the plurality of rings, wherein Y<X, and tying the third segment to the first anchoring ring.

96. The method according to claim 95, characterized in that, The plurality of rings includes N rings, wherein N is divisible by X.

97. The method according to claim 95, characterized in that, Y=0。 98. The method according to claim 95, characterized in that, Y=2 and X=4.

99. A method for replacing a valve by collapsing a suture, characterized in that, comprising: obtaining a replacement valve, the replacement valve comprising: An integrated stent frame, said integrated stent frame comprising a plurality of longitudinal struts and a plurality of circumferential struts, wherein said plurality of longitudinal struts and said plurality of circumferential struts form a tubular inner wall having a central cavity and an outer wall surrounding said tubular inner wall; A replacement leaflet valve, said replacement leaflet valve being located in the central cavity of said tubular inner wall and connected to said tubular inner wall; A plurality of rings connected to said integrated stent frame at equal intervals around the circumference of said integrated stent, wherein the relative positions of the rings are defined by a positive direction and a negative direction; Tying a first segment of a suture to a first anchoring ring; Passing the first segment of said suture in a first direction through a first X consecutive rings adjacent to said first anchoring ring, wherein X>0, skipping Y rings adjacent to said first X consecutive rings in said first direction, passing through Z consecutive rings in a second direction, wherein Z is 0 or greater than 1, and Z<X, and if Z=0, tying the first segment of said suture to the next consecutive ring in said first direction, or if Z>0, tying it to the next consecutive ring in said second direction; Passing a second segment of the suture in said first direction through a second X consecutive rings, skipping Y rings adjacent to said second X consecutive rings in said first direction, passing through Z consecutive rings in said second direction, wherein Z is 0 or greater than 1, and Z<X, and if Z=0, tying the second segment of said suture to the next consecutive ring starting from said second X consecutive rings in said first direction, or if Z>0, tying it to the next consecutive ring in said second direction; Passing a third segment of the suture in said first direction through a third X consecutive rings, skipping Y rings adjacent to said third X consecutive rings in said first direction, passing through Z consecutive rings in said second direction, wherein Z is 0 or greater than 1, and Z<X, and if Z=0, tying the third segment of said suture to the next consecutive ring starting from said third X consecutive rings in said first direction, or if Z>0, tying it to the next consecutive ring in said second direction.

100. The method according to claim 99, characterized in that, X=3, Y=1 and Z=0.

101. The method according to claim 99, characterized in that, X=4, Y=1 and Z=2.

102. The method according to claim 99, characterized in that, X≥2。 103. The method according to claim 100, characterized in that, X-Z=2.

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